VAERS_ID	RECVDATE	STATE	AGE_YRS	CAGE_YR	CAGE_MO	SEX	RPT_DATE	SYMPTOM_TEXT	DIED	DATEDIED	L_THREAT	ER_VISIT	HOSPITAL	HOSPDAYS	X_STAY	DISABLE	RECOVD	VAX_DATE	ONSET_DATE	NUMDAYS	LAB_DATA	V_ADMINBY	V_FUNDBY	OTHER_MEDS	CUR_ILL	HISTORY	PRIOR_VAX	SPLTTYPE	FORM_VERS	TODAYS_DATE	BIRTH_DEFECT	OFC_VISIT	ER_ED_VISIT	ALLERGIES	ORDER	SYMPTOMS	VACCINES	COUNTRY	Seriousness	Vaccine
0025023	07/09/1990	PA				M		pt has URI prior to onset of Guillian-Barre symptoms. He has rheumatoid arthritis & was receiving gold therapy concurrently. He was given the flu vaccine on 23Oct89									U	10/23/1989	12/07/1989	45		UNK	UNK	receiving gold therapy for rhematiod arthritis	URI	rhematoid arthritis	~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0025025	07/09/1990	FL				U		rash, pruritus									Y		01/10/1990			UNK	UNK	treated with Hydroxazine			~ ()~~~In patient		1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~9J01133~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0025030	07/09/1990	NY	66.0			F		Mylagias occurred within 3 days of immun. Seen on 4 additional occasions for continued pain & increasing eye/temporal pain.  Considered poss. meningoencephalitis due to vaccine. Admit to hosp for Guillain-Barre Synd. on 15Feb90.					Y				U	12/01/1989	12/03/1989	2		UNK	UNK	Lisinopril 20mg, Verapamil 120mg, HCTZ 25mg, Thyrolar			~ ()~~~In patient		1						1	Encephalitis; Guillain-Barre syndrome; Myalgia	FLU3~CONNAUGHT LABORATORIES~9F01202~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0025065	07/09/1990	NJ	20.0			F		Pt experienced tendinitis of the biceps brachii of her arm 10 days /p receiving influenza virus vaccine.									U	10/24/1989	11/03/1989	10		PVT	UNK			Diabetic & Cystic fibrosis	~ ()~~~In patient	B073089143	1						1	Injection site reaction; Tenosynovitis	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0025069	07/09/1990	MI	34.0			M		Pt developed hives 6 days /p receiving Influenza Virus vaccine. As of January 22, 1990, it was reported that he had recovered									Y	11/09/1989	11/15/1989	6		PVT	UNK			allery to penicillins & shell-fish	~ ()~~~In patient	B073089154	1						1	Rash; Urticaria	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0025070	07/09/1990	WI				M		Pt developed weakness in his arms and legs, DX as Guillain-Barre Syndrome /p receiving Influenza Virus Vaccine									U	11/21/1989				UNK	UNK				~ ()~~~In patient	B073090001	1						1	Guillain-Barre syndrome	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0025071	07/09/1990	MN				F		pt developed erythema, edema, warmth, itching, stinging & pain in approx. 4 X 6 area at site of injection /p receiving vaccine. Experienced flu-like symptoms. That include haedache, light-headedness, dizziness, nausea within 3 hrs /p vacc									U	10/27/1989	10/27/1989	0		PVT	UNK				~ ()~~~In patient	B073089142	1						1	Dizziness; Headache; Influenza; Injection site oedema; Injection site pain; Injection site reaction; Nausea	FLUX~PFIZER\WYETH~4898137~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0025074	07/09/1990	WA	73.0	73		F		Pt experienced severe pain & edema in lt arm from shoulder to hand, & fever /p receiving Influenza Virus. Symptoms persisted for approx. 2 wks & pt recovered									Y	11/06/1989	11/07/1989	1		PVT	UNK				~ ()~~~In patient	B073090004	1						1	Oedema; Pain; Pyrexia	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0025075	07/09/1990	NJ	43.0	43		F	11/09/1989	Pt experienced a local reaction within 24 hrs at the site of injection, described as a bullseye, after receiving influenza virus vaccine.  Also observed was supraclavicular swelling including lymph nodes.					Y			Y		11/07/1989	11/07/1989	0		PVT	UNK				~ ()~~~In patient	B073089147	1						1	Arthralgia; Arthritis; Back pain; Hypokinesia; Injection site hypersensitivity; Lymphadenopathy; Neck pain; Paraesthesia	FLUX~PFIZER\WYETH~4898169~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0025076	07/09/1990	OH	65.0			M		Pt became confused within a minute or two /p receiving Influenza Virus Vaccine. He became disoriented & could not remember the route to his home. Symptoms slowly abated within 3 days.									U					PVT	UNK				~ ()~~~In patient	B073089153	1						1	Confusional state	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0025171	07/09/1990	NJ				F		PT EXPER.ARTHRITIC PAIN AND POLYNEUROPATHY AFTER ADMIN OF INFLUENZA VIRUS VACCINE. REPORTER NOT SURE IF WYETH OF PARKE-DAVIS PRODUCT WAS USED.										12/01/1989	12/01/1989	0		PVT	PVT	NONE---IVV WAS A TRIVALENT A&B 1989-1990 FORMULA			~ ()~~~In patient	B073090037	1						1	Arthralgia; Neuropathy	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0025584	07/23/1990	FL	31.0			F		Pt developed Gullain-Barre Synd. characterized as ascending myopathy, myalgia & automic neuropathy, with bradycardia & flushing. Pt was hospitalized.					Y			Y	U	01/26/1990	02/20/1990	25	nerve conduction studies consistant w/Guillian- Barre synd.	PVT	UNK	Darachlor 4 tabs;			~ ()~~~In patient	894076003A	1						1	Asthenia; Bradycardia; Dizziness; Guillain-Barre syndrome; Hyperhidrosis; Influenza; Neuropathy; Tachycardia	FLUX~PFIZER\WYETH~4898139~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0025585	07/23/1990	CT				U		Nursing home pt developed an Influenza A Virus infection /p receiving Influenza Virus Vaccine									U	11/01/1989			Throat culture - positive for Influenza A Virus	PVT	UNK				~ ()~~~In patient	B073090055	1						1	Drug ineffective	FLUX~PFIZER\WYETH~4898141~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0025634	08/06/1990	CA				F		Pt received Fluogen within 30 min experienced coma & Hypoglycemia; Blood sugar 20 mg/100 ml; No other reports of this nature on the lot.									U	01/01/1989	11/30/1989	333	BS = 20mg/100ml	PVT	UNK	Vitamin B12 injections		pt was elderly /w a hx of pernicious anemia	~ ()~~~In patient	904089020	1						1	Coma; Hypoglycaemia	FLU3~PARKE-DAVIS~01889P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0025675	08/13/1990	MD	62.0			M		Pt received Influenza vaccine when awoke on the day after was in a semi-conscious state, grossly confused & weak; unable to recognize his wife or his doctor. This reaction has been previously reported to USP.					Y				Y	10/12/1989	10/13/1989	1		PVT	UNK	Prednisone, K-Lor, Lasix, Feledene, Bronkosol, NSS Nebulizer, Alupent Inhaler, Zaroxolyn		Pt has hx of connective tissue disorder	Pt has previously received Influenza vaccine every yr /w out rxn.~ ()~~~In patient	890211001B	1						1	Asthenia; Confusional state	FLUX~PFIZER\WYETH~4898171~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0025751	08/23/1990	AZ	63.0			F		Increasing, severe, generalized dermatitis of 2 wks duration. 1-2 days before onset received flu shot (Connaught) and Pnu-Imune.											11/15/1989			PVT	UNK	Hydroxizine, ASA			~ ()~~~In patient	8902657.01	1						1	Rash	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0025756	08/23/1990	CA	30.0			M		30 YO man developed erythema, tenderness & warmth below injection site 2 days after immunization.  Ellipsoid area 4X6CM, Injection site itself is clear.  Dx : Cellulitis vs injection site reaction.											01/10/1990			PVT	UNK			No hx of trauma to area. hx of recurrent pneumonia. lst pneumococcal vaccine	~ ()~~~In patient	9000065.01	1						1	Cellulitis; Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~256951~UNK~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0025862	09/07/1990	GA	91.0			F	09/04/1990	Pt vaccinated with Influenza experienced weakness of the lower extremities with aching progressing to the trunk and upper extremities - GBS. Pt hospitalized transferred to EUH for plasma exchange.							Y	Y	U	02/06/1990	02/25/1990	19		PVT	PVT	Hydrochlorothiazide 25 daily, Corgard 40 daily	Hypertension, ischemic heart disease		~ ()~~~In patient		1						1	Guillain-Barre syndrome; Myasthenic syndrome	FLUX~PFIZER\WYETH~9F01201C~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0026042	09/21/1990	NC				F		Pt vaccinated with Pneumovax/Influenza experienced an asthma attack which required a visit to a hospital ER & therapy with steroids.									U					UNK	UNK	Theophylline		COPD	~ ()~~~In patient	WAES89100945	1						1	Asthma	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0026046	09/21/1990	NY	34.0			F		Pt vaccinated with Pneumovax 23 developed severe swelling, erythema, pain & difficulty in moving her arm over the next 24 to 36 hrs. Also, developed a fever of 101.5 w/chills. Later presented w/moderate tenderness w/erythema.									U	11/06/1989	11/07/1989	1		UNK	UNK				~ ()~~~In patient	WAES89111057	1						1	Chills; Injection site reaction; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~44991~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0026048	09/21/1990	NY				U		Pt vaccinated with Pneumovax 23 developed pain, swelling & erythema at injection site; chills & fever. No further details wee provided.									Y	11/06/1989	11/07/1989	1		UNK	UNK					WAES89111080	1						1	Chills; Injection site reaction; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0026049	09/21/1990	NY				U		Pt vaccinated with Pneumovax 23 developed pain, swelling & erythema at inject site; chills & fever.									U	11/06/1989	11/07/1989	1		UNK	UNK				~ ()~~~In patient	WAES89111081	1						1	Chills; Injection site reaction; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0026050	09/21/1990	NY				U		Pt vaccinated with Pneumovax 23 developed pain, swelling & erythema at injection site; chills & fever.									U	11/06/1989	11/07/1989	1		UNK	UNK				~ ()~~~In patient	WAES89111082	1						1	Chills; Injection site reaction; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0026051	09/21/1990	NY				U		Pt vaccinated with Pneumovax 23/Influenza developed pain, swelling & erythema at injection site; chills & fever.									U	11/06/1989	11/07/1989	1		UNK	UNK					WAES89111083	1						1	Chills; Injection site reaction; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0026059	09/21/1990	CA				M		Pt vaccinated with Pneumovax 23/Influenza lt arm became weak due to brachial plexitis involving C-5.									U	10/31/1989	11/07/1989	7		UNK	UNK				~ ()~~~In patient	WAES89120574	1						1	Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0026125	09/28/1990	OH	88.0	88		M	09/24/1990	Pt vaccinated w/fluzone 21SEP90 on 24SEP90 pt granddght called ofc stating pt had been resting on Saturday & woke up with bilat leg numbenss that lasted 2 hrs then vanished. Pt up & walking with walker there after.									U	09/21/1990	09/22/1990	1		PVT	PUB	Quinidex, Theodur, Lasix, Isordil, Lanoxin		Coron Art. Dis., COPD	~ ()~~~In patient		1						1	Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0F11208~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0026159	10/02/1990	AZ	52.0			F		Pt vaccinated with FLUOGEN who has severe bronchial asthma seen in MD ofc well VS stable & chest clear, death & respiratory arrest.	Y	09/20/1990							N	09/20/1990	09/20/1990	0	HGT=5'6; WGT=99lbs; Morning of 20SEP90 BP=142/86;P=72/min&reg.	PVT	UNK	Methyprednisolone, Verapamil, Proventil, Albuterol, Anhydrous Theophylline	Severe Bronchial Asthma	Pt was hospitalized 2-3 yrs ago for hypertensive Crisis & Severe Bronchial Asthma.	~ ()~~~In patient	904090001	1						1	Apnoea	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0026223	10/12/1990	ID	62.0	61		F		Pt vaccinated with Flu Tirvalent experienced inflammation and itchyness at vaccine site.									Y	09/21/1990	09/21/1990	0		PVT	PVT				~ ()~~~In patient		1						1	Injection site reaction	FLUX~PFIZER\WYETH~4908192~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0070578	10/12/1990	PR				U																PVT	PVT				~ ()~~~In patient		1						1	Unevaluable event	DTP~UNKNOWN MANUFACTURER~~UNK~~~DTP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~UNK~~~HIB (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1	USA		Influenza
0026246	10/15/1990	FL	74.0	74		F	10/09/1990	Pt vaccinated with Fluzone developed itching eyes; welts on body; size of quarter for a few hrs. pt took chlor-trimton									Y	10/04/1990	10/05/1990	1		PVT	PVT	VB12 Cyanocobalmin; Voltaren 25mg		Shellfish	~ ()~~~In patient		1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~0F11209~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0026248	10/15/1990	MI	86.0	86		M	10/11/1990	Pt vaccinated with Fluzone became light headed legs & ears started to ache by the afternoon also headache. Felt a little funny soon after the vaccine. Rest, Tylenol, Fluids advised.									N	10/09/1990	10/09/1990	0		PVT	PUB	Cordizem; Seldane	SLight Sinus Drainage		~ ()~~~In patient		1						1	Dizziness; Ear pain; Headache; Myalgia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0F11210~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0026251	10/15/1990	PA	23.0	23		M	10/09/1990	Pt vaccinated with Influenza developed breathing difficulty, chocking snesatins. Given Epinphrine									Y	10/09/1990	10/09/1990	0		PVT	PVT				~ ()~~~In patient		1						1	Dysphagia; Dyspnoea	FLUX~PFIZER\WYETH~4908180~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0026302	10/17/1990	OK	62.0			F		Pt vaccinated with Influenza Vaccine development of Guillain Barre Synd had influenza vaccine on 21AUG90.					Y				U	08/21/1990	09/01/1990	11	CSF Protein 104	PUB	UNK	Bentyl, Zantac, Tylenol, Maalox, Centrium Vitamins		Plasmapheresis	~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0026281	10/19/1990	PA	79.0			M		Pt vaccinated with Influenza Vaccine developed Guillian Barres Synd progressive numbness & tingling both legs & hands weakness. Unsteady gait.							Y		U	10/04/1990	10/06/1990	2	EKG RBBB & Lafb; NA + 139, K 3.1, MGH 1.7, TH 09.2, BUN, Creat, GLC WNL ER 8 WBC 9.3 HIH 15.5/46.6 PLT 296	UNK	UNK	Theodur; Allopurinol; Hydrocholorthiazide			~ ()~~~In patient		1						1	Gait disturbance; Guillain-Barre syndrome; Myasthenic syndrome; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0026298	10/19/1990	AZ	4.0	4		M	10/10/1990	Fever 101.4 & Seizure. C/O feeling tired, has been less active than norm today. Pt had DTP, MMR, HIB, vacines yesterday.				Y					U	10/09/1990	10/10/1990	1		PVT	PVT				~ ()~~~In patient		1						1	Asthenia; Febrile convulsion	DTP~CONNAUGHT LABORATORIES~0F11096~UNK~~LL~DTP (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~0F11202~UNK~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~CONNAUGHT LABORATORIES~9A11072~UNK~~RL~HIB (PROHIBIT)~1|MMR~MERCK & CO. INC.~1500S~UNK~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|OPV~PFIZER\WYETH~61764~UNK~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~1	USA	Emergency room visit	Influenza
0026318	10/22/1990	AL	92.0			F	10/17/1990	Pt vaccinated with Influenza Trivalent A&B at 11:00AM on 9OCT90 fever noted at 8:00AM 11OCT90 Pt died 2:30AM 12OCT90.	Y	10/12/1990							N	10/09/1990	10/11/1990	2	All lab work WNL	PVT	PVT	Dipyridamold, Furosemide,Dioctolose, Chloraseptic, Methyldopa ,MOM, Aldomet	Rt lacunar Infarct Temp Area, Hypertens.	Rt Hemispheric stroke /w lt hemiparesis, lt facial weakness, aphasia, dysarthria, hypertension, limited ambulatory ability 2nd to stoke	~ ()~~~In patient		1						1	Pyrexia	FLU3~CONNAUGHT LABORATORIES~0F11216~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0026332	10/24/1990	DE	80.0	80		F	10/10/1990	Pt vaccinated w/Influenza Virus Vaccine experienced vertigo, slurred speech, & excessive sweating. Hospitalized & found to be severely hypoglycemic.					Y				U	10/08/1990	10/08/1990	0	Blood Glucose 22 mg/d1	PVT	PVT			No previous hx of hypoglycemia or hyperglycemia	~ ()~~~In patient	890284001B	1						1	Hyperhidrosis; Hypoglycaemia; Speech disorder; Vertigo; Hyperhidrosis; Hypoglycaemia; Speech disorder; Vertigo	FLUX~PFIZER\WYETH~4908181~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4908181~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0026398	10/30/1990	TX	54.0	54		M	10/22/1990	Pt vaccinated with Typhoid/Influenza at approx 1255PM on 13OCT90 presented in the ER @1655 on 13OCT90 BP 98/60, pulse 132, resp 24, temp 102.4, nausea, vomiting, myalgia & arthralgia.				Y					Y	10/13/1990	10/13/1990	0	WBC 2.8, HGB & HCT- WNL	MIL	MIL				~ ()~~~In patient		1						1	Arthralgia; Myalgia; Nausea; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0026457	11/02/1990	WA	46.0			F		Pt vaccinated /w Influenza developed nausea & myalgia; /p 16 hrs chest pain, sweats & chills. Taken to ER dx by ER as Panic Attack; was hypervent. Released after resp. normal.				Y					U	10/15/1990	10/15/1990	0	EKG=WNL	UNK	UNK				~ ()~~~In patient		1						1	Chest pain; Chills; Hyperhidrosis; Hyperventilation; Myalgia; Nausea	FLUX~PFIZER\WYETH~4908181~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0026463	11/02/1990	MI	62.0	62		F	10/17/1990	Pt dev flu-like resp sxs more than a wk /p being admin Flu vax. Pt expired, cause unknown, 16OCT90.  F/U 05NOV90:  PT WAS TERMINALLY ILL W/ MALIGNANT BRAIN TUMOR, DEV RESP COMPLICATIONS, SHALLOW BREATHING, T 101.8 & CONGESTION 12 D P/ VAX	Y	10/16/1990							N	10/01/1990	10/01/1990	0	CHEST X-RAY:  PNEUMONIA, BILAT BASILAR ATELECTASIS.  WBC 13,900/CU.MM.  LYMPHS = 9800/CU MM	PVT	OTH	NONE SPECIFIED	CANCER	PT WAS TERMINALLY ILL W/ MALIGNANT BRAIN TUMOR	~ ()~~~In patient	890291001B	1						1	Apnoea; Atelectasis; Hypoventilation; Influenza; Pneumonia; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~4908209~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0026490	11/05/1990	WI	36.0	36		F	10/24/1990	Pt vaccinated with Pneumococcal/Influenza developed local erythema& induration at inject site, sensation of tightness in throat; occurred 4 hrs after pt took Benadryl 50mg; tighness relieved; took 2nd dose in AM, size of erythema decreased.									Y	10/23/1990	10/23/1990	0		PVT	PVT	Pepcid; Lo-ovral		Hx similar response to flu vaccine last yr, no problem this yr when flue vaccine given in divided doses.	~ ()~~~In patient		1						1	Injection site reaction; Pharyngitis	FLUX~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~~1~SC~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0026491	11/05/1990	AZ	70.0	70		F	10/25/1990	Pt vaccinated with Flu shot developed redness, swelling,rash. Injection was given 22OCT90. Pt did not report rx until it was gone on 25OCT90.									Y	10/22/1990	10/22/1990	0		PVT	PVT	Lanoxin Thyroid			~ ()~~~In patient		1						1	Oedema; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0026497	11/05/1990	FL	53.0	53		F	10/29/1990	Pt vaccinated with Influenza/PNU-IMUNE approx 1 hr following administration of vaccine pt developed nausea, vomiting, fever lasting approx 12 hrs.									Y	10/25/1990	10/25/1990	0		PVT	PVT				~ ()~~~In patient		1						1	Nausea; Pyrexia; Vomiting; Nausea; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~01670P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~226928~1~IM~RA~PNEUMO (PNU-IMUNE)~1|FLU3~PARKE-DAVIS~01670P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0026504	11/06/1990	PA	66.0			F		Pt vaccinated with FLUOGEN developed sore throat, headache, earache, sinus drainage thru 22OCT90. Cough, congestion chest appt w/ Dr.  Given antibiotic & expectorant by MD dx URI. Symptoms not due to influenza injection.									U	09/26/1990	10/14/1990	18	Physical Exam only	UNK	UNK				~ ()~~~In patient		1						1	Cough; Ear pain; Headache; Pharyngitis; Sinusitis	FLU3~PARKE-DAVIS~01770P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0026497	11/07/1990	FL	53.0			F		Approx 1 hr /p vax of Parke Davis Influenza Vaccine Pt developed nausea, vomiting, fever lasting approx. 12 hrs.									U	10/25/1990	10/25/1990	0		PVT	UNK				~ ()~~~In patient		1						2	Nausea; Pyrexia; Vomiting; Nausea; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~01670P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~226928~1~IM~RA~PNEUMO (PNU-IMUNE)~1|FLU3~PARKE-DAVIS~01670P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0026596	11/08/1990	CA	80.0			F		Pt vaccinated with Influenza Vaccine 3-4 days after, pt had a seizure like episode at home, was found unresponsive and hospitalized. Admitted to ICU for 5 days. Treatment included oxygen and IV fluids. Discharged, admitted to Nursing Home.							Y		U	10/01/1990				UNK	UNK				~ ()~~~In patient	900180401	1						1	Convulsion; Encephalitis; Stupor	FLU3~LEDERLE LABORATORIES~289967~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation	Influenza
0026597	11/08/1990	CA	80.0			F		Pt vaccinated with Influenza Virus 3-4 days after vaccination, 80 yo woman found unresponsive, hospitalized. Pt had a seizure at home & another during hosp. Treatment included IV fluids. In ICU for 24 hrs dx altered level of consciousness.							Y	Y	U					UNK	UNK					900180402	1						1	Convulsion; Stupor; Thinking abnormal	FLU3~LEDERLE LABORATORIES~289967~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation,Disabling	Influenza
0026600	11/08/1990	TX	42.0			M		Pt vaccinated with Influenza Vaccine developed hives over entire body, low grade fever.									U	10/09/1990	10/09/1990	0	CBC	UNK	UNK	Diazepam; Biscodyl, Demerol		Spastic & dystomiquadraplegia, Cerebral palsy	~ ()~~~In patient		1						1	Urticaria	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0026605	11/09/1990	VA	75.0	75		M	11/01/1990	Pt vaccinated with Influenza vaccine developed temp 103; chills, Seen in ER that PM given Tylenol and labs done.				Y					Y	10/30/1990	10/30/1990	0	WBC 9000;  BS 370;   UA - negative	PVT	PVT			Diabetes	~ ()~~~In patient		1						1	Chills; Pyrexia	FLU3~CONNAUGHT LABORATORIES~OF11200~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0026332	11/12/1990	DE	80.0			F	10/10/1990	Pt vaccinated with FLU Vaccine developed vertigo, slurred speech, & excessive sweating following immunization was hospitalized & found to be severely hypoglycemic.					Y				U	10/08/1990	10/08/1990	0	Blood Glucose 22 mg/d1	PVT	PVT			No previus hx of hypoglycemia or hyperglycemia	~ ()~~~In patient	890284001B	1						2	Hyperhidrosis; Hypoglycaemia; Speech disorder; Vertigo; Hyperhidrosis; Hypoglycaemia; Speech disorder; Vertigo	FLUX~PFIZER\WYETH~4908181~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4908181~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0026614	11/13/1990	MI	44.0	44		F	11/03/1990	Pt vaccinated with Influenza Vaccine became itchy in area lt arm; hard in area; sl swollen, red & warm started evening 1NOV90 has continued stated less red & swollen today 3NOV90.									N	11/01/1990	11/01/1990	0		OTH	OTH	Ogen			~ ()~~~In patient		1						1	Injection site mass; Injection site reaction	FLUX~PFIZER\WYETH~4908509~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0026615	11/13/1990	OH	49.0	49		M	11/05/1990	Pt vaccinated with Influenza Virus developed rash over trunk started 1NOV90, itches, temp 99.4. Rx Deltasone dose pack.									U	10/25/1990	11/01/1990	7		OTH	PVT	Ascriptin, Sectal		Previous allergic rx to B/P med	~ ()~~~In patient		1						1	Herpes zoster; Pruritus; Pyrexia; Rash	FLUX~PFIZER\WYETH~4908192~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0026619	11/13/1990	AZ	54.0	54		F	11/06/1990	Pt vaccinated next day redness 2in X 1 1/2in, 1/4in raised, hard not reported until 2NOV90 still red 6NOV, swelling down. Pt was unsure if nausea was from injection or from her ulcer.									Y	10/31/1990	11/01/1990	1		PVT	PVT	Tenormin, Prop	Peptic Ulcer, Back Pain	Lower back (L3, L4) surgery 2OCT90  Demerol in Hosp.	~ ()~~~In patient		1						1	Injection site mass; Injection site reaction; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0026637	11/14/1990	IA				M		Pt vaccinated with Pneumococcal/Influenza developed symptoms of Bell's Palsy. Prior to onset of Bell's Palsy, pt had myalgia, mild pain in the neck & generally not feeling quite right.								Y	U	09/27/1990				UNK	UNK			Prior to onset of Bell's Palsy, pt had been aware of some myalgia & just not feeling quite right, also experienced mild pain in the neck.	~ ()~~~In patient	900190501	1						1	Facial palsy; Myalgia; Neck pain	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~268982~UNK~~~PNEUMO (PNU-IMUNE)~1	USA	Disabling	Influenza
0026638	11/14/1990	WA	21.0	21		F	11/12/1990	Pt vaccinated with Influenza A/B first time  got flu shot. General malaise, headache, fatigue, cold, clammy.				Y					Y	11/09/1990	11/09/1990	0		UNK	UNK	Vit C, Zantac, A cyclored			~ ()~~~In patient		1						1	Asthenia; Chills; Headache; Hyperhidrosis; Malaise	FLUX~PFIZER\WYETH~02280P~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0026639	11/14/1990	WA	39.0	39		F	11/14/1990	Pt vaccinated wih Influenza A/B throat constricting, tightness in chest, anxiety.				Y					Y	11/09/1990	11/09/1990	0		UNK	UNK			Allergic to house dust & pollen.	~ ()~~~In patient		1						1	Anxiety; Chest pain; Laryngospasm	FLU3~PARKE-DAVIS~00280P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0026640	11/14/1990	WA	38.0	38		F	11/14/1990	Pt vaccinated with Influenza A/B experienced shortness of breath.				Y					Y	11/09/1990	11/09/1990	0		OTH	PVT			Environmental seasonal allergies	~ ()~~~In patient		1						1	Dyspnoea	FLU3~PARKE-DAVIS~02280P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0026641	11/14/1990	WA	44.0	44		F	11/13/1990	Pt vaccinated with Influenza A/B chest tightness & pain. sore & hoarse throat.				Y					Y	11/09/1990	11/09/1990	0		UNK	PVT			Old reaction to ampicillin.	~ ()~~~In patient		1						1	Chest pain; Pharyngitis	FLU3~PARKE-DAVIS~02280P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0026655	11/15/1990	MI	65.0			F		Pt vaccinated with Fluzone 1 wk after injection,  had sudden death. 1 & 2 days before death  c/o  fatigue, low back pain and upper shoulder pain.	Y								N	10/18/1990	10/25/1990	7		UNK	UNK	Calan SR 240MG 1/2 tab daily.		Hx of hypertension, cigarette smoking.	~ ()~~~In patient		1						1	Asthenia; Back pain	FLU3~CONNAUGHT LABORATORIES~0F112117~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0026667	11/16/1990	IL	80.0	80		F	10/30/1990	Pt vax w/ flu dev diarrhea & abd cramps two days after vax. Hosp X 4 days; dx = gastroenteritis w/ resultant hypovolemia.  Pt also dev fever.  Sxs resolved.					Y				U	10/18/1990	10/20/1990	2		PVT	PVT				~ ()~~~In patient	890303005B	1						1	Abdominal pain; Asthenia; Diarrhoea; Gastroenteritis; Hypovolaemia; Nausea; Pyrexia	FLUX~PFIZER\WYETH~4908196~4~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0026669	11/16/1990	OH	39.0	39		M	11/12/1990	Pt vaccinated with Influenza developed nausea, headache, swelling in eyes & face, fever & chills. Treated w/Benadryl & Prednisone.									Y	11/05/1990	11/05/1990	0		PVT	PVT	Librium, Tenex, Aspirin, Procardia XL		Alcoholism, hypertension, coronary artery dis, demerol allergy causes Increased BP	~ ()~~~In patient		1						1	Chills; Face oedema; Headache; Nausea; Pyrexia	FLU3~PARKE-DAVIS~02580P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0026670	11/16/1990	TX	56.0	56		F	11/06/1990	Pt vaccinated with Influenza, next day had redness, increased swelling 2 1/4 X 3 1/4 X 1/4 induration - MD called.									U	11/01/1990	11/02/1990	1		UNK	UNK				In Pt swelling FLU-DTP~ ()~~0.00~In Patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site reaction	FLUX~PFIZER\WYETH~4908196~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0026672	11/16/1990	NJ	39.0	39		F	11/12/1990	Pt vaccinated with Influenza developed painful red swelling ultimately developed abscess. Treatment Topicort apply tid, Keflex 50  mg, Buferin, Keflex PRN 500MG.									Y	10/08/1990	10/08/1990	0	Cephalothin LE 8 susceptible	PVT	PVT	Valium, Modiuretic, Nubain, Pericolace, Surtak, Theragram, Lioresol, Dilantin	Routine check up	MS, Chronic UTI	~ ()~~~In patient		1						1	Injection site abscess; Injection site reaction	FLUX~PFIZER\WYETH~4908180~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0070576	11/16/1990	NC	76.0	76		M	11/12/1990	vax was given intravenously through dialysis blood tubing as an IV push med;pt had no complaints; no adverse signs/sxs;										10/15/1990			none	PVT	PVT	calcijex, epogen;	end stage renal disease,2d nephroscle	dialysis	~ ()~~~In patient		1						1	Unevaluable event	FLUX~PFIZER\WYETH~4908189~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0026681	11/19/1990	OH	47.0	47		F	11/13/1990	24 hrs after inject arm became reddened large whelt silver dollar in size red-itchy and sore to touch lasting 4 days.									Y	11/05/1990	11/06/1990	1		PVT	PVT				~ ()~~~In patient		1						1	Injection site reaction	FLUX~PFIZER\WYETH~4908194~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0026703	11/21/1990	NY	25.0	24		F	11/06/1990	Pt vaccinated with Influenza vaccine developed diarrhea, flu-like symptoms, rash, fatigue, nausea, fever.									Y	10/31/1990	11/02/1990	2		PVT	OTH				~ ()~~~In patient		1						1	Asthenia; Diarrhoea; Influenza; Nausea; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~0F11221~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0026708	11/21/1990	NY	44.0	44		M	11/08/1990	Pt vaccinated with FLU developed fever, chills & sweating, cough, runny nose.									Y	11/07/1990	11/07/1990	0		PVT	PUB				In pt at 38yo flu.~ ()~~~In patient		1						1	Chills; Cough; Hyperhidrosis; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0026709	11/21/1990	CA	79.0	79		F	11/02/1990	Pt vaccinated Pnuemococcal/FLU rt arm now swollen, wrist to shoulder. No known allergies.									Y	11/01/1990	11/01/1990	0		PUB	PUB				~ ()~~~In patient	CA903	1						1	Oedema; Pain	FLU3~CONNAUGHT LABORATORIES~11203~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~285909~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0026711	11/21/1990	CA	63.0	63		M	11/09/1990	Pt vaccinated with Fluzone developed facial swelling seen on 19OCT90 face was red with periorbital swelling. Benadryl 25 mg 1 or 2 caps every 8 hours.									Y	10/18/1990	10/18/1990	0		PUB	PUB				~ ()~~~In patient	CA901	1						1	Face oedema	FLU3~CONNAUGHT LABORATORIES~0F11203~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0026712	11/21/1990	MI	58.0			F		Pt vaccinated with Influenza developed Lt Bell's Palsy.									U	10/16/1990	10/17/1990	1		UNK	UNK	Mixed beef & Pork insulin; Maxzide		Hematochromatosis, Diabetes, Cirrhosis, Hypertension	~ ()~~~In patient		1						1	Facial palsy	FLU3~CONNAUGHT LABORATORIES~OF11211~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0026713	11/21/1990	MD	77.0			M		Pt vaccinated with Fluogen 10-2-90 & on 10-7-90 had nausea. On 10-8-90, had dyspnea & a lump in his chest  seen in ER; Dx as having RLL infiltrate & R/O AMI. Had respiratory failure & cardiac arrest & died on 10-9-90.	Y	10/09/1990			Y				N	10/02/1990	10/02/1990	0		UNK	UNK			Pt hx of COPD, CABG, Chronic renal fialure, had flu shots in the past without problems.	~ ()~~~In patient	904090003	1						1	Apnoea; Cardiac arrest; Pneumonia; Shock	FLU3~PARKE-DAVIS~02580P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0026716	11/26/1990	CO	53.0			F	11/15/1990	Pt vaccinated with Influenza c/o severe neck & throat pain spreaded down resulting in generalized weakness & arm numbness. Admitted to hosp w/proximal weakness & difficulty swollowing & paralysis. Probable GBS.			Y	Y	Y				N	10/24/1990	11/05/1990	12	Elevated CSF protein	OTH	OTH				~ ()~~~In patient		1						1	Asthenia; Dysphagia; Guillain-Barre syndrome; Neck pain; Pain; Paraesthesia; Paralysis	FLUX~PFIZER\WYETH~4908201~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0026720	11/26/1990	AZ	70.0	70		F	11/16/1990	Pt vaccinated with Influenza developed tender hot (fire) feeling in lt arm, redness in arm at site of injection. Abscess formed advised by MD to apply hot compresses & Bactorban ointment. Abscessed drained on own.				Y					N	10/11/1990	10/11/1990	0		OTH	PUB	Lopressor		HTN	~ ()~~~In patient	AZ9001	1						1	Injection site abscess; Injection site reaction	FLU3~CONNAUGHT LABORATORIES~0F11208~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0026721	11/26/1990	IA	71.0	71		M	11/14/1990	Pt vaccinated with Influenza developed funny feeling in both lower extremities, clumsy with both legs which feel numb and tingly. BP 180/100. Rest of exam  negative. Lungs are clear. Reflexes diminished. IMP: possible GBS.	Y			Y	Y				U	10/24/1990	11/02/1990	9	Referred to McKennon Hosp for neurology evaluation.	PVT	PVT				~ ()~~~In patient		1						1	Gait disturbance; Guillain-Barre syndrome; Hypertension; Paraesthesia; Guillain-Barre syndrome; Hypertension; Paraesthesia	FLUX~PFIZER\WYETH~4908187~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4908187~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Results in Death	Influenza
0026722	11/26/1990	CO	37.0	36		M	10/30/1990	Pt vaccinated with Influenza, fainting, BP 56/30, pulse weak thready 96. No redness swelling at site of injection. Given Epinephrine.				Y					U	10/17/1990	10/17/1990	0		PUB	OTH				~ ()~~~In patient		1						1	Asthenia; Dizziness; Hypotension	FLU3~CONNAUGHT LABORATORIES~0F11210~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0026723	11/26/1990	CO	42.0	42		F	10/30/1990	Pt vaccinated with Influenza c/o weakness, dizziness, slight itching at injection site. No redness, swelling. BP 80/40 P84 strong, regular. Within 5 min c/o increasing weakness, SOB, dizziness.				Y					Y	10/17/1990	10/17/1990	0		PUB	PVT				~ ()~~~In patient		1						1	Asthenia; Dizziness; Dyspnoea; Hypotension; Pruritus	FLU3~CONNAUGHT LABORATORIES~0F11210~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0026729	11/26/1990	MS	68.0	68		M	11/05/1990	Pt vaccinated with Fluogen approx 15 min after receiving vaccine pt c/o dizziness, weakness, excessive perspiring, nausea. vomited X 2; BP 140/80, P80 Reg, BS 150.									Y	11/02/1990	11/02/1990	0		UNK	UNK	Cardizem, Axid, Carafate		HTN, Cardiovascular		MS901	1						1	Asthenia; Dizziness; Hyperhidrosis; Nausea; Vomiting	FLU3~PARKE-DAVIS~01770P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0026721	11/27/1990	IA	71.0	71		M	11/14/1990	Pt vaccinated with Influenza developed funny feelings in both lower extremities. Pt is quite clumsy w/both legs they feel numb & tingly & dont seem to work well. Possible GBS.				Y	Y				N	10/24/1990	11/02/1990	9		PVT	PVT				~ ()~~~In patient		1						2	Gait disturbance; Guillain-Barre syndrome; Hypertension; Paraesthesia; Guillain-Barre syndrome; Hypertension; Paraesthesia	FLUX~PFIZER\WYETH~4908187~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4908187~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0026803	11/27/1990	MA	79.0	79		M		Pt vaccinated with Influenza experienced low grade fever, cough, sx persist & atrial flutter fib, admitted to hosp w/pneumonia, CHF.				Y	Y				U	11/01/1990	11/02/1990	1	CSR & CBC - normal 6NOV90	PUB	PUB	Isordil, Cardizem, Kerlone		HBP, coronary ischemia	~ ()~~~In patient		1						1	Atrial flutter; Cough; Myalgia; Pericarditis; Pneumonia; Pyrexia; Right ventricular failure	FLU3~CONNAUGHT LABORATORIES~0F11224~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0026808	11/27/1990	MI	37.0	37		F	11/18/1990	Pt vaccinated with Influenza developed stiffness in neck, headache.				Y					Y	10/18/1990	10/18/1990	0		PVT	PVT				~ ()~~~In patient		1						1	Headache; Nuchal rigidity	FLUX~PFIZER\WYETH~4908188~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0026818	11/27/1990	WA	30.0	30		M	11/16/1990	Pt vaccinated with Typhoid/Fluzone developed swollen lt arm elbow to shoulder, hot to touch, not too painful. Pt did not apply ice packs as directed when vaccinated nor take ASA or Tylenol. This is the 2nd of this series.									Y	11/13/1990	11/14/1990	1		MIL	MIL				~ ()~~~In patient		1						1	Oedema; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~PFIZER\WYETH~4898176~2~SC~LA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0026819	11/27/1990	OH	33.0	33		F	11/13/1990	Reporter is MD states would have required Dr visit if wasn't an MD. Vaccinated with Influenza developed slight soreness at site 6 hrs later. 24hrs later mild swelling, erythema 3 diameter & pruritis.									N	11/12/1990	11/13/1990	1		PVT	PVT			Allergies Aspirin, Keflex, topical Iodine allergies.	~ ()~~~In patient		1						1	Injection site reaction	FLUX~PFIZER\WYETH~4908194~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0026822	11/27/1990	OK	44.0	44		F	11/19/1990	Pt vaccinated with Fluogen/Engerix developed puffy below eyes, blotchy patches on shoulder & legs, felt like fever, stiff neck started morning after & lasted 1 wk red color around neck									Y	10/29/1990	10/30/1990	1		PUB	PVT				~ ()~~~In patient		1						1	Face oedema; Nuchal rigidity; Pyrexia; Rash	FLU3~PARKE-DAVIS~01870P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0026826	11/27/1990	CA	25.0			F	10/23/1990	Pt vaccinated with Fluzone developed painful stiff neck x5 days; No fever or other symptoms; No muscle ache or sensory nerve changes noticed.									U	10/19/1990	10/20/1990	1		UNK	UNK			allerigc to ibuprofen, sulfa drugs	~ ()~~~In patient		1						1	Nuchal rigidity	FLU3~CONNAUGHT LABORATORIES~0F11217~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0026837	11/28/1990	CO	79.0	79		F	11/15/1990	Pt vaccinated with Influenza developed vasculitis described as severe rash on her arms & legs. Also experienced pain & vomiting.			Y		Y	10			N	10/25/1990	11/01/1990	7		PVT	PVT	Synthroid, Aldactazide	none		Vasculitis 1 wk /p previous vax of Influenza 89-90 formula~ ()~~~In patient	890311001B	1						1	Gastrointestinal haemorrhage; Pain; Pleural effusion; Rash; Splenomegaly; Vasculitis; Vomiting	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0026838	11/28/1990	AZ				U	11/15/1990	Pt vaccinated with Influenza developed adult respiratory distress synd following administration of Influenza Virus Vaccine. Considered to be life threatening.			Y						U				Chest x-ray: Pleural effusion	PVT	PVT				~ ()~~~In patient	890311002B	1						1	Respiratory disorder	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0026839	11/28/1990	AZ	55.0			M	11/16/1990	Pt vaccinated developed swelling-lips, face lt arm & lt hand. Seen in ER 13NOV90. Vsikeril injection in ER Hydroxyzine pam 50mg TID x 7 days. Seen in MD office 15NOV90 for f/u				Y					Y		11/12/1990			PVT	PVT	Nasalide, Zejtril	HTN	Duricef, Novacain, Feldene, Reglan			1						1	Face oedema; Oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0026843	11/28/1990	PA	82.0			F		Pt vaccinated with Influenza developed swelling in lt arm w/low grade temp. Treated as allergic reaction w/short course Prednisone. Developed sterile abscess & fevers. Required hospitalization & surgery drainage .							Y		U	10/08/1990	10/10/1990	2	Blood culture - negative; abscess culture - negative	UNK	UNK	Calan SR			~ ()~~~In patient		1						1	Abscess; Oedema; Pyrexia	FLUX~PFIZER\WYETH~4908205~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0026844	11/28/1990	WA				F		Pt vaccinated with FLUOGEN developed Stevens-Johnson Synd. No other details known.									U	09/01/1990	09/01/1990	0		UNK	UNK				~ ()~~~In patient	904090004	1						1	Stevens-Johnson syndrome	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0026861	11/30/1990	CA	37.0	37		F	11/16/1990	several minutes after injection on deltoid developed large wheal, vessicles, pruritis & associated w/global headache. Rx Benadryl & hydrocortisone cream. Headache, pruritus urticaria									Y	11/06/1990	11/06/1990	0		UNK	UNK	Demulen; Ceclor, Caleen.		Atopic allergic synd. Mitial valve prolapse-sinusits			1						1	Headache; Pruritus; Urticaria	FLU3~PARKE-DAVIS~02580P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0026862	11/30/1990	MA	69.0	69		M	11/26/1990	Pt vac w/ flu vac developed weakness and mild numbness in torso lasting seven days. Denies difficulty breathing has not had prior reactions to Flu vaccine. 14Feb91:  Neurologist comment, insufficient evidence to relate sx to flu shot.				Y					Y	11/08/1990	11/08/1990	0		UNK	UNK	Doxepin HCL, Hytrin, Dipyradimole		Hypertension	~ ()~~~In patient	MA900001	1						1	Asthenia; Malaise; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0F11223~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0026863	11/30/1990	MA	72.0	72		M	11/26/1990	Pt vaccinated with Influenza seven days following flu shot, developed severe gastroenteritis & chest pain. Physical exam revealed no cardiac involvement, gastroenteritis relieved by antacid. No unusual food taken; wife not ill and ate same				Y					Y	10/31/1990	11/07/1990	7	EKG - WNL	PUB	PUB				~ ()~~~In patient	MA900002	1						1	Chest pain; Gastroenteritis	FLU3~CONNAUGHT LABORATORIES~0F11224~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0026864	11/30/1990	MA	58.0	58		F	11/15/1990	Pt vaccinated with Influenza nine days following injection, pt developed fever up to 104, chills & mild gastroenteritis. No other URI complications. Symptoms persist to date.				Y					Y	11/01/1990	11/10/1990	9		PUB	PUB				~ ()~~~In patient	MA900003	1						1	Chills; Gastroenteritis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0F11224~1~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0026865	11/30/1990	MA	56.0	56		F	11/26/1990	Pt vaccinated with Influenza approx 1 hr later developed severe chills, headache & muscle aches lasting two days.				Y					Y	10/24/1990	10/24/1990	0		PUB	PUB	Lasix, Meorol, Vasotec, Trendate, Lithium, Clonipin, Synthyroid, Coumadin.	Lupus, HTN, Depression	HTN, Hypothyroid, Depression, Angina	~ ()~~~In patient	MA900004	1						1	Chills; Headache; Myalgia	FLU3~CONNAUGHT LABORATORIES~0F11216~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0026866	11/30/1990	MA	71.0	71		M	10/27/1990	Pt vaccinated with Influenza four days following injection, pt stated I had red spots on my face, followed by a generalized facial rash on day five & swelling of the face on day six.				Y					Y	10/23/1990	10/27/1990	4	Given Seldane Anhydroxizine	PUB	PUB				~ ()~~~In patient	MA900005	1						1	Face oedema; Rash	FLU3~CONNAUGHT LABORATORIES~0F11226~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0026871	12/03/1990	MI	77.0	77		F	11/02/1990	Pt vaccinated with Influenza red edematous area noted at injection site 3 min after injection. Pt did not bleed at time of injection or later- no bandage applied. Pt denies all questioned possible rxn- local & systemic (itching, dizzy).									N	11/02/1990	11/02/1990	0		PUB	PUB			Diabetic, Arthritis, Hypertension	~ ()~~~In patient	MI9002	1						1	Injection site reaction	FLUX~PFIZER\WYETH~4908208~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0026875	12/03/1990	CO				U		Pt vaccinated developed back pain 2 wks after & progressive weakness & numbness about 3 wks later.				Y	Y				N				Negative head, neck & thoracic CT; increased CSF (protein 179), NCV c/w neuropathy.	UNK	UNK				~ ()~~~In patient		1						1	Asthenia; Back pain; CSF test abnormal; Neuropathy; Paraesthesia	FLUX~PFIZER\WYETH~4908201~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0026880	12/03/1990	NY	44.0	44		F	11/24/1990	Pt vaccinated with Influenza lt arm felt sore & noted headache in the region & bilateral neck pain posterior. Also noted chills - did not take temp pt woke up feeling as if couldn't breathe & had a cement block on chest.				Y					Y	11/19/1990	11/19/1990	0		OTH	PUB	Coumadin, Premarin, Ativan, Emycin,Ampicillin		Codeine, open heart surgery for dysfunctional aortic valve 3/90	~ ()~~~In patient		1						1	Chest pain; Chills; Cough; Dyspnoea; Headache; Injection site pain; Neck pain; Paraesthesia; Rhinitis; Vomiting	FLU3~CONNAUGHT LABORATORIES~0F11221~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0026888	12/04/1990	CA	80.0	80		F	11/27/1990	Pt vaccinated with Pnu-Imune 23/Influenza developed minor rash; MD notified dx serum sickness, temp 100.1 (R); Pt w/vascular macular erythematous eruptions over extensor surfaces large joints. Treatment: Diphenhydramine & APAP.				Y					Y	11/26/1990	11/26/1990	0		MIL	PUB	Temezepam, Cefaclor, Furosemide, DSS KCL 10% Soln; Haldol, Nimotop	s/p Subarachnoid hemmorhage Parkinsons	Subarachnoid Hemmmorhage, Parkinsons Disease; CVA;	~ ()~~~In patient		1						1	Pyrexia; Rash; Serum sickness	FLUX~PFIZER\WYETH~4908201~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~287906~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0026895	12/04/1990	RI	80.0			F		Pt vaccinated with Influenza developed nausea & vomiting for 3 days. Vaccine received on 14OCT pt seen in ER on 11OCT, sent home and admitted to hosp on 17OCT.					Y				U	10/14/1990	10/14/1990	0		UNK	UNK	Darvon, Tranxene, Zantac, Bentyl, Iron supplements.			~ ()~~~In patient		1						1	Nausea; Vomiting	FLUX~PFIZER\WYETH~4908183~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0026896	12/05/1990	PA				U	11/30/1990	Pt vaccinated with Fluzone developed temp. not recorded, but believed to be over 37 chills, weakness, asthma worsened.					Y				Y					UNK	UNK				~ ()~~~In patient	CO3707	1						1	Asthenia; Asthma; Chills; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4918P2~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0026897	12/05/1990	PA				U	11/30/1990	Pt vaccinated with Fluzone developed asthenia, chills, fever.									Y					OTH	OTH				~ ()~~~In patient	CO3708	1						1	Asthenia; Chills; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4918P2~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0026899	12/05/1990	CA	40.0	40		F	11/19/1990	Pt vaccinated with FLU/TD developed headache, itching throat, weak, tight chested & SOB.				Y					U	11/15/1990	11/18/1990	3		PUB	UNK	Ampicillin, Sudafed, Ear drops, Pain med	Ear infection that was reportedly clear		~ ()~~~In patient	CA907	1						1	Asthenia; Dyspnoea; Headache; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~0F11203~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SCLAVO~136A1~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0026900	12/05/1990	CA	46.0	46		F	11/05/1990	Pt vaccinated with Influenza rash on chest, SOB, fever 100.6F, swelling of rt shoulder and rt knee to calf, 1 day diarrhea.				Y					Y	10/29/1990	10/30/1990	1		PUB	PUB	Vasotac 10mg, Estrogen		allergic-PCN; hx of hypertension	~ ()~~~In patient	CA908	1						1	Diarrhoea; Dyspnoea; Oedema; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~0F11203~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0026902	12/05/1990	CA	35.0	35		F	11/15/1990	Pt vaccinated with Influenza/Pneumococcal/TD developed numbness, tingling of lt side of body (arm upward to back, & down leg rt side (arm & leg) also have intermittant numbness & tingling.				Y					N	11/14/1990	11/14/1990	0		PUB	PUB	Seldane	Sinus/cold prior, 0 fever	Denied, except wind/pollens	~ ()~~~In patient	CA906	1						1	Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0F11203~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~285909~1~IM~~PNEUMO (PNU-IMUNE)~1|TD~SCLAVO~110A1~UNK~IM~~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0026903	12/05/1990	CA	78.0	78		M	11/16/1990	Pt vaccinated with Influenza developed runny nose, coughing, slight temp 99-100, congestion of sinus & lungs saw MD who supposedly dx'd Ix reaction.				Y					U	10/30/1990	11/09/1990	10		PUB	PUB	Xyloprim, Keftab & cough syrup		kidney stones	~ ()~~~In patient	CA904	1						1	Cough; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0F11203~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0026904	12/05/1990	CA	67.0	67		M	11/15/1990	Pt vaccinated with Pneumonia/FLU developed swelling of arm progressed down arm to the wrist. The rt arm is red, hot, swollen, & painful to move. Red streak from arm pit rt to elbow, feels sluggish.									U	11/14/1990	11/14/1990	0		PUB	PUB				~ ()~~~In patient	CA905	1						1	Hypokinesia; Injection site reaction; Oedema; Pain	FLU3~CONNAUGHT LABORATORIES~0F11203~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~285909~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0026908	12/06/1990	FL	34.0	33		M	11/20/1990	Pt vax /w Fluogen developed flushing sensation, red face, c/o nausea, vomited x 2. Red raised rash covered trunk, face, & ears with splotchy rash on arms. Vomit X 2, sent to ER.				Y					Y	11/15/1990	11/15/1990	0	ABG's	OTH	PVT	Vitamins, Slim Fast		Penicillin/Ampicillin	~ ()~~~In patient		1						1	Nausea; Rash; Vasodilatation; Vomiting	FLU3~PARKE-DAVIS~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0026934	12/10/1990	WA	41.0	40		F	11/28/1990	Pt vaccinated with Influenza developed rash starting under lft arm (side vaccine was given on); rash spread over both arms, back, & abd. Skin appears scalded w/blistery areas; reaction systemic. Referred to ER.				Y					Y	11/26/1990	11/26/1990	0		PUB	PUB				~ ()~~~In patient	WA9000491	1						1	Dermatitis bullous	FLU3~PARKE-DAVIS~01770P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0026935	12/10/1990	WA	31.0	31		M	11/07/1990	Pt vaccinated with Influenza developed local rxn: swelling, warmth, redness began 15 days after injection. Knot and redness lasted 4 days. Also, systemic rxn: cough, fever (not taken), sore throat, rhinitis began 15 days after injection.									Y	10/15/1990	10/30/1990	15		PUB	PUB			anaphylactic reaction to nuts; hx asthma	~ ()~~~In patient	WA9000484	1						1	Cough; Injection site mass; Injection site reaction; Pharyngitis; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~4908181~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0026937	12/10/1990	PA	56.0	56		M	11/14/1990	Pt vaccinated with Influenza 1NOV90. On 2NOV90 developed pain in ear, traveling to jaw, then to throat; lasted until 4NOV90. Returned 14NOV90.									Y	11/01/1990	11/02/1990	1		PUB	PUB	Isordil; Vasotec; Aspirin; Cardizem		CHF, Kidney Failure	~ ()~~~In patient	PA904	1						1	Ear pain; Pain; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~0F11223~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0026940	12/10/1990	MN	77.0	77		F	11/30/1990	Pt vaccinated with Influenza developed pain in lower extremities, numbness of lower abdomen, unstable gait, incontinence of bladder/bowel.					Y	12			N	11/02/1990	11/03/1990	1	Neurology Consultation = post vaccination myelopathy	PVT	UNK		Annual physical	ASHD COPD	~ ()~~~In patient		1						1	Faecal incontinence; Gait disturbance; Pain; Paraesthesia; Urinary incontinence	FLU3~CONNAUGHT LABORATORIES~0F11222~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0026941	12/10/1990	CO	68.0	67		F	12/03/1990	Pt c/o of hand/arm & neck pain, thought to be due to Procan intoxication , admitted to hosp. secondary to this Dx & developed progressive weakness once in hosp. Currently in ICU			Y	Y	Y				N	10/17/1990	11/21/1990	35	deceased reflexes & weakness	OTH	OTH	Procane, Digoxin, Tenormin		intermittant A-Fib, CHF, NKDA	~ ()~~~In patient		1						1	Asthenia; Headache; Hyporeflexia; Neck pain	FLU3~CONNAUGHT LABORATORIES~OF11210~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0026961	12/11/1990	IL	70.0	69		M	12/03/1990	Pt vaccinated with FLUZONE developed high fever 103+, aching, chills. No other sx. Did develop cough.									Y	11/09/1990	11/11/1990	2		PVT	PVT	Lasix, Motrin, Lanoxin, Captopril, potassium	compensated CHF & HTN		~ ()~~~In patient		1						1	Chills; Cough; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0F11202~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0026967	12/12/1990	CA	58.0	58		F	11/14/1990	Pt vaccinated with FLU developed induration & erythema w/pain at injection site approx 7 days after injection. Was referred to ER by PMD for evaluation. Aspiration was attempted;no aspirant. Dx: localized reaction to vaccine.				Y					Y	11/02/1990	11/09/1990	7		PUB	PUB				~ ()~~~In patient	CA9011	1						1	Injection site reaction	FLU3~CONNAUGHT LABORATORIES~0F11202~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0026968	12/12/1990	CA	84.0	84		M	11/19/1990	Pt vaccinated with flu developed severe pain w/swelling of lt wrist. Injection site was sore to touch only. Saw MD; patient told he developed arthritis in lt wrist, secondary to flu vaccine. Was advised not to have flu vaccine in future.				Y					Y	11/09/1990	11/09/1990	0	PMD did laboratory assessment	UNK	UNK					CA9012	1						1	Arthralgia; Arthritis; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0F11202~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0026970	12/12/1990	CA	76.0	76		F	11/20/1990	Pt vaccinated with FLU/Pneumoccoccal developed queasiness, N/V, diarrhea x 2-3hrs, chills, & dizziness x 1wk. Was kept in the infirmary at convelescent home for 3 days.									Y	11/01/1990	11/02/1990	1		PUB	PUB	water pills			~ ()~~~In patient	CA9014	1						1	Chills; Diarrhoea; Dizziness; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~0F11203~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~285909~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0026971	12/12/1990	CA	66.0	66		F	11/21/1990	Pt vaccinated with Influenza/TD developed intense pain & inability to move. MD prescribed antibiotics Cephalexin. Few days later still no improvement. MD removed blood clot & pt instantly regained ROM.				Y					Y	10/30/1990	10/30/1990	0		PUB	PUB	Apresoline		Hypertension	~ ()~~~In patient	CA9015	1						1	Pain; Thrombosis	FLU3~CONNAUGHT LABORATORIES~0F11203~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SCLAVO~110A1~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0026972	12/12/1990	CA	68.0	68		M	11/21/1990	Pt vaccinated with Influenza developed nausea, diarrhea, depression, upset stomach.				Y					Y	10/30/1990	11/06/1990	7	CBC - Normal	PUB	PUB			heart problem	In pt; Adverse event; 1975; Swine flu; 1 dose~ ()~~~In patient	CA9016	1						1	Depression; Diarrhoea; Dyspepsia; Nausea	FLU3~CONNAUGHT LABORATORIES~0F11203~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0026974	12/12/1990		15.0			F		Pt vaccinated with FLUOGEN; 17 days later developed synovitis/arthritis in wrist and ankle.									U	11/01/1990	11/17/1990	16		UNK	UNK	Valium, Tranxene			~ ()~~~In patient		1						1	Arthritis; Synovitis	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0026981	12/13/1990	NC	63.0	63		F	11/29/1990	Pt vaccinated with Pneumococcal 23/Influenza developed aching over body in PM; temp 101+ lasting 1&1/2 days; arm extremely sore x 3 days. At end of 2nd day, developed rash over upper arm which lasted 3 days.									Y	11/13/1990	11/13/1990	0		PUB	PUB				~ ()~~~In patient	NC90003	1						1	Pain; Pyrexia; Rash	FLU3~PARKE-DAVIS~02480P~2~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~0460S~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0026985	12/13/1990	CA	78.0	78		F	12/08/1990	Pt vacc'd w/FLU experienced flashing lights in both eyes for 15 min. When eyes cleared, sneezed several times & soft palate became tender, itchy & edematous. Subsided to mild sore throat & flu like sx, w/ fullness in head lasting longest.									Y	10/24/1990	10/28/1990	4		PVT	PVT	Thyroid		Seasonal hayfever	~ ()~~~In patient		1						1	Hallucination; Headache; Influenza; Oedema; Pharyngitis; Pruritus; Rhinitis; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0026996	12/14/1990	MS	67.0	67		F	11/21/1990	Pt received Influenza/Pneumococcal vaccine; developed severe headache, but no fever or other symptoms, that lasted for several hrs. Headache reoccurred 11-17-90 and hasn't been relieved.				Y					U	11/02/1990	11/02/1990	0	CAT Scan	PUB	PUB				~ ()~~~In patient	MS903	1						1	Headache	FLU3~PARKE-DAVIS~01770P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~281905~UNK~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0027057	12/17/1990	OR	21.0	21		M	12/11/1990	Pt vaccinated with FLU/TYPHOID developed nausea, vomiting, diarrhea, temp 103, WBC decreased, hypertension, chills, liver function test elevated.				Y	Y				Y	12/01/1990	12/01/1990	0	1DEC WBC-700, 21 POLYS, 25 SATS, 49L, EEOS. Bili 5.96, SGOT 103 SGPT 132 GGT 84, 2DEC WBC 1500-61P, 34ST, 3L platelets 87,000. Hepatitis panel - all negative except HB's AB (Had Hepatitis vaccine 2/89- 9/89	MIL	MIL	Indomethacin (PRN)			~ ()~~~In patient		1						1	Chills; Diarrhoea; Hepatic function abnormal; Hypotension; Leukopenia; Nausea; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~OJ11031~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~PFIZER\WYETH~4898237~3~IM A~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0027063	12/17/1990	OH	27.0	27		M	12/12/1990	c/o lt upper arm soreness since vax given on 5Nov90, no visible or palpable rxn noted, treatment was to apply heat & follow up /w family md if symptoms persist									U	11/05/1990				OTH	OTH				~ ()~~~In patient		1						1	Injection site pain	FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0027073	12/17/1990	WA	64.0	64		M	11/27/1990	Pt vaccinated with INFLUENZA became ill one day after flu shot, headache severe/constant x 1 wk, significant neck discomfort, denies fever, chill, abdominal pain or seizures, denies trauma. Photophobia, final dx probable viral syndrome.					Y	4			Y	11/19/1990	11/20/1990	1	CT SCAN & LUMBAR PUNCTURE NEGATIVE.	OTH	PUB	Coumadin, Digoxin		MITRAL valve replacement; 1987 rt nephrectomy for CA osteoarthritis of spine & knee; diabetes mellitus 1987; hepatomegaly - fatty infiltration; 1986 diverticulosis, 1987 cholecystectomy.	~ ()~~~In patient	WA90496	1						1	Headache; Influenza; Neck pain; Photophobia	FLU3~CONNAUGHT LABORATORIES~OJ11163~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0027077	12/17/1990	OK	57.0	57		F	11/10/1990	local rxn				Y					Y	11/08/1990	11/09/1990	1		PUB	PUB	antibiotics			~ ()~~~In patient	OK902	1						1	Injection site reaction	FLU3~CONNAUGHT LABORATORIES~0F11227~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0027078	12/17/1990	OK	67.0	67		M	11/15/1990	felt hot, arthralgia									U	11/13/1990	11/13/1990	0		PUB	PUB			has only one kidney	~ ()~~~In patient	OK903	1						1	Arthralgia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0F11217~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~253978~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0027080	12/17/1990	OK	34.0	34		F	11/09/1990	T 104, local rxn, dizzie, light headedness									U	11/08/1990	11/08/1990	0		PUB	PUB				~ ()~~~In patient	OK905	1						1	Dizziness; Injection site reaction; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0F11227~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~291954~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0027081	12/17/1990	MI	62.0	62		M	11/26/1990	shoulder & chest lt side were itching, discovered area numb when trying to scratch area, c/o SOB, numbness, denies numbness in neck afebrile advised to contact physician to r/o cardiac problems				Y					N	11/19/1990	11/21/1990	2		PUB	PUB	Theophyllin, Nifedipine, Captopril		allergies to Penicillin, Naprosyn, ASA, Motrin	~ ()~~~In patient	MI9005	1						1	Dyspnoea; Paraesthesia; Pruritus	FLU3~CONNAUGHT LABORATORIES~0F11222~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0027093	12/17/1990	FL	64.0	64		F	11/21/1990	Pt vaccinated with Influenza developed headache, felt nauseated,temp rose to 101 oral. Felt very sick.									Y	11/16/1990	11/16/1990	0		PUB	PUB			lactose, demerol, morphine, Irritable bowel	~ ()~~~In patient	FL9001	1						1	Headache; Malaise; Nausea; Pyrexia	FLU3~PARKE-DAVIS~01570P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0027094	12/18/1990	OR	64.0	64		F	12/17/1990	Guillain Barre Synd onset of weakness on 29Nov90, had illness /w vomiting diarrhea, chills & fever /w onset of 19Nov90 & lasting about 2-3 days				Y	Y				N	10/25/1990	11/29/1990	35	Nerve conduction studies suggestive of atypical Guillain Barre, CSF protein normal on 30Nov & 2Dec	UNK	UNK	Prednisone?		allergy to Septra, Hypertension			1						1	Asthenia; Chills; Diarrhoea; Guillain-Barre syndrome; Pyrexia; Vomiting	FLUX~PFIZER\WYETH~4908191~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0027095	12/18/1990	OR	64.0	64		M	12/14/1990	Guillain Barre Synd-progressive quadriparesis onset of weakness on 10Dec90, had febrile illness 1 wk prior this /w nausea & diarrhea treated /w Augmentin for a lt lower lobe infiltrate on CXR				Y	Y				N	11/02/1990	12/10/1990	38	nerve conduction studies slowing /w evidence of conduction block, CSF protein normal	PUB	OTH	Ventolin, Synthroid, Mevacor	sick about 1 wk prior to onset of GBS	Hypothyroid, Asthma, Hyperlipidemia	~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome	FLUX~PFIZER\WYETH~4908208~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0027097	12/18/1990	AL	80.0	80		F	12/14/1990	Guillian Barre Synd, onset of myalgia about 2 wks /p vax, increased weakness of extremities, legs > arms & in legs prox? distal musculature. Hospitalized 11Dec90			Y	Y	Y				U	11/16/1990	11/29/1990	13	Nerve conduction studies consistent /w Guilliain Barre on 13Dec90	OTH	PVT	Calan, Niacin, Maxzide		hypertension, hypercholesterolemia	~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome; Myalgia	FLU3~PARKE-DAVIS~01870P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation	Influenza
0027099	12/18/1990	MS	77.0	77		M	12/13/1990	onset of low grade afternoon fever approx 3 days /p vax & still persist approx 6 wks later each afternoon									N	10/12/1990	10/15/1990	3	complete evaluation is ongoing per infectious disease specialist	PVT	PVT			?CA reportedly /w cure per clinic	~ ()~~~In patient		1						1	Pyrexia	FLU3~PARKE-DAVIS~02070D~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0027100	12/18/1990	ME	60.0	60		F	12/13/1990	Pt vaccinated with FLUOGEN developed aching arm & head x several hrs.									Y	11/13/1990	11/13/1990	0		PVT	PVT	Vaseretic		HTN	~ ()~~~In patient		1						1	Headache; Pain	FLU3~PARKE-DAVIS~02680P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0027112	12/18/1990	WI	38.0	38		F	11/09/1990	onset of chills, T 99, stomach upset, dizziness, vomiting & hot/cold flashes									Y	10/30/1990	11/02/1990	3		PUB	PUB				~ ()~~~In patient	WI90047	1						1	Chills; Dizziness; Nausea; Pyrexia; Vasodilatation; Vomiting	FLUX~PFIZER\WYETH~4908209~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0027122	12/19/1990	MD	69.0	69		M	11/01/1990	T 99.0, lt arm has arthritis, nausea, upset stomach /w much gas									Y	10/31/1990	11/01/1990	1		PUB	PUB				~ ()~~~In patient	MD90109	1						1	Arthritis; Flatulence; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0F11227~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0027124	12/19/1990	MD	71.0	71		M	11/23/1990	arthritis, arthralgia									Y	10/22/1990	11/17/1990	26		PUB	PUB				~ ()~~~In patient	MD90115	1						1	Arthralgia; Arthritis	FLUX~PFIZER\WYETH~4908209~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0027141	12/21/1990	OK	84.0			M		Pt vax /w Flushot, B/P was 124/76, that evening @ 6:00 felt nauseated, @ 11:00 pm body ached all over, next day felt fine. Tues eve/Wed morn - he died	Y	10/25/1990							N	10/22/1990	10/22/1990	0		UNK	UNK			rash /w penicillin	~ ()~~~In patient		1						1	Nausea; Pain	FLU3~LEDERLE LABORATORIES~287974~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Results in Death	Influenza
0027152	12/21/1990	IL				F	12/06/1990	Pt vaccinated with Fluzone developed possible GBS.					Y				U					UNK	UNK				~ ()~~~In patient	CO3728	1						1	Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0027159	12/26/1990	NC	69.0	69		F	12/17/1990	Pt vaccinated w/FLUZONE developed cold next day - upper respir then cough. Seen by MD; normal WBC & HGB, but had cough w/ yellow mucous. Chest x-ray negative. Treated for bacterial bronchitis; improved for 2 days.  Found dead 2 days later.	Y	12/12/1990							N	11/26/1990			WBC 6,200; HGB 17.4; x-ray negative	PVT	PUB	Phenylpropanolamine w/ Guaiafenisin (generic Entex LA)	ganglion wrist	Penicillin by hx	~ ()~~~In patient		1						1	Bronchitis; Cough; Influenza	FLU3~CONNAUGHT LABORATORIES~OF11208~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0027162	12/26/1990	IN	44.0	44		M	12/18/1990	Pt vaccinated developed acute encephalo-myelitis				Y	Y				U	11/20/1990	12/09/1990	19	Spinal Tap increased Lymphs, CT, MRI WNL	PVT	PVT				~ ()~~~In patient		1						1	Encephalitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0027168	12/26/1990	IL	27.0	27		F	12/17/1990	On 11/7/90, developed chills, nausea, 103 fever, achiness, lasted 24-36 hrs treated w/aspirin/rest. 11/12/90 severe allergic rxn, hives on arms, neck, back, legs, face & throat. ER gave adrenaline inject. Treated hives w/Benadryl.				Y					Y	10/24/1990	11/12/1990	19		PUB	UNK	Insulin 2x daily to manage diabetes		Diabetes, type 1	~ ()~~~In patient		1						1	Chills; Hypersensitivity; Nausea; Pain; Pyrexia; Urticaria	FLUX~PFIZER\WYETH~4908209~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0027174	12/26/1990	CO	20.0	20		F	12/11/1990	Pt vacc'd w/influenza.  Within 10 min., developed dizziness, nausea, & ears rang; assisted to supine position on floor. Felt better in 5 mins. BP 130/70, Pulse 84. No swelling. ER doctor said vasovagal reaction.				Y					Y	12/07/1990	12/07/1990	0		PUB	PUB				~ ()~~~In patient	CO901	1						1	Dizziness; Nausea; Tinnitus	FLU3~PARKE-DAVIS~02480P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0027178	12/26/1990	CA	53.0	53		M	12/18/1990	Pt vaccinated with Influenza onset peripheal hypesthesias, facial diplegia, dysphagia, leg weakness, resolved w/long course prednisone.					Y	6			Y	10/22/1990	10/27/1990	5	Increased ACE level; LP increased protein, MRI 0, compatible w/savcoid	MIL	PVT			lumbar disc disease	~ ()~~~In patient		1						1	Facial palsy; Hypoaesthesia; Myasthenic syndrome; Speech disorder	FLU3~CONNAUGHT LABORATORIES~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0027179	12/26/1990	IL	70.0			M	12/17/1990	Pt vaccinated with Influenza developed rt brachial plexopathy - primarily in distribution of axillary nerve.							Y		Y		10/12/1990		EMG's x2, CT & MRI of head	PVT	UNK		s/d recent CVA	diabetes, HTN	~ ()~~~In patient		1						1	Neuropathy	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0027180	12/26/1990	NY	68.0	68		F	12/20/1990	Pt vaccinated with Influenza and was asymptomatic at time of shot; 10 days later, developed pleuritis , then progressed to diffuse arthralgia with arthritis in rt wrist.									N	11/21/1990	11/29/1990	8	ESR 59; CBC WNL; Rheumatoid factor (+) 1:40; CH 50 <2%.	PVT	UNK				~ ()~~~In patient		1						1	Arthralgia; Arthritis; Pleural disorder	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0027196	12/26/1990	CA	62.0	61		F	12/04/1990	Pt vaccinated with FLU: developed lft sore arm 2 days following immun.; had nausea for 2 days follwing flu shot; intermittent sharp pains in lft temple began 11/30 kept patient awake and lasted until 12/3/90. Consulted w/ PMD  by telephone.									Y	11/29/1990	11/30/1990	1		PUB	PUB	Premarin, Thyroid, Septra, Micro-K, hydorchlorothiazide		Sensitivity to anti-inflamatories, hayfever, variable hypertension	~ ()~~~In patient	CA9020	1						1	Headache; Nausea; Pain	FLUX~PFIZER\WYETH~OF11203~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0027197	12/26/1990	CA	57.0	57		F	12/07/1990	Pt vaccinated with Pneumococcal/Flu experienced pain, then swelling at site.									U	12/06/1990	12/07/1990	1		PUB	PUB			smog, grass, trees, milk, chocolate, Iodine.	~ ()~~~In patient	CA9019	1						1	Injection site oedema; Pain	FLU3~CONNAUGHT LABORATORIES~OFF11203~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~285909~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0027202	12/27/1990	NY	49.0			M	12/21/1990	Guillain Barre Syndrome, chronic Inflammatory demyelinating polyneuropathy					Y				Y	09/27/1990	10/07/1990	10	Electophysiological studies	OTH	PVT				In pt, GBS, age 49, Vax-Flu, ?dose # in series~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0027204	12/27/1990	FL	58.0			M		Following vax 62 yo male c/o weakness & difficulty swallowing&talking came to ER-hospitalized for 8 days Developed quadriplegia & resp difficulty,15Nov resp arrest. preliminary DX was Guillian Barre Synd.Final DX: GBS & resp failure					Y					10/30/1990	11/01/1990	2		UNK	UNK				~ ()~~~In patient	900211201	1						1	Apnoea; Asthenia; Dysphagia; Dyspnoea; Guillain-Barre syndrome	FLU3~LEDERLE LABORATORIES~287973~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation	Influenza
0027217	12/27/1990	LA	65.0	65		F	11/19/1990	Leg became painful from 6 above ankle, up leg, radiating to back.				Y					N	11/02/1990	11/02/1990	0		PUB	PUB			arthritis	~ ()~~~In patient	LA90122	1						1	Pain	FLU3~CONNAUGHT LABORATORIES~0F11221~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0027218	12/27/1990	LA	89.0	89		F	12/06/1990	developed bad cough, no fever 5 days/p vax. Coughed up green sputum				Y					Y	11/01/1990	11/06/1990	5	13NOV90 Bacterial Pneumonia culture	OTH	PUB	Vasotec, Bethanacol, Doriden, Verapamil, KCl.		allergies to sulfa, hx of URI's	~ ()~~~In patient	LA90121	1						1	Cough; Productive cough	FLU3~CONNAUGHT LABORATORIES~0F11221~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0027220	12/27/1990	PA	46.0	46		F	12/14/1990	Inflamation @ site of injection 30 min /p inject.  Headache /p 1 hr of inject. Dry mouth, flushed, warm 1 hr /p inject.  14Dec90 still has headache				Y					U	12/12/1990	12/12/1990	0		PUB	PUB	Synthroid, Inderol		Hay fever, Hypothroidism, Migraine	~ ()~~~In patient	PA9013	1						1	Dry mouth; Headache; Injection site reaction; Vasodilatation	FLU3~LEDERLE LABORATORIES~4908201~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0027222	12/27/1990	AZ	73.0	73		F	12/20/1990	Stomatitis one day /p injection									Y	11/02/1990	11/03/1990	1		PVT	PVT	Lanoxin. Bufferin		TIA, Diverticulosis, Atrial Tachycardia	~ ()~~~In patient		1						1	Stomatitis	FLU3~PARKE-DAVIS~02380P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~289905~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0027754	12/27/1990	CO	60.0	60		F	12/17/1990	Inc numbness of rt leg began w/in hrs of inject & condition progressed by JUN90 to bilat myelopathy. numbness in rt leg progressed to involve hip, proceeded all the way to foot, assoc w/weakness of leg, irreg bowel & difficult urinating.					Y	41	Y		N	11/03/1989	11/03/1989	0	26DEC89 XR narrowing of the L5-S1 interspace w/2nd degree spondolisthesis.   CXR old fibrocalcific disease of both upper lobes.  CBC:  Hgb 14.9, Hct 44.5, Nl red cell indicies, Platelets 239,000.  Urine neg, FBS 78, BUN 19, Creat 1.1, Lyte	OTH	PUB	ASA, Multivitamin, Quinine Sulfate, Simethicone, & singlets.9Nov89 pneumonia vax given		Degenrative arthritis	~ ()~~~In patient		1						1	Dysuria; Gait disturbance; Meningitis; Myasthenic syndrome; Myelitis; Paraesthesia; Paralysis	FLU3~CONNAUGHT LABORATORIES~9J01139~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0027226	12/28/1990	CA	2.0			M	12/07/1990	seizure reported in pt receiving Fluogen necessary due to bronchial asthma & neurological problems & 82 hrs later had seizure, taken to ER, T 101, more seizures,				Y					Y	11/30/1990	12/04/1990	4		PVT	UNK			bronchial asthma, neurological problems	~ ()~~~In patient	904090015	1						1	Convulsion; Pyrexia	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0027227	12/28/1990	ME	63.0			F	12/18/1990	pericarditis reported in pt who received Fluogen 10 days earlier, pt diabetic, Hospitalized, recovered					Y				Y	11/01/1990	11/10/1990	9		OTH	UNK	Glipizide, Indomethacin			~ ()~~~In patient	904090016	1						1	Pericarditis	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0027228	12/28/1990	NY	73.0	73		M	12/22/1990	Pt vaccinated w/FLU. Developed loss of memory for 2-3 hrs; headache; tired-listless (3 wks post flu shot); tingling extremities; slight occasional palpitations; joint, back & head aches of short duration. No treatment. Still not 100%.				Y	Y	1			Y	11/27/1990	11/29/1990	2	All tests negative - Cat Scan - thyroid hormone; Spinal fluid	UNK	UNK						1						1	Amnesia; Arthralgia; Asthenia; Back pain; Headache; Malaise; Palpitations; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0J11019~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0027245	12/31/1990	WA	61.0	61		F	12/17/1990	Pt vaccinated with Influenza developed sore throat, runny nose, head cold, eyes blood shot, coughing, fever, headache & hoarse voice.									Y	12/11/1990	12/12/1990	1		PUB	PUB				~ ()~~~In patient	WA90498	1						1	Conjunctivitis; Cough; Dysphonia; Headache; Pharyngitis; Pyrexia	FLU3~PARKE-DAVIS~020590P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0027252	12/31/1990	WV	70.0	70		M	11/20/1990	Pt vaccinated w/Influenza 1 day after immunization pt c/o throat & aching all over.				Y					N	11/02/1990	11/03/1990	1		PUB	PUB	Indural, Lanoxin, Ascriptin		hx of cardiac problems	In pt; flu-like symptoms; 69yr old; FLU; 1 dose~ ()~~~In patient		1						1	Myalgia; Pharyngitis	FLU3~PARKE-DAVIS~02780P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0027275	01/02/1991	MN	82.0	82		M	12/26/1990	Pt vaccinated with FLUOGEN apparent cardiac arrest - no breath/pulse 8PM - CPR initiated - transported to hosp where he expired.	Y	11/26/1990							N	11/26/1990	11/26/1990	0		OTH	OTH	Ascriptin, Metamucil		No allergies, murmur, parkinson's dsiease, arthritis, early cataracts, excision sebaceous cyst of back, benign keratosis of face.	~ ()~~~In patient		1						1	Apnoea; Cardiac arrest	FLU3~PARKE-DAVIS~01870P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0027278	01/02/1991	ME	57.0	57		M	12/20/1990	Pt vaccinated with Pneumococcal/FLU ZONE developed malaise, vomited x 1, redness across site rt arm w/swelling. Improved by 12/26/90.									Y	12/19/1990	12/20/1990	1		PVT	PVT	Advil, Theolair	Emphysema no acute	emphysema/Rt shoulder injury/smoker	~ ()~~~In patient		1						1	Injection site oedema; Injection site reaction; Malaise; Vomiting	FLU3~CONNAUGHT LABORATORIES~0F11200~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~287907~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0027281	01/02/1991	FL	19.0	19		F	12/12/1990	Pt vaccinated with FLUOGEN passed out at school. Taken to private MD for evaluation.				Y					Y	11/29/1990	12/04/1990	5	EEG - 24 hrs halter monitor	PUB	PUB	Lanoxin		past hx of PVC; pulmonary hypertension Down's synd	~ ()~~~In patient	FL9003	1						1	Syncope	FLU3~PARKE-DAVIS~02580P~5~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0027290	01/04/1991	OH	71.0	71		F	12/05/1990	Pt vaccinated with FLU experienced vomiting (forceful); Diarrhea.					Y	4			Y	10/30/1990	11/15/1990	16	kidney infection	PUB	PUB	Capoten			In pt; aching; 70yrold; Flu vax;~ ()~~~In patient	OH9055	1						1	Diarrhoea; Vomiting	FLU3~CONNAUGHT LABORATORIES~0F11222~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0027291	01/04/1991	OH	68.0	68		M	11/17/1990	Pt vaccinated w/FLU developed sore throat & stiff neck. Dr told pt that he'd seen 5 other people who had got flu shots (seen same day as pt).				Y					Y	11/01/1990	11/01/1990	0		PUB	PVT	BP, diuretics, K+, & heart med	developed stiff neck at clinic.	Increased BP, Heart trouble, asthmatic Bronchitis.	~ ()~~~In patient	OH9056	1						1	Asthma; Bronchitis; Nuchal rigidity; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~0F11222~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0027292	01/04/1991	OH	79.0	79		M	11/16/1990	Pt vaccinated with Influenza wife stated that her husband is allergic to antihistamines. He took the RU-Tuss from about 9NOV90 t6rough 13NOV90 symptoms were; SOB, swelling around the eyes, blurred vision & difficulty urinating.									U	11/07/1990	11/09/1990	2		PUB	PUB	Ru-tuss		allergies to antihistamines	~ ()~~~In patient	OH9057	1						1	Amblyopia; Dyspnoea; Dysuria; Face oedema	FLU3~CONNAUGHT LABORATORIES~OF11222~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0027301	01/04/1991	LA	70.0	70		F	12/18/1990	Pt vac with Influenza developed pulling in legs & arms about 4 days after shot. Also experienced weakness & numbness in arms, hands, legs & feet 7 days after shot. Seen by neurologist - no nerve damage, thinks may be caused by flu shot.				Y					N	11/09/1990	11/13/1990	4		PUB	PUB	Procardia		Increased BP - Polyps of the colon	~ ()~~~In patient	LA90129	1						1	Hypertonia; Myasthenic syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0F11221~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0027302	01/04/1991	IL	66.0			F	12/06/1990	Pt vaccinated w/Influenza developed aggravation reaction. This involved exacerbation of her polymyalgia rheumatica. Admitted to hosp w/severe painful weakness in her proximal muscles. Given steroidal therapy approx six months later, weaned.					Y	4			U	10/27/1988	11/14/1988	18	chest x-ray - Normal, no malignancy; Breast Exam: no malignancy; Sed rate: 75 (NL = 0-20 MM/1HR.) Nomocytic Anemia (MCHC):11.5 gms	PUB	UNK		Polymyalgia Rehumatica	Polymyalgia Rheumatica	~ ()~~~In patient	890341001B	1						1	Myalgia; Myasthenic syndrome; Pain	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0027303	01/04/1991	FL	74.0			M	12/11/1990	Pt vaccinated with Influenza developed keratoacanthoma at the site of injection four wks after receiving influenza vaccine. Hospitalized and the lesion was surgically removed.					Y				Y					PVT	PVT				~ ()~~~In patient	890346008B	1						1	Neoplasm skin	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0027304	01/04/1991	FL	82.0			F		Pt vac w/FLUOGEN developed brain stem disorder, weakness of extremities & hypertension, bilat ptosis, difficulty speaking & swallowing. Admitted to Hosp BP 217/87, P 70min, R 20min, BS 225 mg/DL.  Botulism suspected. Tensilon test neg.					Y				U	10/30/1990	11/09/1990	10	Spinal Tap & Ct head Scan WNL; Tensilon test - Negative.  CSF = wnl, EMG - planned.	UNK	UNK	Catapres, Tambocor, Digoxin, ASA, Clonidine		A CVA & Myasthenia gravis have been ruled out.	~ ()~~~In patient	904090014	1						1	Asthenia; Brain stem syndrome; Dysphagia; Eyelid ptosis; Hyperglycaemia; Hypertension; Speech disorder	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0027315	01/07/1991	FL	65.0	65		M	12/14/1990	Pt vaccinated with FLUOGEN developed severe headache approx 15 hrs after injection. Numbness & drawing of rt side of face 3 days later. Bell's Palsy.				Y					Y	10/02/1990	10/02/1990	0		PUB	UNK				~ ()~~~In patient	FL9005	1						1	Facial palsy; Headache; Paraesthesia	FLU3~PARKE-DAVIS~02580P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0027316	01/07/1991	FL	69.0	69		F	12/14/1990	Pt vaccinated with FLUOGEN developed rash over trunk w/intense itching 13 hrs after injection. Felt very bad. Myalgia.				Y					Y	10/02/1990	10/02/1990	0		PUB	PUB				~ ()~~~In patient	FL9006	1						1	Malaise; Myalgia; Pruritus; Rash	FLU3~PARKE-DAVIS~02580P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0027317	01/07/1991	FL	42.0	42		F	12/14/1990	Pt vaccinated w/FLUOGEN developed joint pain, rash arms, tingling in arms, rt shoulder pain, joints of fingers swollen (no pain), neck sore, numbness of fingers, difficulty in moving wrist, narrowing of visual field, fever, headache.				Y					Y	10/03/1990	10/04/1990	1		PUB	PUB				~ ()~~~In patient	FL9007	1						1	Arthralgia; Headache; Neck pain; Osteoarthritis; Pain; Paraesthesia; Pyrexia; Visual field defect	FLU3~PARKE-DAVIS~02580P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0027318	01/07/1991	IL	38.0	38		M	12/19/1990	Pt vaccinated with INFLUENZA developed fever, myalgias, fatigue, pain in the rt arm which later migrated to lt arm. Paresthesias developed in rt hand & rt arm weakness. Symptoms have gradually improved has mild pain.									U	11/15/1990	11/22/1990	7	SGOT rose to 191 but fell to 36. SGPT rose to 433 but fell to 97 by 17DEC. Hepatitis C. Antibody positive.	PVT	PVT				~ ()~~~In patient		1						1	Alanine aminotransferase increased; Aspartate aminotransferase increased; Asthenia; Laboratory test abnormal; Myalgia; Pain; Paraesthesia; Pyrexia	FLUX~PFIZER\WYETH~4908194~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0027337	01/08/1991	CA	62.0	61		M	12/07/1990	Pt vaccinated with Pneumococcal/FLU noted heat at injection site- rt arm extending to elbow w/fluid accumulation at elbow, making elbow sagy looking. No other symptoms, pain, or irritation.									U	12/06/1990	12/07/1990	1		PUB	PUB			Bee's/Wasps, bad back	~ ()~~~In patient	CA9025	1						1	Injection site reaction; Osteoarthritis	FLU3~CONNAUGHT LABORATORIES~0F11203~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~285909~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0027338	01/08/1991	CA	77.0	77		F	11/30/1990	Pt vaccinated with Influenza developed abd cramps, runny nose, no fever, fell on floor, unable to get up for 2 hrs, fell again, couldnt move for 4 hrs, saw MD dx asthmatic bronchitis, rx to Flu vaccine, E. Coli in blood-poss bladder infect.					Y	8			Y	10/19/1990	10/20/1990	1		PUB	PUB	during hospitalization:  Theodur, Prednisone, Ventolin			~ ()~~~In patient	CA9026	1						1	Abdominal pain; Asthenia; Asthma; Myalgia; Rhinitis; Sepsis	FLU3~CONNAUGHT LABORATORIES~0F11203~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0027339	01/08/1991	AZ	76.0	76		F	12/27/1990	Pt vaccinated with Influenza c/o achiness & flu-like s/s first wk. Confirmed febrile - becomes febrile 3-4PM & as high as 102 by 6-7PM, nigh sweats, weakness, nausea.				Y					N	10/29/1990	10/30/1990	1	Blood/Urine Cultures	PVT	UNK			CHF	~ ()~~~In patient	AZ9003	1						1	Asthenia; Hyperhidrosis; Influenza; Nausea; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0F11208~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0027346	01/08/1991	MI	76.0	76		F	01/02/1991	Pt vaccinated with FLU developed persistent muscle aches, weakness at inject site. Lasting 2 months now - no other hx of injury of other arthritic/rheumatic symptoms.									N	11/09/1990	11/09/1990	0		PVT	PVT	Synthroid		hypothyroid	~ ()~~~In patient		1						1	Asthenia; Injection site reaction; Myalgia	FLU3~PARKE-DAVIS~02070P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0027347	01/08/1991	IL	69.0			M		Pt vaccinated w/FLUOGEN developed thrombocytopenia & petechiae, sore mouth, CBC & platelet count revealed a platelet count of 2000 per cubic mm. Diffuse petechial hemorrhages. MD feel prob unrelated to the FLUOGEN to do bone marrow analysis									U	11/06/1990	11/09/1990	3	Platelet CT on 9NOV90 - 2000 per cubic millimeter	UNK	UNK	Mantle radiation.		Stage I Hodgkin's receiving mantle irradiation.	~ ()~~~In patient	904090010	1						1	Petechiae; Stomatitis; Thrombocytopenia	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0027363	01/10/1991	GA	66.0	66		M	12/10/1990	Pt vaccinated with PNEUMOVAC/FLU developed chills & fever approx 5 hrs after inject - visited ER w/weakness & shaking all over E61 SMA 18, Chest x-ray, CBC & U/A all normal.				Y					Y	11/19/1990	11/19/1990	0		PUB	PUB			prostate problems - heart bypass	~ ()~~~In patient	GA9015	1						1	Asthenia; Chills; Pyrexia; Tremor	FLUX~PFIZER\WYETH~4908199~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~18565~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0027371	01/11/1991	MD	73.0			M	12/17/1990	Pt vaccinated with FLUOGEN developed generalized weakness & increased ataxia.  Recovered w/in 7 days.				Y					Y	10/17/1990	10/18/1990	1		PVT	UNK	Sinemet, Aldoril		pt w/known Cerebellar degeneration w/ataxia.	~ ()~~~In patient	904090017	1						1	Asthenia; Coordination abnormal	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0027374	01/11/1991	NH	65.0	64		F		Pt vaccinated with Influenza developed vertigo.									U	10/17/1990				UNK	UNK				~ ()~~~In patient		1						1	Vertigo	FLUX~PFIZER\WYETH~079502~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0027226	01/14/1991	CA	2.0	2	.1	M	01/08/1991	Pt vaccinated with Fluogen developed seizure occured 82 hrs after vaccine given, had fever 101(R).					Y	2			Y	11/30/1990	12/04/1990	4	Clear panel tox-screen - EEG - negative	PVT	UNK	Albuterol		Macrocephaly,  developmental delay, asthma	~ ()~~~In patient		1						2	Convulsion; Pyrexia	FLU3~PARKE-DAVIS~01970P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Hospitalisation	Influenza
0027386	01/14/1991	FL	76.0	76		M	01/02/1991	Approx 4 wks after imm. developed severe weakness lasting 3-4 wks; rash on chest and buttocks & fingers; inject site red with white eruptions. Did not see a MD.									N	11/07/1990	11/11/1990	4		PUB	PUB	Alopurinol		Gout	~ ()~~~In patient	FL9008	1						1	Asthenia; Rash	FLU3~PARKE-DAVIS~0190P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0027388	01/14/1991	GA	7.0	7		F	12/27/1990	Pt vaccinated with FLU developed fever 102, vomiting, sore throat, red, mattered eyes, runny nose, cough.				Y					Y	11/28/1990	12/06/1990	8	blood work, chest x-ray (MCCG)	PUB	PUB	Folic acid, Pencillin		Sickle Cell	~ ()~~~In patient	GA9018	1						1	Cough; Pharyngitis; Pyrexia; Rhinitis; Vomiting	FLU3~PARKE-DAVIS~02580P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0027391	01/14/1991	MO	65.0	65		F	12/18/1990	Developed backache & headache, 100.6, no appetite. Wife & son had aches-pains mostly bronchial.									Y	11/06/1990	11/28/1990	22		PUB	PUB	Syntroid for thyroid			~ ()~~~In patient	MO901	1						1	Anorexia; Back pain; Headache; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0F11222~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0027393	01/14/1991	MO	68.0	68		M	12/18/1990	3 wks after FLU vaccine, developed backache, diarrhea, chills, drank lots of fluid, temp 104.2, nausea, tired & sleepy. Four other members of family had flu-like symptoms at same time.									Y	11/06/1990	11/27/1990	21		PUB	PUB	arthritic medication		Stroke 89 - compressed disc in spine column area - arthritis	~ ()~~~In patient	MO902	1						1	Back pain; Chills; Diarrhoea; Nausea; Pyrexia; Somnolence	FLU3~CONNAUGHT LABORATORIES~0F11222~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0027399	01/14/1991	OK	30.0	30		F	01/08/1991	Pain, slight swelling & warmth at inject site next day. Nausea & generalized myalgia/arthralgia lasting a couple of days.				Y					Y	11/13/1990	11/14/1990	1		OTH	PUB				~ ()~~~In patient	OK906	1						1	Arthralgia; Injection site oedema; Injection site reaction; Myalgia; Nausea; Pain	FLU3~CONNAUGHT LABORATORIES~0F11221~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0027402	01/14/1991	OK	59.0	59		F	01/10/1991	Local reactions, felt hot.									Y	11/14/1990	11/14/1990	0		PUB	PUB				~ ()~~~In patient	OK909	1						1	Injection site reaction; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0F11227~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~291954~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0027404	01/14/1991	OK	66.0	66		F	01/10/1991	Local reaction.									Y	11/02/1990	11/02/1990	0		PUB	PUB				~ ()~~~In patient	OK9011	1						1	Injection site reaction	FLU3~CONNAUGHT LABORATORIES~0F11217~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~293978~3~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0027412	01/14/1991	WA	30.0	30		M	01/03/1991	Approx 40 min after immun developed cold sweats, blacked out upon arising; headache x 12 hrs; muscle ached, diarrhea, temp 97.0.									Y	12/31/1990	01/02/1991	2		PUB	PUB			hx asthma	~ ()~~~In patient	WA91503	1						1	Diarrhoea; Headache; Hyperhidrosis; Myalgia; Syncope	FLU3~CONNAUGHT LABORATORIES~0F11223~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0027430	01/14/1991	NC	70.0			F		Pt vaccinated with Influenza developed erythematous, warm, raised area localized to site of inject. Resolved w/o significant complications. Low grade fever associated w/event. Treated w/ PO Acetaminophen & Diphenhydramine,Triamcinolone crm									U	10/18/1990	10/18/1990	0		UNK	UNK	Doxepin, Fluoxetine, Hydroxyzine		Has received such vaccines previously without complications.	~ ()~~~In patient		1						1	Injection site reaction; Pyrexia; Injection site hypersensitivity; Pyrexia; Vasodilatation	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0027431	01/14/1991		54.0			F		Pt vaccinated with FLUZONE  4 hrs post vaccine developed continual cough, throat edema, bronchitis. Seen by LMD given Adrenlin & Ventolin inhaler. Sent to ER from MD & office and put on Prednisone pack for 2 day.				Y					U	10/29/1990	10/29/1990	0		UNK	UNK	Mevacor		h/o rt mastectomy APR89 PAP normal	~ ()~~~In patient		1						1	Bronchitis; Cough; Laryngeal oedema	FLU3~PARKE-DAVIS~02590P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0027433	01/15/1991	TN	79.0	79		M		Pt vaccinated with Pneumococcal developed swelling of entire lt upper extremity w/pain, tenderness, heat redness developed during first 24 hrs after vaccine; total duration 1 wk.				Y					Y	10/19/1990	10/20/1990	1		PVT	PVT	Theodur, Elavil, Ferrous sulfate; GIven Pneumococcal 9SEP82		COPD, lt brachial plexopathy since 1983 (mild atrophy lt hand)	~ ()~~~In patient		1						1	Oedema; Pain; Rash; Vasodilatation	FLU3~PARKE-DAVIS~01970P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~287907~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0027454	01/18/1991	CA	36.0	36		F	12/18/1990	Flu shot 06Dec. pt c/o sore throat 09Dec90.  On 10Dec90 c/o congestion in head, sneezing & hot & cold spells at night & pressure in sinus area. PMD visit throat culture -negative. Rx for sinus infection. Felt better.				Y					Y	12/06/1990	12/09/1990	3	Throat Culture - Negative - 17DEC90	PUB	PUB	Vitamins only		Epstein-Barr	~ ()~~~In patient	CA911	1						1	Chills; Pharyngitis; Rhinitis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0F11203~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0027465	01/18/1991	FL	30.0			M	01/07/1991	Pt vaccinated w/FLUOGEN developed seizures pt mentally retarded w/a hx of seizure disorder but none since 1966, had a seizure 3 days after receiving FLUOGEN. 7 seizures since then. Only med Zantac.									U	11/01/1990	11/01/1990	0		OTH	OTH	Zantac/Lopid		hx of seizure disorder	~ ()~~~In patient	914090001	1						1	Convulsion	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0027491	01/18/1991	OH	30.0	30		M	01/03/1991	12/20: rash on upper thighs, & hips & rt ear red w/boil?; 21DEC rash noted on upper arms; 24DEC rash scattered on body - fading - no c/o itching. Given Erythromycin.									Y	12/17/1990	12/20/1990	3	ASO Titer - 1:12 (400-600) (normal <200)	OTH	UNK	Theragram M	Rehab-Mult trauma - MVA 29JAN90	PCN-skin rash, Splenectomy (age 4); Hx tracheal fistula closed 31OCT90.	~ ()~~~In patient		1						1	Rash	FLU3~PARKE-DAVIS~06580P~1~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0026721	01/22/1991	IA	71.0	71		M	12/24/1990	Started having funny feelings in both lower extrem this AM. Clumsy w/both legs-feel numb & tingly & don't work well. Poor coordination & difficulty rising, standing & sitting. Same in hands & forearms. PERL, BP180/100. Decreased reflexes.	Y			Y	Y	5			U	10/24/1990	11/02/1990	9	Referred to McKennon Hosp for Neurology Eval	PVT	PVT				~ ()~~~In patient	8903510021	1						3	Coordination abnormal; Gait disturbance; Guillain-Barre syndrome; Hypertension; Hypokinesia; Hyporeflexia; Paraesthesia	FLUX~PFIZER\WYETH~1908181~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Results in Death	Influenza
0027502	01/22/1991	PA	70.0	70		F	01/11/1991	acute supparative parotitis, lt side headache, earache, parotid swelling									U	01/04/1991	01/04/1991	0		PVT	PVT			Sjgrens syndrome	~ ()~~~In patient	PA916	1						1	Ear pain; Headache; Parotid gland enlargement; Sialoadenitis	FLU3~CONNAUGHT LABORATORIES~0F11221~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0027512	01/22/1991	CO	41.0	41		F	01/15/1991	throat swelled, hoarse, chest pain.				Y					Y	11/21/1990	11/22/1990	1		PVT	UNK				~ ()~~~In patient		1						1	Chest pain; Dysphonia; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~0F11227~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0027519	01/22/1991	TX	54.0	53		F	01/15/1991	flat rash, face rt neck & arm swelling rt arm.									Y	11/29/1990	11/30/1990	1		PVT	PVT				~ ()~~~In patient		1						1	Face oedema; Oedema; Rash	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0027522	01/22/1991	CO	29.0	29		F	01/15/1991	episode of coughing, sl. dysnea.									Y	11/12/1990	11/13/1990	1		PVT	UNK				~ ()~~~In patient		1						1	Cough; Dyspnoea	FLU3~CONNAUGHT LABORATORIES~0F11227~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0027523	01/22/1991		58.0	58		F	01/16/1991	Pt vaccinated with Fluzone developed lt Bell's palsy day after immunization & lasted  - 30D.									Y	10/16/1990	10/17/1990	1		PVT	UNK		AODM; Cirrhosis, Hemachromatosis		~ ()~~~In patient		1						1	Facial palsy	FLUX~UNKNOWN MANUFACTURER~0F11211~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0027529	01/24/1991	NH	78.0	78		F	01/18/1991	Hospitalized 7NOV90 w/dx of CHF. In & out hosp over next few wks. Released again on 7DEC90 but readmitted 9DEC90 & died CHF. Not able to provide any other symptoms.	Y	12/10/1990							N	11/06/1990	11/07/1990	1		UNK	UNK				~ ()~~~In patient	CO3759	1						1	Right ventricular failure	FLU3~CONNAUGHT LABORATORIES~0F11226~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0027543	01/25/1991	GA	85.0	84		M	11/21/1990	Pt vaccinated w/FLU developed difficulty walking out to the car, BP & Pulse normal. Felt clammy & blood sugar was 21. Also difficulty getting 1/2 cup coke swallowed was shaking & moaning,took to Hosp treated & observed in ER,admit for 1 day					Y	1			Y	11/19/1990	11/19/1990	0	Blood Sugar Test - 21	PUB	PUB	Procardia, Micronase, Ativan		Diabetes	~ ()~~~In patient	GA9025	1						1	Asthenia; Gait disturbance; Hyperhidrosis; Hypoglycaemia; Tremor	FLU3~PARKE-DAVIS~06580P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0027560	01/25/1991	OR	52.0			F		Wheezing & tightness in throat. Took Benedryl & symptoms were relieved.									U	10/19/1990	10/19/1990	0		UNK	UNK				~ ()~~~In patient		1						1	Asthma	FLU3~PARKE-DAVIS~01970P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0027634	01/29/1991	GA	31.0	31		M	01/09/1991	Consumer's husband, an army inductee was administered influenza virus vaccine (MFR unknown) during winter 1972-1973. Within 1 mo, pt condition dx as GBS. Hospitalized for 6 months. Pt currently under care of neurologist.					Y	180			U	02/01/1973	03/01/1973	28		MIL	OTH				~ ()~~~In patient	910006401	1						1	Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0027639	01/29/1991	TN				F	12/26/1990	4-5 hrs after receiving Influenza vaccine, pt experienced respiratory distress & fever of 105. Hospitalized for 3 days.					Y	3			U					OTH	OTH			Bronchiectasis	~ ()~~~In patient	910003501	1						1	Dyspnoea; Pyrexia	FLU3~LEDERLE LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation	Influenza
0027719	02/04/1991	PA	49.0	49		F	01/29/1991	Swelling at inject site lasted 5 days involved lymph nodes left arm.									Y	12/20/1990	12/21/1990	1		PUB	PUB				~ ()~~~In patient	PA9121	1						1	Injection site oedema; Lymphadenopathy	FLU3~CONNAUGHT LABORATORIES~0F11221~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0027738	02/04/1991	TX	74.0	74		M		Gums swollen, upper lip tender & puffy & dry, causing me to constantly wet lip w/tongue same condition w/lower lip, very annoying especially at night.									N	11/10/1988				PUB	PUB				~ ()~~~In patient		1						1	Dry mouth; Face oedema	FLUX~UNKNOWN MANUFACTURER~8F91126~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0027741	02/05/1991	CA	76.0	76		F	01/04/1991	Onset 24NOV profuse coryza. MD dx'd sinus infection; tx'd w/Seldane q 12 hrs x 7 days & TCN x 7 days.				Y					Y	11/19/1990	11/24/1990	5	PE only	PUB	PUB				~ ()~~~In patient	CA917	1						1	Rhinitis	FLU3~CONNAUGHT LABORATORIES~0F11203~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0027742	02/05/1991	CA	70.0	70		M	01/04/1991	Slight fever - 99.6 w/onset 30NOV chills x 7 day. Diarrhea; weakness; pain in chest. MD visit on 4DEC90. no dx made.				Y					Y	11/16/1990	11/30/1990	14		PUB	PUB				~ ()~~~In patient	CA918	1						1	Asthenia; Chest pain; Chills; Diarrhoea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0F11203~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0027743	02/05/1991	CA	77.0	77		F	01/04/1991	Developed injection site pain; no lump or discoloration. MD visit inconclusive. Advised warm, wet compresses.				Y					Y	11/06/1990	11/06/1990	0		PUB	PUB				~ ()~~~In patient	CA919	1						1	Injection site pain	FLU3~CONNAUGHT LABORATORIES~0F11203~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0027744	02/05/1991	CA	57.0	57		F	01/04/1991	Pt c/o weakness in hands & lack or coordination x 4-5 days. Rash on rt arm & behind neck. Swollen gland in neck. MD visit inconclusive. Recovered.				Y					Y	12/03/1990	12/04/1990	1		PUB	PUB		Denies	asthmatic; bronchitis	~ ()~~~In patient	CA9110	1						1	Coordination abnormal; Lymphadenopathy; Myasthenic syndrome; Rash	FLU3~CONNAUGHT LABORATORIES~0F11203~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0027751	02/05/1991	CA	35.0	35		M	11/07/1990	Injected 31OCT; 1NOV flu sx w/temp to 105-tx w/Advil; 2NOV -severe aches & pains, fever to 103; 5NOV fever gone, aches in arches of feet.									Y	10/31/1990	11/01/1990	1		PVT	PUB	AZT		ARC mild w/o sxs.	~ ()~~~In patient	CA9117	1						1	Influenza; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0F11203~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0027752	02/05/1991	FL	60.0	60		M	01/25/1991	Approx 7d, pain lower back, tingling hands.  Approx 14d, severe back pain & pain shooting up arms & legs & numbness in trunk & same area of pain. Hosp 5 wks-Therapy; Meds at home.unk when reflexs, nerves heal or numbness subsides.  + GBS.				Y	Y	35	Y		N	11/20/1990	11/27/1990	7		PUB	PVT				~ ()~~~In patient		1						1	Back pain; Guillain-Barre syndrome; Paraesthesia	FLU3~PARKE-DAVIS~02780P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0027764	02/05/1991	CA	79.0			F	01/29/1991	Developed chills, fever ache like sx & severe weakness lt leg could not walk or stand had polio on that leg as a teenager.									U	11/02/1990	11/02/1990	0		OTH	PVT				~ ()~~~In patient		1						1	Asthenia; Chills; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0027769	02/05/1991	CO	36.0			F		Severe, incapacitating headache w/mild moderate neck stiffness. No Kenng's or Brudzinski signs present.									U	10/14/1989	10/14/1989	0		UNK	UNK				~ ()~~~In patient		1						1	Headache; Nuchal rigidity	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0027816	02/08/1991	FL	62.0	62		M	01/28/1991	Fever, respiratory paralysis, etc. Admitted for about 2 wks. Under care of neurologists including automatic respirator.			Y	Y	Y	14	Y	Y	U	10/30/1990	11/12/1990	13	See hospital records; See treating physicians.	UNK	UNK			neck & back sprain (auto accident)			1						1	Apnoea; Muscle atrophy; Paralysis; Pyrexia	FLU3~LEDERLE LABORATORIES~287973~1~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0027819	02/08/1991	GA	46.0	46		F	11/26/1990	Itching & Welts.									Y	10/30/1990	10/31/1990	1		PVT	PVT				~ ()~~~In patient		1						1	Pruritus; Urticaria; Urticaria	FLUX~PFIZER\WYETH~4908212~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4908212~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0027820	02/08/1991	GA	48.0	48		F	11/07/1990	I ache all over headache.									U	11/02/1990	11/04/1990	2		PVT	PVT	Engerix-B listed as given within 4 wks of Flu but no date given.			~ ()~~~In patient		1						1	Headache; Pain	FLUX~PFIZER\WYETH~4908212~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0027821	02/08/1991	GA	30.0	30		F		W/in 12 hrs sore throat, hoarse voice non productive cough - progressed to HA, fatigue, malaise, muscle soreness. Sore throat has lasted 3 days is still present.									U	11/08/1990	11/09/1990	1		PVT	UNK				~ ()~~~In patient		1						1	Asthenia; Cough; Dysphonia; Headache; Malaise; Myalgia; Pharyngitis	FLUX~PFIZER\WYETH~4908212~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0027822	02/08/1991	GA	61.0	61		F	11/08/1990	Area @ inject site - hot, bruised, hard; - Systemic - flu-like sx re: feel bad, aching.									U	11/07/1990	11/07/1990	0		PVT	UNK				~ ()~~~In patient		1						1	Influenza; Injection site mass; Injection site reaction; Malaise; Pain	FLUX~PFIZER\WYETH~4908212~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0027823	02/08/1991	GA	31.0	31		F	11/08/1990	Large red circular area @ site of inject warm to touch & painful to touch.									U	11/07/1990	11/08/1990	1		PUB	UNK				~ ()~~~In patient		1						1	Injection site pain; Rash; Vasodilatation	FLUX~PFIZER\WYETH~4908212~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0027824	02/08/1991	GA	40.0	40		F	11/07/1990	Approx 24 past receiving flu vax noticed painful lump in rt axilla - same arm that injection given low grade temp noticed temp 99.2.									Y	11/06/1990	11/06/1990	0		UNK	UNK			yes - but not to vaccine per se	~ ()~~~In patient		1						1	Injection site mass; Injection site pain; Pyrexia	FLUX~PFIZER\WYETH~4908212~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0027825	02/08/1991	GA	28.0	28		F	11/07/1990	Developed Pain & swelling @ inject site; headache; sore throat; malaise; rhinitis.									Y	11/05/1990	11/05/1990	0		OTH	PVT				~ ()~~~In patient		1						1	Headache; Injection site pain; Injection site reaction; Malaise; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4908212~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0027826	02/08/1991	GA	54.0	54		F	11/07/1990	Nasal & head congestion & red itchy hard place @ inject site.									Y	11/05/1990	11/06/1990	1		PVT	UNK				~ ()~~~In patient		1						1	Injection site mass; Injection site reaction; Rhinitis	FLUX~PFIZER\WYETH~4908212~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0026059	02/12/1991	CA				M		Brachial Plexitis involving C5;									U	10/31/1989	11/07/1989	7	not available	UNK	UNK			not available	~ ()~~~In patient	CO3265	1						2	Neuropathy peripheral	FLU3~CONNAUGHT LABORATORIES~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~~UNK~~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0028077	02/12/1991	WI	72.0	72		M	02/07/1991	Possible GBS. While on vacation developed back pain, numbness & weakness in leg. Hospitalized. Currently undergoing physiotherapy.					Y				N	10/16/1990	10/31/1990	15		MIL	OTH	Diabanase			~ ()~~~In patient	CO3771	1						1	Asthenia; Back pain; Guillain-Barre syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0J11164~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0028529	02/12/1991	CO				U		Probable GBS;									U				not available	UNK	UNK			not available	~ ()~~~In patient	CO3727	1						1	Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0028556	02/12/1991	TX	29.0			F		Allergic rxn 4-6hrs post vax developed swelling & redness of hands & feet; Swelling & redness around mouth; Itching present; Inject site normal x/some soreness;									U	12/02/1989	12/02/1989	0	not available	UNK	UNK		not available	No hx of allergies;	~ ()~~~In patient	CO3234	1						1	Face oedema; Hypersensitivity; Injection site pain; Oedema; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~9F01201~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0028558	02/12/1991	IL				M		Fever up to 103F; Coughed up thick mucus which was blood tinged; Seen in ER; 23DEC89 temp down; %JAN90 cough still present; MD did not think cough related to inject;									U	12/19/1989	12/20/1989	1	not available	UNK	UNK			not available	~ ()~~~In patient	CO3279	1						1	Cough; Haemoptysis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~9F01230~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0028559	02/12/1991	PA				F		Gastroenteritis & fever 12 days post inject; Rx w/antibiotics; Had episode of flu-like sz; including fever, malaise, nausea & some headache;									U	10/06/1989	10/17/1989	11	not available	UNK	UNK			not available	~ ()~~~In patient	CO3284	1						1	Gastroenteritis; Headache; Influenza; Malaise; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0028560	02/12/1991	NY	36.0			U		Flu-like sx; fever, muscle ache, diarrhea & cough for 5 days duration; Seen in office;				Y					Y	01/08/1990	01/09/1990	1	not available	UNK	UNK			not available	~ ()~~~In patient	CO3309	1						1	Cough; Diarrhoea; Influenza; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~9F01230~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0028561	02/12/1991	IL	51.0			F		Photophobia & red, gritty & painful eyes post inject; Local rxn characterized by moderate pain & inc warmth;									U	11/04/1989	11/04/1989	0	not available	UNK	UNK			not available	~ ()~~~In patient	CO3395	1						1	Conjunctivitis; Eye pain; Injection site pain; Photophobia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0028562	02/12/1991	IL				U		Photophobia & red, gritty & painful eyes post injection;									U				not available	UNK	UNK			not available	~ ()~~~In patient	CO3396	1						1	Conjunctivitis; Eye pain; Photophobia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0028563	02/12/1991	IL	69.0			F		Photophobia & red, gritty & painful eyes post inject; Both eyes red & watery; Sensation of sand in the eyes;									U	11/03/1989	11/03/1989	0	not available	UNK	UNK			not available	~ ()~~~In patient	CO3397	1						1	Conjunctivitis; Lacrimal disorder; Photophobia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0028564	02/12/1991	CA				U		Developed myalgis & arthralgias soon p/receiving flu vax in fall of 1987; Seen by rheumatologist who felt she had a polymyalgia synd; Tx nonsteroidal antiinflammatory medication, local injects, physical therapy - (report inc);									U				not available	UNK	UNK			not available	~ ()~~~In patient	CO3604	1						1	Arthralgia; Arthropathy; Myalgia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0028565	02/12/1991	CA	68.0			F		severe itchy scalp in evening of inject; Also flu-like sx; Itchiness subsided but had pain & tenderness @ inject site; Rash developed on chest & back;									U	09/25/1990	09/25/1990	0	not available	UNK	UNK			not available	~ ()~~~In patient	CO3667	1						1	Influenza; Injection site pain; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~0F11202~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0028566	02/12/1991	CA	67.0			F		Flu-like sx; Was hospitalized;					Y				U				not available;	UNK	UNK			not available	~ ()~~~In patient	CO3693	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0F11217~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0028567	02/12/1991	CA	96.0			F		Flu-like symptoms									U				not available	UNK	UNK			not available		CO3694	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0F11217~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0028568	02/12/1991	CA	84.0			F		Flu-like sx;									U				not available	UNK	UNK			not available	~ ()~~~In patient	CO3695	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0F11217~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0028569	02/12/1991	NY	40.0			M		Febrile reaction to 101F;									Y				not available	UNK	UNK			not available	~ ()~~~In patient	CO3696	1						1	Pyrexia	FLU3~CONNAUGHT LABORATORIES~0F11216~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0028570	02/12/1991	PA	8.0			U		Hallucinations & night terrors in asthmatic;									U		11/21/1990			PVT	PVT			asthmatic	~ ()~~~In patient	CO3716	1						1	Abnormal dreams; Hallucination	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0028571	02/12/1991	OH				F		Prolonged intermittant fever, myalgias, fatiguing; Initial rash, especially inject arm; Pharyngitis/pleuritic discomfort;									U				not available	UNK	UNK			not available	~ ()~~~In patient	CO3721	1						1	Asthenia; Myalgia; Pain; Pharyngitis; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~0F11206~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0028572	02/12/1991	MT	52.0			F		Arm hot to touch, muscle stiffness & swelling; No tx to date; Had flu shot 5 yrs ago w/similar rxn; Pt stated she could not raise her arm laterally for over a year;									U		11/14/1990		not available	UNK	UNK			not available	~ ()~~~In patient	CO3723	1						1	Hypertonia; Oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0J11163~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0028573	02/12/1991	MD	46.0			F		Diffuse rash w/bullae 7 days post inject; Area around umbilicus showing early signs of necrosis;									U				not available	UNK	UNK			not available	~ ()~~~In patient	CO3724	1						1	Dermatitis bullous; Necrosis	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0028575	02/12/1991		71.0			M		Ezema allergicum; No known egg allergy; Previous vaccinations w/Fluzone 2x in'86, 1x in  '87, 1x in88;									U	09/18/1989	09/21/1989	3	not available	UNK	UNK	Guarem, Atenol, Digoxin, Euglucon N, Diformin retard		not available	~ ()~~~In patient	CO3375	1						1	Eczema	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0028576	02/12/1991		72.0			F		Erythematous area of 10cm @ inject site w/intact skin, burning, itchy & slightly swollen;									U	09/26/1989	09/28/1989	2	not available	UNK	UNK			NA	~ ()~~~In patient	CO3376	1						1	Injection site hypersensitivity; Injection site oedema; Injection site reaction; Pruritus	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0028577	02/12/1991		30.0			F		Diaphoresis, nausea, h/a upon awakening; Headache all day & p/dinner, diarrhea; pain @ inject site, unable to sleep on her arm;									U	10/16/1989	10/17/1989	1	NA	UNK	UNK			NA	~ ()~~~In patient	CO3679	1						1	Diarrhoea; Headache; Hyperhidrosis; Injection site pain; Nausea	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0028578	02/12/1991		10.0			M		Urticaria, mild, less tha 6 hrs duration;									U	10/17/1989	10/17/1989	0	NA	UNK	UNK			NA	~ ()~~~In patient	CO3680	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0028340	02/18/1991	NC	58.0	58		M	02/14/1991	20Nov90 pt developing back pain /w radiation down legs, weakness & some paralysis developed.  Was evaluated @ Hosp. DX of Guillian Barre made Dec90. Was allowed to return to full duty @ work 4Feb91				Y	Y				N	11/09/1990	11/20/1990	11	Information from hosp. has not yet been received.	OTH	PUB		none	none	~ ()~~~In patient		1						1	Asthenia; Back pain; Guillain-Barre syndrome; Paralysis	FLU3~PARKE-DAVIS~PD02680P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0028359	02/18/1991	NJ	47.0	47		F	02/15/1991	Numbness, tingling, face hands, feet. Paralysis, face. Weakness, upper & lower extremities					Y	20			N	10/31/1990	12/10/1990	40	EMG-polyneuropathy, EEG-normal	PVT	PVT	Prednisone, Lopressor, Lasix, Vasotec		Lupus, hypertension	~ ()~~~In patient		1						1	Asthenia; Facial palsy; Paraesthesia	FLUX~PFIZER\WYETH~4908205~2~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0028362	02/18/1991	CA	77.0	77		M	01/25/1991	8-10 days /p vax pt felt cold sxss, sneezing,sick all over,10 days /p that aching in lt arm &rt hip.2 wks later aching in lt hip &rt arm, ache cont's, difficult to raise arm &walk, Seen by MD TX:Cortisone & meds, Still has cold				Y					N	11/08/1990	11/18/1990	10	xray hip-showed arthritis	PUB	PUB	none	none	hx of prostate CA	none~ ()~~~In patient	CA9118	1						1	Arthralgia; Cough; Gait disturbance; Headache; Influenza; Pain; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0F11203~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~285909~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0028380	02/18/1991	MI	80.0	80		M	02/06/1991	Pt developed flu like respiratory symptoms nine days /p receiving Flu vax(1990-91 formula).Pt was admitted to acute care facility /w a respiratory infection, sepsis, & T. F/U info,recvd 25Jan91 resulted in reclassification as a 15 day rept					Y				U	10/01/1990	10/10/1990	9		PVT	PVT	none		pt has hx of cerebrovascular accident	~ ()~~~In patient	890291003B	1						1	Influenza; Pharyngitis; Pyrexia; Sepsis	FLUX~PFIZER\WYETH~4908209~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0028338	02/19/1991	TX	62.0			F		Itching, severely. Elbow pain, progressing to hip pain knee & instep.  Friday AM (10 days later) couldn't walk without assistance. Bad parasthesis in arms & leg (leg on 11/19)														UNK	UNK	Motrin tid, ASA daily, Metamucil		Penicillin allergy, degen joint disease, Rt side musculoskeletal chest pain, hx of migraine headaches	~ ()~~~In patient		1						1	Arthralgia; Gait disturbance; Paraesthesia; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0028403	02/22/1991	OH	60.0	60		M	02/14/1991	Numbness lt shoulder to finger tips- neck boil-like rt eye hot & like hot oil.				Y					N	11/29/1990	12/13/1990	14	Tendonitis	PUB	PUB	Metoprolol, nifidipine, isosorbib	NONE	heart condition, damaged getic nerve	NONE~ ()~~~In patient	OH91011	1						1	Conjunctivitis; Furuncle; Paraesthesia; Tenosynovitis	FLU3~CONNAUGHT LABORATORIES~0F11222~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0026837	02/25/1991	CO	79.0			F	02/19/1991	Systemic vasculitis resulting in GI bleed, diffuse cutaneous vasculitis /w ulceration of legs, CHF/pulonary edema, bradycardia, splenomegaly. Similar but milder react to previous dose.					Y				Y	11/01/1990	11/02/1990	1	+ RF 1:1280, ANA, CBC =	PVT	PVT	Synthroid			~ ()~~~In patient	CO9111	1						2	Bradycardia; Gastrointestinal haemorrhage; Pulmonary oedema; Right ventricular failure; Skin ulcer; Splenomegaly; Vasculitis	FLUX~PFIZER\WYETH~4908191~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0028416	02/25/1991	GA	76.0	76		M	01/28/1991	C/O of progressive weakness in arms & legs since vax 2Jan91, getting worse 28Jan91-resulting in MD visit, Hospitalized 1Feb91, Dx: Guillain Barre Disease					Y	7			N	01/02/1991	01/28/1991	26	4Feb19 lumbar spine CT-revealed mild bulging disc, Refused myelogram, CT Head 2Feb91-probably normal, question RE: Rt sylvania fissure	PUB	PUB	Cardezem	none	Coronary-artery disease; had CABG 1986-hx mild emphysema	none~ ()~~~In patient	GA9115	1						1	Asthenia; Guillain-Barre syndrome	FLUX~PFIZER\WYETH~4908209~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0028474	02/25/1991	WA	84.0	84		M	02/01/1991	Daughter called to rpt her father developed T 102 & angina pains, went to ER, MD admitted pt for test @ 300 pm, Tylenol given @ 600 pm, T nl & pt feeling OK, Put on 3 days of antibiotic as a precaution				Y	Y	1			Y	01/25/1991	01/31/1991	6	variety-slight elevation of WBC only thing found	PUB	PUB	Heart meds are routinely taken	none	heart problem-had open heart surgery 22 yrs ago	none~ ()~~~In patient	WA91509	1						1	Angina pectoris; Leukocytosis; Pyrexia	FLU3~LEDERLE LABORATORIES~289967~3~~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation	Influenza
0028476	02/26/1991	NC	28.0			M		Developed headache & flu-like sx for approx 2 days followed by slight numbness of hands & feet. Developed weakness that progressed to paralysis.					Y				U	09/27/1990	09/28/1990	1		UNK	UNK				~ ()~~~In patient		1						1	Asthenia; Headache; Influenza; Paraesthesia; Paralysis	FLUX~PFIZER\WYETH~4908193~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0028753	03/04/1991	CA	80.0	80		M	11/30/1990	Began URI w/fever 24NOV90, treated w/ Robitussin. Coughing, fever & depression  continued 26NOV90 rx Amoxicillin. Better & up walking 28NOV but @ 5PM was pale, dizzy, sweaty & had SOB.	Y	11/29/1990							N	11/23/1990	11/24/1990	1		OTH	PUB	Robitussin; Amoxicillin, 02, routine cardiac meds			~ ()~~~In patient	CA9130	1						1	Cough; Depression; Dizziness; Dyspnoea; Hyperhidrosis; Pallor; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0F11203~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0028832	03/06/1991	MD	67.0	67		M	11/08/1990	Local rxn rt deltoid/lt deltoid; pain in joints - especially back; headaches.				Y					N	10/25/1990	10/27/1990	2	BP 130/70	PUB	PUB				~ ()~~~In patient	MD91003	1						1	Arthralgia; Back pain; Headache; Injection site reaction	FLU3~PARKE-DAVIS~02580P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~289906~UNK~SC~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0028835	03/06/1991	MD	70.0	70		F	11/07/1990	local rxn lt deltoid, rash, T 103 F,B/P-145/89,fainted 26Oct,pain in joints,inflammation of joints,vomiting,dehydration,chills,coma or marked alt in level of consciousness,heart palpitations & rash,12Oct prior to vax bug on body(tick/bedbug				Y	Y	5			Y	10/02/1990	10/24/1990	22	B/P 145/89	PUB	PUB				~ ()~~~In patient	MD91006	1						1	Arthralgia; Arthritis; Chills; Coma; Dehydration; Injection site reaction; Palpitations; Pyrexia; Rash; Syncope; Vomiting	FLU3~PARKE-DAVIS~02580P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0028836	03/06/1991	MD	69.0	69		M	11/29/1990	Local rxn rt upper arm; headaches.									Y	11/28/1990	11/28/1990	0		PUB	PUB				~ ()~~~In patient	MD91007	1						1	Headache; Injection site reaction	FLUX~PFIZER\WYETH~4908209~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~283923~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0028837	03/06/1991	MD	50.0	50		M	11/09/1990	Local rxn rt upper arm extending below elbow; pain in joints; inflammation of joints.									U	11/07/1990	11/07/1990	0		PUB	PUB				~ ()~~~In patient	MD91008	1						1	Arthralgia; Arthritis; Injection site reaction	FLUX~PFIZER\WYETH~4908209~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~283923~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0028838	03/06/1991	MD	50.0	50		F	12/03/1990	Severely sore arm; unable to use arm; Began hurting several hrs p/inject; Instructed by MD since arm still very painful -Tylenol/warm compresses - appt to be seen.				Y					Y	11/27/1990	11/28/1990	1	NONE	PUB	PUB	NONE	Denied problems	Diabetes Mellitus, Osteoarthritis	~ ()~~~In patient	MD91010	1						1	Movement disorder; Pain	FLUX~PFIZER\WYETH~4908198~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0028839	03/06/1991	MD	51.0	51		F	12/03/1990	Generalized aching, congestion, hoarseness, headache developed 3rd day post immun. Did not take temp; Had congestion & Cough 3DEC90. Encouraged inc rest, good diet; vit/min supplement.				Y					Y	11/20/1990	11/23/1990	3	NONE	PUB	PUB		Denied		~ ()~~~In patient	MD91011	1						1	Cough; Dysphonia; Headache; Malaise; Rhinitis	FLUX~PFIZER\WYETH~4908198~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0028840	03/06/1991	MD	70.0	69		M	12/03/1990	Severe localized rxn @ rt deltoid inject site of 5-7 days duration. Did not consult MD. Treated w/Analgesic & warm compresses.									Y	11/27/1990	11/28/1990	1	NONE	PUB	PUB	NONE	DENIED	UNKNOWN	NONE~ ()~~~In patient	MD91012	1						1	Injection site reaction	FLUX~PFIZER\WYETH~4908198~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~285907~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0028843	03/06/1991	MD	60.0	60		M	01/14/1991	On 1DEC90 morning p/vax sore arms & shoulders states wife has to assist in dressing, unable to raise arms states no fever. Did not see MD, no lab work or xray.									N	11/30/1990	12/01/1990	1	NONE	PUB	PUB	NONE	NONE	NKA- Hx TB - 1960 Hospitalized-treated x 1 yr/advised not to take Cortizone	~ ()~~~In patient	MD91015	1						1	Arthralgia; Movement disorder; Pain	FLU3~PARKE-DAVIS~01970P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~291953~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0028874	03/07/1991	NV				F		Pt experienced nausea, a severe headache & a low grade fever within 24 hrs p/immun. Tx included Tylenol & Advil PRN.									U	09/04/1990	09/04/1990	0	NONE	UNK	UNK	NONE		No prior hx of reactions.	~ ()~~~In patient	900155801	1						1	Headache; Nausea; Pyrexia	FLU3~LEDERLE LABORATORIES~287977~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0028875	03/07/1991	NV				U		Pt experiened an injection site reaction described as a very sore arm w/swelling & erythema within 24 hrs p/immun. Also had fever & chills.									U	09/04/1990	09/04/1990	0	NONE	UNK	UNK	NONE	NONE	No prior hxl of reactions.	~ ()~~~In patient	900155802	1						1	Chills; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia	FLU3~LEDERLE LABORATORIES~287977~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0028876	03/07/1991	NV				U		Pt experienced an injection site reaction which included swelling @ site of injection & down the arm within 24 hrs p/immun.									U	09/04/1990	09/04/1990	0	NONE	UNK	UNK	NONE	NONE	No prior hx of reactions	NONE~ ()~~~In patient	900155803	1						1	Injection site oedema; Oedema	FLU3~LEDERLE LABORATORIES~287977~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0028877	03/07/1991	OR				F		Consumer reports that developed hives (neck to knees) after immunization.									U	10/05/1990	10/05/1990	0	NONE	UNK	UNK	NONE	NONE	consumer claims not to be allergic to eggs.	NONE~ ()~~~In patient	900175901	1						1	Urticaria	FLU3~LEDERLE LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0028878	03/07/1991	OH	74.0			M		Following immun last yr, 74 yo consumer became disoriented as to place. This remained for 3 days. Had rec'd the vax six yrs consecutively w/o a problem.									U				NONE	UNK	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient	900184501	1						1	Confusional state	FLU3~LEDERLE LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0029121	03/12/1991	OR	75.0	75		M	03/04/1991	Loss of sense of taste & smell.									N	10/01/1990			NONE	PVT	PVT	Amoxicillin; Phenergan w/cod	NONE	Hx of allergic rhinitis	~ ()~~~In patient		1						1	Ageusia; Parosmia	FLUX~PFIZER\WYETH~~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0029143	03/14/1991	MI	65.0			M	03/07/1991	Bilat paramedian vocal cord paralysis reported in pt receiving Fluogen. Had flu vax in Nov90 & became hoarse late Dec90. Seen mid Jan & found to have bilat paramedian vocal cord paralysis. As of 18Feb91, pt better. Dx=myasthenia gravis?	Y			Y	Y				N	11/25/1990	12/01/1990	6	considering myasthenia gravis as the etiology.CT SCAn &MRI of upper chest&neck initially-neg.F/U CT SCAN of upper chest:tumor involving SVC&both recurrent laryngeal nerves@thoracic inlet.	PVT	PVT				~ ()~~~In patient	914090008	1						1	Cyanosis; Dysphonia; Myasthenic syndrome; Neoplasm malignant; Vocal cord paralysis	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0029149	03/15/1991	MN	47.0	47		F	11/28/1990	Tightness in chest 10 min p/immun, lasted few min; nausea 90 min; congestion, cough 3 days; pt says still has nausea, cough, & congestion 4 1/2 wks later. No tx initiated @ either of 2 MD visits.				Y					N	10/26/1990	10/26/1990	0	MD did throat culture, CBC	PUB	PUB	Synthroid	headache, sinus problem	thyroid condition, previous histoplasmosis; no egg allergy	In pt; chills, nausea; 35yo; influenza; #1~ ()~~~In patient	MN90001	1						1	Chest pain; Cough; Nausea; Rhinitis	FLUX~PFIZER\WYETH~4908211~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0029150	03/15/1991	MN	87.0	87		F	11/20/1990	Admitted to hosp on 26OCT90 died on 26OCT90; MI w/cardiac arrest.	Y	10/26/1990		Y	Y	1			N	10/24/1990	10/26/1990	2		PUB	PUB				~ ()~~~In patient	MN90002	1						1	Cardiac failure; Myocardial infarction	FLU3~CONNAUGHT LABORATORIES~0F11200~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0029152	03/15/1991	MN	66.0	66		F		c/o elbow to shoulder area tender, warm, red but underneath, not where shot given discomfort noted w/movement. Neck & face red, warm, painful, itchy. Took Benadryl which offered relief. Neck, chin to ears still itchy & red.									N	11/15/1990	11/16/1990	1	NONE	PUB	PUB	NONE	NONE - felt fine	Radioisptope treatments to neck in 60's	NONE KNOWN~ ()~~~In patient	MN90004	1						1	Injection site hypersensitivity; Pain; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~4908188~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0029271	03/22/1991	MA	62.0	62		F		Pt developed progressive cough, DOE & low grade fever about 24 hrs p/vax x 2wks; Admitted to Hosp from 11DEC to about 20DEC w/bilateral pulmonary infiltrates hypoxemia & mild leukocytosis; No bacteriologic diagnosis was made;					Y	14			Y	11/08/1990	12/26/1990	48	11DEC90- WBC 16,700 w/no diff + PHS; ABG(RA)-7.48/PO2 36/PCO2 32; LFTS- NL	OTH	UNK			NONE	~ ()~~~In patient		1						1	Cough; Cyanosis; Dyspnoea; Hypoxia; Leukocytosis; Pyrexia; Respiratory disorder	FLU3~CONNAUGHT LABORATORIES~0F11221~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0029286	03/22/1991	OR	74.0	74		F	03/11/1991	Onset of pain & weakness rt arm & hand /win a few hrs of IM administration. stroke R/O by neurologist				Y						10/30/1990	10/30/1990	0		PUB	PVT			Arthritis, hypertension	~ ()~~~In patient		1						1	Myasthenic syndrome; Pain	FLUX~PFIZER\WYETH~4908208~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~287905~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0029302	03/25/1991	CA	61.0			F	02/19/1991	Rt arm extremely sore since pneumonia shot; States fever @ site when touched @ exactly where needle went in; Can't raise arm w/out excruciating pain; cannot hook bra; Sleeping w/heating pad; Has not seen MD for arm; Aches X 8 hrs/dy									U	11/01/1990	11/01/1990	0		PUB	UNK			Heart valve condition, lower back pathology, allergic Iodine	~ ()~~~In patient	CA9131	1						1	Injection site hypersensitivity; Movement disorder; Pain	FLU3~CONNAUGHT LABORATORIES~0F11203~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~285909~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0029349	03/25/1991	NC	30.0	30		F		Aides pupil diagnosed 13DEC90;								Y	N	10/13/1990	12/12/1990	60	0.12% Pilocarpine to affected eye to diagnose adies pupil	MIL	MIL		NONE	NA	NA~ ()~~~In patient		1						1	Pupillary disorder	FLU3~CONNAUGHT LABORATORIES~0J11164~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0029350	03/25/1991	CO	66.0	66		F	03/22/1991	Three days p/flu shot was given, pt came down w/what was consistent w/Herpes encephalitis; Autopsy also consistent with Herpes; Does not think encephalitis was related to flu shot;	Y	11/29/1990			Y	49			N	11/07/1990	11/10/1990	3	MRI & convalescent serum consistent	PVT	PVT	Dyazide	NONE	Hypertension, mild	~ ()~~~In patient		1						1	Encephalitis	FLU3~PARKE-DAVIS~025808~4~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0032939	03/28/1991	PA	43.0			M	11/27/1990	P/receiving Influenza vax, reporter devel erythema, induration, & swelling @ inject site 2 days later & impotence seven days later;									N	11/17/1990	11/19/1990	2		PVT	PVT	UNK	UNK	UNK	~ ()~~~In patient	890351006B	1						1	Erectile dysfunction; Injection site hypersensitivity; Injection site mass; Injection site oedema	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0029510	04/03/1991	NY	60.0			M	03/26/1991	Polymyalgia rheumatica reported in MD receiving FLUOGEN 1st shot 15DEC90; sx of URI, fevers to 101, chills w/rigors, myalgia, headache, fatigue, anorexia, non productive cough & dysesthesias of scalp; Atelectasis on CXR;					Y				Y	12/15/1990	12/16/1990	1	CBC, Sed RAT, Cold agglutinins, chemistry profile, CT scan of head & abdomin, Legionella titer - all WNL; CXR mild basilar; atelectasis during acute phase;	OTH	OTH	ASA	NONE	No egg allergy	NONE~ ()~~~In patient	914090005	1						1	Anorexia; Asthenia; Atelectasis; Chills; Cough; Headache; Myalgia; Paraesthesia; Pharyngitis; Pyrexia	FLU3~PARKE-DAVIS~~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0029811	04/08/1991	CA	73.0	73		F	03/08/1991	Neuropathy peripheral; pt developed flu-like sx w/in 24 hrs of receiving vax; third day, low grade fever developed which has persisted to date; Also aches, pain & weakness in her rt arm, & peripheral neuritis-dx branchial plexus neuropathy;	Y			Y	Y				N	10/19/1990	10/20/1990	1		PVT	PVT	UKN		pt has hx of malignant tumor of uterus, tx w/chemoterapy; Current MRIs show no recurrence of tumor or metastases;	~ ()~~~In patient	891078001B	1						1	Influenza; Myasthenic syndrome; Neoplasm malignant; Neuropathy; Neuropathy peripheral; Pain; Pyrexia	FLUX~PFIZER\WYETH~4908200~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0029819	04/09/1991	WA	57.0	56		F	11/13/1990	Pain, swelling, numbness immediately varied intensity 4-5hrs;									Y	11/09/1990	11/09/1990	0	NONE	PUB	PUB	NONE		NONE	NONE~ ()~~~In patient	WA91538	1						1	Oedema; Pain; Paraesthesia	FLUX~PFIZER\WYETH~4908208~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0029869	04/12/1991	OK	58.0	58		F	01/17/1991	Extreme swelling & pain approx 3-4 above lt elbow on outer aspect of upper arm; Unable to lift forearm above elbow level; Began shortly p/inject, & cont now 2 mo later; Seen by MD;				Y					N	11/02/1990	11/02/1990	0	NONE	PUB	PUB	NONE	nONE	NONE	NONE~ ()~~~In patient	OK9113	1						1	Oedema; Pain	FLU3~CONNAUGHT LABORATORIES~0F11227~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0029946	04/16/1991	NM	19.0			M		Brain stem disordr, cranial nerve palsies are rept'd in a pt rec'd Fluogen; Approx 1OCT90 rec'd vax 1 wk later developed cranial nerve palsies w/the concern of a poss demyelinating condition of the brain stem;					Y		Y		U	10/01/1990	10/01/1990	0	MRI & CT head scan - WNL; Sp Tap- no available	UNK	UNK			Pt had flu shot 1 yr ago w/out problems	~ ()~~~In patient	904090006	1						1	Brain stem syndrome; Neuropathy	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0029955	04/18/1991	CA	39.0	39		M	11/29/1990	Recvd injection 31Oct90- 15Nov90 numbness in lt arm-hand-went to ER-Adm for observation over night. DX virus-infection-still very tired. Had neurological evaluation.					Y	1			U	10/31/1990	11/15/1990	15	Neurological evaluation	PUB	PUB	Cardizem 30 mg tid, Presantine 50 mg tid	none	angio-plasty	~ ()~~~In patient	CA9139	1						1	Arthralgia; Asthenia; Chest pain; Cough; Hyperhidrosis; Hypertension; Influenza; Paraesthesia; Pharyngitis; Pyrexia	FLUX~PFIZER\WYETH~4908204~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0029956	04/18/1991	CA	59.0	59		F	11/26/1990	/Win 24 hrs of getting pneumonia & flu shot-area around the site of injection developed a rash /w an enlarging of the lymph gland under the arm. Lasted for about a wk. No TX.									Y	11/19/1990	11/20/1990	1	none	PUB	PUB		none	none	~ ()~~~In patient	CA9138	1						1	Injection site hypersensitivity; Lymphadenopathy	FLUX~PFIZER\WYETH~4908204~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~285909~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0029960	04/18/1991	MD	77.0	77		M	01/14/1991	Acute myocardial infarction assoc /w ischemic heart disease. Cardiogenic shock&congestive heart failure due to acute MI.Viral pneumonia assoc /w recent Inflenza vax complicated by 2ndary bacterial pneumonia leading to resp failure..see WORM	Y	10/09/1990							N	10/02/1990	10/09/1990	7	none	PUB	PUB		pneumonia, chronic bronchitis	heart disease, chronic renal failure /w ADCVD, nephrosclerotic vasc disease,HTN,pulmonary emphysema, peripheral vasc disease	~ ()~~~In patient	MD91019	1						1	Apnoea; Cardiac arrest; Pneumonia	FLU3~PARKE-DAVIS~PD02580P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0027819	04/22/1991	GA	46.0	46		F	04/19/1991	Severe hives;									Y	10/30/1990	10/31/1990	1		PVT	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient		1						2	Pruritus; Urticaria; Urticaria	FLUX~PFIZER\WYETH~4908212~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4908212~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0030075	04/22/1991	IL	67.0	67		M	01/11/1991	Pt experienced head congestion, arthralgia, swelling & tenderness of the lt axilla lymph nodes (5cm x 3cm) p/receiving Flu vax in lt deltoid; tx ASA 4 times day; Dx diffuse lymphocytic lymphoma based on tissue biopsy & bone marrow;			Y						Y	11/01/1990	11/17/1990	16		PVT	PVT	NONE	NONE	Pt has hx of kyphoscoliosis;	~ ()~~~In patient	891017005B	1						1	Arthralgia; Lymphadenopathy; Myalgia; Pain; Pseudo lymphoma; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0030202	04/29/1991	UT	41.0	41		M	11/30/1990	3 days p/inject pt experienced aching throughout lt arm w/same tingling & numbness of index & middle fingers; P/20NOV90 pain inc & is now severe; Turning neck seems to initiate pain;				Y					Y	10/30/1990	11/02/1990	3		PUB	PUB	Anti-inflammatory(ASA), APAP	NONE	Hypertension	NONE~ ()~~~In patient	UT9110	1						1	Pain; Paraesthesia	FLUX~PFIZER\WYETH~4908200~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0030242	04/29/1991	CO	47.0	47		F	04/05/1991	Pt experienced severe vomiting & cold sx approx 1 wk /p receiving vax on 9NOV90; Developed severe speaking difficulties 4mo later & was hospitalized; MRI revealed a lesion on the lt side of brain; dx w/demyelinating encephalopathy;				Y	Y	46		Y	Y	10/26/1990	11/06/1990	11	MRI-lesion on lt side of brain, biopsy-inconclusive results r/o a glimona & multiple sclerosis.	PVT	PVT	none	none		none~ ()~~~In patient	891099001B	1						1	Abscess; Central nervous system neoplasm; Cerebral infarction; Cerebrovascular accident; Multiple sclerosis; Neuropathy; Speech disorder; Thinking abnormal	FLUX~PFIZER\WYETH~4908181~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0030243	04/29/1991	CO	60.0	60		M	04/05/1991	Vomiting; pt, a MD, experienced severe vomiting p/receiving Influenza Virus Vax; Pt was hospitalized & tx IV fluids					Y				Y	10/25/1990	11/01/1990	7		PVT	PVT	none specified	none		~ ()~~~In patient	891099002B	1						1	Vomiting	FLUX~PFIZER\WYETH~4908181~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0030333	05/07/1991	MD	35.0	35		F	04/26/1991	Pruritus & urticaria p/FLUZONE 05.ml IM rxn 30 min p/inject; No hx of egg allergy; Tx DPH & topical sterioids;									Y	11/23/1990	11/23/1990	0	NONE	MIL	MIL	NONE	NONE	NONE	~ ()~~~In patient		1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~0J11031~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0030560	05/09/1991	NY	14.0			F		1day post vax entire arm was swollen, distal to the inject site, no redness, some soreness;									Y	12/04/1990	12/05/1990	1	NA	UNK	UNK	NA	NA	NA	NA~ ()~~~In patient	900216201	1						1	Oedema; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|TD~LEDERLE LABORATORIES~262905~UNK~IM~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0030433	05/13/1991	CT	73.0			F	03/15/1991	Experienced hearing loss, & several days after that began to experience both imbalance-room spins when she turns to the lt, & ocean wave type sounds in her lt ear;									U		11/12/1990			UNK	UNK				~ ()~~~In patient		1						1	Deafness; Gait disturbance; Tinnitus	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0030720	05/20/1991	FL	69.0			F	05/16/1991	Acute Resp infect, pulmonary infiltrates, hypoxemia reported in pt receiving FLUOGEN; Approx 15FEB91 hosp for acute resp infect accompanied by fever, myalgia, ha/ & sputum initially not purulent; d/c p/11days & was well 2.5 wks later;					Y	11			Y	10/01/1990	02/15/1991	137	Pos IgGtiter for Inf A, High Titer for IgG for inf B, pos Igm for infB mycoplasma neg	PVT	PVT				~ ()~~~In patient	914090047	1						1	Headache; Hypoxia; Infection; Lung disorder; Myalgia; Pyrexia; Respiratory disorder	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0030870	05/28/1991	NY				U		Elderly pt (70's) rec'd vax 12NOV90; 2 days later, experienced dizziness, retching & then vomited; Dizziness persisted for 2 days;									Y	11/12/1990	11/14/1990	2	NA	UNK	UNK	Tenormin, Diuretic, Ansaid			~ ()~~~In patient	900203501	1						1	Dizziness; Vomiting	FLU3~LEDERLE LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0030871	05/28/1991	MA				U		Approx 48hr p/immun, pt experienced a non-pyretic maculo papular rash over the entire body & an episode of diarrhea four hrs later; On exam had mild erythematous throat; No tx; Pt has sinus congestion 1 wk prior to immun;									U	11/13/1990	11/16/1990	3	NA	UNK	UNK			No hx of local or systemic rxn, hx of rash following ampicillin;	~ ()~~~In patient	900204101	1						1	Diarrhoea; Pharyngitis; Rash maculo-papular	FLU3~LEDERLE LABORATORIES~289965~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0031380	06/17/1991	CT	61.0	61		M	06/12/1991	Pt recvd vax 28SEP90. Pt developed progressive muscle weakness. Hospitalized 11OCT90 w/acute Guillian-Barre Synd. The pt required plasmapheresis & respirator support.			Y	Y	Y		Y		Y	09/28/1990	10/10/1990	12	spinal tap showing elevated protein	PVT	PVT	Cardizem	HTN, ASHD	none	~ ()~~~In patient		1						1	CSF test abnormal; Guillain-Barre syndrome; Myasthenic syndrome; Asthenia; CSF test abnormal; Dyspnoea; Guillain-Barre syndrome; Hypokinesia; Weight decreased	FLUX~PFIZER\WYETH~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4908183~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation	Influenza
0031424	06/18/1991	FL				U		Elevated temp & edema @ the inject site-lt deltoid;									U	10/11/1990	10/25/1990	14		UNK	UNK			Allergy to Zantac	~ ()~~~In patient		1						1	Injection site oedema; Pyrexia	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0031633	06/21/1991	PA	79.0	79		F	06/12/1991	Following vax in 1989 & 1990, w/in 1 wk the pt was hospitalized w/ pneumonia. Though the relationship was unclear, the pt was advised to avoid vax.					Y	5	Y		Y	11/12/1990	11/18/1990	6	chest xray	PVT	PVT		none	COPD, hypertension, s/p lobectomy for CA of lung	In pt no, In brother/sister no~ ()~~~In Sibling		1						1	Pneumonia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0031649	06/21/1991	IA	19.0	19		F	06/17/1991	Approx 18hrs post vax pt dev urticaria, blepharitis, & mild glossal edema;				Y					Y	11/05/1990	11/06/1990	1	NONE	OTH	PVT	NONE	NONE	PCN allergy	NONE~ ()~~~In patient		1						1	Blepharitis; Laryngeal oedema; Urticaria	FLUX~PFIZER\WYETH~4908207~1~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0031684	06/24/1991	IA	34.0	34		M	06/03/1991	Cervical spine cord infarction & subsequent death;	Y	12/10/1990							N	11/01/1990	11/18/1990	17	Autopsy report	OTH	OTH	No medications	NONE	NONE	~ ()~~~In patient	IA910018	1						1	Vascular occlusion	FLU3~CONNAUGHT LABORATORIES~0F11211~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0031716	06/24/1991	KY	29.0	29		F	06/19/1991	P/inject, arm got immediately numb, felt like throat was closing up & could not breathe; Pt was taken to ER; Dx Anaphylaxis;				Y					Y	10/31/1990	10/31/1990	0	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Anaphylactoid reaction; Dyspnoea; Hypoaesthesia	FLUX~PFIZER\WYETH~4908189~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0031733	06/24/1991	RI				U	12/30/1990	Drug eruption of the back poss egg rxn;									U					UNK	UNK				~ ()~~~In patient		1						1	Rash	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0031749	06/25/1991	NE				U		pt c/o night sweats, non-productive cough & lethargy states sx began shortly p/receiving vax; No fever; Seen by Md lethargy had abated but night sweats & cough cont;				Y					U		11/14/1990			UNK	UNK			Diabetes Mellitus, testicular cancer, cooronary artery disease;	~ ()~~~In patient		1						1	Cough; Hyperhidrosis; Somnolence	FLU3~CONNAUGHT LABORATORIES~0S11014~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0031993	07/01/1991	PA	69.0			F	06/19/1991	Pericarditis atrial fibrillation, thrombocytopenia, anemia reported in pt receiving Fluogen; Pt recd vax 27NOV89 & on 10DEC89 was admitted to hosp w/dx of viral pericarditis & new onset atrial fibrillation; dx paroysmal atrial fib & atelec					Y	24			Y	11/27/1989	12/10/1989	13	NONE	OTH	OTH				~ ()~~~In patient	914089002	1						1	Anaemia; Atelectasis; Atrial fibrillation; Pericarditis; Thrombocytopenia	FLU3~PARKE-DAVIS~01209P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0031994	07/01/1991					U	06/14/1991	Anaphylactoid rxn reported in pt receiving Fluogen pt devel chest tightness, dyspnea, chest pain, hoarseness & became cold & clammy; 3 other cases w/similar rxn used same box of syringes;									U				NONE	OTH	OTH			Pt had a hx of allergy pollen, house dust	~ ()~~~In patient	914090051	1						1	Anaphylactoid reaction; Chest pain; Dysphonia; Dyspnoea; Hyperhidrosis	FLU3~PARKE-DAVIS~02280P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0032279	07/08/1991	KS	56.0	56		F	11/29/1990	27NOV90 pt exp pain, swelling, chills, achy, a little dizzy & area was swollen w/lump lasted approx 2 days;									Y	11/27/1990	11/27/1990	0		PUB	PUB				~ ()~~~In patient	KS9120	1						1	Chills; Dizziness; Myalgia; Oedema; Pain; Skin nodule	FLUX~PFIZER\WYETH~4908193~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0033972	07/29/1991	NY	71.0			F		01Oct90 pt vax;  devel sore & swollen rt arm, dizziness, gen aching, nausea, chills, fever, & wheezing.									U	10/01/1990	10/01/1990	0	No relevant data	UNK	UNK	Unknown		No relevant hx	~ ()~~~In patient	WAES90100267	1						1	Asthma; Chills; Dizziness; Injection site oedema; Injection site pain; Myalgia; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0033973	07/29/1991	NY	72.0			M		01Oct90 pt vax;  exp gen achiness, & sore arm.  02Oct90 stayed in bed all day.									U	10/01/1990	10/01/1990	0	No relevant data	UNK	UNK	Unknown		No relevant hx	~ ()~~~In patient	WAES90100268	1						1	Malaise; Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0034031	07/29/1991	MD	70.0	70		M		Pt recvd vax on 18OCT90 & exp pain,swelling & erythma @ site of inject.On 23OCT90 pt devel a rash.Pt dx w/ herpes zoster.										10/18/1990	10/21/1990	3	No relevant data.	UNK	UNK			No relevant hx.	~ ()~~~In patient	WAES90101310	1						1	Herpes zoster; Pain; Rash	FLU3~CONNAUGHT LABORATORIES~0F11216~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1642R~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0034215	07/29/1991	WV	30.0			F		Pt recvd 1st dose of Pneumovax vax 01NOV90; On 02NOV90 exp pain & erythema in lt deltoid muscle; dx cellulitis; tx Keftab; MD felt exp related to vax;									U	11/01/1990	11/02/1990	1	No relevant data	UNK	UNK			No relevant hx	~ ()~~~In patient	WAES90110362	1						1	Cellulitis; Pain; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0487S~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0034219	07/29/1991	MO	21.0			F		Pt recvd vax on 23NOV90; immediately following vax devel 7 x 5 mm area of redness & induration; On 26NOV90 to MD ofc, exp fever, chills, h/a; On 28NOV90 5 x 4 area of redness & tenderness persisted; Given APAP; Pt recovered;				Y					Y	11/23/1990	11/23/1990	0	No relevant data	UNK	UNK	UNK		allergy sulfonamides;	~ ()~~~In patient	WAES90111174	1						1	Chills; Headache; Injection site hypersensitivity; Oedema; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0460S~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0033140	08/01/1991	FL	34.0			F		Lt arm swollen, site sore, warm to touch, neck itchy, h/a, swollen lips & eyes;									U	10/15/1990	10/16/1990	1	Med records no available from treating MD;	UNK	UNK				Pt had rxn to Recombivax & was previously hospitalized by MD~ ()~~~In patient		1						1	Face oedema; Headache; Injection site oedema; Injection site pain; Pruritus; Vasodilatation	FLU3~PARKE-DAVIS~02580P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0033219	08/05/1991	NY	66.0	65		M	06/20/1991	pt exp corneal graft reject of rt eye;				Y				Y	Y	09/21/1990	11/18/1990	58	exam by opthalmologist	PVT	PVT	Cardizam, tenorim, Isordil	NONE	Glaucoma rt eye since 1968; Cataract surgery lens implant; corneal graft rt eye 3JUL90	NONE~ ()~~~In patient		1						1	Corneal lesion	FLU3~LEDERLE LABORATORIES~287973~1~~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Disabling	Influenza
0033621	08/12/1991	ME	42.0	41		F	08/07/1991	Day p/vax got hot, burning, aching, goose egg, swelling @ vax site, felt nauseous x 3 hrs; sx improved by 48hrs p/vax;									Y	08/05/1991	08/06/1991	1		PVT	PVT	Theodur, Ventolin, intal	NONE	asthma	~ ()~~~In patient		1						1	Injection site oedema; Injection site pain; Nausea; Vasodilatation	FLUX~PFIZER\WYETH~4918136~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~2171S~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0043894	09/03/1991	NY	62.0	62		M	01/04/1991	Pt recvd flu vax & was admitted to hosp w/extremity weakness & numbness; approx 4-5 days prior to admission, pt had dorsal & epigastric pain assoc w/tingling in hands & feet;poss GBS; also areflexia; BP 190/100;					Y			Y	N	11/25/1988	12/10/1988	15	Spinal fluid analysis-inc spinal fluid protein, nl glucose & w/o leukocytes; Cholesterol 319; Triglycerides 276; EMG & Nerve conduction velocities showed mltifocal conduction abn;	OTH	OTH	Orudis Capsules	NONE	pt has known allergy to PCN; inc cholesterol in the past; pos for diabetes mellitus in mom & dad; father also had emphysema;	~ ()~~~In patient	B073089012	1						1	Asthenia; Back pain; CSF test abnormal; Electrocardiogram abnormal; Guillain-Barre syndrome; Hypertension; Hyporeflexia; Paraesthesia	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0034575	09/06/1991	FL				F	08/27/1991	Joint paralysis, arthritic-like sz, loss of memory & loss of equilibrium & accompanying dizziness & unspecified various muscular & skeletal pains reported by husband of pt receiving Fluogen; Vax recvd on 15OCT89;								Y	U	10/15/1989	10/15/1989	0	NONE	OTH	OTH	NONE	UNK	UNK	~ ()~~~In patient	914089003	1						1	Amnesia; Arthralgia; Arthritis; Coordination abnormal; Dizziness; Myalgia; Paralysis	FLU3~PARKE-DAVIS~01899P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Disabling	Influenza
0034998	09/26/1991	AZ				F	07/16/1990	P/receiving an inject of Influenza virus vax, pt devel transverse myelitis; Pt has improved;									U				NONE	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	890260011B	1						1	Myelitis	FLUX~PFIZER\WYETH~4896004~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0034999	09/26/1991	IA	42.0	42		F	02/06/1991	Since receiving vax on 24OCT89, pt exp fatigue, aches, & pains; Also noted sx w/viral infect on 27JUL89; in OCT89 devel mononucleosis; 26APR90 chronic fatigue synd, facial puffiness, backache, joint aches, chest tightness;				Y					N	10/24/1989	11/01/1989	8	OCT89 Monospot- + Mononucleosis; BUN-12.6, Cholesterol-189; HDL Cholesterol-36; Alk Phos-57; Glucose-92; SOdium-143; T4-5.4; Hgb-13.2; sed rate-7; Folic acid-16; ASO Titer---; ANA-1:80; Creatinine-1.0; triglycerides-121; SGOT-24;	PVT	PVT	NONE	Mononucleosis		~ ()~~~In patient	890344001B	1						1	Arthralgia; Asthenia; Back pain; Chest pain; Face oedema; Infection; Influenza; Laboratory test abnormal	FLUX~PFIZER\WYETH~4898059~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0035000	09/26/1991	MO				F	10/30/1990	p/receiving a dose of Influenza virus vax, pt noted atrophy @ the inject site for quite some time; Chronic inflammation of the muscle was also found @ the inject site;									U	10/01/1989				OTH	OTH	NONE			~ ()~~~In patient	890361005B	1						1	Injection site inflammation; Muscle atrophy	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0035001	09/26/1991	KS	62.0			F	07/09/1991	Pt exp erythema, edema & extreme pain @ inject site p/receiving Influenza virus vax; muscular pain also affected the trapezius muscles; not able to rotate head ten degrees in either direction secondary to pain & muscle spasm; Also fever;				Y					U	11/10/1989				OTH	OTH	Inderal, Xanax;		multiple allergies including PCN, Sulfa drugs, Keflex, & Ceclor; Also benign tremor; hx of arthritis of neck;	~ ()~~~In patient	BO73090002	1						1	Hypertonia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia; Pain; Pyrexia; Rash	FLUX~PFIZER\WYETH~4896006~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0035092	09/30/1991	MI	73.0	73		F	09/25/1991	6cm area of erythema & induration; rx Atarax;									U	09/24/1991	09/25/1991	1	NONE	PVT	PVT	NONE	Chronic bronchitis, emphysema	allergies codiene, ASA, Sulfa, PCN- no birth defects	~ ()~~~In patient		1						1	Rash	FLUX~PFIZER\WYETH~4918136~2~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0035111	09/30/1991	IN	15.0	15		F	11/12/1990	Approx 1wk post vax, pt devel flu-like illness, felt run down, h/a; Seen by MD felt sinus h/a; 11DEC88 admitted to Hosp; sx included muscle weakness, gait disturbances, facial weakness, rt shoulder pain, neck stiffness, sensory  loss, GBS;					Y	55		Y	U	10/31/1988	11/01/1988	1	Cytomegalovirus titer were found to be positive; 15DEC88 Gluscose-86, Protein-122; CMV titer >=160-pos; 12DEC88 ESR-50; 2JAN89 ESR 33; Motor Nerve conduction Velocities-peroneal motor nerve of 39 w/low amplitude response;	PVT	OTH	UNK	UNK	UNK	~ ()~~~In patient	890318005B	1						1	Gait disturbance; Guillain-Barre syndrome; Headache; Hyporeflexia; Influenza; Myalgia; Myasthenic syndrome; Paraesthesia	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0035112	09/30/1991	NJ				M	01/24/1991	Pt devel Guillain-Barre Synd subsequent to receiving Influenza Virus vax;									U	10/31/1988				OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	891033001B	1						1	Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0027430	10/15/1991	NC	70.0			F	12/28/1990	P/receiving Influenza vax, pt devel an erythematous, warm raised area (2.5 x 2.5 cm) @ inject site; This resolved w/o complications; Also low grade fever; tx meds;									Y	10/18/1990	10/18/1990	0		OTH	OTH	Doxepin, Fluoxetine, hydroxyzine	UNK	Pt has recvd Influenza vax previously w/o complications	~ ()~~~In patient	891012001B	1						2	Injection site reaction; Pyrexia; Injection site hypersensitivity; Pyrexia; Vasodilatation	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0032896	10/15/1991	PA	44.0			F	10/25/1990	Immediately following administration of Influenza vax, pt exp edema, pain, & erythema @ inject site; Area affected was approx 8 mm in diameter;									U				The Tubex of Influenza vax lot# 4908193 was examined & found satisfactory;	PVT	PVT	UNK	UNK	UNK	~ ()~~~In patient	890290005B	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~4908193~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032897	10/15/1991	PA	51.0	51		F	10/25/1990	3 hrs following vax, pt exp edema, pain, & erythema @ inject site; The area affected was approx 10 mm in diameter;									Y	09/17/1990	09/17/1990	0	Influenza vax lot# 4908193 was examined & found satisfactory;	PVT	PVT	UNK	NONE	NONE	~ ()~~~In patient	890290006B	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~4908193~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032898	10/15/1991	PA	41.0	41		F	10/25/1990	2 hrs folllowing administration of Influenza vax, pt exp edema, pain, & erythema @ inject site; Area affected was approx 14 mm in diameter;									Y	09/17/1990	09/17/1990	0	Influenza vax lot# 4908193 was examined & found satisfactory;	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	890290007B	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~4908193~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032899	10/15/1991	PA				U	08/29/1991	Following administration of Influenza vax, pt exp edema & erythema @ inject site; sx lasted for 72 hrs;									U				Influenza vax lot# 4908193 was examined & found satisfactory;	OTH	OTH	UNK	UNK	pt had received previous flu shots w/o adverse effect	~ ()~~~In patient	890290008B	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4908193~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032900	10/15/1991	PA				U	08/29/1991	Following adminisration of influenza vax, pt exp edema & erythema @ inject site; sx lasted over 72 hrs;									U				Influenza vax lot# 4908193 was examined & found satisfactory;	OTH	OTH	UNK	UNK		~ ()~~~In patient	890290009B	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4908193~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032901	10/15/1991	PA				U	08/29/1991	Following administration of Influenza vax, pt exp edema & erythema @ inject site; sx lasted for 72 hrs;									U				Influenva virus lot# 4908193 was examined & found satisfactory;	OTH	OTH	UNK	UNK	pt recvd previous flu shot w/o adverse effect	~ ()~~~In patient	890290010B	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4908193~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032902	10/15/1991	MI	54.0	54		M	10/17/1990	Pt, a resident of  a long-term care facility, devel flu-like sx & resp distress nine days p/receiving Influenza vax; This reaction necessitated a MD visit;				Y					Y	10/01/1990	10/10/1990	9		PVT	PVT	NONE		pt has multiple sclerosis & recurrent aspiration	~ ()~~~In patient	890291004B	1						1	Drug ineffective; Dyspnoea; Influenza	FLUX~PFIZER\WYETH~4908209~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0032903	10/15/1991	MI	83.0	83		M	10/17/1990	Pt, a resident in a long-term care facility, devel flu-like resp sxs 18 days p/being administered influenza vax; This necessitated a MD visit;				Y					Y	10/01/1990	10/19/1990	18		PVT	PVT	NONE		Pt has a sz disorder	~ ()~~~In patient	890291005B	1						1	Drug ineffective; Influenza; Respiratory disorder	FLUX~PFIZER\WYETH~4908209~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0032904	10/15/1991	MI	91.0			M	10/17/1990	Pt, a resident in a long-term care facility, devel flu-like resp sxs 11 days p/being administered influenza virus vax; This necessitated a MD visit;				Y					U	10/01/1990	10/12/1990	11		PVT	PVT	NONE		pt has congestive heart failure	~ ()~~~In patient	890291006B	1						1	Drug ineffective; Influenza; Respiratory disorder	FLUX~PFIZER\WYETH~4908209~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0032905	10/15/1991	MI				F	10/17/1990	Pt devel flu-like resp sx 11 days p/being administered Influenza vax; This necessitated a MD visit;				Y					Y	10/01/1990	10/12/1990	11		PVT	PVT	NONE			~ ()~~~In patient	890291007B	1						1	Drug ineffective; Influenza; Respiratory disorder	FLUX~PFIZER\WYETH~4908209~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0032906	10/15/1991	MI	77.0	76		F	10/17/1990	Pt, a resident of a long-term care facility, devel flu-like resp sx p/being administered influenza vax; This necessitated a MD visit;				Y					U	10/01/1990				PVT	PVT	NONE		Pt has hx of cerebrovascular accident & is post-colostomy revision;	~ ()~~~In patient	890291008B	1						1	Drug ineffective; Influenza; Respiratory disorder	FLUX~PFIZER\WYETH~4908209~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0032907	10/15/1991	IL	45.0			F	10/30/1990	3 days following immun w/Influenza virus, pt devel flu-like sx; symptoms included: a scratchy throat, nasal congestion, fatigue, watery eyes, & generalized aching lasting approx 7-8 hrs;									Y	10/20/1990	10/23/1990	3	Influenza vax lot# 4908196 was examined & found satisfactory;	PVT	PVT	NONE	NONE		~ ()~~~In patient	890303006B	1						1	Asthenia; Influenza; Lacrimal disorder; Myalgia; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4908196~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032908	10/15/1991	DE	80.0			F	10/10/1990	Following administration of Influenza vax, pt 80+ devel nausea & general feeling of illness;									U	10/08/1990	10/08/1990	0		PVT	PVT	Chloroquin	NONE		~ ()~~~In patient	890316003B	1						1	Malaise; Nausea	FLUX~PFIZER\WYETH~4908181~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032909	10/15/1991	DE	80.0			M	10/10/1990	Following administration of Influenza vax, pt 80+ yrs old devel nausea & general feeling of illness;									U	10/08/1990	10/08/1990	0		PVT	PVT	Chloroquin	NONE		~ ()~~~In patient	890316004B	1						1	Malaise; Nausea	FLUX~PFIZER\WYETH~4908181~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032910	10/15/1991	IN	64.0	64		F	12/11/1990	Following administration of Influenza vax, pt devel pain & swelling w/redness @ inject site; sx lasted for 2 days;									Y	09/14/1990	09/14/1990	0		PVT	PVT	NONE	NONE	NONE	UNK~ ()~~~In patient	890318001B	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~4908183~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032911	10/15/1991	IN	27.0	27		F	12/11/1990	Following administration of Influenza vax, pt devel pain @ inject site which persisted for one day;									Y	10/04/1990				PVT	PVT	NONE	NONE	NONE	UNK~ ()~~~In patient	890318002B	1						1	Injection site pain	FLUX~PFIZER\WYETH~4908183~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032912	10/15/1991	IN	21.0	21		F	12/11/1990	Following administration of Influenza vax, pt devel pain & swelling @ inject site down to elbow; This rxn persistd for 2 days;									Y	10/04/1990				PVT	PVT	NONE	NONE		~ ()~~~In patient	890318003B	1						1	Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~4908183~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032913	10/15/1991	IN	36.0	36		F	12/11/1990	Following administration of Influenza vax, pt devel pain & swelling @ inject site, which persisted for 3 days;									Y	10/03/1990				PVT	PVT	NONE	NONE	NONE	UNK~ ()~~~In patient	890318004B	1						1	Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~4908183~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032914	10/15/1991	ME				U	10/18/1990	Following administration of Influenza vax, pt devel erythema & edema @ inject site; Reporter though vax was injected into the triceps instead of deltoid area;									U	10/16/1990				PVT	PVT	UNK	UNK	UNK	~ ()~~~In patient	890318006B	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~IM~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032915	10/15/1991	ME				U	10/18/1990	Following administration of Influenza vax, pt erythema & edema @ inject site; REporter thought the vas was injected into the triceps instead of the deltoid area;									U	10/16/1990				PVT	PVT	UNK	UNK	UNK	~ ()~~~In patient	890318007B	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032916	10/15/1991	CA	56.0	56		M	10/23/1990	Approx 1 day p/receiving a dose of Influenva, pt devel severe pain in arm of inject radiating to shoulder, neck, & back; rxn was treated w/Vicodin & Naprosyn, sx resolved in 7 to 10 days;									Y	10/12/1990	10/13/1990	1		PVT	PVT	Elavil	NONE		~ ()~~~In patient	890325004B	1						1	Back pain; Neck pain; Pain	FLUX~PFIZER\WYETH~4809192~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032917	10/15/1991	WA				U	11/15/1990	Pt exp nausea, vomiting, diarrhea 1 wk p/Influenza vax; On f/u, reporter stated pt had gastrointestinal virus that was not related to vax;									U				NONE	PVT	PVT	UNK	UNK	UNK	~ ()~~~In patient	890332001B	1						1	Diarrhoea; Gastrointestinal disorder; Infection; Nausea; Vomiting	FLUX~PFIZER\WYETH~4908186~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032918	10/15/1991	WA				U	11/15/1990	Pt exp nausea, vomiting, & diarrhea 1 wk p/receiving Influenva vax; On f/u, reporter states pt had gastrointestinal virus that was not related to Influenza virus;									U				NONE	PVT	PVT	UNK	UNK	UNK	~ ()~~~In patient	890332002B	1						1	Diarrhoea; Gastrointestinal disorder; Infection; Nausea; Vomiting	FLUX~PFIZER\WYETH~4908186~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032919	10/15/1991	WA				U	11/15/1990	Pt exp nausea, vomiting, & diarrhea 1 wk p/receiving Influenza vax; On f/u, reporter stated pt had a gastrointestinal virus that was not related to the vax;									U				NONE	PVT	PVT	UNK	UNK	UNK	~ ()~~~In patient	890332003B	1						1	Diarrhoea; Gastrointestinal disorder; Infection; Nausea; Vomiting	FLUX~PFIZER\WYETH~4908186~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032920	10/15/1991	WA				U	11/15/1990	Pt exp nausea, vomiting, & diarrhea 1 wk p/receiving Influenza vax; On f/u, reporter stated pt had a gastrointestinal virus that was not related to vax;									U				NONE	PVT	PVT	UNK	UNK	UNK	~ ()~~~In patient	890332004B	1						1	Diarrhoea; Gastrointestinal disorder; Infection; Nausea; Vomiting	FLUX~PFIZER\WYETH~4908186~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032921	10/15/1991	WA				U	11/15/1990	Pt exp nausea, vomiting, & diarrhea 1 wk p/receiving Influenza vax; On f/u, reporter stated pt had a gastrointestinal virus that was not related to the vax;									U				NONE	PVT	PVT	UNK	UNK	UNK	~ ()~~~In patient	890332005B	1						1	Diarrhoea; Gastrointestinal disorder; Infection; Nausea; Vomiting	FLUX~PFIZER\WYETH~4908186~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032922	10/15/1991	WA				U	11/15/1990	Pt exp nausea, vomiting, & diarrhea 1 wk p/receiving Influenza vax; On f/u, reporter stated pt had a gastrointestinal virus that was not related to vax;									U				NONE	PVT	PVT	UNK	UNK	UNK	~ ()~~~In patient	890332006B	1						1	Diarrhoea; Gastrointestinal disorder; Infection; Nausea; Vomiting	FLUX~PFIZER\WYETH~4908186~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032923	10/15/1991	WA				U	11/15/1990	Pt exp nausea, vomiting, & diarrhea 1 wk p/receiving Influenza vax; On f/u, reporter stated pt had a gastrointestinal virus that was not related to vax;									U				NONE	PVT	PVT	UNK	UNK	UNK	~ ()~~~In patient	890332007B	1						1	Diarrhoea; Gastrointestinal disorder; Infection; Nausea; Vomiting	FLUX~PFIZER\WYETH~4908186~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032924	10/15/1991	WA				U	11/15/1990	Pt exp nausea, vomiting, & diarrhea 1 wk p/receiving vax; On f/u, reporter stated pt had a gastrointestinal virus that was not related to the vax;									U				NONE	PVT	PVT	UNK	UNK	UNK	~ ()~~~In patient	890332008B	1						1	Diarrhoea; Gastrointestinal disorder; Infection; Nausea; Vomiting	FLUX~PFIZER\WYETH~4908186~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032925	10/15/1991	WA				U	11/15/1990	Pt exp nausea, vomiting, & diarrhea 1 wk p/receiving Influenza virus; On f/u, reporter stated pt had a gastrointestinal virus that was not related to the Influenza vax;									U				NONE	PVT	PVT	UNK	UNK	UNK	~ ()~~~In patient	890332009B	1						1	Diarrhoea; Gastrointestinal disorder; Infection; Nausea; Vomiting	FLUX~PFIZER\WYETH~4908186~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032926	10/15/1991	WA				U	11/15/1990	Pt exp nausea, vomiting, & diarrhea 1 wk p/receiving Influenza vax; On f/u, reporter stated pt had a gastrointestinal virus that was not related to vax;									U				NONE	PVT	PVT	UNK	UNK	UNK	~ ()~~~In patient	890332010B	1						1	Diarrhoea; Gastrointestinal disorder; Infection; Nausea; Vomiting	FLUX~PFIZER\WYETH~4908186~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032927	10/15/1991	OH	44.0	44		F	11/15/1990	On 12NOV90, pt exp itching & swelling over entire body w/in minutes of receiving Influenza vax; Pt was given DPH; As of 15NOV90, sx have not subsided & the pt has severe swelling of the face & lips;									N	11/12/1990	11/12/1990	0	NONE	PVT	PVT	UNK	UNK	UNK	~ ()~~~In patient	890332012B	1						1	Face oedema; Oedema; Pruritus	FLUX~PFIZER\WYETH~4908194~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032928	10/15/1991	OH	87.0	87		F	12/04/1990	Pt devel vesicles of clear fluid over the trunk area, described as shingles approx 1 month p/receiving Influenza vax;									Y	10/24/1990	11/17/1990	24		OTH	OTH	NONE		Past med hx includes CVA, diabetes, hypertension, & duodenal ulcers;	~ ()~~~In patient	890339002B	1						1	Herpes zoster	FLUX~PFIZER\WYETH~~UNK~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032929	10/15/1991	OH	76.0	76		M	12/04/1990	Pt devel vesicles of clear fluid over the trunk area, described as shingles approx 1 mo p/receiivng Influenza vax;									Y	10/24/1990	11/29/1990	36		OTH	OTH	NONE		Pt has an allergy to TB serum; Past med hx includes Parkinson's disease, Alzheimer's disease, arteriosclerotic cardiovascular disease & CVA;	~ ()~~~In patient	890339003B	1						1	Herpes zoster	FLUX~PFIZER\WYETH~~UNK~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032930	10/15/1991	OH				U	12/04/1990	Pt devel shingles approx 30 days p/receiving Influenza vax;				Y					N					PVT	PVT	UNK	UNK	UNK	UNK~ ()~~~In patient	890339004B	1						1	Herpes zoster	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0032931	10/15/1991	OH				U	12/04/1990	Pt devel shingles approx 30 days p/receiving Influenza vax;									N					PVT	PVT	UNK	UNK	UNK	UNK~ ()~~~In patient	890339005B	1						1	Herpes zoster	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032932	10/15/1991	OH				U	12/04/1990	Pt devel shingles approx 30 days p/receiving Influenza vax;									N					PVT	PVT	UNK	UNK	UNK	UNK~ ()~~~In patient	890339006B	1						1	Herpes zoster	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032933	10/15/1991	OH				U	12/04/1990	Pt devel shingles approx 30 days p/receiving influenza vax;									N					PVT	PVT	UNK	UNK	UNK	UNK~ ()~~~In patient	890339007B	1						1	Herpes zoster	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032934	10/15/1991	MA	40.0	40		M	11/09/1990	Reporter devel a fever (103F), arthralgia, myalgia, chills, & shaking 3 days p/receiving Influenza vax; tx consisted of aspirin every four hrs & rest; rxn resolved in 24 hrs;									Y	11/05/1990	11/08/1990	3		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	890347015B	1						1	Arthralgia; Chills; Myalgia; Pyrexia; Tremor	FLUX~PFIZER\WYETH~4908210~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032935	10/15/1991	PA				M	11/09/1990	Pt exp a burning sensation & discomfort (pain) @ inject site immediately p/receiving Influenza vax; sx subsided 15-25 seconds p/inject & no other problems were noted;									Y	11/01/1990	11/01/1990	0		PVT	PVT	several Unspecified	NONE	Reporter poss recals pt having hypertension & diabetes;	NONE~ ()~~~In patient	890347016B	1						1	Injection site pain	FLUX~PFIZER\WYETH~4908201~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032936	10/15/1991	VA	33.0	33		F	11/14/1990	Pt exp a very sore arm, large swollen, hot to the touch, red circular area @ the inject site & a burning, aching (painful) shoulder p/receiving Inluenza vax;									Y	11/12/1990	11/12/1990	0	UNK	PVT	PVT	Premarin	NONE	pt has allergies to PCN, Pamelor, & Voltaren	~ ()~~~In patient	890351001B	1						1	Injection site hypersensitivity; Injection site oedema; Pain; Vasodilatation	FLUX~PFIZER\WYETH~4908186~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032937	10/15/1991	NY				M	11/21/1990	Pt devel severe viral pneumonia 12 days p/receiving Influenza vax; MD feels this ADE may not be related to the vax;									U				UNK	PVT	PVT	UNK	UNK	UNK	~ ()~~~In patient	890351003B	1						1	Pneumonia	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0032938	10/15/1991	PA	74.0	74		F	01/25/1991	Pt exp positional vertigo on the rt approx 12 hrs p/receiving Influenza vax; Pt vision blanked out for two seconds;				Y					N	11/15/1990	11/17/1990	2		PVT	PVT	ASA, Synthroid	NONE	pt has peptic ulcer disease & Graves disease;	~ ()~~~In patient	890351004B	1						1	Vertigo; Visual disturbance	FLUX~PFIZER\WYETH~4908913~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0033096	10/15/1991	GA	68.0	68		M	02/21/1991	Approx 3 to 4 wks p/receiving Influenza vax, pt devel weakness in quadriceps muscles, w/difficulty climbing stairs & rising from a sitting posiiton, & numbness of feet; dx acquired sensorimotor polyneuropathy, demyelinating type, re-GBS;				Y	Y				U	10/18/1990	11/12/1990	25	14DEC90 EMG-slight weakness 4.75/5 in the iliopsoas & hip extensors bilaterally; absence ofdeep tendon reflexes in upper & lower extremities; 14DEC90 Nerve conduction studies-prolonged peroneal conduction velocity; f-wave latencies;	OTH	PVT	NONE	NONE	Pt has chronic allergies to dust, grasses, & hx of severe allergy to horse serum discovered @ age 7;	Pt exp weakness & numbness @ 67 y/o w/Influenza;~ ()~~~In patient	890354002B	1						1	Asthenia; Guillain-Barre syndrome; Hyporeflexia; Paraesthesia	FLUX~PFIZER\WYETH~4908209~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0033097	10/15/1991	NM	32.0	32		M	01/28/1991	w/in five minutes of receiving a dose of Influenza vax, pt devel an anaphylactic rxn; Became light-headed, pale, unresponsive, cyanotic & began to convulse; tx Epi & regained consciousness immediately; Sent to ER where observed;				Y					Y	10/23/1990	10/23/1990	0		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	890360001B	1						1	Anaphylactoid reaction; Convulsion; Cyanosis; Dizziness; Pallor; Stupor	FLUX~PFIZER\WYETH~4908208~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0033098	10/15/1991	IL	34.0	34		M	01/18/1991	Pt devel Bell's Palsy w/in 2 days of receiving Influenza vax; sx included lt sided facial weakness & aching, & dull h/a; Pt was treated w/pred 2 days later; Pt had URI 1 wk prior to receiving the vax;									U	10/15/1990	10/16/1990	1		PVT	PVT	NONE	Cold & sniffles 1 wk a/vax	UNK	~ ()~~~In patient	890361001B	1						1	Facial palsy; Headache; Myalgia; Myasthenic syndrome	FLUX~PFIZER\WYETH~4908196~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0033099	10/15/1991	VA	35.0	35		M	10/30/1990	1 wk p/receiving a dose of Influenza vax, pt turned bright red color all over body; Reporter feel rxn may be due to niacin;									Y	10/17/1990	10/25/1990	8		PVT	PVT	Niacin, Vitamin B12, Garlic			~ ()~~~In patient	890361002B	1						1	Skin discolouration	FLUX~PFIZER\WYETH~4908187~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0033100	10/15/1991	VA	42.0	42		M	10/30/1990	P/receiving Influenza vax, pt devel sores in mouth & itchy, red hard raised somewhat painful skin eruptions on shoulders; The eruptions were the size of a fifty cent piece; @ time of vax pt had earache (lt ear); Seen by MD;				Y					Y	10/11/1990	10/13/1990	2	Staph screen-neg;	PVT	PVT	Motrin tab, Amphogel, Parafon, Deconamine	Earache (lt ear)	NONE	~ ()~~~In patient	890361003B	1						1	Mouth ulceration; Pruritus; Rash maculo-papular	FLUX~PFIZER\WYETH~4908187~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0033296	10/15/1991	ME	35.0	34		F	10/30/1990	P/receiving a dose of Influenza vax, pt exp numbness in arms & legs; MD reported subsequent events indicated the pts sx were clearly due to another illness & were not in any way related to administration of the vax;									U	10/16/1990	10/16/1990	0		OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	890361004B	1						1	Paraesthesia	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0033297	10/15/1991	IA	41.0	41		F	11/01/1990	Pt devel hives on the rt upper arm, lasting 4 days, several hrs p/receiving Influenza vax; In addition, pt exp severe h/a, sore throat, & fever, all persisting for 5 days; The day following inject nausea & vomiting occurred & persisted 3d;									Y	10/26/1990	10/26/1990	0		PUB	PUB	NONE	NONE	No known allergies	NONE~ ()~~~In patient	890361006B	1						1	Headache; Nausea; Pharyngitis; Pyrexia; Urticaria; Vomiting	FLUX~PFIZER\WYETH~4908184~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0033298	10/15/1991	WA	70.0			M	11/02/1990	P/receiving a dose of Influenva vax, pt exp chills & fever; 2 wks later devel pain in arm which radiated down the arm & still persists; Reporter was unable to provide any additional info;									N					PVT	PVT	UNK	UNK	UNK	~ ()~~~In patient	890361007B	1						1	Chills; Pain; Pyrexia	FLUX~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0033299	10/15/1991	AL	36.0	35		F	11/28/1990	Pt recvd Influenza vax in the lt deltoid on 26OCT90, & devel pain in rt flank area 19NOV90; This was followed by vesicular eruption on 22NOV90 & devel of shingles covering an area of approx 2 x 4 on rt flank area;									Y	10/26/1990	11/19/1990	24		PVT	PVT	NONE	NONE	pt recvd Influenza virus vax 1988 & 1989	~ ()~~~In patient	890361010B	1						1	Herpes zoster; Pain	FLUX~PFIZER\WYETH~4908202~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0033300	10/15/1991	ME				F	11/29/1990	Pt exp severe h/a, neck pain, & shoulder pain w/muscle spasms p/receiving Influenza vax; Pt was seen in Er 11NOV90 for h/a & muscle spasm in neck; Pt seen again 14 & 15NOV90; 19NOV90 w/tendinitis of lt deltoid; 26NOV90 w/h/a;				Y					N	10/30/1990	11/06/1990	7	CT Scan-normal	PUB	PUB	NONE			~ ()~~~In patient	891004002B	1						1	Headache; Hypertonia; Neck pain; Tenosynovitis	FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0033301	10/15/1991	TN				U	11/30/1990	P/receiving Influenza vax, pt devel severe erythema, induration, edema, & itching @ inject site; rxn area was 10-20 cm in size;									U					PVT	PVT	UNK			~ ()~~~In patient	891004007B	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pruritus	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0033302	10/15/1991	TN				U	11/30/1990	P/receiving influenza vax, pt devel severe erythema, induration, edema, & itching @ inject site, rxn area was 10-20 cm in size;									U					PVT	PVT	UNK			UNK~ ()~~~In patient	891004008B	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pruritus	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0033303	10/15/1991	TN				U	11/30/1990	P/receiving Influenza vax, pt devel severe erythema, induration, edema, & itching @ inject site; rx area was 10-20 cm in size;									U					PVT	PVT	UNK			UNK~ ()~~~In patient	891004009B	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pruritus	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0033304	10/15/1991	IA	65.0	65		F	12/17/1990	Pt devel sx of labyrinthitis p/receiving Influenza vax; Pt also recvd Pneumococcal vax on 10DEC90;				Y					Y	12/08/1990	12/11/1990	3		PVT	PVT	Verapamil	NONE	pt has hx of breast cancer (1974) w/no metastasis;	NONE~ ()~~~In patient	891008014B	1						1	Vestibular disorder	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0033306	10/15/1991	MI				F	12/20/1990	Pt devel a vasculitis synd 1 day p/receiving Influenza vax; sx included rash on both arms & a purple rash on both legs & swelling of ankles; p/progression over the 1st 48 to 60 hrs, rash slowly began to subside; pt seen by specialist;				Y					Y	12/03/1990	12/04/1990	1	ANA-neg;	PVT	OTH	Novolin 70/30 insulin		pt has diabetes;	~ ()~~~In patient	891012002B	1						1	Oedema; Rash; Vasculitis	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0033307	10/15/1991	CO	8.0	8		M	01/08/1991	Pt devel generalized achiness & tenderness & swelling in lt ax node w/in 24 hrs of receiving Influenza vax; ax node was described as walnut-sized; Pt seen on 28DEC90, node was much smaller & non-tender;				Y					Y	12/21/1990	12/22/1990	1		PVT	PVT	NONE	NONE	NONE	NA~ ()~~~In patient	891012003B	1						1	Lymphadenopathy; Myalgia; Oedema; Pain	FLUX~PFIZER\WYETH~4908205~1~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0033308	10/15/1991	CO	45.0	44		F	01/08/1991	Pt devel generalized achiness, h/a, lt subclavicular node swelling & tenderness p/receiving Influenza vax; Subclavicular node described as grape-sized; When pt seen 4JAN91, node was smaller & other sx resolved;				Y					Y	12/31/1990	01/01/1991	1		PVT	PVT	NONE	NONE		NA~ ()~~~In patient	891012004B	1						1	Headache; Lymphadenopathy; Myalgia; Pain	FLUX~PFIZER\WYETH~4908205~1~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0033309	10/15/1991	MN	35.0	35		F	01/02/1991	Pt devel pain in the hands (arthritis-like), ankles, & knees & muscle aches 2 to 3 days p/receiving Influenza vax; Pt was being treated s/ASA; Aches & pains continued intermittently;									N	12/10/1990	12/12/1990	2	FANA-neg; RA latex-neg;	PVT	PVT	NONE	NONE		NONE~ ()~~~In patient	891012005B	1						1	Arthritis; Myalgia; Pain	FLUX~PFIZER\WYETH~4908191~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0033310	10/15/1991	VA	41.0	41		F	12/26/1990	Pt devel swelling, redness, & warmth @ inject site p/receiving Influenza vax; pts upper arm was tender;									Y	11/12/1990	11/13/1990	1	NONE	PVT	PVT	NONE	NONE	pt has allergy to bee sting	~ ()~~~In patient	891012006B	1						1	Injection site hypersensitivity; Injection site oedema; Pain; Vasodilatation	FLUX~PFIZER\WYETH~4908186~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0033311	10/15/1991	NY	53.0	53		M	12/27/1990	Pt devel generalized peripheral neuropathy approx 1 wk p/receiving vax; pt was dx as having hypersensitivity angitis; given meds; pt exp anaphylactoid rxn to Ceftin, 1 wk p/receiving Influenza vax;				Y					N	12/03/1990	12/09/1990	6	Factor VIII ANtigen-inc; ESR-14 mm/hr	PVT	PVT	NONE	NONE	Pt allergic to Cipro		891012007B	1						1	Neuropathy peripheral; Vasculitis	FLUX~PFIZER\WYETH~4908201~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0033312	10/15/1991	PA				F	01/08/1991	Pt exp a burning sensation & discomfort (pain) @ inject site immediately p/receiving Influenza vax; sx subsided 15-25 seconds p/the inject, no other problems were noted in this pt;									Y	11/01/1990	11/01/1990	0		PVT	PVT	Several unspecified	NONE	The reporter possibly recalls the pt having hypertension & diabetes;	NONE~ ()~~~In patient	891012012B	1						1	Injection site pain	FLUX~PFIZER\WYETH~4908201~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0033313	10/15/1991	PA				U	01/08/1991	Pt exp a burning sensation & discomfort (pain) @ inject site immediately p/receiving Influenza vax; sx subsided 15-25 seconds p/the inject, & no other problems were noted in pt;									Y	11/01/1990	11/01/1990	0		PVT	PVT	Several Unspecified	NONE	The reporter recalls pt having hypertension & diabetes;	NONE~ ()~~~In patient	891012013B	1						1	Injection site pain	FLUX~PFIZER\WYETH~4908201~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0033314	10/15/1991	MA	57.0			F	01/11/1991	Pt recvd 1/2 dose of Influenza vax on two separate occasions one month apart, in arm; P/1st dose pt exp severe h/a lasting several hrs, followed by bone & joint pains lasting 2 to 3 days; w/remaining dose, pt exp tingling & numbness of lip;									U	10/15/1990				OTH	OTH	Unspecified daily vitamin, APAP as needed;		Pt has a hx of rxn to Meperidine, smallpox vax, Typhoid vax; Pt recvd flu vax 2 or 3 time in past, 4 yrs;	Pt exp cold & flu-like sx following flu vax;~ ()~~~In patient	891017007B	1						1	Injection site pain; Paraesthesia	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0033315	10/15/1991	CA	37.0	37		F	01/29/1991	Pt inadvertently recvd Influenza vax IV in place of Ativan inject; 3-4 days p/recving vax, pt devel pustular, maculopapular rash more dense on face & neck, & less dense on upper arms, shoulders & chest; pt felt feverish; dx viral exanthema;				Y					Y	01/17/1991	01/20/1991	3		PVT	PVT	Doxorubicin, Vincristine, Lorazepam	stage II breast cancer	pt has stage II breast cancer w/bone metastases & is allegic to sulfa;	~ ()~~~In patient	891031013B	1						1	Infection; Pyrexia; Rash maculo-papular; Rash pustular	FLUX~PFIZER\WYETH~4908200~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0035165	10/15/1991	MI				F	01/22/1991	Pt exp a large area of erythema & warmth (approx 5 x 3) @ inject site p/receiving Influenza vax; Pt recovered in five to six days;									Y	12/03/1990	12/03/1990	0		PVT	PVT	UNK			~ ()~~~In patient	891031014B	1						1	Injection site hypersensitivity; Vasodilatation	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0035166	10/15/1991	MI	52.0	52		F	01/22/1991	Pt exp a large area of erythema & warmth (approx 8cm) @ inject site p/receiving flu vax; This persisted for 3 days w/complete resolution of sx occuring 1 wk p/vax;									Y	09/08/1990	09/09/1990	1		PVT	PVT	Slo-Bid, Ventolin inhaler	NONE	Pt has a hx of asthma & hyperlipidemia; Pt previously recvd flu vax 19OCT89;	~ ()~~~In patient	891031015B	1						1	Injection site hypersensitivity; Vasodilatation	FLUX~PFIZER\WYETH~4908190~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0035167	10/15/1991	TX	37.0	37		F	02/01/1991	Pt devel sensory sx in the feet & perineum about 1 wk p/receiving flu vax; pt noted numbness of the toes, which spread to feet & ascended to level of ankles; achiness in lower extremities; loss of sensation in perineal area;									U	11/15/1990	11/23/1990	8	Blood chem, wintrobe Sed rate, rapid plasma reagin, Thyroid stimulating hromone, ANA all normal; MRI of lumbar-unusually low-lying conus medullaris (tip slightly about L2-3 discs), which was normal in congifuration & had no assoc abnormal;	PUB	OTH	NONE	NONE	trauma to rt external ear, req plasti surgery; head trauma produced LOC w/concussion & pt was hospitalize for a period of time; disturbance of vision & continues to have diplopia on the lt & rt lateral gaze; Also trouble w/balance;	~ ()~~~In patient	891036001B	1						1	Myalgia; Neuropathy; Paraesthesia	FLUX~PFIZER\WYETH~4908196~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0035168	10/15/1991	NJ	40.0	40		F	08/01/1991	Pt exp dizziness beginning night following flu vax, & continuing to the present; pt has hx of vertigo, MD did not think the dizziness was caused by flu vax; MD noted pt had chronic dizziness for yrs, which is aggravated by any meds;									U	11/26/1990	11/27/1990	1		PVT	PVT	NONE	NONE	Pt has a hx of vertigo of unk etiology & duodenitis;	~ ()~~~In patient	891059014B	1						1	Dizziness	FLUX~PFIZER\WYETH~4908197~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0035481	10/15/1991	AK	34.0	34		F	10/03/1991	10 hrs p/shot felt exhausted, nauseated, h/a, body ache, froze to death, fluctuating heart beat; stayed in bed 11 hrs, then went to work, felt puny w/intermittant nausea x 2 days;									Y	10/01/1991	10/01/1991	0	NONE	UNK	UNK				~ ()~~~In patient	AK91025	1						1	Arrhythmia; Asthenia; Chills; Headache; Myalgia; Nausea	FLU3~CONNAUGHT LABORATORIES~1F21213~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0035494	10/15/1991	MD	57.0	57		M	10/10/1991	Bells Palsy devel 2 days p/receiving vax;								Y	U	09/25/1991	09/26/1991	1		PVT	PVT	Lasix, Hybin	HBP, Prostate Hypertrophy	NONE	NONE~ ()~~~In patient		1						1	Facial palsy	FLUX~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0035499	10/15/1991	MI	78.0	78		M	10/09/1991	Pt recvd flu vax @ 10AM & by noon began to feel weak; By dinner time throat felt like had had a shot of novicaine; also c/o feeling shaky but says this occurs quite easily; Did not notify MD or ER; voice is still not right, lips numb;									Y	10/08/1991	10/08/1991	0	NONE	PUB	PUB		NONE	only hayfever	~ ()~~~In patient		1						1	Asthenia; Dysphonia; Nervousness; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~1F21216~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0031380	10/16/1991	CT	61.0	61		M	10/24/1990	12 days p/receiving inject, pt exp generalized weakness; next day could not walk & was hospitalized; 13OCT pt markedly weak, difficulty breathing, & had inc CSF protein; 4 days later was intubated & started on respirator; GBS;			Y		Y	30			N	09/28/1990	10/10/1990	12	CSF Protein 11OCT90 60;  13OCT90 CSF Protein>120;	PVT	PVT	Nitropatch, Procardia, Vasotec;		hx of hypertension, arteriosclerotic heart disease, myocardial infarction, & anxiety; pt had a cold one month prior to hospitalization;	~ ()~~~In patient	890318008B	1						2	CSF test abnormal; Guillain-Barre syndrome; Myasthenic syndrome; Asthenia; CSF test abnormal; Dyspnoea; Guillain-Barre syndrome; Hypokinesia; Weight decreased	FLUX~PFIZER\WYETH~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4908183~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation	Influenza
0035524	10/16/1991	NJ	49.0	49		M	10/15/1990	following vax pt devel GBS; sx included weakness & tingling in the legs; Hospitalization was required due to progressive weakness; pt improved p/an initial course of 5-6 plasmapheresis tx; 1 wk later, pt was retreated w/5-6 plasmapheresis;					Y	10			N	09/27/1990	10/07/1990	10		OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	890312002B	1						1	Asthenia; Guillain-Barre syndrome; Paraesthesia	FLUX~PFIZER\WYETH~4908201~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0035525	10/16/1991	IL	74.0	74		F	06/11/1991	Pt devel GBS w/paralysis approx 3 wks p/receiving influenza vax; pt believes the vax caused this problem;			Y		Y	21	Y		U	12/04/1990	12/19/1990	15	UNK	PVT	PVT	UNK	unk	unk	~ ()~~~In patient	891198011B	1						1	Guillain-Barre syndrome; Paralysis	FLUX~PFIZER\WYETH~4908195~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0035526	10/16/1991	WI	55.0	55		F	06/07/1991	Pt devel GBS p/receiving influenza vax; sx included numbness & tingling in hands, feet, & lt side of face; weakness in limbs; & elevation in BP; pt hospitalized on 24NOV90 & treated w/meds;				Y	Y	15		Y	U	11/09/1990	11/24/1990	15	A review of the batch record for lot# 4908194 was satisfactory w/no anomalies noted;	OTH	OTH	Pt recvd Hep B vax on 28SEP90 & 29OCT90;	NONE	NONE	NONE~ ()~~~In patient	890354001B	1						1	Asthenia; Guillain-Barre syndrome; Hypertension; Paraesthesia	FLUX~PFIZER\WYETH~4908194~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0035566	10/21/1991	AR				F	10/14/1991	Sz & rash reported by pt receiving fluogen; pt recvd flu shot in OCT88 & devel a rash that cleared in a few days; Approx 1 1/2 wks later, pt had a sz & was placed on Dilantin;									Y	10/01/1988	10/01/1988	0	n/s	OTH	OTH	n/s			~ ()~~~In patient	914088002	1						1	Convulsion; Rash	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0035646	10/21/1991	PA	62.0	61		F	10/01/1991	62 y/o pt immunized 24SEP91 & w/in 12 hrs post vax, pt exp weakness in the lt arm & leg; Hospitalized on 26SEP; dx w/transverse myelitis; tx w/high dose IV steroids; pt stable, still hospitalized as of 8OCT91;			Y		Y	30		Y	N	09/24/1991	09/24/1991	0	Cervical Myelogram-WBC 175; MRI-swelling C4-C6;	PVT	PVT	UNK	UNK	several medical problems-not specified	UNK~ ()~~~In patient	910183701	1						1	Myasthenic syndrome; Myelitis; Neuropathy	FLU3~LEDERLE LABORATORIES~312978~UNK~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0035648	10/21/1991	CA	62.0	62		F	10/01/1991	Lips started swelling @ 1230; started eating lunch, throat started closing; went to ER 145PM BP 70/0; Kept in ER for 6 hrs, had sl lip swelling p/vax; no other sx; denies egg allergy; Had IV & other meds @ ER;				Y					Y	09/30/1991	09/30/1991	0	Random blood sugar;	PUB	PUB	Vasotec, Lasix, ASA	NONE	NIDDM, Hypertension	~ ()~~~In patient	CA91121	1						1	Face oedema; Pharyngitis	FLUX~PFIZER\WYETH~4918154~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0035721	10/22/1991	OK	80.0	80		M	10/07/1991	Approx 5 hrs p/shot Pt started chilling & shaking & temp reached 102.8; Pt was hospitalized overnight & next day felt fine;				Y	Y	1			Y	10/03/1991	10/03/1991	0	CBC was normal;	PVT	OTH	Micronase; Nitro-Bid; Lanoxin;	None;	Diabetes; high blood pressure; heart disease;	No;~ ()~~~In patient	OK9158	1						1	Chills; Pyrexia; Tremor	FLU3~CONNAUGHT LABORATORIES~1F21214~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0035723	10/22/1991	OK	71.0	71		F	10/01/1991	30SEP91 Pt recd shot @ 330PM; 1OCT91 @ 130AM Pt suffered severe aches all over body & in bones; nauseated but didn't vomit; Pt took Motrin; MD's ofc advised Pt to continue w/Motrin & rest, also to report back to ofc if symptoms persist;									U	09/30/1991	10/01/1991	1	N/A	PVT	OTH	None;	None;	Diabetic;	No;~ ()~~~In patient	OK9160	1						1	Bone pain; Myalgia; Nausea	FLU3~CONNAUGHT LABORATORIES~1F21214~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0035817	10/24/1991	MD	50.0	50		F	10/17/1991	Around 2.5 hrs p/receiving flu vax pt began feeling achy & tired; skin is cool & clammy to touch;									Y	10/17/1991	10/17/1991	0	NA	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Hyperhidrosis; Myalgia	FLUX~PFIZER\WYETH~4918154~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0035834	10/25/1991	KS	62.0	62		F	12/07/1990	8NOV tired, no temp, h/a, coughing, drainage from throat, put on ATBs; 30NOV still having headaches & no energy;				Y					Y	10/25/1990	11/28/1990	34	NONE	PUB	PUB		NONE	NONE	~ ()~~~In patient	KS91066	1						1	Asthenia; Cough; Headache; Malaise	FLUX~PFIZER\WYETH~490813~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0035925	10/31/1991	NY	68.0	68		F	10/25/1991	Pt devel malaise & fever approx 4 days p/vax was administered; When examined on 22OCT91 pt had palpable purpura; Skin biopsy performed currently on Pred;									U	10/15/1991	10/19/1991	4	Skin biopsy pending; WBC-11.6; MCV-99.2; MCH-33.0; Sed rate-41; Chloride-95; CO2-34; Cholesterol-269; Phos-2.5; Bilirubin Total-1.3; AST/SGOT-182; ALT/SGPT-227; LDH-290; Glucose-201;  22OCT91 abnormal- Spec gravity-1.030; Protein-4+;	PVT	PVT		NONE	NONE	NONE~ ()~~~In patient		1						1	Albuminuria; Hepatic function abnormal; Leukocytosis; Purpura; Pyrexia; Red blood cell sedimentation rate increased; Respiratory acidosis; Vasculitis	FLU3~CONNAUGHT LABORATORIES~1F21200~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0035928	11/01/1991	FL	77.0			M	10/28/1991	Stevens-Johnson synd reported in pt receiving Fluogen; Pt recvd vax 18OCT91 & became very tired & achy that night had fever, chills, h/a & loss of equilibrium; Seen in office on 22OCT91 & found to have blisters on ear; eye swollen shut;									U	10/18/1991	10/18/1991	0		PVT	OTH	Levothyroxine sodium, synthroid, tagamet-cimetidine		N/S	~ ()~~~In patient	914091007	1						1	Asthenia; Coordination abnormal; Dermatitis bullous; Face oedema; Headache; Myalgia; Pyrexia; Stevens-Johnson syndrome	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0035935	11/01/1991	MO	72.0	71		F	10/22/1991	vax given afternoon 18OCT91 evening 18th fever (mild) headache, diarrhea, threw-up, not feeling well for two day 19th-20th;									Y	10/18/1991	10/18/1991	0	NONE	OTH	PUB	NONE	NONE	NONE	NA~ ()~~~In patient	MO9179	1						1	Diarrhoea; Headache; Malaise; Pyrexia; Vomiting	FLUX~PFIZER\WYETH~4918146~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0035937	11/01/1991	MO	15.0	15		M	10/24/1991	1 hr p/receiving flu vax pt reported hives @ inject site & the hives had spread all over body; Also c/o h/a, fever, nausea; Dad gave pt DPH no other tx obtained; No resp distress;									Y	10/23/1991	10/23/1991	0	NONE	PUB	PUB	NONE	NONE	NONE	NA~ ()~~~In patient	MO9181	1						1	Headache; Injection site hypersensitivity; Nausea; Pyrexia; Urticaria	FLUX~PFIZER\WYETH~4918146~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0035942	11/01/1991	OH	27.0	26		M	10/09/1991	Pt lost consciousness for about 10 seconds; pts eyes rolled back; paramedics administered oxygen; EKG performed dx vasovagal episode; Blood specimens taken to check for diabetes & kidney func;				Y					Y	10/06/1991	10/06/1991	0		OTH	PUB	NONE	NONE	Has a sac attached to heart; dx in 1974;	NONE~ ()~~~In patient	OH9188	1						1	Gaze palsy; Syncope	FLU3~PARKE-DAVIS~01381P~4~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0035964	11/01/1991	IL	69.0	69		M	10/18/1990	5 days p/flu shot pt noted weakness of lower extremities progressed to inability to walk & weakness in upper extremities;					Y	13			U	10/08/1990	10/13/1990	5	EMG-finding compatable w/diffuse neurogenic process w/inflammatory neuropathy; pt refused sp tap;	OTH	OTH	Synthroid, Humulin-NPH reg Insulin, Nitrodur, Lasix	Insulin dependent diabetic, renal failur	diabetic dependent on insulin, chronic renal failure, CHF, NKA;	~ ()~~~In patient		1						1	Asthenia; Hypokinesia	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0035966	11/01/1991	TX	60.0	60		F	10/28/1991	4 episodes of chills & fever to 102; no sweats;				Y					Y	10/25/1991	10/25/1991	0	NONE	PUB	PUB	Diabenese, Narosyn	NONE	NONE	~ ()~~~In patient		1						1	Chills; Pyrexia	FLUX~PFIZER\WYETH~4918174~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0035968	11/01/1991	NC	35.0	35		F	10/29/1991	Local redness & swelling @ inject site; generalized malaise, low grade fever, loss of appetite;				Y					U	10/23/1991	10/25/1991	2	NA	PUB	PVT	NONE	NONE	codeine-rash	~ ()~~~In patient		1						1	Anorexia; Injection site hypersensitivity; Injection site oedema; Malaise; Pyrexia	FLUX~PFIZER\WYETH~4918141~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0035972	11/04/1991	WA	30.0			F	10/28/1991	Recd vax 18OCT91 @430PM & @930PM awoke w/anxiety attack x15min & pain lt ear x30min & tinnitus & dec hearing lt ear; hx bilat tinnitus but claims tinnitus lt ear had new pitch; rx pred 30mgs BID; pt stop pred p/1st dose; 21OCT91 sx cont;									U	10/18/1991	10/18/1991	0	None;	PVT	OTH	Unknown;			~ ()~~~In patient	914091016	1						1	Anxiety; Condition aggravated; Deafness; Ear pain; Tinnitus	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0035983	11/04/1991	IL	26.0	26		M	10/29/1991	Pt is epileptic & suffers from cerebral palsy; 25OCT temp to 104 triggering epileptic seizure; 26OCT of 102; mom gave seizure medication & packed pt in ice packs;									Y	10/25/1991	10/25/1991	0		PUB	PUB	Dilantin, Valium, Zentac;		Cerebral Palsy & Epilepsy;	~ ()~~~In patient	IL9184	1						1	Condition aggravated; Pyrexia	FLU3~CONNAUGHT LABORATORIES~1F21209~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0036015	11/04/1991	VA	62.0	62		F	10/21/1991	1/2 hr p/vax, pt devel stiffness & pain in both legs; had pain & stifness from bottom of back to middle of back; could not raise up;									Y	10/16/1991	10/16/1991	0		PUB	PUB	Premarin, HCTZ	NONE	Arthritis, deteriating bone in lower back allergic to PCN	NONE~ ()~~~In patient	VA91090	1						1	Back pain; Hypertonia; Hypokinesia; Pain	FLU3~CONNAUGHT LABORATORIES~1F21216~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0036019	11/04/1991	WV	65.0	65		M	10/10/1991	Pt recvd vax 22SEP91 c/o vague malaise beginning 25SEP but not enough discomfort to interfere w/daily activities; 26SEP91 @ home 5AM severe episodes of respiratory difficulty p/3 home ventilation treatments pt drove self to hosp ER;			Y	Y	Y	7			Y	09/22/1991	09/26/1991	4		PUB	UNK	Theodur, Brethine	NONE	asthmatic-took allergy inject for dust, mold for about 18 months, recent testing-med d/c 3 mos ago;	NA~ ()~~~In patient	WV9140	1						1	Dyspnoea; Malaise	FLU3~PARKE-DAVIS~010171P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation	Influenza
0036022	11/04/1991	WV	69.0	69		F	10/24/1991	Pt recvd vax 23OCT91 felt fine until approx 1PM 23OCT91; Pt did not seek medical help; c/o SOB, copious clear expectoration, fever of 104, took ASA, forced fluids, was afebrile & feeling fine by 8AM 24OCT91;									Y	10/23/1991	10/23/1991	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	WV9143	1						1	Dyspnoea; Pyrexia; Salivary hypersecretion	FLU3~PARKE-DAVIS~01071P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0036093	11/05/1991	WA	21.0	21		F	10/18/1991	Pt c/o facial itching, tingling of face almost immediately p/vax; pt became diaphoretic, nauseous, BP 120/100; Given DPH; Also began shaking & feeling lightheaded; Went to pvt MD who recommended DPH;									Y	10/18/1991	10/18/1991	0		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	WA91631	1						1	Dizziness; Hyperhidrosis; Hypertension; Nausea; Paraesthesia; Pruritus; Tremor	FLUX~PFIZER\WYETH~4918147~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036101	11/05/1991	MI	58.0	58		F	10/31/1991	On 5th day p/vax pt exp flu sx & chest pains; rt side felt paralyzed; diarrhea sx started leaving & was able to go to MD 3 days later;				Y					Y	10/11/1991	10/16/1991	5		PUB	PUB	Synthroid, Cogard, vitamin	Broken toe	Thyroidectomy, melanoma of lymph nodes, colostomy, breast lumps removed;	Mom had GBS following flu vax yrs ago did recover but now deceased;~ ()~~~In patient		1						1	Chest pain; Diarrhoea; Hemiplegia; Influenza	FLU3~CONNAUGHT LABORATORIES~1F21216~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0036115	11/05/1991	NY	35.0	35		F	10/30/1991	Viral synd c/o generalized aches & pains, malaise & fever-flank pain;				Y					U	10/28/1991	10/30/1991	2	Urine c/s & u/a	PUB	PUB	Pt recvd TD by Wyeth lot# 491805 & MMR by MSD lot# 1141T on 27SEP91	NONE	NONE	~ ()~~~In patient		1						1	Back pain; Influenza; Malaise; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~4918154~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~1151T~2~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0036126	11/06/1991	NC	2.0	2	.4	M	10/23/1991	Sudden onset fever 103.5 seizure activity, eyes rolled back, generalized stiffness;				Y	Y				Y	10/04/1991	10/04/1991	0	CBC/UA/EEG;	PVT	UNK			NONE	NA~ ()~~~In patient	NC91085	1						1	Convulsion; Gaze palsy; Hypertonia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~1F21209~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0036128	11/06/1991	MD	63.0	63		M	11/04/1991	P/flu shot on 2OCT91 severe cold 3 days later; diarrhea & flu 2 wks p/shot; h/a w/fever not usually present; congestion in chest, mild cough, & sore or raw throat; elbows hurt; sick & bedridden most of 6 wks;									Y	10/02/1991	10/05/1991	3		PVT	UNK		psoriosis	allergic to cats, grass, dust (mostly cats)	~ ()~~~In patient		1						1	Arthralgia; Drug ineffective; Infection; Influenza; Lung disorder; Malaise; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~1F21201~2~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0036129	11/06/1991	NH	68.0	68		M	11/01/1991	fever, aches, diarrhea, coughing;									Y	10/22/1991	10/23/1991	1	NONE	PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Cough; Diarrhoea; Myalgia; Pyrexia	FLU3~PARKE-DAVIS~04261P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0036141	11/08/1991	GA	60.0	60		F	10/17/1991	Pt recd vax 11OCT91; 12OCT91 exp malaise, nausea, fever, lt foot swollen; 13OCT91 choking, difficulty swallowing; 14OCT91 rash, lips & nose swollen, red streaks from lt toe to lt ankle; Saw MD on Pred & DPH; 15OCT91 boil drained lt foot;				Y					Y	10/11/1991	10/12/1991	1	MD dx allergic rxn to flu vax;  Pt felt something might have bitten the foot; normal blood chemistry;	PUB	PUB		NONE	allergies-sulfa, erythromycin	~ ()~~~In patient	GA91271	1						1	Dysphagia; Face oedema; Malaise; Nausea; Oedema peripheral; Pyrexia; Rash; Skin striae	FLUX~PFIZER\WYETH~4918145~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036164	11/08/1991	GA	68.0	68		F	10/08/1991	PC from Med ctr; admitted via ER @ 11AM w/ c/o feeling weak; has past hx of brain tumor, sz & hypertension on Tegretol & BP meds; no sz activity noted toady;				Y	Y				U	10/07/1991	10/08/1991	1		PUB	OTH	Tegretol ?BP meds	NONE	Hx of brain tumor, szs & hypertension;	~ ()~~~In patient	GA91294	1						1	Asthenia	FLUX~PFIZER\WYETH~498145~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~308911~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0036172	11/08/1991	MS	69.0	69		F	10/25/1991	Large red, swollen area around site of inject; not painful hot to touch;									Y	10/24/1991	10/24/1991	0	NONE	PUB	PUB	Voltraren	NONE	arthritis	NONE~ ()~~~In patient	MS9149	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLUX~PFIZER\WYETH~4918153~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036177	11/08/1991	IN	44.0	43		M	11/04/1991	Swollen, erythematous rt deltoid area, fever >102, malaise, prostration, generalized myalgias, ?confusion;				Y					Y	10/29/1991	10/30/1991	1	3NOV91 WBC 5,100; 4% EOS;	PVT	PVT	NONE	persistent hepatitis C	NONE	~ ()~~~In patient		1						1	Asthenia; Confusional state; Malaise; Myalgia; Oedema; Pyrexia; Rash	FLUX~PFIZER\WYETH~1F21218~1~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~308912~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0036227	11/12/1991	GA	78.0	78		F	10/29/1991	Redness & swelling day p/vax (TD) given; On 6th day diffuse splotchiness below site (LUA) about size of grapefruit;									Y	10/22/1991	10/23/1991	1	NONE	PUB	PVT	Water pill, Potassium, Arthritis pill	NONE	Arthritis	NONE~ ()~~~In patient	GA91303	1						1	Oedema; Urticaria; Vasodilatation	FLU3~PARKE-DAVIS~04261P~6~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~CONNAUGHT LABORATORIES~1F31058~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0036232	11/12/1991	MO	58.0	58		F	10/17/1991	Local erythema, swelling, pain to deltoid area x 24 hrs; Instructed to apply ice to site then heat p/48hrs; required ice only 24 hrs; Felt feverish x 24 hrs; c/o malaise, dizziness, fell in home PM p/shot recvd resulting in back pain;									Y	10/09/1991	10/09/1991	0		OTH	PUB	Darvocet, Elavil, Centrum, Terex;	muscular dystrophy	muscular dystrophy	Pt exp weight loss, anorexia @ 57 w/flu shot #1;~ ()~~~In patient	MO9182	1						1	Back pain; Dizziness; Injection site hypersensitivity; Injection site oedema; Injection site pain; Malaise; Pyrexia	FLUX~PFIZER\WYETH~4918146~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036235	11/12/1991	NH	75.0	75		F	10/31/1991	3 cm x 2 cm firm edematous area lt deltoid; 0 redness, 0 pain, 0 paresthesia, lungs bil clear; 0 chest pain or resp difficulty; t98.5, p80 reg, r 20, BP 160/76; warm pack to lt deltoid region for 20 mins;									Y	10/23/1991	10/23/1991	0	NA	PUB	OTH	NA	local reaction	NA	~ ()~~~In patient	NH91017	1						1	Oedema	FLUX~PFIZER\WYETH~491820~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036236	11/12/1991	NH	76.0	76		F	10/31/1991	Fuzzy h/a, chest felt funny-discomfort;									Y	10/23/1991	10/23/1991	0	NA	PUB	OTH	Ducril, Propane			~ ()~~~In patient	NH91018	1						1	Chest pain; Headache; Pain	FLUX~PFIZER\WYETH~491820~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036237	11/12/1991	NH	65.0	65		F	10/31/1991	Few mins p/vax c/o nausea, vertigo, chest pressure, PB 170/100, p72 reg; given Epi-notified MD; assessed x30min BP 140/74, p-76;									Y	10/23/1991	10/23/1991	0	NA	PUB	OTH	UNK	NONE	UNK denies allergies, denies cardiac disease	~ ()~~~In patient	NH91019	1						1	Chest pain; Hypertension; Nausea; Vertigo	FLUX~PFIZER\WYETH~491820~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036238	11/12/1991	NH	57.0	57		F	10/31/1991	Next day rt deltoid w/warm red area 2in x 2in; not raised, not tender but feels warmth; no edema;									Y	10/22/1991	10/23/1991	1	NA	PUB	OTH	UNK	NONE	denies allergies	~ ()~~~In patient	NH91020	1						1	Vasodilatation	FLUX~PFIZER\WYETH~491820~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036242	11/12/1991	TN	35.0	35		F	10/28/1991	Running nose, sneezing-face burning, similiar to when you have a fever; has had flu shot for 10 yrs never had this type of adverse event;										10/28/1991	10/28/1991	0		PUB	PUB			PCN	~ ()~~~In patient	TN91202	1						1	Pain; Rhinitis	FLU3~CONNAUGHT LABORATORIES~1F21220~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0036243	11/12/1991	TN	70.0	70		F	10/29/1991	Arm became sore 6-7 hrs p/vax & worsened over the next wk w/inc inability to flex the lower arm & severe pain when trying to use the shoulder; Seen by DO 18OCT89 who said nerve was involved; could feel knot down deep where shot  given;				Y					N	10/11/1991	10/14/1991	3		PUB	PUB	Naprosin	NONE	Arthritis	NONE~ ()~~~In patient	TN91203	1						1	Hypokinesia; Injection site mass; Neuropathy; Pain	FLU3~CONNAUGHT LABORATORIES~1F21218~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0036248	11/12/1991	TN	51.0	51		F	11/04/1991	feeling bad, hard time breathing; dx bronchitis & laryngitis;				Y					Y	10/31/1991	10/31/1991	0		PUB	PUB				~ ()~~~In patient	TN91208	1						1	Bronchitis; Dyspnoea; Laryngitis; Malaise	FLU3~CONNAUGHT LABORATORIES~1F21220~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0036249	11/12/1991	TN	62.0	62		M	11/04/1991	20 minutes p/immun felt faint that night felt like throat was closing; pt monitors blood pressure monitoring device seemed to go wild; heart beat was fast-160 beats a minutes; fibrillation;					Y	3				10/31/1991	10/31/1991	0		PUB	PUB				~ ()~~~In patient	TN91209	1						1	Dizziness; Pharyngitis; Tachycardia; Ventricular fibrillation	FLUX~PFIZER\WYETH~4918201~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0036250	11/12/1991	TN	75.0	75		F	11/04/1991	sore throat, cold, sneezing, tickle in throat;										10/28/1991	10/30/1991	2		UNK	UNK				~ ()~~~In patient	TN91210	1						1	Chills; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4918142~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036317	11/13/1991	IL	68.0	68		M	11/07/1991	Chest pain, fever 100;				Y	Y	4			N	10/18/1991	10/22/1991	4	segs-86, bands 5, lymph 4, mono 3, EOS 2;	PVT	PUB	Theodur, lasix, vasotec, vistaril; amitriptyline		hypertension, COPD, anxiety	~ ()~~~In patient		1						1	Chest pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~1F21209~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0036320	11/13/1991	IL	96.0			F	10/25/1991	chilling, achiness, nausea; inability to open hands, diarrhea; DPH;				Y					Y	10/22/1991	10/22/1991	0	WBC 9.5, Seg 51, Bands 3; Lymph 25; EOS-3; mono 1; atypical lymph 17;	PVT	PUB	Diazide	NONE	atrial fibrillation, hypertension	~ ()~~~In patient		1						1	Chills; Diarrhoea; Hypokinesia; Myalgia; Nausea	FLU3~CONNAUGHT LABORATORIES~1F21209~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0036325	11/13/1991	FL	38.0	38		F	11/08/1991	Swelling in fingers; rash on neck & face; arm red, swollen, hard @ site of inject; blurry vision; lightheaded;				Y					Y	11/06/1991	11/07/1991	1		PVT	PVT		NONE	sulfa, ASA	~ ()~~~In patient		1						1	Amblyopia; Dizziness; Injection site mass; Oedema; Oedema peripheral; Rash; Vasodilatation	FLUX~PFIZER\WYETH~4918142~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036328	11/13/1991	OR	33.0	33		M	10/21/1991	13OCT pt recvd vax; 15OCT91 had severe back went to ER & was admitted to Hosp & dx viral kidney infect; MD stated it was related to flu vax also exp nausea, vomiting, diarrhea;				Y					Y	10/13/1991	10/15/1991	2	Blood & Urine test-WNL	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Diarrhoea; Infection; Nausea; Renal impairment; Vomiting	FLUX~PFIZER\WYETH~4918147~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036329	11/13/1991	MD				U		18 hrs post vax pt exp pulmonary edema; not known whether vax had some triggering effect;														UNK	UNK				~ ()~~~In patient		1						1	Pulmonary oedema	FLUX~PFIZER\WYETH~4918144~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036330	11/13/1991	CA	44.0	44		F	11/06/1991	Red rash on face, chest, arms itching, skin feels burned mild chest congestion;									N	11/05/1991	11/06/1991	1	NONE	PVT	PUB	Elival	NONE	ATB, muscle relaxers	~ ()~~~In patient		1						1	Lung disorder; Pain; Pruritus; Rash	FLUX~PFIZER\WYETH~4918169~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036332	11/13/1991	NM	41.0	41		F		Vax being given, pt drew away as vax being injected; consequently, vax was given SQ dribbled onto outer layer of skin; Pt withdrew because med began burning; skin became red & painful & burned; site inject elevated, red & tender;									U	10/22/1991	10/22/1991	0	10 days p/vax drop of flu vax was placed on pts rt arm & no rxn occurred;	PVT	PVT	NONE	NONE		~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~IF21200~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0036342	11/13/1991	MD	60.0	60		F	11/06/1991	low grade fever, chills									Y	10/31/1991	10/31/1991	0		PVT	UNK	Esidrix	NONE	hypertension	~ ()~~~In patient		1						1	Chills; Pyrexia	FLU3~LEDERLE LABORATORIES~310972~UNK~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0036344	11/14/1991	TX	60.0			M	10/28/1991	Pt exp mental confusion, slurring of speech, hypertension, & vomiting immediately p/vax; treated in ER w/meds; Seem to be improving but MD had pt admitted to hosp for continued observation;				Y	Y				U	10/28/1991	10/28/1991	0		PVT	PVT	UNK	UNK	UNK	Pt had similar rxn @ 40 w/Influenza;~ ()~~~In patient	891304014J	1						1	Confusional state; Hypertension; Speech disorder; Vomiting	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0036427	11/14/1991	WI	50.0	50		M	11/05/1991	230AM awakened by itching & burning red rash on face, neck, chest, & arms eyelids puffy; Later it was felt that pt was having rxn to Septra instead of vax;				Y					Y	11/04/1991	11/05/1991	1	NONE	PUB	OTH	Bactrim DS	Sinus infection	NONE	~ ()~~~In patient		1						1	Face oedema; Pain; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~IJ21108~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0036437	11/15/1991	OK	42.0	42		F	10/28/1991	Approx 6 hrs p/flu inject pt felt nervous; shortly thereafter pt noticed small red spots on lt arm (like mosquito bites) these becam very itchy & grew to nickle size whelps, they spread to rt arm & hand & to face; DPH taken;									N	10/22/1991	10/22/1991	0	NA	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	OK9165	1						1	Nervousness; Pruritus; Rash; Urticaria	FLUX~PFIZER\WYETH~4918169~7+~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036439	11/15/1991	OK	83.0	83		F	11/01/1991	10OCT91 vax recvd & 12OCT91 sore arm, h/a, fever, chills; MD put on symmetrel x 5 days; 25OCT91 stated temp down very weak could not stop coughing; Prescribed med by MD;									U	10/10/1991	10/12/1991	2	NA	PVT	OTH	Advil, Citricel, DIazide, Calan, Nitro patch, Prinivil	angina/edema	congestive heart failure, CASHD, hypertension, penporomandibular arthritis	NONE~ ()~~~In patient	OK9167	1						1	Asthenia; Chills; Cough; Headache; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~1F21214~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0036451	11/15/1991	NJ	43.0	43		F	11/12/1991	6 days post vax, devel hyperesthesias over lt side of face; no paresthesias, numbness, rash, URI or allergy sx; no motor deficits; Also had local rx p/inject arm pain, swelling @ inject site, w/swollen & tender ax lymph node;									Y	10/22/1991	10/28/1991	6	NONE	PVT	PVT	Axid 150mg BID	Epigastirc pains, dyspepsia	PCN allergy	NONE~ ()~~~In patient		1						1	Hyperaesthesia; Injection site oedema; Injection site pain; Lymphadenopathy	FLU3~CONNAUGHT LABORATORIES~1F21202~1~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0036453	11/15/1991	TX	27.0	27		F	10/21/1991	Mild urticarial eruption mid thighs to upper chest; DPH given; Has recvd flu shot every yr for past 10 yrs;									Y	10/21/1991	10/21/1991	0	urticaria resolved by 27OCT91;	OTH	PUB	Depakote seizures	NONE	no allergies, profound mental retard, partial trisomy 22;	~ ()~~~In patient		1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~1F21217~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0036454	11/18/1991	WV	60.0			M	11/11/1991	Transient hemiparesis, rhabdomyolysis, myoclobinuria, elevated CPK reported in pt receiving FLuogen; pt exp weakness, fatigue, malaise w/o feve & transient hemiparesis; pt hospitalized w/dx rhabdomyolysis & myoglobinuria;					Y	10			U	10/01/1991	10/01/1991	0	CPK=20,000	OTH	OTH	NONE			~ ()~~~In patient	914091019	1						1	Asthenia; Blood creatine phosphokinase increased; Hemiplegia; Malaise; Myopathy	FLU3~PARKE-DAVIS~01471P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0036459	11/18/1991	DE	70.0	70		F	10/29/1991	Pt recvd vax on 24OCT91 approx between 930-1230PM; pt stated that sx started 2AM on 25OCT91; pt states that also exp high fever, dizziness, vomiting, sweating & swollen rt arm;									Y	10/24/1991	10/25/1991	1	NONE	OTH	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	DE917	1						1	Dizziness; Hyperhidrosis; Oedema; Pyrexia; Vomiting	FLUX~PFIZER\WYETH~4918136~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~308912~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0036460	11/18/1991	DE	62.0	62		F	11/01/1991	Had a severe h/a for 4 days w/sinus congestion, vomiting one time, diarrhea for 2 days & teething;									Y	10/24/1991	10/25/1991	1	NONE	OTH	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	DE918	1						1	Asthenia; Diarrhoea; Headache; Rhinitis; Vomiting	FLUX~PFIZER\WYETH~4918136~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036462	11/18/1991	MO	72.0	72		M	11/01/1991	Flu vax given on 11OCT91, pt c/o stiffness all over body 6-7 days p/shot;									Y	10/11/1991	10/17/1991	6	NONE	PUB	PUB	Procardia, Nitrobid, 1 baby ASA, Hutrin	NONE	PCN allergy	NONE~ ()~~~In patient		1						1	Hypertonia	FLUX~PFIZER\WYETH~4918146~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036463	11/18/1991	MO	62.0	62		M	11/05/1991	Flu like sx, ichy eyes, cough, hard to breathe, congestion, chest ache;									Y	10/16/1991	11/02/1991	17	NONE	PVT	PUB	NONE	NONE	NONE	NA~ ()~~~In patient	MO9184	1						1	Chest pain; Cough; Dyspnoea; Influenza; Pruritus; Rhinitis	FLUX~PFIZER\WYETH~4918146~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036467	11/18/1991	NC	66.0	66		F	11/12/1991	Recvd flu shot on 18OCT91; states 24OCT91 had sore throat; states next day started coughing; took med w/o relief; states coughed all night 28OCT91 (in morning) went to urgent care; states there the MD told pt may have a slight case flu;				Y					Y	10/18/1991	10/24/1991	6	NONE	PUB	OTH	NONE	NONE	NONE	pt exp rxn w/flu @ 40 w/flu #1;~ ()~~~In patient	NC91091	1						1	Cough; Drug ineffective; Infection; Influenza; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~1F21215~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0036468	11/18/1991	NC	56.0	56		F	11/12/1991	Pt started w/burning & itching of trunk approx 5 min p/inject; taken to ER ahd DPH & Celestone; @ ER pt had chest pain; no diff breathing;				Y					Y	11/06/1991	11/06/1991	0	NONE (BP 140/80)	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient	NC91092	1						1	Chest pain; Pain; Pruritus	FLU3~CONNAUGHT LABORATORIES~1F21220~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0036479	11/19/1991	CA	55.0	54		F	01/16/1991	14NOV90 tingling & cold hands & feet; 16NOV90 Seen by MD tingling, hypersensitive to touch, no response to knee reflex, tired; 22NOV90 unable to eat much, trouble ambulating, slurred speech, vision problems; poss GBS, backache, low BP;					Y	16			N	10/31/1990	11/14/1990	14	LP x 1 28NOV MRI head/neck in hosp; 23DEC MRI head, to be repeated in April, Blood test in hosp thinks Ca & K was low; pt doesn't have results;	PUB	PUB	Premarin/Provera, Inderal	NONE	Hypertension, migraines, tremor in lt hand for 15 hrs controlled by inderal;	NONE~ ()~~~In patient	CA91126	1						1	Asthenia; Guillain-Barre syndrome; Hyperaesthesia; Hypotension; Myalgia; Paraesthesia; Speech disorder; Visual disturbance	FLU3~CONNAUGHT LABORATORIES~11222~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0036484	11/19/1991	CA	55.0	55		M	11/05/1991	Nauseated, dry heaves, dyspnea, paleness wife called EMT transported to ER; stay approx 2 hrs-released home saw pvt MD later same day;				Y					Y	10/31/1991	11/04/1991	4	Elevated K+	PUB	PUB	Clonidine, Calan, Coumadin, Tenormin	Hypertension myocardial infarct		~ ()~~~In patient	CA91131	1						1	Dyspnoea; Hyperkalaemia; Nausea; Pallor; Vomiting	FLUX~PFIZER\WYETH~4918170~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036485	11/19/1991	CA	64.0	64		M	11/05/1991	Onset 28OCT91, fever 103, cough, copious sputum, anorexia, pneumonia;					Y				N	10/24/1991	10/28/1991	4		PUB	PUB		Bronchitis chronic, heart problem	Severe bronchitis, CHF	NONE~ ()~~~In patient	CA91132	1						1	Anorexia; Cough; Pneumonia; Pyrexia; Salivary hypersecretion	FLUX~PFIZER\WYETH~4918169~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~302959~1~~~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0036486	11/19/1991	CA	78.0	78		F		At about MN, dizzy, unable to stand, vomiting; Ambulance transported pt to Hosp; treated w/IV ATB x 5 days, discharged on po ATB; no fever or cold sx; myalgia;				Y	Y	5			Y	10/10/1991	10/11/1991	1	CXR-showed Bilateral infiltrates;	PUB	UNK		NONE	Hypertension, mild heartattack in Jun, 1991	NONE~ ()~~~In patient	CA91133	1						1	Dizziness; Hypokinesia; Infection; Lung disorder; Myalgia; Vomiting	FLUX~PFIZER\WYETH~4918170~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0036494	11/19/1991	CA	74.0	74		F	10/28/1991	Temp elevation-pt unsure how high; sore red swollen arm from shoulders to elbow; dizziness, vomiting, weakness; Seen by MD arm sore 3-4 days other acute sx gone in 2 days;									Y	10/23/1991	10/24/1991	1	UNK- seen by MD;	PUB	PUB		NONE	UNK	NONE~ ()~~~In patient	CA91141	1						1	Asthenia; Dizziness; Myalgia; Oedema; Pyrexia; Vasodilatation; Vomiting	FLUX~PFIZER\WYETH~4918169~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036495	11/19/1991	CA	78.0	78		M	11/06/1991	Reported severe aching, nausea, dizziness, denies fever, weakness; T. consultation w/MD only; decided no need for MD visit unless temp becomes elevated;				Y					Y	10/31/1991	11/05/1991	5	NA	PUB	PUB		NONE	arthritis-gastritis r/o ulcers	pt had vax 1970 swine flu vax;~ ()~~~In patient	CA91142	1						1	Dizziness; Myalgia; Nausea	FLUX~PFIZER\WYETH~4918169~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036506	11/19/1991	NH	44.0	44		F	11/08/1991	Approx 1 hr p/annual flu shot felt itching then a rash devel over portions of jawline, around & behind lt ear small patch on upper lip & on cheeks; Small patch on neck & small amount on upper chest; rash is patched small confluent vesicles;				Y					Y	10/29/1991	10/29/1991	0		PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient	NH91021	1						1	Dermatitis bullous; Pruritus	FLUX~PFIZER\WYETH~4918153~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036507	11/19/1991	NH	54.0	54		F	11/08/1991	An apparent urticaria in & around the face, on forehead, cheeks, & chin; sx appear approx 48 hrs p/flu shot & continued 1 wk; sx subsided 7NOV91; tx wet soaks, hydrocortisone cream;				Y					Y	10/29/1991	10/31/1991	2		PUB	PVT	Terormin, Calan, HCTZ	NONE	Hypentension	~ ()~~~In patient	NH91022	1						1	Urticaria	FLUX~PFIZER\WYETH~4918153~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036508	11/19/1991	NV	12.0	12		F	11/08/1991	Severe local swelling, redness, pain @ inject site (lt deltoid); c/o chills, fever & generalized body ache; cold compress & APAP every 4 hrs given & despite-fever recorded @ 104F orally; s&s started day p/shot was given & persisted 5 days;									Y	11/05/1991	11/06/1991	1	NONE	PUB	PUB	NONE	NONE	NONE	NA~ ()~~~In patient	NV9122	1						1	Chills; Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia; Pyrexia	FLU3~PARKE-DAVIS~01481P~1~~RL~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~304908~1~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0036515	11/19/1991	WA	38.0	38		F	10/31/1991	Pt c/o SOB, dizziness, inability to breathe & throat swelling w/in 10 min p/shot, VS stable; pt given DPH; cont to c/o throat swelling; pt given epi;				Y					Y	10/28/1991	10/28/1991	0	Possible thimerosal rxn in past;	PUB	PUB	recvd wkly allergy shots	NONE	possible allergy to contacts serious problems from lens;	~ ()~~~In patient	WA91638	1						1	Dizziness; Dyspnoea; Pharyngitis	FLUX~PFIZER\WYETH~4918147~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~CONNAUGHT LABORATORIES~1H31128~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036517	11/19/1991	WA	43.0	43		F	10/31/1991	Arm swollen shoulder to elbow w/limited range of motion approx 3 days p/shot;									Y	10/25/1991	10/25/1991	0		PUB	PVT	Seldane, APAP, Griseofulzin; pt recvd Hep B by SKF lot# 638A4;	NA	allergies to grass & dust mite-took allergy shot p/flu	Pt exp swelling @ site @ age 43 w/ hep B dose 2;~ ()~~~In patient	WA91640	1						1	Hypokinesia; Oedema	FLUX~PFIZER\WYETH~4918141~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036520	11/19/1991	WA	48.0	48		F	11/01/1991	Red, swollen, bruised area noted on lt upper arm, midway between elbow & shoulder; Has become progressively larger & more tender since day p/vax;									Y	10/30/1991	10/31/1991	1	NA	PUB	PUB	Premarin, ASA	NONE	takes meds daily	~ ()~~~In patient	WA91643	1						1	Ecchymosis; Oedema; Pain; Vasodilatation	FLU3~PARKE-DAVIS~04161P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0036523	11/19/1991	UT	39.0	39		F	10/31/1991	Optic neuritis lt eye onset on awakening 0800 19OCT91;				Y				Y	U	10/18/1991	10/19/1991	1	Orbital CT scan-normal;	PVT	PVT	NONE	NONE	fuch's heterochromic iridocyclitis-both eyes	NONE~ ()~~~In patient		1						1	Optic neuritis	FLU3~LEDERLE LABORATORIES~310974~UNK~~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Disabling	Influenza
0036533	11/19/1991	CA	71.0	71		M	10/30/1991	Episcleritis/scleritis OD (red, irritated eye-no discharge); occurred 12 hrs a/ fever, chills which lasted approx 6 hrs;									Y	10/10/1991	10/13/1991	3	NONE	PVT	PVT	Allopurinol, HCTZ, MGO, B-6, K;	NONE	hypertension, renal calculi	NONE~ ()~~~In patient		1						1	Chills; Pyrexia; Scleritis	FLUX~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036534	11/19/1991	IN	39.0	39		M	11/15/1991	T104 R- 103.6 @ 110PM no other sx; CBC WNL temp resolved;									Y	10/17/1991	10/17/1991	0	CBC-WNL	OTH	OTH	MOM, Valium, Dilantin, Phenobarb, Colace		allergic to Dulcolax supp; porfound MR-mircociphaly, quadiplegia, epilepsy	NA~ ()~~~In patient		1						1	Pyrexia	FLU3~CONNAUGHT LABORATORIES~1F21218~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0036539	11/20/1991	LA	2.0	2	.2	M	11/01/1991	Recvd flu vax @ approx 11AM; At approx 2AM the following morning 12-13 hrs p/vax pt had inc temp of 103 & a rash on butocks, back & face; adverse rxn reported 24 hrs p/receiving vax & pt continued to have rash @ that time;									N	10/31/1991	11/01/1991	1	NONE	PUB	PUB	Provental, Intal	NONE	asthma, allergies to smoke	NA~ ()~~~In patient	LA911102	1						1	Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~1F21220~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0036541	11/20/1991	MO	63.0	63		M	11/06/1991	3NOV91 devel chills, inc temp, chest congestion, cough sputum greenish color;									Y	10/30/1991	11/03/1991	4	NONE	PUB	PUB	Hydrea	NONE	leukemia-immun given w/MD order	NA~ ()~~~In patient	MO9187	1						1	Chills; Cough; Infection; Lung disorder; Pyrexia	FLUX~PFIZER\WYETH~4918146~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036545	11/21/1991	AK	58.0	58		F	11/13/1991	Itchy eyes & yellow discharge from eye, pounding heart, hard to breath, probable mild allergic rxn;				Y					Y	10/15/1991	10/15/1991	0	NONE	PUB	OTH	Premarin, CA	NONE	allergic to PCN & ASA	~ ()~~~In patient	AK91026	1						1	Conjunctivitis; Dyspnoea; Hypersensitivity; Palpitations; Pruritus	FLU3~CONNAUGHT LABORATORIES~1F21213~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0036546	11/21/1991	AK	78.0	78		M	10/30/1991					Y					Y	10/16/1991	10/17/1991	1	Pt seen in ER 19OCT91 EKG etc done normal; PE by MD 29OCT91-nl	PUB	PUB	NONE	NONE	alzheimers	~ ()~~~In patient	AK91027	1						1	Unevaluable event	FLU3~CONNAUGHT LABORATORIES~1F21213~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0036547	11/21/1991	AK	52.0	52		F	10/30/1991	29OCT91 pt noticed soreness in mouth while eating breakfast; pt went to work @ hosp; @ lunch pt couldn't eat; seen in ER by MD who noted severe lymphadenopathy & mouth ulcers; pt described raised, pinkish lumps in mouth; sore throat;				Y						10/28/1991	10/29/1991	1	Viral culture of mouth ulcer -neg 14NOV91	PUB	PUB	Tagament	ONE	allergic to ASA, codeine, robaxin	NONE~ ()~~~In patient	AK91028	1						1	Anorexia; Lymphadenopathy; Mouth ulceration; Pharyngitis; Stomatitis	FLU3~CONNAUGHT LABORATORIES~1F21213~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1484S~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0036549	11/21/1991	AK	0.6	0	.6	M	11/05/1991	Immun given early afternoon-febrile by early evening; tempra given @ 9PM 1NOV91 pt crying @ 4AM mom attempted to feed but pt feel asleep; awake again @ 445AM very hot, had sz; Taken to ER still febrile seen by MD felt was febrile sz				Y					Y	11/01/1991	11/02/1991	1	CBC-neg, RPS, STF-differential all test normal	PUB	PUB	NONE	NONE	hypotonic since birth, slow growth, no specific diagnosis as yet	NONE~ ()~~~In patient	AK91030	1						1	Agitation; Convulsion; Febrile convulsion; Pyrexia	FLU3~CONNAUGHT LABORATORIES~1F21220~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0036558	11/21/1991	WV	63.0	63		F	11/14/1991	Approx 3 hrs p/vax recvd pt exp palpitaitons, weakness & blurred vision; Also was hypotensive 50-60/40 requiring IV fluids & hospitalization;			Y	Y	Y	3			Y	10/29/1991	10/29/1991	0	EKG's, cardiac enzymes & extensive stress test-all normal	PUB	PUB	Zantac & Pepzid tabs	alcoholic liver cirrhosis	peptic ulcer disease	~ ()~~~In patient	WV9149	1						1	Amblyopia; Asthenia; Hypotension; Palpitations	FLU3~PARKE-DAVIS~01401P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation	Influenza
0036561	11/21/1991	CO	50.0	50		F	11/12/1991	c/o dizziness, heaviness in chest, cough 2 hrs p/immun slight hives started p/this; t99.2, P90, BP 150/100; on nasal 02; Seen in ER & given DPH; Referred for allergy work up by MD;				Y					Y	10/08/1991	10/08/1991	0		PUB	PUB				~ ()~~~In patient		1						1	Chest pain; Cough; Dizziness; Hypersensitivity; Hypertension; Pyrexia; Urticaria	FLU3~CONNAUGHT LABORATORIES~1J21108~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0036567	11/21/1991	NY	65.0			M	11/15/1991	Pt exp watery bowel movements 6-8 days not relieved w/ OTC antidiarrhea, beginning w/in 48-72 hrs of vax, @ present lasting 3+ wks;									N	10/21/1991	10/23/1991	2	stool cultures pending;	OTH	PVT	Capoten, Lasix, ASA, Isordil	congestion heart failure	CAD, cardiomyopathy	NA~ ()~~~In patient		1						1	Diarrhoea	FLU3~PARKE-DAVIS~01581P~1~SC A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0036570	11/21/1991	MA	74.0	74		F	10/29/1991	Pt recvd shot @ 4PM & @ MN awoke w/severe h/a was feverish & explained that the rt lower extremity was swollen & covered w/red blotches; Rash present 29OCT;									N	10/22/1991	10/22/1991	0	skin scrapping	PUB	PUB	Cardizem, diretic	NONE	high BP	high blood pressure~ ()~~~In patient		1						1	Headache; Oedema; Pyrexia; Rash	FLUX~PFIZER\WYETH~4918201~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036572	11/21/1991		72.0			U		pulm edema;									U	10/16/1991	10/20/1991	4		UNK	UNK	Amantadine		h/o rhematic heart disease	~ ()~~~In patient		1						1	Pulmonary oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036577	11/22/1991	AL	87.0	87		F	11/14/1991	Pt is known to have COPD; had excerbation needing hospitalization from 28OCT91 to 5NOV91;					Y	8			Y	10/15/1991	10/28/1991	13		PVT	PVT		chronic medical condition but stable	COPD	~ ()~~~In patient	AL91033	1						1	Condition aggravated	FLUX~PFIZER\WYETH~4918132~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0036578	11/22/1991	AL	58.0	58		F	11/14/1991	Delayed local rxn w/erythema, induration, & edema resolved in 2-3 days;									Y	10/23/1991	10/23/1991	0		PVT	PVT		chronic medical condition	HT, thyroid problem, cancer of uterus	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLUX~PFIZER\WYETH~4918132~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036579	11/22/1991	AL	51.0	51		M	11/14/1991	Respiratory sx w/minimal bronchiolar infiltrate-needed hospitalization 9NOV91 to 11NOV91;					Y	3			Y	11/01/1991	11/08/1991	7		PVT	PVT		stable @ time of vax	hx of asthma	~ ()~~~In patient	AL91035	1						1	Respiratory disorder	FLUX~PFIZER\WYETH~4918132~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0036582	11/22/1991	OK	49.0	49		M	11/13/1991	c/o h/a severe, fatigue, malaise x 8 days;									N	11/05/1991	11/06/1991	1	refered to MD	PUB	PUB	unk	NONE	NONE	UNK~ ()~~~In patient	OK9171	1						1	Asthenia; Headache; Malaise	FLU3~CONNAUGHT LABORATORIES~1F21214~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~291954~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0036584	11/22/1991	OK	57.0	57		M	11/12/1991	TC from pt 29OCT91 reporting ached all over, had temp from 103-105; was in bed most of week; no pvt MD; also called ER was told poss sinus infection;									Y	10/28/1991	10/29/1991	1	NONE	PUB	PUB	Indocin when needed	NONE	allergic to PCN; hx of hypoglycemia, goout	NONE~ ()~~~In patient	OK9173	1						1	Infection; Myalgia; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~4918169~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036589	11/22/1991	PA	2.0	2	.5	F	11/18/1991	Pt is ventilator dependent ex premature pt w/severe development delay & hx of abnormal EEG in past that 9 days p/vax generalized sz lasting 2 hrs w/o response to Anticonvulsants;				Y	Y	4			Y	11/06/1991	11/15/1991	9	Theophyllene-10.4, Electrolytes NA-138; K-3.9, CL-101, CO2-32, Glu-153;	PUB	PVT	Flinstone Vit, KCL, Theolair, Dioril, Aldadone, Ventolin nebs, Potassium	NONE	developmental delay, BPD on ventilater- hx of abn EEG	~ ()~~~In patient		1						1	Convulsion	FLUX~PFIZER\WYETH~4918129~1~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0036590	11/22/1991	CA	36.0	36		F	11/12/1991	Date of vax & 2 days thereafter soreness, redness around inject site; 3 days p/inject developed limited ROM in shoulder joint; Now persistent pain & limited ROM lt shoulder since; continues @ present time 12NOV91;									N	11/01/1991	11/04/1991	3		PUB	PUB	NONE	NONE	asthma	NONE~ ()~~~In patient		1						1	Hypokinesia; Injection site hypersensitivity; Injection site pain; Pain	FLUX~PFIZER\WYETH~4918170~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~SCLAVO~136A2~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0036591	11/22/1991	MA	67.0	67		U		Posterior neck & post head pain, generalized aches & rash on neck & face; completely resolved in a couple of days;									Y	11/01/1991	11/04/1991	3	NONE	PUB	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						1	Headache; Myalgia; Neck pain; Rash	FLUX~PFIZER\WYETH~4918201~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036598	11/25/1991	AZ	65.0	65		F	11/12/1991	Itching on cheeks, around mouth, neck w/in 15 min of inject; returned to clinic, had no diff swallowing; nurse recommended DPH; took DPH went home & exp eyes swelling approx 30-45 min;									Y	11/12/1991	11/12/1991	0	NONE	PUB	PUB	NONE	NONE	dental anesthesia, adrenalin, bug sprays (repellant), codeine other meds;	~ ()~~~In patient	AZ9126	1						1	Face oedema; Pruritus	FLU3~LEDERLE LABORATORIES~314963~2~IM~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0036599	11/25/1991	CO	42.0	42		F	11/20/1991	Loss of breath to the point it became almost like an asthma attack; oxygen & epinepherin required;				Y					Y	10/23/1991	10/23/1991	0		PUB	PUB			asthma-(occasional bronchial inhaler)	~ ()~~~In patient	SC9191	1						1	Asthma; Dyspnoea	FLU3~CONNAUGHT LABORATORIES~1J21108~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0036600	11/25/1991	IL	39.0	39		M		Did not feel well (lt arm was reddened & sore on 19OCT91 had t101; 20OCT91 temp of 100F; took aspirin every 4-5 hrs; afebrile 21OCT91; redness of arm only slight;									Y	10/17/1991	10/18/1991	1		PUB	PUB				~ ()~~~In patient	IL9190	1						1	Malaise; Pain; Pyrexia; Vasodilatation	FLUX~PFIZER\WYETH~4918203~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~308913~1~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0036606	11/25/1991	MI	79.0	79		M	10/24/1991	On 16OCT91 devel a scratchy throat eyes burning, ache in body joints by Friday 18OCT91 had a raw throat; Saturday t100;				Y					U	10/15/1991	10/15/1991	0		PUB	PUB	BP meds, chemo for bladder CA	NONE	bladder CA	NONE~ ()~~~In patient	MI9199	1						1	Arthralgia; Eye pain; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~1F21201~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0036607	11/25/1991	MI	61.0	61		U		General aching/sore arm/fever, joint pains duration about 10 days;									Y	10/15/1991	10/16/1991	1		PUB	PUB		arthritis/jooint pains		~ ()~~~In patient	MI91100	1						1	Arthralgia; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~4918131~3~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036611	11/25/1991	MO	56.0	56		F	11/15/1991	9NOV91 numbness & tingling lower extremities; 10NOV91 could no longer stand; arms have movement but weak;grasp weak, vomiting, muscular pain, some difficulty swallowing;					Y	1			N	10/31/1991	11/09/1991	9	CBC-normal; p-3.6; otherwise chem normal; Electormogram; CSF; GM slain-neg; smear fangus-neg; glucose; protein, APT; electrolytes, SGPT, total CPK, sigmoid; LP revealed mild inc in portein in spinal fluid & GBS dx; CXR-normal	PUB	PUB	Advil, Cardizem	NONE	arthritis; hyperderssion sinc 3; hypothyroidism, allergic to PCN	~ ()~~~In patient	MO9190	1						1	Dysphagia; Guillain-Barre syndrome; Hypokinesia; Myalgia; Myasthenic syndrome; Paraesthesia; Vomiting; Asthenia; CSF test abnormal; Facial palsy; Guillain-Barre syndrome; Hyporeflexia; Myalgia; Paraesthesia; Quadriplegia	FLUX~PFIZER\WYETH~4918146~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4918146~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0036612	11/25/1991	MS	60.0	60		F	11/07/1991	Pt states approx 2 hrs p/vax was given, pt began having a fever of 101 to103 & a chill & aching severly; pt was taken to Hosp ER & admitted; This was pts 1st flu immun;				Y	Y	4			U	11/06/1991	11/06/1991	0	NONE	PUB	PUB		pt stated was healthy @ time;	had rt breast & lymph nodes removed p/each breast was dx;	~ ()~~~In patient	MS9151	1						1	Chills; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~4918153~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0036613	11/25/1991	NV	77.0	76		M	11/15/1991	28 hrs p/administration of flu vax, pt devel nausea; no vomiting; chills; diaphoresis; sl h/a & dizziness, & fever as high as 102; pt took APAP; pt states was in bed for 3 days; sx lasted for 10 days;									Y	11/01/1991	11/03/1991	2	NONE	PUB	PUB	APAP & Dimetapp PRN	NONE	hayfever; arthritis hips & both arms	NONE~ ()~~~In patient	NV9124	1						1	Chills; Dizziness; Headache; Hyperhidrosis; Nausea; Pyrexia	FLU3~PARKE-DAVIS~01481P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0036614	11/25/1991	NV	36.0	36		F	11/15/1991	20 hrs p/Pneumonococcal vax, rt arm swelled up & was very sore; low grade fever 99F (pt states body temp has always been sub-abnormal; w/chills; arthralgia; for which lasted 60 hrs; @ this date 15NOV91; rt arm is still sl swollen & bruised;									Y	11/08/1991	11/09/1991	1	NONE	PUB	PUB	Naprosyn, Zestril, Pepcid	NONE	HTN: peptic ulcer; hayfever	pt exp higher fever @ 8 y/o w/MR unk dose;~ ()~~~In patient	NV9125	1						1	Arthralgia; Chills; Ecchymosis; Myalgia; Oedema; Pyrexia	FLU3~PARKE-DAVIS~01481P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~304908~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0036618	11/25/1991	OR	30.0	30		F	11/14/1991	Began w/ 2 large red, raised areas on inner thighs & then spread to legs, feet, hands, face; Seen in ER 9NOV91 & 10NOV91 & dx as having erythema multform;				Y					Y	10/30/1991	11/06/1991	7		OTH	PVT	Ibuporfen, PCN, Flexeril	Sore neck	NONE	NA~ ()~~~In patient	OR9157	1						1	Erythema multiforme; Vasodilatation	FLUX~PFIZER\WYETH~4918147~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~1712S~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0036623	11/25/1991	SD	70.0	70		M	11/07/1991	20OCT91 pt expired;	Y	10/20/1991		Y					N	10/07/1991	10/20/1991	13	fasting Blood sugar-133 (pt IDDM)	PVT	PVT	Capoten, Hunalin N 45U, Hunalin R 10U	Cardiopulmonary arrest	diabetes (insulin) hypertension alzheimers	~ ()~~~In patient	SD91025	1						1	Hyperglycaemia	FLUX~PFIZER\WYETH~4918129~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0036624	11/25/1991	SD	85.0	85		M	10/28/1991	Nausea, vomiting, diarrhea started 9OCT or 10OCT, diarrhea stopped but was still nauseated; MD ordered Phenergan supp 13OCT91; congestive heart failure was reason for death;	Y	10/14/1991							N	10/08/1991	10/09/1991	1	total bilirubin results inconclusive;	UNK	UNK	HCTZ	NONE	arthritis, hypertension		SD91026	1						1	Diarrhoea; Nausea; Right ventricular failure; Vomiting	FLUX~PFIZER\WYETH~4918129~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0036625	11/25/1991	SD	56.0	56		F	10/18/1991	5 days loss of voice & severe cough; sore throat apparently from cough;				Y					Y	10/08/1991	10/18/1991	10	NONE	PUB	PUB				~ ()~~~In patient	SD91027	1						1	Cough; Dysphonia; Pharyngitis	FLUX~PFIZER\WYETH~4918132~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036626	11/25/1991	VA	52.0	52		M	11/14/1991	wk of 4NOV91, began w/general aching; On 11NOV91 had chills & aching in both hips; 14NOV91, exp nausea & diarrhea;									U	10/23/1991	11/04/1991	12		PUB	PUB	NONE	NONE	PCN	~ ()~~~In patient	VA91096	1						1	Chills; Diarrhoea; Myalgia; Nausea	FLU3~CONNAUGHT LABORATORIES~1F21216~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0036629	11/25/1991	MI	71.0	71		F	10/01/1991	C/o lt sided weakness became weak, lost strength; BP 190/100, t103.5 treated & released @ ER 28SEP; hospitalized 4 days later w/pneumonia ? sl stroke;				Y	Y	8			U	09/27/1991	09/28/1991	1	NONE	PUB	PUB		NONE	MS	~ ()~~~In patient		1						1	Asthenia; Cerebrovascular accident; Hypertension; Myasthenic syndrome; Pneumonia; Pyrexia	FLUX~PFIZER\WYETH~4918202~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0036630	11/25/1991	WI	36.0	36		U		Pt states never felt well since having flu shot; sx general malaise, pleurisys, weakness, flu (chronic);			Y						N	10/27/1978				PVT	UNK		fully recovered from mono		~ ()~~~In patient		1						1	Asthenia; Chills; Influenza; Malaise; Paraesthesia; Pleural disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0036631	11/25/1991	WI	85.0	85		F	11/19/1991	Generalized urticaria;				Y					Y	10/30/1991	11/02/1991	3	NONE	PVT	PVT	Amrodarone; Lasix, Hytrin, Nitro patch	NONE	inc BP, sick sinus synd, hx v tach fib, CHF	~ ()~~~In patient		1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~2171S~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0036636	11/25/1991	NH	36.0			F	11/18/1991															PUB	OTH		NONE	PCN; choleceptectomy 2OCT91	~ ()~~~In patient		1						1	Unevaluable event	FLUX~PFIZER\WYETH~4918125~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036644	11/26/1991	GA	72.0	72		M	10/01/1991	Pt became ill 2 days following inject; admitted to hosp because of dehydration; died 28SEP91; death certificate-ventricular fibrillation, hypoxia, aspiration, gastric contents;	Y	09/28/1991							N	09/23/1991	09/25/1991	2		UNK	UNK		Gastroenteritis	moderate to marked atherosclerosis, coronary artery		GA91311	1						1	Dehydration; Hypoxia; Malaise; Respiratory disorder; Ventricular fibrillation	FLU3~PARKE-DAVIS~0127P~3~UN~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0036651	11/26/1991	UT	69.0	69		F	11/01/1991	1st noticed elevated temp then rapid heart rate becoming more pronounced; went to ER about 1230AM; 17OCT91 w/inc temp, inc HR, inc BP & wheezing; EKG done; given DPH & APAP sx resolved but admitted for observatin until next AM;				Y	Y	1			Y	10/16/1991	10/16/1991	0	EKG-normal-lt on moniter until AM;	PUB	PUB	Micronase	NONE	PCN allergy (no allergy to eggs)- diabetes	~ ()~~~In patient	UT9126	1						1	Asthma; Hypertension; Pyrexia; Tachycardia	FLU3~CONNAUGHT LABORATORIES~1F21216~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0036652	11/26/1991	UT	74.0	74		M	11/07/1991	Pt had flu & pneumonia shot @ clinic 22OCT91; shots given in rt arm as pt had had cracked elbow; pt went outside next morning to shovel snow & redness & blotching were noticed on lower extremeties; legs warm to touch, sl redness inject site									Y	10/22/1991	10/23/1991	1	SMA-20;& CBC-normal x/sl inc glucose;	PUB	PUB	Calan & ASA	NONE	hypertension, CVA-1985, rheumatic fevers 1941;	~ ()~~~In patient	UT9127	1						1	Hyperglycaemia; Injection site hypersensitivity; Injection site oedema; Purpura; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~1F21216~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~304908~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0036653	11/26/1991	UT	3.0	3		M	11/07/1991	Pt was given flu shot @ 9AM on 4NOV91; mom reports pt was given APAP on ret to home; by 1PM appeared flushed, tired w/general malaise, tachycardia; t103 ax @ 10PM; started vomiting 11PM & vomited 6-7 x									Y	11/04/1991	11/04/1991	0	NONE	PUB	PUB	NONE	NONE	asthma	NONE~ ()~~~In patient	UT9128	1						1	Asthenia; Malaise; Pyrexia; Tachycardia; Vasodilatation; Vomiting	FLU3~CONNAUGHT LABORATORIES~1F21216~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0036656	11/26/1991	WI	70.0			M	11/21/1991	Pt recvd vax 7NOV91 & approx 1030 7NOV, pt felt lightheaded, nauseous, SOB; pt collapsed w/o LOC, & ambulance was called; pt was bradycardic (pulse 20's) atropine & epi given en route to ER; In ER had resp distress;			Y	Y	Y	4			Y	11/07/1991	11/07/1991	0		OTH	OTH	Atenolol, Norpace, synthroid		arrythmias (PAT, RBBB) xmany yrs; goiter; depression; peptic ulcer disease	~ ()~~~In patient		1						1	Bradycardia; Dizziness; Dyspnoea; Hypotonia; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0036657	11/26/1991	PA	14.0	14		M	11/22/1991	minutes p/the inject pt was SOB progressing to cyanosis & respiratory arrest; mouth to mouth resucitation, epi given x 3, DPH & albuterol, 02;					Y	1			Y	11/18/1991	11/18/1991	0	NONE	PVT	PVT	Slo bid, Ventolin, pred, allergy inject, vit B6, Beconase;	NONE	environmental allergies, asthma	~ ()~~~In patient		1						1	Apnoea; Cyanosis; Dyspnoea	FLU3~PARKE-DAVIS~04161P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0036659	11/26/1991	WI				U		Pt states became ill on about 3NOV91 & was dx w/pneumonia on xray; rx w/ATB; Pt is well now; reporting because the form says report any illness w/in 4 wks;				Y					Y	10/24/1991	11/03/1991	10		PUB	PUB			NONE	~ ()~~~In patient		1						1	Malaise; Pneumonia	FLU3~PARKE-DAVIS~01781P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~306906~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0036660	11/26/1991	WI	28.0	28		F	11/15/1991	Didn't feel good about 1 hrs p/immun 8 hrs later t102 & swelling of face; 18 hrs later eyelids & bridge of nose swollen; Seen by MD & referred to allergist;				Y					Y	11/14/1991	11/14/1991	0	GCP, CBC, UA	PUB	UNK				~ ()~~~In patient		1						1	Face oedema; Malaise; Pyrexia	FLUX~PFIZER\WYETH~4918131~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036665	11/26/1991	NY	53.0	53		F	11/12/1991	dizziness, pounding h/a, fatigue, orthostatic hypotension (2 hrs), local swelling @ inject site lasted for 5 days;				Y					Y	10/30/1991	10/30/1991	0	NONE	PVT	PVT	NONE	NONE	environment allergies, hay fever	pt exp rxn w/Hep B #2 dose;~ ()~~~In patient		1						1	Asthenia; Dizziness; Headache; Injection site oedema; Orthostatic hypotension	FLUX~PFIZER\WYETH~4918126~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036666	11/26/1991	WI	56.0	56		F	11/19/1991	Marked fatigue, nausea, dry mouth, blood pressure elevation w/in 1 hr of shot; all sx immediately disappeared w/Epi; seen in ER;				Y					Y	11/13/1991	11/13/1991	0	NONE	PVT	PVT	Calan, Premarin, Provera	NONE	hypertension	NONE~ ()~~~In patient		1						1	Asthenia; Dry mouth; Hypertension; Nausea	FLUX~PFIZER\WYETH~4918145~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036668	11/26/1991	MD	53.0	53		F	11/22/1991	Arthritis pain & swelling of all joints, especially hands; (every joint in hand affected) swelling & pain started one day p/inject persisted severly for 2 wks; lt knee & fingers still sl pain & swelling;									Y	10/17/1991	10/18/1991	1	NONE	OTH	OTH	Ascriptin	NONE	arthritis	~ ()~~~In patient		1						1	Arthritis; Osteoarthritis; Pain	FLUX~PFIZER\WYETH~4918154~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036672	11/26/1991	WI	83.0	83		M	11/01/1991	t99.6, PB 180/60, R18, P70 reg; pt c/o inability to move rt arm above waist level; reports an achiness from shoulder to elbow w/movement @ site; unable to adduct arm; rt hand cooler than lt; able to move fingers w/hand w/o difficulty;									Y	10/31/1991	10/31/1991	0	NONE	PUB	UNK	Tenorim, maxzide	NONE	hypertension/no known allergies	NONE~ ()~~~In patient		1						1	Hypokinesia; Myalgia; Peripheral vascular disorder; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0036162	11/27/1991	NC	36.0			F	11/21/1991	Anaphylactoid rxn reported; pt had 1st flu shot in NOV91 & had an immediate rxn characterized by coughing, rhinorrhea & tightness in throat (was in mild distress); pt was fine in 2 hrs w/o rx; no egg allergy;									Y	11/01/1991	11/01/1991	0	None stated;	OTH	PVT	None stated;	None stated;		~ ()~~~In patient	914091065	1						1	Anaphylactoid reaction; Cough; Dyspnoea; Pharyngitis; Rhinitis	FLU3~PARKE-DAVIS~~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0036675	12/02/1991	CO	67.0	67		F	10/21/1991	On 18OCT91, pt called to report very sore lt arm following shot on 11OCT91; 21OCT91 lt arm was very achy, felt miserable all over; no fever; area of induration approx 3 in diameter; swollen tender lymph nodes under lt arm;									Y	10/11/1991	10/12/1991	1		PUB	PUB	UNK	NONE	NONE	~ ()~~~In patient	CO9183	1						1	Lymphadenopathy; Malaise; Myalgia; Oedema; Pain; Pruritus; Skin nodule; Vasodilatation	FLUX~PFIZER\WYETH~4918146~UNK~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~CONNAUGHT LABORATORIES~1D31030~UNK~IM~LL~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0036676	12/02/1991	CO	64.0	64		M	10/21/1991	Flu shot on 11OCT & on 12OCT exp h/a, malaise followed by severe abdo pain, brief fever, loose stools, nausea; In bed for 2 days following shot; Seen by MD on 15OCT-exam & lab WNL; rx Cotrin-DS;				Y					Y	10/11/1991	10/12/1991	1	UA, Physical exam-neg;	PUB	PUB	Asedir daily			~ ()~~~In patient	CO9184	1						1	Abdominal pain; Diarrhoea; Headache; Hypokinesia; Malaise; Nausea; Pyrexia	FLUX~PFIZER\WYETH~4918146~5~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036690	12/02/1991	MD	4.0	4		M	10/29/1991	25OCT91 2PM pt began to vomit & cough; Seen by MD on 25OCT91; 26OCT91 1201AM broke out in red itchy bumps,t101 went to ER given 2 injects one for vomiting & 1 for allergic reaction; also given DPH;				Y					Y	10/25/1991	10/25/1991	0		PVT	UNK	Ceclor for ear infect; Theodur, liquid pred	asthma & ear infect	allergic to chicken, fish, eggs, milk, beans, butter, corn, wheat;	NONE~ ()~~~In patient	MD91089	1						1	Cough; Hypersensitivity; Pruritus; Pyrexia; Rash; Vomiting	FLUX~PFIZER\WYETH~4918170~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036693	12/02/1991	MD	67.0	67		F	10/31/1991	Pt recvd flu & pneumococcal vax on 22OCT91 @ 330PM & devel sore throat on 23OCT91 & on 29OCT91 pt saw pvt MD for cough, runny nose, chills, fever & sl achinesss; given antibiotic for red ear;				Y					Y	10/22/1991	10/23/1991	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MD91092	1						1	Chills; Cough; Ear disorder; Myalgia; Pharyngitis; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~49181511~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~308912~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0036694	12/02/1991	MD	66.0	66		M	10/25/1991	Pt phoned to report onset of flu-like illness 22OCT91, 1 wk p/receiving flu vax; pt reported to work 22OCT, but was unable to work next 3 days; c/o fever, sore throat, dec appetite;									Y	10/15/1991	10/22/1991	7	NONE	PUB	PUB	NA	denied	unk	unk~ ()~~~In patient	MD91093	1						1	Anorexia; Cough; Drug ineffective; Influenza; Pharyngitis; Pyrexia	FLUX~PFIZER\WYETH~4918154~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036699	12/02/1991	MN	32.0	32		F	11/20/1991	Strep throat treated w/PCN x 10 days;				Y					Y	11/06/1991	11/11/1991	5	+ strep from throat swab 15NOV91;	PUB	PUB	NONE	NONE	heart condition	~ ()~~~In patient	MN91049	1						1	Infection; Pharyngitis	FLUX~PFIZER\WYETH~4918201~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036700	12/02/1991	MN	64.0	64		F	11/20/1991	Throbbing pain from elbow to shoulder unable to raise arm unassisted by other arm occasionally relieved by use of Motrin-varies in intensity; occasionally feels warm to touch; called MD but was not seen; advised motrin;									N	10/30/1991	11/06/1991	7		PUB	PUB	Antivert inject for eczema	eczema	arthritis, meniere's disease	~ ()~~~In patient	MN91050	1						1	Hypokinesia; Pain; Vasodilatation	FLUX~PFIZER\WYETH~4918201~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036702	12/02/1991	MO	91.0	91		M	11/18/1991	09NOV91 became very weak, vomiting, poor appetite; continued to get weaker; 12NOV91 fever 101 continued for 2 days; 14NOV91 hospitalized for approx 1 day for tests; no rx - Home Health Nurse 3 x week;					Y	1			N	11/08/1991	11/09/1991	1		PUB	PUB	NONE	NONE	Allergic to penicillin;	NONE~ ()~~~In patient	MO9191	1						1	Anorexia; Asthenia; Pyrexia; Vomiting	FLUX~PFIZER\WYETH~4918146~5~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0036704	12/02/1991	MO	23.0			F	11/21/1991	Local rxn deltoid muscle w/soreness; cannot do any writing until 01NOV91;				Y					Y	10/28/1991	10/28/1991	0	NONE	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	MO9193	1						1	Hypokinesia; Injection site pain	FLUX~PFIZER\WYETH~4918146~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036710	12/02/1991	OK	39.0	39		F	11/20/1991	Vomiting, diarrhea, dehydration, fever, sore throat treatment @ hosp-Tagamet, Glucose/dextrose, Amoxillin;				Y	Y	4			Y	11/07/1991	11/11/1991	4	X-ray gallbladder & kidney for stones-normal; upper GI-normal; Ultra sound on stomach, gallbladder & liver-normal;	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	OK9177	1						1	Dehydration; Diarrhoea; Pharyngitis; Pyrexia; Vomiting	FLUX~PFIZER\WYETH~4918169~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0036722	12/02/1991	WI	51.0	50		F	11/19/1991	12NOV91 visual disurbances driving home from work; chills, anorexia, exhausted; numbness half body; half throat sore; no movement problems;				Y					U	11/07/1991	11/12/1991	5		PUB	PUB	Zanex	NONE	PCN; balance prob	~ ()~~~In patient		1						1	Anorexia; Asthenia; Chills; Paraesthesia; Pharyngitis; Visual disturbance	FLU3~PARKE-DAVIS~01784P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0036727	12/02/1991	IL	71.0	71		F	11/25/1991	vertigo, nausea, emesis, confusion, disorientation;					Y	5			Y	11/06/1991	11/14/1991	8	SGOT-6; Creat-0.6; Total port-5.5; CBC-normal;	PVT	PUB	Naprosyn, Zestaril, Premarin	NONE	PCN, Hypertensive	~ ()~~~In patient		1						1	Confusional state; Nausea; Vertigo; Vomiting	FLU3~CONNAUGHT LABORATORIES~1F21209~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0036730	12/02/1991	IA	71.0	70		F	11/26/1991	Swelling, erythema & tenderness of rt upper extremity; site of pneumovax inject;				Y					Y	11/15/1991	11/15/1991	0		PVT	UNK	Hytrin, Cytotec, Nalfon	NONE-routine office call	NKDA	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1852S~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0036731	12/02/1991	FL	68.0	68		M	10/28/1991	Pt achy, tired-low grade temp off & on; started 3 days past vax; Seen by MD 28OCT91 started on Amantadine; Called 1 wk later, still ill but better; 21NOV91 called pt, illness resolved;				Y					Y	10/16/1991	10/19/1991	3	WBC low;	PUB	UNK	NONE	NONE	hypoglycemic	~ ()~~~In patient		1						1	Asthenia; Malaise; Myalgia; Pyrexia	FLU3~PARKE-DAVIS~00971P~2~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0036735	12/02/1991	WI	55.0	55		F	11/19/1991	10NOV91 burning pain, numbness, sl weakness lt leg; 11NOV91 numbness, sl weakness lt arm; 12NOV91 seen by MD;				Y					N	11/08/1991	11/10/1991	2	UA-8-10 white cells-trace  leukocytes; CBC-WBC 5,900;HGB-12.9; sed rate-24; Glu-20;	PUB	PUB	Feldene, Capazid, arthritis meds;	NONE	PCN; Bactrim; Motrin; inc BP (on meds);	~ ()~~~In patient		1						1	Myasthenic syndrome; Pain; Paraesthesia	FLUX~PFIZER\WYETH~4918135~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036736	12/02/1991	CA	65.0	65		M	11/25/1991	Pt recvd Influenza A&B vax on 8NOV91 & 12NOV91 aobut 4PM pt devel a droopy mouth on rt side; Pt consulted MD & was referred to neurologist who dx bells palsy;	Y			Y					U	11/11/1991	11/12/1991	1	bells palsy	UNK	PVT		ESRD	chronic renal failure NKA	NONE~ ()~~~In patient		1						1	Facial palsy	FLUX~PFIZER\WYETH~10300080808020~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0036742	12/02/1991	MN	63.0	63		F	11/14/1991	Fever, chills, h/a x 3 days;									N	11/08/1991				PVT	PVT	Monogeril, Inderal, Xanax, Lopid, Triavil	Hypertension	NKA	~ ()~~~In patient		1						1	Chills; Headache; Pyrexia	FLU3~PARKE-DAVIS~01881P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0036743	12/02/1991	MN	76.0	76		F	11/19/1991	18NOV91 had general malaise achiness low grade temp 99.8 flu shot in 13NOV91 seen @ hosp in ER given symmetrall on 19JAN91; no rxn reported x 5 days;									N	11/13/1991	11/18/1991	5		PVT	PVT	Lanoxin, Capozide, Lasix, Halcion, Azhacort;	NONE know but COPD	Codeine ASA (GI upset)	NONE~ ()~~~In patient		1						1	Malaise; Myalgia; Pyrexia	FLU3~PARKE-DAVIS~01881P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0036745	12/02/1991	NY	27.0			M	11/18/1991	Sudden paleness & fell down in few seconds; flu vax administered w/dec BP;									Y	11/18/1991	11/18/1991	0		PVT	UNK			NONE	NONE~ ()~~~In patient		1						1	Hypotension; Pallor; Syncope	FLUX~PFIZER\WYETH~4918154~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036754	12/03/1991	WA	56.0	56		F	11/12/1991	Local rxn redness & swelling 8NOV91; hives; SOB; went to ER put on DPH 9NOV; swollen tongue; SOB Tues called MD; given DPH 12NOV91;				Y					Y	11/08/1991	11/09/1991	1		PUB	PUB	PCN	on PCN @ time for bad flu	client still on rx but much better; MD said to get flu shot;	~ ()~~~In patient	WA91647	1						1	Dyspnoea; Injection site hypersensitivity; Injection site oedema; Tongue oedema; Urticaria	FLUX~PFIZER\WYETH~4918147~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036755	12/03/1991	WA	68.0	68		F	11/15/1991	4-5 hrs p/vax, began w/nausea & had 4-5 bouts of vomiting through the night; This morning is nauseious, but vomiting seems relieved; mildly sore lt arm vax site; full head; no fever, h/a, diarrhea knows no one w/similiar sx;									U	11/14/1991	11/14/1991	0	NONE	PUB	PUB	Antihistamine for allergies @ HS		allergies	~ ()~~~In patient	WA91648	1						1	Headache; Injection site pain; Nausea; Vomiting	FLU3~PARKE-DAVIS~00971P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0036756	12/03/1991	WA	62.0	61		F	11/13/1991	Sl fever, chills, stomach cramps started Thurs AM 7NOV91; still cramping not feeling well; Has not contacted MD; 13NOV feeling better cramping remained thru 10NOV91; weak but ok now;									Y	10/29/1991	11/07/1991	9		PUB	PUB		NONE	NONE	~ ()~~~In patient	WA91649	1						1	Abdominal pain; Asthenia; Chills; Malaise; Pyrexia	FLUX~PFIZER\WYETH~4918147~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036757	12/03/1991	WA	65.0	65		F	11/13/1991	Tues PM 5NOV91 low stomach cramps hurt to sit; no fever; sl diarrhea @ first; not seen by MD; Husband has similar sx but did not last as long; 13NOV cramping & lots of gas but feeling much better;									Y	10/31/1991	11/05/1991	5		PUB	PUB	BP meds	NONE	NONE	~ ()~~~In patient	WA91650	1						1	Abdominal pain; Diarrhoea; Flatulence	FLUX~PFIZER\WYETH~4918147~7+~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036760	12/03/1991	WA	31.0	31		F	11/21/1991	Last PM: chills-fever 102, h/a, muscle aches/pain; fever dec, still h/a, this AM (12 hrs); no GI complaints;									U	11/20/1991	11/20/1991	0	NONE	PUB	PUB	NONE	Denies	Denies	Denies~ ()~~~In patient	WA91653	1						1	Chills; Headache; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~21223~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0036761	12/03/1991	WA	37.0	37		F	11/21/1991	Pt recvd flu vax 7NOV91 230PM & @ 235PM voice turned raspy difficulty breathing, felt bronchial constriction & h/a; 08NOV91 awoke w/t103, unable to move lt arm, secondary pain in joints & swollen lymph nodes (golf ball size); lasted 3 days;									Y	11/07/1991	11/07/1991	0		OTH	PVT	NONE	NONE	drug allergies to PCN, ASA, Erythromycin sensitive to all meds;	~ ()~~~In patient	WA91654	1						1	Arthralgia; Dysphonia; Dyspnoea; Headache; Hypokinesia; Lymphadenopathy; Pyrexia	FLU3~PARKE-DAVIS~04161P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0036763	12/03/1991	CO	54.0	54		M	11/21/1991	Pt recvd vax 30OCT91, started devel pain/tingling in hands & feet approx 1 wk p/vax; progressive weakness.Pt fell X2. Bilateral & symetrical weakness; primarly affected extremities never intubated; dec EMG's; plasmapheresis;			Y		Y					10/30/1991	11/04/1991	5		OTH	PVT	NONE	NONE	hypercholesterol POD, hx of hiatis hernia & rheumatic fever;	~ ()~~~In patient	CO9193	1						1	Asthenia; Hypokinesia; Pain; Paraesthesia	FLUX~PFIZER\WYETH~4918146~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0036764	12/03/1991	CO	47.0	47		M	11/27/1991	Pt recvd flu vax @ 530PM 26NOV91 went to chinese restuarant for dinner right p/vax ate full meal; went to bed @ 9PM awoke 930PM w/severe SOB, cyanosis, inc mucous production; went to ER was told probably MSG rxn-instead of flu vax;				Y					Y	11/26/1991	11/26/1991	0		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Cyanosis; Dyspnoea	FLU3~PARKE-DAVIS~01471P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0036766	12/03/1991	MA	71.0	70		F	11/18/1991	Rash & pruritis @ site of inject occurring w/in 24 hrs post inject; rash intensified spread to arms & legs; Seen by MD on 14NOV91 placed on antihistamines w/improvement;				Y					N	10/22/1991	10/23/1991	1	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MA91004	1						1	Injection site hypersensitivity; Pruritus; Rash	FLUX~PFIZER\WYETH~4918201~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036773	12/03/1991	WA	43.0	43		M	11/25/1991	Pt recvd vax in the AM reports the by late PM (4PM) felt onset of h/a, aching of site of inject, 1-2 hrs of nausea; aching spread to elbows & shoulder; site of inject has 2mm induration; no redness; no edema;										11/22/1991	11/22/1991	0		PUB	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Headache; Injection site mass; Injection site pain; Myalgia; Nausea	FLU3~CONNAUGHT LABORATORIES~1J21108~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0036775	12/03/1991	CA	41.0			F		Localized pain @ inject site on lt arm; pain immediate @ time vax; has remained painful @ same site since; PE neg for deformities;										09/06/1991			NONE	UNK	UNK	Depoestradiol		NA	~ ()~~~In patient		1						1	Injection site pain	FLU3~CONNAUGHT LABORATORIES~1F21201~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0037779	12/04/1991	TX	72.0			M	11/25/1991	Pt recvd flu vax 25OCT89 & on 16NOV89 had complete iridoplegia (pupil dilated) in eye having the cataract surgery; MD thinks flu shot responsible for the adverse event;									N	10/25/1989	11/16/1989	22		OTH	PUB	Not stated		had cataract surgery on 18OCT91 1 wk a/flu shot;	~ ()~~~In patient	914091067	1						1	Mydriasis	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0037781	12/05/1991		56.0			F		Itching without visible hives, blurred vision, sl diaphoresis;									U	11/14/1991				UNK	UNK	Lanoxin, Cardizem		multiple medication allergies-denies egg allergy	~ ()~~~In patient		1						1	Amblyopia; Hyperhidrosis; Pruritus	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0037791	12/06/1991	NY	33.0	33		F	10/28/1991	4 days p/receiving flu vax pt was admitted to hosp 22OCT91 w/t100, severe h/a, and an abnormal LP which showed pleocytosis; cerebrospinal fluid culture was neg; pt recovered uneventfully, w/no neurologic sequelae;					Y	4			Y	10/18/1991			CSF-WBC-28total, PMN 52%, Monos 48%, RBC-1, Protein-27, Glucose-75; Meningococcus-?; strep pyogens-neg; group B strep-neg; E. Coli-neg; CSF culture-neg; VDRL-neg;	PUB	PUB	None	Sxs of URI;	Pt has a hx of mild asthma;	~ ()~~~In patient	891310001J	1						1	Headache; Pleocytosis; Pyrexia	FLUX~PFIZER\WYETH~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0037794	12/06/1991	FL	48.0	48		F	11/13/1991	8NOV91 pt recvd flu shot @ 4PM abrupt onset of bronchial asthma @ 6PM; SOB, wheezing, anterior chest pain w/coughing, sore throat, malaise; duration of rxn approx 10 hrs until 4AM; no treatment;									Y	11/08/1991	11/08/1991	0	NONE	PUB	PUB	NONE	NONE	childhood hayfever, multiple alleergies to dust-mold, plants, trees-Wisconsin; no problem in FL	NONE~ ()~~~In patient	FL91061	1						1	Asthma; Chest pain; Cough; Dyspnoea; Malaise; Pharyngitis	FLU3~PARKE-DAVIS~01581P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0037798	12/06/1991	GA	66.0	66		F	11/12/1991	1NOV91 severe pain on lt side of face & ear; mouth became numb & dropping of lt eye & was dx w/Bell's palsy;				Y						10/23/1991	11/01/1991	9		PUB	UNK	Prednisone x 2 wk;	NONE	NONE	~ ()~~~In patient	GA91315	1						1	Ear pain; Facial palsy; Paraesthesia oral	FLUX~PFIZER\WYETH~4918136~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0037800	12/06/1991	IA	11.0	11		M	11/26/1991	3SEP91 onset of severe rt sided h/a; emesis x 1; 4SEP91 awoke confused, devel generalized sz became hypotensive;	Y	09/04/1991							N	08/27/1991	09/03/1991	7	Autopsy-culture neg; massive cerebral swelling, perivascular lymphocyte cuffing;	PVT	PVT	UNK	NONE	asthma	~ ()~~~In patient	IA910040	1						1	Brain oedema; Confusional state; Convulsion; Headache; Hypotension; Vomiting; Acidosis; Apnoea; Cardiac arrest; Encephalitis; Gastritis haemorrhagic; Grand mal convulsion; Infection	FLUX~PFIZER\WYETH~4918122~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4918122~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Results in Death	Influenza
0037802	12/06/1991	MO	82.0	82		F	11/27/1991	21NOV91 coughing, fever, chills, fatigue, weakness; hospitalized 24NOV91 MD does not feel condition is assoc w/flu shot;					Y				N	11/08/1991	11/21/1991	13	Pneumonia-CXR;	PUB	PUB	Thyroid	NONE	mold, grasses, tres, flower, house dust; thyroid deficiency	NONE~ ()~~~In patient	MO9194	1						1	Asthenia; Chills; Cough; Pyrexia	FLUX~PFIZER\WYETH~4918146~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0037804	12/06/1991	IL	26.0	26		F	11/14/1991	1 1/2 hr p/inject itching fingers & hands then neck & all over fine rash trunk face flushed; treated in ER room; later @ 12 hrs resp wheezing-rx w/steroid;				Y					Y	11/04/1991	11/04/1991	0	NONE	OTH	PVT	NONE	NONE	allergy to PCN & bee stings	NONE~ ()~~~In patient		1						1	Asthma; Pruritus; Rash; Vasodilatation	FLUX~PFIZER\WYETH~4918128~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0037806	12/06/1991	DC	48.0	48		U		Pt c/o sneezing & sinus drainage w/in 1 hrs p/shot administered; also c/o arm aching around flu shot site;										11/06/1991	11/06/1991	0		PUB	PUB		NA	NA	~ ()~~~In patient		1						1	Injection site pain; Rhinitis	FLU3~CONNAUGHT LABORATORIES~1J21108~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0037808	12/09/1991	FL	49.0	49		M	11/26/1991	Shock, metabolic alkalosis, high fever & diarrhea are reported p/recvd flu vax 21NOV91; pt has had cryptococcal meningitis & is HIV positive; Seen in ER t106.7F in shock &  diarrhea admitted to hosp & found to be oliguric;					Y	6			U	11/21/1991	11/21/1991	0		OTH	OTH	AZT (Retrovin), Bactrim, Diflucan	Pt is HIV pos	Pt has had crytococcal meningitis	~ ()~~~In patient	914091068	1						1	Alkalosis; Diarrhoea; Oliguria; Pyrexia; Shock	FLU3~PARKE-DAVIS~~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0037809	12/09/1991	NV				M	12/02/1991	Pt recvd flu vax 7OCT91 & began falling & devel leg numbness 15OCT91 & was admitted to the hosp dx w/GBS; MD felt rxn was unrelated to flu vax;					Y				U	10/07/1991	10/13/1991	6		OTH	PUB	NONE	assume well @ time of vax	NONE	~ ()~~~In patient	CO4030	1						1	Guillain-Barre syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~1J21107~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0037815	12/09/1991	VA	69.0			F	11/14/1991	Pt devel fever, chills, myalgias which progressed to arthritis & synovitis 10 days p/vax; Hospitalized; culture are neg; MD suspects serum sickness, however indirect & direct Coombs test looks nl; pt found to have polyarticular pseudogout;					Y				U		11/01/1991		NA	OTH	OTH	NA	NA	NA	NA~ ()~~~In patient	910216201	1						1	Arthritis; Chills; Myalgia; Pyrexia; Serum sickness; Synovitis	FLU3~LEDERLE LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation	Influenza
0037816	12/09/1991	CA	33.0			F	10/31/1991	Pt recvd vax 30OCT91 & approx 5 hrs p/immun, pt exp abdominal pain, vomiting & a fever of 104; hospitalized; treated w/oral ATB; blood cultures pending;					Y				N	10/30/1991	10/31/1991	1	during hospitalization differential WBc showed 37% BANDS; a recent CBC prior to immun showed no BANDs; blood cultures pending;	PVT	PVT	NA	Healthy	Diabetic	NA~ ()~~~In patient	910208601	1						1	Abdominal pain; Pyrexia; Vomiting	FLU3~LEDERLE LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation	Influenza
0037817	12/09/1991	CT	46.0	46		M	11/19/1991	Pt recvd flu vax on 18NOV91 between 11AM & 2PM; that night pt arrested @ home; EMS were summoned, but pt died; pt suffered an asthma attack; no autopsy was performed; Prior to vax survey form pt didn't indicate allergy to eggs;	Y	11/18/1991	Y						N	11/18/1991	11/18/1991	0		PUB	PUB	UNK	UNK	pt had a hx of chronic, controlled asthma, & was possibly taking meds for this; allergies;	~ ()~~~In patient	891325001J	1						1	Anaphylactoid reaction; Apnoea; Asthma; Bronchitis; Cardiac arrest; Condition aggravated	FLUX~PFIZER\WYETH~4918169~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0037819	12/09/1991	AZ	85.0	85		M	11/27/1991	fx femur lt 8AUG-recovered to walking w/cane & no pain; awoke morning p/flu shot w/sharp pain in leg radiating to knee; needing to use walker now due to pain;				Y					N	10/31/1991	11/01/1991	1	NONE	PUB	UNK	ASA, Dapson	NONE	dermatitis-herpetiform	Sister exp pain past shot also lasting 3 wk only~ ()~~~In Sibling	AZ9128	1						1	Hypokinesia; Pain	FLU3~LEDERLE LABORATORIES~314963~UNK~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0037823	12/09/1991	LA	70.0	70		F	10/31/1991	Started w/numbness of fingers then fever, chills, n/v & urinary incontinence from 230PM 30OCT91 until approx 8AM 31OCT91; worse @ nite;									Y	10/30/1991	10/30/1991	0	NONE	PUB	OTH	NONE	NONE	NONE	NA~ ()~~~In patient	LA911104	1						1	Chills; Nausea; Paraesthesia; Pyrexia; Urinary incontinence; Vomiting	FLU3~CONNAUGHT LABORATORIES~1F21220~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0037827	12/09/1991	MO	28.0	28		F	11/27/1991	P/flu shot pt broke out in red blotchy rash started on arms, chest & entire body; approx 4 hrs later;									Y	10/28/1991	10/28/1991	0		PUB	PUB	Perphen, Valium	HIV positive	HIV positive	NONE~ ()~~~In patient	MO9196	1						1	Rash	FLUX~PFIZER\WYETH~4918146~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037828	12/09/1991	NC	50.0	50		F	11/21/1991	Itching, burning (immediately) hot & red swollen-pain;				Y						11/20/1991	11/20/1991	0		PUB	UNK			Allergic pain meds darvocet-percodan-flexaril etc	~ ()~~~In patient	NC91093	1						1	Oedema; Pain; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~4918145~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~308914~UNK~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0037829	12/09/1991	NC	41.0	41		F	11/27/1991	Pt recvd flu vax 9AM 26NOV91 by 10AM pt felt hot & flushed; rash appeared on face & chest, felt funny, vision blurry, couldn't concentrate, sl hoarseness; returned to clinic 1PM; MD felt pt had mild allergic rxn;				Y					Y	11/26/1991	11/26/1991	0		PUB	PUB		NONE but had had recent surgery;	had hx of asthma-on Theodur	~ ()~~~In patient	NC91094	1						1	Amblyopia; Dysphonia; Hypersensitivity; Malaise; Pyrexia; Rash; Thinking abnormal; Vasodilatation	FLU3~PARKE-DAVIS~01471P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0037830	12/09/1991	NC	64.0	64		M	12/04/1991	Beginning about 3PM 29NOV91 pt exp bad h/a which lasted thru Monday AM, achy all over, chills & fever, & burning w/urination lasted about 2.5 days; started taking kidney med;									Y	11/26/1991	11/29/1991	3	NA	PUB	UNK	Sectal	NONE	Hypertension;allergy to Motrin & PCN	NONE~ ()~~~In patient	NC91095	1						1	Chills; Dysuria; Headache; Myalgia; Pyrexia	FLU3~PARKE-DAVIS~00971P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0037842	12/09/1991	WI	72.0	72		M	11/29/1991	Sudden onset of fever, exacerbation of COPD, inc SOB severe;					Y				U	11/26/1991	11/27/1991	1		PVT	PVT	Pred, Proventil, Azmacort, Nebulizer inhalers	COPD-controlled		~ ()~~~In patient		1						1	Condition aggravated; Dyspnoea; Pyrexia	FLU3~PARKE-DAVIS~01718P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0037843	12/09/1991	IL	82.0	82		M	11/27/1991	Episode of weakness, syncope w/in 45 min of inject, followed by minor confusion;					Y	3			Y	11/19/1991	11/19/1991	0	Atrial fibrillation; Cat Scan of head, carotid dopple neg;	PVT	PUB	Lanoxin, Quinidex	NONE	cardiac arrthymia, ASHD	NONE~ ()~~~In patient		1						1	Asthenia; Atrial fibrillation; Confusional state; Syncope	FLU3~CONNAUGHT LABORATORIES~1F21209~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0037846	12/09/1991	AZ	77.0	77		M	12/03/1991	3 wks post inject pt devel paralysis;	Y		Y				Y		N	10/18/1991	11/14/1991	27	MRI Scan-neg; LP-normal; NCV loss of F waves, slowing;	PVT	PUB	Procardia, Ascriptin	NONE	previous hx brainstomy tia w/flaccid FEB91	~ ()~~~In patient		1						1	Paralysis	FLU3~CONNAUGHT LABORATORIES~1F21209~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0037847	12/09/1991	OH	33.0	32		F	12/02/1991	13OCT91 abdominal pain rt lower, nausea & fever remote hx ovarian cyst; t100.5, 14OCT temp returns to normal; 16OCT oncology consult: leukopenia, fall in neutrophils, flu-like illness or rxn to flu shot;					Y	5			Y	10/08/1991	10/13/1991	5	WBC-2.85, RBC 4.71, Hb 1.29, Hct 37.7, IVP, Pelvic ultrasound, CT abd & pelvis & CXR-WNL	PVT	PVT	Birth control pills	NONE	allergic mercury, metals; MAY90- lt paratoidectomy-CA then radiation neoplasm	~ ()~~~In patient		1						1	Abdominal pain; Cyst; Influenza; Leukopenia; Nausea; Pyrexia	FLUX~PFIZER\WYETH~4918126~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0037852	12/09/1991	NY	5.0	4		F	12/05/1991	Wheezing, urticarial rash that developed about 6 hrs p/being given trivalent influenza vax;				Y					Y	11/01/1991	11/01/1991	0	NONE	PVT	OTH		otitis med	hurler's synd, s/p bone marrow transplant	~ ()~~~In patient		1						1	Asthma; Urticaria	FLU3~PARKE-DAVIS~01481P~1~IM~RL~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0037854	12/09/1991	CA	45.0	45		F	12/02/1991	Onset h/a & general malaise x 2 days; on 3rd day devel herpati lesion on lip; lesions spread to chin, chest, back & extremities; tx Zouirox;				Y					Y	10/15/1991	10/15/1991	0		PUB	PUB	NONE	klenils	hx herpes	~ ()~~~In patient		1						1	Headache; Malaise; Mouth ulceration; Skin ulcer	FLUX~PFIZER\WYETH~4918169~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0037860	12/09/1991	NH	61.0	61		F	12/02/1991	h/a, achiness, 2 days of nausea, loss of appetite, bloating lasting 2 wks; Pt was not seen by MD;									Y	11/08/1991	11/11/1991	3	NONE	OTH	PVT	Synthroid, Capazides	NONE	many allergies, hypertension	pt exp rxn @ 30yrs w/influenza #1 dose;~ ()~~~In patient		1						1	Anorexia; Flatulence; Headache; Myalgia; Nausea	FLUX~PFIZER\WYETH~4918131~UNK~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037861	12/09/1991	NH	53.0	53		F		Pt apparently attributes recent URI (Cough, laryngitis) to flu vax; also w/post nasal drainage; yellow geen sputum & sinus pressure; MD did not feel vax & illness necessarily related;									Y	11/06/1991			NONE	PVT	UNK		NONE	chronic oepatition, angina, hypothyroidism	~ ()~~~In patient		1						1	Cough; Laryngitis; Pharyngitis; Rhinitis	FLU3~PARKE-DAVIS~01471T~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0037864	12/09/1991	MD	32.0	32		F	11/26/1991	4x4 swollen, reddened hot & hard around inject site lt deltoid area painful upon palpation & movement;									Y	11/13/1991	11/15/1991	2	NA	PVT	PVT	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pain; Vasodilatation	FLUX~PFIZER\WYETH~491820~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037865	12/09/1991	FL	73.0	73		M	12/03/1991	Per phone contact w/pt, nausea, cramps, upper respiratory congestion, fever & flu-like sx were reported as persisting for a 2 wk period;									U	11/08/1991	11/08/1991	0	NONE-pt was not hospitalized or seen by MD;	OTH	PUB	Furosemide	NONE	NONE	NA~ ()~~~In patient		1						1	Influenza; Nausea; Pain; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~01271P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0037872	12/11/1991	WV	33.0	33		F	12/02/1991	Approx 25 mins p/inject PC that pt c/o itching & breaking out; had taken benedryl, but no relief; advised to take pt to ER immediately; hives noted on back; face feeling funny & puffy; felt hands swelling;				Y	Y	3			Y	11/21/1991	11/21/1991	0	EKG- D/T tachycardia w/suspren   CBC/FBS/UA-WNL	OTH	PUB	Prenisone &  Zantac	NONE	prev severe reaction to peanut butter; minor reaction to soft-shell crab; systemic reaction to bee stings; allergy to chickens or eggs-sneezes when exposed to feather;	Brother exp rxn in 1981 @ 43 w/flu;~ ()~~~In Sibling	WV9153	1						1	Face oedema; Laryngospasm; Oedema peripheral; Pruritus; Tachycardia; Tongue oedema; Urticaria	FLU3~CONNAUGHT LABORATORIES~1F21200~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0037875	12/11/1991	WV	80.0	80		F	12/03/1991	Pt became anxious & dyspneic; Pt sent to ER & was admitted w/ CHF; has hx of chronic & recurrent CHF;					Y	6			Y	10/25/1991	11/20/1991	26	23NOV CHF-cardiomegaly w/minimal congestive changes; EKG 20NOV PVC, LBBB, lt atrial ab; glucose-20NOV 410	OTH	PUB	Furosemide, Lanoxin, Vasotec NTG, Perestan, Buspou	NONE	ischemic cardiomyopathy, CHF, Alzheimers	NONE~ ()~~~In patient	WV9156	1						1	Anxiety; Bundle branch block; Cardiomegaly; Cardiovascular disorder; Dyspnoea; Hyperglycaemia; Ventricular extrasystoles	FLU3~PARKE-DAVIS~01071P~2~SC~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0037876	12/11/1991	WV	76.0	76		M	12/03/1991	12NOV91 became congested suctioned for lg amt thick mucus & peaches x 2 @ 210 & 545PM, also had emesis 545PM t103.3 R; transferred to Hosp & was admitted w/pneumonia & peripherial vascular disease;					Y	17			Y	10/25/1991	11/12/1991	18	Spinal lap fluid-neg; 27NOV CXR-bil interstitial changes;	OTH	PUB	NONE	NONE	chronic brain synd, COPD, PVD	NONE~ ()~~~In patient	WV9157	1						1	Condition aggravated; Lung disorder; Peripheral vascular disorder; Pneumonia; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~01071P~1~SC~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0037877	12/11/1991	WV	71.0	71		F	12/03/1991	20NOV91 began vomiting @ 130AM x 2 refused to eat through the day; no audible bowel sounds @ 715PM & c/o abd tenderness & admitted to Hosp 20NOV; bowel resection completed due to volvolus of bowel;	Y		Y		Y	13			U	10/25/1991	11/20/1991	26		OTH	PUB	Aldactone, Edecrin, Premarin, Prednisone, Ativan	NONE	Alzheimer's dementia, CHF, hypertension, chronic lymphedeme	NONE~ ()~~~In patient	WV9158	1						1	Abdominal pain; Anorexia; Intestinal obstruction; Vomiting	FLU3~PARKE-DAVIS~01071P~2~SC~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0037878	12/11/1991	WV	73.0	72		M	12/07/1991	Unstable diabetes mellitus; abd pain, n/v, generalized rash; pt hospitalized 3NOV cholecystectomy					Y	12			U	10/25/1991	11/22/1991	28	25OCT FBS-443; 23NOV Glucose-724;	OTH	PUB	Glucotid, Zantac, Senokot	Hyperglycemia	DM, peripheral vas disease, lt AKA	NONE~ ()~~~In patient	WV9159	1						1	Abdominal pain; Condition aggravated; Diabetes mellitus; Hyperglycaemia; Nausea; Rash; Vomiting	FLU3~PARKE-DAVIS~01071P~2~SC~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0037881	12/11/1991	NH				U	12/05/1991	Flu-like sx reported by phone 4 days p/administration; sx lasted 1-2 1/2 wk; pts never contacted office again; no tx; pts never seen during entire duration of illness; ?concurrent viral infection @ time of administration;									Y	11/12/1991	11/16/1991	4	NONE	PVT	PVT		UNK		Same rxn exp by sisters of pt;~ ()~~~In Sibling		1						1	Influenza	FLUX~PFIZER\WYETH~4918119~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037886	12/12/1991	MT	62.0	62		F	11/26/1991	Since receiving flu vax, has had episodes of breaking into a sweat followed by severe h/a & cold chills; when episode starts feel like passing out;				Y						10/19/1991				PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient	MT91014	1						1	Chills; Headache; Hyperhidrosis; Syncope	FLUX~PFIZER\WYETH~4918148~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0037892	12/12/1991	NY	72.0	72		M	12/08/1991	Total body urticarial rash, pruritic, starting 3 days p/inject w/swelling @ inject site;									Y	11/05/1991	11/08/1991	3	2DEC91 normal CBC diff (2EOS) Sed rate 7	PVT	PUB	Prinivil		No known egg allergy	NONE~ ()~~~In patient		1						1	Injection site oedema; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~1F21209~6~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0037893	12/12/1991	NH	60.0	60		M		Coryzal sx, cough, fever 3 wks p/flu shot; Does not feel related to vax;									Y	10/29/1991	11/20/1991	22	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Cough; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~4918109~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037895	12/12/1991	TX	38.0	38		F	12/06/1991	Pt recvd vax 27NOV91 @ 830 & @ 2400 27NOV did not feel well; felt nauseous; 28NOV aching all over, felt as if getting flu, very fatigued, felt like had a temp, back itchy & red, light rash across chest;									N	11/27/1991	11/27/1991	0	NONE	OTH	PVT	NONE	NONE	Demerol-disorientation	NONE~ ()~~~In patient		1						1	Asthenia; Influenza; Malaise; Myalgia; Nausea; Pruritus; Pyrexia; Rash	FLU3~LEDERLE LABORATORIES~312975~1~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0037900	12/13/1991	NY	60.0			F	11/20/1991	1 wk p/receiving flu vax, 60 yo pt presented to hosp w/ PO2 50 & bilateral interstitial pneumonitis; sxs began w/in 24 hrs p/vax; pt had neg gallium scan of lungs & is responding to Prednisone; pt improved & was discharged;					Y				U	11/01/1991			Legionella & ANA-neg; Mycoplasma-neg; Biopsy lung-interstitial pneumonitis; neg gallium scan of lungs;	OTH	OTH	NA	NA	NA	NA~ ()~~~In patient	910219201	1						1	Hypoxia; Pneumonia	FLU3~LEDERLE LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation	Influenza
0037902	12/13/1991	IL	83.0	83		F	11/13/1991	Lt side of face, eye, lip affected (bells palsey);				Y					N	10/29/1991	11/10/1991	12	Cat Scan to r/o;	PUB	PVT	Stiromolectone, Ascriptin, Vitamin	NONE	Hypertensive	~ ()~~~In patient	IL9195	1						1	Facial palsy	FLUX~PFIZER\WYETH~4918143~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0037907	12/13/1991	MO	54.0	54		F	11/01/1991	Fever, chills, sweats lt arm redness, edema, macular rash, warm to touch; took APAP x 2 days;				Y						11/12/1991	11/13/1991	1	BP 120/90	PUB	UNK	Synthroid, Hydrochlorthiazide	NONE	hypertension & hypothyroidism	Pt devel fever & chills; 51 age; flu; 1st dose in series;~ ()~~~In patient		1						1	Chills; Hyperhidrosis; Oedema; Pyrexia; Rash maculo-papular; Vasodilatation	FLUX~PFIZER\WYETH~4918146~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0037909	12/13/1991	HI	31.0			F	11/15/1991	Vomiting @ 630PM on 8NOV91, diarrhea, myalgia, dizziness, general weakness, soreness @ site of inject for 2 days;									Y	11/04/1991	11/08/1991	4	NONE	PUB	PUB		NONE	splenectomy, allergic to sulfa	Pt exp severe swollen arm & fever sick 3 days @ 9 y/o w/Rubella vax dose #1;~ ()~~~In patient		1						1	Asthenia; Diarrhoea; Dizziness; Injection site pain; Myalgia; Vomiting	FLU3~PARKE-DAVIS~1481P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0037910	12/13/1991	NH	81.0	81		F	12/04/1991	Fatigue noted two days p/pt & husband were administered the vax; Reporter was not informed of this rxn until this form was recvd;									Y	10/22/1991	10/24/1991	2	NONE	OTH	PUB	Nolvadex, Synthroid, Timoptic drops	interstitial pulmonary disease	hx of breast cancer; hypothyroidism	~ ()~~~In patient		1						1	Asthenia	FLU3~CONNAUGHT LABORATORIES~1F21216~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0037911	12/13/1991	OH	39.0	39		U		h/a, general malaise lasting 2 days;										11/22/1991	11/23/1991	1		OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Headache; Malaise	FLU3~LEDERLE LABORATORIES~314965~UNK~IM~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0037912	12/13/1991	OH	46.0	46		U		arm very sore-hurt to lift it; painful x 3 days;									Y	12/03/1991	12/04/1991	1		OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Myalgia; Pain	FLU3~PARKE-DAVIS~01071P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0037913	12/13/1991	OH	35.0	35		M	12/09/1991	Fever, generalized malaise, h/a lasted 2 days;									Y	11/12/1991	11/13/1991	1	NA	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Headache; Malaise; Pyrexia	FLU3~PARKE-DAVIS~00771P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0037914	12/13/1991	PA	66.0	66		M	12/10/1991	Sore throat, fever, ears clogged, general malaise; to continue w/ASA, fluids, rest-sx not severe enough to require office visit;									Y	09/13/1991	09/14/1991	1		PVT	PUB		NONE		~ ()~~~In patient		1						1	Ear disorder; Malaise; Pharyngitis; Pyrexia; Asthenia; Lung disorder; Myalgia; Neuropathy; Pain; Paraesthesia; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~21209~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~1F21209~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0036611	12/16/1991	MO	56.0	56		F	11/15/1991	Pt devel GBS p/receiving flu vax; consulting neurologist was uncertain that this adverse event was related to the flu vax, since pt had two recent pts w/GBS who were not vaxed;					Y	36			U	10/31/1991	11/08/1991	8		PUB	PUB	UNK	UNK		~ ()~~~In patient	891325002J	1						2	Dysphagia; Guillain-Barre syndrome; Hypokinesia; Myalgia; Myasthenic syndrome; Paraesthesia; Vomiting; Asthenia; CSF test abnormal; Facial palsy; Guillain-Barre syndrome; Hyporeflexia; Myalgia; Paraesthesia; Quadriplegia	FLUX~PFIZER\WYETH~4918146~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4918146~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0037800	12/16/1991	WI	11.0	11		M	11/15/1991	Pt recvd flu vax 27AUG91; 03SEP91 pt noted to have h/a, acting strangely & was taken to ER, where sz ensued; also lethargic, unrespoonsive, color became poor; BP dropped; bright red blood was noted from rectum; encephalitis;	Y	09/04/1991			Y				N	08/27/1991	09/03/1991	7	4SEP91 WBC-13,600	PVT	OTH	UNK	UNK			891326001J	1						2	Brain oedema; Confusional state; Convulsion; Headache; Hypotension; Vomiting; Acidosis; Apnoea; Cardiac arrest; Encephalitis; Gastritis haemorrhagic; Grand mal convulsion; Infection	FLUX~PFIZER\WYETH~4918122~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4918122~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Results in Death	Influenza
0037917	12/16/1991	MD	71.0			M	09/19/1991	Pt w/a long-standing hx of severe hearing impairment, claimed exp inc hearing loss 16 days p/recvd flu vax; On 24SEP91 pt c/o vertigo & poss Meniere's disease;								Y	N	09/03/1991	09/19/1991	16		PVT	PVT	Salutensin, Theodur, Ventolin, Azmacort, Xanax;	NONE	pt has hx of hearing loss (wears 2 hearing aids), dizziness, hypertension, chronic obstructive pulmonary disease, & benign prostatic;	~ ()~~~In patient	891291023L	1						1	Condition aggravated; Deafness; Vertigo; Vestibular disorder	FLUX~PFIZER\WYETH~4818127~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0037918	12/16/1991	WI	85.0			F	12/10/1991	Peripheral neuropathy reported in pt who recvd flu vax 12NOV91; pt admitted to hosp w/lower extremity weakness; discovered to have adenocarcinoma of lung; MD wonders if lower extremity weakness is part of a neoplastic synd re: CA or ADR vax					Y				N	11/12/1991	11/13/1991	1	CXR-lung mass	PVT	PVT	UNK			~ ()~~~In patient	914091069	1						1	Asthenia; Lung neoplasm malignant; Neuropathy peripheral	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0037922	12/16/1991	CA	83.0	83		F	11/08/1991	P/eating lunch, approx 2 hrs p/ 12, started to feel weak, vision w/black spots; that night, devel chilling, myalgia, no fever; over next day, devel productive cough & h/a; stayed in bed until 7NOV, contacted MD & visited MD on 7NOV;				Y					Y	11/04/1991	11/04/1991	0	NONE	PUB	PUB	Dyazide, Phenobarbital	NONE	hypertension	NONE~ ()~~~In patient	CA91146	1						1	Asthenia; Chills; Cough; Headache; Myalgia; Visual disturbance	FLUX~PFIZER\WYETH~4918170~5~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0037924	12/16/1991	CA	65.0	65		M	12/04/1991	sx started 4 hrs p/immun; pt noticed h/a, flushing @ first & took APAP; awoke in middle of night w/shaking, chills, dizziness, & unsteady on feet, weakness, fatigue & sl nausea sx cont x 24 hrs;									Y	10/30/1991	10/30/1991	0	NONE	PUB	PUB	NONE	NONE	hayfever	pt exp mild discomfort @ 40 w/flu~ ()~~~In patient	CA91148	1						1	Asthenia; Chills; Dizziness; Headache; Nausea; Tremor; Vasodilatation	FLUX~PFIZER\WYETH~21918169~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~302905~1~SC~RA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~0M21075~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0037925	12/16/1991	CA	69.0	69		F	11/13/1991	Sunburn like rash on shoulders & posterior portion of upper arms; itching inside of ears, arms & rear of hands; burning sensation in the nose; rhinitis, watery eyes, under the skin bumps; appeared 4 hrs p/flu vax & lasted approx 1 1/2 hr;									Y	11/12/1991	11/12/1991	0	NONE	PUB	PUB	Tenorim	NONE	PCN, Iodine summer allergies, inc BP	NONE~ ()~~~In patient	CA91149	1						1	Lacrimal disorder; Pain; Pruritus; Rash; Rhinitis	FLUX~PFIZER\WYETH~4918169~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037926	12/16/1991	CA	65.0	65		M	11/08/1991	Pt recvd flu vax on 24OCT91 & presented to ER on 3NOV91 w/ a 4 day hx of fever, lower extremity weakness; generalized weakness & questionable seizure activity;				Y	Y	15				10/24/1991	10/30/1991	6	CSF-Scantgroup; Staph Aureus bld-steph aureus; CSF-WBC-820, RBC 107 Protein 268, FR stain 0;	PUB	PUB		NONE	Chronic renal failure; septic hip	~ ()~~~In patient	CA91150	1						1	Asthenia; Convulsion; Infection; Pyrexia	FLUX~PFIZER\WYETH~4918169~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0037927	12/16/1991	CA	60.0	60		F		Pt recvd flu shot 4NOV & rash started on arms, spread to legs & abdomen, by 7NOV91 & 8NOV91 itchy, dry, red tiny bumps, became mottled;									Y	11/04/1991	11/06/1991	2	NONE	PUB	PVT	allergy shot 5NOV91, Estrogen, Amen, Thyroid, synthroid, MVI-Cytomel	NONE	asthma, hayfever	~ ()~~~In patient	CA91151	1						1	Dry skin; Pruritus; Rash; Skin discolouration	FLUX~PFIZER\WYETH~4918154~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~312944~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0037929	12/16/1991	CA	71.0	71		F	11/06/1991	Erythema of lt deltoid area approx 3 x 5 began @ site of inject 1 wk p/inject;									Y	10/28/1991	11/04/1991	7		UNK	PUB				~ ()~~~In patient	CA91153	1						1	Injection site hypersensitivity	FLUX~PFIZER\WYETH~4918169~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~302905~1~IM~RA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~0M21075~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0037936	12/16/1991	CA	31.0	31		F	11/08/1991	Pt reports redness & warmth in area of lt arm where vaccinated & wheezing beginning 2 hrs p/inject lasting 3 hrs;									Y	10/24/1991	10/24/1991	0	NA	UNK	PUB	NONE	NKA	asthma	~ ()~~~In patient	CA91160	1						1	Asthma; Injection site hypersensitivity; Vasodilatation	FLUX~PFIZER\WYETH~4918169~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037937	12/16/1991	CA	79.0	79		F	11/21/1991	Onset general malaise w/t100.4, sore throat productive cough;dx by MD w/bronchitis; given Ceftin x 10 days;				Y					Y	11/08/1991	11/17/1991	9		PUB	PUB	Nitro transderm, thyroid	Denies	cardiac & low thyroid	~ ()~~~In patient	CA91161	1						1	Bronchitis; Cough; Malaise; Pharyngitis; Pyrexia	FLUX~PFIZER\WYETH~4918169~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0037938	12/16/1991	CA	49.0	49		M	11/14/1991	Approx 6 hrs p/receiving flu shot devel sl pain on outside of lt ear & sl difficulty moving lt side of face; next morning lt side of face partially paralyzed down to about jaw line; dx Bell's Palsy by MD;				Y					N	11/12/1991	11/12/1991	0		PUB	PUB	NONE	Denies	NONE	~ ()~~~In patient	CA91162	1						1	Ear pain; Facial palsy; Hypokinesia	FLUX~PFIZER\WYETH~4918169~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0037939	12/16/1991	CA	60.0	60		F	11/21/1991	SOB, weakness w/nausea; cough & wheezing;									Y	11/04/1991	11/05/1991	1		PUB	PUB	Estrogen, Thyroid, Antihistamine for cough		persistent cough; viral infect	~ ()~~~In patient	CA91163	1						1	Asthenia; Asthma; Cough; Dyspnoea; Nausea	FLUX~PFIZER\WYETH~4918169~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037940	12/16/1991	CA	88.0	88		F	11/25/1991	Sore throat, fever, h/a, & cough, laryngitis; 2DEC91 fully recovered;									Y	11/21/1991	11/23/1991	2		PUB	PUB	Hypertensive cardiac  ATB	NONE	chronic bladder infection; arthritis; ?	~ ()~~~In patient	CA91164	1						1	Cough; Headache; Laryngitis; Pharyngitis; Pyrexia	FLUX~PFIZER\WYETH~4918169~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037941	12/16/1991	CA	70.0	70		F	11/27/1991	Onset w/sore erythematous inject site; devel sore throat, h/a, aching muscles x approx 7 days;									Y	11/12/1991	11/13/1991	1		PUB	PUB	Darvocet, Thiocet, thyroid, Premarin	Denies	Chronic fatigue synd	~ ()~~~In patient	CA91165	1						1	Headache; Injection site hypersensitivity; Injection site pain; Myalgia; Pharyngitis	FLUX~PFIZER\WYETH~4918169~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037942	12/16/1991	CA	69.0	69		M	11/27/1991	Approx 36 hrs p/receiving flu shot; woke up w/chills & then diaphoretic; sx lasted a couple of hrs;									Y	11/04/1991	11/05/1991	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	CA91166	1						1	Chills; Hyperhidrosis	FLUX~PFIZER\WYETH~4918169~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037943	12/16/1991	CA	68.0	68		F	11/18/1991	Sore throat, h/a, URI, general malaise persistent cough;									Y	11/05/1991	11/16/1991	11	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	CA91167	1						1	Cough; Headache; Malaise; Pharyngitis	FLUX~PFIZER\WYETH~4918169~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037944	12/16/1991	CA	2.0	2	.3	F	11/18/1991	Onset w/cough & sneezing; t101 x 2 days; Seen by MD who prescribed meds;				Y					Y	11/13/1991	11/14/1991	1		PUB	PUB	NONE	Denies	Household contact & chronic ?	~ ()~~~In patient	CA91168	1						1	Cough; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~4918169~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0037945	12/16/1991	CA	17.0	17		F	11/22/1991	22NOV feels hot; 25NOV felt warm & sl nauseated x approx 2 hrs;									Y	11/21/1991	11/22/1991	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	CA91169	1						1	Nausea; Pyrexia	FLUX~PFIZER\WYETH~4918169~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037946	12/16/1991	CA	48.0	48		M	11/22/1991	Sl fever; general malaise; generalized muscle pain w/sl nausea; devel severe abdominal cramps w/t105; dx w/viral gastroenteritis;				Y					Y	11/21/1991	11/21/1991	0	CXR	PUB	PUB	Vasotec & many other	Denies	hypertension	~ ()~~~In patient	CA91170	1						1	Abdominal pain; Gastroenteritis; Malaise; Myalgia; Nausea; Pyrexia	FLUX~PFIZER\WYETH~4918169~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0037947	12/16/1991	CA	46.0	46		M	11/22/1991	Onset 18NOV w/URI, sore throat, asthmatic MD prescribed E Mycin				Y					Y	11/11/1991	11/18/1991	7	NONE	PUB	PUB	Asthma Cort, Uniphil, Zestel, Desyel	Denies	Asthmatic; hypertension; depression	~ ()~~~In patient	CA91171	1						1	Asthma; Pharyngitis	FLUX~PFIZER\WYETH~4918169~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0037948	12/16/1991	CA	36.0	36		F	11/20/1991	RN noticed immediate swelling upon giving inject; no other sx, no redness, soreness or pruritis; swelling diminished & gone w/in 36 hrs;									Y	11/19/1991	11/19/1991	0	NONE	PUB	PUB	Esterol	NONE	NONE	~ ()~~~In patient	CA91172	1						1	Oedema	FLUX~PFIZER\WYETH~4918169~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037949	12/16/1991	CA	51.0	51		F	11/19/1991	Pt states devel sl swelling @ site of inject which lasted approx 15 mins; denies pain or redness; completely recovered;									Y	11/19/1991	11/19/1991	0	NONE	PUB	PUB	Theodur, Adivon	Denies	NONE	~ ()~~~In patient	CA91173	1						1	Injection site oedema	FLUX~PFIZER\WYETH~4918169~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037950	12/16/1991	CA	68.0	68		F	11/18/1991	c/o sore throat, cough w/URI & fever;				Y					Y	11/02/1991	11/09/1991	7		PUB	PUB	Thyroid, Aldacare	Denies		~ ()~~~In patient	CA91174	1						1	Cough; Pharyngitis; Pyrexia	FLUX~PFIZER\WYETH~4918169~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0037951	12/16/1991	CA	72.0	72		M	11/18/1991	sore throat, cough w/URI & fever; h/a, general malaise;				Y					Y	11/02/1991	11/09/1991	7		PUB	PUB	Hypertension med	NONE	hypertension	~ ()~~~In patient	CA91175	1						1	Cough; Headache; Malaise; Pharyngitis; Pyrexia	FLUX~PFIZER\WYETH~4918169~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0037952	12/16/1991	CA	75.0	75		M	11/13/1991	C/o fever 101 w/sl tenderness @ inject site; fever became progressively higher; fluid detected in lungs; admitted & released p/ 3 days; dx uncertain;					Y	3			Y	11/08/1991	11/13/1991	5	Blood cultures-neg; Echocardigram;	PUB	PUB	Blackadrene	Denies	NONE	~ ()~~~In patient	CA91176	1						1	Injection site pain; Lung disorder; Pyrexia	FLUX~PFIZER\WYETH~4918169~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0037953	12/16/1991	CA	61.0	60		F	11/12/1991	30OCT pain in neck & shoulder; cramping in lt arm;									Y	10/28/1991	10/30/1991	2		PUB	PUB	Dieuretic & many other meds	cirrhosis of liver	cirrhosis of liver	~ ()~~~In patient	CA91177	1						1	Hypertonia; Neck pain; Pain	FLUX~PFIZER\WYETH~4918169~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037954	12/16/1991	CA	65.0	65		M	11/12/1991	7 days p/flu shot pt devel body aches & general malaise w/sore throat; cramping feeling in muscle of lt arm;				Y					Y	10/28/1991	11/05/1991	8		PUB	PUB	Theodore, K & many other meds	CA in throat	CA in throat	~ ()~~~In patient	CA91178	1						1	Hypertonia; Malaise; Myalgia; Pharyngitis	FLUX~PFIZER\WYETH~4918169~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0037955	12/16/1991	CA	74.0	74		F	11/12/1991	inflammed, purtitic area around inject site x approx  48 hrs;									Y	11/08/1991	11/11/1991	3	NONE	PUB	PUB	Denies	NONE	NONE	~ ()~~~In patient	CA91179	1						1	Injection site inflammation; Pruritus	FLUX~PFIZER\WYETH~4918169~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037956	12/16/1991	CA	64.0	64		F	11/07/1991	Onset w/sore throat, chill, general malaise, t101;									Y	10/28/1991	11/02/1991	5		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	CA91180	1						1	Chills; Malaise; Pharyngitis; Pyrexia	FLUX~PFIZER\WYETH~4918169~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037959	12/16/1991	CA	64.0	64		M	12/05/1991	Pt recvd vax on 2DEC91 & on 3DEC rash started aobut 3-4 below inject site; 2 wide rash that itches; rash runs down arm & branched @ elbow & continued on inner aspect of arm also; red welts on inner arm; MD stated minor allergic rxn;									Y	12/02/1991	12/03/1991	1	NONE	PUB	PUB	Valium, APAP w/Codeine, Demerol syrup, Diphenlydramine	NONE	ankylosis spondylolysis	NONE~ ()~~~In patient	CA91183	1						1	Hypersensitivity; Pruritus; Rash; Urticaria	FLUX~PFIZER\WYETH~4918170~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037960	12/16/1991	CO	39.0	39		F	11/22/1991	rt leg pain, weakness, numbness; lt leg numbness; dx transverse myelitis;					Y		Y		N	10/24/1991	11/05/1991	12	MRI, Myelogram w/ CT cuts;	PUB	PVT		NONE	NONE	~ ()~~~In patient	CO9192	1						1	Asthenia; Myelitis; Pain; Paraesthesia	FLU3~PARKE-DAVIS~01381P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0037968	12/16/1991	MS	55.0	55		F	11/15/1991	Egg size red area @ site of inject, swelling in neck on side inject was given; joint pain on side inject given; dull h/a; relieved by analgesics but returns;									Y	11/08/1991	11/10/1991	2	NONE	PUB	PUB		NONE	hx of hypertension, arthritis hip & arm	NONE~ ()~~~In patient	MS9152	1						1	Arthralgia; Headache; Injection site hypersensitivity; Oedema	FLUX~PFIZER\WYETH~4918153~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037969	12/16/1991	MS	39.0	39		F	11/18/1991	Pt recvd flu shot on 14NOV91 & on the AM of 15NOV91 noticed red places on rt chest & inner thighs which progressed to arms, all over chest & back & 2 days later to hands & feet; Seen by MD 16NOV91; rx for meds, 18NOV91 rash not better;				Y					Y	11/14/1991	11/15/1991	1	2DEC91 pt call & stated has seen a dermatologist & had the lesions biopsied & that MD stated rash was caused by the flu shot; as of 2DEC91 recovered;	PUB	PUB	Elavil & Calan	NONE	Migraine h/a	~ ()~~~In patient	MS9153	1						1	Rash	FLUX~PFIZER\WYETH~4918148~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0037972	12/16/1991	OK	57.0	57		F	11/27/1991	Pt recvd vax 26NOV91 & reported chills & fever all night, sore lt arm, redness around inject site, & red streaks running from inject site; also stated pain in lt arm, radiating to lt breast; went to MD 26NOV91, rx for meds;									Y	11/26/1991	11/27/1991	1	NONE	PUB	PUB	UNK	NONE	NONE	NONE~ ()~~~In patient	OK9179	1						1	Chills; Injection site hypersensitivity; Myalgia; Pain; Pyrexia; Skin striae	FLUX~PFIZER\WYETH~4918169~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~312943~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0037977	12/16/1991	MN	32.0	32		F		Elevated liver enzymes, nausea;									Y	10/29/1991	11/02/1991	4	Bilirubin, total-1.6;	PUB	OTH	NONE		NONE	NONE~ ()~~~In patient		1						1	Hepatic function abnormal; Nausea	FLUX~PFIZER\WYETH~4918143~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037980	12/16/1991	VA	47.0	47		F	12/10/1991	felt heavy almost immediately p/receivng inject; 2 to 3 hrs later felt feverish, achey & exp congestion in throat & lungs, cough, chills;									Y	12/09/1991	12/09/1991	0	NONE	PUB	OTH	Inderal	NONE	allergic to codiene & darvon	~ ()~~~In patient	VA91104	1						1	Chills; Cough; Lung disorder; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~1F21216~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0037984	12/16/1991	OR	36.0	36		F	12/05/1991	Immediately p/receiving vax pt became dizzy w/inc resp rate which lasted for 2 days; pt had a low grade fever, achiness, joint pain & extreme fatigue for 2.5 wks; c/o vision changes;									U	11/14/1991	11/14/1991	0	NONE	PUB	PVT	NONE	NONE	allergies to codeine/yeast/sugar	NONE~ ()~~~In patient		1						1	Arthralgia; Asthenia; Dizziness; Hyperventilation; Myalgia; Pyrexia; Visual disturbance	FLUX~PFIZER\WYETH~4918147~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037987	12/16/1991	TX	50.0	50		U	11/27/1991	Dx by MD 18NOV91 bilateral brachial plexitis (L>R), probably post vax; 48 hrs post vax c/o nausea, malaise; 96 hrs post vax upper ext weakness (L>R) w/painful fasciculations; difficulty fine motor control, myalgias, arthralgias, back pain;				Y					Y	11/05/1991	11/07/1991	2	18NOV Exam slight wks lt trapezius; slight hyporeflexia lt triceps; 19NOV91 EMG-WNL; serum protein electrophoresis-WNL Sed rate-0; CBC-plts-107,000; WBC 4400w/nl diff;	MIL	MIL	ASA, multivitamin	NONE	NONE	~ ()~~~In patient		1						1	Arthralgia; Asthenia; Malaise; Movement disorder; Muscle twitching; Myalgia; Neuritis; Thrombocytopenia	FLU3~CONNAUGHT LABORATORIES~1J21129~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0037994	12/16/1991	NH	73.0	73		F		14OCT91 pt called c/o nausea, instructed phenergan suppository; 305PM pt called stated vomited p/taking phenergan suppository; instructed go to ER for eval of vomiting & c/o leg cramps;				Y						10/08/1991				UNK	UNK				~ ()~~~In patient		1						1	Muscle spasms; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~1F21216~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0038013	12/17/1991	MO	40.0	40		F	11/27/1990	Temp mesaured to be 100.0F; local rxn; joint pain; paresthesias; as of 9OCT91 pt is partly recovered; when pressure applied to inject site, pt reports soreness;				Y					Y	10/26/1990	10/27/1990	1		OTH	PUB				~ ()~~~In patient		1						1	Arthralgia; Injection site pain; Paraesthesia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0F11222~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0038023	12/19/1991	NY	57.0	57		M	11/08/1991	Flu sx-aching, chills, t103 also had bladder infect;				Y					Y	10/23/1991	10/24/1991	1		PUB	PUB				~ ()~~~In patient	TN91211	1						1	Chills; Cystitis; Influenza; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~1F21216~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0038024	12/19/1991	TN	53.0	53		F	11/13/1991	Malaise, flu sx shoulders, chest & lungs hurt; sore all over;				Y						10/29/1991	11/06/1991	8		PUB	PUB				~ ()~~~In patient	TN91212	1						1	Chest pain; Influenza; Malaise; Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~1F21216~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0038025	12/19/1991	TN	64.0	64		F	11/06/1991	Head, rt arm rt leg began jerking uncontrollably @ aobut 7PM pt states threw up about 2 hrs later for about 10min; then everything was okay; Called clinic was told to take APAP;									Y	11/05/1991	11/05/1991	0		PUB	PUB			High cholesterol on Lopid & Rheumatism on Pred;	~ ()~~~In patient	TN91213	1						1	Muscle twitching; Vomiting	FLU3~CONNAUGHT LABORATORIES~1F21220~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0038032	12/19/1991	TN	66.0	66		F	11/25/1991	Double pneumonia, pleurisy;				Y					Y	11/12/1991	11/13/1991	1		PUB	PUB				~ ()~~~In patient	TN91220	1						1	Pleural disorder; Pneumonia	FLU3~CONNAUGHT LABORATORIES~1F21215~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0038035	12/19/1991	TN	74.0	74		M	11/25/1991	Pt recd vax @ clinic 15NOV91 became ill on 17NOV91 w/fever 102 & confusion taken to ER admitted while hospitalized discovered urinary tract tumor; p/4 days hospitalized discharged by MD; dx encephalopathy/post influenza vax-encephalitis;					Y	4			Y	11/15/1991	11/17/1991	2	CBC showed WBC 15,000; UA showed hematuria-LP-neg;	PUB	PUB	UNK	denied any illness	prev hx urinary tract problems/penial implant x 2 yrs;	~ ()~~~In patient	TN91223	1						1	Confusional state; Encephalitis; Encephalopathy; Haematuria; Leukocytosis; Malaise; Pyrexia; Urinary tract disorder	FLU3~CONNAUGHT LABORATORIES~1F21216~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0038039	12/19/1991	TX	25.0	25		M	10/15/1991	Fever blisters, chills, fever, aching vomiting, leg cramps-flu like sx;				Y					U	10/07/1991	10/07/1991	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	TX91127	1						1	Chills; Influenza; Mouth ulceration; Muscle spasms; Myalgia; Pyrexia; Vomiting	FLUX~PFIZER\WYETH~4918169~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038044	12/19/1991	TX	70.0	69		M	10/18/1991	Red irritation & swelling @ inject site; red, swollen urticaria w/itching from lt deltoid to wrist;									Y	10/15/1991	10/15/1991	0	NONE	PUB	PUB	Pred, testrone	NONE	pituitary damage due to tumor removal	NONE~ ()~~~In patient	TX91132	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Urticaria	FLUX~PFIZER\WYETH~4918174~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~287908~1~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0038057	12/19/1991	TX	74.0	74		F	11/11/1991	1245 on 8NOV91 pt c/o pain in rt arm @ inject site & radiating down to fingers; area red swollen & raw to touch; c/o pain w/movement;									Y	11/08/1991	11/08/1991	0		PUB	PUB		NONE	NKA	~ ()~~~In patient	TX91145	1						1	Injection site hypersensitivity; Injection site pain; Oedema; Pain; Vasodilatation	FLUX~PFIZER\WYETH~4918174~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0038060	12/19/1991	TX	64.0	64		M	11/25/1991	On day vax recvd pt became very achy, feverish, & sick w/severe h/a & neck ache; had bad dreams 2nd day upset stomach & low grade fever; 3rd day low grade fever & joint ache;									Y	11/22/1991	11/22/1991	0		PUB	PUB	Methyldopa, Lopid, Dypericumal	NONE	bypass surgery	~ ()~~~In patient	TX91148	1						1	Abnormal dreams; Arthralgia; Dyspepsia; Headache; Malaise; Myalgia; Neck pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~1F21223~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~308913~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0038064	12/19/1991	TX	11.0	11		F	11/01/1991	Pt was given flu vax & began c/o pain @ site down to the entire lt arm; 3 min later, entire lt arm went numb; Pt began crying & hyperventilating;									Y	10/30/1991	10/30/1991	0	NONE	PUB	PUB		NONE	NONE	NONE~ ()~~~In patient	TX91152	1						1	Agitation; Hyperventilation; Injection site pain; Pain; Paraesthesia	FLUX~PFIZER\WYETH~4918174~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0038080	12/20/1991	NY				U		Pt exp blindness p/receiving an influenza vax; This case is in litigation; No other info is now available; Add'l info will be requested from the MD;								Y	U		12/01/1991		UNK	UNK	UNK	UNK	UNK	UNK	~ ()~~~In patient	1291017	1						1	Blindness	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0038084	12/20/1991	MO	65.0	65		F	12/06/1991	3 days p/receiving influenza immun, devel, sore throat, runny nose, cough (severe), off work a couple of days, felt sick for a couple of wks afterward;									Y	11/05/1991	11/08/1991	3		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MO9199	1						1	Cough; Malaise; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4918146~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0038085	12/20/1991	MO	73.0	73		M	12/11/1991	8NOV91 began coughing productively (green & yellow sputum);11NOV91 @ MDs office for cough; temp was elevated inc 100 admitted directly to hosp; was on med/surg floor; exp drug induced hallucinations; dx emphysema & chronic bronchitis;					Y	8			U	11/04/1991	11/08/1991	4	None revealed by hospital or physicians office	PUB	PUB	Theodur, Quine, Organibin, Calciumsupplement;	Known chronic COPD;	COPD, emphysema	NA~ ()~~~In patient	MO91100	1						1	Bronchitis; Cough; Hallucination; Productive cough; Pyrexia	FLUX~PFIZER\WYETH~4918146~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0037914	12/23/1991	PA	66.0	66		M	11/19/1991	t102, weakness, h/a, severe muscle pain in arms & especially in legs, chest congestion, cough; sx continued for 2-3 wks; approx 4 wks p/vax, tingling, numbness & pain in fingers & toes, hands & feet, occasionally the full length of extremi;				Y					N	09/03/1991	09/03/1991	0	UNK	PVT	PUB		NONE		~ ()~~~In patient	PA91304	1						2	Ear disorder; Malaise; Pharyngitis; Pyrexia; Asthenia; Lung disorder; Myalgia; Neuropathy; Pain; Paraesthesia; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~21209~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~1F21209~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0038091	12/23/1991	FL	35.0			M	11/26/1991	Approx 1wk prior to receiving flu vax pt exp flu-like sx; approx 10 days to two wks p/receiving the flu vax pt again again began exp flu-like sx which progressed to total paralysis;								Y	U	10/17/1989				OTH	OTH	UNK	flu-like sx 1wk prior to vax	pt may have had a prior hx of GBS and/or polio; allegedly, was unable to ambulate from age 13;	~ ()~~~In patient	891344001H	1						1	Influenza; Paralysis	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0038092	12/23/1991	MT	44.0	44		F	11/26/1991	Pt devel GBS 5 days p/receiving flu vax; additional info has been requested;			Y	Y	Y	21		Y	N	10/31/1991	11/05/1991	5		PUB	PUB	UNK	UNK	UNK	~ ()~~~In patient	891331002J	1						1	Guillain-Barre syndrome; Myasthenic syndrome; Peroneal nerve palsy	FLUX~PFIZER\WYETH~4918147~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0038094	12/23/1991	AZ	70.0	70		F	12/11/1991	Fever, sweats; hospitalized in S. Africa 15NOV-22NOV; dx pneumonia; no cough;					Y				Y	11/07/1991	12/11/1991	34	? done in s. Africa;	PUB	UNK	Fansidor	NONE	NONE	NONE~ ()~~~In patient	AZ9129	1						1	Hyperhidrosis; Pneumonia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~1F21218~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0038095	12/23/1991	FL	69.0	69		F	11/21/1991	8NOV91 reported felt chills, sore throat, fever; pt was instructed to see MD if it persisted past 48 hrs; 2NOV91 pt called reporting had gotten the flu from flu shot on 6NOV91; c/o sore throat, chills, fever 102-103 severe lung infection									Y	11/06/1991	11/06/1991	0	NONE	PUB	PUB	Just finished Noroxin & PCN	recently recovered form UTI	NONE	~ ()~~~In patient	FL91063	1						1	Asthenia; Chills; Infection; Influenza; Lung disorder; Pharyngitis; Pyrexia	FLU3~PARKE-DAVIS~04161P~3~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0038096	12/23/1991	FL	72.0	72		M	11/18/1991	c/o of sore throat, aches, fever 100+ for over a wk; seen by MD 7NOV91; MD ordered ATB as of 15NOV91; pt improved but not quite over it;				Y					Y	10/31/1991	11/01/1991	1	NONE	PUB	PUB		NONE		NONE~ ()~~~In patient	FL91064	1						1	Myalgia; Pharyngitis; Pyrexia	FLU3~PARKE-DAVIS~01481P~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0038097	12/23/1991	FL	64.0	64		F	11/18/1991	c/o sore throat, aches, fever 100.8 for over a wk; Seen by MD 7NOV91; MD ordered ATB; as of 15NOV91 pt improved but not quite over it;				Y					Y	10/31/1991	11/01/1991	1	NONE	PUB	PUB		NONE		~ ()~~~In patient	FL91065	1						1	Myalgia; Pharyngitis; Pyrexia	FLU3~PARKE-DAVIS~01481P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0038114	12/23/1991	OH	67.0	67		F	12/06/1991	Guillian Barre Synd				Y	Y		Y	Y	Y	11/22/1991	11/30/1991	8	Spinal fluid protein elvated to 115 mg%,  Compatible w/ diagnosis	PVT	UNK	Trinsicon Q day	none	none	~ ()~~~In patient		1						1	CSF test abnormal; Guillain-Barre syndrome	FLU3~PARKE-DAVIS~01481P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation,Disabling	Influenza
0038122	12/23/1991	WI	15.0	15		F	12/19/1991	Severe redness swelling in arm where influenza vax given. Resolved p/72 hrs.				Y					Y	11/07/1991	11/07/1991	0	no hx of egg allergy	PVT	PVT				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~IF21213~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0038124	12/23/1991	NH	78.0	78		F	12/02/1991	Rec'd vac on 6Nov .Went to ER /w resp difficulty.Went back to ER 9Nov saw MD X3. MD reported not a vax rxn. Rx Buspar. Still having slight resp difficulty on 12Nov91.				Y					U	11/06/1991	11/07/1991	1		PUB	UNK		none	none	~ ()~~~In patient		1						1	Dyspnoea	FLUX~PFIZER\WYETH~4918134~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038125	12/23/1991	AZ	60.0	60		F	12/04/1991	While recving flu vaxs felt gushing sensation from lt to rt chest & front &back neck.Chest felt like it was being filled w/H2O from a hose.Heat occurred in rt temple-size of thumb tack.Sx cont over 4 days.Tongue/lip swelled twisted to lt				Y					U	11/20/1991	11/20/1991	0	26Nov91 Audio-NR (R)	PUB	UNK	1 a day vit w/Fe.	none	diabetes-diet controlled	became ill w/flu like sxs p/receiving a flu vax; date unknown;~ ()~~~In patient	AZ9205	1						1	Chest pain; Face oedema; Facial palsy; Tongue oedema; Vasodilatation	FLU3~LEDERLE LABORATORIES~314963~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0038126	12/23/1991	MN	33.0	33		F	12/16/1991	25Nov91 indicated pt had large oblong area of erythema the size of 50 cent piece or larger, hardness & reddness of area.									Y	11/21/1991	11/21/1991	0		MIL	PVT	Ventolin PRN	none	asthma-foods-eczema	erythema to Mantoux solns~ ()~~~In patient		1						1	Rash; Skin nodule; Vasodilatation	FLUX~PFIZER\WYETH~4918136~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0038128	12/23/1991	NH	64.0	64		F	12/12/1991	Rec'd vax day before trip to FL.2-3 wks into trip started /w a cough which persisted 3 wks &bad enough to make pt want to lie down.Cough meds helped break up cough.FL extremely warm.Came home/p Thanksgiving-feels tired.Due to travel or ill?									Y	10/10/1991	10/24/1991	14	none	PUB	UNK	none	none	none	~ ()~~~In patient		1						1	Asthenia; Cough	FLU3~CONNAUGHT LABORATORIES~1F21216~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0038135	12/23/1991	NY	32.0	32		M	12/19/1991	Pt received vaccine 16Oct91, devel Bell's Palsy 20Oct91 lt, palsy worsened 20Oct->24Oct. Palsy stable 24Oct->28Oct. Palsy improved 28Oct->present.									Y	10/16/1991	10/20/1991	4	none	PVT	PVT	Sulfasalazine 500 TID, Prednisone 5mg QD.	none	Stable Crohn's disease	none~ ()~~~In patient		1						1	Facial palsy	FLU3~CONNAUGHT LABORATORIES~1F21213~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0038143	12/26/1991	CO	47.0	47		F	12/17/1991	Cluster blisters on back of hand & inside mouth; also, mouth ulcers, taste buds on tongue swollen & painful;									Y	10/19/1991	10/20/1991	1		OTH	PUB	Inderal, Imipramine, Tegretol;	NO		~ ()~~~In patient		1						1	Dermatitis bullous; Glossitis; Mouth ulceration; Pain; Tongue oedema	FLUX~PFIZER\WYETH~4918137~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036935	12/27/1991	CT	22.0	22		F	12/17/1991	T99.2; pain @ inject site lt deltoid; hives; wheezing; Benadryl administered; dx: allergic rxn; recovery w/in 24 hrs;				Y					Y	11/06/1991	11/06/1991	0		MIL	MIL		NONE	NONE	~ ()~~~In patient	891343035L	1						2	Asthma; Hypersensitivity; Injection site pain; Pyrexia; Urticaria	FLUX~PFIZER\WYETH~4918177~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0036936	12/27/1991	CT	23.0	23		M	12/17/1991	Local pain/adenopathy @ inject site; paresthesia to fingers; recovery w/in 48hrs;				Y					Y	11/06/1991	11/06/1991	0		MIL	MIL				~ ()~~~In patient	891343036L	1						2	Injection site oedema; Injection site pain; Lymphadenopathy; Paraesthesia	FLUX~PFIZER\WYETH~4918177~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0036937	12/27/1991	CT	20.0	20		M	12/17/1991	Swelling/redness @ inject site; recovery w/in 24 hrs;				Y					Y	11/06/1991	11/06/1991	0		MIL	MIL				~ ()~~~In patient	891343037L	1						2	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4918177~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0036938	12/27/1991	CT	25.0	25		M	12/17/1991	T99.4; 3mm induration w/increased warmth @ site; recovery w/in 24hrs;				Y					Y	11/06/1991	11/06/1991	0		MIL	MIL				~ ()~~~In patient	891343038L	1						2	Injection site mass; Pyrexia; Vasodilatation	FLUX~PFIZER\WYETH~4918177~3~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0037234	12/27/1991	AR	84.0	83		F	12/19/1991	Pt recd vax & about 2 wks later presented to a dermatologist w/ c/o pain & erythema; dx: shingles; rx: Prednisone;				Y					Y	09/11/1991	09/18/1991	7	Routine dermatology tests;	PUB	PVT	Enalapril, Probenecid, Darvocet;	HTN, DJD, diverticulitis;	HTN, DJD, diverticulitis;	N/A~ ()~~~In patient		1						2	Herpes zoster; Pain; Rash	FLU3~LEDERLE LABORATORIES~310975~2~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~2	USA	Emergency room visit	Influenza
0037235	12/27/1991	AR	91.0	91		F	12/19/1991	Pt recd vax; about a month later pt came in w/ complaints of rash, low back pain & restlessness @ night;				Y					Y	10/24/1991			Routine physical exam;	PUB	PUB	Procardia XL, Digoxin, Synthroid;	HTN, ASHD, PUD, S/P MI;	HTN, ASHD, PUD, S/P MI;	N/A~ ()~~~In patient		1						2	Back pain; Insomnia; Nervousness; Rash	FLU3~LEDERLE LABORATORIES~310975~2~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~2	USA	Emergency room visit	Influenza
0038150	12/27/1991	OK	84.0	84		M	12/20/1991	Expired 04DEC91; medical examiner called Health Dept - death not due to vax;	Y	12/04/1991							N	12/04/1991	12/04/1991	0	NONE	PUB	PUB	Unknown;	Chronic heart disease;	Unknown;	No~ ()~~~In patient	OK9182	1						1	Unevaluable event	FLU3~CONNAUGHT LABORATORIES~1F21214~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0038153	12/27/1991	FL	72.0	72		F	12/01/1991	Pt became ill 3 days p/flu shot; rt upper outer abdominal pain, fever, chills, jaundice, elevated white blood count 14,000; elevated liver function tests; hepatitis;					Y	7			Y	11/07/1991	11/10/1991	3	Bilirubin 2.4; LDH 548; SGOT 98;	PVT	PUB		N/A	No known allergies;	~ ()~~~In patient		1						1	Aspartate aminotransferase increased; Blood lactate dehydrogenase increased; Hepatitis; Hyperbilirubinaemia; Infection; Jaundice; Leukocytosis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0037961	12/30/1991	GA	63.0	63		F	12/02/1991	Red papular rash appeared on buttocks, stomach approx 24 hrs post vax-non pruritic. Extended to include arms by 27Nov & seen in ER & tx /w cortisone inject.ER MD indicated the rash  could be sensitivity rxn to vax.				Y					Y	11/22/1991	11/23/1991	1	none	PUB	PUB	Norpace, Tenorssin	none	sprue, heart condition	~ ()~~~In patient	GA91317	1						1	Rash maculo-papular	FLUX~PFIZER\WYETH~4918132~1~IM L~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038160	12/30/1991	GA	81.0	81		M	12/02/1991	3Nov91: Pt called PHN, devel h/a on 26Oct91; 27Oct91 devel aches & pains;29Oct devel URI;took APAP, could not talk due to prolific s/s;felt better on 5Nov91.Pt's spouse has sxs only worse,did not have flu vax;21Nov91 pt & spouse well.									Y	10/25/1991	10/26/1991	1	none	PUB	PUB	none	none	none	none~ ()~~~In patient	GA91319	1						1	Headache; Myalgia; Pain; Pharyngitis; Speech disorder	FLUX~PFIZER\WYETH~4918201~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0038163	12/30/1991	CA	59.0	59		F	11/15/1991	Pt's husband reported pt was well until apparent stroke 8NOV91 @ 12noon; pt then died 9NOV91 @ 235AM; no autopsy was done; Cause of death listed as possible aneurysm;	Y	11/09/1991							N	11/06/1991	11/08/1991	2		PUB	PUB	Trilafor	NONE	Depression	~ ()~~~In patient	GA91323	1						1	Apnoea; Cardiac arrest; Cerebral haemorrhage; Cerebrovascular accident; Hypertension; Vascular anomaly	FLUX~PFIZER\WYETH~4918136~6~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0038170	12/30/1991	WA	71.0	71		F	12/04/1991	2 wks p/receiving flu vax noticed sinus ache, felt heavy also back of eyes next day felt shivery-shaking inside-noticed thick phlegm in back of throat; did not take temp; took meds; no cough; h/a 13DEC91; did not see MD;									Y	11/14/1991	11/30/1991	16		PUB	PUB		NONE	NONE	~ ()~~~In patient	WA91660	1						1	Asthenia; Chills; Headache; Rhinitis; Tremor	FLU3~PARKE-DAVIS~01381P~1~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~289906~1~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0038176	12/30/1991	NC	53.0			M		Guillain-Barre Syndrome; hospitalized 16NOV91; plasma replacement was carried out;					Y					10/31/1991	11/14/1991	14		UNK	UNK	Vitamin C, Tenormin, Amitriptyline;		Hx of sensory nerve disorder & hypertension;	~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLUX~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0038189	12/31/1991	AK	21.0			M	11/01/1991	The day p/the flu shot was given flu sx began & have continued for over 7 days; h/a, body aches, congestion, stuffy nose, lt ear plugged;														OTH	PUB		NONE	NONE	~ ()~~~In patient		1						1	Drug ineffective; Ear disorder; Headache; Influenza; Myalgia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~1F21213~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0038190	12/31/1991	AK	46.0	46		F	11/13/1991	Joints w/arthritis achey/sore next morning went away throughout the day;									Y	10/28/1991	10/29/1991	1		OTH	PUB				~ ()~~~In patient		1						1	Arthralgia; Arthritis	FLU3~CONNAUGHT LABORATORIES~1F21213~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0038191	12/31/1991	AK	48.0	48		F		Sore throat, plugged sinuses, body aches & pains, low grade temp, cough, chest pain, ear infect; treated as a cold w/juices, vit C cold meds & ATB prescribed by MD;										11/14/1991	11/15/1991	1		OTH	UNK		NONE		~ ()~~~In patient	AK91035	1						1	Chest pain; Cough; Myalgia; Otitis media; Pain; Pharyngitis; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~1F21213~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0038197	01/02/1992	VA	29.0	29		F		Pt recvd flu vax; 1/2 hr later had worsening of steroid dependent asthma; required transport to ER & then discharged home + larygospasm; unresponsive to 2 doses of Epi;				Y					Y	10/25/1991	10/25/1991	0		PVT	PVT	Proventil, Azmolart, Atrovent, MDI, Methotoxate, Prednisone, Theodur	stable		~ ()~~~In patient		1						1	Condition aggravated; Laryngospasm	FLU3~PARKE-DAVIS~01071P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0038205	01/03/1992	TX	55.0	55		F	11/22/1991	Rt arm swelling around inject site occurred 1 hr p/inject given; bruising, swelling area approx 5-6 cm in size; area tender & sore reddened & bruised on outside of induration;									Y	11/21/1991	11/21/1991	0		PUB	PUB		NONE		~ ()~~~In patient	TX91165	1						1	Ecchymosis; Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~1F21223~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~308913~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0038210	01/03/1992		43.0			F		fever blister;									U	11/14/1991	11/21/1991	7	NONE	UNK	UNK				~ ()~~~In patient		1						1	Mouth ulceration	FLU3~PARKE-DAVIS~01381P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0038326	01/06/1992	VA	70.0	70		M	12/19/1991	Husband & wife had same vax & illness hx; aching muscles, joints, anorexia; little if any elevated temp; onset 12DEC91 progressed to resp sx & bronchitis dx; 15DEC w/productive cough;									U	12/10/1991	12/12/1991	2	NONE	PUB	PUB		NONE	NONE	~ ()~~~In patient	VA91110	1						1	Anorexia; Arthralgia; Bronchitis; Cough; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~1F21216~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0038327	01/06/1992	VA	67.0	67		F	12/19/1991	Husband & wife had same immun & illness hx; aching muscles, joints, anorexia; little if any elevated temp; onset 12DEC91 progressed to respiratory sx & bronchitis dx 15DEC w/productive cough;									U	12/10/1991	12/12/1991	2		PUB	PUB		NONE	NONE	~ ()~~~In patient	VA91111	1						1	Anorexia; Arthralgia; Bronchitis; Cough; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~1F21216~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0038335	01/06/1992	NH	67.0	67		F	12/11/1991	13NOV91 came down w/viral pneumonia seen by MD x 2, antibiotics x 10 days; As of today 11DEC91 still running fevers & productive cough;				Y					N	10/23/1991	11/13/1991	21	13NOV CXR x 2; blood work;	PUB	OTH		No illness	NONE	NA~ ()~~~In patient		1						1	Cough; Infection; Pneumonia; Pyrexia	FLUX~PFIZER\WYETH~491820~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038336	01/06/1992	TX	48.0	48		M	01/01/1992	Intermittent rt deltoid pain dx of rt brachial neuritis by MD;tx Antiinflamm meds & PT;				Y					Y	10/11/1991	10/11/1991	0	23DEC91 EMG-WNL	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site pain; Neuritis	FLU3~CONNAUGHT LABORATORIES~04161P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0038474	01/07/1992	CO	46.0	46		F	12/09/1991	w/in 24 hrs of inject, pt had pain in arm beginning @ the site of inject, moving to lower arm & hand; pain w/some numbness have persisted since that time; pain worse when trying to close fingers in fist & w/greater activity;									N	11/12/1991	11/13/1991	1	NONE	PUB	PUB	Insulin	NONE	diabetes mellitus	cramps in thigh @45y/o w/Influenza;~ ()~~~In patient	CO9195	1						1	Injection site pain; Pain; Paraesthesia	FLUX~PFIZER\WYETH~4918146~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0038476	01/07/1992	CO	41.0	41		F	11/15/1991	31OCT91 site soreness, sl achey (no fever); 1NOV91 more achiness, extreme sensitivity to cold, achey joints; 2NOV91 general aching, joint aches-back, knees, ankles, awakened w/h/a; 4NOV91 fatigue & congestion of throat & chest (no cough);									U	10/30/1991	10/31/1991	1	NONE	PUB	OTH		no illness @ time of vax	NONE	NONE~ ()~~~In patient	CO9197	1						1	Arthralgia; Asthenia; Headache; Injection site pain; Lung disorder; Malaise; Myalgia; Rhinitis	FLUX~PFIZER\WYETH~4918146~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0038479	01/07/1992	CO	57.0	57		F	11/27/1991	48hrs p/flu shot raised red rash started @ ears, neck spread to chest, abd, hip/groin-scalp; Seen by MD rash dx viral exanthum given DPH for itching; no further flu vax t99.3; some itched areas were sl hive-like;				Y					Y	11/22/1991	11/24/1991	2		PVT	PVT			hx of skin rxn s/p hong kong flu (20 yrs ago) severe & s/p rxn w/steroid-skin rxn-dc'd meds allergic chloromycctin opthalmic	~ ()~~~In patient	CO91100	1						1	Infection; Pruritus; Pyrexia; Rash; Urticaria	FLUX~PFIZER\WYETH~4918213~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038486	01/07/1992	FL	63.0	63		F	12/18/1991	w/in 24 hrs p/inject started having aching in upper back, progressed to severe pain w/in 3 days then localized in lt scapula area & exists till present time; deep pain; also has severe h/a, top of head, temp inc 100 since 1 wk p/sx; flu sx				Y					N	11/22/1991	11/23/1991	1	NONE	PUB	PUB	NONE	NONE	allergic to sulfa, mold dust high cholesterol count	NONE~ ()~~~In patient	FL91069	1						1	Back pain; Headache; Influenza; Pyrexia	FLUX~PFIZER\WYETH~4918141~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038490	01/08/1992	DC	48.0			F	12/16/1991	Pt devel fever, sore throat, h/a & severe nausea & vomiting p/receiving flu vax; 4 days later, pt devel shock & was hospitalized; pt condition subsequently improved; Reporter was not aware of any allergies in pt;					Y				U	12/06/1991	12/06/1991	0		PVT	PVT		UNK		~ ()~~~In patient	891353001J	1						1	Headache; Nausea; Pharyngitis; Pyrexia; Shock; Vomiting	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0038491	01/08/1992	NJ	73.0	72		M	10/22/1991	Pt devel a rash, itching, & loss of energy w/in 12 days of flu vax;  rash began @ the inject site approx 1 wk p/vax; 9OCT91 pt was seen @ MD office w/a generalized rash & t101.6; Seen in ER t103 admitted; dx hypersensitivity rxn;				Y	Y	5			Y	09/27/1991	10/01/1991	4	Immune Complex 44.5; Blood Cultures showed Staphylococcus species; coagulase negative in one bottle only;	PVT	PVT	Vasotec tabs; Ecotrin tabs, Lasix tabs;	NONE	Pt has non-insulin dependent diabetes, hypertension, & arteriosclerotic heart disease; pt recvd flu vax 29OCT90;	~ ()~~~In patient	891316018L	1						1	Asthenia; Hypersensitivity; Infection; Injection site hypersensitivity; Pruritus; Pyrexia; Rash; Sepsis	FLUX~PFIZER\WYETH~4918140~2~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0038496	01/08/1992	MA	59.0	59		F	11/15/1991	3 days post vax pt devel apthous ulcers on anterior tongue, lips & anterior buccal mucosa; posterior wall of pharynx swelled & pt lost her voice; pt was febrile; no temp was recorded; stomatitis;				Y					N	10/31/1991	11/02/1991	2	Blood work, erythromycin treatment;	PUB	PUB	UNK	NONE	NONE	~ ()~~~In patient	MA91006	1						1	Mouth ulceration; Pharyngitis; Pyrexia; Speech disorder; Stomatitis	FLU3~CONNAUGHT LABORATORIES~~2~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0038605	01/09/1992	CA	48.0	48		F	12/30/1991	head congestion, sinus pain, green mucus, no fever; pt says dx was sinusitis; ATB given x 2; pt & MD do not feel this is any connection to flu vax;				Y					Y	11/27/1991	12/10/1991	13	MRI; CAT Scan planned; r/o chronic sinusitis;	PUB	PUB	Thyroxin, Provera, Premarin, ASA;	NONE	allergic to legumes; sinusitis; hypothyroid; hysterectomy;	~ ()~~~In patient	CA91184	1						1	Headache; Infection; Rhinitis; Sinusitis	FLUX~PFIZER\WYETH~4918169~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038607	01/09/1992	CA	67.0	67		F	11/22/1991	Large (3x4 in) red area lt deltoid; seen by ER MD placed on oral ATB;				Y					Y	11/14/1991	11/16/1991	2	NONE	PUB	PUB	Premerin	NONE	No known allergies to any of components	NONE~ ()~~~In patient	CA91186	1						1	Injection site hypersensitivity	FLUX~PFIZER\WYETH~4918169~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038608	01/09/1992	CA	45.0	45		F	12/05/1991	1 round red area @ inject site;									Y	11/14/1991	11/15/1991	1	NONE	PVT	PUB	Thyroid	NONE	No known allergies to any of components	NONE~ ()~~~In patient	CA91187	1						1	Injection site hypersensitivity	FLUX~PFIZER\WYETH~4918169~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0038609	01/09/1992	CA	58.0	58		F	11/22/1991	fifty cents size red area @ inject site w/in 5 min c/o light headedness take to ER observed; no meds given reversed by self;				Y					Y	11/14/1991	11/14/1991	0	NONE	PUB	PUB	Visken, Primarin	NONE	No known allergies to any of components	UNK~ ()~~~In patient	CA91188	1						1	Dizziness; Injection site hypersensitivity	FLUX~PFIZER\WYETH~4918169~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038610	01/09/1992	CA				F	11/22/1991	fifty cents size red area @ inject site noted 16NOV91; Seen by ER MD place on oral ATB;				Y					Y	11/14/1991	11/16/1991	2	NONE	PUB	PUB	Procardia, Basotec			NONE~ ()~~~In patient	CA91189	1						1	Injection site hypersensitivity	FLUX~PFIZER\WYETH~4918169~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038614	01/09/1992	CA	56.0	55		F	11/14/1991	Muscle aches, n,v; h/a slight fever; fully recovered p/approx 36 hrs;									Y	11/14/1991	11/14/1991	0		PUB	PUB	NONE	denies	NONE	~ ()~~~In patient	CA91193	1						1	Headache; Myalgia; Nausea; Pyrexia; Vomiting	FLUX~PFIZER\WYETH~4918169~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0038615	01/09/1992	CA	72.0	72		M	11/12/1991	Was fine a/flu shot; got vax in lt deltoid 23OCT91 & on 25OCT91 had pain lt hip to lt ankle (spasm in hip & burning pain along nerve to ankle)-neuralgias; Seen by MD who said cause was flu shot & gave Cortisone shot; pain relief occurred;				Y					Y	10/23/1991	10/25/1991	2	Blood & Urine tests normal;	OTH	PUB	Hydrodiruril, dynicace	denied	hx spinal tumor per MD	~ ()~~~In patient	CA91194	1						1	Hypertonia; Neuralgia; Pain	FLUX~PFIZER\WYETH~4918169~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038616	01/09/1992	CA	61.0	61		F	11/26/1991	Pt recvd vax @ 930AM & by noon devel severe migraine h/a; so severe that pt saw MD & got Demerol; Pt was fine by the following day;										11/14/1991	11/14/1991	0		OTH	PUB			hx of migraine-usually gets 100mg Demerol	~ ()~~~In patient	CA91195	1						1	Migraine	FLUX~PFIZER\WYETH~4918169~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0038618	01/09/1992	CA	50.0	50		F	12/11/1991	Onset malaise & muscle aching 7DEC PM followed by fever (hot), chills, diaphoresis, congestion, cough & h/a on 8DEC sx persisted through 12DEC91;										12/06/1991	12/07/1991	1	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	CA91197	1						1	Chills; Cough; Headache; Hyperhidrosis; Malaise; Myalgia; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~4918170~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0038619	01/09/1992	CA	51.0	51		M	12/13/1991	Onset muscle aches & malaise 30NOV91 @ 1PM fever 102 alternated w/chills & diaphoresis from MN 30NOV through 4DEC91 respiratory congestion, cough & h/a accompanied illness; weakness persisted until 8DEC;									Y	11/29/1991	11/30/1991	1	NONE	UNK	PUB	NONE	NONE	NONE	~ ()~~~In patient	CA91198	1						1	Asthenia; Chills; Cough; Headache; Hyperhidrosis; Lung disorder; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~4918170~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0038621	01/09/1992	CA	76.0	76		F	12/20/1991	4 hrs p/flu immun pt devel itching around eyes exp trouble taking a good breath, had brief tingling in legs; felt jittery & nervous 24 hrs p/sx; pt had a cough;				Y					Y	12/06/1991	12/06/1991	0		PUB	PUB	Cardezam, ASA, Valium	pt stated had chills & weakness	HTN, leaky heart valve, nervous condition allergic to PCN	NONE~ ()~~~In patient	CA91200	1						1	Cough; Dyspnoea; Nervousness; Paraesthesia; Pruritus	FLUX~PFIZER\WYETH~4918169~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038622	01/09/1992	CA	79.0	79		F	12/23/1991	2 days p/inject of vax pt c/o pain & burning sensation that radiated down rt arm to hand; numbness devel in hand, esp last finger on rt hadn is totally numb now; arm, shoulder, & axilla on rt side is affected; pt can't straighten fingers;				Y					N	11/25/1991	11/27/1991	2		PUB	PUB	Currently taking APAP	NONE	NONE	NONE~ ()~~~In patient	CA91201	1						1	Pain; Paraesthesia; Tachycardia; Vasodilatation	FLUX~PFIZER\WYETH~4918147~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~285909~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0038623	01/09/1992	CA	71.0	71		M	12/09/1991	Pt c/o dizziness, vomiting, diarrhea, nausea & feeling clammy; family called 911 thinking pt was having a heart attack; pt dx in ER as having labyrinthitis; pt blaming flu shot as the cause;				Y					Y	11/21/1991	11/30/1991	9	UNK	PUB	PUB	NONE	NONE	NKA, no hx of hlth problems	NA~ ()~~~In patient	CA91202	1						1	Diarrhoea; Dizziness; Hyperhidrosis; Nausea; Vestibular disorder; Vomiting	FLUX~PFIZER\WYETH~4918169~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038624	01/09/1992	CA	70.0	70		M	11/13/1991	On 4NOV91 pt recvd flu vax on 5NOV91 pt broke out in hives (lasting from 5th-8th) pt went to see own MD;				Y					Y	11/04/1991	11/05/1991	1	NONE	PUB	PUB	Micronase	NONE	No known allergies	UNK~ ()~~~In patient	CA91203	1						1	Urticaria	FLUX~PFIZER\WYETH~4918169~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038625	01/09/1992	CA	56.0	56		F	11/19/1991	On 14NOV91, pt recvd flu vax & devel fever of 100 on 15NOV91; also site of immun red & swollen; pts MD stated pt was very sensitive to get only 1/2 shot next time;				Y					Y	11/14/1991	11/15/1991	1	NONE	PUB	PUB	Synthroid	NONE	NKA-hx unk	~ ()~~~In patient	CA91204	1						1	Injection site hypersensitivity; Injection site oedema; Pyrexia	FLUX~PFIZER\WYETH~4918169~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038626	01/09/1992	CA	63.0	63		F	11/13/1991	Pt having sx of stuffy nose, cough & feeling malaise; recvd vax on 4NOV91 & pt started feeling ill on Sunday 10NOV91;									U	11/04/1991	11/10/1991	6	NONE	PUB	PUB	NONE	NONE	No known allegies, medical hx unk	UNK~ ()~~~In patient	CA91205	1						1	Cough; Malaise; Rhinitis	FLUX~PFIZER\WYETH~4918169~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0038710	01/10/1992	CO	35.0	35		F	11/22/1991	Wheezing; airway constriction; tightness in chest; Epi administered; sx resolved w/in 5 min; no further problems; checked w/client 22NOV no problems;									Y	11/14/1991	11/14/1991	0		PUB	PUB		NONE	PCN	~ ()~~~In patient	CO91106	1						1	Asthma; Chest pain; Laryngospasm	FLU3~PARKE-DAVIS~01481~2~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0038711	01/10/1992	CO	20.0	20		F	10/24/1991	c/o local inject site, urticaria, erythema, dizziness, feeling cold, BP 120/80, resp 78 given EPI @ 3PM called 911 transported to ER;				Y					Y	10/24/1991	10/24/1991	0		OTH	PUB	Imipramine, melluril		developmentally disabled	~ ()~~~In patient	CO91107	1						1	Chills; Dizziness; Injection site reaction; Rash; Urticaria	FLUX~PFIZER\WYETH~4918147~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038712	01/10/1992	CO	51.0	51		F	12/16/1991	probable GBS synd;					Y	14			Y	11/21/1991	11/27/1991	6	Multiple tests in hosp	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	CO9201	1						1	Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~1F21219~2~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0038715	01/10/1992	VA	53.0	53		F	01/08/1992	Devel tingling, mild vertigo, myalgias, & h/a 15 day post vax; on day of admission devel lt peripheral facial paresis w/difficulty closing lt eye & droop of lt side of mouth; probable GBS:					Y				N	12/11/1991	12/26/1991	15	CT Scan of brain-normal; Lumbar Puncture-normal;	PVT	PVT	UNK	NONE	hypertension, hypercholesterolemia	~ ()~~~In patient		1						1	Facial palsy; Guillain-Barre syndrome; Headache; Myalgia; Paraesthesia; Vertigo; Facial palsy; Guillain-Barre syndrome; Headache; Hypokinesia; Hypotonia; Myalgia; Paraesthesia; Vertigo; Facial palsy; Guillain-Barre syndrome; Headache; Hypokinesia; Hypotonia; Myalgia; Paraesthesia; Vertigo; Facial palsy; Guillain-Barre syndrome; Headache; Hypokinesia; Myalgia; Paraesthesia; Vertigo	FLUX~PFIZER\WYETH~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|FLUX~PFIZER\WYETH~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~4	USA	Hospitalisation	Influenza
0038716	01/10/1992	PA	61.0	61		F	12/30/1991	Severe h/a steady & pounding seen by MD 14OCT91; slight temp adm to hosp 16OCT91 when rt eye drooped; seen by neurologist while admitted;					Y	3				10/04/1991	10/12/1991	8	CT Scan;	PUB	PVT				~ ()~~~In patient	PA91390	1						1	Eye disorder; Headache; Pyrexia	FLUX~PFIZER\WYETH~4918181~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0038717	01/10/1992	PA	61.0	61		F	12/30/1991	Terrible pain in temple, throat & chest; initially MD prescribed DPH pills but these made her sick to stomach; had difficult breathing & chest hurt; To ER @ hosp 21SEp91; poss congestive heart failure admitted;					Y	18				09/19/1991	09/19/1991	0		PVT	PUB				~ ()~~~In patient	PA91394	1						1	Chest pain; Dyspepsia; Dyspnoea; Headache; Pharyngitis; Right ventricular failure	FLU3~CONNAUGHT LABORATORIES~1F21209~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0038718	01/10/1992	PA	71.0	71		F	09/30/1991	20SEP91 late evening couldn't get up out of chair; rt leg gave way when tried to stand; shooting pain rt leg lower back; taken to ER 22SEP91; back xray neg; Seen by MD 23SEP91; rx Pred; 30SEP91 sx improving;				Y					Y	09/17/1991	09/20/1991	3		PVT	PUB				~ ()~~~In patient	PA91397	1						1	Back pain; Hypokinesia; Pain	FLU3~CONNAUGHT LABORATORIES~1F21209~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0038719	01/10/1992	PA	74.0	74		M	12/30/1991	Rash all over body; Seen by MD; prescribed Pred;				Y					Y	10/29/1991	11/01/1991	3		PVT	PUB				~ ()~~~In patient	PA91393	1						1	Rash	FLU3~CONNAUGHT LABORATORIES~1F21209~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0038720	01/10/1992	PA	73.0	73		F	12/30/1991	Initially lt arm sore; later rt arm & upper legs very achy; no other sx; achiness persisted; 25NOV91 seen by MD; 27NOV91 seen by MD rx Pred x 5 days; by 2DEC91 improving;				Y					Y	10/25/1991				PVT	PUB				~ ()~~~In patient	PA91398	1						1	Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~1F21209~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0038721	01/10/1992	PA	58.0	58		M	12/30/1991	Rash on chest; seen @ ER rx w/DPH				Y					Y	10/16/1991	10/17/1991	1		PVT	PUB				~ ()~~~In patient	PA91391	1						1	Rash	FLUX~PFIZER\WYETH~4918170~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038722	01/10/1992	PA	71.0	71		M	12/30/1991	Swelling rt eye by 12OCT91 swollen shut; water blisters on eyebrow, forehead & scalp; 15OCT91 seen by MD @ ER dx probable flu reaction;				Y					Y	10/11/1991	10/12/1991	1		PUB	PUB				~ ()~~~In patient	PA91395	1						1	Dermatitis bullous; Face oedema	FLU3~CONNAUGHT LABORATORIES~1F21209~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0038723	01/10/1992	PA	55.0	55		F	12/30/1991	5OCT91 itchy; wheals, felt hot & cold; 6OCT91 taken to ER rx Pred & DPH; also exp muscle aches; no energy;				Y						10/04/1991	10/05/1991	1		PUB	PUB	Ceclor			~ ()~~~In patient	PA91389	1						1	Asthenia; Chills; Myalgia; Pruritus; Urticaria; Vasodilatation	FLUX~PFIZER\WYETH~4918170~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038724	01/10/1992	PA	68.0	68		F	12/30/1991	Itching all over, welts on back, chest, neck; Seen by MD 10OCT91; rx w/Hydroxyzine; relief from itching; rash fading 11OCT91;				Y					Y	10/05/1991	10/07/1991	2		PUB	PUB				~ ()~~~In patient	PA91396	1						1	Pruritus; Urticaria	FLUX~PFIZER\WYETH~4918181~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038725	01/10/1992	PA	80.0	80		F	12/30/1991	Burning sensation in throat; coughing, face flushed; seen @ 100 in ER @ hosp; t98.3, P107, R24, BP 133/79 episode reportedly lasted 30min;				Y					Y	10/02/1991	10/02/1991	0		PVT	PUB				~ ()~~~In patient	PA91392	1						1	Cough; Pharyngitis; Tachycardia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~1F21209~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0038727	01/10/1992	GA	20.0	20		F	10/26/1991	Redness, swelling & pain @ inject site (rt deltoid) that began w/in 24 hrs, worse @ 48 hrs, w/8x8 cm area of raised, tender indurated, erythema;				Y					Y	10/24/1991	10/25/1991	1	NONE	OTH	PVT			asthma	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~4918203~1~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~302904~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0038729	01/10/1992	IL	58.0	58		F	10/29/1991	Flu vax recvd 25OCT91 @ 1200 poss adverse reaction reported 29OCT91 pt states awakened from sleep w/blistering rash to rt arm had neck & face; Denied any SOB; PDh taken for itching; pt seen 29OCT w/ resolving red raised rash;									Y	10/25/1991	10/25/1991	0	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Dermatitis bullous; Pruritus; Dermatitis bullous; Pruritus	FLU3~CONNAUGHT LABORATORIES~1F21213~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~1F21213~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0025075	01/13/1992	NJ	43.0	43		F	12/19/1991	Pt exp swelling & pain of her lt arm, neck, elbow, wrist & shoulder immediately p/receiving flu vax; also exp arthritis & lymphadenopathy which required hospitalization & 2 surgical operations; exp numbness, dec movement & pain;					Y			Y	N	11/07/1989	11/07/1989	0		OTH	OTH	UNK	UNK		~ ()~~~In patient	B073089147	1						2	Arthralgia; Arthritis; Back pain; Hypokinesia; Injection site hypersensitivity; Lymphadenopathy; Neck pain; Paraesthesia	FLUX~PFIZER\WYETH~4898169~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation,Disabling	Influenza
0038733	01/13/1992	MS	79.0	79		M	12/05/1991	1 day p/receiving flu vax, pt exp sleepiness & c/o not feeling well; vomiting 2 days p/vax & the vomitus was noted to be brown; pt died on 17OCT91; COD congestive heart failure;	Y	10/17/1991							N	10/13/1991	10/14/1991	1		OTH	OTH	NONE	NONE		~ ()~~~In patient	891361004J	1						1	Malaise; Right ventricular failure; Somnolence; Vomiting	FLUX~PFIZER\WYETH~4918138~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0038734	01/13/1992	MS	88.0	88		F	12/05/1991	w/in hrs of receiving flu vax pt began shaking & exp vomiting w/a small amount of blood noted; following morning pt exp chest pain, SOB, paleness & clamminess; pt was hospitalized & died 15OCT91; COD congestive heart failure;	Y	10/15/1991			Y	1			N	10/13/1991	10/13/1991	0		OTH	OTH	NONE	NONE	pt had diabetes, congestive heart failure & a peptic ulcer;	~ ()~~~In patient	891361005J	1						1	Chest pain; Dyspnoea; Haematemesis; Hyperhidrosis; Pallor; Right ventricular failure; Tremor	FLUX~PFIZER\WYETH~4918138~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0038735	01/13/1992	MS	78.0	77		F	12/05/1991	Approx 5 days p/flu vax pt devel cold sx from which pt never recovered; On 25OCT91 pt exp hematuria & hypotension & died following day; COD was not felt to be secondary to the flu vax;	Y	10/26/1991			Y	1			N	10/08/1991	10/13/1991	5		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	891361002J	1						1	Haematuria; Hypotension; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4918138~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0038737	01/13/1992	NC	59.0	59		F	12/10/1991	Pt reported tongue felt different p/recvd flu vax 28OCT91 that evening pt devel a fever & ill feeling; following day pts tongue became raw & swollen w/welts & blisters; approx 2 wks later exp difficulty breathing & chest tightness;	Y								U	10/28/1991	10/28/1991	0		PVT	OTH	NONE	UNK	pt does not have an allergy to eggs	~ ()~~~In patient	891354001J	1						1	Aphthous stomatitis; Dysgeusia; Glossitis; Malaise; Myalgia; Pyrexia; Tongue disorder; Tongue oedema	FLUX~PFIZER\WYETH~4918132~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0038738	01/13/1992	MS	80.0	80		M	12/05/1991	Pt exp wheezing & chest congestion, which began five day p/receiving flu vax; pt required hospitalization for 6 days;					Y	6			Y	10/22/1991	10/28/1991	6		OTH	OTH	NONE	NONE	pt has Parkinson's disease, arteriosclerotic heart disease, & COPD	~ ()~~~In patient	891361006J	1						1	Asthma; Lung disorder	FLUX~PFIZER\WYETH~4918138~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0038739	01/13/1992	MS	86.0	86		F	12/05/1991	Pt devel cold sx & cough w/wheezing approx 2 wks p/receiving flu vax; also exp confusion & dilation of the pupils; The pt was hospitalized @ this time for a period of 11 days;					Y	11			Y	10/13/1991	10/28/1991	15		OTH	OTH	NONE	NONE	pt has chronic renal failure & anemia	~ ()~~~In patient	891361003J	1						1	Asthma; Confusional state; Cough; Mydriasis; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4918138~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0038752	01/13/1992	SC	52.0	52		M	11/20/1991	Rash on lt arm & lt chest area injection site was left arm occurred 2 hrs p/;									Y	11/13/1991	11/14/1991	1	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	SC91171	1						1	Rash	FLU3~CONNAUGHT LABORATORIES~1F21210~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0038763	01/13/1992	TX	65.0			M	01/07/1992	48 hrs following vax pt devel mild gait ataxia; this progressed over the ensuing wks to profound ataxia leading to inability to walk; limb ataxia dev together w/dysarthria which progressed nearly complet bulbar paralysis;	Y	01/02/1992		Y	Y	3		Y	N				Complete work-up by oncologist for neoplasm was neg; MRI of head, cysternogram & CSR exam neg;	PVT	UNK				~ ()~~~In patient		1						1	Coordination abnormal; Dysarthria; Gait disturbance; Paralysis	FLUX~PFIZER\WYETH~4918137~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1852S~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Results in Death	Influenza
0038764	01/13/1992	NH	63.0	63		F	01/06/1992	9OCT91 laryngitis w/dry, hacking cough, low grade temp x 1 wk; 16OCT91 productive cough, thick yellow sputum, dyspnea; 20OCT91 severe resp distress adm to hosp x 6 days sputum smear pneumococcal/strep dx flu/pneumonia;				Y	Y	6			Y	10/08/1991	10/09/1991	1	26OCT91 chest film-dx flu pneumonia; LLL-sputum & pneumococcus/streptococcus w/gram neg; CBC-smear; RADS; acid fast bacillus;	PUB	PVT		NONE	hypertension-arthritis of knees & lt ankle	~ ()~~~In patient		1						1	Cough; Drug ineffective; Dyspnoea; Infection; Laryngitis; Pneumonia; Productive cough; Pyrexia; Bronchitis; Cough; Dyspnoea; Laryngitis; Malaise; Pneumonia; Productive cough; Pyrexia	FLU3~CONNAUGHT LABORATORIES~1F21216~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~1F21216~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0038765	01/13/1992	IA	77.0	77		F	01/02/1992	Pt is immunosuppressed w/steroids poss delayed reaction?; pt devel low grade fever, myalgia, confusion, dizziness, general malaise, sore throat;					Y				U	10/15/1991	10/24/1991	9		OTH	OTH	Pred, Florinef, Quiphite, Lasix, Colace, KCL, Tavist, Calcium, Carafate, Questran		aplastic anemia orthostatic hypotension, osteoporosis;	NONE~ ()~~~In patient		1						1	Confusional state; Dizziness; Malaise; Myalgia; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~1F21205~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0038768	01/13/1992	CA	70.0	70		M	12/24/1991	8NOV91 approx feeling lightheaded-seem to have gotten progressively worse; 13NVO91 dizziness (had to grab counter) & nausea during day; went to bed & vomitted; Seen by MD said flu reaction; 15DEC91 evaluated for vertigo, mid ear probs;				Y					N	11/06/1991	11/08/1991	2	Hx of hypertension; (no rx);	PVT	PVT	NONE		hypertension	~ ()~~~In patient		1						1	Dizziness; Ear disorder; Nausea; Vertigo; Vomiting	FLU3~PARKE-DAVIS~01481P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0038770	01/13/1992	CA	76.0	76		M		Felt well p/immun until 29NOV91, when pt devel h/a; on the evening of 1DEC pt exp a very severe h/a, lightheadedness, & nausea; was seen in ER on 2DEC feels well;				Y					Y	11/19/1991	12/01/1991	12		OTH	PVT				~ ()~~~In patient		1						1	Dizziness; Headache; Nausea	FLU3~PARKE-DAVIS~01481P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0038778	01/13/1992	ME				U	12/11/1991	pt recvd vax 1630 on 29OCT91 sx of pain/lump in throat while eating soup @ 2130; difficulty sleeping lump seemed to inc spitting up clear mucous & salivation; lump disappeared by AM; Describes feeling achy & hot for next 24 hrs;									Y	10/29/1991	10/29/1991	0	NONE	PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Dysphagia; Insomnia; Myalgia; Pain; Pyrexia; Salivary hypersecretion	FLU3~CONNAUGHT LABORATORIES~1F21205~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0038783	01/13/1992	NY	70.0	70		F	12/07/1991	Pt devel severe & crippling pain in joints, fingers of both hands, toes, heels & instep of both feet; pain moves from one area to another & has incapacitated pt; walking regimen has ceased; site of inject very painful lt arm;									N	11/15/1991	12/01/1991	16	normal	OTH	PUB	Glucotrol, Mevacor	NONE	diabetes	~ ()~~~In patient		1						1	Arthralgia; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0038788	01/13/1992	NH	61.0	61		F	01/10/1992	Dizziness, nausea, vomiting for 1 day duration; no fever; no treatment;									Y	10/29/1991	11/08/1991	10	NONE	PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Dizziness; Nausea; Vomiting	FLUX~PFIZER\WYETH~4918125~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037210	01/14/1992	KS	68.0	68		F	12/13/1991	2 hrs p/receiving vax devel severe abdominal pain then became dizzy, lightheaded in acute distress; taken to ICU;					Y	1			Y	10/01/1991	10/01/1991	0		PVT	PVT	Advil, Multivitamins	NONE	NONE	~ ()~~~In patient	KS91082	1						2	Abdominal pain; Anaphylactoid reaction; Dizziness; Abdominal pain; Dizziness; Dyspnoea; Abdominal pain; Anaphylactoid reaction; Dizziness	FLUX~PFIZER\WYETH~4918139~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~297900~1~IM A~~PNEUMO (PNU-IMUNE)~1|FLUX~PFIZER\WYETH~4918139~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~PFIZER\WYETH~297900~1~A~~PNEUMO (PNU-IMUNE)~2|FLUX~PFIZER\WYETH~4918139~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|PPV~PFIZER\WYETH~297900~1~IM A~~PNEUMO (PNU-IMUNE)~3	USA	Hospitalisation	Influenza
0038793	01/14/1992	AZ	52.0	52		F	01/02/1992	Early pain lt sinus area tx w/Cipro early DEC; On 20DEC91 approx enlarged lymph nodes, difficulty swallowing, sl pain in lt ear area; On 27DEC91 severe pain from lt side of head to lt eye orbit, lt cheek & around ear to jaw; unable to chew;				Y					U	11/14/1991	12/20/1991	36	Neurological-muscle exam, checked hearing;	PUB	UNK	NONE	NONE	PCN, Iodine, Oral polio, duck eggs,1 kidney;	1966 @ 27 y/o had rxn to TOPV #1 dose;~ ()~~~In patient	AZ9202	1						1	Deafness; Dysphagia; Facial palsy; Headache; Lymphadenopathy; Pain; Deafness; Facial palsy; Lymphadenopathy; Pain	FLU3~LEDERLE LABORATORIES~314963~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|FLU3~LEDERLE LABORATORIES~314963~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~2	USA	Emergency room visit	Influenza
0038798	01/14/1992	KS	30.0	30		F	10/16/1991	1215-1230 head-dizzy-chills; pt did not feel well until 21OCT91;									Y	10/15/1991	10/15/1991	0		PUB	PUB		NONE		~ ()~~~In patient	KS91072	1						1	Chills; Dizziness	FLUX~PFIZER\WYETH~4918148~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0038810	01/14/1992	MD	84.0	84		F	11/12/1991	Devel head cold 24 hrs p/vax devel dull h/a @ same time; excessive nasal discharge x 3 days; no fever; fine today 12NOV91;									Y	11/06/1991	11/13/1991	7	NONE	OTH	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MD91100	1						1	Headache; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4918170~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0038815	01/15/1992		77.0			F	01/03/1992	Recurent uveitis p/receiving fluogen; pt had complicated surgery on lt eye w/resultant uveitis; 4mos p/complete recovery recvd vax w/in 2 wks had inflammation w/cystoid macular edema & reduced vision;									Y					OTH	OTH	UNK			~ ()~~~In patient	924091001	1						1	Cyst; Oedema; Rash maculo-papular; Uveitis; Visual disturbance	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0038816	01/15/1992	NV	81.0	81		M	01/07/1992	C/o muscular ache 2 days p/immun relieved of aches p/5 days; no c/o of other rxn when followed-up on 2DEC91; cardio-pulmonary arrest 18DEC91 @ 120PM; death certificate not available for review, as yet;	Y	12/18/1991							N	11/26/1991	12/18/1991	22	NONE	OTH	PUB	Home 02 therapy; voltaren 75 mg BID;	COPD	CHF, COPD	UNK~ ()~~~In patient	NV92001	1						1	Apnoea; Cardiac arrest; Myalgia	FLU3~PARKE-DAVIS~01481P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0038819	01/15/1992	OK	77.0	77		F	12/30/1991	Pt c/o sx 5DCE91 & 1130AM numbness of tongue; pt called clinic 6DEC91 c/o hives under rt breast, abdomen & groin area; also, c/o swollen lips; pt seen 6DEC91 w/edema of lips, hives & chest pain;				Y	Y	4			Y	12/05/1991	12/06/1991	1		PUB	PUB	Cardiazem	NONE	PCN & Sulfa-angina	NONE~ ()~~~In patient	OK9185	1						1	Chest pain; Face oedema; Tongue disorder; Urticaria	FLU3~CONNAUGHT LABORATORIES~1F21215~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~297901~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0037817	01/16/1992	CT	46.0			M	12/02/1991	19NOV91 8AM was advised that pt suffered an arrest @ night 18NOV91 paramedics were contacted, & pt died; It was reported to be an asthma attack; There was no autopsy; only timing relation to the flu vax;	Y	11/18/1991							N	11/18/1991	11/18/1991	0		PUB	PUB	UNK	asthma	asthma-otherwise unk	unk~ ()~~~In patient		1						2	Apnoea; Asthma; Cardiac arrest	FLUX~PFIZER\WYETH~4918169~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Results in Death	Influenza
0038869	01/17/1992	IL				U	12/19/1991	Nursing home pt devel a stroke approx 1 month p/being administered flu vax, pt subsequently expired;	Y								N	11/01/1991	12/01/1991	30	Not specified;	PVT	PVT	UNK	UNK	UNK	~ ()~~~In patient	891360001J	1						1	Cerebrovascular accident	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0038871	01/17/1992	IL				U	12/19/1991	Nursing pt devel a stroke approx 1mo p/being administered flu vax;					Y				U	11/01/1991	12/01/1991	30	not specified;	PVT	PVT	UNK	UNK	UNK	~ ()~~~In patient	891360002J	1						1	Cerebrovascular accident	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0038873	01/17/1992	CO	55.0	54		F	12/30/1991	9OCT91 pt recvd flu vax; 15OCT91 vomiting, high fever seen by MD initial labs showed elevated liver function tests which resolved by 22OCT91;									Y	10/09/1991	10/12/1991	3	lab showed elevated liver function test which resolved by 22OCT91;	PVT	PVT		nausea, fever	PCN allergy	~ ()~~~In patient	CO9203	1						1	Hepatic function abnormal; Pyrexia; Vomiting	FLUX~PFIZER\WYETH~4918169~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0038875	01/17/1992	MO	31.0	31		F	01/07/1992	8NOV sore throat in bed x 3 days, muscle fatigue cont weakness, muscle joint pain; to MD 26NOV mono test CBC-WBC 10,000 mono neg; no improvement numbness, coldness, tingling of fingertips; low grade temp;				Y						11/06/1991	11/08/1991	2	Mono lab, Rheumatoid arthritis, Hormone level, CBC;	OTH	PUB	NONE	NONE		~ ()~~~In patient	MO92003	1						1	Arthralgia; Asthenia; Myalgia; Myasthenic syndrome; Paraesthesia; Pharyngitis; Pyrexia	FLUX~PFIZER\WYETH~4918146~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038877	01/17/1992	MN	65.0	65		M	11/04/1991	Client c/o pain in lt arm, limited mobility, lasting 3 wks length was seen by MD;									Y	10/28/1991	10/30/1991	2	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MN91053	1						1	Hypokinesia; Pain	FLUX~PFIZER\WYETH~4918121~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0038885	01/17/1992	NY	61.0			M		Guillain-Barre Synd (GBS);					Y					11/27/1991	12/04/1991	7		UNK	UNK	Candiac			~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLU3~PARKE-DAVIS~04161P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0038889	01/17/1992	CA	54.0	54		F	12/09/1991	Got flu shot 1NOV91 & began sx of diarrhea, fatigue, anorexia, & nausea on 5NOV91; progressed to weakness & jaundice by 10NOV91 Seen by MD got ATB starting falling down alot on 13NOV91; admitted to hosp 20NOV91 dx w/encephalomyelitis;				Y	Y	30	Y		N	11/01/1991	11/05/1991	4	LP	PVT	PVT	Naprosyn, Estroderue, Seldane	NONE	has hayfever	NONE~ ()~~~In patient		1						1	Anorexia; Encephalitis; Hypokinesia; Jaundice; Myasthenic syndrome; Myelitis; Nausea; Urinary retention	FLUX~PFIZER\WYETH~4918127~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0038898	01/17/1992	NH	76.0			M		Severe myalgias arms, legs, back began w/in 24 hrs persisted unchanged x 17 day pain inc; ESR 41; temporal artery neg; no arthralgias;									U	11/11/1991	11/11/1991	0	ANA- 1:40; RA-neg; Aldolase & CPK-nl; H/H 14.1/41.9; BUN 26 LDH 193 (nl 94-172);	UNK	UNK	ASA, Niacin		Hypercholesterolemia mild	~ ()~~~In patient		1						1	Anaemia; Antinuclear antibody; Blood lactate dehydrogenase increased; Blood urea increased; Myalgia; Red blood cell sedimentation rate increased	FLUX~PFIZER\WYETH~4918125~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0038905	01/20/1992	MI	69.0	69		F	11/21/1991	Had nausea & vomiting 24OCT91 seen by MD BP 130/90 @ end of visit BP 120/80 normal; Phenergan supositories given; pt had relief of sx w/in a few hrs;				Y					Y	10/23/1991	10/24/1991	1	BUN, SGO, Profiles 5, CBC, Glucose;	PUB	PVT				~ ()~~~In patient	MI91108	1						1	Nausea; Vomiting	FLUX~PFIZER\WYETH~4918131~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038908	01/20/1992	MI	64.0	64		F	11/22/1991	No sx until p/48 hrs @ which time devel nausea x 7 days then devel sore throat, generalized aches, sore eyes & ears, tiredness; pt will phone MD w/sx;									Y	11/13/1991	11/15/1991	2	NONE	PUB	PVT	BP meds/ Diazide/ Calan/ Premerin		reps allergies-seasonal	~ ()~~~In patient	MI91111	1						1	Asthenia; Ear pain; Eye pain; Myalgia; Nausea; Pharyngitis	FLUX~PFIZER\WYETH~4918131~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0038715	01/21/1992	VA	53.0	53		U		Pt devel tingling, mild vertigo, h/a, myalgias & lt peripheral facial paresis w/difficulty closing lt eye & droop of lt side of mouth; On 2nd day of hospitalization pt transferred to another facility for plasma pheresis; poss GBS;					Y				U	12/11/1991	12/26/1991	15		UNK	UNK				~ ()~~~In patient		1						2	Facial palsy; Guillain-Barre syndrome; Headache; Myalgia; Paraesthesia; Vertigo; Facial palsy; Guillain-Barre syndrome; Headache; Hypokinesia; Hypotonia; Myalgia; Paraesthesia; Vertigo; Facial palsy; Guillain-Barre syndrome; Headache; Hypokinesia; Hypotonia; Myalgia; Paraesthesia; Vertigo; Facial palsy; Guillain-Barre syndrome; Headache; Hypokinesia; Myalgia; Paraesthesia; Vertigo	FLUX~PFIZER\WYETH~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|FLUX~PFIZER\WYETH~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~4	USA	Hospitalisation	Influenza
0038963	01/21/1992	IN	58.0	58		M	01/02/1992	several days following immin on 28Dec89, pt devel tingling in the extremities, later devel ascending flaccid motor paralysis & loss of deep tendon reflexes.Hospitalized, Guillain-Barre synd was dx & sequelae reportedly persist.				Y	Y	17			N	12/28/1989	01/07/1990	10	pt vax @ home	OTH	PVT	none			~ ()~~~In patient	920000501	1						1	Asthenia; Guillain-Barre syndrome; Hyporeflexia; Muscle spasms; Pain; Paraesthesia; Paralysis flaccid; Peroneal nerve palsy	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0038965	01/21/1992	CA	62.0	62		M	11/13/1991	9NOV91 cough & fever seen by MD dx laryngitis-rx Amoxicillin; 13NOV much imporved getting better; 27DEC91 recovered;				Y					Y	10/17/1991	11/09/1991	23	NONE	PVT	PUB	NONE	NONE	NONE	~ ()~~~In patient	CA9201	1						1	Cough; Laryngitis; Pyrexia	FLUX~PFIZER\WYETH~4918169~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038966	01/21/1992	CA	38.0	38		F	12/27/1991	2 wks following vax started having breathing difficulties has had acute breathing spasm which have continued & pt has hyperventilated; pt felt warm @ time of episodes; Pt seen by MD late OCT91 no treatment given;										10/08/1991	10/16/1991	8	NONE	PUB	PUB	NONE	NONE	asthmatic sensitive to dust pollen & some foods;	NONE~ ()~~~In patient	CA9202	1						1	Dyspnoea; Hyperventilation; Vasodilatation	FLUX~PFIZER\WYETH~4918154~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0038967	01/21/1992	CA	71.0	71		M	11/07/1991	Onset w/ h/a, fever, cough ATB taken x 7 days; cough continues w/call MD again due to painful cough; 10DEC recovered w/o further MD intervention;				Y					Y	11/06/1991	11/06/1991	0		PUB	PUB	Insulin, Diogial, THyroid, Arthritis	NONE	diabetes, arthritis, cardiac, hypertension	~ ()~~~In patient	CA9203	1						1	Cough; Headache; Pain; Pyrexia	FLUX~PFIZER\WYETH~4918169~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038968	01/21/1992	CA	75.0	75		F	12/16/1991	URI & cough; Seen by MD who prescribed Ceftin & cough suppressant; Recovered;				Y					Y	11/14/1991	11/23/1991	9		PUB	PUB		NONE	NONE	~ ()~~~In patient	CA9204	1						1	Cough; Pharyngitis	FLUX~PFIZER\WYETH~4918169~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038969	01/21/1992	CA	38.0	38		F	12/12/1991	Onset of sore throat, cough, sl fever;									Y	12/11/1991	12/11/1991	0		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	CA9205	1						1	Cough; Pharyngitis; Pyrexia	FLUX~PFIZER\WYETH~4918169~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0038970	01/21/1992	CA	29.0	29		F	12/13/1991	URI, h/a, fever, cough starting on E-Mycin 13DEC;				Y					Y	11/22/1991	12/04/1991	12		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	CA9206	1						1	Cough; Headache; Pharyngitis; Pyrexia	FLUX~PFIZER\WYETH~4918169~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038984	01/21/1992	CA	49.0	49		M	01/17/1992	15NOV91 tingling fingers & toes lt side numbness rt hand & foot; fatigue & muscular weakness; inc temp speech became more difficult; 19NOV91 placed on ventilator, only able to move lips shrug shoulder (tracheotomy); pneumonia;	Y	01/04/1992							N	11/08/1991	11/15/1991	7	CSF nl, ABG's nl; CBC-WBC 9,200, HGB 16.1, HCT 44.9; plat 218,000; ESR-6; IgG 421 dec; Drug screen neg; nerve conduction velocity study; suggests GBS, acute polyneuropathy;	PUB	PVT	ATB for pneumonia p/hosp	UNK	heart murmmer, takes Naprosyn	~ ()~~~In patient		1						1	Apnoea; Guillain-Barre syndrome; Myasthenic syndrome; Neuropathy; Paraesthesia; Pneumonia; Pyrexia; Speech disorder	FLUX~PFIZER\WYETH~4918147~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0038988	01/21/1992	FL	60.0	59		F	11/27/1991	Bradycardia, asystole, resp arrest; dx vasovagal episode w/ a systole;			Y	Y	Y	2			Y	11/27/1991	11/27/1991	0		PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Apnoea; Bradycardia; Cardiac arrest; Syncope	FLUX~PFIZER\WYETH~4918145~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0038997	01/21/1992	OR	71.0	71		F	10/18/1991	15OCT woke w/rash around waist area spread to chest, arms, legs went to MD was told was allergic reaction & given DPH;				Y					U	10/14/1991	10/15/1991	1		OTH	PVT	BP med; joint inflammation		HPTN on meds 3 wks meds for joint problems;	NONE~ ()~~~In patient		1						1	Hypersensitivity; Rash	FLUX~PFIZER\WYETH~4918147~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038998	01/21/1992	OR	34.0	34		F	10/18/1991	Pt recvd vax 14OCT & on 15OCT woke w/fever, 17OCT progressing to severe n,v; taken to ER told it was not vax; also has UTI & was put on ATB;				Y					Y	10/14/1991	10/16/1991	2		PUB	PVT	Ampicillin, Pyridium	NONE	UTI needing catheterization x 2	NONE~ ()~~~In patient		1						1	Nausea; Pyrexia; Urinary tract infection; Vomiting	FLUX~PFIZER\WYETH~4918147~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0039000	01/21/1992	WA	31.0	31		F	01/17/1992	Inject site knotted & was painful; 3-4 days later knot disappeared, pain remained 30DEC91; consulted MD cortisone shot given;										11/08/1991	11/08/1991	0		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site mass; Injection site pain	FLU3~CONNAUGHT LABORATORIES~1J21108~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0039005	01/21/1992	CA	41.0			F		Pain @ inject site on lt arm, immediate @ time of vax; has remainded painful @ same site since; PE-neg;									U	09/06/1991	09/06/1991	0		PVT	PVT	Depoestradiol, Cypionate	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site pain	FLU3~CONNAUGHT LABORATORIES~1F21201~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0039011	01/22/1992	MS	74.0	74		F	12/03/1991	Fever over 100, red warm @ site of inject;				Y					Y	12/02/1991	12/03/1991	1		PUB	PUB				~ ()~~~In patient	MS9201	1						1	Injection site hypersensitivity; Pyrexia; Vasodilatation	FLUX~PFIZER\WYETH~4918153~1~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~308911~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0039014	01/22/1992	IL	95.0			F		Approx 1 mo p/recvd flu vax, resident became difficult to arouse, verbally unresponsive 10DEC91 pt gradually improved 11DEC-14DEC91 then worsened on 15DEC91 & expired;	Y	12/15/1991							N	11/12/1991	12/10/1991	28		UNK	UNK	Lasix, SYnthroid, FESO4, Vitamin C, APAP		ASHD, CHF, hypothyroidisim, anemia, OBS	~ ()~~~In patient		1						1	Stupor	FLU3~PARKE-DAVIS~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0039015	01/22/1992	IL	85.0			F		Approx 1 mo p/recvd flu vax, pt devel rt sided weakness w/inappropriate speech on 14DEC91; on 16DEC91 speech became appropriate but rt sided weakness continues w/rt hand weakness;								Y		11/14/1991	12/14/1991	30	NONE	UNK	UNK	EC ASA, NTG patch, Lasix, K-DUR, Ditropan,Tolinase, Cardizem, Hydergine		no allergies; post hx of CVA,DMASHD, HTN	~ ()~~~In patient		1						1	Myasthenic syndrome; Speech disorder	FLU3~PARKE-DAVIS~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Disabling	Influenza
0039017	01/23/1992	NC	53.0	53		M	12/12/1991	Pt devel GBS p/receiving flu vax; pt was hospitalized on 16NOV91 & recvd plasma replacement therapy;				Y	Y	9			U	10/31/1991	11/14/1991	14		OTH	OTH	Amitriptyline, Tenormin	unk	pt has a hx of sensory nerve disorder & hypertension; He took Vit C when sx of a cold appeared 14NOV91;	~ ()~~~In patient	892003010L	1						1	Guillain-Barre syndrome; Myasthenic syndrome; Neuritis; Dysphagia; Facial palsy; Paraesthesia	FLUX~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0039021	01/24/1992	NY	28.0	28		F	01/09/1992	Pt exp pain @ inject site the day p/recvd flu vax; This pain continued to worsen until pt was unable to work; A bump was noted @ the inject site; MD dx tendonitis; pts MD felt area was inflamed but not infected; pt currently receiving PT;					Y			Y	Y	11/15/1991	11/16/1991	1	Blood work & X-ray results are pending;	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	892013001J	1						1	Hypertonia; Injection site inflammation; Injection site mass; Injection site pain; Myalgia; Myositis; Tendon disorder; Tenosynovitis	FLUX~PFIZER\WYETH~4918131~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0039023	01/24/1992	AZ	34.0	34		F	01/07/1992	Approx 16DEC91 pt felt numbness & dec movement in the rt side of the face; On 18DEC91 pt appeared in ER w/same sx & dec taste, dec muscle movement, dec sensitivity; dx probable Bells Palsey; ENT referral made;				Y					U	11/07/1991	12/16/1991	39	NONE	OTH	UNK	NONE	NONE	Previous hx of Bell's Palsy in 1975 w/more severe onset;	NONE~ ()~~~In patient	AZ9206	1						1	Ageusia; Facial palsy; Hypokinesia; Paraesthesia; Facial palsy; Hypokinesia; Paraesthesia	FLU3~LEDERLE LABORATORIES~314963~UNK~~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|FLU3~LEDERLE LABORATORIES~314963~UNK~IM~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~2	USA	Emergency room visit	Influenza
0039030	01/24/1992	KS	69.0	69		F	01/17/1992	Onset of severe pain base of skull, neck & across shoulders, w/resulting weakness; also exp myalgia, flaccid paralysis; unable to pick up objects; muscle dec, hyeresthesia, reflexes difficult to illicit; poss GBS; SEE WORM VERY DETAILED;					Y	7			Y	11/15/1991	11/28/1991	13	Myelogram; lab showed a leukocytosis of 16.1 w/o lt shift; spinal fluid no cells but a rising protein from 58 to 93 five days apart; UTI treated;	PVT	PVT	Cardizem, Premarin, Dyazide	NONE	EES, PCN, Keftabs, Teramycin; hx of chronic bronchitis, hypertension, arteriosclerotic heart disease	~ ()~~~In patient		1						1	CSF test abnormal; Guillain-Barre syndrome; Hyporeflexia; Leukocytosis; Myelitis; Neuritis; Paraesthesia; Paralysis flaccid	FLUX~PFIZER\WYETH~4918129~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0039033	01/24/1992	AZ	73.0	73		M	01/15/1992	Double vision, weakness & pain in feet, hands, arms, legs & back; Periods of sweating & aching; loss of sleep; loss of weight; 13th in 1 wk; numbness in hands & feet;				Y					N	11/05/1991	11/29/1991	24		PUB	UNK		NONE	Mild arthritis	~ ()~~~In patient		1						1	Amblyopia; Asthenia; Back pain; Hyperhidrosis; Insomnia; Myalgia; Paraesthesia; Weight decreased	FLUX~PFIZER\WYETH~4918150~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038715	01/27/1992	VA	53.0			F		Devel tingling, mild vertigo, myalgias, & h/a 15 days post vax devel lt facial paresis w/diff; poss GBS;					Y					12/11/1991	12/26/1991	15		UNK	UNK			hx of hypertension, hypercholesterolemia	~ ()~~~In patient		1						3	Facial palsy; Guillain-Barre syndrome; Headache; Myalgia; Paraesthesia; Vertigo; Facial palsy; Guillain-Barre syndrome; Headache; Hypokinesia; Hypotonia; Myalgia; Paraesthesia; Vertigo; Facial palsy; Guillain-Barre syndrome; Headache; Hypokinesia; Hypotonia; Myalgia; Paraesthesia; Vertigo; Facial palsy; Guillain-Barre syndrome; Headache; Hypokinesia; Myalgia; Paraesthesia; Vertigo	FLUX~PFIZER\WYETH~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|FLUX~PFIZER\WYETH~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~4	USA	Hospitalisation	Influenza
0039017	01/27/1992	NC	53.0	53		M	01/23/1992	Numbness in hands & feet lost control of arms & legs; facial paralysis, problems w/swollowing;					Y	28			N	10/31/1991	11/11/1991	11	EMG, nerve conductivity test, CSF protein, urine tests for heavy metals;	PVT	PUB	NONE	NONE	High BP, gout, peripheral neuropathy in feet;	~ ()~~~In patient		1						2	Guillain-Barre syndrome; Myasthenic syndrome; Neuritis; Dysphagia; Facial palsy; Paraesthesia	FLUX~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0039059	01/27/1992	TN	42.0	42		F	01/07/1992	Pt states on 3DEC91 pt awoke w/shoulder & back pain no tx sought; 5DEC rt knee swelled & became painful then better the next day sl but worsened again; pt called MD & saw MD 10DEC91 & 23DEC91 had numerous test dx w/infl arthritis;				Y						11/13/1991	12/03/1991	20		PUB	PUB		NONE	NONE	NONE~ ()~~~In patient	TN922	1						1	Arthralgia; Arthritis; Back pain; Osteoarthritis; Pain	FLU3~CONNAUGHT LABORATORIES~1F21220~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0039062	01/27/1992	TN	58.0	58		M	12/04/1991	Pt reported to clinic 4DEC91 that had a sz 3DEC91 taken to ER kept until 9PM;				Y					U	12/02/1991	12/03/1991	1	Had CT scan; referred for EEG;	PUB	PUB	Glyberide, Ibuprofen, Lopid, Minipress, Lopressor		Diabetes-Hypertension	~ ()~~~In patient	TN925	1						1	Convulsion	FLUX~PFIZER\WYETH~4918136~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0039077	01/27/1992	TN	74.0	74		M	01/20/1992	Pt was administered flu vax @ approx 1215 PM 20NOV91 VS-nl; pt had taken flu vax previously remained in the clinic for 15 to 20mins p/inject; pt passed out on the golf course @ approx 2PM to ER dx MI; no evidence of allergic rxn;	Y	11/20/1991							N	11/20/1991	11/20/1991	0	NONE	PVT	PVT	Calan, Synthroid, Feldene	NONE	No known allergies; hypertension, hypothyroidism, arthritis;	~ ()~~~In patient		1						1	Myocardial infarction; Syncope	FLUX~PFIZER\WYETH~4918132~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0039086	01/27/1992	TX	44.0	44		F	11/25/1991	Pneumovax site raised 1 cm diam, bluish & hard from day 1-3; Influenza vax site also raised & bluish had flu like sx w/about .75cm in diam; fever x 3 days;									Y	11/18/1991	11/19/1991	1	NONE	OTH	PVT	Imipramine	NONE	PCN, Demerol, Morphine	~ ()~~~In patient		1						1	Influenza; Injection site mass; Pyrexia; Skin discolouration	FLUX~PFIZER\WYETH~4918137~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~314912~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0035525	01/29/1992	IL	74.0	74		F	01/22/1992	GBS severe hosp care under MD;			Y		Y	21	Y			12/04/1990	12/19/1990	15		PVT	PVT	Regroton, Procardia			~ ()~~~In patient	891198011B	1						2	Guillain-Barre syndrome	FLUX~PFIZER\WYETH~4908195~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation	Influenza
0039169	01/29/1992	NH	74.0	74		M	12/30/1991	UNK									U	11/07/1991			UNK	OTH	PVT	UNK	NONE	UNK	UNK~ ()~~~In patient		1						1	Unevaluable event	FLUX~PFIZER\WYETH~4918141~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0039245	01/30/1992	NY	79.0	79		M	10/25/1991	Pt reported rash devel chest & neck, numbness & tingling of neck, throat, face, difficulty swallowing; called ER & advised to take APAP & sx subsided w/in 2 hrs & pt states all sx gone by morning;									Y	10/24/1991	10/24/1991	0		OTH	PUB	Ancef, Duricef;		C-5 quadriplegia	~ ()~~~In patient	NYS91109	1						1	Dysphagia; Paraesthesia; Rash	FLU3~PARKE-DAVIS~01371P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0039250	01/30/1992	OK	46.0	46		M	01/16/1992	5hrs p/inject pt started running temp & feeling real bad; p/bath noticed a fine rash on abdomen & arms; has slight runny nose & cough;									U	01/13/1992	01/13/1992	0		PUB	PUB		NONE	Bronchial asthma	pt felt bad @ age 45 w/flu 2nd yr~ ()~~~In patient	OK924	1						1	Cough; Malaise; Pyrexia; Rash; Rhinitis	FLUX~PFIZER\WYETH~4918169~3~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0038715	01/31/1992	VA	53.0	53		F	01/15/1992	15 days p/flu vax pt exp tingling, mild vertigo, myalgia, h/a; pt hospitalized & lt sided peripheral facial paralysis, difficulty closing lt eye, drooping mouth; Plasmapheresis given poss GBS;					Y				N	12/11/1991	12/26/1991	15		PVT	OTH	UNK	UNK	pt has hx of hypertension & hypercholesterolemia;	~ ()~~~In patient	892017008L	1						4	Facial palsy; Guillain-Barre syndrome; Headache; Myalgia; Paraesthesia; Vertigo; Facial palsy; Guillain-Barre syndrome; Headache; Hypokinesia; Hypotonia; Myalgia; Paraesthesia; Vertigo; Facial palsy; Guillain-Barre syndrome; Headache; Hypokinesia; Hypotonia; Myalgia; Paraesthesia; Vertigo; Facial palsy; Guillain-Barre syndrome; Headache; Hypokinesia; Myalgia; Paraesthesia; Vertigo	FLUX~PFIZER\WYETH~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|FLUX~PFIZER\WYETH~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~4	USA	Hospitalisation	Influenza
0039260	01/31/1992	ID	8.0	8		F	01/16/1992	6JAN92 mom noticed petechiae on pt lower legs; no fever no other sx; 7JAN92 seen by MD platelet ct 22; 8JAN92 seen by MD again PLT ct 69; 13JAN92 PLT ct 632 to see MD in 2 wks 28JAN92; mom stated MD felt blood dyscrasia maybe related to vax				Y					U	12/06/1991	01/06/1992	31	7JAN92 platelet ct 22; 8JAN92 PLT ct 69; 13JAN92 PLT ct 632;	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	ID92007	1						1	Blood disorder; Petechiae; Thrombocythaemia; Thrombocytopenia	FLU3~CONNAUGHT LABORATORIES~1F21220~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0039281	01/31/1992	WI	79.0	79		F	01/16/1992	1 1/2 wk p/shot got sore throat Mon AM went to ER on Tues Evening 19NOV hospitalized pneumonia, perforated bowel; died;	Y	11/26/1991		Y	Y	8			N	11/13/1991	11/18/1991	5		PUB	PVT	Comtrex, blood thinner, Imodium for diarrhea;	NONE	peripheral vascular	~ ()~~~In patient		1						1	Intestinal perforation; Pharyngitis; Pneumonia	FLUX~PFIZER\WYETH~4918131~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0039285	01/31/1992	WI	3.0	3		F	01/08/1992	Pt suffered a 45 min sz that had a gradual onset which progressed to unconciousness accompanied by periods of apnea & vomiting; Phenobarbitol used to terminate sz; pt was transferred p/being stabilized, to be observed & treated in PICU;			Y	Y	Y	4			Y	12/18/1991	12/20/1991	2	Negative EEG, CAT Scan, MRI, Chemistries, & CBC;	PUB	PUB	Albuterol nebulizer	NONE	asthma, premature @ birth, fundoplication 1 yr ago	NA~ ()~~~In patient		1						1	Apnoea; Convulsion; Stupor; Vomiting	FLU3~CONNAUGHT LABORATORIES~1F21213~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0039286	01/31/1992	WI	57.0	57		M	01/06/1992	Flu s/s (extreme fatigue, lt diarrhea) 24 hrs p/flu shot; lasted 1 wk chest tightness, dry cough, SOB progression worsened; MD never ordered BC recvd Keflex x 10 days; pt seen by cardiologist stated heart pumping capacity 30% due to vax;			Y						N	10/29/1991	10/30/1991	1	Echocardiogram;	OTH	PVT	NONE		artificial heart valve	NONE~ ()~~~In patient		1						1	Asthenia; Cardiovascular disorder; Chest pain; Cough; Diarrhoea; Dyspnoea; Influenza	FLUX~PFIZER\WYETH~4918131~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0039287	01/31/1992	WI	73.0	73		M	12/12/1991	Felt ill on 6DEC91 h/a, nausea, weakness, generalized aching; 10DEC early AM devel rt shoulder & chest pain; to hosp;				Y	Y				Y	12/04/1991	12/06/1991	2	MD feels no connection of apparent MI & vax;	PUB	PUB		NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Chest pain; Headache; Malaise; Myalgia; Myocardial infarction; Nausea; Pain	FLUX~PFIZER\WYETH~4918131~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0039288	01/31/1992	WI				F	11/22/1991	7NOV91 @ 8PM devel sore throat, temp, chills; occasional chills during next wk; on 14NOV temp spiked to 103 went to ER & was dx w/UTI & anemia;				Y					N	11/07/1991	11/07/1991	0		PUB	PUB		NONE	hypertension; thyroid	~ ()~~~In patient		1						1	Anaemia; Chills; Pharyngitis; Pyrexia; Urinary tract infection	FLU3~PARKE-DAVIS~01781P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0039289	01/31/1992	WI	32.0	32		F	11/27/1991	temp of 102, sore throat, cough w/greenish mucuous, body aches;				Y						11/15/1991	11/16/1991	1	Throat culture-neg; infectious Mononucleosis neg;	PUB	PUB	NONE	Denies	NONE	Pt exp aches in 1989 w/flu vax~ ()~~~In patient		1						1	Cough; Infection; Myalgia; Pharyngitis; Pyrexia	FLUX~PFIZER\WYETH~4918131~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0039290	01/31/1992	WI	58.0	58		F	11/05/1991	c/o itching & difficulty breathing;				Y					Y	10/22/1991	10/23/1991	1		PVT	PVT	NONE	NONE	allergies-PCN, metals, iodine, nickel	NONE~ ()~~~In patient		1						1	Dyspnoea; Pruritus	FLU3~CONNAUGHT LABORATORIES~1F21204~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0039291	01/31/1992	WI	68.0	68		F	11/18/1991	had inc temp palms hot, lt side where shot recvd ached for 2-3 days, had cold @ time of shot;									Y	10/30/1991	10/30/1991	0	NONE	OTH	PUB		sl URI	Diabetes, Heart Disease, HTN	~ ()~~~In patient		1						1	Injection site pain; Pyrexia; Vasodilatation	FLU3~PARKE-DAVIS~00971P~6~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0039292	01/31/1992	WI	46.0	46		F	12/11/1991	Became ill w/in 6-7 hrs p/immun; sx congestion, cough, pain in chest, lt arm; Seen by MD 10DEC91 has asthma;									Y	12/03/1991	12/03/1991	0		PUB	UNK		Asthma had been ill 1 wk prior	Asthma	~ ()~~~In patient		1						1	Chest pain; Cough; Malaise; Rhinitis	FLUX~PFIZER\WYETH~4918143~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0039293	01/31/1992	WI	86.0	86		M	11/25/1991	Had vax on 18NOV; on 19NOV started w/a sneezing cold, on 20NOV it went to lungs & 99.9 fever, much coughing, by 22NOV started to get better, by 23NOV was well again;									Y	11/18/1991	11/19/1991	1	NONE	PUB	PUB	Zantac	NONE	NONE	~ ()~~~In patient		1						1	Cough; Lung disorder; Pharyngitis; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~01781P~1~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0039310	02/03/1992	ME	25.0	25		F	01/08/1992	2 hrs p/vax pt exp stuffy nose, scratchy throat; 3.5 hrs chest tight, dyspnea, throat tight used proventil inhaler, went to ER fever 101, nausea, fever, aching x 36 hrs; bad aches & pain all over; eyes were swollen, burning, bloodshot;				Y					Y	12/12/1991	12/12/1991	0	NONE	OTH	UNK	NONE	NONE	asthma, allergic to mold, feathers,Niacin, Ampicillin	pts brother exp vomiting, aches @ 35 w/flu vax;~ ()~~~In Sibling		1						1	Chest pain; Conjunctivitis; Dyspnoea; Face oedema; Laryngospasm; Myalgia; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~1F21213~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0039320	02/04/1992	MI	41.0	40		M	11/05/1991	Raspy voice, losing voice, chest congestion, cough (like whooping-dry), elevated temp (no taken), pale, weak, dizzy, & light-headed; MD did not see pt but ordered Amoxicillin & decongestant;									U	10/16/1991	10/26/1991	10	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MI92002	1						1	Asthenia; Cough; Dizziness; Dysphonia; Lung disorder; Pallor; Pyrexia	FLUX~PFIZER\WYETH~4918131~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~308913~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0039321	02/04/1992	MI	76.0	75		F	01/07/1992	9NOV91 abdominal cramps;  10NOV01 vomiting; rx w/liquid diet admitted to hosp ICU dx dec NA & K; 11NOV -15NOV91 still weak-anorexic, depressed;				Y	Y	4			Y	10/25/1991	11/09/1991	15		PUB	PUB	Inderal, Dyazide, Elavil, Phenobarbital;	NONE	hypertension; depression	~ ()~~~In patient	MI92003	1						1	Abdominal pain; Anorexia; Asthenia; Depression; Hypokalaemia; Hyponatraemia; Vomiting	FLU3~CONNAUGHT LABORATORIES~1F21201~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0039336	02/04/1992	WA	67.0	67		F	01/04/1992	Severe arthralgia, myalgia & weakness;				Y						11/07/1991	11/18/1991	11	Sed rate 124; Na 126; WBC 17,800; Cl-90;	PUB	UNK	Synthroid, Probanthine	NONE	PCN, bee stings	~ ()~~~In patient	WA92672	1						1	Arthralgia; Asthenia; Hypochloraemia; Hyponatraemia; Leukocytosis; Myalgia; Red blood cell sedimentation rate increased	FLU3~PARKE-DAVIS~01881P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0039337	02/04/1992	WA	52.0	51		F	12/30/1991	phone call on 30DEC91 stating that rt arm had been very sore w/some numbness since inject was given; also having problems w/stiff, tight & sore neck; apparently has had hx of neck problems for many yrs; 13JAN92 rt arm has lump;				Y					Y	12/13/1991	12/14/1991	1	NONE	PUB	PUB	Hormones, Flexeril, Feldene, Advil, Anecin	NONE	Neck problems for past 25 hrs;	NONE~ ()~~~In patient	WA92674	1						1	Myalgia; Neck pain; Nuchal rigidity; Paraesthesia; Skin nodule	FLU3~CONNAUGHT LABORATORIES~1F21220~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~304906~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0039374	02/07/1992	NM	38.0	38		F	12/20/1991	4DEC91 MD seen @ ER erthromycin given 5DEC91 seen again in ER w/cough, not feeling well, congestion, numbness of hands; feet & SOB; transferred to hosp 5DEC91;			Y	Y	Y		Y		N	11/15/1991	12/02/1991	17	4DEC91 CBC-white count 8.4;	PUB	PUB	Taking Thyroid & cough med	pt stated no illness @ present	throid problems, allergies to sulfa, PCN, Codiene;	~ ()~~~In patient	NM91015	1						1	Cough; Dyspnoea; Malaise; Paraesthesia; Rhinitis	FLUX~PFIZER\WYETH~4918213~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0039389	02/07/1992	NM	49.0	49		F	11/15/1991	Pt called in to hosp 11NOV91 stated rxn to flu shot; next day lt arm broke out w/superficial rash then next day other arm got rash; pt is taking DPH for itching; advised by MD to call if any further problems;										11/05/1991	11/06/1991	1		PVT	UNK				~ ()~~~In patient		1						1	Pruritus; Rash	FLU3~PARKE-DAVIS~01681P~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0039396	02/10/1992	ID	45.0	45		F	01/28/1992	Pain in back, shoulders, neck, loss of balance, vertigo, weak, plugged ears, congestion in head, bronchitis, tired, tight band around head;				Y						11/19/1991	11/24/1991	5		PUB	PUB		NA	NA	~ ()~~~In patient	ID92009	1						1	Asthenia; Back pain; Bronchitis; Coordination abnormal; Ear disorder; Headache; Neck pain; Vertigo	FLU3~CONNAUGHT LABORATORIES~1F21220~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0039397	02/10/1992	ID	42.0	41		F	01/28/1992	w/in 15  of vax pt exp burning sensation from arm up to head, h/a 2-3 days later sore throat, cough, vomiting, diarrhea, laryngitis, sinus congestion, spot in chest hurts;				Y					N	11/19/1991	11/19/1991	0		PUB	PUB	Potassium, Premarin, Hydrochlorathiazide		Diabetes	~ ()~~~In patient	ID92010	1						1	Chest pain; Cough; Diarrhoea; Headache; Laryngitis; Pharyngitis; Rhinitis; Vomiting	FLU3~CONNAUGHT LABORATORIES~1F21220~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0039424	02/11/1992	GA	81.0	81		M	10/29/1991	29OCT91 c/o pain in upper rt arm lt arm chest, neck & top of head 1 day p/recvd vax; also c/o unable to sleep due to pain w/no relief w/OTC meds; no appetite x 3-4 days;									N	10/15/1991	10/16/1991	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	GA9202	1						1	Anorexia; Chest pain; Headache; Insomnia; Neck pain; Pain	FLU3~PARKE-DAVIS~04261P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~285904~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0039427	02/11/1992	GA	57.0	57		M	01/02/1992	GBS devel approx 3 wks p/vax plasmapheresis;							Y		U	11/20/1991	12/07/1991	17	Nerve conduction studies;	PUB	PUB		NONE	borderline diabetes	~ ()~~~In patient	GA9205	1						1	Guillain-Barre syndrome	FLU3~PARKE-DAVIS~01271P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~316924~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0039429	02/11/1992	GA	42.0	42		F	12/20/1991	t101 achy & very congested wheezing; no improvement given meds;				Y					N	12/05/1991	12/17/1991	12		PUB	PUB	Maxaire inhaler		asthma	~ ()~~~In patient	GA9207	1						1	Asthma; Lung disorder; Myalgia; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~1F21219~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0039455	02/14/1992	MI	70.0			U		Encephalitis; As of 11FEB92 no reports on lot # 1F21218 have been reported;	Y		Y		Y		Y			12/14/1991	12/14/1991	0		UNK	UNK				~ ()~~~In patient	CO4122	1						1	Encephalitis; Hypokinesia; Paraesthesia; Thinking abnormal; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~1F21218~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~1F21218~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0039467	02/14/1992	WA	38.0	38		F	02/04/1992	Shortly p/receipt of shot pt noted severe pain swelling in lt arm, elbow, fingers; pain then appeared in other extremities rt arm/hand lt ankle; pain was constant & shooting pains w/grip of hand; had to get wrist braces;				Y					U	10/28/1991			Electrical conduction for carpel tunnel-neg;	PUB	PVT	NA	NA	NA	~ ()~~~In patient		1						1	Antinuclear antibody; Arthralgia; Arthritis; Oedema; Osteoarthritis; Pain; Systemic lupus erythematosus; Tenosynovitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0039470	02/17/1992	AK	47.0	47		F	11/04/1991	Pt woke up in the middle of the night, night p/vax w/fever & chills; fever to 103, had a rash on back & chest; rt arm swelling & painful; 4NOV still occ getting fever & chills 12x8cm red raised area on rt arms; pt fully recovered;									Y	10/31/1991	11/01/1991	1		PUB	PUB		NONE		NONE~ ()~~~In patient	AK92002	1						1	Chills; Oedema; Pain; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~1F21213~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~302907~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0039472	02/17/1992	OH	77.0	77		F	11/04/1991	Sudden onset of lt side chest pain; elevated BP, irregular heart beat; admitted hosp;					Y					10/22/1991				UNK	PUB				~ ()~~~In patient	OH9196	1						1	Arrhythmia; Chest pain; Hypertension	FLU3~CONNAUGHT LABORATORIES~1F21214~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0039476	02/17/1992	OH	68.0	67		M	10/30/1991	Pt had flu shot 24OCT91 @ 230PM & 6PM could not move-called ambulance & went to ER;				Y					Y	10/24/1991	10/24/1991	0		PVT	UNK	Depo-Medril for back	back problems	back problems-arthritis degenerative	~ ()~~~In patient	OH91100	1						1	Hypokinesia	FLU3~PARKE-DAVIS~01481P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0039477	02/17/1992	OH	67.0	67		F	11/20/1991	Pain in arm x 7 days; Had to go to hosp x 5 days;				Y					U	10/27/1991	11/04/1991	8		PUB	PUB	Camaden for B. clot	NONE-tired	inc BP meds	~ ()~~~In patient	OH91101	1						1	Pain	FLU3~PARKE-DAVIS~01481P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0039478	02/17/1992	OH	54.0	54		M	11/18/1991	Rt arm pain -MD in ER said shot was given in wrong msucle; had pneumonia also; to hosp 16NOV;				Y					N	10/29/1991	11/01/1991	3		PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient	OH91102	1						1	Pain; Pneumonia	FLU3~PARKE-DAVIS~01481P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0039479	02/17/1992	OH	56.0	55		M	11/13/1991	Began w/head cold like sx went into small of back, legs were numb; feet & hands tingled lt eye wouldn't close; lt mouth turned in; ICU x 3 days;					Y	10				10/07/1991	10/19/1991	12	CAT Scan-neg for stroke; neuritis dx;	PVT	PVT	Hydroxy, Clonidine, Slobid, Proventil	COPD	COPD	NA~ ()~~~In patient	OH91103	1						1	Hypokinesia; Neuritis; Paraesthesia; Pharyngitis; Rhinitis	FLU3~PARKE-DAVIS~01481P~2~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0039480	02/17/1992	OH	72.0	72		F	11/14/1991	2 days unable to communicate; words disorganized (OK now); pain in body later head;				Y					N	11/04/1991	11/05/1991	1	CBC	PUB	PUB	NONE	NONE	NONE	NA~ ()~~~In patient	OH91104	1						1	Headache; Pain; Speech disorder	FLU3~CONNAUGHT LABORATORIES~1F21217~3~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0039481	02/17/1992	OH	35.0	34		F	12/09/1991	Felt an allergic rxn began wheezing; took inhaler but wheezying continued; took other meds & was okay;  Had another attack 30NOV;									Y	11/27/1991	11/27/1991	0		PUB	PUB	Theophylline	NONE	allergic to numberous things;	NONE~ ()~~~In patient	OH91105	1						1	Asthma; Hypersensitivity	FLU3~PARKE-DAVIS~01481P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0039482	02/17/1992	OH	69.0	69		F	11/25/1991	Chilling 8NOV, vomiting 9NOV & became dehydrated;					Y	3				11/06/1991	11/08/1991	2	Flu shots may have started it but a virus was involved;	PUB	PUB	Macradantoin	NONE	angina (stable)	NONE~ ()~~~In patient	OH91106	1						1	Chills; Dehydration; Infection; Vomiting	FLU3~PARKE-DAVIS~01481P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0039489	02/17/1992	OH	26.0	26		F	11/25/1991	On 21NOV91 pt recvd flu vax @ 340PM; mins later throat felt like it was swelling & face, hands, & fingers felt tingly; felt lightheaded; poss allergic rxn; went to ER;				Y					Y	11/21/1991	11/21/1991	0	dec K-nl next day; EKG-because of extra beats-became nl p/epi wore off;	PUB	PUB	Ceftin; Seldane		allergies to shellfish & sulfa & others not as severe;	NONE~ ()~~~In patient	OH91113	1						1	Dizziness; Hypersensitivity; Laryngospasm; Paraesthesia	FLU3~PARKE-DAVIS~01481P~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0039493	02/17/1992	OH	52.0	52		M	10/31/1991	pt c/o becoming ill w/in 1 hr of shot; pt felt weak, hot & cold flashes, loss of appetite, wanted to sleep all weekend; felt a little better, then 3-4 days ago became sick again; c/o croup like cough, vomiting;										10/18/1991	10/18/1991	0	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	OH91117	1						1	Anorexia; Asthenia; Chills; Cough; Dyspnoea; Laryngitis; Somnolence; Vasodilatation	FLU3~PARKE-DAVIS~01481P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0039494	02/17/1992	OH	59.0	59		F	10/31/1991	Pt states following flu shot on Friday bottom of rt foot started itching; shortly p/started devel hives on arms, upper legs, hips; following flu shot had some aching & chilling & nausea;				Y					Y	10/18/1991	10/18/1991	0	NONE	PUB	UNK	Heart meds	NONE	heart problems	NONE~ ()~~~In patient	OH91118	1						1	Chills; Myalgia; Nausea; Pruritus; Urticaria	FLU3~PARKE-DAVIS~01481P~2~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0039565	02/18/1992	CA	25.0	25		F	11/05/1991	Approx 45 min p/inject of vax into rt deltoid, c/o tingling, weakness, & loss of strength in rt arm;				Y					Y	11/05/1991	11/05/1991	0	NONE	PVT	PUB	UNK	NONE	UNK	~ ()~~~In patient	CA9209	1						1	Asthenia; Myasthenic syndrome; Paraesthesia	FLUX~PFIZER\WYETH~4918169~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0039567	02/18/1992	CA	34.0	34		F	12/28/1991	4 hrs p/vax pt exp runny nose, scratchey throat & devel joint pain 21DEC, t99.4 this AM otherwise not aware of inc temp;									Y	12/20/1991	12/20/1991	0	pt did not see MD;	PUB	PUB	NONE	Denies	NONE	~ ()~~~In patient	CA9211	1						1	Arthralgia; Pharyngitis; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~4918169~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0039579	02/18/1992	CA	76.0	76		F	01/22/1992	Onset of ataxia in lower extremities approx 2 days p/flu; tingling sensation in both arms; dysphasia & partial dysphagia;									N	12/04/1991	12/08/1991	4		PUB	PUB	NONE	Denies	Denies	Pt exp same sxs in 1988 w/flu vax;~ ()~~~In patient	CA9223	1						1	Coordination abnormal; Dysphagia; Paraesthesia; Speech disorder	FLUX~PFIZER\WYETH~4918169~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0039592	02/18/1992	TX	51.0	51		F	11/07/1991	Rash abdomen, chest, leg, fever, itching;				Y					U	11/05/1991	11/05/1991	0	NONE	PUB	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Pruritus; Pyrexia; Rash	FLUX~PFIZER\WYETH~4918149~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0039606	02/20/1992	MD	81.0	80		M	01/22/1992	21JAN92 sharp abdominal pain which stopped p/pt had bowel movement 1 time; It was a little thin-not watery; no fever, h/a, muscle pain or nausea; sl soreness site of inject duration 24 hrs;									Y	01/16/1992	01/21/1992	5		MIL	PUB		NONE	NONE	NONE~ ()~~~In patient	MD92005	1						1	Abdominal pain; Injection site pain	FLUX~PFIZER\WYETH~4918213~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0039625	02/21/1992	SC	36.0	36		M	02/17/1992	1.5 wks post vax pt devel-weakness, fatigue, numbness/tingling; progressed to a feeling of paralysis; admitted for SOB & chest pain; p/hospitalization pt unable to ambulate on own; also devel facial weakness; GBS;					Y	12			U	10/21/1991	11/03/1991	13	CSF: elevated protein;	PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; CSF test abnormal; Chest pain; Dyspnoea; Guillain-Barre syndrome; Hypokinesia; Paraesthesia; Paralysis	FLUX~PFIZER\WYETH~4918122~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0039651	02/24/1992	TX	45.0			F	01/21/1992	Redness, swelling @ inject site, pain radiating toward the arm pit;				Y					Y	01/17/1992	01/18/1992	1		PUB	PUB	Epidural	NONE	back problem	~ ()~~~In patient	TX9205	1						1	Injection site hypersensitivity; Injection site oedema; Pain	FLUX~PFIZER\WYETH~4918174~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~314912~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0039669	02/24/1992	PA	47.0	47		F	02/18/1992	Devel SOB & cough 4-6 hrs p/vax recvd; dx r/o rxn to immun; rx DPH, Epi, Guaifenedin; rx last 1 day DPH x 3 days condition improved dec cough upon d/c;				Y					Y	11/06/1991	11/06/1991	0		PUB	UNK	Insulin, Synthroid	NONE	diabetes	~ ()~~~In patient		1						1	Cough; Dyspnoea	FLU3~PARKE-DAVIS~1381P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0039683	02/25/1992	SC	36.0			M		1.5 wks p/flu vax pt felt weak & tired; pt devel numbness & tingling in hands & feet & described progressive weakness & feeling of paralysis; pt became SOB & devel chest pain which brought pt to hosp; p/admission, not amubulating, poss GBS;					Y				U	10/21/1991	11/02/1991	12	Prior to plasmapheresis tx, there were no relevent lab data;	UNK	UNK	NONE		NONE	~ ()~~~In patient		1						1	Asthenia; Chest pain; Dyspnoea; Guillain-Barre syndrome; Hypokinesia; Myasthenic syndrome; Paraesthesia; Paralysis	FLUX~PFIZER\WYETH~4918122~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0038764	02/26/1992	NH	63.0	63		F	02/22/1992	Pt recvd vax 8OCT91 by 9OCT91 pt devel laryngitis by 13OCT laryngitis/tracheitis gen malaise by 15OCT thick yellow sputum; seen by MD rx meds; now having severe dyspnea, cough, t99.2, very ill unable to breath;			Y	Y	Y	6			N	10/08/1991	10/09/1991	1	CXR-many while in hosp; pulm function test have seen pulmonary specialist;	PUB	OTH	Zestril, Naporsyn, Vitamins	NONE	hypertension-arthritis-obesity	laryngitis @ 63 w/flu vax 1990;~ ()~~~In patient		1						2	Cough; Drug ineffective; Dyspnoea; Infection; Laryngitis; Pneumonia; Productive cough; Pyrexia; Bronchitis; Cough; Dyspnoea; Laryngitis; Malaise; Pneumonia; Productive cough; Pyrexia	FLU3~CONNAUGHT LABORATORIES~1F21216~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~1F21216~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0039713	02/27/1992	MI	71.0			F		Pt devel encephalopathy thought to be encephalitis-unknown cause; (initially c/o numbness rt hand x 2 wks opposite arm from inject then deterioration of motor skills & mental status over 5 days;	Y				Y				U	12/14/1991			EEG-?temporal lobe problem, MRI; lab eval none positive;	UNK	UNK	Diabinese, Procardia XL, Tenormin, Capoten, Provachol, Aldactone, Lasix;		Type II DM-incr chol, HTN, CHF;	~ ()~~~In patient		1						1	Electroencephalogram abnormal; Encephalitis; Encephalopathy; Movement disorder; Paraesthesia; Thinking abnormal	FLU3~CONNAUGHT LABORATORIES~1F21218~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0039717	02/28/1992	OR	73.0			F	02/20/1992	Pt devel rash (vasculitis) on 2 occasions in 1990 & 1991 p/flu vax; dx dermatitis of unk etiology tx meds; 2 mos later rash cleared up & pt had low back pain; dx leukocytoclastic vasculitis; pt went to ER 1 wk later w/sacroiliac pain;										01/25/1991	01/25/1991	0		PVT	UNK	Provera, Premarin, Cardizem, Trillisate & Proventil inhaler;		h/o hypertension, osteoarthritis, & hypercholesterolemia	pt exp similar rxn w/flu vax 1st dose;~ ()~~~In patient	924091012	1						1	Back pain; Rash; Vasculitis	FLU3~PARKE-DAVIS~01870P~2~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0039719	02/28/1992	IL	40.0	40		F	11/11/1991	Pt exp temp elevation 99.2, h/a, nausea, vomiting & diarrhea p/recvd flu vax; pt hospitalized x 2 days due to persistent severe h/a; an MRI & LP were performed; Results are awaited;				Y	Y	2			Y	10/29/1991	11/02/1991	4		PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient	891343029L	1						1	Diarrhoea; Headache; Migraine without aura; Nausea; Pyrexia; Vomiting	FLUX~PFIZER\WYETH~4918135~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0039741	03/02/1992	HI	67.0	67		M	01/10/1992	Rash appeared about 1 mo p/pt recvd flu vax @ clinic on 18NOV91; Rash continues w/occasional remission; suggested reviewing all changes in lifestyle, ie foods, soaps, clothing, lotions, etc;									N	11/18/1991	12/18/1991	30	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	HI9201	1						1	Rash	FLU3~PARKE-DAVIS~01481P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0039742	03/02/1992	HI	92.0			F	11/25/1991	Provisional admission dx COPD, s/p rt femoral neck fracture; since prior vax, pt had been deteriorating clinically (intermittent confusion, disorientation, incontinent, poor appetite); final dx septic shock, UTI; pt died 9NOV91;	Y	11/09/1991							N	10/22/1991				OTH	PUB	APAP, Dulcolax, MOM, Theodur	COPD, rt femoral neck fracture, pneumoni	NKA; hx bilat pneumonia, COPD, hx hepatitis 1983, cataracts 1977, confusion, disorientation, incontinent, poor appetite;	UNK~ ()~~~In patient	HI9202	1						1	Sepsis; Shock; Urinary tract infection	FLUX~PFIZER\WYETH~4918147~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0039743	03/02/1992	HI	104.0	105		F	11/25/1991	Adm dx: ORIF-rt supracondylar fracture, gastric ulcer; final dx cardiorespiratory arrest, acute bronchitis, demantia-alzheimer's type, secondary dx malnutrition, dehydrat, ASCVD, osteoporosis, osteoarthritis;	Y	11/16/1991							N	10/27/1991				UNK	UNK	Dulcolax, APAP, MOM, Synthroid, Colase, MVI, CA supplement, Cipro;	pneumonia, malnutrition, s/p femur fract	NKA, alzheimer's dementia, chronic dermatitis, HTN, osteoporosis, osteoarthritis, hypothyroidism, incontinent, fragil skin w/some tears, poor appetite, & non ambulatory;	UNK~ ()~~0.00~In Patient	HI9203	1						1	Apnoea; Arteriosclerosis; Bronchitis; Cardiac arrest; Dehydration	FLUX~PFIZER\WYETH~4918147~UNK~IM~GM~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0039744	03/02/1992	HI	92.0			M	11/25/1991	adm dx rt lower lob pneumonia; final dx pneumonia, cerebrovascular accident; pt died 8NOV91;	Y	11/08/1991							N	10/28/1991			NONE	OTH	PUB	Ceclor, Pseudoephedrine	CVA w/progressive dementia, rt lobe pne	chronic cerebral ischemia w/progressive dementia, hx UTI, anemia of chronic disease, very lethargic, poor appetite; NKA;	UNK~ ()~~~In patient	HI9204	1						1	Cerebrovascular accident	FLUX~PFIZER\WYETH~4918147~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0039745	03/02/1992	HI	75.0	75		F	11/25/1991	adm dx dilated cardiomyopathy; COPD, chronic CHF, hx HTN,DJD; pt died 5NOV91;	Y	11/05/1991							N	10/29/1991				OTH	PUB	Zantac, fortax, digoxin, theophylline, solu-medrol, Capoten, Lasix;	Pneumonia, COPD;	Allergic to crab, shrimp, lobster; COPD, cardiomyopathy, hx HTN, degenerative joint dis, CHF; resp status secondary to pneumonia & pulmonary congestion;	UNK~ ()~~~In patient	HI9205	1						1	Unevaluable event	FLUX~PFIZER\WYETH~4918147~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0039778	03/04/1992	FL				F	02/10/1992	Pt began exp flu-like sx approx 1 mo p/flu vax; sx progressed, & pt sought med tx on 14MAR91; pt dx GBS secondary to flu vax; pt unable to return to work due to residual weakness & fatigue;								Y	N	01/26/1991	02/01/1991	6		OTH	OTH	UNK	UNK		~ ()~~~In patient	892045001L	1						1	Asthenia; Guillain-Barre syndrome; Influenza	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0039783	03/04/1992	ND	37.0			F	02/28/1992	16OCT91 pt recvd flu vax; 20OCT91 very tired, went to bed; 26OCT-27OCT91 worked & started to get hoarse; 28OCT very hoarse w/some myalgia; 30OCT-2NOV91 severe arthralgia, myalgia, hoarse, malaise, fever, chills, cough, pneumonia;				Y					Y	10/16/1991	10/20/1991	4	CXR-hazy; ill-defined modular density LUL; WBC-4.3; CRP-0.9;	PUB	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Arthralgia; Asthenia; Chills; Cough; Dysphonia; Myalgia; Pneumonia; Pyrexia	FLUX~PFIZER\WYETH~4918148~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0039787	03/04/1992	FL	30.0			M	02/27/1992	Severe pain in shoulder following a flu shot; pain continues p/ tx w/NSAID, medrol dose pad & physical tx;									N	11/15/1991	11/15/1991	0		OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Pain	FLU3~CONNAUGHT LABORATORIES~1F21209~1~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0039890	03/05/1992	TX	79.0	79		F	12/19/1991	Severe lt shoulder pain p/recvd flu vax on 6NOV91; tx w/NSAID's & subsequently Prednisone w/no relief; referred to Orthopedic surgeon;				Y					U	11/06/1991	11/07/1991	1		PUB	PVT				~ ()~~~In patient		1						1	Pain	FLU3~CONNAUGHT LABORATORIES~1J21108~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0039894	03/06/1992	CA	66.0			M		GBS in reported in pt who recvd flu vax; pt had flu shot on 15NOV91 & on 30NOV91 devel weakness & paresthesias in lower extremities which progressed until 2DEC91; pt hospitalized due to inability to walk;					Y				U	11/15/1991	11/30/1991	15	NONE	UNK	UNK	Isoptin, Lidex cream, verapamil hydrochloride, Flucinonide, Tetracyline		2 PPD of cigars for 50 yrs;	~ ()~~~In patient	924091007	1						1	Asthenia; Guillain-Barre syndrome; Hypokinesia; Paraesthesia	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0039895	03/06/1992	NJ				U		CNS problems, personality change, SOB & vertigo are reported in a pt who recvd flu vax  on 15OCT91; w/in 6 hr pt exp CNS problems, personality changes, SOB, vertigo; w/in 24 hrs pt had fever & chills; pt tx w/DPH & Theodur & recovered hrs;									Y	10/15/1991	10/15/1991	0		UNK	UNK			h/o allergies (milk products & dust), h/o personality changes;	~ ()~~~In patient	924091011	1						1	Chills; Depressed level of consciousness; Dyspnoea; Personality disorder; Pyrexia; Vertigo	FLU3~PARKE-DAVIS~01581P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0039896	03/06/1992	TX	77.0			M		GBS is reported in a pt who recvd flu vax; 12 days p/inject, pt had sudden paralysis & became paraplegic w/loss of motor & sensory neurological function below the level of T12; pt hospitalized & tx w/meds; MD expect recovery;					Y			Y	Y	09/24/1990	10/06/1990	12		UNK	UNK			pt had resection of abdominal aneurysm 4 yrs ago & CABG 6 yrs ago;	~ ()~~~In patient	904090005	1						1	CSF test abnormal; Guillain-Barre syndrome; Hypokinesia; Paralysis; Paraplegia	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation,Disabling	Influenza
0039897	03/06/1992	NJ				M		GBS is reported in pt who recvd flu vax;														UNK	UNK				~ ()~~~In patient	914090048	1						1	Guillain-Barre syndrome	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0039898	03/06/1992	IN	51.0			F		GBS is reported in pt who recvd flu vax; unk it pt recvd flu shot in past; 2 wks p/flu shot pt had laparoscopic cholecystectomy & during recovery devel paresis w/bladder incont;					Y					11/16/1990	11/28/1990	12		UNK	UNK			prior flu shot unk; consent form signed prior to flu shot;	~ ()~~~In patient	914090007	1						1	Guillain-Barre syndrome; Paralysis; Urinary incontinence	FLU3~PARKE-DAVIS~02590P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0039899	03/06/1992	MO	50.0			F		GBS reported in pt who recvd flu vax & 10 days p/flu shot pt was hospitalized for rapid progression of weakness; CT scan suggested surgical etiology for GBS; pt still exp muscle spasms;					Y			Y	N	10/15/1989	10/25/1989	10		UNK	UNK	Calan, Zantac, Zestril, & HCTZ & KCL;		Diet controlled NIDDM prior to GBS, now on insulin; flu shot in past w/out sequelae;	~ ()~~~In patient	914090006	1						1	Asthenia; Guillain-Barre syndrome; Hypertonia	FLU3~PARKE-DAVIS~01209P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation,Disabling	Influenza
0039900	03/06/1992	PA	70.0			M		GBS reported in a pt who recvd flu vax on 10SEP91 & on 7OCT91 was admitted to hosp w/dx of GBS; tx meds sx improved but still devel septic arthritis (staphylococcal);					Y					09/10/1991	10/07/1991	27		UNK	UNK	Insulin		pt is diabetic & taking insulin	~ ()~~~In patient	914091001	1						1	Arthritis bacterial; Guillain-Barre syndrome; Infection	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0039901	03/06/1992	AZ	67.0			F		Localized swelling & warmth are reported in a pt who recvd a dose of flu vax; The area of swelling & warmth was approx the size of a half-dollar; pt was fine in 5 days;										09/30/1990	09/30/1990	0		UNK	UNK			previous flu shot w/o sequelae	~ ()~~~In patient	914090021	1						1	Injection site oedema; Vasodilatation	FLU3~PARKE-DAVIS~02680P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0039902	03/06/1992	AZ	60.0			F		Localized swelling, erythema & warmth the size of a half-dollar are reported in a pt who recvd flu vax; rxn lasted 5 days;										09/30/1990	09/30/1990	0	NONE	UNK	UNK			previous flu shots w/o sequelae	~ ()~~~In patient	914090022	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0039903	03/06/1992	AZ	20.0			F		Swelling, warmth & pain of upper extremity reported in pt who recvd flu vax, pt arm swelled to twice nl size & was sore w/ridge across the arm; tx meds; swelling & soreness lasted 2 wks;									N	09/30/1990	10/01/1990	1		UNK	UNK			previous flu shots w/o sequelae;	~ ()~~~In patient	914090023	1						1	Myalgia; Oedema; Pain; Vasodilatation	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0039904	03/06/1992	CA	56.0			M		Painful muscle spasms reported in pt who recvd flu vax on 4OCT91 & on 5OCT91 devel painful muscle spasms involving anterior thigh muscle bilat; Pt seen by MD on 7OCT91 & found to have tender anterior & posterior thigh muscle;										10/04/1991	10/05/1991	1		UNK	UNK			No known preceeding injury or overuse of muscle	~ ()~~~In patient	914091002	1						1	Hypertonia; Myalgia; Pain	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0039905	03/06/1992	NY				F		Bell's palsy is reported in a pt who recvd flu vax & 5 wks flu shot, pt devel Bell's Palsy; As of 28FEB92 pt is much imporved w/minimal residual weakness; MD does not believe event assoc w/vax;										10/25/1990	12/02/1990	38		UNK	UNK			Not stated	~ ()~~~In patient	914090010	1						1	Asthenia; Facial palsy	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0039906	03/06/1992	IA	64.0			M		Bell's Palsy, myalgia & neck pain are reported in pt who recvd flu vax/pneumococcal vax; pt also recvd insulin; On 6OCT90 pt devel bell's palsy; prior to onset of bell's palsy pt had some myalgia & not feeling right; also paralysi										09/27/1990	10/06/1990	9		UNK	UNK	Insulin		NONE	~ ()~~~In patient	914090030	1						1	Facial palsy; Malaise; Myalgia; Neck pain; Paralysis	FLU3~PARKE-DAVIS~02590P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0039907	03/06/1992	FL	65.0			M		Bell's Palsy is reported in a pt who recvd flu vax; 24 hrs p/vax, pt devel bell's palsy, which has not entirely cleared p/4 wks, but is much improved; Pt has recvd many flu vax in the past w/o sequelae & has never had bell's palsy;										10/02/1990	10/03/1990	1		UNK	UNK				~ ()~~~In patient	904090013	1						1	Facial palsy	FLU3~PARKE-DAVIS~02580P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0039908	03/06/1992	NC	55.0			F		Muscle tightness is reported in pt who recvd flu vax & 3 days p/flu shot, pt devel tightness of neck & shoulder muscles; event lasted 3-4 wks & for past 3-4 wks pt has tightness of posterior of thighs & hip muscles;										12/26/1990	12/29/1990	3	JAN91 Sed rate-100; 20FEB91 sed rate=50; SMAC=WNL; ANA=neg;	UNK	UNK			no flu vax prior to this one	~ ()~~~In patient	914090013	1						1	Hypertonia; Red blood cell sedimentation rate increased	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0039909	03/06/1992	FL	60.0			F		Agitation reported in pt who recvd flu vax; agitation 12 hrs p/flu vax pt agitated x 1.5 hrs; sx cleared spontaneously; pt is also receiving HCTZ, & Theophylline, but not near time of agitation; pt has recvd flu vax w/o problems;										10/25/1990	10/25/1990	0		UNK	UNK	Hydrodiuril		pt occasionally takes theophylline but was taking none near time of agitation	~ ()~~~In patient	904090009	1						1	Agitation	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0039910	03/06/1992	TX	62.0			F		encephalitis is reported in a pt who recvd flu vax; day p/flu vax pt became lethargic, was unable to ambulate & didn't recognize family; Pt seen in ER dx of encephalitis;				Y					Y	09/09/1990	09/30/1990	21	Head CT Scan-WNL	UNK	UNK	Calan SR, Calcijex, Epogen, Imferon		Renal failure/dialysis; no prev flu shots; has diabetes mellitus-controlled by diet;	~ ()~~~In patient	904090007	1						1	Encephalitis; Hypokinesia; Somnolence; Thinking abnormal	FLU3~PARKE-DAVIS~02590P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0039911	03/06/1992	OH	45.0			F		Dyspnea, mental slowing & anxiety are reported in pt who recvd flu vax; pt also taking meds; pt exp events 20 min p/recvd flu vax; Pt immediately seen @ clinic;										12/28/1990	12/28/1990	0	NONE	UNK	UNK	Carafate, Darvocet-N 100, Premarin, Provera;		allergies to PCN, Ceclor, IVP dye, some foods;	~ ()~~~In patient	914090031	1						1	Anxiety; Dyspnoea; Thinking abnormal	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0039912	03/06/1992	CA	70.0			U		Tingling & numbness in face, confusion & h/a are reported in pt who recvd flu vax; the day p/vax pt devel tingling & numbness in face which lasted 24 hrs & confusion which lasted 3 hrs; there were no apparent sequelae;										10/15/1991	10/16/1991	1	NONE	UNK	UNK			NONE	~ ()~~~In patient	914090054	1						1	Confusional state; Headache; Paraesthesia	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0039913	03/06/1992	CA	70.0			U		Tingling & numbness in face, congusion & h/a are reported in pt who recvd flu vax; the day p/the vax, pt had tingling & numbness in face which lasted 24 hrs & confusion lasting 3 hrs; There were no apparent sequelae;										10/20/1991	10/21/1991	1	NONE	UNK	UNK			NONE	~ ()~~~In patient	914090053	1						1	Confusional state; Headache; Paraesthesia	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0039914	03/06/1992	OK	51.0			F		Syncopal episode, diaphoresis & paresthesias are reported in pt who recvd flu vax; w/in 45 mins of vax, pt exp brief syncopal episode followed by diaphoresis & paresthesias; pt taken to ER;				Y						11/07/1991	11/07/1991	0	NONE	UNK	UNK			allergy to sulfur & PCN & eggs	pt exp rxn w/flu shot 10 yrs ago;~ ()~~~In patient	914091060	1						1	Hyperhidrosis; Paraesthesia; Syncope	FLU3~PARKE-DAVIS~01381P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0039924	03/06/1992	TN	1.8	1	.8	M	01/31/1992	Pt recvd flu vax on 21JAN92 well pt @ time of inject; devel fever, cold, & congestion (general flu type sx) & poor appetite p/recvd flu vax;									N	01/21/1992	01/22/1992	1	NONE	PUB	UNK	NONE	NONE	food & milk allergies	NONE~ ()~~~In patient	TN9222	1						1	Anorexia; Influenza; Pharyngitis; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~1F21220~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0039940	03/09/1992	GA	58.0	58		F	02/11/1992	c/o pain in rt arm @ inject site of pneumonia vax; no knot, swelling or discoloration; started day of inject until present (4 months); 1st reported today 11FEB92;									U	10/16/1991	10/16/1991	0	NONE	PUB	PUB	NONE	NONE	Codeine; insect stings; cortisone	pt exp pain @ inject site for one month yrs ago w/tetanus unk dose;~ ()~~~In patient	GA9219	1						1	Injection site pain	FLU3~PARKE-DAVIS~01481P~3~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~308914~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0039950	03/09/1992	GA	56.0	56		M	11/20/1991	Myalgias, h/a, sore throat, cough, fever to 100 beginning 20NOV91 lasting approx 1 wk;									Y	10/22/1991	11/20/1991	29	20NOV91 viral throat culture pos influenza A Beijing;	PUB	PUB	Lanoxin, Procan	NONE	allergic to Demerol; Tacycardia rx w/Lanoxin/Procas	NONE~ ()~~~In patient	GA9229	1						1	Cough; Headache; Infection; Myalgia; Pharyngitis; Pyrexia	FLU3~PARKE-DAVIS~04261P~4~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0039970	03/09/1992	OK	67.0	67		M	03/02/1992	Aches, pains in lt leg;				Y					N	12/06/1991	12/13/1991	7	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	OK928	1						1	Myalgia; Pain	FLUX~PFIZER\WYETH~4918169~2~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~MERCK & CO. INC.~0784T~3~~LA~HEP B (FOREIGN)~1	USA	Emergency room visit	Influenza
0040025	03/09/1992	PA	46.0	46		F	11/14/1991	Severe cough, nausea; 14NOV91 chest pounds today; too ill to get out of bed, sore throat; fever 101;									N	11/08/1991	11/09/1991	1		PUB	PUB	High bld pressure meds			~ ()~~~In patient	PA91359	1						1	Chest pain; Cough; Malaise; Nausea; Pharyngitis; Pyrexia	FLU3~PARKE-DAVIS~01481P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0040029	03/09/1992	PA	74.0	74		U		leg swelled up, feet swelled up;									N	11/13/1991	11/13/1991	0		PUB	PUB	Thyroid pill, Calcium	Osteoporosis	Prev MVA injury cut deeply ing legs;	NONE~ ()~~~In patient	PA91363	1						1	Oedema; Oedema peripheral	FLU3~PARKE-DAVIS~01481B~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0040034	03/09/1992	PA	73.0	73		M	11/25/1991	Sensation of burning down entire arm to knuckles, as if a nerve was hit during administration of vax; Pt has had flu vax a/but never had this problem a/;									N	11/20/1991	11/20/1991	0		UNK	UNK	Theodur, Dilantin, Isordil	NONE	Asthma, sz, stroke	~ ()~~~In patient	PA91368	1						1	Neuralgia; Pain	FLU3~PARKE-DAVIS~01481P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0040035	03/09/1992	PA	65.0	65		F	11/21/1991	General lousy feeling; fever started sometime p/shot; tongue feels like its burning, throat feels like its burning; has lost 10 lbs;				Y					U	10/22/1991	10/23/1991	1	NONE	PUB	PUB	NONE	NONE	kidney infection, tongue feels like its burning	NONE~ ()~~~In patient	PA91369	1						1	Glossitis; Malaise; Pharyngitis; Pyrexia; Weight decreased	FLU3~PARKE-DAVIS~01481P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0040038	03/09/1992	PA	72.0	72		F	11/27/1991	Soreness @ site of inject, starting approx 2 days post vax; arm is still sore; prior to receiving the vax pt's arm was exposed to air condition;				Y					N	10/16/1991	10/18/1991	2		UNK	PUB	Haldol, Klonpin, & Maprosyn, Porzac	NONE	arthritis (knees)	~ ()~~~In patient	PA91372	1						1	Injection site pain; Myalgia	FLU3~PARKE-DAVIS~01481P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0040041	03/09/1992	PA	78.0	78		F	11/27/1991	weak, coughing;									N	11/19/1991	11/26/1991	7	NONE	PUB	PUB	Lozol, Troson, cardizan	NONE	heart condition, allergic to bananas, any frest, chocolate, seafood, codeine, ASA	NONE~ ()~~~In patient	PA91375	1						1	Asthenia; Cough	FLU3~PARKE-DAVIS~01481P~2~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0040047	03/09/1992	PA	80.0	79		F	12/02/1991	Felt hot painful, black & blue, pain, puffed up;									Y	11/27/1991	11/27/1991	0		PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	PA91381	1						1	Ecchymosis; Oedema; Pain; Vasodilatation	FLU3~PARKE-DAVIS~01418P~2~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0040084	03/09/1992	PA	69.0	69		F	12/26/1991	Pt devel upper resp sx, tightness in chest, cough, bronchitis; no fever, chills;				Y					Y	11/27/1991	12/22/1991	25	NONE	PUB	PUB	Safrend for thyroid	NONE	NONE	NONE~ ()~~~In patient	PA9220	1						1	Bronchitis; Chest pain; Cough; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~1F21202~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0040085	03/09/1992	PA	23.0	23		F	01/13/1992	On 1JAN92 stomach flu w/t102 x 24 hrs vomiting x 8-9 hrs; pt very weak for couple of days;									Y	12/09/1991	01/01/1992	23		PVT	PUB	NONE	NONE		NONE~ ()~~~In patient	PA9221	1						1	Asthenia; Drug ineffective; Influenza; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~01481P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0040120	03/09/1992	GA	33.0	33		M	03/03/1992	Pt recvd flu vax 25NOV91 & exp nausea, h/a early DEC, progressive paresthesias, weakness; pt hospitalized 27DEC91; pos Hep B surface core AB;					Y	7			Y	11/25/1991	12/17/1991	22	EMG, LP	PUB	OTH	NONE		apply fractures	~ ()~~~In patient		1						1	Asthenia; Headache; Hepatitis B surface antigen; Immunoglobulins increased; Nausea; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0040121	03/09/1992	GA	31.0	31		M	03/03/1992	quadriparesis, resp failure;					Y	60	Y		N	11/01/1991	12/14/1991	43	EMG, LP	OTH	OTH	Tranyene, Carafate, Prilosec, Darvocet		Ulcers, migraines, rt bell's palsey, situational depression	~ ()~~~In patient		1						1	Apnoea; Quadriplegia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0040910	03/10/1992	TN	50.0	50		F	09/26/1991	Pt recvd vax 14DEC90; 16DEC c/o numbness in hands & feet; later c/o weakness (trouble driving car); pt was examined & was nl x/sl ataxia; sent to neurologist 2JAN91; c/o aching & fever; dx dysthesia, psycosomatic overlay & depression; pain				Y					N	12/14/1990	12/16/1990	2	24SEP neurological & PE nl;	OTH	OTH	NA	NA	NA	NA~ ()~~~In patient	910177001	1						1	Asthenia; Coordination abnormal; Depression; Myalgia; Neurosis; Pain; Paraesthesia; Pyrexia	FLU3~LEDERLE LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0040911	03/10/1992	FL				U	10/02/1991	Approx 8-10 pts have exp diarrhea & stomach cramping w/in 48 hrs post vax; tx included Imodium; sx resolved w/in 24 hrs following treatment;									Y	08/01/1991			NA	PVT	PVT	NA	healthy		NA~ ()~~~In patient	910188301	1						1	Abdominal pain; Diarrhoea	FLU3~LEDERLE LABORATORIES~312978~1~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0040912	03/10/1992	PA	72.0	72		F		Pt exp redness, swelling & transient tightness of chest approx 5 min p/vax; tx w/analgesia & cold compresses; recovered w/no sequelae;									Y	12/20/1991	12/20/1991	0	NA	PVT	PVT	Verelan, Prozac		hypertension; major affective disorder; anxiety reaction; stress	NA~ ()~~~In patient	910190001	1						1	Chest pain; Oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~312979~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0040913	03/10/1992	MA	52.0			F	10/31/1991	Consumer reports that following vax in 1990, exp a swollen arm (size of 1/2 grapefruit), bronchospasm & itching approx 45 mins p/vax administered; Taken to ER; tx Atarax & cortisone;				Y					U				NA	OTH	OTH	NA		allergic to sulfa & FDC yellow #5; not allergic to eggs; hx of rheumatoid arthritis & asthma; pt had the flu vax in prev yrs;	NA~ ()~~~In patient	910206901	1						1	Asthma; Oedema; Pruritus	FLU3~LEDERLE LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0040914	03/10/1992	TX	45.0	45		F	11/05/1991	Pt vaxed 28OCT91 & on 3NOV91 seen in ER; unable to move arm-very painful dx inflammation of the tendon; afebrile; tx included anti-inflammatory meds; 4NOV91 pt improving;				Y					Y	10/28/1991	11/03/1991	6	NA	PVT	PVT	NA		pt had the flu approx 2-3 wks prior to vax; was vaxed about 5 days p/having flu-like vax sx;	NA~ ()~~~In patient	910210401	1						1	Hypokinesia; Pain; Tendon disorder	FLU3~LEDERLE LABORATORIES~310975~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0040915	03/10/1992	WI	1.5			F	11/11/1991	Consumer reports that pt recvd flu-vax 7NOV91 & exp fever of 99 lasting 24 hrs & vomiting approx 4 hrs p/vax; 10NOV pt taken to Er dx dehydration (no tx); @ the time of the report, pt had not vomited w/in the past 24 hrs;				Y					U	11/07/1991	11/07/1991	0	NA	OTH	OTH	NA		Down's synd; consumer reports that daughter has vomited p/eating eggs; not sure if egg allergy; pt recvd flu vax last yr;	NA~ ()~~~In patient	910212001	1						1	Dehydration; Pyrexia; Vomiting	FLU3~LEDERLE LABORATORIES~~2~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0040916	03/10/1992	CO	83.0	83		F	11/14/1991	Pt recvd flu vax 24OCT91 & 5NOV91 c/o rash over shoulder & down neck; also c/o poss herpes zoster lesion in rt eye; Given Zovirax & DPH; pt also sues Neodecadron Ophthal Ointment; Rash resolving; almost disappeared by 21NOV;				Y					U	10/24/1991	10/25/1991	1	NA	PVT	PVT	NONE	ONE	prev cancer of breast some 20 yrs ago; skin cancer in the post nose area;	~ ()~~~In patient	910216301	1						1	Herpes zoster; Rash	FLU3~LEDERLE LABORATORIES~314963~UNK~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0039455	03/11/1992	MI	70.0	70		F		Mom got up 15DEC91 hand was tingly started to work its way up rt arm; Taken to MD had tests run; could not find out what it was on 29JAN92; pt admitted self into hosp 4MAR92; cannot find out what is wrong yet;			Y	Y	Y	30	Y		N	12/14/1991	12/15/1991	1	NONE	PVT	OTH	Tenormin, Capoten, Allopurnol,Aldactone, Procardia, Pravoc HOL, Lasix, Diabinese	next morning numming to rt arm & ft	NONE	Pt exp rxn w/flu shot;~ ()~~~In patient		1						2	Encephalitis; Hypokinesia; Paraesthesia; Thinking abnormal; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~1F21218~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~1F21218~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0027152	03/12/1992	IL				F	12/06/1990	Poss GBS;					Y									UNK	UNK				~ ()~~~In patient	CO3728	1						2	Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0027502	03/12/1992	PA	70.0	70		F	01/23/1991	Acute suppurative parotitis, earache, headache; bacterial infect; consultant MD thought poss that immune system compromised by inject & because of pre-existing condition precipitated infection;				Y						01/04/1991	01/04/1991	0		PVT	PVT			sjogrens synd	~ ()~~~In patient	CO3707	1						2	Ear pain; Headache; Infection; Sialoadenitis	FLU3~CONNAUGHT LABORATORIES~0F11221~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0027529	03/12/1992	NH	78.0	78		F	01/18/1991	Pt hospitalized 7NOV90 w/dx of CHF; pt in & out hosp over next few wks; released again on 7FEB90 but readmitted 9DEC90 & dies in congestive failure;	Y	12/10/1990			Y				N	11/06/1990	11/07/1990	1	UNK	UNK	UNK				~ ()~~~In patient	CO3759	1						2	Right ventricular failure	FLU3~CONNAUGHT LABORATORIES~0F11226~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0028077	03/12/1992	WI	72.0	72		M	02/07/1991	Poss GBS while on vacation devel back pain, numbness & weakness in leg; hospitalized transferred to VA hosp; currently undergoing physiotherapy;					Y				N	10/16/1990	10/31/1990	15		MIL	OTH	diabanase			~ ()~~~In patient	CO3771	1						2	Back pain; Guillain-Barre syndrome; Myasthenic syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0J11164~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0028529	03/12/1992	CO				U		Probable GBS;									U					UNK	UNK				~ ()~~~In patient	CO3727	1						2	Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0028570	03/12/1992	PA	8.0			M	11/21/1990	hallucinations & night terrors in asthmatic									Y				NONE	PVT	PVT		NONE	asthmatic	~ ()~~~In patient	CO3716	1						2	Abnormal dreams; Hallucination	FLU3~CONNAUGHT LABORATORIES~0F11203~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0028571	03/12/1992	OH				F	12/11/1990	Prolonged intermittant fever, myalgias, fatiguing; initial rash, especially inject arm, pharyngitis/pleuritic discomfort;														PVT	PVT				~ ()~~~In patient	CO3721	1						2	Asthenia; Myalgia; Pain; Pharyngitis; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~0F11206~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0028572	03/12/1992	MT	52.0			F	12/11/1990	Arm hot to touch, muscle stiffness & swelling; no tx to date; had flu shot 5 yrs ago w/similar rxn; pt stated that they could not raise their arm laterally for over a yr;									Y	11/14/1990	11/14/1990	0		OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	CO3723	1						2	Hypertonia; Hypokinesia; Oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0028573	03/12/1992	MD	46.0			F	12/11/1990	Diffuse rash w/bullae 7 days post inject; area around umbilicus showing early signs of necrosis;					Y	5			Y	11/05/1990	11/12/1990	7	ESR elevated; C3 & C4 inc; WBC-13,000; varicella titer-neg; SMA7-WNL; dx bullae/inflamm infiltrate	MIL	MIL	UNK	UNK	UNK	~ ()~~~In patient	CO3724	1						2	Dermatitis bullous; Leukocytosis; Necrosis; Oedema; Red blood cell sedimentation rate increased	FLU3~CONNAUGHT LABORATORIES~~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0038729	03/12/1992	IL	58.0	58		F	10/29/1991	Itchy, blistery rash all over body; as of 29OCT91 arm, neck & face; oppposite arm as inject site;										10/25/1991	10/25/1991	0		UNK	UNK	NONE	NONE	NONE	~ ()~~~In patient	CO3996	1						2	Dermatitis bullous; Pruritus; Dermatitis bullous; Pruritus	FLU3~CONNAUGHT LABORATORIES~1F21213~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~1F21213~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0040992	03/12/1992	PA	50.0	49		M	10/29/1991	3 days post inject devel myalgias w/intermittent fever w/hives & chills; taking advil;										10/21/1991	10/25/1991	4		UNK	UNK				~ ()~~~In patient	CO3994	1						1	Chills; Myalgia; Pyrexia; Urticaria	FLU3~CONNAUGHT LABORATORIES~1F21213~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0040993	03/12/1992	AL				U		Chills & fever 104;									U				BC	PVT	UNK	Dialysis			~ ()~~~In patient	CO3991	1						1	Chills; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0040994	03/12/1992	MI	58.0	58		F	04/05/1991	4 wks post inject-wkly visit pt exp diarrhea, vomiting, CXR-diffuse COPD, limited infiltrate;									Y	10/09/1990	10/29/1990	20		PVT	PVT		pt in for a checkup		~ ()~~~In patient	CO3821	1						1	Diarrhoea; Infection; Lung disorder; Vomiting	FLU3~CONNAUGHT LABORATORIES~0F11217~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0040995	03/12/1992	MI	59.0	59		M	04/05/1991	Vomiting, diarrhea 2nd day post inject; pt in gen good hlth;									Y	11/13/1990	11/17/1990	4		PVT	PVT		pt came in for checkup		~ ()~~~In patient	CO3820	1						1	Diarrhoea; Vomiting	FLU3~CONNAUGHT LABORATORIES~0F11217~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0040996	03/12/1992	CA				M	03/04/1991	1 day post inject pt devel hoarsness, non-productive cough; Seen an allergist who referred to ENT MD; This MD told pt vax shocked vocal records & froze them; w/voic exercise pt voice has returned;														UNK	UNK			NONE	~ ()~~~In patient	CO3807	1						1	Cough; Dysphonia	FLU3~CONNAUGHT LABORATORIES~0F11223~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0040998	03/12/1992	NJ				M	01/15/1991	Severe chills & a fever of 99; took APAP to relieve chills & muscle aches; day of 31OCT90 temp rose to 102.6; low grade fever for 8 days post inject;									Y	10/30/1990	10/31/1990	1		PVT	UNK		NONE	NONE	NONE~ ()~~~In patient	CO3753	1						1	Chills; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0F11226~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0040999	03/12/1992	NY	44.0	44		F	12/13/1990	H/a in PM; next day 11DEC90 knock dizzy & h/a; 12DEC90 starting to feel better; prescribed APAP;									U	12/10/1990	12/10/1990	0		PVT	PVT		NONE	Not specified		CO3739	1						1	Dizziness; Headache	FLU3~CONNAUGHT LABORATORIES~0F11216~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0041000	03/12/1992	NY	1.0			U		Fever of 106 evening of inject;									Y	11/30/1990	11/30/1990	0	NONE	PVT	PVT		NONE	down's synd	NA~ ()~~~In patient	CO3735	1						1	Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0041006	03/12/1992					U	11/30/1990	Asthenia, chills, fever;									Y				NA	OTH	OTH				~ ()~~~In patient	CO3708I	1						1	Asthenia; Chills; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4918P2~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0041008	03/12/1992					U	11/30/1990	Temp not recorded, but believed to be over 37, chills, weakness, asthma worsened;					Y				Y				NA	UNK	UNK				~ ()~~~In patient	CO3707I	1						1	Asthenia; Chills; Condition aggravated; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4918P2~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0040225	03/16/1992	NY	57.0	57		M	02/20/1992	Warm sensation throughout body accompanied by palpatations, inc in BP;				Y					Y	11/29/1991	11/29/1991	0	EKG-nothing remarkable;	PVT	PVT		NONE	NONE	NONE~ ()~~~In patient		1						1	Hypertension; Palpitations; Vasodilatation	FLUX~PFIZER\WYETH~4918126~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0040231	03/16/1992	MA	54.0	54		U		Pt recvd vax & seemed fine, however, approx 15 hrs later woke up w/tingling her lips, hands & feet; This condition progressively got worse w/light-headedness, dizziness, ringing in the ears, h/a, & burning in the feet, legs & buttock;										11/22/1991	11/22/1991	0		UNK	UNK				~ ()~~~In patient		1						1	Dizziness; Headache; Pain; Paraesthesia; Tinnitus	FLU3~CONNAUGHT LABORATORIES~1J21108~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0040380	03/19/1992	GA	31.0	31		F	02/18/1992	Pt devel chills, low-grade fever, muscle pain, joint swelling hands, fatigue soon p/recvd flu vax; pt exp weakness, fatigue, & joint pain, devel autoimmun response; vertigo; pt antinuclear antibody titer was elevated;				Y	Y	4			N	11/02/1991	11/03/1991	1		PUB	PVT	NONE	NONE	pt has hx of asthma	~ ()~~~In patient	892050001B	1						1	Antinuclear antibody; Arthralgia; Asthenia; Immune system disorder; Myalgia; Osteoarthritis; Systemic lupus erythematosus; Vertigo	FLUX~PFIZER\WYETH~4918138~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0040382	03/19/1992	MD	37.0	36		F	11/15/1991	T101.3 x 1 day; 99.4 x 3 days; hot & cold chills x 2 days; aching intense x 6 days; aching sl x 4 days; Itching, swollen, redness arms & legs x 4 days intermittant h/a x 2 days;									Y	11/01/1991	11/06/1991	5	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MD92010	1						1	Chills; Headache; Myalgia; Oedema; Pruritus; Pyrexia; Vasodilatation	FLUX~PFIZER\WYETH~4918202~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0040383	03/19/1992	MD	75.0	75		F	11/21/1991	Onset 18NOV91 stuffiness, cold sweats, h/a, t97, fatigue; onset of diarrhea, vomiting, nausea 20NOV91 for one day; 21NOV91 c/o weakness, tired;				Y					Y	11/08/1991	11/18/1991	10	NONE	PUB	PUB	Normadine, glucatrol	NONE	diabetes, HTN, arthritis	pt exp anti-tetanus @ 45yrs w/anti-Tetanus~ ()~~~In patient	MD92011	1						1	Asthenia; Diarrhoea; Headache; Hyperhidrosis; Hypothermia; Nausea; Rhinitis; Vomiting	FLUX~PFIZER\WYETH~4918202~3~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~316924~1~IM~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0040384	03/19/1992	MD	65.0	65		M	11/15/1991	Pt recvd pneumo inject 6NOV91 c/o rt arm onset 11NOV91 of pain radiating to shoulder rt  & neck; sl swelling rt arm; performed arm exercise using 3lb;									Y	11/06/1991	11/11/1991	5	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MD92012	1						1	Neck pain; Oedema; Pain	FLU3~LEDERLE LABORATORIES~4918202~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|PPV~PFIZER\WYETH~287905~UNK~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0040385	03/19/1992	MD	41.0	41		F	11/08/1991	Redness & induration 2 7/8 x 3 1/3, warm @ site, pain @ site;									Y	11/07/1991	11/08/1991	1		PUB	UNK		NONE	NONE	NONE~ ()~~~In patient	MD92014	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLUX~PFIZER\WYETH~4918202~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0040386	03/19/1992	MD	70.0	69		F	11/14/1991	Flu shot given 5NOV; 12NOV ache all over-stomach pain & gas, h/a & fever; temp not taken;									U	11/05/1991	11/12/1991	7		PUB	PUB	NONE			NONE~ ()~~~In patient	MD92015	1						1	Abdominal pain; Flatulence; Headache; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~4918202~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0040387	03/19/1992	MD	69.0	69		M	11/20/1991	6NOV91 4PM exp dizziness; 8PM dizzy-room spinning, unable to get OOB; vomiting; adm to hosp & remains hospitalized x 5 days; MD r/o middle ear disorder;				Y	Y	10		Y	N	11/06/1991	11/06/1991	0	NONE	PUB	PUB	NONE	NONE		~ ()~~~In patient	MD92016	1						1	Delirium; Dizziness; Hypokinesia; Vestibular disorder; Vomiting	FLUX~PFIZER\WYETH~4918202~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0037224	03/23/1992	AK	56.0	56		F	02/27/1992	Broke out w/hives all over 20JAN92, itchy welts; this happens p/eating any meat or dairy product; went to MD 30th no treatment but agreed these were hives, this is an allergic reaction, may take DPH allergy continues;				Y					N	10/18/1991	01/20/1992	94	NONE	PVT	PVT	NONE	NONE	Dynamo laundry detergent, cheer detergent, erythromycin	~ ()~~~In patient		1						2	Immune system disorder; Urticaria; Hypersensitivity; Pruritus; Urticaria	FLUX~PFIZER\WYETH~4918121~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4918121~6~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0040548	03/24/1992	OK	66.0	66		F	03/05/1992	4 days post flu vax c/o cough, sore throat, muscle aches, h/a, then 8 days post shot pt seen in ER c/o abd pain & SOB, nausea, vomiting; pt given meds;				Y					Y	12/16/1991	12/20/1991	4	immune complex panel pos;	PVT	PUB	Insulin, prinivil, Zantac	NONE	hypertension, diabetes	NONE~ ()~~~In patient	OK929	1						1	Abdominal pain; Cough; Dyspnoea; Headache; Myalgia; Nausea; Pharyngitis; Vomiting	FLU3~CONNAUGHT LABORATORIES~1F21215~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0040549	03/24/1992	OK	78.0	78		M	03/05/1992	14NOV91 pt c/o sore throat, chest congestion, fever, fatigue, muscle aches; pt given Emycin x 10 days & deconamine x 10 days;									Y	11/05/1991	11/14/1991	9	NONE	PVT	PUB	Lanoxin, Tenoretic, Mevacor	NONE	PAD, hypertension, Hypercholesterdemia	NONE~ ()~~~In patient	OK9210	1						1	Asthenia; Lung disorder; Myalgia; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~1F21214~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0040571	03/24/1992		54.0			F		3 days p/recvd immun devel hives, x 3 days; 4 days p/vax devel rash x 1 day;										11/22/1991				UNK	UNK				~ ()~~~In patient		1						1	Rash; Urticaria	FLU3~PARKE-DAVIS~01381P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0040591	03/25/1992	CO	26.0	26		F	11/18/1991	Presented 12NOV w/hive like blotches to arms, trunk & lower extremities that itched; Seen that day @ clinic given DPH; ON 14NOV went to ER; also exp swollen hands;				Y					Y	11/11/1991	11/12/1991	1		OTH	PVT	NONE	NONE	had similar event once a/following ASA	~ ()~~~In patient	CO925	1						1	Oedema peripheral; Pruritus; Urticaria	FLUX~PFIZER\WYETH~4918151~3~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0040611	03/27/1992	WA	45.0	45		M	03/23/1992	c/o frequent colds & flu sx since recvd flu shot; c/o sinus congestion et h/a frequently; tx consists of OTC meds; duration of sx until present, reoccurring sx;									U	10/21/1991	11/07/1991	17	NONE	OTH	PUB	Zantac	NONE	hyperactive acidity in stomach	NONE~ ()~~~In patient		1						1	Headache; Influenza; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0J21108~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0040613	03/27/1992	ID	40.0			F	03/23/1992	Sl nausea, throat swelling red eyes w/discharge from eyes;									Y	12/03/1991				PUB	PUB		NA	NA	~ ()~~~In patient		1						1	Conjunctivitis; Nausea; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~1F21220~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0040800	03/31/1992	PA	79.0	79		F	10/25/1991	23OCT91 arm swollen, red, inflamed, itchy approx 3 around inject site no better 25OCT91;										10/22/1991	10/23/1991	1		PUB	UNK		NONE	NONE	~ ()~~~In patient	PA91336	1						1	Injection site hypersensitivity; Injection site inflammation; Injection site oedema; Pruritus	FLU3~PARKE-DAVIS~01481P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0040822	03/31/1992	CO	53.0	53		M	12/17/1991	cluster blisters on outside of cheek;									Y	10/19/1991	10/20/1991	1	NONE	OTH	PUB	NONE	NONE	unk	~ ()~~~In patient		1						1	Dermatitis bullous	FLUX~PFIZER\WYETH~4918137~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0040943	04/01/1992	DC	31.0	31		F	02/03/1992	c/o sore upper lt arm @ inject site; recvd flu inject 4DEC91 denies swelling, redness; currently arm is stiff & painful when getting up in PM; sx remain the same since day of inject; advised to see MD for eval of lt arm;									N	12/04/1991	12/04/1991	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MD92009	1						1	Hypertonia; Injection site pain; Pain	FLUX~PFIZER\WYETH~4918154~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0040944	04/01/1992	MD	69.0	69		F	12/05/1991	Dizziness, nausea, perspiring on forehead during night; Seen by MD AM 3DEC91 admitted to hosp 3DEC91 having multiple tests;					Y				Y	11/21/1991	12/02/1991	11	Brain Scan, EKG, ultra-sound-neck; ecchocardiogram, EEG, heart monitor, blood tests;	PUB	PUB				~ ()~~~In patient	MD92013	1						1	Dizziness; Hyperhidrosis; Nausea	FLUX~PFIZER\WYETH~4918202~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0040946	04/01/1992	MD	72.0	72		M	03/11/1992	Pt c/o onset of continuous pain in arm @ site of inject;								Y	N	10/22/1991	10/25/1991	3	x-ray of arm; no fracture 3FEB92;	PUB	PUB	UNK	bladder cancer	bladder cancer	~ ()~~~In patient	MD92021	1						1	Injection site pain	FLUX~PFIZER\WYETH~4918151~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0040947	04/01/1992	MD	64.0	64		F	03/11/1992	Pt devel pain & dec ROM in arm where the vax was recvd;								Y	N	10/22/1991	10/31/1991	9	x-ray pending;	PUB	PUB		NONE	hypertension	~ ()~~~In patient	MD92022	1						1	Hypokinesia; Pain	FLUX~PFIZER\WYETH~4918151~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0040951	04/01/1992	PA	79.0	79		M	03/24/1992	27DEC91 fever, fatigue, weak; 28DEC91 t102, ATB recvd; 31DEC91 fever, cough worse to hosp ER; cxr done; not admitted; 1JAN92  to hosp ER was admitted; heart stopped in ICU died 5JAN92;	Y	01/05/1992	Y	Y	Y	5			N	12/19/1991	12/27/1991	8	CXR	PVT	PUB	Chemotherapy w/Cytoxan, Vincristine, Procarbazine, Pred, & Bleomycin	Lymphoma	lymphoma, leukemia	NONE~ ()~~~In patient	PA9280	1						1	Cardiac arrest; Coagulopathy; Dyspnoea; Lactic acidosis; Pharyngitis; Pneumonia; Respiratory disorder; Sepsis	FLU3~CONNAUGHT LABORATORIES~1F21215~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0041083	04/06/1992	AZ	51.0	51		F	11/20/1991	Lt arm was swollen, red & hurt x 2 days beginning 24OCT91; 9NOV91 pt felt nausea, chills, very hot, h/a; pt didn't take temp; pt had muscle aches especially back of neck from 9NOV91 x 3 days; Pt took ASA & Tetracyline & fluids;									Y	10/24/1991	11/08/1991	15	NONE	PUB	PUB	NONE	NONE	allergic to Novacaine x 15 yrs;	NA~ ()~~~In patient	CA9230	1						1	Chills; Headache; Myalgia; Nausea; Neck pain; Oedema; Pyrexia; Vasodilatation	FLUX~PFIZER\WYETH~4918140~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0041084	04/06/1992	CA	50.0	49		M	11/20/1991	On 2nd day p/receiving vax noticed a lump-numbness & tingling feeling fore arm; to thumb & 2 fingers; 15NOV91 numbness still there area where shot given was jet black lasted for a wk;									Y	10/30/1991	11/02/1991	3		PUB	PUB	Tagamet	NONE	hiatal hernia	NA~ ()~~~In patient	CA9231	1						1	Injection site reaction; Paraesthesia; Skin discolouration; Skin nodule	FLUX~PFIZER\WYETH~4918169~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0041088	04/06/1992	CA	77.0	77		F	12/02/1991	28NOV91 pain, swelling, inc warmth & lump on LA @ site of shot; c/o pain, swelling & tenderness in joints; c/o wheezing; Seen by MD x 2; hospitalized x 2 days; dx w/Bell's palsey; c/o hearing loss 1 ear; tremors, nervous, depressed & teary;				Y	Y	2			N	11/26/1991	11/28/1991	2	NONE	PUB	PUB		NONE	UNK	UNK~ ()~~~In patient	CA9235	1						1	Arthralgia; Asthma; Deafness; Depression; Facial palsy; Injection site mass; Osteoarthritis; Tremor	FLUX~PFIZER\WYETH~4918170~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0041090	04/06/1992	CA	56.0	56		M	11/25/1991	Pt recvd vax 22NOV91 & by the next morning noticed heat, redness & pain @ the site of pneumococcal vax; Pt went to clinic & recvd ATB due to recent heart bypass surgery 5APR91; BY 25NOV91 swelling & heat down;				Y					Y	11/22/1991	11/23/1991	1		PUB	PUB	UNK	NONE	heart bypass surgery 5APR91; current heart valve problem;	~ ()~~~In patient	CA9237	1						1	Injection site pain; Vasodilatation	FLUX~PFIZER\WYETH~4918170~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~302905~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0036912	04/08/1992	NJ	22.0	22		F	12/03/1991	Pt exp an allergic rxn p/receiving flu vax; addtl info has been requested;					Y	1			U	11/29/1991	11/29/1991	0		OTH	OTH	UNK	UNK		~ ()~~~In patient	891364002J	1						1	Dyspnoea; Hypersensitivity; Urticaria; Anxiety; Dyspnoea; Hypersensitivity; Urticaria	FLUX~PFIZER\WYETH~4918140~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4918140~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0036913	04/08/1992	FL	72.0	72		M	09/13/1991	pt devel a large abscess on rt shoulder above breast p/recvd flu vax; pt was referred to a surgeon for tx; cult of the abscess showed salmonella & staph epidermidis;				Y					U	09/05/1991			lot# 4918122 was tested & found satisfactory w/no anomalies noted;	PVT	PVT	UNK	UNK		~ ()~~~In patient	891291024L	1						1	Abscess; Infection	FLUX~PFIZER\WYETH~4918122~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036914	04/08/1992	CA	67.0	67		M	10/08/1991	w/in 24 hrs of receiving the flu vax pt exp sl swelling of the lt side of face & sensitivity on inside of mouth; also exp swelling of the gland in jaw & difficulty swallowing; sore throat & similar sx w/flu;									Y	10/01/1991	10/01/1991	0		OTH	PVT	NONE	NONE	pt has hx of hypertension, polycythemia, & sking cancer	~ ()~~~In patient	891301008L	1						1	Dysphagia; Face oedema; Influenza; Lymphadenopathy; Pharyngitis	FLUX~PFIZER\WYETH~4918153~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036915	04/08/1992	IA				U	10/22/1991	Pt devel swelling & redness @ inject site p/receiving the flu vax;									U					PVT	PVT	UNK	UNK		~ ()~~~In patient	891316015L	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4918120~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036916	04/08/1992	IL	38.0	38		F	10/17/1991	p/receiving flu vax pt exp redness @ inject site as well as general fatigue; no febrile rxn was noted; an elevated sedimentation rate was noted 4 days later;									U	10/12/1991			sed rate 45;	PVT	PVT	UNK	UNK		~ ()~~~In patient	891316016L	1						1	Asthenia; Injection site hypersensitivity; Red blood cell sedimentation rate increased	FLUX~PFIZER\WYETH~4918124~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036917	04/08/1992	CA	75.0	75		M	10/18/1991	pt devel a red, raised rash over trunk & arms 9 days p/flu vax;				Y					Y	10/09/1991	10/18/1991	9		OTH	OTH	NONE			~ ()~~~In patient	891316017L	1						1	Rash maculo-papular	FLUX~PFIZER\WYETH~4918169~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036918	04/08/1992	MA	30.0			M	10/18/1991	2 wks p/recvd flu vax pt exp lt intercostal pain w/difficulty breathing; pain was initially attributed to the face that pt was using only 1 crutch on the rt side; pt seen by MD who felt intercostal pain was due to crutch use;				Y					U	10/01/1991	10/14/1991	13		PVT	PVT	unk	unk	pt has hx of shingles; recently, had a fractured ankle;	~ ()~~~In patient	891316019L	1						1	Chest pain; Dyspnoea	FLUX~PFIZER\WYETH~4918152~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036919	04/08/1992	MS	83.0	83		F	10/15/1991	48 hrs p/flu vax pt was note to have a BP of 80/22, c/o feeling sick, was pale; pt recovered;									Y	10/13/1991	10/15/1991	2		OTH	OTH	NONE	NONE	pt has diabetes, congestive heart failure, & malabsorption synd;	~ ()~~~In patient	891316020L	1						1	Hypotension; Malaise; Pallor	FLUX~PFIZER\WYETH~4918138~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036920	04/08/1992	NC				U	10/21/1991	pt devel an upper respiratory infect 2 to 3 days p/flu vax;									U					PVT	PVT	UNK	UNK		~ ()~~~In patient	891316021L	1						1	Pharyngitis	FLUX~PFIZER\WYETH~4918122~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036921	04/08/1992	NC				U	10/21/1991	pt devel an upper resp infect 2 to 3 hrs p/receiving flu vax;									U					PVT	PVT	unk	unk		~ ()~~~In patient	891316022L	1						1	Pharyngitis	FLUX~PFIZER\WYETH~4918122~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036922	04/08/1992	SC				U	10/29/1991	pt devel a h/a & soreness of the arm p/recvd flu vax;									U					PVT	PVT	UNK	NONE		~ ()~~~In patient	891324009L	1						1	Headache; Migraine; Myalgia	FLUX~PFIZER\WYETH~4918119~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036923	04/08/1992	OR	34.0	33		F	10/30/1991	pt exp lightheadedness & devel a funny taste in mouth immed p/recvd flu vax; on f/u pt reported that had devel labyrinthitis which lasted for 1 wk;				Y					Y	10/28/1991	10/28/1991	0		PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient	891324010L	1						1	Dizziness; Dysgeusia; Vestibular disorder	FLUX~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036924	04/08/1992	PA	34.0	34		F	10/30/1991	pt exp chills, vomiting, diarrhea, tiredness, pain @ inject site p/flu vax; while lying down reportedly lost consciousness 3 to 4 times for 10-15 seconds & 30-40 seconds;									Y	10/29/1991	10/29/1991	0		OTH	OTH	NONE	NONE	pt has a hx of fianting, usually assoc w/trauma;	~ ()~~~In patient	891324011L	1						1	Asthenia; Chills; Diarrhoea; Injection site pain; Syncope; Vomiting	FLUX~PFIZER\WYETH~4918171~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036925	04/08/1992	NC				F	10/29/1991	pt devel redness @ inject site p/recvd flu vax;									U					PVT	PVT	unk	unk	unk	~ ()~~~In patient	891329037L	1						1	Injection site hypersensitivity	FLUX~PFIZER\WYETH~4918141~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036926	04/08/1992	NH				U	11/07/1991	48 hrs p/recvd flu vax pt exp severe h/a, weakness, fatigue, & diarrhea;									U					PVT	PVT	UNK	UNK		~ ()~~~In patient	991343023L	1						1	Asthenia; Diarrhoea; Headache	FLUX~PFIZER\WYETH~4918152~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036927	04/08/1992	NH				U	11/07/1991	Pt exp h/a, vomiting, & weakness p/recvd flu vax;									U	11/01/1991				PVT	PVT	UNK	UNK		~ ()~~~In patient	891343024L	1						1	Asthenia; Headache; Vomiting	FLUX~PFIZER\WYETH~4918152~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036928	04/08/1992	NH				U	11/07/1991	Pt exp h/a, vomiting, & weakness p/recvd flu vax;									U	11/01/1991				PVT	PVT	UNK	UNK		~ ()~~~In patient	891343025L	1						1	Asthenia; Headache; Vomiting	FLUX~PFIZER\WYETH~4918152~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036929	04/08/1992	ME	78.0	78		U	11/05/1991	Pt devel a hematoma @ inject site p/receiving the flu vax;									U	11/04/1991	11/04/1991	0		PVT	PVT	UNK	UNK		~ ()~~~In patient	891343026L	1						1	Injection site haemorrhage	FLUX~PFIZER\WYETH~4918152~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036930	04/08/1992	ME	82.0	82		U	11/05/1991	Pt devel a hematoma @ inject site p/receiving the flu vax;									U	11/04/1991	11/04/1991	0		PVT	PVT	UNK	UNK		~ ()~~~In patient	891343027L	1						1	Injection site haemorrhage	FLUX~PFIZER\WYETH~4918152~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TTOX~SCLAVO~099A1~2~~~TETANUS TOXOID, ADSORBED (NO BRAND NAME)~1	USA		Influenza
0036931	04/08/1992	CO	37.0	37		F	11/07/1991	Pt exp fever, cough, sore throat, & weakness p/recvd flu vax;									U	10/17/1991	10/19/1991	2		PVT	PVT	UNK	UNK		~ ()~~~In patient	891343028L	1						1	Asthenia; Cough; Malaise; Pharyngitis; Pyrexia	FLUX~PFIZER\WYETH~4918203~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036932	04/08/1992	IA	37.0	37		U	11/06/1991	Pt devel red welts (5-10cm) & itching @ inject site p/receiving the flu vax;									U	11/04/1991	11/05/1991	1		PVT	PVT	UNK	UNK		~ ()~~~In patient	891343032L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~4918123~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036933	04/08/1992	IA	33.0	33		U	11/06/1991	Pt devel red welts (5-10cm) & itching @ inject site p/recvd flu vax;									U	11/04/1991	11/05/1991	1		PVT	PVT	UNK	UNK		~ ()~~~In patient	891343033L	1						1	Injection site hypersensitivity; Injection site pain	FLUX~PFIZER\WYETH~4918123~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036934	04/08/1992	IA	37.0	37		U	11/06/1991	Pt devel red welts (5-10cm) & itching @ inject site p/receiving flu vax;									U	11/06/1991	11/06/1991	0		PVT	PVT	UNK	UNK		~ ()~~~In patient	891343034L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~4918123~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036935	04/08/1992	CT	22.0	22		F	11/06/1991	1 hr p/receiving flu vax pt exp allergic rxn associated w/hives & wheezing & a low grade fever (99.2); pt required ER/MD visit; pt also exp pain @ inject site lt deltoid; DPH given;				Y					Y	11/06/1991	11/06/1991	0		MIL	MIL	NONE	NONE	pt prev recvd 2 doses of flu vax; no allergies noted	~ ()~~~In patient	891343035L	1						1	Asthma; Hypersensitivity; Injection site pain; Pyrexia; Urticaria	FLUX~PFIZER\WYETH~4918177~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036936	04/08/1992	CT	23.0	23		M	11/06/1991	1 hr p/recvd flu vax pt exp local pain/adenopathy @ inject site lt deltoid; paresthesia to the fingers was also noted; pt required ER/MD visit; recovery occurred w/in 48 hrs;				Y					Y	11/06/1991	11/06/1991	0		MIL	MIL	NONE		pt had 2 prev doses of flu vax; unk if reactions occurred;	~ ()~~~In patient	891343036L	1						1	Injection site oedema; Injection site pain; Lymphadenopathy; Paraesthesia	FLUX~PFIZER\WYETH~4918177~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036937	04/08/1992	CT	20.0	20		M	11/06/1991	1 hr p/recvd flu vax pt devel swelling & redness @ inject site-lt deltoid; pt required ER/MD visit; recovery occurred w/in 24 hrs;				Y					Y	11/06/1991	11/06/1991	0		MIL	MIL	NONE		pt recvd 2 prev doses of flu vax; unk if rxns occurred;	~ ()~~~In patient	891343037L	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4918177~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036938	04/08/1992	CT	25.0	25		M	11/06/1991	1 hrs p/receiving the flu vax pt devel a 3mm induration w/inc warmth @ the deltoid inject site; t99.4; pt required ER/MD visit; recovery occurred w/in 24 hrs;				Y					Y	11/06/1991	11/06/1991	0		MIL	MIL	NONE		pt recvd 2 previous doses of flu vax; unk if rxn occurred;	~ ()~~~In patient	891343038L	1						1	Injection site mass; Pyrexia; Vasodilatation	FLUX~PFIZER\WYETH~4918177~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036939	04/08/1992	CA	4.0	3		M	11/14/1991	pt devel edema of the thigh (inject site) to twice its nl size, w/no evidence of erythema or fever w/in 5 days of flu vax; pt was treated w/DPH & ice packs were applied to area; 2 days later 12NOV91 thigh still appeared very swollen;									Y	11/05/1991	11/07/1991	2	x-rays revealed a proximal femur fractre;	PVT	PVT	NONE	NONE	hx hypoxic encephalopathy w/severe brain damage;	NONE~ ()~~~In patient	891346007L	1						1	Injection site oedema; Oedema	FLUX~PFIZER\WYETH~4918144~1~IM L~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036940	04/08/1992	WI	52.0	51		U	11/21/1991	Pt devel redness @ inject site p/receiving flu vax;									U	11/20/1991	11/21/1991	1		PVT	PVT	UNK	UNK		~ ()~~~In patient	891357028L	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4918135~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036941	04/08/1992	TX	47.0	47		F	11/19/1991	Pt exp pain @ inject site p/flu vax; this pain persisted & was present 1 mo p/vax;									U	10/18/1991				PVT	PVT	UNK	UNK		~ ()~~~In patient	891361001J	1						1	Injection site pain	FLUX~PFIZER\WYETH~4918120~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036942	04/08/1992	NJ				F	12/03/1991	Pt exp an allergic rxn p/recvd flu vax; addtl info has been requested;									U					OTH	OTH	UNK	UNK		~ ()~~~In patient	891364033J	1						1	Hypersensitivity	FLUX~PFIZER\WYETH~4918140~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036943	04/08/1992	CA	91.0			F	10/18/1991	pt devel a red, raised rash over trunk & arms 9 days p/recvd flu vax;				Y					Y	10/09/1991	10/18/1991	9		OTH	OTH	Lanoxin, Hydergine, Persantine, Metamucil;	NONE	pt has a hx cerebrovascular accident & is allergic to milk;	~ ()~~~In patient	891364004J	1						1	Rash maculo-papular	FLUX~PFIZER\WYETH~4918169~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036944	04/08/1992	CA	68.0	68		F	10/18/1991	Pt devel a red, raised rash over trunk & arms 9 days p/receiving flu vax;				Y					Y	10/09/1991	10/18/1991	9		OTH	OTH	Dilantin, Phenobarbital, Micronase, ASA	NONE	pt has diabetes mellitis & a hx of cerebrovascular accident	~ ()~~~In patient	891364005J	1						1	Rash maculo-papular	FLUX~PFIZER\WYETH~4918169~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036945	04/08/1992	CA	77.0	77		M	10/18/1991	Pt devel red, raised rash over trunk & arms 9 days p/recvd flu vax; in addition pt exp swelling, induration, & erythema @ inject site, w/swelling of the entire arm of inject extending to the hand;				Y					Y	10/09/1991	10/18/1991	9		OTH	OTH	Hydergine, DPH, vitamin supplement;	NONE	pt has alzheimer's disease & no known allergies;	~ ()~~~In patient	891364006J	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Oedema; Rash maculo-papular	FLUX~PFIZER\WYETH~4918169~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036946	04/08/1992	CA	53.0	53		F	10/18/1991	Pt devel scattered, red, raised rash over chest, abdomen, & arms 8 days p/recvd flu vax;				Y					Y	10/09/1991	10/17/1991	8		OTH	OTH	bactrim, Premarin, Amitriptyline, Haldol;	NONE	pt has huntington's disease & no known allergies	~ ()~~~In patient	891364007J	1						1	Rash maculo-papular	FLUX~PFIZER\WYETH~4918169~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036947	04/08/1992	FL				U	12/02/1991	pt devel a painful rash described as shingles w/in 2 days of receiving the flu vax;									N					PVT	PVT	UNK	UNK		~ ()~~~In patient	891364008L	1						1	Herpes zoster; Rash	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036948	04/08/1992	FL				U	12/02/1991	pt devel a painful rash described as shingles w/in 2 days of receiving flu vax;									N					PVT	PVT	UNK	UNK		~ ()~~~In patient	891364009L	1						1	Herpes zoster; Rash	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036949	04/08/1992	CO	84.0	84		F	12/02/1991	Pt devel facial erythema approx 48 hrs p/recvd flu vax; this adverse event has previously been reported to the USP;									U	10/24/1991	10/26/1991	2		OTH	OTH	UNK	UNK	pt has recvd flu vax for @ least the past 8 yrs; NKA:	~ ()~~~In patient	892003001H	1						1	Rash	FLUX~PFIZER\WYETH~4918147~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036950	04/08/1992	LA	38.0	38		F	12/04/1991	Pt devel flu-like sxs 1wk p/recvd flu vax; these sx persist as of 4DEC91;									N	10/15/1991	10/29/1991	14		PVT	PVT	UNK	UNK	UNK	~ ()~~~In patient	892003002H	1						1	Bronchitis; Dyspnoea; Influenza; Rhinitis	FLUX~PFIZER\WYETH~4918202~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036951	04/08/1992	KS				F	12/04/1991	Pt devel weakness in lt upper & lower arm p/recvd flu vax; weakness persists as of 4DEC91 although some imporvement was noted; MFR unable to obtain addtl info regarding this adverse event;									U	11/05/1991	11/05/1991	0		OTH	OTH	UNK	UNK		~ ()~~~In patient	892003003H	1						1	Myasthenic syndrome	FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036952	04/08/1992	MS	73.0	73		F	12/05/1991	pt devel weakness, nausea, & vomiting 3 wks p/flu vax; pt required 2 courses of ATB tx for this reaction;									Y	10/12/1991	11/05/1991	24		OTH	OTH	NONE	NONE	pt has degenrative arthritis	~ ()~~~In patient	892007007L	1						1	Asthenia; Nausea; Vomiting	FLUX~PFIZER\WYETH~4918138~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036953	04/08/1992	MS	84.0	84		F	12/05/1991	Pt exp sedation, chest congestion, & lt-sided pain 2 wks p/receiving flu vax; 3 days later 29OCT91 was noted to have a temp elevation; Cipro & Robitussin were given to treat the sx;									Y	10/12/1991	10/26/1991	14		OTH	OTH	NONE	UNK	pt has COPD & organic brain synd;	~ ()~~~In patient	892007008L	1						1	Lung disorder; Pain; Pyrexia; Somnolence	FLUX~PFIZER\WYETH~4918138~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036954	04/08/1992	MS	89.0	89		F	12/05/1991	Pt exp chest congestion, a cough, & temp elevation 3 days p/flu vax; 6 days later 30OCT91 pt exp nausea & vomiting; tx meds;									Y	10/21/1991	10/24/1991	3		OTH	OTH	NONE	NONE		~ ()~~~In patient	892007009L	1						1	Cough; Lung disorder; Nausea; Pyrexia; Vomiting	FLUX~PFIZER\WYETH~4918138~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036955	04/08/1992	MS	84.0	84		M	12/05/1991	pt exp lethargy 2 days p/recvd flu vax; 26OCT91 exp inc confusion & chest congstion w/a non productive cough; cough was also noted on 30OCT91 along w/elevation in temp;									Y	10/12/1991	10/14/1991	2		OTH	OTH	NONE	NONE	pt has chronic obstructive pulmonary disease	~ ()~~~In patient	892007010L	1						1	Confusional state; Cough; Lung disorder; Pyrexia; Somnolence	FLUX~PFIZER\WYETH~4918138~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036956	04/08/1992	NJ	32.0	31		F	12/10/1991	Pt devel intermittent paresthesias in both arms, hands, & fingers p/recvd flu vax; pt also exp soreness, achiness, & a heavy feeling in both arms as well as the shaking of 1 hand from time to time;				Y					N	10/23/1991				PVT	PVT	UNK	UNK		~ ()~~~In patient	892008013L	1						1	Hypertonia; Myasthenic syndrome; Paraesthesia	FLUX~PFIZER\WYETH~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036957	04/08/1992	NJ	57.0	57		F	12/10/1991	Pt devel paresthesias in the lt hand & fingers, a constant aching of the inject arm, & a tingling of the lower lip & tongue p/recvd flu vax;tingling of the lower lip subsequently abated;				Y					N	10/29/1991	10/30/1991	1		OTH	OTH	UNK	UNK	pt recvd 2 prev flu vax in the past; no reaction noted;	~ ()~~~In patient	892008014L	1						1	Myalgia; Paraesthesia; Paraesthesia oral	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0036958	04/08/1992	NJ	59.0	59		F	12/10/1991	Pt devel achiness in both arms shortly p/flu vax; subsequently devel intermittent cramps in both arms w/weakness in both arms & was unable to lift arms over head;									N	10/14/1991	10/14/1991	0		PVT	PVT	UNK	UNK	pt recvd 2 prev flu vax in the past; no rxn reported	~ ()~~~In patient	892008015L	1						1	Hypertonia; Hypokinesia; Myalgia; Myasthenic syndrome	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036959	04/08/1992	AL				U	12/10/1991	pt is on chemotherapy & exp a nosebleed p/receiving the flu vax;									U					PVT	PVT	unspecified chemotherapy	UNK		~ ()~~~In patient	92009032L	1						1	Epistaxis	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036960	04/08/1992	AL	82.0			F	12/10/1991	Pt is on chemotherapy & exp a nosebleed p/recvd flu vax;									U		11/24/1991			PVT	PVT	Unspecified chemotherapy	UNK		~ ()~~~In patient	892009033L	1						1	Epistaxis	FLUX~PFIZER\WYETH~4918153~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036961	04/08/1992	AL	81.0	81		U	12/10/1991	pt is on chemotherapy & exp a nosebleed p/receiving flu vax;									U	11/07/1991	11/08/1991	1		PVT	PVT	Unspecified chemotherapy	unk		~ ()~~~In patient	892009034L	1						1	Epistaxis	FLUX~PFIZER\WYETH~4918153~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036962	04/08/1992	AL	76.0	76		U	12/10/1991	Pt is on chemotherapy & exp a nosebleed p/receiving the flu vax;									U	11/08/1991	11/09/1991	1		PVT	PVT	Unspecified chemotherapy	UNK		~ ()~~~In patient	892009035L	1						1	Epistaxis	FLUX~PFIZER\WYETH~4918153~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036963	04/08/1992	AL	87.0	87		U	12/10/1991	Pt is on chemotherapy & exp a nosebleed p/receiving flu vax;									U	10/23/1991	11/01/1991	9		PVT	PVT	Unspecified chemotherpay	UNK		~ ()~~~In patient	892009036L	1						1	Epistaxis	FLUX~PFIZER\WYETH~4918181~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036964	04/08/1992	AL	72.0	72		U	12/10/1991	Pt is on chemotherapy & exp a nosebleed p/receiving flu vax;									U	10/25/1991	11/12/1991	18		PVT	PVT	Unspecifed chemotherpay	unk		~ ()~~~In patient	892009037L	1						1	Haemoptysis	FLUX~PFIZER\WYETH~4918181~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0036965	04/08/1992	PA	60.0			F	12/23/1991	Pt exp a h/a & a flare-up of rheumatoid arthritis p/recvd flu vax;									U	12/16/1991	12/16/1991	0		PVT	PVT	UNK	UNK	pt has debilitating rheumatoid arthritis	~ ()~~~In patient	892030002L	1						1	Condition aggravated; Headache; Hypertonia; Influenza; Pain; Pharyngitis; Rheumatoid arthritis	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0041234	04/14/1992	OK				F		Throat closed up, eyes swelled shut, couldn't breathe; happened 1-2 hrs p/vax;  would not provide details;			Y	Y					Y	11/01/1991	11/01/1991	0		UNK	UNK	NONE		NONE	~ ()~~~In patient	CO4201	1						1	Dyspnoea; Face oedema; Laryngospasm	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0041492	04/24/1992	GA	37.0	37		F	03/25/1992	Hospitalized for dizziness, slowed respiration, somnolence & h/a; tx w/Adrenlin & sterioids in low doses, then DPH;					Y	1			Y	10/25/1991	10/25/1991	0	Blood work/cultures-WNL	UNK	UNK	NONE	NONE	NONE	~ ()~~~In patient	CO4035	1						1	Dizziness; Headache; Hypoventilation; Somnolence	FLU3~CONNAUGHT LABORATORIES~1F21216~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0041509	04/24/1992	MD	64.0	64		M	04/22/1992	24DEC91 devel vigors & chills, felt anxious & weak; 25DEC91 rigors & chill & diaphoretic; unable to sleep; 30DEC91 EKG-atrial fibrillation; 4JAN92 very weak, seen in ER, arreflexia of legs & followed by neurologist for GBS;					Y	12			N	12/19/1991	12/24/1991	5		PVT	PVT	Cardizem, Lanoxin, Tetracycline, Voltaren, Quindex		PCN	~ ()~~~In patient		1						1	Anxiety; Asthenia; Atrial fibrillation; Chills; Guillain-Barre syndrome; Hyporeflexia; Insomnia; Paralysis	FLUX~PFIZER\WYETH~4918123~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0041591	04/29/1992	PA	71.0	71		M	04/16/1992	GBS hospitalized 9OCT91 eval & dx; tx plasmapheresis-responded well, but complicated by septic arthritis of rt knee;					Y	21			Y	09/10/1991	10/09/1991	29		PVT	PVT	diabetic on insulin	NONE	NONE	NA~ ()~~~In patient		1						1	Arthritis bacterial; Guillain-Barre syndrome	FLU3~PARKE-DAVIS~~6~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0041594	04/29/1992	OR	67.0	67		F	04/22/1992	GBS-plasmapharesis;			Y		Y		Y	Y	Y	11/21/1991	12/01/1991	10		PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Dysphagia; Guillain-Barre syndrome; Paralysis	FLU3~PARKE-DAVIS~01481P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0041657	04/30/1992	ME	70.0	70		M	04/20/1992	15NOV91 began having episodes of leg weakness; not felt to be prob in vax; change in sensation of lower extremties; gait disorder; shaking, shivering, spasms, twitch, swollen like feeling;				Y					N	11/01/1991	11/15/1991	14	BLood test; Ct Scan	PVT	PVT	Metoproloc, ASA	NONE	hypertension, inc blood sugar	NA~ ()~~~In patient	ME92007	1						1	Chills; Gait disturbance; Hypertonia; Muscle twitching; Myasthenic syndrome; Oedema; Paraesthesia; Tremor	FLUX~PFIZER\WYETH~4918131~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0041673	05/01/1992	CO				M	04/22/1992	Pt devel GBS p/recvd flu vax; additional info has been requested;									U					OTH	OTH	unk	unk	unk	~ ()~~~In patient	892114001J	1						1	Guillain-Barre syndrome	FLUX~PFIZER\WYETH~4918146~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0041707	05/04/1992	CT	47.0	47		F	04/29/1992	pt initially described having a sick feeling day p/vax; next day woke w/sore, red arm in area of inject; following day arm was red, swollen, sore, throbbing from shoulder to wrist; pt seen by MD;				Y					Y	10/24/1991	10/25/1991	1		PUB	PUB			NKA	NA~ ()~~~In patient	CT9111	1						1	Injection site hypersensitivity; Injection site pain; Malaise; Myalgia; Oedema; Vasodilatation	FLUX~PFIZER\WYETH~4918131~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~306905~UNK~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0041708	05/04/1992	CT	66.0	66		F	04/29/1992	pt c/o soreness, redness of affected arm; area felt warm to touch; pt applied cold compresses to area;									Y	10/22/1991	10/23/1991	1		PUB	PUB			hay fever, allergy to dust, cats, dogs	NA~ ()~~~In patient		1						1	Myalgia; Vasodilatation	FLUX~PFIZER\WYETH~4918131~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~306908~UNK~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0041862	05/11/1992	NE	68.0	67		M	04/30/1992	10 days p/flu vax felt poorly-tired; MD tests done found to be very anemic; dx rare acute myleofibrosis of the bone; gets blood transfusions every 2 wks; has also had ear infects & now swelling of the feet is very weak;	Y		Y		Y	4		Y	N	12/12/1991	12/22/1991	10		PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient	NE9212	1						1	Anaemia; Asthenia; Malaise; Myelofibrosis; Oedema peripheral; Otitis media	FLU3~CONNAUGHT LABORATORIES~1F21216~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0041926	05/13/1992	CA	51.0	51		F	05/01/1992	States 2 hrs p/ injection was dizzy, felt like passing out, shaky, weakness-followed w/ diarrhea. Pt states is sensitive to eggs, but not allergic.				Y					Y	12/03/1991	12/03/1991	0	CBC, Chem profile, electrolytes, stool analysis, Ova & parasites X3	PVT	PVT	Depo-Estradiol, Antivert, Valium, Lomotil,	none	TCN, PCN, EES, colitis, menopausal	~ ()~~~In patient		1						1	Asthenia; Diarrhoea; Dizziness; Tremor	FLU3~PARKE-DAVIS~~1~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0041963	05/15/1992	AZ	53.0	53		F	11/06/1991	immediatley p/recvd flu vax @ 1PM on 24OCT91, pain, pt had difficulty sleeping because of the pain & on 27OCT91 stopped aching but was still sore; nausea, 4-5 red spots, itch, pain under lt heart, shingles;				Y					N	10/24/1991	10/24/1991	0	NONE	OTH	PUB	PPD mantoux by Connaught lot# 232421;	NONE	allergic to PCN since childhood;	NA~ ()~~~In patient	CA9246	1						1	Chest pain; Herpes zoster; Insomnia; Myalgia; Nausea; Pain; Pruritus; Rash	FLUX~PFIZER\WYETH~4918140~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0041964	05/15/1992	CA	68.0	68		M	03/31/1992	pain @ site LA progressing to weakness, numbness, tingling LA, edema all extremities;				Y					N	11/06/1991	11/07/1991	1	Biopsy of site pending; pt referred to neurologist;	PUB	PUB	NONE	NONE	NONE	NA~ ()~~~In patient	CA9247	1						1	Injection site pain; Myasthenic syndrome; Oedema peripheral; Paraesthesia	FLUX~PFIZER\WYETH~4918169~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~285909~UNK~IM A~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0042008	05/15/1992	TX	62.0	62		F	05/04/1992	Extreme tenderness in area of flu shot; soreness & tenderness & later sweling by 11JAN92 arm mobility way down & discomfort very high; pt went to MD then referred to specialist 29JAN92 w/same sx as 11JAN92 & in between; tedonitis;								Y	Y	10/29/1991	10/30/1991	1	MRI	PVT	UNK	Levathroid; Anacin		Hypothyroidism offset by Levathroid & rxn to antib's given for recurring bladder infects; hypereosinophilia w/tx for hypothyroidism EOS levels went back to nl	NA~ ()~~~In patient		1						1	Hypokinesia; Injection site pain; Myalgia; Oedema; Pain; Tendon disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0037174	05/18/1992	FL	1.0			U	12/17/1991	pt exp cellulitis following DTP vax; unk if pt was hospitalized or treated w/ATB; unk if cultures were taken;				Y					U				NA	PUB	PUB	NA			NA~ ()~~~In patient	910235503	1						1	Cellulitis; Cellulitis	DTP~LEDERLE LABORATORIES~310964~UNK~IM L~~DTP (TRI-IMMUNOL)~1|HIBV~UNKNOWN MANUFACTURER~~UNK~L~~HIB (NO BRAND NAME)~1|OPV~PFIZER\WYETH~~UNK~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~1|DTP~LEDERLE LABORATORIES~310964~UNK~IM L~~DTP (TRI-IMMUNOL)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~L~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|OPV~PFIZER\WYETH~~UNK~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~2	USA	Emergency room visit	Influenza
0042021	05/18/1992	CA	62.0			M	03/26/1992	Pt recvd vax 7NOV91 & began exp tachycardia, exhaustion, weight loss of 25 lbs in 2 mos, low grade fever that subsided, & dry cough (persists); All lab test nl; pt has pre-existing stage 0 chronic lymphocytic leukemia;								Y	N	11/07/1991			CBC, Chem-20, GGTP, Febrile agglutinins, CXR, echo of heart, CAT Scan of chest; CAT Scan of abdomin & pelvis; hepatitis profile; bone marrow; EKG;	PVT	OTH	NONE	Stage 0 chronic lymphocytic leukemia		NA~ ()~~~In patient	920078001	1						1	Asthenia; Cough; Pyrexia; Tachycardia; Weight decreased	FLU3~LEDERLE LABORATORIES~312976~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Disabling	Influenza
0036912	05/20/1992	NJ	43.0	43		F	12/03/1991	pt exp an allergic reaction consisting of anxiety, SOB, & urticaria p/receiving flu vax;									Y	11/29/1991	12/01/1991	2		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	891364003J	1						2	Dyspnoea; Hypersensitivity; Urticaria; Anxiety; Dyspnoea; Hypersensitivity; Urticaria	FLUX~PFIZER\WYETH~4918140~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4918140~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0037209	05/20/1992	NJ	20.0			M	02/19/1992	pt devel numbness on rt side of body 24 hrs p/flu vax/DT/Meningococcal vax; pt was hospitalized due to adverse effect & was noted to be improving w/numbness currently localized to the rt leg;					Y				U	02/17/1992	02/18/1992	1		MIL	MIL	UNK	NONE	pt had surgery on rt hip related to chondromalacia @ age of 9;	~ ()~~~In patient	892051005L	1						1	Paraesthesia	DT~UNKNOWN MANUFACTURER~~UNK~~~DT ADSORBED (NO BRAND NAME)~1|FLU3~LEDERLE LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|MEN~UNKNOWN MANUFACTURER~~UNK~~~MENINGOCOCCAL (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0037210	05/20/1992	KS	68.0	68		F	02/19/1992	pt exp severe abd pain, dizziness & acute distress w/in 2 hrs recvd flu/pne-imune vax; adm to hosp w/dx of anaphylactoid reaction;				Y	Y	1			Y	10/01/1991	10/01/1991	0		PVT	OTH	UNK	UNK	UNK	~ ()~~~In patient	892078006L	1						1	Abdominal pain; Anaphylactoid reaction; Dizziness; Abdominal pain; Dizziness; Dyspnoea; Abdominal pain; Anaphylactoid reaction; Dizziness	FLUX~PFIZER\WYETH~4918139~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~297900~1~IM A~~PNEUMO (PNU-IMUNE)~1|FLUX~PFIZER\WYETH~4918139~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~PFIZER\WYETH~297900~1~A~~PNEUMO (PNU-IMUNE)~2|FLUX~PFIZER\WYETH~4918139~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|PPV~PFIZER\WYETH~297900~1~IM A~~PNEUMO (PNU-IMUNE)~3	USA	Hospitalisation	Influenza
0037211	05/20/1992	MA	44.0	44		F	01/10/1992	pt devel burning, pain, & a sensation of edema in hands, lower arms, & feet & lower legs approx 3 wks p/flu vax; pt described some tingling assoc w/reaction; pt did not exp loss of muscle movement or muscle paralysis; PE nl;				Y					N	11/22/1991	12/16/1991	24	rheumatoid factor-pos 965.6); nerve conduction studies-nl;	PVT	OTH	Naprosyn, Pred	NONE	pt has a hx of erythema nodosum;	~ ()~~~In patient	892021001L	1						1	Laboratory test abnormal; Oedema; Oedema peripheral; Pain; Paraesthesia	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0037212	05/20/1992	MI	92.0			F	01/10/1992	pt devel flu-like sx including fever 101, cough, & difficulty breathing approx 1 & 1/2 months p/flu vax; tx Ceclor;									Y	11/08/1991	12/28/1991	50		OTH	PUB	NONE	NONE		~ ()~~~In patient	892023001H	1						1	Cough; Dyspnoea; Influenza; Pyrexia	FLUX~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037213	05/20/1992	MA	38.0	38		F	12/10/1991	pt devel erythema, induration, swelling @ inject site p/recvd flu vax; in addition exp pain in arm & hand, numbness & tingling of hand, tetany of the fingers & palm of hand & dermatitis on back of the same hand;				Y					Y	12/01/1991	12/05/1991	4		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	892030001L	1						1	Hypoaesthesia; Injection site hypersensitivity; Injection site mass; Injection site oedema; Pain; Paraesthesia; Rash; Tetany	FLUX~PFIZER\WYETH~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0037214	05/20/1992	ME	19.0	19		F	01/17/1992	pt devel rt hemifacial spasm approx 7 wks p/flu vax; noted on 22NOV91 when drooping of rt eyelid occurred;  1 day later pt devel progressive involuntary rhythmical contraction of the rt face which cont; unable to vol open rt eye;				Y					N	10/01/1991	11/22/1991	52	2DEC91 MRI scn of brain-nl; Auditory brain responses-nl; Electorencephalogram-nl; electro-oculogram-nl; EMG of facial muscles-abn blink reflex; intact V-VII pathway; lesion involving central pontine pathways on the rt; brain stem myoclonus;	PVT	PVT	Slo-Bid, Cromolyn, Albuterol;	NONE	pt has a hx of asthma & PCn allergy (urticaria);	~ ()~~~In patient	892058003L	1						1	Brain stem syndrome; Dyskinesia; Eyelid ptosis; Hypoaesthesia; Hypokinesia; Influenza; Myoclonus; Neuropathy	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0037215	05/20/1992	VA	47.0			M	01/06/1992	pt recvd flu vax & exp pain in the lt upper arm, above inject site; pain was treated w/arthritis-strength aspirin w/no relief; Dolobid did not provide a favorable therapeutic response nor did corticosteroid therapy; pt ex limited mobility;				Y					U	10/31/1991	11/02/1991	2	14JAN91 x-ray lt shoulder nl	OTH	OTH	azmacort inhaler, Uniphyl	NONE	pt has a hx of asthma; no allergy to chicken eggs;	~ ()~~~In patient	892058004L	1						1	Arthritis; Hypokinesia; Injection site pain; Pain; Hypokinesia; Pain	FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0037216	05/20/1992	NJ	53.0	53		F	01/27/1992	pt recved flu vax in NOV91 & 2 months later 13JAN92 cancer screen (CA-125) test was performed w/result of 219; prev results for this pt has been in the range of 7-30; pt exp no apparent sequelae;									Y	11/11/1991	01/13/1992	63		PVT	PVT	NONE	NONE		~ ()~~~In patient	892058005L	1						1	Laboratory test abnormal	FLUX~PFIZER\WYETH~4918136~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037217	05/20/1992	PA	33.0			F	01/24/1992	preg pt was noted to have toxoplasmosis antibody titer present on routine testing p/recvd flu vax; antibody titers were confirmed on 2 subsequent occasions; however no inc was noted; pt is asymptomatic & the reporter felt these titers  low;									U	10/01/1991			toxoplasmosis antibody titer; 26DEC91 1:16-17; 10JAN92 1:16-17; 10JAN92 1:16-17;	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	892060001L	1						1	Laboratory test abnormal	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037218	05/20/1992	IA	49.0	49		F	01/20/1992	pt devel joint pain, myalgia, h/a, t103, vomiting, & nausea approx 1 wk p/flu vax; in addition noted a burning sensation in muscles, bones, eyes, & head; sx persisted for approx 2 wks during which time pt was unable to work & lost 11 lbs;				Y					Y	11/12/1991	11/19/1991	7		PUB	PVT	NONE	NONE	pt has allerg to PCN	~ ()~~~In patient	892063001L	1						1	Arthralgia; Bone pain; Eye pain; Headache; Myalgia; Pyrexia; Vomiting; Weight decreased	FLUX~PFIZER\WYETH~4918123~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0037219	05/20/1992	NC	35.0			M	01/24/1992	pt devel hepatitis p/recvd flu vax; this was assoc w/abd discomfort, bloating, & nausea; pt was noted to be improving;				Y					U	11/26/1991	12/17/1991	21	17DEC91 SGPT-1541; SGOT-946; total bilirubin-5.5; direct bilirubin 2.9; aklaline phosphatase 135; antibody/serology test were neg;	OTH	OTH	UNK	NONE		~ ()~~~In patient	892063002L	1						1	Alanine aminotransferase increased; Aspartate aminotransferase increased; Blood alkaline phosphatase increased; Generalised oedema; Hepatitis; Hepatomegaly; Hyperbilirubinaemia; Jaundice	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0037220	05/20/1992	MA	42.0	42		F	02/03/1992	pt devel poss brachial plexus neuropathy, causing pain in both arms p/recvd flu vax; pain began w/in hrs in lt arm (inject site) followed by pain in the rt arm 2 wks later; approx 1 month p/vax;				Y					N	01/03/1992	01/03/1992	0		PVT	OTH	NONE	NONE		NONE~ ()~~~In patient	892064002L	1						1	Injection site pain; Neuropathy; Pain	FLUX~PFIZER\WYETH~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0037221	05/20/1992	NC	32.0	32		F	02/04/1992	pt devel a maculopapular rash p/receiving flu vax; rash which was assoc w/pruritus began on the abdomen, spread to extremities, but did not involve the head;									Y	01/16/1992	01/22/1992	6		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	892064003L	1						1	Pruritus; Rash maculo-papular	FLUX~PFIZER\WYETH~4918221~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037222	05/20/1992	IA	25.0	25		M	01/10/1992	pt exp pruritus, erythema, swelling, & warmth @ inject site p/recvd flu vax; 3 days, swelling had incr to cover an area of 10 cm; rxn resolved p/1 & 1/2 wks;									Y	11/04/1991	11/05/1991	1		OTH	PVT	NONE	NONE	pt recvd flu vax the prev yr w/no reaction; allergic to tumbleweed;	NONE~ ()~~~In patient	892064004L	1						1	Injection site hypersensitivity; Injection site oedema; Oedema; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~4918123~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037223	05/20/1992	MI	101.0			F	01/10/1992	pt devel flu-like sx including fever 101, cough, difficulty breathing approx 1 & 1/2 mon p/recvd flu vax; tx Keflex;									Y	11/06/1991	12/21/1991	45		OTH	OTH	NONE	NONE		~ ()~~~In patient	892078003L	1						1	Cough; Dyspnoea; Influenza; Pyrexia	FLUX~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037224	05/20/1992	AK	56.0	56		F	02/18/1992	pt devel generalized hives in JAN92 p/recvd flu vax in OCT91; also devel cross-allergenicity to all animal proteins;				Y					N	10/18/1991	01/20/1992	94		PVT	PVT	NONE	NONE	pt recvd 4-5 prev flu vax on annual basis w/o incident; allergic to erythromycin & some laundry detergents;	~ ()~~~In patient	892078005L	1						1	Immune system disorder; Urticaria; Hypersensitivity; Pruritus; Urticaria	FLUX~PFIZER\WYETH~4918121~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4918121~6~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0037225	05/20/1992	NJ	70.0			F	02/25/1992	approx 1 month p/flu vax pt was noted to have elevations in SGOT, alkaline phos, & GGPT;  pt was asymptomatic; serology studies for Hep A & Hep B were pos;									U	09/23/1991	10/18/1991	25	18OCT91 SGOT 211; Hep A pos; Hep B surface antigen pos; Hep A-B panels; pos;	PVT	OTH	UNK	NONE	pt has taken erythromycin in past for acute URI; noted to have mild elevations of SGOT;	~ ()~~~In patient	892084001L	1						1	Aspartate aminotransferase increased; Blood alkaline phosphatase increased; Gamma-glutamyltransferase increased; Hepatitis; Infection	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0037226	05/20/1992	WI	40.0	40		F	03/17/1992	w/in 2 wks of flu vax pt devel numbness & progressive weakness of rt arm (inject site); rxn persisted untill mid JAN92; pt was unable to work for an unspecified length of time due to the severity of this weakness;									U	10/28/1991	11/11/1991	14		PVT	OTH	UNK	UNK		~ ()~~~In patient	892091002J	1						1	Myasthenic syndrome; Paraesthesia	FLUX~PFIZER\WYETH~4918135~2~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0042074	05/20/1992	PA	66.0	66		F	01/30/1992	Sharp shooting pain which seemed like an implosion in arm;  numbness occurred & is still present, initially in entire arm, now from elbow-wrist area;									N	10/01/1991	10/01/1991	0		PUB	PUB	NONE	NONE		NONE~ ()~~~In patient	PA9232	1						1	Pain; Paraesthesia	FLU3~PARKE-DAVIS~01481P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0049946	05/20/1992	AL	85.0	85		F	12/10/1991	pt on chemotherapy & radio therapy for cancer of the rectum exp nosebleed 11 days p/recvd flu vax; Neosynephrine nasal spray was prescribed to treat this adverse event;									Y	10/28/1991	11/07/1991	10	NONE	OTH	PUB	Maxzide, Levsinex, Lortab, Compazine, Lomotil, Tessalon, APAP, MOM, Atarax, Darvocet, hydrocortisone	diarrhea beginning w/radiation tx for ca	pt has hx of cancer of rectum, diverticulitis, colon resection, ureter obstruction, allergies to NSAIDS, diarrhea beginning w/radiationn tx for cancer;	NONE~ ()~~~In patient	892009032L	1						1	Epistaxis	FLUX~PFIZER\WYETH~4918153~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0042087	05/21/1992	MI	45.0	45		M	12/30/1991	w/in 1/2 hr pts lt hand & face became numb w/tingling-subsided in 1 hr somewhat but tingling reamined for several days;									Y	11/19/1991	11/19/1991	0	NONE	PUB	PUB	Ditropan	prev 2 days	spinal cord anomaly-subs surgery	NONE~ ()~~~In patient	MI92030	1						1	Paraesthesia	FLUX~PFIZER\WYETH~4918169~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0042124	05/21/1992	WA	55.0			F		Devel dermatopolymyositis 5 days p/flu vax; devel swollen face & rash;								Y			11/01/1991		elevated CPK; EMG; musclebiopsy-nl biopsy;	UNK	UNK			no hx of allergy to eggs;	~ ()~~~In patient		1						1	Blood creatine phosphokinase increased; Dermatomyositis; Face oedema; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0042126	05/21/1992	CO	45.0	45		M	05/07/1992	pt had a h/a was dizzy, woozy & nauseated;									Y	11/26/1991	11/27/1991	1		OTH	UNK				~ ()~~~In patient		1						1	Dizziness; Headache; Nausea	FLU3~CONNAUGHT LABORATORIES~1J21106~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0042130	05/21/1992	CO	46.0	46		M	05/07/1992	Day following vax, pt devel aching shoulder & neck, cough & upper respiratory congestion; site of inject was sore from lt elbow to lt ear; There was erythemia @ site of inject; pain in arm took approx 1 wk to subside;									Y	11/05/1991	11/06/1991	1		OTH	UNK	Soma, Singlet	NONE		~ ()~~~In patient		1						1	Cough; Injection site hypersensitivity; Injection site pain; Myalgia; Neck pain; Pain; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~1J21106~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0042185	05/26/1992	NY	52.0	52		F	12/15/1991	Generalized paresthesia of arms, hands, legs; sensation of skin irritation; resolved spontaneously p/2-3 wks of observation;  MD felt poss sensory neuritis;				Y					Y	11/04/1991	11/15/1991	11	neurology consultation; nerve conduction studies(nl) labs nl;	PVT	PVT	NONE	NONE	substance abuse-in recovery	NONE~ ()~~~In patient		1						1	Neuritis; Paraesthesia	FLU3~LEDERLE LABORATORIES~312981~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0037227	05/28/1992	NJ	57.0			F	11/20/1991	Pt vaxed on 11NOV91 & on 14NOV devel a spot on the leg which was itchy & raised; this disappeared but has had an itchy spot come & go each day x 5 days on various areas of the body;				Y					U	11/11/1991	11/14/1991	3	NA	PVT	OTH	NA	NA	NA	NONE~ ()~~~In patient	910218101	1						1	Pruritus; Rash	FLU3~LEDERLE LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0037228	05/28/1992	WI	1.5			F	11/18/1991	pt exp fever of 102 & vomiting 4 hrs p/vax which resolved w/in 12 hrs; seen in ER; tx w/APAP;				Y					Y	11/07/1991	11/07/1991	0	NA	PVT	PVT	NA		down's synd/av canal heart repair las yr	NA~ ()~~~In patient	910218201	1						1	Pyrexia; Vomiting	FLU3~LEDERLE LABORATORIES~314966~2~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0037229	05/28/1992	MA	82.0	82		F	11/20/1991	Approx 1 wk p/flu vax/pnu imune, pt exp redness swelling of hands, wrist, knees; dx acute polyarthritis; seen in ER 13NOV91; ESR 45; tx w/Clinoral; 19NOV still having pain, clinoral discontinued, txthen w/Darvocet & Ansaid; hospitalized;				Y	Y	6			N	10/23/1991	10/30/1991	7	Chem-nl CBC- high sed rate 45 otherwise nl glucose 186; ANA pending; lyme test neg; mono test neg; RA neg; RPR non reactive;	PVT	PVT	NA	erythema & edema of hand, PIP, joint kne	chronic atrial fibrillation; hiatus hernia w/gastroesophageal reflux; degenerative LS disease;	NONE~ ()~~~In patient	910224401	1						1	Arthritis; Condition aggravated; Hyperglycaemia; Oedema; Osteoarthritis; Pain; Red blood cell sedimentation rate increased; Vasodilatation	FLU3~LEDERLE LABORATORIES~312973~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|PPV~PFIZER\WYETH~298962~2~IM~~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0037230	05/28/1992	TN	39.0	39		F	11/27/1991	1 of 4 pts (out of 38 pts vaxed) who had an adverse event following vax; pt vaxed 8NOV91 devel a rash which started @ inject site & spread to rest of body; seen in ER 9NOV given DPH; seen again in ER 11NOV & given Cortisone IM; pt recover;				Y					Y	11/08/1991	11/09/1991	1	NA	PVT	PVT	NA	NONE	allergies; EES, Chloramycetin, Naparosyn;	NA~ ()~~~In patient	910224801	1						1	Injection site hypersensitivity; Rash	FLU3~LEDERLE LABORATORIES~310972~UNK~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0037231	05/28/1992	TN	56.0	56		F	11/27/1991	1 of 4 pts (out of 38 pts) vaxed who had an adverse event following vax; pt recvd vax 11NOV91 & devel a rash which started @ inject site & spread to rest of the body 12NOV; Seen in ER on 13NOV; given sterioids & Atarax;				Y					Y	11/11/1991	11/12/1991	1	NA	PVT	PVT	Zestaril	NONE	No known allergies;	NONE~ ()~~~In patient	910224802	1						1	Injection site hypersensitivity; Rash	FLU3~LEDERLE LABORATORIES~310972~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0037232	05/28/1992	TN	26.0			F	11/27/1991	1 of 4 pts (out of 38 pts vaxed) who had an adverse event following vax; pt had an inject site reaction; seen in ER; pt recovered;				Y					Y				NA	PVT	PVT	NA	NONE		~ ()~~~In patient	910224803	1						1	Injection site reaction	FLU3~LEDERLE LABORATORIES~310972~UNK~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0037233	05/28/1992	TN	28.0	28		F	11/27/1991	1 of 4 pts (out of 38 pts vaxed) who had an adverse event following vax; pt had local rxn w/redness, soreness & swelling; resolved w/in 24 hrs spontaneously; no known allergies;									Y	11/24/1991	11/24/1991	0	NA	PVT	PVT	NA	NONE	No known allergies;	NONE~ ()~~~In patient	910224804	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~LEDERLE LABORATORIES~310972~UNK~IM~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0037234	05/28/1992	AR	84.0	83		F	12/03/1991	1 of 3 elderly pts presented w/herpes zoster following vax; pt recvd vax & about 2 wks later presented to dermatologist w/pain & erythema; subsequently dx w/shingles & tx w/Pred; pt recovered;				Y					Y	09/11/1991	09/18/1991	7	routine dermatology tests;	PUB	PVT	Enalapril, probenecid; Darvocet	hypertens, deg joint dis, & diverticulit	hypertenssion, degenerative joint dis, Diverticulitis;	NA~ ()~~~In patient	910228401	1						1	Herpes zoster; Pain; Rash	FLU3~LEDERLE LABORATORIES~310975~2~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0037235	05/28/1992	AR	91.0			F	12/03/1991	1 of 3 pts who presented w/herpes zoster following vax; pt recvd vax & about a month later, presented in office w/c/o rash, low back pain & restlessness @ noc; pt recovered;				Y					Y	10/24/1991			routine PE;	PUB	PVT	Procardia XL, Digoxin, Synthroid;	hypertens, arteriosclerotic heart dis	hypertension, arteriosclerotic heart dis, peptic ulcer dis, s/p MI	NA~ ()~~~In patient	910228402	1						1	Back pain; Herpes zoster; Nervousness; Rash	FLU3~LEDERLE LABORATORIES~310975~2~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0037236	05/28/1992	AK				U	12/03/1991	1 of 3 pts who was vaxed between OCT91 & NOV91 presented w/herpes zoster approx 3 wks p/vax; no hx of herpes zoster;				Y					Y	10/11/1991			NA	PVT	PVT	blood pressure meds			NA~ ()~~~In patient	910228403	1						1	Herpes zoster	FLU3~LEDERLE LABORATORIES~310975~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0037237	05/28/1992	AK	46.0	46		M	12/18/1991	w/in 1-2 hrs p/vax pt devel flu-like synd, nausea & vertigo which lasted 7 days; fever & myalgia which lasted about 2 days; pt recovered;									Y	10/09/1991	10/09/1991	0	NA	OTH	OTH	NA	hemiplegia of several yrs duration	hx of cerebrovascular accident, w/hemipligia;	NONE~ ()~~~In patient	910235801	1						1	Influenza; Myalgia; Nausea; Pyrexia; Vertigo	FLU3~LEDERLE LABORATORIES~312976~1~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0037238	05/28/1992	NY	70.0			M	01/03/1992	4 days following flu vax pt admitted to hosp w/dehydration; devel low grade temp, malaise, dec appetite, disoriented; slowly improving; On many other meds MD feels pt had some encephalopathy;				Y					U	12/24/1991	12/28/1991	4	NA	OTH	OTH	Valium, Seconal, Codeine;	NA	NA	NA~ ()~~~In patient	920002601	1						1	Anorexia; Confusional state; Dehydration; Encephalopathy; Malaise; Pyrexia	FLU3~LEDERLE LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0037239	05/28/1992	NY	66.0			M	01/03/1992	consumer reports that 3 wks p/recvd flu vax, pt exp diarrhea which was not controlled w/imodium; prescribed Tetracycline & then Metronidazole;									U	12/02/1991	12/23/1991	21	NA	PVT	OTH	questran, Moduretic, Clinoril, Calan SR, Theragram		NKA- removal of 14 inches of lower bowel;	14NOV90 flu-immune;~ ()~~~In patient	920002701	1						1	Diarrhoea	FLU3~LEDERLE LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0037240	05/28/1992					F	01/06/1992	consumer reports that his wife exp an apparent allergic rxn consisting of eruption & itching; consumer would not provide addtl info;									U				NA	OTH	OTH	NA	NA	NA	NA~ ()~~~In patient	920004301	1						1	Hypersensitivity; Pruritus; Rash	FLU3~LEDERLE LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0042220	05/28/1992	WY	64.0	63		M	10/22/1991	No s/s of rxn known about; pt gurgled in sleep, pronounced dead @ hosp;	Y	10/21/1991							N	10/18/1991	10/21/1991	3	unk	OTH	PUB	UNK	denied any	denied allergy to eggs, mercury; heart & lungs diseases history;	NONE~ ()~~~In patient	WY9115	1						1	Apnoea	FLU3~LEDERLE LABORATORIES~314964~2~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Results in Death	Influenza
0042221	05/28/1992	WY	60.0	60		F	10/28/1991	Approx 10 min p/vax pt nearly fainted as entered residence; returned to site of flu clinic by then approx 15 mins post vax chilled & tremors; porgressed to swelling in throat, inc BP, dec pulse in 5 more minutes;			Y	Y					Y	10/25/1991	10/25/1991	0	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	WY9116	1						1	Bradycardia; Chills; Dizziness; Hypertension; Laryngospasm; Tremor	FLU3~LEDERLE LABORATORIES~314963~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Life Threatening	Influenza
0042223	05/28/1992	WY	32.0	32		F	11/08/1991	10 mins p/recvd vax, pt c/o feeling hot/cold flashes, weak, lightheaded & nauseated like walking on a cloud; described strange bitter taste in mouth w/in seconds of inject; given Adrenalin & observed another 20-30 mins;				Y					Y	11/07/1991	11/07/1991	0	NONE	OTH	PVT	NONE	denied	allergy PCN-rash, SOB, Codeine-rash under armpits, Darvon-same rxn, Talwin-swelling of hands & feet, nausea, bee stings	NONE~ ()~~~In patient	WY9118	1						1	Asthenia; Chills; Dizziness; Dysgeusia; Nausea; Vasodilatation	FLU3~LEDERLE LABORATORIES~314963~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0042334	06/01/1992	WA	82.0	82		M	04/17/1992	Legs bothered him had chills & fever; Also exp aches & poor appetites;									Y	11/16/1991	11/25/1991	9		PVT	PVT				~ ()~~~In patient	WA92708	1						1	Anorexia; Chills; Myalgia; Pain; Pyrexia	FLUX~PFIZER\WYETH~4918147~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0042335	06/01/1992	WA	80.0	80		F	04/17/1992	shingles; pt also exp aching leg & arm bones; poor appetites; unable to sleep all night; some form of shingles; infected hemorroid following flu vax;									Y	11/16/1991	11/25/1991	9		PVT	PVT	Pred, Perapimal (?), water pill, Cortisone		arthritis, heart	~ ()~~~In patient	WA92709	1						1	Anorectal disorder; Anorexia; Bone pain; Herpes zoster; Infection; Insomnia; Myalgia	FLUX~PFIZER\WYETH~4918147~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0042846	06/15/1992	GA	70.0	70		U	01/22/1992	Started fever 2 days p/Fluogen given; t105 x 4 days; pt to ER adm for 1 day; IV's given PMD advised no flu vax again;									Y	12/09/1991	12/11/1991	2		PUB	PUB	Lanoxin, HCTZ		Eczema, Heart failure, Hypertension	~ ()~~~In patient	GA92115	1						1	Pyrexia	FLU3~CONNAUGHT LABORATORIES~1F21222~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0817T~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0042853	06/15/1992	VA	45.0	44		F	06/05/1992	2 days p/recd Td/flu shot had an asthma attack on 10NOV91 & was hospitalized;				Y	Y				Y	11/08/1991	11/10/1991	2	EEG; Brain scan; LP;	OTH	PVT			pt has med hx of asthma attacks	NONE~ ()~~~In patient		1						1	Condition aggravated	FLU3~LEDERLE LABORATORIES~1F21206~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|TD~PFIZER\WYETH~4918050~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0042912	06/18/1992	FL				F	06/01/1992	pt recvd flu vax & devel transverse myelitis coincident w/its administration; pt is an incomplete quadriplegic as a result of the transverse myelitis; Wyeth-Ayerst is awaiting further info;								Y	N	11/05/1990				PVT	PVT	UNK	UNK	UNK	~ ()~~~In patient	892160001E	1						1	Myelitis; Quadriplegia	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0043061	06/19/1992		84.0			F		aching through abdomen, crampy in nature, followed by/or ocncurrent w/pain in both hips, weakness began w/pain & ocntinued thereafter; inability to get up & down as well since indicative of persistence of weakness; sciatica 2 wks later;								Y			11/04/1991		weakness was continues to be symmetric;	UNK	UNK			MD eval w/radiograph of the hips disclosed; no alternative explanation;	~ ()~~~In patient		1						1	Abdominal pain; Asthenia; Condition aggravated; Hypokinesia; Pain; Abdominal pain; Arthralgia; Asthenia; Neuralgia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Disabling	Influenza
0046212	06/23/1992	VA	1.7			M	01/30/1992	Consumer reports that 1 mo p/vax pt had sx of a cold; 10 days p/that exp stiff neck & could not move head; 10 days p/that exp 3 seizures; 13JAN92 hospitalized for 2 days; tx w/Dilantin; 20JAN92 hospitalized again 3 days for sz;					Y	2				11/26/1991			extensive testing @ hsp awaiting results;	PVT	UNK	NONE			~ ()~~~In patient	CO4133	1						1	Agitation; Convulsion; Encephalopathy; Hypertonia; Hypokinesia; Nuchal rigidity; Pharyngitis; Rhinitis	FLU3~LEDERLE LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation	Influenza
0043188	06/26/1992	NJ	40.0			M		post vax neuritis; post vax myositis lt deltoid muscle;								Y		10/01/1991	10/01/1991	0		UNK	UNK	NA	NA	NA	~ ()~~~In patient		1						1	Myositis; Neuritis	FLU3~CONNAUGHT LABORATORIES~1J21118~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0043242	06/29/1992	RI	75.0	75		F	10/31/1991	Urticaria for 3 days beginning poss 2 days p/flu vax recvd on 27OCT91;									Y	10/27/1991	10/29/1991	2	NA	PVT	PVT	NONE	NONE		~ ()~~~In patient		1						1	Urticaria	FLU3~PARKE-DAVIS~~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0043375	07/06/1992	MO	67.0	67		F	06/30/1992	About 10 days p/vax arms & legs became sore & felt swollen; limbs were sore to touch & arms were difficult to move; pt said skin felt like it would break it touched; sx caused emotional distress;									N	11/05/1991	11/15/1991	10		PUB	OTH			thyroid arthritis	~ ()~~~In patient		1						1	Affect lability; Hypokinesia; Myalgia; Oedema; Skin disorder; Arthralgia; Deafness; Dyspnoea; Hypokinesia; Myalgia; Myasthenic syndrome; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~1F21213~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~1F21213~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0043395	07/08/1992					U		pt recvd flu vax on 25OCT91 & the following day exp large red area that was warm around the site of inject; rxn improved each day, by fourth day p/vax, red area had faded & almost completely disappeared; MFR felt poss hypersensitive to vax;										10/25/1991	10/26/1991	1		UNK	UNK				~ ()~~~In patient		1						1	Hypersensitivity; Injection site hypersensitivity; Vasodilatation	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0043419	07/09/1992	AZ				U	12/18/1991	pt had near-syncopal episode x 2 accompanied by diaphoresis; no other etiology elucidated p/tx in hosp;											11/29/1991			UNK	UNK				~ ()~~~In patient		1						1	Dizziness; Hyperhidrosis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0043457	07/13/1992	MI	52.0	52		F	11/12/1991	c/o difficulty breathing; seen in ER told infected sinus; ? if related to vax; drain sinus, hard cough, pain in chest;				Y					Y	10/08/1991	10/28/1991	20		PUB	PUB		NONE	h/o past sinus infect	NONE~ ()~~~In patient	MI92067	1						1	Chest pain; Cough; Dyspnoea; Sinusitis	FLU3~CONNAUGHT LABORATORIES~1F21207~UNK~IM L~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0043458	07/13/1992	MI	70.0	70		F	11/13/1991	pt c/o sore throat, ear ache, cough, chills & weakness; there was no local soreness @ site; 24OCT91 pt seen in hosp ER Dr dx URI, pharyngitis & sore throat;				Y					Y	10/17/1991	10/24/1991	7	CBC-WBC10.7;	PUB	PUB	Mevacor, Vasotec	NONE	High BP, high cholesterol	NA~ ()~~~In patient	MI92068	1						1	Asthenia; Chills; Cough; Ear pain; Leukocytosis; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~1F21207~3~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0043459	07/13/1992	MI	62.0	62		M	11/13/1991	pt c/o cold, weakness, sinus headache & nausea off & on for 2 months; MD state this condition was part of pts chronic bronchitis;				Y					Y	10/22/1991	10/29/1991	7	NONE	PUB	PUB	Theodor, Hismal	chronic bronchitis	chronic bronchitis; hx of allergies dust, cigaret smoke etc;	NA~ ()~~~In patient	MI92069	1						1	Asthenia; Chills; Headache; Nausea	FLU3~CONNAUGHT LABORATORIES~1F21207~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0043460	07/13/1992	MI	69.0	69		F	11/13/1991	pt c/o stuffy head, h/a, stomach ache, but no soreness @ inject site; pt was seen by MD dx cold & high blood sugar;				Y					Y	10/24/1991	10/24/1991	0	blood sugar-300;	PUB	PUB	Micronase	diabetic	diabetic	1985 63 y/o exp rxn w/tetanus booster;~ ()~~~In patient	MI92070	1						1	Abdominal pain; Headache; Hyperglycaemia; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~1F21207~3~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0043461	07/13/1992	MI	56.0	56		F	11/12/1991	c/o chills, malaise, generalized weakness & fatigue, dec appetite, nausea; dx stomach virus;				Y					Y	10/31/1991	11/03/1991	3		PUB	UNK	Catapress, Mevacor, Chlorthalidone, Premarin;	hypertensive heart disease	allergic to PCN	~ ()~~~In patient	MI92071	1						1	Anorexia; Asthenia; Chills; Infection; Malaise; Nausea	FLU3~CONNAUGHT LABORATORIES~1F21207~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0043462	07/13/1992	MI	67.0	67		F	11/27/1991	pt recvd flu vax 5NOV91 & c/omuscle aches, n/v, coryza & low grade fever along w/generalized malaise & weakness;									U	11/05/1991	11/08/1991	3	NONE	UNK	UNK	Insulin, Vasontic, Nitrolid	diabetic, hypertensive heart dis	kidney disease, diabetic, hypertensive heart disease	NONE~ ()~~~In patient	MI92072	1						1	Asthenia; Malaise; Myalgia; Nausea; Pyrexia; Rhinitis; Vomiting	FLUX~UNKNOWN MANUFACTURER~~6~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0043466	07/13/1992	MI	70.0	70		M	01/07/1992	pt recvd flu vax & later noticed was exp SOB on exertion along w/sense of soreness in trachea; dx viral pneumonia;					Y				U	12/03/1991	12/12/1991	9		OTH	PUB	Nitrobid, Cardizem, Persantine;	coronary heart disease	coronary heart disease	~ ()~~~In patient	MI92076	1						1	Dyspnoea; Infection; Pharyngitis; Pneumonia	FLU3~CONNAUGHT LABORATORIES~1F21207~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0043467	07/13/1992	MI	67.0	67		M		Pt stated there was no noted discoloration, pain or swelling @ the site of inject; then a dull pain started w/no external signs; nerve injury & gave APAP;										12/03/1991	12/06/1991	3	NONE	PUB	PUB	Lanoxin, APAP, Syndroid;	radiation therapy on prostate;	cancer of prostate-38 radiation	NA~ ()~~~In patient	MI92077	1						1	Injection site pain; Neuropathy	FLU3~CONNAUGHT LABORATORIES~1F21207~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0043061	07/20/1992	DC	84.0			F		aching through abdomen, crampy in nature, followed by/or concurrent w/pain in both hips, weakness began w/pain & cont thereafter; sciatica about 2 wks later;								Y			11/04/1991		NONE	UNK	UNK	NONE		MD eval w/radiograph of the hips disclosed no alternative explanation;	~ ()~~~In patient		1						2	Abdominal pain; Asthenia; Condition aggravated; Hypokinesia; Pain; Abdominal pain; Arthralgia; Asthenia; Neuralgia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Disabling	Influenza
0045728	07/24/1992	NJ	70.0	70		F		Pt recvd vax 19OCT90 & devel swelling, redness & tenderness @ the inject sites; sx lasted for about 1 wk & then resolved; JAN91 pt devel polyarthralgia of the small joints & spread to involve large joints as well; rheumatoid arthritis;				Y					N	10/19/1990	10/22/1990	3	No relevant data;	PVT	PVT			hypertension	~ ()~~~In patient	WAES91070926	1						1	Arthralgia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Rheumatoid arthritis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~SC~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0045750	07/24/1992	NE	66.0	66		M		pt recvd pneumococcal vax 19NOV91 & that evening pt exp marked edema, erythema, pain & swelling in rt arm; t100 also exp severe pain & substantial edema to wrist; pt hospitalized for pain control;				Y	Y	3	Y		Y	11/19/1991	11/19/1991	0	No relevant data;	PVT	PVT	Synthroid			~ ()~~~In patient	WAES91110782	1						1	Arthralgia; Oedema; Osteoarthritis; Pain; Pyrexia; Rash	FLUX~PFIZER\WYETH~4918128~1~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1254T~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0045763	07/24/1992	PA	67.0	67		M		Pt recved pneumococcal vax on 2DEC91 & 3DEC91 devel a local reaction w/warmth, edema & erythema from the inject site to the elbow; had a swollen bursa, pain & fever in the arm; pt was seen by a MD & later recovered;				Y					Y	12/02/1991	12/03/1991	1	No relevant data;	PVT	PVT	Tagamet			~ ()~~~In patient	WAES91120442	1						1	Injection site hypersensitivity; Injection site oedema; Oedema; Pain; Vasodilatation	FLUX~PFIZER\WYETH~312981~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0817T~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0045764	07/24/1992	NE	38.0	38		M		pt recvd pneumococcal vax on 22NOV91 & a few hrs following vax devel swelling @ inject site; 24 hrs later entire outer aspect of the rt upper arm was swollen, red, warm & very uncomfortable; tx w/unspecified antihistamines & ice packs;									Y	11/22/1991	11/22/1991	0	No relevant data;	OTH	OTH				~ ()~~~In patient	WAES91120655	1						1	Injection site oedema; Oedema; Pain; Vasodilatation	FLUX~PFIZER\WYETH~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0818T~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0045766	07/24/1992	NE	48.0	48		M		pt recvd 2nd dose of pneumococcal vax on 21NOV91 & on 22NOV92 devel fluid retention for the next 2 to 3 days; pt recovered; no further details were provided;									Y	11/21/1991	11/21/1991	0	no relevant data;	PVT	PVT	Prednisone, Lasix, Minipress, Tenormin, Loniten, Procardia, Imuran, Cyclosporin;		Nephritis; transplant, kidney	~ ()~~~In patient	WAES92010272	1						1	Generalised oedema	FLUX~PFIZER\WYETH~4918128~4~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1254T~2~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0043887	08/03/1992	CO	60.0	60		F		pt exp back pain, tingling & numbness, burning sensations in soles;strength weakened; gait unsteady; absent reflexes, dysesthesia, GBS; dx mid thoracic disc; aching, BP160/95; facial cellulitis					Y					10/06/1990	12/25/1990	80		UNK	UNK	Pred, Premarin, Calcium		Hysterectomy in 1973, MI disease	~ ()~~~In patient		1						1	Cellulitis; Chest pain; Gait disturbance; Guillain-Barre syndrome; Hyporeflexia; Myasthenic syndrome; Pain; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0043888	08/03/1992	MI	35.0	35		F	07/28/1992	Guillain-Barre synd;			Y	Y	Y	17	Y	Y	Y	10/19/1990	10/30/1990	11	EMG, LP;	OTH	OTH		sore throat day of vax	NONE	~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0043953	08/06/1992		62.0			F	07/08/1992	cerebrovascular accident (lt hemisphere) in pt, 10 days p/vax w/fluvirin; pt was vaxed on 14OCT91 & died 25OCT91; no other clinical info available;	Y	10/25/1991							N	10/14/1991	10/25/1991	11	NA	OTH	OTH	NA			NA~ ()~~~In patient	920262501	1						1	Cerebrovascular accident	FLU3~LEDERLE LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Results in Death	Influenza
0045652	08/06/1992	AZ				F	04/01/1992	pt recvd flu vax & devel leg numbness & difficulty walking; now required a walker;									U					OTH	OTH	UNK	UNK		~ ()~~~In patient	892130005L	1						1	Gait disturbance; Paraesthesia	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0045653	08/06/1992	CT	51.0	51		F	05/07/1992	pt recvd flu vax & w/in 1/2 hr devel erythema, induration, & pruritus @ the site of inject; next day devel a fever & intense arthralgias, similar to serum sickness reaction; 28MAY92 pt cont to exp myalgias/arthralgias;									N	11/01/1991	11/01/1991	0	WBC 7.5; CPK 67;	PVT	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	892139020L	1						1	Arthralgia; Injection site hypersensitivity; Injection site mass; Myalgia; Pruritus; Pyrexia; Serum sickness	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0033304	08/07/1992	IA	65.0	65		F	04/01/1991	pt devel sx of labyrinthitis on 3rd day following vax; pt also recvd flu vax; required ER/MD visit; pt recovered approx p/3wks;				Y					Y	12/08/1990	12/11/1990	3	EKG; Chem profile; CBC	PVT	PVT	Verapamil	NONE	hx of breast cancer w/no metastasis-1974;	pt had no previous vaccinations;~ ()~~~In patient	910070001	1						2	Vestibular disorder	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~PFIZER\WYETH~256949~UNK~IM~LA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0037174	08/07/1992	FL	1.0			U	12/17/1991	pt exp cellulitis following DTP vax; unk it pt was hospitalized or treated w/ATB: unk if cultures were taken;				Y					U				NA	PUB	PUB	NA			~ ()~~~In patient	910235503	1						2	Cellulitis; Cellulitis	DTP~LEDERLE LABORATORIES~310964~UNK~IM L~~DTP (TRI-IMMUNOL)~1|HIBV~UNKNOWN MANUFACTURER~~UNK~L~~HIB (NO BRAND NAME)~1|OPV~PFIZER\WYETH~~UNK~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~1|DTP~LEDERLE LABORATORIES~310964~UNK~IM L~~DTP (TRI-IMMUNOL)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~L~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|OPV~PFIZER\WYETH~~UNK~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~2	USA	Emergency room visit	Influenza
0037210	08/07/1992	KS	68.0	68		F	12/19/1991	w/in 2 hrs pos vax, pt exp severe abdominal pain, dizziness & acute distress; admit into hosp; dx acute anaphylactoid reaction;					Y				Y	10/01/1991	10/01/1991	0	hospital discharge summary available;	PVT	OTH	NA			NA~ ()~~~In patient	910237901	1						3	Abdominal pain; Anaphylactoid reaction; Dizziness; Abdominal pain; Dizziness; Dyspnoea; Abdominal pain; Anaphylactoid reaction; Dizziness	FLUX~PFIZER\WYETH~4918139~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~297900~1~IM A~~PNEUMO (PNU-IMUNE)~1|FLUX~PFIZER\WYETH~4918139~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~PFIZER\WYETH~297900~1~A~~PNEUMO (PNU-IMUNE)~2|FLUX~PFIZER\WYETH~4918139~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|PPV~PFIZER\WYETH~297900~1~IM A~~PNEUMO (PNU-IMUNE)~3	USA	Hospitalisation	Influenza
0043970	08/07/1992	NC	78.0	78		F		progressive LE weakness, GBS;	Y	03/16/1991							N	10/11/1990	11/15/1990	35	many, including LP, EMG;	PVT	UNK		NONE		~ ()~~~In patient		1						1	Guillain-Barre syndrome; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~0F11208~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0045671	08/07/1992	WA	13.0			M	10/18/1991	1 of 2 pts who recvd vax w/in 48 hrs devel fever 101, h/a & an inject site reaction (@ pnu-imune site); inject site reaction described as localized redness & soreness;									U	10/16/1991	10/18/1991	2	NONE	PUB	PUB	NONE	NONE	Muscular dystrophy	NA~ ()~~~In patient	910200601	1						1	Headache; Injection site hypersensitivity; Injection site pain; Pyrexia	FLUX~PFIZER\WYETH~4918153~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~300911~1~SC~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0045672	08/07/1992	WA	15.0			M	10/18/1991	1 of 2 pts who recvd vax w/in 48 hrs devel fever of 101, h/a, & inject site reaction (@ Pnu-imune site); inject site reaction described as localized redness & soreness;									U	10/16/1991	10/18/1991	2	NONE	PUB	PUB	NONE	NONE	muscular dystrophy	NA~ ()~~~In patient	910200602	1						1	Headache; Injection site hypersensitivity; Injection site pain; Pyrexia	FLUX~PFIZER\WYETH~4918153~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~300911~1~SC~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0045680	08/07/1992	GA	65.0	65		F	12/23/1991	pt devel a large swollen red arm following pnu-immune/fluogen; later also devel some red streaks from inject site;									Y	12/18/1991	12/20/1991	2	NA	PVT	PVT	NA	pt currently undergoing treatment for CA	cancer of breast; allergic to codeine & PNC;	NONE~ ()~~~In patient	910240301	1						1	Oedema; Skin striae; Vasodilatation	FLU3~PARKE-DAVIS~~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~314914~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0045681	08/07/1992	GA	66.0	66		F	12/23/1991	pt recvd pnu-imune/fluogen 9DEC91 & 10DEC fever 101, red, area; on 11DEC fever 99.1, nausea, legs aching, somnolence & red lump @ inject site w/streak (1) inside arm; 12DEC nausea persist w/dizziness & weakness; local rxn size of baseball;				Y					Y	12/09/1991	12/10/1991	1	NA	PVT	PVT	Tagamet, Vitamin			NONE~ ()~~~In patient	910240302	1						1	Asthenia; Dizziness; Injection site hypersensitivity; Injection site mass; Myalgia; Pyrexia; Skin striae; Somnolence	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~314914~1~IM A~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0044074	08/10/1992	CA	91.0	91		F	02/19/1992	pt had a massive heart attack;	Y	11/21/1991		Y					N	11/14/1991	11/21/1991	7	UNK	PVT	PUB	UNK	NONE	UNK	UNK~ ()~~~In patient	CA9277	1						1	Arrhythmia; Cardiac arrest; Dyspnoea; Hypotension; Myocardial infarction; Pulmonary oedema; Shock; Ventricular tachycardia	FLUX~PFIZER\WYETH~4918130~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0044149	08/13/1992	NJ	56.0	56		F	08/07/1992	Had flu inject OCT90 around thanksgiving weakness of lower extremities; unable to ambulate-hospitalized x 10 days; dx demyeletory nerve disease;				Y	Y	10		Y	N	10/01/1990	11/25/1990	55		OTH	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Hypokinesia; Myasthenic syndrome; Neuropathy	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0044213	08/18/1992	PA	77.0	77		F	01/09/1991	Numbenss of limps-progressing to paresis; loss of strength in arms; pos lyme titer to date;				Y	Y	90			N	10/17/1990	10/22/1990	5	ESR94; spinal tap nl; chronic inflammatory demyelinatory neuropathy;	PVT	PVT	Synthroid-thyroid replacement	bronchitis <2 wks;	paresis lt lower extremity due to polio as young child	~ ()~~~In patient		1						1	Asthenia; Laboratory test abnormal; Neuropathy; Paraesthesia; Paralysis; Red blood cell sedimentation rate increased	FLUX~PFIZER\WYETH~4908190~5~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0044214	08/18/1992	MN	54.0			M	12/20/1990	pt exp numbness in hands 19NOV90; sharp pain in lt shoulder 22NOV90 @ noon; thigh pain Thursday in evening; Seen by MD 23NOV90;					Y	19			Y	11/07/1990	11/22/1990	15		OTH	PVT	UNK	NONE	hayfever-seasonal	NONE~ ()~~~In patient		1						1	Pain; Paraesthesia	FLUX~PFIZER\WYETH~4908198~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0044215	08/18/1992	NY	75.0	75		M	12/19/1990	Muscular weakness, fever, weak, back pain x 6 days; anorexia, loss of reflexes; conduction-block; Guillain-Barre-type inflammatory polyneuropathies;					Y	10			Y	10/15/1990	11/01/1990	17	EMG	PVT	PVT		NONE	arthralgias- pos ANA	~ ()~~~In patient		1						1	Anorexia; Back pain; Guillain-Barre syndrome; Hyporeflexia; Laboratory test abnormal; Myasthenic syndrome; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~0F11227~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0044216	08/18/1992	CA	34.0	34		M		12DEC90 devel elevated weakness which began in feet & moved upwards; unable to walk, drops things; mild URI sx x 1 wk PTA; IGM-17DEC abn consistent w/GBS; plasmaphoresis x 5 exchgs;				Y	Y	18	Y		N	11/30/1990	12/12/1990	12	IGM-17DEC90-abn consistent w/GBS;	MIL	UNK	Given 30NOV92 PPD Connaught Labs lot# 231712;and Bicyllin Wyth Lot# 2891626;		hos of pos PPD;	~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome; Hypokinesia; Laboratory test abnormal; Pharyngitis	ADEN~PFIZER\WYETH~4888220~UNK~~~ADENOVIRUS (TYPE 7, NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~0511019~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~CONNAUGHT LABORATORIES~0D21085~UNK~~~MENINGOCOCCAL (MENOMUNE)~1|MER~MERCK & CO. INC.~0302R~UNK~~~MEASLES + RUBELLA (MR-VAX II)~1|MU~MERCK & CO. INC.~02106~UNK~~~MUMPS (MUMPSVAX I)~1|OPV~PFIZER\WYETH~0611C~UNK~~~POLIO VIRUS, ORAL (ORIMUNE)~1|TD~CONNAUGHT LABORATORIES~9L11011~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0044217	08/18/1992	NC	61.0	61		M	08/12/1992	Guillain-Barre synd; unusual pins & needle feeling along the midline in front; band of tightness around abdomen; numbness; areflexic proximal strength is 4/5; dysesthesias; urinary retention; hypotonic urinary bladder;					Y	28			Y	09/27/1990	12/10/1990	74	white blood count 13.9 w/81SEGS, 3 Bands, 8 lymphocytes, 3 monocytes, 1 Eosinophil; Hemoglobin was 13.8; hematocrit 40.8 Electrolytes were remarkable for NA of 133; total protein of 5.8;	PVT	PVT		COPD, hypothyroid, urolithiasis	COPD, hypothyroid, urolithiasis	~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome; Hyporeflexia; Leukocytosis; Neck pain; Neuropathy; Paraesthesia; Paralysis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0044223	08/18/1992	NC	72.0			F	08/12/1992	Guillain-Barre synd;					Y				U	10/10/1990	12/06/1990	57		PVT	PVT			arrythmias	~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0044506	08/24/1992	OK	19.0			M		Pt hospitalized on 7NOV90 & d/c 22NOV90; pt devel weakness w/inability to walk; had a weakness of the pharyngeal muscles in that voice has a nasal quality & has difficulty in swallowing food; had numbness; absent reflexes; polyneuritis;GBS			Y		Y	14			Y	09/10/1990	11/05/1990	56	CSF Protein 250%; NCV's in the 30's;	PUB	PUB				~ ()~~~In patient		1						1	Asthenia; CSF test abnormal; Dysphagia; Guillain-Barre syndrome; Hyporeflexia; Myasthenic syndrome; Neuritis; Paraesthesia	FLUX~PFIZER\WYETH~4908179~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0046086	08/27/1992	OH				F	04/09/1992	pt recvd flu vax in SEP or OCT90; w/in 1 day of vax pt devel shoulder pain; also devel various rashes, the last of which believes is shingles; in addtion pt was dx w/degenerative arthritis which was attributed to flu vax;									U					PUB	OTH	NONE	UNK		~ ()~~~In patient	892132006L	1						1	Acne; Arthritis; Herpes zoster; Pain; Rash	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0044800	09/10/1992	MA	40.0	40		F	09/06/1992	1DEC91 h/a, photophobia; 7DEC91 paralysis of rt pupil, adie's pupil; pt seen in ER for unequal pupils to r/o aneurysm; inc chemosis; 20DEC91 impaired central vision, bilat, retinas showed mutiple serous detachments, bilat opic disc edema;				Y	Y	3		Y	Y	11/21/1991	12/01/1991	10	inflammation resolved showed multiple bilat retinal defects;	PVT	PVT	NONE prior to onset began Nafaralin 1DEc & 14DEc d/c	NONE	NONE	NONE~ ()~~~In patient		1						1	Chorioretinitis; Conjunctivitis; Optic neuritis; Photophobia; Pupillary disorder; Retinal detachment; Retinal disorder; Visual field defect	FLUX~PFIZER\WYETH~4918152~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~PASTEUR MERIEUX INST.~C1150~1~SC A~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MEN~CONNAUGHT LABORATORIES~0M21074~1~SC A~~MENINGOCOCCAL (MENOMUNE)~1	USA	Hospitalisation,Disabling	Influenza
0044936	09/14/1992	HI	80.0	80		M	09/03/1992	w/in about 6-8 hrs of vax devel h/a; by next day h/a worse; sl confused, fever, stiff neck; spinal tap, CSF  WBC 460, Polys 97%, Protein 210;					Y	7			Y	08/18/1992	08/18/1992	0	spinal tpa, CSF-460WBC, 97% Polys, Protein 210; culture;	PVT	UNK		NONE	NO Known allergies;	~ ()~~~In patient		1						1	Blood urea increased; CSF test abnormal; Confusional state; Hyperglycaemia; Hypoproteinaemia; Nuchal rigidity; Red blood cell sedimentation rate increased; Respiratory alkalosis	FLU3~PARKE-DAVIS~01572P~7+~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0038125	09/15/1992	AZ	60.0	60		F	02/18/1992	pt felt gushing sensation in chest & neck following vax; sx persisted next 4 days; tongue felt thicker; on 5th day, leg felt swollen & twisted to the left; by evening, face twisted to the left; seen in ER; dx bell's palsy;				Y					U	11/20/1991	11/20/1991	0	26NOV91 audio-NR (R); ENT referral	PUB	OTH	one-a-day vitamins w/iron	NONE	diabetes-diet controlled	pt became ill w/flu-like sx p/receiving flu vax in past; pt's daughter;~ ()~~~In patient	920031801	1						2	Facial palsy; Oedema; Tongue oedema	FLU3~LEDERLE LABORATORIES~314963~UNK~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~2	USA	Emergency room visit	Influenza
0038793	09/15/1992	AZ	52.0	52		F	01/17/1992	pt vax on 14NOV91 & 20DEC began exp lt facial pain & enlarged nodes; pain inc over next wk; dx as bells palsy; hearing loss noted; treated w/Zovirax & pred;				Y					U	11/14/1991	12/20/1991	36	neurological-muscles exam, checked hearing;	PUB	OTH	NONE	NONE	allergic to PCN, Iodine, Oral polio & duck eggs; one kidney; consumer reports sx dx as bells palsy 30DEC91; treated w/Zovirax & pred; hypertension treated w/Betaxolol;	pt had an adverse event in 1966 @ 27 w/first OPV;~ ()~~~In patient	920015201	1						2	Deafness; Dysphagia; Facial palsy; Headache; Lymphadenopathy; Pain; Deafness; Facial palsy; Lymphadenopathy; Pain	FLU3~LEDERLE LABORATORIES~314963~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|FLU3~LEDERLE LABORATORIES~314963~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~2	USA	Emergency room visit	Influenza
0039023	09/15/1992	AZ	34.0	34		F	02/18/1992	pt recvd vax 7NOV91 & approx 16DEC devel numbness & dec movements in the rt side of face; seen in ER-dx probable bell's palsy; ENT referral; pt has hx of Bell's Palsy in 1975 w/more severe onset;				Y					U	11/07/1991	12/16/1991	39	ENT referral;	OTH	OTH	NONE	NONE	prev hx of Bell's Palsy in 1975 w/more severe onset;	NONE~ ()~~~In patient	920031802	1						2	Ageusia; Facial palsy; Hypokinesia; Paraesthesia; Facial palsy; Hypokinesia; Paraesthesia	FLU3~LEDERLE LABORATORIES~314963~UNK~~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|FLU3~LEDERLE LABORATORIES~314963~UNK~IM~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~2	USA	Emergency room visit	Influenza
0045017	09/15/1992	CO	50.0	50		F	12/20/1990	onset paresthesia & numbness in feet 24NOV; devel weakness & hospitalized 6DEC90; dx GBS now recovering;			Y		Y	11			Y	11/08/1990	11/24/1990	16	CSF protein 216; WBC1;	UNK	UNK		NONE	NONE	~ ()~~~In patient	CO9293	1						1	Asthenia; Guillain-Barre syndrome; Paraesthesia	FLUX~PFIZER\WYETH~4908204~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0046087	09/15/1992	MO	76.0	75		F	12/09/1991	pt c/o blurred vision on 2 occasions; once in 1990 & once in 1991 p/receiving flu-immune; seen by ophthalmologists-dx: early cataracts; pt is type II diabetic;				Y					N	10/25/1991	10/25/1991	0	HGB ALC=6.2;	PVT	PVT	Micronase, synthroid	Type II diabetic, early cataracts	hypothyroidism; essential hypertension; pt recvd flu-immune 312973 prev yr 2NOV90;	pt exp blurred vision @ 75 y/o w/flu imune #1 dose;~ ()~~~In patient	910232801	1						1	Amblyopia	FLU3~LEDERLE LABORATORIES~312973~2~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0046089	09/15/1992	IN				M	02/12/1992	consumer reports that brother exp tachycardia 1 wk following vax; same occurrence last year;									U				NA	OTH	OTH	NA	NA	NA	NA~ ()~~~In patient	920027201	1						1	Tachycardia	FLU3~LEDERLE LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0046092	09/15/1992	IN				M	04/07/1992	w/in 24 hrs post vax, pt exp systemic urticaria; pt has no prior hx of reactions to other flu shots; treated w/Medrol pack; urticaria still persisting 5 months p/vax;				Y					U	11/07/1991	11/08/1991	1	NA	PVT	PVT	Synthroid, Diazide, Monoprel;	healthy	hypertension	none~ ()~~~In patient	920106401	1						1	Urticaria	FLU3~LEDERLE LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0043375	09/18/1992	MO	67.0	67		F	09/01/1992	10 days p/vax severe pain in lt hand; 2 wks in rt hand; diffiuclt to walk; hair loss, pain, lost strength in arms; ankles to knees suddenly started swelling & turning blue; flesh hurts, lost hearing, ringing & roaring in ears, feels sick									N	11/08/1991	11/18/1991	10	doplar, lyme disease, overy test, bone scan, neroes muscles;	PUB	PUB	Naprac, Pred, APAP, Lanoxin, Premarin	NONE	heart thyroid	~ ()~~~In patient	MO92090	1						2	Affect lability; Hypokinesia; Myalgia; Oedema; Skin disorder; Arthralgia; Deafness; Dyspnoea; Hypokinesia; Myalgia; Myasthenic syndrome; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~1F21213~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~1F21213~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0045873	09/28/1992	CO	34.0	34		F	09/27/1992	swelling, redness;				Y	Y					09/16/1992	09/17/1992	1		MIL	MIL		NONE	allergies pollen, dust, mites, molds, stadol, Cleocin, Sulfa; HTN	~ ()~~~In patient		1						1	Oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~2J31137~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0045970	10/01/1992	OH	1.6	1	.6	F	09/28/1992	this pt began w/screaming uncontrollably on 25SEP92; pt lies listless since, refuses to smile, acts sore; exam: shows listless w/devel delay & LOM;										09/23/1992	09/24/1992	1		PVT	PVT		no x/cerebral	palsy, BPD, cerebral palsy	~ ()~~~In patient		1						1	Agitation; Crying; Malaise; Otitis media; Pain	DTP~LEDERLE LABORATORIES~332986~4~~RA~DTP (TRI-IMMUNOL)~1|FLU3~CONNAUGHT LABORATORIES~2F31132~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|OPV~PFIZER\WYETH~324948~UNK~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~1	USA		Influenza
0046114	10/13/1992	LA	67.0	67		F		about 2 wks p/shot woke up 2AM w/severe pain lower back & rt leg to knee 16NOV91; pt went to ER & adm to hosp seen by bone & joint specialist; nerve problem, glucose of 136; meralgia paresthetica; pneumonia, Hgb 11.5, WBC 4,500;				Y	Y	7	Y	Y	N	11/01/1991	11/16/1991	15	HGB-11.5; HCT 35.4, RDW 16.1;	PUB	PUB		NONE	NONE	~ ()~~~In patient	LA921004	1						1	Back pain; Hyperaesthesia; Hyperglycaemia; Hypochromic anaemia; Laboratory test abnormal; Leukopenia; Neuropathy; Pneumonia	FLU3~CONNAUGHT LABORATORIES~1F21219~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0046176	10/13/1992	NJ	71.0	71		M	10/07/1992	erythema & swelling medical left arm-axilla to wrist; pt applied heat-MD recommended observe;				Y					Y	09/22/1992	09/23/1992	1		PVT	PVT	Lanoxin, Norpace CCR, ASA, Questran, Prozac	NONE	ASHD, Hypertension, Atrial fibrillation	NA~ ()~~~In patient		1						1	Oedema; Rash	FLU3~CONNAUGHT LABORATORIES~2F31142~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1301T~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0046207	10/13/1992	MT	42.0	42		F	10/09/1992	localized 5cm diameter erythema, skin temp hot @ site; no induration, no pain, moderate swelling, no systemic effects; 2cm diameter ecchymosis @ inject site, no other s&s;									Y	10/06/1992	10/08/1992	2	NONE	OTH	OTH	Premarin	NONE	Codeine	NONE~ ()~~~In patient		1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLUX~PFIZER\WYETH~4928145~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046210	10/13/1992	GA	42.0	42		F	10/07/1992	both lower arms, neck broke out w/flat red area; went to pharmacy & MD prescribed a DPH; also red, hot area @ vax site;									Y	10/05/1992	10/05/1992	0	NONE	PVT	PVT	Vitamins comples F, Vit C, Estroderm patch, Lotensin, Hydrochlotized	NONE	hypertension	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Rash; Vasodilatation	FLUX~PFIZER\WYETH~4928133~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046211	10/13/1992	GA	40.0	40		M	10/07/1992	broke out flat red area over chest & stomach; no itching; gone next morning;									Y	10/05/1992	10/05/1992	0	NONE	PVT	PVT	Vasotec	NONE	Hypertension	NA~ ()~~~In patient		1						1	Rash	FLUX~PFIZER\WYETH~4928133~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046230	10/19/1992	MI				U	10/07/1992	pt recvd flu vax is 1 of 15 pts who devel influenza & was hospitalized;					Y				U	11/15/1988	01/17/1989	63	NS	OTH	OTH	NS	NS	NS	~ ()~~~In patient	924090047	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~1108P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0046231	10/19/1992	MI				U	10/07/1992	pt recvd flu vax-was 1 of 15 who recvd vax & devel influenza & was hospitalized;					Y				U	11/15/1988	01/17/1989	63		OTH	OTH				~ ()~~~In patient	924090046	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~1108P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0046232	10/19/1992	MI				U	10/07/1992	pt recvd flu vax-pt was 1 of 15 who devel influenza & was hospitalized;					Y				U	11/15/1988	01/17/1989	63		OTH	OTH				~ ()~~~In patient	924090045	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~1108P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0046233	10/19/1992	MI				U	10/07/1992	pt recvd flu vax & was 1 of 15 who devel influenza & was hospitalized;					Y				U	11/15/1988	01/17/1989	63		OTH	OTH				~ ()~~~In patient	924090044	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~1108P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0046234	10/19/1992	MI				U	10/07/1992	pt recvd flu vax & was 1 of 15 pts who devel influenza & was hospitalized;					Y				U	11/15/1988	01/17/1989	63		OTH	OTH				~ ()~~~In patient	924090043	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~1108P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0046235	10/19/1992	MI				U	10/07/1992	pt recvd flu vax & was 1 of 15 pts who devel influenza & was hospitalized;					Y				U	11/15/1988	01/17/1989	63		OTH	OTH				~ ()~~~In patient	924090042	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~1108P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0046236	10/19/1992	MI				U	10/07/1992	pt recvd flu vax & was 1 of 15 pts who devel influenza & was hospitalized;					Y				U	11/15/1988	01/17/1989	63		OTH	OTH				~ ()~~~In patient	924090041	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~1108P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0046237	10/19/1992	MI				U	10/07/1992	pt recvd flu vax & was 1 of 15 pts who devel influenza & was hospitalized;					Y				U	11/15/1988	01/17/1989	63		OTH	OTH				~ ()~~~In patient	924090040	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~1108P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0046238	10/19/1992	MI				U	10/07/1992	pt recvd flu vax & was 1 of 15 pts who devel influenza & was hospitalized;					Y				U	11/15/1988	01/17/1989	63		OTH	OTH				~ ()~~~In patient	924090039	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~1108P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0046239	10/19/1992	MI				U	10/07/1992	Pt recvd flu vax  & was 1 of 15 pts who devel influenza & was hospitalized;					Y				U	11/15/1988	01/17/1989	63		OTH	OTH				~ ()~~~In patient	924090038	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~1108P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0046240	10/19/1992	MI				U	10/07/1992	pt recvd flu vax & 1 of 5 pts devel influenza & was hospitalized;					Y				U	11/15/1988	01/17/1989	63		OTH	OTH				~ ()~~~In patient	924090037	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~1108P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0046241	10/19/1992	MI				U	10/07/1992	pt recvd flu vax & was 1 of 15 pts who devel influenza & was hospitalized;					Y				U	11/15/1988	01/17/1989	63		OTH	OTH				~ ()~~~In patient	924090036	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~1108P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0046242	10/19/1992	MI				U	10/07/1992	pt recvd flu vax & was 1 of 15 pts who devel influenza & was hospitalized;					Y				U	11/15/1988	01/17/1989	63		OTH	OTH				~ ()~~~In patient	924090035	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~1108P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0046243	10/19/1992	MI				U	10/07/1992	Pt recvd flu vax & was 1 of 15 pts who devel influenza & was hospitalized;					Y				U	11/15/1988	01/17/1989	63		OTH	OTH				~ ()~~~In patient	924090034	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~1108P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0046244	10/19/1992	MI				U	10/07/1992	pt recvd flu vax & was 1 of 15 pts who devel influenza & was hospitalized;					Y				U	11/15/1988	01/17/1989	63		OTH	OTH				~ ()~~~In patient	924090033	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~1108P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0046245	10/19/1992	MI				U	10/07/1992	pt recvd flu vax & devel influenza leading to probable death; this pt & 1 other devel influenza following flu vax;			Y						U	11/15/1988	01/17/1989	63		OTH	OTH				~ ()~~~In patient	924090032	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~1108P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening	Influenza
0046246	10/19/1992	MI				U	10/07/1992	pt recvd flu vax & devel influenza leading to probable death; this pt & 1 other devel influenza following flu vax & both were reported about to expire, but no f/u info was obtained;			Y						U	11/15/1988	01/17/1989	63		OTH	OTH				~ ()~~~In patient	924090031	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~1108P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening	Influenza
0046247	10/19/1992	MI				U	10/07/1992	pt recvd flu vax & pt was 1 of 5 who devel influenza & died;	Y								N	11/15/1988	01/17/1989	63		OTH	OTH				~ ()~~~In patient	924090030	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~1108P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0046248	10/19/1992	MI				U	10/07/1992	pt recvd flu vax & was 1 of 5 who devel influenza & died;	Y								N	11/15/1988	01/17/1989	63		OTH	OTH				~ ()~~~In patient	924090029	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~1108P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0046249	10/19/1992	MI				U	10/07/1992	pt recvd flu vax & was 1 of 5 who devel influenza & died;	Y								N	11/15/1988	01/17/1989	63		OTH	OTH				~ ()~~~In patient	924090028	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~1108P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0046250	10/19/1992	MI				U	10/07/1992	pt recvd flu vax & was 1 of 5 pts who devel influenza & died;	Y								N	11/15/1988	01/17/1989	63		OTH	OTH				~ ()~~~In patient	924090027	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~1108P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0046251	10/19/1992	MI				U	10/07/1992	pt recvd flu vax & was 1 of 5 pts who devel influenza & died;	Y								N	11/15/1988	01/17/1989	63		OTH	OTH				~ ()~~~In patient	924090026	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~1108P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0046253	10/19/1992	LA	72.0	72		F	10/12/1992	redness over entire body, pruritus, PB 210/110, no audible wheezing; IV lactated ringers, DPH, Celeltone, Decadron, tranferred to ER;				Y	Y	2			Y	10/02/1992	10/02/1992	0		PVT	PVT				~ ()~~~In patient	CO4472	1						1	Hypertension; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~2F31098~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0046274	10/19/1992	LA	72.0	72		F	10/13/1992	MD called stating pt recvd flu shot approx 11AM 10OCT92 & @ approx 130PM exp dizziness, passed out, hit head & went to ER for suturing of laceration on head; while in ER, dizziness did not resolve;				Y	Y	3			U	10/10/1992	10/10/1992	0	Monitor showing V-tach scheduled echocardiogram;	OTH	UNK				~ ()~~~In patient	VA92107	1						1	Dizziness; Injury; Syncope; Ventricular tachycardia	FLU3~CONNAUGHT LABORATORIES~2F31148~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0046276	10/19/1992	TX	81.0	81		F	10/14/1992	seizures, grand mal w/in 12 hrs of vax; diffuse encephalopathy w/bilateral lower extremities & rt upper extremities paresis, aphasia;	Y		Y	Y	Y	6		Y	N	10/07/1992	10/08/1992	1	neg head CT x 2; neg LP; THeophylline level + digoxin levels non toxic;	OTH	PVT	Nasalide, Megace, Theophyllin, Digoxin, K Ce, Lasix, Coumadin, Iron, ALbuterol inhaler, Atrovent;	breast cancer w/metasitasis, CHF	organic brain synd, recurrent deep vein thrombosis & pulmonar-embolism;	~ ()~~~In patient		1						1	Aphasia; Encephalopathy; Grand mal convulsion; Paralysis; Encephalopathy; Grand mal convulsion; Paralysis; Stupor	FLU3~LEDERLE LABORATORIES~338971~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|FLU3~LEDERLE LABORATORIES~338971~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~2	USA	Results in Death	Influenza
0046298	10/19/1992	WI	52.0	52		F	10/13/1992	devel itchy rash 5 days p/receipt of vax; also devel sore arm which was achy & throbbing;									Y	10/01/1992	10/06/1992	5	NA	PVT	PVT		NONE	allergies to TCN, EES, Sulfa, Bactrim	NONE~ ()~~~In patient		1						1	Myalgia; Pruritus; Rash	FLUX~PFIZER\WYETH~4928215~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046312	10/20/1992	GA	27.0	27		F	09/28/1992	throwing up, fever, chills, sore legs;									Y	09/08/1992				PVT	PUB		NA	endometriosis, hypertension	~ ()~~~In patient		1						1	Chills; Myalgia; Pyrexia; Vomiting	FLUX~PFIZER\WYETH~4928133~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046313	10/20/1992	GA	47.0	47		F	09/28/1992	severe itching-lasted about 4 or 5 days;									Y	09/08/1992	09/09/1992	1	NA	PVT	PUB	Orudis, Norflex, Lasix, Prozac	NONE	Scoliosis, Lordosis, cervical & lumbar muscular fibrocitus/arthritis, tendonitus, brusitus, allergic to mos outdoor & indoors	NA~ ()~~~In patient		1						1	Pruritus	FLUX~PFIZER\WYETH~4928133~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046331	10/21/1992	IA	76.0	76		F	10/01/1992	pt recvd flu vax/pneumococcal vax & a wk later devel neurologic sxs including sensation deficit & partial paralysis; pt was adm to hosp to r/o GBS;					Y	12			U	09/16/1992	09/25/1992	9		PVT	OTH	BP medication	unk		~ ()~~~In patient	892276001E	1						1	Atrial fibrillation; Cerebrovascular accident; Coordination abnormal; Encephalitis; Guillain-Barre syndrome; Neuropathy peripheral; Paraesthesia; Respiratory disorder; Atrial fibrillation; CSF test abnormal; Neuropathy peripheral; Paraesthesia; Respiratory disorder; Speech disorder; Tachycardia; Urinary retention	FLUX~PFIZER\WYETH~4928224~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~7121530T~UNK~~~PNEUMO (PNEUMOVAX)~1|FLUX~PFIZER\WYETH~4928224~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~1530T~UNK~~~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0046333	10/21/1992	FL	68.0	68		F	10/05/1992	sx began @ 430PM, vax recvd 2OCT92 930AM pt felt dizzy, aching, fever, warm to touch, syncopal episode; called hosp ER & was advised to take Tylenol & drink fluids;									Y	10/02/1992	10/02/1992	0		PUB	PUB		NONE	breast cancer, NKA, mastectomy-takes Tamilifen	~ ()~~~In patient	FL92057	1						1	Dizziness; Myalgia; Pyrexia; Syncope	FLU3~PARKE-DAVIS~01872P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~08914~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0046334	10/21/1992	FL	69.0	69		M	10/05/1992	pt recvd vax 2OCT92 930AM & felt cold, aching, fever ?, w/perspiration by 2OCT92 @ 430 no sycope; APAP was taken & pt felt better by 3OCT92;									Y	10/02/1992	10/02/1992	0		PUB	UNK		NONE	prostatitis-takes doxycycline	~ ()~~~In patient	FL92058	1						1	Chills; Hyperhidrosis; Myalgia; Pyrexia	FLU3~PARKE-DAVIS~01872P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~08914~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0046344	10/22/1992	CT	65.0	65		F	10/08/1992	Pt recvd flu vax & 7 days later exp an exacerbation of COPD; arterial blood gas determination demonstrated a po2 of 52 & pco2 of 68; pt marked wheezing; pt adm to hosp;			Y		Y				U	09/27/1992	10/08/1992	11		OTH	OTH	Synthroid, Haldol & others;	NONE	pt has chronic obstructive pulmonary disease;	~ ()~~~In patient	892283002E	1						1	Asthma; Condition aggravated; Hypoxia; Respiratory acidosis	FLUX~PFIZER\WYETH~4928227~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0046362	10/22/1992	NY	42.0			M	10/15/1992	warm flushes, aches generalized, malaise, nausea, 1 day p/receiving flu vax;														PUB	UNK	NONE	NONE	allergic to PCN	NONE~ ()~~~In patient		1						1	Malaise; Myalgia; Nausea; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~2F31003~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046379	10/23/1992	TN	46.0	46		F	10/08/1992	chills, fever, aching all over;										10/07/1992	10/07/1992	0		PUB	PUB				~ ()~~~In patient	TN92118	1						1	Chills; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~2F31097~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0046380	10/23/1992	TN	31.0	31		M	10/09/1992	inject site red & warm 1-2 inches in diameter;										10/07/1992	10/08/1992	1		PUB	PUB				~ ()~~~In patient	TN92119	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~2F31097~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0046386	10/23/1992	TN	42.0	42		M	10/16/1992	ache, t99.3, nausea started last noc feels better this morning;										10/14/1992	10/15/1992	1		PUB	PUB				~ ()~~~In patient	TN92125	1						1	Myalgia; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~2F31097~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0046412	10/23/1992	WA	29.0	29		F	10/07/1992	tired, chills, myalgia x 2 days; t101, dizzy; cold sx;									Y	10/03/1992	10/03/1992	0	NONE	PVT	PVT	NONE		hashimoto's thyroiditis	NONE~ ()~~~In patient	WA92775	1						1	Asthenia; Chills; Dizziness; Myalgia; Pharyngitis; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~4928213~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046413	10/23/1992	WA	44.0	44		F	10/07/1992	arm hurt very bad, nausea, chills, 2x4 wheal; took DPH next day 99-100 fever, nausea;									Y	10/03/1992	10/03/1992	0	NONE	PVT	PVT	Clonidine patch for hot flashes	husband has cold	breast cancer last yr (chemotherapy until AUG92); allergic to PCn-rash;	NONE~ ()~~~In patient	WA92776	1						1	Chills; Nausea; Pain; Pyrexia; Urticaria	FLUX~PFIZER\WYETH~4928213~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046424	10/23/1992	TX	43.0	42		M	10/19/1992	sore arm, sore neck, ha, no fever, blister @ inject site seen by MD;									Y	10/16/1992	10/19/1992	3	NONE	PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Headache; Injection site reaction; Myalgia; Neck pain	FLU3~CONNAUGHT LABORATORIES~2F31112~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0046425	10/23/1992	WA	48.0	48		F	10/21/1992	feeling flushed, appears flushed c/o feeling light-headed; BP 118/78 denies chest tightness;									U	10/21/1992	10/21/1992	0		PUB	OTH	Minipress		MS-dx'd AUG92	~ ()~~~In patient		1						1	Dizziness; Vasodilatation	FLUX~PFIZER\WYETH~4928204~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046426	10/23/1992	WI	62.0	62		U		swollen lt deltoid 5 x 7;									Y	10/05/1992	10/05/1992	0		PVT	PVT	Ienex	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site oedema	FLUX~PFIZER\WYETH~4928215~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046496	10/26/1992	HI	82.0	82		F	07/10/1992	aching in rt arm began 2 mons p/vax recvd, & still aches @ noc, p/writing/baking; hx of arthritis, rx past 10 yrs Seldane this is not an arthritis-like pain;								Y	U	11/13/1991	01/13/1992	61	NONE	PUB	PUB	Dioxin, Baby ASA, Seldane, Maxide, Potassium, Premarin	NONE	arthritis, diverticulitis	NONE~ ()~~~In patient	HI9210	1						1	Myalgia	FLU3~PARKE-DAVIS~148P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~314914~UNK~~~PNEUMO (PNU-IMUNE)~1	USA	Disabling	Influenza
0046497	10/26/1992	HI	83.0	83		M	07/10/1992	aching in lt arm since vax recvd, difficulty using arm; still aches everyday cannot raise arms to reach for things up high; hx of brucitis in rt arm, arthritis & bad back (surgery 3 times);								Y	U	11/13/1991	11/13/1991	0	NONE	PUB	PUB	Feldene	NONE	brucitis rt arm, back (surgery x 3) injury, arthritis;	NONE~ ()~~~In patient	HI9209	1						1	Hypokinesia; Myalgia	FLU3~PARKE-DAVIS~148P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~314914~UNK~~~PNEUMO (PNU-IMUNE)~1	USA	Disabling	Influenza
0046498	10/26/1992	NH	39.0	39		M	10/19/1992	w/in 1 hr of flu shot being administered, devel difficulty breathing & began to wheeze;				Y					Y	10/14/1992	10/14/1992	0		PUB	PVT	NONE	NONE	hx arthritis, asthma, heart murmur	~ ()~~~In patient	NH92010	1						1	Asthma; Dyspnoea	FLU3~CONNAUGHT LABORATORIES~23F1101~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0046502	10/27/1992	MA	41.0	41		M	10/16/1992	swelling in arms, arm sore & under arm sore;									Y	10/14/1992	10/15/1992	1		PUB	PUB		NONE		~ ()~~~In patient	MA9213	1						1	Myalgia; Oedema	FLUX~PFIZER\WYETH~4928222~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046507	10/27/1992	KY	60.0	60		F	10/21/1992	redness & swelling @ inject site & below; suspect cellulitis;				Y					U	10/19/1992	10/19/1992	0	treating w/ATB;	PVT	PVT			NONE	~ ()~~~In patient		1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Oedema; Vasodilatation	FLU3~PARKE-DAVIS~00882P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~308904~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0046518	10/27/1992	MN	45.0	45		F	10/21/1992	pt c/o burning sensation of lip then lip became swollen @ 5PM 20OCT92-flu shot adm 20OCT92 930AM; states lip 3x nl; no other signs or sx; exam otherwise WNL:									U	10/20/1992	10/20/1992	0	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Face oedema; Pain	FLUX~PFIZER\WYETH~4928222~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046519	10/27/1992	PA	29.0	28		F	10/22/1992	c/o hot flash to head & dullness to lt occipital area; BP 124/70, HR 72 regular, resp 20 even labored, neg visual disturbance; neg swelling, no redness @ site;									Y	10/22/1992	10/22/1992	0		PUB	PVT				~ ()~~~In patient		1						1	Pain; Vasodilatation	FLUX~PFIZER\WYETH~4928130~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046525	10/27/1992	WV	51.0	51		F	10/20/1992	pt recvd flu vax & exp raised area around inject site 1st 24 hrs p/inject & c/o itching, generalized rash w/in raised area @ inject site;										10/14/1992	10/14/1992	0		OTH	OTH	UNK	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046526	10/28/1992	CA	56.0	56		M	10/16/1992	pt recvd flu vax & devel sudden onset of hypotension, hypoglycemia & chills; pt suffered a cardiac arrest & was hospitalized & died;	Y	10/16/1992	Y	Y	Y	2			N	10/12/1992	10/14/1992	2		PVT	OTH		following Hemodialysis	pt had chronic renal failure	~ ()~~~In patient	892293001E	1						1	Apnoea; Cardiomegaly; Confusional state; Hypotension; Leukocytosis; Myocardial infarction; Pulmonary oedema; Vascular occlusion	FLUX~PFIZER\WYETH~4928234~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0046527	10/28/1992	CA	60.0	60		U	10/16/1992	pt recvd flu vax & following dialysis pt devel hypotension & loss of consciousness; 1 liter IV saline was administered & pt was hospitalized;			Y	Y	Y	13	Y		U	10/12/1992	10/14/1992	2		PVT	OTH		following hemodialysis	pt has chronic renal failure	~ ()~~~In patient	892293002E	1						1	Dyspnoea; Haemorrhage; Hypotension; Paralysis; Pleural effusion; Pneumonia; Stupor; Thinking abnormal	FLUX~PFIZER\WYETH~4928234~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0046528	10/28/1992	MI	94.0			F	10/13/1992	Pt recvd flu vax the next evening devel a rash & some blisters on breasts & back; dx w/herpes zoster; tx Zovirax & DPH; also exp inc BP & hallucinations; adm to hosp 12OCT92;	Y				Y				U	10/06/1992	10/07/1992	1		OTH	OTH				~ ()~~~In patient	892289001E	1						1	Atrial fibrillation; Dermatitis bullous; Hallucination; Herpes zoster; Hypertension; Pyrexia; Rash	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0046552	10/29/1992	WV	69.0	69		M	10/15/1992	rash devel over body on 8OCT92, same day as vax treated on 11OCT92 by pvt MD; rash lasted approx 10 days;				Y					Y	10/08/1992	10/08/1992	0		PUB	PUB		NONE	NONE	~ ()~~~In patient	WV9237	1						1	Rash	FLU3~PARKE-DAVIS~01872P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0046553	10/29/1992	WV	68.0	68		F	10/15/1992	devel red itching blotches on chin around nose forehead & above eyes; 10OCT92 in the AM p/took flu vax about 1130AM-9OCT92-says still has itching on face;									N	10/09/1992	10/10/1992	1		PUB	PUB	NONE	NONE	allergic to sun exposure	~ ()~~~In patient	WV9238	1						1	Pruritus; Rash maculo-papular	FLU3~PARKE-DAVIS~01872P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0046562	10/29/1992	NC	65.0	65		M	10/26/1992	h/a in back of head; feels like has the flu, aches all over; no feveror URI;										10/07/1992	10/24/1992	17		PUB	PUB		denies	hx of hypertension & respiratory problems;	~ ()~~~In patient	NC93031	1						1	Headache; Influenza; Myalgia; Headache; Influenza	FLU3~CONNAUGHT LABORATORIES~2F31150~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~2F31150~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0046563	10/29/1992	MA	90.0	90		F	10/26/1992	upper resp infect, low grade fever, cough, stuffy head; occurred 1 day p/flu vax; pt came to office 5 days later; tx w/Robitussin, Vit C 7 keflex;									Y	10/14/1992	10/15/1992	1	NONE	PVT	PVT	Coumadin, Lasix, Procardia, OXazepam, Nitro Dur;	ASCVD	sulfa, PCN, trilisate	~ ()~~~In patient		1						1	Cough; Pharyngitis; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~4928207~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046564	10/29/1992	MO	42.0	42		F	10/26/1992	15OCT 2.5-3.0 cm round area of erythema w/itching; 26OCT 1.5 cm area red & hard no itching;									Y	10/14/1992	10/15/1992	1		PVT	PVT	Premarin, Deconaminea SR	NONE	Pollen, bactrim, hypoglycemia	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Pruritus	FLU3~CONNAUGHT LABORATORIES~2F31117~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0046569	10/30/1992	MO	72.0	72		F	10/20/1992	vomiting, diarrhea, & eyes burning & red; was 1st flu shot; hard time breathing p/630PM; did not go to MD; taking APAP & resting;									Y	10/19/1992	10/19/1992	0		PUB	PUB	NONE	NONE	asthma	NONE~ ()~~~In patient	MO92068	1						1	Conjunctivitis; Diarrhoea; Dyspnoea; Vomiting	FLU3~PARKE-DAVIS~01772P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0046571	10/30/1992	IL	31.0	31		F	10/13/1992	29SEP92 recvd flu vax; 1OCT92 c/o pain in chest & arms w/PC to pvt MD; 3OCT92 ER visit-ER MD states was reaction to flu shot;				Y					Y	09/29/1992	10/01/1992	2		OTH	PVT		NONE		~ ()~~~In patient		1						1	Chest pain; Pain	FLU3~CONNAUGHT LABORATORIES~2F31143~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0046276	11/02/1992	TX	81.0	81		F	10/14/1992	14 hrs p/flu-imune 7OCT92, pt had grand mal sz; 14OCT had diffuse encephalopathy-no longer vervally responsive; bilateral lower extremity & rt upper extremity paresis; CT of brain performed 9OCT & 13OCT neg for brain METS;	Y				Y	8			N	10/07/1992	10/08/1992	1	CT Scan-Brain 9OCT & 13OCT-neg; neg LP; no evidence of stroke/CVA; Theophylline & digoxin levels were non-toxic; family members fefused all addt diagnostic test pas 2nd ct (EG.EEG);	PVT	PVT	Nasalide, Megace, Theophylline, Digoxin, KCL, Lasix, ETC;	breast cancer w/metastases; CHF	organic brain synd, recurrent deep bein thrombosis & pulmonary embolism;	NA~ ()~~~In patient	920349501	1						2	Aphasia; Encephalopathy; Grand mal convulsion; Paralysis; Encephalopathy; Grand mal convulsion; Paralysis; Stupor	FLU3~LEDERLE LABORATORIES~338971~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|FLU3~LEDERLE LABORATORIES~338971~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~2	USA	Results in Death	Influenza
0046613	11/02/1992	PA	71.0	71		F	09/25/1992	pt became dizzy & had diarrhea & vomiting, BP was inc 200; pt went to the hospital & they kept for 4 hrs;				Y					Y	09/16/1992	09/21/1992	5		OTH	PVT	Lopressor, Nitrobid, Tedrol	NONE	NONE	~ ()~~~In patient	PA92284	1						1	Diarrhoea; Dizziness; Hypertension; Vomiting	FLUX~PFIZER\WYETH~4928116~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0046631	11/02/1992	CA	75.0	75		F	10/27/1992	nausea & vomiting & diaphoresis;				Y	Y	1			Y	10/27/1992	10/27/1992	0	NONE relevant-CBC nl;	PVT	PUB	Lanoxin, vasotec, premarin, urecholine, prilosec, reglan, prozac	chronically ill	lt thorasic post herpetic neuralgia, hypertension, hiatal hernia, peptic ulcer disease, esophagial congestion;	NONE~ ()~~~In patient		1						1	Hyperhidrosis; Nausea; Vomiting; Hyperhidrosis; Nausea; Vomiting	FLUX~PFIZER\WYETH~4928234~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928234~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0046636	11/02/1992	TX	37.0	37		F	10/29/1992	fever to 103 on 28OCT92 w/myalgias, sl h/a; local erythema around inject noted on noc of inject, erythematos tonsils-cervical adenopathy, t102.1, tachycardia rate 120;				Y					U	10/27/1992	10/28/1992	1	CBC 8,400WBC'S 70% granulocytes, 30% lympho; strep screen neg;	OTH	PVT	Birth control (Demulen)	NONE	NONE	NONE~ ()~~~In patient		1						1	Headache; Injection site hypersensitivity; Lymphadenopathy; Myalgia; Pharyngitis; Pyrexia; Tachycardia	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0046637	11/02/1992	CA	72.0	72		F	10/28/1992	swelling around face, rash on neck & difficulty swallowing;				Y					Y	10/27/1992	10/27/1992	0	No lab work done;	PUB	PUB	Ogen	NONE	Pneumovax	pt exp dyspnea, tightness in chest @ 68 y/o w/pneumovax #1 dose;~ ()~~~In patient	CA92130	1						1	Dysphagia; Face oedema; Rash	FLUX~PFIZER\WYETH~492234~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0046642	11/02/1992	NC	40.0	40		F	10/30/1992	nasal congestion & drainage; itching @ eyes & throat; full feeling in larynx & trachea; chest discomfort; sx responded to Epi & DPH;				Y					Y	10/27/1992	10/27/1992	0	NONE	OTH	PVT	Orudis	NONE	allergic to erythromycin	~ ()~~~In patient		1						1	Chest pain; Laryngospasm; Pruritus; Rhinitis	FLU3~PARKE-DAVIS~001929~6~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0046648	11/02/1992	KS	47.0	47		F	10/28/1992	pt given vax @ 230PM-by 6PM devel a hacking, cough, eyes swollen, hives, airway closing, aching all over took DPH; 28OCT92 eyes still swollen; woke up in the noc screaming;									Y	10/26/1992	10/26/1992	0	NONE	PUB	PUB	NONE		NONE	NONE~ ()~~~In patient	KS92068	1						1	Cough; Crying; Face oedema; Laryngospasm; Myalgia; Urticaria	FLU3~PARKE-DAVIS~00682P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0046650	11/02/1992	IA	11.0	11		F	10/23/1992	syncope p/1st & 2nd dose of Engerix-Hep B vax;									Y	10/22/1992	10/22/1992	0	NONE	OTH	OTH	NONE	NONE	NONE	pt exp syncope 29JUL92 @ Engerix-B #1 dose;~ ()~~~In patient		1						1	Syncope	FLUX~PFIZER\WYETH~4928226~3~~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~SMITHKLINE BEECHAM~849A4~2~IM~RL~HEP B (ENGERIX-B)~1	USA		Influenza
0046652	11/02/1992	PA	49.0	48		M	10/23/1992	pt reported via phone on 21OCT92 that pt devel rash, hives & nausea, day after receiving flu vax;									Y	10/05/1992	10/06/1992	1	NONE	PVT	UNK	Dilantin, Phenobarb	NONE	seizure disorder cardiac valvular	neg~ ()~~~In patient		1						1	Nausea; Rash; Urticaria; Nausea; Rash; Urticaria	FLU3~LEDERLE LABORATORIES~337909~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|FLU3~LEDERLE LABORATORIES~337909~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~2	USA		Influenza
0046665	11/02/1992	NC	41.0	40		F	10/28/1992	rash across chest area et lt arm c/o thrist, denies h/a, resp & GI sx;									Y	10/27/1992	10/28/1992	1	NA	PUB	PUB	NONE	NONE	pt reports (req reaction) to ofc but not dx;	~ ()~~~In patient	NC92074	1						1	Rash; Thirst; Rash	FLU3~CONNAUGHT LABORATORIES~2731150~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0046666	11/02/1992	NC	64.0	64		F	10/28/1992	swollen, redness, weak, soreness & pain on movement to lt arm x 1 wk;									Y	10/22/1992	10/22/1992	0		PUB	PUB	BP meds, arthritis meds	NONE	hypertension, arthritis, allergic to clinoril	~ ()~~~In patient	NC92075	1						1	Myalgia; Oedema; Pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046746	11/02/1992	PA	27.0	27		F	09/03/1992	following vax w/flu pt devel a local reaction, a circular red welt the size of a one half dollar which eventually faded;									Y	10/31/1991	10/31/1991	0		OTH	OTH	UNK			~ ()~~~In patient	892279008K	1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~1F21219~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0046747	11/02/1992	IA	58.0	58		F	09/30/1992	pt recvd flu vax & devel redness & warmth @ inject site for 3 days; pt then exp itching for 3 days;									Y	10/29/1991				OTH	OTH			pt is allergic to Procardia, Sulfa & Cefizox	~ ()~~~In patient	892283001E	1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046770	11/02/1992	WY	69.0			F	09/25/1992	pt who has a resp disorder recvd flu vax & serum theophylline level became elevated & exp a sz for which was hospitalized;					Y				U					UNK	UNK	Quinidex, Premarin, Proventil, Azmacort inhaler, Theo-dur		Resp disorder	~ ()~~~In patient	892279009K	1						1	Convulsion; Drug interaction; Laboratory test abnormal	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0046771	11/02/1992	GA	45.0	45		F	09/18/1992	pt recvd flu vax 17SEP92 & devel hives, resp distress, swelling of the neck, wheezing;					Y	3			U	09/17/1992	09/17/1992	0		PVT	PVT	Theo-dur sprinkle, Ventolin inhaler, Xanax;	Asthma (only ankle edema)	pt has asthma; pt has no known allergies;	~ ()~~~In patient	892279010K	1						1	Atrioventricular block; Chest pain; Condition aggravated; Dyspnoea; Face oedema; Hypotension; Tachycardia; Urticaria	FLUX~PFIZER\WYETH~4928146~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0046772	11/02/1992	DE	52.0			F	09/17/1992	pt recvd flu vax & devel redness, pain & swelling @ the site of inject;									U					PVT	PVT				~ ()~~~In patient	892279001E	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4928221~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046773	11/02/1992	CT	55.0	55		M	09/28/1992	pt recvd flu vax & 8 to 9 days later devel a viral synd assoc w/lt sided chest pain; evaluation in ER was unrevealing; pt cont to have cough & sx of bronchitis;				Y					U	09/14/1992	09/25/1992	11	EKG-nl; CXR-nl;	PVT	PVT	Micronase, tagamet	diabetes mellitus	pt has diabetes; has no known allergies to vax components;	~ ()~~~In patient	892279001K	1						1	Bronchitis; Chest pain; Cough; Infection	FLUX~PFIZER\WYETH~4928227~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0046774	11/02/1992	DE	45.0	45		U	09/17/1992	pt recvd flu vax & devel redness, pain & swelling @ site of inject;									U	10/24/1992				PVT	PVT				~ ()~~~In patient	892279002E	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4928221~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046775	11/02/1992	NY	58.0			U	09/22/1992	pt recvd flu vax & exp redness & burning @ inject site; pt also devel rt ax lymphadenopathy w/in 24 hrs of the inject;									U					UNK	UNK				~ ()~~~In patient	892279002K	1						1	Injection site hypersensitivity; Lymphadenopathy	FLUX~PFIZER\WYETH~4928130~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046776	11/02/1992	DE	50.0			F	09/17/1992	pt recvd flu vax & devel redness, pain & swelling @ the site of inject;									U					PVT	PVT				~ ()~~~In patient	892279003E	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4928221~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046777	11/02/1992	NY				U	09/22/1992	Pt recvd flu vax & devel erythema @ the site of inject which persisted for 24 to 48 hrs;									U					UNK	UNK				~ ()~~~In patient	892279003K	1						1	Injection site hypersensitivity	FLUX~PFIZER\WYETH~4928130~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046778	11/02/1992	DE				U	09/17/1992	pt recvd flu vax & devel redness, pain & swelling @ the site of inject;									U					PVT	PVT				~ ()~~~In patient	892279004E	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046779	11/02/1992	NY	32.0			U	09/22/1992	pt recvd flu vax & devel erythema @ the site of inject which persisted for 24 to 48 hrs;									U					UNK	UNK				~ ()~~~In patient	892279004K	1						1	Injection site pain	FLUX~PFIZER\WYETH~4928130~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046780	11/02/1992	DE				U	09/17/1992	pt recvd flu vax & devel redness, pain & swelling @ site of inject;									U					PVT	PVT				~ ()~~~In patient	892279005E	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046781	11/02/1992	NY				U	09/22/1992	pt recvd flu vax & devel erythema @ site of inject which persisted for 24 to 48 hrs;									U					UNK	UNK				~ ()~~~In patient	892279005K	1						1	Injection site hypersensitivity	FLUX~PFIZER\WYETH~4928130~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046782	11/02/1992	DE				U	09/17/1992	pt recvd flu vax & devel redness, pain & swelling @ the site of inject;									U					PVT	PVT				~ ()~~~In patient	892279006E	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046783	11/02/1992	AL	63.0	63		F	09/29/1992	pt recvd flu vax & devel redness that went down to the elbow of the arm where inject was given;									U	09/22/1992	09/23/1992	1		PVT	PVT	heart med			~ ()~~~In patient	892279006K	1						1	Injection site hypersensitivity; Pruritus; Pyrexia	FLUX~PFIZER\WYETH~4928228~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046784	11/02/1992	DE				U	09/17/1992	pt recvd flu vax & devel redness, pain & swelling @ the site of inject;									U					PVT	PVT				~ ()~~~In patient	892279007E	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046785	11/02/1992	MN				M	09/25/1992	pt recvd flu vax & devel 10cm area of inflammation & induration;									U	09/01/1992	09/01/1992	0		PVT	PVT				~ ()~~~In patient	892279007K	1						1	Injection site inflammation; Injection site mass	FLU3~CONNAUGHT LABORATORIES~~UNK~SC A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0046786	11/02/1992	DE				U	09/17/1992	pt recvd flu vax & devel redness, pain & swelling @ site of inject;									U					PVT	PVT				~ ()~~~In patient	892279008E	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046680	11/03/1992	NH	83.0	83		M	10/22/1992	5 days p/flu shot pt devel large hives & itching all over; t102; pt seen @ clinic by MD, crackles lower lobe, CXR done, dx pneumonia; Erythromycin & DPH for hives;				Y					Y	10/06/1992	10/11/1992	5	CXR	PUB	PUB	Cardizem, Isordil	NONE	NONE	NONE~ ()~~~In patient	NH92011	1						1	Pneumonia; Pruritus; Pyrexia; Urticaria	FLUX~PFIZER\WYETH~4928227~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0046681	11/03/1992	NH	81.0	81		F	10/26/1992	on 17OCT pt contacted MD re: red & itchy skin, blotches on torso & legs; pt seen by MD on 18OCT & 19OCT told to d/c Naprosyn (as poss cause) & given DPH; med helped & blotches became less red & itchy; pt seen by RN 26OCT92-no itching, blotc				Y					Y	10/06/1992	10/17/1992	11		PUB	PUB	Calan, Naprosyn	NONE	NONE	~ ()~~~In patient	NH92012	1						1	Pruritus; Rash maculo-papular; Vasodilatation	FLUX~PFIZER\WYETH~4928227~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0046684	11/03/1992	MN	54.0	54		F	10/27/1992	22OCT92 830PM chills, frequent urination, fever, vomiting 2x, myalgias, fatigue, anorexia;									Y	10/22/1992	10/22/1992	0	NONE	PUB	PUB	taking iron & calcium supplements	NONE	NONE	NONE~ ()~~~In patient	MN92053	1						1	Anorexia; Asthenia; Chills; Myalgia; Polyuria; Pyrexia; Vomiting	FLUX~PFIZER\WYETH~4928226~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~334958~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0046687	11/03/1992	DC	75.0	75		F	10/30/1992	quarter size area, lump near site of inject- no pain; but purple around where needle went in & above it-now resolving; discoloration @ site of inject;									Y	10/22/1992	10/30/1992	8	NA	OTH	PUB	NONE	NONE	Iodine dye, aspirin, ragweed, pollen, & grass	NONE~ ()~~~In patient		1						1	Injection site mass; Injection site pain; Skin discolouration	FLU3~LEDERLE LABORATORIES~337935~1~~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0046690	11/03/1992	ND	44.0	44		F	10/29/1992	5 days p/the vax pt devel h/a, nausea, low grade fever, fatigue, hyperactive bowel sounds;									Y	10/22/1992	10/27/1992	5	NONE	PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Gastrointestinal disorder; Headache; Nausea; Pyrexia	FLUX~PFIZER\WYETH~4929131~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046691	11/03/1992	OH	78.0	78		F	10/26/1992	h/a, nausea, diarrhea, redness & swelling @ inject site; sx began next day & lasted 24 hrs; arm swelling lasted 1 wk; APAP only treatment;									Y	10/20/1992	10/21/1992	1	NONE	PVT	PVT	Synthroid, anticoagulant	NONE	NKA	~ ()~~~In patient		1						1	Diarrhoea; Headache; Injection site hypersensitivity; Injection site oedema; Nausea	FLUX~PFIZER\WYETH~4928226~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046692	11/04/1992	WI	54.0	54		M	10/22/1992	pt recvd flu vax 3OCT92 & on 17OCT92 reported progressive numbness & weakness in lower extremities; adm to hosp 19OCT92 w/ascending paralysis, thought to be GBS;			Y		Y				U	10/03/1992	10/16/1992	13		PUB	OTH	numerous-unspecified		pt has polycystic kidney disease & required hemodialysis;	~ ()~~~In patient	892297001E	1						1	Asthenia; Guillain-Barre syndrome; Paraesthesia; Paralysis	FLUX~PFIZER\WYETH~4928136~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0046695	11/04/1992	MO	83.0	83		F	10/27/1992	27OCT 10AM dizzy, vomiting, has not seen MD @ this time;									U	10/24/1992	10/27/1992	3		PVT	OTH	Cadizem, Zantac, potassium	NONE	sl parkinsons disease	~ ()~~~In patient	MO92069	1						1	Dizziness; Vomiting	FLUX~PFIZER\WYETH~4928207~6~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046696	11/04/1992	MO	3.0	3		M	10/28/1992	mom states 4 days p/flu shot pt more fussy than usual- fever; severe asthma attack which required mom to give treatment of Intal & ventolin; not seen by MD or in ER; 27OCT92 t102 oral, nasal d/c green, diff breathing thru nose, lethargic;										10/19/1992	10/23/1992	4	NONE	PUB	PUB	Intal & ventolin in nebulizer	chronic asthma	asthma-no other allergies etc per mom	~ ()~~~In patient	MO92070	1						1	Agitation; Anorexia; Condition aggravated; Insomnia; Pyrexia; Rhinitis; Somnolence	FLU3~PARKE-DAVIS~01772P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0046704	11/05/1992	PA	64.0			F	10/08/1992	death is reported in a pt who recvd 1 dose of flu vax 2OCT; pt died in sleep on 3OCT; coroner stated that there was no evidence of swelling or anaphylaxis & believed that pt died in sleep of natural causes or a coronary;	Y								N	10/02/1992	10/03/1992	1	n/s	PUB	OTH	n/s	n/s	n/s	~ ()~~~In patient	924092014	1						1	Cardiac arrest; Unevaluable event	FLU3~PARKE-DAVIS~01272P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~01272P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Results in Death	Influenza
0046705	11/05/1992	PA	64.0			F	10/08/1992	death is reported in a pt who recvd flu vax on 2OCT; pt died on 5OCT92 w/no final cause of death given; an autopsy was performed; coroner believed that pt died of CVA; pt had undergone facial sinus surgery 2 wks prior to death;	Y	10/05/1992							N	10/02/1992	10/05/1992	3	n/s	PUB	OTH	n/s	n/s	surgery on facial sinus; brain stem infarct	~ ()~~~In patient	924092015	1						1	Cerebrovascular accident	FLU3~PARKE-DAVIS~01272P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0046710	11/05/1992	PA	66.0	66		F	10/26/1992	throat sore & tight, bronchial spasm flushed cheeks; rx ventilator & Decadron				Y					Y	10/23/1992	10/23/1992	0	NONE	PUB	UNK		NONE	allergic to dust-trees-peppers-grass-some ATB-pork-perfume	~ ()~~~In patient	PA92300	1						1	Asthma; Laryngospasm; Pharyngitis; Vasodilatation	FLU3~PARKE-DAVIS~00882P~2~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0046716	11/05/1992	PA	60.0			M		became acutely ill w/fever of unk origin; fever was 104; adm to hosp ICU;					Y					10/01/1992	10/01/1992	0		UNK	UNK	pt was heart transplant candidate @ time of vax			~ ()~~~In patient		1						1	Pyrexia	FLUX~PFIZER\WYETH~4928130~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0046718	11/05/1992	MN				F	11/02/1992	blister 4mm @ puncture site w/surrounding erythemia;				Y					Y	10/29/1992	10/31/1992	2	NONE	PVT	UNK		N/A	ankylosing spondylitis, ulcer disease	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site reaction	FLU3~CONNAUGHT LABORATORIES~2F31098~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0101V~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0046721	11/05/1992	MN	49.0	49		F	10/30/1992	rash around neck on 18OCT92; arms on the 20OCT92; abdomen 21OCT92; non pruritic; seen by MD on 20OCT92; dx poss vax related exanthem;				Y					Y	10/16/1992	10/18/1992	2		PUB	PVT	NONE	NONE	NONE	pt exp rxn @ 4 or 5 w/smallpox~ ()~~~In patient		1						1	Rash	FLUX~PFIZER\WYETH~4928136~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0046725	11/05/1992	CO	22.0	22		M	10/30/1992	approx 45 mins p/inject of vax in lt deltoid pt had episode of diaphoresis, mild lightheadedness, & frontal h/a; sx lasted 20-30 mins;				Y					Y	10/30/1992	10/30/1992	0	NONE	MIL	MIL	NONE	NONE	NONE	~ ()~~~In patient		1						1	Dizziness; Headache; Hyperhidrosis	FLUX~PFIZER\WYETH~4928239~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0046726	11/05/1992	CA	76.0	76		F	10/30/1992	bell's palsy-90% complete paralysis 2 wks p/flu shot; no other neuro sx;				Y					N	10/12/1992	10/17/1992	5	NONE	OTH	OTH	Vasotec	NONE	elevated BP	~ ()~~~In patient		1						1	Facial palsy	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0046728	11/05/1992	AZ	54.0	54		F	11/02/1992	c/o tenderness-edema-warmth @ inject site (rt deltoid) noted erythema of the site;									Y	10/28/1992	10/30/1992	2	NONE	PUB	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~2F31144~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0046730	11/05/1992	NC				F	11/02/1992	pt recvd vax 22OCT92 c/o redness, pain & swelling @ site & surrounding area next day; tx for 3-4 days w/warm compresses to MD 30OCT92; recvd inject & po meds; area still red & warm to touch today;									Y	10/22/1992	10/23/1992	1	NONE	PUB	PVT	Niacin, BP med;	NONE	elevated BP	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation; Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~2F31150~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~2F31150~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0046736	11/06/1992	HI	61.0	61		F	10/21/1992	pt reports severe reaction to site, pain & swelling, swollen lymph nodes; whole arm swollen evening of the shot, swelling has subsided today;									Y	10/20/1992	10/20/1992	0		PUB	PUB	Pneumo vax lot# 322926 given 28JAN92; flu vax lot# 2F3456 given SEP92;	NONE		~ ()~~~In patient	HI9213	1						1	Injection site oedema; Injection site pain; Lymphadenopathy; Oedema	FLU3~CONNAUGHT LABORATORIES~2F31156~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~322926~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0046737	11/06/1992	NY	13.0	13		M	11/03/1992	48 hrs p/vax, devel urticaria, pain & swelling of arms, hands, ankles & feet lasting 4 days;									Y	10/26/1992	10/28/1992	2	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Oedema peripheral; Pain; Urticaria	FLU3~CONNAUGHT LABORATORIES~2F31149~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0046787	11/09/1992	PA	74.0			F	10/08/1992	Death & myocardial infarction are reported in pt who recvd flu vax on 2OCT92; 3OCT92 was not feeling well & went to ER; had MI (full EKG changes); pt had a classical heart attack & died;	Y								N	10/02/1992	10/03/1992	1	n/s	PUB	OTH	n/s	n/s	h/o heart disease	~ ()~~~In patient	924092016	1						1	Cardiovascular disorder; Electrocardiogram abnormal; Malaise; Myocardial infarction	FLU3~PARKE-DAVIS~01272P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0046816	11/09/1992	TN	72.0	71		M	10/14/1992	pt's wife reported pt w/fever & chills, dry cough 2 days p/receiving flu vax; to MD on 12OCT92 4 days p/vax; told reaction to flu vax & had flu; was given Suprax & provental;				Y						10/08/1992	10/10/1992	2		PUB	PUB	Persantine, ASA, Mevacor, Cardizem, Suprax, Provental		PCN, heart bypass 1990, Carotidx2 JUN91	~ ()~~~In patient	TN92127	1						1	Chills; Cough; Drug ineffective; Infection; Influenza; Pyrexia	FLUX~PFIZER\WYETH~4928235~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0046818	11/09/1992	TN	67.0	67		F	10/23/1992	has knot approx 1 in diameter that is feverish;										10/21/1992	10/23/1992	2		PUB	PUB				~ ()~~~In patient	TN92129	1						1	Skin nodule; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~2F31097~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0046819	11/09/1992	TN	56.0	56		F	10/26/1992	lost voice, weak, tired, sick, unable to sleep; will go to MD today;										10/23/1992	10/26/1992	3		PUB	PUB				~ ()~~~In patient	TN92130	1						1	Asthenia; Dysphonia; Insomnia; Malaise	FLUX~PFIZER\WYETH~4928233~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046821	11/09/1992	TN	47.0	47		F	10/27/1992	10OCT sore throat; 11OCT could not talk, completely lost voice; felt bad like real bad cold; cough for several days;									Y	10/06/1992	10/10/1992	4		PUB	PUB				~ ()~~~In patient	TN92132	1						1	Cough; Dysphonia; Malaise; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~2F31097~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0046822	11/09/1992	TN	24.0	23		F	10/28/1992	vax was given @ pts work site; pt works in a sewing factory; told supervisor felt bad began crying & shaking, broke out in rash, face & neck began itching; no SOB or other life threating sx; sent to ER; 27OCT92 pt ok still had rash;				Y					Y	10/22/1992	10/22/1992	0	ER MD stated was allergic to flu vax never have another; pt missed 2 1/2 days of work;	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	TN92133	1						1	Agitation; Hypersensitivity; Malaise; Pruritus; Rash; Tremor	FLUX~PFIZER\WYETH~4928235~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0046824	11/09/1992	TN	76.0	76		F	11/04/1992	aching, flu sx, body sore, no appetite;										10/27/1992	11/02/1992	6		PUB	PUB				~ ()~~~In patient	TN92135	1						1	Anorexia; Influenza; Myalgia	FLU3~CONNAUGHT LABORATORIES~2F31097~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0046834	11/09/1992	IL	56.0	56		M	11/03/1992	Respiratory arrest; adm to ICU-placed on ventilator;					Y				U	10/30/1992	10/31/1992	1	EKG, CXR, CBC w/diff, Chem Profile;	PVT	PVT		NONE	COPD, pulmonary fibrosis	~ ()~~~In patient		1						1	Apnoea	FLU3~CONNAUGHT LABORATORIES~2F31132~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~302907~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0046843	11/09/1992	CA	68.0	68		F	11/02/1992	Pt called clinic p/got flu vax 27OCT92 & 29OCT92 devel body ache, temp, sore throat, stuffy nose; treated as a cold;									U	10/27/1992	10/29/1992	2		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	CA92129	1						1	Myalgia; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4928219~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046848	11/09/1992	NH	39.0	39		F	10/27/1992	tired, run-down, nauseous:-unable to keep up @ work;									Y	10/23/1992	10/27/1992	4		OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Asthenia; Nausea	FLUX~PFIZER\WYETH~4928115~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047074	11/10/1992	MO	59.0	59		F	10/30/1992	hives on abdomen, hips, legs, arms pruritus; no fever noted, soaked in tub & used rubbing alcohol; unable to get to MD; no transportation; onset 22OCT92 p/lunch 23OCT92AM all hives gone;									Y	10/16/1992	10/22/1992	6	NONE	PUB	PUB	NONE	NONE	PCN	~ ()~~~In patient	MO92072	1						1	Pruritus; Urticaria	FLU3~PARKE-DAVIS~01772P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0047076	11/10/1992	NV	72.0	72		F	10/27/1992	21OCT92 h/a & nausea; 22OCT92 feels like has flu, t102, body aches, stomach pains; 23OCT92 lt arm swollen & around under arm-red area; 26OCT92 lt arm red & swollen from elbow to shoulder place on Cephalexin by MD;				Y					Y	10/21/1992	10/21/1992	0		PUB	PUB	Imipramine, Cardizem	NONE	nervous breakdown 1985	~ ()~~~In patient	NV92019	1						1	Abdominal pain; Headache; Influenza; Injection site hypersensitivity; Injection site oedema; Myalgia; Nausea; Pyrexia	FLUX~PFIZER\WYETH~4928214~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~322926~UNK~~LA~PNEUMO (PNU-IMUNE)~1|TTOX~CONNAUGHT LABORATORIES~1K31145~UNK~~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047082	11/10/1992	WI	54.0			M		pt devel numbness & weakness in lower extremities on 17OCT92; ascending paralysis contained, pt adm to ICU; GBS;					Y					10/03/1992	10/17/1992	14		UNK	UNK	Nifedipine, Calcitriol, Metoprolol, Phoslo, Alloporinol		polycystic kidney disease, has been on hemodialysis x 6 months;	~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome; Paraesthesia; Paralysis; Paralysis flaccid	FLUX~PFIZER\WYETH~4928136~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0047086	11/10/1992	CO	21.0	20		M	11/02/1992	cramping & nausea devel w/in 10 mins of inject; discomfort cont x 5 hrs w/onset of vomiting x 1; mild sore throat devel in this time also; diffuse myalgias; also devel w/in 1 hr of inject;				Y					U	11/02/1992	11/02/1992	0	NONE	MIL	MIL	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Myalgia; Nausea; Pain; Pharyngitis; Vomiting	FLUX~PFIZER\WYETH~4928239~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047094	11/10/1992		32.0			F		swelling of tongue & lt cheek;				Y						10/23/1992				UNK	UNK	NA		NA	~ ()~~~In patient		1						1	Face oedema; Tongue oedema	FLUX~PFIZER\WYETH~4928246~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047103	11/10/1992	MI	34.0	34		M	11/06/1992	elevated temp; chills, achiness, nausea;									Y	09/30/1992	09/30/1992	0		PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Chills; Myalgia; Nausea; Pyrexia	FLU3~PARKE-DAVIS~01772P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0047104	11/10/1992	FL	31.0	31		F	11/04/1992	erythema 2-3cm & tenderness 4-5cm over lt deltoid 36 hrs p/vax; low grade temp, myalgia 36 hrs p/vax;										11/02/1992	11/04/1992	2	NONE	PVT	UNK	Uniphyl, Seldane, Proventil, Azultidine;	NONE	allergic to nuts, peanuts; h/o anaphylasix reaction to peanuts, asthma;	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~2F31171~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0100V~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0047107	11/12/1992	TX	72.0			F	11/05/1992	accidental overdose is reported in a pt receiving fluogen; pt has hx of alzheimer's disease; this is 1 of 30 cases reported from this site; no adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	alzheimer's disease	UNK	~ ()~~~In patient	924092022	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047108	11/12/1992	TX	73.0			F	11/05/1992	accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; this is 1 of 30 cases reported from this site; no adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	alzheimer's disease	UNK	~ ()~~~In patient	924092023	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047109	11/12/1992	TX	74.0			F	11/05/1992	accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; this is 1 fo 30 cases reported from this site; no adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	alzheimer's disease	UNK	~ ()~~~In patient	924092024	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047110	11/12/1992	TX	72.0			F	11/05/1992	accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; this is 1 of 30 cases reported from this site; no adverse effect noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	alzheimer's disease	UNK	~ ()~~~In patient	924092025	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047111	11/12/1992	TX	73.0			F	11/05/1992	accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; This is 1 of 30 cases reported from this site; no adverse effect noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	alzheimer's disease	UNK	~ ()~~~In patient	924092026	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047112	11/12/1992	TX	72.0			M	11/05/1992	Accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; This is 1 of 30 cases reported from this site; no adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	unk	alzheimer's disease	UNK	~ ()~~~In patient	924092027	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047113	11/12/1992	TX	74.0			M	11/05/1992	accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; This is 1 of 30 cases reported from this site; no adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	Alzheimer's disease	UNK	~ ()~~~In patient	924092028	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047114	11/12/1992	TX	73.0			M	11/05/1992	accidental overdose in reported in a pt receiving fluogen; pt has hx of alzheimer's disease; this is 1 of 30 cases reported from this site; No adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	alzheimer's disease	UNK	~ ()~~~In patient	924092029	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047115	11/12/1992	TX	72.0			M	11/05/1992	accidental overdose in reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; this is 1 of 30 cases reported from this site; no adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	alzheimer disease	UNK	~ ()~~~In patient	924092030	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047116	11/12/1992	TX	74.0			M	11/05/1992	accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; this is 1 of 30 cases reported from this site; no adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	alzheimer's disease	UNK	~ ()~~~In patient	924092031	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047117	11/12/1992	TX				U	11/05/1992	accidental overdose in reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; this is 1 of 30 cases reported from this site; no adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	alzheimer's disease	UNK	~ ()~~~In patient	924092032	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047118	11/12/1992	TX				U	11/05/1992	Accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; This is 1 of 30 cases reported from this site; no adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	alzheimer's disease	unk	~ ()~~~In patient	924092033	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047119	11/12/1992	TX				U	11/05/1992	accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; this is 1 of 30 cases reported from this site; no adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	alzheimer's disease	UNK	~ ()~~~In patient	924092034	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047120	11/12/1992	TX				U	11/05/1992	accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; This is 1 of 30 cases reported from this site; no adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	alzheimer's disease	UNK	~ ()~~~In patient	924092035	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047121	11/12/1992	TX				U	11/05/1992	accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; this is 1 of 30 cases reported from this site; No adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	alzheimer's disease	UNK	~ ()~~~In patient	924092036	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047122	11/12/1992	TX				U	11/05/1992	accidental overdose in reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; this is one of 30 cases reported from this site; no adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	alzheimer's disease	UNK	~ ()~~~In patient	924092037	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047123	11/12/1992	TX				U	11/05/1992	Accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimers disease; This is one of 30 cases reported from this site; No adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	alzheimer's disease	UNK	~ ()~~~In patient	924092038	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047124	11/12/1992	TX				U	11/05/1992	accidental overdose is reported in a pt receiving fluogen; pt has hx of alzheimer's disease; This is 1 of 30 cases reported from this site; No adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	alzheimer's disease	UNK	~ ()~~~In patient	924092039	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047125	11/12/1992	TX				U	11/05/1992	accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; This is 1 of 30 cases reported from this site; No adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	alzheimer's disease	UNK	~ ()~~~In patient	924092040	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047126	11/12/1992	TX				U	11/05/1992	Accidental overdose is reported in a pt receiving fluogen; pt has hx of alzheimer's disease; This is 1 of 30 cases reported from this site; No adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	alzheimer's disease	UNK	~ ()~~~In patient	924092041	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047127	11/12/1992	TX				U	11/05/1992	accidental overdose is reported in a pt  receiving fluogen; pt has hx of alzheimers disease; this is one of 30 cases reported from this site; no adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	Alzheimer's disease	UNK	~ ()~~~In patient	924092042	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047128	11/12/1992	TX				U	11/05/1992	accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; This is 1 of 30 cases reported from this site; no adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	unk	alzheimer's disease	UNK	~ ()~~~In patient	924092043	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047129	11/12/1992	TX				U	11/05/1992	accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimers disease; This is 1 of 30 cases reported from this site; no adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	Alzheimer's disease	UNK	~ ()~~~In patient	924092044	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047130	11/12/1992	TX				U	11/05/1992	accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	alzheimer's disease	unk	~ ()~~~In patient	924092045	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047131	11/12/1992	TX				U	11/05/1992	Accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; This is 1 of 30 cases reported from this site; no adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	Alzheimer's disease	UNK	~ ()~~~In patient	924092046	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047132	11/12/1992	TX				U	11/05/1992	accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; this is 1 of 30 cases reported from this site; no adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	alzheimer's disease	UNK	~ ()~~~In patient	924092047	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047133	11/12/1992	TX				U	11/05/1992	accidental overdose in reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; This is 1 of 30 cases reported from this site; no adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	alzheimer's disease		~ ()~~~In patient	924092048	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047134	11/12/1992	TX				U	11/05/1992	accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; this is 1 of 30 cases reported from this site; no adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	alzheimer's disease	UNK	~ ()~~~In patient	924092049	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047135	11/12/1992	TX				U	11/05/1992	accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; This is 1 of 30 cases reported from this site; No adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UK	alzheimer's disease	UNK	~ ()~~~In patient	924092050	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047136	11/12/1992	TX				U	11/05/1992	accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; this is 1 of 30 cases reported from this site; no adverse effects noted;									Y	10/08/1992	10/08/1992	0		OTH	OTH	UNK	alzheimer's disease	UNK	~ ()~~~In patient	924092051	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0047137	11/12/1992	MA				U		shaking, chills & seizure are reported in pt who recvd fluogen on 30OCT92; reactions occurred @ 4AM on 2NOV92 & pt was adm to hosp on 3NOV; pt d/c fully recovered;					Y	1			Y	10/30/1992	11/02/1992	3		PVT	OTH	UNK	UNK		~ ()~~~In patient	924092058	1						1	Chills; Convulsion; Tremor	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0047138	11/12/1992	IL	68.0	68		F	10/28/1992	pt recvd flu vax & w/in 24-48 hrs pt exp pruritus & devel a vesicular rash on trunk, extremities, palate & in the vaginal area; pt adm to hosp 28OCT92; MD felt may have serum sickness or stevens johnson synd;					Y				U	10/12/1992	10/13/1992	1		PUB	PVT	Azulfidine	Colitis		~ ()~~~In patient	892302001E	1						1	Dermatitis bullous; Pruritus; Serum sickness; Stevens-Johnson syndrome; Eosinophilia; Leukocytosis; Pruritus; Rash maculo-papular; Serum sickness; Stevens-Johnson syndrome	FLU3~CONNAUGHT LABORATORIES~2F31132~7+~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~2F31132~7+~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0047139	11/12/1992	PA	54.0	54		M	10/28/1992	pt recvd flu vax & 1 to 2 wks later began to exp tingling in fingers & toes, & flu-like sx; pt devel difficulty walking; pt hospitalized in ICU 21OCT92; presently has quadriplegia; tx w/plasmapheresis; ventilatory support has not been req;					Y				U	10/06/1992	10/21/1992	15		OTH	OTH			pt had malignant melanoma many yrs ago;	~ ()~~~In patient	892303001E	1						1	Back pain; Gait disturbance; Guillain-Barre syndrome; Influenza; Myalgia; Myasthenic syndrome; Paraesthesia; Quadriplegia	FLUX~PFIZER\WYETH~4928201~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0047147	11/12/1992	OK	63.0	63		F	10/30/1992	PC from MD stating pt seen 30OCT92 w/c/o itching/rash started 28OCT92 urticaria given DPH cream by MD-taking Pred; has rash on breast, neck, peri area, buttocks, lt arm antecubital area, erythema edema;										10/27/1992	10/28/1992	1		PUB	PUB	NONE	NONE	NKA	~ ()~~~In patient	OK9242	1						1	Oedema; Pruritus; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~2F31156~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~320937~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0047149	11/12/1992	SD	74.0	73		M	10/30/1992		Y	10/26/1992							N	10/13/1992	10/24/1992	11		PVT	PVT	Trazadone, Tedrol, Prosom, Buspar	chronic bronchitis-alzheimers	PCN, Novacaine-alzheimers	NONE~ ()~~~In patient		1						1	Unevaluable event	FLUX~PFIZER\WYETH~4928223~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0047151	11/12/1992	MD	63.0	63		F	11/06/1992	48 hrs p/vax pt who was initially doing well devel cough, dyspnea, CXR-LUL inflitrate; afebrile; sputum cult-no growth;			Y	Y	Y	3			Y	10/08/1992	10/10/1992	2	LUL infiltrate dx hypersensitivity pneumonitis;	PVT	PVT		chronic COPD	multiple environmental allergies, HTN			1						1	Cough; Dyspnoea; Pneumonia	FLUX~PFIZER\WYETH~4928201~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0047159	11/12/1992	OH	81.0	81		F	11/05/1992	swelling lt hand w/arthritis; muscle aches/then rt hand swelling but less so, lasting 10 days so far; sed rate 75; RF 1:20 pos;				Y						10/24/1992	10/24/1992	0		PVT	PVT	Vasotec, Tenormin, Clinoril Maside	mild hand aching on occas/hypertension		~ ()~~~In patient		1						1	Arthritis; Laboratory test abnormal; Myalgia; Oedema peripheral; Red blood cell sedimentation rate increased	FLUX~PFIZER\WYETH~4928285~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047165	11/12/1992	PA	39.0	39		F	11/03/1992	nausea, vomiting, abdominal pain, cramping, diarrhea, body aches;									Y	10/21/1992	10/21/1992	0		PVT	UNK		NONE		~ ()~~~In patient		1						1	Abdominal pain; Diarrhoea; Myalgia; Nausea; Pain; Vomiting	FLUX~PFIZER\WYETH~4928200~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047168	11/12/1992	NY	43.0	43		F	11/06/1992	hoarseness, chills, cough, malaise, fever starting 2 days p/vax;									Y	11/02/1992	11/04/1992	2	NONE	PUB	UNK		NONE	NONE	~ ()~~~In patient	NYS92069	1						1	Chills; Cough; Dysphonia; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~2F31003~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0047169	11/12/1992	OH	37.0			F		same evening devel hot feeling; 9NOV fine red rash over body & extremities, GI upset;									Y	11/06/1992	11/09/1992	3		PVT	PVT	Synthroid	NONE	allergy to PCN, Sulfa	~ ()~~~In patient		1						1	Dyspepsia; Rash; Vasodilatation	FLUX~PFIZER\WYETH~4928202~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047172	11/12/1992	CA	37.0	37		F	11/06/1992	approx 15 to 20 hrs p/vax pt devel light-headedness, tingling behind neck, & fatigue; exam neg;										11/05/1992	11/06/1992	1	HGB=14.3, HCT-41.3, WBC-9.9;	OTH	PUB	carafate	NONE	may have PUD-being eval	NONE~ ()~~~In patient		1						1	Asthenia; Dizziness; Paraesthesia	FLUX~PFIZER\WYETH~4928245~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047179	11/13/1992	PA	65.0	65		F	10/28/1992	19OCT92 noticed swollen lymph node, rt neck; 20OCT92 notice swollen lymph node, rt clavicular area, seen by MD who sent pt to surgeon;s office; 27OCT92 biopsy report from surgeon diffused bacteria in lymph node;				Y					Y	10/17/1992	10/19/1992	2	lymph node biopsy-diffused bacteria in lymph node;	PUB	PUB	Viskin, Lasix, pen	NONE	hypertension	~ ()~~~In patient	PA92307	1						1	Infection; Lymphadenopathy	FLU3~CONNAUGHT LABORATORIES~2F31149~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0047189	11/13/1992	NY	83.0	83		M	11/09/1992	laughing, talking & eating well 2NOV92; 3NOV92 wake & vomited BP 180/110, P 100; 550 became listless, BP 75/50,  P diff to count; twitching	Y	11/03/1992							N	10/28/1992	11/03/1992	6	NONE	OTH	UNK	Prozac, Synthroid, Trental, Tylenol, ASA, Senokot, Mult vit, Dulcolax;	NONE	no allergies-CVA rt hemopoisis, mild depression, plural effusions'	NONE~ ()~~~In patient		1						1	Cough; Hypertension; Hypotension; Malaise; Muscle twitching; Respiratory disorder; Vomiting	FLUX~PFIZER\WYETH~4928217~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0047196	11/13/1992	WI	71.0	70		M	11/10/1992	Freezing chills/shaking; 10NOV92 weak, pressure in stomach-thought was going to die;										11/06/1992			NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Abdominal pain; Asthenia; Chills; Tremor	FLU3~PARKE-DAVIS~00782P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0047208	11/16/1992	MO	67.0	67		F	11/05/1992	pt reports onset of sore lt deltoid & sl sore throat; no inflammation in lt deltoid area beginning 21OCT92; 22OCT92 onset of nasal congestion & nasal drainage & sore throat; 23OCT92 onset of productive cough, sputum whitish mucous; flushing									Y	10/20/1992	10/21/1992	1	NONE	PUB	PUB	Zestrial	NONE	hypertension, allergic to shellfish	NONE~ ()~~~In patient	MO92075	1						1	Cough; Injection site pain; Pharyngitis; Productive cough; Rhinitis; Vasodilatation	FLU3~PARKE-DAVIS~01772P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0047211	11/16/1992	TX	26.0	26		M	10/16/1992	fell to floor from chair, unconscious, face down, p/receiving flu vax from school nurse; yelled loudly, jumped up, threw chair, ran across room swinging @ things;									Y	10/16/1992	10/16/1992	0		OTH	PUB	NONE	NONE	NONE	~ ()~~~In patient	TX92211	1						1	Hostility; Personality disorder; Syncope	FLUX~PFIZER\WYETH~4928223~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~314912~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~2D41070~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0047213	11/16/1992	TX	44.0	44		F	10/21/1992	lt arm @ inject site- itched for 4 hrs-swelled up-got red & hot;									Y	10/19/1991	10/19/1992	366		PUB	PUB	NONE	NONE	NONE	pt exp adverse rxn @ 44 w/flu vax;~ ()~~~In patient	TX92213	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~4928207~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047217	11/16/1992	TX	38.0	38		F	10/28/1992	fever, cough, chills, & headache; some nausea;									N	10/20/1992	10/23/1992	3	NONE	PUB	PUB	birth control pills	NONE	NONE	NONE~ ()~~~In patient	TX92217	1						1	Chills; Cough; Headache; Nausea; Pyrexia	FLU3~LEDERLE LABORATORIES~337911~2~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0047219	11/16/1992	TX	86.0	86		F	11/03/1992	went to ER 24OCT92 w/rigors & chills; seen by MD who adv it was reaction to flu vax; no tx doing well now;									Y	10/23/1992	10/24/1992	1	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	TX92219	1						1	Chills	FLUX~PFIZER\WYETH~4928207~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047268	11/16/1992	MO	82.0	82		F	10/29/1992	pt had an acute myocardial infarction on 25OCT92; pt did not recover; long hx of cornary artery disease & chronic debilitation;	Y	10/25/1992							N	10/23/1992	10/25/1992	2		UNK	UNK		NONE	hx of CAD & chronic debilitation;	NA~ ()~~~In patient		1						1	Myocardial infarction	FLUX~PFIZER\WYETH~4928215~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0047273	11/16/1992	WI	63.0	62		M	11/06/1992	6NOV92 3PM trouble swallowing, very cold, shaking; 4PM MD gave DPH @ clinic; 9NOV92 pt recovered;				Y					Y	11/06/1992	11/06/1992	0		PUB	PVT		NONE	NONE	pt exp difficult swalling, cold & shaking @ 57 w/flu/pneumo vax~ ()~~~In patient		1						1	Chills; Dysphagia; Tremor	FLU3~PARKE-DAVIS~00782P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0047275	11/16/1992	CO	42.0	42		F	11/09/1992	red rash; c/o itching, hair & groin area; onset of rash 3NOV92 upon arising however itching began 31OCT92; hands were swollen & red; inject site sore for 1 day; swelling of eyes, hands, sensation of throat closing up;				Y					U	10/30/1992	11/03/1992	4		PUB	PUB	Synthroid, Cypro, Lortab	recovering/sinus surgery	amoxcillin, hx of asthma, arthritis	pt exp adverse rxn @ 41 w/flu shot 1991;~ ()~~~In patient	CO9297	1						1	Face oedema; Injection site pain; Laryngospasm; Oedema peripheral; Pruritus; Rash; Urticaria; Vasodilatation	FLUX~PFIZER\WYETH~4928287~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047278	11/16/1992	ME	74.0	73		M	11/10/1992	pt recvd vax 27OCT92 & devel itching, hives 12 hrs later then lips swelled pt seen 28OCT92 had urticaria over amrs, buttocks & foot w/angiodema of lips;									Y	10/27/1992	10/27/1992	0	NONE	PVT	PVT	methychlorthazide; anaprox	NONE	arthritis, mitralregarg, kidney stone, HBP	NKA~ ()~~~In patient		1						1	Angioneurotic oedema; Face oedema; Pruritus; Urticaria	FLUX~PFIZER\WYETH~4928227~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047279	11/16/1992	NY	75.0	75		M		day p/receiving flu shot pt became very ill w/GI problems, coughing for next 2 wks; did not see MD but remained in bed treating self;									Y	10/15/1992	10/16/1992	1	NONE	PUB	PUB		NONE		~ ()~~~In patient	MA9217	1						1	Cough; Gastrointestinal disorder	FLUX~PFIZER\WYETH~4928235~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047284	11/16/1992	WI	66.0	66		F	11/11/1992	swelling in throat-mild difficulty swallowing; redness, puffiness, & dryness of eyes; no previous h/o allergy to eggs;				Y					Y	10/22/1992	10/22/1992	0	NONE	PUB	PUB		NONE	h/o supraventricular tachycardia & rectal carcinoma	NONE~ ()~~~In patient		1						1	Conjunctivitis; Dysphagia; Face oedema; Keratitis; Laryngospasm	FLU3~PARKE-DAVIS~00882P~3~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0047285	11/16/1992	MD	57.0	57		F	11/12/1992	swelling & pain in inject site which extended to mid-arm, shoulder, & over collar bone; neck also swollen w/lymph node enlargement;				Y					Y	11/09/1992	11/10/1992	1	NA	PUB	PUB	NONE	NONE	PCN allergy, inc cholesterol	NONE~ ()~~~In patient	MD92084	1						1	Injection site oedema; Injection site pain; Lymphadenopathy; Paraesthesia	FLUX~PFIZER\WYETH~4928235~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047287	11/16/1992	MA	65.0			F	11/07/1992	13OCT92 recvd flu shot evening had chills, perspiring, bad h/a & pains from back of knees to calves of lesg; slept all day 15OCT92;									Y	10/13/1992	10/14/1992	1		PUB	UNK	PCN for tooth infect	NONE		NONE~ ()~~~In patient	MA9218	1						1	Chills; Headache; Hyperhidrosis; Pain; Somnolence; Chills; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928230~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0047289	11/16/1992	MO	48.0	48		F	11/04/1992	h/a (dull), low energy level noticed late 22OCT; 23OCT felt draggy, h/a all day; later afternoon 23OCT ached all over-muscles sore; 24OCT abdominal cramps felt like diarrhea but did not actually have that; nausea but no vomiting;									Y	10/20/1992	10/22/1992	2		PVT	PVT	Trilisate, K-tabs, lasix, Dyazide	NONE	codeine, Compazine	~ ()~~~In patient		1						1	Abdominal pain; Asthenia; Headache; Myalgia; Nausea	FLUX~PFIZER\WYETH~4928224~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047291	11/16/1992	MA	67.0			F	11/09/1992	eyes became very puffy, lost my voice; sore throat & laryngitis; tired;									Y		10/22/1992			PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MA9219	1						1	Asthenia; Dysphonia; Face oedema; Laryngitis; Pharyngitis	FLUX~PFIZER\WYETH~4928230~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047295	11/16/1992	MN	65.0	65		M	11/12/1992	acute swelling & tenderness over deltoid; no temp; dec ROM; disoriented;									Y	11/12/1992	11/12/1992	0		PVT	PVT	coumadin, Digoxin	NONE	ASHD-aortic valve replacement	~ ()~~~In patient		1						1	Confusional state; Hypokinesia; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~2F31144~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1254T~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0047296	11/16/1992	MO	36.0	35		M	11/09/1992	rash-over back & arms papular, erythema, crampy bad pain, diarrhea, arthralgia, myalgia, rigors, t38.7;									Y	10/20/1992	10/23/1992	3	NONE	PVT	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						1	Abdominal pain; Arthralgia; Chills; Diarrhoea; Myalgia; Pyrexia; Rash maculo-papular	FLUX~PFIZER\WYETH~4928224~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047308	11/17/1992	IL	75.0	75		F	11/13/1992		Y									10/16/1992	10/17/1992	1	NONE	PVT	UNK	Lasix, K-tab, Hydralazme		hypertension, moderate carotid artery stenosis, lt venous insufficiency;	~ ()~~~In patient		1						1	Unevaluable event	FLUX~PFIZER\WYETH~4928226~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0047309	11/17/1992	NC	65.0	65		M	11/04/1992	could not breath went into full arrest;	Y	11/02/1992								11/02/1992	11/02/1992	0		MIL	MIL	Colchicine HC cream, Indocin	COPD, WPW synd	procainamide, Sulfa	~ ()~~~In patient		1						1	Apnoea; Cardiac arrest	FLUX~PFIZER\WYETH~4928209~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0047310	11/17/1992	NC	76.0	76		F	11/04/1992	found on floor @ home in full arrest;	Y	11/03/1992							N	11/02/1992	11/03/1992	1		PVT	PVT	Insulin, Clinoril med, for hypertension;	diabetes/hypertension		~ ()~~~In patient		1						1	Apnoea; Cardiac arrest	FLU3~CONNAUGHT LABORATORIES~2F311704~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0047317	11/17/1992	MO	73.0	73		F	10/06/1992	pt felt hot-temp not measured; had some wheezing/asthma; very sore throat, SOB;									Y	09/17/1992	09/19/1992	2		PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Asthma; Dyspnoea; Pharyngitis; Pyrexia	FLU3~LEDERLE LABORATORIES~335994~UNK~SC A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0047326	11/18/1992	ID	74.0	74		F	10/30/1992	eyes feeling funny, eyes swollen shut, itching of eyes, achiness & feverish; DPH given; pt seen by MD 28OCT92; dx as allergic reaction to different eye shadow used on 26OCT92; pt given topical cream which cleared this;				Y					Y	10/26/1992	10/26/1992	0	NA	PUB	PUB	NA	NA	PNC, hairspray & cosmetics;	NA~ ()~~~In patient	ID92069	1						1	Condition aggravated; Face oedema; Myalgia; Pruritus; Pyrexia	FLUX~PFIZER\WYETH~4928231~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047337	11/18/1992	WI	62.0	62		M	11/09/1992	devel severe chest & head congestion w/fever; p/4 days of no response treated w/supra 10 days;				Y					Y	10/01/1992	10/08/1992	7	NONE	PUB	PUB	Minipress, Salacate, Hydrochlorthiazide	NONE	hypertension, arthritis	pt exp chest & head congestion w/fever w/flu vax;~ ()~~~In patient		1						1	Lung disorder; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~00582P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~316923~UNK~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0047338	11/18/1992	AK	9.0	9		F	11/13/1992	local swelling around inject site rt deltoid w/swelling 7cmx7cmx1cm thick; tender rt axillary lymph node 1 cm local warmth; sl fatigue lasted 3 days;									Y	11/03/1992	11/05/1992	2	NONE	PVT	PVT	NONE	NONE	frequent injections	~ ()~~~In patient		1						1	Asthenia; Injection site oedema; Lymphadenopathy; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~2F3156~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0047342	11/19/1992	IL	45.0			F	11/04/1992	6 hrs p/fluzone pt reported heart palpitation, chest pain; chest & back ache; denied SOB; went to ER 3NOV92 in the evening for heart palpitations again; pt states EKG & CXR ok; was referred to cardiologist;				Y					Y	10/31/1992	10/31/1992	0	seen in ER 3NOV92 CXR & EKG per patient;	OTH	UNK		NONE	states she does not have pvt MD	~ ()~~~In patient	IL92104	1						1	Back pain; Chest pain; Palpitations	FLU3~CONNAUGHT LABORATORIES~2F31112~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0047343	11/19/1992	NM	74.0	74		F	11/03/1992	pt recvd flu vax @ 10AM; pt denied egg allergy & neuro problems; 1030AM pt exp swelling on lt deltoid sl above & to lt of inject site; @ 1050 wheal & redness were noted on pt's chest & upper back & swelling on deltoid had inc; MD was notifi									Y	11/03/1992	11/03/1992	0		OTH	PUB		NONE	Seldane	~ ()~~~In patient	NM92015	1						1	Injection site oedema; Urticaria; Vasodilatation	FLUX~PFIZER\WYETH~4928218~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047346	11/19/1992	NC	67.0	67		F	11/05/1992	arms & legs ached like a virus & was in bed x 2 days; very tired, equilibrium off, sore head still; 1 wk p/vax started a lump or puffy area appeared in LUQ abdomen, itched; seen by MD on 3NOV92 given Lodine;				Y					Y	10/15/1992	10/17/1992	2	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	NC92080	1						1	Asthenia; Coordination abnormal; Headache; Myalgia; Pruritus; Skin nodule	FLU3~PARKE-DAVIS~01672P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0047349	11/19/1992	RI	69.0	69		F	11/12/1992	arm became very red to elbow-very hard @ touch-very hot; administered ice-about 6 hrs p/shot did not help-did call ER & visited next day; nurse stated local rxn-cont w/vax next yr; itchy-swollen;									Y	11/01/1992	11/01/1992	0		PUB	OTH	NONE	NONE	PCN, APAP, Demerol, Makeup, soaps, Nylon	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~4928201~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047351	11/19/1992	FL	61.0	61		F	11/11/1992	2NOV92 pt recvd flu shot lot# 4928285 which devel into a red, edematous, warm area on rt deltoid; this began on 4NOV92 pt called office & came in for check up on 6NOV92; dx local reaction to flu shot; t98.3, p80, BP 160/98 on 6NOV92;									Y	11/02/1992	11/04/1992	2	NA	UNK	PVT	Micronase, Zestril, Meclizine, Tranxene;	NONE	codeine, Iodine;	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLUX~PFIZER\WYETH~4928285~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~CONNAUGHT LABORATORIES~2D41070~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0047355	11/19/1992	IL	45.0			F	11/12/1992	bil hand grip weakness & paresthesia begn 48 hrs post vax; resolved w/o rx w/in 2 wks;									Y	10/22/1992	10/23/1992	1	EMG, MRI, C-spine nl;	PUB	UNK	NONE	bil hand weakness & paresthesia	NONE	~ ()~~~In patient		1						1	Myasthenic syndrome; Paraesthesia	FLU3~PARKE-DAVIS~00192P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0047358	11/20/1992	WI	27.0	27		M	11/03/1992	pt recvd flu vax & exp numbness on the rt side of body (arm & leg); pt is being evaluated for GBS;									U	11/01/1992	11/01/1992	0		OTH	OTH				~ ()~~~In patient	892310003E	1						1	Chills; Influenza; Nausea; Paraesthesia	FLUX~PFIZER\WYETH~4928147~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047362	11/20/1992	CO	35.0	35		F	11/09/1992	2 days p/vax face swelled & had a rash (only on the face) like a bad sunburn seen by MD;				Y					U	11/05/1992	11/07/1992	2	NONE	PUB	PUB		NONE	respiratory allergies-dust animal dander	NONE~ ()~~~In patient	CO92092	1						1	Face oedema; Rash	FLU3~CONNAUGHT LABORATORIES~4928017~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0047366	11/20/1992	MD	28.0	28		M	10/05/1992	318PM c/o dizziness & flushed feeling in face; stated feel like my face is burning up; BP 320PM 128/84, P80; 337PM 118/72;									Y	10/02/1992	10/02/1992	0		PUB	PUB		denies	denies	~ ()~~~In patient	MD92077	1						1	Dizziness; Pain; Vasodilatation	FLUX~PFIZER\WYETH~4928146~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047379	11/20/1992	TN	40.0	40		M	11/06/1992	chills, t102, muscle aches, nausea, loss of appetite, sore throat; pt's daughter was dx w/strep throat 2 wks ago;				Y					U	11/05/1992	11/05/1992	0	NA	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	TN92146	1						1	Anorexia; Chills; Myalgia; Nausea; Pharyngitis; Pyrexia	FLUX~PFIZER\WYETH~4928233~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047381	11/20/1992	OR	77.0			F	10/27/1992	MD states ran high fever 2 days p/vax was freezing cold; lt arm hurt to touch; chest-lt leg burning & painful like paralized; pain relieved by heat; fever still present a wk p/shot;														UNK	PVT		COPD	PCN, sulfa pollen	~ ()~~~In patient		1						1	Chills; Pain; Pyrexia	FLUX~PFIZER\WYETH~4928231~3~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046331	11/23/1992	IA	76.0	76		F	11/20/1992	pt recvd vax 16SEP92 on 25SEP92 exp shaking, chills, & sweats, followed by rt facial tingling & lt arm & leg tingling, ataxia, dysphagia, slurred speech, inability to void & constipation; hospitalized on 26SEP92; atrial fibrillation; GBS,					Y	12			U	09/16/1992	09/25/1992	9	26SEP92 MRI brain, nondiagnostic; 29SEP92 LP protein 66; glucose nl; Nerve conduction studies peripheral neuropathy; heavy metal screening unremarkable; 6OCT92 LP-protein 54; glucose 78; RBC, WBC=0;	PVT	PVT	Dyazide, APAP extra strength, Metamucil, Disalcid		allergy clinoril; allergy Naprosyn	~ ()~~~In patient	WAES92110110	1						2	Atrial fibrillation; Cerebrovascular accident; Coordination abnormal; Encephalitis; Guillain-Barre syndrome; Neuropathy peripheral; Paraesthesia; Respiratory disorder; Atrial fibrillation; CSF test abnormal; Neuropathy peripheral; Paraesthesia; Respiratory disorder; Speech disorder; Tachycardia; Urinary retention	FLUX~PFIZER\WYETH~4928224~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~7121530T~UNK~~~PNEUMO (PNEUMOVAX)~1|FLUX~PFIZER\WYETH~4928224~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~1530T~UNK~~~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0047389	11/23/1992	CA	56.0	56		F	11/10/1992	pt reported had tenderness in lt upper arm the day p/the inject; a few days later pt noticed a dull aching pain in same site w/certain movements such as reaching behind back to hook bra on raising arm up;									U	10/15/1992	10/16/1992	1	NONE	PUB	PUB	NONE	NONE	fibro cystic disease	~ ()~~~In patient	CA92135	1						1	Injection site pain	FLUX~PFIZER\WYETH~4928234~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047390	11/23/1992	CA	69.0	69		F	11/12/1992	5NOV watery eyes-1 wk a/ER; 11NOV paralysis to rt side face-dx bell's palsey to ER;				Y					N	11/02/1992	11/05/1992	3		PUB	PUB	Tomoptic drops, Tamoxifen, Diazide;	NONE	hx of CA high blood pressure	~ ()~~~In patient	CA92136	1						1	Facial palsy; Lacrimal disorder	FLUX~PFIZER\WYETH~4928271~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047391	11/23/1992	CA	42.0	42		F	11/05/1992	rash on face, neck & chest w/low grade fever 3-6 days p/flu inject; sores in mouth resembling thrush w/peeling skin in mouth; swollen lymph nodes; gained 7 lbs about 8-10 days p/shot;									Y	10/22/1992	10/26/1992	4	NONE	PUB	PUB	Ibuporfen	NONE	arthritis	NONE~ ()~~~In patient	CA92137	1						1	Dermatitis exfoliative; Lymphadenopathy; Mouth ulceration; Oral candidiasis; Pyrexia; Rash; Weight increased	FLUX~PFIZER\WYETH~4928234~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047392	11/23/1992	CA	65.0	65		F	11/09/1992	26OCT AM had sx of bladder infection but no fever; got flu shot; 3PM pain in back & breast & seen by MD for bladder infect; 28OCT pain cont so seen by MD did x-ray sx pleurisy; MD not sure if vax related; 9NOV92 pt feeling tired;				Y					Y	10/26/1992	10/26/1992	0		PUB	PUB	Premarin; NPH Humelin Insulin;	sx of bladder infection	Insulin dependent diabetes; metastic adenocarcinoma (sites unk); chronic ear infect; arthritis;	NONE~ ()~~~In patient	CA92138	1						1	Asthenia; Back pain; Breast pain; Condition aggravated; Pain; Pleural disorder	FLUX~PFIZER\WYETH~4928219~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047393	11/23/1992	CA	67.0	67		F	11/05/1992	pt recvd flu shot 6OCT92 on 17OCT92 pt had c/o sinus drainage, sore throat, chest congestion, & cough; pt tx'd w/ATB by MD;				Y					U	10/06/1992	10/17/1992	11	dx by MD as having virus;	OTH	PUB	Hypothyroid med	NONE	arthritis, hypothyroidism	NONE~ ()~~~In patient	CA92139	1						1	Cough; Infection; Lung disorder; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4928219~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047396	11/23/1992	CA	70.0	70		M	11/03/1992	pt recvd flu vax on 26OCT92 & arm is not red, hot, tender, swollen-6-7 cm in size; MD placed pt on DPH & ATB; swelling gone 1 wk later-just sore;									Y	10/26/1992	10/27/1992	1	NONE	PUB	PUB		NONE	cirrohsis of liver-ascities	~ ()~~~In patient	CA92142	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~LEDERLE LABORATORIES~4928234~UNK~IM~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0047400	11/23/1992	CO	24.0	24		F	10/19/1992	left work 4PM felt tired; decided to take nap; cont to sleep through noc; spouse took to ER 10OCT in AM; seen by MD pt reports feeling exhausted like had been up for 2 days; @ ER pt threw up;				Y					Y	10/09/1992	10/09/1992	0	NONE	PUB	PVT	Mega vitamins; Protein supplement;	NONE	believes has numerous allergies;	pt exp lightheaded @ 24 w/measles booster;~ ()~~~In patient	CO9285	1						1	Asthenia; Vomiting	FLUX~PFIZER\WYETH~4928223~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047402	11/23/1992	CO	72.0	72		F	10/26/1992	tc from pt on 23OCT92 1101AM reports havin a flu shot 1 wk ago & had chills, sweats, pain & dizziness has been taking Ubuporfen since that time; speech was noticeable slurred;				Y	Y					10/15/1992	10/15/1992	0	dx on 24OCT92 group B strept meningitis;	PUB	PUB	Synthoid, Premarin		pitocin allergy; mitral valve vegetation	~ ()~~~In patient	CO9287	1						1	Arthralgia; Chills; Dizziness; Hyperhidrosis; Infection; Meningitis; Speech disorder	FLUX~PFIZER\WYETH~4928207~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0047409	11/23/1992	IL	83.0	83		M	11/12/1992	devel redness & swelling @ site; 7-8 days p/inject;									Y	10/16/1992	10/24/1992	8	NA	PUB	PUB		NONE	NONE	~ ()~~~In patient	IL92105	1						1	Injection site hypersensitivity; Injection site oedema	DT~PFIZER\WYETH~4928070~1~IM~RA~DT ADSORBED (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928215~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047413	11/23/1992	KS	33.0	33		F	11/03/1992	urticaria, raised rash over face; swelling @ inject site, white blotches all around inject site;									Y	10/29/1992	10/29/1992	0	NONE	PUB	PUB	NONE	NONE	codiene, PNC	~ ()~~~In patient	KS92069	1						1	Injection site hypersensitivity; Injection site oedema; Rash; Urticaria	FLU3~PARKE-DAVIS~00292P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0047414	11/23/1992	KS	42.0	42		F	10/22/1992	2x3 red area @ sight of inject; fever, nausea;				Y					Y	10/16/1992	10/18/1992	2		PUB	PUB		NONE	UNK	UNK~ ()~~~In patient	KS92070	1						1	Injection site hypersensitivity; Nausea; Pyrexia	DTP~CONNAUGHT LABORATORIES~2A41126~UNK~~LA~DTP (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928114~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047415	11/23/1992	NC	35.0	35		F	11/02/1992	fever, abd pain, hoarseness, vomiting;									U	10/27/1992	10/28/1992	1	NONE	PUB	PUB	stelazine	NONE	nerve problems according to pt	NONE~ ()~~~In patient	NC92077	1						1	Abdominal pain; Dysphonia; Pyrexia; Vomiting	FLUX~PFIZER\WYETH~4928146~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047419	11/23/1992	NH	42.0	41		M	11/09/1992	12 hrs p/vax woke up w/chills, muscle aches & h/a; these sx lasted approx 12 hrs; had only dull h/a the following day;									Y	11/06/1992	11/07/1992	1	NA	PUB	PUB	NA	NA	chronic sinisitis	~ ()~~~In patient	NH92014	1						1	Chills; Headache; Myalgia	FLU3~CONNAUGHT LABORATORIES~2F31169~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0047422	11/23/1992	NC	86.0			F		fever to 105 <24 hrs p/flu shot; adm to hosp, no abn test noted to explain fever;					Y					10/26/1992	10/27/1992	1	VIA-nl; CXR-nl; CBC-nl;	UNK	UNK	Darvocet, Symmetrel;		allergy codeine; dx tremor, back pain, cervical arthritis, atrophic cystitis, hypertension;	~ ()~~~In patient		1						1	Pyrexia	FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0047440	11/23/1992	ME	58.0	58		F	11/17/1992	2 days following vax had temp, chills, aches, vomiting, swollen lips;									Y	11/06/1992	11/08/1992	2	NONE	PVT	PVT	Reglan, Augmentin short term, Lithium, Doxipin, Miconase	infection rt great toes;	NKA	NA~ ()~~~In patient		1						1	Chills; Face oedema; Myalgia; Pyrexia; Vomiting	FLUX~PFIZER\WYETH~4928227~4~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047441	11/23/1992	NY	37.0	37		F	11/18/1992	severe h/a, nausea, vomiting, weakness, dazed, chills, passing out, cold like sx; lt arm pain & numbness up to lt side neck;									Y	11/16/1992	11/16/1992	0		UNK	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Asthenia; Headache; Paraesthesia; Pharyngitis; Rhinitis; Stupor; Syncope; Vomiting	FLU3~CONNAUGHT LABORATORIES~2F31003X~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SMITHKLINE BEECHAM~10532A2~4~IM~RA~HEP B (ENGERIX-B)~1	USA		Influenza
0047443	11/23/1992	MO	54.0	54		F	11/17/1992	devel red rash raised; itching @ inject site; took DPH for it;									Y	10/26/1992	10/28/1992	2	NONE	PVT	PVT	Premarin, Provera;	NONE	NONE	~ ()~~~In patient		1						1	Pruritus; Rash maculo-papular	FLUX~PFIZER\WYETH~4928214~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047444	11/23/1992	TX	43.0	42		U	11/18/1992	general malaise-local erythma @ site & erythma of opposite arm;									Y	10/28/1992	10/29/1992	1		UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Malaise; Rash	FLU3~CONNAUGHT LABORATORIES~2F31143~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0047445	11/23/1992	TX	29.0	29		F	11/18/1992	4x4 cm area of erythma @ inject site;									Y	11/03/1992	11/04/1992	1		UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~2F31143~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0047446	11/23/1992	TX				M	11/18/1992	generalized erythma;									Y	10/28/1992	10/28/1992	0		UNK	UNK				~ ()~~~In patient		1						1	Headache; Rash; Hyperhidrosis; Syncope	FLU3~CONNAUGHT LABORATORIES~2F31143~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~LEDERLE LABORATORIES~335915~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~3	USA		Influenza
0047447	11/23/1992	TX	46.0	46		F	11/18/1992	2x2 cm area of erythma, induration & tenderness;									Y	10/26/1992	10/28/1992	2		UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~CONNAUGHT LABORATORIES~2F31143~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0047448	11/23/1992	TX	35.0	35		M	11/18/1992	5x6cm erythma & tender induration @ inject site;									Y	10/26/1992	10/27/1992	1		OTH	OTH				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~CONNAUGHT LABORATORIES~2F31143~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0047449	11/23/1992	TX	28.0	28		F	11/18/1992	erythma @ inject site; SOB, myalgia, malaise;									Y	10/27/1992	10/29/1992	2		UNK	UNK			hypertension, migraine cedhalgia	~ ()~~~In patient		1						1	Dizziness; Dyspnoea; Injection site hypersensitivity; Malaise; Myalgia; Somnolence	FLU3~CONNAUGHT LABORATORIES~2F31143~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0047450	11/23/1992	TX	41.0	41		F	11/18/1992	induration @ inject site;									Y	10/26/1992	10/26/1992	0		UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~2F31143~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0047451	11/23/1992	TX	30.0	30		M	11/18/1992	multi area of erythma on upper trunk;									Y	10/26/1992	10/28/1992	2		OTH	OTH				~ ()~~~In patient		1						1	Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~2F31143~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0047452	11/23/1992	TX	27.0	27		F	11/18/1992	4x6cm erythma & induration @ inject site along w/malaise, myalgia;									Y	10/26/1992	10/28/1992	2		PUB	PUB				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Malaise; Myalgia	FLU3~CONNAUGHT LABORATORIES~2F31143~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0047453	11/23/1992	TX	31.0	31		F	11/18/1992	5x5cm area of erythma @ inject site;									Y	10/26/1992	10/28/1992	2		OTH	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~2F31143~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0047454	11/23/1992	TX	38.0	38		F	11/18/1992	4x6cm erythma & induration @ inject site;									Y	10/26/1992	10/28/1992	2		OTH	PUB				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~2F31143~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0047455	11/23/1992	TX	29.0	29		M	11/18/1992	6x6 cm area of erythema & induration @ inject site;									Y	10/26/1992	10/28/1992	2		OTH	PUB				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~2F31143~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0047456	11/23/1992	TX				U	11/18/1992	4cm erythma & edema @ inject site;									Y	10/26/1992	10/26/1992	0		OTH	PUB				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~2F31143~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0047457	11/23/1992	CA	66.0	66		F	11/16/1992	flu shot 5NOV92 & w/in 24 hrs of shot w/hives on body, legs, & behind knees; pt hx of allergies to PCN & sulfur; MD called said probably reaction to flu shot rx fr itchiness to rash 16NOV92;									Y	11/05/1992	11/06/1992	1	NONE	UNK	PUB	Preveran & estrase	NONE	allergies to MSL & BHT & sulphat	NONE~ ()~~~In patient	CA92146	1						1	Pruritus; Urticaria	FLUX~PFIZER\WYETH~4928271~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047446	11/24/1992	TX	6.0	6		M	10/28/1992	almost immediately p/inject of flu pt fell hit face passed out; was perspiring afterwards;									Y	10/28/1992	10/28/1992	0		PVT	UNK		NONE	bronchitis	~ ()~~~In patient		1						3	Headache; Rash; Hyperhidrosis; Syncope	FLU3~CONNAUGHT LABORATORIES~2F31143~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~LEDERLE LABORATORIES~335915~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~3	USA		Influenza
0047463	11/24/1992	VA	59.0	59		F	11/09/1992	the evening p/the inject that AM pt had 2 reddened areas on rt arm the size of a fifty cent piece about 2 inches apart; pt felt hot; pt had chills, felt weak, had tickling cough; t102 for 3 hrs; arm was sore;									Y	10/20/1992	10/20/1992	0	NONE	PUB	PUB	PPD by Parke Davis lot# 01982P given 20OCT92;	had been ill 2 wks prior to vax		~ ()~~~In patient	VA92117	1						1	Asthenia; Chills; Cough; Myalgia; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~2F31148~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~330949~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0047468	11/24/1992	WA	66.0	66		M	11/12/1992	apparently devel GBS approx 1 wk following admin of flu vax;				Y	Y		Y		U	10/09/1992	10/15/1992	6	UNK	OTH	OTH	NONE	mild URI	NONE	~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLUX~PFIZER\WYETH~4928231~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~308909~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0047469	11/24/1992	MA	26.0	26		M	11/10/1992	@ time vax given, stated had sx of URI, temp below 98.6; URI sx have inc since vax given; h/a, generalized backache, nausea (no vomiting); temp ranging 99.2-100 po; also sore throat; seen @ clinic;				Y					Y	11/03/1992	11/06/1992	3		PVT	PUB	NONE	URI sx	denied	~ ()~~~In patient		1						1	Back pain; Condition aggravated; Headache; Nausea; Pyrexia	FLUX~PFIZER\WYETH~4928226~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0046704	11/25/1992	PA	64.0	64		F	11/12/1992	pt died suddenly in sleep early AM 3OCT92;	Y	10/03/1992							N	10/02/1992	10/03/1992	1	NONE	PUB	PVT	UNK	NONE	UNK	UNK~ ()~~~In patient	PA92329	1						2	Cardiac arrest; Unevaluable event	FLU3~PARKE-DAVIS~01272P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~01272P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Results in Death	Influenza
0047474	11/25/1992	ME	24.0	23		F	11/09/1992	pt recvd flu vax & devel flu-like sx; the following morning pt collapsed & was adm to the hosp; pt is on a respirator & is critically ill;	Y		Y		Y				N	11/05/1992				OTH	OTH		hodgkins disease/asplenic	pt had hodgkins disease & is asplenic;	~ ()~~~In patient	892315007E	1						1	Endocarditis; Influenza; Shock	FLUX~PFIZER\WYETH~4928115~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0047475	11/25/1992	CA				M	11/04/1992	pt inadvertently recvd 5 ml (instead of 0.5ml) flu vax & exp erythema @ the inject site & resp distress; pt was recovering from pneumonia @ the time of vax;									U	11/04/1992	11/04/1992	0		OTH	OTH		resp problems	pt had past hx resp problems & was recovering from pneumonia @ the time of vax;	~ ()~~~In patient	892314001E	1						1	Condition aggravated; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047476	11/25/1992	NJ	10.0	10		F	11/09/1992	Pt recvd flu vax 6 days later devel resp distress & was hospitalized; has been discharged from the hosp & still exp tightness in the chest & spasm of the vocal chords;				Y	Y	6			U	10/05/1992	10/26/1992	21		PVT	PVT			the pt is otherwise healthy w/no known chronic or debilitating illnesses;	~ ()~~~In patient	892315008E	1						1	Chest pain; Condition aggravated; Dyspnoea; Laryngospasm	FLUX~PFIZER\WYETH~4928229~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0047477	11/25/1992	TX	25.0	25		F	11/14/1992	numbness in both feet on 3NOV92, then on 5NOV92 was out of work for kidney infection & hospitalized on 8NOV92; in critical condition now in hosp w/resp assistance through tracheostomy;			Y		Y		Y		N	10/23/1992	11/03/1992	11	AG GBS on 9NOV92, CFS taken;	UNK	UNK				~ ()~~~In patient	CO4527	1						1	Dyspnoea; Guillain-Barre syndrome; Laboratory test abnormal; Paraesthesia; Urinary tract disorder	FLU3~CONNAUGHT LABORATORIES~2F31156~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0047478	11/25/1992	CA	19.0	19		M	11/18/1992	30 hrs post inject had a resp failure & was put on a respirator; no other organs involved; severe eosinophilia, lung biopsy showed eosinophilic infiltration; tx w/pred & improved & removed from ventilator on 18NOV92; will do skin testing i;			Y		Y				N	11/05/1992	11/06/1992	1		UNK	UNK				~ ()~~~In patient	CO4538	1						1	Apnoea; Eosinophilia; Laboratory test abnormal; Pneumonia; Respiratory disorder	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0047481	11/25/1992	DE	52.0	52		F	11/16/1992	devel fever & fell asleep awoke w/severe pain in back; severe pain inthe rt upper extremity; hand & arm are numb; thumb & under finger very numb; now has golf balls in the back of neck (muscles); numerous MD visit;				Y					N	11/05/1992	11/05/1992	0	MRI	PUB	PUB	HTZ, Concord	angina & hypertension	heart condition	NA~ ()~~~In patient	DE929	1						1	Back pain; Pain; Paraesthesia; Pyrexia; Subcutaneous nodule	FLUX~PFIZER\WYETH~4928226~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~328929~UNK~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0047492	11/25/1992	PA	68.0	68		F	11/12/1992	3OCT92 seen in Er admitted to hosp;	Y	10/04/1992		Y	Y	1			N	10/02/1992	10/03/1992	1	UNK	PUB	PVT	UNK	NONE	UNK	UNK~ ()~~~In patient	PA92327	1						1	Unevaluable event	FLU3~PARKE-DAVIS~01272P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0047493	11/25/1992	PA	74.0	74		F	11/12/1992	pt seen in ER where died 3OCT92;	Y	10/03/1992		Y					N	10/02/1992	10/03/1992	1	UNK	PUB	PVT	UNK	NONE	UNK	UNK~ ()~~~In patient	PA92328	1						1	Unevaluable event	FLU3~PARKE-DAVIS~01272P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0047502	11/25/1992	MA	72.0			F		chills, shaking x 2 hrs devel cold sores on lips;									Y				NONE	UNK	PUB		NONE	in good hlth	NONE~ ()~~~In patient		1						1	Chills; Herpes simplex; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046652	11/30/1992	PA	49.0	48		M	10/23/1992	pt reported via phone on 21OCT92 that devel rash, hives & nausea 1 day p/recvd flu vax;									Y	10/05/1992	10/06/1992	1	NONE	PVT	UNK	Dilantin-Phenobarb	neg	seizure disorder, cardiac valvular	neg~ ()~~~In patient		1						2	Nausea; Rash; Urticaria; Nausea; Rash; Urticaria	FLU3~LEDERLE LABORATORIES~337909~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|FLU3~LEDERLE LABORATORIES~337909~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~2	USA		Influenza
0047509	11/30/1992	NJ	57.0	56		M	11/04/1992	pt vax 29OCT92 approx 48 hrs later, exp grand mal seizure; hopsitalized 3 days for complete work-up cardiac monitoring for 3 days revealed no arrhythmias; MRI & CAT scan of brian was nl; EEG-nl pt has no risk factors;					Y	3			U	10/29/1992	10/31/1992	2	NA	PVT	PVT	NA		nine other pts were immunized from the same vial	NA~ ()~~~In patient	920373001	1						1	Grand mal convulsion	FLU3~LEDERLE LABORATORIES~337934~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation	Influenza
0047512	11/30/1992	CA	86.0			F	10/30/1992	pt recvd flu vax 7NOV92 & exp resp distress a few days later (approx 10NOV91) pt devel pneumonia & was hospitalized (dat unk); following hospitalization pt suffered a stroke;					Y				Y	11/07/1991	11/10/1991	3		OTH	OTH		NONE		~ ()~~~In patient	892325001E	1						1	Cerebrovascular accident; Dyspnoea; Pneumonia	FLUX~PFIZER\WYETH~~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0047516	11/30/1992	ME	28.0	27		F	11/23/1992	dizzy, faint, fever not high; 24 hrs duration vomiting every 1/2 hr; stomach pains from vomiting; (mom sick @ home today w/sx of chill, cold etc); took compazine for nausea; called MD for tx;				Y					Y	11/18/1992	11/20/1992	2	NONE	PUB	UNK	NONE	NONE		NONE~ ()~~~In patient	ME92022	1						1	Abdominal pain; Dizziness; Nausea; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~2F31156~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0047517	11/30/1992	ME	44.0	43		F	11/19/1992	joint pain leading to disablement of joint function; could not walk during day; knees, ankles, wrist & hand joint did not affect shoulders, hips & elbows; joint pain in feet; stiffness, h/a;				Y					N	10/27/1992	11/01/1992	5	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	ME92024	1						1	Arthralgia; Headache; Hypokinesia; Nuchal rigidity	FLU3~PARKE-DAVIS~01972P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0047518	11/30/1992	ME	72.0	72		F	11/09/1992	sneezing seen by MD very sick, cough, fever, ached all over; ATB coughs now chest; bronchial trouble, improved;				Y					N	11/04/1992	11/05/1992	1	NONE	OTH	UNK	NONE	usual health	osteoporosis/bronchial trouble	pt exp rxn w/flu shots & pneumonia vax;~ ()~~~In patient	ME92025	1						1	Cough; Myalgia; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~4928115~1~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047519	11/30/1992	ME	41.0	41		F	11/19/1992	shot on Thursday & Friday PM sore throat, swollen glands, joint achiness, throat, chest, asthma, URI & sinusitis; still has some illness; still coughing p/ 2 wks; very tired had ATB for sinus;				Y					N	11/05/1992	11/06/1992	1	NONE	PUB	OTH	ATB for sinus	NONE	Not known	Not known~ ()~~~In patient	ME92026	1						1	Arthralgia; Asthenia; Asthma; Cough; Lymphadenopathy; Pharyngitis; Sinusitis	FLUX~PFIZER\WYETH~4928227~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047520	11/30/1992	ME	49.0	49		F	11/19/1992	sick for 2 wks tickle in throat-cough seen by MD 16NOV; MD gave ATB & DPH for reaction to ATB; diarrhea & aches & pains;				Y					N	10/26/1992	11/01/1992	6	test for virus or flu; intestinal virus;	OTH	OTH	pub	NONE	NONE	NONE~ ()~~~In patient	ME92027	1						1	Cough; Diarrhoea; Infection; Myalgia; Pain	FLUX~PFIZER\WYETH~4928227~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047521	11/30/1992	ME	57.0	57		F	11/19/1992	onset @ MN fever, sweaty, nauseated, really ached; w/o vomiting, h/a, arm felt funny, red, sweat, & chills; lasted for weekend; didn't see MD taking PCN in exposure to strep throat;									N	11/12/1992	11/12/1992	0	NONE	PUB	OTH	ATB for prevention since 15NOV;	general aches, not feeling well	NONE	NONE~ ()~~~In patient	ME92028	1						1	Chills; Headache; Hyperhidrosis; Myalgia; Nausea; Pyrexia; Vasodilatation	FLUX~PFIZER\WYETH~4928115~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047522	11/30/1992	MO	70.0	70		F	11/03/1992	29OCT92 generalized weakness prostration chills, fevers x 4 days; t99.4; 2NOV92 has not improved significantly-admitted to ER-nausea & vomiting;				Y					Y	10/27/1992	10/27/1992	0	WBC 13,600; Seg 76%;	PUB	PUB		NONE		~ ()~~~In patient	MO92080	1						1	Asthenia; Chills; Leukocytosis; Nausea; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~01772P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0047524	11/30/1992	OK	78.0	78		F	11/12/1992	pt reports immediate itching & hives 10NOV92 severe allergic reaction displaced rt arm lateral to inner aspect; vax given rt deltoid; 8 x 5 area immediately below (2) visualized site of inject-reddened, pt reports terrible itching;									Y	11/10/1992	11/10/1992	0	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	OK9244	1						1	Hypersensitivity; Injection site hypersensitivity; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~2F31171~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~320937~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0047530	11/30/1992	MO	23.0	23		F	11/24/1992	45 mins p/receiving flu vax started feeling heaviness in chest, then started vomiting then heart rate got fast then slowed down-exp chest tightness & SOB; next Am HR 130, felt better went to work, vomited again HR elevated 140-169;				Y	Y	2			Y	10/26/1992	10/26/1992	0	UNK	PUB	PVT	Lopid	NONE	hx tachycardia	UNK~ ()~~~In patient		1						1	Chest pain; Condition aggravated; Dyspnoea; Vomiting	FLUX~PFIZER\WYETH~49281215~1~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0047537	11/30/1992	MO	69.0	69		F	11/16/1992	Pt recvd flu vax 15OCT92 & 16-18OCT pt had minor pain in legs; 19-20OCT pt in bed 18 hrs extreme fatigue, exhaustion, weakness, t98, muscle aching; 26OCT seen by MD had lung xray & EKG; 2NOV felt normal;				Y					Y	10/15/1992	10/19/1992	4	Lung xray, EKG, Hematology, HIV Antibody, Chem, Blood Lipid Profile all normal;	PUB	PVT	Diazapam	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Myalgia; Pain	FLUX~PFIZER\WYETH~4928114~6~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047540	11/30/1992	CO	35.0			F	11/19/1992	swelling, itching & induration devel about inject site w/in 1 hrs of inject; swelling cont to inc to 12cm x 10cm area w/in 48 hrs;				Y					U	11/17/1992	11/17/1992	0	NONE	MIL	MIL	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site mass; Injection site oedema; Pruritus	FLUX~PFIZER\WYETH~4928239~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047542	11/30/1992	OH	39.0	39		F	11/23/1992	pt recvd vax 6NOV92 in lt deltoid; 7NOV area blistered red & swollen-ulcer area noted burning down arm; rx in ER given ATB & med for pain;				Y					Y	11/06/1992	11/07/1992	1	Blood cult-neg; CBC-nl;	PUB	UNK		NONE	sulfa-codeine	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site reaction; Pain; Skin ulcer	FLU3~CONNAUGHT LABORATORIES~2F31133~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0047546	11/30/1992	CT	21.0	21		F	11/17/1992	pt describes swelling, redness @ inject site lt arm; other sx included fever, vomiting, couldn't move arm;				Y					Y	11/05/1992				PUB	PUB			NKA	NA~ ()~~~In patient	CT9202	1						1	Hypokinesia; Injection site hypersensitivity; Injection site oedema; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~2F31150~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~318916~UNK~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0047549	11/30/1992	WI	63.0	63		F	11/16/1992	area size of fifty cents, blister like on lt shoulder-burns & itches; pain started 10 mins p/flu vax; seen by MD no tx;				Y						11/05/1992	11/05/1992	0	NONE	PUB	PUB		anemia	NONE	~ ()~~~In patient		1						1	Dermatitis bullous; Pain; Pruritus	FLU3~PARKE-DAVIS~00882P~2~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0047557	11/30/1992	CA	42.0	42		F	11/18/1992	urticarial rash arms, ant & post trunk 15-20 mins p/receiving flu vax x 2 days, relieved w/Atarax;									Y	11/17/1992	11/17/1992	0	NONE	OTH	PVT		NONE	NONE	NONE~ ()~~~In patient		1						1	Urticaria	FLUX~PFIZER\WYETH~4928166~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047562	11/30/1992	FL	42.0	42		M	11/17/1992	pt vax'd @ 1130AM, @ 830PM became nausea, rt arm painful, swollen, hot by 10PM t101, chills, body aches (joints); 11NOV t100 felt flu-like ate & drank alright; red (1 side) band around rt arm @ site of inject; 12NOV sore throat; sl cough;									U	11/10/1992	11/10/1992	0	NONE	OTH	PUB	Excedrin, Vicks	bronchitis in OCT92	NKA, quit smoking 3-4 yrs ago; scarring of lungs w/fungus;	NONE~ ()~~~In patient		1						1	Arthralgia; Cough; Influenza; Injection site hypersensitivity; Injection site oedema; Myalgia; Pharyngitis; Pyrexia	FLU3~PARKE-DAVIS~00292P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~312944~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0047563	11/30/1992	FL	39.0	39		F	11/18/1992	rt arm where Td given became sore & swollen in 24 hrs; remained for 72 hrs then blistered around site (1-2 diam); pain down arm; swollen from 2 above elbow to shoulder, red, hot blisters white & yellow; swelling moved to joint & muscle;									N	11/10/1992	11/11/1992	1	NONE	OTH	PUB	NONE	NONE	allergic to PCN & Codeine	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Injection site reaction; Oedema; Osteoarthritis; Skin discolouration; Vasodilatation	FLU3~PARKE-DAVIS~00292P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~CONNAUGHT LABORATORIES~2D41070~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0047564	11/30/1992	FL	66.0	66		F	11/18/1992	devel soreness w/in 1 hr of receiving flu & pneumovax in rt arm; 24 hrs later t101, lethargic; slept; nauseated missed 1 days work, lt next day early; t101; local reaction sl redness, no swelling;									Y	11/10/1992	11/11/1992	1	NONE	OTH	PUB	HCTA, Synthroid, Micro K	NONE	NKA, controlled hypertension, hypothyroid	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Myalgia; Nausea; Pyrexia; Somnolence	FLU3~PARKE-DAVIS~00292P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~UNKNOWN MANUFACTURER~~1~~LA~PNEUMO (NO BRAND NAME)~1|TD~CONNAUGHT LABORATORIES~2D41070~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0047565	11/30/1992	FL	44.0	44		F	11/19/1992	painful inject @ time, burned cont to hurt; rt arm immobilized, chills or hot, h/a, aching all over, 11NOV rt arm began to swell, red lines around upper arm w/center area of reddened, induration; widened to 2 band around upper arm (hot); ;									N	11/10/1992	11/10/1992	0	NONE	OTH	PUB	Estrogen	NONE	NKA	NONE~ ()~~~In patient		1						1	Headache; Hypokinesia; Injection site hypersensitivity; Injection site mass; Injection site pain; Myalgia; Oedema; Skin striae	FLU3~PARKE-DAVIS~002P2P~2~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~312914~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0047566	11/30/1992	FL	55.0	55		F	11/18/1992	pt recvd flu & pneumovax 2PM 10NOV by 11NOV t101, ached all over, lt arm painful, difficult to move, erythema shoulder to elbow; stayed home in bed; 12NOV very tired, temp up to 101 by evening, diaphoretic; by noon tired, h/a in bed for 24;									Y	11/10/1992	11/11/1992	1	NONE	OTH	PUB	PPD; Mezacor, HCTZ, allergy shots, ASA	NONE	Mitral valve detect, allergic to pollen, arthritis, mold	pt exp joint pain @ 45 w/Heptavax 1, 2, 3, 4;~ ()~~~In patient		1						1	Asthenia; Headache; Hyperhidrosis; Hypokinesia; Injection site hypersensitivity; Myalgia; Pain; Pyrexia	FLU3~PARKE-DAVIS~00292P~4~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~512944~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0047568	11/30/1992	WI	62.0	62		F	11/18/1992	sudden onset of spinning vertigo accompanied by nausea; no other sx; vertigo lasted 5 minutes; pt had to sit down p/episode pt returned to nl; pt called MD who had treated labyrinthitis & was given Meclazine for dizziness for labyrinthitis;									Y	11/09/1992	11/10/1992	1	NA	OTH	PVT	Vasotec, Hydrochorothiazide	NONE	labyrinthitis dx SEP92	~ ()~~~In patient		1						1	Condition aggravated; Dizziness; Nausea; Vertigo	FLU3~LEDERLE LABORATORIES~337907~1~SC~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0047569	11/30/1992	WI	53.0	53		F	10/19/1992	sore throat, huge glands 52 hrs p/shot; temp started Friday, up to 102; sinus problems, ears clogged up; minimal gastric disorder; coughing some;									U	10/14/1992	10/16/1992	2	NONE	PUB	PUB		NONE	NONE	~ ()~~~In patient		1						1	Cough; Ear disorder; Gastrointestinal disorder; Lymphadenopathy; Pharyngitis; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~00882P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0047570	12/01/1992	FL	37.0	37		F	11/16/1992	13NOV92 pt recvd vax & devel chest pains, tightness of chest, SOB, lt arm began to get hard, red & difficult to move; became weak, lethargic, tightness in joints, hands aching; became agitated; also rapid pulse & air hunger;				Y					N	11/13/1992	11/13/1992	0	NONE	PUB	PUB	NONE	NONE	prolapses mitral valve	NONE~ ()~~~In patient	FL92066	1						1	Arthropathy; Asthenia; Chest pain; Dyspnoea; Hypokinesia; Myalgia; Somnolence; Tachycardia	FLU3~PARKE-DAVIS~01272P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0047571	12/02/1992	MA				U	11/13/1992	pt recvd flu vax & devel cellulitis @ the site of inject; pt was hosptialized 4 day & treated w/ATB;					Y	4			Y					OTH	OTH		AIDS	pat has AIDS	~ ()~~~In patient	892323002E	1						1	Cellulitis	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0047572	12/02/1992	MA				U	11/13/1992	pt recvd flu vax & pt devel cellulitis @ the site of inject; pt was hospitalized 4 days & treated w/ATB;					Y	4			Y					OTH	OTH				~ ()~~~In patient	892323001E	1						1	Cellulitis; Injection site reaction	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0047573	12/02/1992	CA	68.0	68		M	10/16/1992	pt recvd flu vax 12OCT92 & during dialysis tx on 14OCT92 devel sudden onset of chills & fever 102 p/ 1 hr treatment; also had clotted graft; exp exacerbation of herpes simplex;					Y	6			Y	10/12/1992	10/14/1992	2	cultures were neg; pyrogen test on dialysate was w/in acceptable limits;	PVT	PVT	various (info not provided)	ERSD	pt has chronic renal fialure, thalassemia, arteriosclerotic kidney disease, & is allergic to PCN;	~ ()~~~In patient	892293003E	1						1	Chills; Coagulopathy; Condition aggravated; Pyrexia	FLUX~PFIZER\WYETH~4928234~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0047578	12/02/1992	MO	81.0	81		F	11/30/1992	pt recvd vax 12NOV92 & on 13NOV92 c/o pain in legs; 16NOV92 devel congestion & cough; denies fever; did not consult MD;									Y	11/12/1992	11/13/1992	1	NONE	PUB	PUB	Corgard, ASA, Cortisone	NONE	arthritis, Artery problem	NONE~ ()~~~In patient	MO92086	1						1	Cough; Pain; Rhinitis	FLUX~PFIZER\WYETH~4928223~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046631	12/03/1992	CA	75.0			F	11/09/1992	pt exp n,d, diaphoresis 1 1/2 hrs p/flu vax; pt was adm to hosp & d/c the following day; Phenergan given for n,v;					Y	1			U	10/27/1992	10/27/1992	0		PUB	OTH	Lanoxin, Vasotec, Mellaril, Premarin, Tegretol, Prilosec, Prozac, urecholine, Carafate;		pt has hx of cardiac dysrhythmia, asthma, peripheral neuritis secondary to shingles, anemia, esophageal strictures, peptic ulcer disease; allergies include codeine, pred, morphine (in large amounts), Compazine, Talwin, Brethine, Isordil,	~ ()~~~In patient	892325002E	1						2	Hyperhidrosis; Nausea; Vomiting; Hyperhidrosis; Nausea; Vomiting	FLUX~PFIZER\WYETH~4928234~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928234~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0047645	12/03/1992	CT	62.0	62		F	11/20/1992	pt recvd flu vax on 27OCT92; On 11NOV92 presented to MD w/ c/o h/a, back pain, arm numbness & disequilibirum; pt was hospitalized; pt dx GBS on 13NOV92;			Y		Y				U	10/27/1992	11/09/1992	13		PVT	OTH		NONE		~ ()~~~In patient	892325003E	1						1	Back pain; CSF test abnormal; Coordination abnormal; Facial palsy; Guillain-Barre syndrome; Headache; Paraesthesia; Quadriplegia	FLUX~PFIZER\WYETH~4928214~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0047646	12/03/1992	MN	38.0	38		M	11/20/1992	Pt recvd flu vax on 13NOV92; 15NOV92 exp pruritus, welts all over the body, red ears, diarrhea, vomiting, & bloating; adm to hosp; pt was found to have an elevated white blood cell count; 23NOV92 pt is recovering;				Y	Y	3			U	11/13/1992	11/16/1992	3		OTH	OTH	UNK	UNK	pt has hx of histoplasmosis	~ ()~~~In patient	892328002E	1						1	Diarrhoea; Gastroenteritis; Generalised oedema; Leukocytosis; Pruritus; Urticaria; Vasodilatation; Vomiting	FLUX~PFIZER\WYETH~4928132~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0047648	12/03/1992	AZ	36.0	36		F	11/16/1992	swollen rt arm up to side of rt breast; couldn't lift arm; redness down entire arm x3 days; 4 days later mobility returned to upper arm, swelling decreased; muscle in arm stiff, rigid & arm weak; swelling occurs in rt hand w/overuse of arm;									N	10/29/1992	10/29/1992	0		PUB	PUB	Ansaid	pt denies chronic sinus problems	on pred 6 mos prior/dx lumbar disc disease/duodual ulcer	pt exp allergic rxn @ 21 w/Td booster~ ()~~~In patient	AZ9229	1						1	Hypertonia; Hypokinesia; Myasthenic syndrome; Oedema; Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~2F31112~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~322926~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0047649	12/03/1992	AZ	70.0	70		M	11/11/1992	pt arm became sore also shoulder & neck 9OCT PM felt had temp did not take ?100; 11NOV92 seen by MD CXR done; inflamed lt side chest; eratic heart, inc BP;									Y	11/07/1992	11/09/1992	2	CXR, EKG, various blood tests;	PUB	PUB	ATB	pt denies	heart disease-lung disease-pt is on 02	~ ()~~~In patient	AZ9230	1						1	Chest pain; Hypertension; Myalgia; Neck pain; Pyrexia	FLU3~PARKE-DAVIS~01872P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0047651	12/03/1992	CT	74.0	73		M	11/13/1992	ill w/flu shot; went to MD & treated for URI- thought it was flu shot; treated w/ATB terrible sore throat; 10NOV-23NOV;				Y					Y	10/29/1992	11/10/1992	12	NONE	PUB	PVT	NONE	NONE	rheumatic heart disorder	NONE~ ()~~~In patient	ME92023	1						1	Malaise; Pharyngitis	FLU3~PARKE-DAVIS~00682P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0047652	12/03/1992	ME	40.0	40		M	11/19/1992	went to MD 18NOV; sore throat 15NOV progressive; very red, inflammed throat;  poss strep, cultured not strep; viral infect;				Y					N	11/10/1992	11/15/1992	5	culture for strep neg;	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	ME92029	1						1	Infection; Pharyngitis	FLUX~PFIZER\WYETH~4928115~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047665	12/03/1992	MS	41.0	41		F	10/16/1992	14OCT92 approx 11PM woke up having difficulty breathing; noticed red rash on neck p/2nd episode of SOB; worked 15OCT92; rash worsened took DPH & applied Hydrocortisone cream; late 15OCT92 PM to ER w/severe red raised rash, difficulty breath					Y				N	10/14/1992	10/14/1992	0	Thyroid function study, UA, SMAC, Stool, Cholesterol	PUB	PUB	NONE	NONE	NONE- hi cholesterol	NA~ ()~~~In patient	MS9253	1						1	Dermatitis bullous; Dyspnoea; Hypertension; Rash; Rash maculo-papular	FLUX~PFIZER\WYETH~42928149~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0047666	12/03/1992	MS	41.0	41		M	10/28/1992	26OCT92 @ approx 1AM awaken w/upset stomach, h/a, weak, sick feeling, achy, temp lasted x 24 hrs;									Y	10/22/1992	10/26/1992	4		PUB	UNK		NONE	NONE	NONE~ ()~~~In patient	MS9254	1						1	Asthenia; Dyspepsia; Headache; Malaise; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~4928149~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047667	12/03/1992	MS	81.0	81		F	10/26/1992	red, swollen, painful rt arm @ site of inject; felt very weak; unable to get back into bed; went to hosp 1030-11 Thurs AM; admitted; poss also had UTI;					Y				N	10/21/1992	10/21/1992	0		PUB	PUB	BP med-Dinosur? spell	NONE does have BP problem	allergic to Morphine-diverticulosis; hx light stroke;	~ ()~~~In patient	MS9255	1						1	Asthenia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Urinary tract infection	FLUX~PFIZER\WYETH~4928149~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~308911~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0047668	12/03/1992	MS	70.0	70		F	10/26/1992	pt had massive coronary & died on 21OCT92;	Y	10/21/1992							N	10/09/1992	10/21/1992	12	NONE	PUB	PUB	NONE	NONE	NONE	NA~ ()~~~In patient	MS9256	1						1	Cardiac arrest	FLUX~PFIZER\WYETH~4928202~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~308913~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Results in Death	Influenza
0047669	12/03/1992	MS	72.0	72		F	10/30/1992	pt called the clinic today stating that devel sx of dizziness, h/a, & nausea the same day the flu vax was administered & continues to have these sx; 2NOV92 seen by clinic- rxn to flu vax vs episode of viral gastroenteritis; systolic hyperte									Y	10/09/1992	10/09/1992	0	NONE	PUB	PUB		NA	NA	~ ()~~~In patient	MS9257	1						1	Dizziness; Gastroenteritis; Headache; Hypertension; Infection; Nausea	FLUX~PFIZER\WYETH~4928149~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047670	12/03/1992	MS	59.0	59		F	11/13/1992	c/o itching & allergic rash on rt arm day following vax then itching in both arms; no fever or other sx; Rx w/vit E ointment;									N	10/19/1992	10/19/1992	0		PUB	PUB	vitamins, Homonal	NONE	back surgery 1967-76; allergic to sulfa, APAP #3	~ ()~~~In patient	MS9258	1						1	Hypersensitivity; Pruritus; Rash	FLUX~PFIZER\WYETH~4928149~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047685	12/04/1992	CT	35.0	35		M	11/24/1992	Started w/paresthesia in arms a few hrs p/inject; Progressed to generalized weakness; adm to hosp to neuro intensive care w/partial paralysis of all extremities; never required resp assistance; plasmaphorisis done;					Y	29			N	11/11/1992	11/11/1992	0		UNK	UNK	NONE		NONE	~ ()~~~In patient	CO4553	1						1	Asthenia; Dysphagia; Guillain-Barre syndrome; Hepatic function abnormal; Hypertonia; Paraesthesia; Quadriplegia; Asthenia; CSF test abnormal; Guillain-Barre syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~2F31098~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~2F31098~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0047697	12/04/1992	TN	57.0	57		F	10/30/1992	5 days p/vax began having rash all over body-burning sensation w/rash; rash raised papules primarily on trunk; severe itching rash cont x 2 wks;				Y					Y	10/07/1992	10/13/1992	6		PUB	PUB	Flagyl	NONE	vagnitis	~ ()~~~In patient	TN92156	1						1	Pain; Pruritus; Rash; Rash maculo-papular	FLUX~PFIZER\WYETH~4928232~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047701	12/04/1992	TN	41.0	41		M	11/17/1992	bilateral ear infection, bronchitis				Y						11/06/1992	11/07/1992	1		PUB	PUB				~ ()~~~In patient	TN92160	1						1	Bronchitis; Otitis media	FLUX~PFIZER\WYETH~4928233~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047705	12/04/1992	TX	69.0	69		M	11/06/1992	8 days later tightness in back between shoulder blades;									Y	10/27/1992	11/03/1992	7	seen by MD given muscle relaxant;	PUB	PUB		NONE		NONE~ ()~~~In patient	TX92221	1						1	Hypertonia	FLUX~PFIZER\WYETH~4928285~3~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047706	12/04/1992	TX	63.0	63		F		no strength in lt arm & lt leg; starting 5NOV92 afternoon; went to local ER @ 330- 6NOV92; was given Ibuprophen;				Y					U	11/05/1992	11/05/1992	0		PUB	PUB	Trental; APAP	NONE	arthritis, ulcer, Internal varicose veins	~ ()~~~In patient	TX92222	1						1	Myasthenic syndrome	FLUX~PFIZER\WYETH~4928207~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~CONNAUGHT LABORATORIES~1K31145~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047714	12/04/1992	TX	73.0	73		F	11/06/1992	Whelps to lt forearm; 2-3cm in size; states noticed them last noc when got up to use bathroom; denies itching; adviced to go to Pharm & buy DPH;									Y	11/04/1992	11/05/1992	1		PUB	OTH		NONE	BP med; med for diabetes	~ ()~~~In patient	TX92231	1						1	Urticaria	FLUX~PFIZER\WYETH~4928285~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047716	12/04/1992	TX	63.0	63		F	11/18/1992	aching, h/a, n,v, fever, chills since 3NOV92; 20NOV feeling 100% better;									Y	11/02/1992	11/03/1992	1		PUB	UNK	No meds			~ ()~~~In patient	TX92233	1						1	Chills; Headache; Myalgia; Nausea; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~01082P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~UNKNOWN MANUFACTURER~336942~UNK~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0047717	12/04/1992	TX	65.0	65		F	11/16/1992	pt stated shot was very painful; pt was instructed to massage the arm & take APAP for discomfort;				Y					U	11/09/1992	11/09/1992	0	x-ray;	PUB	PUB		BP	BP	~ ()~~~In patient	TX92234	1						1	Injection site pain	FLUX~PFIZER\WYETH~4928207~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047719	12/04/1992	TX	1.3	1	.3	M	11/20/1992	pt recvd flu/MMR vax & returned following morning had wheals on abdomen, rt shoulder, rt thigh & lt inner thigh; mom noticed morning of 5NOV92; MD dx urticaria;				Y					Y	11/04/1992	11/05/1992	1	NONE	PUB	PUB	Amoxcil; cough medicine	upper respiratory infection	Bil OM	~ ()~~~In patient	TX92236	1						1	Urticaria	FLU3~LEDERLE LABORATORIES~337905~1~IM~LL~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|MMR~MERCK & CO. INC.~06682~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0047720	12/04/1992	TX	86.0	86		F	11/23/1992	shot administered 20NOV92 by 21NOV92 pt was nauseated, had vomiting; 23NOV92 pt advised to see pvt MD if sx persist to r/o vax rxn;									U	11/20/1992	11/21/1992	1		PUB	PUB	UNK	NONE		~ ()~~~In patient	TX92237	1						1	Nausea; Vomiting	FLUX~PFIZER\WYETH~4928241~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~336942~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0047722	12/04/1992	WA	75.0	75		M	10/30/1992	fever, chills, confusion, arthralgia-rx'd w/APAP;									Y	10/27/1992	10/28/1992	1	NONE	PVT	UNK				~ ()~~~In patient	WA92785	1						1	Arthralgia; Chills; Confusional state; Pyrexia	FLU3~PARKE-DAVIS~00982P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0047725	12/04/1992	WA	56.0	56		F	11/05/1992	8hrs post vax had mass bruises all over back of leg-gave Pred & APAP; 3NOV Restoril; 4NOV lorazepam;			Y						N	10/26/1992	10/26/1992	0	idiopathic Thrombocytopenic purpura;	PUB	PVT	NA	NA	allergies to various weeds;	~ ()~~~In patient	WA92788	1						1	Ecchymosis; Thrombocytopenic purpura	FLUX~PFIZER\WYETH~49228231~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~304904~1~~LA~PNEUMO (PNU-IMUNE)~1	USA	Life Threatening	Influenza
0047727	12/04/1992	WA	30.0	30		F	11/02/1992	became feverish 30OCT92; achy; awoke w/sore throat, stuffy nose, h/a, upper back pain, pt could not move neck;				Y					N	10/30/1992	10/30/1992	0		PUB	PVT	NONE	NONE	Fibro cystic tumor-lt breast	NONE~ ()~~~In patient	WA92790	1						1	Back pain; Headache; Hypokinesia; Myalgia; Neck pain; Pharyngitis; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~4928285~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047730	12/04/1992	WA	78.0	78		F	10/30/1992	pt phoned 30OCT92 w/c/o erythema & edema 3 x 8 lt arm just distal of where Td was administered on 28OCT92; pt c/o itching x 24 hrs & mild h/a 30OCT92;									U	10/28/1992	10/29/1992	1	NA	PUB	PUB	Premarin, Amityyptiline, Ectrin	NONE	NKOA, Epidural in AUG92;	NONE~ ()~~~In patient	WA92793	1						1	Headache; Injection site hypersensitivity; Injection site oedema; Pruritus	FLUX~PFIZER\WYETH~4928285~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~LEDERLE LABORATORIES~318900~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0047731	12/04/1992	WA	67.0	67		F	11/10/1992	describes soreness in lt arm for 2 days p/shot; then 5 days later was unable to move lt hand or use it to pick up object; strength has slowly been returning but not yet nl; soreness in lt arm persists; referred to MD;									U	10/28/1992	11/02/1992	5	NA	PUB	PUB		NONE		~ ()~~~In patient	WA92794	1						1	Hypokinesia; Myalgia; Myasthenic syndrome	FLUX~PFIZER\WYETH~4928231~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047732	12/04/1992	WA	60.0	60		M	11/09/1992	beginning 6NOV92 felt dizzy, lightheaded, listless, didn't want to do anything; late 7NOV92 began to have diarrhea; no cramping still having diarrhea; still weak 16NOV92;									Y	11/05/1992	11/06/1992	1		PUB	PUB				~ ()~~~In patient	WA92795	1						1	Asthenia; Diarrhoea; Dizziness; Malaise	FLUX~PFIZER\WYETH~4928109~3~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047734	12/04/1992	WA	59.0	59		M	11/17/1992	pt recvd vax 13OCT92; 25OCT92 deel numbness in legs & pain in low back extending down legs; seen by MD dx GBS; devel body wide parasis but not intubated; had 4 total plasma exchange			Y		Y	23			N	10/13/1992	10/25/1992	12		OTH	PVT	NONE	NONE	adult onset diabetic-diet control	~ ()~~~In patient	WA92797	1						1	Back pain; Guillain-Barre syndrome; Paraesthesia; Paralysis; Guillain-Barre syndrome	FLUX~PFIZER\WYETH~4928243~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928243~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation	Influenza
0047737	12/04/1992	WA	42.0	42		F	11/16/1992	6OCT92 woke w/upset stomach & sl dizziness which lasted the day; 19OCT92 legs began to feel weak & achy; this feeling ascended to shoulders then upper extremities & neck legs discomfort deminished; felt feverish shook w/t99.8;				Y					U	10/05/1992	10/06/1992	1		PUB	PVT	NONE	NONE	takes premarin PRN for complete hypterectomy @ 21;	NONE~ ()~~~In patient	WA92800	1						1	Asthenia; Chills; Dizziness; Dyspepsia; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~4928231~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047738	12/04/1992	WA	45.0	45		F	11/12/1992	large warm area w/itching on rt arm @ inject site-onset 3 days p/inject; aching, t99.2 since noc of inject;									N	11/09/1992	11/11/1992	2	NONE	PUB	UNK	Advil	NONE	NONE	NONE~ ()~~~In patient	WA92801	1						1	Myalgia; Pruritus; Pyrexia; Vasodilatation	FLUX~PFIZER\WYETH~4928231~7+~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047739	12/04/1992	WA	34.0	34		F	11/09/1992	no systemic c/o; felt large warm lump @ site of inject red, raised & tender to touch; 3 days later lump & redness measured 2 x 2 1/2 inches; pt states it was much bigger day p/shot;									Y	11/06/1992	11/06/1992	0	NONE	PUB	UNK	Ibuporfen	NONE	chronic headaches, TMJ problem-Ibuprofen	NONE~ ()~~~In patient	WA92802	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLUX~PFIZER\WYETH~4928231~4~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047740	12/04/1992	WA	76.0	76		F	11/20/1992	about a wk p/shot pt has weakness & fever & chills now lasting 3 wks; if pt stays in & resting pt is OK If pt up & active  pt is ill; lasted 3 months MD could find no cause;									U	10/21/1992	10/28/1992	7	NONE	PUB	PUB	Insulin	NONE		pt exp weakness, fever chills @ 75 y/o w/flu vax #1;~ ()~~~In patient	WA92803	1						1	Asthenia; Chills; Pyrexia	FLUX~PFIZER\WYETH~4928205~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047743	12/04/1992	NY	67.0	67		M	11/25/1992	inc confusion, spinal tap w/inc lymphocytes neg cultures; RPR, India ink, cryptococcal antigen, consistent w/encephalitis; also found to have nl pressure hydrocephalus;					Y	15			Y	10/22/1992	10/22/1992	0	spinal tap consistent w/meningoencephalitis;	PVT	UNK		NONE	NONE	~ ()~~~In patient		1						1	CSF test abnormal; Confusional state; Encephalitis; Hydrocephalus	FLU3~CONNAUGHT LABORATORIES~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0047746	12/04/1992	CO	78.0	78		F	11/29/1992	devel cellulitis on arm p/flu vax; resolved w/ATB;				Y					Y	11/04/1992	11/05/1992	1	NA	OTH	PVT	Ethanbotie, Cepro, Ritapin, Albuterol, Pyridoxin;	MTB	NKDA-mycobactera tubeculosis	~ ()~~~In patient		1						1	Cellulitis	FLUX~PFIZER\WYETH~4928224~3~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047747	12/04/1992	MA				U		3-4 wks raised rash chest, neck & waistline area; No itch associated w/this rash; tx w/mild antihistamine;									Y	10/05/1992	10/05/1992	0	CBC/diff-WNL	PVT	PVT	Premarin	NO		~ ()~~~In patient		1						1	Rash	FLU3~CONNAUGHT LABORATORIES~~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0047749	12/04/1992	CA	43.0	43		M	11/30/1992	sudden onset h/a then in 4 hrs myalgia/arthralgia & diplopia w/in an hr; shortly p/fever 103-104 & shaking chills; same clavicular & costal margin pain w/deep inspiration; shaking chills, h/a, diplopia suddenly stopped p/16 hrs;									Y	11/05/1992	11/08/1992	3	serology pending;	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	CA92147	1						1	Arthralgia; Chills; Diplopia; Headache; Myalgia; Pain; Pyrexia	FLUX~PFIZER\WYETH~4928225~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~MERCK & CO. INC.~0965T~3~A~~HEP B (RECOMBIVAX HB)~1	USA		Influenza
0047752	12/04/1992	MA	74.0	74		M	11/20/1992	Took flu shots 23OCT92; 3 days later started cold sx & then turned into severe chest cold; was congested for 4 to 6 wks; no fever; little if any aching joints;									Y	10/23/1992	10/26/1992	3		OTH	PUB	Lanoxin, Enderal, ASA	NONE	heart disease	NONE~ ()~~~In patient		1						1	Arthralgia; Deafness; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047138	12/07/1992	IL	68.0	68		F	12/01/1992	Red, macular, pruritic rash started w/in 24-30 hrs; pt adm to hosp 13 days p/vax w/progressing rash/pruritis; MD feels poss serum sickness or Stevens-Johnson synd;			Y		Y				U	10/12/1992	10/13/1992	1	WBC 18,000 w/17% Eosinophiles;	UNK	UNK			allergy to eggs;	~ ()~~~In patient	CO4560	1						2	Dermatitis bullous; Pruritus; Serum sickness; Stevens-Johnson syndrome; Eosinophilia; Leukocytosis; Pruritus; Rash maculo-papular; Serum sickness; Stevens-Johnson syndrome	FLU3~CONNAUGHT LABORATORIES~2F31132~7+~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~2F31132~7+~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0047685	12/07/1992	CT	35.0	35		M	11/24/1992	12NOV92 paresthesia upper lt extremities; 13NOV92 paresthesia lower extremities; 14NOV92 weakness in arms/hand; 15NOV92 weakness in lower extremities; 16NOV92 MD visit;			Y	Y	Y				U	11/11/1992	11/12/1992	1	elevated protein in CSF; nerve conduction testing consistent w/early GBS;	OTH	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						2	Asthenia; Dysphagia; Guillain-Barre syndrome; Hepatic function abnormal; Hypertonia; Paraesthesia; Quadriplegia; Asthenia; CSF test abnormal; Guillain-Barre syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~2F31098~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~2F31098~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0047753	12/07/1992	NJ	60.0	59		M	11/19/1992	pt adm to hosp 14NOV92 due to pancytopenia & sepsis; pt was thought to have recvd flu vax prior to this event; Ceftazidime therapy was inititated; Bone marrow biopsy is planned;			Y		Y				U	11/01/1992	11/14/1992	13		OTH	OTH	Theo-dur, Epogen, Ferrous Sulfate	UNK	pt has hx of chronic renal failure;	~ ()~~~In patient	892328001E	1						1	Aplastic anaemia; Chills; Infection; Leukopenia; Myalgia; Pancytopenia; Pyrexia; Thrombocytopenia	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0047755	12/07/1992		53.0	53		U	12/01/1992	Guillain Barre; started w/weakness on rt leg & spread to lt leg; adm to hosp on 30OCT92 & is still hospitalized;			Y		Y				N	10/08/1992	10/26/1992	18		UNK	UNK				~ ()~~~In patient	CO4555	1						1	Asthenia; Guillain-Barre syndrome; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0047760	12/07/1992	CA	76.0	76		F	12/05/1992	pt recvd flu vax on 14OCT91 & 2 wks later (about the end of OCtober) pt devel a fever of unk origin accompanied by myalgias, joint swelling & neck stiffness; pt was hospitalized & had an extensive workup w/neg temporal artery biopsy;				Y	Y				N	10/14/1991	10/28/1991	14	High sed rate; dx polymyalgia rheumatica;	PVT	PVT	NONE	NONE	pt has a hx of discoid lupus, tuberculous pericarditis, & hypothyroidism;	~ ()~~~In patient	892314006K	1						1	Myalgia; Nuchal rigidity; Osteoarthritis; Pyrexia	FLUX~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0047765	12/07/1992	ID	24.0	24		F	11/19/1992	2 lumps under lt arm then next day 1 lump under rt arm; reddness also noted on lumps; lumps came & reduce & then inc in size over approx 2 wks time;				Y					Y	10/26/1992	10/28/1992	2		PUB	PUB	NONE	NONE	PCn-parafin forte	~ ()~~~In patient	ID92074	1						1	Lymphadenopathy; Vasodilatation	FLUX~PFIZER\WYETH~4928231~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047766	12/07/1992	ID	57.0	57		F	11/19/1992	numbness lt index finger & thumb; lasted approx 8 hrs; forearm lt felt strained & unusual;									Y	10/29/1992	11/12/1992	14	NA	PUB	PUB	NONE			~ ()~~~In patient	ID92075	1						1	Paraesthesia	FLUX~PFIZER\WYETH~4928231~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047767	12/07/1992	ID	70.0	69		M	11/09/1992	evening of 26OCT92 exp burning & itching sensation all over; next AM awakened w/red raised rash all over body; some rash remaining 9NOV92;									Y	10/26/1992	10/26/1992	0	NONE	PVT	UNK	Prenivil, Zyloprim	NONE	hypertension-allergy to mercurochrome	NONE~ ()~~~In patient	ID92076	1						1	Pain; Pruritus; Rash maculo-papular	FLU3~LEDERLE LABORATORIES~338972~3~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0047772	12/07/1992	LA	74.0	74		F	11/09/1992	c/o pain & swelling in lt deltoid region; started in PM of same day follwoing vax given 4NOV92; still c/o pain in upper arm & does not have complete use;									Y	11/04/1992	11/04/1992	0	NONE	PUB	PUB	NONE	NONE	had breast surgery JAN92, lymph nodes removed;	NONE~ ()~~~In patient	LA921203	1						1	Hypokinesia; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~4928285~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047775	12/07/1992	ME	55.0	55		M	12/01/1992	went to MD 25NOV what pt had did not seem to be related to vax; cough, sore throat @ onset 23NOV92; cough, no fever noted; had back pain a/& was out w/that; stayed home during sickness; better now, but not over it;				Y					N	11/02/1992	11/23/1992	21	NONE	PUB	PVT	Cardisome co/Trimmterine, Hydroxidine, Lopid, Amoxycillin; pt recvd Hep B vax by SKB lot# 1048A4;	NONE	allergic ASA, Anapro, ctiric acid-many fruits; 5 way bypass-coronary H.D.; no birth defects	unk~ ()~~~In patient	ME92030	1						1	Back pain; Cough; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~01972P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0047779	12/07/1992	MD	79.0	79		M	11/02/1992	pt exp nausea & vomiting & generalized rash, worse on soles of feet & palms of hands, w/severe itching, approximately 36 hrs p/vax; These sx resolved 24-36 hrs later;									Y	10/27/1992	10/29/1992	2	NONE	PUB	PUB	UNK	NONE	NONE	~ ()~~~In patient	MD92080	1						1	Nausea; Pruritus; Rash; Vomiting	FLUX~PFIZER\WYETH~4928283~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~308911~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0047781	12/07/1992	MD	72.0	72		F	11/04/1992	pain in rt arm also shoulder & neck limited use-unable to lift above eye level; rx w/Cephalexin, Codeine, ASA;				Y					N	11/02/1992	11/02/1992	0	NONE	PUB	PUB	NONE	NONE	allergic to Cortisone	~ ()~~~In patient	MD92082	1						1	Hypokinesia; Neck pain; Pain	FLU3~CONNAUGHT LABORATORIES~00982P~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~318920~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0047782	12/07/1992	MD	59.0	59		F	11/16/1992	felt malaise immediately p/vax 12NOV92; lt arm @ site of inject swelled-30x40mm-erythema-induration, bruising-16NOV92 area remains red, swollen & itching;									N	11/12/1992	11/12/1992	0		PUB	PUB	Isordic, Procardia XL, Mevacor, Synthroid, ASA, Cortisone shot;		allergic PCN, APAP cold Cap-arthritis-knees, hip, arms-Thyroid dx heart dx-hiatal hernia, inc cholesterol-angina;	~ ()~~~In patient	MD92083	1						1	Ecchymosis; Injection site hypersensitivity; Injection site mass; Injection site oedema; Malaise; Pruritus	FLUX~PFIZER\WYETH~4928243~2~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047783	12/07/1992	MS	47.0	47		F	11/19/1992	Pt had onset of flu sx 3-4 days p/flu vax; chills, h/a, diarrhea, tenderness of forearm; still had s/s 18NOV92 but were dec;									Y	11/04/1992	11/07/1992	3	SM-1 profile; TSH-WNL; Trigly-inc; Cholesterol-228;	PUB	UNK	Synthroid, Mevacor, Vit C		hypothrodism, hyperlipdemia; post menopausal sx;	~ ()~~~In patient	MS9262	1						1	Chills; Diarrhoea; Headache; Influenza; Myalgia	FLUX~PFIZER\WYETH~4928149~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047784	12/07/1992	MS	63.0	63		M	11/24/1992	pt has had production of white sputum since the flu vax was given, 2 wks ago;									Y	10/20/1992	10/20/1992	0	inc total protein (10.0); albumin-WNL;	PUB	UNK	Procardia, Lasix, Lanoxin, Prinivil, Tagamet		HTN, CAD, CHF, Arthritis	~ ()~~~In patient	MS9263	1						1	Laboratory test abnormal; Productive cough	FLUX~PFIZER\WYETH~4928149~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047787	12/07/1992	NH	24.0	24		F	10/30/1992	1/2 hrs p/having shot diarrhea & h/a, fatigue, hot flashes, nausea, stomach bloated;									Y	10/26/1992	10/28/1992	2		PUB	PUB				~ ()~~~In patient	NH92017	1						1	Asthenia; Diarrhoea; Flatulence; Headache; Nausea; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~2F31109~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0047788	12/07/1992	NH	33.0	33		F	10/30/1992	red non-tender, non-puritic, hot to touch; large arm, inject administered @ lower border of muscle insertion; no tx;				Y					Y	10/26/1992	10/28/1992	2		PUB	PUB		NONE	NONE	~ ()~~~In patient	NH92016	1						1	Oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~2F31109~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0047807	12/07/1992	SC	53.0	52		F	10/27/1992	about 6PM pts throat began to swell; called MD & was advised to take DPH; swelling subsided;									Y	10/20/1992	10/20/1992	0		PUB	UNK			allergic pain medicines & tranquiliers;	NONE~ ()~~~In patient	SC92138	1						1	Laryngospasm	FLU3~CONNAUGHT LABORATORIES~2F31171~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0047808	12/07/1992	SC	63.0	63		F	11/06/1992	pt states had sudden onset 5NOV92 evening fever (felt hot-did not take temp), chills & difficulty breathing & throat felt hard & stomach felt like it was blowed up; called ask a nurse told to take DPH; 6NOV92 puffy eyes;									Y	11/05/1992	11/05/1992	0		PUB	UNK		NONE		NONE~ ()~~~In patient	SC92139	1						1	Chills; Dyspnoea; Face oedema; Flatulence; Laryngospasm; Pyrexia	FLU3~CONNAUGHT LABORATORIES~2F31171~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0047809	12/07/1992	UT	34.0	34		M	11/17/1992	top of shoulder very sore; unable to raise arm w/o pain site of inject; shows no abnormalities; seen by MD who prescribed Anaprox DS;				Y					N	10/28/1992	10/28/1992	0		OTH	PVT		NONE	NONE	~ ()~~~In patient	UT920430	1						1	Hypokinesia; Injection site pain; Myalgia	FLUX~PFIZER\WYETH~4928229~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047813	12/07/1992	CT	61.0	61		M	11/25/1992	had flu shot 27OCT92 had difficulty walking & facial paralysis on 16NOV & was hospitalized; initial dx GBS;					Y				U	10/27/1992	11/16/1992	20	UNK	PUB	PUB	UNK	NONE	NONE	~ ()~~~In patient		1						1	Facial palsy; Gait disturbance; Guillain-Barre syndrome; CSF test abnormal; Facial palsy; Guillain-Barre syndrome; Hypokinesia; Hyporeflexia; Myasthenic syndrome; Neuropathy; Paraesthesia	FLUX~PFIZER\WYETH~4928149~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928149~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0047815	12/07/1992	CA	55.0	55		F	11/26/1992	CN VII paralysis/peripheral paraesthesia & weakness 2 1/2wks p/inject preceded by 2-3 day back pain; dx GBS; inc CSF protein, hospitalized;					Y	5			N	10/30/1992	11/17/1992	18	CSF Protein-150;	PVT	PVT	NONE	NONE	NONE	UNK~ ()~~~In patient		1						1	Asthenia; Back pain; CSF test abnormal; Guillain-Barre syndrome; Paraesthesia; Paralysis	FLU3~CONNAUGHT LABORATORIES~2F1118~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0047816	12/07/1992	PA	53.0	53		M	11/30/1992	tingling finger & toes, ascending paralysis, quadriplegia, areflexia; Began 2 wks p/flu vax, progressed for 2 wks now recovering; dx GBS;			Y	Y	Y	27			Y	10/15/1992	11/01/1992	17	nerve conduction study-slowing, conduction block-spinal fluid protein 67;	PVT	PVT	Erythromiacin, Drixoral		Non-Hodgkin Lymphoma	NONE~ ()~~~In patient		1						1	Electrocardiogram abnormal; Guillain-Barre syndrome; Hyporeflexia; Paraesthesia; Paralysis; Paralysis flaccid; Quadriplegia	FLUX~PFIZER\WYETH~4928130~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0047822	12/07/1992	MN	21.0	21		F	11/23/1992	@ 2PM on 23NOV92 pt was awakened by lt arm pain in the armpit & lymph node area; was also nauseated & SOB given Toradel IM & APAP;				Y					Y	11/20/1992	11/23/1992	3	NONE	PUB	PVT	NONE	sl cold/sore throat	NONE	~ ()~~~In patient		1						1	Dyspnoea; Nausea; Pain	FLU3~PARKE-DAVIS~00192P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0047823	12/07/1992	WI	81.0	81		F	11/17/1992	flu shot 26OCT-27OCT felt lousey 28OCT & 29OCT went off of food & drink because no appeitie-dehydrated & went to clinic 29OCT & then 30OCT-ER; fever & chills-electrolytes; fever & chills through 10NOV;				Y					Y	10/26/1992	10/27/1992	1		PUB	PUB	Mazide, Auinaglude, Lanoxin	NONE	atrial fib	~ ()~~~In patient		1						1	Anorexia; Chills; Dehydration; Malaise; Pyrexia	FLUX~PFIZER\WYETH~4928232~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047826	12/07/1992	NE	51.0	51		F	12/01/1992	upper resp problems, h/a, chills, pain, swollen joints, hands hurt, kuckles swollen, fluid drained from lt knee by MD, chest pains; had PT-used crutches & finally had to use a wheel chair;				Y					Y	10/20/1992	10/22/1992	2	rheumatoid arthritis 2x aspiration/inject large joints (elbows, knee, shoulders)	UNK	PVT		NONE	NONE	pt exp flu sx @ 49y/o w/flu vax 1/2cc;~ ()~~~In patient		1						1	Chest pain; Chills; Headache; Hypokinesia; Osteoarthritis; Pain; Pharyngitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047827	12/07/1992	PA	27.0	27		M	11/30/1992	numbness in lips, BP 160/92, P110, rash, urticaria, SOB, dysphagia;				Y					Y	10/15/1992	10/15/1992	0	EPI, Zantac, DPH;	PVT	UNK		NONE	NKDA	UNK~ ()~~~In patient		1						1	Dysphagia; Dyspnoea; Hypertension; Paraesthesia; Rash; Tachycardia; Urticaria	FLUX~PFIZER\WYETH~4928146~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047830	12/07/1992	FL				F	11/19/1992	rt deltoid present w/swelling, 1+ warm to touch w/reddness; pt c/o pain to area; no fever present; instructed to use warm compress to area & APAP;									Y				NONE	OTH	PVT		NONE	NKA	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLUX~PFIZER\WYETH~4928285~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~328905~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0047832	12/07/1992	FL	59.0	59		M	11/19/1992	pt came in on 18NOV recvd vax & on 19NOV92 rt deltoid swollen & warm to touch; no fever-told to use warm compress to area & use APAP; MD advised to return if worsens or go to ER;									Y	11/18/1992	11/19/1992	1	NONE	OTH	PVT	DT Connaught lot # 1F31058; given 15OCT92;	NONE	NKA CVA AUG92	~ ()~~~In patient		1						1	Injection site oedema; Vasodilatation	FLUX~PFIZER\WYETH~4928285~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~328905~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0047848	12/08/1992	MO	84.0	84		F	11/27/1992	sore throat, sl hoarse, t99.6; 4NOV92 230PM, t100 c/o being tired, coughing, sore throat; 7NOV started ATB @ 8PM; afebrile & feeling better 12NOV92; ATB finished 14NOV92;									Y	11/03/1992	11/04/1992	1	NONE	OTH	OTH	Fioricet PRN, VIt C, Profine, Calcium	NONE	anxiety, Osteoporosis, DJD	UNK~ ()~~~In patient	MO92083	1						1	Asthenia; Cough; Dysphonia; Pharyngitis; Pyrexia	FLU3~PARKE-DAVIS~01772P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0047849	12/08/1992	MO	86.0	86		F	11/27/1992	sore throat, coughing, general discomfort, t99.3 was highest 12NOV92; 9NOV started Hismanal x 7 days; feeling better 24NOV92;									Y	11/03/1992	11/09/1992	6	NONE	OTH	OTH	Xavax, Ismo, B12, Hypotears, NTg, APAP, MOM, Robitussin, O-Plus-HS, Humulin Insulin, Lasix, Nitro patch,  baby ASA, antivert, Metamucil, Voltaren, Premarin cream, Lavoxin	NONE	diabetes	UNK~ ()~~~In patient	MO92084	1						1	Cough; Pain; Pharyngitis; Pyrexia	FLU3~PARKE-DAVIS~01772P~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0047850	12/08/1992	MO	94.0			F	11/17/1992	6NOV c/o sore throat, coughing, tired, highest t100.9, achy all over; 7NOV PCE x 1 wk;									Y	11/04/1992	11/06/1992	2	NONE	OTH	OTH	EC ASA, Theragram, Pericolace, lanoxin, APAP ES, RObitussin, Pred;	NONE	RA, DOD, ASHD	UNK~ ()~~~In patient	MO92085	1						1	Asthenia; Cough; Myalgia; Pharyngitis; Pyrexia	FLU3~PARKE-DAVIS~01772P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0047854	12/08/1992	IL	80.0	79		F	12/01/1992	19NOV92 productive cough, lt sided chest discomfort w/coughing & deep breathing; mod throat congestion, lungs w/rhonci;				Y					Y	11/13/1992	11/19/1992	6		PVT	UNK	Mevacor, Periactin	NONE	smoker, COPD, H	pt exp COPD & dehyrdation 17DEC91  @ 79 y/o w/flu vax #1;~ ()~~~In patient		1						1	Chest pain; Cough; Pharyngitis; Respiratory disorder	FLU3~CONNAUGHT LABORATORIES~2F31132~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0047857	12/09/1992	PA	74.0	74		F	12/07/1992	pt recvd vax & approx 9 hrs following vax pt devel sweating & did not feel well; pts husband suggested ER but pt did not; pt died @ home;	Y	11/05/1992							N	11/05/1992	11/05/1992	0	No relevant data;	OTH	OTH			COPD, end stage; hyperlimpidemia; hypertension	~ ()~~~In patient	WAES92111093	1						1	Cardiovascular disorder; Hyperhidrosis; Hypertrophy; Malaise; Myocardial infarction; Stupor; Condition aggravated	FLU3~LEDERLE LABORATORIES~335914~1~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|PPV~MERCK & CO. INC.~0100V~1~~~PNEUMO (PNEUMOVAX)~1|FLU3~LEDERLE LABORATORIES~335914~1~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~2|PPV~MERCK & CO. INC.~0101V~1~~~PNEUMO (PNEUMOVAX)~2	USA	Results in Death	Influenza
0047867	12/10/1992	CA	59.0	59		M	12/05/1992	GBS noted weakness of leg 17NOV92; admitted 23NOV; remains inpatient;				Y	Y	12			N	11/07/1992	11/17/1992	10	typical nerve conductionn studies, etc;	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Guillain-Barre syndrome; Myasthenic syndrome	FLUX~PFIZER\WYETH~4928225~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0047876	12/11/1992	WI	38.0	38		F	11/23/1992	devel rt sciatic neuralgia severe 25OCT92 hosp eval nl x/pt w/severe pain @ sciatic distribution; rx Analges; resolved sxs in few days;				Y					Y	10/22/1992	10/25/1992	3	back x-rays-nl;	PVT	UNK		NONE		~ ()~~~In patient		1						1	Neuralgia	FLUX~PFIZER\WYETH~4928213~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~318910~1~IM~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0047879	12/11/1992	NY	56.0	56		M	12/08/1992	shoulder upper back shoulder bldes, hands, knees-arthalgia & myalgias; Pred-Naprosyn-APAP#3;									N	10/26/1992	11/02/1992	7	Rheumatoid fact-neg; ESR-26 (0-15), chem 01-WNL-CBC-WNL, x-ray hands wrists-neg;	PVT	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						1	Arthralgia; Myalgia; Red blood cell sedimentation rate increased	FLU3~PARKE-DAVIS~00982P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0047880	12/11/1992	MI	74.0	74		M	11/02/1992	2-3 days p/flu began having skin rash on entire body; skin began peeling & had to be seen by dermatologist; Psoriasis had been under control prev; MD feels flu vax exacerbated condition;									Y	10/19/1992	10/21/1992	2	DEC92 164 Cholesterol; Cholesterol testing due to med & side effects;	PUB	PUB	skin medication	Psoriasis	Psoriasis	~ ()~~~In patient	MI92178	1						1	Condition aggravated; Dermatitis exfoliative; Rash	FLUX~PFIZER\WYETH~4928231~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0047287	12/14/1992	MA	79.0			F		awoke w/leg pain from knees down, next morning 14OCT92; 13OCT92 in PM had chills did not take temp;									Y	10/13/1992	10/14/1992	1	NONE	PUB	PUB		NONE		~ ()~~~In patient	MA9218	1						2	Chills; Headache; Hyperhidrosis; Pain; Somnolence; Chills; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928230~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0048014	12/14/1992	NY	64.0			M		pt recvd flu vax & 3 days later was hospitalized w/chest pain & was found to have pneumonia w/white blood cell count of 15,000cu/mm; pt has coronary artery disease;					Y					12/01/1991	12/01/1991	0	White Blood Cells-15,000;	UNK	UNK	Amiodarone, Furosemide, Captopril, Digitalis		CAD	~ ()~~~In patient	1291018	1						1	Chest pain; Leukocytosis; Pneumonia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0048023	12/14/1992	IL	65.0	65		M	11/30/1992	pt recvd flu vax 11AM on 19NOV92; 24NOV92 blotches appeared on face then spread to neck; blotches were present for 1 wk;									Y	11/19/1992	11/24/1992	5		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	IL92111	1						1	Rash maculo-papular	FLUX~PFIZER\WYETH~4928215~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0048024	12/14/1992	IL	1.3	1	.3	M	11/05/1992	fever 104 R 6PM 30OCT92 dec w/APAP; clear nasal discharge, lung congestion, cough seen by MD 2NOV92 recvd oral ATB;				Y					Y	10/29/1992	10/30/1992	1	NONE	OTH	PUB		NONE	NONE	NONE~ ()~~~In patient	IL92112	1						1	Cough; Lung disorder; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~4292815~1~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048026	12/14/1992	MA	66.0	66		M		24 hrs p/inject pt achy, tired, chills, headache;									Y	10/21/1992	10/22/1992	1	NONE	PUB	PUB		NONE		~ ()~~~In patient	MA9221	1						1	Asthenia; Chills; Headache; Myalgia	FLUX~PFIZER\WYETH~4928230~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0048027	12/14/1992	MA	65.0	64		F	11/18/1992	viral conjunctivitis; used ATB eye drops prescribed but did not help;									Y	10/28/1992	11/04/1992	7		PUB	UNK				~ ()~~~In patient	MA9222	1						1	Conjunctivitis; Infection	FLUX~PFIZER\WYETH~4928230~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0048028	12/14/1992	MA	70.0	70		M		pt mowing lawn, became overexerted, coughing, throwing up; went to ER; kept overnight, released;				Y	Y	1			Y	10/14/1992	10/15/1992	1	EKG, Blood work up, Enzymes, stress test;	PUB	PUB		NONE	heart problems ?bypass	~ ()~~~In patient	MA9223	1						1	Asthenia; Cough; Vomiting	FLUX~PFIZER\WYETH~4928230~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0048029	12/14/1992	MA				F		4 hrs p/inject pt exp rash & itching @ extremities & scalp; no other sx; no allergy to eggs; advised to call MD; h/a x 1 wk;									Y	10/27/1992	10/27/1992	0		PUB	PUB		NONE	asthma	~ ()~~~In patient	MA9224	1						1	Headache; Pruritus; Rash	FLU3~LEDERLE LABORATORIES~4928230~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0048030	12/14/1992	MA	66.0	66		F		pt became achy in joints had shiver, but stated no fever; some sore throat;									Y	10/14/1992	10/17/1992	3	NONE	PUB	PUB		NONE		~ ()~~~In patient	MA9225	1						1	Arthralgia; Chills; Pharyngitis	FLUX~PFIZER\WYETH~4928230~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0048031	12/14/1992	MA	84.0	84		F		next wk from receiving vax pt lifted arm to get dressed, felt sharp pain in site well above inject site; thereafter arm becoming black & blue & swollen;									Y	10/14/1992	10/20/1992	6	NONE	PUB	PUB		NONE	heart problems takes diuretic	~ ()~~~In patient	MA9226	1						1	Ecchymosis; Oedema; Pain	FLUX~PFIZER\WYETH~4928230~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0048033	12/14/1992	MO	69.0	69		F	11/25/1992	pt states lt upper arm began hurting approx 10-12 hrs following vax; contacted MD 17NOV92; recommendation of ice packs to site; & rx for pain; recontacted MD by phone 24NOV92;										11/11/1992	11/11/1992	0		PUB	PUB	Darvocet		arthritis	~ ()~~~In patient	MO92088	1						1	Injection site pain	FLU3~PARKE-DAVIS~01772P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0048034	12/14/1992	MO	70.0	70		M	12/01/1992	pt recvd flu vax on 30OCT92 devel cold sx on 31OCT92 then devel into flu sx; MD  gave ATB; pt reports went to races & sat in the cold the next day p/shot & had to hold a handkerchief to nose all day;									Y	10/30/1992	10/31/1992	1	NONE	PUB	PUB	Zantac/Rolaids	NONE	colon problems, hiatal hernia, bronchitis	~ ()~~~In patient	MO92089	1						1	Influenza; Pharyngitis; Rhinitis	FLU3~PARKE-DAVIS~01772P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0048043	12/14/1992	MN	67.0	67		F	10/20/1992	16OCT devl difficulty breathing & cough productive of clear mucus; afebrile; over weekend, clammy & weak & had cold sweats upon exertion; seen by MD 19OCT cxr dx of bronchial pneumonia, WBC nl treated w/ATB & Robitussin;				Y					N	10/15/1992	10/16/1992	1	WBC nl; CXR-bronchial pneumonia;	PUB	PUB	mild tranquilizer, anti-Cholesterol, Anti-hypertensive	NONE	chronic bronchitis	~ ()~~~In patient	MN92047	1						1	Asthenia; Cough; Dyspnoea; Hyperhidrosis; Pneumonia	FLUX~PFIZER\WYETH~4928226~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048047	12/14/1992	MN	28.0	28		F	12/03/1992	numbness down whole arm, inability to use arm & squeeze hand-started to improve p/3 wks; went to MD & no treatment;				Y					Y	11/03/1992	11/04/1992	1	NONE	PUB	PUB		NONE	NONE	~ ()~~~In patient	MN92051	1						1	Hypokinesia; Paraesthesia	FLUX~PFIZER\WYETH~928213~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~CONNAUGHT LABORATORIES~1C31020~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048049	12/14/1992	NY	84.0	84		F	10/23/1992	loss of consciousness, paralysis;			Y		Y			Y	U	10/22/1992	10/22/1992	0	dx: intracerebral hemorrhage; no evidence seen by MD of hypersensitivity rxn to vax;	PUB	PUB			NONE	NONE~ ()~~~In patient	BA92001	1						1	Cerebral haemorrhage; Paralysis; Syncope	FLUX~PFIZER\WYETH~4928241~6~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0048051	12/14/1992	NJ	33.0			F	12/08/1992	reported numbness in lt arm from inject site down, starting 4NOV; reported on 13NOV persistent sensory problems requiring hosp admission to hosp;					Y	5			Y	11/02/1992	11/04/1992	2	MRI's, spinal tap, bloodwork	PUB	PVT	Tavist, Proventil, Vanceril, Vancenase	NONE	allergic to Kefsol, Erythromycin, codeine, PPD vehicle	unk~ ()~~~In patient		1						1	Paraesthesia	FLU3~LEDERLE LABORATORIES~337909~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation	Influenza
0048057	12/14/1992	FL	72.0	72		F	12/10/1992	approx 4 days p/receiving inject pt called w/ c/o redness & swelling used warm compresses area 3x3cm w/small pustules; tx Keflex;				Y					Y	11/25/1992	11/30/1992	5	NONE	PVT	PVT		NONE	AODM, HTN, osteoarthritis	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site reaction	FLUX~PFIZER\WYETH~4928232~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048059	12/14/1992	CA	67.0	67		M	11/30/1992	16NOV92 seen @ clinic for abscess on arm p/flu shot; pus has also drained; 2cm indurated abscess; Keflex; seen 23NOV92 for recheck-redness almost gone abscess lt arm resolving;				Y					Y	10/22/1992	11/08/1992	17	NONE	PUB	PUB	UNK	NONE	NONE	UNK~ ()~~~In patient	CA92161	1						1	Injection site abscess; Injection site hypersensitivity; Injection site mass	FLUX~PFIZER\WYETH~4928271~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048068	12/14/1992	FL	71.0	71		M	12/09/1992	3 days later had axial aches & pains x 10-12 days which resolved; no other signs or sx; poss adverse rxn;									Y	11/09/1992	11/12/1992	3	CBC, sed rate, chem profile, UA all neg;	PVT	PVT	Tenormin	NONE	NKA	NA~ ()~~~In patient		1						1	Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~2F31171~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0048073	12/14/1992	IA	48.0	48		F	12/08/1992	approx 10 minutes p/inject pt exp lightheadedness & rapid heartrate of 140 per minute; BP 174/82; baseline vital signs were Bp 140/78, P72; no rash; hives or SOB noted; lungs clear; p/20 minutes VS returned to baseline status;									Y	11/04/1992	11/04/1992	0	NONE	OTH	OTH	Prednisone, Tagamet, Premarin, Provera, Synthroid, Salfalete, Levsniex	NONE	allergies-PCN, Cleocin, Compaizne, Tetracycline, telectin etc; rheumatoid arthritis, irritable bowel, partial thyrodectomy	~ ()~~~In patient		1						1	Dizziness; Hypertension; Tachycardia	FLU3~LEDERLE LABORATORIES~337907~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0048076	12/15/1992	MI	67.0	67		F	12/10/1992	severe local reaction suspected-deltoid tenderness & dec ROM; swelling of lt arm numbness & tingling in finger tips;				Y					U	10/07/1992	10/07/1992	0	under eval-no neuro deficits found	PVT	PVT		NONE	NONE (denies egg/chicken allergy)	~ ()~~~In patient		1						1	Hypokinesia; Injection site pain; Oedema; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~2F31118~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0048077	12/15/1992	GA	45.0	45		F	10/30/1992	pt revd vax @ 9AM; nasal congestion @ 920AM; rapid heart rate 100-110 @ 10AM, dizziness, h/a, cont heart rate, elevated BP; rx given;				Y						10/30/1992	10/30/1992	0		OTH	PUB		NONE	hx of multiple mild substance allergies	~ ()~~~In patient		1						1	Dizziness; Headache; Hypertension; Rhinitis; Tachycardia	FLU3~PARKE-DAVIS~01672P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0047734	12/16/1992	WA	59.0	59		M	11/20/1992	pt recvd flu vax 13OCT92 & on 24OCT92 was adm to hosp & given dx GBS; since then transferred to another hosp & under neurologist care;			Y		Y	20			U	10/13/1992	10/24/1992	11		OTH	OTH	NONE	Diabetes	pt is diabetic, non insulin dependent; no hx of allergies to meds;	~ ()~~~In patient	892329001E	1						2	Back pain; Guillain-Barre syndrome; Paraesthesia; Paralysis; Guillain-Barre syndrome	FLUX~PFIZER\WYETH~4928243~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928243~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation	Influenza
0048145	12/16/1992	MO	37.0			F	12/14/1992	pt reported to clinc; hospitalization for a papillary fibroelastoma tumor on mitral valve which caused an occlusion of the main artery to the optic nerve of the lt eye; presented to ER 16NOV92;				Y	Y				Y	10/29/1992	11/16/1992	18	NONE	PVT	PVT	UNK	NONE	UNK	~ ()~~~In patient		1						1	Arterial thrombosis; Neoplasm	FLUX~PFIZER\WYETH~4928114~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0047813	12/17/1992	CT	61.0	61		M	11/25/1992	pt recvd flu vax 27OCT92 & 16NOV92 exp difficulty walking & facial paralysis & was hospitalized; pt was given a dx of GBS;				Y	Y				U	10/27/1992	11/16/1992	20		PUB	PUB	UNK	NONE	UNK	~ ()~~~In patient	892336001E	1						2	Facial palsy; Gait disturbance; Guillain-Barre syndrome; CSF test abnormal; Facial palsy; Guillain-Barre syndrome; Hypokinesia; Hyporeflexia; Myasthenic syndrome; Neuropathy; Paraesthesia	FLUX~PFIZER\WYETH~4928149~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928149~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0048153	12/17/1992	NJ	43.0	43		M		myalgia x 12 hrs noc of vax, dec taste, salivation, micturation, devel w/low back pain & mild radicular sx x 1-2 days then upper thoracic pain & on & off w/paresthesias & dysathesia T3-T6 dermatomes; polyneuritis; dx aseptic meningitis;				Y					U	11/22/1991	11/22/1991	0	dx polyneuritis vs lyme & aseptic meningitis vax rxn; CBC, SMA, r/o lyme serology; CSF 6DEC inc prot & inc mono-aseptic meningitis; 18DEC CSF lower but still high-lyme pending on CSF;	PVT	PVT	Procardia	NONE	HTN, inc Chol	~ ()~~~In patient	CO4056	1						1	Asthenia; CSF test abnormal; Chest pain; Diplopia; Meningitis; Neuritis; Oliguria; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~1F21212~3~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0048158	12/17/1992	NE	47.0	47		F	12/02/1992	17NOV92 6PM sudden elevated temp & chills; no fever 18NOV92; so went to work 18NOV92 6PM elevated temp, chills & sl sore throat; had fever, chills, body aches, sore throat & cough;				Y					Y	10/26/1992	11/17/1992	22	NONE	OTH	PUB	Dyazide	NONE	Menier's disease	~ ()~~~In patient	NE9232	1						1	Asthenia; Bronchitis; Condition aggravated; Cough; Dizziness; Myalgia; Pharyngitis; Pyrexia	FLUX~PFIZER\WYETH~4928215~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048166	12/17/1992	VA	52.0	52		F	10/28/1992	on 17NOV92 low grade fever, on 19NOV92 pain under lt arm & across lt breasts-redness & swelling, very sl on 18OCT92;				Y					Y	10/16/1992	10/17/1992	1	IVP on 26OCT92;	PUB	PVT			allergy PCN, Sulfa, & Codeine-cyst on kidney	~ ()~~~In patient	VA92129	1						1	Breast pain; Oedema; Pain; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~2F31003~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0048167	12/17/1992	FL	62.0	62		M	11/17/1992	Guillain Barre syndrome;					Y			Y		10/20/1992	10/24/1992	4	LP, EMG;	PUB	PUB	Mevacor, Vitamins	NONE	ASHD, S/PCABG	~ ()~~~In patient	FL92076	1						1	Guillain-Barre syndrome	FLU3~PARKE-DAVIS~00192P~3~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation,Disabling	Influenza
0048177	12/18/1992	CA	81.0	81		M	11/23/1992	15NOV cold/flu sx; 17NOV fainted x 2; eval by MD;				Y					Y	11/03/1992	11/15/1992	12		PUB	PUB	NONE	NONE	MI in 1974	~ ()~~~In patient	CA92151	1						1	Influenza; Pharyngitis; Rhinitis; Syncope	FLUX~PFIZER\WYETH~4928234~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048178	12/18/1992	CA	79.0	79		F	11/23/1992	15NOV cold/flu sx plus severe nausea & vomiting; treated @ ER w/antiemetics & IV fluids;				Y					Y	11/03/1992	11/15/1992	12	NONE	PUB	PUB	NONE	NONE	gout; asthma;	~ ()~~~In patient	CA92152	1						1	Influenza; Nausea; Pharyngitis; Rhinitis; Vomiting	FLUX~PFIZER\WYETH~4928234~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048180	12/18/1992	CA	60.0	60		F	11/13/1992	started to itch 4 hrs p/shot was given; no rash seen; pt itches placed on DPH & cortisone cream per MD;									Y	11/05/1992	11/05/1992	0	NONE	PVT	PUB	Prolixin, Tapazole	Thyroid & nerves	Thyroid & nerves	~ ()~~~In patient	CA92154	1						1	Pruritus	FLUX~PFIZER\WYETH~4928234~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0048182	12/18/1992	CA	76.0	76		M	11/09/1992	fever to 103.5 x 2 wks, chills, noc sweats, muscle aches; flatus, no fever p/7NOV92;				Y						10/17/1992	10/24/1992	7	LFT's; sonogram of liver, CXR;	OTH	PUB	Inderal, Hydralazine	NONE	hypertension	~ ()~~~In patient	CA92156	1						1	Chills; Flatulence; Hepatic function abnormal; Hyperhidrosis; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048183	12/18/1992	CA	73.0	73		M	11/19/1992	fever 102 x 2 days; chills, severe shakes x 1 day, congestion-nasal 3 days, swollen nose x 4 days, tender sub-lingual glands x 4 days;									Y	11/16/1992	11/17/1992	1	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	CA92157	1						1	Chills; Face oedema; Lymphadenopathy; Pyrexia; Rhinitis; Tremor	FLUX~PFIZER\WYETH~4928234~6~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0048184	12/18/1992	CA				F		the day p/receiving flu shot, became very weak; appetite is diminished & pt is having lower gastro intestinal tract discomfort (gas pains); last few wks, has had low grade fever 99.6;				Y						10/14/1992	10/15/1992	1		OTH	PUB	Mylicon simethicone, milk of Magnesia, Metamucil		diverticulosis	~ ()~~~In patient	CA92158	1						1	Abdominal pain; Anorexia; Asthenia; Pyrexia	FLUX~PFIZER\WYETH~4928219~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048185	12/18/1992	CA	90.0	90		M	12/01/1992	17OCT92 very weak & coughing, head not clear; 21OCT92 taken to ER for eval then to daughters home for 4 days; was told @ er that probably had rxn to flu vax; 3DEC91 still coughing;				Y					Y	10/16/1992	10/17/1992	1	chem panel, CBC & UA @ ER;	PUB	PUB	Aspirin	NONE	legally blind-heart irregularities	~ ()~~~In patient	CA92159	1						1	Asthenia; Condition aggravated; Confusional state; Cough	FLUX~PFIZER\WYETH~4928234~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048186	12/18/1992	CA	85.0	85		M	11/23/1992	w/in 10 mins tingling in lt hand fingertips & lt side of mouth & lips; only persistent findings is tingling in fingertips;				Y						10/22/1992	10/22/1992	0	NONE	PUB	PUB		NONE	NONE	~ ()~~~In patient	CA92160	1						1	Paraesthesia	FLUX~PFIZER\WYETH~4928234~6~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048192	12/18/1992	MD	55.0	55		F	11/17/1992	23OCT92 PM rt arm @ site hurt terrible x 4 days; 6NOV92 loss of appetite, malaise, fever of 101.2, muscle aching, chills w/h/a, nausea;				Y						10/23/1992	10/23/1992	0		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MD92097	1						1	Anorexia; Chills; Headache; Injection site pain; Malaise; Myalgia; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~2F31171~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0048199	12/18/1992	VT	59.0	59		F	12/08/1992	joint swellings-hands, itchy feet w/tingling;				Y					Y	11/27/1992	12/04/1992	7	CBC, lytes, ESR-all nl;	PVT	PVT			erythromycin/Naprosyn	~ ()~~~In patient		1						1	Osteoarthritis; Paraesthesia; Pruritus	FLUX~PFIZER\WYETH~4928115~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048204	12/18/1992	CA	20.0	20		F	11/30/1992	rash over lt arm & chest immediately p/flu shot; came & went over 3 days;				Y					Y	11/19/1992	11/19/1992	0	NONE	PVT	PVT	NONE		PCN, Sulfa	~ ()~~~In patient		1						1	Rash	FLU3~CONNAUGHT LABORATORIES~2F31003X~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0048218	12/21/1992	IL	29.0	29		F	11/30/1992	approx 3-5 days post vax pt devel numbness & tingling in alternating extremities beginning in lt foot & lt calf muscle, then lt ant lat thigh; that which awakened during the noc & was most discomfort of all;									Y	11/06/1992	11/09/1992	3	NONE	PUB	UNK	NONE	NONE	NONE	NA~ ()~~~In patient	IL92114	1						1	Anorexia; Headache; Insomnia; Pain; Paraesthesia; Somnolence	FLU3~CONNAUGHT LABORATORIES~2F31149~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0048220	12/21/1992	MO	63.0	63		F	12/09/1992	pain behind rt scapula 19NOV92; x-rays neg 23NOV92 tx Lodine; 25NOV92 referred to Orthopedic MD injected steroids no relief; also loss of energy, loss of appetite & low grade temp;				Y					U	10/22/1992	11/19/1992	28		PUB	PUB	Micronase, Mevacor, Ogen, Provera	NONE	allergic to Demerol, Tetanus & Iodine dies; diabetes, coronary artery disease, chrondro Sarcoma;	NONE~ ()~~~In patient	MO92091	1						1	Anorexia; Asthenia; Pain; Pyrexia	FLU3~PARKE-DAVIS~01772P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0048242	12/21/1992	MA	76.0	76		M	12/08/1992	1 wk p/vax runny nose, sore throat, cough; 23NOV92 seen by MD p/episode w/back-sensation across base of back-up spine to head; pain in back; dx fracture lumbar; 30NOV92 MD again dx pneumonia;				Y					U	10/13/1992	10/20/1992	7		PUB	PUB		NONE	pace maker-total hip replacement-total knee replacement;	~ ()~~~In patient	MA9337	1						1	Back pain; Cough; Pathological fracture; Pharyngitis; Pneumonia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048244	12/21/1992	HI	34.0	34		F	12/16/1992	11DEC92 (2 days p/vax) pt states had runny nose, coughing-moist mucous, c/o h/a & sore throat; 13DEC92 pt was assessed by MD; lungs found to be tight sounding w/inspiratory/expiratory wheezing; tx for flare up of chronic bronchitis;				Y					U	12/08/1992	12/11/1992	3	no blood tests done/PE only;	OTH	PUB	NONE	occl flare up of chronic bronchitis	occl flare up of chronic bronchitis but none since OCT/NOV92 w/o acute epiosde in DEC92;	~ ()~~~In patient		1						1	Asthma; Bronchitis; Condition aggravated; Cough; Headache; Pharyngitis; Rhinitis	FLU3~PARKE-DAVIS~00192P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0048251	12/21/1992	WI	39.0	39		F	10/28/1992	devel olive sized swelling w/tenderness in lt thoracic lymph node 16OCT92;  had recvd flu vax in lt delotid 15OCT92; no other signs or sx swelling & tenderness lasted 1 wk;									Y	10/15/1992	10/16/1992	1	NONE	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Lymphadenopathy	FLUX~PFIZER\WYETH~4928132~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0048254	12/21/1992	MA	62.0	62		F	12/18/1992	30OCT recvd flu shot 13NOV got flu like s/s for 2 wks w/cough req codeine syrup; bronchial cough w/yellow sp production;									Y	10/30/1992	11/13/1992	14	NONE	PUB	OTH	Synthroid, Zestaril, MVI, Reglan, Xanax, Zantac	NONE	all to sulfa, HTN, dec thyroid, herminatial disc, hiatal hernia, bronchectasis	NONE~ ()~~~In patient		1						1	Cough; Infection; Influenza	FLUX~PFIZER\WYETH~4928230~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050213	12/21/1992	MS	61.0	61		F	11/20/1992	pt had gotten an inject on Friday & on Sunday noticed a lump @ site; then on Monday rash on body devel; went to dermatologist who stated pt was having a rxn to flu vax;									Y	10/30/1992	11/01/1992	2	NA	PUB	PUB	NONE	NONE	NA	NA~ ()~~~In patient	MS9265	1						2	Injection site mass; Rash	FLUX~PFIZER\WYETH~4928149~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0027738	12/22/1992	TX	74.0	74		M		gums swollen, upper lip tender & puffy & dry causing pt to constantly wet w/tongue; also this condition is annoying especially @ noc;									N	11/10/1988				UNK	PUB		NONE	NONE	~ ()~~~In patient	CO4131	1						2	Face oedema; Gingivitis; Pain	FLU3~CONNAUGHT LABORATORIES~8F91126~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0037215	12/22/1992	VA	47.0	47		M	02/14/1992	pain in lt shoulder first noticed 7NOV91; limitation of movement noted in early DEC, seen by MD; pain & limitation inc; dx adhesive capsulitis;				Y					U	10/31/1991	11/07/1991	7		PUB	PUB	Azmacort	NONE	asthma/sinusitis	NA~ ()~~~In patient	CO4086	1						2	Arthritis; Hypokinesia; Injection site pain; Pain; Hypokinesia; Pain	FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0046562	12/22/1992	NC	65.0	65		M	10/30/1992	h/a back part of head; flu-like sx, no fever or resp c/o;									N	10/07/1992	10/24/1992	17		UNK	UNK		NONE	empysema & hypertension	~ ()~~~In patient	CO4496	1						2	Headache; Influenza; Myalgia; Headache; Influenza	FLU3~CONNAUGHT LABORATORIES~2F31150~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~2F31150~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0046665	12/22/1992	NC	41.0			F	10/28/1992	rash across chest & lt arm; no fever or swelling;									Y	10/27/1992	10/28/1992	1		UNK	UNK	over the counter meds	NONE		~ ()~~~In patient	CO4506	1						2	Rash; Thirst; Rash	FLU3~CONNAUGHT LABORATORIES~2731150~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0046730	12/22/1992	NC				F	11/02/1992	pt recvd vax 22OCT92 c/o redness, pain & swelling @ site & surrounding area next day; tx for 3-4 days w/warm compresses; to MD 30OCT92 recvd inject & po meds; area still red & warm to touch today;									Y	10/22/1992	10/23/1992	1	NONE	PUB	PVT	Niacin, BP meds	NONE	elevated BP	~ ()~~~In patient	CO4507	1						2	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation; Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~2F31150~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~2F31150~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0048755	12/22/1992	MA	59.0	59		M	11/23/1992	redness @ site, rash down to forearm; prickly raised, then spread over body, groin & arms; MD described rash as generalized, diffusely erythematous, papular-type rash & probably allergic reaction to flu shot;				Y					N	10/23/1992				UNK	UNK	BP meds for 6 mons	bruns being treated w/Silvadene	NKA	~ ()~~~In patient	CO4524	1						2	Hypersensitivity; Injection site hypersensitivity; Rash; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~2F31117~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0049222	12/22/1992	MD	36.0	36		F	12/03/1991	rxn blisters on lips, stiffness in neck;									Y	11/15/1991			NONE	PVT	PVT	Seldane-D		seasonal allergic rhinitis, dermographism, eczema	NA~ ()~~~In patient	CO4031	1						1	Mouth ulceration; Nuchal rigidity	FLU3~CONNAUGHT LABORATORIES~1F21201~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049223	12/22/1992	WA	27.0	27		F	11/13/1992	nausea started same noc as infect x 2 days;									Y	11/01/1991			NONE	PVT	OTH	NONE	NONE	NONE	pt exp nausea;~ ()~~~In patient	CO4040	1						1	Nausea	FLU3~CONNAUGHT LABORATORIES~1F21121~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049224	12/22/1992	WA	59.0	59		F	11/27/1991	25OCT 1230PM vax recvd & 27OCT 1030PM few hives on rt back (upper), 1130PM itchy, more hives on body; 28OCT 7AM hives all over body & upper thighs & very itchy; 10AM seen by MD given med;				Y					Y	10/25/1991	10/27/1991	2		PVT	OTH	Premarin, Lasix, CA, Synthroid, Vitamins	NONE	NONE	~ ()~~~In patient	CO4041	1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~1F21120~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0049225	12/22/1992	OH				U	01/02/1992	3 office personnel recvd the flu shot in October & in December came down w/type a flu;									Y				cultures & titers were drawn;	UNK	UNK				~ ()~~~In patient	CO4061	1						1	Drug ineffective; Infection; Influenza	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049226	12/22/1992	OH				U	01/02/1991	3 office personnel recvd the flu shot in October & in December came down w/type a flu;									Y				cultures & titers were drawn	UNK	UNK				~ ()~~~In patient	CO4062	1						1	Drug ineffective; Infection; Influenza	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049227	12/22/1992	OH				U	01/02/1992	3 office personnel recvd the flu shot in October & in December came down w/type a flu;									Y				cultures & titers were drawn;	UNK	UNK				~ ()~~~In patient	CO4063	1						1	Drug ineffective; Infection; Influenza	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049228	12/22/1992	CA				M	02/07/1992	w/in 4 hrs devel rash cont to recover w/pruritus & welts covering hips, ribs, & elbows; also saw dentist that afternoon & had dental work				Y					U					PUB	PUB	Cardiac & antihypertension drugs;		cardiovascular on multiple RXS	~ ()~~~In patient	CO4072	1						1	Pruritus; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~0F11203~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0049230	12/22/1992	CA	25.0	25		F	01/16/1992	fever, spiking 103, 3 hrs post inject; 2nd day feeling better; 3rd day no fever or h/a;									Y	01/14/1992	01/14/1992	0	NONE	PVT	PVT		NONE	excercise induced asthma;	~ ()~~~In patient	CO4097	1						1	Pyrexia	FLU3~CONNAUGHT LABORATORIES~1F21217~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049231	12/22/1992	TX	61.0			F		5NOV91 pt exp local reaction @ the site of flu vax resulting in extreme heat, erythema & induration of the rt deltoid muscle, 15 by 16 cm in size; also inflammation of the site; pt is allergic to PCN;										11/05/1991	11/05/1991	0		UNK	UNK	Premarin, Synthroid;			~ ()~~~In patient	CO4104	1						1	Injection site hypersensitivity; Injection site inflammation; Injection site mass; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~1F21216~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0049232	12/22/1992	NY	49.0	49		F	12/25/1991	blurring vision 3 wks p/flu shot;segmental loss of vision which caused localized loss of vision in lt eye as revealed by field of vision exam;									N	10/02/1991	10/23/1991	21		PVT	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient	CO4110	1						1	Amblyopia; Visual field defect	FLU3~CONNAUGHT LABORATORIES~1F21207~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049233	12/22/1992	IA	38.0	38		F	02/11/1992	Eosinophilia 2 days post inject started w/itchy rash; by 1DEC hospitalized blood results for Eosinophilia were 30; bone marrow test done also;					Y				N	10/07/1991	10/09/1991	2		PVT	UNK	Dyazide, Talacen	NONE	NONE	~ ()~~~In patient	CO4138	1						1	Eosinophilia; Pruritus; Rash; Eosinophilia; Urticaria	FLU3~CONNAUGHT LABORATORIES~1F21203~4~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~1F21203~6~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0049233	12/22/1992	IA				F	03/19/1992	hives on abdo & legs & trunk 2 days p/inject; started on Pred & cont until 28OCT; no on DPH & Sinequan; seen by MD;										10/07/1991	10/09/1991	2	Hepatitis scren neg; Sed rate WNL, Chem screen, ANA-all neg; CBC-inc EOS;	UNK	UNK				~ ()~~~In patient	CO4154	1						2	Eosinophilia; Pruritus; Rash; Eosinophilia; Urticaria	FLU3~CONNAUGHT LABORATORIES~1F21203~4~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~1F21203~6~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0049235	12/22/1992					F		swollen gums & lips;										11/10/1988				UNK	UNK				~ ()~~~In patient	CO4132	1						1	Face oedema; Gingivitis	FLU3~CONNAUGHT LABORATORIES~8F41126~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049237	12/22/1992	CA				F	03/19/1992	severe myalgia, diarrhea, weakness 7 days p/inject;									Y				sed rate;	PVT	PVT	Norpace, digotoxin		NONE	~ ()~~~In patient	CO4157	1						1	Asthenia; Diarrhoea; Myalgia	FLU3~CONNAUGHT LABORATORIES~~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049238	12/22/1992	FL	28.0	28		M	02/11/1992	sore arm-6 mon p/flu shot; @ time of shot no local rxn-no swelling-no induration; seen by pvt MD was given sterioids & ATB;									N	11/15/1991				UNK	UNK				~ ()~~~In patient	CO4160	1						1	Myalgia; Hypokinesia; Neck pain; Pain	FLU3~CONNAUGHT LABORATORIES~1F21209~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~1F21209~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0049238	12/22/1992	FL	28.0	28		M	03/31/1992	pain in upper arm & shoulder, 11 days p/recvd flu shot; still discomfort 6 months p/unable to abduct lt arm; c/o pain radiating to neck;									N	11/15/1991	11/26/1991	11	MRI of shoulder-neg; x-rays-neg;	OTH	OTH	NSAID's, Medrol	did not see pt then	acute problems only	~ ()~~~In patient	CO4192	1						2	Myalgia; Hypokinesia; Neck pain; Pain	FLU3~CONNAUGHT LABORATORIES~1F21209~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~1F21209~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0049240	12/22/1992	MO	70.0			F	06/05/1992	painful arm, long glove distribution on upper distal extremities; some weakness, can not use hands; some leg pain w/sl amount of edema; better @ times when treated w/steroids;				Y					N	10/01/1991			nerve studies nl;	UNK	UNK				~ ()~~~In patient	CO4271	1						1	Asthenia; Oedema peripheral; Pain	FLU3~CONNAUGHT LABORATORIES~1F21213~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0049241	12/22/1992	NJ	40.0	40		M	06/19/1992	neuritis, myocytis in the lt deltoid; treated w/physicial therapy & non steroidals;									U	10/31/1991	11/21/1991	21		MIL	MIL		NONE	1 epidosemechanical low back pain	~ ()~~~In patient	CO4339	1						1	Myositis; Neuritis	FLU3~CONNAUGHT LABORATORIES~1J21118~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049242	12/22/1992	AZ	41.0	41		F	08/13/1992	swelling & redness w/in a day or so of inject; soft tissue injury which was debilitating; no systemic sx;					Y				Y	11/10/1991	11/11/1991	1		UNK	UNK				~ ()~~~In patient	CO4369	1						1	Injury; Oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~1J21108~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0049243	12/22/1992	NY				U	10/23/1992	3 wks p/1991-1992 flu vax pt devel Bell's Palsy;									Y					UNK	UNK				~ ()~~~In patient	CO4478	1						1	Facial palsy	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049244	12/22/1992	TX				U	10/23/1992	10 mins p/the inject devel itchy red rash in anticubital area of both arms; treated w/Atrarx & resolved in 1 wk;									Y					UNK	UNK				~ ()~~~In patient	CO4485	1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049245	12/22/1992	NY				U	10/23/1992	1 hr p/vax & immune globulin had itching all over body; called office & was prescribed DPH;														UNK	UNK	Immune globulin			~ ()~~~In patient	CO4486	1						1	Pruritus	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049246	12/22/1992	GA				M	10/23/1992	sore muscle & redness @ inject site; pt is very thin;									U	10/15/1992	10/15/1992	0		UNK	UNK				~ ()~~~In patient	CO4487	1						1	Injection site hypersensitivity; Myalgia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049247	12/22/1992	OH	46.0	46		F	10/23/1992	8 hrs p/inject devel 4x3 red square around inject site which was itchy; also itchy around eyes, hives; local reaction on arm disappeared; 1st reaction in 200 doses;									N	10/12/1992	10/12/1992	0		UNK	UNK	Pred		egg allergy as child but has received 6 prev flu shots w/o problems;	~ ()~~~In patient	CO4488	1						1	Injection site hypersensitivity; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~2F31112~7+~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049248	12/22/1992	GA	69.0	69		F	10/30/1992	rash @ inject site;									U	10/23/1992	10/27/1992	4		UNK	UNK	Zestril	weak  & tired	High BP, allergy to PCN & codeine	~ ()~~~In patient	CO4495	1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~2F31171~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049250	12/22/1992	NH	35.0			F	10/30/1992	red non-tender, non-pruritic, hot to touch; large arm, inject administered @ lower border of muscle insertion; no tx;				Y					N	10/26/1992	10/28/1992	2		UNK	UNK				~ ()~~~In patient	CO4502	1						1	Oedema peripheral; Vasodilatation; Diarrhoea; Headache	FLU3~CONNAUGHT LABORATORIES~2F31109~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~2F31109~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0049250	12/22/1992	NH				F	10/30/1992	diarrhea & h/a;									U	10/26/1992	10/28/1992	2		UNK	UNK				~ ()~~~In patient	CO4510	1						2	Oedema peripheral; Vasodilatation; Diarrhoea; Headache	FLU3~CONNAUGHT LABORATORIES~2F31109~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~2F31109~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0049251	12/22/1992	TX	70.0			M		facial paralysis; rt side of face, drooping mouth & eye w/numbnesss in mouth & rt side of tongue; ?Bell's palsy;				Y					N	10/27/1992	10/27/1992	0		UNK	UNK	lots		no allergies	~ ()~~~In patient	CO4503	1						1	Eyelid ptosis; Facial palsy; Hypotonia; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0049252	12/22/1992	NY				F	10/30/1992	Employee recvd inject & then returned next day w/tingling on the rt side of face, nausea & h/a; on exam noted swelling & mouth drooping;				Y					N	10/27/1992	10/28/1992	1		UNK	UNK				~ ()~~~In patient	CO4504	1						1	Headache; Hypotonia; Nausea; Oedema; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0049255	12/22/1992	PA	28.0	28		F	10/30/1992	started w/rash on neck & then vomited & diarrhea w/some resp problem; seen in ER given DPH; 29OCT92 still feeling nauseated; prescribed Medrol dose pak;				Y					N	10/26/1992	10/27/1992	1		UNK	UNK	NONE		no allergies	~ ()~~~In patient	CO4509	1						1	Diarrhoea; Dyspnoea; Nausea; Rash; Vomiting	FLU3~CONNAUGHT LABORATORIES~2F31150~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0049257	12/22/1992	PA				F	11/09/1992	total body swelling (puffy) & achy all over pain in joints; treated w/Naprocin;				Y					U	10/22/1992	10/24/1992	2		UNK	UNK				~ ()~~~In patient	CO4511	1						1	Arthralgia; Generalised oedema; Myalgia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0049258	12/22/1992	IL	37.0	37		M	11/14/1992	unidentified reaction;				Y					U	10/27/1992	10/27/1992	0		UNK	UNK				~ ()~~~In patient	CO4513	1						1	Pruritus; Tongue oedema; Urticaria	FLU3~CONNAUGHT LABORATORIES~2F31142~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0049259	12/22/1992	CT				F	11/02/1992	dizziness, headache, sl vomiting, also some local erythema; had to leave work 2NOV92;									N	10/29/1992	10/31/1992	2		UNK	UNK				~ ()~~~In patient	CO4515	1						1	Dizziness; Headache; Injection site hypersensitivity; Vomiting	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049260	12/22/1992					U	11/19/1992	Unilateral neuropathy in peroneal area; Did not want to provide addtl details; no other info expected;									N					UNK	UNK				~ ()~~~In patient	CO4519	1						1	Neuropathy	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049261	12/22/1992	PA	38.0	37		F	11/19/1992	sore throat on lt side, sneezing, coughing & fever; feel lousy;									N	11/02/1992	11/02/1992	0		UNK	UNK				~ ()~~~In patient	CO4521	1						1	Cough; Malaise; Pharyngitis; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~2F31170~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049263	12/22/1992	MD	48.0	48		F	12/07/1992	w/in 2-3 mins arm became very itchy & red; no systemic reaction; over the next day devel flu-like sx w/local reaction characterized by induration, red & hot to touch; had vax last yr;									N	11/10/1992	11/10/1992	0		UNK	UNK				~ ()~~~In patient	CO4540	1						1	Influenza; Injection site hypersensitivity; Injection site mass; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~2F31097~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049264	12/22/1992	NY	57.0	56		M	12/07/1992	swelling of legs, face & arms; no medication or known drug allergies; works as a groom @ race track; exposed to many environmental elements;				Y					N	11/05/1992	11/12/1992	7		UNK	UNK				~ ()~~~In patient	CO4545	1						1	Face oedema; Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0049265	12/22/1992	IN	66.0			F	12/07/1992	chills, t101, aching & rash on upper abdo, trunk & face 6-12 hrs p/inject; looked like a bad sunburn;									U	11/16/1992	11/16/1992	0	WBC 19,000	UNK	UNK				~ ()~~~In patient	CO4558	1						1	Chills; Myalgia; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~2F31099~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0038343	12/23/1992	MA	69.0			F	11/10/1992	24 hrs following vax became ill w/earaches, sore throat, bad cold, severe coughing; no fever; called MD; as of 10NOV92 pt still having same sx;									N				NONE	PUB	PUB		NONE		~ ()~~~In patient	MA9228	1						1	Cough; Ear pain; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4928230~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0039346	12/23/1992	CO	31.0	31		F	11/25/1992	pt recvd vax & exp severe pain-abdominal upper rt quadrant; 2 hrs later chills, fever; seen by MD 24NOV & t102 orally; cough began 23NOV, mucus in throat & MD then was pus in back of throat;				Y					Y	11/18/1992	11/21/1992	3		PUB	PUB	NONE	NONE	allergies to dust, mold & animal dander;	NONE~ ()~~~In patient	CO9296	1						1	Abdominal pain; Chills; Cough; Infection; Pharyngitis; Pyrexia	FLUX~PFIZER\WYETH~4928223~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048414	12/23/1992	GA	54.0	54		F	10/14/1992	pt stated inject site started swelling, got red & hot w/hard knot; could hardly raise arm; felt arm getting better so did not go to MD; 4 1/2 diameter around inject site, sl darker in color; 1 in knot noted @ inject site;									Y	09/30/1992	10/02/1992	2		PUB	PUB	BP meds-name unk	NONE	NONE	~ ()~~~In patient	GA92209	1						1	Hypokinesia; Injection site hypersensitivity; Injection site mass; Injection site oedema; Pain; Skin discolouration; Vasodilatation	FLUX~PFIZER\WYETH~4928233~5~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0048415	12/23/1992	GA	77.0	77		F	10/15/1992	930AM 12OCT92 MD office w/nausea, weak; hx of heart disease; BP 162/50-sent ot ER expired 1152 12OCT92 w/prob dx of myocardial infarction;	Y	10/12/1992							N	10/08/1992	10/12/1992	4		PUB	UNK		hx of coronary problems		~ ()~~~In patient	GA92210	1						1	Cardiovascular disorder; Myocardial infarction; Nausea; Shock	FLUX~PFIZER\WYETH~4928243~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0048417	12/23/1992	GA	86.0	85		F	10/20/1992	approx 15-20 mins p/vax pt exp breathing difficultes; EMS called 02 administered & pt transported to ER; pt was treated w/02, breathing therapy & meds;				Y					Y	10/20/1992	10/20/1992	0		PVT	PVT				~ ()~~~In patient	GA92212	1						1	Dyspnoea	FLU3~PARKE-DAVIS~00682P~7+~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0048422	12/23/1992	GA	82.0	82		F	10/23/1992	pt had flu shot & pneumonia vax & returned this PM w/swollen area @ site of prev vax inject, warm to touch, dizziness & headache;				Y					U	10/23/1992	10/23/1992	0		PUB	PUB	Doxepin, Inderal, Tentex	NONE	hypoglycemia, nerves in feet & legs are deteriorating	NONE~ ()~~~In patient	GA92217	1						1	Dizziness; Headache; Injection site oedema; Vasodilatation	FLU3~PARKE-DAVIS~00292P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~308904~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0048431	12/23/1992	GA	69.0	69		F	11/11/1992	pt recvd vax 9NOV92 noticed knot & redness 10NOV92; itching localized to erythemic area; upon exam large are of upper arm is reddened & warm to touch, sl induration where vax given;									Y	11/09/1992	11/10/1992	1	NONE	PUB	UNK	BP med, Diaretic-ANtiripolene	NONE	PCN, Sulfa; Hypertension, Emphesema	NONE~ ()~~~In patient	GA92226	1						1	Injection site hypersensitivity; Injection site mass; Pruritus; Vasodilatation	FLU3~PARKE-DAVIS~00192P~4~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0048432	12/23/1992	GA	60.0	60		M	11/16/1992	wife states that evening of immun, pt devel a high fever & welts on lt arm; fever has cont through 9NOV92; low grade now by 7NOV92 welts were over entire body;									Y	11/06/1992	11/06/1992	0		PUB	PUB	NONE	UNK	heart patient	NONE~ ()~~~In patient	GA92228	1						1	Pyrexia; Urticaria	FLUX~PFIZER\WYETH~4928233~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1301T~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0048433	12/23/1992	GA	42.0	42		F	11/17/1992	pt recvd vax & rt arm was sore & began to hurt; pt began to have pain in arm & then under arm that noc; next morning had a red streak @ site of inject; MD ER dx as lymphenitis;				Y						11/11/1992	11/11/1992	0		PUB	PUB				~ ()~~~In patient	GA92229	1						1	Lymphadenopathy; Myalgia; Pain; Skin striae	FLU3~LEDERLE LABORATORIES~337909~1~~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|PPV~PFIZER\WYETH~334957~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0048436	12/23/1992	GA	73.0	73		F	11/19/1992	cold, sore throat, t102.4 starting 8 days p/vax given; pt recvd Ceclor;									Y	11/02/1992	11/10/1992	8	NONE	PUB	PUB	Lanoxin, Endural	NONE	Myoloma	pt exp cough in 60's (age) w/flu vax;~ ()~~~In patient	GA92232	1						1	Pharyngitis; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~00292P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0048448	12/24/1992	DE	69.0	68		M	12/15/1992	sore throat, h/a, pain in lt side of chest, mild nausea;				Y					N	11/16/1992	12/06/1992	20	NONE	PUB	PUB	NONE	NONE	NONE	NA~ ()~~~In patient	DE9210	1						1	Chest pain; Headache; Nausea; Pharyngitis	FLUX~PFIZER\WYETH~4928226~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~308914~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0047857	12/29/1992	PA	74.0	74		F	11/30/1992	pt died 9 hrs p/vax; pt had hypertension & end-state COPD & recvd pneumococcal vax @ the same time;	Y	11/06/1992							N	11/05/1992	11/06/1992	1	NA	PVT	OTH	NA		severe hyperlipidemia, hypertension, end stage chronic obstructive pulmonary disease; allergic to dust;	NA~ ()~~~In patient	920389201	1						2	Cardiovascular disorder; Hyperhidrosis; Hypertrophy; Malaise; Myocardial infarction; Stupor; Condition aggravated	FLU3~LEDERLE LABORATORIES~335914~1~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|PPV~MERCK & CO. INC.~0100V~1~~~PNEUMO (PNEUMOVAX)~1|FLU3~LEDERLE LABORATORIES~335914~1~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~2|PPV~MERCK & CO. INC.~0101V~1~~~PNEUMO (PNEUMOVAX)~2	USA	Results in Death	Influenza
0048455	12/29/1992	KS	59.0	59		M	11/18/1992	pt was vaxed 30OCT92; 12NOV pt exp a fever of 102 & leukopenia (WBC=1700); pt was hospitalized 4 days;					Y	4			U	10/30/1992	11/12/1992	13	WBC 1700	PVT	PVT	NONE		1 episode of idiopathic thrombocytopenia purpura;	NA~ ()~~~In patient	920385701	1						1	Leukopenia; Pyrexia	FLU3~LEDERLE LABORATORIES~335915~1~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation	Influenza
0048459	12/29/1992	AK	44.0	44		F	11/13/1992	given MMR/Flu vax 27OCT92; week of 9NOV92 began having aching joints w/swollen lymph glands in neck; taking aspirin; has not seen MD;									N	10/27/1992	11/09/1992	13		PUB	PUB		NONE	NONE	~ ()~~~In patient	AK92030	1						1	Arthralgia; Lymphadenopathy	FLUX~PFIZER\WYETH~4928285~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0456V~1~SC A~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0048460	12/29/1992	AK	53.0	53		F	11/09/1992	lt upper arm began swelling the noc of the vax w/redness & pain; 1NOV92 there was a lump as large as a ping pong ball-redness & pain present;									Y	11/01/1992	11/01/1992	0		PUB	PUB		NONE	allergies to Tetanus-Diptheria vax & many meds	pt exp severe swelling involving much of arm @ 52 y/o w/Td booster;~ ()~~~In patient	AK92031	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~4928285~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0048461	12/29/1992	AK	63.0	63		F	10/28/1992	flu shot given 27OCT92; noticed rt eye tearing & some swelling of lids that noc; rt eye only; still some mild swelling of medial aspect of upper lower rt lid the next day;										10/27/1992	10/27/1992	0		PUB	PUB		NONE	hypertension; also on thyroid	~ ()~~~In patient	AK92032	1						1	Face oedema; Lacrimal disorder	FLUX~PFIZER\WYETH~4928285~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0048462	12/29/1992	AK	8.0	8		F	11/24/1992	pt exp fainting following vax; seen by MD dx heart block;				Y	Y					11/03/1992	11/06/1992	3		PUB	PUB	for asthma		asthma, cardiac congential problems;	~ ()~~~In patient	AK92033	1						1	Atrioventricular block; Syncope	FLUX~PFIZER\WYETH~4922828~5~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0048482	12/29/1992	TX	43.0	43		F	11/30/1992	c/o lt arm difficulty were shot was given hurts, unable hold chalk & write on black board; feeling of pain & numbness in arm; f/u MD GBS:				Y					U	11/06/1992	11/07/1992	1		PUB	PUB	NONE	denied	NONE	~ ()~~~In patient	TX92248	1						1	Guillain-Barre syndrome; Hypokinesia; Pain; Paraesthesia	FLUX~PFIZER\WYETH~4928207~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048487	12/29/1992	VA				F	12/15/1992	burning upper abdomen; chills, fever, nausea, body aches; no fever; difficulty reading sx began 7NOV92 & lasted aprpox 36-48hrs;									Y	10/26/1992	11/07/1992	12	NONE	PUB	PUB	NONE			NONE~ ()~~~In patient	VA92131	1						1	Abdominal pain; Chills; Myalgia; Nausea; Pyrexia; Visual disturbance	FLU3~CONNAUGHT LABORATORIES~2F31003~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0048491	12/29/1992	MN	89.0	89		F	12/21/1992	pt vaxed 12NOV92 & then onset progressive generalized weakness 17NOV92 worsening until 7DEC92 when hospitalized due to inability to care for self; currently receiving plasma exchange treatment-GBS;			Y		Y				N	11/12/1992	11/17/1992	5	presence of demyelmation on electromyography; spinal exam w/inc protein;	PVT	PVT	Captopril, Naproxen	recovering from hip arthroplasity	hypertension, ischemia heart disease, osteoarthritis;	NA~ ()~~~In patient		1						1	Asthenia; CSF test abnormal; Guillain-Barre syndrome; Neuropathy	FLUX~PFIZER\WYETH~4928222~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0048499	12/30/1992	AK	57.0	57		F	12/02/1992	pt recvd vax 28OCT92 stated arm felt sore & like a boil; 30OCT92 woke up w/nose & eye area beat red & broke out on other parts of body; p/being in water broke w/welts; seen by MD given DPH;				Y					Y	10/28/1992	10/30/1992	2	NONE	PUB	PUB	Provera, Ogen	NONE	PCN, CA of breast mastectomy 1981, heart attack 1981;	NONE~ ()~~~In patient	AK92039	1						1	Myalgia; Urticaria; Vasodilatation	FLUX~PFIZER\WYETH~4928285~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~302907~1~IM~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0048502	12/30/1992	MA	62.0	62		F		severe dry, constant, unproductive cough p/ER dx & p/x-rays pneumonia; date of exam 10DEC92;				Y					N	11/05/1992	11/10/1992	5	x-ray chest pneumonia;	PUB	UNK	Procardia, Hydoclorothia, Proventil, Atrovent, Vanceril	NONE	hypertension, COPD	~ ()~~~In patient		1						1	Cough; Pneumonia	FLUX~PFIZER\WYETH~4928230~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0047422	01/04/1993	NC	86.0	86		F	12/30/1992	t105 <24 hrs p/inject; hospitalized all cult nl; temp lasted <6 hrs & pt recovered;					Y	2			Y	10/26/1992	10/27/1992	1		PVT	UNK				~ ()~~~In patient		1						2	Pyrexia	FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0048584	01/04/1993	AR	64.0	64		M	10/28/1992	24OCT92 temp elevated to 103; 25OCT92 had convuls; MD felt not related to flu vax but unsure of cause;				Y	Y	5			Y	10/23/1992	10/25/1992	2	UNK	OTH	PVT	Naprosin, Macrodantin, Amitriptyline, Bactesen	multiple sclerosis	MS-urinary retention-diabetes	~ ()~~~In patient	AR9259	1						1	Convulsion; Pyrexia	FLUX~PFIZER\WYETH~4928228~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0048587	01/04/1993	CA	58.0	58		F	12/16/1992	awoke w/rt ear strange sensation on 5NOV92; had flu shot in AM; 6NOV had sore ear & dizziness which became progressively worse on 9NOV rt side of face paralysis w/vertigo, n/v; 21NOV went to ER for hydration; 26NOV hospitalized				Y	Y	6			U	11/05/1992	12/05/1992	30	dx Bell's palsy;dx Ramsey hunt synd;	PUB	PUB	NONE	rt ear strange sensation a/shot	hypoglycemic 1974-diet controlled	~ ()~~~In patient	CA92163	1						1	Dizziness; Ear pain; Facial palsy; Nausea; Vertigo; Vomiting	FLUX~PFIZER\WYETH~4928234~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0048588	01/04/1993	CA	67.0	67		F	11/02/1992	nausea, vomiting, very tired, cough dx bronchitis by MD;				Y					Y	10/20/1992	10/25/1992	5	NONE	PUB	PUB	Premarin, Vasitec, Tomaptic, eye gtts	NONE	High PB on tx Vasitec	NONE~ ()~~~In patient	CA92164	1						1	Asthenia; Bronchitis; Cough; Nausea; Vomiting	FLUX~PFIZER\WYETH~4928234~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048631	01/04/1993	MI	48.0	48		M	10/14/1992	8OCT92 devel cold sx-stuffy nose, body aches, fever, small red rash on face, neck, ears-gradual swelling of eyes, ears, face; ER visit 12OCT92;				Y						10/06/1992	10/08/1992	2	NONE	PUB	PUB	Diabenase, Cardiziem, Ecotrin	NONE	Diabetes	NONE~ ()~~~In patient	MI92144	1						1	Face oedema; Myalgia; Pharyngitis; Pyrexia; Rash; Rhinitis	FLUX~PFIZER\WYETH~4928241~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048632	01/04/1993	MI	71.0	71		F	10/20/1992	17OCT92 sl h/a all day, abdo cramping, then diarrhea x 2- nothing 18OCT-19OCT but cramps; also chills 17OCT92; vomited x 1 17OCT92;									Y	10/14/1992	10/17/1992	3	NONE	PUB	PUB		NONE	@ clinic JUL, AUG Cystoscopy--small tumor in bladder	~ ()~~~In patient	MI92145	1						1	Abdominal pain; Chills; Diarrhoea; Headache; Vomiting	FLUX~PFIZER\WYETH~4928111~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0048643	01/04/1993	MI	70.0	70		M		states recvd flu vax 26OCT92 & on 27OCT92 has been exp cramping in fingers, toes & legs;									U	10/26/1992	10/29/1992	3		PUB	UNK				~ ()~~~In patient	MI92158	1						1	Pain	FLUX~PFIZER\WYETH~4928213~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0048645	01/04/1993	MI	10.0	10		M	11/03/1992	stomachache, vomited, diarhea; t100, arm swelled to size of baseball bat; no other in family had severe local reaction; seen by MD 2NOV92;				Y					Y	10/30/1992	10/30/1992	0	NONE	PUB	PUB	NONE	NONE	bee stings allergy	NONE~ ()~~~In patient	MI92160	1						1	Abdominal pain; Diarrhoea; Oedema; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~2F31112~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0048649	01/04/1993	MI	65.0	65		F	10/11/1992	pt c/o sore throat, swollen glands, chills, sweats & body aches; also cold s/s; no local reaction; MD checked & stated it was not flu shot related;				Y					Y	10/07/1992	10/11/1992	4	CXR-neg;	PUB	PUB	Calan, Nitorbid, Diazide, Tonarium	last yr reacted the same	heart prob: fibulation, valve trouble & HTN;	pt exp mild rxn in 1991 @ 64 w/flu shot #1;~ ()~~~In patient	MI92164	1						1	Chills; Hyperhidrosis; Lymphadenopathy; Myalgia; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4928244~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048650	01/04/1993	MI	77.0	77		M	10/26/1992	c/o swollen feet, headache, no fever; no local reaction; pt was seen by MD, rheumatologist, dx'd acute condition occured suddenly & cleared spontaneously-probable adverse reaction to flu shot;				Y					Y	10/12/1992	10/16/1992	4	CXR neg; ACE Angiotensen-nl range, uricacio-nl;	PUB	PUB	Clarixol, Naprosin, metazol	NONE	sinus allergy	NA~ ()~~~In patient	MI92165	1						1	Headache; Oedema peripheral	FLUX~PFIZER\WYETH~4928220~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048651	01/04/1993	MI	68.0	67		F		c/o h/a, sore throat, nasal congest & chills; no local reaction; BP nl; refused to give MD's name; dx URI & gave Keflex; did minor surgery removing several cyst;				Y					Y	10/07/1992	10/17/1992	10	NONE	PUB	PUB	Uricholine, Porbinride, Aldomet	NONE	HTN, poor bladder tension-incomplete	NA~ ()~~~In patient	MI92166	1						1	Chills; Headache; Infection; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4928244~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048654	01/04/1993	MI	63.0	63		F	11/20/1992	16NOV92 began itching in groin area; by Tuesday had raised, red blotchy, itchy areas scattered in warm area of body; treated rash w/DPH cream;									Y	11/13/1992	11/16/1992	3	NONE	PUB	PUB	Premarin	NONE	allergic to PCN	NONE~ ()~~~In patient	MI92169	1						1	Pruritus; Rash maculo-papular	FLUX~PFIZER\WYETH~4928222~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0048655	01/04/1993	MI	36.0	36		F	11/04/1992	21OCT pt recvd vax; noc sore throat fire red, swollen neck glands-swollen ax glands, low grade fever 1 wk, green-yellow as drainage-bronchial; ER MD dx as flu vax rxn;				Y					Y	10/21/1992	10/21/1992	0		PUB	UNK	Theodur, ventolin	NONE	Asthma, Emphysema	pt's father exp flu sx 24 hrs;~ ()~~~In patient	MI92170	1						1	Infection; Lymphadenopathy; Pharyngitis; Pyrexia	FLUX~PFIZER\WYETH~4928229~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~334958~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0048656	01/04/1993	MI	9.0	8		M	11/18/1992	pt started vomiting p/15 mins MN 15NOV92, took to ER p/speaking w/MD; mom states WBC count went from 6,000 to 13,000; t104; pt had abd pain w/some referred pain; MD did appendectomy; mom informed p/surgery, probable was viral not bacteria;				Y	Y	3			Y	11/12/1992	11/15/1992	3		PUB	PUB	NONE	NONE	congential heart dx; hx of bad flu illness in past years	~ ()~~~In patient	MI92171	1						1	Abdominal pain; Infection; Pyrexia; Vomiting	FLUX~PFIZER\WYETH~4928241~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0803V~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Hospitalisation	Influenza
0048659	01/04/1993	MI	72.0	72		F	12/07/1992	approx 1 mo p/vax pt exp pain on lt side, shoulder, chest under breast; sx progressed to pain & swelling of knees & ankles to Er 25NOV r/o cardiac concerns; saw MD 26NOV for tests; mild discomfort joints, UTI;					Y	7				10/21/1992	11/22/1992	32	multiple diagnostic tests	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MI92174	1						1	Arthralgia; Chest pain; Osteoarthritis; Pain; Urinary tract infection	FLUX~PFIZER\WYETH~4928241~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0048664	01/04/1993	MI	77.0	77		M		3 days p/vax lt breast swollen & sore; couple days later rt breast swollen & sore; swelling & pain went down under rt arm also; joints swollen & sore have heat in them; hurt all over;									Y	10/23/1992	10/26/1992	3		PUB	UNK		NONE		~ ()~~~In patient	MI92183	1						1	Arthralgia; Breast pain; Oedema; Osteoarthritis; Pain	FLUX~PFIZER\WYETH~4928111~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0048672	01/04/1993	WV	82.0	82		F	11/30/1992	dyspnea, anxiety, P56, R36, BP 200/90, 02 on transferred to hosp; causes of death-cardiac failure, CHF, Ischemic cardiomyopathy, COPD; also exp discomfort & tingling in arms; R36 shallow & labored;	Y	11/22/1992							N	10/29/1992	11/22/1992	24	unk	PUB	PUB	Lasix, Lanoxin, Calan SR, Humulin, Axid, Nitrobid, Elavil, Nifedipineoth	NONE	CAD, IDDM, Hypertension, chronic CHF, cardiomegaly;	~ ()~~~In patient	WV9242	1						1	Anxiety; Cardiac arrest; Condition aggravated; Dyspnoea; Hypertension; Hyperventilation; Myocardial infarction; Paraesthesia	FLUX~PFIZER\WYETH~4928217~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0048673	01/04/1993	WV	79.0	79		F	11/30/1992	abdominal pain, poor appetite, pos UA;					Y	7			Y	10/29/1992	11/18/1992	20	WBC 1300 w/85SEGS & 5 lymphs, UA 2+ bacteria, TNTC WBC's;	OTH	PVT	Digoxin, Micro K, Aldomet, Nitrobid	NONE	old CVA, freq UTI, hypertension, PVD, (allergies Keflex, allopurinol, minipress, Caroten, Procardia);	~ ()~~~In patient	WV9243	1						1	Abdominal pain; Anorexia; Infection; Leukocytosis	FLUX~PFIZER\WYETH~4928217~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0048682	01/04/1993	PA	47.0	47		F	11/04/1992	hearing loss, dizziness, nausea & vomiting, vertigo, fell, lost balance;					Y		Y		U	10/16/1992	10/28/1992	12		OTH	OTH	Estraderm patch	NONE	NONE	~ ()~~~In patient		1						1	Coordination abnormal; Deafness; Dizziness; Nausea; Vertigo; Vomiting	FLU3~PARKE-DAVIS~01872P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0048683	01/04/1993	NJ	33.0			F		adm to hosp p/recvd flu vax approx 11 days w/demyelinating CNS lesion, ?cervical spine level; sx included progressive numbness, ataxia;					Y					11/02/1992				UNK	UNK			allergies codeine, erythromycin, IV Keflex; CNS demyelinating lesion, asthma, h/a, poss post vaccineal;	~ ()~~~In patient		1						1	Coordination abnormal; Neuropathy; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0048685	01/04/1993	WA	67.0			M	12/15/1992	Guillain-Barre Synd w/onset 10 days p/flu vax;					Y	21				11/16/1992	11/26/1992	10	neurology consult; spinal fluid exam showing elevated protein	UNK	UNK	Lisinopril		an antecedent URI	~ ()~~~In patient		1						1	CSF test abnormal; Guillain-Barre syndrome; Hyporeflexia; Inappropriate antidiuretic hormone secretion; Myasthenic syndrome; Paraesthesia; Paralysis; Ventricular tachycardia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0048704	01/05/1993	ID	31.0	31		F	11/27/1992	3 days p/flu vax devel stiff, achy  knee pain worsened w/bending-2day later shoulders achy & stiff w/inability to use rt arm;									Y	11/06/1992	11/09/1992	3	NONE	UNK	UNK	NONE	NONE	hayfever	~ ()~~~In patient	ID92078	1						1	Arthralgia; Arthropathy; Hypokinesia	FLUX~PFIZER\WYETH~3928231~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0048706	01/05/1993	ID	30.0	30		F	12/07/1992	arm swelling from shoulder to fingers (lt) required removing rings; throbbing, inc heat @ site & red bump @ site; elevated arm & applied cold packs; able to use arm & hands;									Y	12/02/1992	12/03/1992	1	NONE	PUB	PUB	Oral contraceptives	NONE	erythromycin	NA~ ()~~~In patient	ID92080	1						1	Injection site hypersensitivity; Injection site pain; Oedema peripheral; Vasodilatation	FLUX~PFIZER\WYETH~4928231~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0048709	01/05/1993	MA	53.0			F		Guillain-Barre synd, paralysis, currently on ventilator;					Y					11/04/1992	11/18/1992	14		UNK	UNK	Seldane, Cogentin, prodixin, Tegretol, Grisiofulvin		sz disorder unchanged on CT Scan, chronic schizophrenia	~ ()~~~In patient		1						1	Guillain-Barre syndrome; Paralysis	FLUX~PFIZER\WYETH~4928230~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0048715	01/06/1993	IL	29.0	29		F	11/16/1992	c/o throat closing off & wheezing w/SOB;				Y	Y	1			Y	11/09/1992	11/09/1992	0		OTH	PVT		NONE	NONE	~ ()~~~In patient	IL92119	1						1	Asthma; Dyspnoea; Laryngospasm	FLUX~PFIZER\WYETH~3928215~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0048717	01/06/1993	TX	69.0	69		F	11/26/1992	local reaction @ inject site; pain, swelling, warmth radiating under arm to breast up into neck;				Y					Y	10/20/1992	10/20/1992	0	NA	PUB	PUB	NA	NA	NA	NA~ ()~~~In patient	TX92256	1						1	Injection site oedema; Injection site pain; Vasodilatation	FLUX~PFIZER\WYETH~4928241~UNK~SC~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048718	01/06/1993	TX	52.0	52		F	12/21/1992	pt recvd vax 16NOV92 & flu sx 18NOV92, numbness in feet 19NOV92; numbness knees & difficulty to speak & swallow 20NOV92 dx;			Y	Y	Y		Y		U	11/16/1992	11/19/1992	3	guillain-Barre synd	PUB	PUB			back problems	NONE~ ()~~~In patient	TX92257	1						1	Dysphagia; Guillain-Barre syndrome; Influenza; Paraesthesia; Speech disorder	FLUX~PFIZER\WYETH~4928285~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~CONNAUGHT LABORATORIES~2D41066~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0046716	01/07/1993	PA	60.0	60		M	10/15/1992	pt recvd flu vax 1OCT92; 10OCT92 pt suffered a cardiac arrest; pt found in ventricular fibrillation; adm to hosp w/pulmonary edema; MD feel cardiac arrest was the result of cardiomyopathy;					Y				Y	10/01/1992	10/10/1992	9		PVT	PVT	Amiodarone, Zantac, Lanoxin, Capoten, Coumadin, Lasix, Potassium Chloride, Xanax, Zaroxolyn, Halcion, Mevacor;		pt has haad viral cardiomyopathy for 5 yrs; pt is awaiting a heart transplant;	~ ()~~~In patient	892289003E	1						2	Cardiac arrest; Condition aggravated; Pulmonary oedema; Ventricular fibrillation	FLUX~PFIZER\WYETH~4928130~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0048723	01/07/1993	NY	82.0			F	11/11/1992	pt recvd flu vax & 8 days later exp a change in mental status characterized as confusion & severe agitation; CBC, SMA, Urine, culture & sensitivity, x-rays were unrevealing; episode attributed to dementia;					Y				N	10/28/1992	11/06/1992	9	CBC, SMA, Urine c&s, x-rays were unrevealing;	PVT	PVT	unk	post-urosepsis	poss alzheimer's disease, Urosepsis	~ ()~~~In patient	892328014K	1						1	Agitation; Confusional state; Dementia	FLUX~PFIZER\WYETH~4928135~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0048724	01/07/1993	AZ	65.0	65		M	12/02/1992	pt recvd flu vax; pt states inject was given directly into ax nerve; pt exp instant severe pain that has persisted over 8 wks; atrophy of the posterior deltoid & impaired function & persistent pain in the lt deltoid & trapezius; poss GBS;								Y	N	10/19/1992	10/19/1992	0	EMG, nerve conduction velocities, MRI of brain; (specific results unknown);	PVT	OTH	none specified;	NONE	NONE	NONE~ ()~~~In patient	892339002E	1						1	Coordination abnormal; Guillain-Barre syndrome; Hypokinesia; Muscle atrophy; Myalgia; Neuritis; Pain	FLUX~PFIZER\WYETH~4928228~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0048728	01/07/1993	MS	61.0	61		M	12/11/1992	lt arm red & warm; VS 99.2-88-18, BP 146/92; red & itching; pt had some temp in area site & redness & itching;				Y					U	12/10/1992	12/10/1992	0		PUB	UNK	Verlin, Hema	NONE	NONE	~ ()~~~In patient	MS9267	1						1	Pruritus; Pyrexia; Vasodilatation	FLUX~PFIZER\WYETH~4928149~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~334957~UNK~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0048737	01/08/1993	NY	65.0	65		F	11/19/1992	extreme pain in neck, down arm during shot; became nauseous & dizzy; sore arm & neck for about 5 days;									Y	11/09/1992	11/09/1992	0		PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	NYS92077	1						1	Dizziness; Myalgia; Nausea; Neck pain; Pain	FLU3~PARKE-DAVIS~01872P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0048741	01/08/1993	OH	32.0	32		F	10/27/1992	pt states has had the flu vax a/ w/o any reaction;  this time approx 48 hrs p/recvd vax devel rash w/swelling on ankles, thighs, wrists, & neck; seen by MD;				Y					Y	10/20/1992	10/22/1992	2		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	OH92094	1						1	Oedema; Oedema peripheral; Osteoarthritis; Rash	FLUX~PFIZER\WYETH~4928244~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048755	01/08/1993	VT	59.0	59		M	12/14/1992	pt descrives onset of redness @ inject site, LD w/rash occuring & spread to forearms, shoulder, chest, groins; denies fever or rash on face, no resp distress, no neuro deficit; rash described as, prickly, raised, dry, rough & itchy;				Y					Y	10/23/1992	10/24/1992	1		PUB	PVT	HTN med, Cardigem CD	leg wound-resulting from boiling H20		~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~2F31117~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0048756	01/08/1993	MN	15.0	15		M	12/31/1992	8 days p/receiving vax pt had generalized tonic clonic seizure; seen by MD; hx febriel seizure; pt recvd 1st & 2nd doses of vax 20OCT92 & 17DEC92;				Y					Y	12/17/1992	12/25/1992	8	liver function test, CBC, electrolytes;	UNK	UNK	Theophylline	NONE	devel delay, hx febrile seizure in past;	pt exp sz @ 14 yrs w/Recombivax/Fluzone #1 dose;~ ()~~0.00~Patient		1						1	Condition aggravated; Convulsion; Condition aggravated; Convulsion; Grand mal convulsion	HEP~MERCK & CO. INC.~1257V~2~~~HEP B (RECOMBIVAX HB)~1|FLU3~CONNAUGHT LABORATORIES~2F31143~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|HEP~MERCK & CO. INC.~1257V~2~IM~~HEP B (RECOMBIVAX HB)~2	USA	Emergency room visit	Influenza
0048803	01/11/1993	MO	71.0	71		M	12/30/1992	24OCT pt c/o aching all over, joints hurt; no elevated temp; on 24NOV to ER dx pneumonia, rt lung, spit up blood several times;									U	10/19/1992	10/24/1992	5		PUB	PUB		NONE		~ ()~~~In patient	MO93001	1						1	Arthralgia; Haemoptysis; Myalgia; Pneumonia	FLU3~PARKE-DAVIS~01772P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0048810	01/11/1993	OR	43.0	43		F	11/03/1992	c/o rt thigh swelling approx 2 circum x 3 days & leg stiffness; c/o shakes, chills, nausea, severe muscle ache, fever to 102; BP 80/40;										10/29/1992	10/29/1992	0		PUB	PUB	ASA, Methotrerate, Pred	NONE	Rheumatoid arthritis hx, freq bouts pneumonia; allergic to Cifurodine & Imipenn; Sarcoma of bone dx leg 86 splenectomy 88;	NONE~ ()~~~In patient	OR9263	1						1	Chills; Hypertonia; Hypotension; Injection site oedema; Myalgia; Nausea; Pyrexia; Tremor	FLUX~PFIZER\WYETH~4928231~UNK~~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~330949~2~~RL~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0048814	01/11/1993	OR	62.0	61		F	11/05/1992	flu shot recvd on 26OCT; 28OCT lt arm became achy-shoulder to wrist & up into neck; c/o some tingling also; no redness or swelling reported; no fever;									U	10/26/1992	10/28/1992	2		PUB	PUB	Premarin	sinus infection-Amoxicillin	arthritis	~ ()~~~In patient	OR9267	1						1	Arthralgia; Myalgia; Neck pain; Paraesthesia	FLUX~PFIZER\WYETH~4928231~5~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0048815	01/11/1993	OR	33.0	33		F	11/23/1992	17NOV92 pt had sweats, woke up w/sore neck & 1/2 nodule present near clavicle; sharp pain in lt neck area, numbness lt neck face & lt arm; went to ER for help; 20NOV nodules appeared on lt lymph area @ neck; inc weakness & h/a;				Y					U	11/12/1992	11/17/1992	5		PUB	PUB	on birth control pills	NONE	hay fever in summer; no allergy to meds;	NONE~ ()~~~In patient	OR9268	1						1	Asthenia; Headache; Hyperhidrosis; Lymphadenopathy; Neck pain; Paraesthesia	FLUX~PFIZER\WYETH~4928231~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048817	01/11/1993	OR	41.0	41		F	11/23/1992	about 10 hrs p/receiving flu vax exp nausea & severe dizziness lasting approx 24 hrs seen by MD 13NOV92;				Y					Y	11/12/1992	11/12/1992	0	NONE	PUB	PUB		NONE	chemical sensitivities-perfumes, cigarette smoke, formaldehyde-petroleum products	~ ()~~~In patient	OR9274	1						1	Dizziness; Nausea	FLUX~PFIZER\WYETH~W4928216~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048819	01/11/1993	OR	17.0	17		M	12/14/1992	Pt recvd vax & passed out to floor; BP 70/; no c/o h/a-seen by MD-given exam-no adverse findings; syncope following inject;				Y					Y	12/14/1992	12/14/1992	0		PUB	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	OR9276	1						1	Hypotension; Syncope	FLU3~CONNAUGHT LABORATORIES~2F31098~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~1H31128~6~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048824	01/11/1993	SC	41.0	41		F	11/04/1992	3NOV92 took flu shot 7PM had temp 99.8, diaphoresis, shaking, chills & muscle aches; site of inject very tender; unusual stinging when med injected;									Y	11/03/1992	11/03/1992	0	NA	PUB	PUB		NONE	numerous allergies-chronic bronchitis	~ ()~~~In patient	SC92136	1						1	Chills; Hyperhidrosis; Injection site pain; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~2F31171~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0048837	01/11/1993	CT	60.0	60		F	01/05/1993	bronchitis, inflamed sternum, pains & swelling in joints of hands knees & toes severe rheumatoid arthritis; reaction started p/flu shot;			Y	Y				Y	N	11/06/1991	11/20/1991	14	bone scan & blood test pos;	PUB	UNK		NONE	NONE	~ ()~~~In patient		1						1	Arthralgia; Bronchitis; Osteoarthritis; Rheumatoid arthritis	FLU3~LEDERLE LABORATORIES~312973~1~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Life Threatening,Disabling	Influenza
0049045	01/13/1993	PA	69.0			M		pt exp diplopia & frontal h/a 1 day p/receiving flu vax followed by diminished visual acuity in lt eye & lt ptosis; poss GBS;					Y			Y		11/06/1992	11/06/1992	0	CSF-appearance was transparent & acellular present material neg for malignant cells;	UNK	UNK	Ecotrin, Tagamet		Gastroesophageal reflux dis, hypercholesterolemia, hx of anxiety disorder, stable abdo aortic aneurysm;	~ ()~~~In patient		1						1	Diplopia; Eyelid ptosis; Guillain-Barre syndrome; Headache; Visual disturbance	FLUX~PFIZER\WYETH~4928217~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0049051	01/13/1993	FL	59.0	59		F	12/24/1992	w/in 15-20 mins p/inject, pt had swollen eyes, tearing, red-sneezing-face became red; no dyspnea, itched all over;				Y					Y	11/30/1992	11/30/1992	0		PUB	PUB	NONE		allergic to Heptavax-vax;	pt exp severe GI problems @ 50 y/o w/Heptavax;~ ()~~~In patient	FL92075	1						1	Face oedema; Lacrimal disorder; Pruritus; Rhinitis; Vasodilatation	FLU3~PARKE-DAVIS~0182P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0049057	01/14/1993	CA	68.0	68		F	11/23/1992	pt recvd flu vax & 1 mo later, devel rash, cough, pleuritic chest pain & an inflitrate was seen on cxr; found to have vasculitis; tx w/steroids; pt died; autopsy is pending;	Y				Y	26			N	10/21/1992	11/07/1992	17	cocci latex test was pos;	OTH	OTH	Hypertension meds	unk	unk	~ ()~~~In patient	892343002K	1						1	Arthralgia; Coagulopathy; Condition aggravated; Haemorrhage; Leukocytosis; Pleural effusion; Sepsis; Vascular occlusion	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0049059	01/14/1993	MA	55.0	55		F	12/11/1992	20OCT lt & rt handed pins & needles w/pain & was intermittent; 27OCT inc pain & swelling sought medical attention 28OCT92; lab work nl; states pt wears braces to bed nightly; redness, swelling, pins & needles, pain in finger nails to touch;				Y					N	10/08/1992	10/20/1992	12	lab work nl;	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MA9229	1						1	Insomnia; Oedema; Pain; Paraesthesia; Vasodilatation; Oedema; Pain; Paraesthesia; Arthralgia; Oedema; Pain; Paraesthesia	FLUX~PFIZER\WYETH~4928230~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0455V~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|MMR~MERCK & CO. INC.~0455V~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~2|FLUX~PFIZER\WYETH~4928230~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|MMR~MERCK & CO. INC.~0455V~1~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~3	USA	Emergency room visit	Influenza
0049066	01/15/1993	MD	73.0	73		M	11/18/1992	vomiting, fever 101, body aches;									Y	11/12/1992	11/18/1992	6	NONE	PUB	PUB	unk	NONE	cardiac bypass- 2 yrs ago & hypertension	NONE~ ()~~~In patient	MD92086	1						1	Myalgia; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~01572P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0049067	01/15/1993	MD	73.0	73		F	10/28/1992	25OCT92 achiness, no temp; 26OCT92 sore throat;									Y	10/23/1992	10/25/1992	2	NONE	PUB	PUB	UNK	unk	unk	NONE~ ()~~~In patient	MD92087	1						1	Myalgia; Pharyngitis	FLU3~PARKE-DAVIS~01572P~3~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0049068	01/15/1993	MD	62.0	62		F	10/28/1992	localized redness, hot & inflammed site of infect (rt arm); no fever; itching & burning;									Y	10/07/1992	10/08/1992	1	NA	PUB	PUB	UNK	NONE	NONE	NONE~ ()~~~In patient	MD92088	1						1	Injection site hypersensitivity; Injection site inflammation; Pain; Pruritus; Vasodilatation	FLU3~PARKE-DAVIS~01572P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0049086	01/15/1993	MA	72.0	72		M	01/07/1993	aches, pain, chills, t99 day of vax; taste in mouth different; sent to ER; body hot-face burning lasting 2 hrs everyday;				Y					N	10/06/1992	10/11/1992	5	BC;	UNK	PUB	Tegritol-Phenobarbital, Valium, Vancenase	NONE		~ ()~~~In patient	MA9301	1						1	Chills; Dysgeusia; Myalgia; Pain; Pyrexia; Vasodilatation; Chills; Dysgeusia; Myalgia; Pain; Pyrexia	FLUX~PFIZER\WYETH~4928222~7+~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928222~7+~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0049091	01/19/1993	MI				M	12/31/1992	pt recvd flu vax & 3 wks later devel viral encephalitis & was hospitalized;					Y				U					OTH	OTH	UNK			~ ()~~~In patient	893006002E	1						1	Encephalitis; Infection	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0049094	01/19/1993	ID	60.0	60		M		30NOV92 recvd flu vax; 10DEC92 Bell's Palsey;										11/30/1992	12/10/1992	10	NONE	PVT	PVT	Maxain	NONE		pt exp lt 6th nerve paresis in NOV91 w/flu vax @ 59 y/o;~ ()~~~In patient	ID93002	1						1	Facial palsy	FLU3~CONNAUGHT LABORATORIES~2F31143~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049101	01/19/1993	CO	58.0	58		M	01/08/1993	pt recvd flu vax 12NOV92 & was adm to hosp on 23NOV92 p/developing SOB, diaphoresis; also c/o tingling, weakness; pt collapsing @ home; dx w/GBS 27NOV92;				Y	Y	760			U	11/12/1992	11/23/1992	11	sed rate 2 27NOV92; all stregnth dec; deltoid 4.5, tricep 4, bic 4; CPK 540 23NOV92; grp 4 sr, 4.0L, et deep tendon ref dec;	OTH	PVT	NONE	hearin loss APR92 rt ear	long standing, rt ear hearing loss	~ ()~~~In patient		1						1	Asthenia; Blood creatine phosphokinase increased; Dyspnoea; Guillain-Barre syndrome; Hyporeflexia; Myasthenic syndrome; Paraesthesia; Syncope	FLUX~PFIZER\WYETH~4928224~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0049103	01/19/1993	WV	71.0	71		M	01/14/1993	numbness & weakness of lt face, arm, leg & chest pressure lasting 30 sec to 2 mins (10-30 times/day); no improvement on ASA, ticlid, phenytoin, phenobarbital, procardia;				Y	Y	9			N	10/20/1992	10/30/1992	10	24 hr EEG-WNL; carotid angiography-WNL; Ct head-WNL; MRI head-WNL; coronary angiography neg;	PUB	PUB	DPH	excellent	allergies-cats, food preservatives	pt exp hyperactivity @ 66 w/influenza;~ ()~~~In patient	WV9302	1						1	Chest pain; Myasthenic syndrome; Paraesthesia	FLU3~PARKE-DAVIS~0182P~6~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0049115	01/19/1993	PA	69.0	69		F	01/12/1993	severe muscle weakness & pain to upper extremities; no strength in both hands; couldn't lift anything-couldn't dress self-couldn't drive;				Y					Y	10/22/1992	11/01/1992	10	C1 esterase inhibitor 32.2; glucose134H; BUN/crea 22.5H; GLobulin 4.0H; MCH-26.9L; MPV-6.6L; sed rate-42H; sed rate (westergren) 44HI;	PVT	PVT		NONE	degenerative arthritis rt hip	~ ()~~~In patient		1						1	Blood urea increased; Globulins increased; Hyperglycaemia; Laboratory test abnormal; Myalgia; Myasthenic syndrome; Red blood cell sedimentation rate increased	FLU3~LEDERLE LABORATORIES~337934~1~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0049124	01/19/1993	IL	77.0	77		M	01/04/1993	pt c/o fatigue, loss of appetite p/flu vax on 15NOV92; sx lasted about 8-9 days;									Y	11/15/1992			14DEC92 FBS=135 mg/dL;	MIL	PUB	Glipizide 2.5 mg		MIDDM	~ ()~~~In patient		1						1	Anorexia; Asthenia; Hyperglycaemia	FLUX~PFIZER\WYETH~4928203~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0049125	01/19/1993	IL	69.0	69		M	01/11/1993	SOB, aches p/flu shot; thickening of phlegm, unable to cough up phlegm-lasted approx 2 wks p/shot;									Y	11/02/1992	11/03/1992	1		OTH	PUB	Glipizide, Digoxin, Isordil, Ceptopil, Lasix;	NONE	Cardiomyopathy, COPD	~ ()~~~In patient		1						1	Dyspnoea; Myalgia; Salivary hypersecretion	FLUX~PFIZER\WYETH~4928203~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0049127	01/19/1993	IL	67.0	67		M	01/07/1993	inc SOB, inc in thickness of sputum approx 6-8 hrs p/flu vax;									Y	12/14/1992	12/14/1992	0		OTH	PUB	Procardia, alupent inhaler	cold	COPD, HTN	~ ()~~~In patient		1						1	Dyspnoea	FLUX~PFIZER\WYETH~4928208~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0049129	01/20/1993	CA	58.0	58		F	11/11/1992	nausea & diarrhea;										11/03/1992	11/03/1992	0		PVT	PVT		NONE		~ ()~~~In patient		1						1	Diarrhoea; Nausea	FLU3~PARKE-DAVIS~00292P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0049130	01/20/1993	CA	59.0	59		M	11/11/1992	nausea, diarrhea;									Y	11/03/1992	11/03/1992	0		PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Diarrhoea; Nausea	FLU3~PARKE-DAVIS~00292P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0049208	01/21/1993	FL				F		pt smelled a burnt smell & had a dry cough; pt had recvd flu & pneumonia shots;										02/14/1992	02/14/1992	0		UNK	UNK	Catapress, Clonidine Hydrochloride, Voltaren		arhtritis, pt had altered smell while taking calan, hypertension; D/C 14FEB92;	~ ()~~~In patient	MCA0325921	1						1	Cough; Parosmia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0049211	01/21/1993	CA	64.0	64		F	12/01/1992	23NOV chills, HA, general malaise seen by MD who prescribed Amoxil; had sem reaction to prev flu shot;				Y					Y	11/17/1992	11/23/1992	6		PUB	PUB	NONE	NONE		pt exp chills, h/a, malalise w/ flu shot #1;~ ()~~~In patient	CA92169	1						1	Chills; Headache; Malaise	FLUX~PFIZER\WYETH~4928219~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0049212	01/21/1993	CA	30.0	30		M	11/20/1992	20NOV woke up w/puffiness around the eyes, scratchiness in ear sinus probably; has had sinus problems itchy spots on both arms; advised to see MD for resp problems & worsening of present sx;									U	11/17/1992	11/20/1992	3		PUB	PUB		NONE	sinus problems	~ ()~~~In patient	CA92170	1						1	Condition aggravated; Ear disorder; Face oedema; Pruritus; Rash	FLUX~PFIZER\WYETH~4928219~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0049213	01/21/1993	CA	85.0	85		M	11/17/1992	7NOV92 weakness on lt side where vax given arm, leg & lt side of head; also c/o h/a; seen by MD 11NOV;									Y	11/05/1992	11/07/1992	2	NONE	PUB	PUB	Lasix	NONE	NONE	~ ()~~~In patient	CA92171	1						1	Headache; Myasthenic syndrome	FLUX~PFIZER\WYETH~4928219~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0049214	01/21/1993	CA	62.0	62		F	11/09/1992	redness, swelling & itching @ site of inject;									Y	11/05/1992	11/06/1992	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	CA92172	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLUX~PFIZER\WYETH~4928219~5~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0049220	01/21/1993	CA	64.0	64		F	11/13/1992	pt given vax rt deltoid inflammation the size of silver dollar, 2 days p/vax redness & pain through whole arm; spread visually from deltoid to past elbow; swelling, hot to touch, unable to lift, applied ice 2 days later had a black blister				Y						10/15/1992	10/17/1992	2		PUB	PUB			legally blind-glaucoma & macular degeneration, heart trouble	NONE~ ()~~~In patient	CA92178	1						1	Dermatitis bullous; Hypokinesia; Injection site inflammation; Oedema; Pain; Vasodilatation	FLUX~PFIZER\WYETH~4928219~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~314913~2~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0049280	01/22/1993	MA	79.0	79		M	12/28/1992	headache;									Y	10/16/1992	10/16/1992	0		PUB	PUB				~ ()~~~In patient	MA9303	1						1	Headache; Headache	FLUX~PFIZER\WYETH~4928221~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928221~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0049281	01/22/1993	MA	39.0	39		F	11/01/1992	burning throat, coughing up phlem, nasal congestion, watering eyes over about 5 days;									Y	10/15/1992	10/16/1992	1		PUB	PUB			high blood pressure, arthritis, back spasms	~ ()~~~In patient	MA9304	1						1	Cough; Lacrimal disorder; Pharyngitis; Rhinitis; Cough; Lacrimal disorder; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4928227~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928227~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0049282	01/22/1993	MA	41.0	41		F	12/08/1992	localized skin reaction-large reddened area around inject site (approx size of large orange) warm to touch; also reported feeling sl dizzy p/shot									Y	12/02/1992	12/02/1992	0	NA	OTH	PUB	NONE	sl dizziness p/vax	NONE	NONE~ ()~~~In patient	MA9305	1						1	Dizziness; Injection site hypersensitivity; Vasodilatation; Dizziness; Injection site hypersensitivity; Vasodilatation	FLUX~PFIZER\WYETH~4928235~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928235~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0049283	01/22/1993	NH	56.0	55		F	01/05/1993	pain upon inject (stinging pain) followed by warm erythma area 1 circular, lasting 4 days; no fever;									Y	11/26/1992	11/26/1992	0		OTH	PUB		NONE	osteoarthritis	~ ()~~~In patient	MA9306	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation; Injection site hypersensitivity; Injection site pain; Vasodilatation	FLUX~PFIZER\WYETH~0008081501~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0049288	01/22/1993	TN	37.0	37		M	01/12/1993	25NOV92 sx purpura, petechiae, epistaxis, bleeding gingivae 27NOV-30NOV testing, dx immune (idiopathic) thrombocytopenic purpura (ITP); tx Pred appears non-responsive;			Y	Y	Y			Y	N	11/04/1992	11/25/1992	21	platelet count 10 27NOV92; bone marrow biopsy; liver/spleen scan-nl; bleed time-failed;	OTH	OTH	NONE	NONE	allergy-poison ivy, medical condition-vitiligo	NONE~ ()~~~In patient		1						1	Epistaxis; Gingival bleeding; Petechiae; Purpura; Thrombocytopenia; Thrombocytopenic purpura	FLUX~PFIZER\WYETH~4928166~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0049290	01/22/1993	MA	79.0	79		F	10/22/1992	pt exp SOB, hyperventilation, dizzy, diarrhea, cramps, fingers tingling, allergic event;					Y	5				10/21/1992	10/22/1992	1		PUB	PUB				~ ()~~~In patient	MA9307	1						1	Colitis; Diarrhoea; Dizziness; Dyspnoea; Hypersensitivity; Hyperventilation; Pain; Paraesthesia; Diarrhoea; Dizziness; Dyspnoea; Gastrointestinal haemorrhage; Hyperventilation; Pain; Paraesthesia	FLUX~PFIZER\WYETH~4928230~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~334957~1~IM A~~PNEUMO (PNU-IMUNE)~1|FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~PFIZER\WYETH~334957~1~IM A~~PNEUMO (PNU-IMUNE)~2	USA	Hospitalisation	Influenza
0049319	01/25/1993	WA	65.0	65		F	12/02/1992	pt recvd vax 20NOV92 & became ill that noc; t101, arm sore & red, body ache;				Y					Y	11/20/1992	11/20/1992	0		PUB	PUB		NONE	bladder problems	~ ()~~~In patient	WA92805	1						1	Malaise; Myalgia; Pain; Pyrexia; Vasodilatation	FLUX~PFIZER\WYETH~4928231~5~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~3081909~UNK~SC~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0049320	01/25/1993	WA	50.0	49		F	12/02/1992	aching all fingers, shoulders, both hands w/tingling in both hands; @ site had itching & erythema as large as hand;				Y					Y	11/04/1992	11/05/1992	1		PUB	OTH	NONE	NONE	sulfa drugs	pt's son allergic to tetanus 20 yrs ago;~ ()~~~In patient	WA92806	1						1	Injection site hypersensitivity; Myalgia; Paraesthesia; Pruritus	FLUX~PFIZER\WYETH~4928231~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~CONNAUGHT LABORATORIES~2D41066~2~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0049324	01/25/1993	WA	54.0	54		F	12/10/1992	started 21NOV til 25NOV w/watery diarrhea, headache, ache all over, queasy stomach, general malaise;									Y	10/27/1992	11/21/1992	25	NONE	OTH	PVT		NONE	NONE	~ ()~~~In patient	WA92810	1						1	Diarrhoea; Headache; Malaise; Myalgia; Nausea	FLU3~CONNAUGHT LABORATORIES~2F31132~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049325	01/25/1993	WA	54.0	53		F	12/10/1992	felt tired, rundown-queasy stomach, next day felt great;									Y	10/27/1992	10/27/1992	0		OTH	PVT		NONE	NONE	~ ()~~~In patient	WA92811	1						1	Asthenia; Nausea	FLU3~CONNAUGHT LABORATORIES~2F31132~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049326	01/25/1993	WA	51.0	51		F	12/10/1992	weakness for about 24 hrs;									Y	11/02/1992			NONE	OTH	PVT		NONE	NONE	~ ()~~~In patient	WA92812	1						1	Asthenia	FLU3~CONNAUGHT LABORATORIES~2F31132~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049327	01/25/1993	WA	43.0	43		F	12/10/1992	felt lighheaded/dizzy, spacey & severe fatigue approx 1 wk p/shot & sx lasted for 10-12 days;									Y	10/27/1992	11/03/1992	7	NONE	OTH	PVT		NONE	NONE	~ ()~~~In patient	WA92813	1						1	Asthenia; Depersonalisation; Dizziness	FLU3~CONNAUGHT LABORATORIES~2F31132~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049328	01/25/1993	WA	41.0	41		F	12/10/1992	general malaise, fatigue x 24 hrs;									Y	11/10/1992	11/11/1992	1	NONE	OTH	PVT		NONE	NONE	~ ()~~~In patient	WA92814	1						1	Asthenia; Malaise	FLU3~CONNAUGHT LABORATORIES~2F31132~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049329	01/25/1993	WA	38.0	38		F	12/10/1992	cough, chills which escalated rapidly to full blown flu-i.e. fever, painful aching joints & URI;									Y	10/27/1992	10/27/1992	0	NONE	OTH	PVT		NONE	NONE	~ ()~~~In patient	WA92815	1						1	Arthralgia; Chills; Cough; Influenza; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~2F31132~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049330	01/25/1993	WA	53.0	53		F	12/10/1992	h/a & nausea x 1 day;									Y	11/04/1992	11/05/1992	1	NONE	OTH	PVT		NONE	NONE	~ ()~~~In patient	WA92816	1						1	Headache; Nausea	FLU3~CONNAUGHT LABORATORIES~2F31132~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049331	01/25/1993	WA	32.0	32		F	12/10/1992	dizziness, mild nausea & tired for 2 days;									Y	11/20/1992	11/21/1992	1		OTH	PVT		NONE	NONE	~ ()~~~In patient	WA92817	1						1	Asthenia; Dizziness; Nausea	FLU3~CONNAUGHT LABORATORIES~2F31132~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049332	01/25/1993	WA	48.0	48		F	12/10/1992	pain across mid-back & h/a; want to bed @ 630PM & felt ok by next AM;									Y	11/03/1992	11/03/1992	0		OTH	PVT				~ ()~~~In patient	WA92818	1						1	Back pain; Headache	FLU3~CONNAUGHT LABORATORIES~2F31132~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049333	01/25/1993	WA	57.0	57		F	12/10/1992	mild malaise w/in 1st 24 hrs;									Y	10/20/1992	10/20/1992	0	NONE	OTH	PVT				~ ()~~~In patient	WA92819	1						1	Malaise	FLU3~CONNAUGHT LABORATORIES~2F31132~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049334	01/25/1993	WA	49.0	49		F	12/10/1992	swollen & sore arm x 5 days;									Y	10/19/1992			NONE	OTH	PVT				~ ()~~~In patient	WA92820	1						1	Myalgia; Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~2F31132~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049335	01/25/1993	WA	44.0	44		F	12/10/1992	sl sore throat by end of day 20OCT; missed next 2 day of work due to aches & pains & extreme tiredness;									Y	10/20/1992	10/20/1992	0	NONE	OTH	PVT	UNK			~ ()~~~In patient	WA92821	1						1	Asthenia; Myalgia; Pain; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~2F31132~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049336	01/25/1993	WA	71.0	71		F	12/10/1992	aching all over; malaise;									Y	10/16/1992				OTH	PVT				~ ()~~~In patient	WA92822	1						1	Malaise; Myalgia	FLU3~CONNAUGHT LABORATORIES~2F31132~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049337	01/25/1993	WA	70.0	70		F	12/10/1992	whole body ached for several days;									Y	10/16/1992			NONE	OTH	PVT				~ ()~~~In patient	WA92823	1						1	Myalgia	FLU3~CONNAUGHT LABORATORIES~2F31132~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0049339	01/25/1993	WA	85.0	85		F	12/07/1992	soreness rt deltoid area, immed redness, numbness & tingling of fingers rt hand;				Y					N	10/26/1992	10/26/1992	0	NONE	PUB	PUB	Diazide, Lanoxin	NONE	hypertension, antivert	NONE~ ()~~~In patient	WA92825	1						1	Myalgia; Pain; Paraesthesia; Vasodilatation	FLUX~PFIZER\WYETH~4928166~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0049341	01/25/1993	WA	55.0	55		F	11/17/1992	pt called in 17NOV92 stated had flu shot 13NOV92 state pneumococcal arm very sore, red, swollen w/swelling moving down to elbow; referred to family MD;										11/13/1992				PUB	UNK		quinidine, codeine		~ ()~~~In patient	WA92827	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~4928285~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~316926~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0049352	01/25/1993	WA	50.0	50		F	11/13/1992	3NOV92 pt states recvd Flu/Pneumonia 26OCT92; 48 hrs later exp head-leg-hand pains & chills; did not take temp-no thermometer; 3NOV92 states skin hurts to the bone & chest feels tight;				Y					U	10/26/1992	10/28/1992	2	UNK	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	WA93839	1						1	Chest pain; Chills; Headache; Pain	FLUX~PFIZER\WYETH~4928285~2~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~326920~UNK~~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0049355	01/25/1993	WA	24.0	24		F	11/23/1992	hives-inside arms, stomach, lower back-size of quarter (arms), stomach very tiny, all raised, itched; gone by next AM;									Y	11/20/1992	11/21/1992	1		PUB	UNK	NONE	earlier that wk getting over cold		~ ()~~~In patient	WA93842	1						1	Pruritus; Urticaria	FLUX~PFIZER\WYETH~4928243~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0049367	01/25/1993	WA	63.0	63		F	01/20/1993	swelling of the face & eyes, prickly rash on body (all over); lost the use of thigh muscles & arm muscles (biceps, loss of head hair (large amounts); tx started FEB92;				Y					N	10/22/1991	10/27/1991	5	muscle biopsy; dermatomyositis;	PVT	PVT		NONE		~ ()~~~In patient		1						1	Alopecia; Dermatomyositis; Face oedema; Hypokinesia; Rash	FLUX~PFIZER\WYETH~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0049474	01/27/1993	MA	67.0	67		F	12/24/1992	2 days p/shot aches & pain in joints, fever under 100, h/a, sinuses, discharge from nose & eyes-post nasal drip; MD prescribed 10 day of ATB;									Y	10/28/1992	10/30/1992	2		UNK	UNK				~ ()~~~In patient	MA9308	1						1	Arthralgia; Headache; Lacrimal disorder; Myalgia; Pyrexia; Rhinitis; Arthralgia; Headache; Pyrexia; Sinusitis	FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0049475	01/27/1993	MA	31.0			M	01/20/1993	sore arm pain;									Y					PUB	PUB				~ ()~~~In patient	MA9309	1						1	Pain	FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0049479	01/27/1993	RI	68.0	68		M	01/23/1993	gradual onset of swelling/pain in lt hand/esp MCP's/ pip joints) 2-3 days p/vax also in lt shoulder, & rt to lesser degree;				Y					U	11/01/1992	11/04/1992	3	Bone scan 23DEC92; inc uptake rt A-C joint, both wrists, MCP, IP joints;	PUB	OTH	Procardia, Primidone, Balproate	NONE	erythema multiforme p/Dilantin; hx HTN, COPD, sz;	NONE~ ()~~~In patient		1						1	Arthralgia; Oedema peripheral; Osteoarthritis; Pain	FLUX~UNKNOWN MANUFACTURER~~3~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0049501	01/29/1993	MD	80.0			F		pt exp nausea & vomiting, rectal bleeding, BUN inc & creatinine inc are reported in pt who recvd fluogen on 12NOV86; pt devel abdo pain; some rectal bleeding; partial paralytic ileus was noted;					Y					11/12/1986			Creatinine 4, up since admission to hosp, BUN 16, unchanged since admission; hematocrit 50, up from 45 on admission;	UNK	UNK				~ ()~~~In patient	18782	1						1	Blood creatinine increased; Blood urea increased; Ileus; Nausea; Rectal haemorrhage; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0049503	01/29/1993	MA	76.0	76		M	12/24/1992	on the same evening p/flu shot pt had sx of a cold (sore throat, runny nose); p/having a cold for about 10 days, pt devel sinus infection; MD prescribed ATB & pt was better p/3-4 days;				Y					Y	10/21/1992	10/21/1992	0		OTH	PUB				~ ()~~~In patient	MA9311	1						1	Pharyngitis; Rhinitis; Sinusitis; Pharyngitis; Rhinitis; Sinusitis	FLUX~PFIZER\WYETH~4928221~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928221~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0049507	01/29/1993	NY	10.0	10		M	01/25/1993	20NOV92 appeared irritable, fatigued; 21NOV92 sudden, acute swelling of one knee; 22NOV92 pain in knee, pain jaw, difficulty walking or opening mouth, neck pain, fever-seen in ER; 22NOV to 25JAN92 inc joint involvement, fever headaches;				Y					N	11/18/1992	11/21/1992	3	blood tests; urine tests; xrays; throat culture;	PVT	PVT	Beclovent	conjunctivitus	asthma	NONE~ ()~~~In patient		1						1	Arthralgia; Asthenia; Gait disturbance; Headache; Hypokinesia; Neck pain; Osteoarthritis; Pain; Arthralgia; Asthenia; Osteoarthritis; Pyrexia; Rash; Weight decreased	FLU3~LEDERLE LABORATORIES~337935~1~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|FLU3~LEDERLE LABORATORIES~049507~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~2	USA	Emergency room visit	Influenza
0049546	02/01/1993	GA	36.0	36		F	01/15/1993	pt recvd Tetanus Toxoid vax on 1OCT92 & 11NOV92 was hospitalized w/sx of meningitis or encephalitis; pt devel some paralysis & was thought to have GBS; pt still exp numbness in hands & legs, & bladder control problems;					Y	8			U	10/01/1992	11/01/1992	31		OTH	OTH				~ ()~~~In patient	893019001E	1						1	Guillain-Barre syndrome; Infection; Meningitis; Myelitis; Neuropathy; Paraesthesia; Paralysis; Thinking abnormal; CSF test abnormal; Guillain-Barre syndrome; Infection; Meningitis; Myelitis; Neuropathy; Paraesthesia; Post vaccination syndrome	FLUX~PFIZER\WYETH~4928236~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~MERCK & CO. INC.~1060V~1~~~HEP B (RECOMBIVAX HB)~1|TD~PFIZER\WYETH~4928053~UNK~IM A~~TD ADSORBED (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928236~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEP~MERCK & CO. INC.~1060V~1~IM~~HEP B (RECOMBIVAX HB)~2|TD~PFIZER\WYETH~4928053~UNK~IM~~TD ADSORBED (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0049571	02/01/1993	NJ	4.0	4		M	10/21/1992	fever 103 & rhinitis; no redness, swelling or warmth to inject site;				Y					Y	10/05/1992	10/06/1992	1		PVT	PVT		resolving asthmatic, bronchitis	asthma	~ ()~~~In patient		1						1	Pyrexia; Rhinitis	FLU3~LEDERLE LABORATORIES~337909~UNK~~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0049579	02/01/1993	NJ	6.0	6		M	11/02/1992	2-3 days p/vax pt devel t102 & became nauseated (lasted 1 noc); several nocs p/exp achiness, & stomache pains; no redness, swelling, or warmth to the inject site;									Y	10/27/1992	10/29/1992	2		PVT	PVT		NONE	asthma	~ ()~~~In patient		1						1	Abdominal pain; Myalgia; Nausea; Pyrexia	FLU3~LEDERLE LABORATORIES~337909~UNK~~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0049581	02/01/1993	MA	48.0	47		F	01/28/1993	8PM 17JAN93 sudden onset of nausea & dizziness w/ataxic gait; 9-10PM vomited 5x's then to bed; 18JAN93 mild nausea in AM & by noon felt 100% better;									Y	01/13/1993	01/17/1993	4	NONE	PVT	OTH	TB Skin test	NONE	NONE	~ ()~~~In patient		1						1	Coordination abnormal; Dizziness; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0049603	02/02/1993	MA	72.0			M	01/28/1993	4 days p/shot had sore throat constantly 3 wks later bad cold? which lingered on & on; this is 3rd yr exactly same thing happened;									U				NONE	PUB	UNK	NONE	NONE	Hypertension/allergies	pt exp sor throat & bad cold following vax; sibling also exp adverse rxn;~ ()~~~In patient	MA9318	1						1	Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4928230~4~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0049605	02/03/1993	MA	70.0	70		F	01/03/1993	severe stiffness & aching plus cold sx; could barely move arms & shoulders due to severe pain lasted over a wk;									Y	10/26/1992	10/26/1992	0		PUB	UNK				~ ()~~~In patient		1						1	Hypertonia; Hypokinesia; Myalgia; Pain; Pharyngitis; Rhinitis; Hypertonia; Myalgia; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0049780	02/03/1993	MN	10.0	10		M	10/14/1992	pt devel a severe sore throat & fever 104 p/receiving flu vax; pt was ill for 2 wks; Pt seen by MD  9NOV91 & dx w/viral tonsillitis;				Y					Y	10/15/1991	10/15/1991	0		PVT	OTH	UNK	NONE	pt underwent ciliary biopsy on 22NOV91; treated w/co-trimoxazole & devel a rash; has ectodermal dysplasia w/absent teeth, curly hair, dysmotile cilia synd & abn cilia on electron microscopy;	pt exp sore throat & fever @ 10 yrs old w/flu vax given 4NOV90;~ ()~~~In patient	892304002E	1						1	Infection; Pharyngitis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0049781	02/03/1993	WI	40.0			F	11/10/1992	pt recvd flu vax & exp itching around the site of inject;									Y				NONE	PVT	PVT	UNK		pt is allergic to tetracycline, sulfa, ludiomil, & Tylenol;	~ ()~~~In patient	892324003E	1						1	Pruritus	FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0049782	02/03/1993	IA	61.0	61		F	11/19/1992	pt devel heart palpitation w/in 24 hrs of receiving flu vax;									Y	11/22/1991	11/22/1991	0		PVT	PVT	Slow K, Glucotrol, Tenormin, Hygroton, Valium, Apresoline;			~ ()~~~In patient	892338003P	1						1	Palpitations	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0049783	02/03/1993	IA	70.0			M	11/20/1992	pt recvd flu vax & devel wheezing, coughing & excess phlegm; sx lasted approx 6 to 7 months, then cleared up;									Y					OTH	OTH	UNK			~ ()~~~In patient	892338012K	1						1	Asthma; Cough	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0049784	02/03/1993	OK				F	11/17/1992	pt recvd flu vax & the noc p/inject devel rash & sl inc in temp;									Y					OTH	OTH	Premarin, Xanax			~ ()~~~In patient	892343003K	1						1	Pyrexia; Rash	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0049675	02/04/1993	FL	70.0			M		lt side weakness & stroke are reported in pt who recvd fluogen;					Y					09/29/1986	09/30/1986	1		UNK	UNK				~ ()~~~In patient	19724	1						1	Cerebrovascular accident; Myasthenic syndrome	FLU3~PARKE-DAVIS~6366P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0049676	02/04/1993	NY	18.0			M		brainstem lesions are reported in pt who recvd fluogen vax; also had diplopia, ataxia w/wide based gait; pt's MRI showed 2 brainstem lesions;										12/12/1986	01/14/1987	33	MRI-2 brainstem lesions;	UNK	UNK				~ ()~~~In patient	19696	1						1	Coordination abnormal; Delirium; Diplopia; Gait disturbance	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0049677	02/04/1993	FL	84.0			M		sz are reported in pt who recvd vax; onset of sz devel 15 days p/was vaxed; hx of syncope;					Y					09/15/1986	09/30/1986	15	NS	UNK	UNK			prior hx of syncope	~ ()~~~In patient	19722	1						1	Convulsion	FLU3~PARKE-DAVIS~4086G070~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0049678	02/04/1993	AK	42.0	42		F	11/11/1992	23OCT92 several hrs p/flu shot pt was given pt had warmth & pain @ inject site & muscle cramps on entire lt side of body-joint pain cont for several days; 26OCT92 had asthma attack, wheezing; had kidney pain & earache;				Y						10/23/1992	10/23/1992	0	NONE	OTH	PUB	Salsalote & allerest	asthma (chronic); rheumatoid arthritis	allergies; asthma (chronic); Rhematoid arthritis (chronic) hearing loss;	unk~ ()~~~In patient	AK93001	1						1	Arthritis; Condition aggravated; Ear pain; Hypertonia; Injection site pain; Renal pain; Vasodilatation	FLUX~PFIZER\WYETH~4928285~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0049681	02/04/1993	FL	34.0	34		M	01/19/1993	area of inject hot red, swollen x 4 days; flu-like sx (low) fever, lethargy, muscle aches, nausea;									Y	12/09/1992	12/19/1992	10	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	FL9301	1						1	Influenza; Injection site hypersensitivity; Injection site oedema; Myalgia; Nausea; Pyrexia; Somnolence; Vasodilatation	FLU3~PARKE-DAVIS~01272P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|MMR~MERCK & CO. INC.~1755T~UNK~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0049683	02/04/1993	MA	59.0	59		M	01/25/1993	head cold w/cough, heaviness in chest; w/in 2-3 days, devel SOB, weakness, nearly collapsed @ home; to hosp via ambulance; dx acute bronchitis; readmitted 14DEC92 w/pulmonary embolus;				Y	Y	7	Y		Y	10/30/1992	11/05/1992	6	cxr; multiple blood tests;	OTH	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MA9315	1						1	Asthenia; Bronchitis; Chest pain; Cough; Dyspnoea; Pharyngitis; Pulmonary embolism; Rhinitis; Asthenia; Bronchitis; Chest pain; Cough; Dyspnoea; Pharyngitis; Pulmonary embolism; Rhinitis	FLUX~PFIZER\WYETH~4928230~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928230~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0049684	02/04/1993	MA	52.0	52		M	10/30/1992	w/in several hrs of vax, vomited x 1, lt work; never felt well but acutely ill w/minimal fatigue, chest heaviness, non-prod cough; seen by MD 6 wks later tx w/PCN; prob bronchitis & or pneumonia;				Y					Y	10/30/1992	10/30/1992	0	cxr-neg; urine, blood test ?type-all nl; TB test neg;	OTH	PUB	NONE	NONE	hx of repeated pneumonia & bronchitis	NONE~ ()~~~In patient	MA9316	1						1	Asthenia; Bronchitis; Chest pain; Condition aggravated; Cough; Malaise; Pneumonia; Vomiting; Asthenia; Bronchitis; Chest pain; Cough; Malaise; Pneumonia; Vomiting	FLUX~PFIZER\WYETH~4928230~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928230~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0048028	02/05/1993	MA	70.0	70		M	01/25/1993	pt recvd flu vax & the next day became overexerted; pt exp coughing & emesis; pt was seen in ER & adm to hosp; pt was discharged the following day;				Y	Y	1			Y	10/14/1992	10/15/1992	1	pt underwent workup for acute myocardial infarction including: EKG, Enzymes, stress test;	PUB	PUB			pt has heart problems-coronary artery disease;	~ ()~~~In patient	893026001E	1						2	Asthenia; Cough; Vomiting	FLUX~PFIZER\WYETH~4928280~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0049290	02/05/1993	MA	79.0			F	01/25/1993	pt recvd flu vax on 21OCT92 & the next day exp hyperventilation, accompanied by SOB, diarrhea, cramps, dizziness & tingling in fingers; pt adm to hosp; also lower gastrointestinal bleeding; MD felt vax unrelated to illness;					Y	5			U	10/21/1992	10/22/1992	1	pt underwent Colonoscopy which demonstrated lower gastrointestinal bleeding;	PUB	PUB	Advil		pt has hx of osteoarthritis, & reported that had been taking 6 Advil tablets daily for 3 wks prior to hosp admission;	~ ()~~~In patient	893026002E	1						2	Colitis; Diarrhoea; Dizziness; Dyspnoea; Hypersensitivity; Hyperventilation; Pain; Paraesthesia; Diarrhoea; Dizziness; Dyspnoea; Gastrointestinal haemorrhage; Hyperventilation; Pain; Paraesthesia	FLUX~PFIZER\WYETH~4928230~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~334957~1~IM A~~PNEUMO (PNU-IMUNE)~1|FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~PFIZER\WYETH~334957~1~IM A~~PNEUMO (PNU-IMUNE)~2	USA	Hospitalisation	Influenza
0049696	02/08/1993	FL	76.0			M		attempted suicide & psychosis are reported in a pt who recvd flu vax; 3 days prior to the development of psychosis pt attempted suicide w/2 bottles of antidepressant; pt had recvd flu vax approx 2 wks prior to these events;														UNK	UNK				~ ()~~~In patient	19719	1						1	Psychotic disorder; Suicide attempt	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0049704	02/08/1993	GA	62.0	62		F	12/22/1992	On 8NOV92 pt became fever of over 104 & lower part of back aching, weak & sick @ stomach; went to MD had bad kidney infection w/bacteria & blood in kidney;			Y	Y					Y	10/27/1992	11/08/1992	12		PUB	PUB				~ ()~~~In patient	GA92246	1						1	Asthenia; Back pain; Dyspepsia; Pyrexia; Urinary tract infection	FLUX~PFIZER\WYETH~4928233~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0049710	02/08/1993	MA	86.0	86		F	01/04/1993	red rash lasted 1 wk;									Y	10/01/1992	10/01/1992	0		PUB	PUB		NONE		~ ()~~~In patient	MA9317	1						1	Rash; Rash	FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4923230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0049731	02/08/1993	UT	81.0	81		F	02/01/1993	couldn't get out of bed in morning due to pain-all over body weakness (extreme)-not in joints-just muscles; lt leg & ankle started to swell 2 to 3 wks, rt hand swelled a little; had cont pain in muscles;				Y					N	10/09/1992	10/11/1992	2	blood tests;	PUB	PVT	NONE	NONE	hayfever	~ ()~~~In patient	UT932501	1						1	Asthenia; Myalgia; Myasthenic syndrome; Oedema peripheral; Pain; Arthritis; Hypokinesia; Myalgia; Osteoarthritis	FLUX~PFIZER\WYETH~4928224~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928224~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0049739	02/08/1993	CO	38.0			F	11/23/1992	pt had flu shot 830AM-850 presented to clinic w/ c/o filling up; no SOB but hoarseness & drainage from nose/sinus; no stridor, no swelling,  lung CTA; given DPH;				Y					Y	11/09/1992	11/09/1992	0	NA	OTH	PVT	NONE	NONE		~ ()~~~In patient		1						1	Dysphonia; Rhinitis	FLUX~PFIZER\WYETH~4928224~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0049740	02/08/1993	OK	33.0	33		F	01/25/1993	flushing, near syncopal dizziness, followed by numbness of both feet 2 hrs p/vax;				Y					Y	11/19/1992	11/19/1992	0	NONE	MIL	MIL	NONE	NONE	tetracycline allergy	NONE~ ()~~~In patient		1						1	Dizziness; Paraesthesia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4928239~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0049814	02/10/1993	OH	84.0			M		pt originally adm 28NOV92 w/syncope, chronic atrial fibrillation, hypoxemia secondary to pneumonia & edema; mitral regurgitation; resp failure; alkalosis; acid-base disorder; paradoxical vent tachycardia; acute infect polyneuritis; poss GBS					Y					10/16/1992	11/28/1992	43	total CSF spinal fluid protein 249; predominate cell tyep-lymphocytes; CSF glucose-high 172mg/DL;	UNK	UNK	NA			~ ()~~~In patient		1						1	Alkalosis; Apnoea; Atrial fibrillation; CSF test abnormal; Guillain-Barre syndrome; Neuritis; Pneumonia; Ventricular tachycardia	FLU3~CONNAUGHT LABORATORIES~2F31099~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0049860	02/11/1993	MN	72.0	72		F	11/12/1992	5NOV devel muscular pain in legs & back unrelated to activity; 6NOV pain inc; 7NOV & 8NOV a little better; early 9NOV pain worsened & was hosp; xrays taken;					Y	3			N	10/21/1992	11/05/1992	15	xrays-results not yet given to pt;	PUB	PUB	Hydroxyuria	NONE	thrombocytopenia	~ ()~~~In patient	MN92054	1						1	Back pain; Myalgia; Pain	FLUX~PFIZER\WYETH~4928226~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0049861	02/11/1993	MN	77.0	77		F	11/19/1992	approx 1NOV92 devel achiness & sore throat which progressed to fever of 100 or higher, chills, chest congestion w/productive cough, sinus infection, w/yellow-green sinus drainage; tx w/PCN; 16NOV sinus infect dx;				Y					N	10/14/1992	11/01/1992	18	NONE	PUB	PUB	maxide, Potassium, Premarin, Presantine, Provera, Magnesium;	NONE	hypertension; heart murmur	~ ()~~~In patient	MN92055	1						1	Chills; Cough; Infection; Lung disorder; Myalgia; Pharyngitis; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~4928226~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0049894	02/12/1993	TN	20.0	20		F	01/12/1993	pt recvd vax 7JAN93; pt neck 7 back itching real bad face & back w/fine red spots; started itching 10JAN93; swollen & puffy under eyes, under nose & around jaw; poss allergic rxn;				Y					Y	01/07/1993	01/10/1993	3		PUB	PUB	Modicon	NONE		~ ()~~~In patient	TN93015	1						1	Face oedema; Hypersensitivity; Pruritus; Rash	FLUX~PFIZER\WYETH~4928233~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~1138V~2~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0049915	02/16/1993	TX				F	01/24/1993	pt recvd vax NOV92; hospitalized DEC92-dx GBS presented @ hosp w/viral sx; pt was transferred to a rehabilitation center; no other clinical info available;					Y				U	11/01/1992	12/01/1992	30	NA	PVT	PVT	NA			NA~ ()~~~In patient	930019401	1						1	Guillain-Barre syndrome; Infection	FLU3~LEDERLE LABORATORIES~~1~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation	Influenza
0049916	02/16/1993	CO	46.0	46		F	11/12/1992	12NOV92 tc from pt had flu vax on 6NOV92, onset of migraine type had 6NOV92 PM w/nausea & vomiting lasted approx 24 hrs; was in bed 7NOV & 8NOV D/T lethargy; c/o lethragy & some dizziness;				Y					Y	11/06/1992	11/06/1992	0	NA	PUB	PUB	Axid	? flu 2 wks ago, i.e. vomiting & diarrhe		~ ()~~~In patient	CO93002	1						1	Dizziness; Migraine; Nausea; Somnolence; Vomiting	FLUX~PFIZER\WYETH~4928287~1~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0049925	02/16/1993	TX	68.0	68		F	12/10/1992	flu inject was administered in deltoid on 10DEC92; pt reported arm was still sore but no sx were present;									Y	11/12/1992	11/26/1992	14	NONE	PUB	PUB	Synthroid, Drisdol, Viskin, Calcium Gluconate	NONE	NONE	NONE~ ()~~~In patient	TX92252	1						1	Myalgia	FLUX~PFIZER\WYETH~4928207~6~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0049955	02/17/1993	NM	58.0	58		F	02/04/1993	still off work, blurred vision, tires easily, weakness (muscle), GBS;			Y	Y	Y	17			Y	10/28/1992	11/17/1992	20		PUB	PUB	NONE	NONE	UNK	pt exp rxn @ 28 w/swine flu #1 vax;~ ()~~~In patient	NM93002	1						1	Amblyopia; Asthenia; Guillain-Barre syndrome; Myasthenic syndrome	FLUX~PFIZER\WYETH~4928218~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0049963	02/17/1993	MA	4.0	4		M	11/22/1992	giant urticaria @ vax site; urticaria on body 2-3 cm diameter on the rest of the body treated w/Pred;				Y					Y	11/10/1992	11/12/1992	2	NONE	PVT	PUB	Ventolin	NONE	asthma	~ ()~~~In patient		1						1	Injection site hypersensitivity; Urticaria	FLUX~PFIZER\WYETH~4928222~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0038343	02/18/1993	MA	68.0			F	11/13/1992	pt recvd flu vax & exp diarrhea, body aches, h/a;									U					OTH	OTH	UNK			~ ()~~~In patient	892324001E	1						2	Cough; Ear pain; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4928230~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0046298	02/18/1993	WI	52.0	52		F	10/23/1992	pt recvd flu vax & 5 days later devel itchy rash; arm was sore, achy, throbbing around inject site;									Y	10/01/1992	10/06/1992	5	NA	PVT	PVT	NONE	NONE	allergic to EES, tetracycline, sulfa drugs, Bactrim	~ ()~~~In patient	892301001K	1						2	Injection site pain; Pruritus; Rash	FLUX~PFIZER\WYETH~4928215~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0046412	02/18/1993	WA	29.0	29		F	10/12/1992	pt recvd flu vax & exp chills, myalgia, & fatigue for 2 days; also had a fever (101) & was dizzy;									Y	10/03/1992	10/03/1992	0		PVT	PVT		cold sxs started 5OCT92	pt has hashimoto's thyroiditis;	~ ()~~~In patient	892288011M	1						2	Asthenia; Chills; Dizziness; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~4928213~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0046413	02/18/1993	WA	44.0	44		F	10/12/1992	pt recvd flu vax & devel a wheal & pain @ inject site, accompanied by nausea, chills & fever; pt took DPH for the reaction;									Y	10/03/1992	10/03/1992	0	NONE	PVT	PVT	Clonidine patch;	NONE	pt is allergic to PNC (rash) & has a hx of breast;	NONE~ ()~~~In patient	892288012M	1						2	Chills; Injection site hypersensitivity; Injection site pain; Nausea; Pyrexia	FLUX~PFIZER\WYETH~4928213~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0046426	02/18/1993	WI	62.0	62		F	10/22/1992	pt recvd flu vax & devel swelling, redness & induration measuring 5x7 inches in the arm of inject;									Y	10/05/1992	10/05/1992	0	NONE	PVT	OTH	NONE	NONE	pt is allergic to PCN & Sulfa;	pt exp swelling p/recvd flu vax 1 yr ago;~ ()~~~In patient	892301007K	1						2	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLUX~PFIZER\WYETH~4928215~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0048251	02/18/1993	WI	25.0	25		F	12/03/1992	pt recvd flu vax & pt devel flu-like sx consisting of h/a & joint aches, which lasted for 24-48 hrs;									Y	10/15/1992	10/16/1992	1	NONE	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	892351001K	1						2	Arthralgia; Headache; Influenza	FLUX~PFIZER\WYETH~4928132~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0050086	02/18/1993	OR				M	11/30/1992	pt recvd flu vax & 5 mins later pt died; Wyeth is awaiting f/u info;	Y								N					OTH	OTH				~ ()~~~In patient	893022001E	1						1	Unevaluable event	FLUX~PFIZER\WYETH~4928231~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0050089	02/18/1993	CA	51.0	51		F	10/16/1992	pt recvd flu vax on 12OCT92; pt exp sl nausea that noc; 37 pts seen @ this dialysis center recvd vax from this lot; 32 had no adverse events; 2 pts had minor reactions the day of vax;									Y	10/12/1992	10/12/1992	0		OTH	PVT	various	following hemodialysis	pt has chronic renal failure	~ ()~~~In patient	892293004E	1						1	Nausea	FLUX~PFIZER\WYETH~4928234~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050090	02/18/1993	CA	56.0	56		F	10/16/1992	pt recvd flu vax on 12OCT92; that noc felt sl sick; 37 pts seen @ dialysis center recvd vax from this lot; 32 had no adverse events; 2 pts had minor reactions the day of vax; 2 others exp problems during dialysis sessions;									Y	10/12/1992	10/12/1992	0		OTH	PVT	various	following hemodialysis	pt has chronic renal failure	~ ()~~~In patient	892293005E	1						1	Malaise	FLUX~PFIZER\WYETH~4928234~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050091	02/18/1993	CA	30.0	29		F	10/09/1992	pt recvd flu vax & devel myalgia, dark urine (bilirubinuria), h/a, abdo pains, fever, fatigue 7 hepatosplenomegaly; sx peaked about 10 days p/vax;									Y	09/28/1992	10/03/1992	5	Alkaline Phosphatase-312; AST-382; ALT-144; LDH-476; urine bilirubin pos; WBC 1,900; platelets-40,000; hep A neg; Hep B neg;	MIL	MIL	oral contraceptives	NONE	pt recvd Hep B vax in 1989 w/documented antibody titers; has 4 prev flu vax & had flu-like sx following vax @ age 27;	pt exp general flu like @ 27 y/o w/flu #1;~ ()~~~In patient	892294001E	1						1	Asthenia; Bilirubinuria; Blood alkaline phosphatase increased; Blood lactate dehydrogenase increased; Hepatitis; Hepatosplenomegaly; Leukopenia; Thrombocytopenia	FLUX~PFIZER\WYETH~4928206~5~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050092	02/18/1993	IA	22.0	22		F	10/01/1992	pt recvd flu vax & exp a h/a 2 1/2 hrs later; pt also was dizzy that evening;				Y					U	09/30/1992	09/30/1992	0	NONE	OTH	OTH	oral contraceptives	NONE	NONE	~ ()~~~In patient	892295001E	1						1	Dizziness; Headache	FLUX~PFIZER\WYETH~4928150~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0050093	02/18/1993	IA	36.0	36		F	10/01/1992	pt recvd flu vax & devel itching & burning @ inject site;									U	09/30/1992	09/30/1992	0	NONE	OTH	OTH		NONE		~ ()~~~In patient	892295002E	1						1	Injection site pain; Pruritus	FLUX~PFIZER\WYETH~4928150~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050094	02/18/1993	IA				U	10/01/1992	pt recvd flu vax & devel soreness @ the inject site;									U					OTH	OTH	UNK			~ ()~~~In patient	892295003E	1						1	Injection site pain	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050095	02/18/1993	IA				U	10/01/1992	pt recvd flu vax & devel soreness @ inject site;									U					OTH	OTH	UNK			~ ()~~~In patient	892295004E	1						1	Injection site pain	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050096	02/18/1993	IA				U	10/01/1992	pt recvd flu vax & devel soreness @ inject site;									U					OTH	OTH	UNK			~ ()~~~In patient	892295005E	1						1	Injection site pain	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050098	02/18/1993	UT	43.0	43		F	10/07/1992	pt recvd flu vax & devel urticaria which migrated over the body sparing the inject site; reaction resolved p/2 to 3 days;									Y	10/01/1992	10/01/1992	0		MIL	MIL	NONE		pt is allergic to sulfa	~ ()~~~In patient	892301002K	1						1	Urticaria	FLUX~PFIZER\WYETH~4928206~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050099	02/18/1993	GA	40.0	40		F	10/20/1992	pt recvd flu vax & exp itching 3 hrs later; pruritus affected face, head, back, shoulders, & arms; given DPH;									Y	10/20/1992	10/20/1992	0		MIL	PUB	NONE	NONE	NONE	~ ()~~~In patient	892301003K	1						1	Pruritus	FLUX~PFIZER\WYETH~4928236~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050100	02/18/1993	MN	38.0	38		F	10/01/1992	pt recvd flu vax & exp redness & swelling @ inject site; reaction lasted 10 to 14 days;									Y	09/30/1992	10/01/1992	1	Lot # 4928220 was satisfactory w/no anomalies noted;	PVT	PVT	NONE			~ ()~~~In patient	892301004K	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4928220~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050101	02/18/1993	MI				U	10/15/1992	pt recvd flu vax & exp stinging @ the site of inject; stinging lasted several days;									U					OTH	OTH	UNK			~ ()~~~In patient	892301005K	1						1	Injection site pain	FLUX~PFIZER\WYETH~4928222~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050102	02/18/1993	NC	38.0	38		F	10/16/1992	pt recvd flu vax & approx  1 1/2 hrs later exp numbness on the rt side of the face, arms, & leg, accompanied by loss of sensation;									Y	10/16/1992	10/16/1992	0		PVT	PVT	NONE	NONE	NONE	pt exp numbness on the rt side of the face, arms, & leg, & loss sensation @ 37;~ ()~~~In patient	892301006K	1						1	Paraesthesia	FLUX~PFIZER\WYETH~~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050104	02/18/1993	RI	36.0	36		F	10/16/1992	pt recvd flu vax & 48 hrs later devel lt supraclavicular & axillary lymphadenopathy which resolved w/o tx over aprox 10 to 14 days;									Y	10/10/1992	10/12/1992	2		PVT	PVT	unk			~ ()~~~In patient	892301008K	1						1	Lymphadenopathy	FLUX~PFIZER\WYETH~4928227~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050105	02/18/1993	TX	36.0	36		F	10/22/1992	pt recvd flu vax & devel warmth, redness, & induration @ site of inject; 22OCT92 inject site began itching & was painful to touch;									Y	10/20/1992	10/20/1992	0	NONE	PUB	OTH		NONE	NONE	~ ()~~~In patient	892301009K	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050106	02/18/1993	KY	39.0	39		F	10/15/1992	pt recvd flu vax & exp vomiting which lasted 2 days; 3OCT92 pt devel hives over the thighs, back & arms, which persisted for over 2 1/2 wks; also had a lump in the rt axilla; 8DEC92, rash persists;									U	09/29/1992	10/01/1992	2	Rheum I profile, CBC w/diff, fasting SMA12, Thyroid function test, UA w/cult & sensitivity, Hep profile & CT scan;	OTH	OTH	Depoprovera, Dilantin,Bicon C, Dulcolax;		the pt is mentally retarded;	~ ()~~~In patient	892304001E	1						1	Rash; Subcutaneous nodule; Urticaria; Vomiting	FLUX~PFIZER\WYETH~4928112~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050107	02/18/1993	AR	41.0	41		F	10/15/1992	pt recvd flu vax & devel lymphadenopathy described as soreness w/ a raised area (3cm x 3xm) in the lt axilla; pt declined to seek medical treatment;									Y	10/13/1992	10/15/1992	2		PVT	PVT				~ ()~~~In patient	892304001K	1						1	Lymphadenopathy	FLUX~PFIZER\WYETH~4928133~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050108	02/18/1993	AR	53.0	52		F	10/15/1992	pt recvd flu vax & exp severe frontal h/a, nausea, & diarrhea; sx lasted approx 3 days;									Y	10/13/1992	10/14/1992	1		PVT	PVT	Premarin			~ ()~~~In patient	892304002K	1						1	Diarrhoea; Headache; Nausea	FLUX~PFIZER\WYETH~4928133~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050109	02/18/1993	UT	33.0			F	10/20/1992	pt recvd flu vax & devel swelling w/in 2 hrs which measured 2 around the arm; reaction lasted 2 days;									Y	10/06/1992	10/06/1992	0		MIL	OTH	unk			~ ()~~~In patient	892304003K	1						1	Oedema peripheral	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050110	02/18/1993	UT	3.0	3		F	10/20/1992	pt recvd flu vax & devel swellling form the shoulder to the elbow w/in 2 to 3 hrs; pt also had a fever; the swelling lasted 1 wk; pt recvd an flu vax last year w/no problems;									U	10/14/1992	10/14/1992	0		MIL	OTH	UNK	UNK		~ ()~~~In patient	892304004K	1						1	Oedema peripheral; Pyrexia	FLUX~PFIZER\WYETH~4928235~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050111	02/18/1993	MA	35.0			F	10/19/1992	pt recvd flu vax & approx 1 hr later c/o feeling lightheaded & had a prickly feeling; felt faint, hot in the chest, flushed; BP 138/78; 2 hrs later felt better;				Y					Y	10/15/1992	10/15/1992	0	NONE	PUB	PVT	amitryptiline	NONE	NONE	~ ()~~~In patient	892304005K	1						1	Dizziness; Vasodilatation	FLUX~PFIZER\WYETH~4928131~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0050112	02/18/1993	NC	38.0	38		F		pt recvd flu vax & exp burning & stinging @ the site of inject, characterized as much worse than last year; reaction lasted 1 wk;									Y	10/09/1992	10/09/1992	0		OTH	OTH	NONE		pt is allergic to PCN;	~ ()~~~In patient	892304006K	1						1	Injection site pain	FLUX~PFIZER\WYETH~4928228~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050118	02/18/1993	NJ	56.0			U	10/09/1992	pt recvd flu vax & devel sl swelling @ the inject site which lasted for 2 to 3 days;									U					OTH	OTH	UNK			~ ()~~~In patient	892304012K	1						1	Injection site oedema	FLUX~PFIZER\WYETH~4928113~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050119	02/18/1993	NJ	12.0			U	10/09/1992	pt recvd flu vax & exp immed local swelling & redness;									U					OTH	OTH	UNK			~ ()~~~In patient	892304013K	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4928113~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050120	02/18/1993	NJ				U	10/09/1992	pt recvd flu vax & devel local redness & soreness in the arm of inject;									U					OTH	OTH	UNK			~ ()~~~In patient	892304014K	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4928113~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050121	02/18/1993	NJ	51.0			U	10/09/1992	pt recvd flu vax & devel local swelling & warmth for 5 days;									U					OTH	OTH	UNK			~ ()~~~In patient	892304015K	1						1	Injection site oedema; Vasodilatation	FLUX~PFIZER\WYETH~4928113~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050122	02/18/1993	NJ	40.0			U	10/09/1992	pt recvd flu vax & exp immed lt arm pain which radiated to the neck & shoulders & lightheadedness;									U					OTH	OTH	UNK			~ ()~~~In patient	892304016K	1						1	Dizziness; Neck pain; Pain	FLUX~PFIZER\WYETH~4928113~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050123	02/18/1993	NC	28.0	28		F	10/21/1992	pt recvd flu vax & exp h/a, dry mouth & numbness on the rt side of the face approx 8PM that evening; the next day sx had resolved x/some residual numbness in the lip & chin for 48 hrs;									Y	10/20/1992	10/20/1992	0		PVT	OTH	Demulen	NONE		~ ()~~~In patient	892310002K	1						1	Dry mouth; Headache; Paraesthesia	FLUX~PFIZER\WYETH~4928232~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050124	02/18/1993	MI	50.0	49		F	10/29/1992	pt recvd flu vax & 2 days later exp itching, pain, 1 1/2 x 2 1/2 in area of erythema & a 1 x 2 in area of induration; prescribed DPH;				Y					Y	10/21/1992	10/23/1992	2		PVT	PVT	NONE	NONE	pt has hyperlipidemia	~ ()~~~In patient	892310003K	1						1	Injection site hypersensitivity; Injection site mass; Pain; Pruritus	FLUX~PFIZER\WYETH~4928220~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0050125	02/18/1993	GA	23.0	23		F	10/26/1992	pt recvd flu vax & the next day devel a sore throat & fever to 102-103 which lasted into the evening; 5 days later devel an all-over body macular, non-pruritic rash;									Y	10/20/1992	10/26/1992	6	rapid strep test was neg;	PVT	OTH	Oral contraceptives	NONE	pt is allergic to pollen	~ ()~~~In patient	892310004K	1						1	Pharyngitis; Pyrexia; Rash maculo-papular	FLUX~PFIZER\WYETH~4928236~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050126	02/18/1993	OH	64.0	64		F	10/30/1992	pt recvd flu vax on 21OCT92 & on 25OCT92 & devel pruritic rash over neck & supraclavicular area which lasted 5 days; MD felt was allergic reaction; cont w/burning & itching;				Y					Y	10/21/1992	10/25/1992	4	NONE	PVT	PVT	Timoptic		pt has hx of melanoma, hypercholesterolemia, degenerative joint disease, & glaucoma; pt mildly sore arm w/prev flu	~ ()~~~In patient	892310005K	1						1	Hypersensitivity; Pain; Pruritus; Rash	FLUX~PFIZER\WYETH~4928232~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0050127	02/18/1993	OH				F	10/30/1992	pt recvd flu vax & exp soreness @ the inject site & flu-like sx;									U					OTH	OTH				~ ()~~~In patient	892310006K	1						1	Influenza; Injection site pain	FLUX~PFIZER\WYETH~4928232~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050128	02/18/1993	PA	38.0	38		F	10/23/1992	pt recvd flu vax & exp soreness in the arm of inject most of the day; approx 10PM, arm became extremely sore, w/o swelling or discoloration; approx 1AM pt exp chills & spastic shakes; pt was unable to get warm despite layers of blankets;									Y	10/21/1992	10/21/1992	0	had flu vax for previous 3yrs w/no reaction;	PUB	PUB	NONE	NONE	pt has had flu vax in 3 prev yrs w/o reaction; has had frequent reactions to OTC meds;	~ ()~~~In patient	892310007K	1						1	Asthenia; Chills; Hypertonia; Myalgia; Pyrexia; Tremor	FLUX~PFIZER\WYETH~4928204~4~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050129	02/18/1993	MN	55.0	55		F	10/30/1992	pt recvd flu vax & exp vertigo 1/2 hr later which lasted for 3 to 4 hrs; the next day devel 4 hive described as like cellulitis which was erythematous & warm to the touch; also had pain in the axilla;									Y	10/26/1992				PVT	PVT	Demulen, Ranitidine;	NONE	NONE	~ ()~~~In patient	892310009K	1						1	Cellulitis; Pain; Rash; Urticaria; Vasodilatation; Vertigo	FLUX~PFIZER\WYETH~4928244~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050130	02/18/1993	TX				U	10/30/1992	pt recvd flu vax & exp fatigue & mild flu-like sx;									U					OTH	OTH	UNK			~ ()~~~In patient	892310010K	1						1	Asthenia; Influenza	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050131	02/18/1993	NY	45.0	45		F	10/30/1992	pt recvd flu vax & exp h/a, fever & chills;				Y					U	10/29/1992	10/30/1992	1		PVT	OTH	UNK			~ ()~~~In patient	892310011K	1						1	Cough; Injection site mass; Myalgia; Pharyngitis; Pyrexia; Rash; Rhinitis; Somnolence	FLUX~PFIZER\WYETH~4928113~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0050132	02/18/1993	NY	38.0	38		F	10/30/1992	pt recvd flu vax & exp h/a, fever, chills;									U	10/28/1992	10/29/1992	1		PVT	OTH	UNK			~ ()~~~In patient	892310012K	1						1	Injection site oedema; Lymphadenopathy; Pyrexia	FLUX~PFIZER\WYETH~4928113~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050133	02/18/1993	NY	42.0	42		F	10/30/1992	pt recvd flu vax & exp redness @ inject site;									Y	10/10/1992	10/10/1992	0		OTH	OTH	unk			~ ()~~~In patient	892314001K	1						1	Arthralgia; Bone pain; Diarrhoea; Dyspepsia; Headache; Nausea	FLUX~PFIZER\WYETH~4928113~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050134	02/18/1993	NY				F	10/30/1992	pt recvd flu vax & exp redness @ the inject site;									Y	10/27/1992	10/27/1992	0		OTH	OTH	UNK			~ ()~~~In patient	892314002K	1						1	Injection site hypersensitivity	FLUX~PFIZER\WYETH~4928113~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050135	02/18/1993	NY				U	10/30/1992	pt exp flu vax & exp redness @ inject site;									Y	10/01/1992				OTH	OTH	UNK			~ ()~~~In patient	892314003K	1						1	Injection site hypersensitivity	FLUX~PFIZER\WYETH~4928113~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050136	02/18/1993	NY	42.0	42		F	10/30/1992	pt recvd flu vax & exp redness @ the inject site;									Y	10/27/1992	10/27/1992	0		OTH	OTH	UNK			~ ()~~~In patient	892314004K	1						1	Injection site hypersensitivity; Lymphadenopathy	FLUX~PFIZER\WYETH~4928113~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050137	02/18/1993	NY	39.0	39		M	10/30/1992	Pt recvd flu vax & exp redness @ inject site;									Y	10/27/1992	10/28/1992	1		OTH	OTH	UNK			~ ()~~~In patient	892314005K	1						1	Paraesthesia; Vasodilatation	FLUX~PFIZER\WYETH~4928113~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050138	02/18/1993	PA	74.0	74		F	10/27/1992	pt recvd flu vax & 3 days later devel a reaction @ the inject site consisting of erythema & rash; pt also devel a pruritic rash on arms, back, face, & scalp;									Y	10/06/1992	10/09/1992	3		PVT	PVT		NONE	pt has obstructive lung disease 7 cataracts;	~ ()~~~In patient	892314007K	1						1	Injection site hypersensitivity; Pruritus; Rash	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050139	02/18/1993	CA	46.0	46		F	10/29/1992	pt recvd flu vax & approx 7 days later, devel sinusitis w/swelling around the sinus cavities & over the bridge of the nose; pt also had a local reaction w/ a 4cm band of erythema encircling the arm;				Y					Y	10/08/1992	10/18/1992	10		PVT	PVT	NONE			~ ()~~~In patient	892314008K	1						1	Face oedema; Injection site hypersensitivity; Sinusitis	FLUX~PFIZER\WYETH~4928219~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0050140	02/18/1993	FL				F	11/04/1992	pt recvd flu vax & 3 days later devel a h/a that persisted 4 days & a fever to 103.5 7 joint pain that persisted 8 days; 4NOV92 devel a erythematous raised rash on chest extremities;									U	10/23/1992	10/26/1992	3		PVT	OTH	UNK			~ ()~~~In patient	892314009K	1						1	Arthralgia; Headache; Pyrexia; Rash maculo-papular	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050141	02/18/1993	KY	36.0	36		F	10/30/1992	pt recvd flu vax & exp intense itching; 28OCT92 devel redness, rash & swelling of the arm of inject from the shoulder to elbow;									Y	10/27/1992	10/28/1992	1		PUB	OTH	Inderal		pt is allergic to mold, pollen, cat hair, dust;	~ ()~~~In patient	892314010K	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLUX~PFIZER\WYETH~4928204~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050142	02/18/1993	OH	42.0	42		F	10/22/1992	pt recvd flu vax & the following day devel soreness, redness, itching, & warmth @ the inject site;									Y	10/19/1992	10/20/1992	1		PUB	OTH			pt is allergic to Voltaren; pt has arthritis;	~ ()~~~In patient	892314011K	1						1	Injection site hypersensitivity; Injection site pain; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~4928232~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050143	02/18/1993	OH	47.0	47		F	10/22/1992	pt recvd flu vax & the following day, pt devel soreness, redness, itching, & warmth @ the inject site;									Y	10/19/1992	10/21/1992	2		PUB	OTH				~ ()~~~In patient	892314012K	1						1	Injection site hypersensitivity; Injection site pain; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~4928232~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050144	02/18/1993	OH	64.0	63		F	10/22/1992	pt recvd flu vax & the following day, pt devel edema & warmth @ the inject site;									U	10/19/1992	10/21/1992	2		PUB	OTH				~ ()~~~In patient	892314013K	1						1	Injection site oedema; Vasodilatation	FLUX~PFIZER\WYETH~4928232~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050145	02/18/1993	OH	58.0	58		F	10/22/1992	pt recvd flu vax & the following day, pt devel pain, erythema, & warmth @ the inject site;									Y	10/19/1992	10/20/1992	1		PUB	OTH				~ ()~~~In patient	892314014K	1						1	Injection site hypersensitivity; Injection site pain	FLUX~PFIZER\WYETH~4928232~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050146	02/18/1993	OH	35.0	35		M	10/22/1992	pt recvd flu vax & the following day, pt devel soreness & edema in the area of the inject site, which lasted for 12 days; also had gastrointestinal upset & diarrhea;									Y	10/19/1992	10/20/1992	1		PUB	OTH				~ ()~~~In patient	892314015K	1						1	Diarrhoea; Dyspepsia; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~4928232~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050147	02/18/1993	OH	35.0	35		F	10/22/1992	pt recvd flu vax & 16 to 24 hrs later, pt devel pain, swelling, redness, induration, warmth @ the inject site; reaction lasted 4 days;									Y	10/19/1992	10/20/1992	1		PVT	OTH				~ ()~~~In patient	892314016K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Vasodilatation	FLUX~PFIZER\WYETH~4928232~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050148	02/18/1993	OH	40.0	40		F	10/22/1992	pt recvd flu vax & 16 to 24 hrs later, pt devel pain, swelling, redness, induration, & warmth @ the inject site; reaction lasted 4-5 days;									Y	10/19/1992	10/20/1992	1		PVT	OTH			pt is allergic to dust, dust mites, molds & grass;	~ ()~~~In patient	892314017K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Vasodilatation	FLUX~PFIZER\WYETH~4928232~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050149	02/18/1993	OH				F	10/22/1992	pt recvd flu vax & the following day, pt devel swelling, redness, & warmth @ the inject site;									Y		10/01/1992			OTH	OTH				~ ()~~~In patient	892314018K	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLUX~PFIZER\WYETH~4928232~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050150	02/18/1993	WA	68.0	68		M	11/06/1992	pt recvd flu vax & 3 days later pt exp pain in the shoulder which extended down the arm to below the elbow; 19NOV92 pt reported tenderness to palpation in the rt brachioradialis muscle w/aching @ noc; also soreness in the arm;									N	10/19/1992	10/22/1992	3		PUB	PUB		NONE	NONE	~ ()~~~In patient	892314021K	1						1	Myalgia; Pain	FLUX~PFIZER\WYETH~4928205~6~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TYP~PFIZER\WYETH~4918031~3~SC~LA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0050151	02/18/1993	NY				F	10/27/1992	pt recvd flu vax & 3 days later, devel redness of the lt eye;									U	10/23/1992	10/26/1992	3		OTH	OTH	unk		pt is on renal dialysis	~ ()~~~In patient	892317003E	1						1	Conjunctivitis	FLUX~PFIZER\WYETH~4928135~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050152	02/18/1993	NY	53.0	53		F	10/27/1992	pt recvd flu vax & 3 days later lt eye was itchy & rubed it & turned red;									Y	10/23/1992	10/26/1992	3		PUB	PUB		NONE	pt is on renal dialysis & has hypertension;	~ ()~~~In patient	892317004E	1						1	Conjunctivitis; Pruritus	FLUX~PFIZER\WYETH~4928135~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050153	02/18/1993	OR	25.0	25		M	10/28/1992	pt devel axillary lymphadenopathy coincident w/administration of flu vax;									Y	09/25/1992	10/23/1992	28	NONE	OTH	OTH	weekly allergy injections, prednisone for asthma;		pt has asthma & had upper resp infect on 14SEP92;	~ ()~~~In patient	892317005E	1						1	Lymphadenopathy	FLUX~PFIZER\WYETH~4928221~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050155	02/18/1993	WI	40.0	40		F	11/10/1992	pt recvd flu vax & exp severe depression, manifested as sobbing; also exp pain & heat @ the inject site; pt was taken to ER where was treated w/Pred for 5 days & Ativan for 7 days; still depressed;				Y					Y	10/31/1992			NONE	PVT	PVT	Nardil, Ritalin, Halcion, Intal, Maxair Inhaler, Orudis		pt is allergic to Tetracycline, Sulfa, Ludiomil, APAP	pt exp itching @ inject site @ 39 y/o w/flu vax #1;~ ()~~~In patient	892324002E	1						1	Affect lability; Depression; Injection site pain; Vasodilatation	FLUX~PFIZER\WYETH~4928136~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0050156	02/18/1993	CA				U	10/27/1992	pt devel a local reaction @ inject site p/receiving vax; pt recvd vax SC rather than by recommended IM;									U					OTH	OTH				~ ()~~~In patient	892328001K	1						1	Myalgia	FLUX~PFIZER\WYETH~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050157	02/18/1993	CA	63.0	63		M	10/27/1992	pt exp a seizure w/LOC 2 hrs p/receiving flu vax; previously had surgery for removal of a brain tumor;				Y					U	10/02/1992	10/02/1992	0		PVT	OTH	NONE	hx of brain tumor w/surgical excision;		~ ()~~~In patient	892328002K	1						1	Convulsion; Syncope	FLUX~PFIZER\WYETH~4928219~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0050158	02/18/1993	SD	25.0	25		F	10/28/1992	pt exp erythema, induration, inflammation, & swelling @ the inject site p/recvd flu vax;									U	10/26/1992	10/27/1992	1		OTH	OTH				~ ()~~~In patient	892328003K	1						1	Injection site hypersensitivity; Injection site inflammation; Injection site mass; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~4928114~3~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050159	02/18/1993	SD				U	10/28/1992	pt exp erythema, induration, inflammation, & swelling @ inject site p/flu vax;									U					OTH	OTH				~ ()~~~In patient	892328004K	1						1	Injection site hypersensitivity; Injection site inflammation; Injection site mass; Injection site oedema	FLUX~PFIZER\WYETH~4928114~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050160	02/18/1993	SD				U	10/28/1992	pt exp erythema, induration, inflammation, & swelling @ the inject site p/vax;									U					OTH	OTH				~ ()~~~In patient	892328005K	1						1	Injection site hypersensitivity; Injection site inflammation; Injection site mass; Injection site oedema	FLUX~PFIZER\WYETH~4928114~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050161	02/18/1993	SD				U	10/28/1992	Pt exp erythema, induration, inflammation, & swelling @ the inject site p/receiving vax;									U					UNK	UNK				~ ()~~~In patient	892328006K	1						1	Injection site hypersensitivity; Injection site inflammation; Injection site mass; Injection site oedema	FLUX~PFIZER\WYETH~4928114~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050162	02/18/1993	VA	58.0			F	10/28/1992	pt recvd flu vax & the following vax exp a local reaction consisting of erythema, swelling, & warmth @ the inject site; also arthritic-like sx (fingers red & swollen) & fever; redness @ inject site & sl swelling of fingers;									Y	10/20/1992	10/21/1992	1		PVT	PVT			pt has no known drug allergies & rheumatoid arthritis;	~ ()~~~In patient	892328007K	1						1	Arthritis; Injection site hypersensitivity; Injection site oedema; Osteoarthritis; Pyrexia; Vasodilatation	FLUX~PFIZER\WYETH~4928230~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050163	02/18/1993	MD	22.0			M	10/30/1992	pt recvd flu vax & 2 days later exp tenderness @ inject site & ax lymphadenopathy;				Y					Y	10/27/1992	10/29/1992	2		UNK	UNK				~ ()~~~In patient	892328008K	1						1	Injection site pain; Lymphadenopathy	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0050164	02/18/1993	NJ				U	11/05/1992	Pt recvd flu vax & devel a rash @ the inject site which measured 60mm & facial numbness; neurologist assessed as mild sensory neuropathy;									U	10/14/1992	10/16/1992	2		OTH	OTH				~ ()~~~In patient	892328009K	1						1	Injection site hypersensitivity; Neuropathy; Paraesthesia	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050165	02/18/1993	NY				U	11/06/1992	pt recvd flu vax & devel diarrhea;									U					OTH	OTH				~ ()~~~In patient	892328010K	1						1	Diarrhoea	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050166	02/18/1993					F	11/09/1992	pt recvd flu vax & 2 wks later exp flu-like sx; pt wishes to reamin anonymous, & did not provide name or MD info;									U					OTH	OTH	UNK			~ ()~~~In patient	892328011K	1						1	Influenza	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050167	02/18/1993	FL				U	11/09/1992	pt recvd flu vax & devel flu-like sx;									U					PVT	OTH	UNK			~ ()~~~In patient	892328012K	1						1	Influenza	FLUX~PFIZER\WYETH~4928213~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050168	02/18/1993	CO	61.0	61		F	10/29/1992	pt recvd flu vax & exp pain, w/o swelling, a limited ROM, which has persisted 13 days p/inject; pain has waxed & waned; pt recovered;									Y	10/29/1992	10/29/1992	0		PVT	PVT			pt states had a severe reaaction to flu vax 5 yrs ago;	pt exp severe reaction @ 56 y/o w/flu vax;~ ()~~~In patient	892328013K	1						1	Hypokinesia; Pain	FLUX~PFIZER\WYETH~4928224~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050169	02/18/1993	OK				F	11/13/1992	pt recvd flu vax & devel a baseball sized welt @ the site of inject; redness was followed by pruritus; reaction  persisted 4-5 days;									Y					OTH	OTH	UNK			~ ()~~~In patient	892328015K	1						1	Injection site hypersensitivity; Injection site mass; Pruritus	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050170	02/18/1993	OK				U	11/13/1992	pt recvd flu vax & devel a baseball sized welt @ the site of inject; redness was followed by pruritus; reaction persisted for 4-5 days;									Y					OTH	OTH	UNK			~ ()~~~In patient	892328016K	1						1	Injection site hypersensitivity; Injection site mass; Pruritus	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050171	02/18/1993	OK				U	11/13/1992	pt recvd flu vax & devel a baseball sized welt @ the site of inject; redness was followed by pruritus; reaction persisted 4-5 days;									Y					OTH	OTH	UNK			~ ()~~~In patient	892328017K	1						1	Injection site hypersensitivity; Injection site mass; Pruritus	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050172	02/18/1993	TX	43.0	43		F	11/16/1992	pt recvd flu vax & devel pain described as neuralgia/tendonitis like in the arm of inject; pt exp this pain when moving arm; seen by orthopedist who prescribed PT; pt recovered;									Y	10/14/1992	10/14/1992	0		PUB	PVT	NONE			~ ()~~~In patient	892328018K	1						1	Neuralgia; Tendon disorder	FLUX~PFIZER\WYETH~4928223~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050173	02/18/1993	FL	46.0	46		F	11/09/1992	pt recvd flu vax & devel an area of erythema & edema 1 1/2 in diameter 2 days later;									Y	11/03/1992	11/04/1992	1		PVT	PVT		NONE	NONE	~ ()~~~In patient	892328019K	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4928233~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050174	02/18/1993	FL	41.0	41		F	11/09/1992	pt recvd flu vax & devel an area of erythema & edema 1 1/2 in diameter 2 days later;									Y	11/04/1992	11/06/1992	2		PVT	PVT		NONE	NONE	~ ()~~~In patient	892328020K	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4928233~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050175	02/18/1993	FL	30.0	30		F	11/09/1992	pt recvd flu vax & devel an area of erythema & edema 1 1/2 in diameter 2 days later;									Y	11/04/1992	11/05/1992	1		PVT	PVT		NONE	NONE	~ ()~~~In patient	892328021K	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4928233~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050176	02/18/1993	MA	52.0	52		F	11/09/1992	pt exp flu-like sx & muscle edema p/receiving flu vax;				Y					U	11/02/1992				OTH	OTH	UNK			~ ()~~~In patient	892338001K	1						1	Hypokinesia; Oedema; Pain	FLUX~PFIZER\WYETH~4928230~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0050177	02/18/1993	PA				F	11/19/1992	pt recvd flu vax & devel 3 area of redness & pruritus @ the site of inject; also devel raised, red welts on neck & chest;									U	11/12/1992				MIL	OTH	Azmacort, Estrogen Patch, Antidepressant;			~ ()~~~In patient	892338002K	1						1	Injection site hypersensitivity; Pruritus; Urticaria	FLUX~PFIZER\WYETH~4928208~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050178	02/18/1993	NY	63.0	63		F	11/17/1992	pt recvd flu vax & exp pain in the arm of inject from neck to the hand; pt continues to have pain 1 mo p/vax;				Y				Y	U	10/20/1992	10/21/1992	1		PVT	OTH	UNK	NONE		~ ()~~~In patient	892338003K	1						1	Pain; Paraesthesia; Headache; Hypoaesthesia; Injection site pain; Pain	FLUX~PFIZER\WYETH~~7+~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928241~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Disabling	Influenza
0050179	02/18/1993	MD				U	11/20/1992	pt recvd flu vax & devel thrombocytopenia;									U					OTH	OTH	UNK			~ ()~~~In patient	892338004K	1						1	Thrombocytopenia	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050180	02/18/1993	PA	71.0	71		F	11/02/1992	pt exp erythema & soreness @ the inject site p/receiving flu vax;									U	09/18/1992	09/18/1992	0		OTH	OTH				~ ()~~~In patient	892338004P	1						1	Injection site hypersensitivity; Pruritus	FLUX~PFIZER\WYETH~4928213~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050181	02/18/1993	KY				F	11/17/1992	pt recvd flu vax & 24 hrs later exp vomiting, diarrhea, fever to 103, blisters in mouth, axillary swelling & a local reaction consisting of swelling, heat, & redness of upper arm;									U	11/05/1992	11/06/1992	1		OTH	OTH	UNK			~ ()~~~In patient	892338005P	1						1	Diarrhoea; Injection site hypersensitivity; Injection site oedema; Lymphadenopathy; Mouth ulceration; Pyrexia; Vasodilatation; Vomiting	FLUX~PFIZER\WYETH~4928133~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050182	02/18/1993	MN				F	11/13/1992	pt recvd flu vax & devel tightening, stiffness, soreness of the neck muscles, followed by a h/a; no other pt receiving vax from this lot had a similar reaction;									U	10/19/1992			lot# 4928229 was inspected & found to be satisfactory;	PVT	OTH	UNK			~ ()~~~In patient	892338006K	1						1	Headache; Hypertonia; Myalgia	FLUX~PFIZER\WYETH~4928229~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050183	02/18/1993	KY				U	11/17/1992	pt exp soreness, erythema, & swelling @ the inject site p/receiving flu vax;									U	11/05/1992				OTH	OTH	UNK			~ ()~~~In patient	892338006P	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~4928133~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050184	02/18/1993	UT	50.0			F	11/24/1992	pt recvd flu vax & devel a wheal which was characterized as near necrosis w/deep bruising & swelling for 3-4 days; pt also exp pain & heat in the arm of inject;									U	11/01/1992				OTH	OTH	unk			~ ()~~~In patient	892338007K	1						1	Ecchymosis; Injection site hypersensitivity; Injection site mass; Oedema; Pain; Urticaria; Vasodilatation	FLUX~PFIZER\WYETH~4928224~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050185	02/18/1993	KY				U	11/17/1992	pt exp mild flu sx p/receiving flu vax;									U	11/05/1992				OTH	OTH	unk			~ ()~~~In patient	892338007P	1						1	Influenza	FLUX~PFIZER\WYETH~4928133~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050186	02/18/1993	UT	20.0			M	11/24/1992	pt recvd flu vax & pt devel wheal which was characterized as near necrosis w/deep bruising & swelling 3-4 days; pt also exp pain & heat in the arm of inject;									U	11/01/1992				OTH	OTH	UNK			~ ()~~~In patient	892338008K	1						1	Ecchymosis; Injection site hypersensitivity; Injection site mass; Oedema; Pain; Urticaria; Vasodilatation	FLUX~PFIZER\WYETH~4928224~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050187	02/18/1993	MN	35.0			F	10/01/1992	Pt exp pain & swelling @ the inject site p/receiving flu vax;									Y	09/30/1992	09/30/1992	0		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	892338008P	1						1	Injection site oedema; Injection site pain; Injection site hypersensitivity; Injection site pain	FLUX~PFIZER\WYETH~4928220~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928220~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0050187	02/18/1993	MN				F	10/01/1992	pt exp erythema (5-6 inches in diameter) & soreness @ the inject site p/receiving flu vax; reaction lasted 10 to 14 days;									Y	09/30/1992	09/30/1992	0		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	892338010P	1						2	Injection site oedema; Injection site pain; Injection site hypersensitivity; Injection site pain	FLUX~PFIZER\WYETH~4928220~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928220~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0050188	02/18/1993	UT	50.0			F	11/24/1992	pt recvd flu vax & pt devel wheal, accompanied by swelling, pain & heat;									U	11/01/1992				OTH	OTH				~ ()~~~In patient	892338009K	1						1	Oedema; Pain; Pyrexia; Urticaria; Vasodilatation	FLUX~PFIZER\WYETH~4928224~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050189	02/18/1993	MN	38.0	38		F	10/01/1992	pt exp soreness, swelling, & bruising @ the inject site p/receiving flu vax;									Y	09/30/1992	09/30/1992	0		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	892338009P	1						1	Ecchymosis; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~4928220~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050190	02/18/1993	UT				U	11/24/1992	pt recvd flu vax & pt devel wheal, accompanied by swelling, pain & heat;									U					OTH	OTH				~ ()~~~In patient	892338010K	1						1	Oedema; Pain; Urticaria; Vasodilatation	FLUX~PFIZER\WYETH~4928224~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050192	02/18/1993	UT				U	11/24/1992	pt recvd flu vax & pt devel a wheal, accompanied by swelling, pain & heat;									U					OTH	OTH				~ ()~~~In patient	892338011K	1						1	Oedema; Pain; Urticaria; Vasodilatation	FLUX~PFIZER\WYETH~4928224~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050193	02/18/1993	MN	39.0	39		F	10/01/1992	pt exp swelling & erythema @ inject site p/receiving flu vax; reaction lasted a couple of days;									U	10/01/1992	10/01/1992	0		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	892338011P	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4928220~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050194	02/18/1993	MN	44.0	44		F	10/01/1992	pt exp swelling & erythema @ inject site p/receiving flu vax; reaction lasted 3-4 days;									Y	09/30/1992	09/30/1992	0		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	892338012P	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4928220~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050195	02/18/1993	IA	70.0			M	11/20/1992	pt recvd flu vax & devel wheezing, coughing, & excess phlegm; pt has been treated w/tetracycline, theophylline, Proventil inhaler, Pred, alupent, & cipro; pt is getting worse;									N	10/23/1992				OTH	OTH	UNK			pt exp similar reaction @ 69 w/flu vax #1;~ ()~~~In patient	892338013K	1						1	Asthma; Cough	FLUX~PFIZER\WYETH~~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050196	02/18/1993	PA	21.0	21		M	11/10/1992	pt recvd flu vax on 8OCT92 approx 8 hrs later exp swelling & pain in the arm of inject; next day devel numbness & was unable to use rt arm & hand; blood sugars became elevated to greater than 500mg%; pt seen in ER w/n,d, abdo cramps, pain;				Y					U	10/08/1992	10/09/1992	1	The pt had electromyelography & nerve conduction studies;	PVT	PVT	Bentyl, Insulin	NONE	pt has had diabetes mellitus (insulin dependent) for 9 years;	~ ()~~~In patient	892338014P	1						1	Abdominal pain; Diarrhoea; Hyperglycaemia; Hypokinesia; Neuropathy; Oedema; Paraesthesia; Vomiting	FLUX~PFIZER\WYETH~4928213~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0050197	02/18/1993	CA	36.0	36		F	11/16/1992	pt recvd flu vax & w/in 48 hrs devel redness, edema, soreness, described as like cellulitis, in the arm of inject; pt was treated w/local applications of ice & APAP;									Y	11/10/1992	11/13/1992	3		PVT	PVT	Tenormin, Nitroglycerin, Isordil, Nitro-dur patch		pt has mitral valve prolapse, arterial spasms & unstable angina;	~ ()~~~In patient	892339001K	1						1	Cellulitis; Myalgia; Oedema; Vasodilatation; Cellulitis; Myalgia; Vasodilatation	FLUX~PFIZER\WYETH~4928234~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928234~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0050197	02/18/1993	CA	47.0	47		F	11/16/1992	pt recvd flu vax & exp redness & soreness, described as cellulitis, in the arm of inject; pt was seen in clinic; it is unk if was treated; pt better 1 wk p/inject;									Y	11/10/1992	11/13/1992	3		PVT	PVT	Premarin, Seldane, Demerol	Hypertension	pt has hypertension	~ ()~~~In patient	892339002K	1						2	Cellulitis; Myalgia; Oedema; Vasodilatation; Cellulitis; Myalgia; Vasodilatation	FLUX~PFIZER\WYETH~4928234~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928234~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0050199	02/18/1993	CA	55.0	55		F	11/16/1992	pt recvd flu vax & devel redness, edema, soreness in the arm of inject; pt was seen by MD who felt this was a reaction to serum; pt was treated w/ATB for cellulitis; as of 16NOV92 sx are almost resolved;				Y					Y	11/11/1992	11/13/1992	2		PVT	PVT	NONE		NONE	~ ()~~~In patient	892339003K	1						1	Cellulitis; Myalgia; Oedema; Vasodilatation	FLUX~PFIZER\WYETH~4928234~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0050200	02/18/1993	ME	49.0	49		F	11/24/1992	pt recvd flu vax & devel severe nausea, vomiting, diarrhea, h/a & mylagia; pt was treated w/Compaxine;				Y					Y	11/19/1992	11/19/1992	0	K 3.9; creatinine .7; BUN 13; NA 137; CL 98;	PUB	PVT	Kerione		pt had nasal congestion 1 wk prior to immun	~ ()~~~In patient	892339004K	1						1	Diarrhoea; Headache; Myalgia; Nausea; Vomiting	FLUX~PFIZER\WYETH~4928134~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0050201	02/18/1993	ME	39.0	38		F	11/24/1992	pt recvd flu vax & approx 3 hrs later devel fever & myalgia followed by night sweats, cough, h/a, nausea & chills; 1 wk later was given a dx of pneumonia; MD did not feel the pneumonia was related to flu shot;				Y					Y	11/11/1992	11/11/1992	0		PUB	PVT	Prozac, Bentyl			~ ()~~~In patient	892339005K	1						1	Chills; Cough; Headache; Hyperhidrosis; Myalgia; Nausea; Pneumonia; Pyrexia	FLUX~PFIZER\WYETH~4928134~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0050202	02/18/1993	PA	65.0	65		F	11/24/1992	pt recvd flu vax on 9NOV92 & 12 hrs later exp redness, swelling, & pain in arm of inject; joints became painful & devel a low fever & chills; sx lasted approx 2 dyas; also mild inject site pain;									Y	11/09/1992	11/09/1992	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	892343001K	1						1	Arthralgia; Chills; Injection site pain; Oedema; Pain; Pyrexia; Vasodilatation	FLUX~PFIZER\WYETH~4928204~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050204	02/18/1993	WI	34.0	34		F	12/03/1992	pt recvd flu vax & pt devel nausea, headache, & diarrhea & reported moderate soreness @ inject site;									Y	10/28/1992	10/30/1992	2	NONE	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient	892351002K	1						1	Diarrhoea; Headache; Injection site pain; Nausea	FLUX~PFIZER\WYETH~4928132~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050205	02/18/1993	WI	32.0	32		M	12/03/1992	pt recvd flu vax & 72 hrs later devel flu-like sx consisting of nausea, vomiting, joint aches, diarrhea, fever & chills;									Y	10/07/1992	10/10/1992	3	NONE	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient	892351003K	1						1	Arthralgia; Chills; Diarrhoea; Influenza; Nausea; Pyrexia; Vomiting	FLUX~PFIZER\WYETH~4928132~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050206	02/18/1993	WI	36.0	36		F	12/03/1992	pt recvd flu vax & approx 3-4 hrs later noticed redness of the entire upper arm, accompanied by warmth; applied ice to affected area & the reaction subsided;									Y	10/06/1992	10/06/1992	0	NONE	OTH	PVT	Desipramine, Lopressor, lithium, Trazadone, Triampterene	NONE	Depression	~ ()~~~In patient	892351004K	1						1	Vasodilatation	FLUX~PFIZER\WYETH~4928132~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050207	02/18/1993	WI	41.0	41		F	12/03/1992	pt recvd flu vax & devel flu lik sx lasting 24 hrs;									Y	10/14/1992	10/14/1992	0	NONE	OTH	PVT	NONE	NONE		~ ()~~~In patient	892351005K	1						1	Influenza	FLUX~PFIZER\WYETH~4928132~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050208	02/18/1993	WI	43.0	43		F	12/03/1992	pt recvd flu vax 7 approx 4-6 hrs later pt devel flu-like sx consisting of nauasea, weakness, & pains; these sx lasted approx 36 hrs;									Y	10/06/1992	10/06/1992	0	NONE	OTH	OTH	NONE	NONE	pt has chronic fatigue synd	~ ()~~~In patient	892351006K	1						1	Asthenia; Influenza; Nausea; Pain	FLUX~PFIZER\WYETH~4928132~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050209	02/18/1993	WI	68.0	68		F	12/03/1992	pt recvd flu vax & approx 8-9 hrs later, pt exp weakness & faintness, which lasted approx 6-8 hrs;									Y	10/26/1992	10/26/1992	0	NONE	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient	892351007K	1						1	Asthenia; Dizziness	FLUX~PFIZER\WYETH~4928132~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050210	02/18/1993	IN	7.0	7		M	11/30/1992	pt recvd flu vax & approx 5 hrs p/2nd dose devel hives which occurred first @ the inject site (golf ball sized welt), then generalized throughout body w/in an hr; pt devel an ear infection on 30NOV92;									Y	11/21/1992	11/21/1992	0		PVT	PVT	Ventolin inhaler	NONE	pt has asthma & is allergic to Ceclor, Amoxcillin, EES, Ceftin & septra; has asthma & seasonal allergic rhinitis;	~ ()~~~In patient	892351008K	1						1	Injection site hypersensitivity; Injection site mass; Otitis media; Urticaria	FLUX~PFIZER\WYETH~4928213~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050211	02/18/1993	CA				F	12/11/1992	Pt recvd flu vax & approx 1 wk later devel cutaneous vasculitis;				Y					U	11/11/1992	11/17/1992	6		OTH	OTH				~ ()~~~In patient	893011001K	1						1	Leukocytosis; Red blood cell sedimentation rate increased; Vasculitis	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0050212	02/18/1993	IL	56.0	56		F	12/10/1992	pt recvd flu vax & pt exp pain @ the inject site described as toothache-like for 2 months;									U	10/28/1992	10/28/1992	0		PUB	OTH				~ ()~~~In patient	893011002K	1						1	Asthenia; Hypokinesia; Injection site pain; Pain; Injection site pain	FLUX~PFIZER\WYETH~4928232~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~928232~3~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0050213	02/18/1993	MS	61.0	61		F	12/15/1992	pt recvd flu vax & devel an urticarial dermatitis (biopsy confirmed); pt was treated w/Pred;				Y					U	10/30/1992	10/31/1992	1		PUB	PUB				~ ()~~~In patient	893011003K	1						1	Hypersensitivity; Urticaria	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0050214	02/18/1993	SC	72.0			M	12/09/1992	pt recvd flu vax on 3DEC92 & on 4DEC92 devel general muscle stiffness all over body; 5DEC92 exp a fever; by 7DEC92 pt's sx subsided;									Y	12/03/1992	12/04/1992	1		MIL	OTH	Haldol			~ ()~~~In patient	893011004K	1						1	Hypertonia; Pyrexia	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050215	02/18/1993	TX	52.0	52		F	01/04/1993	pt recvd flu vax 24NOV92 & 2DEC92 pt presented w/ a rash described as tiny red spots which enlarged & thickened over face, neck, behind the ears & on lt hand; pt noted purple discoloration of fingers & desquamation of skin; swelling;				Y					Y	11/24/1992	12/02/1992	8		PUB	PUB				~ ()~~~In patient	893011005K	1						1	Dermatitis exfoliative; Face oedema; Pruritus; Rash; Rash maculo-papular; Skin discolouration; Urticaria; Face oedema; Oedema; Pharyngitis; Skin discolouration; Skin disorder	FLUX~PFIZER\WYETH~4928241~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928241~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0050216	02/18/1993	CA	65.0	65		F	12/08/1992	pt recvd flu vax on 23NOV92 & exp severe pain in the deltoid for the next 1-3 days which limited ability to lift arm; pain went away then recurred on 8DEC92;									N	11/23/1992	11/23/1992	0		OTH	OTH				~ ()~~~In patient	893011006K	1						1	Hypokinesia; Pain	FLUX~PFIZER\WYETH~4928235~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050217	02/18/1993	CA	61.0	61		M	11/23/1992	pt recvd flu vax & 48 hrs later pt devel hives which lasted 1 wk;									Y	10/29/1992	10/30/1992	1		OTH	OTH				~ ()~~~In patient	893011007K	1						1	Urticaria	FLUX~PFIZER\WYETH~4928235~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050218	02/18/1993	CA	49.0	49		M	11/23/1992	pt recvd flu vax & 48 hrs later, pt devel hives which lasted for 1 wk;									Y	10/29/1992	10/30/1992	1		OTH	OTH				~ ()~~~In patient	893011008K	1						1	Rash maculo-papular	FLUX~PFIZER\WYETH~4928235~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050219	02/18/1993	CA	44.0	44		F	12/08/1992	pt recvd flu vax & exp pain in the arm of inject which limited ROM; pt took ASA & applied heat & cold to the afflicted area;									U	10/29/1992	11/02/1992	4		OTH	OTH				~ ()~~~In patient	893011009K	1						1	Hypokinesia; Pain	FLUX~PFIZER\WYETH~4928235~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050220	02/18/1993	CA	49.0	49		F	11/23/1992	pt recvd flu vax & pt exp flu-like sx including nausea, vomiting & achiness;									U	10/21/1992	10/23/1992	2		OTH	OTH				~ ()~~~In patient	893011010K	1						1	Chills; Cough; Influenza; Laryngitis; Pyrexia	FLUX~PFIZER\WYETH~4928235~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050221	02/18/1993	CA				U	12/08/1992	pt recvd flu vax & pt exp pain inthe arm of inject, h/a & malaise;									U					OTH	OTH				~ ()~~~In patient	893011011K	1						1	Headache; Malaise; Pain	FLUX~PFIZER\WYETH~4928235~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050255	02/22/1993	GA	37.0	37		F	12/27/1992	30OCT92 low grade temp fever, dizziness, & severe h/a; c/o lt shoulder hurting immed; 4NOV92 while @ work lost motor skills, lt side went numb & lost consciousness; taken to hosp adm & remained in hosp for 7 days; weakness;				Y	Y	7			Y	10/30/1992	10/30/1992	0	NA	PUB	PUB	Prozac	NONE	mitral valve prolapse-allergic to PCN	~ ()~~~In patient	GA93020	1						1	Asthenia; Dizziness; Headache; Hypokinesia; Pain; Paraesthesia; Pyrexia; Syncope	FLUX~PFIZER\WYETH~4928233~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0050259	02/22/1993	MN	63.0	63		F	12/11/1992	25NOV92 devel fever, which was treated effectively w/ASA; 26NOV92 devel chest discomfort & fever; seen by MD 27NOV92 & CXR taken dx w/pneumonia rt lung; tx Amoxicillin x 10 days, Seldane & cough med;				Y					Y	11/16/1992	11/25/1992	9	CXR-pneumonia rt lung; 11DEC92 CXR repeated, but results not known yet;	PUB	PUB	THyroxin	cough w/o fever	hypothyroidism	~ ()~~~In patient	MN93001	1						1	Chest pain; Pneumonia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~2F31149~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0050264	02/22/1993	MT	47.0	46		F	02/01/1993	dx w/GBS; seen beginning 27OCT92 w/stable angina, on 5NOV92 w/Hep B f/u; dx 2NOV92; on 16NOV92 for ETOH abuse;					Y	14			Y	10/26/1992	10/27/1992	1		OTH	PUB	pt recvd Gamma Globulin on 5NOV92;		CHF, alcoholic gastritis;	~ ()~~~In patient	MT93003	1						1	Angina pectoris; Drug dependence; Guillain-Barre syndrome; Hepatitis	FLUX~PFIZER\WYETH~4928204~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0050268	02/22/1993	MT	44.0	44		F	01/29/1993	pain in lt arm p/shot received; didn't sleep that noc; c/o generalized malaise & swollen lt upper arm; given Epi & DPH;				Y					Y	01/06/1993	01/06/1993	0		PUB	PUB		NONE	choleylithiasis/COPD/Lumbar muskuloskeletal dysfunction	~ ()~~~In patient	MT93007	1						1	Injection site oedema; Insomnia; Malaise; Pain	FLUX~PFIZER\WYETH~4928204~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1301T~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0050320	02/25/1993	LA	14.0			M	02/19/1993	encephalitis reported in a pt who recvd fluogen in 1978; encephalitis was concurrent w/mumps; it is not certain fluogen was ever given; pt was hospitalized mumps was confirmed by serology;									U				mumps serology pos;	UNK	UNK	UNK	unk	unk	unk~ ()~~~In patient	20787	1						1	Encephalitis; Sialoadenitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050328	02/25/1993	NY	33.0	33		F	02/19/1993	severe muscle spasm, pain, weakness in lt arm, & base of skull stiff neck; APAP w/Codeine, Dolobid, Parafon forte; Ultra sound heat treatment-neck placed in a collar for whiplash-like sx; pain & inability to sleep on lt side-turn head cont;				Y					N	11/06/1992	11/09/1992	3	x-ray-MRI both no findings;	PVT	PVT	Cipro	NONE	cystic Fibrosis	pt exp stiff neck, muscle spasm radiating from lt arm (site of inject) to base;~ ()~~~In patient		1						1	Hypertonia; Myasthenic syndrome; Nuchal rigidity; Pain	FLUX~PFIZER\WYETH~4928225~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0050334	02/25/1993	FL	4.0			M	02/19/1993	high fever 103 following flu vax;				Y					Y	11/19/1992	11/19/1992	0	NONE	PVT	PVT	Theophylline	asthma	NONE	~ ()~~~In patient		1						1	Pyrexia	FLUX~PFIZER\WYETH~4928223~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0050404	03/01/1993	ID	64.0	64		F	02/03/1993	itching on arms & legs, hive formation on arms & legs & chest; DPH, hydrocortisone cream; Pred used @ different time w/little benefit; Atarax also used;				Y					N	11/05/1992	11/05/1992	0	NA	PUB	PUB	Synthroid, Premarin		PCN allergy	NA~ ()~~~In patient	ID93005	1						1	Pruritus; Urticaria	FLUX~PFIZER\WYETH~4928231~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0049546	03/05/1993	GA	36.0	36		F	03/03/1993	Pt recvd 1st dose of Hep B/DT/flu vax on 1OCT92 & began to feel run-down; 11NOV92 to hosp c/o numbness, difficulty walking; hospitalized to r/o meningitis and/or encephalitis; devel some paralysis then poss GBS; LP showed sl inc protein;			Y	Y	Y	8		Y	U	10/01/1992	11/01/1992	31	No relevant data;	PUB	PUB	Ibuprofen		allergy, phenobarbital; allergy, PCN; congenital nystagmus;	~ ()~~~In patient	WAES93010943	1						2	Guillain-Barre syndrome; Infection; Meningitis; Myelitis; Neuropathy; Paraesthesia; Paralysis; Thinking abnormal; CSF test abnormal; Guillain-Barre syndrome; Infection; Meningitis; Myelitis; Neuropathy; Paraesthesia; Post vaccination syndrome	FLUX~PFIZER\WYETH~4928236~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~MERCK & CO. INC.~1060V~1~~~HEP B (RECOMBIVAX HB)~1|TD~PFIZER\WYETH~4928053~UNK~IM A~~TD ADSORBED (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928236~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEP~MERCK & CO. INC.~1060V~1~IM~~HEP B (RECOMBIVAX HB)~2|TD~PFIZER\WYETH~4928053~UNK~IM~~TD ADSORBED (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0050513	03/05/1993	AR	39.0	39		F	10/25/1992	23OCT92 asthma type attack in middle of noc; 24OCT92 clammy, sweaty feeling, whelpy rash on face, sinus pressure & nasl congestion; 25OCT92 nasal congestion; 26OCT92 sinus drainage, sneezing, chilling;									Y	10/19/1992	10/24/1992	5	NONE	PUB	PUB		week a/dental abscess	allergy to dust & pollen-diabetes	~ ()~~~In patient	AR9265	1						1	Asthma; Chills; Hyperhidrosis; Rhinitis; Sinusitis; Urticaria	FLU3~CONNAUGHT LABORATORIES~2F31097~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0048756	03/08/1993	MN	15.0	15		M		Pt recvd vax 17DEC92 & devel grand mal sz; No further details were provided;				Y					Y	12/17/1992	12/24/1992	7	28OCT92 serum Theophylline 16.1-elevated;	OTH	OTH	Theophylline, Albuterol, Septra, Actifed, Augmentin, allergy shots;		seizure disorder; Retardation; allergy, dust; ALlergy, dogs;	pt exp  sz @ 14 y/o w/Recombivax #1 dose;~ ()~~~In patient	WAES92121418	1						2	Condition aggravated; Convulsion; Condition aggravated; Convulsion; Grand mal convulsion	HEP~MERCK & CO. INC.~1257V~2~~~HEP B (RECOMBIVAX HB)~1|FLU3~CONNAUGHT LABORATORIES~2F31143~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|HEP~MERCK & CO. INC.~1257V~2~IM~~HEP B (RECOMBIVAX HB)~2	USA	Emergency room visit	Influenza
0050560	03/08/1993	KY	52.0	52		F	02/17/1993	had severe reaction that caused inflammation to the nerve; pain was unbearable; blockage of nerve, Pred for several weeks-pain meds;				Y					N	10/13/1992	10/16/1992	3		PUB	PUB		NONE	NONE	~ ()~~~In patient		1						1	Neuritis; Pain	FLUX~PFIZER\WYETH~4928233~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0052089	03/08/1993	NY	21.0	21		M		pt recvd vax on 27AUG92 w/no noted problem; pt recvd 2nd dose of vax 25SEP92 & 28SEP92 was seen in clinic w/generalized aches, weakness & muscle soreness;				Y					U	09/25/1992	09/28/1992	3	28SEP92 Anti-HBs pos;	PVT	OTH				~ ()~~~In patient	WAES92090956	1						1	Asthenia; Hypertonia; Myalgia; Myasthenic syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~MERCK & CO. INC.~1059V~2~IM~~HEP B (RECOMBIVAX HB)~1	USA	Emergency room visit	Influenza
0052805	03/08/1993	MO	36.0	36		M		Pt recvd vax 4NOV92 & w/in 2 hrs of vax pt devel fever, arthralgia & myalgia; sx persisted for 2 days; No further details were provided;									Y	11/04/1992	11/04/1992	0	No relevant data;	PVT	PVT	Tenormin;			~ ()~~~In patient	WAES92110568	1						1	Arthralgia; Coordination abnormal; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~MERCK & CO. INC.~1059V~1~IM~~HEP B (RECOMBIVAX HB)~1	USA		Influenza
0050587	03/09/1993	CA	65.0	65		M		pt recvd flu vax 26NOV90 & 16 days later devel t103.6; 26DEC90 had backache; later was mentally confused w/slurred speech; pt taken to hosp had grand mal sz, swelling of brain, severe dementia, behavior problems, delusions, hallucinations;				Y	Y			Y	N	11/26/1990	12/12/1990	16	cxr, CAT scan, LP; poss herpes simplex;	UNK	UNK				~ ()~~~In patient		1						1	Brain oedema; Confusional state; Delusion; Dementia; Encephalitis; Grand mal convulsion; Hallucination; Infection	FLUX~PFIZER\WYETH~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0050659	03/10/1993	MI	57.0			M	02/19/1993	pt recvd flu vax NOV92 & 1 wk later pt devel a sore throat & cervical lymphadenopathy; 2 wks following vax had fever & chills, & cough; anemic, myalgias;			Y	Y	Y	14			N	11/09/1992	11/16/1992	7	Hemoglobin 8; Sed rate 130; Albumin-2.1; Aklaline Phos mild elevation; SGOT mile elevation; SGPT mild elevation; cult-sputum, blood, urine; muscle biopsy-necrotizing vasculitis of medium arteries; Immune complexes;	PVT	OTH	vasotec	NONE		~ ()~~~In patient	893054003E	1						1	Blood alkaline phosphatase increased; Endocarditis; Hypochromic anaemia; Hypoproteinaemia; Myalgia; Polyarteritis nodosa; Red blood cell sedimentation rate increased; Vasculitis	FLUX~PFIZER\WYETH~4928222~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0050215	03/12/1993	TX	52.0	52		F	12/09/1992	fingers turned purple & skin broke-all face, exp neck & lt eye; neck & cheek as well as lt ear swollen; uvula swollen; sx mostly gone by 14DEC92; took DPH;				Y					Y	11/24/1992	12/09/1992	15	states allergic to iodine but had forgotten;	PUB	PUB	NONE	NONE	Iodine-had forgotten	NONE~ ()~~~In patient	TX93017	1						2	Dermatitis exfoliative; Face oedema; Pruritus; Rash; Rash maculo-papular; Skin discolouration; Urticaria; Face oedema; Oedema; Pharyngitis; Skin discolouration; Skin disorder	FLUX~PFIZER\WYETH~4928241~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928241~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0038712	03/15/1993	CO	51.0	51		F	03/08/1993	pt adm to hosp w/sx of GBS; had sl white cell elevation; fatigue, gait sl abn; myelopathy; tingling in both hands; voice is definitely faint; difficulty swallowing; weakness; polyneuropathy; tachycardia; pain; swelling w/erythema & hardness					Y				Y	11/21/1991	11/21/1991	0	nerve conduction velocity studies showed slowed conduction in the lt facial nerve & a distal conduction block in the lt median nerve; EMG nl;	PVT	PVT	NONE	NONE	hx of borderline diabetes	NONE~ ()~~~In patient		1						2	Guillain-Barre syndrome; Injection site hypersensitivity; Leukocytosis; Myasthenic syndrome; Myelitis; Neuropathy; Paraesthesia; Tachycardia	FLU3~CONNAUGHT LABORATORIES~1821219~2~SC A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0049683	03/15/1993	MA	59.0	59		M	02/05/1993	Pt recvd flu vax & 6 days later devel head cold accompanied by cough & heaviness in the chest; 2-3 days later devel SOB & weakness; taken to hosp dx bronchitis; readmitted on 14DEC92 for pulmonary embolism;				Y	Y	7	Y		Y	10/30/1992	11/05/1992	6		OTH	PUB	NONE	NONE	NONE	~ ()~~~In patient	893064001K	1						2	Asthenia; Bronchitis; Chest pain; Cough; Dyspnoea; Pharyngitis; Pulmonary embolism; Rhinitis; Asthenia; Bronchitis; Chest pain; Cough; Dyspnoea; Pharyngitis; Pulmonary embolism; Rhinitis	FLUX~PFIZER\WYETH~4928230~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928230~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0050793	03/15/1993	IA	11.0	11		M	03/07/1993	severe h/a 3SEP91 AM-PM; vomiting p/MN; seizures 7AM on 4SEP91; coma-death 1225PM on 4SEP91;	Y	09/04/1991							N	08/27/1991	09/03/1991	7	autopsy report concluded that pt died of post vaccinal encephalitis;	PVT	UNK			poss of asthma (allergy to cats)	~ ()~~~In patient		1						1	Coma; Convulsion; Encephalitis; Headache; Vomiting	FLUX~PFIZER\WYETH~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0050841	03/16/1993	IL	68.0			F	03/10/1993	rash, fever, serum sickness, colitus, rash, fever, colitis & serum sickness are reported in an pt who recvd fluogen on 12OCT92; exp rash & fever;					Y	66				10/12/1992	10/14/1992	2		PVT	OTH				~ ()~~~In patient	16529	1						1	Colitis; Pyrexia; Rash; Serum sickness	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0050842	03/16/1993	NY				U	03/10/1993	hemiparesis is reported in a pt poss receiving 1 dose of flu vax; MD was not sure whether recvd Parke-Davis fluogen; pt exp sx w/in 24 hrs of vax;									U					PVT	OTH				~ ()~~~In patient	19629	1						1	Hemiplegia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050844	03/16/1993	MA	44.0	44		F	01/28/1993	Itchy-red lump-out of work sick 2 days;									Y	10/27/1992	10/28/1992	1		PUB	PUB				~ ()~~~In patient	MA9322	1						1	Pruritus; Skin nodule; Vasodilatation; Injection site hypersensitivity; Injection site mass; Malaise; Pruritus	FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0050845	03/16/1993	MA	43.0	43		F	01/28/1993	lt arm from shoulder to elbow-swelled, very red & very hot to touch; burning feeling inside the arm; This started a few hrs p/the shot; approx 10 hrs p/very severe h/a, which lasted about 48 hrs p/shot; tired no energy for a few days p/shot									Y	10/26/1992	10/26/1992	0		OTH	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MA9323	1						1	Asthenia; Headache; Injection site hypersensitivity; Injection site oedema; Pain; Vasodilatation; Asthenia; Headache; Oedema peripheral; Pain; Vasodilatation	FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928230~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0050846	03/16/1993	MA	48.0	48		F	01/27/1993	headache, nausea, low grade temp;									Y	10/28/1992	10/29/1992	1		OTH	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MA9324	1						1	Headache; Nausea; Pyrexia; Headache; Nausea; Pyrexia	FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0050895	03/18/1993	SC	36.0	36		F	10/30/1992	itching @ site of inject (LA) which progressed to face & head; no resp distress noted; redness noted @ inject site; BP 120/70 pulse 100;				Y					U	10/30/1992	10/30/1992	0	NA	PUB	PUB	DPH	NONE	allergy to PCN	~ ()~~~In patient	SC92135	1						1	Injection site hypersensitivity; Pruritus; Tachycardia	FLU3~CONNAUGHT LABORATORIES~2F31171~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0050899	03/18/1993	PA	2.0	2	.8	U		GBS;			Y		Y	60		Y	Y	10/02/1992	10/12/1992	10		PVT	PVT		upper resp infect		NONE~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLUX~PFIZER\WYETH~337934~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0050901	03/18/1993	CO				F	11/09/1992	pt recvd flu vax & pneumovax ins ame arm on 28OCT; on 29OCT had devel cellulitis @ inject site;				Y						10/28/1992	10/29/1992	1	NA	OTH	PVT	Premarin	NONE	NONE	~ ()~~~In patient		1						1	Cellulitis	FLUX~PFIZER\WYETH~4928224~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~320936~1~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0050944	03/22/1993	OH	73.0			F	03/03/1993	pt recvd flu vax & devel psychotic reaction characterized by confusion, agitation,hallucinations & horrifying dreams & required hospitalization & tx w/Haldol;					Y	10			Y				MRI-multiple punctate lesions in brain;	OTH	OTH	UNK			pt exp similar rxn w/90-91 flu vax;~ ()~~~In patient	893067003K	1						1	Abnormal dreams; Agitation; Confusional state; Hallucination; Psychotic disorder	FLUX~PFIZER\WYETH~~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0050948	03/22/1993	MA	51.0	51		F	02/02/1993	immed burning @ site (unlike any other flu vax ever recvd), lasting about 5 min, muscle aches, general malaise, h/a lasting about 36 hrs;									Y	10/26/1992	10/26/1992	0		OTH	PUB	NONE	NONE	NONE	~ ()~~~In patient	MA9325	1						1	Headache; Injection site pain; Malaise; Myalgia	FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050949	03/22/1993	MA	38.0	38		F	01/28/1993	large welt in area of vax & very warm for @ least a wk period of time;									Y	10/27/1992	10/28/1992	1		PUB	PUB			asthma & bronchitis	~ ()~~~In patient	MA9326	1						1	Injection site hypersensitivity; Vasodilatation	FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050950	03/22/1993	MA	57.0	57		F	01/28/1993	large welt in area of vax & very warm for a day, & came down w/flu p/recvd vax;									Y	10/27/1992	10/28/1992	1		PUB	PUB				~ ()~~~In patient	MA9327	1						1	Influenza; Injection site hypersensitivity; Vasodilatation	FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050951	03/22/1993	MA	56.0	55		F	01/28/1993	itchy-red-swelling & warm area of vax;									Y	10/27/1992	10/28/1992	1		PUB	PUB				~ ()~~~In patient	MA9328	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050952	03/22/1993	MA				F	02/02/1993	soreness in upper arm site of inject 24 hrs only some redness & warmth @ site only;									Y	11/05/1992	11/06/1992	1	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MA9329	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050953	03/22/1993	MA	52.0	52		F	02/18/1993	h/a began @ 830 PM day of inject; soreness @ inject site same day;									Y	10/27/1992	10/27/1992	0		PUB	PUB	NONE			~ ()~~~In patient	MA9330	1						1	Headache; Injection site pain	FLUX~PFIZER\WYETH~4928230~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050954	03/22/1993	MA	72.0	71		F	02/02/1993	sore throat, runny nose intermittent chills & aching 3-5 days x 3 episodes this winter;									Y	10/27/1992	10/28/1992	1		PUB	PUB				~ ()~~~In patient	MA9331	1						1	Chills; Myalgia; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0050967	03/22/1993	PA	53.0			M		GBS (severe peripheral neuropathies); pt recvd flu shot 3 wks PTA; pt devel acute onset swelling, rt popliteal fossal-fat necrosis; also devel tingling; not able to support arms wgt, unable to stand, voice is worse, difficulty writing;					Y		Y			10/14/1992	11/02/1992	19		UNK	UNK				~ ()~~~In patient		1						1	Dysphonia; Guillain-Barre syndrome; Hypokinesia; Myasthenic syndrome; Necrosis; Neuropathy peripheral; Oedema; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0051065	03/23/1993	OK	60.0	59		F	02/08/1993	Pt phoned 3-4 wks p/vax was given c/o arm hurting; advised warm compresses & return call if not better; 2FEB93 pt called back-arm still hurting; pt loss of movement in arm where vaxed;									N	11/10/1992	11/11/1992	1	NONE	PUB	PUB	NONE	NONE		NONE~ ()~~~In patient	OK939	1						1	Hypokinesia; Pain	FLU3~CONNAUGHT LABORATORIES~2531171~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0051094	03/24/1993	MI	68.0	68		F	01/22/1993	sore in one spot on shoulder & elbow lt arm; when move arm it hurts, pain when reaching, lost strength; red for 2 wks size of quarter p/receiving shot;									N	10/01/1992				PUB	PUB	High blood pressure meds	NONE	high blood pressure	~ ()~~~In patient	MI93014	1						1	Arthralgia; Injection site hypersensitivity; Myalgia; Myasthenic syndrome; Pain	FLUX~PFIZER\WYETH~4928231~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0051099	03/24/1993	MI	75.0	75		F	12/21/1992	no local reaction no fever/chills & both swollen knees; some nausea but no vomiting;				Y					Y	12/03/1992	12/07/1992	4	NONE	PUB	PUB	NONE	NONE	Chronic arthritis	pt exp rxn in 1990 @ 73 y/o flu w/#1 dose;~ ()~~~In patient	MI93019	1						1	Nausea; Osteoarthritis	FLUX~PFIZER\WYETH~4928244~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0051100	03/24/1993	MI	78.0	77		M	12/21/1992	c/o generalized weakness & malaise, nausea & sore throat; evaluated by MD; had s/s of URI;				Y					U	11/10/1992	11/10/1992	0	no lab work done;	OTH	PUB	heart meds HTB & antihypertensive meds;		hypertension	~ ()~~~In patient	MI93020	1						1	Asthenia; Malaise; Nausea; Pharyngitis	FLUX~PFIZER\WYETH~4928244~UNK~IM L~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0051272	03/29/1993	TX	67.0			M		suspected post influenza vax encephalitis w/myelitis/ensuing motor neuron paresis; upon discharge, pt was able to ambulate/speech improved;					Y		Y	Y		10/12/1992	10/22/1992	10	neg urine & blood cult; carotid doppler & echo cardiogram nl; MRI brain stem nl; Thyroid profile nl; spinal tap nl;	UNK	UNK	Voltaren, Vasotec & Vicodin		hypertension, arthritis	~ ()~~~In patient		1						1	Encephalitis; Myelitis; Paralysis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0051411	04/01/1993	OK	44.0			U		Pt recvd vax 4NOV93 & from 20-28NOV had flu-like sx; cont to feel tired, but worked as scheduled; 19JAN sent home, t100, sore throat, & achy; 24JAN devel weakness w/pain & numbness in lower extremities, not able to urinate dx pneumonia					Y					11/04/1992	01/19/1993	76		UNK	UNK				~ ()~~~In patient		1						1	Asthenia; Dyspnoea; Influenza; Myalgia; Neuropathy; Paraesthesia; Pneumonia; Urinary retention	FLUX~PFIZER\WYETH~4928218~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0051412	04/01/1993	IN	64.0	64		F		GBS 2 wks p/vax on respirator 6 mos; pneumonia; vibration either markedly diminished or absent below the knees & wrists; strength dec; back discomfort, ascending paralysis, resp paralysis & multiple pulmonary complications & infections;					Y					12/09/1991	12/23/1991	14		UNK	UNK				~ ()~~~In patient		1						1	Dyspnoea; Guillain-Barre syndrome; Infection; Neuropathy; Paraesthesia; Paralysis; Pneumonia; Stupor	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0051424	04/01/1993	CA	40.0	40		F	11/13/1992	Approx 1 wk post vax pt had onset joint pain, swelling hands lower legs & tingling both hands; problems intermittent since evaluate w/MD; rx diuretic, Motrin				Y					N	10/22/1992	10/23/1992	1	ANA-sl elevation; ASMA (eelvated); LDH 206; EMG abn;	PVT	PVT	NONE	NONE	bilateral carpal tunnel under eval	NONE~ ()~~~In patient		1						1	Antinuclear antibody; Arthralgia; Blood lactate dehydrogenase increased; Laboratory test abnormal; Oedema peripheral; Paraesthesia	FLUX~PFIZER\WYETH~4928245~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0051425	04/01/1993	CA	51.0	51		F	11/25/1992	pt felt nausea, passed out & hit head; awoke feeling that could not move hands for a few seconds; sustained cut to head; slept intermittantly for next 36 hrs w/lightheadedness; seen by MD 5 days post head trauma; MD felt not re to vax;				Y					Y	11/05/1992	11/14/1992	9	CAT Scan 24NOV92 results not known; chem panel (reports normal) per pt;	PVT	PVT	Provera/Estrace	NONE	allergy-Codeine (hives);	pt exp flu like @ 41 w/flu vax;~ ()~~~In patient		1						1	Dizziness; Hypokinesia; Injury; Nausea; Syncope; Tinnitus	FLUX~PFIZER\WYETH~4928245~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0051426	04/01/1993	CA	35.0	35		F	11/11/1992	10NOV92 c/o feeling unwell, loose BM x 15, vomited x 1, nausea; resolved over next few day-MD consulted by pt suggested illness was viral; 12NOV92 sl soreness of neck;				Y					Y	11/02/1992	11/10/1992	8	NONE	OTH	OTH	Augmentin	previous sinusitis on med >1 wk	hayfever	NONE~ ()~~~In patient		1						1	Diarrhoea; Infection; Malaise; Nausea; Neck pain; Vomiting	FLUX~PFIZER\WYETH~4928245~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0049507	04/07/1993	NY	10.0	10		M	04/03/1993	fevers (for wks-approx 5-6 wks); swollen painful joints (cont currently); rash (brief); severe fatigue (partially resolved); gradual 20 lb weight loss while ill (acute phase);				Y				Y	N	11/18/1992	11/21/1992	3	xrays; blood test of various kinds cont currently;	PVT	PVT	Bedovent	conjunctivitus	asthma & hayfever	NONE~ ()~~~In patient		1						2	Arthralgia; Asthenia; Gait disturbance; Headache; Hypokinesia; Neck pain; Osteoarthritis; Pain; Arthralgia; Asthenia; Osteoarthritis; Pyrexia; Rash; Weight decreased	FLU3~LEDERLE LABORATORIES~337935~1~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|FLU3~LEDERLE LABORATORIES~049507~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~2	USA	Disabling	Influenza
0051690	04/08/1993	CT				M	02/21/1993	c/o lt eye closing; took DPh & eye opened a little; skin rough under lt eye went to MD given PRed & cream; had flu shot about 2 1/2 wks a/this occurence;				Y						10/22/1992	11/03/1992	12		PUB	UNK				~ ()~~~In patient		1						1	Eye disorder; Skin disorder	FLU3~CONNAUGHT LABORATORIES~2F31171X~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0051691	04/08/1993	CT	37.0			F	02/22/1993	sl fever, h/a, complete weakness in bed 1 wk went to MD had a mild bacterial infect in blood had a kidney transplant; flu shot given 14OCT92;				Y					U	10/14/1992	11/08/1992	25		PUB	PUB			hx of kidney transplant	~ ()~~~In patient		1						1	Asthenia; Headache; Pyrexia; Sepsis	FLUX~PFIZER\WYETH~4928147~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0051692	04/08/1993	CT				F	02/22/1993	2 wks p/flu shot got a very bad cold & had to go to MD;				Y					Y	10/31/1992	11/23/1992	23		PUB	PUB				~ ()~~~In patient		1						1	Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~2F31171X~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0051693	04/08/1993	CT	50.0			F		localized itching @ site of inject; flu shot given on Wednesday had itching on Friday;									Y	12/02/1992	12/04/1992	2		PUB	PUB				~ ()~~~In patient		1						1	Pruritus	FLUX~PFIZER\WYETH~2F31171X~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0051694	04/08/1993	CT	73.0	72		M		mild soreness of jaw-generalized weakness had a bad reaction in 1976 (swine flu) pt jaw closed @ that time; no permanent disability;									Y	10/08/1992	10/26/1992	18		PUB	UNK				~ ()~~~In patient		1						1	Asthenia; Myalgia	FLUX~PFIZER\WYETH~4928147~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0051695	04/08/1993	CT				F		c/o sore throat for 2 days then backaches & h/a;									U	10/21/1992	10/29/1992	8		UNK	UNK				~ ()~~~In patient		1						1	Back pain; Headache; Pharyngitis	FLUX~PFIZER\WYETH~4928147~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0051696	04/08/1993	CT				F	02/21/1993	c/o cold for 2 wks was taking ATB; still didn't feel any better also sore throat had devel;									U	10/07/1992	10/26/1992	19		PUB	UNK				~ ()~~~In patient		1						1	Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4928147~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0051697	04/08/1993	CT				F	02/21/1993	c/o sore arm w/muscular aches for 2 wks;									U	10/21/1992				PUB	UNK				~ ()~~~In patient		1						1	Myalgia	FLUX~PFIZER\WYETH~4928147~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0051794	04/12/1993	WA	66.0	65		F	02/25/1993	arm so sore could not raise it above head all musces got sore, terrible h/a; next day OK;				Y					Y	10/01/1992	10/01/1992	0		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	WA93872	1						1	Headache; Hypokinesia; Myalgia	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0051802	04/12/1993	WA	48.0	48		F	03/23/1993	2 days p/flu shot, lethargic & chilled; 72 hrs later had cough & flu for 2 wks;									Y	10/20/1992	10/22/1992	2	NONE	OTH	PVT	unk	NONE	NONE	~ ()~~~In patient	WA93880	1						1	Chills; Cough; Influenza; Somnolence	FLU3~CONNAUGHT LABORATORIES~2F31132~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0051822	04/12/1993	CO	6.0	6		M	10/20/1992	cluster of vesicles just below vax site; reddened base but no induration; tender to pressure; no drainage; no other rash inject site lt arm;									Y	10/02/1992	10/06/1992	4	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain	FLUX~PFIZER\WYETH~4928217~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0051907	04/19/1993	OH	74.0			F	03/03/1993	pt recvd vax & 12 days later, pt devel a psychotic reaction characterized by confusion, agitation, hallucinations, & horrifying dreams; had dec appetite & sleep; believed had inc physical strength & extra sensory powers;					Y	10			Y				MRI white matter disease;	PVT	OTH	UNK	unk		pt had similar reaction the previous yr when recvd vax rxn required a brief hosp~ ()~~~In patient	893067002K	1						1	Abnormal dreams; Anorexia; Cerebrovascular disorder; Confusional state; Delirium; Delusion; Hallucination; Psychotic disorder	FLUX~PFIZER\WYETH~4908198~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0050178	04/22/1993	NY	63.0	63		F	04/19/1993	onset of severe pain lt shoulder & lt arm approx 10 hrs p/inject of vax; pain becam progressively worse/intense & extended to lt hand w/numbness to 3 middle fingers; still numbness in fingers & head (pain);				Y					N	10/20/1992	10/21/1992	1	NA	PVT	PVT	Synthroid, Intal;	NONE	Asthma	NA~ ()~~~In patient		1						2	Pain; Paraesthesia; Headache; Hypoaesthesia; Injection site pain; Pain	FLUX~PFIZER\WYETH~~7+~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928241~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0052112	04/26/1993	WV	39.0			M		Pt recvd vax & MD reported that Enalapril stopped working following flu vax;										08/06/1991	08/06/1991	0	No relevant data;	UNK	UNK	Cap Prilosec		palsy, cerebral	~ ()~~~In patient	WAES91110853	1						1	Drug interaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0052113	04/26/1993	MI	31.0			F	04/12/1993	Pt recvd flu vax & 6 days later pt was hospitalized for pancreatitis, hepatitis, & cholecystitis;					Y				U					OTH	OTH	Valproic acid, carbamazepine;	UNK	Lennox-Gestaut Syndrome;	~ ()~~~In patient	893105001K	1						1	Abdominal pain; Jaundice cholestatic; Pancreatitis; Vomiting	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0052125	04/26/1993	OR	31.0	31		F	01/20/1993	2 days p/flu vax given 6NOV c/o shaky, weakness & cramping legs only no fever, little nausea; sx diarrhea 2 wks later; c/o cont leg weakness; r/o connective tissue disease;				Y						11/04/1992	11/06/1992	2	blood tests WNL;	PUB	PUB		NONE	seasonal spring hayfever	~ ()~~~In patient	OR935	1						1	Asthenia; Diarrhoea; Muscle spasms; Myasthenic syndrome; Nausea; Tremor	FLUX~PFIZER\WYETH~4928231~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0052133	04/26/1993	SD	31.0	31		F	04/13/1993	devel hives which broke open & wept; also had resp & gastro-Intestinal sx; seen by MD				Y					Y	10/16/1992	10/20/1992	4		PVT	UNK	NONE		diabetes-type I insullin dependant hx of allergies PCN, Codeine	~ ()~~~In patient	SD93012	1						1	Gastrointestinal disorder; Respiratory disorder; Urticaria	FLUX~PFIZER\WYETH~4928222~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0052157	04/26/1993	IL	30.0			M	04/16/1993	pt devel urticarial rash on hands, face, thighs about 6 hrs p/vax;									Y	10/15/1992	10/15/1992	0	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Urticaria	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0052171	04/27/1993	VA	35.0			F	04/21/1993	fine, raised red rash scattered predominately over upper torso;									Y	10/28/1992	10/29/1992	1	NA	PVT	PVT	NONE	NONE	No known allergies	NONE~ ()~~~In patient		1						1	Rash maculo-papular	FLU3~PARKE-DAVIS~00292P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0050212	05/03/1993	WI	56.0	56		F	12/10/1992	pt c/o sore arm @ site of inject; has been seeing MD;				Y					N	10/28/1992			NONE	PUB	PUB			NONE	~ ()~~~In patient		1						2	Asthenia; Hypokinesia; Injection site pain; Pain; Injection site pain	FLUX~PFIZER\WYETH~4928232~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~928232~3~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0052346	05/03/1993	WI	75.0	75		F	12/04/1992	few hrs p/vax pt had swelling @ shoulder & inject site; c/o pain, aching & redness; no temp; called MD & rx w/APAP w/Codeine but no pain relief; 2 hrs later went to ER & recvd pain med inject & blood work; dx w/infect;				Y					Y	11/13/1992	11/13/1992	0		PUB	PUB		NONE	slipped disc & pneumonia-infection complication-JUNE	NONE~ ()~~~In patient		1						1	Infection; Injection site oedema; Myalgia; Oedema; Pain; Vasodilatation	FLUX~PFIZER\WYETH~4928232~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0101V~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0052351	05/03/1993	WI	59.0	59		F	12/02/1992	has had sore arm since inject; had nausea & vomiting w/muscle aches; will see MD on 7DEC re: pain in arm;									N	10/28/1992	10/29/1992	1		PUB	PUB		NONE	NONE	~ ()~~~In patient		1						1	Myalgia; Nausea; Pain; Vomiting	FLUX~PFIZER\WYETH~4928232~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0101V~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0052352	05/03/1993	WI	79.0	79		F	01/28/1993	Pt recvd vax on 15OCT93 & has had a sore arm since then sought care from MD who gave exercises to do;									U	10/15/1992	10/15/1992	0	UNK;	PUB	PUB	ANti Hypertensive	NONE	hypertension, arthritis; hx of small stroke	~ ()~~~In patient		1						1	Myalgia	FLU3~PARKE-DAVIS~00782P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0052353	05/03/1993	WI	56.0	56		F	12/22/1992	pt became nauseated, flushed, clammy, dizzy, visual changes-blurred vision; also became pale; lasted for a few minutes then would ease up then sx would reappear lasted for 1/2 hrs to 1 hr;									Y	12/16/1992	12/16/1992	0	NONE	PUB	PUB	L-Thyroxine, Metoprolol, APAP, Warfarin, oxazipron, Ibuprofen;	NONE	sulfa; aneurysm-brain; stroke, hypertension, hypothyroidism;	~ ()~~~In patient		1						1	Amblyopia; Dizziness; Hyperhidrosis; Nausea; Pallor; Vasodilatation	FLU3~PARKE-DAVIS~00982P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0052354	05/03/1993	WI	72.0	72		F	12/02/1992	Pt phoned about 18NOV c/o that rt arm was swollen red & painful site of flu immun;										10/23/1992			NONE	PUB	PVT	UNK	NONE	NONE	pt exp redness & induration @ 66 y/o cholera #1;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~4928231~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0052355	05/03/1993	WI	58.0	58		F		inject site surrounding area became red itchy not warm; rx-Atarax, Elison oint;									Y	12/01/1992				PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus	DT~LEDERLE LABORATORIES~324901~UNK~IM~LA~DT ADSORBED (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928226~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0046502	05/05/1993	MA	41.0	41		F	02/02/1993	Pt recvd vax & exp pain & swelling in the arm & soreness under the arm;									Y	10/14/1992	10/15/1992	1		PUB	PUB	NONE	NONE		~ ()~~~In patient	893076003K	1						2	Myalgia; Oedema peripheral; Pain	FLUX~PFIZER\WYETH~4928222~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0047279	05/05/1993	NY	75.0	75		M	02/02/1993	Pt recvd flu vax & the next day devel GI problems & coughing for the next 2 wks;									Y	10/15/1992	10/16/1992	1		PUB	PUB	NONE	NONE		~ ()~~~In patient	893069027K	1						2	Cough; Gastrointestinal disorder	FLUX~PFIZER\WYETH~4928235~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0047287	05/05/1993	MA	79.0			F	02/02/1993	Pt recvd flu vax & that evening had chills, perspiration, & bad h/a; next devel pain from the back of the knees to calves; slept all day 15OCT92;									Y	10/13/1992	10/13/1992	0		PUB	PUB	NONE	NONE	hlth dept	~ ()~~~In patient	893076001K	1						3	Chills; Headache; Hyperhidrosis; Pain; Somnolence	FLUX~PFIZER\WYETH~4928230~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA		Influenza
0047291	05/05/1993	MA	67.0	67		F	02/02/1993	Pt recvd flu vax & exp puffy eyes, lost voice, sore throat & laryngitis & felt tired;									Y	11/22/1992	11/27/1992	5		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	893069026K	1						2	Asthenia; Dysphonia; Face oedema; Laryngitis; Pharyngitis	FLUX~PFIZER\WYETH~4928230~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0048026	05/05/1993	MA	66.0	66		M	02/02/1993	pt recvd flu vax & became achy, tired & had chills, & a h/a;									Y	10/21/1992	10/22/1992	1		PUB	PUB	NONE	NONE		~ ()~~~In patient	893069021K	1						2	Asthenia; Chills; Headache; Myalgia	FLUX~PFIZER\WYETH~4928230~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0048027	05/05/1993	MA	65.0	64		F	02/02/1993	Pt recvd flu vax & found to have viral conjunctivitis; prescribed ATB eye drops, but they did not help;									Y	10/28/1992	11/04/1992	7		PUB	PUB		unk		~ ()~~~In patient	893076002K	1						2	Conjunctivitis; Infection	FLUX~PFIZER\WYETH~4928230~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0048029	05/05/1993	WA				F	02/02/1993	pt recvd flu vax & devel rash & itching of extremities & scalp; aslo had a h/a for 1 wk;									Y	10/27/1992	10/27/1992	0		PUB	PUB	NONE	NONE	asthma	~ ()~~~In patient	893069029K	1						2	Headache; Pruritus; Rash	FLUX~PFIZER\WYETH~4928230~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0048030	05/05/1993	MA	66.0	66		F	02/02/1993	Pt recvd flu vax & 7 days later exp arthralgias & chills but no fever; also had a sore throat;									Y	10/14/1992	10/17/1992	3		PUB	PUB		NONE		~ ()~~~In patient	893069028K	1						2	Arthralgia; Chills; Pharyngitis	FLUX~PFIZER\WYETH~4928230~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0049059	05/05/1993	MA	55.0	55		F	02/02/1993	pt recvd flu vax & 12 days later exp feeling of pins & needles in both extremities accompanied by intermittent pain; 27OCT92 pain inc accompanied by swelling;				Y					N	10/08/1992	10/20/1992	12	Lab data nl;	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	893069022K	1						2	Insomnia; Oedema; Pain; Paraesthesia; Vasodilatation; Oedema; Pain; Paraesthesia; Arthralgia; Oedema; Pain; Paraesthesia	FLUX~PFIZER\WYETH~4928230~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0455V~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|MMR~MERCK & CO. INC.~0455V~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~2|FLUX~PFIZER\WYETH~4928230~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|MMR~MERCK & CO. INC.~0455V~1~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~3	USA	Emergency room visit	Influenza
0049086	05/05/1993	MA	72.0	72		M	02/02/1993	pt recvd flu vax & devel aches, chills, pain, fever, different taste, in the mouth; pt went to the ER because of cont fever (99) on 22OCT92; seen by MD 27OCT92; cont w/low fever 16NOV92;				Y					N	10/06/1992	10/11/1992	5		PUB	PUB	Tegretol, Phenobarbital	NONE		~ ()~~~In patient	893076004K	1						2	Chills; Dysgeusia; Myalgia; Pain; Pyrexia; Vasodilatation; Chills; Dysgeusia; Myalgia; Pain; Pyrexia	FLUX~PFIZER\WYETH~4928222~7+~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928222~7+~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0049280	05/05/1993	MA	79.0	79		M	01/25/1993	pt recvd flu vax & exp a h/a;									Y	10/16/1992	10/16/1992	0		PUB	PUB	NONE			~ ()~~~In patient	893070010K	1						2	Headache; Headache	FLUX~PFIZER\WYETH~4928221~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928221~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0049281	05/05/1993	MA	39.0	39		F	02/02/1993	pt recvd flu vax & exp burning in the throat, nasal congestion, watery eyes & coughing up phlegm;									Y	10/15/1992	10/16/1992	1		PUB	PUB	NONE	UNK	high blood pressure, arthritis, back spasm;	~ ()~~~In patient	893067004K	1						2	Cough; Lacrimal disorder; Pharyngitis; Rhinitis; Cough; Lacrimal disorder; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4928227~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928227~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0049282	05/05/1993	MA	41.0	41		F	02/02/1993	pt recvd flu vax & devel redness (approx the size of an orange) @ the inject site; THe area was warm to touch; also felt dizzy p/inject;									Y	12/02/1992	12/02/1992	0		OTH	PUB	NONE			~ ()~~~In patient	893070011K	1						2	Dizziness; Injection site hypersensitivity; Vasodilatation; Dizziness; Injection site hypersensitivity; Vasodilatation	FLUX~PFIZER\WYETH~4928235~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928235~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0049283	05/05/1993	NH	56.0	55		F	01/25/1993	Pt recvd flu vax & felt stinging pain followed by warmth & erythema @ the inject site which lasted 4 days; had no fever;									Y	11/26/1992	11/26/1992	0		OTH	PUB	NONE	NONE	osteoarthritis	~ ()~~~In patient	893069025K	1						2	Injection site hypersensitivity; Injection site pain; Vasodilatation; Injection site hypersensitivity; Injection site pain; Vasodilatation	FLUX~PFIZER\WYETH~0008081501~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0049474	05/05/1993	MA	67.0	67		F	02/02/1993	pt recvd flu vax & 2 days later devel aches & pains in joints, fever (less than 100), h/a & sinus drainage; treated w/ATB for sinusitis & recovered in 1 mon;									Y	10/28/1992	10/30/1992	2		PUB	PUB	NONE			~ ()~~~In patient	893067001K	1						2	Arthralgia; Headache; Lacrimal disorder; Myalgia; Pyrexia; Rhinitis; Arthralgia; Headache; Pyrexia; Sinusitis	FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0049503	05/05/1993	MA	76.0	76		M	02/02/1993	Pt recvd flu vax & devel a sore throat & a runny nose; sx persisted for 10 days; pt saw MD who felt pt had a sinus infection;				Y					Y	10/21/1992	10/21/1992	0		OTH	PUB	NONE			~ ()~~~In patient	893069030K	1						2	Pharyngitis; Rhinitis; Sinusitis; Pharyngitis; Rhinitis; Sinusitis	FLUX~PFIZER\WYETH~4928221~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928221~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0049605	05/05/1993	MA	70.0	70		F	02/02/1993	pt recvd flu vax & exp muscle stiffness, aching & pain which lasted 1 wk; also had cold sx;									Y	10/26/1992	10/26/1992	0		PUB	OTH	NONE			~ ()~~~In patient	893069023K	1						2	Hypertonia; Hypokinesia; Myalgia; Pain; Pharyngitis; Rhinitis; Hypertonia; Myalgia; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0049684	05/05/1993	MA	52.0	52		M		Pt recvd flu vax & several hrs later had 1 episode of emesis; felt unwell w/minimal fatigue, chest heaviness, non-productive cough; might have bronchitis or pneumonia;				Y					Y	10/30/1992	10/30/1992	0	cxr, urine, blood, TB test wer all neg or nl;	PUB	PUB	NONE	NONE	hx of repeated pneumonia bronchitis	pt recvd flu vax~ ()~~~In patient	893070012K	1						2	Asthenia; Bronchitis; Chest pain; Condition aggravated; Cough; Malaise; Pneumonia; Vomiting; Asthenia; Bronchitis; Chest pain; Cough; Malaise; Pneumonia; Vomiting	FLUX~PFIZER\WYETH~4928230~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928230~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0049710	05/05/1993	MA	86.0	86		F	02/02/1993	pt recvd flu vax & devel a red rash which lasted 1 wk;									Y	10/01/1992	10/01/1992	0		PUB	PUB	NONE	NONE		~ ()~~~In patient	893069024K	1						2	Rash; Rash	FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4923230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0049731	05/05/1993	UT	81.0	81		F	01/26/1993	Pt recvd flu vax 9OCT92 & 32 to 48 hrs later, exp swelling of the ankles & wrists & severe muscle pain in all limbs making it difficult to walk or sit; couldn't lift arms & could not dress self; pt recvd a 5 day course of Pred w/resolution;				Y					N	10/09/1992	10/11/1992	2		PUB	PVT	NONE	NONE	pt has hayfever	~ ()~~~In patient	893042011K	1						2	Asthenia; Myalgia; Myasthenic syndrome; Oedema peripheral; Pain; Arthritis; Hypokinesia; Myalgia; Osteoarthritis	FLUX~PFIZER\WYETH~4928224~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928224~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0050844	05/05/1993	MA	44.0	44		F	03/17/1993	pt recvd vax & devel itchy red lump @ inject site; pt was sick for 2 days;									Y	10/27/1992	10/28/1992	1		PUB	PUB	NONE	unk		~ ()~~~In patient	893081001K	1						2	Pruritus; Skin nodule; Vasodilatation; Injection site hypersensitivity; Injection site mass; Malaise; Pruritus	FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0050845	05/05/1993	MA	43.0	43		F	03/17/1993	pt recvd flu vax & a few hrs later noted swelling of the arm from the shoulder to the elbow accompanied by redness & warmth; had a burning feeling inside the arm; 10 hrs later devel h/a which lasted for 48 hrs; felt tired for few days;									Y	10/26/1992	10/26/1992	0		PUB	PUB	NONE	NONE		~ ()~~~In patient	893081003K	1						2	Asthenia; Headache; Injection site hypersensitivity; Injection site oedema; Pain; Vasodilatation; Asthenia; Headache; Oedema peripheral; Pain; Vasodilatation	FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928230~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0050846	05/05/1993	MA	48.0	48		F	03/17/1993	pt recvd flu vax & exp h/a, nausea, & fever;									Y	10/28/1992	10/29/1992	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	893081002K	1						2	Headache; Nausea; Pyrexia; Headache; Nausea; Pyrexia	FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0052404	05/05/1993	NY	38.0			F		Pain behind lt ear, then pt devel high cervical transverse myelitis; lt Brown Sequard Syndrome								Y		11/16/1992	02/07/1993	83	MRI- inflamm of high cervical spinal cord;	UNK	UNK			allergies-grass, trees, pollens, caine drugs;	~ ()~~~In patient		1						1	Myelitis; Neuritis; Neuropathy; Pain; Abdominal pain; Chest pain; Headache; Multiple sclerosis; Myasthenic syndrome; Myelitis; Optic atrophy; Paraesthesia	HEP~SMITHKLINE BEECHAM~1021A4~2~IM~~HEP B (ENGERIX-B)~1|FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|HEP~SMITHKLINE BEECHAM~1021A4~2~IM A~~HEP B (ENGERIX-B)~2	USA	Disabling	Influenza
0052406	05/05/1993	WI	29.0			F		devel GBS during 37th wk of pregnancy; 2 wks p/flu vax (given 13NOV92) ascending paralysis-resp failure intubated slow resolution;					Y		Y			11/13/1992	11/27/1992	14		UNK	UNK	Human insulin;		Insulin dependent diabetic & pregnant; LMP 10MAR92 EDC 20DEC92 induced due to evolving necrologic weakness delivered 2DEC92;	~ ()~~~In patient		1						1	Abnormal labour; Apnoea; Asthenia; Guillain-Barre syndrome; Paralysis	FLUX~PFIZER\WYETH~4928147~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0053281	05/05/1993	PA	66.0			M	02/11/1993	Pt recvd flu vax in DEC92 pt exp flu-like sx, dizziness & imbalance; pt was admitted to the hosp in an encephalopathic state;					Y		Y		N	12/01/1992				OTH	OTH	UNK	UNK	pt exp flu-like sx following influenza vax last yr;	~ ()~~~In patient	893043001K	1						1	Coordination abnormal; Dizziness; Encephalopathy; Influenza	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0053282	05/05/1993	NY	20.0	20		F	01/08/1993	Pt recvd flu vax & devel inflammation, induration, swelling, & warmth @ the site of inject;				Y					Y	01/06/1993	01/06/1993	0	NONE	PVT	PVT	NONE	NONE		~ ()~~~In patient	893020001E	1						1	Injection site inflammation; Injection site mass; Injection site oedema; Vasodilatation	FLUX~PFIZER\WYETH~4928227~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0053283	05/05/1993	CA	24.0	24		F	01/11/1993	Pt recvd flu vax & devel redness @ the inject site, joint pain in the shoulder & SOB;									Y	01/11/1993	01/11/1993	0		PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient	893020002E	1						1	Arthralgia; Dyspnoea; Injection site hypersensitivity	FLUX~PFIZER\WYETH~4928225~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053284	05/05/1993	CA	56.0			F	01/05/1993	Pt recvd flu vax & devel alopecia; pt reports had same reaction last year when recvd flu shot OCT91;									U	10/12/1992	12/25/1992	74		PVT	OTH	Slobid, Alupent inhaler, Atrovent inhaler, Vanceril inhaler, Synthroid;	asthma	pt has asthma;	pt exp alopecia @ 55 w/flu;~ ()~~~In patient	893020003E	1						1	Alopecia	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053285	05/05/1993	MA	75.0	74		M	01/20/1993	pt was hospitalized w/in the last 6 months for kidney disease recvd flu vax on 30OCT92; 6 wks after the pt was found to have antibodies to Hep C & elevated liver enzymes;									U	10/30/1992	01/14/1993	76		OTH	OTH	UNK	UNK	pt had kidney disease;	~ ()~~~In patient	893042009K	1						1	Hepatic function abnormal; Laboratory test abnormal	FLUX~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053286	05/05/1993	OH	41.0	41		F	01/06/1993	Pt recvd flu vax on 4NOV92 & pt exp SOB described as an asthma attack 3 hrs later;				Y					N	11/04/1992	11/04/1992	0	WBC 9.7; CXR nl;	PUB	PVT	Multivitamin	NONE	pt is allergic to codeine; pt had a flu shot last year & exp vomiting & diarrhea;	~ ()~~~In patient	893042010K	1						1	Asthma; Dyspnoea	FLUX~PFIZER\WYETH~4928147~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0053288	05/05/1993		30.0	30		M	02/03/1993	Pt recvd flu vax & 25 minutes later exp allergic reaction consisting of coughing, chest tightness & SOB;									U	11/19/1992	11/19/1992	0		OTH	OTH	UNK	UNK	pt does not have asthma or allergy to eggs;	~ ()~~~In patient	893044009K	1						1	Asthma; Cough; Dyspnoea; Headache; Hypersensitivity	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053289	05/05/1993	GA	80.0	80		F	01/25/1993	Pt recvd flu vax & immed afterward pt exp redness & itching @ the inject site;									Y	09/18/1992	09/18/1992	0	Lot# 4928213 was tested & found to be satisfactory;	PVT	PVT	Zantac, Baby ASA, Halcion, Tranxene, Deponit Patch, Berocca plus, Verelan, Klor-con, Carafate, Lanoxin, Lozol, Nitroglycerin spray, Quinine sulfate;	arthritis		~ ()~~~In patient	893065001K	1						1	Injection site hypersensitivity; Pruritus	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053290	05/05/1993	AL	77.0	76		F	01/25/1993	Pt recvd flu vax immed afterward exp redness & itching @ the site of inject;									Y	09/19/1992	09/19/1992	0	pt is allergic to ASA, sulfa, Dimetapp, Tetracycline, & Bronkepherin;	PVT	PVT	Isoptin, Maxaire Inhaler, Uniphyl, Azmacort inhaler, Biaxin, Pred;	allergic rhinitish, bronchitis	pt is allergic to ASA, Sulfa, Dimetapp, Tetracycline, Bronkepherin;	~ ()~~~In patient	893065002K	1						1	Injection site hypersensitivity; Pruritus	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053291	05/05/1993	FL				F	03/03/1993	pt recvd flu vax in OCT92; On 28FEB93 pt devel the flu;									U	10/01/1992	02/28/1993	150		PUB	PUB				~ ()~~~In patient	893065003K	1						1	Drug ineffective; Influenza	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053311	05/05/1993		31.0			M	01/28/1993	pt recvd flu vax pt exp arm pain;									Y					OTH	OTH	NONE	unk		~ ()~~~In patient	893076005K	1						1	Pain	FLUX~PFIZER\WYETH~4928230~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053312	05/05/1993		84.0	84		F	02/02/1993	Pt recvd flu vax & the following wk pt lifted arm while getting dressed & felt sharp pain @ a site well above the inject site; arm then became black & blue & swollen;									Y	10/13/1992	10/20/1992	7		OTH	OTH	Diuretic	UNK	pt has heart problems;	~ ()~~~In patient	893076006K	1						1	Ecchymosis; Oedema peripheral; Pain	FLUX~PFIZER\WYETH~4928230~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053313	05/05/1993		72.0			M	02/02/1993	pt recvd flu vax & devel sore throat & 3 wks later had a bad cold which lingered;									U					OTH	OTH	NONE	UNK	pt has hypertension	~ ()~~~In patient	893076007K	1						1	Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053317	05/05/1993	MA	52.0			F	03/18/1993	Pt recvd flu vax & 830PM had a h/a; also had soreness @ inject site;									Y		10/27/1992			OTH	OTH	NONE	UNK	NONE	~ ()~~~In patient	893083001K	1						1	Headache; Injection site pain	FLUX~PFIZER\WYETH~4928230~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053318	05/05/1993	MA	72.0			F	03/18/1993	Pt recvd flu vax & exp sore throat, runny nose, chills, aching of the limbs for 3-5 days;									Y		10/28/1992			OTH	OTH	NONE	UNK		~ ()~~~In patient	893083002K	1						1	Chills; Myalgia; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4928230~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053319	05/05/1993	MA	51.0			F	03/18/1993	Pt recvd vax & exp immed burning which lasted about 5 mins; also had msucle aches, general malaise, h/a lasting bout 36 hrs;									Y		10/26/1992			OTH	OTH	NONE	UNK		~ ()~~~In patient	893083003K	1						1	Headache; Malaise; Myalgia; Pain	FLUX~PFIZER\WYETH~4928230~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053320	05/05/1993	MA	38.0			F	03/18/1993	pt recvd flu vax & devel large welt in the area of the inject which was warm;									Y		10/28/1992			OTH	OTH	NONE	UNK	pt has asthma & bronchitis	~ ()~~~In patient	893083004K	1						1	Injection site hypersensitivity; Vasodilatation	FLUX~PFIZER\WYETH~4928230~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053321	05/05/1993		57.0			F	03/18/1993	Pt recvd vax & devel a welt in the area of inject accompanied by warmth; reaction lasted a day; pt devel the flu;									Y		10/28/1992			OTH	OTH	NONE	UNK		~ ()~~~In patient	893083005K	1						1	Drug ineffective; Infection; Influenza; Injection site hypersensitivity; Vasodilatation	FLUX~PFIZER\WYETH~4928230~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053322	05/05/1993					F	03/18/1993	pt recvd flu vax & exp pain, redness, & warmth @ the inject site which lasted for 24 hrs;									Y		11/06/1992			OTH	OTH	NONE	UNK		~ ()~~~In patient	893083006K	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLUX~PFIZER\WYETH~4928230~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053323	05/05/1993		56.0			F	03/19/1993	pt recvd flu vax & devel redness, swelling, warmth & pruritus @ the inject site;									Y		10/28/1992			OTH	OTH	NONE	UNK		~ ()~~~In patient	893083007K	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~4928230~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0052636	05/14/1993	CO	60.0			F	04/12/1993	3inch diameter red, hot raised area of lt deltoid; aches; used ice for 3 to 4 days; observed 3NOV92; area 2 inch pink area, no lump or induration @ pt what pt states was inject site;									N	10/13/1992	10/13/1992	0	NA	PUB	PUB	NA	good health		~ ()~~~In patient	CO93031	1						1	Injection site hypersensitivity; Injection site mass; Myalgia; Vasodilatation	FLUX~PFIZER\WYETH~4928224~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053151	05/24/1993	IN	42.0			F	05/11/1993	Chronic intense pain from shoulder to 7-8 down arm; This was the 1st time pt has been vaxed for influenza; pt stated that the pain started immed p/receiving the shot; pt exp limited movement in that arm, difficulty lifting arm overhead;								Y	N		10/10/1992			OTH	OTH				~ ()~~~In patient	23591	1						1	Hypokinesia; Insomnia; Pain	FLU3~PARKE-DAVIS~01772P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Disabling	Influenza
0053275	05/26/1993	MI	16.0	16		U		asthma exacerbation responded to pred burst & inc of asthma inhalers;				Y	Y	2			Y	12/30/1992	12/31/1992	1		PVT	PVT	Proventil, Intal	NONE	asthma	~ ()~~~In patient		1						1	Condition aggravated	FLUX~PFIZER\WYETH~4928222~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0053496	06/01/1993	OR	73.0	73		F	05/25/1993	pt recvd vax w/local pain x 36 hrs; resolved; followed by paresthesias& weakness;				Y					Y	10/27/1992	10/29/1992	2	NCV proximal ulnar neuropathy; EMG; MRI neg of prox area;	PVT	PVT	DIgoxin	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Injection site pain; Neuropathy; Paraesthesia	FLUX~PFIZER\WYETH~4928109~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0053506	06/01/1993	CA	59.0	59		M		Rt eye swelling, myalgias, hepatic decompensation, flushing, inc abdo discomfort, bloating, icterus, drowsiness, nasuea, ascites;									Y	11/16/1992	11/19/1992	3	PT 14.5 dec; IWR 1.5; va post bile;	PVT	PVT	Lomotil, Periactin, Tamoxifen, Sandostatin, Maxide;	carcinoid synd	carcinoid synd	NONE~ ()~~~In patient		1						1	Ascites; Condition aggravated; Face oedema; Hepatocellular damage; Jaundice; Myalgia; Somnolence; Urine analysis abnormal	FLUX~PFIZER\WYETH~4928225~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0049059	06/03/1993	MA	55.0	55		F		pt recvd vax on 8OCT92 & 12 days p/vax pt exp a feeling of pins &needles in both upper extremities accompanied by intermittent pain; 27OCT92 pain inc & was accompanied by swelling;				Y					N	10/08/1992	10/20/1992	12	No relevant data;	PUB	PUB	NONE			~ ()~~~In patient	WAES93031533	1						3	Insomnia; Oedema; Pain; Paraesthesia; Vasodilatation; Oedema; Pain; Paraesthesia; Arthralgia; Oedema; Pain; Paraesthesia	FLUX~PFIZER\WYETH~4928230~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0455V~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|FLUX~PFIZER\WYETH~4928230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|MMR~MERCK & CO. INC.~0455V~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~2|FLUX~PFIZER\WYETH~4928230~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|MMR~MERCK & CO. INC.~0455V~1~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~3	USA	Emergency room visit	Influenza
0053550	06/03/1993	CA	70.0			M		Bell's palsy is reported in pt 1 day p/receiving fluogen; No further med info is available;										11/01/1991	11/01/1991	0	N/S	UNK	UNK			N/S	~ ()~~~In patient	924091021	1						1	Facial palsy	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0053551	06/03/1993	TX	55.0			M		dizziness is reported in pt who recvd fluogen; dizziness appeared 3 days p/fluogen inject was given; pt has a h/o hypertenison, which is well controlled; pt recovered from dizziness;										10/08/1992	10/11/1992	3	NS	UNK	UNK			hypertension	~ ()~~~In patient	924092018	1						1	Dizziness	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0053552	06/03/1993	TX	55.0			M		pt recvd fluogen vax & became dizzy 2 days p/vax; Pt's BP was not checked; pt has a h/o hypertension;										10/08/1992	10/11/1992	3	N/S;	UNK	UNK			pt has hypertension;	~ ()~~~In patient	924092017	1						1	Dizziness	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053553	06/03/1993	MT	41.0			F		pt recvd fluogen vax & exp bell's palsy; pt has exp bell's palsy's in the past; 1980 & in 1984;										10/26/1992	10/30/1992	4	n/s	UNK	UNK			pt had bell's palsy attack 12 yrs ago;	~ ()~~~In patient	924092060	1						1	Eyelid ptosis; Facial palsy	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053554	06/03/1993	OH	30.0			M		numbness in legs is reported in a pt receiving 1 dose of fluogen for influenza prophylaxis; pt recently had back surgery; this case was reported by pt's wife, who is hlth care professional;										11/15/1992	11/19/1992	4		UNK	UNK			pt recently had back surgery;	~ ()~~~In patient	924092100	1						1	Paraesthesia	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053555	06/03/1993	FL				U		double vision is reported int pt receiving fluogen vax; pt exp sx following administration of fluogen therapy;													tests performed by physician were neg;	UNK	UNK				~ ()~~~In patient	924092095	1						1	Diplopia	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053556	06/03/1993					F		h/a, dizziness & disorder in ears are reported in pt receiving 1 dose of fluogen; pt described ear disorder as ears feeling full; sx treated w/Darvocet;										11/13/1992	11/14/1992	1		UNK	UNK	Darvocet; Propoxyphene Napsylate			~ ()~~~In patient	924092102	1						1	Dizziness; Ear disorder; Headache	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053557	06/03/1993	MI	54.0			M		Pt recvd fluogen vax & devel bell's palsy on lt side & later both sides of face were affected; approx 5-6 wks p/fluogen administration; pt has h/o hypertension; pt went to ER 5 wks p/vax w/poss facial nerve paralysis on lt side of face;				Y						11/13/1992	12/16/1992	33		UNK	UNK	Dyazide, Isoptin, Lanoxin, Procardia SR, Hydrochlorothiazide, Verapamil, Digoxin, Nifedipine;		h/o hypertension;	~ ()~~~In patient	19287	1						1	Facial palsy	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0053558	06/03/1993	CA	44.0			F		pt recvd fluogen vax 1DEC92 & 28DEC92 pt went to MD office w/ache in lt arm, hands tingling & body numb from walking, numbness in face (but could talk), pressure in chest but not difficulty breathing;					Y	8				12/01/1992	12/23/1992	22		UNK	UNK				~ ()~~~In patient	20264	1						1	Asthenia; Chest pain; Gait disturbance; Guillain-Barre syndrome; Myalgia; Myelitis; Paraesthesia	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0053559	06/03/1993	NC	34.0			F		Pt recvd vax 28OCT93 & felt different, flushed, tingle from head to toes, panic-like feeling immed p/vax was administered; MD reported pt exp flu like sx (sore throat, fever, cough w/in 30 mins of administration; pt fatigued & myalgia w/ach										10/28/1992	10/28/1992	0	nl EEG during 3rd wk of JAN93;	UNK	UNK				~ ()~~~In patient	21478	1						1	Asthenia; Convulsion; Influenza; Myalgia; Paraesthesia; Pharyngitis; Pyrexia; Stupor	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053560	06/03/1993	GA	40.0			F		Pt recvd vax 1FEB93 & exp peripheral neuropathy & numbness & tingling in hands & feet 1 mo later;										11/01/1992	12/01/1992	30		UNK	UNK	Estrogen patch; Calcium tablets; multivitamins;		pt is MD; pt had 1st dose of Merck's experimental hepatitis a vax in SEP92; 2nd dose was administered in OCT92;	~ ()~~~In patient	22626	1						1	Neuropathy peripheral; Paraesthesia	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053663	06/07/1993	NY	66.0	66		M	06/04/1993	clinical & biochemical flare-up of chronic hepatitis B liver disease lasting 2 & 6 months consecutively these devel w/in 1 wk p/vax; recovery was associated w/spontaneous conversion;									Y	11/18/1992	11/25/1992	7	ALT climbed from 2 to 45x upper limit of nl, Bilirubin to 7mg/dl;	PUB	PUB	NONE	chronic persistent hep B	NONE	NONE~ ()~~~In patient	BA93027	1						1	Condition aggravated; Hyperbilirubinaemia	FLUX~PFIZER\WYETH~492820L~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0053690	06/08/1993	PA	71.0	71		M	06/01/1993	pos for Hep C virus p/vax; 14DEC91 pt donated blood to red cross 29OCT90, 1MAR91, 21MAY91, 7AUG91, w/o post result; pt notified false pos test result;			Y						N	10/20/1991	10/29/1991	9	Antibody to Hepatitis C virus EIA (anti-HCV);	PVT	PVT	NONE	NONE	NONE	pt exp rxn 29OCT91 & 73 w/flu;~ ()~~~In patient		1						1	Laboratory test abnormal	FLU3~LEDERLE LABORATORIES~337909~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Life Threatening	Influenza
0053722	06/09/1993	PA	70.0	70		M	01/11/1993	lips swollen 3 time nl size welts on arm; 4OCT92 to ER treated w/Pred & DPH;				Y					Y	10/03/1992	10/04/1992	1		PUB	PUB	Inderal daily	NONE		~ ()~~~In patient	PA92350	1						1	Face oedema; Urticaria	FLU3~CONNAUGHT LABORATORIES~2F31149~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0053793	06/09/1993	PA	49.0	49		F	11/13/1992	nausea for approx 1 wk;									Y	11/04/1992	11/09/1992	5	NONE	PUB	UNK	Synthroid, Thynimine, Nicronase	NONE	asthma, bornchitis	NA~ ()~~~In patient	PA92421	1						1	Nausea	FLU3~PARKE-DAVIS~2731156~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0054036	06/18/1993	CA	56.0	56		F	05/06/1993	myalgias, malaise, arthralgias, stiff hands 1 wk post vax; cont for 4 wks treated w/motrin;									N	10/14/1992	10/21/1992	7	ANA 1:1280; Rheumatoid factor 1:400; sed rate 99; dx w/rheumatoid arthritis;	PVT	PVT	Maxzide, Potassium	hypertension	tetanus	~ ()~~~In patient		1						1	Antinuclear antibody; Arthralgia; Arthritis; Arthropathy; Laboratory test abnormal; Malaise; Myalgia; Red blood cell sedimentation rate increased	FLUX~PFIZER\WYETH~4928225~3~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0054092	06/21/1993	NJ	65.0	65		F	06/09/1993	frozen shoulder; pain both knees, hips, arms, extreme weakness; heavy nosebleed while asleep 5NOV92;									N	10/16/1992	10/26/1992	10	xrays knee, pelvis, shoulder 20NOV; 17MAR MRI spine Lumbar (moderate spinal stenosis L4-5, 3-4; 21APR Bone scan (nl);	PUB	PUB	synthroid		hypothyroid	~ ()~~~In patient		1						1	Arthralgia; Asthenia; Epistaxis; Hypokinesia; Pain	FLU3~CONNAUGHT LABORATORIES~2F31099~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0054257	06/28/1993	CA	75.0	75		M	06/22/1993	excruciating pain @ vax site that spread down to arm & over shoulder; numbness & tingling in extremities; burning of vision & 2 episodes of violent tremors; shoulder pain; no sleep; neuritis; convuls ?, weakness of arm & leg, ringing in ear				Y					N	11/23/1992	11/25/1992	2	xrays/MRI/EMG	PVT	UNK	Ectrin	NONE				1						1	Amblyopia; Injection site pain; Insomnia; Myalgia; Neuritis; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~2F31118~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0054475	07/06/1993	TX				U	10/14/1992	Pt recvd flu vax & 4 days later the pt claims to have devel GBS; This report was recvd as result of legal proceedings; No further info is known;									U					OTH	OTH	UNK	UNK		~ ()~~~In patient	893173001K	1						1	Guillain-Barre syndrome	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0054509	07/06/1993	MS	47.0	47		F		huge local reaction to vax 5x6 cm area of erythema & induration;				Y					Y	05/14/1993	05/15/1993	1		PVT	PVT		laceration		~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass	FLUX~PFIZER\WYETH~4938011~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0054542	07/07/1993	CA	21.0	21		M		h/a, body aches, flu like sx;				Y					U	10/14/1992	10/16/1992	2	NONE	MIL	MIL				~ ()~~~In patient		1						1	Headache; Influenza; Myalgia	FLUX~PFIZER\WYETH~4928239~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0054575	07/12/1993	AZ	69.0	69		F	11/30/1992	broke out in red rash, individual, looking like pus underneath; then break & spread till area all red; no fever; was seen by MD of hosp put on Pred;				Y					N	11/12/1992	11/22/1992	10		OTH	PUB	Insulin, Haldol	NONE	diabetic	~ ()~~~In patient	AZ9320	1						1	Rash; Rash pustular	FLUX~PFIZER\WYETH~4928235~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0054662	07/15/1993	FL	20.0			M		pt recvd vax on 17MAY93 & noticed bilateral calf cramping & weakness on 1JUN93; weakness progressed until by 4JUN was unable to walk; had some milder upper extremity weakness too; c/o upper respiratory-like sxs;					Y					05/17/1993	06/01/1993	15	CSF stains/cultures/cell count/protein/glucose= nl; Brain & cervical MRI x/for pansinusitis; Thyroid function-nl; ANA-nl; Nerve conduction studies suggesting polyneuropathy w/some aspects of GBS;	UNK	UNK	PPD			~ ()~~~In patient		1						1	Guillain-Barre syndrome; Hypertonia; Hypokinesia; Myasthenic syndrome; Neuropathy; Pharyngitis; Rhinitis; Sinusitis	ADEN~PFIZER\WYETH~4928031~UNK~PO~MO~ADENOVIRUS (TYPE 4, NO BRAND NAME)~1|ADEN~PFIZER\WYETH~4928030~UNK~PO~MO~ADENOVIRUS (TYPE 7, NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~2J31137~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~CONNAUGHT LABORATORIES~2L41074~UNK~SC~~MENINGOCOCCAL (MENOMUNE)~1|OPV~PFIZER\WYETH~667M3~UNK~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~1	USA	Hospitalisation	Influenza
0054754	07/21/1993	PA	29.0			F	07/09/1993	severe lt lower abo pain, weight loss & over all weakness are reported in pt who recvd fluogen; pt underwent a biopsy & colonoscopy which revealed some type of organism; felt faint while driving & woke up in the hospital;				Y	Y					11/11/1992			biopsy & colonoscopy revealed some organism;	PVT	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	25164	1						1	Abdominal pain; Asthenia; Dizziness; Infection; Syncope; Weight decreased	FLU3~PARKE-DAVIS~01772P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0054804	07/23/1993	NY	62.0			M		INR inc; pt increased; pt has been maintained on Coumadin dose for 5 mos w/no change; recvd flu vax 1 wk prior;										10/15/1992	10/22/1992	7	INR 2.7-3.11; PT 19.8;	UNK	UNK				~ ()~~~In patient		1						1	Laboratory test abnormal; Prothrombin level increased	FLU3~CONNAUGHT LABORATORIES~~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0054959	07/27/1993	LA	16.0	16		M	03/19/1993	pt exp hives & asthma six to eight (6-8) hrs p/receiving flu vax;				Y					Y	10/03/1991	10/03/1991	0		PVT	PVT	Humulin L & R	diabetes mellitus	pt had no hx of egg allergy; has diabetes mellitus;	~ ()~~~In patient	893110001K	1						1	Asthma; Urticaria	FLU3~PARKE-DAVIS~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0054960	07/27/1993	MA	60.0			F	06/01/1993	pt recvd vax & each time exp sl tingling of lips & a vague headache; on f/u recvd 1JUN93, pt indicated that recovered;									Y	10/01/1991	10/01/1991	0		OTH	OTH	UNK	unk	pt reported a similar reaction the prev year (se report # 891017007B);	pt reported a similar reaction the previous year;~ ()~~~In patient	893160002K	1						1	Headache; Paraesthesia oral	FLU3~PARKE-DAVIS~~2~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0054961	07/27/1993	IL	66.0			M	04/29/1993	pt recvd vax & 1 wk later began to experience joint stiffness in both shoulders which has persisted; ROM of arms has been severely limited; MD feels has developed a progressive bilateral brachial plexopathy;				Y					N					OTH	OTH	Proventil inhaler	UNK	asthma, type II diabetic	~ ()~~~In patient	893126001K	1						1	Arthropathy; Hypokinesia; Neuropathy	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0055044	08/02/1993	OR	55.0			F		pt recvd vax 13OCT92 & 12 to 14 hrs following vax pt devel shakiness, fever, & weakness; it was also noted that devel a red raised 6 by 5 area @ the inject site which was tender to touch; By 23OCT92 the vax area had dec to 3 by 5; c/o h/a;									U	10/13/1992	10/13/1992	0	No relevant data;	OTH	OTH	NONE			~ ()~~~In patient	WAES92101035	1						1	Asthenia; Headache; Injection site hypersensitivity; Injection site mass; Injection site pain; Pyrexia; Tremor	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0101V~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0055045	08/02/1993	CT	59.0	59		F		Pt recvd vax 23OCT92 & 7 hrs p/vax devel a fever of 102, aches & chills; 24OCT92 devel nausea; On 25OCT92 devel swelling & redness leading under the arm w/a couple of striations as well as pain @ the inject site; 26OCT92 noted a hard, red									Y	10/23/1992	10/23/1992	0	No relevant data;	PVT	PVT	NONE		allergy, environmental; allergy, epinephrine; allergy, Lidocaine; allergy, xylocaine;	~ ()~~~In patient	WAES92101157	1						1	Chills; Injection site pain; Myalgia; Nausea; Oedema peripheral; Pyrexia; Skin striae; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~2F31150~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0055052	08/02/1993	CA	18.0	18		F		pt recvd vax 19NOV92 & 19NOV92 lt arm became swollen & sore, it was red, moderately tender & hot to touch; could not move arm; there was no fever;									Y	11/19/1992	11/19/1992	0	No relevant data;	OTH	OTH	Loestrin Fe;			~ ()~~~In patient	WAES92120272	1						1	Hypokinesia; Myalgia; Oedema peripheral; Pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1301T~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0055065	08/05/1993	CO	52.0			F	07/20/1993	pt recvd vax 24OCT90; neurological sx began in early NOV; pt was seen in the hosp ER on 7NOV90; 14NOV90 was admitted to hosp given a dx of GBS;					Y	73			U	10/24/1990	11/14/1990	21		PVT	PVT	UNK	UNK		~ ()~~~In patient	893207006K	1						1	Guillain-Barre syndrome; Neuropathy	FLUX~PFIZER\WYETH~4908201~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0055199	08/12/1993	OR	66.0	66		F	08/03/1993	immed intense pain @ inject site, rt deltoid pain, weakness & paresthesia since that time;				Y					N	10/25/1991	10/25/1991	0	plain xray, MRI of arms & neck, low scan  all neg;	PVT	PVT	NONE	NONE	sulfa & caffeine; no medical conditions;	~ ()~~~In patient		1						1	Injection site pain; Myalgia; Myasthenic syndrome; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~2165S~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0055211	08/13/1993	DC	68.0			M		rash area of inject-cellulitis; cellulitis lt thigh;					Y						12/16/1992			UNK	UNK	NONE		NKDA	~ ()~~~In patient		1						1	Cellulitis; Injection site hypersensitivity	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0055382	08/19/1993	FL	19.0			F	08/16/1993	approx 1 hrs p/receiving meningococcal vax & flu vax c/o chest heaviness exam revealed scattered wheezes in upper lung fields; treated w/Epi;									Y	06/08/1993	06/08/1993	0	NONE	MIL	MIL	Motrin	NONE	NONE	~ ()~~~In patient		1						1	Asthma; Chest pain	FLU3~CONNAUGHT LABORATORIES~2J31137~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~CONNAUGHT LABORATORIES~2L41074~1~SC~~MENINGOCOCCAL (MENOMUNE)~1	USA		Influenza
0055463	08/24/1993	NY	74.0			M		resp distress, febrile, inc WBC admitted to hosp;					Y					10/16/1992	10/17/1992	1	blood count;	UNK	UNK			pt had renal failure & was on dialysis	~ ()~~~In patient		1						1	Dyspnoea; Leukocytosis; Pyrexia	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0055519	08/26/1993	MD	52.0	52		F	07/06/1993	small, hard lump under skin p/immun progressively got larger; approx 1 month ago became larger; got head on it & daughter opened it on 2JUL; puss expressed; today raised area approx 10 x 10mm lt arm; lt of smallpox scar;									Y	10/22/1992	07/02/1993	253	NONE	PUB	PUB	NONE	NONE	NONE	pt exp small, hard lump under skin w/pus @ 46 y/o w/flu vax;~ ()~~~In patient	MD93027	1						1	Injection site abscess; Injection site mass	FLUX~PFIZER\WYETH~4928146~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0055549	08/27/1993	AL	63.0	63		F	08/23/1993	extreme muscle pain w/in 2 hrs of immun; muscle pain & burning sensation is acute & debilitating w/no relief; various MD have made various dx & varied treatments w/no relief;			Y					Y	N	10/01/1992	10/01/1992	0	elevated sed rate & CRP & VIBC	PVT	OTH	Estrogen, Thyroid;	NONE	NONE	NONE~ ()~~~In patient		1						1	Asthenia; Hypokinesia; Insomnia; Laboratory test abnormal; Myalgia; Neck pain; Pain; Red blood cell sedimentation rate increased; Myalgia; Pain; Red blood cell sedimentation rate increased	FLUX~PFIZER\WYETH~00682P~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~312944~UNK~~LA~PNEUMO (PNU-IMUNE)~1|FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~PFIZER\WYETH~~UNK~~~PNEUMO (PNU-IMUNE)~2	USA	Life Threatening,Disabling	Influenza
0055699	09/01/1993	PA	40.0			M	10/28/1992	consumer reports that husband was given pnu-imune & flu vax @ the same site about 1 inch apart on the same day; pt exp redness & pain @ inject site; also feels weak, lightheaded w/impaired concentration; Egg allergy as a child;									U	10/26/1992	10/26/1992	0	NA	OTH	OTH	NA		egg allergy as a child;	NA~ ()~~~In patient	920357101	1						1	Asthenia; Dizziness; Injection site hypersensitivity; Injection site pain; Thinking abnormal; Asthenia; Dizziness; Injection site hypersensitivity; Injection site pain; Thinking abnormal	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0055702	09/01/1993	NC				F	10/28/1992	1 of 3 pts (out of 200 pts vaxed) who exp a red swollen arm; the edema extended below the elbow; treatment included APAP Q 4 hrs & warm soaks @ the site; pt recovered;				Y					Y	10/01/1992			NA	OTH	OTH	NA	healthy		NA~ ()~~~In patient	920363302	1						1	Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~332933~1~~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0055703	09/01/1993	NC				F	10/28/1992	1 of 3 pts (out of 200 pts vaxd) who exp a red swollen arm; the edema extended below the elbow; treatment included APAP Q 4 hrs & warm soaks @ the site; pt recovered;				Y					Y	10/01/1992			NA	OTH	OTH	NA	healthy		NA~ ()~~~In patient	920363303	1						1	Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~332933~1~~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0055704	09/01/1993	IN	45.0			F	10/26/1992	pt recvd vax 16OCT92 & an inject site reaction @ the pnu-imune site; seen in office on 19OCT-inject site reaction was 3cm in diameter & consisted of redness, swelling, hematoma & numbness @ the site;				Y					Y	10/16/1992			NONE	PVT	PVT	NA	healthy	asthma, chronic bronchitis	NA~ ()~~~In patient	920363801	1						1	Injection site haemorrhage; Injection site hypersensitivity; Injection site oedema; Paraesthesia	FLUX~PFIZER\WYETH~4928228~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~318920~1~IM A~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0055705	09/01/1993	WI				U	11/02/1992	pt recvd vax & approx 3 days p/immun, pt exp pain in legs; hopsitalized 3-4 days; dx radiculoneuropathy in 1 leg (knee); pt recovered;					Y	4			Y	10/01/1992	10/01/1992	0	NA	PVT	PVT	NA	NA	NA	NA~ ()~~~In patient	920372601	1						1	Neuropathy; Pain	FLUX~PFIZER\WYETH~4928213~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~318917~1~IM~~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0055717	09/01/1993	NY	76.0	76		M	12/03/1992	pt revd vax & exp inject site reaction @ the pne-imune site which began w/in 24 hrs p/vax; reaction was localized; red & hot to the touch- lasted a few days; not seen by MD;									Y	10/29/1992	10/29/1992	0	NONE	PVT	PVT	Tetracycline	healthy;	allergic to PCN	NONE~ ()~~~In patient	920392701	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PARKE-DAVIS~00982P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~332933~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0055718	09/01/1993	SC	50.0	50		F	12/07/1992	1 of 2 pts who w/in 48 hrs postimmunization exp cellulitis @ the pnu-immune inject site; react included 2cm of induration, erythema & a red horizontal streak in the middle of the inject site; treated w/Amoxicillin x 7 days;				Y					Y	11/16/1992	11/18/1992	2	NONE	OTH	OTH	Prilosec-premarin; Voltaren;	healthy;	allergy to Ceclor;	unk~ ()~~~In patient	920393401	1						1	Cellulitis; Injection site hypersensitivity; Injection site mass; Skin striae	FLUX~PFIZER\WYETH~4928230~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~318920~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0055549	09/07/1993	AL	64.0			F	09/02/1993	extreme muscle pain & burning sensation are reported in a pt who recvd fluogen vax w/pnu-imune; pt had no significant medical hx;			Y					Y	N	10/01/1992	10/01/1992	0	sed rate-elevated;	PVT	OTH	Estrogen, Thyroid	NONE	NONE	NS~ ()~~~In patient	26167	1						2	Asthenia; Hypokinesia; Insomnia; Laboratory test abnormal; Myalgia; Neck pain; Pain; Red blood cell sedimentation rate increased; Myalgia; Pain; Red blood cell sedimentation rate increased	FLUX~PFIZER\WYETH~00682P~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~312944~UNK~~LA~PNEUMO (PNU-IMUNE)~1|FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~PFIZER\WYETH~~UNK~~~PNEUMO (PNU-IMUNE)~2	USA	Life Threatening,Disabling	Influenza
0055821	09/07/1993	MI	59.0	59		M	07/25/1993	pt recvd vax 5OCT92 & devel neurological s/s T11-T12 26OCT92; MRI's, LP lab etc; dx acute transverse myelitis w/profound neurological residue; deficit still present 10 months later;								Y	N	10/05/1992	10/25/1992	20	MRI x 4; LP lab;	PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient	MI93120	1						1	Myelitis; Neuropathy	FLUX~PFIZER\WYETH~4928136~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0047446	09/08/1993	TX	6.0	6		M	11/18/1992	pt exp syncope w/in 1 minute p/vax; pt was also perspiring; recovered w/in a few minutes; observed for 15-30 minutes & then sent home; no meds were given;				Y					Y	10/28/1992	10/28/1992	0	NONE	PVT	PVT	NONE	healthy		NA~ ()~~~In patient	920381201	1						2	Hyperhidrosis; Syncope	FLU3~LEDERLE LABORATORIES~335915~1~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~2	USA	Emergency room visit	Influenza
0055699	09/08/1993	PA	40.0			M	10/28/1992	consumer reports that her & husband recvd vax the same day & exp redness & pain @ inject site; also feels weak, lightheaded w/impaired concentration; Egg allergy as a child;									U	10/26/1992	10/26/1992	0	NA	OTH	OTH	NA		egg allergy as a child	NA~ ()~~~In patient	920357101	1						2	Asthenia; Dizziness; Injection site hypersensitivity; Injection site pain; Thinking abnormal; Asthenia; Dizziness; Injection site hypersensitivity; Injection site pain; Thinking abnormal	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0055945	09/08/1993	IN				F	07/24/1992	consumer reports that pt was immunized 1NOV92 & became sick & could hardly breathe; treated w/ATB since November & @ time of this report, still has difficulty breathing;									N	11/01/1991			NA	OTH	OTH	NA		had flu shot a few years prior	NA~ ()~~~In patient	920276401	1						1	Dyspnoea; Malaise	FLU3~LEDERLE LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0055946	09/08/1993	LA	11.0	11		M	09/17/1992	w/in 4 hrs p/vax pt exp generalized urticaria which would come & go, but never totally resolve; mother reported that during the noc, pt had low grade fever & urticaria worsened; tx included DPH/Calamine lotion & cold compresses;				Y					Y	09/14/1992	09/14/1992	0	NONE	PVT	PVT	Pred	nephrotic synd since 5 yrs of age;	pt recvd prev dose of flu-imune OCT91	~ ()~~~In patient	920326701	1						1	Pyrexia; Urticaria	FLU3~LEDERLE LABORATORIES~335915~2~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0055947	09/08/1993	TX				F	10/12/1992	w/in 24 hrs p/vax 9OCT92 pt exp an allergic reaction; devel welts over entire body; seen in ER 10OCT; presented to ER on 11OCT & was hospitaized; pt had severe itching @ time of hospitalization;				Y	Y				U	10/09/1992	10/10/1992	1	unk	PVT	PVT	NA	healthy	unk if pt is allergic to eggs;	NA~ ()~~~In patient	920348001	1						1	Hypersensitivity; Pruritus; Urticaria	FLU3~LEDERLE LABORATORIES~335915~UNK~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation	Influenza
0055948	09/08/1993	PA				U	10/19/1992	1 of 5 pts who had a reaction following vax; pt exp a rash & numbness of the lips immediately following vax;				Y					U	10/01/1992	10/01/1992	0	NA	PVT	PVT	NA	NA	NA	NA~ ()~~~In patient	920351501	1						1	Paraesthesia oral; Rash	FLU3~LEDERLE LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0055949	09/08/1993	PA				U	10/19/1992	11 of 5 pts who had a reaction following vax; pt exp a rash & numbness of the lips;				Y					U	10/01/1992	10/01/1992	0	NA	PVT	PVT	NA	NA	NA	NA~ ()~~~In patient	920351502	1						1	Paraesthesia oral; Rash	FLU3~LEDERLE LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0055950	09/08/1993	PA				U	10/19/1992	1 of 5 pts who had a reaction following vax; pt exp a rash & numbness of the lips;				Y					U	10/01/1992	10/01/1992	0	NA	PVT	PVT	NA	NA	NA	NA~ ()~~~In patient	920351503	1						1	Paraesthesia oral; Rash	FLU3~LEDERLE LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0055951	09/08/1993	PA				U	10/19/1992	1 of 5 pts who had a reaction following vax; pt exp numbness of the lips w/in 24 hrs p/vax; no other sx reported;				Y					U	10/01/1992	10/01/1992	0	NA	PVT	PVT	NA	NA	NA	NA~ ()~~~In patient	920351504	1						1	Paraesthesia oral	FLU3~LEDERLE LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0055952	09/08/1993	PA				U	10/19/1992	1 of 5 pts who had a reaction following vax; pt exp a rash & erythema @ the site of inject w/in 24 hrs p/vax;				Y					U	10/01/1992	10/01/1992	0	NA	PVT	PVT	NA	NA	NA	NA~ ()~~~In patient	920351505	1						1	Injection site hypersensitivity; Rash	FLU3~LEDERLE LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0055953	09/08/1993	KS	70.0			M	10/22/1992	pt vaxed & 2 days later had a fever of 103-104 w/no other sx; hospitalized 5 days @ time of this report; meningitis r/o;					Y	5			N	10/01/1992	10/01/1992	0	blood & urine-neg;	PVT	PVT	NA	healthy	wife was also vaxed from the same vial & has exp no reaction to date 22OCT92;	NA~ ()~~~In patient	920355001	1						1	Pyrexia	FLU3~LEDERLE LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation	Influenza
0055955	09/08/1993	GA	51.0			F	10/28/1992	plaintiff alleges that as a result of vax 23OCT90, pt was hospitalized on 3NOV90 w/dx of post vaccination focal encephalitis @ time of litigation OCT92; reportedly has permanent brain damage w/severe vision problems;					Y			Y	N	10/23/1990	11/03/1990	11	NA	OTH	OTH	NA	NA	NA	NA~ ()~~~In patient	920357801	1						1	Delirium; Encephalitis; Visual disturbance	FLU3~LEDERLE LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation,Disabling	Influenza
0055956	09/08/1993	VA	63.0	63		F	10/28/1992	pt vaxed on 26OCT92 & w/in 24 hrs pt devel blisters @ inject site; pt is afebrile; seen in office o 28OCT; tx included topicort gel;				Y					U	10/26/1992	10/27/1992	1	no cultures;	PVT	PVT	Tagamet, Ansaid, Ogen	healthy	PCN allergy, Gastritis, Arthritis, menapause;	NONE~ ()~~~In patient	920363201	1						1	Injection site hypersensitivity	FLU3~LEDERLE LABORATORIES~335917~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0055957	09/08/1993	AZ	60.0			F	11/17/1992	consumer devel an itchy rash following vax; rash devel on hips, rt side of stomach, across the lower back & lasted for 3 wks;									U	10/28/1992			NA	OTH	OTH	NA	NA	NA	NA~ ()~~~In patient	920378601	1						1	Pruritus; Rash	FLU3~LEDERLE LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0055959	09/08/1993	TX				F	11/18/1992	pt exp tenderness & inflammation @ inject site (deltoid) for 1 month; pt hands & arms had a cold sensation, treated w/Amoxicillin x 10 days w/no improvement; arm became more painful; dx muscle inflammation;				Y					U	10/01/1992	10/01/1992	0	NA	PVT	PVT	NONE	healthy	NONE pt recvd flu vax lat yer (1991) w/no problems;	NA~ ()~~~In patient	920381301	1						1	Injection site inflammation; Injection site pain; Myositis; Pain; Paraesthesia	FLU3~LEDERLE LABORATORIES~~UNK~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0055960	09/08/1993	WA				U	11/20/1992	1 of 3 pts who exp pain in the arm which persisted past 1 wk following vax;									U				NA	OTH	OTH	NA	NA	NA	NA~ ()~~~In patient	920384801	1						1	Pain	FLU3~LEDERLE LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0055961	09/08/1993	WA				U	11/20/1992	1 of 3 pts who exp pain in the arm which persisted past 1 wk following immunization;									U				NA	OTH	OTH	NA	NA	NA	NA~ ()~~~In patient	920384802	1						1	Pain	FLU3~LEDERLE LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0055962	09/08/1993	WA				U	11/20/1992	1 of 3 pts who exp pain in the arm which persisted past 1 wk following vax;									U					OTH	OTH	NA	NA	NA	NA~ ()~~~In patient	920384803	1						1	Pain	FLU3~LEDERLE LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0055963	09/08/1993	WA				U	11/20/1992	pt exp SOB following vax;									U				NA	OTH	OTH	NA	NA	NA	NA~ ()~~~In patient	920384804	1						1	Dyspnoea	FLU3~LEDERLE LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0055964	09/08/1993	PA	79.0	79		F	11/24/1992	w/in 12 hrs p/vax, pt exp a fever of 104; tx w/APAP; pt recovered;									Y	11/24/1992	11/24/1992	0	NA	OTH	PVT	Synthroid, Digoxin, Lasix, Valium, KCL; Bactrim;	Hypothyroidism; Uterine-carcinoma;	hypertension; CHF; Degenerative, Joint disease;	NONE~ ()~~~In patient	920384901	1						1	Pyrexia	FLU3~LEDERLE LABORATORIES~338973~1~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0055965	09/08/1993	IL	39.0			F	12/02/1992	consumer exp redness & swelling @ inject site, immed followed by tongue feeling thick & dyspnea; Adrenalin was given by paramedics; pt was brought to the hosp & released p/approx 1 hr in ER;				Y					Y	11/20/1992	11/20/1992	0	NA	PUB	PUB	NA	NONE	asthma;	NA~ ()~~~In patient	920387201	1						1	Dyspnoea; Injection site hypersensitivity; Injection site oedema; Tongue oedema	FLU3~LEDERLE LABORATORIES~338973~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0055967	09/08/1993	AZ	53.0			M	02/05/1993	reporting MD, who is pt, exp acute rt temple pain approx 16 days p/vax; dx 5th nerve inflammation; loss of sensation to the lower branch nerve; neurologist dx rt trigeminal neuropathy w/neg MRI scan approx 2 wks p/vax; pt improving;				Y					U	01/06/1993	01/21/1993	15	neuro exam inclusind cranial nerves, cerebellum, reflex, sensory, notor, gait, station & funduscopic exam nl w/exception of a dec in light touch over the 1st, 2nd, 3rd div of the trigeminal nerve on the rt; report available;	PVT	PUB	NA		pt's past medical hx has been quite benign x/for hemorrhoids in 1967 & tennis elbow in 1991; pt has seborrhea; has never had any neuro disorder; remains physically active;	NA~ ()~~~In patient	930031501	1						1	Headache; Neuritis; Neuropathy; Paraesthesia	FLU3~LEDERLE LABORATORIES~337912~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0055968	09/08/1993	PA				F	02/15/1993	consumer vaxed OCT92 & exp an allergic reaction described as a terrible itchy allergy; itching disturbs sleep @ noc; condition has lasted for 4 months & has not resolved @ time of report; 9FEB93; seen by dermatologist-tx was unsuccessful;									N	10/01/1992			NA	OTH	OTH	NA	NA	NA	NA~ ()~~~In patient	930039601	1						1	Hypersensitivity; Insomnia; Pruritus	FLU3~LEDERLE LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0056159	09/20/1993	ME	78.0	78		M	09/16/1993	8 hrs p/shot, chills & sweats body ache; temp 100/2 11SEP93 had ER visit, coughing;				Y					Y	09/07/1993	09/07/1993	0	white count 5.6;	PVT	PVT	OCtivite, Ativan	NONE	NONE	NA~ ()~~~In patient	ME93033	1						1	Chills; Cough; Hyperhidrosis; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41114~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0057496	09/20/1993	TX	4.0	4		M	09/14/1993	pt became ill w/acute lymphocytic leukemia on 23OCT93 soon p/flu vax; pt exp flu like sx & acted tired; pt had little red dots all over body; dx acute lymphoblastic leukemia;	Y		Y						N	10/10/1992	10/23/1992	13		PVT	PVT			NONE	pt exp fever, abn cells viral infect relapsed leukemia @ 4 yrs w/DTP/IPOL/PPD #1~ ()~~~In patient		1						1	Acute lymphocytic leukaemia; Asthenia; Influenza; Rash	FLU3~CONNAUGHT LABORATORIES~2731143~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0056342	09/28/1993	IN	14.0	14		M	09/21/1993	grand mal seizure 1/2-1 hrs p/vax;				Y					Y	09/20/1993	09/20/1993	0	head CT-nl;	PVT	PVT	NONE	mild rhinorrhea-no fever	cerebral palsy-autism tendencies-learning disability	NONE~ ()~~~In patient		1						1	Convulsion; Grand mal convulsion	FLU3~CONNAUGHT LABORATORIES~3F41027~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~340940~1~IM A~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0056424	10/05/1993	MN	55.0	55		F	09/30/1993	large olive sized lump @ inject site immed p/inject; ice pack immed lessened swelling; 34 hrs p/inject pt reported eyes became red, swollen, watery; eyes were matted shut;									Y	09/22/1993	09/22/1993	0	NONE	PUB	OTH	Premarin, Advil	NONE	NONE	~ ()~~~In patient		1						1	Conjunctivitis; Face oedema; Injection site mass; Injection site oedema; Lacrimal disorder	FLU3~CONNAUGHT LABORATORIES~3J41146~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056435	10/05/1993	RI	42.0	42		F	09/22/1993	Pt recvd vax 21SEP93 itching sensation started @ 10PM, 21SEP93; pt woke up @ 2AM, 22SEP93 w/hives & severe itching; seen by MD;				Y					Y	09/21/1993	09/21/1993	0	NONE	MIL	MIL	Augmenten; PPD & REcombivax by MS&D 1APR93 & 4MAR93;	ear infection (treated);	NONE	NONE~ ()~~~In patient		1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~3J41143~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0056449	10/06/1993	AL	53.0	53		F	09/30/1993	vomited in afternoon about 6 hrs p/shot, nausea since; also w/head congestion; RBS 95 day of shot; 28SEP93 on 30SEP93 347 mg/dl w/sinus tachycardia;				Y					U	09/28/1993	09/28/1993	0	EKG=R=120c decrease PVC's; RBS 347 mg/dl; T99.4; CBC nl;	PUB	PVT	Nystatin oral, Lasix, Proventin, Proventil, Azmacort, Maxair	NONE	asthma & diabetes mellitus-type II;	~ ()~~~In patient		1						1	Hyperglycaemia; Nausea; Pyrexia; Rhinitis; Tachycardia; Ventricular extrasystoles; Vomiting	FLUX~PFIZER\WYETH~4938149~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0056467	10/07/1993	CA	77.0	77		F	10/02/1993	resp/cardiac arrest;	Y	10/01/1993							N	09/30/1993	10/01/1993	1	last labs 20AUG93 Serum NA 127; serum CA+ 8.5; chlorids 88;	PVT	PVT	Sinemet; Parlodel, Xanax, Doxepin, Furosemide, ASA, Paxil	parkinsons, skin (contact derm);	sulfa/motrin advanced parkinsons disease;	~ ()~~~In patient		1						1	Apnoea; Cardiac arrest	FLUX~PFIZER\WYETH~4938137~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~340938~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Results in Death	Influenza
0056468	10/07/1993	TX	74.0	74		F	10/01/1993	petchial rash over body-referred to MD;				Y					Y	09/16/1993	09/19/1993	3	CBC-plaletlets 6;	PVT	PVT				~ ()~~~In patient		1						1	Petechiae; Thrombocytopenia	FLUX~PFIZER\WYETH~4938166~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0056472	10/07/1993	NY	65.0	65		F	10/01/1993	pt recvd vax & exp swelling, redness & itch @ site of inject;									Y	09/30/1993	09/30/1993	0	NA	PUB	PUB		NONE	HTN: renal failure;	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLUX~PFIZER\WYETH~4938158~5~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056476	10/07/1993	MD	61.0	61		F	10/06/1993	pt recvd flu vax 5OCT93; redness @ site of injection w/warmth;									Y	10/05/1993	10/06/1993	1		PUB	UNK		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLUX~PFIZER\WYETH~4938152~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056495	10/08/1993	MI	64.0	64		M	06/18/1993	day p/recvd flu shot, lt arm pain-radiating from neck to elbow & swelling occurred & lasted up to 3 months; pt also states that devel a sinus infect 1 day p/shot;									Y	11/20/1992	11/21/1992	1		MIL	MIL	Lisinopril, Sulsalate;	NONE	HTN; COPD all: PCN/Sulfa/Bee stings/Spider bites;	~ ()~~~In patient		1						1	Arthralgia; Neck pain; Oedema; Pain; Sinusitis	FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056505	10/12/1993	CA	34.0	34		F	10/04/1993	c/o itchiness over body, hard to swallow, apprehensive & nauseous, resp distress; pt devel acute resp distress w/poor air exchange required Epi & DPH repeatedly to prevent complete resp arrest;				Y					Y	10/04/1993	10/04/1993	0		MIL	MIL	PPD by Park Daivs lot# 03123P;	NONE	allergy inject;	pt exp allergy;~ ()~~~In patient	CA93085	1						1	Anxiety; Dysphagia; Dyspnoea; Nausea; Pruritus	FLU3~CONNAUGHT LABORATORIES~3J41147~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0056562	10/12/1993	OH	36.0	36		F	10/08/1993	in early AM on day following vax pt devel hives & itching; pt took DPH;				Y					U	10/07/1993	10/08/1993	1		PVT	PVT	Synthroid, Tranxene, Benadryl;	NONE	Ceftin; 90% thyroidectomy for Grave's disease;	~ ()~~~In patient		1						1	Pruritus; Urticaria	FLU3~PARKE-DAVIS~00863P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0056566	10/12/1993	CA				U	10/04/1993	20/168 devel erythematous edematous deltoid regions the size of a baseball; 60 /168 devel extremely sensitive to touch reaction x 48 hrs p/inject in the deltoid region;									Y	09/27/1993	09/27/1993	0	NA	PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056579	10/13/1993	OH	23.0	23		F	10/05/1993	devel generalized erythema, pruritus; no cardioresp; time course consistent w/immed hypersensitivity; treated w/SQ epi, po DPH;				Y					Y	09/30/1993	09/30/1993	0	skin tests to flu vax, whole egg, beef, gelatin non-reactive;	MIL	MIL	NONE	NONE	NONE	~ ()~~~In patient		1						1	Hypersensitivity; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~31J41143~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0056581	10/13/1993	IL	36.0	36		F	10/07/1993	urticaria				Y					Y	10/05/1993	10/05/1993	0		PUB	PUB	Librium, Anacid	NONE	cerebellar degeneration	~ ()~~~In patient	IL93117	1						1	Urticaria	FLU3~PARKE-DAVIS~00863P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0056582	10/13/1993	GA	72.0	72		F	10/04/1993	hives onset on 30SEP93 treated w/Seldane; hives resolved by 1OCT93;									Y	04/29/1993	09/30/1993	154	NA	OTH	PUB	Synthroid	hypothyroidism	NONE	~ ()~~~In patient		1						1	Urticaria	FLU3~LEDERLE LABORATORIES~3J41146~1~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0056584	10/13/1993	MD	39.0	39		F	10/08/1993	slight SOB x 5 mins; no treatment;									Y	10/07/1993	10/08/1993	1	NONE	PVT	PVT	Toprol XL	NONE	h/o asthma, MVP	NONE~ ()~~~In patient		1						1	Dyspnoea	FLUX~PFIZER\WYETH~4938084~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056585	10/13/1993	IN	39.0	39		F	10/06/1993	eyes swelling shut-face flushed; eyes burning-felt hot; DPH given;										10/04/1993	10/04/1993	0	NONE	PUB	PVT	NONE	NONE	cats;	~ ()~~~In patient		1						1	Eye pain; Face oedema; Pyrexia; Vasodilatation	FLUX~PFIZER\WYETH~4938160~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056602	10/15/1993	AK	51.0			M	10/05/1993	pt recvd vax & 30 mins later presented to ER c/o tachycardia, dry mouth, h/a, lightheadedness, face feeling hot; PE revealed a nl temp, BP 220/114; skin was diaphoretic; labored resp, hypertens, near syncope;					Y	1			Y	10/04/1993	10/04/1993	0	EKG revealed occasional PVC's;	PVT	OTH	Vasotec & Lanoxin, Ativan, Dapro, Glinaze;	NONE	pt is a diabetic & smokes;	~ ()~~~In patient	893279001E	1						1	Dizziness; Dyspnoea; Electrocardiogram abnormal; Headache; Hyperhidrosis; Hypertension; Tachycardia; Ventricular extrasystoles	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0056603	10/15/1993	CA	85.0	85		F	10/01/1993	Pt recvd vax & 20 mins later pt suffered a crdiac arrest & died; MD feels this event was unrelated to flu shield;	Y	09/30/1993								09/30/1993	09/30/1993	0		PVT	OTH	Maxzide unspecified;	NONE	pt was elderly & described by MD as being in frail hlth; hx of hypertension; no hx of egg allergy;	~ ()~~~In patient	893277002E	1						1	Cardiac arrest	FLUX~PFIZER\WYETH~4938120~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0056604	10/15/1993	VA	63.0	63		M	09/30/1993	pt recvd vax & devel weakness chills, & numbness of the tongue, face & arm;  Pt left the clinic, but returned c/o of additional sx of fever (to 102), flushed face, transient breathing difficulties, & swelling of the tongue; leukocytosis;				Y	Y	8			U	09/30/1993	09/30/1993	0		PVT	PVT	UNK	UNK		~ ()~~~In patient	893277001E	1						1	Abdominal pain; Asthenia; Colitis; Dyspnoea; Leukocytosis; Paraesthesia; Pyrexia; Tongue oedema	FLUX~PFIZER\WYETH~4938090~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0056605	10/15/1993	FL	43.0	43		F	10/05/1993	approx 1 hrs & 15 mins p/flu vax, pt exp sudden onset of nausea, dizziness, sweatiness; vomited a few times evening of same day & 4 times following day; sx of nausea, dizziness, sweatiness & fever (100.7);									Y	10/01/1993	10/01/1993	0	NONE	PUB	PUB	Theodur, Seldane, Axmacort, Beconase, Proventil;	NONE	chronic multiple environmental allergies & asthma;	~ ()~~~In patient	FL93058	1						1	Dizziness; Hyperhidrosis; Nausea; Pyrexia; Vomiting; Dizziness; Hyperhidrosis; Nausea; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~00973P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00973P~5~IM~LL~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0056606	10/15/1993	FL	59.0	59		M	09/27/1993	pt recvd vax on 23SEP93 & on 24SEP had chills, achiness, poss fever on sat 25SEP became SOB, diarrhea, nausea; 27SEP c/o numbness in lt leg;					Y	3				09/23/1993	09/24/1993	1		UNK	UNK			CAD, PKD, diabetes, HTN, arthritis, hx of strokes;	~ ()~~~In patient	FL93059	1						1	Chills; Diarrhoea; Dyspnoea; Myalgia; Nausea; Paraesthesia; Pyrexia	FLU3~PARKE-DAVIS~00763P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0056609	10/15/1993	MS	50.0	50		F	10/04/1993	pt recvd vax on 1OCT93 & exp soreness on 3OCT93 inc soreness in lt deltoid on 4OCt93; orange size redden raised area w/soreness noted; ice & cool cloth being applied;									Y	10/01/1993	10/02/1993	1	NONE	PUB	UNK	Estronge hormone supplement;	NONE	sinus	NONE~ ()~~~In patient	MS93038	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Myalgia	FLUX~PFIZER\WYETH~4938162~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~334957~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0056630	10/18/1993	KS	74.0	74		M	09/30/1993	23SEP93 severe itching under arms; 24SEp93 rash all over body lasted 1 day;									Y	09/22/1993	09/23/1993	1		PUB	UNK		NONE	NONE	~ ()~~~In patient	KS93051	1						1	Pruritus; Rash	FLU3~PARKE-DAVIS~01173P~2~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0056632	10/18/1993	MS	43.0	43		F	10/06/1993	pt noticed itching @ inject site p/getting flu vac 1OCT93; rash on trunk, extremities approx 2 hrs p/vax; inject site sore, red & feverish; pt took DPH 5OCt92 to 6OCT92; rash going away today 6OCT93; pt did not see MD;									Y	10/01/1993	10/01/1993	0		PUB	PUB				~ ()~~~In patient	MS93039	1						1	Injection site hypersensitivity; Injection site pain; Pruritus; Rash; Vasodilatation	FLUX~PFIZER\WYETH~4938162~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056633	10/18/1993	MS	75.0	75		F	10/08/1993	pt states took flu shot on Wednesday 6OCT93; broke out w/hives noted 7OCT93 AM on awakening; hives on abod, inner aspect of both arms, groin thighs & back; c/o itching to groin area on 8OCT93; call MD 8OCT93;									Y	10/06/1993	10/07/1993	1		PUB	PUB	Pristecs, Pamelor, Buspar, Synthroid, Premarin, Voltarea;	flu feeling w/o temp for yrs NKA	CAT Scan 29SEP abod area, pelvis area w/dye; 22SEP heart scan w/dye in slidel in LA MD;	~ ()~~~In patient	MS93040	1						1	Pruritus; Urticaria	FLUX~PFIZER\WYETH~4938162~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056634	10/18/1993	MS	77.0	77		M	10/13/1993	pt recvd vax 1030AM on 11OCT93 fever started 4Pm all that noc no fever 12OCT; redness & swelling above elbow noticed 12OCT @ 5 PM; warm to touch;									Y	10/11/1993	10/11/1993	0	t97.6 orally 13OCT93;	PUB	PUB	Ectrin, Tagmet, Metroclopramide, Procardix XL;		heart problem;	~ ()~~~In patient	MS93041	1						1	Injection site hypersensitivity; Injection site oedema; Pyrexia; Vasodilatation	FLUX~PFIZER\WYETH~4938158~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~334957~2~IM~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0056636	10/18/1993	VA	66.0	66		M	10/13/1993	wife relates pt began sweating, got dizzy & blacked out; went by ambulance to ER; then also had SOB, skin rash, low blood pressure; held for 6-7 hrs; sent home w/rx's of DPH & Pred;				Y					Y	10/11/1993	10/12/1993	1	Not known;	PUB	PUB	Quinidine, Lanoxin	arrythmia	arrythmia	NA~ ()~~~In patient	VA93080	1						1	Dizziness; Dyspnoea; Hyperhidrosis; Hypotension; Rash; Syncope	FLU3~CONNAUGHT LABORATORIES~3F41035~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0056637	10/18/1993	WV	53.0	52		F	10/08/1993	S&S swelling in throat, rash from top of head to the waist (like hives), rash burns-nausea;				Y					Y	10/06/1993	10/07/1993	1	severe react to flu vax;	PUB	PUB	Humlin-N	NONE	heart attack-inc BP-diabetes-Thyroid;	~ ()~~~In patient	WV9332	1						1	Laryngospasm; Nausea; Pain; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~3F41008~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0056647	10/18/1993	PA	81.0	81		M	10/04/1993	pt recvd flu shot 4OCT93 c/o fever, achiness, productive cough late that noc; seen 11OCT93 rales; URI;				Y						10/04/1993	10/04/1993	0	CXR:	PVT	UNK	TCN for acne;	NONE	NONE	pt states got flu p/flu shot one other yr;~ ()~~~In patient		1						1	Cough; Lung disorder; Myalgia; Pharyngitis; Pyrexia	FLU3~PFIZER\WYETH~361923~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0056649	10/18/1993	MN	41.0	41		F	10/12/1993	approx 4 hrs p/inject, eyelids became swollen, eyes were burning, itching, became bloodshot drainage;				Y					Y	10/07/1993	10/07/1993	0		PVT	UNK	Premarin	NONE	NONE	~ ()~~~In patient		1						1	Conjunctivitis; Eye pain; Face oedema; Pruritus	FLU3~PARKE-DAVIS~00193P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0056650	10/18/1993	MN	40.0	40		F	10/08/1993	4-5 hrs p/receiving vax, eyes became very red, drainage in eyes, eyelids swelled, t101, chills, lungs felt congested, was SOB;				Y					Y	10/07/1993	10/07/1993	0		PVT	UNK		NONE	NONE	~ ()~~~In patient		1						1	Chills; Conjunctivitis; Dyspnoea; Face oedema; Lung disorder; Pyrexia	FLU3~PARKE-DAVIS~000193P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0056653	10/18/1993	FL	54.0	54		F	10/12/1993	pt recvd vax 11OCT93 & had h/a; 12OCT93 had chills, fever, h/a, nausea; 13OCT93 AM only had mild h/a;									U	10/11/1993	10/12/1993	1		PUB	PVT	Lotensin	NONE	NONE	~ ()~~~In patient		1						1	Chills; Headache; Nausea; Pyrexia	FLUX~PFIZER\WYETH~4938143~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056654	10/18/1993	TX	7.0	7		M	10/08/1993	broke out in hives/welts;									Y	10/06/1993	10/06/1993	0	NONE	PVT	UNK		NONE	NONE	~ ()~~~In patient		1						1	Urticaria	FLUX~PFIZER\WYETH~4938153~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056656	10/18/1993	CA				F	10/12/1993	pruritic eruption beginning 1-2 days post inject; some lip swelling; much induration @ inject site; needed DPH, Seldane;									Y	09/28/1993	10/01/1993	3	NONE	PVT	PVT	Methatrexate, Imuran, TOradol, Darvocet, Amoxicillian;	chronic psorcatic arthritis;		~ ()~~~In patient		1						1	Face oedema; Injection site mass; Pruritus; Rash	FLUX~PFIZER\WYETH~4938122~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056660	10/18/1993	WI	10.0	10		F	10/11/1993	3 x 3 induration lt deltoid reported by mom;									Y	10/06/1993	10/06/1993	0	NONE	PVT	UNK		NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site mass	FLUX~PFIZER\WYETH~4938086~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056661	10/18/1993	IN	30.0	30		F	10/13/1993	4 days p/inject devel fever, chills, muscle soreness; hive like rash-bilat arms, forehead, thigh; persistent, migratory myalgia; dx serum sickness;									Y	10/01/1993	10/05/1993	4		PVT	PVT		NONE		~ ()~~~In patient		1						1	Chills; Myalgia; Pyrexia; Serum sickness; Urticaria	FLU3~PARKE-DAVIS~00863P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0056674	10/19/1993	MO	41.0	41		F	10/13/1993	ears red, warm face flushed pt described shaky feeling given DPH;				Y					Y	10/12/1993	10/12/1993	0		OTH	OTH	Bronchodilator recent ATB;		allergic to Cephalexin, TCN, Erythromycin;	~ ()~~~In patient		1						1	Tremor; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3J41146~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0056677	10/19/1993	MO	28.0	28		F	10/13/1993	fever, nausea, vomiting, weakness onset; approx 6 hrs p/inject; duration 48 hrs; no treatment;									Y	10/08/1993	10/08/1993	0		OTH	OTH		NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Nausea; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~3J41146~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056681	10/20/1993	LA	59.0	59		M		sore throat, low grade temp, tightness in chest 2 days p/recvd vax; 3rd day lt eye swelled shut;									Y	09/30/1993	10/02/1993	2	NONE	OTH	UNK			allergic to platinum	NONE~ ()~~~In patient		1						1	Chest pain; Face oedema; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41141~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056682	10/20/1993	LA	62.0	62		M	10/15/1993	2 days p/shot a rash devel & rt side of head hurt around jaw bone;									Y	09/23/1993	09/25/1993	2	NONE	OTH	OTH		NONE	allergy to platinum	~ ()~~~In patient		1						1	Headache; Rash	FLU3~CONNAUGHT LABORATORIES~3F41141~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056683	10/20/1993	OH	38.0	38		F	10/14/1993	pt recvd vax 11OCT93 on 13OCT93 11PM devel generalized itching w/rash, face, chest, arms;										10/11/1993	10/13/1993	2		PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Pruritus; Rash	FLUX~PFIZER\WYETH~4938141~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056687	10/21/1993	AL	24.0	24		F	10/06/1993	630AM 6OCT93 c/o nausea, felt chilled 7AM - 730-8AM felt hot flash & got light headed & weak; presented to clinic 930 c/o headache malaise;				Y						10/05/1993	10/06/1993	1		PUB	UNK	NONE	NONE	allergic inhalants-milk products-cod fish;	pt exp flu sx @ 21 w/flu vax;~ ()~~~In patient	AL93042	1						1	Asthenia; Chills; Dizziness; Headache; Malaise; Nausea; Vasodilatation	FLUX~PFIZER\WYETH~4938182~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0056690	10/21/1993	MN	54.0	54		F	10/07/1993	next day p/the flu shot had dizziness, h/a, pain all over & no appetitie;									Y	10/01/1993	10/02/1993	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MN93051	1						1	Anorexia; Dizziness; Headache; Pain	FLUX~PFIZER\WYETH~4938141~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056699	10/21/1993	FL	66.0	66		F	10/15/1993	nausea, weakness, dizziness, fever, aches, soreness;									U	10/13/1993	10/14/1993	1		PVT	PVT				~ ()~~~In patient		1						1	Asthenia; Dizziness; Myalgia; Nausea; Pyrexia	FLUX~PFIZER\WYETH~4938143~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056702	10/21/1993	OR	18.0	18		F	10/13/1993	fever, aches, red swollen lt arm-approx 6cm area, h/a;									Y	10/11/1993	10/11/1993	0	NONE	OTH	PUB	NONE			~ ()~~~In patient		1						1	Headache; Injection site hypersensitivity; Injection site oedema; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~4938193~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056704	10/21/1993	IN	69.0	69		F	10/18/1993	chills, fever, myalgias, neuritis;									U	10/07/1993	10/07/1993	0		PVT	PVT	Minipress, Dyazide, isorniazid;	recovering upper resp infect;	afebrile pos mantoux-prophylaxis INH	~ ()~~~In patient		1						1	Chills; Myalgia; Neuritis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41132~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056706	10/22/1993	ME	56.0	56		F	10/13/1993	pt said has a severe chest cold, bad sore throat, runny nose;									N	10/05/1993	10/08/1993	3		PVT	PVT	NONE	NONE	allergic to PCN;	NONE~ ()~~~In patient	ME93037	1						1	Pharyngitis; Rhinitis	FLU3~PARKE-DAVIS~01273P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0056707	10/22/1993	ME	32.0	32		F	10/15/1993	8OCT stomach ache-stomach cramps; 10OCT 4PM cold, chills, shaking, t102, went to ER: 11OCT 9Am diarrhea, vomiting, heart palpitations, went to ER:				Y					Y	10/07/1993	10/08/1993	1	urinalysis, blood count, EKS, CXR-all nl;	PVT	PVT	LEvathroid, Premrine;	NONE	hyperthyroidism, endometriosis;	NONE~ ()~~~In patient	ME93038	1						1	Abdominal pain; Chills; Diarrhoea; Palpitations; Pyrexia; Tremor; Vomiting	FLUX~PFIZER\WYETH~4938124~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0056708	10/22/1993	ME	48.0	48		F	10/14/1993	The pt said devel a sunburn-like rash on face & that noc was wheezing; the next day both of hands were numb; later felt tingly;									Y	10/04/1993	10/08/1993	4	NONE	PUB	PUB	NONE	NONE	allergic to codeine	NONE~ ()~~~In patient	ME93039	1						1	Asthma; Paraesthesia; Rash	FLUX~PFIZER\WYETH~4938119~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056710	10/22/1993	MO	80.0	80		M	10/12/1993	extremely dizzy & nauseated; became dizzy Friday AM; nausea started Saturday afternoon; Today 12OCT93  feels much better;									Y	10/07/1993	10/08/1993	1	NONE	PUB	OTH	Feldene	NONE	NKA	~ ()~~~In patient	MO93094	1						1	Dizziness; Nausea	FLU3~CONNAUGHT LABORATORIES~3F41033~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056711	10/22/1993	MO	16.0	16		F	10/14/1993	12OCT93 pt devel swelling of lower lips; no diff breathing or swallowing; no hives or urticaria; advised DPH & ice compresses; 13OCT93 lips inc swelling w/some improvement w/ice & DPH; advised to observe;									Y	10/12/1993	10/12/1993	0	NONE	PVT	PVT	NONE	NONE	asthma, allergic rhinitis	~ ()~~~In patient	MO93095	1						1	Face oedema	FLU3~PFIZER\WYETH~361927~UNK~~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0056713	10/22/1993	FL	51.0			M		pt admitted w/anaphylatic react to flu shot; started on NTG paste p/ c/o chest pain-h/a;					Y					09/29/1993	09/29/1993	0		UNK	UNK	Nitropaste;			~ ()~~~In patient		1						1	Anaphylactoid reaction; Chest pain; Headache	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0056716	10/22/1993	MD	53.0	53		F	10/15/1993	pt was given a flu vax on 13OCt93 & returned to the clinic 15OCT93 & had a small area of redness @ the inject site; pt states arm hurts;									Y	10/13/1993	10/13/1993	0		OTH	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pain	FLU3~CONNAUGHT LABORATORIES~3J41146~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056717	10/22/1993	VA	48.0	48		M	10/18/1993	became ill on 9OCT, fever 100.7, upper resp infect, stuffy/runny nose, sinus pains, cough;									U	10/06/1993	10/09/1993	3	NONE	PUB	PUB		NA	sinusitis			1						1	Cough; Pain; Pharyngitis; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~3J41146~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056718	10/22/1993	VA	49.0	49		F	10/15/1993	mild nausea, malaise; irritation & swelling 2 1/2 x 2 around inject site;									Y	10/08/1993	10/10/1993	2	NA	PUB	PUB	Phenobarbital, Doxepin, Zoloft, Lithium, Premarin;	NONE	Vancomycin	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Malaise; Nausea	FLU3~CONNAUGHT LABORATORIES~3J41146~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056719	10/22/1993	VA	35.0	35		F	10/19/1993	13OCT93 recvd flu inject & 14OCT(3 6PM itching/redness on lt arm; 15OCT93 wheal noticed 2 from inject & swelling of lt arm; t101 430AM nausea & dry cough;										10/13/1993	10/14/1993	1	NONE	PUB	PUB	Birth control pills, Inderal	NONE	allergy to PCN,  macrodantin, Keflex, Pork;	NONE~ ()~~~In patient		1						1	Cough; Injection site hypersensitivity; Nausea; Oedema peripheral; Pruritus; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3J41146~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056720	10/25/1993	TN	56.0	56		M	09/20/1993	Pt recvd 16SEP93 15 hrs later, pt presented to ER w/fever of 100.6, hypertensive 140/100 & lt arm pain that traveled from inject site to lt shoulder; pt hospitalized;					Y	13			N	09/16/1993	09/17/1993	1	CBC: WBC 14,000 (82S, 15L, 3 mono) on admission 17SEP93; WBC 23,000 (83S, 14Mono) on 18SEP93; CXR neg; 2 blood cultures w/o strep pneumonia;	PVT	PVT	Coumadin, Cardizem;	NONE	diabetes, CHF, chronic atrial fibrillation, overweight;	none~ ()~~~In patient	930204801	1						1	Hypertension; Infection; Injection site pain; Leukocytosis; Pain; Pyrexia; Sepsis	FLU3~PFIZER\WYETH~3F41124~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|PPV~PFIZER\WYETH~344950~UNK~~~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0056721	10/25/1993	CA	70.0	70		F	10/12/1993	pt recvd flu vax 9OCT93 approx 24 hrs later pt devel fever & nausea; died in the ambulance on the way to the hosp;	Y	10/10/1993							N	10/09/1993	10/10/1993	1		PUB	OTH	Dicloxacillin; APAP w/codeine, Prilosec, Mevacor, Tenormin, Zestril, Colchicine, Tagamet, Indocin, HCTZ, Reglan;		Hypertension, diverticulitits, hiatal hernia, severe coronary artherosclerosis, nephrosclerosis, pituitary adenoma, obesity;	~ ()~~~In patient	893285016J	1						1	Deep vein thrombosis; Nausea; Pulmonary embolism; Pyrexia; Syncope	FLUX~PFIZER\WYETH~4938180~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0056722	10/25/1993		22.0			F	10/11/1993	accidental overdose, inject site soreness & tiredness; pt was not receiving any other meds; pt recvd flu vax 10OCT93 recvd 5ml instead of 0.5ml;									U	10/10/1993	10/11/1993	1		OTH	OTH	NONE	NS	NS	NS~ ()~~~In patient	PD26885	1						1	Asthenia; Injection site pain; Overdose	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0056737	10/25/1993	ME	50.0	50		F	10/18/1993	arm was stiff x 3 days, stomach upset 13OCT93 sick to stomach, h/a; 14OCT93 loose stools, vomiting;									Y	10/04/1993	10/05/1993	1	NONE	OTH	PUB	Synthroid	NONE	sinus condition	NA~ ()~~~In patient	ME93040	1						1	Diarrhoea; Dyspepsia; Headache; Hypertonia; Vomiting	FLU3~CONNAUGHT LABORATORIES~3F41123~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056738	10/25/1993	NC	23.0	23		F	10/13/1993	pt had flu shot 910AM went to another agency & got pneumonia shot @ 1110AM; sx started about 310PM the same day h/a, nausea, fever, chills & sore arm @ inject site; pt is to see MD today;				Y					Y	10/12/1993	10/12/1993	0		PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient	NC9384	1						1	Chills; Headache; Injection site pain; Nausea; Pyrexia	FLU3~PARKE-DAVIS~000973P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~UNKNOWN MANUFACTURER~~1~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0056739	10/25/1993	NC	67.0	67		F	10/14/1993	pt had hives, chills, heaviness in chest & swollen lips; states was itching bad; laid down & took nap x 1 1/2 hrs; felt much better upon rising all sx were gone x/bumps on arm; advised to see MD;									Y	10/12/1993	10/12/1993	0		PUB	PVT				~ ()~~~In patient	NC9385	1						1	Chest pain; Chills; Face oedema; Pruritus; Skin nodule; Urticaria	FLU3~PARKE-DAVIS~00973P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0056740	10/25/1993	NC	46.0	46		M	10/14/1993	pt states arm swollen, red & had raised bumps x 2 days; states today the area looks like a cigarette burn; states it itched alittle @ first but doesn't now; white w/small amount of pus;									Y	10/12/1993	10/12/1993	0		PVT	PVT				~ ()~~~In patient	NC9386	1						1	Infection; Oedema peripheral; Pruritus; Skin discolouration; Skin nodule; Vasodilatation	FLU3~PARKE-DAVIS~01263P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0056744	10/25/1993	TN	74.0	74		F	10/12/1993	itchy on arm where shot was recvd x 1 day; sore arm-red presently; malaise x 1 day; pain in neck & arm;									Y	10/07/1993	10/07/1993	0	NA	PUB	PUB	Vasotec, Premarin;	asthmatic bronchitis;	certain flowers (head congestion) chocolate, berries, shellfish, steroids;	~ ()~~~In patient	TN93093	1						1	Malaise; Myalgia; Neck pain; Pain; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~4938084~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056745	10/25/1993	TN	35.0	35		F	10/14/1993	sl h/a, stopped up, tired, throat scratchy;									N	10/13/1993	10/14/1993	1	NA	PUB	PUB	Sterpid-Predforte, Timoptic;	NONE	pt states has upper resp problems;	~ ()~~~In patient	TN93094	1						1	Asthenia; Condition aggravated; Headache; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~3F41033~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056746	10/25/1993	TN	32.0	32		F	10/18/1993	swollen arm @ inject site, area warm itching all over; h/a;									Y	10/15/1993	10/16/1993	1		PUB	PUB				~ ()~~~In patient	TN93095	1						1	Headache; Injection site oedema; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~4398181~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056761	10/25/1993	FL	39.0	39		F	10/21/1993	SOB; seeing spots a/eyes lt arm sore & numb;				Y					Y	10/20/1993	10/20/1993	0		OTH	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Dyspnoea; Myalgia; Paraesthesia; Visual disturbance	FLU3~PARKE-DAVIS~00193~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0056764	10/25/1993	FL	35.0	35		F	10/18/1993	pt recvd vax 7OCT93 to lt deltoid place of employment; lt UE numbness 8OCT93 (no weakness); exam-nl- c-spine; nl grip strength & deltoid strength; dec in pin prick sensation lt radial dorsal hand;				Y					Y	10/07/1993	10/08/1993	1	not indicated;	OTH	PVT	Provera;	NONE	NONE	~ ()~~~In patient		1						1	Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0056770	10/25/1993	NH	77.0	77		F	10/18/1993	25SEP wheezing & coughing; prescription w/Pred x 5 days Robitussin;									Y	09/23/1993	09/25/1993	2	NA	PVT	PVT		NONE	diabetic, hypertension, some SOb, hx bronchitis;	~ ()~~~In patient	NH93017	1						1	Asthma; Cough	FLU3~CONNAUGHT LABORATORIES~3F41016~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056771	10/25/1993	MI	51.0	50		F	10/18/1993	5 mins post vax reported lightheadedness 15 mins noted rash on neck; c/o of general itchy; w/in 30 mins itching became severe; devel raised rash on back, abd, rt upper arm rash; rt upper arm near inject site;									Y	10/18/1993	10/18/1993	0		OTH	UNK	Premarin & provera;	NONE	NONE	~ ()~~~In patient		1						1	Dizziness; Injection site hypersensitivity; Pruritus; Rash	FLU3~PARKE-DAVIS~00783P~4~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0056773	10/25/1993	TX	57.0	57		F	10/19/1993	pt recvd vax 730AM; 8OCT93 1st sx faint rash (like Roseola) in Am 9OCT93 all over body; rash resolved in about 4 days; 11OCT93 began to exp swollen, achy joints; resolving about 1 wk;									Y	10/08/1993	10/09/1993	1	NONE	UNK	PVT	Premarin, Bumex, Calan, K-TAB, Amitriptyline, Vitas, Excedrin;	NONE	hypertension, PAT, mitral valve prolapse;	~ ()~~~In patient		1						1	Arthralgia; Osteoarthritis; Rash	FLUX~PFIZER\WYETH~4938144~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056774	10/25/1993	NM	46.0	46		F	10/19/1993	awake middle of noc w/itching in face, neck behind ears upper chest; has lot of periorbital edema; NO SOB;									Y	10/18/1993	10/18/1993	0		UNK	UNK				~ ()~~~In patient		1						1	Face oedema; Insomnia; Pruritus	FLU3~CONNAUGHT LABORATORIES~3F41125~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056775	10/25/1993	NY	52.0	52		F	10/19/1993	rash, itch, hands swollen 2 days p/inject;									Y	10/04/1993	10/06/1993	2		PUB	UNK	Thyroid	NONE	Thyroid (nodules);	~ ()~~~In patient		1						1	Oedema peripheral; Pruritus; Rash	FLUX~PFIZER\WYETH~4938151~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056776	10/25/1993	HI	79.0	78		F	10/15/1993	redness & warmth sensation @ 3x3 @ site;									Y	10/06/1993	10/07/1993	1	NONE	OTH	OTH	mild inc TSH anemia hyperbilrunemia;		s/p cabg	~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLUX~PFIZER\WYETH~4938137~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056777	10/25/1993	MI	47.0	46		F	10/19/1993	swelling, redness, least & tenderness of rt arm from shoulder to elbow;										10/18/1993	10/18/1993	0		PVT	PVT	Desipramine; Premarin; Provera	NONE	allergies: Bactrim, dust, mold;	~ ()~~~In patient		1						1	Oedema peripheral; Pain; Vasodilatation	FLUX~PFIZER\WYETH~4938147~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056778	10/25/1993	OK	22.0	22		F	10/18/1993	arms swelled, had fever, very sore formed knot size of baseball;									Y	09/21/1993	09/21/1993	0		PUB	PVT		NONE		~ ()~~~In patient		1						1	Myalgia; Oedema peripheral; Pyrexia; Skin nodule	FLU3~CONNAUGHT LABORATORIES~3F41027~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056780	10/25/1993	SD	72.0	72		F	10/14/1993	14OCT awake itching & broken red heat rash;									U	10/12/1993	10/14/1993	2		OTH	PUB	Insomethocin; APAP	NONE	NKA, arthritis (degenaratheise);	NA~ ()~~~In patient		1						1	Pruritus; Rash	FLUX~PFIZER\WYETH~4938145~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056781	10/25/1993	AK	29.0	29		F	10/18/1993	lt proximal arm w/4x6 violaceous, sl raised, sl indurated, tender area; treated w/DPH;									Y	10/13/1993	10/14/1993	1	NA	MIL	MIL	BCP, CTM;	NONE	PCN allergy;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~CONNAUGHT LABORATORIES~3J41143~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056782	10/25/1993	CO	30.0	30		F	10/19/1993	on 7OCT93 pt noted large red swollen lump @ inject site; approx 2 1/2 diameter on 8OCT93; size had dec-site not painful or interfering w/work or adls;									Y	10/06/1993	10/07/1993	1	NONE	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~3F41172~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056783	10/25/1993	CO	35.0	34		F	10/19/1993	17OCT93 pt noted a 1 1/2 diameter lump @ inject site; 18OCT it was up to 3 & red on 19OCT93 site was red non tender;									Y	10/16/1993	10/17/1993	1	NONE	OTH	PVT	NONE			~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~3F41032~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056785	10/25/1993	TN	34.0	34		M	10/07/1993	pt recvd vax & now has a silver dollar sized hard warm bruised area to lt deltoid area;										10/06/1993	10/07/1993	1	NA	MIL	MIL	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Ecchymosis; Injection site mass; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3J41143~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056788	10/26/1993	TN	29.0	29		M	10/22/1993	swelling of fingers 2nd hand (no pain) 3 days p/shot; bottom of feet itching; some swellings;										10/20/1993	10/22/1993	2	NA	PUB	PUB	NA	NA	PCN allergy	~ ()~~~In patient	TN93097	1						1	Oedema peripheral; Pruritus	FLU3~CONNAUGHT LABORATORIES~3F41033~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056789	10/26/1993	TN	49.0	49		F		upper resp congestion-same day; sl earache;										10/20/1993	10/29/1993	9	NA	PUB	PUB	NA	NA	NA	~ ()~~~In patient	TN93098	1						1	Ear pain; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~3F41033~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056790	10/26/1993	OK	58.0	58		F	10/21/1993	Pancreatitis 2 days p/flu vax;			Y						Y	09/30/1993	10/15/1993	15	pt had exploration lap;	PUB	UNK	MANY		cardiomyopathy/atrialarr	~ ()~~~In patient		1						1	Pancreatitis	FLUX~PFIZER\WYETH~4938226~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0046746	10/27/1993	PA	27.0	27		F	08/03/1993	immediate local erythematous wheal 1;									Y	10/31/1991	10/31/1991	0		UNK	UNK	Cisapride;		past history of neuropathic intestinal pseudo obstruction;	~ ()~~~In patient	CO4576	1						2	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~1F21219~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0056605	10/27/1993	FL	43.0	43		F	10/05/1993	approx 1 hrs & 15 mins p/vax pt exp sudden onset of nausea, dizziness, sweatiness; vomited a few times evening of same day, & 4 times following day; sx of nausea, dizziness, sweatiness & fever (100.7);									Y	10/01/1993	10/01/1993	0	NONE	PUB	PUB	Theodur, Seldane, Azmacott, Beconase, Proventil;	NONE	chronic multiple environmental allergies & asthma;	~ ()~~~In patient	FL93066	1						2	Dizziness; Hyperhidrosis; Nausea; Pyrexia; Vomiting; Dizziness; Hyperhidrosis; Nausea; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~00973P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00973P~5~IM~LL~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0056793	10/27/1993	FL	67.0	67		F	10/19/1993	t100, chills, nausea x 5 days;									Y	10/01/1993	10/02/1993	1		PUB	PUB	Estrogen replacement;	NONE	NONE	~ ()~~~In patient	FL93063	1						1	Chills; Nausea; Pyrexia	FLU3~PARKE-DAVIS~00573P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0056798	10/27/1993	ME	68.0	68		F	10/19/1993	15OCT93 stiffness in joints of legs-elbows; 16OCT sore throat; 17OCT sore throat worsened, swollen glands; 18OCT still not feeling better; 19OCT still no feeling beter;									N	10/07/1993	10/15/1993	8	NONE	PVT	PVT	NONE	NONE	several allergies;	NONE~ ()~~~In patient	ME93091	1						1	Arthropathy; Lymphadenopathy; Pharyngitis	FLUX~PFIZER\WYETH~4938119~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056805	10/27/1993	NY	92.0			F		pt recvd vax & 5 mins later found unconscious, diaphoretic, hypotens in exam room; responded to saline IV, hosp admission;					Y					10/19/1993	10/19/1993	0	nl lab;	UNK	UNK	Pairnviv, Procanin, Lasix;		hypotens, anemia, osteoporosis, breast CA;	~ ()~~~In patient		1						1	Hyperhidrosis; Hypotension; Syncope	FLU3~CONNAUGHT LABORATORIES~3F41122~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0056810	10/27/1993	MD	50.0	50		F	10/22/1993	immed lump arose @ site; treatment: ice pack to site, DPH given pt observed for 30 mins; advised to call PMD;									Y	10/20/1993	10/20/1993	0	NONE	PUB	PUB	NONE	NONE	bee sting, codeine, steroids;	~ ()~~~In patient		1						1	Injection site mass	FLU3~CONNAUGHT LABORATORIES~3J41146~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056812	10/27/1993	MN	47.0	47		F	10/20/1993	pt devel fever, muscle aching, significant nasal congestion;									Y	10/07/1993	10/07/1993	0		PVT	PVT	Insulin, THyroid, Vasotec, Magnesium, Vit E, C, Motrin, Macyte;	NONE	sulfa, Idoine, Tuberculin, PPN, Diabetes, TBP, heart disease;	pt had allerg react to PPD;~ ()~~~In patient		1						1	Myalgia; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~4938142~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056813	10/27/1993	MN	45.0	45		F	10/20/1993	pt exp vomiting & diarrhea x 12 hrs, fatigue-stomach & tenderness x 48 hrs;									Y	10/15/1993	10/16/1993	1		PVT	PVT	unk	NONE	NONE	UNK~ ()~~~In patient		1						1	Abdominal pain; Asthenia; Diarrhoea; Vomiting	FLUX~PFIZER\WYETH~4938142~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056814	10/27/1993	MN				F	10/20/1993	12 hrs p/inject devel fever, generalized muscle aching, fatigue; required bed rest & analgesics; sx subsided in 24 hrs;									Y					PVT	UNK	UNK	NONE	NONE	NONE~ ()~~~In patient		1						1	Asthenia; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~4938142~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056818	10/27/1993	OK	41.0	40		F	10/19/1993	inject site became red, swollen & itchy;									Y	09/22/1993	09/22/1993	0	NONE	PVT	PVT	Ogen	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~CONNAUGHT LABORATORIES~3F41027~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057039	10/27/1993	MA				F	08/03/1993	pt exp rasied rash on chest, neck & waistline area for 3-4 wks; no itch assoc w/rash;									Y	10/05/1992	10/05/1992	0		UNK	UNK				~ ()~~~In patient	CO4574	1						1	Rash	FLU3~PARKE-DAVIS~~UNK~SC~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057040	10/27/1993	MN				M	08/03/1993	10cm area of inflammation & induration;									Y					UNK	UNK				~ ()~~~In patient	CO4575	1						1	Injection site inflammation; Injection site mass	FLU3~PARKE-DAVIS~~UNK~SC A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057042	10/27/1993	TX	29.0	29		F	08/03/1993	Redness @ site, swelled & then arm swelled signigicant to fingers; lasted aprpox 1 1/2 days; arm was splotched w/red all over;									Y	09/29/1992	09/29/1992	0		UNK	UNK			allergic to everything? x/eggs;	pt exp swelling @ age 25 w/Tetanus inject;~ ()~~~In patient	CO4587	1						1	Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Rash maculo-papular	FLU3~PARKE-DAVIS~2F31143~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057043	10/27/1993	TX	41.0	41		F	08/03/1993	flu like sx occurred on 30SEP w/fever, devel into cold; lasted through following wk;									Y	09/29/1992	09/30/1992	1		UNK	UNK				~ ()~~~In patient	CO4588	1						1	Influenza; Pharyngitis; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~2F31143~2~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057044	10/27/1993	TX	32.0	32		F	08/03/1993	hot & swollen for a couple of days; stayed red & itched;									Y	09/29/1992	09/29/1992	0		UNK	UNK				~ ()~~~In patient	CO4589	1						1	Oedema; Pruritus; Vasodilatation	FLU3~PARKE-DAVIS~2F31143~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057045	10/27/1993	TX	33.0	33		F	08/03/1993	heat @ site lasting 2 days;									Y	09/20/1992	09/30/1992	10		UNK	UNK				~ ()~~~In patient	CO4590	1						1	Vasodilatation	FLU3~PARKE-DAVIS~2F31143~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057046	10/27/1993	TX	29.0	29		M	08/03/1993	site ached, swollen & redness; lasted 2-3 days; no prior vax;									Y	09/29/1992	09/30/1992	1		UNK	UNK				~ ()~~~In patient	CO4591	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~2F31143~1~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057047	10/27/1993	TX	27.0	27		F	08/03/1993	Swollen & red @ site; no prior vax;									Y	09/29/1992	09/30/1992	1		UNK	UNK			nl allergies & asthma;	~ ()~~~In patient	CO4592	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PARKE-DAVIS~2F31143~1~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057048	10/27/1993	TX	24.0	24		F	08/03/1993	Swelling, redness & heat; lasted about 2 days; no prior vax;									Y	09/29/1992	09/29/1992	0		UNK	UNK				~ ()~~~In patient	CO4593	1						1	Oedema; Vasodilatation	FLU3~PARKE-DAVIS~2F31143~1~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057049	10/27/1993	TX	33.0	33		F	08/03/1993	Felt cold, run down; like flu onset; occurred about noon; By 4PM felt better; site turned red, 3 diameter, stayed red for a wk & was sore; no prior vax;									Y	09/29/1992	09/29/1992	0		UNK	UNK				~ ()~~~In patient	CO4594	1						1	Asthenia; Chills; Influenza; Injection site hypersensitivity; Injection site pain	FLU3~PARKE-DAVIS~2F31143~1~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057050	10/27/1993	TX	44.0	44		F	08/03/1993	localized soreness, redness & heat & swelling for 2 days; dizziness, nausea, flushing on the 1st day; No prior vax;										09/29/1992	09/29/1992	0		UNK	UNK			allergic or sensitive to citric acid;	~ ()~~~In patient	CO4595	1						1	Dizziness; Injection site hypersensitivity; Injection site oedema; Injection site pain; Nausea; Vasodilatation	FLU3~PARKE-DAVIS~2F31143~1~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057051	10/27/1993	TX	49.0	49		F	08/03/1993	Localized swelling, heat & redness; lasted approx 1 wk; No prior vax;									Y	09/29/1992	09/30/1992	1		UNK	UNK				pt exp pain & swelling p/Tetanus inject @ 35 y/o;~ ()~~~In patient	CO4596	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PARKE-DAVIS~2F31143~1~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057052	10/27/1993	TX	44.0	44		F	08/03/1993	Site itched, hot, red, & swollen; lasted 4 days; no prior vax;									Y	09/29/1992	09/29/1992	0		UNK	UNK			allergy to dander, dust mites, tree shrubs & grass;	~ ()~~~In patient	CO4597	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLU3~PARKE-DAVIS~2F31143~1~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057053	10/27/1993	TX	50.0	50		F	08/03/1993	Dizziness to feeling of fainting @ firs which lasted about 15 mins; No swelling @ site, but warm; No prior vax;									Y	09/29/1992	09/29/1992	0		UNK	UNK				~ ()~~~In patient	CO4598	1						1	Dizziness; Vasodilatation	FLU3~PARKE-DAVIS~2F31143~1~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057054	10/27/1993	NJ	52.0			F	08/03/1993	Intense local redness & swelling; persistent pain p/3-4 wks; On long term Coumadin therapy but does not have a hemantoma @ the site;									N					UNK	UNK				~ ()~~~In patient	CO4600	1						1	Injection site hypersensitivity; Injection site oedema; Pain	FLU3~PARKE-DAVIS~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057055	10/27/1993	MO	75.0	75		F	08/03/1993	Arm red, swollen, warm to touch, pain elbow to shoulder; had vax in the past; 1FEB93 no addtl event information recvd;									Y	12/21/1992	12/22/1992	1		UNK	UNK				~ ()~~~In patient	CO4624	1						1	Oedema peripheral; Pain; Vasodilatation	FLU3~PARKE-DAVIS~2F31003~2~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057056	10/27/1993	NY	16.0			F	08/03/1993	h/a & myalgia p/inject; 30MAR93 no addtl event info recvd; not the vax provider;									U		11/06/1992			OTH	PVT	Symmetic 1;	influenza	bronchial asthma;	pt exp cephalgia, myalgia & fatigue;~ ()~~~In patient	CO4686	1						1	Headache; Myalgia	FLU3~PARKE-DAVIS~2F31156~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057057	10/27/1993	NJ	55.0	55		F	08/03/1993	full blown flu infect w/fever, malaise, fatigue & cough; No culture done; husband also got flu; 30APR93 f/u t103, weakness, cough, diarrhea for 3 days; vax did not provided immunization;									Y	10/15/1992	03/03/1993	139		PVT	PVT	Maxide;	NONE	hx of viral myocarditis;	pt exp localized react to inject, plus 24hr of flu-like sx (fever, runny nose,)~ ()~~~In patient	CO4719	1						1	Asthenia; Cough; Diarrhoea; Drug ineffective; Infection; Influenza; Malaise; Pyrexia	FLU3~PARKE-DAVIS~2F31003~2~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0056820	10/28/1993	KY	20.0			F	10/11/1993	vasovagal episode & poss anaphylaxis are reported in pt who recvd flu vax; 1 hr p/vax found on the floor not breathing & w/no heartbeat; DPH given & CPR & 02 were administered;			Y							10/08/1993	10/08/1993	0	NS	OTH	OTH	Pt recvd Hep B vax;	NS	NS	NS~ ()~~~In patient	26989	1						1	Anaphylactoid reaction; Apnoea; Cardiac arrest; Syncope; Apnoea; Cardiac arrest; Stupor	FLU3~PARKE-DAVIS~01173P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~01173P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Life Threatening	Influenza
0056831	10/28/1993	OH	61.0	60		F	10/25/1993	transient blindness; optic neuritis; vax given 27SEP93; blindness occurred 14OCT93; same problem last year; vax given 16SEP92, blindness occurred 6OCT92;					Y	4			Y	09/27/1993	10/11/1993	14	Objective blindness;	PVT	PVT	Diabeta, Procardia, Micock;	NONE	No known allergies;	NONE~ ()~~~In patient		1						1	Optic neuritis; Visual disturbance	FLU3~CONNAUGHT LABORATORIES~3F41114~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0056832	10/28/1993	MI	87.0	87		F	10/20/1993	ascending paralysis, w/resp failure, consistant w/GBS;	Y	10/14/1993		Y	Y	4			N	10/01/1993	10/11/1993	10	LP-nl; EMG-nl; consistant w/GBS:	PVT	PVT	Dyazide-Micro K; Ventolin-Aero Bid uniphyl;	NONE	bronchial asthma, hypertensive cardio vascular disease;	~ ()~~~In patient		1						1	Apnoea; Guillain-Barre syndrome; Paralysis	FLU3~PARKE-DAVIS~00863P~1~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0056836	10/28/1993	DC	39.0	39		F	10/27/1993	20 mins post vax devel warmness & pruritus over entire body; DPH given; no hives noted;									Y	10/08/1993	10/08/1993	0	NONE	PUB	PUB	NONE	NONE	TEtracycline	NONE~ ()~~~In patient		1						1	Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3J41146~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056837	10/28/1993	IL	66.0			F	10/18/1993	Soreness on left arm, hoarseness & sore throat; severe blood shot eyes, aching body;									Y	10/15/1993	10/15/1993	0		PUB	PUB	took DPH from PMD:	NONE	NONE	Rxn in pt, age 64-65;~ ()~~~In patient	IL93118	1						1	Conjunctivitis; Dysphonia; Myalgia; Pharyngitis	FLU3~PARKE-DAVIS~10273P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0056838	10/28/1993	TX	49.0	49		U	10/19/1993	felt fine day of & immed following vax; 2 days p/vax devel rash @ site of flu shot, fever, stomach cramps; 19OCT93 rash had spread to hands, scalp & trunk; site of flu shot is darkened & covered w/a fine rash;									U	10/15/1993	10/17/1993	2	NONE	OTH	PVT	Equifac	allergies	allergic to Betadine scrub	~ ()~~~In patient		1						1	Abdominal pain; Injection site hypersensitivity; Pyrexia; Rash; Skin discolouration	FLU3~CONNAUGHT LABORATORIES~3F41009~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~LEDERLE LABORATORIES~334901~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0056839	10/28/1993	NY	38.0	38		M	10/23/1993	generalized muscle soreness upper lower extremities;									Y	10/22/1993	10/23/1993	1		PUB	OTH	NA	NONE	NA	~ ()~~~In patient		1						1	Myalgia	FLU3~PARKE-DAVIS~00583P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0056840	10/28/1993	NJ	7.0	7		M	10/20/1993	12 hrs post vax devel 105 temp (2 days); given APAP;									Y	10/11/1993	10/11/1993	0	NA	PVT	PVT	Slo zbid; Vancenase;		asthma & allergic rhinitis;	NONE~ ()~~~In patient		1						1	Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41141~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056841	10/28/1993	AZ	56.0	56		F	10/25/1993	moderately severe local reaction in lt arm w/heat, swelling & pain;									Y	10/20/1993	10/21/1993	1		PVT	UNK	Procardia/Lopid; Mevaes;	NONE		~ ()~~~In patient		1						1	Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41172~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~362967~1~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0056842	10/28/1993	MN	62.0	62		M	10/25/1993	twitching or jerking of both hands; observe next few days report number of times jerking occurs in a day;									U	10/22/1993	10/23/1993	1		PVT	PVT	Cardizem; Hordil;	NONE		~ ()~~~In patient		1						1	Muscle twitching	FLU3~CONNAUGHT LABORATORIES~3F41003~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057068	10/28/1993	IL	61.0	61		F	09/14/1993	pt recvd vax & exp swelling, heat & redness in the arm of inject extending up to the clavicle & into the neck;									Y	09/28/1992	10/01/1992	3		PVT	PVT	Procardia XL, Glynase, Theodur;	UNK	Hypertension, obesity; allergic to penicillin;	~ ()~~~In patient	893264003J	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Neck pain; Oedema; Pain; Vasodilatation	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057069	10/28/1993	OR	37.0	37		F	07/27/1993	pt recvd vax 8OCT93 & 1 wk later devel a polyneuropathy characterized by vague progressive numbness on the lt side more than on the rt side, tingling electrical dysesthenia in all 4 extremities, h/a, fatigue, difficulty thinking/concentrat				Y					N	10/08/1992	10/13/1992	5	Thyroid function tests, B12, Serum chemistry panel, CBc, urinalysis, ANA, lead level, sed rate, protein electrophoresis, complement studies VDRL, CXR, MRI of the brain were all nl;	PVT	PVT	NONE	NONE	pt has occular sensivivity to thimerosal;	~ ()~~~In patient	893215001K	1						1	Asthenia; Headache; Hypertonia; Muscle twitching; Neuropathy; Paraesthesia; Thinking abnormal	FLUX~PFIZER\WYETH~4918147~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0056848	10/29/1993	OH				F	10/15/1993	pt recvd flu vax devel GBS; as of the date of this report pt still has residual paralysis of rt foot & leg;								Y	N	11/21/1991				OTH	OTH	UNK	unk		~ ()~~~In patient	893292006J	1						1	Guillain-Barre syndrome; Paralysis	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0056851	10/29/1993	MD	47.0	47		M	10/29/1993	roommate called victim's job to say that had become ill @ 230 AM & died @ home; CPR recvd; c/o indigestion, vomited 3-4 times over 20 min period; fell & hit chin on toilet bowl, turned blue, eyes glazed over, breathing stopped; heart attack	Y	10/29/1993							N	10/28/1993	10/29/1993	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MD93041	1						1	Apnoea; Arteriosclerosis; Cardiac arrest; Cardiovascular disorder; Dyspepsia; Injury; Stupor; Vomiting; Apnoea; Cardiovascular disorder; Cyanosis; Dyspepsia; Malaise; Stupor; Vomiting	FLU3~CONNAUGHT LABORATORIES~3F41035~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~3F41035~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0056852	10/29/1993	MD	3.0	2	.9	F	10/29/1993	had only pain @ inject site until sz; no fever until sz; pt had sz @ the dinner table; eyes rolled back; shoulders clenched, body started trembling; face turned blue; sx lasted 3 mins; breathing stopped but resumed; t104.7 R; no eye contact				Y					Y	10/27/1993	10/28/1993	1	TC neg; blood work neg; CXR neg;	PUB	PUB	NONE	NONE	prematurity, bronchialitis, asthma;	NONE~ ()~~~In patient	MD93042	1						1	Apnoea; Convulsion; Cyanosis; Gaze palsy; Hypertonia; Injection site pain; Pyrexia; Stupor; Apnoea; Convulsion; Cyanosis; Gaze palsy; Hypertonia; Injection site pain; Pyrexia; Stupor	FLU3~CONNAUGHT LABORATORIES~3F41124~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~3F41124~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0056854	10/29/1993	MO	60.0	60		M	10/28/1993	pt is hospitalized; dx GBS 19OCT93 pt had funny feeling, salty taste in mouth, tingling weakness in legs; adm to hosp 22OCT93 ascending paralysis;, difficulty swallowing & breathing; intubated 27OCT93;			Y	Y	Y				N	10/05/1993	10/19/1993	14	plasmaphoresis done;	OTH	PVT	Cholesterol lowering med;	borderline hypertension;	NONE	~ ()~~~In patient		1						1	Dysgeusia; Dysphagia; Dyspnoea; Guillain-Barre syndrome; Myasthenic syndrome; Paraesthesia; Paralysis; Paralysis flaccid; Guillain-Barre syndrome; Respiratory disorder	FLUX~PFIZER\WYETH~4938254~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation	Influenza
0056855	10/29/1993	PA	55.0	54		M	10/20/1993	low back pain, pharyngitis, lower extremity weakness;				Y	Y	2				09/06/1993	09/16/1993	10	GBS confirmed;	OTH	OTH				~ ()~~~In patient		1						1	Back pain; Guillain-Barre syndrome; Myasthenic syndrome; Pharyngitis	FLUX~UNKNOWN MANUFACTURER~4938143~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0056856	10/29/1993	OR	41.0	41		F	10/18/1993	11OCT93 became irritable, had boyd aches, felt feverish, congested, coughing up bright green mucous; sl constipation; had lump on lt side of neck which became larger;									U	10/07/1993	10/11/1993	4	NONE	PUB	PVT	Premarin; Ventolin	NONE	food allergies as a child-bronchitis-asthma;	NA~ ()~~~In patient		1						1	Agitation; Constipation; Cough; Myalgia; Pyrexia; Rhinitis; Skin nodule	FLUX~PFIZER\WYETH~4938137~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056857	10/29/1993	FL	56.0	56		F	10/22/1993	deltoid arm area became red swollen, hard & hot & painful;									Y	10/18/1993	10/21/1993	3	Sxs noted;	OTH	PUB	NONE	NONE	COPD	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PARKE-DAVIS~60963P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0056858	10/29/1993	FL	57.0	57		F	10/25/1993	progressive pain on lt upper extremities since recvd flu vax 21OCT93;										10/21/1993	10/22/1993	1		UNK	UNK	NONE	NONE	Talwin, Lidocaine	~ ()~~~In patient		1						1	Injection site pain	FLU3~CONNAUGHT LABORATORIES~3F41123~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056865	11/01/1993	MA	65.0	65		F	10/14/1993	severe h/a started evening of 12OCT p/recvng flu shot; went to hosp; CT Scan; lasted about 24 hrs;				Y					Y	10/12/1993	10/12/1993	0		OTH	UNK		NONE	Prednisone for temporal arteritis;	~ ()~~~In patient	MA9348	1						1	Headache	FLU3~CONNAUGHT LABORATORIES~3F41172~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0056866	11/01/1993	MA	62.0	62		F	10/19/1993	24 hrs p/vax pt exp severe h/a w/vomiting migrane type; pt has no hx of h/a; lasted 24 hrs severe mild next 36 hrs; accompanied by weakness;									Y	10/13/1993	10/14/1993	1		PUB	UNK		NONE	upper resp allergies; dust mites, ragweed;	~ ()~~~In patient	MA9349	1						1	Asthenia; Headache; Migraine; Vomiting	FLUX~PFIZER\WYETH~4938083~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056867	11/01/1993	ME	41.0	40		F	10/22/1993	arm felt hot, vomiting, dizzy, fainted;									Y	10/21/1993	10/21/1993	0	NA	PUB	PVT	NONE	NONE	allergic to choc;	NA~ ()~~~In patient	ME93042	1						1	Dizziness; Syncope; Vasodilatation; Vomiting	FLUX~PFIZER\WYETH~4398124~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056869	11/01/1993	ME	38.0	38		M	10/22/1993	dizzy, achy, fever, sick to stomach w/in 24 hrs lasted x 3 days;									Y	10/14/1993	10/15/1993	1	NA	UNK	UNK	NONE	NONE	NONE	NA~ ()~~~In patient	ME93044	1						1	Dizziness; Dyspepsia; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~4938217~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056870	11/01/1993	MA	66.0	66		F	10/26/1993	25OCT in PM lt arm itchy, swollen, hot; 26OCT lt arm more swollen about size of 2 eggs, red, hot, hurts when touched;									N	10/18/1993	10/25/1993	7	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	ME93045	1						1	Oedema peripheral; Pain; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~4938089~6~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~PFIZER\WYETH~4938072~1~~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0056872	11/01/1993	NH	55.0	55		F	10/26/1993	hives around eyes;									Y	10/19/1993	10/20/1993	1		PVT	OTH		NONE	NONE	~ ()~~~In patient	NH93019	1						1	Urticaria	FLUX~PFIZER\WYETH~4938124~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056896	11/01/1993	TX	60.0	60		F	10/08/1993	discomfort w/inject noticed in evening & swelling redness hot to touch all upper arm;									Y	10/07/1993	10/07/1993	0	NONE	PUB	PUB			inc cholesterol & hx HPN-hx previous renal failure	~ ()~~~In patient	TX93171	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41009~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~357967~UNK~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0056899	11/01/1993	TX	88.0	88		F	10/13/1993	30 mins p/vax pt devel swelling in rt neck that resembled mumps; allerg react; rt neck swelling;				Y					Y	10/13/1993	10/13/1993	0	NONE	PUB	PUB	research study for alzheimers daughter didn't know what research;	NONE	alzheimers	NONE~ ()~~~In patient	TX93175	1						1	Hypersensitivity; Oedema; Parotid gland enlargement	FLU3~CONNAUGHT LABORATORIES~3F41009~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0056900	11/01/1993	TX	57.0	57		F	10/13/1993	high fever, started Friday evening 8OCT93; hives 9OCT93;				Y					Y	10/05/1993	10/08/1993	3		OTH	PUB	NONE	NONE	allergic to PCN, Ceclor (hives);	pt exp temp, inc swelling @ 7yrs w/DTP #4;~ ()~~~In patient	TX93176	1						1	Pyrexia; Urticaria	FLU3~CONNAUGHT LABORATORIES~3F41009~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0056905	11/01/1993	TX	41.0	41		F	10/18/1993	pt states that w/in 2 hrs of receiving the flu vax had a rash on arm where vax was administered & itched; eyes were swollen & began to have bad h/a;									Y	10/15/1993	10/15/1993	0		PUB	PUB				~ ()~~~In patient	TX93181	1						1	Face oedema; Headache; Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~3F41009~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056908	11/01/1993	TX	71.0	71		F	10/20/1993	immed p/receiving vax arm tender to touch redness & swelling @ site;									Y	10/18/1993	10/18/1993	0	NA	PUB	PUB	NONE	NONE		NA~ ()~~~In patient	TX93184	1						1	Injection site hypersensitivity; Injection site oedema; Pain	FLU3~PARKE-DAVIS~00573P~3~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~336942~1~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0056912	11/01/1993	VA	50.0	50		F	10/26/1993	pt recvd vax 11OCT93 immed p/vax felt nauseated; 12OCT93 woke up w/numb lips; felt big but did not appear swollen;									Y	10/11/1993	10/11/1993	0	NA	PUB	PVT	Mandelamine; Vitamin C;		allergic & Ioidne IVP dye, PCN, sulfa, codiene, Premarin, Estiax;	~ ()~~~In patient	VA93083	1						1	Nausea; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~3F541032~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056913	11/01/1993	CA	71.0	71		F	10/25/1993	swelling, itching, fever 104.8 2 days; had to enter hosp upset stomach, diarrhea;				Y	Y	3			Y	10/05/1993	10/05/1993	0		PUB	PUB	NONE	NONE		NONE~ ()~~~In patient	CA93089	1						1	Diarrhoea; Dyspepsia; Oedema; Pruritus; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0056915	11/01/1993	CT	60.0	60		M	10/28/1993	chief c/o weakness, back pain, flank pain, radiculitis, ataxic gait, paralumbar pain dx w/GBS:				Y	Y				N	10/08/1993	10/22/1993	14	elevated CSF portein w;nl CSF WBC count;	PVT	OTH			diabetes hypetension, COPD, peripheral vascular disease;	~ ()~~~In patient		1						1	Asthenia; Back pain; CSF test abnormal; Coordination abnormal; Guillain-Barre syndrome; Neuritis	FLUX~UNKNOWN MANUFACTURER~~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0056916	11/01/1993	NY	35.0	35		M	10/26/1993	10 mins p/vax difficulty breathing, throat felt like it was closing, pale, sweating clammy, wheezing on exam vitals WNL;			Y						Y	10/20/1993	10/20/1993	0	NONE	OTH	PVT		NONE	NONE	NONE~ ()~~~In patient		1						1	Asthma; Dyspnoea; Hyperhidrosis; Laryngospasm; Pallor	FLU3~CONNAUGHT LABORATORIES~3F41122~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0056919	11/01/1993	NC	67.0	67		M	10/27/1993	29SEP93 1800 vax given; 30SPE93 0830 pt nonresponsive to any stimuli; 1OCT93 0300 pt expired; COD hypertensive cardiovascular disease;	Y	10/01/1993							N	09/29/1993	09/30/1993	1		PVT	PVT	Prolixin;	PVC/head injury;	hx of ventricular arrhythmia; chronic dementia, diabetes, CHF;	~ ()~~~In patient		1						1	Cardiovascular disorder; Hypertension; Stupor	FLUX~PFIZER\WYETH~4938147~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0056922	11/01/1993	CA	61.0	61		F	10/26/1993	11PM 21OCT93 spoke to MD seen on 22OCT93; given cortisone shot in hip & 2 days of Pred; started w/extreme pain in rt arm & sl swollen; next day t101; arm warm devel 5x3 lump above crook of elbow; limited ROM;				Y					Y	10/21/1993	10/21/1993	0	NONE	PUB	PUB	NONE	NONE	Crohn's disease	~ ()~~~In patient	CA93090	1						1	Hypokinesia; Injection site mass; Oedema peripheral; Pain; Pyrexia; Vasodilatation	FLUX~PFIZER\WYETH~4938149~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~359958~UNK~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0056923	11/01/1993	CA	62.0	62		F	10/19/1993	swelling started by 1PM; sore & discomfort; stiff was sewing got progressively worse; 7PM decided to go to ER: rt arm swelling from shoulder to below elbow; was red, hot & very painful;				Y					Y	10/18/1993	10/18/1993	0	NONE	PUB	PUB	NONE	NONE	emphysema;	~ ()~~~In patient	CA93091	1						1	Hypertonia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema; Pain; Vasodilatation	FLUX~PFIZER\WYETH~4938142~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~330949~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0056930	11/01/1993	SD	31.0	31		F	10/28/1993	started feeling achy 8OCT 6PM while shopping rapidly progressed w/inc temp by 730PM; chills ache all over; severe h/a; temp up to 103.4; sx persisted thru 11OCT til later PM;									Y	10/06/1993	10/08/1993	2	CBC & UA:	PVT	PVT	NONE	NO problems	NONE	NONE~ ()~~~In patient		1						1	Chills; Headache; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~4938150~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056933	11/01/1993	PA	25.0	25		F	10/27/1993	pt recvd vax & arm swollen, red & sore for 3rd day; severe h/a upon awakining, lasted all day; severe diarrhea until 21:15; severe arthritic sx in hips, could not walk; all joints hurt bad, elbows esp swollen, red, & warm;									U	10/11/1993	10/14/1993	3	lyme AB-neg;	MIL	UNK	NONE	occasional sl arthr sx in hips;	occasional sl arthr sx in hips;	~ ()~~~In patient		1						1	Arthralgia; Arthritis; Condition aggravated; Diarrhoea; Headache; Hypokinesia; Oedema peripheral; Osteoarthritis	FLUX~PFIZER\WYETH~4938158~5~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056935	11/01/1993	WI	63.0	63		F	10/26/1993	pt reported 6x6 swelling & redness;									Y	10/12/1993	10/12/1993	0	pt did not return to clinic;	PVT	UNK		NONE	NONE	pt exp rx OCT92 5x7 & FEB92 4x4 w/flu vax;~ ()~~~In patient		1						1	Oedema; Vasodilatation	FLUX~PFIZER\WYETH~4938086~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056937	11/01/1993	MO	28.0			F	10/26/1993	about 10 mins p/vax had profuse diaphoresis & felt like was going to faint;									Y	10/01/1993	10/01/1993	0	NA	PVT	PVT	NONE	lower intestinal cramps/diarrhea	UNK	~ ()~~~In patient		1						1	Dizziness; Hyperhidrosis	FLUX~PFIZER\WYETH~4938150~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056939	11/01/1993	VA	65.0	65		F	10/25/1993	pt devel herpes zoster lesions rt chest, axilla, back 3 days p/flu vax given;									Y	10/11/1993	10/14/1993	3		OTH	OTH	erytabs, Seldane;	NONE	allergic to retina/PCN/TCN;	~ ()~~~In patient		1						1	Herpes zoster	FLU3~CONNAUGHT LABORATORIES~3F41027~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056946	11/01/1993	CA	40.0	40		F	10/28/1993	sl nausea x 1 day, soreness @ inject site;  erythema & induration 48 hrs post inject 4x4 cm; rx DPH & ice packs;									Y	10/25/1993	10/27/1993	2	NONE	MIL	PVT	NONE	NONE	NONE	pt exp large induration in 1988 w/Tetanus;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Nausea	FLUX~PFIZER\WYETH~4938188~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056948	11/02/1993	SC	65.0	65		F	10/15/1993	pt had a cold & mild infect several wks prior to flu vax 7OCT93; exp malaise p/immun; 9OCT93 devel SOB was hospitalized & adm to ICU for 2-3 days; Dx: acute pulmonary edema;					Y	5			Y	10/07/1993	10/09/1993	2		PVT	OTH	Thyroid extract PRN, ASA, PRN;		Hx of mitral valve insufficiency & left bundle branch block;	~ ()~~~In patient	893293001J	1						1	Condition aggravated; Coronary artery disease; Dyspnoea; Malaise; Myocardial infarction; Pulmonary oedema	FLUX~PFIZER\WYETH~4938143~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0056949	11/02/1993	MD	21.0			F	10/14/1993	devel back pain, numbness of the fingers; both arms became weak; now has numbness from the breasts to pelvis; hospitalized on 12OCT93 to r/o vax related myilopathy & MS:					Y					10/06/1993	10/09/1993	3		UNK	UNK		unk		~ ()~~~In patient	CO5017	1						1	Back pain; Multiple sclerosis; Myasthenic syndrome; Myelitis; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~3F41033~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0056950	11/02/1993	NC	40.0	40		M	10/15/1993	weakness, dizziness, LOC, loss of balance; unable to stand, sit or lay on lt side; only able on rt side w/eyes closed; has had vax in past;				Y	Y	2			U	10/14/1993	10/14/1993	0		OTH	PVT	Tagamet	Sinusitis 3 weeks prior to vax;	Esophageal ulcer;	~ ()~~~In patient	CO5019	1						1	Asthenia; Condition aggravated; Coordination abnormal; Deafness; Dizziness; Nystagmus; Syncope; Vestibular disorder	FLU3~CONNAUGHT LABORATORIES~3F41123~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0056951	11/02/1993	OH	61.0	60		F	10/15/1993	sudden blindness-optic neuritis; same event happened last yr p/flu vax; 16SEp93 sc of sudden blindness/optic neuritis on 6OCT92; resolved p/steroid rx;					Y				N	09/27/1993	10/15/1993	18		UNK	UNK	Diabaster, Nifedapin;	NONE	diabetic	~ ()~~~In patient	CO5020	1						1	Blindness; Optic neuritis	FLU3~CONNAUGHT LABORATORIES~3F41114~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0056954	11/02/1993	NY	71.0	71		U	10/27/1993	GB synd 1 month post inject; adm to hsop is in stable conditon w/good resp function being treated; w/immune globulin;					Y				N	09/20/1993	10/23/1993	33		UNK	UNK			lupus like synd;	~ ()~~~In patient	CO5032	1						1	Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~3F41140~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0056955	11/02/1993	AK	41.0	41		F	10/02/1993	pt recvd vax lt deltoid 18OCT93 site aching p/vax; 19OCT993 aching, sore throat, lt side neck 730AM by 8PM chills, vomiting, h/a 20OCT93; chills alternating w/sweating; weak couldn't stand up; unability to focus x 3 days;				Y						10/18/1993	10/19/1993	1		PVT	PUB		NONE	allergic to Deseryl, barbituates;	~ ()~~~In patient	AK93022	1						1	Asthenia; Headache; Hyperhidrosis; Hypokinesia; Myalgia; Pharyngitis; Visual disturbance; Vomiting	FLUX~PFIZER\WYETH~4938226~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0056956	11/02/1993	AK	7.0	7		M	10/11/1993	pt is known asthmatic-sx inc in 24 hrs p/vax;					Y	2			Y	09/24/1993	09/24/1993	0	x-rays;	PUB	PUB	Proventil, Bromtel, Chromlice;	NONE	known asthmatic signs age 1 yr;	~ ()~~~In patient	AK93023	1						1	Condition aggravated	FLUX~PFIZER\WYETH~4938226~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0056957	11/02/1993	AK	67.0	67		F	10/07/1993	pt had flu vax 6OCT93 in the lt deltoid area; following evening noticed an area of redness & edema below & inside the area where the inject was given; pt states was bruised;									Y	10/06/1993	10/06/1993	0	NONE	PUB	PUB	pub	NONE		~ ()~~~In patient	AK93024	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4938226~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056958	11/02/1993	AK	53.0	53		F	10/07/1993	pt came to clinic the day p/vax fluid filled skin below & inside of the area when inject was given; The following day swelling nearly all gone;									Y	10/04/1993	10/05/1993	1	NONE	PUB	PUB		NONE	NONE	~ ()~~~In patient	AK93025	1						1	Injection site oedema	FLUX~PFIZER\WYETH~4938226~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~324954~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0056978	11/02/1993	WV	54.0	54		F	10/21/1993	15mins post vax broke out w/fine, red, itching rash on upper trunk & upper extremities; c/o pricking sensation; No SOB or resp distress;									Y	10/14/1993	10/14/1993	0	NONE	PUB	PUB	Coumadin	NONE	previous blood clots in lung;	~ ()~~~In patient	WV9333	1						1	Paraesthesia; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~3F41008~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0052404	11/03/1993	NY	39.0			F	08/18/1993	Pt recvd vax & approx 3 months p/vax exp h/a & poss transverse myelitis (numbness rt hand, weakness lt side);				Y	Y	19		Y	N	11/16/1992	02/05/1993	81	MRI-spinal cord lesion;	PVT	PVT	Entex;		allergies to novocain & cain drugs;	~ ()~~~In patient	EBU930447	1						2	Myelitis; Neuritis; Neuropathy; Pain; Abdominal pain; Chest pain; Headache; Multiple sclerosis; Myasthenic syndrome; Myelitis; Optic atrophy; Paraesthesia	HEP~SMITHKLINE BEECHAM~1021A4~2~IM~~HEP B (ENGERIX-B)~1|FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|HEP~SMITHKLINE BEECHAM~1021A4~2~IM A~~HEP B (ENGERIX-B)~2	USA	Hospitalisation,Disabling	Influenza
0056981	11/03/1993	NV	25.0	25		M	10/21/1993	19OCT93 vomiting, fever (100), achiness, dizziness, nausea to present 21OCT93 820AM; states redness & swelling below inject sites dec; area has 5 blotchy red areas no longer swollen; muscle aches, h/a, n/v dec;									U	10/18/1993	10/19/1993	1	NONE	PUB	PUB	Nasal Spray-Afrin	tired, rundown past 2 wks;	hiatal hernia; nasal allergies;	pt exp flu like sx x 2 days @ 21 w/MMR booster;~ ()~~~In patient	NV93031	1						1	Dizziness; Headache; Injection site hypersensitivity; Injection site oedema; Myalgia; Nausea; Pyrexia; Vomiting	FLUX~PFIZER\WYETH~4938156~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~336943~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0056982	11/03/1993	NV	39.0	39		F	10/22/1993	evening arm became sore; PM became nauseated, aching; 4PM began vomitting, & fainted @ 6PM; abdo cramps, diarrhea began; shaky weak, but better;									Y	10/19/1993	10/20/1993	1	NA	PUB	UNK	Estrogen replacement therapy;	NONE	NONE	NA~ ()~~~In patient	NV93032	1						1	Abdominal pain; Asthenia; Diarrhoea; Myalgia; Nausea; Syncope; Tremor; Vomiting	FLUX~PFIZER\WYETH~4938156~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056985	11/03/1993	VA	78.0	78		F	10/27/1993	pt stated lt arm had small bruise @ site where inject was given; lt arm red & swollen about 2 inches wide by 5 inches long;										10/26/1993	10/27/1993	1		PUB	PUB		NONE	NONE	~ ()~~~In patient	VA93084	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~3F41172~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056986	11/03/1993	FL	69.0	68		M		GBS by report approx 10 days or 12 days p/flu vax given 14OCT93;			Y	Y	Y	42			Y	10/14/1993	10/21/1993	7		PVT	UNK		NONE	Diverticulum;	NA~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~3F41123~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0056987	11/03/1993	MI	78.0	78		M	11/01/1993	Pt recvd vax 13OCT93 & was seen again on 20OCT93 w/lt sided facial palsy whicch had devel subsequent to the vax;									U	10/13/1993	10/20/1993	7		PVT	PVT	Vit B12 inject		(NIDDM) diabetes, storke (old), prostatic Carcinoma, Bell's palsy;	~ ()~~~In patient		1						1	Facial palsy	FLUX~PFIZER\WYETH~4938187~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056988	11/03/1993	MI	48.0	47		F	10/29/1993	large, raised & reddened area 96 x 4) surrounding inject site; inc warmth, tenderness w/sl itchy sensation in affected area; sx duration x 4 days, sx have slowly resolved;									Y	10/19/1993	10/20/1993	1		PVT	PVT	Synthroid	NONE	hypothyroidism;	pt exp local swelling @ 18 y/o w/Tetanus & rxn w/tetanus @ 5 yrs old;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0056991	11/03/1993	FL	15.0	15		F	10/22/1993	flu shot given on 18OCT93 approx 415PM; around MN pt awoke w/fever fo 106; ran fever next day up to 104 & day p/of 100; h/a, nausea, lethargy;								Y	Y	10/18/1993	10/19/1993	1		PVT	PVT	NONE	denies	allergic to PCN; hx of asthma;	NONE~ ()~~~In patient		1						1	Headache; Nausea; Pyrexia; Somnolence	FLU3~CONNAUGHT LABORATORIES~3F41028~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0056997	11/04/1993	ME	31.0	31		F	10/27/1993	h/a, fatigue, arm swollen to size of about a half dollar, red & sore, diarrhea, lack of appetite;				Y					N	10/25/1993	10/26/1993	1	temp nl;	PVT	PVT	Lorzepam	NONE	NONE	NONE~ ()~~~In patient	ME93046	1						1	Anorexia; Asthenia; Diarrhoea; Headache; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~4938119~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0056998	11/04/1993	ME	51.0	51		F	10/27/1993	20OCT-21OCT dull h/a; 23OCT diarrhea, achy all over, heavy feeling; 24OCT no appetite, heavy feeling, aching in muscles & joints; 25OCT missed work because still not feeling well; 26OCT stomach cramps; 27OCT no appetite sore throat;									N	10/19/1993	10/20/1993	1	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	ME93047	1						1	Abdominal pain; Anorexia; Arthralgia; Asthenia; Diarrhoea; Headache; Myalgia; Pharyngitis	FLUX~PFIZER\WYETH~4938119~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057003	11/04/1993	OH	78.0	78		F	10/28/1993	hypotension, mild dehydration; fever up to 101, myalgia, malaise;				Y					Y	10/11/1993	10/11/1993	0	NONE	PVT	PVT	Pepcia, HCTZ, APAP, Plaqudil, Bactrim for sinisitis;	11OCT93 rhinorrhea, sinusitis	allergy to PCn; hx Sjorens synd, hypertension	~ ()~~~In patient		1						1	Dehydration; Hypotension; Malaise; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41142~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0057006	11/04/1993	MI	29.0	28		F	10/14/1993	w/in 3 hrs of inject pt c/o nausea, abdo pain, body aches, dizziness & chills; no local react @ inject site; lasted about 20 hrs; temp unk;									Y	10/08/1993	10/08/1993	0		PVT	OTH	Dyazide, Seldane	NONE	PCN, Ceclor	NONE~ ()~~~In patient		1						1	Abdominal pain; Chills; Dizziness; Myalgia; Nausea	FLU3~CONNAUGHT LABORATORIES~3F41035~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057007	11/04/1993	MA	54.0	54		M	10/26/1993	had sot @ 130PM & about 8PM started getting sick for 3 days p/, vomit, sick to stomach;									Y	10/01/1993	10/01/1993	0		OTH	UNK		NONE		~ ()~~~In patient		1						1	Dyspepsia; Malaise; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057008	11/05/1993	AZ	71.0	71		F	10/18/1993	died p/being hospitalized for interstitial pneumonia; day p/vax felt SOB & started to cough; 5OCt admitted;	Y	10/08/1993			Y	3			N	09/30/1993	10/01/1993	1	family refused autopsy;	UNK	UNK	Prednisone; Methotrexate;		pulmonary fibrosis, past hx TB, theumatoid arthritis;	~ ()~~~In patient	CO5040	1						1	Cough; Dyspnoea; Hyperventilation; Hypocalcaemia; Leukocytosis; Pneumonia; Pyrexia; Tachycardia	FLU3~CONNAUGHT LABORATORIES~3F41007~4~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0057009	11/05/1993	OH	27.0			F	10/28/1993	tachycardia, flushing, lightedness, chest heaviness about 1/2 hrs p/shot; seen in ER then released; 22OCT93 cont to feel unwell; seen in ER again 23OCT93 & adm to hosp;				Y	Y	2			Y	10/21/1993	10/21/1993	0		UNK	UNK				~ ()~~~In patient	CO5063	1						1	Chest pain; Dizziness; Malaise; Tachycardia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0057011	11/05/1993	PA	71.0			M	10/25/1993	pt recvd vax 5OCT93 & was admitted to hosp 18OCT93 to r/o encephalitis; pt is in ICu in a comatose state;					Y				U	10/05/1993				OTH	OTH	UNK	UNK		~ ()~~~In patient	893299001C	1						1	Coma; Encephalitis	FLUX~PFIZER\WYETH~4938255~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0057012	11/05/1993	IL	80.0	79		M	10/21/1993	pt recvd vax 18OCT93 & 20OCT93 was admitted to the hosp for eval of memory loss & confusion;				Y	Y				U	10/18/1993	10/20/1993	2		OTH	OTH	eye drops	unk		~ ()~~~In patient	893298001J	1						1	Amnesia; Confusional state; Amnesia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~3F41010~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0057013	11/05/1993	NJ	67.0	67		F	11/01/1993	pneumonia & flu-like sx are reported in pt who recvd flu vax; pt exp aches & the following day exp fever & chills; sx abated w/APAP;					Y				U	09/27/1993	10/01/1993	4	Chest CT Scan prior to flu vax was neg;	OTH	OTH	NONE	NONE	allergy to sulfa; pneumonia	~ ()~~~In patient	26812	1						1	Asthenia; Chills; Condition aggravated; Infection; Influenza; Myalgia; Pyrexia	FLU3~PARKE-DAVIS~~7+~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0057022	11/05/1993	TN	46.0	46		F	10/25/1993	low grade fever, flu sx, sick to stomach, congestion in chest;										10/20/1993	10/22/1993	2		PUB	PUB				~ ()~~~In patient	TN93100	1						1	Dyspepsia; Influenza; Lung disorder; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41033~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057023	11/05/1993	TN	59.0	59		F	10/25/1993	allergic react 8 inch area (band almost around arm); hot, itchy, swollen hard;				Y						10/20/1993	10/21/1993	1		PUB	PUB				~ ()~~~In patient	TN93101	1						1	Hypersensitivity; Injection site hypersensitivity; Injection site mass; Injection site oedema; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41033~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0057024	11/05/1993	TN	34.0	34		F	10/26/1993	itchy back of neck; rash looks like heat rash (whelps); swollen node on neck (small); congestion;									Y	10/22/1993	10/23/1993	1	NA	PUB	PUB	NA	NA	NA	~ ()~~~In patient	TN93102	1						1	Lymphadenopathy; Pruritus; Rash; Rhinitis; Urticaria	FLUX~PFIZER\WYETH~49382621~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057025	11/05/1993	TN	73.0	73		M	10/26/1993	cough 1 wk p/shot; h/a, congestion 1 wk p/shot & cold like; no fever (temp not taken);										10/15/1993	10/22/1993	7	NA	PUB	PUB	diabetic, High blood pressure, insulin;	NA	diabetes, high blood pressure;	~ ()~~~In patient	TN93103	1						1	Cough; Headache; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4938183~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057026	11/05/1993	TN	78.0	77		F	10/28/1993	chest pains, adm to hosp has enlarged heart;					Y	3				10/20/1993	10/24/1993	4		PUB	PUB				~ ()~~~In patient	TN93104	1						1	Cardiomegaly; Chest pain	FLUX~PFIZER\WYETH~4938183~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~360961~UNK~~RA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0057028	11/05/1993	TX	60.0	60		M	11/01/1993	pt reported to MD had nickle-size blister on the lt arm where flu vax was administered; MD reported to clinc that pt had lemon size redness & swelling in the same area; also reported 1/4-1/2 hole in this area;				Y					Y	10/15/1993	10/19/1993	4		PUB	PUB				~ ()~~~In patient	TX93199	1						1	Injection site atrophy; Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~3F41009~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~356942~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0057029	11/05/1993	OH	79.0	79		F	10/26/1993	pt recvd flu vax 30SEP93 & was noted to be acting out of character by family including some hallucinations & belligerence toward family; pt also noted to be very sedate @ times; adm to hosp 4OCT(3 w/low grade fever;					Y					09/30/1993	10/01/1993	1	nl WBC & differential 88.1/11.3/33;277; nl cxr;	UNK	UNK			hx of CVA, NIDDM, HTN; NKA;	~ ()~~~In patient		1						1	Hallucination; Hostility; Personality disorder; Pyrexia; Somnolence	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0057030	11/05/1993	UT	31.0	31		F	11/01/1993	3 days p/flu vax pt exp rt leg weakness & numbness; pt hospitalized;				Y	Y				N	10/18/1993	10/21/1993	3		PVT	PVT	NONE	URI	NONE	~ ()~~~In patient		1						1	Myasthenic syndrome; Paraesthesia; Myasthenic syndrome; Paraesthesia	FLUX~PFIZER\WYETH~4938137~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938137~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0057032	11/05/1993	MI	78.0	77		M	11/01/1993	hospitalized; dx encephalitis;					Y				Y	09/13/1993				UNK	UNK				~ ()~~~In patient		1						1	Encephalitis	FLUX~PFIZER\WYETH~4938141~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0057033	11/05/1993	MI				M	11/01/1993											09/13/1993				UNK	UNK				~ ()~~~In patient		1						1	Unevaluable event	FLUX~PFIZER\WYETH~4938141~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057036	11/05/1993	NC	39.0			F	11/02/1993	burning sensation from site of inject to bend in elbow; for several wks aching, throbbing of arm from inject site to the bend in the elbow;														MIL	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site pain	FLU3~PARKE-DAVIS~00783P~3~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057037	11/05/1993		72.0			M	10/23/1993	pt recvd flu vax & devel generalized itching; treated w/DPH;										10/23/1993	10/23/1993	0		UNK	UNK	Gluctoloe, Phozyme, Lanoxin, Isordid, Metamucil, K Tab, Zaropolyn, Vastin, Taradol, Tertrarydine, Lasix;			~ ()~~~In patient		1						1	Pruritus	FLUX~PFIZER\WYETH~4938254~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057075	11/05/1993	NJ				F	09/13/1993	Pt recvd vax & several other unspecified vax in a study of immunocompetence; subsequently devel induration & warmth @ the inject site; pain, induration & hyprthermia were felt to have occurred @ SC injection site of neo-antigen KLH;									U					OTH	OTH	KLH (neo-antigen) injected SC;			~ ()~~~In patient	893264001J	1						1	Injection site mass; Vasodilatation	FLUX~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0057076	11/05/1993	NJ				U	09/13/1993	Pt recvd vax & devel induration & warmth @ the inject site;									U					OTH	OTH		unk		~ ()~~~In patient	893264004J	1						1	Injection site mass; Vasodilatation	FLUX~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057077	11/05/1993	OR				M	09/24/1993	pt recvd vax & devel a rash on the thigh & arm; pt evaluated by dermatologist;				Y					U	09/20/1993				PVT	OTH	UNK	unk	pt had a similar react 15 years ago	~ ()~~~In patient	893279002J	1						1	Rash	FLUX~PFIZER\WYETH~4938152~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057078	11/05/1993	NC	52.0	52		M	09/29/1993	pt recvd vax & devel sl edema, itching, & redness @ inject site; pt was treated w/DPH;									U	09/29/1993	09/29/1993	0		OTH	PVT	NONE	unk		~ ()~~~In patient	893279003J	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLUX~PFIZER\WYETH~4938162~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057079	11/05/1993	NC	29.0	29		F	09/29/1993	pt recvd flu vax & devel sl edema & redness @ the inject site; pt also exp numbness; Pt treated w/DPH;									U	09/29/1993	09/29/1993	0		OTH	PVT	OCS	unk		~ ()~~~In patient	893279004J	1						1	Injection site hypersensitivity; Injection site oedema; Paraesthesia	FLUX~PFIZER\WYETH~4938162~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057080	11/05/1993	TX	74.0	74		F	09/30/1993	pt recvd vax & 30 minutes later devel swelling which inc the size of arm & which progressed to erythema to the elbow heat & induration; pt also devel lymphadenopathy, fever, sweating & h/a;				Y					U	09/21/1993	09/21/1993	0		PVT	OTH	UNK	unk		~ ()~~~In patient	893279005J	1						1	Headache; Hyperhidrosis; Lymphadenopathy; Oedema peripheral; Pyrexia; Rash; Skin nodule; Vasodilatation	FLUX~PFIZER\WYETH~4938144~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057081	11/05/1993	FL	32.0			U	09/29/1993	Pt recvd vax & exp painful stinging upon injection; next day the arm of inject was inflammed; Other pts recvd injects from the same lot w/o adverse reaction;									N	09/28/1993	09/28/1993	0		PVT	OTH	UNK	UNK	UNK	~ ()~~~In patient	893279006J	1						1	Injection site hypersensitivity; Injection site inflammation; Injection site oedema; Injection site pain; Pruritus	FLUX~PFIZER\WYETH~4938149~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057082	11/05/1993	FL	40.0	40		F	09/28/1993	Pt recvd vax Pt exp painful stinging upon inject; the next day of the arm of inject was inflammed; other pts recvd inject form the same lot w/no adverse reactions;									N	09/28/1993	09/28/1993	0		PVT	OTH	NONE	NONE		~ ()~~~In patient	893279007J	1						1	Cellulitis; Hypokinesia; Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Vasodilatation	FLUX~PFIZER\WYETH~4938149~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057083	11/05/1993	PA	41.0	41		F	09/28/1993	Pt recvd vax 23SEP93; the next day pt devel peripheral neuropathy in the feet, hands & chest; neurologic exam revealed lack of sensation to pin prick;				Y	Y	3			U	09/23/1993	09/24/1993	1		PVT	OTH	Motrin	none	none specified;	~ ()~~~In patient	893279008J	1						1	Myelitis; Paraesthesia	FLUX~PFIZER\WYETH~4938143~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0057084	11/05/1993	MI	55.0	55		F	09/17/1993	Pt recvd vax & 5 mins later became dizzy; The dizziness resolved; pt then devel redness & pain @ the inject site;									U	09/15/1993	09/15/1993	0		PVT	PUB	Diazide, Premarin, Wytenaih;	NONE		~ ()~~~In patient	893279009J	1						1	Dizziness; Injection site hypersensitivity; Injection site pain	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057085	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs the pt devel baseball-sized induration;									U	09/25/1993	09/27/1993	2		OTH	OTH	UNK	UNK		~ ()~~~In patient	893291001E	1						1	Skin nodule; Skin nodule	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0057085	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel baseball-sized induration;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291001E	1						2	Skin nodule; Skin nodule	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0057086	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs the pt devel baseball-sized induration;									U	09/25/1993	09/27/1993	2		OTH	OTH	UNK	unk		~ ()~~~In patient	893291002E	1						1	Skin nodule	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057087	11/05/1993					U	09/30/1993	Pt recvd flu vax & w/in 48 hrs pt devel baseball-sized induration;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291003E	1						1	Skin nodule	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057088	11/05/1993					U	09/30/1993	Pt recvd flu vax & w/in 48 hrs pt devel baseball-sized induration;									U	09/25/1993	09/27/1993	2		OTH	OTH	UNK	UNK		~ ()~~~In patient	893291004E	1						1	Skin nodule	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057089	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel baseball-sized induration;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291005E	1						1	Skin nodule	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057090	11/05/1993					U	09/30/1993	Pt recvd flu vax & w/in 48 hrs pt devel baseball-sized induration;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291006E	1						1	Skin nodule	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057091	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel baseball-sized induration;									U	09/25/1993	09/27/1993	2		OTH	OTH	UNK	UNK		~ ()~~~In patient	893291007E	1						1	Skin nodule	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057092	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel baseball-sized induration;									U	09/25/1993	09/27/1993	2		OTH	OTH	UNK	UNK		~ ()~~~In patient	893291008E	1						1	Skin nodule	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057093	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel baseball-sized induration;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291009E	1						1	Skin nodule	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057094	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel baseball-sized induration;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291010E	1						1	Skin nodule	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057096	11/05/1993					U	09/30/1993	Pt recvd flu vax & w/in 48 hrs pt devel baseball-sized induration;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291012E	1						1	Skin nodule	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057097	11/05/1993					U	09/30/1993	Pt recvd flu vax & w/in 48 hrs pt devel baseball-sized induration;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291013E	1						1	Skin nodule	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057098	11/05/1993					U	09/30/1993	Pt recvd flu vax & w/in 48 hrs pt devel baseball-sized induration;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291014E	1						1	Skin nodule	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057099	11/05/1993					U	09/30/1993	Pt recvd flu vax & w/in 48 hrs pt devel baseball-sized induration;									U	09/25/1993	09/27/1993	2		UNK	UNK				~ ()~~~In patient	893291015E	1						1	Skin nodule	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057100	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel baseball-sized induration;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291016E	1						1	Skin nodule	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057101	11/05/1993					U	09/30/1993	Pt recvd flu vax & w/in 48 hrs the pt devel baseball-sized induration;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291017E	1						1	Skin nodule	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057102	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel baseball-sized induration;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291018E	1						1	Skin nodule	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057103	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel baseball-sized induration;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291019E	1						1	Skin nodule	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057104	11/05/1993					U	09/30/1993	Pt recvd flu vax & w/in 48 hrs pt devel baseball-sized induration;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291020E	1						1	Skin nodule	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057105	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291021E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057106	11/05/1993					U	09/30/1993	pt recvd vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291022E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057107	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291023E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057108	11/05/1993					U	09/30/1993	pt recvd vax & w/in 48 hrs pt devel soreness @ inject site;;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291024E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057109	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291025E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057110	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	UNK	unk		~ ()~~~In patient	893291026E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057111	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291027E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057112	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291028E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057113	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291029E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057114	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs the pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291030E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057115	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291031E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057116	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291032E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057117	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs the pt developed soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291033E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057118	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291034E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057119	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291035E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057120	11/05/1993					U	09/30/1993	pt recvd vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291036E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057121	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291037E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057122	11/05/1993					U	09/30/1993	Pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291038E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057123	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291039E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057124	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291040E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057125	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291041E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057126	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291042E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057127	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291043E	1						1	Injection site pain	FLUX~PFIZER\WYETH~493186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057128	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291044E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057129	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291045E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057130	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291046E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057131	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291047E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057132	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291048E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057133	11/05/1993					U	09/30/1993	Pt recvd flu vax & w/in 48 hrs pt devel soreness @ the inject;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291049E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057134	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291050E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057135	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk	unk	~ ()~~~In patient	893291051E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057136	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291052E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057137	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291053E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057138	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291054E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057139	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291055E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057140	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291056E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057141	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291057E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057142	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291058E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057143	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291059E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057144	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291060E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057145	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	UNK		~ ()~~~In patient	893291061E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057146	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	UNK	unk	unk			893291062E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057147	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291063E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057148	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291064E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057149	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291065E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057150	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	UNK	UNK		~ ()~~~In patient	893291066E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057151	11/05/1993					U	09/30/1993	Pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	UNK	UNK		~ ()~~~In patient	893291067E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057152	11/05/1993					U	09/30/1993	pt recvd vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291068E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057153	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	UNK	unk		~ ()~~~In patient	893291069E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057154	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291070E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057155	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291071E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057156	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291072E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057157	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291073E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057158	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291074E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057159	11/05/1993					U	09/30/1993	pt recvd vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291075E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057160	11/05/1993					U	09/30/1993	pt recvd vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291076E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057161	11/05/1993					U	09/30/1993	pt recvd vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291077E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057162	11/05/1993					U	09/30/1993	pt recvd vax & w/in 48 hrs pt devel soreness @ the inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	UNK	unk		~ ()~~~In patient	893291078E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057163	11/05/1993					U	09/30/1993	pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291079E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057164	11/05/1993					U	09/30/1993	Pt recvd flu vax & w/in 48 hrs pt devel soreness @ inject site;									U	09/25/1993	09/27/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893291080E	1						1	Injection site pain	FLUX~PFIZER\WYETH~4938186~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0056851	11/08/1993	MD	47.0			M	11/01/1993	pt recvd vax & became ill @ 230AM & died @ home; CPR had been done by ambulance crew;  ROomate revealed that pt awoke 2AM c/o indigestion & vomited 3-4 times over 20 mins period;fell&hit chin turned blue, eyes glazed over&breathing stopped	Y	10/29/1993							N					PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	CO5090	1						2	Apnoea; Arteriosclerosis; Cardiac arrest; Cardiovascular disorder; Dyspepsia; Injury; Stupor; Vomiting; Apnoea; Cardiovascular disorder; Cyanosis; Dyspepsia; Malaise; Stupor; Vomiting	FLU3~CONNAUGHT LABORATORIES~3F41035~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~3F41035~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0056852	11/08/1993	MD	3.0	2	.9	F	11/01/1993	pt had only pain @ inject site until sz; no fever until sz; had sz @ dinner table, eyes rolled back, shoulders  clenched, body started trembling, face turned blue; breathing stopped but resumed p/CPR; t104.7 R;				Y					Y	10/27/1993	10/28/1993	1	TC eng; blood work neg, CXR neg;	PUB	PUB	NONE	NONE	prematurity, bronchialitis asthma;	~ ()~~~In patient	CO5089	1						2	Apnoea; Convulsion; Cyanosis; Gaze palsy; Hypertonia; Injection site pain; Pyrexia; Stupor; Apnoea; Convulsion; Cyanosis; Gaze palsy; Hypertonia; Injection site pain; Pyrexia; Stupor	FLU3~CONNAUGHT LABORATORIES~3F41124~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~3F41124~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0057165	11/08/1993	MA	89.0	89		F	10/18/1993	Pt recvd vax 8OCT93 & the next day was found in apartment in unresponsive state; adm to hosp w/fatigue & resp depression & intubated; on PE pt was febrile to 102 & generalized weakness; lab exam revealed elevated WBC count; LP nl, & CT					Y	12			N	10/08/1993	10/09/1993	1		OTH	OTH	Cardizem, Tegretol, Digoxin, Isodil, Persantine;	unk	hx of hypertension, COPD, & anterior wall infarction in 1981, was SP GI bleed w/subtotal gastrectomy, hx of abdominal aortic aneurysm, hip surgery, deep vein thrombosis, trigeminal neuralgia; questionable hx of allergies to PCN & erythromyc	NONE~ ()~~~In patient	893293002J	1						1	Condition aggravated; Encephalopathy; Hypoxia; Leukocytosis; Pneumonia; Respiratory acidosis; Somnolence; Stupor	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0057174	11/08/1993	NH	41.0	41		M	10/18/1993	febrile, gen malaise, muscle weakness x 24 hrs; no tx x/APAP;									Y	10/13/1993	10/14/1993	1	NONE	PUB	PVT		NONE	NONE	~ ()~~~In patient	NH93024	1						1	Malaise; Myasthenic syndrome; Pyrexia	FLUX~PFIZER\WYETH~4938086~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057178	11/08/1993	OK	62.0	62		F	10/18/1993	c/o lt arm paralized hurts so much unable to move it; home visit made; lt shoulder & arm very tender to palpation but no lumps; unable to squeeze hand very hard; eyes dull;										10/13/1993	10/14/1993	1		OTH	PUB	Hydroxyzine PAM cap; Trazodone;	NONE	dwarf paralized from waist down p/back surgery in AUG81; rt leg amputation 1985;	NONE~ ()~~~In patient	OK9354	1						1	Hypokinesia; Monoplegia; Myasthenic syndrome; Pain	FLUX~PFIZER\WYETH~4938153~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~340939~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0057180	11/08/1993	MA	63.0	63		M	10/31/1993	pt was shaking real bad & had chills; hosp found high bacteria in blood;				Y	Y	3			Y	10/19/1993	10/20/1993	1	high bacteria couunt in the blood;	PUB	OTH	Insulin, Medicor		diabetic, coronary artery disease;	~ ()~~~In patient		1						1	Chills; Sepsis; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0057181	11/08/1993	CA	62.0	62		F	11/01/1993	was not feeling well when took shot; (irritable bowel); started feeling achy & not feeling well; felt very cold; sl h/a, sore throat, congestion w/sl cough, post nasal drip; has constipation; soreness of arm;				Y					Y	10/22/1993	10/22/1993	0	NONE	PUB	PUB	Vitamins	poss irritable bowel	allergic to PCN, Iodine, & vitamin C;	~ ()~~~In patient		1						1	Chills; Constipation; Cough; Headache; Malaise; Myalgia; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4938148~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057183	11/08/1993	NV	53.0	53		F	10/21/1993	1st day inc diaphoresia, weakness 13OCT93 & chills & sore aching all over; 15OCT93 8AM tickling & burning in rt side of chest & tight (non-productive cough);				Y					N	10/02/1993	10/13/1993	11	18OCT93 CXR-fibrotic lungs-acute bronchitis & sinusitis;	PVT	PUB	Prozac, Prilosec, Pravachol, Premarin & Levinex;	sinusitis;	hyperacidity, depression, hyperlipidemia, interstitial cystitis;	pt exp rxn w/flu vax @ 40 yrs old;~ ()~~~In patient		1						1	Asthenia; Bronchitis; Chest pain; Chills; Cough; Hyperhidrosis; Myalgia; Pulmonary fibrosis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057188	11/08/1993	MA	37.0	37		F	10/25/1993	severe h/a, total body aches, congestion, coughing, runny nose, severe sweats, mild rash on face, sneezing (did not take temp); took over the counter products lasted 8 days;									N	10/06/1993	10/14/1993	8	congestion (nasal) still remains w/h/a;	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Cough; Headache; Hyperhidrosis; Myalgia; Rash; Rhinitis	FLUX~PFIZER\WYETH~4938083~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057189	11/08/1993	MA	31.0	31		F	11/01/1993	dizziness, nausea, vomiting sx lessened over 48 hrs; treated w/rest, pepto bismol, APAP;									Y	10/20/1993	10/23/1993	3		PUB	OTH				~ ()~~~In patient		1						1	Dizziness; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057193	11/08/1993	IL	46.0	46		F	11/02/1993	hives on abdo, neck resolved in 2-3 hrs; no treatment;									Y	10/27/1993	10/28/1993	1	NA	OTH	PVT	Tamoxifen, Bellergal	NA	hayfever, molds, grasses; breast cancer;	NA~ ()~~~In patient		1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~3F41123~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057195	11/08/1993	FL	74.0	74		M	10/14/1993	localized (4 inch) redness, induration & swelling-resolved on its own by the time pt @ MD office;									Y	10/12/1993	10/13/1993	1	NONE	PVT	PVT			tegretol-dizziness;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLUX~PFIZER\WYETH~4938138~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~344951~UNK~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0057199	11/09/1993	ME	52.0	52		F	10/27/1993	swelling in throat, inflammed mucus membranes (no trouble breathing); red, sore & swollen eyes;									N	10/26/1993	10/26/1993	0	NA	PVT	PVT	Hormones	NONE	NONE	NA~ ()~~~In patient	ME93049	1						1	Conjunctivitis; Eye pain; Face oedema; Laryngospasm; Mucous membrane disorder	FLU3~PARKE-DAVIS~01293P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057227	11/09/1993	MA	76.0	76		F	11/01/1993	2 days p/inject pt devel hives then diarrhea & nausea w/body aches; pos resp exaccerbation of COPD; pt hosp for SOB & grand mal sz; in ER:					Y	6			Y	10/12/1993	10/14/1993	2		OTH	PUB	Calcimar; Lasix, Cardizem, Ativan, K-cc; Atorvent; Prilosec-Ventolin; Beconnse;	NONE	allergy PCN; dx bronchial asthma-paget's dis; HTN-CAD-Angina-Diverticulitis;	~ ()~~~In patient		1						1	Condition aggravated; Convulsion; Diarrhoea; Dyspnoea; Grand mal convulsion; Myalgia; Nausea; Urticaria	FLUX~PFIZER\WYETH~4938084~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0057228	11/09/1993	AL	63.0	63		M	11/02/1993	Guillian barre synd;			Y	Y	Y	15	Y		U	10/06/1993	10/23/1993	17		PVT	PVT	Cold SR; Syazide	NONE	hypertension, alcoholism	NONE~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLUX~PFIZER\WYETH~4938085~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0057239	11/09/1993	CA	23.0	23		F	10/22/1993	c/o dizziness, lightheadedness-started day p/vax persisted x 4 hrs; also had knot inflammation & lt arm inject site; 23OCT93 sx are gone;				Y					Y	10/18/1993	10/19/1993	1	NONE	PVT	MIL	Buspar, Ortho-Novum 777;	denies any;	allergic erythromycin dx asthma 1989;	~ ()~~~In patient		1						1	Dizziness; Injection site inflammation; Injection site mass	FLUX~PFIZER\WYETH~4938155~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057240	11/09/1993	TX	29.0	29		F	10/29/1993	pt recvd vax 15OCT 230PM; 530PM pt noted chest pain, SOB, coughing; 730PM nausea, chills, vomiting, t103;				Y					Y	10/15/1993	10/15/1993	0	NONE	OTH	UNK	on 777	NONE	NONE	NONE~ ()~~~In patient		1						1	Chest pain; Chills; Cough; Dyspnoea; Nausea; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~3F41010~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0057242	11/09/1993	PA	1.3	1	.3	F	11/04/1993	hives all over body x 3 days; rx DPh x 3 days;				Y					Y	10/21/1993	10/21/1993	0	NONE	PVT	PVT	Bactrim	URI	down syndrome	NONE~ ()~~~In patient		1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~3F41123~3~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0057245	11/09/1993	CA	46.0	46		F	11/03/1993	30OCT93 pt c/o temp 99-100, myalgias, cough non productive; 1NOV93 pt c/o emesis x 2 days; seen by MD c/o congestion, productive cough, diarrhea, bed riden x 5 days;				Y					U	10/26/1993	10/30/1993	4	NONE	PVT	PVT		NONE	hypertonia, perimenopause, hyperlipidemia;	pt exp rxn @ 45 y/o w/FLuzone #1 dose;~ ()~~~In patient		1						1	Cough; Diarrhoea; Myalgia; Pyrexia; Rhinitis; Vomiting	FLU3~CONNAUGHT LABORATORIES~3F41125~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0057246	11/09/1993	WI	42.0	42		F	11/04/1993	woke up 3NOV93 in AM w/eye itching swelling around eyes w/mild reddness, SOB, mild rash;				Y					Y	11/02/1993	11/03/1993	1		PUB	UNK	Inhalers for asthma;	NONE	asthma	~ ()~~~In patient		1						1	Dyspnoea; Face oedema; Pruritus; Rash; Vasodilatation	FLUX~PFIZER\WYETH~4938147~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057249	11/09/1993	MA	48.0	48		F	11/02/1993	5 days p/inject, sore throat, fever muscle joint pain, fatigue, congestion, pain in trachea (bronchitis);				Y					U	10/18/1993	10/23/1993	5	PCXR, sinus filsm;	MIL	UNK	Synthroid	NONE	hypothyroidism	~ ()~~~In patient		1						1	Arthralgia; Asthenia; Bronchitis; Myalgia; Pharyngitis; Pneumonia; Pyrexia; Sinusitis	FLUX~PFIZER\WYETH~4938083~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057253	11/09/1993	MA	69.0	68		F	11/05/1993	21OCT93 extreme fatigue leftside of neck swollen; 23OCT93 same sx plus lt ear blocked; 26OCT93 sx subside; 29OCT93 pt reocvered;									Y	10/03/1993	10/21/1993	18		PUB	UNK				~ ()~~~In patient	MA9362	1						1	Asthenia; Ear disorder; Oedema	FLUX~PFIZER\WYETH~4938083~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057254	11/09/1993	MA	38.0	38		F	10/19/1993	2 days p/vax 16OCT93 pt started to feel achey; 3 days p/vax 17OCT93 body aches, fever (didn't measure); 4 days p/vax 18OCT nausea, fainted x 2; 5 days p/vax 19OCT queasy;									Y	10/14/1993	10/16/1993	2		PUB	PUB	NONE	cold sx, no fever	NONE	~ ()~~~In patient	MA9363	1						1	Myalgia; Nausea; Pyrexia; Syncope	FLUX~PFIZER\WYETH~4938083~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057255	11/09/1993	CA	49.0	49		F	10/22/1993	c/o feeling flushed started 19OCT93 1500 lasted & 3 hrs woke up @ MN 19OCT w/bad h/a; hx cchronic h/a; 22OCT still has h/a, malaise;									N	10/18/1993	10/19/1993	1	NONE	PVT	PVT	Premavia, Provera;	denies any illness	stress related HTN, hypercholesteremia, Chronic h/a's	~ ()~~~In patient		1						1	Condition aggravated; Malaise; Vasodilatation	FLUX~PFIZER\WYETH~4938155~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057259	11/09/1993	MA	64.0	64		F	11/05/1993	fainted twice w/in 5 mins; 7AM; 15OCT93; felt dizzy til noon;									Y	10/13/1993	10/15/1993	2		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Dizziness; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057262	11/09/1993	MI	69.0	69		M	11/02/1993	swelling of hands, arms paresthesias of lt arm; grip strength diminished sujective;									U	10/19/1993	11/02/1993	14	sed rate, ANA, RF ordered;	PVT	PVT	Auestran, Capoten, Tenex, Hydrochlorthiazide;	NONE	sulfa; (denies egg or chicken allergy);	pt exp rxn 19OCT93 @ 68 y/o w/fluzone;~ ()~~~In patient		1						1	Myasthenic syndrome; Oedema peripheral; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~3F41029~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057263	11/09/1993	VA	44.0	44		F	11/01/1993	large red skin react 6cm x 6cm; sl raised; hot & very sore to touch w/dark bruising; noted several days p/inject; no fever noted;									Y	10/15/1993	10/16/1993	1		OTH	PVT	NA	NA	NA	~ ()~~~In patient		1						1	Ecchymosis; Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLUX~PFIZER\WYETH~4938185~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057265	11/09/1993	ND	43.0	43		F	11/03/1993	21OCT93 @ 230PM pt was given flu shot; pt states noticed sniffles & cold like sx; @ approx 930PM 21OCT93; these sx were not present the following day; w/in 24 hrs of vax noticed lymphnode swelling; ext tender; devel v,d & chills;									Y	10/21/1993	10/21/1993	0	NONE	PVT	OTH	NONE	NONE	no known allergies, no medical condition;	NONE~ ()~~~In patient		1						1	Chills; Diarrhoea; Lymphadenopathy; Pain; Pharyngitis; Rhinitis; Vomiting	FLUX~PFIZER\WYETH~4938091~2~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057266	11/09/1993	CA	40.0	40		F	11/01/1993	pt recvd vax had h/a, diarrhea, felt out of sorts; next AM felt sore esp upper back, arms, neck; felt tired; went to work; had runny nose, sore throat, myalgias; t37.9; chills;									Y	10/27/1993	10/27/1993	0	sinus infect in prior 4 wks; Amoxicillin then Floin; had yellow/green sinus drainage;	PVT	PVT	NONE	s/p sinus infect immed prior	sinusitis was just reated;	pt exp rxn w/flu shot;~ ()~~~In patient		1						1	Asthenia; Back pain; Diarrhoea; Headache; Myalgia; Neck pain; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41172~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057267	11/09/1993	WI	40.0	40		F		4 hrs p/vax pt became ill w/gen'l aches, sore throat, congestion; nodes tender & swollen 2-3 hrs;									Y	10/22/1993	10/22/1993	0	NONE	PUB	PVT	NONE	NONE	NKA	~ ()~~~In patient		1						1	Lymphadenopathy; Malaise; Myalgia; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4938121~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057269	11/09/1993	TX	51.0	50		F	11/03/1993	dizziness-elevated blood pressure, hyperventelated-throat burning;									Y	11/03/1993	11/03/1993	0	NA	OTH	OTH	Ogen	NONE	NONE	NONE~ ()~~~In patient		1						1	Dizziness; Hypertension; Hyperventilation; Pharyngitis	FLUX~PFIZER\WYETH~4938262~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057270	11/10/1993	PA	70.0	70		M	10/28/1993	pt recvd flu vax on 6OCT93 & 6 days later was adm to the hosp w/dx pancytopenia; had no prior hx of hemotologic abnormalities;					Y	10			U	10/05/1993	10/18/1993	13		OTH	OTH	NONE	unk	pt has diabetes, end stage renal failure & is on kidney dialysis;	~ ()~~~In patient	893302001J	1						1	Anaemia; Asthenia; Hepatic cirrhosis; Hepatocellular damage; Hepatosplenomegaly; Leukopenia; Pancytopenia; Thrombocytopenia	FLUX~PFIZER\WYETH~4938152~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0057271	11/10/1993	CT	11.0	11		F	11/05/1993	SOB, wheezing, chest pain;				Y					Y	11/04/1993	11/04/1993	0		PUB	UNK		NONE	NONE	~ ()~~~In patient	CT9309	1						1	Asthma; Chest pain; Dyspnoea	FLU3~CONNAUGHT LABORATORIES~3F41032~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0537W~UNK~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0057278	11/10/1993	OR	79.0	79		M	10/21/1993	onset 12OCT93 ached all over & felt terrible denies fever & other sx; seen by MD 13OCT; states still feeling poorly;				Y					N	10/11/1993	10/12/1993	1		PUB	PVT	Talwin, Prednisone, Theodur, Quinidine, Spironolactane;	NONE	emphysema asthma, hypertension	NONE~ ()~~~In patient		1						1	Malaise; Myalgia	FLUX~PFIZER\WYETH~4938140~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057280	11/10/1993	OR	72.0	72		F	10/21/1993	h/a for several, nausea, probable fever (very thristy) denies feel awful like getting flu;									Y	10/07/1993	10/07/1993	0	NONE	PUB	PVT	Premarin	NONE	NKA	pt was sick @ 7 y/o w/flu vax #1;~ ()~~~In patient		1						1	Headache; Influenza; Malaise; Nausea; Pyrexia; Thirst	FLUX~PFIZER\WYETH~4938140~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057281	11/10/1993	IN	23.0	23		F	11/03/1993	29OCT(3 pt c/o redness & tenderness of inject site lt deltoid; on exam redness & induration seen @ inject site; 25mm x 25mm area warm & tender when touched;									Y	10/27/1993	10/28/1993	1	NONE	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4938168~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057283	11/10/1993	VA	54.0	54		U		bodyache, chills, upset stomach, h/a started on 17OCT & lasted x 5 days; pt was unable to work									Y	10/15/1993	10/17/1993	2	NONE	OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Chills; Dyspepsia; Headache; Myalgia	FLU3~CONNAUGHT LABORATORIES~3F41008~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057284	11/12/1993	TX	84.0			F	10/28/1993	Pt recvd vax & suffered a stroke; reporter has only seen pt once; reporter has no past medical records for this pt, therefore, no further info is available;								Y	U					OTH	OTH	UNK	unk		~ ()~~~In patient	893302002J	1						1	Cerebrovascular accident	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0057289	11/12/1993	CA	70.0	70		M	10/21/1993	c/o chest congestion w/o fever given Amoxicillin & Amadine for dx viral synd & poss sinusitis;				Y					Y	10/07/1993	10/11/1993	4	NONE	PUB	PUB		denied	immune compromised-further testing to go;	~ ()~~~In patient	CA93093	1						1	Infection; Lung disorder; Sinusitis	FLUX~PFIZER\WYETH~4938146~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057290	11/12/1993	CA	67.0	67		F	10/25/1993	pt recvd vax 15OCT93 & exp h/a, lt arm pain, AM lt eye tearing got worse-progressed to where face felt like a xylocaine shot; dx bells palsey;				Y					U	10/15/1993	10/17/1993	2		PUB	PUB	premarin, Oretic, AZCT;	NONE	NONE	~ ()~~~In patient	CA93094	1						1	Facial palsy; Headache; Lacrimal disorder; Pain; Paraesthesia	FLUX~PFIZER\WYETH~4938146~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057297	11/12/1993	CA	66.0	66		M	10/18/1993	pt recvd flu vax 1230PM rash over entire body commencing @ 4Pm puritus, reddish rash, cont; MD exam 15OCT93;				Y					Y	10/13/1993	10/13/1993	0	PE	PUB	PUB	NONE	NONE	PCN inject;	NONE~ ()~~~In patient	CA93101	1						1	Pruritus; Rash	FLUX~PFIZER\WYETH~4938148~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057301	11/12/1993	CA	68.0	68		M	10/26/1993	lt deltoid area & down to elbow & under arm to elbow is red, swollen & extremely warm starting on 19OCT93; pt went to MD & was told had an infect;				Y					Y	10/18/1993	10/19/1993	1	NONE	PUB	PUB		NONE	NONE	NONE~ ()~~~In patient	CA93105	1						1	Infection; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLUX~PFIZER\WYETH~4938148~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~358958~1~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0057306	11/12/1993	ME	6.0	6		F	11/08/1993	pt dizzy, lethargic, difficulty in waking up, twitching, cold sweats, hives on arms;				Y					Y	11/05/1993	11/05/1993	0	NA	PUB	PUB	Pedi-rynatin, Theopholin, slo bid;	maybe?	asthmatic	NONE~ ()~~~In patient	ME93050	1						1	Dizziness; Hyperhidrosis; Muscle twitching; Somnolence; Urticaria	FLUX~PFIZER\WYETH~4938217~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057307	11/12/1993	ME	56.0	56		F	10/27/1993	4-5 days p/shot h/a, stomachache, swollen knees, hives, t101; ?brown spider virus;				Y					N	10/15/1993	10/22/1993	7	NA	PVT	PVT	NONE	NONE	NONE	NA~ ()~~~In patient	ME93051	1						1	Abdominal pain; Headache; Infection; Osteoarthritis; Pyrexia; Urticaria	FLU3~CONNAUGHT LABORATORIES~3F41016~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0057318	11/12/1993	OH	62.0	62		F	10/22/1993	rash, hives devel during the noc; called clinic 22OCT93; pt instructed to call MD immed; seen by MD 22OCT93;				Y					Y	10/21/1993	10/21/1993	0		PUB	PUB	NONE	NONE	sulfa	~ ()~~~In patient	OH93087	1						1	Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~3F41009~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0057319	11/12/1993	OH	70.0	70		F		began itching @ site 1 1/2 hrs post vax; on observation site was warm to touch, & indurated by 2 in & red @ border;										10/29/1993	10/29/1993	0		PUB	PUB				~ ()~~~In patient	OH93089	1						1	Injection site hypersensitivity; Injection site mass; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~3F41009~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~340940~UNK~SC L~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0057322	11/12/1993	SC	0.7	0	.7	M	10/13/1993	pt had a sequestration crisis p/vax; pt devel a t101, HBF 65 & had to be hospitalized for treatement;					Y					10/29/1992	10/29/1992	0		UNK	UNK	NA		PCN	flu vax 1992-1993;~ ()~~~In patient		1						1	Condition aggravated; Laboratory test abnormal; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0057323	11/12/1993	MI	82.0	81		M	10/29/1993	rapid progressive dementia ventilation for respiratory failure, t105; family states confusion started about 16 hrs p/vax; post flu vax encephalitis;	Y				Y					09/13/1993	09/14/1993	1	WBC 2.3; nl 4-11; sed rate 36; Ptt 5; CSF WNL; Bl no grwoth; titer for EEE, california E, st louis E pending; Enterovirus & Herpes cultures being done on CSF;;	UNK	UNK			remains hospitalized on ventilator; outcome remains guarded;	~ ()~~~In patient		1						1	Apnoea; Blood thromboplastin decreased; Confusional state; Dementia; Encephalitis; Leukopenia; Pyrexia; Red blood cell sedimentation rate increased	FLUX~PFIZER\WYETH~493814~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0057324	11/12/1993	MI	78.0	77		M		17SEP93 adm to hosp w/acute deliruim placed on ventilator 18SEP93 for acute resp failure; unresponsive; dx of past immun encephalitis; recvd flu vax 13SEP93; reported confusion;					Y					09/13/1993	09/17/1993	4	MRI abn inc in T2 signal; blood cultures-no growth; blood chemistry portein 5.3; albumin 2.8; WBC 15.2; sed rate ESR 28mm;	UNK	UNK				~ ()~~~In patient		1						1	Apnoea; Confusional state; Delirium; Encephalitis; Hypoproteinaemia; Leukocytosis; Red blood cell sedimentation rate increased; Stupor	FLUX~PFIZER\WYETH~493814~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0057327	11/12/1993	MI	39.0	38		F	11/04/1993	on evening of 21OCT93 noted redness @ inject site & sore arm; upon awakening 22OCT93 found red raised itchy rash over body-worse in creases;				Y					Y	10/21/1993	10/22/1993	1	NONE	OTH	PVT	NONE	NONE	NKA	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Myalgia; Pruritus; Rash maculo-papular	FLU3~PARKE-DAVIS~00963P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0057329	11/12/1993	OR	74.0	74		F	11/02/1993	nausea, anorexia, elevated liver function test; neg Hep A, B, C panel; nl LFT w/in same day but also tx ATB; Ceftin; x 4 days UTI;				Y					Y	10/01/1993	10/03/1993	2	11OCT93 LDH 435; SGOT 260; SGPT 387; 15OCT93 GGT 80; LDH 356; SGOT 168; SGPT 396; neg HEp A, B, C	PVT	PVT	Capotel, Ortho, Lasix, COumadin, Vitamins, Micro K, Proventil, Vanceril inhalers;	UTI	CVA, CHF, Diabetes;	~ ()~~~In patient		1						1	Alanine aminotransferase increased; Anorexia; Aspartate aminotransferase increased; Blood lactate dehydrogenase increased; Gamma-glutamyltransferase increased; Hepatic function abnormal; Nausea	FLUX~PFIZER\WYETH~938156~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057331	11/12/1993	CA	15.0	15		F	10/28/1993	minimal swelling @ site of inject; numbness & swelling of hands;										10/18/1993	10/18/1993	0		PVT	PVT				~ ()~~~In patient		1						1	Injection site oedema; Oedema peripheral; Paraesthesia	FLUX~PFIZER\WYETH~4938148~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~LEDERLE LABORATORIES~356907~6~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0057030	11/15/1993	UT	31.0	31		F	11/01/1993	3 days p/flu vax pt exp rt leg weakness & numbness; pt hospitalized;				Y	Y				N	10/18/1993	10/21/1993	3		PVT	PVT	NONE	URi	NONE	~ ()~~~In patient		1						2	Myasthenic syndrome; Paraesthesia; Myasthenic syndrome; Paraesthesia	FLUX~PFIZER\WYETH~4938137~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938137~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0057341	11/15/1993	MA	59.0	59		M	11/12/1993	guillain barre syndrome			Y	Y	Y	8	Y			10/25/1993	11/02/1993	8		OTH	PUB		unk	unknown	~ ()~~~In patient	MA9355	1						1	Guillain-Barre syndrome; Coordination abnormal; Guillain-Barre syndrome; Hyporeflexia; Myasthenic syndrome; Neuropathy; Paraesthesia; Paralysis; Paralysis flaccid	FLUX~PFIZER\WYETH~4938151~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation	Influenza
0057353	11/15/1993	CA	78.0	78		M	11/08/1993	acute transverse myelitis is reported in a pt who recvd flu vax around 22OCT93; OCT93 exp pain in the back & numbness in rt leg; 26OCT93 devel paralysis in both legs; pt did not have any control over bladder or bowel movements;					Y			Y	N	10/22/1993	10/25/1993	3	spinal aspiration showed elevations of proteins;	OTH	OTH	APAP, Vitamins;	N?S	arthritis	NS~ ()~~~In patient	27481	1						1	Back pain; CSF test abnormal; Faecal incontinence; Myelitis; Paraesthesia; Paralysis; Urinary incontinence	FLU3~PARKE-DAVIS~00763P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation,Disabling	Influenza
0057376	11/15/1993	HI	39.0	39		F	10/22/1993	pain, swelling & inc warmth @ inject site; also hives around inject site;									Y	10/22/1993	10/22/1993	0		PUB	PUB		NONE	NONE	~ ()~~~In patient	HI9310	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41001~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057378	11/15/1993	IL	38.0	38		F	10/11/1993	20-30 mins p/vax rt arm @ the inject site became swollen & warm to touch; ice pack was applied PRN the rest of the day; also had numbness & tingling of rt arm & hand;				Y					Y	10/08/1993	10/08/1993	0	NONE	PUB	PUB	steroid inhalers	NONE	chronic sinus infections freq ATB;	~ ()~~~In patient	IL93116	1						1	Injection site oedema; Paraesthesia; Rash maculo-papular; Vasodilatation	FLU3~PARKE-DAVIS~0863P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0057381	11/15/1993	MA	76.0	76		F	11/01/1993	1 day p/vax, blurring of vision, bilateral about 4-5 days p/had a burning sensation over entire body red area @ site; no fever;				Y					Y	10/20/1993	10/21/1993	1	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MA9351	1						1	Amblyopia; Injection site hypersensitivity; Pain	FLUX~PFIZER\WYETH~4938083~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057382	11/15/1993	MA	59.0	59		F	10/28/1993	inject site hot & red, itchy; extensive area involving most of upper arm from elbow to the shoulder; seen by MD & dx w/cellulitis;				Y					Y	10/14/1993	10/16/1993	2	NONE	PUB	PUB	Zestril, Naprosyn, ASA, Seldane;		diabetes, hypertension;	NONE~ ()~~~In patient	MA9352	1						1	Cellulitis; Injection site hypersensitivity; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~4938083~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057383	11/15/1993	MA	66.0	66		F	11/01/1993	soreness @ inject site initially w/in 24 hrs devel numbness down rt arm to the thumb; some edema of thumb & wrist; fingers sore some weakness; unable to open a jar; some discoloration of the fingers for a few days; itchy rash on face;									U	10/18/1993	10/19/1993	1	NONE	PUB	PUB	Vasotec, synthroid	NONE	hypertension & hypothyroid	NONE~ ()~~~In patient	MA9353	1						1	Injection site pain; Myalgia; Myasthenic syndrome; Oedema peripheral; Osteoarthritis; Paraesthesia; Pruritus; Skin discolouration	FLUX~PFIZER\WYETH~4938083~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057384	11/15/1993	MA	65.0	65		F	11/05/1993	running eyes & nose, sinuses infect, tightness in chest, wheezing diarrhea, change in voice;									Y	10/27/1993	10/30/1993	3	NONE	OTH	PUB		sinus infect, brochiectisis	brochiectisis, fibromyalgia;	~ ()~~~In patient	MA9354	1						1	Asthma; Chest pain; Diarrhoea; Dysphonia; Lacrimal disorder; Rhinitis; Chills; Cough; Myalgia; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~4938083~2~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0057385	11/15/1993	MA	48.0	48		F	11/05/1993	830AM vax administered; 11AM exp burning eyes, redness both eyes, dizziness, salty throat, itchiness-diarrhea; DPH;									Y	10/27/1993	10/27/1993	0	NA	OTH	OTH		NONE	NONE	NA~ ()~~~In patient	MA9356	1						1	Conjunctivitis; Diarrhoea; Dizziness; Dysgeusia; Eye pain; Pruritus	FLU3~PARKE-DAVIS~00673P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057386	11/15/1993	MA	49.0	49		F	11/09/1993	5PM lightheadness & dizziness, h/a, vomiting; 8PM localized area size of orange, red, hot, sore, now bruised;									Y	11/02/1993	11/02/1993	0	NONE	PUB	PUB		NONE	acidic foods, migrane h/a;	~ ()~~~In patient	MA9357	1						1	Dizziness; Ecchymosis; Headache; Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation; Vomiting	FLUX~PFIZER\WYETH~4938083~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057387	11/15/1993	MS	73.0	73		F	11/08/1993	25OCT93 felt sick when got up 5AM; went to restroom & everything went black; had Bm & broke out in a cold clammy sweat; was ashey & BP dropped 100/60 had achy feeling of shoulders, stayed cold; MD thought had rectal bleeding;					Y	4			Y	10/20/1993	10/25/1993	5	HGB dropped 3 pints from CBC, CXR, KUB & EKG AM to 430PM; hwite count dropped during hosp stay; BP upon d/c from hosp 100/80;	PUB	PUB	Tenormin, Lanoxin, Cardizen, Humibid LA, synthroid;	NONE	heart condition, previous rectal bleeding, blackouts; allergic to procardia; darvon, ASA, vancomycin & chocolate;	NA~ ()~~~In patient	MS93042	1						1	Chills; Condition aggravated; Hyperhidrosis; Hypotension; Malaise; Myalgia; Pallor; Syncope	FLUX~PFIZER\WYETH~4938162~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0057402	11/15/1993	MD	65.0	65		F	10/29/1993	pt recvd flu vax 8PM 28OCT93; went to bed 11PM woke @ MN & states felt like throat was closing up; voice became hoarse, heart rate up; called 911, taken to hosp & adm;				Y	Y	1			Y	10/28/1993	10/29/1993	1		PUB	PUB	NONE	recoverning from URI from 6OCT93	NONE	~ ()~~~In patient		1						1	Dysphonia; Laryngospasm; Tachycardia	FLU3~PARKE-DAVIS~00963P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0057409	11/15/1993	OH	55.0	55		F	11/08/1993	MD saw pt on 28OCT93 & dx bacterial bronchitis, sinus infect & kidney infection which pt believes are the result of the flu vax; pt has had systemic lupus for over 25 hrs w/chronic systemic fungus infect;				Y					Y	10/22/1993	10/28/1993	6		PUB	PUB	Plaquenil, Prednisone;	NONE	systemic lupus w/ chronic systemic fungus infect;	~ ()~~~In patient		1						1	Bronchitis; Infection; Sinusitis; Urinary tract infection	FLU3~CONNAUGHT LABORATORIES~3F41009~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0057412	11/15/1993	MA	30.0	30		F	11/08/1993	began w/hives (general) including face & chest; woke up 430AM w/chest pains & dyspnea; dx acute allergy w/esophageal swelling;				Y					Y	11/02/1993	11/03/1993	1	CXR;	OTH	PUB	BCP	NONE	NKA	~ ()~~~In patient		1						1	Chest pain; Dyspnoea; Hypersensitivity; Oesophagitis; Urticaria	FLUX~PFIZER\WYETH~4938083~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057413	11/15/1993	MD	55.0	55		F	11/08/1993	21OCT pt recvd vax & 23OCT congestion started; 25OCT n&v severe required 2 liters of IV fluid in the ER; vomiting has resolved; severe h/a requiring medication w/codeine; 8NOV still extremely fatigued;				Y						10/21/1993	10/23/1993	2	NONE	UNK	PVT	Estraderm patch; Prinivil; Lozol;		ren-ery-sulfa;	~ ()~~~In patient		1						1	Asthenia; Headache; Nausea; Rhinitis; Vomiting	FLUX~PFIZER\WYETH~4938091~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057415	11/15/1993	WA	45.0	45		F	11/01/1993	15 mins following vax pt exp SOB, rapid heart rate, hives on chest & back, mouth tingling;				Y					U	10/30/1993	10/30/1993	0		PVT	PVT	NONE	NONE	nuts, tomato, choclate, coffee-multiple foods (not eggs);	~ ()~~~In patient		1						1	Dyspnoea; Paraesthesia; Tachycardia; Urticaria	FLU3~CONNAUGHT LABORATORIES~3F41034~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0057416	11/15/1993	TX	69.0	69		F		gen'l erythematous & papular pruritic skin eruption;				Y					U	10/29/1993	10/30/1993	1		PVT	PVT	Tenormin, Zestril, Premarin;	NONE	PCN	~ ()~~~In patient		1						1	Pruritus; Rash; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~3F41016~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0057418	11/15/1993	CA	35.0	35		F	11/08/1993	pt recvd vax t100, h/a, nausea, gas, loose stool, h/a severe, difficult to focus; seen @ ER poss meningitis w/ c/o stiff neck; feels unwell;				Y					U	11/01/1993	11/02/1993	1	declined spinal tap;	PVT	OTH	NONE	NONE	asthma;	NONE~ ()~~~In patient		1						1	Diarrhoea; Flatulence; Headache; Malaise; Meningitis; Nuchal rigidity; Pyrexia; Visual disturbance	FLUX~PFIZER\WYETH~4938188~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057419	11/15/1993	IL	50.0	50		M	11/11/1993	devel h//a day p/flu shot felt weak & nauseous & lightheaded; residual tiredness;				Y					Y	11/02/1993	11/03/1993	1	EKG-sinus bradycardia;	OTH	PUB	Inderal Norces	NONE	Migraine, HT	~ ()~~~In patient		1						1	Asthenia; Bradycardia; Dizziness; Headache; Nausea	FLU3~CONNAUGHT LABORATORIES~3F41010~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0057426	11/15/1993	CA	65.0	65		F	11/08/1993	devel redness & swelling @ site of inject rt deltoid; seen @ MD 15OCT93; upper rt arm swollen red;									Y	10/11/1993	10/11/1993	0		PVT	PVT	Zesteril, Premarin, THeodur, Procanomide;	NONE	septra, Quinidine Codiene	pt exp rxn w/Td vax;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~3F41033~5~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~3G51153~1~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0057427	11/15/1993	MI	57.0	57		F	11/05/1993	fever, site swollen hard & nausea;									U	11/02/1993	11/02/1993	0		PVT	PVT	premarin, Proventil, Capoten			~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Nausea; Pyrexia	FLUX~PFIZER\WYETH~493147~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1042V~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0057428	11/15/1993	MA	47.0	47		F	11/02/1993	fever, body aches, fatigue;									U	10/27/1993	10/29/1993	2		PVT	PVT	Synthroid	NONE	Hypothyroidism	~ ()~~~In patient		1						1	Asthenia; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41032~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057433	11/15/1993	LA	38.0	38		F	10/07/1993	lg red area around inject site (approx 2.5x6 cm); hot to touch; painful to touch;									U	10/05/1993	10/06/1993	1	NA	PVT	OTH	NA	NA	NA	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLUX~PFIZER\WYETH~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057434	11/15/1993	ND	56.0	56		F	11/08/1993	pt states that arm swelled for couple days immed p/receiving flu vax; the following wk pt exp itchy & puffy eyes on 5NOV93 exp rash around neck area;										10/21/1993	10/24/1993	3	NONE	PVT	PVT	Lanoxin, Synthroid;	NONE	Demerol, Cortisone, Strawberries, goose; multiple allergies;	~ ()~~~In patient		1						1	Face oedema; Oedema peripheral; Pruritus; Rash	FLUX~PFIZER\WYETH~4938091~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057436	11/15/1993	MA	46.0	46		F	11/08/1993	pt had low grade fever, stiff neck, diarrhea for about 12 hrs; pt had cold sx also;									Y	10/27/1993	10/27/1993	0		PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Diarrhoea; Nuchal rigidity; Pharyngitis; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~3F41027~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057437	11/15/1993	TX	68.0	68		F	11/04/1993	pt recvd pruritic skin react; rx DPH;									U	10/28/1993	10/29/1993	1		PVT	PVT	Zantac & Atrivan;	NONE	NONE	~ ()~~~In patient		1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~3F41016~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057438	11/15/1993	NH	44.0	44		F	11/12/1993	approx 24 hrs p/vax pt exp sl achiness & warmth 48 hrs later  had t102-104, myalgias, arthralgias, h/a; lasted 4-5 days according to client;									Y	10/28/1993	10/29/1993	1	NONE	OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Arthralgia; Headache; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41027~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057441	11/15/1993	MO	39.0	39		F		site became red, hot, swollen, itchy; DPH given & 2 days later given steroid cream;									Y	11/04/1993	11/04/1993	0		PUB	PVT		NONE	NONE	hypertension~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41032~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057442	11/15/1993	MN	57.0	57		F	11/10/1993	devel significant stiffness in neck & hips; particularly noted upon awakening &  moving about in the morning;										10/20/1993	10/21/1993	1		PVT	PVT	Estorgen replacement, vitamin;	NONE	NONE	~ ()~~~In patient		1						1	Arthropathy; Nuchal rigidity	FLUX~PFIZER\WYETH~4938153~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057443	11/15/1993	MA	3.0	3		M	11/10/1993	24 hrs p/vax pt devel hives;									Y	11/02/1993	11/03/1993	1		PVT	PVT	Ventolin;		asthma	~ ()~~~In patient		1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~3F41032~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057444	11/15/1993	MI	50.0	50		F	11/12/1993	aches, pains, diarrhea, & fever beginning 3 hrs p/vax; 12 hrs subsided & felt fine next day;									Y	10/29/1993	10/29/1993	0	NONE	PVT	PVT	Intal, Vanceril, Theophylline	NONE	fish, mold, dust, grass allergies;	NONE~ ()~~~In patient		1						1	Diarrhoea; Myalgia; Pain; Pyrexia	FLUX~PFIZER\WYETH~4938193~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057384	11/17/1993	MA	63.0	63		F	11/13/1993	fever, chills, achy feeling & cough due to post nasal drip; From 3OCT93 to 9NOV93; Bactrim;				Y					Y	10/27/1993	10/30/1993	3		PUB	PUB	Vasotec, Mevacor, Diabeta;		molds, dust, trees, grasses, PCN; hypertension diabetes, high cholestrol;	~ ()~~~In patient	MA9366	1						2	Asthma; Chest pain; Diarrhoea; Dysphonia; Lacrimal disorder; Rhinitis; Chills; Cough; Myalgia; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~4938083~2~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0057461	11/17/1993	OH	39.0	39		F	11/01/1993	t100, diarrhea, shakes, pain & joint aches, 1 day abdominal cramps;									Y	10/25/1993	10/30/1993	5		PVT	PVT	Biaxin (ATB);			~ ()~~~In patient	OH93088	1						1	Abdominal pain; Arthralgia; Diarrhoea; Pain; Pyrexia; Tremor	FLU3~CONNAUGHT LABORATORIES~3F41171~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~362967~UNK~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0057462	11/17/1993	OH	54.0	54		F	10/11/1993	eyes burning/watery noticeable to others; nose runny, coughing, hoarseness; sudden onset; felt as if throat was closing; later felt feverish, had chills; temp not taken; tongue swelled, lips-tongue sore;									N	10/08/1993	10/08/1993	0		PUB	PUB	Estrace, Provera;	NONE	NONE	~ ()~~~In patient	OH93091	1						1	Dysphonia; Face oedema; Glossitis; Lacrimal disorder; Laryngospasm; Pyrexia; Rhinitis; Tongue oedema	FLU3~CONNAUGHT LABORATORIES~3F41142~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057464	11/17/1993	MI	39.0	39		F	11/03/1993	pt recvd flu vax in rt arm & exp inc pain in arm as day went on; 29OCT93 very sl rash & t100.8; 30OCT93 inc rash & arm swelling t99.8; 31OCT93 temp normal total body rash hot & itchy;								Y		10/28/1993	10/28/1993	0		UNK	UNK	NA		NKA	~ ()~~~In patient		1						1	Oedema peripheral; Pain; Pruritus; Pyrexia; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4938121~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|PPV~MERCK & CO. INC.~358957~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0057465	11/17/1993	MI	43.0	43		M	11/03/1993	pneumovax & flu vax given & immed burning pain-progressing to significant swelling x 3 nl size burning pain severe erythema pain from upper arm; adenopathy pain & streaking w/swelling to elbow-ax out chest wall; still some prob today;								Y		10/28/1993	10/28/1993	0	NONE	UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Skin striae; Cough; Headache; Hypertonia; Lymphadenopathy; Malaise; Pain; Pyrexia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~4938121~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~358957~UNK~~~PNEUMO (PNU-IMUNE)~1|PPV~PFIZER\WYETH~358957~2~IM~RA~PNEUMO (PNU-IMUNE)~2	USA	Disabling	Influenza
0057465	11/17/1993	MI	44.0			M	11/13/1993	Pt recvd vax & 5-7 days of heat, redness, intense pain, stiffness, lymphadenitis in ax; pain radiated from deltoid down to elbow; general malaise & low grade temp followed along w/h/a & cough;;								Y		10/28/1993	10/28/1993	0	NA	UNK	UNK	NA			~ ()~~~In patient		1						2	Injection site hypersensitivity; Injection site oedema; Injection site pain; Skin striae; Cough; Headache; Hypertonia; Lymphadenopathy; Malaise; Pain; Pyrexia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~4938121~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~358957~UNK~~~PNEUMO (PNU-IMUNE)~1|PPV~PFIZER\WYETH~358957~2~IM~RA~PNEUMO (PNU-IMUNE)~2	USA	Disabling	Influenza
0057470	11/17/1993	FL	74.0	74		M	11/10/1993	poss transverse myelitis w/paralysis from chest down;	Y		Y		Y	25	Y	Y	N	10/01/1993	10/17/1993	16	extensive-none convlusive;	PVT	PVT		lung fibrosis/COPD	lung fibrosis/COPD	~ ()~~~In patient		1						1	Myelitis; Paralysis	FLU3~PARKE-DAVIS~00963P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0057476	11/17/1993	NM	31.0			F	11/11/1993	rash on both distal forearms rt elbow & upper abdo; raised red cluster of macules approx dime sized; severe itching;									Y	10/14/1993	10/16/1993	2	NONE	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Pruritus; Rash; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~3F41172~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057477	11/17/1993	NM	57.0	57		F	11/11/1993	transient large macular rash scattered throughout a field of fine macular rash w/extreme itching-lasted about 2 hrs then disappeared to appear somewhere else; lasted approx 2 wks; 1st appeared on face about 2 hrs p/inject;									Y	10/15/1993	10/15/1993	0		MIL	UNK	Lasix, Mirco-K	NONE	caine anesthetics, IVP dye, ASA, PCN-cream cheese; mitral insuff w/regurgitation/arthritis;	~ ()~~~In patient		1						1	Pruritus; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~3F41172~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057478	11/17/1993	MA	35.0	34		F	11/12/1993	s/s started 9NOV93 sore throat, body aches, low grade temp, h/a & chills; no hospitalization;									Y	10/27/1993	11/09/1993	13		PUB	UNK		NONE	NONE	~ ()~~~In patient		1						1	Chills; Headache; Myalgia; Pharyngitis; Pyrexia	FLUX~PFIZER\WYETH~4938083~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057479	11/17/1993	MA	38.0	38		F	11/15/1993	became ill 3-4 hrs p/flu shot; was still quite ill for 1 day following; began menstruating that day which was 8 days early in cycle; bled heavily for 1 wk; (pt states cycle is always regular & usually bleed for only 3 days);									U	10/19/1993	10/19/1993	0		OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Malaise; Menorrhagia; Menstrual disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057334	11/18/1993	FL	71.0	71		F	11/18/1993	admit 29SEP93 muscle weakness, trouble walking, nausea, no hx of prior neurolgic problems, DX GBS. (CSF 191mg/% protein). Pt had to be intubated and ventilated;			Y	Y	Y	27	Y		Y	09/23/1993	09/25/1993	2	6OCT93 CSF: glucose 92, protein 191, WBC 0, RBC 0	PVT	UNK	buspar, karax, voltarem	unk	DPH, cortisone, PCN, vancomycin	~ ()~~~In patient		1						1	CSF test abnormal; Gait disturbance; Guillain-Barre syndrome; Myasthenic syndrome; Nausea; Respiratory disorder	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0057335	11/18/1993	KS	73.0	72		M	11/15/1993	5NOV93 bilateral arm pain & weakness, 5NOV93 admitted to hosp, 7NOV93 transferred to Med ctr, 9NOV93 on ventilator in ICU w/DX of GBS undergoing plasmapheresis			Y	Y	Y				U	10/19/1993	11/05/1993	17	MRI 6NOV93-degen changes in C-spine	PUB	PUB	none	none	NKA, inc cholestrol, BPH, bradycardia, positional vertigo	~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome; Respiratory disorder	FLUX~PFIZER\WYETH~4938150~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0057336	11/18/1993	ND	78.0	78		F	11/18/1993	c/o inc weakness, sl dyspnea, & inability to walk. Recvd flu vax 4 day /a. Difficult to get around, fell 4 times, admitted had high respiratory rate, sl dependant edema, defect of sensation below knees, dx GBS, pemphigoid, HTN			Y		Y				Y	10/05/1993	10/19/1993	14	spinal tap done and this was normal, GBS confirmed by Dr.'s studies	PVT	UNK			Pemphigoid, lens implants, gallbladder removed, osteoporotic back fractures;	~ ()~~~In patient	ND93019	1						1	Asthenia; Dyspnoea; Guillain-Barre syndrome; Hypertension; Hyperventilation; Hypokinesia; Oedema; Paraesthesia	FLUX~PFIZER\WYETH~4938091~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0057337	11/18/1993	KS	65.0	65		F	11/15/1993	8NOV93 hosp w/weakness; 10NOV93 transferred to med cntr on ventilator; in ICU w/dx of GBS;11NOV93 being plasmapheresed;hx of URI 1 wk prior to sx onset;			Y	Y	Y				U	10/21/1993	11/08/1993	18	10NOV93 LP neg	PVT	PVT	amoxicillin, ceftin, niacin	none	nka; inc chol; inc lipids; eczema; chronic nasal congestion;	~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome; Respiratory disorder	FLUX~PFIZER\WYETH~4938150~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0057338	11/18/1993	FL	29.0	29		F	11/18/1993	ascending polyradiculopathy of guillain barre			Y	Y	Y				N	10/07/1993	10/20/1993	13		UNK	UNK		none	PNC allergy	~ ()~~~In patient		1						1	Guillain-Barre syndrome; Neuropathy	FLU3~PARKE-DAVIS~1263P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation	Influenza
0057339	11/18/1993	FL	54.0	54		F	11/18/1993	seen in ER 29Oct /c lower extremity weakness, pain, both legs & back since 13Oct-was seen in another ER (X-rays-neg). c/o inability to walk					Y	13			N	09/23/1993	10/21/1993	28	xrays-neg	PVT	PVT			HTN, allerg to PCN, IVP, Norflex, Demorol	~ ()~~~In patient		1						1	Asthenia; Back pain; Guillain-Barre syndrome; Hypokinesia; Pain; CSF test abnormal; Guillain-Barre syndrome; Infection; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~3F41122~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~3F41122~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0057483	11/18/1993	ME	55.0	55		F	11/12/1993	28OCT stomach flu that lasted 3 days; 7NOV bad cold, sore throat, lung congestion, temp;									Y	10/20/1993	10/28/1993	8	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	ME93052	1						1	Influenza; Lung disorder; Pharyngitis; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~4938217~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057484	11/18/1993	ME	43.0	43		F	11/12/1993	arm hurt immed still hurts, diarrhea, very tired 1st & 2nd day p/immun;									N	11/08/1993	11/08/1993	0	NONE	PVT	PVT	Hormone pills	NONE	hayfever	NONE~ ()~~~In patient	ME93053	1						1	Asthenia; Diarrhoea; Pain	FLUX~PFIZER\WYETH~4938119~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057488	11/18/1993	SC	53.0	53		F	11/09/1993	red spot about silver dollar size on arms w/swelling itching, hot to touch x 3 days; lt thumb & index finger joints throb; lt arm feels weak;									Y	11/03/1993	11/04/1993	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	SC93130	1						1	Arthralgia; Injection site hypersensitivity; Injection site oedema; Myasthenic syndrome; Pain; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41007~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057489	11/18/1993	SC	23.0	23		F	11/08/1993	3NOV93 pt states had redness, knot under skin, aching in arm; splotches on skin 3-4 inches; h/a began in 24 hrs;									Y	11/03/1993	11/03/1993	0		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	SC93131	1						1	Headache; Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~CONNAUGHT LABORATORIES~3F41007~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057491	11/18/1993	TN	64.0	64		F	11/08/1993	very weak; achy joints, malaise, low grade t100;									Y	10/26/1993	10/27/1993	1	NA	PUB	PUB	hormone (premmerin);	NA	allergies (hayfever)	NA~ ()~~~In patient	TN93106	1						1	Arthralgia; Asthenia; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4938183~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057493	11/18/1993	TN	71.0	71		M	11/09/1993	flu like sx-temp, aching, loss of voice;										10/22/1993	11/05/1993	14		PUB	PUB				~ ()~~~In patient	TN93108	1						1	Dysphonia; Influenza; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~4938183~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057495	11/18/1993	TN	2.0	2	.2	M	11/12/1993	allergic react-hives & fever;										11/12/1993				PUB	PUB				~ ()~~~In patient	TN93110	1						1	Hypersensitivity; Pyrexia; Urticaria	FLUX~PFIZER\WYETH~4938138~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057506	11/19/1993	AL	62.0	62		F	11/01/1993	severe pain, swelling @ inject site rt arm w/in 2 hrs of inject; pain extending into lower arm & hand; redness rt arm x 6 days; seen by MD 29OCT93; rx ATB:				Y					Y	10/27/1993	10/27/1993	0	NA	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	AL93045	1						1	Injection site oedema; Injection site pain; Pain; Vasodilatation	FLUX~PFIZER\WYETH~4938149~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1042V~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0057524	11/19/1993	AR	38.0	38		M	10/27/1993	states began feeling ill 23OCT93; states on 24-25OCT was out of head, could not eat, got the the bathroom but admit to urinating some; began coughing up phelgm; states wife said pt was covered w/ red blotches;									Y	10/20/1993	10/23/1993	3	NONE	PUB	PUB	NONE	NONE	Denies	~ ()~~~In patient	AR9373	1						1	Anorexia; Cough; Malaise; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~3F41032~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057525	11/19/1993	AR	50.0	50		F	11/11/1993	t101 28OCT93-31OCT93, malaise, nasal congestion;									Y	10/18/1993	10/28/1993	10	NONE	PUB	UNK		NONE	UNK	~ ()~~~In patient	AR9374	1						1	Malaise; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~3F41032~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057526	11/19/1993	AR	57.0	57		M	11/01/1993	t101 28OCT93-31OCT93 low grade temp 1NOV93, nasal congestion, malaise;									Y	10/18/1993	10/28/1993	10	NONE	PUB	UNK		NONE	UNK	~ ()~~~In patient	AR9375	1						1	Malaise; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~3F41032~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057527	11/19/1993	AR	7.0	7		F	11/04/1993	mom brought pt into clinic requesting RN to check rash; pt noticed rash on 3NOV93 p/wearing new winter clothing that had not been washed (wool type); generalized rash prickly itching, starting on abdo-then to tender areas of arms & legs;										11/02/1993	11/03/1993	1	NONE	PUB	PVT	NONE	NONE	hx of skin rashes	NONE~ ()~~~In patient	AR9376	1						1	Condition aggravated; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~3F41032~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057530	11/19/1993	MA	85.0			M	11/16/1993	GBS;			Y	Y	Y		Y			10/04/1993	10/22/1993	18		PUB	UNK			hx of GBS 25 yrs ago;	~ ()~~~In patient	MA9359	1						1	Guillain-Barre syndrome; Paraesthesia; Respiratory disorder; Gait disturbance; Guillain-Barre syndrome; Myasthenic syndrome; Nausea; Paraesthesia; Respiratory disorder; Vomiting	FLUX~PFIZER\WYETH~4938144~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938144~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLUX~PFIZER\WYETH~4938144~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Life Threatening,Hospitalisation	Influenza
0057531	11/19/1993	MA	22.0	22		F	11/08/1993	Grand mal seizure shortly p/receiving  flu vax; seen @ ER & admitted to ICU @ 520PM; valium & phenob given to bring out of sz; dx grand mal sz;				Y	Y	3			Y	10/07/1993	10/07/1993	0	Tegretol & dilantin levels very low;	OTH	PUB	Tegretol, Dilantin	prev sz disorder	sz disorder;	~ ()~~~In patient	MA9360	1						1	Condition aggravated; Grand mal convulsion	FLUX~PFIZER\WYETH~4938150~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0057533	11/19/1993	NM	75.0	75		F	11/01/1993	swelling on lt deltoid w/rash starting on lt arm spreading to entire body;				Y					Y	10/22/1993	10/27/1993	5		OTH	PUB	UNK	denied	NKDA	~ ()~~~In patient	NM93013	1						1	Injection site oedema; Rash	FLUX~PFIZER\WYETH~4938153~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057536	11/19/1993	NY	41.0	41		F	11/15/1993	redness @ inject site, burning, swelling of extremities from site to fingers;				Y					Y	11/11/1993			NA	PVT	PVT	Choledyl, Librax, Alupent, Cartate;	NONE	allergies NONE/asthma;	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Pain	FLU3~CONNAUGHT LABORATORIES~3F41008~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0057538	11/19/1993	FL	61.0	61		F	11/08/1993	pt c/o pain lt arm, neck, chest stated started immediately p/inject & is persisting;				Y					U	11/08/1993	11/08/1993	0	EKG;	PUB	PVT			codeine sulfa	~ ()~~~In patient		1						1	Chest pain; Neck pain; Pain	FLUX~PFIZER\WYETH~4938169~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057539	11/19/1993	MA	46.0	46		M	11/17/1993	c/o of throat feeling tight; seen by MD about 2 wks ago who did throat culture strep; pt was told culture neg; dx was pharyngitis &/or bronchitis; c/o throat tightness, hacky cough, nasal congestion & drainage;				Y						10/28/1993	11/03/1993	6		PVT	PUB	Denied	sl URI sx (t97.6 tympanic);	allergies; mites, dust, animals;	~ ()~~~In patient		1						1	Bronchitis; Condition aggravated; Cough; Laryngospasm; Rhinitis	FLUX~PFIZER\WYETH~4938083~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057543	11/19/1993	IL	43.0			F	11/09/1993	generalized rash 2 wk p/vax;									Y		11/02/1993		NONE	PVT	UNK		NONE	NONE	~ ()~~~In patient		1						1	Rash	FLU3~PARKE-DAVIS~00863P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057341	11/22/1993	MA	59.0	59		M	11/08/1993	pt rcvd flu vax (1993-94 formula) on 25OCT93; 8 days later developed weakness in legs & ascending paralysis of legs; admitted to hosp w/dx of GBS;				Y	Y				U	10/25/1993	11/04/1993	10		PUB	OTH	unk	unk		~ ()~~~In patient	893313016J	1						2	Guillain-Barre syndrome; Coordination abnormal; Guillain-Barre syndrome; Hyporeflexia; Myasthenic syndrome; Neuropathy; Paraesthesia; Paralysis; Paralysis flaccid	FLUX~PFIZER\WYETH~4938151~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0057530	11/22/1993	MA	85.0	85		M	11/08/1993	pt had GBS 25-26 yrs ago; pt rcvd flu vax (1993-94 formula) & 17 days later devel GBS w/nausea, vomiting, unsteady gait & weakness in legs; admitted to hosp, now on ventilator;			Y	Y	Y		Y		U	10/04/1993	10/22/1993	18		PVT	PVT	unk	unk	Hx of GBS 25 yrs ago;	~ ()~~~In patient	893313017J	1						3	Guillain-Barre syndrome; Paraesthesia; Respiratory disorder; Gait disturbance; Guillain-Barre syndrome; Myasthenic syndrome; Nausea; Paraesthesia; Respiratory disorder; Vomiting	FLUX~PFIZER\WYETH~4938144~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938144~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLUX~PFIZER\WYETH~4938144~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Life Threatening,Hospitalisation	Influenza
0057546	11/22/1993	ND	60.0	60		F	11/09/1993	pt rcvd flu vax (1993-94 formula) on 20OCT93; treated w/Seldane for unk sx; admitted to ICU 06NOV93 w/dx of GBS;					Y				U	10/21/1993	11/05/1993	15		PUB	PUB	NONE	none	none	~ ()~~~In patient	893315009J	1						1	Bursitis; CSF test abnormal; Guillain-Barre syndrome; Pain; Paraesthesia; Paralysis; Respiratory disorder; Guillain-Barre syndrome; Neuropathy; Paralysis; Respiratory disorder; Bursitis; CSF test abnormal; Guillain-Barre syndrome; Hemiplegia; Pain; Paraesthesia; Paralysis; Respiratory disorder	FLUX~PFIZER\WYETH~4938140~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938140~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLUX~PFIZER\WYETH~4938140~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Hospitalisation	Influenza
0057549	11/22/1993	MO	76.0	76		U	11/12/1993	30OCT93 malaise, aching, low back pain;02NOV93 rx'd w/rimantidine, keflex;03NOV93 tingling lower extr; admitted to hosp;07NOV93 transferred to regional hosp w/dx post flu vax GBS;09NOV93 on ventilator;			Y		Y		Y		U	10/20/1993	10/30/1993	10	05NOV93 CSF glucose 72, protein 107; WBC 3, RBC 14; gram stain neg	PUB	PUB	vasotec	none	hypertension	~ ()~~~In patient	MO93104	1						1	Back pain; CSF test abnormal; Guillain-Barre syndrome; Malaise; Myalgia; Paraesthesia; Respiratory disorder	FLU3~CONNAUGHT LABORATORIES~3F41124~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0057551	11/22/1993	IL	70.0	70		F	11/03/1993	Pt recvd flu vax & devel aplastic anemia & was hospitalized;			Y	Y	Y	5			U	10/15/1993	11/01/1993	17		OTH	OTH	unk	unk	Kidney stones, status post prostate surgery;	~ ()~~~In patient	893313001J	1						1	Anaemia; Aplastic anaemia; Asthenia; Bone marrow depression; Laboratory test abnormal; Leukopenia; Petechiae; Thrombocytopenia	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0057556	11/22/1993	AZ	64.0			F	11/15/1993	generalized rash, fever & toxic appearance are reported in a pt 6 days p/vax; pt ex generalized rash & a fever of 101; pt was evaluated in ER:					Y				U	10/29/1993	11/04/1993	6	fever of 101;	PVT	OTH	N/S	N/S	N/S	N/S~ ()~~~In patient	27557	1						1	Pyrexia; Rash	FLU3~PARKE-DAVIS~00763P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0057557	11/22/1993	FL	64.0	64		F	11/12/1993	muscle spasms in legs are reported in a pt who recvd flu vax approx 1 wk p/pt recvd vax devel twinges of the leg muscle which persist; pt was hospitalized on 9NOV93 & spinal tap is scheduled;					Y				U	09/15/1993	09/15/1993	0	N/S	OTH	OTH	Lopid (gemfibrozil); Ecotrin (aspirin);	N/S	GBS in AUG89;	N/S~ ()~~~In patient	27536	1						1	Blood creatine phosphokinase increased; Hypertonia; Myalgia; Myopathy; Myositis	FLU3~PARKE-DAVIS~00673~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0057570	11/22/1993	GA	64.0	64		F	10/01/1993	28SEp93 phone call from pt took flu vax in rt arm 27SEP 830AM-arm became swollen, red, hot to touch w/pain; thinks had fever during the noc w/sweats;									Y	09/27/1993	09/27/1993	0		OTH	PUB	Darvocet-pain; Synthoid for thyroid; Valtorin-arthritis;	NONE	thyroid & arthritis	~ ()~~~In patient	GA93192	1						1	Hyperhidrosis; Oedema peripheral; Pain; Pyrexia; Vasodilatation	FLUX~PFIZER\WYETH~4938187~4~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057572	11/22/1993	GA	57.0	57		F	10/05/1993	c/o felt weird immed p/shot given; face deep red pupils largely dilated w/body jerking; eyes rolled back in head; BP 196/106; HR 118 & irreg;									U	09/30/1993	09/30/1993	0		PUB	PUB		NONE	hypertension-allergic xray dye & shrimp;	NONE~ ()~~~In patient	GA93194	1						1	Arrhythmia; Condition aggravated; Gaze palsy; Muscle twitching; Mydriasis; Tachycardia; Vasodilatation	FLUX~PFIZER\WYETH~4938084~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057579	11/22/1993	GA	73.0	72		F	10/12/1993	bruise noted lt arm @ site of inject nausea, eyes feel puffy-felt bad starting the day p/inject;										10/05/1993	10/06/1993	1		PUB	UNK		NONE	Allergies to Darvon; PCN; PB;	~ ()~~~In patient	GA93201	1						1	Ecchymosis; Face oedema; Malaise; Nausea	FLUX~PFIZER\WYETH~4938151~5~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057580	11/22/1993	GA	68.0	68		F	10/20/1993	pt recvd vax stated wife has recvd shot 1OCT93; following shot began not feeling well & subsequently pneumonia; in critical condition on vent;			Y		Y				U	10/01/1993	10/03/1993	2	Not known;	PUB	PUB	NONE	NONE		~ ()~~~In patient	GA93203	1						1	Malaise; Pneumonia	FLUX~PFIZER\WYETH~4938084~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0057583	11/22/1993	GA	20.0	20		F	10/26/1993	c/o nausea, sore throat, tired, coughed up, blood-tinged mucus x 2;				Y					U	10/05/1993	10/07/1993	2		PUB	UNK		NONE		~ ()~~~In patient	GA93206	1						1	Asthenia; Haemoptysis; Nausea; Pharyngitis	FLU3~PARKE-DAVIS~01263P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0057586	11/22/1993	MA	68.0	68		F	11/03/1993	19OCT93 woke up w/violent dizzy spell cont off & on x 2 wks; nausea, body aches arm & leg tingling both hands; redness-swelling lt arms; viral ear infect;				Y						10/18/1993	10/19/1993	1		PUB	PUB	NA	NONE	NA	~ ()~~~In patient	MA9358	1						1	Dizziness; Infection; Myalgia; Nausea; Oedema peripheral; Otitis media; Paraesthesia; Vasodilatation	FLUX~PFIZER\WYETH~4938083~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~MASS. PUB HLTH BIOL LAB~TD52~UNK~IM~~TD ADSORBED (TDVAX)~1	USA	Emergency room visit	Influenza
0057587	11/22/1993	MA	71.0	71		F	11/18/1993	c/o stiff neck & pain in joints x 2 1/2 wks duration post inject;									Y	10/06/1993	10/07/1993	1		PUB	PUB			had surgery on leg;	~ ()~~~In patient	MA9361	1						1	Arthralgia; Nuchal rigidity	FLUX~PFIZER\WYETH~4938083~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057588	11/22/1993	ME	63.0	63		F	11/16/1993	felt sick all over woke up 2AM; rt arm very painful 3 nodules-red, raised, h/a stiff neck, chills, temp 101.5, vomiting;				Y					N	11/12/1993	11/12/1993	0	NONE	PVT	PVT	Sulindac; Amitrittyline;	NONE	NONE	NA~ ()~~~In patient	ME057	1						1	Chills; Headache; Malaise; Nuchal rigidity; Pyrexia; Skin nodule; Vasodilatation; Vomiting	FLU3~PARKE-DAVIS~00963P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~360959~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0057589	11/22/1993	MO	41.0	41		F	11/01/1993	red itchy rash appeared the next day on lower extremities, arms, necks, back;									Y	10/25/1993	10/26/1993	1		OTH	UNK	NONE	NONE		~ ()~~~In patient	MO93101	1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~3F41033~UNK~L~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057591	11/22/1993	MO	79.0	79		F	11/08/1993	res noted to have red dots covering trunk & extrem sl raised, c/o itching;									U	10/26/1993	10/27/1993	1	NONE	OTH	PUB	Bumex, Vasotec, K+, Alloupurinol, Lasix, Lanoxin, Aldactazide, Darvocet, Lorazepam;	CHF, HTN, CAD, Chr atrial fib, Osteoarth	senile dementia; NKA;	NONE~ ()~~~In patient	MO93103	1						1	Pruritus; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~3F41123~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057594	11/22/1993	MS	48.0	48		F	11/11/1993	redness surrounding inject site, warm to touch, minor discomfort; inc redness & heat;									Y	11/09/1993	11/09/1993	0		PUB	UNK	NONE	NONE		~ ()~~~In patient	MS93049	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057597	11/22/1993	NE	74.0			F	11/05/1993	c/o weakness & tiredness starting 4NOV; site of inject sl sore; states also has sl cough, congestion & nasal discharge, lightheadedness h/a;									U	11/02/1993	11/04/1993	2	NA	PUB	PUB	Lopressor & thyroid;	NONE	hypertension	NONE~ ()~~~In patient	NE9322	1						1	Asthenia; Condition aggravated; Cough; Dizziness; Headache; Injection site pain; Rhinitis	FLU3~PARKE-DAVIS~00573P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057600	11/22/1993	NY	65.0	65		M	10/25/1993	In bed x 3days pt reports weakness, dizziness, sl chills, h/a, flu-like severe sx;									Y	10/22/1993	10/22/1993	0	NONE	PUB	PUB		NONE	NONE	~ ()~~~In patient	NYS93073	1						1	Asthenia; Chills; Dizziness; Headache; Influenza	FLU3~CONNAUGHT LABORATORIES~3F41035~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057611	11/22/1993	NY	67.0	66		M	11/10/1993	Pt was found dead at home, no s/s or complaints, pt had existing condition of severe arrhythmia, severe cardiac conditions;	Y	10/08/1993							N	10/07/1993	10/08/1993	1		PVT	OTH		only condition listed #19	hx of caridac problems/MI 11AUG93; was due for stress test surgery testing 8OCT93;	~ ()~~~In patient		1						1	Arrhythmia	FLU3~PARKE-DAVIS~00573P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~~PNEUMO (NO BRAND NAME)~1	USA	Results in Death	Influenza
0057612	11/22/1993	NY	79.0	79		F	11/10/1993	flu shot given 23OCT92 during 7-3shift; 4Pm t99.4; 930PM temp 102; pt died 945 PM;	Y	10/23/1993							N	10/23/1993	10/23/1993	0		OTH	OTH		no other listed conditions ;	cardiac problems/ASHD/COPD/MI	~ ()~~~In patient		1						1	Dyspnoea; Myocardial infarction; Pyrexia	FLUX~PFIZER\WYETH~4938185~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0057615	11/22/1993	VT	28.0	28		F	11/10/1993	nausea, flushed, palpitats/tachycardia;				Y					Y	10/19/1993	10/20/1993	1	NONE	OTH	OTH	BCP's;	NONE	endometrosis	~ ()~~~In patient		1						1	Nausea; Palpitations; Tachycardia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057618	11/22/1993	WI	71.0	71		M	11/16/1993	nausea & vomiting 24 hrs post flu shot; began 4NOV93 in the morning; came to ER 1735 given Phenergan;				Y					Y	11/03/1993	11/04/1993	1	NONE	PUB	PVT	ASA	NONE	HTN, Hypercholesteromia;	NONE~ ()~~~In patient		1						1	Nausea; Vomiting	FLUX~PFIZER\WYETH~4938160~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057619	11/22/1993	CO	32.0	32		F	11/18/1993	large sore area on lt arm inject on 21OCT size 4 went to MD on 29OCT93 was given ATB for 5 days;				Y					Y	10/29/1993	10/29/1993	0	NONE	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site pain	FLUX~PFIZER\WYETH~3F41032~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057622	11/22/1993	FL	50.0	50		F	11/16/1993	pt exp hives on buttocks 2 days p/flu shot; on the 3rd day hives spread w/swelling of hands & feet;				Y					Y	10/13/1993	10/15/1993	2	NA	PUB	PVT	Estroderm patch	NONE	tetanus	~ ()~~~In patient		1						1	Oedema peripheral; Urticaria	FLUX~PFIZER\WYETH~4938161~1~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057625	11/22/1993	GA	38.0	38		F	11/19/1993	pt minimal redness & no swelling @ inject site states inject was painful & arm cont to throb p/inject; difficult to use lt arm w/in  hrs of the vax; swelling in fingers;									N	11/17/1993	11/17/1993	0		OTH	OTH				~ ()~~~In patient		1						1	Hypokinesia; Injection site hypersensitivity; Injection site pain; Oedema peripheral; Pain	FLU3~CONNAUGHT LABORATORIES~3F41032~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057632	11/22/1993	CO	43.0	43		F	10/29/1993	c/o sore swollen red hard & hot to touch @ inject site; recvd flu shot on 26OCT93; 29OCT93 site was improved; 3-4 diameter;									Y	10/26/1993	10/27/1993	1	NONE	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41032~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057633	11/22/1993	CO	40.0	40		M	11/19/1993	had gradual onset of sore red lump up to diameter of 4 w/max on 18NOV today feels it is less;									Y	11/15/1993	11/17/1993	2	NONE	OTH	PVT	NONE	NONE	Demerol	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~CONNAUGHT LABORATORIES~3F41032~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057634	11/22/1993	CO	37.0	37		F	11/19/1993	c/o sore arm on afternoon of inject; has remained same till present; has not taken anything for arm lt 1-2;									Y	11/13/1993	11/13/1993	0	NONE	OTH	PVT	NONE	NONE	codeine-coffee beans;	~ ()~~~In patient		1						1	Myalgia; Dysgeusia; Hyperhidrosis; Hypertension; Nausea; Neck pain	FLU3~CONNAUGHT LABORATORIES~3F41032~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~PFIZER\WYETH~361921~1~~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~2	USA		Influenza
0057638	11/22/1993	NE	17.0	17		F	11/17/1993	pt recvd flu vax 1030AM & 6PM onset jittery, nervous feeling tremulous in hands; felt weak, dizzy 17JAN93 pt reports still jittery filling but gradually subsiding;									Y	11/16/1993	11/16/1993	0	NONE	PVT	PVT	Depoprovera inject;	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Dizziness; Nervousness; Tremor	FLUX~PFIZER\WYETH~4938141~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057641	11/23/1993	NY	62.0			F	11/17/1993	stroke, pleocytosis, homonymous hemianopsia & h/a are reported in pt who recvd flu vax in OCT93; approx 2 wks p/vax pt exp lt temporal h/a & impaired rt vision; pt hospitalized NOV93; dc bilateral homonymous hemianopsia;					Y					10/27/1993	11/10/1993	14	10NOV93 spinal tap revealed 1500cells & 140 monocytes; negative Ct Scan w/contrast MRI;	PVT	OTH	Tenormin (Atenolol)	NA	NA	NA~ ()~~~In patient	27612	1						1	CSF test abnormal; Cerebrovascular accident; Headache; Pleocytosis; Visual disturbance; Visual field defect	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0057644	11/23/1993	MD	38.0	38		F	10/17/1993	fever 100.6, chills, body ache, diarrhea;									Y	10/06/1993	10/10/1993	4		PUB	PUB	Tenormin; Limbitrol;	NONE	spastic colon	NONE~ ()~~~In patient	MD93046	1						1	Chills; Diarrhoea; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~4938149~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057648	11/23/1993	OH	45.0	45		M	10/21/1993	w/in 4 hrs of vax pt devel a red, raised, fine, itching rash on arm & legs;				Y					Y	10/20/1993	10/21/1993	1	NONE	PUB	UNK		NONE	NONE	~ ()~~~In patient	OH93093	1						1	Pruritus; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~3F41008~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0057649	11/23/1993	DE	76.0	76		F	11/10/1993	pt recvd vax 2NOV93; sore arm & cold sx devel-pt hospitalized on 5NOV by MD for pneumonia;					Y	4			U	11/02/1993	11/03/1993	1		PUB	UNK		NONE	NONE	~ ()~~~In patient		1						1	Myalgia; Pharyngitis; Pneumonia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~3F41035~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0057650	11/23/1993	NY	70.0	70		M	11/18/1993	encephalopathy VII cranial nerve complete; paralysis of lt side of face-stabbing pain lt ear; vision blur; bell's palsy;								Y	N	10/25/1993	10/26/1993	1	blood test indicated no lyme disease present;	UNK	PVT		NONE	NONE	NONE~ ()~~~In patient		1						1	Amblyopia; Ear pain; Encephalopathy; Facial palsy	FLU3~CONNAUGHT LABORATORIES~3F41124~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0057651	11/23/1993	TX	44.0	44		F	11/19/1993	8x10 cm red, warm area to rt upper arm @ inject site on day p/inject; react began 1st day p/w/some improvement then began spreading again on 9th day; Advil taken;				Y					U	11/10/1993	11/11/1993	1		OTH	OTH	Capoten, Buspar, Plendil;		NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLUX~PFIZER\WYETH~4938262~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~CONNAUGHT LABORATORIES~3H51024~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057654	11/23/1993	IN	73.0	73		F	11/16/1993	lt arm red upper post aspect w/edema; prescribed DPh;									Y	10/06/1993	10/07/1993	1		PVT	PVT	Lasix, Zestril;	NA	CHF/CRF/HPT	NA~ ()~~~In patient		1						1	Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0057660	11/24/1993	OK	19.0	19		F	11/01/1993	local reaction rt deltoid pain, swelling, inc warmth w/o abscess; seen by MD 1NOV93 dx of localized react w/early infect;									Y	10/30/1993	10/31/1993	1	NA	PUB	PUB	NA	NONE	NONE	NONE~ ()~~~In patient	OK9357	1						1	Infection; Injection site oedema; Injection site pain; Vasodilatation	FLUX~PFIZER\WYETH~4938153~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~344951~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0057661	11/24/1993	TX	23.0			F	10/15/1993	pt was diaphoretic, c/o h/a & stated people talking sounded slow & very far away; treatment was diphenhyramic inject & observation;				Y					Y	10/15/1993	10/15/1993	0	NA	OTH	OTH	Unk	NONE	NONE	NA~ ()~~~In patient		1						1	Deafness transitory; Headache; Hyperhidrosis	FLU3~CONNAUGHT LABORATORIES~3J41019~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0057662	11/24/1993	WI	57.0	57		F	11/17/1993	pt c/o very painful throat, hurts to swallow; no problem breathing or speaking sudden onset 7PM; painful w/swallowing; no fever or chills; recvd flu shot this afternoon;				Y					Y	11/16/1993	11/16/1993	0	02 sat 98%	PVT	PUB	Premarin, Synthroit	NONE	allergy to morphine & IV dye; dx thyroidectomy, hysterectomy, TAH; lumber disc;	NA~ ()~~~In patient		1						1	Dysphagia; Pharyngitis	FLU3~PARKE-DAVIS~01293P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0057665	11/24/1993	MD	45.0	45		M	10/25/1993	21OCT93 chills & fever 102, mild nausea, loss of appetite 3-4 days; sweating, achiness;				Y					Y	10/12/1993	10/21/1993	9	lt ear infect/bronchitis/URI;	PUB	PUB	Maxzide, Capoten, Tenormin;	NONE	hypertension	~ ()~~~In patient		1						1	Anorexia; Bronchitis; Chills; Hyperhidrosis; Myalgia; Otitis media; Pharyngitis; Pyrexia	FLU3~PARKE-DAVIS~00963P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0056820	11/26/1993	KY	21.0	21		F	11/22/1993	1-hr p/flu vax found on floor non responsive, no pulse, no resp; CPR initiated;				Y					Y	10/08/1993	10/08/1993	0	NA	OTH	OTH	NONE	devel chicken pos 2 wks post flu inject	NA	NA~ ()~~~In patient		1						2	Anaphylactoid reaction; Apnoea; Cardiac arrest; Syncope; Apnoea; Cardiac arrest; Stupor	FLU3~PARKE-DAVIS~01173P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~01173P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0057546	11/26/1993	ND	60.0	60		F	11/23/1993	ascending neuropathy & paresis;					Y				N	10/20/1993	11/05/1993	16		PUB	PUB	Naprosin, Ibuporfin	bursitis	NONE	~ ()~~~In patient	ND93020	1						2	Bursitis; CSF test abnormal; Guillain-Barre syndrome; Pain; Paraesthesia; Paralysis; Respiratory disorder; Guillain-Barre syndrome; Neuropathy; Paralysis; Respiratory disorder; Bursitis; CSF test abnormal; Guillain-Barre syndrome; Hemiplegia; Pain; Paraesthesia; Paralysis; Respiratory disorder	FLUX~PFIZER\WYETH~4938140~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938140~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLUX~PFIZER\WYETH~4938140~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Hospitalisation	Influenza
0057670	11/26/1993	TX	76.0			M	11/19/1993	SOB & unable to sleep are reported in a pt who recvd flu vax; pt exp insomnia for 1 wk following flu vax; exp SOB;					Y	3			Y	10/06/1993			unspecified cultures--revealed pt was sick;	PVT	OTH		NA	NA	NA~ ()~~~In patient	26877	1						1	Dyspnoea; Insomnia	FLU3~PARKE-DAVIS~00763P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0057673	11/26/1993	CO	60.0	59		M	10/21/1993	15OCT injection-pain muscle ache; 20OCT itching both legs starting @ groin working down; welts; red spots; redness;									Y	10/15/1993	10/20/1993	5		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	CO93076	1						1	Myalgia; Pain; Pruritus; Rash; Urticaria; Vasodilatation	FLUX~PFIZER\WYETH~4938180~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057675	11/26/1993	CO	56.0	56		M	11/08/1993	pt recvd flu vax 20OCT93 & on 21OCT w/in 24 hrs devel h/a & fever, myalgia; visited ER on 30OCT; spinal tap 61-69 WBC/ml, protein 76 inc; dx aseptic meningitis;				Y					Y	10/20/1993	10/21/1993	1	61-69 WBC/ml, protein 76 inc;	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	CO93078	1						1	CSF test abnormal; Headache; Meningitis; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41029~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0057676	11/26/1993	CO	29.0	28		F	11/01/1993	pt recvd flu vax 27OCT93 c/o nausea, vomiting, low grade fever 98.9 starting 28OCT-1NOV93 assoc w/cough & body aches; to contact MD									N	10/27/1993	10/28/1993	1		PVT	PVT	Birth control pills	NONE	NONE	NONE~ ()~~~In patient	CO93079	1						1	Cough; Myalgia; Nausea; Pyrexia; Vomiting	FLUX~PFIZER\WYETH~4938150~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057677	11/26/1993	CO	58.0	58		F	11/01/1993	pt had flu shot 22OCT93 & 29OCT93 c/o achiness w/fever; did not take temp APAP seemed to help sx; 1NOV93 called to say still ached, c/o head cold & swollen tender lymph nodes on rt side of neck; referred to MD:									Y	10/22/1993	10/29/1993	7	NONE	PUB	PUB	Glaucoma	NONE	glaucoma	NONE~ ()~~~In patient	CO93080	1						1	Lymphadenopathy; Myalgia; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~4938180~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057678	11/26/1993	CO	52.0	52		F	10/26/1993	pt recvd vax 18OCT93 & 20OCT93 c/o feeling cold & achy; was very fatigued; had a severe h/a & fever of 100.5; r/o infect;									Y	08/18/1993	10/20/1993	63	NONE	PUB	PUB	Premarin	c/o mild cough	sensitive airways;	NONE~ ()~~~In patient	CO93081	1						1	Asthenia; Chills; Headache; Infection; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~4938180~1~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057702	11/26/1993	NH	63.0	63		M	11/18/1993	24OCT93 sore throat x 1 wk; went to MD put on ATB;				Y					Y	10/21/1993	10/24/1993	3	NA	PUB	PUB	Calan, Sinemet, Eldphrie;	NONE	angioplasty	NA~ ()~~~In patient	ME93054	1						1	Pharyngitis	FLU3~CONNAUGHT LABORATORIES~3F41132~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0057703	11/26/1993	ME	62.0	62		F		arm was achy, shoulder hurt; x-rays 27OCT93; follow up visit 4OCt93; another appt scheduled; this wk;				Y					N	10/06/1993	10/06/1993	0	x-rays;	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	ME93055	1						1	Myalgia; Pain	FLUX~PFIZER\WYETH~4938119~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057704	11/26/1993	ME	69.0	69		F	11/17/1993	local swelling, moderate getting better;				Y					Y	11/04/1993	11/06/1993	2	NONE	UNK	UNK	NONE	NA		NA~ ()~~~In patient	ME93056	1						1	Injection site oedema	FLU3~PARKE-DAVIS~01273P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0057705	11/26/1993	ME	39.0	39		F	11/16/1993	lose of voice, sinus infect, bronchitis;				Y					Y	11/01/1993	11/09/1993	8	NA	PUB	PUB	NA	NONE	NONE	NA~ ()~~~In patient	ME93058	1						1	Bronchitis; Dysphonia; Sinusitis	FLU3~PARKE-DAVIS~4938119~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0057706	11/26/1993	MO	73.0	73		F	11/15/1993	felt draggy (malaise all day 1NOV93; severe h/a w/vomiting devel; h/a lasted 3 days; had fever (did not take) one evening; coughing; lasted 5 days altogether; called MD;									Y	10/22/1993	11/01/1993	10	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MO93106	1						1	Cough; Headache; Malaise; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~3F41123~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057707	11/26/1993	MO	67.0	67		F	11/12/1993	flu shot 29OCT93; 30OCT93 about noon felt achy 31OCT93 woke up about 5AM w/severe abdo cramps, nausea & diarrhea; started getting better Sunday PM & felt OK by 5PM x/for weakness which lasted approx 5 days;									Y	10/29/1993	10/30/1993	1	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MO93107	1						1	Abdominal pain; Asthenia; Diarrhoea; Myalgia; Nausea	FLU3~CONNAUGHT LABORATORIES~3F41123~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057708	11/26/1993	MO	35.0	35		M	11/12/1993	onset lightheadedness, sl fever, sl aching, sl cough, cold chills, very bad diarrhea for 3 days; temp to 100 po, musle soreness/aching; joint pain, sore throat, cough & dizziness cont until 4NOV93;									Y	10/29/1993	10/29/1993	0	NONE	PUB	PUB		NONE	Codeine allergy;	NONE~ ()~~~In patient	MO93108	1						1	Arthralgia; Chills; Cough; Diarrhoea; Dizziness; Myalgia; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41123~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057709	11/26/1993	MO	38.0	37		F	11/12/1993	flu shot given 29OCT93 in lt deltoid; awakened 30OCT93 w/stiffness in neck on lt side; no temp or other sx; duration approx 6 days;									Y	10/29/1993	10/30/1993	1	NONE	PUB	PUB	NONE	Ganglion cyst drained 25OCT93 lt wrist	NONE	NONE~ ()~~~In patient	MO93109	1						1	Nuchal rigidity	FLU3~CONNAUGHT LABORATORIES~3F41123~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057710	11/26/1993	MO	45.0	45		F	11/12/1993	flu shot given 29OCT93 lt deltoid; stiff neck on lt side onset approx 2PM same day; duration approx 6 days; no other sx;									Y	10/29/1993	10/29/1993	0	NONE	PUB	PUB	NONE	NONE	PCN & sulfa;	NONE~ ()~~~In patient	MO93110	1						1	Nuchal rigidity	FLU3~CONNAUGHT LABORATORIES~3F41123~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057712	11/26/1993	MO	77.0	77		F	11/03/1993	c/o pain in hips & legs; has had trouble w/sleep, all 5 days p/flu vax in lt deltoid; seen by MD 18OCt93 recvd dx of sciatic arthritis, arthritis meds given to pt; 8NOV93 phone call placed to pt & stated felt well;				Y					Y	10/12/1993	10/18/1993	6		PUB	PUB		NNE	Diabetic	~ ()~~~In patient	MO93112	1						1	Arthralgia; Arthritis; Insomnia; Pain	FLU3~CONNAUGHT LABORATORIES~3F41027~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0057713	11/26/1993	MO	74.0	74		F	11/02/1993	pt recvd vax 29OCT93 & on 30OCT93 started itching w/welts; pt put on cortisone cream w/some relief; itching seems worse 2NOV93; referred to MD;									N	10/29/1993	10/30/1993	1		PUB	PUB	Copoten-inc BP, Verapimil;	NONE		~ ()~~~In patient	MO93113	1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~3F41124~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057716	11/26/1993	NH	36.0	36		F	11/04/1993	w/in 24 hrs of vax devel h/a low grade temp 99, myalgia x 48 hrs, then temp to 102.4, w/severe h/a, stiff neck & shoulders cough 4 more days; resolution of temp on day #7-h/a persists although less severe;				Y					Y	10/27/1993	10/28/1993	1	NONE	PVT	UNK	NONE	NONE	s/p splenectomy	~ ()~~~In patient	NH93027	1						1	Cough; Headache; Hypertonia; Myalgia; Nuchal rigidity; Pyrexia	FLUX~PFIZER\WYETH~4938124~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057719	11/26/1993	MO	2.0	2	.8	F		pt recvd flu vax 15OCT sick in a wk or about lack of use lt arm 31OCT;			Y	Y	Y					10/15/1993	10/22/1993	7		OTH	PVT			alzheimers	~ ()~~~In patient		1						1	Hypokinesia; Malaise	FLUX~PFIZER\WYETH~4938180~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0057721	11/26/1993	OH	38.0	38		M	11/19/1993	11NOV93 h/a; 12NOV93 tired/h/a/temp/nausea/neck stiff; 13NOV93 convuls admit hosp viral meningitis, encephalitis, sinus infect;			Y	Y	Y	6			U	11/10/1993	11/11/1993	1		OTH	OTH	unk	NONE	unk	~ ()~~~In patient		1						1	Asthenia; Condition aggravated; Convulsion; Encephalitis; Infection; Meningitis; Nuchal rigidity; Sinusitis	FLU3~PFIZER\WYETH~2243GB~1~IM~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Life Threatening,Hospitalisation	Influenza
0057726	11/26/1993	KY	20.0	20		F	11/22/1993	w/in 5 mins of inject, subject became unconscious;				Y					Y	09/05/1993	09/05/1993	0	NA	OTH	OTH	NONE	NONE	NONE	pt exp unconscious w/Hep B vax 14JUl92; rxn also reported to hlth dept & MD;~ ()~~~In patient		1						1	Syncope	FLU3~PARKE-DAVIS~01173P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0057732	11/26/1993	MA	56.0	56		F	11/20/1993	6 hrs p/vax eyes became irritated, red, swollen, shaking chills & fever 102+ lasted 4-6 hrs w/APAP 7 DPH;									Y	10/08/1993	10/08/1993	0	NONE	PUB	UNK	Gamma Globulin;	NA	sulfa allergy	~ ()~~~In patient		1						1	Chills; Conjunctivitis; Face oedema; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057735	11/26/1993	KS	22.0	22		F	11/21/1993	2 wks so far; nausea, h/a, cold & flu sx, lethargic;									N	10/27/1993	11/08/1993	12	NONE	OTH	OTH	Birth control pills, Amitryptiline, Ditropan	NONE	sulfa drugs allergy	~ ()~~~In patient		1						1	Headache; Influenza; Nausea; Pharyngitis; Rhinitis; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057736	11/26/1993	MA	63.0	63		F	11/20/1993	felt queasy 31NOV but not debilitated; diarrhea 1NOV @ 902Am; had cough & generally felt lousy until 8NOV: felt like a cold but no runny nose, etc;									Y	10/20/1993	10/31/1993	11	NA	PUB	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Cough; Diarrhoea; Malaise; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057737	11/26/1993	OR	68.0	68		F	11/16/1993	urticaria over entire body w/in 24 hrs of vax;									Y	10/26/1993	10/27/1993	1		PVT	PVT				~ ()~~~In patient		1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~3F41125~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057740	11/29/1993	CA	67.0			M	11/18/1993	pt recvd vax & exp local react for 3 days followed by development of leukopenia & acute respiratory distress; pt was hospitalized; lab tests showed WBC Count 1.7 & CXr showed lt lung infiltrate & poss pneumonia;			Y		Y				U	10/25/1993	10/28/1993	3	CXR poss lung infiltrate; WBC 1.7;	UNK	UNK			pulmonary fibrosis, s/p pneumonia, retrosternal burning, nonradiating chest pain; emphysema, allergy bee stings & brandy; diverticulitis, recurrent syncope, low back pain, COPD, hypocalcemia, inc carcinoembryonic antigen; hypercholesterolem	~ ()~~~In patient	WAES93110184	1						1	Dementia; Hyponatraemia; Hypoxia; Infection; Injection site hypersensitivity; Leukopenia; Pneumonia; Tachycardia	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~~~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0057742	11/29/1993	MO	11.0	11		F	11/15/1993	pt had sz approx 2 hrs p/receiving vax;									Y	10/05/1993	10/05/1993	0	Tegretol level next day 10.7 (w/in therapeutic range);	PVT	PUB	Tegretol	NONE	allergic to Ceclor; E-mycin; cerebral palsy, hydrocephalus; sz dx since age 3;	NONE~ ()~~~In patient	MO93116	1						1	Condition aggravated; Convulsion	FLUX~PFIZER\WYETH~4938184~3~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~1204V~2~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0057746	11/29/1993	MT	26.0	26		F	11/04/1993	pt recvd flu shot & devel itching on back 345PM; no allergies, no prior flu shot; nor recent illness or known egg allergy; mild small patches of erythema & upper & lower back in areas of itching &  scratching;									Y	10/27/1993	10/27/1993	0	NONE	PVT	PVT	NKDA	NONE	NONE	~ ()~~~In patient	MT93039	1						1	Pruritus; Rash	FLUX~PFIZER\WYETH~4938226~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057749	11/29/1993	NE				F	11/03/1993	felt lethargic Sat, but no s/s; Sunday had t102 oral, upper resp congestion & achiness; also c/o h/a sinus pain & sore throat; took APAP cold capsules; pt coughing up green mucus & nasal/sinus congestion;									U	10/28/1993	10/31/1993	3	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	NE9323	1						1	Cough; Headache; Myalgia; Pharyngitis; Pyrexia; Rhinitis; Sinusitis; Somnolence	FLU3~PARKE-DAVIS~00573P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057762	11/29/1993	WI	69.0	69		M	10/11/1993	devel fever of 103 by 630PM 8OCT93; called MD & was seen 9OCT93; cold sx cough & h/a; MD stated it was caused by the flu shot; pt was given rx of Ceclor;				Y					Y	10/08/1993	10/08/1993	0	NONE	PUB	PVT	Cardizem	NONE	hx cancer	~ ()~~~In patient	WI93074	1						1	Cough; Headache; Pharyngitis; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~4938147~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057766	11/29/1993	WI	78.0	78		F	10/24/1993	lt arm red & hot; no fever, lightheaded, hurt all over, no appetite-sx began 7OCT93; warm, hard area on arm still on 12OCt93;									Y	10/07/1993	10/08/1993	1	NA	PUB	PVT		NONE	NONE	~ ()~~~In patient	WI93078	1						1	Anorexia; Dizziness; Pain; Skin nodule; Vasodilatation	FLUX~PFIZER\WYETH~4938168~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1042V~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0057767	11/29/1993	WI	68.0	68		M	10/29/1993	became ill 13OCT93 w/chills possible fever, nausea; unable to eat; felt cold, freezing;									Y	10/11/1993	10/13/1993	2	NONE	PUB	PVT			paraplegic	~ ()~~~In patient	WI93079	1						1	Anorexia; Chills; Malaise; Nausea; Pyrexia	FLUX~PFIZER\WYETH~4938168~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057770	11/29/1993	WI	40.0	40		F	10/05/1993	burning in back of neck (rt side), swelling-pain, redness, warm to touch,  hardness, chills, poss fever, nausea, h/a, pain started immediately;									Y	10/04/1993	10/04/1993	0	NONE	PUB	PUB		NONE	Codeine	~ ()~~~In patient	WI93082	1						1	Chills; Headache; Nausea; Neck pain; Oedema; Pyrexia; Skin nodule; Vasodilatation	FLU3~PARKE-DAVIS~00583P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~358958~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0057771	11/29/1993	WI	70.0	70		M		pt recvd vax 4APR93 & 5NOV93 did not feel well & felt the sides of face hurt; seen by MD 6NOV93 who said was sinus & ear infect; 7NOV93 had stroke w/no use lt arm & leg & speech slurred;					Y					11/04/1993	11/05/1993	1	lt side paralysis;	PUB	PUB	Micronase-diabetic;; Ibuprofen-arthritis;	NONE	diabetic & arthritis	~ ()~~~In patient	WI93083	1						1	Cerebrovascular accident; Hemiplegia; Malaise; Otitis media; Pain; Sinusitis; Speech disorder	FLUX~PFIZER\WYETH~4938121~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0057772	11/29/1993	WI	36.0	36		F	11/10/1993	started to feel achy in the evening on 6NOV; devel a sore arm w/swelling & redness on 7NOV; also devel diarrhea on 7NOV; GI sx progress to vomiting 9NOV; resolved; arm remains sore to touch; no hardness;									Y	11/06/1993	11/07/1993	1	NONE	PUB	PUB		NONE	NONE	~ ()~~~In patient	WI93084	1						1	Diarrhoea; Myalgia; Oedema peripheral; Vasodilatation; Vomiting	FLU3~PARKE-DAVIS~00583P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1042V~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0057774	11/29/1993	MI	55.0	55		F	11/22/1993	Chart unavailable, but from physician's report developed GBS 10 days post vaccination; still on ventilator;									U	10/07/1993	10/31/1993	24		UNK	UNK				~ ()~~~In patient		1						1	Guillain-Barre syndrome; Respiratory disorder; Asthenia; Guillain-Barre syndrome	FLUX~PFIZER\WYETH~4938181~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938181~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0057775	11/29/1993	MI	73.0	73		M	11/18/1993	Started w/numbness & tingling in hands & legs & then ascending paralysis; now diagnosed w/GBS;			Y						U	11/03/1993	11/13/1993	10	Confirmatory neuromuscular tests;	PVT	UNK		NONE	Hypertension;	~ ()~~~In patient		1						1	Guillain-Barre syndrome; Paraesthesia; Paralysis; Paralysis flaccid	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0057776	11/29/1993	MI	34.0	34		F	11/19/1993	Numbness & tingling in feet, ascending to chest level; now diagnosed w/GBS;					Y				U	10/18/1993	11/18/1993	31		UNK	UNK	Vitamin shots; K-Dur & Micro;	NONE	S/p gastric bypass;	~ ()~~~In patient		1						1	Guillain-Barre syndrome; Paraesthesia; Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~3F41141~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~3F41141~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0057777	11/29/1993	MN	22.0	22		F	11/12/1993	pt devel inc weakness in limbs w/paresthesias in distal extremities;devel difficulty walking; diffuse aching of limbs;some degree of imbalance;lost wt;sleeping excessively;reflexes absent;impression was the pt has GBS;					Y	6			Y	10/01/1993	10/02/1993	1	unremarkable spinal tap	PVT	PVT	none	recovering from pneumonia	none pertinent	~ ()~~~In patient		1						1	Asthenia; Gait disturbance; Guillain-Barre syndrome; Hyporeflexia; Myalgia; Paraesthesia; Somnolence; Weight decreased	FLU3~CONNAUGHT LABORATORIES~3941132~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0057779	11/29/1993	RI				U	11/23/1993	pt devel symptoms/signs consistent w/GBS within several days of recv vax;										11/05/1993	11/14/1993	9		UNK	UNK				~ ()~~~In patient		1						1	Guillain-Barre syndrome; Influenza	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057782	11/29/1993	OR	41.0	41		F	10/01/1993	fever, sore lt arm from shoulder to elbow, swelling of arm specifically medial side above elbow w/erythema; ATB prescribed by MD 30SPE93 unsure if inflammation related to inject;				Y					Y	09/28/1993	09/29/1993	1		PUB	PVT		NONE		~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site inflammation; Injection site oedema; Injection site pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~00763P~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~1042V~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057783	11/29/1993	OH	36.0	36		F	11/26/1993	s/s nausea, vomiting, diarrhea, malaise; acute viral Gastroenteritis;				Y					Y	11/22/1993	11/22/1993	0	NONE	PVT	PVT	Estrogen	NONE	NKA	~ ()~~~In patient		1						1	Diarrhoea; Gastroenteritis; Infection; Malaise; Nausea; Vomiting	FLUX~PFIZER\WYETH~4938192~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057784	11/29/1993	OR	7.0	7		M	11/04/1993	16OCT & 17OCt upper arm hot 7 swollen to itchy; improved each day; 18OCT devel h/a & aching & fever of 104 on 20OCt; had fever next day also & seen by MD;				Y					Y	10/15/1993	10/16/1993	1		PUB	PVT	Tegretol, Slow Bid, Albuterol;	NONE	allergic to everything per mom severe asthma;	pt exp high fever w/DTP;~ ()~~~In patient		1						1	Headache; Myalgia; Oedema peripheral; Pruritus; Pyrexia; Vasodilatation	FLUX~PFIZER\WYETH~4938137~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057788	11/29/1993	WI	15.0	15		M	10/18/1993	3 hrs p/flu vax given pt exp coughing, gagging, diffculty sitting, weak, pale, clear nasal drainage, loud burp & rapid & shallow resp; acting funny; taken to ER; dx presyncope episode;				Y					Y	10/15/1993	10/15/1993	0	physical assessment;	OTH	PUB	Phenobarbital;	NONE	Atropine eye drip allergy (systemic), CP, Total Laryngeal stenosis;	pt's sibling exp inc fever @ 4mos w/DTP #1;~ ()~~~In Sibling		1						1	Asthenia; Cough; Dizziness; Hyperventilation; Pallor; Personality disorder; Rhinitis; Vomiting	FLU3~PARKE-DAVIS~00538P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0057789	11/29/1993	MO	47.0	46		F	11/03/1993	arm swelling 1NOV93; pt stated was swollen twice normal size;									Y	10/30/1993	10/30/1993	0	NONE	PVT	PVT	Azmacort, Atrovent Synthroid;	chronic COPD	PCN, Hyperthyriadism, Hyperlipidemia;	~ ()~~~In patient		1						1	Oedema peripheral	FLU3~PFIZER\WYETH~361927~1~IM~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0056854	11/30/1993	MO	60.0	60		M	11/30/1993	GBS 2.5 wks p/vax;req ventilation and ICU care;had 6 plasmapheresis tx, did well, then relapsed & now recv plasmapheresis			Y		Y				N	10/05/1993	10/19/1993	14	neurologic exam; LP; nl blood tests	OTH	PVT	none	none	none	none~ ()~~~In patient		1						2	Dysgeusia; Dysphagia; Dyspnoea; Guillain-Barre syndrome; Myasthenic syndrome; Paraesthesia; Paralysis; Paralysis flaccid; Guillain-Barre syndrome; Respiratory disorder	FLUX~PFIZER\WYETH~4938254~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation	Influenza
0057339	11/30/1993	FL	54.0	54		F	11/18/1993	pt recvd vax 23SEP93 & was adm to hosp 29OCT93 w/bilateral leg weakness, CSF elevated protein; dx GBS; hosp course complicated by yeast infect;					Y			Y		09/23/1993	10/07/1993	14	CSF mylin protein <10 neg oligocloal bard protein 76 mg% w/o cells; CMV coxsackie, echo titers-neg;	UNK	UNK	Aldomet, Dyerzide for HTN		HTN	~ ()~~~In patient		1						2	Asthenia; Back pain; Guillain-Barre syndrome; Hypokinesia; Pain; CSF test abnormal; Guillain-Barre syndrome; Infection; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~3F41122~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~3F41122~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation,Disabling	Influenza
0057530	11/30/1993	MA	85.0	85		M	11/10/1993	GBS 25 yrs ago usual state of hlth until 2 wks ago; 4 days prior to admission on 26OCT devel paresthesis toes, feet, fingers now w/progressive paresthesis intubated on a vent;					Y		Y			10/04/1993	10/22/1993	18		PVT	PVT		NONE		NONE~ ()~~~In patient		1						2	Guillain-Barre syndrome; Paraesthesia; Respiratory disorder; Gait disturbance; Guillain-Barre syndrome; Myasthenic syndrome; Nausea; Paraesthesia; Respiratory disorder; Vomiting	FLUX~PFIZER\WYETH~4938144~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938144~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLUX~PFIZER\WYETH~4938144~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Hospitalisation	Influenza
0057794	11/30/1993	MD	68.0			U	11/30/1993	GBS approx 5 wks p/flu vax;										10/22/1993	11/05/1993	14		UNK	UNK				~ ()~~~In patient		1						1	Guillain-Barre syndrome; Neuropathy	FLU3~PARKE-DAVIS~01293P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057803	11/30/1993	NH	46.0	46		F	11/18/1993	h/a, nausea, chills, sweating, achy, dizzy, sore arm;										11/17/1993	11/17/1993	0		PVT	PVT			asthma	~ ()~~~In patient	NH93026	1						1	Chills; Dizziness; Headache; Hyperhidrosis; Myalgia; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057809	11/30/1993	MT	81.0			M		pt recvd flu vax & exp weakness, could not walk;					Y					10/09/1993	10/10/1993	1		UNK	UNK	Pergolide, Sinonet; APAP		long hx parkinson's disease, NIDDM	~ ()~~~In patient		1						1	Asthenia; Condition aggravated; Hypokinesia; Neuropathy	FLUX~PFIZER\WYETH~4938148~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0057811	11/30/1993	MI	46.0	46		F	11/22/1993	5 minutes p/inject devel pruritus; progressed to urticarial react; treated @ ER w/DPH;				Y					Y	10/06/1993	10/06/1993	0	NONE	PVT	UNK		URI- 7-10 days prior		~ ()~~~In patient		1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0057819	11/30/1993	ME	48.0	48		F	11/25/1993	rt arm pain & numbness beginning 3 days p/vax; dx by neurologist brachial plexus neuropathy;				Y					N	10/13/1993	10/16/1993	3	EMG	MIL	MIL	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Neuropathy; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~3J41019~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0057821	11/30/1993	MA	61.0	61		F	11/22/1993	pain in knee joints;									N	10/30/1993	10/31/1993	1		PUB	PUB			multiple sclerosis (MS)	~ ()~~~In patient	MA9369	1						1	Arthralgia	FLUX~PFIZER\WYETH~4938083~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057826	11/30/1993	ME	43.0			F		hx of genital herpes; pt recvd flu vax & precipitated an outbreak;									Y	10/19/1993	10/22/1993	3	pt hx	MIL	MIL	Elavil	NONE	Herpes	NONE~ ()~~~In patient		1						1	Condition aggravated	FLU3~CONNAUGHT LABORATORIES~3J41019~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057828	11/30/1993	OH	4.0	4		M	11/22/1993	pt w/developmental delay, speech delay & past hx of Henoch-Schonlein purpura APR91 recvd vax 6OCT; mom reported purpura lesions;									Y	10/06/1993	10/06/1993	0	NONE	PVT	PVT	Hydricortisone; Lubrederm;		developmental delay, speech delay & henoch-Schonlein purpura APR91;	~ ()~~~In patient		1						1	Purpura	FLUX~PFIZER\WYETH~4938142~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057829	11/30/1993	RI	34.0	34		F	11/23/1993	pt recvd vax 12OCT93 & reported that evening exp sx including numbness to inner upper lip, itching to palate, sensation of pins & needles on tongue & fever to 101; took APAP;									Y	10/12/1993	10/12/1993	0	NONE	PUB	OTH	NONE	NONE	erythromycin (GI distrubance);	NONE~ ()~~~In patient		1						1	Paraesthesia oral; Pruritus; Pyrexia	FLU3~PARKE-DAVIS~~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057830	11/30/1993	NY	52.0	52		F	11/15/1993	pt states that rt arm started hurting; nodule appeared below the inject site; pain responded over past six wks to NSAID's but has remained intermittent when using the arm in certain positions;									N	10/02/1993	10/02/1993	0	WBC 8.1; CPK 91;	PVT	PVT	Premarin	NONE	NONE	~ ()~~~In patient		1						1	Blood creatine phosphokinase increased; Injection site mass; Pain	FLU3~PFIZER\WYETH~361923~UNK~IM~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0057833	12/01/1993	IL	60.0			F	11/19/1993	renal failure & post infect glomerulonephritis exp by pt who recvd flu vax;					Y	20			U	10/01/1993	10/14/1993	13		OTH	OTH	cardizem, premarin, zantac;		bee sting allergy	~ ()~~~In patient	27697	1						1	Albuminuria; Blood urea increased; Creatinine renal clearance decreased; Glomerulonephritis; Renal failure; Urine analysis abnormal	FLU3~PARKE-DAVIS~01063P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0057796	12/02/1993	WI	55.0	55		F	11/24/1993	Pt began developing numbness in feet, problem progressed to increased weakness, decreased sensation lower half of body; eventual paralysis; diagnosed w/GBS on 21NOV93;				Y	Y		Y		U	10/28/1993	11/10/1993	13	Uncertain as to the exact diagnostic tests etc;	OTH	PVT	Unknown;		Hx of diabetes;	~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome; Paraesthesia; Paralysis	FLUX~PFIZER\WYETH~4938152~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0057797	12/02/1993	WA	54.0	54		F	11/23/1993	Severe upper back pain, worsened w/radiating to rt breast; p/5 days weakness to all extremities; MD suspects GBS; IVIG ?- not given; pt to another hosp; w/in 3-4 days of vax, URI which resolved; later distal paresthesias, SOB, intubated;			Y	Y	Y	9	Y			10/26/1993	11/03/1993	8	CSF showed inc protein, no WBC's; CFS test--no results;	PUB	PUB		N/a	No allergies;	~ ()~~~In patient	WA93980	1						1	Asthenia; Back pain; Breast pain; CSF test abnormal; Dyspnoea; Guillain-Barre syndrome; Paraesthesia; Pharyngitis	FLUX~PFIZER\WYETH~4938226~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~356964~UNK~~RA~PNEUMO (PNU-IMUNE)~1	USA	Life Threatening,Hospitalisation	Influenza
0057798	12/02/1993	FL	19.0	19		M	11/23/1993	Pt recvd routine initial battery of vaxs for recruits; on 12NOV93 devel leg weakness which quickly progressed to point of being unable to stand; arms also became weakened; was hosp & plasmapheresed; condition improved greatly; dx: GBS;				Y	Y				Y	11/05/1993	11/12/1993	7	CSF was negative; tox screen, heavy metal screen, electrolytes: neg;	MIL	MIL		URI/sore throat 2 weeks prior to onset;	NONE	~ ()~~~In patient		1						1	Guillain-Barre syndrome; Myasthenic syndrome	ADEN~PFIZER\WYETH~4928172~UNK~PO~MO~ADENOVIRUS (TYPE 4, NO BRAND NAME)~1|ADEN~PFIZER\WYETH~4928174~UNK~PO~MO~ADENOVIRUS (TYPE 7, NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~3J41143~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~CONNAUGHT LABORATORIES~3C51059~UNK~IM~~MENINGOCOCCAL (MENOMUNE)~1|MMR~MERCK & CO. INC.~0896W~UNK~IM~~MEASLES + MUMPS + RUBELLA (MMR II)~1|OPV~PFIZER\WYETH~0677M~UNK~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~1	USA	Hospitalisation	Influenza
0057839	12/02/1993	WA	44.0	44		M	09/27/1993	vertigo/oscillopsia p/vax; ?demyelinating;									N	10/05/1992	10/12/1992	7	MRI/neuro eval; vertigo non specific MRI; pos curtral;	MIL	MIL	NONE	NONE	transcient nercroses since 85; (tinnitus, migraine);	~ ()~~~In patient	WA93963	1						1	Neuropathy; Vertigo	FLU3~CONNAUGHT LABORATORIES~4928206~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057849	12/02/1993	WA	49.0	49		M	10/27/1993	onset flu type sx 6 hrs p/vax; t104+; reddness & soreness remain @ inject site; MD seen 25OCT93;				Y					Y	10/22/1993	10/22/1993	0		PUB	PUB	Dilantin	NONE	NONE	~ ()~~~In patient	WA93974	1						1	Influenza; Injection site hypersensitivity; Injection site pain; Pyrexia	FLUX~PFIZER\WYETH~4938145~6~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~340939~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0057850	12/02/1993	WA	18.0	18		F	10/25/1993	p/5mins post inject c/o burning in inject site, ice applied; a few minutes later c/o dizziness, was responding but c/o feeling bad; walked to car & got in, was not able to get out @ hosp;					Y	3			Y	10/17/1993	10/17/1993	0		OTH	PVT	NONE	NONE	no allergies	pt's sibling exp rash w/aches @ 18 mos w/flu shot 1987;~ ()~~~In Sibling	WA93975	1						1	Convulsion; Dizziness; Injection site pain; Malaise	FLU3~PARKE-DAVIS~~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0057852	12/02/1993	WA	44.0	44		F	11/05/1993	immed p/vax pt c/o severe pain in lt arm (shoulder to fingers tips); c/o dizziness; pt placed on floor; did not lose consciousness; exp weakness;									U	11/04/1993	11/04/1993	0		PUB	PUB	NONE	No illness	NONE	~ ()~~~In patient	WA93978	1						1	Asthenia; Dizziness; Pain	FLUX~PFIZER\WYETH~4938145~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057855	12/02/1993	NC	82.0	82		F	11/26/1993	10 days p/flu vax devel occular myasthenia gravis documented by pos edrophonium & pos anti acetylcholine antibiotic test; also began treatment for parkinson disease;								Y		10/07/1993	10/17/1993	10	pos edrophorinum 28OCT93; antiacetylchloline antibiotic test 28OCT93;	UNK	UNK	NONE		early Parkinson; mild inhalent allergies; s/p 2 1/2 yrs partial colectomy for adenocarcinoma odor;	~ ()~~~In patient		1						1	Laboratory test abnormal; Myasthenic syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0057857	12/02/1993	MD	31.0	31		F	11/21/1993	pt recvd flu shot 22OCT93; 28OCT93 unable to move due to pain in neck, shoulder, behind eyes progressing to arms & legs; 5NOV93 unable to eat w/o dropping food, arms were like noodles; began w/resp problems, like an asthma attack;				Y					U	10/22/1993	10/28/1993	6	x-rays of spine; refused blood work;	PUB	PUB	Allupent, Sedlane, Beconase	NONE	asthma; hx of cat dander allergy; ? mold spores allergy; hayfever;	~ ()~~~In patient	MD93059	1						1	Asthma; Hypokinesia; Muscle atrophy; Neck pain; Pain; Respiratory disorder	FLU3~PARKE-DAVIS~00963P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0057859	12/02/1993	TX	72.0	72		M	11/24/1993	pt devel rash (red splotches) over trunk & limbs; no SOB noted but lips became swollen; urticaria;									Y	11/13/1993	11/13/1993	0	NONE	PUB	PUB	unk	NONE	cardiac	~ ()~~~In patient		1						1	Face oedema; Rash maculo-papular; Urticaria	FLU3~CONNAUGHT LABORATORIES~3F41009~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057863	12/02/1993	NH	65.0	65		M	11/18/1993	severe flu sx in pain throughout whole body; fever, did not eat for 2 days; slept most of 2 days-still tired; did not see MD;									Y	10/21/1993	11/12/1993	22	NONE	PUB	PUB				~ ()~~~In patient		1						1	Anorexia; Asthenia; Influenza; Pain; Pyrexia; Somnolence	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057864	12/02/1993	NY	92.0	92		F	10/14/1993	pt became very diaphoretic & was found unresponsive; BP 80/40;									Y	10/14/1993	10/14/1993	0		PVT	PVT	Prinavil, Procardia XL, Lasix, Nitro (PRN), Isobide;	hypertension	hypertension, breast CA, Osteoperosis, Raynaudes;	NA~ ()~~~In patient		1						1	Hyperhidrosis; Hypotension; Stupor	FLU3~CONNAUGHT LABORATORIES~3F41122~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0061457	12/02/1993	NJ	48.0	48		F		Pt recvd vax & devel h/a, felt weak & tired; 19DEC92 devel corneal ulcers which persisted; consulted a physician 1 wk prior to christmas who sent pt to an ophthalmologist w/c/o scalp tenderness which began on 30Jan93;also exp pins & needles				Y					Y	11/05/1992				PVT	PVT			allergy, PCN;		WAES93020355	1						1	Asthenia; Dermatitis bullous; Herpes simplex; Herpes zoster; Pain; Paraesthesia; Ulcerative keratitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057774	12/03/1993	MI	55.0	55		F	11/21/1993	GUILLAIN BARRE SYNDROME.  PT STARTED FEELING WEAK ABOUT 3-5 DAYS PRIOR TO ADMISSION			Y		Y	14			U	10/15/1993	11/05/1993	21		PVT	UNK		NONE	COPD	~ ()~~~In patient		1						2	Guillain-Barre syndrome; Respiratory disorder; Asthenia; Guillain-Barre syndrome	FLUX~PFIZER\WYETH~4938181~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938181~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation	Influenza
0057776	12/03/1993	MI				F		GUILLAIN BARRE SYNDROME				Y					Y	10/18/1993	10/28/1993	10	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						2	Guillain-Barre syndrome; Paraesthesia; Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~3F41141~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~3F41141~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0057873	12/03/1993	OH	78.0	78		M	11/21/1993	intermittent-99-100 onset 21NOV93; lower legs red & sore to touch, hot touch, h/a 2-3 days not responsive to pain killers; knee joint pain, weakness noc sweat;				Y					Y	11/03/1993	11/21/1993	18		PUB	PUB		NONE		NA~ ()~~~In patient		1						1	Arthralgia; Asthenia; Headache; Hyperhidrosis; Pain; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41008~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0057874	12/03/1993	WI	71.0	71		M	11/29/1993	20NOV93 rash noted; 21NOV93 seen @ ER for sever itching urticaria rash extremities, trunk, neck; DPh;				Y					Y	11/19/1993	11/20/1993	1	NONE	PVT	PVT	NONE	NONE	s/p colon CA resection 1990; Hodgkins Disease 1958-in remission;	~ ()~~~In patient		1						1	Pruritus; Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~2253HA~3~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057880	12/03/1993	CA	71.0	71		F	11/18/1993	pt woke p/noc sleep; went into bathroom had diarrhea; became very weak, diaphoretic, dizzy; once back in bed, had nausea w/vomiting; devel a severe h/a & lumbar back pain immed; APAP for h/a & low grade fever 98.8;									Y	11/03/1993	11/04/1993	1	NONE	OTH	OTH		NONE	hypothyroidism, post CVA 1988 lt sided weakness, DJD;	NONE~ ()~~~In patient		1						1	Asthenia; Back pain; Diarrhoea; Dizziness; Headache; Hyperhidrosis; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~3F41032~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057881	12/03/1993	MD				U		flu shot 3PM lt deltoid & 312PM pt c/o difficulty swallowing & tightness p/flu shot; voice sounds hoarse; pt states feels itchy; 315PM given DPH; face flushed & pt thirsty;									Y	11/10/1993	11/10/1993	0		PUB	OTH		unk	unk	~ ()~~~In patient		1						1	Dysphagia; Dysphonia; Pruritus; Thirst; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41122~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057882	12/06/1993	TN	40.0	39		M	11/22/1993	transverse myelitis or GBS MD stated sx started 18NOV @ noon; progressive numbing from feet to chest stopped @ sternum adm to hosp 4PM 18NOV93;					Y				U	10/20/1993	11/18/1993	29	MRI Scan, LP, U/A, Blood work (heavy metal);	PUB	PUB		NONE		~ ()~~~In patient	TN93121	1						1	Back pain; Guillain-Barre syndrome; Myelitis; Paraesthesia	FLUX~PFIZER\WYETH~4938262~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0057883	12/06/1993	MS	30.0	30		M	11/22/1993	26 hrs p/inject exp numbness & tingling in hands & feet & difficulty walking; wk of 7NOV had pain in legs, hand & feet-difficult going up steps; 22NOV states having difficulty keeping balance; lost 14lbs, difficulty swallowing; poss virus;				Y					N	11/04/1993	11/05/1993	1	15NOV93 dx w/GBS	PUB	PUB	NONE	NONE	NONE	NA~ ()~~~In patient	MS93053	1						1	Coordination abnormal; Dysphagia; Gait disturbance; Guillain-Barre syndrome; Infection; Pain; Paraesthesia; Weight decreased	FLUX~PFIZER\WYETH~493158~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057884	12/06/1993	MA	64.0			M	11/30/1993	Pt recvd vax & exp fever, chills, myalgia & diarrhea, next day exp diarrhea, incontinent & to weak to get out of bed; exp lt leg swelling, edema, cellulitis; pt was adm; MD felt poss GBS; also erythema, flu sx, gouty podagra; pt flushed;					Y	7			Y				t101.8 falling to 98.6; BP 102/64 rising to 140/80, pulse 120 falling to 80, resp 20; neuro-bilat paraparesis w/leg weakness, w/flaccid dec in tone, areflexic; lt atrial enlargement, rare PVC, WBC count 15,500, LDH w/cellulitis 677; CPK 183	MIL	UNK				~ ()~~~In patient		1						1	Blood lactate dehydrogenase increased; Cardiomegaly; Guillain-Barre syndrome; Hypotension; Influenza; Leukocytosis; Myositis; Oedema peripheral; Ventricular extrasystoles	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0057885	12/06/1993	GA	42.0	42		F	12/02/1993	15NOV93 onset of intermittent fever (to 103), nausea/diarrhea, chest pain, dizziness, fatigue, numbness extremities, numbness of face on 19NOV93 myalgia; 21NOV93 lt sided weakness, absent deep tendon reflexes;			Y	Y	Y	17	Y		U	11/04/1993	11/14/1993	10	CSF on 21NOV nl pressure, WBC 2, Glucose 56, protein 240;	PVT	PUB	Stenolol	NONE	NONE x/mitral valve prolapse;	~ ()~~~In patient		1						1	Chest pain; Diarrhoea; Dizziness; Guillain-Barre syndrome; Hyporeflexia; Myalgia; Paraesthesia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41035~3~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0057890	12/06/1993	ME				U	12/02/1993	Herpes labialis exacerbation in pt;					Y				U					MIL	MIL				~ ()~~~In patient	CO5126	1						1	Condition aggravated	FLU3~CONNAUGHT LABORATORIES~3J41019~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0057891	12/06/1993	HI	51.0	51		M	09/27/1993	pt recvd vax & 4 hrs later devel dizziness & diaphoresis; pt was admitted to hosp w/dx of sinus bradycardia;				Y	Y	5			Y	09/21/1993	09/21/1993	0		PUB	PUB	NONE	NONE		~ ()~~~In patient	893300015C	1						1	Dizziness; Hyperhidrosis; Sinus bradycardia	FLUX~PFIZER\WYETH~4938137~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0057895	12/06/1993	IA	77.0	77		F	10/15/1993	disequilibrium w/ambulation; ataxia; ataxia improved overnoc; sl lean to lt remained adm to hosp for tests & observation on bedrest;				Y	Y	3			Y	10/08/1993	10/10/1993	2	Neg MRI; EKG-UA-CBC-CXR-Blood glucose all neg;	PUB	UNK	Diabeta;	NONE	allergic to PCN-type II OM-fallen bladder-frequent UTI;	~ ()~~~In patient	IA93031	1						1	Coordination abnormal	FLU3~PARKE-DAVIS~00863P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0057897	12/06/1993	MA	76.0	76		F	11/24/1993	1 minute p/vax pt collapsed w/twitching movement of lower extremities, non responsive to verbal or physical stimuli w/in minutes; w/in minutes was alert, vague, sitting upright; no visible s/s injury;									Y	10/21/1993	10/21/1993	0	NA	OTH	PUB	Dilantin	no acute illness	epilepsy	~ ()~~~In patient	MA9367	1						1	Condition aggravated; Muscle twitching; Stupor; Syncope	FLUX~PFIZER\WYETH~4938083~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057917	12/06/1993	MI	7.0			F	10/07/1993	mom reports pt recvd vax 6OCT93 1030AM; w/in 1-2 hrs pt appeared to wheeze, cough & stated throat felt tight; pt is an asthmatic but has never had tightening of throat a/;									Y	10/06/1993	10/06/1993	0	NONE	PUB	PUB	Defridil	NONE	asthma	~ ()~~~In patient	MI93143	1						1	Asthma; Cough; Laryngospasm	FLUX~PFIZER\WYETH~4938142~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057918	12/06/1993	MI	18.0	18		F	10/11/1993	immed pt exp a metalic taste in mouth; c/o feeling faint, exp shaking diaphoresis (profuse sweating); pt was taken to hosp ER; BP dropped; pt was dx as experiencing a vaso vagal reaction; observed for 2 1/2 hrs; & released;				Y					Y	10/06/1993	10/06/1993	0	NONE	PUB	PUB	Seldane; Minocin;	allergies to environmental allergies;	slight asthma; allergy to environmental factors, acne;	NONE~ ()~~~In patient	MI93144	1						1	Dizziness; Dysgeusia; Hyperhidrosis; Hypotension; Syncope; Tremor	FLUX~PFIZER\WYETH~4938142~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057921	12/06/1993	MI	72.0	72		M	10/12/1993	5OCT93PM chills, muscle aches, fatigue, loss appetite, h/a, sore throat; flu-like sx lasted 7 days;									Y	10/04/1993	10/05/1993	1	NONE	PUB	PUB	APAP	NONE	NONE	~ ()~~~In patient	MI93147	1						1	Anorexia; Asthenia; Chills; Headache; Influenza; Myalgia; Pharyngitis	FLUX~PFIZER\WYETH~4938147~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057925	12/06/1993	MI	62.0	62		M	10/20/1993	Pt started coughing, felt like something in nasal passage; blood spots in mouth, gums numb; MD states allergic rxn to flu vax; upper lip swollen & numb;				Y						10/14/1993	10/14/1993	0		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MI93151	1						1	Cough; Face oedema; Hypersensitivity; Mucous membrane disorder; Paraesthesia oral	FLUX~PFIZER\WYETH~4938142~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057927	12/06/1993	MI	62.0	62		M	10/28/1993	extreme hives 3 days p/inject;				Y					Y	10/21/1993	10/24/1993	3	NONE	PUB	PUB	Puton, Medral;	NONE	NONE	NONE~ ()~~~In patient	MI93153	1						1	Urticaria	FLUX~PFIZER\WYETH~4938147~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~356965~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0057930	12/06/1993	MI	7.0	7		F	10/27/1993	pt recvd vax 25OCT93 sl pink area rt upper arm; 27OCT93 swelling & redness elbow to shoulder, raised red splotches upper rt arm; APAP given;				Y					Y	10/25/1993	10/26/1993	1		PUB	UNK		NONE	asthma	~ ()~~~In patient	MI93156	1						1	Injection site hypersensitivity; Injection site oedema; Rash maculo-papular	FLUX~PFIZER\WYETH~4938142~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~360960~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0057931	12/06/1993	MI	65.0	65		M	11/01/1993	27OCT93 c/o soreness day of shots; 29OCT93 c/o swelling lt arm; 1NOV93 sore lt shoulder & hard to lift lt arm above head;				Y					N	10/27/1993	10/28/1993	1		PUB	PUB		NONE	1992 operation on back of neck for spinal fluid collecting in brain (Shunt);	~ ()~~~In patient	MI93157	1						1	Hypokinesia; Myalgia; Oedema	FLUX~PFIZER\WYETH~4938142~3~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0093W~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0057933	12/06/1993	MI	70.0	70		F	11/02/1993	pt had red hard area @ site of flu inject; fatigue, diarrhea, upset stomach; electrolytes off, weakness, low body temp, shivering;					Y	3			Y	10/04/1993	10/05/1993	1		PUB	UNK	Procardia, Estorgen;	NONE	NONE	~ ()~~~In patient	MI93159	1						1	Asthenia; Chills; Diarrhoea; Dyspepsia; Electrolyte imbalance; Hypothermia; Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~3F41142~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~334958~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0057939	12/06/1993	MI	37.0	37		F	11/18/1993	16NOV Am c/o chills, fever, coughing up phelm, achyness; worsened during day; 17NOV cont as above; spent day in bed; 18NOV feeling better; back @ work;									Y	11/15/1993	11/16/1993	1	NONE	PUB	PUB				~ ()~~~In patient	MI93165	1						1	Chills; Cough; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~4938178~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057940	12/06/1993	MI	28.0	28		F	11/01/1993	pt recvd flu vax 26OCT93; lump in lt axilla 2 days later w/fluid; more painful now w/pain down arm & fingers;				Y					Y	10/26/1993	10/28/1993	2	Blood tests all nl;	PUB	PUB	Hismanal	NONE	dust, animals, pollen; allergy to keflex, PCN, Sulfa;	~ ()~~~In patient	MI93166	1						1	Pain; Skin nodule	FLU3~CONNAUGHT LABORATORIES~3F41033~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0057942	12/06/1993	MN	48.0	48		F	11/08/1993	sensation of edema in legs & aching in both knees & metatarsals were initial s/s; edema did devel in knees & thighs;									Y	10/27/1993	11/03/1993	7	NONE	PUB	PUB	NONE	NONE	arthritis-spine	~ ()~~~In patient	MN93054	1						1	Arthralgia; Oedema peripheral; Osteoarthritis	FLUX~PFIZER\WYETH~4938142~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057943	12/06/1993	MN	76.0	76		F	11/05/1993	nausea & vomiting w/generalized h/a, malaise, fatigue developing w/in 24 hrs p/vax & tapering off;									Y	10/28/1993	10/29/1993	1		PVT	PVT				~ ()~~~In patient	MN93056	1						1	Asthenia; Headache; Malaise; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~E2253HA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057945	12/06/1993	MN	41.0	41		F	10/16/1993	c/o dizziness, became pale, diaphoretic, nauseated: p=12--no discernable BP 15 mins p/shot administered; givenEpi & BP & pulse returned to nl p/45 mins;									Y	10/16/1993	10/16/1993	0		PUB	PUB	Thyroid	NONE	previous react to swine flu vax;	pt exp dizzy w/swine flu;~ ()~~~In patient	MN93058	1						1	Dizziness; Hyperhidrosis; Hypotension; Nausea; Pallor; Tachycardia	FLU3~CONNAUGHT LABORATORIES~3F41114~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057946	12/06/1993	MN	50.0	50		F	10/04/1993	tenderness & swelling of site of inject;									Y	09/27/1993	09/28/1993	1	NONE	PUB	PUB		NONE	allergy to PCN, sulfa, dentures, cartirone, ASA;	~ ()~~~In patient	MN93059	1						1	Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~4938141~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057947	12/06/1993	MN	25.0	25		F		had chills 7 hrs p/flu shot; was shaky lasting until the next morning;									Y	10/04/1993	10/04/1993	0		PUB	PUB		NONE		~ ()~~~In patient	MN93060	1						1	Chills; Tremor	FLUX~PFIZER\WYETH~4938141~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057950	12/06/1993	MN	64.0	63		F	10/15/1993	14OCT93 vax administered; 5:00 numbness in arm; 7:00 acute onset of SOB & bronchiospasms; treated w/IV steroids; hospitalized;				Y	Y				Y	10/14/1993	10/14/1993	0		PVT	UNK		NONE	heavysmoker, chemically dependent, macidcytosis;	~ ()~~~In patient	MN93063	1						1	Asthma; Dyspnoea; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~3S41152~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0057951	12/06/1993	MN	72.0	72		F	10/15/1993	pt recvd vax & 6OCT93 AM when got out of bed-dizzy, room spinning; this cont x 1 wk; occasional upset stomach; 12OCT93 inc dizzy, vomiting, dehydrated; 13OCT93 hospitalized; did not have any fever, nor muscle aches, bone aches; inner ear					Y	2			Y	10/05/1993	10/06/1993	1	routine blood & urine tests;	PUB	PUB	Vasoretic-BP pill for 8 years;	NONE	allergy;Sulfa; Hypertension;	NONE~ ()~~~In patient	MN93064	1						1	Dehydration; Dizziness; Dyspepsia; Infection; Vomiting	FLUX~PFIZER\WYETH~4938086~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0057952	12/06/1993	MN	64.0	64		M	11/10/1993	pt recvd vax & devel chills, high fever all noc; sweat, arm very sore & next day very reddened & swollen; hives; MD recommended DPH for itching; hives pt's temp was up & down;									Y	10/19/1993	10/19/1993	0	NONE	PUB	PUB	NONE	NONE	NONE (allergy to sulfa in 1940's);	~ ()~~~In patient	MN93065	1						1	Chills; Hyperhidrosis; Myalgia; Oedema peripheral; Pruritus; Pyrexia; Urticaria; Vasodilatation	FLUX~PFIZER\WYETH~4938169~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1042V~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0057953	12/06/1993	MO	43.0	43		M	11/24/1993	pt recvd vax 15NOV93 & 17NOV93 about 1 hr p/receiving TB skin test; sx started w/severe back pain, generalized aching, h/a, nausea; lasted 4 days;									Y	11/15/1993	11/17/1993	2	positive TB skin test on 19NOV93;	PUB	PUB	Methadone	denies	In methadone program for relief of pain;	~ ()~~~In patient	MO93118	1						1	Back pain; Headache; Myalgia; Nausea	FLU3~CONNAUGHT LABORATORIES~3741123~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057954	12/06/1993	MO	71.0	71		F	11/24/1993	16NOV93 nauseated & vomited [[name]] fluids & had diarrhea-[[name]] in color; 17NOV93 sl diarrhea [[name]]/brown 23NOV93 clear all sx;									Y	11/09/1993	11/16/1993	7	NONE	PUB	PUB	Zolft (antidepr); Zocor for cholesterol; Daypro for pain (arthritis);	NONE	PCN/codiene allergies; arthritis, the chol, deprepsin, obesity;	NONE~ ()~~~In patient	MO93119	1						1	Diarrhoea; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~3F41123~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057956	12/06/1993	MS	52.0	52		F	10/27/1993	rt arm area-red raised area 2 inches in diameter-warm;									Y	10/20/1993	10/20/1993	0		PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient	MS93051	1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLUX~PFIZER\WYETH~493168~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~334957~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0057957	12/06/1993	MS	62.0	61		F	11/18/1993	dizzy headed a/getting home; aching profuse sweating; loss of appetite; has pump device for pain in back; sore throat, headache;									N	11/15/1993	11/15/1993	0	NA	PUB	PUB	soma-sleeping pills;	NONE	codeine & PCN; chronic back problems;	~ ()~~~In patient	MS93052	1						1	Anorexia; Dizziness; Headache; Hyperhidrosis; Myalgia; Pharyngitis	FLUX~PFIZER\WYETH~3F41029~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057962	12/06/1993	SC	56.0	55		F	11/02/1993	pt c/o of pain in lt ear on 21OCT93; 23OCT93 AM upon waking, pt's lt eye would not close & lt side of mouth drawn; some paralysis/weakness; dx w/bell's Palsy;				Y						10/21/1993	10/23/1993	2		PUB	PUB				~ ()~~~In patient	SC93134	1						1	Ear pain; Facial palsy; Myasthenic syndrome	FLUX~PFIZER\WYETH~4938138~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057966	12/06/1993	SC	18.0	18		M	11/16/1993	pt recvd flu vax on 1NOV93; reports approx 2 days p/inject noticed a skin rash on arms, hands; itching occassionally; also reported a couple episodes of a quick gasp for breath;									Y	11/01/1993	11/03/1993	2	NA	PUB	UNK	denies	NA		~ ()~~~In patient	SC93138	1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~3F41124~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057967	12/06/1993	SC	3.0	3		M	11/19/1993	fine papular rash consistant w/viral or drug rash w/instructions to use DPh; MD wasnts info on chart that pt is allergic to flu vax;				Y					Y	11/16/1993	11/17/1993	1	CBC done in MD office-results WNL:	PUB	PUB		NONE	NONE	~ ()~~~In patient	SC93139	1						1	Hypersensitivity; Infection; Rash maculo-papular	FLUX~PFIZER\WYETH~3F41007~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057972	12/06/1993	TN	56.0	56		F	11/05/1993	tenderness @ site of inject, elevated temp, aching all over, h/a for 1 wk, seen by MD, was put on symmetril missed 4 1/2 days work;				Y					Y	10/19/1993	10/20/1993	1	NONE	PUB	PUB	for arthritis & allerges;	NONE	mold	~ ()~~~In patient	TN93114	1						1	Headache; Injection site pain; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~4938181~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057973	12/06/1993	TN	69.0	69		F	11/08/1993	31OCT93 devel chills, fever (temp not ck'd), vomiting, diarrhea, generalized weakness; seen by MD 1NOV93, was told sx due to allergies; sx lasted 1 wk;				Y					Y	10/22/1993	10/31/1993	9	NONE	PUB	PUB	Mevacor, Procardia, Diazide, Hormone;	NONE	heart problem, many allergies;	~ ()~~~In patient	TN93115	1						1	Asthenia; Chills; Diarrhoea; Pyrexia; Vomiting	FLUX~PFIZER\WYETH~4938181~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057975	12/06/1993	TN	65.0	65		M	11/15/1993	sore throat, hoarseness, h/a, t99-101; seen by MD was told URI; sx lasted 7 days;				Y					Y	10/20/1993	10/25/1993	5	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	TN93117	1						1	Dysphonia; Headache; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4938181~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0057977	12/06/1993	TN	33.0	33		F	11/16/1993	severe ache, chills, fever low grade fever 4 days; back sore to touch;										11/11/1993	11/12/1993	1		PUB	PUB				~ ()~~~In patient	TN93119	1						1	Back pain; Chills; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~4938138~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057978	12/06/1993	TN	77.0	77		F	11/18/1993	blood pressure up, kidney infect, urinary tract infect, nauseated, bad chills;				Y						11/03/1993	11/12/1993	9		PUB	PUB				~ ()~~~In patient	TN93120	1						1	Chills; Hypertension; Nausea; Urinary tract infection	FLUX~PFIZER\WYETH~4938783~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057979	12/06/1993	TN	50.0	50		F	11/22/1993	flu sx, aching, fever, congestion;				Y						11/12/1993	11/15/1993	3		PUB	PUB				~ ()~~~In patient	TN93122	1						1	Influenza; Myalgia; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~4938183~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057980	12/06/1993	TN	70.0	70		F	11/29/1993	w/in 2 minutes p/shot had odd feeling hard to explain feeling; 21OCT93 had sight problems, bright spots and blacks-felt faint, high blood pressure @ ER;				Y						10/19/1993	10/19/1993	0		PUB	PUB				~ ()~~~In patient	TN93123	1						1	Hypertension; Syncope; Visual disturbance	FLUX~PFIZER\WYETH~4938261~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057981	12/06/1993	TN	41.0	41		F	11/30/1993	sore throat 6 days p/shot x 2 days; fever 101.3 x 3 days; URI x 2 days;				Y					Y	10/27/1993	11/02/1993	6	NA	PVT	PVT	NA	NA	NA	~ ()~~~In patient	TN93124	1						1	Pharyngitis; Pyrexia	FLUX~PFIZER\WYETH~4938164~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057982	12/06/1993	TN	42.0	42		F	12/01/1993	8 days sick w/flu like sx;				Y						10/26/1993	11/21/1993	26		OTH	PUB				~ ()~~~In patient	TN93125	1						1	Influenza	FLUX~PFIZER\WYETH~4938183~5~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057983	12/06/1993	TX	83.0	83		M	10/27/1993	feeling bad, congestion in lungs, coughing, sweating, inc temp achy bone in arms & legs;										10/21/1993	10/21/1993	0		PUB	PVT	NONE			~ ()~~~In patient	TX93200	1						1	Bone pain; Cough; Hyperhidrosis; Lung disorder; Malaise; Pyrexia	FLU3~PARKE-DAVIS~00573P~2~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057987	12/06/1993	TX	87.0	87		F	10/29/1993	hives to arms, legs accompanied by itching;									Y	10/20/1993	10/21/1993	1		PUB	OTH		NONE	THyroid pill for 20 yrs;	~ ()~~~In patient	TX93205	1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~3F41009~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057990	12/06/1993	TX	58.0	58		M	11/16/1993	c/o 3 days of wheezing & severe h/a commencing 14OCT93; went to ER 17OCT93; dx bacterial pneumonia; tx Biaxin;				Y					Y	09/21/1993	11/14/1993	54	CXR, UA, CaRdiac enzymes, CBC, results not available;	PUB	PUB		NONE	NKA	~ ()~~~In patient	TX93208	1						1	Asthma; Drug ineffective; Headache; Infection; Pneumonia	FLU3~CONNAUGHT LABORATORIES~3F41009~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~336942~1~IM~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0057996	12/06/1993	TX	62.0	62		F	11/17/1993	12NOV93 pt recvd vax & 13NOV93 awoke 6AM w/h/a, not feeling well on Sunday t101 & devel a red raised whelp below the inject site;-painful;				Y					Y	11/12/1993	11/13/1993	1	NONE	PUB	PUB	NONE	NONE	Pcn & sulfa-last lung CA TA-18 months ago	NONE~ ()~~~In patient	TX93214	1						1	Headache; Injection site hypersensitivity; Injection site mass; Malaise; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41009~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0058002	12/06/1993	TX	61.0	60		F	11/03/1993	redness & edema @ site of inject-2NOV93 pain @ time of inject till Monday 1NOV93; Friday noc rt side of face not sensitive as lt side; rt hand tingles, feels week;										10/28/1993	11/01/1993	4		PUB	PUB	Lozal, Provera; Insulin, Premarin;	NONE	diabetic, inc BP;	NONE~ ()~~~In patient	TX93220	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Myasthenic syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~3F41009~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~356967~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0058003	12/06/1993	VA	59.0	59		F	11/15/1993	pt recvd vax & c/o goose egg lt arm site of inject; also facial swelling lt cheek; sl raised red area;									Y	10/25/1993	10/27/1993	2	NONE	OTH	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	VA93088	1						1	Face oedema; Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~3F41032~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0058007	12/06/1993	NY	53.0	53		M	11/15/1993	2 evenings p/flu shot pt exp severe abdo cramping, some diarrhea @ about 8PM on both 17OCT & 18OCT; also needle-like pains from waist to knees bilaterally;				Y					Y	10/15/1993	10/17/1993	2	NONE	PUB	OTH	Hydiodiuril	NONE	some BP elevations	NA~ ()~~~In patient		1						1	Abdominal pain; Diarrhoea; Pain	FLUX~PFIZER\WYETH~4938152~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058012	12/06/1993	CO				U		pt c/o chest tightness 10-15minsp/vax; BP 92/60, P80, R20;				Y					Y	11/03/1993	11/03/1993	0		PVT	PVT	NA	NONE	NONE	~ ()~~~In patient		1						1	Chest pain	FLUX~PFIZER\WYETH~4938180~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058013	12/06/1993	CA	42.0	42		F	11/26/1993	skin test & progressive challenge w/flu-devel generalized itching, urticaria, cough, wheezing;				Y					Y	11/26/1993	11/26/1993	0		MIL	MIL	Azmacort, Proventil	NONE	asthma, egg allergy as a child;	~ ()~~~In patient		1						1	Asthma; Cough; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~3J41148~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0058014	12/06/1993	SC	27.0	27		M	12/03/1993	inc temp, pneumonia, treated w/ATB x 10 days; sz day of vax w/in 24 hrs inc temp, refuse to eat, cough;				Y					Y	11/17/1993	11/17/1993	0	CXR, CBC;	OTH	OTH	Tegretol, Depakote, Diamox, Colace;		sz disorder, mental retardation;	~ ()~~~In patient		1						1	Anorexia; Condition aggravated; Convulsion; Cough; Pneumonia; Pyrexia	FLUX~PFIZER\WYETH~4938276~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058016	12/06/1993	TX	49.0	49		F	11/30/1993	onset @ 430PM of shaking chills, nausea, no vomiting; no sore throat, runny nose or cough; sore rt arm; t103.3; P80, R20, BP 98/60;				Y						11/30/1993	11/30/1993	0	NONE	PVT	PVT	Inderal, Xanas	NONE	some seasonal allergies;	~ ()~~~In patient		1						1	Chills; Hypotension; Myalgia; Nausea; Pyrexia; Tremor	FLUX~PFIZER\WYETH~3F41028~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058017	12/06/1993	ME	21.0	21		M	12/04/1993	pt exp pityriasis rosea 3 days p/vax;				Y					Y	10/05/1993	10/08/1993	3	GP visit; Dermatologist visit; no labs;	MIL	MIL	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~3J41019~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0058018	12/06/1993	MA	72.0	72		F	11/22/1993	pt recvd vax & got a rash starting on rt arm either lat 17NOV or 18NOV; rash was red, not raised, petechiae-like & there was little itching;									Y	11/16/1993	11/17/1993	1		PUB	PUB	Ativan;	NONE	NONE	NONE~ ()~~~In patient		1						1	Petechiae; Pruritus; Rash	FLUX~PFIZER\WYETH~4938083~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058019	12/06/1993	MA	44.0	44		F	11/18/1993	pt exp extreme tightness in chest, difficulty breathing, beginning the evening of shot & lasting approx 36 hrs; pt did not seek physician's care but treated self w/rest & nl meds;									Y	11/09/1993	11/09/1993	0		PUB	PUB	Theodur, Proventil;	no sx day of vax;	chronic asthma;	~ ()~~~In patient		1						1	Chest pain; Dyspnoea	FLUX~PFIZER\WYETH~4938083~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058025	12/07/1993	MI	52.0	52		F		cramping, sore calves x 2 wk; falls on steps, flat surfaces, dropping anything trying to carry; unable to get up when fall; affected even hair brushing, unable to open doors, dress self, fix meals; dx GBS-CIDP;					Y	13		Y		12/05/1991	01/05/1992	31	CBC, Thyroid, heavy metal poison; MRI-brain, EMG-neck;	UNK	UNK	THyroid, Premarin, Provera, Synthroid, multivitamins, MVI;		Menopause, hypothyroidism; all-PCN, Emycin, codiene;	~ ()~~~In patient		1						1	Asthenia; Coordination abnormal; Guillain-Barre syndrome; Hypertension; Muscle spasms; Myalgia; Neuropathy; Respiratory disorder	FLUX~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0058032	12/07/1993	AZ	78.0	78		F	11/30/1993	h/a, chills, weakness, nausea 3 hrs p/vax; was advised to take APAP every 4 hrs, fluid, rest; pt was better in 48 hrs;									Y	10/25/1993	10/25/1993	0	NONE	PVT	PVT	Calcium; Premarin, Elavil, Provera, Vitamins;	NONE	osteoarthritis, anxiety, hx of bleeding ulcers; hyperlipidemia systolic heart murmur;	~ ()~~~In patient		1						1	Asthenia; Chills; Headache; Nausea	FLU3~CONNAUGHT LABORATORIES~3F41141~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057886	12/08/1993	PA	51.0	51		F	11/14/1993	2 wks p/flu shot onset of progressive ascending motor weakness-GBS; resulting in quadreparesis;			Y		Y			Y		10/26/1993	11/09/1993	14	CSF prot 49;no cells; exam-flaccid quadraplegia; loss of reflexes;	UNK	UNK	Hypertension		Hypertension	~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome; Quadriplegia; Asthenia; CSF test abnormal; Dyspnoea; Guillain-Barre syndrome; Hyporeflexia; Myasthenic syndrome; Respiratory disorder	FLUX~UNKNOWN MANUFACTURER~4938084~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938084~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0058038	12/08/1993	NC	49.0	49		F	11/10/1993	pt recvd vax & began to feel dizzy, nauseated, weak, had chills x 1 1/2 hrs; also h/a, muscle aches; eventually went home but did not see MD;									Y	11/09/1993	11/09/1993	0		PUB	PVT				~ ()~~~In patient	NC9398	1						1	Asthenia; Chills; Dizziness; Headache; Myalgia; Nausea	FLU3~PARKE-DAVIS~01263P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0058042	12/08/1993	NY	68.0	68		M	11/12/1993	on adm 3NOV93 pt had petechial prupura lesions over legs, amrs & buccal mucos for 2 days; bleeding gums p/flossing pt also noticed petechial in mouth; recvd vax & ITP reoccurred 01NOV93;					Y					10/18/1993	11/01/1993	14	3NOV 10/13.7/42.6/4; 138/102/12/4.1/28/1; ppt 8; pt1; INK9;	UNK	UNK	Danazol;		BPH being followed by urology; hypercholestremic-controlled w/diet; splenectomyx2 in 1990; no allergies;	~ ()~~~In patient		1						1	Condition aggravated; Gingival bleeding; Petechiae; Purpura; Thrombocytopenic purpura	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0058043	12/08/1993	PA	84.0	84		M	11/17/1993	8OCT93 pt recvd flu vax on 20OCT93; pt was seen in MD office c/o rash & petechiae all over body; MD concluded p/reviewing labs pt had ITP, w/no other concurrent risk factors; thrombocytopenia x/receiving flu shot 2 wks prior;			Y		Y					10/08/1993	10/20/1993	12	platlet count-3000, CBC & diff, PTT-16.6 (11.7) 20OCT RBC-4.56;	UNK	UNK				~ ()~~~In patient		1						1	Laboratory test abnormal; Petechiae; Rash; Thrombocytopenia; Thrombocytopenic purpura; Epistaxis; Petechiae; Rash; Thrombocytopenia; Thrombocytopenic purpura	FLUX~PFIZER\WYETH~4938084~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938084~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation	Influenza
0058048	12/08/1993	CA	73.0	72		M	12/03/1993	nausea & emesis-chest pain;					Y	1			Y	10/13/1993	11/01/1993	19		PVT	PVT		NONE		~ ()~~~In patient		1						1	Chest pain; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~3F41124~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0058049	12/08/1993	CT				U		diarrhea x 2d-nausea emesis;									Y	10/04/1993	11/10/1993	37		PVT	PVT		NONE		~ ()~~~In patient		1						1	Diarrhoea; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~3F41124~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0058050	12/08/1993	CA	44.0	44		F	12/03/1993	chills;									Y	11/08/1993	11/10/1993	2		PVT	PVT		NONE		~ ()~~~In patient		1						1	Chills	FLU3~CONNAUGHT LABORATORIES~3F41124~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0058051	12/08/1993	CA	73.0	73		F	12/03/1993	nausea & emesis x 1 wk;									Y	10/13/1993	10/26/1993	13	NONE	PVT	PVT		NONE		~ ()~~~In patient		1						1	Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~3F41124~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0058052	12/08/1993	CA				M	12/03/1993	nausea diarrhea-body aches;									Y	11/03/1993	11/11/1993	8		PVT	PVT		NONE		~ ()~~~In patient		1						1	Diarrhoea; Myalgia; Nausea	FLU3~CONNAUGHT LABORATORIES~3F41124~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0057634	12/09/1993	CO	56.0	56		F	12/03/1993	15 mins p/vax pt devel clammy hands, neck pain, metallic taste in mouth, nausea; given DPH;				Y					Y	11/13/1993	11/13/1993	0	BP 162/94 (1030); 118/88 (1100);	PVT	PVT	Seldane, Tagamet	Asthma;		~ ()~~~In patient		1						2	Myalgia; Dysgeusia; Hyperhidrosis; Hypertension; Nausea; Neck pain	FLU3~CONNAUGHT LABORATORIES~3F41032~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~PFIZER\WYETH~361921~1~~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~2	USA	Emergency room visit	Influenza
0058053	12/09/1993	NC	71.0	71		M	11/18/1993	pt recvd vax 18OCT93 & approx 25OCT93 devel flu-like sx;  Approx 2NOV93 devel numbness & paralysis of the rt leg; next day was limping & losing control of hands; hospitalized to r/o a stroke; dx GBS;				Y	Y	32			N	10/18/1993	10/25/1993	7	Lumbar puncture: elevated protein, nerve conduction studies: nerve conduction slowed;	OTH	OTH	Vasotec 5 mg, Niacin 100mg; Zantac,	unk	hx of hypertriglyceridemia w/secondary development of pancreatitis, hypertenstion, type II diabetes mellitus; had a hx of a cold or flu-like illness in mid-OCT 1993; allergic to penicillin; GI intolerance of Lopid;	~ ()~~~In patient	893326001J	1						1	Asthenia; CSF test abnormal; Gait disturbance; Guillain-Barre syndrome; Influenza; Monoplegia; Neuropathy; Paraesthesia	FLUX~PFIZER\WYETH~4938181~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0058054	12/09/1993	PA	70.0	70		M	10/19/1993	18OCT93 numbness & tingling in rt had (3AM); numbness progressed to lips, face, head, arms & then to leg & entire rt side; numbness cont through 18OCt93; MD could not determine cause of sx GBS or cardiovascular incident;				Y					U	10/15/1993	10/16/1993	1	refused;	PUB	PUB	Potassium, Minipress, Ritalin, Children's ASA;	NONE	Hypertension, past hx of stroke in 1981	NONE~ ()~~~In patient	PA93157	1						1	Cardiovascular disorder; Cerebrovascular accident; Guillain-Barre syndrome; Paraesthesia	FLU3~PARKE-DAVIS~01173P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0058055	12/09/1993	IL	66.0	66		F	12/03/1993	heart pounding st segment irregularities, pain in upper back & shoulder & chest pain in pt who recvd flu vax; not feeling quite right; pt awoke again 6AM w/heart pounding & not feeling quite right; pt went to the ER & was treated;					Y	2			Y	10/13/1993	10/13/1993	0	18OCT93 EKG showed st irregularities; 19OCT93 pt passed thallium stress test;	PVT	OTH	NONE	NONE	NONE	NA~ ()~~~In patient	27830	1						1	Back pain; Chest pain; Electrocardiogram abnormal; Malaise; Pain; Palpitations	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0058060	12/09/1993	MD	31.0	31		F	11/01/1993	28OCT93 could not see things over rt side; bad h/a, sinus cold; dx optic neuritis; vision still blurry 8NOV93;				Y					N	10/20/1993	10/24/1993	4		PVT	PVT	Phenobarbitol for epilepsy;	NONE	epilepsy	NONE~ ()~~~In patient	MD93049	1						1	Amblyopia; Headache; Optic neuritis; Pharyngitis; Rhinitis; Sinusitis; Visual disturbance	FLUX~PFIZER\WYETH~4938182~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058061	12/09/1993	WV	68.0	68		M	11/16/1993	5 days p/vax appetite loss, feeling poorly; 10 days p/vax URI, cough & SOB; given amoxicillin; x-ray: LLL infiltrate; MD rx for poss pneumonia; SOB, hypoxic; arrested in hosp; revived but...; dilated cardiomyopathy; cardopulmonary arrest;	Y	11/08/1993			Y	16	Y		N	10/07/1993	10/12/1993	5	ejection fraction-227; echo dilated cardiomyopathy;	PVT	PVT	Feldene; Zyloprin; Normodyne; Calan SR;	NONE	No allergies noted Davocet allergy; old bilat cortial, infarcts, hypertension;	UNK~ ()~~~In patient	MD93052	1						1	Apnoea; Cardiac arrest; Cardiomyopathy; Dyspnoea; Hypotension; Hypoxia; Pneumonia; Renal failure acute	FLUX~PFIZER\WYETH~4938143~3~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0058062	12/09/1993	MD	80.0	80		M	11/02/1993	started cough approx 1 day p/receiving flu vax-treated by MD w/cough medicine; worsened; adm 28OCT93 in heart failure; had 6 beat run of v-tech;					Y	13	Y		Y	10/20/1993	10/21/1993	1	exction fraction 17%; echo showed dilated cardiomyopathy;	PVT	PVT	NONE t98.2;	NONE t98.2;	hx Ca colon; hx allergy to Demerol;	NONE~ ()~~~In patient	MD93053	1						1	Cardiac failure; Cardiomyopathy; Cough; Laboratory test abnormal; Ventricular tachycardia	FLUX~PFIZER\WYETH~4938262~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0058063	12/09/1993	MD	52.0	51		M	11/12/1993	adm to hosp 9NOV93-cardiogenic shock; severe idiopathic & cardiomyopathy currently w/acute resp failure, renal failure;					Y		Y		N	10/14/1993	11/09/1993	26	Echo-dilated cardiomyopathy;	PUB	PUB	NONE	NONE	allergic PCN	NONE~ ()~~~In patient	MD93054	1						1	Apnoea; Bundle branch block; Cardiomyopathy; Renal failure; Shock	FLUX~PFIZER\WYETH~4938143~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0058074	12/09/1993	PA	43.0	43		F	10/22/1993	fever, wheezing, joint pain; seen by MD;				Y					Y	10/14/1993	10/16/1993	2		PUB	PUB				~ ()~~~In patient	PA93153	1						1	Arthralgia; Asthma; Pyrexia	FLUX~PFIZER\WYETH~3F41024~4~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058079	12/09/1993	PA	67.0	67		M	11/03/1993	URI 20OCT93; dry cough; seen by MD;				Y					N	10/09/1993	10/20/1993	11		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	PA93159	1						1	Cough; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~3F41122~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0058083	12/09/1993	PA	81.0	81		M	10/25/1993	cough, runny eyes, dry throat; mucous in mouth; ache in diaphragm when coughing;									U	10/19/1993	10/22/1993	3		PUB	PUB	NONE	NONE	Hypertension	pt exp UR sxs @ 73 w/flu vax #2;~ ()~~~In patient	PA93163	1						1	Cough; Lacrimal disorder	FLU3~CONNAUGHT LABORATORIES~3F41027~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0058089	12/09/1993	PA	65.0	65		M	11/12/1993	pt exp cold like sx, had trouble swallowing; 7NOV devel stomach virus, explosive diarrhea; stomach rolled 8NOV; felt very tired, wanted to rest, lost of mucus; dx-MI, severe hardening of arteries, hypertension;	Y	11/08/1993							N	10/25/1993	11/06/1993	12	NONE	PUB	PUB	Vasotec;	NONE	vertigo-inner ear problem; bloodpressure rx;	~ ()~~~In patient	PA93171	1						1	Arteriosclerosis; Asthenia; Diarrhoea; Dysphagia; Infection; Myocardial infarction; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4938188~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0058094	12/09/1993	SC	48.0	48		M	11/18/1993	17NOV felt achy, tired, no energy, dec appetite indigestion about 1130PM, diarrhea w/cramping, nauseated; no vomiting; took immodium; 18NOV dizzy, feels bad; t101.2;									Y	11/15/1993	11/17/1993	2		PUB	PUB		NONE	NONE	~ ()~~~In patient	SC93142	1						1	Abdominal pain; Anorexia; Asthenia; Diarrhoea; Dizziness; Malaise; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41007~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0058095	12/09/1993	SC	79.0	79		F	11/24/1993	Pt recvd vax & felt badly; 8NOV felt worse; 9NOV seen by MD-CXR-clear; adm to hosp 15NOV93 died-dx strep pneumonia;	Y	11/15/1993							N	11/02/1993	11/03/1993	1	unk	PUB	PUB	UNK	NONE	unk	~ ()~~~In patient	SC93143	1						1	Infection; Malaise; Pneumonia	FLU3~CONNAUGHT LABORATORIES~3F41007~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0058099	12/09/1993	NY	68.0	68		M	11/15/1993	pt recvd flu vax 4NOV93 @ 3AM; 5NOV93 underside of lt arm inflammed; seen by MD;				Y					Y	11/04/1993	11/05/1993	1	NONE	PUB	PUB		NONE	NONE	~ ()~~~In patient		1						1	Injection site inflammation	FLUX~PFIZER\WYETH~4938182~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058104	12/09/1993	MI	55.0	55		F	12/03/1993	approx 10 hrs p/vax devel fever, malaise, myalgia & severe chills, treated self w/Advil, lot of blankets & early retirement for the noc;									Y	10/11/1993	10/11/1993	0		PVT	PVT	Premarin	NONE	NONE	~ ()~~~In patient		1						1	Chills; Malaise; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41142~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0058105	12/09/1993	MA	54.0	54		F	11/21/1993	violent h/a (11-3), runny nose (10-30), ache all over (10-30) sore arm, unable to function due to chest pains (5NOV to 17NOV), sore throat, blocked ears, loss of appetite, unable to go to work, weakness, coughing;									Y	10/29/1993	10/30/1993	1		PUB	OTH		NONE	hypertension-allergies	~ ()~~~In patient		1						1	Anorexia; Asthenia; Chest pain; Cough; Ear disorder; Headache; Myalgia; Pharyngitis	FLUX~PFIZER\WYETH~4938083~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058106	12/09/1993	MA	58.0	58		M	12/05/1993	h/a & sore throat; spitting up green/yellow flem, running nose, sore chest went on for @ least 10-14 days;									Y	11/08/1993	11/19/1993	11		PUB	OTH				~ ()~~~In patient		1						1	Chest pain; Headache; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4938083~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058119	12/10/1993	LA	63.0	63		F	10/12/1993	reports red rash covering trunk & extremities 2 dasy p/vax; seen by MD who dx pt react to flu shot;				Y					Y	10/04/1993	10/06/1993	2		PUB	PUB	Sectral, Seldene	sinus	hypertension	~ ()~~~In patient	LA931205	1						1	Rash	FLUX~PFIZER\WYETH~4938217~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058123	12/10/1993	MA	68.0	67		M	12/01/1993	sore throat-bad cough-4 wks; diarrhea x 3 days; fever x 5 days;				Y					Y	10/23/1993	11/08/1993	16		PUB	PUB		NONE		~ ()~~~In patient	MA9368	1						1	Cough; Diarrhoea; Pharyngitis; Pyrexia	FLUX~PFIZER\WYETH~4938083~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058124	12/10/1993	NH	22.0	21		F	12/06/1993	nasal congestion & vomiting 1 day p/flu shot;									Y	10/29/1993	10/30/1993	1	NA	PUB	PUB		NA	NA	NA~ ()~~~In patient	NH93030	1						1	Rhinitis; Vomiting	FLU3~CONNAUGHT LABORATORIES~3F41008~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0058126	12/10/1993	MA	72.0	72		M	12/05/1993	cold, cough, running nose, hoarseness, phlegm duration: 27OCT93-27NOV93;									Y	10/22/1993	10/27/1993	5		PUB	OTH		NONE		~ ()~~~In patient		1						1	Cough; Dysphonia; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058127	12/10/1993	MA	72.0	71		M	12/05/1993	26OCt93 hoarse, sneezing, coughing; 27OCT93 sore throat; glands felt swollen; felt so sick; cont wracking cough heavy phlegm for 2 wks; absolutly immobilized by illness;									Y	10/22/1993	10/26/1993	4		PUB	OTH		NONE		~ ()~~~In patient		1						1	Cough; Dysphonia; Lymphadenopathy; Malaise; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057012	12/13/1993	IL	80.0	79		M	12/07/1993	Acute memory loss w/inc temp; treated w/Acyclovir & 3rd generation cephalosporin;				Y	Y	4			U	10/18/1993	11/20/1993	33		PVT	PVT				~ ()~~~In patient	CO5175	1						2	Amnesia; Confusional state; Amnesia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~3F41010~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0058130	12/13/1993	GA				U	12/07/1993	Guillain Barre in a nurse; no other details;									U					UNK	UNK				~ ()~~~In patient	CO5165	1						1	Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058131	12/13/1993	MI				U	11/18/1993	Pt received vax; subsequently pt developed GBS;					Y				U					OTH	OTH	Unknown	Unknown	Unknown	~ ()~~~In patient	893333002J	1						1	Guillain-Barre syndrome	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0058132	12/13/1993	VA	73.0	73		M	11/16/1993	Dx in SEP93 w/large cell lymphoma of abdomen; recvd 3 courses of chemotherapy; 08OCT93 recvd vax; 28OCT93 exp weakness & skeletal pain; fell several times; admitted to hosp 29OCT93, dx of rule out GBS;	Y		Y		Y		Y		U	10/08/1993	10/28/1993	20	CSF protein 155;	OTH	OTH	VINCRISTINE, HYTRIN, HYDROCHLOROTHIAZIDE, PRILOSEC, MICRONASE, NORVASC, ISOSORBIDE DINITRATE, CYTOXAN, NOVANTRONE, NITROGLYCERIN OINTMENT;	Large cell lymphoma of abdomen;	Severe atherosclerotic cardiovascular disease, s/p coronary artery bypass graft, MIs, & large cell lymphoma of abdomen; non-insulin dependent diabetes mellitus;	~ ()~~~In patient	893321001J	1						1	Asthenia; CSF test abnormal; Dysarthria; Guillain-Barre syndrome; Hyporeflexia; Myasthenic syndrome; Myopathy; Neuropathy	FLUX~PFIZER\WYETH~4938167~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0058133	12/13/1993	CO	54.0	54		F	12/08/1993	Numbness of hands, legs, buttocks, mouth; hospitalized for 2 weeks; plasmapheresis administered (18 liters); released to rehab center; still unable to stand or walk after 3.5 weeks; numbness still present;				Y	Y		Y	Y	U	11/05/1993	11/15/1993	10	MRI, spinal tap, NIER, much lab;	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Asthenia; Back pain; Dysgeusia; Guillain-Barre syndrome; Hypokinesia; Paraesthesia; Paraesthesia oral; Asthenia; Back pain; CSF test abnormal; Gait disturbance; Guillain-Barre syndrome; Hypokinesia; Paraesthesia; Paraesthesia	FLUX~PFIZER\WYETH~4938262~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938262~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLUX~PFIZER\WYETH~49338262~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Hospitalisation,Disabling	Influenza
0058134	12/13/1993	VT	46.0	46		F	11/22/1993	2 wks p/vax pt devel numbness of legs below knees & numbness in fingers; admitted to hosp to rule out GBS;			Y		Y	7			U	10/18/1993	11/08/1993	21		PUB	OTH	Clinoril	UNKNOWN		~ ()~~~In patient	893333003J	1						1	CSF test abnormal; Guillain-Barre syndrome; Laboratory test abnormal; Paraesthesia	FLUX~PFIZER\WYETH~4938089~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0058135	12/13/1993	MA	73.0			M	12/07/1993	died; devel thrombocytopenia 2 wks p/vax; No autopsy performed;	Y	11/24/1993		Y	Y				N					PVT	PVT	Nitrodur patch 0.2 mg, tenormin 25 mg daily, aspirin 25 mg every other day;	None	MI & CVA 1991	~ ()~~~In patient	CO5163	1						1	Infection; Marrow hyperplasia; Pericardial effusion; Pneumonia; Pulmonary haemorrhage; Respiratory disorder; Thrombocytopenia; Thrombocytopenic purpura; Infection; Pericardial effusion; Petechiae; Pneumonia; Pulmonary haemorrhage; Respiratory disorder; Thrombocytopenia; Thrombocytopenic purpura	FLU3~PARKE-DAVIS~~4~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~CONNAUGHT LABORATORIES~~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0058135	12/13/1993	MA	73.0			M	12/07/1993	stroke p/developing thrombocytosis;	Y	11/24/1993			Y				N					PVT	PVT	Nitrodur patch, Tenormin, Enteric coated aspirin;	NONE	MI & CVA (1991); has moderate carotid artery stenosis;	~ ()~~~In patient	CO5164	1						2	Infection; Marrow hyperplasia; Pericardial effusion; Pneumonia; Pulmonary haemorrhage; Respiratory disorder; Thrombocytopenia; Thrombocytopenic purpura; Infection; Pericardial effusion; Petechiae; Pneumonia; Pulmonary haemorrhage; Respiratory disorder; Thrombocytopenia; Thrombocytopenic purpura	FLU3~PARKE-DAVIS~~4~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~CONNAUGHT LABORATORIES~~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0058137	12/13/1993	MD	46.0	46		M	12/07/1993	fever, confusion & agitation 2 days p/vax; picutre was consistent w/encephalitis by EEG & nl head CT/MRI;	Y				Y	18			N	10/12/1993	10/14/1993	2		MIL	MIL			HIV pos	~ ()~~~In patient	CO5166	1						1	Agitation; Anaemia; Asthenia; Confusional state; Encephalitis; Infection; Pyrexia; Stupor	FLU3~CONNAUGHT LABORATORIES~3J41026~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0058138	12/13/1993	PA	35.0	35		F	12/07/1993	Total blindness in rt eye; started w/intense pain behind rt eye, then blurred vision; dx as optic neuritis; treated w/meds for 3 days; 23NOV93 back @ work; vision is coming back, but still seeing shadows;				Y					N	10/22/1993	10/23/1993	1		OTH	OTH	NONE	29OCT93 2 week hx: h/a, blurred vision;	NONE	~ ()~~~In patient	CO5170	1						1	Amblyopia; Blindness; Eye pain; Optic neuritis; Visual disturbance; Amblyopia; Blindness; Optic neuritis	FLU3~CONNAUGHT LABORATORIES~3F41016~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~3F41016~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0058140	12/13/1993	CT	88.0	88		F	11/22/1993	pt recvd flu vax & 6 days later was noted to have a low white count & no neutrophils; meds were discontinued & pt was treated w/Neupogen; Bone marrow biopsy was performed, but results are unknown;			Y		Y	19			U	10/19/1993	10/29/1993	10		OTH	OTH	Lodine, Dyazide, Micronase 10 mg daily, sulfa drugs;	unk	pt has hypertension & diabetes mellitus & osteoarthritis;	~ ()~~~In patient	893333001J	1						1	Leukopenia	FLUX~PFIZER\WYETH~4938226~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0058142	12/13/1993	AK	50.0	50		F	10/12/1993	lt arm swollen, wheal-like red rash around inject site & upperarm, soreness & arthralgia; resolving by day 3;									Y	09/21/1993	09/22/1993	1		PUB	PUB		NONE	NONE	NA~ ()~~~In patient	AK93027	1						1	Arthralgia; Injection site hypersensitivity; Myalgia; Oedema peripheral	FLUX~PFIZER\WYETH~4938226~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~324954~1~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0058143	12/13/1993	AK	28.0	28		F	10/15/1993	1 hr p/vax c/o bodyaches & fever (did not take temp); next morning 6OCT93 c/o stiff nick on lt side by 1130AM was unable to move head stiffness extended down shoulder & lt arm; c/o muscle spasm; seen by MD;				Y					Y	10/06/1993			NONE	PUB	PUB	Inderal, Amitriptiline	NONE	prolapsed miltral valve	NONE~ ()~~~In patient	AK93028	1						1	Hypertonia; Hypokinesia; Myalgia; Nuchal rigidity; Pyrexia	FLUX~PFIZER\WYETH~4938226~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~324954~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0058144	12/13/1993	AK	47.0	47		M	10/15/1993	14OCT AM h/a, lethargy, muscle ache, chills, fever sx, arm warm, underneath armpit area, chest tightness;									Y	10/13/1993	10/14/1993	1	NONE	UNK	UNK	NONE	NONE	NONE-milk product intolerance		AK93029	1						1	Chest pain; Chills; Headache; Myalgia; Pyrexia; Somnolence; Vasodilatation	FLUX~PFIZER\WYETH~4938226~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~324954~1~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0058145	12/13/1993	AK	58.0	58		F	10/26/1993	25OCT93 TC from pt shot made sick, wanted to let know; approx 6 hrs p/inject c/o fever, chills, nausea then sl diarrhea; h/a									Y	10/19/1993	10/19/1993	0	NA	PUB	PUB		NONE		~ ()~~~In patient	AK93030	1						1	Chills; Diarrhoea; Headache; Malaise; Nausea; Pyrexia	FLUX~PFIZER\WYETH~4938226~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058146	12/13/1993	AK	48.0	48		F	11/01/1993	26OCT 245PM a/5PM c/o dull h/a & nausea; by 5PM exp diarrhea; c/o inc h/a & vomited all rest of 26OCT all of 27OCt; t101 x 2 days; slept most of 27OCT & 28OCT; felt better by 29OCT but still c/o h/a, queasy stomach & diarrhea;									Y	10/26/1993	10/26/1993	0	NA	OTH	PUB	NONE	sinus h/a	allergy to PCN	~ ()~~~In patient	AK93031	1						1	Diarrhoea; Headache; Nausea; Pyrexia; Somnolence; Vomiting	FLUX~PFIZER\WYETH~4938226~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058147	12/13/1993	AK	40.0	40		F	10/28/1993	315PM vax given; 317 urticaria @ inject site; 50mm area of red rashy area; tongue tingling throat scratchy; 415PM no further react; throat itchiness; 28OCT93 855AM pt report arm sore, difficult sleeping, rash, painful area;									Y	10/27/1993	10/27/1993	0	NA	PUB	PUB		sl flu	allergy to sulfa/PCN	NONE~ ()~~~In patient	AK93032	1						1	Injection site hypersensitivity; Insomnia; Myalgia; Pain; Paraesthesia oral; Pharyngitis; Rash	FLUX~PFIZER\WYETH~4938226~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~336944~2~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0058150	12/13/1993	CO	35.0	35		F	11/09/1993	pt recvd vax 1230PM; @2PM lips became swollen on the inside of the mough; lips were itchy & tingled lasted 24 hrs; lips cont to itch;									Y	11/04/1993	11/04/1993	0	NONE	PUB	PUB	Tri Levlen	had had diarrhea x 1wk;	NONE	NONE~ ()~~~In patient	CO93083	1						1	Face oedema; Paraesthesia oral; Pruritus	FLUX~PFIZER\WYETH~4938180~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058153	12/13/1993	CO	55.0	55		M	11/17/1993	1NOV93 pt recvd vax & 1 wk p/vax c/o sore throat, bronchial type cough & felt terrible all over;									Y	11/01/1993	11/17/1993	16	NONE	PUB	PUB	NONE	NONE	NONE	pt exp sore throat, bronchial type cough, felt terrible all over w/last flu shot~ ()~~~In patient	CO93086	1						1	Cough; Malaise; Pharyngitis	FLUX~PFIZER\WYETH~4938180~2~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058155	12/13/1993	CO	29.0	29		M	12/03/1993	petechiae 24x4cm area coverning brachial radialis from below elbow to back of hand on lt forearm; numbness of lt hand;				Y					N	12/03/1993	12/03/1993	0		PVT	PVT		NONE		~ ()~~~In patient	CO93088	1						1	Paraesthesia; Petechiae	FLU3~CONNAUGHT LABORATORIES~3F41032~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0058157	12/13/1993	IL	59.0	58		M	11/29/1993	death noticed in wkly newspaper-obituary had hx of hospitalization due to sz;	Y	10/23/1993							N	10/15/1993	10/23/1993	8	unk	PUB	PUB	unk	NONE	hypertension, sz disorder	UNK~ ()~~~In patient	IL93121	1						1	Apnoea; Cardiac arrest	FLUX~PFIZER\WYETH~4938086~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0058160	12/13/1993	IL	59.0	59		F	11/12/1993	40 minutes p/vax pt devel what appeared to be a nickel sized hive above rt eyebrow in midline of forehead; c/o itching, bump, redness; no other c/o;									Y	11/10/1993	11/10/1993	0		OTH	PVT		NONE	rheumatoid arthritis	~ ()~~~In patient	IL93124	1						1	Pruritus; Skin nodule; Urticaria; Vasodilatation	FLUX~PFIZER\WYETH~4938262~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058164	12/13/1993	MA	37.0	37		F	11/19/1993	1/2 hr to 1 hr later pt was tender @ joint then turned purple for 4 days-(whole finger); about 4-5 hrs later back (spineal column( & all around sides of back were extremely tender esp to touch;									Y	11/15/1993	11/15/1993	0		OTH	PUB		have had h/a for about 1mo	going to hosp h/a clinic (undiagnosed rt now);	~ ()~~~In patient	MA9370	1						1	Arthralgia; Back pain; Pain; Skin discolouration	FLUX~PFIZER\WYETH~4938083~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058173	12/13/1993	MO	73.0	73		F		got cold & then high fever;				Y	Y	5			Y	11/02/1993				PUB	PVT				~ ()~~~In patient		1						1	Chills; Pyrexia	FLUX~UNKNOWN MANUFACTURER~3F410003~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0058174	12/13/1993	NH	69.0	69		F	12/08/1993	28OCT recvd flu vax; 2NOV dizzy spells; 4NOV h/a; 5NOV seen by MD; 9NOV had pressure taken 160/180; 25NOV sick all day; 26NOV rapid heart beat & TIA:				Y	Y	4			Y	10/28/1993	11/26/1993	29	syncope-TIA;	PUB	OTH	Tenormine	NONE	Hypertension	NONE~ ()~~~In patient		1						1	Cerebral ischaemia; Condition aggravated; Dizziness; Headache; Malaise; Syncope; Tachycardia	FLUX~PFIZER\WYETH~4938083~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0058175	12/13/1993	CA	79.0	79		F		lt arm; muscle pain all the time; no redness; no swelling; arm is in constant pain from shoulder-elbow; can't move arm w/o severe pain;				Y						10/18/1993	10/19/1993	1		PUB	PUB	NONE	NONE	rag-weed; dust	NONE~ ()~~~In patient		1						1	Injection site pain	FLUX~PFIZER\WYETH~4938142~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058183	12/13/1993	ME	38.0	38		F	12/03/1993	1-2 hrs p/vax twitching in the arm where administered; 1 wk p/vax severe twitching & tingling in both arms & both legs, certain movements w/hand or fingers not smoothe, weakness in rt foot & leg;				Y					U	11/18/1993	11/18/1993	0		PVT	OTH	NONE	NONE	PCN allergy	~ ()~~~In patient		1						1	Muscle twitching; Myasthenic syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~3F41171~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0058189	12/13/1993	NH	53.0	53		M	12/07/1993	stomach discomfort 5NOV93; fever 6NOV-9NOV, stomach cramps/diarrhea (NOV-11NOV; treatment-bedrest & APAP;									Y	10/27/1993	11/05/1993	9		OTH	UNK	Lopressor			~ ()~~~In patient		1						1	Abdominal pain; Diarrhoea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058194	12/13/1993	CA	24.0	24		M	10/12/1993	pt c/o feeling lightheaded & weak 1050AM approx 30 mins p/vax;									Y	10/12/1993	10/12/1993	0	VS HR 60 @1030AM, HR 76, BP 120/80 @ 1055AM; HR84, BP 140/94 @ 1115AM;	OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Asthenia; Dizziness	FLUX~PFIZER\WYETH~4938158~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058195	12/13/1993	CA	59.0	59		F	12/08/1993	c/o fainting, warmth, nausea;									Y	10/21/1993	10/21/1993	0	unk'	OTH	PVT	unk	unk		unk~ ()~~~In patient		1						1	Nausea; Syncope; Vasodilatation	FLUX~PFIZER\WYETH~4938158~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058196	12/13/1993	CA	51.0	51		F	12/08/1993	noc sweats, coughing, chest discomfort, sneezing;									Y	10/08/1993	10/14/1993	6	NA	OTH	PVT	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Chest pain; Cough; Hyperhidrosis; Rhinitis	FLUX~PFIZER\WYETH~4938158~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058197	12/13/1993	CA	41.0	41		F	12/08/1993	pt stated is subject to anxiety attacks felt tingling in fingertips; pt took medication for anxiety attacks;									Y	10/18/1993	10/18/1993	0	NA	OTH	PVT	unk	unk	unk	unk~ ()~~~In patient		1						1	Paraesthesia	FLUX~PFIZER\WYETH~4938158~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058198	12/13/1993	CA	46.0			F	12/08/1993	diarrhea, vomiting, h/a, bodyaches;									Y				UNK	OTH	PVT	unk	unk	unk	unk~ ()~~~In patient		1						1	Diarrhoea; Headache; Myalgia; Vomiting; Diarrhoea; Headache; Nausea; Vomiting	FLUX~PFIZER\WYETH~4938158~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938158~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058198	12/13/1993	CA	46.0	46		F	10/15/1993	1130PM had diarrhea-nausea, vomiting, h/a lasted 1 hr;									Y	10/14/1993	10/15/1993	1	NA	OTH	PVT	Prinivil	NONE	NONE	NONE~ ()~~~In patient		1						2	Diarrhoea; Headache; Myalgia; Vomiting; Diarrhoea; Headache; Nausea; Vomiting	FLUX~PFIZER\WYETH~4938158~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938158~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058199	12/13/1993	CA				M	12/08/1993	c/o feeling tightness in head sent home-accompanied by relative;									Y	10/27/1993	10/27/1993	0	unk	OTH	PVT	unk	unk	unk	unk~ ()~~~In patient		1						1	Headache	FLUX~PFIZER\WYETH~4938158~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058200	12/13/1993	CA	27.0	27		M	12/08/1993	9NOV 12noon abdo cramping, h/a, bodyaches;									Y	11/06/1993	11/09/1993	3	unk/NA	OTH	PVT	UNK	unk	unk	unk~ ()~~~In patient		1						1	Abdominal pain; Headache; Myalgia	FLUX~PFIZER\WYETH~4938158~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058201	12/13/1993	CA	26.0	26		U		flu, coughing, flem, congestion;									Y	11/19/1993	11/22/1993	3	unk/NA	UNK	UNK	Insulin	unk	diabetes	unk~ ()~~~In patient		1						1	Cough; Influenza; Rhinitis	FLUX~PFIZER\WYETH~4938192~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058202	12/13/1993	CA	39.0	39		F	11/30/1993	c/o dizziness, feeling faint, hperventilating, anxious; hands were cool-skin warm/dry color pink;									Y	11/16/1993	11/16/1993	0	NA	OTH	PVT	Ativan, Retina A, Tetrcycline;	NA	NA	unk~ ()~~~In patient		1						1	Anxiety; Dizziness; Hyperventilation; Peripheral vascular disorder	FLUX~PFIZER\WYETH~4938158~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058203	12/13/1993	CA	50.0	49		F	10/14/1993	small sample given in lt arm to test poss allergic react devel 1 1/2 circumfrance-raised 1/4 in reddened-itches, sl temp, nausea;									Y	10/13/1993	10/13/1993	0	NA	OTH	PVT	Thyroid	NONE	allergy Gantrisan/sulfa	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Nausea; Pruritus; Pyrexia	FLUX~PFIZER\WYETH~4938158~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058204	12/13/1993	CA	33.0	32		M	10/05/1993	felt fever sl dizziness w/in 30 mins of inject lt arm stiffness & soreness 2 hrs p/inject; small bumps pin size in shape in various locations; sl reddness to bumps, itching;									Y	09/30/1993	09/30/1993	0		OTH	PVT	NA	NONE	NONE	NONE~ ()~~~In patient		1						1	Dizziness; Hypertonia; Myalgia; Pruritus; Pyrexia; Rash; Rash maculo-papular	FLUX~PFIZER\WYETH~4938158~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058205	12/13/1993	CA	61.0	61		M	11/17/1993	feet weak 2 days p/flu shot; also generalized weakness for 2 wks; sl numbness rt foot;									U	10/27/1993	10/29/1993	2	lab tests;	OTH	PVT	Mexitil; K-Dur; Vaseretic; Anaprox-on Procardia;	NONE	high blood pressure, tachycardia;	unk~ ()~~~In patient		1						1	Asthenia; Paraesthesia	FLUX~PFIZER\WYETH~4938192~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058206	12/13/1993	CA	32.0	32		M	11/18/1993	17DEC sick feeling-like had the flu, feels the same 2 days later; feel tired, chilly (cold);									Y	11/17/1993	11/17/1993	0	NA	OTH	PVT	UNK	NONE	unk	NONE~ ()~~~In patient		1						1	Asthenia; Chills; Influenza; Malaise	FLUX~PFIZER\WYETH~4938158~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058207	12/13/1993	CA	55.0	55		F	11/15/1993	sore throat 3NOV93; abdo cramps 4NVO93; SOB 5NOV93;									Y	11/03/1993	11/03/1993	0	Not known;	OTH	PVT	Not known	NONE	Not known	unk~ ()~~~In patient		1						1	Abdominal pain; Dyspnoea; Pharyngitis	FLUX~PFIZER\WYETH~4938158~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058208	12/13/1993	CA	57.0	57		F	11/18/1993	hot- hurt; by 7PM lt arm raised 3 diameter, swollen, 1/4 raised; 1 1/2 wk reddness still there-swelling; muscle in lt arm sore;									Y	11/04/1993	11/04/1993	0	unk	UNK	UNK	Premarin	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Myalgia; Pain; Vasodilatation	FLUX~PFIZER\WYETH~4938158~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058209	12/13/1993	CA	32.0	32		M	11/10/1993	hives-nothing x/hives; isolated to face & upper lt cheekbone-upper lt arm;									Y	11/09/1993	11/10/1993	1	NONE	OTH	OTH	Grisacitin	NONE	NONE	unk~ ()~~~In patient		1						1	Injection site hypersensitivity; Urticaria	FLUX~PFIZER\WYETH~4938158~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058210	12/13/1993	CA	27.0	27		M	11/19/1993	pt c/o swelling lt arm, pt stated tinkling of lt arm sl swelling noted on lt arm w/sl redness;									Y	11/16/1993	11/16/1993	0	NA	PVT	PVT	unk	unk	unk	unk~ ()~~~In patient		1						1	Oedema peripheral; Paraesthesia; Vasodilatation	FLUX~PFIZER\WYETH~4938158~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058211	12/13/1993	CA	33.0	33		M		became pale-light headed 10 mins p/shot;									Y	11/16/1993	11/16/1993	0	NA	OTH	PVT	unk	unk		unk~ ()~~~In patient		1						1	Dizziness; Pallor	FLUX~PFIZER\WYETH~4938192~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058212	12/13/1993	CA				U		became lighheaded;									Y	11/16/1993	11/16/1993	0	NA	OTH	PVT	unk	unk		unk~ ()~~~In patient		1						1	Dizziness	FLUX~PFIZER\WYETH~4938192~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058213	12/13/1993	CA	16.0	16		M	11/01/1993	began to pass out immediately upon receiving flu shot, out for only 5-10 seconds; VS BP 98/68; P68; resp reg skin w/d; woke up alert/oriented p/15 mins sitting down taking fruit juice, BP 90/64, P64; feeling much better p/30 mins sl h/a;									Y	10/29/1993	10/29/1993	0	NA	PUB	PVT	UNK	NONE	NONE	unk~ ()~~~In patient		1						1	Headache; Syncope	FLUX~PFIZER\WYETH~4938158~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058214	12/13/1993	CA	45.0	45		F	11/04/1993	c/o light headness c/o feeling warm lasted 15 mins;									Y	10/21/1993	10/21/1993	0		OTH	PVT	unk	unk	unk	~ ()~~~In patient		1						1	Dizziness; Pyrexia	FLUX~PFIZER\WYETH~4938158~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058215	12/13/1993	CA				F	10/26/1993	red spot @ inject site, soreness, flu-like sx, fever 102 degrees, blurred vision, dizzyness;									U	10/22/1993	10/23/1993	1		OTH	PVT		stevens-Johnson Synd		~ ()~~~In patient		1						1	Amblyopia; Dizziness; Influenza; Injection site hypersensitivity; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~4938158~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058216	12/13/1993	CA	56.0	56		F	10/26/1993	arm red & swollen shoulder to elbow;									Y	10/16/1993	10/16/1993	0		OTH	PVT	Not sure;			Not sure;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4938158~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058217	12/13/1993	CA	49.0	49		M	11/04/1993	c/o dizziness lasted 2-3 minutes;									Y	10/21/1993	10/21/1993	0	NA	UNK	PVT				~ ()~~~In patient		1						1	Dizziness	FLUX~PFIZER\WYETH~4938158~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058218	12/13/1993	CA	25.0	25		F	10/29/1993	began to get dizzy & sweaty, warm skin, immediately upon receiving vax; assisted to lie down VS BP 76/54, P100, T97.4; c/o mild h/a;									Y	10/29/1993	10/29/1993	0	NONE	PUB	PVT	NONE	NONE	NONE	Unk~ ()~~~In patient		1						1	Dizziness; Headache; Hyperhidrosis; Hypotension; Tachycardia; Vasodilatation	FLUX~PFIZER\WYETH~4938158~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058219	12/13/1993	CA				M	11/04/1993	26OCT hot & feverish skin wet & cold to touch, sl clammy; colon pab;									Y				NA	OTH	PVT	Not sure			~ ()~~~In patient		1						1	Hyperhidrosis; Pallor; Pyrexia	FLUX~PFIZER\WYETH~4938192~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058220	12/13/1993	LA	37.0	37		F	10/26/1993	heaviness in whole arm started in hand & up to arm;									Y	10/26/1993	10/26/1993	0	NA	OTH	UNK	NONE	NONE	allergic to PCN, sulfa, linocin, anesthetics, Chloroprocaine, Tetrocaine, Fucainylcholine, Procaine;	NONE~ ()~~~In patient		1						1	Asthenia	FLUX~PFIZER\WYETH~4938158~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058221	12/13/1993	CA	43.0	43		F	10/18/1993	soreness in arm-lethargic on Saturday 3-4 in raised 1/8 hand by Sunday;									Y	10/16/1993	10/16/1993	0	NA	UNK	UNK	Thyroid	NONE	NONE	NA~ ()~~~In patient		1						1	Myalgia; Skin nodule; Somnolence	FLUX~PFIZER\WYETH~4938158~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058222	12/13/1993	CA	40.0	40		F	10/25/1993	fever, slugglish, sore throat, started on Friday cont on Saturday; does feel a little better; sweating on Sunday does feel sl fever still;									Y	10/21/1993	10/22/1993	1	NA	OTH	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Hyperhidrosis; Pharyngitis; Pyrexia; Somnolence	FLUX~PFIZER\WYETH~4938158~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058224	12/13/1993	CA	53.0	53		F	10/08/1993	little bit of tightness in chest, upset stomach, nervous (anxiety attack);									Y	10/08/1993	10/08/1993	0	NA	OTH	PVT	vitamins	NONE	NONE	NONE~ ()~~~In patient		1						1	Anxiety; Chest pain; Dyspepsia; Nervousness	FLUX~PFIZER\WYETH~4938158~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058186	12/14/1993	MA	36.0	36		M	12/07/1993	begining w/lower nasal & back of throat irritation & mucus drainage; then lower throat very itchy, coughing up green-yellow mucus; fever & woke up @ noc, cold & soaking wet; sore throat; aching bones & mucles;									Y	10/28/1993	11/19/1993	22	NONE	UNK	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						1	Bone pain; Cough; Hyperhidrosis; Insomnia; Myalgia; Pharyngitis; Pruritus; Rhinitis	FLUX~PFIZER\WYETH~4938083~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058226	12/14/1993	NE	79.0	79		F	11/10/1993	pt recvd vax 27OCT93 following day felt achy & weak; 1NOV presented in ER w/fatigue, weakness, rapid pulse, dizziness & jaundice; hospitalized dx Coombs' negative hemolytic anemia (exact cause undetermined); still in hosp 9NOV93;					Y				N	10/27/1993	10/29/1993	2	HGB 8.3; HCT 20.4; MCV 76; Some nucleated RBC, Microcytosis & anisocytosis noted; basophilic stippling; sed rate >140; UA pos urobilinogen; bilirubin 4.3; direct 1.5: indirect 28; all elevated; direct antiglobulin test coombs neg;	PVT	PVT	Hydrochlorothiazide (dyazide);	HGB 14.7 on 11OCT93;	hypertension;	NA~ ()~~~In patient	930239201	1						1	Asthenia; Basophilia; Coombs negative haemolytic anaemia; Hyperbilirubinaemia; Jaundice; Reticuloendothelial system stimulated; Tachycardia; Urine analysis abnormal	FLU3~PFIZER\WYETH~359911~UNK~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation	Influenza
0058234	12/14/1993	HI	31.0	31		F	11/08/1993	24 hrs p/shot exp low grade temp w/fine rash to arms & legs only; took DPH for itching;									Y	11/03/1993	11/04/1993	1	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	HI9312	1						1	Pruritus; Pyrexia; Rash	FLU3~PFIZER\WYETH~3F41001~1~IM~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0058236	12/14/1993	MO	77.0	77		M	12/02/1993	20OCT93 onset head cold (dimetapp); 24OCT93 chest (lung) involvement; h/a, stiff neck, equilibrium disturbance 2-3 wks duration; bad cough & congestion w/above sx; generic ATB prescribed by MD;									Y	10/22/1993	10/24/1993	2	NONE	PUB	PUB	Chlorpamide (oral diabetes); Hytrin (prostate);	head cold 2 days-denied fever;	diabetes (mild) & prostate enlargement;	NONE~ ()~~~In patient	MO93121	1						1	Coordination abnormal; Cough; Headache; Nuchal rigidity; Rhinitis	FLU3~PFIZER\WYETH~3F41123~1~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0058237	12/14/1993	MO	58.0	57		F	12/06/1993	roar in ears for 3 days; very weak (speed up heartbeat & flutter); sharp pain in lower rt abod (required x-ray) took no high blood pressure med for 3 wks; cold sx-raw throat-chest congestion-cough;				Y					N	10/22/1993	10/22/1993	0	x-ray showed constipation; blood work okay;	PUB	PUB	Dyazide	NONE	PNC-sulfa-Keflex allergies); Blood pressure (but not real high);	~ ()~~~In patient	MO93122	1						1	Asthenia; Constipation; Lung disorder; Palpitations; Pharyngitis; Rhinitis; Tachycardia; Tinnitus	FLU3~CONNAUGHT LABORATORIES~3F41123~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0058238	12/14/1993	OH	32.0			F	12/03/1993	pt states felt fine p/vax until 12NOV93 sudden onset h/a, eyes hurt, couldn't move neck, on 13NOV93 went to hosp, adm; dx viral meningitis; discharged 23NOV93; not yet back to work by report 29NOV93;				Y	Y	10			Y	11/05/1993	11/12/1993	7	pt states lP done-viral meningitis;	PUB	PUB		NONE		~ ()~~~In patient	OH93095	1						1	Eye pain; Headache; Hypokinesia; Infection; Meningitis	FLU3~CONNAUGHT LABORATORIES~3F41142~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0058240	12/14/1993	SD	25.0	25		M	11/01/1993	Sat AM lump under lt arm (large marble size) gotten worse tender to touch-no redness, or warmth;										10/29/1993	10/30/1993	1		PUB	PUB		NONE	NONE	~ ()~~~In patient	SD93032	1						1	Pain; Skin nodule	FLUX~PFIZER\WYETH~4938180~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058247	12/14/1993	CA	22.0	22		M	11/22/1993	approx 15-20 mins p/shot c/o SOB, lungs clear, rash across chest shoulders & around shot site; pt came to acute care area of clinic; EPi & DPH given; Tachycardia & SOB & rash resolved p/tx;				Y					Y	11/22/1993	11/22/1993	0	NA	MIL	MIL	NONE	denies fever or s/s	chronic sinus congestion/? milk allergy;	NONE~ ()~~~In patient		1						1	Dyspnoea; Injection site hypersensitivity; Rash; Tachycardia	FLU3~CONNAUGHT LABORATORIES~3J41143~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0058254	12/15/1993	GA	26.0	26		M	11/20/1993	suffered about 1 1/2 hrs of chills, muscular convuls (moderate) in all limbs & torso (stomach area); this occurred @ 3AM the noc p/flu shot; no temperature taken; no recurring sx;									Y	10/27/1993	10/28/1993	1		PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Chills; Tremor	FLU3~CONNAUGHT LABORATORIES~~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0058267	12/16/1993	WV	67.0			M	10/08/1993	GBS after flu vax--hospitalized when diagnosis made 15NOV93;			Y		Y		Y		Y					PVT	PVT			Hypertension, ulcerative colitis; penicillin allergy;	~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLU3~PARKE-DAVIS~01293P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation	Influenza
0058268	12/16/1993	VA	66.0			M	12/12/1993	sore calves & thighs, some neck soreness, weakness of lips-unable to whistle;				Y					Y				LP nl 30NOV93;	UNK	UNK	Theo-dur	NONE	PCN	unk~ ()~~~In patient		1						1	Myalgia; Myasthenic syndrome; Neck pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058269	12/16/1993	MA	40.0	40		F	11/29/1993	approx 3-5 days p/inject devel severe joint & bone pain lasting approx 1 wk;									Y	10/15/1993	10/20/1993	5		PUB	PUB	NONE	NONE	Trees, grass, dust, mites, mold, mildew, cats, dogs;	~ ()~~~In patient		1						1	Arthralgia; Bone pain	FLUX~PFIZER\WYETH~4938083~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058270	12/16/1993	OR				F	12/02/1993	severe h/a, chills, lo grade fever-nausea-itching extremities; swelling-itching-burning lt deltoid lasted 1 1/2 days;									Y	11/29/1993	11/29/1993	0		PUB	PVT	Zoloft		allergic to chicken-fishes;	pt exp rxn 1963 @ 10 years old w/flu shot;~ ()~~~In patient		1						1	Chills; Headache; Injection site oedema; Injection site pain; Nausea; Pruritus; Pyrexia	FLUX~PFIZER\WYETH~4938280~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058271	12/16/1993	OR	57.0	57		F	11/24/1993	immediate tingling; redness progressing to vesicles in area of inject over 24-48 hrs; resolved w/in days;									Y	10/22/1993	10/22/1993	0	NONE-reported p/resolved;	OTH	PVT	vitamins/calcium	NONE	osteoporosis;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Paraesthesia; Hypokinesia; Myalgia; Myasthenic syndrome	FLUX~PFIZER\WYETH~4938145~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938145~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058272	12/16/1993	MA	66.0	66		M	12/10/1993	flu like sx 14 days p/vax; body aches & t101 lasting 3-4 days; mild bronchitis given ATB;									Y	10/25/1993	11/09/1993	15		OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Bronchitis; Influenza; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058280	12/17/1993	CA	45.0	45		F		A few hrs post inject noticed 2 marble sized lumps in rt arm; got up 15NOV, took shower & noticed red area, size of hand, sl raised warm to touch @ inject site;				Y						11/09/1993	11/15/1993	6	NONE	PUB	PUB	Tinoremin, Lopid, Estrase, Zantac	NONE	diabetic dx in 1992 controlled by diet;	NONE~ ()~~~In patient	CA93109	1						1	Cellulitis; Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~PFIZER\WYETH~359909~2~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|TD~LEDERLE LABORATORIES~356904~2~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058281	12/17/1993	CA	63.0	63		M	10/18/1993	rt arm very painful-shoulder to wrist; no swelling, no redness, no fever;										10/16/1993	10/16/1993	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	CA93110	1						1	Hypokinesia; Insomnia; Myalgia; Pain	FLUX~PFIZER\WYETH~4938146~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~330948~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0058282	12/17/1993	CA	45.0	45		F	10/27/1993	w/in approx 5 mins p/shots c/o dizziness & problems catching breath.  No apparent resp distress-R20; collapsed & became unconscious; VS remained WNL; 911 called; pt very unsteady on feet; anxiety react;				Y					Y	10/21/1993	10/27/1993	6		PUB	PUB	Psychotropic meds		hx anxiety reactions;	~ ()~~~In patient	CA93111	1						1	Anxiety; Dizziness; Dyspnoea; Syncope	FLUX~PFIZER\WYETH~4938148~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058283	12/17/1993	CA	51.0	51		F	10/13/1993	simple local deltoid react w/red, sl rasied 5cm x 5cm lesion; no other assoc sx's;									Y	10/11/1993	10/13/1993	2	NONE	PVT	PUB		NO acute illness;		~ ()~~~In patient	CA93112	1						1	Injection site hypersensitivity; Injection site mass	FLUX~PFIZER\WYETH~4938148~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058284	12/17/1993	CA	62.0	62		F	11/09/1993	15OCT93 late PM felt tired & weak; 18OCT had severe muscle & joint aches & stayed in bed; does not recall fever, chills, or feeling warm; did not take temp 19OCT had non productive cough; seen by MD 21OCT laryngitis; dx bronchitis;				Y					Y	10/12/1993	10/15/1993	3	NONE	UNK	PUB	NONE	NONE	NONE	~ ()~~~In patient	CA93113	1						1	Arthralgia; Asthenia; Bronchitis; Cough; Laryngitis; Myalgia	FLUX~PFIZER\WYETH~4938142~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058285	12/17/1993	MA	43.0	42		F	11/30/1993	red swollen lump @ site of inject x 4 days, arm pain, inc temp, fatigue-gen weakness/achiness; episode of syncope, chills/sweats;									Y	10/23/1993	10/23/1993	0		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MA9371	1						1	Asthenia; Hyperhidrosis; Injection site hypersensitivity; Injection site mass; Injection site oedema; Myalgia; Pyrexia; Syncope	FLUX~PFIZER\WYETH~4938083~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058286	12/17/1993	NC	59.0	59		F		pt reported swelling of face & ears;				Y					Y	11/12/1993	11/12/1993	0	NONE	PUB	PUB	denied	denied	allergy pain meds;	~ ()~~~In patient	NC93101	1						1	Face oedema	FLU3~PARKE-DAVIS~00763P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0058287	12/17/1993	NC	37.0	37		M	12/02/1993	Shaking, chills, dysesthesia, no fever X 8 weeks--still unresolved; labile HTN; absent deep tendon reflexes; possible modified GBS;				Y					N	10/07/1993	10/13/1993	6	Routine blood work, CXR, thyroid tests all nl;	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient	NC93102	1						1	Chills; Guillain-Barre syndrome; Hypertension; Hyporeflexia; Paraesthesia; Skin disorder; Tremor	FLU3~PARKE-DAVIS~01063P~1~SC A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0058288	12/17/1993	NJ	38.0	38		F	12/06/1993	Recvd call 02DEC93; c/o muscle & joint pain pins & needles in hands & toes; stated was in ER previous weekend; they advised being admitted for further testing; pt refused; 06DEC93 f/u call to home: pt was admitted to hosp 1AM today;					Y	5			U	11/15/1993	11/30/1993	15		PUB	PUB	Amoxicillin;			~ ()~~~In patient	NJ9328	1						1	Arthralgia; Myalgia; Paraesthesia	FLU3~PARKE-DAVIS~00873P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0058291	12/17/1993	SC	2.0	2	.1	F	12/10/1993	generalized edema & urticaria onset w/in 15 mins of vax; pt was teated in the ER & observed overnoc;				Y	Y	1			Y	12/10/1993	12/10/1993	0	NONE	PVT	PUB	Phenobarbital	NONE	cerebral palsy	~ ()~~~In patient		1						1	Generalised oedema; Urticaria	FLUX~PFIZER\WYETH~3F41007~UNK~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0058271	12/20/1993	OR	62.0	61		M		immediate soreness in muscle, persisting for month; feels has dec strength in arm & mobility limited;									Y	10/22/1993	10/22/1993	0		OTH	PVT		NONE	hx disruption of bicep '66;	~ ()~~~In patient		1						2	Injection site hypersensitivity; Paraesthesia; Hypokinesia; Myalgia; Myasthenic syndrome	FLUX~PFIZER\WYETH~4938145~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938145~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058298	12/20/1993	IN	73.0	73		M	12/13/1993	GBS; transferred to hosp; obtain details of hospitalization from hosp;			Y		Y				U	10/04/1993	10/16/1993	12		PVT	UNK	Coumadin, Lanoxin, Slo-bid, Isopten, Lasix, Propacef K-Lor;	NONE	Sulfa	~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLUX~PFIZER\WYETH~4938121~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~336944~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA	Life Threatening,Hospitalisation	Influenza
0058304	12/20/1993	IA	55.0	55		M	12/01/1993	12-days p/receiving flu c/o h/a, chills, achy joints, nausea, tiredness; 4NOV h/a excruciating, pain, stiffness lt side neck lasting & finally subsided 19NOV93; MD felt either viral meningitis or caused by flu shot;				Y					Y	10/20/1993	11/01/1993	12	WBC x 3, mono amylase, CAT Scan, chem profile;	PUB	PVT	NONE	getting over cold	denies	NONE~ ()~~~In patient	IA93034	1						1	Arthralgia; Asthenia; Chills; Headache; Infection; Meningitis; Nuchal rigidity; Pain	FLU3~CONNAUGHT LABORATORIES~3F41125~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~3D51079~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058312	12/20/1993	TX	55.0	55		F	10/05/1993	became feverish w/in a short time p/recvd inject; By Saturday rt arm was swollen & painful & had devel severe muscle achness;									Y	10/01/1993	10/01/1993	0	NONE	PUB	PUB		NONE	NONE	unk~ ()~~~In patient	TX93224	1						1	Myalgia; Oedema peripheral; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41009~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~336942~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0058319	12/20/1993	MO	80.0	80		F	12/11/1993	acute hepatocellular failure;	Y				Y				U	10/22/1993	11/26/1993	35		PVT	OTH	Capoten, HCTZ, K-tab, Quinine Sulfate;	hypertonia;	hypertension	~ ()~~~In patient		1						1	Hepatic failure	FLU3~PARKE-DAVIS~00863P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0058327	12/20/1993	MT	43.0	43		M	11/30/1993	2 days p/vax pt had chills, muscle aches, no fever, sl cough & malaise; sx lasted for 1 full day then pt started feeling better the next day;									Y	11/23/1993	11/25/1993	2	NONE	PVT	PVT	NONE	pt stated felt cold sx a/vax;	NONE	~ ()~~~In patient		1						1	Chills; Cough; Malaise; Myalgia	FLU3~CONNAUGHT LABORATORIES~3F41122~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0058336	12/20/1993	OR	72.0	72		M	11/15/1993	bodyaches & fever (unk); has red blister rash around waist of rt sides-burning pain-rash about 3 wks p/vax; did not go to PMD;  dx shingles caused by flu shot;				Y					Y	10/26/1993	11/09/1993	14		PUB	PVT		negative		pt exp rxn @ 69 w/flu vax #1;~ ()~~~In patient		1						1	Dermatitis bullous; Herpes zoster; Myalgia; Pain; Pyrexia	FLUX~PFIZER\WYETH~4938137~4~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057546	12/21/1993	ND	60.0	60		F	12/14/1993	2NOV93 dx as bursitis-sore shoulder, stiffness; 4NOV93 tingling sensation fingers, sore shoulder; 5NOV93 tingling & partial numbness; 6NOV93 paralyzed legs; GBS; 7NOV totally paralyzed; 8NOV ventillated; ICU-w wks;				Y	Y				N	10/21/1993	11/04/1993	14	spinal tap/protein level test (high);	PUB	PUB	NONE	NONE	NONE	pt exp myothrra w/flu vax #1;~ ()~~~In patient	ND93020	1						3	Bursitis; CSF test abnormal; Guillain-Barre syndrome; Pain; Paraesthesia; Paralysis; Respiratory disorder; Guillain-Barre syndrome; Neuropathy; Paralysis; Respiratory disorder; Bursitis; CSF test abnormal; Guillain-Barre syndrome; Hemiplegia; Pain; Paraesthesia; Paralysis; Respiratory disorder	FLUX~PFIZER\WYETH~4938140~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938140~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLUX~PFIZER\WYETH~4938140~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Hospitalisation	Influenza
0058346	12/21/1993	MI	52.0	52		F	12/13/1993	pt exp chills on evening of 26OCT93; next AM noted edema of axilla on arm used for inject along w/gradually inc vertigo & vomiting; seen by MD; had aching of entire body & was very tired, felt crummy x 2-3 wks;				Y					Y	10/26/1993	10/26/1993	0	MD checked throat & ears; no blood work was done;	OTH	PVT	Proventil tabs & inhaler; Theodur;	denies	asthma; allergic to animals, milk, dust & pollen (denies egg allergy);	NA~ ()~~~In patient		1						1	Asthenia; Chills; Malaise; Myalgia; Oedema; Vertigo; Vomiting	FLU3~CONNAUGHT LABORATORIES~3F41034~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0058348	12/21/1993	FL	59.0	59		F	11/18/1993	immed feeling tingling & stinging sensation in lt arm, later inc itching of nose, back of neck, scalp; pain in lt cheek bone radiating to ear-abated on Sat; Friday PM inc sensitivity to noise & arms still red & warm @ inject site;				Y					N	11/15/1993	11/15/1993	0		PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Ear pain; Injection site hypersensitivity; Injection site pain; Pain; Paraesthesia; Pruritus; Vasodilatation	FLU3~PARKE-DAVIS~00963P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0058349	12/21/1993	ME	58.0	57		F	12/10/1993	c/o red swollen, painful to touch lt arm; 36 hrs post vax c/o fever, chills, h/a, vertigo, nausea & diarrhea;									Y	12/08/1993	12/09/1993	1	None	PUB	PUB	Prozac, BP meds;	NONE	no known allergies, high blood pressure/medicated;	~ ()~~~In patient	ME93063	1						1	Chills; Diarrhoea; Headache; Oedema peripheral; Pain; Pyrexia; Vasodilatation; Vertigo	FLU3~PFIZER\WYETH~361921~UNK~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0058352	12/21/1993	MN	36.0	36		F	12/15/1993	devel nausea, vomiting w/in 24 hrs also had abd pain, has lost 12 lbs, unable to hold down food w/o meds; MD felt this is related to flu vax;									N	10/07/1993	10/08/1993	1	Endoscopy, colonoscopy, biopsy, UGI x-ray, flex, sigmoidoscopy; x-rays, O&P cultures & others;	PVT	PVT	Orudis	NONE	erythromycin, Tetracycline, Sulfa, Keflex, Vancomycin to Esthrin	NONE~ ()~~~In patient		1						1	Abdominal pain; Nausea; Vomiting; Weight decreased	FLUX~PFIZER\WYETH~4938141~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058354	12/21/1993	MI	59.0	59		F	12/13/1993	pt states that devel a h/a on the evening of vax & that it was constantly present x 21-23 days; It was not a migraine; there were no other sx & it did not prevent from working;									Y	10/22/1993	10/22/1993	0	NA	OTH	PVT	Vitamins	NA	NA	NA~ ()~~~In patient		1						1	Headache	FLU3~CONNAUGHT LABORATORIES~3F41034~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0058355	12/21/1993	TX	56.0	56		F	11/08/1993	erythematous, pruritic area 5x8 cm inject site, itching globally; no SOB; no fever;									Y	10/26/1993			NA	PVT	UNK		NONE		~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus	FLU3~PARKE-DAVIS~00763P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|OPV~PFIZER\WYETH~334956~1~IM~RA~POLIO VIRUS, ORAL (ORIMUNE)~1	USA		Influenza
0058133	12/22/1993	CO	54.0	54		F	12/01/1993	Pt recvd flu vax 5NOV93 & devel GBS; pt is currently being treated in a rehab institution; pt still can not walk or stand up;				Y	Y	12			N	11/05/1993	11/15/1993	10	LP-consistent w/GBS;	OTH	OTH	UNK	NONE		~ ()~~~In patient	893337001J	1						2	Asthenia; Back pain; Dysgeusia; Guillain-Barre syndrome; Hypokinesia; Paraesthesia; Paraesthesia oral; Asthenia; Back pain; CSF test abnormal; Gait disturbance; Guillain-Barre syndrome; Hypokinesia; Paraesthesia; Paraesthesia	FLUX~PFIZER\WYETH~4938262~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938262~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLUX~PFIZER\WYETH~49338262~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Hospitalisation	Influenza
0058359	12/22/1993	VA	42.0	42		M	11/24/1993	Pt recvd vax 4OCT93 & c/o numbness in feet; 29OCT93 had inc numbness & tingling in both feet, numbness was moving up both legs; dx polyneuropathy to r/o GBS;	Y			Y	Y				U	10/04/1993	10/15/1993	11		OTH	OTH	DTIC, Velban, Zofran, Decadron, Ativan, Adriamycin, Bleomycin;		Allergic to penicillin;	~ ()~~~In patient	893335001J	1						1	Myasthenic syndrome; Neoplasm malignant; Paraesthesia	FLUX~PFIZER\WYETH~4938167~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0058361	12/22/1993	PA	25.0			M	12/13/1993	rhabdomyalgia & myositis are reported in a pt NOV93 & approx 3 wks p/vax exp onset of myositis affecting muscles of arms, legs & back;  30NOV93 sed rate=100, CPK=14,000 & hematocrit=29; pt was hospitalized on 30NOV93					Y				Y	11/15/1993	11/30/1993	15	30NOV93 sed rate 100; CPk 14,000; Hematocrit 29;	MIL	OTH	NA	NS	NS	NS~ ()~~~In patient	27907	1						1	Anaemia; Blood creatine phosphokinase increased; Myalgia; Myositis; Pain; Red blood cell sedimentation rate increased	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0058362	12/22/1993	WV	76.0	76		M	11/24/1993	pt recvd vax 4OCT93 & was adm to the hosp 22OCT93 w/ascending polyneuropathy; pt conditon worsened following chemotherapy, & therefore was felt to be related to chemotherapy drugs;					Y				U	10/04/1993	11/22/1993	49		OTH	OTH	Mevacor, ASA, Cytoxan, Novantrone, Vincristine, Prednisone;	Lymphoma	Polyneuropathy	~ ()~~~In patient	893335002J	1						1	Antinuclear antibody; Neuropathy; Red blood cell sedimentation rate increased	FLUX~PFIZER\WYETH~4938167~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0058363	12/22/1993	OH	28.0			F	11/23/1993	pt recvd vax 6DEC91 & 18DEC91 devel hearing loss in lt ear; 27JAN93 dx w/profound sensorineural hearing loss of the lt ear; hearing loss cont to the date of this report;								Y	N	12/06/1991	12/18/1991	12		OTH	OTH	UNK	unk		~ ()~~~In patient	893336014J	1						1	Deafness	FLU3~PARKE-DAVIS~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Disabling	Influenza
0058367	12/22/1993	MA	65.0	65		F	12/12/1993	Pt recvd vax prior to 15NOV; 25NOV exp Proximal leg weakness L>R than weakness progressing by 28NOV could no longer walk; In past 2-3 days has had paresthesias fingers-thumbs; GBS;			Y		Y		Y			10/05/1993	11/25/1993	51	EMG	PUB	PUB		NONE	occ exertional angina/pyc procardia-NTBsl	~ ()~~~In patient	MA9373	1						1	Guillain-Barre syndrome; Hypokinesia; Myasthenic syndrome; Paraesthesia	FLUX~PFIZER\WYETH~4938083~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0058368	12/22/1993	MA	77.0	77		F	12/13/1993	pt recvd vax late October but may have had flu-like illness mid Nov; about 16NOV had leg aching but not weakness until several days later & soon thereabouts had paresthesia; paresthesia now in fingertips;			Y		Y	12	Y		N	10/28/1993	11/16/1993	19	EMG	PUB	PUB		NONE		~ ()~~~In patient	MA9374	1						1	Asthenia; Guillain-Barre syndrome; Influenza; Myalgia; Paraesthesia	FLUX~PFIZER\WYETH~4938119~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0058369	12/22/1993	OK	75.0	75		M	12/10/1993	devel high fever (?) went to hosp 18NOV93; had a stroke @ hosp on date of dismissal;					Y	21	Y		N	10/19/1993	11/18/1993	30		PUB	PUB	Cortisone; Thyroid	NONE	NONE	NONE~ ()~~~In patient	OK9358	1						1	Cerebrovascular accident; Pyrexia	FLUX~PFIZER\WYETH~4938153~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0058370	12/22/1993	VA				M	12/11/1993	pt devel neurologic myeline synd 4 days p/flu vax; unable to move upper & lower extremities; had bladder dysfunction & infiltration of cervical cord;					Y	720			N				CSF inc protein, inc WBC, MRI pahy myelits;	MIL	MIL	Valporic acid		history of encephalitis 1987;	~ ()~~~In patient		1						1	CSF test abnormal; Myelitis; Neuropathy; Quadriplegia; Urinary tract disorder	FLU3~CONNAUGHT LABORATORIES~3J41026~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0058371	12/22/1993	WI	61.0			F	12/15/1993	progressive bilateral visual loss 3-4 wks following vax; exam consistent w/bilateral anterior ischemic optic neuropathy;					Y			Y			11/04/1993		11NOV MRI brain & optic nerves neg; 2 LP; 12NOV bilateral temporal artery biopsy neg; ESR neg, ANA neg, anticardiolipils; leber's maker neg; lupus anticoagulent neg;	UNK	UNK			no allergies;	~ ()~~~In patient		1						1	Angiopathy; Blindness; Neuropathy; Amblyopia; Blindness; Neuropathy	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Hospitalisation,Disabling	Influenza
0058375	12/23/1993	NY	47.0	47		M	12/13/1993	brachial plexitis - approx 2 days following  injection, development of pain/numbness/tingling down arm to forearm, lt thumb tip numbness				Y					N	09/17/1993	09/19/1993	2		PVT	PVT	zestnil, ecotrin	none	s/p resection aortic aneurysm	~ ()~~~In patient		1						1	Hypoaesthesia; Neuritis; Pain; Paraesthesia	FLUX~PFIZER\WYETH~4938185~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0057886	12/27/1993	PA	51.0	51		F	11/22/1993	Pt recvd vax & on 9Nov93 exp ascending weakness of extremities, weakness progressed rapidly, unable to stand, had bulbar findings, dec reflexes, & develop resp distress, pt was intubated & admitted to hosp. Felt to have GBS. D/C on 7Dec93.			Y		Y	28		Y	N	10/19/1993	11/09/1993	21	bulbar findings, CT scan of head revealed no abnormalites, CSF protein-49, CSF cells -0	PUB	PUB	lisinopril, hydrochlorothaizide	unk	HTN, allgeric PCN	~ ()~~~In patient	893334002J	1						2	Asthenia; Guillain-Barre syndrome; Quadriplegia; Asthenia; CSF test abnormal; Dyspnoea; Guillain-Barre syndrome; Hyporeflexia; Myasthenic syndrome; Respiratory disorder	FLUX~UNKNOWN MANUFACTURER~4938084~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938084~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0058043	12/27/1993	PA	84.0	84		M	11/22/1993	pt recvd vax & on 10Oct93 presented to MD ofc w/ c/o of rash, petechiae & epistaxis, admitted to hosp w/ dx of idiopathic thrombocytopenic purpura. Underwent bone marrow biop was consistant w/ ITP. Platelet count improved.			Y	Y	Y	6			Y	10/08/1993	10/19/1993	11	platelet count 6,000/cumm, bone marrow biop consitent w/ ITP	PUB	PUB	coumadin, lasix	unk	coronary artery disease, CHF, post coronary artery bypass & aortic valve replacement '87	~ ()~~~In patient	893334001J	1						2	Laboratory test abnormal; Petechiae; Rash; Thrombocytopenia; Thrombocytopenic purpura; Epistaxis; Petechiae; Rash; Thrombocytopenia; Thrombocytopenic purpura	FLUX~PFIZER\WYETH~4938084~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938084~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation	Influenza
0058138	12/27/1993	PA				F	12/10/1993	pt reported to clinic on 2NOV93 possible side effect to flu vax; exp blurred vision on 23OCT93 w/total visual impairments on 27OCT93;				Y					U	10/22/1993	10/23/1993	1	treated by2 opthalmalogists who dx optic neuritis;	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						2	Amblyopia; Blindness; Eye pain; Optic neuritis; Visual disturbance; Amblyopia; Blindness; Optic neuritis	FLU3~CONNAUGHT LABORATORIES~3F41016~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~3F41016~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0058371	12/27/1993	WI	61.0	61		F	12/16/1993	bilat optic neuropathy & total vision loss, pt c/o of blurring vision, pt later developed bilat loss of vision, MD states pt's rt eye reactive to light & movement, lt eye reactive to light.Hosp 10Nov93,pt's vision returning to nl p/ surgery				Y	Y	3			Y	10/15/1993	11/07/1993	23	10Nov93 lumbar puncture=nl, MRI of brain & optic nerve=nl, sedimentation rate=nl, temporal artery biop=neg and rheumatological work-up=neg.	OTH	OTH			solu-medrol allergy	~ ()~~~In patient	28011	1						2	Angiopathy; Blindness; Neuropathy; Amblyopia; Blindness; Neuropathy	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Hospitalisation	Influenza
0058384	12/27/1993	ND	25.0	25		F		found dead in apartment, no suspicious circumstances. Autopsy results: lymphoma; no known cause of death.	Y	11/29/1993		Y					N	10/13/1993	11/29/1993	47	waiting on drug screen	MIL	MIL		none	none	~ ()~~~In patient	CO5196	1						1	Endocarditis; Haematemesis; Haemorrhage; Infection; Leukopenia; Lymphadenopathy; Necrosis; Pneumonia; Unevaluable event	FLU3~CONNAUGHT LABORATORIES~3J41148~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~3J41148~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0058385	12/27/1993	PA	44.0	44		F	12/21/1993	polyneuropathy w/ objective weakness lower extremities, onset approx 2 wks post vax.				Y					U	10/29/1993	11/12/1993	14		PVT	PVT				~ ()~~~In patient	CO5200	1						1	Myasthenic syndrome; Neuropathy	FLU3~CONNAUGHT LABORATORIES~3F41171~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0058387	12/27/1993	AR	39.0	38		F	11/12/1993	11NOV93 pt called to report diarrhea & vomiting & body aches starting @ 1PM p/vax; fever & red whelps on arms elbow to wrist, bumpy & sore; taken ASA referred to MD; to ER--spastic colon, having chills & hunger;				Y					Y	11/10/1993	11/10/1993	0	NONE	PUB	PUB	Voltarin, Premarin, Provachol; Anastag;	NONE	hi cholesterol & hypertension, spastic colon; allergy to mil product;	~ ()~~~In patient	AR9379	1						1	Chills; Condition aggravated; Diarrhoea; Increased appetite; Myalgia; Pyrexia; Urticaria; Vomiting	FLU3~CONNAUGHT LABORATORIES~3F41027~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0058392	12/27/1993	MA	53.0	53		F	12/13/1993	site tenderness lt deltoid, cervical neck pain;									Y	12/01/1993	12/08/1993	7	NONE	OTH	PVT	Monopril, Provera, Premarin;	NONE	high blood pressure;	NONE~ ()~~~In patient	MA9372	1						1	Injection site pain; Neck pain	FLUX~PFIZER\WYETH~4938183~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058393	12/27/1993	MA	79.0	79		F	12/13/1993	became ill w/inc congestion & h/a 1 wk p/inject ? related flu vax;				Y					Y	10/27/1993	11/03/1993	7		PUB	PUB	BP meds;	hx of inc BP	hx inc BP, bronchitis in past;	~ ()~~~In patient	MA9375	1						1	Headache; Rhinitis	FLU3~PARKE-DAVIS~00673P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0058405	12/27/1993	TN	54.0	54		M	12/16/1993	chills, fever, congestion, ache all over;										11/02/1993	11/20/1993	18		PUB	PUB				~ ()~~~In patient	TN93129	1						1	Chills; Myalgia; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~4938183~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058406	12/27/1993	TN	64.0	64		F	12/16/1993	23NOV sinus trouble, aching all over, sl fever, throat raw @ noc, flu like sx;				Y						11/11/1993	11/23/1993	12		PUB	PUB				~ ()~~~In patient	TN93130	1						1	Influenza; Myalgia; Pharyngitis; Pyrexia	FLUX~PFIZER\WYETH~4938183~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058408	12/27/1993	VA	58.0	58		F	12/14/1993	guillain barre syndrome documented					Y	15			U	11/09/1993	11/18/1993	9	nerve conduction; elevated CSF protein	PVT	PVT	lisiniopril, premarin, provera	none	HTN, osteoporosis	~ ()~~~In patient		1						1	CSF test abnormal; Guillain-Barre syndrome	FLU3~PARKE-DAVIS~010739~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0058409	12/27/1993	GA	60.0	60		M	12/21/1993	Pt admitted to hosp w\ generalized weakness, weak from waist down for last 2-3 days, no chills/pain/cough/fever, 21Nov93 low grade T, 22Nov93 progressive weakness upper body on ventilator,subclavin line for feeding & meds, bowel fxn probs			Y		Y		Y		U	11/01/1993	11/17/1993	16	17Nov93 WBC count 10.5, lymph low 18.9, grams 8.3, gra otto 79, sed rate sl high 33; 21Nov93 CSF-gram stain neg no WBC, RBC or yeast, Lab C reactive protein quality quantity pos titer 1-8, elevated epstein barr viral titer level, VCA titer1	PVT	PVT			nka	~ ()~~~In patient		1						1	Albuminuria; Atelectasis; Delirium; Gastrointestinal disorder; Guillain-Barre syndrome; Infection; Myasthenic syndrome; Respiratory disorder	FLUX~PFIZER\WYETH~4938149~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0058410	12/27/1993	NY	69.0	69		M	12/15/1993	pt coded @ home 4Dec93 (MI) in evening. Expired 14Dec93	Y	12/14/1993							N	12/14/1993	12/14/1993	0		PVT	OTH			hx of 4 recent MI's in past few yrs, obese 250 lbs, cardiac probs	~ ()~~~In patient		1						1	Chest pain; Influenza; Myocardial infarction; Stupor	FLU3~CONNAUGHT LABORATORIES~3F41123~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0058417	12/27/1993	ME	38.0	38		F	12/09/1993	IMD onset- h/a frontal severe diarrhea, muscle weakness, bed 3 days, lingered, better, then episodes. Head pain, neck pain. Finger, foot, tingling.				Y					N	10/01/1993	10/01/1993	0	CT scan 7Dec-neg	OTH	UNK	pain relievers, erythromycin	none	this summer traumatic birth, seasonal allergies	~ ()~~~In patient	ME93060	1						1	Diarrhoea; Headache; Myasthenic syndrome; Neck pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0058384	12/28/1993	ND	25.0	25		F	12/27/1993	pt found expired in apartment 29NOV93. Time of death early 27Nov93	Y	11/27/1993							N	10/13/1993	11/27/1993	45	autopsy report revealed no organic cause of death	MIL	MIL	none	none	none	~ ()~~~In patient	ND93025	1						2	Endocarditis; Haematemesis; Haemorrhage; Infection; Leukopenia; Lymphadenopathy; Necrosis; Pneumonia; Unevaluable event	FLU3~CONNAUGHT LABORATORIES~3J41148~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~3J41148~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0058541	12/28/1993	WI	64.0	64		F	11/08/1993	rt arm pain-unable to lift above shoulder off from work for 3 days; contact w/MD; ice gave no relief-flu shot in rt arm;				Y					Y	10/25/1993	10/25/1993	0	NA	OTH	PUB	Vastec	NONE	inc BP;	~ ()~~~In patient	WI93090	1						1	Hypokinesia; Pain	FLUX~PFIZER\WYETH~4938147~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~324907~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0058542	12/28/1993	WI	47.0	47		M	11/04/1993	pt recvd vax 28OCT93; began exp hives 2NOV93; seen by nurse then MD; allergist had pt take DPH;									U	10/28/1993	11/02/1993	5		PUB	PUB	Glucatrol	NONE	environmental-takes allergy shots; had diabetes;	~ ()~~~In patient	WI93091	1						1	Urticaria	FLU3~PFIZER\WYETH~324907~2~~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|PPV~UNKNOWN MANUFACTURER~00573P~1~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0058543	12/28/1993	WI	27.0	27		M	11/12/1993	10 mins p/vax pt exp weakness, dizziness, sl-mod dyspnea & throat tightness & VS were low & weak; BP 112/50, 16, 52; also pale w/circumoral pallor & cold; some irregular pulse occurred; shivering;  slept 12 hrs;				Y					Y	11/12/1993	11/12/1993	0	NONE	OTH	PUB	NONE	recently over a cold;	as a toddler had allergic rxn to polycillan	NONE~ ()~~~In patient	WI93092	1						1	Arrhythmia; Asthenia; Chills; Dyspnoea; Hypotension; Laryngospasm; Pallor; Somnolence	FLU3~PARKE-DAVIS~00583P~1~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0058545	12/28/1993	WI	69.0	69		F	11/05/1993	27OCT93 chills, fever (had cold 3 wks, earlier, sl cough); 1NOV93 walking pneumonia-rx Cipro-seen by MD;				Y						10/25/1993	10/27/1993	2		PUB	PUB		sl cough-no temp	NONE	~ ()~~~In patient	WI93094	1						1	Chills; Pneumonia; Pyrexia	FLUX~PFIZER\WYETH~0948149~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058548	12/28/1993	WI	47.0	47		F	11/23/1993	1 hr sore, hardened, red, started draining, green, yellow drainage; rx w/Vantilin;				Y					Y	11/06/1993	11/06/1993	0	urine & blood test nl;	PUB	PVT	NONE	NONE	PCN, sulfa, Ibuprofin, Hypertension, THyroidism;	~ ()~~~In patient	WI93097	1						1	Infection; Myalgia; Skin nodule; Vasodilatation	FLUX~PFIZER\WYETH~4938147~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058133	12/29/1993	CO	54.0	54		F	12/14/1993	called on 16NOV to report numbness in hands & feet beginning day a/; referred to pvt MD: hospitalized;					Y				N	11/05/1993	11/16/1993	11	NA	OTH	PVT	unk	unk	unk	~ ()~~~In patient	CO93089	1						3	Asthenia; Back pain; Dysgeusia; Guillain-Barre syndrome; Hypokinesia; Paraesthesia; Paraesthesia oral; Asthenia; Back pain; CSF test abnormal; Gait disturbance; Guillain-Barre syndrome; Hypokinesia; Paraesthesia; Paraesthesia	FLUX~PFIZER\WYETH~4938262~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938262~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLUX~PFIZER\WYETH~49338262~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Hospitalisation	Influenza
0058549	12/29/1993	DC	61.0	61		F	11/29/1993	pt recvd vax 16SEP93 & on 23SEP sl swelling of thighs & feeling of skin tightness; 27SEp limping secondary to rt knee swelling; 30SEP rt lower extremity weakness requiring cane, then crutches to walk; 5OCT hospitalized; MRI; dx trans myelit					Y	4			Y	09/16/1993	09/23/1993	7	MRI of cervical & Lumbar spine w & w/o Gadolinium 6OCT93 showed spinal cord swelling @ the level of T3 to T4; Brain MRI 6OCT WNL: CBC, PT, PTT< CHEm 6, Urinalysis all WNL; hosp summary & radiology reports available;	PVT	OTH	NA		hx of hypertension, Lumbar radiculopathy, hypercholesterolemia; MAY92 had low back pain, lt leg weakness (EMG showed denervation of lt lower extremity muscles consistent w/L5 radiculopathy);	NA~ ()~~~In patient	930249301	1						1	Gait disturbance; Laboratory test abnormal; Myasthenic syndrome; Myelitis; Oedema peripheral; Osteoarthritis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation	Influenza
0058557	12/29/1993	CO	26.0	25		F	12/02/1993	pt recvd vax 28OCT93 & 31OCT93 devel fever, diarrhea; seen by MD 5NOV93; poss viral illness; 6NOV93 devel rash over entire body which lasted 1 wk w/itching;				Y						10/28/1993	10/31/1993	3	CBC- dec WBC; mono test neg;	OTH	PVT	NONE	NONE	NONE	NA~ ()~~~In patient	CO93091	1						1	Diarrhoea; Infection; Leukopenia; Pruritus; Pyrexia; Rash	FLUX~PFIZER\WYETH~4938217~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058558	12/29/1993	CO	58.0	58		F	12/13/1993	had flu vax 10DEC93; 11DEC93 had nausea, vomiting & severe h/a for 2 days; 13DEC93 sx were gone;									Y	12/10/1993	12/11/1993	1	NA	PUB	PUB	AMoxicillin, Atavan, PRemarin, Nortiptyline, Altace;	c/o sinus infecting;		NA~ ()~~~In patient	CO93092	1						1	Headache; Nausea; Vomiting	FLUX~PFIZER\WYETH~4938145~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058562	12/29/1993	PA	45.0	45		F	12/03/1993	pt recvd shot 26OCT93 1 wk later came down flu; fever 101.7, chills, ache;				Y					Y	10/26/1993	11/01/1993	6	NONE	PUB	UNK	Norvasc, PRemarin;	NONE	hypertension & kidney stones (sponge kidney);	NONE~ ()~~~In patient	PA93176	1						1	Chills; Influenza; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41032~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0058572	12/29/1993	PA	43.0	42		M	12/03/1993	23OCT severe h/a, migraine-like x 1 day; hematoma @ site of inject; pt has taken flu shot previously; soreness @ site, sore to touch;									N	10/20/1993	10/22/1993	2	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	PA93186	1						1	Headache; Injection site haemorrhage; Injection site pain; Migraine	FLU3~CONNAUGHT LABORATORIES~3F41032~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0058574	12/29/1993	NJ	69.0	69		F	12/22/1993	arthralgias progressive over 2 wks; dec voltage on ECG; echocardiogram pricardial effusion; tx w/Pred;					Y	5			Y	10/01/1993	10/27/1993	26	definitively pos ANA, inc ESR-responsing to steroid;	PUB	UNK				~ ()~~~In patient		1						1	Antinuclear antibody; Arthralgia; Electrocardiogram abnormal; Pericardial effusion; Pericarditis; Red blood cell sedimentation rate increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0058576	12/29/1993	MO	60.0	60		M	12/16/1993	2 wks p/flu shot, pt developed GBS; in a 46 day hospitalization, the pt required mechanical ventilation, plasmapheresis, 2 endotracheal tubes, 2 vascular catheters, PEG & dobhoff tube;			Y		Y	46				10/07/1993	10/22/1993	15	22OCT CSF: RBC 2, glucose 75, protein 85; urine arsenic, lead, mercury & prophyrins negative; VDRL neg; Crypto neg; CSF fluid for bacteria, fungus, yeast neg;	UNK	UNK			borderline HTN (untreated); perhaps had Rocky Mountain spotted fever in 1947, no sequelae; NKA;	~ ()~~~In patient		1						1	CSF test abnormal; Guillain-Barre syndrome; Respiratory disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0058585	12/29/1993	NY	61.0			M	12/22/1993	malaise, muscel aches, chest pain;									Y	10/28/1993	10/29/1993	1	EKG done;	PVT	OTH		NONE	NA	NA~ ()~~~In patient		1						1	Chest pain; Malaise; Myalgia	FLU3~PARKE-DAVIS~00963P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0058586	12/29/1993	NY	46.0	46		F	12/22/1993	fever 103, rash diarrhea, weakness, chills, malaise, hives, h/a, muscle aches;									Y	10/29/1993	10/30/1993	1	NA	PVT	OTH	NA	NONE	NA	NA~ ()~~~In patient		1						1	Asthenia; Chills; Diarrhoea; Headache; Myalgia; Pyrexia; Rash; Urticaria	FLU3~PARKE-DAVIS~00963P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0058588	12/29/1993	AK	46.0	46		F	11/05/1993	pruritus over face approx 90 minutes p/vax; gradually subsided over next 30 mins w/o;									Y	10/28/1993	10/28/1993	0		OTH	PUB		NONE	NA	NA~ ()~~~In patient		1						1	Pruritus	FLUX~PFIZER\WYETH~4938226~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~MERCK & CO. INC.~1014V~2~IM~~HEP B (RECOMBIVAX HB)~1	USA		Influenza
0058589	12/29/1993	AK	56.0	56		F	11/05/1993	onset of sx 5 days post vax; h/a, overall myalgia, lethargic, stomachache & diarrhea;									Y	10/26/1993	10/31/1993	5	NA	OTH	UNK		None	CHD, hypertension	NA~ ()~~~In patient		1						1	Abdominal pain; Diarrhoea; Headache; Myalgia; Somnolence	FLUX~PFIZER\WYETH~4938226~3~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~324954~1~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0058594	12/30/1993	IL	14.0	14		F	12/27/1993	pt began influenza type sx: h/a, cough, sore throat, low grade temp, fatigue, inability to eat on 25OCT; 4NOV had lost approx 15 lbs-h/a (sever), muscle aches, weakness; trouble keeping eyes open;					Y		Y		U	10/05/1993	10/25/1993	20	dx viral syndrome; CBC-chem 20 monospot; spinal tap; CAT Scan  of head all normal;	PVT	OTH		NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome; Headache; Influenza; Myalgia; Pharyngitis; Pyrexia; Weight decreased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0058773	01/03/1994	ME	39.0	39		F	12/29/1993	about 1 wk p/vax pt has pain @ the top of rt femur when walks; does not have pain when not walking;									N	12/15/1993	12/27/1993	12	NONE	PUB	PUB	NONE	NONE	allergic to PCN	~ ()~~~In patient	ME93064	1						1	Bone pain	FLU3~PFIZER\WYETH~361921~1~IM~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0058774	01/03/1994	ME	10.0	10		M	12/29/1993	about 1 wk p/vax pt exp vomiting low grade fever 100, pain in the hips & back; stayed in bed & was better in 2 days;									Y	12/15/1993	12/23/1993	8	NONE	PUB	PUB	Intol	NONE	asthma	~ ()~~~In patient	ME93065	1						1	Arthralgia; Back pain; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~361921~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0058780	01/03/1994	NJ	58.0	57		F	12/23/1993	rash over entire body, itching & burning sensation; t101, difficulty breathing, closed throat; oral cortizone given 1st day of sx; injected cortizone given 4th day of sx; lasted 10 days;			Y	Y					Y	10/18/1993	10/18/1993	0	NONE	PUB	PUB			allergies: plants & many vegetables;	~ ()~~~In patient		1						1	Dyspnoea; Laryngospasm; Pain; Pruritus; Pyrexia; Rash	FLU3~PARKE-DAVIS~~1~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~357943~1~A~~PNEUMO (PNU-IMUNE)~1	USA	Life Threatening	Influenza
0058782	01/03/1994	CA	33.0	33		M	12/28/1993	fever, sz, coma; not believed to be vax related;			Y		Y	14			Y	11/11/1993	11/11/1993	0	had pneumococcal meningitis; pos blood cultures for pneumococcal-w/bacteremia; neg CSF; 15000 cell in CSF;	OTH	PUB		pneumonia 1 month previously	s/p pituitary surgery 1989, growth treated;	NONE~ ()~~~In patient		1						1	CSF test abnormal; Coma; Convulsion; Infection; Meningitis; Pyrexia; Sepsis	FLU3~CONNAUGHT LABORATORIES~3F41172~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0058787	01/03/1994	NC	26.0	25		F	11/11/1993	pt recvd vax on 28OCT93 & started breaking out in a rash on the following Sunday; rash became worse; broke out in hives on 1NOV93; went to ER;				Y					Y	10/28/1993	11/01/1993	4		PUB	PVT		NONE	NONE	~ ()~~~In patient		1						1	Rash; Urticaria	FLUX~PFIZER\WYETH~4938122~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058796	01/03/1994	OH	33.0	33		F	11/24/1993	pt recvd vax 19NOV93 @ 1530; 22NOV t99.6, h/a, sore throat, achy joints, congestion & chest, throat, tired;									U	11/19/1993	11/22/1993	3	NONE	PUB	PUB	Synthroid, Prenatal vit	NONE	NONE	~ ()~~~In patient		1						1	Arthralgia; Asthenia; Headache; Lung disorder; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41009~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0058806	01/04/1994	MA	56.0	56		M	12/21/1993	14DEC92 pt called c/o lt foot bloating & swelling 1 wk p/flu shot; lt foot to mid calf nubness, lt hand squeezing & burning, spastic pain; seen by MD but did not indicated that thought was from flu vax;									U	10/21/1993	10/23/1993	2	unk	PUB	PUB	unk		hx of mild acute bronchitis, cervical spondylosis w/riducolopathy of the lt hands & sacroilliac problems;	~ ()~~~In patient	MA9377	1						1	Condition aggravated; Oedema peripheral; Pain; Paraesthesia	FLUX~PFIZER\WYETH~4938083~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058809	01/04/1994	MN	41.0	40		F		aching pain in lt arm, lt shoulder & lt jaw following shot; pain got worse @ noc & p/1 month has gotten better but not gone & lt shoulder ROM limited due to pain;				Y					N	10/15/1993	10/15/1993	0	x-ray; ultrasound;	PUB	PVT		NONE	NONE	~ ()~~~In patient	MN93067	1						1	Hypokinesia; Myalgia; Pain	FLUX~PFIZER\WYETH~4938121~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058813	01/04/1994	NC	50.0	49		F	12/09/1993	2DEC started w/itching & rash bilateral hands & arms; hives spread all over body; took DPH; 3DEC hives worse & throat felt like closing; taken to ER & given DPH; 6DEC ER again w/tachycardia & SOB & anxiety;				Y					Y	12/01/1993	12/02/1993	1	NONE	PUB	PUB	NONE	NONE	NKA; no medical problems;	NONE~ ()~~~In patient	NC93105	1						1	Anxiety; Dyspnoea; Laryngospasm; Pruritus; Rash; Tachycardia; Urticaria	FLUX~PFIZER\WYETH~4938280~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058814	01/04/1994	NC	57.0	57		F		25OCT93 numbness @ waist around 1/2 of body; 9NOV93 numbness of lt leg seen by MD; 11NOV92 couldn't urinate 1035PM; adm to hosp;					Y	4			N	10/21/1993	10/25/1993	4		PUB	PUB	multivitamin; Estrogen replacement therapy	NONE	allergic to PCN	NONE~ ()~~~In patient	NC93106	1						1	Dysuria; Paraesthesia	FLU3~PARKE-DAVIS~00873P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0058818	01/04/1994	ND	86.0			M	10/01/1993	acute mental status change; orientated to self, but not place/time; found wondering in yard looking for wife, who died 3 months ago;					Y					09/30/1993	10/01/1993	1		UNK	UNK				~ ()~~~In patient		1						1	Confusional state	FLUX~PFIZER\WYETH~4938145~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0058819	01/04/1994	WA	2.0	2	.9	F	11/19/1993	pain, dec ambulation rt hip; no temp; mild URI x 3d; onset 11NOV; recvd vax 10NOV;				Y					Y	11/10/1993	11/11/1993	1	Ortho consult; WBC 12.5-53P; ESR 13; CRP<0.8; Blood cult neg;	PVT	PVT	NA		NONE	NONE~ ()~~~In patient		1						1	Hypokinesia; Leukocytosis; Pain; Pharyngitis	FLUX~PFIZER\WYETH~4938145~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058834	01/06/1994	IN	82.0	82		M	11/16/1993	pt recvd vax 11NOV93 & 13NOV93 devel swelling of the lips & face, raised, non pruritic rash, nausea, abdo pain, & severe h/a; seen in ER treated w/Toradol & Solu-Medrol; 16NOV92 devel swelling of the throat & tongue; dx of vasculitis;				Y	Y	4			U	11/11/1993	11/13/1993	2	16NOV93 WBC 14,900; 19NOV93 Manual differential-Plasmacytoid & atypical lymphs present;	OTH	OTH	unk	unk	unk	~ ()~~~In patient	893323001J	1						1	Abdominal pain; Face oedema; Laryngospasm; Leukocytosis; Rash maculo-papular; Tongue oedema; Vasculitis; White blood cell disorder	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0058835	01/06/1994	CA	87.0	87		F	12/08/1993	Time of vax 7OCT93 & 1 wk later c/o severe weakness in both legs for 1 wk duration;  2 wks later pt had severe pain in the lt leg, bilateral lower extremity weakness; adm to hosp 18NOV93 w/hypertension, r/o cerebrovascular accident;				Y	Y	2			N	10/07/1993	10/14/1993	7		PUB	OTH	Dyazide, Levothyroxin	unk	Hypertension & obstructive airway disease;	~ ()~~~In patient	893347001J	1						1	Cerebrovascular accident; Dizziness; Gait disturbance; Myasthenic syndrome; Pain	FLUX~PFIZER\WYETH~4938184~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0058839	01/06/1994	WA	58.0	58		F	11/09/1993	hematoma following flu shot cellulitis following that;									Y	11/03/1993	11/04/1993	1	NA	PVT	PUB	NONE	NONE	NONE	NA~ ()~~~In patient	WA93977	1						1	Cellulitis; Haemorrhage	FLU3~PARKE-DAVIS~00763P~3~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0058840	01/06/1994	WA	42.0	42		F	11/23/1993	pains in arm began 4 days p/flu shot; pain went down arm & lasted 1 wk; no joint pain when asked; resolved;									Y	11/02/1993	11/06/1993	4	NA	PUB	PUB	NONE		NONE	NONE~ ()~~~In patient	WA93982	1						1	Pain	FLUX~PFIZER\WYETH~4938145~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058842	01/06/1994	WA	55.0	55		F	11/23/1993	10NOV93 pt c/o (via telephone) about sharp pain stomach & not feeling well; kidney stone & hematuria;									Y	11/08/1993	11/10/1993	2	NA	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	WA93984	1						1	Abdominal pain; Haematuria; Malaise; Pain	FLUX~PFIZER\WYETH~4938145~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058843	01/06/1994	WA	35.0	35		F	11/24/1993	48 hrs p/vax started having joint pain & neck pain x 24 hrs;									Y	11/16/1993	11/18/1993	2	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	WA93985	1						1	Arthralgia; Neck pain	FLU3~PARKE-DAVIS~00763P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0058844	01/06/1994	WA	45.0	45		F	11/23/1993	red, splotchy rash on arms, legs, stomach last nite; today marked myalgias, arthralgias t98.9;				Y					N	11/11/1993	11/18/1993	7	NONE	PVT	PVT	Ibuprofen, AMitriptyline; Multivit & beta carotene, vit E;	NONE		pt exp react w/swine flu;~ ()~~~In patient	WA93986	1						1	Arthralgia; Myalgia; Pyrexia; Rash maculo-papular	FLU3~PARKE-DAVIS~00763P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0058845	01/06/1994	WA	47.0	47		F	11/19/1993	Pt recvd vax 19NOV93 & devel fever, aches, vomiting; wondered if react to vax; talked w/MD prescribed ATB for sinusitis; poss GI virus;				Y					Y	11/17/1993	11/17/1993	0		PUB	UNK				~ ()~~~In patient	WA93987	1						1	Infection; Myalgia; Pyrexia; Sinusitis; Vomiting	FLUX~PFIZER\WYETH~4938145~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058851	01/06/1994	CT	34.0	33		F	12/29/1993	numbness lt side of face 24 hrs (within) 5th cranial nerve inflamation w/in 4 day; hospitalization 1 wk w/treatment of steroids; hospitalization x 12 days gate was off, no temp, fatigue general body weakness; dx MS				Y	Y	12			U	10/24/1993	10/25/1993	1	spinal, & blood work; no ogliclonal banning, sl elevated protein in CSF; no serum, CBC;	MIL	MIL	APAP, Birth control;	sl h/a;	NONE	~ ()~~~In patient		1						1	Asthenia; CSF test abnormal; Gait disturbance; Multiple sclerosis; Neuritis; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~3J41148~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0058859	01/07/1994	AR	0.7	0	.7	F	12/07/1993	mom reports fever of 104 ax during noc of 3NOV93 p/vax MD notified; ran fever 3 noc in a row then fine red rash on abdo & back; MD notified by mom;									Y	11/03/1993	11/03/1993	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	AR9386	1						1	Pyrexia; Rash	DTP~CONNAUGHT LABORATORIES~3A51135~3~IM~RL~DTP (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~3F41032~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0636W~2~IM~LL~HEP B (RECOMBIVAX HB)~1|HIBV~PFIZER\WYETH~M010JN~3~IM~LL~HIB (HIBTITER)~1	USA		Influenza
0058861	01/07/1994	AZ	44.0	44		F	11/08/1993	flu sx, anxiety, drowsiness, fatigue, h/a, pain, tinnitus, SOB, dry mouth, diarrhea, flatulence, myalgia, arthralgia;				Y					Y	10/19/1993	10/20/1993	1	LFT's, CBC, Both WNL-nl;	PUB	PUB				~ ()~~~In patient	AZ9338	1						1	Anxiety; Arthralgia; Diarrhoea; Dyspnoea; Influenza; Myalgia; Somnolence; Tinnitus	FLUX~PFIZER\WYETH~4938186~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058863	01/07/1994	AZ	39.0	39		F	11/03/1993	aching rt upper arm couldn't straighten arm then today red, swollen to elbow, warm to touch; 4NOV93 sx gone;									Y	11/02/1993	11/02/1993	0	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	AZ9346	1						1	Hypokinesia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~4938184~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1042V~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0058864	01/07/1994	AZ	70.0	70		M	11/24/1993	3NOV93 pt recvd vax & 6NOV93 started w/a rash rt arm 1st then lt; rash both arms & back only; itching, red;									Y	11/03/1993	11/06/1993	3	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	AZ9341	1						1	Pruritus; Rash	FLUX~PFIZER\WYETH~49338184~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~330948~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0058870	01/07/1994	MA	18.0	18		M	12/28/1993	bell's palsy (ongoing); loss of reflex (ongoing); progressive muscle weakness resulting in paralysis (two wks progressive, still resolving); blurred vision & h/a; GBS dx;					Y	30			N	11/14/1993	11/25/1993	11	LP, MRI, Electromyography, Lyme disease (neg); Infecuious (neg;);	PVT	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Amblyopia; Facial palsy; Guillain-Barre syndrome; Headache; Hyporeflexia; Myasthenic syndrome; Paralysis; Blindness; Facial palsy; Guillain-Barre syndrome; Hyporeflexia; Hypotonia; Myasthenic syndrome; Paralysis	FLUX~PFIZER\WYETH~4938160~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938160~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0058871	01/07/1994	FL	68.0	68		M	01/03/1994	respiratory failure, usual interstital pneumonia, death;	Y	12/18/1993							N	09/28/1993	12/18/1993	81	Lung biopsy;	PVT	OTH	Lasix, Potassium, Lomadin, Lanoxin;	heart failure;	hx CAD	~ ()~~~In patient		1						1	Apnoea; Pneumonia	FLUX~PFIZER\WYETH~4938088~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~324906~UNK~~~PNEUMO (PNU-IMUNE)~1	USA	Results in Death	Influenza
0058873	01/07/1994	NY	63.0			F		severe local react rt arm secondary to pneumovax; systemic react w/hypotension, dizziness, nausea;					Y						10/07/1993			UNK	UNK	NONE			~ ()~~~In patient		1						1	Dizziness; Hypotension; Injection site reaction; Nausea	FLUX~PFIZER\WYETH~4938152~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~328906~UNK~~~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0058880	01/07/1994	OR	46.0	46		M	11/15/1993	pt had soreness in muscles from balls of wrist up to neck muscle & muscles in rt hand had knot in arm; can be felt but not seen; went to MD;				Y					U	10/15/1993	10/15/1993	0		PUB	PVT				~ ()~~~In patient		1						1	Myalgia; Skin nodule	FLUX~PFIZER\WYETH~4938163~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058881	01/07/1994	MO	23.0	23		F	01/03/1994	27OCT93 lip drooping & eye tearing; water runs out of mouth; dx Bell's palsey;									Y	10/25/1993	10/27/1993	2	NONE	OTH	OTH	NONE	NONE	Meniere's disease & allergies;	NONE~ ()~~~In patient		1						1	Facial palsy; Hypotonia; Lacrimal disorder; Facial palsy; Hypotonia; Lacrimal disorder	FLUX~PFIZER\WYETH~4938186~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938186~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058884	01/10/1994	PA	78.0	78		F	12/29/1993	Nephrotic synd, fever, minimally responsive state;	Y	11/27/1993	Y		Y				N	10/14/1993	10/28/1993	14		OTH	OTH	anticoagulant therapy;		DVT dx'd on 11MAY;		CO5214	1						1	Albuminuria; Blood lactate dehydrogenase increased; Bradycardia; Hypoproteinaemia; Nephrotic syndrome; Sepsis; Shock	FLU3~CONNAUGHT LABORATORIES~3F41124~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0058888	01/10/1994	FL	59.0	59		F	12/22/1993	10NOV93 passed out, not feeling well, shaky, dizzy; 24NOV adm to hosp lt arm pain, chest pain & throat feeling tight; d/c 24NOV; went home dizzy; back to ER 1DEC93;				Y	Y	6	Y		N	11/03/1993	11/10/1993	7	EKG, Echogram, heart cath, gallbladder test;	PUB	PUB	Premarin	felt might be getting something;	NONE	NONE~ ()~~~In patient	FL94002	1						1	Chest pain; Dizziness; Laryngospasm; Malaise; Pain; Syncope; Tremor	FLU3~PARKE-DAVIS~01193P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0058912	01/10/1994	CA	54.0	54		M		demyelinating polyneuropathy; bilateral carpal tunnel synd w/o axonal loss to either abdo poll brev; dx GBS versus chronic inflammatory polyneuropathy;				Y					N	10/15/1993	11/05/1993	21	abn NCS/EMG other tests WNL or neg;	PVT	PVT	NONE	NONE	hx psotiasis	~ ()~~~In patient		1						1	Guillain-Barre syndrome; Laboratory test abnormal; Neuropathy; Tenosynovitis	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0058913	01/10/1994	VA	37.0	37		M	12/06/1993	pale, warm & clammy, diaphoretic, shakey, nauseated w/in 4-6 mins p/vax; pt given DPh & observed x  1 3/4 hrs;				Y					Y	10/12/1993	10/12/1993	0		PVT	UNK		NONE	allergic to phenoditine, EES	UNK~ ()~~~In patient		1						1	Hyperhidrosis; Nausea; Pallor; Tremor; Vasodilatation	FLUX~PFIZER\WYETH~4938084~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058914	01/10/1994	VA	32.0	32		F	12/06/1993	redness, swelling, itching, hot to touch; pt given DPH & advised to take DPH;				Y					Y	10/20/1993	10/20/1993	0		PVT	UNK		NONE	No known problesm;	UNK~ ()~~~In patient		1						1	Oedema; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~4938084~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058917	01/10/1994	MA	52.0	52		F	01/03/1994	pt recvd vax 19OCT93 & 2-3 days post vax exp pain @ site of inject; pain worsened when tried to raise lt arm to brush teeth, etc;									N	10/19/1993	10/21/1993	2		PUB	PUB	NONE	NONE	had problem w/breathing p/being injected w/Iodine for gall bladder studies @ age 25 yrs;	~ ()~~~In patient		1						1	Injection site pain	FLUX~PFIZER\WYETH~4938083~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058922	01/10/1994	MD	36.0	36		F	10/29/1993	local rxn-red & itching @ site of inject lt deltoid lateral;									Y	10/07/1993	10/07/1993	0		OTH	UNK		NA		~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~4938084~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0058923	01/10/1994	MD	50.0	50		U		c/o itching & heat @ site of vax lt deltoid; no hives noted; some warmth to touch over inject site; denies further sx; devel SOB, mild dyspnea & cough;									Y	10/08/1993	10/08/1993	0		OTH	OTH		NA	PCN, Asthma, hx of sarcoid	~ ()~~~In patient		1						1	Cough; Dyspnoea; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4938083~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0058924	01/10/1994	MD	21.0	21		U		vaso vagal syncope; pt had lightheaded react 5 mins p/vax; no witnessed sz acitivty; felt like passing out when stood up;;									Y	10/08/1993	10/08/1993	0		OTH	OTH	Birth control pills	NA		~ ()~~~In patient		1						1	Dizziness; Hypotension; Syncope	FLU3~CONNAUGHT LABORATORIES~4938084~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0058925	01/10/1994	MD	38.0	38		U		c/o redness to lt deltoid-site of flu vax; no itching; lumpy feeling @ site of vax; ice pack to site;									Y	10/06/1993	10/06/1993	0		OTH	UNK		NA	h/a; PVC's, MVP;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~4938084~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0059794	01/10/1994	MN	59.0	59		F	12/22/1993	rapid onset of achiness & weakness of hips & legs accompanied by fever & chills; pt taken to ER dx as influenza but not the type that flu shot takes care of;				Y					Y	10/21/1993	11/09/1993	19	CXR neg for pneumonia;	PUB	PUB	Vitamin B12	NONE	vitamin B12 defiency	~ ()~~~In patient	MN93071	1						1	Arthralgia; Chills; Influenza; Myalgia; Myasthenic syndrome; Pyrexia	FLUX~PFIZER\WYETH~4938142~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0059795	01/10/1994	MN	58.0	58		F	11/08/1993	29OCT93 devel aching, chills, & cough seen by MD later that day; dx as viral illness & cough medicine w/codeine prescribed; 8NOV cont to have same sx spoke w/MD today; no change in treatment ordered;									N	10/27/1993	10/29/1993	2	NONV	PUB	PUB	Lanoxin, ASA, Ogen	NONE	atrial fibrillation	~ ()~~~In patient	MN93072	1						1	Chills; Cough; Infection; Myalgia	FLUX~PFIZER\WYETH~4938142~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059797	01/10/1994	MN	7.0	7		M	11/18/1993	started wheezing w/cont cough about 7PM on 16NOV93; nebulizer treatment w/rellief of sx; wheezing & coughing began again morning of 17NOV93; short term relief w/nebulizer; seen by MD 17NOV; inc frequency of nebulizer treatments @ that time;				Y					U	11/16/1993	11/16/1993	0		PUB	PUB	Proventil & Intal	NONE	asthma	~ ()~~~In patient	MN93074	1						1	Asthma; Condition aggravated; Cough	FLUX~PFIZER\WYETH~4938142~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0059807	01/10/1994	MN				F	11/15/1993	pt recvd vax felt tired out next 3 days & by the 4th day devel sore throat, temp & cold sx; arm got a red blotch that stung & then got itchy & a sugary, watery scab formed; also red blotches on 4th day; not feeling well;									Y	11/04/1993				OTH	OTH		NONE		~ ()~~~In patient		1						1	Asthenia; Malaise; Pain; Pharyngitis; Pruritus; Pyrexia; Rash maculo-papular; Rhinitis	FLUX~PFIZER\WYETH~3F41034~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058933	01/11/1994	CO	74.0	74		M	12/10/1993	Guillian Barre Synd;				Y	Y	15	Y		Y	10/14/1993	10/22/1993	8		PUB	PUB		NONE	CA of colon w/resection (history); Caranoid synd heart problems;	~ ()~~~In patient	CO93094	1						1	Guillain-Barre syndrome; Guillain-Barre syndrome; Hypokinesia; Myasthenic syndrome; Neck pain; Pain; Paraesthesia	FLU3~PARKE-DAVIS~00973P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLUX~PFIZER\WYETH~4938157~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0058934	01/11/1994	CO	35.0	35		M	12/28/1993	inflamation, pain, restricted motion; rx started w/Motrin, changed to Codeine & APAP, PT;				Y					N	11/01/1993	11/01/1993	0		PVT	PVT				~ ()~~~In patient	CO93095	1						1	Hypokinesia; Pain; Monoplegia; Pain	FLU3~CONNAUGHT LABORATORIES~3F41027~4~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~3F41007~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0058938	01/11/1994	GA	29.0	29		M	11/24/1993	20OCT Encephalopathic w/progressively inc lethargy, gait unsteadiness, dysphagia & anorexia; low grade fever x 1 wk;					Y				U	10/08/1993	10/20/1993	12	EEG unchanged, drug levesl unchanged or lower CSF nl, CT & MRI head unchanged serum chemistries, lactate; CXR questionable infiltrate;	PUB	UNK	Depakote, Dilantin		Intractible epilepsy, mental retardation;	~ ()~~~In patient		1						1	Anorexia; Dysphagia; Encephalopathy; Gait disturbance; Laboratory test abnormal; Pyrexia; Somnolence	FLUX~UNKNOWN MANUFACTURER~4938151~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0058950	01/11/1994	VA	29.0	29		F	10/26/1993	approx 10 mins p/shot pt became diaphoretic, weak, w/c/o tingling in neck & face & tightness in chest; pt was given DPH;				Y					Y	10/26/1993	10/26/1993	0		PVT	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Asthenia; Chest pain; Hyperhidrosis; Paraesthesia	FLUX~PFIZER\WYETH~4938084~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058951	01/11/1994	MD	65.0	65		F	10/20/1993	c/o lightheadedness 10 mins p/vax; BP 124/74; HR 68+ reg VSS; BP 120/60 HR 60 & reg; pt states feeling better									Y	10/06/1993	10/06/1993	0	BP 124/74 pulse 68 red; 10 mins p/inject 120/60 pulse 60 reg;	OTH	UNK		NA	LBD, Chronic HA, lactose intollirance, IBS	~ ()~~~In patient		1						1	Dizziness	FLU3~CONNAUGHT LABORATORIES~4938084~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0058953	01/11/1994	WA	56.0	56		F	01/03/1994	flushed feeling & pressure in head; BP elevated to 184/92 (nl is 100-120/70-80; BP dec p/45 mins to 126/76; fine remainder of day; pt reported no anxiety about vax									Y	11/01/1993	11/01/1993	0	NONE	OTH	PVT	Estorgen patch	NONE	NONE	NONE~ ()~~~In patient		1						1	Headache; Hypertension; Vasodilatation	FLU3~PARKE-DAVIS~00763P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0058954	01/11/1994	VA	34.0	34		F	11/04/1993	diaphoretic, nauseous, weak, shakey;									Y	10/19/1993	10/19/1993	0	NA	OTH	OTH	NA	NONE	NONE	NA~ ()~~~In patient		1						1	Asthenia; Hyperhidrosis; Nausea; Tremor	FLUX~PFIZER\WYETH~4938084~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058965	01/13/1994	MI	41.0	41		M	01/08/1994	2 days following vax pt exp sz like activity x 3 episodes; pt was in ICU x 3 days; hospitalized x 4 days;			Y	Y	Y	4			Y	10/23/1993	10/25/1993	2	EEG neg; all labs neg;	MIL	MIL	Motrin	NONE	NONE	NONE~ ()~~~In patient		1						1	Convulsion	FLU3~CONNAUGHT LABORATORIES~3O41148~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0057931	01/14/1994	MI	65.0	65		M	12/09/1993	28OCT93 difficulty controlling movement lt hand & arm; 29OCT93 noted swelling in lt arm pit; hard to lift arm above head; bruising blue color indicates inner aspect of upper lt arm;				Y					N	10/27/1993	10/28/1993	1	NONE	PUB	PUB	Zantec; Motrin;	1992 shunt from brain for spinal fluid	NKA H. Hernia & gas	~ ()~~~In patient	MI93175	1						2	Ecchymosis; Hypokinesia; Movement disorder; Oedema	FLUX~PFIZER\WYETH~4938142~3~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0093W~1~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0058961	01/14/1994	VA	58.0	58		F	12/28/1993	lt shoulder became sore @ once last wk of OCT93; It hurts to lift arm; hurts @ noc while sleeping; aching feeling; arthritis has never been this way; pain has never gone away since it first began;										10/14/1993	10/26/1993	12		MIL	UNK		NONE	some arthritis/allergy in nostrils/Grandula dystrophy;	~ ()~~~In patient		1						1	Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~3J41026~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0059082	01/14/1994	FL	57.0	57		M	12/21/1993	16DEC93 pt recvd vax 16DEC93 1620 & 1625 c/o dizziness, nausea, diaphoresis; denied resp difficulty, pruritus or rashes-BP 110/70, HR 80; 1635 vomiting-resp status unchanged & no rashes/hives; 1640 refused DPH; 1645 BP 122/80 HR 88;									Y	12/16/1993	12/16/1993	0	NONE	PUB	PUB	Denied	denied	Denied	pt exp dizziness, nausea p/prev immun;~ ()~~~In patient	FL94003	1						1	Dizziness; Hyperhidrosis; Nausea; Vomiting	FLUX~PFIZER\WYETH~4938217~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059083	01/14/1994	MI	83.0	83		M	11/16/1993	pt claims cont to have pain of shoulder lt upper arm, not elbow lower arm & middle/ring finger lt hand;									N	10/05/1993	10/05/1993	0	NONE	PUB	PUB	Denied	Denied	hx heart problem under no specific meds time of immun;	denied~ ()~~~In patient	MI93168	1						1	Injection site pain; Pain	FLUX~PFIZER\WYETH~4938142~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059087	01/14/1994	MI	48.0	48		F	10/08/1993	6OCT93 pt recvd vax & lt arm swollen- 7OCT93 w/redness; fever 100-101 6OCT92; t100 7OCT93 & reported some diarrhea; subsided by itself;									Y	10/06/1993	10/07/1993	1		PUB	PUB		NONE		~ ()~~~In patient	MI93173	1						1	Diarrhoea; Oedema peripheral; Pyrexia; Vasodilatation	FLUX~PFIZER\WYETH~44938183~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059088	01/14/1994	MI	30.0	30		F	10/08/1993	h/a, rt arm hurting, sluggish, chills/sweats started late in day of shot & was full blown by next AM;									Y	10/05/1993	10/05/1993	0		PUB	PUB		NONE	sinusitis (seasonal);	~ ()~~~In patient	MI93174	1						1	Chills; Headache; Hyperhidrosis; Hypokinesia; Pain	FLUX~PFIZER\WYETH~4938183~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059090	01/14/1994	MI	72.0	72		F	11/10/1993	w/in 72 hrs c/o nausea, loss of appetite, palms of hands red for short period; denies fever;									U	10/26/1993	10/28/1993	2	NONE	PUB	PUB	Premarin; Tenormin;	flu like sz;	No known allergy;	NONE~ ()~~~In patient	MI93176	1						1	Anorexia; Asthenia; Cough; Nausea; Vasodilatation	FLUX~PFIZER\WYETH~4938142~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059091	01/14/1994	MI	74.0	74		M	11/18/1993	c/o aches & pain 9 days post vax; 18NOV93 pt stated was taking  radiation therapy for prostate cancer daily;									Y	10/14/1993	10/23/1993	9	NONE	PUB	PUB	Coumadin & Lanoxin	CA of prostate on radiation	CA of prostate-on radiation therapy; diarrhea	NONE~ ()~~~In patient	MI93177	1						1	Myalgia; Pain	FLUX~PFIZER\WYETH~4938142~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059093	01/14/1994	MI	69.0	69		F	12/01/1993	severe chills approx 1 wk p/vax followed by rash-red dime size blotches (not raised) over chest, hips, then legs 7 arms spreading together, itchy but not painful; lethargy, lack of appetite lasting 2 wks;									N	11/19/1993	11/26/1993	7	NONE	PUB	PVT		NONE	allergic to sulfur	NONE~ ()~~~In patient	MI93179	1						1	Anorexia; Chills; Pruritus; Rash maculo-papular; Somnolence	FLUX~PFIZER\WYETH~4938178~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059101	01/14/1994	TX	64.0			M	11/10/1993	felt lower lip swollen 20 mins p/flu vax; BP 124/80, P48; DPH given;									Y					UNK	UNK			hx of allergy to PCN	~ ()~~~In patient	TX93237	1						1	Face oedema	FLU3~CONNAUGHT LABORATORIES~3F41009~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0059118	01/14/1994	NJ	57.0	57		F	11/24/1993	sudden swelling @ site of inject 5 cm induration; no systemic rxn DPh given;									Y	11/16/1993	11/16/1993	0	NONE	PVT	PVT	?denied	NONE	lanyngeal CA; emphysema;	unk~ ()~~~In patient		1						1	Injection site mass; Injection site oedema; Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~3F41132~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~3F41132~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0059120	01/18/1994	AZ	62.0	62		F	12/21/1993	pt recvd flu vax 28NOV93 & approx 14DEC93 began to devel sx of GBS; remains hospitalized as the date of this report in stable condition;	Y				Y				N	11/28/1993	12/11/1993	13		OTH	PVT	unk	unk	hx of labile hypertension, uterine cancer--rx'd in 1975, hysterectomy, osteoporosis, acute herniated disc--rx'd w/epidural blocks; allergic to sulfa drugs & possibly Demerol;	~ ()~~~In patient	893357001J	1						1	Asthenia; Cardiovascular disorder; Dysphagia; Dyspnoea; Guillain-Barre syndrome; Neck pain; Neuropathy; Paraesthesia	FLUX~PFIZER\WYETH~4938278~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0059126	01/18/1994	IL	69.0	68		F	11/23/1993	pt recvd vax 16NOV93 & exp pain @ inject site; 3-4 hrs later intense pain; tenderness @ biceps tendon & humeral groove; tx'd w/IV solu-Medrol; sx worse (pain radiating from arm to lt neck & chest wall); neuritis; melena; stool was guiac pos					Y	3			U	11/16/1993	11/16/1993	0	physiatrist: neuritis, not muscle or joint related;	PVT	PVT	NA		chronic obstructive pulmonary disease; Hypertension; no hx of pneumonia;	NA~ ()~~~In patient	930252501	1						1	Chest pain; Gastric ulcer; Injection site pain; Laboratory test abnormal; Melaena; Neck pain; Neuritis; Pain; Gastric ulcer; Haematemesis; Injection site pain; Laboratory test abnormal; Neuritis	PPV~PFIZER\WYETH~364982~1~IM~LA~PNEUMO (PNU-IMUNE)~1|FLUX~PFIZER\WYETH~4938262~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~PFIZER\WYETH~364982~1~IM~LA~PNEUMO (PNU-IMUNE)~2	USA	Hospitalisation	Influenza
0059129	01/18/1994	CA	62.0	62		M	11/24/1992	18NOV devel ha & general malaise w/sl elevated temp;									U	11/10/1992	11/18/1992	8		PUB	UNK		NONE	NONE	~ ()~~~In patient	CA94003	1						1	Headache; Malaise; Pyrexia; Headache; Malaise; Pyrexia	FLUX~PFIZER\WYETH~4928219~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928219~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0059132	01/18/1994	CA	80.0	79		F	11/02/1992	redness, swelling the size of injection;									Y	10/29/1992	10/29/1992	0		PUB	UNK	NONE	NONE	NONE	~ ()~~~In patient	CA94006	1						1	Injection site hypersensitivity; Injection site oedema; Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4928219~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928219~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0059136	01/18/1994	CA	78.0	77		M	11/08/1993	very angry; states recvd vax & exp high fever-100.7;										11/04/1993	11/05/1993	1		UNK	PUB		Denies		~ ()~~~In patient	CA94010	1						1	Hostility; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059150	01/18/1994	MD	45.0	45		M	10/25/1993	15OCT93 pain @ site; lt brachial plexus neuropathy; 17OCT93 pain in lt arm, neck, tips of fingers;				Y					N	10/13/1993	10/15/1993	2	NONE	PUB	PUB	Capoten, Lozol	hypertension	hypertenison	NONE~ ()~~~In patient	MD93044	1						1	Injection site pain; Neck pain; Neuropathy; Pain; Paraesthesia	FLU3~PARKE-DAVIS~00193P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0059151	01/18/1994	MD	57.0	57		F	10/14/1993	Pt recvd vax & 1 wk later exp sore throat, could hardly talk, fever; seen by MD 12OCT who said was not related to flu vax; given a prescription for Emycin, Demacol; exp aching, cough, fever 101.5;				Y					U	10/04/1993	10/11/1993	7		PUB	PVT	NONE	NONE	allergy to Sulfa drugs (hives);	NONE~ ()~~~In patient	MD93048	1						1	Chills; Cough; Diarrhoea; Myalgia; Pharyngitis; Productive cough; Pyrexia; Speech disorder; Chills; Cough; Diarrhoea; Malaise; Myalgia; Pharyngitis; Pyrexia; Vasodilatation	FLUX~PFIZER\WYETH~4938178~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938178~5~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0059156	01/18/1994	CA	78.0	78		M	01/04/1994	pt was given flu vax 1OCT93 & w/in 1 wk devel sx of GBS w/resp failure requiring ventilator support & 3 heart blocks requiring pacemaker; pt devel complication of pneumonia later on ventilator & died secondary to sepsis w/in wks;	Y		Y		Y				N	10/01/1993	10/01/1993	0		UNK	UNK			Ocular Myasthenia Gravis (only Ocular); DIabetes; hypertension;	~ ()~~~In patient		1						1	Apnoea; Atrioventricular block complete; Guillain-Barre syndrome; Pneumonia; Respiratory disorder; Sepsis	FLU3~CONNAUGHT LABORATORIES~3F41142~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0059158	01/18/1994	NJ	15.0	15		F	12/30/1993	45 mins post inject fell asleep to the following afternoon (12PM) & again until 530PM; 530PM on 27OCT93 noticed: redness, swelling & tenderness @ the inject site achiness, over entire body; ice applied to inject site, APAP given;				Y					Y	10/26/1993	10/26/1993	0	CBC, Mononucleosis-neg results;	PVT	PVT	NONE	NONE	asthma	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia; Somnolence	FLU3~CONNAUGHT LABORATORIES~3F41141~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0059161	01/19/1994	WV	75.0	75		F	12/14/1993	h/a; inc temp (sl); aching; lung congestion; has had sx since recvd flu vax; seen by MD;				Y					Y	10/21/1993	10/22/1993	1		PUB	UNK		NONE		~ ()~~~In patient	WV9337	1						1	Headache; Lung disorder; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41008~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0059172	01/19/1994	MA	77.0	77		F	01/06/1994	eyes roll up then come back down; inc body rigidity; eyes blood shot; lethargic, cries out in discomfort; v/s t97.9 R; BP 98/62; P67; R20									Y	10/26/1993	10/26/1993	0		OTH	PUB	Thyroxine; Haldol; Cogentin; Despramine; DPH;	schizophrenia depression	? allergy to Bactrim; schizophrenia, depression;	~ ()~~~In patient		1						1	Agitation; Conjunctivitis; Gaze palsy; Hypertonia; Pain; Somnolence	FLUX~PFIZER\WYETH~4938083~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059184	01/20/1994		34.0			M	01/10/1994	severe occipital HA, severe shaking, fever 102-103, tachypnea; tx EPi, Methylpred, DPH;				Y					U	01/10/1994	01/10/1994	0	NONE	UNK	UNK		NONE	NONE			1						1	Headache; Hyperventilation; Pyrexia; Tremor	FLU3~CONNAUGHT LABORATORIES~3J41144~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~PFIZER\WYETH~4938134~UNK~IM~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0041964	01/24/1994	CA				M	01/03/1994	Pt recvd vax in 1991 & on 6NOV91 devel GBS; pt was hospitalized twice as a result of this adverse react, & cont to exp lower leg problems, weakness & loss of stamina;			Y		Y			Y	N		11/06/1991			PUB	PUB	unk	unk	unk	unk~ ()~~~In patient	894005001J	1						2	Asthenia; Guillain-Barre syndrome; Asthenia; Guillain-Barre syndrome	FLUX~PFIZER\WYETH~4918169~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~PFIZER\WYETH~285909~UNK~~~PNEUMO (PNU-IMUNE)~2|FLUX~PFIZER\WYETH~4918169~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|PPV~PFIZER\WYETH~285909~UNK~~~PNEUMO (PNU-IMUNE)~3	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0059203	01/24/1994	CA	71.0	71		F	11/23/1993	itching on lt arm, elbow, swelling red, hot not able to move very painful;					Y	3			Y	11/16/1993	11/16/1993	0		PUB	PUB	Amoxicillin	NONE		~ ()~~~In patient	CA93116	1						1	Hypokinesia; Oedema peripheral; Pain; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~4938148~3~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~358958~2~~LA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0059204	01/24/1994	CA	64.0	64		F	12/20/1993	2 hrs p/inject pt rt arm was painful to touch w/movement; large induration & erythema; states felt had a fever but is undocumented; assessed by MD next day was given Atarax; states arm sore only;				Y					Y	12/14/1993	12/14/1993	0	NONE	PUB	PUB		NONE	NONE	~ ()~~~In patient	CA93117	1						1	Myalgia; Pain; Pyrexia; Rash; Skin nodule	FLUX~PFIZER\WYETH~4938142~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~358958~1~IM~RA~PNEUMO (PNU-IMUNE)~1|TD~LEDERLE LABORATORIES~356904~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0059206	01/24/1994	CA	18.0	18		F	10/22/1993	c/o pain @ site last evening 21OCT93; raised red patch @ site 77mm c 38mm, hot to touch, painful;									U	10/21/1993	10/22/1993	1	NONE	OTH	PUB		NONE	allergic molk of allergy to spinal anesthia w/C-section;	NONE~ ()~~~In patient	CA93119	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLUX~PFIZER\WYETH~4938142~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059207	01/24/1994	CA	28.0	28		F	12/20/1993	fever 102, earache, sore throat, chills, malaise, aching muscles, red stiff arm, vomiting; pt states felt ill for 2 wks but did not seek care;									Y	10/05/1993	10/05/1993	0	NONE	OTH	PUB		mild sore throat, fever, malaise	1 wk prior seen by MD for sinusitis-Vantin	NONE~ ()~~~In patient	CA93120	1						1	Chills; Condition aggravated; Ear pain; Hypertonia; Myalgia; Pyrexia; Vasodilatation; Vomiting	FLUX~PFIZER\WYETH~4438142~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~358958~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0059208	01/24/1994	CA	83.0	83		F	12/02/1993	21NOV93 weakness, prostration, vomiting, cold hands, muscle aches & pains; husband gave VICODIN to relieve aches;									Y	10/22/1993	11/21/1993	30		OTH	PUB		NONE		~ ()~~~In patient	CA93122	1						1	Asthenia; Myalgia; Pain; Peripheral vascular disorder; Vomiting	FLUX~PFIZER\WYETH~4938148~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059209	01/24/1994	CA	72.0	72		F	11/24/1993	pt recvd vax 20OCT93 & 14NOV devel fever 103, aches, ha/ severe chills (body shook);									Y	10/20/1993	11/14/1993	25		OTH	OTH	Cartilem, diazide, Novasic, premarin, Asthanacort	NONE	high blood pressure, asthma;	pt exp rxn everytime gets flu vax;~ ()~~~In patient	CA93123	1						1	Chills; Headache; Myalgia; Pyrexia; Tremor	FLUX~PFIZER\WYETH~4938148~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059210	01/24/1994	CA	85.0	85		M	12/02/1993	21NOV93 muscular aches & pains, no fever, diarrhea & GI tract upset; took Vicodin 21NOV & felt better;									Y	10/22/1993	11/21/1993	30		OTH	PUB		NONE		~ ()~~~In patient	CA93128	1						1	Diarrhoea; Dyspepsia; Myalgia; Pain	FLUX~PFIZER\WYETH~4938148~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059216	01/24/1994	MT	43.0	43		F	01/03/1994	had flu sx middle of December fever-aching (viral like); numbness, soreness tingling 1DEC93; lost motor control of both feet & rt hand 24DEC93  pain-anorexia; seen by MD; GBS:					Y	35			U	11/10/1993	12/01/1993	21		PUB	PUB	Proventil inhaler; Asmacort inhaler;	NONE	allergies to mold & trees;	~ ()~~~In patient	MT94002	1						1	Anorexia; Guillain-Barre syndrome; Infection; Influenza; Movement disorder; Myalgia; Paraesthesia; Pyrexia	FLU3~PFIZER\WYETH~22436C~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation	Influenza
0059249	01/25/1994	MO	71.0	71		F	12/15/1993	hospitalized for pneumonia 2 wk p/shot;					Y				Y	10/25/1993	11/02/1993	8		PUB	PUB		NONE	NONE	~ ()~~~In patient	MO94005	1						1	Pneumonia	FLU3~CONNAUGHT LABORATORIES~3F41124~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0059270	01/25/1994	WA	49.0	49		F	01/18/1994	severe myalgias, fever, w/subsequent weakness/pain of lt upper & lower extremities; progressive weakness w/muscle atorphy; sx began 48 hrs p/vax;				Y				Y	U	11/24/1993	11/26/1993	2	WBC 13.6; plt 485K; ESR 36; CPK, SOGT-nl EMG nerve conduction-nl;	PVT	PVT	Ogen, Provera	NONE	NONE	~ ()~~~In patient		1						1	Leukocytosis; Muscle atrophy; Myalgia; Myasthenic syndrome; Pain; Pyrexia; Red blood cell sedimentation rate increased; Thrombocythaemia	FLUX~PFIZER\WYETH~4938280~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0059273	01/25/1994	NM	39.0			F	11/01/1993	20 mins p/vax chills, n,v, & h/a w/in 60 mins; also soreness @ inject site rt deltoid (no erythema or pruritus) & myalgia rt elbow & rt wrist; inject site-4.5 cm induration x 2 days; also hot/cold & nasal congestion;									Y	10/26/1993	10/26/1993	0	NA	PUB	PUB	NA	NA	NA	~ ()~~~In patient		1						1	Chills; Headache; Injection site mass; Injection site pain; Myalgia; Nausea; Rhinitis; Vomiting	FLUX~PFIZER\WYETH~4938125~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059274	01/25/1994	NM	29.0			F	11/01/1993	burning discomfort @ site @ time  of inject-redness, heat tenderness @ site beginning few hrs later & increasing in size x days; On PM of inject felt lethargic & feverish also for several hrs; mild diffuse induration;									Y	10/19/1993	10/19/1993	0	NA	PUB	PUB	Advil/APAP	NA	NA	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Pyrexia; Somnolence; Vasodilatation	FLUX~PFIZER\WYETH~4938125~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059279	01/25/1994	TX	31.0	30		F	01/19/1994	cont soreness in the lt deltoid since inject; small lump noted by palpation @ inject site;									N	10/13/1993	10/14/1993	1		PVT	PVT	NONE	NONE	hep A @ age 8	~ ()~~~In patient		1						1	Injection site mass; Injection site pain; Injection site mass; Injection site pain	FLUX~PFIZER\WYETH~4938144~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938144~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0059281	01/26/1994	AL	59.0	59		F	11/15/1993	pt recvd vax & pt did not feel well; denies chest pain; phone call from family @ 345; pt having trouble breathing; instructed to call 911 or transport to ER arrived ER 444PM; PO2 48.8, Co2 46.0; K 3.3; creact 5; resp sx cont to worsen;	Y	10/28/1993							N	10/28/1993	10/28/1993	0	COD cardiorespiratory arrest secondary dx CVA, arrythmia; K-3.3; Creat 0.5; WBC 9.6; HCT 39.0; PO2 48.8; PC02 46.0;	OTH	PUB		diabetes, hypokalema, COPD, old CVA	diabetes, hypokalemia, COPD, old CVA;	~ ()~~~In patient	AL9353	1						1	Apnoea; Arrhythmia; Cardiac arrest; Cerebrovascular accident; Dyspnoea; Hypokalaemia; Hypoxia; Malaise	FLUX~PFIZER\WYETH~4938149~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0059282	01/26/1994	AL	39.0	39		M	12/09/1993	pt stated pneumonia shot hurts from shoulder to elbow; denied any problem w/flu vax; pneumonia vax area is swollen; 26OCT93 ER MD told pt arm was infected & gave medication;				Y					Y	10/21/1993	10/22/1993	1		PUB	PUB		denied any	NKA	~ ()~~~In patient		1						1	Infection; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~4938182~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0439W~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0059294	01/27/1994	CA	28.0	28		F	01/17/1994	erythema/rash upper lt arm w/clear drainage; Itching of affected area; Onset 24 hrs p/administration of vaccine; dx by MD as acute allergic dermatitis;				Y					Y	10/05/1993	10/06/1993	1	NONE	OTH	OTH	NONE	NONE	known mild react (localized rash) w/PPD (Mantoux);	~ ()~~~In patient		1						1	Hypersensitivity; Injection site hypersensitivity; Pruritus	FLUX~PFIZER\WYETH~4938156~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0059297	01/27/1994	MA	67.0	67		M	01/18/1994	pt began feeling extremely weak & tired about 2 wks p/vax was administered-lasted about 3 wks;									Y	10/22/1993	11/05/1993	14	NONE	OTH	UNK	Theophylline, Trental, Verapamil, Lasix, Prednisone, Lanoxin, Coumadin, Kaochlor, Nebulizer: Metp		IVP dye, Macrodantin	NONE~ ()~~~In patient		1						1	Asthenia	FLU3~CONNAUGHT LABORATORIES~3F4103~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0059305	01/27/1994	KS	49.0	49		F	12/07/1993	P/receiving flu vax pt c/o tingling & numbness in lt arm & leg; reluctant to seek medical care; denies h/a, dyspnea, or visual disturbances; recommended primary care MD visit which finally complied with; supervisor drove to primary care MD;				Y					Y	10/21/1993	10/21/1993	0		OTH	PUB	NONE	NONE	Iodine, Codeine	~ ()~~~In patient	KS93058	1						1	Chest pain; Hypersensitivity; Hypertension; Injection site pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~3F41114~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0059307	01/27/1994	KS	56.0	56		F	11/01/1993	25OCT93 430PM tired, felt funny, sore arm & swollen from shoulder to elbow;  26OCT93 lt work a/noon-collapsed & slept rest of day-awoke w/fever @ 10PM 104 called MD 1030PM; took APAP & Advil; 27OCT93 joints hurt, h/a, arm swollen & painful;									Y	10/25/1993	10/25/1993	0		PUB	PUB	Tenex, Treodur, Allopurinol, Seldane, Progesterone, Estrogen;	NONE	allergies Airborne & strawberries & honeydew melon; Asthma since childhood;  High BP-controlled by Tenex;	~ ()~~~In patient	KS93060	1						1	Arthralgia; Asthenia; Headache; Injection site oedema; Myalgia; Pyrexia; Somnolence; Syncope	FLU3~CONNAUGHT LABORATORIES~3F41114~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~356967~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0059323	01/28/1994	MS	61.0	61		M	11/03/1993	1145PM flu vax recvd; 16mm knot arose @ inject site-non tender; pt x 15mins; in no distress, BP 150/98-lt office; returned @ 440PM, knot still a site; non tender-no pain according to MD;									Y	11/01/1993	11/01/1993	0	NONE	PUB	PUB	gout med, name unk	NONE	NONE	NA~ ()~~~In patient	MS93058	1						1	Injection site mass	FLU3~CONNAUGHT LABORATORIES~3F41029~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0059339	01/31/1994	CO	65.0	65		M	01/10/1994	Pt was awakened the morning following the vax w/ringing in the ears; no dizziness or hearing loss; Is present at all times but worse at noc;				Y						10/26/1993	10/27/1993	1	hearing-WNL;	PUB	PUB	NONE	NONE	allergy to PCN & sl allergy to MSG;	NONE~ ()~~~In patient	CO94001	1						1	Tinnitus	FLU3~PARKE-DAVIS~00973P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~0093W~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0059340	01/31/1994	HI	46.0	46		F	01/18/1994	pt states woke up 4NOV93 w/hives all over body, skin was red & c/o itch; 5NOV93 went to ER & was told to see pvt MD; cont skin rash; 11NOV93 to ER c/o feeling hot & cold, difficulty breathing & swelling to face, arms, legs & face; blisters;				Y					Y	11/03/1993	11/04/1993	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	HI941	1						1	Dermatitis bullous; Dermatitis exfoliative; Dyspnoea; Face oedema; Oedema peripheral; Photosensitivity reaction; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~3F41001~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0059343	01/31/1994	ID	60.0	60		F	10/28/1993	severe stomache pain 22OCT93 PM; sl fever 22OCT93-27OCT93; uncontrollable & shakes 23OCT93;				Y					Y	10/22/1993	10/22/1993	0		PUB	PUB	NOE			NA~ ()~~~In patient	ID93089	1						1	Abdominal pain; Chills; Pyrexia; Tremor	FLUX~PFIZER\WYETH~493226~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0059345	01/31/1994	ID	64.0	64		F	10/28/1993	swelling in throat, feels like mouth is broken out on roof of mouth; 27OCT93 ear running & hurting; PMD treated w/Advil, pred, Tetracycline, Chlorpheniramine maleate & some shot; 1NOV93 pt tired;				Y					Y	10/19/1993	10/24/1993	5		PUB	PUB		NONE	celery, strawberry & dry noodle mix allergy PNC;	~ ()~~~In patient	ID93091	1						1	Ear pain; Laryngospasm	FLUX~PFIZER\WYETH~4938226~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0059347	01/31/1994	ID	55.0	55		F	11/01/1993	1030AM flu shot given lt clinic; returned 1130AM stated hands itching & throat feels like itching & swelling-refused DPH shot;									Y	10/27/1993	10/27/1993	0		PUB	PUB		NONE	some ATB, dust, somke, pollens, grasses, weeds;	~ ()~~~In patient	ID93093	1						1	Laryngospasm; Pruritus	FLUX~PFIZER\WYETH~4938226~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059348	01/31/1994	ID	77.0	77		F	11/09/1993	Pt called 2NOV93 to state had pains in the back of legs starting 1-2 days p/flu vax, referred to PMD on 9NOV93; pt devel joint inflamation as a direct result of vax;				Y					U	10/22/1993	10/23/1993	1		PUB	OTH	NONE	NONE	hx of eczema	~ ()~~~In patient	ID93094	1						1	Arthritis; Pain	FLUX~PFIZER\WYETH~4938226~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0059350	01/31/1994	ID	65.0	65		F	11/19/1993	20OCT became ill, chills, fever, aches, pains (highest 101) 5PM; felt weak, tired, achey x 3 wks p/vax; seen by MD 25DEC93; dx w/influenza from the vax;				Y					Y	10/19/1993	10/20/1993	1		PUB	PUB	NONE	NONE		~ ()~~~In patient	ID93096	1						1	Asthenia; Chills; Drug ineffective; Infection; Influenza; Myalgia; Pain; Pyrexia	FLUX~PFIZER\WYETH~4938226~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0059353	01/31/1994	ID	20.0	20		F		hurt to move, muscles were sore through-out body; hurt to swollow; lasted for about 3 days;									Y	10/08/1993	10/10/1993	2		OTH	UNK		NONE	NONE	~ ()~~~In patient	ID93099	1						1	Dysphagia; Myalgia; Pain	FLUX~PFIZER\WYETH~4938163~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059354	01/31/1994	ID	1.7	1	.7	F	12/09/1993	5NOV93 episodes of vomiting start in AM cont throughout day; 6NOV93 taken to ER saw MD for dehydration; 7NOV92 sl elevated temp noted, some episodes of vomiting; 8NOV93 seen by MD no dehydration noted-MD stated viral not vax related;				Y					Y	11/03/1993	11/05/1993	2	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	ID93100	1						1	Dehydration; Infection; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~3F41029~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0059355	01/31/1994	ID	2.0	2	.9	F	11/24/1993	fever x 24 hrs; vomiting x 6 hrs; consulted w/MD who said due to vax because of pt's age;				Y					Y	11/15/1993	11/18/1993	3		PUB	PUB	NA	NA	asthma; allergy to Amoxicillin	NA~ ()~~~In patient	ID93101	1						1	Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~3F41029~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0059356	01/31/1994	ID	76.0	76		F	11/24/1993	fever 102 oral; pneumonia dx on 1DEC93 took ATB & pred & now on 02 @ home;				Y	Y				Y	11/17/1993	11/21/1993	4		PUB	PUB	maxide, Prventyl inhaler	NONE	emphysema, allergy to Dramamine	NA~ ()~~~In patient	ID93102	1						1	Pneumonia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41122~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0059362	01/31/1994	ID	30.0	30		F	11/24/1993	tingling all over, difficulty breathing, dizziness; referred to MD; went to MD office & began to feel better & did not want to see MD;									Y	11/01/1993	11/17/1993	16		PUB	PUB		NA	PCN allergy	NA~ ()~~~In patient	ID93108	1						1	Dizziness; Dyspnoea; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~3F41029~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0059363	01/31/1994	ID	66.0	66		F	12/17/1993	Aches & pains, head congestion & runny nose; tightness in chest, dry cough; 10 days later asthma attack; vertigo x 4 days w/asthma attack;				Y					Y	10/28/1993				PUB	PUB	BP med	NA	taking med for blood pressure-asthma approx 20 yrs ago;	~ ()~~~In patient	ID93109	1						1	Asthma; Chest pain; Cough; Myalgia; Pain; Rhinitis; Vertigo	FLU3~CONNAUGHT LABORATORIES~3F41029~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0059364	01/31/1994	ID	37.0	37		F	11/04/1993	Fever of 103, chills, cough, lower lobe pneumonia on erythromycin;				Y					Y	10/28/1993	10/30/1993	2		PUB	PUB	Librax	NA	irritable bowel	NA~ ()~~~In patient	ID93110	1						1	Chills; Cough; Pneumonia; Pyrexia	FLUX~PFIZER\WYETH~4938226~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0059378	01/31/1994	TN	62.0	62		F	10/13/1993	aching legs lower torso; cold like sx; sore throat; feverish; t100 on 12OCt93;									Y	10/06/1993	10/10/1993	4	NONE	OTH	PUB	NA	NA	NA	~ ()~~~In patient	TN94005	1						1	Myalgia; Pharyngitis; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~4938181~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059379	01/31/1994	TN	25.0	25		F	11/04/1993	low grade fever (not ck'd), generalized aching, weak, dec appetite, sinus problems, did not miss work, sx lasted 4 days;									Y	10/25/1993	10/31/1993	6		PUB	PUB	(mood stabilizer) Wellbutrim & BCP's;	NONE	environmental allergies;	~ ()~~~In patient	TN94006	1						1	Anorexia; Asthenia; Myalgia; Pyrexia; Sinusitis	FLUX~PFIZER\WYETH~4938181~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059386	01/31/1994	TN	36.0	36		F	12/30/1993	sore lt arms-arm sore since 3NOV93 soreness from top of arm to wrist;										11/03/1993	11/03/1993	0		PUB	PUB				~ ()~~~In patient	TN94013	1						1	Myalgia	FLUX~PFIZER\WYETH~3E41123~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059387	01/31/1994	TN	45.0	45		F	01/10/1994	arm @ inject site red the size of a small orange itchy-leghargic feeling h/a, feels achy, chills & fevers;										01/07/1994	01/07/1994	0		PUB	PUB				~ ()~~~In patient	TN94014	1						1	Chills; Headache; Injection site hypersensitivity; Injection site mass; Myalgia; Pruritus; Pyrexia; Somnolence	FLU3~CONNAUGHT LABORATORIES~3E41123~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0059388	01/31/1994	TN	13.0	13		M	01/20/1994	dx w/pneumonia;										01/05/1994	01/19/1994	14		UNK	UNK				~ ()~~~In patient	TN94015	1						1	Pneumonia	FLUX~PFIZER\WYETH~4938084~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0057740	02/02/1994	CA	67.0			M	11/03/1993	Pt recvd vax & devel pain & redness @ site of inject then dyspnea; 3 days later was hospitalized w/dx of pulmonary insufficiency & a WBC count of 1700;					Y				Y	10/25/1993	10/28/1993	3	WBC 1700; WBC 14,00;	OTH	OTH	Isoniazid	COPD & alcohol abuse;	the pt is a smoker, a heavy drinker & has emphysema;	~ ()~~~In patient	893309008J	1						2	Amblyopia; Bundle branch block; Dyspnoea; Infection; Injection site hypersensitivity; Leukocytosis; Leukopenia; Pneumonia	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0059430	02/02/1994	PA	34.0	34		M	01/30/1994	Pt reported to have developed GBS;									U	10/25/1993	12/02/1993	38	Not available	OTH	PVT	Not known	None known	Not known	~ ()~~~In patient		1						1	Guillain-Barre syndrome; Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~3F41034~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~3F41034~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0061517	02/02/1994	PA	41.0	41		F	10/15/1993	Pt recvd vax & exp accentuation of Lyme's sx; w/in 2 wks of vax pt c/o fatigue, fever, joint aches & head & neck pain; sx lasted for more than 2 wks;									Y	11/05/1992	11/19/1992	14		PUB	OTH	unk	NONE	pre-existing Lyme disease;	~ ()~~~In patient	893300003C	1						1	Arthralgia; Asthenia; Condition aggravated; Headache; Neck pain; Pyrexia	FLUX~PFIZER\WYETH~4928130~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0061518	02/02/1994	TX				F	10/19/1993	pt recvd vax & devel a fever of 102 which lasted for 24 hrs;									Y					OTH	OTH	unk	unk		~ ()~~~In patient	893300020C	1						1	Pyrexia	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0061519	02/02/1994	WV	56.0	56		M	10/29/1993	pt recvd vax & exp cont soreness for 2 wks; p/soreness abated the pt had persistent burning sensation accompanied by intermittent pain; pt limits ROM; dx paresthesia;									N	10/20/1992	10/21/1992	1	16DEC93 EMG nl;	PUB	PUB	Synthroid	unk		~ ()~~~In patient	893314004J	1						1	Hypokinesia; Myalgia; Pain; Paraesthesia	FLUX~PFIZER\WYETH~4928203~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0061520	02/02/1994					M	10/04/1993	pt recvd vax & devel fever to 99-102 which lasted 1 wk; work-up was unrevealing; Reporter refused to provide pt or MD info;									Y					OTH	OTH	unk	unk		~ ()~~~In patient	893279011C	1						1	Pyrexia	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0061521	02/02/1994	KS	66.0			F	10/29/1993	pt recvd vax & w/in 30 mins pt exp vomiting for 3 hrs;									Y					PVT	PVT	unk	unk		~ ()~~~In patient	893314013J	1						1	Vomiting	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059504	02/03/1994	FL	63.0	63		F	01/18/1994	pt had flu shot & had asthmatic attack requiring 02 & provental;				Y					Y	12/13/1992			NA	PUB	PUB	Lopressor, Synfyroid, Travicel, ASA;	NONE	NONE	~ ()~~~In patient	FL94004	1						1	Asthma	FLU3~PARKE-DAVIS~00573P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0057797	02/07/1994	WA	54.0	54		F	11/23/1993	severe upper back pain, worsened w/radiating to rt breast; p/5 days weakness to all extremities; MD suspects GBS;			Y	Y	Y	49	Y			10/26/1993	11/03/1993	8	CFS test-no results;	PUB	PUB	NKA	NA	no allergies	~ ()~~~In patient		1						2	Back pain; Breast pain; Guillain-Barre syndrome; Myasthenic syndrome	FLUX~PFIZER\WYETH~4938226~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~PFIZER\WYETH~356964~UNK~~RA~PNEUMO (PNU-IMUNE)~2	USA	Life Threatening,Hospitalisation	Influenza
0059702	02/07/1994	CA	25.0			F	11/12/1993	On the 3rd day following vax pt felt very ill; went to hosp; LP pos for GBS; pt hospitalized; discharged & transferred to rehab unit;					Y			Y	N	10/08/1993	10/10/1993	2	NA	UNK	UNK	NA	healthy; pt has no hx of neuro porblems		NA~ ()~~0.00~Patient	9400123	1						1	CSF test abnormal; Guillain-Barre syndrome; Malaise	FLU3~PFIZER\WYETH~E2243GC~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation,Disabling	Influenza
0059707	02/07/1994	MA	62.0	62		M	01/31/1994	pt felt a little off; slow energy level, short tempered; 7JAN feeling sick, tired, achy, lightheaded, weak, stomach upset, nausea, vomiting, diarrhea, inc flatulence; 10JAN getting better still fatigued; 17JAN better but still faitgued;									Y	12/20/1993				UNK	PUB				~ ()~~~In patient	MA9401	1						1	Agitation; Asthenia; Diarrhoea; Dizziness; Dyspepsia; Flatulence; Myalgia; Vomiting	FLUX~PFIZER\WYETH~49380883~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059708	02/07/1994	MO	70.0	70		F	01/28/1994	Severe headache, bowel movement change, dizzy, vomiting; pt denies any local reaction;				Y					N	10/21/1993	10/30/1993	9	MRI neg for tumor/inner ear infect;	PUB	PUB		NONE	NONE	NONE~ ()~~~In patient	MO94006	1						1	Dizziness; Gastrointestinal disorder; Headache; Vomiting	FLU3~CONNAUGHT LABORATORIES~3F41027~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0059763	02/08/1994	NM	33.0			F	02/02/1994	w/in 5 mins of vax red, warm, pruritic inject site; 5 cm diameter; no systemic problem; rx'd DPH;									Y	10/22/1993	10/22/1993	0	NONE	PVT	PUB	BC pills	NONE	allerg: Bactrim pollens	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059764	02/08/1994	NM	30.0			F	02/01/1994	redness, induration, itch, heat, pain @ inject site w/persistent 3x6 cm redness next AM; redness, itch lasted 3 1/2 days total; also mild malaise 6 hrs p/vax;									Y	10/14/1993	10/14/1993	0	NA	PVT	PUB	Motrin	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Malaise; Pruritus; Vasodilatation; Injection site hypersensitivity; Injection site mass; Injection site pain; Malaise; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~4938125~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938125~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058007	02/09/1994	NY	53.0	53		M	11/15/1993	2 evenings p/flu shot pt exp severe abdo cramping, some diarrhea @ about 8PM on both 17OCT & 18OCT; began to have very sensitive needle like pains from waist to knees;				Y					Y	10/15/1993	10/17/1993	2	NONE	PUB	OTH	Hydrodiuril	NONE	some BP elevation	NA~ ()~~~In patient		1						2	Abdominal pain; Diarrhoea; Pain	FLUX~PFIZER\WYETH~4938152~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0058061	02/09/1994	WV	68.0	68		M	01/13/1994	Pt recvd vax 7OCT93 & 5 days later while on a trip out of the state, devel loss of appetite & malaise; seen by MD treated for poss pneumonia; pt transferred to another hosp for treatment of dilated cardiomyopathy;	Y	11/08/1993			Y	16	Y		N	10/07/1993	10/12/1993	5		PVT	PVT	Feldene, Zyloprim	unk	pt had hx of hypertension & myocardial infarction; allerg to Darvocet;	~ ()~~~In patient	894025001J	1						2	Cardiomyopathy; Encephalopathy; Hyperglycaemia; Hypoxia; Leukocytosis; Pneumonia; Renal failure acute; Right ventricular failure	FLUX~PFIZER\WYETH~~3~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Results in Death	Influenza
0058062	02/09/1994	MD	80.0	80		M	01/13/1994	pt recvd vax 20OCT93 & 1 day later devel a cough; treated by MD who prescribed a cough med; sx worsened & was adm to hosp on 28OCT93 in congestive heart failure; during hospitalization had a six beat run of ventricular tachycardia;					Y	12	Y		Y	10/20/1993	10/21/1993	1	ejection fraction-17%; Echocardiogram-dilated cardiomyopathy;	PVT	PVT	NONE	NONE	pt has hx of carcinoma of the colon treated by hemicolectomy in OCT90; suffered a MI postoperatively; allergic to Demerol; anemia;	~ ()~~~In patient	894025002J	1						2	Blood creatinine increased; Cardiomyopathy; Dyspnoea; Infection; Myocarditis; Right ventricular failure; Urinary retention; Ventricular tachycardia	FLUX~PFIZER\WYETH~4938262~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0058063	02/09/1994	MD	52.0	51		M	01/13/1994	Pt recvd vax 14OCT93 & was adm to hosp w/cardiogenic shock & a rt bundle branch block, which progressed to acute resp failure, renal failure; adm dx idiopathic dilated cardiomyopathy; treated in the ICU;					Y		Y		N	10/14/1993	11/09/1993	26	Echocardiogram-dilated cardiomyopathy;	PUB	PUB	NONE	unk	pt is allergic to PCN, has a long hx of alcohol abuse & has alcoholic cardiomyopathy;	~ ()~~~In patient	894025003J	1						2	Apnoea; Bundle branch block; Cardiomyopathy; Renal failure; Shock	FLUX~PFIZER\WYETH~4938143~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0059775	02/09/1994	ME	70.0	70		F	01/04/1994	pt recvd vax SEP93 & devel nausea & vomiting; the next day devel severe pain in both shoulder & throughout body; subsequently lost the use of arms; adm to hosp where was given a dx of GBS;			Y		Y	90	Y	Y	N	08/31/1993	09/05/1993	5		PVT	PVT	Synthroid; Glynase 1.5 mg; Relafen 500 mg;	NONE	pt is diabetic; allergic to penicillin & sulfa; has hypertension, hypercalcemia, obesity, hypercholesterolemia, hematuria, proteinuria; s/p rt arm tumor resection in 1980 & throidectomy for malignant nodule in 1970's;	~ ()~~~In patient	894024001J	1						1	Asthenia; CSF test abnormal; Guillain-Barre syndrome; Muscle atrophy; Neuropathy; Pain; Quadriplegia; Thinking abnormal	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0059790	02/09/1994	NJ	76.0	76		M	01/28/1994	diffuse hives predominently over torso; DPH given;									Y	10/14/1993				PUB	OTH	?	NONE	allergies PCN- dxs=D.J.D.; P.A.D: neurogenic bladner; dxs varicose veins;	NONE~ ()~~~In patient		1						1	Urticaria; Hypersensitivity; Urticaria	FLU3~PARKE-DAVIS~~UNK~IM L~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0059791	02/09/1994	MI	50.0	50		F	01/25/1994	had moderate to severe pain in legs that lasted all day;									Y	01/11/1994	01/12/1994	1	NONE	PVT	PVT	Lodine	arthritis of joint	NONE	pt exp ache in legs @ 50 y/o w/flu vax #1;~ ()~~~In patient		1						1	Pain	FLU3~CONNAUGHT LABORATORIES~3F41140~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0058135	02/14/1994	MA	73.0			M	02/03/1994	Death; Idiopathic thrombocytopenic purpura; respiratory insufficiency; also exp thrombocytopenia, cutaneous hemorrhages, hemorrhages, devel SOB, cough of bloody phlegm; pt hospitalized; tachycardia, pneumonia, acute resp distress synd;	Y			Y	Y				N				BP 130/70, P92, R24, Temp nl; Hemoglobin 11.3, Hematocrit 33.7, RBC 4.06 million, platelet count 3,000 and repeat 2,000. The WBC was 9,500 with polys of 74%, lymphs 18, MONOS 7%, EOS-less than 1%, reticulocyte 2.4, sed rate 35, PCO2 25, PH 7.54, Blood sugar 133, BUN 28, alkaline phosphatase 95, LDH376	PVT	PVT	Nitordur patch; Tenormmin; ASA;	NONE	myocardia infarction & CVA 1991; carotid artery stenosis;		28621	1						3	Blood lactate dehydrogenase increased; Haemoptysis; Pericardial effusion; Pneumonia; Respiratory disorder; Tachycardia; Thrombocytopenia; Thrombocytopenic purpura	FLU3~PARKE-DAVIS~~4~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~3	USA	Results in Death	Influenza
0059764	02/14/1994	NM	30.0			F	02/08/1994	pt exp redness, induration, itch, heat, pain @ inject site w/persistent 2x6 cm redness next AM redness, itch lasted 3 1/2 d total; also mild malaise 6 hrs p/inject;										10/13/1993	10/14/1993	1	NA	PUB	PUB	Motrin			~ ()~~~In patient		1						2	Injection site hypersensitivity; Injection site mass; Injection site pain; Malaise; Pruritus; Vasodilatation; Injection site hypersensitivity; Injection site mass; Injection site pain; Malaise; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~4938125~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938125~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0059819	02/14/1994	GA	52.0	52		F	10/29/1993	pain in rt leg & lower back; numbness started 18OCT93 in foot & cont; reported to MD;				Y					U	10/13/1993	10/16/1993	3	CT Scan & MRI neg;	PUB	PUB	Lanoxin; Non pace	NONE	heart & had a stroke 7 yrs ago;	NONE~ ()~~~In patient	GA93214	1						1	Back pain; Pain; Paraesthesia	FLU3~PARKE-DAVIS~00873P~2~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0059820	02/14/1994	GA	55.0	55		F	11/03/1993	onset 9OCT93 pain lt arm; swelling lt arm lt elbow up to lt shoulder; states arm doubled in size;  arm was warm to touch; p/3-4 days swelling gone; states left w/feeling of having pulled ligament & limited ROM;				Y					N	10/08/1993	10/09/1993	1		PUB	PUB	Provera & premarin			~ ()~~~In patient	GA93215	1						1	Hypokinesia; Injection site oedema; Pain; Tendon disorder; Vasodilatation	FLU3~PARKE-DAVIS~00193P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~0439W~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0059821	02/14/1994	GA	20.0	20		F	11/05/1993	pt recvd vax had soreness, tingling & no feeling in rt arm on 3NOV93; red swollen area approx 5cm @ site;									Y	11/02/1993	11/04/1993	2	NONE	PUB	PUB	PPD by Parke Davis lot# 01963P	NONE	NONE	~ ()~~~In patient	GA93216	1						1	Injection site hypersensitivity; Injection site oedema; Myalgia; Paraesthesia	FLU3~PARKE-DAVIS~01263P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0059822	02/14/1994	GA	71.0	71		M	11/04/1993	flu shot started having sore throat, coughing, sneezing, eyes watery, chest soreness; t100;									Y	10/29/1993	10/29/1993	0		PUB	PUB		NONE		~ ()~~~In patient	GA93217	1						1	Chest pain; Cough; Lacrimal disorder; Pharyngitis; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~4938151~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059823	02/14/1994	GA	64.0	64		M	11/08/1993	pt recvd vax 29OCT93 & exp sore throat, nose running, eyes watery, coughing;									U	10/29/1993	10/29/1993	0	NONE	PUB	PUB	NONE			NONE~ ()~~~In patient	GA93218	1						1	Cough; Lacrimal disorder; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4938138~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059824	02/14/1994	GA	64.0	64		F	11/08/1993	pt recvd vax 29OCT93 & exp sore throat, nose running, eyes watery, coughing;									U	10/29/1993	10/29/1993	0	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	GA93219	1						1	Cough; Lacrimal disorder; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4938138~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059827	02/14/1994	GA	73.0	73		F	11/18/1993	aprox 1 hr p/vax pt had pain in opposite arm (rt) & drawing of fingers, loss of use in arm (partial); called MD: pt hospitalized w/dx of prob stroke;					Y				U	11/16/1993	11/16/1993	0		PUB	UNK	NONE	NONE	arthritis	~ ()~~~In patient	GA93222	1						1	Cerebrovascular accident; Hypokinesia; Pain	FLU3~PARKE-DAVIS~00193P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0059828	02/14/1994	GA	58.0	58		M	11/19/1993	Pt had hx of diabetes, elevated BP & obesity; devel GBS approx 2 wks p/vax; devel pneumonia & was put on ventilater;	Y	11/09/1993			Y				N	10/07/1993	10/21/1993	14		PUB	PUB		NONE	diabetes, hypertension, obesity	~ ()~~~In patient	GA93223	1						1	Guillain-Barre syndrome; Pneumonia; Respiratory disorder	FLU3~PFIZER\WYETH~631923~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Results in Death	Influenza
0059830	02/14/1994	GA	65.0	65		F	11/29/1993	pt recvd vax 2NOV93 & 4NOV93 started w/malaise; c/o severe pain in rt hip on 5th remained in bed 5th & 6th; c/o nausea, vomiting & diarrhea on 6th admitted to hosp 7NOV w/severe dehydration w/elevated tem; dx pneumonia;					Y	12			Y	11/02/1993	11/04/1993	2		PUB	PUB		NONE		~ ()~~~In patient	GA93225	1						1	Arthralgia; Dehydration; Diarrhoea; Malaise; Nausea; Pneumonia; Pyrexia; Vomiting	FLUX~PFIZER\WYETH~4938085~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0059842	02/14/1994	GA	73.0	73		M	10/18/1993	itchy rash over body, concentrated on chest & around waist; lasted 2 days;									Y	10/15/1993	10/16/1993	1	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	GA93237	1						1	Pruritus; Rash	FLU3~PARKE-DAVIS~00873P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0059843	02/14/1994	GA	63.0	63		F	10/18/1993	eyes edematous & bloodshot; chills & fever 100; fever & eye problem cont 18OCT93; sore throat 17OCT93; back of neck aches; feels miserable;									Y	10/14/1993	10/16/1993	2	NONE	PUB	PUB	Roscell; Prilosex; Acupril/HCTZ; Mezcar;	NONE	hi PB hiatal hernia-hay fever-acne;	NONE~ ()~~~In patient	GA93238	1						1	Chills; Conjunctivitis; Face oedema; Malaise; Neck pain; Pharyngitis; Pyrexia	FLU3~PARKE-DAVIS~00873P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~CONNAUGHT LABORATORIES~3D51079~3~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0059845	02/14/1994	GA	84.0	84		F	10/23/1993	red area on lt arm not @ site of inject, but on inner aspect of upper arm & around the navel; diarrhea this AM;									U	10/19/1993	10/20/1993	1	NONE	PUB	PUB	NONE	NONE	NONE	NA~ ()~~~In patient	GA93240	1						1	Diarrhoea; Injection site hypersensitivity; Vasodilatation	FLU3~PARKE-DAVIS~00873P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~324906~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0059846	02/14/1994	GA	77.0	77		M	10/27/1993	1AM screamed-convuls, eyes rolled back, unconscious, no involuntary excrement; taken to hosp by EMs; combative on way to hosp;					Y	4			Y	10/12/1993	10/15/1993	3	all neg;	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	GA93241	1						1	Agitation; Convulsion; Crying; Gaze palsy; Hostility; Stupor	FLU3~PARKE-DAVIS~00873P~5~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0059847	02/14/1994	GA	64.0	64		F	10/27/1993	called stating both arms are red & swollen; 1st time for pneummonia vax but has had flu vax many times; both arms itching;									Y	10/25/1993	10/26/1993	1		PUB	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	GA93242	1						1	Oedema peripheral; Pruritus; Vasodilatation	FLU3~PARKE-DAVIS~00873P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~326921~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0059848	02/14/1994	GA	46.0	46		F	10/28/1993	onset of pain in LUE 2 hrs p/vax; rash evening of 27OCT; erythematous, macular, swelling, fever & pain in LUE;									Y	10/26/1993	10/26/1993	0		PUB	PUB	NONE	NONE	hx of multiple allergies to meds, bee stings, olives	NONE~ ()~~~In patient	GA93243	1						1	Injection site oedema; Injection site pain; Pyrexia; Rash; Rash maculo-papular	FLU3~PARKE-DAVIS~00873P~2~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~326921~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0059861	02/14/1994	TX	36.0	35		F	01/12/1994	c/o rt arm numbness & painful c/o pain in rt upper & lower arm & paresthesias in rt middle finger; pain in shoulder joint when uses it also seem to have sl pain on palp of rt deltoid muscle grip strength in rt arm questionable sl diminished										11/29/1993	12/13/1993	14		PUB	UNK	NONE	NONE	NONE	~ ()~~~In patient	TX9403	1						1	Arthralgia; Myalgia; Myasthenic syndrome; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~3F41009~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0059885	02/14/1994	CA	68.0	68		M	12/21/1993	Guillian Barre synd undergoing plasmapheresis;			Y	Y	Y	45	Y		N	10/29/1993	11/07/1993	9	CSF	OTH	PVT		NONE		~ ()~~~In patient		1						1	Guillain-Barre syndrome; Guillain-Barre syndrome	FLUX~PFIZER\WYETH~4938148~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation	Influenza
0059886	02/14/1994	CA	59.0	59		M	12/21/1993	Guillian Barre Synd;				Y	Y	10			Y	11/23/1993	12/03/1993	10	CSF	OTH	PVT	Kemedrin	parkinson disease	parkinson's disease	~ ()~~~In patient		1						1	Guillain-Barre syndrome; Paraesthesia; Paraplegia	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0059888	02/14/1994	TX	36.0	36		F	02/08/1994	w/in 24 hrs sneezing, nasal congestion, felt bad next 48 hrs; 18OCT93 generalized body rash, hoarseness & throat constriction;				Y					Y	10/14/1993	10/15/1993	1		UNK	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Dysphonia; Laryngospasm; Malaise; Rash; Rhinitis	FLUX~PFIZER\WYETH~4938227~5~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0059903	02/15/1994	KS	40.0	40		F	11/04/1993	pt recvd vax & immed arm felt hot all over; denied taking APAP or an antiinflammatory; inc pain in arm for 3 days p/inject; back pain 22OCT;					Y	23			N	10/22/1993	10/22/1993	0	NONE	OTH	OTH	NONE	NONE	NONE	NA~ ()~~~In patient	KS93072	1						1	Asthenia; Back pain; Chest pain; Insomnia; Metrorrhagia; Palpitations; Paraesthesia; Tachycardia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0059912	02/15/1994	IL	27.0	27		M	02/11/1994	good health;									Y	01/14/1992	05/07/1992	114	hepatitis C (HCV);	PUB	OTH	nONE	NONE	hearing loss from birth	~ ()~~~In patient		1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059917	02/16/1994	WA	40.0			F	02/09/1994	brachial neuralgia rt arm w/neuralgic amyotrophy, weakness of arm w/limited motion of thumb & index finger; MRI nl undergoing physical therapy as of 8FEB94;				Y					N		11/16/1993			PVT	PVT	LOPID	NONE	hypercholesterolemia	NONE~ ()~~~In patient	CO5272	1						1	Hypokinesia; Muscle atrophy; Myasthenic syndrome; Neuralgia; Neuritis	FLU3~CONNAUGHT LABORATORIES~3F41140~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0060763	02/16/1994	MD	44.0	44		F	10/27/1993	pt recvd vax & felt well during the day but layed down in the afternoon & found had wet the bed; that evening pt was found by mom in bed sweaty, incoherent, & unable to be aroused; pt states reflexes still feel hyper;				Y					Y	10/06/1993	10/06/1993	0	EEG-sz activity in lt & rt temporal lobes	PVT	OTH	NONE	NONE	pt has had influenza immun in 8 prev yrs w/o any apparent adverse effects;  allergic to PCN;	~ ()~~~In patient	893309004J	1						1	Convulsion; Electroencephalogram abnormal; Hyperhidrosis; Nervousness; Stupor; Thinking abnormal; Urinary incontinence; Convulsion; Electroencephalogram abnormal; Malaise; Stupor; Urinary incontinence	FLUX~PFIZER\WYETH~4938159~7+~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938159~3~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0060767	02/16/1994	NJ				M	10/22/1993	pt recvd vax & 24 hrs later pt devel hives on back which resolved w/in the next 24 hrs w/o treatment;									Y	10/21/1993	10/22/1993	1		OTH	OTH	unk	NONE		~ ()~~~In patient	893313006J	1						1	Urticaria	FLUX~PFIZER\WYETH~4938182~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060804	02/16/1994	AL	42.0	42		F	12/02/1993	pt recvd vax on 23NOV93 & the next day devel an upper resp infect & a h/a which lasted for 2 days; approx 4 days p/vax exp onset of vomiting & diarrhea; pt was treated by MD;				Y					U	11/22/1993	11/23/1993	1	CBC showed elevated WBC; chest x-ray within nl limits;	PUB	PVT	NONE	NONE		~ ()~~~In patient	893343009J	1						1	Dehydration; Diarrhoea; Headache; Leukocytosis; Malaise; Pharyngitis; Vomiting	FLUX~PFIZER\WYETH~4938183~3~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060807	02/16/1994	IA	49.0	49		F	11/29/1993	pt recvd vax 27OCT93 & c/o bursitis in the arm of inject; following treatment w/ a steroid inject sx abated;									Y	10/27/1993	11/06/1993	10		PUB	OTH	unk		Prior condition of bursitis in rt arm;	~ ()~~~In patient	893343012J	1						1	Condition aggravated	FLUX~PFIZER\WYETH~4938254~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060811	02/16/1994	FL	15.0			F	12/02/1993	Pt recvd vax 21NOV93 & devel hyperglycemia, fever 100 & convuls; upon request for addtl into, reporter stated that pt could not be identified;									Y	11/21/1993			BLood glucose 400mg%:	OTH	OTH	Insulin	unk	pt is a diabetic	~ ()~~~In patient	893343016J	1						1	Convulsion; Hyperglycaemia; Pyrexia	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059934	02/17/1994	NJ	72.0	71		F	02/11/1994	severe pain @ onset, then involved total body; rapid heart beat; breathing difficult @ times; inability to stand straight then to walk w/o assistance; abn quantities of sleep; apathy, weakness; discomfort;				Y					Y	10/15/1993	10/25/1993	10	Chem screen for contrast; x-rays of spine;	PVT	OTH	Theo-dur; Sectral; Ventolin; Azmacort; Vitamins E-C lecithin; L-Lycine;	NONE	COPD	pt exp pain, breathing difficult @ times; inability to stand straight;~ ()~~~In patient		1						1	Apathy; Asthenia; Dyspnoea; Gait disturbance; Hypochromic anaemia; Somnolence; Tachycardia; Thrombocythaemia	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0059942	02/18/1994	OH	66.0	66		M	01/25/1994	Pt recvd flu vax 5NOV93 & presented to MD w/neck pain, & prescribed unspecified meds; devel tingling in hands & feet, terrible pain in the legs; c/o of pain, tingling, paralysis in legs & hands & numbness; dx GBS due to a viral infect;				Y	Y	11			U	11/05/1993	12/13/1993	38		PVT	OTH		unk	hx of MI, cardiac arrhythmia & elevated cholesterol;	~ ()~~~In patient	894031011J	1						1	Facial palsy; Guillain-Barre syndrome; Myelitis; Neck pain; Pain; Paraesthesia; Paralysis; Vascular anomaly	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0059945	02/18/1994	TN	65.0	65		M	11/01/1993	Pt recvd vax & w/in 5 mins pt exp exacerbation of Transverse Myelitis; new numbness & inc weakness were noted; pt was treated w/ Solu Medrol;							Y		N	10/19/1993	10/25/1993	6		PVT	OTH	NONE	transverse myelitis w/paraplegia	pt has recvd flu vax in past w/o incident; intermittent diplopia;	~ ()~~~In patient	893314010J	1						1	Asthenia; Condition aggravated; Paraesthesia	FLUX~PFIZER\WYETH~4938123~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0059949	02/18/1994	FL	40.0	40		F	12/24/1993	incapacitating h/a-sharp pain on rt side of head, followed by spreading pain to back of head; prescribed 2 courses of treatment of methylprednisolone, w/Demerol for pain;				Y					U	12/01/1993	12/03/1993	2	MRI-nl; spinal tap-nl;	PVT	PVT			allergy (airborne)/asthma/mup/HRT murmur;	~ ()~~~In patient		1						1	Headache	FLU3~CONNAUGHT LABORATORIES~3F41132~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0059961	02/22/1994	AR	2.0	2	.8	M	12/22/1993	23NOV93 pt started vomiting, running a fever, mom didn't have a therometer;				Y					Y	11/15/1993	11/23/1993	8	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	AR941	1						1	Pyrexia; Vomiting	DTP~CONNAUGHT LABORATORIES~3A51135~4~IM~RA~DTP (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~3F41032~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~PFIZER\WYETH~M005JP~4~IM~LA~HIB (HIBTITER)~1	USA	Emergency room visit	Influenza
0059962	02/22/1994	AR	74.0	74		F	12/27/1993	hosp 9DEC93 p/2 days of confusion, loss of appetite, MD thought was CVA-neuro exam abn, t103.4; 13DEC dx viral or bacterial meningitis; lymphocytes inc; culture neg, but on ATB; Anorexia;			Y	Y	Y	14	Y		Y	10/20/1993	12/08/1993	49	culture neg, but pt on UTI ATB x 1 wk prior to hospitalization; residual aparaxia;	PUB	PUB	NONE	NONE	hay fever	NONE~ ()~~~In patient	AR942	1						1	Anorexia; Aphasia; Confusional state; Infection; Lymphocytosis; Meningitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41032~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0059968	02/22/1994	AR	5.0	5		M	11/04/1993	pt returned  following day quarter-sized raised bumps on back; seen by MD stated that pt had an adverse reaction to flu vax;				Y					Y	10/26/1993	10/27/1993	1	NONE	PUB	PUB	NONE	NA	NA	~ ()~~~In patient	AR948	1						1	Skin nodule; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~3F41032~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~3F41032~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0059978	02/22/1994	NC	63.0	62		F	02/01/1994	21NOV 3AM woke up w/severe rt leg pain (above ankle), numbness rt hip to rt knee; put on bedrest x 17 days; hospitalized 7DEC93 x 3 days; tenderness in groin, pubic area rt hip; strength is gradually coming back;				Y	Y	3			Y	10/29/1993	11/21/1993	23	Myelogram, CT Scan 2DEC93; Blood sugar 110; dx poly infectious diabetic neuropathy;	PUB	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	NC94015	1						1	Arthralgia; Asthenia; Laboratory test abnormal; Neuropathy; Pain; Paraesthesia; Pelvic pain	FLU3~PARKE-DAVIS~00963P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0059999	02/23/1994	IL	38.0	38		F	12/07/1993	started itching immediately p/vax & devel rash w/blisters starting on face then to neck then scalp then axilla; spoke w/clin who recommended DPH;									Y	11/15/1993	11/15/1993	0	NONE	PUB	UNK		NONE	NKA	~ ()~~~In patient	IL93136	1						1	Dermatitis bullous; Pruritus	FLUX~PFIZER\WYETH~4938086~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060001	02/23/1994	NH	54.0	54		M	02/08/1994	4FEB94 dry heaves-very bad-nausea; evening time only; 6FEB94 dry heaves-less severe;									Y	02/04/1994	02/04/1994	0	NA	PUB	PUB	Proventil, Prednisone, Arobid;	NA	COPD, asthma, HTN, hypercholeerolemia	~ ()~~~In patient	NH94004	1						1	Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~3F41008~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~LEDERLE LABORATORIES~356901~UNK~IM~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0060003	02/23/1994	TX	22.0	22		M	02/16/1994	Guillian Barre Synd;					Y		Y		N	12/07/1993	12/20/1993	13		PUB	UNK		NONE	NONE	~ ()~~~In patient	TX9444	1						1	Guillain-Barre syndrome; Neuropathy; Guillain-Barre syndrome; Back pain; Myasthenic syndrome; Neck pain; Neuropathy	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~3F41124~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~3F41124~1~~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Hospitalisation	Influenza
0057083	02/24/1994	PA	41.0	41		F	02/03/1994	Pt recvd vax 23SEP93 & 24 hrs later devel numbness & painful paresthesias of the trunk which then extended to the upper extremities down to calves; adm to hosp, underwent MRI of brain & spinal cord, LP  & unspecified blood work;				Y	Y	3			U	09/23/1993	09/24/1993	1	MRI Brain-nl; MRI spine-demyelinating lesion @ c-2; LP-results unk;	PVT	OTH	Motrin	unk	none specified;	~ ()~~~In patient	894045001J	1						2	Myelitis; Pain; Paraesthesia	FLUX~PFIZER\WYETH~4938143~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0060018	02/24/1994	SC	78.0	78		M	10/13/1993	pt recvd flu vax & devel redness, & swelling in the arm of inject & lt shoulder pain; pt exp an episode of syncope which resulted in hospitalization for 6 days;									Y	10/12/1993	10/12/1993	0		PVT	OTH	Atarax; Darvocet;	unk	pt has a history of hypoprothrombinemia, anemia, & iron loss; NKA; pt was hospitalized in MAY93 for syncopal;	~ ()~~~In patient	893299005C	1						1	Injection site reaction; Oedema peripheral; Pain; Syncope; Vasodilatation	FLUX~PFIZER\WYETH~4938088~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0060022	02/24/1994	CA	29.0	29		F	11/15/1993	pt states 1 wk p/shot, awakened w/ache & pain in muscles (esp cal of legs) & swollen joints (exp lower half of body); WBC nl but sed rate sl elevated;				Y					N	10/09/1993	10/15/1993	6	sed rate 27;	OTH	PUB	Testosterone		biological female undergoing emasculination by harmone therapy;	~ ()~~~In patient	CA94012	1						1	Myalgia; Osteoarthritis; Red blood cell sedimentation rate increased	FLUX~PFIZER\WYETH~4938142~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060023	02/24/1994	CA	70.0	70		F	01/04/1994	discolored area 4x5, swollen, tender to touch appeared bruised, became darker & almost black; still present 25OCT93; By late DEC93, area faintly discolored; other bruises present from B12 inject in different areas;				Y					Y	10/12/1993	10/13/1993	1		PUB	PUB	ASA; B12 inject; Zantac, Predinsone;	NONE	pernicious anemia	~ ()~~~In patient	CA94016	1						1	Ecchymosis; Oedema; Pain; Skin discolouration	FLUX~PFIZER\WYETH~4938148~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~330948~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0060024	02/24/1994	CA	69.0	69		M	10/18/1993	1 hr p/injecr resident exp a runny nose & pain over mid chest on lt side w/o radiation of lt arm lasting 10 mins; denied SOB;									Y	10/18/1993	10/18/1993	0	NONE	OTH	PUB	hypertension	NONE	Hypertension	NONE~ ()~~~In patient	CA94017	1						1	Chest pain; Rhinitis	FLUX~PFIZER\WYETH~4938142~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060027	02/24/1994	CA	67.0	67		F	01/06/1994	22OCT tired, muscle aches, h/a, nausea, runny nose, felt warm, had chills, cont few days; mild sore throat; 27OCT seen by MD; throat was red-no lab work done;				Y					Y	10/15/1993	10/22/1993	7	NONE	PUB	PUB	THyroxin, Maxzide, Tenomin, Potassium;	NONE	Ileostomy; HTN; THyroid surgery 65;	~ ()~~~In patient	CA94020	1						1	Asthenia; Chills; Headache; Myalgia; Nausea; Pharyngitis; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~4938148~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060032	02/24/1994	MI	54.0	54		F	11/02/1993	pt recvd flu vax @ 1030AM waited for 15 mins w/no adverse react; 4PM the same afternoon pt c/o throat tightening & muscle tenderness on rt side of neck under chin; difficult swallowing & throat sore but not red; muscle achiness, tiredness;				Y					Y	10/26/1993	10/26/1993	0	blood drawn 2PM;	PUB	UNK	Ibuprofen;	only a cold 2 wk ago	arthritis	NA~ ()~~~In patient	MI94006	1						1	Asthenia; Dysphagia; Laryngospasm; Myalgia; Neck pain; Pharyngitis	FLUX~PFIZER\WYETH~4938086~2~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060059	02/24/1994	CA	21.0	21		F	11/15/1993	stuffy nose, some sneezing on 20OCT; 21OCT inc congestion & sneezing, hoarse, felt warm, tired, headache, sl early AM cough; seen @ clinic;				Y					Y	10/20/1993	10/20/1993	0	NONE	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Cough; Dysphonia; Headache; Infection; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~3F41124~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0060066	02/25/1994	IL	54.0	54		F	01/31/1994	approx 2 wks p/vax pt was hospitalized for GBS; dx made by nerologist (pos EMG & LP); pt currently has paralysis of both legs & arms; pt is on resp;					Y	14			N	12/29/1993	01/09/1994	11	EMG-positive GUB; LP-pos GBS;	PVT	PVT	Dyazide, hormone therapy;	healthy	Hypertension, arthritis, allergies to sulfa, demerol, ampicillin, ASA; h/o scoliosis of spine recently evaluated, hysterectomy in 1974, cholecystectomy in 1991, breast biopsy for fibrocystic disease in 1993;	NA~ ()~~~In patient	940017901	1						1	CSF test abnormal; Guillain-Barre syndrome; Laboratory test abnormal; Paralysis; Respiratory disorder	FLU3~PFIZER\WYETH~359907~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation	Influenza
0060086	02/28/1994	MA	34.0	34		F	02/14/1994	pt recvd flu vax 22OCT93 & 29OCT93 noted onset of h/a which worsened; 30OCT93 to ER for eval; hospitalized 31OCT93-4NOV93; dx aseptic meningitis;					Y	5			Y	10/22/1993	10/28/1993	6	LP & culture;	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MA9405	1						1	Headache; Meningitis	FLUX~PFIZER\WYETH~4938083~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0060092	02/28/1994	TN	33.0	33		M	01/17/1994	pt recvd vax & 3 days following vax red papular urticaria severe itch began on chest area-quickly spreading to all southern region-then spreading to all Northern areas; oozing vesicles covering entire body including face & scalp; swelling;										10/21/1993	10/24/1993	3	CBC-diff; platelets; UA; lupus; ANA; Glucose all WN: glucose-nl; Tri-choles-226; EOS-4%; CXR & Quiac x 2 refused by pt;	UNK	UNK	Pred; Atarax;			~ ()~~~In patient		1						1	Alopecia; Dermatitis bullous; Dermatitis exfoliative; Oedema; Pruritus; Urticaria	FLUX~PFIZER\WYETH~4938183~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060094	02/28/1994	IL	22.0	22		M	11/30/1993	pt devel wheals w/itching, swollen lips & mild SOB p/vax;										11/30/1993	11/30/1993	0		UNK	UNK	PPD		milk intolerance	~ ()~~~In patient		1						1	Dyspnoea; Face oedema; Pruritus; Urticaria	ADEN~UNKNOWN MANUFACTURER~~UNK~~~ADENOVIRUS (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~UNK~~~MENINGOCOCCAL (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|OPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, ORAL (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0060098	02/28/1994	FL	39.0			M	01/06/1994	to ER c/o inc weakness both legs, unable to walk, difficulty w/coordination of arms & difficulties talking or swallowing; 2 days p/vax: URI, rx'd w/Trimox, Keflex, Antivert, & Humibid; dx: GBS w/C. Fisher variant; required therapy, d/c16OCT			Y	Y	Y			Y	Y	10/02/1993	10/07/1993	5	WBC 4.1, H/H 14.7/41.7; CSF-clear C&S neg, prot 83 mg/dl, glu 65 mg/dl; H.Influ, S.pneumo, N.mening neg; lead, arsenic, mercury levels neg, thallium neg; bone marrow aspiration-mild erythroid hyperplasia; IgA 120, IgG 1120, IgM 49.4, IgG ka	UNK	UNK		Cat scratch few weeks ago;	Allergic to iodine; s/p tonsillectomy/adenoidectomy; s/p surgery for varicocele;	~ ()~~~In patient		1						1	Coordination abnormal; Dysphagia; Guillain-Barre syndrome; Hypokinesia; Leukopenia; Marrow hyperplasia; Myasthenic syndrome; Speech disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0060099	02/28/1994	MI	23.0	23		M	10/29/1993	pt came in 28OCT for influenza vax  @ 355PM vas given; pt began arching back, made a loud sound, skipped out of chair to floor & begin convulsing for approx 2-3min;				Y					Y	10/28/1993	10/28/1993	0	NONE	PVT	PVT	NONE	NONE	allergy to Amoxicillin	~ ()~~~In patient		1						1	Convulsion; Opisthotonus	FLUX~PFIZER\WYETH~4938181~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060115	03/01/1994	AZ	75.0	75		F	02/19/1993	pt describes onset of pain in opposite arm from inject site 1 day following vax; this pain extended from palm to shoulder on inside of arm; sx progressed to involve lt arm & both knees & lower limbs assoc w/malaise & weakness;								Y		11/01/1993				PUB	PUB	Ativan	NONE		pt exp rxn @ 59 y/o w/swineflu dose 1;~ ()~~~In patient	AZ9408	1						1	Arthralgia; Asthenia; Malaise; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0060127	03/02/1994	KY	43.0			F	02/23/1994	progressive ataxia weakness numbness 6 wks p/flu shot;					Y	17			Y				MRI brain old CVA; CSF protein 45;	PVT	UNK			hypertension old CVA	~ ()~~~In patient		1						1	Asthenia; Coordination abnormal; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0060236	03/03/1994	MA	15.0			F	02/03/1994	Pt recvd vax & devel transverse myelitis w/lt foot drop; reporter feels this has caused permanent disability;								Y	N					OTH	OTH	unk	unk	pt has infect mononucleosis	~ ()~~~In patient	894045002J	1						1	Drug dependence; Myelitis; Peroneal nerve palsy	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0060237	03/03/1994	PA	80.0	80		M	02/08/1994	pt recvd vax 30SEP93 & 4NOV93 presented w/ a wk history of chest discomfort; PE had a new pericardial friction rub; EKG was unchanged; pt was treated w/ASA & improved; reporter states that viral pericarditis was not ruled out in this pt;				Y					Y	09/30/1993	10/27/1993	27	EKG-ventricular conduction delay (unchanged from usual); Serum creatinine-1.9;	OTH	OTH	unk	NONE	pt has a history of ischemic heart diaseas, status post myocardial infarction & coronary artery bypass graft in 1984; had recurrent congestive heart failure, gout, hypothyroidism, & chronic renal insufficiency w/serum creatinine 1.5-2.0;	~ ()~~~In patient	894046010J	1						1	Chest pain; Infection; Pericarditis	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060238	03/03/1994	PA	61.0	61		M	02/08/1994	pt recvd vax 24SEP93 & was adm to hosp on 15NOV93 w/a 2 day history of atypical chest pain; PE did not have a pericardial friction rub, but EKG showed sl elevation in the inferior & lateral leads; reporter states viral pericarditis not r/o				Y	Y	1			Y	09/24/1993	11/13/1993	50	EKG-diffuse ST elevation & PR depression;	PVT	OTH	unk	NONE		~ ()~~~In patient	894046011J	1						1	Blood lactate dehydrogenase increased; Chest pain; Electrocardiogram ST segment elevation; Electrocardiogram abnormal; Infection; Pericarditis	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0060239	03/03/1994	PA	75.0	75		F	02/08/1994	pt recvd vax 6OCT93 & adm to hosp 2NOV93 w/c/o pleuritic lt sided chest pain; pericardial friction rub was noted on physical exam; electrocardiogram showed new diffuse ST elevation & t wave inversion; mild EKG changes remained;				Y	Y	1			Y	10/06/1993	11/02/1993	27	echocardiogram-no pericardial effusion, mild lt artial enlargement; EKG-diffuse ST elevation & t wave inversion; Thyroid function tests-nl; Renal function Tests-nl;	PVT	OTH	unk	unk	pt has a hx of metastic renal cell carcinoma, w/metastasis to the lung, brain, & bones; last course of chemotherapy SEP93 had to be terminated due to lethargy & anorexia;	~ ()~~~In patient	894046009J	1						1	Cardiomegaly; Chest pain; Electrocardiogram ST segment elevation; Electrocardiogram T wave inversion; Electrocardiogram abnormal; Infection; Pericarditis; Pulmonary embolism	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0060240	03/03/1994	TX	61.0	61		F	02/25/1994	Pt recvd vax & exp tingling sensation in hands, arms & legs & weakness, making mobility difficult; pt was seen by 2 MD's during this time; resp problems;				Y	Y		Y			11/09/1993	11/30/1993	21		PVT	UNK		NONE	cedar allergy-heartbypass JUL93;	~ ()~~~In patient		1						1	Asthenia; Hypokinesia; Paraesthesia; Respiratory disorder	FLUX~PFIZER\WYETH~4938166~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0060250	03/04/1994	TN	35.0	35		F	11/10/1993	generalized aching, t102.8, rash behind knees & in armpits; sx lasted 48 hrs & then fully recovered;									Y	10/28/1993	10/28/1993	0	NONE	PUB	PUB	NONE	NONE	allergy to ragweed & kuir	~ ()~~~In patient	TN94021	1						1	Myalgia; Pyrexia; Rash	FLUX~PFIZER\WYETH~4938181~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060265	03/04/1994	WI	72.0	72		M	02/28/1994	paresthesias-legs got hard & muscles stiff 5 days p/flu shot cont to have trouble walking;									N	10/12/1993	10/17/1993	5	NONE	PUB	PUB	NONE		NONE	NONE~ ()~~~In patient		1						1	Gait disturbance; Hypertonia; Paraesthesia	FLU3~PARKE-DAVIS~01173P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0060267	03/04/1994	MA	37.0	37		M	12/10/1993	pt devel flu like sx including malaise, myalgia; sx had resolved by 9NOV93;									Y	11/04/1993	11/07/1993	3	NONE	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Influenza; Malaise; Myalgia	FLU3~PFIZER\WYETH~361928~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0060268	03/04/1994	MA	22.0	22		M	12/10/1993	2NOV93 pt recvd vax & 3NOV93 felt cold coming on, sl sore throat, & malaise; 4NOV93 tenderness under arm pit; all sx cont until 8NOV93; @ which time all better;									Y	11/02/1993	11/03/1993	1	NONE	PVT	PVT	NONE	NONE	jaundice/hepatitis 1992	~ ()~~~In patient		1						1	Malaise; Pain; Pharyngitis; Rhinitis	FLU3~PFIZER\WYETH~361928~1~IM~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0060269	03/04/1994	MA	20.0	20		F	12/10/1993	pt devel nausea, myalgia, h/a, chills on 28OCT93 & 29OCT(3 in the evening had 3 episodes of vomiting; 30OCT93 had a bad h/a 31OCT93 all sx had resolved;									Y	10/28/1993	10/28/1993	0	NONE	PVT	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Chills; Headache; Myalgia; Nausea; Vomiting	FLUX~PFIZER\WYETH~4938083~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060270	03/04/1994	MA	23.0	23		F	12/10/1993	29OCT93 devel a h/a frontal pain; h/a resolved when Advil was taken; h/a cont until 2NOV93;									Y	10/28/1993	10/29/1993	1	NONE	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Headache	FLUX~PFIZER\WYETH~4938083~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060271	03/04/1994	MA	44.0	44		F	12/10/1993	pt devel red blotchy itchy rash over entire back, abdo, chest, upper arms; It was resolved in 4-5 days;									Y	10/30/1993	10/31/1993	1	NONE	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Pruritus; Rash maculo-papular	FLU3~PFIZER\WYETH~361928~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0060272	03/04/1994	MA	36.0	36		F	12/10/1993	pt devel severe h/a which lasted until 1NOV93; p/taking medication sx resolved;									Y	10/28/1993	10/28/1993	0	NONE	PVT	PVT	NONE	mild h/a	hx of migraines for past 1 year;	~ ()~~~In patient		1						1	Condition aggravated	FLUX~PFIZER\WYETH~4938083~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060273	03/04/1994	MA	26.0	26		F	12/10/1993	10NOV93 recvd vax;  11NOV93 very sore throat, bad h/a, stuffy post nasal drip;									Y	11/10/1993	11/11/1993	1	NONE	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Headache; Pharyngitis; Rhinitis	FLU3~PFIZER\WYETH~361928~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0060274	03/04/1994	MA	47.0	47		F	12/10/1993	5NOV93 devel sore throat & h/a through 15NOV93 had flu like sx including malaise, sore throat & upper resp sx; sx cont for approx 4 wks;									Y	11/02/1993	11/05/1993	3	NONE	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Headache; Influenza; Malaise; Pharyngitis	FLU3~PFIZER\WYETH~361928~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0064550	03/04/1994	IN				U		pt recvd vax & devel redness, swelling & warmth in the arm of inject;									U					OTH	OTH				~ ()~~~In patient	893300005C	1						1	Oedema peripheral; Vasodilatation	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060282	03/07/1994	ID	56.0	56		F	01/25/1994	pain began rt breast area then moved to other areas most prominent on knees bright red rash which spread to different areas of body; cough treated w/Pred;				Y					N	12/15/1993	12/21/1993	6	biopsy which showed vasculitis, CXR, blood work & UA;	PVT	PVT	Premarin	NONE	NKA	~ ()~~~In patient	ID94004	1						1	Arthralgia; Breast pain; Cough; Rash; Vasculitis	FLU3~CONNAUGHT LABORATORIES~4938163~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0060283	03/07/1994	ID	47.0	47		M	01/25/1994	redness of face, skin peeled-progressed to other parts of the body; dry scaling, peeling sking 3 different MD's have used pred, erythromycin, Lidex, triamcinolone; dx of effoliative erythederma;				Y					N	10/26/1993	12/01/1993	36		PUB	PUB	NA	NONE	NONE	~ ()~~~In patient	ID94005	1						1	Dermatitis exfoliative; Dry skin; Vasodilatation	FLUX~PFIZER\WYETH~4938226~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060287	03/07/1994	ID	83.0	83		M	02/07/1994	hospitalized 26NOV92 to 21DEC93 presenting w/parasthesia & weakness; dx w/GBS requiring mechanical ventilation and plasmapheresis;			Y		Y	25			Y	10/01/1993	11/19/1993	49		PVT	PVT	Voltaren, Vanceril	NONE	osteoarthritis, asthma;	~ ()~~~In patient	ID94009	1						1	Asthenia; Guillain-Barre syndrome; Paraesthesia; Respiratory disorder	FLUX~PFIZER\WYETH~4938156~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0060319	03/07/1994	IA	72.0	72		F	03/04/1994	pt recvd flu vax 15OCT93; bruised area noted 22OCT93; herpes zoster entire lt arm & forearm medial side of lt arm & forearm 24OCT93 dx 25OCT93;									Y	10/15/1993	10/24/1993	9	NONE	PVT	PVT	Dyazide, Synthroid, Lanoxin, Premarin, Hydralazine, Amitryptline;	NONE	allergic to Ampicillin	~ ()~~~In patient		1						1	Ecchymosis; Herpes zoster	FLUX~PFIZER\WYETH~4938217~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060374	03/08/1994	NV	69.0	69		F	12/13/1993	4 days p/inject had hives; was seen @ urgent care; many tests including CAT Scan were performed; given dx of Bell's Palsy & hives; taking DPH;				Y					Y	10/01/1993	10/05/1993	4	unk	PUB	UNK	numerous heart	NONE		~ ()~~~In patient	NV94003	1						1	Facial palsy; Urticaria	FLUX~PFIZER\WYETH~4938153~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060375	03/08/1994	NV	64.0	64		F	02/04/1994	w/in 1 mo of having flu pt starting w/burning gums, nasal, resp congestion; since 30NOV93 lost strength in lt hand; 17JAN94 pain in lt chest, total chest & breast pain moved to rt had problems has seen 4 MD;				Y					N	10/21/1993	11/20/1993	30	EKG V/A CXR; spinal CBC in RA;	PUB	PVT	NONE	NONE	many allergic: PNC ant anti inflamation, codeine;	~ ()~~~In patient	NV94004	1						1	Breast pain; Chest pain; Gingivitis; Lung disorder; Myasthenic syndrome; Pain; Rhinitis	FLUX~PFIZER\WYETH~4938153~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060378	03/08/1994	CA	53.0	53		F		lt arm inflamed from inject site down; upper & lower muscle pain; eruption from inject site; pain since OCT93; heat applied x-10x daily; loss of strength in hand & arm;									N	10/27/1993	10/29/1993	2		OTH	UNK				~ ()~~~In patient		1						1	Injection site inflammation; Myalgia; Myasthenic syndrome; Pain	FLUX~PFIZER\WYETH~4938177~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060391	03/09/1994	KY	58.0			M	02/28/1994	GBS about 6 wks after flu shot given; required plasma exchange x4; intubation; rehabilitation;					Y	40			Y					PUB	UNK			hypertension, lumbar disc disease;	~ ()~~~In patient		1						1	Guillain-Barre syndrome; Respiratory disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0057615	03/11/1994	VT	28.0	28		F	10/26/1993	pt recvd vax 19OCT93 & 5 hrs later devel a raised, red area in the arm of inject; 16 to 18 hrs p/vax devel tachycardia 9130-160BPM, SOB, & chest pain; pt was observed in ER for 5 hrs & chest pain resolved;				Y					Y	10/19/1993	10/20/1993	1		PVT	PVT	oral contraceptives;	NONE	renal disease; patient on dialysis; allergy to sulfa drugs;	~ ()~~~In patient	893309003J	1						2	Chest pain; Dyspnoea; Injection site hypersensitivity; Injection site mass; Tachycardia	FLUX~PFIZER\WYETH~4938151~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0060408	03/11/1994	NY				M	10/14/1993	Pt recvd flu vax & devel low grade fever, malaise, runny nose & cough;									U					OTH	OTH	unk	unk		~ ()~~~In patient	893308002J	1						1	Cough; Malaise; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060409	03/11/1994	NY				U	10/14/1993	Pt recvd flu vax & pt devel low grade fever, malaise, runny nose & cough;									U					OTH	OTH	unk	unk		~ ()~~~In patient	893308003J	1						1	Cough; Malaise; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060410	03/11/1994	NY				U	10/14/1993	Pt recvd flu vax & pt devel low grade fever, malaise, runny nose & cough;									U					OTH	OTH	unk	unk		~ ()~~~In patient	893308004J	1						1	Cough; Malaise; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060411	03/11/1994	NY				U	10/14/1993	pt recvd flu vax & pt devel low grade fever, malaise, runny nose & cough;									U					OTH	OTH	unk	unk		~ ()~~~In patient	893308005J	1						1	Cough; Malaise; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060412	03/11/1994	NY				U	10/14/1993	pt recvd flu vax & pt devel low grade fever, malaise, runny nose & cough;									U					OTH	OTH	unk	unk		~ ()~~~In patient	893308006J	1						1	Cough; Malaise; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060413	03/11/1994	KS	36.0	36		F	10/25/1993	pt recvd flu vax & arm felt itchy & hot to the touch, & inject site became red & swollen; pt states did not feel well for about a wk;									Y	10/19/1993	10/20/1993	1		OTH	OTH	unk	NONE	epilepsy; asthma; allergic to codeine;	~ ()~~~In patient	893308007J	1						1	Injection site hypersensitivity; Injection site oedema; Malaise; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~4938191~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060414	03/11/1994	KS				F	10/25/1993	pt recvd flu vax & arm felt hot to the touch, & a 3 inch area of induration & redness devel;									U					OTH	OTH	unk	unk		pt exp similar react p/last years immun;~ ()~~~In patient	893308008J	1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060415	03/11/1994	MO	40.0			F	10/22/1993	pt recvd flu vax on 15OCT93; 18OCT93 devel a localized fever in one breast, accompanied by soreness & hardness;				Y					U	10/15/1993	10/18/1993	3		OTH	OTH	Estratest HS	unk		~ ()~~~In patient	893309001J	1						1	Breast pain; Vasodilatation	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060416	03/11/1994	OR	45.0	45		F	10/21/1993	pt recvd flu vax 5OCT93 & 6 days later devel a lt sided h/a; MD dx idiopathic viral neuropathy;				Y					Y	10/05/1993	10/11/1993	6		OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient	893309002J	1						1	Headache; Infection; Neuropathy; Paraesthesia; Tongue disorder	FLUX~PFIZER\WYETH~4938226~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060418	03/11/1994	DC				U	10/27/1993	pt recvd flu vax & pt devel a knot, & redness @ inject site & a fever;									U					OTH	OTH	unk	unk	NONE	~ ()~~~In patient	893315007J	1						1	Injection site hypersensitivity; Injection site mass; Pyrexia	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060419	03/11/1994	DC				U	10/27/1993	Pt recvd flu vax & devel a knot, & redness @ the inject site, & a fever;									U					OTH	OTH	unk	unk		~ ()~~~In patient	893315008J	1						1	Injection site hypersensitivity; Injection site mass; Pyrexia	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060420	03/11/1994	KS	64.0	64		M	10/28/1993	pt recvd flu vax & devel redness & swelling @ the site of inject;									Y	10/27/1993	10/27/1993	0		PVT	PVT	Procardia XL; Diabinese;	unk	non-insuling dependent diabetes, hypertension	~ ()~~~In patient	893315010J	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4938118~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060421	03/11/1994	NY	53.0	53		F	11/09/1993	Pt recvd flu vax & 2 to 3 hrs later devel a 20mm area of induration which became edematous; Erythematous papules (which MD stated looked like shingles) devel in supraclavicular area, w/a few vesicles on the lt arm & a few macules rt leg;									Y	11/08/1993	11/08/1993	0	NONE	OTH	PUB	NONE	NONE	sensitivity to nl doses of medication;	~ ()~~~In patient	893316002J	1						1	Dermatitis bullous; Injection site mass; Injection site oedema; Pruritus; Rash maculo-papular	FLUX~PFIZER\WYETH~4938166~5~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060422	03/11/1994	MD	70.0			M	11/22/1993	pt recvd flu vax 18NOV93 & 20 hrs later was noted to be febrile, 24 hrs p/inject devel a rash on lower extremities, 49 hrs later was noted to have hematuria & proteinuria;									U	11/18/1993	11/19/1993	1		OTH	OTH	unk	venous graft infect		~ ()~~~In patient	893343007J	1						1	Albuminuria; Haematuria; Pyrexia; Rash	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060423	03/11/1994	NY	52.0	52		M	11/22/1993	pt recvd vax & 1-2 hrs later devel hives on trunk then later extremities; also exp nausea; awoke during th noc (4-430AM) feeling lightheaded, & exp a near-syncopal episode upon rising; presented to ER w/ a blood presusre 76/62;				Y					Y	11/18/1993	11/18/1993	0		PVT	PVT	Tolectin, parafon forte, propoxyphene/acetaminophen as needed;	low back pain;	lt arm amputation (1970);	NONE~ ()~~~In patient	893343008J	1						1	Dizziness; Hypotension; Insomnia; Nausea; Urticaria	FLUX~PFIZER\WYETH~4938143~3~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060424	03/11/1994	TX	60.0	60		F	11/10/1993	pt recvd vax 6OCT93; subsequently devel swelling & bruising @ inject site, & a fever which lasted for 3 days;									Y	10/06/1993				PUB	OTH	unk	unk		~ ()~~~In patient	893362009J	1						1	Ecchymosis; Injection site oedema; Pyrexia	FLUX~PFIZER\WYETH~4938118~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060425	03/11/1994	OR	49.0	49		F	12/20/1993	Pt recvd flu vax 16DEC93 & presented to ER w/severe h/a, nausea & vomiting; treated w/Fiorinal, the sx are resolving;				Y					Y	12/16/1993	12/17/1993	1		PVT	OTH	NONE	end of sinus infect		~ ()~~~In patient	894004002J	1						1	Headache; Nausea; Vomiting	FLUX~PFIZER\WYETH~4938187~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060442	03/11/1994	WA	70.0	70		M	03/06/1994	partial deafness, rt ear, subsequent ringing 9-10NOV, weak, fever 98-101; 11-16NOV whipsaw fever, 103-6, single sided h/a, lt median & frontal lobes; cramps in esophagus; could not eat solid food for several weeks; weight loss, burning eye;									Y	11/02/1993	11/08/1993	6	10DEC chemical panel, serum, urinalysis; everything nl x/PSA 3.77;	PVT	PVT	NONE	NONE	NONE	pt exp lumbago @ 53 y/o w/flu vax fall of 1976;~ ()~~~In patient		1						1	Angina pectoris; Anorexia; Asthenia; Deafness transitory; Oesophagitis; Pyrexia; Tinnitus; Weight decreased	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060624	03/11/1994	MA	85.0			F	12/07/1993	Pt recvd vax & 10 to 14 days later devel herpes zoster; pt was treated w/Zovirax 4 times daily for 5 days & sx abated;				Y					Y	10/29/1993	11/18/1993	20		OTH	PUB	Synthroid, Multivitamins w/iron;	unk		~ ()~~~In patient	893362005J	1						1	Herpes zoster	FLUX~PFIZER\WYETH~4938084~UNK~SC A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058881	03/14/1994	MO	23.0	23		F	01/03/1994	27OCT94 lip drooping & eye tearing; water runs out of mouth: dx Bells palsey;									Y	10/25/1993	10/27/1993	2		OTH	OTH	NONE	NONE	Meniere's Disease & allergies;	NONE~ ()~~~In patient		1						2	Facial palsy; Hypotonia; Lacrimal disorder; Facial palsy; Hypotonia; Lacrimal disorder	FLUX~PFIZER\WYETH~4938186~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938186~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058934	03/14/1994	CO	35.0	35		M	02/10/1994	Because the shot being put in lt deltoid muscle the inflamation has caused lt arm to be partially paralyzed; pt had 4 MD visits & PT; pt states still very painful & cannot work;				Y					N	11/01/1993	11/01/1993	0		PVT	PVT		NONE	NONE	pt exp rxn @ 35 y/o w/flu vax;~ ()~~~In patient	CO93095	1						2	Hypokinesia; Pain; Monoplegia; Pain	FLU3~CONNAUGHT LABORATORIES~3F41027~4~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~3F41007~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0060617	03/14/1994	IA	45.0	45		F	11/23/1993	Pt recvd flu vax & 19NOV93 later that day pt exp muscle aches, h/a & abdo pain; 3 days later was dizzy;									Y	11/19/1993	11/19/1993	0		OTH	PVT	unk	NONE	The pt has hayfever, & is allergic to molds & mildew;	~ ()~~~In patient	893336001C	1						1	Abdominal pain; Dizziness; Headache; Myalgia	FLUX~PFIZER\WYETH~4938183~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060618	03/14/1994	ID	45.0			M	11/18/1993	Pt recvd vax & 4 days later ex shaking & tremors which lasted 5 mins; noted a dime-sized area of redness @ inject site w/subsequent sloughing of the sking;									U	11/11/1993	11/15/1993	4		OTH	OTH	NONE	unk		~ ()~~~In patient	893328008C	1						1	Dermatitis exfoliative; Injection site hypersensitivity; Tremor; Injection site hypersensitivity; Injection site necrosis; Movement disorder; Tremor	FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~3F41027~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0060619	03/14/1994	PA				M	11/26/1993	Pt recvd vax on 23NOV93 & 2 days later devel myalgia & a mild fever (100-101);									U	11/23/1993	11/25/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	893343001J	1						1	Myalgia; Pyrexia	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060620	03/14/1994	NJ	71.0	71		M	11/22/1993	Pt recvd vax 25OCT93 & 1 to 2 days later devel soreness & itching @ the site of inject; also exp joint pains in the shoulder, arms & pelvis for 2 wks; 29NOV93 all sx abated;									Y	10/26/1993	10/27/1993	1		OTH	OTH	unk	Cold	mild allergies to food, tree pollen, mold, dust, & aromatic oils;	~ ()~~~In patient	893343002J	1						1	Asthenia; Injection site pain; Pain; Pruritus; Tenosynovitis	FLUX~PFIZER\WYETH~4938152~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060621	03/14/1994	TX	36.0	36		M	11/24/1993	pt recvd vax & 6 wks later when pt went to the blood bank to donate blood, routine testing showed the test for HTLV-1 to be pos/indeterminate;									U	10/12/1993	11/23/1993	42		PUB	OTH	NONE	unk		~ ()~~~In patient	893343003J	1						1	Laboratory test abnormal	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060622	03/14/1994	CA	75.0			M	11/21/1993	Pt recvd vax & 2 days later had nose pain which progressed to jaw pain; pt was seen by MD who advised to take APAP;									U	11/16/1993	11/18/1993	2		OTH	OTH	ASA, Vitamins	unk	NONE	~ ()~~~In patient	893343004J	1						1	Pain	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060623	03/14/1994	NY	46.0	46		F	11/17/1993	Pt recvd vax & devel panniculitis of the supraclavicular area characterized by local swelling; dx was confirmed by MRI;									Y	10/06/1993	10/06/1993	0	07OCT93 MRI acute panniculitis of lt supraclavicular region;	PVT	OTH	unk	NONE	NONE	~ ()~~~In patient	893343005J	1						1	Cellulitis; Injection site oedema; Injection site pain; Pharyngitis	FLUX~PFIZER\WYETH~4938158~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060625	03/14/1994	MN	34.0	34		F	12/07/1993	Pt recvd vax 1NOV93 & ached all over, had a heavy feeling in the chest; had rib pain, weakness, & pale & clammy skin; 17NOV93 had a recurrence of chest pain, & elevated BP; seen by MD who treated w/fluids & rest;				Y					Y	11/01/1993	11/02/1993	1	HBG 13.4; WBC 9.2;	PVT	PVT	NONE	unk	allergy-codeine, bananas, Hep B vax;	~ ()~~~In patient	894003001J	1						1	Asthenia; Chest pain; Hyperhidrosis; Hypertension; Myalgia; Pain; Pallor; Asthenia; Chest pain; Myalgia; Pain	FLUX~PFIZER\WYETH~4938192~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938192~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0064055	03/14/1994	MO	34.0	34		F		pt recvd vax; pt devel lymphadenopathy, somnolence, conjunctivitis & neck stiffness;									U	06/15/1993	07/14/1993	29	no relevant data;	OTH	OTH	birth control pills;			~ ()~~~In patient	WAES93071039	1						1	Conjunctivitis; Lymphadenopathy; Nuchal rigidity; Somnolence	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064349	03/14/1994	NJ	43.0			M		pt recvd vax & devel flu-like sx which persisted for 1 wk; 2 wks following vax devel malaise, diarrhea, weight loss, nausea, abdo pain; seen by MD; lab eval revealed AST 43, pos stool sample;				Y					N	10/07/1993	10/21/1993	14	OCT93 SGOT 43; Stool analysis pos	OTH	OTH			allergy, bee stings;	~ ()~~~In patient	WAES93111057	1						1	Abdominal pain; Abnormal faeces; Aspartate aminotransferase increased; Diarrhoea; Influenza; Malaise; Nausea; Weight decreased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~MERCK & CO. INC.~~1~IM~~HEP B (RECOMBIVAX HB)~1	USA	Emergency room visit	Influenza
0064399	03/14/1994	TX	68.0	68		M		pt recvd vax & exp malaise, fatigue, joint pain & slept for 10 to 12 hrs per day; NOV93 was dx w/polymyalgia rheumatica; lab tests showed inc serum albumin, serum alkaline phosphatase & LDH; pt felt sx may have been related to viral infect									N	08/26/1993	11/01/1993	67	No relevant data	OTH	OTH	NONE			~ ()~~~In patient	WAES93121231	1						1	Arthralgia; Asthenia; Blood alkaline phosphatase increased; Blood lactate dehydrogenase increased; Infection; Malaise; Myalgia; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~MERCK & CO. INC.~1429V~3~IM~~HEP B (RECOMBIVAX HB)~1	USA		Influenza
0060705	03/15/1994	LA	38.0	38		F	03/11/1994	devel malaise p/vax 10 days later noted swelling of ankles assoc w/redness & warmth, t101 max; devel rash around lt ankle, then knees & elbows started hurting; dx arthus react to flu vax;				Y					Y	09/27/1993	10/07/1993	10	rheumatoid factor neg; lyme diaseas serology neg; WBC NWL; sed rate elevated; anti nuclear antibodies neg; total protein & alk phos elevated;	PVT	PVT	UNK	NONE		~ ()~~~In patient		1						1	Arthralgia; Blood alkaline phosphatase increased; Osteoarthritis; Pyrexia; Rash; Red blood cell sedimentation rate increased; Serum sickness; Vasodilatation	FLUX~PFIZER\WYETH~4938144~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0056495	03/16/1994	MI	64.0	64		M	06/18/1993	day p/vax pt exp lt arm pain-radiating from neck to elbow (inject arm) & swelling occurred & lasted up to 3 months; pt also stated that devel a sinus infect 1 day p/shot & is still troublesome;									Y	11/20/1992	11/21/1992	1		MIL	MIL	Lisinopril, Sulsalate	NONE	HTN; COPD all: PCN/Sulfa/Bee stings/Spider bites;	~ ()~~~In patient		1						2	Arthralgia; Injection site pain; Neck pain; Oedema; Sinusitis	FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058375	03/16/1994	NY	47.0	47		M	11/02/1993	pt recvd vax & devel pain, numbness & tingling in the arm of inject which extended down the forearm & into the fingers; tingling was intermittent constant numbness in the lt thumb; dx brachial plexitis;				Y					N	09/17/1993	09/19/1993	2		PVT	PVT	Zestril, ASA:	NONE	aortic valve repair & repair of dissected aortic aneurysm; hypertension;	~ ()~~~In patient	893314001J	1						2	Neuropathy; Pain; Paraesthesia	FLUX~PFIZER\WYETH~4938185~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0060625	03/16/1994	MN	34.0	34		F	11/02/1993	pt recvd flu vax & devel weakness, heavy chest, rib pain & achiness;									U	11/01/1993	11/02/1993	1		PVT	OTH	unk	unk		~ ()~~~In patient	893314002J	1						2	Asthenia; Chest pain; Hyperhidrosis; Hypertension; Myalgia; Pain; Pallor; Asthenia; Chest pain; Myalgia; Pain	FLUX~PFIZER\WYETH~4938192~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938192~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0060715	03/16/1994	VA	73.0			M		Pt exp GBS secondary to flu vax given 8OCT93; since the vax pt had exp 2-3 wks of upper body discomfort & weakness;	Y				Y		Y			10/08/1993	11/04/1993	27	CSF protein inc @ 155;	UNK	UNK	HCTZ		large cell lymphoma of abdo; dx SEP93 treated w/ 3 cycles of meds; ASCVD, MI	~ ()~~~In patient		1						1	Asthenia; CSF test abnormal; Guillain-Barre syndrome; Pain	FLUX~PFIZER\WYETH~4938167~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0060719	03/16/1994	AZ	42.0	42		F		Pt recvd vax & exp GBS; sx started 27OCT93 w/sore arm; GBS started 21FEB94 had flu sx last wk s/diarrhea & fever of 101.8; when given vax felt like fire was going up arm & walked in daze p/recvd vax;				Y					N	10/27/1993	02/21/1994	117	PE	PUB	UNK	Tenormin, Demulen for crams;	NONE	NKA	~ ()~~~In patient	AZ9409	1						1	Depersonalisation; Diarrhoea; Guillain-Barre syndrome; Influenza; Injection site pain; Myalgia; Paralysis; Pyrexia	FLUX~PFIZER\WYETH~4938186~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060764	03/16/1994	CO	34.0	34		F	10/25/1993	pt recvd vax & devel a 4 centimeter area of painful induration, redness & warmth @ the inject site;									Y	10/20/1993	10/20/1993	0		PUB	OTH	Premarin	unk		~ ()~~~In patient	893309006J	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLUX~PFIZER\WYETH~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060765	03/16/1994	MI	43.0	43		F	10/28/1993	pt recvd flu vax & 48 hrs later devel a severe h/a which lasted 24 hrs then went away on its own;									Y	10/15/1993	10/17/1993	2		PUB	PUB	NONE	NONE		~ ()~~~In patient	893309007J	1						1	Headache	FLUX~PFIZER\WYETH~4938178~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060766	03/16/1994	NJ	18.0			M	10/21/1993	Pt recvd vax & 10 to 15 mins later the pt devel an allergic react characterized by flushing, diaphoresis, & anxiety; pt was treated w/Epi & the react resolved;									Y	10/21/1993	10/21/1993	0		OTH	OTH	unk	NONE		~ ()~~~In patient	893313005J	1						1	Anxiety; Hyperhidrosis; Hypersensitivity; Vasodilatation	FLUX~PFIZER\WYETH~4938182~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060768	03/16/1994	NJ	18.0			M	10/21/1993	Pt recvd vax & 10 to 15 mins later the pt devel palpitations & dizziness; pt was observed for 35 mins & recovered;									Y	10/21/1993	10/21/1993	0		OTH	OTH	unk			~ ()~~~In patient	893313007J	1						1	Dizziness; Palpitations	FLUX~PFIZER\WYETH~4938182~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060769	03/16/1994	AL				U	10/25/1993	Pt recvd vax & devel a systemic reaction of an unspecified nature;									U	10/18/1993	10/19/1993	1		OTH	OTH	unk	unk		~ ()~~~In patient	893313008J	1						1	Unevaluable event	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060770	03/16/1994	AL				U	10/25/1993	pt recvd vax SC instead of IM; the devel redness & induration @ the inject site;									U	10/18/1993	10/19/1993	1		OTH	OTH	unk	unk		~ ()~~~In patient	893313009J	1						1	Injection site hypersensitivity; Injection site mass	FLUX~PFIZER\WYETH~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060771	03/16/1994	AL				U	10/25/1993	pt recvd flu vax SC instead of IM; pt devel redness & induration @ the inject site;									U	10/18/1993	10/19/1993	1		OTH	OTH	unk	unk		~ ()~~~In patient	893313010J	1						1	Injection site hypersensitivity; Injection site mass	FLUX~PFIZER\WYETH~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060772	03/16/1994	AL				U	10/25/1993	pt recvd flu vax SC instead of IM & pt devel redness & induration @ the inject site;									U	10/18/1993	10/19/1993	1		OTH	OTH	unk	unk		~ ()~~~In patient	893313011J	1						1	Injection site hypersensitivity; Injection site mass	FLUX~PFIZER\WYETH~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060773	03/16/1994	AL				U	10/25/1993	pt recvd flu vax SC instead of IM & pt devel redness & induration @ the inject site;									U	10/18/1993	10/19/1993	1		OTH	OTH	unk	unk		~ ()~~~In patient	893313012J	1						1	Injection site hypersensitivity; Injection site mass	FLUX~PFIZER\WYETH~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060774	03/16/1994	OK	45.0	45		F	10/27/1993	pt recvd vax & w/in 15 mins of the inject devel erythema; 2 hrs later pt devel an 18-20 cm wide vesicle on arm; sloughing resulted in superficial ulceration; also devel 8-10 cm area of eschar @ the site;				Y					U	10/17/1993	10/17/1993	0		PVT	PVT	Dilantin, Synthroid, Prozac, Dyazide, Ativan	NONE	pt has multiple medical problems, including sz disorder & hypothyroidism; also has depression;	~ ()~~~In patient	893313013J	1						1	Dermatitis bullous; Dermatitis exfoliative; Injection site reaction; Rash; Skin ulcer	FLUX~PFIZER\WYETH~4938125~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060775	03/16/1994	AR	50.0	50		F	10/26/1993	pt recvd vax & was seen in ER a few day later w/an area of erythema @ the inject site, blotchy red rash on trunk, swelling in the extremities & face; pt also reported flu sx (n&v, achiness, fever), joint swelling, malaise; phlebitis @ site;				Y					Y	10/06/1993	10/06/1993	0		PUB	OTH	NONE	unk		~ ()~~~In patient	893313014J	1						1	Face oedema; Influenza; Injection site hypersensitivity; Myalgia; Oedema peripheral; Osteoarthritis; Phlebitis; Rash maculo-papular	FLUX~PFIZER\WYETH~4938125~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060776	03/16/1994	TX				F	11/02/1993	pt recvd vax & w/in 30 mins devel a localized area of itching, redness & edema that was warm to the touch; pt was treated w/DPh; 19 other pts recvd immun from the same vial w/o any adverse reacts;									U					PVT	OTH	unk	unk		~ ()~~~In patient	893313015J	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~4938185~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060777	03/16/1994	OH	36.0	36		F	11/02/1993	pt recvd vax & 24 hrs later devel generalized hives w/pruritus; pt seen by MD who treated w/Pred & Atarax; 2 wks later devel an upper resp infect & cough;				Y					Y	10/22/1993	10/23/1993	1		OTH	OTH	Antivert, Zantac PRN, Beconase, ESGIC plus			~ ()~~~In patient	893313018J	1						1	Cough; Pharyngitis; Pruritus; Urticaria	FLUX~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060778	03/16/1994	MI	50.0	50		M	11/01/1993	pt recvd vax & 2 days later devel swelling of the legs & joint aches (except in the knees); on f/u it is noted that the pt sx were attributed to Rieters synd;									U	09/27/1993	10/19/1993	22	Sedimentation 40, 30; ANA 1:160 homogenous pattern;	PVT	OTH	unk	unk	pt has a hx of mild arthralgias;	~ ()~~~In patient	893313019J	1						1	Antinuclear antibody; Condition aggravated; Oedema peripheral; Red blood cell sedimentation rate increased	FLUX~PFIZER\WYETH~4938141~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060781	03/16/1994	MN	29.0	29		M	11/01/1993	pt recvd vax 29OCT93 & the next morning devel a pruritic, red rash on the shoulder near the inject site; rash spread from nipple to nipple & also had a rash from knee to groin; pt went to ER & was treated w/DPH for relief;				Y					U	10/29/1993	10/30/1993	1		PUB	PUB	NONE	NONE		~ ()~~~In patient	893314003J	1						1	Injection site hypersensitivity; Pruritus; Rash; Pruritus; Rash; Rash maculo-papular	FLUX~PFIZER\WYETH~4938192~5~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0060781	03/16/1994	MN	29.0	29		M	12/07/1993	pt recvd vax 29OCT93 & devel a red spotty rash on the lt side of neck, solid rash from knee to groin bilaterally & from nipple to nipple, A pruritic rash on lt shoulder;				Y					Y	10/29/1993	10/30/1993	1		PUB	PUB	unk	unk		~ ()~~~In patient	894003002J	1						2	Injection site hypersensitivity; Pruritus; Rash; Pruritus; Rash; Rash maculo-papular	FLUX~PFIZER\WYETH~4938192~5~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0060782	03/16/1994	MO	35.0	35		M	10/28/1993	pt recvd vax 22OCT93 & w/in 2 hrs devel a red, raised itchy rash from the elbow up to neck; pt subsequently exp localized redness & warmth @ the inject site; pt also had malaise, aching joints, nausea & a h/a;									Y	10/22/1993	10/22/1993	0		PUB	PUB	NONE	NONE		~ ()~~~In patient	893314005J	1						1	Arthralgia; Headache; Injection site hypersensitivity; Malaise; Nausea; Pruritus; Rash maculo-papular; Vasodilatation	FLUX~PFIZER\WYETH~4938185~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060783	03/16/1994	OK	24.0	24		F	11/05/1993	Pt recvd vax & w/in 15 mins pt devel localized burning sensation, swelling, redness @ the inject site; The area was warm to the touch; pt also exp achiness;				Y					Y	11/05/1993	11/05/1993	0		PUB	OTH	NONE	NONE		~ ()~~~In patient	893314006J	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia; Vasodilatation	FLUX~PFIZER\WYETH~4938144~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060784	03/16/1994	WI				U	11/05/1993	pt recvd vax & w/in a wk of immun pt devel hyperglycemia;									U					OTH	OTH	Insulin	unk	insulin dependent diabetes;	~ ()~~~In patient	893314007J	1						1	Hyperglycaemia	FLUX~PFIZER\WYETH~4938160~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060785	03/16/1994	WI				U	11/05/1993	pt recvd vax & w/in a wk of immun pt devel hyperglycemia;									U					OTH	OTH	Insulin	unk	insulin dependent diabetes	~ ()~~~In patient	893314008J	1						1	Hyperglycaemia	FLUX~PFIZER\WYETH~4938160~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060786	03/16/1994	WI				U	11/05/1993	Pt recvd vax & w/in a wk of immun pt devel hyperglycemia;									U					OTH	OTH	Insulin	unk	insulin dependent diabetes;	~ ()~~~In patient	893314009J	1						1	Hyperglycaemia	FLUX~PFIZER\WYETH~4938160~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060787	03/16/1994	OH	93.0			F	11/01/1993	pt recvd vax & devel paranoid delusions; pt has been given a dx of alzheimers; on f/u reporter attributes the pts react to alzheimers dissease & feels it is unrelated to flu vax;									U	10/29/1993	10/30/1993	1	CT scan cortical atrophy, consistent w/Alzheimers;	PVT	OTH	unk	unk	the pt had some memory loss prior to immun	~ ()~~~In patient	893314011J	1						1	Delusion; Dementia; Laboratory test abnormal; Paranoia	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060788	03/16/1994	NH				U	11/03/1993	pt recvd flu vax & 4 days later the pt devel vertigo & nystagmus which persisted for 5 days;				Y					U					OTH	OTH	unk	unk		~ ()~~~In patient	893314014J	1						1	Nystagmus; Vertigo	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060789	03/16/1994	FL				U	11/01/1993	pt recvd vax & exp an unspecified react;				Y					U	10/01/1993				PVT	OTH	unk	unk		~ ()~~~In patient	893314015J	1						1	Unevaluable event	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060790	03/16/1994	MA	28.0	28		F	11/03/1993	pt recvd flu vax & devel flu-like sx & supraclavicular lymphadenopathy on the side of the inject;				Y					U	10/29/1993	11/02/1993	4		PVT	OTH	NONE	unk		~ ()~~~In patient	893314016J	1						1	Influenza; Lymphadenopathy	FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060791	03/16/1994	MT	61.0	61		F		pt recvd flu vax & devel a local react characterized by redness, pain, swelling, & itching on the first day; pt also c/o of a sore throat & malaise;									U	11/04/1993	11/05/1993	1		PVT	PUB	unk	asthma	angina, asthma, allergic to PNC, morphine sulfate, & Demerol;	~ ()~~~In patient	893314017J	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Malaise; Pharyngitis; Pruritus	FLUX~PFIZER\WYETH~~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060792	03/16/1994	MN				U	11/05/1993	Pt recvd flu vax & pt exp vomiting;									U					OTH	OTH	unk	unk		~ ()~~~In patient	893314018J	1						1	Vomiting	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060793	03/16/1994	CA	20.0	20		F	11/01/1993	pt recvd vax 27OCT93 & 29OCT93 devel 2-3 inch area of redness; the next day the arm of inject was completely swollen, & the pt had numbness & tingling down to the finger tips; 31OCT93 took Vicodin w/some relief of swelling & tingling;									U	10/27/1993	10/29/1993	2		PVT	OTH	Seldane, Nelova;	unk		~ ()~~~In patient	893314019J	1						1	Injection site hypersensitivity; Lymphoedema; Oedema peripheral; Pain; Paraesthesia	FLUX~PFIZER\WYETH~4938192~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060794	03/16/1994	MD				F	10/27/1993	pt recvd vax & pt devel a knot, & redness @ the inject site, & a fever;									U	10/13/1993	10/13/1993	0		OTH	OTH	unk	unk	hx of asthma;	~ ()~~~In patient	893315003J	1						1	Injection site hypersensitivity; Pruritus; Pyrexia	FLUX~PFIZER\WYETH~4938152~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060795	03/16/1994	DC				U	10/27/1993	pt recvd vax & pt devel a knot, & redness @ the inject site, & a fever;									U					OTH	OTH	unk	unk		~ ()~~~In patient	893315004J	1						1	Injection site hypersensitivity; Injection site mass; Pyrexia	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060796	03/16/1994	MD	50.0			F	10/27/1993	pt recvd flu vax & devel a knot & redness @ the inject site, & a fever;									U					OTH	OTH	unk	unk	pt has lupus;	~ ()~~~In patient	893315005J	1						1	Injection site hypersensitivity; Pruritus	FLUX~PFIZER\WYETH~4938152~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060797	03/16/1994	DC				U	10/27/1993	pt recvd vax & pt devel a knot & redness @ the inject site, & a fever;									U					OTH	OTH	unk	unk		~ ()~~~In patient	893315006J	1						1	Injection site hypersensitivity; Injection site mass; Pyrexia	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060798	03/16/1994	OR	44.0	43		F	11/10/1993	pt recvd vax 12OCT93 & 2NOV93 pt devel numbness & tingling of the tongue & rt side of the mouth; progressed to right facial numbness & difficulty closing the rt eyes; MD dx Bell's Palsy on 7NOV93;				Y					U	10/12/1993	11/02/1993	21		PVT	PVT	Calan SR, Maxzide	unk	pt has hypertension; No known allergies;	~ ()~~~In patient	893322001J	1						1	Facial palsy; Paraesthesia; Paraesthesia oral	FLUX~PFIZER\WYETH~~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060799	03/16/1994	FL	47.0	47		F	11/09/1993	pt recvd vax 14OCT93 & 7NOV93 devel generalized muscle weakness, nausea & faituge; pt did not seek medical treatment; As of 12NOV93 the pt had recovered, & was able to return back to work; pt felt the weakness was related to other problems;									Y	10/14/1993	11/07/1993	24		PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient	893322002J	1						1	Asthenia; Myasthenic syndrome; Nausea	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060800	03/16/1994	CA	53.0	53		M	11/15/1993	Pt recvd vax & devel a horrendous bowel & gut ache, weakness, fatigue, nausea, rhinorrhea, sweating, h/a, neck soreness & all over body ache, & tenderness in the lower back & thigh; pt had strange dreams, unable to think clearly				Y					U	10/11/1993			EKG-nl;	PVT	PVT	Motrin	unk	history of back injury; prev recvd flu vax in 1989 & 1992;	~ ()~~~In patient	893322003J	1						1	Abdominal pain; Abnormal dreams; Asthenia; Back pain; Headache; Myalgia; Neck pain; Thinking abnormal	FLUX~PFIZER\WYETH~~3~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060801	03/16/1994	WA	50.0	50		F	11/15/1993	pt recvd vax 3NOV93 & w/in 24 hrs devel pain in the arm & shoulder on the side of inject; also had severe lumbar/sacral pain, unrelieved by Advil or APAP, neck pain, joint pain, myalgia, a dull h/a & tiredness; 36 hrs later had a t102;									Y	11/03/1993	11/03/1993	0		PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient	893322004J	1						1	Arthralgia; Asthenia; Back pain; Cough; Headache; Neck pain; Pharyngitis; Vomiting	FLUX~PFIZER\WYETH~4938156~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060802	03/16/1994	NV	38.0			F	11/15/1993	pt recvd vax & 2 hrs later stomach bloated, pt exp nausea, diarrhea, & was hot & sweaty & devel itching w/o rash; these events were felt to be unrelated to the vax;									Y	11/15/1993	11/15/1993	0		OTH	OTH	unk	unk	NONE	~ ()~~~In patient	893322006J	1						1	Abdominal distension; Diarrhoea; Hyperhidrosis; Nausea; Pruritus; Pyrexia	FLUX~PFIZER\WYETH~4938278~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060803	03/16/1994	NY	44.0	44		F	11/17/1993	Pt recvd vax & devel panniculitis characterized by a fever & swelling;									Y	10/01/1993	10/01/1993	0		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	893343006J	1						1	Cellulitis; Myalgia; Oedema; Pyrexia	FLUX~PFIZER\WYETH~4938158~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060805	03/16/1994	IL	43.0	43		F	11/29/1993	pt recvd vax & devel numbness, tingling & aching in the arm of inject; uric acid levels became elevated; pt was treated w/an unspecified medication & sx are resolving;				Y					U	09/28/1993	09/28/1993	0		PUB	OTH	Lasix, Synthroid, Zestril, Cardura;	NONE	Hx od asthma & hypertension;	~ ()~~~In patient	893343010J	1						1	Hyperuricaemia; Myalgia; Pain; Paraesthesia; Pyrexia	FLUX~PFIZER\WYETH~4938254~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060806	03/16/1994	IL	52.0	52		F	11/29/1993	pt recvd vax 27OCT93; pt exp constant aching  in the arm of inject & arm felt heavy; pt was treated w/Motrin but sx cont;				Y					N	10/27/1993	11/01/1993	5		PUB	OTH	Dyazide, Capoten, Premarin, Provera, potassium K supplement, calcium;		pt has a hx of a rotator cuff tear in the arm of inject; hx of hypertension;	~ ()~~~In patient	893343011J	1						1	Myalgia; Myasthenic syndrome; Paraesthesia	FLUX~PFIZER\WYETH~4938254~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060808	03/16/1994	IL	36.0	36		F	11/29/1993	pt recvd vax & devel numbness, tingling & aching in the arm of the inject; a blister formed @ inject site; sx abated by 19NOV93;									Y	10/14/1993	10/14/1993	0		PUB	OTH	unk	NONE	NONE	~ ()~~~In patient	893343013J	1						1	Injection site hypersensitivity; Myalgia; Myasthenic syndrome; Paraesthesia	FLUX~PFIZER\WYETH~4938254~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060809	03/16/1994	NJ				U	12/03/1993	pt recvd vax & 36 hrs later the pt devel rt inguinal lymphadenopathy; pt was treated w/ATB & the problem is resolving;									U					OTH	OTH	unk	unk		~ ()~~~In patient	893343014J	1						1	Lymphadenopathy	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060810	03/16/1994	GA	41.0	41		F	11/30/1993	pt recvd vax 10NOV93 & the next day devel a rash (urticaria); pt is treating self w/Calamine lotion & DPH cream;									U	11/10/1993	11/11/1993	1		PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient	893343015J	1						1	Urticaria	FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060812	03/16/1994	CA				F	12/03/1993	pt recvd vax & devel swelling & tenderness @ the inject site; pt also devel joint pain; MD treated w/Motrin;				Y					U					OTH	OTH	unk	unk		~ ()~~~In patient	893343017J	1						1	Arthralgia; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060813	03/16/1994	CA	21.0	21		M	12/06/1993	pt recvd vax & 24 hrs later devel fever, shaking chills, nausea, vomiting & muscle contractions; these sx peaked the 3rd day p/vax then subsided; pt was treated w/OTC DPH & APAP;				Y					U	11/22/1993	11/23/1993	1		PUB	OTH	NONE	unk	pt had a similar react to Imferon IM administration;	~ ()~~~In patient	893343018J	1						1	Chills; Hallucination; Hypertonia; Myalgia; Nausea; Pyrexia; Tremor; Vomiting	FLUX~PFIZER\WYETH~4938261~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060814	03/16/1994	OH	62.0			F	12/06/1993	pt recvd vax & 3 days later devel purpura & a low platelet count; dx idiopathic thrombocytopenic purpura was made, pt was starte on Pred therapy; sx persist to the date of this report despite steroid therapy;				Y					U	10/25/1993	10/28/1993	3		PVT	OTH	NONE	unk	unk	~ ()~~~In patient	893344001J	1						1	Purpura; Thrombocytopenia; Thrombocytopenic purpura	FLUX~PFIZER\WYETH~4938147~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060815	03/16/1994	IL	74.0			F	12/09/1993	pt recvd flu vax & devel a red, bumpy, spreading over total body rash, sparing face, but accompanied by itching; pt was seen by MD & had 2 biopsies done;				Y					U					OTH	OTH	APAP & Vitamins	unk		~ ()~~~In patient	893362004J	1						1	Pruritus; Rash; Rash maculo-papular	FLUX~PFIZER\WYETH~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060816	03/16/1994	SC	20.0	20		F	11/18/1993	pt recvd vax & exp nausea, fatigue & fever which persisted for almost one wk; pt seen by MD who dx viral infection;				Y					U	11/12/1993	11/13/1993	1		PVT	OTH	NONE	NONE	pt has a hx of mononucleosis w/similar sx;	~ ()~~~In patient	893328006C	1						1	Asthenia; Infection; Nausea; Pyrexia	FLUX~PFIZER\WYETH~4938123~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060817	03/16/1994	MA	97.0			F	12/07/1993	pt recvd flu vax & devel herpes zoster; pt was treated w/Zovirax (5) time daily for 1 wk & sx abated; 1 other resident of the same facility had a similar react;				Y					Y	10/27/1993	11/10/1993	14		OTH	PUB	Digoxin, Nitroglycerin patch	unk		~ ()~~~In patient	893362006J	1						1	Herpes zoster	FLUX~PFIZER\WYETH~4938084~UNK~SC A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060818	03/16/1994	MA	82.0			F	12/07/1993	pt recvd vax & 10 to 14 days later devel herpes zoster; pt was treated w/Zovirax (5) times daily for 5 days & recovered; on other resident of the same facility had a similar react;				Y					Y	10/28/1993	11/10/1993	13		OTH	PUB	ASA, Xanax, Docusate, MOM, Maalox, Motrin;	unk		~ ()~~~In patient	893362007J	1						1	Herpes zoster	FLUX~PFIZER\WYETH~5938084~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060819	03/16/1994	NJ	52.0	52		F	11/18/1993	Pt recvd vax & 4 days later devel constipation which was accompanied by cramps; pt was also lightheaded, tired, disoriented, noted a sl inc in blood sugar levels; constipation lasted for 5 days; MD treated w/DPH & Rowasa enemas w/relief;				Y					U	10/20/1993	10/24/1993	4	BS 159	PUB	PVT	NONE	NONE	allergic to dust, cats, grass, codeine, demerol, sulfa;	~ ()~~~In patient	893328007C	1						1	Abdominal pain; Asthenia; Confusional state; Constipation; Dizziness; Hyperglycaemia	FLUX~PFIZER\WYETH~4938158~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060820	03/16/1994	MA	80.0			F	12/07/1993	pt recvd vax & 10 to 14 days later devel herpes zoster; pt was treated w/Zovirax 5 times daily for five days & sx abated; One other resident of the same facility had a similar react;				Y					Y	10/29/1993	11/10/1993	12		OTH	PUB	Digoxin, Vitamin B-12 injects, Lasix, Humulin insulin, Zantac, Lopid, Buspar;	unk		~ ()~~~In patient	893362008J	1						1	Herpes zoster	FLUX~PFIZER\WYETH~4938084~UNK~SC A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060822	03/16/1994	IL	46.0	46		F	09/26/1993	pt recvd flu vax on 24SEP93 & felt extremely tired for 2 days;									Y	09/24/1993	09/25/1993	1		OTH	PVT	unk	unk	NONE	~ ()~~~In patient	894003003J	1						1	Asthenia	FLUX~PFIZER\WYETH~4938142~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060823	03/16/1994	IL	63.0	63		F	10/26/1993	pt recvd vax 22SEP93; pt devel soreness in the arm of inject; w/in 2 days also devel a cough which lasted for 3-4 wks;									Y	09/22/1993	09/25/1993	3		OTH	PVT	Diabenese	unk	diabetes, no allergies	~ ()~~~In patient	894003004J	1						1	Cough; Myalgia	FLUX~PFIZER\WYETH~4938142~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060824	03/16/1994	MA	67.0	67		F	12/07/1993	pt recvd flu vax & c/o muscle soreness & nausea for 2 wks;									Y	10/19/1993	10/19/1993	0		OTH	OTH	unk	unk	NONE	pt exp arthralgia, chills, sore throat @ 66 y/o w/flu~ ()~~~In patient	894003005J	1						1	Myalgia; Nausea	FLUX~PFIZER\WYETH~4938083~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060825	03/16/1994	IL	31.0	31		F	10/26/1993	pt recvd vax 23SEP93 & devel rhinorrhea & a cough which lasted 2 wks;									Y	09/23/1993	09/25/1993	2		OTH	PVT	Amitriptylene, Birth control pills;	unk	NONE	~ ()~~~In patient	894003006J	1						1	Cough; Rhinitis	FLUX~PFIZER\WYETH~4938142~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060826	03/16/1994	IL	43.0	43		F	08/26/1993	pt recvd vax 23SEP93 & devel soreness @ the inject site, nausea, dizziness which lasted for 3 days;									Y	09/23/1993	09/24/1993	1		OTH	PVT	unk	unk		~ ()~~~In patient	894003007J	1						1	Dizziness; Injection site pain; Nausea	FLUX~PFIZER\WYETH~4938142~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060827	03/16/1994	IL	33.0	33		F	08/26/1993	pt recvd vax 23SEP93 & 2 days later devel achiness, rhinorrhea, cough & a low grade fever which lasted for 2 days;									Y	09/23/1993	09/25/1993	2		OTH	PVT	unk	sl cough, sore throat		~ ()~~~In patient	894003008J	1						1	Cough; Myalgia; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~4938142~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060828	03/16/1994	IL				F	12/17/1993	pt recvd vax 20OCT93 & devel intense upper lt body quad pain; pt took relafen w/some relief; work-up including x-rays has been unrevealing & neuro had r/o a pinched or trapped nerve;				Y					N	10/20/1993	10/22/1993	2		OTH	OTH	unk	unk		~ ()~~~In patient	894004001J	1						1	Arthritis; Pain; Paraesthesia	FLUX~PFIZER\WYETH~~4~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060829	03/16/1994	VA	33.0	33		F	12/16/1993	pt recvd vax 27OCT93 & 29OCT93 devel a h/a, nasal stuffiness hwich were treated w/Ornade & Ceftin; 8NOV93 & devel paralysis on lt side of face; MD dx Bell's Palsy & felt this was related to flu vax; pt is undergoind physical therapy & elec;				Y					U	10/27/1993	10/29/1993	2		PUB	OTH	Naprosyn, Ornade, Ceftin	unk		~ ()~~~In patient	894004003J	1						1	Facial palsy; Headache; Rhinitis	FLUX~PFIZER\WYETH~4938143~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060830	03/16/1994	NJ	52.0	52		F	12/22/1993	pt recvd vax 20NOV93 & approx 16 days later devel swelling, heat & pain in knees, ankles & wrists; pt was seen by MD who prescribed anti-inflammatory drugs which resulted in dec swelling & pain; hands still numb; dx carple tunnel synd;				Y					Y	03/20/1993	12/06/1993	261	EMG-consistent w/Carple Tunnel Synd;	OTH	OTH	NONE	NONE		~ ()~~~In patient	894021001J	1						1	Arthralgia; Osteoarthritis; Paraesthesia; Tenosynovitis; Vasodilatation	FLUX~PFIZER\WYETH~4938182~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0058205	03/17/1994	CA	61.0	61		M	01/10/1994	Pt recvd vax 27OCT93 & on 29OCT93 devel generalized weakness & felt sick; pt was seen by primary care MD & a company physician @ that time; 17NOV93 again reported generalized weakness, paresthesia & sl numbness in the rt foot; dx GBS;				Y	Y	5		Y	U	10/27/1993	10/29/1993	2		OTH	PVT	Mexitil (secondary suspect) 150 mg daily, Anaprox DN, Procardia, Vaseretic, K-Dur;	unk	pt has a hx of high blood pressure & tachycardia;	~ ()~~~In patient	894032009J	1						2	Asthenia; Coordination abnormal; Guillain-Barre syndrome; Hyperaesthesia; Hypertension; Hyporeflexia; Myasthenic syndrome; Paraesthesia	FLUX~PFIZER\WYETH~4938192~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation,Disabling	Influenza
0060748	03/18/1994	HI	56.0	56		F	02/28/1994	Pt stated that on 11NOV93 began having h/a & pain & weakness to rt hip & leg; sx progressed so on 16NOV93 went to MD c/o h/a, muscle-tension or migraine; r/o brain tumor; rt leg pain; due to lumbar radiculopathy; elevated BP;				Y					Y	11/08/1993	11/11/1993	3	elevated BP; elevated bilirubin & LDH;	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	HI946	1						1	Arthralgia; Blood lactate dehydrogenase increased; Headache; Hyperbilirubinaemia; Hypertension; Migraine; Neuropathy; Pain	FLU3~CONNAUGHT LABORATORIES~3F41001~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0059430	03/21/1994	PA	34.0	34		M	03/17/1994	GBS; onset unknown;									U	10/25/1993				OTH	PVT				~ ()~~~In patient	CO5305	1						2	Guillain-Barre syndrome; Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~3F41034~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~3F41034~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0060851	03/21/1994	MD	41.0	41		F	11/18/1993	c/o soreness @ site immed p/vax & w/in 24 hrs c/o site was sorer, red, hot to touch, swollen & hard approx 4x2 oval area; Is able to move arm but it hurts when raises it only;									Y	11/16/1993	11/17/1993	1		PUB	PUB	NONE	NONE	NKA	NONE~ ()~~~In patient	MD93055	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41035~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0060854	03/21/1994	MD	54.0	54		F	01/06/1994	coughing productive began 1 wk ago green now; can't sleep because of drainage in back throat, mild fever lt side below shoulder blade throbbing; SOB; referred to ER;										12/20/1993	12/27/1993	7	NONE	PUB	PUB	NONE	NONE	emphyzema;	unk~ ()~~~In patient	MD94003	1						1	Cough; Dyspnoea; Insomnia; Pain; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~3F41122~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1474W~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0060855	03/21/1994	MD	71.0	71		M	01/05/1994	sore throat 1wk hoarse, chest congestion persisted called MD prescribed ATB  10 days;									Y	10/19/1993	10/31/1993	12		PUB	PUB	ASpirin; Nitrobid;	NONE	NONE	NONE~ ()~~~In patient	MD94004	1						1	Dysphonia; Lung disorder; Pharyngitis	FLUX~PFIZER\WYETH~4938146~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060856	03/21/1994	MD	69.0	69		F	01/05/1994	sore throat for 1 wk-hoarse, cough; called MD ATB prescribed for 10 days;									Y	10/19/1993	10/30/1993	11		PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MD94005	1						1	Cough; Dysphonia; Pharyngitis	FLUX~PFIZER\WYETH~4938146~6~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060858	03/21/1994	MD	55.0	55		F	11/08/1993	dime size reddness @ site of inject rt arm; reddness swelling inc to 3x 4 on arm-duration of sx lasted until 6NOV93; no itching or pain;									Y	11/04/1993	11/04/1993	0	NONE	PUB	OTH	Timoxifen	NONE	allergy to PCN	NONE~ ()~~~In patient	MD94011	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~3F41027~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0060864	03/21/1994	MI	53.0	52		F	10/22/1993	15OCT93 t103, aching, hypersensitivity & chest pain went to hosp 15OCT93; CXR, infection;				Y					Y	10/15/1993	10/15/1993	0		PUB	PUB		NONE	no chronic hlth problems x/sl heart murmur;	~ ()~~~In patient	MI94023	1						1	Chest pain; Hyperventilation; Infection; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~4938183~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060867	03/21/1994	MI	7.0	7		F	01/11/1994	Day p/vax recvd pt c/o achy joint; later in day local react @ inject site noted; 5 cm area redness, hot to touch, tender, somewhat swollen; approx 2-3 days later arm became itchy, was gone approx 5 days p/first noticed;									Y	11/19/1993	11/20/1993	1	NONE	PUB	PUB	Tavist, Benylin, Asthmacort, Sudafed, Intal Nebulizer;	NONE	sulfa & erythromycin allergy-hx asthma;	NONE~ ()~~~In patient	MI94026	1						1	Arthralgia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~4938278~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060868	03/21/1994	MI	82.0	82		F	02/01/1994	macular rash devel below inject site day of immun; progressed down to wrist then to other arm; seen by PP 4OCT93 dx as react to flu vax; given topicort cream & DPH; rash resolved;				Y					Y	10/01/1993	10/01/1993	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MI94027	1						1	Rash maculo-papular	FLUX~PFIZER\WYETH~4938142~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0060896	03/21/1994	WA	50.0	50		F	01/05/1994	2-3 days p/inject & for several days pt exp nausea, aches & pains & fever; This resulted in time loss from work; pt was sick from 14NOV93 - 17NOV93;									Y	11/12/1993	11/14/1993	2		PVT	UNK		NONE		~ ()~~~In patient	WA94995	1						1	Malaise; Myalgia; Nausea; Pain; Pyrexia	FLUX~PFIZER\WYETH~49382226~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060901	03/21/1994	WA	61.0	61		F	10/13/1993	w/in 2-3 hrs devel h/a nausea, vomiting, chills, fever;									Y	10/11/1993	10/11/1993	0	NONE	PUB	PUB		NONE	NONE	NONE~ ()~~~In patient	WA941000	1						1	Chills; Headache; Nausea; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~00963P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0060903	03/21/1994	WA	51.0	51		F	01/21/1994	1 hr following vax pt exp swelling & redness @ site of inject; The following day the swelling @ the site was the size of a baseball according to pt;									Y	01/18/1994	01/18/1994	0	NONE	PUB	PVT	Medihaler, Premarin, Provera;	NONE	NONE	NONE~ ()~~~In patient	WA941001	1						1	Injection site hypersensitivity; Injection site oedema; Oedema	FLU3~PFIZER\WYETH~361921~1~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|PPV~PFIZER\WYETH~366963~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0060907	03/21/1994	WA	61.0	60		M		aching, h/a on 20DEC93 (phone call); 22DEC93 afebrile, weak, faitgued, elevated Bp @ home;					Y				Y	12/06/1993	12/17/1993	11		PVT	PVT	Hytrin	NONE	hypertension	~ ()~~~In patient	WA941006	1						1	Asthenia; Condition aggravated; Headache; Myalgia	FLU3~PARKE-DAVIS~00763P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0060915	03/21/1994	WA	37.0	37		M	01/24/1994	pt exp flu vax 18JAN94 445PM & 11PM itched all over next day low grade fever AM; eve-chills fever 103.5, plugged sinuses, nasal drainage, sore throat; had flu vax 2 yrs ago-itchiness only;									Y	01/18/1994	01/18/1994	0		PUB	PUB	NONE	denies	chronic sinus problems-dust, mold-sesensitization;	NA~ ()~~~In patient	WA941014	1						1	Chills; Pharyngitis; Pruritus; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~4938226~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060936	03/21/1994	CA	55.0	55		F	02/09/1994	fever, sore throat, malaise x 4 days p/flu shot;									Y	10/01/1993	10/01/1993	0	NONE	PVT	PVT	Premarin/Vit	NONE	NONE	NONE~ ()~~~In patient		1						1	Malaise; Pharyngitis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0059886	03/22/1994	CA	59.0			M	02/16/1994	onset of numbness, tingling of legs, arm that progressed to paraplegia;					Y		Y		N	11/23/1993	12/07/1993	14	spinal fluid analysis, CBC;	PVT	UNK		NONE	parkingson's	~ ()~~~In patient		1						2	Guillain-Barre syndrome; Paraesthesia; Paraplegia	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0060949	03/22/1994	CA	56.0	56		F	03/14/1994	pain w/in 24 hrs of vax inc in intensity-reported to clinc 3-4 days later; pt exp cellulitis, arthritic changes (nothing acute); dx tendinitis; pain cont to intensify w/limited mobility of the arm interfering w/ability to sleep;				Y					U	09/22/1993	09/23/1993	1	MRI; Sed rates; CBC, uric acid, ANA;	PVT	PVT	Synthroid; Premarin;	NONE	horseserum, no deficits, osteoarthritis;	pt exp paralysis @ 8 w/horseserum 1st;~ ()~~~In patient		1						1	Arthralgia; Headache; Hypokinesia; Insomnia; Neck pain; Osteoarthritis; Pain; Tenosynovitis; Unevaluable event	FLUX~PFIZER\WYETH~4938186~1~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938186~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0060991	03/24/1994	SD	46.0	45		F	02/02/1994	suffered permanent? hearing loss in rt ear w/in a few days of shot; dizziness & ringing in ears that is getting better;				Y	Y	1			U	10/13/1993	10/16/1993	3	Audiogram;	PUB	PUB		NONE	allergic to codiene & PCN;	~ ()~~~In patient	SD94004	1						1	Deafness; Dizziness; Infection; Tinnitus	FLUX~PFIZER\WYETH~4938180~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0059126	03/25/1994	IL	69.0	68		F	03/07/1994	pt recvd vax 16NOV93 & devel a react @ the site of pnu-imune inject which progressed to severe pain & was eventually dx as neuritis; pt devel hematemesis & was adm to hosp 28NOV93; endoscopy revelaed an acute gastric ulcer;					Y	3			U	11/16/1993	11/28/1993	12	MRI: questionable torn rotator cuff endoscopy: gastric ulcer;	PVT	PVT	unspecified H-2 blocker;	NONE	chronic obstructive pulmonary disease; hypertension, chronic paroxismal atrial tachycardia; no hx of pneumonia;	~ ()~~~In patient	894073002A	1						2	Chest pain; Gastric ulcer; Injection site pain; Laboratory test abnormal; Melaena; Neck pain; Neuritis; Pain; Gastric ulcer; Haematemesis; Injection site pain; Laboratory test abnormal; Neuritis	PPV~PFIZER\WYETH~364982~1~IM~LA~PNEUMO (PNU-IMUNE)~1|FLUX~PFIZER\WYETH~4938262~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~PFIZER\WYETH~364982~1~IM~LA~PNEUMO (PNU-IMUNE)~2	USA	Hospitalisation	Influenza
0061009	03/25/1994	IL	69.0	69		M	03/21/1994	GBS; hospitalized 5 days p/vax;					Y				U	10/29/1993	11/03/1993	5		MIL	MIL			hx of CA of tongue: recovering from radical neck dissection @ time of immun;	~ ()~~~In patient	CO5306	1						1	Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0061010	03/25/1994	NY	33.0			F	03/09/1994	Pt recvd vax & 8 days later had a stroke; Pt has recovered fully; MD attribute the stroke to a congenital weakness of the lt cartid artery & a subsequent dissection;					Y				Y					OTH	OTH	unk	unk	pt has a congenital weakness of the lt carotid artery;	~ ()~~~In patient	894073001A	1						1	Cerebrovascular accident; Condition aggravated; Cerebrovascular accident	FLU3~CONNAUGHT LABORATORIES~~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~PFIZER\WYETH~~1~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~2	USA	Hospitalisation	Influenza
0061058	03/28/1994	NY	69.0	69		F	03/09/1994	approx 1 month p/flu vax, painful stiff neck, pain lt leg, lt foot drop; neurological tests indicated neuro disease; spinal tap hos dx A-myotrophic lateral sceloris (ALS); JUL93 lt side nerve degeneration & speech affected; also devel itch	Y		Y	Y	Y	7		Y	N	10/12/1992	11/12/1992	31	EMG, 14MAY93; EMG log #93-463;	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Apnoea; Cardiac failure; Neck pain; Neuropathy; Nuchal rigidity; Peroneal nerve palsy; Pruritus; Speech disorder; Gait disturbance; Influenza; Neck pain; Neuropathy; Nuchal rigidity; Peroneal nerve palsy	FLU3~PFIZER\WYETH~337916~1~A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|FLU3~LEDERLE LABORATORIES~337916~UNK~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~2	USA	Results in Death	Influenza
0061110	03/30/1994	TX	39.0			M	01/24/1994	Began to have weakness rt hand & leg; fatigue 23DEC93 weakness progressed; hospitalized 27DEC93; dx w/GBS 28DEC; recovery is slow involving physical therapy & rest & chronic diarrhea on 12DEC93;			Y	Y	Y	7			U	10/11/1993	12/23/1993	73	Cerebrospinal fluid-clear, neg; blood test all neg;	OTH	PVT	Lozal	NONE	allergy-sulfa drugs	NA~ ()~~~In patient	TX9427	1						1	Asthenia; Diarrhoea; Guillain-Barre syndrome; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~3F41033~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0061143	03/30/1994	TX	44.0	44		M	03/02/1994	Pt states inject site started hurting next day was reddened x 2 wks; has dull pain to lt arm which radiates to hand; states can't move arm up in a fast motion; arm hurts more @ noc; states was given pain meds;				Y					U	10/28/1993	10/29/1993	1		PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	TX9462	1						1	Injection site hypersensitivity; Injection site pain; Pain	FLU3~CONNAUGHT LABORATORIES~34F1009~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~LEDERLE LABORATORIES~356906~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0061371	03/31/1994		35.0	35		M	02/02/1994	pt recvd vax & exp pain in back & lt arm has been considerable; became inflamed immed that day & have been taking anti-inflamatorys & muscle relaxants ever since; I also have been to physical therapy;								Y		11/01/1993	11/01/1993	0		UNK	UNK				~ ()~~~In patient		1						1	Back pain; Injection site inflammation; Pain	FLU3~CONNAUGHT LABORATORIES~3F41007~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0056585	04/04/1994	IN	39.0	39		F	10/05/1993	pt recvd vax & devel allergic rxn characterized by burning & swollen eyes, & a flushed, warm, & swollen face; tx benadryl;									Y	10/04/1993	10/04/1993	0		PVT	PVT	none;	none;	allergic to cats;	~ ()~~~In patient	893281005J	1						2	Eye pain; Face oedema; Hypersensitivity; Vasodilatation	FLUX~PFIZER\WYETH~4938160~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0057032	04/04/1994	MI	78.0	77		M	11/04/1993	pt recvd vax & became devel severe headache & became desoriented; pt admitted to intensive care unit w/ a dx of encephalopathy;			Y	Y	Y	12			Y	09/13/1993	09/14/1993	1		PVT	OTH				~ ()~~~In patient	893315002J	1						2	Confusional state; Encephalopathy; Headache	FLUX~PFIZER\WYETH~4938141~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation	Influenza
0064517	04/04/1994	CA	59.0	59		F	10/06/1993	pt recvd vax & devel flu-like symptoms consisting of watery eyes & runny nose, sneezing, fever, severe nausea, chills body aches & coughing; pt was dx w/ bronchitis & felt sick;				Y					U	09/23/1993	09/23/1993	0		OTH	PVT	thyroid pills;	none;	grave's disease	~ ()~~~In patient	893281002J	1						1	Bronchitis; Cough; Headache; Malaise	FLUX~PFIZER\WYETH~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0064518	04/04/1994	MA	27.0	27		F	10/07/1993	pt recvd vax & devel local swelling; pt exp also ulnar nerve pain; pt also had pain when moving arm;									U	10/04/1993	10/06/1993	2		PVT	OTH	oral contraceptives;			~ ()~~~In patient	893284001J	1						1	Injection site oedema; Neuralgia; Pain	FLUX~PFIZER\WYETH~~5~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064519	04/04/1994	NJ	41.0	41		F	10/06/1993	pt recvd vax & exp local rxn consisting of redness & pruritus at inject site; pt had an allergic rxn w/ cough & mucous,chest tightness,lightheadness, labored breathing,burning sensation & itching & numbness feeling; burning in the throat;									Y	10/04/1993	10/04/1993	0	none;	PVT	PVT	none;	none;	none;	~ ()~~~In patient	893284002J	1						1	Chest pain; Cough; Dyspnoea; Hypersensitivity; Injection site hypersensitivity; Pain; Paraesthesia; Pruritus	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064520	04/04/1994	IL				U	10/06/1993	pt recvd vax & devel redness & warmth at inject site;									U					PVT	OTH				~ ()~~~In patient	893284005J	1						1	Injection site hypersensitivity; Vasodilatation	FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064522	04/04/1994	IL				U	10/06/1993	pt recvd vax & devel redness & warmth at inject site;									U					PVT	OTH				~ ()~~~In patient	893284004J	1						1	Injection site hypersensitivity; Vasodilatation	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064523	04/04/1994	IL				U	10/06/1993	pt recvd vax & devel redness & warmth at inject site;									U					PVT	OTH				~ ()~~~In patient	893284003J	1						1	Injection site hypersensitivity; Vasodilatation	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064524	04/04/1994	IL				U	10/06/1993	pt recvd vax & devel redness & warmth at inject site;									U					PVT	OTH				~ ()~~~In patient	893284007J	1						1	Injection site hypersensitivity; Vasodilatation	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064525	04/04/1994	IL				U	10/06/1993	pt recvd vax & devel redness & warmth at inject site;									U					PVT	OTH				~ ()~~~In patient	893284006J	1						1	Injection site hypersensitivity; Vasodilatation	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064526	04/04/1994	OH				U	10/04/1993	pt recvd vax & devel redness & swelling in arm of inject; pt tx w/ atb; pt dx w/ local erythematous rxn; pt did not have cellulitis;									Y				tests were satisfactory;	PVT	OTH				~ ()~~~In patient	893285001J	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4938152~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064527	04/04/1994	NJ	70.0	69		F	10/01/1993	pt recvd vax & devel blisters at inject site;									U	09/23/1993	09/23/1993	0		PVT	PVT	Atarax;		Very sensitive to medicines according to physician;	~ ()~~~In patient	893279007C	1						1	Injection site hypersensitivity	FLUX~PFIZER\WYETH~4938167~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064528	04/04/1994	FL	15.0	15		F	10/04/1993	pt recvd vax & exp sluggishness, a swollen upper arm, & devel a 3 inch area of rednesss at inject site;									Y	10/02/1993	10/03/1993	1		PVT	PVT	none;	none;	none;	~ ()~~~In patient	893279008C	1						1	Hypokinesia; Injection site hypersensitivity; Oedema peripheral	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064529	04/04/1994	FL	43.0	43		M	10/04/1993	pt recvd vax & exp tiredness & lack of energy;									Y	10/02/1993	10/03/1993	1		PVT	PVT		none;		~ ()~~~In patient	893279009C	1						1	Asthenia	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064530	04/04/1994	FL				F	10/04/1993	pt recvd vax & exp sluggishness & devel redness at inject site;									U					PVT	PVT				~ ()~~~In patient	893279010C	1						1	Hypokinesia; Injection site hypersensitivity	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064531	04/04/1994	CA	67.0	67		F	10/01/1993	pt recvd vax & devel erythema 10x10 cm & swelling w/out tenderdness at inject site;									Y	09/21/1993	09/22/1993	1		PVT	PVT				~ ()~~~In patient	893279012C	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4938120~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0100V~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0064532	04/04/1994	CA	77.0	77		F	10/01/1993	pt recvd vax & devel redness & swelling at inject site;									Y	09/28/1993	09/29/1993	1		PVT	PVT		none;		~ ()~~~In patient	893279013C	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~4938120~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064533	04/04/1994	MI	82.0	82		M		pt recvd vax & devel headache, became quiet & disoriented; episode of incontinence, & began exhibiting unusual behavior; pt taken to hosp & dx w/ encephalopathy; pt was unresponsive & sufferred a cardiac arrest;	Y	11/05/1993	Y		Y	47			N	09/20/1993	09/30/1993	10	spinal tap, bc, nl; mri brain, non diagnostic;	OTH	OTH		chronic low wbcs;		~ ()~~~In patient	893315001J	1						1	Cardiac arrest; Confusional state; Encephalopathy; Headache; Personality disorder; Stupor; Urinary incontinence	FLUX~PFIZER\WYETH~4938141~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0064534	04/04/1994	AR				U	10/14/1993	pt recvd vax & devel erythema;									U					PVT	OTH				~ ()~~~In patient	893300018C	1						1	Rash	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064535	04/04/1994	OH				U	10/04/1993	pt recvd vax & was dx w/ cellulitis characterized by redness & swelling in arm of inject; MD revised dx to local erythematous rxn;									Y				tests were satisfactory;	PVT	OTH				~ ()~~~In patient	893285002J	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4938152~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064536	04/04/1994	WI	51.0	50		F	10/18/1993	pt recvd vax & devel redness, induration & pain at inject site;									U	10/15/1993	10/16/1993	1		PVT	PVT		none;		~ ()~~~In patient	893300011C	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~4938168~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064537	04/04/1994	GA	12.0			U	10/15/1993	pt recvd vax & devel swelling & tight skin at inject site;									U		10/15/1993			PVT	PVT				~ ()~~~In patient	893300012C	1						1	Injection site oedema	FLUX~PFIZER\WYETH~4938181~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064538	04/04/1994	GA				U	10/15/1993	pt recvd vax & devel a welt at inject site									U		10/15/1993			PVT	PVT				~ ()~~~In patient	893300013C	1						1	Injection site hypersensitivity	FLUX~PFIZER\WYETH~4938181~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064539	04/04/1994	GA	4.0			U	10/15/1993	pt recvd vax & devel welt at inject site;									U		10/15/1993			PVT	PVT				~ ()~~~In patient	893300014C	1						1	Injection site hypersensitivity	FLUX~PFIZER\WYETH~4938181~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064540	04/04/1994	ID				U	10/14/1993	pt recvd vax & devel sensitivity to contact lens solutions containing thimerosal;									U					OTH	OTH				~ ()~~~In patient	893300019C	1						1	Unevaluable event	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064541	04/04/1994	PA	42.0	42		F	10/29/1993	pt recvd vax & devel induration 50x38cm, redness, tenderness & warmth at inject site;									Y	10/27/1993	10/28/1993	1		MIL	PVT	none;		pt recv flu vax annually;	~ ()~~~In patient	893308001J	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLUX~PFIZER\WYETH~4938161~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064542	04/04/1994	FL	38.0	38		F	10/14/1993	pt recvd vax & devel laryngitis & achiness; pt had profound weakness;				Y					U	10/04/1993	10/10/1993	6		PVT	OTH			Hashimoto's thyroiditis;	~ ()~~~In patient	893299012C	1						1	Anxiety; Asthenia; Hypertonia; Infection; Laryngitis; Myalgia; Myositis	FLUX~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0064543	04/04/1994	TX	36.0	36		F	10/13/1993	pt recvd vax & started feeling bad & devel low grade fever & sinus problems; pt saw md who dx strep throat; pt devel also headache;				Y					U	10/08/1993	10/09/1993	1		PUB	OTH	brozac			~ ()~~~In patient	893299013C	1						1	Headache; Infection; Malaise; Pyrexia	FLUX~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0064544	04/04/1994	PA	40.0	40		F	10/14/1993	pt recvd vax & devel lymphadenopathy & a fever; pt complained of aching in the deltoid region;									U	10/12/1993	10/14/1993	2	CBC, SMA;	OTH	OTH	none;			~ ()~~~In patient	893299014C	1						1	Lymphadenopathy; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~4938178~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064545	04/04/1994	IN	26.0	26		F	10/13/1993	pt recvd vax & devel local rxn characterized by edema, redness & warmth;									U	10/05/1993	10/06/1993	1		PVT	PVT	Triphasil		Allergic to penicillin;	~ ()~~~In patient	893299015C	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pain; Pruritus	FLUX~PFIZER\WYETH~4938160~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064546	04/04/1994	MA	28.0	28		F	10/15/1993	pt recvd vax & exp pain; became numb & felt tingling down to the hand;									U	10/13/1993	10/13/1993	0		PVT	OTH			Allergic to penicillin;	~ ()~~~In patient	893299016C	1						1	Myalgia; Pain	FLUX~PFIZER\WYETH~4938084~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064547	04/04/1994	PA				U	10/19/1993	pt recvd vax & devel diarrhea next day;									U					PUB	PVT				~ ()~~~In patient	893299018C	1						1	Diarrhoea	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064548	04/04/1994	PA				U	10/19/1993	pt recvd vax & devel diarrhea next day;									U					PUB	PVT				~ ()~~~In patient	893299019C	1						1	Diarrhoea	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064549	04/04/1994	IN				U	10/14/1993	pt recvd vax & devel redness, swelling & warmth in the arm of inject site;									U					OTH	OTH				~ ()~~~In patient	893300004C	1						1	Oedema peripheral; Vasodilatation	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064551	04/04/1994	MN	73.0	73		M	10/15/1993	pt recvd vax & pt white blood count was low (1.2);									Y	10/12/1993	10/14/1993	2	wbc 4300-10800/cu.mm 1200 nl;	PVT	PUB	doxepin; lasix;	acute respiratory infection, cardiac dis	end stage cardiac disease, chronic renal failure, acute respiratory infection;	~ ()~~~In patient	893300017C	1						1	Leukopenia	FLUX~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064552	04/04/1994	HI	52.0	51		M	09/27/1993	pt recvd vax & devel neck stiffness & pain in arm of inject; sx lasted 3 days;									Y	09/21/1993	09/21/1993	0	Lot# 4938137 evauluated & found to be satisfactory;	PUB	PUB	Zyloprim; Capoten	NONE	PCN allergy	~ ()~~~In patient	893300016C	1						1	Nuchal rigidity; Pain	FLUX~PFIZER\WYETH~4938137~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064553	04/04/1994	IN				U	10/14/1993	pt recvd vax & devel redness, swelling & warmth in the arm of inject									U					OTH	OTH	unk	unk	unk	~ ()~~~In patient	893300006C	1						1	Oedema peripheral; Vasodilatation	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064554	04/04/1994	IN				U	10/14/1993	Pt recvd vax & pt devel redness, swelling & warmth in the arm of inject;									U					OTH	OTH	unk	unk		~ ()~~~In patient	893300007C	1						1	Oedema peripheral; Vasodilatation	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064555	04/04/1994	SC	76.0	76		M	10/13/1993	pt recvd vax & pt devel mild flu-like sx;									Y	10/07/1993	10/07/1993	0		PVT	PVT	Amiodarone, Restoril, Klonopin, Captopril, Lasix, Nitrostat, Chronulac, Pilocarpine		allergic to sulfa drugs, coronary artery disease, reflux esophagitis, hx of ventricular arrhythmia	~ ()~~~In patient	893299008C	1						1	Influenza	FLUX~PFIZER\WYETH~4938088~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0064556	04/04/1994	OH				U	10/04/1993	pt recd vax & devel what was dx as cellulitis characterized by redness & swelling in the arm of inject; pt was treated w/ATB & react resolved; on f/u MD dx local erythematous react; felt pt did not have cellulitis									Y				lot# 4938152 was examined & found to be satisfactory	PVT	OTH	unk	prevention	NONE	~ ()~~~In patient	893285004J	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4938152~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064557	04/04/1994	OH				U	10/04/1993	pt recvd vax & devel what was dx as cellulitis characterized by redness & swelling in the arm of inject; pt was treated w/ATB & react resolved; reporter states MD revised dx to local erythematous react-pt did not have cellulitis									Y				lot# 4938152 was examined & found to be satisfactory	PVT	OTH	unk	prevention		~ ()~~~In patient	893285003J	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4938152~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064558	04/04/1994	OH				U	10/04/1993	pt recvd vax & devel what was dx as cellulitis characterized by redness & swelling in the arm of inject; pt was treated w/ATB & the react resolved; on f/u MD dx local erythematous react-felt pt did not have cellulitis									Y				lot# 4938152 was examined & found to be satisfactory	PVT	OTH	unk	prevention		~ ()~~~In patient	893285005J	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4938152~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064559	04/04/1994	IA	58.0	58		F	10/08/1993	Pt recvd vax & devel soreness, swelling, warmth, & redness @ inject site									Y	10/05/1993	10/08/1993	3		PVT	PVT	NONE	NONE		~ ()~~~In patient	893286002J	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLUX~PFIZER\WYETH~4938157~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064560	04/04/1994	IA	37.0	37		F	10/08/1993	pt recvd vax & devel soreness, swelling, warmth, redness, & induration @ the inject site; also exp fatigue									Y	10/05/1993	10/05/1993	0		PVT	PVT	NONE	NONE	pt has lupus	~ ()~~~In patient	893286001J	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Vasodilatation	FLUX~PFIZER\WYETH~4938157~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064561	04/04/1994	FL	41.0	41		F	10/12/1993	pt recvd vax & c/o dry mouth, nausea, & feeling lightheaded, began to shake, BP dec (89/58) & tongue thickened; pt seen in ER & placed on a cardiac monitor & treated w/DPH, SoluMedrol, Tagamet & IV fluids, then discharged				Y					Y	10/12/1993	10/12/1993	0	12OCT93 01710 BP 119/69 pulse 94; 0713 89/58 pulse 78; 0732 111/68, 97; 0830 121/70, 81;	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	893286003J	1						1	Dizziness; Dry mouth; Hypotension; Nausea; Tachycardia; Tongue oedema; Tremor	FLUX~PFIZER\WYETH~4938143~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0064562	04/04/1994	MO	40.0	40		F	10/08/1993	pt recvd vax & devel a generalized fine red body rash & flushing of face, aching & h/a; pt was treated w/APAP & DPH				Y					U	10/05/1993	10/07/1993	2		PUB	PVT	Premarin, flexeril	unk		~ ()~~~In patient	893286005J	1						1	Headache; Myalgia; Rash; Vasodilatation	FLUX~PFIZER\WYETH~4938087~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0064563	04/04/1994	SC	81.0	81		F	10/13/1993	pt recvd vax & devel redness, warmth & itching in the arm of inject; react lasted 1-2 days									Y	09/29/1993	09/29/1993	0		PVT	PVT	Theodur, Ecotrin	NONE	NKA; allergic asthma, aortic regurgitation, esophageal	~ ()~~~In patient	893299006C	1						1	Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~4938088~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064564	04/04/1994	TX	31.0	31		F	10/18/1993	pt recvd vax & c/o aching in the arm, sl tingling in the fingers & arm;  seen by MD 15OCT93 & was treated w/Cortisone inject;				Y					Y	10/12/1993	10/12/1993	0		PUB	PVT	NONE	NONE	pt had GBS @ age 7 due to a vitamin deficiency; episode lasted 9 months;	~ ()~~~In patient	893300010C	1						1	Injection site hypersensitivity; Paraesthesia; Vasodilatation	FLUX~PFIZER\WYETH~4938144~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0064565	04/04/1994	TX	39.0	39		F	10/15/1993	pt recvd vax & devel swelling, redness & pain @ the inject site & was feverish for 5 days									Y	10/06/1993	10/06/1993	0		PUB	OTH	unk	unk	NONE	pt exp same type of adverse event following flu vax~ ()~~~In patient	893300009C	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia	FLUX~PFIZER\WYETH~4938118~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064566	04/04/1994	IN				U	10/14/1993	pt recvd vax devel redness, swelling & warmth in the arm of inject									U					OTH	OTH	unk	unk		~ ()~~~In patient	893300008C	1						1	Injection site hypersensitivity; Vasodilatation	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064567	04/04/1994	SC	72.0	72		F	10/13/1993	pt recvd vax & devel a severe h/a									Y	10/07/1993	10/07/1993	0		PVT	PVT	Synthroid, Tenormin, Pravachol, Lanoxin, Atarax, Advil, vitamin C, Zinc	NONE	No known allergies, supraventricular tachycardia, osteoarthritis, hyperthyroidism, hx of irritable colon, hyperlipidemia	~ ()~~~In patient	893299007C	1						1	Headache	FLUX~PFIZER\WYETH~4938088~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0064568	04/04/1994	SC				U	10/13/1993	pt recvd vax & devel redness, pain & induration in arm of inject				Y					U					PVT	OTH	unk	unk		~ ()~~~In patient	893299003C	1						1	Pain; Skin nodule; Vasodilatation	FLUX~PFIZER\WYETH~4938088~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0064569	04/04/1994	SC	76.0	75		F	10/13/1993	pt recvd vax & devel redness, pain & induration in the arm of inject				Y					Y	10/12/1993	10/13/1993	1		PVT	PVT	Lasix, Klonopin, Pepcid, ditropan, Darvocet, Tenormin, Immodium, K-Dur, Citrocel	unk	pt is allerg to sulfa drugs, Demerol, Mycin drugs	~ ()~~~In patient	893299004C	1						1	Pain; Skin nodule; Vasodilatation	FLUX~PFIZER\WYETH~4938088~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0064570	04/04/1994	WI				F	10/13/1993	pt recvd vax & 1 day later devel redness, pain, swelling & warmth extending from shoulder to elbow; seen by MD who prescribed cold compresses & elevation; sx lasted 5 days									Y	10/11/1993				OTH	PVT	unk	unk		~ ()~~~In patient	893292004J	1						1	Oedema; Pain; Vasodilatation	FLUX~PFIZER\WYETH~4938183~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064571	04/04/1994	OR	45.0			F	10/11/1993	pt recvd vax & felt warm & devel severe diarrhea									U	10/06/1993				OTH	OTH	unk	unk		~ ()~~~In patient	893292005J	1						1	Diarrhoea; Vasodilatation	FLUX~PFIZER\WYETH~4938187~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064572	04/04/1994	SC	55.0	55		F	10/13/1993	pt recvd vax & devel redness & swelling in the arm of inject;									Y	09/01/1993	09/01/1993	0		PVT	PVT	Vasotec, Lasix, Tamoxifen	NONE		~ ()~~~In patient	893299002C	1						1	Oedema peripheral; Vasodilatation	FLUX~PFIZER\WYETH~4938088~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~~1~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0064573	04/04/1994	IL	40.0	40		F	10/01/1993	pt recvd vax & devel a 3-4 inc diameter rash @ the site of inject & on front & back of trunk; this lasted 2 days; On 3rd day larger red raised bumps appeared; these were tender to touch & lasted 10 days; severe h/a & genl malaise;									Y	09/24/1993	09/24/1993	0		OTH	PVT	NONE	NONE	NONE	@ 39 yrs old pt exp joint pain p/flu vax~ ()~~~In patient	893288001J	1						1	Headache; Injection site hypersensitivity; Malaise; Pain; Rash; Rash maculo-papular	FLUX~PFIZER\WYETH~4938142~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064574	04/04/1994	NJ	39.0	39		M	10/08/1993	pt recvd vax & devel oozing of sanguinous fluid, edema, 2.5-3 cm size wheal, area of induration & redness @ the inject site; ice was applied; sx were resolved by 8OCT93									Y	10/07/1993	10/07/1993	0		OTH	OTH	ASA	NONE		~ ()~~~In patient	893286006J	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLUX~PFIZER\WYETH~4938178~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064575	04/04/1994	IL	52.0	52		F	10/01/1993	pt recvd vax & w/in 2 days exp cold sx w/deep cough lasting for 4 wks									Y	09/24/1993	09/26/1993	2		OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient	893288002J	1						1	Cough; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~4938142~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064576	04/04/1994	IL	55.0	55		F	10/01/1993	pt recvd vax & devel rash lasting 2-3 days on the lt arm from wrist to elbow, back of lt leg; pt also exp localized redness, edema, soreness, fever, achiness, rhinorrhea & cough lasted 1 1/2 wks;									Y	09/28/1993	09/28/1993	0		OTH	PVT	NONE	pt felt as if was getting a cold	allergic to PCN, perfumes, cats, insect bites & sun	pt 22 yrs old p/flu vax exp local rash, fever & achiness~ ()~~~In patient	893288003J	1						1	Cough; Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia; Pyrexia; Rash; Rhinitis	FLUX~PFIZER\WYETH~4938142~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064577	04/04/1994	NJ	51.0			F	10/08/1993	pt recvd vax & 3 days later pt devel swelling, warmth, & redness @ the inject site									Y	10/05/1993	10/08/1993	3		PVT	PVT	NONE	NONE	post-lumpectomy	~ ()~~~In patient	893292002J	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0064578	04/04/1994	PA	39.0	39		M	10/11/1993	pt recvd vax & 1 hr later pt devel swelling & pain in the arm of inject which spread up to jaw & face & c/o lt side of face was tight & swollen; dx parotiditis; pt noted lt arm & ax soreness & swelling				Y					N	10/07/1993	10/07/1993	0	Dental x-ray; no abscess	PVT	PVT	Vasotec	NONE	hypertension	NONE~ ()~~~In patient	893292003J	1						1	Face oedema; Myalgia; Oedema; Oedema peripheral; Otitis media; Pain; Sialoadenitis	FLUX~PFIZER\WYETH~4938084~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0056656	04/05/1994	CA	32.0	32		F	10/08/1993	pt recvd vax & devel hives; pt lips & eyelids were swollen & skin turned dark & felt like severe sunburn; pt exp also sweats but no fever;				Y					Y	09/28/1993	09/30/1993	2	none;	PVT	OTH	methotrexate inject 1x / wk; imuran daily, po	sinus infection - acute	psoriatic arthritis - chronic	~ ()~~~In patient	893284008J	1						2	Face oedema; Hyperhidrosis; Rash; Skin discolouration; Urticaria	FLUX~PFIZER\WYETH~4938122~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0064514	04/05/1994	FL	38.0	38		M	10/07/1993	pt recvd vax & devel severe aches, stomach cramps, testicular pain, diarrhea & vomiting; pt also exp shivering & a headache; tx w/ advil & fluids; pt devel epidymal orchitis; pt dx w/ toxic viral syndrome & epididymitis;				Y					Y	09/27/1993	09/29/1993	2	cat scan of head neg; spinal tap neg;	OTH	OTH		none;		~ ()~~~In patient	893281004J	1						1	Abdominal pain; Diarrhoea; Epididymitis; Headache; Infection; Myalgia; Orchitis; Vomiting	FLUX~PFIZER\WYETH~4938149~3~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0061010	04/07/1994	NY	33.0			F	02/28/1994	Pt recvd vax & exp a stroke approx 8 days p/vax; fully recovered; MD has reportedly informed consumer that pt has a congenital weakness in carotid artery;			Y						Y				NA	OTH	OTH	NA		congenital weakness carotid artery;	NA~ ()~~~In patient	940044001	1						2	Cerebrovascular accident; Condition aggravated; Cerebrovascular accident	FLU3~CONNAUGHT LABORATORIES~~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~PFIZER\WYETH~~1~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~2	USA	Life Threatening	Influenza
0061685	04/08/1994	TX	49.0			M		pt recvd flu vax & devel non-serious self-limiting pericarditis & was adm to hosp;					Y					10/04/1993	10/04/1993	0		UNK	UNK				~ ()~~~In patient		1						1	Pericarditis	FLUX~PFIZER\WYETH~3J41146~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0059129	04/12/1994	CA	62.0	62		M	11/24/1992	18NOV devel ha/ & general malaise w/sl elevated temp;									U	11/10/1992	11/18/1992	8		PUB	UNK		NONE	NONE	~ ()~~~In patient	CA94051	1						2	Headache; Malaise; Pyrexia; Headache; Malaise; Pyrexia	FLUX~PFIZER\WYETH~4928219~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928219~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0059132	04/12/1994	CA	80.0	79		F	11/02/1992	redness, swelling the size of inject;									Y	10/29/1992	10/29/1992	0		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	CA94038	1						2	Injection site hypersensitivity; Injection site oedema; Injection site hypersensitivity; Injection site oedema	FLUX~PFIZER\WYETH~4928219~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4928219~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0061754	04/12/1994	CA	59.0	59		F	02/09/1994	h/a, rash lower legs & waist a day p/flu P\& pneumonia shot x 1 wk; no treatment needed;									Y	01/20/1993	11/22/1993	306	NONE	PUB	PUB	Premarin, Dyaside	NONE	NONE	~ ()~~~In patient	CA94052	1						1	Headache; Rash	FLUX~PFIZER\WYETH~493814268~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~330948~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0061755	04/12/1994	CA	77.0	77		F	01/18/1994	flu sx also wheezing & a feeling of lungs full of water, persisted till the end of December; no MD seeing feels fine now; advised to se MD a/next flu shot;									Y	10/07/1993	10/08/1993	1		PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	CA94053	1						1	Asthma; Influenza; Lung disorder	FLUX~PFIZER\WYETH~4938142~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0061772	04/12/1994	FL	68.0			M	01/03/1994	following flu vax & pneumonia devel resp failure; lung biopsy-usual interstital pneumonitis; died 18DEC93;	Y	12/18/1993											Chest XR; lung biopsy;	UNK	UNK	Lasix, Coumaden, Potassium, Lanoxin;		hx heart disease-MI 1SEP93; OCT93 congestive heart failure; SEP93 bypass surgery;			1						1	Apnoea; Pneumonia	FLUX~PFIZER\WYETH~4938088~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~324906~UNK~~~PNEUMO (PNU-IMUNE)~1	USA	Results in Death	Influenza
0061773	04/12/1994	FL	56.0			M	11/22/1993	sx of weakness in both feet w/inability to stand; pt progressed to resp distress & required intubation;			Y		Y					11/12/1993	11/18/1993	6	Myelogram neg;	UNK	UNK				~ ()~~~In patient		1						1	Dyspnoea; Myasthenic syndrome; Respiratory disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0061777	04/12/1994	CA	71.0	71		M	01/19/1994	fever 100.2, chills, congestion, weak x 1 wk p/flu shots, was given ATB by MD due to bronchitis not flu react;				Y					Y	10/01/1993	10/01/1993	0	NONE	PVT	UNK	Alupirunil		gout	NONE~ ()~~~In patient		1						1	Asthenia; Bronchitis; Chills; Pyrexia; Rhinitis	FLUX~PFIZER\WYETH~493814268~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0048815	04/18/1994	OR	33.0	33		F	11/23/1992	17NOV92 had night sweats-woke up w/sore neck & 1/2 nodule;  sharp pain in lt neck area, numbness lt neck, face & lt arm; went to ER for help;  20NOV 3 more nodules appeares on lt lymph area @ neck; no fever; dec weakness & h/a;				Y					U	11/12/1992	11/17/1992	5		PUB	PUB	BCP	NONE	hayfever in summer; no allergy to mes;	NONE~ ()~~~In patient	OR9268	1						2	Asthenia; Headache; Hyperhidrosis; Lymphadenopathy; Neck pain; Paraesthesia; Skin nodule	FLUX~PFIZER\WYETH~4928231~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0061810	04/18/1994	ID	57.0	57		F	03/22/1994	pain @ site of inject which progressed to shoulders & cervical spine; This porgression occurred in 2-3 dasy time & has been ongoing; antiinflammatory meds have been used w/o much benefit; ROM is limited;				Y					N	11/19/1993	11/19/1993	0		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	ID94021	1						1	Hypokinesia; Injection site pain; Neck pain; Pain	FLU3~CONNAUGHT LABORATORIES~3F41122~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0061821	04/18/1994	NC	76.0	76		F	02/03/1994	raw, red moist sore @ vax site; 3mo persistent intermittently raw, red & moist, raised; would devel gray, thin membrane, which would be removed by pt's application of alcohol									N	11/04/1993	11/07/1993	3	NONE	PUB	PUB	ASA, Vitamin E, Multivitamins, B Carotine;	NONE	allergic-laryngitis, hives due to mites?	NONE~ ()~~~In patient	NC94040	1						1	Injection site abscess; Injection site hypersensitivity; Injection site mass; Injection site reaction	FLUX~PFIZER\WYETH~4938182~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~LEDERLE LABORATORIES~348910~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0061918	04/18/1994	CA	40.0			F	03/07/1994	fever; erythema nodosum; recvd flu vax twice previously w/o adverse effects;									Y	10/26/1993	11/02/1993	7		PVT	PVT	NONE	NONE		NONE~ ()~~~In patient		1						1	Erythema nodosum; Pyrexia	FLUX~PFIZER\WYETH~4938142~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0041964	04/25/1994	CA				M	01/03/1994	pt recvd vax & devel Guillain barre synd; pt hosp twice & continue to exp lower leg problems, weakness & loss of stamina; report previously reported to FDA;			Y		Y			Y	N		11/06/1991			PUB	PUB				~ ()~~~In patient	894005001J	1						3	Asthenia; Guillain-Barre syndrome; Asthenia; Guillain-Barre syndrome	FLUX~PFIZER\WYETH~4918169~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~PFIZER\WYETH~285909~UNK~~~PNEUMO (PNU-IMUNE)~2|FLUX~PFIZER\WYETH~4918169~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|PPV~PFIZER\WYETH~285909~UNK~~~PNEUMO (PNU-IMUNE)~3	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0059968	04/25/1994	AR	5.0	5		M	11/04/1993	pt returned to clinic the following day w/quarter sized raised bumps on back; MD felt pt had an adverse react to influenza vax;				Y					Y	10/26/1993	10/27/1993	1	NONE	PUB	PUB	NONE	NA	NA	~ ()~~~In patient	AR9420	1						2	Skin nodule; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~3F41032~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~3F41032~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0062092	04/25/1994	OR	75.0			M	04/12/1994	pt adm due to dizziness & inc phenytoin level; had flu vax about 3 wks prior to admit; could have contributed to increased phenytoin level; no other recent changes in drug therapy;					Y					10/14/1993	11/04/1993	21	Phenytoin lever 13.4 24AUG94; Phenytoin Level 4NOV93 20.5; Albumin 2.9; true Phenytoin level (corrected for low albumin) 29.5;	UNK	UNK	Isorsorbide, Coumadin, Roxauol, Furosemide, Zestril, Hazodone, KCL;		seizure disorder, CHF, COPD, CAD, hx of MI, CVA, DVT, PUD	~ ()~~~In patient		1						1	Dizziness; Drug interaction; Hypoproteinaemia; Laboratory test abnormal	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0060003	04/29/1994	TX	22.0	22		M	04/25/1994	Pt was hospitalized w/GBS; became ill 1st of DEC 1993;			Y	Y	Y	43	Y	Y	N	11/23/1993	12/15/1993	22		PUB	PVT	None	None	None	None~ ()~~~In patient		1						2	Guillain-Barre syndrome; Neuropathy; Guillain-Barre syndrome; Back pain; Myasthenic syndrome; Neck pain; Neuropathy	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~3F41124~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~3F41124~1~~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0066641	04/30/1994	PA	75.0	75		F	09/29/1993	1 hr p/vax pt devel an inject site react, 7 x 4 pnu-immune site); site was indurated, red, painful; pt was started on DPH, ice packs & steroid ointments; p/24 hrs the inject site was still indurated;				Y					N	09/28/1993	09/28/1993	0	NA	PVT	PVT	NONE	NONE	NONE	NA~ ()~~~In patient	930213101	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~PARKE-DAVIS~~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~326921~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0062209	05/02/1994	WA				F	04/11/1994	This eight-month gestational age fetus, whose mom was given flu vax in OCT93, died due to viremia in DEC93 coincident w/the mother developing a severe influenza infection;				Y						10/01/1993	12/01/1993	61	Examination of placenta revealed white cell (lymphocytic) infiltration, but no bacteria could be cultured;	PVT	PVT	unk	NONE		~ ()~~~In patient	894103003A	1						1	Drug ineffective; Foetal disorder; Infection; Influenza; Stillbirth; Drug ineffective; Infection; Influenza; Stillbirth; Uterine rupture	FLUX~PFIZER\WYETH~4938137~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938137~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0062422	05/03/1994	MI	62.0	62		F	04/29/1994	began having periodic flu like dx 3 days p/vax & cont on & off until pt died; from viral endocarditis;	Y	03/24/1994							N	10/05/1993	10/08/1993	3		PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Endocarditis; Infection; Influenza	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0062479	05/05/1994	TX	47.0	47		F	04/26/1994	almost immed started having deep throbbing pain @ site of inject; cont almost daily thru present time;									N	11/12/1993	11/12/1993	0	NONE	PVT	PVT	Estraderm, Provera	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site pain	FLU3~PARKE-DAVIS~00963P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0058060	05/06/1994	MD	31.0	31		F	01/13/1994	pt recvvd vax & could not see things on rt side; devel headache, sinus cold; pt dx w/ optic neuritis & vision was blury;				Y					N	10/20/1993	10/24/1993	4		PVT	PVT	phenobarbital	epilepsy	pt has epilepsy	~ ()~~~In patient	894033004J	1						2	Headache; Optic neuritis; Pharyngitis; Rhinitis; Visual disturbance	FLUX~PFIZER\WYETH~4938182~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0058194	05/06/1994	CA	23.0	23		M	01/19/1994	pt recvd vax & was lightheaded & weak; HR was 60bpm; tx w/ ammonia;									Y	10/12/1992	10/12/1993	365	HR 60, 76, 84; BP 120/80, 140/94;	OTH	OTH	none;			~ ()~~~In patient	894053015J	1						2	Asthenia; Dizziness	FLUX~PFIZER\WYETH~4938158~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058195	05/06/1994	CA	59.0	59		F	01/19/1994	pt recvd vax & exp faintness, warmth, & nausea;									Y	10/21/1993	10/21/1993	0		OTH	PVT				~ ()~~~In patient	894081005A	1						2	Dizziness; Nausea; Vasodilatation	FLUX~PFIZER\WYETH~4938158~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058196	05/06/1994	CA	51.0	51		F	01/19/1994	pt recvd vax & devel sweats, coughing, chest discomfort, & sneezing;									Y	10/08/1993	10/14/1993	6		OTH	PVT				~ ()~~~In patient	894082007A	1						2	Chest pain; Cough; Hyperhidrosis; Rhinitis	FLUX~PFIZER\WYETH~4938158~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058197	05/06/1994	CA	41.0	41		F	01/19/1994	pt recvd vax & exp tingling in fingertips;									Y	10/18/1993	10/18/1993	0		OTH	PVT			anxiety attacks;	~ ()~~~In patient	894053018J	1						2	Paraesthesia	FLUX~PFIZER\WYETH~4938158~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058198	05/06/1994	CA	46.0	46		F	01/19/1994	pt recvd vax & exp n,v, diarrhea, headache & body aches;									Y	10/14/1993	10/15/1993	1		OTH	PVT	privil	none;	none;	~ ()~~~In patient	894053019J	1						3	Diarrhoea; Headache; Myalgia; Nausea; Vomiting	FLUX~PFIZER\WYETH~4938158~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA		Influenza
0058199	05/06/1994	CA				M	10/27/1993	pt recvd vax & exp a feeling of tightness in head;									Y	10/27/1993	10/27/1993	0		OTH	PVT				~ ()~~~In patient	894053021J	1						2	Headache	FLUX~PFIZER\WYETH~4938158~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058200	05/06/1994	CA	27.0	27		M	01/19/1994	pt recvd vax & exp cramping, headache, & achiness;									Y	11/06/1993	11/09/1993	3		OTH	PVT				~ ()~~~In patient	894082008A	1						2	Abdominal pain; Headache; Myalgia	FLUX~PFIZER\WYETH~4938158~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058201	05/06/1994	CA	26.0	26		F	01/19/1994	pt recvd vax & devel flu symptoms w/ cough & congestion;									Y	11/11/1993	11/22/1993	11		OTH	OTH	insulin		pt has diabetes	~ ()~~~In patient	894053023J	1						2	Cough; Influenza; Rhinitis	FLUX~PFIZER\WYETH~4938192~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058202	05/06/1994	CA	39.0	39		F	01/01/1994	pt recvd vax & exp dizziness, faintness, hyperventilation & anxiety;									Y	11/16/1993	11/16/1993	0		OTH	PVT	retin a; ativan;			~ ()~~~In patient	894053022J	1						2	Anxiety; Dizziness; Hyperventilation	FLUX~PFIZER\WYETH~4938158~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058203	05/06/1994	CA	50.0	49		F	01/19/1994	pt recvd vax & devel raised (1/4 inch elevation) & red area (1 1/2 inch) at inject site;									Y	10/13/1993	10/13/1993	0		OTH	PVT	thyroid	none;	allergy to gantrisan & sulfa drugs;	~ ()~~~In patient	894053014J	1						2	Injection site hypersensitivity; Injection site mass; Nausea; Pruritus; Pyrexia	FLUX~PFIZER\WYETH~4938158~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058204	05/06/1994	CA	33.0	32		M	01/19/1994	pt recvd vax & exp dizziness, felt feverish, stiffness & soreness of lt arm; 2 hrs after vax, small pin sized reddish bumps devel, accompanied w/ pruritus & some blotchiness;									Y	09/30/1993	09/30/1993	0		OTH	PVT		none		~ ()~~~In patient	894053020J	1						2	Dizziness; Hypertonia; Myalgia; Pruritus; Pyrexia; Rash maculo-papular	FLUX~PFIZER\WYETH~4938158~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058206	05/06/1994	CA	32.0	32		M	01/19/1994	pt recvd vax & felt ill, as if he had flu; felt tired & had chills;									Y	11/17/1993	11/17/1993	0		OTH	PVT		none;		~ ()~~~In patient	894082009A	1						2	Asthenia; Chills; Influenza; Malaise	FLUX~PFIZER\WYETH~4938158~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058207	05/06/1994	CA	55.0	55		F	01/19/1994	pt recvd vax & devel sore throat, abdo cramps & shortness of breath;									Y	11/03/1993	11/03/1993	0		OTH	PVT		none;		~ ()~~~In patient	894082010A	1						2	Abdominal pain; Dyspnoea; Pharyngitis	FLUX~PFIZER\WYETH~4938158~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058208	05/06/1994	CA	57.0	57		F	01/19/1994	pt recvd vax & exp warmth & pain at inject site;  pt exp swelling (3 inches diam, 1/4 inches elevation) & redness at inject site; also soreness continued in the left arm muscle;									Y	11/04/1993	11/04/1993	0		OTH	OTH	premarin	none;		~ ()~~~In patient	894081001A	1						2	Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia; Vasodilatation	FLUX~PFIZER\WYETH~4938158~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058209	05/06/1994	CA	32.0	32		M	01/19/1994	pt recvd vax & devel hives on face, upper left cheekbone, & upper left arm;									Y	11/09/1993	11/10/1993	1		OTH	OTH	grisactin	none;		~ ()~~~In patient	894081006A	1						2	Urticaria	FLUX~PFIZER\WYETH~4938158~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058210	05/06/1994	CA	27.0	27		M	01/19/1994	pt recvd vax & devel slight swelling & redness of left arm; pt noted some tingling;									Y	11/16/1993	11/16/1993	0		OTH	PVT				~ ()~~~In patient	894082011A	1						2	Injection site hypersensitivity; Injection site oedema; Paraesthesia	FLUX~PFIZER\WYETH~4938158~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058211	05/06/1994	CA	33.0	33		M	01/19/1994	pt recvd vax & became pale & lightheaded;									Y	11/16/1993	11/16/1993	0		OTH	PVT				~ ()~~~In patient	894082013A	1						2	Dizziness; Pallor	FLUX~PFIZER\WYETH~4938192~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058213	05/06/1994	CA	16.0	16		M	01/19/1994	pt recvd vax & passed out for 5-10 sec; bp was 98/68 mmhg, pulse 68; pt had headache;									Y	10/29/1993	10/29/1993	0	vital signs times 1545 1600 1615; bp 98/68, 90/64, 108/68; pulse 68 64 72;	PUB	PVT		none;		~ ()~~~In patient	894082006A	1						2	Headache; Hypotension; Syncope	FLUX~PFIZER\WYETH~4938158~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058214	05/06/1994	CA	45.0	45		F	01/19/1994	pt recvd vax & complained of lighthededness & feeling warm;									Y	10/21/1993	10/21/1993	0		OTH	PVT				~ ()~~~In patient	894081003A	1						2	Dizziness; Vasodilatation	FLUX~PFIZER\WYETH~4938158~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058215	05/06/1994	CA				F	01/19/1994	pt recvd vax & devel red spot & soreness at inject site; flu like symptoms w/ fever, t 102; blured vision & dizziness;									U	10/22/1993	10/23/1993	1		OTH	PVT		stevens johnson synd		~ ()~~~In patient	894081004A	1						2	Amblyopia; Dizziness; Influenza; Injection site hypersensitivity; Injection site pain; Pyrexia	FLUX~PFIZER\WYETH~4938158~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058216	05/06/1994	CA	56.0	56		F	01/19/1994	pt recvd vax & devel redness & swelling of arm from shoulder to elbow;									Y	10/16/1993	10/16/1993	0		OTH	PVT				~ ()~~~In patient	894081002A	1						2	Oedema peripheral; Vasodilatation	FLUX~PFIZER\WYETH~4938158~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058217	05/06/1994	CA	49.0	49		M	01/19/1994	pt recvd vax & exp dizziness									Y	10/21/1993	10/21/1993	0		OTH	PVT				~ ()~~~In patient	894082005A	1						2	Dizziness	FLUX~PFIZER\WYETH~4938158~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058218	05/06/1994	CA	25.0	25		F	01/19/1994	pt recvd vax & exp dizzziness & sweating; BP was 76/54 mmhg, pulse 100, t 97.4; pt complained of headache;									Y	10/29/1993	10/29/1993	0	vital signs times 1740 1755 1810; BP 76/54 94/64 88/68; pulse (bpm) 100, 76; t 97.4;	PUB	PVT	none;	none		~ ()~~~In patient	894082004A	1						2	Dizziness; Headache; Hyperhidrosis; Hypotension; Tachycardia	FLUX~PFIZER\WYETH~4938158~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058219	05/06/1994	CA				M	01/19/1994	pt recvd vax & felt hot & feverish, slightly clammy & was pale;									Y		10/26/1993			OTH	PVT				~ ()~~~In patient	894082015A	1						2	Hyperhidrosis; Pallor; Pyrexia; Vasodilatation	FLUX~PFIZER\WYETH~4938192~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058220	05/06/1994	CA	37.0	37		F	01/19/1994	pt recvd vax & exp heaviness in arm;									Y	10/26/1993	10/26/1993	0		OTH	PVT	none	none;	allergic to pcn, sulfa, lincocin, & anesthetics	~ ()~~~In patient	894082003A	1						2	Myasthenic syndrome	FLUX~PFIZER\WYETH~4938158~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058221	05/06/1994	CA	43.0	43		F	01/19/1994	pt recvd vax & exp soreness of arm & lethargy; inject site was raised 1/4 inch & hard over a 3 to 4 inch area ;									Y	10/16/1993	10/16/1993	0		OTH	PVT	thyroid medication	none;		~ ()~~~In patient	894082002A	1						2	Injection site mass; Myalgia; Somnolence	FLUX~PFIZER\WYETH~4938158~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058222	05/06/1994	CA	40.0	40		F	01/19/1994	pt recvd vax & devel fever, sore throat, & sluggishness; pt exp sweating 1 day later;									U	10/21/1993	10/22/1993	1		OTH	OTH	none	none		~ ()~~~In patient	894082001A	1						2	Hyperhidrosis; Hypokinesia; Pharyngitis; Pyrexia	FLUX~PFIZER\WYETH~4938158~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0058224	05/06/1994	CA	53.0	53		F	01/19/1994	pt recvd vax & exp anxiety attack consisting of tightneess in chest, stomach upset & nervousness;									Y	10/08/1993	10/08/1993	0		OTH	PVT	vitamins	none;	none;	~ ()~~~In patient	894082012A	1						2	Anxiety; Chest pain; Dyspepsia; Nervousness	FLUX~PFIZER\WYETH~4938158~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0059279	05/06/1994	TX	31.0	30		F	01/20/1994	pt recvd vax & discomfort at inject site & devel small, slightly palpable nodule;				Y					Y	10/13/1993	10/15/1993	2		PVT	PVT		none;	pt had hepatitis at 8y;	~ ()~~~In patient	894053008J	1						2	Injection site mass; Injection site pain; Injection site mass; Injection site pain	FLUX~PFIZER\WYETH~4938144~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938144~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0065010	05/06/1994	UT	43.0			F	02/25/1994	pt recvd vax & devel urticaria; tx w/ hydroxyzine, iv solu medrol, & hydrocortisone topical ointment;					Y				Y					OTH	OTH			pt had hives while taking zantac & vitamins;	~ ()~~~In patient	894074001A	1						1	Urticaria	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0065011	05/06/1994	PA	34.0	34		F	01/10/1994	pt recvd vax & devel redness & pain at inject site; nausea, dizziness, difficulty concentrating, fatigue, hypertension & dec appetite & 20 pound weight loss; MD dx as depression & prescribed prozac;				Y					U	10/25/1993	11/12/1993	18		OTH	OTH				~ ()~~~In patient	894033001J	1						1	Asthenia; Depression; Dizziness; Hypertension; Injection site hypersensitivity; Injection site pain; Thinking abnormal; Weight decreased	FLUX~PFIZER\WYETH~~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0065012	05/06/1994	CA	52.0	51		F	01/13/1994	pt recvd vax & devel myalgia, sinusitis & upper respiratory infect, coughing up green stuff; pt interpreted these symptoms as lack of effect; pt dx w/ allergies versus prolonged viral infection;									N	11/19/1993	01/08/1994	50	throat/sputum cultures neg;	PVT	PVT	premarin	none;		~ ()~~~In patient	894033002J	1						1	Cough; Drug ineffective; Hypersensitivity; Infection; Laryngitis; Myalgia; Pharyngitis; Sinusitis	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0065013	05/06/1994	NJ	58.0	58		F	01/12/1994	pt recvd vax & devel a corneal erosion;									Y	10/06/1993	10/11/1993	5		OTH	OTH	hydrochlorathiazide; ultra humulin insulin;		pt has diabetes & hx of corneal erosions;	pt devel corneal erosion following last year's flu vax;~ ()~~~In patient	894033003J	1						1	Condition aggravated	FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0065015	05/06/1994	WA				U	01/11/1994	pt recvd vax & devel thrombotic thrombocytopenic purpura;									U					OTH	OTH				~ ()~~~In patient	894053001J	1						1	Thrombotic thrombocytopenic purpura	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0065016	05/06/1994	WA				U	01/11/1994	pt recvd vax & develthrombotic thrombocytopenic purpura;									U					OTH	OTH				~ ()~~~In patient	894053002J	1						1	Thrombotic thrombocytopenic purpura	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0065017	05/06/1994	WA				U	01/11/1994	pt recvd vax & devel thrombotic thrombocytopenic purpura;									U					OTH	OTH				~ ()~~~In patient	894053003J	1						1	Thrombotic thrombocytopenic purpura	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0065018	05/06/1994	WA				U	01/11/1994	pt recvd vax & devel throbotic thrombocytopenic purpura									U					OTH	OTH				~ ()~~~In patient	894053004J	1						1	Thrombotic thrombocytopenic purpura	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0065019	05/06/1994	WA				U	01/11/1994	pt recvd vax & devel thrombotic thrombocytopenia purpura;									U					OTH	OTH				~ ()~~~In patient	894053005J	1						1	Thrombotic thrombocytopenic purpura	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0065020	05/06/1994	WA				U	01/11/1994	pt recvd vax & devel thrombotic thrombocytopenic purpura									U					OTH	OTH				~ ()~~~In patient	894053006J	1						1	Thrombotic thrombocytopenic purpura	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0065021	05/06/1994	CO	31.0			F	01/24/1994	pt recvd vax & noted white, circular ring like area of hypopigmentation at inject site;									N	09/19/1993	10/01/1993	12		PUB	OTH				~ ()~~~In patient	894053007J	1						1	Skin disorder	FLUX~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0065023	05/06/1994	CA				U	01/14/1994	pt recvd vax & devel overt influenza symptoms;									U					OTH	OTH				~ ()~~~In patient	894053009J	1						1	Drug ineffective; Infection; Influenza	FLUX~PFIZER\WYETH~4938137~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0065024	05/06/1994	IL	41.0	41		M	01/31/1994	pt recvd vax & had occasional tenderness at inject site w/ pain & stiffness of left shoulder; pt dx w/ myositis secondary to the vax which was felt to be a delayed hypersensitivity;				Y					N	10/21/1993	10/21/1993	0	x rays of lt shoulder nl;	OTH	OTH				~ ()~~~In patient	894053010J	1						1	Hypertonia; Injection site hypersensitivity; Injection site pain; Myositis; Pain	FLUX~PFIZER\WYETH~4938160~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0065025	05/06/1994	IL	44.0	44		F	01/31/1994	pt recvd vax & exp tenderness at inject site & pain									N	11/18/1993	11/18/1993	0		OTH	OTH				~ ()~~~In patient	894053011J	1						1	Injection site pain; Pain	FLUX~PFIZER\WYETH~4938116~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0065026	05/06/1994	CA				M	01/14/1994	pt recvd vax & devel overt flu lke symptoms including fever, achiness, & dry cough; lack of vax effectiveness;									Y	09/21/1993	12/12/1993	82		PVT	OTH				~ ()~~~In patient	894053012J	1						1	Cough; Drug ineffective; Infection; Influenza; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~4938137~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0065027	05/06/1994	CA				U	01/14/1994	pt recvd vax & devel overt flu like symptoms including fever, achiness, dry cough; reporter suspected lack of vax effectiveness;									U					PVT	OTH				~ ()~~~In patient	894053013J	1						1	Cough; Drug ineffective; Infection; Influenza; Myalgia; Pyrexia	FLUX~PFIZER\WYETH~4938137~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0065030	05/06/1994	CA	46.0	46		M	01/19/1994	pt recvd vax & exp chills & sweats; dizziness, nausea, stomach cramps, diarrhea & cough;									Y	10/08/1993	10/08/1993	0		OTH	PVT		none;	hx of hayfever	none;~ ()~~~In patient	894053016J	1						1	Abdominal pain; Chills; Cough; Diarrhoea; Dizziness; Hyperhidrosis; Nausea	FLUX~PFIZER\WYETH~4938158~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0065031	05/06/1994	CA				F	01/19/1994	pt recvd vax & exp lightheadedness, dizziness, & clamminess;									Y	10/30/1993	10/30/1993	0		OTH	PVT	none;	none;		~ ()~~~In patient	894053017J	1						1	Dizziness; Hyperhidrosis	FLUX~PFIZER\WYETH~4938158~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0065038	05/06/1994	MO	57.0	57		M	01/24/1994	pt recvd vax & devel lump (4-5) at inject site; biopsy revealed mild dermal fibrosis;				Y					Y	10/01/1993	10/01/1993	0	bioopsy mild dermal fibrosis;	PUB	OTH			none	~ ()~~~In patient	894053024J	1						1	Injection site fibrosis; Injection site mass	FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0065039	05/06/1994	ME	65.0			M	01/27/1994	pt recvd vax & contracted the flu;									U					OTH	OTH				pt exp fly synd w/ flu vax;~ ()~~~In patient	894053025J	1						1	Drug ineffective; Infection; Influenza	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0065040	05/06/1994	ME	65.0			F	01/27/1994	pt recvd vax & contracted the flu;									U					OTH	OTH				pt exp flu synd w/ vax previous year;~ ()~~~In patient	894053026J	1						1	Drug ineffective; Infection; Influenza	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0065041	05/06/1994	ME	65.0			F	01/27/1994	pt recvd vax & contracted the flu;									U					OTH	OTH				pt exp flu sx @ 64 y/o p/flu vax #unk;~ ()~~~In patient	894053027J	1						1	Drug ineffective; Infection; Influenza	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0065042	05/06/1994	WY	51.0	51		F	02/01/1994	pt recvd vax & exp shoulder pain which has persisted to date;				Y					N	11/01/1993	11/08/1993	7	bone scan - hot flow stage	PUB	OTH	prednisone		arthritis & lupus erthematosis treated w/steroids;	~ ()~~~In patient	894066003A	1						1	Laboratory test abnormal; Osteonecrosis; Pain	FLUX~PFIZER\WYETH~4938180~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0065043	05/06/1994	DE				M	02/22/1994	pt recvd vax & exp hives;									Y	10/01/1993	10/01/1993	0		OTH	OTH	vitamin c, vitamin a;	none	approx 2 wks prior to vax, pt tx w/ erythromicin for pneumonia due to mycoplasma; pt has low ige antibody against latex; serum testing for egg white & egg yolk were neg hx of eagle-barrett synd w/ bladder extrophy corrected in infancy;	none~ ()~~~In patient	894074002A	1						1	Urticaria	FLUX~PFIZER\WYETH~4938193~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0065044	05/06/1994	CA	60.0	60		F	02/15/1994	pt recvd vax & was dx w/ viral influenza; symptoms included achiness esp in neck, arms, & shoulders; f of 100.6 & cough; tx w/ zithromax, ampicillin, & robitussin DM;				Y					N	09/01/1993	01/01/1994	122		PVT	PVT	combipres	none;	hx of hypertension	~ ()~~~In patient	894074003A	1						1	Cough; Drug ineffective; Infection; Influenza; Myalgia; Neck pain; Pyrexia	FLUX~PFIZER\WYETH~~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0065045	05/06/1994	CA				M	02/15/1994	pt recvd vax & contracted the flu									U					PVT	PVT				~ ()~~~In patient	894074004A	1						1	Drug ineffective; Infection; Influenza	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0065065	05/06/1994	CA				M	01/19/1994	pt recvd vax & devel lightheadedness;									Y	10/16/1993	10/16/1993	0		OTH	PVT				~ ()~~~In patient	894082014A	1						1	Dizziness	FLUX~PFIZER\WYETH~4938192~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0065067	05/06/1994	OH	45.0			M	03/21/1994	pt recvd vax & devel hives, angioedema & a fever;				Y					Y	10/01/1993	10/01/1993	0		PUB	OTH	none;	none;	pt has hx of heart disease; pt had similar rxn when recv flugen	pt exp similar rxn w/flu vax 92-93 formula;~ ()~~~In patient	894087003A	1						1	Angioneurotic oedema; Pyrexia; Urticaria	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0065068	05/06/1994	WI				F	02/28/1994	pt recvd vax & devel redness & pruritus at inject site;									Y	10/18/1993	10/19/1993	1		PVT	PVT	none;	none;		~ ()~~~In patient	894089001A	1						1	Injection site hypersensitivity; Pruritus	FLUX~PFIZER\WYETH~4938168~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0065069	05/06/1994	CA	40.0	39		F	03/29/1994	pt recvd vax & devel redness & swelling at inject site; pt had fever & chills & also had pain in arm which extends to the neck, chest & back;				Y					N	11/05/1993	11/07/1993	2		OTH	PVT		none;		~ ()~~~In patient	894090002A	1						1	Back pain; Chest pain; Chills; Injection site hypersensitivity; Injection site oedema; Neck pain; Pain; Pyrexia	FLUX~PFIZER\WYETH~4938193~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0065070	05/06/1994	MN	43.0	43		F	01/21/1994	pt recvd vax & exp achiness, fatigue, headache, nausea, vomiting; t 99.7;									Y	11/01/1993	11/04/1993	3		PUB	PUB	none;	none;		~ ()~~~In patient	894096006A	1						1	Asthenia; Headache; Myalgia; Nausea; Pyrexia; Vomiting	FLUX~PFIZER\WYETH~4938192~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0062502	05/09/1994	WV	61.0	61		F	04/25/1994	17MAR94 pt phoned c/o knot in lt arm site of flu shot 1OCT93; states had itching & reddness @ inject site for 2 days p/inject but subsided; was seen 18APR94: imp 1) r/o erythema nodosum ? etiology; 2) r/o arthus rxn;									U	10/01/1993	03/17/1994	167		PUB	PUB		NONE	NONE	~ ()~~~In patient	WV9414	1						1	Erythema nodosum; Injection site hypersensitivity; Injection site mass; Pruritus; Serum sickness	FLU3~CONNAUGHT LABORATORIES~3F41008~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0058870	05/13/1994	MA	18.0	18		M	12/28/1993	bells palsy;loss of reflex, loss of muscle tone on legs then arms resulting in paralysis; loss of vision due to weakness of optical lens muscle dx w/GBS; required rehab;					Y	30			N	11/14/1993	11/25/1993	11	LP, MRI, Electromoygraphy, lyme disease (neg) neuro neg;	PVT	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						2	Amblyopia; Facial palsy; Guillain-Barre syndrome; Headache; Hyporeflexia; Myasthenic syndrome; Paralysis; Blindness; Facial palsy; Guillain-Barre syndrome; Hyporeflexia; Hypotonia; Myasthenic syndrome; Paralysis	FLUX~PFIZER\WYETH~4938160~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938160~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0062765	05/13/1994	NY	66.0			F	05/09/1994	Guillain-Barre synd;										10/01/1993	10/16/1993	15	EMG; CSF; Clinical;	UNK	UNK			no prior reactions to flu vax;	~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0062792	05/16/1994	CA	56.0	56		F	02/20/1994	during the 2nd wk of DEC 11DEC92 pt had high fever 104 & severe weakness for 4-5 days; about 20DEC92 noted difficulty in getting dressed; 24DEC92 difficulty in speaking w/paralysis on lt side of face; dx Bell's palsy; placed of Pred;			Y	Y					Y	11/20/1992	12/20/1992	30	neurological test & LP DEC92;	PVT	PUB		NONE		~ ()~~~In patient		1						1	Back pain; Facial palsy; Gait disturbance; Guillain-Barre syndrome; Hypokinesia; Myasthenic syndrome; Pyrexia; Speech disorder	FLUX~PFIZER\WYETH~4928229~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0062989	05/19/1994	SD	29.0	29		F	05/02/1994	pt recvd vax & reported intense pain in area from shot rt deltoid starting @ about 330PM felt fine; some warmth to face; dizziness, ceiling spinning, did not become unconscious, face & arms became numb;					Y	1			Y	09/29/1993	09/29/1993	0		OTH	OTH	PPD (Mantoux) by Connaught;	denied any illness @ time of vax;		unk~ ()~~~In patient	SD94009	1						1	Dizziness; Injection site pain; Paraesthesia; Vasodilatation; Vertigo	FLUX~PFIZER\WYETH~4938150~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0063043	05/23/1994	MS	64.0	64		M	05/17/1994	pt recvd flu vax & 6 days later was real ill from then until 5MAR t100-103.5 24 hrs day; went into hosp 15NOV93; ATB for 40 days; temp cont; hosp 16FEB-26; vasculitis from virus; 4MAY blood clot; no sx of cold or illness until took flu shot			Y		Y	3	Y	Y	N	10/14/1993	10/21/1993	7		UNK	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Infection; Pyrexia; Thrombosis; Vasculitis	FLU3~CONNAUGHT LABORATORIES~3F41016~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0063048	05/23/1994	OH	43.0	43		F	05/16/1994	pt is partially paralyzed, not back to work yet; had GBS; pt explained that office is a pediatric office provided to pt because works upstairs; pt has no medical hx, no other info;					Y		Y			09/29/1993	12/01/1993	63		PVT	PVT				~ ()~~~In patient		1						1	Guillain-Barre syndrome; Paralysis	FLU3~PARKE-DAVIS~00763P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0065150	05/23/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt receiving 1 dose of flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27032	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0057036	05/25/1994	NC	39.0	39		F		throbbing pain bothers pt at night waking pt, pain @ the inject site, pain spread to elbow region, arm stiffness reported in pt who recvd flu vax lot# 00783P, exp 30JUN94, on 11OCT93; pt continues to have pain if arm raised above shoulders;										10/11/1993	10/12/1993	1	n/s	UNK	UNK			allergic to PCN	c/o stiffness of the injected arm, which resolved 2 dasy later w/o any treatment~ ()~~~In patient	27164	1						2	Arthralgia; Hypertonia; Injection site pain; Insomnia; Pain	FLU3~PARKE-DAVIS~00783P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0057857	05/25/1994	MD	31.0	31		F	02/22/1994	pt recvd flu vax 22OCT93 & 23OCT93 pt began to exp stiffness, muscle cramping, genl burning sensation, tiredness, inc urination, choking sensations, difficulty walking correctly & difficulty breathing;				Y						10/22/1993	10/23/1993	1	n/s	UNK	UNK	Beconase, Seldane, Alupent		asthma, allergies, pinched nerves in back from JUN93 fall	~ ()~~~In patient	28861	1						2	Arthropathy; Dysphagia; Dyspnoea; Gait disturbance; Guillain-Barre syndrome; Hypertonia; Hypokinesia; Laryngospasm; Arthralgia; Asthma; Ecchymosis; Hypokinesia; Insomnia; Jaundice; Paraesthesia; Urinary incontinence	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2|FLU3~PARKE-DAVIS~00963P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~3	USA	Emergency room visit	Influenza
0059790	05/25/1994	NJ	76.0	76		M	03/08/1994	pt recvd flu vax 14OCT93 & pt exp allergic react & hives; pt was treated w/DPH & Pred; pt exp diffuse hives;									Y	10/14/1993	10/14/1993	0	n/s	UNK	UNK	Atarax, Cogentin, Depakote, Haldol, Naproxyn, Pro-Banthine		allergic to PCN & Ditropan	~ ()~~~In patient	28047	1						2	Urticaria; Hypersensitivity; Urticaria	FLU3~PARKE-DAVIS~~UNK~IM L~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0065092	05/25/1994	TX	52.0			F	06/02/1993	GBS reported in a pt who recvd flu vax; pt taken to ER w/muscle weakness & lt leg & foot numbness; x-ray revealed compression of t12 & L1 interspacce; pt dx'd w/muscular strain & told to return if felt worse; pain in lower lt back & numbnes					Y			Y		12/01/1989	12/23/1989	22	x-ray compression of T12 & L1; MRI spinal & throracic-neg; nerve conduction test; eletrophysical eval	UNK	UNK	Synthroid, Provera, Premarin			~ ()~~~In patient	24168	1						1	Anaemia; Guillain-Barre syndrome; Hepatitis; Myasthenic syndrome; Myelitis; Nephrolithiasis; Paraesthesia; Paralysis	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation,Disabling	Influenza
0065093	05/25/1994	NY	57.0			M		pt recvd vax & was hospitalized & dx w/GBS; as of this date most of the sx have gone; pt had a sl bronchial or lung infection prior to Fluogen administration; No additional clinical details are available;					Y					12/18/1990	01/15/1991	28	N/S	UNK	UNK			sl bronchial or lung infect prior to Fluogen administration	~ ()~~~In patient	27466	1						1	Guillain-Barre syndrome	FLU3~PARKE-DAVIS~~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0065094	05/25/1994	FL	68.0			M		pt recvd vax & exp GBS; 16OCT92 exp numbness of hands & feet, & lack of balance; Pt was hospitalized for numbness &  dx by neurologist w/GBS; had some residual weakness in feet; h/o diabetes					Y					10/16/1992	10/16/1992	0		UNK	UNK			h/o diabetes	~ ()~~~In patient	22674	1						1	Coordination abnormal; Guillain-Barre syndrome; Myasthenic syndrome; Paraesthesia	FLU3~PARKE-DAVIS~~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0065095	05/25/1994	PA				U		anaphylaxis is reported in a pt who recvd flu vax (possibly Fluogen) in OCT93; reporter stated that anaphylactic episode included resp complications; No further details are known;											10/15/1993		n/s	UNK	UNK	N/S			~ ()~~~In patient	26883	1						1	Anaphylactoid reaction; Respiratory disorder	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065096	05/25/1994	MA	74.0			M	12/22/1993	GBS is reported in pt who recvd flu vax; 27OCT93 devel numbness & weakness in legs & tingling in hands; pt lost ability to ambulate; pt adm to hosp 31OCT93 to 8NOV93 w/dx of GBS;					Y				Y	10/26/1993	10/27/1993	1	nerve conductiion studies showed peripheral neuropathy	UNK	UNK	Augmentin (Amoxicillin Trihydrate/clavulanate potassium); unk ASA; Coumadin		peripheral vascular disease p/femoropopliteal bypass	~ ()~~~In patient	27334	1						1	Guillain-Barre syndrome; Hypokinesia; Myasthenic syndrome; Paraesthesia	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0065097	05/25/1994	NJ	57.0			F	12/29/1993	anaphylaxis & a rash reported in pt receiving vax; reporter stated that pt devel a severe anaphylactic react w/in 5 hrs p/vax of fluogen; pt reaction consisted of dyspnea & diffuse erythematic rash; pt was treated w/unk steroids;			Y										n/s	UNK	UNK				~ ()~~~In patient	28178	1						1	Anaphylactoid reaction; Dyspnoea; Rash	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening	Influenza
0065098	05/25/1994	KY	43.0			F	01/19/1994	GBS & short term memory loss are reported in pt who recvd flu vax; 1DEC93 pt exp onset of weakness & tingling of the extremities; pt currently noticed short term memory loss;could no long stand; hospitalized for 6 to 7 days					Y	7				09/29/1993	12/01/1993	63	n/s	UNK	UNK	Norvasc, Bumex, unk (potassium)	n/s	n/s	~ ()~~~In patient	28350	1						1	Amnesia; Asthenia; Guillain-Barre syndrome; Hypokinesia; Paraesthesia	FLU3~PARKE-DAVIS~3F41132~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0065099	05/25/1994	WA				U		failure to provide adequate ATB is reported in pt who recvd flu vax; pt recvd vax OCT92 & devel influenza MAR93; no other details known; This case was reported by a MD in the US										10/01/1992	03/01/1993	151		UNK	UNK			n/s	~ ()~~~In patient	23735	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065100	05/25/1994	FL				U		severe diarrhea is reported in pt who recvd flu vax last year; pt ate eggs 24 hrs following fluogen & exp above sx; pt has no h/o allergies to eggs;													n/s	UNK	UNK			no h/o allergies to eggs	~ ()~~~In patient	25888	1						1	Diarrhoea	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065101	05/25/1994	FL				U		pt exp severe diarrhea last  year p/flu vax; pt ate eggs 24 hrs following vax; pt has no h/o allergies to eggs;													n/s	UNK	UNK			no h/o allergies to eggs	~ ()~~~In patient	25890	1						1	Diarrhoea	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065102	05/25/1994	FL				U		severe diarrhea is reported in pt who recvd flu vax last year; pt ate eggs 24 hrs following vax & exp above sx; pt has no h/o allergies to eggs;														UNK	UNK			n/s	~ ()~~~In patient	25891	1						1	Diarrhoea	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065103	05/25/1994	FL				U		pt exp severe diarrhea w/flu vax last; pt ate eggs 24 hrs following vax; pt has no h/o allergies to eggs;													n/s	UNK	UNK			no h/o allergies to eggs;	~ ()~~~In patient	25894	1						1	Diarrhoea	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065104	05/25/1994	FL				U		pt exp severe diarrhea w/flu vax last year; pt ate eggs 24 hrs following flu vax; pt has no h/o allergies to eggs;													n/s	UNK	UNK			n/s	~ ()~~~In patient	25895	1						1	Diarrhoea	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065105	05/25/1994	FL				U		pt exp severe diarrhea w/flu vax last year; pt ate eggs 24 hrs following flu vax; pt has no h/o allergies to eggs													n/s	UNK	UNK			n/s	~ ()~~~In patient	25896	1						1	Diarrhoea	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065106	05/25/1994	CA				U		pt recvd Fluogen vax but was supossed to recvd 1993 fluogen vax instead got 1992 fluogen vax; This case is one of 3 who recvd inadvertent administration of the 1992 flu vax;										09/15/1993	09/15/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	26700	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065107	05/25/1994	CA				U		pt recvd fluogen vax but was supossed to received the 1993 vax instead to 1992 vax; This case is one of 3 pts who recvd inadvertent administartion of the 1992 vax;										09/15/1993	09/15/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	26701	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065108	05/25/1994	CA				U		pt recvd vax & was supposed to recvd 1993 fluogen vax but instead recvd 1992 fluogen vax; this case is 1 of 3 pts who recvd inadvertent administration of the 1992 vax;										09/15/1993	09/15/1993	0		UNK	UNK			NA	~ ()~~~In patient	26702	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065109	05/25/1994	RI	70.0			F		pt recvd vax w/1992 fluogen on 1OCT93 & was asymptomatic as of 8OCT93;										10/01/1993	10/01/1993	0	N/S	UNK	UNK			n/s	~ ()~~~In patient	26871	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065110	05/25/1994	IL	47.0			F	02/03/1994	inadvertent administration is reported in a pt who recvd 1st dose of Fluogen on 20JAN94; pt was given vax that expired JUN93; pt recvd a 2nd dose of vax from a non-expired lot # on 20JAN94; pt also takes Calan SR, Premarin & multivitamins;										01/20/1994	01/20/1994	0		UNK	UNK	Calan SR, Premarin, unk multivitamins w/iron	n/s	no known allergies	~ ()~~~In patient	28629	1						1	Unevaluable event	FLU3~PARKE-DAVIS~01372P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065111	05/25/1994	OH	45.0			M	03/30/1994	angioedema, generalized hives & fever are reported in pt who recvd flu vax; 4 days p/pt recvd vax pt exp angioedema, generalized hives & fever; pt treated in ER;				Y						10/20/1992	10/24/1992	4	n/s	UNK	UNK			heart disease	pt exp angioedema, generalized hives, fever w/last year's flu vax~ ()~~~In patient	28957	1						1	Angioneurotic oedema; Pyrexia; Serum sickness; Urticaria	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0065112	05/25/1994	TX	50.0			M	09/21/1993	flu-like sx are reported in pt who recvd expired flu vax w/30JUN93;										08/15/1993	09/15/1993	31		UNK	UNK				~ ()~~~In patient	26498	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~00982P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065113	05/25/1994	TX				U		tingling @ inject site & feeling of vax migrating are reported in a pt receiving 1 dose of Fluogen; approx 15 mins p/fluogen administration;														UNK	UNK				~ ()~~~In patient	26611	1						1	Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065114	05/25/1994	TX				U		tingling @ inject site & feeling of vax migrating are reported in a pt who recvd flu vax;													n/s	UNK	UNK			n/s	~ ()~~~In patient	26614	1						1	Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065115	05/25/1994	TX				U		tingling @ inject site & feeling of vax migrating are reported in a pt receiving 1 dose of flu vax;														UNK	UNK			n/s	~ ()~~~In patient	26616	1						1	Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065116	05/25/1994	TX				U		Tingling @ injection site & feeling of vax migrating are reported;														UNK	UNK				~ ()~~~In patient	26617	1						1	Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065117	05/25/1994	TX				U		Tingling @ inject site & feeling of vax migrating are reported in pt recvd 1 dose of flu vax;													n/s	UNK	UNK			n/s	~ ()~~~In patient	26618	1						1	Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065118	05/25/1994	TX				U		tingling @ inject site & feeling of vax migrating are reported in a pt receiving 1 dose of flu vax;													n/s	UNK	UNK			n/s	~ ()~~~In patient	26620	1						1	Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065119	05/25/1994	TX				U		tingling @ inject site & feeling of vax migrating are reported in a pt receiving 1 dose of flu vax;													n/s	UNK	UNK			n/s	~ ()~~~In patient	26621	1						1	Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065120	05/25/1994	TX				U		tingling @ inject site & feeling of vax migrating are reported in a pt receiving 1 dose of flu vax;													n/s	UNK	UNK			n/s	~ ()~~~In patient	26622	1						1	Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065121	05/25/1994	TX				U		Tingling @ inject site & feeling of vax migrating are reported in a pt receiving 1 dose of flu vax;													n/s	UNK	UNK			n/s	~ ()~~~In patient	26624	1						1	Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065122	05/25/1994	TX				U		tingling @ inject site & feeling of vax migrating are reported in a pt receiving 1 dose of flu vax;													n/s	UNK	UNK			n/s	~ ()~~~In patient	26625	1						1	Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065123	05/25/1994	FL	60.0			F		pt recvd vax 1 dose of vax 29SEP93 pt inadvertently was given vax IV immed following error, pt was placed on hemodialysis as prev scheduled-did not appear to be manifesting any sx resulting from inadvertent adminstration of flu vax;										09/29/1993	09/29/1993	0	n/s	UNK	UNK	Epogen, Nephrocaps, Nu-iron, Phoslo, Epoetin alfa, Dialysis vitamin supplement, polysaccharide-iron comples, calcium acetate tablets		h/o nephrosclerosis; on hemodialysis	~ ()~~~In patient	26734	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065124	05/25/1994	AL				F		nausea is reported in pt receiving 1 dose of flu vax; pt recvd flu vax on 29SEP93 & on 30SEP93; pt reported was exp above sx; this is 1 of 4 pts reported @ this site (out of 150 pts given fluogen);  pt recvd 1992 Fluogen vax last yr;										09/29/1993			n/s	UNK	UNK			pt recvd 1992 Fluogen vax last yr	~ ()~~~In patient	26765	1						1	Nausea	FLU3~PARKE-DAVIS~00973P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065125	05/25/1994	AL				M		heart racing & sweating are reported in a male pt receiving 1 dose of flu vax pt recvd vax on 29SEP93 & on 30SEP93 reported devel above sx;										09/29/1993				UNK	UNK			n/s	~ ()~~~In patient	26785	1						1	Hyperhidrosis; Palpitations	FLU3~PARKE-DAVIS~00973P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065126	05/25/1994	AL				U		nausea & pain/erythema @ inject site are reported in a pt receiving 1 dose of flu vax; pt recvd vax on 29SEP93 & on 30SEP93 exp reaction;										09/29/1993			n/s	UNK	UNK			n/s	~ ()~~~In patient	26786	1						1	Injection site hypersensitivity; Injection site pain; Nausea	FLU3~PARKE-DAVIS~00973P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065127	05/25/1994	MD	73.0			F		pt recvd vax 2OCT93 & again on 5OCT93; pt did not exp any adverse events; pt has a h/o mental retardation, cardiovascular accident, diabetes & anemia;										10/05/1993	10/05/1993	0	n/s	UNK	UNK	Glucotrol, Perdiem, Vasotec, Glipizide, Psyllium/senna, Enalapril maleate, Levothyroxine, Digoxin, Vitamin C, Ferrous sulfate, Lactulose		h/o mental retardation, cardiovascular accident, diabetes & anemia	~ ()~~~In patient	26787	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065128	05/25/1994	AL				M		periorbital swelling, periorbital itching, low grade fever & nasal congestion/sneezing are reported in pt receiving 1 dose of fluogen vax; pt recvd vax 29SEP93 & on 30SEP93 exp sx;										09/29/1993			n/s	UNK	UNK			pt previously recve fluogen vax in 1991	~ ()~~~In patient	26788	1						1	Face oedema; Pruritus; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~00973P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065129	05/25/1994	NY	55.0			M		inadvertent administration is reported in pt who recvd 1 dose of fluogen vax instead of Epogen on 7OCT93; pt was asymptomatic p/receiving the fluogen subsequent ot dialysis;										10/07/1993	10/07/1993	0		UNK	UNK	Isordil-ISosorbide dinitrate		Ventricular hypertrophy, cardiomyopathy, malignant, hypertension, renal failure; pt is on dialysis;	~ ()~~~In patient	26844	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065130	05/25/1994	TX	34.0			F	12/16/1993	redness/swelling, itching @ inject site lightheadedness, & fluttering heart are reported in pt receiving fluogen vax; pt exp immed redness & swelling @ site w/c/o lightheadedness & heart fluttering; itching;										10/06/1993	10/06/1993	0	n/s	UNK	UNK	n/s	n/s	n/s	redness/swelling/itching inject site, lightheadedness, fluttering heart~ ()~~~In patient	26873	1						1	Dizziness; Injection site hypersensitivity; Injection site oedema; Palpitations; Pruritus	FLU3~PARKE-DAVIS~00763P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065131	05/25/1994	TX				U		hot sensation around lips is reported in a pt receiving flu vax;										10/06/1993			n/s	UNK	UNK	n/s			~ ()~~~In patient	26874	1						1	Vasodilatation	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065132	05/25/1994	MS	43.0			F		painful ax nodule is reported in pt who recvd flu vax;										10/07/1993	10/08/1993	1	n/s	UNK	UNK	Premarin, Estrogen		h/o urinary tract infection 2 wks ago	~ ()~~~In patient	26892	1						1	Lymphadenopathy; Pain	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065133	05/25/1994	MS	31.0			F		painful ax nodule is reported in pt receiving flu vax;										10/07/1993	10/08/1993	1	n/s	UNK	UNK			h/o breast (fibroid) cysts (asymptomatic)	~ ()~~~In patient	26897	1						1	Lymphadenopathy; Pain	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065134	05/25/1994	MI	72.0			M		pt recvd vax & inadvertent administration is reported in a pt who recvd flu vax										10/11/1993	10/11/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	26952	1						1	Unevaluable event	FLU3~PARKE-DAVIS~00963P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065135	05/25/1994	PA	59.0			F		pt recvd vax from expired batch of fluogen;										10/11/1993	10/11/1993	0	n/s	UNK	UNK			hypertension, food allergies	~ ()~~~In patient	26954	1						1	Unevaluable event	FLU3~PARKE-DAVIS~00982P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065136	05/25/1994	MI	74.0			F		pt recvd 2 doses of fluogen on 4OCT93 & 14OCT93;										10/14/1993	10/14/1993	0	n/s	UNK	UNK	Bumex, Elavil, Ismo, Lanoxin, bumetanide, Amitriptyline HCL, Isosorbide mononitrate, Dicoxin; Flu Vax by Parke Davis 4-oct-94		h/o mild congestive heart failure; rheumatoid arthritis; hypothyroidism	~ ()~~~In patient	26980	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065137	05/25/1994	MI	79.0			F		pt inadvertently received 2 doses of fluogen on 27SEP93 & 14OCT93;										10/14/1993	10/14/1993	0	n/s	UNK	UNK	Lanoxin, Lasix, Vasotec, Digoxin, Furosemide, Enalapril malleate, Potassium		h/o mild congestive heart failure	~ ()~~~In patient	26981	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065138	05/25/1994	KY	20.0			F		vasovagal episode is reported in pt who recvd fluogen vax; pt recvd vax 6OCT93 & 5 mins p/vax pt felt lightheaded & collapsed; pt had a pulse of 60, & was not responding & had no BP; pt was given 02 & DPH;				Y						10/06/1993	10/06/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	26984	1						1	Dizziness; Hypotension; Respiratory disorder; Stupor; Syncope	FLU3~PARKE-DAVIS~01173P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0065139	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt receiving 1 dose of fluogen; sx occurred 12hrs p/flu vax & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27010	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065140	05/25/1994	CO				U		erythema, ecchymosis, pain & edeam @ inject site are reported in a pt receiving 1 dose of fluogen-sx occurred 12 hrs p/vax & resolved w/in 48 hrs of vax;										10/01/1993	10/01/1993	0	n/s	UNK	UNK				~ ()~~~In patient	27011	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065141	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt receiving vax sx occurred 12 hrs p/vax & resolved w/in 48 hrs of vax;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27013	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065142	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt receiving flu vax sx occurred 12 hrs p/vax & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27014	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065143	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in pt receiving 1 dose of fluogen sx occurred 12 hrs p/vax & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27015	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065144	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ injectt site are reported in pt who recvd flu vax sx occurred 12 hrs p/vax & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27016	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065145	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt receiving 1 dose of fluogen for influenza; above sx occurred 12 hrs p/flu vax & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27018	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065146	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site arre reported in a tp receiving 1 dose of fluogen for influenza; above sx occurred 12 hrs p/flu vax & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27019	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065147	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt receiving 1 dose of flu vax; above sx occurred 12 hrs p/flu vax & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27023	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065148	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27025	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065149	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd flu vax; above sx occurred 12hrs p/flu vax & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27031	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065151	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27033	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065152	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27034	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065153	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd flu vax; above sx occurred 12 hrs p/flu vax & fesolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27035	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065154	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27036	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065155	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27037	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065156	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27038	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065157	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd flu vax; above sx occurred 12 hrs p/vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27040	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065158	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27041	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065159	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27042	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065160	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27043	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065161	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27044	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065162	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27046	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065163	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27049	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065164	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27050	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065165	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27051	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065166	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27054	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065167	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27056	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065168	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27058	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065169	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27059	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065170	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27060	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065171	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27062	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065172	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27063	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065173	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27065	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065174	05/25/1994	CO				U		erythema, ecchymosis, pain & edema at inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27067	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065175	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27069	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065176	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27070	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065177	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt receiving 1 dos eof flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27071	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065178	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27072	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065179	05/25/1994	CO				U	10/10/1993	erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;											10/01/1993		n/s	UNK	UNK			n/s	~ ()~~~In patient	27074	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065180	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27075	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065181	05/25/1994	CO				U		erythema, ecchymosis, pain & edeam @ inject site are reported in a pt who recvd 1 dose of flu vax; above occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27076	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065182	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above occurred 12 hrs p/flu vax give & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27077	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065183	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hr p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27078	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065184	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27079	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065185	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27080	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065186	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27082	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065187	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27083	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065188	05/25/1994	CO				U		erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax & resolved w/in 48 hrs;										10/01/1993	10/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27084	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065189	05/25/1994	MI				U		hives & lightheadedness are reported in a pt who recvd 1 dose of flu vax on 18OCT93 & 5 mins later exp lightheadedness; approx 15-30 mins p/vax pt exp hives, rash w/itching all over body & ears became flushed; pt was treated w/DPH;										10/18/1993	10/18/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27090	1						1	Dizziness; Pruritus; Rash; Urticaria; Vasodilatation	FLU3~PARKE-DAVIS~00783P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065190	05/25/1994	MA	41.0			F		pt recvd vax & exp malaise & myalgia; w/in 24 hrs of vax pt exp chills w/fever, fatigue, nausea, malaise, & myalgia; w/in 48 hrs pt devel sinusitis that lasted for 1 wk;									Y	09/20/1993	09/21/1993	1	n/s	UNK	UNK			pt recvd fluogen twich previously w/o similar problems	~ ()~~~In patient	27105	1						1	Asthenia; Chills; Malaise; Myalgia; Nausea; Pyrexia; Sinusitis	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065191	05/25/1994	MA				U		vomiting, diarrhea & malaise are reported in a pt who recvd flu vax; above sx occurred w/in 24-48 hrs of vax; pt has recovered from above sx;									Y				n/s	UNK	UNK			n/s	~ ()~~~In patient	27106	1						1	Diarrhoea; Malaise; Vomiting	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065192	05/25/1994	MA				U		vomiting, diarrhea & malaise are reported in a pt who recvd 1 dose of fluogen; above sx occurred w/in 24-48 hrs of vax; pt has recovered from above sx;													n/s	UNK	UNK				~ ()~~~In patient	27113	1						1	Diarrhoea; Malaise; Vomiting	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065193	05/25/1994	MA				U		vomiting, diarrhea & malaise are reported in a pt who recvd 1 dose of flu vax; above sx occurred w/in 24-48 hrs p/vax; pt recovered;									Y				n/s	UNK	UNK				~ ()~~~In patient	27114	1						1	Diarrhoea; Malaise; Vomiting	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065194	05/25/1994	MA				U		vomiting, diarrhea & malaise are reported in a pt who recvd 1 dose of flu vax; above sx occurred w/in 24-48 hrs p/vax									Y				n/s	UNK	UNK			n/s	~ ()~~~In patient	27115	1						1	Diarrhoea; Malaise; Vomiting	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065195	05/25/1994	MA	43.0			F	10/14/1993	vomiting, diarrhea, malaise & chills w/fever are reported in a pt who recvd 1 dose of flu vax; sx occurred 24-48 hrs p/vax given; pt recovered;									Y		10/15/1993		n/s	UNK	UNK				~ ()~~~In patient	27117	1						1	Chills; Diarrhoea; Malaise; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065196	05/25/1994	IN	41.0			F		difficulty breathing, throat closing, a productive cough, & red, watery eyes are reported in a pt who recvd flu vax 18OCT93; pt is allergic to ASA & Ibuprofen; pt had a cold last wk & took Keflex & seldane D;										10/18/1993	10/19/1993	1	n/s	UNK	UNK			allergic to ASA & Ibuporfen, 1991 pt's niece tested pos for TB, pt was tested & was neg for active	~ ()~~~In patient	27126	1						1	Asthma; Conjunctivitis; Cough; Dyspnoea; Lacrimal disorder; Laryngospasm	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065197	05/25/1994	IL				U		inadvertent administration is reported in a pt who recvd a double dose of fluogen vax-2oOCT93 pt recvd 1 cc fluogen instead of .5cc fluogen IM inadvertently from a multi-dose vial; pt was asymptomatic; no other details known;										10/20/1993	10/20/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27143	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065198	05/25/1994	IL				F		2 red raised patch over deltoid, dizziness, irritability & 2 red raised patch over deltoid are reported in a female pt receiving 1 dose of flu vax; pt recvd flu vax 19OCT93 & exp above sx on 21OCT93; pha has no known allergeis;										10/19/1993	10/21/1993	2	n/s	UNK	UNK			no known allergies	~ ()~~~In patient	27146	1						1	Agitation; Dizziness; Rash	FLU3~PARKE-DAVIS~00763P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065199	05/25/1994	WV	89.0			M		inadvertent administration is reported in a pt who recvd .5cc flu vax lot# 01872P, exp 30JUN93; pt recvd expired flu vax 11OCT93; pt did not exp soreness or other apparent sx;										10/11/1993	10/11/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27155	1						1	Unevaluable event	FLU3~PARKE-DAVIS~01872P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065200	05/25/1994	WV	84.0			F		inadvertent administration is reported in a pt who recvd .5cc fluogen lot# 01872P, exp 30JUN93; pt recvd expired fluogen vax 11OCT93; pt did not exp soreness or other apparent sx;										10/11/1993	10/11/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27160	1						1	Unevaluable event	FLU3~PARKE-DAVIS~01872P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065201	05/25/1994	WV				U		inadvertent administration is reported in an pt who recvd .5cc of fluogen lot# 01872P, exp 30JUN93; pt recvd expired flu vax OCT93; pt did not exp sorness or other apparent sx;										10/15/1993	10/15/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27162	1						1	Unevaluable event	FLU3~PARKE-DAVIS~01872P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065203	05/25/1994	TX	68.0			F		sore throat is reported in a pt who recvd 1 dose of flu vax; pt recvd flu vax on 4OCT93 & exp the above sx as of 21OCT93; pt recvd flu vax for the last 5 yrs & had exp an occasional h/a;										10/04/1993	10/21/1993	17	n/s	UNK	UNK				pt recvd fluogen for the last 5 yrs & exp an occasional h/a;~ ()~~~In patient	27176	1						1	Pharyngitis	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065204	05/25/1994	IN	42.0			F	12/16/1993	itchy rash & throat felt swollen are rprtd in a pt who recvd 1 dose of flu vax recvd on 20O6CT93 & w/in 15 mins exp pruritis of neck, hands, head & rash appeared on hands & over the chest; pt went to ER because rash increased w/swelling				Y						10/20/1993	10/20/1993	0	n/s	UNK	UNK	Lo/ovral (norgestrl + Ethinyl Estradiol)			~ ()~~~In patient	27185	1						1	Face oedema; Laryngospasm; Pruritus; Rash	FLU3~PARKE-DAVIS~00193P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0065205	05/25/1994	RI	50.0			F		inadvertent use is reported in a pt who recvd flu vax on 8OCT93; on 22oct93 pt recvd a hepatitis vax & 2nd dose of fluogen; pt is asymptomatic as of 22OCT93; pt had recvd the flu vax in the past;										10/08/1993	10/22/1993	14	n/s	UNK	UNK			pt recvd flu vax in the past	~ ()~~~In patient	27193	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065206	05/25/1994	NC	69.0			M	02/16/1994	inadvertent administration & fatigue are reported in a pt who recvd 2nd dose of fluogen instead of a pneumonia vax on 21OCT93; pt had previously recvd fluogen on 7OCT93; pt recovered;									Y	10/21/1993	10/21/1993	0	n/s	UNK	UNK	n/s		n/s	~ ()~~~In patient	27199	1						1	Asthenia	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065207	05/25/1994	IL	66.0			F		hoarseness, soreness in lt deltoid, body aches, sore throat & blood shot eyes are reported in a pt who recvd 1 dose of fluogen on 15OCT93 & 3 hrs later exp the above sx; pt tx DPH & recovered;									Y	10/15/1993	10/15/1993	0	n/s	UNK	UNK				pt exp a react p/receiving fluogen several yrs ago~ ()~~~In patient	27200	1						1	Conjunctivitis; Dysphonia; Myalgia; Pharyngitis	FLU3~PARKE-DAVIS~10273P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065208	05/25/1994	OH	78.0			F		dec strength of rt hand & rt arm & numbness in rt wrist are reported in a pt who recvd 1 dose of fluogen; pt had recvd fluogen 2 wks prior to the 22OCT93 report & since 17OCT93 has exp the above sx; 19OCT93 xray of rt wrist was nl;											10/17/1993		19OCT93: rt wrist xray nl;  22OCT93: BP 132/90	UNK	UNK			polio @ age 3 hrs; weakness in shoulders & rt arm; rt wrist fracture that had completely healed;	~ ()~~~In patient	27202	1						1	Asthenia; Paraesthesia	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065209	05/25/1994	NJ				U		acting strange is reported in a pt who recvd 1 dose of fluogen;													n/s	UNK	UNK			n/s	~ ()~~~In patient	27271	1						1	Personality disorder	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065210	05/25/1994	NJ	26.0			F		erythema multiforme is reported in a pt receiving 1 dos of fluogen on 24OCT93 pt exp mild erythema multiforme on trunk, thighs & legs; pt is being treated w/atarax & Diprolene ointment; pt persisted until 1 wk course of methyl prednisone;									Y	10/24/1993	10/26/1993	2	n/s	UNK	UNK	Seldane D, Terfenadine		pt has a hx of asthma & allergies to pollen & cats;	~ ()~~~In patient	27274	1						1	Erythema multiforme	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065211	05/25/1994	FL	65.0			F		anemia, fever & cough are reported in a pt who recvd 1 dose of fluogen vax; pt recvd vax on 5OCT93 & on approx 19OCT93 exp above sx; 26OCT93 lab test results show HBG was 10 & HCT was 29.2;										10/05/1993	10/19/1993	14	26OCT93: HBG 10.0, HCT 29.2	UNK	UNK	Lodine, Premarin, Etodolac, Estrogen, Isoxsuprine		circulation problems	~ ()~~~In patient	27282	1						1	Anaemia; Cough; Pyrexia	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065212	05/25/1994	FL	74.0			M		anemia & fever of 101-102 degrees are reported in a pt who recvd fluogen vax on 29SEP93 & on 1OCT93; 7OCT93 lab tests showed HBG was 13.3 & HCT was 32.3; 12OCT93 lab tests showed HBF was 11.4 & HCT was 32.7; pt's fever has resolved;										09/29/1993	10/01/1993	2	7OCT93: HBG-13.3, HCT 32.3; 12OCT93: HBG 11.4, HCT 32.7	UNK	UNK	Minipress, Tylenol, Prazosin HCL, Acetaminophen		gallbladder surgery in 1993, allergies to Demerol & Augmentin	~ ()~~~In patient	27283	1						1	Anaemia; Pyrexia	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065213	05/25/1994	WV	45.0			F	11/01/1993	tiredness & erythema/inflammation @ inject site are reported in a pt who recvd 1 dose of flu vax; pt exp redness in inject site w/warmth & tenderness;									Y	10/25/1993	10/26/1993	1		UNK	UNK	n/s		allergy to PCN	~ ()~~~In patient	27284	1						1	Asthenia; Injection site hypersensitivity; Injection site inflammation; Injection site pain; Vasodilatation	FLU3~PARKE-DAVIS~00573P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065214	05/25/1994	CA	71.0			M		pruritic maculopapular rash is reported in a pt who recvd fluogen vax 27OCT93 @ 2PM pt recvd fluogen @ 73-PM on 27OCT93 & exp above sx;										10/27/1993	10/27/1993	0	n/s	UNK	UNK	Pravachol, Procardia XL, Tenormain, Pravastatin Sodium, Nifedipine, Atenolol		osteoarthritis, hypertension, coronary artery bypass in 1975, allergies to PNC & Pronestyl, Prostate CA dx on 10OCT93; pt previously recvd Fluogen in 1989, 1990, 1991 w/o neg reacts	~ ()~~~In patient	27321	1						1	Pruritus; Rash maculo-papular	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065215	05/25/1994	SC				F		erythema @ inject site is reported in a pt who recvd 1 dose of fluogen vax;													n/s	UNK	UNK	n/s		n/s	~ ()~~~In patient	27327	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~01073P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065216	05/25/1994	SC				F		inject site react is reported in a pt receiving 1 dose of fluogen vax;													n/s	UNK	UNK			n/s	~ ()~~~In patient	27328	1						1	Injection site reaction	FLU3~PARKE-DAVIS~01073P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065217	05/25/1994	SC	65.0			F		somnolence & cellulitis are reported in a pt who recvd flu vax; pt was treated w/Medrol dose pack; this is 1 of 3 pts reported at this site;													n/s	UNK	UNK			n/s	~ ()~~~In patient	27329	1						1	Cellulitis; Somnolence	FLU3~PARKE-DAVIS~01073P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065218	05/25/1994	OH				U		hard lump @ inject site & inadvertant administration are reported in a pt receiving 1 dose of flu vax on 1NOV93; pt was given fluogen therapy SC instead of ID;										11/01/1993	11/01/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27351	1						1	Injection site mass	FLU3~PARKE-DAVIS~~UNK~SC~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065219	05/25/1994	PA	76.0			F		chest pain, weakness, listlessness, & a sore lt arm are reported in a pt receiving fluogen vax;				Y						10/22/1993	10/24/1993	2	n/s	UNK	UNK	Cardizem, Inderal Lanoxin, Dilatiazem HCL, Propranolol HCL, Digoxin		allergy to PCN, modified radical lt mastectomy JUL93, mitral valve prolapse, hypertension	~ ()~~~In patient	27369	1						1	Asthenia; Chest pain; Malaise; Myalgia	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0065220	05/25/1994	MI				F	11/08/1993	numbness in lt arm & tingling in lt hand, & pain in hand are reported in a pt receiving 1 dose of fluogen vax; pt recvd fluogen in lt deltoid on 18OCT93 & 26OCT93 reported exp above sx; sx cont to persist as of 4NOV93; pain has inc in hand				Y					N	10/18/1993	10/26/1993	8	n/s	UNK	UNK	n/s		n/s	~ ()~~~In patient	27448	1						1	Arthralgia; Pain; Paraesthesia	FLU3~PARKE-DAVIS~00863P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0065221	05/25/1994	WA	68.0			F	02/16/1994	rotator cuff tendonitis is reported in a pt receiving 1 dose of fluogen; pt exp upper lt arm pain which was dx on 28OCT93 as tendonitis; pt was treated w/ a support sling, ice & non-steroidal anti-inflammatory meds; still pain limited ROM;				Y					N	10/18/1993	10/18/1993	0	x-ray of lt shoulder-neg	UNK	UNK			n/s	~ ()~~~In patient	27490	1						1	Hypokinesia; Pain; Tendon disorder	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0065222	05/25/1994	WA	82.0			F	02/16/1994	rotator cuff tendonitis is reported in a pt receiving 1 dose flu vax on about 12OCT93; & on 12OCT93 pt exp lt shoulder pain which was dx on 1NOV93 as tendonitis;				Y					N	10/12/1993	10/12/1993	0	n/s	UNK	UNK	n/s		pt also has a hx of rt shoulder tendonitis	~ ()~~~In patient	27491	1						1	Condition aggravated; Pain; Tendon disorder	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0065223	05/25/1994	WA	75.0			M	02/23/1994	rotator cuff tendonitis is reported in a pt receiving 1 dos of fluogen given on 13OCT93; pt noticed initial tenderness which did not resolve w/in 3-4 days; 2NOV93 pt seen for persistent pain & was dx w/tendonitis; pt recovered;				Y					Y	10/13/1993	10/13/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27492	1						1	Injection site pain; Pain; Tendon disorder	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0065224	05/25/1994	VA	55.0			F		joint pain, hardness, redness & itching @ the inject site, red streaks on arm, arm pain, & feeling feverish are reported in a pt receiving fluogen 25OCT93; pt exp redness & itchiness @ the inject site on the day of vax;				Y						10/25/1993	10/25/1993	0		UNK	UNK	Synthroid		hayfever, no allergy to eggs	~ ()~~~In patient	27498	1						1	Arthralgia; Hypokinesia; Injection site hypersensitivity; Injection site mass; Pruritus; Pyrexia; Skin discolouration; Skin striae	FLU3~PARKE-DAVIS~~UNK~SC A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0065225	05/25/1994	MI	66.0			F	11/16/1993	malaise, hot, swollen arm, redness @ inject site & painful arm are reported in a pt receiving 1 dose of fluogen vax on 30SEP93 & next day devel malaise & arm swelling & feeling of hotness in the arm; pt cont to exp tenderness & pain;										09/30/1993	10/01/1993	1	n/s	UNK	UNK			hypothyroidism, asthma & allergies to ATB	~ ()~~~In patient	27584	1						1	Injection site hypersensitivity; Injection site oedema; Malaise; Myalgia; Oedema; Pain; Vasodilatation	FLU3~PARKE-DAVIS~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065226	05/25/1994	NJ	33.0	33		F	12/08/1993	genl weakness & swelling/soreness/erythema @ inject site are reported in a pt receiving 1 dose of fluogen vax on 1NOV93; pt exp above sx on 12NOV93 which persisted; This is 1 of 2 pt's reported @ this site; pt recovered				Y					Y	11/11/1993	11/12/1993	1	n/s	UNK	UNK	n/s	n/s		~ ()~~~In patient	27591	1						1	Asthenia; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~005723~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0065227	05/25/1994	NY	93.0			M	12/20/1993	leukocytoclastic vasculitis reported in a pt receiving flu vax; pt recvd fluogen OCT93 & 4 days later devel palpable, papular purpura on lower legs; pt's MD made a dx of leukocytoclastic vasculitis;				Y						10/15/1993	10/19/1993	4	n/s	UNK	UNK			No known allergies	~ ()~~~In patient	27592	1						1	Purpura; Rash maculo-papular; Vasculitis	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0065228	05/25/1994	NJ	50.0	50		F	12/09/1993	genl weakness local erythema soreness/swelling & lightheadedness reported in a pt receiving 1 dose of vax  9NOV93; pt c/o burning pain immed following vax; pt exp erythema the size of baseball & swelling size of a quarter @ inject site;				Y					Y	11/09/1993	11/09/1993	0	n/s	UNK	UNK			allergies to PCN, Sulfa, Neomycin & Codeine	~ ()~~~In patient	27593	1						1	Asthenia; Dizziness; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pain; Skin discolouration	FLU3~PARKE-DAVIS~00573P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0065229	05/25/1994	ME				F		sore throat is reported in a pt receiving 1 dose of fluogen vax given 4NOV93; w/in a few hrs pt exp above sx; pt recovered by the following day;									Y	11/04/1993	11/04/1993	0	n/s	UNK	UNK			no known allergies	~ ()~~~In patient	27601	1						1	Pharyngitis	FLU3~PARKE-DAVIS~01063P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065230	05/25/1994	ME				F		red dots & bruise @ inject site are reported in a pt receiving 1 dose of fluogen vax given 4NOV93; on the same day pt exp bruise @ inject site w/ a rash of pinpoint, bright red dots around the inject site w/no itching;									Y	11/04/1993	11/04/1993	0	n/s	UNK	UNK			no known allergies	~ ()~~~In patient	27602	1						1	Ecchymosis; Injection site hypersensitivity	FLU3~PARKE-DAVIS~01063P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065231	05/25/1994	ME				F		diarrhea & rash on face are reported in a pt receiving 1 dose of fluogen on 4NOV93; 2-3 days following pt exp diarrhea & a rash (pinpoint bright red dots) on the skin around the eyes which abated the next day										11/04/1993	11/06/1993	2	n/s	UNK	UNK			no known allergies	~ ()~~~In patient	27604	1						1	Diarrhoea; Rash	FLU3~PARKE-DAVIS~01063P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065232	05/25/1994	ME				F		bruise @ inject site is reported in a pt who recvd flu vax 4NOV93 & the same day pt exp above sx which abated w/in several days;										11/04/1993	11/04/1993	0	n/s	UNK	UNK			no known allergies	~ ()~~~In patient	27607	1						1	Ecchymosis	FLU3~PARKE-DAVIS~01063P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065233	05/25/1994	ME				F		bruise @ inject site & chest pressure are reported in a pt receiving 1 dose of fluogen given on 4NOV93; pt exp chest pressure the following day which only lasted a few minutes; pt also exp burise @ inject site which abated the next day;										11/04/1993	11/05/1993	1	n/s	UNK	UNK			no known allergies	~ ()~~~In patient	27608	1						1	Chest pain; Ecchymosis	FLU3~PARKE-DAVIS~01063P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065234	05/25/1994	ME				F		rash on face & chest pressure are reported in a pt receiving 1 dose of fluogen vax given on 4NOV93; the folowing day pt exp chest pressure & a rash on the skin around the eyes which abated a day later;										11/04/1993	11/05/1993	1	n/s	UNK	UNK			no known allergies	~ ()~~~In patient	27609	1						1	Chest pain; Rash	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065235	05/25/1994	ME				F		rash on face & swelling around eyes are reported in a pt receiving 1 dose of fluogen on 4NOV93 & that evening pt exp rash on the skin around the eyes accompanied by swelling around the eyes which lasted 2 days;										11/04/1993	11/04/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27610	1						1	Face oedema; Rash	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065236	05/25/1994	NY	60.0			F		fever & muscle pain are reported in a pt who recvd flu vax-pt recvd 0.25cc on 6NOV93 & on 10NOV93 began to exp fever 103 for 48 hrs; muscle pain was in pt's neck & limbs;										11/06/1993	11/10/1993	4	n/s	UNK	UNK				pt exp less severe rxn w/flu vax 10 yrs ago;~ ()~~~In patient	27638	1						1	Myalgia; Neck pain; Pain; Pyrexia	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065237	05/25/1994	NE				F		achiness & pityriasis rosea are reported in a pt receiving 1 dose of fluogen vax;  pt recvd vax in fall 1993 & approx 3 wks later exp achiness & rash which was later dx as pityriasis rosea;										10/01/1993	10/22/1993	21	n/s	UNK	UNK			n/s	~ ()~~~In patient	27639	1						1	Myalgia; Rash; Rash maculo-papular	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065238	05/25/1994	NE	64.0			F		3hrs post vax pt exp nausea, vomiting & fever of 100-101 in a pt who recvd flu vax on 20OCT93; pt recovered;									Y	10/20/1993	10/20/1993	0	n/s	UNK	UNK			n/s	pt exp mild rxn w/fluogen~ ()~~~In patient	27641	1						1	Nausea; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065239	05/25/1994	ME				F		pt recvd flu vax 4NOV93 & exp local bruise @ inject site; sx abated the following day; No known allergies;										11/04/1993	11/04/1993	0	n/s	UNK	UNK			no known allergies	~ ()~~~In patient	27647	1						1	Ecchymosis	FLU3~PARKE-DAVIS~01063P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065240	05/25/1994	ME				F		pt recvd flu vax 4NOV93 & exp tiredness; pt was unable to keep eyes open which reporter stated is very unusual for the pt; sx abated the following day;									Y	11/04/1993	11/04/1993	0	n/s	UNK	UNK			no known allergies	~ ()~~~In patient	27648	1						1	Asthenia	FLU3~PARKE-DAVIS~01063P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065241	05/25/1994	FL	37.0			F	12/27/1993	pruritus, erythema, soreness & swelling @ injection site are reported in a pt receiving 1 dose of fluogen; pt recvd vax in lt deltoid on 5NOV93 & same day exp wide reddened, swollen, itchy area @ inject; tx atarax;									Y	11/05/1993	11/05/1993	0	n/s	UNK	UNK			allergy to sulfa	~ ()~~~In patient	27665	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus	FLU3~PARKE-DAVIS~00783P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065242	05/25/1994	FL	33.0	33		F	12/27/1993	pt recvd vax 8NOV93 & exp prutitus, erythema, soreness & swelling @ inject site; pt had 2 inch wide reddened, swollen, itchy area @ inject site; MD advised DPH, APAP, & warm compresses to area;									Y	11/08/1993	11/09/1993	1	n/s	UNK	UNK			n/s	~ ()~~~In patient	27669	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus	FLU3~PARKE-DAVIS~00783P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065243	05/25/1994	MI	63.0			F	01/10/1994	pt recvd vax 27OCT93 in lt arm & exp lt arm pain & chronic subacromial bursitis; pt returned to MD office on 8NOV93 c/o lt arm pain which was more noticeable when lifting; pt is continuing to c/o lt arm pain;				Y					N	10/27/1993	11/08/1993	12	n/s	UNK	UNK			osteoarthritis & unspecified vaginitis	~ ()~~~In patient	27750	1						1	Bursitis; Pain	FLU3~PARKE-DAVIS~00863P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0065244	05/25/1994	MI	65.0			F	11/24/1993	pt recvd flu vax & exp arm pain in same arm that vax was given; pt sill c/o arm pain;									N					UNK	UNK			n/s	~ ()~~~In patient	27753	1						1	Pain	FLU3~PARKE-DAVIS~00836P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065245	05/25/1994	MI	65.0			F	11/24/1993	pt recvd flu vax & exp arm pain the the same arm as vax was given; pt has recovered;									Y				n/s	UNK	UNK			n/s	~ ()~~~In patient	27754	1						1	Pain	FLU3~PARKE-DAVIS~00836P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065246	05/25/1994	MI	65.0			F	11/24/1993	pt recvd flu vax & exp arm pain in the same arm vax was administered;									Y				n/s	UNK	UNK			n/s	~ ()~~~In patient	27755	1						1	Pain	FLU3~PARKE-DAVIS~00836P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065247	05/25/1994	NJ	47.0			F		pt recvd flu vax 18OCT93 & on 21OCT93 exp severe myalgia & muscle strain; pt could not move neck; pt also exp pain in upper arm & back of neck & lt side & redness @ the inject site; pt was seen by a MD; pt devel a hive-like rash on face;				Y					Y	10/18/1993	10/21/1993	3	n/s	UNK	UNK			n/s	~ ()~~~In patient	27766	1						1	Hypokinesia; Injection site hypersensitivity; Myalgia; Neck pain; Pain; Rash; Urticaria	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0065248	05/25/1994	NJ	46.0			F		pt recvd flu vax 25OCT93 & 27OCT93 exp redness & pain @ the inject site w/a 3.5cm area of burning which was hot to the touch; pt was seen by MD & given Keflex & APAP;				Y					U	10/25/1993	10/27/1993	2	n/s	UNK	UNK			n/s	~ ()~~~In patient	27770	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PARKE-DAVIS~01163P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0065249	05/25/1994	MN	48.0			F	01/14/1994	pt recvd flu vax 26OCT93 & 27OCT93 c/o throat felt scratchy; pt devel a sinus infection, a burning feeling in lungs & throbbing pain in the arm that inject was given; arm throbbed 4 days p/vax; pt took advil but discont when stomach pain										10/26/1993	10/27/1993	1	blood sugars elevated at 211 to 296	UNK	UNK	Premarin		allergy to Thimerosal; diabetes controlled by diet & exercise	~ ()~~~In patient	27811	1						1	Abdominal pain; Chest pain; Hyperglycaemia; Infection; Lung disorder; Pain; Pharyngitis; Sinusitis	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065250	05/25/1994	GA				M		pt recvd flu vax & exp flu-like react;													n/s	UNK	UNK			n/s	~ ()~~~In patient	27837	1						1	Influenza	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065251	05/25/1994	IA	39.0			F	12/03/1993	pt recvd flu vax 10NOV93 & immed following vax pt exp pain & limited motion in arm in arm inject was given;									N	11/10/1993	11/10/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27838	1						1	Hypokinesia; Pain	FLU3~PARKE-DAVIS~00873P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065252	05/25/1994	MA				U	12/06/1993	pt recvd flu vax 15NOV93 & approx 1-2 wks p/vax pt broke out in herpes zoster;										11/15/1993	11/15/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27843	1						1	Herpes zoster	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065253	05/25/1994	MA				U	12/06/1993	pt recvd flu vax 15NOV93 & approx 1-2 wks p/vax pt broke out in herpes zoster;										11/15/1993	11/15/1993	0	n/s	UNK	UNK			n/s	~ ()~~~In patient	27844	1						1	Herpes zoster	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065254	05/25/1994	MA				U	12/06/1993	pt recvd flu vax 1NOV93 & approx 1-2 wks p/vax pt broke out in herpes zoster;										11/01/1993	11/15/1993	14	n/s	UNK	UNK			n/s	~ ()~~~In patient	27845	1						1	Herpes zoster	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065255	05/25/1994	MA				U	12/07/1993	pt recvd flu vax 1NOV93 & approx 1-2 wks p/vax pt broke out in herpes zoster;										11/01/1993	11/15/1993	14	n/s	UNK	UNK			n/s	~ ()~~~In patient	27848	1						1	Herpes zoster	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065256	05/25/1994	MA				U	12/07/1993	pt recvd flu vax 1NOV93 & approx 1-2 wks p/vax pt broke out in herpes zoster;										11/01/1993	11/15/1993	14	n/s	UNK	UNK			n/s	~ ()~~~In patient	27849	1						1	Herpes zoster	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065257	05/25/1994	WA				F	12/17/1993	pt recvd flu vax & exp rt facial paralysis in eyelid, forehead, cheeks, lips & chin 2 days p/vax;													n/s	UNK	UNK	Estraderm		n/s	~ ()~~~In patient	28022	1						1	Facial palsy	FLU3~PARKE-DAVIS~00763P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065258	05/25/1994	FL				F	12/17/1993	pt recvd flu vax 1OCT93 & exp an unspecified react;										10/01/1993			n/s	UNK	UNK			n/s	~ ()~~~In patient	28024	1						1	Unevaluable event	FLU3~PARKE-DAVIS~1263P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065260	05/25/1994	OH	39.0			F	02/14/1994	pt recvd flu vax 10NOV93 & stated immed c/o of a sore lt arm; the discomfort lasted 2 months & pt exp tingling & weakness in lt hand; tx included APAP & heat for arm discomfort;									Y	11/10/1993	11/10/1993	0	n/s	UNK	UNK			as a child, pt had a broken lt arm in the same area	~ ()~~~In patient	28055	1						1	Asthenia; Injection site pain; Myalgia; Paraesthesia	FLU3~PARKE-DAVIS~01263P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065261	05/25/1994	OH	1.3	1	.3	F	02/14/1994	pt recvd flu vax 3NOV93 & c/o sore arm 23NOV93-pt stated arm was broken; 24NOV93 xray of the arm revealed no fracture; pt prev c/o arm pain JUL93;				Y					Y	11/03/1993	11/23/1993	20	24NOV93 xray revealed no fracture	UNK	UNK	Feosol, furosemide, Isosorbide, Potassium chloride, Pred, Accetaminophen, Hydroxyzine HCL, Lorazepam, Petrolatummineral oil/mineral wax, Granulex, Triamcinolone		renal insufficiency, gout, dermatitis, allergic to diltiazem hydorchloride & Cephalexin	~ ()~~~In patient	28060	1						1	Injection site pain; Myalgia; Pain	FLU3~PARKE-DAVIS~01263P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0065262	05/25/1994	WA	23.0	23		M	12/21/1993	pt recvd flu vax 26OCT93 & 28OCT93 exp hives; pt treated in ER w/Adrenalin inject; also treated w/DPH;				Y					Y	10/26/1993	10/28/1993	2	n/s	UNK	UNK			hayfever	pt exp itching @ inject site p/1992 flu shot~ ()~~~In patient	28096	1						1	Urticaria	FLU3~PARKE-DAVIS~00673P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0065263	05/25/1994	IA	45.0			F	01/13/1994	pt recvd vax 5NOV93 & 13DEC93 pt underwent routine physical which revealed liver enzymes were elevated; AST, ALT, Bilirubin & GGT were all elevated; pt also noticed inc fatigue; hepatitis screening was neg for Hep A,B & C;				Y						11/05/1993	12/13/1993	38	hepatitis screening-neg for Hep A, B, C	UNK	UNK			allergies to dust & molds; gald bladder removed	~ ()~~~In patient	28292	1						1	Alanine aminotransferase increased; Aspartate aminotransferase increased; Asthenia; Hepatic function abnormal; Hyperbilirubinaemia	FLU3~PARKE-DAVIS~01293P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0065264	05/25/1994	GA				U	01/21/1994	pt recvd flu vax & pt devel flu;														UNK	UNK				~ ()~~~In patient	28406	1						1	Drug ineffective	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065265	05/25/1994	GA				U	01/21/1994	pt recvd flu vax & devel flu														UNK	UNK				~ ()~~~In patient	28407	1						1	Drug ineffective	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065266	05/25/1994	GA				U	01/21/1994	pt recvd flu vax & devel the flu														UNK	UNK				~ ()~~~In patient	28408	1						1	Drug ineffective	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065267	05/25/1994	GA				U	01/21/1994	pt recvd flu vax & devel flu														UNK	UNK				~ ()~~~In patient	28410	1						1	Drug ineffective	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065268	05/25/1994	GA				U	01/21/1994	pt recvd flu vax & devel the flu														UNK	UNK				~ ()~~~In patient	28411	1						1	Drug ineffective	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065269	05/25/1994	GA				U	01/21/1994	pt recvd flu vax & devel the flu														UNK	UNK				~ ()~~~In patient	28412	1						1	Drug ineffective	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065270	05/25/1994	GA				U	01/21/1994	pt recvd flu vax & devel the flu														UNK	UNK				~ ()~~~In patient	28413	1						1	Drug ineffective	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0065271	05/25/1994	CO	65.0			M	02/01/1994	pt recvd vax 26OCT93 & 27OCT93 around 530AM pt awoke w/ringing in ears, which persists; pt described sx as ringing in ears which is worse @ noc; fullness in ears, which seems worse on rt side & h/a;									N	10/26/1993	10/27/1993	1		UNK	UNK			Turbinectomy, PCN & Monosodium Glutamate allergies;	pt recvd a flu vax 1991 & shortly p/exp a bad cold~ ()~~~In patient	28561	1						1	Ear disorder; Headache; Tinnitus	FLU3~PARKE-DAVIS~00973P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0065272	05/25/1994	WI	1.7	1	.7	F	03/22/1994	pt recvd flu vax 15OCT93 & devel weakness & couldn't get out of bed unassisted; pt had no power or strength in grip, had pains in knees, hips, shoulders & hands; had no use of lt arm for 3 wks; pt also limite use of rt arm; pt seen by MD;				Y						10/15/1993	10/17/1993	2	n/s	UNK	UNK			n/s	~ ()~~~In patient	28664	1						1	Arthralgia; Arthropathy; Asthenia; Hypokinesia; Pain	FLU3~PARKE-DAVIS~01173P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0065273	05/25/1994	NC	66.0			F	02/10/1994	pt recvd flu vax 16NOV93 & pt felt hot in the waiting room p/vax; pt seen in ER-MD felt pt had bad react to the flu vax; pt shaky; pt exp difficulty walking, pounding head, hot sensation & shakiness;				Y					Y	11/16/1993	11/16/1993	0	n/s	UNK	UNK			diabetes	~ ()~~~In patient	28699	1						1	Headache; Hypokinesia; Tremor; Vasodilatation	FLU3~PARKE-DAVIS~00573P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0065275	05/25/1994	NC	66.0	66		F	03/17/1994	pt recvd flu vax 9NOV93 & had pain in lt arm when lifted the arm; pt's husband reported arm pain still persists; pt's arm was x-rayed;				Y				Y	N	11/09/1993	11/09/1993	0	n/s	PVT	UNK	Vasotec, hydrochlorothiazide;	none	hypertension, hypercholesterolemia, adult diabetes mellitus;	~ ()~~~In patient	29249	1						1	Hypertonia; Injection site pain; Pain	FLU3~PARKE-DAVIS~00863P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Disabling	Influenza
0063118	05/27/1994	AZ	28.0	28		M	05/11/1994	pt recvd vax & exp syncopal episode, falling backwards & striking occiput of head LOC lasted less than 10 sec but was disoriented exp some slurred speech & rt sided weakness w/in 30 mins had returned to nl & was transported to hosp;				Y					Y	11/22/1991	11/22/1991	0	C-spine nl; CT scan no evidence of blood;	PVT	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	AZ9414	1						1	Confusional state; Myasthenic syndrome; Speech disorder; Syncope	FLU3~PFIZER\WYETH~314963~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0063218	06/02/1994	MT	81.0	81		M	05/24/1994	polyneuropathy p/influenza vax;					Y		Y	Y	N	10/08/1993	11/01/1993	24	nerve conduction, spinal fluid eval;	OTH	UNK		parkinson	intestinal pseudo-obstruction	unk~ ()~~~In patient		1						1	Neuropathy	FLUX~PFIZER\WYETH~4938145~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0063249	06/03/1994	MA	8.0	8		F	05/23/1994	pt exp many colds this winter & mom felt may have been a result of the flu shot; dad felt flu shot may be causing Guillain barre; has had numbness & tingling has been ill alot this winter; fevers, colds several dasy, muscle aches then fine										11/12/1993				PVT	PVT			learning disability/sensory integration problems, asthma, eczema;	~ ()~~~In patient		1						1	Infection; Malaise; Myalgia; Paraesthesia; Pharyngitis; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~3F41122~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0063250	06/06/1994	GA	55.0			M	05/28/1994	Guillian Barre Synd;									U	01/10/1994	01/24/1994	14		UNK	UNK				~ ()~~~In patient	CO5413	1						1	Unevaluable event	FLU3~CONNAUGHT LABORATORIES~3F41114~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0063289	06/06/1994	TN	64.0	64		F	06/01/1994	pain in teeth; burning sensation in mouth;									N	10/06/1993			pt has was found to have heamchromotosis;	PVT	PVT		lassitude, pharyngitis;		~ ()~~~In patient		1						1	Haemochromatosis; Pain; Stomatitis; Weight decreased	FLU3~CONNAUGHT LABORATORIES~3F41008~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0063291	06/07/1994	MD	43.0	43		F	12/20/1993	pt recvd vax 24NOV03 & exp chills, fever, muscle aches, bronchitis; sx persisted as of today 20DEC93 but less severe; however now has laryngitis;									N	11/24/1993	12/07/1993	13	NONE	PUB	UNK	Theodore;	NONE	asthma-bronchitis in October	Unk~ ()~~~In patient	MD93060	1						1	Bronchitis; Chills; Laryngitis; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41122~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0063292	06/07/1994	MD	52.0	52		F	10/25/1993	pt recvd vax 22OCT93 & exp hives; had itching; lightheaded;									Y	10/22/1993	10/22/1993	0		PUB	PUB	Bromfed;	NONE	multiple allergies; PNC, dust, mold, pollen, grass, trees;	NONE~ ()~~~In patient	MD94009	1						1	Dizziness; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~3F41027~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0063294	06/07/1994	MD	38.0	38		F	10/28/1993	h/a frontal starting 26OCT; cont to the present; soreness lt side of neck;									U	10/26/1993	10/27/1993	1		PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MD94008	1						1	Headache; Neck pain	FLU3~PARKE-DAVIS~3F41027~3~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0063298	06/07/1994	NY	75.0	75		F	06/03/1994	burning (urination) frequency bladder infl/trouble sitting; tests urine C&S/upr G.I./Sigmoidospy/bone scan; cystoscopy/CT scan;				Y						10/30/1990	10/30/1990	0	Urine C&S, Upr GI/Sigmoidocopy, bone scan, cystscopy/ CT scan;	PVT	PVT	Cardizem, B-12 shots;	NONE	hypertension & pernicious anemia;	~ ()~~~In patient		1						1	Dysuria; Pollakiuria	FLU3~LEDERLE LABORATORIES~~UNK~~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|TTOX~SCLAVO~~UNK~~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0063299	06/07/1994	NY	78.0	78		F	06/03/1994	burning urination frequency, bladder infl/trouble sitting; tests urine C&S/upr G.I./ sigmoidocopy/bone scan;cystscopy/ct scan;				Y						09/17/1993	09/19/1993	2	Urine C&S/upr G.I/sigmoidoscopy/bone scan/cystscopy/CT scan;	PVT	PVT	Cardizem, B-12 shots;	NONE	hypertension & pernicious anemia;	pt exp burning urination frequency, bladder infl/trouble sitting w/Tet & flu #1~ ()~~~In patient		1						1	Condition aggravated	FLU3~PFIZER\WYETH~359908~UNK~~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0063301	06/07/1994	TX	0.2			M		generalized tonic-clonic; sz activity;										04/14/1994	04/15/1994	1		UNK	UNK			prematurity, abnormal CT;	~ ()~~~In patient		1						1	Convulsion	DTP~UNKNOWN MANUFACTURER~~UNK~IM~~DTP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|OPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, ORAL (NO BRAND NAME)~1	USA		Influenza
0063367	06/10/1994	OH	22.0	22		F	05/21/1994	lt upper quad pain sx began approx 2-2 1/2months p/vax; no other known exposure; no routine medications; ultrasound spleen 9FEB94; enlarged spleen;									U	11/08/1993	02/04/1994	88	ultrasound spleen 9FEB94; enlarged spleen;	PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Pain; Splenomegaly	FLUX~PFIZER\WYETH~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0063389	06/13/1994	CA	37.0	37		F	01/14/1994	pt states vomited 2 days ago & once yesterday, not today at all; pt states is emotionally distraught;  pt states caught a cold-thinks has temp but hasn't taken it w/thermometer; t97.8, lungs very wheezy; SOB, poss rapid speech, & smoking;										01/11/1994	01/12/1994	1		PUB	PUB		back pain, prior flu; MH severe resp;	NKA-asthma, smokes-7 packs a day, former drug addict;	~ ()~~~In patient	CA94078	1						1	Affect lability; Asthma; Dyspnoea; Pyrexia; Vomiting	FLUX~PFIZER\WYETH~4938148~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0063391	06/13/1994	CA	67.0	67		F	11/19/1993	swelling & tenderness rt upper arm to include elbow;									Y	11/17/1993	11/18/1993	1	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	CA94080	1						1	Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~4938148~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~330948~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0060003	06/20/1994	TX	22.0	22		M	06/16/1994	pt recvd vax & exp GBS; started w/neck hurting, back & tail bone hurting; seen by MD & treated w/ATB; then started to devel weakness & was hospitalized on 14JAN94 for 43 days; also devel weakness in legs;					Y	43			U	11/23/1993	12/15/1993	22		PUB	OTH	NONE			~ ()~~~In patient	CO5435	1						3	Guillain-Barre syndrome; Neuropathy; Guillain-Barre syndrome; Back pain; Myasthenic syndrome; Neck pain; Neuropathy	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~3F41124~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~3F41124~1~~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Hospitalisation	Influenza
0063894	06/29/1994	IL	40.0			F	06/20/1994	poss GBS started w/bilateral facial palsy & weakness in rt arm; had diminished or absent reflexes in lower extremities; pt was hospitalized in 2 different hospitals;  non-conclusive neuro findings; GBS is r/o dx; still c/o weakness;				Y	Y				N					UNK	UNK				~ ()~~~In patient	CO5438	1						1	Asthenia; Facial palsy; Guillain-Barre syndrome; Hyporeflexia; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0063926	06/30/1994	WA	51.0	51		F	06/23/1994	severe react lost 2 wks work-could not breathe; exp onset of stroke like weakness 8MAR90; dx CFS-dx EBV;				Y				Y	N	10/30/1989	11/07/1989	8	pos titers: EBV AUG1991; cortisol level .41;	PVT	UNK		NONE	NONE	pt exp resp rxn @ 48 y/o w/flu dose #1;~ ()~~~In patient		1						1	Asthenia; Dyspnoea; Infection	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0064504	07/07/1994	TN	67.0	67		F	06/09/1994	pt recvd vax; pt devel paresis of all four extremities; dx: transverse myelitis;				Y	Y			Y	N	10/11/1993	11/06/1993	26	MRI of c spine: results not provided;	PVT	OTH	procardia xl / premarin; dyazide / motrin;	none;	hypertension; arthritis;	none;~ ()~~~In patient	940120401	1						1	Muscle atrophy; Myasthenic syndrome; Myelitis; Neuropathy; Pain; Quadriplegia	FLU3~PFIZER\WYETH~361923~2~A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation,Disabling	Influenza
0064627	07/12/1994	WA	37.0	37		F	02/10/1994	pt recvd vax & felt flushed & SOB x 30-40mins p/vax; came to ER; has 2 hives near site of inject; doing fine otherwise; ER MD reported hx of ? react to TD vax 3-4 yrs ago;				Y					Y	02/10/1994	02/10/1994	0		PUB	OTH		NONE	NKA to meds; hx of allergies to dog, cat, etc;	pt exp react to Td vax 3-4 yrs ago;~ ()~~~In patient	WA941055	1						1	Dyspnoea; Injection site hypersensitivity; Vasodilatation	FLU3~PFIZER\WYETH~361921~1~IM~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0064639	07/12/1994	WA	54.0	54		F	04/08/1994	pt recvd vax; upper arm where shot given goes up into shoulder like tooth ache;									N	02/01/1994	02/02/1994	1	none;	PUB	PUB	none;	none;	none;	pt had inc fever, delusion w/ small pox vax at age 6;~ ()~~~In patient	WA941069	1						1	Injection site pain; Pain	FLU3~PFIZER\WYETH~361921~1~~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0064708	07/14/1994	KY	3.0	3		M		pt recvd vax; pt felt sleepy & lethargic ; t104.1; stiffened eye rolled back in head; pt given APAP & iv fluids; pt had macupapular rash;				Y					Y	11/17/1993	11/17/1993	0	WBC 5.4; reticulocte count 1.6; INR 1.1;	PUB	PUB	none;	pt well by par report;	chronic sinusitis; otitis; lactose intolerance;	none;~ ()~~~In patient	KY940002	1						1	Gaze palsy; Hypertonia; Pyrexia; Rash maculo-papular; Somnolence	FLUX~PFIZER\WYETH~4938187~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0066421	07/14/1994	PA	5.0	5		F	11/01/1993	pt recvd vax & w/in 24 hrs p/vax pt exp itching & urticaria @ DTAP inject site; react was approx 10cm; same peripheral urticaria was present; tx included antihistamines & steroids; pt recovered;				Y					Y	10/20/1993	10/21/1993	1	NONE	PVT	PVT	NONE	healthy	full-term; allergic to blue dye	pt slept 6 hrs, screamed 6 hrs, & had temp of 102 following prior DTP;~ ()~~~In patient	930229201	1						1	Injection site hypersensitivity; Pruritus; Urticaria	DTAP~PFIZER\WYETH~356918~1~IM~RA~DTAP (ACEL-IMUNE)~1|FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0064770	07/18/1994	LA	25.0	24		M	07/04/1994	pt recvd vax exp severe flu & almost died;			Y						Y	11/01/1957	11/01/1957	0	none;	MIL	MIL	APC tablets;	none	had pneumonia as child & sunstroke also; head injury-was hit w/baseball bat;	~ ()~~~In patient		1						1	Drug ineffective; Influenza	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0061058	07/20/1994	NY	70.0			F	06/13/1994	pt recvd vax & devel painful stiff neck; devel limp(dx as left foot drop); had also flu in feb; neck pain secondary to builging disc (c4-5, c6-7) w/possible disc herniation (c-3-4);				Y				Y	N	10/12/1992			impression: rt lateral bulge or herniation at the c3-c4 level w/ disc bulging appreciated at c4-c5 & c6-c7; mri reports available;	PVT	PVT	none;	none;	dx of amyotrophic lateral sclerosis;	n/a;~ ()~~~In patient	930127001	1						2	Apnoea; Cardiac failure; Neck pain; Neuropathy; Nuchal rigidity; Peroneal nerve palsy; Pruritus; Speech disorder; Gait disturbance; Influenza; Neck pain; Neuropathy; Nuchal rigidity; Peroneal nerve palsy	FLU3~PFIZER\WYETH~337916~1~A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|FLU3~LEDERLE LABORATORIES~337916~UNK~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~2	USA	Disabling	Influenza
0062209	07/20/1994	WA				F	04/11/1994	pt recvd vax & devel severe flu infect & viremia & the fetus died; pt suffered a ruptured uterus & required a hysterectomy coincident w/ these events;				Y	Y				U	10/01/1993	12/01/1993	61	test result for potency(by serial radio-immuno diffusion assay), physical inspection, & animal safety tests on retained samples of lot #4938137, yielded results in conformance to product specifications;	PVT	PVT		none;	none;	~ ()~~~In patient	894103004A	1						2	Drug ineffective; Foetal disorder; Infection; Influenza; Stillbirth; Drug ineffective; Infection; Influenza; Stillbirth; Uterine rupture	FLUX~PFIZER\WYETH~4938137~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938137~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0057857	08/01/1994	MD	31.0	31		F	07/28/1994	pt recvd flu shot 22OCT93 & was stiff from neck to knee, burn from neck to knees; skin burns, pressure on neck; shake real bad, arms locked at elbows, trouble breathing, wheezed bad, bad asthma, hard time swallowing, lost all my strength;				Y					U	10/22/1993	10/23/1993	1		PUB	OTH	Beconase, Seldane, Alupent, BCP	NA	asthma, allergies, hurt back (pinched nerves)	NA~ ()~~~In patient		1						3	Arthropathy; Dysphagia; Dyspnoea; Gait disturbance; Guillain-Barre syndrome; Hypertonia; Hypokinesia; Laryngospasm; Arthralgia; Asthma; Ecchymosis; Hypokinesia; Insomnia; Jaundice; Paraesthesia; Urinary incontinence	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2|FLU3~PARKE-DAVIS~00963P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~3	USA	Emergency room visit	Influenza
0059151	08/01/1994	MD	57.0	57		F	01/27/1994	pt recvd flu vax OCT93 & the next day exp fever in arm from elbow to shoulder & redness about size of a fifty cent piece; sx resolved by the next day; 1 wk later pt presented to MD w/a sore throat, aching, productive cough, chills, & t101.5				Y					U	10/04/1993	10/11/1993	7		PVT	PVT	unk	NONE	pt is allergic to sulfa drugs;	~ ()~~~In patient	894122003A	1						2	Chills; Cough; Diarrhoea; Myalgia; Pharyngitis; Productive cough; Pyrexia; Speech disorder; Chills; Cough; Diarrhoea; Malaise; Myalgia; Pharyngitis; Pyrexia; Vasodilatation	FLUX~PFIZER\WYETH~4938178~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938178~5~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0066434	08/01/1994	NC	65.0	65		F	11/05/1993	pt recvd vax & devel a macular rash 5 to 7 days later x 2 to 3 wks; pt was seen by a dermatologist who thought it was an allerg react to the vax; on f/u pts husband MD noted that pt recvd flu vax w/o incident felt rash of unk etiology;				Y					Y	10/19/1990				PVT	PVT	Synthroid tablets, Premarin, Provera;	unk	pt had encephalopathy associated w/swine flu vax in 1976;	NONE~ ()~~~In patient	893314012J	1						1	Hypersensitivity; Rash maculo-papular	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0066435	08/01/1994	WA				M	04/11/1994	MD was vaxed w/flu vax in OCT93; pt devel severe influenza in DEC93 which lasted for 1 month;									Y	10/01/1993	12/01/1993	61	Nasal cultures were pos for H3N2 influenza;	PVT	PVT	unk	NONE		NONE~ ()~~~In patient	894103005A	1						1	Drug ineffective; Infection; Influenza	FLUX~PFIZER\WYETH~4938137~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0066436	08/01/1994	IA	66.0	66		F	04/01/1994	pt devel polyarthralgias w/joint swelling coincident w/administration of flu vax; f/u nurse reporter noted that pt had also devel a fever of 100 to 101;				Y					U	10/28/1993				PVT	OTH		unk	unk		894117009A	1						1	Arthralgia; Myalgia; Osteoarthritis; Pyrexia	FLUX~PFIZER\WYETH~4938142~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0066438	08/01/1994	MO	55.0	54		M	04/27/1994	pt devel redness, swelling & itching @ inject site, coincident w/flu vax; react lasted about 1 month; f/u pt noted that also exp visual disturbance & fever sore;									Y	10/19/1993	10/20/1993	1		OTH	OTH	NONE	NONE		~ ()~~~In patient	894124006A	1						1	Injection site hypersensitivity; Injection site oedema; Mouth ulceration; Pruritus; Visual disturbance	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0066439	08/01/1994	WI	57.0	56		F	05/02/1994	pt devel a red edematous area which was painful to the touch & generalized achiness coincident w/a flu inject;									Y	10/19/1993	10/21/1993	2		OTH	PVT	unk	NONE	NONE	~ ()~~~In patient	894143005A	1						1	Myalgia; Oedema; Pain; Vasodilatation	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0066440	08/01/1994	WI	57.0	57		F	05/02/1994	pt recvd flu vax & devel a three-inch reddish circle that was hot & pruritic @ the inject site;									N	10/15/1993	10/17/1993	2		OTH	PVT	unk	NONE		~ ()~~~In patient	894143006A	1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0066441	08/01/1994	WI	52.0	52		F	05/02/1994	pt recvd flu inject & devel a hot, painful, pruritic area 94 inches in diameter) @ the inject site that resolved in 1 wk;									Y	10/15/1993	10/17/1993	2		OTH	OTH	unk			~ ()~~~In patient	894143007A	1						1	Injection site pain; Pruritus; Vasodilatation	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0066442	08/01/1994	WI	30.0	30		F	05/02/1994	pt recvd vax & exp pruritus @ the inject site for about 1 day;									Y	11/03/1993	11/05/1993	2		OTH	PVT	unk	NONE		~ ()~~~In patient	894143008A	1						1	Pruritus	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0066443	08/01/1994	SD	68.0	68		F	05/23/1994	pt recvd vax 9NOV93 & devel a rash on chest, abdo, inner arms, & legs; pt was treated w/ATB, oral Pred, & topical lotion; however rash persists;				Y					N	11/09/1993	11/24/1993	15	skin biopsy was pos for flu vax;	PVT	OTH	inhaler used for asthma inhalant	NONE	pt has a hx of asthma;	~ ()~~~In patient	894152001A	1						1	Dermatitis bullous; Erythema multiforme; Oedema; Rash	FLUX~PFIZER\WYETH~~4~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0066444	08/01/1994	NY	33.0			F	06/10/1994	pt devel cold like sx in early OCT93; MD prescribed medication & administered flu vax; over the next 24 hrs pt devel a flu-like illness characterized by fever, nausea, fatigue, chills, dizziness, h/a & generalized aches; dx w/lyme disease				Y					N	10/14/1993				OTH	OTH	Not specified	pt had cold like sx		~ ()~~~In patient	894167005A	1						1	Asthenia; Dizziness; Gastrointestinal disorder; Infection; Influenza; Myalgia; Pyrexia; Respiratory disorder	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0066445	08/01/1994	KY	38.0	38		F	06/14/1994	pt recvd flu vax & devel a sterile abscess, which was treated w/ATB, incision, & drainage; abscess resolved, however, recurred approx 6 months later; pt is to undergo lancing of the sterile abscess again;				Y					U	10/01/1993	11/01/1993	31		PVT	OTH		NONE	NONE	~ ()~~~In patient	894182001A	1						1	Abscess	FLUX~PFIZER\WYETH~4938147~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0066544	08/01/1994	CA	72.0	72		M		pt recvd vax & devel large areas of redness & swelling which were hot to touch on the arm following vaax;									U	10/01/1993	10/03/1993	2	no relevant data;	OTH	OTH			Hypothyroidism	~ ()~~~In patient	WAES93100186	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Vasodilatation	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~0767V~1~~~PNEUMO (PNEUMOVAX)~1|TYP~UNKNOWN MANUFACTURER~~2~SC~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0066545	08/01/1994	CA	75.0	75		F		pt recvd vax & devel large areas of redness & swelling which were hot to the touch on the arm following vax;									U	09/27/1993	09/29/1993	2	no relevant data;	OTH	OTH			Cancer, tongue;HGN;osteoarthritis;hernia, hiatal	~ ()~~~In patient	WAES93100187	1						1	Oedema peripheral; Vasodilatation	FLU3~PARKE-DAVIS~~3~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~0767V~1~SC~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0066551	08/01/1994	NV	50.0	50		F		pt recvd vax & the following day devel a fever of 101.6, was little hot, 2 x 2 edema described by MD as a huge 12 x 12 cm induration @ inject site; also swelling 13x12 cm red area, itching @ inject site; arm was tender & hot;				Y					Y	10/06/1993	10/06/1993	0	no relevant data;	PVT	OTH	Cardizem SR, Lozol, Theo-Dur, Premarin, Maxair, Azmacort, Intal, Allergy shots, DPH, Xanax, Seldane;		asthma; hypertension; allergy, PCN; allergy, sulfa; allergy, ASA; allergy, IVP dye; allergy environmental; allergy, codeine; allergy, compazine; allergy, ace inhibitor;	~ ()~~~In patient	WAES93100486	1						1	Hypokinesia; Injection site hypersensitivity; Injection site mass; Injection site oedema; Lymphadenopathy; Pain; Pruritus; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0066556	08/01/1994	CT	72.0	72		M		pt recvd vax & devel herpes zoster on lt side of forehead & scalp @ first division of trigeminal nerve on 15OCT93; MD did not think that the pts exp was related to vax; pt had rash which resembled chicken-pox;									U	10/13/1993	10/15/1993	2	No relevant data;	OTH	OTH				~ ()~~~In patient	WAES93101555	1						1	Herpes zoster; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0066572	08/01/1994	WA				U		pt recvd vax & devel thrombocytopenic purpura; It was noted that the pt was on multiple other medications; No further details were provided;									U				No relevant data;	OTH	OTH	Multiple other meds;			~ ()~~~In patient	WAES94010400	1						1	Thrombocytopenic purpura	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0066576	08/01/1994	TX	3.0	3		M		pt recvd vax 26JAN94 & 27JAN94 devel 5-6cm localized red area, fever, infected ears, congestion & rales; chest x-ray on 31JAN94 revealed pneumonia in the lt lower lobe of the lung & t101.6; 3FEB94 pt noted to have dec appetite;				Y					U	01/26/1994	01/27/1994	1	31JAN94 CXR lt lower lung pneumonia;	PVT	PVT				pt exp vomit, cold sxs, earache @ 41 mos w/pneumovax 2nd dose;~ ()~~~In patient	WAES94020049	1						1	Anorexia; Injection site hypersensitivity; Lung disorder; Otitis media; Pneumonia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~3~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0055549	08/30/1994	AL	63.0	63		F	10/20/1993	pt recvd vax 1OCT92 & exp muscle & joint pain/aches; onset date of sx in unclear; last ofice visit 12OCT92; nl exam;				Y					N	10/01/1992			elevated sed rate; C-reactive protein neg lyme antibody test; nl uric acid (3.1)	PVT	PVT	Premarin, Synthroid	muscle & joint aches	Hypothyroidism; allergic to PCN, Sulfa, Sodium benzoate-Preservative; pt had recvd 2 prev Fluogen 7OCT91 & 15DEC89;	NONE~ ()~~~In patient	930229001	1						3	Condition aggravated; Red blood cell sedimentation rate increased	FLU3~PARKE-DAVIS~00682P~3~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~3|PPV~PFIZER\WYETH~312944~1~IM A~~PNEUMO (PNU-IMUNE)~3	USA	Emergency room visit	Influenza
0066627	08/30/1994	FL	68.0	68		F		pt recvd vax & approx 4 wks later pt began exp muscle pain & cramps in rt leg & pain in the rt upper arm (pneumococcal site); pt exp no weakness or atrophy; pain is still persisting for more than 6 months;				Y					U	10/08/1992	11/05/1993	393	NONE	PVT	PVT	Ogen 1.25mg;	healthy	hx of menier's disease; hiatal hernia;	NA~ ()~~~In patient	930158301	1						1	Injection site pain; Muscle spasms; Myalgia	FLU3~PARKE-DAVIS~~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0066628	08/30/1994	WA	64.0	64		F	07/27/1993	pt recvd vax NOV91 & exp rash below pnu-imune site (from elbow to wrist); lesions (3cm x 2cm) were reddish w/whitish material on top; quite pruritic; rx: ATB; scaling lasted 2-3 mos; has scarring 2 yrs later; dx reactionary dermatitis;				Y					N	11/07/1991			NA	PUB	PUB	minipress, Valium;	NONE	pt has since recvd susbequent influenza immun w/no problems; pt has had high BP for the last 5 or 6 years; otherwise, in good physical hlth; no surgeries;	NA~ ()~~~In patient	930163201	1						1	Dermatitis exfoliative; Pruritus; Rash; Rash pustular	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~314914~1~IM~LA~PNEUMO (PNU-IMUNE)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0066634	08/30/1994	KS	43.0	43		M	09/20/1993	pt was hospitalized for fever-103 w/in 12 hrs p/vax & pt had a local react @ pnu-imune site rt arm described as erythematous; pt hospitalized;					Y				Y	09/17/1993	09/17/1993	0	unk	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	930199501	1						1	Injection site hypersensitivity; Pyrexia	FLUX~PFIZER\WYETH~4938140~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~356967~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0066639	08/30/1994	GA	66.0	66		F	10/06/1993	5OCT93 pt recvd vax & pt was receiving vax & became flushed & felt faint; MD administered 30cc DPH 5 mins later BP 160/82, pulse 80; pt sent home in approx 30 mins; pt recoverd; nurse reported pt very anxious & poss vasovagal react;				Y					Y	10/05/1993	10/05/1993	0	NONE	PVT	PVT	Premain, Provera, Calcium	Healthy	healthy	pt had prev problem following flu vax immun several yrs ago; MD gave flu vax;~ ()~~~In patient	930210201	1						1	Dizziness; Hypersensitivity; Syncope; Vasodilatation	FLU3~PARKE-DAVIS~005753P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~336942~1~IM~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0066644	08/30/1994	IA	89.0	89		F	10/25/1993	pt recvd vax & exp red cellulitis following vax; treated w/DPH/ice pack; pt recovered;									Y	10/11/1993	10/11/1993	0	NA	OTH	OTH	Ibuprofen, APAP	NONE	NONE	No h/o adverse event following prior vax; no history o family complaint;~ ()~~~In patient	930223001	1						1	Cellulitis; Vasodilatation	FLUX~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~330947~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0066651	08/30/1994	OH	49.0	49		F		pt recvd vax (1992) & was inadvertently re-vaxed on 29OCT93; also recvd flu vax; pt exp inject site react (PNU-IMUNE site) 9 x 5 cm which included swelling;				Y					N	10/28/1993	10/29/1993	1	NONE	PVT	PVT	NONE	healthy	hypertriglyceridemis	NA~ ()~~~In patient	930229301	1						1	Injection site oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~328909~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0066242	09/01/1994	IL				F	08/23/1994	pt recvd vax 27OCT93 & devel GBS & Bell's palsy; pt recovered & has returned to work;									Y	10/27/1993				PVT	PVT		unk		~ ()~~~In patient	894235001R	1						1	Facial palsy; Guillain-Barre syndrome	FLUX~PFIZER\WYETH~4938254~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0066250	09/01/1994	NY	13.0	13		M	08/29/1994	1OCT93 pt exp genl achiness & nauseated; 4OCT93 bloodwork showed irregular (high) counts; 8OCT93 bone pain (legs); 19NOV93 flu like sx (fever); 9DEC93 dx leukemia; pt exp runny nose, cough, resp infect; treated for bronchitis;			Y	Y	Y	200	Y		N	10/01/1993	10/01/1993	0	complete blood count done 4OCT93; CBC-WBC 11.5 w/43 lymphs, 4 blasts, 4 promyelocytes, 8 myelocytes, 3 metamyelocytes, 19 bands; HGB 10.4, HCT 30.4, MCV 101.3, platelet count 87,000; Uric acid 5.0, LDH 580, bilirubin 1.0; ALT 15;	PVT	PVT	FK506 Bactrim	NONE	liver transplant	~ ()~~~In patient		1						1	Acute myeloid leukaemia; Alopecia; Anaemia; Blood lactate dehydrogenase increased; Lung disorder; Red blood cell abnormality; Thrombocytopenia; White blood cell disorder; Acute myeloid leukaemia; Arthralgia; Bone pain; Depression; Leukocytosis; Monocytosis; Red blood cell abnormality; White blood cell disorder	FLU3~CONNAUGHT LABORATORIES~~UNK~SC A~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0048837	09/09/1994	CT	60.0	60		F	11/18/1993	pt recvd vax 6NOV91 & began feeling ill approx 1 wk p/vax 13NOV91; dx rheumatoid arthritis as of 3NOV93 pt is still requiring medical care;				Y				Y	N	11/06/1991	11/13/1991	7	x-rays & bone scan done, dx of rheumatoid arthritis;	PUB	PUB	NONE	NONE		NA~ ()~~~In patient	930249401	1						2	Malaise; Rheumatoid arthritis	FLU3~PFIZER\WYETH~312973~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~2	USA	Disabling	Influenza
0057830	09/09/1994	NY	52.0	52		F	11/12/1993	pt recvd vax & w/in 24 hrs devel a knot @ inject site; knot was in the muscle; pt is afebrile; initially had erythema @ the inject site which disappeared; however, knot remained p/4 wks;									Y	10/02/1993	10/03/1993	1	WBC 8.1; CPK 91;	PVT	PVT	Premarin	NONE		NONE~ ()~~~In patient	930243401	1						2	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~361923~UNK~IM~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~2	USA		Influenza
0066668	09/09/1994	CA				U	09/23/1993	1 of 8 pts who recvd vax exp pain @ inject site w/in 24 hrs of vax; pain lasted 1-5 days;									Y	09/01/1993	09/01/1993	0	NONE	PVT	PVT	UNK	unk	healthy;	NA~ ()~~~In patient	930203501	1						1	Injection site pain	FLU3~PFIZER\WYETH~361928~UNK~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066669	09/09/1994	CA				U	09/23/1993	1 of 8 pts who recvd vax exp pain @ inject site w/in 24 hrs of vax; pain lasted 1-5 days;									Y	09/01/1993	09/01/1993	0	NONE	PVT	PVT	NA	unk	healthy	NA~ ()~~~In patient	930203502	1						1	Injection site pain	FLU3~PFIZER\WYETH~361928~UNK~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066670	09/09/1994	CA				U	09/23/1993	1 of 8 pts who recvd vax exp pain @ inject site w/in 24 hrs of vax; pain lasted 1-5 days;									Y	09/01/1993	09/01/1993	0	NONE	PVT	PVT	NA	unk	healthy	NA~ ()~~~In patient	930203503	1						1	Injection site pain	FLU3~PFIZER\WYETH~361928~UNK~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066671	09/09/1994	CA				U	09/23/1993	1 of 8 pts who recvd vax exp pain @ inject site w/in 24 hrs of vax; pain lasted 1-5 days;									Y	09/01/1993	09/01/1993	0	NONE	PVT	PVT	NA	unk	healthy	NA~ ()~~~In patient	930203504	1						1	Injection site pain	FLU3~PFIZER\WYETH~361928~UNK~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066672	09/09/1994	CA				U	09/23/1993	1 of 8 pts who recvd flu vax exp pain @ inject site w/in 24 hrs of vax; pain lasted 1-5 days;									Y	09/01/1993	09/01/1993	0	NONE	PVT	PVT	NA	unk	healthy	NA~ ()~~~In patient	930203505	1						1	Injection site pain	FLU3~PFIZER\WYETH~361928~UNK~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066673	09/09/1994	CA				U	09/23/1993	1 of 8 pts recvd flu-imune exp pain @ inject site w/in 24 hrs of vax; pain lasted 1-5 days;									Y	09/01/1993	09/01/1993	0	NONE	PVT	PVT	NA	unk	healthy	NA~ ()~~~In patient	930203506	1						1	Injection site pain	FLU3~PFIZER\WYETH~361928~UNK~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066674	09/09/1994	CA				U	09/23/1993	1 of 8 pts who recvd flu-imune exp pain @ inject site w/in 24 hrs of vax; pain lasted 1-5 days;									Y	09/01/1993	09/01/1993	0	NONE	PVT	PVT	NA	unk	healthy	NA~ ()~~~In patient	930203507	1						1	Injection site pain	FLU3~PFIZER\WYETH~361928~UNK~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066675	09/09/1994	CA				U	09/23/1993	1 of 8 pts who recvd flu-imune exp pain @ inject site w/in 24 hrs of vax; pain lasted 1-5 days;									Y	09/01/1993	09/01/1993	0	NONE	PVT	PVT	NA	unk	healthy	NA~ ()~~~In patient	930203508	1						1	Injection site pain	FLU3~PFIZER\WYETH~361928~UNK~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066676	09/09/1994	GA	39.0	39		F	09/23/1993	1 of 5 pts recvd flu vax & devel inject site react w/in 24 hrs; reactions consisted of itching, erythema, induration, hot to touch & tenderness (the size of a silver dollar);									Y	09/01/1993	09/01/1993	0	NONE	PVT	PVT	UNK	NONE	healthy	unk~ ()~~~In patient	930204601	1						1	Injection site hypersensitivity; Injection site pain; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~359910~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066677	09/09/1994	GA	47.0	47		F	09/23/1993	1 of 5 pts recvd flu vax & devel inject site react w/in 24 hrs; reactions consisted of itching, erythema, induration, hot to touch & tenderness (the size of a silver dollar);									Y	09/01/1993	09/01/1993	0	NONE	PVT	PVT	unk	NONE	healthy	unk~ ()~~~In patient	930204602	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~359910~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066678	09/09/1994	GA	39.0	39		F	09/23/1993	1 of 5 pts recvd flu vax & devel inject site react w/in 24 hrs; reactions consisted of itching, erythema, induration, hot to touch & tenderness (the size of a silver dollar);									Y	09/01/1993	09/01/1993	0	NONE	PVT	PVT	UNK	NONE	healthy	UNK~ ()~~~In patient	930204603	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~359910~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066679	09/09/1994	GA	44.0	44		F	09/23/1993	1 of 5 pts recvd flu vax & devel inject site react w/in 24 hrs; reactions consisted of itching, erythema, induration, hot to touch & tenderness (the size of a silver dollar);									Y	09/01/1993	09/01/1993	0	NONE	PVT	PVT	unk	NONE	healthy	unk~ ()~~~In patient	930204604	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~359910~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066680	09/09/1994	GA				U	09/23/1993	1 of 5 pts recvd flu vax & devel inject site react w/in 24 hrs; reactions consisted of itching, erythema, induration, hot to touch & tenderness (the size of a silver dollar);									Y	09/01/1993	09/01/1993	0	NONE	PVT	PVT	unk	NONE	healthy	unk~ ()~~~In patient	930204605	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~359910~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066681	09/09/1994	TX				U	10/05/1993	1 of 6 pts exp inject site react , erythema, tenderness & itching w/in 24 hrs following vax; maximum size of react approx 7 cm long;									U				NONE	PVT	PVT	NA	NA	NA	NA~ ()~~~In patient	930210601	1						1	Injection site hypersensitivity; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~359909~UNK~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066682	09/09/1994	TX				U	10/05/1993	1 of 6 pts exp inject site rxn, erythema, tenderness & itching w/in 24 hrs following vax; maximum size of react-approx 7 cm long;									U				NONE	PVT	PVT	NA	NA	NA	NA~ ()~~~In patient	930210602	1						1	Injection site hypersensitivity; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~359909~UNK~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066683	09/09/1994	TX				U	10/05/1993	1 of 6 pts exp inject site react, erythema, tenderness & itching w/in 24 hrs following vax; maximum size of react-approx 7 CM long;									U				NONE	PVT	PVT	NA	NA	NA	NA~ ()~~~In patient	930210603	1						1	Injection site hypersensitivity; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~359909~UNK~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066684	09/09/1994	TX				U	10/05/1993	1 of 6 pts exp inject site react, erythema, tenderness & itching w/in 24 hrs following vax; maximum size of react approx 7 cm long;									U				NONE	PVT	PVT	NA	NA	NA	NA~ ()~~~In patient	930210604	1						1	Injection site hypersensitivity; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~359909~UNK~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066685	09/09/1994	TX				U	10/05/1993	1 of 6 pts exp inject site react, erythema, tenderness & itching w/in 24 hrs following vax; maximum size of react approx 7 cm long;									U				NONE	PVT	PVT	NA	NA	NA	NA~ ()~~~In patient	930210605	1						1	Injection site hypersensitivity; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~359909~UNK~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066686	09/09/1994	TX				U	10/05/1993	1 of 6 pts exp inject site react of erythema, tenderness & itching w/in 24 hrs following vax; maximum size or react-approx 7 cm long;									U				NONE	PVT	PVT	NA	NA	NA	NA~ ()~~~In patient	930210606	1						1	Injection site hypersensitivity; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~359909~UNK~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066687	09/09/1994	NJ	70.0			M	10/04/1993	consumer reported that durin 1990 flu season pt exp a fever for approx 1 wk postimmunization; no other sx were present; pt recovered; prior to this episode pt has been receiving flu vax every yr for the past 30 yrs w/no adverse events;				Y					Y				NA	PVT	PVT	NA		cardiac problem-unspecified;	~ ()~~~In patient	930212401	1						1	Pyrexia	FLU3~LEDERLE LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0066688	09/09/1994	PA	49.0	49		F	10/14/1993	1 of 4 pts vaxed from same lot exp and adverse event; pt exp inject site react - 10 cm in diameter (bruising, swelling, warm to touch, outer edges-red); rx warm compresses; also had h/a; 11NOV93 3 wks; later devel severe flu sx-bronchitis;									Y	10/11/1993	10/11/1993	0	no cultures	OTH	OTH	BP meds	healthy	hypertension;	NONE~ ()~~~In patient	930218101	1						1	Bronchitis; Drug ineffective; Ecchymosis; Headache; Infection; Influenza; Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~359910~1~IM~LL~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066689	09/09/1994	PA	48.0	48		F	10/14/1993	1 of 4 pts vaxed from the same lot exp an adverse event; pt exp h/a, & stomach cramping w/in 24 hrs following vax; treated w/APAP; pt recovered;									Y	10/08/1993	10/09/1993	1	no cutlures;	OTH	OTH	Asthma meds	healthy	cystic fibrosis	NONE~ ()~~~In patient	930218102	1						1	Abdominal pain; Headache	FLU3~PFIZER\WYETH~359910~UNK~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066690	09/09/1994	PA	45.0	45		F	10/14/1993	1 of 4 pts vaxed from the same lot exp an adverse event; pt exp flu-like sx (chills, h/a, malaise) w/in 24 hrs following vax; treated w/APAP & bed rest; pt recovered;									Y	10/08/1993	10/08/1993	0	NONE	OTH	OTH	NONE	healthy	resp allergies	NONE~ ()~~~In patient	930218103	1						1	Chills; Headache; Infection; Influenza; Malaise	FLU3~PFIZER\WYETH~359910~UNK~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066691	09/09/1994	PA	53.0	53		F	10/14/1993	1 of 4 pts vaxed from the same lot exp an adverse event; pt exp inject site react (10 cm diameter); react bright red, swelling & warm to touch; rx'd w/ASA; following day had sinus/cold sx;									Y	10/08/1993	10/09/1993	1	NONE	OTH	OTH	NA	NONE	NONE	NONE~ ()~~~In patient	930218104	1						1	Injection site hypersensitivity; Injection site oedema; Pharyngitis; Rhinitis; Vasodilatation	FLU3~PFIZER\WYETH~359910~UNK~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066692	09/09/1994	PA	46.0	46		F	10/20/1993	pt recvd vax 6OCT93 & next day both legs swollen & aching; sore throat, cough & fever developed; sx persisted for 3 days; @ time of report, pt still experienceing aches in legs, cough & fever on & off; called but not seen in ER;									Y	10/06/1993	10/07/1993	1	NONE	OTH	OTH	non-steroidal pain meds	NONE	breast cancer surgery JUL93;	NA~ ()~~~In patient	930223101	1						1	Cough; Myalgia; Oedema peripheral; Pharyngitis; Pyrexia	FLU3~PFIZER\WYETH~359908~UNK~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066693	09/09/1994	NY	28.0			F	11/02/1993	pt recvd vax 14OCT93 & approx 15 mins later pt lightheaded & hypotensive; Epi administered; pt transferred to ER: pt exp low BP, clammy, difficult to arouse;				Y					Y	10/14/1993	10/14/1993	0	NONE	PVT	PVT	NONE		carpal tunnel synd	NONE~ ()~~~In patient	930229101	1						1	Dizziness; Hyperhidrosis; Hypotension; Stupor	FLU3~PFIZER\WYETH~361923~1~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0066695	09/09/1994	MI	44.0	44		F	11/15/1993	w/in 2-3 days p/vax pt had shoulder pain; however, had no inject site react; neuro consult was obtained EMG done 10NOV93 dx lt ulnar neuropathy; pt lost grip in lt hand 15NOV				Y				Y	N	10/28/1993	11/01/1993	4	EMG lt ulner neuropathy 10NOV93; (pt is lt hand dominant); pos tunnel synd 18NOV93; c-spine nl;	PVT	OTH	NA	on re-exam pt recovered from bronchitis	h/o elevated enzymes; rt hip neurosis; hypothyroid; intermittant hematurai & alport's synd (congenital renal disease); non-drinker; poss dx carpal tunnel synd related to occupation or GBS;	NA~ ()~~~In patient	930244601	1						1	Condition aggravated; Myasthenic syndrome; Neuropathy; Pain	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Disabling	Influenza
0066696	09/09/1994	PA	41.0	41		F	11/17/1993	pt exp severe h/a, bronchial cough & excessive post-nasal drip 2 hrs p/vax; 8PM began to exp myalgias & arthralgias, nausea-never vomited; woke 1AM eyes were crusted, feet, hands, face swollen; called ER because of swelling;									Y	11/12/1993	11/12/1993	0	NONE	PVT	PVT	Seldane, ASA	healthy	sinus/environmental allergies, surgery/hysterectomy 1989;	NONE~ ()~~~In patient	930245301	1						1	Arthralgia; Cough; Face oedema; Headache; Myalgia; Nausea; Oedema peripheral; Rhinitis	FLU3~PFIZER\WYETH~~1~IM~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066697	09/09/1994	IL				F	11/18/1993	pt recvd vax & w/in several days devel rash on arms & legs; no other info available @ this time;									N	11/01/1993	11/18/1993	17	NA	PVT	PVT	unk	unk	unk	unk~ ()~~~In patient	930247601	1						1	Rash	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0066699	09/09/1994	MO	37.0	37		F	11/19/1993	pt recvd vax & 9NOV93 began exp severe pain in wrist & arms-shocking sensation/shooting pain; seen by MD on 11NOV93; pain worse now in legs & ankles; seen in ER 12NOV93; dx carpal tunnel synd; 19NOV93 seen by another neurologist;				Y					U	11/09/1993	11/09/1993	0	15NOV93 nerve conduction studies showed lt carpal tunnel; 19NOV93 seen by another neurologist for bilateral nerve conducter on feet, ankles, & legs results nl;	PVT	PVT	Depo-Provera	healthy		NONE~ ()~~~In patient	930252701	1						1	Arthralgia; Pain; Tenosynovitis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0066700	09/09/1994	WI	62.0	62		F	12/06/1993	pt recvd vax 6NOV93 & w/in 1 hr returned to office for inject site react consisting of erythema, induration & pruritus 3 cm in diameter; treated w/DPH; pt recovered; pt has recvd flu vax in the past w/no problems;				Y					Y	11/06/1993	11/06/1993	0	NONE	PVT	PVT	NONE	healthy		NONE~ ()~~~In patient	930255601	1						1	Injection site hypersensitivity; Injection site mass; Pruritus	FLU3~PFIZER\WYETH~359908~UNK~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0066250	09/15/1994	NY	13.0	13		M	09/09/1994	pt recvd vax & morning p/vax pt had nausea & felt crummy; pt had irregular shaped white blood cells, developing blast cells, & auer rods; 9OCT94 began c/o bone/joint pain; had low grade temp, earache, runny nose; exp wheezing, bronchitis;			Y		Y	237	Y		U	10/01/1993	10/01/1993	0	22NOV93 WBC 30,000; Neutrophils 14,000; Monocytes 8-9000; blast cells-22%; 30NOV93 white & red blood cells still abn;	PVT	OTH	FK506, Bactrim	NONE	chronic liver cirrhosis secondary to biliary atresia; no serious medical intervention until age 11; at age 12 on 26NOV92 had liver transplant w/antirejection med;	~ ()~~~In patient	CO5533	1						2	Acute myeloid leukaemia; Alopecia; Anaemia; Blood lactate dehydrogenase increased; Lung disorder; Red blood cell abnormality; Thrombocytopenia; White blood cell disorder; Acute myeloid leukaemia; Arthralgia; Bone pain; Depression; Leukocytosis; Monocytosis; Red blood cell abnormality; White blood cell disorder	FLU3~CONNAUGHT LABORATORIES~~UNK~SC A~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0066701	09/15/1994	AR				U	08/26/1994	pt recvd vax & 3 to 4 wks later pt devel transverse myelitis; It is assumed the pt was hospitalized;					Y				U					OTH	OTH	unk	unk	NONE	~ ()~~~In patient	894242001A	1						1	Asthenia; Myelitis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0066976	09/30/1994	NJ	64.0			M	09/28/1994	pt recvd vax;vascular purpura appeared in ankle;pt had febrile episodes, chills & sweats;skin biopsy revealed leukocytoclastic vasculitis;exacerbation of skin lesion;wt loss;septal cellulitis;erythematous sclerodermiform;fibrinoid necrosis;					Y				U	11/15/1992			march93 ESR = 50; HT = 25; moderate neutropenia [<2000/mm3];	OTH	OTH	calcium blocker;		hypertension;	~ ()~~~In patient	32365	1						1	Cellulitis; Leukopenia; Necrosis; Purpura; Red blood cell sedimentation rate increased; Vasculitis; Weight decreased	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0067092	10/03/1994	MO	29.0	29		F	09/30/1994	pt recvd vax & approx 6 hrs after vax, devel total body myalgia; lasted for 24 hrs;									Y	09/29/1994	09/29/1994	0		PVT	PVT		none;	none;	~ ()~~~In patient		1						1	Myalgia	FLU3~CONNAUGHT LABORATORIES~4F51133~5~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067106	10/05/1994	TX	50.0			F	10/03/1994	pt exp allerg react 2.75 hrs post vax; sx included SOB, itching, hives & red blotches;pt attended emergency clinic where passed out; tx DPH, EPI; PMD believes pt exp allerg rxn to ATB in vax.				Y					Y	09/27/1994	09/27/1994	0	NONE	PUB	PVT	Dyazide, Levothroid, Meclizine;	healthy	MD reports pt has a hx of sensitivity to Mycine	NA~ ()~~~In patient	ALI94211	1						1	Dyspnoea; Hypersensitivity; Pruritus; Rash maculo-papular; Syncope; Urticaria	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0067128	10/06/1994	MI	34.0	34		M	10/01/1994	pt recvd vax & had status epilepticus for 4 hrs & sz 25 SEP; t 102; to er, meds given; sleepy & postictal state; d/c 26sep94;					Y	2			Y	09/22/1994	09/24/1994	2	ct scan neg; blood, urine - spinal; fluid cultures neg;	PVT	PUB	navane tegretor dilantin;	none;	mental retardation; controlled sz disorder (last eepisode 2 yrs ago);	none;~ ()~~~In patient		1						1	Condition aggravated; Convulsion; Grand mal convulsion; Pyrexia; Somnolence; Stupor	FLU3~PARKE-DAVIS~00474P~1~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0067139	10/06/1994	TX	2.0	2	.5	M		pt recvd vax & immed started screaming & shaking; seen in MD ofc 2 hrs later; irritability & fever of 102.7; exam nl; dpt rxn ?										09/29/1994	09/29/1994	0		OTH	UNK			none;	~ ()~~~In patient		1						1	Agitation; Crying; Pyrexia; Tremor	DTP~LEDERLE LABORATORIES~350915~4~IM L~~DTP (TRI-IMMUNOL)~1|FLU3~MEDEVA PHARMA, LTD.~4F51113~1~IM L~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0060949	10/07/1994	CA				F	09/14/1994	pt recvd vax & devel serious illness which may result in permanent impairment;					Y			Y	N	09/22/1993				PVT	PVT				~ ()~~~In patient	894271004A	1						2	Arthralgia; Headache; Hypokinesia; Insomnia; Neck pain; Osteoarthritis; Pain; Tenosynovitis; Unevaluable event	FLUX~PFIZER\WYETH~4938186~1~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938186~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation,Disabling	Influenza
0067169	10/07/1994	FL	57.0	57		F	10/04/1994	pt recvd vax & devel guillain barre synd;					Y					09/16/1994	09/28/1994	12	none;	PVT	PVT		none;	diabetes mellitus, coronary insufficiency;	none;~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLU3~PFIZER\WYETH~494811~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~378979~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0067176	10/07/1994	OR	50.0	50		M	10/04/1994	pt recvd vax 3oct & devel swelling & erythema in genitals & welts on lt dorsal hand, larger one on RT biceps; tx w/ benadryl;									U	10/03/1994	10/03/1994	0		OTH	UNK		none;	none;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Oedema genital; Rash; Urticaria	FLU3~PFIZER\WYETH~4948040~5~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0067207	10/11/1994	FL	42.0	42		F	10/03/1994	pt recvd vax & had pain at inject site; red edema painful on LL; lymph node in neck enlarged, hot & painful 10mm; fever 99, aches: muscles & skin, felt sick,queasy,nausea;weakness;feverish; lasted 36 hrs;									Y	09/30/1994	09/30/1994	0	none;	PUB	PUB	none;	none;	multi allergies;	none;~ ()~~~In patient	FL94072	1						1	Asthenia; Injection site hypersensitivity; Injection site oedema; Lymphadenopathy; Malaise; Myalgia; Pain; Pyrexia	FLU3~PARKE-DAVIS~00294P~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1474W~1~IM~LL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0067209	10/11/1994	MS	59.0	59		F	10/05/1994	pt recvd vax & c/o redness, swelling & fever at inject site; tx w/ apap;									U	10/03/1994	10/03/1994	0	none;	PUB	UNK	none;	none;	no allergies;	~ ()~~~In patient	MS94050	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PARKE-DAVIS~00294P~2~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1474W~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0067241	10/11/1994	IL	0.2	0	.2	F	10/06/1994	pt recvd vax & devel hives; rash began 2 days after vax; headache; n on 30sep94;				Y					U	09/28/1994	09/30/1994	2		OTH	UNK	desogen;	none;	allergic, sulfa;	~ ()~~~In patient		1						1	Headache; Nausea; Rash; Urticaria	FLU3~PFIZER\WYETH~49M8048~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0067246	10/11/1994	CA	7.0	7		F	10/05/1994	pt recvd vax & devel swelling of eyelids; urticaria;									Y	09/29/1994	09/29/1994	0		PVT	PVT			angionerotic edema from augmenten, cerebral palsy;	~ ()~~~In patient		1						1	Face oedema; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51069~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067251	10/11/1994	FL	76.0	76		M	10/06/1994	pt recvd vax & loss strength in right hand; peripheral neurophathy rt upper extremity at flu shot inject site;									N	09/09/1994	09/15/1994	6	none;	PVT	PVT		none;	none;	~ ()~~~In patient		1						1	Myasthenic syndrome; Neuropathy	FLU3~PFIZER\WYETH~4948111~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~362967~UNK~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0067266	10/13/1994	MA	77.0			F	09/26/1994	pt recvd vax & 5 days later was admitted to hosp w/ thrombocytopenia manifested by hematuria & tarry stools;					Y	14			U	09/19/1994	09/24/1994	5	platelets 150000-350000/cumm nl range; pt's value 51,000; bone marrow biopsy: lymphoma;	PVT	PVT		malaise;	hypertension;	~ ()~~~In patient	894273001A	1						1	Haematuria; Melaena; Pseudo lymphoma; Thrombocytopenia	FLU3~PFIZER\WYETH~~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0067272	10/13/1994	TX	31.0	31		F	10/10/1994	pt recvd vax & had S.O.B; mild wheeze; throat tight & sensation of closing; to er, given epi; dph; steroids & other meds;				Y					Y	10/05/1994	10/05/1994	0	none;	PVT	PVT	PPD;	none;	pcn allergy;	~ ()~~~In patient		1						1	Asthma; Dyspnoea; Laryngospasm	FLU3~CONNAUGHT LABORATORIES~4F5105~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~4E61168~2~IM~~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0067278	10/13/1994	CA	0.2	0	.2	M	10/10/1994	pt recvd vax & was dizzy & sweaty;									Y	10/10/1994	10/10/1994	0		PVT	OTH	ventolin & intal; ppd; conn; lot #237611;	none;	none;	none;~ ()~~~In patient		1						1	Dizziness; Hyperhidrosis	FLU3~PARKE-DAVIS~01564P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0067282	10/13/1994	NM	72.0			M	10/05/1994	pt recvd vax & had sweats; tremors; body aches; weakness;									U	10/01/1994	10/02/1994	1		UNK	UNK	none;			~ ()~~~In patient		1						1	Asthenia; Hyperhidrosis; Myalgia; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0067285	10/13/1994	AZ	33.0	33		F	10/06/1994	pt recvd vax & had syncope & convuls lasting 2-3 mins;									Y	10/06/1994	10/06/1994	0		PVT	PVT			allergic to sulfa;	~ ()~~~In patient		1						1	Convulsion; Syncope	FLU3~PFIZER\WYETH~4948106~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0067309	10/14/1994	CA	62.0	62		F	10/10/1994	pt recvd vax & right arm felt tender & devel of fever & induration/erythema of inject area assoc w/ nausea; vomiting;									Y	10/08/1994	10/08/1994	0	none;	PVT	PVT		none;	none;	none;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Nausea; Pain; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51069~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~364983~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0067312	10/14/1994	TX	70.0	70		U		pt recvd vax & was tender & sore;									Y	09/30/1994	09/30/1994	0	none;	PVT	PVT		none;	osteoporosis, hyperthopic sub aortic stenosis, COPD;	~ ()~~~In patient		1						1	Myalgia; Pain	FLU3~MEDEVA PHARMA, LTD.~E2584HL~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0067316	10/14/1994	CA	81.0	81		M	10/06/1994	pt recvd vax & was vomiting; fever; diarrhea & weakness;									Y	09/26/1994	09/27/1994	1	none;	PVT	PVT		none	none;	none;~ ()~~~In patient		1						1	Asthenia; Diarrhoea; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51006~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067327	10/17/1994	OH	52.0	52		F	10/13/1994	pt recvd vax & devel tightness in throat; abdo pain; to er; broke out in rash & had uvular swelling; given epi;				Y					Y	10/06/1994	10/06/1994	0		PVT	PVT	premarin;	none;	allergy to bee stings;	none;~ ()~~~In patient	CO5591	1						1	Abdominal pain; Laryngospasm; Oedema; Rash; Abdominal pain; Laryngospasm; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51085~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~4F51085~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0067328	10/17/1994	NY	60.0	60		M	10/13/1994	pt recvd vax & was sweating; inc t 103; very fatigue & weak; atrial flutter; admitted to hosp;					Y	3			Y	10/05/1994	10/05/1994	0		PVT	UNK	b/p med, ecotrin ventolin, halcion;		heart disease: ventricular arrythmia w/palpitations; hypertension; hyperlipidemia; MI; CABG; COPD; NKMA;	~ ()~~~In patient	CO5598	1						1	Asthenia; Atrial flutter; Chest pain; Hyperhidrosis; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51158~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0067329	10/17/1994	NJ	52.0	51		F	10/13/1994	pt recvd vax & passed out; no pulse & also hives; pt was unconscious; eyes & arms & legs were swollen; admitted to hosp for 2 days;					Y	2			Y	10/07/1994	10/07/1994	0		PVT	OTH	asthmacort, delacone, premarin & provera;			~ ()~~~In patient	CO5601	1						1	Cardiovascular disorder; Coma; Face oedema; Oedema peripheral; Syncope; Urticaria; Anaphylactoid reaction; Dizziness; Syncope; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51133~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~4F51133~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0067330	10/17/1994	IL	29.0			M	10/13/1994	pt recvd vax & felt anxious; diaphoretic; nubness & tingling of extremities; chest tightness; disoriented; given meds; epi; to ER;				Y					Y	10/07/1994	10/07/1994	0		OTH	OTH	none;	none;	none;	none;~ ()~~~In patient	CO5603	1						1	Anxiety; Chest pain; Confusional state; Hyperhidrosis; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51023~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0067333	10/17/1994	CA	18.0	18		M	10/13/1994	pt recvd vax & exp heat related injuries during physical therapy run. during run; lost consciousness; pt had a rectal t of 104.9; admitted to hosp;				Y	Y	4			Y	09/22/1994	09/23/1994	1		MIL	MIL	Bicillin 22SEP94;	Mononucleosis;		~ ()~~~In patient	WAES94091064	1						1	Blood lactate dehydrogenase increased; Haematuria; Hyperbilirubinaemia; Pyrexia; Syncope; Tachycardia; Thinking abnormal; Thrombocytopenia	DT~UNKNOWN MANUFACTURER~~UNK~~~DT ADSORBED (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~SC~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0067349	10/17/1994	CA	81.0	81		M	10/12/1994	pt recvd vax & exp shoulder tenderness then could not lift arm; was shaking & had fever of 104; to er; tx w/ meds; admitted to hosp;				Y	Y	1			Y	10/07/1994	10/08/1994	1	x-ray shoulder;	PUB	PUB	diabinose; cardiazem;	none;	diabetes;	~ ()~~~In patient		1						1	Hypokinesia; Pain; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~4948120~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0067355	10/17/1994	MN	69.0	69		F	10/12/1994	pt recvd vax & devel swelling at inject site ? infect, eventually had excision of area; pt had high grade malignancy arising from site (merckel's cell tumor of skin);			Y	Y					U	10/01/1993				UNK	UNK				~ ()~~~In patient		1						1	Ecchymosis; Injection site oedema; Neoplasm malignant	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0067364	10/17/1994	NH	41.0	41		M	10/12/1994	pt recvd vax & had acute onset of bilat leg weakness; could not support his own weight; weakness; on exam could not elevate legs against gravity; sxs of weakness;				Y					Y	10/11/1994	10/11/1994	0	hypokalemia = 3.1 mmol/l; L-s spine x rays revealed no acute fx;	OTH	OTH	none;	none;	none;	~ ()~~~In patient		1						1	Asthenia; Hypokalaemia; Hypokinesia; Myasthenic syndrome	FLUX~UNKNOWN MANUFACTURER~~7+~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0067366	10/17/1994	IN	64.0	64		F	10/12/1994	pt recvd vax & upper arm became red & warm; tx w/ ice & DPH;				Y					Y	10/07/1994	10/08/1994	1		PVT	PVT		none;		~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~E2534HE~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~382958~1~IM A~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0067367	10/17/1994	VA	53.0	53		M	10/10/1994	pt recvd vax & arm was swollen; severe myalgia;				Y					Y	10/04/1994	10/07/1994	3	none;	OTH	PVT	none;	none;	govt;	~ ()~~~In patient		1						1	Myalgia; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~E2584KA~7+~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0067377	10/17/1994	WI	66.0	66		F	10/11/1994	pt recvd vax & had vomiting; stomach upset;									Y	10/05/1994	10/05/1994	0	none;	PVT	UNK	calan sr; ASH;	none;	none;	~ ()~~~In patient		1						1	Dyspepsia; Vomiting	FLU3~PARKE-DAVIS~00274P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0067381	10/17/1994	VA	60.0	60		M	10/11/1994	pt recvd vax & began feeling heavy breathing; chest tightness; dry cough followed by fever 100; chills; achiness; called MD;									Y	10/10/1994	10/10/1994	0	none;	OTH	OTH	on chemotherapy;	finished antibiotic course;	mult myeloma;	~ ()~~~In patient		1						1	Chest pain; Chills; Cough; Dyspnoea; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51025~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067383	10/17/1994	VA	47.0	47		F	10/13/1994	pt recvd vax & had inject site red & fevered;									Y	10/06/1994	10/07/1994	1	none;	PVT	PVT	none;	none;	none;	none;~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51141~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067384	10/17/1994	NY	78.0	78		M	10/11/1994	pt recvd vax & felt funny; feverish- tired; washed out & flu like;									N	10/06/1994	10/07/1994	1	none;	PVT	UNK		none;	stroke;	~ ()~~~In patient		1						1	Asthenia; Influenza; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0067416	10/19/1994	VA	26.0	26		F	10/12/1994	pt recvd vax & h/a, lightheadedness, nausea, pain at inject site w/in 15 mins; low grade t 99; hives neck, chest, back & cheeks; erythema; edema; inc color @ inject site; tx O2 by NC, epi and meds.									Y	10/11/1994	10/11/1994	0		OTH	PUB	none;	none;	none;	~ ()~~~In patient		1						1	Dizziness; Headache; Injection site hypersensitivity; Injection site oedema; Injection site pain; Nausea; Pyrexia; Urticaria	FLU3~PFIZER\WYETH~4948129~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0067442	10/20/1994	IN	73.0	73		F	10/11/1994	pt recvd vax & had local rxn immediately after vax; area raised & sl ecchymotic; area warm to touch;									Y	10/11/1994	10/11/1994	0	none;	PVT	PVT	hydrodiuril; calcium; k-lor powder;	none;	celiac; sprue; arthritis;	~ ()~~~In patient		1						1	Ecchymosis; Injection site mass; Vasodilatation	FLU3~PFIZER\WYETH~01564~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0067469	10/21/1994	MO	61.0	61		F	10/13/1994	pt recvd vax & had chest pain; stomach cramps & mild diarrhea;									Y	10/12/1994	10/13/1994	1	none;	PUB	PVT	premarin;	none;	antenial by pass in 1989;	~ ()~~~In patient	MO94072	1						1	Abdominal pain; Chest pain; Diarrhoea	FLU3~CONNAUGHT LABORATORIES~4F51160~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067473	10/21/1994	MO	63.0	63		F	10/13/1994	pt recvd vax & had severe headache & pain; stiffness in neck; called PMD;tx w/ ATB									Y	10/07/1994	10/08/1994	1	none;	PUB	PUB	had been on cephalexin p.o;	sinusitus;		~ ()~~~In patient	MO94076	1						1	Headache; Neck pain; Nuchal rigidity	FLU3~CONNAUGHT LABORATORIES~4F51160~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067474	10/21/1994	MO	62.0	61		F	10/13/1994	pt recvd vax & had chills; fever & sweating;									Y	10/07/1994	10/07/1994	0		PUB	PUB				~ ()~~~In patient	MO94113	1						1	Chills; Hyperhidrosis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51160~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067496	10/21/1994	VA	46.0	46		F	10/11/1994	pt recvd vax & had headache; pain in head; joints painful; chills; no appetite; weakness; redness; heat & soreness at inject site; shooting sharp pains;									U	10/07/1994	10/08/1994	1		PUB	PUB	thyroid medication;	none;	hypo thyroid; mold, dust allergy; no probs since allergy shots 1980's;	~ ()~~~In patient	VA94071	1						1	Anorexia; Arthralgia; Asthenia; Chills; Headache; Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51006~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~370944~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0067497	10/21/1994	PA	81.0	81		F	10/17/1994	urticaria; hypotension; acute tubular necrosis;			Y		Y	6			Y	10/13/1994			inc creat bun/dec output;	PVT	PVT	tasix; mytrin; lanoxin;	none;		~ ()~~~In patient		1						1	Blood creatinine increased; Blood urea increased; Hypotension; Oliguria; Renal tubular necrosis; Urticaria	FLU3~PARKE-DAVIS~00384P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation	Influenza
0067503	10/21/1994		64.0	64		M	09/28/1994	pt recvd vax & appeared w/ transient sx 48 hrs after vax, sx incl encephalopathy & ataxic gate;					Y					09/21/1994	09/23/1994	2	neurological tests performed; B work chem 7; EKG; chest x ray; telemetry; cat scan; carotid dopplers; ecchocardiogram;	UNK	UNK				in pt had ataxial encephalopathy after flu vax 10 yrs ago;~ ()~~~In patient		1						1	Coordination abnormal; Encephalopathy	FLU3~CONNAUGHT LABORATORIES~4F51074~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0067509	10/21/1994	OK	57.0	57		M	10/14/1994	c/o heavyness of head-no focal neuro sx; BP uncontrolled to 190/110 even w/meds;				Y					Y	10/12/1994	10/12/1994	0		PVT	PVT		NONE	HTN, mild obesity, inc cholesterol	NONE~ ()~~~In patient		1						1	Condition aggravated	FLU3~CONNAUGHT LABORATORIES~4F51006~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0536A~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0067517	10/21/1994	CA	6.0	5		F	10/11/1994	6OCT feel ill, h/a, fever, vomited, sore throat; 10OCT tired easily, cough, rales in lt lung; 13OCT afebrile, palyful, healthy on Amoxil for pneumonia since 10OCT94;									Y	10/05/1994	10/06/1994	1	NONE	PVT	PVT		NONE	Nothing	~ ()~~~In patient		1						1	Asthenia; Cough; Headache; Lung disorder; Pharyngitis; Pneumonia; Pyrexia; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E25046GC~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0067518	10/21/1994	MN	63.0	63		F	10/16/1994	nausea, chills, weakness, h/a; bedrest;									Y	09/22/1994	09/22/1994	0	NA	OTH	PVT	NA	NA	NA	NA~ ()~~~In patient		1						1	Asthenia; Chills; Headache; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0067520	10/21/1994	PA	20.0	20		F	10/13/1994	acute anaphylactic react w/in 5 mins of flu vax; needed EPI, 02, Kenalog & DPH to recover;									Y	10/05/1994	10/05/1994	0		PVT	PVT				~ ()~~~In patient		1						1	Anaphylactoid reaction	FLU3~CONNAUGHT LABORATORIES~4F51069~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067527	10/21/1994	PA	68.0	68		F	10/14/1994	pt recvd vax & devel macularpapular rash; pruritus;									U	10/03/1994	10/04/1994	1		PVT	UNK	disoxin; coumadin;	MVR;	NKDA;	not known;~ ()~~~In patient		1						1	Pruritus; Rash maculo-papular	FLU3~PFIZER\WYETH~4948109~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0067528	10/21/1994	VA	41.0	41		F	10/18/1994	pt recvd vax & had redness; swollen;									Y	10/13/1994	10/14/1994	1	none;	PVT	OTH	claritin, vitamins;	none;	allergies;	none in pt;~ ()~~~In patient		1						1	Oedema; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E2584HH~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0067530	10/21/1994	VA	25.0	25		F	10/18/1994	pt recvd vax & had headache; chills; fever; arm swollen; hot to touch; ached in arm;  tx w/APAP q 4 hrs til sx subsided;									Y	10/12/1994	10/12/1994	0	none;	OTH	PVT	apap;	none;	none;	sibling had allergy to pcn since birth;~ ()~~~In Sibling		1						1	Chills; Headache; Myalgia; Oedema peripheral; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51145~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~376970~UNK~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0067531	10/21/1994	VA	30.0	30		F	10/18/1994	pt recvd vax & had local rxn & pain; c/o of redness; inject site hard; hot/ cold chills; blurred vision; c/o nausea; diarrhea; ache all over;									Y	10/12/1994	10/13/1994	1	none;	OTH	PVT	apap; benadryl;	sinusitus;	none;	none;~ ()~~~In patient		1						1	Amblyopia; Chills; Diarrhoea; Injection site hypersensitivity; Injection site mass; Injection site pain; Myalgia; Nausea	FLU3~CONNAUGHT LABORATORIES~4F51145~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~376970~UNK~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0067534	10/24/1994	FL	58.0	58		F	10/18/1994	pt recvd vax & exp burning sensation in arm, x 5 mins; inject site was red, swollen & hot to touch; pain radiating from site up arm & down to elbow; itchy over upper body area; slept poorly; felt feverish; shoulder ached; edema;				Y						10/14/1994	10/15/1994	1		PUB	PUB	Estorderm	NONE	NONE	~ ()~~~In patient	FL94074	1						1	Dysphagia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Insomnia; Pharyngitis; Pruritus; Pyrexia	FLU3~PARKE-DAVIS~00294P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0067535	10/24/1994	FL	43.0	43		F	10/18/1994	double vision lasting 15 mins-started 30 mins p/inject; sore throat, h/a, muscle aches lasting 48 hrs p/inject;									Y	10/14/1994	10/14/1994	0	NONE	PUB	PUB	Estoderm patch;	NONE	Indocin PCN	~ ()~~~In patient	FL94075	1						1	Diplopia; Headache; Myalgia; Pharyngitis	FLU3~PARKE-DAVIS~00294P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0067536	10/24/1994	FL	46.0	46		F	10/18/1994	Friday noc started feeling achey; 230 Saturday morning-woke up w/myalgia, fever 101, chills, tenderness @ inject site w/swelling @ inject site; cont until 18OCT94; saw MD on 17OCT94 dx react to vax;				Y					Y	10/14/1994	10/14/1994	0		PUB	PUB		NONE	allergies-mold, dust; asthma;	~ ()~~~In patient	FL94076	1						1	Chills; Injection site oedema; Injection site pain; Myalgia; Pyrexia	FLU3~PARKE-DAVIS~00294P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0067539	10/24/1994	MS	63.0	63		F	10/18/1994	pneumonia vax given pt went to work gave a perm & did a hair cut noticed arm swelling, red area, red streaks down arm; bothered pt all noc;				Y					Y	10/17/1994	10/17/1994	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MS94054	1						1	Oedema peripheral; Skin striae; Vasodilatation	FLU3~PARKE-DAVIS~00194P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1474W~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0067556	10/24/1994	UT				F	10/07/1994	pt recvd vax & described breaking out in hives immed after vax; tx w/ DPH;									N	10/06/1994	10/06/1994	0	none;	OTH	PVT	none;	none;	allergies to pollens, sulfa, ceftin;	nephew extremely allergic to eggs;~ ()~~~In patient	UT941821	1						1	Urticaria	FLU3~PFIZER\WYETH~4948031~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0067559	10/24/1994	IL	73.0			M	10/04/1994	pt w/ epilepsy tx w/ dilantin recvd vax & had grand mal sz; to hosp;					Y				Y				GGT 252; therapeutic dilantin level, hep a,b,c neg;	PVT	UNK	dilantin;		epilepsy; paroxysnol tachycaul; rml pneumonia;prior sz disorder	~ ()~~~In patient		1						1	Condition aggravated; Gamma-glutamyltransferase increased; Grand mal convulsion	FLU3~CONNAUGHT LABORATORIES~4F51079~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0067566	10/24/1994	PA	73.0	73		F	10/18/1994	pt recvd vax & devel hives in lt antecubital space,to ER for eval; tx DPH & Solumedrol;				Y					Y	10/04/1994	10/04/1994	0	none;	PUB	PUB	carafate synthroid; prozac;	none;	pt claims she gets rash once in a while w/ her nerves; ulcers;	~ ()~~~In patient	PA9505	1						1	Condition aggravated; Injection site hypersensitivity	FLU3~PFIZER\WYETH~4948066~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0067568	10/24/1994	SC	66.0	66		F	10/17/1994	approx 3-4 hrs p/vax pt had red, warm rash on face, neck & both arms w/swelling of face, eyelids, & throat; pts given DPH; 4 days p/vax pt seen in ER w/same sx;				Y					Y	10/06/1994	10/06/1994	0	PE by ER MD:	PUB	PVT	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Face oedema; Laryngospasm; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4948111~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0067574	10/24/1994	DE	76.0	76		F	10/12/1994	pt approx 3-4 minutes p/shot became acutely dizzy, pale, diaphoretic				Y					N	09/22/1994	09/22/1994	0		PVT	PVT	NONE	NONE	Arthritis	~ ()~~~In patient		1						1	Dizziness; Hyperhidrosis; Pallor	FLU3~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0067576	10/24/1994	TX	72.0	71		F	10/18/1994	red, warm, painful indurated area @influenza site; smaller react @ pneumonax site;				Y					Y	10/11/1994	10/12/1994	1		PVT	PVT	Ecotrin	NONE	NKA	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51113~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~~UNK~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0067577	10/24/1994	TX	42.0	42		F	10/18/1994	devel 9x8 cm indurated red area @ inject site rx w/ ice Advil;				Y					Y	08/30/1994	09/01/1994	2		PVT	PVT	aovcon TOfranil, APAP	NONE	allergy to codeine	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~4F51113~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0067580	10/24/1994	TX	71.0	71		F	10/18/1994	devel red, warm, not temp swelling @ inject site;				Y					Y	09/22/1994	09/23/1994	1		PVT	PVT	Premarin, Lanoxin, Norpace, Provera, Tranxene	NONE	NKA; Arrhythemia, menopause	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51113~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~~1~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0067582	10/24/1994	FL	47.0	47		F	10/19/1994	lt deltoid area hard indurated area, erythematosis w/petechial hemmorhages; pain radiated into lt shoulder & neck;									Y	10/18/1994	10/19/1994	1		PUB	UNK		NONE	NONE	~ ()~~~In patient		1						1	Injection site haemorrhage; Injection site hypersensitivity; Injection site mass; Neck pain; Pain; Petechiae	FLU3~CONNAUGHT LABORATORIES~4F51074~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067586	10/24/1994	WI	46.0	46		F	10/19/1994	fever, chills, generalized aching & fatigue;									U	09/30/1994	10/12/1994	12		OTH	OTH	Theo-dur; Lodine	NONE	asthma, allergic to PCN, ASA, Keflex, Volatore	~ ()~~~In patient		1						1	Asthenia; Chills; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4948121~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0067587	10/24/1994	NE	50.0	50		F	10/14/1994	pt recvd vax 330Pm later same noc 830 noticed water blisters on face;									Y	10/05/1994	10/05/1994	0	NONE	OTH	OTH	unk	NONE	allergic to cats & cat hair	~ ()~~~In patient		1						1	Dermatitis bullous	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0067588	10/24/1994	CT	31.0	31		F	10/19/1994	h/a, chills, low grade fever (99.0), nausea, vomiting, muscle aches; given APAP remained on bedrest x 3 hrs, felt better; 20OCT93: reports afebrile, overall feels better,sl nauseous;									Y	10/18/1994	10/19/1994	1		OTH	PVT		NONE	allergies: amoxicillin, E-Mycin, PCn	~ ()~~~In patient		1						1	Chills; Headache; Myalgia; Nausea; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51158~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067590	10/24/1994	IL	66.0	66		M	10/21/1994	signs of heavy cold-sore throat, running nose, dry cough, some chest congestion;									N	10/14/1994	10/14/1994	0	NONE	OTH	PUB	mepoprolol, Allopurinol, ASA	NONE	arteriosclerotic heart disease	NONE~ ()~~~In patient		1						1	Cough; Lung disorder; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0067594	10/24/1994	OH	72.0	71		F	10/20/1994	17OCT94 flu shot rt deltoid pneumovax lt deltoid 18OCt93 sore, red, warm lt deltoid below inject site 10 x 8 cm area;									Y	10/17/1994	10/18/1994	1	NA	PVT	PVT	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4948100~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~384959~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0067599	10/24/1994	IL				F	10/18/1994	devel hot red lump @ inject site followed by a rash in axilla (bil) that looked like broken blood vessels-called own MD; OK now, but rash is scaling;									Y	10/14/1994	10/14/1994	0		PVT	PVT		NONE	deneis egg allergy	~ ()~~~In patient		1						1	Dermatitis exfoliative; Injection site hypersensitivity; Injection site mass; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067600	10/24/1994	IL				F	10/18/1994	next day devel flu sx, h/a, vomiting stayed in bed 15OCT; better on 16OCt;									Y					PVT	PVT		NONE	allergies NONE known-hx migraines	~ ()~~~In patient		1						1	Headache; Influenza; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51132~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067601	10/24/1994	MI	63.0	63		F	10/14/1994	red eyes w/pruritus; feverish feeling w/o documented fever; generalized weakness;									Y	10/12/1994	10/13/1994	1		PVT	PVT	DIlantin, Procardia, glucorex, Niacin	HTN, DM hx RA	HTN, DM, CVA, RA, sz disorder, sick sinus synd;	pt exp similiar sxs approx 8 yrs ago w/flu vax;~ ()~~~In patient		1						1	Asthenia; Conjunctivitis; Pruritus; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51141~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067602	10/24/1994	TX	72.0	72		F	10/14/1994	redness & swelling @ inject site from shoulder to elbow, red, hot, swollen;									Y	09/23/1994	09/24/1994	1	NONE	PVT	PVT				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51113~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~~2~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0067603	10/24/1994	TX	52.0	52		M	10/18/1994	had congestion-cough, sinuses congested sx started 1wk later; dx bronchitis-ATB, antihistimines;									Y	10/04/1994	10/12/1994	8	NONE	PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Bronchitis; Cough; Rhinitis	FLU3~PFIZER\WYETH~4948117~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0067619	10/25/1994	OH	1.1	1	.1	F	10/18/1994	pt recvd vax & ran fever of 102.5; to MD; dx w/ virus; broke out w/ measles; had cough; still weak; lethargic; poor appetite;				Y					U	10/10/1994	10/10/1994	0		PVT	PVT	fluoride drops;	none;	none;	pt had sl fever at 9 mo w/ 2 dose of dtp;~ ()~~~In patient		1						1	Anorexia; Asthenia; Cough; Drug ineffective; Infection; Pyrexia; Somnolence	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~1~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0067620	10/25/1994	NJ	47.0	47		F	10/10/1994	reporter states pt recvd vax in lt arm, devel pain in lt arm/shoulder, couldn't move neck; went to PMD, tx w/ meds, improved w/ tx.				Y					Y	10/07/1994	10/07/1994	0	none	PVT	OTH	betagan opth gets diamox;		glaucoma; peptic ulcer;	~ ()~~~In patient		1						1	Nuchal rigidity; Pain	FLU3~PARKE-DAVIS~00574P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0067621	10/25/1994	CA	41.0	41		F	10/21/1994	pt recvd vax & c/o of heart pounding; rapid pulse; flushing ringing in ears; numbness in fingers bilat sense of doom; to er;  c/o redness; warmth; induration size of lemon; tenderness in LA;				Y					Y	09/27/1994	09/27/1994	0	EKG in er; no abn;	OTH	UNK	none;	none;	none;	none;~ ()~~0.00~Patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Palpitations; Paraesthesia; Tachycardia; Tinnitus; Vasodilatation	FLU3~PFIZER\WYETH~4948112695~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0067627	10/25/1994	LA	61.0	61		F	10/19/1994	pt recvd vax & had purple discoloration ( bruise on rt arm);  center firm & more sore; sensitive to touch;									U	10/18/1994	10/18/1994	0		OTH	PVT	none;	none;	none;	~ ()~~~In patient		1						1	Ecchymosis; Injection site pain; Skin discolouration	FLU3~CONNAUGHT LABORATORIES~4157025~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067628	10/25/1994	CA	8.0	8		F	10/17/1994	pt recvd vax & had redness of skin at inject site;									Y	09/30/1994	10/01/1994	1	none;	PVT	PVT		none;	reactive airway disease;	~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~4G51074~6~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067629	10/25/1994	FL	65.0	65		F	10/21/1994	pt recvd vax & devel rash in area of vax; edema of Lt arm muscle; itching in lt arm; given DPH									Y	10/18/1994	10/18/1994	0		PVT	PVT		none;	pcn allergy; asthma;	none;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PARKE-DAVIS~01664P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0067631	10/25/1994	NJ	67.0	67		U		pt recvd vax & c/o headache;									Y	10/07/1994	10/07/1994	0	none;	PVT	OTH	micronase;	none;	diabetes mellitus;	~ ()~~~In patient		1						1	Headache	FLU3~PARKE-DAVIS~00574P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0067632	10/25/1994	CA	39.0	39		M	10/20/1994	pt recvd vax &  exp dry Rt eye; unable to close the Rt eye,facial asymmetry; dx R bell's palsy;									U	10/18/1994	10/19/1994	1	none;	PVT	UNK		none;	none;	none;~ ()~~~In patient		1						1	Dry eye; Facial palsy	FLU3~PARKE-DAVIS~01864P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0067634	10/25/1994	SC	30.0	30		F	10/21/1994	pt recvd vax & c/o urticaria; to clinic; tx w/ DPH & meds;									Y	10/20/1994	10/20/1994	0	none;	PVT	PVT	tapizol;	head cold;	graves disease;	~ ()~~~In patient		1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51025~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067635	10/25/1994	NJ				F	10/10/1994	pt recvd vax & c/o of headache;									Y	10/07/1994	10/07/1994	0	none;	PVT	OTH	procardia;	none;	hypertension;	~ ()~~~In patient		1						1	Headache	FLU3~PARKE-DAVIS~00574P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0067636	10/25/1994	CA	83.0	83		F	10/20/1994	pt recvd vax & had vertigo;									Y	10/14/1994	10/17/1994	3	none;	PVT	PVT	inderal; procardia; aspirin; duazide;	none;	hypertension; hairy cell leukemia;	~ ()~~~In patient		1						1	Vertigo	FLU3~CONNAUGHT LABORATORIES~4F51160~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067637	10/25/1994	CA	79.0	79		F	10/20/1994	pt recvd vax & had vertigo;									Y	10/14/1994	10/16/1994	2	none;	PVT	PVT	sinemet; inderal; isordit; lasix; k+; hytrin;	none;	hypertension, parkinson's, ASCVD /angina;	~ ()~~~In patient		1						1	Vertigo	FLU3~CONNAUGHT LABORATORIES~4F51160~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068653	10/25/1994	OH	23.0	23		F	08/23/1994	pt recvd vax; shakiness, trembling, hot flashes, rapid heartbeat, room spinning, n, no v; happened on & off until 7pm; arm very sore; hard; swollen; hot to touch; 11jan94 tired, limited range  of motion Lt arm x 5 days, knot at site;				Y					Y	10/21/1993	10/21/1993	0		PVT	PVT	ortho-cyclen;	none;	no allergy hx; antihistamine cause hyper feeling;	none;~ ()~~~In patient	CO5061	1						1	Asthenia; Dizziness; Hypokinesia; Injection site mass; Myalgia; Tachycardia; Tremor; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41132~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0056636	10/26/1994	VA	66.0	66		M	08/23/1994	sweating, dizzy, blacked out, skin rash; taken to ER w/SOB & wheezing; not life threating; discharged p/6-7 hrs; treated w/EPi & DPH; No change in usual habits; has had vax in the past;				Y					Y	10/11/1993	10/12/1993	1		PUB	PUB	heart medication	NONE	heart condition	NO~ ()~~~In patient	CO5023	1						2	Asthma; Dizziness; Dyspnoea; Hyperhidrosis; Rash; Syncope	FLU3~CONNAUGHT LABORATORIES~3F41035~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0056778	10/26/1994	OK	22.0	22		F	09/21/1994	pt recvd vax; arm swelled, had fever & very sore; formed knot the size of baseball;									Y	09/21/1993	08/23/1994	336		PVT	PVT		none;		~ ()~~~In patient	CO5053	1						2	Myalgia; Oedema peripheral; Pyrexia; Skin nodule	FLU3~CONNAUGHT LABORATORIES~3F41027~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0056818	10/26/1994	OK	41.0	40		F	08/23/1994	pt recvd vax; red, swollen & itchy at inject site									Y	09/22/1993	09/22/1993	0		PVT	PVT	ogen;	none;	none;	none;~ ()~~~In patient	CO5052	1						2	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~CONNAUGHT LABORATORIES~3F41027~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0056838	10/26/1994	TX	49.0	49		F	08/23/1994	blah feeling on 16OCt, then on 17OCT had low grade fever & rash @ inject site which spread to palm; also has stomach cramping & bad itching; vaccine in the past; 29DEC93 on 19OCT93 rash spread to hands, scalp & trunk; persisted x 3 days;									Y	10/15/1993	10/16/1993	1		PUB	PVT	Equetac, allergy medication	seasonal allergies	allergy to sulfa	NO~ ()~~~In patient	CO5039	1						2	Abdominal pain; Injection site hypersensitivity; Malaise; Pruritus; Pyrexia; Rash; Skin discolouration	FLU3~CONNAUGHT LABORATORIES~3F41009~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|TD~LEDERLE LABORATORIES~334901~4~IM~RA~TD ADSORBED (NO BRAND NAME)~2	USA		Influenza
0056943	10/26/1994	VA	84.0	84		F	08/23/1994	pt recvd vax; devel generalized urticarial rash w/ facial swelling; no resp problems; 10jan94 resolved after 1 wk; no tx;				Y					Y	10/07/1993	10/07/1993	0		OTH	OTH	lasix, methyldopa, darvocet, k dur; ibuprofen; probenicid, ferrous sulfate, triamcinslone;		no past hx of allergy;	~ ()~~~In patient	CO5049	1						2	Face oedema; Urticaria	FLU3~CONNAUGHT LABORATORIES~3F41010~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0057003	10/26/1994	OH	75.0	75		F	08/23/1994	pt recvd vax; devel severe muscle aches, t of 101, n, mild dehydration hypotension; no local rxn; 14dec93 f/u: tx w/ compazine & resolved;									Y	10/11/1993	10/11/1993	0		UNK	UNK	pepcid, plaquenil;	rhinorhhea, sinusitis vs allergy.	allergy to pcn;	none;~ ()~~~In patient	CO5058	1						2	Dehydration; Hypotension; Myalgia; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41141~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0057242	10/26/1994	PA	1.7	1	.7	F	08/23/1994	pt recvd vax; angiodema, red rash, blotchy all over from head to toe, including rt lower thigh at inject site; has had all vax for age w/out problem;				Y					Y	10/21/1993	10/21/1993	0		UNK	UNK	bactrim;	URI being tx w/ bactrim;	downs synd;	none;~ ()~~~In patient	CO5059	1						2	Angioneurotic oedema; Injection site hypersensitivity; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~3F41123~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0057416	10/26/1994	TX	69.0	69		F	08/23/1994	erythematous, papular, pruritic skin eruption;				Y					Y	10/29/1993	10/30/1993	1		PVT	PVT	Zestril, Premarin,Tenormin;	NONE	allergic to PCN	~ ()~~~In patient	CO5212	1						2	Pruritus; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~3F41016~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0057437	10/26/1994	TX	68.0	68		F	08/23/1994	pruritic skin react, general									Y	10/28/1993	10/29/1993	1		PVT	PVT	Zantac, Ativan	NONE	NONE	~ ()~~~In patient	CO5213	1						2	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~3F41016~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0057438	10/26/1994	NH	44.0	44		F	08/23/1994	achy & sore then myalgia w/fever of 101-104 on 6NOV93; As of 8NOV93 cont w/sx; plus has cough w/phlegm production;									Y	11/04/1993	11/05/1993	1		PVT	PVT	NONE	NONE	NONE	No~ ()~~~In patient	CO5117	1						2	Cough; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41027~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0057476	10/26/1994	NM	31.0	31		F	08/23/1994	pt recvd vax; papular rash, very itchy & dry on ventral aspects of forearm, wrist & up; resolving 22oct93;									Y	10/14/1993	10/16/1993	2		UNK	UNK	none;		none known;	~ ()~~~In patient	CO5082	1						2	Dry skin; Pruritus; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~3F41172~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0057477	10/26/1994	NM	57.0	57		F	08/23/1994	pt recvd vax; transient itchy macular papular rash on chin, cheeks & dorsal of forearms;									Y	10/15/1993	10/15/1993	0		UNK	UNK			allergy to PPD, pcn all :caine: injections;	~ ()~~~In patient	CO5081	1						2	Pruritus; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~3F41172~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0057650	10/26/1994	NY	70.0	70		M	08/23/1994	pt recvd vax; pain behind ears, then facial paralysis; cont still as of 10oct93; seeing a neurologist; no tx taken;				Y					N	10/28/1993	11/29/1993	32		UNK	UNK				~ ()~~~In patient	CO5098	1						2	Ear pain; Facial palsy	FLU3~CONNAUGHT LABORATORIES~3F41124~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0057933	10/26/1994	MI	70.0	70		F	08/23/1994	severe chills, diarrhea, severe fatigue, site dark red, hard, no appetite for 4 days; saw FP & BP was high; known hypertensive; was adm to hosp progressive care on 21OCT93 d/c 24OCT93; 3NOV93 still not feeling well; site blistered & scabbed					Y	3			Y	10/04/1993	10/05/1993	1		PUB	OTH	Procardia 30 mg, Lozol 2.5mg; Estrogen patch	NONE	HTN	No~ ()~~~In patient	CO5105	1						2	Anorexia; Asthenia; Chills; Condition aggravated; Diarrhoea; Electrolyte imbalance; Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~3F41142~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~UNKNOWN MANUFACTURER~~1~IM~LA~PNEUMO (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0058155	10/26/1994	CO	29.0	29		M	08/23/1994	petechial rash lt forearm, some numbness;									Y	12/03/1993	12/03/1993	0		PVT	UNK	NONE			~ ()~~~In patient	CO5193	1						2	Paraesthesia; Petechiae	FLU3~CONNAUGHT LABORATORIES~3F41032~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0058183	10/26/1994	ME	38.0	38		F	08/23/1994	twitching in arm w/in hrs of vax; devel twitching in both arm & legs 7-8days p/vax;@ 10days had tingling which kept pt awake @ noc;saw neurologist on 30NOV93, reflexes now fine, but since evening felt weaker;				Y					U	11/18/1993	11/18/1993	0		PVT	OTH				~ ()~~~In patient	CO5180	1						2	Asthenia; Muscle twitching; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0059118	10/26/1994	NJ	57.0	57		F	08/23/1994	immed local rxn of SC wheal; no systemic rxn; 20JAN94 f/u: treated w/DPH x 2-3 days; resolved;									Y	11/16/1993	11/16/1993	0		UNK	UNK	NONE	NONE	laryngeal CA; emphysema	~ ()~~~In patient	CO5157	1						2	Injection site mass; Injection site oedema; Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~3F41132~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~3F41132~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0060618	10/26/1994	ID	45.0	45		M	08/23/1994	awoke trembling & arm involuntarily moving about;lasted 5mins but was severe enough to consider calling 911;NOS x/inj site redness about 10cent size w/some necrosis;17NOV93 referred to MD;pt recovered									Y	11/11/1993	11/15/1993	4		OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	CO5158	1						2	Dermatitis exfoliative; Injection site hypersensitivity; Tremor; Injection site hypersensitivity; Injection site necrosis; Movement disorder; Tremor	FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~3F41027~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0067644	10/26/1994	MN	60.0	60		F	10/20/1994	some soreness, hard lump, red area-hot temp; severe black & blue;				Y					N	10/10/1994	10/10/1994	0		OTH	UNK	NONE	NONE		~ ()~~~In patient		1						1	Ecchymosis; Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0067645	10/26/1994	NJ	6.0	6		M	10/22/1994	comples febrile seizure 12 hrs p/vax; seen in ER given DIlantin; hx of agenesis corpus callosum, global developmental delay, bilat mastoidectomy, sz disorder;				Y					Y	10/21/1994	10/22/1994	1	CBC benign/dilantin level subtherapeutic	PVT	PVT	Dilantin	NONE	agenesis corpus callosum/developmental delay/sz disorder	NA~ ()~~~In patient		1						1	Condition aggravated; Febrile convulsion	FLU3~CONNAUGHT LABORATORIES~4F51010~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0067648	10/26/1994	NJ	33.0	33		M	10/18/1994	w/in 8 hrs employee stated came down w/a fever between 102 & 104, severe body aches, weakness x 2 days;									Y	10/13/1994	10/13/1994	0		PUB	OTH	Denied	denied	sulfa	~ ()~~~In patient		1						1	Asthenia; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4948037~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068609	10/26/1994	OH				F	08/23/1994	pt recvd vax; exp unk type of rxn; pt is seeing neurologist for sxs;				Y					U	09/01/1992				UNK	UNK				~ ()~~~In patient	CO4944	1						1	Unevaluable event	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068610	10/26/1994	NV	36.0	36		F	08/23/1994	pt recvd vax;  devel blotchy rash on face, hot & red, some swelling; also, achy, malaise, irritable; now has cold/sinus sxs w/ stuffiness; 18oct93 f/u: recovered;									Y	09/13/1993	09/13/1993	0		PVT	PVT	none;	none;	allergy to fertilizer, not eggs;	none;~ ()~~~In patient	CO4975	1						1	Agitation; Malaise; Myalgia; Oedema; Pharyngitis; Rash maculo-papular; Rhinitis; Sinusitis	FLU3~CONNAUGHT LABORATORIES~3F41114~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068611	10/26/1994	TX	60.0			F	08/23/1994	pt recvd vax; 3x2 local rxn;									U					UNK	UNK				~ ()~~~In patient	CO4980	1						1	Injection site reaction	FLU3~CONNAUGHT LABORATORIES~3F41118~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068612	10/26/1994	CA	52.0	52		F	08/23/1994	pt recvd vax; devel fever of 103 in 12 hrs; pain in joints; arthralgia, malaise; had vax every w/out a problem;recovered;									Y	09/27/1993	09/27/1993	0		PVT	PVT	corgard; amitriptyline; synthroid; dalmane; meprobamate; PRN;	none;	allergic to pcn, sulfa; conditions as tx w/ meds listed;	none;~ ()~~~In patient	CO4988	1						1	Arthralgia; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41125~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068613	10/26/1994	CA				M	08/23/1994	pt recvd vax;  devel fever & arthralgia, w/ malaise; 2 rpts from same provider;									U	09/28/1993	09/28/1993	0		UNK	UNK				~ ()~~~In patient	CO4989	1						1	Arthralgia; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41125~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068614	10/26/1994	IN	35.0	35		F	08/23/1994	pt recvd vax; exp shaky chills; bad h/a, n for 24 hrs;									Y	09/29/1993	09/30/1993	1		UNK	UNK	none;	none;	nka;	~ ()~~~In patient	CO4993	1						1	Chills; Headache; Nausea	FLU3~CONNAUGHT LABORATORIES~3F41016~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068615	10/26/1994	TX	31.0	30		F	08/23/1994	pt recvd vax; had red, indurated area 29x16mm;									U	09/30/1993	10/01/1993	1		PUB	UNK	estrogen injects;	none;	nka;	none;~ ()~~~In patient	CO4997	1						1	Skin nodule; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41009~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068616	10/26/1994	CA	4.0	4		U	08/23/1994	pt recvd vax; exp extreme swelling of lt leg w/ a 2 inc in circumference of leg;				Y					Y	09/29/1993	09/30/1993	1		PVT	UNK	none;	none;	hx of asthma;	none;~ ()~~~In patient	CO4998	1						1	Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~3F41007~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068617	10/26/1994	NY	21.0			F	08/23/1994	pt recvd vax; devel urticaria on face & abdo w/ itching and burning at site; no resp sxs; tx in er w/ DPH & resolved;				Y					Y	10/01/1993	10/02/1993	1		MIL	MIL				~ ()~~~In patient	CO5000	1						1	Injection site pain; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~3J41147~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068618	10/26/1994	IL	77.0	77		M	08/23/1994	pt recvd vax; devel diarrhea & hypothermia of 92; 2dec93 no response to request for more information;									U	09/28/1993	10/01/1993	3		UNK	UNK	dilantin; phenobarb; darvocet; lydex gel; procardia; hytrin; tagaaamet; urocholine;		sz dis; hypertension; gi bleeding; prostate problems; arthritis;	~ ()~~~In patient	CO5001	1						1	Diarrhoea; Hypothermia	FLU3~CONNAUGHT LABORATORIES~3F41118~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068619	10/26/1994	OH	28.0	28		F	08/23/1994	uncontrollable shaking & fever of 102, back pain, rash on back w/aches all over body; prev flu inject w/o problem; 2DEC93 No response to request for recovery status;				Y					Y	09/30/1993	10/01/1993	1		MIL	MIL	NONE	NONE	no allergy history	~ ()~~~In patient	CO5002	1						1	Back pain; Myalgia; Pyrexia; Rash; Tremor	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068620	10/26/1994	TX	33.0	33		F	08/23/1994	possible fever, not measured, felt bad; sore arm 2 1/2 indurated, erythematous area above & below inject site;									U	10/04/1993	10/05/1993	1		PUB	UNK	Birth control pill, Oxybutynine	NONE	No history of allergy	NONE~ ()~~~In patient	CO5003	1						1	Injection site hypersensitivity; Injection site mass; Malaise; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41009~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068621	10/26/1994	OH	68.0	68		F	08/23/1994	reddened, sl swollen area @ inject site, sl tired; took APAP for sx;									Y	10/06/1993	10/07/1993	1		PVT	PVT	NONE	NONE	no hx of allergy	NONE~ ()~~~In patient	CO5004	1						1	Asthenia; Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068622	10/26/1994	PA	26.0	26		F	08/23/1994	pounding h/a, diarrhea, stiff neck, local reaction on the noc of inject; all resolved by next morning x/small blisters @ site w/redness;									Y	10/07/1993	10/07/1993	0		PVT	PVT	Birth control pills, Erythromycin, Bactrim, Doxycycline	urinary tract infect-taking ATB	NONE	NO~ ()~~~In patient	CO5005	1						1	Diarrhoea; Headache; Injection site hypersensitivity; Injection site reaction; Nuchal rigidity	FLU3~CONNAUGHT LABORATORIES~3F41010~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068623	10/26/1994	OH	24.0	24		F	08/23/1994	blotches, gingivitis, ulcerations in mouth & genitals;									U	10/04/1993	10/06/1993	2		UNK	UNK	Ventalin		known asthmatic	~ ()~~~In patient	CO5008	1						1	Gingivitis; Mouth ulceration; Rash maculo-papular; Skin ulcer	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068624	10/26/1994	AR	29.0	29		F	08/23/1994	Tingling of fingers tips of lt hand; spread up to elbow, also nose & lips w/numbness of lips; h/a; pt recovered in 30 mins;									Y	10/12/1993	10/12/1993	0		PUB	OTH		NONE	NONE	No~ ()~~~In patient	CO5009	1						1	Headache; Paraesthesia; Paraesthesia oral	FLU3~CONNAUGHT LABORATORIES~3F41032~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068625	10/26/1994	IN	65.0			F	08/23/1994	angioedema under the eyes 3 days p/vax; No other sx;				Y					Y	10/07/1993	10/10/1993	3		PVT	OTH				~ ()~~~In patient	CO5011	1						1	Angioneurotic oedema	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~~UNK~~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0068626	10/26/1994	CA	27.0	27		F	08/23/1994	hot, red, silver dollar sized local react; gone in 2 days; then on 10OCT, woke w/lump 4 long by 3-4 wide; hard, size of a golf ball w/marble sized fluid sac; went to ER for tests; all neg; 22DEC93 f/u large claviclar node on lt side;				Y					Y	10/05/1993	10/05/1993	0		PVT	OTH		NONE	NONE	No~ ()~~~In patient	CO5014	1						1	Injection site hypersensitivity; Injection site mass; Lymphadenopathy; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41016~2~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068627	10/26/1994	MO	52.0	52		F	08/23/1994	local react of 4.5cm which is red, hot to touch & itchy; t98.9; 29DEC93 react appeared 12 hrs p/dose & persisted x 1 wk; treated w/DPH & ice pack;									Y	10/13/1993	10/14/1993	1		PUB	OTH	Robaxin, Reglan, Inderal, Estrogen, APAP#3;	NONE	allergic to iodine, Macrodantin, Donnatal, Augmentin	No~ ()~~~In patient	CO5016	1						1	Injection site hypersensitivity; Pruritus; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3J41146~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068628	10/26/1994	AL	65.0			F	08/23/1994	cutaneous bright red flushing over various parts of body; no other sx; tx w/DPH which relieved sx for 4-6hr; reoccurred & took DPH again w/complete resolution									Y	10/13/1993	10/13/1993	0		OTH	UNK	DPH	recent hosp admission for SVT	hypertension; NKA	~ ()~~~In patient	CO5018	1						1	Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068629	10/26/1994	CT	55.0	54		M	08/23/1994	difficulty breathing; awoke around 1230AM; was up to about 5AM; has happened in the past but takes Theodur & it ususally resolves; lasted longer than usual; As of 15OCT93 PM resolved just very tired from being up all noc;									Y	10/14/1993	10/15/1993	1		OTH	UNK	Theodur, Lasix, Zantec, Librax	NONE	asthma since age 5; allergy to ragweed & pollen also	No~ ()~~~In patient	CO5021	1						1	Asthenia; Condition aggravated; Dyspnoea; Insomnia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068631	10/26/1994	CA	56.0	55		F	08/23/1994	lymphadenopathy-golf ball size-in lt axilla; 2DEC93 no response to f/u request;				Y					U	10/12/1993	10/13/1993	1		PVT	PVT	Premarin	NONE	NKA	No~ ()~~~In patient	CO5025	1						1	Lymphadenopathy	FLU3~CONNAUGHT LABORATORIES~3F41003~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068632	10/26/1994	SC				U	08/23/1994	shoulder & elbow pain since inject; 2DEC93 No response to request for more info;				Y					N	10/05/1993	10/05/1993	0		OTH	OTH				~ ()~~~In patient	CO5026	1						1	Arthralgia; Pain	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068633	10/26/1994	SC				F	08/23/1994	pain @ site, but mostly in joint; 2DEC93 no response to f/u request;									U	10/13/1993	10/15/1993	2		UNK	UNK				~ ()~~~In patient	CO5027	1						1	Arthralgia; Injection site pain	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068634	10/26/1994	SC				U	08/23/1994	thoart closing; went to ER & was treated w/DPH; 2DEC93 no response to f/u request;				Y					Y					UNK	UNK				~ ()~~~In patient	CO5028	1						1	Laryngospasm	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068635	10/26/1994	PA	67.0	67		F	08/23/1994	2 1/2 inflamed, hot area 3cm below site of flu infect; started about 10AM, by 1PM c/o nausea, chills, weakness & aching;									Y	09/23/1993	09/24/1993	1		PVT	OTH	NONE	NONE	allergic to sulfonamides, hx of osteoarthritis, PVD, NIDDM	~ ()~~~In patient	CO5037	1						1	Asthenia; Chills; Injection site inflammation; Myalgia; Nausea; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41125~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~314912~1~SC~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0068636	10/26/1994	PA	86.0	86		F	08/23/1994	2 1/2 daimeter red, inflamed, hot area several cms below inject site on lt upper arm;									Y	09/21/1993	09/22/1993	1		PVT	OTH	NONE	NONE	allergic to PCN, hx ASCUD, CHF, HTN, hypercholesterimia	No~ ()~~~In patient	CO5038	1						1	Injection site hypersensitivity; Injection site inflammation; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41125~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068638	10/26/1994	MI	45.0	45		F	08/23/1994	anaphylatic react, not described; to ER 20 mins p/inject on 8OCT93 w/tightness of chest, sensation of throat closing; tx w/DPH, Solu Medrol, Proventil inhaler; referred to allergist;			Y	Y					Y	10/08/1993	10/08/1993	0		UNK	UNK	Premarin, Thyroid Med	NONE	NKA	No~ ()~~~In patient	CO5041	1						1	Anaphylactoid reaction; Chest pain; Laryngospasm	FLU3~CONNAUGHT LABORATORIES~3F41124~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0068639	10/26/1994	VA	40.0	40		M	08/23/1994	hives, tightness in chest & swelling in throat; 2DEC93 no response to f/u request;									Y	10/19/1993	10/19/1993	0		UNK	UNK				~ ()~~~In patient	CO5042	1						1	Chest pain; Laryngospasm; Urticaria	FLU3~CONNAUGHT LABORATORIES~3F41033~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068640	10/26/1994	VA	29.0	29		F	08/23/1994	facial redness for 1 noc, then resolved; 14DEC93 f/u also had facial itch & was wheezy, resolved;									Y	10/19/1993	10/19/1993	0		OTH	OTH	Theodur, Breathaire	NONE	ashtma	No~ ()~~~In patient	CO5043	1						1	Asthma; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41028~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068641	10/26/1994	VA	36.0	36		F	08/23/1994	generalized red rash w/intense itching; took DPH & resolved; 14DEC93 f/u itching & rash reoccurred x 1 wk; relieved more w/Vistoril;									Y	10/19/1993	10/19/1993	0		OTH	OTH	NONE	NONE	mold, dust, pollen & Tylox	No~ ()~~~In patient	CO5044	1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~3F41028~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068642	10/26/1994	MD	42.0	42		F	08/23/1994	pt recvd vax 19OCT93 & devel generalized pruritus, but no obvious urticarial lesions; no evidence of swelling or throat tightness;				Y					Y	10/19/1993				OTH	OTH	HCTE< Pepsid, entex-LA	NONE	allergic rhinitis	pt exp rash & swelling p/flu vax in 1990;~ ()~~~In patient	CO5045	1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~3F41124~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068643	10/26/1994	LA	30.0	30		F	08/23/1994	Lightheaded & dizzy; 14DEC94 f/u chills w/sl temp inc & SOB; given Epi; monitored v/s for 1hr; fever dec & BP returned to nl;									Y	10/21/1993	10/21/1993	0		OTH	PUB	NONE	NONE	NONE	~ ()~~~In patient	CO5046	1						1	Cardiovascular disorder; Chills; Dizziness; Dyspnoea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41028~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068644	10/26/1994	LA	24.0	24		F		lightheaded, dizzy, now wheezing, tightness of chest or throat; local react of hives; treated w/Epi & resolved in 30 mins; 14DEC93 f/u lightheadedness, chills & fever, myalgia which occurred w/in 15 mins of inject;									Y	10/21/1993	10/21/1993	0		OTH	PUB	NONE	NONE	NONE	~ ()~~~In patient	CO5047	1						1	Asthma; Chest pain; Chills; Dizziness; Injection site hypersensitivity; Laryngospasm; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41028~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068645	10/26/1994	IL	64.0	63		F	08/23/1994	pt recvd vax; devel low grade fever w/ chills;									Y	10/13/1993	10/14/1993	1		PUB	PUB	antihistamine;		allergies & sinus problems;	~ ()~~~In patient	CO5048	1						1	Chills; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41114~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068649	10/26/1994	CA	63.0	63		F	08/23/1994	pt recvd vax; exp profound muscle weakness w/ low grade & elevated WBC = 13,000; URI w/ sore throat & t of 100; cont w/ muscles weakness as of 22oct93; 2dec93 no response to f/u request;									U	10/08/1993	10/14/1993	6		UNK	UNK				~ ()~~~In patient	CO5055	1						1	Leukocytosis; Myasthenic syndrome; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068650	10/26/1994	OH	46.0	46		M	08/23/1994	pt recvd vax; devel fever of 101, achiness, fatigue; back to work on 22oct but still feel feverish & tired;				Y					Y	10/21/1993	10/21/1993	0		OTH	OTH				~ ()~~~In patient	CO5057	1						1	Asthenia; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41035~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068654	10/26/1994	NY	46.0	46		M	08/23/1994	pt recvd vax; bad h/a behind eyes, numbness in cheeks until next day & then gradually subsided; local rxn; tx w/ DPH & sent home; woke up 21oct93 w/ a thundering headache; 22oct93 sl h/a; site hyperemic, warm to touch. EKG nl 20oct93;									Y	10/20/1993	10/20/1993	0		OTH	OTH	none;		allergy to cats, deer, hay; hodgkins disease in remission;	in pt, devel h/a & cold last year w/ flu vax;~ ()~~~In patient	CO5062	1						1	Headache; Injection site reaction; Paraesthesia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41016~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068655	10/26/1994	TN				F	08/23/1994	pt recvd vax; hives, swelling, lost consciousness 8 hrs after inject; seen in er; 20jan94 no response to f/u request;				Y					Y	10/15/1993	10/15/1993	0		UNK	UNK				~ ()~~~In patient	CO5064	1						1	Oedema; Syncope; Urticaria	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068656	10/26/1994	UT	45.0	45		F	08/23/1994	pt recvd vax; fever of 103 w/ aching;									U	10/25/1993	10/25/1993	0		UNK	UNK	none;		allergy to pcn, sulfa, codeine;	~ ()~~~In patient	CO5070	1						1	Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41028~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068657	10/26/1994	KS	31.0	31		F	08/23/1994	pt recvd vax; exp weakness in arm difficulty lifting & doing usual activities; pain also, but not too severe; 17dec93 no response to f/u request;									U	10/18/1993	10/18/1993	0		UNK	UNK	none;		nka;	~ ()~~~In patient	CO5075	1						1	Hypokinesia; Myasthenic syndrome; Pain	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068658	10/26/1994	TN	37.0			F	08/23/1994	pt recvd vax; fever, chills, sweating, h/a, aching of muscles & joints, weakness & n; (no vomiting); started 6 hrs after inject & lasted 48 hrs; 25jan94 tx w/ apap;									Y					OTH	PVT	none;	none;	allergies: dust, grass;	~ ()~~~In patient	CO5076	1						1	Arthralgia; Asthenia; Chills; Headache; Hyperhidrosis; Myalgia; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41033~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068659	10/26/1994	TN	27.0	27		F	08/23/1994	pt recvd vax; red, swollen, warm to touch at inject site; 25jan94 tx w/ DPH; resolved 18oct93;									Y	10/14/1993	10/14/1993	0		OTH	PVT	none;	none;	allergies: hayfever; allergic to eggs prior to age 2;	sensitivity rxn as infant;~ ()~~~In patient	CO5077	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41033~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068660	10/26/1994	TN	53.0	53		F	08/23/1994	pt recvd vax; devel fever of 102, chills, h/a; 25jan94 had n, v, diarrhea, weakness w/in 24 hrs of vax lasting for 2 days; tx w/ apap;									Y	10/26/1993	10/27/1993	1		OTH	PVT	none;	none;	none;	codeine-nausea; dental anesthetic-blisters in mouth;~ ()~~~In patient	CO5078	1						1	Asthenia; Chills; Diarrhoea; Headache; Nausea; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~3F41033~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068661	10/26/1994	OH	49.0	49		F	08/23/1994	pt recvd vax; devel giant hives, rash on face & anxiety; large local rxn; tx w/ DPH & methylprednesolone; hives resolved but still had blotchy rash after 2 hrs;									Y	10/26/1993	10/26/1993	0		UNK	UNK	premarin, lopressor, seldane d;		known allergies to pollen, sulfa, pcn, codeine & iodine;	~ ()~~~In patient	CO5079	1						1	Anxiety; Injection site reaction; Rash; Rash maculo-papular; Urticaria	FLU3~CONNAUGHT LABORATORIES~3F41008~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068662	10/26/1994	PA	44.0	44		F	08/23/1994	pt recvd vax; devel bloody diarrhea; 6jan94 flu like sxs, fever, malaise, abdo pain; stool culture neg;									Y	10/26/1993	10/26/1993	0		OTH	PVT	none;	none;	connective tissue disease;	~ ()~~~In patient	CO5080	1						1	Abdominal pain; Diarrhoea haemorrhagic; Influenza; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068665	10/26/1994	NC	40.0			F	08/23/1994	pt recvd vax; blister at inject site;									U					UNK	UNK				~ ()~~~In patient	CO5083	1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068666	10/26/1994	GA	62.0	62		F	08/23/1994	pt recvd vax; erythema multiforme; diffuse pruritic rash on trunk & neck; bullous w/ desquamazation; 10jan94 referred to allergist;									Y	10/20/1993	10/21/1993	1		PVT	PVT	synthroid, hormone injections;	none;	past hx of steroid induced psychosis; allergy to other meds;	pt had flu vax in 1990 w/out problem;~ ()~~~In patient	CO5085	1						1	Dermatitis bullous; Dermatitis exfoliative; Erythema multiforme; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~3F41027~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068667	10/26/1994	WA	40.0			F	08/23/1994	pt recvd vax; 1 diam red, itchy & hot to touch at inject site									U	10/25/1993	10/25/1993	0		UNK	UNK				~ ()~~~In patient	CO5086	1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068668	10/26/1994	OH	43.0	43		M	08/23/1994	pt recvd vax; hives 12 hrs after vax; tx w/ DPH;				Y					Y	10/27/1993	10/27/1993	0		UNK	UNK	none;	none;	none;	none;~ ()~~~In patient	CO5087	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~3F41118~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068669	10/26/1994	NC	31.0	31		U	08/23/1994	pt recvd vax; 3cm axillary lymph node on lt side; no oth sxs; 2feb94 recvd returned form; no info avail;									U	10/15/1993	10/16/1993	1		UNK	UNK		none;	allergy to morphine;	in pt, had axillary lymph node swelling;~ ()~~~In patient	CO5088	1						1	Lymphadenopathy	FLU3~CONNAUGHT LABORATORIES~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068670	10/26/1994	OR	68.0			F	08/23/1994	pt recvd vax; devel huge hives; responded to depromedrol & po predinsone;									Y					UNK	UNK	synalar;	none;	none;	none;~ ()~~~In patient	CO5091	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~3F41125~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068672	10/26/1994	NH	36.0	36		U	08/23/1994	pt recvd vax; fever, muscle, body pains, weakness the eve of inject; tx w/ apap;									Y	11/01/1993	11/01/1993	0		UNK	UNK	none;	none;	none;	none;~ ()~~~In patient	CO5099	1						1	Asthenia; Myasthenic syndrome; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41132~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068673	10/26/1994	MD	75.0	75		M	08/23/1994	finger turned purple, then white w/in minutes of inject; No other sx; vax in the past w/o problem;									Y	11/02/1993	11/02/1993	0		UNK	UNK	several			~ ()~~~In patient	CO5100	1						1	Skin discolouration	FLU3~CONNAUGHT LABORATORIES~3F41114~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068674	10/26/1994	OH	40.0			F	08/23/1994	acute chest congestion, h/a, gritty, runny eyes, fever & chills; by morning was clear;									Y	10/28/1993	10/28/1993	0		PVT	PVT	NONE	NONE	hayfever	No~ ()~~~In patient	CO5103	1						1	Chills; Headache; Lacrimal disorder; Lung disorder; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41028~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068675	10/26/1994	NJ	59.0			F	08/23/1994	red, hot to touch area 3 in circumfrence;									Y					PVT	PVT	NONE	NONE		~ ()~~~In patient	CO5104	1						1	Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41118~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068677	10/26/1994	TX	35.0	35		F	08/23/1994	vertigo, mental confusion, severe h/a, feeling tired; 10JAN94 pain lt arm & leg, neck & lower back 1 hr p/inject; blurred vision; resolved p/24-48 hrs;									Y	11/03/1993	11/03/1993	0		OTH	OTH	NONE	NONE	allergic to Keflex	Yes-GI sx p/last yrs flu vax~ ()~~~In patient	CO5106	1						1	Amblyopia; Asthenia; Back pain; Confusional state; Headache; Neck pain; Pain; Vertigo	FLU3~CONNAUGHT LABORATORIES~3F41016~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068678	10/26/1994	TX	50.0	50		F	08/23/1994	severe h/a, vertigo, mental confusion & fatigued; 10JAN94 sx resolved 36-48hrs;				Y					Y	11/03/1993	11/03/1993	0		OTH	OTH	Ogen	NONE	allergy Minocin-gets dizzy & nauseous	No~ ()~~~In patient	CO5107	1						1	Asthenia; Confusional state; Headache; Vertigo	FLU3~CONNAUGHT LABORATORIES~3F41016~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068679	10/26/1994	IL	50.0	50		F	08/23/1994	lightheadedness, nausea, lethargic & dizziness; pain in the back of neck, elevated BP; was seen in ER: 17DEC93 No response to f/u request;				Y					U	11/03/1993	11/04/1993	1		UNK	UNK	Inderal		history of migraine	~ ()~~~In patient	CO5108	1						1	Dizziness; Hypertension; Nausea; Neck pain; Somnolence	FLU3~CONNAUGHT LABORATORIES~3F41010~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068680	10/26/1994	VA	12.0	12		F	08/23/1994	flushing, h/a, resp flu sx, blood sugar-out of control;				Y					U	10/29/1993	10/29/1993	0		UNK	UNK			diabetes	~ ()~~~In patient	CO5111	1						1	Headache; Hyperglycaemia; Influenza; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068681	10/26/1994	NC	84.0	84		F	08/23/1994	joint aching, hot flashes, diffuse myalgia; liver test really elevated; 2NOV93 devel noc sweats, anorexia & aching all over; 10JAN94 dx acute leukemia-MD feels sx were not related to vax;				Y					U	10/12/1993	10/13/1993	1		UNK	UNK	ASA, Premarin		poss lymphoma in 1983-no reoccurence	~ ()~~~In patient	CO5112	1						1	Acute leukaemia; Anorexia; Arthralgia; Hepatic function abnormal; Hyperhidrosis; Myalgia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41008~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068682	10/26/1994	DC	36.0	36		M	08/23/1994	local swelling, arm pain, paresthesia, weakness & dizziness;									Y	10/20/1993	10/20/1993	0		MIL	MIL	Questran		hypercholesterolemia	similar rxn in 1990-none in 91 or 92;~ ()~~~In patient	CO5113	1						1	Asthenia; Dizziness; Injection site oedema; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~3J41146~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068683	10/26/1994	CA	55.0	55		F	08/23/1994	swelling, erythema about the size of silver dollar w/itching @ inject site; 22DEC93 f/u called pt to request more info about provider; 30DEC93 spoke w/pt would not give info about provider; states devel flu on 22NOV93 & pneumonia 29NOV93;				Y					U	11/03/1993	11/08/1993	5		UNK	UNK			Graves disease	~ ()~~~In patient	CO5115	1						1	Drug ineffective; Infection; Influenza; Injection site hypersensitivity; Injection site oedema; Pneumonia; Pruritus	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068684	10/26/1994	UT	32.0	32		M	08/23/1994	hands went numb w/tingling; no other sx; severe enough that could not drive; works in the power plant; As of 8NOV93 still has some tingling; 25JAN94 has recovered;				Y					Y	11/05/1993	11/05/1993	0		OTH	OTH	NONE	NONE	NKA	NO~ ()~~~In patient	CO5116	1						1	Paraesthesia	FLU3~CONNAUGHT LABORATORIES~3F41028~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068686	10/26/1994	NE	45.0	45		F	08/23/1994	whites of eyes turned red, then pupils turned white as reported by pt; eye color light blue/gray; also had thick white mucous which cleared w/warm water; pain in ankle, sharp pain in rib cage on inspiration & pain in arm; muscle spasms;				Y					Y	09/17/1993	09/17/1993	0		OTH	OTH	Nordate Birth Control	NONE	NONE	No~ ()~~~In patient	CO5119	1						1	Arthralgia; Chest pain; Condition aggravated; Conjunctivitis; Eye disorder; Galactorrhoea; Hypertonia; Pain	FLU3~CONNAUGHT LABORATORIES~3F41171~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068687	10/26/1994	CA	44.0	44		M	08/23/1994	chills, fever between 99.5-100.5, arthralgias, felt unwell; also general malaise; took APAP; 15NOV93 phone in pt called again cont to have sx; encouraged again to seek med advice; 16NOV93 pt stated MD dx walking pneumonia;				Y					U	11/08/1993	11/08/1993	0		PVT	PVT	NONE		minor hayfever	~ ()~~~In patient	CO5120	1						1	Arthralgia; Chills; Malaise; Pneumonia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068688	10/26/1994	NY				F	08/23/1994	dizzy & unsteady; 28DEC93 No response to f/u request;									U					UNK	UNK				~ ()~~~In patient	CO5121	1						1	Dizziness; Gait disturbance	FLU3~CONNAUGHT LABORATORIES~3F41029~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068689	10/26/1994	NY				M	08/23/1994	dizzy; 28DEC94 No response to f/u request;									U					UNK	UNK				~ ()~~~In patient	CO5122	1						1	Dizziness	FLU3~CONNAUGHT LABORATORIES~3F41029~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068690	10/26/1994	NY	71.0	71		F	08/23/1994	severe chills 5 hrs p/vax; recvd vax early Oct; intermittent cheeks flushing w/cold extremities & profound weakness & fatigue; cont w/fatigue as of 1NOV93; has seen cardiologist & internist; All blood studies nl but still profound fatigue;				Y					N	10/12/1993	10/12/1993	0		PVT	PVT	NONE	NONE	NONE	NO~ ()~~~In patient	CO5093	1						1	Asthenia; Chills; Peripheral vascular disorder; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41008~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068691	10/26/1994	AR				M	08/23/1994	possible cellulitis; adm to hosp; responded to ATB; 28DEC94 no response to f/u request;					Y				U					UNK	UNK				~ ()~~~In patient	CO5094	1						1	Cellulitis	FLU3~CONNAUGHT LABORATORIES~3F41028~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0068692	10/26/1994	AR				F	08/23/1994	possible cellulitis									U					UNK	UNK				~ ()~~~In patient	CO5095	1						1	Cellulitis	FLU3~CONNAUGHT LABORATORIES~3F41028~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068693	10/26/1994	AR				F	08/23/1994	possible cellulitis									U					UNK	UNK				~ ()~~~In patient	CO5096	1						1	Cellulitis	FLU3~CONNAUGHT LABORATORIES~3F41028~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068694	10/26/1994	OH	48.0	48		F	08/23/1994	erythema, swelling from deltoid elbow; also had chills;									Y	10/27/1993	10/27/1993	0		UNK	UNK				~ ()~~~In patient	CO5097	1						1	Chills; Oedema peripheral; Rash	FLU3~CONNAUGHT LABORATORIES~3F41008~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068695	10/26/1994	PA	33.0	33		F	08/23/1994	numbness in legs, electric shocks in spine, lymph node swelling, fever 103, sl h/a; 11NOV93 only has sl h/a;									Y	11/08/1993	11/08/1993	0		PVT	PVT	NONE	NONE	NONE	allergy (unk type) to MRII~ ()~~~In patient	CO5124	1						1	Headache; Lymphadenopathy; Paraesthesia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41123~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1	USA		Influenza
0068696	10/26/1994	CT	36.0	36		F	08/23/1994	h/a, stomach ache, high fever w/difficulty standing up or eating; presumed recovered; 1DEC93 no response to f/u request;									Y	10/27/1993	10/28/1993	1		UNK	UNK				~ ()~~~In patient	CO5125	1						1	Abdominal pain; Anorexia; Headache; Hypokinesia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068697	10/26/1994	ME				U	08/23/1994	herpes simples reoccurance in an active duty person; 2 of 6 rpts from same provider; 9DE93 No response to f/u request;									U					MIL	MIL				~ ()~~~In patient	CO5127	1						1	Condition aggravated; Herpes simplex	FLU3~CONNAUGHT LABORATORIES~3J41019~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068698	10/26/1994	ME				U	08/23/1994	herpes simples reoccurance in active duty person; 3 of 6 rpts from same provider; 9DEC93 No response to f/u request;									U					MIL	MIL				~ ()~~~In patient	CO5128	1						1	Condition aggravated; Herpes simplex	FLU3~CONNAUGHT LABORATORIES~3J41019~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068699	10/26/1994	ME				U	08/23/1994	brachial plexis neuropathy which resembled herpes zoster w/o the lesions; 4 of 6 rpt from same provider; 9DEC93 No response to f/u request;									U					MIL	MIL				~ ()~~~In patient	CO5129	1						1	Herpes zoster; Neuropathy	FLU3~CONNAUGHT LABORATORIES~3J41019~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068700	10/26/1994	ME				U	08/23/1994	pityriasis rosea; 5 of 6 rpts from same provider; 9DEC93 No response to f/u request;									U					MIL	MIL				~ ()~~~In patient	CO5130	1						1	Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~3J41019~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068701	10/26/1994	ME				U	08/23/1994	Herpes zoster reoccurance; 6 of 6 rpts from same provider; 9DEC93 No response to f/u request;									U					MIL	MIL				~ ()~~~In patient	CO5131	1						1	Condition aggravated; Herpes zoster	FLU3~CONNAUGHT LABORATORIES~3J41019~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068702	10/26/1994	MD	68.0	68		F	08/23/1994	peticial outbreak on lower extremities; had eczematous rash on upper chest when given vax; recent course of ATB for URI; poss assoc of URI & Henock-Scholein purpura;				Y					Y	11/03/1993	11/08/1993	5		PVT	PVT	Antibiotic for recent URI	Eczematous rash, recent URI	NKA	~ ()~~~In patient	CO5135	1						1	Petechiae; Purpura	FLU3~CONNAUGHT LABORATORIES~3F41028~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068703	10/26/1994	NY				F	08/23/1994	pt recvd vax; severe itching; 28dec93 no response to f/u request;				Y					U	11/07/1993	11/12/1993	5		UNK	UNK				~ ()~~~In patient	CO5136	1						1	Pruritus	FLU3~CONNAUGHT LABORATORIES~~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068704	10/26/1994	NY				M	08/23/1994	pt recvd vax; itching after 2 days w/ hives; 28dec93 no response to f/u request;				Y					U					UNK	UNK				~ ()~~~In patient	CO5137	1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068705	10/26/1994	TX	41.0	41		F	08/23/1994	pt recvd vax; immediate redness & swelling to site w/ itching; swelling after 24 hrs included entire top of arm; fatigue, low grade t; lasted approx 2 days; swelling & redness to arm lasted 1 wk;									Y	10/07/1993	10/07/1993	0		PVT	UNK	none;	na;	na;	none;~ ()~~~In patient	CO5139	1						1	Asthenia; Injection site hypersensitivity; Injection site oedema; Myalgia; Oedema peripheral; Pruritus; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41125~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068706	10/26/1994	TX				F	08/23/1994	pt recvd vax; immediate itching sensation; swelling in the arm w/ redness; swelling & redness did not subside until approx 1 wk; felt achy immediately & ran low grade t which subsided after 2 days;									Y	10/07/1993	10/07/1993	0		PVT	UNK	none;	na;	na;	none;~ ()~~~In patient	CO5140	1						1	Myalgia; Oedema peripheral; Pruritus; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41125~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068707	10/26/1994	TX	49.0	49		F	08/23/1994	pt recvd vax; sore arm w/ hard red welt w/ red surrounding are that persisted about 6 days; no tx;									Y	10/07/1993	10/07/1993	0		PVT	UNK	none;	na;	na;	none;~ ()~~~In patient	CO5141	1						1	Myalgia; Skin nodule; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41125~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068708	10/26/1994	OH	32.0	32		M	08/23/1994	pt recvd vax; general weakness, flu like sxs, severe n & v; many flu shots in the past;									Y	09/29/1993	09/30/1993	1		OTH	PUB	none;	none;	none;	none;~ ()~~~In patient	CO5142	1						1	Asthenia; Influenza; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~3F41124~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068709	10/26/1994	OH	30.0	30		M	08/23/1994	extreme h/a, nausea & fever;									Y	09/29/1993	09/30/1993	1		OTH	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	CO5143	1						1	Headache; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41124~3~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068710	10/26/1994	OH	36.0	36		M	08/23/1994	severe h/a, clammy, flu like sxs, achy, constant bowel movement feeling; several flu shots in the past;									Y	09/29/1993	09/30/1993	1		OTH	PUB				~ ()~~~In patient	CO5144	1						1	Gastrointestinal disorder; Headache; Hyperhidrosis; Influenza; Myalgia	FLU3~CONNAUGHT LABORATORIES~3F41124~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068711	10/26/1994	OH	39.0	39		F	08/23/1994	pt recvd vax; swelling approx 4 in diam w/ raised the size of an egg; swelling started to diminish some w/in 2 days but most of swelling & discoloration was there x 7 days; many flu shots in the past;									Y	09/29/1993	09/29/1993	0		OTH	PUB	bentyl; cytotec; feldene;	none;	irritable bowel, bursitis of hip;	none;~ ()~~~In patient	CO5145	1						1	Oedema; Skin discolouration; Skin nodule	FLU3~CONNAUGHT LABORATORIES~3F41124~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068712	10/26/1994	OH	32.0	32		F	08/23/1994	pt recvd vax; swelling & redness at area of shot; h/a; several flu shots in the past;									Y	09/30/1993				UNK	UNK				~ ()~~~In patient	CO5146	1						1	Headache; Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~3F41124~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068713	10/26/1994	OH	29.0	29		F	08/23/1994	pt recvd vax; swelling about size of 50 cents piece & redness around area; lasted 2 days; several fly shots in the past;									Y	09/30/1993	09/30/1993	0		OTH	PUB		na;	na;	none;~ ()~~~In patient	CO5147	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~3F41124~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068714	10/26/1994	NY	69.0	69		M	08/23/1994	pt recvd vax; shaking & felt hot eve of vax; went to er; fever of 103 w/ tachycardia; was adm; in am 16nov93 t 101, then nl; 19jan94 fully recovered in 24 hrs; CBC & blood chemistries nl;					Y	1			Y	11/15/1993	11/15/1993	0		PVT	UNK	none;	none;	allergy to pcn;	none;~ ()~~~In patient	CO5149	1						1	Pyrexia; Tachycardia; Tremor	FLU3~CONNAUGHT LABORATORIES~3F41140~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0068715	10/26/1994	NJ	29.0	29		F	08/23/1994	pt recvd vax; intermittant pain at inject site;									U	10/29/1993				UNK	UNK	none;			~ ()~~~In patient	CO5150	1						1	Injection site pain	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068716	10/26/1994	OH	51.0	50		F	08/23/1994	pt recvd vax; back & joint pain; as of 16nov93, joint discomfort cont w/ swelling; still has trouble walking; no fever or local rxn; sed rate elevated;									N	11/01/1993	11/01/1993	0		UNK	UNK	none;		none;	~ ()~~~In patient	CO5151	1						1	Arthralgia; Back pain; Gait disturbance; Oedema; Red blood cell sedimentation rate increased	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068717	10/26/1994	NJ	59.0	59		F	08/23/1994	pt recvd vax; redness at site about 50 cents size w/ extreme itching;									Y	11/09/1993	11/09/1993	0		OTH	UNK			lots of environmental allergies; none known to meds;	~ ()~~~In patient	CO5152	1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~3F41171~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068718	10/26/1994	MD				F	08/23/1994	pt recvd vax; swelling in arm, hives, fever in it, weighty arm; no resp for request for info from employer;									U	11/15/1993				UNK	UNK				~ ()~~~In patient	CO5153	1						1	Myasthenic syndrome; Oedema peripheral; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068719	10/26/1994	NJ	54.0	54		U	08/23/1994	pt recvd vax;joint pain in knees 2 days after vax which has cont since 5nov93;as of 6nov93 generalized joint pains;no oth sxs except soreness at site;apap & motrin given;10jan94 predsone for arthralgia & myalgia;gradually better; ESR 27;				Y					Y	11/03/1993	11/05/1993	2		PVT	PVT	seldane, prn;	sneezing, coughing,sore throat x 2 wks;	lots of allergies both to environment & drugs;	~ ()~~~In patient	CO5154	1						1	Arthralgia; Injection site pain; Myalgia; Red blood cell sedimentation rate increased	FLU3~CONNAUGHT LABORATORIES~3F41029~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068722	10/26/1994	MO	25.0	25		M	08/23/1994	pt recvd vax; n; v; muscle weakness w/ significant elevated CPK & LDH enzymes; on 20nov93 returned to work & enzyme levels returning to nl;									Y	11/06/1993	11/09/1993	3		MIL	MIL	tetracycline;		acne, nka hx;	~ ()~~~In patient	CO5169	1						1	Blood creatine phosphokinase increased; Blood lactate dehydrogenase increased; Myasthenic syndrome; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068723	10/26/1994	CA				U	08/23/1994	pt recvd vax; had amnesia;									U					UNK	UNK				~ ()~~~In patient	CO5171	1						1	Amnesia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068724	10/26/1994	NJ	36.0	36		F	08/23/1994	pt recvd vax; swollen, slightly red, hot to touch area at inject site;									Y	11/23/1993	11/24/1993	1		PVT	PVT	none;	none;	none;	none;~ ()~~~In patient	CO5172	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068725	10/26/1994	CA				F	08/23/1994	chest pain 5 days 17DEC93 No response to f/u request;									U					UNK	UNK				~ ()~~~In patient	CO5173	1						1	Chest pain	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068726	10/26/1994	PA	16.0			U	08/23/1994	lymph edema of the arm; No other details provided; 17DEC94 No response to f/u request;									U					UNK	UNK				~ ()~~~In patient	CO5174	1						1	Lymphadenopathy	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068728	10/26/1994	CA	4.0			M	08/23/1994	can not focus, rolls head to one side; only happens when concentrates; started 5 days p/vax; 2DEC93 MD optomitrist, called discuss; 7DEC93 written f/u to MD; No response to request for more info;				Y					N					OTH	OTH				~ ()~~~In patient	CO5181	1						1	Hypotonia; Visual disturbance	FLU3~CONNAUGHT LABORATORIES~3F41007~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068729	10/26/1994	IL	7.0	7		M	08/23/1994	hives all over the body; went to ER; was seen in office & given Epi & a prescription for Atarax; received 1st dose in October w/o problem;				Y					Y	11/27/1993	11/27/1993	0		PVT	UNK	NONE	NONE	Allergy to Septra	No~ ()~~~In patient	CO5182	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~3F41027~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068730	10/26/1994	OR	79.0	79		M		pain in arm upper deltoid muscle; No swelling or redness; mobility fine;									U	10/13/1993	10/13/1993	0		PUB	OTH				~ ()~~~In patient	CO5187	1						1	Myalgia	FLU3~CONNAUGHT LABORATORIES~3J41146~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068731	10/26/1994	NE	71.0			M	08/23/1994	maculopapular rash on body 48 hrs p/vax;									U					MIL	MIL	NONE			~ ()~~~In patient	CO5188	1						1	Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068732	10/26/1994	VA	38.0	37		M	08/23/1994	herpes zoster, itchy rt neck, back & upper arm; pain in arm immed p/vax; 10JAN94 no response to f/u request;									U	11/08/1993	11/24/1993	16		PUB	PUB				~ ()~~~In patient	CO5189	1						1	Herpes zoster; Pain; Pruritus	FLU3~CONNAUGHT LABORATORIES~3J41019~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068733	10/26/1994	TX	46.0	46		F	08/23/1994	body aches, fever, edema eyelids & breast tenderness; testing: CXR, breast ultrasound, CBC, SMA, ESR, IGG, IgE, IgM; not completely recovered;									U	10/05/1993	10/05/1993	0		PVT	PVT	Corgard 20 MG QD; Naprosyn	Menstruating	allergy to sulfa	No~ ()~~~In patient	CO5190	1						1	Breast pain; Face oedema; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41003~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068734	10/26/1994	TX	31.0	31		F	08/23/1994	breast tenderness bilateral mammogram, CBC, SMAC, Thyroid, Prolactin testing;				Y					U	09/30/1993	09/30/1993	0		PVT	PVT	NONE	NONE	allergic to sulfa, strawberries	~ ()~~~In patient	CO5191	1						1	Breast pain	FLU3~CONNAUGHT LABORATORIES~3F41003~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068735	10/26/1994	MI	5.0	5		F	08/23/1994	fever & vomiting 45 mins p/dose, lasting 24 hrs; recvd 2nd dose 9DEC93;									Y	11/05/1993	11/05/1993	0		PVT	PVT			hx migraine h/a, numerous ear infect; allergic to ceclor, Amoxicillin & contact environmental;	~ ()~~~In patient	CO5192	1						1	Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~3F41027~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068737	10/26/1994	WA	33.0	33		F	08/23/1994	severe h/a & rash on face morning p/receiving dose; rash on hands 5 days post vax									Y	12/17/1993	12/18/1993	1		PVT	OTH	Premarin, Prozac, Synthroid		allergic to tetanus	~ ()~~~In patient	CO5201	1						1	Headache; Rash	FLU3~CONNAUGHT LABORATORIES~3F41140~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068738	10/26/1994	LA	67.0	67		F	08/23/1994	weakness of arms & legs; peripheral neuropathy since 1975;									U	09/30/1993	10/14/1993	14		OTH	OTH	Dipyridamole, Volatren, Klonopin		peripheral neuropathy, arthritis	~ ()~~~In patient	CO5205	1						1	Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~3F41131~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068739	10/26/1994	OH				U	08/23/1994	redness of whole upper arm; knot @ inject site; 10JA94 no response to f/u request for more details;									U	12/03/1993	12/05/1993	2		OTH	OTH				~ ()~~~In patient	CO5206	1						1	Injection site mass; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41028~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068742	10/26/1994	IL	39.0	39		F	08/23/1994	hives, constriction in throat, SOB, bloating 48 hrs p/vax; sx persisting intermittently last 3 months;				Y					U	09/27/1993	09/29/1993	2		OTH	OTH	NONE		asplenia	~ ()~~~In patient	CO5218	1						1	Dyspnoea; Flatulence; Laryngospasm; Urticaria	FLU3~CONNAUGHT LABORATORIES~~6~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~1~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0068743	10/26/1994	TN	49.0	49		F	08/23/1994	raised red area 4.5 cm, hot to touch, itchy @ inject site;									Y	01/03/1994	01/03/1994	0		PVT	OTH	Talwin, Motrin, Codine, PCN	NONE		No~ ()~~~In patient	CO5221	1						1	Injection site hypersensitivity; Injection site mass; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41141~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068744	10/26/1994	TN	48.0	48		F	08/23/1994	raised red area >3cm, hot to touch, itchy @ inject site;									Y	01/03/1994	01/03/1994	0		PVT	OTH	NONE	NONE	NONE	No~ ()~~~In patient	CO5222	1						1	Injection site hypersensitivity; Injection site mass; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41141~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068745	10/26/1994	KY	36.0	36		M	08/23/1994	chills, fever, aching evening of immun; rash on elbows, body 5JAN94 next AM; 6JAN93 rash covered body; 3FEB94 has recovered;									Y	01/04/1994	01/04/1994	0		PUB	OTH	NONE	NONE	NONE	~ ()~~~In patient	CO5223	1						1	Chills; Myalgia; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~3F41033~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068746	10/26/1994	PA	79.0	79		M	08/23/1994	pt recvd vax & exp fever 106, confusion, combative behavior 6hrs post vax; admitted to hosp & sedated;				Y	Y	4			Y	10/04/1993	10/04/1993	0		OTH	OTH	Lanoxin, Procardia, ASA		undiagnosed sores in mouth 5 days prior to immunization	~ ()~~~In patient	CO5246	1						1	Confusional state; Hostility; Pyrexia	FLU3~CONNAUGHT LABORATORIES~3F41141~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0068747	10/26/1994	TN	28.0	28		M	08/23/1994	inflammation @ site day of vax; 28MAR94 f/u raised red, itchy hot area; swollen from shoulder to elbow; lasted 6-8 hrs;									Y	10/12/1993	10/12/1993	0		PVT	PVT	NONE	NONE	cerebral palsy	~ ()~~~In patient	CO5276	1						1	Injection site hypersensitivity; Injection site inflammation; Injection site mass; Injection site oedema; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~3F41141~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068748	10/26/1994	TN	55.0	55		F	08/23/1994	pain @ site of vax, onset 1 month p/dose; pain severe w/motion; no redness, induration or mass; tx w/NSAI & physical therapy w/o relief; Now devel pain lt ear, radiating down neck; 14MAR94 No response to f/u request;				Y					U	10/28/1993	11/22/1993	25		UNK	UNK				~ ()~~~In patient	CO5290	1						1	Ear pain; Injection site pain; Neck pain	FLU3~CONNAUGHT LABORATORIES~3F41032~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068749	10/26/1994	UT				M	08/23/1994	soreness @ site immed; soreness cont as of April now c/o generalized lymphadenopathy; 10AUG94 No addtl info recvd;									N	10/01/1993	10/01/1993	0		OTH	OTH				~ ()~~~In patient	CO5332	1						1	Injection site pain; Lymphadenopathy	FLU3~CONNAUGHT LABORATORIES~3F41028~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068750	10/26/1994	IL	27.0	27		F	08/23/1994	severe pain in upper arm & numbness w/profound weakness & loss of use 5 mins p/inject; tx Motrin; referred to neurologist 30NOV03 brachial plexopathy brought on by post-vaccinal synd; poss demyelinating disease; poss of MS;				Y					N	09/27/1993	09/27/1993	0		PVT	OTH		NONE	allergy PCN, DPH	NO~ ()~~~In patient	CO5340	1						1	Hypokinesia; Multiple sclerosis; Myasthenic syndrome; Neuropathy; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0067655	10/27/1994	IL	50.0	50		F	10/17/1994	pt recvd vax & whole body was shivering; t 103; flushed & hives all over legs & arms; red & raised size of quarters; shaking; 17oct h/a cont;									Y	10/14/1994	10/14/1994	0		PUB	PUB	none;	not feeling well 1st part of wk;	none;	none;~ ()~~~In patient	IL940107	1						1	Chills; Headache; Pyrexia; Tremor; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51016~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067664	10/27/1994	VA	70.0	70		M	10/17/1994	pt recvd vax & devel stomach ache & felt queasy the  next day after every meal; referred to PMD;									U	10/07/1994	10/08/1994	1		PUB	PUB	dapro; cytotec;	states well;	states NKA; waiting for inguinal hernia operation;	none;~ ()~~~In patient	VA94074	1						1	Nausea	FLU3~CONNAUGHT LABORATORIES~4F51006~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067667	10/27/1994	MI	35.0	35		F	10/20/1994	pt recvd vax & w/in 15 min felt like apple in throat; was dizzy & could not breath;shaking,nauseated; took DPH,used inhaler;to er;tx w/ epi, tagamet,steroids; c/o headache & muscle aches next day;			Y	Y					Y	10/18/1994	10/18/1994	0	referred to allergist;	PUB	PUB		none;	hx of allergy; iodine (sulfa);	none;~ ()~~~In patient	MI94146	1						1	Dizziness; Dyspnoea; Headache; Laryngospasm; Myalgia; Nausea; Tremor; Anaphylactoid reaction; Chest pain; Dizziness; Dyspnoea; Laryngospasm; Oedema; Tongue oedema	FLU3~MEDEVA PHARMA, LTD.~4F51024~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~CONNAUGHT LABORATORIES~4F51024~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening	Influenza
0067671	10/27/1994	GA				M	10/21/1994	pt recvd vax & p/ 12 hrs, exp facial swelling; redness & itching; exp chills also;				Y						10/18/1994	10/18/1994	0		PVT	PVT		none;	none;	~ ()~~~In patient		1						1	Chills; Face oedema; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4948038~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0067672	10/27/1994	PA	66.0	66		F	10/21/1994	pt recvd vax & had beefy red 8x8 cm discoloration at inject site; itch & tender;				Y					Y	10/11/1994	10/13/1994	2		PVT	PVT	lanoxin; tamoxifen; synthroid; ca; vite;	none;	hypothyroidism; svt; breast ca;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Pruritus	FLU3~PARKE-DAVIS~00974P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~LEDERLE LABORATORIES~364934~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0067675	10/27/1994	GA	53.0	53		F	10/21/1994	pt recvd vax & arm where vax given was red; inflamed & warm to touch from inject site to elbow;									Y	10/17/1994	10/18/1994	1		PVT	PVT		none;	none;	none;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site inflammation; Vasodilatation	FLU3~PFIZER\WYETH~4948071~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0067678	10/27/1994	PA	56.0	56		F	10/20/1994	pt recvd vax & had red; slightly raised area; 8cm in diam; warm to touch;										10/17/1994	10/20/1994	3	none;	PVT	PVT	biotin; tambaco; lanaxin; lasix; buspar; synthroid; ascriptin; seldane; multi v; ca+; vit c,e,b complex; Co Q10 vit; coumadin; K-dur;		allergies: sulfa; GI distress, heart disease, AI, ms/mr, hypothyroidism; depression/ anxiety;	none;~ ()~~~In patient		1						1	Oedema; Vasodilatation	FLU3~PARKE-DAVIS~00974P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~LEDERLE LABORATORIES~369934~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0067679	10/27/1994	DC	37.0			F	10/25/1994	pt recvd vax & had flu like symptoms; chills; fever; aching all over; stuff nasal passages;									Y					OTH	OTH	none;	flu like symptoms;	pcn; ampicillin; bactrim; sulfur;	~ ()~~~In patient		1						1	Chills; Influenza; Myalgia; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~4F51074~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067327	10/28/1994	OH	52.0	52		F	10/24/1994	pt recvd vax & w/in 20 min exp tightness in throat; abdo pain; urticaria; to er; tx w/ iv, epi, dph;				Y					Y	10/06/1994	10/06/1994	0	not available at this time;	PVT	PVT	premarin; provera;	none;	none;	~ ()~~~In patient		1						2	Abdominal pain; Laryngospasm; Oedema; Rash; Abdominal pain; Laryngospasm; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51085~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~4F51085~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0067706	10/28/1994	CO	39.0	39		F	10/11/1994	pt recvd vax & had red; generalized; raised circumscribed rash; urticaria; tx w/ otc meds, resolving next am;									Y	10/11/1994	10/11/1994	0	none;	PUB	PVT	none;	none;	hayfever; nonspecific;	~ ()~~~In patient	CO94069	1						1	Rash maculo-papular; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51165~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067708	10/28/1994	CO	57.0	57		F	10/20/1994	pt recvd vax & next day was dizzy on awakening; 20oct94 cont to feel sluggish, dizzy & tired;									U	10/18/1994	10/19/1994	1		PUB	PUB	premarin & provera;	none;	healthy;	pt had similar rxn in 1993 w/ flu vax;~ ()~~~In patient	CO94071	1						1	Asthenia; Dizziness; Headache; Pruritus; Somnolence	FLU3~PARKE-DAVIS~00674P~4~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0067723	10/28/1994	MI	55.0	55		M	01/24/1994	pt recvd vax  on 23dec93 & exp tingling of fingers, toes, gingiva & tongue; progressed to bell palsy w/ loss of 30-40% muscle tone; hosp 28dec93, transfer to rehab facility of ot/at;				Y	Y					12/14/1993	12/23/1993	9		PVT	PVT	none;	none;	none;	none;~ ()~~~In patient	MI94094	1						1	Facial palsy; Hypotonia; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~3F41123~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0067758	10/28/1994	MI	33.0	33		F	10/13/1994	2 1/2 hrs p/the flu vax, exp tachycardia, burning sensation above waist in thoracic area, skin, throat,bronchi, 2 hrs later discharge coming from eyes w/burning sensation; tx w/ DPH & pred;				Y					Y	10/12/1994	10/12/1994	0	NONE	PUB	PUB	NONE			~ ()~~~In patient	MI94133	1						1	Chest pain; Conjunctivitis; Eye pain; Pain; Pharyngitis; Tachycardia	FLU3~CONNAUGHT LABORATORIES~4F51023~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0067762	10/28/1994	ND	48.0	48		F	10/21/1994	pt's arm became very swollen (not just @ the site of inject); was hot to touch; pt exp a tickling & tightness in throat; temp noc 20OCT-21OCT;									Y	10/20/1994	10/20/1994	0	NONE	PVT	PVT	Atenolol	NONE	sinus problems, mitral valve prolapse (dx JUL92)	NONE~ ()~~~In patient		1						1	Laryngospasm; Oedema peripheral; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4948051~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0067763	10/28/1994	ND	46.0	46		F	10/21/1994	no pain but arm noted to have large 4 in x 2 in raised (indurated) red mark; became tender p/initial 24 hrs;									Y	10/17/1994	10/17/1994	0		PVT	PVT	B12 inject, Clonidine, SYnthroid daily, Limbitrol	NONE	allergies to many things including eggs	pt exp arm swollen 10 yrs ago w/Tetanus #1 dose;all sibling exp react w/tetanus~ ()~~~In patient	ND94019	1						1	Pain; Skin nodule; Vasodilatation	FLU3~PFIZER\WYETH~49448051~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0067766	10/28/1994	TX	40.0	40		M	10/23/1994	p/recv vax, lost conscienceness, fell/hit head on tile floor; suffered severe brain swelling, severe closed head inj, cerebral hematoma w/multiple brain contusions, fx skull, perm optic nerve damage;coma x1mo, hosp x2mo, rehab x 8mo.			Y	Y	Y	58	Y	Y	N	09/28/1993	09/28/1993	0	large volume of records available	OTH	PVT		NONE		NONE~ ()~~~In patient		1						1	Brain oedema; Cerebral haemorrhage; Coma; Neuropathy; Syncope	FLUX~UNKNOWN MANUFACTURER~359909~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0067772	10/28/1994	NY	32.0	32		F	10/21/1994	pt recvd vax & devel arm pain; t 101; chills; arm edema & dec ROM; blotchy hives; tx w/ dph,apap,cool comp; much better next day;				Y					Y	10/19/1994	10/20/1994	1	none;	PVT	PVT	synthroid; ventolin;	none;	sinusitis; allergic rhinitis in the past;	none;~ ()~~~In patient		1						1	Chills; Hypokinesia; Oedema peripheral; Pain; Pyrexia; Urticaria	FLU3~PFIZER\WYETH~4948114~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~380957~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0067776	10/28/1994	VA	46.0	46		F	10/25/1994	pt recvd vax & exp erythema; induration; pain at inject site followed by bullous lesion approx 1/2 cm; myalgias; somnolence; conjunctival inject;				Y					Y	10/18/1994	10/20/1994	2		PVT	PVT	claritin; cardizem; estroderm; fiorinol;	muscle spasm;	chronic allergic rhinitis; hbp;	~ ()~~~In patient		1						1	Conjunctivitis; Injection site hypersensitivity; Injection site mass; Injection site pain; Myalgia; Somnolence	FLU3~PFIZER\WYETH~4948109~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0067779	10/28/1994	WI	45.0	45		F	10/21/1994	pt recvd vax & w/in 15 min started itching; face turned red; rash on face; hives & swelling around inject site; to er; tx w/ atarax;				Y					Y	10/20/1994	10/20/1994	0	seen by er;	MIL	PVT		was off work; superior vena cava obstruc	diabetic; vein obstruction; chronic epstein barr; allergic to demeral codeine;	~ ()~~~In patient		1						1	Injection site oedema; Pruritus; Rash; Urticaria; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0067783	10/28/1994	NY	58.0	58		F	10/18/1994	pt recvd vax & c/o vertigo; BP 198/96;									Y	10/18/1994	10/18/1994	0		OTH	UNK	none per pt;	bad back;	none;	none;~ ()~~~In patient		1						1	Hypertension; Vertigo	FLU3~CONNAUGHT LABORATORIES~4F51067~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067785	10/28/1994	UT	39.0	39		F		pt recvd vax & devel redness; hot to the touch & hard lump in rt arm; tx w/ ice massage, apap;										10/19/1994	10/19/1994	0	none;	PVT	PVT		none;	none;	none;~ ()~~~In patient		1						1	Skin nodule; Vasodilatation	FLU3~PFIZER\WYETH~4948103~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0067793	10/28/1994	NY	83.0	83		F	10/21/1994	flu vax given at 5PM pt started having shaking chills & sweats @ 11PM; vomited 13x & had diarrhea; lost 6 pounds fluid; gave vax to 9 other pts from same vial w/no react;									Y	10/14/1994	10/14/1994	0	NONE	PVT	PVT	Vasotec; Dyazide	chronic renal failure	dust, cat	pt exp react yrs ago;~ ()~~~In patient		1						1	Chills; Diarrhoea; Hyperhidrosis; Vomiting; Weight decreased	FLU3~CONNAUGHT LABORATORIES~4F51133~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067794	10/28/1994	IL	78.0	78		F	10/25/1994	perspired profusely all noc following the flu shot; woke up next morning w/a sore thraot & laryngitis; sx lasted 48 hrs;										10/18/1994	10/18/1994	0		UNK	UNK				~ ()~~~In patient		1						1	Hyperhidrosis; Laryngitis; Pharyngitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0060763	10/31/1994	MD	44.0	44		F	02/22/1994	pt recvd vax & 8 days p/vax w/general malaise;  woke up w/wet bed; mom attempted to wake pt later, but pt was unresponsive & wet bed again;				Y					Y	10/06/1993	10/06/1993	0	CT-scan neg; 11OCT93 electroencephalogram sz activity R & L temporal lobes;	PVT	OTH			allergic to PCN; No adverse following vaccinations prior to the most recent flu vax	~ ()~~~In patient	940013861	1						2	Convulsion; Electroencephalogram abnormal; Hyperhidrosis; Nervousness; Stupor; Thinking abnormal; Urinary incontinence; Convulsion; Electroencephalogram abnormal; Malaise; Stupor; Urinary incontinence	FLUX~PFIZER\WYETH~4938159~7+~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~4938159~3~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0067804	10/31/1994	FL	57.0	57		F	10/13/1994	pt recvd vax & Lt Arm became paralysed,could not move for 5-6 hrs;h/a top of head persists p/24 hrs;advised to MD or er;exp pain at inject site;pain lt neck,Lt pectoral area plus rapid heart beat;c/o only h/a;dx acute anxiety rxn post injec									N	10/12/1994	10/12/1994	0	none;	PUB	PUB	denies;	stomach problems for 2 wks;	unk;	~ ()~~~In patient	FL94079	1						1	Anxiety; Headache; Injection site pain; Monoplegia; Myalgia; Neck pain; Paraesthesia; Tachycardia	FLU3~PARKE-DAVIS~00294P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0067824	10/31/1994	MO	65.0	65		M	10/19/1994	pt recvd vax & had fever of 100; diarrhea; v; severe headache w/ muscle aches; dry cough;									Y	10/06/1994	10/17/1994	11	none;	PVT	PVT	none;	none;	none;	~ ()~~~In patient	MO94111	1						1	Cough; Diarrhoea; Headache; Myalgia; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~4948113~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0067827	10/31/1994	MO	86.0	85		F	10/10/1994	pt recvd vax & left axillary was swelling progressing down inner aspect of left arm throughout nite approx doubling in size; pt used ice/heat on arm; discoloration fr internal bleeding occured; discoloration cleared up now;									Y	10/07/1994	10/07/1994	0	none;	PUB	PUB	none;			none;~ ()~~~In patient	MO94079	1						1	Haemorrhage; Oedema; Oedema peripheral; Skin discolouration	FLU3~CONNAUGHT LABORATORIES~4F51160~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067828	10/31/1994	MO	69.0	69		M	10/21/1994	pt recvd vax & was cold & clammy; t 97.2; c/o headache & tired feeling; skin color pale;				Y					Y	10/14/1994	10/19/1994	5	cardiac test neg; dermol provided to client;	PUB	PUB	zantac;	none;		~ ()~~~In patient	MO94080	1						1	Asthenia; Headache; Hyperhidrosis; Hypothermia; Pallor	FLU3~CONNAUGHT LABORATORIES~4F51160~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0067830	10/31/1994	MO	52.0	52		F	10/21/1994	pt recvd vax & ache all over esp down spine; site enlarged 3 in diam red & hard & warm; pt felt immediate pain w/ sensation of vax mvt through arm;									Y	10/19/1994	10/19/1994	0	none;	PUB	PUB	seldane for allergy;	none;	mold, dust, hay allergies;	~ ()~~~In patient	MO94082	1						1	Injection site hypersensitivity; Injection site mass; Myalgia; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51160~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067834	10/31/1994	UT	57.0	57		M	10/17/1994	pt recvd vax & became feverish; chills; sweats; gen achiness; dizzy; felt very weak; some food allergies; symp lasted 3 days;									Y	10/13/1994	10/13/1994	0	none;	PUB	PUB		none;	poss arthritis; food allergies ( no specific in answers );	~ ()~~~In patient	UT942723	1						1	Asthenia; Chills; Dizziness; Hyperhidrosis; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51024~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067835	10/31/1994	VA	76.0	76		M	10/21/1994	pt recvd vax & started not feeling well on sat 15oct; sl fever & lasted till tues 18oct; went to MD; pt took apap; c/o of eye infect; feels weak; tx w/ atb;				Y					N	10/14/1994	10/15/1994	1	ekg blood tests; xray at MD on 18oct;	PUB	PUB	heart med cardizen; diuretic lasix;	none;	allergic to woody products; heart condition;	~ ()~~~In patient	VA94077	1						1	Asthenia; Infection; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51006~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0067836	10/31/1994	WV	34.0	34		F	10/19/1994	pt recvd vax & felt stinging & burning at inject site as soon as inj given;pt called RPH & instructed to use cortisone cream; rest;elev arm; use apap; swelling & red around inject site monday;size of 50 cent piece & became bigger;imp w/ tx									Y	10/17/1994	10/17/1994	0	none;	PUB	PUB	synthroid; otc vits;	none;	hypothyroid disease;	~ ()~~~In patient	WV9428	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4948130~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0067839	10/31/1994	MN	76.0	76		M	10/25/1994	pt recvd vax & devel about 8 hr period of amnesia concurrent w/ time of immun; pt do not remember  shot; no other symp; 25oct no memory recall from amnesic period;					Y	1			Y	10/18/1994	10/18/1994	0		PUB	PUB		none;		none;~ ()~~~In patient	MN94047	1						1	Amnesia	FLU3~CONNAUGHT LABORATORIES~4F51165~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0067846	10/31/1994	WV	57.0	57		M	10/27/1994	progressive weakness (new) (chronic) dyspepsia weakness began approx 21OCT; seen & adm to hosp 25OCT-weakness progressed further; dx GBS				Y	Y				N	10/13/1994	10/21/1994	8	spinal tap inc proteins	PVT	PVT	Procardia XL; NTG paste; Procan-SR; Lopressor	DM, ASHD, hx of SVT	allergy to PCN (rash) Codeine-nausea)	~ ()~~~In patient		1						1	Asthenia; CSF test abnormal; Dyspepsia; Guillain-Barre syndrome	FLU3~PARKE-DAVIS~00274P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0067849	10/31/1994	KY	21.0	21		M	10/25/1994	2 hrs following vax pt noticed itching of areas of body w/hair follicles (head, armpits, pubic, chest, etc) 2 1/2 hrs welts appeared in same areas; 2 3/4 hrs restricted breathing; 3 hrs SC Epi admin followed by temporary relief;				Y					Y	10/19/1994	10/19/1994	0		PUB	OTH			dust & mold & pollen allergies, elevated liver functions, ulcers;	NA~ ()~~~In patient		1						1	Dyspnoea; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51146~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0067852	10/31/1994	NY	8.0	8		M	10/26/1994	prolonged fever, h/a, bodyaches, neck pain, redness & pain & swelling @ inject site for 5 days; required missing school & repeat visit to MD office & CBC;				Y					U	10/21/1994	10/22/1994	1	CBC	PVT	PVT	NONE	NONE	asthma, hx otitis	NONE~ ()~~~In patient		1						1	Headache; Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia; Neck pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51010~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~384959~UNK~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0067853	10/31/1994	WA	53.0	53		F	10/20/1994	12noon-HA; 230PM devel rash & chills-rash on arms, chest, upper neck, top of legs-went to ER 330PM;-was told to go home & take DPH;				Y					Y	10/18/1994	10/18/1994	0	NONE	PVT	PVT	Premarin	NONE	NONE	~ ()~~~In patient		1						1	Chills; Headache; Rash	FLU3~PFIZER\WYETH~4948032~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0067854	10/31/1994	MI	74.0	74		M	10/25/1994	21OCT94  cough, runny nose, fever, chills hot @ noc; to ER weekend following immun had xray @ that time; 25OCT94 f/u feeling much better-on Biaxin;				Y					Y	10/11/1994	10/15/1994	4	lab wk, chest xray	OTH	OTH	Nitro/DES/NA DOLOL	NONE	prostate cancer, heart condition	~ ()~~~In patient		1						1	Chills; Cough; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~4F51165~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0067855	10/31/1994	MI	74.0	74		F	10/25/1994	sweats, coughing, aching weekend following flu shot vs MD 21OCT94 dx acute bronchitis on Biaxin called back today 25OCT94;				Y					Y	10/11/1994	10/15/1994	4		OTH	PUB	Acupril-Insulin	No-some coughing-inhalation use	diabetes-allergic to leather & aerosol sprays	~ ()~~~In patient		1						1	Bronchitis; Condition aggravated; Hyperhidrosis; Myalgia	FLU3~CONNAUGHT LABORATORIES~4F51165~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0067856	10/31/1994	ND	4.0	4		F	10/25/1994	severe erythema, induration, tenderness surrounding vax site on rt thigh; area measures 7x11cm & devel w/in 24 hrs of administration;				Y					Y	10/21/1994	10/22/1994	1		PVT	PVT	Multivit, Depakote	NONE	severe retardation secondary to GBS sepsis, sz disorder	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~PFIZER\WYETH~4948041~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0536A~1~SC~RL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0067857	10/31/1994	ND	2.0	2	.3	F	10/25/1994	severe induration, erythema, tenderness surrounding inject site; area measures 11 x 12 cm & devel w/in 24 hrs of administration; pt will not flex knee or hip; had been intermittently febrile temp max 39.8;				Y					N	10/21/1994	10/22/1994	1		PVT	PVT	Albuterol, APAP, Naldecon, Multivit	NONE	chromosomal trnaslocation, ASD, VSD, cataract sz disorder	~ ()~~~In patient		1						1	Hypokinesia; Injection site hypersensitivity; Injection site mass; Injection site pain; Pyrexia	FLU3~PFIZER\WYETH~49948041~3~IM~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0536A~1~SC~RL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0067862	10/31/1994	NJ	54.0	53		F	10/26/1994	itchy scalp/hives; swollen lower lip-onset 18-19 hrs p/vax; exp itchy scalp & hives 26OCT94 also;				Y					Y	10/24/1994	10/25/1994	1	NONE	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Face oedema; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51113~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0067865	10/31/1994	WA	78.0	78		F	10/24/1994	pt husband called about 2 hrs p/shot given to report 3 swelling & pain to rt arm advised to use ice & call in AM if worse; next day came to clinic w/whole arm swollen & redness to upper arm; still sore @ elbow;				Y					N	10/20/1994	10/20/1994	0	CBC nl	PVT	PVT	Synthroid, Coumadin, Didronel, Premarin, lanoxin, Dicacor, B12, Klotrex, Ducousate	NONE	sulfa, sodium pentathol	~ ()~~~In patient		1						1	Arthralgia; Injection site hypersensitivity; Oedema peripheral; Pain	FLU3~PFIZER\WYETH~4948104~4~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~380957~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0067868	10/31/1994	CA	35.0	35		F	10/24/1994	pt reports 2 hrs p/vax started perspiring 3-4 hrs p/inject had SOB & felt nauseated; next day pt noticed a reddened site 2 inches wide (that reportedly looked like a bruise); 23OCT93 pt was advised to go to ER; MD stated was blood clot;				Y					Y	10/22/1994	10/23/1994	1	NONE	PUB	PVT		NONE	congestive heart failure, emphysema, diabetes	NA~ ()~~~In patient		1						1	Dyspnoea; Ecchymosis; Hyperhidrosis; Injection site hypersensitivity; Nausea; Skin discolouration; Thrombosis	FLU3~PFIZER\WYETH~4948068~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0067871	10/31/1994	IN	55.0	55		F	10/27/1994	neurologic pain, distal weakness of extremities; pain over the sacral spine, difficulty urination & defecation;				Y					N	10/07/1994	10/18/1994	11	CT lumbar spine-no significant findings;	PVT	OTH	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Asthenia; Back pain; Dysuria; Neuralgia	FLU3~CONNAUGHT LABORATORIES~4F51159~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0067872	10/31/1994	ND	45.0	45		F	10/17/1994	16OCT woke up eyes puffy & sore, vision can't focus; 17OCT eye dark & puffy, tingling sensation around hard mouth, arm sore, inject site 2 round sore, red; seen by MD-rx for itching Doxipin & DPH;				Y					Y	10/15/1994	10/16/1994	1	NA	OTH	PVT	Ogen-hormone	NONE	NONE	NONE~ ()~~~In patient		1						1	Amblyopia; Eye pain; Face oedema; Injection site hypersensitivity; Injection site mass; Myalgia; Paraesthesia oral; Pruritus	FLU3~CONNAUGHT LABORATORIES~4F51023~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0067874	10/31/1994	NM	48.0	48		F	10/26/1994	swelling-redness-itchy (very putty-warm);									Y	10/24/1994	10/24/1994	0		PUB	UNK	NONE	NONE	gent eye gtts/neomycin eye gtts;	~ ()~~~In patient		1						1	Oedema; Pruritus; Vasodilatation; Oedema; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4938153~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4948131~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0067875	10/31/1994	NY	3.0	3		M	10/27/1994	fever 103-104 x 4 days starting 24 hrs p/vax w/red swollen inject site 4 inches;									Y	10/21/1994	10/22/1994	1	NONE	PVT	PVT	nebulizer Vental/intal;	NONE	asthma	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51010~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~368958~UNK~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0067876	10/31/1994	MI	78.0	78		F	10/25/1994	15OCT slurred speech & weakness (recvd shot p/17OCT) & on 18OCT had weakness & wouldn't get out of bed; MD stated may have had a stroke in progress a/flu shot;  25OCT94 f/u speech clear, can use both arms-no paralysis;									Y	10/17/1994	10/18/1994	1	NONE	OTH	PUB		slurred speech & weakness		~ ()~~~In patient		1						1	Condition aggravated	FLU3~CONNAUGHT LABORATORIES~4F51165~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067877	10/31/1994	NJ	29.0	29		F	10/27/1994	pt called from another pharm 30 mins p/inject; stated that had a rash @ site;									U	10/27/1994	10/27/1994	0	NONE	PUB	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~4F51067~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067878	10/31/1994	WV	21.0	21		F	10/25/1994	w/in 20 mins pt exp erythema, swelling (sl) & numbness @ inject site & faint erythema entire arm;									Y	10/25/1994	10/25/1994	0	NONE	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Hypoaesthesia; Injection site hypersensitivity; Injection site oedema; Rash	FLU3~CONNAUGHT LABORATORIES~4F51067~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067881	10/31/1994	AL	51.0	51		F	10/21/1994	t100-no higher-onest 15OCT94 cont to 19COT94; whelps & fine rash to entire body-started w/inner arms-spread to trunk & all over by 17OCT94; inc nasal secrections 16OCT; h/a 19OCT;									Y	10/14/1994	10/15/1994	1	NONE	OTH	UNK	NONE	NONE	codeine	NONE~ ()~~~In patient		1						1	Headache; Pyrexia; Rash; Rhinitis; Urticaria	FLU3~PFIZER\WYETH~4948126~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0067883	10/31/1994	KS	76.0	76		F	10/12/1994	felt feverish had real bad cough (dry cough), sore throat, lost hearing & voice ringing in the ears; took Rubistussin DM & APAP-Tavist-D;									N	09/27/1994	09/27/1994	0		PVT	PVT		NONE	NONE	NONE~ ()~~~In patient		1						1	Cough; Deafness; Pharyngitis; Pyrexia; Speech disorder; Tinnitus	FLU3~MEDEVA PHARMA, LTD.~E2514HG~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0067884	10/31/1994	CA	43.0	43		F	10/20/1994	18OCT reports redness @ inject site approx 2 inch by 1 inch; red & elevated & hard to touch; temp 1 degree over nl; 19OCT site remains reddened; tem inc to 101; 20OCT site redness dec; no temp feels much better;									Y	10/15/1994	10/18/1994	3	NA	PUB	PVT		NONE	asthma, MVP	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Pyrexia	FLU3~PFIZER\WYETH~4948068~3~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0067887	10/31/1994	IL	73.0	73		F	10/25/1994	pt denied any allergies to chicken, eggs, feather, noemycin or mercury; denied any prev reac to flu vax; denied any recent illness; Fluvirin givne & pt had immed local react-swelling @ inject site-no other complaint;									Y	10/24/1994	10/24/1994	0		PVT	UNK		NONE	hypertension	~ ()~~~In patient		1						1	Injection site oedema	FLU3~MEDEVA PHARMA, LTD.~E2514HGA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0067889	10/31/1994	CA				F	10/27/1994	flu lik sx p/flu vax, chills, fever, sore arm;									U	10/26/1994	10/27/1994	1	NONE	PVT	PUB	unk	NONE	unk	~ ()~~~In patient		1						1	Chills; Influenza; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51071~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067891	10/31/1994	PA	10.0	10		M	10/13/1994	lg red, swelling @ site duration 1wk;									Y	09/19/1994	09/20/1994	1		PVT	PVT				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~4F51069~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067893	10/31/1994	VA	33.0	33		F	10/27/1994	noticed small red rash on lt forearm (same arm injected); rash was warm to touch & itchy; the rash cleared 8 or 9 hrs later; pt had a low grade fever of 100.6 on day 2 & 99.6 on day 3 & felt tired but fine;									Y	10/17/1994	10/17/1994	0		PVT	OTH	Norplant	NONE		~ ()~~~In patient		1						1	Asthenia; Pruritus; Pyrexia; Rash; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~3691~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0067894	10/31/1994	CA	61.0	61		M	10/28/1994	1 wk following vax pt began to feel lethargy, sense of not feeling well, muscular weakness, muscle aching, sense of not being able to ventilate adequately, fatigue progressive during the day; pt recvd vax 7OCT94-felt better 28OCT94;									Y	10/07/1994	10/14/1994	7	e.g. CXR,lab tests: CBC, CRP, SMA 24	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Dyspnoea; Malaise; Myalgia; Myasthenic syndrome; Somnolence	FLU3~PARKE-DAVIS~00274P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0067899	10/31/1994	ND	49.0	49		F	10/13/1994	elevated temp (degrees unk-no thermometer) chills, stuffed up nose, runny & sore eyes, head cold, sore throat, back & both legs ache, itchy ears 2x3 lump in rt arm that is sore;									Y	10/08/1994	10/10/1994	2	NONE	OTH	UNK	NONE	NONE	allergies PCN, Strawberries, Stadfol, Keflex, Darvon, ASA, Vancomycin; total knee rt knee replacement 1988;	NONE~ ()~~~In patient		1						1	Back pain; Eye pain; Injection site mass; Lacrimal disorder; Myalgia; Pharyngitis; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~4F51023~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067900	10/31/1994	ND	62.0	62		F	10/24/1994	pt recvd vax & throat feels burned w/ blisters; hoarse; sore throat; light body ache; listless; not comfortable;									Y	10/22/1994	10/23/1994	1	none;	OTH	PVT	amitripytilline; calan sr;	none;	allergic, pcn; errythromycin, heart palpitat;	none;~ ()~~~In patient		1						1	Dysphonia; Malaise; Myalgia; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~4751023~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067901	10/31/1994	KS	89.0	89		F	10/12/1994	pt recvd vax & devel high fever; aching all over; loss of appetite; like  old fashion flu;									U	09/23/1994				PVT	PVT	thyroid; procardia; dyazide; zantac; ogen;	mild sinusitis;	sulfa pcn;	~ ()~~~In patient		1						1	Anorexia; Influenza; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~E2514HG~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0067904	11/01/1994	IL	69.0	68		M	10/19/1994	h/a, eyes blurry, throat sore-stuffy head; improving now 19OCT94;									Y	10/14/1994	10/16/1994	2	NONE	PUB	PUB	BP meds	NONE	NONE	NONE~ ()~~~In patient	IL940108	1						1	Amblyopia; Headache; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~4F51016~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067907	11/01/1994	NC	39.0	38		F	10/20/1994	pt recvd vax & began feeling tired 730PM; slept from that time until 5 or 6AM following AM; devel severe abdo cramping @ noon;arm,neck & scapular pain same side, area pain on same side;adv APAP, ice to site; noted blueness, swelling of arm;				Y					N	10/18/1994	10/18/1994	0	NONE	PUB	PVT	Librax PRN, Anaprox early day of inject;	NONE	seldane, Erythromycin, Clindomycin, Ceclor, Ceflin, PCN	NA~ ()~~~In patient	NC94125	1						1	Abdominal pain; Asthenia; Neck pain; Oedema peripheral; Pain; Skin discolouration; Somnolence	FLU3~PARKE-DAVIS~00294P~6~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0067910	11/01/1994		59.0			M	09/28/1994	pt recvd vax & Theophylline level was 16.1 5OCT93; on 8OCT93 pt was adm to hosp; Theophylline level was 25.6 & pt had nausea & vomiting beginning on the day prior to vax & cont; EEG suggested sinus tachycardia;					Y					10/05/1993	10/08/1993	3	Theophylline level 5OCT93 16.1 mcg ml; THeophylline level 25.6 mcgml 8OCT93; pulse 127 8OCT93; ECG suggest sinus tachycardia;	UNK	UNK	Theo-dur			~ ()~~~In patient		1						1	Drug interaction; Electrocardiogram abnormal; Nausea; Tachycardia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0067912	11/01/1994	MO	34.0	34		F	10/25/1994	p/receiving the flu vax c/o itching @ the site, flushing of the face w/in another 1-2 c/o difficulty swallowing & breathing; gave DPH; to er;				Y					Y	10/23/1994	10/23/1994	0	NA	PUB	PVT		NONE	NONE	~ ()~~~In patient		1						1	Dysphagia; Dyspnoea; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4948105~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0067913	11/01/1994	OR	49.0	49		F	10/25/1994	c/o of severe h/a, rt ear pain, N/V which began on 22OCT93; advised to see MD immediately; severe sinus & ear infect				Y	Y	4			Y	10/20/1994	10/25/1994	5	NONE	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Ear pain; Headache; Nausea; Otitis media; Sinusitis; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51164~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0067914	11/01/1994	OR	47.0	47		M	10/26/1994	c/o rt arm has a pale pink color @ inject site; no redness, no streaks, no soreness, no rash; advised to see MD;				Y					U	10/20/1994	10/25/1994	5	NONE	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~4F51164~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0067915	11/01/1994	OR	37.0	37		F	10/26/1994	pt recvd vax & c/o diarrhea; no N/V; advised to see MD;				Y					N	10/12/1994	10/26/1994	14	none;	UNK	UNK	none;	none;	none;	~ ()~~~In patient		1						1	Diarrhoea	FLU3~CONNAUGHT LABORATORIES~4F51164~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0067916	11/01/1994	OR	65.0	65		M	10/25/1994	pt recvd vax & c/o arm  soreness for 2 days; exp chills on & off w/ fluctuating t since 22oct94; advised see MD;				Y					U	10/20/1994	10/22/1994	2	none;	OTH	OTH	none;	none;	none;	~ ()~~~In patient		1						1	Chills; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51164~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0067918	11/01/1994	IN	43.0	43		M	10/25/1994	pt recvd vax & had localized swelling (immediate) at inject site;									Y	10/14/1994	10/14/1994	0		PVT	PVT		none;	none;	none;~ ()~~~In patient		1						1	Injection site oedema	FLU3~MEDEVA PHARMA, LTD.~E2514HG~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0067919	11/01/1994	IL	84.0	84		F	10/26/1994	pt recvd vax & had localized swelling at inject site for every short period;									Y	10/07/1994				PVT	PVT			tetracycline; sulfa; pcn;	~ ()~~~In patient		1						1	Injection site oedema	FLU3~MEDEVA PHARMA, LTD.~E2514HG~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0067920	11/01/1994	IL	86.0	86		F	10/26/1994	pt recvd vax & had small swelling; ice applied immed; swelling went down in 5 min;									Y	10/07/1994	10/07/1994	0		PVT	PVT				~ ()~~~In patient		1						1	Oedema	FLU3~MEDEVA PHARMA, LTD.~E2514HG~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0067921	11/01/1994	IL	55.0	55		M	10/26/1994	pt recvd vax & had localized swelling immed at inj site;									Y	10/11/1994	10/11/1994	0	none;	PVT	PVT		none;	none;	~ ()~~~In patient		1						1	Injection site oedema	FLU3~MEDEVA PHARMA, LTD.~E2514HG~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0067931	11/03/1994	MO	47.0	47		F	10/24/1994	pt recvd vax & suddenly became weak; t 100.6; chilling; no energy; light headed; nausea; felt drained all w-end; feeling better 11oct94;									Y	10/07/1994	10/07/1994	0	none;	PUB	PUB	metrotrexate 2.5; aminophylline;	none;	psoriasis; sinus allergies;	none;~ ()~~~In patient	MO94084	1						1	Asthenia; Chills; Dizziness; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51160~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067933	11/03/1994	MO	78.0	78		M	10/12/1994	pt recvd vax & had sudden chills; t; v 1x; weak; no med given; sl nausea on 12oct94; 14oct94 pt recovered;									Y	10/11/1994	10/11/1994	0	none;	PUB	PUB	Lasix; d-dur; lanoxin; imodium;	none;	heart attack 80' leg amputee (tumor 1949) crohn'disease;	none;~ ()~~~In patient	MO94086	1						1	Asthenia; Chills; Nausea; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51160~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067941	11/03/1994	FL	71.0	71		M	10/28/1994	pt recvd vax & inj site sore x 3 days; 9 dyas after vax pt devel red raised rash on L upper arm; progressed to blisters which spread; tx w/ augmentin by MD;				Y					U	10/12/1994	10/21/1994	9		PUB	OTH		none;		~ ()~~~In patient		1						1	Back pain; Chest pain; Dermatitis bullous; Injection site hypersensitivity; Injection site pain; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~4F51023~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0067946	11/03/1994	TX	38.0	38		F	10/25/1994	pt recvd vax & had fever & myalgia; had chills x 2 wks after vax; hepatitis puncture; hepatitis core igG AB + ve;				Y					Y	09/21/1994	10/05/1994	14	alk p02; SGOT 291; SGPT 482; EGT 764;LDH 605; bilirubin 2.2; wbc 12,000 & lymphocytosis; CBC, SMAG	PVT	UNK				~ ()~~~In patient		1						1	Blood alkaline phosphatase increased; Hepatitis; Hyperbilirubinaemia; Infection; Injection site reaction; Lymphocytosis; Pyrexia; Urine analysis abnormal	FLU3~PFIZER\WYETH~4948109~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~364982~UNK~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0067947	11/03/1994	WI	62.0	61		F	10/31/1994	pt recvd vax & had arm was swollen between elbow & shoulder & sore to the touch; applied cold compress & took apap; swelling lasted 2 days;									Y	10/27/1994	10/28/1994	1		PUB	PUB		none;		~ ()~~~In patient	WI94098	1						1	Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~4F51165~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~366961~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0067948	11/03/1994	MD	30.0			F	10/25/1994	pt recvd vax & 9 hrs later  pt devel muscle aches; blood shot eyes & swollen eyes;									Y	10/14/1994	10/14/1994	0		PUB	OTH				~ ()~~~In patient		1						1	Conjunctivitis; Face oedema; Myalgia	FLU3~CONNAUGHT LABORATORIES~4F51015~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067951	11/03/1994	VA	46.0	46		F	10/27/1994	pt recvd vax & devel redness & swelling; soreness in RA;									Y	10/27/1994	10/27/1994	0		UNK	UNK	na;	na;	na;	~ ()~~~In patient		1						1	Myalgia; Oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51016~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067954	11/03/1994	NY	68.0	68		F	10/28/1994	pt recvd vax & had localized redness; swelling at site of vax lasting several days;									Y	10/18/1994			none;	PVT	PVT	none;	none;	none;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~4F51079~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067956	11/03/1994	FL	76.0	76		F	10/31/1994	pt recvd vax & devel flu like symp for 2 days; redness; warmth; swelling & induration of approx 10cm in diam at inj site;									Y	10/28/1994	10/29/1994	1	none;	PVT	PVT	inderal; synthroid; estrogen;	none;	pcn - rash; codeine - confus; sulfa - rash;	na;~ ()~~~In patient		1						1	Influenza; Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948195~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0070976	11/03/1994	IL	84.0	83		M	07/15/1994	pt recvd vax; 1-2 wks later,devel myoarthralgias in the hands, elbows, shoulders,hips, and thighs & neck stiffness; was tx w/ several anti-inflammatory agents;									Y	10/28/1993			pt had work up including rheumatoid factor, thyroid tests, CPK, PSA, SMA, ESR & CBC; results were not reporte	PVT	OTH			none	~ ()~~~In patient	894221006A	1						1	Arthralgia; Myalgia; Nuchal rigidity	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0070977	11/03/1994	PA				U	09/09/1994	pt recvd vax; subsequently she devel hoarseness which also persisted to the date of this report;				Y					U	10/01/1993				PVT	PVT				~ ()~~~In patient	894269001K	1						1	Dysphonia	FLUX~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0070978	11/03/1994	NJ				M	09/28/1994	pt recvd vax;24 hrs later, dizziness; saw MD; felt dizziness related to vax;									Y					OTH	OTH	unk	none		none~ ()~~~In patient	894279004K	1						1	Dizziness	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0067667	11/04/1994	MI	35.0	35		F	10/28/1994	pt had trouble breathing, tightness in chest, felt like had a swollen neck,tongue;lungs felt tight-full of fluid,felt faint was seen in er for anaphylaxis; tx w/ epi,DPH, Tagamet, Proventil, Steroids;			Y	Y					U	10/18/1994	10/18/1994	0		PUB	OTH	NONE	NONE	allergy to sulfa drugs, Iodine	~ ()~~~In patient		1						2	Dizziness; Dyspnoea; Headache; Laryngospasm; Myalgia; Nausea; Tremor; Anaphylactoid reaction; Chest pain; Dizziness; Dyspnoea; Laryngospasm; Oedema; Tongue oedema	FLU3~MEDEVA PHARMA, LTD.~4F51024~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~CONNAUGHT LABORATORIES~4F51024~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening	Influenza
0067958	11/04/1994	NC				U	10/31/1994	unk type of react, but rumored to have been adm to hosp w/poss stroke; only info available was that condition was better than noc of admission;					Y				U					OTH	OTH				~ ()~~~In patient	CO5622	1						1	Cerebrovascular accident	FLU3~CONNAUGHT LABORATORIES~4F51010~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0067959	11/04/1994	VA	52.0			F	10/31/1994	died; only has rumored info, no details about incidence;	Y	10/19/1994							N	10/18/1994	10/19/1994	1		UNK	UNK				~ ()~~~In patient	CO5625	1						1	Arteriosclerosis; Cardiomegaly; Hepatomegaly; Pulmonary embolism	FLU3~CONNAUGHT LABORATORIES~4F51155~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0067960	11/04/1994	OH	35.0	35		M	10/31/1994	n/v, fever & chills approx 1 1/2 hr p/inject; 14OCT t104 w/nausea & vomiting; given anti-nausea med; 16OCT given ATB but to keep food down; cont to get worse; adm to hosp 19OCT w/lower lobe pneumonia treated w/IV ATB;					Y				U	10/13/1994	10/13/1994	0		OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient	CO5646	1						1	Chills; Nausea; Pneumonia; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51023~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0067961	11/04/1994	MO				F	10/31/1994	Thrombocytopenia; hx of acute lymphoblastic leukemia; platelet count 178,000 on 18OCT94; 25OCT93 dec to 18,000; treated w/IV Ig & platelets returned to 104.000; No other info expected;				Y	Y				U	10/18/1994	10/25/1994	7		OTH	OTH			hx of acute lymphoblastic leukemia	~ ()~~~In patient	CO5658	1						1	Thrombocytopenia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0067962	11/04/1994	NJ	91.0	91		M	10/11/1994	pt recvd flu vax 30SEP94 & the next day exp hearing loss in the rt ear; the pt's daughter notes that an ENT specialist was consulted; The ENT specialist did not feel the hearing loss was related to flu vax;				Y					N	09/30/1994	10/01/1994	1		PVT	OTH	unspecified medications	unk	pt has a hx of diabetes mellitus, glaucoma, & poor circulation in the legs;	~ ()~~~In patient	894286007L	1						1	Deafness	FLU3~PFIZER\WYETH~4948032~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0067963	11/04/1994	TX	45.0	45		F	10/17/1994	pt recvd flu vax & while nurse was removing the needle from pt's arm pt became weak, dizzy & sweaty; when MD saw pt was stiff, but relaxed immed afterward; MD noted sl deviation of the eyes to the rt; pulse thready 80-96bpm & BP 106/76;					Y	1			U	10/17/1994	10/17/1994	0	CT scan: head--nl; Doppler studies of carotids--mild stenosis on left, severe stenosis on right, theophylline level 10.7;	PVT	PVT	Minitran, Monopril,Coumadin,Lasix,Pepcid,Hydralazine,Theo-dur,Micro-K	unk	severe cardiomyopathy(has been considered for cardiac transplant); pt has HTN,s/p cholecystectomy;asthma; hx of peptic ulcer disease & anemia;	~ ()~~~In patient	894292001K	1						1	Angiopathy; Asthenia; Convulsion; Eye disorder; Hypertonia; Hyperventilation; Hypotension; Vomiting	FLU3~PFIZER\WYETH~4948110~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0067966	11/04/1994	FL	0.5	0	.5	M	10/27/1994	pt recvd vax p/well baby check; pt afebrile but had a sl cold; immun occured that am;that evening devel fever up to 104,cont'd off & on thru noc & next morning,some diarrhea & very cranky, wanted to be held all noc; pt checked 20OCT94;				Y					Y	10/19/1994	10/19/1994	0	NONE	PVT	PUB	Vitamins w/flouride	mild running nose & cough	HIV (post) but PCR neg; some developmental delay secondary to cocaine exposure in utero;	NA~ ()~~~In patient	FL94083	1						1	Agitation; Diarrhoea; Pyrexia	DTP~CONNAUGHT LABORATORIES~3A51135~UNK~~RL~DTP (NO BRAND NAME)~1|FLU3~PARKE-DAVIS~00274P~UNK~~RL~INFLUENZA (SEASONAL) (FLUOGEN)~1|HIBV~PFIZER\WYETH~M520LA~UNK~~LL~HIB (HIBTITER)~1|IPV~CONNAUGHT LTD.~J1143~UNK~~RL~POLIO VIRUS, INACT. (POLIOVAX)~1	USA	Emergency room visit	Influenza
0067969	11/04/1994	VA	62.0	62		F	10/26/1994	pt recvd vax 22OCT94 between 10-12AM; on 23OCT94 approx 6PM pt's arm began to itch @ inject site & rash was noted-now rash is itching & generalized; pt was referred to PMD;				Y					U	10/22/1994	10/23/1994	1		PUB	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient	VA94079	1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~4F51016~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0067975	11/04/1994	MO	66.0	66		F		pt recvd vax, 2 1/2 or 3 hrs broke out & itched-used cortizone help some of the itching; Next day was worse, went to md; pt told to take DPH;				Y					Y	10/13/1994	10/13/1994	0		PUB	PUB	Dementia;		NONE	~ ()~~~In patient		1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~4F5116C~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0067977	11/04/1994	ND	13.0	13		F	10/27/1994	9.5 x 7 cm area of erythema, firm induration, tenderness surrounding inject site accompanied by fever (Tmax 39); appeared w/in 24 hrs of inject; treated w/hot/cold packs lt thigh affected;				Y					Y	10/26/1994	10/27/1994	1		PVT	PVT	PPD, MOM, multivit, Depakene, Unifiber, Dulcolax	NONE	CP/spastic quad, mental retardation, sz	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Pyrexia	FLU3~PFIZER\WYETH~4948041~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0536A~1~SC~LL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0067978	11/04/1994	ND	10.0	10		F	10/27/1994	6x6cm area of erythema, firm induration, tenderness surrounding inject site (appeared 10 hrs p/inject) accompained by fever (tmax 39) lt thigh affected;				Y					Y	10/26/1994	10/26/1994	0		PVT	PVT	PPD, Multivit, Depakene, APAP	NONE	cerebral palsy, mental retardation, sz	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Pyrexia	FLU3~PFIZER\WYETH~4948041~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0536A~1~SC~LL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0067979	11/04/1994	ND	9.0	9		F	10/27/1994	3x2 area of induration surrounding inject site (lt thigh) w/erythema & tenderness; also fever (tmax 39); rxn appeared in 24 hrs, resolved in 72 hrs;				Y					Y	10/26/1994	10/27/1994	1		PVT	PVT	PPD, Multivit, Ditropan, Senekot, Feosol, Dulcolax, granulex	recent tibia fx (healed);	cerebral palsy, spastic quad (closed head injury)	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Pyrexia	FLU3~PFIZER\WYETH~4948041~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0536A~1~SC~LL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0067983	11/04/1994	CT	42.0	42		M	10/31/1994	rigors, nausea, lightheadedness, fatigue, back ache lasted 1-2 days rx APAP;				Y					Y	10/19/1994	10/19/1994	0	CBC WNL	PVT	UNK		NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Back pain; Chills; Dizziness; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0067987	11/04/1994	NY	66.0	66		F	10/27/1994	pt devel react to flu vax 25OCT94; sx pain all over the body, chills all day, t104, heart palpitation, diarrhea, vomiting, mouth dry, cold sweat; call ambulance but not taken to hosp;									Y	10/25/1994	10/25/1994	0	NONE	PUB	PUB		NONE	NONE	NA~ ()~~~In patient		1						1	Chills; Diarrhoea; Dry mouth; Hyperhidrosis; Pain; Palpitations; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51006~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067996	11/04/1994	FL	37.0	37		M	10/28/1994	felt OK upon awakening 530AM 28OCT94 by 7AM nausea which got worse & h/a started & just felt bad all over; t98 @ noon;									U	10/27/1994	10/28/1994	1	unk	OTH	OTH	NONE	none;	NKA	~ ()~~~In patient		1						1	Headache; Malaise; Nausea	FLU3~CONNAUGHT LABORATORIES~4F51072~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0067997	11/04/1994	FL	40.0	40		F	10/28/1994	430PM 27OCT94 got tingling feeling all over & lips sl numb, severe h/a started @ 11PM & got worse this AM 10AM 28OCT93 achy shoulders-no temp;									U	10/27/1994	10/27/1994	0	NONE	UNK	UNK				pt states had similar react last year following vax lasting about 1-2 day & nl~ ()~~~In patient		1						1	Headache; Myalgia; Paraesthesia; Paraesthesia oral	FLU3~CONNAUGHT LABORATORIES~4F50172~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0070979	11/04/1994	AL				F	09/16/1994	pt recvd vax;subsequently devel soreness & warmth at inject site,malaise & general body achiness;									U	09/07/1994	09/08/1994	1		PVT	PVT	none	none		none~ ()~~~In patient	894269002K	1						1	Injection site pain; Malaise; Myalgia; Vasodilatation	FLU3~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0070980	11/04/1994	AL	50.0	50		F	09/23/1994	pt recvd vax;subsequently devel a 3 by 4  area of swelling & warmth at inject site;									Y	09/20/1994	09/22/1994	2		PUB	PUB	none	none	none	~ ()~~~In patient	894271001K	1						1	Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948043~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0070981	11/04/1994	AL	46.0	46		F	09/22/1994	pt recvd vax;subsequently devel a local rxn at inject site;tx w/ dph,apap & compress applied to the area;									Y	09/20/1994	09/22/1994	2		PUB	PUB	synthroid, premarin	unk		none~ ()~~~In patient	894271002K	1						1	Injection site reaction	FLU3~PFIZER\WYETH~4948043~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0070982	11/04/1994	CA	35.0			F	09/28/1994	pt recvd vax; subsequently devel a 1 diam painful area of redness swelling & induration at site of inject; rxn abated									Y	09/25/1994	09/26/1994	1		PVT	OTH			none	~ ()~~~In patient	894277001K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0070983	11/04/1994	NJ	56.0	56		F	09/30/1994	pt recvd vax;exp elevation in blood pressure to 180/106,lasted approx 6 hrs;also felt fatigue & had difficulty concentrating;									Y	09/28/1994	09/29/1994	1		OTH	OTH	ziac	none	hx of hypertension	none~ ()~~~In patient	894279001K	1						1	Asthenia; Condition aggravated; Hypertension; Stupor; Tachycardia; Thinking abnormal; Vasodilatation	FLU3~PFIZER\WYETH~4948117~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0058933	11/07/1994	CO	74.0	74		M	01/22/1994	neck pain 22OCT93, pain upper & lower extremities-weakness of arm 23OCT93; unable to stand or feed self 25OCT93; numbness & tingling of hand & feet; devel severe muscle weakness hospitalized 25OCT94; GBS			Y	Y	Y	45			Y	10/14/1993	10/22/1993	8	spinal fluid: protein 78, Glucose 69, Cytology & RPR neg;	PVT	PVT	NONE		rt hemicolectomy for carcumoral tumor FEB91	~ ()~~~In patient	CO94005	1						2	Guillain-Barre syndrome; Guillain-Barre syndrome; Hypokinesia; Myasthenic syndrome; Neck pain; Pain; Paraesthesia	FLU3~PARKE-DAVIS~00973P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLUX~PFIZER\WYETH~4938157~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation	Influenza
0067874	11/07/1994	NM	48.0	48		F	10/26/1994	swelling-redness-itchy (very putty-warm);									Y	10/24/1994	10/24/1994	0		PUB	UNK	NONE	NONE	gent eye gtts/neomycin eye gtts;	~ ()~~~In patient	NM94013	1						2	Oedema; Pruritus; Vasodilatation; Oedema; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4938153~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4948131~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0067999	11/07/1994	MI	40.0			F	11/04/1994	Numbness & weakness 1 day p/inject; 7-9 days p/gradual numbness of legs; on day 21 problems walking & was adm to hosp; Numbness in eyes p/29 days; Electromylograms=nl dx probable mild GBS					Y				U	10/10/1994	10/11/1994	1		OTH	OTH				~ ()~~~In patient	CO5662	1						1	Asthenia; Gait disturbance; Guillain-Barre syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51079~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0068003	11/07/1994	CA	68.0	68		M	10/27/1994	pt recvd vax; Lt arm became sore & swollen 20oct94 more than expected; swollen upper arm; taken to ER; ER said nothing to be done; warm to the touch & red also;  when went to ER 22oct94 sxs have now resolved;				Y					Y	10/20/1994	10/20/1994	0		PUB	PUB	none;	none;	none;	none;~ ()~~~In patient	CA94126	1						1	Injection site oedema; Myalgia; Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51025~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~358958~1~IM~LA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~4G61080~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0068007	11/07/1994	CA	41.0	41		F	10/14/1994	immed p/vax 12OCT94 pt felt dizzy & lightheaded while was walking home; later that PM felt very tired & overall aching; no fever noted; 13OCT93 exp extreme fatigue; rested most of the day & is feeling better now 14OCT94; rt arm sore;									Y	10/12/1994	10/12/1994	0	NONE	PUB	PUB		NONE	allergic to PCN; has other chronic conditions	~ ()~~~In patient	CA94130	1						1	Asthenia; Dizziness; Injection site pain; Myalgia	FLU3~CONNAUGHT LABORATORIES~4F5100B~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~358958~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0068025	11/07/1994	ID	52.0	52		F	10/24/1994	tightening of throat, tightening of chest, SOB, dizziness, chills, skin tingling-was given Epi & DPH;				Y					Y	10/24/1994	10/24/1994	0		PUB	PUB	Prosac, Estrase	NONe	NONE	~ ()~~~In patient	ID94056	1						1	Chest pain; Chills; Dizziness; Dyspnoea; Laryngospasm; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51067~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068028	11/07/1994	ID	44.0	44		M	10/18/1994	approx 3 hrs p/vax pt noted tearing eyes, facial swelling, sl SOB, sore throat, coughing; pt MD prescribed DPH which relieved SOB; pt sx lasted aprpox 16-18 hrs;				Y					Y	10/14/1994	10/14/1994	0	NONE	PUB	PVT		NONE	NONE	~ ()~~~In patient	ID94059	1						1	Cough; Dyspnoea; Face oedema; Lacrimal disorder; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~4F51024~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068029	11/07/1994	ID	55.0	55		F	10/18/1994	approx 3-3 1/2 hrs p/vax reports tight throat upper resp congestion & tightness in chest similar to asthma w/SOB; pt took sudafed w/some relief; called clinic but did not call MD; sx lasted until following AM;									Y	10/14/1994	10/14/1994	0	NONE	PUB	PVT		NONE	allergic Reglan	~ ()~~~In patient	ID94060	1						1	Asthma; Chest pain; Dyspnoea; Laryngospasm; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~4F51024~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068030	11/07/1994	ID	55.0	55		F	10/18/1994	approx 3 hrs p/vax pt noted tight throat, laryngitis, cough, sl SOB; pt did not contact clinic or MD; pt reports used ASA only; states sx lasted from onset until next AM then were gone;									Y	10/14/1994	10/14/1994	0	NONE	PUB	PVT		NONE	NONE	~ ()~~~In patient	ID94061	1						1	Cough; Dyspnoea; Laryngitis; Laryngospasm	FLU3~CONNAUGHT LABORATORIES~4F51024~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068031	11/07/1994	ID	52.0	52		F	10/26/1994	dull h/a, aching all over & chills started approx 6 hrs p/vax; did not take temp; was back to feeling nl by 12noon next day;									Y	10/21/1994	10/21/1994	0		PUB	PVT		NONE	NONE	~ ()~~~In patient	ID94062	1						1	Chills; Headache; Myalgia	FLU3~CONNAUGHT LABORATORIES~4F51024~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068036	11/07/1994	IL	50.0	50		M	10/28/1994	states woke up @ 11PM w/SOB, minor chest pain, swollen lips & ears, & watery eyes; did not consult w/MD & sx gradually resolved; some swelling around lips for 24 hrs;									Y	10/26/1994	10/26/1994	0	NONE	UNK	PUB	NONE	NONE	NONE	~ ()~~~In patient	IL940114	1						1	Chest pain; Dyspnoea; Face oedema; Lacrimal disorder	FLU3~CONNAUGHT LABORATORIES~4F51060~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068039	11/07/1994	NM	47.0	47		F	10/27/1994	pt recvd vax & noted lump @ inj site @ 2pm which began burning & stinging; next few days took off rings on affected arm due to edema; now pt c/o edema in forearm, shoulder & neck pain; unrelieved by apap;called MD ; went to hlth dept;									U	10/24/1994	10/24/1994	0	none at this time;	PUB	PUB	humulin;	diabetes;	diabetic;	~ ()~~~In patient	NM94014	1						1	Injection site mass; Injection site pain; Neck pain; Oedema peripheral; Pain	FLU3~PFIZER\WYETH~4948131W~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068040	11/07/1994	OH	48.0	47		F	11/01/1994	pt recvd vax; was wierd, dizzy; 1:30am throbbing h/a; blurred vision; cough; dyspnea; congested nose; vomited x 3; chills; 3am able to sleep in recining chair; ok by noon 31oct94 h/a last sx to go;									Y	10/30/1994	10/30/1994	0	none;	PUB	PUB	trazodone; premarin; provera;	acute sciatica;	fibromyalgia;	none;~ ()~~~In patient	OH94100	1						1	Amblyopia; Chills; Cough; Dizziness; Dyspnoea; Headache; Rhinitis; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51016~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068041	11/07/1994	OH	64.0	64		M	11/01/1994	pt recvd vax; at 8:30pm pt was shaking; uncontrollable; went away when supine; worst at 10pm; sxs gone at mid nite; no fever; no pain;									Y	10/31/1994	10/31/1994	0	none;	PUB	UNK	asprin;	none;	pacemaker inserted 11oct94;	~ ()~~~In patient	OH94101	1						1	Tremor	FLU3~CONNAUGHT LABORATORIES~4F51055~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068050	11/07/1994	SD	86.0	86		M	10/26/1994	pt recvd vax; 20oct94 seen in ER for chest pain; started 7AM after eating; walked 10 blocks to hosp; admit 22oct94 expired;	Y	10/26/1994							N	10/04/1994	10/20/1994	16	cardiac work up;	PVT	PVT	valium;	none;	nka anxiety, nervousness;	~ ()~~~In patient		1						1	Arteriosclerosis; Cardiac arrest; Chest pain; Myocardial infarction	FLU3~PFIZER\WYETH~4948100~4~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0068055	11/07/1994	OR	57.0	57		F	10/28/1994	pt recvd vax; c/o no discomfort w/ inject; no contraindications;c/o inc pain in arm on 25oct & 26oct94; unable to sleep 26oct;contacted hlth rn 27oct94 & c/o inc pain & pain when moving arm esp in shoulder area;sl puffiness in upper arm;				Y					U	10/24/1994	10/25/1994	1		OTH	PUB	none at time of inject;	had bronchitis 2 wks prior to vax;	none;	~ ()~~~In patient		1						1	Injection site oedema; Insomnia; Pain	FLU3~CONNAUGHT LABORATORIES~4F51152~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068056	11/07/1994	SD	22.0	21		F	11/01/1994	pt recvd vax; BP 76/44 11:20; apprehesion; faint feeling; chest pressure; lungs hurt; warm; P 76; pale epinephrine given sc; 94/50 - 100 11:25; 136/66 P-84 11:30; ambulance personnel arrived; 11:40 to er per ambulance;				Y					U	11/01/1994	11/01/1994	0		UNK	UNK		poss sinus infect;	allergic to ceclor;	~ ()~~~In patient		1						1	Anxiety; Chest pain; Dizziness; Pallor; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51067~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068058	11/07/1994	MS	21.0	21		M	11/01/1994	pt recvd vax; devel diarrhea; fever; myalgias 24 hrs after vax; tx clear liquids & immodium;				Y					Y	10/30/1994	10/31/1994	1	none ordered;	PVT	UNK		none;	recovering from alcohol & drugs;	~ ()~~~In patient		1						1	Diarrhoea; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0068062	11/07/1994	MI	41.0	40		F	11/02/1994	c/o sneezing-coughing & SOB 1 hr p/vax; sent to clinic for eval; pulmonary function, CXR-breathing tx;				Y					Y	10/18/1994	10/18/1994	0	plumonary function, CXR	OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Cough; Dyspnoea; Rhinitis	FLU3~CONNAUGHT LABORATORIES~4F51010~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068063	11/07/1994	PA	17.0	17		F	11/03/1994	stridor & SOB 27OCT94; has severe asthma on steroids; also has URI type sx;				Y					Y	10/26/1994	10/27/1994	1	NONE	PVT	OTH	NONE	NONE	asthma allergic rhinitis	NONE~ ()~~~In patient		1						1	Dyspnoea; Pharyngitis; Stridor	FLU3~PFIZER\WYETH~4948032~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0068064	11/07/1994	NJ	87.0			F	10/31/1994	c/o grogginess, fatigue, aches in joints & all over body; felt jumpy, tingling hands, arms, dropping things; tired-in bed about a week most of the day; h/a, noc sweats;				Y					Y	10/13/1994	10/13/1994	0	NONE	PVT	OTH	Isosibide; HArber plex vitamin; Lanoxin;	mild emphysema	NONE	~ ()~~~In patient		1						1	Arthralgia; Asthenia; Coordination abnormal; Headache; Hyperhidrosis; Nervousness; Paraesthesia; Somnolence	FLU3~PARKE-DAVIS~00574P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0068066	11/07/1994	MA	45.0	45		F	11/03/1994	24 hrs p/vax had diffuse itching; 48 hrs had hives 72 hrs later diffuse hives; 80 hrs later swollen, numb legs-went to ER & was given Epi & DPH & Pred; 36 hrs later lips became swollen & numb again & pt recvd Epi, Cortisone & Pred;				Y					Y	10/26/1994	10/27/1994	1		OTH	PUB	NA	NA	NKDA	NA~ ()~~~In patient		1						1	Face oedema; Oedema peripheral; Paraesthesia; Paraesthesia oral; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F50105~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068067	11/07/1994	CA	48.0	48		F	11/02/1994	10OCT 7PM hives localized to thighs - generalized-took DPH; 11OCT rt arm pain began until 12OCT; lymph node swelling & pain noticed 12OCT94; 13OCT bilat wrist/hand pain; 14OCT noticed red areas; dx vasculitis/arthritis secondary to vax;				Y					Y	10/10/1994	10/10/1994	0	NONE	OTH	OTH	Vitamins, nasocort inhaler, Welbutran, Premarin, Lopressor	NONE	PCN/Ceclor/Sulfa; PMH HTN/compulsive-obsessive disorder/chronic allergies/menopausal synd	~ ()~~~In patient		1						1	Arthralgia; Arthritis; Lymphadenopathy; Pain; Urticaria; Vasculitis; Vasodilatation	FLU3~PFIZER\WYETH~4948038~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0068068	11/07/1994	WA	27.0	27		F	11/02/1994	had seen TV program suggesting poss problems from flu shots so nervous-10 mins p/shot felt lightheaded, tight in chest & fell backward, striking head on glass shelf then tonic-clonic movements, irreg gurgling respirations, unresponsive;				Y					Y	10/27/1994	10/27/1994	0	BP 160/100, not post ictal, but fecal incontinence-dx vaso vagal react;	OTH	PVT	Modicon-25; multivitamin w/Ca+	NONE	NONE	NONE~ ()~~~In patient		1						1	Chest pain; Faecal incontinence; Hypertension; Injury; Muscle twitching; Respiratory disorder; Stupor; Syncope	FLU3~PFIZER\WYETH~4948146~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0068069	11/07/1994	PA	39.0	39		F	10/24/1994	1400 recvd flu vax; went to work @ 1645 felt like throat is closing up; itching of skin-face on fire; DPH, Pred, Tagamet; plenty of fluids; d/c on pred to taper, tagamet, DPH;				Y					Y	09/29/1994	09/29/1994	0	pulse oximetry 97% room air peak flow 400 cc	PVT	OTH	Zoloft, Detropan, Klonopin	NONE	PCN, EES, Claforan	~ ()~~~In patient		1						1	Laryngospasm; Pain; Pruritus	FLU3~PFIZER\WYETH~4948112~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0068072	11/07/1994	PR	56.0	56		M	10/21/1994	approx 3 hrs p/vax administration pt exp chills, malaise, SOB, etc; tx'd & released;				Y					Y	10/21/1994	10/21/1994	0		MIL	MIL	TB tine by Connaught lot# j0986			~ ()~~~In patient		1						1	Chills; Dyspnoea; Malaise	FLU3~CONNAUGHT LABORATORIES~4F51158~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1607W~UNK~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|OPV~PFIZER\WYETH~0709E12~UNK~~~POLIO VIRUS, ORAL (ORIMUNE)~1|TD~PFIZER\WYETH~4938079~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1|TYP~PFIZER\WYETH~4948084~UNK~IM~LA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|YF~CONNAUGHT LABORATORIES~4D51156~UNK~IM~RA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0068073	11/07/1994	PR	50.0	50		M	10/21/1994	approx 3 hrs p/vax administration, pt exp chills, malaise, SOB, etc; tx'd & released released from Naval hosp ER 21OCT94;				Y					Y	10/21/1994	10/21/1994	0		MIL	MIL	TB tine by Connaught lot# j09861	unk	unk	~ ()~~~In patient		1						1	Chills; Dyspnoea; Malaise	FLU3~CONNAUGHT LABORATORIES~4ES1158~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~160710~UNK~IM~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TYP~PFIZER\WYETH~4948084~UNK~IM~LA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|YF~CONNAUGHT LABORATORIES~4D51156~UNK~IM~RA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0068077	11/07/1994	CA	1.1	1	.1	M	10/28/1994	devel lt sided sz 10 hrs p/vax; temp 104;				Y					Y	10/27/1994	10/28/1994	1	PE; CT-Scan, Spinal tap; Blood count-CT Scan	PVT	PVT		NONE	congental hydrocephalus; lt sided hemiparesis	~ ()~~~In patient		1						1	Convulsion; Pyrexia	FLU3~PFIZER\WYETH~4848119~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|MMR~MERCK & CO. INC.~0603A~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0068078	11/07/1994	MA	25.0	25		M	11/01/1994	pt sought medical treatment 31OCT94 4PM lt deltoid red, warm to touch, painful treated lt arm elevated, hot packs & ATB Keflec-10 days;									Y	10/29/1994	10/30/1994	1	unk	PUB	PUB	Humulin 70/30	NONE	dilantin, Amoxicillin, Phenobarbital-IDDM	NA~ ()~~~In patient	MA9434	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51165~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068079	11/07/1994	DC	43.0	43		M	11/03/1994	erythematous patches w/hives on thorax & extremities; swelling of lt side of tongue & tingling of lt side of face; DPH given;									Y	10/25/1994	10/27/1994	2	NONE	PUB	PUB	Vasotec	NONE	heart murmur, rheumatic fever	~ ()~~~In patient		1						1	Paraesthesia; Rash; Tongue oedema; Urticaria	FLU3~PFIZER\WYETH~4948197~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068080	11/07/1994	PA	66.0	66		F	10/29/1994	next morning weak-sick-that evening during nite diarrhea & vomiting about 5x-morning very weak-no fever-body aches;									Y	10/18/1994	10/19/1994	1		PUB	UNK	NONE	NONE	NONE	unk~ ()~~~In patient	PA9503	1						1	Asthenia; Diarrhoea; Myalgia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0068081	11/07/1994	OK	45.0	45		F	11/02/1994	apporx 4 hrs p/vax exp sudden onset of runny nose, eye irritation, nasal/sinus congestion draining into nasopharynx causing coughing/wheezing, h/a, injected ocnjunctive; sx resolved w/in 24 hrs; pt did take DPH 2 hrs p/onset sx;									Y	10/30/1994	10/30/1994	0	NONE	PUB	PUB	unk	NONE	NONE	NONE~ ()~~~In patient		1						1	Asthma; Conjunctivitis; Cough; Headache; Rhinitis; Sinusitis	FLU3~CONNAUGHT LABORATORIES~4F51021~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068083	11/07/1994	IN	39.0	39		F	10/24/1994	pt states rash devel evening of 21OCT93 vaxed afternoon of 2OCT94 rash described as being on both cheeks & sides of nose & down rt side of neck; erasor to pea size when itching & raised w/edges, then fade to a measle like rash;									U	10/20/1994	10/21/1994	1		PUB	PUB	Estrogen since the age of 28	NONE	NKA	pt's son had severe allerg react to MMR as a baby;~ ()~~~In patient	IN94027	1						1	Pruritus; Rash; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~4F51165~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1417W~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0068088	11/07/1994	CA	64.0	64		F	10/31/1994	onset <24 hrs post inject; site inc itching & erythemia; erythemia 5 x 4									Y	10/29/1994	10/30/1994	1	inject site adverse react;	OTH	OTH	Pepcid, Vasotec, Relafen	NONE	allergic Gatrisin & sulfa	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~4F51055~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~LEDERLE LABORATORIES~356903~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0068089	11/07/1994	OR	38.0	38		F	11/01/1994	pt recvd vax 31OCT94 930AM & 1030 exp rash & hives on lt arm; no c/o SOB or breathing difficulty; reported itching & spreading of hives onto chest, abdo; contacted MD & was told to take DPH; 1NOV94 c/o soreness & redness in arm @ inject									Y	10/31/1994	10/31/1994	0		OTH	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Neck pain; Nuchal rigidity; Pruritus; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51024~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068092	11/07/1994	NY	79.0	79		F	11/01/1994	severe pain rt deltoid & arm; pain persists as of date of report but has diminished; pain aggravated by adduction rt arm across chest; vomited x 1 26OCT94;									U	10/25/1994	10/25/1994	0	NA	PVT	PVT	Lopressor; ASA	NONE	heart disease, Osteoarthritis	~ ()~~~In patient		1						1	Injection site pain; Pain; Vomiting	FLU3~PARKE-DAVIS~00494P~3~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1679W~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0068095	11/07/1994	OH	63.0	63		F	11/03/1994	chills, fever, upset stomach, h/a, tired; had chills & fever until next morning; the other sx approx 3 days; took APAP for 3 or 4 days;									Y	10/27/1994	10/27/1994	0		UNK	UNK				~ ()~~~In patient		1						1	Asthenia; Chills; Dysphagia; Headache; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0068096	11/07/1994	IL	99.0			F	11/02/1994	pt was to recvd 1/2 of a dose of influenza vax x 3 doses; on 26OCT93 recvd .16 cc of vax; called the office on 1NOV94 to report that on the noc of 26OCT94 had terrible chills & nausea on 27OCT94;									Y	10/26/1994	10/26/1994	0		PVT	PVT	Dyazide	NONE	allergies, norcxin, Duricef, Librax, Biaxin, Ampicillin; medical condition cardiomegaly, HPN	pt exp shaking @ 97 y/o w/Influenzae #1 dose~ ()~~~In patient		1						1	Chills; Nausea	FLU3~PARKE-DAVIS~01664P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0068101	11/07/1994	TX	32.0	32		F	11/02/1994	sore throat-PND, vomiting-diarrhea, cough;									Y	10/21/1994	10/22/1994	1	NA	OTH	PVT	BCP	NONE	NONE	NONE~ ()~~~In patient		1						1	Cough; Diarrhoea; Pharyngitis; Rhinitis; Vomiting	FLU3~PFIZER\WYETH~4948117~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068102	11/07/1994	CA	54.0	53		F	10/28/1994	large red swollen @ inject site;									N	10/27/1994	10/28/1994	1	NONE	PVT	PUB		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~4F51071~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068104	11/07/1994	VA	57.0	57		M	10/22/1994	pt was walking away & felt eyes blur & tightness in throat; pt told to sit & AP 152/94 P95- 5 mins BP 139/89, P84 throat fine; on phone c/o h/a x 2-3 days; pt treated by MD for syncopy;									Y	10/22/1994	10/22/1994	0	ECHO & EKG	OTH	OTH	NA	NA	prev episodes of syncope	~ ()~~~In patient		1						1	Amblyopia; Condition aggravated; Headache; Hypertension; Laryngospasm; Syncope; Tachycardia	FLUX~UNKNOWN MANUFACTURER~4F51055~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0068106	11/07/1994	MS	41.0	41		F	10/29/1994	2-3 mins following vax inject, pt was standing & c/o heart racing; radial pulse checked by RN counted @ 104; BP 130/92; pt sat down in chair p/10 mins-15 mins RP 80; pt given coca-cola, rechecked pulse & AP 30 mins p/inject RP 64; BP 120/88									Y	10/28/1994	10/29/1994	1	NA	OTH	PVT	Ibuprofen	NONE	NONE	~ ()~~~In patient		1						1	Hypertension; Hyperventilation; Tachycardia	FLU3~CONNAUGHT LABORATORIES~4F51059~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068107	11/07/1994	MS	70.0	70		F	10/29/1994	pt returned to flu clinic table & reported feeling dizzy, lightheaded; BP 164/70 sitting; 148/78 standing; pulse 80 regular;									Y	10/29/1994	10/29/1994	0	NA	OTH	OTH	Maxide also takes thyroid meds & sleep med	NONE	codeine, Morphine/HTN, Thyroid problems	~ ()~~~In patient		1						1	Dizziness	FLU3~CONNAUGHT LABORATORIES~4F51059~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068109	11/07/1994	VA	3.0	3		F	11/03/1994	swelling & redness & warmness all lt shoulder;									Y	11/01/1994	11/02/1994	1	NONE	PVT	PVT		NONE		~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948125~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068110	11/07/1994	CT	56.0	56		F	11/03/1994	unable to lift up rt leg, could not walk up stairs, pain in groin; took one week of gradual recovery of condition a/complete use of leg was possible;									Y	10/19/1994	10/22/1994	3		PUB	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Hypokinesia; Pelvic pain	FLU3~PFIZER\WYETH~4948122~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068111	11/07/1994	NY	68.0	67		F	11/02/1994	10 cm area edema & redness surrounding inject site; 24 hrs p/inject x 5-6 days duration;									Y	10/26/1994	10/27/1994	1		PVT	PVT			allergy PCN; hypothyroid, allerfic rhinitis	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4948104~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068112	11/07/1994	FL	45.0	45		F	10/28/1994	cough began 630PM 27JUN94 by 9PM had watery eyes & runny nose-c/o feeling bad w/cold sx today 28OCT94; states had similar react p/flu vax approx 4 yrs ago; non since & has taken it even year; t99;									U	10/27/1994	10/27/1994	0	NONE	OTH	OTH	NONE	NONE	NONE	pt exp similar rxn @ 41 yrs w/flu;~ ()~~~In patient		1						1	Cough; Lacrimal disorder; Malaise; Pharyngitis; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~4F51072~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068117	11/07/1994	CO	31.0	31		F	10/31/1994	pt states discovered raised red rash on lower arms, anterior neck & @ inject site on arrising on 30OCT94; some urticaria; inject site also warm & tender to touch-1 diam; NKA; advised to consult MD;									U	10/29/1994	10/30/1994	1		OTH	OTH	unk	NONE	unk	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Rash maculo-papular; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51164~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068118	11/07/1994	CA	72.0	72		M	10/28/1994	t102 10 hrs p/vax for 1 day; myalgia for 3 days;									Y	09/30/1994	09/30/1994	0		PVT	PVT	Coumadin; Vancenase		thrombophlebitis	~ ()~~~In patient		1						1	Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4948103~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068119	11/07/1994	WA	48.0	48		F	11/01/1994	about noon on Saturday site became reddened, itchy; area 3-4 inches in diameter cont itchy 1NOV94 when reported red, warm, no swelling or lump;									Y	10/27/1994	10/29/1994	2	NONE	OTH	PUB	NONE	NONE	NONE	pt exp rxn 20 yrs ago w/flu vax;~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4948197~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068121	11/07/1994	TX	49.0	49		M	10/21/1994	low back pain in muscles;										10/19/1993	10/20/1994	366		OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Back pain; Myalgia	FLU3~PFIZER\WYETH~4948117~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068122	11/07/1994	TX	4.0	4		F	10/31/1994	inject site & surrounding area red & swollen, hot to touch, tx Advil PRN & Duriced 250mg BID x 10d to prevent infection;									Y	10/18/1994	10/19/1994	1	NONE	PVT	PVT			loloporsencephaly	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51006~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068125	11/07/1994	FL	70.0	70		F	10/31/1994	h/a, muscle aches, weakness & dizziness w/in a few days of flu & pneumococcal vax;									Y	10/10/1994	10/12/1994	2	NA	PVT	OTH	Zestril	NONE	HTN	NA~ ()~~~In patient		1						1	Asthenia; Dizziness; Headache; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0068126	11/07/1994	CT	28.0	28		F	10/31/1994	in the morning of 22OCT93 pt felt hot, oral t103, body aches, h/a, stiff neck, malaise; illness subsided gradually until PM of 23OCT; morning of 24OCT 94 pt had no residual sx & felt well;									Y	10/20/1994	10/22/1994	2	Neg	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Headache; Malaise; Myalgia; Nuchal rigidity; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51129~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068127	11/07/1994	MN	62.0	62		F	11/02/1994	erythma-swelling-itching over the lt deltoid area surrounding the inject site shortly p/inject; gradual improvement over few days; cont 6 wks later to have subcutaneous 2x2 dense fibrous nodule, non tenderness around the site of inject;									Y	10/19/1994	10/19/1994	0		PUB	UNK	Prednisone; Methotrexalt	rheumatoid arhthritis-Sjorgren's	PCN allergy	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0068139	11/08/1994	NM	38.0	38		F	10/31/1994	pt recvd vax; 4-5 diam erythematous, hot area at inject site;									Y	10/20/1994	10/20/1994	0	na;	PUB	PUB	seldane;	none;	none;	none;~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PFIZER\WYETH~4948117~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068140	11/08/1994	NM	50.0	50		F	10/31/1994	pt recvd vax; approx 5-6 diam erythematous area at inject site; area itchy; resolved 1 wk;									Y	10/19/1994	10/19/1994	0	na;	PUB	PVT	premarin;	none;	none;	none;~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~4948117~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068141	11/08/1994	NM	42.0	42		F	10/31/1994	pt recvd vax; approx 6 diam erythematous area at inject site; area itchy; resolved w/in 2 days;									Y	10/28/1994	10/28/1994	0	na;	PUB	PVT	premarin;	none;	none;	uunk;~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PFIZER\WYETH~4948117~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068142	11/08/1994	NM	37.0	37		F	10/31/1994	pt r6ecvd vax; 3-4 diam erythematous area that was itchy at inject site; area had resolved next morning;									Y	10/20/1994	10/20/1994	0	na;	PUB	PVT	none;	none;	none;	none;~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~4948117~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068143	11/08/1994	NY	41.0	41		F	11/02/1994	pt recvd vax; 29oct94 arm swollen & red about 10 cm; lasting 4 days; itching also 29oct94;										10/28/1994	10/29/1994	1		PVT	PVT	synthroid; zoloft; amoxcil;	none;	hypothyroid; follicillitis; depression;	~ ()~~~In patient		1						1	Oedema peripheral; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4948104~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068144	11/08/1994	NM	38.0	38		F	10/31/1994	pt recvd vax; 3-4 diam erythematous area at inject site; area itchy;									Y	10/20/1994	10/20/1994	0	na;	PUB	PVT	prozac;	none;	none;	none;~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~4948117~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068152	11/09/1994	NH	68.0	68		F	11/08/1994	2d s/p immun pt became anorexic, thirsty, weak, tired; has lost 8 lbs; c/o body aches & profound muscle tenderness, labs pending;				Y					N	10/25/1994	10/27/1994	2	pending	PVT	PVT	Synthroid, Lasix, Ventolin ?	NONE	asthma, HTN, hypothyrodism, anxiety, s/p breast CA;	~ ()~~~In patient	NH94032	1						1	Anorexia; Asthenia; Myalgia; Thirst; Weight decreased	FLU3~CONNAUGHT LABORATORIES~4F51113~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068153	11/09/1994	NH	81.0	81		U		2 wks p/vax pt became weak, tired, anorexic, devel fever, cough, pneumonia; progressing to death;	Y	11/05/1994							N	10/10/1994	10/20/1994	10	K 3.3;	PVT	PVT	Insulin, Furosemide, Capoten;		IDDM, HTN, obesity	~ ()~~~In patient	NH94033	1						1	Anorexia; Asthenia; Cough; Pneumonia; Pyrexia; Thirst	FLU3~CONNAUGHT LABORATORIES~4F51113~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0068154	11/09/1994	NH	80.0	80		F	11/08/1994	2d p/vax pt became anorexic, thirsty, devel lt leg weakness; became dehydrated, was hospitalized & went into CHF- ? pneumonia;	Y	11/04/1994							N	10/14/1994	10/16/1994	2		PVT	PVT		s/p CVA many yrs ago	s/p CVA many yrs ago;	~ ()~~~In patient	NH94034	1						1	Anorexia; Dehydration; Myasthenic syndrome; Pneumonia; Right ventricular failure	FLU3~CONNAUGHT LABORATORIES~4F51113~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0068158	11/09/1994	OH	68.0	68		M	11/01/1994	pt recvd vax 27OCT94 & 28OCT94 exp ache behind rt ear & base of neck gradually worked around to front over lt eye-sometimes a sharp pain; 30OCT94 around 5PM h/a w/real sharp pain; 530PM rt sided of face had dropped & rt eye would not close;				Y					N	10/27/1994	10/28/1994	1		PUB	PUB	NONE	NONE	NONE	pt exp flu @ 65 y/o w/flu vax;~ ()~~~In patient		1						1	Eye pain; Facial palsy; Headache; Hypotonia; Neck pain; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51016~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1474W~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0068159	11/09/1994	NH	47.0	47		F	11/07/1994	inflammatory polyarthritis/tenosynovitis devel 12 hrs p/inject; additive including large knee effusions, elevated ESR over 1 wk; all other secondary causes excluded;				Y					U	10/25/1994	10/26/1994	1	synovial fluid GD II inflammatory; ANA, RF, Lyme neg; viral serologies neg; ESR 30 elevated;	PUB	PVT	Prinvil	NONE	hypertension, seasonal rhinitis	~ ()~~~In patient		1						1	Arthritis; Laboratory test abnormal; Osteoarthritis; Red blood cell sedimentation rate increased; Tenosynovitis	FLU3~CONNAUGHT LABORATORIES~4F51016~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068160	11/09/1994	VA	31.0	31		F	11/07/1994	pt recvd vax 7PM did not wait the 20 mins observation time; 10-15 mins post inject exp SOB, hives, abdo pain; was treated w/Epi, Solumedrol, & DPH; f/u w/MD again 25OCT & no further sx noted;				Y					Y	10/24/1994	10/24/1994	0	NONE	OTH	PVT	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Abdominal pain; Dyspnoea; Urticaria	FLU3~PFIZER\WYETH~4948125~2~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0068161	11/09/1994	MA	74.0	74		M	11/07/1994	started chills & shaking felt cold & queasy; wrapped up warm went to bed @ 930PM; awoke @ 8AM took med, felt nl @ noon time;									Y	11/01/1994	11/01/1994	0		PUB	PUB	NONE	NONE		~ ()~~~In patient		1						1	Chills; Nausea; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0068164	11/09/1994	SC	69.0	68		F	11/03/1994	urticaria; also devel arthritis;									Y	10/26/1994	10/28/1994	2	NONE	PVT	PVT		NONE		~ ()~~~In patient		1						1	Arthritis; Urticaria	FLU3~PFIZER\WYETH~4948121~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068165	11/09/1994	FL	33.0	33		M	11/07/1994	11AM h/a, sore arm (lt) lt side of neck sore lightheaded, BP inc  150/90; 1140AM BP 140/90 c/o nausea; sent home to rest;									Y	10/31/1994	10/31/1994	0		OTH	OTH	NA	NA	heart murmur	NA~ ()~~~In patient		1						1	Dizziness; Headache; Hypertension; Myalgia; Nausea; Neck pain	FLU3~CONNAUGHT LABORATORIES~AF51072~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068357	11/10/1994	CO	41.0	41		F	11/04/1994	pt recvd vax;4 days after vax w/ fluvirin pt at MD ofc w/ fever of 101; blood tests revealed worsening of pre-existing haemolytic anaemia & pt hosp 28oct94;pt potential candidate for liver transplant;MD said pt condition not related to vax;	Y				Y				N	10/24/1994	10/28/1994	4	24oct94 WBC 17.2, RBC 4.54, HGB 15.6; HCT 44.5, platelets 464, sgot 160, alk phos 199, bili 16.9, ldh 562, bun 14, creat 0.9, 28oct94 wbc 24.9, rbc 3.17, hgb 11.2, hct 31.4, platelets 366;	PUB	PVT	prednisone; danazol; flagyl, cipro, hemaspan, diflucan, prilosec, carafate, procrit, micronase, K-dur, coumadin, maxzide, trilisate, xanax, restoril;	chronic liver & gi tract inflammation	cryptogenic cirrhosis, ulcerative colitis, portal vein thrombosis, autoimmune phenomena, haemolytic anaemia;	~ ()~~~In patient	ALI94235	1						1	Aspartate aminotransferase increased; Blood alkaline phosphatase increased; Blood lactate dehydrogenase increased; Condition aggravated; Hyperbilirubinaemia; Leukocytosis; Pyrexia; Anaemia; Aspartate aminotransferase increased; Blood alkaline phosphatase increased; Blood lactate dehydrogenase increased; Condition aggravated; Hyperbilirubinaemia; Leukocytosis; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Results in Death	Influenza
0068361	11/10/1994	MO	68.0	68		M	10/31/1994	pt recvd vax; devel cough w/ sputum which became green in color; devel chest pain assoc w/ it; after 5 days, pt hosp for numerous problems;  MD attributed to a bacterial infect that is going around;				Y	Y	6			Y	10/13/1994	10/14/1994	1	chest x-rays; blood dx studies;	OTH	PUB	proventil; enteric asa; azmacort; ranitidine; Docusate sodium; digoxin; trisacylate; sulfa metod oxide; atrovent;	infirmed as related;	COPD, chf, angina, renal lithiasis; no allergies;	~ ()~~~In patient	MO94090	1						1	Chest pain; Cough; Infection	FLU3~CONNAUGHT LABORATORIES~4F51016~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0068362	11/10/1994	MO	45.0	45		F	10/28/1994	pt recvd vax; pt exp chills; fever & purple colored rash (pruitic) 20 hrs after vax;had also been taking septra x 10 days;				Y					Y	10/13/1994	10/14/1994	1		PUB	PUB	septra d/s x 10 days;	was being tx for UTI;		~ ()~~~In patient	MO94091	1						1	Chills; Pruritus; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~4F51133~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068366	11/10/1994	NY	53.0	53		F	11/08/1994	pt recvd vax; 4nov94 am devel stomach cramps; 5:30pm emesis cont through 6nov; unable to eat or drink during this period; afebrile; diarrhea for 24 hrs starting 5nov94; Lt arm at inject site red, warm, firm & itching;to  MD 7nov94;				Y					Y	11/03/1994	11/04/1994	1	none;	OTH	PUB	none;	none;	nka susceptible to bronchitis;	~ ()~~~In patient		1						1	Abdominal pain; Anorexia; Diarrhoea; Injection site hypersensitivity; Injection site mass; Pruritus; Vasodilatation; Vomiting	FLU3~PFIZER\WYETH~4948067~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0068367	11/10/1994	TX	35.0			M	11/07/1994	pt recvd vax; Rt brachial nerve inflammation; weakness of Rt hand musculature & sensory loss;				Y					N	10/07/1994	10/21/1994	14	nerve conduction abnormal;	MIL	MIL		na;	na;	na;~ ()~~~In patient		1						1	Laboratory test abnormal; Myasthenic syndrome; Neuritis; Paraesthesia	FLU3~PARKE-DAVIS~00248P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0068368	11/10/1994	GA	44.0	44		F	10/31/1994	pt recvd vax 13oct94; seen in er 14oct94; states had onset of wheezing 1 1/2 hrs after recvd vax;tx w/ EPI,DPH,Albuterol; 2 days later broke out in rash & swollen & wheezing; tx w/ O2 & meds;				Y					Y	10/13/1994	10/14/1994	1	O2 saturation 96% RA;	PVT	PVT		ear infect;	environmental allergies: heat, basements; asthma as a child;	~ ()~~~In patient		1						1	Asthma; Hypertension; Hyperventilation; Hypothermia; Oedema; Rash; Tachycardia	FLU3~PFIZER\WYETH~4948106~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0068371	11/10/1994		23.0			F	11/09/1994	pt c/o itching at inj site, progressed to burning sensation, lightheadedness, numbness of left hand, resolved in approx 1 hour.				Y						10/31/1994	10/31/1994	0		UNK	UNK				~ ()~~~In patient		1						1	Dizziness; Injection site pain; Paraesthesia; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0068372	11/10/1994	MI	67.0	67		F	11/07/1994	pt exp vertigo, nausea, diarrhea x3, lasted approx 5 hrs; then states 24 hrs of 'total exhaustion,','states low grade fever also.'									Y	10/31/1994	10/31/1994	0		PUB	PUB				~ ()~~~In patient	MI94162	1						1	Asthenia; Diarrhoea; Nausea; Pyrexia; Vertigo	FLU3~CONNAUGHT LABORATORIES~4F51023~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068375	11/10/1994	MO	40.0	40		F	10/25/1994	vomiting, dizziness, hot flashes, chills for 8-10 hrs, no temp elevation or aches.									Y	10/11/1994	10/16/1994	5		OTH	PVT		none	penicillin and tetanus allergy	n/a~ ()~~~In patient		1						1	Chills; Dizziness; Vasodilatation; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51164~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068376	11/10/1994	MO	29.0	29		F	10/25/1994	cough, chest pain, headache, upset stomach, diarrhea									Y	10/08/1994	10/08/1994	0		OTH	PVT	none	none	none	none~ ()~~~In patient		1						1	Chest pain; Cough; Diarrhoea; Dyspepsia; Headache	FLU3~CONNAUGHT LABORATORIES~4F51164~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068378	11/10/1994	CA	52.0	52		F		about 9 hours after inj, became very nauseated, unable to sleep, weak, dizzy and headache, lasted 2.5 days.									Y	10/12/1994	10/13/1994	1		PVT	UNK		none	n/a	none~ ()~~~In patient		1						1	Asthenia; Dizziness; Headache; Insomnia; Nausea	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0068379	11/10/1994	TX	53.0	53		F	11/05/1994	fever 100, aches, pains on 3rd day after flu shot given									Y	11/01/1994	11/04/1994	3	n/a	OTH	OTH	none		none	n/a~ ()~~~In patient		1						1	Myalgia; Pain; Pyrexia	FLU3~PFIZER\WYETH~4948117~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0067329	11/14/1994	NJ	52.0	51		F	11/08/1994	pt recvd vax; 5 hrs p/ vax & p/ dinner of wing chicken, parmeghan, pasta, fresh spinach & mushrooms, pt devel hives; dizziness; unconscious for 2-3 seconds; 911 called & taken to hosp; hosp for anaphylaxis;			Y	Y	Y				Y	10/07/1994	10/07/1994	0	IGE, histamine, IGA, IGG, IGM, CBC & diff to be done; shrimp,spinach,mushroom, tomato EGG, sed rate, glucose tsh;	PVT	PVT	azmacort; tilade; dilocor; allergy shots from greer, mixed antigen on 4oct94;	none;	bronchial asthma,allergic rhinitis;	~ ()~~~In patient		1						2	Cardiovascular disorder; Coma; Face oedema; Oedema peripheral; Syncope; Urticaria; Anaphylactoid reaction; Dizziness; Syncope; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51133~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~4F51133~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0068382	11/14/1994	NY	85.0			F	10/25/1994	pt recvd single dose of flu vax as a prophylaxis 17oct94; pt died 19oct94; cause of death unk; pt was recving many other meds;	Y	10/19/1994							N	10/17/1994	10/19/1994	2	not provided;	UNK	UNK	many meds (unspecified); prednisone;	severe chest pain the day a\flu shot;	severe chronic osteoarthritis; respiratory problems; recurrent pulmonary infections; intermittent angina w/frequent exacerbations of CHF; Parkinsons disease; HCVD; chronic bronchitis w/recurrent asthma; ASHD w/angina;	~ ()~~~In patient	32777	1						1	Anorexia; Asthenia; Condition aggravated; Dyspnoea; Lung disorder; Malaise; Somnolence; Stupor; Lung disorder; Pyrexia	FLU3~PARKE-DAVIS~00474P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00474P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Results in Death	Influenza
0068383	11/14/1994	NY	88.0			F	10/25/1994	pt recvd single dose of vax on 17oct94 as a prophylaxis; pt died 20oct94; cause of death unk; pt was receiving many oth meds;	Y	10/20/1994							N	10/17/1994	10/17/1994	0	not provided;	UNK	UNK	many meds(unspecified); antidepressant;	edema; severe obtundation; hypotensive;	osteoarthritis, back & knees; arthritis large axial joints; bladder incontinent; hx of rt mastectomy 10-12 yrs ago for breast carcinoma; chronic bacteriuria; fibromyalgia; erratic appetite; depression; degenerative heart disease;	~ ()~~~In patient	32778	1						1	Apnoea; Cardiac arrest; Condition aggravated; Hypotension; Hypotension; Syncope	FLU3~PARKE-DAVIS~00474P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00474P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Results in Death	Influenza
0068384	11/14/1994	NY	69.0			F	10/24/1994	pt recvd single dose of flu vax as a prophylaxis 17oct94; pt died 21oct94; cause of death unk; pt was receiving many oth meds;	Y	10/21/1994							N	10/17/1994	10/21/1994	4	not provided;	UNK	UNK	many meds (unspecified);		alcohol abuse -> progressive neuropathy, uncertain etiology; hypertension; atrial fibrillation; macular degeneration; constipation; recurrent UTI's; hx of left ovarian cyst; COPD; rt hip fracture, intertrochanteric, s/p internal fixation;	~ ()~~~In patient	32779	1						1	Cardiovascular disorder; Condition aggravated; Lung disorder; Lung disorder; Rhinitis	FLU3~PARKE-DAVIS~00474P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00474P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Results in Death	Influenza
0068385	11/14/1994	OH	54.0	54		F	10/25/1994	pt recvd vax;devel severe back pain;to er;dx w/ disc problem;devel szs & uncontrolled hypertension;in ICU,lost consciousness & became obtunded;remained confused;now weakness & absence of reflexes bilaterally; pt had atypical GBS;				Y	Y	25			U	10/06/1994	10/15/1994	9	1st  & 2nd MRI brain-non diagnostic;MRI spine minor bulging of disc; EMG testing indicated marked demyelination of both lower & upper extremities;	OTH	PVT	none;	none;	pt smokes;	~ ()~~~In patient	894299001K	1						1	Back pain; Confusional state; Convulsion; Guillain-Barre syndrome; Hypertension; Hyporeflexia; Neuropathy; Thinking abnormal	FLU3~PFIZER\WYETH~4948038~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0068386	11/14/1994	HI	63.0	63		F	10/25/1994	pt recvd vax; next day pt hospitalized w/ following sxs: fever; h/a; chills; inc liver func tests; new onset of arthritis & swelling of the fingertips;					Y	16			N	10/14/1994	10/15/1994	1	ast 189; alt 290; ldh 1005; sed rate 44; c-reactive prot. 10.4; bili (t) .4; rheumatoid fact neg;	PVT	PVT	premarin 0.625mg daily, Tavist-D, NSAID, Doxycycline;	Possible Lyme disease;	pt recvd flu shot last year w/ no problems; had cold a couple of wks prior to vax this year; pt's husband had no problems w/ flu shot on 17oct94;	~ ()~~~In patient	894301020K	1						1	Amblyopia; Arthritis; Hyperbilirubinaemia; Hypertension; Oedema peripheral; Ophthalmoplegia; Thrombocythaemia; Vasculitis	FLU3~PFIZER\WYETH~4948130~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0068388	11/14/1994	AL	57.0	57		F	11/01/1994	pt recvd vax; 30 min to 1 hr p/ vax, pt exp difficulty breathing; numbness & upper body tingling; went to er & was given meds; saw pmd 1nov94 due to feeling strange; advised to cont meds x 2 more days & avoid another flu vax;				Y					Y	10/31/1994	10/31/1994	0		PUB	PUB	seldane PRN;	sl congestion due to allergies exposure;	cigarette smoking; styrofoam; sulfa; pcn; iodine;	denies;~ ()~~~In patient	AL9441	1						1	Depersonalisation; Dyspnoea; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51088~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068393	11/14/1994	MA	51.0	51		F	11/04/1994	pt recvd vax; t 101 next day; eyes swollen, crusty (almost swollen shut); red/face puffy; chest tight feeling; could not sleep;									Y	11/01/1994	11/01/1994	0		UNK	PUB	none;		none;	none;~ ()~~~In patient	MA9426	1						1	Chest pain; Face oedema; Headache; Insomnia; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51025~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068394	11/14/1994	MA	54.0	54		M	11/08/1994	pt recvd vax; congestion; blurred vision; h/a; chills; throwing up (nothing);									Y	10/28/1994	10/28/1994	0		PUB	UNK	none;	none;	none;	~ ()~~~In patient	MA9427	1						1	Amblyopia; Chills; Headache; Rhinitis; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51025~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068396	11/14/1994	MI	54.0	54		F	10/06/1994	pt recvd vax;4 1/2 hrs p/ vax 3x nl size swollen arm;shoulder elbow;no redness,very tender;could not use arm;warm moist compresses used 6oct94, moset swelling gone; dizziness 6oct94;cold;shaking;severe acheness;better except dizzy 11oct94;									N	10/04/1994	10/04/1994	0		PUB	PUB	none;	none;	none;	none;~ ()~~~In patient	MI94139	1						1	Chills; Dizziness; Hypokinesia; Injection site oedema; Injection site pain; Myalgia; Tremor	FLU3~CONNAUGHT LABORATORIES~4F51165~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1474W~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0068397	11/14/1994	MI	73.0	73		F	10/19/1994	pt recvd vax; during noc noticed feeling of warmth & soreness; in am, site was swollen & red which has spread from inject site to elbow; warm to touch & pink; called MD but MD did not return call & redness is almost gone; feel better;				Y					Y	10/17/1994	10/18/1994	1		PUB	PUB				~ ()~~~In patient	MI94140	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1474W~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0068398	11/14/1994	MI	68.0	68		F	10/25/1994	pt recvd vax; fever since 22oct94; h/a; v; n; dizziness;									Y	10/21/1994	10/22/1994	1	bladder infect dx on same day as vax;	PUB	UNK		bladder infect;	gastric reflux & also thyroid disease;	none;~ ()~~~In patient	MI94141	1						1	Dizziness; Headache; Nausea; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~4948147~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068399	11/14/1994	MI	25.0	25		F	10/25/1994	pt recvd vax 24oct94 at 4pm; at 8pm welts on face itching; red blotches on face, neck & back; lumps in throat; called private MD who advised meds; feeling better  now;									Y	10/24/1994	10/24/1994	0	na;	PUB	PUB		none;	none;	none;~ ()~~~In patient	MI94142	1						1	Laryngospasm; Pruritus; Rash maculo-papular; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51059~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068403	11/14/1994	MO	62.0	62		F	11/07/1994	pt recvd vax; had stomach cramps; got hot, then became clammy & dizzy; then diarrhea;									Y	11/04/1994	11/05/1994	1		OTH	PVT		none;	none;	~ ()~~~In patient	MO94093	1						1	Abdominal pain; Diarrhoea; Dizziness; Hyperhidrosis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51015~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068405	11/14/1994	NC	37.0	37		F	10/18/1994	pt recvd vax; 12 hrs later, pt exp extreme fever; ached all other; bad chills; teeth chattering; shakes; v; very n & h/a; lasted 1 day; ran low grade t 100.8 for several days;									Y	10/11/1994	10/11/1994	0		OTH	OTH	triphasin, zantac;	none known;	ulcers, stomach ailments;	none knowwn;~ ()~~~In patient	NC94128	1						1	Chills; Headache; Myalgia; Nausea; Pyrexia; Tremor; Vomiting	FLU3~PARKE-DAVIS~00294P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0068415	11/14/1994	TX	46.0	46		F	10/20/1994	pt recvd vax; exp pain shoulder joint; by morning was worse & immobility inc to elbow & later that day joint immobility inc to wrist; this cont to today;									U	10/10/1994	10/10/1994	0	na;	PUB	PUB		none;	anemia; allergy to codeine;	sibling had rxn to 1 dose of flu vax at 34 yrs of age;~ ()~~~In Sibling	TX94250	1						1	Arthralgia; Hypokinesia	FLU3~PFIZER\WYETH~4948131~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068416	11/14/1994	TX	57.0	57		F	10/25/1994	pt recvd vax; that eve pt has fever & chills; flu like sxs; got worse; v & d that last 48 hrs; v stopped but could not eat; friday almost fainted & took to hosp for severe dehydration; dec in potassium & protein level; given IV's; in hosp;					Y	3			Y	10/14/1994	10/14/1994	0		PUB	PUB		none;	states had problems after flu vax 12 yrs ago;	in pt, rxn to 1 dose of flu vax;~ ()~~~In patient	TX94251	1						1	Anorexia; Dehydration; Diarrhoea; Hypokalaemia; Hypoproteinaemia; Influenza; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~4948131~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0068420	11/14/1994	TX	74.0	74		M	10/28/1994	pt recvd vax; exp achiness, pain in Lt lip & general malaise after vax; on 13oct94 hosp & dx w/ GBS;					Y					10/10/1994	10/13/1994	3		PVT	PVT	none;	none;	none;	~ ()~~~In patient	TX94255	1						1	Globulins increased; Guillain-Barre syndrome; Hypokinesia; Malaise; Myalgia; Myasthenic syndrome; Pain	FLU3~PFIZER\WYETH~4948110~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0068422	11/14/1994	NC	51.0	51		M	11/07/1994	pt recvd vax; pt devel GBS;					Y					10/13/1994	10/28/1994	15	inc csf protein;	PUB	UNK		none;	none;	none;~ ()~~~In patient		1						1	CSF test abnormal; Guillain-Barre syndrome; Guillain-Barre syndrome	FLU3~PARKE-DAVIS~00274P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00274P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Hospitalisation	Influenza
0068423	11/14/1994	MO	39.0	39		F	11/08/1994	pt recvd vax at work at approx 4pm; suffered a sz at 8pm at home & was admitted to hosp on 31oct94 w/ dx of szs; CT & MRI indicates blood vessel abnormality; now taking Dilantin 4ID;					Y	4			Y	10/31/1994	10/31/1994	0	MRI x 2; ct scan;	PUB	UNK		denies;	unk;	~ ()~~~In patient		1						1	Convulsion; Vascular anomaly	FLU3~CONNAUGHT LABORATORIES~4F51160~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0068426	11/14/1994	MA	82.0	82		F	11/08/1994	pt recvd vax 6 hrs later, exp diaphoresis & n; had mult episodes of v;devel weakness;seen in ofc c/o inflammation of legs;in waiting rm, pt became syncopal & orthostatic;extremely pale, sweaty & clammy; questionable petechiae; to er;				Y	Y	2			Y	10/26/1994	10/26/1994	0	at hosp, eosinophills 14% 19%; repeated on 4nov in ofc 8.57; platelet count remained WNL throughout;	OTH	PUB	timoptic (topical);	3 wks prior, pt tx for UTI & bactrim ds;	none;	~ ()~~~In patient		1						1	Asthenia; Eosinophilia; Hyperhidrosis; Orthostatic hypotension; Pallor; Petechiae; Syncope; Vomiting; Asthenia; Eosinophilia; Hyperhidrosis; Nausea; Pallor; Petechiae; Syncope; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51165~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~4F51165~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0068433	11/14/1994	CA	43.0	43		F	11/09/1994	pt recvd vax; 28oct abnormal EEG, neurological sxs of persistent h/a preceding onset of flu vax; devel urinary retention & numbness in legs, unable to ambulate; dx transverse myelitis;				Y	Y		Y		N	10/21/1994	10/24/1994	3	EEG abn; abn CSF fluid;	PVT	UNK		neurologic sxs of persistant h/a;		~ ()~~~In patient		1						1	CSF test abnormal; Electroencephalogram abnormal; Myelitis; Paraesthesia; Urinary retention	FLUX~UNKNOWN MANUFACTURER~4F51069~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0068437	11/14/1994	SD	12.0			F	11/06/1994	pt recvd vax; felt light headed; 10 min after vax, pt fainted; to clinic, EPI given; P 62, BP 140/110;				Y					Y	11/06/1994	11/06/1994	0		PUB	PUB		none;	none;	~ ()~~~In patient		1						1	Dizziness; Hypertension; Syncope	FLU3~CONNAUGHT LABORATORIES~4F51067~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068438	11/14/1994	VA	41.0	41		F	11/07/1994	pt recvd vax; t >102; pain; erythema at inject site; devel rash; general malaise;				Y					Y	10/25/1994	10/26/1994	1	na;	PUB	PUB	pepcid; relatin; bcp;	none;	tcn; pcn; cephalesporns;lomotil	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Malaise; Pyrexia; Rash; Cellulitis; Injection site hypersensitivity; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51006~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~384961~UNK~A~~PNEUMO (PNU-IMUNE)~1|FLU3~CONNAUGHT LABORATORIES~4F51006~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~384961~1~IM~RA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0068443	11/14/1994	IA	73.0	73		M	11/07/1994	cellulitis lt arm treated w/Duricef 1gm QD				Y					Y	10/24/1994	10/24/1994	0	CBC	PVT	PVT	Lasix, Inderal, Zestoril, Catapres, Procardia, Slo-Bid	NONE	HTN, COPD, Acid peptic disease	~ ()~~~In patient		1						1	Cellulitis	FLU3~PFIZER\WYETH~4948048~6~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~380960~2~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0068445	11/14/1994	ID	43.0	43		F	11/04/1994	pt c/o nausea, vomiting, diarrhea, chills & shivers; temp not taken; feels achy; unable to keep fluids down; began around 10AM this AM 4NOV94;				Y					U	11/03/1994	11/04/1994	1	NONE	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Chills; Diarrhoea; Myalgia; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51164~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068453	11/14/1994	CA	4.0	4		F	11/09/1994	acute wheezing 1/2 hrs p/vax; facial flushed hot, hrs p/vax;				Y					Y	11/07/1994	11/07/1994	0	NONE	PVT	PVT	intal Suprax, Albuterol p/event	OM, asthma	asthma; oculodermal synd	NONE~ ()~~~In patient		1						1	Condition aggravated; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51024~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068455	11/14/1994	WA	46.0	46		M	11/09/1994	pt reported experienceing pain in rt deltoid 6 days p/inject; applied moist heat 1x on 18NOV94 & began taking Ibuprofen; 9NOV94 sterile abscess 10mm on rt deltoid over inject site; streaks of erythema & heat in surrounding area;  pruritus;									Y	10/31/1994	11/05/1994	5		PUB	PUB		NONE	NONE	~ ()~~~In patient		1						1	Injection site abscess; Injection site hypersensitivity; Injection site pain; Pruritus; Skin striae; Vasodilatation	FLU3~PFIZER\WYETH~4948197~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068456	11/14/1994	WA	46.0	46		F	11/09/1994	myalgia, arthralgia, senositis joints w/ knee effusion 3 to 5 days, h/a; treated 3-5 days;									Y	11/02/1994	11/02/1994	0	NONE	PUB	PUB	Theophilline, Albutol, Zoloft, Aerobid, Intal		shogren's synd, asthma	NONE~ ()~~~In patient		1						1	Arthralgia; Headache; Myalgia; Osteoarthritis	FLU3~PFIZER\WYETH~4948197~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068457	11/14/1994	MN	56.0	56		M	11/08/1994	chills, red swollen eyes, h/a, weak knees, fatigue; took Tavist D & Advil;									U	11/07/1994	11/07/1994	0		PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Arthropathy; Asthenia; Chills; Conjunctivitis; Face oedema; Headache	FLU3~CONNAUGHT LABORATORIES~4F51087~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068461	11/14/1994	CO	39.0	39		M	10/27/1994	2 days p/inject arm remained swollen, hot & red @ inject site sx began 15 hrs p/inject;									Y	10/21/1994	10/22/1994	1	NONE	PVT	UNK	NONE	NONE	PCN allergy	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948142~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068462	11/14/1994	CA	40.0	40		F	10/28/1994	2 days p/vax nauseated, body aches x 24 hrs, sore arm; one wk later head cold, chest cold, fever;									Y	10/12/1994	10/14/1994	2	NONE	OTH	PVT	Motrin	NONE	allergies-CAT, grass, mold, heart murmur	pt exp same sx 3 yrs in a row p/flu vax;~ ()~~~In patient		1						1	Myalgia; Nausea; Pharyngitis; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~00494P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0068466	11/14/1994	IL	5.0	5		M	11/07/1994	elevated t102 w/in 6 hrs-lasting 3 days & h/a for 2 days following vax inject;									Y	10/17/1994	10/17/1994	0		PVT	PVT		NONE	NKMA	~ ()~~~In patient		1						1	Headache; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51069~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068467	11/14/1994	CO	62.0	61		F	11/03/1994	24 hrs p/vax pt devel redness, bruising & swelling @ site; approx 2 x 1 1/2 site warm to touch;									Y	10/24/1994	10/24/1994	0	NONE	PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51060~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068468	11/14/1994	DE	50.0	49		F	11/07/1994	inject site devel 4 inch diameter area of erythema & edema lasting 4-5 days; site was hot to touch; no systemic sx;									Y	10/20/1994	10/20/1994	0		PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948066~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068469	11/14/1994	PA	38.0	38		F	11/07/1994	localized erythema & edema @ inject sit 4inch diameter;									Y	10/20/1994	10/21/1994	1		PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4948066~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068470	11/14/1994	DE	42.0	42		F	11/07/1994	localized erythema, edema 4 diameter @ inject site;									Y	10/20/1994	10/21/1994	1		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4948066~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068471	11/14/1994	NY	40.0	40		M	11/08/1994	face & shoulders red & blotchy; w/in 30 mins rash was gone w/no tx necessary; had flu shot a/ w/no problem;									Y	10/18/1994	10/18/1994	0		PUB	PVT	Carafate, Citrucel, Coumadin, Colace, Dilantin, Lopressor	sz disorder, HTN	dissecting aortic aneurysm, hx stroke, HTN, sz	~ ()~~~In patient		1						1	Rash; Rash maculo-papular	FLU3~PARKE-DAVIS~00474P~2~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0068473	11/14/1994	TX	36.0			M	11/08/1994	week p/vax developed fever, aches/pain;									Y				NONE	OTH	OTH	NA		NONE	NA~ ()~~~In patient		1						1	Myalgia; Pain; Pyrexia	FLU3~PFIZER\WYETH~4948117~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068475	11/14/1994	CO	45.0	45		F	11/03/1994	28OCT94 730-8AM flu vax; 11AM non productive cough, sl tight in chest; 12N bilateral conjunctivitis, no discharge; 1P myalgias, h/a; 630P t100.8, myalgias; 29OCT94 dec conjunctivitis, inc fatigue otherwise OK									Y	10/28/1994	10/28/1994	0	NONE	OTH	UNK	Lo Estrin 1/20	NONE	PCN, Bactrim; allergic rhinitis	NONE~ ()~~~In patient		1						1	Asthenia; Chest pain; Conjunctivitis; Cough; Headache; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51055~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068477	11/14/1994	CA	81.0	81		M	11/07/1994	myalgias & pharyngitis beginning day p/inject;									Y	11/02/1994	11/03/1994	1		PVT	PVT	ASA	NONE	COPD	~ ()~~~In patient		1						1	Myalgia; Pharyngitis	FLU3~PFIZER\WYETH~4948103~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068479	11/14/1994	FL	80.0	80		M	11/08/1994	pt lt hand felt uncoordinated weak both legs, no restriction movement or dexterity; pt states feels sl improved today;									U	11/05/1994	11/06/1994	1	NONE	OTH	OTH		NONE		~ ()~~~In patient		1						1	Asthenia; Coordination abnormal	FLU3~CONNAUGHT LABORATORIES~4F51060~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068480	11/14/1994	TN	39.0	39		F	11/09/1994	pt recvd flu vax 28OCT94 1045AM by the time pt was ready to go off duty that evening 10P-11P pt devel chills, Saturday joint ached & vomiting & diarrhea started; states diarrhea subsided Monday noc 31OCT94; some aching in the joints noted;									Y	10/28/1994	10/28/1994	0	NONE	PVT	PUB	APAP	NONE	hyperthyroid	NONE~ ()~~~In patient		1						1	Arthralgia; Chills; Diarrhoea; Vomiting	FLU3~PFIZER\WYETH~4948034~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068481	11/15/1994	FL	70.0			F	10/27/1994	pt recvd vax;on 11oct94 exp weakness, tiredness, loss of appetite & not able to stand or walk;27OCT94 pt seen in ER; neurological exam was nl & pt was noted to be mobile;pt adm to hosp, tx w/ IVF;					Y				N	10/10/1994	10/11/1994	1	neurological exam was normal	PVT	UNK	Cardiac meds & oral hypoglycemic agents;	NONE	diabetes, chronic rhinitis, angina & hypertension;	~ ()~~~In patient	32930	1						1	Anorexia; Asthenia; Hypokinesia	FLU3~PARKE-DAVIS~00584P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0068482	11/15/1994	MO	38.0	38		F	11/10/1994	pt recvd vax 14OCT93 & exp SOB a/leaving work @ about 1800; SOB gradually inc SAT & SUN; then early Monday AM pt came to ER 17OCT94 w/elevated BP, SOB, dysrhythmias; pt was admitted 17OCT94 to holding bed for heart monitoring;				Y	Y	8				10/14/1994	10/14/1994	0	pt had thallium treadmill, persantine stress test & Echo, EKG's, Cardiac Cath	PVT	PVT	NONE	NONE	asthma/allergic to cats/hypertension	NONE~ ()~~~In patient		1						1	Arrhythmia; Condition aggravated; Dyspnoea	FLU3~PFIZER\WYETH~4948035~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0068485	11/15/1994	CA	30.0	30		M	11/08/1994	pt given vax 12noon, by evening of same day c/o nausea, vomiting, fever; next day seen in clinic & sent to ER-given TIgan, Phenergan, TOredol & IV fluids;				Y					Y	10/19/1994	10/19/1994	0	CBC 6 dasy prior-nl; WBC 14.7, segs 93, SMA 20=nl;	PVT	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Leukocytosis; Nausea; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51023~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0542W~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TD~LEDERLE LABORATORIES~356907~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0068488	11/15/1994	CA	31.0	31		F	11/04/1994	posterior occipital adenopathy, fever, myalgias (severe), morbulliform rash;				Y					Y	10/20/1994	11/01/1994	12	NONE x/CBC	PVT	PVT		NONE	sulfa, erythro, codeine, hydrocodone, morphine	pt exp rash/fever/nodes w/MMR~ ()~~~In patient		1						1	Lymphadenopathy; Myalgia; Pyrexia; Rash maculo-papular	DT~CONNAUGHT LABORATORIES~4B61036~UNK~~LA~DT ADSORBED (NO BRAND NAME)~1|FLU3~PARKE-DAVIS~01564P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|MMR~MERCK & CO. INC.~0892A~UNK~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0068490	11/15/1994	WI	2.0	2	.8	F	11/04/1994	24 hrs p/vax had episode of fussiness, cried several hrs; fever up to 104 29NOV & 30NOV; 2NOV woke from nap screaming; seen in clinic by MD cried almost uncontrolably; mom was able to console if held; no fever 2NOV; 4NOV pt behaving nl;				Y					Y	10/28/1994	10/29/1994	1	office visit	PVT	UNK	NONE	NONE	congenital heart defect-biscuspid aortic valve	~ ()~~~In patient		1						1	Agitation; Crying; Pyrexia; Screaming	FLU3~CONNAUGHT LABORATORIES~4F51079~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068492	11/15/1994	ME	62.0	62		F	10/31/1994	felt poorly since shot on 18OCT on 24OCT felt large welt on lt arm which had extended in AM lt upper arm 5 by 7 erythematous warm, non-indurated area of erythema; sl ax adenopathy; tx w/E-Mycin 333 tid x 10 days, DPH & ice PRN;									Y	10/18/1994	10/25/1994	7	NONE	PVT	PVT	Nasacort, Durarent, Maxain, Theodur, Calcium, Promethazine w/codeine	NONE	allergic rhinitis	~ ()~~~In patient		1						1	Injection site hypersensitivity; Lymphadenopathy; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4948036~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~4G61080~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0068493	11/15/1994	KY	39.0	39		M	11/07/1994	pt had (2) grand mal sz-1st sz 5-10mins p/vax; 2nd sz @ 7PM;									Y	10/31/1994	10/31/1994	0		PUB	PVT	Depakote & Tegretol	NONE		~ ()~~~In patient		1						1	Convulsion; Grand mal convulsion	FLU3~CONNAUGHT LABORATORIES~4S51071~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068496	11/15/1994	FL	27.0	27		F	11/10/1994	10 mins p/vax inject site became inflammed 5 x 5 & a white welt devel @ site of puncture; pt c/o warmth @ site & burning; pt took advil; 315PM pt c/o nausea & feeling warm; color pale; no rash; pt denied SOB; site less inflam;tx w/ DPH;									Y	11/09/1994	11/09/1994	0	NONE	PUB	PVT	NONE	NONE	NONE	pt became sick 1976 w/swine flu dose #1;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site inflammation; Injection site pain; Nausea; Pallor; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51059~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068498	11/16/1994	WA	46.0	46		M	11/14/1994	Pt given flu vax in outpt clinic, approx 3-1/2 hrs later devel tremors & fever. Drove to ER was admitted, tx /w fluids & meds, recovered uneventfully, D/C				Y	Y	3			Y	11/07/1994	11/07/1994	0	T 104 /p onset of sxs	UNK	UNK	doxepin, levothyroxine, pravastatin, multi vits		allerg to pcn & methocarbamol, not allerg to eggs	~ ()~~~In patient		1						1	Pyrexia; Tremor	FLU3~PARKE-DAVIS~00474P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0068501	11/16/1994	WA	38.0			F		shaking, chills, violent retching, fever 105 sudden onset 2 hrs p/inject; no other evidence of illness;					Y					10/21/1994	10/21/1994	0	blood culture-no growth	UNK	UNK	Premarin		allergies sulfa	~ ()~~~In patient		1						1	Chills; Pyrexia; Tremor; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51158~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0068505	11/16/1994	FL	96.0			F	11/09/1994	pt recvd vax 14OCT93 by 15OCT pt was dyspneic, had a rt middle lobe pneumonia & then cardiogenic shock;  BP by EMS 80/60; pt given med; 02 sat is 84% to 86%; pt c/o chest pain; EKG showed ST segment elevation inferiorly;cardiomegaly; t101	Y	10/18/1994							N	10/14/1994	10/14/1994	0	minimal urine output; good hematocrit 44; WBC count 5,000; platelet count 147,000; LDH 152; CPK 65; NA 143, K 3.7, Chloride 102, CO2 24, BUn 22, creatinine 2.6, glucose 117; PT & PTT WNL; 9AM VS BP 77/36, P162, R34, t101; lung-rhonchi;	PVT	PVT	Ampicillin, APAP #3; vit Fe, serax, Vit C	pedal edema > 3 wks; r hip pain recurren	UTI; hx heart disease & heart failure	NONE~ ()~~~In patient		1						1	Blood creatine phosphokinase increased; Cardiomegaly; Dyspnoea; Electrocardiogram ST segment elevation; Pneumonia; Pyrexia; Renal impairment; Shock	FLU3~PARKE-DAVIS~00474P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0068507	11/16/1994	NY	60.0	60		F	11/11/1994	red, swollen arm which progressed to cellulitis @ the inject site;				Y					Y	11/03/1994	11/04/1994	1	NONE	PUB	PVT	NONE	NONE	allergic codeine, Darvon, Aldomet	~ ()~~~In patient		1						1	Cellulitis; Injection site reaction; Oedema peripheral; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~384955~2~IM A~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0068508	11/16/1994	PA	72.0	72		M	11/07/1994	9PM pt began to cough deeply & frequently; between post-nasal drips (almost flood) & coughing, found breathing labored & difficult; pt told to go to ER: MD stated pt bronchi had spasmed & the medication would help;dx bronchitus;				Y					Y	10/27/1994	10/27/1994	0	CXR & medicated inhalation therapy (nebulizer)	OTH	OTH	voltaran	NONE	PCN IVP (Iodine based dye)	NONE~ ()~~~In patient		1						1	Asthma; Bronchitis; Cough; Dyspnoea; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0068513	11/16/1994	ME	55.0	54		F	10/31/1994	2 swelling since got vax then on 23OCT it got more red & swollen & moving down the arm; 24OCT 6 x 4 erythematous, sl warm non indurated area of upper arm; mild sz adenopathy; acute cellulitis; tx Cephalexin, DPH, ice;									Y	10/17/1994	10/23/1994	6		PVT	PVT	ASA	NONE	psoriasis, arthritis	~ ()~~~In patient		1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Lymphadenopathy; Vasodilatation	FLU3~PFIZER\WYETH~4948036~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~4G61080~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0068514	11/16/1994	PA	0.6	0	.6	M	11/08/1994	uncontrollable crying for 5 hrs p/vax;									Y	10/26/1994	10/26/1994	0	NONE	PVT	PVT	NONE	NONE	prematurity (EGA=26wk); gastroesophageal reflux; bradycardia	~ ()~~~In patient		1						1	Screaming	DTP~CONNAUGHT LABORATORIES~4L5104~2~IM~LL~DTP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~4F51069~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~CONNAUGHT LABORATORIES~4L61090~2~IM~LL~HIB (ACTHIB)~1|OPV~PFIZER\WYETH~378960~2~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~1	USA		Influenza
0068515	11/16/1994	CO				F	11/08/1994	itchy, swollen, red hands; painful swollen joints in hands, knees & painful lt hip;									Y				NONE	PVT	UNK		COPD	COPD, CHF, inc CHD	NONE~ ()~~~In patient		1						1	Arthralgia; Oedema peripheral; Osteoarthritis; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4948074~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068516	11/16/1994	DC	46.0	46		F	10/28/1994	itchy sensation in leg w/rash;									U	10/25/1994	10/25/1994	0	NA	PVT	PVT	Prilosec	NONE	NA	~ ()~~~In patient		1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~4F51085~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068517	11/16/1994	IL	23.0	23		F	11/14/1994	neck stiffness;										10/19/1994	10/21/1994	2	NONE	MIL	PVT			NONE	~ ()~~~In patient		1						1	Nuchal rigidity	FLU3~PARKE-DAVIS~0564P~3~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0068519	11/16/1994	MA	70.0	70		M	11/12/1994	nasal mucus, ill feeling for about 1 wk, 3 wks p/flu vax;									Y	10/18/1994	10/31/1994	13	NONE	PVT	UNK		NONE		~ ()~~~In patient		1						1	Malaise; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0068521	11/16/1994	DC	19.0	19		F	11/09/1994	approx 6 hrs p/vax pt devel itchy scattered round, irreg, red, sl elevated lesions; cont for 2 days sought tx today; given DPH;									Y	11/07/1994	11/07/1994	0		OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Pruritus; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~4F51071~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068536	11/17/1994	MO	8.0	8		M	11/09/1994	4NOV94 fever started @ 101.8 & cont until 6NOV94 then returned 7NOV94 also has had a rash; per grandmother;				Y						10/22/1994	11/04/1994	13		OTH	PUB				~ ()~~~In patient	MO94095	1						1	Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~4F51160~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068544	11/17/1994	MN	39.0	39		F	11/07/1994	leg pain, hematuria, petechia, thrombocytopenia, ITP; anemia; viral flu-like sx; petechial rash, bruising, confusion; cough productive; BP 150/90, pulse 110, cramping in lower legs; had systolic flow murmur on cardiovascular exam,to ICU			Y	Y	Y	4			Y	10/14/1994	10/18/1994	4	WBC 6.9, 86% neutrophils, 8 bands, hemoglobin 7.3, MCV 60.9, platelet count 3,000; panel was essentially nl; PT was 13.5, INR was 1.2; PPT 36.2; DIC labs revealed fibrinogen level of 207; thrombin time of 22, fibrin split parts of >1,000;	PVT	PVT	Insulin	Viral bronchitis	diabetes mellitus type 1; hashimoto's; thyroiditis;	~ ()~~~In patient		1						1	Coagulopathy; Condition aggravated; Confusional state; Hypochromic anaemia; Laboratory test abnormal; Paralysis; Thrombocytopenia; Thrombocytopenic purpura	FLU3~PFIZER\WYETH~4948113~4~SC~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0068547	11/17/1994	PA	69.0	69		F	10/25/1994	day following vax pt had very sore, feverish & swollen red arm; pt went to ER & was told had cellulitis; BP 229/92; Next day pt woke up w/sore throat & cough that devel into bronchitis; then MD prescribed a new ATB & prescription;				Y						10/19/1994	10/20/1994	1		PVT	PUB				~ ()~~~In patient		1						1	Bronchitis; Cellulitis; Cough; Hypertension; Myalgia; Oedema peripheral; Pharyngitis; Vasodilatation	FLU3~PFIZER\WYETH~4948122~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0068548	11/17/1994	MT	55.0	55		M	11/02/1994	the morning following the vax pt broke out in a total body rash w/itching & burning; itching, burning recurs q 4 hrs; seen by MD @ clinic; rx DPH, Pred, tapering dose starting dose;				Y					Y	10/28/1994	10/29/1994	1	NONE	PVT	PVT	NONE	recovering from cold	no allergies; no health problems;	NONE~ ()~~~In patient		1						1	Pain; Pruritus; Rash	FLU3~PFIZER\WYETH~4948104~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0068551	11/17/1994	NC	26.0	26		F		brachial & lumbar plexopathy w/numbness in hands & feet;									N	10/06/1994	10/13/1994	7	CBC, SMA-24, Sed rate, Mono spot-nl;	PVT	UNK		NONE	NONE	~ ()~~~In patient		1						1	Neuropathy; Paraesthesia	FLU3~PFIZER\WYETH~4948106~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068552	11/17/1994	CA	39.0	39		M	11/11/1994	swollen tender inflamed inject site lasting 3 days; 2 days p/inject began w/malaise, poss fever, green sputum;									N	11/07/1994	11/07/1994	0	NONE	PVT	PVT	NONE	poss just getting bacterial bronchitis		~ ()~~~In patient		1						1	Injection site inflammation; Injection site oedema; Injection site pain; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51006~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068556	11/18/1994	MS	63.0	63		F	11/10/1994	pt recvd vax 9AM 10OCT94 & late that afternoon about 5PM rt ear begin to feel stopped up & BY 8PM pt could not hear at all from rt ear; seen by MD 17OCT94 for ear problem tx w/no improvement; pts ear roaring sound & edema (inside ear);				Y					N	10/10/1994	10/10/1994	0	hearing test	PUB	PUB		NONE	NONE	NONE~ ()~~~In patient	MS94057	1						1	Deafness; Oedema; Tinnitus	FLU3~PARKE-DAVIS~00294P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1474W~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0068560	11/18/1994	NV	67.0	67		F	10/27/1994	pt recvd vax; 24oct94 c/o myalgia until 26oct94; 25oct94 c/o urticaria on soles of feet & palms lasting until 27oct94 & asymptomatic by 28oct94;									Y	10/22/1994	10/25/1994	3	na;	PUB	PUB	none;	denies any illnesses;	no allergies; hx of gallbladder disease;	none;~ ()~~~In patient	NV94027	1						1	Myalgia; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51024~3~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~380957~1~IM A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0068567	11/18/1994	TN	44.0	44		F	10/31/1994	pt recvd vax;noticed mouth burning & sore throat;approx 4pm,lips & tongue swollen;co-workers noticed voice change & slurred speech;advised to take DPH;saw PMD approx 4:30,given meds;p/ 4hrs pt states swelling cont & moved to hands; now nl;				Y					Y	10/28/1994	10/28/1994	0		PUB	PUB	none;	none;	thimerosal, dust, mold, rxn allergy shot;	~ ()~~~In patient	TN94142	1						1	Dysphonia; Face oedema; Oedema peripheral; Pain; Pharyngitis; Speech disorder; Tongue oedema	FLU3~CONNAUGHT LABORATORIES~4F51016~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068571	11/18/1994	NJ	66.0	66		F	11/10/1994	pt recvd vax; cardiac arrest w/ VF several hrs later; in hosp pt unconscious;	Y				Y				N	11/04/1994	11/04/1994	0		PVT	PVT				~ ()~~~In patient		1						1	Cardiac arrest; Coma; Ventricular fibrillation	FLU3~PFIZER\WYETH~4948032~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0068422	11/19/1994	NC	51.0	51		M	11/07/1994	GBS;					Y					10/15/1994	10/28/1994	13	inc CSF protein	PUB	UNK		NONE	NONE	NONE~ ()~~~In patient	NC94130	1						2	CSF test abnormal; Guillain-Barre syndrome; Guillain-Barre syndrome	FLU3~PARKE-DAVIS~00274P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00274P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Hospitalisation	Influenza
0068573	11/19/1994	PA	57.0			F	11/02/1994	6 days p/vax pt devel mid-back pain, paresthesias of fingers, n/v, anorexia, myalgia & weakness; seen by MD 28OCT94-poss flu synd; seen in ER-adm to hosp; dx GBS; pt cont exp weakness, confusion, ptosis;			Y	Y	Y	16			N	10/18/1994	10/24/1994	6	x-ray lumar spine--degenerative change, mild wedging of T4 vertebra, sedimentation rate nl, lumbar puncture--minimally elevated protein, cxc neg.; EMG: no evidence of active denervation, upper extremity F wave; vital capacity 1.1;	PVT	PVT	unk	unk	s/p hysterectomy for benign diseases; had a series of hepatitis b vaxs in the fall;	~ ()~~~In patient	894307007K	1						1	Asthenia; Back pain; Confusional state; Eyelid ptosis; Guillain-Barre syndrome; Influenza; Myalgia; Paraesthesia	FLU3~PARKE-DAVIS~00547P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation	Influenza
0068574	11/19/1994	FL	62.0	62		F		lt arm sore, warm to touch - 2 1/2 x 2 1/2 size;									N	10/28/1994	10/28/1994	0	NONE	PUB	PUB	Lothosin	NONE	metals/hypertension/CA 1987-cured	unk~ ()~~~In patient	FL94089	1						1	Injection site pain; Vasodilatation	FLU3~PARKE-DAVIS~00294P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0068578	11/19/1994	IL	69.0			F	11/04/1994	severe pain in lt arm & upper back pain & shoulders painful; shooting down arms to fingers x 15 days; hx of scar tissue on upper lt arm;									N	10/18/1994	10/18/1994	0	NA	UNK	UNK				~ ()~~~In patient	IL940118	1						1	Back pain; Pain	FLU3~CONNAUGHT LABORATORIES~4F51165~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068579	11/19/1994	IL	69.0			F	11/01/1994	diaphoresis, syncope, pulse 62, BP 130/80; pt had taken flu vax 20 mins a/syncope episode; denied prev react to vax; adm to taking Vasotec & Calan p/paramedic arrived; refused to go w/paramedic initially; paramedic summoned again pt to ER;				Y					Y	11/01/1994	11/01/1994	0	NA	OTH	PUB	Vasotec & Calan		hypertension	NA~ ()~~~In patient	IL940119	1						1	Hyperhidrosis; Syncope	FLU3~CONNAUGHT LABORATORIES~4F51165~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068580	11/19/1994	IL	61.0	61		F		Wednesday had bumps on feet, hands, & face; gums became sore; On Saturday top part of body began hurting-sensitive to touch or clothing; some itching all over on Friday; bumps gone on Monday; gums better; no c/o tiredness; poss temp;									Y	10/25/1994	10/26/1994	1	NONE	UNK	PUB	NONE	NONE	allergic to sulfa-CA uterine-1980;	pt exp flu-like sx @ 58 y/o w/flu vax #1 dose~ ()~~~In patient	IL940120	1						1	Pain; Pruritus; Pyrexia; Skin nodule	FLU3~CONNAUGHT LABORATORIES~4F51060~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068586	11/19/1994	KY	27.0	27		F	11/14/1994	pt had tingling of rt arm running down the arm vax was given in rt arm; had redness & edema of site also sent to MD w/referral & authorization for payment;				Y					Y	11/08/1994	11/09/1994	1		PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51087~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068587	11/19/1994	PA	58.0	58		M		pt recvd vax 1OCT94 & 11OCT94 onset of sx dark brown mass passed while urinating-no dysuria; testicular swelling; 11OCT94 pt to urologist-also had flu-like sxs; taking Cipro for 30 days;				Y					U	10/01/1994	10/11/1994	10	urinalysis;	PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Influenza; Oedema genital; Urine analysis abnormal	FLU3~PFIZER\WYETH~4948122~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0068588	11/19/1994	SC	60.0	60		M	11/08/1994	urticaria;				Y					U	11/07/1994	11/08/1994	1		PUB	OTH				~ ()~~~In patient		1						1	Urticaria	FLU3~PFIZER\WYETH~4948130~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0068591	11/19/1994	OH	36.0	36		F		extreme muscle soreness, entire cervical & thoracic vertebrae area; pain even trying to lift arm to bursh teeth; lt leg had numbness; pain woke pt 4AM next morning lasted 7 days exactly; no temp				Y					Y	10/18/1994	10/19/1994	1		PVT	OTH		NONE	NONE	~ ()~~~In patient		1						1	Back pain; Insomnia; Myalgia; Neck pain; Pain; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0068593	11/19/1994	WA	4.0	4		F	11/08/1994	21-22 hrs p/vax mom noted 4mm x 5mm area of blisters (3); area was red from upper deltoid down to elbow-tenderness; that evening pt vomited x 1 & had a low grade fever; mom called to report poss react to clinic; on exam healing scars noted;				Y					Y	11/04/1994	11/05/1994	1	NONE	PVT	PUB	Intal Aerobid	asthma-?bronchitis;	asthma	NONE~ ()~~~In patient		1						1	Dermatitis bullous; Pain; Pyrexia; Vasodilatation; Vomiting	FLU3~PARKE-DAVIS~00494P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0068597	11/19/1994	WI	61.0	61		M	11/14/1994	sharp pain (cramping) back, chest & stomach as of 830AM 13NOV94;									Y	11/11/1994	11/13/1994	2	NA	PUB	OTH	NA	NONE	NKDA	NA~ ()~~~In patient		1						1	Abdominal pain; Back pain; Chest pain	FLU3~CONNAUGHT LABORATORIES~4F51067~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068603	11/19/1994	NY	31.0	31		F	11/12/1994	for approx 2 days p/vax pt exp sore throat, weakness, myalgias, nasal congestion;									Y	10/28/1994	10/28/1994	0	NONE	PUB	OTH	Lithium, Zoloft, klonopin, Bromocriptune	major depression	depressive illness; pituitary adenoma	~ ()~~~In patient		1						1	Asthenia; Myalgia; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0068607	11/19/1994	OK	44.0	43		F	11/14/1994	woke up w/t102 @ 6AM 4NOV94 also had flu sx, achey all over, h/a; fever stayed 102 until 5NOV94 about 5PM; felt like had the flu for 3 full days p/shot;									Y	11/03/1994	11/04/1994	1	NONE	PVT	PVT	allergy shot		allergies	~ ()~~~In patient		1						1	Headache; Influenza; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~3~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0068608	11/19/1994	SD	31.0	31		M	11/14/1994	soreness @ site; tenderness @ site; dec mobility in joint; on ATB & pain medication receiving PT treatments;										10/26/1994	10/26/1994	0	unk-told had blood test;	OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Arthropathy; Hypokinesia; Injection site pain	FLU3~CONNAUGHT LABORATORIES~4F51006~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068755	11/21/1994	MO	60.0	60		F	11/10/1994	13OCT94 sudden onset w/chills of 6-7hrs duration followed w/sweating for about 1hr; total duration approx 8hrs; pt recovered;									Y	10/13/1994	10/13/1994	0	NONE	UNK	PUB	Cardizem, Glucotrol, Lotension, Thyroid	NONE	diabetes, hypertension	NONE~ ()~~~In patient	MO94097	1						1	Chills; Hyperhidrosis	FLU3~CONNAUGHT LABORATORIES~4F51160~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068767	11/21/1994	TN	62.0	62		F	11/03/1994	pt recvd vax on 18oct94;had no pain w/ inject but that noc, began having aching pain in axillary area;pain cont x 2wks;pain now goes from shoulder to just above Lt elbow;c/o hurting when lift an object or if raises arm above head;										10/18/1994	10/18/1994	0	none;	PUB	PUB	feorinal for h/a;	none;	none;	none;~ ()~~~In patient	TN94151	1						1	Injection site pain; Myalgia; Pain	FLU3~PFIZER\WYETH~4948116~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068768	11/21/1994	TN	56.0	56		F	11/09/1994	pt recvd vax on 2nov94 in am; that noc had red raised rash on both arms & on waist; rash, pruritic, warm to touch, sxs lasted 1 wk; lesion scabbed over, had h/a; no n; sinus infect w/ body aches;									Y	11/02/1994	11/02/1994	0	none;	PUB	PUB	synthroid; estrogen (premarin);	none;	allergy, ceclor; hypothyroidism;	none;~ ()~~~In patient	TN94152	1						1	Headache; Myalgia; Pruritus; Rash maculo-papular; Sinusitis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51023~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068770	11/21/1994	MO	54.0	54		F	11/16/1994	pt recvd vax;began having h/a on 8nov followed by pain in rt neck & shoulder; on 9nov had severe pain in the back &  legs w/ numbness in feet,toes & fingers;in ofc on 11nov w/ c/o numbness;pt referred to neurologist,poss dx of GBS;			Y		Y					11/01/1994	11/08/1994	7		PVT	PVT	zocor; robaxin; vicodin;	none;	hypercholesterolemia; post herpetic neuralgia;	~ ()~~~In patient		1						1	Back pain; Guillain-Barre syndrome; Headache; Neck pain; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51015~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0068771	11/21/1994	NY	44.0	44		F	11/15/1994	pt recvd vax; exp weakness from waist down, unable to walk w/out assistance; generalized body aches; t 101.1;				Y	Y	6			Y	11/01/1994	11/02/1994	1	3nov94 crx early rll pneumonia;	PVT	OTH			nka;	~ ()~~~In patient		1						1	Asthenia; Gait disturbance; Hypokinesia; Myalgia; Pneumonia; Pyrexia	FLU3~PFIZER\WYETH~4948131~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0068772	11/21/1994		79.0	79		F	10/27/1994	pt recvd vax; day following inject of flu, lt upper arm became extremely sore, swollen & red; swelling extended down to wrist;								Y		10/08/1994	10/08/1994	0		UNK	UNK				~ ()~~~In patient		1						1	Myalgia; Oedema peripheral; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0068774	11/21/1994	WI	30.0	30		F	11/02/1994	pt recvd vax; c/o itchy eyes, started about 11am; obvious hives; dizzy & mouth dry;				Y	Y	1			Y	11/02/1994	11/02/1994	0	final dx, duck embryo allergy;	OTH	OTH	none;	none;	pt had nka;	~ ()~~~In patient		1						1	Dizziness; Dry mouth; Hypersensitivity; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51060~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0068775	11/21/1994	WY	44.0	44		F	11/10/1994	2PM eyes red, mattered, burning, scratchy; chills/fever-q 2 hrs; nausea/vomiting/h/a, lethargy 12 hrs;				Y					Y	11/08/1994	11/08/1994	0	eye exam	PUB	PUB		NONE	NONE	~ ()~~~In patient		1						1	Chills; Conjunctivitis; Eye pain; Headache; Pruritus; Pyrexia; Somnolence; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51072~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068776	11/21/1994	NH	39.0	39		M		pt recvd vax; was pale, diaphoretic, unconscious for approx 1 1/2 mins; 90/60, P 52; semi conscious approx 6 mins; ears ringing; feels tired;				Y					Y	11/09/1994	11/09/1994	0	ekg w/in nl limits;	PUB	PUB	none;	denies	nka;	~ ()~~~In patient	NH94035	1						1	Asthenia; Bradycardia; Hyperhidrosis; Hypotension; Pallor; Stupor; Syncope; Tinnitus	FLU3~CONNAUGHT LABORATORIES~4F51016~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068778	11/21/1994	OH	7.0	7		M	11/15/1994	pt recvd vax;was at school when teacher said eyes went to back of head x 2; did not lose consciousness;did c/o extreme thirst all day after event; saw PMD at 2pm; afebrile, curried 4 days after immun;				Y					Y	11/07/1994	11/11/1994	4	none;	PUB	PUB	none;	none;	recurrent bronchitis w/ asthma;	~ ()~~~In patient		1						1	Gaze palsy; Thirst	FLU3~CONNAUGHT LABORATORIES~4F51072~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068779	11/21/1994	ME	36.0	36		F	11/10/1994	pt recvd vax;  swollen, red, hard & itchy; sauve & pills for itching; seen at hosp; clear up 7jul94;				Y					Y	10/31/1994	11/01/1994	1		PUB	UNK	atenol; aspirin;insulin-10 reg, 25 nph	allergic to pcn & sulfa	diabetic & heart condition;allergic to pcn & sulfa	~ ()~~~In patient		1						1	Oedema; Pruritus; Skin nodule; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51088~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068781	11/21/1994	MA	54.0	54		F	10/08/1994	pt recvd vax; cellulitis rxn w/in 24 hrs of vax w/ ecchymosis in ctr; raised, tender & heat; 3x4cm; rx dicloxacillin;				Y						10/07/1994	10/08/1994	1		PVT	PUB	ativan; premarin; MVI;	none;	alcerative colitis s/p ileostomy;	~ ()~~~In patient		1						1	Cellulitis; Ecchymosis; Injection site mass; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4948114~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0068782	11/21/1994	OH	59.0	59		F	11/02/1994	pt recvd vax; swelling in site, in lymph node under arm & all muscle in arm & in under arm w/ constant pain; unable to lift arm above head x 4 days;tx w/ warm compress; strong smelling urine;				Y					Y	10/24/1994	10/24/1994	0	urine specimen;	PVT	OTH	capozido; premarin;	none;	none;	none;~ ()~~~In patient		1						1	Hypokinesia; Injection site oedema; Lymphadenopathy; Oedema peripheral; Pain; Urine analysis abnormal	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0068784	11/21/1994	NY	40.0	40		F	11/16/1994	pt recvd vax; c/o feelingss of warmth, perspiration, shaking, tightness of diaphragm & throat; meds given by MD; Epi given at c/o sxs, ER visit				Y					Y	11/15/1994	11/15/1994	0		OTH	OTH	DPH;	none;	none;	~ ()~~~In patient		1						1	Chest pain; Hyperhidrosis; Laryngospasm; Tremor; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51006~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068788	11/21/1994	MA	46.0			M	11/04/1994	temp 102, gen aches, malaise									Y	11/02/1994	11/03/1994	1		PUB	PUB	unk	lt eye infect-skin rash	HIV+	~ ()~~~In patient		1						1	Malaise; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51015~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068789	11/21/1994	OR	86.0	86		F	11/17/1994	pt recvd vax; exp severe h/a; low fever; felt miserable; n at times; to MD on 3nov94; said several come in w/ flu like sxs w/ flu vax;									Y	10/19/1994	10/22/1994	3		PUB	UNK		none;		~ ()~~~In patient		1						1	Headache; Malaise; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0068791	11/21/1994	MN	80.0	80		F	11/18/1994	pt recvd vax; devel 4-5 days after inject small red area, now rash involves volar surface of upper arm from elbow to shoulder; warm raised path of erythema; itchy;									U	11/11/1994	11/15/1994	4	none;	PVT	UNK	HCTZ; vitamins;	none;	hypertension;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4948105~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~4F61059~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0068792	11/21/1994	CA	72.0	72		F	11/15/1994	pt recvd vax; devel bell's palsy;									U	10/19/1994	10/22/1994	3	none;	PVT	PVT	micronase; insulin; amitriptyline; qyinam; anoxin;		hypertension; allergic to pcn;	none;~ ()~~~In patient		1						1	Facial palsy	FLU3~PFIZER\WYETH~4948101~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068796	11/21/1994	CA	81.0	81		F	11/09/1994	pt recvd vax; pt became ill on sat eve around 6pm after flu shot on fri; got cold & shaky & achy; stayed in bed & is still not well today (31oct); though better than yesterday;									Y	10/28/1994	10/29/1994	1	none;	PVT	PVT	dyazide; mysoline;		hypertension;	~ ()~~~In patient		1						1	Chills; Malaise; Myalgia; Tremor	FLU3~PFIZER\WYETH~4948103~UNK~A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068797	11/21/1994	GA	52.0	52		M	11/14/1994	pt recvd vax; exp pain originating at inject site & radiating into Lt neck & shoulder; c/o weakness Lt arm; was afebrrile; tx ibuprofen; heat qid to area;									Y	11/03/1994	11/05/1994	2		OTH	OTH	none;	none;	bee stings;	~ ()~~~In patient		1						1	Injection site pain; Myasthenic syndrome; Neck pain; Pain	FLU3~PFIZER\WYETH~4948197~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068798	11/21/1994	FL	62.0	62		F		pt recvd vax; cellulitis in Rt arm; warm soaks;									Y	11/02/1994	11/04/1994	2		OTH	UNK	novadex; procardia;	none;	allergies: bactrim, codeine, IVP dye;	~ ()~~~In patient		1						1	Cellulitis	FLU3~PFIZER\WYETH~4948052~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068800	11/21/1994	NH	79.0	79		F	11/15/1994	flu vax given 25OCT94; black & blue 18 days rt arm;									Y	10/25/1994	10/26/1994	1		UNK	UNK				~ ()~~~In patient		1						1	Ecchymosis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0068802	11/21/1994	CO	80.0	80		F	11/15/1994	pt recvd vax;25oct94 pt's son called to state pt had swollen,red area around inject site;woke up this am w/ painful area; plan of tx, ice  pack x 24 hrs; DPH to dec itchy rxn; advil to dec inflammation/pain;									Y	10/24/1994	10/25/1994	1	neg;	PVT	PVT	prilosec; propulsed;	none;	dx scleroderma; hypertension; hypothyroidism; allergies: procardia (dizziness);	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site inflammation; Injection site oedema; Injection site pain; Pain	FLU3~CONNAUGHT LABORATORIES~4F51133~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~3849160~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0068804	11/21/1994	CO	80.0	80		F	11/15/1994	pt recvd vax on 2nov94; 4nov94 pt called w/ swelling from inject site to elbow; area red; warm to touch; no limp; plan tx: ice to area x 24 hrs; apap for discomfort; cleared in 24 to 48 hrs;									Y	11/02/1994	11/03/1994	1	neg;	PVT	PVT	premarin; tenormin; norpramine; haldol; cald; vicodin;	none;	dx sz disorders; tachycardia; no known allergies; not allergic to eggs;	none;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51133~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~384962~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0068805	11/21/1994	VA	50.0	50		F	11/08/1994	pt recvd vax 25oct94; next day inject site was red at 1 1/2 around site; at point of inject has raised 1/2x1/2 white spot; spot still fading 2 wks later; had aches, fever of 103 x 2 days;									Y	10/25/1994	10/26/1994	1	none;	PUB	PUB	vasotec; tagamet;diabeta		diabetes HTN; allergy to pcn, provera, PPD;	in pt, had same rxn to flu vax last year;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Myalgia; Pyrexia	FLU3~PARKE-DAVIS~374P~3~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0068807	11/21/1994	MI	67.0	67		F	10/05/1994	pt recvd vax; quarter size swollen welt at inject site immediatly p/ vax; pt given ice pack & DPH po;									Y	10/05/1994	10/05/1994	0		PVT	PVT	glucatrol;	none;	diabetes, hypothyroidism;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PARKE-DAVIS~00474P~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0068808	11/21/1994	MI	25.0	25		F	10/14/1994	pt recvd vax; red 2 side to side; 1 from top to bottom around area where inject was given; feels fine;										10/13/1994	10/14/1994	1		PVT	OTH	insulin;	none;	none;	none;~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~00474P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0068809	11/21/1994	MI	70.0			F	10/24/1994	pt recvd vax; red swollen, not at inject site; size of 50 cent piece;									Y					PVT	OTH		none;	none;	none;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PARKE-DAVIS~00474P~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0068866	11/22/1994	AK	54.0	54		M	10/11/1994	pt recvd vax 10OCT94 that evening awoke w/sweating & pain & swelling in lt upper arm; seen in clinic again 11OCT94 redness & swelling 5 x 7 in lt upper arm, dec mobility in upper arm; t99.6; referral to primary hlth provider;				Y						10/10/1994	10/10/1994	0		PUB	PUB		NONE		~ ()~~~In patient	AK94014	1						1	Hyperhidrosis; Hypokinesia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51165~5~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0145A~2~~LA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~4E61168~1~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0068867	11/22/1994	AK	58.0	58		F	10/27/1994	c/o soreness to flu vax site; area red about 3 in length, 1 1/2 side, area warm, some itching;				Y					Y	10/13/1994	10/23/1994	10	CBC	PVT	OTH	Claritin, Vncenase	chronic low grade sinusitis,low back pai	allergy PCN; hx of reac to vax from childhood; doesn't know date or type	pt exp local react 4-6? pt does not know type or date;~ ()~~~In patient	AK94015	1						1	Injection site hypersensitivity; Injection site pain; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51023~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068868	11/22/1994	AK	69.0	69		F	10/17/1994	arm pain began immediately; hurt from shoulder to elbow; next day awoke w/aching in joints-hips, fingers, knees; fatigue, sleepy, felt chilled; since then still feels not self, low energy;									N	10/13/1994	10/13/1994	0	NONE	PUB	PUB	Synthyroid	NONE	thyroid	pt's mother exp delirious for days during WWII w/smallpox vax;~ ()~~~In patient	AK94028	1						1	Arthralgia; Asthenia; Chills; Pain; Personality disorder; Somnolence	FLU3~CONNAUGHT LABORATORIES~4F51023~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068869	11/22/1994	AK	9.0	9		F	10/24/1994	pt recvd vax & mom reports pt went skating then 1 hrs p/inject c/o itching on feet; devel rash & joint pain;  25OCT devel joint pain in hip-that could not even walk;				Y						10/21/1994	10/21/1994	0	NONE	PUB	PUB	Suprax, Seldane, Naso-cort spray (nasal);	no temp elevation-rx for sinus infect	pt is deaf	NONE~ ()~~~In patient	AK94029	1						1	Arthralgia; Condition aggravated; Gait disturbance; Hypokinesia; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~4F5103~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068870	11/22/1994	AK	56.0	56		F	10/27/1994	pt recvd shot in AM went home napped for awhile; got up to do some dishes found self on the floor; had breast lump removed last Thursday 20OCT94;									Y	10/25/1994	10/25/1994	0	NONE	PUB	UNK		recently had surgery		~ ()~~~In patient	AK94018	1						1	Syncope	FLU3~CONNAUGHT LABORATORIES~4F51165~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068871	11/22/1994	AK	37.0	37		F	11/04/1994	nausea, tired & sleepy, large wheal on arm which was hot to touch; tingling infingers, aching all over; arm swollen; wheal approx 2 diameter;				Y					Y	11/02/1994	11/02/1994	0	NA	PUB	PUB		NONE	NONE	~ ()~~~In patient	AK94031	1						1	Asthenia; Myalgia; Nausea; Oedema peripheral; Paraesthesia; Somnolence; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51023~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068873	11/22/1994	WI	40.0	39		F	11/07/1994	arm sore, itchy, swollen (baseball size), body aches, weakness, n/v, diarrhea, chest pain, SOB; took DPH helped SOB, itching; cont sl weak;									Y	11/02/1994	11/02/1994	0	NONE	PUB	PUB		NONE	PCN, Cortisone, diarrhea from eggs;	~ ()~~~In patient	WI94083	1						1	Asthenia; Chest pain; Diarrhoea; Dyspnoea; Myalgia; Oedema peripheral; Pruritus; Vomiting	FLU3~PFIZER\WYETH~4948033~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068874	11/22/1994	WI	51.0	51		F	10/11/1994	11OCT94 the rt arm pit began to swell-on 12OCT94 the armpit area became quite swollen, painful & hurt; no reddness or itching; pt seen by MD 13OCT94; the swelling subsided-recommended not recvd a flu shot next year;				Y					Y	10/11/1994	10/11/1994	0		PUB	PUB		NONE		~ ()~~~In patient	WI94084	1						1	Oedema; Pain	FLU3~CONNAUGHT LABORATORIES~4F51165~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068876	11/22/1994	WI	69.0	69		M	11/08/1994	rt arm swollen, sore, red, weakness, SOB, couldn't move arm; taken to clinic 845AM inc wheezing, extreme weakness, SOB-transferred to hosp from clinic @ 1115AM by rescue squad; given 02, IV DPH @ hosp;				Y	Y	1			Y	11/02/1994	11/03/1994	1	chem panel-lab;	PUB	UNK	Vasotec, Cardarone, Lenoxin, Arcriptin	NONE	allergic to Inderal & Tenormin; CAB-79-90;	NONE~ ()~~~In patient	WI94086	1						1	Asthenia; Asthma; Dyspnoea; Hypokinesia; Myalgia; Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51016~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0536A~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0068879	11/22/1994	WI	48.0	48		F	10/24/1994	430AM had status asthmaticus w/laryngospasm; was taken to hosp ICU;			Y	Y	Y				Y	10/20/1994	10/21/1994	1		PVT	PUB	Inhalers, Theophylline, Pred	NONE	asthma, Laryngospasms in past	~ ()~~~In patient	WI94090	1						1	Asthma; Condition aggravated; Laryngospasm	FLU3~PARKE-DAVIS~01764P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation	Influenza
0068882	11/22/1994	WI	66.0	65		F	10/27/1994	pain @ inject site immed p/vax; pain worse & radiated back of arm & to breast area; by that evening an orange sized swollen area has devel in upper arm, hot to touch; applied cold packs; that noc noticed an ecchymosis & 8 hive like lesions;				Y					Y	10/17/1994	10/17/1994	0	NONE	PUB	PUB	Lozol, ASA, Zestril	NONE	PCN in allergy-sensitive to lots of things-didn't know names of meds;	NA~ ()~~~In patient	WI94099	1						1	Breast pain; Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pain; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51165~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0536A~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0068887	11/22/1994	NJ	40.0	40		F	11/14/1994	serum sickness, fever; petechiae; asthma; abn LFT's, asthma excerbation; exacerbation crohn's;			Y		Y	8	Y		Y	10/28/1994	10/29/1994	1	ESR 68; Abn LFT's; 36 BANDS;	PVT	PVT	asa; ASACOL; rowasa;  Proventil; Prilosec; Carafate; Intal;	Crohn's; asthma; Lyme;	crohn's, asthma,lyme	NONE~ ()~~~In patient		1						1	Condition aggravated; Hepatic function abnormal; Petechiae; Pyrexia; Red blood cell sedimentation rate increased; Serum sickness	FLU3~PARKE-DAVIS~01764P~2~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation	Influenza
0068891	11/22/1994	CA	19.0	19		M	11/14/1994	w/in 90 seconds of vax felt lightheaded but w/in a few mins became dizzy, pale (white) & diaphoretic w/some difficulty breathing; Nurse attempted to check BP & cuff didn't work; called 911 administered 1 ml of Epi; BP 128/72; pulse non palp				Y					Y	11/12/1994	11/12/1994	0	unk	PUB	PVT		NONE	unk	~ ()~~~In patient		1						1	Asthenia; Cardiovascular disorder; Dizziness; Dyspnoea; Hyperhidrosis; Pallor; Tremor	FLU3~PFIZER\WYETH~4948068~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0068893	11/22/1994	NY	49.0	49		F	11/09/1994	p/approx 2 mins pt c/o warm flush in face & tightening both jaws, sl difficult breathing; BP 120/80, pulse 68/radial/reg, strong, called 911; exp sl nausea; 911 canc @ pt's request;				Y					Y	11/09/1994	11/09/1994	0		UNK	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Dyspnoea; Hypertonia; Nausea; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51067~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068896	11/22/1994	CO	55.0	55		M	11/14/1994	22OCT94 AM noticed couldn't use mouth very well, couldn't wrinkle nose or wink eye (all on rt side of face); seen by MD 23OCT dx Bell's Palsy; 26OCT94 seen by MD- tx Pred; MD also noticed herpes-like lesion in outer ear canal rt side				Y					N	10/21/1994	10/22/1994	1	lyme=neg; blood glucose=nl; sl elevation of thyroid function;	OTH	OTH	isoptin; Mevacor; Zesteretic	high blood pressure;	bee sting allergy, high blood pressure;	NONE~ ()~~~In patient		1						1	Facial palsy; Hyperthyroidism; Skin ulcer	FLU3~PFIZER\WYETH~01764P~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0068899	11/22/1994	MA	49.0	49		M	11/14/1994	aching-muscle soreness-pressure in head-h/a lower abdo cramping;				Y					Y	11/02/1994	11/03/1994	1	NONE	PVT	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						1	Abdominal pain; Headache; Myalgia	FLU3~CONNAUGHT LABORATORIES~4F51025~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068900	11/22/1994	NY	27.0	27		F	11/11/1994	pt c/o swelling lt side of jaw/ear & sl to lt side of face; tightness of chest, palpita; also CP & back pain w/SOB; VS P100 observed to have flushing to face;				Y					Y	11/01/1994	11/01/1994	0	lungs clear; heart sounds reg;	OTH	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						1	Back pain; Chest pain; Dyspnoea; Face oedema; Palpitations; Tachycardia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51025~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068901	11/22/1994	CA	49.0	49		F	11/15/1994	p/inject returned w/lightheadedness, double vision & hand numbness; BP 160/100; hives @ site 13OCT94 inc BP 160/100- 164/80R, 144/92 L; speech still funny; induration 3 diameter lt upper arm; tx Seldane;				Y					Y	10/11/1994	10/11/1994	0		PVT	PVT	Seldane	NONE	allergic: codeine, Sulfa, DPH, Decongestants, Antihist	~ ()~~~In patient		1						1	Diplopia; Dizziness; Hypertension; Injection site hypersensitivity; Injection site mass; Paraesthesia; Speech disorder	FLU3~PFIZER\WYETH~4948031~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0068902	11/22/1994	CA	59.0	59		F	11/14/1994	pt recvd vax & the pain travelled up neck to head; had pain for several (3) days p/including soreness of the lt arm, neck, shoulder, sniffles, diarrhea & generally all over lousy weekend dragging self around until Monday 17OCT94;									Y	10/14/1994	10/14/1994	0		PUB	PVT		NONE	NONE	NONE~ ()~~~In patient		1						1	Diarrhoea; Headache; Malaise; Myalgia; Neck pain; Pain; Rhinitis	FLU3~PFIZER\WYETH~4948044~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068904	11/22/1994	MA	2.0	2	.5	F	11/10/1994	hives for 1 day p/flu shot, disappear p/DPH; pt vomited once or twice a day for 6 days;									Y	11/01/1994	11/01/1994	0	NONE	PVT	PUB	Ventolin, Robitussin DM	bronchitis	bronchial asthma	~ ()~~~In patient		1						1	Urticaria; Vomiting	FLUX~UNKNOWN MANUFACTURER~4F51113~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0068905	11/22/1994	NJ	62.0	62		F		watering eyes & nose; 3rd day coughing up green mucos; congestion & cold for 1 1/2 wk; aching legs & ankles, sore throat;									Y	11/03/1994	11/04/1994	1		OTH	OTH		NONE		~ ()~~~In patient		1						1	Arthralgia; Cough; Lacrimal disorder; Myalgia; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0068910	11/22/1994	SC	34.0	33		M	11/16/1994	right low jaw numbness tingling w/dry mouth resolved w/in 1 hr;									Y	10/27/1994	10/27/1994	0	NA	MIL	MIL	NONE	NONE	Ramsey Hunt synd-SEP93 rt face	~ ()~~~In patient		1						1	Dry mouth; Paraesthesia oral	FLU3~PARKE-DAVIS~00284P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0068911	11/22/1994	WI	61.0	61		F	11/17/1994	started w/nasal congestion; pressure/pain face; laryngitis; cough-non productive; dec grade temp/chills; dx sinusitis pharyngitis;									Y	11/07/1994	11/10/1994	3	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Chills; Cough; Laryngitis; Pain; Pharyngitis; Pyrexia; Rhinitis; Sinusitis	FLU3~PARKE-DAVIS~01564P~4~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~382958~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0068912	11/22/1994	IL	3.0	3		F	11/10/1994	pt recvd vax 9NOV94 in AM; pt woke w/fever 102 during noc & c/o nausea; fever down by 10NOV daytime;									Y	11/09/1994	11/10/1994	1	NONE	PVT	PVT	NONE	nasal congestion	rt OM 24OCT94; resolved by exam on 9NOV94;	~ ()~~~In patient		1						1	Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51069~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068913	11/22/1994	GA	48.0	48		F	11/16/1994	pt recvd vax 7NOV04 & sx began 11NOV94, rash, wheals all over body including palms of hands & soles of feet; itchy; DPH given;									Y	11/07/1994	11/11/1994	4	CBC & Urinalysis done by pvt MD results nl;	OTH	UNK		NONE	pollens, grasses, molds, dusts, fungus, grains, shell fish, iodine, milk	NONE~ ()~~~In patient		1						1	Pruritus; Rash; Urticaria	FLU3~PFIZER\WYETH~4948197~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068914	11/22/1994	MO	40.0	40		F	10/11/1994	chills, fever up to 103, vomited x 1, aching, course 3 days;									Y	10/06/1994	10/06/1994	0	NA	PVT	PVT	NONE	NONE	allergic-PCN	pt's sibling had flu sx in 1984 w/flu;~ ()~~~In Sibling		1						1	Chills; Myalgia; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51158~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0059885	11/23/1994	CA				M	11/10/1994	pt recvd vax 30oct93; w/in approx 1 wk, devel GBS;					Y				N	10/30/1993	11/01/1993	2		PVT	PVT				~ ()~~~In patient	894318007K	1						2	Guillain-Barre syndrome; Guillain-Barre syndrome	FLUX~PFIZER\WYETH~4938148~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0068916	11/23/1994	OH				F	11/07/1994	pt recvd vax 1nov94, devel malaise,on nov694 devel confusion & fever;admitted to hosp & underwent lumbar puncture which showed lymphocytic pleocytosis;tx w/atb/acyclovir,bacterial & viral cultures are pending;improved as of 8nov94;					Y				Y	11/01/1994	11/06/1994	5	lymphocytic pleocytosis on lumbar puncture; cxs: no growth;	OTH	OTH		unk;		~ ()~~~In patient	894312002K	1						1	CSF test abnormal; Confusional state; Malaise; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0068920	11/23/1994	MA	67.0	67		F	11/07/1994	pt recvd vax; devel 4x2cm; swollen;itchy; bright red spot; had same condition last year;									Y	10/26/1994	10/27/1994	1		UNK	UNK				~ ()~~~In patient	MA9428	1						1	Oedema; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51165~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068921	11/23/1994	MA	57.0	57		F	11/15/1994	pt recvd vax; exp shortness of breath & pressure on chest -> 5 hrs; swelling of eyelids->48 hrs;pt states used to be allergic to eggs;presently eat eggs but has mult allergies;									Y	11/14/1994	11/14/1994	0	none;	PUB	PUB		none known;	?egg allergy;	~ ()~~~In patient	MA9429	1						1	Chest pain; Dyspnoea; Face oedema	FLU3~CONNAUGHT LABORATORIES~4F51025~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068924	11/23/1994	MD	60.0	60		M	11/17/1994	pt recvd vax 25oct94;noted some local gum bleeding eve 4nov;gum bleeding all night of 7nov; hosp 8nov;platelet count of only 4000/ml; bone marrow test shows production okay;preliminary dx IPT;placed on predisone;count rebuilding 16,000/ml;				Y	Y					10/27/1994	11/04/1994	8		UNK	UNK				devel type 2 diabetes in dec93 about 1 mo after similar flu shot;tx successfully~ ()~~~In patient		1						1	Gingival bleeding; Thrombocytopenia; Thrombocytopenic purpura; Condition aggravated; Gastrointestinal haemorrhage; Gingival bleeding; Immune system disorder; Thrombocytopenia; Thrombocytopenic purpura	FLU3~PFIZER\WYETH~4948197~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4948197~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0068925	11/23/1994	CA	82.0	82		F	11/17/1994	pt recvd vax; was unable to walk; dx r/o MI; hx of HTN DM;					Y					11/10/1994				UNK	UNK			allergies to pcn;	~ ()~~~In patient		1						1	Coordination abnormal; Gait disturbance; Hypokinesia; Myocardial infarction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0068930	11/23/1994	NY				F	11/16/1994	pt recvd vax; exp general body malaise x 3 days, progressively got worse then got better; low grade fever; chills & cold sweats;									Y	11/02/1994	11/02/1994	0	dec wbc; 4nov94 returned to nl;	OTH	PUB	none;	none;	allergic to smallpox;	~ ()~~~In patient		1						1	Chills; Hyperhidrosis; Leukopenia; Malaise; Pyrexia	FLU3~PFIZER\WYETH~4948191~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068438	11/25/1994	VA	41.0	41		F	11/11/1994	fever next morning pain in arm progressing to shoulders & arm pain by Saturday morning; fever reaching 102; rash on arm @ inject site; cellulitis dx @ ER on Saturday morning; Erythromycin prescribed @ ER;				Y					Y	10/26/1994	10/27/1994	1	WBC-17.5	PUB	PUB	NONE	cold	allergic to Keflex, Lomotil, PCN, Tetracycline; dx degenerative disc disease	~ ()~~~In patient	VA94082	1						2	Injection site hypersensitivity; Injection site pain; Malaise; Pyrexia; Rash; Cellulitis; Injection site hypersensitivity; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51006~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~384961~UNK~A~~PNEUMO (PNU-IMUNE)~1|FLU3~CONNAUGHT LABORATORIES~4F51006~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~384961~1~IM~RA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0068934	11/25/1994	OH	35.0	35		F	11/08/1994	pt recvd shot 9AM sx of rash on trunk of body extended to arms started @ 230PM same day-runny nose & itchy throat @ 1130AM-MD called ordered DPH; rash dec by 8PM 3 circle redness & warm @ site;									Y	11/03/1994	11/03/1994	0	NONE	PUB	PUB	Synthroid	NONE	NONE	~ ()~~~In patient	OH94103	1						1	Injection site hypersensitivity; Pharyngitis; Rash; Rhinitis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51055~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068935	11/25/1994	OH	50.0	50		F	11/08/1994	muscular soreness; deep soreness; no swelling-hard to lift arm-took APAP w/no relief; told to call MD try heat & APAP again;									N	10/31/1994	10/31/1994	0	NONE	PUB	PUB	Monthly allergy shot; Birth control		allergy to tetanus toxins 1972	pt has allergy to tetanus @ 28 y/o; pt sibling exp chills & flu-like sx @ 44y/o~ ()~~~In patient	OH94104	1						1	Hypokinesia; Myalgia	FLU3~CONNAUGHT LABORATORIES~4F51055~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068938	11/25/1994	SD	56.0	56		F	11/11/1994	felt jittery & hot 1 hr p/inject; later in the evening devel t102 oral; rash on neck, palms, itching; aching, fever blisters developed 24 hrs p/vax;									Y	11/09/1994	11/09/1994	0		PVT	PVT				~ ()~~~In patient	SD94036	1						1	Mouth ulceration; Myalgia; Nervousness; Pruritus; Pyrexia; Rash	FLU3~PFIZER\WYETH~4948042~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068939	11/25/1994	UT	43.0	43		F	11/07/1994	2hrs p/vax, pt started to have soreness in shoulder joint 2 hrs p/vax; around 630-7PM began to have difficulty breathing; took 2 DPH & relief occured 30 mins later; slept-no problems; awoke w/feeling of itching around abdo;no rash noted.									Y	11/04/1994	11/04/1994	0	NONE	PUB	PUB	NONE	NONE	allergy-Demerol, Morphine	~ ()~~~In patient	UT941825	1						1	Arthralgia; Dyspnoea; Pruritus	FLU3~CONNAUGHT LABORATORIES~4F51071~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068942	11/25/1994	PA	72.0	72		M	11/21/1994	profound sensorineural hearing loss & vertigo 2 days following flu shot;								Y	N	10/10/1994	10/14/1994	4	audiogram-MRI	UNK	UNK				~ ()~~~In patient		1						1	Deafness; Vertigo	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0068943	11/25/1994	PA	46.0			F	11/21/1994	profound sensorineural hearing loss & tinnitis 2 days p/flu vax;								Y	N				audiogram-MRI	OTH	UNK				~ ()~~~In patient		1						1	Deafness; Tinnitus; Deafness; Tinnitus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Disabling	Influenza
0068944	11/25/1994	PA	76.0	76		F	11/21/1994	pt collapsed in kitchen-ambulance arrived pt in vent fib-coded-died; flu vax given 16NOV & pt died 17NOV;	Y	11/17/1994							N	11/16/1994	11/17/1994	1	rhythm strip-Vf	PVT	PVT	Coumadin; Maxzide	NONE	NKDA; DMII, CHF, hypertension, Hypertriglyceridonic	NONE~ ()~~~In patient		1						1	Shock; Ventricular fibrillation	FLU3~CONNAUGHT LABORATORIES~4F51010~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0068948	11/25/1994	MA	31.0	31		F	11/21/1994	difficulty breathing dec B/S both lungs; BP 130/110-88 c/o vertigo; face flushed; watery eyes & nose; no relief & inhaler & rest taken to ER;				Y					Y	11/15/1994	11/16/1994	1		PUB	UNK	allergy inject	well	asthmatic	~ ()~~~In patient		1						1	Dyspnoea; Hypertension; Lacrimal disorder; Rhinitis; Vasodilatation; Vertigo	FLU3~CONNAUGHT LABORATORIES~4F51015~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068954	11/25/1994	CO	23.0	23		F	11/18/1994	4PM recvd flu shot; 8AM sudden onset stiff neck & numbness & tingling lt hand; which cont today				Y					U	11/17/1994	11/17/1994	0	NONE	OTH	OTH	Ortho Novum	NONE	Codeine	~ ()~~~In patient		1						1	Nuchal rigidity; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51055~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068957	11/25/1994	VA	54.0	53		F	11/19/1994	1 day p/flu vax pt devel itchy rash on neck, arms, abdo; pt seen by another MD & was given Kenolog & seldane;				Y						11/09/1994	11/10/1994	1		PVT	UNK				~ ()~~~In patient		1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~4F51021~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068961	11/25/1994	LA				M	11/04/1994										U	11/03/1994				OTH	UNK		NONE	allergic to Thimersol			1						1	Unevaluable event	FLU3~CONNAUGHT LABORATORIES~4F51055~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068963	11/25/1994	WI	54.0	54		F	11/23/1994	sl leakage of blood from lt nipple for 4 days; same thing happened last year; This nipple is inverted & often has a sl clear discharge which gets crusty; It was biopsied once but nothing found;									Y	10/25/1994	10/26/1994	1		PUB	PVT	Plaquinil, Synthroid	NONE	lupus, rheumatoid arthritis	pt exp blood from lt nipple @ 53 y/o w/flu vax~ ()~~~In patient		1						1	Haemorrhage	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0068965	11/25/1994	ME	17.0	17		M	11/10/1994	broke out in generalized hives immed p/adm of vax @ site & on abdo;									Y	10/21/1994	10/21/1994	0	NONE	PVT	PVT		NONE	Amocil, Ceclor, Bactrim, cheese, corn oats, lima beans, peanuts, tomatoes, seafood, milk, beesting, x-ray dyes	~ ()~~~In patient		1						1	Injection site hypersensitivity; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51145~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068972	11/28/1994	GA	65.0	65		F	10/21/1994	pt recvd vax on 13oct94; initial hosp date unk; hosp transfer 20oct for streptococcal sepsis; IV atbs adm; pt stable 21oct; organism being verified by microbiology lab; serotype pending; H/O bone marrow transplant for lymphoma;					Y				U	10/13/1994	10/16/1994	3	BC; streptococcus pneumoniae; serotype pending;	PVT	OTH	na;		bone marrow transplant (autologous)  for lymphoma;	na;~ ()~~~In patient	940220001	1						1	Infection; Sepsis	FLU3~CONNAUGHT LABORATORIES~4F51141~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~372977~1~IM~~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0068977	11/28/1994	MA	47.0	46		F	11/11/1994	pt recvd vax;w/in 3-4 hrs after,devel progressive conjunctival inject;lid swelling,tearing of eyes & retroorbital pain;by 5 hrs exp chills & then t of 100.7;sxs remained severe for 8-10 hrs;slept x 12 hrs;mild soreness at site;better w/ DPH									Y	11/04/1994	11/04/1994	0	none;	PVT	PUB	none;	none;	allergy to pcn; vancomycin;	~ ()~~~In patient	MA9431	1						1	Chills; Conjunctivitis; Face oedema; Headache; Injection site pain; Lacrimal disorder; Pyrexia; Somnolence	FLU3~CONNAUGHT LABORATORIES~4F51059~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068978	11/28/1994	MA	43.0	43		F	11/15/1994	pt recvd vax; exp t of 100.5 after few hrs;very red eyes for 24 hrs; had blurred vision because of mucous & a very grainy feeling in my eyes; mild soreness in inject site;next day, eyes still red but much milder; conjunctival, eyes hurted ;									Y	11/02/1994	11/03/1994	1	none;	OTH	PUB	none;	none;		~ ()~~~In patient	MA9432	1						1	Amblyopia; Conjunctivitis; Eye disorder; Eye pain; Injection site pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51059~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068979	11/28/1994	MA	74.0	74		F	11/17/1994	pt recvd vax; c/o heavyness in chest; c/o lump in throat; c/o h/a; c/o full headed feeling & cough;									Y	11/16/1994	11/16/1994	0	none;	UNK	PUB		none;	none;	~ ()~~~In patient	MA9433	1						1	Chest pain; Cough; Headache; Laryngospasm	FLU3~CONNAUGHT LABORATORIES~4F51025~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068980	11/28/1994	MS	48.0	48		F	11/18/1994	pt recvd vax & c/o pain,erythema & edema at inject site that pm; 7 x 3.5cm of erythema Lt deltoid;25cents purple bruised area Rt posterior & 5 cents purplelish area just below;aux nodes neg;no fever;some lethargy;no itching;									Y	11/17/1994	11/17/1994	0		OTH	PUB	tenormin; premarin; fiorinal w/ codeine;	some sl depression since dad death	none;	na;~ ()~~~In patient	MS94062	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain; Skin discolouration; Somnolence	FLU3~PARKE-DAVIS~016642~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0068981	11/28/1994	NC	74.0	74		F	11/10/1994	pt recvd vax; throat was sore & closed up about 2-3 hrs after inject; no dyspnea then approx 2 hrs later, exp dizziness; diaphoretic; faintness;				Y					Y	11/09/1994	11/09/1994	0		PUB	PUB	chlorrimeton;	allergic rhinitis;	s/p carotid endardarectomy;	~ ()~~~In patient	NC94129	1						1	Dizziness; Hyperhidrosis; Laryngospasm; Pharyngitis	FLU3~PARKE-DAVIS~02894P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0068983	11/28/1994	OH	33.0	33		F	11/02/1994	pt recvd vax; felt dizzy after sitting in waiting area;allergic to chickens,got shakey;paramedics started O2 + IV; to er;pt said chest felt heavy;given epi; dx poss anaphyletic rxn,prob anxiety attack;				Y					Y	10/31/1994	10/31/1994	0		PUB	PUB		prev. viral sinus infect;	none per MD; (allergic to chickens per box 7);	in pt, not sure, vaguely remembers rxn to a shot as a child;~ ()~~~In patient	OH94113	1						1	Anaphylactoid reaction; Anxiety; Chest pain; Dizziness; Tremor	FLU3~CONNAUGHT LABORATORIES~4F51016~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068984	11/28/1994	OH	57.0	57		F	11/17/1994	pt recvd vax; Lt deltoid area felt sore; has erythema at inject site 3x2; enduration w/ sl elevation; 15nov94 felt warm that evening & thru nite;									Y	11/15/1994	11/17/1994	2	none;	PUB	PUB	calan; provera; lozal;	none;	inc BP; TB pos rxn;	~ ()~~~In patient	OH94114	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51026~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068988	11/28/1994	OK	60.0	59		F	10/12/1994	pt recvd vax; paresthesia rt arm & edema of tongue immediately; BP 205/110; dx angiodema; rx decadron IM stat & prednisone PO next wk; BP down next day;			Y	Y					Y	10/10/1994	10/10/1994	0	none;	PUB	PUB		sjogren's;	mult allergies;	~ ()~~~In patient	OK9464	1						1	Angioneurotic oedema; Hypertension; Paraesthesia; Tongue oedema	FLU3~MEDEVA PHARMA, LTD.~E2504GC~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening	Influenza
0068995	11/28/1994	SD	35.0	35		F	10/19/1994	pt recvd vax; Rt arm swelling, reddened, blotchy elbow area; red streaks in Rt axilla;									Y	10/12/1994	10/14/1994	2		PVT	UNK		none;	none;	in pt, adverse event sulfa;~ ()~~~In patient	SD94027	1						1	Oedema peripheral; Rash maculo-papular; Skin striae; Vasodilatation	FLU3~PFIZER\WYETH~4948126~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~380958~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0068996	11/28/1994	SD	58.0	57		M	11/04/1994	pt recvd vax; hives began 8 hr post inject; Mond recvd shot of pcn & broke out very red w/ hives; given IV meds;				Y					Y	10/27/1994	10/27/1994	0		PUB	OTH		maybe a little run down;	na;	~ ()~~~In patient	SD94028	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51025~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0068997	11/28/1994	SD	42.0	42		M	11/04/1994	pt recvd vax; burning in lungs; burning in throat; difficulty swallowing, malaise, swollen tongue w/ lumps;									Y	10/27/1994	10/27/1994	0		PUB	UNK	none;	none;	none;	~ ()~~~In patient	SD94029	1						1	Chest pain; Dysphagia; Malaise; Pharyngitis; Skin nodule; Tongue oedema	FLU3~CONNAUGHT LABORATORIES~4F51025~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068998	11/28/1994	SD	49.0	49		M		pt recvd vax;pt reported soreness in Rt arm following vax in Rt deltoid; pain worsened over next 2 wks & was worst in 3rd wk;pain had since subsided;2 visits to chiropracter who reported rotater cuff injury;				Y					Y	10/24/1994	11/25/1994	32		PUB	PUB	none;	none;	phenothiazine;	~ ()~~~In patient	SD94030	1						1	Myalgia; Pain; Tendon disorder	FLU3~CONNAUGHT LABORATORIES~4F51016~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069000	11/28/1994	SD	42.0	42		F	11/15/1994	pt recvd vax; onset of sneezing, watery blood shot eyes; chills; fever & breathing difficulty;									Y	10/28/1994	10/28/1994	0		PUB	PUB	synthroid; klonopin;		h/as, thyroid problems;	~ ()~~~In patient	SD94033	1						1	Chills; Conjunctivitis; Dyspnoea; Lacrimal disorder; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~4F51025~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069001	11/28/1994	SD	50.0	50		F	11/15/1994	1NOV94 445PM onset of sore arm, leg pain; 2NOV94 2AM devel cramps, blood shot eyes & achiness;									Y	11/01/1994	11/01/1994	0		PUB	UNK	sulfasasalazine bustar	NONE	ulcerative colitis, allergic to PNC & Negram	~ ()~~~In patient	SD94034	1						1	Conjunctivitis; Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~4F51025~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069002	11/28/1994	SD	46.0	46		F	11/02/1994	pt reports had constriction of throat, flushing face, swelling eyes 3 hrs p/flu vax; pt contacted ask a nurse by phone was referred to pharmacist & poison ctrl ctr; all recommended pt seek ER tx by MD; pt declined; also chills, t101, flu sx									Y	10/28/1994	10/28/1994	0	NA	PUB	PUB	NA	NONE	antihistamines including DPH	NA~ ()~~~In patient	SD94035	1						1	Chills; Face oedema; Influenza; Laryngospasm; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51024~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069003	11/28/1994	CA	63.0	63		M	11/17/1994	hypertensive pt in a study for autonomic testing recvd flu vax & devel sx of atrial flutter;					Y					11/16/1994	11/16/1994	0	EKG showed atrial flutter	UNK	UNK	ACE inhibitors; Amylnitrite, Phenylephrine, Yohenebrae, Fosinpril	hypertension	hypertension	~ ()~~~In patient		1						1	Atrial flutter; Electrocardiogram abnormal	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0069010	11/28/1994	IL	59.0	58		F		chills, runny nose, ach y bones, eyes bloodshot for 2 days;				Y					Y	10/24/1994	10/26/1994	2		PVT	PVT	Darvocet-N 100	NONE	sulfa, PCN, Iodine, COmpazine, Hydergine	~ ()~~~In patient		1						1	Bone pain; Chills; Conjunctivitis; Rhinitis	FLU3~PFIZER\WYETH~4948033~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0069013	11/28/1994	NJ	57.0	57		F	11/23/1994	lt arm became painful next morning,got progressively worse until 2NOV94 PM when pain became excruciating & inability to lift arm started; seen by MD 3NOV94; MD felt tendon was infiltrated w/vax;began to move arm 6nov94;				Y					Y	10/31/1994	11/01/1994	1		PUB	OTH	Thyroid, folic acid	NONE	ITP	NA~ ()~~~In patient		1						1	Hypokinesia; Pain; Tendon disorder	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0069015	11/28/1994	CO	56.0			F	11/23/1994	pt recvd vax 22OCT94; 6 days later devel red inflammed hands & wrist eventually spread to lower trunk & legs; given topical hydrocortisone & cold compresses;				Y					Y	10/22/1994	10/28/1994	6	NA	OTH	PVT	NONE	NONE	amoxicillin, sulfa, Indocin	~ ()~~~In patient		1						1	Arthritis; Vasodilatation; Oedema peripheral; Pruritus; Rash; Rash maculo-papular; Vasodilatation	FLU3~PFIZER\WYETH~4948145~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4948145~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0069016	11/28/1994	AZ	45.0	45		F	11/17/1994	hard swelling occurred @ site immed; pt returned to work, called husband 15-20 mins later c/o redness, swelling, itching; husband advised DPH, ice arm;p/ 1 hr,sxs cont,felt hot,neck/chest red;to clinic,tx w/ dph;									Y	11/17/1994	11/17/1994	0	NONE	PUB	PUB		flu sx, mild, 1 week ago	none;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Oedema; Pruritus; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4948148~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0069017	11/28/1994	UT	49.0	49		F	11/21/1994	puffy & mattered eyes; chest tightness & dyspnea, hives, general malaise, cough sx started w/in 3 hrs & lasted about 36 hrs; hives started @ about 24 hrs;									Y	11/07/1994	11/07/1994	0		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Chest pain; Cough; Dyspnoea; Eye disorder; Face oedema; Malaise; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51071~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069018	11/28/1994	WY	57.0	57		M	11/21/1994	48 hrs p/vax pt devel stiff neck; shot given on 15NOv; still c/o stiff neck on 21NOv; states pt was in bed over weekend w/nausea & general malaise;										11/15/1994	11/17/1994	2		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Malaise; Nausea; Nuchal rigidity	FLU3~CONNAUGHT LABORATORIES~4F51071~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069019	11/28/1994	WY	39.0	39		F	11/21/1994	felt like throat was closing, tightness in chest, wheezing, eyes really dry & puffy; developed flu sx about 7 or 8P; diarrhea & fever, h/a, general malaise;									Y	11/08/1994	11/08/1994	0		PUB	PUB		NONE	allergic to grasses, chocolate, codeine;	~ ()~~~In patient		1						1	Asthma; Chest pain; Diarrhoea; Dry eye; Face oedema; Influenza; Laryngospasm; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51071~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069020	11/28/1994	IA	55.0	55		F	11/22/1994	bleeding from inject site initially but otherwise not problems noted until p/1st 24 hrs then devel lumping-swelling @ site; no pain; no temp; skin eruptions-maculopapular/vesicular some tenderness @ site; w/scabbing @ site;										10/27/1994	10/29/1994	2	NONE	PUB	PVT	SYnthroid, Premarin, Provera;	NONE	MVP, molds, trees etc	~ ()~~~In patient		1						1	Dermatitis bullous; Injection site haemorrhage; Injection site mass; Injection site oedema; Injection site pain; Rash maculo-papular	FLU3~PARKE-DAVIS~00774P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0069022	11/28/1994	IL	68.0	68		F	11/01/1994	URI, chills, aches;									Y	10/04/1994	10/14/1994	10		PVT	PVT	Mollopress	NONE	NONE	~ ()~~~In patient		1						1	Chills; Myalgia; Pharyngitis	FLU3~PFIZER\WYETH~4948033~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0069029	11/28/1994	IL	5.0	5		M		4 hrs p/vax given pt started w/h/a, fever 100 & vomiting; vomiting lasted 2 hrs (6-7times) fever persisted to 102.5 & finally seen by MD 2 days p/vax; dx w/OM									Y	11/16/1994	11/16/1994	0		PVT	PVT		48 hrs p/fax dx Bilat;	NONE	pt exp react 17OCT94 @ 5 yrs w/flu vax #1 dose;~ ()~~~In patient		1						1	Headache; Otitis media; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51069~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069030	11/28/1994	NY	68.0			F	11/18/1994	shaking chills for about 1 hr (10-11PM); 1240AM on 18NOV t102.9; took 1 extra strength APAP; 225AM temp 101.5, 415AM 99.4; pt awoke w/swelling lt lower leg, tenderness inner calf (takes lasix); calling MD today re leg;									Y	11/17/1994	11/17/1994	0	NONE	PUB	OTH	Lasix	NONE	arthritis, fluid retention	NONE~ ()~~~In patient		1						1	Chills; Oedema peripheral; Pain; Pyrexia; Tremor	FLU3~CONNAUGHT LABORATORIES~~3~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069035	11/28/1994	PA	50.0	50		F	11/18/1994	hot flash-sweating-extreme h/a-lining of brain; overall tremors-anxiety-running nose, intestinal cramping; shot in rt arm-inflamed-rash/weakness in rt arm; vision-eyes affected; sensitivity to light & loud noises;										11/02/1994	11/02/1994	0		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Abdominal pain; Anxiety; Headache; Myasthenic syndrome; Photosensitivity reaction; Tremor; Vasodilatation; Visual disturbance	FLU3~PARKE-DAVIS~00494P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0069036	11/28/1994	NJ	45.0	45		M	11/21/1994	red raised rash all over body less than 24 hrs p/flu shot not itchy remains on Antihistamine;									N	11/14/1994	11/15/1994	1	seen by dermatologist today who did blood test	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~4F51129~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068943	11/29/1994	PA	46.0			F	11/07/1994	pt recvd vax & devel total hearing loss; being worked up by an infectious disease specialist & an otorhinolaryngologist;				Y				Y	N					OTH	OTH	none			~ ()~~~In patient	894315001L	1						2	Deafness; Tinnitus; Deafness; Tinnitus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Disabling	Influenza
0069037	11/29/1994	MI	61.0	61		F	11/23/1994	pt recvd vax 18oct94; exp v & fever; on 20oct94, was noted to have fever of 104 & has projectile v; to hosp for v; recovered but episode has worsened stomach problems; hx of unk stomach problem; pt had no problem w/ vax previous yr;					Y	6				10/18/1994	10/20/1994	2	not provided;	OTH	OTH	unk;	none;	unk stomach problems;	~ ()~~~In patient	33201	1						1	Condition aggravated; Diarrhoea; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~00974P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0069038	11/29/1994	NC	70.0			F	11/23/1994	pt recvd vax, exp pneumonia, flu-like sxs & urinary tract infect; on 26oct94, presented w/ chills, fever, body aches & feeling weak; looked very pale;94;while hosp,devel pneumonia & MD felt derived from a staphylococcus infect;					Y				N	10/19/1994	10/26/1994	7	not provided;	PVT	OTH	theo-dur;	none;	emphysema;	~ ()~~~In patient	33202	1						1	Abscess; Dyspnoea; Infection; Influenza; Pleural effusion; Pneumonia; Pyrexia; Urinary tract infection	FLU3~PARKE-DAVIS~00484~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0069049	11/29/1994	MD	23.0	23		F	11/02/1994	pt recvd vax; subsequently adm to hosp w/ renal failure;			Y		Y	14		Y	U	10/19/1994	10/20/1994	1	Renal biopsy: anti-glomerular basement membrane antibodies > 900; serum creatinine 2.1, 2.6, 3.4, 7.4 (dialysis started), 11.0; ASO titer 170; throat cx: nl flora;	PVT	PVT				~ ()~~~In patient	894312004K	1						1	Anuria; Blood creatinine increased; Glomerulonephritis; Haematuria; Immune system disorder; Laboratory test abnormal; Pyrexia; Serum sickness	FLU3~PFIZER\WYETH~4948125~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0069060	11/29/1994	LA	32.0	32		F	11/23/1994	pt recvd vax; localized rxn at inject site; red, hot, swollen 3x6cm then rash began on face, spread to neck, arms & legs;				Y					Y	11/02/1994	11/04/1994	2	none;	MIL	MIL	none;	none;	none;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4948197~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0069061	11/29/1994	MA	78.0	78		M	11/25/1994	pt recvd vax; suspecting re-occurance of stroke; had brain scan, BP, blood analysis all neg; released w/ hismanal; no help; ear examined; no infect; no fluid;									N	11/16/1994	11/17/1994	1	brain scan, blood pressure, blood analysis all neg;	PUB	OTH	pro-cardia; coumadin;	vertigo;	allergy to pcn; had stoke in 1991;	none;~ ()~~~In patient		1						1	Cerebrovascular accident; Condition aggravated	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069062	11/29/1994	VA	68.0	68		U	11/21/1994	pt recvd vax; skin eruption on rt arm; achy joints, h/a, fatigue; stomach pain;skin eruption on lt upper quadrant of abdo;denies fever;sxs occured w/in 12-15 hrs after vax & subsided after 24 hrs of onset;										10/25/1994	10/27/1994	2		UNK	UNK				~ ()~~~In patient		1						1	Abdominal pain; Arthralgia; Asthenia; Headache; Myalgia; Rash	FLU3~CONNAUGHT LABORATORIES~4F51141~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069063	11/29/1994	VA				U	11/13/1994	pt recvd vax on 10oct94; w/in 12 hrs arm became edematous & deep purple in color from inject site to below the elbow; lasted approx 1 wk accompanied by myalgia of arm;										10/10/1994				UNK	UNK			mult allergies;	~ ()~~~In patient		1						1	Myalgia; Oedema peripheral; Skin discolouration	FLU3~CONNAUGHT LABORATORIES~4F51006~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069066	11/30/1994	SC	44.0	44		M	11/01/1994	pt states broke out w/whelps under his rt arm & across his rt side of chest about 930-10 on 31OCT94; states rash followed whelps-states on 1NOV94 woke up rash was gone from chest but had rash on lt hand;									Y	10/31/1994	10/31/1994	0	NONE	PUB	PUB	NONE	NONE	AML, Hepatitis C/allergies PCN, cornbread	~ ()~~~In patient	SC94104	1						1	Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~4948215~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069067	11/30/1994	SC	37.0	37		F	11/10/1994	pt recvd flu vax 930AM; face became fiery red 24 hrs later;									Y	11/05/1994	11/06/1994	1	NONE	PUB	PVT	NONE	NONE	NONE	NA~ ()~~~In patient	SC94108	1						1	Vasodilatation	FLU3~PFIZER\WYETH~4948130~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0069070	11/30/1994	OH	11.0	11		F	11/26/1994	pt recvd vax 25NOV94 & on 26NOV94 MD onc call saw pt w/sx of both arms & chest hurt, chills, fever 100.2-102, h/a, since receiving vax;				Y						11/25/1994	11/25/1994	0		PVT	UNK	TB Tine			~ ()~~~In patient		1						1	Chest pain; Chills; Headache; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0069071	11/30/1994	LA	71.0	71		M	11/23/1994	pt recvd vax 3NOV94,5NOV94 sl throat irritation;6NOV94 react worse felt like flu, bones hurt, high fever & finally almost comatose-didn't know what day, or what time it was x 3 days; lung congestion, chills, burning up,lasted 1 wk;										11/03/1994	11/06/1994	3		PUB	UNK		NONE	have elevated blood sugar count, preset 138	NONE~ ()~~~In patient		1						1	Chills; Confusional state; Cough; Headache; Influenza; Lung disorder; Pharyngitis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069072	11/30/1994	VA	56.0	56		M	11/15/1994	30-36 hrs p/flu shot pt had sx that mimicked & strengthen (enhanced) nerve tingling sensations in feet & hands; swallowing was also very difficulty; these sx disappeared on Wednesday 2NOV;									Y	10/31/1994	11/01/1994	1	NONE	OTH	PUB	Norm A Dyne, Atavan	chronic GBS	GBS	~ ()~~~In patient		1						1	Condition aggravated; Dysphagia; Paraesthesia	FLU3~PFIZER\WYETH~4948197~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0069075	11/30/1994	AR	34.0	34		M	11/22/1994	onset day 3-4 myalgias, weakness;migratory (proximal to distal flexors to extensors); dx polymyositis-lab CPK 800's; days 10-11 facial rashes; tx steroids day 13; time course 3 wks;									U	11/03/1994	11/06/1994	3	lab CPK 800's; infectious etiologies r/o via serum titers ESR nl range;	PVT	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Asthenia; Blood creatine phosphokinase increased; Myalgia; Myositis; Rash	FLU3~PFIZER\WYETH~4948142~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0069077	11/30/1994	MN	59.0	59		F	11/28/1994	6-8 wks painful, swollen arm w/ecchymosis for 8 wks-believes also had low grade fever-however undocumented;									Y	10/01/1994	10/07/1994	6		PVT	PVT	Provecal; Cardizem;	NONE	in chol, GERD, TMJ, obesity, impaired glucose tolerance	NA~ ()~~~In patient		1						1	Ecchymosis; Oedema peripheral; Pain; Pyrexia	FLU3~PARKE-DAVIS~00774P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0069163	11/30/1994	VA				U		pt recvd vax 25OCT94 & devel fever of 103, rash on arms & legs, ached all over rash, ache started 48 hrs p/inject; fever 72 hrs p/inject; given Pred 10NOV94 for tx; cont w/fever & noc sweats;										10/25/1994				UNK	UNK				~ ()~~~In patient		1						1	Hyperhidrosis; Myalgia; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~4F51141~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069150	12/01/1994	TX				U	11/10/1994	pt recvd flu vax & pt devel pancytopenia according to a local hematologist-oncologist physician;					Y				U					OTH	OTH	unk	unk		~ ()~~~In patient	894319014K	1						1	Pancytopenia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0069157	12/01/1994	WI	38.0	37		F	11/18/1994	warm, red, itchy sensation @ site of inject 24 hrs p/inject; Cortaid/DPH recommended;									Y	11/11/1994	11/12/1994	1	NA	PVT	PVT	Azmacort inhaler; Ventolin inhaler	resolved Bronchitis	asthma, allergic rhinitis	~ ()~~~In patient	WI94107	1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51022~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069159	12/01/1994	NC	85.0	85		F	11/23/1994	pt recvd vax 31OCT94 1030AM & 1PM devel cold, clammy skin w/t97.2 ax; 2PM t103.3 R; 250PM T102.6R; Epi given-to ER dx febrile illness-poss viral synd, hypernatremia/chloremia, d/c ed on 1NOV; died 9NOV94;	Y	11/09/1994		Y	Y	1			N	10/31/1994	10/31/1994	0		OTH	PUB	Lanoxin, Calan, nitropatch; Haldol; Zantac	NONE	hx of CVA, organic brain synd, UTI, hypertension, UGI bleed, CAD, allergies Tetrapline, PCN, Prunes, coffee, cream, jello	pt exp flu-like s/s @ 77yrs w/flu #1~ ()~~~In patient		1						1	Hypernatraemia; Hyperventilation; Hypotension; Hypothermia; Infection; Pneumonia; Pyrexia; Tachycardia	FLU3~CONNAUGHT LABORATORIES~4F51129~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0069162	12/01/1994	MA	59.0	58		M	11/14/1994	dizziness/lightheadedness-started w/in 24 hrs of inject;				Y					Y	10/14/1994	10/15/1994	1	MRI-nl; EKG-nl; BLood pressures nl; CXR nl; Blood test nl;	MIL	UNK	Insulin, Xantac, Lopid	NONE	NONE/AODM/diabetic retinopathy hyperlipidemia	~ ()~~~In patient		1						1	Dizziness	FLU3~PFIZER\WYETH~4948122~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0069174	12/02/1994	AR	57.0	57		F		pt recvd vax approx 8:35am;8:45 c/o h/a & dizziness;assisted to exam table;feet up cold cloth applied;8:50 BP 180/100 P 60;color pale;resp quiet & regular;8:55 BP 170/80;given orange juice;color better; dec dizziness & h/a; Pt better;									Y	10/22/1994	10/22/1994	0		PUB	OTH	na;	denied by pt;	iddm 15u reg, 35NPH w/ orinase, inc BP vasotech, minipress; diazide;	none;~ ()~~~In patient	AR9497	1						1	Condition aggravated; Dizziness; Headache; Hypertension; Pallor	FLU3~CONNAUGHT LABORATORIES~4F51024~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069177	12/02/1994	MO	56.0	56		F	11/17/1994	pt recvd vax on 1nov94;no sxs noted;felt feverish for rest of wk;6nov94 felt real bad;while on phone 7nov94 at 6:30pm passed out;to er; p/CT scan & EEG still unconscious;to hosp from 8nov94 to 11nov94;tentative dx viral meningitis;				Y	Y	5			Y	11/01/1994	11/06/1994	5	eeg & blood work; MRI; CT scan & spinal tap;	PUB	PUB	none;	sinus h/a;	atb; aluminum, anaphylactic; tetracyclines, septomycin, terramycin, keflex;	in pt, had rxn in 1993 w/ flu vax;~ ()~~~In patient	MO94101	1						1	Coma; Infection; Meningitis; Pyrexia; Syncope	FLU3~CONNAUGHT LABORATORIES~4F5116~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0069181	12/02/1994	OH	42.0	42		M	11/18/1994	pt recvd vax;14nov94 am pt started w/ joint aches(knees & elbows);14nov & 15nov aching cont; 16nov t of 101; 17nov 7am t 98 & 4pm t 102 & aching subsided; 18nov 7am t 98; taking apap & aspirin alternating q 4 hrs;									U	11/12/1994	11/14/1994	2	none;	PUB	PVT	none;	none;	none;	none;~ ()~~~In patient	OH94120	1						1	Arthralgia; Myalgia; Pyrexia	FLU3~PARKE-DAVIS~00274~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0069183	12/02/1994	FL	79.0	79		M	11/15/1994	pt came to ofc for lab work;wife requested he have flu vax;given in am, approx 15 min after leaving,wife called from hosp er,stated after getting into car pt Lt arm began twitching & head fell over to side;	Y	11/14/1994		Y					N	11/14/1994	11/14/1994	0		PVT	PVT	capoten, ativan, nitrodur patch, micro K; reg ASA; bumex; nitrostat;	none;	calan sr, severe cardiomyopathy;	~ ()~~~In patient		1						1	Muscle twitching	FLU3~PARKE-DAVIS~00774P~3~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0069184	12/02/1994	WA	38.0			F		pt recvd vax;exp shaking chills; violent retching, fever 105; sudden onset 2 hrs after vax; no other evidence of illness;					Y		Y			10/21/1994	10/21/1994	0	blood culture no growth;	UNK	UNK			allergies: sulfa; meds (routine), premarin;	~ ()~~~In patient		1						1	Chills; Pyrexia; Tremor; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51158~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0069188	12/02/1994	WY	26.0	25		F	11/23/1994	pt recvd vax; 4 hrs later devel swollen eyes,mattered & red eyes; chest congestion, cough; swollen glands, ear ache; 24 hrs later devel diarrhea; resolved in 48 hrs;									Y	11/21/1994	11/21/1994	0		PUB	PUB	none;	none;	none;	none;~ ()~~~In patient		1						1	Conjunctivitis; Cough; Diarrhoea; Ear pain; Face oedema; Lung disorder; Lymphadenopathy	FLU3~CONNAUGHT LABORATORIES~4F51071~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069190	12/02/1994	NY	28.0	28		M	11/28/1994	pt recvd vax; on 17nov94 pt called & c/o swelling & discomfort in Lt arm; had swelling & inflammation of upper & lower Lt arm; resolved w/ NSAID in 48 hrs;									Y	11/16/1994	11/17/1994	1	na;	PVT	PVT	none;	none;	none;	na;~ ()~~~In patient		1						1	Injection site inflammation; Injection site oedema; Oedema peripheral; Pain	FLU3~PFIZER\WYETH~4948114~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~380957~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0069215	12/05/1994	MI	47.0	47		F	11/14/1994	pt recvd vax on 8nov94; next day exp flu-like sxs for wihich she recvd tx;on 13nov94 was adm to hosp w/ red, bumpy rash & viral asthmatic bronchitis:; work up is pending;			Y	Y	Y	30	Y		U	11/07/1994	11/08/1994	1	23nov94 blood glucose  nl range 70-110 mg%; pt's value 235;	PVT	PVT	unk;	asthma;	long hx of asthma; had pneumonia approx 2 weeks prior to this adverse event; smoked one pack cigarettes a day for 30 years; obese;	~ ()~~~In patient	894319013K	1						1	Bronchitis; Condition aggravated; Dermatitis bullous; Dyspnoea; Epidermal necrosis; Infection; Pneumonia; Respiratory disorder	FLU3~PFIZER\WYETH~4948045~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0069220	12/05/1994	GA	67.0	67		M	11/16/1994	pt recvd vax 3nov94; on 6nov started having problems w/ asthma;on 7nov had to inc prednisone to control asthma flair up; pt felt flu vax caused his asthma to worsen;MD appointment 22nov;									Y	11/03/1994	11/06/1994	3	none;	PUB	PUB	prednizone; xanax; proventil; advent; zantac;		COPD chronic bronchial asthma, adrenal insuff;	~ ()~~~In patient	GA94156	1						1	Condition aggravated	FLU3~PFIZER\WYETH~4948124~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0069221	12/05/1994	GA	47.0	47		F	11/16/1994	pt recvd vax; inject site Rt arm red;swollen; warm w/ a red line going to medial rt upper arm which is red,warm & swollen; moderate ache in rt arm shoulder; apap helpful;									Y	11/14/1994	11/16/1994	2		PUB	PUB				~ ()~~~In patient	GA94157	1						1	Injection site hypersensitivity; Injection site oedema; Myalgia; Skin striae; Vasodilatation	FLU3~PARKE-DAVIS~00873P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~324906~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0069230	12/05/1994	ID	42.0	42		F	10/27/1994	pt recvd vax; tired, h/a for 2 days; by 4th day spiked t, ached all over; by 5th day, t still 101 & entire body ached; felt washed out;									Y	10/19/1994	10/20/1994	1	none;	OTH	PUB		none;	none;	none;~ ()~~~In patient	ID94063	1						1	Asthenia; Headache; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4948049~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0069231	12/05/1994	ID	64.0	64		F	10/20/1994	pt recvd vax; itching began 3 hrs after inject; cont to inc  w/ red, sl raised rash covering trunk in 48 hrs;saw PMD; getting better; by 22nov some fading & 26nov all gone;				Y					Y	10/13/1994	10/13/1994	0	none;	PUB	PUB	toprol, procardia, zocar;	none;	coronary artery disease;	~ ()~~~In patient	ID94064	1						1	Pruritus; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~4F51055~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069232	12/05/1994	ID	61.0	61		M	11/02/1994	pt recvd vax;onset of ascending progressive weakness beginning am 26oct94;to er & dx w/ GBS; now on ventilator,getting plasmapharesis;			Y	Y			Y		N	10/11/1994	10/26/1994	15	csf: RBC0, WBC0, glucose 72, protein 59 [20-40], cx neg;	PUB	OTH	none;	none;	copd;	none;~ ()~~~In patient	ID94065	1						1	Asthenia; CSF test abnormal; Guillain-Barre syndrome; Respiratory disorder	FLU3~PFIZER\WYETH~4948106~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0069234	12/05/1994	ID	43.0	43		F	11/02/1994	pt recvd vax; next day arm swollen; 2nd day swelling spread to axilla & breast,fingers tingling arm throbbing, painfull to touch axilla area;				Y					U	10/31/1994	11/01/1994	1		PUB	UNK	none;	none;	drug allergies: codeine, morphine;	~ ()~~~In patient	ID94067	1						1	Ear disorder; Infection; Myalgia; Oedema peripheral; Pain; Paraesthesia; Pericarditis; Pneumonia	FLU3~CONNAUGHT LABORATORIES~4F51165~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069235	12/05/1994	ID	33.0	33		M	10/31/1994	pt recvd vax;2 hrs after vax began to feel very tired & weak;skin turned white while got up to use bathroom & fainted; was shaky & cold afterwards;cont to feel weak & tired for 24 hrs;									Y	10/21/1994	10/21/1994	0		PUB	PVT		none;	none;	~ ()~~~In patient	ID94068	1						1	Asthenia; Chills; Pallor; Syncope; Tremor	FLU3~CONNAUGHT LABORATORIES~4F51024~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069236	12/05/1994	ID	38.0	38		F	11/04/1994	pt recvd vax;pt c/o sweatin; weakness;shaking during 10 min;BP range 140/100-130/90 over next 40 min;no chest tightness; no syncope or hives;pt told to rest under observation for 50 min; sent home;MD recommended DPH;however was never taken;									Y	11/01/1994	11/01/1994	0		PUB	PUB	none;	none;	none;	none;~ ()~~~In patient	ID94069	1						1	Asthenia; Hyperhidrosis; Hypertension; Tremor	FLU3~CONNAUGHT LABORATORIES~4F51024~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069237	12/05/1994	ID	38.0	38		M	10/25/1994	pt recvd vax; w/in 2 hrs of vax had tightness in chest; cough, blood shot eyes, puffy eyelids; body aches & fever; felt bad for about 7 days;									Y	10/24/1994	10/24/1994	0		PUB	PUB	none;	none;	none;	~ ()~~~In patient	ID94070	1						1	Chest pain; Conjunctivitis; Cough; Face oedema; Malaise; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51067~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069239	12/05/1994	ID	48.0	48		F	11/16/1994	pt recvd vax;about 8 hrs later had generalized aching which lasted 24 hrs;had pains & weakness in arm & hand;after 4 1/2 wks still aching;sometimes pains & general weakness of arm & hands; has had flu vax previously w/ no problems;								Y	N	10/17/1994	10/17/1994	0	none;	PUB	PUB	none;	none;	none;	none~ ()~~~In patient	ID94072	1						1	Myalgia; Myasthenic syndrome; Pain	FLU3~CONNAUGHT LABORATORIES~4F51165~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0069240	12/05/1994	ID	28.0	27		F	11/08/1994	pt recvd vax;3 hrs p/inject coughing,chest pain,swelling of neck glands;SOB; diff swallowing & talking;given epi & steroid;during noc felt like burning up & sweating;no inc t;8nov very tired & sweating;took antihist				Y					Y	11/07/1994	11/07/1994	0		PUB	PUB	naprosyn; amoxicillin; ampicillin;	cold; no fever;		~ ()~~~In patient	ID94073	1						1	Asthenia; Chest pain; Cough; Dysphagia; Dyspnoea; Lymphadenopathy; Pyrexia; Speech disorder	FLU3~CONNAUGHT LABORATORIES~4F51072~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069242	12/05/1994	ID	53.0	53		F	11/21/1994	pt recvd vax; eye lids swollen; eyes red/blodshot; face swollen; eyes burned;									Y	11/09/1994	11/09/1994	0		PUB	PUB	premarin;	na;		~ ()~~~In patient	ID94075	1						1	Conjunctivitis; Eye pain; Face oedema	FLU3~CONNAUGHT LABORATORIES~4F51072~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069243	12/05/1994	MA	58.0	58		F	11/29/1994	pt recvd vax; onset od chills, fever, malaise at approx 1 wk after vax; also exp upper resp congestion; duration approx 1 1/2 wks; sxs resolved by 21nov94;									Y	11/09/1994	11/16/1994	7		PUB	PUB				unk;~ ()~~~In patient	MA9435	1						1	Chills; Malaise; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~4F51025~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069244	12/05/1994	MA	38.0	37		F	11/29/1994	pt recvd vax; redness swelling both hands; tingling of tongue; redness, itching swelling of feet blister on toe & heel;				Y					Y	11/21/1994	11/21/1994	0	none;	OTH	UNK	vits;	none;	none;	in pt, exp dizziness & flu sx in sep92 w/ 1 dose of hep;~ ()~~~In patient	MA9436	1						1	Dermatitis bullous; Oedema peripheral; Paraesthesia oral; Pruritus; Vasodilatation; Oedema peripheral; Pruritus	FLU3~CONNAUGHT LABORATORIES~4F51025~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0069245	12/05/1994	KS	34.0	34		F	11/30/1994	pt recvd vax; mid line at lt side of head all the way to shoulder; soreness, stiffness & nerves sensitive; 30nov94 starting to feel better;									Y	11/21/1994	11/23/1994	2		PVT	PVT				~ ()~~~In patient	MO94104	1						1	Headache; Hypertonia; Myalgia; Neck pain; Nuchal rigidity	FLU3~PARKE-DAVIS~4948108~1~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0069246	12/05/1994	MO	48.0	47		F	11/23/1994	pt recvd vax;pt stated rt arm was swollen at least twice nl size (deltoid area) & was red & hot for 3-4 days; inject site remained a blister for 2 wks later & 1 mo later, there still remains a scab;									Y	10/26/1994	10/26/1994	0		PUB	UNK			states allergic to pcn only;	~ ()~~~In patient	MO94105	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51113~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069249	12/05/1994	NC	56.0	56		F	11/16/1994	pt recvd vax 10nov94; 13nov94 some numbness in hands; 14nov94 feet, legs, hands swollen; ringing in ears; 16nov94 face swollen;				Y					N	11/10/1994	11/13/1994	3	cbc - urinalysis;	PUB	PUB	none;	none;	allergy to bee stings;	none;~ ()~~~In patient	NC94133	1						1	Face oedema; Oedema peripheral; Paraesthesia; Tinnitus	FLU3~PFIZER\WYETH~4948111~7+~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0069254	12/05/1994	OH	80.0	80		F	11/09/1994	pt recvd vax; exp at 5pm 3nov94 n & v; diaphoresis, diarrhea until 6nov94 at 12 noon;									Y	11/03/1994	11/03/1994	0		PUB	PUB	dyazide;	none;	allergy to perfume; hypertension;	in pt, n & v w/ flu vax at 74-75 yrs of age;~ ()~~~In patient	OH94117	1						1	Diarrhoea; Hyperhidrosis; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51016~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069255	12/05/1994	OH	61.0	60		F	11/18/1994	pt recvd vax;throat tickle, cough began 1 hr after vax then eyes itched, swelling of eyes,chest felt like elephant was sitting on it;to hosp;seen by MD;adm to hosp, IV-O2 monitored all noc;next day sent home on dose pack pred;				Y	Y	1			Y	11/02/1994	11/02/1994	0		PUB	PUB	cardizem; DPH; Premarin, Provera		heart condition; allergies; nose & hands itch;	~ ()~~~In patient	OH94118	1						1	Chest pain; Cough; Face oedema; Pruritus	FLU3~CONNAUGHT LABORATORIES~4F51055~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0069256	12/05/1994	OH	81.0	81		F	11/22/1994	pt recvd vax;next day,tightened up;wound up like a toy & locked in,arms & legs stiff & could hardly get them to move;if bent over , would hurt cause so tight,a deep hurting;also chilled & ached all over, some h/a;lasted 2 1/2 days;took meds				Y					N	10/07/1994	10/08/1994	1	none;	PUB	PUB	synthroid;	none;	polymyalgia rheumatica in 1980 at clinic;	none;~ ()~~~In patient	OH94123	1						1	Chills; Headache; Hypertonia; Hypokinesia; Myalgia; Pain	FLU3~PFIZER\WYETH~4948126~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0069257	12/05/1994	OH	41.0	41		F	11/21/1994	pt recvd vax & approx 3 hrs later exp, itchy,watery eyes; a cough w/ chest congestion & wheezing, & difficulty breathing;felt chilled but did not take t; sxs lasted approx 4 hrs; pt did not seek medical tx; took DPH;									Y	11/16/1994	11/16/1994	0	none;	PUB	PUB	none;	none;	allergy PCN	~ ()~~~In patient	OH94124	1						1	Asthma; Chills; Cough; Dyspnoea; Lacrimal disorder; Lung disorder; Pruritus	FLU3~CONNAUGHT LABORATORIES~4F51070~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069262	12/05/1994	MD	49.0	49		F	11/30/1994	pt recvd vax; post vax encephalitis; persistent fever (reached 103.6 9oct94) ; h/a, n, & achy joints; still has trouble concentrating;				Y	Y	3			U	09/23/1994	09/25/1994	2	ct scan, xrays, no lp;	UNK	UNK	estrace;	none;	none;	none;~ ()~~~In patient	WV9432	1						1	Arthralgia; Encephalitis; Headache; Pyrexia; Thinking abnormal; Encephalitis; Headache; Pyrexia	FLU3~PFIZER\WYETH~4948125~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4948125~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0069263	12/05/1994	PA				F	11/28/1994	pt recvd vax; next am reported had an allergic rxn, swollen eyes & difficulty breathing; tx by MD w/ DPH & proventil MDI;			Y	Y					Y	10/06/1994	10/06/1994	0		PVT	PVT				~ ()~~~In patient		1						1	Dyspnoea; Face oedema; Hypersensitivity	FLU3~PFIZER\WYETH~4948075~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening	Influenza
0069264	12/05/1994	PA	67.0	67		F	11/28/1994	pt recvd vax;adm to hosp for acute myopathy;neurologist felt mult sclerosis or post vax spinal synd;discharged 4nov;;f/u recent spinal cord synd w/ lt lower extremity weakness;now ability to walk w/ a cane;			Y		Y	10			Y	10/03/1994	10/25/1994	22		PVT	PVT			dm, hypercholesterolemia;	~ ()~~~In patient		1						1	Gait disturbance; Multiple sclerosis; Myasthenic syndrome; Myopathy	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0069268	12/05/1994	NY	60.0			F	11/28/1994	pt recvd vax;GBS w/ siadh & encephalitis;1 wk ago began tingling sensations in hands;later c/o discomfort w/ achiness,malaise & weakness;very restless that noc;to er;was observed to have some shaking on arm poss rt leg;felt sz;sodium low;			Y	Y	Y	30			Y	10/24/1994	11/01/1994	8	csf protein inc; lp, mri/ct; ? demyelination; na+ 115;	OTH	OTH	none;	none;	none;	~ ()~~~In patient		1						1	Asthenia; Confusional state; Encephalopathy; Eye disorder; Guillain-Barre syndrome; Inappropriate antidiuretic hormone secretion; Neuropathy; Paraesthesia	FLU3~PARKE-DAVIS~01564P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation	Influenza
0069271	12/05/1994	MA	69.0	69		M	11/29/1994	pt recvd vax; swelling of throat & face; to er; DPH injected;				Y					Y	11/10/1994	11/10/1994	0	none;	PUB	PUB	none;	none;	none;	~ ()~~~In patient		1						1	Face oedema; Laryngospasm	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0069273	12/05/1994	CT	62.0	62		M	11/30/1994	pt recvd vax; w/in 24 hrs pt reporting lip swelling & generalized urticaria & mild shortness of breath; tx w/ antihistamines, po/topical steroids;				Y					Y	10/20/1994	10/20/1994	0		PUB	PUB	darvon;	none;	none;	~ ()~~~In patient		1						1	Dyspnoea; Face oedema; Urticaria	FLU3~PARKE-DAVIS~004749~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0069275	12/05/1994	TX	31.0	31		U		pt recvd vax; had red spot on neck, chest, & legs; itching;				Y					Y	11/06/1994	11/06/1994	0	none;	OTH	PVT	none;	none;	none;	none;~ ()~~~In patient		1						1	Pruritus; Rash	FLU3~PFIZER\WYETH~4948113~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0069276	12/05/1994	PA	73.0			F	11/28/1994	pt recvd vax; 2 days later lt arm was swollen; fever; 6oct94 seen in ofc & dx w/ cellulitis;  unk if flu vax or pneumovax;				Y					Y	10/04/1994	10/06/1994	2		PVT	UNK				~ ()~~~In patient		1						1	Cellulitis; Oedema peripheral; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~~UNK~~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0069280	12/05/1994	CA	39.0	39		F	11/28/1994	pt recvd vax; pruritic rash on wrists, face, arms, axillae features similar to contact dermatitis, but pt had similar rxn to prior flu shot; no exposure to poison oak or irritants;				Y					Y	10/04/1994	10/04/1994	0	na;	PVT	PVT	lotensin; synthroid;	none;	none;	in pt, same rxn to flu shot few yrs ago;~ ()~~~In patient		1						1	Pruritus	FLU3~CONNAUGHT LABORATORIES~4F51079~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069294	12/05/1994	NJ	59.0	59		F	11/19/1994	severe head pain-back of head-ear to ear across bottom of hairline; began evening of shot-severe pain-lasting approx 2 wks; ASA taken daily for relief some sl cold sx began @ same time;									Y	11/03/1994	11/03/1994	0		PUB	PUB	NONE	NONE	sulfa-yellow dye #5	pt's father exp severe flu like sx @ 55-60 y/o w/flu shot #1 dose;~ ()~~~In patient		1						1	Headache; Pain; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069297	12/05/1994	MA	53.0	53		F	11/26/1994	sore throat-aching behind eyes- chills-fever-tiredness-missed 2 days of work; aching in legs & hips-sx lasted 1 wk; tiredness lasted several days longer;									Y	10/22/1994	10/28/1994	6		PUB	PVT	Nasocort nasal spray; Estraderm patch	NONE	seasonal-trees weeds-alterneria, PCN, some animals	~ ()~~~In patient		1						1	Arthralgia; Asthenia; Chills; Headache; Myalgia; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4938083~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069298	12/05/1994	MD	72.0	72		F	11/25/1994	17OCT94 sore throat by evening of flu shot; 18OCT94 cold, sniffles, cough, felt feverish but no temp; 19OCCT94 h/a, very tired; 23OCT94 stiff neck, shoulder pain, laryngitis; for about a month felt problems & believe that VitC tablets help									Y	10/17/1994	10/17/1994	0	NONE	PUB	UNK	APAP	NONE	Osteoarthritis	pt exp similar sx but they started 2 days p/flu shot in 1993;~ ()~~~In patient		1						1	Asthenia; Cough; Headache; Laryngitis; Nuchal rigidity; Pain; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069299	12/05/1994	PA				F	11/28/1994	local reaction & secondary adenitis										10/01/1994				UNK	UNK				~ ()~~~In patient		1						1	Injection site reaction; Lymphadenopathy	FLU3~CONNAUGHT LABORATORIES~4F51023~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069300	12/05/1994	PA				F	11/28/1994	4cm local react, erythematous;									Y	10/01/1994				UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~4F51023~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069301	12/05/1994	PA				U	11/28/1994	large local react-paresthesias;										10/01/1994				UNK	UNK			latex allergy: no latex gloves or bandaids used;	~ ()~~~In patient		1						1	Injection site reaction; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069302	12/05/1994	PA				F	11/28/1994	local react-believe dose given SQ;										10/01/1994				UNK	UNK				~ ()~~~In patient		1						1	Injection site reaction	FLU3~CONNAUGHT LABORATORIES~4F51023~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069303	12/05/1994	PA				F		local react, poss due to SQ administration;										10/01/1994				UNK	UNK				~ ()~~~In patient		1						1	Injection site reaction	FLU3~CONNAUGHT LABORATORIES~4F51072~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069304	12/05/1994	PA				F	11/28/1994	cellulitis; pt devel erythemia, edema & temp; pt seen in ER 7NOV94 dx w/cellulitis & tx w/Keflex;				Y						11/04/1994				PVT	PVT				~ ()~~~In patient		1						1	Cellulitis; Oedema; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~4F51012~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069305	12/05/1994	PA				F	11/28/1994	@ site of inject reddened, inflamed & tender 2 days p/inject; 3 days: looks & feels better than day 1 & 2;									Y	11/08/1994	11/10/1994	2		PVT	PVT				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site inflammation; Injection site pain	FLU3~CONNAUGHT LABORATORIES~4F51155~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069306	12/05/1994	PA				M	11/28/1994	generalized pruritic rash (viral sxs);									Y	10/01/1994				PVT	PVT			similar rxn last yr-self treated	~ ()~~~In patient		1						1	Infection; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069307	12/05/1994	PA				M	11/22/1994	h/a, stuffy nose, w/o fever x 3 day post flu shot;									Y	10/01/1994				PVT	PVT	unk	NONE		~ ()~~~In patient		1						1	Headache; Rhinitis	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069308	12/05/1994	PA	82.0			M	11/28/1994	nasal congestion, cough, cold, fever x 7 days; beginning 608 hrs p/shot was given; poss underlying viral type infect; bronchitis-like;									Y	10/31/1994				PVT	PVT			sulfa, PCN, Cipro & Flagyl allergies	~ ()~~~In patient		1						1	Bronchitis; Cough; Infection; Pharyngitis; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069310	12/05/1994	MA	33.0	33		M	11/16/1994	red, swelling in vax area for 3 days; full recovery									Y	11/03/1994	11/03/1994	0	NONE	OTH	UNK	NONE	NONE		~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4948110~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0069312	12/05/1994	PA	37.0	37		F	11/17/1994	the day p/vax pt felt hot & cold & @ the same time was lightheaded & dizzy;									Y	10/17/1994	10/18/1994	1	NONE	OTH	OTH	NONE	NONE	asthma	NONE~ ()~~~In patient		1						1	Chills; Dizziness; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51129~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069315	12/05/1994	CA	51.0	51		F	11/22/1994	temp to 100.0, chills, wheezing on inspiration (mild) jittery feeling, fatigue, dry eyes, swelling, myalgias lasted for 1-2 days;									Y	11/10/1994	11/10/1994	0	NONE	PVT	PVT	Levoxine, Premarin, Provera, Motrin	NONE	hypothyroidism, rt parotid tumor resection 1990;	~ ()~~~In patient		1						1	Asthenia; Chills; Dry eye; Myalgia; Nervousness; Oedema; Pyrexia; Stridor	FLU3~CONNAUGHT LABORATORIES~4F51072~UNK~IM L~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069320	12/05/1994	OH	53.0	53		M	11/25/1994	congestion, fever, cough; nasal & chest congestion-lasting 2-3 wks-tx w/fluids-ATB;									Y	10/11/1994	10/13/1994	2	NONE	OTH	PVT	Clonididine; Persantine, Hydralazine, Inderal, Vitamins;	NONE	hypertension	~ ()~~~In patient		1						1	Cough; Lung disorder; Pyrexia; Rhinitis	FLU3~PFIZER\WYETH~4948053~7+~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0069326	12/05/1994	NY	63.0	63		F	11/15/1994	18OCT-3PM severe abdo cramps lasting overnoc; digestive system not affected; lost 1 day of work; Thursday PM asthma flare-up; had to use inhalator; Friday PM broke out in hives around waist line;									Y	10/18/1994	10/19/1994	1		UNK	UNK			asthma	~ ()~~~In patient		1						1	Abdominal pain; Condition aggravated; Urticaria	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069333	12/05/1994	AL	28.0	28		M	11/30/1994	macular erythema on hands (dorsal & palmar) feet (dorsal) w/minimal out break on arms legs; rash is pruritic; also c/o h/a; doubt this is related to vax since no react @ inject site & took codeine day of vax;										11/28/1994	11/29/1994	1		PVT	PVT	APAP #3	NONE		~ ()~~~In patient		1						1	Headache; Pruritus; Rash maculo-papular	FLU3~PFIZER\WYETH~4948057~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0069334	12/05/1994	FL	85.0	85		M	11/27/1994	10NOV94 6PM started sneezing about 200 times that evening; next day had sore throat, h/a, felt awful; nose had a steady drizzle of water had to plug nose so could eat; had bad cough-very bad case of flu; pt still exp hang over from flu;										11/10/1994	11/10/1994	0		UNK	UNK				~ ()~~~In patient		1						1	Cough; Headache; Influenza; Malaise; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069336	12/05/1994	FL	23.0	23		F	11/21/1994	rash on lt arm (lower 1/2 of arm), inside of knees (both) & near ankles (inside portion); felt some nausea last PM also but no vomiting; no fever or nausea @ this time;									Y	11/19/1994	11/20/1994	1	NA	OTH	UNK	NONE	NONE	psoriasis/eczema (palms of hands, bottom feet)	NA~ ()~~~In patient		1						1	Nausea; Rash	FLU3~CONNAUGHT LABORATORIES~4F51071~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069338	12/05/1994					U		inject site red, hot & swollen;											10/18/1994			UNK	UNK			NKDA	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~4948051~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069339	12/05/1994					U	10/27/1994	site of inject, red, swollen & hot;											10/25/1994			UNK	UNK			NKDA	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~4948051~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069340	12/05/1994					U		site of inject red, swollen & hot;											10/25/1994			UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~4948051~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069341	12/05/1994					U		site of inject sore & swollen & stiff, also had chills;											10/11/1994			UNK	UNK				~ ()~~~In patient		1						1	Chills; Injection site oedema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~4948051~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069342	12/05/1994					U		site of inject red & swollen;											10/11/1994			UNK	UNK			N.K.D.A.	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLUX~UNKNOWN MANUFACTURER~4948051~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069343	12/05/1994					U		site of inject red & swollen;											10/04/1994			UNK	UNK			N.K.D.A.	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLUX~UNKNOWN MANUFACTURER~4948051~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069344	12/05/1994					U		soreness & swelling @ site of inject also flu like sx;											10/10/1994			UNK	UNK			allergies dust-pollen	~ ()~~~In patient		1						1	Influenza; Injection site oedema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~4948051~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069345	12/05/1994					U		sore throat, h/a & aching all over;											10/11/1994			UNK	UNK			hayfever, mold	~ ()~~~In patient		1						1	Headache; Myalgia; Pharyngitis	FLUX~UNKNOWN MANUFACTURER~4948051~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069346	12/05/1994					U		arm sore, achey all over, tired, fever, nausea & diarrhea;											10/11/1994			UNK	UNK			N.K.D.A.	~ ()~~~In patient		1						1	Asthenia; Diarrhoea; Myalgia; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~4948051~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069347	12/05/1994					U		arm red & swollen & hot @ site of inject;											10/11/1994			UNK	UNK			N.K.D.A.	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~4948051~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069356	12/06/1994	IN	61.0	61		M	11/30/1994	pt recvd vax; severe h/a 5-10 mins after vax;25-30 mins later,went home took nap;slept for 2 1/2 hrs; h/a gone when awoke;no oth rxns;									Y	11/09/1994	11/09/1994	0	none;	PUB	PUB	capoten; procardia; Slo-Bid	none;	pcn, emphysema, hypertension, CVHD;	~ ()~~~In patient		1						1	Headache	FLU3~CONNAUGHT LABORATORIES~4F51165~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069357	12/06/1994	WY	13.0	13		F	11/09/1994	pt recvd vax;cough,difficulty breathing in, lungs sounds dec;BP 130/100;P 80, R 24;md notified & pt having asthma;meds given; BP 110/70,P 80's;R 20's;lung sounds clear; pt tired; local rxn to adrenalin site with vaso constriction;									Y	11/09/1994	11/09/1994	0		PUB	PUB	ventalin inhaler;	none;	asthma;	~ ()~~~In patient		1						1	Asthenia; Condition aggravated; Cough; Dyspnoea; Hypertension	FLU3~CONNAUGHT LABORATORIES~4F51072~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069358	12/06/1994	WY	16.0	15		M	11/08/1994	pt recvd vax 11:30; at 12:55, to mom & c/o diaphoresis, tremors;h/a & n;1:02 mom came to rn;pt was diaphoretic,cold,clammy, tremerous hands,feet & head; n;dizziness;BP 182/90;AP 110 w/ c/o dyspnea;meds given;sxs resolved;									Y	11/08/1994	11/08/1994	0	na;	PUB	PUB	none;	none;	none;	none;~ ()~~~In patient		1						1	Dizziness; Dyspnoea; Headache; Hyperhidrosis; Hypertension; Hyperventilation; Tachycardia; Tremor	FLU3~CONNAUGHT LABORATORIES~4F51072~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069361	12/06/1994	DC	75.0	75		F	12/02/1994	pt recvd vax;high fever;too disoriented to measure;unable to control motion;fell into bed;unable to use phone; staggered to bathroom; cont incompetent through night; about 9am mostly recovered on 9NOV									Y	11/08/1994	11/08/1994	0		MIL	UNK	none;	none;	chronic lymphocytic leukemia;	none;~ ()~~~In patient		1						1	Confusional state; Gait disturbance; Movement disorder; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069367	12/06/1994	KS	17.0	17		F	11/29/1994	pt recvd vax;stat c/o feeling dizzy;moved  arm & acted as though might faint; mom & rn had lay pt on floor w/ cold, damp towel on face;when began to feel better took pt to exam room & gave juice; seen by MD 29nov94;									Y	11/28/1994	11/28/1994	0	none;	PUB	PVT	theophylin; asmacort; proventil;	none;	none;	none;~ ()~~~In patient		1						1	Dizziness; Tachycardia	FLU3~CONNAUGHT LABORATORIES~4F51164~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069368	12/06/1994	OR	28.0	28		F	11/08/1994	pt recvd vax; 2 wks later devel severe joint pain; mild sore throat; shooting pain from inject site, neck, lower arm; sxs began resolving 4-5 days after onset; now resolved;									Y	10/06/1994	10/20/1994	14	none;	OTH	PVT	nk;	none;	none;	in pt, same sxs but much milder after flu shot 1 yr ago;~ ()~~~In patient		1						1	Arthralgia; Injection site pain; Neck pain; Pain; Pharyngitis	FLU3~PARKE-DAVIS~01664P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0069370	12/07/1994	WA	41.0	41		M	12/06/1994	pt recvd vax;approx 48 hrs after vax exp productive cough,rhinorrhoea;gi upset,n w/ recurrent emesis & d lasting approx 5-7 days;diabetic control was also disrupted;diabetes remain diff to control at time of rept;rantidine was initiated;									N	10/19/1994	10/22/1994	3	none;	OTH	OTH	ranitidine; hydrochloride;insulin;benazapril;	diabetes,obesity,gi reflux,hyperlipidaem	diabetes type II,obesity,gi reflux,hyperlipidaemia & gout;	~ ()~~~In patient	AL94231	1						1	Condition aggravated; Cough; Diarrhoea; Dyspepsia; Nausea; Rhinitis; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E2504GB~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0069371	12/07/1994	CA	50.0			F	10/28/1994	pt recvd vax;devel large localized rxn consisting of erythema, swelling, tenderness approx 7 hrs after vax; cbc revealed wbc of 18.1; hosp 2 days;rx ancef;MD rept not a case of cellulitis but possibly arthus rxn;had been immun w/ ppv in 93;				Y	Y	2			N	10/19/1994	10/19/1994	0	cbc:wbc 18.1;	PVT	PVT	na;		copd, asthma;	~ ()~~~In patient	940225602	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Leukocytosis; Serum sickness	FLUX~UNKNOWN MANUFACTURER~~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~376967~2~IM A~~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0069377	12/07/1994	VA	52.0	52		F		pt recvd vax;1nov tingling in feet & toes progressing to paresthesia;weakness & diff walking noted 11nov;& weakness of hands;incontinence of stool & urine noted w/ strain or cough;c/o sore throat & constriction of throat & diff swallowing;					Y	8			U	10/18/1994	11/01/1994	14		PVT	PVT	glucatrol, synthroid, biaxin, estrogen, progesterone;	none;	diabetes mellitus, hypertension, hypothyroidism;	~ ()~~~In patient		1						1	Asthenia; Dysphagia; Faecal incontinence; Gait disturbance; Laryngospasm; Paraesthesia; Pharyngitis; Urinary incontinence	FLU3~PFIZER\WYETH~4948119~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0069378	12/07/1994	OH	38.0	38		M	12/05/1994	pt recvd vax; 5-6 wks(ongoing) muscle fatigue,primarily shoulder gridle & calves along w/ diffuse fasciculations except for polyclonal inc of gamma globulin protein fraction; esr 12;exam by internist & neurologist neg;				Y					N	10/24/1994	10/31/1994	7		OTH	OTH	none;	none;	none;	~ ()~~~In patient		1						1	Immunoglobulins increased; Muscle twitching; Myasthenic syndrome	FLU3~PARKE-DAVIS~00474P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0069379	12/07/1994	VA				U	11/28/1994	pt recvd vax 7nov94, devel cold, constant nasal drainage, chills, chest tightness; buzzing in ears;about 1 wk after inject; 28nov94 cont to feel badly w/ t of 99.3;										11/07/1994				UNK	UNK				~ ()~~~In patient		1						1	Chest pain; Chills; Malaise; Pharyngitis; Pyrexia; Rhinitis; Tinnitus	FLU3~CONNAUGHT LABORATORIES~4F51089~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069381	12/08/1994	LA	41.0	41		F	11/03/1994	pt recvd vax; devel welts from inject site up into hair line; instructed to go to hlth deept or er; to er for evaluation;				Y					Y	11/02/1994	11/02/1994	0	unk;	PUB	PUB	unk;	none;	asthma;	~ ()~~~In patient	LA941202	1						1	Injection site hypersensitivity; Urticaria	FLU3~PFIZER\WYETH~4948130~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0069383	12/08/1994	MA	52.0	52		F	11/29/1994	pt recvd vax; c/o discomfort of rt arm (throbbing, burning, aching) which began approx 1 wk following vax;reported to school RN 28nov94;refered to MD that day who advised to use warm packs PRN;may take apap/asa for discomfort;				Y					U	11/03/1994	11/11/1994	8	none;	PUB	PUB	none;	none;	none;	in pt,same rxn in oth arm last yr but had been previously injured on neck area;~ ()~~~In patient	MA9437	1						1	Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~4F51016~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069387	12/08/1994	SD	64.0	64		M	11/17/1994	pt recvd vax at 1:30pm;by 5:30pm was having shortness of breath,hard productive cough & heart was beating fast;sxs got worse & to hosp;testing revealed no trouble w/ heart;dph given & sxs subsided;				Y					Y	11/16/1994	11/16/1994	0	ekg nl;	PUB	PUB		none;	none;	~ ()~~~In patient	SD94038	1						1	Cough; Dyspnoea; Tachycardia	FLU3~CONNAUGHT LABORATORIES~4F51025~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069389	12/08/1994	CA	75.0			F		pt recvd vax on 23nov94; felt ill by next day; to hosp   28nov94 w/ leg paralysis; pt dx w/ idiopathic transverse myelitis of the spine;as of 1dec94 sxs improved but remained hosp;			Y		Y			Y		11/23/1994	11/28/1994	5	30nov elevated ck(232 u/l);29nov csf total protein elevated (112 mg/dl);	UNK	UNK				~ ()~~~In patient		1						1	Blood creatine phosphokinase increased; CSF test abnormal; Malaise; Myelitis; Paralysis	FLU3~PFIZER\WYETH~4948120~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0069392	12/08/1994	VA	73.0	73		F	11/25/1994	pt recvd vax; chills, aching all over; severe h/a; t of 100;				Y					N	11/18/1994	11/19/1994	1	cbc nl;	PVT	PVT				in pt, same rxn to flu vax in 1993;~ ()~~~In patient		1						1	Chills; Headache; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51129~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069403	12/08/1994	LA	33.0	33		F	12/02/1994	pt recvd vax; inject site devel erythema, warmth & 100 mm induration; site was painful; all sxs resolved approx 4 days after vax;									Y	11/06/1994	11/07/1994	1	none;	PVT	PVT	none;	none;	none;	none;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4948040~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0069404	12/08/1994	IN	79.0	79		F	12/05/1994	pt recvd vax; states cold ever since shot; yellow rhinorrhea x 1 mo;tx w/ atb;									U	10/24/1994	10/25/1994	1	na;	PVT	PVT				unk;~ ()~~~In patient		1						1	Pharyngitis; Rhinitis	FLU3~PFIZER\WYETH~4948316~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0069015	12/09/1994	CO	58.0	58		F	11/17/1994	pt recvd vax;devel rash at back of both hands;spread to entire back of hands,wrist & 1/4 forearms;patches on lower trunk & legs also;hands,arms became firery red,swollen & mild itchy;oth areas red,raised;sxs lasted 2 wks;tx cortizone,cold p				Y					Y	10/22/1994	10/28/1994	6		OTH	OTH	premarin, provera;	none;		~ ()~~~In patient	CO94076	1						2	Arthritis; Vasodilatation; Oedema peripheral; Pruritus; Rash; Rash maculo-papular; Vasodilatation	FLU3~PFIZER\WYETH~4948145~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4948145~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0069415	12/09/1994	CA	43.0	43		F	11/01/1994	pt recvd vax;approx 3 hrs later devel cough,eyes felt like sand in them,blurred vision,constricting in throat w/ trouble swallowing,swelling of face;now lips numb but swelling down;Md thought conjunctivitis part of diff situation;pt better;										10/31/1994	10/31/1994	0		PUB	PUB	none;	not that pt was aware;	none;	in pt, 15 yrs ago had rxn to swine flu vax,had flu sxs;for 6 mo had pain in arm;~ ()~~~In patient	CA94146	1						1	Amblyopia; Conjunctivitis; Cough; Dysphagia; Eye pain; Face oedema; Laryngospasm; Paraesthesia oral	FLU3~CONNAUGHT LABORATORIES~4F51025~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069417	12/09/1994	CA	63.0	63		F	11/02/1994	pt recvd vax; w/in hrs of vax pt started exp fever, chills, joints aches, n, rt arm painful at inject site;				Y						11/02/1994	11/02/1994	0		OTH	PUB	cardizan, diuretic,baby asa hydric;	PMH: leukemia;	leukemia;	none;~ ()~~~In patient	CA94148	1						1	Arthralgia; Chills; Injection site pain; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0069418	12/09/1994	CA	63.0	63		F	10/26/1994	pt recvd vax; devel rt arm rash urticarial over 90% of arm; mild swelling but pt reported twice the swelling the noc before;pt reported pruritus & pain in rt shoulder & neck;pc to pt 10nov94,swelling resolved after 1 wk & 4 days for itching									Y	10/24/1994	10/24/1994	0	none;	OTH	OTH	premarin; relafin;	none at time of vax;	nkda; obesity, irritable bowel, peptic ulcer disease;	~ ()~~~In patient	CA94149	1						1	Injection site hypersensitivity; Neck pain; Oedema; Pain; Pruritus	FLU3~CONNAUGHT LABORATORIES~4F51025~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~358959~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0069419	12/09/1994	CA	25.0	25		F	11/08/1994	pt recvd vax; c/o heaviness & tingling in leg approx 1 hr after vax;									Y	11/01/1994	11/01/1994	0		PUB	PUB	none;	none;		na;~ ()~~~In patient	CA94150	1						1	Myasthenic syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51008~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069421	12/09/1994	CA	80.0	80		F	11/04/1994	pt recvd vax; fever, aches all over; h/a, redness of throat; pleursy pains in chest; dizzy started 2 days after vax; 7nov94 pc to pt this am regarding flu-like sxs;cont to have sore throat;app to see PMD;8nov pc to pt,improved; atb given;				Y						11/02/1994	11/04/1994	2		PUB	PUB	ogen, vits;	none;	allergies to meds(numerous); resp problems;	none;~ ()~~~In patient	CA94152	1						1	Dizziness; Headache; Influenza; Myalgia; Pain; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51016~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069422	12/09/1994	CA	70.0	70		F		pt recvd vax; inc t, n, h/a, weakness x 3 1/2 days;									Y	10/17/1994	10/17/1994	0		PUB	PUB	mecavor, zantac, maxine, baby asa;	none;	none;	~ ()~~~In patient	CA94153	1						1	Asthenia; Headache; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51016~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069423	12/09/1994	CA	67.0	67		F	11/09/1994	pt recvd vax;4 hrs later,became SOB w/ itchy eyes;seen in ER;expiratory wheezes;sclera & eyelids injected;hx cig smoking;tx proventil x 3,decason,IV,DPH,prednisone;p/ aerosol tx lung & whezzes clear;dx hypersensitive rxn to flu vax;				Y					Y	11/08/1994	11/08/1994	0	02 sat=94	PUB	PUB	metoclopramide;	none;	pcn, IVP dye;	none;~ ()~~~In patient	CA94154	1						1	Asthma; Conjunctivitis; Dyspnoea; Hypersensitivity; Hypoxia; Pruritus	FLU3~CONNAUGHT LABORATORIES~4F51072~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069424	12/09/1994	CA	40.0	40		F	11/16/1994	pt recvd vax;c/o weakness 2-3 mins later;sat inc diaphoresis,pale,HR dec 36-38;BP 88-90; pt lost consciousness & had tonic clonic mvts time from LOC to responsiveness 90 secs;on floor & feet elev;returned to nl HR & BP limits w/in 3 mins;				Y					Y	11/15/1994	11/15/1994	0	CAT scan, labs, EKG;	PUB	PUB		none;	none;	~ ()~~~In patient	CA94155	1						1	Asthenia; Bradycardia; Hyperhidrosis; Hypertonia; Hypotension; Hypotonia; Pallor; Syncope	DT~LEDERLE LABORATORIES~356904~UNK~~LA~DT ADSORBED (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~4F51008~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069425	12/09/1994	CA	53.0	53		F	11/23/1994	pt recvd vax; lt arm swelled & turned red; seen urgent care; put on dicloxicillin; somewhat better;									Y	11/18/1994	11/18/1994	0		OTH	PUB	glyburide	aodm, hypothyroid;	aodm, hypothyroid;	~ ()~~~In patient	CA94156	1						1	Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51025~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~4G61080~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0069426	12/09/1994	CA	42.0	42		F	11/22/1994	pt recvd vax 28oct94,woke up 29oct w/ feet tingling,feeling asleep & heavy;stayed home for 1 wk; tingling in hands on & off but gone when started on tegretol by neurologist;				Y					N	10/28/1994	10/29/1994	1	none;	PUB	PUB	amatidine; tegretol;		mult sclerosis;	~ ()~~~In patient	CA94157	1						1	Myasthenic syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51025~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069428	12/09/1994	CA	44.0	44		M	11/17/1994	pt recvd vax; 48 hrs later, sore at inject site w/ shooting numbness tingling down arm intermittently at 1st; now,1wk later,numbness & tingling remain & is almost constant,c/o thumb being on the verge of numb;									U	11/03/1994	11/05/1994	2		PUB	PUB		none;		none;~ ()~~~In patient	CA94159	1						1	Injection site pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51025~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069432	12/09/1994	CO	20.0	20		M	10/19/1994	pt recvd vax; h/a, n, faint, tremors, arms numb, tachycardia, t of 104.7, BP 110/48; tx DPH, toradal, solumedrol, adm to hosp 18oct; released 20oct94;				Y	Y	2			Y	10/18/1994	10/18/1994	0		MIL	MIL	none;	sore throat x 3 days;	none;	~ ()~~~In patient	CO94074	1						1	Dizziness; Headache; Hypotension; Nausea; Paraesthesia; Pyrexia; Tachycardia; Tremor	FLU3~PARKE-DAVIS~00284P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~PFIZER\WYETH~4938213~2~A~~TD ADSORBED (NO BRAND NAME)~1|TYP~PFIZER\WYETH~4948192~2~A~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0069433	12/09/1994	CO	42.0	42		M	11/01/1994	pt recvd vax; 12oct @ 5pm;awake at 1am 13oct w/ severe SOB, wheezing;unable to work or have any exertion w/o worsening sxs; to MD & tx w/ inhaler;cont to exp tightness & wheezing;to see PMD for assessment;				Y					U	10/11/1994	10/12/1994	1		PUB	PUB		none;	was tx in 1984 for newsprint lent causing SOB;	~ ()~~~In patient	CO94075	1						1	Asthma; Dyspnoea; Pain	FLU3~CONNAUGHT LABORATORIES~4F51165~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069442	12/09/1994	CA	31.0	30		F	11/22/1994	1 1/2 wks p/vax diarrhea 4 stools q day; saw gastroenteologist; MD rxed Donnatal-Lomotil;				Y					U	10/06/1994	10/14/1994	8		OTH	PVT	APAP #3; Valium, Donnatal, Phenegen, Extertol, Tagamet, Tobrex, Pyridium, Paxil;	chron's disease, colon polyp, ovarian tu	MVP, poss heart block, PUD, cyctitis, migraines, allergic sulfa, TCN, ETN, DPH	NONE~ ()~~~In patient		1						1	Diarrhoea	FLU3~PFIZER\WYETH~4948120~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0069446	12/09/1994	WY	67.0	67		F	12/05/1994	redness, tenderness, 2-10cm in size;									Y	11/14/1994			NA	PVT	PVT	Niacin	NA	Hyperlipidemia	~ ()~~~In patient		1						1	Pain; Vasodilatation	FLU3~PFIZER\WYETH~4948147~UNK~SC A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0068426	12/12/1994	MA	82.0	82		F	11/08/1994	pt recvd vax;approx 6 hrs later,diaphoretic & nauseous;mult episodes of v;devel weakness;in ofc;c/o inflammation of legs;syncopal while in waiting rm,pale,BP 110/78;P68;O2 given;questionable petechiae on lower extremities;to er & stable;				Y	Y	2			Y	10/26/1994	10/26/1994	0	eosinophils 14%=197. repeated on 4nov in ofc 8.57..; platelet count remained WNL throughout;	OTH	PUB	timoptic(topical);	tx for URI 3 wks prior to 3oct;	none;	~ ()~~~In patient	MA9438	1						2	Asthenia; Eosinophilia; Hyperhidrosis; Orthostatic hypotension; Pallor; Petechiae; Syncope; Vomiting; Asthenia; Eosinophilia; Hyperhidrosis; Nausea; Pallor; Petechiae; Syncope; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51165~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~4F51165~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0068924	12/12/1994	MD	60.0	60		M	12/05/1994	pt began to have bleeding gums in 4NOV94 & this was much worse by 7NOV94 which pt went to MD & then to hematologist who gave pt steroids & pred p/discharge from hosp; pt dx IPT caused by auto immune system react of some kind; BS elevated;					Y	3			U	10/27/1994	11/04/1994	8	CBC showed dec in platelets to 4,000	OTH	OTH	ASA; TOlinase; Diphenoxylic;	NONE	diabetes mellitus,II; to cephalosporins	pt exp react in flu vax in 1993;~ ()~~~In patient		1						2	Gingival bleeding; Thrombocytopenia; Thrombocytopenic purpura; Condition aggravated; Gastrointestinal haemorrhage; Gingival bleeding; Immune system disorder; Thrombocytopenia; Thrombocytopenic purpura	FLU3~PFIZER\WYETH~4948197~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4948197~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0069452	12/12/1994	AL	68.0	68		F	11/14/1994	pt recvd vax;approx 1 hr later,itching w/ rash breaking out on arms then all over body;red,raised wheals over face,arms,hands,back,shoulders,stomach,legs & feet;c/o upper lip numb & swollen;to er,dx w/ allergic rxn to flu vax;tx DPH & corti				Y					Y	11/12/1994	11/12/1994	0	no dx test or labwork done in er;	OTH	PUB	naprosyn; flexaril;	sinus drainage;	arthritis;	none;~ ()~~~In patient	AL9443	1						1	Face oedema; Hypersensitivity; Paraesthesia oral; Pruritus; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51024~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069456	12/12/1994	IL	63.0	63		F	11/16/1994	pt recvd vax; throat tightened; difficulty swallowing; pain in joint; bruising of upper lt arm;									Y	11/09/1994	11/09/1994	0	none;	PUB	PUB	thyroid, levathroid, provera;	none;	pork; maybe eggs per MD on 15nov94;	none;~ ()~~~In patient	IL940126	1						1	Arthralgia; Dysphagia; Ecchymosis; Laryngospasm; Injection site oedema; Injection site pain; Laryngospasm; Muscle spasms; Myalgia; Pain; Skin discolouration	FLU3~CONNAUGHT LABORATORIES~4F51016~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~4F51016~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0069463	12/12/1994	IL	53.0	53		M	11/17/1994	pt recvd vax;became ill at 8pm w/ low abdo pain; emesis (projectile x 2), diarrhea x 4, lasted for 3 hrs;had SOB; was not seen by MD or in er;									Y	11/16/1994	11/16/1994	0		PUB	UNK	humulin; lasix; norvasic;	none;	diabetic, kidney disease; congestive heart disease;	~ ()~~~In patient	IL940134	1						1	Abdominal pain; Diarrhoea; Dyspnoea; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51022~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069464	12/12/1994	IL	64.0	63		F	11/16/1994	pt recvd vax;hands itch intensely,severe abdo pain followed by diarrhea,v x 2;became pale & clammy;tongue & lips began to swell & throat seemed to be narrowing; to er;later sxs subsided;adm decadron LA,DPH given;				Y					Y	11/10/1994	11/10/1994	0	none;	PUB	UNK	calan SR; premarin; provera;	none;	none;	none;~ ()~~~In patient	IL940135	1						1	Abdominal pain; Diarrhoea; Face oedema; Hyperhidrosis; Laryngospasm; Pruritus; Tongue oedema; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51022~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~378974~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0069466	12/12/1994	IL	63.0	63		F	11/18/1994	pt recvd vax; devel rt leg numbnesss on 7nov94; BP 210/90;started on anti-hypertensive; 8nov94 numbness spread from under breast line to lower extremities bilaterally;					Y				U	11/03/1994	11/07/1994	4		OTH	OTH		none;	none;	~ ()~~~In patient	IL940137	1						1	Anxiety; Asthenia; Hypertension; Paraesthesia	FLU3~PARKE-DAVIS~00374P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0069468	12/12/1994	MA	72.0	72		M	11/17/1994	pt recvd vax; exp chills, shakes, fever of 102;v; shot was given at 1:15pm; sxs started 6pm; given extra strenght apap;									Y	10/26/1994	10/26/1994	0		PUB	UNK	vasotec;		high blood pressure;	~ ()~~~In patient	MA9439	1						1	Chills; Pyrexia; Tremor; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069469	12/12/1994	MI	67.0	67		M	10/27/1994	pt recvd vax at 2pm; at 6:30pm suddenly became SOB,started coughing,had chills;fever 100;rt arm swollen hot & had great difficulty moving it; aspirin given then slept;pt better;still cough & lusky voice;3 diam red swollen on rt arm at site									Y	10/26/1994	10/26/1994	0		PUB	PUB	none;	none;	none;	none;~ ()~~~In patient	MI94148	1						1	Chills; Cough; Dyspnoea; Hypokinesia; Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51059~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1474W~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0069472	12/12/1994	MI	46.0	46		F	10/24/1994	pt recvd vax;arm sore next am;about 10am soreness & swelling noted at inj site;about 4pm noticed swelling all around upper arm; elbow very hot & painfull;seen at prime care;given lodine for pain;told to use sling;apply ice for swelling;				Y					Y	10/21/1994	10/22/1994	1		PUB	PUB	premarin, lente humlin, insulin;	none;	pcn allergy; diabetes (insulin dependent);	~ ()~~~In patient	MI94152	1						1	Injection site oedema; Injection site pain; Myalgia; Vasodilatation	FLU3~PARKE-DAVIS~01664P~7+~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~378977~1~SC~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0069476	12/12/1994	MI	67.0	67		F	10/28/1994	pt recvd vax; 1/3 tongue (front) began to tingle; dec taste; very small blister like lesion; tingling &  dec of taste remains;saw MD on 25oct; MD said rxn from flu shot;				Y					N	10/03/1994	10/05/1994	2	none;	PUB	PVT	thyroid low dose;	none;	none;	~ ()~~~In patient	MI94157	1						1	Ageusia; Dermatitis bullous; Paraesthesia oral	FLU3~CONNAUGHT LABORATORIES~4F51165~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069477	12/12/1994	MI	54.0	54		F	10/27/1994	pt recvd vax; exp chills, fever, diarrhea, sore throat,cough,difficulty sleeping x 6 days; still very tired, voice not back to nl;									Y	10/21/1994	10/21/1994	0	none;	PUB	PVT	none;	none;	erthromycin, xylocaine & codeine;	~ ()~~~In patient	MI94158	1						1	Asthenia; Chills; Cough; Diarrhoea; Dysphonia; Insomnia; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51165~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069478	12/12/1994	MI	27.0	27		F	10/06/1994	pt recvd vax & began to have dazed/lightheaded feeling;rt arm only had a burning sensation & was swollen & red around site;swelling inc to 3;8-9pm feel short of breath;rn called;to er,given meds;pt feels fine now;				Y					Y	10/04/1994	10/04/1994	0	none;	PUB	PUB	none;	none;	allergy to codeine;birth defect;deformed spleen; no oth conditions;	none;~ ()~~~In patient	MI94159	1						1	Dizziness; Dyspnoea; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~4F51165~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~378977~2~SC~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0069479	12/12/1994	MI	67.0	67		M	10/27/1994	pt recvd vax;early eve,large lump at inj site;by early am,rt elbow to shoulder swollen w/ little redness;no pain;by 4pm still reddened,flexall applied;PC MD;28oct arm reddened & firm;in hosp for cellulitis;had t & chills;given ATB;				Y	Y	5			Y	10/26/1994	10/26/1994	0		PUB	UNK	klonopin, depakote, vasotec, ventolin,ASA;	? chronic emphysema;	? asthma, HTN, angina, prostate surgery sep94;	none;~ ()~~~In patient	MI94160	1						1	Cellulitis; Chills; Injection site hypersensitivity; Injection site mass; Injection site oedema; Oedema peripheral; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51165~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1474W~2~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0069480	12/12/1994	MI	87.0	87		F	11/10/1994	pt recvd vax; inject site where vax given was blue, swollen, very hot to touch;arm swollen from elbow to upper arm;PHN instructed to take pt to MD;will take to walking er today;f/u arm still bit swollen;pt has also been sick to stomack;									N	11/09/1994	11/09/1994	0		PUB	PUB	none;	none;	none;	none;~ ()~~~In patient	MI94161	1						1	Dyspepsia; Injection site oedema; Skin discolouration; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51059~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~378977~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0069483	12/12/1994	MI	66.0	66		F	11/04/1994	pt recvd vax; woke up in severe pain rt side radiating to back; spasms/pain cont for 2 hrs; subsided when took apap; saw MD 1nov94MD did not feel due to flu vax but did lots of tests;cont nauseated & apin behind Lt arm as of 4nov94;				Y					N	10/31/1994	10/31/1994	0	chest x-ray, blood tests, liver tests, EKG, urinalysis all neg;	PUB	UNK	thyroid;	? cold sxs;	hypothyroidsm?; no per client statement; rt breat biopsy 2 wks prior to flu vax;	none;~ ()~~~In patient	MI94165	1						1	Back pain; Hypertonia; Nausea; Pain	FLU3~CONNAUGHT LABORATORIES~4F51059~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069491	12/12/1994	MS	62.0	61		F	11/07/1994	redness & swelling around inject site on rt deltoid; hives on face, arms, neck, torso (anterior & posterior); advised to be seen by MD for eval; attempted f/u w/phone call 8NOV94 but phone # given was disconnected;				Y					U	11/04/1994	11/06/1994	2		PUB	PUB		NONE	NKA	~ ()~~~In patient	MS94067	1						1	Injection site hypersensitivity; Injection site oedema; Urticaria	FLU3~PARKE-DAVIS~02894P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~1682W~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0069494	12/12/1994	NC	33.0	33		F	11/23/1994	knot-egg shaped on area given red itching, hot;									Y	11/21/1994	11/22/1994	1	NONE	PUB	PVT		NONE	dust, mold	~ ()~~~In patient	NC94136	1						1	Injection site hypersensitivity; Injection site mass; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4948145~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0069497	12/12/1994	OK	63.0	63		F	11/14/1994	2 days p/inject pt started having severe pain in upper arm, shoulder & back of neck; referred pt to MD;				Y					U	11/02/1994	11/04/1994	2		PUB	PUB	Ventolin	NONE	Asthma	NONE~ ()~~~In patient	OK9467	1						1	Neck pain; Pain	FLUX~UNKNOWN MANUFACTURER~E2504GE~5~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~CONNAUGHT LABORATORIES~4C61075~UNK~IM~~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0069501	12/12/1994	TN	65.0	65		F	11/18/1994	approx 3 days p/vax lt arm painful down to elbow approx 1 wk later, pain down to fingers tips, vomited x 1-went to hosp, BP 235/56 @ hosp since then intermittent pain down to elbow, relieved by ASA; pt is beautician noted pain today @ work				Y					U	10/31/1994	11/01/1994	1	Blooddrawn, EKG	PUB	OTH	Premarin	NNE	NONE	NONE~ ()~~~In patient	TN94157	1						1	Hypertension; Injection site pain; Pain; Vomiting	FLU3~PFIZER\WYETH~4948116~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0433A~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0069504	12/12/1994	WV	65.0	65		M	12/06/1994	48 hrs p/vax-sore across back of neck-24 hrs later couldn't use rt arm; seen by MD said nerve damage due to Td-stated may take 12-15 months to go away				Y					Y	11/02/1994	11/04/1994	2		PUB	PUB	Allopurinol for gout; high blood pressure Relefen; Ziac, Glynase for diabetes, arthritis			~ ()~~~In patient	WV9433	1						1	Hypokinesia; Neck pain; Neuropathy	FLU3~PFIZER\WYETH~4948130W~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~4B61052C~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0069508	12/12/1994	CA	50.0	50		F	11/15/1994	2 hrs post-discomfort, erythema lt arm; 24 hrs post-swelling, heat, erythema lt arm, induration size of a quarter t98.6-given Ancef; 30 hrs post-t101, WBC 18.1 amd to hosp for further IV ATB; 48 hrs post-erythema, edema dec;				Y	Y	2			Y	10/19/1994	10/19/1994	0	No blood culture, sputum-nl; 20OCT WBC 18.1; granulocytes 10.5; 22OCT WBC 10.2; granulocytes 6.7; 28OCT WBC 13.9;	OTH	OTH	Synthroid 01.mg po qd; Alupent MDI 2-4 puffs q 4 hrs;		asthma, emphysema, hypothyroidism; allergic codeine	NA~ ()~~~In patient		1						1	Leukocytosis; Oedema peripheral; Pain; Pyrexia; Rash; Skin nodule; Vasodilatation	FLU3~PARKE-DAVIS~00474P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~376967~2~SC~LA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0069509	12/12/1994	LA	34.0	34		F	12/05/1994	2.5 cm lesion on the rt brain stem; paralysis on lt side of body; Pred given;					Y	3			N	09/27/1994	09/30/1994	3		UNK	UNK		NONE	NONE	~ ()~~~In patient		1						1	Brain stem syndrome; Paralysis	FLU3~CONNAUGHT LABORATORIES~4948106~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0069521	12/12/1994	CA	52.0	52		M	11/15/1994	pain under lt shoulder blade-down inside of arm to hand; numb elbow & fingers; 1DEC94 elbow still numb-thumb & lt 2nd finger nubm-pain in elbow mostly gone;				Y					Y	10/19/1994	10/19/1994	0	EMG-mild rt radial neuropathy;	OTH	OTH	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Neuropathy; Pain; Paraesthesia	FLU3~PARKE-DAVIS~00474P~1~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~376967~1~A~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0069522	12/12/1994	CA	40.0			F	11/15/1994	w/in 24 hrs devel pain, 8cm erythema & swelling lt arm shoulder-elbow, also devel lt axillary adenitis; tx symptomatically;				Y					Y	10/19/1994	10/20/1994	1	NONE	OTH	OTH	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Lymphadenopathy; Oedema peripheral; Pain; Rash	FLU3~PARKE-DAVIS~00474P~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~376967~1~~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0069523	12/12/1994	CA	64.0	64		F	11/15/1994	rt arm gland irritated, could not lift rt arm, swelling & painful could not lift; severe h/a & very weak; dx'd pneumonia;				Y					Y	10/19/1994	10/20/1994	1		OTH	OTH	NONE	NONE	NA	NONE~ ()~~~In patient		1						1	Asthenia; Headache; Hypokinesia; Lymphadenopathy; Oedema peripheral; Pain; Pneumonia	FLU3~PARKE-DAVIS~00474P~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~376967~1~~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0069524	12/12/1994	CA	28.0	28		F	11/15/1994	devel swelling >3cm @ site w/erythema, mod-marked swelling & tenderness of axillary nodes & marked generalized myalgia; was seen by local urgent care & given symptomatic treatment;				Y					Y	10/19/1994	10/19/1994	0	NONE	OTH	OTH	Motrin	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Lymphadenopathy; Myalgia	FLU3~PARKE-DAVIS~00474P~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~376967~1~~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0069525	12/12/1994	CA	31.0	31		F	12/06/1994	began w/pain @ site, rapidly progressing to erythema, & swelling; cellulitis from elbow to shoulder present w/in 36 hrs; treated w/Rocephin & dicloxacillin- resolved w/in 5 days				Y					Y	10/19/1994	10/19/1994	0	NA	OTH	OTH	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~00474P~2~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~376967~1~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0069526	12/12/1994	MI	49.0	49		F	11/29/1994	starting on 22OCT94 pt c/o chills, h/a, backache, cough which occurred again on 11, 18NOV; same sx appeared each time;									Y	10/19/1994	10/22/1994	3		PUB	PUB			Not known	~ ()~~~In patient		1						1	Back pain; Chills; Cough; Headache	FLU3~CONNAUGHT LABORATORIES~4F511165~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069530	12/12/1994	NC	37.0	37		F	12/06/1994	24 hrs p/vax; pt devel erythematous mac pap rash on face-progressed to head & neck;									U	12/04/1994	12/05/1994	1		MIL	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						1	Rash maculo-papular	FLU3~PARKE-DAVIS~00474P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0069532	12/12/1994	CA	31.0	31		F	12/02/1994	devel 3cm area eythema @ site w/ 7/10 tenderness & 3cm swelling; devel lymphadenopathy axillae & groin & medmarked myalgias;									Y	10/19/1994	10/19/1994	0	NONE	PVT	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Lymphadenopathy; Myalgia	FLU3~PARKE-DAVIS~00474P~1~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~376967~1~A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0069533	12/12/1994	CA	46.0	46		M	11/15/1994	Thurs had severe bone & muscle pain-used APAP #3 3-had to go wear jacket last 2 hrs of shift secondary to chills; no fever; Friday couldn't get out of bed secondary/arthralgia (+) nausea; no vomiting-on Saturday dec myalgia but lt arm itchy									Y	10/19/1994	10/20/1994	1	NONE	OTH	OTH	Synthroid;	NONE	THyroid dse	NA~ ()~~~In patient		1						1	Arthralgia; Bone pain; Chills; Myalgia; Nausea; Pruritus	FLU3~PARKE-DAVIS~00474P~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~376967~1~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0069534	12/12/1994	CA	33.0	33		F	11/15/1994	missed 2 days of work-got fever 101-103 all upper trunk muscles ached, clear to waist & trouble getting to sitting position; lasted 2 1/2 days-no local react									Y	10/19/1994	10/23/1994	4	NONE	OTH	OTH	NONE-Modecon BCP	NONE	allergy PCN;	~ ()~~~In patient		1						1	Myalgia; Pyrexia	FLU3~PARKE-DAVIS~00474P~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~376967~1~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0069535	12/12/1994	CA	46.0	46		F	12/02/1994	lt arm got all swollen & got a hard central knot, t101 24 hrs-48 hrs devel harder lt axillary lymph node, devel nausea, myalgias weakness & fever broke w/diaphoresis; gradually improved, sx gone 5 days;									Y	10/19/1994	10/20/1994	1		PVT	OTH	Trenalin, Dyazide, Premarin	NONE	HTN, s/p hysterectomy allergic PCN	NA~ ()~~~In patient		1						1	Asthenia; Hyperhidrosis; Lymphadenopathy; Myalgia; Nausea; Oedema peripheral; Pyrexia; Skin nodule	FLU3~PARKE-DAVIS~00474P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~376967~2~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0069536	12/12/1994	CA	67.0	67		F	11/15/1994	had red & swollen arm, swollen gland under lt arm, t102 for 24 hrs starting 19OCT94; came back to work on 10-20 & lt work for 2 hrs-temp back;									Y	10/19/1994	10/19/1994	0	NONE	OTH	OTH		NONE	HBP	NONE~ ()~~~In patient		1						1	Lymphadenopathy; Oedema peripheral; Pyrexia; Vasodilatation	FLU3~PARKE-DAVIS~00474P~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~376967~1~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0069537	12/12/1994	CA	49.0	49		F	11/15/1994	swollen, achey arm, fever, weakness, swollen glands under armpits for the duration of 2-3 days; took APAP, Motrin; a few days later had flu for 3 days w/fever, cold, cough; took APAP over the counter cold med									Y	10/19/1994	10/20/1994	1		OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Asthenia; Cough; Influenza; Lymphadenopathy; Myalgia; Oedema peripheral; Pharyngitis; Pyrexia	FLU3~PARKE-DAVIS~00474P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~376967~UNK~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0069538	12/12/1994	CA	66.0	66		F	11/15/1994	redness, tenderness, swelling @ inject site; some muscle aches in shoulders for 1 1/2 days;									Y	10/19/1994	10/19/1994	0		OTH	OTH	NON	NONE	NONE	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia	FLU3~PARKE-DAVIS~00474P~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~376967~1~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0069539	12/12/1994	CA	35.0	35		M	11/15/1994	redness, tenderness, swelling @ site of inject; some lymph node swelling & tendernss in lt axilla which lasted 2 days;									Y	10/19/1994	10/20/1994	1		OTH	OTH	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Lymphadenopathy	FLU3~PARKE-DAVIS~00474P~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~376967~1~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0069540	12/12/1994	CA	45.0	45		M	11/15/1994	sl soreness p/shot-by evening arm was sore & felt heavy; following morning unable to arm-arm neither red or hot, sl swollen; sx improved w/in 24 hrs; missed one day of work;									Y	10/19/1994	10/19/1994	0	NA	OTH	OTH	NONE	NONE	chronic hepatitis-BC	NONE~ ()~~~In patient		1						1	Hypokinesia; Myalgia; Myasthenic syndrome; Oedema peripheral	FLU3~PARKE-DAVIS~00474P~1~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~376967~1~A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0069541	12/12/1994	CA	46.0	46		F	11/15/1994	swelling on arm size of fifty cents piece, painful pruritic, lasted 2-3d; used DPH the first noc since had swelling of arm w/flu shot last year;									Y	10/19/1994	10/20/1994	1	NA	OTH	OTH	NONE	NONE	allergic PCN	pt exp react @ 45 y/o w/flu vax;~ ()~~~In patient		1						1	Oedema peripheral; Pain; Pruritus	FLU3~PARKE-DAVIS~00474P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~376967~1~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0069542	12/12/1994	CA	33.0	33		F	11/15/1994	21OCT rt arm swelled up, fever, sweats in noc, hurt all over, nausea & dizziness; tender arm in AM & couldn't raise arm, found large knot in armpit; arm got red, hot swollen-redness lt in 4d, swelling lasted 1 wk;									Y	10/21/1994	10/21/1994	0	NA	OTH	OTH	glyburide, Tegretol, Zoloft, APAP, Vivactal, Vit C, Tagamet	NONE	Bipolar disorder, Diabetis mellitus II	NONE~ ()~~~In patient		1						1	Dizziness; Hyperhidrosis; Hypokinesia; Nausea; Oedema peripheral; Pain; Pyrexia; Skin nodule	FLU3~PARKE-DAVIS~00474P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~376967~UNK~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0069543	12/12/1994	CA	40.0	40		F		in 24 hrs warm, swollen @ 48 hrs 4-5cm red, warm area @ site w/hard knot size of nickle, whole arm swelled up but no lymp adenopathy-started resolving in 72 hrs but didn't resolved completely for 1 wk; sx were worst between 48-72 hrs;									Y	10/19/1994	10/20/1994	1	NONE	PVT	OTH	FeSO4, Vit C	Anemia	sensitivity to codeine	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Oedema; Oedema peripheral; Vasodilatation	FLU3~PARKE-DAVIS~00474P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~376967~1~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0069550	12/13/1994	OR				F	11/18/1994	pt recvd vax & 2 wks later 17NOV94 pt dx w/aseptic meningitis; On f/u pt's physician states that pt is fully recovered; viral culture neg; pt was felt to have herpes simplex encephalitis; There is no evidence that illness was related to vax					Y				Y	11/03/1994	11/17/1994	14	viral cultures-neg so far	OTH	OTH	unk	unk		~ ()~~~In patient	894326001S	1						1	Encephalitis; Herpes simplex; Meningitis	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0069553	12/13/1994	TX	29.0	29		M	11/01/1994	started as small hive lt arm was sore waited 2 days got hot & cold flashes hive got bigger; called MD & describe area; MD instructed MD to take APAP or Ibuprofin; also DPH light pink;									Y	10/27/1994	10/27/1994	0	NONE	PUB	PUB	Clariton; Nsal core;IB propine;	NONE	allergies to many factors	pt exp reaction @ 18 yrs;~ ()~~~In patient	TX94504	1						1	Chills; Myalgia; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4948146~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|MMR~MERCK & CO. INC.~0534A~2~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PPV~PFIZER\WYETH~378980~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0069554	12/13/1994	TX	34.0	34		F		pt recvd vax 18OCT94 4PM; by 7PM noticed neck sore & by the next morning could hardly mve head w/in-pain; then felt approx a quarter size lump under lt jaw;										10/18/1994	10/18/1994	0	NONE	PUB	PUB	NONE	NONE	NONE	NA~ ()~~~In patient	TX94505	1						1	Hypokinesia; Neck pain; Skin nodule	FLU3~PFIZER\WYETH~4948131~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0536A~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0069555	12/13/1994	TX	69.0	69		F	10/31/1994	hives onset 24OCT94-31OCT94 & sore throat; dx URI-poss vax react; AMoxicillin;				Y					Y	10/19/1994	10/24/1994	5	NONE	PUB	UNK	Harmone	NONE	NONE	~ ()~~~In patient	TX94506	1						1	Pharyngitis; Urticaria	FLU3~PFIZER\WYETH~4948146~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~358959~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0069568	12/13/1994	TX	63.0	63		F	11/30/1994	sick to stomach; cold, high blood pressure-fast heartbeat hot tingling in hands, arms, back & neck-weakness, no appetite, lost 8 lbs, loose stools, sometimes sweat, unsteady movements-extremely nervous				Y	Y	1			Y	10/20/1994	11/09/1994	20	EKG-multiple labs-chest & shoulder xray;	PUB	PUB	Mevacor	NONE	Lanoxin for heart, ASA, hormones	pt exp react in 1992-93 @ 61 y/o w/ flu dose 1;~ ()~~~In patient	TX94521	1						1	Asthenia; Chills; Dyspepsia; Hypertension; Movement disorder; Nervousness; Paraesthesia; Tachycardia	FLU3~PFIZER\WYETH~4948131~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0068357	12/14/1994	CO	40.0	40		F	12/14/1994	4 days post vax pt to MD w/t101; blood test revealed worsening of pre-existing haemolytic anaemia & pt was hospitalized 28OCT94; candidate for liver transplant; MD stated pt's condition not related to vax however cannot be r/o as a cause;					Y				N	10/24/1994	10/28/1994	4	24OCT94 WBC 17.2; RBC 4.54, HGB 14, HCT 44.5, platelets 484, SGOT 160, ALK phos 199, total Bil 22, LDH 562, BUN 14, Creat 0.9; 28OCT94 WBC 24.9, RBC 3.17, HGB 11, HCT 31.4, platelets 366, total bil 42;	PUB	PVT	Pred, Danazol, Flagyl, Cipro, Hemaspan, Diflucan, Prilosec, Carafate, Procrit, Micronase, K-DUr, Coumadin, maxzide, Trilisate, xanas & restoril		cryptogenic cirrhosis, ulcerative colitis, portalvein thrombosis, autoimmune phenomena, haemolytic anaemia	~ ()~~~In patient	ALI94235	1						2	Aspartate aminotransferase increased; Blood alkaline phosphatase increased; Blood lactate dehydrogenase increased; Condition aggravated; Hyperbilirubinaemia; Leukocytosis; Pyrexia; Anaemia; Aspartate aminotransferase increased; Blood alkaline phosphatase increased; Blood lactate dehydrogenase increased; Condition aggravated; Hyperbilirubinaemia; Leukocytosis; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Hospitalisation	Influenza
0069456	12/14/1994	IL	63.0	63		F	12/10/1994	sx w/in 15-25 mins got a tight throat; 9NOV94 feeling as if something was stuck in throat; tx DPH- 6 hrs later severe leg & foot cramps-much pain-lasted 10 mins; ache in arm under side & dull pain; aching arm @ site of inject deep purple;				Y					U	11/09/1994	11/09/1994	0		PUB	UNK	Premarin, Provera, Levothroid	NONE	seafood, pork, wool	pt exp rash-dizzines, nausea @ 44 y/o w/flu dose 1; pt's sibling exp itching;~ ()~~~In patient		1						2	Arthralgia; Dysphagia; Ecchymosis; Laryngospasm; Injection site oedema; Injection site pain; Laryngospasm; Muscle spasms; Myalgia; Pain; Skin discolouration	FLU3~CONNAUGHT LABORATORIES~4F51016~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~4F51016~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0069549	12/14/1994	NJ	53.0			M	11/30/1994	pt recvd vax & 25NOV94 devel bloody mucous; 26NOV94 pt was hospitalized for appearance of dry blood in mouth & nose mucous; 26NOV94, platelet count was 5,000-same day platelet count dec further to 1,000; also exp petechiae on extremities;					Y				N	11/01/1994	11/01/1994	0	26NOV94, platelets-5,000; same day (26NOV94) platelets-1,000; 30NOV94 platelets-38,000; during hospitalization, EBV, Cytomegalovirus, ANA, abdominal CT Scan & pelvic CT Scan tests-nl;Bone marrow study-early onset of megakaryocytes;	OTH	OTH	Vasotec (enalaprilmaleate);	NONE	hypertension; No known allergies;	NS~ ()~~~In patient	33654	1						1	Haemorrhage; Petechiae; Thrombocytopenia	FLU3~PARKE-DAVIS~~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0069583	12/14/1994	NC	54.0	54		M	12/08/1994	w/in 2 days p/shot sudden & immed drop in libido & sexual desire; difficulty maintaining erection; no problems prev to shot;								Y	N	10/31/1994	11/02/1994	2	NA	OTH	PVT	Vasotec; Paxil			~ ()~~~In patient		1						1	Erectile dysfunction; Libido decreased	FLU3~PFIZER\WYETH~4948110~1~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0069584	12/14/1994	MA	44.0	44		M	12/07/1994	had a bad sore throat w/swelling of lt side of face seen by MD given Augmentin;				Y					Y	11/05/1994	11/15/1994	10	throat culture nl; blood sugar high;	PUB	OTH	Zestril; Insulin	NONE	high blood pressure, diabetes	~ ()~~~In patient		1						1	Face oedema; Pharyngitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0069586	12/14/1994	MA	67.0	66		M	12/08/1994	chills, t102.2 fever, tired & weak 1 wk p/vax;				Y					Y	11/03/1994	11/09/1994	6		PUB	UNK		NONE		NONE~ ()~~~In patient		1						1	Asthenia; Chills; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0069588	12/14/1994	CT	42.0	42		F	12/05/1994	11PM 4NOV94 pt brushing teeth & passed out cold on the bathroom floor; periods of dizziness have occurred since then; pt undergoing a series of test & was seen by MD & neurologist;				Y					N	11/03/1994	11/04/1994	1	echocardiogram, EKG, EEG, mRI, Haltermonitor	UNK	UNK		NONE	NONE	~ ()~~~In patient		1						1	Dizziness; Syncope	FLU3~PFIZER\WYETH~4948128~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0069589	12/14/1994	CA	37.0	37		M	12/06/1994	arm swelled up, heat coming out of shot arm, redness, itchy;				Y					Y	12/06/1994	12/06/1994	0	HIV test	MIL	MIL	PPD	NONE	NONE	~ ()~~~In patient		1						1	Oedema peripheral; Pruritus; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0069594	12/14/1994	MA	28.0	28		F	11/28/1994	flu like sx occurred & lasted approx 24 hrs & then sx resolved;									Y	11/16/1994	11/16/1994	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~4F1059~1~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069595	12/14/1994	MA	39.0	39		F	11/28/1994	sore throat, cold sx, achy all over, h/a, post nasal drip;									Y	11/15/1994	11/18/1994	3	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Headache; Myalgia; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~4F1059~1~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069596	12/14/1994	MA	38.0	38		M	11/28/1994	started feeling lethargic approx 1 hr p/inject, funny fuzzy feeling, sore throat, runny nose & weakness in joints;									Y	11/15/1994	11/15/1994	0	NONE	PUB	PUB	NONE	runny nose	asthma	~ ()~~~In patient		1						1	Asthenia; Pharyngitis; Rhinitis; Somnolence	FLU3~CONNAUGHT LABORATORIES~4F1059~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069597	12/14/1994	MA	26.0	26		F	11/28/1994	17NOV94 stated coughing, nauseous, chest congestion, felt feverish;									Y	11/16/1994	11/17/1994	1	NONE	PUB	PUB		NONE		~ ()~~~In patient		1						1	Cough; Lung disorder; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F1059~1~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069598	12/14/1994	MA	22.0	22		F	11/28/1994	site of administration very sore; 16NOV94-arm is still very sore & now experiencing SOB, over all muscle soreness;									Y	11/15/1994	11/15/1994	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Dyspnoea; Injection site pain; Myalgia	FLU3~CONNAUGHT LABORATORIES~4F1059~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069599	12/14/1994	MA	45.0	45		M	11/28/1994	head felt like it would explode, upset stomach, diarrhea, achiness all over, very tired;									Y	11/16/1994	11/16/1994	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Diarrhoea; Dyspepsia; Headache; Myalgia	FLU3~CONNAUGHT LABORATORIES~4F1059~1~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069601	12/14/1994	MA	23.0	23		F	11/28/1994	hallucinations morbidly lethargic, diarrhea, vomiting-all day Thursday;									Y	11/16/1994	11/16/1994	0		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Diarrhoea; Hallucination; Somnolence; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F1059~1~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069602	12/14/1994	MA	81.0	81		F		340AM-620 10NOV 745AM & 815 loose stools; t99.6-malaise; 11NOV aching, t97.6; 12NOV weakness-stomach queasy; 13NOV improved-stomach better-no fever; 15NOV c/o stiffness in neck-warm packs w/relief-talked w/MD;									Y	11/09/1994	11/10/1994	1	NA	PUB	UNK	NONE	NONE		NONE~ ()~~~In patient		1						1	Asthenia; Diarrhoea; Malaise; Myalgia; Nausea; Nuchal rigidity; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069603	12/14/1994	MA	38.0	38		F	12/07/1994	throat opening appeared restricted, swallowing became difficult, chills, fever 100, achiness throughout body joints; next morning vision was blurred upon awakening (general flu-like sx for approx 48 hrs;)									Y	11/16/1994	11/16/1994	0	NONE	OTH	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Amblyopia; Arthralgia; Chills; Dysphagia; Influenza; Laryngospasm; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51059~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069244	12/15/1994	MA				F	12/12/1994	itching and swelling of hands and feet 5-6 hrs after vax.  Improved with benadryl.  Mild, persistant swelling when seen on following day.  Benadryl continued.  No residual sx after 2-3 days.									Y	11/21/1994	11/21/1994	0	none	OTH	UNK	none	none	none	~ ()~~~In patient		1						2	Dermatitis bullous; Oedema peripheral; Paraesthesia oral; Pruritus; Vasodilatation; Oedema peripheral; Pruritus	FLU3~CONNAUGHT LABORATORIES~4F51025~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0069615	12/15/1994	NV	72.0	72		M	11/16/1994	pt recvd vax;muscle started hurting in arm & shoulder,can raise arm half way,hurts when lowered & hand becomes numb feeling,trouble going to sleep at noc due to pain;told MD who referred to hlth district cause recvd vax there;									U	10/07/1994	10/09/1994	2		PUB	PUB	na;	na;	stomach tumor,going to surgery 18nov;	~ ()~~~In patient	NV94030	1						1	Hypokinesia; Insomnia; Myalgia; Pain; Paraesthesia; Hypokinesia; Insomnia; Myalgia; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4948119~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4948119~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0069615	12/15/1994	NV	72.0	72		M	12/11/1994	pt recvd vax;muscle hurting in arm;can raise arm halfway;has to lower arm very slowly;hurts when lowered,hand becomes numb feeling;trouble going to sleep due to pain;to MD who referred back to hlth dept;									U	10/07/1994	10/09/1994	2		PUB	UNK	na;		stomach cyst tumor, had surgery 18nov94;	~ ()~~~In patient		1						2	Hypokinesia; Insomnia; Myalgia; Pain; Paraesthesia; Hypokinesia; Insomnia; Myalgia; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4948119~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4948119~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0069616	12/15/1994	SD	42.0	42		F	11/15/1994	pt recvd vax;tingling,stiffness & soreness in neck & back all on lt side;pt called ofc then MD;was told sxs probably not from flu vax because sxs occured many days after vax;									U	11/09/1994	11/14/1994	5		UNK	PUB	none;	none;	diabetic;	~ ()~~~In patient	SD94039	1						1	Back pain; Hypertonia; Myalgia; Neck pain; Nuchal rigidity; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51024~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069619	12/15/1994	MA	44.0	44		F	12/06/1994	pt recvd vax;on 24nov,began to have burning itch over entire body;no hives/redness;some bumps;DPH & atarax for itch,lasted more than 1 wk;5dec94 sore throat w/ sinusitus, nasal congestion began 1 wk prior to sinusitus;				Y						11/21/1994	11/24/1994	3		PVT	UNK			environmental allergies (dust,cats,down,pollen, etc);	~ ()~~~In patient		1						1	Pain; Pharyngitis; Pruritus; Rash; Rhinitis; Sinusitis	FLU3~CONNAUGHT LABORATORIES~4F51059~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069620	12/15/1994	MA	37.0	37		F	12/09/1994	pt recvd vax;on 1dec94 started feeling lethargic, on 4dec94 v x 2; ha, very lethargic, achy joints; 9dec94 feeling better;									Y	11/18/1994	12/01/1994	13	none;	PUB	UNK	none;	none;	none;	~ ()~~~In patient		1						1	Arthralgia; Headache; Somnolence; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F1059~1~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069621	12/15/1994	MA	66.0	66		F	12/11/1994	pt recvd vax;sore throat on 11nov;apap & flu pills given till 14nov;start n 15nov; sore lt shoulder & arm 13nov;11dec swollen lt wrist & dec tendon,cannot lift or hold a cup;no appetite strength;recovering 9dec94;									Y	11/10/1994	11/15/1994	5		PUB	OTH	synthroid	none;	rxn to flu shot in 60's;none until 94;	in pt, rxn to flu shot at 30 yrs old;~ ()~~~In patient		1						1	Anorexia; Asthenia; Hypokinesia; Myalgia; Nausea; Osteoarthritis; Pharyngitis; Tendon disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069622	12/15/1994	MA	65.0	65		U		pt recvd vax; sore throat, achy bones;cont cough;early pneumonia, infected sinuses(both sides);seen MD; tx w/ guiatuss AC hydrocodone syrup,ceftin,biaxia,rhinocort nasal inhaler;chest x-ray,sinus x-ray;									N	11/05/1994	11/06/1994	1		PUB	UNK		none;	none;	~ ()~~~In patient		1						1	Bone pain; Cough; Pharyngitis; Pneumonia; Sinusitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069624	12/15/1994	MA	21.0	21		F	12/09/1994	pt recvd vax;approx 10 mins later, felt dizzy for 1/2 hr; swelling at site; pain in upper shoulder & back; problems resolved 17nov94;									Y	11/16/1994	11/16/1994	0	none;	PUB	PUB	none;	none;	none;	~ ()~~~In patient		1						1	Back pain; Dizziness; Injection site oedema; Pain	FLU3~CONNAUGHT LABORATORIES~4F1059~1~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069625	12/15/1994	MA	25.0	25		F	12/09/1994	pt recvd vax; devel low grade fever, sweating, flu like sxs;									Y	11/16/1994			none;	PVT	PUB	none;	none;	none;	~ ()~~~In patient		1						1	Hyperhidrosis; Influenza; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F1059~1~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069628	12/15/1994	WA	68.0	68		F	01/11/1994	swelling in lt hand lasting several months, edema in arm, no treatment, under observation									U	10/27/1993	11/04/1993	8	none	PVT	OTH	hctz occasionally prior to injection, now on daily basis	none	fx upper humerus & rotator cuff separation, 1.3 cm malignant breast lump	none~ ()~~~In patient		1						1	Oedema peripheral	FLUX~PFIZER\WYETH~4938163~UNK~L~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069634	12/16/1994	OH	64.0	64		M	11/14/1994	pt recvd vax;on 18oct has diffuse rash & fever;21oct adm to hosp w/ fever & pancytopenia(WBC=0, platelets 60,000);bone marrow biopsies;rx'd w/ ATBs; recovered;					Y	10			Y	10/12/1994	10/18/1994	6	bone marrow biopsies (24oct94,7nov94); CBC (nl as of 17nov94); no viral cultures were done;	PVT	PVT	on antihypersensives for several years;		mild chronic renal failure from hypertension; h/o agranulocytosis (WBC decreased to 1000; no PMNs); resolved p/treatment w/steroids p/4-6 weeks; no blood transfusion;no documented viral infect;	unk;~ ()~~~In patient	940240001	1						1	Leukopenia; Pancytopenia; Pyrexia; Rash; Thrombocytopenia	FLU3~PFIZER\WYETH~4948118~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~384959~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0069639	12/16/1994	OH	32.0	32		F	11/29/1994	pt recvd vax 3:15pm; approx 5pm started w/ bad ha;at 6:30pm had difficulty swallowing,breathing,throat swelling;called family MD;to er;recvd IV,steroids & DPH;				Y					Y	11/16/1994	11/16/1994	0		PUB	PUB	none;	none;	none;	~ ()~~~In patient	OH94125	1						1	Dysphagia; Dyspnoea; Headache; Laryngospasm	FLU3~CONNAUGHT LABORATORIES~4F51055~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069641	12/16/1994	MD	49.0	49		M	11/27/1994	pt recvd vax;noticed decline in ability beginning w/ period p/ flu shot;petechia on legs,large bruises,cont nasal blood seepage;ITP dx mar94;5 hospitalizations w/ steroids gamma immune,decadrone P tx;platelet count responsive to decadrone;			Y		Y	30		Y		11/02/1993	01/06/1994	65	weekly platelets antibody testing;dx chronic idiopathyl thrombocytopenia purpura;	OTH	PUB	sudafed, advil, valium;	none;	allergies to milk,foods;tx w/ shots 10 years previously;	in pt, allergy to pcn;~ ()~~~In patient		1						1	Ecchymosis; Epistaxis; Petechiae; Thrombocytopenic purpura	FLU3~CONNAUGHT LABORATORIES~3J41019~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0069644	12/16/1994	WA	41.0	41		F	12/01/1994	pt recvd vax; devel redness, swelling, itching & soreness;				Y					Y	11/07/1994	11/07/1994	0		OTH	OTH	claritin;	none;	not allergic to meds or egg products;	none;~ ()~~~In patient		1						1	Myalgia; Oedema; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~494842~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0069651	12/16/1994	VT	56.0	56		M	12/02/1994	pt recvd vax in pm;noc,began feeling bad & by next am was sick,t 97.7;agitation & fatigue,called erethism;inc in sinus/nasal allergy sxs;allergic rxn to thimerosal;pt allergic to mercury & flu vax contained mercury preservatives;									Y	11/14/1994	11/14/1994	0		PVT	PVT	none;		allergic to mercury, since early 1980's;	in pt,same event occured last yr,pt thought it was flu vax;lasted 1 day;~ ()~~~In patient		1						1	Agitation; Asthenia; Central nervous system stimulation; Condition aggravated; Hypersensitivity; Hypothermia; Malaise	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0069652	12/16/1994	MN	67.0	67		M	12/12/1994	pt recvd vax;2 hrs later had fever, chills & d x 1 day;d has cont through 12dec94;pt instructed to use imodium & use the BRAT diet; f/u PRN;									U	12/07/1994	12/07/1994	0	na;	PVT	PVT	depotestosterone; calan;	none;	klinefelters synd, hypertension, venous stasis;	na;~ ()~~~In patient		1						1	Chills; Diarrhoea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51102~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069655	12/16/1994	NY	38.0	38		M	11/25/1994	pt recvd vax; arm swelling from inj site to elbow & down under arm;no rash, no fever or chills noted;									Y	11/16/1994	11/17/1994	1	none;	PVT	PVT	proventil;tilede;flexeril;motrin;tigamet;serox;cleniter;aerobid;	none;	none;	~ ()~~~In patient		1						1	Injection site oedema	FLU3~CONNAUGHT LABORATORIES~4F51088~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~380956~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0069656	12/16/1994	WA	42.0	42		U		pt recvd vax;awoke w/ swollen rt eyelid & numb swollen lt upper lip;called er x 2 for info;21nov,awoke w/lt swollen eyelid & soreness;saw MD;20nov rash around neck;at least 3 hive episodes;8:30am hives(rash)all over;dph taken,hives abated;				Y						11/17/1994	11/20/1994	3	urine analysis  neg results;	OTH	UNK	zoloft;aspirin;atenolol;	none x/ stress;		~ ()~~~In patient		1						1	Face oedema; Myalgia; Paraesthesia; Rash; Urticaria	FLU3~PFIZER\WYETH~4948104~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0069657	12/19/1994	CA	75.0			F	11/30/1994	pt recvd flu vax 23NOV94 & the next day began to exp unspecified gastrointestinal sx; 27NOV94 pt began to exp numbness in both legs followed by paralysis; adm to hosp dx tranverse spinal myelitis; pt remains hospitalized as of the date;					Y				N	11/23/1994	11/24/1994	1		OTH	OTH	unk	none	none	~ ()~~~In patient	894342007S	1						1	Blood creatine phosphokinase increased; Gastrointestinal disorder; Myelitis; Paraesthesia; Paralysis	FLU3~PFIZER\WYETH~4948120~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0069658	12/19/1994	AL				M	11/28/1994	pt recvd 17NOV92 & pt exp a hypersensitivity react permanent injury to immune system,  disorder in immune system, rheumatoid like condition, inflammatory condition; devel GBS assoc w/partial paralysis, polyneuropathy, numbness, facial weak				Y	Y			Y	N	11/17/1992			LP-results unspecified;	PVT	OTH	unk	unk	pt has a hx of hypertension & coronary artery disease;	NONE~ ()~~~In patient	894342006S	1						1	Condition aggravated; Depression; Guillain-Barre syndrome; Hypersensitivity; Immune system disorder; Neuropathy; Paraesthesia; Paralysis	FLU3~PFIZER\WYETH~4928235~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0069662	12/19/1994	NY	77.0	77		F	12/02/1994	index devel rash on l/a & arm turned black & blue & yellow a wk later; index states that as of 2DEC94 arm still yellow;									Y	11/21/1994	11/24/1994	3	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	BAM031	1						1	Rash; Skin discolouration	FLU3~CONNAUGHT LABORATORIES~4F51060~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0145A~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0069664	12/19/1994	MA	71.0	71		F	11/21/1994	rt arm swelled up-site was tender & warm seen by MD-treated w/ATB for cellulitis;				Y					Y	11/09/1994	11/09/1994	0		PUB	OTH		NONE	diabetes, Insulin	~ ()~~~In patient	MA9440	1						1	Cellulitis; Injection site pain; Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51025~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0536A~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0069665	12/19/1994	MA	44.0	43		F	11/28/1994	2 wks post inject devel swelling all over body s/b MD-tested for lupus neg, decided to be virus				Y					Y	10/26/1994	11/23/1994	28		PUB	UNK	Mycline	NONE	unk	~ ()~~~In patient	MA9441	1						1	Generalised oedema; Infection	FLU3~CONNAUGHT LABORATORIES~4F51015~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069667	12/19/1994	MA	89.0	89		F	11/29/1994	site of vax inject rt deltoid muscle became erythematous condition lasted approx 24 hrs-resolved & undetectable afterwards;									Y	11/03/1994	11/03/1994	0	NA	PUB	PUB				NA~ ()~~~In patient	MA9443	1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~4F51025~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069668	12/19/1994	MA	79.0	79		F	12/07/1994	chills, fever 102, nausea;									Y	11/09/1994	11/09/1994	0		PUB	OTH	ASA, Micronase, Prevocol		DTP sensitivity (pertussis) diabetes	~ ()~~~In patient	MA9444	1						1	Chills; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51025~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069669	12/19/1994	MA	68.0	68		F	11/28/1994	tightness in throat & chest; h/a; joint pain;									Y	11/14/1994	11/14/1994	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MA9445	1						1	Arthralgia; Chest pain; Headache; Laryngospasm	FLU3~CONNAUGHT LABORATORIES~4F51025~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069670	12/19/1994	MA	42.0	42		F	12/01/1994	approx 2 days following vax pt exp upper resp sx, bad gastrointestinal problems a few hrs prior to having tonic clonic sz while asleep; also has had partial sz episodes;				Y	Y	1			Y	11/10/1994	11/15/1994	5	EEG; MRI;	OTH	OTH			had prior sz episode x 5 yrs ago unrelated to vax;	~ ()~~~In patient	MA9446	1						1	Condition aggravated; Convulsion; Gastrointestinal disorder; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~4F51165~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0069676	12/19/1994	VA	69.0	69		F	12/02/1994	sx occurred 3 hrs p/inject throat felt raw; tongue, mouth, lips swollen, eyes bulging, difficulty breathing, anxiety;				Y					Y	11/28/1994	11/28/1994	0	NONE	PUB	UNK	NONE	NONE	allergic to shell fish	~ ()~~~In patient	VA94085	1						1	Anxiety; Dyspnoea; Face oedema; Pharyngitis; Tongue oedema	FLU3~CONNAUGHT LABORATORIES~4F51158~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069678	12/19/1994	VI	30.0	30		M	11/28/1994	pt recvd vax 18NOV94 & exp generalized weakness 48 hrs later w/fever 102.6, general malaise; dx post flu vax react-hospitalized 24NOV94 w/nausea & vomiting; hx known diabetic, hypertension controlled w/diet; 1DEC94 transferred to hosp;			Y		Y		Y		N	11/18/1994	11/20/1994	2	28NOV94 WBC 800;	PUB	PUB	NONE	NONE	diabetes-hypertension (mild)	NONE~ ()~~~In patient		1						1	Asthenia; Malaise; Nausea; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51133~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0069681	12/19/1994	CA	55.0	55		M	12/15/1994	GBS onset 31OCT94 hospitalized;					Y	48			U	10/23/1994	10/31/1994	8	unk	OTH	PVT	UNK	NA	NA	~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLU3~MEDEVA PHARMA, LTD.~E2534HA~UNK~IM A~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0069682	12/19/1994	MA	60.0	60		F	12/08/1994	double pneumonia hospitalized 16NOV94 to date;				Y	Y	23			N	11/07/1994	11/09/1994	2		OTH	OTH		NONE	NONE	~ ()~~~In patient		1						1	Pneumonia	FLU3~CONNAUGHT LABORATORIES~4F51059~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0069684	12/19/1994	PA	73.0	73		M	12/09/1994	acute CVA, lt hemiparesis; dysphagia post; pt had flu vax 12OCT94; CVA-30OCT94; pt has hx of CVA w/ rt hemiparesis on 13OCT93; 2 wkd prior to CVA in 1993 pt had a flu shot;			Y		Y	14		Y	N	10/12/1994	10/30/1994	18	MRI: multifocal ischaemic disease involving matter basal ganglia;	PVT	PVT	Micconas; Procardia	HBP type II Dm (old, no new disease)	HBP-CVA rt hemiparesis; type II DM	pt exp rt hemiparesis @A 72 y/o flu shot;~ ()~~~In patient		1						1	Cerebral infarction; Cerebrovascular accident; Dysphagia; Hemiplegia; Laboratory test abnormal	FLU3~PARKE-DAVIS~00374P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0069688	12/19/1994	OH	72.0	72		F	11/27/1994	pt recvd vax & 1-2 hrs p/vax called clinic c/o single itching welt; back of neck 245 felt many more welts mid har to shoulders, no swelling throat, breathing difficulty-husband present-advised immed medical attention;				Y					Y	11/04/1994	11/04/1994	0		PUB	PUB		No acute	arthritis	Patient unsure~ ()~~~In patient		1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51088~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069690	12/19/1994	IL	72.0	72		M	12/10/1994	lt arm pain-intense local react gross edema redness-warm & tender to touch; limited use secondary to pain;				Y					Y	10/05/1994	10/05/1994	0	NONE	PVT	PVT	Xanax, Norvas, Mevacas; Ispor, Lasix, Dalmane		allergies Iodine; dx ASCUP, CAD, Angina, CHF	NA~ ()~~~In patient		1						1	Hypokinesia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pain; Vasodilatation	FLU3~PARKE-DAVIS~01564P~6~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~0536A~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0069694	12/19/1994	GA	32.0	31		F	12/16/1994	itching, hives, swelling of eyes & lips; treated w/Atarax;				Y					Y	12/15/1994	12/15/1994	0	NA	MIL	MIL	NA	NONE	NONE	NONE~ ()~~~In patient		1						1	Face oedema; Pruritus; Urticaria	FLU3~PFIZER\WYETH~~7+~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0069704	12/19/1994	CA	45.0	45		F	12/12/1994	pt recvd vax & exp allergic react rt arm-FU; pt states slept a lot; some warmth; pt noticed some redness around rt elbow w/swelling & ince warmth; exp some abdo pain & chills; bowel movements watery x 6; poss cellulitis vx urticarial;									Y	10/18/1994	10/20/1994	2		OTH	UNK	Dipenlenx		ulcerative colitis	~ ()~~~In patient		1						1	Abdominal pain; Cellulitis; Diarrhoea; Hypersensitivity; Oedema peripheral; Rash; Somnolence; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069721	12/20/1994	NH	74.0	74		M	10/27/1994	12 hrs p/shot complete shaking, severe flexion spasm-t102, nausea, perspiration; went beyond severe shaking as result of chills; 2AM temp nl-presently has severe h/a, generalized aching-backache-fatigue;									Y	10/26/1994	10/26/1994	0		PUB	PUB			severe environmental allergies-african wood dust; allergic bronchitis	~ ()~~~In patient	NH94039	1						1	Asthenia; Back pain; Headache; Hyperhidrosis; Hypertonia; Myalgia; Pyrexia; Tremor	FLU3~CONNAUGHT LABORATORIES~4F51016~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069722	12/20/1994	NH	36.0	36		F	12/12/1994	numbness & weakness all 4 limbs; GBS;				Y	Y	10			N	11/09/1994	11/21/1994	12	spinal fluid; Bloodwork;	PUB	PUB	Clomid	NONE	NKA	NONE~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51055~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0069723	12/20/1994	MD				M		pt recvd vax & was adm to hosp w/purpura; hx reveals bleeding gums starting 4NOV, easy bruising & diarrhea w/blood noted 5NOV; spots noted on tongue 7NOV & nodule; final dx thrombocytopenic purpura; also exp swelling of proximal phalanx					Y					10/27/1994	11/07/1994	11	Blood test drawn in AUG93 showed a GGTP 114, SGOT & SGPT nl; uric acid 8.8, sugar 135, triglycerides 197, cholesterol 216 w/HDL 38; WBC was 4900 w/74 segs, 12 lymphs, 9 monos, & 5 eos; platelte count 88,000; PT & PTT nl;	UNK	UNK	ASA, Lomitil, Tolaziamide	calf aches	diabetes	~ ()~~~In patient		1						1	Anaemia; Diarrhoea haemorrhagic; Leukopenia; Lung disorder; Petechiae; Purpura; Skin nodule; Thrombocytopenic purpura	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0069725	12/20/1994	WA	79.0	78		F	12/16/1994	pt recvd vax 18NOV94 & 21NOV pt c/o weakness, SOB, difficulty swallow; seen in ER w/numbness, neuralgia-c/o stumbling & falling; 30NOV progressive weakness, GBS; 1DEC intubation;				Y	Y	21	Y		U	11/18/1994	11/21/1994	3		MIL	OTH	Verapamil; Digoxin; Valium	NONE	hx GB JUL93, hx PSVT, hx chronic anxiety; hx neuragenic bladder	~ ()~~~In patient		1						1	Asthenia; Dysphagia; Dyspnoea; Gait disturbance; Guillain-Barre syndrome; Neuropathy; Paraesthesia; Respiratory disorder; Asthenia; CSF test abnormal; Dysphagia; Dyspnoea; Guillain-Barre syndrome; Neuropathy; Paraesthesia; Respiratory disorder	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0069726	12/20/1994	MA	68.0	68		M	12/02/1994	5 days later had a severe cold, bad cough, fever p/which 10 dasy had to go to MD for ATB & cough syrup;				Y						11/09/1994	11/14/1994	5		PUB	PUB	Lotensin	NONE	NONE	~ ()~~~In patient		1						1	Cough; Pharyngitis; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0069727	12/20/1994		0.08	0	.1	M	12/12/1994	red rash occurred 4 hrs p/vax;									Y	12/07/1994	12/07/1994	0	NONE	UNK	UNK	NONE	NONE	PCN-rash			1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~1~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069733	12/22/1994	OH	0.5	0	.5	M	12/16/1994	found not breathing by grandmother; taken to ER & revived; airlifted to hosp expired 12DEC94;	Y	12/12/1994		Y	Y				N	12/12/1994	12/12/1994	0		PVT	PVT	Lasix, Digoxin, Ferinsol	rt hypoplastic ventricle	congenital heart defect; scheduled for surgery in JAN95		CO5748	1						1	Apnoea	DTP~CONNAUGHT LABORATORIES~4L51146~UNK~~~DTP (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~4F51023~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~CONNAUGHT LABORATORIES~4B61023~3~IM~~HIB (ACTHIB)~1|OPV~PFIZER\WYETH~~3~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~1	USA	Results in Death	Influenza
0069734	12/22/1994	MA	54.0	54		F		acute epiglotitis cellulitis; severe sore throat & neck swollen & red; to ER on 15NOV94 discharged to home 18NOV94;			Y	Y	Y	4			Y	11/02/1994	11/14/1994	12	causative organism not identified;	PUB	PUB				~ ()~~~In patient	MA9447	1						1	Cellulitis; Dry mouth; Infection; Oedema; Pharyngitis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51025~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0069737	12/22/1994	TN	71.0	71		M	12/06/1994	pt claims devel tender reddened area rt deltoid (just 2 days p/receiving vax in the same site); denies fever, but c/o persistent pain in extremity;				Y					U	10/20/1994	10/22/1994	2	reveals tender  nodule on rt deltoid; dec ROM	PUB	PUB	Motrin, ASA, Cimetidine, Isosorbide, Ducosate, sodium, Beciomethasone nasal	NONE	coronary bypass x 4; kidnwy surgery x8; lung surgery	~ ()~~~In patient	TN94161	1						1	Hypokinesia; Injection site hypersensitivity; Injection site mass; Injection site pain; Pain	FLU3~PFIZER\WYETH~4948116~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0069742	12/22/1994	CA	40.0	40		F	11/22/1994	pt recvd vax;sxs started eve of vax;lt arm where pneumonia shot given,red,warm,swollen;sx got worse & to MD;rx keflex x 2 days;arm infect at inject; dx per MD; lt arm swollen above & below elbow;2nd PMD visit 18noov94;arm better;				Y					Y	11/09/1994	11/09/1994	0	none;	PUB	PUB	none;	sinus infect 2 days a/ flu shot;		none;~ ()~~~In patient		1						1	Infection; Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51008~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0145A~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0069745	12/22/1994	CA	56.0	56		F	11/22/1994	pt recvd vax; sx started next am; awoke w/ fever, chills,malaise, body aches; fell asleep; slept for 3 days; arm was hot, achy, full of melts;									Y	11/16/1994	11/17/1994	1	none;	UNK	UNK		none;	none;	none;~ ()~~~In patient		1						1	Chills; Malaise; Myalgia; Pyrexia; Somnolence; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51008~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0145A~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0069824	12/23/1994	WA	19.0	19		M	12/07/1994	pt developed reaction described as cellulitis.  PT still reports limited range of motion in injection arm and states that it locks up.  Continuing pain and swelling below elbow, PT may require readmission to hospital.					Y	2			N	12/02/1994	12/03/1994	1		MIL	MIL	unk	UNKNOWN	PT RECEIVED A TYPHOID DOSE 6 WEEKS PRIOR TO PRESENT INJECTION WITHOUT ADVERSE REACTIONS	~ ()~~~In patient	894348002S	1						1	Cellulitis; Hypokinesia; Oedema peripheral; Pain; Oedema peripheral	FLU3~PFIZER\WYETH~4948203~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TYP~PFIZER\WYETH~4938265~2~IM A~~TYPHOID VI POLYSACCHARIDE (ACETONE INACTIVATED DRIED)~1|TYP~PFIZER\WYETH~4938265~2~IM A~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0069828	12/23/1994	UT	54.0	54		F	12/13/1994	THROAT SWELLED AND PT HAD DIFFICULTY BREATHING, EYES BECAME SWOLLEN & EXTREME H/A OCCURRED, PT NAUSEATED. 12/13/94 PT HAD HA & SLIGHTLY SWOLLEN EYES BUT OTHERWISE BETTER. PT TOOK 2 SUDAFED 7 HRS AFTER VAX AND FELT RELIEF W/ IN 30 MIN.									Y	12/12/1994	12/12/1994	0	none	PUB	UNK	NONE	NONE	ALLERGIC TO DEMEROL	~ ()~~~In patient	UT941826	1						1	Dyspnoea; Face oedema; Headache; Laryngospasm; Nausea	FLU3~CONNAUGHT LABORATORIES~4F51071~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0068382	12/27/1994	NY	85.0	85		F	10/24/1994	pt recvd vax; pt already in poor condition; 18oct t of 100; BP 110/54,scattered fine crakles thru out both lung fields; cont w/ same sxs until death 19oct94;	Y	10/19/1994							N	10/17/1994	10/18/1994	1		UNK	UNK			in poor condition;	~ ()~~~In patient	NY94064	1						2	Anorexia; Asthenia; Condition aggravated; Dyspnoea; Lung disorder; Malaise; Somnolence; Stupor; Lung disorder; Pyrexia	FLU3~PARKE-DAVIS~00474P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00474P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Results in Death	Influenza
0068383	12/27/1994	NY	88.0	88		F	10/24/1994	pt recvd vax;pt was deteriorating prior to vax; condition cont to deteriorate;no inc or obvious change; no t; lungs clear; BP 92/50; 17oct 70/40; 20oct, LOC; expired at 12pm;	Y	10/20/1994							N	10/17/1994				OTH	OTH			was deteriorating prior to vax;	~ ()~~~In patient	NY94062	1						2	Apnoea; Cardiac arrest; Condition aggravated; Hypotension; Hypotension; Syncope	FLU3~PARKE-DAVIS~00474P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00474P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Results in Death	Influenza
0068384	12/27/1994	NY	69.0	69		F	10/24/1994	pt recvd vax;progressive neuropathy;S/P rt hip fx 17sep; condition poor; 17oct94 122/68,lungs clear; 18oct 2pm lungs full fld & congestion thru out; no t; maintained crakles thru out for 24 hrs;	Y	10/21/1994							N	10/17/1994	10/18/1994	1	chest x-ray neg;	OTH	UNK			progressive neuropathy,s/p rt hip fx 17sep;condition poor;	~ ()~~~In patient	NY94063	1						2	Cardiovascular disorder; Condition aggravated; Lung disorder; Lung disorder; Rhinitis	FLU3~PARKE-DAVIS~00474P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00474P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Results in Death	Influenza
0069262	12/27/1994	MD	49.0	49		F	12/01/1994	pt recvd vax;ha & fever on & off x 5 days p/ flu vax;devel encephalitis;adm to hosp x 3 days;given IV steroids the PO steroids; sxs better;					Y	3			Y	09/23/1994	09/28/1994	5		PVT	PVT		none;	none;	~ ()~~~In patient		1						2	Arthralgia; Encephalitis; Headache; Pyrexia; Thinking abnormal; Encephalitis; Headache; Pyrexia	FLU3~PFIZER\WYETH~4948125~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4948125~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0069725	12/27/1994	WA	79.0	78		F	12/09/1994	pt recvd vax;had hx of GBS;3 days p/vax,devel shortness of breath,weakness in walking,general fatigue;25nov,devel general numbness,neuropathy;adm to hosp,dx GBS;intubated 1dec94,on plasmapherisis tx;remains on ventilator as of this date;					Y				U	11/18/1994	11/21/1994	3	LP protein 143; LP glucose 108; LP WBC none; LP RBC 2;	PVT	PVT	valium, digoxin; verapamil; acetaminophen;		hx of GBS JUL93 p/viral illness; dx based on physical exam, CSF findings & EMG; hx: PSVT since age 14, GI bleed AUG93, diverticulosis, pseudogout, chronic anxiety, & anorexia w/poor nutritional status; recvd flu vax last year w/no problems;	~ ()~~~In patient	894346001S	1						2	Asthenia; Dysphagia; Dyspnoea; Gait disturbance; Guillain-Barre syndrome; Neuropathy; Paraesthesia; Respiratory disorder; Asthenia; CSF test abnormal; Dysphagia; Dyspnoea; Guillain-Barre syndrome; Neuropathy; Paraesthesia; Respiratory disorder	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0069841	12/27/1994	GA	68.0	67		F		pt recvd vax; devel GBS; had sepsis on adm to hosp; may be unrelated;								Y	N	10/13/1994	11/20/1994	38	na;	PVT	PVT		none;	sepsis at onset of sxs 4-5 wks p/ inject;	~ ()~~~In patient	PA9508	1						1	Nephritis; Sepsis	FLU3~PFIZER\WYETH~4948076~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0069843	12/27/1994	MA	80.0	79		F	11/22/1994	pt recvd vax;c/o bilateral lower back pain x 2 mo;pale & dyspneic;loss of appetite x 2 wks;weight loss;tests revealed inc bilirubin 2.6,HGB dec 8.1;HCT dec 23.5;platelets dec 13,000,ESR inc 55;WBC WNL 7.9;was hospitalized;			Y	Y	Y	15	Y		Y	10/08/1994	11/01/1994	24	platelet count 10,000; hematocrit 22; reeculolute count 22%; direct coombs test pos;	OTH	PUB	none;	none;	lumbar disc disease,bilateral cataracts,obesity,psoriasis;	~ ()~~~In patient		1						1	Anaemia; Coombs direct test positive; Dyspnoea; Hyperbilirubinaemia; Hypochromic anaemia; Pallor; Red blood cell sedimentation rate increased; Thrombocytopenia	FLU3~CONNAUGHT LABORATORIES~4F51011~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0069850	12/27/1994	NJ	55.0	55		F	12/20/1994	pt recvd vax;day p/ vax,became weak & sluggish;about 1 1/2 wk p/vax,lost hearing rt ear accompanied by pain;now main problem is hearing loss of rt ear;				Y				Y	N	11/10/1994	11/11/1994	1	none;	OTH	OTH	none;		pcn, ASA;	~ ()~~~In patient		1						1	Asthenia; Deafness; Ear pain; Hypokinesia	FLU3~CONNAUGHT LABORATORIES~4F51145~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0069851	12/27/1994	OH	62.0	62		F	12/12/1994	pt recvd vax; weakness affecting both upper & lower extremities, compatible w/ GBS;					Y				N	11/11/1994	11/12/1994	1	CSF	PVT	PVT	pub	none;	none;	~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~4F51016~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0069853	12/27/1994	MA	71.0	71		F	12/11/1994	pt recvd vax;body aches for 2-3 wks (moving around esp in back); inc t then terrible sore throat x 1 wk then 1 wk of laryngitis & complete deafness;				Y				Y	Y	11/01/1994	11/02/1994	1		OTH	UNK	ferrous sulfate;	none;	mild anemia;	none;~ ()~~~In patient		1						1	Back pain; Deafness; Laryngitis; Myalgia; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51088~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0069855	12/27/1994	ME	47.0	47		F	12/19/1994	pt recvd vax;9:15am,pt reported itching & swelling at inject site;ice pack applied & dph given;2pm to hosp er; SOB; tx w/ epi,monitered & released;				Y					Y	10/20/1994	10/20/1994	0		PUB	PVT	premarin;	none;	none;	na;~ ()~~~In patient		1						1	Dyspnoea; Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~CONNAUGHT LABORATORIES~4F51016~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069856	12/27/1994	LA	1.0	1	.0	M	12/21/1994	pt recvd vax; devel generalized tonic clonic sz; fever;				Y	Y	4			Y	12/12/1994	12/14/1994	2		PVT	PVT		none;	allergic rhinitis;	~ ()~~~In patient		1						1	Convulsion; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51113~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0069857	12/27/1994	CA	70.0	69		F	12/15/1994	pt recvd vax;shortly p/ vax,devel redness & itchy swelling; 2cm, persisted x 2  wks w/ persistent vascular ectasia;				Y					Y	11/09/1994				PVT	UNK		none;	spider bite rxn 1 w; a/ lt hand;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0069865	12/27/1994	WY	7.0	7		F	12/19/1994	pt recvd vax;devel fever,ha,general aches & pain, rash, eve of vax;rash across back & very itchy;recommended that mom contacted fam MD;no more inject w/out MD's order because of rash;no resp difficulties;									Y	11/09/1994	11/11/1994	2	na;	PUB	PUB	none;	none;	pcn shots;	~ ()~~~In patient		1						1	Headache; Myalgia; Pain; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~4F51072~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069870	12/27/1994	NY	55.0	55		F	11/10/1994	pt recvd vax;right p/ vax devel paresthesis & numbness in hand which was later dx as mononeuropathy;									Y	10/21/1994	10/21/1994	0		PVT	OTH		none;	none;	~ ()~~~In patient		1						1	Neuropathy; Paraesthesia	FLU3~PFIZER\WYETH~4948052~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0069879	12/27/1994	ME	57.0	57		F	12/19/1994	pt recvd vax; 9:10am, itching & swelling at inject site; ice applied; dph given; pt monitered until 10:30am;									Y	10/20/1994	10/20/1994	0	none;	PUB	PVT	premarin;	none;	none;	na;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~CONNAUGHT LABORATORIES~4F51026~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069885	12/27/1994	AK	42.0	42		F	12/05/1994	pt recvd vax;rash/welts,inner arms & neck; persistent dry cough;chest tightness;felt light sensitivity,blurring vision, sleepy;no appetite;to PMD 30nov;states had flu-like sxs,but feels alright now;									Y	11/28/1994	11/28/1994	0	none;	OTH	OTH	paxil;	none;		~ ()~~~In patient		1						1	Amblyopia; Anorexia; Chest pain; Cough; Influenza; Photosensitivity reaction; Rash; Somnolence	FLU3~PFIZER\WYETH~4948197~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0069888	12/27/1994	VA	43.0	43		F	12/20/1994	pt recvd vax; devel hives, cough, chest tightness, throat closing feeling 45 mins p/ shot; lasted 2 hrs w/ dph;									Y	11/09/1994	11/09/1994	0		MIL	OTH	prozac;	none;	hx of bronchial asthma; smoker; depression;	~ ()~~~In patient		1						1	Chest pain; Cough; Laryngospasm; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069892	12/27/1994	OH	81.0	81		F	10/27/1994	pt recvd vax; inc t 98.8; t 99.4 on 14oct, afebrile 98.5 16oct; c/o ha;									Y	10/04/1994	10/07/1994	3		OTH	OTH	cardizem,advil,ma oxid,tomoxifen,zoloft,Iberts,fibercon,colace,levothroid;	decubitus @ coccyx	demerol;	in pt, inc t w/ 1st flu vax;~ ()~~~In patient		1						1	Headache; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51134~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069894	12/27/1994	AZ	50.0	49		F	12/16/1994	pt recvd vax; c/o feeling shakey;exp shivers & frog in throat about 5pm;by 10pm pt became short of breath,felt like heavy weight on chest;upon awakening next am,felt fine & had no complaints;									Y	11/04/1994	11/04/1994	0	none;	PUB	PUB	denies;	denies	denies	denies~ ()~~~In patient	AZ9437	1						1	Chest pain; Chills; Dyspnoea; Pharyngitis; Tremor	FLU3~CONNAUGHT LABORATORIES~4F51008~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069898	12/27/1994	ID	66.0	66		F	11/01/1994	pt recvd vax;20-25 mins later exp weakness & wobbly legs,mouth dry,difficulty swallowing, feeling of going to faint;P raced & head became fuzzy;lasted about 3-3 1/2 hrs;pt did not feel nl until 29oct94 in the am;										10/28/1994	10/28/1994	0		PUB	PUB	premarin;	none;	none;	~ ()~~~In patient	ID94076	1						1	Asthenia; Dizziness; Dry mouth; Dysphagia; Tachycardia	FLU3~CONNAUGHT LABORATORIES~4F51024~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069899	12/27/1994	ID	40.0	40		F	11/16/1994	pt recvd vax;approx 30-45 mins later,itchy throat & dry cough for about 4 hrs;3 hrs later eyes became irritated & had yellowish discharge;in eve ached all over as if tons of bricks hit her;in bed x 48 hrs;p/ 24 more hrs felt better;									Y	10/24/1994	10/24/1994	0	none;	PUB	PUB	none;	none;	none;	~ ()~~~In patient	ID94077	1						1	Conjunctivitis; Cough; Myalgia; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~4F51024~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069900	12/27/1994	ID	41.0	41		M	11/15/1994	pt recvd vax;27oct in eve,exp difficulty in breathing & eyes became blood shot;28oct devel ha,sore throat,nasal congest,watery eyes;29oct exp flu-like sxs;stayed in bed;30oct fever,chills;31oct cont to feel sick;1nov94 better;									Y	10/27/1994	10/27/1994	0		PUB	PUB	ASA;	none;	none;	~ ()~~~In patient	ID94078	1						1	Conjunctivitis; Dyspnoea; Headache; Influenza; Lacrimal disorder; Malaise; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~4F51067~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069901	12/27/1994	ID	55.0	54		F	11/16/1994	pt recvd vax;11:45 felt light headed; 3:30 difficulty breathing,tightness in throat;general body aches;5 became n; ha & v for 3 hrs;next day had ha, felt weak but improved;									Y	11/01/1994	11/01/1994	0	none	PUB	PUB	none	none	none	~ ()~~~In patient	ID94079	1						1	Asthenia; Dizziness; Dyspnoea; Headache; Laryngospasm; Myalgia; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51067~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069902	12/27/1994	ID	39.0	39		F	11/16/1994	pt recvd vax;12:30 felt difficulty breathing;3:30 devel inc t;ha; eye became blood shot;swollen glands/throat area & very lethargic;6:30 n,8:30 abdo cramping;lethargy,ha persisted thru noc;next day tired,ha but improved;									Y	11/01/1994	11/01/1994	0	none;	PUB	PUB	none	none	none;	~ ()~~~In patient	ID94080	1						1	Abdominal pain; Asthenia; Conjunctivitis; Dyspnoea; Headache; Lymphadenopathy; Pyrexia; Somnolence	FLU3~CONNAUGHT LABORATORIES~4F51067~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069919	12/27/1994	NH	56.0	56		F	11/21/1994	pt recvd vax; thursday early pm, general itching; dph given; still itching 6dec94; did not see MD;									U	11/16/1994	11/16/1994	0		UNK	UNK	none;	none	none	~ ()~~~In patient	NH94037	1						1	Pruritus	FLU3~CONNAUGHT LABORATORIES~4F51088~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069934	12/27/1994	NY	47.0	47		F	11/01/1994	pt recvd vax;27oct94,late pm, red palms,urticaria wrist,back,trunk; pruritic rash;much improved at time of report 1nov94;tx w/ dph & prednisone x 5 days; no resp distress;				Y					Y	10/25/1994	10/25/1994	0		PVT	PVT	slobid,ventolin,beclorent;	none	pcn, environmental;	~ ()~~~In patient	NY94060	1						1	Pruritus; Rash; Urticaria; Vasodilatation	FLU3~PARKE-DAVIS~02504P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0069939	12/27/1994	NY	76.0	76		F	10/24/1994	pt recvd vax;17oct94 in eve shift very sleepy;18oct no t, BP 102/80; c/o hurting all over; fine crackles both lung fields,cont thru eve, fine crackles lt mid, lower lobe; 19oct 4pm, lungs clear;									Y	10/17/1994	10/18/1994	1	chest x-ray neg;	OTH	UNK			dx: parkinsons;	~ ()~~~In patient	NY94065	1						1	Lung disorder; Myalgia; Somnolence	FLU3~PARKE-DAVIS~00474P~3~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0069940	12/27/1994	NY	29.0	29		F	11/04/1994	pt recvd vax;devel rhinitis,cough,eyes draining purulent material & eyes hurt;sxs worse,very tired,chills,feverish;chest tightened up;difficulty breathing;to hosp via ambulance;pupils became fixed & dilated;bad flu;tx w/ dph IV,dx tests;				Y					Y	10/17/1994	10/17/1994	0	chest x-ray, urine, blood draws at hosp;	OTH	PUB	birth control pills;	none	none	none~ ()~~~In patient	NY94066	1						1	Chest pain; Conjunctivitis; Cough; Dyspnoea; Influenza; Mydriasis; Pupillary disorder; Rhinitis	FLU3~CONNAUGHT LABORATORIES~4F51010~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069952	12/28/1994	AL	80.0	80		M	12/21/1994	pt recvd vax; found dead by his wife approx 2 hrs p/ vax;	Y	12/15/1994							N	12/15/1994	12/15/1994	0		PVT	PVT	none	none	none	~ ()~~~In patient	AL9445	1						1	Unevaluable event	FLU3~PARKE-DAVIS~00374P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0069955	12/28/1994	OK	91.0	91		F	12/08/1994	pt recvd vax;became flushed & short of breath;to er;hx of apnea episodes;rx inhaler to use but pt refuses per daughter;sent home;8dec TC at home; doing fine;				Y					Y	12/07/1994	12/07/1994	0	none	PUB	PUB			hx of apnea episodes	~ ()~~~In patient	OK9473	1						1	Dyspnoea; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~2504BC~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0069956	12/28/1994	MA	78.0	78		M	12/22/1994	pt recvd vax;w/in 2 days,devel t 101; v; joint pain; malaise & previously problematic lt elbow became red & swollen;saw MD 2 days later;md was not particularly convinced that any of the rxn was due to flu vax;				Y					Y	10/25/1994	10/27/1994	2	none	PUB	PUB	vasotec, darvocet prn;	none	asthma,food additive allergies; hypertension;	in pt, flu-like sxs w/ flu vax at age 74;~ ()~~~In patient	MA9453	1						1	Arthralgia; Malaise; Osteoarthritis; Pyrexia; Vasodilatation; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51016~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0069959	12/29/1994	MI	61.0			F	12/15/1994	pt recvd vax;exp itchiness at inject site; pt exp also uncontrollable v, d & inc t on 21oct94;adm to hosp from 23oct94-28oct94; pt has recovered;					Y	6			Y		10/21/1994		na	PUB	OTH				~ ()~~~In patient	33209	1						1	Diarrhoea; Pruritus; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~00974P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0069824	12/30/1994	WA	19.0	19		M	12/30/1994	pt recvd vax; c/o rt arm swelling, diff bending, r/o cellulitis vs venous thrombosis; 1st TYP given 5oct94; 2nd 2dec94;				Y	Y	3			Y	12/02/1994	12/03/1994	1		MIL	MIL		na	nkda	~ ()~~~In patient		1						2	Cellulitis; Hypokinesia; Oedema peripheral; Pain; Oedema peripheral	FLU3~PFIZER\WYETH~4948203~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TYP~PFIZER\WYETH~4938265~2~IM A~~TYPHOID VI POLYSACCHARIDE (ACETONE INACTIVATED DRIED)~1|TYP~PFIZER\WYETH~4938265~2~IM A~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0069964	12/30/1994	MA	71.0	71		U		shingles + GBS;										10/12/1994	11/09/1994	28		PVT	PVT				~ ()~~~In patient	MA9448	1						1	Guillain-Barre syndrome; Herpes zoster	FLU3~CONNAUGHT LABORATORIES~02504P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069965	12/30/1994	MA	66.0	66		F		pt recvd vax;48 hrs later,itchy arm at inject site;eyes & ha lasting over 72 hrs;as of 14-15nov all sxs gone;									Y	11/09/1994	11/11/1994	2	none	PUB	PUB		sl cold; no cough/no fever		~ ()~~~In patient	MA9449	1						1	Headache; Pruritus	FLU3~CONNAUGHT LABORATORIES~4F51025~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069966	12/30/1994	MA	76.0	76		F	11/16/1994	pt recvd vax; w/in 3 hrs pt states abdo became distended; n; ha, felt like sand trickling thru eyes,lasted for 24 hrs;									Y	11/09/1994	11/09/1994	0	none	PUB	PUB	synthroid betoptics, S eye Gtts;	1 wk prior had general malaise		~ ()~~~In patient	MA9450	1						1	Abdominal distension; Eye disorder; Headache; Nausea	FLU3~CONNAUGHT LABORATORIES~4F51025~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069982	01/03/1995	NY	64.0	64		M	12/05/1994	pt recvd vax; has pain in the shoulder, lt elbow & arm; arm was very red;to MD who said pt had pre-existing condition on elbow a/ & lt shoulder;x-rays done;									Y	11/17/1994	11/28/1994	11	x-rays	PUB	PUB	na	na	lt elbow arthritis/lt shoulder bursitis	none~ ()~~~In patient	BA94M030	1						1	Arthralgia; Condition aggravated; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51006~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1682W~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0069986	01/03/1995	IL	2.0	2	.3	M	11/30/1994	pt recvd vax; tues 2am started fever & rt arm started to swell;at 1pm tues fever 106 & at that time had convuls; adm to hosp;					Y	1			U	11/27/1994	11/28/1994	1	blood count & cultures;	PUB	PUB		none	asthma	na~ ()~~~In patient	IL940148	1						1	Asthma; Convulsion; Oedema peripheral; Otitis media; Pneumonia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51087~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0962A~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0069989	01/03/1995	MA	70.0	70		F	12/20/1994	pt recvd vax;exp sore arm same day as vax; felt irritable & flip floppy; 1 wk later;rash on neck,shoulders,hair,arms & itchy all over;8 days later eye became pink & stuffy; saw MD who said flu shot rxn;									Y	11/14/1994	11/14/1994	0	none	PUB	PUB	unk	none	none	~ ()~~~In patient	MA9451	1						1	Agitation; Conjunctivitis; Face oedema; Hypotonia; Myalgia; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~4F51016~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0069995	01/03/1995	AZ	67.0	67		F	12/08/1994	pt recvd vax; pt's daughter reported, pt adm to hosp 1 wk later w/ dx of GBS;			Y		Y			Y		10/17/1994	10/18/1994	1		UNK	UNK			asthma, lupus	~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0069996	01/03/1995	LA	55.0	55		F	12/20/1994	pt recvd vax; dx w/ GBS;adm to hosp x 2 wks;recovering well;apparently no long term effects;no certainty that flu vax was the culprit			Y	Y	Y	14			Y	10/12/1994	10/26/1994	14		PUB	PVT	unk	unk	unk	~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLU3~PFIZER\WYETH~4948106~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0069997	01/03/1995	VA	60.0	60		M	12/23/1994	pt recvd vax; adm to hosp 9dec w/ weakness in legs;tx for GBS w/ IV IgG,complete recovery;					Y	6			Y	09/09/1994	12/09/1994	91	CBC ,SMA 18, T4 TSH Mg, aldolose, sed rate all were WNL;	PVT	PVT	inderal, cardizem, pravachol	hypertension,coronary disease	hypertension, coronary disease	~ ()~~~In patient		1						1	Guillain-Barre syndrome; Myasthenic syndrome	FLU3~PFIZER\WYETH~4948109~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0070000	01/03/1995	WI	44.0	44		F	12/30/1994	pt recvd vax; soreness into lt wrist; next day reddened & erythema approx 10 cm in diam;appears to be cellulitic;poss mycoplasma infect,bronchitis;local rxn to pneumovax;upper resp infect;;vesicular eruption;bronchitis;sore throat,migraine				Y					Y	10/12/1994	10/12/1994	0		PVT	PVT				~ ()~~~In patient		1						1	Bronchitis; Cellulitis; Hypersensitivity; Infection; Injection site hypersensitivity; Injection site mass; Migraine; Myalgia	FLU3~PFIZER\WYETH~4948124~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~UNKNOWN MANUFACTURER~380959~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0070001	01/03/1995		24.0	24		M	12/21/1994	React Uneval				Y					Y	12/19/1994	12/19/1994	0		MIL	MIL	excedrin	none	none			1						1	Unevaluable event	FLU3~PARKE-DAVIS~00284P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|TYP~PFIZER\WYETH~4938260~3~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0070002	01/03/1995	VA	55.0	54		M	12/27/1994	pt recvd vax;3-4 days later devel ache in groin,general aches & pains,low grade t;all exams w/in nl limits;referred to urologist since sxs persist;				Y					N	11/03/1994	11/07/1994	4	blood chemistry,PSA, CBC,urinalysis,X-ray,CT scan of spine,abdo,flexible sigmoidoscopy;	OTH	PUB	calan	none	borderline hypertension	~ ()~~~In patient		1						1	Myalgia; Pain; Pelvic pain; Pyrexia	FLU3~PFIZER\WYETH~4948197~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0070006	01/03/1995		64.0	64		F		pt recvd vax;c/o tremors,movement dis;shaky;incordination,somewhat lightheaded w/in couple of wks p/vax;difficulty ambulating,poor balance;some n,no fever,chills or sxs suggesting viral illness;feels weak all over;cholesterol=278;bil=1.1;					Y					11/03/1994	11/05/1994	2	no oth lab abnl x/ ANA 1:160,CT head scan nl;cholesterol=278;bil=1.1;BUN & serum electrolytes nl;white blood count=8150 w/ hemglobin of 14.8 & 363,000 platelets;Monocytes=9.1%;EKG showed sinus rythm;	UNK	UNK	dyazide, thyroid		hypothyroidism, hypertension	~ ()~~~In patient		1						1	Cerebral infarction; Coordination abnormal; Eye disorder; Laboratory test abnormal; Movement disorder; Tremor; Visual disturbance	FLU3~CONNAUGHT LABORATORIES~4F51006~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0070010	01/04/1995	RI	46.0	46		M	12/21/1994	pt recvd vax; reemergence of Reiter's synd 1 wk p/vax; also GBS;					Y				Y	11/02/1994	11/09/1994	7		PVT	PVT		none	allergies,asthma,Reiters;	none~ ()~~~In patient		1						1	Condition aggravated; Guillain-Barre syndrome; Hypoaesthesia	FLU3~CONNAUGHT LABORATORIES~4F51085~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0070014	01/04/1995	MA	56.0	55		M	12/28/1994	pt recvd vax; sore throat, fever 102 x 4 days; chills, aches, ha; events lasted x 3 wks;bed rest, fluids, vitamin C daily				Y					U	11/01/1994	12/07/1994	36	throat culture taken, results neg;	PUB	OTH	na	na	na	~ ()~~~In patient		1						1	Chills; Headache; Myalgia; Pharyngitis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0070015	01/04/1995	MA	37.0	37		F	12/29/1994	pt recvd vax; 24 hrs later,felt achy,low grade t;30 hrs p/ shot devel high fever, severe aches; cold sx; n; sl red rash chest;				Y					Y	11/03/1994	11/04/1994	1	none	UNK	UNK	lo-ovral, deconsal-la, maxair & aerobid inhaler;	none	natural sources, asthma; reactive hypoglycemia	none~ ()~~~In patient		1						1	Myalgia; Nausea; Pharyngitis; Pyrexia; Rash; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0070017	01/04/1995	IL	35.0	35		F	11/23/1994	pt recvd vax;broke out in hives eve of inject;to MD,was given a kenalog inject & po atarax;sxs persistant;back to MD again;was given medrol dose pk pf prednisone;this drug effective p/ 2nd dose				Y					Y	11/01/1994	11/01/1994	0		OTH	OTH		none	none	~ ()~~~In patient		1						1	Urticaria	FLU3~PFIZER\WYETH~4948048~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0070029	01/05/1995	NJ	48.0	48		M	12/27/1994	double vision & visual distrubances; confused; paranoia; ataxia; creutzfeldt-Jakob; since admission pt become unresponsive w/random knee jerks & is in a stupor; dx encephalopathy (post-vax?) & r/o Creutzfeldt-Jakob disease;			Y	Y	Y		Y		N	10/27/1994	11/14/1994	18	EEG constant discharge	PUB	UNK	NONE	Healthy	NONE	unk~ ()~~0.00~Patient	NJ9474	1						1	Confusional state; Coordination abnormal; Depressed level of consciousness; Electroencephalogram abnormal; Encephalopathy; Paranoia; Stupor; Visual disturbance; Confusional state; Coordination abnormal; Diplopia; Encephalopathy; Infection; Paranoia; Stupor; Visual disturbance	FLU3~CONNAUGHT LABORATORIES~4F51158~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~4F51158~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0070032	01/05/1995	CT	59.0	59		M	12/22/1994	Guillain-Barre Synd				Y					N	10/01/1994	10/24/1994	23	EMG, Lumbar Puncture c/w GBS	UNK	UNK				~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0070033	01/06/1995	OH	66.0	66		M	10/26/1994	Pt recvd vax & exp anxiety, h/a, stiff neck, burning upset stomach, insomnia, heard a pulse in ears, skin felt creepy 2-3 hrs p/vax; IGG was lowered unable to fend off infections; Intraocular pressure 14 on 15AUG93 & 26 on 20OCT93										10/19/1993	10/20/1993	1	13DEC93 IGG 553 abn; IGE 126 nl;	UNK	UNK	Tenormin, Timoptic, APAP, Oxazepam, Bellergal, Esgic		Hypertension, Myocardial infarction, Glaucoma, Allergy to ASA, Iridotomay both eyes; Dyshidrotic eczema	~ ()~~~In patient		1						1	Anxiety; Condition aggravated; Dyspepsia; Headache; Immunoglobulins increased; Infection; Insomnia; Nuchal rigidity	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0070034	01/06/1995	IL				F	10/26/1994	pt recvd vax & exp black & blue marks, red stripes, & an indentation @ the inject site on the buttock; pt also exp pain @ the inject site described as a pinching & pulling feeling; area of atrophy @ the inject site measures 4cm in length;										10/01/1992			unk	UNK	UNK	Kenalog		dermatoses	~ ()~~~In patient		1						1	Ecchymosis; Injection site atrophy; Injection site pain; Skin striae	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0070035	01/06/1995	NY	85.0	85		M	12/14/1994	pt recvd vax 27OCT94 & was admitted to the hosp for treatmnet of thrombocytopenia; pt is currently in the ICU, receiving steroids, gamma globulin & plasmapheresis;			Y		Y	9			N	09/28/1994	12/10/1994	73	Platelt count 1,000/cumm;	PVT	PVT	unspecified antihypertensive;	NONE	Hx of hypertension;	~ ()~~~In patient	894350003S	1						1	Thrombocytopenia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0070036	01/06/1995	OR				M	12/07/1994	pt recvd fluv vax & 2 wks later pt suffered myocardial infarction w/subsequent development of ventricular fibrillation; pt required mechanical ventilation for approx 10 days;					Y	21			U					OTH	OTH	unk	unk	Pt has hx of diabetes & myocardial infarction;	~ ()~~~In patient	894346002S	1						1	Myocardial infarction; Respiratory disorder; Ventricular fibrillation	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0070037	01/06/1995	OR				F	12/07/1994	pt recvd vax & devel pneumonia which led to resp failure; pt was intubated & mechanically ventialated for  about 10 days; pt is now in a rehabilitation center;					Y	30			U					PVT	OTH	unk	unk		~ ()~~~In patient	894346003S	1						1	Apnoea; Pneumonia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0068770	01/09/1995	MO	54.0	54		F	01/03/1995	pt recvd vax;ha,pain in rt arm & shoulder;back pain on 9nov94 into legs w/ numbness in feet,toes & fingers;seen in ofc 11nov94 w/ weakness in feet & throat w/ difficulty swallowing;adm to hosp w/ provisional dx of GBS;				Y	Y				U	11/01/1994	11/08/1994	7		PVT	PVT	zocor	none	high cholesterol	~ ()~~~In patient	CO5703	1						2	Back pain; Dysphagia; Guillain-Barre syndrome; Headache; Myasthenic syndrome; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51015~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0070029	01/09/1995	NJ	48.0	48		M	01/03/1995	pt recvd vax;double vision;when parked car,became confused,could not remember where;adm to hosp w/ visual disturbances,paranoia & ataxia;since adm has become unresponsive,knee jerks,ia a stupor;dx:encephalopathy,R/O Creutzfeldt-jakob diseas. The follow up states he is being treated with steroids. From follow up info received on 6/14/00, it was reported that the pt died on 5/25/95. From follow up correspondence received on 7/6/00, it was reported, Unable to supply report of post mortem exam. No further info is expected, this case is closed. No new info was provided from follow up correspondence received on 7/11/00.	Y	05/25/1995			Y				N	10/27/1994	11/14/1994	18		PUB	PUB	none	none	none		CO5759	1						2	Confusional state; Coordination abnormal; Depressed level of consciousness; Electroencephalogram abnormal; Encephalopathy; Paranoia; Stupor; Visual disturbance; Confusional state; Coordination abnormal; Diplopia; Encephalopathy; Infection; Paranoia; Stupor; Visual disturbance	FLU3~CONNAUGHT LABORATORIES~4F51158~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~4F51158~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0070231	01/09/1995	NY	64.0	64		F	01/03/1995	pt recvd vax;hands mildly shaky 3 days p/vax;mild incoordination,somewhat lightheaded;difficulty ambulating,poor balance;vision began to change;opsoclonus w/ irregular mvmt of arms & legs;small high brain stem lesion associated w/ myoclonus				Y	Y				N	11/03/1994	11/06/1994	3		PVT	UNK	dyazide, thyroid med	none	hypertension, thyroidectomy in 1973	~ ()~~~In patient	CO5758	1						1	Coordination abnormal; Delirium; Eye disorder; Movement disorder; Myoclonus; Neoplasm; Tremor	FLU3~CONNAUGHT LABORATORIES~4F51006~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0070240	01/09/1995	CA	64.0	64		F	12/15/1994	pt recvd vax;began to exp n & v along w/ sxs of the flu;sxs cont until death;pt did not seek med help;cause of death cardiac tamponade due to ruptured myocardial infarction & coronary atherosclerosis;	Y	12/04/1994							N	11/10/1994	11/17/1994	7		PUB	PUB	unk	none		unk~ ()~~~In patient	CA94160	1						1	Arteriosclerosis; Influenza; Myocardial infarction; Nausea; Pericardial effusion; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51025~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0070241	01/09/1995	CA	78.0	78		M	11/14/1994	pt recvd vax;sneezing,eyes burning,sore throat,trouble breathing;diaphoretic;chest pain;anxiety;BP 184/94;P=96;anaphylaxis;exacerbation of obstructive pulmonary disease;;fever,runny nose;nonspecific st abnormality;abnl ECG				Y	Y	4			Y	11/09/1994	11/09/1994	0	abnl ECG;non specific ST abnl	PUB	PUB	nitro-PRN;	has been seeing heart MD	hx of chronic obstructive pulmonary disease;coronary artery disease & cardiacc dysrhythmias;	in pt,rxn to flu shot before,achy body, w/ flu vax;~ ()~~~In patient	CA94161	1						1	Anaphylactoid reaction; Anxiety; Chest pain; Condition aggravated; Dyspnoea; Electrocardiogram abnormal; Hypertension; Tachycardia	FLU3~CONNAUGHT LABORATORIES~4F51025~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0070242	01/09/1995	CA	44.0	44		F	11/28/1994	pt recvd vax;5 hrs later,severe chills;v;diarrhea & some constriction of her throat,lasted x 6 hrs;next day was weak;has recvd vax x last 5 yrs & has had no rxn before;pt states felt great before shot given;									Y	11/23/1994	11/23/1994	0	none	PUB	PUB	none	none	none	none~ ()~~~In patient	CA94162	1						1	Asthenia; Chills; Diarrhoea; Laryngospasm; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51025~6~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0070243	01/09/1995	CA	68.0	68		F	11/17/1994	pt recvd vax;mild ha; body aching,legs worse									Y	10/18/1994	10/18/1994	0	none	PUB	PUB	none	none	has two slipped discs-lumbar	~ ()~~~In patient	CA94163	1						1	Headache; Myalgia	FLU3~CONNAUGHT LABORATORIES~4F51016~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0070246	01/09/1995	CA	69.0	69		M	12/01/1994	pt recvd vax;had chilly sensation,mild body malaise following day;22nov94 feeling numbness on upper lip w/ mild difficulty in swallowing;got worse next day;unable to swallow solid food;to MD 28nov;tx reglan syrup; referred to ENT									Y	11/10/1994	11/22/1994	12		OTH	PUB		none	none	none~ ()~~~In patient	CA94166	1						1	Chills; Dysphagia; Malaise; Paraesthesia oral	FLU3~CONNAUGHT LABORATORIES~4F51016~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0070247	01/09/1995	CA	81.0	81		F	12/08/1994	pt recvd vax;tightness in throat,t 99-100;some sneezing;to MD who dx viral infection & prescribed amantadine;cough non productive;some body aches,weakness;transient mild laryngitis;MD felt illness not related to vax;8dec well but hoarseness				Y					Y	10/25/1994	10/30/1994	5		OTH	PUB	tenormin, ativan	none	cardiac arrythmia; nervousness	none~ ()~~~In patient	CA94167	1						1	Asthenia; Cough; Infection; Laryngitis; Laryngospasm; Myalgia; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~4F51025~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0070255	01/09/1995	ND	50.0	50		F	12/30/1994	on the same evening of receiving vax pt devel h/a, chills, aching, nausea; h/a cont for next 2-3 dasy; also devel sinusitis & bronchitis tx ATB x 3 wks; c/o chills, diaphoresis, flushing 2-3xday; states has no energy; MD states poss virus;				Y						10/20/1994	10/20/1994	0	CRP, WBC has been drawn on a couple occasions w/results being normal	PUB	PVT	Prozac in October, Mexitil, Calan, Premarin, Provera, Synthroid, Seldane, Norpace, relafin, DPH;	NONE	asthma, arthritis, cardiac dysrhythmias, hypertens, allergy to PCN, HCTZ, sulfa	pt exp similar complaints w/flu vax in 1990;~ ()~~~In patient	ND94022	1						1	Asthenia; Bronchitis; Chills; Headache; Hyperhidrosis; Infection; Myalgia; Sinusitis	FLU3~PFIZER\WYETH~4948051~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0070259	01/09/1995	NM	40.0	39		M	12/29/1994	rashes; similar sx to toxic shock but on arms & hands;					Y	5				12/01/1993			unk/blood drawn;	PVT	PUB	Depakote		PCN	~ ()~~~In patient		1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0070262	01/09/1995	OH	57.0	57		F	01/03/1995	post-vaccine synd-myalgias, weakness;					Y	4			Y	11/16/1994	11/16/1994	0		UNK	UNK		NONE		~ ()~~~In patient		1						1	Asthenia; Myalgia; Post vaccination syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0070265	01/09/1995	CA	20.0	20		M	12/02/1994	pt recvd vax 29NOV94 then reported to sick call 2DEC94 w/ c/o rash, swollen throat/tightness; tx Ataxax;				Y					Y	11/29/1994	11/30/1994	1	PE/assessment;	MIL	MIL	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Laryngospasm; Oedema; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0070270	01/09/1995	MN	41.0	41		F	01/04/1995	t102+ x 2 days missed 1 1/2 days of work; rt arm & glands swelled so much could not get a blouse over it; subsided p/3 days;									Y	11/28/1994	11/29/1994	1		PUB	PUB	NONE	NONE	sulfites-sulfur dioxide	~ ()~~~In patient		1						1	Lymphadenopathy; Oedema peripheral; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51087~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SMITHKLINE BEECHAM~1434A4~1~IM~LL~HEP B (ENGERIX-B)~1|PPV~PFIZER\WYETH~1474W~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0070286	01/10/1995	MI	40.0	40		M	12/08/1994	pt recvd vax;3 hrs later devel blood shot eyes,discharging eyes,dyspnea;fever 102;general malaise;to er; tx w/ IV fluids & DPH;				Y					Y	12/06/1994	12/06/1994	0	none	PUB	PUB	none	none	none	none~ ()~~~In patient	MI94174	1						1	Conjunctivitis; Dyspnoea; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51059~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0070288	01/10/1995	MI	53.0	53		F	11/30/1994	pt recvd vax;rt arm shoulder pain,started that eve;difficult to raise arm;cont to be painful;wakes her up at noc;to MD 5dec;given shot of cortisone in rt shoulder;given scripts for motrin,apap;to rest shoulder x 1 wk;MD felt not rxn to vax				Y					U	11/18/1994	11/18/1994	0		PUB	PUB	none	none	none	none~ ()~~~In patient	MI94177	1						1	Hypokinesia; Insomnia; Pain	FLU3~CONNAUGHT LABORATORIES~4F51059~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0070299	01/10/1995	WA	46.0	46		F	01/03/1995	pt recvd flu shot 25OCT94; states devel h/a w/stiff neck & shoulder on arm administered on the 3rd following noc then swollen glands behind both ears lasting 2 more days;									Y	10/25/1994	10/28/1994	3	NONE	PUB	OTH	BC pills, Thyroid Prep, Zestoril	NONE	NKDA; no chronic illnesses	NA~ ()~~~In patient		1						1	Headache; Hypertonia; Lymphadenopathy; Nuchal rigidity	FLU3~PFIZER\WYETH~4948038~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0070306	01/10/1995	CA	41.0	41		F	12/12/1994	pt recvd vax;exp tightness in chest, cough non productive w/in 2 hrs of vax; leg achiness,flushed; ?fever									Y	11/03/1994	11/03/1994	0		UNK	UNK			codeine	~ ()~~~In patient		1						1	Chest pain; Cough; Myalgia; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51025~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0070309	01/10/1995	VA	47.0	47		F	01/05/1995	pt recvd vax;had 10 days of diffuse distal proximal lt arm pain;motor sensory,pulse;joint exams were nl;no crepitus;provisional dx was tendonitis;cont to adm naprosyn (alleve),added warm soaks;sxs gradually resolved over 2 1/2-3 wks;									Y	11/28/1994	12/08/1994	10	none	PVT	PVT		none	none	none~ ()~~~In patient		1						1	Pain; Tendon disorder	FLU3~CONNAUGHT LABORATORIES~4F51129~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0070310	01/10/1995	AR	37.0	37		F	01/04/1995	pt recvd vax;arm hurting immediately p/vax;arm sore throughout wk end,could not use arm;pain cont for wks afterwards									Y	10/28/1994	10/28/1994	0		PVT	PVT				~ ()~~~In patient		1						1	Myalgia; Pain; Hypokinesia; Injection site pain; Myalgia	FLU3~CONNAUGHT LABORATORIES~4F51113~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~4F51113~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0070311	01/10/1995	AR	34.0	34		M	01/04/1995	pt recvd vax;arm began to hurt immediately;could not move arm although pain was not so severe;cont to hurt x wks									Y	10/28/1994	10/28/1994	0		PVT	PVT				~ ()~~~In patient		1						1	Hypokinesia; Pain; Hypokinesia; Pain	FLU3~CONNAUGHT LABORATORIES~4F51113~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~4F51113~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0068942	01/11/1995	PA	72.0	72		M	12/23/1994	pt recvd vax 10OCT94 & 2 days later exp severe vertigo followed by profound sensorineural hearing loss in the lt ear; pt was hospitalized for workup;  lymphocyte transformation assay boarderline pos				Y			Y	Y	N	10/10/1994	10/12/1994	2	MRI-results unk audiogram 23OCT94-imporvement to the 80 decible level; Lymphocyte transformation assay-borderline pos;	PVT	PVT	unk	unk	pt is a smoker; pt was seen in AUG94 by ENT physician c/o cough & throat irritation; bilat cerumen impaction was found @ that time;	~ ()~~~In patient	894357009Z	1						2	Deafness; Laboratory test abnormal; Vertigo	FLU3~PFIZER\WYETH~4948054~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation,Disabling	Influenza
0070522	01/11/1995		65.0			F	01/10/1995	pt vaxed 17OCT94 & 5NOV94 exp epigastralgia; 2 days later exp weakness in legs which gradually inc during the wk; hospitalized on 11NOV94 w/generalized neuropathia in arms/legs bilat peripheral facialis paresis; 21DEC94 pt improving;					Y				U	10/17/1994	11/05/1994	19		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	EML95003	1						1	Dyspepsia; Facial palsy; Myasthenic syndrome; Neuropathy	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0070528	01/11/1995	NC	71.0	71		F	12/14/1994	pt recvd vax 10OCT94 & arm felt warm p/1st day & was hurting; 28OCT94 sore arm could not get arm above head due to soreness; 15NOV94 seen by MD due to arm pain; 9DEC94 nerves are twitching & sore to touch, knot; diff breathing;				Y					N	10/10/1994	10/10/1994	0		PUB	PUB	THyroid, inhalers: Atrovent, Ventolin, Beclovent TID	Emphysema, chronic bronchitis	cholecystectomy-1950's; no allergies, birth defects; Emyphsema, chronic bronchitis	NONE~ ()~~~In patient	NC94140	1						1	Dyspnoea; Hypokinesia; Injection site pain; Myalgia; Nausea; Pain; Skin nodule; Vasodilatation	FLU3~PARKE-DAVIS~00294P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0070536	01/11/1995	WA	40.0	40		F	01/05/1995	pt recvd vax & noticed immed numbness in arm & saw MD next day w/ c/o dec strengthin arm, red welt @ site & on neck, blotchy skin on shoulder; conversation w/MD on exam MD felt this was an extreme local react, not an allerg react;				Y					Y	10/25/1994	10/25/1994	0	NONE	PUB	OTH	Injectable Luprin	NONE	allergic to PCN & Anaprox	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Myasthenic syndrome; Paraesthesia; Rash maculo-papular	FLU3~PFIZER\WYETH~4948038~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0070544	01/12/1995	IL	53.0	53		F	12/23/1994	pt called on 12DEC94 states arm was sore evening p/flu vax given in lt deltoid; progessively got worse for several weeks; currently arms is swollen, warm to touch, w/restricted mobility due to pain; referred to PMD for treatment;									U	10/19/1994	10/19/1994	0	14DEC94 tC pt seen by MD blood tests showed no infect; taking anti-inflamatory med is better;	PUB	PUB		NK	NK	~ ()~~~In patient	IL940152	1						1	Hypokinesia; Myalgia; Oedema peripheral; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51016~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0070582	01/13/1995	PA				F	12/28/1994	pt recvd vax;on 2oct94 adm to hosp w/ a spinal epidural hematoma;pt recovered w/out residua;neurosurgeon states the cause of hematoma is unk;however,does not feel it is related to flu vax;pt will be followed w/ MRI exams;					Y				Y	09/21/1994	10/02/1994	11	Percutaneous needle biopsy & MRI showed only epidural blood clot;	PVT	PVT		none	hx of breast cancer;	rxn unevaluable;~ ()~~~In patient	895003003Z	1						1	Haemorrhage; Quadriplegia	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0070583	01/13/1995	AL	65.0	64		F	12/27/1994	pt recvd vax;pt reports 4 days p/vax,started having numbness in toes both feet but lt side is worse;seen by different MD;on prednisone & imoran; myasthenia now ruled out;final dx: GBS, ?peripheral neritis;					Y			Y	N	10/08/1992	10/12/1992	4	GBS, ? peripheral neritis final dx; myasthenia;	PUB	PUB	none per pt;	none per pt on 27dec94	denies any on 27dec94	~ ()~~~In patient	AL9449	1						1	Guillain-Barre syndrome; Neuropathy peripheral; Paraesthesia	FLUX~PFIZER\WYETH~4928233~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0070591	01/13/1995	MO	41.0	41		F	12/16/1994	pt recvd vax;2 days later,noticed rash (raised red welts) on side of both arms,from armpits to wrists like goosebumps; not itchy; gradually faded, but noticeable for 1 wk;									Y	12/06/1994	12/08/1994	2		PUB	PUB	sodium cromolyn		1985 : rast-egg-white food allergy moderate	in mom,will not take flu shot because previous shots would weeps out;~ ()~~~In patient		1						1	Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0080562	01/14/1995	PA	51.0	51		F		pt recvd pneumovax & flu vax on 3OCT94 & inadvertently recvd 2nd dose of pneumococcal vax 17OCT94 & 18OCT94 pt devel a sore arm & recovered;									Y	10/17/1994	10/17/1994	0	No relevant data;	PVT	PVT				~ ()~~~In patient	WAES94100552	1						1	Myalgia	FLU3~CONNAUGHT LABORATORIES~4F51079~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1417W~2~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0070600	01/17/1995	MS	56.0	56		F	12/28/1994	pt recvd vax;sl swelling around site of reddened area approx 4x3 size; itching badly;									U	12/20/1994	12/25/1994	5		PUB	UNK	none	none	none	~ ()~~~In patient	MS94070	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PARKE-DAVIS~02894P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~CONNAUGHT LABORATORIES~4B61052~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0070607	01/17/1995	SC	10.0	10		F	11/18/1994	pt recvd vax;@ 8:45 fainted;color pale;pupils dilated;hands & arms shaking;less than 1 min;aroused w/ amonia capsule;v;BP 80/52 at 9:10pm; P=82;color fine;discharged at 9:30pm w/ mom;									Y	11/18/1994	11/18/1994	0		PUB	UNK	none	none	mom states pt has asthma;	~ ()~~~In patient	SC94115	1						1	Hypotension; Mydriasis; Pallor; Syncope; Tremor; Vomiting	FLU3~PFIZER\WYETH~4948130~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0070610	01/17/1995	SD	47.0	47		F	01/04/1995	pt recvd vax;started getting cough & shortness of breath;sxs got worse;chest pains & bad ha;felt like had case of terrible flu or a bad heart condition;still felt ill next day;									Y	11/17/1994	11/17/1994	0		OTH	PUB	na	na	only high cholesterol test	na~ ()~~~In patient	SD95002	1						1	Chest pain; Cough; Dyspnoea; Headache; Influenza; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0070625	01/17/1995	NY	68.0	68		F	01/09/1995	pt recvd vax;hissing/ringing in ears constantly;to MD;ear spec;had MRI, blood work all neg;MD put pt on anti-depressants for insomnia;				Y					N	10/07/1994	11/01/1994	25	neg hearing test	PVT	UNK		none	none	none~ ()~~~In patient		1						1	Insomnia; Tinnitus; Insomnia; Sleep disorder; Tinnitus	FLU3~PARKE-DAVIS~00474P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0070637	01/17/1995	NY	68.0	68		M	01/09/1995	pressure in head-hissing, ringing, sharp rings rt through the head;									N	10/07/1994	11/01/1994	25	2 trips to ER; family MD-ear specialist-Neurologist; CAT Scan-blllod test-hearing test;	PVT	UNK		NONE	high blood pressure	NONE~ ()~~~In patient		1						1	Headache; Tinnitus; Insomnia; Sleep disorder; Tinnitus	FLU3~PARKE-DAVIS~00474P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0070644	01/17/1995	MS	47.0	47		F	01/10/1995	lt hand felt asleep beginning about 10-12 hrs p/vax & lasting 12-14 hrs gradually dec-using lt hand & arm felt awkward;									Y	11/03/1994	11/13/1994	10	NONE	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51088~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0070654	01/17/1995	KY	14.0	14		M	12/29/1994	18 hrs post inject egg sized, warm tender,mass inject site in rt deltoid; no fever; tender in rt axilla; pneumovax given in lt arm w/o discomfort;									U	12/27/1994	12/29/1994	2	probably recovering from pneumonia;	PVT	PVT	Ceftin	resolving pneumonia	asthma	~ ()~~~In patient		1						1	Injection site pain; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4948121~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~380956~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0070657	01/17/1995	TN	66.0	66		F		diarrhea started 14OCT93 the day p/the shot & cont for 12 days-gradually improving;									Y	10/13/1994	10/14/1994	1		PVT	UNK	Cardene; Tenormin;	NONE	aortic aneurism, HBP, angio-edema-hives	~ ()~~~In patient		1						1	Diarrhoea	FLU3~PFIZER\WYETH~4849121~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0070658	01/17/1995	TN	65.0	65		M	01/10/1995	pt exp severe upper resp infect for 30 days; it cleared up but persistent continuing h/a followed-still present-3 months later;									N	10/13/1994	10/16/1994	3	CAT Scan of brain-sl sinus inflamation	PVT	PVT	Lanoxin, Tenormin, nasa cort		atrial fibrillation; pollen, mold, dust allergy	~ ()~~~In patient		1						1	Headache; Pharyngitis; Sinusitis	FLU3~PFIZER\WYETH~4849121~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0070668	01/19/1995					U		pt exp diarrhea, h/a, nausea, inc temp, vaginal bleeding small & large volumes; sx cont p/plane trip inc bruisability on calves;										11/28/1994	11/28/1994	0		UNK	UNK			non-confirmed back & foot injuries-bone scan poss MR necessary; poss microadenona pituitary;	~ ()~~~In patient		1						1	Diarrhoea; Ecchymosis; Headache; Nausea; Pyrexia; Vaginal haemorrhage	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0070669	01/19/1995	NY	24.0	23		F	01/17/1995	GBS				Y	Y	14				10/14/1994				OTH	PVT				~ ()~~~In patient		1						1	Guillain-Barre syndrome; Guillain-Barre syndrome	FLU3~PARKE-DAVIS~00684P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00684T~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Hospitalisation	Influenza
0070670	01/19/1995	CT	57.0	57		M	01/16/1995	GBS				Y	Y	7			Y	10/17/1994	10/26/1994	9	NONE	PVT	PVT	Mevacor	NONE	hypercholesterolemia	NONE~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLU3~PFIZER\WYETH~4948114~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0070673	01/19/1995	MA	56.0	56		F	01/13/1995	started w/sore throat, dizziness, sinus blocked-breathing wheezy-went to MD bronchitis cold;										10/21/1994	11/25/1994	35		PUB	UNK				~ ()~~~In patient		1						1	Asthma; Bronchitis; Dizziness; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0069851	01/20/1995	OH	62.0	62		F	12/27/1994	pt recvd vax;to er w/ back pain & weakness in both lower extremities; no real sensory deficit;no fever;vital signs nl x/ BP 162/90;adm to hosp 29nov then discharged 5dec;dx of GBS;				Y	Y	9			Y	11/04/1994	11/17/1994	13	CSF (inc protein 114 MR/O2) fluid clear,colorless;initial X-ray spine neg;	PUB	PUB		none	denies	~ ()~~~In patient	OH95002	1						2	Back pain; CSF test abnormal; Guillain-Barre syndrome; Hypertension; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~4F51016~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0070692	01/20/1995	AZ	79.0	79		F	01/12/1995	pt recvd vax;n,ha,fever,d,aching bones 3-4 days p/ shot;saw MD;gave rx, pt not aware of what med was;cont to have cough,tired & some occasional n;infl virus pos;				Y					Y	11/16/1994	11/19/1994	3	SMAC,cardiac risk;CBC,thyroid, Infl A virus pos;had lab test,unsure about what type;	PUB	PUB	none	none per pt	none	in pt,had flu vax 2-3 yrs ago w/ sxs~ ()~~~In patient		1						1	Asthenia; Bone pain; Cough; Diarrhoea; Headache; Infection; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F61008~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0070705	01/23/1995	IN	46.0	46		F	01/18/1995	h/a; severe enough that needed to lie down in the evening of 7NOV994; also had general malaise; c/o h/a started the same day of vax 4NOV94; 10NOV94 pt exp sz, then passed out; sx ruptured cerebral aneurysm; pt had surgery 11NOV94 & died;	Y	11/17/1994			Y				N	11/04/1994	11/04/1994	0		OTH	OTH		NONE	heart condition not requiring medication	~ ()~~~In patient	CO5678	1						1	Apnoea; Convulsion; Headache; Intracranial aneurysm; Malaise; Subarachnoid haemorrhage; Syncope	FLU3~CONNAUGHT LABORATORIES~4F51165~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0070707	01/23/1995	FL	55.0	54		M	01/03/1995	GBS-no strengh; numbness & tingling 9 fingers rt foot- 2 & 3rd toes, upper gum numb, weakness problem swallowing, nose numb, tongue, top lip numb, nerve ripples up neck to head;				Y					N	11/15/1994	12/03/1994	18	nerve conduct 22DEC94 studies;	OTH	PUB	Uricet K	NONE	kidney stones, borderline, HTN	~ ()~~~In patient	FL95002	1						1	Asthenia; Dysphagia; Guillain-Barre syndrome; Pain; Paraesthesia; Paraesthesia oral	FLU3~CONNAUGHT LABORATORIES~E2584HH~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0070713	01/23/1995	NV	27.0	27		M	12/03/1994	c/o generalized body malaise which progressed to weakness w/high grade temp, chest congestion, coughing & inability to do physical works; pt took Amoxicillin, felt somehow better, but went to see MD & given Augmentin & Dexamethasone shot;				Y					Y	10/12/1994	10/14/1994	2	NA	PUB	PUB	NONE	NONE	NONE	NOE~ ()~~~In patient	NV94031	1						1	Asthenia; Cough; Lung disorder; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51024~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~380957~1~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0070716	01/23/1995	OH	60.0	60		M	01/10/1995	same day vax given pt slept in truck overnoc & went fishing all day the following day; pt noted numbness upper posterior arm & pinching sensation to elbow; pt stated had associated pain @ sites also; seen by MD tx by chiropractor w/heat;				Y					U	11/15/1994	11/17/1994	2	NONE	PUB	PUB	unk	NONE	NONE	~ ()~~~In patient	OH95004	1						1	Arthralgia; Injection site pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51072~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0070727	01/23/1995	NC	20.0	20		M	01/17/1995	pt recvd vax & returned in 40 mins c/o dizziness; administered 02 via nasal cannula, & 50mg inject of DPH & Epi; taken to hosp; pt adm & discharged;				Y	Y	1			Y	01/10/1995	01/10/1995	0		MIL	MIL	NONE	NONE	NONE	~ ()~~~In patient		1						1	Dizziness	FLU3~PFIZER\WYETH~4948203~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~3J51046~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1|TYP~PFIZER\WYETH~4938266~1~IM~RA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0070742	01/23/1995	IL	70.0	70		F	12/28/1994	pt recvd vax;sxs began 4th day p/ vax; feeling like she was going to pass out;pounding all over body;jumping muscles;heart palpitations;legs ache;difficulty swallowing;n & weakness;shortness of breath;									Y	11/04/1994	11/08/1994	4		PVT	PVT			hypertension	~ ()~~~In patient		1						1	Asthenia; Dizziness; Dysphagia; Dyspnoea; Myalgia; Nausea; Palpitations	FLU3~PARKE-DAVIS~00184P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0070749	01/23/1995	CA				F	01/18/1995	pt recvd vax;mac pap erythematous pruritic rash 1 day p/ vax;									Y				na	PVT	PVT	premarin	none	HTN, asthma	~ ()~~~In patient		1						1	Pruritus; Rash maculo-papular	FLU3~PFIZER\WYETH~4948118~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~UNKNOWN MANUFACTURER~~1~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0070750	01/23/1995	FL	76.0	76		M	01/12/1995	pt recvd vax;claimed been unsteady on feet									U	11/23/1994				PVT	PVT				~ ()~~~In patient		1						1	Dizziness	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0070758	01/24/1995	PA	66.0	66		M	01/21/1995	pt recvd vax;double vision, 3 days following flu & pneumonia shot;tested pos for myasthenia gravis				Y					N	10/11/1994	10/14/1994	3	MRI, EMG,blood test, CAT scan;	OTH	OTH	none	none	none	~ ()~~~In patient		1						1	Diplopia; Myasthenic syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0070776	01/25/1995	GA	64.0	63		F	11/07/1994	pt recvd vax; pt reported redness,warm feeling w/ blister like patches to inject site;sxs started 4nov94,site very sore;				Y					U	10/27/1994	11/04/1994	8		PUB	PUB	none	none	none	none~ ()~~~In patient	GA94171	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PARKE-DAVIS~00294P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~CONNAUGHT LABORATORIES~4A61008~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0070781	01/25/1995	GA	43.0	43		F	11/29/1994	pt recvd vax;woke up in am w/ fever,chills,ha,n,d & upper resp infect;called MD; was placed on cipro;				Y					Y	11/22/1994	11/23/1994	1	na	PUB	PUB	nasal spray,proventil inhaler,vancenil inhaler,robax,ASA,procardia,atarx,prednisone,lasix,micro K	none	diabetic,heart disease,chronic lung problems;	na~ ()~~~In patient	GA94176	1						1	Chills; Diarrhoea; Headache; Nausea; Pharyngitis; Pyrexia	FLU3~PARKE-DAVIS~01664P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~380955~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0071058	01/27/1995	TX	43.0	43		F	12/23/1994	pt recvd vax; pain at inject site, feeling weakness, weakness of lower limbs;				Y					Y	11/15/1994	11/15/1994	0		OTH	OTH	unk	bronchial asthma	bronchial asthma	~ ()~~~In patient	TX94527	1						1	Asthenia; Injection site pain; Myasthenic syndrome	FLU3~PFIZER\WYETH~4948146~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0070669	01/30/1995	NY				F	01/23/1995	pt recvd vax & contracted GBS- the onset of which occurred about 10 wks p/recvd flu vax from another MD;					Y					10/14/1994	12/01/1994	48		PVT	UNK			Bell's palsy	~ ()~~~In patient		1						2	Guillain-Barre syndrome; Guillain-Barre syndrome	FLU3~PARKE-DAVIS~00684P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00684T~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Hospitalisation	Influenza
0071084	01/30/1995	AK	70.0	70		F		pt recvd vax; fever,chills,n,v;dizzy,unable to func;coughing,chest congest,t 102;could not get out of bed Thurs & Fri;was sick about 2 wks;									Y	10/26/1994	10/26/1994	0	none	PUB	UNK			arthritis	~ ()~~~In patient	AK94020	1						1	Chills; Cough; Dizziness; Lung disorder; Nausea; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51165~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0145A~1~IM~~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~4B61052~2~IM~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0071085	01/30/1995	AK	36.0	36		M	11/22/1994	pt recvd vax;difficulty getting a breath;started sometime p/ got flu shot;episodes last for 30 mins; occur to 2x per day;										10/28/1994			none	UNK	UNK				~ ()~~~In patient	AK94021	1						1	Dyspnoea	FLU3~CONNAUGHT LABORATORIES~4F51165~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0071095	01/30/1995	CA	67.0	67		F	11/22/1994	pt recvd vax; sterile abcess rt deltoid w/ induration,pain,warmth day p/ vax & gradual progression over following wk;									Y	11/14/1994	11/15/1994	1		PUB	PUB		none	pcn	~ ()~~~In patient	CA95006	1						1	Injection site abscess; Injection site mass; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51025~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0145A~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~4F61058~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0071097	01/30/1995	CA	67.0	67		F	01/10/1995	pt recvd vax;redness & swelling of arm to below elbow;felt weak & ill;fever & chills;t 104;to er w/ cellulitis;IV atb & po atb given;pain,redness &swelling dec by 13dec;well by 25dec;				Y					Y	12/06/1994	12/07/1994	1		PUB	PUB	vitamins	well	allergic to pcn	none~ ()~~~In patient	CA95008	1						1	Asthenia; Cellulitis; Chills; Malaise; Oedema peripheral; Pain; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51016~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0145A~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0071109	01/30/1995	NJ	64.0	64		F	01/24/1995	pt recvd vax & later contracted GBS; pt also exp cold x 3-4 wks; 30DEC94 called MD exp excruciating back pain; 4JAN95 pt examined by MD face & eye were drooping on lt side; pt adm to ICU;				Y	Y		Y		N	10/31/1994	10/31/1994	0	x-rays; CAT scan; Western blot	PUB	PVT			HTN	~ ()~~~In patient		1						1	Asthenia; Back pain; Eyelid ptosis; Guillain-Barre syndrome; Hypotonia; Pharyngitis; Rhinitis; Arthritis; Asthenia; Guillain-Barre syndrome; Hypokinesia; Neck pain	FLU3~CONNAUGHT LABORATORIES~4F51067~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~4H51067~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0071118	01/30/1995	MA	59.0	59		F	01/20/1995	pt recvd vax 3NOV94 @ 1130 & 230PM didn't feel well-throat started to close so pt took allerest; BP 160/104-nl 136/80; eyesight blurred; 4 days later eyesight ok; 3 1/2 wks later BP ok; no fever;									Y	11/03/1994	11/03/1994	0		PUB	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Amblyopia; Hypertension; Laryngospasm; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0071146	01/31/1995	PA	65.0	65		F	12/27/1994	pt recvd vax; w/in 15 mins became very dizzy & diaphoretic;BP 90/60;seen at hosp er;EKG ok, no problems noted;no oth local or systemic sxs devel;				Y					Y	10/07/1994	10/07/1994	0		PUB	PUB				~ ()~~~In patient	PA9530	1						1	Dizziness; Hyperhidrosis; Hypotension	FLU3~PFIZER\WYETH~4948122~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0071147	01/31/1995	PA	46.0	46		F	12/27/1994	pt recvd vax;rt arm very painful;egg sized lump at inject site;redness 5 in diam from shoulder to elbow;overall achiness; T 100;tx w/ erythromycin,biaxin,dph & steroids over a period of 4 wks;seen urgent care;				Y					Y	09/26/1994	09/27/1994	1		PUB	PUB			had splenectomy early's 1970's	~ ()~~~In patient	PA9532	1						1	Injection site hypersensitivity; Injection site mass; Myalgia; Pain; Pyrexia	FLU3~PFIZER\WYETH~4948122~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~370945~2~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0071166	01/31/1995	PA	47.0	47		F	11/08/1994	pt recvd vax;numbness of hands & feet then progressed to lips & mouth;28oct,cough,fatigue,muscle weakness;to MD & given cortisone inject & ATB,sxs became worse in eve of 28oct;29oct was adm to hosp; PE=absent reflexes in arms & legs; tx wp;				Y	Y	10			N	10/12/1994	10/27/1994	15		OTH	PUB	tenormin	none	hypertension		PA9552	1						1	Asthenia; Cough; Guillain-Barre syndrome; Hyporeflexia; Myasthenic syndrome; Paraesthesia; Paraesthesia oral	FLU3~PFIZER\WYETH~4948067~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0071174	01/31/1995	PA	60.0	60		F	10/16/1994	16OCT had blotching on face, chin arms; denies fever; mild pruritis; seen by MD on 17OCT;									Y	10/11/1994	10/16/1994	5	NONE	PUB	PUB	unk	NONE	NONE	~ ()~~~In patient	PA9560	1						1	Pruritus; Rash maculo-papular	FLU3~PFIZER\WYETH~4948066~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0071176	01/31/1995	PA	66.0	66		M	10/11/1994	chills, generalized achiness & productive cough, sweats & fatigue, rhinorrhea, diaphoresis;				Y					N	10/06/1994	10/07/1994	1		PUB	PUB			arthritis, ssinusitis, high blood resolved in AUG94	unk~ ()~~~In patient	PA9562	1						1	Asthenia; Chills; Cough; Hyperhidrosis; Myalgia; Rhinitis	FLU3~PFIZER\WYETH~4948129~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0071185	01/31/1995	CA	66.0	66		M	01/24/1995	pt recvd vax 24OCT94 & exp inc weakness of legs; pt states that by 24NOV was having to compensate for weak legs by leaning against counters, etc; dx GBS;					Y	19			N	10/24/1994	11/15/1994	22		PVT	PVT	Vasotec, Tene, asthma inhaler, Xanax	NONE	HTN, asthma; panic & anxiety disorders;	NONE~ ()~~~In patient		1						1	Guillain-Barre syndrome; Myasthenic syndrome	FLU3~PARKE-DAVIS~00274D~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0071186	01/31/1995	CA	53.0	53		M	01/24/1995	pt recvd vax 18NOV94 & w/in 1/2 an hr pt started to feel weak & tired; pt went home early & slept whole weekend; returned to work 20NOV; 1DEC noted numbness & coolness of both feet; 5DEC fell at work & was taken to hosp; dx GBS;					Y	38			N	11/18/1994	11/18/1994	0	LP; elevated protein-83%; CBC & SMAC-20 nl;liver function test became abn;MRI of cervical & thoracic region nl; CAT of head nl; conduction velocity & latency studes of both the upper & lower extremities showed scattered borderline reduction	OTH	PVT	NONE	recovering from mild URI	NONE	NONE~ ()~~~In patient		1						1	CSF test abnormal; Guillain-Barre syndrome; Hyporeflexia; Myasthenic syndrome; Orthostatic hypotension; Paraesthesia; Paraplegia; Peptic ulcer	FLU3~PFIZER\WYETH~4948072~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0071187	01/31/1995	PA	70.0	70		F	11/04/1994	pt recvd vax & was found to have a large ulceration of mucous membrane mouth & areas of inflammation of tongue; platelets found to be 6,000; prev blood work done 1OCT94 platelets of 242,000; adm dx idiopathic thrombocytopenia;					Y	8			Y	10/17/1994	10/25/1994	8	25OCT94 platelet 6,000	PVT	OTH	Delorar, Lasix	NONE	NKA, hx of chronic renal failure, angina, CAD	~ ()~~~In patient		1						1	Glossitis; Mouth ulceration; Thrombocytopenia	FLU3~CONNAUGHT LABORATORIES~4928134510~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0071192	01/31/1995	PA	36.0	36		F	12/27/1994	became lightheaded; inject site @ rt arm itchy, swollen, hot to touch, red; seen @ ER: tx Atarax				Y					Y	10/04/1994	10/04/1994	0		PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Dizziness; Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4948107~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0071193	01/31/1995	NC	21.0			F	12/19/1994	pt recvd vax & went to urgent care w/fever of 103, flu-like sx; arm was not giving much trouble; pt recovered w/no sequelae-addtl pt has never recvd a pneumococcal vax;				Y					Y	11/09/1994	11/09/1994	0		PVT	UNK	Insulin			~ ()~~~In patient		1						1	Influenza; Pyrexia	FLU3~PFIZER\WYETH~4948115~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~372977~1~SC~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0071201	02/01/1995	GA	65.0			M	01/18/1995	approx 3 wks prior to onset of signs & sx compatable w/GBS pt had mild motor defecits which persisted requiring hospitalization @ local rehab center;					Y	5			Y				findings EMG suggestive of GBS	MIL	MIL		NONE		~ ()~~~In patient		1						1	Guillain-Barre syndrome; Hypokinesia; Laboratory test abnormal	FLU3~PFIZER\WYETH~4948202~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0071202	02/01/1995	GA	26.0			M	01/18/1995	pt recvd vax & 2-3 days a/development of sx & findings of GBS sx progressed resulting in resp failure requiring ongoing mech ventilation;			Y		Y				U				sx & findings compatable w/GBS	MIL	MIL		NONE	pre-ceeding viral URI	NA~ ()~~~In patient		1						1	Apnoea; Guillain-Barre syndrome	FLU3~PFIZER\WYETH~4948202~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0071204	02/01/1995	MA	49.0	49		F	01/26/1995	on arising had difficulty speaking, h/a, numb rt arm & leg w/pins & needles sensation in hop; had IV Solumedrol & Pred taper-little improvement;				Y	Y	16		Y	N	11/04/1994	11/28/1994	24	MRI of head-multiple brian lesions; brian biopsy showed demyelinating disease-multiple sclerosis-many test in hosp;	PVT	UNK	Theo-24, aldactone, Captopril, Premarin, Alupent & Beclovelt inhaler	NONE	asthma-HTN-hyperaldosteronis	~ ()~~~In patient		1						1	Delirium; Dementia; Headache; Laboratory test abnormal; Multiple sclerosis; Neuropathy; Paraesthesia; Speech disorder	FLU3~PFIZER\WYETH~4948104~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0071109	02/02/1995	NJ	64.0	64		F	01/29/1995	pt recvd vax; severe pain extending base of neck to base of spine;1jan95 unable to walk more than 2 steps;cat scan for arthritis flare up;adm to hosp 4jan95;ICU as 5% lymes, 95% GBS; now in rehab hosp;					Y	16	Y		N	10/31/1994	12/30/1994	60	CAT scans, blood tests,spinal fluid tests;EMG, EEG, EKG,X-ray;	OTH	OTH	vasotec	none	hypertension & arythmea	~ ()~~~In patient		1						2	Asthenia; Back pain; Eyelid ptosis; Guillain-Barre syndrome; Hypotonia; Pharyngitis; Rhinitis; Arthritis; Asthenia; Guillain-Barre syndrome; Hypokinesia; Neck pain	FLU3~CONNAUGHT LABORATORIES~4F51067~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~4H51067~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0071231	02/03/1995	KS	54.0	54		F	10/24/1994	pt recvd vax; lt arm red & swollen from elbow to deltoid; tender to touch; still swollen x 72 hrs but dec;				Y					Y	10/21/1994	10/22/1994	1	allergy testing hosp	PUB	PUB		none	none	~ ()~~~In patient	KS94049	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4948130~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1474W~1~IM L~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0071233	02/03/1995	KS	63.0	63		M	11/18/1994	pt recvd vax; 1 wk began having cough;2 wks later cough  much worse;saw MD,dx: bacterial bronchial infect & prescribed ATBs;				Y					Y	11/01/1994	11/07/1994	6	none	OTH	PVT	none	none	wegeners granulomatosis;	~ ()~~~In patient	KS94051	1						1	Bronchitis; Cough; Infection	FLU3~CONNAUGHT LABORATORIES~4F51132~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0071238	02/03/1995	KS	48.0	48		M	12/09/1994	pt recvd vax; pt reports some sxs next day w/ heaviness to rt arm;fine 5nov94;woke up 6nov94 feeling bad;needed to go to hosp;have had 13,000 WBC & system shut down;				Y	Y	1			Y	11/03/1994	11/06/1994	3		PUB	UNK		none per pt	asthma	~ ()~~~In patient	KS94057	1						1	Leukocytosis; Malaise; Myasthenic syndrome	FLU3~PARKE-DAVIS~00574P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~1474W~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0071252	02/03/1995	NV	66.0	66		F	01/11/1995	pt recvd vax; burning in esophogus, n, chills; t 91.5; general aches, d,states anything she eats causes burning sensation; MD called;										01/09/1995	01/09/1995	0		UNK	UNK	pamagepan, premarin, zanax, synthroid	none	stress	~ ()~~~In patient	NV95002	1						1	Chills; Diarrhoea; Hypothermia; Myalgia; Nausea; Oesophagitis	FLU3~PFIZER\WYETH~4948119~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0071272	02/03/1995	CO	57.0	57		M	12/05/1994	pt recvd vax in the AM & reportedly devel fever that evening; was admitted to hosp during the next week & died exactly 1 wk from the vax date reportedly of a bacterial infect in blood;	Y	10/26/1994		Y	Y	6			N	10/19/1994	10/19/1994	0		OTH	OTH		Feeling slightly ill;	No spleen; hx of asthma, hx of positive HIV test; hypertension; gout;	~ ()~~~In patient		1						1	Blood creatinine increased; Blood fibrinogen decreased; Blood urea increased; Coagulopathy; Hypotension; Infection; Leukocytosis; Sepsis	FLU3~PARKE-DAVIS~01764P~1~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0071282	02/03/1995	NY	40.0	39		F	01/27/1995	pain, swelling of arm shoulder &  elbow & inc temp; tenderness lt shoulder & elbow; fever of 102 on 25JAN95 & all day 26JAN95;										01/25/1995	01/25/1995	0		PUB	PUB	Spironolactone, Lasix, Multivitamin	cirrhosis w/hepatosplenomegaly & br asth	bronchial asthma & cirrhosis w/hepatosplenomegaly	~ ()~~~In patient		1						1	Arthralgia; Oedema; Oedema peripheral; Osteoarthritis; Pain; Pyrexia	FLU3~PFIZER\WYETH~4948125~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~384961~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0071285	02/03/1995	MA				F	01/19/1995	10x20 cm area of swelling & erythema & soreness in region of inject (reported 19JAN95 by parent);									Y	10/11/1994	10/12/1994	1	NONE	PVT	UNK		NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~4F51025~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0072173	02/03/1995	MO	46.0	46		M	11/11/1994	pt recvd vax;next year in apr94 pt was dx w/ amyotrophic lateral sclerosis;			Y	Y				Y	N	10/12/1993	04/01/1994	171		PUB	PUB	none	none	none		894320002K	1						1	Muscle atrophy; Neuropathy	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Disabling	Influenza
0072174	02/03/1995	OH	66.0	66		F	11/04/1994	pt recvd vax;next 14-15 days devel lymphadenopathy;the adenopathy resolved a/ biopsy could be performed;redness & tenderness at inj site;pt had similar rxn to the 94-95 formula;				Y					Y	10/19/1994	10/20/1994	1		OTH	OTH				pt had similar rxn to the 94-95 formula;~ ()~~~In patient	894333005S	1						1	Injection site hypersensitivity; Injection site pain; Lymphadenopathy; Vasodilatation	FLUX~PFIZER\WYETH~4948118~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0072175	02/03/1995	FL	59.0	59		M	12/21/1994	pt recvd vax;subsequently devel neurological impairment;								Y	N	11/22/1993	12/08/1993	16		PVT	PVT	Metamucil l tsp in 8 oz of water	unk	duodenal ulcer and hiatal hernia at age 16, esophagitis with deformed bulb, slightly bulging annulus at L4-5, gastroesophageal reflux , vertigo	~ ()~~~In patient	894356006Z	1						1	Arthralgia; Encephalitis; Eye pain; Myelitis; Neuropathy; Pyrexia; Urinary tract infection; Visual disturbance	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0072196	02/03/1995	NJ				M	10/04/1994	pt recvd vax NOV93 & 2 to 3 months later devel arthritic type problems characterized by fatigue, muscle pain, & joint pain; pt was treated w/Relafen, Lodine & diclofenac; pt reports that pain started to subside as of JUL94;				Y					N	11/01/1993				OTH	OTH	unk	unk		~ ()~~~In patient	894286001A	1						1	Arthralgia; Arthritis; Asthenia; Myalgia	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0072197	02/03/1995	IN	38.0			F	10/17/1994	pt recvd vax & devel burning, redness, & swelling @ inj site which lasted for a couple of days & required ice; also devel h/a, nausea, upset stomach, & cold; had to stay in bed 3-4 days due to symptoms & couldn't use arm;									Y					PUB	OTH	unk	NONE	pt is allergic to thimerosal, & has had rxn to eye products preserved w/thimerosal	~ ()~~~In patient	894297001K	1						1	Dyspepsia; Headache; Hypokinesia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pharyngitis; Rhinitis	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0072198	02/03/1995	IL	27.0	27		F	10/18/1994	pt recvd vax & a few hrs later exp pain & redness @ inject site; 1 day later exp swelling & warmth @ the inject site; sx persisted for approx 2 wks;									Y	10/01/1993	10/01/1993	0		PUB	PUB	ASA, Keflex	NONE	pt had no react to flu vax 94-95 formula	NONE~ ()~~~In patient	894297002K	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLUX~PFIZER\WYETH~4938192~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0072199	02/03/1995	PA	7.0	7		F	10/17/1994	pt recvd vax & 2 days later pt's arm devel edema from elbow to shoulder;									Y	10/28/1993	10/30/1993	2		PVT	PVT	unk	NONE	pt has asthma	~ ()~~~In patient	894298002K	1						1	Oedema peripheral	FLUX~PFIZER\WYETH~~5~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0072200	02/03/1995	KS	65.0	64		F	10/25/1994	pt recvd vax & 1 1/2 hrs later pt noted lt earlobe becoming itchy; 3 hrs p/inj noted a rash on lt earlobe & on a small area below the ear; no tx was sought; rash resolved w/in 1 day									Y	10/19/1993	10/19/1993	0		PVT	PVT	Tamoxifen, Pepsid, Reglan, Tenormin	NONE	pt has a hx of breast CA, irregular heart beat, & digestive DO; pt is allergic to sulfites, PCN & ASA	~ ()~~~In patient	894304001K	1						1	Pruritus; Rash	FLUX~PFIZER\WYETH~4938217~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0058025	02/06/1995	MI				F	01/13/1995	pt recvd vax;dx w/ GBS,chronic polyneuropathy;also weakness,inability to use hands,motor functioning impairment,dyspnea,dec tolerance to illness of any kind;emotional/physical pain/suffering;may be permanent nature;serious adverse event;								Y	N	12/05/1991			none	PUB	PUB				~ ()~~~In patient	895017004Z	1						2	Asthenia; Dyspnoea; Gait disturbance; Guillain-Barre syndrome; Hypokinesia; Immune system disorder; Neuropathy; Pain	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Disabling	Influenza
0069634	02/06/1995	OH	64.0	64		M	01/17/1995	pt recvd vax;devel diffuse rash & fever;adm to hosp 21oct w/fever & pancytopenia (WBC=0,platelets=60,000);tx w/ ATBs,recovered					Y	10				10/12/1994	10/18/1994	6	bone marrow biopsies 24oct,7nov;CBC nl as of 17nov; no viral culture done;	PVT	PVT	antihypertensives;		mild chronic renal failure from hypertension;hx of agranulocytosis ;	none~ ()~~~In patient	895017006Z	1						2	Leukopenia; Pancytopenia; Pyrexia; Rash; Thrombocytopenia	FLU3~PFIZER\WYETH~4948118~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~384959~UNK~IM~RA~PNEUMO (PNU-IMUNE)~2	USA	Hospitalisation	Influenza
0071300	02/06/1995	IL	58.0	58		M	02/02/1995	pt recvd vax;w/in a couple of days,difficulty walking,stiffness in ankles,numbness in feet;forearms painful;generally felt sick;called MD who felt mild rxn to vax;tests done, all neg;x-ray neg;referred to neurologist;pt better,coughing less				Y					N	10/16/1994	10/18/1994	2		OTH	OTH	none			in pt, previous flu shot w/ some weakness afterwards but nothing serious~ ()~~~In patient	CO5808	1						1	Arthropathy; Gait disturbance; Malaise; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51023~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0071303	02/06/1995	TX	7.0	7		M	01/11/1995	pt recvd vax;next day,began chest pain & muscle pain'w/in hrs muscle pain progressed upward & downward until exp muscle weakness;was adm to hosp & tx w/ IV corticosteroids & ibuprofen for pain;discharged 10jan;improving;					Y	5			U	01/04/1995	01/06/1995	2		PUB	PVT			hx of asthma	~ ()~~~In patient	895012006Z	1						1	Chest pain; Hyporeflexia; Myalgia; Myasthenic syndrome; Myositis; Pain; Paralysis; Sepsis	FLU3~PFIZER\WYETH~4948038~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0071310	02/06/1995	AR	40.0	40		F	12/15/1994	pt recvd vax;30 mins later,had sz;arms & legs shaking,body/head moving;face pale;c/o feeling funny & dizzy;BP 180/70;P=104;denies taking any meds;ice bag applied to back of neck due to c/o feeling hot;pt feeling better;P-98;				Y					Y	11/03/1994	11/03/1994	0	none	PUB	PUB	none	none	none	none~ ()~~~In patient	AR957	1						1	Convulsion; Dizziness; Hypertension; Pallor; Tachycardia; Tremor; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51087~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0067241	02/07/1995	IL	28.0	28		F	10/06/1994	pt recvd vax 28SEP94 & devel a rash on 30SEP94; also had nausea & a h/a; 3OCT94 devel hives;									U	09/28/1994	09/30/1994	2		PVT	PVT	Desogen	NONE		~ ()~~~In patient	894287005L	1						2	Headache; Nausea; Rash; Urticaria	FLU3~PFIZER\WYETH~4948048~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0067574	02/07/1995	DE	76.0	76		F	10/13/1994	pt recvd vax & 3 mins later became lightheaded, devel nausea & vomiting which persisted for 4 hrs; pt was given DPH; EKG was stable lt bundle branch block), pulse was 80 bpm & pt appeared pale; BP 142/75; felt washed out; nystagmus;				Y					N	09/02/1994	09/22/1994	20	22SEP94 EKG nl	OTH	OTH	unk	unk		~ ()~~~In patient	894350001S	1						2	Bundle branch block; Dizziness; Gait disturbance; Hypertension; Nausea; Nystagmus; Pallor; Vomiting	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0067874	02/07/1995	NM	48.0	48		F	10/28/1994	pt recvd vax; almost immed p/vax,pt devel swelling, redness & a maculopapular rash over a 3 inch area at inject site;pt tx w/ po dph & sxs began to abate;									U	10/24/1994	10/24/1994	0		PUB	OTH	none	none	possible gentamycin allergy	~ ()~~~In patient	894311001K	1						3	Injection site hypersensitivity; Injection site oedema; Rash maculo-papular	FLU3~PFIZER\WYETH~4948131~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~3	USA		Influenza
0068433	02/07/1995	CA	43.0	43		F	01/30/1995	dizziness, aches, headaches, vomiting;					Y	12			N	10/21/1994	10/26/1994	5		PVT	UNK				~ ()~~~In patient		1						2	Dizziness; Headache; Myalgia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0068551	02/07/1995	NC	26.0	26		F	10/26/1994	pt recvd vax & 1wk later devel a neuropathy characterized by numbness in the digits & lower extremities, brachial plexopathy & bilateral involvement of the long thoracic nerves				Y					N	10/03/1994	10/13/1994	10		PVT	PVT	NONE	NONE		~ ()~~~In patient	894305007K	1						2	CSF test abnormal; Hypokinesia; Hyporeflexia; Myasthenic syndrome; Neuropathy; Paraesthesia	FLU3~PFIZER\WYETH~4948106~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0069015	02/07/1995	CO	58.0	58		F	11/22/1994	pt recvd vax & approx 6 days later devel a localized rash & swelling of the hand (to the wrists), lower trunk, & lower extremities; pt was treated w/hot compresses & topical hydrocortisone;				Y					Y	10/22/1994	10/28/1994	6		OTH	PVT	none	none	allergies to amoxicillin, sulfa, indocin	~ ()~~~In patient	894346006S	1						3	Oedema; Oedema peripheral; Rash	FLU3~PFIZER\WYETH~4948145~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~3	USA	Emergency room visit	Influenza
0070625	02/07/1995	NY				F	12/19/1994	pt recvd vax 7OCT94 & thereafter devel noises in the head described as hissing & ringing; these have affected sleep; pt was examined by family MD, ear specialist, & a neurologist who were unable to give a dx;				Y					N	10/07/1994	10/08/1994	1	MRI scan-neg; Blood work (unspecified)- neg	OTH	OTH	unk	unk		~ ()~~~In patient	894364001S	1						2	Insomnia; Tinnitus; Insomnia; Sleep disorder; Tinnitus	FLU3~PARKE-DAVIS~00474P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0070637	02/07/1995	NY				M	12/19/1994	pt recvd vax 7OCT94 & shortly thereafter devel noises in head described as hissing & ringing; these have affected pt's sleep; pt was examined by family MD, ear specialist & neurologist who were unable to give a dx;				Y					N	10/07/1994	10/08/1994	1	CAT Scan-neg; Blood work (unspecified)-neg;	OTH	OTH	unk	unk		~ ()~~~In patient	894364002S	1						2	Headache; Tinnitus; Insomnia; Sleep disorder; Tinnitus	FLU3~PARKE-DAVIS~00474P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0071354	02/07/1995	MA	45.0	45		F	02/03/1995	upper arm aching & weak; cannot lift as much as usual in certain positions; It still hurts three months p/shot;									N	10/29/1994	11/03/1994	5		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MA9502	1						1	Hypokinesia; Myalgia; Myasthenic syndrome; Pain	FLU3~CONNAUGHT LABORATORIES~4F51016~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0071362	02/07/1995	OH	45.0	45		F	01/27/1995	onset of severe abdo cramping/diarrhea (approx 2-4 stool) w/nausea but no vomiting which started 10-12 hrs p/flu vax & stopped 12-15 hrs later;									Y	11/03/1994	11/04/1994	1	NONE	UNK	UNK	Inderal, BCP	NONE	NKA/Inderal Cardiac	NONE~ ()~~~In patient		1						1	Abdominal pain; Diarrhoea; Nausea; Vomiting	FLU3~PFIZER\WYETH~4948038~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072201	02/07/1995	VA	38.0	38		M	11/07/1994	pt recvd vax & 20 to 30 mins later devel angioedema & anaphylaxis characterized by tachycardia, urticaria of the neck & face, an elevated BP, swelling & redness of the buccal mucosa, pruritus, bilateral wheezing & apprehension; tx DPH & Epi			Y						Y	10/31/1994	10/31/1994	0		PVT	PVT	unk	NONE	pt may have a hx of an allergic rxn to thimerosal in contact lens solution	~ ()~~~In patient	894318003K	1						1	Anaphylactoid reaction; Angioneurotic oedema; Anxiety; Asthma; Hypertension; Pruritus; Tachycardia; Urticaria	FLU3~PFIZER\WYETH~4948047~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening	Influenza
0072202	02/07/1995	PA				U	12/23/1994	pt recvd vax & the following morning had an allergic rxn, characterized by swollen eyes & difficulty breathing; pt was treated w/DPH & Proventil inhaler;			Y	Y					U	10/06/1994	10/06/1994	0		PVT	PVT	unk	unk		~ ()~~~In patient	895003004S	1						1	Dyspnoea; Face oedema; Hypersensitivity	FLU3~PFIZER\WYETH~4948075~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening	Influenza
0072204	02/07/1995	IL	49.0	49		F	10/12/1994	pt recvd vax 5OCT94 & 15 mins later devel a half-dollar sized raised area by collarbone; also c/o aching in the arm pit; On 12OCT94 stated that whole arm ached; sx resolved in 4-5 days;									Y	10/05/1994	10/05/1994	0		OTH	OTH	anticoagulants	NONE	NONE	~ ()~~~In patient	894287006L	1						1	Myalgia; Skin nodule	FLU3~PFIZER\WYETH~4948128~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072205	02/07/1995	CA	76.0	76		F	10/10/1994	pt recvd vaax 4OCT94 & the next day exp facial flushing, temp elevation to 99.6, chills, weakness & swelling in the rt axilla & in both groins;									Y	10/04/1994	10/05/1994	1		PVT	OTH	ASA, Cardizen, Premarin	NONE		~ ()~~~In patient	894287007L	1						1	Asthenia; Chills; Oedema; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4948118~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072206	02/07/1995	FL	52.0			F	10/07/1994	pt recvd vax 6OCT94 & 15 mins later devel itching all over body, redness @ the inj site & SOB; pt was treated w/DPH & w/in 1 hr all sx had resolved;				Y					Y	10/06/1994	10/06/1994	0		PVT	PVT	Premarin	NONE	NONE	~ ()~~~In patient	894287008L	1						1	Dyspnoea; Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~4948038~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072207	02/07/1995	MO				U	10/06/1994	pt exp flu-like sx coincident w/administration of flu inj; sx began approx 1 to 2 days p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	894290001K	1						1	Influenza	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072208	02/07/1995	MO				U	10/06/1994	pt exp flu-like sx coincident w/the administrtion of the flu inj; these sx began approx 1 to 2 days p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	894290002K	1						1	Influenza	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072209	02/07/1995	MO				U	10/06/1994	pt exp flu-like sx coincident w/the administration of flu inj; these sx began approx 1 to 2 days p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	894290003K	1						1	Influenza	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072210	02/07/1995	MO				U	10/06/1994	pt exp flu-like sx coincident w/administration of flu inj; these sx began approx 1 to 2 days p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	894290004K	1						1	Influenza	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072211	02/07/1995	OH	65.0	65		F	10/13/1994	pt recvd vax & devel redness, soreness & warmth @ the inj site; pt was also nauseated;									Y	10/12/1994	10/13/1994	1		PVT	PVT	NONE	NONE		~ ()~~~In patient	894291001K	1						1	Injection site hypersensitivity; Injection site pain; Nausea; Vasodilatation	FLU3~PFIZER\WYETH~4948100~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072212	02/07/1995	OH	52.0	52		F		pt recvd flu vax & devel edema, erythema, pruritus @ inj site;									Y	10/27/1994	10/28/1994	1		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	894291002K	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4948053~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072213	02/07/1995	AL	34.0	34		F	10/12/1994	pt recvd vax & devel swelling, redness & tenderness @ inj site;									U	10/10/1994	10/10/1994	0		PUB	PUB	unk	NONE		~ ()~~~In patient	894291003K	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072214	02/07/1995	NH	79.0	79		M	10/14/1994	pt recvd vax & devel generalized hives & periorbital edema; pt was treated w/SC Epi, DPH & Pred; hives abated completely p/5 days;				Y					Y	10/12/1994	10/13/1994	1		PUB	PVT	ASA	NONE	NONE	~ ()~~~In patient	894291004K	1						1	Face oedema; Urticaria	FLU3~PFIZER\WYETH~4948124~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072215	02/07/1995	GA	22.0	22		F	10/13/1994	pt recvd vax;20 mins later devel neck stiffness & severe HA;also devel petechiae under rt eye & pallor;vital signs nl;to er;MD felt had an allergic rxn; discharged w/o tx;				Y					N	10/13/1994	10/13/1994	0		PVT	OTH		none	none	~ ()~~~In patient	894291005K	1						1	Headache; Hypersensitivity; Nuchal rigidity; Pallor; Petechiae	FLU3~PFIZER\WYETH~4948116~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072216	02/07/1995	CA				U	10/13/1994	pt recvd vax; pt devel redness & swelling at inject site;ice applied to rxn site & all sxs resolved w/o sequelae;									Y					PVT	PVT		none	none	~ ()~~~In patient	894292002K	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4948101~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072217	02/07/1995	CA				U	10/13/1994	pt recvd vax; devel redness & swelling at inj site;ice applied to site & all sxs resolved;									Y					PVT	PVT		none	none	~ ()~~~In patient	894292003K	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4948101~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072218	02/07/1995	CA				U	10/13/1994	pt recvd vax; devel redness & swelling at inject site; Ice applied to rxn site & all sxs resolved;									Y					PVT	PVT			none	none~ ()~~~In patient	894292004K	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4948101~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072219	02/07/1995	CA				U	10/13/1994	pt recvd vax; devel redness & swelling at inject site; Ice applied at rxn site & all sxs resolved;									Y					PVT	PVT			none	~ ()~~~In patient	894292005K	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4948101~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072220	02/07/1995	AR				U	10/03/1994	pt recvd vax; devel redness & swelling at inject site, & a knot below the inject site;									U					PVT	OTH			none	~ ()~~~In patient	894294001K	1						1	Injection site inflammation; Injection site mass	FLU3~PFIZER\WYETH~4948105~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072221	02/07/1995	AR				U	10/03/1994	pt recvd vax;12-24 hrs later, devel inflam at inj site, & a knot below the inj site;									U					PVT	OTH			none	~ ()~~~In patient	894294002K	1						1	Injection site inflammation; Injection site mass	FLU3~PFIZER\WYETH~4948105~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072222	02/07/1995	AR				U	10/03/1994	pt recvd vax; w/in 12-24 hrs, devel inflam at inject site, and a knot below inject site;									U					PVT	OTH			none	none~ ()~~~In patient	894294003K	1						1	Injection site inflammation; Injection site mass	FLU3~PFIZER\WYETH~4948105~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072223	02/07/1995	AR				U	10/03/1994	pt recvd vax;w/in 12-24hrs pt devel inflam at inject site, & a knot below the inject site;									U					PVT	OTH				none~ ()~~~In patient	894294004K	1						1	Injection site inflammation; Injection site mass	FLU3~PFIZER\WYETH~4948105~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072224	02/07/1995	AR				U	10/03/1994	pt recvd vax; w/in 12-24 hrs devel iflam at inj site & a knot below inj site;									U					PVT	OTH			none	none~ ()~~~In patient	894294005K	1						1	Injection site inflammation; Injection site mass	FLU3~PFIZER\WYETH~4948105~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072225	02/07/1995	AR				U	10/03/1994	pt recvd vax;w/in 12-24 hrs, devel inflam at inject site & a knot below inj site;									U	10/03/1994				PVT	OTH				none~ ()~~~In patient	894294006K	1						1	Injection site inflammation; Injection site mass	FLU3~PFIZER\WYETH~4948105~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072226	02/07/1995	AR				U	10/03/1994	pt recvd vax; w/in 12-24 hrs devel inflam at inject site & a knot below inject site									U					PVT	OTH				~ ()~~~In patient	894294007K	1						1	Injection site inflammation; Injection site mass	FLU3~PFIZER\WYETH~4948105~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072227	02/07/1995	AR				U	10/03/1994	pt recvd vax;w/in 12-24 hrs later, pt devel inflam at inject site & a knot below inject site;									U					PVT	OTH			none	none~ ()~~~In patient	894294008K	1						1	Injection site inflammation; Injection site mass	FLU3~PFIZER\WYETH~4948105~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072228	02/07/1995	LA	42.0	42		M	10/18/1994	pt recvd vax;1 day later, exp edema,redness & warmth at inj site;									Y	10/12/1994	10/13/1994	1		PVT	PVT	valium	none	none	none~ ()~~~In patient	894294009K	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948117~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072229	02/07/1995	LA	26.0	26		M	10/18/1994	pt recvd vax; exp fever, chills & n;									Y	10/13/1994	10/13/1994	0		PVT	PVT		cold	none	~ ()~~~In patient	894294010K	1						1	Chills; Nausea; Pyrexia	FLU3~PFIZER\WYETH~4948117~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072230	02/07/1995	LA	52.0	52		F	10/18/1994	pt recvd vax;exp ringing in ears & edema & pain at inject site;									N	10/14/1994	10/15/1994	1		PVT	PVT	prematin,provera,synthroid;	none	none	~ ()~~~In patient	894294011K	1						1	Injection site oedema; Injection site pain; Tinnitus	FLU3~PFIZER\WYETH~4948117~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072231	02/07/1995	MD	58.0	58		M	10/04/1994	pt recvd vax;1 day later,presented w/ edema, redness, warmth & pain at inj site;				Y					N	10/04/1994	10/04/1994	0		PVT	PVT	procardia, lopressor	none	none	~ ()~~~In patient	894297003K	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4948056~4~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072232	02/07/1995	NM				U	10/14/1994	pt recvd vax & exp unspecified rxn;									U	10/12/1994				OTH	OTH			none	~ ()~~~In patient	894297004K	1						1	Unevaluable event	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072233	02/07/1995	TX	40.0	40		F	10/17/1994	pt recvd vax;next day exp pain of skin on rt,lower anterior chest,& a bruise on rt arm;MD made a dx of shingles & pt was tx w/2 courses of Zovirax;				Y					Y	10/05/1994	10/06/1994	1		PVT	OTH		none	none	none~ ()~~~In patient	894297005K	1						1	Chest pain; Ecchymosis; Herpes zoster	FLU3~PFIZER\WYETH~4948051~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072234	02/07/1995	CA				U	10/06/1994	pt recvd vax; 1 day later, pt exp inj site rxn characterized by redness & warmth;									U	10/03/1994	10/04/1994	1		PUB	OTH			none	~ ()~~~In patient	894297006K	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PFIZER\WYETH~4948031~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072235	02/07/1995	NC	44.0	44		F	10/19/1994	pt recvd vax;w/in mins,exp diff walking,weakness & SOB;c/o numbness of tongue & fingertips,became stuporous & difficult to arouse;shaking & chills;O2 adm, observed in er;devel periorbital edema;final dx:allergic rxn;discharged on po dph				Y					U	10/18/1994	10/18/1994	0	VitP = 100 BPM; R 24/min; BP = 160/90mmHg & 154/88mmHg; Blood sugar nl;	PUB	OTH	none	none	none	~ ()~~~In patient	894297007K	1						1	Asthenia; Dyspnoea; Face oedema; Hypersensitivity; Hypertension; Hypokinesia; Paraesthesia; Stupor	FLU3~PFIZER\WYETH~4948105~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072236	02/07/1995	IN	54.0	54		F	10/19/1994	pt recvd vax;later on same day, exp facial flushing,facial rash & tightness in the throat;				Y					N	10/17/1994	10/17/1994	0		PVT	OTH	tenormin	none	hx of rxn for a stress thallium test;allergic to propylene glycol;	none~ ()~~~In patient	894297008K	1						1	Laryngospasm; Rash; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072237	02/07/1995	IA	59.0	59		F	10/18/1994	pt recvd vax;1 day later,c/o HA,scratchy throat, & feeling warm which persisted til 16oct94;17oct94,exp a heaviness in chest & had a weak voice;									N	10/03/1994	10/04/1994	1		PUB	OTH		none	hx of similar rxn to vax the previous yrs;	in pt, similar rxn to vax during previous yrs;~ ()~~~In patient	894298001K	1						1	Chest pain; Dysphonia; Headache; Pharyngitis; Pyrexia	FLU3~PFIZER\WYETH~4948037~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072238	02/07/1995	MA				U	10/19/1994	pt recvd vax;devel a sore warm area at inject site;									U	10/01/1994	10/01/1994	0		PVT	OTH			none	~ ()~~~In patient	894298004K	1						1	Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4948055~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072239	02/07/1995	MA				U	10/19/1994	pt recvd vax; devel a sore, warm area at the inject site;									U	10/01/1994	10/01/1994	0		PVT	OTH			none	~ ()~~~In patient	894298005K	1						1	Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4948055~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072240	02/07/1995	MA				U	10/10/1994	pt recvd vax;devel a sore, warm area at inject site;									U	10/01/1994	10/01/1994	0		PVT	OTH			none	~ ()~~~In patient	894298006K	1						1	Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4948055~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072241	02/07/1995	MA				U	10/19/1994	pt recvd vax; devel a sore, warm area at inject site;									U	10/01/1994	10/01/1994	0		PVT	OTH			none	~ ()~~~In patient	894298007K	1						1	Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4948055~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072242	02/07/1995	MA				U	10/19/1994	pt recvd vax; devel a sore, warm area at inject site;									U	10/01/1994	10/01/1994	0		PVT	OTH			none	~ ()~~~In patient	894298008K	1						1	Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4948055~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072243	02/07/1995	OH	52.0	52		F	10/20/1994	pt recvd vax;devel a hard,red,swollen area at inject site; cellulitis was dx;pt tx w/ Kef tabs BID for 2 days;recovered w/in 3 days;									Y	10/10/1994	10/10/1994	0		PVT	PVT	none	none	none	~ ()~~~In patient	894299002K	1						1	Cellulitis; Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~PFIZER\WYETH~4948100~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072244	02/07/1995	KY	39.0	39		F	10/20/1994	pt recvd vax;exp redness,soreness & edema around inject site;persisted x 3 days;rash also devel on trunk;exp also sore muscles/joints for almost 5 days;pt recovered fully as of 20oct94;									Y	10/14/1994	10/14/1994	0		PVT	PVT	none	none	none	~ ()~~~In patient	894299004K	1						1	Arthralgia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4948127~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072245	02/07/1995	KY	39.0	39		F	10/20/1994	pt recvd vax;immed p/vax,area around inject site became red,hot,hard & swollen;devel pruritus at inject site & felt n & dizzy;was tx w/ dph & ice pack to site;									Y	10/18/1994	10/18/1994	0		PUB	PVT	premarin,unspecified BP med;	none	none	~ ()~~~In patient	894300001K	1						1	Dizziness; Injection site hypersensitivity; Injection site mass; Injection site oedema; Nausea; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4948127~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072246	02/07/1995	KY	40.0	40		F	10/20/1994	pt recvd vax;1 day later,devel tender,redness & induration around inject site;tx w/ dph;									Y	10/18/1994	10/19/1994	1		PVT	PVT	premarin	none	none	~ ()~~~In patient	894300002K	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~PFIZER\WYETH~4948127~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072247	02/07/1995	PA				U	10/20/1994	pt recvd vax;w/in several hrs, devel redness, induration,swelling & warmth at inject site;									U	10/18/1994	10/18/1994	0		PVT	OTH			none	~ ()~~~In patient	894300003K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948112~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072248	02/07/1995	PA				U	10/20/1994	pt recvd vax; w/in 24 hrs, devel redness, induration, swelling & warmth at site of inject;									U	10/18/1994	10/19/1994	1		PVT	OTH			none	~ ()~~~In patient	894300004K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948112~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072249	02/07/1995	PA				U	10/20/1994	pt recvd vax 18OCT94 & w/in 24 hrs pt devel redness, induration, swelling, & warmth @ the site of inj;									U	10/18/1994	10/19/1994	1		PVT	OTH	unk	unk		~ ()~~~In patient	894301001K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948112~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072250	02/07/1995	PA				U	10/20/1994	pt recvd vax 18OCT94 & w/in 24 hrs pt devel redness, induration, swelling & warmth @ the site of inj;									U	10/18/1994	10/19/1994	1		PVT	OTH	unk	unk		~ ()~~~In patient	894301002K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948112~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072251	02/07/1995	PA				U	10/20/1994	pt recvd vax & w/in 24 hrs pt devel redness, induration, swelling, & warmth @ the site of inj;									U	10/18/1994	10/19/1994	1		PVT	OTH	unk	unk		~ ()~~~In patient	894301003K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948112~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072252	02/07/1995	PA				U	10/20/1994	pt recvd vax & w/in 24 hrs pt devel redness, induration, swelling & warmth @ the site of inj;									U	10/18/1994	10/19/1994	1		PVT	OTH	unk	unk		~ ()~~~In patient	894301004K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948112~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072253	02/07/1995	PA				U	10/20/1994	pt recvd vax & w/in 24 hrs pt devel redness, induration, swelling, & warmth @ the site of inj;									U	10/18/1994	10/19/1994	1		PVT	OTH	unk	unk		~ ()~~~In patient	894301005K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948112~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072254	02/07/1995	PA				U	10/20/1994	pt recvd vax & w/in 24 hrs pt devel redness, induration, swelling, & warmth @ the site of inj;									U	10/18/1994	10/19/1994	1		PVT	OTH	unk	unk		~ ()~~~In patient	894301006K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948112~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072255	02/07/1995	PA				U	10/20/1994	pt recvd vax & w/in 24 hrs pt devel redness, induration, swelling, & warmth @ the site of inj;									U	10/18/1994	10/19/1994	1		PVT	OTH	unk	unk		~ ()~~~In patient	894301007K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948112~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072256	02/07/1995	PA				U	10/20/1994	pt recvd vax & w/in 24 hrs, pt devel redness, induration, swelling, & warmth @ the site of inj;									U	10/18/1994	10/19/1994	1		PVT	OTH	unk	unk		~ ()~~~In patient	894301008K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948112~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072257	02/07/1995	PA				U	10/20/1994	pt recvd vax & w/in 24 hrs pt devel redness, induration, swelling, & warmth @ the site of inj;									U	10/18/1994	10/19/1994	1		PVT	OTH	unk	unk		~ ()~~~In patient	894301009K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948112~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072258	02/07/1995	PA				U	10/20/1994	pt recvd vax & w/in 24 hrs pt devel redness, induration, swelling, & warmth @ the site of inj;									U	10/18/1994	10/19/1994	1		PVT	OTH	unk	unk		~ ()~~~In patient	894301010K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948112~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072259	02/07/1995	PA				U	10/20/1994	pt recvd vax & w/in 24 hrs pt devel redness, induration, swelling, & warmth @ the site of inj;									U	10/18/1994	10/19/1994	1		PVT	OTH	unk	unk		~ ()~~~In patient	894301011K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948112~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072260	02/07/1995	PA				U	10/20/1994	pt recvd vax & w/in 24 hrs pt devel redness, induration, swelling & warmth @ the site of inj;									U	10/18/1994	10/19/1994	1		PVT	OTH	unk	unk		~ ()~~~In patient	894301012K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948112~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072261	02/07/1995	PA				U	10/20/1994	pt recvd vax & w/in 24 hrs pt devel redness, induration, swelling, & warmth @ the site of inj;									U	10/18/1994	10/19/1994	1		PVT	OTH	unk	unk		~ ()~~~In patient	894301013K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948112~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072262	02/07/1995	PA				U	10/20/1994	pt recvd vax & w/in 24 hrs pt devel redness, induration, swelling, & warmth @ the site of inj;									U	10/18/1994	10/19/1994	1		PVT	OTH	unk	unk	unk	~ ()~~~In patient	894301014K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948112~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072263	02/07/1995	PA				U	10/20/1994	pt recvd vax & w/in 24 hrs pt devel redness, induration, swelling & warmth @ site of inj;									U	10/18/1994	10/19/1994	1		PVT	OTH	unk	unk		~ ()~~~In patient	894301015K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948112~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072264	02/07/1995	PA				U	10/20/1994	pt recvd vax & w/in 24 hrs pt devel redness, induration, swelling, & warmth @ the site of inj;									U	10/18/1994	10/19/1994	1		PVT	OTH	unk	unk		~ ()~~~In patient	894301016K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948112~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072265	02/07/1995	PA				U	10/20/1994	pt recvd vax & w/in 24 hrs pt devel redness, induration, swelling & warmth @ the site of inj;									U	10/18/1994	10/19/1994	1		PVT	OTH	unk	unk		~ ()~~~In patient	894301017K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948112~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072266	02/07/1995	PA				U	10/20/1994	pt recvd vax & w/in 24 hrs pt devel redness, induration, swelling, & warmth @ the site of inj;									Y	10/18/1994	10/19/1994	1		PVT	OTH	unk	unk		~ ()~~~In patient	894301018K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948112~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072267	02/07/1995	PA				U	10/20/1994	pt recvd vax & w/in 24 hrs pt devel redness, induration, swelling, & warmth @ site of inj;									U	10/18/1994	10/19/1994	1		PVT	OTH	unk	unk		~ ()~~~In patient	894301019K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948112~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072268	02/07/1995	PA	25.0	25		F	10/27/1994	pt recvd vax & w/in 24 hrs pt devel red welt, pain, bruising, & warmth @ the inj site;				Y					Y	10/24/1994	10/25/1994	1		PVT	OTH	Zoloft, Nasacort, Vicon Forte, Tavist-D, Levlen	NONE	pt has a hx of depression & seasonal allergies;	~ ()~~~In patient	894305001K	1						1	Ecchymosis; Pain; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4948144~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072269	02/07/1995	LA				U	10/27/1994	pt recvd vax & 2 wks later pt began to exp discomfort @ inj site; There was no redness, induration, or swelling noted; The discomfort lasted for approx 2 wks, then began to abate;									N	09/28/1994	10/12/1994	14		PVT	PVT	NONE	NONE		~ ()~~~In patient	894305002K	1						1	Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072270	02/07/1995	NY	30.0	30		F	10/26/1994	pt recvd vax & exp tenderness @ the site of inj followed by sore throat 3 days later, fever to 102 & cough 5 days p/inj; pt was treated w/Augmentin for bronchitis;									Y	10/17/1994	10/20/1994	3	strep culture was neg;	OTH	OTH	Intal, Vanceril, Ventolin PRN	NONE	pt has a hx of asthma & allergy shots	~ ()~~~In patient	894305003K	1						1	Bronchitis; Cough; Injection site pain; Pharyngitis; Pyrexia	FLU3~PFIZER\WYETH~~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072271	02/07/1995	CT				F	10/26/1994	pt recvd vax & devel edema @ the inj site;									Y	10/19/1994	10/19/1994	0		PVT	PVT	unk	unk		~ ()~~~In patient	894305004K	1						1	Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072272	02/07/1995	CT				U	10/26/1994	pt recvd flu vax & devel edema @ the inj site;									Y	10/19/1994	10/19/1994	0		PVT	PVT	unk	unk		~ ()~~~In patient	894305005K	1						1	Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072273	02/07/1995	CT				U	10/26/1994	pt recvd vax & devel edema @ the inj site;									Y	10/19/1994	10/19/1994	0		PVT	PVT	unk	unk		~ ()~~~In patient	894305006K	1						1	Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072275	02/07/1995	GA				F	10/28/1994	pt recvd vax & w/in a few minutes pt c/o fuzzy vision; The problem resolved shortly thereafter;									Y	10/28/1994	10/28/1994	0		PVT	OTH	Vitamin D, INSULIN	diabetes & renal disease	pt has a hx of diabetes,hypertension, chronic renal failure & is on dialysis;	~ ()~~~In patient	894305008K	1						1	Amblyopia; Visual disturbance	FLU3~PFIZER\WYETH~4948144~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072276	02/07/1995	AL	29.0	29		F	10/27/1994	pt recvd vax & later that day devel numbness of the inj arm which improved until 4 days p/inj when condition worsened; seen by ER MD who noted poss edema; pt c/o burning sensation beginning near the shoulder & radiating down the arm;				Y	Y			Y	N	10/21/1994	10/21/1994	0	multiple operative procedures, MRI's, EMG's, physical therapy, & psychological couseling, stellate ganglion blocks, Beir blocks	PVT	OTH	unk	unk		~ ()~~~In patient	894306001K	1						1	Angiopathy; Neuropathy; Oedema; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4948043~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0072277	02/07/1995	CA	71.0			F	10/28/1994	pt recvd vax & 4 days later devel soreness & redness @ inj site & exp intermittent pinching sensation from elbow to the wrist; 1 wk p/inj pt c/o h/a & back pain;									U	10/20/1994	10/24/1994	4		OTH	OTH	Pilocar ophthalmic	NONE		~ ()~~~In patient	894306002K	1						1	Back pain; Headache; Injection site hypersensitivity; Injection site pain; Pain	FLU3~PFIZER\WYETH~~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072278	02/07/1995	WA				M	10/26/1994	pt recvd vax & exp inj site rxn characterized by warmth, soreness, swelling, & redness; The reporter states that inj was given w/TB syring w/ 1/2in needle; MED Affairs com: TB syringes are typically used for SC inj-flu is labelled for IM									U	10/20/1994	10/21/1994	1		OTH	OTH	unk	unk	unk	~ ()~~~In patient	894306003K	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4948148~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072279	02/07/1995	NJ	43.0	43		F	10/28/1994	pt recvd vax 225OCT94 & 25 to 26 hrs later exp disorientation which lasted about 5 hrs; pt did not notice any visual or other neuro defects; also been experiencing h/a w/photophobia; pt is afeb; pt attributes sx to meningeal irritation;									N	10/25/1994	10/26/1994	1		PVT	PVT	Ralafen 1000mg	systemic lupus erythematosus	pt has systemic lupus erythematosus	~ ()~~~In patient	894306004K	1						1	Confusional state; Headache; Meningism; Photophobia	FLU3~PFIZER\WYETH~4948115~3~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072280	02/07/1995	ND	34.0	34		F	10/21/1994	pt recvd vax & several hrs later devel redness & swelling @ the inj site; pt devel numbness & tingling in the injected lt arm; later that day devel twitching in lt leg which resolved w/in 2 hrs; next morning exp diarrhea									Y	10/20/1994	10/20/1994	0		MIL	PVT	ferrous sulfate q week	NONE	allergies to keflex, sulfa, trimpex, amoxicillin, tetanus toxoid	pt devel swollen, red hard arm coincident w/tetanus tox at age of 33~ ()~~~In patient	894306006K	1						1	Asthenia; Diarrhoea; Hyperhidrosis; Injection site hypersensitivity; Injection site mass; Injection site oedema; Muscle twitching; Paraesthesia	FLU3~PFIZER\WYETH~4948073~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072281	02/07/1995	MI	46.0	46		F	10/27/1994	pt recvd vax; devel sore throat, muscle aches, & swelling & induration at inject site; 2 days later, pt c/o upper resp congestion;									U	10/26/1994	10/27/1994	1		PVT	PVT	inderal oral, elavil oral;TB skin test;		none	~ ()~~~In patient	894306007K	1						1	Injection site mass; Injection site oedema; Myalgia; Pharyngitis	FLU3~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072282	02/07/1995	NY	42.0	42		F	10/27/1994	pt recvd vax;approx 1 day later,exp pain at inject site;pain abated,2 days p/ inj,exp swelling in rt posterior metacarpal area accompanied by pain;3 days later swelling/warmth were observed at inj site;pt cont to have dec use of 3 rt finger				Y					Y	10/25/1994	10/26/1994	1		PVT	PVT			allergic to pcn;	none~ ()~~~In patient	894306008K	1						1	Hypokinesia; Injection site oedema; Injection site pain; Oedema peripheral; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4948066~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072283	02/07/1995	MO	61.0	61		F	10/17/1994	pt recvd vax;devel flu-like sxs (aches,fatigue,sl cough); a few days later,devel a rash described as measle-like which was diff from the previous rash;									Y	10/10/1994	10/14/1994	4		PVT	PVT	doxepin po, atarax po;	recent hx of rash		~ ()~~~In patient	894306010K	1						1	Asthenia; Cough; Influenza; Myalgia; Rash	FLU3~PFIZER\WYETH~4948128~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072284	02/07/1995	PA	47.0	47		F	10/27/1994	pt recvd vax;devel a 2.5 to 3 inch raised, warm, erythematous area on the arm at the inject site;									Y	10/26/1994	10/27/1994	1		PVT	OTH	none	none	none	~ ()~~~In patient	894307001K	1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation; Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~PFIZER\WYETH~4948050~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4948050~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0072284	02/07/1995	MD	56.0	56		F	10/27/1994	pt recvd vax; devel a 2.5 - 3 raised, warm erythematous area on  the arm at inject site;									Y	10/21/1994	10/21/1994	0		PVT	PUB		none		~ ()~~~In patient	894307003K	1						2	Injection site hypersensitivity; Injection site mass; Vasodilatation; Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~PFIZER\WYETH~4948050~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4948050~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0072286	02/07/1995	OH				F	11/04/1994	pt recvd vax; devel lymphadenopathy;mom had similar rxn before;				Y					Y					OTH	OTH				in mom, similar rxn to vax;~ ()~~~In patient	894333006S	1						1	Lymphadenopathy	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0072287	02/07/1995	MA	46.0			F	11/22/1994	pt recvd vax;devel redness & induration (7cmx4cm) around inject site; no tx needed;				Y					U	10/31/1994	11/02/1994	2		PVT	PVT				~ ()~~~In patient	894334001S	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4948039~3~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072288	02/07/1995		1.0			U	11/17/1994	pt recvd vax; had fever 102 the day before vax; pt became lethargic & pale the day p/ recving vax;									U	11/14/1994	11/15/1994	1		PUB	PUB		fever 102 day a/ vax;		~ ()~~~In patient	894334002S	1						1	Pallor; Somnolence	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072289	02/07/1995	FL	39.0	39		F	11/08/1994	pt recvd vax;devl hives,swollen eyes;tx w/atarax;next day,rash,tx w/decadron;spleen enlarged,exp severe stiffnessd/joint pain;erythrocyte sedimentation rate elev;sore throat;lyme titer test result=295 ABR(wkly reactive)dx serum sickness;				Y					Y	10/13/1994	10/15/1994	2	20oct94 CBC,SMAC,RA profile,EKG,chest X-Ray,Urinalysis,Erythrocyte sedimentation rate,streptoccocal swab,all w/in nl limits;24oct94,lyme titer test=295 ABR,western blot tes neg;27oct94, CBC nl,erythrocyte sedimentation rate=51mm/hr;WBT neg;	PVT	OTH	none		hx of sulfa allergic	~ ()~~~In patient	894336001S	1						1	Arthralgia; Face oedema; Pharyngitis; Red blood cell sedimentation rate increased; Serum sickness; Splenomegaly; Urticaria	FLU3~PFIZER\WYETH~4948111~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072290	02/07/1995	UT				F	11/22/1994	pt recvd vax; 12 hrs later, devel urticaria x 3 wks as of the date of this rpt;				Y					U	11/01/1994	11/01/1994	0		OTH	OTH	effexor			~ ()~~~In patient	894336002S	1						1	Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072291	02/07/1995	PA	32.0	32		M	11/18/1994	pt recvd vax;devel gen body hives;pt indicated that the hives may have been a rxn or allergy to thimesoral									Y	11/08/1994	11/17/1994	9		OTH	OTH	none	unknown		~ ()~~~In patient	894336003S	1						1	Hypersensitivity; Rash; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072292	02/07/1995	CA				F	11/23/1994	pt recvd vax;elev INR results;pharmacist rpts that pt Coumadin dose was dec in response to elev in INR;									U	10/06/1994			INR=5.2 21nov94; INR=4.5 22nov94;	OTH	OTH	coumadin	none	none	~ ()~~~In patient	894336004S	1						1	Laboratory test abnormal	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072293	02/07/1995	NE	24.0	24		F	12/06/1994	pt recvd vax;devel redness, swelling & tenderness at injec site,lasted 2 days;									Y	11/02/1994	11/03/1994	1		PVT	PVT	prenatal vits	none		~ ()~~~In patient	894340001S	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4948147~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072294	02/07/1995	CT	39.0	39		F	12/05/1994	pt recvd vax; devel an erythematous, hot area (6cm) at inject site,resolved in 1-2 days;									Y	11/07/1994	11/07/1994	0		PVT	PVT	none	none	none	~ ()~~~In patient	894340002S	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PFIZER\WYETH~4948114~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072295	02/07/1995	MI				F	11/02/1994	pt recvd vax;devel a dec platelet count,dec white blood cell count,petechiae & bleeding gums;									U	10/01/1994				OTH	OTH				~ ()~~~In patient	894341002S	1						1	Gingival bleeding; Leukopenia; Petechiae; Thrombocytopenia	FLU3~PFIZER\WYETH~4948106~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072296	02/07/1995	MI				U	11/02/1994	pt recvd vax;devel n,fever & pain;tx w/ steroids;									U					OTH	OTH				~ ()~~~In patient	894341003S	1						1	Nausea; Pain; Pyrexia	FLU3~PFIZER\WYETH~4948106~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072297	02/07/1995	MI				U	11/02/1994	pt recvd vax;devel fever,n,& a neck stiffness;									U					OTH	OTH				~ ()~~~In patient	894341004S	1						1	Nausea; Nuchal rigidity; Pyrexia	FLU3~PFIZER\WYETH~4948106~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072298	02/07/1995	MI				U	11/02/1994	pt recvd vax; devel fever;									U					OTH	OTH				~ ()~~~In patient	894341005S	1						1	Pyrexia	FLU3~PFIZER\WYETH~4948106~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072299	02/07/1995	OH	45.0	45		F	11/09/1994	pt recvd vax; devel edema, erythema & pruritus at inject site;									Y	10/11/1994	10/13/1994	2		PVT	PVT		none	hx of allergy to bactrim;	~ ()~~~In patient	894342001L	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4948053~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072300	02/07/1995	OH	38.0	38		F	11/09/1994	pt recvd vax;devel edema, erythema, & pruritus at inject site;									Y	10/12/1994	10/13/1994	1		PVT	PVT	quibron	none	allergy to pcn, anspor & mexofin;	~ ()~~~In patient	894342002L	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4948053~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072301	02/07/1995	OH	45.0	45		F	11/09/1994	pt recvd vax; devel edema, erythema & pruritus at inject site;									Y	10/27/1994	10/28/1994	1		PVT	PVT	none	none		~ ()~~~In patient	894342003L	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4948053~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072302	02/07/1995	TN	34.0			F	11/23/1994	pt recvd vax;exp tingling pain radiating down the arm & loss of grip;pain cont to radiate up & down the arm from inject site;									N	10/27/1994	10/27/1994	0		MIL	MIL	estrogen	none		~ ()~~~In patient	894342005S	1						1	Injection site pain; Myasthenic syndrome; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4948195~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072303	02/07/1995	NE	64.0	64		F	12/06/1994	pt recvd vax;devel redness, swelling & tenderness at inject site; lasted x 2 days;									Y	11/01/1994	11/01/1994	0		PVT	PVT	premarin, levothroid	none	hx of hypothyroidism & estrogen replacement therapy;	~ ()~~~In patient	894343001S	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4948147~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072304	02/07/1995	NE	85.0	85		F	12/06/1994	pt recvd vax; devel redness, swelling, tenderness at inject site,lasted x 2 days;									Y	10/25/1994				PVT	PVT	timolide, indomethacin, darvocet N-100;	none	hx of hypertension & osteoarthritis;	~ ()~~~In patient	894343002S	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4948147~4~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072305	02/07/1995	NE	75.0	75		F	12/06/1994	pt recvd vax; devel redness,swelling, tenderness at inject site,lasted x 2 days;									Y	10/18/1994				PVT	PVT	zoloft, voltaren	none	hx of neck pain & depression;allergic to pcn, dph;	~ ()~~~In patient	894343003S	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4948128~5~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072306	02/07/1995	WY	66.0	66		F	12/06/1994	pt recvd vax; devel redness, swelling, tenderness at inject site;lasted 2 days;									Y	11/04/1994				PVT	PVT	synthroid, procardia,pravachol,asa,colestipol	none	hx of hypertension,hyperlipidemia,diabetes mellitus type II,bradycardia & hypothyroidism;	~ ()~~~In patient	894343004S	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4948147~3~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072307	02/07/1995	NE	66.0	66		F	12/06/1994	pt recvd vax; devel redness,swelling, tenderness at inject site, lasted 2 days									Y	10/31/1994				PVT	PVT	timolol, calan sr, maxzide, asa	none	allergic to pcn;hx of hypertension,coronary heart disease,chronic obstructive pulmonary disease,& hyperlipidemia;	~ ()~~~In patient	894343005S	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4948147~5~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072308	02/07/1995	NE	79.0	79		M	12/06/1994	pt recvd vax; devel redness,swelling,tenderness at inject site,lasted 2 days;									Y	11/18/1994				PVT	PVT	procardia xl, asa,tagamet	none	hx of hypertension,coronary disease,chronic obstructive pulmonary disease & rhinitis;	~ ()~~~In patient	894343006S	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4948147~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072309	02/07/1995	NE	56.0	56		F	12/06/1994	pt recvd vax; devel redness, swelling, tenderness at inject site; lasted 2 days;									Y	10/20/1994				PVT	PVT	azmacort,maxair;	none	hx of chronic allergy rhinitis & is allergic to pcn & doxyxycline;	~ ()~~~In patient	894343007S	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4948147~3~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072310	02/07/1995	NE	47.0	47		F	12/06/1994	pt recvd vax;devel redness, swelling & tenderness at inject site, lasted 2 days;									Y	11/01/1994				PVT	PVT	none	none	hx of rhinitis;	~ ()~~~In patient	894343008S	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4948147~7+~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072311	02/07/1995	NE	74.0	74		U	12/06/1994	pt recvd vax;devel redness,swelling,tenderness at inject site;lasted 2 days;									Y	10/13/1994				PVT	PVT	isoprin sr, procardia;	none	allergic to indocin, streptomycin & codeine & also has hx of dependent edema;	~ ()~~~In patient	894343009S	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4948147~7+~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072312	02/07/1995	FL	90.0	90		F	11/30/1994	pt recvd vax & devel upper-resp symptoms with congestion, elevated temp, & cough; pt went on to be treated w/ATB;	Y	11/15/1994		Y					N	11/05/1994	11/15/1994	10	lot# 4948142 was reviewed & found to be satisfactory;	PVT	PVT	unk	unk	Alzheimer's disease;	~ ()~~~In patient	894343010S	1						1	Cough; Pharyngitis; Pyrexia; Rhinitis	FLU3~PFIZER\WYETH~4948142~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0072313	02/07/1995	FL	96.0			F	11/30/1994	pt recvd vax & devel upper resp symptoms w/congestion, cough, elevated temp, & shortness of breath; x-ray showed congestive heart failure; Rocephin IM was given;	Y	11/14/1994		Y					N	10/27/1994	11/13/1994	17	lot# 4948142 was reviewed & found to be satisfactory;	PVT	PVT	unk	unk	Congestive heart failure, anemia, atrial fibrillation;	~ ()~~~In patient	894343011S	1						1	Cough; Dyspnoea; Pharyngitis; Pyrexia; Rhinitis	FLU3~PFIZER\WYETH~4948142~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0072314	02/07/1995	FL	81.0	81		F	11/30/1994	pt recvd vax & devel upper-respiratory symptoms with cough & congestion; oxygen was continued;	Y	11/19/1994		Y					N	10/13/1994	11/18/1994	36	lot# 4948142 was reviewed & found to be satisfactory;	PVT	PVT	unk	unk	COPD, diabetes, hypertension, emphysema;	~ ()~~~In patient	894343012S	1						1	Cough; Hypoxia; Pharyngitis; Rhinitis	FLU3~PFIZER\WYETH~4948142~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0072315	02/07/1995	FL	86.0	86		F	11/30/1994	pt recvd vax & devel upper-respiratory symptoms with congestion & wheezing; oxygen was continued; cause of death was acute coronary insufficiency;	Y	11/14/1994		Y					N	11/08/1994	11/14/1994	6	lot# 4948142 was reviewed & found to be satisfactory;	PVT	PVT	unk	unk	Arteriosclerotic heart disease, COPD, hypertension, CVA, glaucoma;	~ ()~~~In patient	894343013S	1						1	Angina pectoris; Asthma; Pharyngitis; Rhinitis	FLU3~PFIZER\WYETH~4948142~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0072316	02/07/1995	TX				F	12/06/1994	pt recvd vax & c/o soreness @ the inj site; pt is unable to raise arm above head;									N					OTH	OTH	unk	unk		~ ()~~~In patient	894346004S	1						1	Hypokinesia; Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072317	02/07/1995	CA	46.0	46		F	11/30/1994	pt recvd vax & was dx w/torn rotator cuff; MD stated pt may have begun twisting & flinging the arm to relieve post-vaccination soreness @ the site of inj & tore the rotator cuff; Reporter indicated vax was delivered to proper area of arm;				Y					Y	10/26/1994	10/29/1994	3		PVT	PVT	unk	unk		~ ()~~~In patient	894346005S	1						1	Arthropathy; Hypokinesia; Injection site pain; Myalgia; Pain; Tendon disorder	FLU3~PFIZER\WYETH~4948101~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072319	02/07/1995	ND	41.0	41		F	12/02/1994	pt recvd vax & w/in 24 hrs pt devel soreness @ inj site; the pain had not resolved as of 5 wks p/inj & pt is unable to raise arm above head as a result of pain; Reporter indicates that it is likely that inj was given w/21 gauge, 1in needle									Y	10/18/1994	10/21/1994	3		PVT	OTH	unk	unk		~ ()~~~In patient	894346007S	1						1	Hypokinesia; Injection site pain; Myalgia; Pain	FLU3~PFIZER\WYETH~4948108~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072320	02/07/1995	ND				M	12/02/1994	pt recvd vax & w/in 24 hrs pt devel soreness @ inj site; pain had not resolved as of 5 wks p/inj & pt is unable to raise hand above head as a result of pain; Reporter indicated inj was given w/21 gauge, 1 in needle-instead of 25 gauge, 5/8i				Y					N	10/28/1994	10/29/1994	1		PVT	OTH	KCL, Atenolol	unk		~ ()~~~In patient	894346008S	1						1	Hypokinesia; Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072321	02/07/1995	ND	28.0	28		F	12/02/1994	pt recvd vax & w/in 48 hrs pt devel soreness @ the inj site; pain had not resolved as of 5 wks p/inj & pt is unable to raise the lt arm above the head as a result of the pain; reporter indicated inj was given w/21 gauge, 1 in needle									Y	11/08/1994	11/08/1994	0		OTH	OTH	unk	unk		~ ()~~~In patient	894346009S	1						1	Hypokinesia; Injection site pain; Myalgia; Pain	FLU3~PFIZER\WYETH~4948108~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072322	02/07/1995	OH	43.0	43		F	11/28/1994	pt recvd vax & exp pain @ inj site which had persisted for 6 wks as of the date of their report;									U	10/12/1994	10/12/1994	0		PUB	OTH	unk	NONE		~ ()~~~In patient	894346010S	1						1	Injection site pain	FLU3~PFIZER\WYETH~4948100~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072324	02/07/1995	NC	65.0			M	12/15/1994	pt recvd vax & devel itchy skin, like something is crawling under skin; pt was seen by family MD who suspected scabies; pt was treated w/Lindane & epsom salt bath for itchiness;				Y					U	12/08/1994				PUB	PUB	Lotensin	unk	pt works outdoors & uses insect repellent several times daily	~ ()~~~In patient	894354003S	1						1	Infection; Pruritus	FLU3~PFIZER\WYETH~4948107~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072325	02/07/1995	IA	86.0	86		F	12/16/1994	pt recvd vax & pt c/o that the area around inj became hot, swollen & itchy;									Y	10/25/1994	10/25/1994	0		OTH	OTH	unk	unk		~ ()~~~In patient	894354004S	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4948073~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072326	02/07/1995	IA	74.0	74		F	12/16/1994	pt recvd vax & area 1st became pink & 2 days later became dark red; pt also c/o that the area around the inj became hot & swollen;									Y	10/25/1994	10/26/1994	1		OTH	OTH	unk	unk	pt had been travelling out of the country prior to the inj, but denies any vaccinations	~ ()~~~In patient	894354005S	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948033~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072327	02/07/1995	IA	74.0	74		F	12/16/1994	pt recvd vax & c/o that the area around inj became hot, swollen & itchy;									N	10/25/1994	10/26/1994	1		OTH	OTH	unk	unk		~ ()~~~In patient	894354006S	1						1	Dyspepsia; Headache; Hypokalaemia; Injection site oedema; Pruritus; Pyrexia; Somnolence; Vasodilatation	FLU3~PFIZER\WYETH~7948043~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072328	02/07/1995	NV	72.0	72		M	12/19/1994	pt recvd vax 7OCT94 & 2 to 3 days later devel muscle pain in arm of inj & shoulder; pt is only able to raise arm to shoulder level & required assistance of other arm to raise it any further; also numb; sweating-foul odor, neuralgia, weaknes				Y					N	10/07/1994	10/09/1994	2		PUB	PUB	unk	unk	pt was dx w/stomach tumor; surgery was planned for 18NOV94;	~ ()~~~In patient	894356007Z	1						1	Hypokinesia; Insomnia; Myalgia; Myasthenic syndrome; Neuralgia; Pain; Paraesthesia; Skin odour abnormal	FLU3~PFIZER\WYETH~4948119~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072329	02/07/1995	TN	57.0			M	12/19/1994	pt recvd vax & exp a generalized body rash;									U	12/05/1994	12/19/1994	14		PUB	OTH	Guaifensin	none			894362001S	1						1	Rash	FLU3~PFIZER\WYETH~4948116~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072330	02/07/1995	ND	55.0	55		F	12/20/1994	pt recvd vax & devel intermittent spasms of muscles in neck, rt shoulder & rt arm; consulted chiropractor who was unable to provide relief; pt is currently being treated w/unspecified NSAID;				Y					N	10/27/1994	10/27/1994	0		OTH	OTH	unk	NONE		~ ()~~~In patient	894362002S	1						1	Hypertonia	FLU3~PFIZER\WYETH~~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072331	02/07/1995	NJ	70.0			M	12/22/1994	pt recvd vax & devel urticaria, facial edema, & a fever that lasted 7-10 days; pt has since recovered;									Y	10/18/1994	12/12/1994	55		OTH	PUB	NONE	NONE		~ ()~~~In patient	894362003S	1						1	Face oedema; Pyrexia; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072332	02/07/1995	MO	37.0	37		M	12/19/1994	pt recvd vax & was dx w/optic neuritis of the lt eye; pt cont to exp loss of visual field in the lt eye; pt has consulted both an opthalmologist & a neurologist;				Y					N	12/02/1994	12/07/1994	5	MRI-results unk	PVT	PVT	Azulfidine 500 mg twice daily	NONE	pt is currently being treated for ulcerative colitis	~ ()~~~In patient	894363001S	1						1	Optic neuritis; Visual field defect	FLU3~PFIZER\WYETH~4948108~1~SC~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072335	02/07/1995	MA	35.0			F	12/07/1994	pt recvd vax & 5 mins later devel generalized hives & itching, c/o feeling faint; pt was treated successfully w/IV DPH;									Y	11/01/1994				MIL	OTH	unk	NONE	pt has a hx of asthma	~ ()~~~In patient	895003001S	1						1	Dizziness; Pruritus; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072336	02/07/1995	ME				F	11/30/1994	pt recvd vax & devel bronchitis OCT94; 28NOV94 devel myalgia, joint pain, neuropathy in feet, sore throat, ear pain, h/a, upset stomach;									U					OTH	OTH	unk	unk	pt has a hx of EOS myalgia synd	~ ()~~~In patient	895003002S	1						1	Arthralgia; Bronchitis; Dyspepsia; Ear pain; Headache; Myalgia; Neuropathy; Pharyngitis	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072337	02/07/1995	PA				U	12/14/1994	pt recvd vax 25OCT94 & next day devel heaviness in chest, followed by achiness, fever, sore throat & dizziness;seen by MD 27OCT94 & realized had 2 flu shots; 30OCT94 devel chest pains; cardiologist noted tachycardia HR 130BPM; also SOB, h/a				Y					N	10/25/1994	10/26/1994	1		PVT	PVT	NONE	NONE		pt exp fever, achiness, upset stomach w/flu vax #1 on 15OCT94~ ()~~~In patient	895003002Z	1						1	Chest pain; Dizziness; Dyspnoea; Headache; Myalgia; Pharyngitis; Pyrexia; Tachycardia	FLU3~PFIZER\WYETH~494816~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072338	02/07/1995	OH	15.0			F	12/12/1994	pt recvd vax & devel an abscess; reported was not sure of the location of the abscess;									U					OTH	OTH	unk	unk		~ ()~~~In patient	895003003S	1						1	Abscess	FLU3~PFIZER\WYETH~4948080~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072339	02/07/1995	MA	29.0	29		F	12/19/1994	pt recvd vax & devel a papulovesicular rash @ inj site which was treated w/topical steroid;				Y					U	12/12/1994	12/14/1994	2		MIL	OTH	unk	unk		~ ()~~~In patient	895003005S	1						1	Dermatitis bullous; Injection site hypersensitivity; Oedema peripheral; Pruritus	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072340	02/07/1995	MA	17.0			M	12/21/1994	pt recvd vax & states that had a pos HTLV blood test which was done the same day flu shot given;									U	12/01/1994	12/01/1994	0		OTH	OTH	unk	unk		~ ()~~~In patient	895003006S	1						1	Laboratory test abnormal	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072341	02/07/1995	AZ	67.0	67		F	12/14/1994	pt recvd vax & inj site became reddened, hot, stiff & painful; w/in 24 hrs pt exp generalized joint aching, feeling hot & cold, fever, noc sweats; c/o neck stiffness & soreness; sx persisted for 2 to 3 days;									Y	11/30/1994	11/30/1994	0		PVT	PVT	unk	none	pt has a hx of environmental allergies in autumn	pt exp similar react to an flu vax 2 yrs ago;~ ()~~~In patient	895010001S	1						1	Arthralgia; Chills; Hyperhidrosis; Injection site hypersensitivity; Injection site pain; Myalgia; Nuchal rigidity; Pyrexia	FLU3~PFIZER\WYETH~4948128~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072470	02/07/1995	NC	39.0	39		F	10/26/1994	pt recvd vax; devel cellulitis characterized by redness, warmth & swelling; tx w/ keflex & dph;				Y					Y	10/11/1994	10/12/1994	1		PVT	PVT			none	~ ()~~~In patient	894307004K	1						1	Cellulitis; Oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948043~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072471	02/07/1995	NC	40.0	39		F	10/26/1994	pt recvd vax; devel rxn characterized by redness & warmth;									Y	10/11/1994	10/13/1994	2		PVT	PVT			none	~ ()~~~In patient	894307005K	1						1	Vasodilatation	FLU3~PFIZER\WYETH~4948043~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072472	02/07/1995	NC	47.0	47		F	10/26/1994	pt recvd vax;devel allergic rxn characterized by tenderness & swelling;no evidence of cellulitis;tx w/ analgesics;				Y					Y	10/18/1994	10/18/1994	0		PVT	PVT		none	none	none~ ()~~~In patient	894307006K	1						1	Hypersensitivity; Oedema; Pain	FLU3~PFIZER\WYETH~4948043~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072473	02/07/1995	NJ	40.0	40		F	10/31/1994	pt recvd vax; exp tearing of lt eye which progressed to facial nerve paralysis by 29oct94;tx: po steroids;									Y	10/26/1994	10/30/1994	4		PUB	PVT	none	none		~ ()~~~In patient	894307008K	1						1	Facial palsy; Lacrimal disorder	FLU3~PFIZER\WYETH~4948152~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072474	02/07/1995	FL				U	10/31/1994	pt recvd vax;exp pain, redness at inject site; med affairs comment:flu shield is labelled for IM adm only;									U					PVT	OTH			none	~ ()~~~In patient	894307009K	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~~UNK~SC~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072475	02/07/1995	CA				U	10/24/1994	pt recvd vax; devel redness, swelling & pain at inject site									Y					PVT	OTH				~ ()~~~In patient	894307010K	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4948118~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072476	02/07/1995	CA				U	10/24/1994	pt recvd vax; devel redness, swelling & pain at inject site;									Y					PVT	OTH				~ ()~~~In patient	894307011K	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4948118~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072477	02/07/1995	CA				U	10/24/1994	pt recvd vax;devel redness, swelling & pain at inject site;									Y					PVT	OTH				~ ()~~~In patient	894307012K	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4948118~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072478	02/07/1995	AZ	33.0	33		F	10/26/1994	pt recvd vax; exp induration, redness & itching at inject site;									Y	10/10/1994	10/12/1994	2		OTH	OTH				~ ()~~~In patient	894308001K	1						1	Injection site hypersensitivity; Injection site mass; Pruritus; Rash	FLU3~PFIZER\WYETH~4948103~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072479	02/07/1995	AZ				U	10/26/1994	pt recvd vax;exp induration,redness & itching at inject site;									Y	10/10/1994	10/12/1994	2		OTH	OTH				~ ()~~~In patient	894308002K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4948103~6~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072480	02/07/1995	AZ	42.0	41		F	10/26/1994	pt recvd vax;exp induration,redness,itching at inject site; tx: hydrocortisone;									Y	10/04/1994	10/06/1994	2		OTH	OTH				none~ ()~~~In patient	894308003K	1						1	Injection site hypersensitivity; Injection site mass; Pruritus	FLU3~PFIZER\WYETH~4948103~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072481	02/07/1995	FL	9.0			F	11/04/1994	pt recvd vax; next am,devel v & d;				Y					U	11/03/1994	11/04/1994	1		OTH	OTH				~ ()~~~In patient	894308012K	1						1	Diarrhoea; Vomiting	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072482	02/07/1995	FL	47.0	47		F	11/03/1994	pt recvd vax; devel redness, warmth & induration  at inject site									Y	10/14/1994	10/15/1994	1		PVT	PVT		none	none	none~ ()~~~In patient	894308013K	1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~PFIZER\WYETH~4948076~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072483	02/07/1995	FL				U	10/27/1994	pt recvd vax; exp a vasovagal rxn characterized by paleness, dec in BP,tachycardia & loss of consciousness;epi adm p/vax; rxn resolved;				Y					Y	10/26/1994	10/26/1994	0		OTH	OTH			none	~ ()~~~In patient	894308014K	1						1	Hypotension; Pallor; Syncope; Tachycardia; Hypotension; Pallor; Syncope; Tachycardia	FLU3~PFIZER\WYETH~4948126~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4948126~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0072483	02/07/1995	FL				U	10/27/1994	pt recvd vax & 10 mins later, pt exp vasovagal react characterized by paleness, drop in BP, tachycardia, & loss of consciousness; following administration of Epi, react resolved;				Y					Y	10/26/1994	10/26/1994	0		OTH	OTH	unk	unk		~ ()~~~In patient	894308011K	1						2	Hypotension; Pallor; Syncope; Tachycardia; Hypotension; Pallor; Syncope; Tachycardia	FLU3~PFIZER\WYETH~4948126~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4948126~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0072484	02/07/1995	FL	64.0	64		F	11/03/1994	pt recvd vax; 1 day later, pt devel redness, warmth & induration at inject site;									Y	10/14/1994	10/15/1994	1		PVT	PVT	dyazide, dyanacirc, proventil, synthroid, alupent, vanceril;	none		~ ()~~~In patient	894308015K	1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~PFIZER\WYETH~4948076~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072485	02/07/1995	FL				U	10/27/1994	pt recvd vax; exp a vasovagal rxn characterized by paleness, tachycardia & a dec in BP;epi adm p/vax; rxn resolved;				Y					Y	10/26/1994	10/26/1994	0		OTH	OTH				~ ()~~~In patient	894308017K	1						1	Hypotension; Pallor; Syncope; Tachycardia	FLU3~PFIZER\WYETH~4948126~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072487	02/07/1995	KY	72.0	72		F	11/01/1994	pt recvd vax;devel swelling on rt side,which resulted in difficulty talking;took a Xanax just p/tongue swelling began;p/ tx w/ IM dph & ice chips,condition improved;later worse,pt tx w/decadron,dph;BP=158/96;P=72;color good;				Y					Y	11/01/1994	11/01/1994	0	BP=158/96; P=72;	PVT	PVT	catapres, tenormin, feldene	none	hx of hypertension & osteoporosis;allergic to unspecified arthritis meds;	~ ()~~~In patient	894311002K	1						1	Hypertension; Speech disorder; Tongue oedema	FLU3~PFIZER\WYETH~4948110~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072488	02/07/1995	MD	38.0	38		F	10/27/1994	pt recvd vax;devel rxn dx as cellulitis characterized by redness,warmth,induration,pain & swelling from the elbow to the shoulder w/ a four inch diam site of rxn;was tx w/ amoxicillin;				Y					Y	10/25/1994	10/26/1994	1		UNK	UNK				~ ()~~~In patient	894311003K	1						1	Cellulitis; Oedema peripheral; Pain; Skin nodule; Vasodilatation	FLU3~PFIZER\WYETH~4948066~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072489	02/07/1995	MD	29.0	29		M	10/27/1994	pt recvd vax;devel redness,induration,edema & warmth at inject site;tx w/ dph & cold compresses to the site;as of 11nov94,inject site sl red & pruritic;									Y	10/26/1994	10/27/1994	1		PVT	PVT	none	none	none	none~ ()~~~In patient	894311004K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4948066~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072490	02/07/1995	MD	61.0	61		F	10/27/1994	pt recvd vax;devel redness, warmth,induration & pain over a 1 inch area at inject site;									Y	10/25/1994	10/26/1994	1		PVT	PVT	none	none	none	~ ()~~~In patient	894311005K	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4948066~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072491	02/07/1995	MD	37.0	37		F	10/27/1994	pt recvd vax;2 hrs later, devel redness, swelling & pain at inject site;tx w/ Motrin & cold compresses to site;									Y	10/26/1994	10/27/1994	1		PVT	PVT	none	none	none	~ ()~~~In patient	894311006K	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4948066~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072492	02/07/1995	MD	49.0	49		F	10/28/1994	pt recvd vax;approx 12 hrs later, pt exp ha & chills which which resolved in about  12 hrs;									Y	10/18/1994	10/18/1994	0		PVT	PVT	none	none	none	none~ ()~~~In patient	894311007K	1						1	Chills; Headache	FLU3~PFIZER\WYETH~4948066~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072493	02/07/1995	VA	54.0	54		F	10/28/1994	pt recvd vax;12 hrs later, pt exp ha & chills which resolved in about 12 hrs;									Y	10/21/1994	10/21/1994	0		PVT	PVT	none	none		~ ()~~~In patient	894311008K	1						1	Chills; Headache	FLU3~PFIZER\WYETH~4948066~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072494	02/07/1995	MD				U	11/02/1994	pt recvd vax;2-3 hrs later, devel fever, congestion, cough & aches;									U		10/27/1994			OTH	PVT				~ ()~~~In patient	894312003K	1						1	Cough; Pyrexia; Rhinitis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072495	02/07/1995	FL	40.0			F	10/31/1994	pt recvd vax;exp numbness at site of inject;achiness from the site to neck; also exp dizziness & insomnia for 2 days p/ inject;arm becomes more numb when lies down;									N	10/28/1994	10/30/1994	2		PVT	OTH		none		~ ()~~~In patient	894318001K	1						1	Dizziness; Hypoaesthesia; Injection site pain; Insomnia; Myalgia; Neck pain	FLU3~PFIZER\WYETH~4948138~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072496	02/07/1995	WY	64.0	64		F	11/04/1994	pt recvd vax; devel redness, swelling & tenderness at inject site,lasted x 2 days;									Y	10/26/1994				PVT	PVT	lasix, lanoxin,slow k,atrovent,premarin,calcium,proventil	none	pt has chronic obstructive pulmonary disease,congestive heart failure,hx of iron overload & hypoxemia;	~ ()~~~In patient	894318002K	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4948147~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072497	02/07/1995	NJ	23.0			F	11/07/1994	pt recvd vax; 1 day later, devel swollen glands in the neck & underarm area;									U	11/04/1994	11/05/1994	1		PVT	PVT		none	none	none~ ()~~~In patient	894318004K	1						1	Lymphadenopathy	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072498	02/07/1995	NY	71.0	71		F	11/10/1994	pt recvd vax; 3 wks later, presented w/ rt sided shingles;				Y					U	10/11/1994	11/01/1994	21		PVT	PVT				~ ()~~~In patient	894318005K	1						1	Dermatitis bullous; Herpes zoster; Pain	FLU3~PFIZER\WYETH~4948032~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072499	02/07/1995	AL	41.0			F	11/09/1994	pt recvd vax; 1 day later, pt devel erythema, swelling & tenderness at inject site;									U	11/09/1994	11/09/1994	0		PUB	OTH	none			~ ()~~~In patient	894319002K	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4948039~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072500	02/07/1995	CT	55.0	55		F	11/07/1994	pt recvd vax;later in the day, pt devel erythematous, hot area w/ induration at inject site which resolved w/in 5 days;									Y	10/26/1994	10/26/1994	0		PVT	PVT	none	none	none	~ ()~~~In patient	894319003K	1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~PFIZER\WYETH~4948114~4~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072501	02/07/1995	CT	55.0	54		F	11/07/1994	pt recvd vax;next day, devel erythematous,hot area w/ induration at inject site,resolved w/in 2 days;									Y	10/26/1994	10/27/1994	1		PVT	PVT	prilosec, provera, synthroid	none	pt has hx of allergies: pcn, insects;	~ ()~~~In patient	894319004K	1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~PFIZER\WYETH~4948114~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072502	02/07/1995	CT	45.0	45		F	11/07/1994	pt recvd vax;pt devel erythematous,hot area at inject site, resolved in 2 days;									Y	10/25/1994	10/26/1994	1		PVT	PVT	estrace, provera	none	pt has hx of salicylate intolerance	~ ()~~~In patient	894319005K	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PFIZER\WYETH~4948114~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072503	02/07/1995	CT	65.0	65		F	11/07/1994	pt recvd vax;devel a pruritic,erythematous area w/ induration at inject site,lasting 4-5 hrs;									Y	10/25/1994	10/25/1994	0		PVT	PVT	levothyroxine, macrobid, alprazolam;	none	none	none~ ()~~~In patient	894319006K	1						1	Injection site hypersensitivity; Injection site mass; Pruritus	FLU3~PFIZER\WYETH~4948114~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072504	02/07/1995	CT	44.0	44		F	11/07/1994	pt recvd vax;devel erythematous hot area w/ induration at inject site which worsened over the next 2 days;cellulitis was dx;tx w/ Keflex;resolved w/in 2 days;									Y	10/25/1994	10/26/1994	1		PVT	PVT	provera, ortho-est,zestril;	none		~ ()~~~In patient	894319007K	1						1	Cellulitis; Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4948114~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072505	02/07/1995	CT	59.0	59		F	11/07/1994	pt recvd vax;devel erythematous,hot area w/ some ecchymosis at inject site;took erythromicin ethylsuccinate for 4 days & condition resolved w/in 3 wks;										11/04/1994	11/05/1994	1		PVT	PVT	naprosyn	none	pt is allergic to pcn;	~ ()~~~In patient	894319008K	1						1	Ecchymosis; Injection site hypersensitivity; Vasodilatation	FLU3~PFIZER\WYETH~4948114~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072506	02/07/1995	MA	83.0			F	11/08/1994	pt recvd vax;1 day later, pt devel Bell's palsy;									Y	11/01/1994	11/02/1994	1		PVT	OTH		none		~ ()~~~In patient	894319009K	1						1	Facial palsy	FLU3~CONNAUGHT LABORATORIES~4851025~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0072507	02/07/1995	PA	43.0	43		F	11/04/1994	pt recvd vax;2 days later,devel a large,round,red,hot,hard,sl swollen wheal (5cm) at inject site; tx w/ warm compresses;									Y	11/01/1994	11/03/1994	2		PUB	OTH	none	none		~ ()~~~In patient	894319010K	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948115~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072508	02/07/1995	PA				U	11/04/1994	pt recvd vax;devel pain, warmth,swelling & erythema at inject site;									U					PUB	OTH				~ ()~~~In patient	894319011K	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4948115~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072509	02/07/1995	PA				U	11/04/1994	pt recvd vax & devel pain, warmth, swelling, & erythema @ inj site;									U					PUB	OTH	unk	unk		~ ()~~~In patient	894319012K	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4948115~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072510	02/07/1995	MI	68.0	68		M	11/14/1994	pt recvd vax & immed following inj exp severe h/a, which were treated w/non-prescription analgesics; 7NOV94 pt devel shingles, for which was treated w/Zovirac & Darvocet				Y					U	09/21/1994	09/21/1994	0		PVT	PVT	Micronase, Lopressor, slow-K	NONE	pt has a hx of diabetes & HTN	~ ()~~~In patient	894320001K	1						1	Headache; Herpes zoster	FLU3~PFIZER\WYETH~4948045~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072511	02/07/1995	CA				F	11/09/1994	pt recvd vax & pt devel a hematoma, rash which spread down arm, & pruritus; pt was treated w/IM or oral steroids;									U					PVT	PVT	unk	unk		~ ()~~~In patient	894320003K	1						1	Haemorrhage; Pruritus; Rash	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072512	02/07/1995	CA				U	11/09/1994	pt recvd flu vax & devel inj site edema & rash;									U					PVT	PVT	unk	unk		~ ()~~~In patient	894320004K	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072513	02/07/1995	CA				U	11/09/1994	pt recvd flu vax & devel inj site edema & rash									U					PVT	PVT	unk	unk		~ ()~~~In patient	894320005K	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072514	02/07/1995	PA	39.0	39		F	11/03/1994	pt recvd flu vax & w/in 10mins exp numbness of the lips & tongue; pt described rxn as similar to rxn had to inj of Lupron 1 1/2 yrs ago; sx resolved spontaneously w/in 15 to 30 mins;									Y	11/01/1994	11/01/1994	0		PUB	OTH	unk	NONE	pt has a hx of a rxn to Lupron inj, which contains Polysorbate-80	~ ()~~~In patient	894322001S	1						1	Paraesthesia; Paraesthesia oral	FLU3~PFIZER\WYETH~4948115~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072515	02/07/1995	WI	22.0	22		M	11/02/1994	pt recvd vax & 3 days later pt devel an allerg rxn characterized by hives, angioedema, tightness in the chest, & wheezing; pt was treated in ER w/SOlumedrol IV, Zantac, Sus-phrine, & DPH & the rxn resolved;				Y					Y	10/27/1994	10/30/1994	3	31OCT94 differential Blood Count WNL; Erythrocyte Sedimmentation rate 0mm/hr (nl= 1-13mm/hr); WBC count 7.4x1000/cubic mm (nl=4.3-10.8x1000/cubic mm)	OTH	PVT	NONE	NONE	pt has a hx of atopic dermatitis (w/itching) & exercise induced asthma; has no known allergies; recvd flu vax once a/ w/o sequelae;	~ ()~~~In patient	894322002S	1						1	Anaphylactoid reaction; Angioneurotic oedema; Asthma; Chest pain; Hypersensitivity; Red blood cell sedimentation rate decreased; Urticaria	FLU3~PFIZER\WYETH~4948033~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072516	02/07/1995	OH	63.0	63		F	10/31/1994	pt recvd vax & 4 hrs later devel pain in the back which radiated around the abdo & down the legs; described this as like paralysis; the pain/paralysis abated & was followed by 5 hrs of weakness; weakness resolved w/o sequelae;									Y	10/21/1994	10/21/1994	0		PVT	PVT	Fiorinal, Naprosyn	unk	pt has a hx of reactive hypoglycemia; pt last flu shot was in 1987; @ that time got one-half the recommended dose @ two visits;	~ ()~~~In patient	894322004L	1						1	Abdominal pain; Asthenia; Back pain; Pain; Paralysis	FLU3~PFIZER\WYETH~4948100~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072517	02/07/1995	OH	51.0	51		F	11/07/1994	pt recvd flu vax & pt devel redness @ the inj site; later that month began to exp cramping & weakness & tingling in both feet;				Y					U	11/03/1994	11/03/1994	0		PVT	OTH		unk	unk	~ ()~~~In patient	894332001S	1						1	Asthenia; Injection site hypersensitivity; Muscle spasms; Paraesthesia	FLU3~PFIZER\WYETH~4948100~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072518	02/07/1995	OH	40.0	40		F	11/07/1994	pt recvd flu vax & 1 day later, pt devel redness @ inj site;									Y	10/12/1994	10/13/1994	1		PVT	OTH	unk	unk		~ ()~~~In patient	894332002S	1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~4948100~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072519	02/07/1995	OH	59.0	58		F	11/16/1994	pt recvd flu vax & the next day pt reported soreness in the rt arm; 11 days p/inj pt exp weakness in the upper rt arm;									U	11/03/1994	11/04/1994	1		PUB	OTH	unk	NONE	NONE	~ ()~~~In patient	894332003S	1						1	Myalgia; Myasthenic syndrome	FLU3~PFIZER\WYETH~4948100~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072520	02/07/1995	IA				U	11/22/1994	pt recvd flu vax & 1 month later pt was treated for an abscess; pt was given Keflex & has been advised to receive physical therapy									U	10/23/1994				PUB	OTH	unk	unk		~ ()~~~In patient	894332004S	1						1	Abscess	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072521	02/07/1995	AZ	39.0			F	11/17/1994	pt recvd flu vax & 1 day later devel a red, raised rash @ inj site; pt also c/o itching, swelling, & tenderness @ inj site;									N	11/14/1994	11/15/1994	1		OTH	OTH	Synthroid	unk	pt has a history of hypothyroidism	~ ()~~~In patient	894332007S	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~4948148~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072522	02/07/1995	OK	40.0	40		F	11/15/1994	pt recvd vax 2 wks prev recvd SC in error 14NOV94; pt was to have recvd tuberculin test but it is believed that pt recvd flu vax instead; pt exp pain immed following the inj & devel erythema @ the inj site;				Y					Y	11/14/1994	11/14/1994	0		PVT	OTH	unk	unk		~ ()~~~In patient	894332008S	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~SC~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072523	02/07/1995	AL	50.0	50		F	11/10/1994	pt recvd flu vax & 2 wks later, pt c/o of lt arm pain w/limited ROM, & weakness in the lt hand;				Y					U	10/21/1994	11/04/1994	14		PUB	OTH	unk	unk	pt has been recommended for a neurology consult	~ ()~~~In patient	894332009S	1						1	Hypokinesia; Myasthenic syndrome; Pain	FLU3~PFIZER\WYETH~4948043~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072524	02/07/1995	OK	81.0	81		M	11/07/1994	pt recvd flu vax 31OCT94 & 7NOV94 devel fever (103.8 ax), chills, malaise, & muscle weakness; Medical Affairs comment: for those nine yrs of age 7 older, single dose of flu Shield is recommended;				Y					N	10/31/1994	11/07/1994	7		PVT	PVT	unk	unk		~ ()~~~In patient	894332010S	1						1	Chills; Malaise; Myasthenic syndrome; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072525	02/07/1995	NY				U	11/03/1994	pt recvd flu vax & devel redness, edema, & hardness @ inj site; Medical Affairs comment: inj was given SC; flu Shield is labelled for IM inj;									U					UNK	UNK	unk	unk			894332011S	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~SC~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072526	02/07/1995	NY				U	11/03/1994	pt recvd flu vax & pt devel redness, edema, & hardness @ inj site; Medical Affairs comment: inj was given SC; flu Shield is labelled for IM inj;									U					PVT	PVT	unk	unk		~ ()~~~In patient	894332012S	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~SC~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072527	02/07/1995	IN	81.0			M	11/02/1994	pt recvd vax & 16 hrs later, pt devel tingling in the lt arm; 2 wks later devel pain & weakness in the arm; pt was referred to a neurologist who found the ulnar & medial nerve to be affected & dx post vax neuropathy; tx Dexamethasone				Y					U	10/01/1994	10/02/1994	1		OTH	OTH		unk	unk	~ ()~~~In patient	894332013S	1						1	Myasthenic syndrome; Neuropathy; Pain; Paraesthesia	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072528	02/07/1995	NC	46.0	46		M	11/18/1994	pt recvd vax 17NOV94 & 2 days later on routine blood screening, pt was noted to have an elevation in CPK, LDh & AST (SGOT); pt was afeb & all other vital signs were WNL; pt was completely asymptomatic; pt had no tremors, rigidity, burises;									Y	11/17/1994				PVT	PVT	Klonopin, Haloperidol, Capoten, Procardia XL, Artane	unk	the pt has schizo-affective disorder, HTn, hypomania, & no known allergies;	~ ()~~~In patient	894333001S	1						1	Aspartate aminotransferase increased; Blood creatine phosphokinase increased; Blood lactate dehydrogenase increased	FLU3~PFIZER\WYETH~4948067~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072529	02/07/1995	MI	35.0	35		F	11/03/1994	pt recvd vax & w/in a few hrs, pt presented to ER w/an allerg react characterized by urticaria & rash (face, extremetries, & trunk); fullness in head; chest tightness; mild dyspnea; c/o sore throat & palpitations, rash, h/a given Claritin				Y					U	10/27/1994	10/27/1994	0		PUB	OTH	asthmacort; unspecified thyroid med; Moduretic	unk	pt has a hx of asthma & lupus (involving skin only);	~ ()~~~In patient	894333002S	1						1	Chest pain; Dyspnoea; Headache; Hypersensitivity; Palpitations; Pharyngitis; Rash; Urticaria	FLU3~PFIZER\WYETH~4948113~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072530	02/07/1995	CO	50.0			F	11/04/1994	pt recvd flu vax & several hrs later, devel a swollen lt wrist which felt warm to the touch; pt c/o aching which was not relieved by application of heat to the site;									U	10/31/1994	10/31/1994	0		OTH	OTH	unk	unk		~ ()~~~In patient	894333003S	1						1	Myalgia; Osteoarthritis; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0071370	02/08/1995	IN	53.0			F	01/25/1995	pt recvd vax; devel thrombocytopenia purpura the day p/ vax; pt died at end of dec94 or beginning of jan;MD does not know how thrombocytopenia presented;pt's daughter said,it was cause of death;	Y								N	09/29/1994	12/31/1994	93	n/s	PVT	OTH		none	none		34483	1						1	Thrombotic thrombocytopenic purpura; Oedema peripheral; Thrombotic thrombocytopenic purpura	FLU3~PARKE-DAVIS~00474P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00474P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Results in Death	Influenza
0071375	02/08/1995	TN	54.0	54		F	01/26/1995	pt recvd vax; next day, had chills,T 103;9cm red swollen area lt deltoid,central 12mm vesicle, slightly indented;prednisone,atb given;referred to MD for I&D & debridement of abcess;					Y				Y	11/11/1994	11/12/1994	1	none	PUB	OTH		na	meds, allergic to pcn, codeine;	~ ()~~~In patient		1						1	Chills; Injection site abscess; Injection site hypersensitivity; Injection site oedema; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0069003	02/09/1995	CA	63.0	63		M	02/01/1995					Y	Y	2			Y	11/16/1994	11/16/1994	0	EKG	PUB	UNK	Fosinopril	NONE	hypertension	NA~ ()~~~In patient		1						2	Unevaluable event	FLU3~PFIZER\WYETH~4948195~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0071379	02/09/1995	CA	37.0	37		F	01/24/1995	pt recvd vax;devel fever 101;myalgia,ha & noc sweats;stiff neck,swollen glands lt axilla;4th wk began to abate,devel pain over both eyes;c/o blurred vision,saw ophtalmologist who saw a central blind spot in rt eye dx:papilledema,cause vax				Y				Y	U	11/08/1994	12/14/1994	36	MRI nl; LP white cells in CSF, suggestive of meningitis; visual field testing--unspecified visual field defect;	PVT	PVT	none	unk	asthma--stable;	pt 20-30 years old had photophobia p/measles vax;~ ()~~~In patient	895027002A	1						1	Amblyopia; CSF test abnormal; Lymphadenopathy; Meningitis; Myalgia; Nuchal rigidity; Papilloedema; Visual field defect	FLU3~PFIZER\WYETH~4948195~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0071403	02/09/1995	MD	61.0	61		F	01/27/1995	17DEC94 @ about 12AM pt reports becoming violently ill--passing out for 1.5 hrs sick for days; seen family physician who arranged for testing;				Y					Y	12/15/1994	12/17/1994	2	tests were ordered in response to reaction to flu shot;	PUB	PUB	unk	sl cold-no fever	hx seixure disorder; hiatal hernia cerebral infarct rt parietal lobe	~ ()~~~In patient	MD95006	1						1	Malaise; Syncope; Malaise; Syncope; Vomiting	FLU3~PFIZER\WYETH~4948195~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4948195~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0058870	02/13/1995	MA	18.0	18		M	01/30/1995	pt recvd vax & 1 1/2 wks later devel fever, h/a, blurred vision; 1 wk later hospitalied & dx GBS & Bell's Palsy; pt states Bell's palsy caused by GBS; exp weakness in lt eyelid; hospitalized x 14 days;					Y	14			N	11/14/1993	11/24/1993	10		PVT	OTH	NONE	NONE		~ ()~~~In patient	895032002S	1						3	Amblyopia; Facial palsy; Guillain-Barre syndrome; Headache; Myasthenic syndrome; Pyrexia	FLUX~PFIZER\WYETH~4938160~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Hospitalisation	Influenza
0071426	02/13/1995	UT	60.0	60		M	01/27/1995	wife says flu like sx & SOB hospitalized for pneumonia 22NOV94 x 8 days; readmitted 04DEC94-expired 05DEC94; says had been on meds for kidney failure, HTN-autopsy revealed lung cancer;	Y	12/05/1994			Y				N	10/28/1994	11/03/1994	6		PUB	PUB	Tenex, Procardia, Furosemide, Aludent-Furoxaline	kidney failure, hip replace SEP94	Kidney failure, hip replacement SEP94, HTN, bilateral pulmonary emboli, mononeuritis multiplex w/muscle atrophy, mesangioglomerulonephritis 2ndary to IgM nephropathy, chronic leukocytosis & elevated creatinine; degenerative joint disease;	NONE~ ()~~~In patient	UT952703	1						1	Condition aggravated; Deep vein thrombosis; Hyperkalaemia; Lung neoplasm malignant; Pleural effusion; Pneumonia; Renal failure; Sepsis	FLU3~CONNAUGHT LABORATORIES~4F51072~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1474W~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Results in Death	Influenza
0071435	02/13/1995	MI	61.0	61		F		sick for about 4 wks w/migraine like h/a on same side as vax; lymph nodes greatly enlarged in armpit & neck on 24OCT94 on vax side, never did go back down; have not had a well day since shot, plus got vistula detachment in both eyes;				Y					N	10/19/1994	10/23/1994	4		UNK	PVT	Provera, Premarin	NONE felt great	chronic lymphocytic leukemia	NONE~ ()~~~In patient		1						1	Eye disorder; Lymphadenopathy; Malaise; Migraine	FLU3~PARKE-DAVIS~00374P~2~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0071440	02/13/1995	AK	62.0	61		F	02/01/1995	pt had laceration of finger & unk date of DT-so was given booster along w/flu shot @ pt's request; next seen 30NOV94 w/ c/o bilat pain mid-humerus & tenderness over deltoid insertion; pt request @ this time an adverse react form be filed;									N	08/30/1994				PVT	PVT	NONE	NONE	NONE	unk~ ()~~~In patient		1						1	Injection site pain; Myalgia; Pain	FLU3~PFIZER\WYETH~~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~UNKNOWN MANUFACTURER~4B61052~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|TTOX~CONNAUGHT LABORATORIES~TB5B61052~1~~LA~TETANUS TOXOID (NO BRAND NAME)~2	USA		Influenza
0071450	02/13/1995	MI	45.0	45		F	12/29/1994	devel h/a & palpations afternoon of 17OCT94, both became inc worse during evening, woke twice during noc severe h/a, inc palpations & vertigo, 4AM had unsteady gait from vertigo; forced fluids in AM around noon 18OCT94 sx began subsiding;									Y	10/17/1994	10/17/1994	0	NONE	PUB	PVT	Premarin	NONE	mitral valve prolapse	pt exp react 12 yrs ago w/flu vax #1 dose~ ()~~~In patient		1						1	Gait disturbance; Headache; Insomnia; Palpitations; Vertigo	FLU3~PFIZER\WYETH~4948111~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0071451	02/13/1995	MI	42.0	42		F	12/28/1994	22OCT94 nauseated, severe pain in inject site (lt deltoid), lasted approx 24 hrs; 21OCT94 hx of bronchial asthma, had difficulty w/asthma & needed to use Primetene nasal inhaler x4 p/inject;24OCT94 no redness or soreness in lt arm;									Y	10/21/1994	10/21/1994	0	NA	PUB	PVT	NONE	NONE	bronchial asthma as child	NONE~ ()~~~In patient		1						1	Condition aggravated; Injection site pain; Nausea	FLU3~PFIZER\WYETH~4948111~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0071452	02/13/1995	MI	39.0	38		F	12/29/1994	19OCT94 woke w/severe h/a, persisted all day, devel nausea-vomiting in PM that lasted thru out the noc; 20OCT94; h/a cleared, no vomiting but was nauseated;									Y	10/18/1994			NONE	PUB	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Headache; Nausea; Vomiting	FLU3~PFIZER\WYETH~4948111~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0071464	02/14/1995	MD	29.0	29		F	12/19/1994	pt recvd vax; approx 13 hrs later, arm became red, swollen, aching w/ a lump(size of a bee sting);1 day later, devel itching for approx 24-48 hrs;denies any hives, resp distress; c/o ha; has never recvd flu vax prior to this;									Y	12/14/1994	12/15/1994	1	none	PUB	UNK	loestrin;	none	bee stings, soaps;	none~ ()~~~In patient	MD94051	1						1	Myalgia; Oedema peripheral; Pruritus; Skin nodule; Vasodilatation	FLU3~PFIZER\WYETH~4948195~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0071470	02/14/1995	SC	14.0	14		F	12/08/1994	pt recvd vax;sl rash below inject site shortly p/ vax;no acute distress as SOB observed;dph  given; instructed to go ER if SOB devel;									U	12/02/1994	12/02/1994	0		PUB	UNK		none		~ ()~~~In patient	SC95010	1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~4948130~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0071474	02/14/1995	TN	61.0	61		F	01/04/1995	pt recvd vax; arm & joint pain;began approx 1 mo p/ vax;PC to MD who advised ice & some cream; says this was 1st & last shot;										11/10/1994	12/10/1994	30	none	PUB	PUB	premarin & zantac;		none	~ ()~~~In patient	TN95002	1						1	Arthralgia; Pain	FLU3~CONNAUGHT LABORATORIES~4F51165~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0071489	02/15/1995	NY				F	01/27/1995	pt recvd vax; 8 days later fell down & was unable to get up;taken to hosp & dx w/ encephalitis; pt was discharged; however, pt is in wheel chair;				Y	Y	27		Y	N	10/06/1994	10/14/1994	8		OTH	OTH	Synthroid 0.5 mg daily; Premarin vaginal cream bid;	unknown	Cervical carcinoma in 1965 w/total hysterectomy, thyroid carcinoma in 1986 tx w/radiation, arthritis affecting both hips, allergies	~ ()~~~In patient	895031002A	1						1	Anorexia; Asthenia; Blindness; Dizziness; Encephalitis; Hypokinesia; Malaise; Paralysis	FLU3~PFIZER\WYETH~4948120~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0071508	02/16/1995	MI	39.0	39		F	01/04/1995	pt recvd vax;pt claims 12 days later, became achey,chills,d,ha;no fever;so sick,could not get out of bed;lasted 48 hrs;first sxs 29nov94; fine by 1dec94;									Y	11/18/1994	11/29/1994	11		PUB	UNK	routinely takes tombocor for heart condition;	none		~ ()~~~In patient	MI95005	1						1	Chills; Diarrhoea; Headache; Myalgia	FLU3~CONNAUGHT LABORATORIES~4F51016~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0071510	02/16/1995	MI	60.0	60		M	01/11/1995	pt recvd vax;approx 1 wk later,devel pain leg;adm to hosp for blood clot; at home in 7days w/ coumadin;					Y	7			Y	10/05/1994	10/11/1994	6	visiting nurse does blood testing every wk;	PUB	PUB	vitamins	back pain, surgery 1985	went thru series of allergy shot for mold & oth things;	~ ()~~~In patient	MI95007	1						1	Jaundice; Pain; Peripheral vascular disorder; Thrombosis	FLU3~CONNAUGHT LABORATORIES~4F51165~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0071512	02/16/1995	MI	55.0	55		F	01/12/1995	pt recvd vax; arm became swollen, red, painful,itched;swelling & redness disappeared over 10-14 days; pain & tenderness still present especially w/ movements in arms;									N	11/05/1994	11/06/1994	1		PVT	PVT		none	pcn	~ ()~~~In patient	MI95009	1						1	Oedema peripheral; Pain; Pruritus; Vasodilatation; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4948110~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4948110~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0071521	02/17/1995	AR				F	02/08/1995	pt recvd vax 6NOV92 & subsequently devel transverse myelitis;								Y	N	11/06/1992				OTH	OTH	unk	unk		~ ()~~~In patient	895040001A	1						1	Myelitis	FLU3~PFIZER\WYETH~4928215~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0071535	02/17/1995	CT	76.0	76		F	01/30/1995	By 30OCT pt c/o h/a,; 3NOV joint pain; 4NOV difficulty standing; 5NOV loss of balance; 6NOV ER visit dx w/bladder infect sent home, 7NOV taken by ambulance to hosp w/convuls;			Y	Y	Y		Y	Y	N	10/28/1994	10/30/1994	2	meningitis;	PVT	UNK	Quinama, Perinactin	runny nose, ears stopped up & ringing		~ ()~~~In patient		1						1	Arthralgia; Convulsion; Coordination abnormal; Cystitis; Headache	FLUX~UNKNOWN MANUFACTURER~0145A~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0058205	02/21/1995	CA	61.0	61		M	05/23/1994	post vaccine GBS;			Y	Y	Y				N	10/27/1993	10/31/1993	4	EMG/NCV	OTH	OTH		hypertension	NONE	~ ()~~~In patient	CA95009	1						3	Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Life Threatening,Hospitalisation	Influenza
0071558	02/21/1995	NJ	71.0	71		M	02/03/1995	pt stated that 3 days p/vax 27OCT94 devel flu-like sxs lasting 3 days, felt better for 1 day & exp same sx; pt unable to get out of bed x 1 wk; hospitalized 11NOV94 x 14 days; dx kidney failure & GBS:					Y	14			U	10/27/1994	10/30/1994	3	Guillian Barre	PUB	PVT	NONE	denied	NONE	denied~ ()~~~In patient	NJ954	1						1	Guillain-Barre syndrome; Influenza; Renal failure	FLU3~CONNAUGHT LABORATORIES~4F51006~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0071576	02/21/1995	MD	61.0	61		F	02/14/1995	pt recvd vax at clinic;pt returned to clinic w/ some concern of rt arm at site of flu inject;expressed feelings of discomfort & aching in bones ever since recvd flu needle;has not consulted PMD;										12/19/1994				PUB	PUB	Diabeta;	weakness in left arm;	none	no~ ()~~~In patient	MD95005	1						1	Bone pain; Injection site pain	FLU3~PFIZER\WYETH~4948195~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0071738	02/22/1995	TX	68.0	68		F	11/09/1994	pt recvd vax; sick all over, rash, swelling at site; sore arm & neck;				Y						10/27/1994	10/31/1994	4		UNK	UNK				~ ()~~~In patient	TX95003	1						1	Injection site oedema; Malaise; Myalgia; Neck pain; Rash	FLU3~PFIZER\WYETH~4948146~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~4F6105~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0071750	02/22/1995	TX	43.0	43		F	02/06/1995	pt recvd vax; exp fatigue; general malaise, lt arm wakness & dec sensation; progressing to lt leg; hx of ha; oth areas, dec sensations; currently pt under tx;				Y					U	11/15/1994	12/01/1994	16	MRI, mylogram neg; testing cont;	OTH	PVT	dolabid;	none	NKA; 2 C sections;	unk~ ()~~~In patient	TX95018	1						1	Asthenia; Headache; Malaise; Myasthenic syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51006~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0071440	02/27/1995	AK	62.0	61		F	02/08/1995	deep, aching pain in both upper arms; started the day p/having vax in one arm & a flu shot in the other arm; pain has lasted 5 months, so far; taking muscle relaxants & anti-inflammatory meds;				Y					N	08/30/1994	09/01/1994	2	blood test for disease & x-rays showed no abnormalities;	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	AK9501A	1						2	Injection site pain; Myalgia; Pain	FLU3~PFIZER\WYETH~~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~UNKNOWN MANUFACTURER~4B61052~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|TTOX~CONNAUGHT LABORATORIES~TB5B61052~1~~LA~TETANUS TOXOID (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0071798	02/27/1995	WI	54.0	54		F	01/06/1995	pt recvd vax & the next day devel maculopapular, raised, erythematous rash of the face, neck, chest, back, abdo & extremties; itching, urticaria, erythema multiforme; rash;				Y	Y	14			Y	01/04/1995	01/05/1995	1		PVT	PVT	Lanoxin, Synthroid, K-DUR, Lasix, Lozol, Zestril, Allopurinol; unspecified chemotherapy 14DEC94	NONE	allergies: PCN, quinine (hives); pt has a hx of congestive heart failure, pulmonary hypersensitivity, intraventircular;	~ ()~~~In patient	895027002S	1						1	Erythema multiforme; Pruritus; Rash; Rash maculo-papular; Urticaria	FLU3~PFIZER\WYETH~4948053~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0071812	02/27/1995	CA	31.0	31		M	11/10/1994	fever 39.5, myalgias, arthralgias, wheezing; tx APAP, rest, albuterol treatment (inhalers); all outpatient tx;				Y					Y	10/26/1994	10/26/1994	0	NONE	PVT	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Arthralgia; Asthma; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~4F51060~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0071825	02/28/1995	OH	78.0	78		M	01/30/1995	9JAN seen by MD no known chronic med problems-devel acute onset of weakness in all 4 extremities depressed reflexes @ biceps, absent reflexes of the proximal leg weakness & difficulty getting up; poss category of inflam poly radiculopathy;				Y	Y	13	Y		Y	12/19/1994	01/08/1995	20	CSF-OWBC, 5RBC, glu 56, pro 68; GBS cont to progress	OTH	PVT	NONE	GBS	NONE	~ ()~~~In patient	OH95017	1						1	Asthenia; Guillain-Barre syndrome; Hyporeflexia; Myasthenic syndrome; Neuropathy	FLU3~PARKE-DAVIS~00474P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0071828	02/28/1995	CA	82.0	82		F	11/17/1994	unable to walk, disequilibrium; dx r/o MI					Y					11/10/1994				UNK	UNK			allergies PCN; hx of HTN, DM	~ ()~~~In patient		1						1	Coordination abnormal; Hypokinesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0071867	03/01/1995	WI	62.0	62		F	01/12/1995	pt recvd vax 27OCT94 & later noted numbness of entire lt arm; late in NOV got worse-lost grasp-dropped objects; able to feel hot/cold & pain; reported to MD; 19DEC94 because it didn't go away; presently same c/o some days worse than others;				Y					N	10/27/1994	11/04/1994	8	19DEC94 MRI-neg;	PUB	PUB	Dyazide, Dynacirc	NONE	breast CA, HTN	NONE~ ()~~~In patient	WI94111	1						1	Myasthenic syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4G51165~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0071874	03/01/1995	WI	59.0	58		F	12/21/1994	4 hrs p/vax pt exp an asthma attack, relieved by use of inhaler; also devel very red, swollen, purulent eyes, which continue to be red & swollen 18 hrs later;									Y	12/20/1994	12/20/1994	0	NONE	PUB	PUB		NONE	asthma attack 20 yrs ago; allergy to dogs;	~ ()~~~In patient	WI94119	1						1	Asthma; Conjunctivitis; Face oedema	FLU3~CONNAUGHT LABORATORIES~4F51165~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0071885	03/01/1995	MA	54.0	54		F	02/21/1995	pt began to feel pain in the back of lt thigh & into buttocks the afternoon p/shot; the pain inc to 3AM that noc & disappeared by morning-no treatment;									Y	10/13/1994	10/13/1994	0	NONE	OTH	OTH	Azmacort, Premarin, Uniphyll, Pred, Serevent		Asthma; allergic to dust, dust mites, birch, horses;	~ ()~~~In patient		1						1	Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0071889	03/02/1995	TN	74.0	74		M	02/06/1995	soreness in chest; like pleurisy; when take a deep breath, hurt in chest, sore; no fever; 7FEB95 pt talke w/MD who said in all probability flu shot had nothing to do w/illness; recent infect not cleared; MD put pt on Floxin starting 7FEB;									N	02/03/1995	02/03/1995	0	consulted MD by phone;	PUB	PUB	NONE	cold-mostly gone	Emphysema, allergic to chocolate	~ ()~~~In patient	TN95007	1						1	Chest pain; Pain	FLU3~CONNAUGHT LABORATORIES~4F51165~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0071891	03/02/1995	TX	82.0			M	01/20/1995	GBS post flu vax; pt recvd flu vax 1NOV94 & had a gradual onset of extremity weakness, lower>upper; pt seen by MD 14NOV w/weakness (0/5) in both lower limbs & extreme weakness in upper extremities; hyporeflexive also; PT in nearly 2mo hosp					Y					10/12/1994	11/14/1994	33		UNK	UNK			HTN, Glaucoma, BPH	~ ()~~~In patient		1						1	Faecal incontinence; Guillain-Barre syndrome; Hypokinesia; Hyporeflexia; Myasthenic syndrome; Urinary incontinence; CSF test abnormal; Faecal incontinence; Guillain-Barre syndrome; Hypokinesia; Myasthenic syndrome; Urinary incontinence	FLU3~PARKE-DAVIS~00184P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00184P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Hospitalisation	Influenza
0071893	03/02/1995	MI	64.0			F	02/24/1995					Y					Y					PVT	PVT		NONE	no allergies to chicken or eggs	pt exp severe myalgias w/bilat rt legs;~ ()~~~In patient		1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~4F51067~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~390966~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0072651	03/03/1995	MO	84.0	83		F	11/17/1994	pt recvd vax;fever 101.6, chills, n w/out v/d;HA;sxs lasted until next day;tx:apap & Motrin given;				Y					Y	10/20/1994	10/20/1994	0		PVT	PVT	nitroglycerine & ASA;	NA	angina,hiatal hernia, osteoarthritis, diverticulitis, Mastec;	~ ()~~~In patient		1						1	Chills; Headache; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51164~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0071959	03/07/1995	WY	36.0	35		F	02/01/1995	pt had a poss allerg react to flu vax in early DEC; relatives recall the day following vax pt was sick & throwing up; 2 days later ached all over & had diarrhea & then devel rash five to seven days later; rash turned more hive-like splotchy				Y					Y	11/21/1994	11/22/1994	1		OTH	PUB	Proventil inhaler, synthroid, Valproic Acid, Zoloft, APAP	Hypothroidism, depression, asthma, sz di	allergic to ASA, phenbarb MS, Streptomycin, PCN, Keflex, Codeine, DIlantin; Hypothroidism, depresstio, asthma, sz disorder, lo mental capacity	~ ()~~~In patient		1						1	Diarrhoea; Hypersensitivity; Myalgia; Rash; Urticaria; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51165~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0071987	03/09/1995	CO	72.0	72		F	11/10/1994	pt recvd vax;glands under arms,began to swell 2 days later;severe aching of back & shoulder (rt);to MD,felt it was rxn to flu vax;sxs resolved;				Y					Y	10/10/1994	10/12/1994	2		OTH	PUB	none	none	propylene glycol (rash)	~ ()~~~In patient	CO95003	1						1	Back pain; Lymphadenopathy; Myalgia	FLU3~CONNAUGHT LABORATORIES~4F51165~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0071988	03/09/1995	CO	34.0	34		M	10/27/1994	pt recvd vax;pt reported feeling dizzy;rested for approx 10 mins,but cont to feel badly;c/o hot & n;felt cold & c/o difficulty breathing;epinephrine given,911 called;P rate =120;to er;pt reported feltwiped out;body aches & fatigue;				Y					Y	10/26/1994	10/26/1994	0		OTH	PUB	none	none	smoker	~ ()~~~In patient	CO95004	1						1	Asthenia; Chills; Dizziness; Dyspnoea; Myalgia; Nausea; Pyrexia; Tachycardia	FLU3~CONNAUGHT LABORATORIES~4F51146~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0071989	03/09/1995	CO	24.0	24		F	11/29/1994	pt recvd shot (NOV & 11NOV face became swollen, eye hurt & 14NOV mouth crooked, eye closed & drooping & difficult to eat; & seen @ urgent care; dx bell's palsey; recvd prescription; 22NOV sx resolved;				Y					Y	11/09/1994	11/11/1994	2	NONE	OTH	PUB	NONE	NONE	NONE	~ ()~~~In patient	CO95005	1						1	Eye pain; Eyelid ptosis; Face oedema; Facial palsy	FLU3~CONNAUGHT LABORATORIES~4F51152~1~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0071990	03/09/1995	CO	45.0	45		M	12/09/1994	27OCT recvd vax in rt deltoid; 12NOV began exp join pain rt shoulder, hand elbow; 25NOV consulted w/MD dx rheumatoid arthritis; 28NOV retunr to MD c/o sore throat-typ B step throat-tx w/PCN x 10 days;				Y					N	10/27/1994	11/12/1994	16	Blood smapled, xray	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	CO95006	1						1	Arthralgia; Infection; Pharyngitis; Rheumatoid arthritis	FLU3~CONNAUGHT LABORATORIES~4F51146~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0072004	03/09/1995	TX	53.0	53		F	03/07/1995	5 days p/vax pt exp swelling rt side of face, eye, rt chin, cheek & rt side of tongue; later in day had hives all over body; took DPH had reaction-throat swelling; went to ER;				Y						11/07/1994	11/13/1994	6		PUB	PUB	NONE	NONE	NONE	NA~ ()~~~In patient	TX9537	1						1	Face oedema; Laryngospasm; Tongue oedema; Urticaria	FLU3~PARKE-DAVIS~00374P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0072006	03/09/1995	OH	45.0	45		F	01/27/1995	nl discomfort w/initial inj- became inc painful over several days; severe pain radiating down into arm & hand w/inc activity of arm; went to MD in JAN95; placed on ATB & is to begain PT				Y					U	10/13/1994	10/15/1994	2	NONE	PVT	PVT	Xanax, Procardia, Vitamins	NONE	NKA-coronary artery spasm, cyst on brain	NONE~ ()~~~In patient		1						1	Pain	FLU3~PFIZER\WYETH~4948100~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072023	03/13/1995	CA	52.0	52		M	12/19/1994	pt reported that had shallow breathing & a feeling of tightness in chest; also stated that had been coughing up yellow phlegm; diff breathing;				Y					Y	12/14/1994	12/15/1994	1	NONE	PUB	PUB	NONE	pt states that was well	hx of asthma	NONE~ ()~~~In patient	CA95030	1						1	Chest pain; Cough; Dyspnoea; Hypoventilation	FLU3~CONNAUGHT LABORATORIES~4F51060~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0072964	03/13/1995	MN	34.0	34		M	11/18/1994	pt recvd vax;immed p/wards exp dull achy pain in shoulder joint;6 hrs later,noticed dec range of motion which limited use of arm;significant pain;orthopedic surgeon dx a frozen joint & prescribed non-steroidal anti-inflammatory therapy;									N	10/11/1994	10/11/1994	0		PUB	PVT		none		~ ()~~~In patient	894332005S	1						1	Arthralgia; Arthropathy; Hypokinesia; Pain	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~PFIZER\WYETH~~UNK~IM~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0074594	03/17/1995	NY				F		pt recv vax; exp n, fatigue & numbness in her fingers & legs; MD believed sx were caused by Hep B vax (given in 1988);									U	09/01/1994	12/25/1994	115		OTH	OTH				~ ()~~~In patient	WAES95010045	1						1	Asthenia; Infection; Nausea; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0072106	03/20/1995	NY	70.0	70		F	02/28/1995	pt recvd vax;devel GBS;				Y	Y	40			N	10/11/1994	10/28/1994	17		PUB	OTH	Propanolol;		COPD, hypertension, allergic to sulfa drugs;	unk~ ()~~~In patient	895066001A	1						1	Arthralgia; CSF test abnormal; Condition aggravated; Guillain-Barre syndrome; Myasthenic syndrome; Myelitis; Neuropathy; Paraesthesia	FLU3~PFIZER\WYETH~4948120~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0072113	03/20/1995	AR	42.0	42		F	12/01/1994	pt recvd vax;c/o pain in rt deltoid area the noc of vax;pain cont x 1 wk w/ limited mobility noted of rt arm;no swelling/redness;to PMD;tx w/ anti-inflam meds x 10 days w/ almost complete recovery;				Y					Y	10/17/1994	10/17/1994	0	none	PUB	PUB	none	none	none	none~ ()~~~In patient	AR9513	1						1	Hypokinesia; Injection site pain	FLU3~CONNAUGHT LABORATORIES~4F51016~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0072130	03/20/1995	SD	53.0	53		M	03/06/1995	pt recvd vax; chest x-ray were positive for pneumonia;tx in hsp w/ IV ATB's;				Y	Y	18			Y	11/07/1994	12/12/1994	35	chest x-ray pos for pneumonia;	PVT	PVT	apap#3,hytrin,soma,zoloft,pepcid;	none	sulfa-asa, numerous med conditions;	~ ()~~~In patient	SD95010	1						1	Drug ineffective; Infection; Pneumonia	FLU3~PFIZER\WYETH~4948100~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~366962~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0071370	03/31/1995	IN	52.0	52		F	03/13/1995	pt recvd vax; c/o hands swelling 30sep94; death due to thrombocytopenia;	Y	01/06/1995							N	09/29/1994	09/30/1994	1		OTH	PVT				~ ()~~~In patient		1						2	Thrombotic thrombocytopenic purpura; Oedema peripheral; Thrombotic thrombocytopenic purpura	FLU3~PARKE-DAVIS~00474P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00474P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Results in Death	Influenza
0072624	03/31/1995	NM	69.0	69		M	02/27/1995	pt recvd vax; reddened area w/ lots of tenderness & warm to elbow inject site;				Y					Y	02/08/1995	02/08/1995	0	none	PUB	PUB	lisinopril, tolazamide;	seen for NIDDN/HTN good control	NIDDN, colon Ca; HTN; glacoma;	none~ ()~~~In patient	NM95005	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4948197~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0433A~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0072643	03/31/1995	VA	56.0	56		F	03/17/1995	pt recvd vax;severe asthma,sinusitis infect, whelps,rash on legs & arms;still under MD's care;sick since 29jan95;not responding to tx;tx:atb's,pred & 2 kinds of inhalers;			Y	Y					N	01/23/1995	01/28/1995	5	CXR	PVT	UNK	none	none		~ ()~~~In patient		1						1	Asthma; Rash; Sinusitis; Urticaria	FLU3~PFIZER\WYETH~4948115~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~390935~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Life Threatening	Influenza
0072675	03/31/1995	MA	24.0	24		F	01/23/1995	fatigue, low grade fever, nausea, dizziness, muscle & joint pain, weakness; sx began on 11NOV94 & worsened till 27DEC94- when pt able to get out of bed; since then they have improved sl, but still unable to work;				Y					N	11/10/1994	11/11/1994	1	weak pos for mononucleosis; all other tests nl	OTH	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Arthralgia; Asthenia; Dizziness; Lymphocytosis; Myalgia; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51088~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0072722	03/31/1995	WI	41.0	41		M	11/15/1994	flushing; nausea; pt has porphyria & has exp similar;									Y	10/19/1994			NA	PVT	UNK		porphyria-no acute illness	coproporphyril	~ ()~~~In patient		1						1	Nausea; Vasodilatation; Arthralgia; Nausea	FLU3~PFIZER\WYETH~4948130~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4948130~3~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0072723	03/31/1995	WI	53.0	53		F	11/11/1994	vertigo, severe on 26OCT, 27, 28; evaluated by MD 4NOV94; treated w/meclizine				Y						10/15/1994	10/26/1994	11	NONE	PVT	PVT	Estrogen, Progesterone, Chlorpheneramine, Amitryptilline	NONE	allergies to pollens, fibrocystic disease (breast); headaches;	~ ()~~~In patient		1						1	Vertigo	FLU3~PFIZER\WYETH~4948130~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072724	03/31/1995	WI				F	11/15/1994	vertigo starting on 31OCT severe on 2NOV94 eval by MD on 3NOV94 rx Lorazepam; dizziness resolved 5NOV94;									Y	10/17/1994	10/31/1994	14	NONE	PVT	PVT	Lorazepam-no other rx currently		asthma; duodual ulcers	~ ()~~~In patient		1						1	Dizziness; Vertigo	FLU3~PFIZER\WYETH~4948130~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0072725	03/31/1995	WI	71.0	71		M	11/27/1994	pt sent letter w/following account-difficulty in walking from clinic to car, diaphoresis; p/eating breakfast, devel the runs; several days later devel ha/ @ base of skull, in bed for 6 days; pain spread into back & hips; neck stiff;									Y	10/17/1994	10/17/1994	0	NONE	PVT	PVT	ASA; Norvasc; Atenolol; Lopid, Probenecid	yearly exam	muscular dystrophy, post MI, hyperlipidemia, gout;	NONE~ ()~~~In patient		1						1	Arthralgia; Back pain; Diarrhoea; Gait disturbance; Headache; Hyperhidrosis; Neck pain; Nuchal rigidity	FLU3~PFIZER\WYETH~4948130~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~382958~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0072907	04/04/1995	MS	71.0	71		F	03/07/1995	pt recvd vax; started feeling bad,getting weak,no appetite,woke up w/ swelling & redness of face;marked swelling of upper eyelids & face w/ erythema;					Y					01/23/1995	01/25/1995	2	none	UNK	UNK			sulfa	~ ()~~~In patient		1						1	Anorexia; Asthenia; Face oedema; Malaise; Rash; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0072970	04/05/1995	OH	65.0	65		F	03/31/1995	pt recvd vax;devel stinging & numbness in shoulder & arm;in er;elev BP & hyperventilation;dx not done yet;pt said cardiac problems have been ruled out; pt believes has nerve damage from flu vax;				Y					U	10/24/1994	11/01/1994	8	MRI	PUB	PUB	procardia	none	hypertension	none~ ()~~~In patient	OH95036	1						1	Condition aggravated; Hypertension; Hyperventilation; Neuropathy; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51016~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0073003	04/07/1995	MN	52.0	52		F	12/05/1994	pt recvd 01DEC94 1030AM  & exp coughing, couldn't clear throat, felt like something was stuck in throat, coughed so hard vomited; also noticed chest pressure; TPR 330PM 100.3-108; also noticed chest pressure; BP 180/82; viral synd & angina;					Y	1			Y	12/01/1994	12/01/1994	0		PVT	PUB	Cardizen, Lopid, Calcan, B12	NONE	allergic to sulf, PCN, Codeine, hx PRN metal angina	NONE~ ()~~~In patient	MN94051	1						1	Angina pectoris; Chest pain; Cough; Hypertension; Infection; Pyrexia; Tachycardia; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51087~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SMITHKLINE BEECHAM~1406A4~1~IM~LA~HEP B (ENGERIX-B)~1	USA	Hospitalisation	Influenza
0073004	04/07/1995	MN	66.0	66		M	11/14/1994	pt recvd vax in AM & by the evening & the following 2 days exp chills & warmth off & on; devel 10 red streak which was warm in rt arm; streak went from inj site down to elbow lasted 1 wk;				Y					Y	10/28/1994	10/28/1994	0	NONE	PUB	PUB	unk	NONE	unk	unk~ ()~~~In patient	MN94052	1						1	Chills; Skin striae; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51165~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~4B61052~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0073005	04/07/1995	MN	24.0	24		F	11/22/1994	By the time pt reported situation to nurse was feeling fine; reported by pt queasy few mins p/vax; started seeing blotches, felt faint; very light-headed; throat started swelling & tongue became numb; felt heat beat inc;									Y	10/04/1994	10/04/1994	0		OTH	UNK	NONE	NONE	NONE	~ ()~~~In patient	MN94053	1						1	Dizziness; Laryngospasm; Nausea; Paraesthesia oral; Tachycardia; Visual disturbance	FLU3~PFIZER\WYETH~4948119~1~A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0073006	04/07/1995	MN				F	11/23/1994	pt recvd vax @ 1130 am heart palpitations started @ 1145 am BP 100/70, P64, R20; hx of palpitations from 15 mins to 1 hr;										11/23/1994	11/23/1994	0		UNK	UNK			hx of palpitations	~ ()~~~In patient	MN94054	1						1	Condition aggravated; Palpitations	FLU3~PFIZER\WYETH~4948122~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0073007	04/07/1995	MN	19.0	19		M	11/23/1994	pt recvd vax 15mins later onset of feeling spaced out, diaphoretic, shaking, dizzy; chest pain; blurred vision; called 911; paramedics eval -pt stable; pt refused transport; girlfriend took pt home; no problems										11/03/1994	11/03/1994	0		OTH	UNK		NONE		~ ()~~~In patient	MN94055	1						1	Chest pain; Depersonalisation; Dizziness; Hyperhidrosis; Tremor; Visual disturbance	FLU3~PFIZER\WYETH~4948122~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0073008	04/07/1995	MN				F	11/23/1994	apporx 10 mins following vax pt reported tingling in mouth & up to bridge of nose; just don't feel nl; BP 140/90;										10/14/1994	10/14/1994	0		OTH	UNK	Premarin, Robaxin	NONE		~ ()~~~In patient	MN94056	1						1	Hypertension; Paraesthesia oral; Personality disorder	FLU3~PFIZER\WYETH~4948122~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0073009	04/07/1995	MN				M	11/23/1994	about 10-15mins p/vax pt reported difficulty swallowing; BP 158/120; EMS called & transported pt to ER; Adrenaline administered; BP came down to 152/84, diff in swallowing subsided;				Y					Y	10/05/1994	10/15/1994	10		OTH	UNK	NONE	NONE		~ ()~~~In patient	MN94057	1						1	Dysphagia; Hypertension	FLU3~PFIZER\WYETH~4948122~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0073010	04/07/1995	MN	18.0	18		F	11/23/1994	lightheaded, back pain, nauseated, chills-onset 2 hrs p/inj; pt went home felt well enough to drive;										11/23/1994	11/23/1994	0		OTH	UNK		NONE	NONE	~ ()~~~In patient	MN94058	1						1	Back pain; Chills; Dizziness; Nausea	FLU3~PFIZER\WYETH~4948122~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0073011	04/07/1995	MN	31.0	31		M	11/21/1994	w/in 10 mins p/vax pt exp feeling of change & breathing faster & inc shallow; 15 mins post vax got cold sweats; 20 mins post vax back to RN & dizzy & clammy, face flushed, inj site red & diameter of baseball; monitored for next 30 mins;									Y	10/18/1994	10/18/1994	0	BP 156/96, 146/82 poss hypertension;pulse 108-92	OTH	PVT	NONE	NONE	NONE- poss undx'd hypertension	~ ()~~~In patient	MN94059	1						1	Dizziness; Hyperhidrosis; Hypertension; Hyperventilation; Injection site hypersensitivity; Tachycardia; Vasodilatation	FLU3~PFIZER\WYETH~4948122~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0073012	04/07/1995	MN	61.0	61		F	11/28/1994	2 hrs post vax returned to clinic w/ c/o pain lt arm & across upper chest; exp heart palpitations in the evening & temp of 103; next day kept in phone contact w/pt thru the weekend plus called MD;									Y	11/18/1994	11/18/1994	0	NONE	OTH	PVT	Zantac		hyper-acid stomach & liver weakness;	~ ()~~~In patient	MN94060	1						1	Chest pain; Pain; Palpitations; Pyrexia	FLU3~PFIZER\WYETH~4948122~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0073013	04/07/1995	MN				F	11/28/1994	nausea, dizzy, faint, BP 90/50, 100/70 cold rag applied to forehead & back of neck, sitting head low, monitored BP, offered fluids-juice; left work;									Y	11/05/1994	11/05/1994	0		UNK	UNK	NA			~ ()~~~In patient	MN94061	1						1	Dizziness; Hypotension; Nausea	FLU3~PFIZER\WYETH~4948122~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0073014	04/07/1995	MN				F		diaphoretic & light-headed; BP 88/52, 110/50;										10/05/1994	10/05/1994	0		UNK	UNK	NONE		family history (aunt & grandparents) had flu shot reactions	~ ()~~~In patient	MN94062	1						1	Dizziness; Hyperhidrosis; Hypotension	FLU3~PFIZER\WYETH~4948122~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0073015	04/07/1995	MN				F	11/28/1994	event occurred @ flu clinic pt c/o blurred vision, head throbbing, nausea & fainted 2 times, sustaining small abrasion over lt eyebrow 105PM;									Y	10/17/1994	10/17/1994	0	NA	UNK	UNK	NONE		NONE	~ ()~~~In patient	MN94063	1						1	Headache; Injury; Nausea; Syncope; Visual disturbance	FLU3~PFIZER\WYETH~4948122~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0073016	04/07/1995	MN	30.0	30		M	11/28/1994	onset of dizziness & inc BP 30 mins p/shot; 210PM BP 144/100, P88; 215PM BP 140/90, P92; 220PM back to work advised to f/u w/BP w/MD will eat in 2 hrs to stabilize diabetic blood sugar;										10/04/1994	10/04/1994	0		UNK	UNK			diabetes-diet controlled	~ ()~~~In patient	MN94064	1						1	Dizziness; Hypertension; Tachycardia	FLU3~PFIZER\WYETH~4948122~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0073017	04/07/1995	MN				M	11/28/1994	started feeling spaced out & boxed in 10 mins p/shot; presented to ofc 20 mins p/shot; BP 118/82, P80, R20; went to eat @ 1300, to return if further problems;									Y	10/04/1994	10/04/1994	0	NONE	OTH	UNK	NA		NA	~ ()~~~In patient	MN94065	1						1	Depersonalisation	FLU3~PFIZER\WYETH~4948122~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0073021	04/07/1995	MN	37.0	37		F	11/08/1994	pt became weak & faint like sx followed by nausea & vomiting; EMT services were @ clinic site applied 02 PRN;				Y					Y	11/04/1994	11/04/1994	0		PUB	PUB	Mantoux by Connaught lot# 238211 4NOV94	NONE		~ ()~~~In patient	MN94069	1						1	Asthenia; Dizziness; Nausea; Vomiting	FLU3~PFIZER\WYETH~4948045~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0073022	04/07/1995	MN	26.0	25		F	11/08/1994	pt recvd vax & exp hoarseness, chest pressure (felt like a couple bricks on chest; fatigued & icky that evening; next day still felt fatigue & dizziness by 3rd day was ok; has hx of hypertension									Y	10/28/1994	10/28/1994	0	NONE	OTH	OTH	NONE	NONE	hypertension	~ ()~~~In patient	MN94070	1						1	Asthenia; Chest pain; Dizziness; Dysphonia; Malaise	FLU3~PFIZER\WYETH~4F51022~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0073025	04/07/1995	SC				F	03/29/1995	pt recvd vax; ultrasound evidence of congenital cystic; adenomatoid malformation of the lungs; bilaterally of fetus at 18-5 wks 25oct94;LMP of patient 25oct94														UNK	UNK			flu vax given to pt shortly p/ getting pregnant;	~ ()~~~In patient		1						1	Foetal disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0073066	04/10/1995	CA	60.0			M	03/31/1995	pt recvd vax; Guillain barre synd; onset 1st wk of dec;				Y					Y	10/19/1994	12/01/1994	43	nerve conduction studies;	OTH	UNK		none	none	~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~90724~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0073100	04/11/1995	WI	89.0			M		pt recvd vax & devel diarrhea; @ the time of this report diarrhea persisted; No further details were provided;														UNK	UNK			no relevant history	~ ()~~~In patient	WAES94120228	1						1	Diarrhoea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0073183	04/13/1995	WA	45.0	45		F	01/20/1995	pt recvd vax; inj site is hard, red & sore;? fever,swelling 5-6 all around site;severe sxs were relieved w/ apap;Ibuprofen taken for anoth problem;										01/18/1995	01/18/1995	0		PUB	PUB	Ibuprofen	denies	denies	~ ()~~~In patient	WA951087	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51153~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~380957~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0073201	04/13/1995	WA	57.0	57		M	12/16/1994	pt recvd vax; rash,small red spots on back,chest, shoulders;using calamine lotion;very itchy,dph suggested;has many allergies;				Y					N	11/07/1994	11/09/1994	2	19dec94 no better, to see MD;	OTH	OTH	none	none	mult allergies;	~ ()~~~In patient	WA951104	1						1	Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0073313	04/18/1995		50.0			M	03/31/1995	pt devel palpable, purpuric lesions over lower extremities; also exp pain in the proximal interphalangeal joints of the lt 2nd & 3rd digits unassoc w/swelling or erythema; skin biopsy of one purpuric lesion revealed focal areas of necrosis					Y				Y		08/01/1991		AUG91 CBC-no EOS; UA-nl; skin biopsy of one of the purpuric lesions-focal areas of necrosis & neutrophilic infiltrate in the epidermis & fibrinoid necrosis of the vessels seen in the papillary & upper reticular dermis	OTH	OTH	NA	NA	Gout	NS~ ()~~~In patient	35623	1						1	Abdominal pain; Arthralgia; Chest pain; Diarrhoea; Haemorrhage; Purpura; Skin necrosis; Vasculitis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0073314	04/18/1995		60.0			M	03/29/1995	pt exp fever, dry cough, chills, calf pain, fatigue, rigors & maculopapular rash devel on limbs; lab features revealed HGB, WBC & ESR were above upper limits of nl w/rt upper lobe infiltrate; liver enzymes & kidney func nl;dx vasculitis;					Y				Y		10/01/1991		C2 sl depressed while C4 nl; protein electrophoresis showed diffuse gamma globulin elevation;	OTH	OTH	NS	NS	polymyalgia rheumatica	pt exp fever, dry cough, myalgia, fatigue @ 59 y/o Fluogen~ ()~~~In patient	35555	1						1	Immunoglobulins increased; Laboratory test abnormal; Leukocytosis; Necrosis; Polyarteritis nodosa; Rash maculo-papular; Red blood cell sedimentation rate increased; Vasculitis	FLU3~PARKE-DAVIS~~2~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0073315	04/18/1995		66.0			F	09/15/1994	pt adm to hosp w/severe myalgia of both calves, fever, noc sweats, malaise & fatigue; devel weakness of hip flexors; hemoglobin was 12 G/L, leukocytosis was 13,000 MM E 3, ESR was 90 MM/H, AST sl elevated; erythrocyturia & proteinuria 0.42;					Y				Y	08/01/1990	09/01/1990	31	rt lower lobe infiltrate a small bilateral pleural effusion; kidney biopsy showed fibrinoid necrosis of medium sized vessels & necrotizing glomerulonephritis; calf biopsy showed necrosis & an inflammatory infiltrate w/in a medium sized art	OTH	OTH	NS	NS	NS	NS~ ()~~~In patient	32215	1						1	Albuminuria; Glomerulonephritis; Haematuria; Necrosis; Pleural effusion; Polyarteritis nodosa; Red blood cell sedimentation rate increased; Vasculitis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0073324	04/18/1995	AL	55.0	55		M	04/06/1995	pt devel mild peripheral polyneuropathy p/flu vax;									N	10/18/1994	11/01/1994	14		OTH	OTH	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Neuropathy	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0067912	04/24/1995	MO	34.0	34		F	03/29/1995	pt recvd vax & exp pruritus @ inj site @ 2mins then w/difficulty catching breath;				Y					Y	10/23/1994	10/23/1994	0	NONE	PVT	OTH	NONE	NONE	amoxicillin, Inovar	unk~ ()~~~In patient		1						2	Dyspnoea; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0073398	04/24/1995	CA	45.0	45		F	02/21/1995	pt visiting parent & became ill w/severe retching & vomiting, but no nausea; also had weakness & dizziness so severe that could not open eyes; had broken blood vessels in sclera & around eyes; devel blood in emesis; seen @ ER;				Y					Y	11/01/1994	11/16/1994	15	nl EKG, chem & coag panels, nl cath urine w/C&S, nl CXR; emesis guiac pos; stool guiac neg;	OTH	PUB	TIclio, ASA, Keflex Glyburide, Elavil, NPH insulin, Baclofen & vitamins	NONE	diabetes, neuropathy, neuritis; allergies Damasone, Zostrix, Neosporin ointment	~ ()~~~In patient	CA95048	1						1	Angiopathy; Asthenia; Dizziness; Gastrointestinal haemorrhage; Haematemesis; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51025~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0073451	04/24/1995	MS	53.0	53		F	04/14/1995	soreness & vaginal blisters; to MD; dx herpes;				Y					N	11/05/1991	11/12/1991	7		PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	MS95017	1						1	Herpes simplex; Vaginal infection	FLUX~PFIZER\WYETH~4918153~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0074696	04/25/1995	AZ	34.0	34		F	01/30/1995	pt recv vax & later in the day devel achiness @ the inj site; approx 2 wk later began to exp a tingling sensation across shoulders & down both arms; felt fatigued & fingers felt stiff; ANA titer was elevated;									Y	10/01/1993	10/01/1993	0	ANA titer elevated	PVT	OTH	lo/ovral	NONE		NA~ ()~~~In patient	895053004S	1						1	Amblyopia; Antinuclear antibody; Asthenia; Hypertonia; Injection site pain; Lymphadenopathy; Paraesthesia; Photophobia	FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0071403	05/01/1995	MD	61.0	61		F	03/01/1995	vomiting (violently ill), passed out (1.5 hr), feeling sick (for days);				Y					Y	12/15/1994	12/17/1994	2		PUB	PUB	unk	sl cold	hx of sz DO; hiatal hernia; cerebral infarct rt parietal lobe	NA~ ()~~~In patient	895095001S	1						2	Malaise; Syncope; Malaise; Syncope; Vomiting	FLU3~PFIZER\WYETH~4948195~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4948195~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0071512	05/01/1995	MI	55.0	55		F	01/05/1995	pt recv vax & w/in 24 hr devel swelling, tenderness & redness in the upper lt arm (from elbow to shoulder), which persisted for several wk; As of the date of this report, swelling & redness have resolved but pt cont to c/o arm pain				Y					N	11/01/1994	11/01/1994	0		PVT	PVT	Cardizem, Flagyl	jaw infect	pt had dental surgery in October 94 followed by infect in lower jaw & lt side of neck-tx unspecified ATB; devel unspecified bowel problems & tx Flagyl	~ ()~~~In patient	895033001S	1						2	Oedema peripheral; Pain; Pruritus; Vasodilatation; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4948110~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4948110~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0074697	05/01/1995	NJ	17.0	17		M	01/16/1995	pt recv vax & approx 2 months later devel pneumonia & was hospitalized; p/unspecified testing, was dx w/influenza type A; tx & length of hospitalization were not specified; pt has been discharged from the hosp					Y				Y	10/26/1994	01/01/1995	67		OTH	PVT	PEN VK	sickle cell anemia	allergic to erythromycin & morphine	NA~ ()~~~In patient	895018002S	1						1	Drug ineffective; Infection; Pneumonia	FLU3~PFIZER\WYETH~4948117~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0074698	05/01/1995	FL	79.0	79		M	01/25/1995	pt recv vax & 5 days later, devel a viral synd which progressed to bilateral weakness in the lower & upper extremities, difficulty walking secondary to unsteadiness in gait, delayed nerve conduction;				Y				Y	N	10/03/1994	10/08/1994	5	EMG-motor & sensory polyneuropathy; chemistory, B-12 & folate levels are nl;	PVT	PVT	Glynase, Prinivil	NONE	pt has a hx of diabetes, osteoarthritis & hypertension	~ ()~~~In patient	895045001S	1						1	Asthenia; Gait disturbance; Hypokinesia; Infection; Laboratory test abnormal; Myasthenic syndrome; Neuropathy	FLU3~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0074699	05/01/1995	WI	12.0			M	01/19/1995	pt recv vax & devel a dermatographic rxn; pt is being treated w/Hismanal, Pepcid, Hydorxyzine				Y					U					OTH	OTH	unk	unk		NA~ ()~~~In patient	895026002S	1						1	Urticaria	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0074700	05/01/1995	PA				M	01/17/1995	pt recv vax & approx 6 wk later devel a nodule of the rt axilla, which was dx as a foreign body granuloma;									U	11/09/1994	12/23/1994	44		PVT	OTH	unk	unk		NA~ ()~~~In patient	895026003S	1						1	Granuloma; Skin nodule	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0074701	05/01/1995	PA	38.0			F	01/17/1995	pt recv flu vax & 6 wk later devel Bell's Palsy, affecting the lt side of the face; pt's otolaryngologist began tx 13JAN95 w/decreasing doses of Pred;				Y					U	11/01/1994	01/01/1995	61		OTH	OTH	unk	NONE		pt exp an episode of Bell's Palsy last yr w/flu vax~ ()~~~In patient	895027001S	1						1	Facial palsy	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0074703	05/01/1995	NY				U	01/27/1995	pt recv vax & devel palsy of the sixth nerve; sx included h/a, confusion, & double vision; The reporting MD indicated that the pt was referred by an internist, dx was based on taking the pt's hx & questioning the pt				Y					U					OTH	OTH	unk	unk		~ ()~~~In patient	895046001S	1						1	Confusional state; Diplopia; Headache; Ophthalmoplegia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0074704	05/01/1995	NY				U	01/27/1995	pt recv vax & devel palsy of the sixth nerve; sx included h/a, confusion, & double vision; reporting MD indicated that the pt was referred by an internist, & dx was based on taking the pts hx & questioning the pt;				Y					U					OTH	OTH	unk	unk		~ ()~~~In patient	895046002S	1						1	Confusional state; Diplopia; Headache; Ophthalmoplegia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0074705	05/01/1995	NY				U	01/27/1995	pt recv vax & devel Bell's Palsy; sx included h/a, confusion, & double vision; reporting MD indicates that the pt was referred by an internist, dx was based on taking the pt's hx & questioning the pt;				Y					U					OTH	OTH	unk	unk		~ ()~~~In patient	895046003S	1						1	Confusional state; Diplopia; Facial palsy; Headache	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0074706	05/01/1995	AK	35.0			F	01/31/1995	pt recv vax & 20 mins later devel pain @ inj site & several days later had bruising; the pt also reported a matching small bruise in the rt clavicular area, lateral to the inj site; pt describes inj as being placed high in upper arm;				Y					U	11/10/1994	11/10/1994	0	x-ray (upper arm) nl;	OTH	OTH	NONE	unk		~ ()~~~In patient	895047001S	1						1	Ecchymosis; Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0074707	05/01/1995	WA	68.0	68		F	02/07/1995	pt recv vax & several wk later, noticed a lump @ inj site; pt's MD had an x-ray performed & referred to an orthopedic surgeon; pt stated that the surgeon told her that has a mass in muscle; probably due to flu vax;				Y					N	11/20/1994	12/01/1994	11		PVT	OTH	Diabeta, Capoten	NONE	pt has a hx of diabetes & HTN	NA~ ()~~~In patient	895053003S	1						1	Injection site mass	FLU3~PFIZER\WYETH~494804~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0074708	05/01/1995	NH	50.0			F	02/07/1995	pt recv vax & later that day exp soreness (w/o skin rxn) @ inj site & flu-like sx; approx 1FEB95 three blisters devel @ the inj site which the reporting MD thought could be delayed hypersensitivity rxn (no tx prescribed); c/o arthralgia;				Y					U	10/24/1994	10/24/1994	0		OTH	OTH	unk	unk		NA~ ()~~~In patient	895061001S	1						1	Arthralgia; Influenza; Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0074709	05/01/1995	NY	44.0	43		F	02/14/1995	pt recv vax over the subsequent 4 wk gradually devel some redness & tenderness @ inj site (persisted 2-3months) also devel severe arthralgias, & gen weakness & lethargy; tx w/Keflex for 14 days									Y	11/07/1994	11/08/1994	1	CBC, Sed rate, Chem profile, UA all nl; Biopsy-lymphocytic infiltrate	PVT	OTH	NONE	NONE		NA~ ()~~~In patient	895061002S	1						1	Arthralgia; Asthenia; Injection site hypersensitivity; Injection site pain; Somnolence	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0074710	05/01/1995	VA	43.0	43		F	02/16/1995	pt recv vax & w/in 18 hr began to exp severe arm pain (con to date reported); pt reports lt arm lateral tendonitis & a dec arm strength of 17 pounds in lt arm;									U	11/01/1994	11/29/1994	28		PUB	OTH	NONE	unk		NA~ ()~~~In patient	895061003S	1						1	Hypokinesia; Myasthenic syndrome; Pain; Tendon disorder	FLU3~PFIZER\WYETH~494810~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0074711	05/01/1995	IL				F	02/23/1995	pt recv vax OCT94; JAN 1995 pt began to complain of arthritis in the shoulder area;									N	10/01/1994	01/01/1995	92		PVT	OTH	unk	unk		NA~ ()~~~In patient	895066009A	1						1	Arthralgia; Arthritis	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0074712	05/01/1995	NJ	35.0	34		F	03/03/1995	pt recv vax & devel itching all over body; MD prescribed DPH, which mom said did not help the itching; just made the pt sleepy; also developed hair loss several wk p/vax which cont; MD has ordered blood work;				Y					N	11/01/1994				OTH	PVT	Tegretol, Mysoline, Phenobarbital	NONE		NA~ ()~~~In patient	895071001Q	1						1	Alopecia; Pruritus	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0074713	05/01/1995	NC	49.0	48		F	01/03/1995	pt recv vax & the following day devel pain on the lt side of the neck radiating to the shoulder & down the arm; pt was treated w/ASA, DPHq 4 hr & an IM inj of Toradol;				Y					Y	11/01/1994	11/02/1994	1		PUB	PVT	NONE	NONE	NONE	NA~ ()~~~In patient	895072001S	1						1	Neck pain; Pain	FLU3~PFIZER\WYETH~4948071~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0074714	05/01/1995	NC	47.0	47		F	01/03/1995	pt recv vax & the following day devel redness, swelling & warmth @ inj site; pt was treated w/ASA, DPH q 4 hr, & ice compresses @ the inj site;									Y	10/18/1994	10/19/1994	1		PUB	PVT	NONE	NONE		NA~ ()~~~In patient	895072005S	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948043~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0074715	05/01/1995	NC	39.0	39		F	01/03/1995	pt recv vax & the next day devel pain in the neck radiating to the shoulder; some swelling of the upper back lt shoulder was noted; pt was treated w/ASA & DPH q 4 hr as needed;									Y	11/01/1994	11/02/1994	1		PUB	PVT	NONE	NONE		NA~ ()~~~In patient	895072006S	1						1	Neck pain; Oedema; Pain	FLU3~PFIZER\WYETH~4948071~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0074716	05/01/1995	NC	45.0	45		F	01/03/1995	pt recv flu vax & the following day devel redness, swelling, & warmth @ the inj site; pt was treated w/DPH q 4 hr as needed & ice compresses 4 times daily to inj site;									Y	10/18/1994	10/19/1994	1		PVT	PVT	unk	NONE		NA~ ()~~~In patient	895073001S	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4948043~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0074717	05/01/1995	NJ	64.0	64		M	03/03/1995	pt recv vax & devel a rash over whole body which worsened & then resolved; pt visited MD @ the end of JAN, who prescribed a course of Pred;				Y					N	11/04/1994				PVT	PVT	Doxycycline	NONE	Obesity	NA~ ()~~~In patient	895073002S	1						1	Rash	FLU3~PFIZER\WYETH~4948078~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0074718	05/01/1995	WI	38.0	38		M	03/13/1995	pt recv vax & 1 or 2 days later, devel pruritus-treated w/an unspecified steroid; the itching abated, but on discontinuation of the steroid, the itching returned;pt was put on DPH which made pt dysfunctional; pruritus has worsened;				Y					N	10/25/1994	10/27/1994	2		OTH	OTH	NONE	NONE		NA~ ()~~~In patient	895090001S	1						1	Paraesthesia; Pruritus; Rash	FLU3~PFIZER\WYETH~4948038~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0074719	05/01/1995	IA	44.0	44		M	03/22/1995	bruise (1.5cm; has persisted 5 months), soreness, redness, & raised area @ inj site;									N	10/13/1994	10/13/1994	0		OTH	PVT	NONE	NONE	allergic to mold, ragweed, cats & fungus	NA~ ()~~~In patient	895094001S	1						1	Ecchymosis; Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~PFIZER\WYETH~4948044~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0074721	05/01/1995	PA	38.0	38		F	12/15/1994	mouth paresthesia (lips & tongue);									Y	11/17/1994	11/17/1994	0		PVT	PVT	NONE	NONE		NA~ ()~~~In patient	895097004S	1						1	Paraesthesia oral	FLU3~PFIZER\WYETH~4948115~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0074722	05/01/1995	PA	27.0	27		F	12/16/1994	pt exp SOB, cough tx epi;				Y					Y	11/07/1994	11/07/1994	0		PVT	OTH	unk	asthma	allergies: environmental, ASA, Percocet; asthmatic	NA~ ()~~~In patient	895100001S	1						1	Cough; Dyspnoea	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0072722	05/04/1995	WI	41.0	41		F	04/24/1995	arthralgias & nausea (pt has hx of porphyria);									Y	10/19/1994			pt did not report it till long after rxn	PVT	PVT			hx of porphyria	~ ()~~~In patient		1						2	Nausea; Vasodilatation; Arthralgia; Nausea	FLU3~PFIZER\WYETH~4948130~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4948130~3~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0059885	05/11/1995	CA	68.0	68		M	05/04/1995	started w/tingling in feet & hands progressing to lack of control of body, paralysis from nose down; on a resp for 10+ days; loss of memory; plasmapheresis (12 tx) plus 6 gamma globulin; In hospital a total of 16 wk;			Y	Y	Y	113	Y	Y	N	10/30/1993	11/05/1993	6	spinal tap to determine GBS	PUB	UNK	Lisinopril, Lasix & potassium	NONE	hypertension	~ ()~~~In patient		1						3	Amnesia; Coordination abnormal; Erectile dysfunction; Faecal incontinence; Guillain-Barre syndrome; Paraesthesia; Paralysis; Respiratory disorder	FLUX~PFIZER\WYETH~4938148~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0075687	05/12/1995	VA	25.0	25		M		pt recv vax;09nov94 flu vax adm, on 15dec94, pt donated blood; Red Cross informed pt that blood tested pos for HTLV-1;									U	11/09/1994	12/15/1994	36	Blood test pos for HTLV-1	OTH	OTH				~ ()~~~In patient	WAES95010339	1						1	HIV test positive	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0074222	05/23/1995	FL	48.0	48		F	04/05/1995	rash on face 2 hr p/shot next day progressed to swollen hands eyes; inc fatigue 19DEC94 went to MD t101, thyroid not working; inc sed rate 30; pain & burning @ inj site; + ANA r/o epstein barr/myofibrolitis			Y					Y	N	12/03/1994	12/03/1994	0		MIL	PUB		NONE	sulfa, sulfites, PCN, iodine fish oil dust, IBS;	NONE~ ()~~~In patient		1						1	Antinuclear antibody; Asthenia; Hypothyroidism; Injection site pain; Oedema peripheral; Pyrexia; Rash; Red blood cell sedimentation rate increased	FLU3~PFIZER\WYETH~4948116~4~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Disabling	Influenza
0074253	05/24/1995	CA	24.0	24		F	05/20/1995	heart rate 180+/min 2 wk; neurological, vertigo, dizziness;								Y	U	11/01/1976	11/01/1976	0	EEG, MRI	PUB	OTH	NONE	NONE	NONE	~ ()~~~In patient	CA95069	1						1	Dizziness; Tachycardia; Vertigo	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0074524	06/05/1995	CO	52.0	52		M	05/30/1995	pt devel generalized myalgias, fatigue, numbness of fingers to forearms 2wk p/vax; condition has persisted to present;									N	10/19/1994	11/01/1994	13	ANA, RF neg; ESR nl; CPK-288 on 12DEC94; CPK 123 on 15DEC94;	PUB	OTH	Atenolol; Lisinopril	NA	hypertension; allergies, PCN, ASA	~ ()~~~In patient		1						1	Asthenia; Blood creatine phosphokinase increased; Myalgia; Paraesthesia	FLU3~PFIZER\WYETH~4948145~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0074547	06/06/1995	PA	26.0	26		F	03/09/1995	1mo p/vax following problems occurred in arm where vaccinated: arm & shoulder pain; numbness of arm & hand; skin sunken in @ inj site; muscular weakness of arm & hand;								Y		10/06/1994	11/06/1994	31	bonescan; MRI; Nerve conduction study;	UNK	UNK	NONE			~ ()~~~In patient		1						1	Injection site atrophy; Myasthenic syndrome; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4948106~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0074548	06/06/1995	IL	3.0	3		F	06/02/1995	pt was given the flu vax on 4NOV94 on 15NOV started w/cough; 17NOV started w/fever; By 18NOV was in severe resp distress & was adm to hosp; dx viral pneumonia; cultures neg;					Y	7			Y	11/04/1994	11/15/1994	11	CXR/ECHO/Cultures neg;	PVT	PVT	NA	NA	preterm @ 26wks; BPD/grade IVM;	NA~ ()~~~In patient		1						1	Cough; Dyspnoea; Infection; Pneumonia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~01664P~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0074649	06/08/1995	SC	63.0	63		M	06/02/1995	pt recv vax; had tulosa-hunt synd; cluster HA & diplopia;diplopia resolved gradually over six wk period;MRi in dec was nl;all lab tests nl'									Y	11/01/1993	11/01/1993	0	nl seed rate, CBC, MRI	UNK	UNK				in pt, HA & diplopia w/ flu vax at 62y;~ ()~~~In patient		1						1	Diplopia; Headache	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0067672	06/09/1995	PA	66.0	66		F	10/25/1994	1 of 3 pts vaxed from the same lot# who exp an inj site rxn;pt recvd vax & devel beefy red 8x8 cm discoloration @ inj site & itching p/initial tenderness;MD visit-recovered;				Y					Y	10/11/1994	10/13/1994	2	unk	PVT	PVT	Lanoxin, Tamoxifen, Synthroid, Calcium, Vitamin E	healthy	hypothyroidism, supraventricular tachycardia, breast cancer;	unk if pt had adverse event following prior vax~ ()~~~In patient	940220901	1						2	Injection site hypersensitivity; Injection site pain; Pruritus	FLU3~PARKE-DAVIS~00974P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~2|TD~LEDERLE LABORATORIES~364934~UNK~IM~GM~TD ADSORBED (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0067678	06/09/1995	PA	56.0	56		F	10/25/1994	1 of 3 pts vaxed from the same lot# who exp an inj site rxn;pt recvd vax 17OCT94 & 20OCT devel a large, red area-warm to touch (8cm diameter) @ Td inj site;pt recovered;									Y	10/17/1994	10/20/1994	3	NA	PVT	PVT	Biotin, Selenium, Lanoxin<lasix, Buspar,Synthroid,Ascriptin, Seldane,Multivitamins,Coumadin,K-DUR, Zarovolum	healthy	heart condition;	NA~ ()~~~In patient	940220903	1						2	Injection site hypersensitivity; Vasodilatation	FLU3~PARKE-DAVIS~00974P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2|TD~LEDERLE LABORATORIES~364934~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~2	USA		Influenza
0074833	06/13/1995	PA	39.0	38		F	06/07/1995	pt recv vax & arm was instantly sore as if someone beat it w/a hammer; few wk passed & soreness persisted, causing the pt to wake up in the noc w/discomfort; also pt could not lift arm above head w/o sharp pain; consulted MD 13JAN95;				Y					U	10/18/1994	10/18/1994	0	unk	PVT	PVT	NONE	NONE	sulfa drug allergy	~ ()~~~In patient		1						1	Hypokinesia; Insomnia; Myalgia; Pain	FLU3~PARKE-DAVIS~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0074852	06/13/1995	NE	6.0	6		F	06/05/1995	sz, sl fever 15-16 hr p/flu shot; had hx of other sz problems;				Y					Y	11/02/1994	11/03/1994	1	NONE	PVT	PVT	Depakote	NONE	VSD, repaired/duodenalatresia repaired, sz, febrile	~ ()~~~In patient		1						1	Condition aggravated; Convulsion; Febrile convulsion; Pyrexia; Condition aggravated; Convulsion; Pyrexia	FLU3~CONNAUGHT LABORATORIES~2F31143~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0074852	06/14/1995	NE	6.0	6		F	05/12/1995	pt recv vax 2NOV94 & became febrile then devel sz 0500 3NOV94; pt had prev sz disorder;				Y					Y	11/02/1994	11/03/1994	1		PVT	OTH	Depakote		sz DO	~ ()~~~In patient		1						2	Condition aggravated; Convulsion; Febrile convulsion; Pyrexia; Condition aggravated; Convulsion; Pyrexia	FLU3~CONNAUGHT LABORATORIES~2F31143~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0074894	06/14/1995	TX				F	06/06/1995	pt recv vax 17OCT94 & w/in 24 hr devel a viral synd w/fever, achiness & severe chills; began to exp visual problems & was dx w/bilat ischemic optic neuropathy; vision was substantially dec to 20/400 in rt eye & 20/40 in lt eye;				Y				Y	N	10/17/1994	10/18/1994	1	visual acuity folowing optic neuropathy is 20/400 in rt eye & 20/40 in lt eye;	PVT	PVT	unk	unk	NONE	NA~ ()~~~In patient	895157007A	1						1	Chills; Infection; Myalgia; Optic neuritis; Pyrexia; Visual disturbance	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0074895	06/14/1995	CA	70.0			F	05/24/1995	pt recv flu vax in 1994; 3 days later pt devel bilateral lower extremity weakness & paresthesias; pt was hospitalized & MD dx transverse myelitis affecting the lower limbs; pt has improved but cont to have bilat weakness					Y				U					OTH	OTH	unk	NONE		NA~ ()~~~In patient	895150002A	1						1	Myasthenic syndrome; Myelitis; Paraesthesia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0074909	06/14/1995	MA	46.0			M		mild paralysis lt shoulder; pt recv flu vax & was unable to to exercise routine				Y					U				CBC, PE later ATB prescribed	PUB	UNK		flu		~ ()~~~In patient		1						1	Paralysis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0068775	06/16/1995	WY	44.0	44		F	11/10/1994	2PM eyes red, mattered, burning, scratchy; chills/fever q 2 hr; nausea/vomiting/h/a, lethargy 12 hr;									Y	11/08/1994	11/08/1994	0	eye exam;	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	WY9429	1						2	Chills; Conjunctivitis; Eye pain; Headache; Nausea; Pyrexia; Somnolence; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51072~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0071891	06/16/1995	TX	83.0			M		GBS; B12nl; ESR nl PSA nl; RPR NR:					Y			Y		10/12/1994	11/10/1994	29	CT head WNL; 14NOV94 CSF no WBC's; Glucose 88; protein 60; CSF 17NOV94: glucose 62; protein 128; 8WBC-100% lymphs	UNK	UNK	Nifedipine; Timolol; ASA		Glaucoma; HTN; NKA;	~ ()~~~In patient		1						2	Faecal incontinence; Guillain-Barre syndrome; Hypokinesia; Hyporeflexia; Myasthenic syndrome; Urinary incontinence; CSF test abnormal; Faecal incontinence; Guillain-Barre syndrome; Hypokinesia; Myasthenic syndrome; Urinary incontinence	FLU3~PARKE-DAVIS~00184P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00184P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Hospitalisation,Disabling	Influenza
0074987	06/16/1995	WY	76.0	75		F	10/27/1994	27OCT94 c/o inc reddened area w/ sl swelling rt triceps area; redness is 4x 5 pt states getting larger; some aching in shoulder deltoid area & extending to neck areas; pt advised s/sx of infection, use of heat or cold packs & antiinflamma									Y	10/20/1994	10/24/1994	4		PUB	PUB		NONE	denies	~ ()~~~In patient	WY9421	1						1	Hypoaesthesia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia; Neck pain	FLU3~CONNAUGHT LABORATORIES~4F51024~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~4F61058~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0074990	06/16/1995	WY	47.0	47		F	11/10/1994	throat swollen couldn't swallow; eyes real real red & hurt; felt had something in throat around noon; 430 felt real weak from waist down-would fall if tried to walk; chills-shaking so cold couldn't warm up;									Y	11/09/1994	11/09/1994	0		UNK	UNK	Diabeta Synthroid, NPH insulin	NONE	DM-allergy to PCN, Phenergan, ASA, keflex	~ ()~~~In patient	WY9425	1						1	Asthenia; Chills; Conjunctivitis; Dysphagia; Eye pain; Laryngospasm; Tremor	FLU3~CONNAUGHT LABORATORIES~4F51072~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0074991	06/16/1995	WY	32.0	32		F	11/10/1994	330 about 7PM started coughing-hard to breath tickle in throat-wheezing really bad-burned in chest felt heavy;propped up to breath-didn't get worse so slept; next day better eyes puffy-felt exhausted felt better 1 1/2 hr;									Y	11/07/1994	11/07/1994	0	1	OTH	UNK	NONE	NONE	NONE	~ ()~~~In patient	WY9426	1						1	Asthenia; Asthma; Chest pain; Cough; Dyspnoea; Face oedema	FLU3~CONNAUGHT LABORATORIES~4F51024~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0074992	06/16/1995	WY	47.0	47		F	11/10/1994	pt recv vax 8-9AM; went to school nurse approx 1230 w/tight feeling in throat-flushed face red eyes- heavy feeling in chest; hoarse; was taken to clinic given Epi; rapid improvement could take a deep breath again; no difficulties today;									Y	11/08/1994	11/08/1994	0		PUB	UNK	Dyazide	NONE	Meniere's -occcas Eczema	~ ()~~~In patient	WY9427	1						1	Chest pain; Conjunctivitis; Dysphonia; Laryngospasm; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51024~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0074993	06/16/1995	WY	37.0	37		M	11/10/1994	330PM-430PM vax around 630PM onset something caught in throat coughing-hacking intense pressure in lungs & face;pain in eyes like h/a;chills-fever-took hot tang-sound like terrible cold still raspy throat;severe shaking short 1/2hr achy									Y	11/07/1994	11/07/1994	0		UNK	UNK	NONE	NONE	NONE	~ ()~~~In patient	WY9428	1						1	Chest pain; Cough; Eye pain; Headache; Myalgia; Pharyngitis; Pyrexia; Tremor	FLU3~CONNAUGHT LABORATORIES~4F51024~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0074995	06/16/1995	WY	31.0	31		F	11/10/1994	by noon achy-not feeling well throat closing up, coughing, above breast ached like filling up w/fluid; pt took allergy pills; that eve severe chills so cold feet were ice, teeth chattering; 10NOV sweaty, clammy, t101; 9NOV eyes burned;				Y					Y	11/08/1994	11/08/1994	0	dx pneumonia	UNK	UNK	Vitamins; APAP allergy as needed	NONE	dust mites; corn tassles; horses; oat	~ ()~~~In patient	WY9430	1						1	Chest pain; Chills; Cough; Eye pain; Laryngospasm; Myalgia; Pneumonia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51024~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0074996	06/16/1995	WY	38.0	38		F	11/14/1994	TD administered 9NOV94 TC recv 11NOV94 430PM fr school nurse states pt c/o numbness & pain lt cheek, neck, arm, rib area & buttocks; encouraged to seek med attention;									Y	11/09/1994	11/09/1994	0		PUB	PUB	NONE	NONE	sulfa allergy	~ ()~~~In patient	WY9431	1						1	Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51072~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~4F61058~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0074997	06/16/1995	WY	31.0	31		F	11/14/1994	10 mins p/flu vax c/o dizziness, shaking, confusion, weakness, progressing to inc pulse, inability to stand or walk; Epi given; In ER DPH & Cortisone were administered;				Y					Y	11/12/1994	11/12/1994	0		OTH	PUB	NONE	NONE	hx of multiple allergies, esp to preservatives; x/did not say that when screened;	~ ()~~~In patient	WY9432	1						1	Asthenia; Confusional state; Dizziness; Hypokinesia; Tachycardia; Tremor	FLU3~CONNAUGHT LABORATORIES~4F51072~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0074998	06/16/1995	WY	27.0	27		F	11/18/1994	vax given @ noon 16NOV @ 545PM same day had sudden onset of fever, muscle aches, jerky muscles, was not able to see;taken to ER t102.6;APAP given;BC & ABG's done; temp down; pt also states passed out for a few mins & throat got tight				Y					Y	11/16/1994	11/16/1994	0	BC, ABG's done & nl	OTH	PVT	NONE	NONE	CP	~ ()~~~In patient	WY9433	1						1	Laryngospasm; Muscle twitching; Myalgia; Pyrexia; Syncope; Visual disturbance	FLU3~CONNAUGHT LABORATORIES~4F51102~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0074999	06/16/1995	WY	42.0	42		F	11/21/1994	pt recv vax 28OCT94 5PM started having sx 29OCT 12noon fever, chills, vomiting, couldn't hardly breath-4PM went to ER 7PM 30OCT saw MD said viral flu w/bronchial spasms, given Albuterol tx in ER;				Y					Y	10/28/1994	10/29/1994	1	NONE	PUB	PUB	birth control	NONE	Morphine-did not eat eggs or use thimersol that date	~ ()~~~In patient		1						1	Asthma; Chills; Dyspnoea; Infection; Influenza; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51165~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0075000	06/16/1995	WY	47.0	47		F	11/28/1994	rt arm, no external marks; certain movements across chest cause pain; taking clothes off;Motrin bid helps or awakens @ noc									Y	11/07/1994	11/07/1994	0	NONE	PUB	UNK	Vantac	NONE	NKA	NONE~ ()~~~In patient	WY9435	1						1	Pain	FLU3~CONNAUGHT LABORATORIES~4F51024~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~4F61058~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0074986	06/18/1995	WY	61.0	61		F	10/27/1994	pt recv vax 19OCT94, no side effects other than mild tenderness until 24OCT94; 24OCT94 in the evening lt deltoid area of shot started itching, when looked @ site was red & swollen;									U	10/19/1994	10/24/1994	5	NONE	PUB	OTH	NONE	stated none	stated none when asked	NA~ ()~~~In patient	WY9420	1						1	Injection site hypersensitivity; Injection site oedema; Pain; Pruritus	FLU3~CONNAUGHT LABORATORIES~4F51165~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~4A61008~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0075248	06/19/1995	FL	79.0	79		F	06/08/1995	Diffuse myalgias & arthralgias beginning within few days after influenza vax; has features of an atypical rheumatoid arthritis;									N	11/02/1994			ESR 85, ANA 1:40, RF 53.2;	PVT	PVT	Diabeta;		none	~ ()~~~In patient		1						1	Arthralgia; Laboratory test abnormal; Myalgia; Red blood cell sedimentation rate increased; Rheumatoid arthritis; Myalgia	FLU3~CONNAUGHT LABORATORIES~4F51015~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~4F51015~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0075263	06/21/1995	WY	40.0	40		F	01/13/1995	pt recv vax & inj stung; next day very sore; pain has cont until now; pain does not wake @ noc; pt states WSS of 50% of strength in lt arm w/lump but tenderness rt @ inj site; tx by pt excedrin extra strength;				Y						10/19/1994	10/20/1994	1		PUB	UNK		NONE	NONE	~ ()~~~In patient	WY9512	1						1	Injection site mass; Injection site pain; Myalgia; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~4F51024~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~4F61058~2~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0069526	06/26/1995	MI	49.0	49		F	11/29/1994	starting on 22OCT94 pt c/o chills, h/a, backache, cough ; recurrent 11nov & 18nov;									Y	10/19/1994	10/22/1994	3		PUB	PUB			not known	~ ()~~~In patient	MI95051	1						2	Back pain; Chills; Cough; Headache	FLU3~CONNAUGHT LABORATORIES~4F51165~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0075430	06/26/1995	FL	50.0	50		F	06/21/1995	pt recv vax; red pimple 1 wk p/ vax w/ pain; irregular raised, erythematous tender lesion; hemangioma; dx of pyogenic granuloma;									Y	11/16/1994	11/23/1994	7	skin biopsy	PVT	PVT			hypertension, hypercholestrolemia	~ ()~~~In patient		1						1	Acne; Granuloma; Pain; Rash; Skin ulcer; Vascular anomaly	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0075559	07/03/1995	AK	70.0	69		F	05/19/1994	pt expired approx 2 1/2wks p/vax; pt died of MI; had chest pain approx 1 wk prior to MI; coded & expired;	Y	11/13/1994								10/26/1994				PUB	PUB				~ ()~~~In patient	AK95021	1						1	Chest pain; Myocardial infarction	FLU3~CONNAUGHT LABORATORIES~4F51023~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0075560	07/03/1995	AK	65.0	65		M		pt expired approx 1 wk p/vax given; clinic reports pt's death was expected; pt was in end-stage liver disease, COPD, on 02	Y	11/23/1994								11/16/1994				PUB	PUB			end-stage liver disease, COPD, on 02	~ ()~~~In patient	AK95022	1						1	Unevaluable event	FLU3~CONNAUGHT LABORATORIES~4F51023~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0075787	07/10/1995	WA	37.0	37		F	11/04/1994	pt recv vax;bad asthma attack;achy all over;had numbness in rt leg;never had adverse rxn w/ previous flu shots;to call MD in pm & advised hlth dept of result;									U	11/04/1994	11/04/1994	0		PUB	UNK			asthma in past but not this severe; hx of m.s.	~ ()~~~In patient	WA951106	1						1	Asthma; Condition aggravated; Myalgia; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51025~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0075788	07/10/1995	WA	54.0	54		M	12/01/1994	4 hr p/flu shot, presented @ MD w/profound rigor, vasoconstriction, & barely able to get around; acutely ill & conjunctivitis; direct admit fr ofc to hosp; admitted for rigor, t102 unk origin; blood culture drawn, UA cult of eye;				Y	Y				Y	11/15/1994	11/15/1994	0	admit & discharge & lab copies available; blood culture, U/A;	OTH	PVT	NONE	conjunctivitis-pt unaware	NONE	~ ()~~~In patient	WA951107	1						1	Chills; Conjunctivitis; Haematuria; Hypokinesia; Malaise; Pyrexia; Red blood cell sedimentation rate decreased; Vasospasm	FLU3~CONNAUGHT LABORATORIES~4F51025~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0075854	07/11/1995	CA	27.0	27		M	06/28/1995	pt recv vax;had fever of 102; HA, body aches, chills & induration & erythema at inject site;white blood cell count 31,000; required 2 visits to er;				Y					Y	05/27/1995	05/28/1995	1	white blood cell count 31,6000: 84 segs, 4 band	MIL	MIL	na	none	hx of splenectomy	na~ ()~~0.00~Patient		1						1	Chills; Headache; Injection site hypersensitivity; Injection site mass; Leukocytosis; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~M285LB~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~CONNAUGHT LABORATORIES~4C61110~2~~~MENINGOCOCCAL (MENOMUNE)~1|PPV~MERCK & CO. INC.~0118AOAF~2~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0069690	07/14/1995	IL	72.0	72		M		pt recvd vax 5OCT94 & w/in hrs pt exp severe swelling & pain in arm which was about twice its nl size, & redness, warmth, pain & soreness @ inj site;				Y					Y	10/05/1994	10/05/1994	0	No relevant data;	PVT	PVT	Mevacor, Norvasc, Baby ASA, Ismo, Lasix, Dalmane, Nitro-spray,Xanax	rash, groin	allergy, iodine; coronary artery disease;high blood pressure;hypercholesterolemia;heart failure, chronic;angina	~ ()~~~In patient	WAES94100424	1						2	Injection site hypersensitivity; Injection site pain; Myalgia; Oedema peripheral; Pain; Vasodilatation	FLU3~PARKE-DAVIS~01564P~6~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~MERCK & CO. INC.~0536A~1~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0080563	07/14/1995	AZ	35.0			M		pt recvd vax & exp redness, swelling & pain @ inj site;pt also sick;pt devel a local rxn @ the site of the flu vax as well;17OCT94 pt exp had not subsided & pt was planning on visiting MD;									N				No relevant data;	OTH	OTH				~ ()~~~In patient	WAES94100554	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Injection site reaction; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0080565	07/14/1995	CA	39.0			M		pt recvd vax & on 17NOV94 pt exp 2 szs;f/u from the MD indicated that pt had 2 episodes of passing out, but an EEG was neg for sz activity;pt recovered;									Y		11/17/1994		EEG nl;	PUB	OTH			allergy, horse serum	~ ()~~~In patient	WAES94100612	1						1	Convulsion; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0080600	07/14/1995	MN	41.0	41		F		pt recvd vax;that noc, devel high fever & lt arm & underarm from elbow up as well as chest were swollen & red;site of inject no longer discernible;had pain throughout the entire area;sxs worsened by am;f/u:md has no further contact w/ pt									U	10/17/1994	10/17/1994	0	no relevant data	PUB	PUB	none		bronchitis chronic;	~ ()~~~In patient	WAES94100618	1						1	Oedema peripheral; Pain; Pyrexia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1474W~1~SC~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0080612	07/14/1995	ND	10.0			F		pt recvd vax; 10 hrs later, exp 6x6cm local erythema, induration, swelling & tenderness; fever; md expressed a concern for particular lot;									U	10/26/1994			no relevant data	OTH	OTH	multivits, depakene, apap		palsy, cerebral; mental retardation; sz dis	~ ()~~~In patient	WAES94101026	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0536A~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0080618	07/14/1995	TN	71.0			F		pt recvd vax; exp soreness, weakness & redness at inject site & swelling & numbness in arm where vax given;also exp sl fever									Y	10/31/1994			no relevant data	PVT	PVT	synthroid		hypertension; diabetes non-insulin dependent;	~ ()~~~In patient	WAES94110330	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Myasthenic syndrome; Oedema peripheral; Paraesthesia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0433A~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0080625	07/14/1995	SC	60.0	60		M		pt recvd vax; sever soreness, pain , swelling, redness, warmth in arm; flu like sxs & myalgia; sxs resolved w/in 6 days									Y	11/21/1994	11/21/1994	0	no relevant data	PVT	PVT				~ ()~~~In patient	WAES94110961	1						1	Influenza; Myalgia; Oedema peripheral; Pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~2~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0080632	07/14/1995	IA	38.0	38		F		pt recvd vax;following day devel swollen red arm from the shoulder to elbow in injected arm;feverish,very tired & dragging & poor appetite;7nov94 felt better but rt arm still swollen from shoulder to elbow;had lump at inject site									Y	11/04/1994	11/05/1994	1	no relevant data	PUB	PVT	apap			~ ()~~~In patient	WAES94120589	1						1	Anorexia; Asthenia; Injection site mass; Oedema peripheral; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4948073~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0433A~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0076061	07/24/1995	PR	60.0			F	07/20/1995	pt recv vax;devel GBS;was paralyzed for 3 wk;f/u:devel sx & was hosp,intubated via tracheostomy;sx all resolved;					Y				U	08/26/1994				PVT	UNK				~ ()~~~In patient	CO6019	1						1	Guillain-Barre syndrome; Paralysis; Apnoea; Dyspnoea; Guillain-Barre syndrome; Paralysis; Guillain-Barre syndrome; Paralysis	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Hospitalisation	Influenza
0076113	07/24/1995	CA	55.0	55		M	07/10/1995	pt recv vax; GBS; tx w/ plasmapheresis										11/09/1994	12/03/1994	24		UNK	UNK				~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0076154	07/25/1995	CA	55.0	55		F	06/19/1995	28OCT94 pt recv vax; 10NOV began feeling tired & fatigued; DEC94 weakness, diarrhea, nausea, loss of appetite; JAN95 body breakdown-extremely weak (diff walking) floppy feet & hands partially paralyzed as if circulation gone; ashen color;				Y						10/28/1994	11/10/1994	13		OTH	UNK	Mestinon & Premarin	Myasthenia gravis since 1963	neurological problem not related to MG	NONE~ ()~~~In patient		1						1	Anorexia; Asthenia; Chest pain; Hypokinesia; Hypotonia; Pallor; Paralysis; Speech disorder	FLU3~CONNAUGHT LABORATORIES~4F51025~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0076155	07/25/1995	VA	78.0	78		F	02/13/1995	pt recv vax 9FEB95 & called in 10FEB95 to report arm had 2 lump & was sore but not itchy; called back 13FEB to report 3 reddened sore arm w/pruritis										02/09/1995	02/09/1995	0		UNK	UNK				~ ()~~~In patient		1						1	Pain; Pruritus; Skin nodule; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51010~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0076223	07/31/1995	NE	60.0	60		F	07/26/1995	pt recv vax & had one episode of flu-like FEB95; was sick for about 3 wk & @ that time had a non-specific gastritis & over a period of time forward lost 20 lb; devel back pain in April; c/o some musculoskeletal explanations & saw MD;					Y	21			U	10/28/1994	04/15/1995	169	dx devics synd	OTH	OTH	NONE	NONE	no history until FEB95	NONE~ ()~~~In patient		1						1	Back pain; Bone disorder; Gastritis; Multiple sclerosis; Myelitis; Neuropathy; Paraesthesia; Weight decreased	FLU3~PFIZER\WYETH~4948147~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0076264	07/31/1995	GA	58.0	58		M	07/24/1995	pt devel disorder diagnosed as polymyalgia rheumatica characterized by pain in hip, shoulder, upper arm & upper leg area;				Y					N	10/27/1994	03/13/1995	137	high erythrocyte sed rate 122; highc reactive protein 65; sl anemia;	PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Anaemia; Arthralgia; Laboratory test abnormal; Myalgia; Pain; Red blood cell sedimentation rate increased; Rheumatoid arthritis; Tendon disorder	FLU3~CONNAUGHT LABORATORIES~4F51006~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0076351	08/02/1995	NE	58.0			M		pt recv vax; dizziness & v; possible rxn to vax;					Y					10/27/1993	11/01/1993	5	HTN, hypercholesterodermia	UNK	UNK	Quinapril			~ ()~~~In patient		1						1	Dizziness; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0076352	08/02/1995	NE	59.0			M	09/28/1994	pt recv vax; same day, pt's theophylline level was 16.1; adm to hosp because theophylline level was 25.6; had n & v beginning on the day prior to adm to hosp;EEG suggested sinus tachycardia;					Y					10/05/1993	10/08/1993	3	EEG suggested sinus tachycardia;	UNK	UNK	Theodur			~ ()~~~In patient		1						1	Drug level increased; Nausea; Tachycardia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0076061	08/04/1995	PR	68.0			F	07/07/1995	p/receiving fluzone inject, pt suffered a GBS rxn, requiring pt to be intubated & a tracheostomy performed; pt was paralyzed for 3 wk; pt has recovered			Y	Y	Y		Y		Y	08/26/1994				PVT	OTH				~ ()~~~In patient		1						2	Guillain-Barre syndrome; Paralysis; Apnoea; Dyspnoea; Guillain-Barre syndrome; Paralysis; Guillain-Barre syndrome; Paralysis	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Life Threatening,Hospitalisation	Influenza
0076391	08/07/1995	FL	54.0	54		F	02/08/1995	lt arm paralysis; face paralysis; legs, hands numb; dx GBS;			Y	Y	Y	18			Y	09/30/1994	10/11/1994	11	Cat scan-MRI + spinal tap	OTH	PVT	unk	last stages of cold	unk	~ ()~~~In patient		1						1	Asthenia; Facial palsy; Guillain-Barre syndrome; Paraesthesia; Paralysis; Anorexia; Asthenia; Back pain; Dysphagia; Hypokinesia; Injection site pain; Insomnia; Paralysis	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~MEDEVA PHARMA, LTD.~E2504GC~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Life Threatening,Hospitalisation	Influenza
0075248	08/10/1995		79.0	79		F		pt c/o muscle aches on & off x 3 months; thinks it started p/getting flu shot; dx post vax myalgias; tx Pred x 3 days then taper x 9 days;										11/02/1994	01/17/1995	76		UNK	UNK				~ ()~~~In patient		1						2	Arthralgia; Laboratory test abnormal; Myalgia; Red blood cell sedimentation rate increased; Rheumatoid arthritis; Myalgia	FLU3~CONNAUGHT LABORATORIES~4F51015~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~4F51015~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0081163	08/18/1995	FL				F	04/10/1995	aching & muscle tightness where shot given (inj site pain);									Y	09/27/1994	09/28/1994	1		OTH	OTH	unk	unk		~ ()~~~In patient	895117002S	1						1	Injection site pain; Myalgia	FLUX~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0081164	08/18/1995	FL	68.0			M	04/10/1995	aching where shot given (inj site pain) & muscles tightness									Y	09/27/1994	09/28/1994	1		OTH	OTH	unk	unk		~ ()~~~In patient	895117003S	1						1	Hypertonia; Injection site pain	FLUX~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0081165	08/18/1995	CA				M	05/11/1995	burning during vax (inj site pain) & very inflamed 1/2 hr p/vax;flu vax erroneously administered instead of PPD									U	05/11/1995	05/11/1995	0		PVT	OTH	unk	unk		~ ()~~~In patient	895138001S	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0076678	08/21/1995	MO	71.0	70		M	08/18/1995	onset paresthesia, 7 days p/vax;pt became weak, uncoordinated & exp diff swallowing;14OCT adm to hosp-CSF studies confirmed acute inflammatory demyelinating peripheral neuropathy;dx GBS- resp failure, hyponatremia, hypokalemia, paralysis			Y	Y	Y	39			N	09/29/1994	10/06/1994	7	gram pos coccci consistent w/enterococcus; bacterial conjunctivitis & cultures showed a heavy isolation of gram pos cocci & heavy isolation of gram pos bacillus	PVT	OTH		NONE	NKDA, prostate cancer	~ ()~~~In patient	CO6062	1						1	Apnoea; Guillain-Barre syndrome; Hypokalaemia; Hyponatraemia; Inappropriate antidiuretic hormone secretion; Infection; Myocardial infarction; Paralysis; Apnoea; Guillain-Barre syndrome; Hypokalaemia; Hyponatraemia; Inappropriate antidiuretic hormone secretion; Infection; Myocardial infarction; Paralysis	FLU3~CONNAUGHT LABORATORIES~4F51164~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1|FLU3~CONNAUGHT LABORATORIES~4F51164~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~358959~UNK~~~PNEUMO (PNEUMOVAX)~2	USA	Life Threatening,Hospitalisation	Influenza
0076678	08/23/1995	MO	71.0	70		M	03/13/1995	pt recv vax;7 days later,paresthesia;exp GBS;respiratory failure;non-Q wave M.I.;Hyponatremia;hypokalemia;SIADH;paralysis;to intensive care;significant cardiac disease;labs test pos for gram cocci consistent w/ enterococcus;stable temp;			Y	Y	Y	39		Y	N	09/29/1994	10/06/1994	7	acute inflamatory demyelinating peripheral neuropathy & clinical evidence to support GBS;	PVT	OTH	depo-lenpson	none	nkda, prostate CA	unk~ ()~~~In patient		1						2	Apnoea; Guillain-Barre syndrome; Hypokalaemia; Hyponatraemia; Inappropriate antidiuretic hormone secretion; Infection; Myocardial infarction; Paralysis; Apnoea; Guillain-Barre syndrome; Hypokalaemia; Hyponatraemia; Inappropriate antidiuretic hormone secretion; Infection; Myocardial infarction; Paralysis	FLU3~CONNAUGHT LABORATORIES~4F51164~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1|FLU3~CONNAUGHT LABORATORIES~4F51164~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~358959~UNK~~~PNEUMO (PNEUMOVAX)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0069276	09/06/1995	PA	73.0			F	12/20/1994	pt recvd vax 4OCT94 & 2 days later lt arm was swollen;pt also had a fever;6OCT MD visit-dx:cellulitis lt arm (upper arm to mid-forearm), suspected to be pnu-immune site;rx Dicloxicillin/warm soaks;recovered;				Y					Y	10/04/1994	10/06/1994	2	NA	PVT	OTH	NA			NA~ ()~~~In patient	940257201	1						2	Cellulitis; Oedema peripheral; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~~UNK~~~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0081245	09/06/1995	AZ				U	10/04/1994	pt recvd vax; swelling & redness from elbow to shoulder occurring w/in hrs;seen in ofc; instructed to tx w/ ice & dph;									U				none	PVT	PVT	unk	unk	unk	unk~ ()~~~In patient	940205501	1						1	Oedema peripheral; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0081249	09/06/1995	PA	79.0	79		F	10/12/1994	pt recvd vax;later in eve, had small, raised, red area surrounding pnu immune site;very edematous, hot to the touch & red; no fever; tx w/ analgesics;				Y					Y	10/11/1994	10/11/1994	0	none	PVT	PVT	zantac	respectively healthy for age	hernia, arthritis, dementia;had bowel obstruction & esophagitis	none~ ()~~~In patient	940212201	1						1	Injection site hypersensitivity; Oedema peripheral; Vasodilatation	FLU3~PARKE-DAVIS~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~384961~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0081259	09/06/1995	TX	35.0	35		M	10/06/1994	pt recvd vax; fever of 104; inject site react & axillary lymph node enlargement;rx steroids,atbs,dph,apap				Y					N	10/04/1994	10/05/1994	1	none	PVT	PVT	seldane, motrin	healthy		none~ ()~~~In patient	940214601	1						1	Injection site reaction; Lymphadenopathy; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F5113~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~380956~1~SC~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0081260	09/06/1995	TX	10.0	10		F	10/06/1994	pt recvd vax;had fever of 104, inject site react & axillary lymph node enlargement; to md; tx atb, steroid,dph & apap				Y					N	10/04/1994	10/05/1994	1	none	PVT	PVT	none	healthy		none~ ()~~~In patient	940214602	1						1	Injection site reaction; Lymphadenopathy; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F5113~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~380956~1~SC~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0081300	09/06/1995	UT	37.0	37		M	11/15/1994	pt recvd vax; w/in several hrs exp fever, chills & pnu immune became swollen, red & warm to touch; dx cellulitis; to hosp w/ questionable pneumonia rt middle lobe infiltrate; no cough; tx w/ atb;					Y	5			Y	11/11/1994	11/11/1994	0	cultures done all neg; blood work WBC 9900; endocarditis workup nl;	PVT	PVT	tambocor, lanoxin, coumadin, relafin	heart condition	aortic valve replacement; arrhythmias;	none~ ()~~~In patient	940239801	1						1	Cellulitis; Drug ineffective; Infection; Injection site hypersensitivity; Injection site oedema; Pneumonia; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4FS1129~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~380957~1~IM A~~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0081316	09/06/1995	OK	70.0	70		F	10/19/1994	pt recvd vax; devel pain, swelling & redness at inject site; dx cellulitis; no cultures taken;				Y					N	10/17/1994	10/17/1994	0	no cultures taken	PVT	PVT	mevacor, cardizem, zoloft	none	allergies asthma	none~ ()~~~In patient	940219601	1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~380957~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0081317	09/06/1995	OK	71.0	71		F	10/19/1994	pt recvd vax; devel pain, swelling & redness at inject site; dx w/ cellulitis; fever & entire arm was swollen;				Y					N	10/12/1994	10/12/1994	0	no cultures taken	PVT	PVT	none	healthy	no allergies	none~ ()~~~In patient	940219602	1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Pyrexia	FLUX~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~380957~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0081318	09/06/1995	OH	69.0	68		F	10/25/1994	pt recvd vax;rt arm hurting at ppv site;felt exhausted few days later; gen weakness, tired & sleepy, resp problems; coughing, tightness in chest, SOB;dx pneumonia;				Y					N	10/03/1994	10/04/1994	1	blood work, EKG & mamogram done 3oct94 all nl;dx pneumonia per pulmonary testing	PVT	PVT		healthy	arthritis	unk~ ()~~~In patient	940220401	1						1	Asthenia; Chest pain; Cough; Drug ineffective; Dyspnoea; Infection; Injection site pain; Pneumonia	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0081319	09/06/1995	SC	37.0	37		F	10/18/1994	pt recvd vax; exp swelling of entire arm where vax was adm;									Y	10/17/1994	10/17/1994	0	unk	PVT	PVT	none	none	none	none~ ()~~~In patient	940220801	1						1	Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~4948111~3~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~362968~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0081366	09/06/1995	CA				U	10/28/1994	16 out of 29 pts recvd vax in opposite arm 19OCT94 & all exp inj site rxn @ pnu-immune site (erythema, tenderness, swelling, adenitis)-size from quarter to shoulder/elbow;MD visit rx:ice pack/Motrin;pt recovered;				Y					Y	10/19/1994	10/19/1994	0	NA	PVT	PVT	NA	healthy		NA~ ()~~~In patient	940225601	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Lymphadenopathy	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~376967~1~IM A~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0081367	09/06/1995	MI	77.0	77		F	10/26/1994	pt recvd vax 17OCT94 & later in evening began exp weakness & severe pain in upper body muscles;(chest, back, neck);MD visit 25OCT;APAP given;CBC results pending;dx myositis & post viral synd				Y					Y	10/17/1994	10/17/1994	0	CBC results pending;DX myosytis & post viral synd	PVT	PVT	NONE	healthy	pt was hospitalized for pneumonia 6OCT94;discharged wk of 10OCT94 p/recovering from pneumonia (type unk);finished biaxin treatment 13OCT;CXR done 17OCT94 prior to vax nl;	NONE~ ()~~~In patient	940225701	1						1	Back pain; Chest pain; Myasthenic syndrome; Myositis; Neck pain	FLU3~PARKE-DAVIS~00374P~2~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~390965~1~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0081373	09/06/1995	FL	45.0	45		M	11/10/1994	pt recvd vax & approx 2 wks later had routine office visit & reported to MD that for 2 days following vax had fever of 100.5, erythema-6 long & soreness @ pnu-immune inj site;rx APAP;recovered;									Y	10/14/1994	10/14/1994	0	NONE	PVT	PVT	Bactrim DS/Ansamycin/G-CSF	healthy	allergies: Sudafed (rash);ACtifed (rash);no birth defects;medical conditions AIDS (CDC stage A3; chronic HBV infect	NONE~ ()~~~In patient	940234701	1						1	Injection site hypersensitivity; Injection site pain; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E2614KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~360961~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0081386	09/06/1995	FL	73.0	73		F	01/06/1995	1 of 5 pts (out of 40 pts) vaxed from the same lot who devel a local rxn consisting of rash surrounding site;rash appeared w/in 3 days of vax (varying in size in all 5 pts; largest from shoulder to elbow);area sore & tender;no fever;				Y					Y	12/07/1994	12/07/1994	0	NONE	PVT	PVT	Zantac/Vasotec/Zocor	HTN;palpatations	spinal stenosis;prostate cancer;allergic to tetracycline;last flu vax OCT93	NONE~ ()~~~In patient	950006402	1						1	Injection site hypersensitivity; Injection site pain	FLUX~UNKNOWN MANUFACTURER~4F51021~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~380956~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0063299	09/11/1995	NY	78.0	78		F	07/19/1994	pt recvd vax & w/in hrs devel urinary burning & frequency;persisted 2 1/2yrs;referred to urologist;APR93 macrodantin rx;sx resolved w/in 10 days;SEP93 recvd flu vax & 2 days later sx recurred & cont;MD states unrelated to vax									N	09/17/1993	09/19/1993	2	NA	PVT	PVT	Dilacor XR; PTU;Anaspaz		MD states on f/u I believe there is no relation of shot to symptoms.	pt exp urinary burning & frequency p/tetanus shot~ ()~~~In patient	940154501	1						2	Dysuria; Pollakiuria	FLU3~PFIZER\WYETH~359908~2~IM A~~INFLUENZA (SEASONAL) (FLU-IMUNE)~2	USA		Influenza
0081681	09/11/1995	AL	52.0			M	02/02/1994	pt recvd vax 3NOV93 & 6NOV presented w/flu sx described as chills,dizziness,cold sweat,weakness,heart palpitations;c/o rheumatoid arthritis flared & anorexia-weight loss of 14lbs;recovering;pt on multiple concomitant meds									Y	11/03/1993	11/06/1993	3	NA	PUB	OTH	NA	NA	NA	NA~ ()~~~In patient	940020901	1						1	Anorexia; Arthritis; Asthenia; Condition aggravated; Dizziness; Influenza; Palpitations; Weight decreased	FLU3~PFIZER\WYETH~361923~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0081682	09/11/1995	NY				U	02/18/1994	1 of 2 pts vaxed in SEP93 who exp flu (types A & B) in DEC93;no further clinical details available									Y	09/01/1993	12/01/1993	91	NA	OTH	OTH	NA		healthy	NA~ ()~~~In patient	940037701	1						1	Drug ineffective; Infection; Influenza	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0081683	09/11/1995	NY				U	02/18/1994	1 of 2 pts vaxed in SEP93 who exp the flu (type A & B) in DEC93;pt recovered;no further clinical details available									Y	09/01/1993	12/01/1993	91	NA	OTH	OTH	NA		healthy	NA~ ()~~~In patient	940037702	1						1	Drug ineffective; Infection; Influenza	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0081684	09/11/1995	AZ				M	06/27/1994	pt recvd flu vax 1991-1992;soon p/vax pt fainted & hit head (failed his bar exam several days following vax);no further details available									U				unk	PUB	PUB	unk	unk	unk	NA~ ()~~~In patient	940136201	1						1	Injury; Syncope	FLU3~LEDERLE LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0077406	09/15/1995	OR	41.0	41		M	09/14/1995	pt c/o redness in extremities & body-swelling in hands-tightness of throat making swallowing difficult; welts on back-turned to rash;									Y	09/13/1995	09/13/1995	0	NONE	PVT	PVT	Provental inhaler, ASA	faituge	allergic rhinitus, reactive airway disease; peptic ulcer disease	unk~ ()~~~In patient		1						1	Dysphagia; Laryngospasm; Oedema peripheral; Rash; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4958117~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0076061	09/29/1995	PR	68.0			F	07/07/1995	pt recvd vax & suffered a GBS rxn, causing pt to be paralyzed for 3 wks;problem reported to MFR on 7JUL95; pt needed to be intubated & tracheotomy performed			Y							08/26/1994	08/26/1994	0		UNK	UNK				~ ()~~~In patient		1						3	Guillain-Barre syndrome; Paralysis; Apnoea; Dyspnoea; Guillain-Barre syndrome; Paralysis; Guillain-Barre syndrome; Paralysis	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Life Threatening	Influenza
0077774	09/29/1995	TX	83.0			M	09/20/1995	pt recvd vax OCT94 & exp ascending paralysis & was hospitalized w/GBS from 1NOV94 until 19MAY95;event considered disabling;during hospitalization exp blood clot & a pulmonary embolus (MAR95);					Y	189			Y	10/01/1994	11/10/1994	40	14NOV94 Glucose; Protein 60; CSF no WBC; 17NOV94 Glucose, Protein 128, CSF 8WBCS; CT Scan & CSF r/o other etiologies	OTH	OTH	Nifedipine XL, Timolol, EC-ASA		Glaucoma, HTN	~ ()~~~In patient	0010150950200	1						1	Guillain-Barre syndrome; Paralysis; Pulmonary embolism; Thrombosis	FLU3~PARKE-DAVIS~00184P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0077835	10/02/1995	AK	63.0	63		M	09/22/1995	pt hosp 3wks p/vax for severe laryngeal stridor & paralysis of 9th, 10th, 11th cranial nerves, felt to be form of bulbar GBS; hosp x 9 days w/spontaneous recovery;					Y	9			Y	08/17/1995	09/09/1995	23		PVT	OTH	Hytrin, Capoten, Lasix,, Cadur	NONE	hypertension	~ ()~~~In patient		1						1	Facial palsy; Guillain-Barre syndrome; Myasthenic syndrome; Stridor	FLU3~PFIZER\WYETH~4958075~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1558A~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0077908	10/03/1995	AZ	69.0	69		F	09/25/1995	giant hives overlying area of immunization on lt deltoid;									U	09/19/1995				PVT	PVT				~ ()~~~In patient		1						1	Injection site hypersensitivity; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E2775HB~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~CONNAUGHT LABORATORIES~5C71114~1~~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0077945	10/10/1995	OR				U	10/06/1995	pt recvd vax & was later adm to hosp w/GBS which may be R/T flu virus; pt was on ventilator & has recvd a series of treatments w/plasmaphoresis					Y		Y		U					UNK	UNK				~ ()~~~In patient		1						1	Apnoea; Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0078002	10/10/1995	TX				F	09/28/1995	12:35 fainted in hallway-immed awoke-skin cool & clammy, lips pale-stated got SOB & that evening went blank; took back to school nurse & pt laid down; VS taken BP 118/70,P68, still cool & clammy;stated had not eaten lunch									Y	09/28/1995	09/28/1995	0		OTH	PVT			NONE	~ ()~~~In patient		1						1	Chills; Dyspnoea; Hyperhidrosis; Pallor; Syncope	FLU3~PARKE-DAVIS~00575P~UNK~SC~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0076391	10/11/1995	FL	54.0	54		F	10/05/1995	pt recvd vax;lt arm pain & some paralysis;back felt like it was on fire;could not sleep;could not eat solid foods;19oct to 1nov94 could not walk,could not swallow,arm paralyzed;face paralyzed;weakness,chronic fatigue;tx plasma pherises;			Y		Y	18			Y	09/30/1994	10/11/1994	11	CAT scan, MRI, Spinal tap;	OTH	OTH		last stages of cold		~ ()~~~In patient		1						2	Asthenia; Facial palsy; Guillain-Barre syndrome; Paraesthesia; Paralysis; Anorexia; Asthenia; Back pain; Dysphagia; Hypokinesia; Injection site pain; Insomnia; Paralysis	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~MEDEVA PHARMA, LTD.~E2504GC~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Life Threatening,Hospitalisation	Influenza
0078032	10/11/1995	OR	35.0	35		F	11/29/1994	immed onset of pain @ inj site 10NOV94 cont (unresolved) for next 6days when pt was seen by PMD who treated for arthralgia in rt arm (shoulder/elbow) w/steroid, DepoModral shot & oral antiinflamm;				Y					U	11/10/1994	11/10/1994	0	unk	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	OR9451	1						1	Arthralgia; Injection site pain	FLU3~CONNAUGHT LABORATORIES~4F51072~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~147AW~1~~LA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~4A61008~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0078034	10/11/1995	OR	62.0	62		F	11/04/1994	2hrs p/vax c/o watery eyes, lump in throat as afternoon progressed, eyes red, throat tight, cont get worst; no prob w/breathing; took DPH & gave some relief;				Y					Y	10/28/1994	10/28/1994	0	NONE	PUB	PVT	Premarin	NONE	NONE	~ ()~~~In patient		1						1	Conjunctivitis; Lacrimal disorder; Laryngospasm	FLU3~CONNAUGHT LABORATORIES~4F51024~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078036	10/11/1995	OR	26.0	26		F	10/31/1994	pt recvd vax 28OCT94 3PM et no sx or rx; that evening localized redness, achy joints 29OCT94-30OCT94 & today 31OCT94; reddness & itchy site the worse today 31OCT94 localized rxn approx 2x 1 1/2 lt arm										10/28/1994	10/29/1994	1		OTH	PVT		family was ill 2wks ago	PCN/sulfa; hx of Crohn's Disease-in remission; allergy to eggs	pt's sibling exp local in 1993 w/flu vax~ ()~~~In Sibling		1						1	Arthralgia; Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~4F51023~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078037	10/11/1995	OR	36.0			F	10/11/1994	had fever of 99.6 achy-also sore throat									Y	10/03/1994	10/03/1994	0	NONE	PUB	PVT		NONE	NONE	~ ()~~~In patient		1						1	Myalgia; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51165~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078039	10/11/1995	OR	67.0	67		F	09/16/1994	pt recvd vax 13SEP94 AM; 15SEP94 AM redness, swelling, warm to touch area 3 1/2 2 1/2 inj site; itching @ inj site 20SEP94										09/13/1994	09/15/1994	2		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51085~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078040	10/11/1995	OR	73.0	73		M	09/16/1994	redness & swelling-warm to touch @ inj site; 2 1/2 x 2 1/2 area; itching @ inj site 20SEP94;										09/13/1994	09/15/1994	2		UNK	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51085~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078066	10/11/1995	NJ	49.0	49		F	10/03/1995	pt calls ofc 2OCT95 w/c/o red, sore welt on buttocks where DT inj given;when seen by MD measured 8 x 4 w/central knot of 1 1/2 c 1 1/2;using warm compresses & oral ATB has f/u appt 5OCT95									U	09/28/1995	09/29/1995	1	NA	PVT	PVT	Lopid, Diabeta	prophylactic vax	NIDDM, chronic bronchitis; dyslipidemia	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51132~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~390936~UNK~~RA~PNEUMO (PNU-IMUNE)~1|TTOX~CONNAUGHT LABORATORIES~5F71086~UNK~~GM~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0078087	10/12/1995	OK	41.0	41		F	10/11/1995	pt recvd vax 6OCT95 & began w/h/a w/in 1-2 hrs had hard shaking chills, stomach cramps (severe) t105, diarrhea, trouble breathing;did not seek medical care @ time;only reported 11OCT95 to med dept to see pvt MD;feeling better now-weak;virus				Y					Y	10/06/1995	10/06/1995	0		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Abdominal pain; Asthenia; Chills; Diarrhoea; Dyspnoea; Headache; Infection; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61093~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078091	10/13/1995	MI	71.0			F	10/11/1995	pt recvd vax 13DEC94 & 24JAN95 devel acute gastroenteritis (camphylobacter);also devel disseminated intravascular coagulation (thrombotic), acute renal failure, & peripheral arterial embolization; pt was hospitalized on 28JAN95;					Y				U	12/13/1994	01/24/1995	42	unspecified dates-prothrombin time, partial thromboplastin time, fibrin split products, creatinine, BUN & CPK elevated; hemoglobin dec; MD reported too numerous to report;	UNK	OTH	Procardia, Synthroid, nasal spray		HTN, hypothyroidism	~ ()~~~In patient	0010150950213	1						1	Anaemia; Coagulopathy; Embolism; Gastroenteritis; Laboratory test abnormal; Renal failure	FLU3~PARKE-DAVIS~0027AP~UNK~SC~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0078092	10/13/1995	NY	56.0			M	10/04/1995	pt had coronary event 12 hrs p/vax autopsy showed only CAD-pt had sudden death clinically	Y								N	09/27/1995	09/28/1995	1		UNK	UNK	Micronase		no noted symptomatic heart disease-did have poorly controlled DM			1						1	Cardiac arrest; Coronary artery disease; Apnoea; Cardiac arrest; Coronary artery disease; Cardiac arrest; Cardiovascular disorder; Diabetes mellitus; Hepatic steatosis; Myocardial infarction; Pancreatitis; Respiratory disorder; Ventricular fibrillation	FLU3~PFIZER\WYETH~4958109~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4958109~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|FLU3~PFIZER\WYETH~4958109~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~3	USA	Results in Death	Influenza
0078109	10/13/1995	CA	79.0	79		F	10/03/1995	severe pain in neck & shoulders extending up to left ear & eye;				Y						09/23/1995	09/25/1995	2		UNK	PVT				~ ()~~~In patient		1						1	Arthralgia; Ear pain; Eye pain; Neck pain; Pain; Hypertonia; Myalgia; Myositis; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4958136~7+~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|TD~CONNAUGHT LABORATORIES~4J61014~UNK~~RA~TD ADSORBED (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0078115	10/13/1995	IL	68.0			F		pt arrived @ 10AM c/o swelling of lower lip p/flu shot;devel sneezing, cough, lip swelling;no tongue swelling; denied hx egg allergy; denied prior flu vax rxn;										09/27/1995	09/27/1995	0		UNK	UNK	Motrin, Ibuprofen, Atenolol, Isordil, ASH EC;		NKDA; no egg allergy;HTN, NIDDM, CAD/ s/p MI;	~ ()~~~In patient		1						1	Cough; Face oedema; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61119~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078116	10/13/1995	IL	41.0	40		F	10/04/1995	pt recvd vax 4OCT95 & devel urticarial rash on rt upper extremity & felt gen itching all over;given DPH; pt also exp SOB & chest pain;				Y					Y	10/04/1995	10/04/1995	0	PEFR 500; T97.6; BP 140/90;	PUB	OTH	ISORDIL, HCTZ, CARDIZEM, ELASA, AXID	NON-OBSTRUCTIVE CAD, DISCOID LUPUS	discoid lupus w/pulmonary involvement	~ ()~~~In patient		1						1	Chest pain; Dyspnoea; Pruritus; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~5F61119~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078136	10/16/1995	OH	31.0	31		F	10/05/1995	810AM pt c/o feeeling like cotton in throat, feeling like was going to vomit & heart was racing-HR 96 Epi given;pt felt was going to pass out; 8:20HR 90 sqad called 8:25HR 102 pt c/o feeling cold-tremulous, shivering-pt taken to hosp				Y					Y	10/05/1995	10/05/1995	0		OTH	UNK				~ ()~~~In patient		1						1	Chills; Dysphagia; Nausea; Syncope; Tachycardia; Tremor	FLU3~PFIZER\WYETH~4958114~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0078139	10/16/1995	MA	43.0	43		M	10/11/1995	gradual onset & offset of 24-48 hrs of mild nasal stuffiness, occasional sneezing, mildly but definitely clouded mentation, & mild physical ennervation; (mood fine, no rash, fever, arthralgia, diarrhea, abd pain, etc; mild cold									Y	10/02/1995	10/03/1995	1	NONE	PVT	UNK	NONE	NONE	NONE	pt exp rxn @ 42yrs w/ flu vax\~ ()~~~In patient		1						1	Asthenia; Pharyngitis; Rhinitis; Thinking abnormal	FLU3~CONNAUGHT LABORATORIES~5F61134~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078177	10/17/1995	OR	43.0	43		F	12/22/1994	pt reported malaise, fever 102, weakness, bad cough, lassitude; went to ER had been recovering from bronchitis (3wk hx)				Y					Y	12/13/1994	12/13/1994	0		PUB	PVT	Duracef	bronchitis	lupus, chronic liver disease, nona non b hepatitis, uterine CA, age 25 w/hysterectomy, thyroidectomy receives accpuncture	NA~ ()~~~In patient		1						1	Asthenia; Condition aggravated; Cough; Malaise; Pyrexia; Asthenia; Cough; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51024~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~4F51024~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0078184	10/17/1995	WI	27.0	26		F	10/13/1995	pt devel parethesias of rt arm, weakness, fatigue, hot flashes w/in 30mins of vax										10/12/1995	10/12/1995	0	NONE	OTH	UNK	NONE		NONE	~ ()~~~In patient		1						1	Asthenia; Paraesthesia; Vasodilatation	FLU3~PARKE-DAVIS~01185P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0078186	10/17/1995	TX	32.0	32		M	10/09/1995	sore throat, body aches & h/a; treatment will see PCP									U	10/03/1995	10/07/1995	4	NONE	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Headache; Myalgia; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~5F61119~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078189	10/18/1995	KS	74.0	74		F	10/12/1995	t101-102, chills, photophobia persistant, severe h/a & vomiting; admit 7OCT95-Tigan supp, MS IV, Compazine, IV fluids, Toradol, Xanax, Flexeril, APAP, Phenergan, Pred					Y	5			Y	10/02/1995	10/03/1995	1	WNL w/exceptions total bilirubin-1.3, CPK 8;	OTH	PVT	Vitamins, Melatonin, ultram, fosamax,zoloft, colace, pepcidac, ASA 81 mg	NONE	hepatitis JUL94, bilat mastectomies w/implants 25 yrs ago (1974)	~ ()~~~In patient		1						1	Arteritis; Cerebrovascular accident; Chills; Dehydration; Headache; Photophobia; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~02065P~5~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0078198	10/18/1995	IL	65.0	65		F	10/12/1995	pt devel itching & rash (like mosquito bites) lt arm @ site of flu vax inj w/in hrs of administration;									Y	10/11/1995	10/11/1995	0	NA	OTH	PVT	unk	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~4958132~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078199	10/18/1995	IL	58.0	58		F	10/12/1995	1 day p/vax pt went to ER w/vomitting & h/a;									Y	10/10/1995	10/11/1995	1	unk	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Headache; Vomiting	FLU3~PFIZER\WYETH~4958132~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~394963~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0078200	10/18/1995	CA	32.0	32		F	10/12/1995	pt started itching on upper body whives-inj site was very hot to the touch & swollen; pt was put on Claritin & Atarax; pt devel numbness of the lips & matallic taste on 5OCT95;pt able to return to work 6OCT95									Y	10/02/1995	10/04/1995	2		PVT	PVT		NA	NA	~ ()~~~In patient		1						1	Dysgeusia; Injection site oedema; Injection site reaction; Paraesthesia oral; Pruritus; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~4~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078205	10/18/1995	TX	53.0	53		F	10/13/1995	@1500 12OCT95 whelps @ site 3x7cm; 13OCT 7AM 5x10 cm whelp @ the site of the inj lt deltoid									U	10/12/1995	10/12/1995	0		MIL	PVT	unk	NONE	unk	~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~4958071~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078207	10/18/1995	CA	61.0	61		M	10/16/1995	nausea, malaise, h/a w/in 36hrs of inj; treated self w/stay-at-home rest; fever one degree above nl;pt later found had a URI @ time had vax									Y	09/18/1995	09/19/1995	1		PVT	PVT		UTI	environmental	~ ()~~~In patient		1						1	Headache; Malaise; Nausea; Pyrexia; Urinary tract infection	FLU3~CONNAUGHT LABORATORIES~~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078233	10/19/1995	NY	17.0	17		M	10/16/1995	pt recvd vax & 10 days later was evaluated by MD for sxs of Hodgkin's disease; pt has not recovered;pt cont to receive dose intensive chemotherapy;MD uncertain as to whether there is a relationship between flu vax & hodgkins disease					Y				N	10/13/1994	10/23/1994	10	unk	PVT	OTH	NONE		Epstein Barr virus	~ ()~~~In patient	0010150950214	1						1	Neoplasm	FLU3~PARKE-DAVIS~02504P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0078236	10/19/1995	MI	72.0	72		F	10/03/1995	pt recvd vax 315PM; 6-7PM devel dizziness when walking, near syncope, unable to maintain balance, fell and fractured rt radius; admitted to ER for tx & eval of syncoep;				Y	Y				Y	10/02/1995	10/02/1995	0	wrist still in cast unsure if related to vax or not	PVT	PVT	Copoten, Lasix	NONE	CAD, radiculopathy, NKA	NONE~ ()~~~In patient		1						1	Coordination abnormal; Dizziness; Injury; Syncope	FLU3~CONNAUGHT LABORATORIES~5F61006~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0078242	10/19/1995	FL	20.0	20		M	10/19/1995	fever, jittery, vomiting, h/a, arm hurts/sore				Y					N	10/18/1995	10/18/1995	0	NONE	PUB	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	FL95075	1						1	Headache; Nervousness; Pain; Pyrexia; Vomiting; Headache; Muscle twitching; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~5F61127~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0078247	10/19/1995	MN	26.0	26		M	10/06/1995	rt arm bright red, 4inches in diameter inj site slightly raised 1/2inch; very painful, sore mass, malaise, +1 edema									N	10/04/1995	10/04/1995	0		PUB	PUB	Vitamins	NONE	NONE	~ ()~~~In patient	MN95024	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Malaise; Oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078248	10/19/1995	IL	41.0	41		F	10/12/1995	1:00 recvd vax & @ 4:00 itchy eyes, gooey (eyes), achy body, tongue is tingling;									N	10/12/1995	10/12/1995	0	NONE	PUB	PVT	Synthroid, Orthosept	NONE	NONE	NONE~ ()~~~In patient	IL950113	1						1	Conjunctivitis; Myalgia; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078249	10/19/1995	NC	41.0	41		F	10/16/1995	nausea, diarrhea, since vax									N	10/14/1995	10/14/1995	0	unk	PUB	PUB	NONE	NONE	allergic to codeine & Neosporyn/allergies	NONE~ ()~~~In patient		1						1	Diarrhoea; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078250	10/19/1995	MO	67.0	67		F	10/18/1995	5hrs post vax flu like sxs, chills, sick feeling, aching (went to bed) better later in day									Y	10/17/1995	10/17/1995	0	NONE	PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Chills; Malaise; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078259	10/19/1995	IA	38.0	38		F	10/17/1995	h/a, body ache, sore throat, cramping, queasiness									U	10/17/1995	10/17/1995	0	NONE	OTH	OTH	NONE	NONE	allergic to PCN	~ ()~~~In patient		1						1	Headache; Hypertonia; Myalgia; Nausea; Pharyngitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078262	10/19/1995	NJ	75.0	75		F	10/14/1995	running nose, throat irritation from Friday 8OCT95 till 10OCT95 never had temp									Y	10/02/1995	10/06/1995	4		UNK	UNK	Primival, Normodyme, vitamin,			~ ()~~~In patient		1						1	Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078215	10/20/1995	TN	78.0	78		M	10/12/1995	p/vax 6OCT95 pt became confused, could not talk, was sweating & pale sxs lasted 24 hrs;									Y	10/06/1995	10/06/1995	0	NONE	PUB	PUB	Mil	NONE	black lung	NA~ ()~~~In patient	TN95107	1						1	Confusional state; Hyperhidrosis; Pallor; Speech disorder	FLU3~CONNAUGHT LABORATORIES~5F61126~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~390933~1~IM~RA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~4G61080~UNK~IM~LL~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0078219	10/20/1995	MO	59.0	59		F	10/17/1995	sore mouth, myalgia, low grade fever, photophobia, perifollicular palpable lesions of arms, legs, chest,itching;eventually required Pred, Periactin;				Y					U	10/02/1995	10/04/1995	2	NONE	PVT	PVT	Premarin, Provera	NONE	allergic rhinitis, osteoporosis, multiple antibiotic allergies	NA~ ()~~~In patient		1						1	Ecchymosis; Myalgia; Photophobia; Pruritus; Pyrexia; Rash maculo-papular; Serum sickness; Stomatitis	FLU3~CONNAUGHT LABORATORIES~5F61082~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078220	10/20/1995	WI	24.0	24		F	10/13/1995	pt recvd vax 1230PM on 12OCT95 c/o immed numbness & pain in rt wrist p/vax;seen 3 hrs later & felt achy, feverish & had hot flashes;had cont numbness to rt upper arm;				Y					Y	10/12/1995	10/12/1995	0	NONE	OTH	OTH	Hismanal, Orthonovum 1/35	NONE	NONE	NONE~ ()~~~In patient		1						1	Hypoaesthesia; Myalgia; Pain; Pyrexia; Vasodilatation	FLU3~PARKE-DAVIS~01185P~4~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0078223	10/20/1995	PA				U	10/09/1995	achy all over, still hurt @ this time 9OCT95 taken APAP; flu sxs thigh leg's-arms hurt									N	10/03/1995	10/04/1995	1		PUB	UNK	Synthroid, KDUR	NONE	NONE	~ ()~~~In patient		1						1	Influenza; Myalgia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078229	10/20/1995	MN	49.0	49		F	10/14/1995	flu sxs 5OCT95 went to work sickness came on 1st hr, diarrhea, chills, sweats, urge to throw up, faintness, white as a ghost;went home felt better later afternoon 5OCT95									Y	10/02/1995	10/05/1995	3	NONE	OTH	PVT	Premarin	NONE	NONE	NONE~ ()~~~In patient		1						1	Chills; Diarrhoea; Hyperhidrosis; Influenza; Nausea; Pallor; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078268	10/23/1995	MN	12.0	12		M	10/19/1995	given vax & passed out 3mins later; No sz activity but initially difficult to get pulse & no breathing (for about 30-60 sec);			Y						Y	10/05/1995	10/05/1995	0	NONE	PVT	PVT	NONE	NONE	prev GBS	~ ()~~~In patient		1						1	Apnoea; Bradycardia; Syncope	FLU3~PFIZER\WYETH~4958074~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening	Influenza
0078286	10/23/1995	NY	48.0	48		M	10/12/1995	pt recvd flu vax 1130AM 7OCT95-approx 130AM 8OCT95 pt exp shaking, chills, gen body aching lasting approx 1hr-by 8AM 8OCT, chills gone, aching subsiding, by 12noon, sxs gone-no residula effects									Y	10/07/1995	10/08/1995	1	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	NYS95056	1						1	Chills; Myalgia; Tremor	FLU3~PARKE-DAVIS~00885P~5~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0078287	10/23/1995	MA	63.0			F	10/13/1995	11OCT95 230PM burning cheeks, 3PM flushing, blotching of face-upper chest; psoriasis lesions, inc red; gen pruritus by 4PM; 6PM nasal congestion-took dimetapp sxs subsided @ 10PM;									Y	10/11/1995	10/11/1995	0		PUB	PUB	Premarin, Provera, Psorcon, Antabuse	psoriasis-hands & elbows	hair dye-grass-cats-dogs-smoke	~ ()~~~In patient	MA9507	1						1	Pain; Pruritus; Psoriasis; Rhinitis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61134~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0536A~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0078290	10/23/1995	WI	50.0	49		M	10/19/1995	fever, cough, congestion, SOB, eyes swelled shut-last about 12 hrs-pt did not seek any medical help-called clinic to inform when was back to nl									Y	10/16/1995				PVT	UNK	NONE	NONE	hyperlipidemia	NONE~ ()~~~In patient		1						1	Cough; Dyspnoea; Face oedema; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61126~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078109	10/24/1995	CA	79.0	79		F	09/28/1995	had recvd vax & arms little sore on awoken on Mon w/shoulders & neck stiff & very painful;No fever unable to sleep lying down d/t pain & soreness;no h/a; had inflammation of muscles & gave muscles relax & Aleve for pain				Y					Y	09/23/1995	09/25/1995	2	NA	PUB	PUB	Zantec for ulcers	NONE	has ulcers	NA~ ()~~~In patient	CA95119	1						2	Arthralgia; Ear pain; Eye pain; Neck pain; Pain; Hypertonia; Myalgia; Myositis; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4958136~7+~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|TD~CONNAUGHT LABORATORIES~4J61014~UNK~~RA~TD ADSORBED (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0078297	10/24/1995	MN	90.0	90		M	10/16/1995	guillain-Barre synd-hypokalemia	Y		Y		Y				N	10/02/1995	10/13/1995	11		PVT	PVT	NONE			~ ()~~~In patient		1						1	Guillain-Barre syndrome; Hypokalaemia	FLU3~PFIZER\WYETH~4958074~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~390928~UNK~~LA~PNEUMO (PNU-IMUNE)~1	USA	Results in Death	Influenza
0078302	10/24/1995	KY	79.0	78		M	10/20/1995	diff breathing, loss of appetite, fever, weakness, disorientation			Y	Y	Y	4			N	10/13/1995	10/14/1995	1		OTH	OTH		ear infect	diabetes, hypertension	~ ()~~~In patient		1						1	Anorexia; Asthenia; Confusional state; Dyspnoea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0078310	10/24/1995	CA	69.0	69		F	09/28/1995	c/o severe abd pain, hyptension, BP 70/50, pulse 68, cold, clammy, diaphoretic 911 called-taken to ER-released p/several hrs in ER; saw PMD next day & given ulcer medication				Y					Y	09/25/1995	09/25/1995	0	No lab test done	PUB	PUB	Pepcid	peptic ulcer disease; inc BP	peptic ulcer, hypertension	~ ()~~~In patient	CA95123	1						1	Abdominal pain; Chills; Hyperhidrosis; Hypotension	FLU3~CONNAUGHT LABORATORIES~5F61119~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078312	10/24/1995	CA	44.0	44		M	10/11/1995	97.8 nl temp; late afternoon on 9OCT95 devel t102 by 2nd day w/APAP q 4 to 6 hrs;red arm-ice to are starting 11OCT95; 12OCT95 redness less some congestion, asthma;									Y	10/09/1995	10/11/1995	2	NONE	OTH	PUB		NONE	asthma-for 1 1/2yr-inhaler (proventil) PRN	NONE~ ()~~~In patient	CA95127	1						1	Asthma; Condition aggravated; Pharyngitis; Pyrexia; Rhinitis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61119~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1541A~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0078321	10/24/1995	OH	53.0	52		F	10/16/1995	approx 1/2 to 1 hrs p/vax exp h/a & itching all over;did not call to report this until 315PM;referred to ED				Y					Y	10/16/1995	10/16/1995	0		MIL	PVT	NONE		allergy Ibuprophen dye for xrays; IVP dye	NONE~ ()~~~In patient		1						1	Headache; Pruritus	FLU3~PFIZER\WYETH~4958078~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0078330	10/24/1995	TX	42.0	42		F	10/18/1995	became extremely congested, unable to breath well, severe h/a, sore throat;throat felt like it was closing;lips swollen, high BP; fast pulse; ER-Epinephrine-DPH-Pred				Y					Y	10/06/1995	10/06/1995	0		OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Dyspnoea; Face oedema; Headache; Hypertension; Laryngospasm; Pharyngitis; Rhinitis; Tachycardia	FLU3~CONNAUGHT LABORATORIES~5F61006~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078334	10/24/1995	NY	33.0	33		F		c/o generalized itching; feeling of fullness in lips; feeling of puffiness in eyes;				Y					Y	10/17/1995	10/17/1995	0	NONE	OTH	PVT	NONE	NONE	allergy to sulfur/multiple other allergies	~ ()~~~In patient		1						1	Face oedema; Pruritus	FLU3~PFIZER\WYETH~4958076~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0078336	10/24/1995	IN				F	10/19/1995	fever up to 102 x 5d; redness & swelling @ inj site; n/v x 5 days w/myalgias; as of 19OCT, deltoid tenderness w/swelling persists				Y					N	10/12/1995	10/13/1995	1		PVT	PVT	Ventolin inhaler	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia; Nausea; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~5F61093~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~394959~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0078338	10/24/1995	NJ	39.0	39		F	10/18/1995	approx 48hrs burning sensation, sl raised redness in area of shot, size approx of an orange;unable to sleep on that arm 1st noc;skin hot to touch x 48hrs; took ASA, DPH									Y	10/12/1995	10/12/1995	0	NONE	PUB	PUB		NONE	NONE	~ ()~~~In patient	NJ9545	1						1	Injection site hypersensitivity; Injection site oedema; Pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078341	10/24/1995	MA				U		pt recvd vax & exp vomiting & diarrhea;									Y	10/03/1995	10/04/1995	1		PUB	UNK				~ ()~~~In patient	MA9509	1						1	Diarrhoea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078342	10/24/1995	KS	36.0	36		F	10/16/1995	site of inj was painful & began to swell & get hard;2hrs p/vax rt deltoid w/in 24hrs of redness & swelling had inc to the diameter of a softball;By 72 hrs, redness & swelling were decreasing but area of ecchymosis appeared & is resolving;									Y	10/11/1995	10/11/1995	0	NA	PUB	PVT	NONE	NONE	allergic PCN	NA~ ()~~~In patient		1						1	Ecchymosis; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4958129~2~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078343	10/24/1995	NY	72.0	72		F	10/19/1995	pt had pneumonia vaccine @4PM & last evening devel RUE warm, itch & swelling @ site of inj; pt was seen 19OCT95 1115 & prescirbed Atarax;pt was seen 19OCT95 1115 & prescribed Atarix									U	10/18/1995	10/18/1995	0	NONE	PVT	OTH	synthroid, Oruvail, Fluoxymestrone	NONE	mastectomy rt= moderate	~ ()~~~In patient		1						1	Injection site oedema; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4958113~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1559A~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0078348	10/24/1995	NC	42.0	42		F	10/16/1995	1. x 0.5cm clear raised blister @ site of inj which occurred 1 wk p/inj									Y	10/06/1995	10/13/1995	7	NONE	OTH	PVT		NONE		~ ()~~~In patient		1						1	Injection site reaction	FLU3~PFIZER\WYETH~4958107~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078358	10/24/1995	VA	44.0	44		F	10/20/1994	pt recvd vax 530PM severe rash occured 1145PM;tightness in chest; 2 DPH given immed 15mins later pt fell asleep; in the AM everything was OK;										10/06/1994	10/06/1994	0		UNK	UNK			no smoker; no alochol in 6wk prior; allergies PCN & Iodine	~ ()~~~In patient		1						1	Rash	FLU3~PFIZER\WYETH~4948182~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078361	10/24/1995	NC	60.0	60		M	10/24/1995	flu like sxs: gastro problems, upper resp prob; body aches, joint pain, elevated temp, malaise									N	10/19/1995	10/22/1995	3	NONE	OTH	OTH	Pred, Plaquenil	NONE	systemic lupus (SLE)	NONE~ ()~~~In patient		1						1	Abdominal pain; Arthralgia; Influenza; Malaise; Myalgia; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61144~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078367	10/24/1995	TX	58.0	58		F	10/20/1995	w/in 72hrs pt devel 15x10cm purple, tender bruised area of the rt arm site of inj; med Premarin, calcium channel blocker;									U	10/10/1995	10/10/1995	0	NA	PVT	PVT	Premarin, Calcium channel blocker, ASA	NONE	ischemia heart dz (h/o heart attack)	NONE~ ()~~~In patient		1						1	Ecchymosis; Injection site hypersensitivity; Injection site pain	FLU3~CONNAUGHT LABORATORIES~016659~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078370	10/24/1995	CA	75.0	75		F	10/18/1995	erthematous, rash on vax site oval shap around 3inch by 7inch along fore arm; no general sxs noted, also mild pruritus									Y	09/25/1995	09/26/1995	1	NONE	PVT	PVT	Premarin; APAP	HTN, menopausal, Nicotine dependency	no medication allergies	~ ()~~~In patient		1						1	Pruritus; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~5F61143~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078375	10/24/1995	MO	79.0	79		F	10/19/1995	stated nurse gave inj too high on lt arm causing what pt is sure is nerve damage; had funny sensation go up arm & neck w/puncture; has had cont pain since which is not relieved w/Ibuprofen; has not yet seen MD when event reported in 19OCT95										10/04/1995	10/04/1995	0		OTH	PVT	unk	NONE	NONE	~ ()~~~In patient		1						1	Neuropathy; Pain	FLU3~PFIZER\WYETH~4958124~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078378	10/24/1995	OH	67.0	67		M	10/18/1995	site where flu vax was given deltoid 3x4 red area, warm to touch, raised area; area reddness & induration resolved									Y	10/16/1995	10/18/1995	2		MIL	PVT	ASA	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4958078~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078379	10/24/1995	PA	65.0	65		F	10/20/1995	7cm area of erythema, swollen & warm to touch local rxn;									Y	10/17/1995	10/17/1995	0		UNK	UNK	Zantac, Premarin	NONE	gastric reflux	pt exp rxn in 1994 w/flu vax very tired, slept 15 hrs~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~5F61117~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078382	10/24/1995	OH	29.0	29		M	10/20/1995				Y						U	10/13/1995			unk	PUB	PUB	Zolfol, Clarsic, Pracradic	flu		~ ()~~~In patient		1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0078383	10/24/1995	MA				U		12 hrs p/shot pt went into diabetic coma & was hospitalized for 3 days p/leaving the hosp devel optic disk edema & is now experienceing focal szs;					Y	3				10/23/1984				OTH	OTH		insulin dependent diabetes	insulin dependent diabetes	~ ()~~~In patient		1						1	Convulsion; Diabetic coma; Eye disorder	FLU3~PFIZER\WYETH~4848206~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0078393	10/26/1995	MI	48.0	48		F	10/24/1995	pt first noticed one tender, enlarged lt mid-supraclavicular lymph node 1 day p/vax;node evaluated on 19OCT95 & was found to be slightly tender, mobile & approx 1-2cm in diameter;24OCT95 above node was no longer palpable;				Y					Y	10/16/1995	10/17/1995	1	NONE	OTH	PVT	Sudafed, Seldane	hx of sinus problems	allergic to shellfish, nuts, dust, pollen & dog; prev dx bronchial asthma	~ ()~~~In patient		1						1	Lymphadenopathy; Pain; Lymphadenopathy; Pain	FLU3~PARKE-DAVIS~00885P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00885P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0078398	10/26/1995	CT	53.0	53		F	10/21/1995	ears hurt (achy & feverish feeling on outside of ears, but not fever); laryngitis-congestion-hacky cough-felt very ill lasting 2 wks took Biaxin & Advil;still not completely free of sxs;									U	10/06/1995	10/06/1995	0		PVT	UNK	Estrogen, Proventil		systemic problems-silicone breast implants for 12 1/2yrs	~ ()~~~In patient		1						1	Cough; Ear pain; Laryngitis; Malaise; Myalgia; Pharyngitis; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078399	10/26/1995	WI	30.0	30		F	10/25/1995	real dizziness almost to fainting; dry throat & mouth; dizziness followed by h/a & upset stomach									N	10/24/1995	10/24/1995	0	NONE	OTH	OTH	Triphasil birth control	NONE	NONE	NONE~ ()~~~In patient		1						1	Dizziness; Dry mouth; Dyspepsia; Headache; Syncope	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078402	10/26/1995	MO	31.0	31		M	10/25/1995	pt glassy eyes, watery eyes, very tired, ataxic									Y	10/24/1995	10/24/1995	0	NONE	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Asthenia; Coordination abnormal; Lacrimal disorder; Stupor	FLU3~CONNAUGHT LABORATORIES~5F61115~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078404	10/26/1995	VA	69.0	69		F	10/25/1995	arm red, sore, 3 x 2 3/4 daim burning, pain between shoulder & elbow; large round burn look, hot to touch				Y					N	10/17/1995			NONE	OTH	UNK	Librium Diaside, Premarin	NONE	NONE	~ ()~~~In patient		1						1	Pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0078406	10/26/1995	AZ	76.0	76		F	10/25/1995	exp very severe h/a, ear pressure, neck pain, nausea, diarrhea x 3, vomited; slept took Ibuprofen x 3										10/20/1995	10/24/1995	4		PVT	OTH	NONE	NONE	multiple chemical sensitivities, food allergies, carpal tunnel	~ ()~~~In patient		1						1	Diarrhoea; Headache; Nausea; Pain; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078407	10/26/1995	NC	9.0	9		M	10/26/1995	rash similar to hives appeared on thighs to ankle									N	10/19/1995	10/20/1995	1	NONE	PVT	PVT	Ventolin syrup		asthma-allergies (severe)	pt exp rxn w/DTP~ ()~~~In patient		1						1	Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078408	10/26/1995	NC	39.0	39		F	10/26/1995	rash similar to hives-collar bones arms-elbow down-hands & face				Y					N	10/13/1995	10/14/1995	1	NONE	PVT	PVT	Provental Repitabs, Lotensin, Hydrochlrothiazide, Intex AL, Claritan	bronchitis	asthma-allergies (severe)	NONE~ ()~~~In patient		1						1	Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0078925	10/26/1995	MA	76.0	76		F	10/24/1995	cough, sneeze, head bad cold, malaise									Y	10/25/1995	10/25/1995	0		PUB	UNK	Vasotec, Lodine, HydroChlorathyide	NONE	PNC-hypertension, osteo arthritis, bronchial asthma when contracting a head cold	~ ()~~~In patient		1						1	Cough; Malaise; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078092	10/27/1995	NY	56.0	56		M	09/29/1995	pt recvd flu vax & 13hrs later pt died of a cardiac arrest;reporter believes this event is unrelated to flu vax;	Y	09/28/1995							N	09/27/1995	09/28/1995	1	autopsy revealed coronary artery disease	PVT	OTH	ASA, Micronase tablets;	unk	pt had chronic diabetes		895275004L	1						2	Cardiac arrest; Coronary artery disease; Apnoea; Cardiac arrest; Coronary artery disease; Cardiac arrest; Cardiovascular disorder; Diabetes mellitus; Hepatic steatosis; Myocardial infarction; Pancreatitis; Respiratory disorder; Ventricular fibrillation	FLU3~PFIZER\WYETH~4958109~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4958109~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|FLU3~PFIZER\WYETH~4958109~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~3	USA	Results in Death	Influenza
0078409	10/27/1995	MA	45.0	45		F	10/16/1995	w/in 3hrs exp numbness of lips-hoarseness flushing-temp inc-red eyes-red throat-went to ER @ hosp was given Epi & Pred inj & script for Pred decreasing dose pack &  DPH;next day eyes clear, throat ok, pounding, h/a, red face, hot flashes				Y					Y	10/12/1995	10/12/1995	0		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MA9508	1						1	Conjunctivitis; Dysphonia; Headache; Hypoaesthesia; Pharyngitis; Pyrexia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~5F61134~4~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~1558A~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0078411	10/27/1995	MI	79.0	79		M	10/11/1995	pt recvd vax @ noon;noted red/swelling arm 1/2hr later cont to swell;pt wife call MD ofc & was seen 4-430PM;given Medrol;swelling devel 4-5 circle around inj & extended down to elbow red, hard to touch & warm				Y					Y	10/10/1995	10/10/1995	0	BP 160/92 (high for client); T97.3	PUB	PUB	Lisinopril;Zesteril; Xanax;Kuzime	NONE	high blood pressure (140/90 usual reading while on meds);	NONE~ ()~~~In patient	MI95110	1						1	Hypertension; Injection site hypersensitivity; Injection site mass; Oedema peripheral	FLU3~PFIZER\WYETH~4958114~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~378977~2~SC~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0078412	10/27/1995	MI	60.0	60		F	10/11/1995	5OCT95 530AM pt noticed rash near rt elbow; 6OCT & 7OCT rash had progressed to torso;pt noticed hands had begun to swell & sun am 18OCT95 went to ER; Atarax;seen by MD; hives diminished				Y					U	10/04/1995	10/05/1995	1	No blood drawn @ ER	PUB	PUB	Levothyroid, Prilosec, Tagamet		sporadic stomach problems last 5 mos; partial thyroidectomy 30yrs ago	~ ()~~~In patient	MI95111	1						1	Oedema peripheral; Rash; Urticaria	FLU3~PFIZER\WYETH~4958114~6~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0078416	10/27/1995	MI	50.0	50		F	10/06/1995	lt upper arm around inj site; 2 1/2-3 inches (diameter) swollen, reddened hard (per patient)									Y	10/04/1995	10/06/1995	2	NONE	PUB	UNK	NONE		NONE	~ ()~~~In patient	MI95116	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~PFIZER\WYETH~4958114~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078417	10/27/1995	MI	57.0	57		F	10/12/1995	pt recvd vax 230PM 10OCT95 & exp arm soreness;next morning devel raised welts which itched appeared to be hives;applied alcohol to area & an ATB cream;no addtl hives devel & had disappeared by 12OCT95;saw MD on 12OCT;									Y	10/10/1995	10/10/1995	0		PUB	PUB	NONE	NONE	PCN-codeine-Caffeine-steroids-adhesive tape	~ ()~~~In patient	MI95117	1						1	Myalgia; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4958114~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078419	10/27/1995	MI	53.0	52		F	10/13/1995	pt recvd vax 9OCT95 in lt delotid on 11OCT pt states lt & rt legs started aching severly on 12OCT in the AM started experiencing low mid section backache;saw MD on 13OCT;BP was 130/84; no other problems noted; MD informed pt to contact clic				Y					N	10/09/1995	10/11/1995	2	NONE	PUB	PUB	Norvasc;Paxil	recovering from cold-no fever	HTN	NONE~ ()~~~In patient	MI95119	1						1	Back pain; Myalgia	FLU3~PFIZER\WYETH~4958114~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0078420	10/27/1995	MI	63.0	63		F	10/13/1995	pt recvd vax 11OCT95 in lt deltoid started seein rx 13OCT95 states posterior & anterior upper lt arm is red & hot to touch;site of inject swollen to size of orange;no rash or difficulty breathing;PHN instructed pt to TC personal physician									Y	10/11/1995	10/13/1995	2	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MI95120	1						1	Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4958114~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078422	10/27/1995	NJ	50.0	50		F	10/20/1995	lt upper arm around inj site, red itching & warm also red rash on lt shoulder, scapula & neck;started last noc				Y						10/19/1995	10/19/1995	0	NONE	PUB	UNK		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Rash	FLU3~PFIZER\WYETH~4958119~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0078424	10/27/1995	NY	49.0	49		F	10/17/1995	redness, swelling & hardness @ inj site on lt arm 13OCT95; fever on Saturday 14OCT95; took APAP for pain & saw PCP on 16OCT95;				Y					Y	10/13/1995	10/13/1995	0	NONE	OTH	OTH	Synthroid	NONE	underfunctioning of thyroids	pt exp rxn @ 26-28yrs old w/flu vax dose 1~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pain; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E2745HB~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0078430	10/27/1995	TX	26.0	26		F	10/20/1995	erythemia, swelling, numbness from fingers to armpit, tenderness, h/a, nausea, cellulitis; given Decadron & Cephalexin & ATB x 5 days;				Y					Y	10/19/1995	10/19/1995	0		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Cellulitis; Headache; Hypoaesthesia; Nausea; Oedema peripheral; Pain; Rash	FLU3~CONNAUGHT LABORATORIES~5F61082~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078432	10/27/1995	MO	48.0	47		F	10/19/1995	w/in 2 hrs, severe itching & swelling of eyes, runny nose; next morning, red eyes, stinging, burning, runny nose, achiness, neck nodes swollen, t98.2;									U	10/18/1995	10/18/1995	0		PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Conjunctivitis; Eye pain; Face oedema; Lymphadenopathy; Myalgia; Pruritus; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5J61007~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078433	10/27/1995	MI	32.0	31		F	10/20/1995	pt recvd vax approx 30mins p/vax c/o hot flashes states felt sl nausea which subsided p/ate a cookie; face, neck, upper trunk & arms flushed-bright pink in color;color remained 1-2 hrs p/but pt states feels OK									Y	10/20/1995	10/20/1995	0	NA	PUB	PUB	NONE	NONE	?allergy to PCN	~ ()~~~In patient	MI96008	1						1	Nausea; Vasodilatation	FLU3~PFIZER\WYETH~4958108~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078448	10/27/1995	IA	83.0	83		F	10/18/1995	reports inj site painful shortly p/vax given;later noted itching, pain, redness & swelling, (diameter 4-5 x 6 upper rt arm @ worst);gradually subsided contacted by phone 18OCT95 nearly all gone no tx									Y	10/10/1995	10/10/1995	0	NONE	PUB	PUB	Norvasc	NONE	HTN	~ ()~~~In patient	IA95040	1						1	Injection site pain; Oedema peripheral; Pain; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4958114~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~4H61119~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0078242	10/30/1995	FL				M	10/19/1995	1030PM pt had vomiting, fever 101, felt jittery, took APAP relief;early this morning vomited again, persistent h/a;23OCT95 pt states recovered & feeling fine									Y	10/18/1995	10/19/1995	1		PUB	PVT		NONE	NONE	NA~ ()~~~In patient		1						2	Headache; Nervousness; Pain; Pyrexia; Vomiting; Headache; Muscle twitching; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~5F61127~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0078449	10/30/1995	PR	52.0	52		F		muscular pain, chest pain & muscular rigidity;pain in the entire body, fever, diarrhea & nausea;									Y	10/07/1995	10/07/1995	0	NA	PUB	PUB		NA	allergies APAP, ASA, Ibuprofen	NA~ ()~~~In patient		1						1	Chest pain; Diarrhoea; Hypertonia; Myalgia; Nausea; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0078453	10/30/1995	CA				M	10/10/1995	pt recvd vax & devel poss complications of the pre-existing COPD & was hospital;addtl info recvd 13OCT95 revealed that pt died while in hosp	Y				Y				N					OTH	OTH	unk	COPD	COPD	~ ()~~~In patient	895289005S	1						1	Condition aggravated; Embolism; Hyperventilation; Hypotension; Infection; Pneumonia; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0078454	10/30/1995	CA				U	10/11/1995	pt recvd vax & was hospitalized w/poss dx of pneumonia; addtl info recvd 13OCT95 revealed that the pt's admission dx of pneumonia was confirmed & pt recvd IV ATB;					Y				U					OTH	OTH	unk	COPD		~ ()~~~In patient	895289006S	1						1	Asthma; Chest pain; Dyspnoea; Hypertension; Infection; Laryngospasm; Paraesthesia; Pneumonia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0078455	10/30/1995	NY	74.0	74		F	10/04/1995	pt recvd vax 18SEP95 & 30SEP95 exp confusion, agitation & T101-102;adm to hosp lab work-up revealed white count of 16,000/cumm which inc to 20,000/cumm;dx brain stem infarction vs encephalopathy d/t flu shot vs meningitis				Y	Y				U	09/18/1995	09/30/1995	12	WBC admission 16,000/cumm-repeat 20,000/cumm; LP WBC/REC none/none-protein 77mg%; CT Scan nl	PVT	PVT	Digoxin tablets; Lasic tablets	unk	HTN	~ ()~~~In patient	895279002L	1						1	Agitation; CSF test abnormal; Cerebral infarction; Confusional state; Encephalopathy; Leukocytosis; Meningitis; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0078461	10/30/1995	NC	61.0	61		F	10/23/1995	5OCT95 vax given;20OCT95 hospitalized for muscle weakness; 22OCT95 dx w/GBS			Y		Y		Y		N	10/05/1995	10/20/1995	15	guillian Barre synd	PUB	UNK	antihypertensives and hypoglycemia meds	unk	unk	~ ()~~~In patient	NC95109	1						1	Gait disturbance; Guillain-Barre syndrome; Myasthenic syndrome; Neuropathy	FLU3~CONNAUGHT LABORATORIES~5F61145~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0078463	10/30/1995	OK	63.0	63		F	10/30/1995	nausea, fever, chills, sore throat, throat sore to touch-top of mouth sore, head cold			Y						Y	10/24/1995	10/25/1995	1	NONE	PUB	PUB	NONE	NONE	allergic to beef & pork/dairy products	~ ()~~~In patient		1						1	Chills; Nausea; Pain; Pharyngitis; Pyrexia; Rhinitis; Stomatitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0078466	10/30/1995	MI	63.0	62		M	10/27/1995	exp weakness of legs-until could not walk; dx'd GBS			Y	Y	Y	10		Y	N	10/06/1995	10/12/1995	6		PUB	PUB	Procardia inhaler	NONE	heart problems	NONE~ ()~~~In patient	MI96009	1						1	Guillain-Barre syndrome; Hypokinesia; Hypotonia	FLU3~PARKE-DAVIS~00295P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0078477	10/30/1995	NC	68.0	68		F	10/24/1995	23OCT95 pt woke up & noticed had red swollen area @ site of inj of Td;stated area felt feverish & was painful;redness ran all the way down half of lt arm;MD dx'd allerg rxn				Y					Y	10/16/1995	10/23/1995	7		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	NC95111	1						1	Hypersensitivity; Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61014~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~4G61080~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0078479	10/30/1995	NC	42.0	42		F	10/18/1995	2hrs p/vax pt has SOB & diff breathing, had tingling & swelling of mouth & lips;took Alupent & DPH;also exp hives & ha/				Y					Y	10/17/1995	10/17/1995	0		PUB	PUB	Pred; B12, Lopressor, Plaquen,Clonopin, Hactinzia	NONE	connective tissue disease; allergic to feathers	pt exp similar rxn to medicines w/ASA before~ ()~~~In patient	NC95108	1						1	Dyspnoea; Face oedema; Headache; Hepatomegaly; Laboratory test abnormal; Paraesthesia; Urticaria	FLU3~CONNAUGHT LABORATORIES~5F61149~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078482	10/30/1995	NC	31.0	30		F	10/16/1995	pt recvd vax & exp fever 100-101, pain in rt arm extending to fingertips;arm was ore several days;pt nauseated; had gen aching; pt is a diabetic									Y	10/12/1995	10/12/1995	0		PUB	PUB	Insulin	NONE	diabetic	~ ()~~~In patient	NC95105	1						1	Myalgia; Nausea; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61149~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1558A~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0078488	10/30/1995	WA	48.0	48		F	10/19/1995	pt recvd vax & later in afternoon arm became sore, was very sore by evening;next day 18OCT95 was tired, arm very sore, noticed rash on upper arm & swollen lymphnode under arm;rash is red extending from upper arm almost elbow & under arm;				Y					Y	10/17/1995	10/17/1995	0		PUB	PUB			pre-lupis condition	~ ()~~~In patient	WA951171	1						1	Asthenia; Lymphadenopathy; Myalgia; Rash	FLU3~PFIZER\WYETH~4958119~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~380957~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0078491	10/30/1995	WI	46.0	46		F	10/23/1995	lt arm swelling to wrist;baseball sized swelling @ site 1/2 raised higher than other swelling, red, fire, hot;iced arm & site;baseball area became very itchy, w/hives in that area only;area not bruised;felt sicker & sicker w/nausea 19OCT95									N	10/18/1995	10/19/1995	1		PUB	PVT	NONE	NONE	allergy to paper tape	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Malaise; Nausea; Oedema peripheral; Pruritus; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4958074~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078494	10/30/1995	CA	50.0	50		M	10/16/1995	13OCT95 reports t100.6, BP 160/101, P91, R20 advised to take APAP; no problems breathing, no hives, no body aches;1hr later t102.4 went as high as 103; arm red, warm to touch, w/swelling of a couple inches @ inj site;									Y	10/13/1995	10/14/1995	1	NA	PUB	PVT	Tetracycline	NONE		~ ()~~~In patient		1						1	Hypertension; Injection site hypersensitivity; Injection site oedema; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4958126~3~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~394959~1~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0078495	10/30/1995	IL	59.0	59		M	10/21/1995	severe chills 12 hrs p/inj followed by myalgia & fatigue									Y	10/20/1995	10/20/1995	0	NONE	PUB	PUB	HCTZ	HTN	allergy to PCN/HTN	NA~ ()~~~In patient	IL950117	1						1	Asthenia; Chills; Myalgia	FLU3~CONNAUGHT LABORATORIES~5F61098~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078499	10/30/1995	CA	55.0	55		F	10/17/1995	pt recvd vax 11OCT95 & 13OCT sore throat;14OCT fever 101; gen aches-swollen glands, h/a & dec sore throat;15OCT non productive cough, laryngitis;16OCT-17OCT fatigue, cough-no fever										10/11/1995	10/13/1995	2	NONE	UNK	PVT	Premarin;Provera	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Cough; Headache; Laryngitis; Lymphadenopathy; Myalgia; Pharyngitis; Pyrexia	FLU3~PFIZER\WYETH~4958122~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078501	10/30/1995	NY	11.0	11		M	10/26/1995	5mins p/inj scattered mild erythema @ inj site, x 20mins;18OCT95 AM per mom, are red, PM red, raised softball size circular area;MD 3-4cm red, hot tender, indurated area to upper rt arm;prescribed ATB-cellulitis vs early sterile abscess,whe									Y	10/17/1995	10/17/1995	0	NONE	PVT	OTH	NONE	NONE	muscular dystrophy	~ ()~~~In patient		1						1	Abscess; Cellulitis; Injection site hypersensitivity; Injection site mass; Pain; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4958119~3~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078502	10/30/1995	NY	4.0	4		M	10/26/1995	@ 5mins post inj a pale, red rash noted @ inj site;MD prescribed DPH x 24hrs;19OCT95 arm is hard, red, warm to touch, size of palm of mom's hand;some redness below elbow;dx possible cellulitis;tx w/Lorabid, DPH									Y	10/17/1995	10/17/1995	0	NONE	PVT	OTH	NONE	NONE	NONE	pt exp local rxn @ 4yrs w/flu vax dose 1~ ()~~~In patient		1						1	Cellulitis; Injection site hypersensitivity; Injection site mass; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4958119~3~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078503	10/30/1995	PA	39.0	39		M	10/24/1995	redness, warmth, erythematous, sl tender 10x20cm area rt lateral arm; mostly distal to inj site									Y	10/17/1995	10/17/1995	0		PVT	PVT				~ ()~~~In patient		1						1	Pain; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4958082~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~PFIZER\WYETH~4958041~1~~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0078506	10/30/1995	WI	54.0	54		M	10/27/1995	chills, low grade temp, h/a, nausea, diarrhea									N	10/06/1995	10/26/1995	20	NONE	PVT	PVT				~ ()~~~In patient		1						1	Chills; Diarrhoea; Headache; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078512	10/30/1995	CA	75.0			M	10/19/1995	swelling of both hands as in remote hx of PCN rxn											10/09/1995			UNK	UNK			allergy to PCN;asthma	~ ()~~~In patient		1						1	Oedema peripheral; Oedema peripheral	FLU3~PARKE-DAVIS~00675P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLUX~UNKNOWN MANUFACTURER~00675P~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0078513	10/30/1995	WI	29.0	29		F	10/26/1995	got sick to stomach; got really lightheaded & dizzy, felt like that all day & noc;lt arm swollen up really bad & turned black & blue									Y	10/24/1995	10/24/1995	0		OTH	OTH		NONE		~ ()~~~In patient		1						1	Dizziness; Dyspepsia; Ecchymosis; Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078514	10/30/1995	PA	23.0			F		pt had flu vax in lt deltoid;reports that w/in hr devel a swelling, redness, soreness, & itch over site;											09/30/1995		NONE	UNK	UNK	BCP		NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Rash	FLU3~MEDEVA PHARMA, LTD.~5F61099~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0078924	10/30/1995	FL	62.0	62		F		a large 7 round shape around where vax given in lt arm; had flu shots a/w/no ill effect;called MD & spoke w/nurse				Y						10/09/1995	10/09/1995	0		PVT	PVT		lupus	lupus	~ ()~~~In patient		1						1	Injection site hypersensitivity	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0078393	10/31/1995	MI	48.0	48		F	10/24/1995	pt first noticed one tender, enlared lt midsupraclavicular lymph node one day p/vax;node was evaluated on 19OCT95 & was found to be slightly tender, mobile & approx 1-2cm in diameter;24OCT95 above node was no longer palpable				Y					Y	10/16/1995	10/17/1995	1	NONE	OTH	PVT	Sudafed/Seldane	hx of sinus problems	allergic to shellfish, nuts, dust, pollen & dog;prev dx bronchial asthma;hx sinus problems	~ ()~~~In patient		1						2	Lymphadenopathy; Pain; Lymphadenopathy; Pain	FLU3~PARKE-DAVIS~00885P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00885P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0078517	10/31/1995	IL	68.0	68		M	10/24/1995	severe wheezing & SOB hospitalized ER 9PM 17NOV95 had EKG, blood work, 02, lung tx, shot cortizone-heart monitor; kept overnoc for observation & monitered overnoc;MD determined rxn to flu shot				Y	Y	1			Y	10/17/1995	10/17/1995	0		PUB	UNK	DIlantin			~ ()~~~In patient	IL950118	1						1	Asthma; Dyspnoea	FLU3~CONNAUGHT LABORATORIES~5F61126~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0078518	10/31/1995	SD	79.0			F	10/27/1995	death (pt was found dead in the bathroom by husband, prev to this no complaints) no tx; no evaluation post mortem, data gather from conversation w/husband	Y								N		10/19/1995			OTH	PUB		IHSS, Bipolar disorder, Dementia	IHSS, Bipolar disorder, Dementia	~ ()~~~In patient		1						1	Myocardial infarction	FLU3~PFIZER\WYETH~4958112~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0078521	10/31/1995	MO	64.0	64		F	10/20/1995	pt stated recvd flu shot 17OCT95 @ 8AM on 18OCT95 about 10AM-1hr p/eating egg sandwich became lightheaded-lethargic-sweaty-disoriented;no local rxn									Y	10/17/1995	10/18/1995	1	NONE	PUB	PUB	Coumadin	NONE		pt exp rxn @ 63yrs w/Fluzone dose 1~ ()~~~In patient	MO95080	1						1	Confusional state; Dizziness; Hyperhidrosis; Somnolence	FLU3~CONNAUGHT LABORATORIES~5F61099~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078524	10/31/1995	NC	67.0	67		F	10/13/1995	13OCT call from pt reports entire rt arm is swollen extending down to elbow w/pain down to hand									Y	10/12/1995	10/12/1995	0	NONE	PUB	PVT	NONE	NONE	allergies to pollens, Niacin	NONE~ ()~~~In patient	NC95104	1						1	Oedema peripheral; Pain	FLU3~CONNAUGHT LABORATORIES~5F61165~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1076B~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0078528	10/31/1995	VT	78.0	78		F	10/25/1995	sudden onset fever, chill, coryza, nausea, scratching throat, coughing				Y						10/25/1995	10/25/1995	0		PUB	OTH	Gly burde, chlorthazidine, APAP	Otitis Media	HTN DM	~ ()~~~In patient		1						1	Chills; Cough; Nausea; Pharyngitis; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61127~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078529	10/31/1995	NY	57.0	57		F	10/30/1995	day of vax pt exp painful scratchy throat, severe cough, laryngitis, low grade fever 100.2-(nl for pt 97), severe cold-sneezing & running nose & chills;saw MD said pt had flu				Y					N	10/20/1995	10/21/1995	1	strep throat culture 21OCT95 neg; took EKG 24OCT95 nl	PUB	PUB	Premarin, Estrogen, Calcium, & vitamins	NONE	osteoarthritis; osteoporosis;chronic bronchitis	pt exp rxn w/ flu vax @ age 53 & 52;~ ()~~~In patient	NYS95070	1						1	Chills; Cough; Influenza; Laryngitis; Pharyngitis; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0078530	10/31/1995	MI	37.0	37		F	10/23/1995	pt recvd vax 13OCT95 & phoned clinic on 16OCT95 to report began breaking out in hives about 1 hr p/vax; took DPH which had @ home;14OCT95 reported to hosp ER w/hives all over;				Y					Y	10/13/1995	10/14/1995	1		PUB	PUB		NONE	NONE	~ ()~~~In patient		1						1	Urticaria	FLU3~PARKE-DAVIS~01495P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~390967~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0078531	10/31/1995	OH	17.0	17		F	10/27/1995	arm felt heavy & progressed to fever, leghargy, h/a, joint aches, & very weak lasted for 8 hrs on 7OCT95 from 1PM to approx 9PM;				Y					Y	10/06/1995	10/07/1995	1		PVT	PVT				~ ()~~~In patient		1						1	Arthralgia; Asthenia; Headache; Myasthenic syndrome; Pyrexia; Somnolence	FLU3~CONNAUGHT LABORATORIES~5F61127~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078538	10/31/1995	WI	38.0	38		F	10/20/1995	administered inj on 19OCT95 pt woke up on 20OCT95 c/o lt shoulder & lt sided neck pain (inj was in lt deltoid) couldn't move extremity w/o it hurting				Y					U	10/19/1995	10/20/1995	1	NONE	PVT	PVT	Azmacort, Claritin, Lasix, Ventolin, Tegretol, Beconase AQ, Lamcital, Multi-vit	NONE	allergic rhinitis-ashtma, sz disorder	NONE~ ()~~~In patient		1						1	Neck pain; Pain	FLU3~PFIZER\WYETH~4958138~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0078540	10/31/1995	WA	54.0	54		F	10/24/1995	pt recvd vax 11AM came back 5PM c/o episode of hemoptysis, shaking, chills, rapid breathing, t101.1, WBC 19.5 thousand; CXR neg; given APAP & Librium;given Restoril, Keflex;				Y					Y	10/19/1995	10/19/1995	0	CXR neg; WBC 19.5 ? lt shift	PVT	PVT	Asthmacort, Ventolin, Desyrel	COPD w/asthma/viral Hep B	allergic to PCN	NA~ ()~~~In patient		1						1	Chills; Haemoptysis; Hyperventilation; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61126~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078541	10/31/1995	CA	65.0	65		M	10/24/1995	weak, body aches, chills, fever, loss of appetite				Y					Y	10/12/1995	10/14/1995	2	CBC, UA, all WNL	PVT	PVT		NONE	hypertension, alcoholism, smoker	pt exp rxn @ 64yrs w/flu vax dose 1~ ()~~~In patient		1						1	Anorexia; Asthenia; Chills; Myalgia; Pyrexia	FLU3~PARKE-DAVIS~00475P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0078542	10/31/1995	MA	37.0	37		F	10/24/1995	pt became weak, diaphoretic, extremely pale, BP 102/60, 64-weak, hard to hear or palpate;c/o seeing spots;given Epi-BP 90/50-110/60 remained pale, & cont to see spots;taken to hosp				Y					Y	10/24/1995	10/24/1995	0	NONE	OTH	OTH	unk	NONE		~ ()~~~In patient		1						1	Asthenia; Hyperhidrosis; Hypotension; Pallor; Visual disturbance	FLU3~CONNAUGHT LABORATORIES~5F61143~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078544	10/31/1995	NC	68.0	68		M	10/20/1995	onset fever, myalgias, fatigue about 24hrs p/inj; loss of appetite, diarrhea;sxs abated some BP inc on BP meds, taking reg has taken no APAP; BP 200/98, T100.2-adv see PMD, APAP									Y	10/16/1995	10/17/1995	1		PUB	PVT	NA	NONE	HTN, glaucoma	~ ()~~~In patient		1						1	Anorexia; Asthenia; Diarrhoea; Hypertension; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61095~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078545	10/31/1995	MA	31.0	31		F	10/24/1995	local rxn-redness-swelling-itching;30min p/inj;DPH given per MD										10/24/1995	10/24/1995	0		PUB	PUB		NONE	asthma, Slophill, strawberries, fruit cocktail, tortinili salad	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~CONNAUGHT LABORATORIES~5F61134~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078546	10/31/1995	WA	45.0	45		F		pt exp flu vax  630PM started aches, queazy, no vomiting, fever, chills; did not call MD-ill in bed 24OCT;back to work 25OCT-still achey w/low grade fever									Y	10/23/1995	10/23/1995	0		PUB	PUB		NONE	NONE	pt exp achey w/flu vax in 1993~ ()~~~In patient	WA951179	1						1	Myalgia; Nausea; Pyrexia	FLU3~PFIZER\WYETH~4958139~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078547	10/31/1995	OR	47.0	47		M	10/23/1995	pt called in morning of 18OCT95 reporting onset of sore arm @ site devel evening of 17OCT95; w/down towards waist, to back of lt shoulder; general tenderness w/o swelling or redness x/ @ inj site;									Y	10/17/1995	10/17/1995	0	NA	PUB	PVT	NA	NONE	codeine only	~ ()~~~In patient		1						1	Injection site pain; Pain	FLU3~PFIZER\WYETH~4958112~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078548	10/31/1995	NJ	67.0	67		F	10/26/1995	pt's rt arm red circle 2-3 diameter w/severe inflammation									Y	10/23/1995	10/24/1995	1	NONE	PUB	PUB	Synthroid	NONE		~ ()~~~In patient	NJ9547	1						1	Injection site inflammation; Vasodilatation	FLU3~PARKE-DAVIS~01495P~4~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~390934~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0078549	10/31/1995	MO	27.0	27		M	10/20/1995	itching & redness onlt upper arm & lt palm; given Epi									Y	10/18/1995	10/18/1995	0		PUB	PVT		NA	blind	NA~ ()~~~In patient		1						1	Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5J61007~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078556	10/31/1995	OH	71.0	71		F	10/27/1995	had a sl sore throat 18 & 19OCT p/vax devel cold w/cough & sinus infect like never a/;pt thinks should be asked not only if they have a fever but also if they might be coming down w/something a/vax									Y	10/19/1995	10/19/1995	0		PVT	OTH	Thyrolar	sl sore throat-no fever	ragweed & grass & milk allergies	~ ()~~~In patient		1						1	Cough; Infection; Pharyngitis; Rhinitis; Sinusitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078557	10/31/1995	CT	43.0	43		M	10/24/1995	pt exp tightness airway & mild difficulty breathing;took DPH twice that evening;was told snored all noc (i.e. obstructed airway); sxs dissipated p/20 hrs									Y	10/13/1995	10/13/1995	0	NONE	OTH	PUB	Seldane, Advil	NONE	hayfever	NONE~ ()~~~In patient		1						1	Dyspnoea; Laryngospasm	FLU3~CONNAUGHT LABORATORIES~5F61134~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078558	10/31/1995	WI	61.0	60		M	10/25/1995	8cm localized reddened area									U	10/23/1995	10/24/1995	1		PVT	PVT		NONE	T-cell lymphoma	~ ()~~~In patient		1						1	Vasodilatation	FLU3~PFIZER\WYETH~4958118~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078560	10/31/1995	IL	31.0	31		M	10/25/1995	pt recvd vax OCT94 & later devel sxs of eustachian tube dysfunction-co-workers had same problem w/their flu shots; sxs returned p/flu shot OCT95									Y	10/01/1994	10/01/1994	0	nl audiogram, tympanogram FEB95	OTH	PVT	NONE	NONE	flew on plane (but p/sxs began)	~ ()~~~In patient		1						1	Ear disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078561	10/31/1995	KS	48.0			F	10/16/1995	2 sl raised reddened area; warm to touch burise 2 x 4 w/some swelling;									Y		10/16/1995		NA	PUB	UNK		NONE	hypertensive; exertional asthma	~ ()~~~In patient		1						1	Ecchymosis; Oedema; Urticaria; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0084006	10/31/1995	MI	62.0	62		M	10/09/1995	pt recvd vax 4OCT95 & c/o ringing in lt ear;denies c/o trauma, swimming & pain				Y					U	10/04/1995	10/05/1995	1	exam w/ENT	PUB	OTH		NONE	DM, HTN, PMR	NONE~ ()~~~In patient	MI95134	1						2	Deafness; Tinnitus	FLU3~PFIZER\WYETH~4958111~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0078572	11/01/1995	TX	57.0	57		F	10/25/1995	hot, red, swollen lt arm				Y						10/24/1995	10/24/1995	0	NONE	PUB	OTH	Cycrin, Zesterectic, Estrace	NONE	hypertension/climateric	~ ()~~~In patient		1						1	Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F51145~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078573	11/01/1995	FL	27.0			F	10/25/1995	pt became dizzy, fell to ground; disoriented-recovered w/in 10mins;hx of fainting; signs & sxs of a vasovagal reflex syncope				Y					Y	10/24/1995	10/24/1995	0		PVT	UNK	Claritin, oral contraceptives	NONE	NONE	~ ()~~~In patient		1						1	Confusional state; Dizziness; Syncope	FLU3~CONNAUGHT LABORATORIES~5F61166~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078576	11/01/1995	NY	30.0	30		F	10/16/1995	had pin in the arm, where got the shot neck to elbow;happened about 2 hrs p/shot;									Y	10/13/1995	10/13/1995	0		PUB	UNK		NONE	NONE	~ ()~~~In patient	NYS95071	1						1	Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078580	11/01/1995	MO	47.0	47		F	10/27/1995	pt recvd vax 4OCT95 & believed the inj was given too high; exp immediate arm pain which cont to persist; pt encouraged to consult MD									U	10/04/1995	10/04/1995	0	NA	OTH	PVT	NONE	NONE	NONE	unk~ ()~~~In patient		1						1	Pain	FLU3~PFIZER\WYETH~4958124~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078589	11/02/1995	FL	45.0	44		M	10/16/1995	c/o nasal congestion & body aches 8-10 hrs sp/ inj;sxs lasted 24-48hrs;denied having fever @ any time									Y	10/11/1995	10/12/1995	1		OTH	PUB	NA	had c/o prodionol sxs	NA	~ ()~~~In patient	FL95068	1						1	Myalgia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61127~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078590	11/02/1995	FL	72.0	72		F	10/18/1995	pt has been ill w/T99-102, h/a, chills, fever, pain in leg & back for past 2wks since shot;has seen MD 3x & MD sending pt to infect disease MD 19OCT95;				Y					N	10/04/1995	10/05/1995	1	blood culture pending	PUB	PUB	Prolisor	denies	medication for stomach	NA~ ()~~~In patient	FL95069	1						1	Back pain; Chills; Headache; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61150~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078591	11/02/1995	FL	37.0	37		F	10/06/1995	throat, tongue, palate numb, chest neck red color;DPH give w/relief; P78 R16 BP 135/90 lying flat;states fingers tingling 12:15 neck & ears burning 12:30 upright 132/80 76-18, advised to see allergist									U	10/04/1995	10/04/1995	0	NONE	PUB	PUB	NA	NONE	PCN	NA~ ()~~~In patient	FL95071	1						1	Hypoaesthesia; Pain; Paraesthesia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61150~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078593	11/02/1995	FL	64.0	64		F	10/18/1995	pt recvd vax 830AM @ 2PM started to itch all over especially eyes;no rash or redness; called MD & started on Pred				Y					Y	10/16/1995	10/16/1995	0	NA	PUB	PUB	NONE	NONE	sulfa	~ ()~~~In patient	FL95073	1						1	Pruritus	FLU3~CONNAUGHT LABORATORIES~5F61149~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078594	11/02/1995	FL	65.0	65		F	10/09/1995	12-14 hrs p/vax devel chills, t103, fever, aches, severe h/a & red-macular papular rash over rt arm, face as progressed to chest, waist & back-lasted 2 days;tx w/DPH & methyl Pred decreasing dosage per pvt MD orders;									Y	10/03/1995	10/03/1995	0	NA	PUB	PUB	NONE	NONE	several ATB	~ ()~~~In patient	FL95074	1						1	Chills; Headache; Myalgia; Pyrexia; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~5F61134~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078597	11/02/1995	MS	65.0	65		F	10/26/1995	pt recvd vax & felt somewhat lethargic for rest of day;no erythema; edema lt arm, but c/o dull aches x's 7wk, which has inc in intensity over 2nd wk;ROM good, but painful;taken med for pain									U	10/11/1995	10/11/1995	0	NA	PUB	PUB	Premarin	NONE	environmental allergies	NA~ ()~~~In patient	MS95047	1						1	Pain; Somnolence	FLU3~PARKE-DAVIS~01395P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0078599	11/02/1995	NH	64.0	64		M	10/27/1995	lt arm soreness & redness elbow level-some swelling;no rxn rt @ site of inj 5/8 needle used;				Y					U	10/26/1995	10/26/1995	0		PVT	PVT	Provental, Tagamet, Atrovent, Asmthecourt	Emphysema, Stomach prob		~ ()~~~In patient	NH95025	1						1	Myalgia; Vasodilatation	FLU3~PFIZER\WYETH~4958116~3~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0078601	11/02/1995	NY	31.0	31		M	10/25/1995	pt recvd vax 19OCT95 11PM & had a sz;pt holding rt arm where vax given; took gasps of breath & got tremors, frothed @ mouth & eyes rolled back in head;pain; gasped loudly several times & may have stopped breathing; sz				Y					Y	10/19/1995	10/19/1995	0	20OCT95 CAT Scan brain MD reported OK CXR=nl; bloodwork was nl;urine test nl;EKG nl;	PUB	PUB	Mellaril, DPH	no illness, allergy sx red eyes, stuffy	neurological problem d/t birth defect, seasonal allergies	NONE~ ()~~~In patient	NYS95060	1						1	Apnoea; Convulsion; Dyspnoea; Gaze palsy; Salivary hypersecretion; Tremor	FLU3~PARKE-DAVIS~01595P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0078602	11/02/1995	CA	63.0	63		F		pt devel high fever, cough, chest congestion soon p/vax;temp to 104 onset 24hrs p/vax;sxs cont, now 10 days post vax fever, cough				Y					N	10/19/1995	10/20/1995	1	12/36/6,800,77P, 0B, 12L, 6M, 4E,1B,Sa02 99% on RA, CBC, CXR-possible lt LL infilt	PUB	UNK	NONE	NONE	had renal cancer & nephrectomy 3 years prior, no demo	~ ()~~~In patient	CA95139	1						1	Cough; Lung disorder; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0078603	11/02/1995	WI	75.0	75		F	10/30/1995	pt recvd vax 19OCT95 & later afternoon very tired, aching-both arms-more so-left;ice-pack & APAP 20OCT95 AM lt arm 1:30AM area @ swelling was approx 8cm x 8cm -cont swelling & red-Hismanal				Y					Y	10/19/1995	10/19/1995	0		PVT	UNK		HTN, rheumatoid, mitral valve	ASA, Plaguenal, Ridura, Sulpha, Sjorgens synd, pneu APR95	~ ()~~~In patient		1						1	Asthenia; Oedema peripheral; Pain; Pyrexia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0078604	11/02/1995	NY	69.0	69		F	10/30/1995	fever 102.6;aching body, cough, weakness, pneumonia; Biaxin x 10 days-still on				Y					Y	10/13/1995	10/17/1995	4	CXR	PUB	OTH	HCTZ	NONE	mild HTN	~ ()~~~In patient		1						1	Asthenia; Cough; Myalgia; Pneumonia; Pyrexia	FLU3~PARKE-DAVIS~~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0078605	11/02/1995	TX	33.0	33		F	10/27/1995	arm swollen, red, hard, temp, dizzy, nauseated, diarrhea;saw nurse @ health center;also saw pvt MD				Y					Y	10/25/1995	10/25/1995	0	NONE	OTH	OTH	Zoloft, Sythroid, Biaxin	NONE	shell-fish allergy	NONE~ ()~~~In patient		1						1	Diarrhoea; Dizziness; Nausea; Oedema peripheral; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61163~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078606	11/02/1995	WA	55.0	55		F	10/20/1995	states that p/vax had bruised area, swollen to base of neck, had huge knot & base of neck in a direct line from inj site;pt called stated swelling & soreness mostly gone;had some diff raising arm;									Y	10/13/1995	10/13/1995	0		PUB	PUB	Day pro	sinus problem	allergic to codiene; hx of CA hypterestomy in CA; sinus problems;neck/back injury in time 95-no tx for last month	NA~ ()~~~In patient	WA951181	1						1	Ecchymosis; Hypokinesia; Oedema peripheral; Pain; Skin nodule	FLU3~PFIZER\WYETH~4958126~5~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078607	11/02/1995	WA	39.0	39		M	10/26/1995	pt recvd vax 25OCT95 & started to feel uncomfortable about 2hrs p/shots;arm was sore (lt arm swollen from middle to elbow, reddened, warm to touch) yesterday had fever, aches;took APAP; had no relief;										10/25/1995	10/25/1995	0	NA	PUB	PUB	Vancenase nasal spray	sinus infection	only sinusitis	NA~ ()~~~In patient	WA951180	1						1	Myalgia; Oedema peripheral; Pain; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4981126~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~SMITHKLINE BEECHAM~19028A2~UNK~~RA~HEP B (ENGERIX-B)~1|PPV~PFIZER\WYETH~384957~UNK~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0078608	11/02/1995	KS	23.0	22		F	10/25/1995	lt deltoid 6 x 4 reddened circle, hot & painful to touch;mild flu-like sxs, low-grade temp, fatigue & h/a									Y	10/19/1995	10/20/1995	1	NA	PUB	PVT	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Asthenia; Headache; Influenza; Injection site hypersensitivity; Injection site pain; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4958111~6~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078609	11/02/1995	MT	52.0	52		F	10/30/1995	arm swoll up all around inj site; turned bright red w/a white ring around it;swelling lasted 3 days;site itched but burned when itched;On day 4 site changed from a red color to a rust color;itching cont for more days;had a bad h/a;									Y	10/20/1995	10/20/1995	0		PVT	PVT	Premarin, Intal, Azmacort, Atrovent	NONE	asthma, allergic to PCN & sulfa	~ ()~~~In patient		1						1	Headache; Injection site hypersensitivity; Injection site oedema; Pain; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078611	11/02/1995	VA	77.0	77		F	10/24/1995	approx 5-10mins p/vax pt reported feeling drunk light headed & severe localized itching to lt arm-denies any throat tightness;lung sounds clear to auscultation;VS s/s of event 128/78 100 24 97.8 # 1510 150/88 84 20									Y	10/24/1995	10/24/1995	0	irregular heart beat, HTN	OTH	PVT	unk	none	PCN;ASA;x-ray dye; sulfa	NA~ ()~~~In patient		1						1	Dizziness; Pruritus	FLU3~CONNAUGHT LABORATORIES~5F61168~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078612	11/02/1995	WV	49.0	49		F	10/30/1995	approx 5mins p/vax pt felt heat @ site radiating into shoulder;skin in area blotchy-not hot to touch; DPH given-ice to site;									Y	10/30/1995	10/30/1995	0	NA	PVT	PVT	Vasotec; ASA; Primatine	NONE	elevated BP	NONE~ ()~~~In patient		1						1	Vasodilatation	FLU3~PFIZER\WYETH~4958109~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078614	11/02/1995	CO	64.0	64		F	10/27/1995	pt reports being highly agitated p/vax; wound up for 2 days									Y	10/18/1995	10/18/1995	0		PVT	PVT	Accupril, Cardizem, Lasix, Glynase		diabetes mellitus, CHF, HTN, polcythema	~ ()~~~In patient		1						1	Agitation	FLU3~CONNAUGHT LABORATORIES~5F61096~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078615	11/02/1995	NY	42.0	42		F	10/26/1995	32x45mm area @ inj site; erythema, warmth, & edema									U	10/24/1995	10/24/1995	0		PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4958082~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078616	11/02/1995	NY	50.0	50		F	10/26/1995	4x6cm area @ site erythema, warmth									U	10/24/1995	10/24/1995	0		PVT	OTH	Accupril, Esidrix, Procardia, KCL, Clonidine	NONE		~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PFIZER\WYETH~4958082~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078617	11/02/1995	WY	42.0	42		F	10/25/1995	pt recvd vax 23OCT95 & 24OCT95 noticed a bruise size 1 1/2 x 2, tender to touch;25OCT95 AM soreness inc to shoulder; warm to touch									Y	10/23/1995	10/24/1995	1		OTH	PUB		NONE	NONE	NONE~ ()~~~In patient		1						1	Ecchymosis; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4958117~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078620	11/02/1995	NJ	44.0	43		F	10/30/1995	upper lt arm became inflammed & edematous immed p/vax; arm was extremely tender to touch;arm was iced intermittently throughout the day;pt's pvt physician was notified									Y	10/27/1995	10/27/1995	0	NONE	OTH	PUB	Norpace;Kerlone	NONE	atrial fibrillation, mitral valve prolapse	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pain	FLU3~CONNAUGHT LABORATORIES~5F61133~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078621	11/02/1995	IL	71.0	70		M	10/30/1995	chills, fever & aching all over body especially in the legs;also confused when getting up during the noc unable to find bathroom									Y	10/25/1995	10/26/1995	1		PVT	PVT	Mevacor; accupril; ASA	NONE	hyperlipidemia	pt exp similar s/s @ 20 w/flu~ ()~~~In patient		1						1	Chills; Confusional state; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61116~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~390968~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0078623	11/02/1995	PA	63.0	63		F	10/28/1995	S: pt c/o rash & itching on forearms approx 20'; O: hives observed on forearms; A: Epi given; P: observed pt SOB, or futher swelling noted									Y	10/28/1995	10/28/1995	0		OTH	OTH	Prinival; Ativan	NONE	NKA	~ ()~~~In patient		1						1	Pruritus; Rash; Urticaria	FLU3~MEDEVA PHARMA, LTD.~2765HB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0078512	11/03/1995	CA	75.0			M	10/09/1995	swelling of both hands as in remote hx of PCN rxn											10/09/1995			UNK	UNK			asthma; allergy to PCN	~ ()~~~In patient		1						2	Oedema peripheral; Oedema peripheral	FLU3~PARKE-DAVIS~00675P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLUX~UNKNOWN MANUFACTURER~00675P~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0078631	11/03/1995	TX	68.0	68		F	10/25/1995	devel swollen trachea-almost closed off; adm to ICU & rx w/steroids & antihistamines;discharged 20OCT  @ 8AM 23OCT 4AM hives;				Y	Y	2				10/18/1995	10/18/1995	0		OTH	OTH	HBP	NONE	HBP	pt exp rxn w/Td @ age 65~ ()~~~In patient		1						1	Laryngeal oedema; Urticaria; Dyspnoea; Hypersensitivity; Laryngeal oedema; Urticaria	FLU3~CONNAUGHT LABORATORIES~5F61166~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~5F61166~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0078632	11/03/1995	OH	79.0	79		F	10/15/1995	nausea & vomiting-aspirated pneumonia adm to hosp; lt arm very swollen, red & sore; dx cellulitis adm 16OCT95					Y				U	10/15/1995	10/15/1995	0		OTH	PVT	Zantac, Amiytriptyline		alzheimer, s/p CVA	NONE~ ()~~~In patient		1						1	Cellulitis; Infection; Myalgia; Nausea; Oedema peripheral; Respiratory disorder; Vasodilatation; Vomiting; Cellulitis; Nausea; Oedema peripheral; Pain; Pneumonia; Vasodilatation; Vomiting; Cellulitis; Nausea; Oedema peripheral; Pain; Pneumonia; Vomiting	FLU3~CONNAUGHT LABORATORIES~5F61166~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~107613~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~CONNAUGHT LABORATORIES~5F61166~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~107613~UNK~IM~LA~PNEUMO (PNEUMOVAX)~2|FLU3~CONNAUGHT LABORATORIES~5F61166~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~1076B~UNK~IM~~PNEUMO (PNEUMOVAX)~3	USA	Hospitalisation	Influenza
0078633	11/03/1995	FL	80.0	80		F	10/24/1995	devel pleurisy 24hrs p/vax;hospitalized for 7-10d rx ATB					Y	10			Y	09/28/1995	09/29/1995	1		UNK	UNK		NONE		NONE~ ()~~~In patient		1						1	Pleural disorder; Pleural disorder	FLU3~CONNAUGHT LABORATORIES~5F61135~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~5F61135~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0078635	11/03/1995	AZ				F	10/25/1995	pt recvd flu vax several yrs noticed major flare-up of rheumatoid arthritis following yearly flu shot; in 1995 exp flare-up both shoulders cont up the present;														UNK	UNK	Methotrexate; Tenoprofen; pred; Folic acid		rheumatoid arthritis since 1989; alcohol-very little	~ ()~~~In patient		1						1	Condition aggravated; Rheumatoid arthritis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078636	11/03/1995	CO	54.0	54		F	10/24/1995	30mins p/vax devel burning ears, tingling tongue, swollen eyes, 4 hrs p/vax devel cough rx antihistamine				Y					Y	10/07/1995	10/07/1995	0		UNK	UNK	NONE	NONE	allergic: demerol, chemicals, foods, pollens	NONE~ ()~~~In patient		1						1	Cough; Ear disorder; Face oedema; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078638	11/03/1995	TN	66.0	66		F	09/25/1995	skin became flushed, warm & dry, dizziness, BP 160/80, resp became labored 24/min & inc 30/min;fainted; Epi given;BP 180/110;P60, R36 shallow resp 2nd dose Epi given;irratic breathing				Y						09/25/1995	09/25/1995	0		OTH	OTH	Synthroid, Premarin	NONE	NONE	NONE~ ()~~~In patient		1						1	Dizziness; Dry skin; Dyspnoea; Hypertension; Hyperventilation; Syncope; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61166~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078639	11/03/1995	WA	33.0	32		F	09/26/1995	rash & chest tightness, diarrhea & h/a;given DPH				Y					Y	09/25/1995	09/26/1995	1		OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Chest pain; Diarrhoea; Headache; Rash; Chest pain; Diarrhoea; Headache; Rash	FLU3~CONNAUGHT LABORATORIES~5G1166~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~5H71142~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0078640	11/03/1995	PA	28.0	28		F	11/02/1995	lt side of face became numb- & hot; dec in sensation for over 1wk;				Y					U	10/23/1995	10/23/1995	0	CBC WNL; ANA neg; Sed WNL	OTH	PVT	pt recvd Recombivax by MSD	NONE	NONE	~ ()~~~In patient		1						1	Hypoaesthesia; Paraesthesia; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0078641	11/03/1995	SC	48.0	48		F	11/02/1995	sweating, light headedness, hives, head & neck pain, diarrhea;				Y					N	11/01/1995	11/01/1995	0	NONE	PVT	PVT	Premarin	NONE	inscent, stress related hypertension	~ ()~~~In patient		1						1	Diarrhoea; Dizziness; Headache; Hyperhidrosis; Neck pain; Urticaria	FLU3~PFIZER\WYETH~4958069~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0078642	11/03/1995	NY	48.0	48		F	10/31/1995	19OCT 3PM pt recvd vax 10mins later sneezing, runny nose, congestion develops; 20OCT low grade temp, flu like s/s, gen malaise lt work early;21-22OCT gen malaise cont;23OCT axilla lt pain, swelling, hard area;lt arm spasm 24OCT95				Y						10/19/1995			breast u/s & mammogram;	PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Hypertonia; Influenza; Lymphadenopathy; Malaise; Pain; Pharyngitis; Pyrexia; Rhinitis	FLU3~PFIZER\WYETH~4958138~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0078643	11/03/1995	FL	15.0	15		F	10/26/1995	3-4d p/vax devel h/a assoc w/twitching of rt eye, followed by tingling parasthesia of rt arm;also had mild exacerb of asthma;									Y	10/17/1995	10/20/1995	3	NONE	PVT	PVT	Azmacort,Intal, Ventolin, Vancenase	NONE	asthma (reactive airway disease); allergic rhinitis; Migraine	pt exp same sxs in 1994 @ 14yrs w/flu vax~ ()~~~In patient		1						1	Asthma; Condition aggravated; Headache; Muscle twitching; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~5F61012~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078645	11/03/1995	WA	23.0	23		F	10/18/1995	immed dizziness, hyperventilating, chest tightness, diff breathing, anxiety; Epi given refused further treatment-left ambulatory				Y					Y	10/11/1995	10/11/1995	0		OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Anxiety; Chest pain; Dizziness; Dyspnoea; Hyperventilation	FLU3~CONNAUGHT LABORATORIES~5F61144~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078646	11/03/1995	TX	43.0	43		F	10/17/1995	c/o parathesia in deltoid area & shoulder/back area;feels like pains & needles									U	10/15/1995	10/16/1995	1		OTH	OTH	NONE	NONE	asthma; cluster h/a	NONE~ ()~~~In patient		1						1	Paraesthesia	FLU3~CONNAUGHT LABORATORIES~5F61166~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078647	11/03/1995	FL	59.0	59		F	10/23/1995	24hrs p/vax devel rash both arms, chest, neck, stomach-no swelling rash is itchy;rx DPH									U	10/19/1995	10/20/1995	1		OTH	OTH	Premarin	NONE	NONE	NONE~ ()~~~In patient		1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~5F61135~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078648	11/03/1995	SC	44.0	44		F	10/16/1995	itching all over, warm all over took DPH									U	10/11/1995	10/11/1995	0	NONE	OTH	OTH	Dilantin, Amytripila, Cloridine		szs-rt side brain damage	NONE~ ()~~~In patient		1						1	Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61143~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1076B~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0078649	11/03/1995	OK	61.0	61		F	10/21/1995	pt recvd vax 17OCT95 & on 20OCT95 noted rt arm was bruised & devel welts on back & neck all on rt side;believes the welts are secondary to pneumovac's; has had flu shot tiwce a/ w/o problem										10/17/1995	10/20/1995	3		OTH	PVT	Zantac, Thyroid, Premarin, Zocor	NONE	elevated Cholesterol, Thyroid Problem	~ ()~~~In patient		1						1	Ecchymosis; Urticaria	FLU3~CONNAUGHT LABORATORIES~5F61144~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1076B~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0078650	11/03/1995	MI	29.0	29		F	10/29/1995	pt recvd vax & in 10mins became clammy, cool skin & blurred vision-BP 132/72, P92, given Epi BP 128/82, P82									Y	09/25/1995	09/25/1995	0		OTH	OTH				NONE~ ()~~~In patient		1						1	Amblyopia; Chills; Hyperhidrosis; Hyperventilation	FLU3~CONNAUGHT LABORATORIES~5F61144~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078652	11/03/1995	MA	66.0	66		F	11/01/1995	chills, malaise, flu like sxs, cough, nausea feeling, frequent urination									N	10/27/1995	10/29/1995	2	NONE	OTH	OTH	Vicodin, Diozide sulfasalasine, Flexiril, Ativan	NONE	chronic back pain, CCrohns Disease	~ ()~~~In patient		1						1	Chills; Cough; Influenza; Malaise; Nausea; Pollakiuria	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078654	11/03/1995	CA	40.0	40		F	10/25/1995	pt devel hives p/1st flu vax;										10/13/1995	10/13/1995	0		UNK	UNK				~ ()~~~In patient		1						1	Urticaria	FLU3~PARKE-DAVIS~0057P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0078657	11/03/1995	MS	70.0	70		F	10/30/1995	30OCT95 pt called stated had adverse rxn to shot lt arm sore x's 2 days then became edematous & erythemic 3 days later; consulted family MD on 26OCT95 who prescribed DPH									Y	10/30/1995	10/30/1995	0		PUB	PUB	Hormones, Vitamins	NONE	NONE	NA~ ()~~~In patient	MS95050	1						1	Myalgia; Oedema peripheral; Rash	FLU3~PARKE-DAVIS~1395P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~CONNAUGHT LABORATORIES~5F71086~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0078658	11/03/1995	MO	68.0	68		F	10/24/1995	pt recvd vax 1300hrs @ 1600 hrs exp nausea, weakness when turning head to the left feel like going to pass out & get nauseated, occasional ringing in the ears;slept on rt side had exp some improvement this am but problem w/head turning cont										10/23/1995	10/23/1995	0		PUB	PUB				~ ()~~~In patient	MO95081	1						1	Asthenia; Nausea; Neck pain; Tinnitus; Asthenia; Nausea; Syncope; Tinnitus	FLU3~CONNAUGHT LABORATORIES~5F6119~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~5F61119~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0078660	11/03/1995	NJ	67.0	67		F	10/25/1995	20OCT95 flu vax given;23OCT95 rash appeared on obth arms from shoulder to wrist									U	10/20/1995	10/23/1995	3		PUB	PUB		NONE	NONE	~ ()~~~In patient	NJ9546	1						1	Rash	FLU3~CONNAUGHT LABORATORIES~5F61023~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078678	11/06/1995	MS	67.0	66		M	10/26/1995	rash sx urticaria-severe itch;tx DPH, po & dermatox lotion starch & soda baths-next day went back to MD for DPH-used clorox @ home to clear up rash;				Y					Y	10/19/1995	10/19/1995	0		PUB	PUB	Prophylactic	bad lungs, ?CA	bad lungs, ?CA	~ ()~~~In patient	MS95051	1						1	Pruritus; Rash; Urticaria	FLU3~PARKE-DAVIS~001185P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0078679	11/06/1995	MS	82.0	82		F	10/30/1995	had severe dizzy from 7AM-11AM on 28OCT95 w/nausea; had to go outside to get fresh air to breath;stayed outside 15-20mins then went inside & sat around; gradually got better;was unable to lay down d/t to swimming effect;									Y	10/25/1995	10/28/1995	3	NONE	PUB	PUB	Chomagtris, Synthroid	arthritis, thyroid prob	ASA, Codeine, Tetanus, PCN	~ ()~~~In patient	MS95049	1						1	Dizziness; Nausea	FLU3~PARKE-DAVIS~01285P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0078684	11/06/1995	MA	43.0	43		F	10/20/1995	rt deltoid area is swollen 2/3 of arm, tender, red, hot, indurated; pt was seen in ER 18OCT95 f/u in 2 days				Y					U	10/18/1995	10/18/1995	0		PUB	PUB	Biaxin, Beconase, MDI, albuterol MDI	asthma	PCN	~ ()~~~In patient		1						1	Oedema peripheral; Pain; Skin nodule; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61134~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~1434A~1~~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0078686	11/06/1995	WY	35.0	35		F	10/31/1995	stiffness from shoulder to hand;soreness & tight in shoulder, elbow, wrist;redness/hot @ site;very tender in axillary lymph area;treated w/ASA				Y					Y	10/27/1995	10/28/1995	1	NONE	PUB	PUB	Cozarr;Orthocycline	NONE	allergit to codeine,Adalatic	NONE~ ()~~~In patient	WY9521	1						1	Arthralgia; Hypertonia; Injection site hypersensitivity; Myalgia; Pain	FLU3~PFIZER\WYETH~4958112~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0078687	11/06/1995	MA	78.0	78		F	10/31/1995	pt describes painful rt arm 24hrs p/vax;By 5th day area became red, edematous, & devel into infect according to pt;was seen on ER 24OCT95 where cyst was aspirated;pt was placed on 7 days therapy of Cephalexin; cellulitis				Y					Y	10/19/1995	10/21/1995	2		PUB	PUB	Zantac, Metrobonate;pt recvd Pneumovax by Lederle lot# 394962	NONE	arthritis	~ ()~~~In patient		1						1	Cellulitis; Cyst; Infection; Oedema peripheral; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61134~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078690	11/06/1995	NY	56.0	56		M	10/31/1995	severe shaking, unable to walk because of shaking				Y					Y	10/18/1995	10/18/1995	0		OTH	PVT	Zestril, Procardia, Glyburide	NONE	Diabetes, HTN	NONE~ ()~~~In patient		1						1	Hypotonia; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0078691	11/06/1995	NC	38.0	38		F	11/01/1995	pt states area where vax given was itching severely;stated itching since inj given but reported 10-15mins p/vax;c/o light-headedness, abn resp & feeling a littel warm; c/o difficulty breathing transported to ER				Y					Y	10/25/1995	10/25/1995	0		PUB	PVT				~ ()~~~In patient		1						1	Dizziness; Dyspnoea; Pruritus; Respiratory disorder; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61167~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078693	11/06/1995	TX	59.0	59		F	10/28/1995	pt recvd vax 22OCT95 & 24OCT95 became congested, had chills, h/a, 3 red strip on arm from flu shot, sore;25OCT went to clinic they took blood, had very high allergy count;pt given allergy shot & Keflex;also aching all over				Y					N	10/22/1995	10/24/1995	2	high allergy to something;	PVT	UNK		NONE	NONE	~ ()~~~In patient		1						1	Chills; Headache; Injection site hypersensitivity; Injection site pain; Myalgia; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0078700	11/06/1995	NC	22.0	22		F	10/30/1995	onset of body aches w/1 daily episode of diarrhea x 5 days; took Kaopecktate 28OCT95 stools now more formed; fluids & APAP									N	10/24/1995	10/25/1995	1		OTH	PVT	pt recvd Engerix & PPD by Smithkline & Connaught lot# 1740A4 & 2403111 on 19SEP95	NONE	NONE	~ ()~~~In patient		1						1	Diarrhoea; Myalgia	FLU3~PFIZER\WYETH~4958073~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078701	11/06/1995	MD	55.0	54		F	10/27/1995	48hrs later pt w/6cm erthema & induration @ site of inj									Y	10/25/1995	10/27/1995	2	NA	PVT	PVT	Zestril, Zantac	NONE	NKDA- h/o diverticulosis, GERO	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4958126~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078704	11/06/1995	KS	58.0	58		F	10/27/1995	c/o burning feeling in lt arm which pt states started 2 or 3 days p/inj to lt arm;reported on 27OCT95									U	10/12/1995	10/14/1995	2	NA	OTH	PVT	unk	unk	unk	unk~ ()~~~In patient		1						1	Pain	FLU3~PFIZER\WYETH~4958124~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078706	11/06/1995	OH	34.0	34		F	11/01/1995	3hrs p/vax pt stated that began w/coughing, sl diff breathing & then several hrs p/vax;low grade fever;took APAP did not call PMD: called on ofc next morning 31OCT95;									Y	10/30/1995	10/30/1995	0	NONE	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Cough; Dyspnoea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61167~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078708	11/06/1995	IL	67.0	67		F	10/27/1995	rt upper arm started to swell & ache w/in 2-4 hrs;kept pt awake w/pain next day inflammed, indurated & warmth-tender above elbow to shoulder;poss herpes simple									N	10/26/1995	10/26/1995	0	NONE	PVT	PVT	Insulin-Prilosec; Ultram-Sineguan, Procardia	NONE	pancrealitis, diabetis insulin dep	NONE~ ()~~~In patient		1						1	Herpes simplex; Myalgia; Oedema peripheral; Pain; Skin nodule; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~428501~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0078710	11/06/1995	WA	43.0	43		F	10/30/1995	local soreness that day-woke up the following day w/tender lymph nodes under lt arm-no nodule noted;took advil-cont to be lt underarm soreness									U	10/24/1995	10/25/1995	1		PUB	PVT	NA	NA	NA	~ ()~~~In patient		1						1	Injection site pain; Pain	FLU3~PFIZER\WYETH~4958139~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078711	11/06/1995	WA	32.0	32		F	10/30/1995	20-30mins p/vax localized burning feeling, warm to touch-shooting pain @ site like a beesting when touched or rubbed-shooting pain started again;took 2 aleve tablets-applied ice to arm @ 5PM; still warm & shooting pain-less severe but const									U	10/27/1995	10/27/1995	0		PUB	PVT	NA	NA	Demeral, codeine, stadol, phenergan, nuprine, visteral, keflex	~ ()~~~In patient		1						1	Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4958139~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078712	11/06/1995	MO	29.0	29		F	11/01/1995	rash, light, pink, raised, itching, about 5-6cm around site; resolved									Y	10/26/1995	10/27/1995	1	NA	PUB	PVT		NONE	NA	NONE~ ()~~~In patient		1						1	Injection site reaction; Pruritus; Rash maculo-papular	FLU3~PFIZER\WYETH~4958081~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078713	11/06/1995	OH	54.0	54		F	11/01/1995	pt recvd flu vax & w/in 25mins pt c/o itching of lips & nose;immed p/itching pt began vomiting x 15mins;10 mins p/vomiting the pts face became very flushed & entire body broke out in a red non raised rash;pt recvd DPH & sxs subsided;									Y	10/20/1995	10/20/1995	0	Ovarian cancer	PVT	PVT	Caboplatin, Cytoxan	ovarian cancer	ovarian cancer	NONE~ ()~~~In patient		1						1	Pruritus; Rash; Vasodilatation; Vomiting	FLU3~CONNAUGHT LABORATORIES~5F61114~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078765	11/06/1995	MN	68.0	68		F	10/31/1995	pt recvd vax 530PM, same day, severe vomiting, chills, fever;lasted thru the noc; was OK the next day;									Y	10/18/1995	10/18/1995	0		UNK	UNK		NONE	NONE	pt also got ill last year but not as severely on the same day as the shot recvd~ ()~~~In patient		1						1	Chills; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079751	11/06/1995	OH	59.0	59		F	10/25/1995	20OCT95 c/o rash all over body, resp easy, in ER had started IV & given Solumedrol, DPH given & Zantac				Y					Y	10/14/1995	10/20/1995	6	NONE	PUB	UNK		NONE	IVP dye	~ ()~~~In patient	OH95152	1						1	Rash	FLUX~UNKNOWN MANUFACTURER~4958137~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0078658	11/07/1995	MO	68.0	68		F	10/24/1995	pt recvd vax 1300hrs @ 1600hrs exp nausea, weakness, when turning head to the lt feel like going to pass out & get nauseated, occasional ringing in ears;slept on rt side had exp some improvement this AM but problem w/head turning cont;										10/23/1995	10/23/1995	0		PUB	PUB				~ ()~~~In patient	MO95086	1						2	Asthenia; Nausea; Neck pain; Tinnitus; Asthenia; Nausea; Syncope; Tinnitus	FLU3~CONNAUGHT LABORATORIES~5F6119~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~5F61119~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0078722	11/07/1995	FL	2.0	2	.2	F	11/01/1995	DPH given 31OCT95 330PM; pt got hives a few hrs p/vax & mild wheezing given DPH;				Y					U	10/31/1995	10/31/1995	0	NONE	OTH	PVT	NONE	MRCP, shunt;no acute illness	MRCP, neuro shunt	~ ()~~~In patient		1						1	Asthma; Urticaria	FLU3~PFIZER\WYETH~4958104~1~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0078723	11/07/1995	AZ	30.0	30		F	10/30/1995	hives devel 8-10hrs following vax; general malaise;diarrhea;									Y	10/27/1995	10/27/1995	0		PUB	PVT	Vancerse inhaler; Proventil inhaler	asthma	asthma	~ ()~~~In patient		1						1	Diarrhoea; Malaise; Urticaria	FLU3~PFIZER\WYETH~4958077~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078724	11/07/1995	OH	43.0	42		F	11/01/1995	resp tightness, wheezing, coughing that progressed to muscle aches, vomiting & diarrhea lasting for about 4 1/2hrs-8PM until 1230AM;									Y	10/06/1995	10/06/1995	0		PVT	PVT				~ ()~~~In patient		1						1	Asthma; Cough; Diarrhoea; Dyspnoea; Myalgia; Vomiting	FLU3~CONNAUGHT LABORATORIES~5F61127~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078725	11/07/1995	LA	79.0	79		F	11/01/1995	severe pain in arm administered to prohibiting sleep on the same noc, 25NOV95										11/25/1995				PUB	UNK				~ ()~~~In patient		1						1	Insomnia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078726	11/07/1995	TX	70.0	70		F	11/03/1995	muscle in arm was very sore for 2 or 3 days & then sore yet for 4 or 5 days afterwards;It felt hot to touch & a 2 reddish circle was visable for several days p/first 2 days;									Y	10/14/1995	10/14/1995	0		OTH	UNK		NONE	arthritis	NONE~ ()~~~In patient		1						1	Myalgia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078727	11/07/1995	TX	32.0			F	10/25/1995	redness, tenderness & achy w/low grade fever;tx 1cc to inj site first 24hrs & warm compresses;APAP									Y	10/25/1995	10/25/1995	0	NA	MIL	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Myalgia; Pain; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61120~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078732	11/07/1995	TX	26.0	26		F	10/18/1995	24hrs p/vax arm very sore, fever 102 ear probe, rt deltoid swollen, warm & red;tender to painful to touch				Y					Y	10/16/1995	10/18/1995	2		PUB	UNK	TB-Mantoux by Connaught lot# 239911	NONE	1 kidney due to birth defect	~ ()~~~In patient		1						1	Ear pain; Myalgia; Oedema peripheral; Pain; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61120~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~5C71115~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0078738	11/07/1995	WA	35.0	35		F	11/02/1995	immed itching @ site progressed to 5cm sized red welt; by 2 1/2 hrs later red splotches on chest & reddened, burning eyes;welt @ site lasted 3-4 days;took one dose of DPH  30-45 p/inj;no resp signs/sxs devel									Y	10/24/1995	10/24/1995	0	NA	PUB	PVT	UNK	NONE	tested w/routine battery: all neg for allergy	~ ()~~~In patient		1						1	Eye pain; Injection site hypersensitivity; Pruritus; Rash; Urticaria	FLU3~PFIZER\WYETH~4958086~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078739	11/07/1995	WA	39.0	39		M	10/27/1995	pt recvd vax 26OCT95 @ 120PM noticed burise 645AM on rt temple, neck & back of head, c/o itching;denies SOB, diff swallowing; DPH given for itching/hives;seen by MD									U	10/26/1995	10/27/1995	1	NONE	OTH	OTH	Seldane; Prozac	NONE	hayfever	NONE~ ()~~~In patient		1						1	Pruritus; Urticaria	FLU3~PARKE-DAVIS~01495D~1~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0078740	11/07/1995	TX	52.0	52		F	10/30/1995	lt deltoid sore almost immed p/vax localized reddness & tenderness w/whelps & rash developing w/in 24hrs;low grade fever;									Y	10/25/1995	10/25/1995	0		UNK	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Pyrexia; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~5F61120~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078741	11/07/1995	IL	32.0	32		M	10/31/1995	pt recvd vax 23OCT95 & same day devel sore throat, aches, & low gever;24OCT95 t100, severe body aches, labored breathing, lightheaded, anorexic;25OCT95 2 red area @ site of inj, joint aches, was prescribed Biaxin by MD;				Y					Y	10/23/1995	10/23/1995	0	NONE	UNK	UNK	NONE	NONE	NONE		896040014L	1						1	Anorexia; Arthralgia; Bronchitis; Dizziness; Dyspnoea; Injection site hypersensitivity; Pharyngitis; Pyrexia	FLU3~PFIZER\WYETH~4958132~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~394963~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0078742	11/07/1995	IL	72.0	72		F	10/31/1995	pt recvd flu vax 23OCT95;that day pt was itching & swelling of arm @ inj site;2 days later devel swelling of throat w/o soreness, fever of 99 for 2 dyas then 2 days later devel cough & sinus problems;									U	10/23/1995	10/23/1995	0	NONE	OTH	PVT	Zestril, Calan	NONE	PCN, Ceclor, HTN, Hayfever	~ ()~~~In patient		1						1	Cough; Injection site oedema; Laryngospasm; Pruritus; Pyrexia; Rhinitis	FLU3~PFIZER\WYETH~4958132~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078745	11/07/1995	AZ	52.0	52		F		1/2hr p/vax had local itching @ site, then 6hrs later had large local rxn along w/entire body muscle aches, SOB & could not blow out to do a peak flow; pt has severe asthma chronically; felt very ill				Y					Y	10/11/1995	10/11/1995	0	FEV, 2.53	PVT	PVT	Theodur, Pred, Aerobid, Serevent, Nasocort, Albuterol inhaler, Tilade	chornic stable asthma	severe asthma chronically	~ ()~~~In patient		1						1	Asthma; Condition aggravated; Dyspnoea; Injection site reaction; Malaise; Myalgia; Pruritus	FLU3~CONNAUGHT LABORATORIES~5F61097~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~380957~UNK~SC~LA~PNEUMO (PNU-IMUNE)~1|TTOX~CONNAUGHT LABORATORIES~5C71122~UNK~IM~RA~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0078746	11/07/1995	NY	66.0	66		F	10/30/1995	loss of grip strength rt hand;cough, chest pressure				Y					Y	10/17/1995	10/17/1995	0	NA	PVT	PVT	Voltaren			~ ()~~~In patient		1						1	Chest pain; Cough; Myasthenic syndrome	FLU3~PARKE-DAVIS~02065P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~394958~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0078749	11/07/1995	PA	33.0	33		F	10/23/1995	18OCT95 750AM recvd vax-went home slept 8hrs-woke up had malaise-019OCT95 around 12n devel chills, was itchy around hip areas;20OCT95 devel hives both hips & back;21OCT95 had nausea, dry heaves & swelling of both hands & feet;purplish rash				Y					Y	10/18/1995	10/18/1995	0	NONE	UNK	UNK		NONE	PCN, sulfa, aldactone & E-Mycin	~ ()~~~In patient		1						1	Arthralgia; Chills; Nausea; Oedema peripheral; Pruritus; Rash; Urticaria; Vomiting	FLU3~PFIZER\WYETH~4958079~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0078750	11/07/1995	MN	40.0	40		M	10/27/1995	numbness on lt side top of head to waist arm;no loss of motor control x/face;felt hot/cold temps ok;problems in face have gotten worse arm is getting better;centered @ site of inj;				Y						10/20/1995	10/25/1995	5	saw neurologist; neg stroke MS, Bell's palsey atypical; MRI-tumor	PVT	PVT	NONE	NONE		~ ()~~~In patient		1						1	Chills; Hypokinesia; Injection site reaction; Paraesthesia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0078753	11/07/1995	IL	39.0	38		F	11/02/1995	pt had flu vax 11OCT95;lt arm devel redness, swelling around site x 12hrs;				Y						10/11/1995				PUB	OTH	Serevent-Aerobidy; Maxair inhaler;Volmax	NONE	asthma	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0078755	11/07/1995	IL	78.0	78		F	11/01/1995	pt recvd vax 23OCT95 & on 25OCT devel blotchiness & redness @ rt arm inj site;26OCT had rash on chest & abd;									U	10/23/1995	10/25/1995	2	NONE	OTH	PVT	unk	NONE	unk	~ ()~~~In patient		1						1	Injection site hypersensitivity; Rash; Rash maculo-papular	FLU3~PFIZER\WYETH~4958132~UNK~L~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~394963~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0078756	11/07/1995	TN	84.0	84		F	10/26/1995	pt was given vax & p/waiting 20min went to car where began having SOB, chest pain, & hip pain;pt had 02 applied BP 160/82,P78, ambulance was summoned & 2:00 transported to ER: pt was discharged to home @ 230PM;				Y					Y	10/26/1995	10/26/1995	0	NONE	PUB	PUB	unk	NONE	codeine, valium, PCN	~ ()~~~In patient	TN95111	1						1	Chest pain; Dyspnoea; Hypertension; Pain	FLU3~CONNAUGHT LABORATORIES~5F61116~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1541A~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0078757	11/07/1995	IL	47.0	47		F	10/26/1995	sl fever 24OCT95 began 7PM;hives all over body began 25OCT95 6PM;these hives lasted for approx 24hrs;pt exp soreness in roof of mouth				Y					Y	10/24/1995	10/25/1995	1		PUB	PUB		NONE	flowxin	~ ()~~~In patient	IL950119	1						1	Pyrexia; Stomatitis; Urticaria	FLU3~CONNAUGHT LABORATORIES~5F61119~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078758	11/07/1995	IL	22.0	22		M	10/30/1995	red blotches on arm, chest, & abd accompained w/fine rash									Y	10/27/1995	10/30/1995	3		PUB	PUB	Erthromycin	cold but no fever		~ ()~~~In patient	IL950120	1						1	Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~5F61119~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078759	11/07/1995	IL	47.0	47		F	10/30/1995	rt arm swollen, red, hot arm in area of inj couldn't lift arm-swelling traveled down arm to elbow area by evening of 27OCT-lasted until 29OCT-no more pain but burning & itching on 30OCT									Y	10/26/1995	10/27/1995	1	NA	OTH	PUB	Premarin	NONE	PCN	NONE~ ()~~~In patient	IL950121	1						1	Hypokinesia; Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Pain; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F6119~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0151B~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0078766	11/07/1995	SD	28.0			F	11/06/1995	nausea, chills, fever, diarrhea, classic flu sxs, h/a for 48hrs p/vax									Y					UNK	UNK				~ ()~~~In patient		1						1	Chills; Diarrhoea; Headache; Influenza; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078767	11/07/1995	OK	43.0	43		F	11/03/1995	weakness in arm, cannot grasp thing-cont for a couple of wks w/grasping problems;										10/26/1995				UNK	UNK				~ ()~~~In patient		1						1	Hypotonia; Myasthenic syndrome	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078768	11/07/1995	WI	84.0	84		M	11/03/1995	diarrhea, chills									N	11/02/1995	11/03/1995	1	NONE	PVT	OTH	Tetracycline, Coraguard, Synphroid, Lorazepan, Mirazapan	NONE	stroke, depression	NONE~ ()~~~In patient		1						1	Chills; Diarrhoea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078769	11/07/1995	NY	65.0	65		F	11/07/1995	cold sxs, sore throat, diff swallowing, cold going into chest									N	11/02/1995	11/04/1995	2	NONE	OTH	OTH	NONE	NONE	NONE	pt exp cold @ 64yrs w/flu vax~ ()~~~In patient		1						1	Laryngospasm; Lung disorder; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078771	11/07/1995	MA	64.0	64		U		had flu shot 14OCT95 & next day devel a fever, h/a, sore throat, aching joints & muscles, loss appetite-was sick for 10 days;									Y	10/14/1995	11/05/1995	22		PUB	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient	MA9525	1						1	Anorexia; Arthralgia; Headache; Myalgia; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61134~UNK~L~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078775	11/07/1995	KS	80.0	80		F	10/30/1995	pt noted profuse perspiration, clamminess, vertigo, pale color, sensation of slowed heart rate;pt went to ER; BP was 204/90;pt was given procardia sublingual & 02; BP readings 192/94 10mins, 207/80, 159/82;135PM was 132/68 pt observed				Y					Y	10/03/1995	10/03/1995	0	cardiac enzymes, EKG	PUB	PUB	Inderol; Paxil	NONE	PCN	NONE~ ()~~~In patient	KS95054	1						1	Bradycardia; Hyperhidrosis; Hypertension; Pallor; Vertigo	FLU3~PFIZER\WYETH~4958123~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0081528	11/07/1995	MI	37.0	36		M	06/28/1995	recvd vax;eve devel severe pain in back;could not move/walk;devel intermittent numbness of legs,feet;devel flu like sx w/ T 103-104;2 days later,to MD who tx w/ motrin,muscle relaxants;pos HLA;MD dx ankylosing spondylitis;unrelated to vax;				Y					N	11/09/1994	11/09/1994	0	HLA B27 pos; MRI(head) nl;EMG (arm,leg) mild carpel tunnel synd in rt arm on nov94;SER's(upper & lower) nl on nov94;MRI neck mild bulge C5-6, C6-7, no cord compression jan95;	PVT	PVT	claritin; pamelor	none	pt had hx of sinus infect & allergies; on 7apr93 c/o rt arm & leg numbness;	~ ()~~~In patient	895213001J	1						1	Back pain; Bone disorder; Hypokinesia; Influenza; Laboratory test abnormal; Neuropathy; Paraesthesia; Tenosynovitis	FLU3~PFIZER\WYETH~4948102~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0081529	11/07/1995	FL				F	06/21/1995	pt recvd vax;blisters at site of inject where she gets cuts or bruises;inadvertently recvd a 2nd flu shot;				Y					N	10/01/1994	01/01/1995	92		PVT	PVT	dyazide, aldomet	none	na	~ ()~~~In patient	895220003L	1						1	Dermatitis bullous	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0081530	11/07/1995	TX	38.0			M	06/27/1995	pt recvd vax; had chronic dizziness since flu vax;									U	09/01/1994	09/01/1994	0		UNK	UNK		unk			895220005L	1						1	Dizziness	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081531	11/07/1995	NJ	51.0	50		F	09/15/1995	pt recvd vax accidentally;usually avoid flu vax due to hx of GBS;devel psychomotor sx;had sz while sleeping & was examined in er;dx of epilepsy & started on dilantin;				Y					U	10/04/1994	01/27/1995	115		PVT	PVT	dilantin;	unk	hx of GBS but not assoc w/ flu vax;	~ ()~~~In patient	895279002J	1						1	Convulsion	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0078631	11/08/1995	TX	68.0	68		F	11/03/1995	swollen trachea;almost closed off;admitted to ICU treated w/steroids & antihistamines;discharged 20OCT95 @ 8PM 23OCT95 4AM devel hives & still being treated;As of 25OCT rx w/Visodryl, steroids;			Y	Y	Y	2			U	10/18/1995	10/18/1995	0		OTH	OTH	HBP	NONE	HBP	pt exp rxn @ age 65 w/Td vax~ ()~~~In patient	CO6280	1						2	Laryngeal oedema; Urticaria; Dyspnoea; Hypersensitivity; Laryngeal oedema; Urticaria	FLU3~CONNAUGHT LABORATORIES~5F61166~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~5F61166~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0078632	11/08/1995	OH	79.0	79		F	11/03/1995	nausea & vomiting, devel aspiration pneumonia & adm to hosp 16OCT95; lt arm very swollen, red & sore w/dx of cellulitis;					Y				U	10/15/1995	10/15/1995	0		OTH	OTH	Zantac, Amytriptilin		Alsheimers, s/p CVA	NONE~ ()~~~In patient	CO6277	1						2	Cellulitis; Infection; Myalgia; Nausea; Oedema peripheral; Respiratory disorder; Vasodilatation; Vomiting; Cellulitis; Nausea; Oedema peripheral; Pain; Pneumonia; Vasodilatation; Vomiting; Cellulitis; Nausea; Oedema peripheral; Pain; Pneumonia; Vomiting	FLU3~CONNAUGHT LABORATORIES~5F61166~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~107613~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~CONNAUGHT LABORATORIES~5F61166~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~107613~UNK~IM~LA~PNEUMO (PNEUMOVAX)~2|FLU3~CONNAUGHT LABORATORIES~5F61166~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~1076B~UNK~IM~~PNEUMO (PNEUMOVAX)~3	USA	Hospitalisation	Influenza
0078633	11/08/1995	FL	80.0	80		F	11/03/1995	devel pleurisy 24hrs p/vax;hospitalized for 7-10 days & tx w/ATB;					Y	10			Y	09/28/1995	09/29/1995	1		OTH	OTH		NONE		NONE~ ()~~~In patient	CO6274	1						2	Pleural disorder; Pleural disorder	FLU3~CONNAUGHT LABORATORIES~5F61135~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~5F61135~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0078820	11/08/1995	MA	69.0	69		F	10/20/1995	pt recvd vax 18OCT95 called 20OCT c/o 3 red area that was painful;generally felt lousy but had not taken temp;31OCT95 spoke w/ pt arm did swell up x 4 days, painful 4-5 days;pt saw MD put on PCN dx strep germ									Y	10/18/1995	10/20/1995	2		PUB	UNK				~ ()~~~In patient	MA9510	1						1	Infection; Malaise; Oedema peripheral; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61134~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078821	11/08/1995	MA	47.0	47		F	11/01/1995	faint 2days ago; lt arm swollen & red 101 went hlth stop;									Y	10/30/1995	10/30/1995	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MA9513	1						1	Oedema peripheral; Pyrexia; Syncope; Vasodilatation; Injection site pain; Myalgia; Oedema; Pain; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61134~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~394963~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1|FLU3~CONNAUGHT LABORATORIES~5F61134~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~394963~UNK~~LA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0078822	11/08/1995	MA	66.0	66		F	10/31/1995	12hrs p/vax pt exp pain in lt arm x 3 days;Friday AM arm became very red, swollen-glands lump went to MD put on Cipro & DPH;Saturday 10AM lungs congested, breathing labored;Tuesday started to feel better, but cont to cough;felt weak, tired				Y					Y	10/18/1995	10/19/1995	1	Not known	PUB	PUB	NONE	NONE	asthma in the past-allergies-grass, dust	~ ()~~~In patient	MA9517	1						1	Asthenia; Cough; Dyspnoea; Lung disorder; Lymphadenopathy; Oedema peripheral; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61134~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1559A~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0078824	11/08/1995	MA	39.0	39		F	11/02/1995	several hrs p/vax legs felt very weak (as if had been standing lal day & needed to sit down);sensation subsided by Friday AM;when woke up Thursday AM felt nauseated;vomited twice but by noon time felt fine									Y	10/17/1995	10/17/1995	0	NA	OTH	UNK	Beaconese		non allergic rhinitis	NA~ ()~~~In patient	MA9514	1						1	Myasthenic syndrome; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~5F61134~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078825	11/08/1995	MA	69.0	69		M	10/25/1995	fever, ha/, chills, cough, heavy cold-like szs began about 6-8hrs p/vax									Y	10/24/1995	10/24/1995	0	NONE	PUB	PUB		NONE	NA	~ ()~~~In patient	MA9512	1						1	Chills; Cough; Headache; Pharyngitis; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61134~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078826	11/08/1995	MA	75.0	75		F	10/24/1995	very congested, teeth hurt, throat sore, eyes bloodshot, voice husky									Y	10/23/1995	10/23/1995	0	NONE	UNK	PUB		NONE	NKA	~ ()~~~In patient	MA9511	1						1	Conjunctivitis; Dysphonia; Pain; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61134~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078836	11/09/1995	NJ	71.0	71		F	11/02/1995	Monday-inflamation began;Tues swelling @ 1 very sore ice/Ibuprofin shrank swelling;Wed swelling migrated towards lower inner arm									Y	10/30/1995	10/30/1995	0	NONE	PUB	PUB		NONE	NONE	pt exp rxn in 1993 @ 69yrs old w/flu vax dose 1~ ()~~~In patient	NJ9550	1						1	Oedema peripheral; Vasodilatation	FLU3~PARKE-DAVIS~01495P~3~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~390934~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0078837	11/09/1995	NY	75.0	75		F	10/30/1995	9PM 25OCT rt arm knot, swollen @ site of inj cleared w/in 24hrs;26OCT95 during noc last through following day nausea, diarrhea, vomiting, clammy sweats, chills;another 2 days a/felt well									Y	10/25/1995	10/25/1995	0	NONE	PUB	PUB	APAP	NONE	arthritis, PCN	~ ()~~~In patient	NYS95059	1						1	Chills; Diarrhoea; Hyperhidrosis; Injection site hypersensitivity; Injection site oedema; Nausea; Vomiting	FLU3~PARKE-DAVIS~01195P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1559A~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0078839	11/09/1995	NJ	73.0	72		M	11/06/1995	fever of 101-h/a all muscles sore-heavy congestion of lungs, extremely tired & weak-noc sweats-chills-loss of appetite; MD gave pt Biaxin which pt is still on				Y					Y	10/23/1995	10/24/1995	1		PUB	PUB	vasotec	hypertension-emphyzema		~ ()~~~In patient	NJ9549	1						1	Anorexia; Asthenia; Chills; Headache; Hyperhidrosis; Lung disorder; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0078846	11/09/1995	NY	34.0	34		M	10/21/1995	aches, fever, sl chills, restlessness started 4hrs lasted 5 days, fungal ear infect 7days p/shot;ASA q 4-6hrs									Y	10/13/1995	10/13/1995	0	NONE	PUB	PVT	Xanax, Pepcid, Vanconase	ear infect, fungal type	asthma, panic disorder, hiatal hernia	~ ()~~~In patient		1						1	Agitation; Chills; Infection; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078848	11/09/1995	MA	33.0	33		F	11/02/1995	pt states exp swelling of the tongue, diff swallowing & chills approx 4hrs p/vax;these sxs lasted approx 2hrs & did not seek tx									Y	11/01/1995	11/01/1995	0	NA	PVT	PUB	NONE	NONE	asthma (aerobid & proventil inhalers PRN)	~ ()~~~In patient		1						1	Chills; Dysphagia; Tongue oedema	FLU3~CONNAUGHT LABORATORIES~5F61134~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~MASS. PUB HLTH BIOL LAB~TD56~UNK~~RA~TD ADSORBED (TDVAX)~1	USA		Influenza
0078851	11/09/1995	NY	65.0	65		F		achy all over all day;2nd day p/shot;temp 100 & cough in evening only 26OCT-31OCT nothing p/that time still sl cough;									Y	10/24/1995	10/26/1995	2		UNK	UNK		NONE	allergic Butazolodin AKKA & Cipro	~ ()~~~In patient		1						1	Cough; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078856	11/09/1995	CA	65.0	65		F	10/16/1995	pt states recvd vax 12OCT95 & that afternoon arm was sore, Friday had chills, fever & had emesis; Saturday still some pain @ the site under armpits to point unable to move very well;inj site was inflamed & reddened to the shoulder									N	10/12/1995	10/12/1995	0	NONE	OTH	OTH	HTN0diag Tenormin, Diuril	NONE	HTN	~ ()~~~In patient	CA95138	1						1	Chills; Hypokinesia; Injection site hypersensitivity; Injection site inflammation; Myalgia; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~4958151~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~UNKNOWN MANUFACTURER~1541A~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0078857	11/09/1995	CA	70.0	70		M	10/09/1995	4OCT95 pt recvd vax & came into clinic w/ c/o redness below site, no swelling, no c/o pain, no fever according to RN									Y	10/04/1995	10/04/1995	0	NONE	OTH	PUB	Zestril, Lopid	NONE	HTN	~ ()~~~In patient	CA95136	1						1	Vasodilatation	FLU3~PFIZER\WYETH~4958151~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1541A~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0078861	11/09/1995	CA	45.0	45		F	10/10/1995	redness, heat, swelling @ inj site									Y	10/03/1995	10/04/1995	1	NONE	PUB	PUB	Synthroid, Premarin	NONE	NONE	~ ()~~~In patient	CA95128	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4958151~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081532	11/09/1995	FL				U	09/08/1995	pt recvd vax; devel an inject site rxn characterized by redness, swelling & pain;									U					PVT	PVT	unk	unk		~ ()~~~In patient	895278004J	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081533	11/09/1995	FL	44.0			F	09/11/1995	pt recvd vax; devel swelling & redness which persists in the arm of inject, limits range of motion;									U	09/08/1995	09/08/1995	0		PVT	PVT	estrace, xanax	unk		~ ()~~~In patient	895278005J	1						1	Hypokinesia; Oedema peripheral; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081534	11/09/1995	FL	72.0			F	09/11/1995	pt recvd vax;devel redness & pain in the arm of inject;sx resolved									Y	09/07/1995	09/07/1995	0		PVT	PVT	nitropatch, vasotec;			~ ()~~~In patient	895279001J	1						1	Pain; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081535	11/09/1995	OH				U	09/22/1995	pt recvd vax; exp pain, bruising & blotching at inject site;									U	09/21/1995	09/21/1995	0		OTH	OTH		unk	unk	~ ()~~~In patient	895279003J	1						1	Ecchymosis; Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081536	11/09/1995	CA				U	09/22/1995	pt recvd vax; exp fever, myalgia & localized pain persisting for more than 1 wk p/ vax;									U	09/05/1995				PVT	PVT	tine test	unk		~ ()~~~In patient	895279005J	1						1	Injection site pain; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4958120~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081537	11/09/1995	TX				U	09/27/1995	pt recvd vax; exp redness, swelling & welts at inject site;									U					PVT	PVT		unk	unk	~ ()~~~In patient	895279006J	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4958115~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078821	11/13/1995	MA	47.0	47		F		swelling/erythema/pain/fever 101 po/myalgia; +discomfort @ inj site-lt deltoid; flu vax & pneumovax given same site									U	10/30/1995	10/31/1995	1	NONE	PVT	UNK		NONE	NONE	~ ()~~~In patient	MA9513	1						2	Oedema peripheral; Pyrexia; Syncope; Vasodilatation; Injection site pain; Myalgia; Oedema; Pain; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61134~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~394963~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1|FLU3~CONNAUGHT LABORATORIES~5F61134~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~394963~UNK~~LA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0078866	11/13/1995	IN	59.0	59		F	11/06/1995	immed onset of myalgias 2hrs p/vax;severe pain of large muscle groups;paresthesias in feet & legs starting approx 24OCT;gait is diff;some incoordination in hands;dx GBS					Y	4			U	10/05/1995	10/05/1995	0	Glucose 70; Protein 118; Myeline base protein 1.1;Total protein 118;albumin 86.6;IGG/ALB ratio 0.099;CSF index 0.477; IGG CSF 8.64;WBC 1;RBC 0;total protein 5.5; albumin 3.1; a/G ratio 1.64; ALT 59; arsenic neg; lead 2.2; ANA 1:40;	PVT	PVT			NKA	~ ()~~~In patient		1						1	CSF test abnormal; Guillain-Barre syndrome; Hypokinesia; Movement disorder; Myalgia; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4958074~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0078867	11/13/1995	MD	64.0	64		F	11/07/1995	@ home 1PM felt unwell while eating lunch;@ 1:30 began coughing, eyes red, eyelids darkened;2:30 p/resting 1/2hr, heart rate was 120;went to ER; adm for observation & test;neg findings (reported by husband);heart rate remained elevated;				Y	Y	1			Y	11/03/1995	11/03/1995	0	scan for embolism, blood test, thalliam stress test, CXR, EKG	OTH	PVT	takes librax	NONE-elevated cholesterol	allergic to doxycycline			1						1	Conjunctivitis; Cough; Malaise; Tachycardia	FLU3~CONNAUGHT LABORATORIES~5F61119~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0078870	11/13/1995	PA	70.0	70		M	11/04/1995	pt admitted w/sepsis synd 24 hrs pos vax cultures neg;pt expired;no autopsy;acute sepsis synd poss d/t vax	Y	09/25/1995							N	09/24/1995	09/24/1995	0		OTH	PVT				~ ()~~~In patient		1						1	Sepsis	FLU3~MEDEVA PHARMA, LTD.~E2835HA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0078874	11/13/1995	MI	54.0	54		F	10/20/1995	pt recvd vax 9OCT95 & 4-6hrs later pt coughing & bringing up brown color sputum;pt went to bed 1130PM had diff breathing;then left bed & sat in a chair until 345AM;pt taken to hosp & adm dx pneumonia, emphysema,asthma, bronchitis					Y	8			Y	10/09/1995	10/09/1995	0		PUB	PUB	Cartaven, Isadil, Lasix, Theodor, Parafore, Ioped, baby ASA, insulin	NONE	emphysema, heart attack 1983 or 1984, arthritis, diabetes	~ ()~~~In patient	MI95123	1						1	Asthma; Bronchitis; Condition aggravated; Cough; Drug ineffective; Dyspnoea; Emphysema; Pneumonia	FLU3~PFIZER\WYETH~4958114~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~394936~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0078875	11/13/1995	IA	73.0	73		F	11/07/1995	hives, over entire body itching, nausea, loss of memory, double vision, trouble focusing; Deltazone treatment @ ER, Seldane, Lrazepam seperate treatments;				Y					U	10/26/1995	10/26/1995	0	blood test (nl)	PVT	PUB	Potassium, L-THyroxin, ASA, Furosemide	NONE	enlarged heart, check sodium level	NONE~ ()~~~In patient		1						1	Amblyopia; Amnesia; Diplopia; Nausea; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0078876	11/13/1995	VA	70.0	70		F	11/10/1995	weakness, lt hand/finger, paresthesias; onset 7-10 days p/vax resolving but not gone by 10NOV95;				Y					N	10/15/1995	11/06/1995	22	NONE	PVT	PVT	Synthroid, Doxcycycline, ?	bronchitis 1wk later	hypothyroid, hysterechy	~ ()~~~In patient		1						1	Asthenia; Paraesthesia	FLU3~PFIZER\WYETH~4958103~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0078879	11/13/1995	GA	76.0	76		F	11/07/1995	12OCT95 AM got the flu & teeth chattering 13 & 14OCT fever, vomiting, t102, diarrhea extreme sweats;17OCT saw MD who found massive blood in urine & treated for urinary infect-cystitis-Macrobid prescribed				Y					Y	10/12/1995	10/12/1995	0	urine culture	OTH	UNK		unk perhaps onset of cystitis	NONE	NONE~ ()~~~In patient		1						1	Chills; Cystitis; Diarrhoea; Haematuria; Hyperhidrosis; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0078880	11/13/1995	MA	26.0	26		F	10/31/1995	3 hrs /p vaxes exp scratchy,irritated throat unable to clear, red & watery eyes, flush-hot feeling; previous flu vax w/o adverse effects				Y					Y	10/27/1995	10/27/1995	0	none	PUB	UNK	none	resolved URI	none	none~ ()~~~In patient		1						1	Conjunctivitis; Dry mouth; Lacrimal disorder; Pharyngitis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61134~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~394963~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0078882	11/13/1995	CO	56.0	56		F	10/31/1995	pt recvd vax & devel sore throat, severe h/a, chills, fever, all over body aches (severe pain), dizziness, nausea, lightheadedness, diarrhea;got flu shot on 25OCT 1030AM felt fine the rest of day;3AM 26OCT95 awoke coughing w/full-blown cold				Y					N	10/25/1995	10/26/1995	1	went to MD who check ears, throat, stomach & breathing-MD stated pt had the flu	MIL	MIL		NONE	NONE	~ ()~~~In patient		1						1	Chills; Diarrhoea; Dizziness; Headache; Myalgia; Nausea; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61133~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078887	11/13/1995	IN	26.0	26		F	11/08/1995	3PM pt devel rash on skin & itching				Y					Y	10/31/1995	10/31/1995	0		OTH	OTH				~ ()~~~In patient		1						1	Pruritus; Rash	FLU3~PFIZER\WYETH~4958137~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0078889	11/13/1995	MS	54.0	54		F	11/01/1995	pt recvd flu vax 25OCT95 next day looked in mirror when applying deoderant & lymph node in rt arm was swollen size of soft ball & tender & stayed tender about 2 dasy;saw MD 26OCT95 sait it was probably immune system reacting to shot				Y					Y	10/25/1995	10/26/1995	1		PUB	PVT	unk	NONE	NONE	~ ()~~~In patient	MS95052	1						1	Lymphadenopathy; Pain	FLU3~PARKE-DAVIS~01285P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0078893	11/13/1995	MI	36.0	36		F	10/23/1995	20OCT95 5PM itching on lower arm where inj given, progressed to other arm, legs & trunk;6PM hives began developing;began DPH immed then q 6 hrs 21OCT95 AM began looking better, by 5PM hives returned;went to ER given Solumedrol 630PM;				Y					Y	10/19/1995	10/20/1995	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MI95133	1						1	Injection site hypersensitivity; Pruritus; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E2725HE~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0078894	11/13/1995	MI	21.0	20		F	11/01/1995	complete redness on chest & back, raised;as of 21OCT95AM was extremely itchy;began topical DPH;saw MD on 1NOV95;itching/rash beginning to improve as 1NOV95				Y					Y	10/19/1995	10/20/1995	1	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MI95132	1						1	Pruritus; Rash maculo-papular; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E2725HE~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0078896	11/13/1995	MI	47.0	47		F	10/25/1995	immed felt vax moving up neck veins-lt sied of neck;stayed @ clinic 30 to assure no rxn;felt lt arm tingling all immed rxn 5 days later; felt pressure or as if someone was pushing on base of neck;19OCT95 saw MD				Y					N	10/11/1995	10/11/1995	0	blood tests: thyroid, iron-def-anemia, EKG, CXR, MIR acheduled for 26OCT95	PUB	PUB	NONE	NONE	environmental allergies eg car fumes, plastics, chemicals (chem aerosols)	NONE~ ()~~~In patient	MI95128	1						1	Neck pain; Paraesthesia	FLU3~PFIZER\WYETH~4958114~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0078897	11/13/1995	MI	54.0	54		F	10/12/1995	11OCT95 pt phoned to report 1 1/2 redness around inj site;painful arm (required darvocet to help alleviate pain) during noc a/;12OCT95 f/u call to client-now feels muscle pull under the arm & redness has cont to enlarge 2 diameter;				Y					Y	10/10/1995	10/10/1995	0	NONE	PUB	PUB	NONE	NONE	rheumatic heart dis-valve problems	NONE~ ()~~~In patient	MI95127	1						1	Injection site hypersensitivity; Injection site pain; Myalgia	FLU3~PFIZER\WYETH~4958114~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~394936~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0078898	11/13/1995	MI	67.0	67		M	10/12/1995	12OCT95 pt called to report vaxed 5OCT95;only sl tenderness @ site of inj;7OCT95 noted numbness on tongue lack of sensation but could move in all directions;9OCT95 eyelid somewhat drooped-eye waters;12OCT95 mouth/lip sensation dec				Y					N	10/05/1995	10/07/1995	2		PUB	PUB	Aspirin	NONE	NONE-low BP-no tx (meds given)	NONE~ ()~~~In patient	MI95126	1						1	Eye disorder; Facial palsy; Injection site pain; Paraesthesia; Paraesthesia oral	FLU3~PFIZER\WYETH~4958114~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0078899	11/13/1995	MD	46.0	46		F	11/03/1995	inflamed rt arm about 3 1/2-4inches in diameter;was very warm to touch & sore;began 24hrs p/vax lasted 4 days									Y	10/31/1995	11/01/1995	1	NONE	OTH	OTH	Birth control pills; ovum novem 28	NONE	MVP	~ ()~~~In patient		1						1	Injection site inflammation; Pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078900	11/13/1995	VA	48.0	48		F	11/08/1995	cough, injected burning conjuncting 4hrs p/vax then 6hrs later devel fever & chills									Y	11/03/1995	11/03/1995	0	NA	OTH	PVT	Primar, Digoxin, Curaric	NONE	PCN, Codeine, Atmal fibrillation	NA~ ()~~~In patient		1						1	Chills; Conjunctivitis; Cough; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61115~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078901	11/13/1995	MA	63.0	63		F		typical few sxs (no fever) no real sick, but sore throat, chills, aches, sinus									N	10/27/1995	10/29/1995	2		PUB	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						1	Chills; Influenza; Myalgia; Pharyngitis; Sinusitis	FLU3~PFIZER\WYETH~4958076~1~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078902	11/13/1995	SD	40.0	40		F	11/07/1995	exp burning sensation when fluid put in rt arm much bleeding;arm remained sore 2 firm knot @ site for several days;nauseaous, severe h/a, diarrhea (p/eating) several timeas a day;loss of appetite, fever 98.9-100.7;muscle & bone soreness;									N	10/25/1995	10/25/1995	0		PVT	OTH	Wellbutrin;Naldecon;Desyerl	NONE	yearly allergies outside & inside, foods, wool, sulfa	pt exp same sxs as above @ 39yrs w/flu vax;sibling exp same rxn as above @ 44yrs~ ()~~~In patient		1						1	Anorexia; Hypokinesia; Injection site mass; Injection site pain; Myalgia; Nausea; Pyrexia; Thinking abnormal	FLU3~PFIZER\WYETH~4958085~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078903	11/13/1995	OK	57.0	57		F	10/31/1995	approx 10-20mins p/flu shot;pt reported tingling @ top of forehead;erythema on face;pt states resolved in 20min;pt states same thing happened last year									Y	10/27/1995	10/27/1995	0	denies	UNK	UNK				~ ()~~~In patient		1						1	Paraesthesia; Rash	FLU3~PFIZER\WYETH~4958115~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078908	11/13/1995	AZ	69.0	69		M		congestion, sore throat, mild h/a, nasal & bronchial secretions yellow;sick 24hrs p/vax;seen office 28SEP temp inc but cough persisted 1wk; resolution thereafter									Y	09/25/1995			NONE	PVT	PVT	Kerlone, Cardizem, Paxil, Prilosee	NONE	prev illness spring 95 Pancrotitis, PUD, HTN, CTD	NONE~ ()~~~In patient		1						1	Bronchitis; Cough; Headache; Lung disorder; Pharyngitis; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61114~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078909	11/13/1995	MD	36.0	36		F	11/08/1995	several days p/vax pt reported a rash on trunk, arms & hands;rash is sl pruritic;self tx w/DPH-some relief;rash persisted since immunization given 10OCT95;similar rxn recalled last yr not reported prior to vax									Y	10/10/1995	10/12/1995	2		OTH	PUB	NA	NA	some ATB, seasonal allergies	pt exp similar rxn last yr not reported prior to this immunization~ ()~~~In patient		1						1	Purpura	FLU3~PARKE-DAVIS~00875P~2~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0078911	11/13/1995	OR	70.0	70		M		chills, fever, dizziness, nauseated;pt devel sxs 2-3hrs p/flu vax;pt recvd 1/2 doses-condition lasted for 1wk;									Y	10/30/1995	10/30/1995	0		PVT	PVT		hypertension	HTN, fibromyalgia	~ ()~~~In patient		1						1	Chills; Dizziness; Nausea; Pyrexia	FLU3~PFIZER\WYETH~4958086~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078912	11/13/1995	NY	33.0	33		F	11/09/1995	severe pain @ the site of the inj & throughout the entire shoulder & arm area (2 days); no swelling or fever); advil taken									Y	10/05/1995				PVT	PVT	NA	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site pain; Pain	FLU3~CONNAUGHT LABORATORIES~5F61145~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078914	11/13/1995	CA	41.0	41		F	10/24/1995	2 days p/vax pt devel large tender axillary lymph node;3 days p/vax maculopapular rash; mos prominant on lt arm;										10/21/1995	10/23/1995	2		UNK	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						1	Lymphadenopathy; Rash maculo-papular	FLU3~PFIZER\WYETH~4958126~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078915	11/13/1995	OR				U		pt states had rxn-swelling, redness golf ball size knot, took 4-5 days to dec in size;pt broke out w/sore 4-5in long; tenderness;									Y					PVT	PVT		dermatitis		~ ()~~~In patient		1						1	Oedema peripheral; Pain; Skin nodule; Vasodilatation	FLU3~PFIZER\WYETH~4958086~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078921	11/13/1995	AR	71.0	71		M	11/07/1995	myalgia 2hrs, chills-rigors 2hr, malaise 24-48hr, insomnia									Y	11/04/1995	11/04/1995	0	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Anaemia; Chills; Insomnia; Malaise; Myalgia; Purpura; Thrombocytopenia	FLU3~CONNAUGHT LABORATORIES~5F61006~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078923	11/13/1995	MI	79.0	78		F	10/27/1995	pt recvd vax 26OCT95 2PM & began swelling of rt arm w/in 1hr called daughter @ 830PM stating arm was swollen the size of a fist hot & painful;recvd DPH & Ibprophin									Y	10/26/1995	10/26/1995	0	NONE	PUB	PUB	Hypertenison meds		HTN-mild	~ ()~~~In patient	MI95129	1						1	Oedema peripheral; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4958114~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~394936~2~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0078928	11/13/1995	WY	57.0	57		F	10/29/1995	24OCT95 OV rt arm area of inj burised, below large red, swollen, inc temp;pt c/o itching;leaving town today;DPH gor discomfort of itching;										10/18/1995	10/19/1995	1		PUB	PUB				~ ()~~~In patient	WY9603	1						1	Ecchymosis; Oedema peripheral; Pruritus; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4958117~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~4L61153~2~IM~RL~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0078929	11/13/1995	AK	25.0	25		F	11/06/1995	pt devel hives w/in 30min of vax;took PDH & Chlor-trimeton @ home & hives disappeared									Y	11/03/1995	11/03/1995	0	NA	PUB	PUB	NONE	NONE	NONE	NA~ ()~~~In patient	AK95040	1						1	Urticaria	FLU3~PFIZER\WYETH~40848351~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078930	11/13/1995	WI	75.0	75		M	11/04/1995	onset shaking 1030PM;fever during noc severe body aching;pain in palm of lt hand									Y	10/31/1995	10/31/1995	0	NONE	PUB	PUB	Tenormin, HCTZ, Numerous ASA	cardio vascular disease	cardio vascular disease	NONE~ ()~~~In patient		1						1	Myalgia; Pain; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078931	11/13/1995	PA	41.0			F	11/04/1995	p/receiving flu shot, SOB & palpitations occurred w/in 15mins;pt recvd DecadronIM & pred				Y					Y	10/16/1995	10/16/1995	0		PUB	PUB		NONE	NONE	~ ()~~~In patient		1						1	Dyspnoea; Palpitations	FLU3~PARKE-DAVIS~01185P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0078934	11/13/1995	WY	61.0	61		F	10/20/1995	pt recvd vax 10OCT95;11OCT95 AM already showing signs of infect, high fever, arm swollen shoulder to elbow hosp & culture done;results not known @ prison & on IV				Y						10/10/1995	10/11/1995	1		PUB	PUB				~ ()~~~In patient	WY9602	1						1	Cellulitis; Oedema peripheral; Pyrexia	FLU3~PFIZER\WYETH~4958117~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~4L61153~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0078937	11/13/1995	LA	22.0	22		M		pt recvd flu vax 23OCT95 & devel pin in proximal aspect of arm in axillary aspect of same arm as vax (pain next day)									Y	10/23/1995			CBC-WBC	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Pain	FLU3~CONNAUGHT LABORATORIES~5F61116~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078177	11/14/1995	OR	43.0	43		F	12/22/1994	pt reported malaise, fever 102, weakness, bad cough, lassitude went to ER-had been recoverning from bronchitis (3wk hx) & MD gave pt flu vax;				Y					Y	12/13/1994	12/13/1994	0		PUB	PVT	Duracef	bronchitis	lupus, chornic liver disease, non a non b hepatitis, uterine CA age 25 w/hysterectomy, thyrordictomy receives acupuncture	NA~ ()~~~In patient		1						2	Asthenia; Condition aggravated; Cough; Malaise; Pyrexia; Asthenia; Cough; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51024~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~4F51024~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0078942	11/14/1995	TX	59.0	59		F	11/07/1995	w/in 8hrs had a bad case of the flu;had to stay in bed 2 1/2 days go to the MD;sick for about a wk				Y					Y	10/14/1995	10/14/1995	0		PUB	UNK		NONE	NONE	NONE~ ()~~~In patient		1						1	Influenza	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0078944	11/14/1995	FL	40.0	39		M	11/02/1995	day p/vax arm became very sore & was diff to move; c/o severe soreness off & on APAP controls sxs; seen by clinic MD;dx traumatic myalgia f/u w/PMD:				Y						10/16/1995	10/17/1995	1	NA	OTH	OTH	Tagamet	NA	asthma	NA~ ()~~~In patient		1						1	Hypokinesia; Myalgia	FLU3~CONNAUGHT LABORATORIES~5F61134~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078946	11/14/1995	CA	47.0	47		F	10/31/1995	30OCT95 several hrs p/vax began to have burning in rt shoulder & progressively stiff neck; seen 31OCT-no reddness @ site, guarding of rt shoulder, appearance of stiffness but inconsistent findings on exam;				Y					N	10/30/1995	10/31/1995	1	NONE	OTH	PUB	NONE	NONE	NKDA, no medical conditions	NONE~ ()~~~In patient		1						1	Nuchal rigidity; Pain	FLU3~PFIZER\WYETH~4958151~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0078952	11/14/1995	CO	52.0	52		F	11/09/1995	pt c/o sore arm when elevating arm above shoulder lever;no rash, swelling, discoloration, not hot to touch;									U	10/17/1995	10/18/1995	1	NONE	PUB	PUB		NONE	NONE	~ ()~~~In patient		1						1	Myalgia	FLU3~CONNAUGHT LABORATORIES~5J61007~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0078954	11/14/1995	NY	52.0			M	11/07/1995	4 full days hardly any sleep, h/a's, loose stomach-arm still hurt p/days;									Y					PUB	UNK		NONE	NONE	~ ()~~~In patient	NYS96044	1						1	Gastrointestinal disorder; Headache; Insomnia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078955	11/14/1995	NC	43.0	42		F	11/07/1995	myalgia-local w/high fever, severe rt shoulder pain (deltodi) rt axillary adenopathy-no systems sx-resolving over several days									Y	11/03/1995	11/05/1995	2	NONE	PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Lymphadenopathy; Myalgia; Pain; Pyrexia	FLU3~PFIZER\WYETH~4958129~5~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078956	11/14/1995	GA	0.8	0	.8	F	11/03/1995	pt recvd flu shot 27OCT95 lt arm has been sore; noted occasional itching 2NOV lt upper arm & 3NOV lt arm red & itchy									Y	10/27/1995	11/03/1995	7		PVT	OTH	NONE	NONE	sulfa-prob Thimersol	pt exp rxn in 1987 w/HB vax dose 3~ ()~~~In patient		1						1	Myalgia; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078957	11/14/1995	NC	46.0	46		F	11/08/1995	6NOV95 flu vax given immed rxn @ site finger size welt @ site which inc to nickle size;pt took DPH;7NOV95 area warm, red & swollen, seize of quarter;18NOV area red, swollen, warm & dark red area to center 2 1/2inches x 4 inches in diameter									Y	11/06/1995	11/06/1995	0	NONE	PVT	PVT	Verapmil	NONE	NKDA, HTN	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site reaction; Skin nodule; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4958228~4~IM~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078958	11/14/1995	CA	29.0	29		F	11/07/1995	faint reddness to sides of face, blotch to lt cheek & scattered lacy pink/red rash to upper chest;occured 1hr 45mins p/vax;tx w/DPH;rash resolved w/in an hr									Y	11/01/1995	11/01/1995	0	NA	OTH	PUB	o/c's	NONE	chronic sinusitis	NA~ ()~~~In patient		1						1	Rash maculo-papular; Vasodilatation	FLU3~PFIZER\WYETH~4958151~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078959	11/14/1995	VA	23.0	23		F	11/09/1995	rt eye-lid became red & swollen 24hrsp/vax;still swollen 2 days p/vax steadily decreasing in edema									Y	11/07/1995	11/08/1995	1	NONE	OTH	UNK	NONE	NONE	allergy to morphine-n/v, DTP as infant eyes swollen	pt exp eyes swollen w/DTP vax a/age 5 unk dose~ ()~~~In patient		1						1	Face oedema; Vasodilatation	FLU3~PFIZER\WYETH~5F6115~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078964	11/14/1995	NY	66.0	66		F	11/06/1995	morning p/shot had itch @ site of shot, very hot & red patch size of a silver dollar;applied cold compress several times a day									Y	10/26/1995	10/27/1995	1		OTH	PUB	Claritin		PCN? Sulphur?	pt exp rxn @ 65yrs w/flu vax dose 1~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078966	11/14/1995	FL	45.0	45		F		2 round red bump @ inj site itched alot & was very hot to touch;									Y	11/17/1995	11/20/1995	3	NONE	PVT	PVT	Altace	NONE	high blood pressure	NONE~ ()~~~In patient		1						1	Injection site reaction; Pruritus; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079036	11/15/1995	NY	81.0	81		F	11/15/1995	pt devel full-blown flu sxs w/in 4 days of flu shot;This is the 7-8 patient to tell MD of same story; sick for 3 wks Med bill > 100.00			Y						U	10/28/1995				PUB	PUB		NONE	HTN	~ ()~~~In patient		1						1	Influenza; Influenza	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening	Influenza
0079038	11/15/1995	TX	61.0			F	11/09/1995	lt lower quad pain-devel GBS-ER intubation has not regained motor strength or movement-flacid paralysis			Y	Y	Y			Y	N	10/20/1995	10/24/1995	4	NA	MIL	MIL	NONE	NONE	NONE	unk~ ()~~~In patient		1						1	Abdominal pain; Guillain-Barre syndrome; Hypokinesia; Paralysis flaccid; Guillain-Barre syndrome; Abdominal pain; Apnoea; Infection; Leukocytosis; Myasthenic syndrome; Neuropathy; Paralysis	FLU3~CONNAUGHT LABORATORIES~5J61010~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~5J61010~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~5J61010~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0079052	11/15/1995	NY	48.0	47		F	11/09/1995	periods of confusion, dizziness, transient tingling of lt fingers on 3NOV95-9NOV95 SOB, dec BP, noc sweats, inc WBC, diarrhea, low grade fever especially since 3NOV95; MD told pt has some type of viral infect-prob secondary to vax				Y					U	11/02/1995	11/02/1995	0		OTH	PVT	UNK	NONE	UNK	UNK~ ()~~~In patient		1						1	Confusional state; Drug ineffective; Dyspnoea; Hypotension; Infection; Influenza; Leukocytosis; Paraesthesia	FLU3~PARKE-DAVIS~01495P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0079053	11/15/1995	CA	73.0	73		F		pt recvd vax & rt arm sore & swelling; 20OCT had fever 100.3 & arm more sore;21OCT had same fever arm more swollen & sore;22OCT woke up sweat drenched;bed & pillow wet-night gown wet;arm red, hot (very hot) & hard;heart raced w/sl exertion;				Y					U	10/19/1995	10/19/1995	0	PB 166/90	PUB	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Hypokinesia; Hypotension; Myalgia; Oedema peripheral; Pyrexia; Skin nodule; Tachycardia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0079056	11/15/1995	IN	20.0			F	11/07/1995	pt to ER w/bright red spots, pruritus, itchy, resp rate 20; recvd flu vax 0700 that day; no unusual diet, chemical exposures; took usual dose of contraceptive in AM, ? single cold capsule; dx allerg rxn of ? etiol; ? flu vax relationship										11/02/1995	11/02/1995	0		UNK	UNK	NONE		neg for allergies	~ ()~~~In patient		1						1	Hypersensitivity; Pruritus; Rash; Tachycardia	FLU3~PFIZER\WYETH~4958112~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079057	11/15/1995	MN				U	11/03/1995	gen rash p/inj required oral DPH to control; 2 pts were treated for rash p/mass vax of 400 employees;rash was reported hrs p/vax on 27NOV95;										10/27/1995				UNK	UNK				~ ()~~~In patient		1						1	Rash	FLU3~PFIZER\WYETH~4958112~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079058	11/15/1995	MD	48.0			F	10/27/1995	induration w/exfoliation lt deltoid area; following flu shot;induration  = 60mm x 40mm											10/26/1995		NA	UNK	UNK			Thimerasol allergy	~ ()~~~In patient		1						1	Dermatitis exfoliative; Skin nodule	FLU3~PFIZER\WYETH~4958138~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079059	11/15/1995	NC	78.0	78		M	11/03/1995	6OCT95 burning pain w/weakness both thigh;difficult ambulation-fell x 2 used a cane;7OCT95 started Pred dose pak & noted relief in burning sensation by next day, but weakness cont;saw MD 12OCT95 CBC, TSH, Theophyllin & SMA12 WNL;poss GBS									N	10/06/1995	10/06/1995	0	NA	PUB	PUB	Theodur, Voltaren, Zantac, Centrum, Synthroid, Thiazide, APAP, Darvocet	NONE	allergies-grass, trees, molds, dust,morphine, furadentin, percocet;sleep apnea x 4yrs; sleep clinic @ kuke, uses CPAP @ nov	NONE~ ()~~~In patient	NC95118	1						1	Asthenia; Guillain-Barre syndrome; Hypokinesia; Myasthenic syndrome; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4958073~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079060	11/15/1995	OH	40.0	40		F	11/01/1995	pt recvd vax 250PM 26OCT95 & 7PM-730PM severe back & joint pain, h/a, chills, fever;1145PM stiff neck, backache;27OCT95 red rash, (disappeared in 24hrs), palms of hands red, skin felt like sandpaper, t104 w/chills, severe nausea;										10/26/1995	10/26/1995	0		UNK	UNK			allergies PCN, ASA, Darvocet, Codeine, IVP dye, tetanus toxoid; hx of pneumonia 7 asthmatic bronchitis in past several yrs, chronic epstein-Barr virus	pt exp rxn 1967 w/flu vax inc temp, rash, projective vomiting x 3 days~ ()~~~In patient		1						1	Arthralgia; Back pain; Chills; Headache; Hypertonia; Nausea; Pyrexia; Rash	FLU3~PFIZER\WYETH~4958078~UNK~SC~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079063	11/15/1995	TX	32.0			F	10/31/1995	pt recvd vax inadvertently SQ instead of IM & exp dermatological effects (redness, warmth, swelling to inj site) which subsided p/3-4 days;day p/vax pt saw MD & Augmentin given for poss infect				Y						10/09/1995	10/10/1995	1	NA	UNK	UNK	NA		NKA	~ ()~~~In patient		1						1	Infection; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61021~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0079064	11/15/1995	TX	41.0			F	10/31/1995	pt recvd flu vax inadvertently administered SQ instead of IM & pt exp dermatological effects only (rednes, warmth & swelling to inj site) which subsided p/3-4 days;no intervention by MD prescribed; pt able to obtain relief from oral NSAID										10/09/1995	10/10/1995	1		UNK	UNK	NA		NKA	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61021~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079065	11/15/1995	TX	42.0			F	10/31/1995	pt was inadvertently given SQ instead of IM vax & exp dermatological effects only (redness, warmth & swelling) to face & inj site; these effects subsided p/3-4 days; no medical intervention was sought for tx w/prescription med;										10/09/1995	10/10/1995	1	NA	UNK	UNK	NA		NKA	~ ()~~~In patient		1						1	Face oedema; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~5F61021~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079068	11/15/1995	AR	51.0	51		M	11/07/1995	5 days p/vax devel severe h/a, fever, chills, aching, nasal drainage;following 2 days sore throat, lymph, t101 currently sore throat, low grade temp									U	10/29/1995	11/03/1995	5		PVT	PVT	ASA;Claritin, Chlortrimeton, Librax, Tavist D, Nasalade spray PRN	NONE	resp allergies	~ ()~~~In patient		1						1	Chills; Headache; Lymphadenopathy; Myalgia; Pharyngitis; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61006~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079072	11/15/1995	NJ				F	11/09/1995	pt states 930AM 9NOV95 devel soreness lt deltoid inj site (pneumonia vax) approx 2hrs p/inj;has become progressively more swollen & warm to the touch w/tenderness;more swelling & tenderness below inj site to elbow;									Y	11/08/1995	11/08/1995	0	NONE	PVT	PVT	Lanoxin, Inderal & Coumadin, Vitamins	NONE	Codeine	NONE~ ()~~~In patient		1						1	Injection site pain; Oedema peripheral; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4958109~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~428501~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0079073	11/15/1995	AZ	81.0	81		F	11/09/1995	fluzone given 24OCT95 tightness in chest & cough 27OCT progressed to diarrhea on 30OCT95; gradually resolved;APAP PRN									Y	10/24/1995	10/27/1995	3	NONE	PVT	PVT	Zestril, Relafen, Glucatrol, Betamothasome	recovering from UTI	PCN, Sulfa	~ ()~~~In patient		1						1	Chest pain; Cough; Diarrhoea	FLU3~CONNAUGHT LABORATORIES~5F61114~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079078	11/15/1995	IN	63.0	62		F		pt recvd vax 17OCT95 to report that 13OCT95 pt lt arm was swollen, had some rash & was warm to touch;said it involved upper arm to elbow said it was better (less swollen & hot) 17NOV95;									Y	10/12/1995	11/13/1995	32	NA	PUB	PUB		NONE		unk~ ()~~~In patient		1						1	Oedema peripheral; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4958150~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079079	11/15/1995	NJ	11.0	11		M	11/13/1995	itchy erythema & induration 7cm diameter around inj in lt leg;									Y	11/12/1995	11/12/1995	0	NONE	PVT	PVT	Insulin	NONE	diabetes mellitus	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Pruritus	FLU3~MEDEVA PHARMA, LTD.~E2715~1~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0079080	11/15/1995	NJ	8.0	8		M	11/13/1995	hives on trunk 3hrs p/inj									Y	11/13/1995	11/13/1995	0	NONE	PVT	PVT	Tranxene	NONE	cerebral palsy	NONE~ ()~~~In patient		1						1	Urticaria	FLU3~MEDEVA PHARMA, LTD.~E2715~1~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0079082	11/15/1995	CT	38.0	38		F	11/09/1995	lt arm pain in upper arm began a few hrs p/inj;pain did not subside;4NOV95 onset of gen malaise, arthralgias;devel fever 101 5NOV & 6NOV;h/a, mild sinus congestion, sore throat, weakness x 3days;total duration of illness x 5 days;									N	10/27/1995	10/27/1995	0	NONE	OTH	PVT	NONE	NONE	NONE	pt exp fever & chills x 48hrs @ 37yrs old w/flu vax dose 1~ ()~~~In patient		1						1	Arthralgia; Asthenia; Headache; Malaise; Pain; Pharyngitis; Pyrexia; Sinusitis	FLU3~MEDEVA PHARMA, LTD.~E2745HC~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0079084	11/15/1995	CA	69.0	69		F	11/10/1995	immed deltoid pain @ time of inj-has sense radiated & cont to involve lt deltoid-pain persists 3wks				Y					N	10/14/1995	10/15/1995	1	NONE	PVT	PVT	Premarin, Prevara, Motrin	NONE	Aspirin, Dolibid-Othro arthritis	NONE~ ()~~~In patient		1						1	Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0079085	11/15/1995	TX	51.0	51		F	11/14/1995	arm from shoulder to hand, aching severely-could not use or raise arm				Y					U	11/06/1995	11/11/1995	5	NONE	OTH	OTH	Vasotex, Lpiex	NONE	PCN, arteria by-pass (legs)	NONE~ ()~~~In patient		1						1	Hypokinesia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0079089	11/15/1995	IA	35.0	35		F	11/10/1995	broke out in rash & hives (entire body), body temp, eyes & ears swell-ears felt like full of hot wax-very warm									N	11/08/1995	11/09/1995	1	NONE	OTH	OTH	NONE	sore throat	NONE	~ ()~~~In patient		1						1	Face oedema; Pyrexia; Rash; Urticaria; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079092	11/15/1995	MD	62.0	62		F	11/09/1995	starting vomiting @ 3PM during noc had fever 100 next day broke out in hives all over fever 102 starting Sunday sick until Wednesday feeling OK Thursday p/4days;									Y	11/03/1995	11/05/1995	2		PUB	UNK	Cardizem, Prempro	NONE		~ ()~~~In patient	MD95048	1						1	Malaise; Pyrexia; Urticaria; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079093	11/15/1995	MD	73.0	73		M	11/09/1995	arm swollen from site of inj down to fingers tips; red & warm to touch									Y	10/17/1995	10/18/1995	1	NA	PUB	PUB	Pt recvd flu vax in 1994 by Connaught lot# 5F61120	NONE	NONE	~ ()~~~In patient	MD95049	1						1	Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61120~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0962A~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0079094	11/15/1995	ID	77.0	76		F	11/01/1995	arm itched-on 28OCT95;arm swollen deltoid to elbow, beet red;28OCT95 went to ER, rx DPH, cold pack, Biaxin;one big lump some itching;problems is one inch below inj				Y					Y	10/26/1995	10/28/1995	2	NONE	OTH	PUB	Cardene	NONE	HTN	NONE~ ()~~~In patient	ID95064	1						1	Oedema peripheral; Pruritus; Skin nodule; Vasodilatation	FLU3~PFIZER\WYETH~4958139~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0079116	11/15/1995	MN	46.0	46		F	11/09/1995	approx 30hrs p/vax arm of inj became puffy, red, painful & then broke out in hives-2 to 3 days-body aches (24 hrs), h/a, unable to work;									Y	11/03/1995			NONE	PVT	OTH	Welbuterin	NONE	NONE	NONE~ ()~~~In patient		1						1	Headache; Myalgia; Oedema peripheral; Pain; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~5F61014~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0078979	11/16/1995	CA	9.0	9		F	11/10/1995	had sz-like activity 24hrs p/vax;also has family hx of epilepsy				Y					Y	10/23/1995	10/24/1995	1	EEG pending; CBC, chemistries nl	PVT	OTH	asthma medications	NONE	asthma	~ ()~~~In patient		1						1	Convulsion	FLU3~PFIZER\WYETH~4958117~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0078981	11/16/1995	WI	44.0	44		F	11/01/1995	devel  rash/hives, congestion & bronchial spasms;rx w/Epi inhaler, steroids & DPH in ER				Y					Y	10/18/1995	10/18/1995	0		OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Asthma; Rash; Rhinitis; Urticaria	FLU3~CONNAUGHT LABORATORIES~5F61012~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0078982	11/16/1995	MD	37.0	37		M	10/24/1995	swollen arm, red, fever T104, severe arm discomfort, hot dizziness, T100.8 on 23OCT95;Tetracycline started 22OCT95				Y					U	10/20/1995	10/20/1995	0		OTH	OTH	NONE			NONE~ ()~~~In patient		1						1	Dizziness; Oedema peripheral; Pain; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61167~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1076B~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0078983	11/16/1995	OH	30.0	30		F	10/20/1995	14OCT strange feeling in throat started & cont;18OCT lips became edematous & wheezing started;has the sensation of a large lump in throat w/gen pruritus;21OCT hands & feet became swollen, painful & fire red;23OCT gen rash devel w/pruritus				Y					Y	10/12/1995	10/14/1995	2	NONE	PUB	OTH	Theodur;Proventil inhaler	NONE	asthma, as a child tested positive for a mild allergy to eggs;eats eggs frequently w/no side effects	pt exp same as above rxn @ 29yrs w/flu vax #1;~ ()~~~In patient		1						1	Asthma; Face oedema; Laryngospasm; Oedema peripheral; Pain; Pruritus; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4958137~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0078986	11/16/1995	GA	48.0	48		F	10/26/1995	pt had pain in lt upper arm beginning in the afternoon p/shot;when the shot was given there was no bleeding observed;pt devel bruising of upper lt arm along w/inc pain;pt did not improve & saw MD;MD felt was rxn to flu vax;pt given Ceclor				Y					Y	10/13/1995	10/13/1995	0		PUB	PUB	Asthma medication	NONE	asthma	~ ()~~~In patient	GA95183	1						1	Ecchymosis; Injection site pain; Pain	FLU3~PFIZER\WYETH~4958123~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0078989	11/16/1995	GA	20.0	20		F	10/16/1995	c/o pain, swelling & redness of arm where vax given;pneumovax given in other deltoid w/no problems; c/o t102;				Y					Y	10/02/1995	10/04/1995	2		PUB	PUB	AZT	HIV pos	HIV pos	~ ()~~~In patient	GA95175	1						1	Infection; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia	FLU3~PFIZER\WYETH~4958123~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1558A~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0078991	11/16/1995	GA	8.0	8		F	10/06/1995	3OCT95 pt recvd vax & 2OCT pt has broken in large welts on back each evening & temp as high as 103;mom states it was the pts 3rd Hep B vax & the pt had no problems w/1st shot;referred to MD				Y					U	10/03/1995	10/03/1995	0	NA	PUB	PUB	NONE	NONE	NKA	NONE~ ()~~~In patient	GA95169	1						1	Pyrexia; Urticaria	FLU3~PARKE-DAVIS~00985P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~MERCK & CO. INC.~0213A~3~IM~RA~HEP B (RECOMBIVAX HB)~1	USA	Emergency room visit	Influenza
0078992	11/16/1995	GA	22.0	22		F	10/06/1995	3OCT95 pt recvd vax & began that afternoon w/mosquito bite size red area; continually getting larger-today 2 1/2inches by 3inches;tender to touch-even to clothes;temp up to 101 nightly since inject;referred to MD				Y					U	10/03/1995	10/03/1995	0	NA	PUB	PUB	NONE	NONE	x-ray dye	NONE~ ()~~~In patient	GA95170	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia	FLU3~PARKE-DAVIS~00985P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~380955~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0079001	11/16/1995	TX	45.0	45		F	11/13/1995	7hrs p/vax acute onset of sneezing, wheezing, angioedema & itching of face & throat, hoarseness;responded slowly to ventolin inhaler & DPH									Y	11/06/1995	11/06/1995	0		PVT	PVT	Ventolin inhaler, Tilade	NONE	asthma	~ ()~~~In patient		1						1	Angioneurotic oedema; Asthma; Laryngospasm; Pruritus; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61014~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079004	11/16/1995	PA	60.0	60		F	11/08/1995	pt reports never so sick in my life 11 days p/receiving flu vax;nausea, vomiting, dizziness, too weak to get out of bed for 1 day;did not go to any health care provider recovered over next 4 days									Y	10/18/1995	10/29/1995	11	NONE	OTH	PUB	NONE	NNE	NONE	~ ()~~~In patient		1						1	Asthenia; Dizziness; Malaise; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~5F61145~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079008	11/16/1995	GA	67.0	66		M	10/26/1995	started hurting last noc could not lie on last PM; c/o soreness, itching (rt arm); reddness starting on deltoid goes down arm to biceps-blistery-swollen-warm to touch									Y	10/25/1995	10/25/1995	0	NONE	PUB	PUB		NONE	NONE	NONE~ ()~~~In patient	GA95182	1						1	Dermatitis bullous; Injection site hypersensitivity; Oedema; Pain; Pruritus; Skin striae; Vasodilatation	FLU3~PARKE-DAVIS~01595~7+~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~428003~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0079009	11/16/1995	GA	60.0	60		F	10/20/1995	20OCT95 pt came in for eval of local rxn to lt arm had flu shot yesterday) area appeared approx fifty cents piece size red & somewhat swollen;no itching or fever noted;									Y	10/17/1995	10/17/1995	0	NA	PUB	PUB	allergy shot	NONE	allergies takes medication	NA~ ()~~~In patient	GA95180	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PARKE-DAVIS~01185P~6~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0079011	11/16/1995	GA	66.0	66		M	10/15/1995	swelling & aching lt arm from elbow to inj site; began approx 1 hr p/inj; instructed to elevate & put ice on area; if no improvement to go to ER									Y	10/14/1995	10/14/1995	0		PUB	PUB	Lanoxin, Calan	NONE	NONE	~ ()~~~In patient	GA95174	1						1	Injection site oedema; Injection site pain; Oedema; Pain	FLU3~PFIZER\WYETH~4958114~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~428493~1~IM~LA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~5B71048~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0079012	11/16/1995	GA	43.0	43		M	10/13/1995	pt recvd vax 11OCT95 240PM & 12OCT95 lump/hive just below rt elbow;as the day progressed pt states the hives spread;pt states nauseous & cold;13OCT95 lt hand swollen & red splotches on bilat forearms;									Y	10/11/1995	10/12/1995	1	NONE	PUB	PUB	Cefzil	sinus infection	NONE	NA~ ()~~~In patient	GA95173	1						1	Chills; Nausea; Oedema peripheral; Rash maculo-papular; Urticaria	FLU3~PARKE-DAVIS~01185P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0079016	11/16/1995	MA	38.0	38		F	11/06/1995	pt recvd vax 27OCT95 1030AM & 2:30 chills/dizziness by PM feverish/achy/chills-sore throat cold a/29OCT AM;									Y	10/27/1995	10/27/1995	0	NONE	PUB	PUB		NONE	just allergy to amoxicillin & sulfa drugs	~ ()~~~In patient	MA9520	1						1	Chills; Dizziness; Myalgia; Pharyngitis; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61134~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079017	11/16/1995	MA	67.0	67		F	11/06/1995	6NOV95 stiff neck unchanged; no treatment; pt states was working @ health fair 29OCT95 outside in rain & wind feels neck strain & could be related to working not vax									Y	10/28/1995	10/30/1995	2		PUB	PUB				~ ()~~~In patient	MA9519	1						1	Nuchal rigidity	FLU3~CONNAUGHT LABORATORIES~5F61134~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079018	11/16/1995	MA	60.0	59		F	11/03/1995	husband reported to BOH on 3NOV95: 2hrs p/vax coughing, chills, muscle aches, fever 102, h/a, nausea, diarrhea; bedrest-no medication taken;these sxs lasted approx 24hrs;									Y	11/02/1995	11/02/1995	0	NA	UNK	UNK	Provera, Cardizem, Bufferin as ordered	NA	NA	~ ()~~~In patient	MA9518	1						1	Chills; Cough; Diarrhoea; Headache; Myalgia; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61134~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079019	11/16/1995	MA	31.0	31		F	11/03/1995	inj site became red & swollen approx 1 1/2 diameter, low grade temp, hives over buttocks & back of legs last 4 days;									Y	10/17/1995	10/17/1995	0		OTH	PUB	Birth control pills	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pyrexia; Urticaria	FLU3~CONNAUGHT LABORATORIES~5F61134~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079020	11/16/1995	PA	55.0	55		F	10/17/1995	12OCT chills, t101 & vomiting throughout noc									Y	10/12/1995	10/12/1995	0		PVT	OTH	NONE	NONE	has thyroid condition	NONE~ ()~~~In patient		1						1	Chills; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~00575P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0079021	11/16/1995	PA	44.0	44		F	10/16/1995	15OCT itchy eyes & upon arising this AM pt took DPH 1/2hr;									U	10/11/1995	10/15/1995	4	NONE	PVT	OTH	NONE	NONE	has had allergies to trees in past	NONE~ ()~~~In patient		1						1	Conjunctivitis	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079022	11/16/1995	PA	40.0	40		F		fever 101-102 & emesis 12 hrs p/vax;duration 2 days; also myalgias, arthralgia; pt has hx SLE, no recent flares;									U	10/11/1995	10/12/1995	1		PVT	OTH	Plaquirol, Synthroid, Calan, phenobarb acthylchlorthiazide	SLE no recen flares	allergies PCN (fever, hives); SLE	pt exp fever, joint pain, n,v @ 39yrs old w/MMR SEP94 booster~ ()~~~In patient		1						1	Arthralgia; Myalgia; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078639	11/17/1995	WA	33.0	32		F	09/28/1995	diarrhea, h/a, rash, tightness of chest rx w/DPH				Y					Y	09/25/1995	09/25/1995	0		OTH	PVT	NONE	nONE	allergic to parrots	NONE~ ()~~~In patient		1						2	Chest pain; Diarrhoea; Headache; Rash; Chest pain; Diarrhoea; Headache; Rash	FLU3~CONNAUGHT LABORATORIES~5G1166~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~5H71142~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0079097	11/17/1995	NJ	44.0	43		F	11/15/1995	sore throat & chest congestion, sore arm for a few days;sneezing, runny nose, no fever;									Y	11/09/1995	11/10/1995	1	NONE	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Lung disorder; Pain; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61014~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079098	11/17/1995	WA	41.0	41		F	11/02/1995	pt recvd vax & next AM devel raised rash bilat sides from underarm to hips; sl itching; rx DPH									U	11/01/1995	11/02/1995	1		OTH	OTH			allergy to sulfur drug	NONE~ ()~~~In patient		1						1	Pruritus; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079099	11/17/1995	NC	37.0	37		M	10/20/1995	reports recvd vax Monday & arm bruised, pain & swelling from shoulder to elbow;now pain radiating down arm;fingers cold & numb; referred pt to ER										10/16/1995	10/20/1995	4		OTH	UNK	No meds		NONE	NONE~ ()~~~In patient		1						1	Chills; Ecchymosis; Oedema; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~5F61166~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079101	11/17/1995	WA	57.0	57		F	10/18/1995	6OCT Friday eve T101, aches & pains, swelling lt arm elbow & up into back-area warm to touch lasted through;Sunday no sxs on Monday 9OCT fine rash on stomach, arms & legs;									Y	10/06/1995	10/06/1995	0		PUB	PUB	Premarin-Provera	1wk prior-sore throat	dogs, cats, pollen, trees, dust, grass-on allergy shots q 3 wks had not had for 3wks prior to pneumovax & fl vax	~ ()~~~In patient	WA951172	1						1	Injection site oedema; Myalgia; Oedema; Pyrexia; Rash; Vasodilatation	FLU3~PARKE-DAVIS~01085P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~380955~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0079102	11/17/1995	WA	35.0	34		F	10/23/1995	2x3cm indurated in area of inj;no drainage @ site of inj on 21OCT95;On 23OCT95-flat & not red									Y	10/20/1995	10/20/1995	0		PUB	PUB				~ ()~~~In patient	WA951173	1						1	Injection site mass	FLU3~CONNAUGHT LABORATORIES~5J61007~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079103	11/17/1995	WA	52.0	52		F	10/20/1995	pt recvd vax 16OCT95 & woke 20OCT95 w/red rash rough on face, neck; no fever, illness sx;eyes puffy;no known new allergens;advised to see MD to determine cause; started clearing up 21OCT-did not to to MD									Y	10/16/1995	10/20/1995	4		PUB	UNK	Hormones	NONE	NONE	NONE~ ()~~~In patient	WA951175	1						1	Face oedema; Rash maculo-papular	FLU3~PFIZER\WYETH~4958139~3~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079104	11/17/1995	WA	40.0	40		F	10/30/1995	7PM-had coughing fit from deep inside; got home, relaxed;face got red, not hot; eyes felt like sand in them really dry; sweating but chilled & hot; chest felt tight/breathless/shallow;arm real sore; states took APAP q 3hrs;tightness in ches									Y	11/14/1994	11/14/1994	0	NONE	PUB	PUB	unk	NONE	unk	NONE~ ()~~~In patient	WA951176	1						1	Chest pain; Chills; Conjunctivitis; Cough; Dyspnoea; Hyperhidrosis; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51024~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079105	11/17/1995	WA	51.0	51		F	10/30/1995	1-2 days p/vax high fever & sore throat, also several bouts of diarrhea;									Y	10/26/1994	10/27/1994	1	NONE	PUB	PUB	unk	NONE	unk	~ ()~~~In patient	WA951177	1						1	Diarrhoea; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51024~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079108	11/17/1995	TN	45.0	45		M	11/01/1995	lt deltoid area-red swollen, irritated, warm to touch;									Y	10/25/1995	10/28/1995	3	NONE	PUB	PUB	NONE	accident-suture rt index finger	NONE	pt exp red swollen, hot to touch, streaking @ 45yrs w/TD~ ()~~~In patient	TN95113	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61119~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079109	11/17/1995	TN	27.0	27		F	11/01/1995	joint pain & swelling starting 30OCT95 PM									U	10/30/1995	10/30/1995	0		PUB	PUB	on 7-7-7	NONE		~ ()~~~In patient	TN95114	1						1	Arthralgia; Osteoarthritis	FLU3~CONNAUGHT LABORATORIES~5F61120~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079110	11/17/1995	PA	39.0	39		F	10/30/1995	devel rt arm pain & stiffness about 1/2hr p/vax; had pain from neck downn  to hand especially w/movement of shoulder;seen by MD: given Advil;sxs subsided over several days				Y						10/23/1995			NONE	PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Hypertonia; Pain	FLU3~PFIZER\WYETH~4958068~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0079112	11/17/1995	TX	12.0	12		M	10/27/1995	devel raised lumps on wrist 24hrs p/vax, no itching, 48hrs p/spread to chest & others areas;DPH, Cativate cream no relief				Y					U	10/16/1995	10/17/1995	1	dx allergies rx vs poison ivy	OTH	OTH	APAP, DPH	NONE	asthma	pt's sibling exp rxn @ 18mos w/MMR~ ()~~~In Sibling		1						1	Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~5F61166~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0079113	11/17/1995	WA	48.0	48		F	10/23/1995	exp diff breathing 12hrs p/shot; called 911-BP inc; given 02 taken to ER;had no asthma x 12 yrs;				Y					Y	10/20/1995	10/20/1995	0	NONE	PVT	PVT	Hychlororioside; KCL tab; Enalapril	NONE	HTN; asthma dx 1983	NONE~ ()~~~In patient	WA951178	1						1	Dyspnoea; Hypertension	FLU3~PFIZER\WYETH~4958126~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0079114	11/17/1995	WA	68.0	68		M	10/10/1995	pt recvd vax 3OCT95;10OCT95 pt came to the clinic & reported that on 4OCT lt arm was real sore & 3 fingers were numb; went to PMD & was told the inj was given close to a nerve;				Y						10/03/1995	10/04/1995	1		PUB	PVT				~ ()~~~In patient	WA951174	1						1	Injection site pain; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4958117~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0055821	11/20/1995	MI				M	11/01/1995	pt recvd vax 5OCT92 & alleges that devel acute transverse myelitis which resulted in residual neuro deficit, spastic asymmetric digplegic gait, prominent posterior column involvement, sensory impairment, motor dysfunction, gait DO, paresis								Y	N	10/05/1992				OTH	OTH	unk	unk		~ ()~~~In patient	895310005L	1						2	Asthenia; Coordination abnormal; Gait disturbance; Myelitis; Neuropathy; Paraesthesia; Paralysis	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Disabling	Influenza
0079038	11/20/1995	TX	61.0			F	11/16/1995	devel GBS between 24-26th of OCtober which has required mechanical ventilation;still paralysed x/for eye movements;treated w/plasmaphorisis w/o improvement;Will do series og IGG treatments;healthy prior w/no medical problems;			Y		Y				N	10/20/1995	10/24/1995	4		MIL	MIL	NONE		No prior medical history	~ ()~~~In patient	CO6314	1						2	Abdominal pain; Guillain-Barre syndrome; Hypokinesia; Paralysis flaccid; Guillain-Barre syndrome; Abdominal pain; Apnoea; Infection; Leukocytosis; Myasthenic syndrome; Neuropathy; Paralysis	FLU3~CONNAUGHT LABORATORIES~5J61010~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~5J61010~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~5J61010~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Life Threatening,Hospitalisation	Influenza
0079249	11/20/1995	NH				F	11/09/1995	Guillain Barre synd. the pt recvd flu vax 93-94 formula on 5Nov93, subseqently pt developed GBS and was hospitalized for tx in Jan94. This ia a serious labelled event.					Y				U	11/05/1993	11/05/1993	0		PVT	PVT	unk	unk		~ ()~~~In patient	895314006L	1						1	Guillain-Barre syndrome	FLUX~PFIZER\WYETH~4938119~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0079254	11/20/1995	OR	25.0			M	10/31/1995	pt recvd flu vax 10OCT95 & reported pt is hospitalized in ICU w/dx of GBS;No further details known as of the date of this report;					Y				N	10/10/1995				OTH	OTH	unk	unk		~ ()~~~In patient	895307005S	1						1	Guillain-Barre syndrome; Infection; Meningitis; Neuropathy; Paralysis; Urinary retention	FLU3~PFIZER\WYETH~4958126~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0079255	11/20/1995	IL	60.0	60		F		onset 3wks later of ascending weakness & paralysis;GBS symptoms;					Y	21			U	10/10/1995	10/28/1995	18		PVT	PVT	Ceftin	recent pharyngitis 21SEP95	NONE	NONE~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome; Paralysis	FLU3~PARKE-DAVIS~000875P~1~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0079256	11/20/1995	PA	18.0	18		F	11/16/1995	tightness in chest, wheezing 4hrs p/vax; no local rxn;seen in ER & treated w/EP & released; sxs reoccurred & was adm to hosp 31OCT95;stable & expected d/c 3NOV95					Y	3			Y	10/30/1995	10/30/1995	0		OTH	OTH			no past hx of allergy, some type of eye problems & sinusitis	~ ()~~~In patient	CO6292	1						1	Asthma; Chest pain	FLU3~CONNAUGHT LABORATORIES~5F61133~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0079257	11/20/1995	CA	60.0	60		M	11/03/1995	pt recvd vax 7OCT95 & 8OCT95 pt devel a low grade fever & the following day numbness of the feet & chest, dec resp & a rash on onse side of the rib cage; pt was admitted 9OCT95 to hosp tx IV's  & released;exp vertigo after hospital stay.					Y	2			Y	10/07/1995	10/08/1995	1		OTH	OTH	unk	unk		~ ()~~~In patient	895312003L	1						1	Hyporeflexia; Hypoventilation; Myasthenic syndrome; Neuritis; Paraesthesia; Pyrexia; Rash; Vertigo	FLU3~PFIZER\WYETH~4958122~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0079260	11/20/1995	FL	75.0	75		M	10/18/1995	heart attack, ate dinner, rode bike on 16OCT95 p/vax; aching & diff sleeping noc of 16OCT95;sz on 17OCT95 to ER per ambulance	Y	10/17/1995							N	10/16/1995	10/17/1995	1	died @  heart of Florida hosp	PUB	PUB		NONE	NONE	~ ()~~~In patient	FL95079	1						1	Cardiovascular disorder; Convulsion; Insomnia; Pain	FLU3~CONNAUGHT LABORATORIES~5F61148~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~390968~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Results in Death	Influenza
0079268	11/20/1995	MO	27.0	27		F	11/13/1995	612PM flu vax given rt rm pt described a burning flash from arm to heas felt head would explode;extremely dizzy, apprehension, sweaty, cold, fading feeling pt stated something wrong; need to go to hosp;paleness, tem loss of consciousness;				Y					Y	11/10/1995	11/10/1995	0	NA	OTH	PVT	unk	NONE	mitral valve & thyroid conditions	NONE~ ()~~~In patient		1						1	Anxiety; Asthma; Cardiovascular disorder; Chills; Dyspnoea; Lung disorder; Stupor; Syncope	FLU3~CONNAUGHT LABORATORIES~5F61015~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0079272	11/20/1995	GA	55.0	55		M		pt vaxed 10JAN94 & 21JAN94 c/o h/a;next morning told wife feet tingling, speech slurred,brain stem infarct;3AM on Sunday morning awoke in severe pain & asked to go to ER;exp high BP, & rapid HR;dx bells palsy;GBS,muscle weakness;resp arrest								Y	Y	01/10/1994	01/21/1994	11	BP 180/110; pulse rate 116; state of hypertonia;palpation of the posterior cervical articular processes elicited a pain reaction upon digital pressure @ the c1 & c5 level on right;x-ray's to r/o vertebral dysfunction;	PVT	PVT			HTN & diabetes mellitus	~ ()~~~In patient		1						1	Apnoea; Delirium; Guillain-Barre syndrome; Hypertension; Neuropathy; Paralysis; Speech disorder; Tachycardia	FLU3~CONNAUGHT LABORATORIES~3F41114~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0079508	11/20/1995	MN	44.0	44		F	11/16/1995	gen body itching, redness & swelling @ site 8hrs p/inj				Y					Y	10/30/1995	10/30/1995	0	NONE	PVT	OTH	NONE	NONE	back injury	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4958108~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0079509	11/20/1995	MN	39.0	39		F	11/16/1995	gen body itching reddness & swelling @ site 24 hrs p/vax				Y					Y	10/30/1995	10/31/1995	1	NONE	PVT	OTH	NONE	NONE	unk	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4958108~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0079510	11/20/1995	MN	51.0	51		F	11/16/1995	pt recvd vax & had intense pain & burning from shoulder to elbow w/numbness & tingling from elbow to fingerstipe;devel rash next morning on non-injected arm;numbeness & tingling in non-injected arm				Y					Y	10/30/1995	10/30/1995	0	NONE	PVT	OTH	unk	NONE	unk	~ ()~~~In patient		1						1	Hypoaesthesia; Pain; Paraesthesia; Rash	FLU3~PFIZER\WYETH~4958108~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0079511	11/20/1995	MN	23.0	23		F	11/16/1995	genralized itching in inj arm reddness & swelling @ inj site 48 hrs p/vax				Y					Y	10/03/1995	11/01/1995	29	NONE	PVT	OTH		NONE	unk	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~+958108~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0079515	11/20/1995	TX	61.0	61		F	11/02/1995	pt recvd vax & immed exp localized swelling & redness to site;no other c/o was noted or voiced by pt;VS BP 120/84 sitting;P80 & temp 98.4				Y					Y	11/01/1995	11/01/1995	0	NA	OTH	OTH	NONE	NONE	52 foods, pollen, ragweed & dust	NONE~ ()~~~In patient	TX95219	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~5F61168~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0079518	11/20/1995	TX	67.0	67		M	10/26/1995	pt states rt arm became sore & unable to move the arm 2 hrs p/shot given; states arm became red & swollen;states went to MD & was told had rxn to vax;told to never take flu vax again				Y					U	10/13/1995	10/13/1995	0		PUB	PUB		gum infection (?)	NKA-arthritis	~ ()~~~In patient	TX95214	1						1	Hypotonia; Oedema peripheral; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61145~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0962A~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0079520	11/20/1995	TX	51.0	51		F	10/20/1995	presented w/ c/o inability to swallow, states unable to since flu shot given earlier, noted hoarseness refer to ER-given DPH & Depomedrol; recover immed & return to clinic 40mins later;				Y					Y	10/20/1995	10/20/1995	0		PUB	PVT		NONE		~ ()~~~In patient	TX95209	1						1	Laryngitis; Laryngospasm	FLU3~CONNAUGHT LABORATORIES~5F61098~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0079521	11/20/1995	TX	40.0	40		F	10/16/1995	devel diff breathing & trachael discomfort w/in 1 hr; referred to MD who gave Decadron & Medrol dose pak				Y					Y	10/13/1995	10/13/1995	0	NONE	PUB	OTH	NONE	NONE	NKA	NA~ ()~~~In patient	TX95208	1						1	Dyspnoea; Pain	FLU3~CONNAUGHT LABORATORIES~5F61145~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0079522	11/20/1995	TX	53.0	53		F	10/16/1995	pt recvd vax 2OCT95 & 4OCT95 4cm induration size of inj inflammed-sweling size of fifty cents piece;feels warm to touch, tender to palpation				Y					Y	10/02/1995	10/04/1995	2	NONE	OTH	PUB	NONE	NONE	NA	NONE~ ()~~~In patient	TX95206	1						1	Injection site mass; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61150~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0079523	11/20/1995	TX	39.0	39		F	10/16/1995	lt upper arm 7cm swelling & erythema; pain radiating to neck & down lt arm; pt feels weak & dizzy; tx DPH;				Y					Y	10/02/1995	10/03/1995	1	NONE	OTH	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	TX95205	1						1	Asthenia; Dizziness; Oedema peripheral; Pain; Rash	FLU3~CONNAUGHT LABORATORIES~5F61150~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0079524	11/20/1995	TX	37.0	37		F	10/06/1995	erythematous, indurated, hot @ area of inj site;				Y					Y	10/04/1995	10/05/1995	1	NNE	OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	TX95204	1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61150~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0079541	11/20/1995	LA	46.0	46		F	11/13/1995	1348 weak p/vax;1350 dizzy c/o diaphoretic, pale conscious answering questions appropriately-BP 100/70, 76P, R12; 2sec nailbed capillary refill-placed supine 1355; c/o tingling of hands;  1410 BP 90/70; poss hypoglycemic attack; arm sore				Y					Y	11/13/1995	11/13/1995	0		PUB	UNK	Bronfed, Beconase inhaler, vits	NONE	environmental allergies only, asthma hx	NONE~ ()~~~In patient	LA951104	1						1	Asthenia; Dizziness; Hyperhidrosis; Hypoglycaemia; Hypotension; Pain; Pallor; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E2725HB~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TTOX~LEDERLE LABORATORIES~429310~1~IM~RA~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0079542	11/20/1995	VA	21.0			F	11/09/1995	delayed onset 1hr p/vax flushing, burning sensation, itching, hives;given Epi;no resp diff;				Y					Y	11/09/1995	11/09/1995	0	NONE	MIL	MIL	Diphenhist/elixir antihistamine	NONE	NONE	NONE~ ()~~~In patient		1						1	Pain; Pruritus; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4958207~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0079543	11/20/1995	NM	31.0	31		F	11/15/1995	pt recvd vax & noticed immed rxn of erythema @ site of inj radiating to shoulder, pt c/o pins & needles, shakiness & anxiety;gave Epi;pt c/o dizziness, numbness of extremities, clamminess;c/o tightness of throat & SOB				Y					Y	11/15/1995	11/15/1995	0	NONE	PVT	PVT	NONE	denies	reports sensitivity to medications	~ ()~~~In patient		1						1	Anxiety; Dizziness; Dyspnoea; Hypoaesthesia; Injection site hypersensitivity; Laryngospasm; Paraesthesia; Tremor; Anxiety; Dizziness; Dyspnoea; Hypoaesthesia; Injection site hypersensitivity; Laryngospasm; Paraesthesia; Tremor; Dizziness; Dyspnoea; Hyperhidrosis; Hypoaesthesia; Injection site hypersensitivity; Laryngospasm; Paraesthesia; Tremor	FLU3~PFIZER\WYETH~4958089~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4958089~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|FLU3~PFIZER\WYETH~4958089~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~3	USA	Emergency room visit	Influenza
0079543	11/20/1995	NM	31.0	31		F	11/15/1995	pt recvd vax & immed rxn of erythema to site of inj radiating to lt shoulder;pt c/o pins & needles, shakiness & anxiety;gave Epi;c/o dizziness, numbness of extremities, claminess;BP 158/64, P90, R22;taken to ER c/o tightness of throat &SOB				Y						11/15/1995	11/15/1995	0		UNK	UNK			pt denied allergies to drugs or other allergies but reports sensitivity to most medications	~ ()~~~In patient		1						3	Anxiety; Dizziness; Dyspnoea; Hypoaesthesia; Injection site hypersensitivity; Laryngospasm; Paraesthesia; Tremor; Anxiety; Dizziness; Dyspnoea; Hypoaesthesia; Injection site hypersensitivity; Laryngospasm; Paraesthesia; Tremor; Dizziness; Dyspnoea; Hyperhidrosis; Hypoaesthesia; Injection site hypersensitivity; Laryngospasm; Paraesthesia; Tremor	FLU3~PFIZER\WYETH~4958089~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4958089~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|FLU3~PFIZER\WYETH~4958089~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~3	USA	Emergency room visit	Influenza
0079549	11/20/1995	VA	72.0	72		M	10/18/1995	pt recvd vax 17OCT95 & 315PM pt @ meeting & rt side of lip became numb, then got dizzy, dropped a coke from hand; then went down on the floor; never lost consciousness;nauseated; BP elevated; mini stroke; chest problems				Y					Y	10/17/1995	10/17/1995	0	CAT scan 17OCT95 nl; EKG 17OCT95 nl	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	VA95069	1						1	Cardiovascular disorder; Cerebrovascular accident; Dizziness; Hypertension; Hypotonia; Injury; Nausea; Paraesthesia oral	FLU3~PFIZER\WYETH~4958123~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0079551	11/20/1995	VA	58.0	58		F	10/31/1995	pt started not feeling well 21OCT95 in early afternoon; By 22OCT having achiness which still cont;By first part of wk 23OCT & 24OCT started w/runny nose & congestion which still cont;unsure if ran fever;				Y					N	10/20/1995	10/21/1995	1	NONE	PUB	PUB	Premarin	NONE	hayfever-type allergies	NONE~ ()~~~In patient	VA95073	1						1	Malaise; Myalgia; Pharyngitis; Rhinitis	FLU3~PFIZER\WYETH~4958115~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0079556	11/20/1995	MN	46.0	46		F		1930 severe bronchitis like cough got worse until about 2130 then stopped abruptly;then chills, fever, nausea, diarrhea for a few hrs; by AM just h/a									Y	10/30/1995	10/30/1995	0	NONE	PUB	UNK				~ ()~~~In patient		1						1	Bronchitis; Chills; Cough; Diarrhoea; Nausea; Pyrexia	FLU3~PFIZER\WYETH~5F61014~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079557	11/20/1995	TX	43.0	43		F	11/13/1995	had h/a on 25OCt like migraine; mild h/a all wk; 27OCT severe h/a again, had vomiting in evening & all day; 28OCT by 29OCT recovering;									Y	10/23/1995	10/27/1995	4		PVT	PUB		NONE	NONE	NONE~ ()~~~In patient		1						1	Headache; Migraine; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079560	11/20/1995	CA	32.0	32		F		pt recvd vax 16OCT95 11:00 in early PM devel severe h/a cont until 11:00 17OCT95; 1wk later devel laryngitis w/moderate hearing impairment cont 14 days; also had severe arm pain, feelings of flu-like sxs;									N	10/16/1995	10/16/1995	0		UNK	UNK			h/o severe allergies currently receiving antigen injections for pollens & dust mite; h/o asthma (not on meds); breastfeeding 4 1/2 mo old	~ ()~~~In patient		1						1	Deafness; Deafness transitory; Headache; Hypersensitivity; Influenza; Laryngitis; Pain	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0079564	11/20/1995	TX	51.0	51		F	11/06/1995	pt had heaviness to both arms 1NOV95 then numbness to lt hand on 4NOV95 then numbness to rt hand on 5NOV95; on 6NOV95 pt has numbness & heaviness to both arms & hands & encouraged pt to see PMD ASAP									U	10/13/1995	11/01/1995	19		PUB	PUB	NONE	well @ time of vax	NONE	~ ()~~~In patient	TX95218	1						1	Asthenia; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~5F61168~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~5A71020~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0079572	11/20/1995	NY	62.0	62		F	10/18/1995	face swollen x 2 days, arm started puffing									Y	10/12/1995	10/13/1995	1		UNK	PVT	Relafen	NONE	sulfa allergy	~ ()~~~In patient	BA5039	1						1	Face oedema; Oedema peripheral	FLU3~PARKE-DAVIS~01285P~6~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0079576	11/20/1995	IL	79.0	79		F	11/02/1995	pt c/o pain lt arm since pt recvd vax; there is no edema, red areas or swelling then or now;advised to contact MD & report results back to the clinic									U	10/16/1995	10/17/1995	1	NONE	OTH	PUB	NONE	NONE	NONE	~ ()~~~In patient	IL950125	1						1	Pain	FLU3~CONNAUGHT LABORATORIES~5F61148~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079577	11/20/1995	FL	55.0	55		F	10/27/1995	pt recvd vax & 10mins p/vax pt noted scratching both upper arms & c/o itching @ inj site bilat; pt c/o progressive inc itching, frantic, scratching-no hives, dyspnea noted; DPH given									Y	10/26/1995	10/26/1995	0		PUB	PUB	Theo, ventolin, Albuterol syrup	c/o rt shoulder pain	by hx-PNC, ASA, EES, codeine, Demerol, NSAIDS, Quinine, Lincocin;dx COPD, ? colitis, PH-Hematoma	~ ()~~~In patient	FL95078	1						1	Dyspnoea; Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~5F61149~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~5C71114~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0079578	11/20/1995	FL	64.0	64		F	11/06/1995	w/in 5-10mins pt began to feel like could not pass air;also felt throat was swollen-later described as numb (like w/novacaine);described blurry vision; was visibly tremulous; BP sl elevated 150/85, P72 & reg;resolved in 15mins									Y	11/06/1995	11/06/1995	0	NONE	PUB	PUB	Mevacor	No current illness	allergic to demerol-Morphine;high cholesterol	NONE~ ()~~~In patient	FL95080	1						1	Amblyopia; Dyspnoea; Hypertension; Laryngospasm; Myalgia; Nausea; Paraesthesia; Tremor	FLU3~CONNAUGHT LABORATORIES~5F61095~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079581	11/20/1995	VA	25.0			F	10/13/1995	115PM pt recvd vax & was given IM lt deltoid; pt immed exp sudden warm to inj site radiating to rt hand & a fullness feeling; flat reddened area @ inj site;intermittent ice pack applied to site;DPH given;									Y					PUB	PUB	Tricyclien BCP;pt recvd PPD by connaught lot# 241111 on 29SEP95	NONE	NKA	NA~ ()~~~In patient	VA95068	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4958127~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079589	11/20/1995	IN	46.0	46		M	11/17/1995	pt started feeling bad 6NOV, 7NOV, 8NOV acute sinusitis 11NOV went to MD rx Vantin; 14NOV started feeling bad, chills, cough, phlegm, body ache, light sensitive				Y					N	11/04/1995	11/07/1995	3	Blood test (WBC)	OTH	OTH	Vasotec	NONE	HTN, (birth defect)	pt exp rxn @ 44yrs w/flu vax~ ()~~~In patient		1						1	Chills; Cough; Malaise; Myalgia; Photophobia; Sinusitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0079592	11/20/1995	CA	66.0	66		F	11/13/1995	nausea, no vomiting, felt this way on going home p/shot;intermittent h/a;nothing tastes good; no fever;for 2 wks had hives; had loose bowels day p/shot; one day only									U	10/18/1995	10/18/1995	0	NONE	PUB	PUB	Paxil	recovering from a cold while in Europe	had not started Tetracyline for Rosecea; pt takes Paxil for depression	pt exp same rxn to flu vax #1 in 1994;~ ()~~~In patient	CA95153	1						1	Diarrhoea; Dysgeusia; Headache; Nausea; Urticaria	FLU3~PFIZER\WYETH~4958138~2~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079595	11/20/1995	WY	43.0	43		F	10/20/1995	17OCT95 w/in 1 hrs of vax arm & shoulder became very painful;took Ibuprofen; ice or heat better;danger signs discussed w/ ER plans; 18OCT arm better									Y	10/17/1995	10/17/1995	0	NA	PUB	PUB			PCN allergy	~ ()~~~In patient	WY9523	1						1	Insomnia; Myalgia; Pain; Tendon disorder	FLU3~PFIZER\WYETH~4958117~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079599	11/20/1995	OH	5.0	5		F	11/06/1995	devel hives, swollen eyes & lips; 72 hrs p/vax treated w/DPH & Atarax syrup x 3 days;				Y					Y	10/30/1995	11/02/1995	3		PUB	PUB	NONE	sl runny nose	aplastic anemia s/p BMT	~ ()~~~In patient	OH95161	1						1	Face oedema; Urticaria	FLU3~PFIZER\WYETH~4958078~4~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~376969~2~IM~LL~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0082787	11/20/1995	PA	29.0	29		F	09/20/1995	severe h/a, nausea vomiting & diarrhea upon awakening;better by 11AM;no recurrence									Y	10/19/1994	10/20/1994	1		OTH	OTH	Claritin, Beconase	NONE	allergies	~ ()~~~In patient	CO5645	1						1	Diarrhoea; Headache; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51152~6~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079036	11/21/1995	NY	81.0	81		F	11/15/1995	pt devel full-blown flu sxs w/in 4 days of flu shot;this is the 7-8 pt to state same story; sick for 3wks;med bil > 100.00;			Y						U	10/28/1995				PUB	PUB		NONE	HTN	~ ()~~~In patient		1						2	Influenza; Influenza	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening	Influenza
0079473	11/21/1995	MD	74.0	74		F	11/16/1995	about 9-10 days p/vax c/o diffuse aching (myalgias), paresthesias of the hands & feet & inc weakness, unable to walk; no diff swallowing or breathing; BP inc proximal & distal BUE weakness L>R, BLE weakness L>R, reflexes dec;impression GBS					Y					10/24/1995	11/02/1995	9	CSF protein 45; IGG=1870.0 (inc); total protein & fractions WNL	PVT	PVT	Adalat, Tenormin	NONE	HTN, h/o breast CA w/rt mastectomy (18 yrs ago); abd wall sarcoma (8yrs ago)	~ ()~~~In patient		1						1	Apnoea; Guillain-Barre syndrome; Hypertension; Hypokinesia; Hyporeflexia; Myalgia; Myasthenic syndrome; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E2825HA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0079478	11/21/1995	OR	50.0	50		M	11/13/1995	It seems that a nerve may have been h it @ time of vax, triggering a painful nerve rxn from neck to fingers;				Y					Y	10/23/1995	10/26/1995	3	NONE	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Neck pain; Pain	FLU3~PFIZER\WYETH~4958120~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0079479	11/21/1995	MI	69.0	69		F	11/10/1995	nausea, vomiting, sweating, eyes draining;				Y					U	11/10/1995	11/10/1995	0	NONE	PVT	PVT	Premarin, Dyazide	NONE	hyperlipidermia, venous insuff., HTN, smoker	NONE~ ()~~~In patient		1						1	Conjunctivitis; Hyperhidrosis; Nausea; Vomiting	FLU3~PARKE-DAVIS~00295P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~390967~1~IM~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0079482	11/21/1995	VA	73.0	73		F	11/08/1995	nausea, no vomiting, no diarrhea, tired, legs feel weak & heavy, h/a, feel faint									U	11/07/1995	11/07/1995	0	NA	MIL	MIL	Estrogesn, Calcium Carbonate, Promethazine, ASA/Caffeine/Butalbital, Pred, Triamcinolone, Metaproterenol sulfate--INH, Ipratropium--INH, Salmeterol--INH	NA	COPD	~ ()~~~In patient		1						1	Asthenia; Headache; Myasthenic syndrome; Nausea; Syncope	FLU3~CONNAUGHT LABORATORIES~5L61010~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079483	11/21/1995	OH	32.0	31		M	11/07/1995	severe h/a x 5 days; nausea, muscle aches;				Y					Y	11/03/1995	11/03/1995	0		PUB	PUB	Relaten	NONE	NONE	NONE~ ()~~~In patient	OH95160	1						1	Headache; Myalgia; Nausea	FLU3~PFIZER\WYETH~4958137~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0079485	11/21/1995	TX	27.0	27		F		rxn began approx 2hrs p/vax;exhibited the following sxs-reddened eyes w/thick discharge; sore throat & nose w/congestion & a feeling of oppresive discomfort in the chest;diff breathing;took an allergy pill & sxs resolved w/in 24hrs;									Y	11/18/1995	11/18/1995	0	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	TX95233	1						1	Chest pain; Conjunctivitis; Dyspnoea; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61168~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079488	11/21/1995	AZ	9.0			F	11/14/1995	pt recvd vax 330PM started itching 30-min later reported to urgent care scratiching all over mild erythema, a few urticarial patches on hands;susphrine-Pred									Y				NONE	PVT	PVT	Asthmacort		hx asthma multiple allergies/mother-seizure	NONE~ ()~~~In patient		1						1	Pruritus; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~5F61119~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079490	11/21/1995	NY	53.0	53		F	11/06/1995	upper arm swelled to 2x normal size, was red & hot to touch, devel welts, could not move it w/o severe pain x 2 dyas; took 1 wk for all soreness to go away;in bed for 2 dasy w/nausea, chills, fever, h/a, aching in pelvis (felt like in bone)									Y	10/26/1995	10/26/1995	0	NONE	OTH	PVT	Provera, Premarin, Prozac	NONE	hiatal hernia-pre menopausal	NONE~ ()~~~In patient		1						1	Asthenia; Chills; Hypotonia; Nausea; Oedema peripheral; Pain; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0079493	11/21/1995	KS	32.0	32		F	11/13/1995	stinging, aching arm (even @ present 13NOV95) red bump (fifty cents piece size), when pt's hand is under cold water pain shoots up arm to shot site, fatigue									Y	11/01/1995	11/01/1995	0		PUB	PVT		NONE	NONE	NONE~ ()~~~In patient		1						1	Asthenia; Pain; Skin nodule	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078632	11/22/1995	OH	79.0	79		F	11/15/1995	pt recvd vax 15OCT95 & exp nausea, vomiting & was aspirating;adm to hosp 16OCT95 & dx'd w/pneumonia;16OCT95 pt devel swelling, redness & soreness in lt arm;dx cellulitis;					Y				U	10/15/1995	10/15/1995	0	No relevant data	OTH	PVT	Zantac, Amitriptyline		alzheimer's disease; CVA, s/p	~ ()~~~In patient	WAES95110121	1						3	Cellulitis; Infection; Myalgia; Nausea; Oedema peripheral; Respiratory disorder; Vasodilatation; Vomiting; Cellulitis; Nausea; Oedema peripheral; Pain; Pneumonia; Vasodilatation; Vomiting; Cellulitis; Nausea; Oedema peripheral; Pain; Pneumonia; Vomiting	FLU3~CONNAUGHT LABORATORIES~5F61166~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~107613~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~CONNAUGHT LABORATORIES~5F61166~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~107613~UNK~IM~LA~PNEUMO (PNEUMOVAX)~2|FLU3~CONNAUGHT LABORATORIES~5F61166~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~1076B~UNK~IM~~PNEUMO (PNEUMOVAX)~3	USA	Hospitalisation	Influenza
0079500	11/22/1995	MN	68.0	68		F	11/18/1995	inflammation involved the upper arm & down below the elbow;swollen, red, hot, itchy & painful				Y					Y	10/06/1995	10/06/1995	0	NONE	PVT	PVT	NONE	NONE	bee sting	NONE~ ()~~~In patient		1						1	Oedema peripheral; Pain; Pruritus; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1559A~2~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0079501	11/22/1995	MI	1.7	1	.7	F	11/20/1995	6cm erythema & edema no systemic rxn									Y	11/15/1995	11/15/1995	0	NONE	PVT	PUB	started amoxicillin 15NOV95	sinusitis	downs-synd, heart murmur, endocardial cushion defect	milder local rxn w/last DTP~ ()~~~In patient		1						1	Oedema peripheral; Rash	DTP~CONNAUGHT LABORATORIES~5F61071~4~IM~LL~DTP (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~5F61167~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~CONNAUGHT LABORATORIES~5F61071~4~IM~LL~HIB (ACTHIB)~1	USA		Influenza
0079502	11/22/1995	MD	60.0			M	11/20/1995	2 wks p/vax pt devel pain & numbness of rt arm, numbness & tingling in hands & feet; improving now									N		11/05/1995		nerve conduction velocity mildly abn; spinal fluid nl	PVT	PVT	Prozar, Mevacor, ASA	NONE	NONE	~ ()~~~In patient		1						1	Hypoaesthesia; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~5F61100~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079638	11/27/1995	OR				M	11/09/1995	pt recvd vax in 1990 & devel GBS which resulted in pain, fatigue, neuropathies, muscle weakness, paralyzation, numbness, tingling in the extremities, balance disturbances, SOB, sense of coldness in extremities, paresthesias;				Y				Y	N					OTH	OTH	unk	unk		~ ()~~~In patient	895317002L	1						1	Asthenia; Coordination abnormal; Dyspnoea; Guillain-Barre syndrome; Neuropathy; Pain; Paraesthesia; Paralysis	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0079649	11/27/1995	NJ	70.0	69		M	10/30/1995	pt recvd vax 19OCT95 & 24OCT95 pt exp sz;paramedics called; pt exp 2nd sz upon arrival & 3rd sz while in ER;devel dizziness & sl slurring of speech while in hosp;					Y	3			N	10/19/1995	10/24/1995	5	all lab test WNL; CT scan/EEG/EKG/lab work	PVT	OTH	Zantac		prostate surgery-has indwelling foley catheter/cystoscopy/diverticulosis		0010150950221	1						1	Convulsion; Dizziness; Speech disorder	FLU3~PARKE-DAVIS~01185P~5~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0079650	11/27/1995	WI	78.0			M	11/07/1995	pt presented to ER 22OCT w/inc weakness over the past few days, fever 101.2;problems standing-couldn't get out of sitting position;gait was unsteady, tremor present;workup for sepsis neg;had sxs of viral infect-h/a, temp spikes;poss UTI					Y					10/17/1995	10/22/1995	5	blood counts WNL; other labs (blood) insignificant	UNK	UNK	Glyburide, Zoloft, Amoxicillin		NKA; h/o diabetes, HTN, depression	~ ()~~~In patient		1						1	Asthenia; Coordination abnormal; Headache; Hypokinesia; Infection; Pyrexia; Tremor; Urinary tract infection	FLU3~PFIZER\WYETH~4958121~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0079658	11/27/1995	VA	68.0			M	10/27/1995	ventricular fibrillation;recvd vax 27OCT95 adm that day w/2 episode of V fib;had prev flu vax & pt states was sick for 6months;			Y		Y					10/27/1995	10/27/1995	0		UNK	UNK				~ ()~~~In patient		1						1	Ventricular fibrillation	FLU3~PFIZER\WYETH~4958147~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~~PNEUMO (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0079660	11/27/1995	NY	61.0	61		M	11/09/1995	pt recvd vax 26OCT95;fever 102 27OCT followed by abd pain, vomiting, sweating;28OCT hosp ER T102;adm for hydration; BX 305; progressive liver failure, SGOT 544, LDH 5099; congestive heart failure, coma;autopsy massive faulty degen of liver	Y	11/02/1995			Y				N	10/26/1995	10/27/1995	1		PVT	PVT	Insulin, Accupril, APAP	none other than hypertension & diabetes	HTN, IDDM	NONE~ ()~~~In patient		1						1	Aspartate aminotransferase increased; Blood lactate dehydrogenase increased; Coma; Hepatic failure; Hepatic steatosis; Hyperglycaemia; Laboratory test abnormal; Right ventricular failure	FLU3~CONNAUGHT LABORATORIES~~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0079664	11/27/1995	MA	68.0	68		F	11/14/1995	pt recvd vax & reported flu like sxs of fever, malaise, congestion beginning 2 days p/vax & lasting for 3 days;									Y	11/01/1995	11/12/1995	11	NONE	PUB	PUB	unk	NONE	diabetic-NKA	NONE~ ()~~~In patient		1						1	Influenza; Malaise; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61134~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079665	11/27/1995	MA	48.0	48		F	11/22/1995	inject site lt arm has remained sore since vax was received									N	10/31/1995	10/31/1995	0		PUB	PUB	Eskalith, Prozac	NONE	acute bipolar disorder	~ ()~~~In patient		1						1	Injection site pain	FLU3~CONNAUGHT LABORATORIES~5F61134~5~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079667	11/27/1995	NY	81.0	81		M	11/14/1995	chest cold, h/a, conjunctivitis, sore throat; temp not measured, pt doubts there was fever;										10/19/1995	10/24/1995	5	NONE	PUB	PUB	ASA, Niacin, Vitamins	NONE	NONE	NONE~ ()~~~In patient	NYS95067	1						1	Conjunctivitis; Headache; Lung disorder; Pharyngitis	FLU3~PARKE-DAVIS~00775P~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0079668	11/27/1995	NY	71.0	70		F	11/14/1995	chest cold, h/a, conjunctivitis, sore throat; temp not measured, doubts fever was present; 2wks later has dyspnea, tight chest										10/19/1995	10/29/1995	10		PUB	PUB				~ ()~~~In patient	NYS95066	1						1	Chest pain; Conjunctivitis; Dyspnoea; Headache; Lung disorder; Pharyngitis	FLU3~PARKE-DAVIS~00775P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0079669	11/27/1995	NY	72.0	72		F	10/27/1995	soreness when touched, when raises arm;tired feeling in arm;no discomfort when not using or touching arm;sxs improving;No MD consulted, prefers not to consult MD @ this time										10/12/1995	10/12/1995	0		PUB	PUB				~ ()~~~In patient	NYS95065	1						1	Myasthenic syndrome; Pain	FLU3~PARKE-DAVIS~00775P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0079675	11/27/1995	NY	38.0	38		F	11/20/1995	pt became sick w/flu, also bronchitis, upper resp infect, laryngiis; pt was out of work for 4 wks				Y					Y	10/24/1995	10/29/1995	5		MIL	UNK		NONE		~ ()~~~In patient		1						1	Bronchitis; Influenza; Laryngitis; Pharyngitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0079679	11/27/1995	OH	64.0	64		M	11/09/1995	the evening of flu shot had rash, unable to sleep by morning c/o rash on stomach & back;hands swelling denied diff breathing or swelling of throat;instructed to ER;9NOV95 phone call feeling better, given DPH & 2 other meds, 1 ATB				Y					Y	11/07/1995	11/07/1995	0		PUB	PUB		sinus infection dx p/shot per pt		NONE~ ()~~~In patient	OH95156	1						1	Oedema peripheral; Rash	FLU3~PFIZER\WYETH~4958150~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0079691	11/27/1995	ND	53.0	53		F	11/17/1995	c/o red eyes watering, itching burning, c/o scratchy throat & throat later on feeling full-order DPH				Y					Y	10/30/1995	10/30/1995	0	NA	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	ND95020	1						1	Conjunctivitis; Eye pain; Lacrimal disorder; Laryngospasm; Pruritus	FLU3~CONNAUGHT LABORATORIES~~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0079698	11/27/1995	TN	74.0	74		F	10/23/1995	pt had vax in lt arm on 20OCT95 upper lt arm reddened & tender to touch; pt has not been able to lie on arm since vax;				Y					Y	10/20/1995	10/20/1995	0	NA	PUB	PUB	Capoten, Hytrin, Premarin, Pepcid, Vitamins, Calcium	NONE	NONE	NA~ ()~~~In patient	TN95119	1						1	Injection site hypersensitivity; Injection site pain; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61126~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~428501~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0079700	11/27/1995	GA	26.0	26		F	11/03/1995	fever over 102, swelling, aching soreness p/2 days; entire upper 1/2 arm & shoulder having joint pain, localized area-bright red report from client;				Y					U	10/25/1995	10/27/1995	2	NONE	PUB	PUB	verapamil; Paxil; Pepcid	NONE		~ ()~~~In patient	GA95191	1						1	Arthralgia; Injection site hypersensitivity; Injection site reaction; Myalgia; Oedema; Pain; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4958133~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~390968~1~IM~RL~PNEUMO (PNU-IMUNE)~1|TD~LEDERLE LABORATORIES~429310~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0079702	11/27/1995	GA	66.0	66		F	10/26/1995	lt arm sore, swollen red area approx 100mm x 110mm area feel warm to touch;c/o pain under lt rib cage, was seen by PMD 25OCT95;				Y					Y	10/25/1995	10/26/1995	1	NONE	PUB	PUB	NONE	NONE	demerol, Codeine, ASA, EES	~ ()~~~In patient	GA95189	1						1	Oedema peripheral; Pain; Vasodilatation	FLU3~PARKE-DAVIS~02065P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~390935~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0079703	11/27/1995	GA	4.0	4		M	10/25/1995	red-raised rash on face, neck & chest as reported by mom; DPH given;MD recommends no flu shot d/t allerg rxn (rash)				Y						10/20/1995	10/20/1995	0		PUB	PUB	Albuterol, Vanceril, Zantac	asthma	asthma	~ ()~~~In patient	GA95188	1						1	Hypersensitivity; Rash maculo-papular	FLU3~PARKE-DAVIS~01285P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0079704	11/27/1995	GA	34.0	34		F	10/24/1995	chills in AM; fever about 530PM 102 x 2 days then 99.8 x 2 days then 102 x 2 days;12OCT95 saw MD;13OCT95 temp 104;14OCT95 & cont 100;APAP decreases fever some nausea;				Y					Y	10/04/1995	10/12/1995	8	urinalysis-poss UTI	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	GA95187	1						1	Chills; Pyrexia; Urinary tract infection	FLU3~PARKE-DAVIS~00985P~4~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0079706	11/27/1995	KY	29.0	29		F	11/17/1995	edema in lt arm, dec perfusion in hand, pain in lat arm from neck to fingers				Y						11/12/1995	11/13/1995	1		PUB	UNK				~ ()~~~In patient		1						1	Oedema peripheral; Pain; Peripheral vascular disorder	FLU3~PFIZER\WYETH~4958232~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0079707	11/27/1995	MA	65.0			M	11/07/1995	pt recvd vax @ flu clinic & sat for 10mins & began to exp profuse diaphoreitc, BP dec 80/40 (nl 150/90 per pt)-called 911 given Adrenalin, to hosp				Y					Y	10/26/1995	10/26/1995	0		OTH	UNK	NONE	NONE	NONE	~ ()~~~In patient	MA9527	1						1	Hyperhidrosis; Hypotension	FLU3~CONNAUGHT LABORATORIES~5F61134~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0079708	11/27/1995	MA	58.0	58		M	11/07/1995	pt had flu vax 530PM 19OCT95 for the first time; @11PM had shaking chills, sclera very bloodshot, temp elevation (102);transported to hosp ER by amb;MD in ER treated BP elevation but other test neg;tx APAP				Y					Y	10/19/1995	10/19/1995	0	Urinalysis, CXR all neg, BP elevated; cardiac monitor, bloodwork;	PUB	PUB	NONE	NONE	No allergies or known med conditions	~ ()~~~In patient	MA9526	1						1	Chills; Conjunctivitis; Hypertension; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61134~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0079711	11/27/1995	KS	68.0	68		F	10/24/1995	pt stated it hit lungs & felt like was going to explode from the inside;				Y					Y	10/23/1995	10/23/1995	0		PUB	PUB		NONE	NONE	~ ()~~~In patient	KS95051	1						1	Lung disorder; Pain	FLU3~CONNAUGHT LABORATORIES~5F61021~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0079712	11/27/1995	WA	57.0	57		F	11/22/1995	reports local rxn @ inj site-raised hard red area 6.5cm, painful resolved w/warm packs;no systemic effects									Y	11/16/1995	11/17/1995	1	NA	OTH	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~PFIZER\WYETH~49158112~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079714	11/27/1995	WI	40.0			F		aching joints, large reddened rxn @ inj site;person felt awful for 2 days;states eat eggs occassionally but suspects that has been sick from eating eggs in the past;suspicion that maybe allerg to eggs									U	10/23/1995	10/24/1995	1		UNK	UNK			person verbalized problems w/eggs in the past;did not state had problems w/eggs when recvd vax, though info was provided to her			1						1	Arthralgia; Injection site hypersensitivity; Malaise	FLU3~PFIZER\WYETH~4958081~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079722	11/27/1995	CT	55.0	55		M	11/18/1995	quarter size lump noted rt axilla approx 24hrs p/vax-mild tenderness;no fever;warm soaks each noc;resolved p/approx 2wks;									Y	10/30/1995	11/01/1995	2	NONE	PVT	OTH		NONE	NONE	~ ()~~~In patient		1						1	Myalgia; Skin nodule	FLU3~PFIZER\WYETH~4958113~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079723	11/27/1995	VT	63.0	63		F	11/18/1995	feel very tired on 29OCT-30OCT fever, chills, h/a, diarrhea had it 10-12 days; fever 100-101;flu shot given 25OCT95 still feel tired;nurse told pt that she had 'start of virus' when vaxed, made it 'twice as diff'									Y	10/25/1995	10/29/1995	4	NONE	PUB	UNK		start of virus	low immunity	~ ()~~~In patient		1						1	Asthenia; Chills; Diarrhoea; Headache; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079724	11/27/1995	UT	90.0	90		F	11/10/1995	'entire body adversely affected,'pain arm/hand w/protruding veins/swelling elbow to fingers,stiff/sore neck glands/ha;flashing colors lights in eyes;stomach cramps, n&d,burning condition in kidneys;inability to walk; 'nervous system chaos'				Y					N	10/17/1995	10/17/1995	0	eye exam-eye phys	PUB	PUB	Lanoxin, Metoprolol	NONE	pacemaker implant-15yrs ago	NONE~ ()~~~In patient	UT950321	1						1	Angiopathy; Asthenia; Diarrhoea; Hallucination; Hypokinesia; Lymphadenopathy; Nausea; Neuropathy	FLU3~PFIZER\WYETH~4958120~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0079726	11/27/1995	VA	18.0	18		M	11/17/1995	unable to open mouth more than 1/2;(had soreness in arm w/in 15min, which lasted 1wk)saw MD on 14NOV95 & was treated w/Ibuprofen;had 2-3 blinding h/a's since recvd vax									Y	11/01/1995	11/11/1995	10	NONE	OTH	PUB	Seldane, Allergy inj twice/wk	NONE	exercise induced asthma, allergies-PCN, Emycin, codiene, ampicillin, molds, trees, grasses	~ ()~~~In patient		1						1	Headache; Movement disorder; Pain	FLUX~UNKNOWN MANUFACTURER~~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079729	11/27/1995	AR	42.0	42		F	10/27/1995	red raised area approx 5cm diam around inj site, warm to touch;pt's temp 98.6 orally;states pain @ inj site radiating into lt shoulder & neck, deniesnuchal stiffness;states had severe h/a this AM rellieved w/APAP									Y	10/26/1995	10/26/1995	0	NONE	PUB	PUB	NONE	NONE	allergies: Mycin, -cillin drugs, & codiene	~ ()~~~In patient	AR9576	1						1	Headache; Injection site hypersensitivity; Injection site pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~5F61119~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079730	11/27/1995	MI	67.0	67		F	11/06/1995	pain in lt arm around inj site so painful could not sleep on lt side;reported to clinic 30OCT95;scheduled for carpal-tunnel procedure in lt hand 31OCT95;advised to call orthopedic surgeon a/31OCT;lump is still palpable in lt arm;									Y	10/24/1995	10/25/1995	1	NONE	PUB	PUB	Mcironase, Advil & Roboxin	NONE	diabetes;lumpectomy in rt brease 10yrs ago	NONE~ ()~~~In patient	MI95135	1						1	Injection site pain; Skin nodule	FLUX~UNKNOWN MANUFACTURER~4958114~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079735	11/27/1995	AZ	70.0	70		F	11/20/1995	2wks p/vax pt devel hives (torso, arms, & shoulders) when this subsided had small chicken pox-like break out in same area these have left litlle scars									Y	10/20/1995	11/03/1995	14	NONE	PUB	OTH	NONE	NONE	allerg to almonds & iodine	~ ()~~~In patient		1						1	Dermatitis bullous; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079736	11/27/1995	ND	60.0	60		F	11/13/1995	sniffles on Saturday, next day, w/sl boyd aches;next day Sunday afternoon broke out w/react flushed skin on face, arms, lower extremities, esp groin area w/sl rasied feeling & some hive like skin elevations;also itching									Y	11/10/1995	11/12/1995	2	NA	OTH	PUB	NONE	NONE	NONE	NA~ ()~~~In patient	ND95019	1						1	Myalgia; Pruritus; Rash maculo-papular; Rhinitis; Urticaria; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~4958228~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079739	11/27/1995	MO	70.0	69		F	11/13/1995	pt states shot gave her the flu;had scratchy throat 9OCT95 & on 10OCT95 devel aching, h/a & cough;states it lasted a wk & then got a bad cold w/ sl yellow productive cough;									Y	10/05/1995	10/09/1995	4	NONE	PUB	PUB	Premarin	NONE		NONE~ ()~~~In patient	MO95090	1						1	Cough; Headache; Influenza; Myalgia; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~5F61099~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079741	11/27/1995	WA	24.0	24		F	11/20/1995	tender lt axilla 12hrs p/vax T98.7, flu shot 15NOV95 prescribed 17NOV9 w/soft tissue, swelling & 1.5cm tender node anterior axilla									Y	11/15/1995	11/16/1995	1	NONE	OTH	PVT	Orthnovum 777	NONE	NONE	~ ()~~~In patient		1						1	Lymphadenopathy; Oedema; Pain	FLUX~UNKNOWN MANUFACTURER~5F61100~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079742	11/27/1995	TN	58.0	58		F	10/30/1995	devel knot size of palm of hand w/2 red hand below it-talked w/MD who advised heat & DPH cleared p/2days									Y	10/18/1995	10/19/1995	1	NONE	PUB	PUB	Premarin & hi BP rx	NONE	NONE	~ ()~~~In patient	TN95117	1						1	Skin nodule; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~5F61126~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079743	11/27/1995	VA	28.0	28		F	11/03/1995	devel reddened area 1 1/2cm in diameter @ the inj site following flu vax;also devel generalized itching approx 18hrs p/vax									Y	11/01/1995	11/01/1995	0		OTH	PUB	NA	NA	NA	~ ()~~~In patient	VA95081	1						1	Injection site hypersensitivity; Pruritus	FLUX~UNKNOWN MANUFACTURER~4958115~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079744	11/27/1995	MA	42.0	42		F	11/14/1995	pt recvd vax & exp soreness @ the site of inj (lt deltoid area) which progressed to shoulder & neck area & acorss to rt shoulder 2 dasy p/vax; h/a across nasal sinuses also reported during this time;sxs lasted 1 1/2wk									Y	10/31/1995	11/03/1995	3	NONE	OTH	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Headache; Injection site pain; Neck pain; Pain	FLUX~UNKNOWN MANUFACTURER~5F61134~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079747	11/27/1995	MA	72.0			F	11/20/1995	17NOV95 pt felt ill was in bed sick w/a temp, nausea, & chills;started to feel better on 20NOV95;no treatment did not call A MD & took nothing;									Y	11/16/1995	11/17/1995	1		PUB	UNK		NA		~ ()~~~In patient	MA9522	1						1	Chills; Malaise; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~5F61134~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079600	11/28/1995	CA	4.0	4		M	11/20/1995	about 10 days p/vax pt devel vomiting & intermittent dec mental status;@ less than 2 wks post vax pt dx w/grade II-III Reye synd;no other contributing factors were identified;					Y	4			Y	10/13/1995	10/19/1995	6	LFT's were very elevated;amonia >100;viral hepatitis screens neg	PVT	PVT	NONE	NONE	intermittant asthma	~ ()~~~In patient		1						1	Blood urea increased; Delirium; Hepatic function abnormal; Thinking abnormal; Vomiting	FLU3~CONNAUGHT LABORATORIES~5F61168~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0079605	11/28/1995	MA	42.0	42		M	11/20/1995	pt recvd vax 17OCT95 & exp rash near the site of inj to rt armpit manifested 18OCT, lympahtic swelling & tenderness in the rt armpit & radiating pain to the rt elbow manifested 19OCT;overnoc muscular aches & tiredness on 19OCT;face numb				Y					Y	10/17/1995	10/19/1995	2	NONE	PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Asthenia; Injection site reaction; Lymphoedema; Myalgia; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~5J61007~6~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0079607	11/28/1995	OH	73.0	73		M	10/18/1995	pt has recvd vax for past 10 yrs w/o incident;pt recvd flu vax 12OCT  12NM & 14OCT 4-5PM began experiencing lt arm discomfort, lt hip discomfort like bone was breaking, nausea, h/a lt temple, eyes sore, no appetite				Y					N	10/12/1995	10/14/1995	2		OTH	PVT	Insulin; Lasix, Lescol	NONE	diabetes, HTN	~ ()~~~In patient		1						1	Anorexia; Arthralgia; Eye pain; Headache; Nausea; Pain	FLU3~CONNAUGHT LABORATORIES~5F61112~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0079609	11/28/1995	VA	6.0	6		M	11/21/1995	14NOV95 began w/redness & swelling;15NOV redness & swelling inc;16NOV hot w/blisters, painful swelling 5-6 of upper arm w/bruising put on Pred				Y					Y	11/13/1995	11/14/1995	1	NA	PVT	PVT	Ventolin/Intal via nubulizer	has RAD	Ceftin;has unidentified genetic disorder, sz disorder, pulmonary dysfunction	pt's sibling exp rxn NOV94 @ 9yrs w/MMR/flu #2 dose~ ()~~~In Sibling		1						1	Ecchymosis; Oedema peripheral; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61024~3~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0079611	11/28/1995	CO	72.0	72		F	11/14/1995	pt recvd vax; devel large hematoma and compartment syndrome in rt arm; pt was hospitalized; pt was later found to have idosynocrati factor VIII dec.					Y				U	11/07/1995	11/09/1995	2		PVT	PVT	THYROID,ATROPAT,MAXAIN,TRANEXNE,KCI,LASIX,ZANTAC,TERBUTALINE;	copd	none known	~ ()~~~In patient		1						1	Blood disorder; Haemorrhage; Tenosynovitis	FLU3~PFIZER\WYETH~4958116~2~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0079612	11/28/1995	OH	71.0	71		F	10/18/1995	immed following flu vax pt reports feeling weak; also c/o sore knees, lt arm sore, just pushing to get everything done;no appetite				Y					N	10/12/1995	10/12/1995	0		OTH	PVT	ASA; Lescol, Premarin	NONE	HTN	~ ()~~~In patient		1						1	Anorexia; Arthralgia; Asthenia; Pain	FLU3~CONNAUGHT LABORATORIES~5F61112~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0079615	11/28/1995	NC	34.0	34		F	11/03/1995	w/in 10mins of vax pt returned to vax area c/o rash of lt arm;observed hives on lt arm distal from administration site;pt also c/o feeling flushed;given DPh & Epi				Y					Y	10/30/1995	10/30/1995	0	NONE	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient	NC95123	1						1	Rash; Urticaria; Vasodilatation	FLU3~PARKE-DAVIS~01159D~3~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0079616	11/28/1995	MA	75.0	75		F	11/20/1995	extreme dizziness, nausea & vomiting until about 6PM;									Y	11/02/1995	11/12/1995	10		PUB	UNK		NONE	NONE	~ ()~~~In patient		1						1	Dizziness; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079620	11/28/1995	WA	33.0	33		M	11/16/1995	exp violent shaking, chills, feels feverish & achy, 8hrs p/vax 15NOV95;										11/15/1995	11/15/1995	0		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Chills; Myalgia; Pyrexia; Tremor	FLU3~PARKE-DAVIS~01595P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0079621	11/28/1995	CO	33.0	33		M	11/20/1995	pt recvd vax on 10NOV95;1-3 hrs later devel sxs of h/a, muscle aches which lasted approx 30hrs;									Y	11/10/1995	11/10/1995	0	NONE	OTH	PVT	NONE	NONE	NONE	NONE known~ ()~~~In patient		1						1	Headache; Myalgia	FLU3~CONNAUGHT LABORATORIES~5F61014~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079629	11/28/1995	NY	66.0	66		F	11/20/1995	six large red spots size, one w/pus;red marks are still visible on 20NOV									Y	10/20/1995			NONE	PUB	PUB	cortizone	NNE	allergic to animal fur	NONE~ ()~~~In patient	NYS95072	1						1	Dermatitis bullous	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079630	11/28/1995	NJ	68.0	68		F		severe chills 7hrs p/vax & chills lasted about 2hrs followed by fever up to 103 which subsided during the noc; rxn lasted about 24hrs;									Y	11/08/1995	11/08/1995	0	NONE	PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	NJ9552	1						1	Chills; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0079631	11/28/1995	NM	63.0	63		F	11/16/1995	pt recvd vax 2NOV95 & 4NOV95 woke w/earache, & sore throat;evening of 4NOV95 throat very imflammed, cough, loss of voice which lasted 2 days; 14NOV95 persistant evening cough									Y	11/02/1995	11/04/1995	2		PUB	OTH	OTC for cough	NONE	NONE	~ ()~~~In patient	NM95023	1						1	Cough; Ear pain; Laryngitis; Pharyngitis	FLU3~PFIZER\WYETH~4958128~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079632	11/28/1995	OH	41.0	40		F	11/20/1995	pt recvd vax 6NOV95 815AM;hives appeared 7NOV95 own MD contacted 7NOV95 MD instructed pt to take DPH;9NOV95 pt contacted stating hives were not any better & DPH inc; see MD									Y	11/06/1995	11/07/1995	1	NA	PUB	PUB	NONE	NA	NONE	NA~ ()~~~In patient	OH95162	1						1	Urticaria	FLU3~PARKE-DAVIS~01285P~2~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0079636	11/28/1995	ID	26.0	26		F	11/21/1995	c/o numbness in lt arm & hand, exp w/activity (i.e. driving, breastfeeding) since time of flu vax; denies swelling, redness, or inc temp @ site;recommended to see PMD				Y					N	11/09/1995	11/09/1995	0	NA	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	ID95066	1						1	Paraesthesia	FLU3~CONNAUGHT LABORATORIES~5F61012~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0067667	11/29/1995	MI				F	09/20/1995	dizzy,nauseated,SOB approx 5-10mins p/inj;pt is asthmatic so used 2 puffs from Proventil & 3 tbsp of DPH;felt like tongue was swollen & had tightness of chest;went to ER & given epi,steroids & tagamet				Y					Y	10/18/1994	10/18/1994	0		PUB	OTH		NONE	poss sulfa allergy as a child, allergy to iodine, vomits w/milk	~ ()~~~In patient	CO5629	1						3	Asthma; Chest pain; Condition aggravated; Dizziness; Dyspnoea; Nausea; Tongue oedema	FLU3~CONNAUGHT LABORATORIES~4F51024~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Emergency room visit	Influenza
0067849	11/29/1995	KY	21.0	21		M	09/20/1995	itchiness,then redness @ site,then broke out in hives all over w/some sl tightness in chest;had wheal in axilla & pubic area;went to employee hlth & was given 2 doses of epi;hives resolved;				Y					Y	10/19/1994	10/19/1994	0		OTH	OTH	NONE	NONE	environmental allergies	NONE~ ()~~~In patient	CO5624	1						2	Chest pain; Injection site hypersensitivity; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51146~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0067862	11/29/1995	NJ	54.0	53		F	09/20/1995	pt recvd vax; itchy, hives & swelling of lips; 14dec94 f/u: tx w/ dph & steroids;				Y					Y	10/24/1994	10/25/1994	1		OTH	OTH	none	none	none	none~ ()~~~In patient	CO5641	1						2	Face oedema; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51113~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0068055	11/29/1995	OR	57.0	57		F	09/20/1995	started w/little soreness on tuesday,on Wed could not move arm;called clinic to report on Thursday & was seen c/o serious pain in shoulder area;given by jet injector;took some advil & will be seeing own MD for f/u;				Y					U	10/24/1994	10/25/1994	1		PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	CO5657	1						2	Hypokinesia; Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~4F51152~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0068083	11/29/1995	IN	39.0			F	09/20/1995	pt recvd vax; welt like rash that flare up on & off on cheeks, face & 1 side of neck; no change in habits; no tx required;									Y	10/20/1994	10/21/1994	1		PUB	UNK		none	none	none~ ()~~~In patient	CO5640	1						2	Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51165~2~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0068159	11/29/1995	NH	47.0	47		F	09/20/1995	pt recvd vax;joint swelling,pain;to md;tx w/ naprosyn;progressive swelling,tenderness,immobility w/ swelling in wrists & hands;to rheumatologist;dx as serum arthritis not necessarily assoc w/ vax;tx pred & sx resolved;				Y					N	10/25/1994	10/26/1994	1	sed rate showed inflammation r/o lupus, RA, lyme;joint fluid shows inflammation	PUB	OTH	zestril	none	hypertension	none~ ()~~~In patient	CO5725	1						2	Arthralgia; Arthritis; Hypokinesia; Laboratory test abnormal; Osteoarthritis	FLU3~CONNAUGHT LABORATORIES~4F51016~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0068393	11/29/1995	MA	51.0	51		F	09/20/1995	pt recvd vax; fever of 101 day later w/ swollen, crusty eyes, red puffy face;unable to sleep; severe HA;									Y	11/01/1994	11/01/1994	0		PUB	PUB	none	none	none	none~ ()~~~In patient	CO5708	1						2	Conjunctivitis; Face oedema; Headache; Insomnia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51025~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0068394	11/29/1995	MA	54.0	54		M	09/20/1995	pt recvd vax; congestion, blurred vision, HA, chills & n;									Y	10/28/1994	10/28/1994	0		OTH	OTH	none	none	none	none~ ()~~~In patient	CO5709	1						2	Amblyopia; Chills; Headache; Nausea; Rhinitis	FLU3~CONNAUGHT LABORATORIES~4F51025~2~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0068501	11/29/1995	WA	38.0			F	09/20/1995	shaking chills, violent retching, fever 105;sudden onset 2hrs p/vax;no other evidence of illness;hospitalized;blood cultures neg;					Y				Y	10/21/1994	10/21/1994	0		PVT	UNK	Premarin	NONE	allergy to sulfa	~ ()~~~In patient	CO5666	1						2	Chills; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51158~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0068521	11/29/1995	DC	19.0	19		F	09/20/1995	itchy, round elevated, red irregular rash on arm & lt deltoid;approx 12 lesions, no vesicles;treated w/DPH;				Y					U	11/07/1994	11/07/1994	0		OTH	OTH	NONE	NONE	no allergies	NONE~ ()~~~In patient	CO5683	1						2	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~4F51071~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0068580	11/29/1995	IL	61.0	61		F	09/20/1995	bumps on feet,hands,& face;gums became sore;Saturday ,top part of body began hurting-sensitive to touch or clothing;some itching all over on Friday;bumps gone on Monday;gums better;no complaint of tiredness;poss temp on sunday;no tx									Y	10/25/1994	10/26/1994	1		PUB	PUB	NONE	NONE	allergy to sulfa, CA of uterus in 1980	pt exp flu-like sxs p/influenza vaccine @ age 58~ ()~~~In patient	CO5690	1						2	Pain; Pruritus; Pyrexia; Rash; Stomatitis	FLU3~CONNAUGHT LABORATORIES~4F51060~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0068900	11/29/1995	NY	27.0			F	09/20/1995	swelling of lt side of face,tight chest,palpitations (100 pulse rate),BP = 90/56,resp=24;sent to ER;on exam,lung clear,no stridor,no laryngospasm;given Epi;d/c 4PM;				Y					Y	11/01/1994	11/01/1994	0		OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	CO5687	1						2	Chest pain; Face oedema; Hypotension; Palpitations	FLU3~CONNAUGHT LABORATORIES~4F51025~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0068965	11/29/1995	ME	17.0	17		M	09/20/1995	pt recvd vax; localized redness & hives all over; tx w/ dph & atarax;									Y	10/21/1994	10/21/1994	0		PVT	OTH	proventil, intal, tylaid, asthmacort	none	long time hx of asthma & oth allergies;	~ ()~~~In patient	CO5637	1						2	Injection site hypersensitivity; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51145~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0069017	11/29/1995	UT	49.0	49		F	09/20/1995	pt recvd vax; puffy & mattered eyes; chest tightness & dyspnea, hives, gen malaise, cough; started w/in 3 hrs & lasted about 36 hrs									Y	11/07/1994	11/07/1994	0		PUB	PUB	none	none	none	none~ ()~~~In patient	CO5730	1						2	Chest pain; Conjunctivitis; Cough; Dyspnoea; Face oedema; Malaise; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51071~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0069018	11/29/1995	WY	57.0	57		M	09/20/1995	pt recvd vax; stiff neck 48 hrs p/ vax; still c/o stiff neck 21nov94,nausea & general malaise;									U	11/15/1994	11/17/1994	2		PUB	PUB		none	none	none~ ()~~~In patient	CO5731	1						2	Malaise; Nausea; Nuchal rigidity	FLU3~CONNAUGHT LABORATORIES~4F51071~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0069188	11/29/1995	WY	26.0	25		F	09/20/1995	pt recvd vax;swollen,red & mattered eyes 4 hrs p/ inject;chest congestion,cough,swollen glands & ear ache 24 hrs later & then d;									Y	11/21/1994	11/21/1994	0		PUB	PUB	none	none	none	none~ ()~~~In patient	CO5738	1						2	Conjunctivitis; Cough; Diarrhoea; Ear pain; Face oedema; Lung disorder; Lymphadenopathy	FLU3~CONNAUGHT LABORATORIES~4F51071~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0069231	11/29/1995	ID	64.0	64		F	09/20/1995	pt recvd vax; started to itch all over body;slightly raised erythematous rash;to dermatologist,prescribed atarax & cortisone cream;hive like appearance rash;3dec94 f/u: itching began 3 hrs p/ inject;cont to inc w/ red, slightly raised;pred				Y					Y	10/13/1994	10/14/1994	1		PUB	PUB	toperol xl, procardia;	none	heart condition	none~ ()~~~In patient	CO5638	1						2	Pruritus; Rash maculo-papular; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51055~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0069304	11/29/1995	PA				F	09/20/1995	pt recvd vax & devel cellulitis;devel erythema,edema & temp w/in 2-3 days;seen in ER 7NOV94 & dx w/cellulitis & treated w/keflex				Y					Y	11/04/1994	11/06/1994	2		PVT	PVT				~ ()~~~In patient	CO5775	1						2	Cellulitis; Oedema; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~4F51012~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0069305	11/29/1995	PA				F	09/20/1995	reddened, inflamed & tender inj site x 2 days p/receipt									Y	11/08/1994	11/10/1994	2		PVT	PVT				~ ()~~~In patient	CO5774	1						2	Injection site hypersensitivity; Injection site inflammation; Injection site pain	FLU3~CONNAUGHT LABORATORIES~4F51155~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0069356	11/29/1995	IN	61.0	61		F	09/20/1995	severe h/a followed by sore arm p/15-20mins;went home & slept for 2hrs & sx resolved;									Y	11/09/1994	11/09/1994	0		PUB	OTH	slo bid, capotin, procardia	NONE	HTN & cardiac problem	NONE~ ()~~~In patient	CO5688	1						2	Headache; Myalgia	FLU3~CONNAUGHT LABORATORIES~4F51165~2~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0069456	11/29/1995	IL	63.0	63		F	09/20/1995	pt recvd vax;w/in 15 mins felt throat tightening & tingling sensation;some swelling 2-3 deep purple area below articulation point of joint;dph given;next am ,arm felt very bad;to md;arm soreness;				Y					Y	11/09/1994	11/09/1994	0		PUB	OTH	thyroid med, provera, premarin	very good hlth	thyroid problem	in pt, allergic type rxn p/ swine flu;~ ()~~~In patient	CO5743	1						3	Ecchymosis; Laryngospasm; Myalgia; Oedema; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51016~3~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Emergency room visit	Influenza
0069676	11/29/1995	VA	69.0	69		F	09/20/1995	pt recvd vax; burning in throat, tongue, lips swollen w/ shortness of breath; to er w/ dph then pred & resolved;				Y					Y	11/28/1994	11/28/1994	0		PUB	PUB		none	allergy to sea foods	none~ ()~~~In patient	CO5735	1						2	Dyspnoea; Face oedema; Pharyngitis; Tongue oedema	FLU3~CONNAUGHT LABORATORIES~4F51158~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0069850	11/29/1995	NJ				F	09/20/1995	pt recvd vax;cold virus,cough,nasal congestion,ear pain since vax;tx w/ zefrex & biaxan for ruptured ear drum;				Y					N	11/10/1994	11/11/1994	1		OTH	PVT		none		~ ()~~~In patient	CO5749	1						2	Cough; Ear disorder; Ear pain; Infection; Rhinitis	FLU3~CONNAUGHT LABORATORIES~4F51145~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0069855	11/29/1995	ME	47.0	47		F	09/20/1995	pt recvd vax & exp itching & swelling @ inj site;ice packs applied & DPH given;2PM pt transported to hosp ER because SOB; given epi;monitored then released;				Y					Y	10/20/1994	10/20/1994	0		PUB	PVT	Premarin	NONE	NONE	NONE~ ()~~~In patient	CO5762	1						2	Dyspnoea; Injection site oedema; Pruritus	FLU3~CONNAUGHT LABORATORIES~4F51016~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0069879	11/29/1995	ME	57.0	57		F	09/20/1995	itching & swelling @ inj site;ice applied & DPH given;monitored until 1030AM w/o addl problems;									Y	10/20/1994	10/20/1994	0		PUB	PVT	Premarin	NONE	NONE	NONE~ ()~~~In patient	CO5761	1						2	Injection site oedema; Pruritus	FLU3~CONNAUGHT LABORATORIES~4F51016~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0070310	11/29/1995	AR	37.0	37		F	09/20/1995	immed pain upon inj of vax;shot was given on Friday afternoon & arm was so sore throughout the weekend that could not use it;pain cont x 2 wks;									Y	10/28/1994	10/28/1994	0		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	CO5785	1						2	Myalgia; Pain; Hypokinesia; Injection site pain; Myalgia	FLU3~CONNAUGHT LABORATORIES~4F51113~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~4F51113~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0070311	11/29/1995	AR	34.0	34		F	09/20/1995	could feel medication in arm; arm began to hurt immed;could not move arm that weekend although the pain was not so severe;pain cont to hurt for wks;									Y	10/28/1994	10/28/1994	0		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	CO5786	1						2	Hypokinesia; Pain; Hypokinesia; Pain	FLU3~CONNAUGHT LABORATORIES~4F51113~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~4F51113~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0079758	11/29/1995	PA	71.0	70		M	11/22/1995	flu like synd w/gen myalgias, arthralgias sinus congestion fever, chills, & yellow/white phlegm									N	09/15/1995	09/16/1995	1	NONE	PVT	PVT	Diabinese;Claritin D	DM, HTN, ASVD, PVD, rtBBB, chr sinusitis	DM, HTN, ASVD, PVD, rt BBB, chr sinusitis	~ ()~~~In patient		1						1	Arthralgia; Chills; Influenza; Myalgia; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61100~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079759	11/29/1995	MO	78.0	78		M	11/20/1995	5OCT95 pt exp chills described by pt as shaking & didn't feel good; pt did not take temp & did not take APAP or ASA;went to be 830PM; slept well & recovered by morning 6OCT95;									Y	10/05/1995	10/05/1995	0	NONE	PUB	PUB	Ventolin	NONE		NONE~ ()~~~In patient	MO95091	1						1	Chills; Malaise; Tremor	FLU3~CONNAUGHT LABORATORIES~5F61099~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079761	11/29/1995	CA	66.0	66		F	11/21/1995	severe muscle wasting in upper arms & all the way down to hands w/very deep, pain in upper arm especially;arthritis was very mild a/shot;activated p/shot;BP 200/109;pain in upper arms;pain & msucle wasting was severe next day;				Y					N	10/20/1995	10/20/1995	0		PUB	PVT	Ibuprofen, Vasotec	rheumatoid arthritis, High BP	NONE	NONE~ ()~~~In patient		1						1	Arthritis; Condition aggravated; Hypertension; Hypokinesia; Muscle atrophy; Myasthenic syndrome; Pain	DT~CONNAUGHT LABORATORIES~4G61080~UNK~IM~RA~DT ADSORBED (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4958151~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0081336	11/29/1995	WA	47.0	47		F	09/20/1995	large local rxn w/erythema & induration causing a 2 inc in diameter of arm from elbow to shoulder;occurred 30hrs p/inj;treated w/DPH;dx cellulitis-adm to hosp 3 days for tx w/IV ATB;				Y	Y	3			Y	11/16/1994	11/16/1994	0		PVT	PVT	Catapress, dyaesic	48hrs a/vax,suprapubic infect w/erythema	HTN	NONE~ ()~~~In patient	CO5711	1						1	Cellulitis; Injection site hypersensitivity; Injection site mass; Injection site reaction	FLU3~CONNAUGHT LABORATORIES~4F51072~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0082145	11/29/1995	MI	41.0	40		M	09/20/1995	pt recvd vax;fever,chills,HA,n,stomach cramps & d;				Y					Y	11/18/1994	11/18/1994	0		UNK	UNK	none	none	none	in pt, soreness or feverish feeling w/ flu vax in the past~ ()~~~In patient	CO5714	1						1	Abdominal pain; Chills; Diarrhoea; Headache; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51089~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082146	11/29/1995	OH	36.0			F	09/20/1995	pt recvd vax; itchy, prickly sensation in legs around ankles & calves; tried dph & topical cream w/out relief; to see md;				Y					N	11/16/1994	11/16/1994	0		PUB	UNK	none	none	allergy to eggs as a child, but now can eat w/out problems	none~ ()~~~In patient	CO5715	1						1	Paraesthesia; Pruritus	FLU3~CONNAUGHT LABORATORIES~4F51072~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082147	11/29/1995	MD	63.0	63		F	09/20/1995	pt recvd vax;axillary adenopathy tx w/ moist heat compress;13jan95 f/u: complete recovery				Y					Y	11/10/1994	11/11/1994	1		PVT	OTH	pred, inhalers	none	COPD, asthma, exersional dyspnea & acute bronchospasm	none~ ()~~~In patient	CO5716	1						1	Lymphadenopathy	FLU3~CONNAUGHT LABORATORIES~4F51022~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082149	11/29/1995	NJ	43.0	43		F	09/20/1995	pt recvd vax; cellulitis size of 50 cent piece									Y	11/28/1994	11/29/1994	1		PVT	PVT	zoloft, ventolin, atrovent, vanceril	none		~ ()~~~In patient	CO5729	1						1	Cellulitis	FLU3~CONNAUGHT LABORATORIES~4F51012~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082154	11/29/1995	IL	3.0			F	09/20/1995	pt recvd vax; eczema type raised rash the size of quarter at inject site;				Y					U	11/17/1994	11/24/1994	7		PVT	UNK				~ ()~~~In patient	CO5736	1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082155	11/29/1995	IN	70.0	69		F	09/20/1995	pt recvd vax;got SOB,felt like could not move,throat closing up;took vaporizer & inhaler;proventil;									Y	11/08/1994	11/08/1994	0		PUB	OTH	thodura, hisminol, provental;		asthma for the last 8-10 yrs;	flu shot last year w/ no problems;~ ()~~~In patient	CO5737	1						1	Dyspnoea; Hypokinesia; Laryngospasm	FLU3~CONNAUGHT LABORATORIES~~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082157	11/29/1995	MO	38.0	38		F	09/20/1995	pt recvd vax;urticarial hives not resolved as of 5dec94;nl SED rate & chemistry panel;tx w/ pred;13fe95: cont on antihistamines;				Y					U	10/05/1994	10/08/1994	3	sed rate-nl;chemistry panel nl;	OTH	OTH	none	none	none	none~ ()~~~In patient	CO5739	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51164~1~SC A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082158	11/29/1995	CA	54.0	54		F	09/20/1995	pt recvd vax; severe HA, sore throat, productive cough & diff breathing (due to swollen throat); T 100; to er & tx w/ inject of rocephin; as of 16nov94 HA & sore throat persist;				Y					N	11/04/1994	11/05/1994	1		PVT	OTH	mevaco, hydrodiuril, lopressor, provera, premaring, kcl, liournal;			~ ()~~~In patient	CO5741	1						1	Cough; Dyspnoea; Headache; Laryngospasm; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51025~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082159	11/29/1995	NH	37.0	37		M	09/20/1995	pt recvd vax;red eyes,retrobulbar pressure in face & teeth,sore throat,HA & chills w/in 2hrs of inject;given epi & dph;watched for 2 hrs;was shaky w/ red sclera;took apap & covered w/ blanket which helped HA & fever;				Y					Y	10/21/1994	10/21/1994	0		OTH	OTH	none	none	none	none~ ()~~~In patient	CO5742	1						1	Chills; Conjunctivitis; Headache; Pain; Pharyngitis; Pyrexia; Tremor	FLU3~CONNAUGHT LABORATORIES~4F51025~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082161	11/29/1995	TX	45.0	45		F	09/20/1995	pt recvd vax; chest tightness, chills & fever lasted 24 hrs; very sore arm for 203 days;									Y	11/30/1994	11/30/1994	0		OTH	OTH	zovirax		codeine causes blurry vision	~ ()~~~In patient	CO5745	1						1	Chest pain; Chills; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082163	11/29/1995	WA	63.0	63		F	09/20/1995	pt recvd vax; thick, heavy, induration over site, malaise, lack of appetite, weight loss; on pred for poss mercury rxn & on ATB for poss infect;				Y					N	11/16/1994	11/18/1994	2		PVT	UNK	none stated	none	allergy to pcn, halcion, prozac & tape;	~ ()~~~In patient	CO5750	1						1	Anorexia; Injection site mass; Malaise; Weight decreased	FLU3~CONNAUGHT LABORATORIES~4F51069~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082164	11/29/1995	VA	69.0	69		F	09/20/1995	pt recvd vax; throat felt raw, tongue, mouth & lips swollen, eyes bulging, diff breathing & anxiety				Y					Y	11/28/1994	11/28/1994	0		PUB	OTH	none	none	allergic to shell fish	~ ()~~~In patient	CO5752	1						1	Anxiety; Dyspnoea; Eye disorder; Face oedema; Pharyngitis; Tongue oedema	FLU3~CONNAUGHT LABORATORIES~4F51158~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082165	11/29/1995	CA	84.0	84		M	09/20/1995	pt recvd vax; Bell's palsy; f/u: partially recovered w/ tx of pred;				Y					N	11/15/1994	11/24/1994	9		PVT	PVT	insulin, cardura, glucotrol, vasoted	none	serologic evidence of past infect w/ hep C	none~ ()~~~In patient	CO5754	1						1	Facial palsy	FLU3~CONNAUGHT LABORATORIES~4F51085~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082166	11/29/1995	FL				M	09/20/1995	pt recvd vax;labyrinthitis w/ sx like benign positional vertigo;subjective sx of imbalance w/ limitation;neurologic exam nl;														UNK	UNK				~ ()~~~In patient	CO5755	1						1	Coordination abnormal; Gait disturbance; Hypotonia; Vertigo; Vestibular disorder	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082167	11/29/1995	AZ	7.0	7		M	09/20/1995	urticaria rash along the rt & lt side of trunk;no wheezing or resp sx;treated w/Atarax & resolved w/in 24hrs;				Y					Y	11/28/1994	11/29/1994	1		PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	CO5760	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51165~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082170	11/29/1995	NY	50.0			M	09/20/1995	pt recvd vax & pain in back in rt arm & then devel pins & needles sensation about 2 wks p/inj;nothing significant on neuro exam				Y					N					OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	CO5767	1						1	Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082171	11/29/1995	NJ	3.0	3		M	09/20/1995	edema in the injected arm from elbow to shoulder,extending into the anterior part of the chest devel 2 days p/inj;treated w/ATB									Y	11/06/1994	11/08/1994	2		PVT	PVT	unk	NONE	NONE	NONE~ ()~~~In patient	CO5769	1						1	Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082172	11/29/1995	CT	45.0	45		M	09/20/1995	pt recvd pain in shoulder & arm muscle which is annoying;has gotten no better, no worse since time of inj				Y					N	11/04/1994	11/11/1994	7		OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	CO5770	1						1	Injection site pain; Myalgia	FLU3~CONNAUGHT LABORATORIES~4F51085~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082173	11/29/1995	NY				F	09/20/1995	localized erythema w/8-10cm of induration;resolving				Y					Y	12/06/1994	12/07/1994	1		PVT	OTH	NONE	unkE	NONE	NONE-flu vax in past w/o problem~ ()~~~In patient	CO5773	1						1	Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082198	11/29/1995	PA				U	09/20/1995	pt recvd vax; local rxn, probably due to SC administration									U					UNK	UNK				~ ()~~~In patient	CO5776	1						1	Injection site reaction	FLU3~CONNAUGHT LABORATORIES~4F51072~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082199	11/29/1995	PA				F	09/20/1995	local reaction;believed dose given SC;									U					UNK	UNK				~ ()~~~In patient	CO5777	1						1	Injection site reaction	FLU3~CONNAUGHT LABORATORIES~4F51023~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082200	11/29/1995	PA				F	09/20/1995	4cm erythematous local reaction									Y					UNK	UNK				~ ()~~~In patient	CO5778	1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~4F51023~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082201	11/29/1995	PA				F	09/20/1995	local reaction & secondary adenitis									U					UNK	UNK				~ ()~~~In patient	CO5779	1						1	Injection site reaction; Lymphadenopathy	FLU3~CONNAUGHT LABORATORIES~4F51023~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082202	11/29/1995	FL	28.0			F	09/20/1995	immed anaphylactic-like rxn w/dizziness,tightness of chest,finger nails turned blue w/assoc urticaria w/in 45mins of inj;tx w/DPH & IV steroids;11NOV94 rash on chest & abd;no diff swallowing or breathing;				Y					Y	11/11/1994	11/11/1994	0		OTH	OTH		NONE	allergy to milk;cholingergic urticaria	NONE~ ()~~~In patient	CO5781	1						1	Anaphylactoid reaction; Chest pain; Cyanosis; Dizziness; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082203	11/29/1995	OH	50.0	49		M	09/20/1995	rash on neck & upper chest;treated w/pred w/resolution,but reoccurred p/stopping steroid;flu shots in the past w/o problem;2FEB95 biopsy 24NOV94 mast consistent w/papular urticaria;				Y					U	09/30/1994	10/01/1994	1		PUB	OTH	Tenorim	NONE	HTN	pt exp flu vax in the past w/o problem~ ()~~~In patient	CO5782	1						1	Rash maculo-papular; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51079~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082206	11/29/1995	CA	46.0	45		F	09/20/1995	arm pain radiating to shoulder;no local rxn;pain not severe;treated w/PT for 1month & NSAID w/o improvement;has limited range of motion;no sensory deficit;1FEB95 f/u MRI can 24JAN95 showed localized rxn in bone @ inj site;				Y					U	10/28/1994	10/28/1994	0		PVT	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	CO5790	1						1	Hypokinesia; Injection site reaction; Pain	FLU3~CONNAUGHT LABORATORIES~4F51015~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082207	11/29/1995	NJ	38.0			F	09/20/1995	urticaria p/flu shot in OCT94;cont to persist;had rxn w/flu shot yr a/				Y					N					OTH	OTH				pt had rxn w/flu shot yr before~ ()~~~In patient	CO5902	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082208	11/29/1995	MA				F	09/20/1995	chronic fatigue synd w/cognitive changes dx;presents w/numerous sx;has been off work for 6months;workers compensation claim;no details on individual or individual doctor reports;				Y					N					OTH	OTH				~ ()~~~In patient	CO5917	1						1	Asthenia	FLU3~CONNAUGHT LABORATORIES~4F51088~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082683	11/29/1995	PA	56.0	56		F	09/20/1995	terrible rxn as described by pt to nurse;pt seen by neurologist who said nerve in arm compromised but all studies neg;chart indicated vax given in rt arm,but pt states it was the lt arm;25OCT94 f/u pt cont exp pain & paresthesia in lt arm				Y					N	10/12/1993	10/12/1993	0		PVT	OTH	Synthyroid		no allergy history	~ ()~~~In patient	CO5492	1						1	Neuropathy; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~3F41132~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082684	11/29/1995	TX	37.0	37		M	09/20/1995	fine red rash on chest, look flushed;BP 144/98;weak & lightheaded;fine w/in the hr									Y	09/28/1994	09/28/1994	0		OTH	OTH	NONE	NONE	allergy to PCN, rash w/excess OJ	~ ()~~~In patient	CO5570	1						1	Asthenia; Dizziness; Hypertension; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51164~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082685	11/29/1995	MN				F	09/20/1995	nausea,diaphoresis,inc resp,then fainted;911 called,but recovered in about 45sec & was lost to f/u;no other details expected;									Y		09/24/1994			OTH	OTH	unk	unk	unk	~ ()~~~In patient	CO5572	1						1	Hyperhidrosis; Hyperventilation; Nausea; Syncope	FLU3~CONNAUGHT LABORATORIES~4F51159~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082686	11/29/1995	OR	46.0			M	09/20/1995	wheezing,couldn't get breath;seen in ER & given bronchodilator by nebulizer,then discharged;following day had low grade fever & flu-like sx;				Y					Y	09/29/1994	09/29/1994	0		PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	CO5575	1						1	Asthma; Dyspnoea; Influenza; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51015~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082687	11/29/1995	LA	32.0	32		F	09/20/1995	flare-up of lupus condition p/vax;was 1st dx w/lupus p/87 flu vax									U	10/16/1993				MIL	MIL	unk	lupus	lupus	yes~ ()~~~In patient	CO5577	1						1	Condition aggravated	FLU3~CONNAUGHT LABORATORIES~3J41148~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082688	11/29/1995	KY	32.0	32		F	09/20/1995	local rxn w/redness @ site;29NOV94 f/u w/in 24hrs of vax pt had very large approx 2 x 4 rxn;area was warm to touch;there was no pain;no other sign noted;applied ice & cold compresses to area for 24hrs;area stayed red for @ least 5 days									Y	10/04/1994	10/04/1994	0		OTH	OTH	NONE	NONE	NONE	pt recvd flu vax in 1993 w/o problems~ ()~~~In patient	CO5582	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51154~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082689	11/29/1995	FL	13.0			F	09/20/1995	swollen rt arm, warm to touch, sl discolored;also had sore throat;									Y	10/06/1994	10/07/1994	1		PVT	PVT	Ritalin	NONE	no history given	NONE~ ()~~~In patient	CO5594	1						1	Injection site oedema; Pharyngitis; Skin discolouration; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51160~7+~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082690	11/29/1995	GA				F	09/20/1995	severe h/a, lumps in lymph nodes & neck, tingling in finger, hand & arm;									N	10/05/1994	10/06/1994	1		OTH	OTH	unk	none	NONE	~ ()~~~In patient	CO5597	1						1	Headache; Lymphadenopathy; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51158~3~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082712	11/29/1995	CO	51.0	51		F	09/20/1995	tachycardia,face flushed,p94,BP 128/90 (states norm is 90/60),burning & itchy eyes 5-10mins following vax;observed closely for 30mins-P72,BP 120/72,less flushing & less burning;									Y	10/04/1994	10/04/1994	0		OTH	OTH	unk	NONE	asthma	~ ()~~~In patient	CO5599	1						1	Eye disorder; Eye pain; Hypertension; Tachycardia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F51164~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082713	11/29/1995	TX	40.0	40		F	09/20/1995	large local rxn w/numbness on rt side of head & whole lt side of body w/in5mins of vax;treated w/DPH & completely resolved w/in 3 days;									Y	10/07/1994	10/07/1994	0		PVT	UNK	Synthyroid	NONE	no allergy history	NONE~ ()~~~In patient	CO5602	1						1	Injection site reaction; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51074~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082714	11/29/1995	MO	30.0			F	09/20/1995	very warm, legs numb & tingling, heavy, face turned red;was weak & had funny feeling in arm, anxious;took Epi then felt better;									Y	10/10/1994	10/10/1994	0		OTH	OTH				~ ()~~~In patient	CO5604	1						1	Anxiety; Asthenia; Hypoaesthesia; Malaise; Paraesthesia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4F50123~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082715	11/29/1995	NJ	24.0	24		F	09/20/1995	fever & local rxn of pimples on arm;8DEC94 f/u fever 101 evening of inoculation;gone next morning;									Y	10/07/1994	10/08/1994	1		PVT	PVT	NONE	NONE	tinea versicolor	NONE~ ()~~~In patient	CO5607	1						1	Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~4F51158~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082716	11/29/1995		6.0			U	09/20/1995	fever day p/inj in pt which resolved in 24hrs;5 days later devel stiff neck;concerned because used WV instead of SV;neck stiffness is getting better;no other details expected;									U	10/10/1994	10/11/1994	1		OTH	OTH				~ ()~~~In patient	CO5608	1						1	Nuchal rigidity; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082717	11/29/1995	TX	42.0	42		M	09/20/1995	aching in arm, pain in neck & rt side of face red, tender & swollen;eye also swollen, forehead appears bruised;referred to PMD for eval;no other details available;									U	10/14/1994	10/14/1994	0		OTH	OTH	NONE	NONE	high  cholesterol-not treated w/med	NONE~ ()~~~In patient	CO5609	1						1	Ecchymosis; Face oedema; Myalgia; Neck pain; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082718	11/29/1995	MI	24.0			F	09/20/1995	sore arm, lightheadedness, chest tightness, palpitations, weakness;able to finish work shift & drive home;slept awhile;by next evening feeling better;able to work									Y	10/07/1994	10/08/1994	1		OTH	OTH				~ ()~~~In patient	CO5610	1						1	Asthenia; Chest pain; Dizziness; Myalgia; Palpitations	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082719	11/29/1995	TX				M	09/20/1995	chills,temp,flu-like sx;									U	10/14/1994	10/15/1994	1		OTH	OTH				~ ()~~~In patient	CO5611	1						1	Chills; Influenza; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51011~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082720	11/29/1995	TX				M	09/20/1995	flu like sx;off work for 4 days;									U					OTH	OTH				~ ()~~~In patient	CO5612	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~4F51011~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082721	11/29/1995	WI	48.0	48		F	09/20/1995	blotches on hands & arms,sl tightness on breathing approx 30mins p/inj;treated w/epi @ hosp ER w/? other Iv meds;				Y					U	10/13/1994	10/13/1994	0		OTH	PVT	Tegratol	NONE	epilepsy	NONE~ ()~~~In patient	CO5614	1						1	Chest pain; Rash	FLU3~CONNAUGHT LABORATORIES~4F51023~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082722	11/29/1995	WI	34.0	34		F	09/20/1995	felt weak, faint, diaphoretic & pale approx 5 mins p/inj;seen in ER:				Y					U	10/12/1994	10/12/1994	0		OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient	CO5615	1						1	Asthenia; Hyperhidrosis; Pallor; Syncope	FLU3~CONNAUGHT LABORATORIES~4F51023~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082723	11/29/1995	OR	76.0			F	09/20/1995	rash, raised & bright red hives on arms & inner thighs & back of legs;fever 101 & achy;									U	10/12/1994	10/15/1994	3		UNK	UNK				~ ()~~~In patient	CO5616	1						1	Myalgia; Pyrexia; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51165~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082724	11/29/1995	MO	59.0	59		F	09/20/1995	dizzy, headache, pain between shoulder blade, nausea, abd pain & weakness;									U	10/17/1994	10/17/1994	0		UNK	UNK				~ ()~~~In patient	CO5618	1						1	Abdominal pain; Asthenia; Dizziness; Headache; Nausea; Pain	FLU3~CONNAUGHT LABORATORIES~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082725	11/29/1995	OK				F	09/20/1995	drop foot, poss GBS				Y					U					UNK	UNK				~ ()~~~In patient	CO5619	1						1	Guillain-Barre syndrome; Peroneal nerve palsy	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082726	11/29/1995	NY				F	09/20/1995	terrible chills about 4hrs then fever;started about 12hrs p/inj;									U	10/17/1994	10/17/1994	0		PVT	PVT				~ ()~~~In patient	CO5620	1						1	Chills; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51133~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082727	11/29/1995	NC	42.0	42		F	09/20/1995	arm hurting immed p/inj,later could hardly move arm;then just stopped & next morning woke up w/ h/a & vomiting;6FEB95 f/u had vomiting for 8hrs;treated w/phenergan supp & resolved;									Y	10/18/1994	10/18/1994	0		OTH	OTH	Lanoxin	no illness	MVP, allergy to codinen	pt exp mild local discomfort~ ()~~~In patient	CO5621	1						1	Headache; Hypokinesia; Pain; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51010~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082728	11/29/1995	NC	24.0	24		M	09/20/1995	fever 100.4 & other flu like sx;1FEB95 f/u had sx for 12hrs;treated w/Ibuprofen x2 & resolved;									Y	10/18/1994	10/19/1994	1		OTH	OTH	NONE	sinus congestion, but no acute s/s ill	allergy to ASA	NONE~ ()~~~In patient	CO5623	1						1	Influenza; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51010~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082730	11/29/1995	NJ	60.0	60		F	09/20/1995	hives on wrist, then all over w/in 4hrs p/inj;seen in ER				Y					Y	10/11/1994	10/11/1994	0		OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	CO5626	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51023~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082731	11/29/1995	WI	46.0	46		F	09/20/1995	lower extremity joint pains & achy feeling;									U	10/14/1994	10/17/1994	3		OTH	OTH	NONE	NONE	Nallergy to dust, pollen & mold	~ ()~~~In patient	CO5627	1						1	Arthralgia; Myalgia	FLU3~CONNAUGHT LABORATORIES~4F51023~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082778	11/29/1995	MI	41.0			F	09/20/1995	pt recvd vax; SOB, heavy chest, coughing & sneezing; observed for 3hr at clinic; tx w/ inhaler				Y					Y	10/18/1994	10/18/1994	0		OTH	OTH	none			~ ()~~~In patient	CO5632	1						1	Chest pain; Cough; Dyspnoea; Rhinitis	FLU3~CONNAUGHT LABORATORIES~4F51010~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082779	11/29/1995	WA				F	09/20/1995	pt recvd vax;local rxn in deltoid that was red & hot;hand started to swell & redness devel in the antecubital area & was assoc w/ petechiae on arm;sed rate moderately elev;no inc in WBC;				Y					U					UNK	UNK				~ ()~~~In patient	CO5635	1						1	Injection site hypersensitivity; Oedema peripheral; Petechiae; Red blood cell sedimentation rate increased; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082782	11/29/1995	NY	64.0			F	09/20/1995	pt recvd vax; itching, asthma flared up, then angioedema of the lips 24 hrs p/ vax;									Y	10/18/1994	10/18/1994	0		OTH	OTH				~ ()~~~In patient	CO5639	1						1	Angioneurotic oedema; Asthma; Condition aggravated; Pruritus	FLU3~CONNAUGHT LABORATORIES~4F51085~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082785	11/29/1995	IN	34.0	34		F	09/20/1995	pt recvd vax;heaviness in chest,some diff breathing;14dec94 f/u: also had dry non productive cough,rt side of throat closed up,achiness,conjunctivitis (green discharge from eyes);fever of 102;tx at md's ofc;				Y					Y	10/26/1994	10/26/1994	0		PUB	PUB			no hx of egg allergy	~ ()~~~In patient	CO5643	1						1	Chest pain; Conjunctivitis; Cough; Dyspnoea; Laryngospasm; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4F51154~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082786	11/29/1995	NM	33.0			F	09/20/1995	face swollen w/herpetic lesions on nose & chin;treated w/Atarax & steroids;6DEC94 f/u recovered;				Y					Y	10/21/1994	10/22/1994	1		PVT	PVT	Parfon forte	just having problems w/muscle spasm	no egg allergies	NONE~ ()~~~In patient	CO5644	1						1	Dermatitis bullous; Face oedema	FLU3~CONNAUGHT LABORATORIES~4F51015~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082788	11/29/1995	PA	46.0	46		F	09/20/1995	h/a w/cramps in feet & calves following by vomiting for 7hrs;swelling @ site;									Y	10/19/1994	10/20/1994	1		OTH	OTH	Theophylline	NONE	asthma	~ ()~~~In patient	CO5647	1						1	Headache; Injection site oedema; Muscle spasms; Vomiting	FLU3~CONNAUGHT LABORATORIES~4F51026~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082789	11/29/1995	MO	66.0	66		F	09/20/1995	gen muscle pain & aches on 19OCT94, took ASA on 20OCT94 w/relief;25OCT94 cont to have muscular pain, but relieved by ASA;no other complaints;									U	10/17/1994	10/19/1994	2		OTH	PVT	Hydrochlorthrophin	NONE	hx of high BP	NONE~ ()~~~In patient	CO5649	1						1	Myalgia	FLU3~CONNAUGHT LABORATORIES~4F51023~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082790	11/29/1995	KY	27.0	27		F	09/20/1995	itching all over;treated w/DPH & resolved;									Y	10/28/1994	10/28/1994	0		PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	CO5655	1						1	Pruritus	FLU3~CONNAUGHT LABORATORIES~4F51026~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082791	11/29/1995		80.0			F	09/20/1995	nausea, & vomiting;feeling terrible;no other details provided;did not want to fill out forms;				Y					U					OTH	OTH				~ ()~~~In patient	CO5656	1						1	Malaise; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0082793	11/29/1995	WI	18.0	18		M	09/20/1995	low grade fever,then unilateral posterior & anterior cervical lymph nodes on inj site side;no other sx;				Y					U	10/27/1994	10/28/1994	1		OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	CO5659	1						1	Lymphadenopathy; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082794	11/29/1995	PA	45.0			M	09/20/1995	soreness @ site & deltoid area,then progressed to include neck & into eye;15OCT94 went to ER & was treated w/Motrin & DPH;to MD sometime later who took pt off meds because pt is on Pred for arthritis;was given unk type of med by MD;				Y					N	10/12/1994	10/12/1994	0		OTH	OTH	Pred	NONE	arthritis being treated w/Pred	~ ()~~~In patient	CO5660	1						1	Eye pain; Injection site pain; Neck pain	FLU3~CONNAUGHT LABORATORIES~4F51132~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082795	11/29/1995	CA	76.0	76		F	09/20/1995	tingling & sl burning sensation & abn taste in mouth,then numbness on the lt side of face,not including forehead;seen on 31OCT94 & condition was stable as described;no motor deficit,only sensory;no local sx or other systemic;				Y					Y	10/28/1994	10/30/1994	2		OTH	OTH	Mevacor, provental, esturase	NONE	hypecholestrimia, asthma	NONE~ ()~~~In patient	CO5663	1						1	Dysgeusia; Hypoaesthesia; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082796	11/29/1995	MO	43.0	42		F	09/20/1995	swelling in groin & face w/mouth sores & lymphadenopathy on same side as inj;pt in the past w/o problems;treated w/DPH;				Y					U	10/28/1994	10/31/1994	3		UNK	UNK	Estrogen replacement			~ ()~~~In patient	CO5667	1						1	Face oedema; Lymphadenopathy; Oedema	FLU3~CONNAUGHT LABORATORIES~4F51129~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082797	11/29/1995	MA	42.0	42		M	09/20/1995	puffy face about 6hrs p/vax;treated w/DPH;no local rxn				Y					U	11/02/1994	11/02/1994	0		OTH	OTH	NONE	NONE	allergy to nuts	NONE~ ()~~~In patient	CO5668	1						1	Face oedema	FLU3~CONNAUGHT LABORATORIES~4F51025~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082798	11/29/1995	CA	56.0	56		M	09/20/1995	w/in a few hrs devel sl dry irritating cough w/face & lip swelling, achiness, chills & fatigue;lasted a few hrs & started to resolved;flu shot in past w/o problem									Y	11/01/1994	11/01/1994	0		OTH	OTH		NONE	allergic rhinitis & asthma as a youth	NONE~ ()~~~In patient	CO5669	1						1	Asthenia; Chills; Cough; Face oedema; Myalgia	FLU3~CONNAUGHT LABORATORIES~4F51072~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082799	11/29/1995	VA	45.0	45		M	09/20/1995	burning pain in lt flank;onset 1 hr p/vax;subsided w/in 48hrs;									Y	11/01/1994	11/01/1994	0		OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	CO5671	1						1	Injection site pain	FLU3~CONNAUGHT LABORATORIES~~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082800	11/29/1995	NY				M	09/20/1995	red,indurated area w/5-10 blebs on rt mid forearm,well below site @ 24hrs;seen by occupational nurse 27OCT & 29OCT;29OCT94 rash had spread to lt arm & abd;referred to family MD for further treatment;				Y					U	10/26/1994	10/27/1994	1		OTH	OTH				~ ()~~~In patient	CO5672	1						1	Rash; Skin nodule	FLU3~CONNAUGHT LABORATORIES~4F51132~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082801	11/29/1995	MI	50.0			F	09/20/1995	SOB, inc heart rate, raspy & hoarse w/in 3hrs of vax;no treatment needed;resolved									Y	10/18/1994	10/18/1994	0		PUB	OTH		NONE	unk	NONE~ ()~~~In patient	CO5673	1						1	Dysphonia; Dyspnoea; Tachycardia	FLU3~CONNAUGHT LABORATORIES~4F51024~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082802	11/29/1995	GA	62.0	61		M	09/20/1995	cold-like sx,dull h/a,swollen lip;stayed in urgent care from 635PM to 730PM;				Y					Y	11/04/1994	11/04/1994	0		PUB	OTH	synthroid, kalin sh for BP	NONE	HTN, hypothyroid, no allergies	NONE~ ()~~~In patient	CO5674	1						1	Face oedema; Headache; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082803	11/29/1995	SC	81.0			F	09/20/1995	very sick as described by pt;not seen;pt claimed to have B12 shot mixed w/vax,but no record of vitamin administered;@ time of inj,c/o nausea & was given dramamine & observed for 2hrs then discharged to home;pt called stating almost died;									Y	10/18/1994	10/18/1994	0		PVT	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	CO5675	1						1	Malaise; Nausea	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082804	11/29/1995	IL	5.0			M	09/20/1995	fever of 102 w/in 6hrs, also h/a lasting 2 days;									Y					PVT	UNK				~ ()~~~In patient	CO5676	1						1	Headache; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082805	11/29/1995	MO	26.0	26		F	09/20/1995											09/26/1994				OTH	OTH		NONE	allergy to bees	NONE~ ()~~~In patient	CO5677	1						1	Injection site atrophy; Pain	FLU3~CONNAUGHT LABORATORIES~4F51164~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082806	11/29/1995	IN	53.0	53		F	09/20/1995	2 episodes of dizziness;1st episode 2hrs p/vax lasting 30seconds,2nd event about 10hrs later lasting about 10 seconds;no other sx;									Y	11/04/1994	11/04/1994	0		OTH	OTH	unk	NONE	NONE	NONE~ ()~~~In patient	CO5679	1						1	Dizziness	FLU3~CONNAUGHT LABORATORIES~4F51165~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082808	11/29/1995	WA	63.0	63		F	09/20/1995	exacerbation of lt facial paralysis 3 days p/vax;was in recovery phase of Bell's palsy of unk etiology when recvd vax;hx of rheumatoid arthritis & diabetes;f/u no improvement p/2wks;tx steroids & acyclovir for suspected virus reactivation;				Y					N	10/24/1994	10/27/1994	3	MRI nl;	OTH	OTH	steroids, methotreate, oral diabetic medication	bells palsy	rheumatoid arthritis, diabetes	pt exp initial facial paralysis devel w/in days of prev flu vax approx 1 yr ago~ ()~~~In patient	CO5684	1						1	Facial palsy	FLU3~CONNAUGHT LABORATORIES~~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082811	11/29/1995	CT	39.0	39		F	09/20/1995	paresthesia of 4 & 5th digits of rt hand w/tender non-palpable axillary lymph node;30NOV94 f/u paresthesia resolved on 12NOV94 rt axillary tenderness resolved 15NOV94;				Y					Y	11/09/1994	11/10/1994	1		PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	CO5689	1						1	Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F51015~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082813	11/29/1995	NJ	49.0	49		F	09/20/1995	immed lt shoulder pain radiating to lt neck;while driving home approx 1/2 hr later had dizzy spell & tachycardia;pain still very noticeable in arms & neck;15mins p/1st episode had another similar;took DPH;fine later in evening;only soreness									Y	11/10/1994	11/10/1994	0		PVT	PVT	low dose estrogen, progesterone	NONE	NONE	NONE~ ()~~~In patient	CO5691	1						1	Dizziness; Neck pain; Pain; Tachycardia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082814	11/29/1995	MT	42.0			F	09/20/1995	breathing diff,tightness in chest w/wheezing w/in 4hrs of vax;tx w/breathing treatment & IV DPH & Pred;				Y					Y	11/09/1994	11/09/1994	0		OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	CO5695	1						1	Asthma; Chest pain; Dyspnoea	FLU3~CONNAUGHT LABORATORIES~4F51072~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082815	11/29/1995	NY	43.0	43		F	09/20/1995	immed hive @ inj site;took DPH & topical cortisone cream;some chest tightness about 4hrs later; resolved;only some soreness as of 15NOV94;									Y	11/14/1994	11/14/1994	0		PVT	PVT	unk	NONE	dust & mold allergy	NONE~ ()~~~In patient	CO5698	1						1	Chest pain; Injection site hypersensitivity; Myalgia	FLU3~CONNAUGHT LABORATORIES~4F51010~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082816	11/29/1995	CT	39.0	39		M	09/20/1995	hives noc of the shot that gradually evolved over entire body;took DPH;									Y	11/02/1994	11/02/1994	0		OTH	OTH	NONE	NONE	childhood problem w/hawaiian punch;no other allergy hx	pt recvd flu shot in the past w/o problem~ ()~~~In patient	CO5699	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~4F51129~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082817	11/29/1995	IL	82.0			M	09/20/1995	muscle weakness in both legs 4 days p/vax;pt seen by neurologist who does not feel these sx are an adverse rxn;pt having MRI,EMG & CAT scan to r/o poss CVA;				Y					U	10/17/1994	10/24/1994	7	pt to have MRI, EMG, CAT to r/o poss CVA	PUB	OTH	vasotec, lasix	NONE	unk	~ ()~~~In patient	CO5701	1						1	Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~4F51016~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0082818	11/29/1995	MA	44.0	44		F	09/20/1995	edema of feet & legs;1st notice this in evening @ supper;only sl swelling the following morning;no other sx;									U	11/15/1994	11/15/1994	0		OTH	OTH	Cardura, Naprosyn	NONE	HTN	pt recvd flu vax in the past w/o problem~ ()~~~In patient	CO5704	1						1	Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~4F51025~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082819	11/29/1995	NY	63.0	62		F	09/20/1995	pain in neck & upper back 2 days p/inj;eyes sensitive to light,sl malaise;pain radiated down arms & settled in elbows;seen on 17NOV94 & pain still persists;				Y					Y	10/31/1994	11/02/1994	2		OTH	OTH				~ ()~~~In patient	CO5705	1						1	Arthralgia; Back pain; Malaise; Neck pain; Pain; Photosensitivity reaction	FLU3~CONNAUGHT LABORATORIES~4F51079~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0079762	11/30/1995	PA	75.0			F	11/22/1995	pt recvd vax NOV95 & 1wk p/vax devel muscle weakness;pt was hospitalized for 1 wk;testing was performed;sxs persist;MD does not believe that the pt has GBS;This case was reported by pharmacist					Y	7			N	11/01/1995	11/01/1995	0	unk	OTH	OTH	unk		parkinson's disease	~ ()~~~In patient	0010150950285	1						1	Myasthenic syndrome	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0079763	11/30/1995		49.0	49		F	11/30/1995	pt recvd vax & devel Stevens Johnson type rxn p/flu vax;devel facial edema & mouth ulcers;@ time of report pt was recovering;pt had a hx of allergic rxn to bacillus clostridium tetani;			Y						U	10/18/1995	10/18/1995	0		OTH	MIL	Thyroxine tabs; Omeprazole; Tibolone, Iburpofen	NONE	allergic rxn to Bacillus Clostridium Tetani		REG95480	1						1	Face oedema; Mouth ulceration; Stevens-Johnson syndrome	FLU3~MEDEVA PHARMA, LTD.~E52281D91~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening	Influenza
0079768	11/30/1995	MI	28.0	28		F	11/07/1995	w/in 3mins of inj & climbing one flight of stairs pt devel dry heaves, dizziness, light headedness & flushing;pt sat down for 10mins, the came back to area where recvd vax, neg for all sxs x/upset stomach;sent to ER & monitored for 1 hr				Y					Y	11/01/1995	11/01/1995	0	NONE	PVT	PVT	Doxycycline	3min	cervical infection after D&C on ATB for 5 days	~ ()~~~In patient		1						1	Dizziness; Dyspepsia; Vasodilatation; Vomiting	FLU3~PFIZER\WYETH~4958084~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0079769	11/30/1995	MD	80.0	80		M	11/01/1995	c/o nasal congestion on 18OCT that proceeded to chest congestion w/productive cough over the next couple of days;chest pain started on 25OCT95 & has been intermittent since taking NTG w/some relief				Y					N	10/18/1995	10/18/1995	0		PUB	PUB	Cardizem, Klor-con, Lanoxin, Furosemide, Propanolo	NONE	MI, open heart suregy, prostate CA, orchiectomy	pt exp bad cold w/flu vax Q year;~ ()~~~In patient	MD95041	1						1	Chest pain; Cough; Lung disorder; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61120~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1076B~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0079771	11/30/1995	IL	66.0	66		F	11/13/1995	27OCT95 itching follow by raised rash on arm thigh & waist 13NOV95 rash spread to chest, breast & back;used cortisone cream 9NOV95;started on Saldane BID on 13NOV95; still has rash				Y					U	10/10/1995	10/27/1995	17	NONE	PUB	PUB	Synthroid	NONE	allergic to sun	NONE~ ()~~~In patient	IL950129	1						1	Pruritus; Rash; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~5F61148~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0151B~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0079777	11/30/1995	NY	68.0	68		M	11/23/1995	flu like sxs-chills-fever-chest pain-weakness;went to MD prescribed Doxycycine									Y	10/30/1995	11/06/1995	7		PUB	OTH		NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Chest pain; Chills; Influenza; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079779	11/30/1995	OH				M	11/22/1995	pt recvd flu vax-rash on trunk, abd, upper extremities									Y	10/13/1995				MIL	MIL		schrizophrenia	NKA	~ ()~~~In patient		1						1	Rash	FLU3~PFIZER\WYETH~4958141~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079785	11/30/1995	MD	67.0	66		F	11/01/1995	pt c/o violent shakes from 730PM-930PM on 25OCT95did not check temp									Y	10/25/1995	10/25/1995	0		PUB	PUB	HCTZ, Reserpine	NONE	Hypertension	~ ()~~~In patient	MD95042	1						1	Tremor	FLU3~CONNAUGHT LABORATORIES~5F61120~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079788	11/30/1995	GA	36.0	36		F	11/21/1995	103 temp, weak, achy, nauseated, 101 temp for @ least 4 days;bad cough 99 to 100 temp									N	11/15/1995	11/15/1995	0	NONE	OTH	PUB	NONE	NONE	hay fever	NONE~ ()~~~In patient		1						1	Asthenia; Cough; Myalgia; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079792	12/01/1995	MA	32.0	32		F	11/17/1995	fever 104, joint pain neck, spine, arms, legs, chills-redness, swelling @ inj sites; rx w/Pred 17NOV95; adm to hosp 18NOV, dx cellulitis lt arm rx IV ATB (Vancomycin discharged 19NOV;				Y	Y	2			Y	11/07/1995	11/08/1995	1		PUB	UNK		NONE	NONE	pt's sib recvd PPV vax in '95 & devel ARDS, hosp x4mon, rec w/side effects.~ ()~~~In patient	MA9530	1						1	Arthralgia; Cellulitis; Chills; Injection site hypersensitivity; Injection site oedema; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61134~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~394962~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0079796	12/01/1995	OR	40.0	40		M	10/26/1995	muscle soreness began a few hrs p/inj;pt discovered about 1wk later had dec strength lt arm;pt able to quantify this as lifts weights on a regular basis;began to notice tingling, esp thumb & fore finger lt hand				Y					N	10/05/1995	10/05/1995	0	NONE	PVT	PVT	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Asthenia; Myalgia; Paraesthesia	FLU3~PFIZER\WYETH~4958075~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~5F1086~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0079801	12/01/1995	ID	40.0	40		M	11/22/1995	pain in joint of rt elbow 1 hr p/inj & cont to get worse for a wk;spread to lt elbow for 3 days;rt elbow appear to be improving slowly but still painful									N	11/14/1995	11/14/1995	0		PVT	PVT		NONE	NONE	NONE~ ()~~~In patient		1						1	Arthralgia	FLU3~PFIZER\WYETH~0848011~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079806	12/01/1995	FL	61.0	61		F	10/20/1995	pt c/o redness swelling, pain to  lt arm;also states arm is hard to touch & hot									Y	10/19/1995	10/19/1995	0	NONE	OTH	PUB	Axid & propolsid	NONE	gastric reflux	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4958124~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079808	12/01/1995	OH	79.0	79		F	11/25/1995	broke out badly from shoulders to hip bones front & back-later seen private area; called emergency clinic recommended DPH; burning red on breasts-welts all over red from shoulder to pelvic area;									Y	10/24/1995	10/26/1995	2		UNK	UNK	Synthroid	NONE	NONE	~ ()~~~In patient		1						1	Rash; Urticaria; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079809	12/01/1995	FL	34.0	34		F	11/29/1995	the morning p/shot given pt awoke w/pain in rt arm, & rt hand was swollen;also ahd severe pain in rt foot & foot was swollen;also generalized aches & pains;pt seen in ER evening, the evening of shot had some SOB.				Y					Y	11/09/1995	11/09/1995	0	NONE	PUB	PUB	NONE	NONE	dogs, cats, pollen-allergies	~ ()~~~In patient	FL95088	1						1	Dyspnoea; Myalgia; Oedema peripheral; Pain	FLU3~CONNAUGHT LABORATORIES~5F61134~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0080593	12/01/1995	WY	18.0	18		F	10/27/1995	10mins p/vax pt c/o itching @ inj site;had 6cm redness, 2cm induration;reported itching getting increasingly worse;DPH given;10mins p/DPH itching & induration resolved, redness fading;10 mins later pt ambulated from office w/rxn resolved;									Y	10/27/1995	10/27/1995	0		PUB	PUB		NONE		~ ()~~~In patient	WY9524	1						1	Injection site hypersensitivity; Injection site mass; Pruritus	FLU3~PFIZER\WYETH~4958117~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079820	12/04/1995	PA	40.0	40		F	10/23/1995	total body rash, swelling of nasal passages, swelling of throat-ER tx included IV Solumedrol 125mg;IV DPH;IV Pepcid;Epi;Tagamet, Pred;sx included local swelling, redness, itch @ site			Y	Y					Y	10/16/1995	10/18/1995	2	NA	PVT	PVT	NA	NONE	seasonal allergies	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Laryngospasm; Pruritus; Rash; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61100~3~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0079822	12/04/1995	GA	33.0	33		F	10/18/1995	fever 100-104;started late in evening on 5OCT95;had myalgia, arthralgia, nausea & vomiting on 6OCT95;started having cellulitis in vax area on 7OCT;had trouble moving arm, chills, severe h/a, stiff neck by late 7OCT; went to ER				Y	Y	1			Y	10/05/1995	10/05/1995	0	CBC, electrolytes, UA, CXR	PUB	PUB	Oral contraceptives	NONE	NONE	~ ()~~~In patient	GA95192	1						1	Arthralgia; Cellulitis; Chills; Hypokinesia; Myalgia; Nausea; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~4958114~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1558A~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0079823	12/04/1995	WY	43.0	43		F	11/20/1995	prolong pain in lt arm of inj-to date 4 wks;pain is worse @ noc, also terrible lying on rt side;pain so bad on sitting especially in chairs w/arm rest;pain inc on activity eg getting dressed, putting on deoderant, reaching w/lt rm;				Y						10/23/1995	10/23/1995	0	MRI-inconclusive but suggestive of shoulder impingement;MD don't agree but strongly feel it is directly on indirectly related to flu inj;pain started p/flu vax	PVT	OTH	Thyroid	mild URI	hypothyroid	pt exp pain in arm @ 42 w/flu vax & exp similar rxn to tetanus x 1 wk~ ()~~~In patient		1						1	Hypokinesia; Pain	FLU3~PFIZER\WYETH~4958078~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0079824	12/04/1995	TN	1.9	1	.9	F	11/28/1995	fever 104.7-febrile sz x 2 went to ER;28OCT95 seen in office by primary care peds;MD states no evidence of acute illness today				Y					Y	11/27/1995	11/27/1995	0	blood culture, UA, strept screens, chem panels all neg in hosp	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Febrile convulsion; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E2835HE~1~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0079825	12/04/1995	PA	59.0	58		M	11/22/1995	15NOV p/vax devel flu like sxs achiness, fever;16NOV numbness in legs 17NOV no feeling in legs;adm to hosp;18NOV no feeling in hands or fingers;unable to walk;dx GBS;30NOV still in hosp, sl feeling in toes, still unable to walk;tired & weak					Y	12			U	11/02/1995	11/14/1995	12		OTH	OTH	Procardia;ASA	NONE		NONE~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome; Hypoaesthesia; Hypokinesia; Influenza; Myalgia; Myasthenic syndrome; Pyrexia; Asthenia; Guillain-Barre syndrome; Hypokinesia; Influenza; Myalgia; Paraesthesia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61144~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~5F61144~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0079830	12/04/1995	GA	41.0	41		F		pt recvd vax 25OCT95 & reddened area appear next day around site of inj;travelled around side of arm;many red streaks & one large red area on ? deltoid toward arm pit;blood poison; sore				Y						10/25/1995	10/26/1995	1	No tests done	OTH	PVT	Relatin, Beconase inhaler	NONE	allergies-environmental/no pre rxn	~ ()~~~In patient		1						1	Infection; Injection site hypersensitivity; Myalgia; Skin striae; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~4~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0079833	12/04/1995	GA	33.0	33		F	10/29/1995	pt recvd vax 5OCT95;approx 48hrs p/vax resp problems which thought to be bronchitis;has hx of asthma;started OTC cold med &Amoxicillin but devel T,chills,noc sweats,cough &severe SOB w/lethargy;to ER;CXR show rt lobe pneumonia w/atelectasis				Y					Y	10/05/1995	10/07/1995	2	CXR	PUB	PUB	Lortab, Asthma inhaler, SOma, Voharen	NONE	hx asthma & occasional bronchitis	~ ()~~~In patient	GA95193	1						1	Atelectasis; Bronchitis; Chills; Dyspnoea; Hyperhidrosis; Pneumonia; Pyrexia; Somnolence	FLU3~PFIZER\WYETH~4958114~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1558A~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0079834	12/04/1995	VA	5.0	5		F	11/29/1995	24hrs p/vax pt notified mom that lt upper arm was red;									Y	11/22/1995	11/24/1995	2		PUB	PUB	NONE	NONE	asthma;rash to ceclor	~ ()~~~In patient	VA95086	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~01185P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0079835	12/04/1995	WY	13.0	13		M	11/08/1995	flu vax administered lt deltoid 3:55 26OCT95; 4:20 pale, diaphoretic, weak nauseated; BP 80/64, AP 48; given DPH;4:25 skin warm, not as diaphoretic; 4:30 cheek pink, no diaphoresis, able to amublate without assistance, nausea gone;BP 88/64									Y	10/26/1995	10/26/1995	0		PUB	PUB	NONE	well	denied	~ ()~~~In patient	WY9525	1						1	Asthenia; Bradycardia; Hyperhidrosis; Hypotension; Nausea; Pallor; Vasodilatation	FLU3~PFIZER\WYETH~4958117~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079837	12/04/1995	MO	42.0	42		F	11/28/1995	w/in an hr, arm became swollen, red @ site, & very painful;inc in intensity for 36hrs; arm became difficult to use;bruising approx 3 x 4 @ site;									Y	11/15/1995	11/15/1995	0		OTH	OTH	NONE	NONE	allergic to ASA, Erythromycin & codeine	~ ()~~~In patient		1						1	Ecchymosis; Hypokinesia; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4958234~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079839	12/04/1995	WI	63.0	63		F	11/27/1995	48 hrs p/vax pt had 7 cm warm, hard, reddened area @ site of inj									Y	11/07/1995	11/09/1995	2	NONE	PVT	PVT	NA	NONE		~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~PFIZER\WYETH~4958121~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079841	12/04/1995	WA	52.0	52		M	11/21/1995	68mm reddened area; inc heat noted induration present									Y	11/17/1995	11/20/1995	3	NONE	OTH	OTH	Cozoar	NONE	HTN	NONE~ ()~~~In patient		1						1	Skin nodule; Vasodilatation	FLU3~PARKE-DAVIS~01595P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0079846	12/04/1995	MT	58.0	58		F		started w/eating diff & tongue problems w/h/a on 9OCT; temp & chills;10OCT lt side face couldn't close eye & numbness-rx in ED dx Bell's palsy cause unk				Y					U	10/06/1995	10/08/1995	2		UNK	UNK	Estrogen, Progesterin	NONE	NONE	pt exp rxn @ 15yrs w/flu vax~ ()~~~In patient		1						1	Anorexia; Chills; Facial palsy; Headache; Paraesthesia; Pyrexia; Tongue disorder	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0079847	12/04/1995	NV	55.0	55		F	10/11/1995	numbness & tingling rt arm & hand & down leg & face-tightness tingling intermittant x 2 wks;mostly rt side-1 day in lt hand									U	10/01/1995	10/01/1995	0		OTH	OTH	Provera, Premarin			NONE~ ()~~~In patient		1						1	Paraesthesia	FLU3~CONNAUGHT LABORATORIES~5F61167~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079848	12/04/1995	TX	60.0	60		M	10/30/1995	pt recvd vax & 48hrs later devel itching on chest, abd, neck & arms;some redness sl rash chlorstrinta x 2 no relief-will try longer time									U	10/25/1995	10/27/1995	2		OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Pruritus; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0079849	12/04/1995	TX	50.0	50		M	10/30/1995	devel hives, redness on face, neck & chest 1 day p/vax flu vax also h/a;tx DPH;									U	10/28/1995	10/30/1995	2		OTH	OTH	NONE	NONE	allergies	nONE~ ()~~~In patient		1						1	Headache; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61166~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079850	12/04/1995	CA	32.0	32		F	10/18/1995	nausea rt p/vax;rash all over body in AM; will take DPH po									U	10/17/1995	10/18/1995	1		UNK	UNK	BCP, vit		hypoglycerin	NONE~ ()~~~In patient		1						1	Nausea; Rash	FLU3~CONNAUGHT LABORATORIES~5F61167~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079852	12/04/1995	CO	43.0	43		M	11/27/1995	sore arm, w/shooting pain up & down arm-pt has tired ice & advil-pain has dec but pain has cont										11/11/1995	11/13/1995	2	NONE	OTH	PUB	NONE	NONE	rt ventricular defeat	~ ()~~~In patient		1						1	Pain	FLU3~CONNAUGHT LABORATORIES~5F61168~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079853	12/04/1995	CO	22.0	22		M	10/11/1995	1000 recvd inj @ work-some redness-no heat @ inj site-round small red bumps (4 @ shot area-5 on forearm rt arm) (2-3 bumps on lt arm); no itching;									U	10/11/1995	10/11/1995	0	NONE	PUB	PVT	NONE	NONE	hx of hives-AUG95-3wks	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Rash	FLU3~CONNAUGHT LABORATORIES~5F61144~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079854	12/04/1995	CO	66.0	66		F	10/27/1995	pt recvd vax 18OCT;arm swollen (lt upper) red, very sore 2 days later;p/10 days pt c/o arm still being sore;will be out of town x 4 days & will contact if not improved by then;advised to see MD if necessary									U	10/18/1995	10/20/1995	2	NONE	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Oedema; Pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079857	12/04/1995	CO	65.0	65		F	10/19/1995	pt recvd vax 16OCT95 & 17OCT95 12noon c/o h/a & nausea;took ASA; In the evening, began to vomit & c/o msucle aches;19OCT95 c/o some h/a but is up ad lib;pt has exp similar rxn w/prev flu vax									Y	10/16/1995	10/17/1995	1		PUB	PUB	Synthroid;Premarin;Provera	NONE	NONE	pt exp similar rxn w/2 prev flu vax~ ()~~~In patient	CO95058	1						1	Headache; Myalgia; Nausea; Vomiting	FLU3~PFIZER\WYETH~4958140~3~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079858	12/04/1995	CO	38.0	38		F	10/19/1995	pt recvd vax 17OCT sxs morning of 18OCT nausea & vomiting p/eating breakfast, body aches, fatigue improved throughout day, still has lt sided joint pain;took ASA helped w/body aches									Y	10/17/1995	10/18/1995	1	NA	PUB	PUB	Thyroid med	NONE	NA	NA~ ()~~~In patient	CO95057	1						1	Asthenia; Myalgia; Nausea; Pain; Vomiting	FLU3~PFIZER\WYETH~4958140~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079813	12/05/1995	OH	75.0	75		M	11/27/1995	pt recvd vax & was hospitalized from 17NOV95 to 19NOV95 for Guillain Barre Synd (dec reflexes, paralysis in lower extremities & arms & hands), vomiting & dizziness;these sxs were reversed in 36 hrs w/steroid therapy;					Y	3			Y	11/16/1995	11/17/1995	1	NONE	PVT	OTH	K-Dur		hx of HTN	~ ()~~~In patient	0010150950286	1						1	Dizziness; Guillain-Barre syndrome; Hypotonia; Paralysis; Vomiting	FLU3~PARKE-DAVIS~02065P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0079863	12/05/1995	PA	70.0			M	12/01/1995	pt recvd flu vax & was observed x 30mins then sent home;@ the time of vax pt denied allergies;later that noc felt distressed & went to the ER dx sepsis was made;reporter states pt died that day p/being seen in ER;	Y	09/25/1995		Y	Y				N	09/24/1995	09/25/1995	1	NONE	OTH	OTH	unk	NONE	NONE	~ ()~~~In patient	ALI95493	1						1	Malaise; Sepsis	FLU3~MEDEVA PHARMA, LTD.~E2835HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0079868	12/06/1995	MD	70.0			M	11/09/1995	pt recvd flu vax & 2 days later presented w/jaundice & was hospitalized for workup of poss cholestasis;PT underwent liver biopsy, but results are unk;				Y	Y	6			U	11/01/1995			9NOV95 liver biopsy results unk;	OTH	OTH	unk	unk	unk	NA~ ()~~~In patient	895317012L	1						1	Cholangitis; Gastrointestinal disorder; Hepatic cirrhosis; Hepatic function abnormal; Hepatitis; Jaundice; Laboratory test abnormal; Sepsis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0079869	12/06/1995	CA	52.0			M	11/14/1995	pt recvd vax & 7 to 10 days later pt was admitted to hosp w/temp of 105;underwent workup for pneumonis including culture & biopsy which are neg so far;condition has worsened & is in the ICU as of the date of this report;				Y	Y	7			U	10/28/1995	11/07/1995	10	culture neg; biopsy neg;	OTH	OTH	Azulfidine	unk	pt has regional enteritis treated w/azulfidine	~ ()~~~In patient	895325006L	1						1	Pneumonia; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0079870	12/06/1995	OH	58.0	58		F	12/04/1995	devel mild paralysis & numbness in legs 3-4 days p/vax;hospitalized 1 wk w/dx of transverse myelitis;had inc in CSF protein;1DEC95 still has urinary incontenence & needs wheelchair for mobility;internist dx was post vax encephalomyelitis;				Y	Y	7			U	10/26/1995	10/29/1995	3		OTH	OTH			past hx of breast CA in 1992, hx of depression	~ ()~~~In patient	CO6377	1						1	CSF test abnormal; Encephalitis; Hypokinesia; Myelitis; Paraesthesia; Paralysis; Urinary incontinence; Anorectal disorder; Back pain; Hypokinesia; Pain; Paraesthesia; Urinary incontinence; Back pain; CSF test abnormal; Hypokinesia; Paraesthesia; Urinary incontinence; Back pain; Encephalitis; Hypokinesia; Myelitis; Pain; Paraesthesia; Urinary incontinence	FLU3~CONNAUGHT LABORATORIES~5F61133~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~5F61133~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~5F61133~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~4|FLU3~CONNAUGHT LABORATORIES~5F61133~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~5	USA	Hospitalisation	Influenza
0079890	12/07/1995	CA	37.0	37		M	11/07/1995	lightheaded & faint;went to ER was not hospitalized;middle chest & stomach, felt like having a heart attack				Y					Y	10/30/1995	11/02/1995	3	7NOV95 called to pt MD thinks its gallstones	OTH	PVT				~ ()~~~In patient		1						1	Chest pain; Dizziness; Syncope	FLU3~PFIZER\WYETH~4958124~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0079892	12/07/1995	WA	11.0	11		M	11/07/1995	<1 hr of vax, c/o chilling;devel fever that eve of 104;APAP x2-t103;next day had intermittent LE numbness w/weakness vs feeling like on fire in thighs & calves;no resp involvement lasted 2 days;last few months has had diff w/allergy				Y					Y	11/01/1995	11/01/1995	0	dx w/pneumonia 3 days later by family MD;	PUB	PUB	Clariton;Inhalers;Tylaid, Beclovent;Proventil	denies	severe asthma 38 allergins not eggs; migraines 1-2x/mo	denies has had all recommended~ ()~~~In patient	WA951189	1						1	Chills; Myasthenic syndrome; Pain; Paraesthesia; Pneumonia; Pyrexia; Thyroid disorder	FLU3~PFIZER\WYETH~4958119~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0079894	12/07/1995	CA	58.0	58		F	11/13/1995	devel flu like sx i.e. h/a, achiness on Thursday;arm swelled from area of shot down & around the inner arm;devel red welts on underside very sore				Y					Y	10/25/1995	10/26/1995	1	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	CA95152	1						1	Headache; Influenza; Injection site oedema; Myalgia; Oedema peripheral; Urticaria	FLU3~PFIZER\WYETH~4958151~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0415A~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0079895	12/07/1995	CA	71.0	71		M	11/06/1995	2NOV95 12 given began to get achy muscles on 3NOV95;5NOV95 began to shake had vomiting & diarrhea;went to ER which got a shot				Y					Y	11/02/1995	11/03/1995	1		PUB	PUB	Lo pressor;Diuretic	NONE	HTN	~ ()~~~In patient	CA95151	1						1	Diarrhoea; Myalgia; Tremor; Vomiting	FLU3~PFIZER\WYETH~4958136~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0079896	12/07/1995	CA	50.0			F	11/06/1995	pt w/myelodysplasia w/chronic low WBC, RBC & platelet counts got permission from MD to take flu shot;next day called to say vaccinated arm was red & swollen shoulder to wrist;referred to MD sent to urgent care placed on ATB for staph cellus				Y					Y	10/31/1995	11/01/1995	1	WBC (prior to vax 2,100 plat 11,000;	PVT	PUB		myelodysplasia (chronic)	myelodysplasis (chronic)	~ ()~~~In patient	CA95149	1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4958151~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0079897	12/07/1995	CA	39.0	39		F	11/09/1995	pt c/o SOB; dyspnea inc to need for 911 cal to ER given INIS & breathing tx observed for 2-3hrs & released;10 days later 27OCT had virus w/cough;ER dx 17OCT95 bronchospasm r/o rxn to flu vax;allerg to avacado & PCN type med				Y					Y	10/17/1995	10/17/1995	0	EKG nl	PUB	PUB	NONE	NONE	hx asthmatic bronchitis (19 yrs ago)	~ ()~~~In patient	CA95145	1						1	Asthma; Cough; Dyspnoea	FLU3~CONNAUGHT LABORATORIES~5F61120~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0079898	12/07/1995	CA	51.0	51		M	11/10/1995	rt arm, large local rxn (about 12cm marked swelling & induration), fever to 105 for 36 hrs, chills, myalgias;				Y					Y	10/31/1995	10/31/1995	0	CBC, VIA, LFT's, influenza acute serology drawn	PVT	PUB	INterferon, 5 million units 3x wk;Procardia	pt has hepatitis C on interferon	HTN, pt has Hep C on interferon	~ ()~~~In patient	CA95146	1						1	Chills; Injection site reaction; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4958151~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1076B~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0079901	12/07/1995	CA	40.0			F	11/07/1995	sleeping poorly, Saturday nite, dizzy still feeling dizzy														OTH	PVT	NA	NA		~ ()~~~In patient		1						1	Dizziness; Insomnia	FLU3~MEDEVA PHARMA, LTD.~E2805HC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0079902	12/07/1995	CA	57.0	57		M	11/21/1995	3NOV-10NOV sore throat;18NOV c/o h/a;19NOV buzzing in head, has effected hearing;21NOV to MD h/a, dizziness, heavy head;										11/03/1995	11/10/1995	7	ears clear, checked eyes;no rx, take advil for pain	OTH	PVT	APAP	denies	denies	~ ()~~~In patient		1						1	Deafness; Eye pain; Headache; Pharyngitis; Tinnitus	FLU3~MEDEVA PHARMA, LTD.~E2805HC~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0079903	12/07/1995	MI	43.0	43		M	12/05/1995	12 hrs p/vax pt devel severe cramping in both legs;was able to work for 2 or 3 days; CPK 12,700;serum myoglobin 1700;									Y	10/28/1995	10/28/1995	0	CK 12,700;myoglobin 1700	OTH	UNK		NONE	NONE	NONE~ ()~~~In patient		1						1	Muscle spasms	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079906	12/07/1995	CA	6.0	5		F	11/14/1995	1:40 pt fel faint lowered self to floor;1:45 BP 92/62, P72, R20 skin cool clammy alert awake; 1:55 BP 118/62, P84, R16 juice given @ pts request walk to chair; 2:10 BP 118/62, P72;2:25 BP 100/78 walked around mall;2:40 BP 118/80;2:45 feelse									Y	11/04/1995	11/04/1995	0		OTH	PVT		NONE		~ ()~~~In patient		1						1	Hyperhidrosis; Hypotension; Syncope	FLU3~MEDEVA PHARMA, LTD.~E2805HC~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0079907	12/07/1995	WA	3.0	3		F	11/03/1995	3NOV95 about 1 1/2hrs p/vax mom of pt called & reported some rash on the pt's behing legs;some coughing episdoe;MD's office contacted;rash/hives appeared per mom;									Y	11/03/1995	11/03/1995	0		PUB	PUB				~ ()~~~In patient	WA951183	1						1	Cough; Rash; Urticaria	FLU3~PFIZER\WYETH~4958139~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079909	12/07/1995	WA	59.0	59		F	11/21/1995	pt c/o red 2-3 spot (round on lt arm @ inj site; no fever hurts off & on; was swollen but not now 21NOV & is lighter in color now suggest;hot packs & pain if necessary;									U	11/15/1995	11/16/1995	1	has had 2 prev flu shots w/o problems	PUB	PUB		NONE	kidney problem; an rx hurt was an when had other flu doses	NONE~ ()~~~In patient	WA951185	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4958125~3~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079910	12/07/1995	WA	55.0	55		F	11/16/1995	severe rxn to flu shot on 11NOV95 c/o sore throat, & felt awful, fever, draggy feeling,vomiting, h/a, bronchitis type cough, nasal draining (lots);cont until 14NOV95; pt is convinced above sxs from flu vax									Y	11/08/1995	11/11/1995	3		UNK	UNK		NONE	NONE	NA~ ()~~~In patient	WA951186	1						1	Asthenia; Bronchitis; Cough; Headache; Pharyngitis; Pyrexia; Rhinitis; Vomiting	FLU3~PFIZER\WYETH~4958113~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079913	12/07/1995	CA	59.0	59		F	11/20/1995	pt woke up w/sore neck behind the rt ear, pain felt radiating to shoulder area & could not lift head off pillow on 10NOV95;neck felt hot but denies fever;Took Ibuprofen 3 tabs q 4 hrs on 11NOV95 & placed ice pack on neck;									Y	11/09/1995	11/10/1995	1		PUB	PUB				~ ()~~~In patient	CA95155	1						1	Hypokinesia; Myalgia; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4958151~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079874	12/08/1995	AZ	31.0	31		F	12/01/1995	24hrs p/vax pt began gen pruritus;seen 48hrs following vax more severe pruritus, skin erythema w/o dysphagia				Y					Y	11/29/1995	11/30/1995	1	DPH; Solumedrol;IVP	PUB	PVT		NONE	NONE	~ ()~~~In patient		1						1	Dysphagia; Pruritus; Rash	FLU3~PFIZER\WYETH~4958077~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|MMR~MERCK & CO. INC.~0211B~1~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0079877	12/08/1995	MI	61.0	61		F	11/09/1995	7NOV95 devel red blotches & rash over body, hands were extremely itchy-no temp BP 155/65 some achiness; called MD who advised cortisone cream;denies allergies prev known;had flu shots prev yrs & no rxn;										11/06/1995	11/07/1995	1		PUB	PUB		NONE		~ ()~~~In patient	MI95138	1						1	Myalgia; Pruritus; Rash; Rash maculo-papular	FLU3~PFIZER\WYETH~4958138~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079881	12/08/1995	MI	55.0	55		M	11/29/1995	11NOV95 tingling in hands-sensitivity to hot/cold, dec strength in hands;16NO95 using cane leg weakness;seen by chiropractor x 2;17NOV95 seen by MD tested reflex:none, resp function 2-25 adm to hosp LP done GBS dx'd;			Y	Y	Y				N	10/31/1995	11/10/1995	10	17NOV95 LP;20NOV95 EMG-confirmed GBS;glucose 65; protein 54; CSF GM stain no organisms seen no cells seen;CXR	PUB	PUB	NONE	URI x 1 wk a/vaccine given;	polio as a child rt leg compeltely-lt leg moderately	~ ()~~~In patient	MI95144	1						1	Asthenia; CSF test abnormal; Guillain-Barre syndrome; Myasthenic syndrome; Neuropathy; Paraesthesia	FLU3~PFIZER\WYETH~4958129~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0079882	12/08/1995	TN	84.0	84		F	10/23/1995	adm to hosp w/lethargy, inc temp, diarrhea, anorexia;also hypokalemic, orthostatic hypotension;adm for rehydration, given Kcl, IV's, APAP final dx'd was krohn's disease surgery required 29NOV95 pt still hospitalized				Y	Y	38			N	10/13/1995	10/14/1995	1		PUB	PUB	Mycelin	NONE	tremors (not parkinson's)	~ ()~~~In patient	TN95123	1						1	Anorexia; Dehydration; Diarrhoea; Hypokalaemia; Ileitis; Pyrexia; Somnolence	FLU3~CONNAUGHT LABORATORIES~5F61126~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0079884	12/08/1995	TN	54.0	54		F	11/14/1995	the next morning awoke w/severe sore throat which lasted 2 days & progressed to head & chest congestion;6 days p/inj devel a migraine which eventually led to hospitalization for treatment w/Demerol;MD said was allergic to the flu shot				Y	Y	1			Y	11/03/1995	11/04/1995	1		PUB	PUB	Inderal, Estratab	history of migraines	migraines	~ ()~~~In patient	TN95125	1						1	Hypersensitivity; Lung disorder; Migraine; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61126~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0079543	12/11/1995	NM	31.0	31		F	11/15/1995	pt recvd vax & immed rxn of erythema @ site of inj radiating to shoulder;pt c/o pins & needles, shakiness & anxiety;given Epi;pt cont c/o dizziness, numbness of extremities, claminess;BP 158/64, P90, R22;transport to ER-SOB & tightness thro				Y					Y	11/15/1995	11/15/1995	0		PVT	PVT	NONE	denies	reports sensitivity to medications	~ ()~~~In patient		1						2	Anxiety; Dizziness; Dyspnoea; Hypoaesthesia; Injection site hypersensitivity; Laryngospasm; Paraesthesia; Tremor; Anxiety; Dizziness; Dyspnoea; Hypoaesthesia; Injection site hypersensitivity; Laryngospasm; Paraesthesia; Tremor; Dizziness; Dyspnoea; Hyperhidrosis; Hypoaesthesia; Injection site hypersensitivity; Laryngospasm; Paraesthesia; Tremor	FLU3~PFIZER\WYETH~4958089~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4958089~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|FLU3~PFIZER\WYETH~4958089~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~3	USA	Emergency room visit	Influenza
0079930	12/11/1995	MT	75.0	75		M	10/27/1995	devel fever & chills 22OCT95 became disoriented; hospitalized w/inc WBC, ATB given;					Y	5			Y	10/17/1995	10/22/1995	5		OTH	PUB		NONE	diabetes	~ ()~~~In patient	MT95016	1						1	Chills; Confusional state; Diabetes mellitus; Leukocytosis; Peripheral vascular disorder; Pyrexia; Skin ulcer	FLU3~CONNAUGHT LABORATORIES~5J61007~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0079936	12/11/1995	MD	59.0	59		F	12/09/1995	head congested/chest congested;sore throat-green phlegm in nose									N	12/04/1995	12/05/1995	1	NONE	PUB	PUB	Kelefin	NONE	seldane allergy	NA~ ()~~~In patient	MD95054	1						1	Lung disorder; Pharyngitis; Rhinitis; Sinusitis	FLU3~PARKE-DAVIS~00785P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0079937	12/11/1995	MD	63.0	63		M	12/09/1995	day post vax-sore throat;chest congested-coughing up green phlegm;										12/04/1995	12/05/1995	1	NONE	PUB	PUB	Precardia;Penthroyd	NONE	diabetes, high BP, PCN, Seldane, allergy	NA~ ()~~~In patient	MD95055	1						1	Cough; Lung disorder; Pharyngitis	FLU3~PARKE-DAVIS~00785P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0079941	12/11/1995	NY	60.0	60		M	12/07/1995	Guillain-Barre synd									N	11/17/1995	11/30/1995	13	diagnostic spinal tap	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Guillain-Barre syndrome; Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~5F61113~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~5F61113~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0079942	12/11/1995	MS				F	10/23/1995	immed @ inj site, pt had hard, swollen area, tender to touch 23OCT;area still tender 2NOV;					Y					10/23/1995				UNK	UNK			NONE	~ ()~~~In patient		1						1	Injection site mass; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4958110~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0079943	12/11/1995	PA	58.0			M	11/22/1995	pt recvd flu vax 12NOV95 @ work;14NOV began to have flu-like sxs aches, pains all over head/neck/extremeties;+ fever-100;felt warm w/chills;16NOV weakness began in lower extremities + tingling, numbness;17NOV could not walk;19NOV inc weak					Y					11/12/1995	11/17/1995	5	CSF fluid neg organism; pos protein 161;	UNK	UNK			PMH, CABG-1991;hyperlipidemia;colon CA-removed	~ ()~~~In patient		1						1	Arthralgia; CSF test abnormal; Hypoaesthesia; Hypokinesia; Myalgia; Myasthenic syndrome; Paraesthesia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0079945	12/11/1995	IA	59.0	59		F		myalgias, fever, chills, leukopenia & thrombocytopenia;					Y	3			Y	11/04/1995	11/04/1995	0	WBC 2200, platelet 82,000;	UNK	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Chills; Leukopenia; Myalgia; Pyrexia; Thrombocytopenia; Arthralgia; Asthenia; Chills; Injection site oedema; Injection site pain; Laboratory test abnormal; Malaise; Pyrexia	FLU3~PFIZER\WYETH~4958067~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4958067~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0079946	12/11/1995	IL	46.0	46		M	11/20/1995	pt recvd vax 26OCT denies fever, no localized rxn, devel rash groin area, which progressed stomach & back;seen by MD 3x & family given cortisone inj w/improvement of rash; pt denied any allergy to eggs-able to eat eggs in baked/cooked foods				Y					Y	10/26/1995	10/30/1995	4	NONE	PUB	PUB		NNE	NONE	~ ()~~~In patient	IL950131	1						1	Rash	FLU3~CONNAUGHT LABORATORIES~5F61149~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0079948	12/11/1995	OK	48.0	48		F	11/28/1995	hands, feet itching, burning, became fiery red, numbness in lips, fine rash over body;occurred 30-40mins p/vax;seen by MD, DPH caps x 2 & DPH inj; Medrol dose pack started				Y					Y	11/20/1995	11/20/1995	0	NONE	PVT	PVT	premarin	NONE	NONE	NONE~ ()~~~In patient	OK9544	1						1	Pain; Paraesthesia; Pruritus; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61096~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0079951	12/11/1995	NC	39.0			F	11/03/1995	diffuse erythema, numbness of tongue, teeth & gums about 15mins p/vax; also devel severe itching, chest tightness, nausea & h/a;				Y						10/31/1995	10/31/1995	0		UNK	UNK	Maxair, Tenormin		seasonal allergies;allerg to PCN, contrast media, hx asthma;	~ ()~~~In patient		1						1	Chest pain; Headache; Nausea; Paraesthesia oral; Pruritus; Rash	FLU3~PFIZER\WYETH~4958072~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0079968	12/11/1995	WA	74.0	74		F	12/06/1995	6NOV95 given flu vax @ MD's office;7NOV95 sever aching of every bone of body, muscular soreness of lt deltoid area;9NOV95 mod diarrhea;									Y	11/06/1995	11/07/1995	1	NONE	PVT	PVT	Diabeta, Prilosec	diabetic type II	diabetic type ii, inflamation of eosphagus & stomach, moderate BP	NONE~ ()~~~In patient		1						1	Bone pain; Diarrhoea; Myalgia	FLU3~PFIZER\WYETH~4958112~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079970	12/11/1995		55.0	55		F	11/26/1995	pt recvd vax 1OCT95 & few hrs later there was a numbing sensations;started @ inj site, the numbing sensation spread form rt side of body to let side, the numbing sensation was also affecting the rectal, vaginal, breast areas;saw MD										10/01/1995	10/01/1995	0		UNK	UNK				~ ()~~~In patient		1						1	Paraesthesia	FLU3~CONNAUGHT LABORATORIES~5F61135~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079972	12/11/1995	CO	33.0	33		F	11/17/1995	2 red, warm hard area @ site of flu vax										11/16/1995	11/17/1995	1	NA	UNK	UNK	NA		NKA	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079973	12/11/1995	MS	33.0	32		F		immed p/vax pt had anaphylactic rxn requiring hosp visit, Epi & solumedrol;pt had flushing to top of head, then disorientation & unresponsiveness;w/in 3-4 minutes pt experienced swelling, SOB, & blanching of skin; Epi given & to hosp					Y					10/23/1995	10/23/1995	0		UNK	UNK				~ ()~~~In patient		1						1	Anaphylactoid reaction; Confusional state; Dyspnoea; Oedema peripheral; Pallor; Stupor; Vasodilatation	FLU3~PFIZER\WYETH~4958110~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0079926	12/12/1995	NY	52.0	52		F	12/04/1995	pt recvd vax & became weak instructed to sit in waiting room for 10-20 mins for observation;called later in day w/report of 2 1/2 diameter reddened area;no swelling;no SOB;if worse report to ER									Y	12/01/1995	12/01/1995	0		PVT	UNK		Menepausal sxs;	pt states eggs go right through pt but insisted on getting vax;	~ ()~~~In patient		1						1	Asthenia; Vasodilatation	FLU3~PFIZER\WYETH~4958113~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079995	12/13/1995	AK	43.0	43		F	11/13/1995	4NOV95 1030 recvd vax & 5NOV95 0200 nausea, flushed, weak & h/a;0330 leg cramping, worse h/a,nausea/weakness;0335 gen tonic rxn, clenched teeth, posturing, x 72sec w/o incontinence;positive postictal;h/a, nausea, weakness lasted 1wk				Y	Y	1			Y	11/04/1995	11/05/1995	1	NL CBC, NL chem 24, sl low magnesium	MIL	MIL	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Asthenia; Convulsion; Headache; Hypertonia; Nausea; Stupor; Urinary incontinence; Vasodilatation	FLU3~PFIZER\WYETH~4958207~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TYP~PFIZER\WYETH~4948189~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0080003	12/13/1995	TX	54.0	54		M	12/08/1995	rt brachial plexus neuropathy-sensory & motor loss radial & ulnar nerves;severe incapacitating pain rt upper extremity;hypertension				Y					N	10/06/1995	11/06/1995	31	MRI-nl	PVT	PVT	synthroid;micronase;colucoprage	adult onset diabests	hypothyroidism p/I 131 for Graves dis	~ ()~~~In patient		1						1	Hypertension; Hypokinesia; Myasthenic syndrome; Neuropathy; Pain; Paraesthesia	FLU3~PARKE-DAVIS~00975P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~UNKNOWN MANUFACTURER~~1~~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0080004	12/13/1995	NC	41.0	41		M	12/07/1995	h/a constant t100 constant malaise, discomfort, muscle drawing in rt arm, shoulder & back, immobile problems hand wrist arm, numbness, tingling, stiffness, cont facial muscles, problems w/breathing;				Y					N	11/22/1995	11/23/1995	1		UNK	OTH	NONE	NONE	NONE/asthma	NONE~ ()~~~In patient	NC96006	1						1	Arthralgia; Dyspnoea; Hypertonia; Hypoaesthesia; Hypotonia; Malaise; Paraesthesia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TTOX~CONNAUGHT LABORATORIES~4928127183~1~~RA~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0080008	12/13/1995	MO	10.0	10		M	11/30/1995	c/o tingling lt wrist to below 10mins p/vax; returned to hlth dept;no swelling or discoloration @ inj site;no itching;No SOB;on way home 10mins later c/o SOB;mom called ambulance;To ER				Y					Y	11/09/1995	11/09/1995	0	NONE	PUB	PUB	Ventolin & Intal inhalers BID; allergy shots q 2 wks	NA	allergic child, asthmatic	NA~ ()~~~In patient		1						1	Dyspnoea; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~5F61099~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0080009	12/13/1995	MI	80.0	80		F	10/30/1995	about 7mins p/vax pt started feeling numb in arms & legs w/nausea & sl chest tightness;also c/o some lightheadedness;denies any itching;pt had eaten breakfast;pt was not nervous about receiving vax;									Y	10/31/1995	10/31/1995	0		PUB	PUB	ASA; Theodor, Dyazide, tenex, nitro patch	NONE	has asthma & coronary artery disease;allergies to iodine dye, sulfa, brethine treimix, macrodantin, erythromycin	~ ()~~~In patient	MI95150	1						1	Chest pain; Dizziness; Hypoaesthesia; Nausea	FLU3~PFIZER\WYETH~4958151~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0080010	12/13/1995	MI	42.0	42		F	10/24/1995	pt recvd vax 3PM on 23OCT95 @ around 9PM was not feeling well, heart rate inc sl itching of arms, chest area;around MN had inc itching & rash on arms, hands, inc HR & apprehension;no noted SOB; also quite warm & then had chills;									Y	10/23/1995	10/23/1995	0	NA	PUB	PUB	had taken echinocea for a sore throat;	NONE	allergies to PCN, erthromycin, vancomycin	~ ()~~~In patient	MI95149	1						1	Anxiety; Chills; Malaise; Pruritus; Pyrexia; Rash; Tachycardia	FLU3~PFIZER\WYETH~4958151~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0080016	12/13/1995	PA	51.0	51		F	12/01/1995	extreme pain in face, jaw, neck, head; fever, chills, cough, swollen glands, sinus congestion, nausea;stiffness in jaw & neck, backache				Y					Y	11/09/1995	11/12/1995	3	NONE	MIL	OTH		sl cold		~ ()~~~In patient		1						1	Chills; Cough; Hypertonia; Lymphadenopathy; Nausea; Neck pain; Pyrexia; Sinusitis	FLU3~PFIZER\WYETH~4958207~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0080017	12/13/1995	TX	42.0	42		F	11/27/1995	25OCT94 neck, shoulder pain;28OCT94 flu-like sx-fatigue, h/a, neck & shoulder pain;31OCT94 returned to hosp-shoulder & neck pain, fatigue-put on Darvocet N-100 & Amoxicillin; 1NOV94 to ER for tingling & parasthesias in upper extremities				Y					N	10/18/1994	10/25/1994	7	1NOV94 CBC ? WBC elevated?;15NOV94 CT scan, 14NOV94 CXR; 1NOV95 UA (all nl or neg)	PVT	PVT	Micronor	NONE	healthy-never had problems w/back or shoulders prior to vax	~ ()~~~In patient		1						1	Asthenia; Headache; Hypoaesthesia; Hypotonia; Influenza; Neck pain; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4948117~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0080025	12/13/1995	VA	20.0	20		F	11/30/1995	17NOV95 severe h/a lessening on 18NOV95 & 19NOV95 & 19NOV95-20NOV95 dizziness;sxs gone 20NOV95;									Y	11/16/1995	11/17/1995	1	NONE	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Dizziness; Headache	FLU3~PFIZER\WYETH~4958140~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEPA~SMITHKLINE BEECHAM~VHA440A6~1~IM A~~HEP A (HAVRIX)~1	USA		Influenza
0080026	12/13/1995	WI	48.0	48		F	12/04/1995	pt called stated 18hrs p/vax started itching head to toe-unable to sleep d/t itch; no hive									Y	11/08/1995	11/09/1995	1	septa allergy, PCN allergy;	PVT	UNK	NONE		allergy Septa, PCN;	~ ()~~~In patient		1						1	Pruritus	FLU3~PFIZER\WYETH~4958138~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0080028	12/13/1995	NJ	35.0	35		F	11/19/1995	pt recvd vax on 17OCT95 & devel tongue numbness on 21OCT95;pt recvd PPD on 24OCT95 later that evening eyes were blurry & burning on 29OCT95;had paralysis on the rt side of face;									Y	10/17/1995	10/21/1995	4	MRI-brain-lymes test & ACE level-all neg	OTH	OTH	PPD on 24OCT	NONE	NONE	~ ()~~~In patient		1						1	Eye disorder; Paraesthesia; Paralysis	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~3~~RA~HEP B (NO BRAND NAME)~1	USA		Influenza
0080029	12/13/1995	CA	44.0	44		F	12/05/1995	recurrent hives, wheezing since vax									N	10/01/1995	10/01/1995	0	NONE	PVT	PVT	NONE	NONE	allergy to sulfa & cats	NONE~ ()~~~In patient		1						1	Asthma; Urticaria	FLU3~CONNAUGHT LABORATORIES~5F61015~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0080038	12/13/1995	CA	63.0	63		F	11/11/1995	pt exp redness & edema (2inch by 3inch rectangular) @ edges occuring 2inch below site of vax;intense, sharp demarcated area;									Y	04/25/1995	10/26/1995	184	NONE	PVT	PVT	Premarin;Dyaxide;ASA or Aleve	NONE	erythromycin allergies, osteoarthritis	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~5F61114~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1076B~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0080041	12/13/1995	OH	90.0	90		M	11/30/1995	p/getting flu vax started feeling like had no energy;had same rxn last yr but did not occur until 1wk p/shot & lasted 3 wks;still feeling blah									N	11/03/1995	11/03/1995	0		PUB	UNK		NONE	NONE	pt exp no energy last yr w/flu vax @ 81yo~ ()~~~In patient		1						1	Asthenia; Malaise	FLU3~PFIZER\WYETH~4958137~7+~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0080044	12/13/1995	TX	28.0	28		F	11/30/1995	knot on inj area, very sore onset of same day									Y	11/03/1995	11/03/1995	0		PVT	PVT		sciatica	NONE	~ ()~~~In patient		1						1	Injection site mass; Injection site pain	DT~CONNAUGHT LABORATORIES~5H71142~UNK~~LA~DT ADSORBED (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4958115~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0080047	12/13/1995	MT				M	11/29/1995	chills, shakes;pt given DPH; p/DPH pt felt better;									Y	11/29/1995	11/29/1995	0		MIL	MIL	NA	NA	unk	~ ()~~~In patient		1						1	Chills; Tremor	FLU3~CONNAUGHT LABORATORIES~5F61133~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~PFIZER\WYETH~4958154~1~~LA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0080050	12/13/1995	OH	48.0	48		M	11/21/1995	Bell's Palsy									Y	10/03/1995	11/10/1995	38		PVT	PVT	Insulin Cipro	diabetis mellitus	diabetes mellitus	~ ()~~~In patient		1						1	Facial palsy	FLU3~CONNAUGHT LABORATORIES~5F61166~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~384960~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0080053	12/13/1995	MO	46.0			M	11/29/1995	27NOV95 pt called & stated had broken out in a rash or hives w/in 1 hrs of vax;stated started to itch, skin was red & splotchy but not bumpy or pebbly like hives;took DPH the next day & rash went away;									U				NONE	OTH	PVT	unk	NONE	NONE	unk~ ()~~~In patient		1						1	Pruritus; Rash; Rash maculo-papular; Urticaria	FLU3~PFIZER\WYETH~4958124~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0080054	12/13/1995	FL	54.0	54		U		felt fine p/shot ate oatmeal for breakfast a/that;ate apples & some grapes-lunch;upset stomach 1:45 onset of vomiting 2PM; cont until MN;did not eat any other food that day;vomited to point of dry heaves;accompanied by h/a									Y	11/14/1995	11/14/1995	0	NONE	OTH	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Dyspepsia; Headache; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0079945	12/14/1995	IA	59.0	59		F	11/04/1995	pt recvd vax 4NOV95 & a few hrs later reported that did not feel so good;pt devel local rxn @ the site of vax characterized by swelling & pain;also exp chills, fever & weakness all over body;15NOV95 hospitalized to workup fever & joint pain					Y	3			U	11/04/1995	11/04/1995	0	abnormal blood work (details unk)	PUB	PUB	unk	NONE		~ ()~~~In patient	895331015L	1						2	Chills; Leukopenia; Myalgia; Pyrexia; Thrombocytopenia; Arthralgia; Asthenia; Chills; Injection site oedema; Injection site pain; Laboratory test abnormal; Malaise; Pyrexia	FLU3~PFIZER\WYETH~4958067~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4958067~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0080061	12/14/1995	PA	39.0	39		F	11/02/1995	pt recvd vax 24OCT95 & w/in 24hrs devel cough, nausea, vomiting, extreme weakness (especially in the legs), chest congestion, h/a, muscle aches;pt felt may be getting bronchitis (as pt's son had bronchitis);adm to hosp dx'd pneumonia;				Y	Y	4			Y	10/24/1995	10/26/1995	2	CXR revealed pneumonia in rt mid & rt lower lobes	PUB	OTH	Corgard, Paxil	sl cold sxs	son has bronchitis-pt feels may be coming down w/the same	~ ()~~~In patient	895317001L	1						1	Bronchitis; Cough; Headache; Myalgia; Myasthenic syndrome; Pneumonia; Rhinitis; Vomiting	FLU3~PFIZER\WYETH~4958090~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0080062	12/14/1995	MN	12.0	12		M	11/22/1995	pt recvd vax 13OCT95 & 13NOV95 came home from school early w/t100.6;also c/o gen body aches & chills;15NOV95 presented to MD w/fever of 102.4, chills, sl cough, pain on breathing, aches & leg weakness;unable to stand or walk;hosp dx'd GBS			Y	Y	Y				U	10/13/1995	11/13/1995	31		OTH	PVT	proventil inhaler	NONE	asthma was dx'd in 1992	~ ()~~~In patient	895333004L	1						1	Asthma; Dyspnoea; Guillain-Barre syndrome; Haematuria; Myalgia; Myasthenic syndrome; Pneumonia; Pyrexia	FLU3~PFIZER\WYETH~4958081~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0080063	12/14/1995	CO	61.0	61		M	12/08/1995	adm 22NOV coronary ICU: lung nodule, anemia, rapid progressive ascending motor weakness, GBS			Y	Y	Y				N	11/08/1995	11/21/1995	13	sputum smear positive for AFB 7DEC95; CA of colon	PVT	PVT		unk	unk	~ ()~~~In patient	CO95063	1						1	Anaemia; Guillain-Barre syndrome; Hypotonia; Infection; Lung disorder; Gastrointestinal haemorrhage; Guillain-Barre syndrome; Lung disorder; Microcytic anaemia; Myasthenic syndrome; Neoplasm malignant; Paraesthesia; Paralysis	FLU3~PFIZER\WYETH~4958116~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4958116~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Life Threatening,Hospitalisation	Influenza
0080065	12/14/1995	AZ	70.0	70		F	12/05/1995	8NOV95 pt recvd vax that evening (4-5hrs later) devel hives 9NOV95 took OTC DPH;10NOV95 diffuse arthralgia, 12NOV95 fever, chills & arthralgia, saw PMD 13NOV;also devel red blotches w/hard lumps;to MD w/URI gave Keflex;edema				Y					Y	11/08/1995	11/08/1995	0		PUB	PUB	Lanoxin, Procardia, Lopressor, Alpironal, Premarin, CA-OTC vit E otc	NONE	heart disease-hypertension, gout	NONE~ ()~~~In patient	AZ9532	1						1	Arthralgia; Asthenia; Oedema peripheral; Pharyngitis; Pyrexia; Rash; Skin nodule; Urticaria	FLU3~PFIZER\WYETH~4958120~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0080068	12/14/1995	CO	73.0	73		F	11/27/1995	sore, stiff neck, severe, couldn't raise head off pillow;took ASA x 2 BID for 1 1/2wk;buttocks & upper legs ached-cont;neck began to improve 21NOV;no improved but still cannot fully turn head				Y					U	10/31/1995	11/15/1995	15	xray of both hips results unk	PUB	PUB	NONE	NONE	lt hip sore from long trip	NONE~ ()~~~In patient	CO95061	1						1	Hypokinesia; Myalgia; Neck pain; Nuchal rigidity	FLU3~PARKE-DAVIS~02165P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~390934~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0080071	12/14/1995	AZ	61.0	61		F	11/24/1995	pt recvd vax 120PM pt was very concerned about getting a shot w/ a needle;wanted to use gun;lightheaded dizzy, SOB, very hot, blurred vision, weak in the knees;hyperventilation;									Y	11/15/1995	11/15/1995	0	140PM lt arm 170/70; 150PM 180/84; 2:05 182/90;	PUB	PUB	Premarin	NONE	CA of uterus, breast & skin-pt states all have been resolved w/surgery	NONE~ ()~~~In patient	AZ9531	1						1	Amblyopia; Asthenia; Dizziness; Dyspnoea; Hypertension; Hyperventilation; Vasodilatation	FLU3~PFIZER\WYETH~4958120~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0080072	12/14/1995	MA	76.0	76		F		23OCT95 approx 8PM pt felt fatigued, coughed all noc long;had the chills but no fever; gen malaise; sore throat;h/a, laryngitis;									Y	10/23/1995	10/24/1995	1	NONE	PVT	OTH		NONE		NONE~ ()~~~In patient		1						1	Asthenia; Chills; Cough; Headache; Laryngitis; Malaise; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~5F61134~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0080074	12/14/1995	NM	47.0	47		F	12/08/1995	welts over whole body, x/face lasted one month									Y	11/01/1995	11/03/1995	2	NONE	PUB	UNK	Dilacor, Flexeril, Dyazide, ortho-Novum 777	high BP, fibromyalgia/chronic fatigue sy	allergy dust, mold, mildew, dander; high BP, fibromyalgia/chronic fatigue synd	pt exp vomiting @ 46 w/flu vax~ ()~~~In patient		1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0078092	12/15/1995	NY	56.0	56		M	12/05/1995	pt recvd vax; 12 hrs later p/ vax, pt had cardiac arrest;	Y	09/28/1995							N	09/27/1995	09/28/1995	1	autopsy revealed severe CAD & acute MI;	PVT	UNK	micronase;	none				1						3	Cardiac arrest; Coronary artery disease; Apnoea; Cardiac arrest; Coronary artery disease; Cardiac arrest; Cardiovascular disorder; Diabetes mellitus; Hepatic steatosis; Myocardial infarction; Pancreatitis; Respiratory disorder; Ventricular fibrillation	FLU3~PFIZER\WYETH~4958109~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4958109~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|FLU3~PFIZER\WYETH~4958109~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~3	USA	Results in Death	Influenza
0079825	12/15/1995	PA	59.0	58		M	12/13/1995	pt recvd vax;flu like sxs(achiness,fever) 1 wk p/ vax;16nov95 had numbness in legs;17nov no feeling in legs;adm to hosp;18nov95 no feeling in hands or fingers,unable tp walk;dx GBS;feeling very tired & weak;still in hosp as of 30nov95;					Y				N	11/02/1995	11/04/1995	2		OTH	OTH				~ ()~~~In patient	CO6380	1						2	Asthenia; Guillain-Barre syndrome; Hypoaesthesia; Hypokinesia; Influenza; Myalgia; Myasthenic syndrome; Pyrexia; Asthenia; Guillain-Barre syndrome; Hypokinesia; Influenza; Myalgia; Paraesthesia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61144~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~5F61144~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0079870	12/15/1995	OH	58.0	58		F	12/13/1995	pt recvd vax;back pain,progressive numbness of hips and lower extremities;diff walking,urinary incontinence;to er;suppositive tx, gradual improvement;discharged from hosp 7nov95;				Y	Y	8			N	10/26/1995	10/29/1995	3	MRI brain, spine nl; CSF protein inc;	OTH	PVT	none	none	known hypothyroid condition;	~ ()~~~In patient		1						2	CSF test abnormal; Encephalitis; Hypokinesia; Myelitis; Paraesthesia; Paralysis; Urinary incontinence; Anorectal disorder; Back pain; Hypokinesia; Pain; Paraesthesia; Urinary incontinence; Back pain; CSF test abnormal; Hypokinesia; Paraesthesia; Urinary incontinence; Back pain; Encephalitis; Hypokinesia; Myelitis; Pain; Paraesthesia; Urinary incontinence	FLU3~CONNAUGHT LABORATORIES~5F61133~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~5F61133~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~5F61133~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~4|FLU3~CONNAUGHT LABORATORIES~5F61133~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~5	USA	Hospitalisation	Influenza
0080078	12/15/1995	WA	25.0	25		M	11/03/1995	pt recvd vax;HA,stiff neck,n;aseptic meningitis suspected;lower extremity weakness,urinary incontinence to severe paresis,numbness mid-chest;unable to move legs;weakness upper extremities;dx post infectious immune;myelopathy/radioculopathy;					Y			Y		10/09/1995	10/17/1995	8	WBC's in CSF;	OTH	OTH	none	none	none	none~ ()~~~In patient	WA951190	1						1	CSF test abnormal; Immune system disorder; Infection; Myasthenic syndrome; Myelitis; Neuropathy; Paraesthesia; Paralysis	FLU3~PFIZER\WYETH~4958126~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0080086	12/15/1995	MA	70.0	69		M	12/11/1995	pt recvd vax; fever of 101.6; rash bullous; anemia infectious p/ 12 days; low iron content; linear IgA; fatigue, weakness;					Y	6			N	10/18/1995	10/21/1995	3	r/o lymphoma;	PUB	UNK	hytcin;	none	none	~ ()~~~In patient	MA9534	1						1	Anaemia; Asthenia; Dermatitis bullous; Hyperhidrosis; Hypochromic anaemia; Infection; Pyrexia; Red blood cell sedimentation rate increased	FLU3~CONNAUGHT LABORATORIES~5F61024~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0080091	12/15/1995	MA	54.0	54		F	12/07/1995	lt facial numbness & pressure/pain w/lt lower motor neuron facial nerve palsy;				Y					N	11/20/1995	11/21/1995	1		PUB	OTH	Beconase, Provera, Zantac, Propasid, Estrace, Drixoral, Advil	NONE	no allergies;dx gastroesophageal reflux & perennial non allergic rhinitis	~ ()~~~In patient		1						1	Facial palsy; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4958116~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~428504~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0080093	12/15/1995	MA	52.0	52		F	12/04/1995	48 hrs post vax c/o h/a; 10 days post vax c/o dizzy spells seen @ ER dx vertigo as a result of flu shot				Y					Y	10/18/1995	10/28/1995	10	blood work, EKG	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MA9533	1						1	Dizziness; Headache; Vertigo	FLU3~CONNAUGHT LABORATORIES~5F61134~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1559A~1~IM A~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0080094	12/15/1995	WA	62.0	62		F	11/21/1995	pt recvd vax 14NOV95 & by 6PM intense itching all over-still itching on 17NOV;									U	11/14/1995	11/14/1995	0		PVT	PVT	NONE	NONE	sensitivity to crab	NONE~ ()~~~In patient	WA951182	1						1	Pruritus	FLU3~CONNAUGHT LABORATORIES~5F61126~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0080095	12/15/1995	WA	17.0	17		F	10/27/1995	c/o pain @ time of inj from neck to fingers;very painful since inj site redness w/induration of 2 1/2 hot to touch, not able to use arm;has had flu shot past 5 years w/o problems;										10/25/1995	10/25/1995	0		PUB	PVT		NONE	no problems w/prev 5 flu shots	~ ()~~~In patient	WA951191	1						1	Hypokinesia; Injection site hypersensitivity; Injection site mass; Injection site pain; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4958113~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0080100	12/15/1995	OH	49.0	49		F	11/29/1995	day p/vax arm injected felt like a very bad bruise, then numbness occurred down into hand & fingers w/edema;no discoloration or blanching of skin;no other sxs; pain and swelling disppeared post 9 days;									Y	11/01/1995	11/02/1995	1	NONE	OTH	PUB	NONE	NONE	arthritis in some-joints only	pt had a type of anaphalactic rxn w/old tetanus vax~ ()~~~In patient	OH95164	1						1	Oedema peripheral; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4958111~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0080102	12/15/1995	WA	22.0	22		F	12/11/1995	5mins p/shot onset of hives, arm worse where shot given, across chest-itchy;no swelling, SOB; tx DPH									Y	11/04/1995	11/04/1995	0		PVT	PVT	NONE	NONE	seasonal allergies, Doxycycline, Codeine, Amox	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4958120~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079038	12/18/1995	TX	61.0	61		F	12/11/1995	pt recvd vax;was on intravenous atb;later,same day,c/o mild weakness,right more than lt side;w/in 24 hrs,had suffered complete flaccid paralysis & resp arrest;rt weakness by pm;to ICU;dx of acute motor axonal neuropathy(ANAM);remain in ICU					Y				N	10/23/1995	10/26/1995	3	numerous	MIL	MIL	ciprofloxin, flagyl	diverticulitis		~ ()~~~In patient		1						3	Abdominal pain; Guillain-Barre syndrome; Hypokinesia; Paralysis flaccid; Guillain-Barre syndrome; Abdominal pain; Apnoea; Infection; Leukocytosis; Myasthenic syndrome; Neuropathy; Paralysis	FLU3~CONNAUGHT LABORATORIES~5J61010~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~5J61010~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~5J61010~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Hospitalisation	Influenza
0079941	12/18/1995	NY	60.0	60		M	12/14/1995	pt recvd vax; devel GBS; condition improving as of 7dec95;									U	11/17/1995	11/30/1995	13		PVT	PVT	none	none	none	none~ ()~~~In patient	CO6390	1						2	Guillain-Barre syndrome; Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~5F61113~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~5F61113~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0080107	12/18/1995	ME	58.0	58		F	11/29/1995	pt recvd vax; devel GBS;			Y		Y		Y	Y	U	10/26/1995	11/03/1995	8	inc CSF protein; abnormal neuro condition;	PVT	UNK		bronchitis		~ ()~~~In patient		1						1	CSF test abnormal; Guillain-Barre syndrome; Neuropathy	FLU3~PARKE-DAVIS~01285P~1~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0080108	12/18/1995	WV	45.0	44		F	12/14/1995	pt recvd vax;swollen lt upper arm, pain, low grade T;recvd IV unasym & po augmentin;c/o small air pockets (deltoid abscess) incision & drainage;po cynoflexacin;					Y	6			Y	10/30/1995	10/30/1995	0	tissue culture revealed agrobacterium radiobacter;	OTH	PVT	hydrochlorethiazide/triamterbe thyroid;	none	htn	~ ()~~~In patient		1						1	Abscess; Infection; Injection site oedema; Injection site pain; Myositis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0080110	12/18/1995	NE	33.0	33		F	12/08/1995	pt recvd vax 3NOV95 & 8DEC95 called clinic & reported lt arm & shoulder have been sore ever since receiving flu shot exactly 5 wks to the day 3NOV95;pt cannot lift 5yr old child nor can raise lt arm above head;pain in upper arm & shoulder									U	11/03/1995	11/03/1995	0	NONE	PUB	PUB		NONE	NONE	~ ()~~~In patient		1						1	Hypokinesia; Injection site pain; Pain	FLU3~CONNAUGHT LABORATORIES~5F61144~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0080112	12/18/1995	CA	65.0	65		F	11/17/1995	pt recvd vax & subsequent pain & dec ROM on rt shoulder d/t pain;no sensory or motory strength loss; no documented fever; ESR=60; CPK nl; Xray showed AC joint DJD;clinically most c/w bursitis;				Y					N	10/20/1995	10/21/1995	1	CPK, ESR, xray	OTH	PUB			osteoarthritis, hypertension-no known allergies	~ ()~~~In patient	CA95156	1						1	Arthropathy; Bursitis; Hypokinesia; Injection site pain; Pain; Red blood cell sedimentation rate increased	FLU3~PFIZER\WYETH~4958151~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~UNKNOWN MANUFACTURER~1541A~UNK~IM~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0080113	12/18/1995	CA	61.0	61		M	11/30/1995	food started tasting bad 4 days p/shots;one day later devel extremely sore throat; 10NOV went to acute care given ATB;devel cough on 25NOV95;taste of food has not improved & throat sitll feels strange;lost 30 lbs;				Y					N	11/03/1995	11/07/1995	4		PUB	PUB	med for anxiety & BP	NONE	anxiety attacks-on medication for that & for BP	~ ()~~~In patient	CA95159	1						1	Cough; Dysgeusia; Pharyngitis; Weight decreased	FLU3~PFIZER\WYETH~4958136~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0145A~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0080123	12/18/1995	NV	57.0	57		F	10/18/1995	pt recvd flu vax 12:00; 4:00PM c/o pain in rt arm;cont to worsen;6PM fainted 4 x for an hour or 1/2; c/o heat, perspired, chills & shakey;better 9PM;rt arm, upper arm red & swollen-hot									Y	10/17/1995	10/17/1995	0	NONE	PUB	PUB	arthritis med w/in last mo, Premarin, thyroid	NONE	bordering hypoglycemia;arthritis-many allergies to meds & sensitivity	~ ()~~~In patient	NV95044	1						1	Chills; Hyperhidrosis; Injection site hypersensitivity; Injection site oedema; Pain; Syncope; Tremor; Vasodilatation	FLU3~PARKE-DAVIS~00785P~4~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0080124	12/18/1995	NV	33.0	33		F	11/07/1995	swollen eyelid, whites of eye were red;eyes felt scratchy;eyes were annoying;started 9PM 16OCT until Wed time unk; fever, coughing started 20OCT; pt feels fever-saw MD;rt arm very painful-hit me w/a bat;				Y					Y	10/16/1995	10/16/1995	0	NONE	PUB	PUB	Altenol for cardiac problems	NONE	pollen, airborne, tachycardia	NA~ ()~~~In patient	NV95045	1						1	Conjunctivitis; Cough; Face oedema; Injection site pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0080127	12/18/1995	FL	44.0	44		M	12/11/1995	pt recvd vax, felt nl until 5PM when temp went up to 103.4;felt sl nauseated, weak & had a severe piercing h/a;took APAP, temp went to 102.6 but wouldn't lower;called ER, to cold shower, take APAP 12NOV95 9AM temp 100, felt much improved				Y					Y	11/11/1995	11/11/1995	0	NONE	PVT	PVT	Zantac	NONE	no allergies, gastric ulcer	NONE~ ()~~~In patient		1						1	Asthenia; Headache; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61117~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0080136	12/19/1995	SC	52.0	52		F	12/06/1995	acute Guillain-Barre Synd; hospitalized 5 days-recvd 5 rounds of immune globulin			Y		Y	5		Y		10/27/1995	11/04/1995	8	protein inc in CSF	PUB	UNK	Prinivil, Lopid, Glucotrol xl, Synthyroid			~ ()~~~In patient		1						1	CSF test abnormal; Guillain-Barre syndrome	FLU3~PFIZER\WYETH~4958079~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0080142	12/19/1995	MI	37.0	37		M	10/25/1995	devel Bells Palsy 19OCT95				Y					Y	10/03/1995	10/19/1995	16		PUB	OTH	Proventil, Beclovent, Albuterol sulfate inhalation, uni-Dur	denies	asthmatic	~ ()~~~In patient		1						1	Facial palsy	FLU3~PFIZER\WYETH~4450111~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0080144	12/19/1995	PA	36.0	36		F	12/11/1995	chills-shaking, fever, nauseous-dry heaves, faint, hot head toe, warm feeling in chest				Y					Y	11/29/1995	11/29/1995	0		OTH	PUB		NONE	NONE	NONE~ ()~~~In patient		1						1	Chills; Nausea; Pyrexia; Syncope; Tremor; Vasodilatation; Vomiting	FLU3~CONNAUGHT LABORATORIES~5F61024~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0080148	12/19/1995	OK	54.0	54		F	12/01/1995	w/in 2 hrs arm very sore when removed the bandaid, blister had erupted around the inj site;w/in 8 hrs other blisters on upper arm;pain in arm,shoulder, neck, upper spine;dx shingles				Y					N	11/07/1995	11/07/1995	0	herpes zoster dx antiviral prescribed	PVT	OTH	Atenolol for HTN	NONE-3mos p/mastectomy	vax in rt arm as lt arm affected by mastectomy	~ ()~~~In patient		1						1	Back pain; Herpes zoster; Injection site hypersensitivity; Myalgia; Neck pain; Pain; Rash maculo-papular	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0080156	12/19/1995	RI	41.0	40		M	12/12/1995	h/a, fever 103, chills, nausea about 4hrs p/vax;sxs persisted for up to 48hrs;treated w/APAP & DPH									U	12/05/1995	12/05/1995	0	NA	PUB	UNK	pt recvd Hep A vax		NONE	NA~ ()~~~In patient		1						1	Chills; Headache; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61100~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0080163	12/19/1995	ND	62.0	62		F	12/11/1995	pt stated rt arm was red around inj site & warm to touch approx 2 in diameter;called daughter-in-law who is lab tech & advised pt to take DPH & apply ice pack @ intervals which did give relief by the next day									Y	11/30/1995	11/30/1995	0	NA	PVT	UNK	Levothyroxine; HCTZ 50/25	NONE	hypothyroidism, HTN	~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PFIZER\WYETH~4958081~7+~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~394934~1~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0080166	12/19/1995	TX	23.0	23		M	11/27/1995	swelling arm 19x8cm lasted 10 days local rxn complete recovery-mild egg allergy;									Y	10/19/1995	10/20/1995	1	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site reaction; Oedema	FLU3~CONNAUGHT LABORATORIES~5F61093~5~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079870	12/20/1995	OH	58.0	58		F	12/13/1995	pt recvd vax;back pain,progressive numbness of hips & lower extremities;difficulty walking,urinary incontinence;sxs began 29oct95;supportive tx,gradual improvement;				Y	Y	8			N	10/26/1995	10/29/1995	3	MRI brain, spine nl; CSF protein inc;	UNK	UNK	none known	none	hypothyroid condition;	none~ ()~~0.00~In Patient		1						4	CSF test abnormal; Encephalitis; Hypokinesia; Myelitis; Paraesthesia; Paralysis; Urinary incontinence; Anorectal disorder; Back pain; Hypokinesia; Pain; Paraesthesia; Urinary incontinence; Back pain; CSF test abnormal; Hypokinesia; Paraesthesia; Urinary incontinence; Back pain; Encephalitis; Hypokinesia; Myelitis; Pain; Paraesthesia; Urinary incontinence	FLU3~CONNAUGHT LABORATORIES~5F61133~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~5F61133~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~5F61133~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~4|FLU3~CONNAUGHT LABORATORIES~5F61133~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~5	USA	Hospitalisation	Influenza
0080174	12/20/1995	IL	73.0	73		F	12/18/1995	pt recvd vax; devel pneumonia & was hosp on ventilator assistance;died 31oct95;no autopsy performed;COD pneumonia & resp arrest;	Y	10/31/1995			Y				N	10/11/1995	10/15/1995	4		PVT	PVT	numerous		5 yr hx of fibrotic lung disease,arteriosclrosis w/ renal angioplasy,carotid enarterectomy,stroke;living w/ husband as care giver;	pneumonia 1 wk p/ 1994 flu vax;~ ()~~~In patient	CO6416	1						1	Apnoea; Pneumonia	FLU3~CONNAUGHT LABORATORIES~5F61099~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0079870	12/21/1995	OH	58.0	58		F	12/11/1995	pt recvd vax; back pain, progressive numbness of hips & lower extremities; difficulty walking; urinary incontinence starting on 29oct95; er & hosp admission 31oct95; encephalomyelitis				Y	Y					10/26/1995	10/26/1995	0	MRI brain, spine nl 31oct95; CSF protein inc 31oct95;	UNK	UNK			possible hypothyroid condition	~ ()~~~In patient		1						5	CSF test abnormal; Encephalitis; Hypokinesia; Myelitis; Paraesthesia; Paralysis; Urinary incontinence; Anorectal disorder; Back pain; Hypokinesia; Pain; Paraesthesia; Urinary incontinence; Back pain; CSF test abnormal; Hypokinesia; Paraesthesia; Urinary incontinence; Back pain; Encephalitis; Hypokinesia; Myelitis; Pain; Paraesthesia; Urinary incontinence	FLU3~CONNAUGHT LABORATORIES~5F61133~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~5F61133~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~5F61133~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~4|FLU3~CONNAUGHT LABORATORIES~5F61133~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~5	USA	Hospitalisation	Influenza
0080188	12/21/1995	MN	68.0	68		M	12/06/1995	pt recvd vax; GBS;first numbness on 28nov95; hosp 29nov95; Plasmaphoresis; still in hosp as of 6dec95;					Y	7	Y		N	11/14/1995	11/28/1995	14	CAT scan, spinal tap@ 64	PUB	PUB	hypertension medication	none	paget's disease of the spine, hypertension;	~ ()~~~In patient	MN95031	1						1	Guillain-Barre syndrome; Paraesthesia; CSF test abnormal; Guillain-Barre syndrome; Hypoaesthesia; Hypokinesia; Paraesthesia	FLU3~PFIZER\WYETH~4958227~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4958227~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0080190	12/21/1995	MO	34.0	34		F	12/21/1995	pt recvd vax; exp abdo cramping,pain,nausea,vomiting p/ flu vax;hosp on 24dec93 & dx w/ acute GBS;exp full paralysis for 5 mo & then partial paralysis since may94;					Y			Y	Y	11/04/1993	11/04/1993	0	none reported;07Oct96-MFR f/u-nerve conduction tests showed a severe polyarthropathy,CSF exam - nl protein;	OTH	OTH	unk	none	none reported		ALI95519	1						1	Abdominal pain; Asthenia; Guillain-Barre syndrome; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~2243GC~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0080191	12/21/1995	NY	60.0	59		F	12/19/1995	pt recvd vax; adm to hosp w/ GBS for 5 mo; difficulty standing, walking,gripping etc...			Y	Y	Y	150	Y	Y	N	12/09/1994	01/18/1995	40	plasma pheresis; extensive testing, SCANS, EKG's & MRI	PVT	PVT	none	slight cold	none	~ ()~~~In patient		1						1	Amnesia; Depression; Gait disturbance; Guillain-Barre syndrome; Hypokinesia; Hypotonia; Myasthenic syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4F5115~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0080192	12/21/1995	CA	65.0	65		M		pt recvd vax; GBS starting w/ numbness & tingling fingers; progressed to inability to walk;					Y				N	10/04/1995	10/18/1995	14		PVT	PVT		none		~ ()~~~In patient		1						1	Guillain-Barre syndrome; Hypoaesthesia; Hypokinesia; Paraesthesia	FLU3~PFIZER\WYETH~4958117~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0080194	12/21/1995	CA	66.0	65		M		pt recvd vax; adm to hosp for orthopedic surgery; sxs of GBS 2 days p/ surgery					Y	7			Y	10/27/1995	11/23/1995	27		PVT	PVT		none	major surgery 2 days before sxs;	~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLU3~PFIZER\WYETH~9458116~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0080195	12/21/1995	WI	24.0	24		F	12/07/1995	pt recvd vax; aches, myalgias, malaise; myopathy dx 13nov95;hosp & hydrated Nov 3-7, no apparent perm sequelae, musc bx=nonspec myopathy w/o toxic postviral metabolic myopathies.					Y					10/30/1995	11/03/1995	4	CK 26590 3nov95, 7840 on 9nov95, 5280 on 16nov95 & 727 on 22nov95; ALT 103; TSH 0.72; freeT4 1.2; AST 465; Crest 0.8;	UNK	UNK	depo provera		myopathy, post viral metabolic myopathies	~ ()~~~In patient		1						1	Alanine aminotransferase increased; Aspartate aminotransferase increased; Blood creatine phosphokinase increased; Blood creatinine increased; Dehydration; Hypothyroidism; Myalgia; Myopathy	FLU3~CONNAUGHT LABORATORIES~5J61007~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0080199	12/21/1995	NY	56.0	56		M	11/13/1995	day of vax flu vax devel complete flu like sxs-lasting 2 days;									Y	11/13/1995	11/13/1995	0	NA	PUB	UNK	NONE	flu-like	NONE	~ ()~~~In patient	BA9648	1						1	Influenza	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0080203	12/21/1995	ND	76.0	75		F	12/07/1995	21NOV phone call to clinic stating pt had 4 x 5 rash, swelling, aching, itchy rt deltoid;pt instructed to take DPH & put cold pack, on MD notified;24NOV pt called by RN stated swelling better now instructed to wait 15mins p/flu vax									Y	11/20/1995	11/20/1995	0		PVT	PVT		NONE	Motrin-Naprosyn	~ ()~~~In patient		1						1	Myalgia; Oedema peripheral; Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~4958081~2~~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~394934~1~~RL~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0080207	12/21/1995	MN	69.0	69		F	10/26/1995	had immun in AM, about 1030AM;about 12noon or 1PM became dizzy, lightheaded, warm;has chills & sweats;lt arm became very sore;sxs cont to present;14NOV95 fatigue lasted 3-4 days;soreness @ site lasted 10 days									Y	10/23/1995	10/23/1995	0	NONE	PUB	PUB	VOltaren, Tenormin, Premarin	NONE	arthritis, hypertension, PAT	pt exp rxn w/flu vax~ ()~~~In patient	MN95026	1						1	Asthenia; Chills; Dizziness; Hyperhidrosis; Injection site pain; Myalgia; Vasodilatation	FLU3~PFIZER\WYETH~4958140~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1541A~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0080208	12/21/1995	TN	44.0	44		F	12/08/1995	pt recvd vax 8DEC95 about 10mins p/vax pt devel a rxn @ the site of inj-red raised area about the size of a quarter;states arm felt like it would pop open & had a h/a;called MD told take DPH & observe x 1hr;c/o h/a, flushed, diff breathing									Y	12/08/1995	12/08/1995	0		PUB	PUB		NONE	allergic to PNC, hypertension	pt recvd vax 9NOV95 was nauseated & felt bad x 3 days w/HBV vax~ ()~~~In patient	TN95130	1						1	Dyspnoea; Headache; Hypokinesia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61126~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SMITHKLINE BEECHAM~1746A4~2~IM~LA~HEP B (ENGERIX-B)~1	USA		Influenza
0080210	12/21/1995	MN	59.0	59		F	10/30/1995	verbalized a stinging sensation felt immed p/inj into rt deltoid;by evening noted golf ball sized swelling @ inj site along w/pink blotches & cont stinging sensation;As of 27OCT swelling absent, blotches & stinging faded completely by 30OC									Y	10/25/1995	10/25/1995	0		PUB	PUB	NONE	NONE	allergic to tetracycline	~ ()~~~In patient	MN95032	1						1	Injection site mass; Injection site oedema; Injection site pain; Rash	FLU3~PFIZER\WYETH~4958240~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1076B~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0080211	12/21/1995	VA	46.0	46		F	12/15/1995	no problems @ time of inj;24-48 hrs later pt exp pain in elbow;had trouble gripping & twisting lid off jars;pain went up into shoulder & neck;seeing a RPT for treatments;dx w/tendonitis;denies any pain, numbness, redness or swelling @ inj										11/02/1995	11/04/1995	2	pt states no lab work done	OTH	PUB	NONE	states rt arm under stress		~ ()~~~In patient		1						1	Hypotonia; Myasthenic syndrome; Pain; Tendon disorder	FLU3~PFIZER\WYETH~4958115~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~SMITHKLINE BEECHAM~1725A4~UNK~IM~LA~HEP B (ENGERIX-B)~1	USA		Influenza
0080212	12/21/1995		29.0			F		pt recvd vax 315PM sl facial & chest pruritis noted 350PM; MD notified pt brought to clinic given epi & DPH;pt now sl SOB-clearing throat;										11/17/1995	11/17/1995	0		UNK	UNK	BCP		NONE	~ ()~~~In patient		1						1	Dyspnoea; Pruritus; Salivary hypersecretion	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0080213	12/21/1995	IL	32.0	32		F	12/13/1995	rt edema of arms w/erythema, mild swelling pharynx									Y	11/12/1995	12/13/1995	31	NONE	PVT	PVT			bilat contrast, PCN	NOND~ ()~~~In patient		1						1	Laryngospasm; Oedema peripheral; Rash	FLU3~PARKE-DAVIS~01595P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0080767	12/21/1995	MN	65.0	65		F	11/16/1995	pt recvd vax; red swollen areas down lt arm, states appears to be fluid filled;f/u 29nov95 swelling resolved after 1 wk; no problems since;did not require hosp or med;				Y					Y	11/14/1995	11/15/1995	1		PUB	PUB				na~ ()~~~In patient	MN95030	1						1	Dermatitis bullous; Oedema; Vasodilatation	FLU3~PFIZER\WYETH~4958227~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1559A~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0080188	12/22/1995	MN	68.0	68		M	11/30/1995	pt recvd vax;28nov95 devel numbness & tingling in lower extremities;became unable to walk & was adm to hosp on 29nov95;dx of GBS made;				Y	Y				U	11/14/1995	11/28/1995	14		PUB	PUB	tenormin tablets	none		na~ ()~~~In patient	895335001L	1						2	Guillain-Barre syndrome; Paraesthesia; CSF test abnormal; Guillain-Barre syndrome; Hypoaesthesia; Hypokinesia; Paraesthesia	FLU3~PFIZER\WYETH~4958227~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4958227~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0080218	12/22/1995	CA	67.0	67		M	12/05/1995	pt recvd vax; was adm to hosp 24nov95 w/ dx of GBS;					Y				U	11/03/1995	11/24/1995	21		PVT	PVT	unk	unk		~ ()~~~In patient	895341003L	1						1	Asthma; CSF test abnormal; Dry eye; Facial palsy; Gait disturbance; Guillain-Barre syndrome; Pain; Paraesthesia	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0080219	12/22/1995	NC	40.0	39		F	12/06/1995	pt recvd vax;was adm to hosp w/ dx of a mild case of GBS;pt hosp for 5 days & was discharged w/ urinary catheter;					Y	5			U	11/03/1995	11/20/1995	17		PVT	PVT	zoloft		pt had flu immun in the past yr;	~ ()~~~In patient	895347005L	1						1	Dysuria; Guillain-Barre syndrome; Influenza; Leukocytosis; Myalgia; Urinary tract infection	FLU3~PFIZER\WYETH~4958079~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0080233	12/26/1995	NY	52.0	51		F	12/26/1995	pt recvd vax; had immed crushing pain in rt hand;w/in 15 min began to feel really weird, felt woozy, strange odd;T 100-101, hives on face & neck; LOC fro 16 hrs;woke w/ fever, congestion; felt like the flu; still feels weird;			Y	Y					N	11/16/1995	11/16/1995	0	none	PVT	OTH	apap; ear drops; topical ointment		hx of neck/head injury;visually handicapped;lupus, mult chemical allergies, bronchitis	~ ()~~~In patient		1						1	Dizziness; Influenza; Malaise; Pain; Pharyngitis; Pyrexia; Stupor; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0080235	12/26/1995	TX	55.0	55		F	12/11/1995	3 days p/vax felt achy, began exp pain in joints;states pain extreme in knees by 12DEC95, sought medical treatment;pain also beginning in spine & neck getting stiff, Darvocet q 4-6 hrs rx, bed rest x 4 days				Y					N	11/27/1995	11/30/1995	3	NONE	PUB	PUB	Vasoretic for HTN	NONE	h/o rheumatic fever @ 10yrs of age, HTN controlled	~ ()~~~In patient	TX95248	1						1	Arthralgia; Hypertonia; Myalgia; Nuchal rigidity	FLU3~PFIZER\WYETH~4958088~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0080238	12/26/1995	SC	76.0	76		M	12/18/1995	awakened 1NOV95 w/ 2 big toes & rt wrist in grid-lock w/the gout-lasted 5 days; no relationship to flu vax was MD opinion				Y					Y	10/31/1995	11/01/1995	1		UNK	UNK				~ ()~~~In patient	SC95085	1						1	Gout; Hypertonia	FLU3~PFIZER\WYETH~4958133~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0080245	12/26/1995	KY	57.0	57		F	12/13/1995	first was lightheadedness;then a burning or raw & tingling under arm down to elbow 7 all across chest & breast, w/a feeling of having an resp problem & still having the same problem;									Y	10/25/1995	10/25/1995	0		MIL	UNK	Maxide;Tagament	NA		~ ()~~~In patient		1						1	Chest pain; Dizziness; Dyspnoea; Myasthenic syndrome; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~5F61014~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0080345	12/27/1995	WA	59.0	59		F	12/12/1995	pt left WA state on 23OCT95 11 days p/vax to travel by car-1st sxs dry throat, lips tingling, tongue felt thick;3NOV h/a, legs shaky, legs gave out-hosp 20NOV-27NOV ascending paralysis;					Y			Y	N	10/12/1995	10/23/1995	11		PUB	PVT	NONE		unk	~ ()~~~In patient	WA951192	1						1	Dry mouth; Guillain-Barre syndrome; Headache; Hypokinesia; Myasthenic syndrome; Paraesthesia; Paralysis; Tongue oedema	FLU3~PFIZER\WYETH~4958112~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0080362	12/27/1995	MI	48.0	48		M	12/18/1995	4 days following vax devel malaise @ work;chills&fever followed&left work & went to bed;following day, rhinitis & repetitive sneezing ensued;2nd day asthma like difficulties & sinusitis developed;progressed to brochials 3rd & 4th days				Y					Y	11/29/1995	12/04/1995	5		PUB	UNK		NONE	NONE	~ ()~~~In patient	MI95156	1						1	Asthma; Bronchitis; Chills; Malaise; Pyrexia; Rhinitis; Sinusitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0080373	12/27/1995	VA				U		sleepiness, malaise, pallor, bruising @ the site, loss of endurance, dec energy, anorexia onset w/in 12 hrs of vax lasting 2 wks;treated w/Pred- inc appetite, energy dec still pale									Y	11/30/1995	12/01/1995	1		MIL	MIL	Theophylline, albutenol, inhaled triaminolone	NONE	severe asthma	~ ()~~~In patient		1						1	Anorexia; Asthenia; Ecchymosis; Malaise; Pallor; Somnolence	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0080063	12/28/1995	CO	61.0			M	12/10/1995	pt c/o lower extremity weakness w/diff walking;bilat tingling in upper arms through the hands;hx lumbosacral pain;woke up w/inc weakness,diff standing;exp rhinorrhea w/URI sxs;dec strength;dx GBS vs poss spinal cord lesion vs botulism tox					Y				U	11/08/1995	11/20/1995	12	chloride 112, WBC count 11.1, hematocrit 25.9, MCV 59, platelet count 687; calcium was 9.6, alakaline phos 161, AST 28, amylase 47, total bilirubin 0.5;CXR showed rt lower lobe nodule/mass;	PVT	PVT	NONE			~ ()~~~In patient		1						2	Anaemia; Guillain-Barre syndrome; Hypotonia; Infection; Lung disorder; Gastrointestinal haemorrhage; Guillain-Barre syndrome; Lung disorder; Microcytic anaemia; Myasthenic syndrome; Neoplasm malignant; Paraesthesia; Paralysis	FLU3~PFIZER\WYETH~4958116~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4958116~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0080385	12/28/1995	WV	76.0	76		M	12/19/1995	1-2 days p/vax had minor redness & soreness-1mo later, wife calls to report ongoing soreness & ?numbness when seen in office only complaint was soreness @ inj site-no redness, irritation, etc noted									Y	11/13/1995	12/17/1995	34		PUB	UNK	NONE	NONE	NONE	~ ()~~~In patient	WV9520	1						1	Injection site pain; Myalgia; Paraesthesia; Rash	FLU3~CONNAUGHT LABORATORIES~5F61024~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0080570	12/29/1995	PA	18.0	18		F	12/19/1995	erythema, induration, swelling rt arm around inj site started 24hrs increasing over 72hrs;fever to 103; treated w/ATB-Keflex;referred to surgeon to r/o abscess;				Y					Y	11/09/1995	11/10/1995	1	WBC 15.5, 84% segs, no bands 12NOV95 a/ATB	PVT	PVT	Vanceril inhaler, proventil inhaler PRN	asthma-stable	asthma, perencal rhinitis, NKDA, probably atopic	~ ()~~~In patient		1						1	Abscess; Injection site hypersensitivity; Injection site mass; Injection site oedema; Leukocytosis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61115~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~394934~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0080572	12/29/1995	NC	75.0	74		M	12/10/1995	productive cough;h/a 2 days, runny nose									N	11/17/1995	11/18/1995	1	NONE	PUB	PUB	NONE	did not feel well	NONE	~ ()~~~In patient	NC95127	1						1	Cough; Headache; Rhinitis	FLU3~PFIZER\WYETH~4958125~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079870	01/02/1996	OH	58.0	58		F	12/11/1995	back pain, progressive numbness of hips and lower extremities;diff walking, urinary incontinence;sxs began 27OCT95;ER & advisor 31OCT95; supportive tx				Y	Y	8			N	10/28/1995	10/29/1995	1	MRI brain, spine nl; CSF protein inc;	OTH	PVT	NONE	NONE	hypothyroid condition	~ ()~~~In patient		1						3	Back pain; CSF test abnormal; Dysuria; Hypokinesia; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~5F61133~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Hospitalisation	Influenza
0080576	01/02/1996	PA	51.0	51		F	10/27/1995	pain in lt arm, neck, upper back, h/a, sore eyes;has caused loss of sleep; takes ASA for h/a;									Y	10/16/1995	10/17/1995	1		OTH	PUB		NONE	NONE	~ ()~~~In patient	PA95217	1						1	Back pain; Eye pain; Headache; Insomnia; Neck pain; Pain	FLU3~PFIZER\WYETH~~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0080580	01/02/1996	ME	53.0	53		F	12/20/1995	cold sxs 1wk p/shot followed by joint pain 2-2 1/2 wks p/shot; joint pain started in lt foot has progressed to both feet, knees, wrists, hands & elbows;dx rheumatoid arthritis				Y						10/01/1995	11/04/1995	34	CBC, SMA 18, sed rate, ritchie IV	PVT	PVT	Paxil, provera, premerin, Lodine	NONE	depression	~ ()~~~In patient	ME95028	1						1	Arthralgia; Pain; Pharyngitis; Rheumatoid arthritis; Rhinitis	FLU3~PFIZER\WYETH~4958116~6~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0080582	01/02/1996	NC	40.0	40		F	11/27/1995	rash all over 2wks p/shot;rash itched;MD felt this was related to flu shot				Y					Y	10/26/1995	11/09/1995	14	NONE	PUB	PVT	unable to get info	NONE	unable to get info from pt	unable to get info~ ()~~~In patient	NC95129	1						1	Pruritus; Rash; Injection site hypersensitivity; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~5F61023~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~5F61023~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0080582	01/02/1996	NC	9.0	9		M	11/27/1995	pt pt recvd vax & 2wks later had a quarter size area where inj was given w/small bumps w/in;bumps spread across shoulder to mid back;MD felt this was related to flu vax;									Y	10/26/1995	11/09/1995	14	NONE	PUB	PVT	unk	NONE	asthma	unk~ ()~~~In patient	NC95131	1						2	Pruritus; Rash; Injection site hypersensitivity; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~5F61023~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~5F61023~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0080586	01/02/1996	PA	32.0	32		M	11/20/1995	pt recvd vax & verbalized nauseated, weak, felt urge to defecate, diaphoretic;radial pulse 48 & erratic;BP not audible or palpable;paramedics called;color ashen;episode cont for approx 20-30mins;BP 108/60;				Y					Y	11/20/1995	11/20/1995	0	NONE	PUB	PUB	Doxycycline	NONE	recovering from sinusitis;asymptomatic	In 1991 pt was same rxn to Decadron Im~ ()~~~In patient	PA95226	1						1	Arrhythmia; Asthenia; Bradycardia; Cyanosis; Hyperhidrosis; Hypotension; Nausea	FLU3~PARKE-DAVIS~01185P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0080587	01/02/1996	MA	44.0	44		M		body aches, fever, diarrhea x 4 days									Y	10/13/1995	10/14/1995	1		OTH	UNK				~ ()~~~In patient		1						1	Diarrhoea; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61134~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0080588	01/02/1996	MA				F		body aches, 1 hr post inj lasting 1-2hrs;									Y	10/13/1995	10/13/1995	0		OTH	UNK				~ ()~~~In patient		1						1	Myalgia	FLU3~CONNAUGHT LABORATORIES~5F01134~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0080589	01/02/1996	MA	87.0	87		F		laryngitis of unk origin;pt has hx of CA larynx;no obvious recurrence;? flu rxn;									N	10/16/1995	10/18/1995	2		UNK	UNK			hx CA largnx	~ ()~~~In patient		1						1	Laryngitis	FLU3~CONNAUGHT LABORATORIES~5F61134~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0080591	01/02/1996	PA	45.0	45		M	12/06/1995	the next AM p/getting 1st flu shot ever pt's lt arm very sore, red, hot, swollen @ inj site;saw MD 4DEC & was put on Keflex				Y					Y	12/01/1995	12/02/1995	1	NONE	PUB	PUB	Acupril, Varapamil; BP meds	NONE	high blood pressure	NONE~ ()~~~In patient	PA95224	1						1	Injection site oedema; Myalgia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61024~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0080683	01/03/1996	NY	60.0			F	12/03/1995	nausea, vomiting, h/a;			Y						Y	11/27/1995	11/28/1995	1	NONE	OTH	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Headache; Nausea; Vomiting; Headache; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~5F61014~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening	Influenza
0080686	01/03/1996	CT	26.0	26		F	12/21/1995	pt recvd vax 1DEC95 & exp muscle weakness & paresthesia on 3DEC; adm to hosp 6DEC w/extensive w/u for large muscle group weakness & paresthesias-poss meningoencephalitis					Y	3			Y	12/01/1995	12/03/1995	2	CT, MRI of brain & cord, LP, extensive serologic w/u all neg	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Encephalitis; Myasthenic syndrome; Paraesthesia	FLU3~PFIZER\WYETH~4958091~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0080688	01/03/1996	AL	14.0	14		M	12/24/1995	22DEC95 fever x 12k; 28DEC95 sz 9PM-fever encephalopathy					Y				U	12/15/1995	12/22/1995	7	CT neg, LP neg	PUB	PUB		NONE	NONE		AL9539	1						1	Convulsion; Encephalopathy; Pyrexia	CHOL~PFIZER\WYETH~4958031~1~SC~LA~CHOLERA (USP)~1|FLU3~PFIZER\WYETH~4958114~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEPA~SMITHKLINE BEECHAM~165A2~1~IM~LA~HEP A (HAVRIX)~1|TYP~CONNAUGHT LABORATORIES~K1160~1~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Hospitalisation	Influenza
0080693	01/03/1996		26.0			M	12/18/1995	emesis x 1 10 mins p/vax start of h/a mins later;h/a described as rt sided sinus h/a not sharp or dull, constant w/some throbbing; neg assoc photophobia;started to resolve p/30 mins				Y					Y	11/04/1995	11/04/1995	0	finished pulse dose pred 1 day prior for lichen planus	MIL	MIL			lichen planus-pulse dose pred			1						1	Headache; Vomiting	FLU3~CONNAUGHT LABORATORIES~5J61010~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~SMITHKLINE BEECHAM~VHA436A6~1~IM~~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0080700	01/03/1996	NJ	29.0	29		M	12/28/1995	immed redness & swelling @ site; tx w/DPH & cool compresses									Y	12/28/1995	12/28/1995	0	NONE	PVT	PVT	NONE	bronchitis	? PCN allergy; hx cholesteatrine lt ear	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4958109~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4958109~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0080701	01/03/1996	AZ	72.0	72		M	12/26/1995	pt recvd vax & exp flu-like sxs severe w/T102 worsened; 2 MD's dx PMR (polymyalgia rheumatica)				Y					N	11/03/1995	11/15/1995	12	sed rate 85/HR-muscle enzymes OK; CFK, Aldolase	PVT	PVT	NONE	NONE	glaucoma	NONE~ ()~~~In patient		1						1	Influenza; Myalgia; Pyrexia; Red blood cell sedimentation rate increased	FLU3~CONNAUGHT LABORATORIES~~1~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0079479	01/04/1996	MI	69.0	69		F		nausea, vomiting, sweating, eyes draining;										11/10/1995	11/10/1995	0	NONE	UNK	UNK	NONE		NONE	~ ()~~~In patient		1						2	Conjunctivitis; Hyperhidrosis; Nausea; Vomiting	FLU3~PARKE-DAVIS~00295P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~PFIZER\WYETH~390967~UNK~IM~~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0080704	01/04/1996	OH	51.0	51		F	11/30/1995	frozen shoulder sick in bed w/flu;muscle relaxant & osteopathy,ultrasound 12NOV94,14NOV94,15NOV94 ER severe pain in shoulder,diaphoresis,shaking (like a leaf on a tree in the wind);adm ER to ICU;t101.4;staph aureus septicemia;emphysema			Y	Y	Y	21	Y	Y	N	11/01/1994	11/12/1994	11	PPD neg; mumps 5mm (24hrs neg 48 hrs; candida neg; Trichapuyton neg	OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Arthralgia; Emphysema; Hypokinesia; Infection; Influenza; Mental retardation severity unspecified; Thinking abnormal; Tremor	FLU3~PARKE-DAVIS~~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0080709	01/04/1996	OH	35.0	35		F	12/01/1995	ringing in ears (for 1 mon); lt sided body numbness (for 1mo); had MRI to have spinal tap & blood work;									Y	10/14/1995	10/28/1995	14	MRI abn	OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Laboratory test abnormal; Paraesthesia; Tinnitus	FLU3~PARKE-DAVIS~00575P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0080711	01/04/1996	FL	35.0	35		M	12/29/1995	1hr p/vax severe violent vomiting-stomach pain-diarrhea-for approx 3 hrs;										12/28/1995	12/28/1995	0		UNK	UNK				~ ()~~~In patient		1						1	Abdominal pain; Diarrhoea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0080715	01/04/1996	NC	47.0			F		2 1/2 x 1 1/2 area of redness & elevated skin temp lt deltoid area; redness-swelling; dx local rxn to vax;										11/08/1995	11/10/1995	2		UNK	UNK			alllergic rxn to bee sting OCT94	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61167~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0080717	01/04/1996	NC	46.0			F		4x5cm diameter erythemic, warm to touch area; lt upper arm pinpoint center noted to be slightly harder than the outer area;										11/08/1995	11/08/1995	0	sent for eval by personal physician	UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61167~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0080721	01/04/1996	WA	35.0	35		M	12/05/1995	pt had dime sized area of inflammation immed p/vax; had hx of flu shot 1yr ago w/o problems;pt c/o SOB;vital signs remained stable;pt was briefly examined by MD;									Y	12/01/1995	12/01/1995	0	NONE	PUB	UNK	ATB	NONE	NONE	NONE~ ()~~~In patient	WA951193	1						1	Dyspnoea; Injection site hypersensitivity	FLU3~PFIZER\WYETH~4958120~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0080766	01/05/1996	PA				U		pt recvd vax; supposed death;	Y													UNK	UNK				~ ()~~~In patient		1						1	Unevaluable event	FLU3~MEDEVA PHARMA, LTD.~E2715HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0080773	01/05/1996	MD	62.0	62		M	11/28/1995	pt recvd vax;body aches, chills;cough productive of dark brown mucous, SOB 9oct95; seen by MD;ATB for 10 days; returned to work 23oct95;c/o some SOB; felt fully recovered 30oct95;dx w/ pneumonia;				Y					Y	10/04/1995	10/05/1995	1	CXR 9oct95 & CT scan of lungs on 16oct95;bloodwork & sputum x 1 all nl;	PUB	PUB	coumadin qd	chills, dry cough, aches 2 wks prior	atrial fib;ablation of av node oct94;recently completed 6 mo INH prophy;	chills, fever at 25 yrs p/ 1st flu shot;~ ()~~~In patient	MD95050	1						1	Chills; Cough; Dyspnoea; Myalgia; Pneumonia	FLU3~CONNAUGHT LABORATORIES~5F61120~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0080775	01/05/1996	WV	53.0	53		M	11/06/1995	pt recvd vax;soreness in joint muscles  & soreness at inject site;30oct95 rash raised devel around inject site;skin very tender to touch & extended to arms pits;feels T slightly inc and chills & weakness;									Y	10/24/1995	10/27/1995	3		PUB	PUB	xanax		gastroenteritis	~ ()~~~In patient	MD95045	1						1	Arthralgia; Asthenia; Chills; Injection site hypersensitivity; Injection site pain; Myalgia; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5761127~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0080776	01/05/1996	DE	42.0	42		F		pt recvd vax; throat swelling; eyes red, burning, sandpapery & draining thick yellow exudate;anuria/failure;agitation,resp,HA, SOB;myalgia,N & chills & diaphoretic;									Y	11/01/1995	11/01/1995	0	na	PUB	PUB	synthroid, claritin, ogen,colace, calcium	none	none	none~ ()~~~In patient	MD95046	1						1	Agitation; Anuria; Chills; Conjunctivitis; Dyspnoea; Headache; Laryngospasm; Myalgia	FLU3~CONNAUGHT LABORATORIES~5F61120~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0080779	01/10/1996	TX	71.0	71		F	10/28/1994	pt recvd vax; 22oct94 awoke w/ lt arm swollen & tender, feverish;23oct94 tongue began swelling, neck & throat as well; to er; dph given, decadron,put on oral pred;				Y					Y	10/21/1994	10/22/1994	1		PUB	PUB	procardia	none		~ ()~~~In patient	TX96005	1						1	Injection site oedema; Injection site pain; Laryngospasm; Pyrexia; Tongue oedema	FLU3~PFIZER\WYETH~4948131~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0080782	01/11/1996	WA	55.0	55		M	12/12/1995	pt recvd vax;30 days later,foot pain,trouble walking;weakness progressed;by day 50 unable to walk;unable to crawl,dress,roll over in bed;EMG consistent w/ GBS or severe non neuropathy multiplex;								Y	N	10/09/1995	11/20/1995	42	CSF:0cells, prot=225;CMV pcr neg;EMG consistent w/GBS or severe multifocal mononeuropathy multiplex w/ underlying peripheral sensorimotor poly neuropathy	UNK	UNK			hiv positive in 1987 w/ burkitt's symphoma;tx w/ xrt & no occurence since;a symptomatic inc amylase due to alcohol;	~ ()~~~In patient		1						1	CSF test abnormal; Guillain-Barre syndrome; Hypokinesia; Myasthenic syndrome; Neuropathy; Pain	FLU3~PFIZER\WYETH~4958112~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0080785	01/11/1996	TX	11.0	11		M	01/08/1996	pt recvd vax; 5 min p/ vax, became nauseated; felt bad all over;3 hrs later high T; flu sxs, body aches; T 105.1 in er;				Y					Y	12/09/1995	12/09/1995	0	none	PVT	OTH	asma court, ritalin;	none	hyperactivity, asthma	na~ ()~~~In patient		1						1	Influenza; Malaise; Myalgia; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0080788	01/11/1996	CA	67.0			F		pt recvd vax; exp n; no vomiting; felt this way on way home p/ shot;nothing taste good;intermittent HA;for 2 wks had rectal hives(but has had this for 40 yrs)										10/18/1995	10/18/1995	0	none	UNK	UNK	paxil for depression, rosecea;		depression, intolerance to eggs, rectal hives.	~ ()~~~In patient		1						1	Condition aggravated; Dysgeusia; Headache; Nausea; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0080791	01/11/1996	GA	56.0	56		F		pt recvd vax & broke out in a rash on arms/legs;joints fingers, wrists, elbows, knees, hips, and feet sore;rash did not itch; no induration;feet and knees remain sore				Y					N	10/19/1995	10/28/1995	9		PVT	PVT	estrogen, provera	none	none	none~ ()~~~In patient		1						1	Arthralgia; Myalgia; Rash; Arthralgia; Oedema peripheral; Pain; Rash	FLU3~PFIZER\WYETH~4958136~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0080793	01/11/1996	NY	45.0			F	12/07/1995	pt recvd vax; devel severe irritation at site of inject;swelling & hot to touch;rash on neck, face & back;											11/06/1995			UNK	UNK				~ ()~~~In patient		1						1	Injection site oedema; Rash; Vasodilatation	FLU3~PFIZER\WYETH~495101~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0080795	01/11/1996	CO	24.0	24		F	12/28/1995	pt recvd vax;devel rash on lt arm;pt had rxn to contact lens solution therefore for MD thought it may be a reaction to preservative;pt discharged w/ order of dph;				Y						10/19/1995	10/19/1995	0		UNK	UNK				~ ()~~~In patient		1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0080797	01/11/1996	MT				U	12/12/1995	pt recvd vax; pain at inject site which exceeded 4 wks;											10/23/1995		none	UNK	UNK			none	~ ()~~~In patient		1						1	Injection site pain	FLU3~PFIZER\WYETH~4958112~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0080798	01/11/1996	MD	78.0			M	11/21/1995	pt recvd vax;23oct noticed jaundice & dark vine;adm to hosp on 7nov95 w/ progressive jaundice;bilirubin:26.5;liver biopsy shaved periductal inflammation w/ neutrophils;progressive liver failure; tx w/ iv steroids;										10/20/1995	10/23/1995	3	7nov95 bilirubin = 26.5; 20nov95 bilirubin = 46.5; ERCP nl; biopsy liver:periductal inflammation w/ neutrophils;	UNK	UNK	allopurinol, HCTZ, isosorbide, propranolol, ibuprofen		hx cell carcinoma; hx basal cell carcinoma;	~ ()~~~In patient		1						1	Hepatic failure; Hepatocellular damage; Hyperbilirubinaemia; Jaundice; Urine analysis abnormal	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0080809	01/11/1996	OK	67.0	67		M	12/28/1995	26OCT95 had chest pain, SOB & numbness in lt arm;had rash that PMD dx as bacterial infection;hospitalized x 2 days no dx by MD given;pvt MD feels illness not r/t flu vax				Y	Y	2			Y	10/25/1995	10/26/1995	1	EKG stress test x2 neg	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	OK961	1						1	Chest pain; Dyspnoea; Infection; Paraesthesia; Rash	FLU3~CONNAUGHT LABORATORIES~5F61120~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0080812	01/11/1996	AK	55.0	55		F		pt recvd vax 25OCT94 1130AM & 1PM pt c/o itching on neck & head then devel gen itching & rash that noc; seen morning 26OCT pt reports swelling of lips & tightness of throat;felt tongue swollen & fingers were swollen went to MD			Y						Y	10/25/1995	10/25/1995	0	NONE	PUB	UNK	Premarin, silver centrum	NONE	NONE/allergic to tomatoes	NONE~ ()~~~In patient	AK95038	1						1	Face oedema; Laryngospasm; Oedema peripheral; Pruritus; Rash; Tongue oedema	FLU3~PFIZER\WYETH~4958139~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening	Influenza
0080815	01/11/1996	MI	32.0	32		F	01/02/1996	hives, swelling in hands, feet, eyes, lips-voice was affected;went to ER was given Epi & DPH;currently on DPH & Pred				Y					Y	12/28/1995	12/28/1995	0		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MI96002	1						1	Dysphonia; Face oedema; Oedema peripheral; Urticaria	FLU3~PFIZER\WYETH~4958230~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0080822	01/11/1996	OR	41.0	41		F	11/07/1995	a short time p/vax became weak & was assisted to the floor;dec BP, dec LOC, 02 given, epi administered; EMT called & pt transported to ER				Y					Y	11/02/1995	11/02/1995	0		PUB	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Asthenia; Bronchitis; Hypersensitivity; Hypotension; Stupor	FLU3~PFIZER\WYETH~4958120~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0080824	01/11/1996	AK	79.0	79		F	11/13/1995	rt arm (Td) deep aching pain traveled down to rt calf;unable to move arm & difficult to walk;sxs started 24hrs p/vax; sxs resolving as of 16NOV95				Y					Y	11/08/1995	11/09/1995	1	NONE	PUB	PUB		NONE		~ ()~~~In patient	AK95042	1						1	Gait disturbance; Hypokinesia; Injection site pain; Myalgia	FLU3~PFIZER\WYETH~4958139~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~4J61014~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0080827	01/11/1996	CO	68.0	68		M	11/30/1995	pt recvd flu vax 20NOV95 & 23NOV95 devel intense burning & itching of the ulnar surfaces of back hands lasting 4 days;denies use of chemicals, etc;									Y	11/20/1995	11/23/1995	3	NA	PUB	PUB	Vitamins B & C	NONE	NONE	~ ()~~~In patient	CO95066	1						1	Pain; Pruritus	FLU3~PFIZER\WYETH~4958140~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0080829	01/11/1996	CO	68.0	68		M	12/18/1995	day p/shot pt reported general sense of malaise, swollen arm @ inj site w/multiple pin head sized dark red purple bumps (rash)-some bleeding @ site & red raised welts radiating from site in 3-4in diameter-resolved x 1wk									Y	12/05/1995	12/06/1995	1	NA	PUB	PUB	NA	NONE	severe rxn to typhus shot 30yrs ago	pt exp severe rxn to typhus shot 30yrs ago~ ()~~~In patient	CO95068	1						1	Haemorrhage; Injection site hypersensitivity; Injection site oedema; Malaise; Rash; Urticaria	FLU3~PFIZER\WYETH~4958120~4~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0080832	01/11/1996	AK	60.0	60		F	11/01/1995	pt recvd vax 31OCT95 PM had localized rxn severe, by 1NOV95 AM; deltoid & inner aspect of upper arm red, hot, edematous 5x7 inches										10/31/1995	11/01/1995	1		PUB	PUB	Premarin	NONE	Codeine	pt exp rxn in 1945 @ 10yrs old w/DTP unk dose~ ()~~~In patient	AK95039	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4958139~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0145A~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0080833	01/11/1996	AK	91.0	90		F	11/01/1995	pt reports rt arm was swollen red & painful from inj site to elbow;seen by ANP 12OCT95;										10/11/1995	10/11/1995	0		PUB	PUB	ASA;Lasic;potassium		allergic to sulfa	~ ()~~~In patient	AK95037	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia; Oedema peripheral	FLU3~PFIZER\WYETH~4958139~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0145A~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0080834	01/11/1996	AK	79.0	79		F	11/01/1995	pt reported large red swollen lump on rt arm below inj site-baseball size seen by ANP 12OCT;advised to use ice & APAP				Y					Y	10/11/1995	10/11/1995	0		PUB	PUB	heart meds; BP & ulcer meds	NONE		~ ()~~~In patient	AK95036	1						1	Oedema peripheral; Skin nodule; Vasodilatation	FLU3~PFIZER\WYETH~4958139~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0145A~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0080836	01/11/1996	AK	6.0	6		F	11/27/1995	vomiting several (3-4) times per day in the AM w/diarrhea every other day, starting the day p/shot & cont thru 21NOV;afeb throughout; tolerated liquids throughout									Y	11/14/1995	11/15/1995	1	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	AK95043	1						1	Diarrhoea; Vomiting	FLU3~PFIZER\WYETH~4958139~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0080362	01/16/1996	MI	48.0	48		M	12/18/1995	4days following vax pt devel malaise @ work;chills & fever followed & pt left work & went to bed;following day rhinitis & repetitive sneezing ensued;late 2nd day,asthma like difficulties & sinusitis developed;progressed to bronchials				Y					Y	11/29/1995	12/04/1995	5		PUB	UNK		NONE	NONE	~ ()~~~In patient	MI95156	1						2	Asthma; Bronchitis; Chills; Malaise; Pyrexia; Rhinitis; Sinusitis	FLU3~PFIZER\WYETH~4958230~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0080847	01/16/1996	KS	85.0	85		M	11/01/1995	pt recvd vax;T 100; wheezing 3nov95; emesis; apap given; to er;	Y	11/10/1995							N	11/01/1995	11/01/1995	0		UNK	UNK		none	pcn, demedrol, codeine,tape, beesting	~ ()~~~In patient	KS95057	1						1	Asthma; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~5F61162~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0080849	01/16/1996	CO	74.0	73		F	01/14/1996	pt recvd vax; to MD ofc for aches & pains;pain med prescribed;pt to hosp & was told that she had mononeuritis multiplex; sent to oth hosp for therapy; presently under MD 's care			Y		Y	17				10/10/1995	10/21/1995	11	MRI's - leg nerve biopsy, x rays	PVT	PVT		none	none	~ ()~~~In patient		1						1	Anorexia; Arrhythmia; Asthenia; Hypokinesia; Hypoventilation; Neuritis; Paraesthesia; Somnolence	FLU3~PFIZER\WYETH~4958116~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0080854	01/16/1996	MD	48.0	47		F	01/03/1996	pt recvd vax 15NOV95 & 16NOV95 called & stated became ill in PM of 15NOV95 & MD said pt had adverse vax event;pt stated had light h/a, nausea,sl shooting pain, even down to little toes;hx arthritis;exp hives				Y					Y	11/15/1995	11/15/1995	0		OTH	UNK	Nyquil	denies any @ this time	arthritis	~ ()~~~In patient		1						1	Headache; Malaise; Nausea; Pain; Urticaria	FLU3~PFIZER\WYETH~4958113~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0080855	01/16/1996	WA	37.0	37		M	12/18/1995	flu-like sxs w/hepatitis (inc LFTs, nl bili); arthralgias, myalgias, wt loss, fever, fatigue;				Y					U	10/15/1995	10/16/1995	1	EBV neg, CMV, PCR-blood; inc AST, ALT, ALK phos	OTH	OTH	NONE	NONE		~ ()~~~In patient		1						1	Arthralgia; Asthenia; Hepatic function abnormal; Hepatitis; Infection; Myalgia; Pyrexia; Weight decreased	FLU3~CONNAUGHT LABORATORIES~5F61116~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0080858	01/16/1996	IL	79.0	79		M	11/10/1995	pt recvd vax 4OCT95 & next day called reporting redness, low grade temp, entire upper arm-sore, felt shaky & soreness 2wks;redness subsided w/in 4 days;problems resolved completely by 20OCT95				Y					Y	10/04/1995	10/04/1995	0		PVT	PVT	Diazide,Lanoxin, Elavil, Taradil, Ansaid, Diprydamale	no acute illness	ASCVD, CHF, old MI	~ ()~~~In patient		1						1	Anxiety; Injection site hypersensitivity; Myalgia; Pyrexia; Tremor	FLU3~PARKE-DAVIS~00195P~7+~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~380956~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0080869	01/16/1996	CO	64.0	63		F	01/05/1996	pt recvd vax 25OCT95 & later devel numbness & tingling from mid upper lt arm to finger tips;feels sxs are cont & getting worse more constant & more overpowering; has appt w/neurologist 12JAN96				Y					N	10/25/1995	11/01/1995	7		PUB	PUB	Premarin	NONE	PCN, Percodan, Dolabid, Novacaine	NONE~ ()~~~In patient	CO96002	1						1	Hypoaesthesia; Paraesthesia	FLU3~PARKE-DAVIS~02165P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0080905	01/16/1996	MO	71.0	71		F	01/03/1996	severe pain in legs, feet, hands, arms;swelling-ankles, hands;redness-hands, feet, ankles;h/a, extremely tired, diff to walk;began subsiding last NOV & DEC;now free of sxs;									Y	10/17/1995	10/21/1995	4	25OCT95 rheumatoid factor 133; 6DEC95 Rheumatoid factor 34;	OTH	UNK	NONE	NONE		~ ()~~~In patient		1						1	Asthenia; Headache; Hypokinesia; Laboratory test abnormal; Myalgia; Osteoarthritis; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F1126~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0080908	01/16/1996	OH	25.0	25		F	12/29/1995	hives, immed responsive to antihistamines									Y	10/12/1995	10/12/1995	0		PVT	PVT	PPD by Connaught lot# 240211 given 12OCT95		klippel-feil;no allergies	NA~ ()~~~In patient		1						1	Urticaria	FLU3~PARKE-DAVIS~00195P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0080916	01/16/1996	KS				F	11/22/1995	10hr p/vax given pt noted severe pain in lt arm;2 days post inj raised red rash noted on lower extremities bilat									Y	11/17/1995	11/18/1995	1		PUB	PUB		NONE		~ ()~~~In patient	KS95063	1						1	Pain; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~5F61015~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0080926	01/16/1996	MI	66.0	66		M	12/08/1995	22NOV95 pt's sxs started w/muscle aches, diarrhea, weakness, sweats & tiredness;also c/o SOB;seen by pvt MD 4DEC95;no significant findings;pt cont to have flu like sxs;				Y					N	11/20/1995	11/22/1995	2		PUB	PUB	Synthroid, Lithium	NONE	hypothyroidism, manic depression, kidney disease	NONE~ ()~~~In patient	MI95147	1						1	Asthenia; Diarrhoea; Dyspnoea; Hyperhidrosis; Influenza; Myalgia; Somnolence	FLU3~PFIZER\WYETH~4958230~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~394936~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0080934	01/16/1996	TX	52.0	52		F	10/05/1995	c/o laryngitis, frequent soft stool, body aches, joint pain & alternating between hot & cold sensation from 24hrs p/vax;										10/02/1995	10/03/1995	1		PUB	PUB	NONE	NONE	asthma & allergies to dust, mold & grass	NONE~ ()~~~In patient	TXV96228	1						1	Arthralgia; Chills; Diarrhoea; Laryngitis; Myalgia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61119~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0080936	01/16/1996	ID	63.0	63		F		1NOV95 big blotch +- 3in below inj site;it's fiery red +- 20 red, puffy, hive-like blotches @ inj site;lower one is kind of puffy & not real hard;no fever, malaise									Y	10/26/1995	11/01/1995	6	NONE	OTH	PUB	NONE	NONE	allergic to PCN	NONE~ ()~~~In patient	ID95061	1						1	Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Rash maculo-papular; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61012~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1076B~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TTOX~CONNAUGHT LABORATORIES~5E71025~UNK~IM~RA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0080937	01/16/1996	GA	54.0	54		F	11/02/1995	pt to clinic on 2NOV95 @ 10:15 for nurse to check inj site;rt deltoid&upper arm w/erythema&edema;hot to touch;hard area w/2inch band extended from back arm to front arm;inc T;edema & erythema to ax of arm w/poss/?gland involvement;dizzy				Y						10/31/1995	10/31/1995	0		PUB	UNK		NONE	NONE	NA~ ()~~~In patient	GA96003	1						1	Dizziness; Injection site hypersensitivity; Injection site mass; Injection site oedema; Lymphadenopathy; Pyrexia; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4958133~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0536A~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0080938	01/16/1996	ID	55.0	55		F	11/03/1995	28OCT AM devel urticaria on trunk of body, macular rash went to hosp ER-told to take DPH;29OCT AM devel swollen tongue, airway obstruction to ER given short & long acting Epi				Y					Y	10/27/1995	10/28/1995	1		PUB	UNK		prior cold	latex allergy dx'd by allergist	NONE~ ()~~~In patient	ID95062	1						1	Dyspnoea; Rash maculo-papular; Respiratory disorder; Tongue oedema; Urticaria; Asthma; Dyspnoea; Hypersensitivity; Rash maculo-papular; Tongue oedema; Urticaria	FLU3~PFIZER\WYETH~4958125~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4958125~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0081292	01/16/1996	TX	50.0	50		F	12/13/1995	lightheadedness;nausea, drowsy (initial) w/in 12hrs; fever, congestion, body aches, joint pain 1wk later									Y	10/18/1995	10/20/1995	2	NONE	PVT	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Arthralgia; Dizziness; Myalgia; Nausea; Pharyngitis; Pyrexia; Rhinitis; Somnolence	FLU3~CONNAUGHT LABORATORIES~5F61119~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0081293	01/16/1996	TX	45.0			F	12/13/1995	initially chills, congestions, sneezing duration 6 to 7 hrs									Y					PVT	PUB	Premarin	NONE	NONE	NONE~ ()~~~In patient		1						1	Chills; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61119~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0081294	01/16/1996	TX	45.0	45		M	10/10/1995	c/o of sore throat, trunk pain, extreme fatigue									Y	10/05/1995	10/06/1995	1		PUB	PUB	NONE	NONE	diabetes, arthritis	NONE~ ()~~~In patient		1						1	Asthenia; Pain; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~5F61119~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0081295	01/16/1996	TX	24.0			F	12/13/1995	initially soreness @ site w/welt 24hrs later: sore throat, dizziness, drowsiness & body aches duration 1 wk;									Y				NONE	PVT	PUB	Tegretol	NONE	szs	NONE~ ()~~~In patient		1						1	Dizziness; Injection site pain; Myalgia; Pharyngitis; Somnolence	FLU3~CONNAUGHT LABORATORIES~5F61119~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0081296	01/16/1996	TX	50.0	50		F	12/13/1995	48hrs later joint pain, body aches, chills & fever, sore throat duration 72hrs;									Y	10/18/1995	10/19/1995	1	NONE	PVT	PUB	Premarin	NONE	NONE	NONE~ ()~~~In patient		1						1	Arthralgia; Chills; Myalgia; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61119~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0081297	01/16/1996	TX	44.0			F	12/13/1995	initially light headediness, dizzy, sneezing;24hrs later chills, fever, sore throat lasting for approx 2wks;									Y				NONE	PVT	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Chills; Dizziness; Pharyngitis; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61119~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0081298	01/16/1996	TX	54.0	54		F											Y	10/30/1995	11/01/1995	2		PUB	PUB	vitamins & premarin	NONE	NONE			1						1	Unevaluable event	FLU3~CONNAUGHT LABORATORIES~5F61119~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0081299	01/16/1996	TX	45.0	45		M	10/27/1995										Y	10/06/1995	10/20/1995	14	NONE	PUB	PUB	Seldane, Naprosyn PRN, Becovelent inhalent	NONE				1						1	Unevaluable event	FLU3~CONNAUGHT LABORATORIES~5F61119~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0079036	01/17/1996	NY	81.0	81		M	11/18/1995	flu like sxs w/in 4 days of flu shot; fever 103 for 7 days;loss of voice; weakness in legs; h/a;			Y						Y	10/28/1995	11/01/1995	4	NONE	PUB	PUB	Procardia-Lopressor	NONE	HTN	NONE~ ()~~~In patient	BA95045	1						3	Dysphonia; Headache; Influenza; Myasthenic syndrome; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61127~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Life Threatening	Influenza
0080944	01/17/1996	TX	39.0	39		M	11/07/1995	began feeling ill on 20OCT95 & was adm to hosp on Saturday & was there for 1 1/2 days; adm w/c/o fever, nausea, vomiting, diarrhea, hearing loss, ringing in the ears, chills, h/a, HTN;missed 5 days of work stated remained very weak;					Y	2			Y	10/18/1995	10/20/1995	2	serum blood sugars ran between 300-500mg/DL	PUB	PVT	apresoline, Lasix & verapamil	NONE other than chronic illness	allergic to PNC; hx of IDDM;HTN; renal disease;	allergic  rxn @ 35y/o w/flu vax;~ ()~~~In patient	TX95226	1						1	Asthenia; Condition aggravated; Deafness; Hyperglycaemia; Hypertension; Pyrexia; Tinnitus; Vomiting	FLU3~PFIZER\WYETH~4958077~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0080993	01/17/1996	TX	60.0	59		F	11/08/1995	pt recvd vax & inj burned a lot;by next day lt arm red & edematous from deltoid to elbow & cont to swell down into forearm & fingers for 5 days; arm red, hot; had flu like sxs x 4 days;									Y	10/24/1995	10/25/1995	1	NONE	PUB	PUB		NONE	allergy PCN & iodine	NONE~ ()~~~In patient	TX95231	1						1	Influenza; Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4958137~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0080994	01/17/1996	TX	42.0	42		F	10/19/1995	itching & rash on arms & legs									Y	10/19/1995	10/19/1995	0		PUB	OTH	Norvasc;Catapress patch	NONE	allergic to Neomycin, Pamalor, fresh strawberries & pineapple	NONE~ ()~~~In patient	TX95228	1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~5J61007~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0080997	01/17/1996	IA	61.0	61		M	12/28/1995	weak, dizzy, chest pain, cough, urinary discomfort				Y						12/26/1995	12/27/1995	1		PVT	OTH	Timoptic eye gtts	NONE	glaucoma	~ ()~~~In patient		1						1	Asthenia; Chest pain; Cough; Dizziness; Dysuria	FLU3~CONNAUGHT LABORATORIES~5F61096~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0081001	01/17/1996	NC	35.0	35		M	01/12/1996	19DEC95 c/o h/a, backache, myalgia, sore throat, cough, T100.8, P120, R24, BP 130/70; no rashes, lungs clear; beta strep screen neg;dx flu like synd s/p vaccination				Y					Y	12/14/1995	12/19/1995	5	beta strep neg	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Back pain; Cough; Headache; Influenza; Myalgia; Pharyngitis; Pyrexia	FLU3~PFIZER\WYETH~4958072~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0080003	01/18/1996	TX	54.0	54		M	01/12/1996	2 days /p vax pt exp sl redness @ inj site in lt arm;13NOV95 devel rt shoulder pain, fasiculations & some numbness & tingling in the ulnar;brachial plexitis;ulnar & radial weakness in rt arm;loss of finger movement;hand in claw position				Y				Y	N	10/06/1995	10/06/1995	0	limited MRI-exam incomplete/no obvious abn;sed rat=6;nl CXR: random blood sugar=200; CPK=281; TSH 12.05;glycohemoglobin 8.4 WNL;	PVT	OTH	Micronase, synthroid, glucophage, optipranolol, prozac		now-insulin dependent diabetes;glaucoma; hypothyroidism;transient intermittent trigeminal neuralgia;depression;granuloma of chest;allergy to PCN;	~ ()~~~In patient	0010150950288	1						2	Hypertonia; Hypokinesia; Injection site hypersensitivity; Muscle twitching; Neuritis; Neuropathy; Pain; Paraesthesia; Hypertension; Hypokinesia; Injection site hypersensitivity; Insomnia; Laboratory test abnormal; Myasthenic syndrome; Neuropathy; Paraesthesia; Hormone level abnormal; Hyperglycaemia; Injection site hypersensitivity; Laboratory test abnormal; Myalgia; Myasthenic syndrome; Neuropathy	FLU3~PARKE-DAVIS~00975P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~MERCK & CO. INC.~~1~~RA~PNEUMO (PNEUMOVAX)~2|FLU3~PARKE-DAVIS~00975P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~3|PPV~MERCK & CO. INC.~~1~~~PNEUMO (PNEUMOVAX)~3|FLU3~PARKE-DAVIS~00975P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~4|PPV~MERCK & CO. INC.~~UNK~IM~RA~PNEUMO (PNEUMOVAX)~4	USA	Disabling	Influenza
0080948	01/18/1996	NC	24.0	24		F	01/12/1996	dx of GBS;			Y		Y		Y		N	11/09/1995			unk	OTH	OTH		NONE	unk	~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLU3~PARKE-DAVIS~00885P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation	Influenza
0080954	01/18/1996	NJ	1.6	1	.6	F	01/10/1996	diffuse shaking (?rigors) (non epileptiform), no fever w/in 2hrs of vax;									Y	11/14/1995	11/14/1995	0		PVT	PVT	Zantac;Aerobid;Albuterol/intal neb inahler		reactive airway disease	~ ()~~~In patient		1						1	Chills; Tremor	FLU3~CONNAUGHT LABORATORIES~5G61023~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0080955	01/18/1996	MT	55.0	55		M	01/09/1996	16OCT95 pt recvd vax & exp inner arm pain-no moving arm;19OCT95 swelling over area diff raising arm;pain radiates down arm; tingles in ringing in little finger lt hand;				Y					N	10/16/1995	10/16/1995	0	EMG 4JAN96	PUB	OTH	NONE	NONE	lidocaine & Keflex	NONE~ ()~~~In patient		1						1	Hypoaesthesia; Hypokinesia; Injection site oedema; Pain; Paraesthesia; Hypokinesia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4958086~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4958086~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0080959	01/19/1996	NJ	81.0	81		M	01/15/1996	dx GBS;hospitalized 3-4 wks, now in rehab hosp;collapsed, unable to move, no movement in legs, late spread up arms, never on mechanical ventilation;treating neurologist @ hosp;					Y				U	11/16/1995	12/06/1995	20		OTH	OTH				~ ()~~~In patient	CO6429	1						1	Guillain-Barre syndrome; Hypokinesia; Hypotonia; Paralysis; Syncope	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0080967	01/22/1996	PA	52.0	52		M	12/21/1995	pt recvd vax 18NOV93 & 27NOV93 7AM pt exp numbness & tingling sensation in both arms;weakness progressed throughout the day &  hardly able to move extremities;gen weakness-stinging sensation;HTN BP 197/123;urinary incontinence;paresthesia				Y	Y	27		Y	N	11/18/1993	11/27/1993	9	x-ray c-spine fusion at c3-4 & c4-5 (old); MRI c-spine small disc herniation at c6-7;MRI thoracic spine small asymmetric bulging disc T10-11;MRI-lumbar spine unremarkable; Thoraco-lumb myelogram asymmetric bulging disc T10-11 w/moderate bon	PVT	PVT	Tenormin tablets	unk	pt suffered a broken neck & required cervical fusion 20yrs prior to ADE;also had a hx of HTN, hyperglycemia & palpitations	~ ()~~~In patient	896004001L	1						1	Hypertension; Hypothermia; Myasthenic syndrome; Myelitis; Neuropathy; Pain; Paralysis; Urinary incontinence	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0080975	01/22/1996	MO	55.0			F	01/11/1996	pt recvd vax OCT95 & w/in first four days, devel flu-like sxs;pt devel extreme muscle weakness;has been hospitalized 3x, & had not recovered as of the date of this report				Y	Y				N	10/01/1995	11/02/1995	32		OTH	OTH	unk	unk		~ ()~~~In patient	896012001L	1						1	Influenza; Myasthenic syndrome	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0080978	01/22/1996	CA	69.0	69		M	11/28/1995	per pt fever, no other sxs;					Y	1			Y	11/09/1995	11/18/1995	9		OTH	PUB				~ ()~~~In patient	CA95165	1						1	Pyrexia	FLU3~PFIZER\WYETH~4958136~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0081111	01/22/1996	CA				F	12/18/1995	localized immun rxn lt tricep, erythema;pain @ site c/o feeling dizzy, tired				Y					Y	10/18/1995	10/18/1995	0	MD exam x 2 only	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	CA960004	1						1	Asthenia; Dizziness; Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4958151~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0081126	01/22/1996	CA	67.0	67		F	12/05/1995	diarrhea x 1 x 24hrs									Y	10/28/1995	10/31/1995	3		PUB	PVT				~ ()~~~In patient		1						1	Diarrhoea	FLU3~PFIZER\WYETH~4958114~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081127	01/22/1996	CA	80.0	80		F	12/05/1995	t100.4-diarrhea;malaise x 48hrs;									Y	10/29/1995	11/01/1995	3		PUB	PVT				~ ()~~~In patient		1						1	Diarrhoea; Malaise; Pyrexia	FLU3~PFIZER\WYETH~4958114~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081128	01/22/1996	CA	69.0	69		M	12/05/1995	t99, diarrhea x 24hrs; Imodium & APAP									Y	10/29/1995	10/31/1995	2		PUB	PVT				~ ()~~~In patient		1						1	Diarrhoea; Pyrexia	FLU3~PFIZER\WYETH~4958114~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081129	01/22/1996	CA	84.0	84		F	12/05/1995	vomiting x 24hrs x 1									Y	10/26/1995	10/28/1995	2		PUB	PVT				~ ()~~~In patient		1						1	Vomiting	FLU3~PFIZER\WYETH~4958114~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081130	01/22/1996	CA	78.0	77		M	12/05/1995	vomiting x 1 x 24hrsp									Y	10/29/1995	11/01/1995	3		PUB	PVT				~ ()~~~In patient		1						1	Vomiting	FLU3~PFIZER\WYETH~4958114~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081131	01/22/1996	CA	75.0	75		M	12/05/1995	t100.4-APAP									Y	10/27/1995	10/29/1995	2		PUB	PVT				~ ()~~~In patient		1						1	Pyrexia	FLU3~PFIZER\WYETH~4958114~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081132	01/22/1996	CA	49.0	49		F		stiffness neck, h/a x 5d;chest pain, nausea, malaise;									Y	10/27/1995	10/28/1995	1		PVT	PVT				~ ()~~~In patient		1						1	Chest pain; Headache; Malaise; Nausea; Nuchal rigidity	FLU3~PFIZER\WYETH~4958114~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081133	01/22/1996	CA	20.0	20		F		had a h/a & nausea									Y	10/27/1995	10/29/1995	2		PVT	PVT				~ ()~~~In patient		1						1	Headache; Nausea	FLU3~PFIZER\WYETH~4958114~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081134	01/22/1996	CA	51.0	51		F		sick to the stomach;h/a; could not anything down;									Y	10/27/1995	10/28/1995	1		PVT	PVT				~ ()~~~In patient		1						1	Dyspepsia; Headache; Vomiting	FLU3~PFIZER\WYETH~4958114~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081135	01/22/1996	CA	32.0	32		F		stiff neck & back; h/a & sinus h/a; fever;sore throat;sore lower back & hips									Y	10/27/1995	10/29/1995	2		PVT	PVT		NONE		~ ()~~~In patient		1						1	Arthralgia; Headache; Myalgia; Nuchal rigidity; Pain; Pharyngitis; Pyrexia	FLU3~PFIZER\WYETH~4958114~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081136	01/22/1996	CA	48.0	48		F	12/05/1995	neck ache & stiff 3 days;sore spot in middle of chest, h/a for 3 days; APAP given									Y	10/27/1995	10/28/1995	1		MIL	PVT		NONE		~ ()~~~In patient		1						1	Headache; Myalgia; Nuchal rigidity; Pain	FLU3~PFIZER\WYETH~4958114~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081137	01/22/1996	CA	53.0	53		F		muscle's hurting, fever-rest									Y	10/27/1995	10/30/1995	3		PVT	PVT		NONE		~ ()~~~In patient		1						1	Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4958114~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081138	01/22/1996	CA	22.0	22		M		sore throat, stomach pains, runny nose, couldn't really eat cause food would come back up, swallowing was hard, throat was tight									Y	10/27/1995	10/30/1995	3		PVT	PVT		NONE		~ ()~~~In patient		1						1	Abdominal pain; Anorexia; Laryngospasm; Pharyngitis; Rhinitis	FLU3~PFIZER\WYETH~4958114~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081139	01/22/1996	CA	61.0	61		F		sore & stiff shoulders; body ache;nausea;tightness in chest;									Y	10/27/1995	10/29/1995	2		PVT	PVT				~ ()~~~In patient		1						1	Arthralgia; Chest pain; Myalgia; Nausea	FLU3~PFIZER\WYETH~4958114~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081140	01/22/1996	CA	29.0	29		F		pt was having fever & was taking APAP every six hrs for 2 days;									Y	10/27/1995	10/28/1995	1		PVT	PVT		NONE		~ ()~~~In patient		1						1	Pyrexia	FLU3~PFIZER\WYETH~4958114~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081141	01/22/1996	CA	41.0	40		F	12/06/1995	28OCT95 x 3 days severe sinus h/a, congestion, drainage & very stiff neck;partial recovery for about 4 days, then extreme weakness, fatigue, achiness, fever 101.6, h/a x3 days or so;during this period, 4 working days were missed;									Y	10/27/1995	10/28/1995	1	NA	PVT	PVT				~ ()~~~In patient		1						1	Asthenia; Headache; Myalgia; Nuchal rigidity; Pharyngitis; Pyrexia; Rhinitis	FLU3~PFIZER\WYETH~4958114~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081142	01/22/1996	CA	24.0	24		M		h/a, stomachache, dizziness									Y	10/27/1995	11/14/1995	18		PVT	PVT		NONE		~ ()~~~In patient		1						1	Abdominal pain; Dizziness; Headache	FLU3~PFIZER\WYETH~4958114~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081143	01/22/1996	CA	42.0	42		F		next day redness bubble @ inj site shoulder & elbow joints tender & warm rt arm-4th day abscess @ inj site painful to move shoulder & elbow & tight chest, sore throat;all joints aching-knees swelling-low back aching off & on;t100 x 4 days;									Y	10/27/1995	10/28/1995	1		PVT	PVT		NONE		~ ()~~~In patient		1						1	Abscess; Arthralgia; Chest pain; Injection site hypersensitivity; Nausea; Osteoarthritis; Pharyngitis; Pyrexia	FLU3~PFIZER\WYETH~4958114~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081144	01/22/1996	CA	59.0	59		F	12/06/1995	sick stomach not feeling well all over;pain on rt side into neck;redness & swelling below site;									Y	10/27/1995	10/27/1995	0		PVT	PVT		NONE		~ ()~~~In patient		1						1	Dyspepsia; Malaise; Oedema peripheral; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4958114~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081145	01/22/1996	CA	25.0	25		M		the sxs pt exp lasted 2 days;pt had terrible h/a, was achy all over; had the sweats & was extremely tired;had to rest for several hrs to have enough energy for about 30mins a/was exhausted again									Y	10/27/1995	10/28/1995	1		PVT	PVT		NONE		~ ()~~~In patient		1						1	Asthenia; Headache; Hyperhidrosis; Myalgia	FLU3~PFIZER\WYETH~4958114~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081146	01/22/1996	CA	73.0	73		F	11/14/1995	pt recvd vax 3NOV95 & 7NOV95 exp severe aching of legs, hips which prevented sleep;took APAP w/only fair relief;10NOV95 t100;had prev rxn to flu shot									Y	11/03/1995	11/07/1995	4	NONE	OTH	PUB	Procardia, ASA	denies	HTN, leaky mitral valve,s/p CVA	pt exp malaise, aching @ 73yo w/flu vax~ ()~~~In patient	CA960007	1						1	Arthralgia; Insomnia; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4958181~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081147	01/22/1996	CA	83.0	83		F	11/01/1995	noted redness w/swelling in a couple of hrs p/vax;next day redness, swelling, tenderness @ site of inj;pt was seen that day by MD;MD felt poss infect present;									Y	10/23/1995	10/23/1995	0		OTH	PUB	Vitamins, potassium, Zocor, Motrin	some arthritic discomfort;	ischemic heart disease, s/p CA lung, arthritis	~ ()~~~In patient	CA960002	1						1	Infection; Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Vasodilatation	FLU3~PFIZER\WYETH~4958151~4~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079903	01/23/1996	MI	43.0	43		M	12/05/1995	12hrs p/vax pt devel severe cramping in both legs;pt was unable to walk for 2 or 3 days; CPK 12,700;serum myoglobin 1700;renal function nl;									Y	10/28/1995	10/28/1995	0	CK 12,700;myoglobulin 1,700	OTH	OTH		NONE	NONE	~ ()~~~In patient		1						2	Blood creatine phosphokinase increased; Laboratory test abnormal; Muscle spasms	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0081069	01/23/1996	OH	30.0	30		F	01/18/1996	pt recvd vax & 2hrs later devel gen dark gray spots on skin followed by cold sxs;19NOV95 pt devel fever & diff breathing;20NOV95 pt was evaluated by MD & was adm to hosp w/dx of influenza;tx IV & IV ATB;d/c 25NOV95 w/Augmentin; t100.5				Y	Y	5			N	11/13/1995	11/13/1995	0	NONE reported	PVT	OTH	Propulsid, Zoloft, Ferrous sulfate, Cyclobenzaprine, Naproxen, albuterol solution, Proventil inhaler, Darvocet, Vicodin, Stadol, Ceftin, Midrin	NONE	LSE, scleroderma, rheumatoid arthritis, restrictive pulmonary disease, Raynauds disease, ITP, severe anemia, ulcer of throat, hiatal hernia, pulmonary fibrosis, systemic sclerosis;	~ ()~~~In patient	0010150960003	1						1	Condition aggravated; Drug ineffective; Dyspnoea; Infection; Pharyngitis; Pyrexia; Rhinitis; Skin discolouration	FLU3~PARKE-DAVIS~02065P~6~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0081075	01/23/1996	TN	2.0	2	.9	F	10/30/1995	t102 or 103R responds to APAP but fluctuates especially spikes when asleep, very irritable;devel pneumonia				Y					Y	10/28/1995	10/28/1995	0		PUB	PUB	Aerosal, Septra	NONE	asthma	fever w/pneumonia & flu shot~ ()~~~In patient	TN96010	1						1	Agitation; Drug ineffective; Infection; Pneumonia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~SMITHKLINE BEECHAM~~UNK~~~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0081272	01/24/1996	MO		0	.0	F	01/16/1996	4JAN96 pt recvd vax 26OCT95 & called today requesting flu vax  info- c/o neurological problems occurring 3 wks p/vax;				Y					U	10/26/1995				PVT	PVT		NONE	unk	~ ()~~~In patient		1						1	Urinary tract disorder	FLU3~PFIZER\WYETH~4958114~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0081275	01/24/1996	WA	41.0	41		F	11/01/1995	felt tingling in fingers when recvd vax in rt arm;4-5 hrs later lost strength in rt arm;unable to move arm & hold things in hand;@ present time able to hold some things in hand & use arm,but not for prolonged periods;stabbing pain rt arm;				Y						10/22/1995	10/22/1995	0	NA	OTH	OTH	NONE	NONE	had abd surgeries 10 yrs ago	NA~ ()~~~In patient		1						1	Arthropathy; Hypokinesia; Injury; Myasthenic syndrome; Pain; Paraesthesia; Tendon disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0081279	01/24/1996	OK	47.0	47		F	12/27/1995	w/in 48hrs pt started a scratchy sore throat w/in 3 days it was a bad cold that lasted 10 more days;worked x/1 afternoon									Y	11/06/1995	11/07/1995	1		OTH	PUB		NONE	NONE	NONE~ ()~~~In patient		1						1	Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0081282	01/24/1996	NE	59.0	59		M	01/18/1996	16OCT95 discomfort lt antecubital space followed by soreness lt foreman & edema lt wrist &  hand;30OCT95 subsequent resolution of discomfort but cont edema wrist & hand, gradually improving but unresolved as of 11JAN96;no lymphadenopathy									N	10/12/1995	10/16/1995	4	30OCT95: WBC 7.8, Hct 45.6, Plts 183,000, ESR 5;	PVT	PVT	ASA, Catopril, Metroprolol	NONE	coronary heart disease, coronary art stents, hx of malaria	~ ()~~~In patient		1						1	Arthralgia; Myalgia; Oedema peripheral; Osteoarthritis; Red blood cell sedimentation rate decreased	FLU3~CONNAUGHT LABORATORIES~5F61145~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0081287	01/24/1996	NY	44.0	44		F	01/19/1996	pt devel hives on face & arms around 6PM on 1NOV95;half of face was swollen;next am devel h/a, back pain, fever, diarrhea, swollen/painful glands & herpes simples I									Y	11/01/1995	11/01/1995	0	NONE	OTH	PUB	NONE	NONE	herpes simplex I	NONE~ ()~~~In patient		1						1	Back pain; Diarrhoea; Face oedema; Headache; Herpes simplex; Lymphadenopathy; Pyrexia; Urticaria	FLU3~PFIZER\WYETH~4958125~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081289	01/24/1996	WA	81.0	81		M	10/30/1995	had sore throat the day p/vax w/ flu shot;had an elevated temp yesterday but not as bad as wife's rxn;advised to see PMD										10/26/1995	10/26/1995	0		PUB	PUB	NONE	NONE	NONE	NA~ ()~~~In patient	WA951201	1						1	Pharyngitis; Pyrexia	FLU3~PFIZER\WYETH~4958112~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081290	01/24/1996	WA	70.0	70		F	10/30/1995	pt stated that w/in 1hr p/vax devel sore throat & t101;pt coughing up large amounts of phlegm;since then has temp of 101 in morning-lower towards evening;advised to see PMD;										10/26/1995	10/26/1995	0		PUB	PUB	Tagamet	NONE	NONE	NA~ ()~~~In patient	WA951202	1						1	Cough; Pharyngitis; Pyrexia	FLU3~PFIZER\WYETH~4958112~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081291	01/24/1996	WA	69.0	69		F	01/09/1996	pt called to say that had recvd very painful flu shot on 2JAN96 & w/in 24hrs had numbness in the skin between index finger & long finger on lt hand;pt stated hand not painful only skin was numb;took Motrin									U	01/02/1996	01/03/1996	1	NA	PUB	PVT	NONE	NONE	allergic to milk;wheat, pine needles;prev problems w/neck/shoulder	NA~ ()~~~In patient	WA961208	1						1	Injection site pain; Paraesthesia; Pruritus	FLU3~PFIZER\WYETH~4958112~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081398	01/29/1996	OR	48.0	48		M	01/05/1996	pt recvd vax 17OCT95 & pt was hospitalized w/partial paralysis;neurologist dx transverse myelitis;pt was to be discharged on 5JAN95;					Y	1			U	10/17/1995	01/04/1996	79		PUB	PVT	unk	unk		~ ()~~~In patient	896011008L	1						1	CSF test abnormal; Coordination abnormal; Gait disturbance; Laboratory test abnormal; Myasthenic syndrome; Myelitis; Paraesthesia; Paralysis	FLU3~PFIZER\WYETH~4958125~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0081405	01/29/1996	UT	92.0	91		F	12/06/1995	pt recvd vax on 15OCT95 & came down w/flu;came down w/bad sore throat the next morning;4 days later lung congestion-had to go to MD & take ATB lasted 2 1/2wks;				Y					Y	10/15/1995	10/16/1995	1		PUB	OTH		NONE		NONE~ ()~~~In patient	UT961802	1						1	Drug ineffective; Infection; Influenza; Lung disorder; Pharyngitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0081415	01/29/1996	MD	39.0	39		F	12/27/1995	woke up 21DEC95-w/nausea, mild abd pain x 1 1/2days, low grade temp, soreness in joint (all) on 24DEC95 started w/upper resp congestion (nasal) w/yellow discharge from nose going down into chest;				Y					N	12/19/1995	12/21/1995	2	has MD appt 27DEC-no test done yet	OTH	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	PA95223	1						1	Abdominal pain; Arthralgia; Lung disorder; Lymphadenopathy; Malaise; Nausea; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61024~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0081421	01/29/1996	MD	73.0	73		F	10/27/1995	c/o fever (did not take temp), chills & dizziness;took a Motrin;felt better in 1 1/2-2hrs;(pt was reluctant to report, but did so on advice of daughter who works @ hlth dept									Y	10/25/1995	10/25/1995	0	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MD95047	1						1	Chills; Dizziness; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61120~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0081459	01/30/1996	AR	3.0			F	01/30/1996	pt recvd vax & exp febrile convuls leading to brain damage p/vax;OCT95 pt exp sz d/t dehydration & low sodium & was adm to hosp x3-4days;28OCT95 exp diarrhea & resp illness including fever;t106;pt exp sz & coma resulted in 3/4 brain damage;					Y	86		Y	N	10/28/1995	10/31/1995	3	NONE	PUB	OTH	unk	febrile	premature birth w/trachial tube in place	~ ()~~~In patient	ALI96031	1						1	Coma; Convulsion; Delirium; Diarrhoea; Hyponatraemia; Lung disorder; Pyrexia; Respiratory disorder	FLU3~PFIZER\WYETH~4858102~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0081460	01/30/1996	NJ	68.0			F	01/25/1996	pt recvd vax 6NOV95 & 11NOV95 exp fever, cough & dx w/pneumonia 21NOV95;dx w/pericarditis 22NOV95 & hospitalized 2DEC95 w/carditis, pneumonitis & atrial fibrillation					Y	10			Y	11/06/1995	11/11/1995	5	abn EKG noted	PVT	OTH	unk		hx of hypercholesterolemia	~ ()~~~In patient	0010150950295	1						1	Atrial fibrillation; Cough; Infection; Pericarditis; Pneumonia; Pyrexia	FLU3~PARKE-DAVIS~00785P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0081461	01/30/1996	CT	74.0	73		F	01/16/1996	pt recvd vax 16NOV95;19NOV95 noted general weakness & canker sore in mouth;notified MD but declined to go to office because of weakness;next day husband found pt dead;	Y	11/20/1995							N	11/16/1995	11/19/1995	3		PVT	PVT	unk	urinary tract infect	pt may have been taking Macrodantin for a urinary tract infect @ the time of death	~ ()~~~In patient	896017020L	1						1	Asthenia; Mouth ulceration; Asthenia; Headache; Mouth ulceration; Pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Results in Death	Influenza
0081462	01/30/1996	NY	87.0	87		F		w/in a few days had loss of nl activity-sleeping;c/o noc sweats, gen weakness-then able to walk & move normally;severe weakness w/fever spiking to 102;given ATB					Y				U	10/17/1995	10/24/1995	7	blood cultures-no growth p/24hrs	PUB	PUB		NONE	cardiac problems-mitral valve prolapse & CHF	~ ()~~~In patient	NYS95064	1						1	Asthenia; Hyperhidrosis; Hypokinesia; Pyrexia; Somnolence; Stupor	FLU3~PARKE-DAVIS~01595P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0081470	01/30/1996	MI				M		pt recvd vax & was dx w/GBS;									U	10/31/1995	10/31/1995	0	NONE reported	OTH	OTH	unk	NONE	NONE	~ ()~~~In patient	ALI96032A	1						1	Guillain-Barre syndrome	FLU3~MEDEVA PHARMA, LTD.~E2715HD~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0081471	01/30/1996	MI	59.0			M		pt recvd vax 2NOV95 & wax dx w/GBS;				Y	Y				U	11/02/1995	11/22/1995	20	NONE reported	OTH	OTH	unk	NONE	NONE	~ ()~~~In patient	ALI96032B	1						1	Abdominal pain; CSF test abnormal; Eye disorder; Facial palsy; Guillain-Barre syndrome; Myasthenic syndrome; Nystagmus; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E2725HF~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0081472	01/30/1996	NY	41.0	41		F	12/04/1995	immed pain in deltoid muscle p/inj;pain cont still in deltoid region only;seen by MD x2				Y						11/03/1995	11/03/1995	0		PUB	PUB	vit	sz disorder	sz disorder	NONE~ ()~~~In patient	NYS95074	1						1	Injection site pain	FLU3~MEDEVA PHARMA, LTD.~01185P~5~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0081478	01/30/1996	NM	44.0	44		F	01/16/1996	devel pain immed w/numbness & tingling w/in 30mins of inj;tx w/DPH & ice;pain subsided numbness cont 4wks later, cyclical, burning, waves of pain from elbow to hand;treated in ER w/percocet & flexeril;pain lessened, began P.T. for 4wks;				Y					Y	10/12/1995	10/12/1995	0	EMG-critical weakness involving triceps muscle suggesting isolated injury to @ least a branch of the fiber to a portion of triceps	PUB	PVT		NONE		~ ()~~~In patient		1						1	Hypoaesthesia; Laboratory test abnormal; Myasthenic syndrome; Pain; Paraesthesia	FLU3~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0081481	01/30/1996	NY	65.0	65		F	11/20/1995	localized redness & swelling @ site;both arms swollen & pink;swelling of face, congestion, SOB, emesis x 1;									Y	11/02/1995	11/02/1995	0		OTH	OTH	multiple	multiple sclerosis	allergies sulfa, PCN, cephalosporin, Gentamicin	~ ()~~~In patient	NYS95073	1						1	Dyspnoea; Face oedema; Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Rhinitis; Vasodilatation; Vomiting	FLU3~PFIZER\WYETH~4958087~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081483	01/30/1996	NY	73.0	73		F	10/25/1995	23OCT95 930PM t100.2,large amount of yellow oral secretions;1215AM large amount of emesis,t103.5,P140,R44,02 on;MD notified DPH given & APAP supp given									Y	10/23/1995	10/23/1995	0	none dones since pt became afeb & condition returned to nl w/in 8hrs	OTH	PUB	Cardizem;Reglan, Lasix, NPH insulin	NONE	s/p brain stem CVA-hypertension;end stage alzheimers-GT fed-hx recur asp pneumonia	~ ()~~~In patient	NYS95061	1						1	Hyperventilation; Pyrexia; Respiratory disorder; Salivary hypersecretion; Tachycardia; Vomiting	FLU3~PFIZER\WYETH~4958119~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081652	01/31/1996	MA	67.0	67		M	01/11/1996	1-2wk a/Thanksgiving devel dec muscle strength & tingling in all extremities but most pronounced on the rt; couldn't raise either arm, balance became poor;had fallen w/no apparent injury 1NOV95;MRI, spinal all neg;dec strength, weakness				Y					N	10/24/1995	11/09/1995	16	CBC-nl; immunoelectrophoresis-nl; poliovirus antibody neg;reflexes were absent in upper extremities;sup abd reflexes absent	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MA9602	1						1	CSF test abnormal; Guillain-Barre syndrome; Hypokinesia; Hyporeflexia; Injury; Myasthenic syndrome; Neuropathy; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~5F61134~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0083166	01/31/1996	OH	8.0	8		M		pt recvd vax 1NOV95 & 9NOV95 pt who was the 4th of 5 children, whom all had natural chickenpox, devel 3 chicken pox lesions on face;No further details were provided;									U	11/01/1995	11/09/1995	8	No relevant data;	OTH	OTH	Dilantin, Depakene		palsy, cerebral; epilepsy; visual disturbance	~ ()~~~In patient	WAES95110810	1						1	Dermatitis bullous	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~~PNEUMO (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~~1~~~VARICELLA (VARIVAX)~1	USA		Influenza
0083330	01/31/1996	MO	2.0	2	.5	F		pt recvd vax;9nov95 devel 5-6 gen chicken pox like lesions w/ no fever; dx w/ chicken pox;									Y	11/02/1995	11/09/1995	7	no relevant data	UNK	UNK					WAES95120218	1						1	Dermatitis bullous; Drug ineffective; Infection	FLU3~CONNAUGHT LABORATORIES~SF61113~4~~~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~~4~~~VARICELLA (VARIVAX)~1	USA		Influenza
0081696	02/01/1996	WA	38.0	38		M	12/26/1995	pt c/o throat sore, breathing diff x 1min-head pain & tooth pain on rt side inj on lt deltoid;pt was observed during entire time pt refused to stay for longer than 5mins observation									U	12/26/1995	12/26/1995	0	NKA	PUB	OTH	Haldol;codeine cough syrup	recuperating from cold	NKA	NKA~ ()~~~In patient		1						1	Dyspnoea; Headache; Pain; Pharyngitis	FLU3~PFIZER\WYETH~4958112~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081697	02/01/1996	CA	78.0	78		U	12/28/1995	pt recvd vax;devel 1cm lesion red-2 on 15OCT95 rt leg-spread up legs & thighs x2-3days;pruritic;pt had rash 1wk;inflammatory papules sl eczematous;poss allerg dermatitis-erythema multiforme-diarrhea-vasculitis-CHF;exp tremors;meds given				Y						10/13/1995	10/15/1995	2	22NOV95 BP 185/80	UNK	UNK	Micronase;Verapamil;Lasix;Doxipin;CKL;Indomethacin;Tenormin;Ogen;Colahicine;Clorazepate;Betaptic;Vancenase;			~ ()~~~In patient		1						1	Diarrhoea; Eczema; Erythema multiforme; Hypersensitivity; Hypertension; Pruritus; Right ventricular failure; Vasculitis	FLU3~PFIZER\WYETH~4958138~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0081699	02/01/1996	MA	27.0	27		F	01/16/1996	local rxn below inj site 5x8cm;redness, heat, swelling, & pain; cellulitis @ inj site;										12/28/1995	12/30/1995	2	NONE	UNK	UNK				pt recvd flu shot last yr w/o problems;~ ()~~~In patient		1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4958076~UNK~A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEPA~SMITHKLINE BEECHAM~~UNK~A~~HEP A (HAVRIX)~1	USA		Influenza
0081703	02/01/1996	MO	36.0			F		24hrs p/vax pt started hives on trunk & arms, gen itching;no wheezing, facial or airway tightness or swelling;										11/14/1995	11/15/1995	1	NONE	UNK	UNK	PCN, Xylocaine, Erythromycin			~ ()~~~In patient		1						1	Pruritus; Urticaria	FLU3~PFIZER\WYETH~4958108~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081708	02/01/1996	NE	44.0	44		M	11/16/1995	sore muscle around inj site & up into neck;small whelps formed on lower neck;disappeared in 48hrs;									Y	10/16/1995	10/16/1995	0		PUB	PVT		NONE	NONE	~ ()~~~In patient		1						1	Myalgia; Urticaria	FLU3~PFIZER\WYETH~4958118~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081709	02/01/1996	NE	32.0	32		M	01/26/1996	high temp, n/v									Y	11/07/1995				PUB	PVT		high temp, n/v	HIV+	~ ()~~~In patient		1						1	Nausea; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~4958118~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081710	02/01/1996	NE	49.0	49		F	11/16/1995	pt recvd vax in lt arm;next day had extreme pain in lt side of head,neck & shoulder & arm									Y	10/18/1995	10/19/1995	1		PUB	PVT			asthma, pollen allergies, no spleen	~ ()~~~In patient		1						1	Headache; Myalgia; Neck pain; Pain	FLU3~PFIZER\WYETH~4958118~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0081711	02/01/1996	NE	40.0	40		F	11/28/1995	approx 4 to 5hrs p/vax itching noted-on exam hives noted-legs, feet, arms, lower abd (initially itching @ site of inj which passed p/1 1/2 to 2hrs);rash cont x 5 days;reported to family MD 10NOV95;Pred for relief then recovered;									Y	11/06/1995	11/06/1995	0		PUB	PVT	Zoloft;Cardura	NONE	allergy to Anaprox	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Rash; Urticaria; Urticaria	FLU3~PFIZER\WYETH~4958118~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4958118~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0081743	02/02/1996	MA	64.0	64		F	11/30/1995	2-3 days post flu shot devel red, rash-like swelling starting @ site of shot  & slowly progressed to chest, arms & legs;denies h/a, fever or diff breathing;MD put on Pred				Y					Y	10/26/1995				PUB	PUB	Zestril, Norvasc, topical hydrocortizone	denies	eczema-like condition of legs only	pt has had flu shot a/w/no rxn~ ()~~~In patient	MA9601	1						1	Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Rash maculo-papular; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61134~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0084289	02/02/1996	NE	36.0	36		F	10/27/1995	pt recv vax 24OCT95 & 12-24hrs devel an inj site rxn characterized as red,raised,warm & 3 inches in circumference									Y	10/24/1995	10/24/1995	0		PVT	PVT	unk	unk		~ ()~~~In patient	896039027L	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4958137~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0080955	02/06/1996	MT	55.0	55		M	01/09/1996	16OCT95 time of inj small amount pain-on moving arm;17OCT95 swelling & redness over area;diff raising arm;3JAN96 pain radiates down arm-tingles in finger (lt hand & palmer surface lt hand);				Y					U	10/16/1995	10/16/1995	0	EMG 4JAN96	PVT	OTH	NONE	NONE	lidocaine skin reaction-no reflux	NONE~ ()~~~In patient		1						2	Hypoaesthesia; Hypokinesia; Injection site oedema; Pain; Paraesthesia; Hypokinesia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4958086~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4958086~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0081939	02/06/1996	CA	28.0	28		F	01/18/1996	pt recvd vax 20NOV93 & mother-in-law reports pt hospitalized 25JAN94 dx of GBS made;pt has been hospitalized several times since then;					Y				N	11/20/1993	01/25/1994	66		OTH	OTH	unk	NONE		~ ()~~~In patient	896022008L	1						1	Diarrhoea; Guillain-Barre syndrome; Hypotension; Influenza; Syncope; Vomiting; Weight decreased	FLUX~PFIZER\WYETH~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0081958	02/06/1996	IL	58.0	58		F	01/09/1996	felt achy 7 nasally;tired;very sick next evening,nauseous,vomiting,copious diarrhea,weakness,tiredness & achiness cont									Y	10/24/1995	10/26/1995	2		PUB	PUB	NONE	NONE	NONE	pt exp rxn several yrs ago for several yrs;recvd .5 dose 2times one mo apart;~ ()~~~In patient	IL960011	1						1	Asthenia; Diarrhoea; Malaise; Myalgia; Nausea; Rhinitis; Vomiting	FLU3~CONNAUGHT LABORATORIES~5F61148S~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0082177	02/08/1996	CA	14.0	14		M	01/26/1996	ascending paresthesias w/weakness b/l legs;resp compromise resolved over 4wk period;				Y						10/31/1995	11/07/1995	7		PVT	OTH	TCN; Li		acne, bipolar disorder	~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome; Paraesthesia; Respiratory disorder	FLU3~PFIZER\WYETH~4958129~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0082187	02/08/1996	OH	37.0	37		F	01/25/1996	pt recvd vax 26OCT95 lt arm;pt devel pain,about a 20cm erythema,rash & itchy;poss allerg rxn										10/26/1995	10/26/1995	0	NA	UNK	UNK	NA	NA	NA	~ ()~~~In patient		1						1	Hypersensitivity; Injection site hypersensitivity; Injection site pain; Pruritus; Rash	FLU3~PFIZER\WYETH~4958117~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0082188	02/08/1996	ID	53.0	53		F	01/29/1996	pt recvd flu vax 6OCT95 & 10 days p/vax exp redness & swelling & warmth @ site-went to neck & shoulder (soreness);c/o lt arm, shoulder, back pain cont-pt feels sick;?abscess;pos influenza synd by flu shot;neuropathy, tingling, weak, dx UTI										10/06/1995	10/17/1995	11	BP 144/92R; t97.9;P96; urine cult 1.005; UA clear;CBC neg; EKG 2 bact; urine C/S	UNK	UNK			insulin dep-diabetes	~ ()~~~In patient		1						1	Abscess; Influenza; Injection site hypersensitivity; Injection site oedema; Neck pain; Neuropathy; Pain; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0082189	02/08/1996	CA	43.0			F	12/18/1995	pt recvd vax; devel erythema, induration & tenderness; 2 in diam at inject site w/ edema of fingers of affected arm;										11/11/1995	11/13/1995	2	n/a	UNK	UNK			none known	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Oedema peripheral	FLU3~PFIZER\WYETH~4958117~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0082192	02/08/1996	WI	57.0	57		F	01/25/1996	pt recvd vax;on 15oct94 onset of granulomatous anterior uveitis (of eyes) 2 days p/ flu shot in rt & lt eye;tx w/ steroids drops & recovered									Y	10/15/1994	10/15/1994	0	hesto blasto, coccodiomyosis, lepto spirosis, chest x-ray, APPD, lymes, all neg;	UNK	UNK			newly discovered diabetic; gamma GT + X2;	~ ()~~~In patient		1						1	Granuloma; Uveitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0082317	02/12/1996	IL	32.0	32		F	02/05/1996	CFS-chronic fatigue synd;extreme fatigue, memory impairment, extreme muscle pain								Y	N	11/01/1988	11/01/1988	0		OTH	OTH		CFS-chronic fatigue synd	childhood asthma, endometriosis	NONE~ ()~~~In patient		1						1	Amnesia; Asthenia; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0082318	02/12/1996	CA	27.0	27		F	02/03/1996	pt dx w/GBS approx 2months post vax					Y				N	10/29/1995	12/27/1995	59	LP treated by another @ this time	PVT	OTH		NONE	sinustitis, CMT	~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLU3~PFIZER\WYETH~4958111~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0082319	02/12/1996	WI	56.0	56		F	12/27/1995	chills, achy bones, stomach pain between ribs, esophagus raw;hospitalized d/t severe pain					Y	1			Y	10/23/1995	10/24/1995	1		PUB	PUB	hormones only	NONE	NONE	NONE~ ()~~~In patient	WI95066	1						1	Abdominal pain; Bone pain; Chills; Oesophagitis; Pain	FLU3~MEDEVA PHARMA, LTD.~2825HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0082326	02/12/1996	WI	46.0	46		F	12/28/1995	lt am edematous x 2 size-w/in 24hrs was cool, numb, lost feeling & pain hurt like the devil;tx DPH w/relief-swelling x 72hrs-dec during that time;				Y					Y	12/07/1995	12/08/1995	1	NONE	PUB	PUB	Vasotec	NONE	NONE	~ ()~~~In patient	WI95075	1						1	Chills; Oedema peripheral; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4958100~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~394936~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0082333	02/12/1996	WI	96.0			F	12/06/1995	pt c/o sore arm few days p/vax which worsened w/redness, swelling & inc pain;saw MD 15NOV95; on 7DEC95 area has red papular healing rash; no swelling, some soreness;				Y					Y	10/25/1995	10/27/1995	2	NONE	PUB	PUB	propoxyphene for arthritis	NONE	hx of osteoarthritis, angina	~ ()~~~In patient	WI95068	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Rash maculo-papular	FLU3~PARKE-DAVIS~00975P~7+~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0082405	02/13/1996	CO	70.0	70		F	02/05/1996	pt recvd vax & had sore & tender feet on 4DEC95 by 15JAN96 devel numbness thought to be diabetic neuropathy however presented 19JAN,22JAN & 29JAN w/progressive numbness in lower extremities;adm to hosp 29JAN then to nursing home for rehab					Y	5			U	11/06/1995	12/04/1995	28		PVT	PVT	KCL, micronase, Trimillerene, alleporinal	diabetes, HTN	diabetes, HTN	~ ()~~~In patient		1						1	Guillain-Barre syndrome; Neuropathy; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4958116~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0082437	02/13/1996	FL	78.0	78		M	02/07/1996	1st noc-congested,nl during next day;2nd noc & following 3 days-99-100 temp & aches in hands & arms just above elbows;gradual improvement followed;pt stayed in bed,drank water & juices,ch. soup									Y	10/02/1995	01/17/1996	107	NA	OTH	PUB			PCN	NA~ ()~~~In patient		1						1	Myalgia; Pharyngitis; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0082445	02/13/1996	AK	38.0	38		M	02/01/1996	c/o dizzy w/cramping in abd;IV fluids/IV Toradol									Y	02/01/1996	02/01/1996	0	NA	OTH	MIL		NONE		NA~ ()~~~In patient		1						1	Abdominal pain; Dizziness	FLU3~PFIZER\WYETH~4958207~5~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEPA~SMITHKLINE BEECHAM~VHA441A6~1~IM A~~HEP A (HAVRIX)~1|TD~CONNAUGHT LABORATORIES~5B71032~4~IM A~~TD ADSORBED (NO BRAND NAME)~1|TYP~PFIZER\WYETH~4958217~4~SC A~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0082446	02/13/1996	MA	50.0	50		M	02/01/1996	pt recvd vax & saw a scotomatous area in lt visual field,went to ER;dx viral induced papillitis;				Y						10/25/1995	11/13/1995	19	Vfields & clinical picture	PVT	OTH	NONE		NONE	NA~ ()~~~In patient		1						1	Infection; Optic neuritis; Visual field defect; Blindness; Infection; Optic neuritis; Visual field defect	FLU3~PFIZER\WYETH~4958090~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4958040~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0082670	02/16/1996	NY	60.0	60		M	02/12/1996	3FEB96 rhinitis x 3 days;7FEB96 numbness in hands & feet;seen in ER inc numbness & fatigue,malaise-presently dx w/GBS on a ventilator;	Y		Y		Y				N	10/18/1995	02/07/1996	112		PVT	PUB		NONE		~ ()~~~In patient		1						1	Apnoea; Asthenia; Guillain-Barre syndrome; Malaise; Paraesthesia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61134~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0082738	02/20/1996	NY	74.0	74		M	01/29/1996	pt recvd vax; exp auditory hallucinations;					Y					10/12/1995	10/15/1995	3		OTH	OTH	metoprolol; ASA; diltiazem hd; nitroglycerin			~ ()~~~In patient		1						1	Hallucination	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0082743	02/20/1996	CO	22.0	22		F	01/26/1996	pt recvd vax;skin color became extreme pallor;felt faint;pt then had tonic type sx involving arms & legs,lasted approx 15-20 seconds;BP 60/40;P 44;placed on exam table to  lie;diaphoretic;BP inc to 108/60 and P 72;									Y	01/25/1996	01/25/1996	0	none	PUB	PUB		none	nka	~ ()~~~In patient	CO96020	1						1	Bradycardia; Convulsion; Hyperhidrosis; Hypotension; Pallor; Syncope	FLU3~MEDEVA PHARMA, LTD.~E27225HE~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|OPV~PFIZER\WYETH~0733H~UNK~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~1|TD~CONNAUGHT LABORATORIES~4H6156~UNK~IM~LL~TD ADSORBED (NO BRAND NAME)~1|YF~CONNAUGHT LABORATORIES~5F61061~UNK~SC~LA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0082752	02/20/1996	WA	33.0	33		F	11/06/1995	pt recvd vax; w/in 1 hr of vax, had large red lump on arm;iced it;on deltoid, area of contusion w/ central 1.3x1.0cm firm area;										10/24/1995	10/24/1995	0	none	OTH	OTH	durarent, rhinocort;	none	multiple environment allergies; hay fever, mild asthma;	~ ()~~~In patient	WA951195	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0082761	02/20/1996	WA	73.0	73		F	12/12/1995	pt recvd vax; exp dizziness, cramping, d; 2 days later malaise, yeast infect, itching vaginal severe; HA;				Y					Y	11/06/1995	11/06/1995	0		PUB	PVT		none	sensitive to meds, bee; bee stings;	in son, same sxs p/ flu vax;~ ()~~~In patient	WA951197	1						1	Diarrhoea; Dizziness; Headache; Malaise; Pain; Pruritus; Vaginal infection	FLU3~PARKE-DAVIS~00675P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0080062	02/21/1996	MN	12.0			M		pt recvd vax; probable GBS;					Y					10/13/1995	11/14/1995	32	urine for hvy metals neg; spinal tap neg;	UNK	UNK	Proventil, tylenol w/codeine			~ ()~~~In patient		1						2	Conversion disorder; Guillain-Barre syndrome; Paralysis	FLU3~PFIZER\WYETH~4958081~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0082849	02/21/1996	OH	1.0	1	.0	F	02/16/1996	t101.2, whiny-runny nose w/in a few days devel rash-became lethargic-had diff standing-did not feel well;			Y	Y					N	02/07/1996	02/07/1996	0	NONE	OTH	OTH	fluoride drops	NONE	NONE	pt exp temp~ ()~~~In patient		1						1	Arthralgia; Hypokinesia; Otitis media; Personality disorder; Pyrexia; Rash; Rhinitis; Somnolence	FLU3~MEDEVA PHARMA, LTD.~429321~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|MMR~MERCK & CO. INC.~0200B~1~L~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Life Threatening	Influenza
0082869	02/21/1996	ME	55.0	54		M		red swollen painful arm-fever, sweating, nausea;									Y	11/28/1995	11/28/1995	0	NONE	PVT	PVT		nONE	s/p MI	pt's sibling exp rxn w/Td~ ()~~~In Sibling		1						1	Hyperhidrosis; Injection site hypersensitivity; Injection site oedema; Nausea	FLU3~CONNAUGHT LABORATORIES~5F61135~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~428996~1~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0082972	02/23/1996		37.0			F	02/19/1996	pt recvd vax; severe pain shoulders , neck & HA; loss of mobility neck; loss of short term memory											10/13/1995		MRI C-S neg;	UNK	UNK				~ ()~~~In patient		1						1	Amnesia; Headache; Hypertonia; Nuchal rigidity; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0078741	02/25/1996	IL	32.0	32		M	10/31/1995	pt recv vax 23OCT95 & same day pt devel a sore throat,lightheadedness,labored breathing,body aches,a fever of 100 anorexia & local rxn 2inches in diameter surrounding one of the inj sites;pt felt rxn was like bronchitis;biaxin given				Y					U	10/23/1995	10/23/1995	0		PVT	OTH	unk	unk		~ ()~~~In patient	895337003L	1						2	Anorexia; Bronchitis; Dizziness; Dyspnoea; Injection site reaction; Myalgia; Pharyngitis; Pyrexia	FLU3~PFIZER\WYETH~4958132~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~394963~1~IM~LA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0078615	02/26/1996	NY	50.0	50		F	11/02/1995	pt recv vax;devel inject site rxn characterized by erythema,warmth & swelling;									U	10/24/1995	10/24/1995	0		OTH	OTH	hydrochlorothiazide;KCL;Procardia XL;	NONE	NKDA;HTN;	~ ()~~~In patient	895318024L	1						2	Injection site hypersensitivity; Injection site oedema; Vasodilatation; Injection site hypersensitivity; Vasodilatation	FLU3~PFIZER\WYETH~4958082~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|FLU3~PFIZER\WYETH~4958082~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~3	USA		Influenza
0078615	02/26/1996	NY	42.0	42		F	11/02/1995	pt recv vax;devel an inject site rxn characterized by warmth & erythema 4x6cm in size;									U	10/24/1995	10/25/1995	1		OTH	OTH		NONE	allergy-talwin & Darvon, SLE;	~ ()~~~In patient	895318025L	1						3	Injection site hypersensitivity; Injection site oedema; Vasodilatation; Injection site hypersensitivity; Vasodilatation	FLU3~PFIZER\WYETH~4958082~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|FLU3~PFIZER\WYETH~4958082~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~3	USA		Influenza
0078640	02/26/1996	PA	28.0	28		F	10/26/1995	pt recv vax 23OCT95 & w/in 5mins of inj pt devel facial numbness (cheek & upper neck,initially both sides,w/rt sided numbness resolving on 24OCT95);pt also devel facial edema on 26OCT95 & facial flushing-hot to touch no redness;tx ER				Y					Y	10/23/1995	10/23/1995	0		PVT	PVT	unk	NONE		~ ()~~~In patient	895336010L	1						2	Face oedema; Facial palsy; Paraesthesia; Vasodilatation; Vasospasm	FLU3~PFIZER\WYETH~4958113~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0078767	02/26/1996	OK	43.0	43		F	11/03/1995	pt recv vax 19OCT95 & c/o diff moving arm & weakness in grasp (though never complete loss of sensation or function);pt had to use rt arm to assist moving lt arm;dx brachial plexus neuropathy;									N	10/19/1995	10/28/1995	9		PVT	PVT	levothyroxine tablets oral	NONE	hypothyroidism	~ ()~~~In patient	895336009L	1						2	Hypokinesia; Myasthenic syndrome; Neuropathy	FLU3~PFIZER\WYETH~4958077~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0079973	02/26/1996	MS	33.0	32		F	11/08/1995	pt recvd vax;devel flushing sensation,blanched color and SOB 3-4 min p/ vax;was given epi & to clinic;tx w/ solu medrol;dx of anaphylactic rxn;			Y	Y	Y	1			Y	10/23/1995	10/23/1995	0		OTH	PVT		none		~ ()~~~In patient	895333022L	1						2	Anaphylactoid reaction; Dyspnoea; Pallor; Vasodilatation	FLU3~PFIZER\WYETH~4958110~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Life Threatening,Hospitalisation	Influenza
0080219	02/26/1996	NC	40.0	39		F	12/06/1995	pt recvd vax 3NOV95 & was adm to hosp 20NOV95 dx of a mild case of GBS;hospitalized 5 days & was discharged w/urinary catheter;114NOV devel flu-synd, aching of lower extremities;pt exp urinary retention;given ATB for UTI;					Y	2			Y	11/03/1995	11/14/1995	11	WBC 14,300; UA +nitrite, 105WBC/HPF, 2+ bacteria; urine culture neg; Hgb/Hct/SMA nl;	PVT	PVT	Zoloft	NONE	pt has had flu vax in the past;pt is status post: tubal ligation, hysterectomy, appendectomy;HTN & hx of depression	~ ()~~~In patient	895347005L	1						2	Guillain-Barre syndrome; Infection; Influenza; Leukocytosis; Myalgia; Urinary retention; Urinary tract infection; Urine analysis abnormal	FLU3~PFIZER\WYETH~4958079~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0080791	02/26/1996	GA	56.0	56		F	11/15/1995	pt recv vax & pt devel a rash (not itchy) & joint pain which cont at present									N	10/19/1995	10/28/1995	9		PVT	OTH	unk	unk		~ ()~~~In patient	895340019L	1						2	Arthralgia; Myalgia; Rash; Arthralgia; Oedema peripheral; Pain; Rash	FLU3~PFIZER\WYETH~4958136~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0080938	02/26/1996	ID				F	11/06/1995	pt recv vax 27OCT95 & exp red,macular generalized rash & inc urticaria;presented to ER & discharged p/given DPH;no resp compromise;returned to ER on 29OCT95 w/ c/o swollen tongue,wheezing & dyspnea;				Y					Y	10/27/1995	10/28/1995	1		PUB	PVT	unk	cold	pt exp urticaria and respiratory problems during latex patch test	~ ()~~~In patient	895336004L	1						2	Dyspnoea; Rash maculo-papular; Respiratory disorder; Tongue oedema; Urticaria; Asthma; Dyspnoea; Hypersensitivity; Rash maculo-papular; Tongue oedema; Urticaria	FLU3~PFIZER\WYETH~4958125~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4958125~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0081461	02/26/1996	CT	74.0	73		F	02/20/1996	pt recvd vax & devel weak feeling, canker sore, lips hurt, h/a;	Y	11/20/1995							N	11/16/1995	11/19/1995	3	NONE	PVT	PVT	NONE		sulfa allergy	NONE~ ()~~~In patient		1						2	Asthenia; Mouth ulceration; Asthenia; Headache; Mouth ulceration; Pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Results in Death	Influenza
0083045	02/26/1996	MS	46.0	46		F	11/20/1995	pt recvd vax 21SEP & devel rash on groin & stomach;22SEP MD changed meds pt awakened 23SEP w/h/a, swollen tongue, conjunctivitis, pt to ER pt near syncope			Y		Y					09/21/1995	09/22/1995	1	NONE	UNK	UNK	atarax, cardizem CD, premarin, maxzide		HTN	~ ()~~~In patient		1						1	Conjunctivitis; Headache; Rash; Syncope; Tongue oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0083047	02/26/1996	AR	71.0	71		F	02/07/1996	21NOV95 pt lt arm sore from flu shot;arm sore 4 or 5 days p/shot-no redness or swelling,but it hurts when move it;arm was stiff;local rxn p/flu vax;sneezing a lot,chest congestion & face swollen;limited motion of shoulder;tendonitis;				Y					Y	11/08/1995	11/13/1995	5	NO paresthesia;x-ray of the arm WNL;	PUB	PUB	Antihypertive meds-Capozide	NONE	NONE	~ ()~~~In patient	AR9611	1						1	Face oedema; Hypokinesia; Injection site mass; Injection site reaction; Lung disorder; Myalgia; Pain; Tendon disorder	FLU3~CONNAUGHT LABORATORIES~5F61119~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0083064	02/26/1996	NC	55.0	55		F	02/22/1996	31OCT95 AM had elevated temp, h/a & rt inj site swollen, red & could not move rt arm;PM 31OCT pt devel a rash from rt shoulder to rt elbow x 36hrs & h/a lasted 3 days;pt notified MD & tx w/bed rest & h/a rx;2wks later tx pneumonia									Y	10/30/1995	10/31/1995	1		PUB	PUB				~ ()~~~In patient	NC96017	1						1	Drug ineffective; Headache; Hypokinesia; Infection; Injection site hypersensitivity; Injection site oedema; Pneumonia; Pyrexia	FLU3~PARKE-DAVIS~01395P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~390934~UNK~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0083446	02/26/1996	NY	34.0	34		F	10/18/1995	pt recv vax;devel anaphylactic rxn approx 45 min p/ vax;sx included hives,swelling of tongue & diff breathing;tx at er w/ epi & adm to hosp;					Y				U	10/17/1995	10/17/1995	0		PVT	OTH		URI 1 wk prior to vax;		~ ()~~~In patient	895297016L	1						1	Anaphylactoid reaction; Dyspnoea; Headache; Tongue oedema; Urticaria	FLU3~PFIZER\WYETH~4958084~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0083448	02/26/1996	WI	18.0			F	12/14/1995	pt recv vax;to hosp w/ sx of encephalopathy;bacterial cultures neg;tx w/ acyclovir for viral encephalopathy;sx resolved other time;					Y	4			U	11/26/1995	12/10/1995	14	bacterial cultures neg;	OTH	OTH				~ ()~~~In patient	895353006L	1						1	Confusional state; Encephalopathy; Hypokinesia; Thinking abnormal	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0083913	02/26/1996	NJ				U	10/04/1995	pt recvd vax & c/o localized redness & swelling @ inj site;									U	10/03/1995	10/03/1995	0		PUB	OTH	unk	unk		~ ()~~~In patient	895285015L	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4958125~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083914	02/26/1996	NJ				U	10/04/1995	pt c/o localized redness & swelling @ inj site;									U	10/03/1995	10/03/1995	0		PUB	OTH	unk	unk		~ ()~~~In patient	895285016L	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4958125~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083915	02/26/1996	NJ				U	10/04/1995	pt recvd vax & c/o localized redness & swelling @ inj site;									U	10/03/1995	10/03/1995	0		PUB	OTH	unk	unk		~ ()~~~In patient	895285017L	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4958125~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083916	02/26/1996	NJ				U	10/04/1995	pt recvd vax & localized redness & swelling @ inj site									U	10/03/1995	10/03/1995	0		PUB	OTH	unk	unk		~ ()~~~In patient	895285018L	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4958125~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083917	02/26/1996	NJ				U	10/04/1995	pt recvd vax & c/o localized redness & swelling @ inj site									U	10/03/1995	10/03/1995	0		PUB	OTH	unk	unk		~ ()~~~In patient	895285019L	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4958125~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083918	02/26/1996	NJ				U	10/04/1995	pt recvd vax & c/o localized redness & swelling @ inj site;									U	10/03/1995	10/03/1995	0		PUB	OTH	unk	unk		~ ()~~~In patient	895285020L	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4958125~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083919	02/26/1996	TN	55.0	55		F	10/09/1995	pt recv vax 2OCT95 & 3OCT95 devel a hive-like rash on neck which progressed to a gen body rash;dermatologist dx rash as eczema;tx w/steroid cream;				Y					U	10/02/1995	10/03/1995	1		OTH	OTH	Plaquinil	sjogrens disease	pt has hx of sjogrens disease	~ ()~~~In patient	895293003L	1						1	Eczema; Rash; Urticaria	FLU3~PFIZER\WYETH~~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0083920	02/26/1996	IA				U	10/10/1995	pt devel a severe local rxn p/receiving flu vax;									U					PVT	PVT	unk	unk	unk	~ ()~~~In patient	895293005L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083921	02/26/1996	NV	66.0	66		M	10/10/1995	pt recv vax 6OCT95 & devel a tennis ball size swelling @ inj site which resolved p/several days;addtl info recv 7DEC95: pt devel $1.00 sized red welt following vax;									Y	10/05/1995	10/06/1995	1		PVT	PVT	unk	NONE	psorasis, osteoporosis	~ ()~~~In patient	895293006L	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4958067~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083922	02/26/1996	NY	32.0	32		F	10/06/1995	pt recv vax  1 1/2 wk ago;pt recently discovered is 4 wk pregnant,& has been experiencing cramping since receiving the vax & subsequent dx of pregnancy									U	09/01/1995				OTH	OTH	unk	unk		~ ()~~~In patient	895293007L	1						1	Abdominal pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083923	02/26/1996	OR	25.0	25		F	10/12/1995	pt recvd vax 10OCT95 & 11OCT95, pt devel an inj site rxn characterized by redness & swelling;no other details known as of the date of this report									Y	10/10/1995	10/11/1995	1		PVT	PVT	unk	unk		~ ()~~~In patient	895293009L	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~SC A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083924	02/26/1996	MD	70.0	70		F	10/10/1995	pt recvd vax 26SEP95 & on 28SEP95 devel edema @ the inj site;also an elevated temp & chills;pt was treated w/DPH & APAP & has recovered;									Y	09/26/1995	09/28/1995	2		PVT	OTH	unk	NONE		~ ()~~~In patient	895296001L	1						1	Chills; Injection site oedema; Pyrexia	FLU3~PFIZER\WYETH~4958113~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083925	02/26/1996	MD	21.0	21		F	10/10/1995	pt recvd vax 6OCT95 & immed devel a local rxn the size of a fifty cents piece;the rxn resolved by the following day;									Y	10/06/1995	10/06/1995	0		OTH	OTH	unk	NONE		~ ()~~~In patient	895296002L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~4958113~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083926	02/26/1996	MD				F	10/10/1995	pt recvd vax 10OCT95 & that day pt devel an inj site rxn which was characterized as warm & approx the circumference on an orange;rxn was treated w/ice & persisting as of the date of the report;									N	10/10/1995	10/10/1995	0		PVT	PUB	hydrochlorothiazide, norvasc	unk	HTN	~ ()~~~In patient	895296003L	1						1	Injection site reaction; Vasodilatation	FLU3~PFIZER\WYETH~4958113~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083927	02/26/1996	MI	51.0	51		F	10/12/1995	pt recvd vax 10OCT95 & that day pt exp h/a, fatigue & inj site redness (50mmx60mm);pt was afeb;pt recovered from the above rxn;				Y					Y	10/10/1995	10/12/1995	2		PUB	PVT	unk	NONE	NKA, hx of arthritis	~ ()~~~In patient	895296005L	1						1	Asthenia; Headache; Injection site hypersensitivity	FLU3~PFIZER\WYETH~4958078~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0083928	02/26/1996	LA				U	10/10/1995	pt recvd vax & exp itch, pain, swelling & inflammation @ inj site w/in 24hrs post vax; inflamed area was as large as a silver dollar coin;this is one of 11 patients who exp the above rxn p/vax									U	10/01/1995				PVT	OTH	unk	unk		~ ()~~~In patient	895296015L	1						1	Injection site inflammation; Injection site oedema; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~4958113~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083929	02/26/1996	LA				U	10/10/1995	pt recvd vax & an inj site rxn characterized by itch, pain, swelling & inflammation w/in 24hrs post inj;the inflamed area was as large as silver dollar coin;pt also exp chills & fever;									U	10/01/1995				PVT	OTH	unk	unk		~ ()~~~In patient	895296016L	1						1	Chills; Injection site inflammation; Injection site oedema; Injection site pain; Pruritus; Pyrexia	FLU3~PFIZER\WYETH~4958113~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083930	02/26/1996	WI	38.0			F	10/11/1995	pt recvd vax & devel an inj site rxn characterized by swelling, itching, erythema & warmth;									U					PVT	PVT	unk	unk	allergic to sulfa, iodine, shellfish	~ ()~~~In patient	895296017L	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4958078~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083931	02/26/1996	HI				U	10/06/1995	pt devel a fever & myalgia;these sx lasted a short time & resolved;this is one of 3 pts who exp above rxn;									Y					PVT	OTH	unk	unk		~ ()~~~In patient	895296018L	1						1	Myalgia; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083932	02/26/1996	MN				U	10/11/1995	pt recvd vax & devel a severe local rxn of redness @ inj site;pt also exp fevers and body aches;this is one of nine pts who exp above rxn;									U					OTH	OTH	unk	unk		~ ()~~~In patient	895297011L	1						1	Injection site hypersensitivity; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4958137~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083933	02/26/1996	MN	48.0	48		F	10/11/1995	pt recvd vax 6OCT95 & that same day pt devel an inj site rxn characterized by redness & inflammation the size of a fifty cent piece;rxn subsequently spread to elbow & lt arm became red & hot;pt was unable to bend joint;body aches;t102-3									U	10/06/1995	10/06/1995	0	NONE	PVT	OTH	Erythromycin;Estrase;Mantoux intradermal;codeine	NONE	allergies	~ ()~~~In patient	895297002L	1						1	Hypokinesia; Injection site hypersensitivity; Injection site inflammation; Myalgia; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4958137~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083934	02/26/1996	FL	55.0	54		F	10/09/1995	pt recvd vax 2OCT95 & devel pain, soreness & a 2 inch red area on arm;this is one of three pts from this site to report adverse reactions;pt is recovered;									Y	10/02/1995	10/03/1995	1		OTH	PVT	unk	unk		~ ()~~~In patient	895297003L	1						1	Myalgia; Pain; Vasodilatation; Myalgia; Oedema; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0151B~UNK~IM A~~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~0151B~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0083935	02/26/1996	MI				F	10/19/1995	pt recvd vax & devel an inj site rxn characterized by redness & inflammation approx 2 inches in size									U	10/17/1995	10/17/1995	0		OTH	OTH	unk	unk		~ ()~~~In patient	895299014L	1						1	Injection site hypersensitivity; Injection site inflammation	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083936	02/26/1996	IN				U	10/18/1995	pt exp an unspecified rxn p/flu vax;No further details known as of the date of this report									U					PVT	PVT		unk		~ ()~~~In patient	895299017L	1						1	Unevaluable event	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083937	02/26/1996	KS	48.0	48		F	10/18/1995	pt recvd vax 17OCT95 & 2-3mins p/vax pt devel an inj site rxn characterized by pain radiating from site to elbow & across back), redness;sx also included nausea & flushing;pt given DPH;									U	10/17/1995	10/17/1995	0		OTH	OTH	Armour thyroid, Effexor, estratest, Hismanal, Norvasc, Provera	NONE		~ ()~~~In patient	895300004L	1						1	Injection site hypersensitivity; Injection site pain; Nausea; Vasodilatation	FLU3~PFIZER\WYETH~~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083938	02/26/1996	OH				U	10/18/1995	1 of 5 patients who recv flu vax,& w/in 1 day of vax devel malaise,stiffness,fever & congestion;addtl info 27NOV95: 5 patients,all in same company dept,had viruses around the same time of vax & all sx were attributed to viral infect;									N	10/16/1995				PVT	OTH	unk	NONE		~ ()~~~In patient	895300005L	1						1	Hypertonia; Infection; Lung disorder; Malaise; Pyrexia; Rhinitis	FLU3~PFIZER\WYETH~4958108~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083939	02/26/1996	TX				F	10/17/1995	pt recvd vax 16OCT95 & 17OCT95 devel swelling in rt hand & wrist (arm in which recvd inj);pt rxn was tx w/APAP, ice & elevation;									U	10/16/1995	10/17/1995	1		PVT	PVT	unk	NONE		~ ()~~~In patient	895300006L	1						1	Oedema peripheral	FLU3~PFIZER\WYETH~4958119~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083940	02/26/1996	TX				F	10/19/1995	pt recvd vax 17OCT95 & that day devel an inj site rxn characterized by redness, warmth, swelling & hardness;the above rxn lasted for 1 day & subsided;this is one of three patients from this site who exp these sx p/flu vax									Y	10/17/1995	10/17/1995	0		OTH	PVT	unk	NONE		~ ()~~~In patient	895300010L	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4958119~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083941	02/26/1996	TX				F	10/19/1995	pt recvd vax 18OCT95 & devel an inj site rxn characterized by redness, warmth, swelling & hardness;the above rxn lasted for 1 day & subsided;this is one of three patients from this site who exp these sx p/flu vax;									Y	10/18/1995	10/18/1995	0		OTH	PVT	unk	NONE		~ ()~~~In patient	895300011L	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083942	02/26/1996	TX				F	10/19/1995	pt recvd vax 16OCT95 & devel inj site rxn characterized by redness, warmth, swelling & hardness;the above rxn lasted for 1 day and subsided;this is one of the three patients from this site who exp this rxn									Y	10/16/1995	10/16/1995	0		OTH	PVT	unk	NONE		~ ()~~~In patient	895300012L	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083943	02/26/1996	VT				F	10/20/1995	pt recv vax 17OCT95 & 18OCT95 devel a diffuse rash characterized as red,punctate & w/a halo around it;pt was tx w/DPH;addtl info recv 30NOV95: pt was dx w/pseudomonas rash									U	10/17/1995	10/18/1995	1		PVT	PVT	NONE	NONE		~ ()~~~In patient	895304005L	1						1	Rash	FLU3~PFIZER\WYETH~4958138~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083944	02/26/1996	MA	53.0	53		F	10/16/1995	pt recv vax 11OCT95 & 12OCT95 pt devel achiness & fever followed by diarrhea & mucousy foul-smelling stools;pt further c/o nausea;pt recovered from above sx									Y	10/11/1995	10/12/1995	1		OTH	OTH	cyclosporin;pred	unk	post heart transplant-1988	~ ()~~~In patient	895304014L	1						1	Diarrhoea; Myalgia; Nausea; Pyrexia	FLU3~PFIZER\WYETH~~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083945	02/26/1996	LA				U	10/10/1995	pt recvd vax & exp itch, pain, swelling & inflammation @ inj site w/in 24hrs post vax;the inflamed area was as large as a silver dollar coin;this is one of 11 patients who exp the above rxn p/receiving the above lot number									U	10/01/1995				PVT	OTH	unk	unk		~ ()~~~In patient	895307003L	1						1	Injection site inflammation; Injection site oedema; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~4958113~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083946	02/26/1996	LA				U	10/10/1995	pt recvd vax & exp itch, pain, swelling & inflammation @ inj site w/in 24hrs post vax;the inflamed area was as large as a silver dollar coin;this is one of 11 patients who exp the above rxn p/receiving the above lot number									U	10/01/1995				PVT	OTH	unk	unk		~ ()~~~In patient	895307004L	1						1	Injection site inflammation; Injection site oedema; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~4958113~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083947	02/26/1996	LA				U	10/10/1995	pt recvd vax & exp itch, pain, swelling & inflammation @ inj site w/in 24hrs post vax;the inflamed area was as large as a silver dollar coin;this is one of 11 patients who exp the above rxn p/the above lot number;									U	10/01/1995				PVT	OTH	unk	unk		~ ()~~~In patient	895307005L	1						1	Injection site inflammation; Injection site oedema; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~4958113~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083974	02/26/1996	LA				U	10/10/1995	pt recv vax;exp itch,pain,swelling & inflammation at inject site w/in 24 hrs;inflamed area was as large as a silver dollar coin;this is one of 11 patients who exp the above rxn p/vax									U					PVT	OTH				~ ()~~~In patient	895307006L	1						1	Injection site inflammation; Injection site oedema; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~4958113~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083975	02/26/1996	LA				U	10/10/1995	pt recv vax;exp itch,pain,swelling & inflam at inject site w/in 24 hrs post inject;inflamed area as large as silver coin;this is one of 11 patients who exp the above rxn p/the vax									U					PVT	OTH				~ ()~~~In patient	895307007L	1						1	Injection site inflammation; Injection site oedema; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~4958113~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083976	02/26/1996	LA				U	10/10/1995	pt recv vax;exp itch,pain,swelling & inflammation at inject site;inflamed area as large as a silver dollar coin;this is one of 11 patients who exp the above rxn p/vax									U					PVT	OTH				~ ()~~~In patient	895307008L	1						1	Injection site inflammation; Injection site oedema; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~4958113~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083977	02/26/1996	LA				U	10/10/1995	pt recv vax;exp itch,pain,swelling & inflammation at inject site;inflamed area was as large as a silver dollar coin;This is one of 11 patients who exp the above rxn p/vax									U					PVT	OTH				~ ()~~~In patient	895307009L	1						1	Injection site inflammation; Injection site oedema; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~4958113~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083978	02/26/1996	LA				U	10/10/1995	pt recv vax;exp itch,swelling & inflammation at inject site;inflamed area as large as dollar coin;this is one of 11 patients who exp the above rxn p/vax									U					PVT	OTH				~ ()~~~In patient	895307010L	1						1	Injection site inflammation; Injection site oedema; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~4958113~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083979	02/26/1996	LA				U	10/10/1995	pt recv vax;exp itch,pain,swelling & inflam at inject site;inflamed area as large as dollar coin;this is one of 11 patients who exp the above rxn p/vax									U					PVT	OTH				~ ()~~~In patient	895307011L	1						1	Injection site inflammation; Injection site oedema; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~4958113~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083980	02/26/1996	LA				U	10/10/1995	pt recv vax;exp itch,pain,swelling & inflamed at inject site w/in 24hrs post vax;the inflamed area was as large as silver dollar coin;this is one of 11 patients who exp the above rxn p/vax									U					PVT	OTH				~ ()~~~In patient	895307012L	1						1	Injection site inflammation; Injection site oedema; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~4958113~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083981	02/26/1996	WI	40.0			F	10/11/1995	pt recvd vax; devel inject site rxn characterized by swelling, itching, erythema, warmth;									U					PVT	PVT	Traiphasil	NONE	NKA	~ ()~~~In patient	895307013L	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4958078~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083982	02/26/1996	WI	36.0	36		F	10/11/1995	pt recvd vax; devel inject site rxn characterized by swelling,itching,erythema,warmth;									U	10/06/1995	10/06/1995	0		PVT	PVT		NONE	NKDA	~ ()~~~In patient	895307014L	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4958078~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083983	02/26/1996	WI	33.0			F	10/11/1995	pt recvd vax; devel inject site rxn characterized by swelling, itching,erythema, warmth									U					PVT	PVT		NONE	NKDA;	~ ()~~~In patient	895307015L	1						1	Injection site hypersensitivity; Injection site oedema; Neck pain; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4958078~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083984	02/26/1996	HI				U	10/06/1995	pt recvd vax; devel fever & myalgia; sx lasted short time & resolved;									Y					PVT	OTH				~ ()~~~In patient	895307016L	1						1	Myalgia; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083985	02/26/1996	HI				U	10/06/1995	pt recvd vax; devel fever & myalgia;sx lasted short time & resolved;									Y					PVT	OTH				~ ()~~~In patient	895307017L	1						1	Myalgia; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083986	02/26/1996	MN				U	10/11/1995	pt recvd vax; devel severe local rxn & redness at inject site; exp fevers & body aches;									U					OTH	OTH				~ ()~~~In patient	895307022L	1						1	Injection site hypersensitivity; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4958137~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083987	02/26/1996	MN				U	10/11/1995	pt recvd vax; devel severe local rxn & redness at inject site; also exp fevers & body aches;									U					OTH	OTH				~ ()~~~In patient	895307023L	1						1	Injection site hypersensitivity; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4958137~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083988	02/26/1996	MN				U	10/11/1995	pt recvd vax; devel severe local rxn & redness at inject site; exp fevers & body aches;									U					OTH	OTH				~ ()~~~In patient	895307024L	1						1	Injection site hypersensitivity; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4958137~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083989	02/26/1996	MN				U	10/11/1995	pt recvd vax; devel severe local rxn & redness at inject site; also exp fever & body aches									U					OTH	OTH				~ ()~~~In patient	895307025L	1						1	Injection site hypersensitivity; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4958137~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083990	02/26/1996	MN				U	10/11/1995	pt recvd vax; devel severe local rxn of redness at inject site; also exp fevers & body aches;									U					OTH	OTH				~ ()~~~In patient	895307026L	1						1	Injection site hypersensitivity; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4958137~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083991	02/26/1996	MN				U	10/11/1995	pt recvd vax; devel severe local rxn of redness at inject site; also exp fevers & body aches;									U					OTH	OTH				~ ()~~~In patient	895307027L	1						1	Injection site hypersensitivity; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4958137~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083992	02/26/1996	MN				U	10/11/1995	pt recvd vax; devel severe local rxn of redness at inject site; also exp fevers & aches;									U					OTH	OTH				~ ()~~~In patient	895307028L	1						1	Injection site hypersensitivity; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4958137~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083993	02/26/1996	MN				U	10/11/1995	pt recvd vax; devel severe local rxn of redness at inject site; also exp fevers & body aches;									U					OTH	OTH				~ ()~~~In patient	895307029L	1						1	Injection site hypersensitivity; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4958137~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083994	02/26/1996	FL	42.0	42		F	10/09/1995	pt recvd vax; inject arm became swollen to twice its nl size, red & painful; pt reported intermittent sweating;									Y	10/06/1995	10/06/1995	0		OTH	PVT				~ ()~~~In patient	895307031L	1						1	Hyperhidrosis; Oedema peripheral; Pain; Vasodilatation; Chills; Hyperhidrosis; Injection site pain; Malaise; Myalgia; Oedema; Vasodilatation	FLU3~PFIZER\WYETH~4958089~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0151B~UNK~IM~~PNEUMO (PNEUMOVAX)~1|FLU3~PFIZER\WYETH~4958089~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~MERCK & CO. INC.~0151B~UNK~~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0083995	02/26/1996	FL	63.0	63		F	10/09/1995	pt recvd vax; devel inject site rxn characterized by red hot swollen and itchy area from inject site to the elbow;									Y	10/05/1995	10/05/1995	0		OTH	PVT				~ ()~~~In patient	895307032L	1						1	Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4958089~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083996	02/26/1996	MN	32.0	32		F	10/31/1995	pt recvd vax; devel non raised rash on chest, which spread to the trunk;									Y	10/25/1995	10/27/1995	2		PVT	OTH	synthroid, claritin	none	hx of various food allergies;poss allergy to yellow & red dyes; also had hyperthyroidism;	~ ()~~~In patient	895312008L	1						1	Rash	FLU3~PFIZER\WYETH~4958151~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083997	02/26/1996	OH	59.0	59		F	10/23/1995	pt recvd vax; devel HA, sneezing & runny nose;									Y	10/18/1995	10/20/1995	2		PVT	OTH				~ ()~~~In patient	895313003L	1						1	Headache; Rhinitis	FLU3~PFIZER\WYETH~4958110~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083998	02/26/1996	OH	48.0	48		F	10/17/1995	pt recvd vax;by following day, devel large reddened area at inject site;									U	10/16/1995	10/17/1995	1		PVT	OTH		none		~ ()~~~In patient	895313004L	1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~4958110~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083999	02/26/1996	OH	49.0	49		F	10/16/1995	pt recvd vax; devel inject site rxn characterized by pain & induration;c/o neck pain & stiffness;									U	10/16/1995	10/16/1995	0		PUB	OTH		none		~ ()~~~In patient	895313005L	1						1	Injection site mass; Injection site pain; Neck pain; Nuchal rigidity	FLU3~PFIZER\WYETH~4958110~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084000	02/26/1996	CT	27.0	27		F	10/27/1995	pt recvd vax; devel local rxn & bad joint pain which progressively worsened over 3 days;CBC nl; SGOT elev & pt also had elev BUN/creatinine ratio; arthralgias resolved p/ several days;				Y					Y	10/24/1995	10/24/1995	0	SGOT elev; BUN/creatinine ratio elev; ANA pos 1:320 homogeneous speckled;	PUB	PUB	PPD im	none	pollens from glove powder or latex;	~ ()~~~In patient	895313006L	1						1	Arthralgia; Aspartate aminotransferase increased; Blood creatinine increased; Blood urea increased; Injection site reaction; Laboratory test abnormal	FLU3~PFIZER\WYETH~4958113~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084001	02/26/1996	WY	53.0			F	10/26/1995	pt recvd vax 23OCT95 & devel erythema approx 2cm below the inj site (14cm x 13cm in diameter);pt has not yet recovered as of 26OCT95;				Y					N	10/23/1995	10/24/1995	1		OTH	OTH	unk	unk		~ ()~~~In patient	895313008L	1						1	Rash	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TTOX~PFIZER\WYETH~~UNK~~RA~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0084002	02/26/1996	PA	48.0	48		F	10/27/1995	pt recvd vax 25OCT95 & 26OCT c/o swollen lymph glands w/tenderness in lt axilla;flu vax given in lt arm;no further details known as the date of this report;									U	10/25/1995	10/26/1995	1		OTH	OTH	NONE	NONE		~ ()~~~In patient	895313011L	1						1	Lymphadenopathy; Myalgia	FLU3~PFIZER\WYETH~4958090~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084003	02/26/1996	WA				U	10/27/1995	pt recvd vax 23OCT95 & pt devel a severe inj site rxn characterized by pain & inflammation;pt has recovered;this is one of six patients from this site who exp the above reaction									Y	10/23/1995				PVT	PVT	unk	unk	unk	~ ()~~~In patient	895313012L	1						1	Injection site inflammation; Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084004	02/26/1996	MD	46.0	46		F		pt recv vax 24OCT95 & devel a feeling that lips were swollen (paresthesia w/pins & needles);pt's blood pressure was also elevated to 160/100;pt does have a hx of labile hypertension;upon exam by MD there was no visible swelling of lips;				Y					Y	10/24/1995	10/27/1995	3		PVT	OTH	NONE	NONE	labile HTN	~ ()~~~In patient	895313015L	1						1	Condition aggravated; Face oedema; Hypertension; Paraesthesia oral	FLU3~PFIZER\WYETH~4958076~4~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084005	02/26/1996	VA	48.0	48		F	11/03/1995	pt recv vax 25OCT95 & 27OCT95 devel a h/a;by 30OCT95 had a severe h/a & nausea;pt underwent a CT scan & consultation by a neurologist;ct scan was read as neg;sx cont to worsen pt devel nucal rigidity;dx meningitis				Y					Y	10/25/1995	10/27/1995	2	CT scan neg; LP neg; WBC 583; monos 11; lymphs 89;cultures no growth;T protein 128;	MIL	MIL	NONE	NONE	reporter notes that there have been several isolated cases of aseptic meningitis reported in the community	~ ()~~~In patient	895313019L	1						1	CSF test abnormal; Headache; Infection; Meningitis; Nausea; Nuchal rigidity	FLU3~PFIZER\WYETH~4958080~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084006	02/26/1996	MI	62.0	62		M	10/25/1995	pt recvd vax 4OCT95 & 5OCT95 pt devel tinnitus & hearing loss in the lt ear;no further details known as of the date of this report;									U	10/04/1995	10/05/1995	1		OTH	OTH	Ecotrin, Glucotrol, Multivit, Norvasc, pred, Xanax, Zestril	unk		~ ()~~~In patient	895313020L	1						1	Deafness; Tinnitus	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084007	02/26/1996	MI				U	10/26/1995	pt recvd vax & w/in 5 mins of inj pt devel dizziness, weakness, sweats & fatigue;this is one of four patients who exp above reaction at this site									U	10/23/1995	10/23/1995	0		PVT	PVT	unk	unk		~ ()~~~In patient	895313022L	1						1	Asthenia; Dizziness; Hyperhidrosis	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084008	02/26/1996	TX	62.0	62		F	10/25/1995	pt recvd vax 7OCT95 & 21OCT95 pt devel a rash on the lt leg;no further details known as of the date of this report;									U	10/07/1995	10/21/1995	14		OTH	OTH	unk	NONE		~ ()~~~In patient	895313023L	1						1	Rash	FLU3~PFIZER\WYETH~4958132~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084009	02/26/1996	RI	29.0	29		F	10/25/1995	pt devel an inj site rxn characterized as red, raised, painful & warm area around site, day p/vax;this is one of three patients from this site who exp the above reaction coincident w/the use of lot number 4958068;									U	10/23/1995	10/24/1995	1		PVT	PVT	NONE	NONE		~ ()~~~In patient	895313024L	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4958068~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084010	02/26/1996	RI	62.0	62		F	10/25/1995	pt recvd vax & devel inj site rxn characterized as red, raised, painful & warm area around the site, the day p/flu vax;this is one of three patients from this site who exp the above reaction coincident w/the use of lot number 4958068									U	10/23/1995	10/24/1995	1		PVT	PVT	NONE	NONE		~ ()~~~In patient	895313026L	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4958068~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084011	02/26/1996	RI	28.0	28		F	10/25/1995	pt devel an inj site rxn characterized as red, raised, painful & warm area around the site, the day p/vax;this is one of three patients from this site who exp the above rxn coincident w/the use of lot# 4958068									U	10/23/1995	10/24/1995	1		PVT	PVT	NONE	NONE		~ ()~~~In patient	895313027L	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4958068~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084012	02/26/1996	TN	71.0	71		M	10/20/1995	pt recvd flu vax 11OCT95 & devel an inj site rxn characterized by redness, warmth & swelling, which extended to the elbow;pt was treated w/DPH & APAP									U	10/11/1995	10/12/1995	1	NONE	PVT	PVT	ASA, Centrum, Cephalexin, Valium, Vitamin, Zestril	diverticulitis	heart disease, HTN, RBBB, coronary bypass, gastroesophogeal reflux, osteoarthritis, diverticulitis, allergies-iodine, demerol, PNC, bactrim, cipro;	~ ()~~~In patient	895313028L	1						1	Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Vasodilatation	FLU3~PFIZER\WYETH~4958124~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0084013	02/26/1996	TN	71.0	71		F	10/20/1995	pt recvd vax 11OCT95 & by 12OCT95 pt had devel a rash around the inj site & itching @ both palms, above the lt knee & the rt elbow;the pt has recovered;									Y	10/11/1995	10/12/1995	1	NONE	PVT	PVT	Calcium, corgard, dyazide, extra strength APAP, occupress eye drops, pred, reglan, stresstabs, tagamet	unk	HTN,lumbar spondylosis, gastroesopageal reflux, menopausal synd, dysequilibrium, chronic sinusitis, allergy codeine;	~ ()~~~In patient	895313030L	1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~4958124~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0084014	02/26/1996	TN				M	10/20/1995	pt recvd vax OCT95 & the following day devel an inj site rash characterized by raised itchy bumps;this rxn resolved w/o treatment by the third day post vax;									Y	10/01/1995	10/01/1995	0	NONE	PVT	PVT	unk	unk	springtime inhalants, HTN, CA prostate;	~ ()~~~In patient	895313031L	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Rash	FLU3~PFIZER\WYETH~4958124~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084015	02/26/1996	HI				U	10/06/1995	pt recv vax & devel severe aches & fever for several days;hx included rheumatoid arthritis;pt eventually recovered & also recv addtl med for arthritic flares;this is one of 3 patients from this site who exp above rxn p/lot# 4958106									Y					OTH	OTH	unk	unk	rheumatoid arthritis	~ ()~~~In patient	895313032L	1						1	Arthritis; Condition aggravated; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4958106~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084016	02/26/1996	WI	57.0	57		F	11/03/1995	pt recv vax 26OCT95 220PM & by 430PM pt began to devel chest tightness & pressure like in a vice;pt felt unable to catch breath;had sx of shakiness,profuse diaphoresis,pallor,vertigo & nausea;felt lightheaded & shaky;									U	10/27/1995	10/27/1995	0		OTH	OTH	unk	NONE	allergic to sulfa (devel a rash);recvd various flu shots in pas w/o problems;	~ ()~~~In patient	895317003L	1						1	Chest pain; Dizziness; Dyspnoea; Hyperhidrosis; Nausea; Pallor; Tremor; Vertigo	FLU3~PFIZER\WYETH~4958101~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084017	02/26/1996	OK	38.0	38		F	11/07/1995	pt recv vax 29OCT95 & devel muscle weakness,fatigue & gen itching;pt has not yet recovered as of reporting date				Y					N	10/29/1995	10/29/1995	0		PVT	PVT	unk	unk		~ ()~~~In patient	895317044L	1						1	Asthenia; Myasthenic syndrome; Pruritus	FLU3~PFIZER\WYETH~4958071~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084018	02/26/1996	TX	59.0	58		F	11/07/1995	pt recv vax;devel muscle weakness,itching,face edema,edema of extremities,muscle soreness & itching on stomach;				Y					N	10/29/1995	10/30/1995	1		PVT	PVT	premarin, provera, motrin			~ ()~~~In patient	895317005L	1						1	Face oedema; Myalgia; Myasthenic syndrome; Oedema peripheral; Pruritus	FLU3~PFIZER\WYETH~4958071~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084019	02/26/1996	OR				U	10/20/1995	pt recvd vax; devel soreness at inject site lasting 2 days;									U					OTH	OTH				~ ()~~~In patient	895317008L	1						1	Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084020	02/26/1996	NJ				U	10/18/1995	pt recvd vax; devel inject site rxn characterized by redness & hardness;									Y	10/17/1995	10/17/1995	0		PVT	PVT				~ ()~~~In patient	895317011L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4958076~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084021	02/26/1996	NC	41.0	41		F	11/02/1995	pt recvd vax; devel inject site rxn characterized by warmth & redness;				Y					N	10/31/1995	11/02/1995	2		OTH	OTH				~ ()~~~In patient	895318004L	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PFIZER\WYETH~4958133~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084022	02/26/1996	MA				U	11/03/1995	pt recvd vax; devel inject site rxn characterized by induration & erythema; also exp malaise & n;									U	11/01/1995	11/02/1995	1		OTH	OTH				~ ()~~~In patient	895318005L	1						1	Injection site hypersensitivity; Injection site mass; Malaise; Nausea	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084023	02/26/1996	TX				U	11/03/1995	pt recv vax;devel flu like sx characterized by fever,malaise,deep body/muscle aches,HA & n;				Y					U					PUB	PUB				~ ()~~~In patient	895318006L	1						1	Headache; Influenza; Malaise; Myalgia; Nausea; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084024	02/26/1996	CA				U	11/01/1995	pt recvd vax; devel vertigo;									U					OTH	OTH				~ ()~~~In patient	895318007L	1						1	Vertigo	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084025	02/26/1996	CA				U	11/01/1995	pt recvd vax; devel vertigo;									U					OTH	OTH				~ ()~~~In patient	895318008L	1						1	Vertigo	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084026	02/26/1996	CA				U	11/01/1995	pt recvd vax; devel a hematoma at inject site;									U					OTH	OTH				~ ()~~~In patient	895318009L	1						1	Haemorrhage	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084027	02/26/1996	CA				U	11/01/1995	pt recvd vax; devel a hematoma at inject site;									U					OTH	OTH				~ ()~~~In patient	895318010L	1						1	Haemorrhage	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084086	02/26/1996	CA				U	11/01/1995	pt recv vax;devel inject site rxn characterized by induration & soreness in addition to a systemic rxn of chills & fever;									U					OTH	OTH				~ ()~~~In patient	895318011L	1						1	Chills; Injection site mass; Injection site pain; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084087	02/26/1996	MN	46.0	46		F	11/01/1995	pt recv vax;following day devel inject site rxn characterized by pain & induration 4-5cm in size;									U	10/30/1995	10/31/1995	1	NONE	OTH	OTH		cold, afeb	allergies to hismanal;	~ ()~~~In patient	895318016L	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~PFIZER\WYETH~4958074~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084088	02/26/1996	KY	47.0	47		F	11/02/1995	pt recv vax;devel sl amount of itching at inject site prior to inject then devel flu like sx of mild fever & gen aching;				Y					U	10/21/1995	10/21/1995	0		PVT	PVT				~ ()~~~In patient	895318017L	1						1	Influenza; Myalgia; Pruritus; Pyrexia	FLU3~PFIZER\WYETH~495124~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0084089	02/26/1996	MO				F	11/02/1995	pt recv vax;devel an inject site rxn characterized by soreness,redness & irritation;									Y	10/25/1995	10/26/1995	1		OTH	OTH	none	none	none	~ ()~~~In patient	895318019L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4958140~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084090	02/26/1996	IL	59.0	59		F	11/02/1995	pt recv vax;devel gen macular rash;also devel pruritus on noc of vax;									N	10/28/1995	10/28/1995	0	none	OTH	PVT	premarin	none	streptomycin allergy	~ ()~~~In patient	895318020L	1						1	Pruritus; Rash maculo-papular	FLU3~PFIZER\WYETH~4958132~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084091	02/26/1996	PA				F	11/01/1995	pt recv vax;devel sx of sore throat,bronchitis & fatigue;				Y					Y	10/26/1995				OTH	OTH				~ ()~~~In patient	895318021L	1						1	Asthenia; Bronchitis; Pharyngitis	FLU3~PFIZER\WYETH~4958068~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084094	02/26/1996	MN				U	11/02/1995	pt recv vax;devel hives & itching p/ vax;				Y					N					PVT	PVT				~ ()~~~In patient	895318027L	1						1	Pruritus; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084095	02/26/1996	CO	24.0	24		F	11/02/1995	pt recv vax;devel allergic rxn characterized by hives,wheezing and swelling of tongue p/ vax;tx w/ dph & sx resolved;									Y	10/30/1995	10/30/1995	0		PVT	PVT	PPD; PO contraceptives;	none		~ ()~~~In patient	895318029L	1						1	Asthma; Hypersensitivity; Tongue oedema; Urticaria; Asthma; Dyspnoea; Tongue oedema; Urticaria	FLU3~PFIZER\WYETH~9458140~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~SMITHKLINE BEECHAM~1725A4~1~IM~RA~HEP B (ENGERIX-B)~1|FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEP~SMITHKLINE BEECHAM~1725A4~1~IM~RA~HEP B (ENGERIX-B)~2	USA		Influenza
0084096	02/26/1996	KS	54.0	54		F	11/01/1995	pt recv vax;began to exp pain in inject arm;inject site characterized by erythema & warmth;									Y	10/30/1995	11/01/1995	2		OTH	PVT	premarin	none	na	~ ()~~~In patient	895319001L	1						1	Injection site hypersensitivity; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4958133~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084097	02/26/1996	MN				M	10/18/1995	pt recv vax;following day,had difficulty moving inject arm secondary to pain;had bump at site;no neurologic abnormalities;pt was evaluated & possibly felt he had inject site rxn;				Y					U	10/16/1995	10/17/1995	1		OTH	OTH				~ ()~~~In patient	895319002L	1						1	Hypokinesia; Injection site hypersensitivity; Injection site reaction; Pain	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084098	02/26/1996	IA	44.0			F	10/24/1995	pt recv vax;devel rash on underside of arm which lasted for 1.5 wk;rash reappeared on both lower legs which resolved in 4 days;									Y					PVT	PVT				~ ()~~~In patient	895319003L	1						1	Rash	FLU3~PFIZER\WYETH~4958085~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084099	02/26/1996	OR	47.0	47		F	10/18/1995	pt recv vax;devel soreness in injected arm;									U	10/16/1995	10/17/1995	1		OTH	OTH				~ ()~~~In patient	895319004L	1						1	Myalgia	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084100	02/26/1996	OK				U	10/13/1995	pt recv vax;devel inject site rxn characterized by pain,warmth,swelling & redness;									U	10/11/1995	10/12/1995	1		PVT	OTH		unk		~ ()~~~In patient	895319006L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4958119~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084101	02/26/1996	CO	32.0	31		M	10/25/1995	pt recv flu vax,was given inadvertently instead of TB test;devel redness on forearm at inject site which became progressively worse;addl info recv:pt reported swelling & redness lasted 4-5 days;									Y	10/25/1995	10/25/1995	0		PVT	PVT	TB tine test	none		~ ()~~~In patient	895319007L	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084102	02/26/1996	MN	39.0	39		F	11/14/1995	pt recv vax;devel local swelling & erythema at inject site;devel allergic rxn characterized by swelling of lips,shaking,hives on neck & head,and tachycardia;tx w/ dph & IV solu medrol;				Y					Y	11/09/1995	11/09/1995	0		PVT	PUB		none	severe sulfa allergy	~ ()~~~In patient	895321001L	1						1	Face oedema; Hypersensitivity; Injection site hypersensitivity; Injection site oedema; Tachycardia; Tremor; Urticaria	FLU3~PFIZER\WYETH~4958198~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084103	02/26/1996	PA	71.0	71		M	10/24/1995	pt recv vax;16oct95 devel sudden,substantial hearing loss;									U	10/13/1995	10/16/1995	3	NONE	PUB	OTH	procardia;slo-bid	emphysema	emphysema, HTN	~ ()~~~In patient	895325001L	1						1	Deafness	FLU3~PFIZER\WYETH~4958116~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084104	02/26/1996	PA				U	10/19/1995	pt recv vax;c/o d & feeling sick for approx a week;md did not feel sx were related to vax;									U					PVT	PVT				~ ()~~~In patient	895325002L	1						1	Diarrhoea; Malaise	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084105	02/26/1996	MD	81.0	81		M	11/09/1995	pt recv vax;approx 5 days later devel maculopapular rash on trunk & extremities;was given solumedrol & is currently on pred;				Y					Y	10/27/1995	10/28/1995	1		PVT	PVT	inderal, nitropatch, nitrostat, procardia	none	high blood pressure, coronary artery disease w/ angina;	~ ()~~~In patient	895325007L	1						1	Rash maculo-papular	FLU3~PFIZER\WYETH~4958109~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084106	02/26/1996	OH	46.0	46		F	10/23/1995	pt recv vax;c/o tongue feeling funny,face feeling warm,shaking of rt hand & uncomfortable feeling in rt leg;c/o dizziness;BP was nl;									U	10/23/1995	10/23/1995	0		PUB	OTH		none		~ ()~~~In patient	895326001L	1						1	Dizziness; Paraesthesia; Tongue disorder; Tremor; Vasodilatation	FLU3~PFIZER\WYETH~4958150~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084107	02/26/1996	CA				M	10/19/1995	pt recv vax 18OCT95 & by 19OCT95 230AM pt presented to ER w/a high fever,h/a & generalized maculopapular rash;no further details known as of the date of this report				Y					U	10/18/1995	10/19/1995	1		UNK	UNK	unk	unk			895326002L	1						1	Headache; Pyrexia; Rash maculo-papular	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084108	02/26/1996	ID				U	10/23/1995	pt recv vax & devel local soreness 1-1 & 1/2 days p/vax;2-3 days p/receiving flu pt broke out in hives;pt has recovered;									Y					PVT	PVT	unk	unk		~ ()~~~In patient	895326003L	1						1	Injection site pain; Urticaria	FLU3~PFIZER\WYETH~4958106~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084109	02/26/1996	ID				U	10/23/1995	pt recv vax & devel an inj site rxn characterized by redness & soreness,day p/vax given;pt has recovered;									Y					PVT	PVT	unk	unk		~ ()~~~In patient	895326004L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4958106~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084110	02/26/1996	PA	43.0	43		M	10/24/1995	pt recv flu vax 23OCT95 & that day,pt exp atropine-like sx & a dry mouth;No further details known as of the date of this report;									Y	10/23/1995	10/24/1995	1		PVT	PVT	unk	none	none	~ ()~~~In patient	895326005L	1						1	Anticholinergic syndrome; Dry mouth	FLU3~PFIZER\WYETH~4958079~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084111	02/26/1996	OH				U	10/30/1995	pt recv vax & devel an inj site rxn;No further details known as of the date of this report;This is one of three patients from this site who exp above rxn;									U	10/01/1995	10/01/1995	0		OTH	OTH	unk	unk		~ ()~~~In patient	895326006L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084112	02/26/1996	TX				U	10/31/1995	pt recv vax & devel local rxn in addition to a systemic rxn of fever & malaise;									U					OTH	OTH	unk	unk		pt has had unspecified rxn, in prev yrs, to flu vax;each yr rxns have worsened;~ ()~~~In patient	895326007L	1						1	Injection site reaction; Malaise; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084113	02/26/1996	MI				U	10/26/1995	pt recv vax & w/in 5mins of inj,pt devel dizziness,weakness,sweats,& fatigue;This is one of 4 patients who exp above rxn @ this site;									U	10/23/1995	10/23/1995	0		PVT	PVT	unk	unk		~ ()~~~In patient	895326009L	1						1	Asthenia; Dizziness; Hyperhidrosis	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084114	02/26/1996	MI				U	10/26/1995	pt recv vax & w/in 5mins of inj pt devel dizziness,weakness,sweats,& fatigue;this is one of four patients who exp above rxn @ this site;									U	10/23/1995	10/23/1995	0		PVT	PVT	unk	unk		~ ()~~~In patient	895326010L	1						1	Asthenia; Dizziness; Hyperhidrosis	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084115	02/26/1996	MI				U	10/26/1995	pt recv vax & w/in 5mins of inj,pt devel dizziness,weakness,sweats,& fatigue;this is one of four patients who exp above rxn @ this site;									U	10/23/1995	10/23/1995	0		PVT	PVT	unk	unk		~ ()~~~In patient	895326011L	1						1	Asthenia; Dizziness; Hyperhidrosis	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084116	02/26/1996	HI				U	10/06/1995	pt recv vax & devel severe aches & fever for several days;hx included rheumatoid arthritis;pt eventually recovered & also recv addtl med for arthritic flares;this is one of 3 pts from this site who exp above rxn,p/lot# 4958106									Y					OTH	OTH	unk	unk		~ ()~~~In patient	895326012L	1						1	Arthralgia; Arthritis; Condition aggravated; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4958106~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084117	02/26/1996	HI				U	10/06/1995	pt recv vax & devel severe aches & fever for several days;hx included rheumatoid arthritis;pt eventually recovered & also recv addtl med for arthritic flares;this is one of 3 patients from this site who exp above rxn,p/vax									Y					OTH	OTH	unk	unk	rheumatoid arthritis	~ ()~~~In patient	895326013L	1						1	Arthralgia; Arthritis; Condition aggravated; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4958106~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084118	02/26/1996	KY				U	10/31/1995	pt recv vax & devel diffuse,itchy hives,in addition to an itchy & swollen throat;this is one of two patient from this site who exp the above rxn;									U					OTH	OTH	unk	unk		~ ()~~~In patient	895326014L	1						1	Laryngospasm; Pruritus; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084119	02/26/1996	TX	51.0	51		F	11/01/1995	pt recv vax 25OCT95 on 30OCT95 pt devel lymphadenopathy (one large node in lt clavicular area);pt's MD reportedly wanted to biopsy the node;pt felt it was getting smaller in size & softer than when it first appeared;				Y					U	10/25/1995	10/30/1995	5		OTH	OTH	unk	unk	breast cancer, bilat mastectomy 15 yrs ago	~ ()~~~In patient	895326015L	1						1	Lymphadenopathy	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084120	02/26/1996	WA				U	10/23/1995	pt recv vax & devel an inj site rxn characterized by impressive redness & soreness;pt also had a lot of arm pain;rxn has lasted 5-7days;this is one of 3pts from this sit who exp above rxn;									U					OTH	OTH	unk	unk		~ ()~~~In patient	895326018L	1						1	Injection site hypersensitivity; Injection site pain; Pain	FLU3~PFIZER\WYETH~4958119~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084121	02/26/1996	MO				U	11/02/1995	pt recv vax & c/o an inj site rxn characterized by redness,soreness,& irritation;No further details known as of reporting date;									U					OTH	OTH	unk	unk		~ ()~~~In patient	895331003L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4958140~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084122	02/26/1996	CT				U	11/08/1995	pt recv vax & devel inj site rxn;no further details known as of the date of this report;									U					OTH	OTH	unk	unk		~ ()~~~In patient	895331005L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084123	02/26/1996	OH	58.0	58		F	11/10/1995	pt recv vax & 24hrs later exp shoulder to finger pain;pain lasted 1month;pt was treated w/flexeril & darvocet N-100;pt has had several flare-ups,lasting about 1wk,since then reported noted that inj may have been given higher up in arm				Y					N	10/20/1995	10/21/1995	1		PUB	PUB	Triamterene/HCL	NONE	HTN	~ ()~~~In patient	895331025L	1						1	Pain	FLU3~PFIZER\WYETH~4958111~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084124	02/26/1996	MN				U	11/02/1995	pt recv vax & 2 days post vax devel hives & itching;this is one of 4 patients from this site who exp above rxn;				Y					N					PVT	PVT	unk	unk		~ ()~~~In patient	895332001L	1						1	Pruritus; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084125	02/26/1996	MN				U	11/02/1995	pt recv vax & 2 days post vax devel hives & itching;this is one of 4 patients from this site who exp above rxn;				Y					N					PVT	PVT	unk	unk		~ ()~~~In patient	895332002L	1						1	Pruritus; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084126	02/26/1996	MN				U	11/02/1995	pt recv vax & 2 days post vax devel hives & itching;this is one of four patients from this site who exp above rxn;				Y					N					PVT	PVT	unk	unk		~ ()~~~In patient	895332003L	1						1	Pruritus; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084127	02/26/1996	OK	56.0	56		F	10/13/1995	pt recv vax 11OCT95 & devel an inj site rxn characterized by pain,warmth,swelling & redness;this is one of nine patients from this site who exp above rxn p/vax									U	10/11/1995	10/12/1995	1		PVT	OTH	unk	unk		~ ()~~~In patient	895332004L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4958119~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084128	02/26/1996	AL				F	10/25/1995	pt had flu vax accidentally squirt in lt eye & exp a lot of burning;pt was instructed to flush eye,& p/15 mins of flushing the eye was still burning;the eye burning finally resolved;however,pt c/o eye dryness,attributed water irrigation									Y	10/25/1995	10/25/1995	0		OTH	OTH	unk	unk	NKA	~ ()~~~In patient	895313017L	1						1	Pain	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084129	02/26/1996	OK	29.0	29		F	10/13/1995	pt recv vax 11OCT95 & devel inj site rxn characterized by pain,warmth,swelling & redness;this is one of nine patients from this site who exp above rxn p/vax									U	10/11/1995	10/12/1995	1		PVT	OTH	unk	unk		~ ()~~~In patient	895332005L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4958119~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084130	02/26/1996	OK	43.0	43		F	10/13/1995	pt recv vax 11OCT95 & pt devel inj site rxn characterized by pain,warmth,swelling & redness;this is on of nine patients from this site who exp above rxn p/vax;									U	10/11/1995	10/12/1995	1	vaccine lot# 4958119 cult negative for bacterial & viral growth	PVT	OTH	unk	unk		~ ()~~~In patient	895332006L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4958119~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084131	02/26/1996	OK	31.0			F	10/13/1995	pt recv vax & devel an inj site rxn characterized by apin,warmth,swelling & redness;this is one of nine patients from this site who exp above rxn p/vax									U	10/11/1995	10/12/1995	1	vaccine lot# 4958119-cult neg for bacterial & viral growth;	PVT	OTH	unk	unk		~ ()~~~In patient	895332007L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4958119~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084132	02/26/1996	OK	46.0	46		F	10/13/1995	pt recv vax 11OCT95 & pt devel an inj site rxn characterized by pain,warmth,swelling & redness;this is one of nine patients from this site who exp above rxn p/vax									Y	10/11/1995	10/12/1995	1		PUB	PUB	unk	unk		NONE~ ()~~~In patient	895332008L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4958119~UNK~SC A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084133	02/26/1996	OK	45.0	45		F	10/13/1995	pt recv vax 11OCT95 & pt devel an inj site rxn characterized by pain,warmth,swelling & redness;this is one of nine patients from this site who exp above rxn p/vax									Y	10/11/1995	10/12/1995	1		PUB	OTH	unk	NONE	NONE	NONE~ ()~~~In patient	895332009L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Myasthenic syndrome; Paraesthesia	FLU3~PFIZER\WYETH~4958199~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084134	02/26/1996	OK	34.0	33		F	10/13/1995	pt recv vax 11OCT95 & pt devel an inj site rxn characterized by pain,warmth,swelling & redness;this is one of nine patients from this site who exp above rxn p/vax									Y	10/11/1995	10/12/1995	1		PVT	OTH	unk	unk		~ ()~~~In patient	895332010L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4958119~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084135	02/26/1996	OK				U	10/13/1995	pt recv vax 11OCT95 & pt devel an inj site rxn characterized by pain,warmth,swelling & redness;this is one of nine patients from this site who exp above rxn p/vax									U	10/11/1995	10/12/1995	1		PVT	OTH	unk	unk		~ ()~~~In patient	895332011L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4958119~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084136	02/26/1996	TX				F	11/14/1995	pt recv vax 14NOV95 & several hrs later began to exp an inc in BP,rapid shallow resp & a weak feeling;no further details known as of the reporting date;				Y					N	11/14/1995	11/14/1995	0		PUB	OTH	unk	myasthenia gravis		~ ()~~~In patient	895333005L	1						1	Asthenia; Hypertension; Hyperventilation	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084137	02/26/1996	FL	70.0	70		F	11/14/1995	pt recv vax 9NOV95 & that day devel pain & redness @ inj site;pt was evaluated by MD who noted an 8x15cm erythematous area w/purpuric borders;pt also c/o inj site itchy;				Y					Y	11/09/1995	11/10/1995	1		PVT	PVT	Carafate, Xanax, Zaroxolyn, Humibid	bronchitis, HTN, chronic peptic ulcer	NONE	~ ()~~~In patient	895333006L	1						1	Injection site hypersensitivity; Injection site pain; Pruritus; Rash	FLU3~PFIZER\WYETH~4958230~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084138	02/26/1996	NY	41.0	40		F	10/24/1995	pt recv vax 21OCT95 & w/in a few hrs of vax pt devel flushing on both ears & the face,redness @ inj site;pt exp swollen lt ancillary & lt inguinal lymph nodes;addtl info recv 24JAN96;tx w/APAP & cool compresses				Y					N	10/21/1995	10/24/1995	3	NONE	OTH	OTH	Azmacort	unk		~ ()~~~In patient	895333007L	1						1	Injection site hypersensitivity; Lymphadenopathy; Vasodilatation	FLU3~PFIZER\WYETH~4958112~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084139	02/26/1996	IL				F	10/25/1995	pt recv vax 24OCT95 & that evening pt devel pain on side;pt was evaluated by MD who dx pleurisy coincident w/administration of vax;				Y					N	10/24/1995	10/24/1995	0		PVT	PVT	unk	unk		~ ()~~~In patient	895333008L	1						1	Pain; Pleural disorder	FLU3~PFIZER\WYETH~4958137~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084140	02/26/1996	PA	31.0	31		F	10/26/1995	pt recv vax in 1995 & devel an inj site rxn,characterized by redness & induration;this is one of seven patients from this site who exp the above rxn;									Y	10/25/1995	10/25/1995	0		OTH	OTH	unk	unk	penicillin and codeine allergies	~ ()~~~In patient	895333009L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4958100~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084141	02/26/1996	CO	27.0	27		F	10/31/1995	pt recv vax 16OCT95 & devel a sore arm,occasional numbness in the hand,a fever of 102 & h/a w/in 1 hr of vax;pt had recovered;									Y	10/16/1995	10/16/1995	0		PVT	PVT	unk	NONE		~ ()~~~In patient	895333010L	1						1	Headache; Myalgia; Paraesthesia; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084142	02/26/1996	PA				M	11/08/1995	pt devel hives 24hrs p/vax which have not subsided as of the date of this report;pt denies history of allergy to eggs or thimerosol									Y	10/30/1995	10/31/1995	1	no history of allergy to eggs or thimerosol	PUB	OTH	unk	NONE		~ ()~~~In patient	895333011L	1						1	Urticaria	FLU3~PFIZER\WYETH~4958228~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084143	02/26/1996	FL	67.0	67		M	11/06/1995	pt recv vax 30OCT95 & 1NOV95 devel an inj site rxn characterized by a papular,erythematous rash									U	10/30/1995	11/01/1995	2		PVT	OTH	Ativan;Tenormin	URI		~ ()~~~In patient	895333015L	1						1	Injection site hypersensitivity; Rash maculo-papular	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084144	02/26/1996	TX	68.0	68		F	11/10/1995	pt recv vax 9OCT95 & in the month following vax pt has been experiencing numbness & tingling of the entire arm which has not resolved as of the reporting date;pt has not undergone evaluation by MD;									N	10/09/1995	11/07/1995	29		OTH	PUB	unk	unk		~ ()~~~In patient	895333018L	1						1	Paraesthesia	FLU3~PFIZER\WYETH~4958139~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084145	02/26/1996	IN				U	11/03/1995	pt recv vax & devel cellulitis @ the inj site,extending to the elbow									U					PUB	OTH	unk	unk		~ ()~~~In patient	895333025L	1						1	Cellulitis	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084146	02/26/1996	NJ				U	10/18/1995	pt recv vax 17OCT95 & that evening the pt devel an inj site rxn characterized by redness 7 hardness;the rxn has improved;this is one of ten patients from the site who exp above rxn p/vax;									Y	10/17/1995	10/17/1995	0		PVT	PVT	unk	unk		~ ()~~~In patient	895335009L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4958076~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084147	02/26/1996	NJ				U	10/18/1995	pt recv vax & that evening pt devel an inj site rxn characterized by redness & hardness;the rxn has improved;this is one of ten patients from the site who exp above rxn p/vax;									Y	10/17/1995	10/17/1995	0		PVT	PVT	unk	unk		~ ()~~~In patient	895335010L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4958076~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084148	02/26/1996	NJ				U	10/18/1995	pt recv vax 17OCT95 & that evening pt devel inj site rxn characterized by redness & hardness;the rxn has improved;this is one of ten patients from the site who exp above rxn p/vax;									Y	10/17/1995	10/17/1995	0		PVT	PVT	unk	unk		~ ()~~~In patient	895335011L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4958076~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084149	02/26/1996	NJ				U	10/18/1995	pt recv vax 17OCT95 & that evening pt devel an inj site rxn characterized by redness & hardness;the rxn has improved;this is one of ten patients from the site who exp above rxn p/vax									Y	10/17/1995	10/17/1995	0		PVT	PVT	unk	unk		~ ()~~~In patient	895335012L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4958076~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084150	02/26/1996	NJ				U	10/18/1995	pt recv vax 17OCT95 & that evening the pt devel inj site rxn characterized by redness & hardness;the rxn has improved;this is one of ten patients from the site who exp above rxn p/vax;									Y	10/17/1995	10/17/1995	0		PVT	PVT	nk	unk		~ ()~~~In patient	895335013L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4958076~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084151	02/26/1996	NJ				U	10/18/1995	pt recv vax 17OCT95 & that evening pt devel an inj site rxn characterized by redness & hardness;the rxn has improved;this is one of ten patients from the site who experienced above rxn p/vax									Y	10/17/1995	10/17/1995	0		PVT	PVT	unk	unk		~ ()~~~In patient	895335014L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4958076~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084152	02/26/1996	NJ				U	10/18/1995	pt recv vax 17OCT95 & that evening pt devel an inj site rxn characterized by redness & hardness;the rxn has improved;this is one of ten patients from the site who exp above rxn p/vax									Y	10/17/1995	10/17/1995	0		PVT	PVT	unk	unk		~ ()~~~In patient	895335015L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4958076~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084153	02/26/1996	NJ				U	10/18/1995	pt recv vax 17OCT95 & that evening pt devel an inj site rxn characterized by redness & hardness;the rxn has improved;this is one of ten patients from the site who exp above rxn p/vax									Y	10/17/1995	10/17/1995	0		PVT	PVT	unk	unk		~ ()~~~In patient	895335016L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4958076~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084154	02/26/1996	NJ				U	10/18/1995	pt recv vax 17OCT95 & that evening devel an inj site rxn characterized by redness & hardness;the rxn has improved;this is one of ten patients from the site who exp above rxn p/vax;									Y	10/17/1995	10/17/1995	0		PVT	PVT	unk	unk		~ ()~~~In patient	895335017L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4958076~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084155	02/26/1996	PA				U	11/14/1995	pt recv vax & a few days later devel an erythematous rash on the arms & legs;no further details known as of the date of this report									U					OTH	OTH	unk	unk		~ ()~~~In patient	895336002L	1						1	Rash	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084156	02/26/1996	NY	66.0	66		F	11/07/1995	pt recv vax 16OCT95 & 3 to 4 days later c/o h/a;pt developed dryness of the mouth & skin & a hot,burny itchy feeling in face,hand & feet that would pulse then recede;the above sx cont;pt did get teeth cleaned @ the dentist day a/rxn									U	10/16/1995	10/19/1995	3		PVT	PVT	DPH	pt got teeth cleaned day before rxn		~ ()~~~In patient	895336003L	1						1	Dry mouth; Dry skin; Headache; Malaise; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084158	02/26/1996	MN	39.0			F	11/06/1995	pt recv vax 4NOV95 & 5NOV95 pt devel a baseball-sized welt @ the inj site which persisted as of 77NOV95;6NOV95 pt devel hand swelling on the rt hand which has lessened somewhat but does persist;no further details known as of the date rpt									N	11/04/1995	11/05/1995	1		PVT	PVT	unk	NONE		~ ()~~~In patient	895336005L	1						1	Injection site mass; Oedema peripheral	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084159	02/26/1996	NC				U	11/06/1995	pt recv vax & devel an inj site rxn characterized by redness extending from the shoulder to the elbow;pt also exp a sl fever & some joint aches;No further details known as of the reporting date									U	10/01/1995				PVT	PVT	unk	unk		~ ()~~~In patient	895336006L	1						1	Arthralgia; Injection site hypersensitivity; Pyrexia	FLU3~PFIZER\WYETH~4958107~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084162	02/26/1996	OH				U	10/18/1995	pt recv vax 14OCT95 & 16OCT95 was evaluated in a hosp clinical decision unit w/dx of purpura;it is unk whether or not the pt was adm to the hosp as of the date of this report				Y					U	10/14/1995	10/16/1995	2		OTH	OTH	unk	unk		~ ()~~~In patient	895337001L	1						1	Purpura	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084163	02/26/1996	TX				F	10/31/1995	pt devel pancreatitis w/in 24hrs p/vax vax;no further details are known as of the date of this report;									U					OTH	OTH	unk	unk		~ ()~~~In patient	895337002L	1						1	Infection; Pancreatitis	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084165	02/26/1996	NJ	71.0	71		M	10/13/1995	pt recv vax 6OCT95 & by 9OCT95 pt had devel paralysis & numbness of the inj arm;19OCT95 pt had almost complete resolution of sx;pt's MD reportedly feels there may have been some bleeding into the muscle which would account for the sx									Y	10/06/1995	10/09/1995	3		OTH	OTH	unk	unk		~ ()~~~In patient	895337005L	1						1	Haemorrhage; Hypokinesia; Myasthenic syndrome; Paraesthesia; Paralysis	FLU3~PFIZER\WYETH~4958132~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084166	02/26/1996	DC	32.0	32		F	10/27/1995	pt recv vax 24OCT95 p/inj pt devel h/a & cough which had reportedly not resolved;									U	10/12/1995	10/12/1995	0		PVT	PVT	Atarax	unk		~ ()~~~In patient	895337006L	1						1	Cough; Headache	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084167	02/26/1996	OR	45.0			M	10/30/1995	pt recv vax 25OCT95 & 28OCT95 reported a lopsided smile & droopy lt eyelid;reportedly,MD suspects Bell's palsy,although has not yet examined the pt									N	10/25/1995	10/28/1995	3		PVT	PVT	unk	NONE		~ ()~~~In patient	895337007L	1						1	Facial palsy; Hypotonia	FLU3~PFIZER\WYETH~4958117~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084168	02/26/1996	AL	55.0	55		F	10/30/1995	pt recv vax 30OCT95 & pt may have inadvertently recv inj IV as there was some blood in the syringe when aspirating;pt devel sl head pressure & dizziness which resolved;pt's BP was 140/58,pulse was 100									Y	10/30/1995	10/30/1995	0	30OCT95 pulse 100; BP 140/58	PUB	OTH	unk	unk	diabetic	~ ()~~~In patient	895337008L	1						1	Dizziness; Headache	FLU3~PFIZER\WYETH~4958124~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084169	02/26/1996	NE	46.0	46		F	10/27/1995	pt recv vax 24OCT95 & w/in 12-24 hrs devel an inj site rxn characterized as red,raised,warm & 3 inches in circumference									Y	10/24/1995	10/24/1995	0		PVT	PVT	unk	NONE	NONE	~ ()~~~In patient	895337009L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4958137~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084170	02/26/1996	TN				U	10/27/1995	pt recv vax & devel an inj site rxn characterized by erythema & soreness;rxn was five to six inches in diameter									U					PVT	OTH	unk	unk		~ ()~~~In patient	895337010L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4958118~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084171	02/26/1996	WA				U	10/27/1995	pt recv vax 23OCT95 & devel a severe inj site rxn characterized by pain & inflammation;pt has recovered;this is one of six patients from this site who exp the above rxn;									Y	10/23/1995				PVT	PVT	unk	unk	unk	~ ()~~~In patient	895338001L	1						1	Injection site inflammation; Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084172	02/26/1996	WA				U	10/27/1995	pt recv vax 23OCT95 & pt devel a severe inj site rxn characterized by pain & inflammation;pt has recovered;this is one of six patients from this site who exp the above rxn;									Y	10/23/1995				PVT	PVT	unk	unk	unk	~ ()~~~In patient	895338002L	1						1	Injection site inflammation; Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084173	02/26/1996	WA				U	10/27/1995	pt recv vax 23OCT95 & pt devel severe inj site rxn characterized by pain & inflammation;pt has recovered;this is one of six patients from this site who exp the above rxn;									Y	10/23/1995				PVT	PVT	unk	unk	unk	~ ()~~~In patient	895338003L	1						1	Injection site inflammation; Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084174	02/26/1996	WA				U	10/27/1995	pt recv vax 23OCT95 & pt devel a severe inj site rxn characterized by pain & inflammation;pt has recovered;this is one of six patients from this site who exp the above rxn;									Y	10/23/1995				PVT	PVT	unk	unk	unk	~ ()~~~In patient	895338004L	1						1	Injection site inflammation; Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084175	02/26/1996	WA				U	10/27/1995	pt recv vax 23OCT95 & pt devel a severe inj site rxn characterized by pain & inflammation;pt had recovered;this is one of six patients from this site who exp the above rxn									Y	10/23/1995				PVT	PVT	unk	unk	unk	~ ()~~~In patient	895338005L	1						1	Injection site inflammation; Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084176	02/26/1996	TX				U	11/16/1995	pt recv vax & exp severe pain of whole arm,shoulder,& spine;pain has been lessening,but numbness & tingling of arm persists p/1month;									U	10/01/1995				PVT	OTH	unk	unk		~ ()~~~In patient	895338009L	1						1	Pain; Paraesthesia	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084177	02/26/1996	MI	55.0	55		F	11/16/1995	pt recv vax & 3 days later,pt devel & cont to have acute arthritis in the hands & feet;				Y					N	10/31/1995	11/03/1995	3		PVT	OTH	procardia;voltaren	NONE		~ ()~~~In patient	895338010L	1						1	Arthritis	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0084178	02/26/1996					U	11/13/1995	pt recv vax & devel nerve damage;no other info is available as of the date of this report;the reporter wishes to remain anonymous									U					OTH	OTH	unk	unk		~ ()~~~In patient	895338011L	1						1	Neuropathy	FLU3~PFIZER\WYETH~~UNK~SC~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084179	02/26/1996	WI	47.0	47		F	10/26/1995	pt recv vax & w/in 48hrs of inj devel bradycardia (exact heart rate not specified);the bradycardia persisted for an hr & then resolved;				Y					Y	10/17/1995	10/19/1995	2		PVT	PVT	LOPID, ULTRAM	NONE	PENICILLIN ALLERGY; HYPERTENSION,  HIGH CHOLESTEROL	~ ()~~~In patient	895338012L	1						1	Bradycardia; Dizziness; Hyperhidrosis; Pallor	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084180	02/26/1996	MT	36.0	36		M	11/16/1995	pt recv vax & exp inj sit pain which has persisted since the date of the inj;no redness was noted @ inj site;									N	10/25/1995	10/25/1995	0		PVT	PVT	unk	NONE	ARTHRITIS	~ ()~~~In patient	895338013L	1						1	Hypokinesia; Injection site pain; Myalgia	FLU3~PFIZER\WYETH~4958112~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084181	02/26/1996	IL				U	11/21/1995	pt recv vax & 24hrs p/vax pt devel a febrile illness									U					OTH	OTH	unk	unk		~ ()~~~In patient	895338014L	1						1	Malaise; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084182	02/26/1996	ND	49.0	49		F	11/29/1995	pt recv vax & devel arm achiness;the next day devel reddened area (size of 50 cent piece) & edema;edema dec by the 3rd day,but the redness progressed to a 5-6 area;redness improved but has not totally resolved;									U	11/24/1995	11/24/1995	0		PVT	PVT	Estrogen patch;progesterone	unk		~ ()~~~In patient	895338015L	1						1	Myalgia; Oedema peripheral; Rash	FLU3~PFIZER\WYETH~4958140~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084183	02/26/1996	TX				U	11/01/1995	pt recv vax & devel fever of 102;no further details known as of the date of this report;this is one of three patients from this site who exp above rxn;									U					OTH	OTH	unk	unk		~ ()~~~In patient	895338016L	1						1	Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084184	02/26/1996	MO	41.0	40		F	11/21/1995	pt recv vax & immed devel pain @ inj site & in the arm;pt was tx w/several doses of Ibuprofen w/little relief;pt has had diff lifting arm over head d/t pain;primary MD cannot find an organic cause of pain;dx rotator cuff tendinitis				Y					U	10/28/1995	10/28/1995	0	x-ray of arm-neg	PUB	PVT	unk	unk		~ ()~~~In patient	895338018L	1						1	Hypokinesia; Injection site pain; Tendon disorder	FLU3~PFIZER\WYETH~4958232~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084185	02/26/1996	OH	38.0	38		F	11/08/1995	pt recv vax 19OCT95 & pt reported immed pain @  the inj site,which remained very painful for 2 days;the soreness has not resolved as of the reporting date;pt also reports having diff raising lt upper arm secondary to the pain;no redness									N	10/19/1995	10/19/1995	0		PUB	OTH	premarin/provera	NONE		~ ()~~~In patient	895339004L	1						1	Hypokinesia; Injection site pain	FLU3~PFIZER\WYETH~4958110~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084186	02/26/1996	NH	46.0	46		F	11/15/1995	pt recv vax & devel soreness & swelling @ inj site,as well as diff breathing;no treatment was necessary;									Y	12/02/1994	12/02/1994	0		PVT	OTH	unk	none	none	~ ()~~~In patient	895340004L	1						1	Dyspnoea; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4948145~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084187	02/26/1996	NY	41.0	41		M	11/27/1995	pt recv vax & exp bilat stocking-glove neuropathy w/dec sensation in both hands & feet;addtl info was recv 2FEB96;pt was fully recovered as of 2FEB96;				Y					U	11/24/1995	11/26/1995	2		PVT	PVT	unk	NONE	PCN, sulfa	~ ()~~~In patient	895340009L	1						1	Hypoaesthesia; Neuropathy	FLU3~PFIZER\WYETH~4958084~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084188	02/26/1996	IN				U	11/09/1995	pt recv vax & devel local rxn characterized by itching,swelling @ site of inj & hard knots;pt also had a fever;no other details were known as of reporting date									U					PVT	OTH	unk	unk		~ ()~~~In patient	895340012L	1						1	Injection site mass; Injection site oedema; Pruritus; Pyrexia	FLU3~PFIZER\WYETH~4958110~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084189	02/26/1996	PA	67.0	67		F	11/16/1995	pt recv vax & devel vasculitis,characterized by a rash on the upper & lower areas of both legs;pt also exp joint stiffness & swelling in knees & ankles;presented to ER on 15NOV95 & treated w/pred & DPH;				Y					U	11/14/1995	11/16/1995	2		PVT	PVT	antivert, coumadin, lanoxin, lasix, proventil	unk	rash on legs 5 days p/flu vax given in 1994;	~ ()~~~In patient	895340015L	1						1	Hypertonia; Osteoarthritis; Rash; Vasculitis	FLU3~PFIZER\WYETH~~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084191	02/26/1996	OH	77.0	77		M	12/05/1995	pt recv vax & devel a red,itchy area on lip,which progressed to welts on arms that looked like a spider bite;sx had progressed to the entire body & were becoming larger;pt was treated w/antihistamine									N	10/20/1995	11/15/1995	26		PVT	PVT	Mevacor, vitamins	none	allergy -penicillin	~ ()~~~In patient	895346006L	1						1	Pruritus; Rash; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084192	02/26/1996	KY				U	12/01/1995	pt recv vax & exp a flare up of uveitis (assoc w/herpes simplex);no other info was known as of reporting date				Y					U					OTH	OTH	unk	unk		~ ()~~~In patient	895346008L	1						1	Uveitis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084193	02/26/1996	CO	48.0	47		F	11/28/1995	pt recv vax & devel nausea,dry heaves,& intermittent h/a;no other info was available as of reporting date									U	11/16/1995	11/17/1995	1		OTH	OTH	unk	NONE		~ ()~~~In patient	895347001L	1						1	Headache; Nausea; Vomiting	FLU3~PFIZER\WYETH~~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084194	02/26/1996	AZ	33.0	33		F	11/27/1995	pt recv flu vax instead of TB skin test,pt devel a reddened area @ inj site;no other details were known as of the reporting date;									Y	11/27/1995	11/27/1995	0		PUB	PUB	TB skin test 27NOV95 to unk; TB skin test 15NOV95	NONE		~ ()~~~In patient	895347002L	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4958120~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084195	02/26/1996	SC				M	11/28/1995	pt recv vax & devel tinnitus & unilateral sudden hearing loss that was classified as profound;								Y	U					OTH	OTH	unk	unk		~ ()~~~In patient	895347004L	1						1	Deafness; Myalgia; Tinnitus	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0084196	02/26/1996	MN	25.0	25		F	12/01/1995	pt recv vax & immed devel arm numbness & tingling;pt devel low grade fever of 101 & an inj site rxn,characterized by golf ball size lump;the lump was very red & hot to touch;tx DPH				Y					Y	11/24/1995	11/25/1995	1		PVT	PVT	unk	NONE	pt had influenza in 1991	~ ()~~~In patient	895348001L	1						1	Injection site hypersensitivity; Injection site mass; Paraesthesia; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4958234~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084197	02/26/1996	TX	57.0	57		F	12/04/1995	pt recv vax 10OCT95 & devel numbness & tingling in rt arm;also exp muscle weakness characterized by pain in back & chest being unable to stand on feet;									Y	10/10/1995	10/24/1995	14	cardiac workup was fine;EMG on rt arm showed pinched nerves in wrist & elbow	OTH	OTH	unk	unk	history of breast cancer	~ ()~~~In patient	895348002L	1						1	Back pain; Chest pain; Hypokinesia; Myasthenic syndrome; Neuralgia; Paraesthesia	FLU3~PFIZER\WYETH~4958113~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084198	02/26/1996	CA	73.0	73		F	12/01/1995	pt recv vax 17OCT95 & w/in 2 days devel arm pain,tingling in hand & fingers & no strength in fingers 4 & 5;saw neurologist on 15NOV95 who allegedly told pt there was no nerve involvement;dx muscular pain d/t vaccine;				Y					N	10/17/1995	10/18/1995	1	nerve conduction studies-nl	PVT	PVT	unk	NONE		~ ()~~~In patient	895348004L	1						1	Myalgia; Myasthenic syndrome; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4958150~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084199	02/26/1996	MI	50.0	50		F	11/28/1995	pt recv vax & devel joint pain in the arms,feet,knees & ankles;no other info was known as of reporting date;									N	11/02/1995	11/02/1995	0		OTH	OTH	ASA	NONE		~ ()~~~In patient	895348006L	1						1	Arthralgia	FLU3~PFIZER\WYETH~~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084200	02/26/1996	OH	81.0	81		M	11/20/1995	pt recv vax 1NOV95 & devel a fine,pink rash on face,back & arms;also c/o itchiness;pt was treated w/DPH & is recovered;									Y	11/01/1995	11/05/1995	4	MD thought maybe allergic to thimerosal or gentamicin	OTH	PVT	unk	CHF, muscle disuse atrophy, UTI		~ ()~~~In patient	895348007L	1						1	Pruritus; Rash	FLU3~PFIZER\WYETH~4958124~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084201	02/26/1996	CA				U	12/01/1995	pt recv vax & devel an inj site rxn characterized by erythema,sl welt,redness & itching;this is one of 6 patients from this site who devel this rxn;									U					PVT	PVT	unk	unk		~ ()~~~In patient	895352003L	1						1	Injection site hypersensitivity; Pruritus; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4958107~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084202	02/26/1996	CA				U	12/01/1995	pt recv vax & devel flu-like sx characterized by nausea,vomiting,myalgia,& loss of appetite lasting more than 24hrs;									U					PVT	PVT	unk	unk		~ ()~~~In patient	895352004L	1						1	Anorexia; Influenza; Myalgia; Nausea; Vomiting	FLU3~PFIZER\WYETH~4958107~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084248	02/26/1996	CA				F	11/30/1995	pt recv vax & exp pain @ the inj site,& neurological disorder,characterized by severe sweating,arm jerking,muscle twitching & numbness in the inj arm;no other details were known @ the time of this report									U					OTH	OTH	unk	unk		~ ()~~~In patient	895352005L	1						1	Hyperhidrosis; Injection site pain; Muscle twitching; Paraesthesia	FLU3~PFIZER\WYETH~4958122~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084249	02/26/1996	CO	40.0	40		F	11/08/1995	pt recv vax 17OCT95 & w/in 12hrs devel a fever (100 fahrenheit),chills,& flu-like sx,characterized by aches & resp sx;									U	10/17/1995	10/18/1995	1		PVT	PVT	unk	NONE		~ ()~~~In patient	895353002L	1						1	Arthralgia; Chills; Influenza; Myalgia; Pyrexia; Respiratory disorder	FLU3~PFIZER\WYETH~4958115~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084250	02/26/1996	CO	35.0	35		F	11/08/1995	pt recv vax 7NOV95 & immed p/vax devel tingling down arm to wrist & fingers;									U	11/07/1995	11/07/1995	0		PVT	PVT	unk	NONE		~ ()~~~In patient	895353003L	1						1	Paraesthesia	FLU3~PFIZER\WYETH~4958129~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084251	02/26/1996	CO	50.0	50		F	11/08/1995	pt recv vax 17OCT95 pt devel nausea,joint pain (shoulders,hips,knees),a swollen arm,h/a,& was itchy									U	10/17/1995	10/18/1995	1		PVT	PVT	unk	NONE		~ ()~~~In patient	895353004L	1						1	Arthralgia; Headache; Nausea; Oedema peripheral; Pruritus	FLU3~PFIZER\WYETH~4958115~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084252	02/26/1996	CO	32.0	32		F	11/08/1995	pt recv vax 24OCT95 & that evening devel a fever (100.2),chills & myalgia;									U	10/24/1995	10/24/1995	0		PVT	PVT	unk	NONE		~ ()~~~In patient	895353005L	1						1	Chills; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4958129~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084253	02/26/1996	CO	39.0	38		F	11/08/1995	pt recv vax & devel a h/a,fever (100),muscle aches;									U	10/16/1995	10/16/1995	0		PVT	PVT	unk	NONE		~ ()~~~In patient	895353007L	1						1	Headache; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4958115~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084254	02/26/1996	CA				F	12/15/1995	pt recv vax 13DEC95 & became violently ill & exp palpitations,nausea & flu-like sx;									U	12/13/1995	12/13/1995	0		OTH	OTH	unk	unk		~ ()~~~In patient	895353008L	1						1	Influenza; Malaise; Nausea; Palpitations	FLU3~PFIZER\WYETH~~UNK~SC~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084255	02/26/1996	PA				U	12/08/1995	25 out of 8600 patients who recv flu vax using a needle free inj system manufactured by biotect devel inj site soreness;									Y					PVT	OTH	unk	unk		~ ()~~~In patient	895353009L	1						1	Injection site pain	FLU3~PFIZER\WYETH~4958124~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084256	02/26/1996	CA				M	11/30/1995	pt recv vax & devel pain @ inj site as well as numbness;no other details were known as of the reporting date;									U					OTH	OTH	unk	unk		~ ()~~~In patient	895353010L	1						1	Injection site pain; Paraesthesia	FLU3~PFIZER\WYETH~4958122~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084257	02/26/1996	CA	56.0			M	12/13/1995	pt recv vax & 5 days later devel pain in joints,fatigue & fever;sx cont x 2 wk;tx w/pred x 1 wk;on 13DEC95 sx returned & have worsened;pt reported diff using hands & ambulating,fever,& fatigue;				Y					U				neg RF & lupus tests; sed rat inc to 45	PVT	PVT	unk	unk		~ ()~~~In patient	895355001L	1						1	Arthralgia; Asthenia; Hypokinesia; Pyrexia; Red blood cell sedimentation rate increased	FLUX~UNKNOWN MANUFACTURER~~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0084258	02/26/1996	CA	56.0	55		F	12/13/1995	pt recv vax in 1995 & devel aching joints (settled in bilat thumbs) & legs;sx have resolved;									Y	11/01/1995	11/05/1995	4		PUB	PVT	Estraderm, Tenormin	none	none	~ ()~~~In patient	895355003L	1						1	Arthralgia; Chills; Dizziness; Pyrexia; Rash	FLU3~PFIZER\WYETH~4958079~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084259	02/26/1996	NE	67.0	67		M	12/04/1995	pt recv vax 10OCT95 & several wk later,pt devel delayed onset of diffuse myalgia & gen arthralgia;no other info was available as of reporting date									U	10/10/1995			sed rate was 52;RA & lupus r/o	OTH	OTH	Biaxin, Guafenicin	NONE		~ ()~~~In patient	895355004L	1						1	Arthralgia; Myalgia; Red blood cell sedimentation rate increased	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084260	02/26/1996	CA				F	11/09/1995	pt recv vax 6NOV95 & devel swelling the size of an orange,@ inj site;no other details were available as of the reporting date;									U	11/06/1995				OTH	OTH	unk	unk		~ ()~~~In patient	895355006L	1						1	Injection site oedema	FLU3~PFIZER\WYETH~495811~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084261	02/26/1996	TN	21.0			M	12/20/1995	pt recv vax & devel flu-like sx characterized by h/a,chills,& fever of 100.4;									U	12/17/1995	12/19/1995	2		OTH	OTH	unk	unk		~ ()~~~In patient	895357001L	1						1	Chills; Headache; Influenza; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084262	02/26/1996	UT	60.0			M	12/21/1995	pt recv vax & pt's arm has been aching & has not been able to lie on the arm;									N	10/11/1995	10/11/1995	0		OTH	PUB	unk	unk		~ ()~~~In patient	895357002L	1						1	Myalgia	FLU3~PFIZER\WYETH~4958123~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084263	02/26/1996	FL	44.0	44		F	12/27/1995	pt recv vax 20DEC95 & c/o tenderness on the lt shoulder & lt side of the neck;the tenderness devel into swollen lymph nodes w/a pea sized,palpable knot;sx persist,& the know has gotten larger				Y					Y	12/20/1995	12/22/1995	2		PUB	PVT	premarin	NONE		~ ()~~~In patient	896003003L	1						1	Lymphadenopathy; Myalgia; Neck pain; Pain; Skin nodule	FLU3~PFIZER\WYETH~4958079~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084264	02/26/1996	MI	50.0	50		M	12/28/1995	pt recv vax 1DEC95 & later day,devel;a severe itchy feeling all over body,w//no physical sx;sx inc in severity & the itchy feeling peeked approx 8 days p/vax;tx w/DPH & pred;				Y					N	11/30/1995	11/30/1995	0		PVT	PVT	Propulsid, Zantac, diabeta, brethaire inhaler	NONE		~ ()~~~In patient	896003004L	1						1	Pruritus	FLU3~PFIZER\WYETH~~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084266	02/26/1996	IA	39.0	39		F	11/22/1995	pt recv vax 9NOV95 & later that day devel an inj site rxn,characterized by numbness & burning;pt devel numbness from the neck down to the lower spine;approx 24 to 48hrs p/vax devel weakness in arms & had trouble lifting them;									N	11/09/1995	11/09/1995	0		OTH	OTH	unk	unk		~ ()~~~In patient	896003011L	1						1	Asthenia; Hypokinesia; Injection site pain; Myasthenic syndrome; Paraesthesia	FLU3~PFIZER\WYETH~4958103~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084267	02/26/1996	TX				U	11/03/1995	pt recv vax & devel flu-like sx characterized by fever,malaise,deep body/muscle aches,h/a,& nausea;this is one of three patients who exp above rxn @ this site;				Y					U					PUB	PUB	unk	unk		~ ()~~~In patient	896004004L	1						1	Headache; Influenza; Malaise; Myalgia; Nausea; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084268	02/26/1996	TX				U	11/03/1995	pt recv vax & devel flu-like sx characterized by fever,malaise,deep body/muscle aches,h/a,nausea;this is one of three patients who exp above rxn @ this site;				Y					U					PUB	PUB	unk	unk		~ ()~~~In patient	896004005L	1						1	Headache; Influenza; Malaise; Myalgia; Nausea; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084269	02/26/1996	MN	50.0			F	11/06/1995	pt recv vax 3NOV95 & 4NOV95 devel a silver dollar sized welt @ the inj site;pt has not yet recovered;									N	11/03/1995	11/04/1995	1		PVT	PVT	unk	NONE		~ ()~~~In patient	896010011L	1						1	Injection site hypersensitivity; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084270	02/26/1996	MN	76.0	76		F	11/06/1995	pt recv vax 4NOV95 & devel urticaria @ inj site w/itching;pt has not recovered as of the reporting date;									N	11/04/1995	11/05/1995	1		PVT	PVT	unk	NONE		~ ()~~~In patient	896010012L	1						1	Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084271	02/26/1996	NY	34.0	34		F	12/19/1995	pt recv vax 15NOV95 & devel a red,circular,flat,sl itchy rash by 10PM which lasted for 3 days;also exp dizziness & nausea w/in 3hrs of inj;pt recovered;									Y	11/15/1995	11/15/1995	0		PUB	OTH	Synthroid	NONE		~ ()~~~In patient	896015006L	1						1	Dizziness; Nausea; Pruritus; Rash	FLU3~PFIZER\WYETH~~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084272	02/26/1996	PA	42.0	42		F	10/26/1995	pt recv vax OCT95 & devel an inj site,rxn,characterized by redness & induration;this is one of seven patients from this site who exp the above rxn;									Y	10/26/1995	10/26/1995	0		OTH	OTH	none	unk	none	~ ()~~~In patient	896036006L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4958100~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084273	02/26/1996	PA	36.0	36		F	10/26/1995	pt recv vax & devel an inj site rxn,characterized by redness & induration;this is one of seven patients from this site who exp the above rxn;									Y	10/17/1995	10/19/1995	2		OTH	OTH	unk	unk		~ ()~~~In patient	896036007L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4958100~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084274	02/26/1996	PA	29.0	29		F	10/26/1995	pt recv vax & devel an inj site rxn,characterized by redness & induration;this is one of seven patients from this site who exp the above rxn;									Y	10/16/1995	10/19/1995	3		OTH	OTH	unk	unk		~ ()~~~In patient	896036008L	1						1	Injection site hypersensitivity; Injection site mass; Migraine	FLU3~PFIZER\WYETH~4958100~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084275	02/26/1996	PA	47.0	47		F	10/26/1995	pt recv vax 1OCT95 & devel an inj site rxn,characterized by redness & induration;this is one of seven patients from this site who exp the above rxn;									Y	10/16/1995	10/16/1995	0		OTH	OTH	unk	unk	none	~ ()~~~In patient	896036009L	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~49584100~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084276	02/26/1996	PA	25.0	25		F	10/26/1995	pt recv vax OCT95 & devel an inj site rxn,characterized by redness & induration;this is one of seven patients from this site who exp the above rxn;									Y	10/16/1995	10/16/1995	0		OTH	OTH	synthroid, orthonovum 7/7/7	unk	allergic to penicillin and sulfa; hypothyroidism	~ ()~~~In patient	896036010L	1						1	Dizziness; Injection site hypersensitivity; Injection site mass; Nausea; Vomiting	FLU3~PFIZER\WYETH~4958100~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084277	02/26/1996	PA	58.0	58		F	10/26/1995	pt recv vax OCT95 & devel inj site rxn,characterized by redness & induration;this is one of sever patients from this site who exp the above rxn;									Y	10/24/1995	10/26/1995	2		OTH	PVT	cardizem, cardura	unk	hypertension	~ ()~~~In patient	896036011L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4958100~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084278	02/26/1996	WA				U	10/23/1995	pt recv vax & devel an inj site rxn characterized by impressive redness & soreness;pt also had a lot of arm pain;rxn has lasted 5-7 days;this is one of 3 patients from this site who exp above rxn;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896036016L	1						1	Injection site hypersensitivity; Injection site pain; Pain	FLU3~PFIZER\WYETH~4958119~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084279	02/26/1996	WA				U	10/23/1995	pt recv vax & devel an inj site rxn characterized by impressive redness & soreness;pt also had a lot of arm pain;rxn has lasted 5-7 days;this is one of 3 patients from this site who exp above rxn;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896036017L	1						1	Injection site hypersensitivity; Injection site pain; Pain	FLU3~PFIZER\WYETH~4958119~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084280	02/26/1996	CA				U	12/01/1995	pt recv & devel flu-like sx characterized by nausea,vomiting,myalgia,& loss appetite lasting more than 24hrs;				Y					U					PVT	PVT	unk	unk		~ ()~~~In patient	896036019L	1						1	Anorexia; Influenza; Myalgia; Nausea; Vomiting	FLU3~PFIZER\WYETH~4958107~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084281	02/26/1996	CA				U	12/01/1995	pt recv vax & devel an inj site rxn characterized by erythema,sl welt,redness & itching;this is one of 6 patients from this site who devel this rxn									U					PVT	PVT	unk	unk		~ ()~~~In patient	896036020L	1						1	Injection site hypersensitivity; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4958107~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084282	02/26/1996	CA				U	12/01/1995	pt recv vax & devel an inj site rxn characterized by erythema,sl welt,redness & itching;this is one of 6 patients from this site who devel this rxn;									U					PVT	PVT	unk	unk		~ ()~~~In patient	896036021L	1						1	Injection site hypersensitivity; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4958107~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084283	02/26/1996	CA				U	12/01/1995	pt recv vax & devel inj site rxn characterized by erythema,sl welt,redness & itching;this is one of 6 patients from this site who devel this rxn;									U					PVT	PVT	unk	unk		~ ()~~~In patient	896036022L	1						1	Injection site hypersensitivity; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4958107~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084284	02/26/1996	CA				U	12/01/1995	pt recv vax & devel an inj site rxn characterized by erythema,sl welt,redness & itching;this is one of 6 patients from this site who devel this rxn;									U					PVT	PVT	unk	unk		~ ()~~~In patient	896036023L	1						1	Injection site hypersensitivity; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4958107~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084285	02/26/1996	CA				U	12/01/1995	pt recv vax & devel an inj site rxn characterized by erythema,sl welt,redness & itching;this is one of 6 patients from this site who devel this rxn;									U					PVT	PVT	unk	unk		~ ()~~~In patient	896036024L	1						1	Injection site hypersensitivity; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4958107~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084286	02/26/1996	PA	38.0	38		F	11/01/1995	pt recv vax 26OCT95 & w/in 24hrs throat felt like it was closing up;addtl info recv 20DEC95;pt was fully recovered as of 28NOV95;this is one of four patients from this site to report adverse rxn									Y	10/26/1995	10/26/1995	0		OTH	OTH	unk	NONE		~ ()~~~In patient	896039007L	1						1	Laryngospasm	FLU3~PFIZER\WYETH~4958068~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084287	02/26/1996	PA				F	11/01/1995	pt recv vax 26OCT95 & devel a red & swollen arm,body aches & numbness from shoulder,around back of neck & down to lt arm,as well as stuffy nose & sore throat;sx persisted for about 5-6 days;pt was fully recovered as of 30NOV95;									Y	10/26/1995				OTH	OTH	unk	NONE		~ ()~~~In patient	896039008L	1						1	Myalgia; Oedema peripheral; Paraesthesia; Pharyngitis; Rhinitis; Vasodilatation	FLU3~PFIZER\WYETH~4958068~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084288	02/26/1996	NE	34.0	34		F	10/27/1995	pt recv vax 24OCT95 & w/in 1 hr devel an inj site rxn characterized as red,raised,warm & 3 inches in circumference									Y	10/24/1995	10/25/1995	1		PVT	PVT	unk	unk		~ ()~~~In patient	896039026L	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4958137~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084290	02/26/1996	NE	25.0	25		F	10/27/1995	pt recv vax 24OCT95 & w/in 12-24 hrs devel an inj site rxn characterized as red,raised,warm & 3 inches circumference;									U	10/24/1995	10/24/1995	0		PVT	PVT	unk	unk		~ ()~~~In patient	896039028L	1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~PFIZER\WYETH~4958137~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084291	02/26/1996	NE	40.0	40		F	10/27/1995	pt recv vax & w/in 12-24 hrs devel an inj site rxn characterized as red,raised,warm & 3 inches in circumference									U	10/24/1995	10/24/1995	0		PVT	PVT	unk	unk		~ ()~~~In patient	896039029L	1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~PFIZER\WYETH~4958137~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084292	02/26/1996	NE	41.0	41		F	10/27/1995	pt recv vax 24OCT95 & w/in 12-24 hrs devel an inj site rxn characterized as red,raised,warm & 3 inches in circumference;									U	10/24/1995	10/24/1995	0		PVT	PVT	unk	unk		~ ()~~~In patient	896039030L	1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~PFIZER\WYETH~4958137~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084293	02/26/1996	NE	59.0	59		F	10/27/1995	pt recv vax 24OCT95 & w/in 12-24 hrs devel an inj site rxn characterized as red,raised,warm & 3 inches in circumference									U	10/24/1995	10/24/1995	0		PVT	PVT	unk	unk		~ ()~~~In patient	896039031L	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4958137~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084294	02/26/1996	PA	53.0	52		F	11/01/1995	pt recv vax 26OCT95 & devel redness & swelling @ inj site;also c/o itching & aching for a couple of days;the patient was fully recovered as of 20DEC95;this is one of four patients from this site to report adverse rxn									Y	10/26/1995	10/26/1995	0		OTH	OTH	unk	unk		~ ()~~~In patient	896040005L	1						1	Injection site hypersensitivity; Injection site oedema; Myalgia; Pruritus	FLU3~PFIZER\WYETH~4958068~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084295	02/26/1996	MA				U	11/03/1995	pt recv vax 1NOV95 & devel an inj site rxn characterized by induration & erythema;pt also exp malaise & nausea;this is one of four patients from this site who exp above sx									U	11/01/1995	11/02/1995	1		OTH	OTH	unk	unk		~ ()~~~In patient	896040008L	1						1	Injection site hypersensitivity; Injection site mass; Malaise; Nausea	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084296	02/26/1996	MA				U	11/03/1995	pt recv vax 1NOV95 & devel an inj site rxn characterized by induration & erythema;pt also exp malaise & nausea;this is one of four patients from this site who exp above sx									U	11/01/1995	11/02/1995	1		OTH	OTH	unk	unk		~ ()~~~In patient	896040009L	1						1	Injection site hypersensitivity; Injection site mass; Malaise; Nausea	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084297	02/26/1996	MA				U	11/03/1995	pt recv vax 1NOV95 & devel an inj site rxn characterized by induration & erythema;pt also exp malaise & nausea;this is one of four patients from this site who exp above sx									U	11/01/1995	11/02/1995	1		OTH	OTH	unk	unk		~ ()~~~In patient	896040010L	1						1	Injection site hypersensitivity; Injection site mass; Malaise; Nausea	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084298	02/26/1996	KY				U	10/31/1995	pt recv vax & devel diffuse,itchy hives,in addtl to an itchy & swollen throat;this is one of two patients from this site who exp the above rxn									U					OTH	OTH	unk	unk		~ ()~~~In patient	896044003L	1						1	Laryngospasm; Pruritus; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084299	02/26/1996	TX				U	11/16/1995	pt recv vax & exp severe pain of whole arm,shoulder,& spine;pain has been lessening,but numbness & tingling of arm persists p/one month;									U	10/01/1995				PVT	OTH	unk	unk		~ ()~~~In patient	896044004L	1						1	Back pain; Pain; Paraesthesia	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084300	02/26/1996	TX				U	11/16/1995	pt recv vax & exp severe pain of whole arm,shoulder,& spine;pain has been lessening,but numbness & tingling of arm persists p/one month;									U	10/01/1995				PVT	OTH	unk	unk		~ ()~~~In patient	896044005L	1						1	Back pain; Pain; Paraesthesia	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084301	02/26/1996	TX				U	11/01/1995	pt devel a fever of 102;no further details known as of the date of this report;this is one of three patients from this site who exp above rxn									U					OTH	OTH		unk		~ ()~~~In patient	896045002L	1						1	Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0084302	02/26/1996	TX				U	11/01/1995	pt recv vax & devel a fever of 102;no further details known as of the date of this report;this is one of three patients from this site who exp above rxn;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896045033L	1						1	Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079543	02/28/1996	NM	31.0	31		F	11/15/1995	pt recv vax & noticed immed rxn of erythema @ inj site radiating to shoulder;pt c/o pins & needles,shakiness & anxiety;gave epi;c/o dizziness,numbness of extremities,clamminess,BP 158/64,P90,R22;taken to ER;c/o tightness throat & SOB				Y					Y	11/15/1995	11/15/1995	0	NONE	PVT	PVT	NONE	denies	reports sensitivity to meds	~ ()~~~In patient		1						4	Anxiety; Dizziness; Dyspnoea; Hypoaesthesia; Hypotension; Injection site hypersensitivity; Laryngospasm; Paraesthesia	FLU3~PFIZER\WYETH~4958089~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~4	USA	Emergency room visit	Influenza
0083202	02/28/1996	IN	84.0	83		M	01/18/1996	pt recvd vax & c/o rt hip pain & upper leg pain 6NOV95;exp numbness in lips& eyes bilat w/inability to focus on 10NOV95;pt hosp for bifacial paralysis & lower extremity weakness;GBS dx;c/o dysuria;22NOV95 mild lt peripheral facial weakness					Y					11/02/1995	11/06/1995	4	11NOV95 MRI of brain w/contrast: gen atrophy consistent w/pt age;findings of small vessel ischemic change in the periventricular white matter;13NOV95 MRI of lumbar spine w or w/o contrast-dis degeneration and mild circumferential bulge	UNK	UNK	goserelin acetate; colace, pepcid, vicodin, compazine;		cerebrovascular accident;bone metastases (rt hip) from prostate cancer;	~ ()~~~In patient		1						1	Amblyopia; Arthralgia; Cerebral ischaemia; Dysphagia; Facial palsy; Guillain-Barre syndrome; Myasthenic syndrome; Paraesthesia oral	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0083212	02/28/1996	KY	30.0			F	02/09/1996	pt recv flu vax during the 1st trimester of pregnancy;recently,20wk gestation pt underwent ultrasound exam;It was noted on ultrasound that the fetus only has one hand;no addtl info is known @ this time									N				ultrasound uterus-fetus w/one hand missing	PVT	PVT	unk	unk		~ ()~~~In patient	896043002L	1						1	Foetal disorder; Congenital anomaly; Foetal disorder	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0084265	02/28/1996	TX	38.0	38		F	11/20/1995	pt recv vax 6NOV95 & the next day devel a large,painful,edematous area covering upper rt arm & axilla;also devel an itchy throat;pt was treated w/Epi,DPH & cortisone;p/sx pt exp numbness & tingling of entire rt arm;				Y					N	11/06/1995	11/07/1995	1		PVT	OTH	unk	NONE		~ ()~~~In patient	896003009L	1						1	Oedema peripheral; Pain; Paraesthesia; Pruritus	FLU3~PFIZER\WYETH~4958133~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0083302	02/29/1996	CA	44.0	44		F	01/08/1996	pt recvd vax; exp high fever, body aches; HA; extreme rash at inject site only;eyes sensitive to light;				Y					Y	01/05/1996	01/05/1996	0		PUB	PUB		none	rhinitis, heart disease	~ ()~~~In patient	CA960012	1						1	Headache; Injection site hypersensitivity; Myalgia; Photosensitivity reaction; Pyrexia	FLU3~PFIZER\WYETH~495815~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1541A~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0083303	02/29/1996	CA	63.0	63		F	01/17/1996	pt recv vax;rt arm swollen including axillary area;by am rt fingers,elbow & knee were swollen & red;joint swelling & redness cont;to md who felt poss vax rxn;lab test showed acute inflammation;				Y					N	10/19/1995	10/19/1995	0		PUB	PUB	zestril;	none	hypertension; defective heart valve;	~ ()~~~In patient	CA960008	1						1	Laboratory test abnormal; Oedema peripheral; Osteoarthritis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F6119~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0151B~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0083433	03/04/1996	IL	52.0	52		M	02/26/1996	pt c/o fever,aches,knot in arm;inj site was enlarged,hard,& warm to touch;went to MD & was prescribed Anaprox				Y					Y	10/24/1995	10/25/1995	1	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	IL960019	1						1	Injection site mass; Injection site oedema; Myalgia; Pyrexia; Vasodilatation	FLU3~PARKE-DAVIS~00975P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~CONNAUGHT LABORATORIES~5C71114~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0080700	03/05/1996	NJ	29.0	29		M	02/27/1996	1530 immed redness & swelling @ site;DPH given rechecked @ 410PM no change									Y	12/28/1995	12/28/1995	0	NONE	PVT	PVT		poss OM	NONE	NONE~ ()~~~In patient		1						2	Injection site hypersensitivity; Injection site oedema; Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4958109~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4958109~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0083504	03/06/1996	IN	60.0	60		F	01/30/1996	pt had flu-like sx p/vax;pain down rt arm achy & tender;pt returned to MD office in JAn still c/o achy & tender rt arm;MD stated a tendonitis type condition in rt deltoid area;										11/10/1995	01/30/1996	81		UNK	UNK			nka; no prior problems related to yearly flu vax	~ ()~~~In patient		1						1	Influenza; Myalgia; Pain; Tendon disorder	FLU3~PFIZER\WYETH~4958073~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083509	03/06/1996	CA	74.0			F		pt recvd vax 9OCT95 next day exp involuntary jerking;										10/09/1995	10/10/1995	1	NONE	UNK	UNK	Catpress;HCTZ, KDUR, LTX		familial tremor, labile hypertension;CAD;nicotinism	~ ()~~~In patient		1						1	Muscle twitching	FLU3~PFIZER\WYETH~4958117~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083515	03/08/1996	CA				F	01/11/1996	pt recvd vax;devel a resp disorder; to hosp & required intubation & mechanical ventilation;			Y	Y	Y	10			Y	10/23/1995	10/24/1995	1		PUB	PUB				~ ()~~~In patient	896053007L	1						1	Respiratory disorder	FLU3~PFIZER\WYETH~4958088~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0083517	03/08/1996	AZ	3.0	2	1	F	02/21/1996	pt recv vax;31oct95 devel fever of 106 & exp sz lasting over 1 hr;adm to hosp;exp oth sz & coma intermittently;this resulted in 3/4 brain damage per grandma;devel encephalopathy & hydrocephalus per MD;			Y		Y	82		Y	N	10/27/1995	10/31/1995	4	CT & MRI head - severe white matter disease & hydrocephalus;	PVT	OTH		URI, d; fever	premature at 6 mo gestation;severe bronchopulmonary dysplasia requiring intubation/tracheostomy;hypotonia accompanying sz activity in oct 95;d,URI,fever;	~ ()~~~In patient	896052006L	1						1	Brain oedema; Coma; Delirium; Drug ineffective; Encephalopathy; Grand mal convulsion; Hydrocephalus; Infection	FLU3~PFIZER\WYETH~4958102~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0085000	03/08/1996	NH	56.0	55		F	10/11/1995	pt recv vax & subsequently devel chills & fever that day;by the following day the above rxn had resolved									Y	10/19/1994	10/19/1994	0		OTH	OTH	unk	unk	none	~ ()~~~In patient	895300009L	1						1	Chills; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0085001	03/08/1996	KS				F	10/25/1995	pt recv vax last yr & devel a raised red welt @ the inj site, which resolved in 1 or 2 days									Y					OTH	OTH	unk	unk		~ ()~~~In patient	895313021L	1						1	Injection site hypersensitivity; Urticaria	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0085002	03/08/1996	IL				U	10/20/1995	pt devel welts @ the inj site following vax;pt also exp back aches & neck pain;no further details known as of the date of this report									U					PVT	OTH	unk	unk		~ ()~~~In patient	895317009L	1						1	Back pain; Injection site hypersensitivity; Neck pain; Urticaria	FLU3~PFIZER\WYETH~4958073~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0085003	03/08/1996	TN				F	10/18/1995	pt recv vax last year & devel an inj site rxn, which started out sl, & progressed to a silver-dollar sized welt 6-8hr later;the area was reddened & tender for approx 1-2wks;no systemic rxn was noted & pt was recovered;									Y					PVT	PVT	Synthroid	unk		~ ()~~~In patient	895317010L	1						1	Unevaluable event	FLU3~PFIZER\WYETH~~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0085004	03/08/1996	TX	47.0	47		F	10/13/1995	pt recv vax last year OCT94 & devel swelling @ inj site;pt has recovered from the above rxn									Y	10/05/1994	10/05/1994	0		OTH	OTH	Premarin	none	none	~ ()~~~In patient	895319005L	1						1	Injection site oedema; Pyrexia	FLU3~PFIZER\WYETH~4948051~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0085005	03/08/1996	NY	43.0	42		M	11/09/1995	pt devel bell's palsy 5 wk p/vax;pt was treated w/pred				Y					Y	11/01/1994	12/01/1994	30		PVT	OTH	unk	NONE		~ ()~~~In patient	895331007L	1						1	Facial palsy	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0085006	03/08/1996					M	11/14/1995	pt recv vax & devel a fever which lasted 7 days & went to 101.5;pt prefers to remain anonymous & declined to provide reporter info									Y					OTH	OTH	unk	unk		pt devel fevers which began the same day of inj p/flu vax by Wyeth x 3yrs~ ()~~~In patient	895340018L	1						1	Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0083545	03/11/1996	VA	38.0	38		M	03/05/1996	lt leg pain inc end of Dec & JAN;spastic both legs 1st of FEB;9FEB96 PCP;11FEB96 ER;12FEB96 neurologist,adm to hosp x 2 days on Baclofen				Y	Y	2			U	11/17/1995	12/30/1995	43	spinal tap x 2, spinal MRI, head MRI, head CAT SCAN	PVT	PUB	NONE	NONE	NONE other than sciatica lt leg x 10yrs;	NONE~ ()~~~In patient		1						1	Hypertonia; Pain	FLU3~PFIZER\WYETH~4958091~5~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~LEDERLE LABORATORIES~427752~6~IM~~TD ADSORBED (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0083553	03/11/1996	GA	82.0	82		F	11/01/1995	deceased 28OCT95	Y	10/29/1995							N	10/27/1995	10/29/1995	2		PUB	PUB			arhtritis	~ ()~~~In patient	GA96001	1						1	Apnoea; Cardiac arrest; Myocardial infarction	FLU3~PFIZER\WYETH~4958139~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0083555	03/11/1996	TX	55.0	55		F	02/15/1996	pt recvd vax 26OCT95-numbness & tingling of fingers & feet started on 13NOV95 progressed to paralysis on 20NOV95;no hx of viral infect;GBS					Y				Y	10/26/1995	11/13/1995	18		OTH	PUB	Premarin, Tetracycline	NONE	roseola, menopause	NONE~ ()~~~In patient	TX96031	1						1	Guillain-Barre syndrome; Hypoaesthesia; Paraesthesia; Paralysis	FLU3~CONNAUGHT LABORATORIES~5F61167~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0083589	03/11/1996	NY	52.0	52		M	02/27/1996	pt recvd vax; pain in arm, severe HA's for 4 days;									Y	10/31/1995	10/31/1995	0	na	PUB	PUB		none	none	~ ()~~~In patient	BA96K004	1						1	Headache; Pain	FLU3~CONNAUGHT LABORATORIES~5F61014~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0083619	03/12/1996	MN	39.0	39		F	03/04/1996	7 1/2 hrs p/vax numbness in lips on lt side;progressed to numbness & tingling in entire lt side of body;pain in lt ear,weakness on entire lt side;effected vision on lt side;2 sz,effected speech & walking ability,muscle control				Y				Y	N	10/18/1995	10/18/1995	0	blood tests, MRI, spinal tap etc	PVT	OTH	NA	NONE	asthma	~ ()~~~In patient		1						1	Convulsion; Ear pain; Gait disturbance; Myasthenic syndrome; Paraesthesia; Paraesthesia oral; Speech disorder; Visual disturbance	FLU3~CONNAUGHT LABORATORIES~5F61123~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1541A~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0083648	03/13/1996	TX				M	03/07/1995	pt recvd vax; devel brachial plexus neuropathy;								Y	U				no relevant data	OTH	OTH				~ ()~~~In patient	WAES96021959	1						1	Neuropathy	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0083683	03/15/1996	CO	38.0	38		F	02/28/1996	pt recv vax 24OCT95 & the next day devel neck pain,fatigue,nausea & dizziness;also had mid-epigastric pain for which pt was hospitalized x 2 days;dx was fibromyalgia;pt states still feels ill,attributes sx to vax;					Y	2			N	10/24/1995	10/25/1995	1		PVT	PVT	Mantoux inject intradermal	unk		~ ()~~~In patient	896065009L	1						1	Abdominal pain; Asthenia; Dizziness; Hepatic function abnormal; Malaise; Myalgia; Nausea; Neck pain	FLU3~PFIZER\WYETH~4958077~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0083684	03/15/1996	CA	73.0	73		M	02/29/1996	pt recv vax & 1wk later devel weakness & pain in the lt arm;weakness progressed to lt leg;pt also had edema in the lateral arm & shoulder which resulted in a frozen shoulder;pt was admitted to neurology service,all test were non-diagnostic				Y	Y				N	02/01/1996	02/08/1996	7		PUB	PUB	unk	unk	pt had a history of gout	~ ()~~~In patient	896064020L	1						1	Hypokinesia; Myasthenic syndrome; Oedema peripheral; Pain	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0083711	03/15/1996	WA	43.0	43		M	02/12/1996	12FEB96 c/o prolonged pain rt arm since flu shot 30OCT95;able to use arm-exam by MD told to exercise-has been using weight;had ?sz 23NOV;was working in yard woke up on the ground;taken to ER-told may have sz d/t exhaustion on no med;									Y	10/30/1995	10/30/1995	0		PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	WA961212	1						1	Convulsion; Hypertonia; Injection site pain; Pain; Syncope	FLU3~PFIZER\WYETH~495812~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0080003	03/19/1996	TX	54.0	54		M	03/15/1996	sl redness @inject site;rt shoulder pain,fasciculations,numbness,tingling in ulnar distribution;dx of brachial plexitis;unable to sleep,ulnar/radial weakness rt arm;random blood sugar 200,CPK 281,TSH 12.05;rt brachial plexus neuropathy;								Y	U	10/06/1995	11/13/1995	38	serum glucose 200; serum CPK 281; TSH 12.05; ESR 8; CBC nl;	PVT	OTH	synthroid; micronase; glucophage; optipranolol; prozac;		NIDDM;glaucoma;hypothyroidism;neuralgia,trigeminal;depression;granuloma;allergy pcn;	~ ()~~~In patient	WAES96011471	1						3	Hypertonia; Hypokinesia; Injection site hypersensitivity; Muscle twitching; Neuritis; Neuropathy; Pain; Paraesthesia; Hypertension; Hypokinesia; Injection site hypersensitivity; Insomnia; Laboratory test abnormal; Myasthenic syndrome; Neuropathy; Paraesthesia; Hormone level abnormal; Hyperglycaemia; Injection site hypersensitivity; Laboratory test abnormal; Myalgia; Myasthenic syndrome; Neuropathy	FLU3~PARKE-DAVIS~00975P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~MERCK & CO. INC.~~1~~RA~PNEUMO (PNEUMOVAX)~2|FLU3~PARKE-DAVIS~00975P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~3|PPV~MERCK & CO. INC.~~1~~~PNEUMO (PNEUMOVAX)~3|FLU3~PARKE-DAVIS~00975P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~4|PPV~MERCK & CO. INC.~~UNK~IM~RA~PNEUMO (PNEUMOVAX)~4	USA	Disabling	Influenza
0083212	03/19/1996	KY				U	03/13/1996	an unborn,24 wk fetus was dx w/fetal anomaly p/mom recv flu vax 9NOV95;6FEB96 mom had an ultrasound that showed the fetus missing the lt hand;mom recv vax 6wk into pregnancy;pregnancy was not terminated;										11/09/1995	02/06/1996	89	NONE	PVT	OTH	unk	unk	unk	~ ()~~~In patient	0010150960015	1						2	Foetal disorder; Congenital anomaly; Foetal disorder	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0083783	03/20/1996	WI	71.0	71		F	03/12/1996	devel vomiting & severe diarrhea on 31OCT95;began to have diff standing & the sensation of wanting to jump out of skin;condition cont to worsen & pt seen by MD 21, 23 & 24NOV;24NOV pt was unable to stand & was adm to hosp;dx GBS			Y		Y	30			N	10/13/1995	11/24/1995	42	MRI, spinal tap	OTH	PVT	NONE	NA	history of stomach ulcers	~ ()~~~In patient		1						1	Asthenia; Coordination abnormal; Guillain-Barre syndrome; Hypokinesia; Nervousness; Pain; Visual disturbance; Weight decreased	FLU3~PFIZER\WYETH~4958124~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0083827	03/22/1996	MI	9.0	9		F	11/03/1995	pt c/o pain @ inj site which radiates down underside of arm & into armpit;on a scale of 1-10 pain is a 7;mom reports there is a 1 cong horizontal bruise across inj site;pt c/o frontal h/a also				Y					Y	11/01/1995	11/01/1995	0		PUB	UNK	Vanceril inhaler;allergy shots every other	NONE	mold leaves trees ragweed	~ ()~~~In patient	MI96018	1						1	Ecchymosis; Headache; Injection site pain; Pain	FLU3~PFIZER\WYETH~4958123~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0083841	03/25/1996	OH	77.0	77		F	03/25/1996	pt exp tiredness, fatigue, arched all over, delirious, acted oddly @ times & hallucinations few days p/vax;pt was belligerent to melancholy;pt failed to be aware of surroundings;poss vascular problem assoc w/senile dementia &/or psychoses					Y				N	07/01/1995	07/11/1995	10	NONE	OTH	OTH	Ativan, Vasotec;Calan	NONE	HTN, stage II	~ ()~~~In patient	ALI96010C	1						1	Asthenia; Cardiovascular disorder; Delirium; Depression; Hallucination; Myalgia; Personality disorder; Stupor	FLU3~MEDEVA PHARMA, LTD.~E7765HD~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0083852	03/25/1996	FL	1.0	1	.0	F	03/19/1996	high temp 103.8; mild rash-that turned into rash that covered entire body, coughing-glassy eyed look				Y					Y	03/07/1996	03/15/1996	8	mild case of measles dx	PUB	OTH	APAP	NONE	NONE	NA~ ()~~~In patient		1						1	Cough; Drug ineffective; Infection; Pyrexia; Rash; Stupor	FLUX~UNKNOWN MANUFACTURER~~4~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~4~~~HEP B (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~4~~~HIB (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~1~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|OPV~UNKNOWN MANUFACTURER~~4~PO~MO~POLIO VIRUS, ORAL (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0083855	03/25/1996	FL	69.0	69		M	03/25/1996	pt participated in flu vax program & later exp GBS per pt's lawyer;									U	11/23/1993	11/25/1993	2	NONE	OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	ALI96114	1						1	Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~E2253HA~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0083866	03/25/1996	OH	61.0	61		M	11/03/1995	pt recvd vax 30OCT95 11AM & 31OCT AM devel hives around head, shoulders & hands, t99, severe itching, felt ill, h/a, fatigue, weakness, some joint pain, SOB, wheezing;1NOV saw MD;3NOV weakness, lethargy;bronchitis				Y						10/30/1995	10/30/1995	0	NONE	PUB	PUB	Propulsid, relafen, calm's forte, deseril, zocor, genesana, vasotec, sorbitralc, vit c, carlic, calcium	s/p MI, inc cholesterol, inc BP	allergy to PCN & sulfa	~ ()~~~In patient	OH96028	1						1	Arthralgia; Asthma; Bronchitis; Dyspnoea; Headache; Malaise; Pyrexia; Urticaria	FLU3~PFIZER\WYETH~4958137~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0083880	03/25/1996	NC	60.0	60		F	03/18/1996	upon awakening had diff walking legs & hips stiff & sore; duration cont-now over entire body has seen pvt MD; no numbness, or tingling-feels weak;				Y					U	11/15/1995	11/19/1995	4	bone density, full bone scan of body-sed rate, rheu factor, lytes	OTH	OTH	Premarin	NONE	NONE	~ ()~~~In patient		1						1	Arthralgia; Arthropathy; Asthenia; Back pain; Hypokinesia; Myalgia; Osteoarthritis	FLU3~PFIZER\WYETH~4958099~4~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0085212	03/25/1996	NM	50.0			F	02/28/1996	pt recv vax;exp liver enzymes,a petechial rash,& a high fever;rash&high fever occurred twice over a 2 wk,period&have resolved;													ALKPH 179 U/L; SGOT = 40 U/L; SGPT = 117; GGT= 212 U/L;	MIL	MIL	PPD;				960025741	1						1	Alanine aminotransferase increased; Aspartate aminotransferase increased; Blood alkaline phosphatase increased; Hepatic function abnormal; Petechiae; Pyrexia	DT~UNKNOWN MANUFACTURER~~1~~~DT ADSORBED (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~SMITHKLINE BEECHAM~~1~~~HEP A (HAVRIX)~1|TYP~UNKNOWN MANUFACTURER~~1~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0080683	03/26/1996	NY	60.0	60		F	12/03/1995	nausea,vomiting,h/a;APAP & rest;sx lasted 2-3 days & pt fully recovered;			Y						Y	11/27/1995	11/28/1995	1	NONE	OTH	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient		1						2	Headache; Nausea; Vomiting; Headache; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~5F61014~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening	Influenza
0084038	03/27/1996	LA	73.0	72		F	03/19/1996	pt recvd vax;feeling stiffness, low grade T,noc sweats, arm & shoulder hurt until could not get out of bed or bath tub;saw rheumatologist & given pred;				Y					N	11/20/1995	12/26/1995	36	x-rays, bone scan, blood work;	PUB	UNK	none	none	none	none~ ()~~~In patient		1						1	Arthralgia; Hyperhidrosis; Hypertonia; Hypokinesia; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0072964	04/01/1996	MN	34.0	34		M	11/18/1994	pt recv vax;exp dull achy pain in shoulder joint;6 hrs later,noticed dec range of motion which limited use of arm;significant, severe pain; saw orthopedic & dx of frozen joint;MD prescribed non-steroidal anti-inflammatory therapy;				Y					N	10/11/1994	10/11/1994	0		PUB	PVT			none	~ ()~~~In patient	894332005S	1						2	Arthralgia; Arthropathy; Hypokinesia; Pain; Arthralgia; Arthropathy; Hypokinesia; Injury; Pain	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|TD~PFIZER\WYETH~~UNK~IM~~TD ADSORBED (NO BRAND NAME)~2|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~3|TD~CONNAUGHT LABORATORIES~~UNK~IM~~TD ADSORBED (NO BRAND NAME)~3	USA	Emergency room visit	Influenza
0084306	04/02/1996	CO	21.0	21		M	03/27/1996	myalgias,h/a,abd pain,site inflamed;tx motrin,APAP,IV NaCl;				Y	Y	1			Y	03/20/1996	03/20/1996	0		MIL	MIL	NONE	NONE	NONE	~ ()~~~In patient		1						1	Abdominal pain; Headache; Injection site inflammation; Myalgia	FLU3~CONNAUGHT LABORATORIES~5J61034~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~PFIZER\WYETH~4958217~UNK~SC A~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|YF~CONNAUGHT LABORATORIES~5M61121~UNK~SC A~~YELLOW FEVER (YF-VAX)~1	USA	Hospitalisation	Influenza
0084307	04/02/1996	CO	19.0	18		M	03/27/1996	myalgias,h/a,nausea,dizzy,shakes,near syncope episode,blurred vision,hands numb,t100.3;tx motrin,IV naCl,heparin lock				Y	Y	1			Y	03/20/1996	03/20/1996	0		MIL	MIL	NONE	NONE	NONE	~ ()~~~In patient		1						1	Amblyopia; Headache; Myalgia; Nausea; Paraesthesia; Pyrexia; Syncope; Tremor	FLU3~CONNAUGHT LABORATORIES~5J61034~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|OPV~PFIZER\WYETH~724F4~UNK~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~1|TYP~PFIZER\WYETH~4958217~UNK~SC A~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|YF~CONNAUGHT LABORATORIES~5M61121~UNK~SC A~~YELLOW FEVER (YF-VAX)~1	USA	Hospitalisation	Influenza
0084309	04/02/1996	CO	20.0	20		M	03/27/1996	h/a, nausea, shaking				Y	Y	1			Y	03/20/1996	03/20/1996	0		MIL	MIL	NONE	NONE	NONE	~ ()~~~In patient		1						1	Headache; Nausea; Tremor	FLU3~CONNAUGHT LABORATORIES~5J61034~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|OPV~PFIZER\WYETH~724F4~UNK~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~1|YF~CONNAUGHT LABORATORIES~5M61121~UNK~SC A~~YELLOW FEVER (YF-VAX)~1	USA	Hospitalisation	Influenza
0084326	04/02/1996	MN	65.0	65		M	02/20/1996	started feeling ill 2-3 wk p/vax;exp h/a,fever,pale,chills,fatigue,red eyes,sudden onset of ecchymotic areas on legs,dx w/wegener's granulomatosis mid JAN;recv chemotherapy,kidney dialysis,gravely ill			Y		Y	24	Y		U	11/02/1995	12/15/1995	43	multiple studies/tests	PUB	PUB	NONE	NONE	No known allergies	NONE~ ()~~~In patient	MN96007	1						1	Arrhythmia; Asthenia; Ecchymosis; Gastric ulcer; Granuloma; Pyrexia; Renal failure acute; Right ventricular failure	FLU3~PFIZER\WYETH~4958141~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~4L61153~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0084327	04/02/1996	MO	54.0	54		F	11/01/1995	GBS,muscle weakness & spasms insulin dependent diabetes (caused from medication given for GBS);muscle relaxants,physical therapy,pain med,antihypertensive,insulin,nerve medication;left w/nerve & muscle damage to legs & side				Y	Y	7		Y	N	10/02/1989	10/08/1989	6		PVT	OTH	Zestril, Calan, Zantac & hydrochlorothiazide	NONE	HTN	~ ()~~~In patient		1						1	Diabetes mellitus; Guillain-Barre syndrome; Hypertonia; Hypokinesia; Myasthenic syndrome; Nail disorder; Neuropathy; Pain	FLU3~PARKE-DAVIS~01209P~2~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation,Disabling	Influenza
0084332	04/02/1996	MN	37.0	37		F	01/03/1996	has fever, felt achy, heart racing felt couldn't drive home;went to urgent care where was given APAP & DPH									Y	10/24/1995	10/24/1995	0	NONE	OTH	OTH	NONE	NONE	mitral valve prolapse/pernicious anemia	NONE~ ()~~~In patient	MN95036	1						1	Myalgia; Pyrexia; Tachycardia	FLU3~CONNAUGHT LABORATORIES~5F61126~2~IM L~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0084337	04/02/1996	MN	38.0	38		F	03/05/1996	5NOV lt shoulder pain,10NOV lt arm & lt hand weak w/tingling of 4th & 5th fingers;11NOV rt arm & rt hand weak & tingling;18NOV legs shaky & didn't feel right & lt side of face tingling;saw internist;1 or 2 2ks later saw neurologist;CTS				Y					N	10/23/1995	11/05/1995	13	MRI of neck=osteoarthritis; EMG-nl x/for bilat carpal tunnel;brain scan-nl; thyroid studies nl; mercury level nl; lyme disease neg;	OTH	OTH	NONE	NONE	myasthenia gravis	pt exp diarrhea, chills, muscle aches, fever @ 36hrs w/flu vax dose 9~ ()~~~In patient	MN96008	1						1	Arthritis; Asthenia; Myasthenic syndrome; Myopathy; Pain; Paraesthesia; Tenosynovitis; Tremor	FLUX~UNKNOWN MANUFACTURER~~7+~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0084476	04/04/1996	GA	63.0	62		F	01/17/1996	next day leg aches, h/a, vomiting, fever, 1 1/2 wk later cough, congestion then h/a & fever returned;went to ER 30DEC95;rx w/Zithromax;sneezing, leg aches, cough, sore arm @ inj site, swollen & black now still bump there;				Y					N	11/27/1995	11/29/1995	2	only seen in ER	PUB	PUB		NONE		~ ()~~~In patient	GA96023	1						1	Cough; Headache; Injection site mass; Injection site oedema; Injection site pain; Lung disorder; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4958107~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0084671	04/09/1996	MI	48.0	48		F	03/25/1996	w/in 3 days of vax pt devel lt upper jaw pain & w/in 5 days became SOB (pt thought might be having MI);also devel abd distention,constipation/diarrhea;ER r/o sinusitis,hepatitis,bowel obstruction;echocardiogram done 2JAN96;fever				Y	Y		Y		U	12/06/1995	12/08/1995	2	19DEC95 LFT's doubled;2JAN96 echocardiogram revealed massive pericardial effusion w/cardiac tamponade	OTH	OTH	NONE	99 temp & some hoarseness;	hx of pericardial effusion 1981	NONE~ ()~~~In patient		1						1	Abdominal distension; Constipation; Diarrhoea; Dyspnoea; Hepatic function abnormal; Pain; Pericardial effusion; Pyrexia	FLU3~PFIZER\WYETH~4958147~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0084678	04/11/1996	NY	81.0	81		M	03/20/1996	pt recv vax NOV95 & 5 days later devel a fever accompanied by severe muscle pain & mental confusion;adm to hosp for w/u;WBC count was nl,but BUN was elevated;because of history of prostatitis underwent prostatoscopy;dx prostatitis;					Y	11			Y	11/01/1995	11/01/1995	0	WBC was normal, BUN was elevated;	PVT	PVT	unk	un	pt has a history of osteoarthritis & prostatitis;monoclonal gammopathy (no myeloma) was discovered in the 1980's;	~ ()~~~In patient	896082002L	1						1	Blood urea increased; Condition aggravated; Confusional state; Laboratory test abnormal; Pain; Prostatic disorder; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0084707	04/12/1996	TX	36.0	36		F	03/06/1996	pt recv vax;feverish & could not get out of bed;pt felt she had no strength on lt side;saw MD for numbness of her side,tingling in ear & throat numbness;									U	02/12/1996	02/12/1996	0	blood work done, urine tested	OTH	PUB	none	none	none	na~ ()~~~In patient	TX96046	1						1	Hypokinesia; Myasthenic syndrome; Paraesthesia; Pyrexia	FLU3~PFIZER\WYETH~4958092~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|MMR~MERCK & CO. INC.~0789B~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PPV~MERCK & CO. INC.~0962A~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~430109~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0079661	04/15/1996	PR	64.0	64		M	11/03/1995	pt recv vax;exp numbness perioral,head,arm,lt leg,difficulty standing & walking;referred to hosp;				Y					U	11/02/1995	11/02/1995	0		PUB	PUB		lupus, diabetes		~ ()~~~In patient	PR95012	1						1	Gait disturbance; Hypokinesia; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~5F61096~2~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~4H61118~2~SC~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0079662	04/15/1996	PR	53.0	53		M	10/18/1995	pt recv vax;devel minimal periorbital edema in area of rt eye lid;erythema in area of face & neck;dph given & pt was observed;				Y					Y	10/18/1995	10/18/1995	0	na	PUB	PUB			na	na~ ()~~~In patient	PR95011	1						1	Face oedema; Rash	FLU3~CONNAUGHT LABORATORIES~5F61096~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~4H61118~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0084798	04/15/1996	MA	42.0	42		F	04/09/1996	flu shot given OCT92 in rt arm;pt had intermittent pain in muscle for about 1yr;during that time rt arm, hand & shoulder deteriorated to point of diminished functioning;pt had Physical therapy & occupational therapy;lost use of arm and hand								Y	N	10/01/1992	10/01/1992	0	CT scan & MRI both of head were neg;	PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Arthralgia; Arthropathy; Extrapyramidal disorder; Hypokinesia; Myalgia; Oedema peripheral; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0084799	04/15/1996	GA				F	03/26/1996	agenesis of corpus collosum/variant of holoprocencephaly;													serum IgM7	UNK	UNK			mom has asthma (exercise induced);no prenatal care until 31st wk;uses ventoling inhaler	~ ()~~~In patient		1						1	Congenital anomaly	FLU3~PARKE-DAVIS~01285P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~390967~UNK~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0084800	04/15/1996	MI	69.0			M	01/02/1996	pt recv flu vax & dx GBS 10days post vax;devel proximal weakness in lower extremities & paresthesias in both hands & feet;unable to arise from a squat & areflexic x/for trace responses @ biceps;Romberg test was positive;					Y								Romberg test positive;EMG studies showed a mild, predominantly demyelinating polyradiculoneuropathy w/o conduction block or ongoing denervation;Cr 2.8;kidney biopsy consistent w/interstitial nephritis	UNK	UNK				~ ()~~~In patient		1						1	Guillain-Barre syndrome; Hypokinesia; Myasthenic syndrome; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0084973	04/17/1996	CO	44.0			F	04/06/1996	w/in 4hr p/shot pt began to feel off & squeamish;by 8hrs p/shot pt was vomiting repeatedly & forcefully;had to go to ER:				Y					Y	10/18/1995	10/18/1995	0		PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Depersonalisation; Malaise; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0085029	04/22/1996	MS	46.0	46		F	11/20/1995	pt recv vax 21SEP95 & devel rash on groin & stomach;22SEP MD changed Verelan to Cardizem pt awakened 23SEP w/h/a,swollen tongue,conjunctivitis,pt to ER -near syncope			Y		Y					09/21/1995	09/22/1995	1	NONE	UNK	UNK	Atarax, Premarin, Maxzide, Cardizem Cd, Verelan		25SEP pt w/less erythema, no new lesions, less irritation to eyes,	~ ()~~~In patient		1						1	Conjunctivitis; Headache; Rash; Syncope; Tongue oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0085052	04/22/1996	PA	73.0	72		F	04/16/1996	pt states has lost 1/2 of hair & dermatologist states pt has teloza effusion;pt reports slow healing;				Y					N	10/31/1995	11/03/1995	3		PVT	PVT				~ ()~~~In patient		1						1	Alopecia; Dermatitis exfoliative; Impaired healing; Influenza; Lichenoid keratosis; Myalgia; Pharyngitis; Psoriasis	FLU3~PFIZER\WYETH~5F61145~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0085100	04/23/1996	HI	52.0	52		F	10/25/1995	devel tissue swelling,pain & hardness immed p/inj;site 6 diameter;sx stopped p/5 days				Y					Y	10/18/1995	10/18/1995	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	HI9604	1						1	Injection site mass; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~5F61162~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0085101	04/23/1996	HI	49.0	49		F	10/19/1995	2hr 30min p/vax pt devel tissue swelling 4 diameter from inj site w/extreme pain;sx diminished p/2 days				Y					Y	10/19/1995	10/19/1995	0		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	HI9605	1						1	Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~5F61162~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0085239	04/24/1996	CA	78.0	77		F	10/30/1995	pt recv vax 23OCT95 915AM & by 3PM inject site itching;24OCT95 rash all over body & itching;saw PMD;25OCT95 rash/itching abd/back went to PMD had cortisone inj & topical to rash				Y					Y	10/23/1995	10/23/1995	0		PUB	PUB	Topral, Alllalotec;Synthroid;Unidcon, Nasolide	NONE	dust, pollen/food allergies denies egg allergy/hypothyroid;allerg to morphine & PCN inj	~ ()~~~In patient	CA960029	1						1	Pruritus; Rash	FLU3~PFIZER\WYETH~4958151~6~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0085292	04/25/1996	MA	80.0	80		M	04/05/1996	pt recv vax & started to notice a funny feeling & numbness that started in lt leg & progressed to rt leg;pt exp bilat leg weakness & was having diff walking;MD felt d/t rxn to flu shot;dx GBS & hosp;had extensive testing & underwent plasma				Y	Y	4		Y	N	10/18/1995	11/14/1995	27	dx paraproteinemic demyelination neuroapthy;	PUB	PUB	Digoxin;ASA	NONE	had hernia operation 31OCT95, rx for arrhythmia w/digoxin	NONE~ ()~~~In patient	MA9607	1						1	Guillain-Barre syndrome; Hypokinesia; Laboratory test abnormal; Myasthenic syndrome; Neuropathy; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~5F61134~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0085300	04/25/1996	IL	31.0	31		M	11/03/1995	pt recv vax 4OCT95 & next day had dulled hearing in lt ear & an audiogram demonstrated a dec in low threshold hearing in that ear;has a nl otoscopic exam & MRI;									N	10/04/1995	10/05/1995	1	13OCT95 mild hearing loss of 250hz (35dB threshold); 31OCT95 mild/moderate hearing loss @ 250 hz (54dB) & 500 HZ (40 dB); 12NOV95 ECOG study-nl	UNK	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						1	Deafness	FLU3~CONNAUGHT LABORATORIES~5F61133~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~SMITHKLINE BEECHAM~VHA433A6~UNK~~~HEP A (HAVRIX)~1|TYP~PFIZER\WYETH~4948133~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|YF~CONNAUGHT LABORATORIES~5F61061~UNK~~~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0085375	04/29/1996	MA	42.0	42		F	04/06/1996	hurt @ site of inj,pain of&on from 1st day to present;rt arm felt like it atrophied,was unaware of extent until tried to type;had physical therapy&occupational therapy;felt some results-did not cont,financial problems;								Y	N	11/17/1992	11/17/1992	0	x-ray of rt arm; MRI & CAT scan of brain	OTH	PUB	uses inhaler PRN	NONE	asthma-allergic to dogs & cats	NONE~ ()~~~In patient		1						1	Hypokinesia; Injection site pain; Muscle atrophy	FLU3~CONNAUGHT LABORATORIES~4928266~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0085626	05/07/1996	IL	39.0	39		M	05/01/1996	pt recv vax 26APR fever, chills, h/a, cont w/sweating & low energy level;				Y					N	04/26/1996	04/26/1996	0	low chol; blood tests somewhat nl	UNK	UNK	NONE	NONE	allergies & hayfever	pt devel h/a, chills, fever, sweating w/ dose 1 of TD/flu/polio~ ()~~~In patient		1						1	Asthenia; Chills; Headache; Hyperhidrosis; Hypocholesterolaemia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|OPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, ORAL (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0085646	05/07/1996	OH	28.0	28		F	03/06/1996	pt presented to emergency dept 1hr p/vax;pt exp hives lt side of face & swelling in throat;no local redness or rash on rt arm				Y					Y	10/20/1995	10/20/1995	0	t99.2;pulse 72;resp 18;BP 120/70	OTH	OTH				~ ()~~~In patient		1						1	Laryngospasm; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0085659	05/08/1996	TN	52.0	52		F	11/14/1995	couple of days p/vax began itching lt eye & rt hand, next day hives on bridge of nose, both hands, had whelps, both eyes became red & swollen, swollen lips, whelps on ankles-some areas improved others keep cropping up									Y	11/09/1995	11/11/1995	2		PUB	PUB	for high BP		allergic to PCN, sulfa, erythromycin, molds, pollen, house dust	~ ()~~~In patient	TN96041	1						1	Conjunctivitis; Face oedema; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~5F61126~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0085883	05/10/1996	TN	61.0	61		U		GBS w/pain,imbalance,areflexia,mild quadriparalysis,onset 3DEC95;tx w/plasmapheresis;pt has improved			Y						N	11/20/1995	12/03/1995	13	EMG/NCI & spinal tap-GBS	OTH	OTH		NONE		~ ()~~~In patient		1						1	Coordination abnormal; Guillain-Barre syndrome; Hyporeflexia; Pain; Paralysis	FLUX~UNKNOWN MANUFACTURER~4958069~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0058408	05/13/1996	VA				F	12/13/1995	pt recv vax 9NOV93&w/in 9 days began to exhibit sx of nervousness;w/in 30 days or vax dx w/GBS;pt was hosp;pt will be permanently disabled;MD determined that GBS was a result of fluogen vax;no hx of GBS;					Y			Y	N	11/09/1993	11/18/1993	9	unk	OTH	OTH			no hx of GBS or any condition or environmental circumstances which would subject pt to contract GBS;	~ ()~~~In patient	0010150950289	1						2	Guillain-Barre syndrome; Nervousness	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Hospitalisation,Disabling	Influenza
0074894	05/13/1996	TX				F	06/05/1995	pt recv vax 17OCT94 & w/in 24hr devel a viral synd w/fever, achiness & severe chills;also exp vision problems & has been dx w/bilat ischemic optic neuropathy;vision dec to 20/400 in rt eye & 20/40 in lt eye;									U	10/17/1994	10/18/1994	1	unk	UNK	UNK				~ ()~~~In patient	0010150950199	1						2	Chills; Myalgia; Optic neuritis; Pyrexia; Visual disturbance	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0086041	05/13/1996	MI				U	06/02/1994	pt exp an unspecified rxn;									U					UNK	UNK				~ ()~~~In patient	0010150950002	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086042	05/13/1996	OR				U	10/27/1994	pt recv vax & approx 1hr p/vax pt exp erythema & swelling @ inj site;This is 1 of 3 patients, who exp same rxn w/the same lot#									U	10/21/1994	10/21/1994	0		UNK	UNK				~ ()~~~In patient	0010150950157	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PARKE-DAVIS~00274P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086044	05/13/1996	SC	65.0			F	10/18/1995	pt recv vax 12SEP95 & 13SEP95 presented to MD because inj site in lt arm had become reddened, swollen, hot & painful;prescribed meds;				Y					Y	09/12/1995	09/13/1995	1	unk	PVT	OTH	Estrace		chronic obstructive pulmonary disease-bronchospasm;paroxysmal atrial fibrillation	~ ()~~~In patient	0010150950202	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PARKE-DAVIS~02065P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0086045	05/13/1996	WV	33.0			F	09/18/1995	pt recv vax SEP95&devel a hard lump @ inj site;pt eval by NP&no tx was ordered;hx of allergies&takes Beconase spray&Seldane;				Y					U	09/01/1995	09/01/1995	0	unk	PUB	OTH	Beconase spray, seldane		allergies	~ ()~~~In patient	0010150950203	1						1	Injection site mass	FLU3~PARKE-DAVIS~00785P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0086046	05/13/1996	WV				F	09/18/1995	pt recv vax SEP95 & devel a hard lump @ the inj site;									U	09/01/1995	09/01/1995	0	unk	PUB	OTH			unk	~ ()~~~In patient	0010150950204	1						1	Injection site mass	FLU3~PARKE-DAVIS~00785P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086047	05/13/1996	WV	45.0			F	09/18/1995	pt recv vax SEP95&devel a hard lump @ the inj site;hx of sz disorder&a thyroid problem;takes Dilantin,Phenobarb,synthroid;									U	09/01/1995	09/01/1995	0	unk	PUB	OTH	Dilantin,Phenobarb, Synthroid		sz disorder & thyroid problem	~ ()~~~In patient	0010150950205	1						1	Injection site mass	FLU3~PARKE-DAVIS~00785P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086048	05/13/1996	WV	46.0			F	09/18/1995	pt recv vax in SEP95 & devel a hard lump @ inj site;									U	09/01/1995	09/01/1995	0	unk	PUB	OTH			NONE	~ ()~~~In patient	0010150950206	1						1	Injection site mass	FLU3~PARKE-DAVIS~00785P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086049	05/13/1996	WV				U	09/18/1995	pt recv vax SEP95 & devel a hard lump @ the in site;									U	09/01/1995	09/01/1995	0	unk	PUB	OTH			unk	~ ()~~~In patient	0010150950207	1						1	Injection site mass	FLU3~PARKE-DAVIS~00785P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086050	05/13/1996	MI	45.0			F	09/18/1995	pt recv vax 28AUG95 & 5SEP95 devel nausea, vomiting, & t102-103 x3 days;also exp gen aching & a cough;cough worsened as the wk progressed;pt seen @ clinic & placed on Bactrim;				Y					N	08/28/1995	09/05/1995	8	NONE	OTH	PUB			influenza FEB95/hayfever	~ ()~~~In patient	0010150950208	1						1	Cough; Drug ineffective; Myalgia; Nausea; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~02165P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0086051	05/13/1996	NJ	65.0	65		F	11/21/1995	pt recv vax OCT94&feb95 devel psoriasis of scalp&exp loss of hair;MD prescribed cream w/cortisone&vit A;pt referred to dermatologist who prescribed another cream;fungal cult neg;psoriasis resolved&hair growing back				Y					Y	10/01/1994	02/01/1995	123	FEB95 thyroid test nl;fungal cult neg;	PUB	OTH	vitamins		NONE	~ ()~~~In patient	0010150950210	1						1	Alopecia; Hair disorder; Psoriasis	FLU3~PARKE-DAVIS~00194P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0086052	05/13/1996	NJ	67.0	67		M	12/19/1995	pt recv vax OCT94 & NOV94 devel psoriasis of the scalp & exp loss of hair;tx w/hydrocortisone cream;events resolved p/4months;				Y					Y	10/01/1994	11/01/1994	31	NONE	PUB	OTH	vitamins		heart murmur	~ ()~~~In patient	0010150950211	1						1	Alopecia; Hair disorder; Psoriasis	FLU3~PARKE-DAVIS~00194P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0086053	05/13/1996	CA	30.0	30		F	10/19/1995	pt recv vax 9OCT95&devel nausea,vomiting&diarrhea p/inj;pt recovered;the suspect medication was left unrefrigerated overnoc;									Y	10/09/1995			unk	PVT	OTH			unk	~ ()~~~In patient	0010150950215	1						1	Diarrhoea; Nausea; Vomiting	FLU3~PARKE-DAVIS~00575P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086054	05/13/1996	CO	42.0	42		F	12/13/1995	pt recv vax 18OCT95 & w/in a few hr post vax pt devel achy joints, followed by fever & itchy skin, w/o rash;									U	10/18/1995	10/18/1995	0	unk	PVT	OTH	proventil inhaler, biaxin, claritin		mild asthma	~ ()~~~In patient	0010150950216	1						1	Arthralgia; Pruritus; Pyrexia	FLU3~PARKE-DAVIS~01564P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086055	05/13/1996	OH				F	10/20/1995	pt recv vax OCT94 & 1 or 2 days p/vax pt devel pain in shoulder joint;required MD visits & physical therapy;pt recovered;				Y					Y	10/01/1994	10/01/1994	0	unk	OTH	OTH			unk	~ ()~~~In patient	0010150950217	1						1	Arthralgia	FLU3~PARKE-DAVIS~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0086056	05/13/1996	OH				F	10/20/1995	pt recv vax 10OCT95 & 11OCT95 pt noticed that the inj site had a red, raised, tender, & itchy area;s/s have resolved;									Y	10/10/1995	10/11/1995	1	NONE	OTH	OTH			NONE	~ ()~~~In patient	0010150950218	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus	FLU3~PARKE-DAVIS~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086057	05/13/1996	MI	48.0			F	11/27/1995	pt recv vax 16OCT95&17OCT95 devel a tender&sl enlarged lt supraclavicular lymph node;pt eval by MD;pt reevaluated 24OCT95&event has resolved;				Y					Y	10/16/1995	10/17/1995	1	NONE	OTH	OTH	sinus med		allerg to shellfish, nuts, dust, pollen, & pet dog	~ ()~~~In patient	0010150950219	1						1	Lymphadenopathy; Pain	FLU3~PARKE-DAVIS~00885P~6~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0086058	05/13/1996	CA	35.0	35		F	10/25/1995	pt recv vax 16OCT95 & that evening devel a sore throat & fever;w/in 48hr devel laryngitis, chills & congestion;fever & chills have subsided;other sx are subsiding;									N	10/16/1995	10/16/1995	0	NONE	OTH	OTH	NONE		NONE	~ ()~~~In patient	0010150950220	1						1	Chills; Drug ineffective; Laryngitis; Pharyngitis; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086059	05/13/1996	TX	78.0	78		M	01/18/1996	pt recv vax & devel redness @ inj site;no tx was necessary;pt recovered;									Y	10/09/1995			unk	OTH	OTH	Paxil, micro K, tagamet, haldor, ferancee	unk	HTN, glaucoma, arteriosclerotic cardiovascular disease	~ ()~~~In patient	0010150950222	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086060	05/13/1996	TX	3.0	3		F	01/18/1996	pt recv vax & devel redness @ the inj site;pt recovered;									Y	10/09/1995			unk	OTH	OTH	Micro K, Relafen, Isordil, Ativan, ASA	unk	HTN, angina, myocardial infraction, cardiac arrhythmia, severs osteoarthritis, POD & anemia	~ ()~~~In patient	0010150950223	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086061	05/13/1996	TX	69.0	68		M	01/18/1996	pt recv vax OCT95 & devel redness @ the inj site;no treatment necessary;pt recovered;									Y	10/01/1995	10/01/1995	0	unk	OTH	OTH	Dyazide, Advil, Zoloft, Insulin		acute bronchitis, diabetes	~ ()~~~In patient	0010150950224	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086062	05/13/1996	TX	77.0	77		F	01/18/1996	pt recv vax OCT95 & pt devel swelling, warmth, & a large area of redness to the inj site;no tx necessary;pt has recovered;									Y	10/01/1995	10/01/1995	0	unk	OTH	OTH	insulin, zoloft, lozol, tenex		HTN, hiatal hernia, cerebral palsy, diabetes	~ ()~~~In patient	0010150950225	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086063	05/13/1996	TX	83.0	83		M	01/18/1996	pt recv vax 9OCT95 & devel redness @ inj site;no tx was necessary;pt has recovered;									Y	10/09/1995			unk	OTH	OTH	Lasix, micro K, Hytrin, Lanoxin, synthroid, haldol, quinidine gluconate		ventricular arrhythmia w/severe syncope, HTN, alzeimers	~ ()~~~In patient	0010150950226	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086064	05/13/1996	TX	81.0	81		M	01/18/1996	pt recv vax 9OCT95 & pt devel redness @ the inj site;no tx was necessary;pt recovered;									Y	10/09/1995			unk	OTH	OTH	lasix, eldepryl, micro K		organic brain synd, congestive heart failure, alcoholic cirrhosis & parkinson's disease	~ ()~~~In patient	0010150950227	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086065	05/13/1996	TX	70.0	70		M	01/18/1996	pt recv vax 9OCT95 & devel redness @ the inj site;no tx necessary;pt recovered;									Y	10/09/1995			unk	OTH	OTH	Micro K, Bumex, Dilantin, Glucotrol		mental retardation, cerebrovascular accident, HTN, diabetes, & sz disorder	~ ()~~~In patient	0010150950228	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086066	05/13/1996	TX	82.0	82		F	01/19/1996	pt recv vax 10OCT95 & devel redness @ the inj site;no tx was necessary;pt recovered;									Y	10/10/1995			unk	OTH	OTH	Sinemet, Periactin, mellaril		parkinson's disease	~ ()~~~In patient	0010150950229	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086067	05/13/1996	TX	91.0	90		F	01/19/1996	pt recv vax 10OCT95 & devel redness @ the inj site;no tx was necessary;pt recovered;									Y	10/10/1995			unk	OTH	OTH	Vasotec, Anaprox, Mandelamine, Skelaxin, Premarin		HTN, lymphoma, osteoarthritis, osteporosis	~ ()~~~In patient	0010150950230	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086068	05/13/1996	TX	85.0	85		F	01/19/1996	pt recv vax 10OCT95 & devel warmth & a large area of redness @ the inj site;no tx necessary;pt recovered;									Y	10/10/1995			unk	OTH	OTH	Digoxin, Oxybutynin, Ergoloid, Imipramine		congestive heart failure, arteriosclerosis, senility	~ ()~~~In patient	0010150950231	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086069	05/13/1996	TX	87.0	87		F	01/19/1996	pt recv vax 9OCT95 & pt devel redness @ the inj site;no tx was necessary; pt recovered;									Y	10/09/1995			unk	OTH	OTH	Insulin, Cardizem, halfprin		diabetes, parkinson's disease, congestive heart failure, arthritis, cardizem, arteriosclerotic heart disease, ischemic heart disease	~ ()~~~In patient	0010150950232	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086070	05/13/1996	TX	90.0	90		F	01/19/1996	pt recv vax 9OCT95 & devel redness @ the inj site;no tx was necessary;pt has recovered;									Y	10/09/1995			unk	OTH	OTH	synthroid, APAP w/codeine		arthritis, hypothyroidism, peripheral neuropathy, HTN, organic brain synd	~ ()~~~In patient	0010150950233	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086071	05/13/1996	TX	84.0	84		M	01/19/1996	pt recv vax OCT95 & devel redness & warmth to the inj site;no tx necessary;pt has recovered;									Y	10/01/1995			unk	OTH	OTH	Lasix, Micro K, Propulsid		mild congestive heart failure	~ ()~~~In patient	0010150950234	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086072	05/13/1996	TX	90.0	90		M	01/19/1996	pt recv vax & devel redness @ the inj site;no tx necessary;pt recovered;									Y	10/09/1995			unk	OTH	OTH	ASA, Lasix, Lanoxicaps, insulin, Cardizem, Isordil, Micro K		peripheral vascular disease, HTN, myocardial infarction, arteriosclerotic heart disease, angina, diabetes	~ ()~~~In patient	0010150950235	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086073	05/13/1996	TX	94.0	94		F	01/19/1996	pt recv vax & devel redness @ the inj site;no tx was necessary;pt recovered;									Y	10/10/1995			unk	OTH	OTH	ASA, dipyridamole, hydroxyzine, haloperidol		unk	~ ()~~~In patient	0010150950236	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086074	05/13/1996	TX	83.0	83		F	01/19/1996	pt recv vax OCT95 & devel redness & warmth to the inj site;no tx necessary;pt recovered;									Y	10/09/1995			unk	OTH	OTH	Dilantin		alzheimer's disease, dementia	~ ()~~~In patient	0010150950237	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086075	05/13/1996	TX	86.0	86		F	01/19/1996	pt recv vax 10OCT95 & devel redness @ the inj site;no tx necessary;pt recovered;									Y	10/10/1995			unk	OTH	OTH	Nitropatch, Corgard, Procardia, Lanoxin, Dyazide, aAllopurinol, ISMO KAON elixir, Oruvail		atrial fibrillation, HTN, angina, congestive heart failure, degenerative joint disease	~ ()~~~In patient	0010150950238	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086076	05/13/1996	TX	85.0	84		F	01/19/1996	pt recv vax 9OCT95 & devel redness @ the inj site;no tx necessary;pt recovered									Y	10/09/1995			unk	OTH	OTH	Norvasc, Lanoxin, Zyloprim, diabeta, mandelamine, levsinex, dipyridamole, lasix, zantac, micro K, quinamm, haldol, doxepin		CHF, HTN, diabetes, cardiomyopathy, colon cancer, osteoarthritis	~ ()~~~In patient	0010150950239	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086077	05/13/1996	TX	85.0	85		F	01/19/1996	pt recv vax & devel redness @ the inj site;no tx necessary;pt recovered;									Y	10/09/1995			unk	OTH	OTH	Lanoxicaps, procardia, nitropatch, ASA, niferex, micro K, lasix, isosorbide dinitrate, prozac		arteriosclerotic heart disease, congestive heart failure, HTN, arrhythmia	~ ()~~~In patient	0010150950240	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086078	05/13/1996	TX	75.0	75		F	01/22/1996	pt recv vax 9OCT95 & devel redness @ the inj site;no tx necessary;pt recovered;									Y	10/09/1995			unk	OTH	OTH	Procardia, Lasix, Lanoxin, Thyroid, Halfprin, Aldactone, fergon, APAP, Dramamine, Pepcid		cerebrovascular accident, CHF, transient ischemic attack, hypothyroidism, phlebitis, petechiae, microcytic anemia, labyrinthitis	~ ()~~~In patient	0010150950241	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086079	05/13/1996	TX	92.0	92		F	01/22/1996	pt recv vax 9OCT95 & devel redness @ the inj site;no tx necessary;pt recovered;									Y	10/09/1995			unk	OTH	OTH	ASA, Procardia, Lasix, Zinc, sulfate, micro K, Dilantin, DPH		cerebrovascular accident, sz disorder, HTN, essential glaucoma	~ ()~~~In patient	0010150950242	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086080	05/13/1996	TX				F	01/22/1996	pt recv vax & devel redness & warmth to the inj site;no tx necessary;pt recovered;									Y	10/01/1995	10/01/1995	0	unk	OTH	OTH	Thyroxine, Lasix, Micro K, Vasotec, Thoraxine, Imipramine		HTN, hypothyroidism, CHF, peripheral edema, cellulitis	~ ()~~~In patient	0010150950243	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086081	05/13/1996	TX	99.0			F	01/22/1996	pt recv vax 9OCT95 & devel redness & warmth to the inj site;no tx necessary;pt recovered;									Y	10/09/1995			unk	OTH	OTH	ASA, vasotec, zinc, naprosyn, simethicone		HTN, arthritis, irritable synd, peripheral vascular disease, arteriosclerotic heart disease, osteoporosis, diverticulosis	~ ()~~~In patient	0010150950244	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086082	05/13/1996	TX	58.0	58		F	01/22/1996	pt recv vax 9OCT95 & devel redness & warmth @ the inj site;no tx necessary;pt recovered;									Y	10/09/1995			unk	OTH	OTH	Dilantin, Lasix, Tegretol, Bumex, Capoten, Risperdal, micro K		cerebral palsy, epilepsy, iron deficiency anemia, HTn, female climateric state	~ ()~~~In patient	0010150950245	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086083	05/13/1996	TX	82.0	82		F	01/22/1996	pt recv vax 9OCT95 & pt devel redness & warmth @ the inj site;no tx necessary;pt recovered;									Y	10/09/1995			unk	OTH	OTH	Reglan, Lasix, Micro K, Ativan, Axid, Trental, levsinex, APAP, ambien		irritable bowel synd, peripheral vascular disease	~ ()~~~In patient	0010150950246	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086084	05/13/1996	TX	82.0	82		F	01/22/1996	pt recv vax 9OCT95 & pt devel redness @ the inj site;no tx necessary;pt recovered;									Y	10/09/1995			unk	OTH	OTH	Glucotrol, Vistaril, Insulin		diabetes, cerebellar degeneration, peripheral neuropathy	~ ()~~~In patient	0010150950247	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086085	05/13/1996	TX	88.0	88		F	01/22/1996	pt recv vax 10OCT95 & devel redness & warmth to the inj site;no tx necessary;pt recovered;									Y	10/10/1995			unk	OTH	OTH	multivitamins		borderline diabetes, frequent urinary tract infect	~ ()~~~In patient	0010150950248	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086086	05/13/1996	TX	86.0	86		F	01/22/1996	pt recv vax 9OCT95 & pt devel warmth & a pink area around the inj site;no tx necessary;pt recovered;									Y	10/09/1995			unk	OTH	OTH	Cardura, bumex, glyburide, lanoxin, zoloft, haldol, coumadin		CHF, diabetes, post cerebrovascular accident, & HTN	~ ()~~~In patient	0010150950249	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086087	05/13/1996	TX	94.0	93		F	01/22/1996	pt recv vax 9OCT95 & devel warmth & a pink area around the inj site;no tx necessary;pt recovered;									Y	10/09/1995			unk	OTH	OTH	Digoxin, mykrox, niferex, antivan, micro K, APAP		arteriosclerotic heart disease, HTN, arthritis	~ ()~~~In patient	0010150950250	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086121	05/13/1996	TX	74.0	73		F	01/22/1996	pt recv vax 9OCT95&devel warmth&a pink area around the inj site;no tx was necessary;pt has recovered;									Y	10/09/1995			UNK	OTH	OTH	Triamterene/HCTZ, dilantin, mcoro K, quinine sulfate, prozac		cerebrovascular accident	~ ()~~~In patient	0010150950251	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086122	05/13/1996	TX	81.0	81		F	01/22/1996	pt recv vax 10OCT95 & devel warmth & a pink area around the inj site;no tx was necessary;pt recovered;									Y	10/10/1995			unk	OTH	OTH	Mellaril		alzheimer's disease	~ ()~~~In patient	0010150950252	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086123	05/13/1996	TX				U	01/23/1996	pt recv vax OCT95 & devel redness, warmth, and/or soreness to the inj site;no tx necessary;pt recovered;									Y	10/01/1995			unk	OTH	OTH	unk		unk	~ ()~~~In patient	0010150950254	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086124	05/13/1996	TX				U	01/23/1996	pt recv vax OCT95 & devel redness, warmth, and/or soreness to the inj site;no tx was necessary;pt recovered;									Y	10/01/1995	10/01/1995	0	unk	OTH	OTH	unk		unk	~ ()~~~In patient	0010150950255	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086125	05/13/1996	TX				U	01/23/1996	pt recv vax OCT95 & devel redness, warmth, and/or soreness to the inj site;no rx necessary;pt recovered;									Y	10/01/1995	10/01/1995	0	unk	OTH	OTH	unk		unk	~ ()~~~In patient	0010150950256	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086126	05/13/1996	TX				U	01/23/1996	pt recv vax & devel redness, warmth, and/or soreness to the inj site;no tx was necessary;pt recovered;									Y	10/01/1995	10/01/1995	0	unk	OTH	OTH	unk		unk	~ ()~~~In patient	0010150950257	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086127	05/13/1996	TX				U	01/23/1996	pt recv vax & devel redness, warmth, &/or soreness to the inj site;no tx was necessary;pt recovered;									Y	10/01/1995	10/01/1995	0	unk	OTH	OTH	unk		unk	~ ()~~~In patient	0010150950258	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086128	05/13/1996	TX				U	01/23/1996	pt recv vax & devel redness, warmth, &/or soreness to the inj site;no tx was necessary;pt recovered;									Y	10/01/1995	10/01/1995	0	unk	OTH	OTH	unk		unk	~ ()~~~In patient	0010150950259	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086129	05/13/1996	TX				U	01/23/1996	pt recv vax & devel redness, warmth, &/or soreness to the inj site;no tx was necessary;pt recovered;									Y	10/01/1995	10/01/1995	0	unk	OTH	OTH	unk		unk	~ ()~~~In patient	0010150950260	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086130	05/13/1996	CA	55.0			F	12/04/1995	pt recv vax & devel a large local rxn the size of a softball that was hot to touch & sore, body aches, & fever a few days later;pt recovered;									Y	11/01/1995	10/31/1995		no reported	UNK	UNK	unk		pt has recv flu vax in this MD office for the last 10 yrs w/no rxn		0010150950261	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PARKE-DAVIS~00885P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086131	05/13/1996	CA	54.0			F	12/04/1995	pt recv vax 31OCT95 & pt devel body aches, malaise & itching @ the inj site;pt has recovered from these adverse events;									Y	10/31/1995	11/02/1995	2	not reported	PVT	OTH	unk		no additional medical history was reported	~ ()~~~In patient	0010150950262	1						1	Malaise; Myalgia; Pruritus	FLU3~PARKE-DAVIS~00885P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086132	05/13/1996	CA				U	11/06/1995	pt recv vax NOV95&devel body aches,& a fever a few days later;no other info is abominable;									N	11/01/1995	11/03/1995	2	not reported	PVT	OTH	unk		history is unk	~ ()~~~In patient	0010150950263	1						1	Myalgia; Pyrexia	FLU3~PARKE-DAVIS~00885P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086133	05/13/1996	CA				F	12/13/1995	pt recv vax 30OCT95 & for 24 hr pt exp body aches & fever;									Y	10/30/1995	10/30/1995	0	not reported	PVT	OTH	unk		history was not reported	~ ()~~~In patient	0010150950264	1						1	Myalgia; Pyrexia	FLU3~PARKE-DAVIS~00885P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086134	05/13/1996	CA				U	11/06/1995	pt recv vax&devel body aches,& a fever a few days later;no other info is available									N	11/01/1995	11/03/1995	2	not reported	PVT	OTH			history is unk	~ ()~~~In patient	0010150950265	1						1	Myalgia; Pyrexia	FLU3~PARKE-DAVIS~00885P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086135	05/13/1996	CA				F	12/01/1995	pt recv vax 4NOV95 & exp a large local rxn of redness & swelling @ inj site, body aches, & a h/a;pt has recovered;									Y	11/04/1995	11/04/1995	0	not reported	PVT	OTH	unk		history was not reported	~ ()~~~In patient	0010150950266	1						1	Headache; Injection site hypersensitivity; Injection site oedema; Myalgia	FLU3~PARKE-DAVIS~00885P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086136	05/13/1996	CA	47.0			F	12/13/1995	pt recv vax 21OCT95 & 23OCT95 pt became ill & c/o nausea, vomiting & chills;pt has recovered;									Y	10/21/1995	10/23/1995	2	not reported	PVT	OTH	unk		history was not reported	~ ()~~~In patient	0010150950267	1						1	Chills; Nausea; Vomiting	FLU3~PARKE-DAVIS~00885P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086137	05/13/1996	FL				U	11/08/1995	pt recv vax 18OCT95 & exp severe ache for 3 to 6 days;there was a reddened area @ the inj site the size of a quarter;									Y	10/18/1995	10/18/1995	0	None reported	PVT	PVT	unk		history is unk	~ ()~~~In patient	0010150950268	1						1	Injection site hypersensitivity; Injection site pain; Myalgia	FLU3~PARKE-DAVIS~02065P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086138	05/13/1996	FL				U	11/08/1995	pt recv vax 18OCT95 & exp severe ache for 3 to 6 days;there was a reddened area @ the inj site about the size of a quarter;									Y	10/18/1995	10/18/1995	0	none reported	PVT	PVT	unk		history is unk	~ ()~~~In patient	0010150950269	1						1	Injection site hypersensitivity; Injection site pain; Myalgia	FLU3~PARKE-DAVIS~02065P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086139	05/13/1996	FL				U	11/08/1995	pt recv vax & 18OCT95 exp severe ache for 3 to 6 days;there was a reddened area @ the inj site about the size of a quarter;									Y	10/18/1995	10/18/1995	0	None reported	PVT	PVT	unk		history is unk	~ ()~~~In patient	0010150950270	1						1	Injection site hypersensitivity; Injection site pain; Myalgia	FLU3~PARKE-DAVIS~02065P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086140	05/13/1996	FL				U	11/08/1995	pt recv vax 18OCT95 & exp severe ache for 3 to 6 days;there was a reddened area @ the inj site about the size of a quarter;									Y	10/18/1995	10/18/1995	0	none reported	PVT	PVT	unk		history is unk	~ ()~~~In patient	0010150950271	1						1	Injection site hypersensitivity; Injection site pain; Myalgia	FLU3~PARKE-DAVIS~02065P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086141	05/13/1996	FL				U	11/08/1995	pt recv vax 18OCT95&exp severe ache for 3 to 6 days;there was a reddened area @ the inj site about the size of a quarter;									Y	10/18/1995	10/18/1995	0	None reported	PVT	PVT	unk		history is unk	~ ()~~~In patient	0010150950272	1						1	Injection site hypersensitivity; Injection site pain; Myalgia	FLU3~PARKE-DAVIS~02065P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086142	05/13/1996	FL				U	11/08/1995	pt recv vax 18OCT95 & exp severe ache for 3 to 6 days;there was a reddened area @ the inj site about the size of a quarter;									Y	10/18/1995	10/18/1995	0	none reported	PVT	PVT	unk		history is unk	~ ()~~~In patient	0010150950273	1						1	Injection site hypersensitivity; Injection site pain; Myalgia	FLU3~PARKE-DAVIS~02065P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086143	05/13/1996	CO	49.0			F	12/27/1995	pt recv vax 2NOV95&3NOV95 devel a red,warm patch below the inj site&a red,itchy rash;also exp body aches,lethargy&fatigue;6NOV95 devel 10x6cm erythematous,warm to touch lesion;achy joints;ecchmotic area @ inj site;lupus like rash				Y					U	11/02/1995	11/03/1995	1	8NOV95 uric acid 2.3; C-Reactive protein 3.6; sed rate 32; arthritis profile was orederd;	OTH	OTH	paxil, Klonopin, Synthroid, premarin		arthritis/fibromyalgia/allergy to sulfa	~ ()~~~In patient	0010150950274	1						1	Arthralgia; Asthenia; Injection site hypersensitivity; Myalgia; Pruritus; Rash; Skin ulcer; Somnolence	FLU3~PARKE-DAVIS~11495P~4~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0086144	05/13/1996	NC	65.0			F	11/09/1995	pt recv vax 31OCT95 & noticed a white wheal w/surrounding redness @ inj site on 1NOV95;pt was evaluated by MD but no medical tx was initiated;pt is recovering;				Y					Y	10/31/1995	11/01/1995	1	NONE	OTH	OTH	unk		no allergies, has recvd flu shot during the prev 5yrs w/o adverse event;1994 flu vax was fluogen	~ ()~~~In patient	0010150950275	1						1	Injection site hypersensitivity; Urticaria	FLU3~PARKE-DAVIS~01395P~6~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0086145	05/13/1996	WI				F	12/19/1995	pt recv vax 28OCT95&same day c/o numbness&tingling in arm,nausea,hot flashes,& not feeling well;sc gradually lessened by the next day&pt recovered;									Y	10/28/1995	10/28/1995	0	unk	PVT	OTH			history is unk	~ ()~~~In patient	0010150950276	1						1	Malaise; Nausea; Paraesthesia; Vasodilatation	FLU3~PARKE-DAVIS~01185P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086146	05/13/1996	WI				F	12/12/1995	pt recv vax 28OCT95 & same day c/o muscle spasm approx 4 inches below inj site w/in 1 hr p/vax;the next day pt reported a rash covering chest, back & arms;pt recovered;									Y	10/28/1995	12/28/1995	61	unk	PVT	OTH			history is unk	~ ()~~~In patient	0010150950277	1						1	Hypertonia; Rash	FLU3~PARKE-DAVIS~01185P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086147	05/13/1996	WI				F	12/19/1995	pt recv vax 28OCT95&c/o scapula tingling,dizziness,numbness in elbow&severe h/a lasting approx 24hr;sx lessened by the next day&the pt recovered;									Y	10/28/1995	10/28/1995	0	unk	PVT	OTH			history is unk	~ ()~~~In patient	0010150950278	1						1	Dizziness; Headache; Paraesthesia	FLU3~PARKE-DAVIS~01185P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086148	05/13/1996	WI				F	12/19/1995	pt recv vax 28OCT95 & c/o wrist pain, numbness in little finger, fever, hot flashes, nausea, & h/a;sx lessened by the next day & pt recovered									Y	10/28/1995	10/28/1995	0	unk	PVT	OTH			history is unk	~ ()~~~In patient	0010150950279	1						1	Headache; Nausea; Pain; Paraesthesia; Pyrexia; Vasodilatation	FLU3~PARKE-DAVIS~01185P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086149	05/13/1996	WI				F	12/18/1995	pt recv vax 28OCT95 & c/o numbness & tingling in lower arm;sx gradually lessened throughout the day & the pt recovered;									Y	10/28/1995	10/28/1995	0	unk	PVT	OTH			history is unk	~ ()~~~In patient	0010150950280	1						1	Paraesthesia	FLU3~PARKE-DAVIS~01185P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086150	05/13/1996	IA	40.0	40		F	12/14/1995	pt recv vax 23OCT95 & 24OCT95 w/in 3 hr of vax pt devel nausea, vomiting, fever, diarrhea, & weakness;pt recovered;									Y	10/23/1995	10/24/1995	1	unk	PVT	OTH	NONE		NONE	~ ()~~~In patient	0010150950281	1						1	Asthenia; Diarrhoea; Nausea; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~01595P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086151	05/13/1996	IA	38.0			F	12/13/1995	pt recv vax 24OCT95 & w/in 3hr devel nausea, vomiting, stomach cramps, diarrhea;sx lasted during the noc;pt recovered;									Y	10/24/1995	10/24/1995	0	unk	PVT	OTH	NONE		NONE	~ ()~~~In patient	0010150950282	1						1	Abdominal pain; Diarrhoea; Nausea; Vomiting	FLU3~PARKE-DAVIS~01595P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086152	05/13/1996	IA	26.0			M	11/13/1995	pt recv vax 24OCT95 & 3hr later devel severe nausea, diarrhea, w/occasional vomiting;w/in a few hr became very weak & could not stay awake;sx subsided by the next morning & w/in 4 days regained full strength									Y	10/24/1995	10/24/1995	0	unk	PVT	OTH	unk		NONE	~ ()~~~In patient	0010150950283	1						1	Asthenia; Diarrhoea; Nausea; Somnolence; Vomiting	FLU3~PARKE-DAVIS~01595P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086153	05/13/1996	IA				U	11/13/1995	pt recv vax & w/in 3hr pt devel nausea, vomiting & diarrhea;									U				unk	PVT	OTH	unk		unk	~ ()~~~In patient	0010150950284	1						1	Diarrhoea; Nausea; Vomiting	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086154	05/13/1996	OH	63.0	63		M	11/29/1995	pt recv vax 25OCT95 & 30OCT95 devel double vision & paralysis of the 4th cranial nerve;tx w/pred burst & as of 27NOV95 pt sx were improved;still has a little diff w/quick focusing;									N	10/25/1995	10/30/1995	5	CT scan of head & orbits was nl;chemistry screen was all nl;	PVT	OTH			history of seasonal allergies	~ ()~~~In patient	0010150950287	1						1	Diplopia; Visual disturbance	FLU3~PARKE-DAVIS~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086155	05/13/1996	DC	32.0	32		F	11/09/1995	pt recv vax 8NOV95 & 9NOV95 devel itch @ site of inj & raised rash on lt arm & trunk;									U	11/08/1995	11/09/1995	1		OTH	OTH	unk		seasonal allergy	~ ()~~~In patient	0010150950290	1						1	Injection site hypersensitivity; Pruritus; Rash maculo-papular	FLU3~PARKE-DAVIS~00785P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086156	05/13/1996	WI				F	12/13/1995	pt recv vax 28OCT95 & devel numbness & tingling in wrist & hot flashes;sx gradually lessened throughout the day;pt recovered;									Y	10/28/1995	10/28/1995	0	none reported	PUB	OTH	unk		unk	~ ()~~~In patient	0010150950291	1						1	Hypoaesthesia; Vasodilatation	FLU3~PARKE-DAVIS~01185P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086157	05/13/1996	WI	25.0			F	01/08/1996	pt recv vax 28OCT95&exp numbness,tingling&heaviness in the same area where flu vax given;sx gradually lessened throughout the day;pt has recovered;									Y	10/28/1995	10/28/1995	0	NONE reported	PUB	OTH	unk		unk	~ ()~~~In patient	0010150950292	1						1	Asthenia; Hypoaesthesia	FLU3~PARKE-DAVIS~01185P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086158	05/13/1996	WI				F	12/13/1995	pt recv vax 28OCT95 & exp numbness & tingling in arm;sx gradually lessened throughout the day;pt recovered;									Y	10/28/1995	10/28/1995	0	none reported	PUB	OTH	unk		unk	~ ()~~~In patient	0010150950293	1						1	Hypoaesthesia	FLU3~PARKE-DAVIS~01185P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086159	05/13/1996	WI	46.0			F	01/08/1996	pt recv vax 28OCT95 & exp h/a, tingling in fingertips & not feeling well;sx gradually lessened throughout the day;pt recovered;									Y	10/28/1995	10/28/1995	0	none reported	PUB	OTH	unk		unk	~ ()~~~In patient	0010150950294	1						1	Headache; Hypoaesthesia; Malaise	FLU3~PARKE-DAVIS~01185P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086160	05/13/1996	MD	40.0			F	12/14/1995	pt recv vax & inj site became red, hot, tender, itchy & hard;pt has not yet recovered;									N		12/01/1995		none reported	OTH	OTH	unk		unk	~ ()~~~In patient	0010150950296	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Pruritus; Vasodilatation	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086161	05/13/1996	NJ	44.0			F	12/14/1995	pt recv vax 5NOV95 & exp chills, low grade fever (99) & rt sinus infect beginning 13NOV95;took Lorabid for 10 days but sx persisted for 6 wk;pt was never hosp;MD feels the sx were related to flu vax;									Y	11/07/1995	11/15/1995	8	negative blood cult	OTH	OTH	lorabid		unk	~ ()~~~In patient	0010150950297	1						1	Chills; Infection; Pyrexia; Sinusitis	FLU3~PARKE-DAVIS~00785P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086162	05/13/1996	NY	45.0			F	12/15/1995	pt recv vax 17OCT95 & exp redness & swelling @ the inj site shortly p/vax;MD was not aware of the event;									U	10/17/1995	10/17/1995	0	NONE	OTH	OTH	unk		asthma;allergies to certain foods (egg whites);possible rxn to certain meds	~ ()~~~In patient	0010150950298	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086163	05/13/1996	NJ	66.0			F	12/15/1995	pt recv vax & exp pain & redness @ the inj site;sx still persist but pt was never hosp;									U	10/10/1995	10/10/1995	0	NONE	OTH	OTH	unk		drug allergies & rxn in past	~ ()~~~In patient	0010150950299	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086164	05/13/1996	TX				U	12/18/1995	pt (exact # unk) exp local rxn such as redness, swelling, & pain @ the inj site upon receiving vax in OCT95;									U	10/01/1995	10/01/1995	0	NONE	OTH	OTH	unk		unk	~ ()~~~In patient	0010150950300	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~00475P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086165	05/13/1996	NJ	37.0	37		F		pt recv vax 27NOV95 & 28NOV95 pt noticed hives on eyelids;29NOV95 morning eyes were swollen & there was a rash on eyelids;hives also appeared on back, shoulder, & arm;MD felt rxn was poss allerg rxn;nurse felt was rxn to preservative in vax									Y	11/27/1995	11/28/1995	1	NONE	OTH	OTH	unk		unk	~ ()~~~In patient	0010150950301	1						1	Face oedema; Hypersensitivity; Pruritus; Rash; Urticaria	FLU3~PARKE-DAVIS~~3~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086166	05/13/1996	TX	30.0	30		F	12/21/1995	pt recv vax 13DEC95 & 14DEC95 pt started to exp jerking movements of arms & upper body which did not resolve while sleeping;pt had some warmth & sl swelling @ the inj site;pt was seen in ER by neuro who felt sx were anxiety related;										12/13/1995	12/13/1995	0	NONE	PUB	OTH	unk		no addtional medical history	~ ()~~~In patient	0010150950302	1						1	Anxiety; Injection site oedema; Muscle twitching; Vasodilatation	FLU3~PARKE-DAVIS~00785P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086167	05/13/1996	CA	52.0	52		F	02/08/1996	pt recv vax 4DEC95 & 6DEC95 devel an itchy allerg rxn on both upper & lower arms on the inside of wrists there was a red rash;7DEC95 eyelids & lips were swollen, red & itchy as was face;rash changed to hives;									Y	12/04/1995	12/06/1995	2	NONE reported	OTH	OTH	NONE		allergy to red wine & nail polish in early years	~ ()~~~In patient	0010150950303	1						1	Face oedema; Hypersensitivity; Pruritus; Rash; Urticaria	FLU3~PARKE-DAVIS~00195P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086168	05/13/1996	CA	19.0	19		M	02/08/1996	pt recv vax 6DEC95 & the next day devel a whole body rash, red swollen eyelids & lips & a frantic allergic itch;tx w/inj of Pred & a medrol dose pack;rash resolved into an eczema type scaly rash;itching cont for wk;									Y	12/06/1995	12/07/1995	1	NONE reported	OTH	OTH	NONE		NONE	~ ()~~~In patient	0010150950304	1						1	Eczema; Face oedema; Pruritus; Rash	FLU3~PARKE-DAVIS~00195P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086169	05/13/1996	IL	66.0	65		F	10/25/1995	pt recv vax 19OCT95 & 22OCT95 pt went to ER because the inj site was red & swollen;tx w/DPH & Ancef;sx abated by 25OCT95;				Y					Y	10/19/1995	10/22/1995	3	unk	PVT	OTH	Altace		HTN	~ ()~~~In patient	0010150960001	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PARKE-DAVIS~~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0086170	05/13/1996	NY	40.0			F	10/18/1995	pt recv vax 2OCT95 & 24hr p/vax devel h/a, fever, myalgia;				Y					N	10/02/1995	10/03/1995	1	unk	PUB	OTH	NONE	NONE	unk	~ ()~~~In patient	0010150960002	1						1	Headache; Myalgia; Pyrexia	FLU3~PARKE-DAVIS~00885P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0086171	05/13/1996	MD	20.0	19		M	11/07/1995	pt recv vax 26OCT95 & 28OCT95 devel swelling of lymph nodes @ the inj site;				Y					Y	10/26/1995	10/28/1995	2	NONE reported	PUB	OTH	NONE	NONE	allergy to Ampicillin	~ ()~~~In patient	0010150960004	1						1	Injection site oedema; Lymphadenopathy	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0086172	05/13/1996	MD				F	10/27/1995	pt recv vax & 4hr later devel hives @ the inj site, & arm felt sore & hot;pt sx resolved w/in 24hr;									Y				NONE reported	OTH	OTH	unk	unk	unk	~ ()~~~In patient	0010150960005	1						1	Injection site hypersensitivity; Injection site pain; Urticaria; Vasodilatation	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086173	05/13/1996	WA	40.0	40		F	11/03/1995	pt recv vax 3NOV95 & 1hr following vax pt exp dizziness, shaking, nausea, vomiting;pt reported sx to the MD;				Y					U	11/03/1995	11/03/1995	0	NONE reported	OTH	OTH	unk	NONE	unk	~ ()~~~In patient	0010150960006	1						1	Dizziness; Nausea; Tremor; Vomiting	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0086174	05/13/1996	NY				F	10/18/1995	pt recv vax 2OCT95 & 1hr following vax pt exp h/a, fever (temp of 103), & myalgia;pt visited the MD on 4OCT95 & was dx w/viral pneumonia;pt sx are abating slowly;				Y					N	10/02/1995	10/02/1995	0	None reported	PUB	OTH	NONE	NONE	UNK	~ ()~~~In patient	0010150960007	1						1	Headache; Infection; Myalgia; Pneumonia; Pyrexia	FLU3~PARKE-DAVIS~00885P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0086175	05/13/1996	MD	71.0	71		F	11/09/1995	pt recv vax 22OCT95 & 36hr p/vax pt devel a h/a & soreness @ the inj site;sx resolved w/in 24 to 48hr;									Y	10/22/1995	10/24/1995	2	NONE reported	OTH	OTH	Synthroid, Estrogen	NONE	multiple sclerosis	~ ()~~~In patient	0010150960008	1						1	Headache; Injection site pain	FLU3~PARKE-DAVIS~~2~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086176	05/13/1996	OH	57.0			F	01/12/1996	pt recv vax OCT95 & pt devel knee pain in one knee;pt went to ER but was never adm to the hosp;				Y					U	10/01/1995	10/01/1995	0	NONE reported	OTH	OTH	unk	unk	unk	~ ()~~~In patient	0010150960009	1						1	Pain	FLU3~PARKE-DAVIS~01085P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0086177	05/13/1996	CA				F	01/18/1996	pt recv vax NOV76 & has had & cont to have various medical conditions & illness;									N	11/01/1976			unk	OTH	OTH	unk	unk	unk	~ ()~~~In patient	0010150960010	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086178	05/13/1996	TX	83.0	83		F	01/23/1996	pt recv vax 10OCT95 & 11OCT95 pt exp nervousness, weakness, & back pain;pt recovered in 2hrs;									Y	10/10/1995	10/11/1995	1	unk	OTH	OTH	Lanoxin, Oscal, ASA, Procardia, Micro K, Lasix, Nitrobid, Capoten, Theo-dur, Ismo, dipyridamole, APAP, Brethine;		arteriosclerotic heart disease heart fialure, cerebrovascular accident, chronic obstructive pulmonary disease, anxiety	~ ()~~~In patient	0010150960011	1						1	Asthenia; Back pain; Nervousness	FLU3~PARKE-DAVIS~00195P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086179	05/13/1996	MN	43.0	43		F	03/07/1996	pt recv vax in 18NOV95&JAN96 pt donated blood through red cross;FEB96 recv notification from the red cross that blood tested positive for HTLV I;pt prev donated blood 35 times&has had no hx of positive									N	11/18/1995	01/01/1996	44	JAN96 Positive HTLV I	PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient	0010150960012	1						1	HIV test positive; Infection; Laboratory test abnormal	FLU3~PARKE-DAVIS~00675P~2~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0086180	05/13/1996	FL	71.0			M	02/22/1996	pt recv vax&devel arthralgia&myalgia in shoulders&hands;sx became progressively worse;pt was dx w/palindromic rheumatism;MD was not sure there is correlation w/the flu shot;				Y					N	11/09/1995	11/21/1995	12	NONE reported	PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient	0010150960013	1						1	Arthralgia; Myalgia; Rheumatoid arthritis	FLU3~PARKE-DAVIS~00785P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0086181	05/13/1996	PA	78.0			M	03/07/1996	pt recv vax 6SEP95&devel hives under both arms&around trunk into the groin area;the hives were characterized as itchy,hard&hurt;tx by dermatologist however condition still exists;				Y					Y	09/06/1995	09/12/1995	6	None reported	PVT	OTH	Mexitil, Zantac	unk	NONE reported	~ ()~~~In patient	0010150960014	1						1	Pain; Pruritus; Tachycardia; Urticaria; Pain; Pruritus; Skin nodule; Urticaria	FLU3~PARKE-DAVIS~~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~~1~IM~~PNEUMO (PNU-IMUNE)~1|FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0086182	05/13/1996	PA	57.0	57		F	12/27/1995	pt recv vax 16NOV95&6 days later devel intestinal cramps,followed by paresthesia,ataxia,& absent reflexes;pt was hosp in DEC95&was dx w/GBS;EMG,CT scan&LP were neg;					Y				Y	11/16/1995	11/22/1995	6	EMG neg; CT Scan neg; LP neg;	PVT	OTH	unk		NONE	~ ()~~~In patient	0010150950305	1						1	Abdominal pain; Coordination abnormal; Guillain-Barre syndrome; Hyporeflexia; Paraesthesia	FLU3~PARKE-DAVIS~02165~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0086002	05/14/1996	CA	20.0	20		M	05/06/1996	4hr post vax pt off balance,unsteadiness cont for over 4months;a few days later paresthesia in feet,climbing to legs,fatigue,soreness,palpitations got forceful;tingling in tongue,arms;h/a,pain in sides,stomach									N	12/27/1995	12/27/1995	0	all bloodwork, cardiologyl, neurology tests neg to date: stress test,  MCA, echocardiogram, electronestognogram, NCV, H reflex, head CT scan, EBV, syphillis, TB, diabetes all neg;	PVT	PVT	NONE x/ nose spray Beconase	nasal sinus congestion	NONE	NA~ ()~~~In patient		1						1	Abdominal pain; Asthenia; Coordination abnormal; Headache; Myalgia; Palpitations; Paraesthesia; Tachycardia	FLU3~MEDEVA PHARMA, LTD.~E2805HD~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0086657	05/15/1996	OR	37.0	37		F	03/19/1996	pt recv vax 13DEC93 & exp racing heart beat, SOB, extreme aches all over body, extreme fatigue;pt cont to exp fatigue & racing beat as of this reporting date;pt also stated now has multiple allergies did not have prior to vax				Y					N	12/13/1993	12/24/1993	11		PVT	PVT	unk	unk			896086007L	1						1	Asthenia; Dyspnoea; Myalgia; Tachycardia	FLUX~PFIZER\WYETH~4938145~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0086658	05/15/1996	IL	33.0	33		M	02/27/1996	pt recv vax 20OCT94 & 4 days later pt exp a total loss of vision in one eye, which fully resolved in 6 wk;pt was examined by an ophthalmologist, but addtl details are not known as of the date of this report				Y					Y	10/20/1994	10/23/1994	3		OTH	OTH	unk	NONE		~ ()~~~In patient	896067002L	1						1	Amblyopia; Blindness; Headache; Optic neuritis; Rhinitis	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0070033	05/16/1996	OH	66.0	66		M	10/30/1995	pt exp severe emotional anxiety,h/a,stiff neck,burning upset stomach,insomnia;had a pulse in ears,skin felt creepy 2-3 hr p/vax;intraocular pressure wa reportedly 14 on 15AUG93&26 on 20OCT93										10/19/1993	10/20/1993	1	IGG 553 abn 13DEC93; IGE 126 normal 13DEC93;	UNK	UNK	Tenormin, Timoptic, APAP, Oxazepam, bellergal, HSGIC		HTN, myocardial infarction, glaucoma, allergy to ASA, iridotomy both eyes, arteriosclerotic heart disease	~ ()~~~In patient		1						2	Anxiety; Dyspepsia; Glaucoma; Headache; Insomnia; Nuchal rigidity; Paraesthesia; Skin disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0086280	05/23/1996					M	05/22/1996	plaintiff alleges that w/in 10 days of vax OCT94 pt fell ill & was ultimately dx w/GBS;pt was hosp & has undergone rehabilitation;residual sx are reported to cont;								Y	N	10/23/1994	11/01/1994	9	NONE	PVT	OTH	unk	NONE		~ ()~~~In patient	ALI96248	1						1	Guillain-Barre syndrome	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0086284	05/23/1996	PA	64.0	64		M	05/01/1996	pt recv vax 11OCT95&4 days later pt devel hallucinations&paranoid ideation;pt hosp w/resp arrest&required mechanical ventilation;pt is now vegetative state;poss creutzfeldt-Jakob disease;also therapy for depression;			Y	Y	Y		Y	Y	N	10/11/1995	10/16/1995	5	MRI's- nondiagnostic; EEG's-abnormal;Spinal Tap- nondiagnostic	OTH	OTH	Haldol	unk	pt was described as prev healthy;has hx of depression	~ ()~~~In patient	896127001L	1						1	Apnoea; Electroencephalogram abnormal; Encephalopathy; Hallucination; Myoclonus; Paranoia; Pneumonia; Stupor	FLU3~PFIZER\WYETH~4958113~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0086285	05/23/1996	FL	71.0	71		M	01/02/1996	pt recv vax 18DEC95&next day became ill;pt hosp in a comatose state&placed on a ventilator;pt died next day;death allegedly d/t skin infect;death certificate stated COD cardiac arrest,assoc w/sepsis,shock,acute renal failure,resp failure	Y	12/23/1995	Y	Y	Y	2			N	12/18/1995	12/19/1995	1		PVT	PVT	unk	NONE	pt was reportedly completely well prior to vax;	~ ()~~~In patient	896005015L	1						1	Apnoea; Cardiac arrest; Coma; Hypoventilation; Infection; Renal failure acute; Sepsis; Shock	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0086286	05/23/1996	NY	29.0			F	05/07/1996	pt recv vax&was 2wks pregnant @ the time;FEB96 pt devel abruptio placentae&the conceptus was lost;			Y	Y	Y				Y		02/01/1996			PVT	PVT	unk	unk		~ ()~~~In patient	896135007L	1						1	Placental disorder	FLU3~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0086378	05/28/1996	NV	52.0	52		F		in a few days-stroke like sx;both arms contracted against chest-fingers not aligned;no control over movement;pain in arms for a short time-unable to ambulate-drug self could not wipe self;worsened till 2 wk-w/pain able to move-paresthesia				Y					N	10/01/1995	10/01/1995	0		PVT	PVT	Estrogen;Thyroid			~ ()~~~In patient	NV96011	1						1	Hypertonia; Hypokinesia; Hypotonia; Migraine; Myalgia; Pain; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0086403	05/29/1996	TN	54.0	54		F	05/01/1996	pt recv vax; echocardiogram revealed dilated cardiomyopathy 15feb96;			Y	Y	Y	7			N	10/24/1995	02/15/1996	114		OTH	OTH		none		~ ()~~~In patient		1						1	Cardiomyopathy	FLUX~UNKNOWN MANUFACTURER~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0081711	06/03/1996	NE	40.0	40		F	01/11/1996	pt devel gen hives				Y					Y	11/06/1995	11/06/1995	0		OTH	OTH	Zoloft	unk		~ ()~~~In patient	896053009L	1						2	Injection site hypersensitivity; Pruritus; Rash; Urticaria; Urticaria	FLU3~PFIZER\WYETH~4958118~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4958118~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0082446	06/03/1996	MA	50.0	50		M	01/12/1996	pt recv vax 25OCT95 & exp loss of vision which was dx as viral induced papillitis by an ophthalmologist;tx w/ophthalmic drops;pt visual acuity has returned to baseline				Y					N	10/25/1995	11/01/1995	7		PVT	PVT	unk	unk		~ ()~~~In patient	896053008L	1						2	Infection; Optic neuritis; Visual field defect; Blindness; Infection; Optic neuritis; Visual field defect	FLU3~PFIZER\WYETH~4958090~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4958040~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0086507	06/03/1996	TX	2.0	2	.2	F	03/22/1996	pt recv vax; Pt had D & V;called MD;tenderness at inject site; ER Nurse said there was virus going around;									U	03/21/1996	03/21/1996	0		PUB	PUB		none	none	none~ ()~~~In patient	TX96068	1						1	Diarrhoea; Infection; Injection site pain; Vomiting	FLUX~UNKNOWN MANUFACTURER~K0181~4~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0086540	06/03/1996	LA	2.0	2	.8	F	05/28/1996	pt recv vax 9OCT95 & 5hr later devel a fever of 104.7;eyes rolling;pt was limp & was losing consciousness;				Y					Y	10/09/1995	10/09/1995	0	NONE	PVT	PVT	Vantin	nONE	no allergies to food or drugs;no birth defects	NONE~ ()~~~In patient		1						1	Gaze palsy; Hypotonia; Pyrexia; Stupor	FLU3~CONNAUGHT LABORATORIES~5F61082~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~1076E~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0086649	06/03/1996	MD	73.0	73		M	02/05/1996	pt recv vax & 2 days later pt did not feel well & went to bed;pt died in sleep;no hx/evidence that pt exp heart arrhythmia, chest discomfort, fatigue or weakness during the interval between vax & death;no autopsy performed;COD unk;	Y	11/29/1995							N	11/27/1995	11/29/1995	2		PVT	PVT	Benazepril HCL;Felodipine;		pt had carcinoma of the colon which was resected 2NOV95;no hx of heart disease in pt or family	~ ()~~~In patient	896038023L	1						1	Malaise	FLU3~PFIZER\WYETH~4958066~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0086664	06/03/1996	IL				M	01/17/1996	health care provider reports a false positive HIV test result following vax w/flu									Y	10/19/1995	01/15/1996	88		PUB	PUB	unk	NONE		~ ()~~~In patient	896029001L	1						1	Unevaluable event	FLU3~PFIZER\WYETH~4958124~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0086665	06/03/1996	TN	54.0			F	02/01/1996	pt recv vax 20OCT95 & exp pain in rt shoulder, & had diff elevating arm;sx persisted for 30 days;pt given Medrol dosepak & dx w/brachial plexopathy;pt cont to exp numbness & weakness in rt arm;				Y					U	10/20/1995	10/21/1995	1		OTH	PVT	unk	NONE		~ ()~~~In patient	896045016L	1						1	Hypokinesia; Myasthenic syndrome; Neuropathy; Pain; Paraesthesia; Hypokinesia; Lung disorder; Myasthenic syndrome; Neuropathy; Osteoarthritis; Pain; Tendon disorder	FLU3~PFIZER\WYETH~4958072~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4958072~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0086666	06/03/1996	NY				F	02/06/1996	pt recv vax OCT95 & exp arm pain & weakness				Y					N	10/01/1995	10/01/1995	0		PVT	PVT	unk	unk		~ ()~~~In patient	896047005L	1						1	Myasthenic syndrome; Pain	FLU3~PFIZER\WYETH~4958113~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0086667	06/03/1996	MI	33.0	33		F	01/11/1996	pt recv flu vax ID instead of an mantoux ID;pt devel fever, achiness, chills, nausea, & diarrhea;pt was recalled to facility & recv Mantoux inj in another site;									Y	01/09/1996	01/10/1996	1		PUB	PUB	Fioricet;Mantoux 9JAN96 to 9JAN96;SOMA, VERELAN, WELLBUTRIN	none		~ ()~~~In patient	896053003L	1						1	Chills; Diarrhoea; Myalgia; Nausea; Pyrexia	FLU3~PFIZER\WYETH~~UNK~SC~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~SMITHKLINE BEECHAM~1374A1~1~IM~RA~HEP B (ENGERIX-B)~1	USA		Influenza
0086670	06/03/1996	CO	32.0	32		F	01/10/1996	pt recv vax 20NOV95 & devel t100-101 which resolved;7 days p/vax devel low grade 99-100 fever that has not abated since that time;w/u performed thus far has been negative;pt c/o sore throat, bilat ofalgia, dec energy & coryza;had rash DEC				Y					N	11/20/1995	11/21/1995	1	CBC, H/H-WNL, WBC 6900-47% lymphs, 18% monos, ESR-23, skin biopsy results equivocal;VA, throat cult-negative	PVT	PVT	unk	NONE	NONE	pt reports low grade fever & local pain w/prior vax~ ()~~~In patient	896053001L	1						1	Asthenia; Ear disorder; Pharyngitis; Pyrexia; Rash; Rhinitis	FLU3~PFIZER\WYETH~4958106~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0086671	06/03/1996	KY				F	02/19/1996	pt recv vax 6NOV95 & devel cervical neck pain, upper lt arm pain, numbness down into the lt hand;treated w/physical therapy & anti-inflammatory meds;sx have since dec in severity, but cont to persist				Y				Y	Y	11/06/1995			neurological tests r/o carpal tunnel, thoracic outlet synd & cervical abnormalities	OTH	OTH	unk	unk	pt has recv flu vax in the pas w/no problems	~ ()~~~In patient	896053016L	1						1	Neck pain; Pain; Paraesthesia	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0086672	06/03/1996	UT	41.0			F	02/16/1996	pt recv vax & devel pruritus characterized by itchy palms which progressed to a gen body itch, heart burn, & heaviness in chest feeling;pt is recovered;addtl info was recv 29APR96;pt MD attributed sx to triamcinolone inj given prior to vax				Y					Y		11/22/1995			OTH	PVT	Triamcinolone inj	NONE		~ ()~~~In patient	896054001L	1						1	Chest pain; Gastrointestinal disorder; Pruritus	FLU3~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0086673	06/03/1996	CO	35.0	35		F	02/28/1996	pt recv vax 23OCT95 & devel pain, weakness, confusion & fatigue;pt to ER 10FEB96 w/chest pain;was evaluated & released;pt was found to have positive Epstein Barr titer;pt believes all sx were a result of the inj;				Y					Y	10/23/1995				PVT	PVT	Mantoux text intradermal 23OCT95 to 23OCT95	NONE		~ ()~~~In patient	896065010L	1						1	Asthenia; Chest pain; Confusional state; Infection; Myasthenic syndrome; Neck pain; Pain	FLU3~PFIZER\WYETH~4958077~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0086674	06/03/1996	CT	33.0	33		F	03/04/1996	pt recv vax 20OCT95 & devel skin hypersensitivity to the point where clothes irritate skin;pt states it feels like a bad sunburn;also exp muscle weakness & cannot pick up anything;									N	10/20/1995	11/01/1995	12		PVT	OTH	Insulin 5OCT95 to unk	unk		~ ()~~~In patient	896067003L	1						1	Hyperaesthesia; Hypotonia; Myasthenic syndrome	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0086675	06/03/1996	IL				U	01/28/1996	reporter gave 13,703 inject & reported 8 events;4 inject site rxn, 2 rashes & 3 pt w/dizziness; 8 of these rxn occurred w/in 2hr of inj;onset of 1 rxn was unk;there were no sequelae noted;									Y					OTH	OTH	unk	unk		~ ()~~~In patient	896072025L	1						1	Dizziness; Injection site reaction; Rash	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0086676	06/03/1996	FL				U	01/31/1996	reporter states approx 8 patients recv flu vax & they all devel flu-like sx;patients were all recovered as of the date of this report									Y	11/01/1995				PVT	OTH	unk	unk		~ ()~~~In patient	896073011L	1						1	Influenza	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0086677	06/03/1996	CO	54.0	54		M	01/19/1996	pt recv vax 2JAN96 & devel weakness in face, drooping eyelids, poss myasthenia gravis;no further details were known as of the date of this report									U	01/02/1996				PUB	OTH	unk	NONE		~ ()~~~In patient	896073017L	1						1	Eyelid ptosis; Hypotonia; Myasthenic syndrome	FLU3~PFIZER\WYETH~4958140~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0086678	06/03/1996	CO	41.0	41		F	03/28/1996	pt recv vax 24OCT95 & exp bouts of abd pain, backache, diarrhea, vomiting, & fatigue;CAT scan revealed calcifications of liver & gall bladder disease;UA showed inc bilirubinuria & hematuria;pt attributed problem to vax;pt recovered;				Y					Y	10/24/1995	11/01/1995	8	CAT scan-calcifications on liver gall bladder disease;UA showed inc bilirubin & hematuria;	PUB	OTH	Mantoux	NONE		~ ()~~~In patient	896095017L	1						1	Abdominal pain; Asthenia; Back pain; Bilirubinuria; Cholecystitis; Haematuria; Hepatocellular damage; Vomiting	FLU3~PFIZER\WYETH~4958077~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0086679	06/03/1996	CO	39.0	39		F	03/28/1996	pt recv vax 23OCT95 & 2mo later devel upper resp infect, fatigue, weakness, nausea, anorexia;sx persisted into JAN96;pt was recovered as of the date of this report				Y					Y	10/23/1995	12/10/1995	48		PUB	OTH	Mantoux	NONE		~ ()~~~In patient	896096001L	1						1	Anorexia; Asthenia; Myasthenic syndrome; Nausea; Pharyngitis	FLU3~PFIZER\WYETH~4958077~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0086680	06/03/1996	OH	51.0			F	01/24/1996	pt recv vax 9OCT95 & devel an inj site rxn characterized by warmth, burning, itching & a hard knot;pt was treated w/DPH;no further details were known as of the date of this report									U	10/09/1995			NONE	PVT	OTH	Timoretic	NONE		pt had localized rxn w/prev flu vax~ ()~~~In patient	896102007L	1						1	Injection site mass; Injection site pain; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4958073~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0086681	06/03/1996	OH	44.0	44		F	10/30/1995	pt recv vax 24OCT95 & devel an inject site rxn, characterized by edema, redness, warmth & tenderness;no further details were known as of the date of this report;				Y					U	10/24/1995	10/25/1995	1		OTH	OTH	unk	NONE		~ ()~~~In patient	896102010L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4958073~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0086682	06/03/1996	NE	58.0	58		F	03/07/1996	pt recv vax 24OCT95 & w/in 12-24 hrs devel in inj site rxn characterized as red, hard, & warm;f/u info was recv on 7MAR96;sx lasted 2-3 days & resolved									Y	10/24/1995	10/25/1995	1		PVT	PVT	unk	unk		~ ()~~~In patient	896115004L	1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~PFIZER\WYETH~4958137~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0086683	06/03/1996	NE				F	03/07/1996	pt recv vax 24OCT95 & w/in 12-24 hrs devel an inj site rxn characterized as red, swollen, & warm;f/u info was recv 7MAR96;sx lasted 2-3 days & resolved									Y	10/24/1995	10/25/1995	1		PVT	PVT	unk	unk		~ ()~~~In patient	896115005L	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4958137~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0086684	06/03/1996	NE	46.0	46		F	03/07/1996	pt recv vax 24OCT95 & w/in 12-24 hrs devel an inj site rxn characterized as red, swollen, & warm;f/u info was recv 7MAR95;sx lasted 3-4 days & resolved									Y	10/24/1995	10/25/1995	1		PVT	PVT	unk	unk		~ ()~~~In patient	896115006L	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4958137~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0086685	06/03/1996	MT	36.0	35		F	02/21/1996	pt recv vax 23OCT95 & exp inj site pain which greatly hindered movement of that arm;also devel numbness in the fingers, which resolved p/1 day;pt cont to exp pain as of the date of this report									N	10/23/1995	10/23/1995	0		PVT	PVT	Levothyronine, Zantac, Estaderm, Progesterone	NONE	NONE	~ ()~~~In patient	896117002L	1						1	Hypokinesia; Injection site pain; Paraesthesia	FLU3~PFIZER\WYETH~4958112~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0086686	06/03/1996	MT	28.0	28		F	02/21/1996	pt recv vax 24OCT95 & exp inj site pain which lasted more than 2wks; f/u info was recv 21FEB96;									Y	10/24/1995	10/24/1995	0		PVT	PVT	unk	NONE	NONE	~ ()~~~In patient	896117003L	1						1	Injection site pain	FLU3~PFIZER\WYETH~4958112~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0086687	06/03/1996	MT	35.0	35		F	02/21/1996	pt recv vax 23OCT95 & exp inject site pain which still persists;pt stated couldn't lift arm over head or move it side to side & remains in constant pain;exp swelling @ noc;									N	10/23/1995			NONE	PVT	PVT	unk	NONE		~ ()~~~In patient	896117004L	1						1	Hypokinesia; Injection site pain; Oedema peripheral	FLU3~PFIZER\WYETH~4958112~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0086688	06/03/1996	MT	66.0	65		M	02/21/1996	pt recv vax 24OCT95 & exp inj site pain, especially when lifting;also has the flu for 2 days;									N	10/24/1995				PVT	PVT	Hydroclorthizide, Glyburide, Vasotec	NONE	thyroid, diabetes, high BP	~ ()~~~In patient	896117005L	1						1	Hypokinesia; Influenza; Injection site pain	FLU3~PFIZER\WYETH~4958112~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0086689	06/03/1996	MT	35.0			F	02/21/1996	pt recv vax 24OCT95 & 3wk later exp inj site pain which lasted 2wk;pt was recovered as of the date of this report									Y				NONE	PVT	PVT	unk	NONE	NONE	~ ()~~~In patient	896117006L	1						1	Injection site pain	FLU3~PFIZER\WYETH~4958112~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0086690	06/03/1996	MT	34.0	34		F	02/21/1996	pt recv vax 23OCT95 & exp inj site pain, especially when raising arm;pt states lose grip on lt hand;sx were still present as of the date of this report									N	10/23/1995	10/23/1995	0		PVT	PVT	unk	NONE	NONE	~ ()~~~In patient	896117007L	1						1	Hypokinesia; Injection site pain; Myasthenic syndrome	FLU3~PFIZER\WYETH~4958112~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0086691	06/03/1996	MT	41.0	41		F	02/21/1996	pt recv vax 23OCT95 pt exp pain @ inj site as well as the neck & shoulder;pt also exp pain when lifting heavy objects;pt was recovered as of the date of this report									Y	10/23/1995	10/23/1995	0		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	896117008L	1						1	Hypokinesia; Injection site pain; Neck pain; Pain	FLU3~PFIZER\WYETH~4958112~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0086692	06/03/1996	CO	38.0	38		F	11/08/1995	pt recv vax 27OCT95 & 4hr later pt devel hives which have since resolved;a few days post vax pt c/o sore arm, 1wk p/inj devel cellulitis @ the inj site;sx are subsiding but inj site is still hot & inflamed									Y	10/27/1995	10/27/1995	0	pt had hives for 1month, resolving 5 days a/vax	PVT	PVT	Augmentin, Humibid; TB tine test	sinusitis	pt had hives for 1 month prior to vax which resolved 5 days a/flu vax;	~ ()~~~In patient	896123004L	1						1	Cellulitis; Injection site inflammation; Myalgia; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4958140~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0087004	06/05/1996	PA	1.3			F		pt recv vax 16OCT95 & 22OCT95 pt exp rash from head to toe & a t104;no further details were provided;									U	10/16/1995	10/22/1995	6	no relevant data;	OTH	OTH				~ ()~~~In patient	WAES95101529	1						1	Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~MERCK & CO. INC.~~UNK~~~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0086801	06/07/1996	NY	61.0	61		F	05/14/1996	OCT95-MAY96 lt arm muscle feels funny, redness, no swelling feels like a nodule;no functional limitations;									Y	10/01/1995	10/01/1995	0		PUB	PUB	NONE	NONE	NA	~ ()~~~In patient	NYS96037	1						1	Myasthenic syndrome; Skin nodule; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~EZ805HE~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0080003	06/18/1996	TX	54.0	54		M	06/12/1996	pt recv vax & exp sl redness in lt deltoid @ inj site;13NOV95 pt devel rt ax pain which progressed involving the rt arm & hand;devel marked weakness of the intrinsic muscles of the rt hand;pt had brachial plexus neuropathy r/t vax;pain									U	10/06/1995	11/13/1995	38	CXR nl;glycohemoglobin 8.4, random blood sugar of 220, CPK of 281 which is sl elevated;TSH was high @ 12.05 & CBC nl;	PVT	OTH	Synthroid, GLucophage, Micronase, prozac		PCN, type II diabetes, hypertension	~ ()~~~In patient		1						4	Hypertonia; Hypokinesia; Injection site hypersensitivity; Muscle twitching; Neuritis; Neuropathy; Pain; Paraesthesia; Hypertension; Hypokinesia; Injection site hypersensitivity; Insomnia; Laboratory test abnormal; Myasthenic syndrome; Neuropathy; Paraesthesia; Hormone level abnormal; Hyperglycaemia; Injection site hypersensitivity; Laboratory test abnormal; Myalgia; Myasthenic syndrome; Neuropathy	FLU3~PARKE-DAVIS~00975P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~MERCK & CO. INC.~~1~~RA~PNEUMO (PNEUMOVAX)~2|FLU3~PARKE-DAVIS~00975P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~3|PPV~MERCK & CO. INC.~~1~~~PNEUMO (PNEUMOVAX)~3|FLU3~PARKE-DAVIS~00975P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~4|PPV~MERCK & CO. INC.~~UNK~IM~RA~PNEUMO (PNEUMOVAX)~4	USA		Influenza
0087182	06/18/1996	TX	30.0	30		F	06/12/1996	24hr p/vax pt devel jerky motions in rt arm & shoulder-no local rxn rt deltoid x/soreness-movement disorder cont									N	12/13/1995	12/14/1995	1	MRI & EMG has seen 3 neurologist;lab are neg-?psychogenia etiology	PVT	PVT	NONE	NONE	NONE	na~ ()~~~In patient		1						1	Injection site pain; Muscle twitching	FLU3~PARKE-DAVIS~785P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0087234	06/24/1996	NY	54.0	54		F	04/18/1996	pt recv vax 17OCT95 & dx GBS;19NOV95 pt exp sore throat & cough;pt cont to feel bad;29NOV95 head feeling strange-really heavy;h/a like a migraine, vision was affected;eyelids drooping-had double vision & balance affected;dizzy;					Y	29	Y		Y	10/17/1995	11/19/1995	33	CT scan showed sinus infection;MRI-dx GBS	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	NYS96025	1						1	Coordination abnormal; Dizziness; Guillain-Barre syndrome; Headache; Malaise; Myasthenic syndrome; Pharyngitis; Visual disturbance	FLU3~PARKE-DAVIS~01595P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0087413	06/28/1996	CA	49.0			F	06/10/1996	pt had rxn to vax-redness, swollen arm, fever											10/26/1995			UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Oedema peripheral; Pyrexia	FLUX~UNKNOWN MANUFACTURER~5F61093~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0087584	07/08/1996	TX	62.0	62		F	06/14/1996	pt recv vax; adm to hosp w/ severe pain and inc neurological sx; after numerous testing , spinal tap confirmed GBS; transferred to hosp;spinal tab reveal inc protein;			Y	Y	Y		Y		U	10/05/1995	11/04/1995	30	Barium enemia,CT of brain, X ray of back,spinal tap: inc protein, nl sugar , urine cultures, CXR's, renal ultrasound;	PVT	PVT	lorazepam, advil,premarin, tylenol;	none	hx of renal calculi, hypertension;	~ ()~~~In patient		1						1	CSF test abnormal; Guillain-Barre syndrome; Myalgia; Myopathy; Neuropathy; Pain	FLU3~CONNAUGHT LABORATORIES~5F61093~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0087686	07/11/1996	IN	22.0	22		F	06/18/1996	pt recv vax while pregnant & child has now been found to be autistic									Y	11/26/1991				OTH	OTH	unk	unk		~ ()~~~In patient	896176003L	1						1	Foetal disorder	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0088371	07/18/1996	UT	4.0			M		pt recv vax NOV95 & 2APR96 pt exp chicken pox w/150 vesicular lesions distributed throughout body;pt not sick enough to recv APAP;pt recovered;MD reported 2 other pt who devel varicella following vax;									Y	11/01/1995	04/02/1996	153	no relevant data;	OTH	OTH				pt sibling devel chicken pox p/dose 1 of varivax vax @ age 4yr & 2yr;~ ()~~~In Sibling	WAES96042327	1						1	Dermatitis bullous; Drug ineffective; Infection	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~0439B~1~~~VARICELLA (VARIVAX)~1	USA		Influenza
0088372	07/18/1996	UT	2.0			M		pt recv vax NOV95 & 17APR96 pt exp chicken pox w/8 spots that looked like red papules;pt recovered;MD also reported two additional children devel varicella following vax;									Y	11/01/1995	04/17/1996	168	No relevant data;	OTH	OTH				pt sibling exp chicken pox w/dose 1 of varivax @ age 7yr & 4yr;~ ()~~~In Sibling	WAES96042328	1						1	Drug ineffective; Infection; Rash maculo-papular	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~0439B~1~~~VARICELLA (VARIVAX)~1	USA		Influenza
0088595	07/23/1996	IA	32.0	32		M	04/12/1996	pt recv vax 6OCT95 & MAR96 was notified that HTLV-1 test was inconclusive;blood bank informed the pt it may be r/t vax;caller also stated pt reported a brief episode of loss of consciousness of time, w/sweating;to ER CAT scan & neuro exam									U	10/06/1995	03/01/1996	147	CAT scan, neurological exam-nl	OTH	PVT	unk	NONE		~ ()~~~In patient	896108012L	1						1	Hyperhidrosis; Stupor	FLU3~PFIZER\WYETH~4958151~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0088596	07/23/1996	PA	55.0			F	05/21/1996	MD inject flu vax into a nodule on the hand of a pt w/rheumatoid arthritis;pt exp inj site pain;Medical affairs note: this is an unlabelled use of this vaccine;				Y					U	03/01/1996				PVT	PVT	Pred	NONE	rheumatoid arthritis	~ ()~~~In patient	896166001L	1						1	Injection site pain	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0088597	07/23/1996	MO				F	01/18/1996	pt recv vax & devel an inj site rxn characterized by redness, warmth, swelling & pain;pt has recovered;this is one of two patients from this site;									Y	10/25/1995	10/26/1995	1	NONE	PVT	OTH	NONE	unk	NONE	~ ()~~~In patient	896172016L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4958140~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0088099	07/26/1996	MA	48.0	48		F	07/23/1996	h/a, low grade fever for months;severe anemia, extreme fatigue (sleeping 20-22hr/day), severe bronchitis poss pneumonia, aches & pains;went to see hematologist;				Y					N	10/26/1995	10/28/1995	2	ultrasound, MRI, blood tests	PVT	PUB	Buspar, Asthmacort, Calon SR, Klonopine, Ventolin, OxygenImitres saline, fiorinal, nasalide;	asthma, high BP, migraine		~ ()~~~In patient		1						1	Anaemia; Asthenia; Bronchitis; Condition aggravated; Headache; Myalgia; Pneumonia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~4958114~7+~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~394958~1~~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0088258	07/30/1996	NY	78.0	78		F	07/25/1996	had to lift lt leg into car;aches in knees, back, lt shoulder (severe pain day & noc 4 days)-pain @ site of entry where recv vax;lt shoulder used heating pad & ointment took APAP & generic ASA;									Y	11/22/1995	11/30/1995	8		PVT	OTH	boots synthroid	dx 20NOV92 diabetic II/hypothyroid	diabetes controlled by diet & exercise	~ ()~~~In patient		1						1	Arthralgia; Injection site pain; Pain	FLU3~MEDEVA PHARMA, LTD.~E2825HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0078648	08/02/1996	SC	44.0	44		F		pt recv vax 11OCT95 & 11OCT95 approx 1hr p/vax pt exp itching & a warm feeling all over;tx w/DPH;									U	10/11/1995	10/11/1995	0	No relevant data;	OTH	OTH	Dilantin;Amitriptyline, Clonidine		sz;brain damage;	~ ()~~~In patient	WAES95110122	1						3	Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61143~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~1076B~1~IM~~PNEUMO (PNEUMOVAX)~3	USA		Influenza
0078649	08/02/1996	OK	61.0	61		F		no narrative available;									U	10/17/1995	10/20/1995	3	No relevant data;	OTH	PVT	Zocor, Zantac, Thyroid, Premarin	NONE		~ ()~~~In patient	WAES95110120	1						2	Unevaluable event	FLU3~CONNAUGHT LABORATORIES~5F61144~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0078759	08/02/1996	IL	47.0	47		F		pt recv vax 26OCT95 & 2AM next morning pt was awakened by pain in rt upper arm;the outer aspect @ inj site was double its original size w/a red line around a swollen area which was 6 to 8 diameter;area was red, hot, itchy, hard, sore				Y					Y	10/26/1995	10/27/1995	1	No relevant data;	PUB	PVT	Premarin		allergy PCN;allergy, strawberries;allergy, mosquito bites;allergy, insect bites;	~ ()~~~In patient	WAES95110030	1						2	Hypokinesia; Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Myalgia; Pruritus; Skin striae	FLU3~CONNAUGHT LABORATORIES~5F61119~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0151B~1~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0078982	08/02/1996	MD	37.0	37		M		pt recv vax 20OCT95 & 8hr later pt devel a red, swollen, & painful arm along w/104.0 fever & dizziness;pt to MD on 22OCT95 & was treated w/ATB;23OCT95 fever abated;				Y					U	10/20/1995	10/20/1995	0	No relevant data;	OTH	OTH	NONE			~ ()~~~In patient	WAES95111296	1						2	Dizziness; Oedema; Pain; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61167~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1076B~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0079093	08/02/1996	MD	73.0	73		M		pt recv vax 17OCT95 & 18OCT95 pt devel a swollen arm from the site of inj down to finger tips;area was red & warm to touch;pt recovered;20OCT95 devel myalgia, fever, fatigue & anorexia;exp required an ER MD;tx w/Ofloxacin;				Y					Y	10/17/1995	10/18/1995	1	No relevant data;	PUB	PUB		NONE		~ ()~~~In patient	WAES95121576	1						2	Anorexia; Asthenia; Injection site hypersensitivity; Injection site oedema; Myalgia; Oedema peripheral; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61120~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0962A~2~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0079769	08/02/1996	MO	80.0	80		M		pt recv vax 18OCT95 & 18OCT95 exp nasal congestion that progressed to chest congestion w/productive cough over the next couple of days;25OCT95 began w/chest pain which cont;30OCT95 MD placed on ATB;pt exp a bad cold;				Y					N	10/18/1995	10/18/1995	0	No relevant data;	PUB	PUB	Cardizem, Klor-con, Lanoxin, Furosemide, Propanolol	NONE	myocardial infarction;surgery, open heart;cancer, prostate;orchiectomy	pt exp cold w/flu vax;~ ()~~~In patient	WAES95120375	1						2	Chest pain; Cough; Lung disorder; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61220~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1076B~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0079830	08/02/1996	GA	41.0	41		F		pt recv vax 25OCT95 & 26OCT95 pt exp a reddened area around the site;the redness travelled around the side of the arm;there were many red streaks & 1 large red area;to MD 27OCT95;MD felt might be poss beginning of blood poisoning;				Y					U	10/25/1995	10/26/1995	1	No relevant data;	OTH	PVT	Relafen, Beconase inhaler		allergy, environmental	~ ()~~~In patient	WAES95120361	1						2	Infection; Injection site hypersensitivity; Skin striae; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~4~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~~1~~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0079846	08/02/1996	MT	58.0	58		F		pt recv vax 6OCT95 & 8OCT95 pt had diff eating, tongue problems, & h/a;the next day, devel a fever & had chills;10OCT95, the lt side of face was numb & could not close eye;presented to MD or ER & dx w/Bell's palsy of unk etiology;				Y					U	10/06/1995	10/08/1995	2	No relevant data;	OTH	OTH	Estrogen, Progesterone			pt exp unk even @ 15 w/ flu vax;~ ()~~~In patient	WAES95120363	1						2	Chills; Dysphagia; Eye disorder; Facial palsy; Headache; Pyrexia; Tongue disorder	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0079848	08/02/1996	TX	60.0	60		M		pt recv vax 25OCT95 & 26OCT95 pt exp excessive itching on chest, abd, neck & arms;there was redness all over body & a sl rash;rx chlor-trimeton w/no relief;									N	10/25/1995	10/26/1995	1	No relevant data;	OTH	OTH		NONE	allergy, tetracycline	~ ()~~~In patient	WAES95120362	1						2	Pruritus; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0083934	08/02/1996	FL	55.0	54		F		pt recv vax 2OCT95 & 3OCT95 pt devel swelling, redness, & soreness in arm;the pt stated that the red area was 2 in diameter;By 4OCT95 pt was getting better;pt recovered;									Y	10/02/1995	10/03/1995	1	No relevant data;	OTH	PVT				~ ()~~~In patient	WAES95100564	1						2	Myalgia; Pain; Vasodilatation; Myalgia; Oedema; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0151B~UNK~IM A~~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~0151B~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0083994	08/02/1996	FL	42.0	42		F		pt recv vax 6OCT95 & pt stated the vax hurt immed upon inj & by the afternoon it was much worse;arm started to swell to twice the nl size w/subsequent redness & soreness;broke out in cold sweats off & on through 8OCT95;pt also felt unwell;									Y	10/06/1995	10/06/1995	0		OTH	PVT	APAP, Darvocet, Naproxen;			~ ()~~~In patient	WAES95100568	1						2	Hyperhidrosis; Oedema peripheral; Pain; Vasodilatation; Chills; Hyperhidrosis; Injection site pain; Malaise; Myalgia; Oedema; Vasodilatation	FLU3~PFIZER\WYETH~4958089~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0151B~UNK~IM~~PNEUMO (PNEUMOVAX)~1|FLU3~PFIZER\WYETH~4958089~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~MERCK & CO. INC.~0151B~UNK~~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0089075	08/02/1996	NJ	89.0	88		F		pt recv vax 10OCT95 & 4hr p/vax pt exp fever, pain & redness @ inj site, pain & swelling from the elbow to the wrist;12OCT95 pt presented to MD & was dx w/bicep tendinitis;tx w/meds;				Y					Y	10/10/1995	10/10/1995	0	No relevant data;	PVT	PVT	Diabeta, Lasix, Antihypertensive,nos;		resection,lung, resection, colon;carcinoma, lung;cancer, colon;allergy PCN, & sulfa;NIDDM;HTN	~ ()~~~In patient	WAES95100763	1						1	Injection site hypersensitivity; Injection site pain; Oedema; Pyrexia; Tendon disorder	FLU3~PARKE-DAVIS~00885P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1541A~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0089082	08/02/1996	NJ	66.0	66		M		pt recv vax 16OCT95 & 18OCT95 pt exp red, hot & swollen arm where the pneumococcal vax was given;By 20OCT95 pt had recovered;no further details were provided;									Y	10/16/1995	10/18/1995	2	No relevant data;	PVT	PVT				~ ()~~~In patient	WAES95101237	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E2805HD~1~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1559A~1~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0089085	08/02/1996	NY	91.0	91		M		pt recv vax 25OCT95 & that evening pt exp soreness @ the pneumococcal vax inj site & a swollen arm;tx w/warm compresses & recovered w/in 24 to 36hr;									Y	10/25/1995	10/25/1995	0	No relevant data;	PVT	PVT			pneumonia	~ ()~~~In patient	WAES95101701	1						1	Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0089095	08/02/1996	TX	50.0			F		pt recv vax 6OCT95 & devel a fever, chills & inflamed lymph glands in axilla & breast on the side where the inj given;tx was hot compresses & sx subsided;									Y	10/06/1995	10/06/1995	0	No relevant data;	OTH	OTH				~ ()~~~In patient	WAES95101915	1						1	Chills; Lymphadenopathy; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0978A~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0089104	08/02/1996	NJ	69.0			M		pt recv vax NOV95 & w/in 3 days pt exp elevated BP to 190/100;13NOV95 pt MD inc the dosage of med;pt elevated BP persisted;									N	11/01/1995	11/01/1995	0	BP 190/100	OTH	OTH	Calan		HTN, controlled	~ ()~~~In patient	WAES95111230	1						1	Hypertension	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0089105	08/02/1996	NJ	65.0			F		pt recv vax & 2 to 3 days post vax pt exp inc BP 210/110;pt inc BP persisted & pt MD had inc the dosage of BP med;									N				BP 210/110	OTH	OTH	Vasotec;Normadyne		HTN, controlled	~ ()~~~In patient	WAES95111232	1						1	Hypertension	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0089112	08/02/1996	GA	50.0	50		F		pt recv vax 25OCT95 & 27OCT95 pt exp fever & a red hard area over the inj site the size of an egg;pt recovered;no further details were provided;									Y	10/25/1995	10/27/1995	2	No relevant data;	PVT	OTH			hepatitis;rash;poison ivy;welt;edema;Allergy, PCN;allergy, horse serum;	~ ()~~~In patient	WAES95120141	1						1	Injection site hypersensitivity; Injection site mass; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0088855	08/09/1996	MI	57.0	57		M	07/31/1996	GBS			Y		Y			Y	N	10/21/1995	11/02/1995	12		PVT	PVT				~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~5F61099~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0088869	08/12/1996	CA				M	07/23/1996	pt recv vax 29OCT93 & 26NOV93 pt exp h/a, blurred vision, gen pain;pt was allegedly dx w/GBS on 29NOV93;it is alleged that pt exp & cont to exp paralysis, loss of mobility, impaired, & periodic loss of equilibrium;								Y	N	10/29/1993	11/26/1993	28		PVT	PVT	unk	unk		~ ()~~~In patient	896207001L	1						1	Amblyopia; Coordination abnormal; Guillain-Barre syndrome; Headache; Hypokinesia; Pain; Paralysis; Visual disturbance	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0089155	08/16/1996	PA	64.0			M	08/12/1996	pt recv vax & exp abd discomfort w/o diarrhea followed w/in day by progressive limb weakness & fasciculations that evolved over a 5-day period;pt parapatetic & then wheelchair bound;lab studies nl;					Y			Y	Y				positive anti-GDIB titer;	OTH	OTH	NONE		NONE	~ ()~~~In patient	0010150960018	1						1	Abdominal pain; Hypokinesia; Laboratory test abnormal; Myasthenic syndrome; Paralysis	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation,Disabling	Influenza
0089174	08/19/1996	MD	34.0	33		F	08/15/1996	pt recv vax 2NOV95 & exp lupus flare 8DEC95 required Pred;Lupus (SLE) first dx 18JUL91 was in remission until 8DEC95;reporter feels flare d/t flu vax;visible swollen lymph nodes in neck;					Y	10			Y	11/02/1995	12/08/1995	36	UA, blood test;	MIL	MIL	Enalapril	NONE	SLE nephritis in remission	NONE~ ()~~~In patient		1						1	Condition aggravated; Lymphadenopathy	FLU3~CONNAUGHT LABORATORIES~5J61010~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0072964	08/23/1996	MN	34.0	34		M	06/19/1996	pt recv vax 11OCT94 & states inj given into the joint capsule by accident;immed p/vax exp dull achy pain in shoulder joint;6hr later noticed dec ROM which limited use of arm;condition worsened over next 6 days;severe pain;frozen joint;				Y					N	10/11/1994	10/11/1994	0		PUB	PUB	unk	NONE		~ ()~~~In patient	CO5980	1						3	Arthralgia; Arthropathy; Hypokinesia; Pain; Arthralgia; Arthropathy; Hypokinesia; Injury; Pain	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|TD~PFIZER\WYETH~~UNK~IM~~TD ADSORBED (NO BRAND NAME)~2|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~3|TD~CONNAUGHT LABORATORIES~~UNK~IM~~TD ADSORBED (NO BRAND NAME)~3	USA	Emergency room visit	Influenza
0089364	08/29/1996	MI	57.0			U	08/26/1996	pt recv vax 21OCT95 & devel tingling in legs 2NOV95, hosp 7NOV;recovered w/residual damage, unable to work;dx GBS;					Y				U	10/21/1995	11/02/1995	12		OTH	OTH				~ ()~~~In patient	CO6669	1						1	Guillain-Barre syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0089533	09/03/1996	OH	57.0	57		F	07/19/1996	pt recv vax & went limp, slept most of the day, couldn't use rt arm-couldn't use anything;to MD poss GBS;also devel collapsed lung, & a bed sore & double P;pt cannot do anything for self;			Y	Y	Y	169	Y	Y	N	11/16/1995	01/13/1996	58	many	PUB	PUB	pain	NONE	back & neck pain	pt exp GBS @ 57yr old w/flu shot;~ ()~~~In patient	OH96125	1						1	Guillain-Barre syndrome; Hypotonia; Infection; Lung disorder; Paralysis; Pneumonia; Somnolence	FLU3~PARKE-DAVIS~00885P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0090818	09/04/1996	CA	69.0			F	10/20/1995	pt recv vax & devel massive swelling @ the site of inj which lasted 3wk;pt has a hx of hives from eggs;pt has recovered;									Y				1993 flu vax (MFR unk) skin testing resulted in immed & delayed skin rxn;	OTH	OTH	unk	unk	pt has hx of hives from eggs	~ ()~~~In patient	895313016L	1						1	Injection site oedema	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0086181	09/11/1996	PA	78.0			M	11/27/1995	pt recv vax & devel hives under both arms & around trunk into the groin area;hives were characterized as itchy, hard & hurt;pt was treated by a dermatologist however the condition still exists;				Y					N	09/06/1995	09/12/1995	6		PVT	OTH	Mexitel, zantac	unk		~ ()~~~In patient	895348003L	1						2	Pain; Pruritus; Tachycardia; Urticaria; Pain; Pruritus; Skin nodule; Urticaria	FLU3~PARKE-DAVIS~~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~~1~IM~~PNEUMO (PNU-IMUNE)~1|FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0090354	09/11/1996	NM	57.0	57		F	09/22/1995	pt recv vax & during noc devel chills, h/a, lt eye pain, dizziness, sl fever, muscle aches & pains;20SEP95 devel huge, red rash & swollen area @ inj site described as hive-like;this local rxn noted by MD 21SEP95;									Y	09/19/1995	09/19/1995	0		PVT	PVT	amantadine;Betaseron;Dyazide capsules, Paxil, propranolol tablets, synthroid, xanax	unk	pt has multiple sclerosis	~ ()~~~In patient	895279004J	1						1	Chills; Dizziness; Eye pain; Headache; Injection site hypersensitivity; Injection site oedema; Myalgia; Pyrexia	FLU3~PARKE-DAVIS~02065P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~394691~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0090357	09/11/1996	TX	47.0	47		F	10/03/1995	approx 1hr p/vax the inj site became reddened, swelled (from the inj site to the elbow) & a small amount of ecchymosis was noted at the elbow;the arm is painful;									Y	08/13/1995	08/13/1995	0		PVT	PVT	unk	unk	pt may have had pnu-imune 14 in the past	~ ()~~~In patient	895285021L	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Pain	FLU3~CONNAUGHT LABORATORIES~~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~~UNK~SC~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0090358	09/11/1996	AR	48.0	48		F	10/12/1995	pt recv vax 10OCT95 & devel baseball sized swelling, redness & pain @ inj site;pt also devel a fever;sx began 3-4 hr post vax & resolved over the next 2 days;									Y	10/10/1995	10/10/1995	0		PVT	PVT	NONE	NONE		~ ()~~~In patient	895293002L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia	FLU3~PFIZER\WYETH~4958123~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~394963~1~IM~RA~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~4958123~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~394963~1~IM~RA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0090359	09/11/1996	LA				F	10/13/1995	pt recv vax 25SEP95 & by 26SEP95 pt had devel cellulitis below the inj site;tx w/ATB;pt recovered;this is one of tow patients from this site who devel cellulitis p/vax;				Y					Y	09/25/1995	09/26/1995	1		PVT	OTH	BABY ASA daily, Verapamil	HTN		~ ()~~~In patient	895304012L	1						1	Cellulitis	FLU3~PFIZER\WYETH~4958071~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~394959~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0090360	09/11/1996	LA	73.0	73		F	10/16/1995	pt recv vax 12OCT95 & 13OCT95 pt devel cellulitis 2 inches below the inj site, which was treated w/ATB;as of the reporting date, pt remained w/some residual erythema @ the site;however, swelling & pain had resolved;this is one of two pt;									Y	10/12/1995	10/13/1995	1		PVT	OTH	premarin	unk		~ ()~~~In patient	895304013L	1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~394959~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0090363	09/11/1996	VA				F	11/01/1995	pt recv vax & devel an inj site rxn characterized by swelling & redness approx 6 cm in size;									U					OTH	OTH	unk	unk		~ ()~~~In patient	895318012L	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~~UNK~IM A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0090364	09/11/1996	VA				M	11/01/1995	pt recv vax & devel an inj site rxn characterized by swelling from the deltoid to the forearm for 3 days;pt also had fever & cough for one day;pt tx w/meds;									U					OTH	OTH	unk	unk		~ ()~~~In patient	895318013L	1						1	Cough decreased; Injection site oedema; Oedema; Pyrexia	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~~UNK~IM A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0090365	09/11/1996	VA				F	11/01/1995	pt recv vax & devel an inj site rxn characterized by swelling, redness & inflammation;pt tx w/ice packs to the site;									U					OTH	OTH	unspecified arthritis meds	unk		~ ()~~~In patient	895318014L	1						1	Injection site hypersensitivity; Injection site inflammation; Injection site oedema	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~~UNK~IM A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0090367	09/11/1996	OH	69.0	69		M	11/03/1995	pt recv vax 30OCT95 & devel swelling of the arm extending from the elbow to the wrist;tx w/DPH;sx resolved in 3 days;pt had not recv vax in the past, but recovered from a case of pneumonia one month ago;				Y					Y	10/30/1995	10/30/1995	0		PVT	OTH	unk	NONE	sulfa, recovered from pneumonia approx 30SEP95;	~ ()~~~In patient	895318022L	1						1	Oedema	FLU3~PARKE-DAVIS~00475P~2~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~384960~1~SC~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0090368	09/11/1996	MS	27.0	27		M	10/20/1995	pt recv vax 19OCT95 & c/o swelling, pain & warmth @ the inj site the following day;pt had recv vax prev yr (unk if a rxn occurred);									U	10/19/1995	10/20/1995	1		OTH	OTH	unk	unk		~ ()~~~In patient	895325003L	1						1	Injection site oedema; Injection site pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~~2~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0090378	09/11/1996	ND				U	11/09/1995	pt devel gen hives 1wk p/vax;pt was treated w/Pred & hives are resolving;									U					OTH	OTH	Maxide	unk		~ ()~~~In patient	895331008L	1						1	Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0090382	09/11/1996	CO	71.0	71		F	11/14/1995	pt recv vax 6NOV95 & that day devel in inj site rxn characterized by swelling & redness;pt also c/o chills;				Y					Y	11/06/1995	11/06/1995	0		PVT	PVT	Modeurtic	NONE		pt exp chills/fever 'years ago' p 1st dose of influenza vax~ ()~~~In patient	895333012L	1						1	Chills; Injection site hypersensitivity; Injection site oedema	FLU3~MEDEVA PHARMA, LTD.~E2745HD~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0090384	09/11/1996	CO	65.0	65		F		pt recv vax 30OCT95 & that day devel an inj site rxn characterized by redness  & swelling;pt also recv flu vax that day & had a local rxn in the lt arm;				Y					Y	10/30/1995	10/30/1995	0		PVT	PVT	Lescol;Premarin	NONE		~ ()~~~In patient	895333014L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site reaction	FLU3~MEDEVA PHARMA, LTD.~E2745HD~4~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0090385	09/11/1996	CO	30.0	29		M	11/06/1995	pt recv vax 30OCT95 & that evening pt temp became elevated to 102;pt was delirious, had a dec appetite & felt debilitated;pt also c/o gen aching & pain in the inj arm,tx w/heating pad;1NOV95 pt fever broke & began to feel better;									Y	10/30/1995	10/30/1995	0		PVT	PVT	unk	unk		~ ()~~~In patient	895333016L	1						1	Anorexia; Delusion; Injection site pain; Malaise; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0090386	09/11/1996	KY	0.1	0	.1	F	11/08/1995	pt reports tremors & nystagmus 1wk p/vax;pt also recv flu vax somewhere in close proximity to that date;									U	10/24/1995	11/01/1995	8		PVT	OTH	unk	lung-CA-small cell		~ ()~~~In patient	895333024L	1						1	Nystagmus; Tremor	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~376968~UNK~IM A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0090419	09/11/1996	CA	64.0	64		M	02/02/1996	pt recv vax 28DEC95 & devel lt arm swelling w/radiating pain into the forearm & redness @ inj site (lt arm); advised to use ice 3x daily;this is 1 of 2 patients to report AE's from this site;									Y	12/28/1995	12/29/1995	1		PVT	OTH	NONE	hematuria, tarry stool, prostatism		~ ()~~~In patient	896046004L	1						1	Injection site hypersensitivity; Oedema; Pain	FLU3~PFIZER\WYETH~4658083~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~428493~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1|TTOX~LEDERLE LABORATORIES~430111~UNK~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0089887	09/16/1996	KS	51.0	51		F	09/16/1996	GBS, extreme pain, paralysis, bladder dysfunction, heat & cold sensitivity, fatigue;pt exp 5mo physical therapy going from a wheel chair, walker, cane & finally walking on own again;pt still bothered w/fatigue;pt unable to work x 1yr;					Y	30			U	10/08/1992	10/15/1992	7		OTH	OTH				~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome; Hypokinesia; Pain; Paraesthesia; Paralysis; Urinary retention	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0089892	09/16/1996	MI	52.0	52		F	06/14/1996	pt recv vax & 2wk post vax exp aching in arms & legs;6FEB96 left work w/diff walking & holding onto thing w/hands got progressively worse;saw MD 7FEB96 adm x 2 days r/o stroke d/c saw shop MD dx rxn to flu shot;pvt MD dx polyneuritis				Y	Y	8		Y	N	11/14/1995	02/06/1996	84		PUB	PUB	ASA	NONE	NONE	~ ()~~~In patient	MI96113	1						1	Gait disturbance; Myalgia; Myasthenic syndrome; Neuritis; Neuropathy; Pain	FLU3~PFIZER\WYETH~4958129~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0089982	09/17/1996	RI	74.0	74		F	09/12/1996	swelling & erythema @ inj site & surrounding tissue;										09/10/1996				PVT	OTH		NONE	on chemoterapy for cancer colon	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Oedema; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~6F71227~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~433400~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0090223	09/26/1996	AK	43.0	43		F	09/17/1996	pt recv vax & w/in 10min pt exp chest tightness & SOB;med given & MD notified more tx given & breathing returned to nl p/waiting 1hr;			Y						Y	09/13/1996	09/13/1996	0	NONE	PVT	PVT	Redux, Albuterol, Servent	NONE	Asthma	NA~ ()~~~In patient		1						1	Asthma; Chest pain; Condition aggravated; Dyspnoea; Hypoventilation	FLU3~CONNAUGHT LABORATORIES~6771195~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0090265	09/30/1996	CA	52.0	52		M	09/27/1996	death, flu-like sx 3 days p/shot;	Y	09/22/1996							N	09/18/1996	09/22/1996	4		PVT	PVT					CO6786	1						1	Anaphylactoid reaction; Asphyxia; Hypersensitivity; Influenza; Laryngeal oedema	FLUX~UNKNOWN MANUFACTURER~6F71223~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0090444	10/01/1996	HI	47.0	47		F		vertigo, n/v										01/20/1994	01/21/1994	1		PVT	OTH	Propranolol	NONE	HTN	NONE~ ()~~~In patient		1						1	Nausea; Vertigo; Vomiting	FLU3~CONNAUGHT LABORATORIES~3F41001~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0090470	10/02/1996	CA	62.0	62		F	09/24/1996	pt 4 days p/vax devel a 2cm by 2cm lobular indurated mass in rt deltoid w/warmth & external erythema;									Y	08/20/1996	08/24/1996	4		PVT	PVT	Valium, Naprosyn;PPD by Mantoux by Connaught lot# 242311 given 20AUG96;	AGE resolvingAHM	NA	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71289~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~6F81202~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0090489	10/04/1996	AK	64.0	64		M	09/30/1996	fever, h/a, myalgia, arthralgia, weakness									N	09/21/1996	09/28/1996	7	NONE	PVT	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Arthralgia; Asthenia; Headache; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~498167~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0090546	10/07/1996	PA	74.0	74		M	09/27/1996	itchy macular rash w/possible angioedema vs cellulitis @ 6cm radius from IM site;				Y					U	09/26/1996	09/27/1996	1		PVT	PVT	Theodur, Calan			~ ()~~~In patient		1						1	Angioneurotic oedema; Cellulitis; Pruritus; Rash maculo-papular	FLUX~UNKNOWN MANUFACTURER~00786P~3~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0090591	10/08/1996	CA	17.0	17		F	10/01/1996	a few min p/vax pt c/o dizziness & was leaning on the back of mom who was w/pt;pt face became pale & slowly slumped down to the floor w/o guidance;pt given Epi & 911 called;pt did not totally pass out;BP 110/80,P82,R15 pt taken to hosp;				Y	Y	3			Y	09/28/1996	09/28/1996	0	unk	PUB	PVT		NONE	arthritis	~ ()~~~In patient		1						1	Asthenia; Dizziness; Hypotonia; Hypoventilation; Pallor	FLUX~PFIZER\WYETH~4968167~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0090594	10/08/1996	AK	71.0	71		F	10/04/1996	pt recv vax 1OCT96 9AM & c/o of chills, fever & thirst inc as day progressed;c/o rt arm being sore, red, swollen & warm to touch;c/o arm being red & tender to touch from shoulder to elbow;c/o extremities being cold;									Y	10/01/1996	10/01/1996	0		PUB	PUB		NONE		~ ()~~~In patient	AK9626	1						1	Chills; Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia; Peripheral vascular disorder; Pyrexia; Thirst	FLUX~UNKNOWN MANUFACTURER~4968167~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0001D~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0090603	10/08/1996	MI	66.0	66		F	10/04/1996	c/o pain, swelling, redness & induration @ lt deltoid site-examined by MD who advised use of ice/heat, APAP/Ibuprofen if sx did not improve to call for appointment;									U	10/01/1996	10/02/1996	1	NONE	PVT	PVT			Ceclor-panic, IVP dye, sulfa-painful tongue;	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~6F71239~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~436820~1~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0090605	10/08/1996	GA	48.0	48		F	10/01/1996	pt recv flu vax 29SEP96 & on 1OCT96 reported that this AM large red warm area noted @ inj site;states knew was allergic to Thimerosal in eye solution-made eye burn;no tx other than APAP given;									Y	09/29/1996	10/01/1996	2	NONE	PUB	OTH	Zinc, Pepaid, Calritan, Lescol ASCOL, Premarin	NONE	NONE	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~6F71293~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0090607	10/08/1996	CA	47.0	47		F	10/01/1996	while the paramedics were w/daughter started c/o dizziness;paramedics had pt lay on floor & did transport to ER;pt became dizzy approx 15-20min p/vax;				Y					Y	09/28/1996	09/28/1996	0		PUB	PVT		NONE	NONE	~ ()~~~In patient		1						1	Dizziness	FLUX~UNKNOWN MANUFACTURER~4968167~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0090610	10/08/1996	NY	58.0	57		F	10/02/1996	pt c/o discomfort @ inj site of flu vax had raised hard area @ site;approx size of half dollar, discomfort extends to elbow;began about 1 1/2-2hr p/vax;ice to site-meds given;									Y	10/02/1996	10/02/1996	0	NONE	PVT	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site mass; Injection site oedema; Injection site pain; Pain	FLU3~CONNAUGHT LABORATORIES~6F71277~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~6F81204~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0090632	10/09/1996	LA	82.0	82		M	10/02/1996	devel fever, chills, myalgias p/vax;									Y	09/30/1996	09/30/1996	0	NONE	PVT	PVT		NONE	hypothyroidism	~ ()~~~In patient		1						1	Chills; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71307~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0090641	10/10/1996	MI	81.0	81		M	10/03/1996	cellulitis of rt arm;septic shock went to ER on 2OCT96;			Y	Y	Y	7			U	10/01/1996	10/02/1996	1		PVT	PVT	eye meds, A DEP, propene	NONE	no prev allergies	~ ()~~~In patient		1						1	Cellulitis; Sepsis; Shock	FLU3~PARKE-DAVIS~0096P~1~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~433401~UNK~~LA~PNEUMO (PNU-IMUNE)~1	USA	Life Threatening,Hospitalisation	Influenza
0090643	10/10/1996	KY	47.0	47		F	10/10/1996	chills, temp, muscle ache, up all noc, lethargic & drained;								Y	Y	10/09/1996	10/09/1996	0	NONE	PVT	PVT	Estrogen Transdermal	NONE	codeine allergy	~ ()~~~In patient		1						1	Asthenia; Chills; Insomnia; Myalgia; Pyrexia; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0090646	10/10/1996	CO	48.0	48		M	10/07/1996	mild to moderate case of diarrhea;									Y	10/04/1996	10/05/1996	1	NONE	OTH	PUB	hydrochloride oxy butin chloride	NONE	allergy to ampicillin;paraplegic	~ ()~~~In patient		1						1	Diarrhoea	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0090653	10/10/1996	CA	69.0	69		F	10/09/1996	nausea, h/a, rt arm weak, swollen hot, aching-cannot use-hand;feels numb-temp up into neck;									N	10/07/1996	10/08/1996	1	NONE	PUB	PUB	ASA post vax Codeine	NONE	ulcer, diverticulitis, sinus	~ ()~~~In patient	CA960106	1						1	Headache; Hypokinesia; Myalgia; Myasthenic syndrome; Nausea; Oedema; Paraesthesia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~RA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0090693	10/15/1996	NY	20.0	20		M	10/11/1996	4:00 phone call mom-states pt had hives on both arms & back;flu vax given 1yr ago;										10/11/1996	10/11/1996	0	pt is diabetic	PVT	OTH		NONE	diabetes-juvenile	~ ()~~~In patient		1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~5F71227~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0090696	10/15/1996	CO	30.0	30		F	10/10/1996	tachycardia, light headed/dizzy, numbness around cheeks, eye/lip, tongue, spiked a fever;onset w/in 15min of vax;mom is allergic to flu shot;				Y					Y	10/09/1996	10/09/1996	0		OTH	OTH	NONE	NONE	No allergy to eggs, chicken feather etc	~ ()~~~In patient		1						1	Dizziness; Paraesthesia; Paraesthesia oral; Pyrexia; Tachycardia	FLU3~CONNAUGHT LABORATORIES~6F71288~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0090697	10/15/1996	NJ	60.0	60		F	10/10/1996	pt felt weak & nauseous;vision became blurred;eyes were bloodshot;BP went up to 200/110 (although it may have already been elevated pt on BP med);				Y					Y	10/09/1996	10/09/1996	0		PUB	PVT	Cardizam, Vasotek, water pills;		HTN	~ ()~~~In patient		1						1	Amblyopia; Asthenia; Condition aggravated; Conjunctivitis; Hypertension; Nausea	FLU3~CONNAUGHT LABORATORIES~6F71255~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0090698	10/15/1996	NJ	23.0	23		F	10/10/1996	started to get really hot became confused;felt exhausted;became unconscious;awoke to see nurse bending over her;felt better, but then became faint again;this started 10min or so p/vax; poss sl convuls;				Y					Y	10/09/1996	10/09/1996	0		PUB	PVT	synthroid, Vanceril inhalant		asthma;Graves Disease;food allergies/also allergic to ragweed;	~ ()~~~In patient		1						1	Asthenia; Coma; Confusional state; Convulsion; Syncope; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71255~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0090706	10/15/1996	ND	8.0	8		M	10/07/1996	pt recv vax 4OCT96 as completion of dose started on 6SEP96;fever of 105 began 5OCT96;erythema @ site of inj w/tenderness began 6OCT96;									Y	10/04/1996	10/05/1996	1		PVT	PUB		NONE	spinal musclar atrophy	~ ()~~~In patient	ND96018	1						1	Injection site hypersensitivity; Injection site pain; Pyrexia	FLU3~PFIZER\WYETH~4968178~2~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~390931~2~IM~LL~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0090726	10/15/1996	IA	37.0	37		M	10/11/1996	pt standing-fell to the ground hitting back of head on a table-unresponsive x approx 30sec;extremely diaphoretic, pale/dusky in color;BP 74/48;pulse 60 et weak;resp 12 labored;given epi;c/o lightheaded et dizzy;amb dispatched;									Y	10/09/1996	10/09/1996	0	NA	OTH	OTH	pt denied	pt denied any illness	pt parents reported pt taking DPH for allergies p/inj given;	~ ()~~~In patient		1						1	Cyanosis; Dizziness; Dyspnoea; Hyperhidrosis; Hypotension; Pallor; Stupor; Syncope	FLU3~CONNAUGHT LABORATORIES~6F71247~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0090727	10/15/1996	TX	44.0	44		F	10/10/1996	sneezing;puffiness around eyes & face;muscles aches;									Y	10/03/1996	10/04/1996	1	NONE	PUB	OTH	OTC allergy pills			~ ()~~~In patient		1						1	Face oedema; Myalgia; Rhinitis	FLU3~PFIZER\WYETH~4968165~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0090750	10/16/1996	AZ	33.0	33		F	10/04/1996	fever 106, swelling of lateral arm from elbow to shoulders;redness, sore arm, aching in lt arm & all over;missed 2 days work;splotchy red raised rash;couldn't raise arm;pt took DPH;									Y	10/01/1996	10/02/1996	1		PUB	OTH				~ ()~~~In patient	AZ9624	1						1	Hypokinesia; Myalgia; Oedema; Pain; Pyrexia; Rash maculo-papular; Vasodilatation	FLU3~PFIZER\WYETH~4968162~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1284B~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0090756	10/16/1996	KS	65.0	65		F	10/16/1996	by 4PM pt started getting very sore muscles in lt side of abd, groin, & back;7OCT96 cont to have interior pain saw MD;med given for muscle pain 9OCT96;woke up w/shingles;pain radiating on lt half to lt breast;trouble sleeping;				Y						10/03/1996	10/03/1996	0		OTH	PUB	Provera, Premarin, Synthyroid		sulfa-allergy, thyroid	~ ()~~~In patient		1						1	Abdominal pain; Back pain; Herpes zoster; Insomnia; Myalgia; Pain; Herpes zoster; Hypertonia; Insomnia; Pain; Paraesthesia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~6F71247~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0090776	10/17/1996	GA	67.0	66		F	10/04/1996	pt recv vax 20SEP96 & 23SEP96 devel CHF w/dyspnea on exertion;cardiomyopathy was confirmed by an echocardiogram;tx in MD office & improved;reported by MD;			Y						U	09/20/1996	09/23/1996	3	echocardiogram revealed cardiomyopathy	PVT	PVT	Cozaar	NONE	hx of ideopathic cardiomyopathy	~ ()~~~In patient	0010150960026	1						1	Cardiomyopathy; Dyspnoea; Laboratory test abnormal; Right ventricular failure	FLU3~PARKE-DAVIS~00586P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening	Influenza
0090763	10/18/1996	GA	32.0	32		F	10/14/1996	12hr p/vax t104 (taking APAP q4hr) red spots on chest/stomach & arms;flu for 48hr;2 1/2 round hot, read area @ inj site;									Y	10/10/1996	10/11/1996	1	NONE	PUB	OTH	NONE	NONE	NONE	pt exp mild sx w/flu vax;~ ()~~~In patient		1						1	Influenza; Injection site hypersensitivity; Injection site inflammation; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~6F71276~3~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0090769	10/18/1996	MA	63.0	63		F	10/08/1996	sick stomach, face puffed up;stiffening arms & legs, chest & back pains, impaired speech, vision;legs numb got worse & worse;constant urination;									N	10/02/1996	10/04/1996	2		PVT	PUB	many med-heart med			~ ()~~~In patient		1						1	Back pain; Chest pain; Face oedema; Hypertonia; Paraesthesia; Pollakiuria; Speech disorder; Visual disturbance	FLU3~CONNAUGHT LABORATORIES~6F71221~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~434242~1~IM A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0090760	10/21/1996	IA	52.0	52		M	10/16/1996	2OCT96 temp up 100;3OCT96 coughing;4OCT96 coughing, temp, green phlegm;5OCT96 SOB seen in ER & adm to hosp w/dx pneumonia;			Y	Y	Y	5			Y	10/01/1996	10/02/1996	1		PUB	PVT	NONE	NONE	NKA	~ ()~~~In patient		1						1	Cough; Dyspnoea; Pneumonia; Pyrexia; Chills; Cough; Dyspnoea; Infection; Laboratory test abnormal; Lung disorder; Pneumonia; Pyrexia	FLU3~PFIZER\WYETH~4968181~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968181~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Life Threatening,Hospitalisation	Influenza
0090777	10/21/1996	MI	66.0	66		F	10/09/1996	pt recv vax 8OCT96 @ noon;awoke about 1AM w/small amt diarrhea & vomiting & again @ 6AM w/more severe vomiting w/diarrhea;that was last episode;able to retain fluids & toast c/o lethargy @ this time 12:20 noon;NOS;									Y	10/08/1996	10/09/1996	1	NONE	PUB	PUB	NONE	NONE	allergy to sulfa	NONE~ ()~~~In patient	MI96157	1						1	Diarrhoea; Somnolence; Vomiting	FLU3~PFIZER\WYETH~4968192~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0090779	10/21/1996	TN	39.0	39		F	10/17/1996	pt became pale, diaphoretic, hypotensive;placed on floor gave epi & DPH;BP 104/70, 122/70 improved sent to ER;				Y					U	10/17/1996	10/17/1996	0		OTH	OTH		NONE	NONE	~ ()~~~In patient		1						1	Hyperhidrosis; Hypotension; Pallor	FLU3~CONNAUGHT LABORATORIES~6F71237~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0090781	10/21/1996	MN	33.0	33		F	10/18/1996	sudden onset of chest tightness-worked up to throat-diff swallowing-eyes turned red-t99.9 called MD & ER later p/vomiting-pounding h/a;took analgesia;									Y	10/17/1996	10/17/1996	0	NA	OTH	PVT	NONE	NONE	NKDA	NA~ ()~~~In patient		1						1	Chest pain; Conjunctivitis; Headache; Laryngospasm; Pharyngitis; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71275~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0090782	10/21/1996	HI	41.0	40		F	09/25/1996	6PM 20SEP96 exp itching w/red welts starting on bilat thigh extending down legs;minimal welts & abd w/addtl welts & bilat arms;no recollection of ingestion of new foods or medication;took cold shower 10PM;when awoke 21SEP96 AM no welts;									Y	09/17/1996	09/20/1996	3	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	HI9611	1						1	Pruritus; Urticaria	FLU3~PFIZER\WYETH~4968177~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0090787	10/21/1996	CO	30.0	30		M	10/16/1996	about 10min p/vax pt exp vomiting, hives, resp wheezing & dyspnea;immed given adrenalin transported to ER 1 block away;DPH given & observed 1hr;				Y					Y	10/08/1996	10/08/1996	0		PUB	PVT	hydrocodone	mild URI	NONE	~ ()~~~In patient		1						1	Asthma; Dyspnoea; Urticaria; Vomiting	FLU3~PFIZER\WYETH~4968165~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0090789	10/21/1996	IL	38.0	38		M	10/09/1996	several hr p/vax pt started getting rash all over, lips feel numb, n/v, dizziness;went to ER dx w/rxn to vax;rx for pills to settle stomach but pt unsure of med name;denies med @ ER;felt better around 8Pm;				Y					Y	10/08/1996	10/08/1996	0	NA	PUB	PUB	NONE	NONE	certain meds make pt breakout-unsure of names;	NA~ ()~~~In patient	IL960099	1						1	Dizziness; Paraesthesia; Rash; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71307~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0090790	10/21/1996	GA	43.0	43		F	10/14/1996	pt awoke early AM 9OCT96, lt axillary area swollen, very tender to touch, w/very limited ROM; no fever, rash or redness noted condition not relieved by warm compresses, APAP, or gentle massage;pt notified clinic 11OCT96 & advised to see MD									Y	10/08/1996	10/09/1996	1	NONE	PUB	PVT		NONE	Iodine allergy, hayfever, asthma	~ ()~~~In patient		1						1	Hypokinesia; Oedema; Pain; Hypokinesia; Oedema; Pain	FLU3~MEDEVA PHARMA, LTD.~E3036GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~E3036GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0090793	10/21/1996	ND	46.0	46		F	10/15/1996	when eating supper, jaw felt swollen et felt swollen inside lt jaw;had discomfort et tenderness still sl sore p/ 11 days;									Y	10/04/1996	10/04/1996	0		OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient	ND96020	1						1	Oedema; Pain	FLU3~PFIZER\WYETH~4968192~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~LEDERLE LABORATORIES~438594~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0090794	10/21/1996	FL	56.0	56		F	10/10/1996	devel of hives all over body between 10-11PM 4OCT96;called ophthalmologist MD-rx for med given started 5OCT96;										10/04/1996	10/04/1996	0		PUB	OTH		NONE	Glaucoma	~ ()~~~In patient	FL96068	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71289~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0090799	10/21/1996	NH	45.0	45		F	10/17/1996	fever up to 101.8;body aches;diaphoresis, chills;dizziness;									Y	10/15/1996	10/15/1996	0		PUB	OTH	NONE	hx of mononucleosis-has episodes of fatigue & RUQ tenderness-one @ time;	asthma	~ ()~~~In patient		1						1	Chills; Dizziness; Hyperhidrosis; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4968173~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0090804	10/21/1996	NY	44.0	44		M	10/17/1996	pt became unresponsive immed p/vax;BP 90/60, P64, R16;pt became alert slowly p/1 1/2min then became lightheaded & diaphoretic;911 called et responded, no tx given to pt;									Y	10/15/1996	10/15/1996	0		OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Dizziness; Hyperhidrosis; Hypotension; Hypoventilation; Stupor	FLU3~CONNAUGHT LABORATORIES~6F71275~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0090814	10/21/1996	MI	58.0	58		F	10/10/1996	immed following flu vax pt exp a flushed feeling radiating from the chest, to the neck to the jaw, a funny taste & palpitations;pulse was 120 to 120 BP 150/90;pre flu vax was 40yr ago;no problems;									Y	10/10/1996	10/10/1996	0	hypersensitivity to flu vax;	PUB	PVT	Esterderm patch;Verelan	NONE	irregualar heart rate	NONE~ ()~~~In patient		1						1	Dysgeusia; Hypertension; Palpitations; Tachycardia; Vasodilatation	FLU3~PFIZER\WYETH~4968198~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0090816	10/21/1996	MA	63.0	63		F		pt recv vax & exp pains in chest, back-lower back & almost paralyzing & a rash;pt sick				Y					N	10/02/1996				PVT	OTH	numeorus meds since living in apt	yes	NO MD felt pets	~ ()~~~In patient		1						1	Back pain; Chest pain; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0090819	10/21/1996	MI	59.0	59		F	10/09/1996	pt stated day p/vax devel aching, chills, fatigue, sore throat;episode lasted 24hr;									Y	10/03/1996	10/04/1996	1		PUB	PUB		NONE	NONE	~ ()~~~In patient	MI96139	1						1	Asthenia; Chills; Myalgia; Pharyngitis	FLU3~PFIZER\WYETH~4968144~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0090835	10/22/1996	AL	27.0	27		M	09/30/1996	became sick w/flu which turned into pneumonia, which prolonged until became unable to breathe which resulted in hosp in which they did a lung biopsy, finding out pt had sarcoidosis;tx large doses of steroids since JUN96;has had to retire;			Y	Y				Y	N	10/17/1995	10/20/1995	3	lung biopsy-hosp	PVT	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Dyspnoea; Infection; Influenza; Pneumonia; Sarcoidosis	FLU3~PARKE-DAVIS~00295P~1~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Disabling	Influenza
0090840	10/22/1996	VA	23.0	23		F	09/17/1996	reddening/itching @ site upon inj;became SOB/coughing;hx severe asthma;given med P104;cont coughing, P132;pt cough int, SOB, P104 d/c to home;exp dizziness/SOB;EKG nl w/mult PVC's;adm to hosp for probable allerg rxn;					Y	6			Y	09/13/1996	09/13/1996	0	CXR, sputum, gram stain, CX, CBC, chem 7, ABG, oximeter etc;	PVT	UNK		asthma	multiple environmental allergies	~ ()~~~In patient		1						1	Asthma; Condition aggravated; Cough; Hypersensitivity; Injection site hypersensitivity; Pruritus; Tachycardia; Ventricular extrasystoles	FLU3~PFIZER\WYETH~4968171~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0091256	10/22/1996	TX	34.0	34		M	10/16/1996	raised splotchy area throughout the trunk area w/itching & discomfort started 8-10hr p/vax;MD gave pt cortisone inj;now presents w/cont rash & itching;									Y	09/30/1996	10/01/1996	1	NONE	PUB	PUB	NONE	NONE	NA	~ ()~~~In patient	TX96172	1						1	Pain; Pruritus; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~6F71307~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091259	10/22/1996	MA	69.0	69		M	10/19/1996	24hr post vax pt exp itching around arm, neck, hive, rash all over body-MD rx allergy pills-itching over entire body lasting 48-72hr				Y					Y	10/09/1996	10/10/1996	1	unk/NONE	OTH	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Pruritus; Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0091260	10/22/1996	TN	26.0	26		F	10/18/1996	1hr post vax pt scalp began itching-becoming more intense-lip felt funny-was swollen called hosp instructed to take DPH;significant itching all over body;face swollen, hives on thighs, some wheezing, abd cramps, diarrhea, splotchy;				Y					Y	10/15/1996	10/15/1996	0		OTH	PVT	unk	NONE	seasonal rhinitis	~ ()~~~In patient		1						1	Abdominal pain; Asthma; Diarrhoea; Face oedema; Oedema peripheral; Pruritus; Rash maculo-papular; Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71277~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091261	10/22/1996	NY	29.0	29		F	10/18/1996	1 day post vax pt exp high fever, severe aches, chills;									Y	10/15/1996	10/17/1996	2	NONE	PUB	PUB	Synthroid, Zantac	NONE	Sinus	~ ()~~~In patient		1						1	Chills; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0091262	10/22/1996	MA	38.0	38		F	10/18/1996	high temp 101, body aches, chills,h/a				Y					Y	10/17/1996	10/17/1996	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MA9612	1						1	Chills; Headache; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0091269	10/22/1996	NJ	48.0	48		M	10/15/1996	site ecchymosis w/radiating soreness to shoulder;										10/09/1996	10/11/1996	2	NONE	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Ecchymosis; Injection site reaction; Myalgia	FLU3~CONNAUGHT LABORATORIES~E3026GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091274	10/22/1996	FL	23.0	23		F	10/11/1996	beginning on 8OCT96 pt exp n/v & t102;pt seen in office w/ c/o of above & redness & swelling @ inj site of rt deltoid on10OCT96;tx w/ATB dx infect vs allergy;				Y						10/07/1996	10/08/1996	1	NONE	PVT	OTH		NONE	NONE	~ ()~~~In patient		1						1	Hypersensitivity; Infection; Injection site hypersensitivity; Injection site oedema; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71278~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1284B~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0091278	10/22/1996	ND	36.0	36		F	10/08/1996	red rash;arm swelled up;arm hurt;made pt sleepy;									Y	10/08/1996				MIL	MIL				~ ()~~~In patient		1						1	Myalgia; Oedema peripheral; Rash; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0091281	10/22/1996	MO	28.0	28		F	10/15/1996	pt had a sz about 5min p/vax x1min & then seemed fine;p/about 5min pt begin to have resp distress;epi given & emergency assist summoned;pt transported to hosp for eval;8OCT pt reported had been given DIlatin for sz & discharged;was better;				Y					Y	10/03/1996	10/03/1996	0	NA	OTH	PVT	allergies & Morphine & tetracycline	NONE	sz disorder dx in APR96 to Thimerosal, PCN	unk~ ()~~~In patient		1						1	Condition aggravated; Convulsion; Dyspnoea	FLU3~PFIZER\WYETH~4968203~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091284	10/22/1996	VA	36.0	36		F	10/17/1996	devel itchy red hives some hr p/vax occurred mostly on face;some on arms & trunk;resolved over 3 days no tx (had ppd skin test 9OCT96);									Y	10/09/1996	10/09/1996	0	NA	PVT	PVT	Birth control pills, OTC vitamins, calcium	NONE	Ibuprofen gave similar sx yrs ago	~ ()~~~In patient		1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71229~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091288	10/22/1996	FL	70.0	69		F	10/17/1996	local reddness, swelling, heat in area of inj lt deltoid;rx DPH & ice to area off & on;				Y					Y	10/15/1996	10/15/1996	0	NONE	PVT	PVT	Advil (OTC)	NONE	allergies-PCN, Ceclor, Tetracycline, Seldane	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PARKE-DAVIS~00786P~4~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1626B~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0091291	10/22/1996	MN	6.0	6		M	10/07/1996	mom reports t103-101-rt arm swollen & reports discomfort;APAP alternated w/ Ibuprofen;									Y	10/01/1996	10/02/1996	1	NONE	PVT	PVT	Risperdal, RItalin, Lithium		ADHD, FAS/drug exp w/static encephalopathy	NONE~ ()~~~In patient		1						1	Oedema peripheral; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71288~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~436822~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0091295	10/22/1996	MN	7.0	7		F	10/07/1996	mom reports pt has vomiting & diarrhea, low grade fever-unsure of coincidental or rxn;Tigor supp;									Y	10/02/1996	10/02/1996	0	NONE	PVT	PVT	Respirdal	NONE	arthritis immune def, MR, VSD defect, Behavior problem, PPD, cong rubella synd w/deafness, lt eye blindness, CP w/spastic displegia;	NONE~ ()~~~In patient		1						1	Diarrhoea; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71288~4~A~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~436822~1~A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0091298	10/22/1996	NY	65.0	65		U		sore arm-h/a, temp (fever);aches (body)-glassy eyes, runny, then stuff from nose;some cough, sore throat, 6 days sick;									Y	10/01/1996	10/02/1996	1		OTH	OTH	NONE	NONE	NONE x/PCN	pt exp sore arm only w/ flu shot~ ()~~~In patient		1						1	Cough; Headache; Malaise; Myalgia; Pharyngitis; Pyrexia; Rhinitis; Stupor	FLU3~MEDEVA PHARMA, LTD.~E3096GB~4~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0091300	10/22/1996	OH	66.0	66		F	10/10/1996	redness, itching, swelling @ site of inj started 9OCT96;better today;									Y	10/07/1996	10/09/1996	2		PVT	PVT	Xanax, Calcium, ASA, Naprosym			~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4968139~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091302	10/22/1996	MD	30.0	29		F	11/13/1995	10NOV95 PM arm sore & hot to touch;11NOV95 AM arm sore, hot to touch @ least 4inches in diameter;12NOV95 arm the same but itched terribly;felt better;13NOV95 arms the same measure 3x3 1/2inch in diameter welt;tx Ibuprofen & DPH, ice;									N	11/10/1995	11/10/1995	0	NA	PVT	PVT	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Chills; Myalgia; Pruritus; Somnolence; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61144~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091305	10/22/1996	PA	85.0	85		F	10/10/1996	swollen tongue				Y						10/08/1996	10/10/1996	2		PVT	OTH	Vasotec;HCTZ, DIlantin, KTAB, Ditropan			~ ()~~~In patient		1						1	Tongue oedema	FLU3~CONNAUGHT LABORATORIES~6F71275~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091306	10/22/1996	IL	41.0	41		F	10/09/1996	pt recv vax in AM & 3PM c/o chills, muscle aches, n;came to ER 930PM t102.7, chills, joint pain, n/v x 5;pain & swelling @ inj sit lt deltoid;recv IV fluids, compazine, Toradol, zantac;d/c from ED much improved;dx w/febrile synd post				Y					Y	10/07/1996	10/07/1996	0	CBC, SMA nl;Sed rate 40 (nl 0-20);	PVT	PVT	APAP	NONE	allergy PCN, hx PVD	~ ()~~~In patient		1						1	Arthralgia; Chills; Dehydration; Injection site oedema; Injection site pain; Myalgia; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~1066P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0091307	10/22/1996	NJ	42.0	42		F	10/19/1996	pt exp swelling @ inj site, warm @ inj site;pt perm disabled w/fragile x synd;								Y	N	10/15/1996	10/17/1996	2	NONE	OTH	PUB	Prozac	NONE	pollen-fragile X synd	~ ()~~~In patient		1						1	Injection site oedema; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0091314	10/22/1996	PA	10.0	9		F	10/09/1996	pt recv vax & 5 min p/vax site area became swollen & red;approx 3/4 in size;cold compress applied, DPH;no SOB, no wheezing;									Y	10/09/1996	10/09/1996	0	NONE	OTH	PVT	NONE	URI	CP	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PARKE-DAVIS~01286P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0091318	10/22/1996	WI	57.0	57		F	10/11/1996	local erythema, swelling distal to inj site <24hr p/vax;									U	10/10/1996	10/11/1996	1		PVT	PVT	?	NONE	multiple med allergies	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4968139~3~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1392B~2~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0091320	10/22/1996	MI	73.0	73		F	10/10/1996	swelling of lt arm shoulder to elbow;									U	10/03/1996	10/10/1996	7	NA	PVT	PVT		NONE	NA	NA~ ()~~~In patient		1						1	Injection site oedema	FLU3~PARKE-DAVIS~00966P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0091321	10/22/1996	MA	51.0	51		F	10/09/1996	approx 36hr p/vax pt c/o gen hives, inc swollen eyelids, no resp distress;took DPH on own;instructed to go to ER p/consulting primary care provider;in ER given IV solumedrol & DPH put on pred & DPH;				Y					Y	10/01/1996	10/03/1996	2	NONE	PUB	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						1	Face oedema; Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71226~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091326	10/22/1996	MI	45.0	45		F	10/09/1996	swollen eye's, severe redness (no white's) x 2wk;2wk appt MD office;									Y	09/24/1996	09/25/1996	1	culture (eye)-no growth	PVT	PVT	Synthroid/daily		hyperthyrodism	~ ()~~~In patient		1						1	Conjunctivitis; Face oedema	FLU3~CONNAUGHT LABORATORIES~6F71285~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091327	10/22/1996	KY	66.0	66		F	10/07/1996	facial swelling, prolonged induration @ inj site >5 days;									U	10/03/1996	10/04/1996	1	NA	PVT	UNK		COPD;HBP	NKMA	NONE~ ()~~~In patient		1						1	Face oedema; Injection site mass	FLU3~PFIZER\WYETH~4968155~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091331	10/22/1996	AK	39.0	39		F	10/09/1996	myalgias, chills onset 5OCT96;no treatment;				Y					Y	10/03/1996	10/05/1996	2	NONE	PUB	PUB		NONE	allergies: Erythromycin, PCN;obesity, lt trigeminal nerve neuropathy, nyofacial pain synd	NONE~ ()~~~In patient		1						1	Chills; Myalgia	FLU3~PFIZER\WYETH~4968167~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091333	10/22/1996	TX	79.0	79		M	10/11/1996	watery eyes;runny nose;very sore, raw throat;croupy cough, expectorant (very persistent);some SOB;felt ill for a wk;Nyquil;cough drops;medi haler x3 for SOB;									Y	10/04/1996	10/05/1996	1		OTH	OTH		NONE	low platelet count, otherwise good (emphysemia);	NONE~ ()~~~In patient		1						1	Cough; Dyspnoea; Lacrimal disorder; Laryngitis; Malaise; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0091334	10/22/1996	TX	77.0	77		F	10/11/1996	watery eyes;runny nose;very sore, raw throat;croupy cough, expectorant (very persistent);laryngitis;felt ill for a wk;gargled w/salt water, cough med, cough drops, DPH;									Y	10/04/1996	10/07/1996	3		OTH	OTH		NONE	good (mild emphysemia)	pt exp red, hot inj site flu vax;~ ()~~~In patient		1						1	Cough; Lacrimal disorder; Laryngitis; Malaise; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0091615	10/22/1996	WI	70.0	70		F	10/10/1996	8hr post fax-chills, dizziness, t102 lasting approx 6hr;vomited x1;body aches & pains;better by 3rd day;										10/08/1996	10/08/1996	0		UNK	UNK				~ ()~~~In patient		1						1	Chills; Dizziness; Myalgia; Pain; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0091185	10/23/1996	WV	49.0	49		F	10/17/1996	pt devel fever, chills, vomiting reportedly 5 1/2hr p/vax;sx persisted & was brought to hosp where pt was adm 13OCT96;blood cult drawn;result recv 16OCT96 showed salmonella;					Y				U	10/12/1996	10/12/1996	0	blood cult, CBC	UNK	UNK	other than methotrexate is unk	hx of rheumatoid arthritis & colitis				1						1	Chills; Infection; Pyrexia; Sepsis; Vomiting	FLU3~PFIZER\WYETH~4968159~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0091192	10/23/1996	IA	52.0	52		M	10/15/1996	edema, swelling of hands, rt foot, eyelids, back, buttocks, SOB, itching, mild chest pain, sl disorientation 10OCT96;Pred burst & DPH given 11OCT96;				Y					Y	10/08/1996	10/10/1996	2	BP 122/70;pulse 80;resp 18;	PUB	PUB	Nitro glycerin Blockers;cardiac meds- 6 or 7	NONE	coronary heart disease;angioplasty ballon 1995;stent insert SEP96;	~ ()~~~In patient	IA96036	1						1	Chest pain; Confusional state; Dyspnoea; Face oedema; Oedema; Oedema peripheral; Pruritus	FLU3~PARKE-DAVIS~00586P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0091195	10/23/1996	NC	80.0	80		F	10/10/1996	noticed PM 9OCT redness of rt deltoid then 10OCT AM arm more red, swollen & sore;redness from deltoid down to with 2 of elbow;knot in deltoid approx 10x10mm;NOS;										10/09/1996	10/09/1996	0		PUB	OTH	med for BP & cholesterol	NONE	NONE	NA~ ()~~~In patient	NC96111	1						1	Myalgia; Oedema; Skin nodule; Vasodilatation	FLU3~PARKE-DAVIS~00986P~4~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1626B~1~IM A~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0091197	10/23/1996	CO	55.0	55		F	10/17/1996	no sx day of vax;awoke next AM @ 5:00 w/hives over trunk of body;saw MD 9AM unable to ID any other cause;started med @ 11AM on 12OCT had slowed down rxn, but still breaking out w/new hives today 17OCT96;				Y					N	10/11/1996	10/12/1996	1	NONE	OTH	PVT	NONE	NONE	PCN	pt exp whole arm swollen @ 45yr w/Td booster;~ ()~~~In patient		1						1	Urticaria	FLU3~PFIZER\WYETH~40849351~4~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091198	10/23/1996	UT	72.0	72		M		pt recv vax 9OCT96 & had hot very very red flush over face & chest;ear ringing & sl weakness in body;flush would last 3hr come & go for 3 days;ear still ringing today;stiff neck today is about 18OCT96;									Y	10/09/1996				PUB	OTH	Priloceg	ONE	NONE	~ ()~~~In patient		1						1	Myasthenic syndrome; Nuchal rigidity; Tinnitus; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0091202	10/24/1996	MS	54.0	54		F	10/16/1996	pt began to c/o numbness & tingling in lat arm;noted to have bright red color up lt arm;whelps & itching upper lat arm began to swell;pt c/o rapid heart beat but only p/1st epi given;VS 256PM BP 160/84, R22, P100-3PM P98, R24, BP 158/80;			Y	Y	Y	1			Y	10/09/1996	10/09/1996	0	pt stated no lab done @ hosp;	PUB	PUB	Coumadin	taking Coumadin d/t blood clot d/t auto accident	allergic to heparin	NA~ ()~~~In patient	MS96040	1						1	Hypertension; Hyperventilation; Oedema; Palpitations; Paraesthesia; Pruritus; Tachycardia; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E3086GA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0091206	10/24/1996	VA	46.0	46		F	10/18/1996	local induration & erythema 5x3cm-no resp distress or other systemic complaints;									Y	10/17/1996			NONE	PUB	PUB	Serevent, Beclovent Intal, albuterol, Depro provera, Cardgen;	NONE reported	HTN, COPD, hypercholesterolemia, allergy PCN, cephalozines	~ ()~~~In patient	VA96070	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PARKE-DAVIS~00686P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0091207	10/24/1996	TN	38.0	38		M	10/15/1996	345PM vax given 345PM pt c/o tiredness & feeling bad;BP 102/77;states was sleep deprived & had not eaten since 6AM -42PM & states light-headed et feeling strange;pallor noted w/decreased alertness;epi given;pt did not go to ER felt better									Y	10/15/1996	10/15/1996	0	NA	OTH	PVT	Ventolin inhaler	NONE	asthma	NONE~ ()~~~In patient		1						1	Anorexia; Asthenia; Dizziness; Insomnia; Malaise; Pallor; Somnolence	FLU3~CONNAUGHT LABORATORIES~6F71246~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091209	10/24/1996	KS	43.0	43		M	10/11/1996	36-48hr p/vax hives, itching, scalp, hands swelling, itching on DPH 3-4 days stopped it & sx reappeared;cont to have swollen fingers, also heavy feeling in deltoid when vax given;									U	09/12/1996	09/14/1996	2	NONE	PUB	PVT		NONE	NONE	~ ()~~~In patient	KS96033	1						1	Myasthenic syndrome; Oedema peripheral; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71222~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091210	10/24/1996	VA	36.0	36		F	10/17/1996	returned approx 30min p/vax w/itching all over, throat tight, visibly anxious;1/2cc epi given;sx eased w/in 2min;second dose epi given 7min later;rescue squad arrived @ scene 3min p/2nd dose;				Y					U	10/17/1996	10/17/1996	0		OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Anxiety; Laryngospasm; Pruritus	FLU3~CONNAUGHT LABORATORIES~6F71237~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091211	10/24/1996	TX	33.0	33		F	10/17/1996	pt had immed rxn @ time of flu inj of 15mm induration no c/o pain or itching;20 min later pt c/o redness & itching-arms-neck;cough, no SOB seen by MD;allerg rxn;				Y					Y	10/17/1996	10/17/1996	0		PVT	PVT	Piroxicain;Norvasc	NONE	allergic PCN, Darvon;Hypertension, lupus	NONE~ ()~~~In patient		1						1	Cough; Hypersensitivity; Injection site mass; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71239~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091212	10/24/1996	TX	58.0			F		pt recv vax & exp nausea & shakiness approx 15min later;epi given;taken to amb per stretcher by paramedics;				Y					U	10/16/1996	10/16/1996	0	NA	OTH	OTH		NONE	NKDA-no significant med history	NONE~ ()~~~In patient		1						1	Nausea; Tremor	FLU3~CONNAUGHT LABORATORIES~6F71273~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091217	10/24/1996	CA	8.0	8		M	10/22/1996	inj site became swollen, tender the following day devel rash @ inj site, rash spreading 2 days later tx was to use warm compress & massage;take DPH;									U	10/16/1996	10/17/1996	1	NONE	PVT	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Rash	FLU3~MEDEVA PHARMA, LTD.~E3016FA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARCEL~MERCK & CO. INC.~VHA187A2~UNK~IM~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0091218	10/25/1996	NY	62.0	62		F	09/26/1996	pt devel weakness of extremities p/about 2 1/2-3wk;pt started w/bell's palsy & progressed to apresis of extremities;pt got plasmapharesis @ hlth center;					Y	25			Y	11/07/1995	11/25/1995	18	pt had EMG done at hlth center	PVT	OTH		NONE		~ ()~~~In patient		1						1	Facial palsy; Myasthenic syndrome; Paralysis	FLU3~PFIZER\WYETH~4958114~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0091221	10/25/1996	NY	2.0	2	.0	M		cough, wheezing, urticaria;					Y				Y	10/15/1996	10/15/1996	0	0x sat-94	PVT	OTH		mild URI	imperforate anus/biscuspid aortic valve/asthma;	~ ()~~~In patient		1						1	Asthma; Cough; Urticaria	FLU3~PFIZER\WYETH~4968173~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|VARCEL~MERCK & CO. INC.~0838D~1~SC~~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0091222	10/25/1996	AL	37.0	37		F	10/18/1996	pt c/o of rush feeling-pt was put in position feet up;arm started to devel a rash, w/swelling & a feeling of warmth-MD was notified;ordered DPH;pt was monitored for over 45min;arm looked better p/s felt OK;									Y	10/18/1996	10/18/1996	0	PB, pulse, resp  checked p/local rxn;	PVT	UNK	NONE	NONE	EES-sulfa-Indocin-Ceclor per pt (endometrosis);	~ ()~~~In patient		1						1	Dizziness; Oedema; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71307~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091223	10/25/1996	CA	40.0	40		F	10/20/1996	feeling sl unwell 19OCT AM;1030AM 19OCT noted red itchy, sl edematous area inside both wrists;rash progressed up forearms;lt side upper lip swollen by 330PM;scattered areas of hives started DPH;swollen face & urticaria w/mild angio ed				Y						10/18/1996	10/19/1996	1		PUB	OTH	Lupron 23SEP96	NONE	endometriosis dx 4SEP96;	NONE~ ()~~~In patient		1						1	Angioneurotic oedema; Face oedema; Malaise; Oedema peripheral; Pruritus; Rash; Urticaria; Vasodilatation	FLU3~PARKE-DAVIS~00676P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0091230	10/25/1996	AR	55.0	55		M	10/18/1996	15OCT96 pt recv vax 1030AM by 1130PM had fever 104.1, diff in urinating, retention of urine, & joint & muscle pain;16OCT96 urination Ok, temp nl, dizzy, gut pain, 6 episodes of diarrhea;17OCT96 tinnitus;18OCT96 all signs & sx gone;									Y	10/15/1996	10/15/1996	0		PUB	UNK	Paxil	NONE	Gantrisin, panic disoder	NONE~ ()~~~In patient	AR9674	1						1	Abdominal pain; Arthralgia; Dizziness; Dysuria; Myalgia; Pyrexia; Tinnitus; Urinary retention; Arthralgia; Deafness; Dizziness; Myalgia; Pyrexia; Rhinitis; Tinnitus	FLU3~CONNAUGHT LABORATORIES~6F71307~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71307~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0091235	10/25/1996	UT	51.0	50		F	10/21/1996	2in in diameter raised reddened area w/itching @ site of inj (deltoid) transient dizziness for approx 15min;pulse-100 n/c of of dyspnea or chest tightness;med prescribed x 1;localized rxn lasted 3 days;									Y	10/14/1996	10/14/1996	0	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Dizziness; Injection site hypersensitivity; Injection site mass; Injection site oedema; Pruritus	FLU3~CONNAUGHT LABORATORIES~6F71289~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091236	10/25/1996	UT	32.0	32		F	10/21/1996	2-3in in diameter raised reddened area w'itching & hot to touch @ the site of inj;localized rxn lasted 5 days;									Y	10/11/1996	10/11/1996	0	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71289~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091238	10/25/1996	NY				U		local pain & tenderness;									U	10/17/1996	10/18/1996	1	NONE	PUB	PVT	NONE	local pain	NONE	NA~ ()~~~In patient		1						1	Injection site pain	FLU3~PFIZER\WYETH~4968185~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091239	10/25/1996	NY	47.0	46		M	10/18/1996	local inflammation w/cellulitis, elevated local temp;inc tenderness & redness;									U	10/17/1996	10/18/1996	1	NONE	PUB	PVT	NONE	local pain & cellulitis	NONE	~ ()~~~In patient		1						1	Cellulitis; Injection site inflammation; Injection site pain; Injection site reaction; Vasodilatation	FLU3~PFIZER\WYETH~4968185~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091241	10/25/1996	AZ	0.9	0	.9	M		brief cyanotic (30sec) episode followed by lethargy & deep sleep;recovered by 30min;									Y	10/17/1996	10/17/1996	0	NONE	PVT	PVT		NONE	reactive ariway disease	~ ()~~~In patient		1						1	Cyanosis; Somnolence	FLU3~PARKE-DAVIS~01186P~1~~LL~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0091242	10/25/1996	NY	36.0	36		F	10/21/1996	pt recv vax 1245PM on 11OCT96 & @ 245PM on 11OCT96 pt c/o tightness in chest/weak/dizzy/extremities tingling & numb feeling;taken to ER via ambulance-recv 02 & IV;				Y					Y	10/11/1996	10/11/1996	0	CBC, U/A, SMA7, cardiac enzymes, PT & PTT	PUB	OTH	Beconase, vanceril, Proventil taken 15min prior to rxn;	NONE	hx of asthma	~ ()~~~In patient		1						1	Asthenia; Chest pain; Dizziness; Paraesthesia	FLU3~PFIZER\WYETH~4968186~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091244	10/25/1996	TX	41.0			F		pt recv vax in lt arm @ 7PM & exp head pressure @ 715PM; BP 120/74, HR 84; epi given;exp flushing & funny feeling prior to epi;paramedics took pt to ambulance per stretcher;									U	10/16/1996	10/16/1996	0	NA	OTH	OTH	NA	NONE	NKDA-no significant med history	NONE~ ()~~~In patient		1						1	Headache; Malaise; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71273~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091245	10/25/1996	AL	29.0	29		F	10/18/1996	swelling-pain in lateral aspect of lt arm extending distally to wrist-w/erythematous rash on dorsum;									Y	10/16/1996	10/17/1996	1	NA	PVT	PVT	Premarin, Loestrin-Covera HS	NA	allergic-Codeine;HTN-sarcoidosis	NA~ ()~~~In patient		1						1	Oedema; Pain; Rash	FLU3~CONNAUGHT LABORATORIES~6F71288~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~429998~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0091246	10/25/1996	PA	52.0	52		F	10/12/1996	pt recv vax & w/in approx 1/2hr pt returned w/ c/o feeling SOB, dizziness, light-headedness;noted facial flushing;BP 133/88, P88, R16;cracked open an NH2 packet;pt stated did not feel better BP 108/70, P120, R24;epi given;pale, diaphoretic;				Y					Y	10/12/1996	10/12/1996	0	NONE	OTH	OTH	unk	NONE	nONE	~ ()~~~In patient		1						1	Dizziness; Dyspnoea; Hyperhidrosis; Pallor; Tachycardia; Vasodilatation	FLU3~PFIZER\WYETH~4968170~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091353	10/28/1996	KS	16.0	16		F	10/09/1996	morning p/vax pt devel scratchy throat;hr later pt stated afraid & wanted to hurt self;was combative, looked psychotic & had a contusion from banging head against the wall;pt hosp;stated afraid might hurt other & she was Mary Queen of scott				Y	Y				U	10/01/1996	10/02/1996	1		OTH	PUB	Triphasil-28 daily	NONE	pt cut wrists last yr;	~ ()~~~In patient	896285006L	1						1	Anxiety; Condition aggravated; Ecchymosis; Hostility; Injury; Paranoia; Pharyngitis; Psychotic disorder	FLU3~PFIZER\WYETH~4968138~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0091354	10/28/1996	GA	29.0	29		F	10/24/1996	quarter size whelps 2hr p/vax, on hips;inc rash & whelps the following day w/lip swelling;stable @ d/c will be re eval in 48hr;returned in 2hr >condition worsen-adm;allerg rxn;				Y	Y					10/23/1996	10/23/1996	0		PUB	OTH		NONE	negative prev hx	NONE~ ()~~~In patient		1						1	Face oedema; Hypersensitivity; Rash; Urticaria	FLU3~PFIZER\WYETH~4968159~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0091356	10/28/1996	CA	72.0	72		M	10/24/1996	next day p/vax exp nausea, fatigue, h/a, abd distention;will see MD again today;				Y						09/30/1996	10/01/1996	1		PVT	PVT	Cozar & atenol	URI	fluctuating HTN	~ ()~~~In patient		1						1	Abdominal distension; Asthenia; Headache; Nausea	FLU3~PFIZER\WYETH~~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091359	10/28/1996	MN	38.0	38		F	10/27/1996	arm swollen @ site of  air inj began to feel feverish, eyes swollen, felt very nauseated, vomited approx 24hr post vax;									Y	10/25/1996	10/25/1996	0	NONE	OTH	PVT	NONE	NONE	env. sensitivities	~ ()~~~In patient		1						1	Face oedema; Injection site oedema; Nausea; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0091361	10/28/1996	TX	47.0			F		pt recv vax & approx 15min later exp dizziness/flushing/shaky feeling;BP 128/82, HR 84;tx w/epi;layed down approx 30min;									Y	10/17/1996	10/17/1996	0	NA	UNK	OTH		NONE	NKDA-no significant med history	~ ()~~~In patient		1						1	Dizziness; Hypertension; Tremor; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71273~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091362	10/28/1996	VA	45.0	45		M	10/18/1996	pain & swelling around inj site of rt arm (rt arm circumference 38cm;lt arm 34); tx started 17OCT96 w/Pred & ATB;total resolution 23OCT96;				Y					Y	10/16/1996	10/16/1996	0		PVT	PVT		lupus	NONE	~ ()~~~In patient		1						1	Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~00276P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0091364	10/28/1996	MN	63.0	62		M	10/22/1996	pt recv vax & exp sore throat on onset, fever, dry cough-deep from chest & cont, mucous buildup in throat, inj area swelled, turned red, hurts still hurts as of this date 22OCT96;									Y	10/07/1996	10/11/1996	4		OTH	OTH	Temouate	NONE	NONE	pt exp flu rxn @ 62~ ()~~~In patient		1						1	Cough; Headache; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pharyngitis; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0091376	10/28/1996	MA	45.0	45		F	10/24/1996	dizziness & nausea began p/working on computer afternoon p/vax;has tendency toward dizziness;									Y	10/23/1996	10/24/1996	1	NONE	PUB	PUB		NONE	VOR problem-doesn't track things that move;	~ ()~~~In patient		1						1	Dizziness; Nausea	FLU3~CONNAUGHT LABORATORIES~6F71226~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091380	10/28/1996	MS	58.0	58		F	10/18/1996	pt noted area of redness, warmth & tenderness about size of fifty cents piece around inj site 24hr p/vax;no resp distress, rash or other sx;									Y	10/16/1996	10/17/1996	1	examined by pub hlth nurse w/above findings noted;	PUB	PUB	Estrace & provera	NONE	NONE	~ ()~~~In patient	MS96041	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E30866A~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0091381	10/28/1996	MI	68.0	68		F	10/15/1996	PM of 10OCT96 rt arm (mid upper arm to elbow) became red & puffy & itchy-rt shoulder sore;tx w/cold compress;12OCT96 all subsided;									Y	10/10/1996	10/10/1996	0		PUB	PUB		NONE	NONE	NA~ ()~~~In patient		1						1	Oedema; Pain; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4968192~2~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~431805~1~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0091382	10/28/1996	MN	53.0	53		F	10/23/1996	flu shot rxn 8x5cm red, hot raised area;no pain;MD saw pt & advised to apply ice & ASA;									U	10/22/1996	10/22/1996	0		PVT	OTH	Premarin, Mult vit, APAP, ASA, Tenormin, Calcium supp	possible sick building synd	HTN	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71273~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091384	10/28/1996	WI	39.0	39		F	10/18/1996	15OCT96 lt upper arm soreness, jittery, h/a, nausea, joints ache, muscle aches devel shortly p/inj;cont w/sx on 16OCT96, MD notified, no tx ordered;									U	10/15/1996	10/15/1996	0	NONE	PVT	OTH	Bellergal, Fiorinal, Leve dromoran	physical exam	allergies macrodantin, pyridium, E-mycin, codeine, ponstal, naploxin, librax, sulfa, talvin, dolabid, anaprox (chronic pain synd)	NA~ ()~~~In patient		1						1	Arthralgia; Headache; Myalgia; Nausea; Nervousness; Pain	FLU3~PFIZER\WYETH~4968192~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091387	10/28/1996	FL	53.0	53		F	10/23/1996	pt recv vax 15OCT96 & 17OCT96 thumb began hurting;eventually involved lt arm which is where recv flu vax;MD believes nerve may be inflamed;Ibuprofen prescribed;thumb still hurts;									Y	10/15/1996	10/17/1996	2	NONE	MIL	MIL	NA	NONE	NONE	NA~ ()~~~In patient		1						1	Neuritis; Pain	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0091388	10/28/1996	PA	35.0	35		M	10/18/1996	pt slouched over & was unresponsive for approx 3min;pt incontinent of urine;pt then responded & stated was fine;BP 108/56, P60 regular;skin warm & clammy;AMED notified & responded;pt refused eval & stated was fine;									Y	10/18/1996	10/18/1996	0	NONE	UNK	OTH	NONE	denies	denies	NONE~ ()~~~In patient		1						1	Hyperhidrosis; Hypotonia; Stupor; Urinary incontinence; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71221~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091395	10/29/1996	MN	55.0			F	10/28/1996	pt exp extremely dizzy, room spinning, nauseated, felt like could vomit-went to ER could not find anything wrong other than elevated BP;				Y					Y					OTH	OTH	Prinivil, Hormones		high BP	~ ()~~~In patient		1						1	Condition aggravated; Dizziness; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0091396	10/29/1996	IA	62.0	62		F	10/28/1996	severe sore throat, ear infect, sinus infect, fever;									N	10/19/1996	10/21/1996	2	NONE	PUB	OTH	THYROXIN,  NADOLOL, CLARITAND,CEPHALEXIN	NONE	high BP, sulfa allergy	~ ()~~~In patient		1						1	Ear disorder; Infection; Pharyngitis; Pyrexia; Sinusitis	FLU3~PFIZER\WYETH~4968204~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091401	10/29/1996	OH	37.0	37		F	10/24/1996	approx 1/2 hr post vax pt exp flushing all over body, extreme itching & hives on legs; pt stated lips felt itchy;DPH given;BP 142/94, pulse 80;pt went to ER;				Y					Y	01/22/1996	10/22/1996	274		PUB	PVT		NONE	NKA	~ ()~~~In patient		1						1	Hypertension; Pruritus; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4968192~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091402	10/29/1996	OR	22.0	22		F	10/12/1996	felt nauseated p/shot, ate lunch, vomited, has felt lightheaded & has pain in lt arm where shot was given, extending down into elbow;cont to feel nausea & lightheadedness 2hr p/shot;									Y	10/12/1996	10/12/1996	0		OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Dizziness; Injection site pain; Nausea; Pain; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71238~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091403	10/29/1996	MO	84.0	84		F	10/24/1996	pt called office 23OCT96 stating arm red, swollen, & very painful pt instructed to call on 24OCT report progress if not improved to come to office;									Y	10/22/1996	10/23/1996	1	NA	PVT	PVT		NA	NA	~ ()~~~In patient		1						1	Oedema; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71214~6~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~438671~2~SC~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0091405	10/29/1996	AL	46.0	46		M	10/21/1996	1 1/2 hr p/vax pt c/o blurred vision;cont for about 2 1/2hr;nurse advised pt to call pvt MD;did not call MD;nurse called pt next day, doing fine & w/o any sx;reporter states pt also exp dizziness;									Y	10/18/1996	10/18/1996	0	NONE	OTH	PUB	unk	NONE	unk	~ ()~~~In patient	AL9624	1						1	Amblyopia; Dizziness	FLU3~MEDEVA PHARMA, LTD.~E2986FA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0079771	10/30/1996	IL	66.0	66		F	08/12/1996	pt recv vax & devel urticaria, for which MD prescribed Cortisone & Hismanal;face & jaw swelled to the point of disfigurement;became depressed & withdrawn & tx unsuccessfully w/ antidepressant;referred to allergist dx infect in blood;				Y					N	10/16/1995	10/30/1995	14		OTH	OTH	Synthroid, Hydralazine	NONE		~ ()~~~In patient	896241019L	1						2	Depression; Face oedema; Sepsis; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~~1~IM~~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0084095	10/30/1996	CO	24.0			F	11/06/1995	pt recv vax & w/in 2hr exp hives on face, diff breathing, wheezing & a swollen tongue;tx in ER w/DPH;sx subsided;				Y					Y	10/30/1995	10/30/1995	0		OTH	OTH	PPD given 30OCT95;			~ ()~~~In patient	950117731	1						2	Asthma; Hypersensitivity; Tongue oedema; Urticaria; Asthma; Dyspnoea; Tongue oedema; Urticaria	FLU3~PFIZER\WYETH~9458140~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~SMITHKLINE BEECHAM~1725A4~1~IM~RA~HEP B (ENGERIX-B)~1|FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEP~SMITHKLINE BEECHAM~1725A4~1~IM~RA~HEP B (ENGERIX-B)~2	USA	Emergency room visit	Influenza
0090358	10/30/1996	AR	48.0	48		F	10/12/1995	pt recv vax 10OCT95 & devel baseball sized swelling, redness, & pain @ inj site;pt also devel a fever;sx began 3-4hr post vax & gradually resolved over the next 2 days;									Y	10/10/1995	10/10/1995	0		PVT	PVT	NONE	NONE		~ ()~~~In patient	896219015L	1						2	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia	FLU3~PFIZER\WYETH~4958123~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~394963~1~IM~RA~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~4958123~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~394963~1~IM~RA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0091475	10/30/1996	NY	58.0	57		U	10/23/1996	pt recv flu vax 8OCT96 w/in a few day pt felt weak was adm to hosp on 18OCT96 & dx w/GBS by neurologist;					Y					10/08/1996	10/18/1996	10		UNK	UNK				~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome; Guillain-Barre syndrome; Myasthenic syndrome; Pain; Paralysis	FLU3~CONNAUGHT LABORATORIES~6F71255~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71255~2~SC~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0091477	10/30/1996	WV	48.0	48		F	10/29/1996	pt exp mild anaphylactic rxn rapid heart beat-diff breathing lasting approx 3min then subsiding;			Y						Y	10/16/1996	10/16/1996	0	NONE	OTH	PUB	Zantac	NONE	wasp venom	~ ()~~~In patient		1						1	Anaphylactoid reaction; Dyspnoea; Tachycardia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening	Influenza
0091479	10/30/1996	NE	54.0	54		M	10/30/1996	pt recv vax & exp diff in swallowing 6 days p/vax;pt was adm to hosp & so far the causes of the sx has not yet been identified, however GBS has been excluded;					Y	5			U	10/03/1996	10/18/1996	15	NONE	OTH	OTH	unk		MI & angioplasty, coronary artery bypass graft, fx tibia & fibula	~ ()~~~In patient	ALI96549	1						1	Dysphagia; Myalgia	FLU3~MEDEVA PHARMA, LTD.~E3106GB~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0091483	10/30/1996	NH	65.0	65		M	10/23/1996	approx 4min p/vax & w/in 1min of vax pt had an anaphylactic rxn;pt given epi, ventolin puffs, Solumedrol IV, 02 & was sent to hosp via amb for further w/u;				Y					Y	10/23/1996	10/23/1996	0	NONE	PVT	PVT	Proventil PRN, Azmacort	NONE	clam-allergy;COPD,arthritis, hyperlipidemia, diverticulosis, HTN	NONE~ ()~~~In patient		1						1	Anaphylactoid reaction; Dyspnoea	FLU3~PARKE-DAVIS~00276P~5~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~0001D~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0091487	10/30/1996	MD	39.0	39		F	10/25/1996	pt recv vax 22OCT96 720AM & exp itching & lt upper arm began 23OCT96 6PM-7PM;became red, warm to touch & induration was noticed on 24OCT96;itching cont on 25OCT96 erythema is 9.5cm diameter;felt flushed 24OCT96;									N	10/22/1996	10/23/1996	1		PUB	PUB	Ventolin inhaler, Asthmacort inhaler	NONE	allergies, mold, pollen, sulfites, asthma;	pt exp soreness w/MMR vax # 36yr~ ()~~~In patient	MD96049	1						1	Injection site hypersensitivity; Injection site mass; Pruritus; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3046GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0091488	10/30/1996	TX	61.0	61		M	10/22/1996	began feeling bad about 24hr p/vax;Sunday AM felt very bad, aches-no appetite;Sunday noon-nauseated-vomiting lasting until Monday AM;Tuesday-feels ok-just weak;									Y	10/18/1996	10/19/1996	1		PUB	PUB	Lescol, Motrin, ASA	NONE	high cholesterol;2 heart attacks & by-pass surgery x 2;	NONE~ ()~~~In patient	TX96175	1						1	Anorexia; Asthenia; Malaise; Myalgia; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71275~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091492	10/30/1996	UT	34.0	34		F	10/07/1996	4OCT96 pt recv vax & 5OCT96 exp red, swollen, hot to touch, fever;swelling for a wk, itched, small bruise;21OCT hard lump now;no other c/o or problems @ this time;fever lasted over weekend only;									Y	10/04/1996	10/05/1996	1	NONE	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	UT961821	1						1	Ecchymosis; Oedema; Pruritus; Pyrexia; Skin nodule; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3106GC~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~CONNAUGHT LABORATORIES~6F81202~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0091493	10/30/1996	UT	23.0	22		F	10/21/1996	4OCT96 arm became sore 5OCT96 arm touched pt became nauseated; called MD instructions to do hot & cold pack;devel fever of 101 5OCT;21OCT96 arm still has hard bump;when pressed on arm goes numb;									U	10/04/1996	10/05/1996	1	NONE	OTH	PVT	Birth control pills	NONE	denies any	NONE~ ()~~~In patient	UT961823	1						1	Myalgia; Nausea; Paraesthesia; Pyrexia; Skin nodule	FLU3~MEDEVA PHARMA, LTD.~E31066C~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~CONNAUGHT LABORATORIES~6F81202~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0091494	10/30/1996	UT	53.0	53		F	10/27/1996	4OCT96 pt recv vax 5OCT96 arm sore & swollen;arm sore for 2wk;									Y	10/04/1996	10/05/1996	1	NONE	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	UT961822	1						1	Myalgia; Oedema peripheral	FLU3~MEDEVA PHARMA, LTD.~E3106GC~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~CONNAUGHT LABORATORIES~6H81269~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0091495	10/30/1996	KS	35.0	35		M	10/17/1996	reddened area, raised & firm formed immed upon inj of flu vax;no report of diff breathing, itching or feeling of apprehension;bleeding @ inj site;									Y	10/10/1996	10/10/1996	0	NA	OTH	PVT	unk	NONE	NONE	unk~ ()~~~In patient		1						1	Haemorrhage; Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~PFIZER\WYETH~4968172~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091497	10/30/1996	FL	38.0	38		F	10/25/1996	210PM 4hr p/vax pt c/o h/a, nausea @ first; AP 80, BP 130/80;approx 240PM pt still c/o above sx; BP 120/80, AP 80 & pt then began to have lt deltoid itching w/tingling in feet;911 called;pt states the same & w/itching given epi;				Y					U	10/18/1996	10/18/1996	0		OTH	OTH	unk @ time of inj	pt denied any active infect	pt stated @ 3Pm has hx of migraines	not known @ time of inj~ ()~~~In patient		1						1	Headache; Nausea; Paraesthesia; Pruritus	FLU3~CONNAUGHT LABORATORIES~6F71273~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091501	10/30/1996	PA	41.0	41		F	10/21/1996	inflammation @ inj site persisting for wk;redness, swelling, pain, tenderness, induration lasting more than 16 days;				Y						10/04/1996	10/06/1996	2	NONE	PVT	PVT	NONE	NONE	prior reactions ot erythromycin & floxin	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site inflammation; Injection site mass; Injection site oedema; Injection site pain; Arthralgia; Hypokinesia; Insomnia; Oedema; Pain; Skin discolouration; Vasodilatation	FLU3~PARKE-DAVIS~01286P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~01286P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~PFIZER\WYETH~436122~1~~RA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0091506	10/30/1996	WV	38.0	38		F	10/23/1996	dizziness, nausea, sweatiness, feeling high, transient lt chest pain;sx persisted @ least 4hr but are improving gradually;throat felt swollen;nl exam;no hives or wheezing;had hematoma @ site;				Y					U	10/23/1996	10/23/1996	0	CBC, chem 7, CXR nl;	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Chest pain; Dizziness; Euphoric mood; Hyperhidrosis; Injection site haemorrhage; Laryngospasm; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0091507	10/30/1996	WV	32.0	32		M	10/23/1996	light headedness & chills in 30';throat swelling feeling in 1hr, sx improved but not gone in 4hr;no hives or wheezing;									U	10/23/1996	10/23/1996	0	CBC & chem 7 nl	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Chills; Dizziness; Laryngospasm	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0091509	10/30/1996	IA	49.0	49		F	10/17/1996	pt recv vax & states had burning & stinging when administered;10 min later had head-rash-felt like blood rushing to head & back again;had vision problems BP 158/90; 15min later BP 130/80 vision OK;cont to have head rashes;h/a & blahs										10/16/1996	10/16/1996	0		PUB	OTH	Pondimin, Premarin, Furosemide, vasotec, ionamin	NONE	high BP	NONE~ ()~~~In patient		1						1	Headache; Hypertension; Injection site pain; Malaise; Visual disturbance	FLU3~PFIZER\WYETH~4968189~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091512	10/30/1996	IA	5.0	5		M	10/19/1996	pt recv flu vax & was given APAP because said arms hurt;then had a fever ranging from 100.2 to 102.3;APAP only tx;									Y	10/11/1996	10/15/1996	4		PVT	OTH		NONE	mild cerebral palsy in legs, arms, & hands;wears AFOS & walks w/arm cuff crutches	~ ()~~~In patient		1						1	Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~~UNK~~~VARICELLA (VARIVAX)~1	USA		Influenza
0091515	10/30/1996	CA	15.0	15		M	10/10/1996	several hr following vax pt devel non-itchy rash w/no diff breathing, no SOB;				Y					Y	10/02/1996	10/02/1996	0	NONE	OTH	PUB	pt recv TD vax from Ldedrle lot# 428476 given 19OCT96;		hx asthma	denies~ ()~~~In patient		1						1	Rash	FLU3~CONNAUGHT LABORATORIES~6F71212~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091516	10/30/1996	MA	8.0	8		F	10/09/1996	pain, swelling, redness & itching @ inj site;									Y	10/07/1996	10/07/1996	0	NONE	PVT	PUB		healthy	immunocompromised	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus	FLU3~CONNAUGHT LABORATORIES~6F71226~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091518	10/30/1996	KY	61.0	61		F	10/23/1996	approx 3-4 hr p/inj 21OCT96 pt exp soreness lt deltoid w/redness, induration & warmth on 22OCT96; examined by MD started on ATB;				Y						10/21/1996	10/21/1996	0		PVT	OTH		NONE	septra, HTN, COPD, DJD	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~PARKE-DAVIS~4968141~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~431803~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0091519	10/30/1996	MO	22.0	22		M	10/22/1996	approx 15min p/vax devel SOB, severe itching, hives, diaphoresis, feeling like throat closing;given epi & DPH, & Solucortef				Y					Y	10/09/1996	10/09/1996	0		OTH	PVT	NONE	NONE	NONE	unk~ ()~~~In patient		1						1	Dyspnoea; Hyperhidrosis; Laryngospasm; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4968168~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091520	10/30/1996	MO	77.0	77		F	10/22/1996	urticaria, heaviness w/breathing;				Y					Y	10/08/1996	10/08/1996	0	resp tx;	PUB	PVT	unk	NONE	allergy to some preservatives	~ ()~~~In patient		1						1	Dyspnoea; Urticaria	FLU3~PFIZER\WYETH~4968168~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091522	10/30/1996	NY	41.0	41		F	10/25/1996	pale, diaphoretic, felt throat closure-911 called;transported to ER;BP prior to transport 110/78;given epi by RN;				Y					U	10/24/1996	10/24/1996	0	NONE	OTH	OTH			SLE-lupus	~ ()~~~In patient		1						1	Hyperhidrosis; Hypotension; Laryngospasm; Pallor	DT~CONNAUGHT LABORATORIES~6H81269~2~~~DT ADSORBED (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~6F71237~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091523	10/30/1996	WI	38.0	38		M	10/22/1996	asthma, pharyngitis, conjunctivitis;				Y					Y	10/08/1996	10/08/1996	0		OTH	PVT	Inhaler, DPH in ER			pt exp asthma, pharyngitis, conjunctivitis in 1976 @ 28yr w/flu vax;~ ()~~~In patient		1						1	Asthma; Conjunctivitis; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~6F71288~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091524	10/30/1996	OH	50.0	50		F	10/23/1996	woke up from sleep d/t diff breathing-wheezing, sore throat, nose running, made sounds from chest wheezing tingling to get air 250AM shaking from chills;330AM running temp;545AM t100.8;took ASA; eyes (white part) were pink;									Y	10/16/1996	10/16/1996	0		OTH	OTH	Daily vitamin, vitamin B	NONE	NONE	~ ()~~~In patient		1						1	Asthma; Chills; Conjunctivitis; Dyspnoea; Pharyngitis; Pyrexia; Rhinitis; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0091525	10/30/1996	WI	41.0	41		F	10/25/1996	puffiness about 1hr p/inj;arm ached; 3 x 2 welt across upper arm;redness under arm;next day 2x6: welt;entire arm very sore;put on Doxycycline;				Y					Y	10/14/1996	10/14/1996	0		PVT	PVT	NONE	NONE	NONE	pt exp sore arm w/flu vax;~ ()~~~In patient		1						1	Myalgia; Oedema; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4968156~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091526	10/30/1996	WA	58.0	58		M	10/21/1996	several hr p/vax pt began having scratchy throat & cough, joint pains lasted 2 days;cough productive of yellow sputum;no inc temp;+chest x-ray RLL pneumonia-started on med unable to complete med d/t upset stomach;				Y					Y	10/03/1996	10/03/1996	0	CXR	PVT	PVT	ASA, Tenormin	NONE	PCE-gastritis (discovered when given on 7OCT96);	~ ()~~~In patient		1						1	Arthralgia; Cough; Dyspepsia; Infection; Pharyngitis; Pneumonia	FLU3~CONNAUGHT LABORATORIES~6F71320~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091527	10/30/1996	CO	48.0	48		F	10/21/1996	rash, lump under rt arm;lump still their 22OCT96;sick, itching, aching in joints;									Y	10/18/1996	10/18/1996	0		PVT	PVT	NA	NA	asthma	~ ()~~~In patient		1						1	Arthralgia; Malaise; Pruritus; Rash; Skin nodule	FLU3~MEDEVA PHARMA, LTD.~E3036GA~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0091528	10/30/1996	CO	31.0	31		F		arm swelling, rash, itching,aching in joints;DPH for itching;									Y	10/18/1996	10/18/1996	0		PVT	PVT		NONE		~ ()~~~In patient		1						1	Arthralgia; Oedema; Pruritus; Rash	FLU3~MEDEVA PHARMA, LTD.~E3036GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0091529	10/30/1996	WA	49.0	49		U		pt reported the evening following vax became ill, n/v, chills, unk fever (didn't have thermometer) lasted7PM-2A;doing fine next day;									Y	10/22/1996	10/22/1996	0		PVT	PVT		alcoholic cirohosis	NKA;chronic low back pain;	~ ()~~~In patient		1						1	Chills; Malaise; Nausea; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~00886P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0091531	10/30/1996	MO	70.0	70		F	10/22/1996	reported measles like rash on arm & back noted about 5hr p/vax;pt stated exp similar rash p/pneumo vax in MAY96;									Y	10/09/1996	10/09/1996	0	NA	OTH	PVT	unk	NONE	reported multiples allergies none contraindicated vaccine	unk~ ()~~~In patient		1						1	Rash maculo-papular	FLU3~PFIZER\WYETH~4968203~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091532	10/30/1996	MO				M	10/15/1996	reported itching & soreness @ site of inj;onset 24hr p/vax;instructed to take APAP as needed & to use ice pack to site;									Y	10/11/1996	10/12/1996	1	NA	OTH	PVT	NONE	unk	unk	unk~ ()~~~In patient		1						1	Injection site pain; Pruritus	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091533	10/30/1996	KS	61.0	60		F	10/22/1996	reported welt size of palm @ inj site lt arm;feverish & red @ site & itches;noted on morning 10OCT96;self treated by cleaning & applied lotion;									U	10/09/1996	10/10/1996	1	NA	OTH	PVT	unk	NONE	unk	unk~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4968172~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091537	10/30/1996	WI	42.0	42		F	10/25/1996	arm got red, swollen, warm;became 6 diameter;saw MD 4 days p/inj & put on med;				Y					Y	10/14/1996	10/14/1996	0		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Oedema; Vasodilatation	FLU3~PFIZER\WYETH~4968156~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091538	10/30/1996	UT	38.0	38		F		pt stated had mucosal membrane rash, w/arthralgias;pt referred to hlth dept;pt called back & referred to own MD;									U	10/12/1996	10/13/1996	1		PUB	PVT		NONE	UNK	~ ()~~~In patient		1						1	Arthralgia; Rash; Skin nodule	FLU3~CONNAUGHT LABORATORIES~6F71289~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091541	10/30/1996	TN	63.0	63		F	10/12/1996	warm, localized itching-appeared swelling/mild until sleeve which was rolled up & tight, was lowered & cool pack applied, this resolved;some mild itching top  of head w/inc BP common 160/120, which dec 5min to 160/94, HR 86 reg;				Y					Y	10/12/1996	10/12/1996	0		OTH	PVT	allergy & HTn	HTn	allergies/allergist told pt to get flu shot	NONE~ ()~~~In patient		1						1	Condition aggravated; Oedema; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71275~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091543	10/30/1996	WA	41.0	41		F	10/23/1996	pt came by amb p/tonic clonic sz;no sz activity p/arrival to hosp;				Y					Y	10/22/1996	10/23/1996	1	CT head;CBC SMAC, EKG, CXR	OTH	OTH	Suphedrine, Pred, Buspar Hyciroxy, PAM 25, Diphenoxylate w/atropine			~ ()~~~In patient		1						1	Convulsion	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0091546	10/30/1996	VA	42.0	42		F	10/23/1996	bright red shoulder @ inj site, w assoc swelling cervical & axillary adenopathy extremely painful;sx x 1wk;breast pressure (swollen) x 3wk;pt did not notify until p/event;									Y	09/12/1996	09/13/1996	1	NONE	PVT	PVT	Porventil inhalger	NONE	seasonal allergies (environmental), asthma	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Lymphadenopathy; Oedema	FLU3~CONNAUGHT LABORATORIES~6F71289~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091691	10/30/1996	TX	60.0	60		F	09/19/1996	pt recv vax 7 12 to 15hr later pt devel flu sx including fever, chills, diarrhea, h/a & sore throat;pt was unable to get out of bed for 2 days;									Y	09/17/1996	09/17/1996	0		OTH	OTH	NONE	unk		NONE~ ()~~~In patient	896270027L	1						1	Chills; Diarrhoea; Headache; Hypokinesia; Influenza; Pharyngitis; Pyrexia	FLU3~PFIZER\WYETH~4968161~7+~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091692	10/30/1996	TX				U	09/25/1996	nurse reported that approx 50% of individuals who recv flu vax @ this site devel inj site rxn characterized by pain, swelling, or warmth;no further info was available @ the date of this report;									U					PVT	OTH	unk	NONE		~ ()~~~In patient	896275003L	1						1	Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4968146~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091693	10/30/1996	AK	40.0	39		F	09/27/1996	pt recv vax & devel lt axillary lymphadenopathy;pt has been exp lt ax pain, which radiates to the lt breast;reporter attributed the pain to the lymphadenopathy;									Y	09/23/1996	09/26/1996	3		OTH	OTH	Prozac	NONE		~ ()~~~In patient	896275012L	1						1	Breast pain; Lymphadenopathy; Pain	FLU3~PFIZER\WYETH~~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091694	10/30/1996	CA	53.0	53		F	02/08/1996	24hr post vax pt devel severe pain in rt arm;next day pain spread to the hips, back & shoulder & c/o fever, noc sweats & loss of mobility in rt arm;tx w/Ibuprofen w/o relief;1mo later erythrocyte sedimentation rate 125;joint pain									U	10/19/1995	10/20/1995	1	1mo post vax ESR 125;	PVT	PVT	conjugated estrogens;spironolactone	NONE	migraine, hypertension, menopause	~ ()~~~In patient	896191006L	1						1	Arthralgia; Back pain; Hyperhidrosis; Hypokinesia; Injection site oedema; Pain; Pyrexia; Red blood cell sedimentation rate increased	FLU3~PFIZER\WYETH~4958120~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1076B~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0091695	10/30/1996	WA	52.0	52		F	06/25/1996	pt recv vax & exp urticaria & swelling of the lips & eyes;cont to exp urticaria as of the date of this report;				Y					Y	12/08/1995	12/09/1995	1		OTH	OTH	unk	NONE	penicillin allergy, arthritis, chronic sinusitis, probable MS	~ ()~~~In patient	896191009L	1						1	Face oedema; Pain; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0091698	10/30/1996	MI	48.0	48		F	09/25/1996	pt recv vax & w/in 24hr devel inj site rxn characterized by swelling, tenderness, & erythema;tx w/DPH & sx resolved w/in hr;									Y	12/21/1995	12/22/1995	1		PVT	OTH	Colchicine	pancytopenia secondary to myelodysplasia	allergic to IV contrast dye; myelodysplasia; awaiting bone marrow transplant	~ ()~~~In patient	896275002L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0091834	10/31/1996	PA	41.0			F	10/22/1996	pt recv vax & exp lt arm soreness, redness & swelling & arm was hot to touch;pt has not been able to move arm up & out (abduction) from body for 13 days;pt tx w/Ibuprofen w/some pain relief;scheduled for an appointment w/MD 18OCT96;				Y					N	10/04/1996	10/04/1996	0	unk	PVT	OTH	Premarin, Synthroid	NONE	not allergic to eggs, NKDA	~ ()~~~In patient	0010150960035	1						1	Hypokinesia; Injection site inflammation; Injection site pain; Movement disorder; Myalgia; Oedema; Pain; Vasodilatation	FLU3~PARKE-DAVIS~01286P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0091837	10/31/1996	GA	35.0	35		F	10/18/1996	erythema & swelling x 3 days 4 1/2cm diameter;									Y	10/03/1996	10/04/1996	1	NONE	PVT	PVT		NONE	cardiomyopathy/breast Ca	~ ()~~~In patient		1						1	Oedema; Rash	FLU3~PFIZER\WYETH~4968173~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091838	10/31/1996	GA	39.0	39		F	10/18/1996	local reaction;red & warm to touch;									U	10/17/1996	10/18/1996	1		PVT	PVT		NONE	GERD, IBS	~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PFIZER\WYETH~4968173~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091839	10/31/1996	GA	75.0	75		F	10/18/1996	local rxn;swelling redness & warm to touch around inj site;									U	10/16/1996	10/17/1996	1		PVT	PVT		NONE	hypothyroidism	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4968173~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091842	10/31/1996	ND	71.0	70		F	10/22/1996	burning @ inj site;erythema & vesicles @ site;									Y	10/18/1996	10/18/1996	0		PVT	PVT		NONE		~ ()~~~In patient	ND96021	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4968178~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091843	10/31/1996	FL	76.0	76		F	10/25/1996	pt recv vax 21OCT96 10AM & 12hr later devel redness, swelling & itchy area around inj site;saw MD & was placed on Augmentin;				Y						10/21/1996	10/21/1996	0	NA	PUB	OTH	Potassium, Darcil, glucofag, THyroid, GLidizide	NONE	diabetes, hyperthycoidism	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~MEDEVA PHARMA, LTD.~E3106HB~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0091439	11/01/1996	NJ	44.0	44		F	10/28/1996	11AM felt like could not breathe-throat constricted;blacked out while driving car;came to by 11:05 but blacked out 2 more times;felt sick until 2PM that day;			Y						Y	10/22/1996	10/22/1996	0	NONE	PUB	UNK	NONE	NONE	allergy to sulfa & PCN;	NONE~ ()~~~In patient		1						1	Dyspnoea; Laryngospasm; Malaise; Syncope	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0091441	11/01/1996	PA	47.0	47		M	10/28/1996	pt became diaphoretic, lightheaded, dizzy w/soreness in joints, sl heaviness in chest & SOB relieved w/02, ntg, IV NS;	Y	10/28/1996							N	10/28/1996	10/28/1996	0	EKG-nl sinus thythm-nl ECG;	MIL	MIL	NONE	NONE	HTN	~ ()~~~In patient		1						1	Chest pain; Dizziness; Dyspnoea; Hyperhidrosis; Hypoxia; Myalgia; Cardiac arrest; Chest pain; Convulsion; Dizziness; Dyspnoea; Hyperhidrosis; Pain	FLU3~PFIZER\WYETH~4968202~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968202~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Results in Death	Influenza
0091442	11/01/1996	MI	78.0	78		M	10/11/1996	3OCT vomiting;4OCT diarrhea;5OCt ER x-rays;6OCT hosp x 2 days;dx stomach ulcer, high BP, arthritis & severe skin problem;				Y	Y	2			Y	10/02/1996	10/03/1996	1		PVT	PVT	Reefen, Theophilin, Probenicin			~ ()~~~In patient	MI96148	1						1	Arthritis; Diarrhoea; Gastric ulcer; Hypertension; Skin disorder; Vomiting	FLU3~PARKE-DAVIS~01066P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0091445	11/01/1996	MI	43.0	43		F	10/21/1996	15min p/vax while on route home, pt exp dizziness, flushing, sweating & feeling funny;sx still present 4hr later;advised to call MD;sent to ER for eval;tx w/DPH & steroid;				Y					Y	10/18/1996	10/18/1996	0		PUB	PUB				pt had flu vax years ago w/sl rxn;~ ()~~~In patient	MI96144	1						1	Dizziness; Hyperhidrosis; Personality disorder; Vasodilatation	FLU3~PFIZER\WYETH~496813~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091446	11/01/1996	MI	30.0	30		F	10/10/1996	pt recv vax 9OCT96 230PM & 5hr later pt felt sick, redness & swelling (dime size) @ site-very painful;pain in lower back & under rib area in chest;started menstrual period 1wk early;t102.0 9OCT, 10OCT t101.0, cant, eat d/t stomach pain									Y	10/09/1996	10/09/1996	0	NONE	PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	MI96145	1						1	Abdominal pain; Back pain; Chest pain; Injection site hypersensitivity; Injection site oedema; Injection site pain; Malaise; Pyrexia	FLU3~PFIZER\WYETH~4968172~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091448	11/01/1996	MI	38.0	38		M	10/17/1996	10AM pt recv vax on 14OCT96 & exp chills & fever (feet hot) & muscle aches;these s/s subsided 16OCT96;16OCT noticed rt arm got hot to touch & devel deep red circle 3 & puffy;pt to call own MD to recv further instructions;arm still aches;									Y	10/14/1996	10/15/1996	1	NONE	PUB	PUB	diabetic	NONE	DM	~ ()~~~In patient	MI96149	1						1	Chills; Injection site hypersensitivity; Injection site oedema; Myalgia; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4968172~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~428504~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0091449	11/01/1996	MI	55.0	55		F	10/15/1996	pt recv vax 11OCT96 & states arm became warm to touch & swollen below inj site @ 2 below elbow;felt chills on 12OCT96 but did not take temp;states has arthritis in rt elbow;has not had pneumovax in past;arm still sore;									Y	10/11/1996	10/12/1996	1		PUB	PUB	Prevacid, Synthroid-Entax LA;Librax-Codiene		borderline diabetes/had TB as a child	~ ()~~~In patient	MI96150	1						1	Chills; Myalgia; Oedema; Vasodilatation	FLU3~PFIZER\WYETH~4968172~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~428504~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0091451	11/01/1996	WI	40.0	40		F	10/15/1996	pt recv vax 1OCT96 & by evening 2OCT lt arm (upper) was sore & warm;3OCT whole lt arm painful-couldn't wear watch;ROM limited;upper arm reddened & edematous;tx meds, dx cellulitis;				Y					Y	10/01/1996	10/02/1996	1		OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Cellulitis; Hypokinesia; Myalgia; Oedema; Pain; Vasodilatation	FLU3~PARKE-DAVIS~00376P~2~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0091453	11/01/1996	MN	41.0	41		F	10/28/1996	lt hand became numb shortly p/vax;									Y	10/15/1996	10/15/1996	0		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Paraesthesia	FLU3~CONNAUGHT LABORATORIES~6F71278~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091458	11/01/1996	FL	40.0	40		F	10/24/1996	pt recv vax 17OCT96 & devel itching & swelling all over body & eyelids the following day;went to MD who prescribed Pred;				Y					Y	10/17/1996	10/18/1996	1		PUB	PUB	Adalat			~ ()~~~In patient	FL96073	1						1	Face oedema; Generalised oedema; Pruritus	FLU3~PFIZER\WYETH~6F71277~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091555	11/04/1996	CA	56.0	56		F	10/15/1996	pt recv vax 1PM 21SEP96 & later had an eye exam & went home;about 4PM took a nap;around 5PM woke up lt ear was ringing loudly about 6PM pt daughter called & pt stated could not hear at all from left ear;								Y	N	09/21/1996	09/21/1996	0	MRI, ear exam, blood work	OTH	PVT	Premarin	NONE	NONE	~ ()~~~In patient		1						1	Deafness; Tinnitus	FLU3~PFIZER\WYETH~4968188~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0091559	11/04/1996	CA	46.0	46		F	10/25/1996	pt recv flu vax 7OCT96 & 10OCT96 pt had severe neck, head & back pain w/inc WBC & fever;adm to hosp w/dx viral meningitis;				Y	Y				Y	10/07/1996	10/10/1996	3		PVT	PVT	unk	NONE	hx chronic sinusitis, allergic PCN, tomatoes	~ ()~~~In patient		1						1	Back pain; Headache; Infection; Leukocytosis; Meningitis; Neck pain	FLU3~PFIZER\WYETH~4968265~3~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0091560	11/04/1996	WA	52.0	52		F	10/29/1996	w/in 24hr sore throat, aches, runny nose;pt states poss it was a big coincidence?; pt states throat & runny nose, sore arm & aches were there in AM;									Y	10/19/1996	10/20/1996	1	NONE	PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	WA971361	1						1	Myalgia; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0091562	11/04/1996	MN	42.0	42		F	10/30/1996	pt recv vax & became pale white in color;no obvious resp distress;oriented x3;pt reported face was flushed;pt comfortable on knees;exp full feeling in throat;pt later went to MD who states poss d/t recent illness;				Y					Y	10/30/1996	10/30/1996	0		PUB	PUB	amoxicillin	reported recovery from resp;illness	NONE	~ ()~~~In patient	MN97031	1						1	Laryngospasm; Pallor; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~4968163~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~CONNAUGHT LABORATORIES~6HB1269~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0091564	11/04/1996	CO	35.0	35		F	10/24/1996	pt c/o sweating, feeling lightheaded, 20-25 min p/vax;resp 18 nl, BP 140/80, P80;pt sweating profusely, cool towel applied to forehead, pt lay down on sofa, Vs retaken & same as above 911 called & pt taken to ER to be seen by MD;				Y					Y	10/23/1996	10/23/1996	0	NOT KNOWN	OTH	PVT	Phen-phen	NONE	bee stings	~ ()~~~In patient		1						1	Dizziness; Hyperhidrosis	FLU3~CONNAUGHT LABORATORIES~6F71321~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091566	11/04/1996	MO	60.0			F	10/22/1996	pt recv vax & 2-3 hr later had rash w/whelps & itching;denies breathing diff or other sx;				Y					Y	10/21/1996	10/21/1996	0		PUB	PUB		NONE	NONE	~ ()~~~In patient	MO96062	1						1	Pruritus; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71288~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091567	11/04/1996	FL	61.0	61		F	10/24/1996	approx 4hr p/vax rt arm started to be painful, swollen, & diff to move especially from elbow down to fingers;took med, warm compresses;pain mostly from elbow to upper arm;ATB prescribed by MD & cont warm compresses/soaks;				Y						10/23/1996	10/23/1996	0		OTH	PUB	Prilosec, Estrace, Medroprogesterone			~ ()~~~In patient	FL96074	1						1	Hypokinesia; Oedema; Pain	FLU3~CONNAUGHT LABORATORIES~6F71306~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1627B~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0091573	11/04/1996	CA	59.0	59		F	10/25/1996	pt recv vax 16OCT96 & 18OCT96 3AM pt awoke w/achy joints until 23OCT96 denies any other c/o;				Y					Y	10/16/1996	10/18/1996	2	NONE	PUB	PVT	Minipress, Lasix, Voltaren, Vicodin	NONE	arthritis, HTn, allergic to sulfa drugs	~ ()~~~In patient		1						1	Arthralgia	FLU3~PFIZER\WYETH~4968187~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091574	11/04/1996	CA	30.0	29		M	10/28/1996	pt c/o severe flu sx 2 days p/vax;t101, body aches, severe sore throat, nasal congestion, cough & fatigue;				Y					U	10/23/1996	10/25/1996	2	NONE	OTH	PVT	NONE	NONE	JUN96 bilat L5 spondyloysis	~ ()~~~In patient		1						1	Asthenia; Cough; Influenza; Myalgia; Pharyngitis; Pyrexia; Rhinitis	FLU3~PFIZER\WYETH~6F71224~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091586	11/04/1996	CO	56.0	56		F	10/18/1996	lt deltoid is sore, very red, swollen around the inj site;size of baseball-area hard & warm to touch;									Y	10/16/1996	10/16/1996	0	NONE	OTH	PUB		NONE		~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71321~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091589	11/04/1996	CA	35.0			F	10/30/1996	pt recv vax spotty erythema & itching;small vesicle @ inj site 2 days p/vax;									Y				NONE	OTH	PVT	APAP	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~6F71215~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091591	11/04/1996	CA	55.0	55		F	10/30/1996	inj site red & swollen;feeling of fatigue & achy joints x 2 days;local symptomatic									Y	10/28/1996	10/29/1996	1	NONE	OTH	PVT	Proventil	Emphysema	PCN	~ ()~~~In patient		1						1	Arthralgia; Asthenia; Injection site hypersensitivity; Injection site oedema; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~6F71215~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091594	11/04/1996	WI	38.0	38		F	10/28/1996	for 3 days p/vax pt was very stiff all over body but mainly lower body, had h/a, nausea & was very tired, had frequent BM's, had eye irritation, burning & itching;									Y	10/23/1996	10/24/1996	1	NONE	PVT	PVT	Ibuprofen	NONE	NONE	pt exp muscle stiffness, nausea, fatigue OCT95 w/flu vax;~ ()~~~In patient		1						1	Asthenia; Conjunctivitis; Diarrhoea; Eye pain; Headache; Hypertonia; Nausea; Pruritus	FLU3~CONNAUGHT LABORATORIES~6F71307~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091595	11/04/1996	WI	47.0	47		F	10/28/1996	tired enough to take naps;nausea, burning eyes;									Y	10/23/1996	10/24/1996	1		PVT	PVT	Vitamins, Zantac	NONE	HTN, irregular heart beat, hypoglycemia	NONE~ ()~~~In patient		1						1	Asthenia; Eye disorder; Nausea	FLU3~CONNAUGHT LABORATORIES~6F71307~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091598	11/04/1996	IL	67.0	67		F	10/15/1996	nausea, h/a, tremors, body ache all over, chest aching, rash blister like on lt arm moving onto shoulder;pt dx w/herpes zoster non vax related by MD;									Y	10/08/1996	10/09/1996	1		PUB	PUB	Halopurinol, Zanex, Magnasium, Reliphin, Calcium D, Potassium, Zilopriimi	NONE		NONE~ ()~~~In patient	IL960101	1						1	Chest pain; Dermatitis bullous; Headache; Herpes zoster; Myalgia; Nausea; Tremor	FLU3~CONNAUGHT LABORATORIES~6F71307~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091601	11/04/1996	AZ	28.0	28		F	10/28/1996	woke up 8AM on 13OCT96 w/t101, very fatigued all day, severe body aches, dry, tight cough, sore throat & dec appetite;sx were worse around noon & gradually dec over next 10-12hr;inj site red, swollen, sore x 36hr p/vax;									Y	10/12/1996	10/13/1996	1	NONE	PVT	PVT	Relafen for shoulder pain	NONE	allergic to Augmentin;mild asthma rt shoulder strain;	NONE~ ()~~~In patient		1						1	Anorexia; Asthenia; Cough; Injection site hypersensitivity; Injection site oedema; Myalgia; Pharyngitis; Pyrexia	FLU3~PARKE-DAVIS~00596P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0091602	11/04/1996	MN	52.0	52		F	10/23/1996	30 days p/vax pt malaise;had tenderness in lt arm;tenderness remains unchanged;no palpable hematoma, no redness, no swelling;									N	10/09/1996	10/12/1996	3	NONE	PUB	OTH	Insulin-Velosin,Humulin buffered	diabetes-chronic	diabetes-1962-present, allergies-amoxicillin (severe vomitting), Reglan	~ ()~~~In patient	MN96040	1						1	Malaise; Myalgia	FLU3~PFIZER\WYETH~4968167~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091606	11/04/1996	MN	69.0	69		F	10/21/1996	pt recv vax 16OCT96 & reported fatigue, emesis & diarrhea that noc;no sx 24hr later;									Y	10/16/1996	10/16/1996	0		PVT	PVT		NONE	No allergies	~ ()~~~In patient		1						1	Asthenia; Diarrhoea; Vomiting	FLU3~PFIZER\WYETH~4968168~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091607	11/04/1996	CA	7.0	7		M	10/28/1996	pt recv vax 9OCT96 & bell's palsy 24OCT96;rt facial paralysis;									N	10/09/1996	10/24/1996	15	CBC WNL	PVT	PVT	Azmacort	NONE	asthma	NONE~ ()~~~In patient		1						1	Facial palsy	FLU3~CONNAUGHT LABORATORIES~671289~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091616	11/05/1996	MN	68.0	68		F	10/29/1996	hosp reported pt had poss rxn from flu shot, requesting lot# & MFR;reports that pt exp GBS type sx, weakness, was intubated & on ventilator;limited info recv;pt currently in hosp;					Y				U	10/09/1996	10/29/1996	20		PUB	PUB		NONE	NONE	~ ()~~~In patient	MN96042A	1						1	Apnoea; Asthenia; Guillain-Barre syndrome; Anorexia; Back pain; Guillain-Barre syndrome; Headache; Mouth ulceration; Myasthenic syndrome; Vomiting	FLU3~PFIZER\WYETH~4968163~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968163~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0091621	11/05/1996	KY	24.0			M	10/16/1996	pt recv vax & devel a sore throat, pleuritic chest pain, fever, hyperbilirubinemia, & elevated liver function tests;pt hosp;					Y				U	10/14/1996				OTH	OTH	unk	NONE		~ ()~~~In patient	896292009L	1						1	Chest pain; Hepatic function abnormal; Hyperbilirubinaemia; Pharyngitis; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0091623	11/05/1996	NH	96.0	96		F	10/24/1996	pt recv vax 16OCT96 & devel a low grade temp of 99.5;18OCT96 pt devel rales in both lobes, a BP of 90/40, periods of apnea lasting 3 to 4 sec & sleepiness alternated w/restlessness;pt died on 19OCT96;reporter states pt health had been	Y	10/19/1996	Y						N	10/16/1996	10/18/1996	2	NONE PROVIDED;	PVT	OTH	Verapamil, Percocet	NONE	hx of HTN, dementia, arthritis, vaginosis, atrial flutter, NKA;	~ ()~~~In patient	0010150960037	1						1	Agitation; Apnoea; Hypotension; Lung disorder; Pulmonary oedema; Pyrexia; Right ventricular failure; Somnolence	FLU3~PARKE-DAVIS~00986P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0091624	11/05/1996	FL	71.0	71		M	10/31/1996	pt adm w/GBS possibly assoc w/flu vax 2wk prior to admission;ascending neuromuscular deficits noted 2 days prior to admission-h/a 3 days prior to admission;			Y		Y				Y	10/01/1996	10/24/1996	23	28OCT96 LP 177.7;	UNK	UNK	Orthopedic surgery 2SEP96 w/anesthesia;			~ ()~~~In patient		1						1	CSF test abnormal; Guillain-Barre syndrome; Headache; Myopathy; Neuropathy	FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation	Influenza
0091626	11/05/1996	NY	47.0	47		M	10/24/1996	sterile abscess lt arm;				Y				Y	U	10/14/1996	10/23/1996	9	.NONE	PVT	PVT		NONE	NONE	NA~ ()~~~In patient		1						1	Abscess	FLU3~CONNAUGHT LABORATORIES~6F71292~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~GC81110~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Disabling	Influenza
0091627	11/05/1996	NH	63.0	63		M	10/30/1996	throat tightening, SOB, pallor, diaphoresis, lethargy; epi given w/immed relief;			Y	Y					Y	10/16/1996	10/16/1996	0		OTH	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Dyspnoea; Hyperhidrosis; Laryngospasm; Pallor; Somnolence	FLU3~PFIZER\WYETH~4968173~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening	Influenza
0091631	11/05/1996	MA	40.0	40		M	10/24/1996	pt recv vax 8OCT96 &  noted earache, tingling feeling lt side of face;was seen @ hosp probable Bell's Palsy seen in office 10OCT96 confirmed lt sided Bell's palsy;initial lyme test in ER was reported as negative;				Y					Y	10/08/1996	10/09/1996	1	Lyme test negative;	UNK	UNK	Glucatrol, Cardura, Calan SR		DM, HTN, cockroaches, ragweed	~ ()~~~In patient		1						1	Ear pain; Facial palsy; Myasthenic syndrome; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E3026GB~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0091633	11/05/1996	TX	30.0	30		F	10/25/1996	began feeling bad about 6hr p/flu vax;muscles aching h/a, stomachache, bottom of feet ached;sx lasted almost 24hr then felt better & feeling only weakness;									Y	10/24/1996	10/24/1996	0		PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	TX96176	1						1	Abdominal pain; Asthenia; Headache; Malaise; Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~6F71275~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091634	11/05/1996	MA	79.0	78		F	10/30/1996	3 days following vax pt exp arm discomfort lt arm from inj site to wrist, rated 4/10 (1-least- 10-most-severe) no redness, or swelling;took APAP w/o relief;discomfort cont on day 14 post vax;										10/15/1996	10/18/1996	3		PUB	PUB	Melatonin, Folic acid, Dalmane PRN, Synthroid, Vitamin B12;	NONE		~ ()~~~In patient	MA9617	1						1	Injection site pain; Pain	FLU3~CONNAUGHT LABORATORIES~6F71226~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~MASS. PUB HLTH BIOL LAB~TD59~UNK~~LA~TD ADSORBED (TDVAX)~1	USA		Influenza
0091635	11/05/1996	MA	72.0	72		M	10/31/1996	arm pain w/in 6hr p/vax;chills & fever w/in 12hr of inj;moderate swelling & erythema extending from triceps to midforearm;no adenopathy;lung sounds clear saw MD 31OCT96;										10/29/1996	10/29/1996	0		PUB	PUB	Corgard, Flonase	NONE	NKDA, allergic rhinitis, HTN, prostateca, hearing loss	~ ()~~~In patient	MA9616	1						1	Chills; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pain; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~6F71226~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0001D~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0091636	11/05/1996	MN	44.0	44		F	11/01/1996	reported diff breathing so severe pt could not sleep;pt stated hurt so bad;pt had a catch in lt chest area; couldn't take a deep breath;any deep breath causes that pain;couldn't hardly move either arm, they were sore;took Ibuprofen									N	10/30/1996	10/30/1996	0		PUB	PUB		NONE	NONE	NONE~ ()~~~In patient	MN97032	1						1	Chest pain; Dyspnoea; Hypokinesia; Hypoventilation; Injection site pain; Pain	FLU3~PFIZER\WYETH~4968163~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~6H81269~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0091637	11/05/1996	NY	70.0	69		F	10/17/1996	12OCT96 rxn to flu vax, swelling on eyes, face & rash, fever for 5 days temp was not measured;									Y	10/10/1996	10/12/1996	2	NONE	PUB	PUB	Vasotes, Cardicen	NONE	heart problems & HTN	NA~ ()~~~In patient	BA96028	1						1	Face oedema; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~6F71789~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091643	11/05/1996	CT	26.0	26		F	10/10/1996	p/vax pt c/o dizziness, BP taken BP 92/60 AR 80 reg, RR20;radial pulse 77 reg;911 called pt refused to got for f/u;									Y	10/10/1996	10/10/1996	0		OTH	UNK		dec BP pt stated hypotensive;	pt state none @ the time of vax;	~ ()~~~In patient		1						1	Dizziness; Hypotension	FLU3~CONNAUGHT LABORATORIES~6F71277~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091644	11/05/1996	NY	39.0	39		F	10/30/1996	woke up w/welts under rt breast & spread to back;no fever, some swelling & heat from welts;									U	10/29/1996	10/30/1996	1		PUB	UNK		thyroid	thyroid taking PTU	pt exp rxn in 1989 @ 30yr w/flu vax 1;~ ()~~~In patient	BA96031	1						1	Oedema; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71789~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091647	11/05/1996	OH	26.0	26		F	10/18/1996	w/in 60-90 min p/vax pt c/o flushing & chills;felt like had temp (temp was 98) site of inj was reddened & swollen;										10/15/1996	10/15/1996	0	NA	UNK	UNK	NA	NA	NA	~ ()~~~In patient		1						1	Chills; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4968181~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091649	11/05/1996	WI	3.0	2	1	F	10/30/1996	hives				Y					Y	10/09/1996	10/10/1996	1	NONE	PVT	PVT	NONE	NONE	asthma	~ ()~~~In patient		1						1	Urticaria	FLU3~PFIZER\WYETH~4968169~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091651	11/05/1996	GA	31.0	31		F	10/30/1996	SOB, chest discomfort, fever, chills, severe myalgias & arthralgia & coughing;onset w/in 3hr of vax;				Y					Y	10/29/1996	10/29/1996	0	NONE	PVT	UNK		NONE	NONE	pt exp fever, chills @ 29w/flu vax; dose 1 in 1994;~ ()~~~In patient		1						1	Arthralgia; Chest pain; Chills; Cough; Dyspnoea; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71355~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091652	11/05/1996	PA	81.0	80		F	10/30/1996	ecchymosis, induration of sit, shaking, chills, myalgias, & pain w/in 8hr of vax rt arm;				Y					Y	10/25/1996	10/25/1996	0		PVT	PVT	Micronase, Synthroid	tooth abscess recovering	NONE	~ ()~~~In patient		1						1	Chills; Ecchymosis; Injection site mass; Injection site pain; Myalgia; Tremor	FLU3~PFIZER\WYETH~4968204~7+~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~432682~2~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0091654	11/05/1996	TN	1.3	1	.3	M	10/30/1996	fever 105;febrile sz 30OCT96 OK p/sz;				Y					Y	10/28/1996	10/30/1996	2	NONE	PVT	PVT	NONE	NONE	Gastroesophageal reflux-resolving	NONE~ ()~~~In patient		1						1	Febrile convulsion; Infection; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71239~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~PFIZER\WYETH~6J71006~4~IM~LL~HIB (HIBTITER)~1|MMR~MERCK & CO. INC.~0392D~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0091659	11/05/1996	OH	48.0	48		F	10/18/1996	p/vax pt c/o dizziness, diaphoretic, pale, eyes bloodshot p/24hr, site reddened & swollen p/24hr;became SOB 12hr p/vax;										10/15/1996	10/15/1996	0	NONE	UNK	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Conjunctivitis; Dizziness; Dyspnoea; Hyperhidrosis; Injection site hypersensitivity; Injection site oedema; Pallor	FLU3~PFIZER\WYETH~4968181~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091660	11/05/1996	OH	61.0	60		F	10/21/1996	24hr p/vax pt arm was reddened & swollen (55 x 40mm);										10/14/1996	10/15/1996	1	NONE	UNK	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4968181~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091661	11/05/1996	OH	46.0	46		F	10/21/1996	24hr p/vax pt had local skin rxn (70x45mm) reddened, swelled, & itching;										10/15/1996	10/16/1996	1	NONE	UNK	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4968181~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091662	11/05/1996	OH	56.0	56		F	10/21/1996	24hr p/vax inj site reddened & swollen;										10/15/1996	10/16/1996	1	NONE	UNK	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4968181~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091663	11/05/1996	OH	80.0			M	10/18/1996	24hr p/vax site reddened, swollen, c/o SOB & c/o just don't feel well;										10/14/1996	10/14/1996	0	NONE	UNK	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Dyspnoea; Injection site hypersensitivity; Injection site oedema; Malaise	FLU3~PFIZER\WYETH~4968181~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091666	11/05/1996	KY				F	10/22/1996	erythematous tender bruise spreading from inj site;itching;									Y	10/21/1996	10/22/1996	1	NONE	PVT	PVT		NONE	perennial allergies-dust mites, ragweed	~ ()~~~In patient		1						1	Ecchymosis; Injection site hypersensitivity; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~4968155~3~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091667	11/05/1996	NY	76.0	76		F	11/01/1996	pt states exp arrhythmia @ home;it was not intense but lengthy (45-50 min);pt also stated arm was sore x 3 days;felt like a golf ball was in arm;tx pt prayed;										10/24/1996	10/24/1996	0		PUB	OTH		NONE	NONE	~ ()~~~In patient		1						1	Arrhythmia; Myalgia; Skin nodule	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0091668	11/05/1996	RI	31.0	31		F	10/31/1996	large area of localized redness & swelling around inj site;also noted itching;									U	10/30/1996	10/30/1996	0		PVT	OTH	NONE	NONE	tetracycline family, augment	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~CONNAUGHT LABORATORIES~6F71266~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091671	11/05/1996	PA	43.0	43		M	10/31/1996	obtained flu like s/s beginning 8 days p/vax;had temp fluctuations (hot & cold), mental slowness, weakness, fatigue, lack of energy, cough, some muscle aches, some joint pain;									Y	10/18/1996	10/27/1996	9	NONE	OTH	UNK	NOINE	NONE	NONE	pt exp rxn @41yr w/flu vax dose 1;~ ()~~~In patient		1						1	Arthralgia; Asthenia; Cough; Influenza; Myalgia; Pyrexia; Thinking abnormal	FLU3~CONNAUGHT LABORATORIES~6F71293~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091672	11/05/1996	MO	43.0	42		F	10/29/1996	pt recv vax 26OCT96 pain & redness @ site of inj that evening;Sunday pain was in neck, head & back;notified hlth dept on 28OCT96 & told to see PMD if problem persists;									U	10/26/1996	10/27/1996	1		OTH	UNK				~ ()~~~In patient		1						1	Back pain; Headache; Injection site hypersensitivity; Injection site pain; Neck pain	FLU3~PARKE-DAVIS~00176P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0091674	11/05/1996	RI	43.0	43		F	10/31/1996	localized redness &swelling around site of inj;									U	10/30/1996	10/31/1996	1		PVT	OTH	NONE	NONE	environmental, PCN	pt exp redness @ site @ 42yr w/PPD;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~6F71266~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091675	11/05/1996	WA	39.0	39		M		feverish, dizzy, tired, gen body aching, h/a;									Y	10/22/1996	10/23/1996	1		OTH	PUB	NONE	NONE	NONE	pt exp rxn in 1993 w/flu vax dose 1;~ ()~~~In patient		1						1	Asthenia; Dizziness; Headache; Myalgia; Pyrexia	FLU3~PARKE-DAVIS~00296P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0091676	11/05/1996	CA	52.0	52		F	10/29/1996	2 days p/vax pt had flu-like sx, chills, myalgia, local swelling, erythema, warm;pt states knows sx are from pneumovax site;									Y	10/11/1996	10/13/1996	2	NA	PVT	PVT	NA	NA	celiac sprue disease;	~ ()~~~In patient		1						1	Chills; Influenza; Injection site hypersensitivity; Injection site oedema; Myalgia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~00786P~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~M230NA~UNK~IM~~HIB (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~1626B~UNK~SC~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0091678	11/05/1996	MO	22.0	22		M	10/29/1996	approx 4-5min p/vax pt stated having problems breathing & chest is tight;BP 178/98, P108, R20;epi given;									Y	10/26/1996	10/26/1996	0	NA	OTH	PUB	unk	unk	allergic bee stings	unk~ ()~~~In patient		1						1	Chest pain; Dyspnoea; Hypertension; Tachycardia	FLU3~PFIZER\WYETH~4986203~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091679	11/05/1996	CO	24.0	24		F	10/29/1996	w/in 10min p/vax site became red, hot, approx 1in in diameter;no itching 1hr later c/o itching to forehead;ice & DPH;next day c/o severe migraine;full recovery;									Y	10/08/1996	10/08/1996	0		OTH	PVT		NONE	NA	~ ()~~~In patient		1						1	Injection site hypersensitivity; Migraine; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71236~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091682	11/05/1996	PA	25.0	25		F	10/30/1996	eye swelled shut;									Y	10/15/1996	10/16/1996	1		PUB	PVT	NONE	NONE		~ ()~~~In patient		1						1	Face oedema	FLU3~CONNAUGHT LABORATORIES~6F71286~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091683	11/05/1996	PA				M		sore throat, nasal congestion, sinus flare-up									U	10/23/1996	10/27/1996	4		PUB	UNK				~ ()~~~In patient		1						1	Pharyngitis; Rhinitis; Sinusitis	FLU3~CONNAUGHT LABORATORIES~6F71286~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091687	11/05/1996	WI	4.0	4		M	10/31/1996	large local rxn w/12cm of swelling & induration;									Y	10/26/1996	10/28/1996	2		PVT	PVT				~ ()~~~In patient		1						1	Injection site mass; Injection site oedema	FLU3~PFIZER\WYETH~4968168~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091710	11/06/1996	CA	36.0			F	11/01/1996	1wk p/vax pt exp paralysis in fingers & feet along w/slurred speech;pt was hosp & dx w/GBS;					Y	7			Y	10/09/1996	10/16/1996	7		PVT	PVT	NONE	unk	unk	~ ()~~~In patient		1						1	Guillain-Barre syndrome; Myasthenic syndrome; Paralysis; Peroneal nerve palsy; Speech disorder; Guillain-Barre syndrome; Paralysis; Speech disorder	FLU3~CONNAUGHT LABORATORIES~6F71289~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71289~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0091711	11/06/1996	FL	49.0	49		F	11/01/1996	8hr pos vax pt exp swelling in arm, soreness @ inj site, redness size of tennis ball--sore throat-closing of throat-temp over 100 congestion, fever, aches, pain all over;			Y						N	10/30/1996	10/30/1996	0	NONE	PUB	OTH	pt recv pneumovax in OCTOBER;			pt exp  stiffness lt side x 3wk w/flu vax;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Laryngospasm; Lung disorder; Myalgia; Oedema; Pharyngitis; Pyrexia; Cough; Dizziness; Laryngospasm; Oedema; Pharyngitis; Pyrexia; Rash maculo-papular; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~MEDEVA PHARMA, LTD.~E3106HB~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Life Threatening	Influenza
0091712	11/06/1996	WA	47.0	47		F	11/02/1996	5 days of illness post vax-hallucinations, fever, h/a, sore throat-garlic/onion taste in mouth, sore eyes, ears, mouth unusual burning in mouth, bruise for over 7 days @ inj site;			Y						N	10/23/1996	10/24/1996	1	NONE	OTH	PUB		NONE	hydro cortisone, ASA;	~ ()~~~In patient	WA961306	1						1	Dysgeusia; Ecchymosis; Hallucination; Malaise; Pain; Pharyngitis; Pyrexia; Stomatitis	FLU3~PARKE-DAVIS~00375P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening	Influenza
0091713	11/06/1996	MN	80.0	79		F	11/05/1996	started feeling sick-temp of 103;hallucinating, ached all over;called MD went to bed;			Y						N	11/02/1996	11/03/1996	1	NONE	OTH	OTH	THyroid pill	NONE	NONE	~ ()~~~In patient		1						1	Hallucination; Malaise; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0091714	11/06/1996	OH	44.0	44		F	11/02/1996	sore @ inj site;scratchy, sore throat, tired, runny nose, had to take a nap;extremely tired;losing voice;									N	10/30/1996	10/30/1996	0	NONE	PUB	PUB	Elfaroxi	NONE	hypothroidism	~ ()~~~In patient		1						1	Asthenia; Dysphonia; Injection site pain; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0091715	11/06/1996	WI	38.0	38		F	10/31/1996	6hr post vax pt began w/chills & shaking for approx 6hr;t101.8 extreme, nausea, dizziness, severe h/a;										10/29/1996	10/29/1996	0		OTH	OTH		NONE	MIGRAINE HEADACHES	~ ()~~~In patient		1						1	Chills; Dizziness; Headache; Nausea; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~00676P~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0091716	11/06/1996	NY	74.0	74		M	10/30/1996	pt showed signs of Bells palsy 2 days post vax subsequently has full blown Bells palsy;				Y					N	10/08/1996	10/10/1996	2	MRI-dx bells palsey	OTH	OTH	Calen SR, Maticle, plagvenil sulfate	NONE	hypertension, arthritis	~ ()~~~In patient		1						1	Facial palsy; Lacrimal disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0091717	11/06/1996	MI	72.0	72		F	11/01/1996	could not breath;could not speak out loud;dx w/bronchitis, laryngitis;eyes running w/thick fluid;hurt eyes-felt terrible, hurt all over;				Y					Y	10/23/1996	10/29/1996	6	CXR-negative pneumonia;rx ATB	OTH	OTH	Insulin, Provantil, Zestril	NONE	MS-diabetic	~ ()~~~In patient		1						1	Bronchitis; Conjunctivitis; Dyspnoea; Eye pain; Laryngitis; Malaise; Myalgia; Speech disorder	FLU3~PARKE-DAVIS~00376P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0091718	11/06/1996	MA	32.0	32		F	11/01/1996	n/v, fever, sore throat, chest & nasal congestion, fatigue, arm of inj extremely painful;									N	10/25/1996	10/26/1996	1	NONE	OTH	PUB	NONE	NONE	sulfa allergy	~ ()~~~In patient		1						1	Asthenia; Injection site pain; Lung disorder; Nausea; Pharyngitis; Pyrexia; Rhinitis; Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0091719	11/06/1996	TX	37.0	36		F	11/01/1996	@ inj site-red whelp started noc p/shot puffy, swollen 3 to 4 diameter-itchy-x 5 days;									Y	10/26/1996	10/27/1996	1	NONE	OTH	PVT	Dycyclomen, Elovil	thoraasix surgery	ASA allergy-thorasic? synd	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0091721	11/06/1996	NC	42.0	42		M	10/31/1996	pt recv vax & exp t100, mobility, problem arm, neck, shoulder & tingling & burning arm neck shoulder;weakness in both arms;joint problems;				Y					N	10/28/1996	10/29/1996	1	NONE	PUB	PUB	Axid, Creonzo	NONE	indigestion problems, pancreatitis, asthma	pt exp similar rxn in 1995 w/flu vax;~ ()~~~In patient	NC98021	1						1	Hypokinesia; Myasthenic syndrome; Neck pain; Osteoarthritis; Pain; Paraesthesia; Pyrexia; Guillain-Barre syndrome; Paraesthesia; Pyrexia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~PARKE-DAVIS~00296P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0091723	11/06/1996	WA	52.0	52		F	10/15/1996	14OCT woke up very stiff & sore;fever came on in PRN @ 2PM 101.7 lasted 12hr;today gen body soreness, fever gone, feels weak;states has had flu shot for post 6hr w/o any rxn;									Y	10/11/1996	10/14/1996	3		PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient	WA961286	1						1	Asthenia; Hypertonia; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4968162~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091724	11/06/1996	IL	41.0	41		M	10/28/1996	pt devel itchy rash, hives 24OCT-nausea;felt as if had the flu-swelling gradually improved-notified RN on 25OCT-said is not able to eat some-rash nearly gone-dry mouth;									Y	10/23/1996	10/23/1996	0	NA	OTH	OTH		NONE	denies	NONE~ ()~~~In patient		1						1	Anorexia; Dry mouth; Influenza; Nausea; Oedema; Pruritus; Rash; Urticaria	FLU3~PARKE-DAVIS~01066P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0091725	11/06/1996	IL	44.0	44		M	10/26/1996	rt forearm-rash (spreading up arm);also appear swollen;(recv shot in lt arm 23OCT96 first time noticed rash-wakened itching early 24OCT96 2AM;				Y						10/23/1996	10/24/1996	1		OTH	OTH	Zovirax	NONE	herpes	~ ()~~~In patient	IL960102	1						1	Oedema; Pruritus; Rash	FLU3~PARKE-DAVIS~01186P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0091738	11/06/1996	RI	35.0	35		F	10/31/1996	large area of localized redness & swelling around inj site;									U	10/30/1996	10/30/1996	0		PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~6F71266~3~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091739	11/06/1996	OR	59.0	59		F	11/01/1996	aches in muscles & joints;red hot feeling in knees;itchy, swelling, redness around POI;, runny nose, nasal congestion, weakness, fatigue, gastric upset;									Y	10/26/1996	10/27/1996	1	NA	PUB	PVT	Hyzaar, Tegretol, Mevacor, Premarin, Provera, thyroid, Klonopin, Calcium	NA	high blood pressure, high cholesterol, manic/depression	NONE~ ()~~~In patient		1						1	Arthralgia; Asthenia; Dyspepsia; Injection site hypersensitivity; Injection site oedema; Myalgia; Pruritus; Rhinitis	FLU3~CONNAUGHT LABORATORIES~6F71237~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091740	11/06/1996	NY				F	11/01/1996	itching of upper extremities followed by urticaria upper extremities & face;DPH given;									Y	10/31/1996	10/31/1996	0		OTH	OTH	NA	NONE	Indocin	~ ()~~~In patient		1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~6771222~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091741	11/06/1996	OR	67.0			M	10/10/1996	diarrhea, fever several hr p/inj 9OCT96, nausea & cont fever 10OCT96 when pt phoned to report sx;no inj site rxn noted;									U		10/09/1996			PVT	PVT						1						1	Diarrhoea; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~6F71276~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091742	11/06/1996	IL	67.0	67		F	10/31/1996	pain in lt arm since 15OCT96;warm soaks, NSAIDS;no fever, no neuro changes;				Y					N	10/15/1996	10/24/1996	9	CPK WNL; BUN/CR-WNL;	PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Pain	FLU3~CONNAUGHT LABORATORIES~6F71276~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091743	11/06/1996	NY	51.0	51		F	10/31/1996	acute BOM which began 3 days p/flu vax;no antecedent URI;									Y	10/18/1996	10/21/1996	3	NA	OTH	PVT	Synthroid, Atenolor	NONE	hyperthyroidism, s/p RAI oblatory AUG95	NONE~ ()~~~In patient		1						1	Otitis media	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0091744	11/06/1996	IL	31.0	31		F	10/30/1996	pt recv vax & reports soreness @ time of inj following day pt reported d x 6 days;pt also reports pins & needles type of numbness in lt extremity that began day p/vax;pt had diminished grip strength in lt hand;brachial plexus neuropathy;				Y					U	10/24/1996	10/25/1996	1		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Diarrhoea; Myasthenic syndrome; Neuropathy; Pain; Paraesthesia; Myasthenic syndrome; Neuropathy; Paraesthesia	FLU3~PARKE-DAVIS~00676P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00676P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0091745	11/06/1996	WA	48.0	48		M	10/31/1996	low grade temp, malaise, aching joints, sore throat, coughing;									N	10/24/1996	10/25/1996	1	NONE	OTH	PUB	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Arthralgia; Cough; Malaise; Pharyngitis; Pyrexia	FLU3~PARKE-DAVIS~00296P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0091747	11/07/1996	OH	50.0	49		F	10/24/1996	stuffed head, running nose, sneezing;									Y	10/21/1996	10/24/1996	3		PVT	OTH	NONE	NA	NA	~ ()~~~In patient		1						1	Headache; Rhinitis	FLU3~CONNAUGHT LABORATORIES~6F71277~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091748	11/07/1996	NY	54.0	54		F	11/01/1996	local swelling & pain @ inj site;									Y	10/30/1996	11/01/1996	2	local sx w/vax	PVT	PVT		pain, swelling	NONE	~ ()~~~In patient		1						1	Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4968185~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091752	11/07/1996	WI	29.0	29		F	10/29/1996	arm got red, hot, 2 x 6 reddened area same day;saw MD 3 days p/vax on Claritin for allerg rxn;				Y					Y	10/22/1996	10/22/1996	0		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Hypersensitivity; Injection site hypersensitivity; Vasodilatation	FLU3~PFIZER\WYETH~4968156~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091754	11/07/1996	DE	62.0	62		F	10/28/1996	13hr p/vax pt exp chills, body aches & malaise;then 4.5 days p/vax chills & body aches recurred, this time w/elevated temp 100.6;full recovery took 10 days during which time inj site remained tender to touch									Y	10/17/1996	10/17/1996	0	NA	PUB	PUB	NONE	NA	NA	~ ()~~~In patient	DE9607	1						1	Chills; Injection site pain; Malaise; Myalgia; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E3036GA~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0091756	11/07/1996	MD	49.0	49		M	11/07/1996	muscle pain of lt deltoid muscle;vesicular herpetic rash over distribution of the palmar/radial aspect of lt thumb lasting 3wk duration partially resolved on 7NOV96;				Y					N	10/07/1996	10/07/1996	0	NA	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Dermatitis bullous; Myalgia	FLU3~CONNAUGHT LABORATORIES~6F71255~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091757	11/07/1996	UT	55.0	55		F	10/23/1996	onset of heaviness of arm & tingling of fingers in the evening of 21OCT96;lt arm sx began 1-2hr later;the inj felt more painful than usual than other shots have felt;sx began by aching in upper arm, posterior shoulder;also tingling on thigh				Y					U	10/21/1996	10/21/1996	0		PUB	PUB	Micronase, Calcium, Vit C, Cit E for skin problem	NONE	diabetes	NONE~ ()~~~In patient	UT961024	1						1	Injection site pain; Myasthenic syndrome; Paraesthesia	FLU3~PFIZER\WYETH~4968203~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091873	11/07/1996	FL	62.0	62		F	09/09/1996	pt recv vax OCT94 & next day devel severe pain in groin, legs, arms, hips, feet, toes, & soles of feet;pain was not resolved despite trails of multiple meds;pt recv flu vax 95-96 w/o a change in sx;				Y					N	10/01/1994	10/01/1994	0		PUB	OTH	Premarin, Prinivil, Diabeta	NONE		~ ()~~~In patient	896255023L	1						1	Arthralgia; Pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0090760	11/08/1996	IA	52.0	52		M	10/21/1996	pt recv vax 1OCT96 & 2OCT96 devel a fever of 100;3OCT cont to have a fever & devel a cough;4OCT the cough became productive for green sputum;5OCT pt became SOB, went to ER, dx w/pneumonia by x-ray & was adm to hosp x 5 days;				Y	Y	5			Y	10/01/1996	10/03/1996	2	5OCT x-ray: indicative of pneumonia	PUB	OTH	unk	NONE		~ ()~~~In patient	896298026L	1						2	Cough; Dyspnoea; Pneumonia; Pyrexia; Chills; Cough; Dyspnoea; Infection; Laboratory test abnormal; Lung disorder; Pneumonia; Pyrexia	FLU3~PFIZER\WYETH~4968181~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968181~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0091788	11/08/1996	PA	64.0			M	10/10/1996	1wk following vax pt exp abd discomfort w/o diarrhea;devel limb weakness & fasiculations;became parapatetic & then wheelchair bound;pt hosp;tone sl dec;vibratory sensations mildly dec @ great toes;				Y	Y				Y				CBC, blood chem, cervical & lumbar spine MRE-nl;EMG 2wk p/onset: peroneal & tibial motor amplitudes mildly dec, F wave latencies prolonged;sensory responses nl, fibrillation & fasiculation potentials seen in muscles in all extremities,	OTH	OTH	unk	unk		~ ()~~~In patient	896292002L	1						1	CSF test abnormal; Hypokinesia; Hyporeflexia; Hypotonia; Laboratory test abnormal; Myasthenic syndrome; Paraesthesia; Paralysis	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0091789	11/08/1996	NE	44.0	43		F	10/21/1996	pt devel muscle soreness 1 to 2 days p/vax;then devel muscle pain, numbness in extremities & lips, diff swallowing;pt hosp 17OCT96 & on 18OCT96 neurologist dx GBS;pt being treated w/albumin plasma exchange;				Y	Y				N	10/03/1996	10/12/1996	9	lumbar puncture-CSF w/inc protein;EMG both legs, polyradiculoneuropathy;CBC;	PVT	OTH	multivitamin, nutritional supplements inc Echinacaea	NONE	hiatal hernia, seasonal allergies, modified radical left mastectomy in 1994 for extensive ductal carcinoma in situ, silicone breast implant	~ ()~~~In patient	896297016L	1						1	Asthenia; Dysphagia; Guillain-Barre syndrome; Hyporeflexia; Infection; Myalgia; Paraesthesia; Sinusitis	FLU3~PFIZER\WYETH~4968168~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0091791	11/08/1996	UT	79.0	79		F	10/22/1996	pt recv vax 15OCT96 & 6PM on 17OCT96 pt fainted;upon arousal pt c.o stomach pain, diarrhea, & nausea;pt dies in home 8:45Pm;	Y	10/17/1996							N	10/15/1996	10/17/1996	2		PVT	OTH	Cardizem, Cyodur,asthma shot, pred	unk	asthma, heart problems, arthritis, aortic aneurysm	~ ()~~~In patient	896297025L	1						1	Abdominal pain; Diarrhoea; Nausea; Syncope	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0091794	11/08/1996	TX	65.0	64		U	10/25/1996	approx 6hr p/vax pt began having fever & chills;spent the next 5 days in bed w/extreme diarrhea & all the typical flu aches (bones, eyes, etc) greatly magnified;pt lost 5 lb;pt stated never been so sick & is nl healthy;pt did not call			Y						U	10/17/1996	10/17/1996	0		OTH	PVT	Lopressor, Dyazide, Premarin, Provera	NONE	I take BP med (HTN);allergies-trees, weeds;	~ ()~~~In patient		1						1	Arrhythmia; Arthralgia; Hypertension; Hypotension; Influenza; Malaise; Myalgia; Weight decreased	FLU3~CONNAUGHT LABORATORIES~6F71223~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0091796	11/08/1996	IL	51.0	50		F	10/30/1996	approx 15min p/vax c/o entire arm & shoulder hurting, erythema @ site;approx quarter size;approx 30min p/vax c/o nausea & inc aching into back;sent to MD where exp inc dyspnea & diff w/swallowing;given adrenaline & antihistamine @ MD				Y	Y	1			Y	10/28/1996	10/28/1996	0	NONE	PUB	PUB	unk	NONE	NONE-had ?? allergic rxn to either bee or spider bite	NONE~ ()~~~In patient	IL960105	1						1	Dysphagia; Dyspnoea; Injection site hypersensitivity; Myalgia; Nausea; Pain	FLU3~CONNAUGHT LABORATORIES~6F71307~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0091798	11/08/1996	VA	37.0	36		M	11/06/1996	pt recv vax 4NOV96 early AM;6NOV96 AM pt felt nauseated, run down, fatigue;no fever;pt daughter exp similar sx day a/vax;									Y	11/04/1996	11/06/1996	2		PUB	PUB		NONE	NONE	~ ()~~~In patient	VA96079	1						1	Asthenia; Nausea	FLU3~PFIZER\WYETH~4968173~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091799	11/08/1996	CA	69.0	69		M	10/31/1996	pt states that p/vax noted painless swelling of lt elbow;says swelling was not present prev;inj was given lt deltoid;swelling was noted to be olecranca bursa, non tender relationship to vax unk;									Y	10/31/1996	10/31/1996	0	NONE	PUB	PUB	Accupril, Amilodipine	HTN, diabetes	PCN allergy, HTN, diabetes	~ ()~~~In patient	CA960112	1						1	Oedema	FLU3~PFIZER\WYETH~6F71212~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091800	11/08/1996	IA	57.0	57		M	11/05/1996	2 days p/vax pt noted throat scratchy;2 days later fever 101 to 103 lasting for 5 days;also noted coughing & aching;stayed in for 7 days;									Y	10/24/1996	10/26/1996	2	NA	PUB	PUB	NA	NONE	NONE	NA~ ()~~~In patient	IA96037	1						1	Cough; Myalgia; Pharyngitis; Pyrexia	FLU3~PARKE-DAVIS~00686P~1~SC~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0091801	11/08/1996	MD	40.0	40		F	11/06/1996	hot flashes;flush face;welt devel around sit of inj;also reddened area 4 diameter;itchy & warm to touch 1hr past inj;pt took med;									Y	10/15/1996	10/15/1996	0	NONE	PUB	PUB	NONE	NONE		NONE~ ()~~~In patient	MD96048	1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E30266B~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0091802	11/08/1996	MA	55.0	55		F	11/04/1996	mod sized blisters cover mouth, inside under nose top lip 2 days p/flu vax very itchy-none on hands;				Y						10/30/1996	11/01/1996	2		PUB	PUB	Thyroid, Depakote, hypertension	NONE	manic depression	NONE~ ()~~~In patient	MA9618	1						1	Dermatitis bullous; Pruritus	FLU3~CONNAUGHT LABORATORIES~6F71226~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091809	11/08/1996	ID	75.0	75		F	10/16/1996	rt upper arm local rxn swollen & hot to touch above elbow edematous ridge noted did not extend into axilla;no swollen lymph nodes noted;pt states swelling is going down;16OCT96 pt seen no further problem swelling down, area turned sl									Y	10/09/1996	10/09/1996	0		PUB	PVT		NONE		NONE~ ()~~~In patient	ID96077	1						1	Injection site oedema; Skin discolouration; Vasodilatation	FLU3~PFIZER\WYETH~4968203~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1076B~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0091812	11/08/1996	VA	61.0	61		F	11/06/1996	redness & swelling began over upper lt arm PM of 4NOV96;redness & swelling cont to enlarge over area until it was 8 x 5 in size warm to touch;DPH given w/o dec in signs;6NOV96 swelling began to resolve;									Y	11/04/1996	11/04/1996	0	NOEN	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4968173~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~432684~1~SC~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0091815	11/08/1996	OK	71.0	71		F	10/23/1996	pt recv vax @ 12noon began itching 5PM-took DPH stopped next day itch resumed still taking is doesn't take begans itching better today;took flu shot yr ago & had itching then;									Y	10/16/1996	10/16/1996	0		PUB	PUB	Niancin, Ibuporphne Am	NONE	PCN, Mascara	Pt exp itching 20yrs ago fw/flu vax; dose 1;~ ()~~~In patient	OK9639	1						1	Pruritus	FLU3~CONNAUGHT LABORATORIES~5F61120~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~429999~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0091816	11/08/1996	OK	73.0	73		F	10/25/1996	22OCT96 devel severe itching & gen rash & wheals;cont for 3 days by itching dec & rash less pronounced today;									Y	10/21/1996	10/22/1996	1	NONE	PUB	PUB		NONE	CHD, hx of qud bypass surgery	NONE~ ()~~~In patient	OK8638	1						1	Pruritus; Rash; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E3066GB~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1626B~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0091817	11/08/1996	OK	68.0	68		M	10/18/1996	10min p/vax had hot feeling across chest, nausea, SOB, numbness & weakness, numbness in hands & feet;1hr p/vax went to ER recv Atarax & pred;returned home p/3hr in ER;MD stated was a rxn to vaccine;				Y					Y	10/16/1996	10/16/1996	0		PUB	PUB	NONE	NONE	NONE	pt exp rxn 25OCT95 w/ flu vax dose 4;~ ()~~~In patient	OK9637	1						1	Asthenia; Dyspnoea; Nausea; Paraesthesia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3066CB~6~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0091819	11/08/1996	NC	51.0	51		M	10/24/1996	22OCT96 pt awoke w/lt arm/shoulder pain;12:30 PM aching lt arm & head;felt lightheaded & about to pass-APAP relieved h/a & muscle ache;took Ibuprofen 22OCT96-23OCT96 not feel well that AM by afternoon achy in lt should & head & upper spine				Y					U	10/17/1996	10/22/1996	5		OTH	PUB	Beconase inhalent	NONE	hayfever	NONE~ ()~~~In patient	NC96117	1						1	Arthralgia; Dizziness; Headache; Myalgia; Pain	FLU3~PARKE-DAVIS~986P~3~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0091820	11/08/1996	MS	64.0	64		F	10/24/1996	local edema, redness client was shaky;DPH given;									Y	10/24/1996	10/24/1996	0		PUB	OTH		NONE		~ ()~~~In patient	MS96043	1						1	Injection site hypersensitivity; Injection site oedema; Tremor	FLU3~MEDEVA PHARMA, LTD.~E30899B~7+~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1284B~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0091821	11/08/1996	MS	61.0	60		M	10/22/1996	pt recv vax 20OCT96 in rt arm & c/o pain w/swelling from upper arm to fingers;pain lasted 1 1/2 days;swelling has started to subside p/2 days;				Y					Y	10/20/1996	10/20/1996	0	NONE	OTH	OTH	Coumadin	past heart problems	wasps	NA~ ()~~~In patient	MS96044	1						1	Oedema; Pain	FLU3~MEDEVA PHARMA, LTD.~E3086B~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1284B~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0091824	11/08/1996	MA	46.0	46		F	11/04/1996	felt nauseated immed p/inj;felt weak @ 5 p/inj then said felt heart pounding-perspiring profusely;amb called-felt better by time arrived @ 12:45PM;									Y	10/29/1996	10/29/1996	0	NONE	OTH	OTH	verapemil, amiloride w/HCTz;	NONE	HTN	~ ()~~~In patient		1						1	Asthenia; Hyperhidrosis; Nausea; Palpitations	FLU3~CONNAUGHT LABORATORIES~6F71226~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091825	11/08/1996	RI	30.0	30		F	11/01/1996	large band area of swelling, redness;area itchy;									U	10/30/1996	10/30/1996	0	NA	OTH	OTH	Klonopin	NONE	asthma, environmental allergies	pt exp redness @ 28yr w/PPD~ ()~~~In patient		1						1	Oedema; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71266~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091827	11/08/1996	NJ	43.0	43		F	11/04/1996	1 1/2hr p/vax pt woke up dizzy & felt was going to  pass out;pt husband said pt look like a ghost;pt had lump in throat;pt kept repeating I am going to die;husband called 911;pt felt jittery & hyper & couldn't get back to sleep;poss low BP;									Y	10/21/1996	10/21/1996	0	NONE	PVT	OTH	NONE	NONE	TB skin test vaccine-local rxn;	NONE~ ()~~~In patient		1						1	Agitation; Dizziness; Dysphagia; Hypotension; Insomnia; Pallor	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0091831	11/08/1996	MA	48.0	48		F	11/04/1996	circumoral numbness spread through face;dizziness lightheadedness;diaphoretic;tingling in fingertips;				Y					Y	10/28/1996	10/28/1996	0	EKG nl	OTH	OTH	Accupril x 1yr	NONE	stinging insects;carries epipen;compazine, PCN	NONE~ ()~~~In patient		1						1	Dizziness; Hyperhidrosis; Paraesthesia; Paraesthesia oral	FLU3~PFIZER\WYETH~4968190~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091462	11/10/1996	CA	39.0	39		F	10/21/1996	pt recv vax & 11 days later pt awoke  c/o gen malaise, h/a, t102;PMD gave pt ATB;next day had a gen fine maculopapular rash;seen by MD;dx measles;				Y					Y	09/20/1996	10/01/1996	11	NONE	PVT	PVT	ATB, Ibuprofen, possibly;PPD (Mantoux) test by Connaught lot# 242411 given 20SEP96	NONE	NONE	NONE~ ()~~~In patient		1						1	Headache; Infection; Malaise; Pyrexia; Rash maculo-papular	FLU3~PFIZER\WYETH~4968161~3~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091721	11/11/1996	NC	42.0	42		M	11/01/1996	1 day following vax pt exp a fever of 99.8, redness & tingling sensation in rt arm, neck, spine & lt arm occurred several days later;pt seen by pvt provider;6NOV96 fever of 100 & pains;									U	10/28/1996	10/29/1996	1		PUB	PVT	Axid, Creon-20	NONE	indigestion secondary pancreatic disorder	pt exp rxn in 1995 w/flu vs Td vax;~ ()~~~In patient		1						2	Hypokinesia; Myasthenic syndrome; Neck pain; Osteoarthritis; Pain; Paraesthesia; Pyrexia; Guillain-Barre syndrome; Paraesthesia; Pyrexia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~PARKE-DAVIS~00296P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0091852	11/11/1996	VA	48.0	48		F	11/06/1996	pt recv vax 4NOV96 & swelling & redness started 5NOV96-local rxn only;pain, swelling & redness much worse;				Y					N	11/04/1996	11/05/1996	1	NONE	PVT	PVT	HHR, potassium, Synthroid	NONE	hypertension, hypothyroidis	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~00686P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~LEDERLE LABORATORIES~433580~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0091853	11/11/1996	LA	58.0	58		U	10/29/1996	red, itchy, sore area lt deltoid being noticed 2 to 3 days p/vax;MD dx cellulitis vs local allergic rxn;rx ATB & pt reports resolution when contacted on 29OCT96;				Y					Y	10/07/1996	10/10/1996	3	no dx tests reported by MD office;	PUB	PUB	Coumadin		deep vein thrombosis	~ ()~~~In patient	LA961101	1						1	Cellulitis; Hypersensitivity; Injection site hypersensitivity; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~4968165~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~6A81017~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0091858	11/11/1996	RI	61.0	61		F	11/05/1996	lightheaded, weakness, large area of redness, SOB;									Y	10/31/1996	11/01/1996	1		PVT	OTH	Synthroid, Prempio.Ventalin, Flonase	NONE	asthma, PCN, ceclor, environmental	NA~ ()~~~In patient		1						1	Asthenia; Dizziness; Dyspnoea; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71266~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091859	11/11/1996	CA	1.9	1	.9	F	11/05/1996	1-1 1/2 hr p/vax devel cough, wheeze, mucous production, resp distress;ER visit, aerosol rx;				Y					Y	11/04/1996	11/04/1996	0	NA	PVT	PVT	NONE	NONE	down's synd s/p repair ASD, PDA	NONE~ ()~~~In patient		1						1	Asthma; Cough; Mucous membrane disorder; Respiratory disorder	FLU3~CONNAUGHT LABORATORIES~6F71320~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0782D~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0091860	11/11/1996	MA	41.0	41		F	10/23/1996	20OCT96 red area size of a quarter @ site;21OCT96 soreness @ site;22OCT96 redness @ site to elbow;pain & swelling to elbow;									Y	10/19/1996	10/20/1996	1	NONE	PUB	PUB	Zanax, Trayadone	NONE	?allergic to sulfa	~ ()~~~In patient	MA9611	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema	FLU3~CONNAUGHT LABORATORIES~6F71226~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0001D~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0091866	11/11/1996	MI	25.0	25		F	11/05/1996	20OCT96 evening lt arm sore, red ache;23OCT96 swollen neck & glands;24OCT96 3AM breathing diff SOB didn't feel good;25OCT96 saw MD started Ibuprofen for pain, swelling ap/3 days still swollen glands;28OCT96 started ATB;4NOV96 still SO				Y						10/21/1996	10/23/1996	2	NONE	OTH	PVT	Thyroid, Birth control	NONE	dogs, cats, mold, pollen	NONE~ ()~~~In patient		1						1	Dyspnoea; Lymphadenopathy; Malaise; Myalgia; Oedema; Pain; Vasodilatation	FLU3~PARKE-DAVIS~01186P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0091869	11/11/1996	OH	80.0	80		F	10/25/1996	had just sore arm x1hr;6hr later had very sore muscles in neck, arm, back & shoulder;went to MD 25OCT96 said rxn to flu vax & gave Pred;feels no better yet even eyes hurt on 4th day post vax;was told by MD to reconsider flu shot next				Y					Y	10/21/1996	10/21/1996	0	NONE	PUB	PUB	Prinivil	NONE	NONE x/HTN	NONE~ ()~~~In patient	OH96140	1						1	Eye pain; Myalgia	FLU3~CONNAUGHT LABORATORIES~6F71308~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091441	11/12/1996	PA	47.0	47		M	10/28/1996	pt recv vax 28OCT96 & 11AM to ER w/diaphoresis, dizziness, lightheadedness, soreness in jaw, sl heaviness in chest, SOB;tx w/02, IV therapy;EKG was nl;pt exp sz & 911 contacted;pt arrived @ hosp in asystole & pronounced dead @ hosp;	Y	10/28/1996		Y					N	10/28/1996	10/28/1996	0	EKG-nl	MIL	MIL	NONE	NONE	NONE	~ ()~~~In patient	896303034L	1						2	Chest pain; Dizziness; Dyspnoea; Hyperhidrosis; Hypoxia; Myalgia; Cardiac arrest; Chest pain; Convulsion; Dizziness; Dyspnoea; Hyperhidrosis; Pain	FLU3~PFIZER\WYETH~4968202~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968202~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Results in Death	Influenza
0091744	11/12/1996	IL	31.0	31		F	10/31/1996	pt recv vax & devel lt extremity numbness on 25OCT96, 1 day p/vax;because of cont sx pt went to MD on 30OCT96 for further sl diminished grip strength;pt dx w/brachial plexus neuropathy;				Y					N	10/24/1996	10/25/1996	1	NONE	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	0010150960045	1						2	Diarrhoea; Myasthenic syndrome; Neuropathy; Pain; Paraesthesia; Myasthenic syndrome; Neuropathy; Paraesthesia	FLU3~PARKE-DAVIS~00676P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00676P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0091879	11/12/1996	MA	34.0	34		F	11/07/1996	devel pneumonia of rt lower lung 4 to 6 days post vax;severe neck & head pain-inability to breath;dx pneumonia-post CXR x 2;			Y	Y					N	10/23/1996	10/29/1996	6	blood work/UA;CXR-pneumonia;	PUB	OTH	APAP #3, Biaxin, Albuterol inhaler, arithromycin	NONE	NONE	~ ()~~~In patient		1						1	Dyspnoea; Headache; Infection; Neck pain; Pneumonia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0091880	11/12/1996	KS	34.0	33		F	11/07/1996	noc post vax awakened w/t103;severe chills, achiness all over body, very weak-felt this was serious side effect-caused pt to have sz d/t high temp;				Y						11/05/1996	11/06/1996	1		OTH	OTH				~ ()~~~In patient		1						1	Asthenia; Chills; Convulsion; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0091882	11/12/1996	NC	61.0	61		F	11/10/1996	4th day post vax-exp flu like sx-temp dropped to 96.4, aches, pains, sore throat, congestion, upset stomach;									N	11/04/1996	11/08/1996	4	NONE	PUB	PUB	Premarin, Synthroid, Zucor	NONE	NONE	pt exp mild sx of flu @ 60 w/flu vax;~ ()~~~In patient	NC96131	1						1	Dyspepsia; Hypothermia; Influenza; Myalgia; Pain; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0091883	11/12/1996	LA	32.0	32		M	11/07/1996	pt exp nausea, fever, irritable, swelling in arm-lt arm;muscles are tight, numb muscle spasms, thirsty, tired, sleepy, dizzy, drowsy;									N	11/05/1996	11/06/1996	1	NONE	PUB	PUB	NONE APAP post vax	NONE	NONE	~ ()~~~In patient	LA961102	1						1	Asthenia; Dizziness; Hypertonia; Nausea; Oedema peripheral; Paraesthesia; Pyrexia; Somnolence	FLU3~MEDEVA PHARMA, LTD.~E2986FA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0091886	11/12/1996	MA	29.0	29		F	10/28/1996	24OCT96 1hr p/vax sharp pain was exp across chest which lasted 1/2hr @ that time;breathing was also diff;24 hr later site of inj was red 7 sore, completely resolved w/in 48hr;									Y	10/24/1996	10/24/1996	0	NONE	PVT	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Chest pain; Dyspnoea; Injection site hypersensitivity; Injection site pain	FLU3~CONNAUGHT LABORATORIES~6F71226~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091887	11/12/1996	MA	38.0	38		F	11/01/1996	nausea, h/a, sore itchy arm since recv vax APAP & ice to arm w/full recovery aside from arm soreness on 27OCT96;									Y	10/24/1996	10/24/1996	0	NONE	PVT	PUB	NONE	NONE	PCn allergy	father exp nausea, h/a @ 78yr w/flu vax dose 1~ ()~~~In patient		1						1	Headache; Myalgia; Nausea; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71226~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091888	11/12/1996	NY	55.0			F	10/31/1996	localized rxn, redness, itching, DPH;									Y	10/31/1996	10/31/1996	0	NONE	PUB	OTH				~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~433400~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0091890	11/12/1996	WI	38.0	38		F	10/29/1996	devel hives on abd less than 24hr p/vax;has taken DPH;									Y	10/28/1996	10/29/1996	1	NONE	PUB	PVT	NONE	NONE	tetanus toxoid	pt exp rxn @ 18 w/tetanus toxoid~ ()~~~In patient		1						1	Urticaria	FLU3~PFIZER\WYETH~4968169~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091891	11/12/1996	UT	47.0	47		F	11/04/1996	pt stated started feeling weird the noc of 24OCT96;face swelled & got hives a day later;				Y					U	10/24/1996	10/25/1996	1	NONE	PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Face oedema; Personality disorder; Urticaria	FLU3~PFIZER\WYETH~4958150~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091892	11/12/1996	OH	26.0	26		F	10/16/1996	pt recv flu vax 5min p/vax in lt deltoid;c/o nausea & faintness;nurse w/pt @ side fainted;loss of consciousness & stiffness 3sec & recovery;states has a hx of anxiety attacks;911 called & pt taken to hosp;				Y					U	10/16/1996	10/16/1996	0		OTH	OTH		denied	no hx medical problem-hx of anxiety attacks;	~ ()~~~In patient		1						1	Hypertonia; Nausea; Stupor; Syncope	FLU3~PFIZER\WYETH~6F71275~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091895	11/12/1996	NY	34.0	34		F	10/22/1996	15OCT96 10PM very warm-achy w/chills-1wk t101;16OCT95 530AM in bathroom, passed out, spouse found pt unconscious-eye opened;appeared gasping for air;pt recovered but felt hot & nauseous all day;									Y	10/15/1996	10/15/1996	0	saw MD 18OCT lab test ordered;	OTH	OTH	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Chills; Coma; Dyspnoea; Nausea; Pyrexia; Syncope	FLU3~CONNAUGHT LABORATORIES~6F71296~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091896	11/12/1996	MI	44.0	44		F	10/25/1996	pt exp poss allerg rxn, flu shot hurt @ time of inj, burning sensation in arm when given;11/2hr later feeling dizzy & nauseated;BP lt 120/68;diff breathing, t99.6;wheezing, SOB, 02 started;dx as rxn to flu vax;				Y					Y	10/24/1996	10/24/1996	0	EKG 24OCT nl	PUB	PUB	No other meds	NONE	NONE	~ ()~~~In patient	MI96160	1						1	Asthma; Dizziness; Dyspnoea; Hypersensitivity; Hypotension; Hypoxia; Injection site pain; Nausea	FLU3~PFIZER\WYETH~4968163~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091899	11/12/1996	MI	47.0	47		F	10/15/1996	started itching 8OCT96 & hives on 9OCT96-11OCT96;cont to have itching denies fever, edema, & SOB;									Y	10/07/1996	10/08/1996	1		PUB	PUB	TOpral, Premarin	NONE	rapid heart beat-Toprol	NONE~ ()~~~In patient	MI96155	1						1	Pruritus; Urticaria	FLU3~PFIZER\WYETH~4968172~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091900	11/12/1996	MI	70.0	70		M	10/28/1996	pt recv vax 25OCT96 PM by that evening the rt arm was painful & tender by sat noon the rt arm was hot, tender & swollen from the shoulder to below the elbow;pt went to ER on 26OCT96 PM;given IV & then had steroid through the IV & sent				Y					Y	10/25/1996	10/25/1996	0		PUB	OTH	Trental TID;	NONE	triple bypass surgery JUL96;rt arm was used to inject dye for testing prior to surgery	~ ()~~~In patient	MI96153	1						1	Myalgia; Oedema peripheral; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4968204~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~453959~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0091903	11/12/1996	WI	42.0	42		F	11/06/1996	devel pruritis of scalp, hands, eyelids;no hives observed;DPH given;									Y	10/23/1996	10/23/1996	0	NONE	PUB	PVT	NONE	NONE	septra, Ampicillin	~ ()~~~In patient		1						1	Pruritus	FLU3~PFIZER\WYETH~4968169~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091910	11/12/1996	IL	62.0	62		F	11/08/1996	coughing-t102, aches, chills, runny nose, h/a;pains in chest-stuffed up-rib pain from coughing;									N	11/01/1996	11/04/1996	3	NONE	OTH	OTH				~ ()~~~In patient		1						1	Chest pain; Chills; Cough; Headache; Myalgia; Pain; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0091911	11/12/1996	IL	69.0	69		M	11/08/1996	coughing, aches, chills, pains in chest									N	11/01/1996	11/06/1996	5	NONE	OTH	OTH				~ ()~~~In patient		1						1	Chest pain; Chills; Cough; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0092193	11/12/1996	MA	23.0	23		F	10/30/1996	fatigue, h/a, body aches, t100.9 po, swelling & hives on lt arm;31OCT96 7PM completely resolved by Sunday afternoon, APAP for relief;									Y	10/24/1996	10/24/1996	0	NONE	PVT	PUB	BCP Desogen	UTI Monday 28OCT96	NONE	pt father exp allerg rxn w/flu vax dose 1;~ ()~~~In patient		1						1	Asthenia; Headache; Myalgia; Oedema; Pyrexia; Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71226~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091913	11/13/1996	MN	53.0	52		F	11/07/1996	hives, problems breathing;					Y	1			Y	11/05/1996	11/05/1996	0		PVT	PVT	mite/mold/pollen inj;	NONE	allergies mite,mold, pollen;	~ ()~~~In patient		1						1	Dyspnoea; Hypotension; Urticaria	FLU3~CONNAUGHT LABORATORIES~6571239~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0091915	11/13/1996	WI	68.0	68		M	11/04/1996	general malaise, persistent weakness, some n/v & some orthostatic light-headedness;strongly hemoccult positive stools;hemoglobin 9.7;blood sugar 227;pt is diabetic;ultrasound revealed live-abscess;rt & lt shoulder pain;sx w/liver absc				Y	Y	13			Y	10/05/1996	10/19/1996	14	CAT scan ultrasound, CBC, chem profile, C&X strain of pus fluid aspirated, hemocculting stools etc;	PVT	OTH	Demerol for pain		diabetic, diverticulitis, allergies NKA	NONE~ ()~~~In patient		1						1	Abscess; Asthenia; Condition aggravated; Dizziness; Gastrointestinal haemorrhage; Hepatocellular damage; Laboratory test abnormal; Orthostatic hypotension	FLUX~UNKNOWN MANUFACTURER~~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0091916	11/13/1996	MO	57.0	56		F	11/06/1996	neurological sx-3wk p/vax lasted 3-4months-later dx w/multiple sclerosis @ age 57-no prior hx;no subsequent similar event in last 3yr;								Y	Y	10/01/1993	11/01/1993	31	MRI & LP	PVT	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Extensor plantar response; Multiple sclerosis; Neuropathy	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0091941	11/13/1996	NC	75.0	75		F	11/05/1996	cellulitis lt arm-EES 333 ordered x 7 days;				Y						11/03/1996	11/03/1996	0		PUB	PUB	Coumadin, Lotensin	NA	PCN	NONE~ ()~~~In patient	NC96130	1						1	Cellulitis	FLU3~PARKE-DAVIS~00296P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~436768~1~IM~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0091943	11/13/1996	IN	31.0	31		F		day p/vax pt neck became stiff & sore;									Y	10/08/1996	10/09/1996	1	NONE	PUB	PUB		NONE	NONE	~ ()~~~In patient		1						1	Neck pain; Nuchal rigidity	FLU3~CONNAUGHT LABORATORIES~6F71223~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091944	11/13/1996	NC	58.0	58		F	11/01/1996	pt recv vax 4OCT96 & on 11OCT96 pt noted redness, swollen, & warm to touch on lt deltoid area;pt w/ATB ?name				Y					Y	10/04/1996	10/11/1996	7		OTH	PUB		NONE	allergic to PCN	~ ()~~~In patient	NC96129	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PARKE-DAVIS~00986P~1~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~CONNAUGHT LABORATORIES~6F81189~1~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0091945	11/13/1996	NC	24.0	24		F	11/07/1996	fever, chills, severe aching-pain, mild nausea;t101.8 resolving @ 244hr;				Y					Y	10/30/1996	10/30/1996	0	NA	OTH	PVT				NA~ ()~~~In patient		1						1	Myalgia; Nausea; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71195~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091948	11/13/1996	GA	64.0	64		U	11/04/1996	approx 18hr p/vax pt arm began to get red & swell;by next day severe redness, induration, & swelling w/soreness;dark spot 10 days p/vax;									Y	10/25/1996	10/26/1996	1		PVT	OTH		NONE	NONE	pt exp rxn w/tetansu toxoid;~ ()~~~In patient		1						1	Myalgia; Oedema; Pain; Skin discolouration; Skin nodule; Vasodilatation	FLU3~PFIZER\WYETH~4968155~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091951	11/13/1996	OH	56.0	56		M	11/04/1996	pt c/o chest pain, became diaphoretic, BP dec to 90/50;epi given;squad arrived w/in 10min of onset BP inc to 108/70;pt refused to be transported to hosp;									Y	10/09/1996	10/09/1996	0	NA	PUB	PVT	NONE	NONE	NA	~ ()~~~In patient		1						1	Chest pain; Hyperhidrosis; Hypotension	FLU3~CONNAUGHT LABORATORIES~6F71237~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091954	11/13/1996	NJ	68.0	68		M	10/15/1996	nausea, sweating, feeling faint;given epi;									Y	10/15/1996	10/15/1996	0		OTH	OTH	NONE	NA	NA	NONE~ ()~~~In patient		1						1	Dizziness; Hyperhidrosis; Nausea	FLU3~CONNAUGHT LABORATORIES~6F71277~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091955	11/13/1996	NJ	39.0	39		F	10/25/1996	approx 7min p/vax pt appeared ashen, BP 80/50, pulse 72, sl diff breathing but lungs clear, resp 24;911 called c/o feeling like was going to die;epig given;pt feeling itchy & weakness;inc tightness in chest, diaphoresis, dec breath so				Y						10/25/1996	10/25/1996	0	P92, R26 BP 120/50;	OTH	OTH		NONE		~ ()~~~In patient		1						1	Asthenia; Chest pain; Cyanosis; Dyspnoea; Hyperhidrosis; Hypotension; Lung disorder; Pruritus	FLU3~CONNAUGHT LABORATORIES~6F71277~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091958	11/13/1996	RI	34.0	34		F	11/05/1996	severe itchy rash covering upper torso, neck & scalp;rx Hydrocortisone & Mycolog creas by pvt MD;				Y					N	10/30/1996	11/01/1996	2		PVT	OTH	NONE	NONE	hayfever, eczema (as a child)	NA~ ()~~~In patient		1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~6F71266~3~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091960	11/13/1996	IL	76.0	76		M	11/08/1996	pt recv vax 16OCT96 & exp various mild aches & pains;pains located in back, sides, arms, legs, shoulder (arthritis);states pain is achy, stiff, & spasm-like;calls then little pains;also c/o h/a;pt instructed to see MD;									U	10/16/1996	10/30/1996	14		PUB	PVT	cardiac med	NONE	coronary artery bypass AUG95, takes rehab	NONE~ ()~~~In patient		1						1	Arthralgia; Arthritis; Back pain; Headache; Hypertonia; Muscle spasms; Myalgia; Pain	FLU3~PFIZER\WYETH~4968172~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091961	11/13/1996	RI	38.0	38		F	10/31/1996	runny, itchy eyes, congestion, redness, swelling & itchiness @ inj site;									U	10/30/1996	10/30/1996	0		PVT	OTH	NONE	NONE	allergies-cats, dust, mites	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Lacrimal disorder; Pruritus; Rhinitis	FLU3~CONNAUGHT LABORATORIES~6F71266~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091964	11/13/1996	AK	52.0	52		M	11/06/1996	rash-sx;DPH tx sx lasted 12 days;										10/25/1996	10/25/1996	0		PVT	PVT			sulfur	~ ()~~~In patient		1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0091965	11/13/1996	CA	44.0	44		F	11/05/1996	pt recv vax 31OCT96 & 2NOV96 pt noticed red, hard, palm sized area around shot site, no pain or little pain;3NOV96 site began to resolve, on 4NOV cont to resolve;pt recv shot via pressurized gas gun;									Y	10/31/1996	11/02/1996	2	NONE	PVT	PUB	NONE	NONE	NONE;allergy to cats, dust	pt exp pruritus @ 24yr w/smallpox vax dose 1;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~6F71212~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091970	11/13/1996	MO	52.0	52		M	10/30/1996	4OCT96 or 5OCT96 noticed soreness & swelling in lt shoulder;7OCT96 noticed a localized red rash where vax had been given;10-15 sore on upper lt arm;no systemic complaints;11OCT96 to company MD for eval;30OCT96 raised pink areas on arm				Y					Y	10/01/1996	10/04/1996	3	NONE	OTH	PVT	Seldane, Beconase	NONE	allergy to molds & dust	~ ()~~~In patient		1						1	Injection site hypersensitivity; Oedema; Pain; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~6F71247~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091972	11/13/1996	WA	27.0	27		F		myalgias & fatigue for 3wk prior to vax;pt exp little red spots on abd;also mildly pruritic salmon colored maculo papular rash on trunk & arm;size up to 1cm diameter impression:pityriasis rosea;									N	10/24/1996	10/26/1996	2	NONE	OTH	OTH	NONE	probable viral synd	NONE	~ ()~~~In patient		1						1	Pruritus; Rash; Rash maculo-papular	FLU3~PARKE-DAVIS~01066P~1~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0091973	11/13/1996	MA	74.0	74		M	11/05/1996	very lifeless, no pain, chills, appetite good;couldn't get warm;no nausea;									Y	10/25/1996	10/26/1996	1	NONE	PVT	PUB		NONE	NONE	NONE~ ()~~~In patient		1						1	Chills; Hypotonia; Stupor	FLU3~CONNAUGHT LABORATORIES~6F71226~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~0001D~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0091975	11/13/1996	IN	51.0	50		F	11/07/1996	itching bad, red, enlarged, sore @ site of inj;never did this before, going up arm-took 2 DPH;									Y	10/09/1996	10/13/1996	4		OTH	OTH			asthma & a lot of allergies	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Pruritus	FLU3~CONNAUGHT LABORATORIES~6F71223~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091978	11/13/1996	CO	28.0	28		F	11/07/1996	near syncope 10min p/inj;residual dizziness x 1hr;happened @ work place;911 eval & sent to ER;no abnormalities found;released-cause of near syncope undetermined;				Y					Y	11/07/1996	11/07/1996	0	done in ER-all WNL per ER RN's report;	PUB	PUB	denied any-no verfication	NONE	mild developmental delay, very thin;	~ ()~~~In patient		1						1	Dizziness	FLU3~PFIZER\WYETH~00476P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091979	11/13/1996	CO	7.0	7		M	11/05/1996	mental status changes w/nocturnal screaming, laughing;daytime confusion & disorientation, hyperactivity;MRI & blood work nl;some subjective improvement 2wk later;sx started noc of vax;									U	10/21/1996	10/22/1996	1	MRI, bloodwork nl;	PUB	PUB		NONE	NONE	NONE~ ()~~~In patient		1						1	Agitation; Confusional state; Crying; Hyperkinesia; Thinking abnormal	FLU3~PFIZER\WYETH~4968165\~2~A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091980	11/13/1996	WY	48.0	48		M	11/06/1996	tingling & hypoasthesia lt arm 4 days p/flu vax;				Y						10/31/1996	11/02/1996	2		OTH	OTH				~ ()~~~In patient		1						1	Hypoaesthesia; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0091981	11/13/1996	RI	62.0	62		F	11/07/1996	45min p/vax pt felt fullness in ears, going down throat-eyes felt funny-no trouble swallowing epi given w/good effects;rescue called taken to ER;				Y					Y	11/07/1996	11/07/1996	0		OTH	OTH	DIazide	NONE	allergy to pollen	~ ()~~~In patient		1						1	Ear disorder; Eye disorder; Laryngospasm	FLU3~CONNAUGHT LABORATORIES~6F71273~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091982	11/13/1996	MI	51.0	51		F	11/08/1996	reported seeing lines going up & down in both eyes lasting 45min & sharp pain lt head;resolved spontaneously;also reported later that day of chills, fever & diarrhea;resolved the next day;									Y	10/29/1996	10/29/1996	0	NONE	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Chills; Diarrhoea; Headache; Pyrexia; Visual disturbance	FLU3~PFIZER\WYETH~6F71222~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091983	11/13/1996	OH	43.0	43		F	11/07/1996	local redness, swelling exacerbation asthma;				Y					Y	10/07/1996	10/10/1996	3		PVT	PVT	SloBId, Ventolin, Azmacort, lasix, K+, Coumadin	NONE	mitral valve replacement, asthma	~ ()~~~In patient		1						1	Asthma; Condition aggravated; Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4968203~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091984	11/13/1996	FL	68.0	68		F	11/07/1996	swollen upper arm-hard knot- 21OCT-24OCT;24OCT rash on stomach & breasts-still ongoing;									Y	10/21/1996	10/21/1996	0		OTH	OTH	NONE	NONE		~ ()~~~In patient		1						1	Oedema; Rash; Skin nodule	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0091985	11/13/1996	TX	37.0	37		F	10/30/1996	pt began exp h/a, warmth & tenderness @ inj site about 1hr p/vax;h/a cont off & on next day;red, indurated area next day, very tender to touch (beginning about 1 below inj site & extending 2 down & 4 across);31OCT96 BP 115/70-76-T97;				Y					Y	10/28/1996	10/28/1996	0		PUB	PVT	Premarin	NONE	PCN, Codeine, Vicodin, Pyridium	~ ()~~~In patient		1						1	Headache; Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4968161~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0091986	11/13/1996	TX	24.0	24		F	10/31/1996	bone ache, weak;									Y	10/27/1996	10/27/1996	0		PVT	PVT			hx of asthma	~ ()~~~In patient		1						1	Asthenia; Bone pain	FLU3~PFIZER\WYETH~4968161~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091988	11/13/1996	IN	41.0	41		F	11/07/1996	pain in lt deltoid began the next day & radiated up to neck;stiff neck for 24hr;tx w/Ibuprofen;resolved p/24hr;									Y	10/08/1996	10/11/1996	3	NONE	PUB	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Neck pain; Nuchal rigidity; Pain	FLU3~CONNAUGHT LABORATORIES~6F71223~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091990	11/13/1996	CO	70.0	69		F	11/06/1996	pt recv flu vax 16OCT96 & hives/tightness in throat;devel 18OCT96 prescribed the following: Medrol dose pack/DPH/Pepcid AC to drink plenty of fluids;t991. po;VS BP 160/84, 92, 16;									Y	10/16/1996	10/17/1996	1	NONE	PUB	OTH	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Hypertension; Hypoventilation; Laryngospasm; Pyrexia; Tachycardia; Urticaria	FLU3~PFIZER\WYETH~4968151~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091923	11/14/1996	MN	55.0	54		F	10/16/1996	devel redness, localized w/soreness & small blisters;									Y	10/15/1996	10/16/1996	1		PVT	PVT		NONE	allergic-wasp bite, ischemic heart dx, HTN, inc cholesterol	~ ()~~~In patient		1						1	Dermatitis bullous; Injection site hypersensitivity; Injection site pain	FLU3~CONNAUGHT LABORATORIES~6F71273~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~6F81204~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0091929	11/14/1996	MD	47.0	47		F	11/01/1996	pt recv vax 15OCT96 & rash, itching, red bumps began 20OCT96;spread over entire body-still having diff but less;began mild nerve med for gen itching approx 1mo ago (no rash);seen by MD & dermatology;given med;8NOV96 still bumps;				Y					N	10/15/1996	10/20/1996	5	blood test 23OCT96 liver & cholesterol fine;26OCT96 results pending;	PUB	PUB	mild nerve medicine-?name unk	NONE	allergy metal	NONE~ ()~~~In patient	MD96033	1						1	Pruritus; Rash; Rash maculo-papular	FLU3~MEDEVA PHARMA, LTD.~3026GB~3~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0091933	11/14/1996	TX	30.0	30		F	11/04/1996	pt recv vax 929AM & 1004AM pt c/o itchy arm & devel hives @ site of inj was given DPH;1020AM pt feels better rash gone, arm less itchy;									Y	11/04/1996	11/04/1996	0		OTH	PVT		NA	NA	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71239~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091934	11/14/1996	OK	52.0	52		F	11/05/1996	lt arm swelling, reddened, warm to touch & throbbing from 4PM to this AM 5NOV96 1130AM;took ASA last noc;encouraged no more ASA;took APAP or Ibuprofen;warm moist pack to site;									Y	11/04/1996	11/04/1996	0	NONE	PUB	PUB	HBP med	NONE	High BP	~ ()~~~In patient		1						1	Oedema; Pain; Rash; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0091935	11/14/1996	PA	31.0	31		F		pt recv vax & stated I'm having trouble breathing, my lips are numb my fingers are tingling;11:30AM nurse did physical assessment;P76, RR14, shallow resp & cold hands;11:31AM nurse administered; epi & told to dial 911;				Y					Y	11/01/1996	11/01/1996	0		OTH	OTH		NONE	NA	NONE~ ()~~~In patient		1						1	Dyspnoea; Hypoventilation; Paraesthesia; Peripheral vascular disorder	FLU3~CONNAUGHT LABORATORIES~6F71306~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0091992	11/15/1996		58.0	58		F		pt recv vax 15OCT96 & was hosp on 20OCT96 w/sx of numbness of the fingers & face & loss of coordination;pt condition dx as GBS but etiology from the flu had been r/o;pt stated that it is from a resp viral infect had 1-2wk prior to GBS					Y				U	10/15/1996	10/20/1996	5	NONE	OTH	OTH	unk		NONE reported	~ ()~~~In patient	ALI96585	1						1	Coordination abnormal; Guillain-Barre syndrome; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E3035GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0092056	11/15/1996	WI	43.0	43		F	11/08/1996	redness, swelling, pain arm circumfrential entire upper arm;back pain rt side down to waist;swollen lymph nodes (ax) rt deltoid area;				Y					Y	11/06/1996	11/06/1996	0		PUB	PUB	Otho cyclen	NONE	rare lung condition	denies~ ()~~~In patient	WI96055	1						1	Back pain; Lymphadenopathy; Oedema; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71322~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1627B~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0092057	11/15/1996	IN	71.0	71		M	11/07/1996	hardened area @ site/chills/noc sweats;rib cage painful;didn't feel like fever;									Y	10/11/1996	10/12/1996	1		PUB	PUB	BP pills, pepcid, eye gtts	allergic to PCN	emphysema, gall stones, inc BP, ulcers, lt lung partially collapsed	~ ()~~~In patient		1						1	Chills; Hyperhidrosis; Injection site mass; Pain	FLU3~CONNAUGHT LABORATORIES~6F71223~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092058	11/15/1996	OR	75.0	75		F	11/07/1996	11DEC94 knees gave out;15DEC94 fell again;dx GBS;arms & hands got extremely weak;totally helpless;neurologist verified dx;pt in wheel chair several months;p/4mo of GBS, autoimmune hepatitis followed;GGT inc;wt loss;fatigue, appetite loss;									N	11/30/1994	12/11/1994	11	liver function test;APR95 GGT was 4X nl;DEC95 all liver enzymes up ANA positive;	PVT	OTH	Synthroid	NONE	allergic to PCN	~ ()~~~In patient		1						1	Bone disorder; Gait disturbance; Guillain-Barre syndrome; Immune system disorder; Injury; Osteoporosis; Pain; Paraesthesia	FLU3~PARKE-DAVIS~00763P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0092059	11/15/1996	PA	58.0			F	10/21/1996	18OCT96 seen in ER for 3cm induration of lt deltoid;site of inj of flu shot on 16OCT96;										10/16/1996	10/16/1996	0		UNK	UNK				~ ()~~~In patient		1						1	Injection site mass	FLU3~PFIZER\WYETH~4968173~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092060	11/15/1996	PA	37.0	37		F	10/18/1996	pt recv vax & devel SOB & wheezing w/in 5min of vax;hx of asthma;felt like throat is closing over;seen in ER given med;observed in hosp under 23hr but pt refused & signed out;condition resolved as of 18OCT96; also recv 2 proventil rx					Y					10/16/1996	10/16/1996	0		UNK	UNK			hx of asthma;	~ ()~~~In patient		1						1	Asthma; Condition aggravated; Dyspnoea; Hypoxia; Laryngospasm	FLU3~PFIZER\WYETH~4968173~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0092061	11/15/1996	WY	27.0	27		F	10/25/1996	9AM pain began mid-area bottom of rt foot, radiating to rt knee;feels hot & pain shoots up to knee & thigh;very intense @ onset & pain cont x 10min;rt leg feels hot;sl achiness @ td inj site 23OCT96;foot to knee feels tingly;diff to s										10/23/1996	10/24/1996	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	WY9615	1						1	Hypokinesia; Injection site pain; Pain; Paraesthesia; Vasodilatation	FLU3~PFIZER\WYETH~4968162~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~6J81325~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0092063	11/15/1996	FL	59.0	58		F	09/30/1996	25SEP96 pt recv vax & 26SEP96 c/o inj site;p/exam noted by MD area red, warm to touch, firm, about 2 across;27SEP96 area on lt deltoid remains warm to touch, red & firm;ER MD ordered ATB;30SEP96 arm much better, no redness or swellin										09/25/1996	09/26/1996	1		UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~PFIZER\WYETH~4968179~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092064	11/15/1996	FL	39.0	39		F	09/30/1996	pt recv vax 24SEP96 & 25SEP96 lt deltoid area was swollen, firm & warm to touch;by 27SEP area had dec in size & firmness but still warm to touch;30SEP lt deltoid area looks much better no swelling or firmness noted;										09/24/1996	09/25/1996	1		UNK	UNK				~ ()~~~In patient		1						1	Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4968179~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092070	11/15/1996	MA	45.0			F	11/04/1996	pt recv vax 31OCT96 & had sore arm same day;next day had fever to 102, chills, cough, aching all over;called on Monday 4NOV96 to report;advised to call own MD;										10/31/1996	11/01/1996	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MA9613	1						1	Chills; Cough; Myalgia; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71226~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0001D~1~IM A~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0092071	11/15/1996	MA	46.0	46		F	11/07/1996	h/a, neck stiffness, joint aches, sore throat, chills, malaise;sx lasting more than 7 days;									Y	10/29/1996	10/30/1996	1		PUB	OTH		NONE	allergy to renographin dye	~ ()~~~In patient	MA9615	1						1	Arthralgia; Chills; Headache; Malaise; Nuchal rigidity; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~6F71226~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092073	11/15/1996	MN	60.0	60		F	11/07/1996	eyes became swollen, watery, red tongue became swollen, itchy throat became tight, closing feeling;				Y					Y	10/31/1996	10/31/1996	0	NONE	OTH	PVT	Synthroid	NONE	hypothyroid	~ ()~~~In patient		1						1	Conjunctivitis; Face oedema; Laryngospasm; Pruritus; Tongue oedema	FLU3~PARKE-DAVIS~01286P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0092074	11/15/1996	CA	52.0	52		F	10/29/1996	pt broke out w/rash w/sl fever, itching 3 days;itch, red conjunctiva;									Y	10/15/1996	10/20/1996	5	NONE	PVT	PVT	Tamoxifen, Ziac	NONE	NONE	NA~ ()~~~In patient		1						1	Conjunctivitis; Pruritus; Pyrexia; Rash	FLU3~PFIZER\WYETH~E30766D~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|MMR~MERCK & CO. INC.~0394D~1~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0092075	11/15/1996	PA	4.0	4		M	11/08/1996	large (11x12cm) area of non-tender induration, erythema w/onset 2 days (36hrs) p/vax;pt afeb;non-cellulitic, local rxn;									U	11/06/1996	11/08/1996	2	NONE	PVT	PVT	Synthroid, Intal	NONE	congenital hypothyroidism;mild asthma	~ ()~~~In patient		1						1	Injection site reaction; Rash; Skin nodule	FLU3~PFIZER\WYETH~4968200~3~~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092076	11/15/1996	WY				F		lt arm & hand edema;				Y						10/31/1996	11/01/1996	1		PVT	PVT			lupus	~ ()~~~In patient		1						1	Oedema peripheral	FLU3~MEDEVA PHARMA, LTD.~E3036GC~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0092077	11/15/1996	MO	39.0	39		F	11/07/1996	pt woke up 3AM;pt states was very sick to stomach & dizzy;pt stated if had anything on stomach, would have gotten sick about 5x that day;took 2-3 days a/felt better;									Y	10/11/1996	10/12/1996	1	NONE	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Dizziness; Dyspepsia; Nausea	FLUX~UNKNOWN MANUFACTURER~~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0090790	11/18/1996	GA	43.0	43		F	10/14/1996	pt awoke in early AM 9OCT96 lt axillary area swollen, very tender to touch, w/very limited (ROM);no fever, rash or redness noted;condition not relieved by warm compress, APAP, or gentle massage;advised to see MD;									Y	10/08/1996	10/09/1996	1	NONE	PUB	PUB		NONE	iodine allergy, hayfever, asthma	~ ()~~~In patient	GA96140	1						2	Hypokinesia; Oedema; Pain; Hypokinesia; Oedema; Pain	FLU3~MEDEVA PHARMA, LTD.~E3036GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~E3036GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0092037	11/18/1996	NY	34.0	34		M	11/12/1996	pt recv vax & exp rt shoulder & upper arm numbness, loss of balance & weakness in legs on 11NOV96, 10 days p/vax pt went to MD & dx w/GBS;pt hosp on 11NOV96;					Y			Y	N	11/01/1996	11/11/1996	10	NONE PROVIDED	PVT	OTH	Vanceril	NONE	history of asthma	~ ()~~~In patient	0010150960104	1						1	Coordination abnormal; Guillain-Barre syndrome; Hypotonia; Hypoxia; Myasthenic syndrome; Paraesthesia	FLU3~PARKE-DAVIS~00786P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation,Disabling	Influenza
0092042	11/18/1996	ND	19.0	19		F	10/30/1996	pt recv vax 16OCT95 & w/in 45min devel hypotension (80/35), tachycardia (pulse rate 100-110, resp 20), severe h/a, fever (initially 37.3  C), hypokalemia;n/v;pt acted like was in septic shock;adm to hosp;				Y	Y				U	10/16/1996	10/16/1996	0	initial CBC results unk;f/u CBC results: WBX 18,000;platelets 109,000, SGOT 100;potassium 2;	MIL	MIL	Vitamin B complex multivitamin	unk		~ ()~~~In patient	896304020L	1						1	Headache; Hypotension; Laboratory test abnormal; Pyrexia; Sepsis; Shock; Tachycardia; Vomiting; Dehydration; Headache; Hypotension; Leukopenia; Lymphocytosis; Sepsis; Tachycardia; Thrombocytopenia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|TYP~PFIZER\WYETH~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4968264~3~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|HEPA~SMITHKLINE BEECHAM~VHA490A6~1~~~HEP A (HAVRIX)~2|TYP~PFIZER\WYETH~4968090~1~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0092049	11/18/1996	CA	70.0	70		F	10/26/1996	pt recv vax & exp herpes lt side of face w/severe vesicles;fever & devel pain in lt ear & surrounding area;had shooting pain in lt ear & could not sleep on lt side w/face or head on pillow;tender;lt side of face swollen;								Y		10/15/1996	10/15/1996	0		UNK	UNK	DPH, Tamoxiphen, Inderal, multiple one a day vitamins;		breast lumpectomy 3 1/2yr ago;cardiac fibrillation;	~ ()~~~In patient		1						1	Dermatitis bullous; Ear pain; Face oedema; Insomnia; Pain; Pyrexia	FLU3~PFIZER\WYETH~4968146~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0092050	11/18/1996	IL				F	10/20/1996	acute severe vertigo (labrynthitis) beginning 36hr p/vax in MD office;					Y						10/19/1996		CBC, CT brain, survey 6; negative;	UNK	UNK	baby ASA		allergicbanertine;salivary gland CA >20 yr ago;no alcohol or tobacco;	~ ()~~~In patient		1						1	Vertigo; Vestibular disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0092051	11/18/1996	OH	45.0	45		F	11/07/1996	BP 122/94, P132, R28, T99.5, n/v, tingling, SOB, tachycardia secondary to dehydration began 5NOV96 pt adm for tx;t102.3 on admission;					Y				U	10/18/1996	11/05/1996	18		OTH	PUB	Sectral, Premarin, Provera	NONE	allergic septra;	NONE~ ()~~~In patient		1						1	Dehydration; Dyspnoea; Hypertension; Hyperventilation; Paraesthesia; Pyrexia; Tachycardia; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71308~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0092052	11/18/1996	WV	71.0	71		M	11/12/1996	4OCT96 arm/shoulder muscle pain lt spreading to rt side & descending to legs;c/o extreme muscle pain & gen edema;hosp;					Y	6			Y	10/03/1996	10/04/1996	1	unk	PUB	PUB	Multiple-heart meds-diabetic	NONE	heart disease, diabetes	NA~ ()~~~In patient	WV9626	1						1	Arthralgia; Myalgia; Oedema; Pain	FLU3~MEDEVA PHARMA, LTD.~E2986FB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0092054	11/18/1996		63.0	63		F		death	Y	11/06/1996							N	11/05/1996	11/06/1996	1		UNK	UNK				~ ()~~~In patient		1						1	Unevaluable event	FLU3~PARKE-DAVIS~00276P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0092055	11/18/1996	VA	40.0			F	11/11/1996	8 of 25 employees recv vax & 1 of which was severe;pt had immed systemic rxn (tachycardia-pulse reg, cold sweats, inc BP to 138/100, SOB, extremity tingling;911 was called & pt taken to ER-tx & released;			Y	Y						11/07/1996	11/07/1996	0		UNK	UNK				~ ()~~~In patient		1						1	Chills; Dyspnoea; Hyperhidrosis; Hypertension; Paraesthesia; Tachycardia	FLU3~PARKE-DAVIS~00376P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening	Influenza
0092088	11/18/1996	CA	39.0	39		F	11/12/1996	pt recv vax & exp oral rash 1wk post vax;also reported +- 100 bumps on buccal mucosa;bumps were definitely different from prev oral herpetic lesions;had herpetic lesions on roof of mouth p/oral rxn;									Y	10/03/1996	10/10/1996	7		PUB	PUB	Vitamin	Not reported	Not reported	~ ()~~~In patient	CA960111	1						1	Dermatitis bullous; Herpes simplex; Mucous membrane disorder	FLU3~CONNAUGHT LABORATORIES~6F71211~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092089	11/18/1996	NY	54.0	54		F	11/04/1996	arm swollen (quite);hive like rash on head, neck & trunk;c/o sl sore throat;									Y	11/01/1996	11/03/1996	2		PUB	OTH		NONE	pt question if might be allergic;	~ ()~~~In patient	NYS96076	1						1	Oedema peripheral; Pharyngitis; Rash; Urticaria	FLU3~PFIZER\WYETH~4968152~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092095	11/18/1996	NC	31.0	31		F	11/09/1996	w/in 13-15 p/vax pt c/o vertigo, slowly devel tightness in throat, diff swallowing, numbness feet & hands;BP 118/62, P88, R28;given med sz persisted;911 called;epi given;				Y					Y	10/31/1996	10/31/1996	0	NA	OTH	PVT			allergic to bee stings-episode 15yr ago;	NA~ ()~~~In patient		1						1	Dysphagia; Hyperventilation; Hypotension; Laryngospasm; Paraesthesia; Vertigo	FLU3~CONNAUGHT LABORATORIES~6F71248~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0092112	11/18/1996	GA	1.0	1	.0	F	10/31/1996	rash around mouth by morning had spread to entire body;rash red, flat, sl raised, non pruritic;no fever, no cough;+ blanching;				Y					Y	10/14/1996	10/28/1996	14	NONE	PUB	PUB	NONE	upper resp sx	HIV+, poss prenatal hep b exposure	NA~ ()~~~In patient	GA96145	1						1	Rash; Rash maculo-papular	FLU3~PFIZER\WYETH~4968166~1~IM~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|MMR~MERCK & CO. INC.~1171B~1~IM~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0092113	11/18/1996	IA	67.0	66		M	11/08/1996	t102, anorexia, diaphoresis, vomiting, malaise x 1wk;				Y					Y	10/17/1996	10/23/1996	6	NONE x/check for strep throat;	PUB	OTH		NONE	NA	NA~ ()~~~In patient		1						1	Anorexia; Hyperhidrosis; Malaise; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~686P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0092114	11/18/1996	ME	43.0	43		F	11/10/1996	high fever, broke out in hives, cough, severe h/a, loss of appetite-sick for two wk;									U	10/29/1996	10/31/1996	2		OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Anorexia; Cough; Headache; Malaise; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0092115	11/18/1996	WV	54.0	54		M	10/23/1996	pt recv vax Monday AM approx 10:00;Tuesday devel hives all over body-head to foot;intense itching;no resp problems;hives began dec in number & size by morning;ate eggs for breakfast became worse;no prev problems w/eggs;had flu shot w/o rxn;									N	10/21/1996	10/22/1996	1	NONE	PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	WV9625	1						1	Pruritus; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E29867B~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0092116	11/18/1996	MO	57.0	57		M	11/01/1996	began w/sx of pain to lt arm, next day pt states had numbness to lt arm from shoulder to hand, the next day pt states severe pain to lt arm, pain & numbness then subsided however pt c/o cont occassional milder pain & numbness to lt ar									N	10/04/1996	10/05/1996	1	NONE	PUB	OTH	Propulsid, Cardura, Proscar, vancenase, Atenolol, Pravachol, vasotec, Demadex, Slow-K, IMDUR, Prilosec, Asacol, Hydrochlorthiazide	pt c/o cold sx	allergy PCN;born w/6 toes each foot, deformities to fingers, 3MI, triple bypass	NONE~ ()~~~In patient	MO96064	1						1	Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~6F71239~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092117	11/18/1996	CA	29.0	29		F	11/06/1996	swelling @ site inj upper arm w/erythemic surrounding macules & plaques 1 to 2 cm tender afeb;				Y					Y	10/25/1996	10/26/1996	1	NONE	PVT	PVT	Birth control pills	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pain; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~0221D~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0092118	11/18/1996	ME	65.0	65		F	11/08/1996	24hr p/vax site & area-elbow red, swollen;pt c/o itching @ site;also s/o h/a;									Y	10/10/1996	10/11/1996	1	NONE	PVT	PVT	Darvocet, Mevacor, Xanax, Amytriptalliza, NT, Prilosec, Verapamil	NONE	hTNscoliosis;hyperlipademia;angina-dyspepsia;smoker;	~ ()~~~In patient		1						1	Headache; Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~MEDEVA PHARMA, LTD.~E2996FA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1076B~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0092120	11/18/1996	RI	57.0	57		F	11/05/1996	inj site became red, hot, sore w/in about 8hr over course of 1wk was a large (1x2) site red, sl swollen/painful then itchy;1wk later darker red/bruised appearance;aches & chills;									Y	10/30/1996	10/30/1996	0	NONE	UNK	UNK		NONE	HTN, allergies:molds, dust, plants, oats	NONE~ ()~~~In patient		1						1	Chills; Ecchymosis; Injection site hypersensitivity; Injection site pain; Myalgia; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71266`~3~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092122	11/18/1996	IN	43.0	43		F	11/12/1996	h/a characterized as severe nausea lasting 3hr;no tx sought;									Y	11/07/1996	11/07/1996	0		PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Headache; Nausea	FLU3~PFIZER\WYETH~4968265~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092123	11/18/1996	CA	40.0			F	11/15/1996	w/in 3hr of vax red, inflamed rt arm, from elbow to shoulder;edema 4+ lasted 4 days, pruritis, pain;tx w/ice, DPH;									Y	10/25/1996	10/25/1996	0	NONE	OTH	PVT	Premarin, Duril	NONE		~ ()~~~In patient		1						1	Oedema; Pain; Pruritus; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0092125	11/18/1996	NY	43.0	43		M	11/12/1996	began rash on Sunday palms of hands, under arms, groin;started DPH;saw MD on Monday who administered IV Pred;Cot on PO pred;				Y					Y	11/07/1996	11/10/1996	3	NONE	PUB	PVT	NONE	NONE	allergic sulfa drugs	~ ()~~~In patient		1						1	Rash; Rash	FLU3~PFIZER\WYETH~4968152~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968152~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0092128	11/18/1996	PA	34.0	34		F	11/07/1996	pt recv ax 30OCT96 woke up 31OCT96 w/red, pruritic hives & sore joints rt arm;took DPH;also c/o throat feels like is closing;31OCT had multiple red macular (no urticarial) rash on buttocks;face swollen;tingling of chin;dx allerg derma				Y					Y	10/30/1996	10/31/1996	1		UNK	UNK	PPD by Connaught lot# 243113 give 30OCT96;		NKA	~ ()~~~In patient		1						1	Arthralgia; Face oedema; Laryngospasm; Paraesthesia; Pruritus; Rash maculo-papular; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71266~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0092129	11/18/1996	VA				F	11/11/1996	7 patients devel large welt (approx 1 1/2inches), redness, swelling & pain @ inj site;all pt had negative allergy hx to eggs;														UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~00376P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0092130	11/18/1996	VA				F	11/11/1996	7 patients devel large welt (approx 1 1/2 inches), redness, swelling & pain @ inj site; all pt had negative allergy hx to eggs;										11/07/1996	11/07/1996	0		UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~00376P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0092131	11/18/1996	VA				F	11/11/1996	7 patients devel large welt (approx 1 1/2inches), redness, swelling & pain @ inj site;all pt had negative allergy history to eggs;										11/07/1996	11/07/1996	0		UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~00376P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0092132	11/18/1996	VA				F	11/11/1996	7 patients devel large welt (approx 1 1/2inches), redness, swelling, & pain @ inj site;all employees had negative allergy history to eggs;										11/07/1996	11/07/1996	0		UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~00376P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0092133	11/18/1996	VA				F	11/11/1996	7 patients devel large welt (approx 1 1/2 inches), redness, swelling, & pain @ inj site;all pt had negative allergy hx to eggs;										11/07/1996	11/07/1996	0		UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~00376P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0092134	11/18/1996	VA				F	11/11/1996	7 patients devel large welt (approx 1 1/2inches), redness, swelling & pain @ inj site;all pt had negative allergy history to eggs;										11/07/1996	11/07/1996	0		UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~00376P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0092135	11/18/1996	VA				F	11/11/1996	seven patients devel large welt (approx 1 1/2 inches), redness, swelling, pain @ inj site;all pt had negative allergy hx to eggs;										11/07/1996	11/07/1996	0		UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~00376P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0091616	11/19/1996	MN	68.0	68		F	11/05/1996	26OCT adm to hosp 3wk prior had flu;2wk prior devel canker sore in mouth-unable to eat;20OCT devel h/a, backache, vomiting & adm to hosp;24OCT growing weakness in legs & arms & head;26OCT plasmapheresed & intubated for airway GBS;				Y	Y					10/09/1996	10/16/1996	7	CSF lyme negative; HSV negative;EBV 26OCT;VCA IGG 1:640;VCA IGM <1:10, EBNA >1:10;	PUB	OTH	Synthroid;Antibiotic for acne	NONE	NONE	~ ()~~~In patient	MN96042B	1						2	Apnoea; Asthenia; Guillain-Barre syndrome; Anorexia; Back pain; Guillain-Barre syndrome; Headache; Mouth ulceration; Myasthenic syndrome; Vomiting	FLU3~PFIZER\WYETH~4968163~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968163~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0092081	11/19/1996	MA	53.0	53		F	11/12/1996	acute demyelinating polyneuropathy-GBS onset 3wk p/vax; supportive care/rehab;					Y	8			U	10/09/1996	10/26/1996	17	EMG/NCS consistent w/GBS;LP acellular, protein 88	PUB	PUB		NONE	NOT KNOWN	~ ()~~~In patient	MA9621	1						1	Guillain-Barre syndrome; Neuropathy; Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~6F71226~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71226~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0092085	11/19/1996	SC	91.0	91		F	11/15/1996	sx of paralysis, unable to hold head up;loss of coordination;memory loss;sx occurred same day of vax including a cold;nurse was called in-who suggested that MD see pt immed				Y	Y				Y	10/30/1996	10/30/1996	0	scan test	OTH	OTH	Coumadin, Vasotec	NONE	high bloood pressure	NONE~ ()~~~In patient		1						1	Amnesia; Coordination abnormal; Hypotonia; Paralysis; Pharyngitis; Rhinitis	FLU3~PARKE-DAVIS~00986P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0092138	11/19/1996	IL	66.0	66		M	11/04/1996	rt arm red, warm, swelling around elbow was painful on Saturday;feels better now but moving up arm;3NOV96 inc pain-swelling;4NOV96 no pain today, swelling dec to being sl swollen;									Y	11/01/1996	11/02/1996	1		PUB	PUB	NA	NONE		NA~ ()~~~In patient	IL960109	1						1	Oedema peripheral; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71246~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~432688~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0092141	11/19/1996	MS	45.0	45		F	11/04/1996	local rxn w/redness, wheal, itching occurred 15-20min p/vax;applied ice to site;pt took DPH;itching & burning subsided;									Y	10/29/1996	10/29/1996	0		PUB	PUB		NONE	NONE	NONE~ ()~~~In patient	MS96046	1						1	Injection site hypersensitivity; Injection site pain; Pruritus	FLU3~MEDEVA PHARMA, LTD.~E3086GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~436024~1~SC~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0092142	11/19/1996	MS	39.0	39		F	11/06/1996	pt recv vax 4NOV96 & 830AM became nauseated p/2hr;then flushed, weak kneed, SOB, heart palpitations;taken to hosp ER;recv DPH;saw FNP 5NOV96;				Y					Y	11/04/1996	11/04/1996	0	NA	PUB	UNK	NONE	NONE	allergic to Pericodan-no other condition	pt exp several local rxn @ site arm red/swollen @ 29yr w/Typhoid;~ ()~~~In patient	MS96047	1						1	Dyspnoea; Myasthenic syndrome; Nausea; Palpitations; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3080GE~2~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1284B~UNK~~LA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~5H71003~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0092143	11/19/1996	OH	61.0	61		F	10/29/1996	pt recv vax & arm was feeling sore & pt had limited mobility p/vax;pt had a hard time lifting arm up over head;tingling down the arm;pt seen by MD & given med;				Y					U	10/12/1996	10/12/1996	0		PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient	OH96141	1						1	Hypokinesia; Insomnia; Movement disorder; Myalgia; Myasthenic syndrome; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E3096GB~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0092144	11/19/1996	OH	48.0	48		F	10/28/1996	pt's mom states pt exp immed pain in arm followed by erythema & swelling of arm from inj site to wrist that evening;pt states several days later swelling & pain had subsided;refused to return to clinic for eval;										10/21/1996	10/21/1996	0	NONE	PUB	PUB	NONE	NONE	stroke, cerebal palsey, allergy PCN	pt exp pain, swelling @ 38yrs old w/flu vax unk dose;~ ()~~~In patient	OH96142	1						1	Injection site hypersensitivity; Injection site oedema; Oedema; Pain; Rash	FLU3~CONNAUGHT LABORATORIES~6F71308~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092150	11/19/1996	CA	37.0	37		F	11/11/1996	erythema 4cm x 6cm for 3+ days, intense itching, mild nausea beginning 10NOV;									U	11/08/1996	11/08/1996	0	NONE	OTH	OTH		NONE	NONE	~ ()~~~In patient		1						1	Nausea; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~6F71237~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092151	11/19/1996	TX	7.0	7		F	11/04/1996	pt devel hives p/flu vax (16 min post vax);tx epi & DPH;				Y					Y	10/30/1996	10/30/1996	0		OTH	PVT	vitamins	NONE	NONE	~ ()~~~In patient		1						1	Urticaria	FLU3~PFIZER\WYETH~4968141~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092152	11/19/1996	OH	73.0	73		F		pt recv vax & exp bad head cold, watering eyes, runny nose, all the drainage was uncomfortable & kept in bed;last 2 days severe cough, flu type again, sore throat, drainage eyes, cough;									Y	10/09/1996	10/31/1996	22		OTH	OTH		cold @ time of vax		pt exp inj site pain w/flu vax w/prev vaccines;~ ()~~~In patient		1						1	Cough; Influenza; Lacrimal disorder; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0092155	11/19/1996	TX	48.0	48		F	11/09/1996	2 days p/vax pt had a red discolored mark 3 long & 2 wide coming out of the area where the flus hot was given;still has mark now;									N	10/23/1996	10/24/1996	1		OTH	OTH		NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~01286P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0092156	11/19/1996	TX	55.0	55		F	10/10/1996	pt recv vax 210PM pt returned to vax area @ 235PM w/ c/o dizziness, h/a, diaphoresis, pallor, BP 120/92, P104, R20;BP p/5min 136/92, P108 ;pt pale, profusely diaphoretic, no SOB;pulse weak, thready;hands numb;redness of wrists & arms;									Y	10/10/1996	10/10/1996	0	NONE	OTH	OTH		NONE	unk	~ ()~~~In patient		1						1	Dizziness; Headache; Hypertension; Pallor; Paraesthesia; Peripheral vascular disorder; Tachycardia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71275~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092159	11/19/1996	TX	19.0	19		F	11/07/1996	2 days post vax swollen glands, flu like sx, fatigue, weakness, dizziness, & multiple chancre sores inside mouth;				Y					Y	11/01/1996	11/03/1996	2	dec WBC count	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Dizziness; Influenza; Leukopenia; Lymphadenopathy; Mouth ulceration	FLU3~PFIZER\WYETH~4968161~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092161	11/19/1996	NE	32.0	32		F	10/03/1996	lt deltoid raised & red, feverish, achiness;size 5x5;									Y	09/25/1996	09/25/1996	0		OTH	OTH	NONE	NONE	asthma	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Myalgia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71239~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092162	11/19/1996	MA	53.0	53		M	11/12/1996	chills, lightheaded, body aches & h/a 7NOV96 approx 1030AM to 8NOV96 took ASA & rest;									Y	11/05/1996	11/07/1996	2	NONE	PUB	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Chills; Dizziness; Headache; Myalgia	FLU3~PFIZER\WYETH~4968209~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092163	11/19/1996	NE	26.0	25		F	10/31/1996	lt deltoid redden, feverish, 2cmx 1cm;									Y	09/25/1996	09/25/1996	0		OTH	OTH		NA	NA	~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71239~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092164	11/19/1996	IA	37.0	37		F	11/01/1996	lt deltoid redden & feverish 2x2cm hard;									Y	09/25/1996	09/26/1996	1		OTH	OTH	Premarin, vitamins	NONE	NA	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71239~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092165	11/19/1996	OR	71.0	71		F	11/13/1996	arm became very red & hot in area where flu shot was given;this was the very next day & it also itched all the time;this has lasted the full two wk after;									Y	10/29/1996				OTH	OTH		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4968192~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092167	11/19/1996	MI	7.0	6		M	11/12/1996	fever (T max 105), vomiting, h/a, coughing, spasms;date of vax 6NOV96;onset of sx 8NOV96;seen in ER 9NOV96 dx tracheal bronchitis;				Y					Y	11/06/1996	11/08/1996	2		PVT	OTH		NONE		~ ()~~~In patient		1						1	Bronchitis; Cough; Headache; Infection; Muscle spasms; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71288~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0092168	11/19/1996	IL	38.0			F	11/07/1996	tongue swelling, pruritus of tongue;				Y					Y		10/22/1996			OTH	OTH				~ ()~~~In patient		1						1	Pruritus; Tongue oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0092169	11/19/1996	WA	39.0	39		F	11/12/1996	rash & itching lt arm;lump in throat, SOB, tachycardia;				Y					U	11/12/1996	11/12/1996	0	NONE	OTH	OTH	Bentyl	NONE	Crohn's disease	~ ()~~~In patient		1						1	Dysphagia; Dyspnoea; Pruritus; Rash; Tachycardia	FLU3~PARKE-DAVIS~00786P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0092171	11/19/1996	CA	25.0	25		F	11/07/1996	persistent vomiting beginning approx 5hr p/vax given;IV fluids & Tigan supp & Phenergan & transported to hosp;				Y					U	11/06/1996	11/06/1996	0	NONE	OTH	PVT	diet pills		alleged allergy to percocet, sodium pentothal	~ ()~~~In patient		1						1	Dehydration; Vomiting	FLU3~PFIZER\WYETH~4968164~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092173	11/19/1996	OH	40.0	40		F	11/09/1996	redness & swelling @ site;site was warm & sore;limb was sore to elbow & into shoulder for about 3 days;had very mild flu sx for 1 day;site still shows redness;									Y	10/30/1996	10/31/1996	1	NONE	OTH	PVT	NONE	mold allergies active	mold allergies	NONE~ ()~~~In patient		1						1	Influenza; Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0092174	11/19/1996	NC	58.0	58		F	11/15/1996	exp aching & soreness for 2wk p/vax;MD prescribed ATB but it just upset pt stomach;									Y	10/09/1996	10/11/1996	2		OTH	OTH		no illness		~ ()~~~In patient		1						1	Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0092177	11/19/1996	MN	51.0	51		F	11/04/1996	250PM 1NOV96 pt recv vax & returned +- 20min later flushed, sore throat, hoarse voice, anxious, epi given;BP 120/62, P88;									Y	11/01/1996	11/01/1996	0	NA	PUB	OTH	unk	HTn	allergies mlk, beef, wheat	~ ()~~~In patient	MN96044	1						1	Agitation; Dysphonia; Hypotension; Pharyngitis; Vasodilatation	FLU3~PFIZER\WYETH~4968205~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092178	11/19/1996	FL	62.0	62		F	11/13/1996	red, feverish spot on lt deltoid the size of a quarter on onset inc in size to 3inches in diameter above & below inj area;sl puffy & swollen;				Y					U	11/11/1996	11/12/1996	1		PVT	PVT	Prilosec;Diazide, slow K	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PARKE-DAVIS~00576P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0092183	11/19/1996	CA	6.0	6		M	11/11/1996	rash appearing inferior to varivax inj site;									Y	10/29/1996	11/07/1996	9	NONE	PVT	PUB	Zantac, Periactin	NONE	s/p Subarachoid cyst w/developmental delay;cortical blindness secondary to #1;	~ ()~~~In patient		1						1	Injection site hypersensitivity	DTAP~PFIZER\WYETH~440763~5~IM~RL~DTAP (ACEL-IMUNE)~1|FLU3~CONNAUGHT LABORATORIES~6F71292~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0880D~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0775D~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0092185	11/19/1996	NY	44.0	44		F	11/12/1996	1hr p/vax pt devel h/a @ corner of head, followed by hypesthesia & fullnss of lt malar region & back to lt ear;described as novocaine @ the dentist;sx began diminishing p/2hr, completely gone p/11hr;never had significant neurologic de									Y	10/29/1996	10/29/1996	0	neurologic exam nl, cranial nerves WNL;	OTH	OTH	NONE	NONE	NONE	pt exp h/a w/flu vax;~ ()~~~In patient		1						1	Headache; Hypoaesthesia	FLU3~CONNAUGHT LABORATORIES~6F71284~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092186	11/19/1996	MA	84.0	84		M	11/13/1996	lt forearm pain beginning the day p/flu vax to 2wk after;									Y	10/28/1996	10/29/1996	1		PVT	PVT	NONE	NONE	allergies to horses, dogs, cats	NONE~ ()~~~In patient		1						1	Pain; Skin nodule; Condition aggravated; Neoplasm; Pain; Skin nodule	FLU3~PFIZER\WYETH~4968174~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968174~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0092187	11/19/1996	NE	45.0	45		F	11/11/1996	hives & itching @ inj site;projectile vomiting, fever >101, fatigue;									Y	11/06/1996	11/07/1996	1		OTH	OTH			allergies-sulfa, tetanus, formaldehyde	~ ()~~~In patient		1						1	Asthenia; Injection site hypersensitivity; Pruritus; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092188	11/19/1996	WI	70.0	70		F	11/08/1996	fever, chills, aches, pains, ear ache & every tooth in head ached;myalgia cont weeks;toothache all winter; neuralgia all winter;insomnia, head got sickness through DEC; pt states allergies all getting worse & worse;will not take flu v									Y	11/08/1995	11/08/1995	0	NONE	PUB	OTH		only pre-existing complaints;	trigeminal neuralgia, lactose intolernace, seasonal allergies, arthritis	pt had rxn w/prior flu shots;~ ()~~~In patient		1						1	Chills; Gastrointestinal disorder; Headache; Insomnia; Myalgia; Neuralgia; Pain; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E2825HC~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0092136	11/20/1996	KS	63.0			F	11/11/1996	pt recv vax 5NOV96  & that evening pt died;pt had a hx of heart disease;pt was not allergic to eggs & had prev recv the flu vax w/o rxn;pt was not taking Coumadin;responsible MD does not think the death was r/t vax;	Y	11/05/1996								11/05/1996	11/05/1996	0	NONE	PVT	OTH	NONE	NONE	hx of heart disease?NKDA/no allergy to eggs;not taking coumadin/prev recv flu vax w/o rxn;	~ ()~~~In patient	0010150960083	1						1	Unevaluable event	FLU3~PARKE-DAVIS~00276P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0092195	11/20/1996	NY	73.0	73		F	11/16/1996	every year for the past 5yr pt noticed a sore throat & cold sx 1wk p/flu vax; no tx;									Y	10/30/1996	11/05/1996	6	NONE	PUB	OTH	Hydrochlorthiazide, Atenolol, Synthroid	NONE	NONE	pt exp sore throat & cold sx @ 70 w/flu vax x last 5yr age 60,70,71,72~ ()~~~In patient	NYS96078	1						1	Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0092196	11/20/1996	MS	55.0	55		F	11/14/1996	swelling, itching, rash @ site of inj;gen itching;									Y	11/07/1996	11/07/1996	0	NONE	PVT	PVT		NONE	had rash of undetermined origin 2wk prior	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4968163~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092214	11/20/1996	PA	16.0	16		M	11/11/1996	pt recv vax & devel a lt facial droop, lt eye watering & inability to close eye on 7NOV96 2 days p/vax;pt went to MD & dx w/Bell's palsy;				Y					N	11/05/1996	11/07/1996	2	NONE	PVT	OTH	Flovent, Serevent, Claritin, Proventil	NONE	asthma, allerg rhinitis;	~ ()~~~In patient	0010150960090	1						1	Eye disorder; Facial palsy; Lacrimal disorder; Paraesthesia	FLU3~PARKE-DAVIS~00376P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0092216	11/20/1996	OK	83.0			F	11/14/1996	both upper & otter arms w/red areas, warm to touch, upper arms edematous from above elbow to middle humerus 29OCT96;itching 30OCT96;									Y	10/26/1996	10/29/1996	3		PUB	PVT	Feosol, centrum, Elavil, Tolectin< Propulsid, Vitamin C, Mobisyl oint;Santyl oint., APAP, Novahistine DH, Lortab;	poor netritional status	allergies: morphine, sulfonamides-rheumatoid arthritis, iron deficit, anemia;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4968163~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0092217	11/20/1996	MA	21.0	21		F	11/14/1996	migraine 4hr p/vax student hlth ctr 30OCT96-still had migraine & nausea;h/a sl better 31OCT96;neuro w/u -went home;				Y						10/25/1996	10/25/1996	0	CAT Scan 2NOV96;	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	NH96028	1						1	Headache; Migraine; Nausea; Dehydration; Headache; Malaise; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71273~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71273~1~SC~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0092220	11/20/1996	MN	23.0	23		F	11/13/1996	itchiness, flushing, inc R-24, inc P100, shakiness, apprehension, weakness in legs;epi given;				Y						11/13/1996	11/13/1996	0		OTH	OTH		NONE	sulfa	~ ()~~~In patient		1						1	Agitation; Anxiety; Hyperventilation; Myasthenic syndrome; Pruritus; Tachycardia; Tremor; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71273~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0092221	11/20/1996	OR	40.0	40		F	11/01/1996	approx 1hr p/vax pt became very flushed from face to mid chest;cheeks were the most affected & also had small hives;no itching, some facial tingling;nurse had left when sx began;									Y	10/10/1996	10/10/1996	0	NONE	OTH	PVT	Amitryptyline for h/a	NONE	NONE x/migraine h/a	NONE~ ()~~~In patient		1						1	Paraesthesia; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71237~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092222	11/20/1996	OR	26.0	26		M		felt rapid heart rate, felt had a fever, faint, felt bad x 45min;then resolved over next 15min;p/1hr period, felt nl;									Y	10/31/1996	11/01/1996	1	NONE	OTH	PVT	NONE	NONE	states allergic to cats;allergic to eggs as a child-now no problem;	NONE~ ()~~~In patient		1						1	Malaise; Pyrexia; Syncope; Tachycardia	FLU3~CONNAUGHT LABORATORIES~6F71237~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092223	11/20/1996	MO	74.0	74		F	11/14/1996	c/o chills, weakness, light headedness in mid Pm p/inj;saw MD;dx w/kidney infect & fluid in ear;									Y	10/24/1996	10/24/1996	0	urine test;blood test for cholesterol	PUB	PVT		NONE	NONE-other than dust	~ ()~~~In patient		1						1	Asthenia; Chills; Dizziness; Ear disorder; Infection; Renal impairment	FLU3~CONNAUGHT LABORATORIES~5771239~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092224	11/20/1996	ID	37.0	37		F	11/14/1996	lt shoulder tender to touch over deltoid & active/passive ROM, tender axillae;dx inflammation lt deltoid secondary to flu shot;				Y					U	11/05/1996	11/05/1996	0	NONE	PVT	PVT	NONE	lt arm sore	sulfa	pt exp arm swollen w/TD;~ ()~~~In patient		1						1	Hypokinesia; Injection site inflammation; Injection site pain; Pain	FLU3~PFIZER\WYETH~4968188~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092229	11/20/1996	WA	52.0	51		F	11/14/1996	arm swollen, red, welt approx 1x3:;lasted about 1 1/2wk;									Y	10/22/1996	10/22/1996	0	25OCT96 observation by pvt MD only;	OTH	PVT	Atenolal, Premarin, Triam/HCTZ	NONE	allergies weeds, grass, sage, trees, etc	pt had rxn to 1st allergy shot DEC94~ ()~~~In patient		1						1	Oedema peripheral; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6771316~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092230	11/20/1996	ME	39.0			F	11/13/1996	lymph nodes in arm & neck very swollen & extremely tender;muscles in arm are very sore;pain wakes pt @ noc;no fever;									U	10/23/1996	10/24/1996	1	NONE	PUB	PUB	NA	NA	NA	~ ()~~~In patient	ME96019	1						1	Lymphadenopathy; Myalgia; Pain	FLU3~PFIZER\WYETH~4968205~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092247	11/21/1996	WA	58.0	58		F	11/15/1996	mo fever, pt complained of severe headaches w/pain radiating down her back; bp118/112; neurological symptoms, couldn't walk in a straight line; nausea, vomit; dx as sterile meningitis				Y					Y	10/01/1996	10/04/1996	3	CBC;CT scan;Chem battery EKG	PVT	PVT	Zocor;Premarin	NONE	MS, allergy	NA~ ()~~~In patient		1						1	Asthenia; Back pain; Gait disturbance; Headache; Hypertension; Meningitis; Neuropathy; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71320~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0092249	11/21/1996	FL	60.0	60		F	11/15/1996	pt recv vax 10Am approx 3hr p/vax became itchy & devel rash from groin to knees;24hr later cont to have itching/rash;took DPH;recv cortisone inj 13NOV96;									Y	11/14/1996	11/14/1996	0	NA	PUB	PUB	Cadazide, ASA, VIt E, Scolaxin, amutriphline;	NONE	bee stings, narcotics;	~ ()~~~In patient	FL97031	1						1	Pruritus; Rash	FLU3~MEDEVA PHARMA, LTD.~E3106HB~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0092250	11/21/1996	MT	29.0	29		F	11/01/1996	pt recv vax 30OCT96 & c/o immed itching @ site;evening of 31OCT96 cont became red & swollen to the size of fifty cent piece;c/o whole arm aching & going numb;rubra 3/4 diameter sl amt tenderness;redness changed to purplish brown colo									U	10/30/1996	10/30/1996	0	recommended skin testing for eggs/thimeresol per MD	PUB	OTH	NONE	NONE	stomach problems-surgical repair; HX OF MIGRAINES	NONE~ ()~~~In patient	MT96021	1						1	Arthralgia; Coordination abnormal; Fibrosis tendinous; Injection site hypersensitivity; Myopathy; Paraesthesia; Serum sickness; Syncope	FLU3~PFIZER\WYETH~4968164~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~433403~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0092253	11/21/1996	TN	73.0	73		M	11/04/1996	pt recv vax  10OCT96 woke up AM 11OCT96 w/severe h/a & unable to get out of bed d/t the pain;pain was all over head & cont;h/a was so bad that it affected pt hearing some & made pt eyes sore;seen by MD who gave med which made h/a wors				Y					Y	10/10/1996	10/11/1996	1	NONE	PUB	PUB	micronase, Dyazide, Clinoril, Synthroid	No acute illness	allergic to PCN;hx HTN, diabetes, thyroid disorder	NONE~ ()~~~In patient	TN96085	1						1	Deafness transitory; Eye pain; Headache; Hypokinesia; Pain	FLU3~CONNAUGHT LABORATORIES~6F71307~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1626B~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0092257	11/21/1996	OH	18.0	18		M	11/19/1996	c/o lightheadedness, & stomachache p/flu vax this AM;									Y	11/14/1996	11/14/1996	0		OTH	PVT	?unk	NONE	unk	~ ()~~~In patient		1						1	Abdominal pain; Dizziness	FLU3~CONNAUGHT LABORATORIES~6F71277~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092259	11/21/1996	PA	50.0	49		F	11/15/1996	redness & swelling 3inches x 1 1/2inches diameter, hot, arm sore to move;									Y	11/14/1996	11/14/1996	0		PUB	PVT	Dyazide, zantac, estrace	NONE	medications, Bactrim, Flagly & DVP dye;	NONE~ ()~~~In patient		1						1	Myalgia; Oedema; Vasodilatation	FLU3~PFIZER\WYETH~4968173~2~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091475	11/22/1996	NY	58.0	57		F	11/14/1996	gradual muscle weakness;pt adm to ICU & started on Immune globulin;paralysis subsided;p in rehab 14NOV96;LP to dx GBS by neurologist;			Y	Y	Y	20	Y	Y	U	10/08/1996	10/18/1996	10	LP to dx GBS by neurologist	PVT	PVT	NONE	NONE	NONE	NA~ ()~~~In patient		1						2	Asthenia; Guillain-Barre syndrome; Guillain-Barre syndrome; Myasthenic syndrome; Pain; Paralysis	FLU3~CONNAUGHT LABORATORIES~6F71255~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71255~2~SC~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0092217	11/22/1996	MA	21.0	21		U		malaise, h/a, vomiting, dehydration hosp x 2 day;					Y	2				10/25/1996	10/25/1996	0	labs WNL	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						2	Headache; Migraine; Nausea; Dehydration; Headache; Malaise; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71273~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71273~1~SC~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0092242	11/22/1996	AR	39.0	39		F	11/01/1996	21OCT sore arm, 22OCT sore arm, fever 102, itching called pt called hlth unit spoke w/RN advised to see MD;rash;went to MD w/whelps & itching given med;through up, went to ER;whelps got worse;				Y	Y	3			Y	10/21/1996	10/22/1996	1	NA	OTH	OTH	NA	NONE	ASA, PCN, cylomycin, Ibuprofen;	NA~ ()~~~In patient	AR9679	1						1	Myalgia; Pruritus; Pyrexia; Rash; Urticaria; Vomiting	FLU3~CONNAUGHT LABORATORIES~6H71307~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0092243	11/22/1996	NC	14.0	14		F	10/30/1996	pt feels, weak, passed out @ school x 2, devel h/a, CT, MRI of head negative;exam nl, chem & CBC nl, neurologist eval nl;pt exp w/med w/o help;mom w/migraines;					Y	1			N	10/08/1996	10/10/1996	2	CT, MRI of head negative;exam nl, chem & CBC nl, neurologist eval nl;	PVT	PVT	NONE	NONE	irritable bowel synd, anxiety, migraine, h/a	NONE~ ()~~~In patient	NC96120	1						1	Asthenia; Headache; Syncope	FLU3~PARKE-DAVIS~00966P~2~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0092245	11/22/1996	TX	69.0			U	10/24/1996	pt recv vax 11OCT96 & w/in 1hr had numbness & tingling in lt face, arm & leg;progressed to severe vomiting;presented to ER & dx w/intercerebral bleed;MD states probably no correlation between two events, family believes vax precipitat			Y							10/11/1996	10/11/1996	0		UNK	UNK			allergy to codeine	~ ()~~~In patient		1						1	Cerebral haemorrhage; Paraesthesia; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71275~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0092261	11/22/1996	MA				U		the problem was observed 20OCT96;ER pt exp sudden onset of SOB, vomiting, diarrhea;pt reports that has had itching since flu vax given 18OCT96;				Y						10/18/1996				UNK	UNK				~ ()~~~In patient		1						1	Diarrhoea; Dyspnoea; Pruritus; Vomiting	FLU3~PFIZER\WYETH~4968173~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092263	11/22/1996	WA	72.0	72		M	11/18/1996	local swelling @ site of inj about 10 diameter-pneumovax side;									Y	10/22/1996	10/24/1996	2	no pneumovax NOV91;	PVT	PVT	Lotensen, Testosterone, AdalappCC, ASA	NONE	NONE	~ ()~~~In patient		1						1	Injection site oedema	FLU3~PFIZER\WYETH~4968143~6~SC~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~434243~2~SC~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0092265	11/22/1996	MN	64.0	64		F		pt recv vax & pt stated nurse had diff getting airgun to fire;shot painful, blood immed w/arm pain;leg & head pain by bed time;joints sore;fatigue;tired, low energy, hot shivering, arm diff to raise;pain lower back & pain inj site;									Y	11/06/1996	11/06/1996	0	NA	OTH	UNK	Provera, Pravachol, Zestril, Premarin, Triamterine	NONE	high cholesterol,high BP, tissue fluid	NONE~ ()~~~In patient		1						1	Arthralgia; Asthenia; Back pain; Headache; Hypokinesia; Injection site pain; Myalgia; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E3026GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0092267	11/22/1996	NY	44.0	44		F	11/17/1996	31OCT96 PM immed p/vax pt felt wave go down arm to elbow, to back & neck;achy through 4NOV;4NOV PM  10:00 same area became itchy, rash appeared;15NOV96 rash intensified, used topical DPH;									Y	10/31/1996	11/04/1996	4	NONE	PUB	OTH	Lo-ovral, Synthroid	NONE	hypothyroidism treated w/oral meds;	NONE~ ()~~~In patient		1						1	Myalgia; Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0092268	11/22/1996	NV	74.0	74		M	11/18/1996	heavy cough, fever & chills;finally, chills stopped on 11NOV96, cough still w/pt;									Y	10/31/1996	11/02/1996	2		PVT	UNK				~ ()~~~In patient		1						1	Cough; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E3086GD~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0092269	11/22/1996	AL	53.0	53		F	11/18/1996	pain @ inj site that evening;has now spread to entire upper arm, burning pain-constant-unrelieved by APAP-hot & cold compresses-went to ER told it would be OK 2-3 days p/shot;3wk now & no relief;				Y					N	10/28/1996	10/28/1996	0		MIL	OTH		NONE	allergic to sulfa-arthritis	pt exp numb legs @ 33yr old w/flu vax;~ ()~~~In patient		1						1	Injection site pain; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0092272	11/22/1996	NM	80.0	80		F	11/06/1996	day p/vax arm swelled, & red w/welt 3/4 the way around arm;hot to touch, pain shoulder & neck;lasted for 1wk;states it was arm in which pneumovax was given;									Y	10/22/1996	10/23/1996	1	NA	OTH	OTH	NONE	NA	NKDA, thyroid	~ ()~~~In patient	NM96038	1						1	Arthralgia; Neck pain; Oedema peripheral; Skin nodule; Vasodilatation	FLU3~PFIZER\WYETH~4968161~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~431585~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0092273	11/22/1996	SC	62.0	62		F	11/11/1996	pt recv vax 22NOV96 & devel Bell's palsy on 31OCT96 tx Pred;									N	10/22/1996	10/31/1996	9	NONE	PVT	PVT	Estrace	NONE		~ ()~~~In patient		1						1	Facial palsy	FLU3~CONNAUGHT LABORATORIES~6F71217~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092277	11/22/1996	NC	27.0	27		F	11/04/1996	pt came to clinic c/o redness & swelling (3 1/2 x 2 1/2 area) approx 2 above lt elbow;flu vax should have been given in deltoid muscle;appeared to have been given in SQ tissue;pt stated area itched & a little painful;advised to see									Y	11/03/1996	11/03/1996	0	NONE	PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient	NC96127	1						1	Myalgia; Oedema peripheral; Pruritus; Vasodilatation	FLU3~PARKE-DAVIS~00296P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0092284	11/22/1996	NC	68.0	68		F	11/05/1996	localized redness of rt upper arm-began around 9PM 3NOV96;soreness cont 5NOV96 swollen lymph node;									Y	11/03/1996	11/03/1996	0		PUB	PUB	Procardia;endoral & pred	NONE	NONE	pt exp localized redness @ 10yr old w/typhoid vax q yr;~ ()~~~In patient	NC96119	1						1	Injection site hypersensitivity; Lymphadenopathy; Myalgia	FLU3~PARKE-DAVIS~00296P~7+~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~436769~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0092285	11/22/1996	NC	44.0	44		F	11/04/1996	fever 103 x 24hr;then fever of 100 x 24hr;achiness all over;severe soreness of arm inj administered;whelps on arm (4-5 days) where inj given;pt self administered pain med & APAP;did not see MD;									Y	10/29/1996	10/29/1996	0	NA	PUB	PVT	NONE	NONE	environmental allergies, antiinflammatory med (?name);	NONE~ ()~~~In patient	NC96118	1						1	Injection site hypersensitivity; Injection site pain; Myalgia; Pyrexia	FLU3~PARKE-DAVIS~00586P~2~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1627B~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0086665	11/25/1996	TN	54.0	54		F	11/04/1996	pt recv vax & devel acute bronchial plexopathy (assumed to be acute brachial plexopathy) & median nerve damage to the rt shoulder & arm;it is also alleged that pt suffered permanent disability;				Y				Y	Y	10/20/1995	10/20/1995	0		OTH	OTH	Premarin, Provera	unk	aortic and tricuspid insufficiency; left ventricular hypertrophy	~ ()~~~In patient	896312019L	1						2	Hypokinesia; Myasthenic syndrome; Neuropathy; Pain; Paraesthesia; Hypokinesia; Lung disorder; Myasthenic syndrome; Neuropathy; Osteoarthritis; Pain; Tendon disorder	FLU3~PFIZER\WYETH~4958072~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4958072~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Disabling	Influenza
0091230	11/25/1996	AR	55.0	55		M	11/06/1996	1NOV96 joint & muscle pain, fever 102.7, dizziness, tinnitus;ATB given;7NOV96 temp nl, joint & muscle pain gone;dizziness, tinnitus, deafness, & congestion persist;				Y					N	10/15/1996	10/15/1996	0		PUB	UNK	Paxil	NONE	gantrisin;panic disorder	NONE~ ()~~~In patient	AR9674	1						2	Abdominal pain; Arthralgia; Dizziness; Dysuria; Myalgia; Pyrexia; Tinnitus; Urinary retention; Arthralgia; Deafness; Dizziness; Myalgia; Pyrexia; Rhinitis; Tinnitus	FLU3~CONNAUGHT LABORATORIES~6F71307~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71307~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0092287	11/25/1996	OH	50.0	50		F	10/31/1996	pt recv vax & exp aching in legs followed by numbness;pt was unable to stand & was taken to ER;ER MD dx GBS;pt was then seen by neurologist who hosp pt for diagnostic eval & d/c pt;				Y	Y	3			Y	10/28/1996	10/30/1996	2	MRI-results pending;LP results pending;	PUB	PVT	unk	none	no known allergies	~ ()~~~In patient	896310016L	1						1	Gait disturbance; Hypokinesia; Myalgia; Myasthenic syndrome; Myelitis; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4968190~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0092288	11/25/1996	WI	34.0	34		F	10/30/1996	pt recv vax & devel numbness of the feet & hands;13 days post vax pt hosp & treating MD dx GBS, although diagnostic eval is not complete;pt is currently in ICU for resp precautions;					Y				N	10/16/1996				PUB	OTH	unk	unk		~ ()~~~In patient	896306003L	1						1	Guillain-Barre syndrome; Hypoxia; Paraesthesia	FLU3~PFIZER\WYETH~4968187~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0092289	11/25/1996	PA	57.0	57		M	11/18/1996	7 days p/vax sx began w/ h/a, rt arm weakness & ataxia;progressively worsening weakness requiring hosp admission 2NOV96;					Y	16			U	10/22/1996	10/29/1996	7	MRI negative for CNS mass;CSF tap 4NOV acute demyelination polyneuropathy consistent w/jGBS;	PVT	OTH	Cardura	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Coordination abnormal; Guillain-Barre syndrome; Headache; Myasthenic syndrome; Neuropathy	FLU3~CONNAUGHT LABORATORIES~6F71235~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0092311	11/25/1996	NY	58.0	58		F	11/01/1996	area 4x5 red, swollen, hot, no pain noted 31OCT96;1030PM ice packs applied & tavist taken;no apparent chang 31OCT96 PM p/speaking w/MD;remains same today;will have MD check on 5NOV unless worsens or becomes painful;										10/30/1996	10/30/1996	0	NONE	PUB	PUB	Astinmacort;allergy shots q wk	NONE	allergy molds, spores, cat, goat	~ ()~~~In patient	NYS97035	1						1	Oedema; Vasodilatation	FLU3~PFIZER\WYETH~4968173~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092313	11/25/1996	IN	56.0	56		F	11/15/1996	pt recv flu vax 13NOV96 & noticed redness, swelling & itching that evening;returned 15NOV96 w/red, indurated area @ 4x12cm w/2 1/2 cm ecchymotic area bout inj site;tx w/med; & cool compress;									Y	11/13/1996	11/13/1996	0	NONE DONE	PVT	PUB	Klonopin, Premarin, Norotriptoline	NONE	bee sting, motrin, seafood, contrast dyes	~ ()~~~In patient	IN97012	1						1	Ecchymosis; Injection site hypersensitivity; Injection site mass; Oedema; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71288~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092325	11/25/1996	NC	52.0	52		F	11/12/1996	3 days p/vax pt c/o redness, swollen arm, & rash down lt arm;reported on 12NOV96-stated no rash anywhere else;reported confusion along w/above sx;									Y	10/31/1996	11/03/1996	3	NA	PUB	PUB	Firounal	did not indicate any	unk	~ ()~~~In patient	NC96134	1						1	Confusional state; Oedema; Rash; Vasodilatation	FLU3~PFIZER\WYETH~68204~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092328	11/25/1996	NC	76.0	76		M	11/12/1996	lt arm sore started 11NOV96 unable to turn steering wheel, afeb, no edema, no erythema;yellow bruise 3-4mm, deltoid muscle, very hard when arm is relaxed;										11/08/1996	11/11/1996	3		PUB	OTH			allergy sulfa drugs;diabetes type II, arthritis	~ ()~~~In patient	NC96128	1						1	Ecchymosis; Hypokinesia; Myalgia; Pain; Skin nodule	FLU3~PARKE-DAVIS~00276P~7+~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0092329	11/25/1996	IA	50.0	50		F	11/19/1996	4x6cm red, swollen deltoid 72hr p/vax given;Motrin was prescribed for pain, swelling;				Y					Y	11/05/1996	11/08/1996	3	pt will reccv allergy testing @ a later date;	PVT	PVT		NONE-check-up	NONE	~ ()~~~In patient	IA96038	1						1	Oedema peripheral; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71306~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~6K81354~2~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0092331	11/25/1996	ND	54.0	54		F	10/30/1996	exp pain & burning p/vax by 7OCT96 was unable to move rt arm-unable to hold anything w/weight (i.e. coffee cup) in rt hand;felt weak, congested in lungs, dry cough;pt seen by MD;pt cont to have bruise & area tender;could not work d/t pain				Y					N	10/04/1996	10/04/1996	0		PUB	PUB	Premarin	NONE	allergy to chocolate, coconut, yeast, molds, oils	pt exp similar but severe rxn p/2nd dose of hepatitis~ ()~~~In patient	ND96023	1						1	Asthenia; Ecchymosis; Hypokinesia; Injection site mass; Injection site pain; Lung disorder; Myasthenic syndrome; Pain	FLU3~PFIZER\WYETH~4968184~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092332	11/25/1996	ND	65.0	65		F	11/13/1996	inj site swollen hot & red;fever 100;									Y	11/11/1996	11/13/1996	2		PVT	PVT			allergy sulfa	~ ()~~~In patient	ND96022	1						1	Injection site hypersensitivity; Injection site oedema; Pyrexia	FLU3~PFIZER\WYETH~4968178~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~394936~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0092333	11/25/1996	WA	75.0	74		F	10/23/1996	starting 48hr p/vax exp nasal congestion, non productive cough, weak;									Y	10/17/1996	10/19/1996	2		PVT	PVT	Pzsil, Meclizine, Cataflan, Synthroid, Pepcid, Beconase inhaler, Pyrazinzene SR PRN		seasonal allergies, hypothyroid, osteoarthritis	~ ()~~~In patient		1						1	Asthenia; Cough; Rhinitis	FLU3~CONNAUGHT LABORATORIES~6F71320~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092335	11/25/1996	NE	13.0	13		M	11/18/1996	mom called MD office 3 days p/vax;pt said hands & fingers were tingling & numb;having diff lifting things;on exam neuro assessment nl x/forearm, radial side had a rectangular area of loss of sensation 2x6 cm;				Y					U	10/28/1996	11/01/1996	4	exam only	PVT	PVT	NONE	NONE	asthma	~ ()~~~In patient		1						1	Hypokinesia; Neuropathy; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~6F71288~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0092336	11/25/1996	OH	30.0	29		F	11/19/1996	swelling, pain in joints, diff walking, closing hand;postural arthopathy;symmetrical polyarthritis;				Y					U	10/30/1996	11/02/1996	3		OTH	PVT		unk-had been assisting neighbor w/flu s/s	family hx arthritis	~ ()~~~In patient		1						1	Arthralgia; Arthritis; Gait disturbance; Hypokinesia; Osteoarthritis	FLU3~PFIZER\WYETH~4968168~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092337	11/25/1996	NY	49.0	49		M	11/18/1996	pt recv vax 23OCT96 @ 830AM;@ noon same day felt cold & devel shakes;returned to clinic 7AM next AM w/rigors & temp 101.4;sent to hosp adm to r/o sepsis;had nl WBC & all cult negative;initially w/mild hypotension responded quickly to									Y	10/23/1996	10/23/1996	0	blood cult negative;CXR negative;WBC nl;UA cult negative;	OTH	PVT	Nitroglycerin, Indur	NONE	no allergies, CAD w/angina since JUN96	UNK~ ()~~~In patient		1						1	Chills; Hypotension; Pyrexia; Tremor	FLU3~CONNAUGHT LABORATORIES~6F71297~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092340	11/25/1996	AR	44.0	43		F	10/16/1996	dizziness, blurred vision, syncope, rash, itchy eyes;									Y	10/16/1996	10/16/1996	0	NONE	PUB	PUB	NONE	NONE	tachycardia;allergy codeine	~ ()~~~In patient	AR9676	1						1	Amblyopia; Dizziness; Pruritus; Rash; Syncope	FLU3~CONNAUGHT LABORATORIES~6F71307~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092342	11/25/1996	AZ	65.0	65		M	11/18/1996	tenderness @ site w/swelling for 1st 3 days then swelling resolved but inc soreness extending down arm to elbow & up into shoulder;has cont since inj;pt will be treated for pain to f/u w/MD;				Y						10/21/1996	10/24/1996	3		PUB	PUB	NONE	NONE	deafness d/t umups illness @ age 11	NONE~ ()~~~In patient	AZ9630	1						1	Injection site oedema; Injection site pain; Myalgia	FLU3~PFIZER\WYETH~4968162~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092346	11/25/1996	FL	3.0	3		M	11/18/1996	pt recv vax & 48hr p/vax devel flu, rash, pruritus, t101.4;										11/14/1996	11/16/1996	2		UNK	UNK		NONE	NONE	NONE~ ()~~~In patient		1						1	Influenza; Pruritus; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0092348	11/25/1996	MA	43.0	43		F	11/12/1996	pt recv vax 31OCT96 930AM & 950AM returned pale, no diaphoresis, anxious, BP 160/100, P88, R16;c/o dizziness, tightness in chest, AP 88 regular, resp 24, inc anxiety;sx did not subside by 10:15 sent to ER via ambulance;BP 150/102, AP 92				Y					Y	10/31/1996	10/31/1996	0		UNK	PUB	Fulvian PG	NA	mitral valve prolapse	NONE~ ()~~~In patient		1						1	Anxiety; Chest pain; Dizziness; Hypertension; Hyperventilation; Pallor	FLU3~CONNAUGHT LABORATORIES~6F71226~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0092349	11/25/1996	MA	39.0	39		F	11/07/1996	pt recv vax & later felt funny-dizzy, then passed out;co-worker reported body shaking & eyes rolling;taken to ER via amb;5NOV96 pt reported was sneezing & w/cold-like sx;6NOV96 whole body weak, h/a, scratchy throat, tired;				Y					Y	11/04/1996	11/04/1996	0	CAT SCAN, blood was drawn everything is all right;	PUB	PUB	Esgic	NONE	migraine h/a;	~ ()~~~In patient	MA9619	1						1	Asthenia; Dizziness; Gaze palsy; Headache; Pharyngitis; Rhinitis; Syncope; Tremor	FLU3~CONNAUGHT LABORATORIES~6F71226~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0092358	11/25/1996	AK	41.0	41		U		24hr p/vax fever 101, chills, joint aches in bed for 24hr;									Y	10/08/1996	10/09/1996	1	NONE	PUB	PUB		none		pt exp similar s/s age 40 w/flu vax 95-96 fever, chills, arthralgia~ ()~~~In patient	AK9630	1						1	Arthralgia; Pyrexia	FLU3~PFIZER\WYETH~9468167~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092359	11/25/1996	AK	35.0	35		F	10/17/1996	h/a started a few hrs p/vax then red swollen inj site, neck, joint muscle pain, fever, sweats;				Y					Y	10/10/1996	10/11/1996	1	NONE	PUB	PUB	NONE	NONE	latex allergy	~ ()~~~In patient	AK9631	1						1	Arthralgia; Headache; Hyperhidrosis; Injection site hypersensitivity; Injection site oedema; Myalgia; Neck pain; Pyrexia	FLU3~PFIZER\WYETH~9468167~1~A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092360	11/25/1996	AK	46.0	46		F	10/15/1996	10OCT96 530PM site swelling (quarter size);11OCT96 630AM site 4 times larger w/chils, t96.8;11AM t97.2 w/chills, feeling bad; 5 1/2cm wheal;t012, BP elevated, rash, SOB;sent to ER;facial swelling, inj site pain;				Y					Y	10/10/1996	10/10/1996	0	CBC	OTH	PUB			asthma & environmental allergies, bees	pt exp fever & swelling @ 40yr old w/tetanus booster;~ ()~~~In patient	AK9632	1						1	Dyspnoea; Face oedema; Hypertension; Injection site mass; Injection site oedema; Injection site pain; Oedema peripheral; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E30260B~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~~1~SC A~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0092370	11/25/1996	AK	63.0	63		F	10/04/1996	fever to 100.4, aching, nausea, dry heaves, low energy, bad h/a, sore throat, cough, high pulse to 111, high BP per home kit, sore rt upper arm, arm is redness;									Y	10/01/1996	10/01/1996	0	NOT DONE	UNK	PUB	OGEN, ATENDOBIN RP, T20F	NONE	MILD hypertensive	NONE~ ()~~~In patient	AK9627	1						1	Cough; Headache; Hypertension; Injection site pain; Pharyngitis; Pyrexia; Tachycardia; Vomiting	FLU3~PFIZER\WYETH~0849251~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1626B~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0092371	11/25/1996	AK	30.0	30		F	10/04/1996	pt recv vax 2OCT96 1130AM 21OCT96 10PM noticed itching on arm where flu vax given  red hard-lump (small) & hives around inj site;deltoid bruised;										10/02/1996	10/02/1996	0	NONE	OTH	PUB	NONE	NONE	NONE	~ ()~~~In patient	AK9628	1						1	Ecchymosis; Injection site hypersensitivity; Injection site mass; Pruritus; Urticaria	FLU3~PFIZER\WYETH~40849351~1~~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1626B~1~~LL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0092377	11/25/1996	SD	60.0	60		M	10/17/1996	chills, legs shaking, fever 101.8 w/weird dreams;fever & chills lasted several hr;									Y	10/15/1996	10/15/1996	0		PUB	PUB		NONE	NONE	NA~ ()~~~In patient	SD96013	1						1	Abnormal dreams; Chills; Pyrexia; Tremor	FLU3~CONNAUGHT LABORATORIES~6F71273~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092378	11/25/1996	SD	12.0	12		F	11/04/1996	MOC called 4NOV96 stated pt awoke 1NOV96 w/chest pain, severe SOB became progressively worse resulting in visit to hosp ER;per MOC MD on duty flet sx were vax related;				Y					Y	10/28/1996	11/01/1996	4	EKG, x-ray;	PUB	PUB	NONE	NONE-breathing	NONE NKA	NA~ ()~~~In patient	SD96014	1						1	Chest pain; Dyspnoea	FLU3~CONNAUGHT LABORATORIES~6F71316~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0092379	11/25/1996	SD	45.0	45		F	11/01/1996	arrythmia;involuntary movements occasionally to lt arm;flushed feeling initially p/vax;h/a 6hr p/affecting rt eye;some SOB though not initially afterwards;									Y	10/29/1996	10/29/1996	0		PUB	PUB	prednizone, estrogen, spirolactone, asacol	NONE	sulfa-allergy, hx of collitis	pt exp rxn @ 45 w/flu vax dose 1;~ ()~~~In patient	SD96015	1						1	Arrhythmia; Dyspnoea; Eye disorder; Headache; Movement disorder; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71273~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092385	11/25/1996	GA	58.0	58		M	10/28/1996	started feeling hot 6 dasy p/vax-7th day has redness around area w/swelling;having tenderness-swelling 16mm length redness w/approx same size in width;referred to MD p/soaks today;									N	10/21/1996	10/27/1996	6	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	GA96151	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PARKE-DAVIS~00686P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~431803~1~IM~LA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~6A81017~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0092387	11/25/1996	GA	52.0	52		F	11/06/1996	27OCT96 pt c/o body aches, cough, fever;2NOV96 c/o flu sx w/sore throat;4NOV96 MD saw pt stated had flu-?flu shot but would not say for sure that was rxn;6NOV96 pt states has allergy to chicken feathers;also has allergic asthma;				Y					N	10/24/1996	10/27/1996	3	blood profile @ MD office	PUB	PUB	Vitamins Synthroid, Premarin, Coragid, Zoloft, RItalin	NONE	allergies seafood, environment allergies, allergic vodeine;asthma;MVP, back surgery, Epstein Barr virus, Firbomyalgia;	pt exp rxn 94-95 @ age 50/51 w/flu vax;~ ()~~~In patient	GA96153	1						1	Cough; Influenza; Myalgia; Pharyngitis; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E3036GA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0092388	11/25/1996	GA	23.0	23		F	11/06/1996	local rxn consisting of edema & redness @ site in rt deltoid;redness migrated almost down to pt rt elbow;exp no SOB;pulse rate 85;did have hives;ice applied & epi given;				Y					Y	10/28/1996	10/28/1996	0	NONE	OTH	PUB	NONE	NONE	pt gave verbal hx of no allergies	unk~ ()~~~In patient	GA96154	1						1	Injection site hypersensitivity; Injection site oedema; Urticaria; Vasodilatation	FLU3~PARKE-DAVIS~01386P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0092392	11/25/1996	MI	60.0	60		F	10/30/1996	pt recv flu shot 28OCT 530PM redness, swelling, pain started in 1hr p/shot;w/in 1 day swelled to size of baseball, hot to touch & itches;redness & swelling spreading to back of lt & rt sides;									Y	10/28/1996	10/28/1996	0	NONE	PUB	PUB	NONE	NONE	NONE	pt recv flu vax last yr & TD & devel redness, swelling & itching in 1980's;~ ()~~~In patient	MI96168	1						1	Oedema peripheral; Pain; Pruritus; Skin nodule; Vasodilatation	FLU3~PFIZER\WYETH~4968172~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092393	11/25/1996	MI	69.0	69		F	10/21/1996	rt arm became swollen, red, hot 2 diameter by later afternoon of 15OCT96;purple-1' center;felt flu sx (fever, weak, fatigue, h/a);t101-102 16OCT96;APAP used 15OCT95-16OCT96;advised to use ice/cold compresses @ site & call pvt MD;									N	10/15/1996	10/15/1996	0	NONE	PUB	PUB	Premarin	NONE	NONE	NA~ ()~~~In patient	MI96167	1						1	Asthenia; Ecchymosis; Headache; Injection site hypersensitivity; Injection site oedema; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4968172~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~428504~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0092394	11/25/1996	MI	40.0	40		F	10/24/1996	1/2hr p/vax pt exp nausea couple of hr later exp SOB, gen aching & h/a;awoke @ 4AM 24OCT w/severe back pain & ha/;didn't take temp but feels has low grade temp & ears hurt;									Y	10/23/1996	10/23/1996	0		PUB	UNK		denies any prev illness;	bilat mastectomy 6yr ago;auto immune disease p/leaking of post op silicone implants	~ ()~~~In patient	MI96166	1						1	Back pain; Dyspnoea; Ear pain; Headache; Myalgia; Nausea; Pyrexia	FLU3~PFIZER\WYETH~4968204~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092395	11/25/1996	MI	44.0	44		M	11/04/1996	pt says p/vax fever, went way up (did not take temp); had hallucinations & couldn't walk;also had terrible h/a;									Y	10/31/1996	11/01/1996	1	NONE	PUB	UNK	NONE	NONE	bad back-7 back surgeries	NONE~ ()~~~In patient	MI96165	1						1	Hallucination; Headache; Hypokinesia; Pyrexia	FLU3~PFIZER\WYETH~4968204~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092396	11/25/1996	MI	59.0	59		F	10/08/1996	rt arm became warm & swollen by late afternoon entire arm from elbow to shoulder swollen;became discolored-1wk later knot the size of an orange  @ inj site;									Y	09/27/1996	09/27/1996	0		PVT	PVT	Clariten, Micor K, Aldomet, Hygroton;	NONE	HTN	~ ()~~~In patient	MI96164	1						1	Injection site mass; Oedema peripheral; Skin discolouration; Vasodilatation	FLU3~PARKE-DAVIS~00966P~4~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1626B~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0092397	11/25/1996	MI	67.0	67		F	11/01/1996	lt arm approx 3 circular, reddened area w/soreness, states whole lt side is sore;also was nauseated, h/a & had a nose bleed, chills;this MA noticed reddened area & went to MD given rx for med; & use hot/cold packs;				Y					Y	10/30/1996	10/30/1996	0	NONE	PUB	PUB	Cardene;B/p bid, Zocor, Chol;	NONE	inc BP; inc cholesterol	NONE~ ()~~~In patient	MI96163	1						1	Chills; Epistaxis; Headache; Myalgia; Nausea; Pain; Vasodilatation	FLU3~PARKE-DAVIS~00176P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~436822~1~SC~LA~PNEUMO (PNU-IMUNE)~1|TD~MICHIGAN DEPT PUB HLTH~TD6132B~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0092399	11/25/1996	MI	57.0	57		F	11/04/1996	wednesday evening sever chills, t102, swelling of site of vax;(swelling about double sauce dish size);swelling into lymph nodes & breast area;seen by MD given med;				Y					Y	10/01/1996	10/02/1996	1		PUB	PUB			allergic to ceclor	~ ()~~~In patient	MI96161	1						1	Chills; Injection site oedema; Lymphadenopathy; Pyrexia	FLU3~PARKE-DAVIS~00176P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~436820~1~SC~RA~PNEUMO (PNU-IMUNE)~1|TD~MICHIGAN DEPT PUB HLTH~TD6132B~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0090756	11/26/1996	KS	65.0	65		F	11/14/1996	shingles post 3hr from vax;muscle spasms & then broke out on lt side front center to back center;took ASA 4 days could not sleep;broke out red area where had been hurting, pain-tingling;dx shingles;				Y					N	10/03/1996	10/03/1996	0	x-rays, bloodwork;	OTH	PVT	Synthyroid, Premarin, Provara	NONE	sulfa & Iodine allergy	~ ()~~~In patient		1						2	Abdominal pain; Back pain; Herpes zoster; Insomnia; Myalgia; Pain; Herpes zoster; Hypertonia; Insomnia; Pain; Paraesthesia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~6F71247~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0091711	11/26/1996	FL	49.0	49		F	11/01/1996	t102, lightheaded-woke up MN, throat closed up from MN to 3AM;sprayed throat & used vics;coughed;6AM lt arm was swollen & red blotches size of tennis ball;1NOV96 throat scratchy, congested;3 yr ago lt side of body stiff p/vax;			Y						N	10/30/1996	10/30/1996	0		PUB	OTH	Synthroid, Premarin	NONE	PCN/thyroid/mediterrain anemia/coagulopathy/liver damage	pt exp lt side body still @ 46 w/flu dose 1;~ ()~~~In patient	FL96081	1						2	Injection site hypersensitivity; Injection site pain; Laryngospasm; Lung disorder; Myalgia; Oedema; Pharyngitis; Pyrexia; Cough; Dizziness; Laryngospasm; Oedema; Pharyngitis; Pyrexia; Rash maculo-papular; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~MEDEVA PHARMA, LTD.~E3106HB~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Life Threatening	Influenza
0092081	11/26/1996	MA	53.0	53		F	11/19/1996	pt recv vax  9OCT96 & on 25OCT96 pt presented w/s/s of GBS w/dx confirmed by MD;				Y					U	10/09/1996	10/25/1996	16		UNK	UNK				~ ()~~~In patient	CO6974	1						2	Guillain-Barre syndrome; Neuropathy; Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~6F71226~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71226~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0092297	11/26/1996	MS	41.0	41		M		?GBS?;			Y	Y	Y	14	Y		U	10/22/1996	11/05/1996	14	unk	OTH	PUB	unk	NONE	NONE	~ ()~~~In patient		1						1	Guillain-Barre syndrome; Hypokinesia	FLU3~CONNAUGHT LABORATORIES~6F71285~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0092300	11/26/1996	OR	29.0	29		F	11/14/1996	pt recv vax 5NOV96 & 7NOV96 pt had trouble swallowing;next day exp SOB & throat was constricting;pt returned to MD office & was given adrenalin & DPH;rx pred;pt recovered;			Y	Y					Y	11/05/1996	11/07/1996	2	NONE REPORTED	PVT	PVT	NONE	NONE	seasonal allergies	~ ()~~~In patient	0010150960108	1						1	Dysphagia; Dyspnoea; Laryngospasm; Tongue oedema	FLU3~PARKE-DAVIS~20586P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening	Influenza
0092301	11/26/1996	TX				F		pt recv vax tested positive for two viruses known as HTLV-1 & HTLV-2 commonly known as HIV;repeated testing by an infect disease specialist determined pt did not have these two viruses;pt claims suffered loss of ability to work;								Y	U	11/01/1994	11/01/1996	731	NONE	OTH	OTH	unk	NONE	NONE	~ ()~~~In patient	0010150960115	1						1	Laboratory test abnormal	FLU3~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0092304	11/26/1996	NM	68.0	68		F	11/19/1996	approx 2hr p//vax became SOB leading to not being ble to breath @ all;was then taken to hosp ER;			Y	Y	Y	3			Y	11/09/1996	11/09/1996	0	CXR negative;VO scan neagtive;	OTH	OTH	Acuysress, Estrolid, Folatic acid;ditragrese	NA	NA	pt exp edema, rash @ 28yr w/polio dose 1;~ ()~~~In patient		1						1	Apnoea; Dyspnoea	FLU3~CONNAUGHT LABORATORIES~6F71320~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0092308	11/26/1996	MD	67.0	67		F	11/22/1996	pt devel itching, hives throughout body-edema of face & hands;itching & hives began several hr p/vax;to MD 12OCT96 prescription for pred & zyrtec;				Y	Y				U	10/11/1996	10/11/1996	0		OTH	OTH				~ ()~~~In patient		1						1	Face oedema; Oedema peripheral; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71266~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0092401	11/26/1996	SC	43.0	43		F	11/21/1996	transverse myelitis w/paraplegia, sensory loss to T3 & bowel;MRI head, C-spine, T-spine, L-S spine LP;pt transferred to nurse for tertiary care facility;				Y	Y			Y	U	11/14/1996	11/15/1996	1	MRI's & LP completel nl;	OTH	OTH	Adalat;Niacin	NONE	HTN, hyperlipidemia	~ ()~~~In patient		1						1	Faecal incontinence; Gastrointestinal disorder; Myelitis; Paraplegia; Urinary incontinence	FLU3~MEDEVA PHARMA, LTD.~E3096GB~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0092402	11/26/1996	CO	43.0	43		F	11/02/1996	stated felt tired PM p/shot;3 days p/shot began to have muscle pain which inc in severity & was very painful;10 days post vax shot began to have joint pain, - hips, but also in other joints (back, shoulder, ankles), malaise, heavy & weak					Y				U	10/08/1996	10/11/1996	3	CBC, rheumatitis, arthritis, titer & work-up all WNL	PUB	OTH	Estrogen/progesteron	sl cold-no fever	NONE	NONE~ ()~~~In patient	CO96065	1						1	Arthralgia; Asthenia; Back pain; Malaise; Myalgia; Myasthenic syndrome; Pain	FLU3~PFIZER\WYETH~40849351~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0092405	11/26/1996	FL				F	11/15/1996	bilat optic neuritis;IV & PO steroids;				Y					Y	10/08/1996	10/28/1996	20	MRi	PUB	PUB	NONE	NONE	NONE	NA~ ()~~~In patient	FL96083	1						1	Optic neuritis	FLU3~CONNAUGHT LABORATORIES~6F71308~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0092406	11/26/1996	MD	37.0	37		M	10/28/1996	24OCT96 pt w/pain rt upper arm, then swelling, redness progressed to purple discoloration & skin eruptions;no oozing, but hot;swelling was 1/2 diameter, pains in the joints on the same side of body, muscle aches, anorexia, sweat, tiredness				Y					U	10/23/1996	10/24/1996	1	28OCT96	PUB	PUB	NONE	NONE	hayfever, all pollen, environmental dust, mold	~ ()~~~In patient	MD96043	1						1	Anorexia; Arthralgia; Arthropathy; Asthenia; Injection site oedema; Injection site pain; Myalgia; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E2986FA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~390966~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0092409	11/26/1996	OH	57.0	57		F	11/18/1996	pt exp chills, t102, body aches, h/a, gen malaise 24hr post vax;									N	11/13/1996	11/14/1996	1	NONE	PUB	PUB	BP meds;hormones	NONE	Aspirin & sulfa drugs	~ ()~~~In patient		1						1	Chills; Headache; Malaise; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0092412	11/26/1996	NY	62.0	62		M	11/23/1996	heaviness in chest-dx w/bronchial asthma-dx pneumonia;diff breathing;				Y					N	11/01/1996	11/07/1996	6	cardiogram-CXR-positive pneumonia	OTH	PUB	Augmenten, Preventil, asthma cort	NONE	diabetes	pt exp pneumonia/tumor removed from lung w/flu vax @ 52yr old;~ ()~~~In patient		1						1	Asthma; Bronchitis; Chest pain; Dyspnoea; Infection; Pneumonia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0092413	11/26/1996	MA				M		shaky for a few days post vax;w/in 3 days pt back to nl;									Y	11/17/1996	11/17/1996	0	NONE	PUB	PUB	various meds	NONE	heart attack or sz-not sure?	~ ()~~~In patient		1						1	Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0092415	11/26/1996	KY				U	11/18/1996	4 pt recv vax & devel bell's  palsy;									U				NONE REPORTED	OTH	OTH	unk	unk	unk	~ ()~~~In patient	0010150960126	1						1	Facial palsy	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0092416	11/26/1996	KY				U	11/18/1996	4 pt recv vax & devel bell's palsy;									U				NONE REPORTED	OTH	OTH	unk	unk	unk	~ ()~~~In patient	0010150960125	1						1	Facial palsy	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0092417	11/26/1996	KY				U	11/18/1996	4 pt recv vax & devel bell's palsy;									U				NONE REPORTED	OTH	OTH	unk	unk	unk	~ ()~~~In patient	0010150960124	1						1	Facial palsy	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0092418	11/26/1996	KY				U	11/18/1996	4 pt recv vax & devel bell's palsy;									U				NONE REPORTED	OTH	OTH	unk	unk	unk	~ ()~~~In patient	0010150960123	1						1	Facial palsy	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0092421	11/26/1996	MA	28.0	28		F	11/18/1996	abd hives, pruritus, dizziness;given DPH;									Y	11/14/1996	11/14/1996	0	NONE	OTH	PUB	NONE	abd hives, dizziness	NONE	NONE~ ()~~~In patient		1						1	Dizziness; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71226~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092424	11/26/1996	MN	81.0	81		F	11/21/1996	localized erythema, induration, pruritus from 2 days p/vax to present;5x7 cm;									U	11/13/1996	11/15/1996	2	NONE	PVT	OTH		NONE	allergy inderal, ibuprofen, vibramkin;HTN	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Pruritus	FLU3~CONNAUGHT LABORATORIES~6F71292~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~438670~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~6HB1269~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0092426	11/26/1996	MN	39.0	39		M	11/15/1996	immed p/vax pt could not move fingers but had moderate pain down arm;ice helped;p/1st day thru present;cont to have weakness in lt hand/wrist;									U	10/15/1996	10/15/1996	0	NONE	PUB	PUB		NONE	unk	~ ()~~~In patient	MN96045	1						1	Myasthenic syndrome; Pain	FLU3~CONNAUGHT LABORATORIES~6968163~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092427	11/26/1996	CA	54.0	54		F	11/18/1996	minor constriction in chest (but definitely  noticeable);10-20min p/vax;same evening required motrin & ice packs for soreness & onset of swelling;also very itchy;swelling hot, hard, sore , itchy moved from deltoid inj site to inner bicep;									Y	10/25/1996	10/25/1996	0	NONE	OTH	OTH	Normodyne, Premarin, Paxil	NONE	allergic to sulfur & all sulfur derivatives, thimerosol several antihypertension meds;	pt exp same rxn entire life w/tetanus all doses;~ ()~~~In patient		1						1	Chest pain; Injection site mass; Injection site oedema; Injection site pain; Oedema; Pain; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71214~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092428	11/26/1996	MA	71.0	71		F	11/19/1996	still coughing;				Y					N	10/17/1996	10/20/1996	3	NONE	PUB	OTH	prempro, vitamin, alendronate	osteoporosis study		NONE~ ()~~~In patient		1						1	Cough	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0092435	11/26/1996	WI	42.0	42		F	11/20/1996	5 reddened area;									Y	11/05/1996	11/05/1996	0		PVT	PVT	NONE	NONE		~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~4968181~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092442	11/26/1996	OH	11.0	11		M	11/12/1996	9NOV96 lt arm became red & swollen about 4 diameter;pt felt nauseated w/ h/a, t102;APAP given;10NOV96 sl h/a, sensitive to light, t104, lt arm remained red, swollen, painful;went to hosp ER;				Y					Y	11/08/1996	11/09/1996	1	CXR negative, lymph glands negative;elevated WBC count;	PUB	PVT	NONE	NONE	pneumonia JAN96, encephalitis complication of chicken pox	~ ()~~~In patient	OH96145	1						1	Headache; Injection site hypersensitivity; Injection site oedema; Injection site pain; Leukocytosis; Nausea; Photophobia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71308~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~390934~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0091501	11/27/1996	PA	41.0	41		F	11/27/1996	same noc of vax pt exp pain in arm & had trouble sleeping;arm became very red & swollen;red & large as baseball;pt did not move arm much because of pain;call MD;2 days later throbbing pain in arm;frozen in place;hot to touch;skin discolored									Y	10/04/1996	10/04/1996	0		PVT	PVT	Synthroid, PRemarin			~ ()~~~In patient		1						2	Injection site hypersensitivity; Injection site inflammation; Injection site mass; Injection site oedema; Injection site pain; Arthralgia; Hypokinesia; Insomnia; Oedema; Pain; Skin discolouration; Vasodilatation	FLU3~PARKE-DAVIS~01286P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~01286P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~PFIZER\WYETH~436122~1~~RA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0092445	11/27/1996	TX	57.0	57		F	11/21/1996	29OCT96 shoulder stiff;30OCT lt rib sore;31OCT tingling rt fingers;3NOV add fatigue & muscle weakness;5NOV swollen foot;t100 6NOV;7NOV appt w/MD muscle so weak can barely walk, hands, knees & feet swollen;to MD 13NOV96;trouble walking,sit;									N	10/21/1996	10/29/1996	8	15NOV96 lab tests done showed nothing except anemia;white count low-sed rrate inflamed;	PVT	OTH	NONE	NONE	NONE	pt son exp serve illness 22OCT96 @ 28yr old w/flu vax;~ ()~~~In patient		1						1	Antinuclear antibody; Hypertonia; Hypokinesia; Laboratory test abnormal; Paraesthesia; Pyrexia; Red blood cell sedimentation rate increased; Systemic lupus erythematosus	FLU3~PARKE-DAVIS~01286P~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0092446	11/27/1996	NE	33.0	33		F	11/18/1996	flashing spot in lt eye visual field, h/a;change in acuity;inc sleeping;				Y					Y	10/30/1996	11/02/1996	3	CBC, 22, ESR, T7, B12, Folate, RPR, ANA, CT head, CSF panel, VDRL CSF-all nl;	OTH	OTH				~ ()~~~In patient		1						1	Headache; Somnolence; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0092449	11/27/1996	LA	49.0	49		F	10/28/1996	19OCT area of inj indurated & reddened w/severe itching noted;area was approx 10cm diameter;24OCT noted mild flu like s/s, achiness, soreness, lethargy lasting 1 day;DPH allergy taken;relieved itching & discomfort;lt arm skin rash, flu synd										10/18/1996	10/19/1996	1	NONE	UNK	UNK			have had allergic skin rxn to cipor, tetrax in past;skin rxn have been severe;	~ ()~~~In patient		1						1	Influenza; Injection site hypersensitivity; Injection site mass; Myalgia; Pruritus; Rash; Somnolence	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092451	11/27/1996	OK	42.0	42		M	11/26/1996	cyanosis, shallow resp, diminished, heart sounds;taken by EMS to hosp;tx w/epi;				Y					Y	10/18/1996	10/18/1996	0		OTH	OTH				~ ()~~~In patient		1						1	Cardiac failure; Cyanosis; Hypoventilation	FLUX~UNKNOWN MANUFACTURER~4968163~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0092453	11/27/1996	MI	62.0	62		F	11/12/1996	rt arm became very sore, red, hot, edematous from inj site to elbow to chest;began around 5PM 7NOV96;soreness gone by 4PM 8NOV96;swelling gone by 12NOV96;did not seek medical tx;									Y	11/07/1996	11/07/1996	0		OTH	PUB		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia; Oedema; Vasodilatation	FLU3~PARKE-DAVIS~00276P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~0845D~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0092463	11/29/1996	AZ	95.0	95		M	11/01/1996	1 of 2 pt from long-term care facility, out of 50 vaccinees, to die (of unspecified causes & p/an unspecified interval) following flu vax;	Y	10/31/1996							N	10/27/1996	10/31/1996	4		OTH	OTH	unk	unk	HTN, dementia, seizure disorder, and prostate cancer		896309011L	1						1	Apnoea; Cardiac failure; Diarrhoea; Electrolyte imbalance; Hypoxia; Syncope; Vomiting; Confusional state; Somnolence; Speech disorder; Stupor	FLU3~PFIZER\WYETH~4968162~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968162~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Results in Death	Influenza
0092464	11/29/1996	AZ	91.0	91		F	11/01/1996	1 of 2 pt from a long-term care facility, out of 50 vaccinees, to die (of unspecified causes & p/an unspecified interval) following receipt of flu vax;	Y	10/31/1996							N	10/23/1996	10/30/1996	7		OTH	OTH	unk	unk	TYPE II DIABETES, CHF,SCHIZOPHRENIA, UTI		896309012L	1						1	Dyspnoea; Peripheral vascular disorder; Pupillary disorder; Speech disorder; Syncope; Stupor	FLU3~PFIZER\WYETH~4968162~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968162~1~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Results in Death	Influenza
0092465	11/29/1996	WY	44.0	44		M	11/25/1996	numbness & tingling in feet 10NOV96;progressed into fingers 11NOV96 & 12NOV96;diff walking 13NOV96;inc diff walking  w/weakness that was also noted in the arms 18NOV96;			Y	Y	Y	4			N	10/29/1996	11/10/1996	12	refer to primary MD while in hosp;	OTH	PUB	NONE	NONE	PCN allergy	~ ()~~~In patient		1						1	Gait disturbance; Hypokinesia; Myasthenic syndrome; Neuritis; Neuropathy; Paraesthesia	FLU3~PFIZER\WYETH~4968162~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0092468	11/29/1996	TX	35.0	35		F	11/19/1996	muscle aches, cough, sore throat, h/a, fatigue, fever 100, sx began on 8NOV96 have cont 19NOV96, also back pain;pain in inj site & entire rt arm;saw MD who states pt had a virus;									U	11/08/1996	11/08/1996	0	NA	PUB	PUB	Tegretol;Paxil	NA	allergies:dust mites/mt cedar;neuro;sz disorder	pt exp anaphalactic rxn @ 34yr old w/allerby shot;~ ()~~~In patient	SA96013	1						1	Asthenia; Back pain; Cough; Headache; Injection site pain; Myalgia; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71275~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092471	11/29/1996	NH	39.0	39		M	11/15/1996	pt fainted x 2, 5min p/vax;amb called but pt refused to to to ER MD called;				Y					Y	11/13/1996	11/13/1996	0	NONE	OTH	OTH	NONE	unk		NONE~ ()~~~In patient	NH96031	1						1	Syncope	FLU3~MEDEVA PHARMA, LTD.~E3046GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0092472	11/29/1996	MA	42.0	42		M	11/21/1996	10min p/vax hives noted on vaccinated arm;DPH given & resolved w/in 30min;									Y	11/19/1996	11/19/1996	0	NONE	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Urticaria	FLU3~PFIZER\WYETH~4968209~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092473	11/29/1996	OH	70.0	69		M	11/13/1996	pt recv vax 29OCT96 in lt deltoid;930PM pt had t103, chills, shaking, body aches, weakness that lasted about 3 days;pt did not take APAP or med for the sx;									Y	10/29/1996	10/29/1996	0		PUB	PUB		NA		NA~ ()~~~In patient	OH96150	1						1	Asthenia; Chills; Myalgia; Pyrexia; Tremor	FLU3~CONNAUGHT LABORATORIES~6F71308~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0092478	11/29/1996	MA	78.0	78		F	11/20/1996	pt recv vax & felt severe pain @ inj site;no redness, swelling;lt arm cont to hurt when using arm or raising arm;5/10 on scale of 1-10;Ibuprofen taken w/some relief;									Y	10/09/1996	10/09/1996	0		PUB	PUB	Zestril, Cortisone, Zocor	NONE	Hypertension, high cholesterol, tendonitis, lt blusih's	~ ()~~~In patient	MA9624	1						1	Hypokinesia; Injection site pain; Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~6F71226~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~394963~1~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0092479	11/29/1996	MA	40.0	40		M	11/12/1996	8NOV96 devel fever (did not take temp), felt woozy arm pain @ site of inj;all resolved in 2 days;also devel bilat rash in armpits, rt armpit also swollen & red, lt rash only;lateral pain in armpits R>L;									Y	11/08/1996	11/08/1996	0		OTH	PUB	NONE	NONE	NONE	~ ()~~~In patient	MA9623	1						1	Dizziness; Injection site pain; Lymphadenopathy; Oedema peripheral; Pain; Pyrexia; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71226~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092483	11/29/1996	OK	14.0	14		M	10/31/1996	2 days p/vax devel a gen rough red rash w/extreme itching;resolved p/4th day;									Y	10/23/1996	10/25/1996	2	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	OK9643	1						1	Pruritus; Rash maculo-papular	FLU3~MEDEVA PHARMA, LTD.~E3066GB~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~SMITHKLINE BEECHAM~2007A2~1~IM~LA~HEP B (ENGERIX-B)~1	USA		Influenza
0092484	11/29/1996	OK	68.0	68		M	10/23/1996	pt states woke up 3AM 19OCT96 & notice a numbness & tingling sensation in lt foot;states noticed the sensation moving into ankle, knee hip, arm & lt side of neck x 3 days;has residual pain w/soreness & tenderness in lt hip;diff getting up				Y					Y	10/18/1996	10/19/1996	1		PUB	PUB	NONE	NONE	polio on lt side @ age 3yr old;	NA~ ()~~~In patient	OK9642	1						1	Hypokinesia; Myalgia; Pain; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~E3066GB~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0092486	11/29/1996	MA	25.0	25		F	11/19/1996	swollen joints-hands & all major joints per pt;no joint inflam detected on exam;				Y					U	11/12/1996	11/13/1996	1		OTH	OTH	NONE	NONE	nONE	~ ()~~~In patient		1						1	Oedema peripheral; Osteoarthritis	FLUX~UNKNOWN MANUFACTURER~~5~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0092487	11/29/1996	IL	65.0	65		F	11/12/1996	pt recv vax 23OCT96 930AM;devel itching on way out to car p/flu vax;2 hr later eyes were swollen, flushed & h/a & itched on face & shoulders;itching eyes for 3 days, other sx lasted throughout the afternoon of 23OCT96;pt took DPH									Y	10/23/1996	10/23/1996	0		PUB	PUB	NOrvasc	NONE	HTN, fibromyalgia	~ ()~~~In patient	IL960111	1						1	Face oedema; Headache; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71272~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092488	11/29/1996	IL	56.0	56		F	11/18/1996	swelling rt arm immed p/vax;nurse gave DPH p/3hr;tremendous pressure redness & swelling down to elbow-around back to shoulder blade;saw MD 6NOV prescribed ATB & Vicodin x 10 days;still has some pain;most of redness & swelling gone;									Y	11/05/1996	11/05/1996	0		PUB	PUB	unk	NONE	asthma	NONE~ ()~~~In patient	IL960112	1						1	Oedema peripheral; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~671246~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~432690~1~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0092490	11/29/1996	CO	38.0	38		F	11/25/1996	severe muscular & joint pain & incapacitating fatigue;any movements caused pain;dec ROM hips & shoulders;									N	10/16/1996	10/29/1996	13	nl-CBC, ESR, CPR, BIOCHEM, ANA, RA factor & ASO titre;	PVT	PVT	NONE	NONE	has had neck pain from MVA 1990 off & on;	~ ()~~~In patient		1						1	Arthralgia; Asthenia; Hypokinesia; Movement disorder; Myalgia; Pain; Arthralgia; Asthenia; Back pain; Condition aggravated; Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~6H81269~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71213~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0092494	12/02/1996	CO	67.0	67		M	10/30/1996	numbness beginning on lt side-fingers arm-spread to rt side then both feet up to & above hips;					Y	3			U	10/11/1996	10/22/1996	11	X-rays, Spinal tap lab including heavy metals/toxins;	PUB	OTH		NONE	NONE	~ ()~~~In patient	CO96057	1						1	Hypokinesia; Neuropathy; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4968165~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~5L71095~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0092495	12/02/1996	CA	63.0	63		M	11/26/1996	exp clear rhinorrhea for a couple of days; 20NOV noted tingling in fingers;over next 3 days devel weakness in upper & lower extremities, symmetric & ascending;23NOV pt seen @ hosp afeb, but very weak;adm ICU, unable to walk;dx GBS;			Y		Y				N	11/04/1996	11/20/1996	16		PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome; Hypokinesia; Hypotonia; Myasthenic syndrome; Paraesthesia; Rhinitis	FLU3~PFIZER\WYETH~4968137~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0092496	12/02/1996	CA	58.0	58		M	11/26/1996	pt w/man pre-existing problems recv vax 18OCT96 & exp stuffy nose x a day or tow;1NOV exp bilat sensory loss in feet & hands;2 days later felt too weak to walk;seen 6NOV & adm to hosp;still unable to walk;dx GBS;			Y		Y				N	10/18/1996	11/01/1996	14		PUB	PUB	ASA, NPH & regular Insulin	used to walk 7miles everyday a/GBS	degenerative arthritis;insulin dependent diabetes	NONE~ ()~~~In patient	CA960149	1						1	Asthenia; Guillain-Barre syndrome; Hypokinesia; Hypotonia; Myasthenic syndrome; Paraesthesia; Rhinitis; Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~6F71234~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71234~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0092497	12/02/1996	AZ	67.0	67		M	11/26/1996	pt recv vax 21OCT96 & 15NOV noted changes in sensations in hands & dec strength in upper extremities, dec sensation in tongue & lips & dec strength in facial muscles;transferred to another hosp in ICU w/weakness & sensory changes;dx G			Y		Y				N	10/21/1996	11/15/1996	25		PUB	PUB	ASA	Paraplegia	T6 paraplegia; s/p kidney tumor;	NONE~ ()~~~In patient	AZ9716	1						1	Asthenia; Guillain-Barre syndrome; Hypotonia; Myasthenic syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~6F71230~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0092499	12/02/1996	VA	43.0	43		F	11/19/1996	2 days p/vax lt chest pain-pleuresy-lupus exacerbation??;				Y	Y	2			Y	10/01/1996	10/03/1996	2		MIL	PVT	Procardia, Hydrochlorthiazide, Clonidin, Inderal	HTN	NA	~ ()~~~In patient		1						1	Chest pain; Pleural disorder; Systemic lupus erythematosus	FLU3~PFIZER\WYETH~4968182~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0092511	12/02/1996	MD	49.0	49		F	10/28/1996	24OCT96 began w/swollen, red, inflamed, welt & heat;had diarrhea, loss of appetite, no vomiting, no h/a, no body aches;(admits to other family members being ill);Friday 25OCT96 recovered completely;									Y	10/23/1996	10/24/1996	1	NONE	PUB	PUB	NONE	NONE but exposed to others w/intestinal upset	NONE	~ ()~~~In patient	MD96045	1						1	Anorexia; Diarrhoea; Oedema peripheral; Urticaria; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E2986FA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0092513	12/02/1996	NJ	54.0	53		F		pt recv vax & devel hard swelling/lump x 1wk @ site of pneumonia shot;reporter states both shots were administered one right p/the other, 1 in each arm;				Y					Y	01/30/1996	09/30/1996	244		PUB	PUB		multiple chemical sensitiivty, reactive airway disease, etc	allergies to chemicals & ATB, etc	~ ()~~~In patient	NJ9630	1						1	Oedema peripheral; Skin nodule	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0092514	12/02/1996	CA	80.0	80		U	10/24/1996	sore arm;poss cellulitis vs vaccine reaction;				Y					U	10/07/1996	10/11/1996	4		PUB	PUB	NONE	not declared-NONE		~ ()~~~In patient	CA960115	1						1	Cellulitis; Myalgia	FLU3~CONNAUGHT LABORATORIES~6F71212~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1391B~UNK~SC~~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~6981015~UNK~IM A~~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0092518	12/02/1996	CA	77.0	77		M	10/31/1996	pt recv vax 15OCT96 & approx 3-4 days p/vax began to develop achiness in muscles & all over body;16 days p/vax still has achiness & stiffness & some pain in buttocks when sits;pt will see PMD 1NOV96;									U	10/15/1996	10/18/1996	3	no lab tests done yet r/t vax;	PUB	PUB		NONE	Idiopathic sensory neuritis	NA~ ()~~~In patient	CA960114	1						1	Hypertonia; Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~6F71212~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092524	12/02/1996	CO	24.0	24		F	10/28/1996	pt recv vax  & felt like had a bite on lt arm where shot was given;pea sized sl below site was painful & red;felt like itching it;called ER @ local hosp;pt massaged site & took warm shower;pt seen 27OCT96 330PM & appeared nl;									Y	10/07/1996	10/26/1996	19	NA	PUB	PVT	Birth control	NONE	NA	~ ()~~~In patient	CO96050	1						1	Injection site mass; Injection site pain; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4968161~5~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092525	12/02/1996	CO				F	10/29/1996	subauricular & axillary lymphadenopathy, fever, redness, swelling @ inj site, diarrhea;				Y					Y	10/22/1996	10/24/1996	2	NA	PUB	PVT	NONE known	not known	NONE known	NA~ ()~~~In patient	CO96051	1						1	Diarrhoea; Injection site hypersensitivity; Injection site oedema; Lymphadenopathy; Pyrexia	FLU3~PFIZER\WYETH~4968161~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092527	12/02/1996	CO	40.0	40		F	11/12/1996	pt reported pain in lt shoulder, aching & dec movement on 8NOV96;stated the inj was given into the joint;advised to see PMD;13NOV6 950AM pt reports aching in arm immed p/vax;seen by MD for pain limited movement of lt arm;				Y					U	10/24/1996	10/24/1996	0	NONE	PUB	PUB		NONE		~ ()~~~In patient	CO96053	1						1	Hypokinesia; Myalgia; Pain	FLU3~PFIZER\WYETH~4968164~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092528	12/02/1996	CO	51.0	51		F	10/25/1996	rt deltoid area very red, swollen w/pt c/o itchy feeling on observation several long raised white areas noted around inj site (? secondary to itching);				Y					Y	10/25/1996	10/25/1996	0		PUB	PUB		none	none	none~ ()~~~In patient	CO96054	1						1	Injection site hypersensitivity; Injection site mass; Oedema peripheral; Pruritus; Skin discolouration; Vasodilatation	FLU3~PFIZER\WYETH~4968165~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092529	12/02/1996	CO	33.0	33		M	10/25/1996	15 p/vax pt devel tingling in fingers & rt hand * then numbness throughout rt hand & arm up to deltoid/shoulder area;				Y					Y	10/25/1996	10/25/1996	0		PUB	PUB		NONE	NONE	~ ()~~~In patient	CO96055	1						1	Paraesthesia	FLU3~PFIZER\WYETH~4968165~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092530	12/02/1996	MS	54.0	53		F	11/20/1996	pt recv vax & noted the arm to be sl swollen, skin warm w/erythema noted;axilla area-swollen lymph nodes w/pain to touch;rxn occurred 2-3 hr p/inj;tx warm compresses to site or hot tub w/water & DPH;				Y					U	11/19/1996	11/19/1996	0		PUB	OTH	unk	NONE		~ ()~~~In patient	MS96049	1						1	Lymphadenopathy; Oedema peripheral; Pain; Rash; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E30866F~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~436824~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0092539	12/02/1996	MT	70.0	70		F	11/18/1996	severe stiff neck & pain by 11NOV96 inability to move head to either side or to elevate chin, spot posterior to lt ear & @ base of head;sore as a boil & pain extending to inside lt ear, low grade fever;also pain lt arm-no inj site pai									Y	11/07/1996	11/09/1996	2	NA	PUB	UNK	Levoxyl	NONE	NONE	NONE~ ()~~~In patient		1						1	Ear pain; Headache; Hypokinesia; Neck pain; Nuchal rigidity; Pyrexia	FLU3~PFIZER\WYETH~4968206~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092540	12/02/1996	MD	29.0	29		F	11/25/1996	pt recv vax SC on posterior arm 5inches above the elbow;area around inj site approx 4inches in diameter became red, warm, swollen & painful;had low grade fever (100.0 - 100.4) & h/a for 10 days p/vax;25NOV discolored around inj site									Y	10/30/1996	10/30/1996	0		PUB	UNK	BCP, Synthroid, Plaquernil, Omepnazole, Elavil	NONE	undifferential connective tissue disease, thyroiditis, gastroparesis, polycystic ovaries;	~ ()~~~In patient		1						1	Headache; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia; Skin discolouration; Vasodilatation	FLU3~PFIZER\WYETH~4968136~2~SC A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092542	12/02/1996	MA	31.0	31		F	11/21/1996	pt recv vax 18NOV96 & site of inj rt deltoid immed became red w/ 1/2 area of swelling;area was red & site cont to swell over next few hr;arm painful & swelling to axilla area;									Y	11/18/1996	11/18/1996	0	NONE	PUB	UNK		NONE		~ ()~~~In patient	MA9625	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Pain	FLU3~CONNAUGHT LABORATORIES~6F71226~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0001D~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0092544	12/02/1996	VA	45.0	45		F	11/26/1996	urticaria, chest pain, SOB, voice changes w/in 3hr of vax;pt came to ER p/vax;				Y					Y	10/05/1996	10/05/1996	0		UNK	UNK	NONE			~ ()~~~In patient		1						1	Chest pain; Dysphonia; Dyspnoea; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0092549	12/02/1996	AR	7.0	7		F	11/21/1996	5min p/vax c/o light headed, h/a, ears & eye pain resolved completely p/10 min;									Y	11/21/1996	11/21/1996	0	NA	PVT	PVT	NA	NA	NA	pt sibling exp light-headed, h/a, pain ear & eye @ age 10 w/flu dose 2-3;~ ()~~~In Sibling		1						1	Dizziness; Ear pain; Eye pain; Headache	FLU3~CONNAUGHT LABORATORIES~6F71288~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092550	12/02/1996	AR	10.0	10		M	11/21/1996	10min p/vax cool, clammy, nausea, side pain, light headed, h/a, BP 100/70;sx completely gone p/10 min of monitor;									Y	11/21/1996	11/21/1996	0	NA	PVT	PVT	NA	NA	NA	pt sibling exp cool, clammy, nausea, side pain, ligh headed, ha/ BP 100/70~ ()~~~In Sibling		1						1	Chills; Dizziness; Headache; Hyperhidrosis; Hypotension; Nausea	FLU3~CONNAUGHT LABORATORIES~6F71288~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092554	12/02/1996	WI	49.0	49		F	11/22/1996	30min p/vax pt very warm-very red face & neck w/hive like areas;no diff breathing or swallowing;BP 200/80-heart rate 84, resp 24;face appeared puffy;sent to ER tx w/med;exp sensitivity to cold w/hands swelling up;				Y					Y	11/10/1996	11/10/1996	0	NONE	OTH	PVT	plain robitussin	dry, hacky cough gets every winter	amoxicillin allergy;hayfever, high cholesterol	pt exp nausea & gen malaise p/1995-1996 flu vax;~ ()~~~In patient		1						1	Face oedema; Hypertension; Hyperventilation; Oedema peripheral; Paraesthesia; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4968156~2~A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092555	12/02/1996	OH	50.0	50		M	10/22/1996	hearing deficit;labyrinthitis				Y					U	10/18/1996	10/20/1996	2		PUB	OTH	NONE			~ ()~~~In patient		1						1	Deafness; Vestibular disorder	FLU3~PFIZER\WYETH~4968183~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092504	12/03/1996	PA				U	11/20/1996	pt devel aplastic anemia about 1mo p/vax;this case was reported by a pharmacist;			Y						U				NOT SPECIFIED	OTH	OTH	NOT SPECIFIED	NOT SPECIFIED	NOT SPECIFIED	~ ()~~~In patient	0010150960128	1						1	Aplastic anaemia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0092505	12/03/1996	NJ	82.0	82		F	11/22/1996	pt recv vax 22OCT96 & 29OCT96 exp n/v, vomiting blood, & diarrhea w/o fever;pt hosp & condition has been described as grave;pt has not yet recovered;	Y	11/17/1996			Y	19			N	10/22/1996	10/29/1996	7	emesis positive for occult blood	OTH	OTH	Theophylline, Lanoxin, Lasix, Multiple vitamins, Synthroid, Maalox, Prevacid, Compazine, Propulsid, Capoten, Potassium, Lactulose;	unk	peptic ulcer disease, COPD, atrial fibrillation, hypothyroidism, pacemaker, mitral valve replacement;	~ ()~~~In patient	0010150960057	1						1	Abdominal distension; Abdominal pain; Diarrhoea; Haematemesis; Nausea; Vomiting	FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0092506	12/03/1996	CA	74.0	74		M	10/29/1996	pt recv vax 22OCT96 12PM;6PM pt was vomiting & pain in lt upper abd;12MN pain worst-MD met pt @ ER pt had abn EKG, elevated WBC, elevated BP, CXR abn;				Y	Y				U	10/22/1996	10/22/1996	0	EKG, CXR, elevated BP, WBC	PUB	PUB	Lupron	denies		~ ()~~~In patient	CA960120	1						1	Abdominal pain; Electrocardiogram abnormal; Hypertension; Leukocytosis; Lung disorder; Vomiting; Abdominal pain; Electrocardiogram abnormal; Hypertension; Leukocytosis; Lung disorder; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71213~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71213~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0092507	12/03/1996	MI	39.0	39		F	11/22/1996	pt felt flushed & warm;by evening pt feet were cold like had bad circulation & devel numbness & tingling & felt like was walking on pins;also devel weakness 19OCT96;22OCT96 exp fluttering in abd;exp memory loss, neuro c/o weakness, fatigue				Y				Y	N	10/18/1996	10/18/1996	0	NONE	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	0010150960040	1						1	Amnesia; Asthenia; Myasthenic syndrome; Neuropathy; Paraesthesia; Peripheral vascular disorder; Pyrexia; Vasodilatation	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Disabling	Influenza
0092508	12/03/1996	VA	67.0			F	11/18/1996	GBS secondary to flu vax;					Y			Y			11/03/1996		MRI scan nl;spinal tap nl;S&T spine;	UNK	UNK			NONE	~ ()~~~In patient		1						1	Guillain-Barre syndrome; Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation,Disabling	Influenza
0092560	12/03/1996	UT	53.0	52		F	10/09/1996	immed following vax pt felt pins & needles on anterior forearm & hand;also felt pins & needles in lt anterior thigh, calf, foot & lt side of jaw;8hr later arm swelled & was hot to touch;224hr p/vax had a 15cm x 10cm raised welt about									Y	10/08/1996	10/08/1996	0	NONE	PUB	PUB			probable MS or possible myasthenia gravis	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Oedema peripheral; Paraesthesia; Vasodilatation	FLU3~PFIZER\WYETH~4968161~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1627B~1~SC L~~PNEUMO (PNEUMOVAX)~1|TTOX~CONNAUGHT LABORATORIES~6F81202~UNK~IM~RA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0092562	12/03/1996	WA	53.0	53		F	11/25/1996	pt recv vax 31OCT96;w/in 10min pt devel red warm area below site of inj followed by overall itching w/o rash;c/o aching in lt arm shoulder & neck;numbness in lt hand;given DPH;									Y	10/31/1996	10/31/1996	0		PVT	PVT	Estrogens, Prilosec, Vit B50	NONE	cat dander, hay, certain dyes;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Myalgia; Paraesthesia; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4968162~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092564	12/03/1996	OR	73.0	73		F	11/25/1996	onset gen persistent myalgias 3 days p/vax 29OCT; pain inc w/activity;no weakness or numbness;no muscle tenderness;nl CPK;									N	10/24/1996	10/27/1996	3	NA	PVT	PVT	Sinenet, Klonopin, Zantace, Feldane, Premarin, Provera, Thyroid	NA	restless leg synd, hypothyroidism;	NA~ ()~~~In patient		1						1	Hypokinesia; Myalgia; Pain	FLU3~PFIZER\WYETH~4968177~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092572	12/03/1996	CA	40.0	40		F	10/31/1996	h/a, droopy rt eye lid, body aches, nausea, chills;expect sx resolution over next 24 hr;				Y						10/29/1996	10/30/1996	1		OTH	PVT	allegra;Nazocort	NONE	hayfever, food allergies	NONE~ ()~~~In patient		1						1	Chills; Eye disorder; Headache; Myalgia; Nausea	FLU3~CONNAUGHT LABORATORIES~6F71227~UNK~SC A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0092577	12/03/1996	CA	60.0	60		F	10/18/1996	c/o painful swelling w/large nodule @ inj site;area was hot to touch & arm hurt;also felt feverish, temp not taken & achy;									Y	10/14/1996	10/15/1996	1	NONE	PUB	PUB	Premarin	NONE	NONE	~ ()~~~In patient	CA960121	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Myalgia; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71212~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~6F81202~2~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0092578	12/03/1996	CA	61.0	61		F	10/28/1996	48hr p/vax pt came down w/shingles;pt suspects there might be some connection but of course it's only a theory;it's a fairly light case;took med;				Y					Y	10/10/1996	10/12/1996	2	didn't need tests-rash was obvious;	PVT	PUB	Estrogen, BP cozar, Inderal, Ogen, Naprosyn	NONE	NONE	NONE~ ()~~~In patient	CA960119	1						1	Herpes zoster	FLU3~CONNAUGHT LABORATORIES~6F71212~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0092579	12/03/1996	CA	74.0	74		F	10/23/1996	pt recv vax 15OCT96 to rt deltoid;came to clinic 17OCT96 w/ c/o redness & warmth to rt forearm progressive x 1 days;dx w/cellulitis rt forearm;rx ATB; rechecked 18OCT96, dx w/resolving cellulitis & told to f/u PRN;				Y					Y	10/15/1996	10/16/1996	1	NA	PUB	PUB	calcium carbonate, vit D-zocor;ASA;xanax PRN	unk	NONE	NA~ ()~~~In patient	CA960118	1						1	Cellulitis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71212~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0092581	12/03/1996	OH	90.0	90		F		pt recv vax 4OCT96 & had lt arm pain following it which attributed to vaccine then devel pain in rt arm  & hips; ESR found to be inc from baseline 26 to 59;had resolution of all pains & accompanying malaise w/in 24hr;										10/04/1996	10/04/1996	0	Corticosteroid inj; ESR found to be increased from baseline 26 to 59	UNK	UNK	Synthroid, Pilocarpine, Timoptic, Aldactazide;			~ ()~~~In patient		1						1	Arthralgia; Malaise; Myalgia; Pain; Red blood cell sedimentation rate increased; Malaise; Myalgia; Pain; Red blood cell sedimentation rate increased; Arthralgia; Hypokinesia; Malaise; Myalgia	FLU3~MEDEVA PHARMA, LTD.~E30366A~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~E30366A~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLU3~MEDEVA PHARMA, LTD.~E3036GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~3	USA		Influenza
0092582	12/03/1996	MO	60.0			F		pt recv flu vax & devel asthma-type condition dx extrinisic asthma caused by dust;														UNK	UNK			allergy to some cats, brazil nuts, pollen or ragweed;	~ ()~~~In patient		1						1	Asthma	FLUX~UNKNOWN MANUFACTURER~~3~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0092583	12/03/1996	HI	72.0			M		bronchospasm, low BP, anxeity;				Y						09/19/1996				UNK	UNK	Lasix, Captopril, Tagamet chronic basis;		NKA	~ ()~~~In patient		1						1	Anxiety; Asthma; Hypotension	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0092585	12/03/1996	OK	42.0			M	11/26/1996	reporter stated that p/vax pt exp psynosis, shallow resp & deminished heartsound via stethoscope;taken to ER tx w/epi;pt recovered;				Y					Y	10/18/1996	10/18/1996	0	NONE	UNK	UNK	NONE		NONE	~ ()~~~In patient		1						1	Bradycardia; Cyanosis; Hypoventilation; Bradycardia; Cyanosis; Hypoventilation	FLUX~UNKNOWN MANUFACTURER~4968163~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4968163~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0092586	12/03/1996	CA	57.0			F	11/26/1996	reporter stated that 3 days p/vax rt deltoid became weak & w/in 1wk abscess on rt axilla;MD feels that this was secondary to bacteremia introduced by the flu shot;pt was treated w/ATB & doing fine;										09/19/1996	09/19/1996	0	blood cult-negative;increased WBC	UNK	UNK	ASA		healthy;no hx of illness & no known additions or allergies;	~ ()~~~In patient		1						1	Abscess; Infection; Leukocytosis; Myasthenic syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0092593	12/04/1996	OH	38.0	38		F	11/15/1996	pt recv vax & devel chin & upper lip numbness, lt eye twitch & blurry vision on 25OCT96;14 days p/vax dx w/Bells palsy 25OCT96;pt has not recovered;				Y					N	10/11/1996	10/25/1996	14	NONE provided	PVT	OTH	unk	NONE	NONE	~ ()~~~In patient	0010150960113	1						1	Amblyopia; Eye disorder; Facial palsy; Muscle twitching; Paraesthesia	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0092594	12/04/1996	OH	48.0	48		M	11/15/1996	pt recv vax devel numbness & pain on the side of face 30OCT96;dx w/Bell's palsy 5NOV96;				Y					Y	10/01/1996	10/30/1996	29	NONE PROVIDED	PVT	OTH	Capozide	NONE	history of HTN	~ ()~~~In patient	0010150950112	1						1	Facial palsy; Pain; Paraesthesia	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0092595	12/04/1996	OH	85.0	84		M	11/15/1996	pt recv vax & devel rt facila weakness 4OCT96, 3 days;went to ER & dx w/Bell's palsy;				Y					Y	10/01/1996	10/05/1996	4	NONE PROVIDED	PVT	OTH	unk	NONE	history: pancreatic insuffiency	~ ()~~~In patient	0010150960111	1						1	Facial palsy; Myasthenic syndrome	FLU3~PARKE-DAVIS~00276P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0092597	12/04/1996	OK	48.0	48		U	11/27/1996	pt recv vax 6NOV96 & stated arm began hurting p/inj;became lightheaded & nausea;face became very red then pale;collar @ neck became very tight;chill;				Y					Y	11/06/1996	11/06/1996	0	Graves Disease	OTH	PVT	Synthroid	Unk	unk	~ ()~~~In patient		1						1	Chills; Dizziness; Injection site hypersensitivity; Laryngospasm; Myalgia; Nausea; Pallor; Vasodilatation	FLU3~PFIZER\WYETH~4968198~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092601	12/05/1996	NY	67.0	67		F	11/18/1996	diff breathing, asthmatic coughing, tearing red eyes, chills;DPH, Pred had nof effect;				Y					Y	11/11/1996	11/11/1996	0		OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Asthma; Chills; Conjunctivitis; Cough; Dyspnoea; Lacrimal disorder	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0092602	12/05/1996	MN	42.0	42		F		pt passed out & was sick to stomach w/in 15min p/shot;BP to come back up at first;told to get DPH;									Y	10/16/1994	10/16/1994	0		OTH	OTH	Synthroid	NONE	thyroid	NONE~ ()~~~In patient		1						1	Dyspepsia; Hypotension; Syncope	FLU3~CONNAUGHT LABORATORIES~3F41114~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092636	12/06/1996	CA	63.0	63		F	11/25/1996	deep aching pain in thighs & legs lasted 1 1/2 days;									Y	10/17/1996	10/23/1996	6	NONE	PUB	OTH	NONE	NONE	NONE	unk~ ()~~~In patient		1						1	Myalgia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0092640	12/06/1996	IN	36.0	36		F	11/15/1996	pt recv 31OCT96 by that evening noticed redness & swelling & arm felt heavy;states 2NOV96 & measured 3 1/2 inches diameter;saw MD 13NOV96; had 1 3/4cm red & sl swollen area that was soft & non tender;									Y	10/31/1996	10/31/1996	0	NONE	PVT	PUB	no meds	No illness	Cipro, codimol DH, Robutiussin, Ratuss, ASA	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~6F71288~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092641	12/06/1996	IN	58.0	58		F	11/15/1996	pt recv vax 12NOV96 noticed redness that noc;14NOV96 w/ 2cm induration @ site of inj & surrounding redness & edema of 3x9cm;itching; tx w/med;									Y	11/12/1996	11/12/1996	0	NONE	PVT	PUB	Dyazide, hormone replacement therapy		ceclor & topical steroid cream;	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~6F71288~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092642	12/06/1996	TX	25.0	24		F	11/14/1996	constant nause;body aches;fatigue;									Y	10/28/1996	10/28/1996	0		PVT	PVT	Loestrin, Fe, Prozac		hypothyroidism/hashimoto's thyroiditis, dysthymia;allerg PCN	~ ()~~~In patient		1						1	Asthenia; Myalgia; Nausea	FLU3~PFIZER\WYETH~4968161~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092646	12/06/1996	MA	42.0	42		F	11/25/1996	paresthesias in hands, legs, feet, neck, back pain;seen by MD:				Y					U	10/28/1996	10/31/1996	3	ESR n, B12, folate, CBC, chem A,B	PUB	PVT	Synthroid	NONE	goiter	~ ()~~~In patient		1						1	Back pain; Coordination abnormal; Infection; Muscle spasms; Myelitis; Neck pain; Paraesthesia	FLU3~PFIZER\WYETH~4968200~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092042	12/09/1996	ND	19.0	19		F	12/02/1996	severe h/a, hypotension 92/23, tachycardia 140, leucopenia WBC 1.1;pt hosp for sepsis eval & tx include LP given fluid resuscitation in ER;				Y	Y	2			Y	10/16/1996	10/16/1996	0	WBC 1.1 x 103;H/H 14/41.5, plt 133,000; 42L, 3M, 54S, 1E	MIL	MIL	NONE	NONE	NONE	~ ()~~~In patient		1						2	Headache; Hypotension; Laboratory test abnormal; Pyrexia; Sepsis; Shock; Tachycardia; Vomiting; Dehydration; Headache; Hypotension; Leukopenia; Lymphocytosis; Sepsis; Tachycardia; Thrombocytopenia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|TYP~PFIZER\WYETH~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4968264~3~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|HEPA~SMITHKLINE BEECHAM~VHA490A6~1~~~HEP A (HAVRIX)~2|TYP~PFIZER\WYETH~4968090~1~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0092490	12/09/1996	CO	38.0	38		F	12/03/1996	c/o hip pain 1wk p/shot;pain extended to knees by 13NOV; c/o extreme fatigue & muscle & joint pain 18NOV;extreme pain traveled  to wrists, feet, shoulders & back;inc fatigue;unable to work since 19NOV;2DEC dec pain & fatigue;				Y					Y	10/16/1996	10/23/1996	7	CBC, Sed rate, themoid arthritis eval, thyroid, PSH, C=C biochem;HIP/lumbal spine;thoacic, X-rays;	PVT	PVT	Vit B, C E	NONE	allergic to Oxycodone;Hip pain from injury, intermittent neck pain injury	NONE~ ()~~~In patient		1						2	Arthralgia; Asthenia; Hypokinesia; Movement disorder; Myalgia; Pain; Arthralgia; Asthenia; Back pain; Condition aggravated; Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~6H81269~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71213~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0092612	12/09/1996	LA	67.0	67		F	11/13/1996	pt recv vax & devel transverse myelitis, & was hosp, & is a quadriplegic;reporter was notified  of this event as part of litigation proceedings;	Y				Y			Y	N	10/21/1996	10/21/1996	0		PUB	PUB	unk	NONE	hypertension, hyperlipidemia, hypercholesterolemia and smoking 1.5 packs per day for 13 years	~ ()~~~In patient	896323001L	1						1	Apnoea; Cardiac arrest; Hypertension; Myelitis; Paralysis; Quadriplegia	FLU3~PFIZER\WYETH~4968175~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1626B~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Results in Death	Influenza
0092614	12/09/1996	NY	69.0	69		F	12/02/1996	5min p/vax severe indigestion like pains-cont 2hr;5 times for next 2 days-very severe;nothing like that a/shot-nothing last 2wk;pt took med to stop pain-never needed before;			Y						Y	11/15/1996	11/15/1996	0		PUB	OTH	Amitiptynine 10mg;	NONE	mild depression	NONE~ ()~~~In patient		1						1	Abdominal pain; Chest pain; Influenza; Myocardial ischaemia	FLU3~PARKE-DAVIS~01286P~7+~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening	Influenza
0092631	12/09/1996	PA	61.0	61		F	12/04/1996	16 days p/vax pt exp numbness in feet & hands & severe back pain;adm to hosp 25NOV96 & dx w/GBS;discharged to rehab hosp 2DEC96;					Y	7			N	11/01/1996	11/17/1996	16		PUB	PVT				pt very sick 7-8yrs ago w/flu vax;~ ()~~~In patient		1						1	Back pain; Guillain-Barre syndrome; Paraesthesia	FLU3~PFIZER\WYETH~4968265~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0092634	12/09/1996	NY	44.0	44		F	12/03/1996	pt recv vax & got real sick w/fever, couldn't sit w/o falling;had all kind of test;pt hosp;pt states can't hold anything in hand because of the shaking;					Y	90		Y	Y	02/01/1980	03/01/1980	29		PVT	PVT				~ ()~~~In patient		1						1	Hypokinesia; Malaise; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0092654	12/09/1996	GA	53.0	53		M	12/04/1996	15OCT96 viral gastroenteritis;tx w/meds & clear liquid diet;resolved 17OCT96;reoccurred 29OCT96;23OCT96 gait distrubance (problems w/ambulating affecting rt side primarily;tx w/Ibuprofen;										10/02/1996	10/23/1996	21	eval included neurology 28OCT96;orthopedic eval 31OCT96;MRI 5NOV96 & 13NOV96;C-spine 26OCT96;	PUB	PUB	ga96176	NONE	sz disorder, post-traumatic; gastroesophageal reflux;bipolar disease;	~ ()~~~In patient	GA96176	1						1	Condition aggravated; Gait disturbance; Gastroenteritis; Hypokinesia; Infection	FLU3~MEDEVA PHARMA, LTD.~E2996FB~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0092658	12/09/1996	CA	45.0	45		F		pt recv vax 7NOV96 & then had flu like sx;13NOV96 got nausea, vomiting, diarrhea 11NOV, 12NOV epigastric pain;sx resolved approx 18NOV96 p/Pepcid, Flagyl, Vibramycin;									Y	11/07/1996	11/07/1996	0	Amylase 130 (nl 125); Endoscopy-superficial ulceration neg helicobacter pylori;CBC WNL, T bili 1.3, LFT otherwise nl;	PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Abdominal pain; Blood amylase increased; Hyperbilirubinaemia; Influenza; Laboratory test abnormal; Vomiting	FLUX~UNKNOWN MANUFACTURER~6F71320~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0092662	12/09/1996	NC	66.0	66		M	11/13/1996	noted same day of vax p/vax numbness & weakness to rt hand, pain in area of inj;pt notified clinic where vax given on 7NOV & advised to see MD; f/u call 13NOV96 pt states has had 2 physical therapy tx w/o change in condition;				Y					N	11/04/1996	11/04/1996	0		PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	NC96137	1						1	Injection site pain; Myasthenic syndrome; Paraesthesia	FLU3~PARKE-DAVIS~01186P~2~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0092664	12/09/1996	CA	58.0	58		F	12/03/1996	15NOV96 to MD office w/rash, sore throat, itchy ears ;pt given med;22NOV96 rash spread, cough, back psin, tingling in arm, could not feel feet;25NOV95 inc weakness;26NOV96 adm to hosp dx GBS, back pain, dermatitis & poss spinal cord compres				Y	Y					10/18/1996	11/15/1996	28	26NOV95 CSF protein 202;EMG also performed;WBC 19, RBC 93, glucose 90;Lyme serologies negative, CMV no antibodies detected, toxoplasma IgG and IgM nl;	PVT	PVT	Motrin		NONE	~ ()~~~In patient		1						1	Asthenia; Cough; Guillain-Barre syndrome; Hypoaesthesia; Hypokinesia; Laboratory test abnormal; Neuropathy; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~6F71237~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0092669	12/09/1996	MD	66.0	66		U		brachial plexitis;										10/11/1996	10/13/1996	2		PVT	UNK				~ ()~~~In patient		1						1	Neuritis; Neuropathy	FLU3~CONNAUGHT LABORATORIES~6F71255~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092673	12/09/1996	MI	25.0	25		F	11/21/1996	pt recv vax 4PM @ 415PM began itching, coughing & chest feeling tight;face flushed;BP 110/70, 88, R16;pulse ox 98%, P106, peak flow 450 NMT started finished 430PM;BP 100/72, 95, pulse ox 98;450PM BP 104/72, p88, peak flow 430 feeling fine;									Y	10/22/1996	10/22/1996	0	NONE	OTH	OTH	Azmacort, Proventil, Hismanol, Servent, allergy shots	NONE	allergic pollen, mites, dust, molds, cats	~ ()~~~In patient		1						1	Chest pain; Cough; Hypertension; Hypotension; Hypoventilation; Pruritus; Tachycardia; Vasodilatation	FLU3~PFIZER\WYETH~4968163~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092674	12/09/1996	DC	21.0			M	12/03/1996	sudden onset of dry cough, achiness & chils on 1DEC96;inc posterior cervical lymph nodes, t100;									U					PVT	OTH						1						1	Chills; Cough; Lymphadenopathy; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0092676	12/09/1996	NH	30.0	30		F	10/30/1996	local rxn that cleared;pt reports lesions in mouth & diff breathing;pt stated site red & raised the same size as a golf ball;29OCT96 exp swollen itchy tongue w/non blister like bumps on it, very painful;lip & rt eye swollen;allerg rxn;				Y					Y	10/23/1996	10/29/1996	6		OTH	OTH	Ativan & Zoloft	NONE	NONE	NONE~ ()~~~In patient	NH96026	1						1	Dyspnoea; Face oedema; Glossitis; Hypersensitivity; Injection site hypersensitivity; Injection site mass; Mouth ulceration; Pruritus	FLU3~PFIZER\WYETH~4968185~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092681	12/09/1996	MO	32.0	32		F		11AM on 24OCT96 vax given approx 12PM on 24OCT96 returned to staff givening vax c/o lightheadedness & feeling itchy;stated has allergies & can tell when skin is going to break out; no c/o SOB or diff breathing;BP 130/84;skin warm & dry;				Y					Y	10/24/1996	10/24/1996	0		OTH	PVT		NONE	Kimlinger;allergies	~ ()~~~In patient		1						1	Condition aggravated; Dizziness; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4968168~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092686	12/09/1996	CA	58.0	58		F	11/12/1996	general myalgia;multiple joint pain;chills;pt has been taking Ibuprofen for pain;				Y					N	10/07/1996	10/08/1996	1		PVT	OTH		NA	HTN, chronic ETOH abuse	NA~ ()~~~In patient		1						1	Arthralgia; Chills; Myalgia	FLU3~CONNAUGHT LABORATORIES~6F71213~2~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0092697	12/09/1996	CA	72.0	72		F	11/03/1996	pt recv vax 1NOV96 & 2NOV96 arm became very red in area of inj;lip was swollen & had been having stomach cramps;instructed to contact MD;saw MD 5NOV96 & given med;blood work done;				Y					Y	11/01/1996	11/02/1996	1	unk	PUB	PUB	NONE	NONE	pollens	~ ()~~~In patient	GA96158	1						1	Abdominal pain; Face oedema; Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~6F71313~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0092700	12/09/1996	TN	54.0	54		F	10/21/1996	18OCT96 t100, both arm sore, swollen, nauseated & vomiting;19OCT96 330AM t102;took APAP & applied moist heat to lt arm;arm sore;20OCT96 lt arm sore, swollen w/red streaks present;went to ER dx staph cellulitis on ATB;21OCT96 feels better;				Y					U	10/17/1996	10/18/1996	1		PUB	OTH		arthritis	arthritis	~ ()~~~In patient	TN96093	1						1	Cellulitis; Myalgia; Nausea; Oedema peripheral; Pyrexia; Skin striae; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71288~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~431804~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0092705	12/09/1996	NV	50.0	50		M	10/15/1996	pt rt arm hurt & was painful immed p/vax;pain in rt shoulder, neck & rt arm;pt states felt like a pinched nerve;broke out w/mac pap rash;c/o coldness axilla to fingers of rt arm was cold to touch, color change blanching, sl numbness;				Y					N	10/08/1996	10/09/1996	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	NV96031	1						1	Dermatitis bullous; Myalgia; Neck pain; Pain; Paraesthesia; Rash maculo-papular; Skin discolouration	FLU3~PARKE-DAVIS~01286P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0092707	12/09/1996	WA	54.0	53		F	10/31/1996	pt described itching @ area of inj on lt deltoid then turned red & became edematous approx 3 diameter;p/several min itching & redness subsided, swelling dec w/in 45min;pt states feels a little lightheaded but nothing else;									Y	10/31/1996	10/31/1996	0		OTH	PVT		NONE		~ ()~~~In patient	WA961295	1						1	Dizziness; Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PARKE-DAVIS~00886P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0092714	12/09/1996	WA	47.0	46		F	11/21/1996	pt recv vax 28OCT;pain assoct w/flu shot has progressively worsened to shoulder aching & pain;some relief w/heat & Ibuprofen;				Y					N	10/28/1996	10/28/1996	0		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	WA961309	1						1	Myalgia; Pain	FLU3~PFIZER\WYETH~4968203~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092715	12/09/1996	WA	7.0	7		M	10/31/1996	seen @ hosp onset earche 26OCT dx Bell's palsy;28OCT to MD for confirmation dx- progressive rt side weakness droopy, rt lip, unable to close;				Y					Y	10/25/1996	10/26/1996	1		PVT	PVT		NONE	NONE	NONE~ ()~~~In patient	WA961307	1						1	Ear pain; Facial palsy	FLU3~CONNAUGHT LABORATORIES~6F71246~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0092717	12/10/1996	OH	53.0	53		M	11/27/1996	fever, tired, aches, h/a, runny nose, t102-103 lasted 5 days;									Y	11/08/1996	11/15/1996	7		PUB	PUB		cold		~ ()~~~In patient	OH97034	1						1	Asthenia; Headache; Myalgia; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~6F71308~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092721	12/10/1996	MA	1.1	1	.1	F	12/03/1996	febrile seizure 24hr p/vax;				Y					Y	12/02/1996	12/03/1996	1		PVT	PUB	NONE	body rash, no fever		~ ()~~~In patient		1						1	Febrile convulsion	FLU3~CONNAUGHT LABORATORIES~6F71226~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0092722	12/10/1996	MA	31.0	31		F	12/03/1996	watery, itchy, red eyes, coughing, SOB;									Y	11/14/1996	11/14/1996	0	NONE	OTH	OTH	NONE	NONE	animals-dogs/cats	~ ()~~~In patient		1						1	Conjunctivitis; Cough; Dyspnoea; Lacrimal disorder; Pruritus	FLU3~CONNAUGHT LABORATORIES~6F71226~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092727	12/10/1996	CA	70.0	70		F	12/04/1996	broke out w/herpes w/in hr p/vax;flu shot-leg vesicles on lt side of face involving trigeminal nerve covering entire side lt of face & ear;severe pain in entire area of face & neck;(inj given lt arm)-signs of inflammation;tx w/med;high temp				Y					U	10/15/1996	10/15/1996	0	NONE	PVT	OTH	Pamoxiphene, Thyroid, Inderal, Vitamins	NONE	NONE	NONE~ ()~~~In patient		1						1	Dermatitis bullous; Herpes zoster; Infection; Neck pain; Neuralgia; Pain; Pyrexia	FLU3~PFIZER\WYETH~4968146~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092728	12/10/1996	VA	51.0	51		M	12/07/1996	swelling of lower lip & hard sore spot lasting from 21NOV to 27NOV;									Y	11/15/1996	11/21/1996	6	condition simply disappeared by 27NOV96;	PVT	PVT		NONE	nONE	NONE~ ()~~~In patient		1						1	Face oedema; Pain; Skin nodule	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0092730	12/10/1996	CA	49.0	49		F	11/29/1996	fluid & swelling in trachea & lungs AM-PM 4NOV96;wet cough AM-PM;fever 101.5 PM & chills PM;h/a & less coughing 5NOV96;									Y	11/04/1996	11/04/1996	0	NONE	OTH	OTH	Estraderm	NONE	caines	pt sibling was paralysed for 2 dasy @ 2mo in 1963 w/OPV/DTP dose 1;~ ()~~~In Sibling		1						1	Chills; Cough; Headache; Lung disorder; Pulmonary oedema; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71320~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092734	12/10/1996	MO	41.0	41		F	12/04/1996	immed swelling, radiating from inj site;approx 3 inches above & below inj site;area of swelling, red & warm to touch;pt c/o dizziness & feeling faint;pt assisted to floor elevated legs BP & P WNL;ice applied to swelling area;				Y					Y	10/17/1996	10/17/1996	0		OTH	PVT	Calan SR, HCTZ	denied any		~ ()~~~In patient		1						1	Dizziness; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71195~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0092735	12/10/1996	OH	65.0	65		F	10/09/1996	just doesn't feel well, chills, shallow, rapid breathing;				Y					Y	10/09/1996	10/09/1996	0		PUB	PVT	unk	stated heart trouble	unk	~ ()~~~In patient		1						1	Chills; Dyspnoea; Hyperventilation; Malaise	FLU3~CONNAUGHT LABORATORIES~6F71275~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0092736	12/10/1996	IL	45.0	45		M	12/04/1996	pt recv vax 12NOV96 & arm became extremely sore 7PM;could not lift arm above shoulder height;approx 9PM pt became chilled;shivered uncontrollably for 4hr till fever came @ approx 1AM;violent h/a also during 9PM-1AM;									Y	11/12/1996	11/12/1996	0		PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Chills; Headache; Hypokinesia; Myalgia; Pyrexia; Tremor	FLU3~CONNAUGHT LABORATORIES~6F71307~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092738	12/10/1996	WV	39.0	39		F	10/18/1996	skin cool, clammy, fell to floor p/inj was given, no injury;									Y	10/18/1996	10/18/1996	0		PUB	PVT				~ ()~~~In patient		1						1	Hyperhidrosis; Injury	FLU3~CONNAUGHT LABORATORIES~6F71246~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092652	12/11/1996	TX	62.0	62		M	11/28/1996	adm on 2NOV96 w/weakness, progressing to quadraparesis;GBS dx;required intubation & ventilation;tx w/immunoglobulin, & then plasamaphoresis w/no improvement;cardiac arrest on 17NOV96;could not be resuscitated;	Y	11/17/1996			Y				N	10/01/1996	11/02/1996	32		UNK	UNK	inhaler for COPD (identity unk)		COPD, Crohn's disease;	~ ()~~~In patient		1						1	Asthenia; Cardiac arrest; Guillain-Barre syndrome; Hypoxia; Quadriplegia; Cardiac arrest; Guillain-Barre syndrome; Quadriplegia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Results in Death	Influenza
0092739	12/11/1996	UT	2.0	2	.5	M	12/06/1996	exposed to relative w/chicken pox;had 1 dasy mild fever, not ill-recv 5 pox;									Y	11/16/1995	11/23/1996	373		PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Dermatitis bullous; Pyrexia	FLU3~PFIZER\WYETH~4958111~1~IM~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|VARCEL~MERCK & CO. INC.~~UNK~~~VARICELLA (VARIVAX)~1	USA		Influenza
0092743	12/11/1996	WI	24.0			F		maculopapular rash on buttock & upper thigh, lower back & trunk;macular 4mm in diameter;appears to have devel in 2-3 episodes-pruritus;										10/17/1996	10/17/1996	0	NONE	UNK	UNK				~ ()~~~In patient		1						1	Pruritus; Rash maculo-papular	FLU3~PARKE-DAVIS~00786P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0092744	12/11/1996	MA	22.0	22		F	11/07/1996	red face w/blotchy rash on face;hot & cold spells x 2 days;									Y	11/04/1996	11/04/1996	0		PUB	PUB				~ ()~~~In patient	MA9622	1						1	Chills; Pyrexia; Rash maculo-papular; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71226~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092748	12/11/1996	ME	67.0			F	11/01/1996	acute serum sickness: fever, rash, proteinuria, arthralgias;				Y					Y	10/25/1996				PVT	PVT	NONE	sl back ache	NONE	~ ()~~~In patient		1						1	Albuminuria; Arthralgia; Condition aggravated; Pyrexia; Rash; Serum sickness	FLUX~UNKNOWN MANUFACTURER~6F71211~2~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0092759	12/12/1996	NJ	78.0	78		F	11/07/1996	arm in area of inj became red, w/raised pimple like areas, also itchy;noticed rxn approx 4 days p/shot;7NOV96 reporter spoke to pt pimples still present, appear to be healing;										10/28/1996	11/01/1996	4		PUB	PUB	high blood pressure med			~ ()~~~In patient	NJ9629	1						1	Acne; Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~6F71293~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092125	12/13/1996	NY	43.0	43		M	11/12/1996	began rash on Sunday palms of hands, under arms, groin;started DPH;saw MD on Monday who administered IV Pred;cont on PO pred;				Y					Y	11/07/1996	11/10/1996	3	NONE	PUB	PVT	NONE	NONE	allergic sulfa drugs	~ ()~~~In patient	NYS96072	1						2	Rash; Rash	FLU3~PFIZER\WYETH~4968152~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968152~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0092803	12/13/1996	CA	36.0	36		F	11/05/1996	24OCT96 pt recv flu vax, woke up next morning w/dysequilibrium, tinnitus progressive hearing loss in one ear;profound sensorineural hearing loss;								Y	N	10/24/1996	10/25/1996	1		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Coordination abnormal; Deafness; Tinnitus	FLU3~PFIZER\WYETH~4968145~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0092804	12/13/1996	CA	37.0			M	11/25/1996	pt started having flu-like sx day p/vax including fever, malaise, gen aching;seen in ER several days later exp peripheral neuropathy of arms & legs;unable to stand;hosp;dx GBS;severe autonomic collapse unable to resuscitate;pt died 31OCT96;	Y	10/31/1996							N	10/16/1996	10/17/1996	1		PUB	PUB	NONE	NONE	NONE		CA960127	1						1	Apnoea; Cardiac arrest; Guillain-Barre syndrome; Hypokinesia; Influenza; Myalgia; Neuropathy; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71212~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0092805	12/13/1996	NY	82.0	82		F	10/14/1996	4hr p/vax pt presented to ER w/nausea, vomiting, weakness, chills, t100.5;pt treated w/IV fluids, compazine & APAP;					Y	1			Y	10/08/1996	10/08/1996	0	CBC, urinalysis, SMA profile, CXR	PVT	PVT	pt on Coumadin, Lasix, Potassium, digoxin, Metoprol	NONE	hx afib, hx CVA	NONE~ ()~~~In patient	NYS96064	1						1	Asthenia; Chills; Dehydration; Nausea; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71211~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0092827	12/13/1996	MA	73.0	73		F	11/15/1996	gen, confluent, macular erythema w/macularpap component;									Y	11/06/1996	11/07/1996	1		PVT	UNK	Diabetz, Tiazac, Mesnum, acupril	NONE	NKA: HTN, TYIIDM, myasthenia gravis	~ ()~~~In patient		1						1	Rash maculo-papular	FLU3~PARKE-DAVIS~01286P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0092835	12/13/1996	MO	35.0	35		F	12/03/1996	28OCT96 pt c/o high BP, lightheadedness, weakness, muscle twitching, dizziness;				Y					N	10/28/1996	10/28/1996	0	CST scan, chem profile, thyroid	PUB	PUB	PPD by Connaught lot# 242813 given 28OCT96;	NONE	NONE	~ ()~~~In patient	MO96066	1						1	Asthenia; Dizziness; Hypertension; Muscle twitching	FLU3~CONNAUGHT LABORATORIES~6F71239~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TTOX~CONNAUGHT LABORATORIES~5L71095~4~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0092844	12/13/1996	MI	47.0	47		M	11/12/1996	1 to 2 wk p/vax both last & this yr pt exp constant prickling feeling;electrical impulse shock feeling @ noc which wake pt;putting ben gay on relieved snsation;lasted about 3wk;									Y	10/10/1996	10/17/1996	7	NONE	PUB	PVT	NONE	NONE	hayfever	pt exp prickling feeling like electrical impulse shock feeling w/flu vax 2yr ago~ ()~~~In patient	MI96175	1						1	Pain; Paraesthesia	FLU3~PARKE-DAVIS~00586P~2~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0092845	12/13/1996	MI	43.0	43		F	10/23/1996	pt recv vax 11OCT96; c/o numbness in that arm, hard, muscle cramps in neck, redness/swellling @ site of inj;started physical therapy on 21OCT96 has been off work since 15OCT96;exp pain in tt arm;pain @ inj site & down lt arm;				Y					Y	10/11/1996	10/11/1996	0	21OCT96 physical therapy eval cutaneous neuro	PUB	PUB	NONE	nONE	E-Mycin, Flagyl, Demerol infect	pt exp localized irritation w/flu vax 3-4 yr ago;~ ()~~~In patient	MI96176	1						1	Bronchitis; Hypertonia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Myasthenic syndrome; Neck pain; Paraesthesia	FLU3~PARKE-DAVIS~00586P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0092846	12/13/1996	NY	60.0	59		F	10/18/1996	inner ear affected-ataxia, nausea, vomit, inability to stand;some diarrhea x 2 days;Meclizine prescribed by PMD;									Y	10/16/1996	10/17/1996	1	NA	PUB	OTH	NONE	NONE	NONE	~ ()~~~In patient	NYS96065	1						1	Asthenia; Coordination abnormal; Ear disorder; Hypokinesia; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E3086GG~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0092847	12/13/1996	NY	59.0	59		F	10/30/1996	onset of local itching on rt upper arm 2-3 days p/inj;also devel a hard, red, warm area 4 in diameter that reamins 1wk p/inj;pt using hydrocortisone oint to area for itchign;									Y	10/22/1996	10/24/1996	2		PUB	PUB	HCTZ, Monopril, Prilosec,Clinoril, APAP	NONE	NONE	~ ()~~~In patient	NYS96066	1						1	Injection site hypersensitivity; Injection site mass; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4968173~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~6F81189~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0092848	12/13/1996	NY	82.0	82		F	10/30/1996	2 days p/vax pt devel severe itching, along w/redness & warmth @ rt upper arm;area size of fist;also devel gen achey feeling, chest congestion w/o fever;saw MD 28OCT96 tx w/med;				Y					Y	10/16/1996	10/18/1996	2		PUB	PUB	Vasotec	NONE	NONE	~ ()~~~In patient	NYS96067	1						1	Chest pain; Injection site hypersensitivity; Injection site mass; Myalgia; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4968173~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~6F81889~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0092849	12/13/1996	NY	32.0	32		M	11/04/1996	1015AM pt exp itching, hives on back, face flushed, lightheaded & anxious 1045AM; seen @ clinic recv DPH & Celestine;rx given for PRed;				Y					Y	11/01/1996	11/01/1996	0	NONE	PUB	PUB	NONE	NONE	NKA	NONE~ ()~~~In patient	NYS96068	1						1	Anxiety; Dizziness; Pruritus; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4968170~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092850	12/13/1996	NY	62.0	62		M	11/04/1996	very sore rt deltoid w/some redness;began next day p/vax & lasted 5 days;									Y	10/29/1996	10/30/1996	1		PUB	PUB	high BP medicine;sugar pill	NONE	NONE	~ ()~~~In patient	NYS96070	1						1	Injection site hypersensitivity; Injection site pain; Myalgia; Vasodilatation	FLU3~PFIZER\WYETH~4968173~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~6F81189~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0092855	12/13/1996	MI	49.0	49		F	12/02/1996	diff w/mobility of lt arm p/inj;for 2 wk pt has fibromyalgia needed to use muscle relaxor & it did help movement of arm;pt consulted w/pvt MD;				Y					Y	11/14/1996				PUB	UNK		NONE	NONE	~ ()~~~In patient	MI96179	1						1	Hypokinesia; Myalgia	FLU3~PFIZER\WYETH~4968172~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092862	12/13/1996	FL	88.0	88		M	11/18/1996	6hr p/shot appetite dec, confused, to bed-lethargic;calling milk orchard;next AM daughter wnt to pt room had snipped a linen into pieces;incontinent, t101;ached all over especially ribs;dec energy;slept a lot;advised to see MD;									N	11/13/1996	11/13/1996	0		PUB	PUB	NONE	NONE	daughter states none	NONE~ ()~~~In patient	FL96087	1						1	Anorexia; Confusional state; Malaise; Myalgia; Personality disorder; Pyrexia; Somnolence; Urinary incontinence	FLU3~MEDEVA PHARMA, LTD.~E3106HD~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0093137	12/13/1996	IL	65.0	65		M		bathroom excessive-perspired profusely;passed out & fell injuring cheek bone & area around eye, injuring shoulder;rushed to ER;pt checked finding was dehydrated-given IV tx which returned BP to nl;				Y					Y	11/04/1996	11/13/1996	9		PUB	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Dehydration; Hyperhidrosis; Hypotension; Injury; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0093138	12/13/1996	IL				F		very sick, arms hurt real bad, persisted for 3-4wk;									Y	11/12/1996	11/17/1996	5		PUB	OTH				~ ()~~~In patient		1						1	Malaise; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0091710	12/16/1996	CA				U	12/11/1996	pt exp paralysis in fingers & feet, had slurred speeach 1wk p/vax;hsop & dx w/GBS;no past hx of GBS;MD feel that this is vaccine related;					Y				U	10/09/1996	10/16/1996	7		UNK	UNK				~ ()~~~In patient	CO6942	1						2	Guillain-Barre syndrome; Myasthenic syndrome; Paralysis; Peroneal nerve palsy; Speech disorder; Guillain-Barre syndrome; Paralysis; Speech disorder	FLU3~CONNAUGHT LABORATORIES~6F71289~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71289~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0092496	12/16/1996	CA	58.0	58		M	12/11/1996	pt recv vax 18OCT96 & 4NOV96 pt reported that was seen by MD & dx w/GBS;the condition is reported to be resolving w/o seqquelae;				Y					U	10/18/1996	11/04/1996	17		UNK	UNK				~ ()~~~In patient	CO7017	1						2	Asthenia; Guillain-Barre syndrome; Hypokinesia; Hypotonia; Myasthenic syndrome; Paraesthesia; Rhinitis; Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~6F71234~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71234~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0092867	12/16/1996	MO	76.0			M	12/11/1996	pt recv vax 25OCT96 & 30OCT96 pt began feeling weak;31OCT96 pt had hyperasthesias & was very agitated;pt hosp acting very confused tx w/meds;1NOV96 c/o sore throat & had a t103.3;					Y				Y	10/25/1996	10/30/1996	5	CT scan was unremarkable;LP results- protein 30, glucose 60, WBC none or one;CSF cult negative;repeat LP 30nov96 protein 38,glucose 68,WBC 102, RBC 158	UNK	UNK				~ ()~~~In patient	CO6976	1						1	Agitation; Asthenia; CSF test abnormal; Confusional state; Hyperaesthesia; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0092872	12/16/1996	MO	59.0	59		M	12/12/1996	NOV96 pt c/o numbness in the fingers & hands;10NOV96 to 11NOV96 pt c/o not feeling right, inc numbness in the feet & calves & walking diff (frunk duck walk); 12NOV96 pt was adm to hosp for s/s of inc BP;could not walk;dx GBS;				Y	Y				U	10/30/1996	11/09/1996	10		UNK	UNK			HTN, prostate, frequency	~ ()~~~In patient	CO7025	1						1	Gait disturbance; Guillain-Barre syndrome; Hypertension; Hypokinesia; Myasthenic syndrome; Paraesthesia; Personality disorder	FLU3~CONNAUGHT LABORATORIES~6S71306~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0092873	12/16/1996	IL	1.9	1	.9	F	12/12/1996	pt recv vax 2DEC96 & next day it was repoted that pt had devel a high temp, sz & apnea;pt was given CPR;			Y	Y					U	12/02/1996	12/03/1996	1		UNK	UNK				~ ()~~~In patient	CO7026	1						1	Apnoea; Cardiac arrest; Convulsion; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71297~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0092875	12/16/1996	AZ	58.0	58		F	12/12/1996	4NOV pain in lower back;8NOV feet began to feel asleep & tingled all the time;10NOV hands/ginger tingled all the time MD sciatic nerve problem of dx; pt can walk but not welll;17NOV emergency ambulance to to hosp extreme pain & unable walk'				Y	Y	10			U	10/25/1996	11/04/1996	10	spinal tap, blood tests, blood gas;also many tests done prior to dx of GBS that were unnecessary;	OTH	OTH	Ziac	NONE	high blood pressure	NA~ ()~~~In patient		1						1	Asthenia; Back pain; Gait disturbance; Guillain-Barre syndrome; Hypokinesia; Neuropathy; Pain; Paraesthesia; Arthralgia; Back pain; Guillain-Barre syndrome; Hypokinesia; Myalgia; Paraesthesia	FLU3~PFIZER\WYETH~4968164~1~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968164~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0092878	12/16/1996	PA	48.0	48		M	12/11/1996	pt recv vax 18NOV96 & 4 to 5 hr post vax pt devel an inc in hearing loss & a humming type of sound;in infect reported;9DEC96 audiogram revealed sl downward shift @ 250 cycles per second;pt is a diabetic taking micronase;				Y					U	11/18/1996	11/18/1996	0		UNK	UNK	Micronase		diabetes	~ ()~~~In patient	CO7000	1						1	Deafness; Tinnitus	FLU3~CONNAUGHT LABORATORIES~6F71248~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0092880	12/16/1996	KY	57.0			M	12/11/1996	pt devel chest pains & SOB 24hr p/vax;pt reportedly had no chronic hlth problems, no hx of CHD, no prev hx of chest pains;EKG was non specific;ISO enzymes negative;however a global systolic dysfunction dx via cardiac echo;dx myocarditis									U					UNK	UNK				~ ()~~~In patient	CO6949	1						1	Cardiovascular disorder; Chest pain; Dyspnoea; Myocarditis	FLU3~CONNAUGHT LABORATORIES~6F71316~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092889	12/16/1996	CO	50.0	50		M	12/05/1996	24hr p/vax fever 102, redness, swelling @ site of inj;tx Levloz, Ibuprofen;rxn resolved;									Y	11/12/1996			NONE	PVT	UNK	NONE	redness swelling @ site	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71320~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~440420~1~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0092896	12/16/1996	AR	62.0	62		F	10/22/1996	pt recv vax 10AM TC from son states pt has had few vax a/, almost blacked out & have diff w/equilibrium;having nausea & some diarrhea;									Y	10/22/1996	10/22/1996	0		PUB	PUB	unk	nausea/diarrhea;		~ ()~~~In patient	AR9684	1						1	Coordination abnormal; Diarrhoea; Nausea; Syncope	FLU3~CONNAUGHT LABORATORIES~6F71307~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092897	12/16/1996	PA	47.0	47		F	12/04/1996	severe swelling lt arm axillary adenopathy;									Y	11/13/1996	11/14/1996	1		PVT	PVT	altegra;Vitamin E	NONE	latex allergy;sleep apnea	~ ()~~~In patient		1						1	Lymphadenopathy; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~6F71274~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0092899	12/16/1996	OH	45.0	45		F	12/09/1996	+sweats, nausea for 4wk;									N	09/23/1996	09/27/1996	4		PVT	PVT		joint pain in shoulder & arms		NA~ ()~~~In patient		1						1	Hyperhidrosis; Nausea	FLU3~CONNAUGHT LABORATORIES~6F71195~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092901	12/16/1996	NJ	76.0	75		M	12/05/1996	1wk p/vax pt c/o upset stomach adm to hosp;19NOV96 w/ c/o weakness, unable to stand;pt in renal failure;				Y	Y				N	10/17/1996	11/19/1996	33		MIL	OTH		NONE	allergy PCN	~ ()~~~In patient		1						1	Asthenia; Dyspepsia; Hypokinesia; Myasthenic syndrome; Renal failure	FLU3~PFIZER\WYETH~4968200~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0092903	12/16/1996	NC	79.0	79		F	11/26/1996	from 13NOV thru 18NOV or + knot in stomach caused food to go both up & down;BM & vomit;then a fainting-to be all day & noc w/some vomiting;no appetite, unsteady on feet;pains in upper GI;BM liquid only for 2-3 days;day 4 very painful									Y	11/03/1996	11/13/1996	10		PUB	OTH	Diazide, Premarin	NONE	NONE	~ ()~~~In patient		1						1	Abdominal pain; Anorexia; Diarrhoea; Dizziness; Gait disturbance; Gastrointestinal disorder; Syncope; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0092904	12/16/1996	NC	74.0	74		F		awakened about MN, lt side of intestines hurting, went to toilet but no diarrhea until several days ate;upper abd hurt off & on, especially if late anything;felt like vomiting but did not;np appetite; until 13NOV;did drink liquids;									Y	11/03/1996	11/05/1996	2		PUB	PUB	APAP, Voltaren, Captopril, Darvocet	NONE	NONE	~ ()~~~In patient		1						1	Abdominal pain; Anorexia; Diarrhoea; Gastrointestinal disorder; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0092908	12/16/1996	PA	31.0	31		F	11/15/1996	15min p/vax exp lightheadedness, chest felt heavy & throat tight;BP became higher epi given & sent by amb to hosp ER;given antihistamine & pred & sent home, tightness gone;told allerg & not to have again;				Y					Y	11/15/1996	11/15/1996	0		OTH	OTH				~ ()~~~In patient		1						1	Chest pain; Dizziness; Hypersensitivity; Hypertension; Laryngospasm	FLU3~PFIZER\WYETH~4968206~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092909	12/16/1996	PA				F	11/14/1996	11012hr p/vax awoke in middle of noc w/difficult breathing;became panicked;sat up for 1hr-no sx;went to bed, difficult breathing lying down;sat up to sleep;awoke-no sx since;did not call MD;									Y	11/11/1996	11/12/1996	1		OTH	OTH				~ ()~~~In patient		1						1	Agitation; Dyspnoea; Personality disorder	FLU3~PFIZER\WYETH~4968206~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092910	12/16/1996	PA	32.0	32		F	10/31/1996	1hr p/vax hands & bottom of feet became itchy;2-3hr later they became fiery hot;next days same sx in pubic area;took DPH;could work & function w/o diff;5 days later pt w/hives,went to ER given 2 inj & prescription for hydrox YZ;				Y					Y	10/23/1996	10/23/1996	0		OTH	PVT				pt mother had similar, but lesser, rxn to flu vax;~ ()~~~In patient		1						1	Pruritus; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4968170~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0092911	12/16/1996	PA	51.0	51		F	10/31/1996	24hr p/vax pt noticed a few hives on lt leg & lt side of back;waited to see if had any more, pt is a hiver;was not uncomfortable; 2 days later called MD to ask if OK to take DPH;confirmed & told pt to never take flu shot again;									Y	10/28/1996	10/29/1996	1		OTH	PVT				pt daughter had similar but much more severe rxn this yr w/flu vax~ ()~~~In patient		1						1	Urticaria	FLU3~PFIZER\WYETH~4968170~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092915	12/16/1996	MO	27.0	26		F	12/11/1996	pt reports onset of strange feeling on lt site of face 4PM 19NOV96;recv flu vax 2PM same day;woke up following morning unable to smile on that side, lt eye twitching;had inc tearing from lt eye & no taste w/tongue;c/o mouth droop;upset;				Y					U	11/19/1996	11/19/1996	0	NA	OTH	UNK		NONE	obesity, nicotine addiction	NONE~ ()~~~In patient		1						1	Affect lability; Ageusia; Facial palsy; Lacrimal disorder; Muscle twitching	FLU3~CONNAUGHT LABORATORIES~6F71227~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0092916	12/16/1996	IN	58.0	57		F	11/25/1996	pt states recv flu vax approx 615AM 15NOV96 & immed area became red & itchy;bandaid removed because states was possibly allergic to topic cortaid cream to inj site;DPH;									Y	11/15/1996	11/15/1996	0		OTH	PVT	Ventolin & beclovent	nONE	hx asthma-poss allergy to tape	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLU3~PARKE-DAVIS~01386P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0092919	12/16/1996	OK	55.0	55		F	12/06/1996	injected arm has reddened area form top of shoulder to anticubital space;area is warm;no rash or raised area noted;pt c/o body aches, low fever, malaise s/sx 4 days;									Y	12/04/1996	12/05/1996	1	NONE	PUB	PUB	NONE	sinusitis, strained muscle	NKDA	NONE~ ()~~~In patient	OK9648	1						1	Malaise; Myalgia; Pyrexia; Vasodilatation	FLU3~PARKE-DAVIS~01186P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1626B~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0092920	12/16/1996	OK	58.0	58		F	11/01/1996	beginning 1 inch below inj site devel reddened areas on arm that turned dark & feel warm to touch lt arm 8NOV96 called doing well no f/u needed;									Y	10/30/1996	10/31/1996	1		PUB	PUB	Fucralfate, Carafate, Coptopril, Metidine, Sertraline, Paenytayn, Estrogen, Netacolepramid		PCN	NONE~ ()~~~In patient	OK9647	1						1	Injection site hypersensitivity; Skin discolouration; Vasodilatation	FLU3~PARKE-DAVIS~01286P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1626B~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0092922	12/16/1996	FL				F		severe erythema lt deltoid area;Ibuprofen, warm compresses x 3 days;									Y	11/04/1996	11/04/1996	0	NONE	MIL	PVT		UNK	mentally deficient individual	~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~4968171~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092923	12/16/1996	WA	50.0	50		F	11/25/1996	pt states had flu shot on 12NOV96 & on 16NOV96 pt devel swelling & soreness under lt arm & into lt breast;									Y	11/12/1996	11/16/1996	4	Mammogram	OTH	OTH	Lopressor;Lanoxin, Synthroid, Entex LA, Nazalide, Estrogen	NONE	premature heart beats, TMJ sinus-allergies	NONE~ ()~~~In patient		1						1	Myalgia; Oedema peripheral	FLU3~PARKE-DAVIS~00786P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0093173	12/16/1996	OK	57.0	56		F	12/06/1996	pt presented w/redness & swelling from upper deltoid to anticubital space, lt arm;c/o 3 days s/s of weakness, body aches, fever & malaise;both vaccines given in lt arm d/t rt arm amputation;									Y	12/02/1996	12/03/1996	1	NONE	PUB	PUB		insect bite	PCN	NONE~ ()~~~In patient	OK9649	1						1	Asthenia; Injection site hypersensitivity; Injection site oedema; Malaise; Myalgia; Oedema peripheral; Pyrexia; Vasodilatation	FLU3~PARKE-DAVIS~01186P~2~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1626B~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0092581	12/17/1996	OH	90.0	90		F	12/12/1996	pt had pain in rt shoulder x 2wk p/vax then devel lt shoulder as well then both hips assoc w/malaise & diff doing anything;dx as polymyalgia rheumatica responded to low dose steroids;fell during fl sustained leg laceration, wrist fx				Y					Y	10/04/1996	10/05/1996	1	29SEP95 ESR 26;14NOV96 ESR 59;23NOV96 ESR 35;	PVT	PVT	Synthroid, pilocarpine, timoptic, aldactazide	NONE	HTN, glaucoma, osteoarthritis, osteoporosis, modular degeneration;	~ ()~~~In patient		1						3	Arthralgia; Malaise; Myalgia; Pain; Red blood cell sedimentation rate increased; Malaise; Myalgia; Pain; Red blood cell sedimentation rate increased; Arthralgia; Hypokinesia; Malaise; Myalgia	FLU3~MEDEVA PHARMA, LTD.~E30366A~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~E30366A~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLU3~MEDEVA PHARMA, LTD.~E3036GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~3	USA	Emergency room visit	Influenza
0092925	12/17/1996	IA	60.0	60		F	10/30/1996	recv vax 24OCT96 2PM & w/in 10min flet funny;BY 245PM unable to swallow, dysphoritic, diff breathing;BP 190/110;given med a/emergency transport to hosp;@ hosp recv more meds then adm to f/o  rxn triggering a MI d/c 25OCT96;			Y		Y					10/24/1996	10/24/1996	0	Chem profile, Artirial Gases, Cardiac enzymes, multiple EKG;CXR 2 view's over 24OCT96 & 25OCT96;	UNK	UNK			NONE;NKA	~ ()~~~In patient		1						1	Dysphagia; Dyspnoea; Hyperhidrosis; Hypertension; Malaise	FLU3~CONNAUGHT LABORATORIES~6F71316~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0092933	12/17/1996	MN	63.0	63		M	11/26/1996	pt devel a 2 cm necrotic ulcer @ inj site p/vax (unk lot#);pt medical history is remarkable for COPD & HTN;no other info available;this case was reported by a MD;				Y					U	10/16/1996			NONE	MIL	OTH	unk	NONE	hx COPD & HTN	~ ()~~~In patient	0010150960141	1						1	Injection site reaction; Necrosis	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0093111	12/17/1996	WA	71.0	71		F	12/13/1996	4 days post vax pt began to have sinus problems w/sl temp;no site rxn;bronchial cough;dx w/asthmatic bronchitis;benzonatate, Keflex;				Y					N	10/14/1996	10/19/1996	5		OTH	PUB		NONE	insect bite, PCN, sulfa, osteomyletis, breast cancer;	~ ()~~~In patient		1						1	Asthma; Bronchitis; Cough; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0093115	12/17/1996	MO	4.0	4		F	11/26/1996	pt recv vax 22NOV96 9AM & had temp of 102-103;APAP & Ibuprofen given throughout day, along w/DPH because of prev mild rxn;temp down to 100-101;site red, swollen w/rash;530PM began to c/o severe stomach pain & began to vomit;c/o muscle pain									Y	11/21/1996	11/22/1996	1		PUB	PUB		runny nose	sensitivity to expectorants	pt exp rash/fever @ age 4 w/flu vax dose 1 & sibling exp rash w/flu dose 1@ age;~ ()~~~In patient	MO96067	1						1	Abdominal pain; Injection site hypersensitivity; Injection site oedema; Myalgia; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71322~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0093122	12/17/1996	NY	37.0	37		F	12/07/1996	following day very tired & arm sore;the second day p/vax had severe diarrhea & vomiting lasting 3 days;no treatment;									Y	11/26/1996	11/28/1996	2		PVT	PVT	FLonase, Chlortrimetron	4 days prior had a stomach bug	prone to sinus infections	~ ()~~~In patient		1						1	Asthenia; Diarrhoea; Myalgia; Vomiting	FLU3~PFIZER\WYETH~4968200~1~A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~UNKNOWN MANUFACTURER~438670~1~A~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0093125	12/17/1996	MA	45.0	45		F	12/12/1996	pt recv vax 1NOV96 on 6NOV not feeling well, fatigue-aches 7NOV temp 102 which returned to nl;following wk discomfort achy back of neck on 14NOV;vomiting 18NOV; to urgent care inc discomfort, paralysis, rt side of face advanced to lt				Y					N	11/01/1996	11/06/1996	5	MRI-spinal tap; inc protein;cervical neck nl;EMG r/o GBS;blood work r/o lyme disease;	PVT	OTH	Ventolin inhaler	NONE	asthma, allergies, pollens, dust	NONE~ ()~~~In patient		1						1	Asthenia; Facial palsy; Malaise; Myalgia; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0093136	12/18/1996	FL				F		c/o tongue tenderness & tingling in hands;									Y					OTH	UNK				~ ()~~~In patient		1						1	Paraesthesia; Tongue disorder	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0092463	12/19/1996	AZ	91.0	91		M	12/12/1996	2-3wk prior to vax pt exp rectal bleeding;labs were neg & vax was administered;pt had a rxn VS were nl;4-5 days p/vax speech became slurred, inc confusion, inc lethargy;became non-responsive;died 31OCT96	Y	10/31/1996							N	10/23/1996	10/28/1996	5	NONE	UNK	PUB	NONE	rectal bleeding	HTN, dementia, hypothroidism, sz, prostate CA	~ ()~~~In patient	AZ9632	1						2	Apnoea; Cardiac failure; Diarrhoea; Electrolyte imbalance; Hypoxia; Syncope; Vomiting; Confusional state; Somnolence; Speech disorder; Stupor	FLU3~PFIZER\WYETH~4968162~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968162~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Results in Death	Influenza
0092464	12/19/1996	AZ	95.0	95		F	12/12/1996	pt recv vax & had been afeb no unusual sx;31OCT96 when staff went to room to take pt lunch, pt was unresponsive;family called-stated DNR-pt died 31OCT96;	Y	10/31/1996							N	10/27/1996	10/31/1996	4	NONE	PUB	PUB	Cimetidine, THorazine		DMIII, CHF, schizophrenic, recurrent UTI	~ ()~~~In patient	AZ9631	1						2	Dyspnoea; Peripheral vascular disorder; Pupillary disorder; Speech disorder; Syncope; Stupor	FLU3~PFIZER\WYETH~4968162~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968162~1~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Results in Death	Influenza
0093142	12/19/1996	OK	58.0	58		M	12/09/1996	pt recv flu vax 29OCT96 & exp tingling sensation & back pain NOV 12, 14, & 15; severe back pain & numbness in face & lower leg;16 & 17 & 18NOV complete facial & lt leg paralysis;(no prior illness);dx GBS			Y	Y	Y	5		Y	N	10/29/1996	11/13/1996	15	CAT scan, MRI, back & chest x-ray, EKG;	OTH	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Facial palsy; Guillain-Barre syndrome; Hypokinesia; Lacrimal disorder; Myasthenic syndrome; Paraesthesia; Speech disorder	FLU3~PARKE-DAVIS~~2~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0093166	12/20/1996	MA	68.0	67		F	12/03/1996	sore throat, ache feeling, coughing, t102, ATB given w/o effect;27NOV CXR looked okay;3DEC t100.1, sl better cough;				Y					U	11/14/1996	11/16/1996	2		PUB	PUB	eye-timoptic filogel	NONE	glaucoma	~ ()~~~In patient	MA9626	1						1	Cough; Myasthenic syndrome; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71226~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0093169	12/20/1996	MA	60.0	60		F	12/11/1996	2-3PM 10OCT recv vax;6-8PM 10OCt throat felt closed, cold & achy-took 1 rest a/bed (2 pills);AM 11OCT eye swollen shut w/discharge-cold & achy subsided-slept all day-drowsy;12OCT tired w/small cough;14OCT back to work;did									Y	10/10/1996	10/10/1996	0		PUB	PUB			allergies to lentils, dry beans, starch	~ ()~~~In patient	MA9628	1						1	Chills; Cough; Drug ineffective; Face oedema; Lacrimal disorder; Laryngospasm; Myalgia; Somnolence	FLU3~CONNAUGHT LABORATORIES~6F71226~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0093170	12/20/1996	MA	47.0	47		M	12/11/1996	10OCT recv vax;11OCT weak;12OCT cramps, diarrhea, hot flashes, gassy;									Y	10/10/1996	10/11/1996	1	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MA9627	1						1	Asthenia; Diarrhoea; Eructation; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71226~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0093171	12/20/1996	NY	44.0	44		F	12/16/1996	swollen lips x 24hr-denies difficulty breathing;pruritic pin-point red rash migrating form arms, to legs, back for 2 wk;extreme restlessness & jumping out of skin;no ER visit;no meds taken;									Y	10/22/1996	10/22/1996	0	NONE	OTH	OTH	VItamin C, Baby aspirin	NONE	NKA/no illness	NONE~ ()~~~In patient		1						1	Face oedema; Nervousness; Pruritus; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~6F71217~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092186	12/23/1996	MA	84.0	84		M	11/18/1996	pt devel pain in lt forearm approx 24hr p/vax;several days later noticed pea-sized lump near the radial-ulnar joint of the lt arm;believes the lump to be a recurrence of Merkel cell carcinoma, & believes flu vax caused the recurrence				Y					Y	10/28/1996	10/29/1996	1		PVT	OTH	unk	NONE	Merkel cell carcinoma of the lt ear, dx 10yr ago, tx w/surgery & radiation	~ ()~~~In patient	896330041L	1						2	Pain; Skin nodule; Condition aggravated; Neoplasm; Pain; Skin nodule	FLU3~PFIZER\WYETH~4968174~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968174~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0093218	12/23/1996	AZ				F	11/26/1996	pt recv vax & devel GBS & was hosp;no further info was available @ the date of this report;					Y				U					OTH	OTH	unk	unk		~ ()~~~In patient	896337006L	1						1	Guillain-Barre syndrome	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0093223	12/23/1996	MA	37.0	37		M	12/17/1996	devel GBS type illness approx 2wk post vax;			Y		Y	6			Y	11/15/1996	11/27/1996	12	+nerve conduction studies, s/w demyelinating process;	PVT	PVT	Percocet	sinusitis recovering URI	ceclor	~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLU3~MEDEVA PHARMA, LTD.~E3106GB~1~IM A~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0093239	12/23/1996	GA	65.0	65		M	12/18/1996	pt devel facial burning & itching @ 4 pm; exam 18dec96 @ 10am revealed facial, neck & upper trunk urticaria. tx: seldane 60mg.										12/17/1996	12/17/1996	0		OTH	OTH				~ ()~~~In patient		1						1	Pain; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4968209~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0093240	12/23/1996	AR	52.0	52		F	12/02/1996	pt states that left arm began hurting immediately after vax; it hurt all the way down pt arm. pt states that the nurse gave vax on top of shoulder; now one month later pt states she is unable to use arm. pt has not seen MD										11/02/1996	11/02/1996	0		OTH	PUB				~ ()~~~In patient	AR9687	1						1	Hypokinesia; Pain	FLU3~CONNAUGHT LABORATORIES~6F71307~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0093245	12/23/1996	NE	61.0	61		M	12/16/1996	W/IN 24 hr PT EXP SX OF INFLUENZA; SEVER H/A;PHOTOPHOBIA;POLYMYALGIA;MALAISE;3 wk LATER EXP PULMONARY SX W/ DRY THEN PRODUCTIVE COUGH. SX PERSIST. EOSINOPHIL COUNT 21% @ NORMAL DIFFERENTIAL				Y					U	11/02/1996	11/03/1996	1	CBC; UA; CHEST FILM	MIL	MIL	NONE	NONE	SULFA ALLERGY	~ ()~~~In patient		1						1	Cough; Headache; Influenza; Lung disorder; Malaise; Myalgia; Photophobia; White blood cell disorder	FLU3~PFIZER\WYETH~4968208~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0093254	12/23/1996	IN	11.0	11		F	10/12/1996	N & V; CLAMMY;Weakness									Y	10/12/1996	10/12/1996	0		UNK	UNK				~ ()~~~In patient		1						1	Asthenia; Hyperhidrosis; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71275~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092506	12/24/1996	CA	74.0	74		M	10/29/1996	recv vax 24oct96 @ 12pm; @ 6pm pt was vomiting & pain in left upper abdomen; 12am was worst- md met pt @ er. pt had abnormal EKG,elevated WBC & BP; chest x-ray abnormal; admitted to hosp					Y				U	10/22/1996	10/22/1996	0	EKG, chest x-ray, elevated BP, WBC	PUB	PUB	lupron	none		~ ()~~~In patient	CA960144	1						2	Abdominal pain; Electrocardiogram abnormal; Hypertension; Leukocytosis; Lung disorder; Vomiting; Abdominal pain; Electrocardiogram abnormal; Hypertension; Leukocytosis; Lung disorder; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71213~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71213~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0093226	12/24/1996	CO	43.0	43		F	12/18/1996	GBS a slight weakness noted 2 wk post vax; gradual worsening- sent to neurologist mid nov. referred further dx finally made 27nov96, sat pt worsened & hosp 17dec96				Y	Y	7			U	10/08/1996	10/29/1996	21	EMG	PVT	UNK		none	essential family tremor (FH of autoimmune dx)	~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome	FLU3~PARKE-DAVIS~276P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0093277	12/24/1996	PA	82.0	82		F	12/19/1996	Lethargy, Loss of strength, profound muscle aches and inability to move shoulders				Y					Y	10/31/1996	11/03/1996	3	none	PVT	PVT	Azmacort, Serevent, Theodur 30 mg. daily	Asthma		~ ()~~~In patient		1						1	Asthenia; Hypokinesia; Myalgia; Somnolence	FLU3~MEDEVA PHARMA, LTD.~E3086GA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0093278	12/24/1996	IN	42.0	42		M		Intense general itching and hives. Pt seen in ER Received IV meds. (Meds unknown)				Y					Y	11/30/1996	11/30/1996	0	none	UNK	UNK	Zoloft, Trazodone	none	none			1						1	Pruritus; Urticaria	FLU3~PARKE-DAVIS~01386P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0093280	12/24/1996	NY	49.0	49		F	12/19/1996	21 hr post flu shot, stinging sensation rt. lower lip, then swelling w/heat rt. lower lip, Then both sides of lower lip w/angioedematous and ears slightly swollen, tongue and breathing norm. impression AE to flu vax - ddx missed insec				Y					N	12/17/1996	12/18/1996	1	none done	PVT	PVT	Pravachol, Estrogen Patch, Vasoretic	none	angioedema from insect bite	~ ()~~~In patient		1						1	Angioneurotic oedema; Condition aggravated; Face oedema; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0093291	12/24/1996	CA	74.0	74		F	12/06/1996	Pt exp sudden onset of cough and back pain 8 hr post vax. Denies temp, headache, dizziness. Has been essentially bedridden due to back pain. Cough subsided next a.m. Pt. told not likely related to vax but would report				Y					N	10/18/1996	10/18/1996	0		PUB	PUB	Insulin	none	Type II diabetes mellitus	~ ()~~~In patient	CA960148	1						1	Back pain; Cough	FLU3~CONNAUGHT LABORATORIES~6F71212~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0093654	12/24/1996	TN	2.0	2	.9	F	08/29/1996	pt recv vax & the same day t102-103R which responded to APAP but fluctuated;it spiked while asleep;pt was very irritable & devel pneumonia;ER or MD visit required;pt was found to be non-responder;				Y					Y	10/28/1995				UNK	UNK	Septra, Aerosol		asthma	pt exp fever & pneumonia w/flu vax unk dose;~ ()~~~In patient	960126091	1						1	Agitation; Drug ineffective; Infection; Pneumonia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~SMITHKLINE BEECHAM~~1~~~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0093231	12/26/1996	KS	68.0	68		M	12/18/1996	back, chest pain; 25oct seen by MD; abd pain, severe constipation, unable to sleep @ night, hip pain, a lot of weakness, numbness of extremities, some confusion, drooping of mouth, loss of balance;dx w/ guillain barre synd by neurolog				Y	Y	12			N	10/07/1996	10/20/1996	13	MRI brain, neck, spine, abd-neg, EMG, spnal tap=CSF inc protein;EKG-neg	PUB	PUB	none	none	none	~ ()~~~In patient		1						1	Arthralgia; CSF test abnormal; Confusional state; Coordination abnormal; Facial palsy; Guillain-Barre syndrome; Insomnia; Paraesthesia	FLU3~PFIZER\WYETH~4968157~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0093301	12/27/1996	PA	48.0	48		F	10/12/1996	pt showed sx of pharyngitis,nasal congestion w/in 24 hr; pt developed fever 3 days later									U	09/30/1996	10/01/1996	1		OTH	PUB	ibuprofin	none	sinusitus	~ ()~~~In patient	PA9667	1						1	Pharyngitis; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0093302	12/27/1996	PA	66.0	66		F	10/18/1996	pt exp tingling in 3,4,5th finger, up right arm to shoulder,down right side to toes; rx w/ acetaminophen									N	10/01/1996	10/17/1996	16		PUB	PUB				~ ()~~~In patient	PA9666	1						1	Paraesthesia	FLU3~CONNAUGHT LABORATORIES~6F71293~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0093416	12/30/1996	ID	26.0	26		F	11/20/1996	approx 48 hr post vax pt devel hives especially on face, around eyes, that were red & itching. Has had recurrent hives all over  hands.  To ER  times 3 w/ swollen tongue, throat construction resolved w/ meds; improved @ time of report				Y					U	10/29/1996	11/01/1996	3		UNK	UNK		no	reports previous similar episode @ age 13; never dx	~ ()~~~In patient		1						1	Laryngospasm; Pruritus; Tongue oedema; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4968162~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0093417	12/30/1996	AK	14.0	14		F	12/17/1996	supra clavicular adenopathy ( 6 by 8 cm) matted nodes occurring w/ axillary adenopathy 7 days post subvirian flu vax									Y	12/02/1996	12/04/1996	2	CBC & MRI scan of neck & chest	PVT	PVT		none		~ ()~~~In patient		1						1	Laboratory test abnormal; Lymphadenopathy	FLU3~CONNAUGHT LABORATORIES~6F71320~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0093418	12/30/1996	MO	38.0	38		F	11/26/1996	29oct96 6 am awakened feeling feverish; noticed red spots on abd spreading to whole body & limbs. reported to hlth dept & saw MD who Rx anti-itch topical meds. 26nov96 recovered completely in about 4 days. continues on same meds w/ no									Y	10/28/1996	10/29/1996	1		PUB	PVT	4 antidepresents	none	none except depression	~ ()~~~In patient		1						1	Pruritus; Pyrexia; Rash maculo-papular	FLU3~PARKE-DAVIS~01186P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0093425	12/30/1996	CO	47.0	47		F	11/26/1996	pt recv vax; rash on legs and arms and torso; was prescribed claritin;				Y					Y	11/05/1996	11/06/1996	1	none	PVT	PVT	Zoloft	none	none	none~ ()~~~In patient	CO96059	1						1	Rash	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0093426	12/30/1996	CO	63.0	63		M	11/12/1996	pt recv vax;devel bumps on legs and waist;hive like welts on torso, under arms, legs; itching; low grade fever and sore mouth;									N	10/30/1996	10/30/1996	0		PUB	PUB	multi vits;	none	none	no hx~ ()~~~In patient	CO96058	1						1	Pruritus; Rash maculo-papular; Stomatitis; Urticaria	FLU3~PFIZER\WYETH~4968165~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092508	12/31/1996	VA				F	11/18/1996	GBS 2nd influenza injection							Y	Y			11/03/1996		normal MRI scan & t.spine--normal spinal tap	UNK	UNK			none	~ ()~~~In patient		1						2	Guillain-Barre syndrome; Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation,Disabling	Influenza
0092581	12/31/1996	OH	90.0			F		pt recv vax;lt arm pain following vax; devel pain in rt arm and hips; ESR found to be elevated; had resolution of pain and malaise w/in 24 hr of corticosteroid inj;										10/04/1996			ESR inc from baseline 26 to 59	UNK	UNK	orticosteroid inject;	none		~ ()~~~In patient		1						2	Arthralgia; Malaise; Myalgia; Pain; Red blood cell sedimentation rate increased; Malaise; Myalgia; Pain; Red blood cell sedimentation rate increased; Arthralgia; Hypokinesia; Malaise; Myalgia	FLU3~MEDEVA PHARMA, LTD.~E30366A~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~E30366A~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLU3~MEDEVA PHARMA, LTD.~E3036GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~3	USA		Influenza
0092585	12/31/1996	OK	42.0			M	11/26/1996	pt recv vax; exp psynosis, shallow respiration and diminished heart sound via stethoscope; to er and tx w/ dph;				Y					Y	10/18/1996	10/18/1996	0		UNK	UNK		none	none	~ ()~~~In patient		1						2	Bradycardia; Cyanosis; Hypoventilation; Bradycardia; Cyanosis; Hypoventilation	FLUX~UNKNOWN MANUFACTURER~4968163~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4968163~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0092652	12/31/1996	TX	62.0			M	11/28/1996	admitted on 02nov96 w/ weakness, progressing to quadraparesis. GBS dx.  required incubation and ventilation; treated w/ immunoglobulin, then plasmaphoresis w/ no improvement. cardiac arrest on 17nov96 could not be resuscitated	Y	11/17/1996					Y		N		11/02/1996			UNK	UNK			COPD, Gohr;s disease	~ ()~~~In patient		1						2	Asthenia; Cardiac arrest; Guillain-Barre syndrome; Hypoxia; Quadriplegia; Cardiac arrest; Guillain-Barre syndrome; Quadriplegia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Results in Death	Influenza
0092875	12/31/1996	AZ	58.0	58		F	12/04/1996	approx 12 days post flu vax pt complained of lower back pain, numbness in feet & ankles & pain in back of knees; meds given; Dx: sciatica.  pt brought to ER per ambulance complaining of same sx and unable to walk Dx: GBS				Y	Y	10			Y	10/25/1996	11/05/1996	11	spinal tap, amonial level, CBC, PT, PTT, VDRL, SMAC-hyponatremia	PUB	PUB	Zyac for high BP		hypertension	~ ()~~~In patient	AZ9715	1						2	Asthenia; Back pain; Gait disturbance; Guillain-Barre syndrome; Hypokinesia; Neuropathy; Pain; Paraesthesia; Arthralgia; Back pain; Guillain-Barre syndrome; Hypokinesia; Myalgia; Paraesthesia	FLU3~PFIZER\WYETH~4968164~1~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968164~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0093439	12/31/1996	MI	32.0	31		F	11/19/1996	pt recv flu vax @ 11am on 06nov96; pt devel hives & facial/hand swelling by 6pm.  pt took benadryl, by the next am pt had increased facial swelling & eyes swollen shut. pt was taken to ER & treated w/ meds; hives for 11 days				Y	Y					11/06/1996	11/07/1996	1		UNK	UNK				~ ()~~~In patient		1						1	Face oedema; Oedema peripheral; Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71247~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0093443	12/31/1996	MN	51.0	51		M	12/16/1996	pt recv vax; unable to give blood now; antilymphocyte virus on screening test;									U	12/23/1996			antilymphocyte virus on screening test;	PUB	PUB	none	none		~ ()~~~In patient	MN96064	1						1	Infection; Laboratory test abnormal	FLU3~PFIZER\WYETH~4968163~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0093448	12/31/1996	NM	46.0	46		M	11/05/1996	pt recv vax; woke up w/ very weak legs which spread to arms and rest of body, lasted 2 days;										10/22/1996	10/23/1996	1		UNK	UNK			sulfa allergy; hep at age 13;	~ ()~~~In patient		1						1	Myasthenic syndrome	FLU3~PFIZER\WYETH~4968198~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0093450	12/31/1996	CO	22.0	22		M	11/06/1996	pt recv vax; local redness noted; redness and swelling also noted and resolved later;										11/04/1996	11/05/1996	1		UNK	UNK	Zantac Chonazepam Bisacodyl	none	none	~ ()~~~In patient		1						1	Injection site hypersensitivity; Oedema peripheral; Vasodilatation	FLU3~PFIZER\WYETH~4968175~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0093451	12/31/1996	MA	60.0	60		F	11/30/1996	pt recv vax; had asthma exacerbation over next 24 hr - not relieved w/meds; er visit required; sx resolved;				Y						11/11/1996	11/11/1996	0		UNK	UNK		seen that day for asthma w/PF 300 - mild wheezing	asthma aug96	~ ()~~~In patient		1						1	Asthma; Condition aggravated	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0093452	12/31/1996	PA	62.0	62		M	10/11/1996	pt recv vax; d for 3 days; fever and general malaise approx 1 1/2 hr p/ inject;										10/04/1996	10/04/1996	0		UNK	UNK			IDDM; former smoker	~ ()~~~In patient		1						1	Diarrhoea; Malaise; Pyrexia	FLU3~PFIZER\WYETH~6F71221~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0093454	12/31/1996	CA	57.0			F	11/26/1996	pt recv vax; rt deltoid became weak and w/ in one wk, abscess on rt axilla;md felt this was secondary to bacteremia introduced by flu shot; tx w/ atb; doing fine									Y	09/19/1996	09/19/1996	0	blood culture - neg; inc WBC	UNK	UNK	ASA		nka	~ ()~~~In patient		1						1	Abscess; Infection; Leukocytosis; Myasthenic syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0093502	01/02/1997	MN	32.0	32		F	12/13/1996	pt exp numbness, weakness, bilateral bells palsy. exam & test consistent w/ GBS					Y	10			Y	11/13/1996	11/22/1996	9		OTH	OTH	none	none	none	~ ()~~~In patient	MN96046	1						1	Asthenia; Facial palsy; Guillain-Barre syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~6F71276~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0093515	01/02/1997	MN	47.0	47		M	11/18/1996	pt recv vax; denies any pain; felt achy; flu like sxs; dull ache in lt arm; had flu shots before w/ no problems;				Y					U	10/28/1996	10/30/1996	2		OTH	UNK			none	~ ()~~~In patient	MN96063	1						1	Influenza; Myalgia; Pain	FLU3~PFIZER\WYETH~4968163~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0093516	01/02/1997	MN	58.0	58		F	11/19/1996	pt recv vax;hurt in area of shot; few days later, was having sharp pain in arm and up into shoulder;has not seen MD;									U	10/28/1996	10/30/1996	2		OTH	UNK	none	none	hx bursitis, stomach ulcer, sensitive to meds;	~ ()~~~In patient	MN96062	1						1	Injection site pain; Myalgia	FLU3~PFIZER\WYETH~4968163~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0093517	01/02/1997	MN	52.0	52		F	11/19/1996	pt recv vax; arm sore; lt arm started to ache; depends on position and movement of arm; lateral movements hurt the most; reports inc pain w/ immobility;									U	10/28/1996				OTH	OTH	none	none	sulfa, doxycycline; breast ca;	~ ()~~~In patient	MN96061	1						1	Hypokinesia; Myalgia; Pain	FLU3~PFIZER\WYETH~4968163~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0093518	01/02/1997	MN	45.0	44		F	11/18/1996	pt recv vax; began to have sharp pains, worse at site; lateral movements cause most pain; worst pain in shoulder joints; shooting pains at site;				Y					U	10/28/1996	10/29/1996	1		OTH	UNK	none	none	no allergies, hx of bursutus lt arm;	~ ()~~~In patient	MN96060	1						1	Arthralgia; Hypokinesia; Myalgia; Pain	FLU3~PFIZER\WYETH~4968163~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0093519	01/02/1997	MN	33.0	33		M	11/19/1996	pt recv vax; c/o sharp pains; denies pain since 13nov; used ibuprofen;									U	10/28/1996				OTH	UNK	none	none	sl heart murmur	~ ()~~~In patient	MN96059	1						1	Pain	FLU3~PFIZER\WYETH~4968163~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0093520	01/02/1997	MN	54.0	54		M	11/19/1996	pt recv vax; arm burned during shot; pain started 2nd week especially when lifting and lateral movements in arm and up to shoulders;denies any pain at site; shoveling hurt arm; took acetaminophen; pain better now, seems to be going away;									U	10/28/1996	11/04/1996	7		OTH	UNK	none			~ ()~~~In patient	MN96058	1						1	Hypokinesia; Myalgia; Pain	FLU3~PFIZER\WYETH~4968163~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0093521	01/02/1997	MN	38.0	38		M	11/18/1996	pt recv vax; c/o arm sore and tight about 2 days p/ shot; ached all over in joints by 2nd wk; c/o pain in lt shoulder blade, up into neck; arm sore and stiff;				Y					U	10/28/1996	10/28/1996	0		OTH	UNK	none	none	none	~ ()~~~In patient	MN96057	1						1	Arthralgia; Headache; Hypertonia; Myasthenic syndrome; Neck pain; Oedema peripheral; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4968163~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0093522	01/02/1997	MN	44.0	43		F	11/18/1996	pt recv vax; c/o numbness for a few minutes;next am , arm felt different and that night, pain arm; intermittent sharp pain stabbing pain in lt arm; pain and stiffness worsen w/ immobility at night;				Y					U	10/28/1996	10/30/1996	2		OTH	UNK	none	none	none	~ ()~~~In patient	MN96056	1						1	Anxiety; Hypertonia; Hypokinesia; Myalgia; Myasthenic syndrome; Pain; Paraesthesia; Tremor	FLU3~PFIZER\WYETH~4968163~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0093523	01/02/1997	MN	25.0	25		F	11/19/1996	pt recv vax;arm sore because vax burned while pt being vaccinated; pain was not too bad until 1 wk later; had chest cold w/ fever; arm hurt of laid on it wrong or w/ lateral movements; arm still sore but improved; inc pain w/ immobility;									U	10/28/1996	11/07/1996	10		OTH	UNK	none	none	none	~ ()~~~In patient	MN96055	1						1	Chills; Hypokinesia; Lung disorder; Myalgia; Pain; Pyrexia	FLU3~PFIZER\WYETH~4968163~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0093524	01/02/1997	MN	35.0	34		F	11/19/1996	pt recv vax;sharp pain in lt arm; pain in certain arm positions as crossing to opposite shoulder and reaching behind back; to MD for baby visit;									U	10/28/1996	10/29/1996	1		OTH	UNK	none	none	none	~ ()~~~In patient	MN96054	1						1	Hypokinesia; Pain	FLU3~PFIZER\WYETH~496163~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0093525	01/02/1997	MN	58.0	58		F	11/18/1996	pt recv vax;arm felt unusually heavy and numb for 1/2 hr then sore until wk later; tingling and sharp pain in arm especially when trying to reach for things; to md;				Y					U	10/28/1996	10/28/1996	0		OTH	PUB		none	estrogen for hot  flashes;	~ ()~~~In patient	MN96053	1						1	Arthralgia; Asthenia; Hypertonia; Hypokinesia; Insomnia; Myalgia; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4968163~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0093526	01/02/1997	MN	43.0	43		F	11/27/1996	pt recv vax; arm very sore, red, 3 diam raised, warm spot;									Y	11/04/1996	11/06/1996	2	none	PUB	PUB	none	none	had melanoma removed several wk previous	~ ()~~~In patient	MN96052	1						1	Injection site hypersensitivity; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4968139~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0093527	01/02/1997	MN	51.0	50		F	11/27/1996	pt recv vax; soreness in deltoid after injection; had bursitis type pain and limited ROM; improving slowly										11/08/1996	11/11/1996	3		PUB	PUB		none	keflex	~ ()~~~In patient	MN96051	1						1	Bursitis; Hypokinesia; Myalgia	FLU3~PFIZER\WYETH~4968205~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0093528	01/02/1997	MN	42.0	42		F	11/27/1996	pt recv vax; devel redness and swelling; used ice pack; seems to develop bursitis by 10nov96; ibuprofen taken; joint pain and limited ROM continues;									N	11/08/1996	11/08/1996	0	none	PUB	PUB	none	none	none	~ ()~~~In patient	MN96050	1						1	Bursitis; Hypokinesia; Oedema peripheral; Vasodilatation	FLU3~PFIZER\WYETH~4968205~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0093530	01/02/1997	MN	44.0	44		F	11/22/1996	pt recv vax; forearm, hand, and fingers felt numb and tingly; sx subsided but mobility of arm to reach across chest,behind back cause discomfort; aches at noc;there has been no change in discomfort									U	11/04/1996	11/06/1996	2	none	PUB	PUB	prednisone; thedur; lotensin;	sinusitis w/ cold sxs	asthma	~ ()~~~In patient	MN96048	1						1	Hypertonia; Hypokinesia; Myalgia; Paraesthesia	FLU3~PFIZER\WYETH~4968163~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0093531	01/02/1997	MN	43.0	43		F	12/11/1996	pt recv vax; 3 days later noticed red pin point rash on chest and back after am shower; rash very itchy; took dph; rash cont and had spread down arms and legs; to see MD in am;									N	12/04/1996	12/07/1996	3		PUB	PUB	paxipam	none	premenstrual syndrome sz; allergy to pcn and sulfa;	~ ()~~~In patient	MN96047	1						1	Pruritus; Rash maculo-papular	FLU3~PFIZER\WYETH~4968163~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0093533	01/03/1997	NY	73.0			F	12/19/1996	pt exp an extremely unusual rxn 04oct96.  info recv 27dec96 from MD indicates that after vax she devel a rash, pain in her wrists and metacarpal joints & redness of her hands.pt seen in ER. DX: serum sickness-like illness				Y	Y	11			Y	10/02/1996	10/02/1996	0		PUB	OTH			hx of diabetes	~ ()~~~In patient	0010150960048	1						1	Arthralgia; Pain; Rash; Serum sickness; Urticaria; Vasodilatation	FLU3~PARKE-DAVIS~00376P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0093534	01/03/1997	ID	32.0	32		F	12/17/1996	pt exp intense vomiting & diarrhea for 3 days post vax & partial left arm paralysis, sweating & low grade fever. pt also had a 20 lb weight loss but has regained 8 lb. nerves there/ no reflexes. pt has not recovered from left arm para				Y				Y	N	11/05/1996	11/07/1996	2	MRI (BRAIN, CERVICAL,THORACIC)-neg; spinal tap-neg	PVT	PVT			adverse event following prior vax: flu sx	~ ()~~~In patient	0010150960152	1						1	Diarrhoea; Hyperhidrosis; Hyporeflexia; Paralysis; Pyrexia; Vomiting; Weight decreased	FLU3~PARKE-DAVIS~00176P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Disabling	Influenza
0093535	01/03/1997	KY	66.0	66		F	12/19/1996	9 days after recv vax pt was seen by MD w/ an inject site rxn that was described as a reddened area, 5mm in diameter w. serious drainage. meds given, no change.  03dec96 seen by MD, biopsy performed which revealed low grade malignancy				Y					Y	11/21/1996	11/21/1996	0	biopsy	PVT	OTH	feldene, cimetidine	none	hx of polio- 1944; arthritis, reflux esophagitis, no hx of previous rxn to flu vax.	~ ()~~~In patient	0010150960153	1						1	Injection site abscess; Injection site hypersensitivity; Skin cancer	FLU3~PARKE-DAVIS~00276P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0093537	01/03/1997	VT	71.0	71		F	12/04/1996	ascending paresthesias, left leg weakness w/ transverse myelitis: hosp for 5 days sudomedrol. sx occurred w. 36 hr of influenza vax; no other expandable cause for sx.					Y			Y	N	10/18/1996	10/19/1996	1	MRI of entire spine; CT scan head WNL. LP-high protein, al IgG. EMG WNL	PVT	OTH				~ ()~~~In patient	VT96004	1						1	Laboratory test abnormal; Myasthenic syndrome; Myelitis; Paraesthesia; Asthenia; Chest pain; Hemiplegia; Myelitis; Neuropathy; Pain; Paraesthesia; Tremor	FLU3~PFIZER\WYETH~4968170~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968170~1~A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation,Disabling	Influenza
0093538	01/03/1997	VT	58.0	58		F	12/02/1996	18oct96 woke w/ tingling in legs, weakness, worked all day. 20oct96 went to MD w/ above complaints legs going on me 21oct96 went to ER-admitted. 22oct96 transferred to diff hosp.  Dx: GBS				Y	Y	29			U	10/15/1996	10/18/1996	3	GBS	OTH	PVT	since 11oct96 biaxin for bronchitis/ pneumonia	recovering from pneumonia/bronchitis		~ ()~~~In patient	VT96005	1						1	Asthenia; Guillain-Barre syndrome; Hypokinesia; Myasthenic syndrome; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E3036GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0093539	01/03/1997	VT	54.0	54		F	12/02/1996	18nov96- headache, legs  and back ache;20dec96- went to MD for complaints; 22nov96- again went to MD for same complaints & weakness in legs-using walker; 23nov96-went to ER, unable to walk at all; pt admitted; still in ICU 02dec96; GBS				Y	Y	10			U	11/08/1996	11/18/1996	10	GBS	PVT	PVT	none	none	none	~ ()~~~In patient	VT96006	1						1	Back pain; Guillain-Barre syndrome; Headache; Hypokinesia; Myasthenic syndrome; Pain	FLU3~PFIZER\WYETH~4968170~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0093540	01/03/1997	VT	59.0	59		F	12/24/1996	29nov96- woke up feeling fine, w/in hr felt picky numbness, muscle weakness & eventually could not stand;went to med outpatient ctr; 30nov96- sx worse- went to ER admitted & still hospitalized; GBS				Y	Y	25			U	11/15/1996	11/29/1996	14	GBS	PVT	PVT	albuterol, alupent, calan premarin, theophylline	none	chronic obstructive pulmonary disease; hypertension	~ ()~~~In patient	VT96007	1						1	Guillain-Barre syndrome; Hypokinesia; Myasthenic syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~6F71221~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0093543	01/03/1997	CA	58.0	58		F	10/18/1996	edema & erythema @ inject site plus tenderness, devel w/in 24 hr of injection & present today. SX are diminishing according to pt.										10/16/1996	10/17/1996	1		OTH	OTH		none	none	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~6F71247~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0093549	01/06/1997	CT	31.0	31		F	12/27/1996	headache, pain in neck & jaw; does not feel like control over muscles; floating feeling when laying down; dizziness, uncoordinated, does not feel in control; chronic neck pain going down back			Y	Y					N	10/31/1996	11/01/1996	1	CAT scan of Head & neck-normal; various blood work, heart monitor all normal	OTH	PVT	tohorman, norvesc	high BP		had rxn before~ ()~~~In patient		1						1	Arthralgia; Back pain; Chest pain; Coordination abnormal; Dizziness; Headache; Paraesthesia; Arthralgia; Diarrhoea; Hypertonia; Hypokinesia; Muscle twitching; Myasthenic syndrome; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~6F71236~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71236~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening	Influenza
0093553	01/06/1997	AZ	60.0	59		M	12/28/1996	flu- feverish for 3 days; bed ridden, severe head & body aches; lethargy- lack of energy				Y					N	10/15/1996	12/21/1996	67	MD checked chest and ears- okay	PUB	PUB	post vax- aspirin & robitussin	none	allergy- horse serum, penicillin, toxidiomytosis	~ ()~~~In patient	AZ9714	1						1	Asthenia; Headache; Malaise; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0093563	01/06/1997	WV	55.0	55		F	01/05/1997	pt exp paralysis of lt side of face;				Y					N	10/02/1996	10/05/1996	3		UNK	UNK				~ ()~~~In patient		1						1	Facial palsy	FLU3~MEDEVA PHARMA, LTD.~E3026GA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0093566	01/06/1997	IL	41.0	41		F	12/13/1996	29NOV pt recv vax & 3DEC lt perinial pain;4DEC lt knee, lt heel pain rx'd w/APAP, Ibuprofen;6DEC resolved;exp radiculopathy , inflammation of the nerves, diffuse over the body;				Y					Y	11/29/1996	12/03/1996	4	neuro exam neg; ob/gyn exam wnl	PUB	PUB	Synthroid	NONE	s/p thyroidectomy for cept;	NONE~ ()~~~In patient	CO7037	1						1	Abdominal pain; Arthralgia; Neuritis; Neuropathy; Pain; Pelvic pain	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0093567	01/06/1997	OH	24.0	24		M	12/17/1996	temp of 100-101 per pt;indurated rt deltoid area 6x 3;erythema surrounding induration;concurrent URI;				Y					Y	10/21/1996	10/23/1996	2	NA	PVT	PVT	FLonase, Theodur, Proventil, MDI, Beclovent, Claritin-D	URI	asthma, hyperlipidemia, chronic sinusitis h/o proteinuria	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~6F71194~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~436821~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0093573	01/06/1997	GA	59.0	59		F	12/04/1996	pt states w/in 30-40 min p/vax head, face, chest & neck became bright splochy red & swollen & stinging sensation & thraot itched;pt took DPH;				Y					Y	11/26/1996	11/26/1996	0	NONE	PUB	PVT	Zantac, Vitamins	NONE	allergy to niacin & sulfur;	~ ()~~~In patient	GA96173	1						1	Oedema; Oedema peripheral; Pain; Pharyngitis; Rash maculo-papular	FLU3~PARKE-DAVIS~1386P~2~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0093577	01/06/1997	GA	68.0	68		F	10/25/1996	pt called 24OCT in AM c/o swelling & pain @ inj site;pt told to use cold compresses & could try DPH & see MD if not better by PM;pt to clinic 3PM area is red, warm to touch, swollen but not firm;				Y					U	10/23/1996	10/23/1996	0		PUB	UNK		NONE	NONE	~ ()~~~In patient	GA96167	1						1	Injection site oedema; Injection site pain; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E2996GA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~433402~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0093579	01/06/1997	GA	50.0	49		F	10/24/1996	pt recv vax & felt funny, maybe nerouvs, & jittery;hands were trembling & was sl pale; BP 8:45 150/102, 8:52 130/90;8:55 130/88;pt later reported still felt bad;?rxn to flu vax;				Y					Y	10/21/1996	10/21/1996	0		PUB	OTH	Theo-dur, Intal, azmacort, Amoxicillin, Syn-Rx-DM;	NONE	according to pt has hx of asthma, also had bronchitis for a few weeks right before vax;	NA~ ()~~~In patient	GA96165	1						1	Depersonalisation; Malaise; Nervousness; Pallor; Tremor	FLU3~MEDEVA PHARMA, LTD.~E3036GA~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0093581	01/06/1997	GA	55.0	55		F	10/18/1996	pt recv vax 16OCT96 & upon arising yesterday morning 17OCT96 noticed rt arm hurting & red around site;18OCT96 pt came to clinic;shot iste very warm, red area 40mm in width & length around site;instructed not to take flu shot again;									Y	10/16/1996	10/17/1996	1		PUB	PUB		NONE		~ ()~~~In patient	GA96163	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4968190~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0092612	01/07/1997	LA	67.0	67		F	01/03/1997	the same day of vax, pt devel transverse myelitis & was hosp & became quadriplegic.  The pt exp noted to be permanently disabling.	Y	11/19/1996	Y	Y	Y		Y	Y	N	10/21/1996	10/21/1996	0		PUB	PUB				~ ()~~~In patient	WAES96121718	1						2	Apnoea; Cardiac arrest; Hemiplegia; Myelitis; Quadriplegia	FLU3~PFIZER\WYETH~4968175~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~MERCK & CO. INC.~1626B~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Results in Death	Influenza
0093549	01/07/1997	CT	31.0	31		F	01/03/1997	immed dizziness then w/in a wk or so had heavy headed feeling, head/neck pain, other body muscle spasms, twitches & pain, tendon/joint pain, soreness in chest area & under arms;d, sweating, tingling hand/feet;swelling;				Y					U	10/31/1996	10/31/1996	0	various blood & other diagnostic tests shown nothing;	OTH	OTH	Tenormin, Diuretic for BP	NONE	high blood pressure	NONE~ ()~~~In patient		1						2	Arthralgia; Back pain; Chest pain; Coordination abnormal; Dizziness; Headache; Paraesthesia; Arthralgia; Diarrhoea; Hypertonia; Hypokinesia; Muscle twitching; Myasthenic syndrome; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~6F71236~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71236~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0093585	01/07/1997	IL	74.0	74		F	01/06/1997	Pt admitted to Hosp 18nov96 w/ c/o weakness  cephalgia. dx: GBS. D/C from Aehab 18dec96					Y				Y	10/21/1996	11/18/1996	28		PVT	PVT				~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome; Headache	FLU3~PFIZER\WYETH~4968139~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0093586	01/07/1997	IL	91.0	91		M	01/06/1997	pt admitted to hosp 19nov96 w/ dx of GBS. Is currently on the skilled nursing unit.					Y				N	10/03/1996	11/19/1996	47		PVT	PVT				~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLU3~MEDEVA PHARMA, LTD.~E2996FA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0093587	01/07/1997	MO	69.0	68		F	01/06/1997	had acute bronchitis @ this time. Hx of asthma; recv vax; first noted difficulty w/ balance late Nov.  Increasing vertigo, weakness, numbness of the face, low back, extremities, esp. finger-tips. Dx GBS.					Y				U	10/25/1996	12/21/1996	57		PVT	PVT	asmacort & bactrim DS 15 nov96	asthma, bronchitis	hx of asthma	~ ()~~~In patient		1						1	Asthenia; Coordination abnormal; Guillain-Barre syndrome; Paraesthesia; Vertigo	FLU3~PFIZER\WYETH~4968163~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0093588	01/07/1997	IL	57.0	57		U	01/06/1997	pt admitted to hosp 18dec96 for febrile illness w/ severe myalgias.  recv antiviral med for a single episode. Also had implanted antibiotic tx for dental abscess. Pt is in a wheel chair w/ acute ascending paralysis; GBS					Y				N	10/23/1996	11/29/1996	37		PVT	PVT				~ ()~~~In patient		1						1	Guillain-Barre syndrome; Myalgia; Paralysis; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E3086GG~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0093589	01/07/1997	IL	78.0	77		M	01/06/1997	pt admitted to hosp to ICU 16dec96 w/ c/o numbness & weakness of extremities; hx of pneumonia & suspected TB. AFB neg. Took INH for few days only. dx GBS; remains on skilled nursing unit.					Y				N	09/23/1996	12/16/1996	84		PVT	PVT		respiratory; pnuemonia, susptected TB		~ ()~~~In patient		1						1	Dyspnoea; Guillain-Barre syndrome; Myasthenic syndrome; Paraesthesia	FLU3~PARKE-DAVIS~00786P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0093595	01/07/1997	CA	77.0	76		M	01/02/1997	pt recv vax 19oct96; pt died 15oct96, not necessarily related, pt had terminal CHF disease	Y	10/15/1996							N	10/09/1996	10/15/1996	6		OTH	UNK	many	endstage CHF	ASA; novocaine; CHF terminal	~ ()~~~In patient		1						1	Unevaluable event	FLU3~CONNAUGHT LABORATORIES~6F71212~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0093602	01/07/1997	CA	77.0	77		M	01/02/1997	pt sz free x 6mo, recv flu vax & next day had sz;serum phenytoin levels drawn & WNL;				Y					Y	10/02/1996	10/02/1996	0		OTH	PUB	NTG, ASA, Elavil, Dilantin, Verapremil, Senakot, tetracych		NKDA; sz disorder	~ ()~~~In patient		1						1	Condition aggravated; Convulsion	FLU3~CONNAUGHT LABORATORIES~6F71212~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0093603	01/07/1997	MA	45.0	45		F	11/25/1996	eye irritation, itchy-sudden tickle cough-severe enough to make swallowing uncomfortable;(but no noticable throat swelling)-chills for 2hr then profuse sweating-shakes-heart palpatations-rapid pulse-feels faint-nausea;									Y	11/14/1996	11/14/1996	0		PUB	UNK		NONE	NONE	~ ()~~~In patient		1						1	Conjunctivitis; Cough decreased; Dizziness; Hyperhidrosis; Nausea; Palpitations; Tachycardia; Tremor	FLU3~CONNAUGHT LABORATORIES~6F71226~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0001D~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0093604	01/07/1997	CA	56.0	56		F	11/21/1996	localized pain;				Y					Y	10/18/1996	11/01/1996	14	NONE	PVT	UNK	Phenyfen, Zantac	NONE	sulfa	~ ()~~~In patient		1						1	Injection site pain	FLU3~PFIZER\WYETH~4968265~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0093611	01/07/1997	WA				F		hives x 6d									Y				NONE	PVT	UNK		NONE	asthma-allergic	NONE~ ()~~~In patient		1						1	Urticaria	FLU3~PFIZER\WYETH~4968164~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0093614	01/07/1997	TN	37.0	36		F	11/18/1996	began w/red, sore, swollen lt arm @ inj site;had raised red rash, & pain @ inj site;also these sx lasted 1wk;cont to have pain in arm lt arm-becomes more painful when moved;saw MD 8NOV96 given med, warm compresses				Y					U	10/14/1996	10/15/1996	1	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	TN96104	1						1	Hypokinesia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~6F71307~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~6D81109~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0093616	01/07/1997	TN	39.0	39		F	12/09/1996	mom states swelling & pain to lt arm 3DEC96;hot packs & APAP started Friday;6DEC96 talked to mom 1DEC96;instructed to cont hot packs, antiinflammatory med & elevate site to see MD;mom states arm much better 9DEC96;arm sore & red 12DEC96;									Y	12/03/1996	12/04/1996	1	NONE	PUB	UNK		NONE	NKA;sz under control w/dilantin & depokoate	~ ()~~~In patient	TN96106	1						1	Myalgia; Oedema peripheral; Pain	FLU3~CONNAUGHT LABORATORIES~6F71288~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0093618	01/07/1997	NY	41.0	40		F	12/06/1996	cold like sx;									Y	11/01/1996	11/01/1996	0		UNK	PUB	NONE	NONE	NONE	~ ()~~~In patient	BAMO36	1						1	Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0093619	01/07/1997	NY	46.0	46		M	11/05/1996	a rash on the rt arm;in the back of the lt side on the elbow, lt side;devel rash 3 days p/vax;									Y	10/11/1996	10/13/1996	2		PUB	UNK	NONE	NONE	NONE	~ ()~~~In patient	BAM029	1						1	Rash	FLU3~CONNAUGHT LABORATORIES~6F71289~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0093692	01/08/1997	TN	29.0			M	12/31/1996	pt recv vaxx 2DEC96;pt exp gross hematuria, fever, nausea, vomit, abd pain & confusion;pt hosp & was found p/work-up to have thrombocytopenic purpura;				Y	Y				N	12/02/1996			plate <10000; Creat elevated;HCT 13;	UNK	UNK				~ ()~~~In patient	960199531	1						1	Anaphylactoid reaction; Confusional state; Haematuria; Infection; Laboratory test abnormal; Pneumonia; Thrombocytopenic purpura; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~SMITHKLINE BEECHAM~~1~~~HEP A (HAVRIX)~1	USA	Hospitalisation	Influenza
0093644	01/09/1997	NJ	32.0	32		M	11/15/1996	t103 x 3-4 days w/malaise, myalgia, h/a, nausea, diarrhea, edema @ site w/ecchymosis (rt deltoid);				Y					Y	11/06/1996	11/07/1996	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	NJ9632	1						1	Diarrhoea; Ecchymosis; Headache; Injection site oedema; Malaise; Myalgia; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71293~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0331D~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0093646	01/09/1997	OK	79.0	79		F	10/29/1996	pt reports that on the noc of 24OCT96 when laid on rt side that shoulder hurt;then the next day rt elbow was red & swollen;went to MD who prescribed ATB & ice packs;by the next day arm did not hurt & red & swelling resolved;				Y					Y	10/24/1996	10/24/1996	0	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	OK9652	1						1	Oedema peripheral; Osteoarthritis; Pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~01286P~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~1626B~1~IM~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0092872	01/10/1997	MO	59.0	59		M	01/03/1997	GBS; nov96 pt c/o numbness in the fingers & hands. 10nov-11nov pt c/o not feeling right, increasing numbness in the  feet & calves & walking difficulties; pt admitted to hosp; 14nov96 pt could not walk; pt states totally unable to move				Y	Y	9			U	10/30/1996	11/09/1996	10		UNK	UNK	hytrin 1mg		hypertension, prostate, frequency	~ ()~~~In patient	CO7025	1						2	Gait disturbance; Guillain-Barre syndrome; Hypertension; Hypokinesia; Malaise; Paraesthesia; Personality disorder	FLU3~CONNAUGHT LABORATORIES~6F71306~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0093653	01/10/1997	TX	82.0	82		M	01/07/1997	pt recv vax 10SEP96 & it was reported that the rxn began a few days p/inj;pt hosp w/an acute infectious process, fever, rash, very ill;hosp for 2-3 days then 2-3 days p/discharge devel marked weakness in the lower extremities;adm 6OCT96;					Y	3			Y	09/10/1996	09/27/1996	17		UNK	UNK				~ ()~~~In patient	CO7053	1						1	Guillain-Barre syndrome; Infection; Malaise; Myasthenic syndrome; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~6E71277~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0093702	01/10/1997	OR				F	03/04/1996	arm a little sore p/flu shot;Thursday AM fever & achy;Friday 27OCT96 2AM awoke w/lt arm throbbing, dark purple circle, arm swollen from shoulder to elbow;noted blister;MD ofc saw ulceration @ site;poss cellulitis, swollen ax;sores in mouth				Y						10/25/1995	10/26/1995	1		PUB	PVT		NONE	Codeine	~ ()~~~In patient	OR9607	1						1	Cellulitis; Lymphadenopathy; Mouth ulceration; Myalgia; Oedema peripheral; Pyrexia; Skin discolouration; Skin ulcer	FLU3~PFIZER\WYETH~4958177~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0093725	01/10/1997	OR	43.0	43		M	10/30/1996	evening of vax nose & feet became red & itchy then vomitted once-then no further sx;states felt fine;									Y	10/22/1996	10/22/1996	0	NA	OTH	OTH	NONE	NA	mild HTN	pt exp LFT's w/Hep B dose 3~ ()~~~In patient	OR9634	1						1	Pruritus; Vasodilatation; Vomiting	FLU3~PFIZER\WYETH~4968162~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0093726	01/10/1997	OR	62.0	61		M	11/07/1996	lt arm, site of vax hives red raised & itching;lt arm sore mildly then hives cont to spread down lt arm & both shoulder & thighs;DPH PO helpful;										10/14/1996	10/29/1996	15		PUB	OTH		NONE	has allergy to iodine, shell-fish & eggs;	NONE~ ()~~~In patient	OR9635	1						1	Injection site hypersensitivity; Injection site pain; Pruritus; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E2976FP~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0093727	01/10/1997	OR	73.0	73		M	10/25/1996	aching a few dasy disappeared x 1wk, now back w/pain to thumb, staring @ shoulder;									N	10/11/1996	10/18/1996	7		PUB	OTH	NONE	NONE	osteoarthritis, nasal allergies	~ ()~~~In patient	OR9638	1						1	Myalgia; Pain	FLU3~PFIZER\WYETH~4968265~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0093731	01/10/1997	OR	57.0	57		F	12/23/1996	23OCT96 pt recv vax & had not immed problem, but w day later 25OCT96 till now c/o intermittent pain @ inj site;no fever/swelling/erythema/infect/bleeding or other complaint;				Y					U	10/23/1996	10/25/1996	2		OTH	PVT	Vitamins	NONE	mild asthma	pt sibling had adverse rxn to vax in militiary service @ 20yr~ ()~~~In Sibling	OR9642	1						1	Injection site pain	FLU3~PFIZER\WYETH~4968265~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~MERCK & CO. INC.~0649D~3~IM~RA~HEP B (RECOMBIVAX HB)~1	USA	Emergency room visit	Influenza
0093732	01/10/1997	WA	38.0	38		F	11/27/1996	localized pain & swelling site noted immed, felt like needle hit something, a buzzing feeling, like it filled something up;over 2 days was stable;48hr later noted pain in neck radiated down neck;dec strength & ongoing pain;									N	10/30/1996	10/30/1996	0		PUB	PUB		NONE	NONE	NONE~ ()~~~In patient	WA961310	1						1	Asthenia; Injection site oedema; Injection site pain; Myalgia; Myasthenic syndrome; Neck pain; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4968164~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0093737	01/10/1997	NC	68.0	68		U		pt recv vax & devel t102 to 104;pt states has not felt good since;eyes bothers pt & head hurst;feel dizzy & weak;don't eat very much;				Y					N	10/11/1996	11/29/1996	49		PUB	UNK				~ ()~~~In patient		1						1	Anorexia; Asthenia; Dizziness; Eye disorder; Gastritis; Headache; Malaise; Pyrexia	FLU3~PARKE-DAVIS~00676P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0093741	01/10/1997	OR	39.0	39		F	10/31/1996	pt recv vax 9OCT96 & devel dysquesia;lip palsy then 8hr later VII nerve palsy peripheral;steady recovery w/Pred;									Y	10/09/1996	10/21/1996	12	CT-sphinoid/sinus-nl;	OTH	OTH	NONE	NONE	NONE-marriage also 2-3days a/onset	NONE~ ()~~~In patient		1						1	Dyspepsia; Facial palsy; Paralysis	FLU3~PFIZER\WYETH~4968167~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0091631	01/13/1997	MA	40.0	40		M	10/24/1996	pt recv flu vax 8OCT96 & on 8OCT96 noted lt earache, tingling feeling lt side of face;pt seen @ hosp ER-probably Bell's palsy;seen in office 10OCT96 confirmed lt sided Bell's Palsy;								Y		10/08/1996	10/08/1996	0		UNK	UNK	Glucatrol, Cardura, Calan SR		DM, HTN	~ ()~~~In patient		1						2	Ear pain; Facial palsy; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Disabling	Influenza
0093231	01/13/1997	KS	68.0	68		M	12/18/1996	back/chest pain 25OCT seen by MD abd pain, severe constipation, unable to sleep @ noc, hip pain, inc weakness, numbness of extremities (rt side); some confusion drooping of mouth, inc weakness, loss of balance;numbness/weakness;dx GBS									N	10/07/1996	10/20/1996	13	MRI brain, neck, spine, abd negative; EKG negative;EMG ?;spinal tap=CSF protein;	PUB	PUB		NONE	NONE	~ ()~~~In patient		1						2	Asthenia; Back pain; Coordination abnormal; Facial palsy; Guillain-Barre syndrome; Laboratory test abnormal; Myasthenic syndrome; Paraesthesia; Guillain-Barre syndrome; Laboratory test abnormal; Myopathy	FLU3~PFIZER\WYETH~4968157~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~3	USA		Influenza
0093231	01/13/1997	KS	68.0	68		M	01/02/1997	GBS;					Y	12				10/07/1996	10/20/1996	13	CSF-elevated protein, EMG abn; MRI negative;	PUB	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						3	Asthenia; Back pain; Coordination abnormal; Facial palsy; Guillain-Barre syndrome; Laboratory test abnormal; Myasthenic syndrome; Paraesthesia; Guillain-Barre syndrome; Laboratory test abnormal; Myopathy	FLU3~PFIZER\WYETH~4968157~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~3	USA	Hospitalisation	Influenza
0093680	01/13/1997	NV	0.2	0	.2	F	01/09/1997	sever congestion, w/croupy cough-rx amox;			Y	Y					Y	12/09/1996	12/26/1996	17	x-ray chest-neg w/poss prog congest	PVT	PVT	Amoxicillan	NONE	NONE	~ ()~~~In patient		1						1	Cough; Dyspnoea; Laryngitis; Rhinitis	DTP~UNKNOWN MANUFACTURER~~1~~~DTP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|OPV~UNKNOWN MANUFACTURER~~1~~~POLIO VIRUS, ORAL (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0093690	01/13/1997	UT	80.0	80		M	12/23/1996	inc fever, unable to move, diarrhea;went to MD suspected bactersal ATB given;loss use of hands & legs;					Y		Y		N	10/23/1996	10/31/1996	8	spinal taps x 3, Cat Scan, 3 MRI's, nerve conduction test, sensation test;	PUB	PVT	ASA	NONE	arthritis, inc allergies	NONE~ ()~~~In patient	UT972501	1						1	Asthenia; Diarrhoea; Guillain-Barre syndrome; Hypokinesia; Infection; Myasthenic syndrome; Pyrexia	FLU3~PFIZER\WYETH~4968161~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0093693	01/13/1997	WA	41.0	41		F	12/31/1996	1wk p/vax pt devel numbness & tingling on rt side of face, next morning had lt face drooping, over days progressed to hands, feet, & tongue, numbness tingling weakness;went to ER dx w/Bell's palsy;neuro MD stated pt had GBS d/t vax;				Y					U	10/22/1996	11/04/1996	13	CT scan, heavy metal screen, neurological exam;neurologist wanted to do nerve testing pt declined;	OTH	OTH	Accetane, rameron	NONE	NONE	bad flu sx @ 5 w/flu vax dose 1;~ ()~~~In patient		1						1	Asthenia; Facial palsy; Guillain-Barre syndrome; Myasthenic syndrome; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E3096GB~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0093749	01/13/1997	MA	46.0	46		F	01/02/1997	extreme muscle & joint pain in both legs, diaphragm, shoulders, hands, h/a, t012 occurred about 2 wk p/vax & lasted about 8-9days;									Y	10/16/1996	10/30/1996	14	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Arthralgia; Headache; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71226~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0093764	01/13/1997	NJ	63.0	63		F	10/21/1996	pt recv vax 15OCT96 & 10 min p/vax became reddened, & tender to touch size twenty five cent piece, hardness increased, down arm & hand edematous;next day ahd diff lifting arm;c/o cont tenderness & diff lifting arm;									Y	10/15/1996	10/15/1996	0		PUB	PVT	Calcium, vitamin,cont vitamin	NONE		pt exp reddened, tende spot size of twenty cent piece w/dose 1 flu vax;~ ()~~~In patient	NJ971	1						1	Hypokinesia; Injection site hypersensitivity; Injection site mass; Injection site pain; Oedema peripheral; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71293~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0093771	01/13/1997	NJ	77.0	77		F	10/09/1996	pt recv vax & devel myalgia & arthralgia, abd pain followed by change of mental status;								Y		09/30/1996	10/02/1996	2	no spinal tap done as per daughter	UNK	UNK			hx of renal stone	~ ()~~~In patient		1						1	Abdominal pain; Arthralgia; Myalgia; Thinking abnormal	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0093772	01/13/1997	CT	44.0			U	11/06/1996	striking local erythema & induration @ site of f/u vax;											10/17/1996		NONE	UNK	UNK	NONE			~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~6F71286~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0093773	01/13/1997	CT	37.0			F	11/06/1996	striking local erythema & induration @ site of flu vax;											10/17/1996		NONE	UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~6F71286~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0093777	01/13/1997	MA				F		facial flushing, h/a, nausea psot vax;										10/15/1996	10/16/1996	1		UNK	UNK	Claritin-D x 4		enivronmental allergies-co workers ill w/cold	~ ()~~~In patient		1						1	Headache; Nausea; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0093694	01/14/1997	WA	76.0	76		M	01/08/1997	pt recv vax & dx GBS; weakness x 2mo;c/o numbness inner thighs using walker at home;c/o fear of falling, fatigue;muscle strength & reflexes improved over last wk of hosp;pt exp diff getting up from low chairs w/o arm rests;lost of DTR's;			Y		Y	10			N	10/10/1996	11/10/1996	31		PVT	PVT		NONE		~ ()~~~In patient		1						1	Guillain-Barre syndrome; Hypokinesia; Hyporeflexia; Infection; Myasthenic syndrome; Nail disorder; Paraesthesia; Pneumonia	FLU3~PARKE-DAVIS~00966P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation	Influenza
0093695	01/14/1997	PA	88.0	88		M	01/02/1997	pt recv vax 28OCT96 & 14DEC96 pt devel a cough & rhinitis;symmetrel was prescribed; 2 days later 16DEC96 pt t103 & put on APAP & ATB;temp down to 99.8 w/in 4 hr;pt expired that day cause unk. The death certificate states aspiration.	Y	12/16/1996							N	10/28/1996	12/14/1996	47		OTH	OTH	ASA, Cytotec, Voltaren, synthroid	NONE REPORTED	hx of hypothyroidism, pre renal azotemia, CVA (old) - lt hemiparesis, CHF, HTN, osteoarthritis, intermittent atrial fibrillation, COPD		0010150970006	1						1	Cough; Infection; Pneumonia; Pyrexia; Respiratory disorder; Rhinitis	FLU3~PARKE-DAVIS~00696P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0093696	01/14/1997	PA	91.0	91		F	01/02/1997	pt recv vax 28OCT96 & 15DC96 pt devel a cough, restlessness, malaise, anorexia & elevated temp of 102;APAP & symmetrel prescribed;2 days later 17DEC96 pt was afeb but cough worsened;pt on ATB following day 18DEC96 pt expired-cause unk;	Y	12/18/1996							N	10/28/1996	12/15/1996	48	NONE PROVIDED	UNK	UNK	unk	NONE REPORTED	hx of dementia, CAD, HTN, COPD, hiatal hernia, osteoarthritis, angina, hypokalemia		0010150970007	1						1	Anorexia; Coronary artery disease; Dementia; Hypertension; Infection; Lung disorder; Malaise; Pneumonia	FLUX~UNKNOWN MANUFACTURER~00696P~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0093697	01/14/1997	PA	86.0	86		F	01/02/1997	pt recv vax 28OCT96 & 4NOV96 pt devel a cough & congestion & was treated w/med;pt devel t99.0, anorexia & malaise;5 days later 23DEC96 pt expired-cause unk;	Y	12/23/1996							N	10/28/1996	11/04/1996	7	NONE PROVIDED	OTH	OTH	Vasotec, Antivert, Multivitamni, TUMS, Vitamin C	NONE	hx of dementia, postional vertigo, HTN, mild renal failure, multiple allergies;		0010150970008	1						1	Anorexia; Cardiac arrest; Cough; Dementia; Malaise; Pneumonia; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~00696P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0093698	01/14/1997	PA	90.0	89		F	01/02/1997	pt recv vax 28OCT96 & 18DEC96 pt devel cough, congestion, elevated temp of 99.8, anorexia;2 days later 20DEC96 pt expired-cause unk;	Y	12/20/1996							N	10/28/1996	12/18/1996	51	NONE PROVIDED	UNK	UNK	Vasotec	NONE	hx of HTN, dementia, irritable bowel synd, legally blind, diverticulitis, anemia		0010150970009	1						1	Anorexia; Cough; Hypotension; Infection; Pneumonia; Pyrexia; Rhinitis; Sepsis	FLUX~UNKNOWN MANUFACTURER~00696P~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0093789	01/14/1997	MI	63.0	63		F	12/11/1996	pt recv vax & had redness & swelling size of grapefruit where pneumonia shot was giving the day a/ rt arm;also c/o soreness wider the at arm, rt side of neck & throat;instructed pt to go immed to MD;				Y					Y	12/02/1996	12/02/1996	0	NA	PUB	PUB	APAP, Naprosyn, Nitroglycerin	NONE	angina	NONE~ ()~~~In patient	MI96184	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Lymphadenopathy; Neck pain; Pain	FLU3~PFIZER\WYETH~4968206~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~435964~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0093816	01/16/1997	VA	18.0	18		F	01/12/1997	pt c/o persistent deep muscular pain in deltoid 2wk;no neuromuscular abn on exam;+ tenderness;rx aleve x 5-7d;									Y	10/20/1996	10/20/1996	0	NONE	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Myalgia	FLU3~CONNAUGHT LABORATORIES~6F71195~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0093862	01/17/1997	IL	79.0	79		F	01/10/1997	12NOV96 unable to stand or walk;low (125) sodium, hands tingling, no reflex in both knees, GBS;				Y	Y		Y	Y	U	11/01/1996	11/12/1996	11	EMG (2)	PVT	PUB	ASA, Ibuprofen	NONE	coronary (4-way) bypass 7OCT96;diabetes	NA~ ()~~~In patient		1						1	Chills; Guillain-Barre syndrome; Hypokinesia; Hyponatraemia; Hyporeflexia; Paraesthesia	FLU3~PARKE-DAVIS~00675P~2~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation,Disabling	Influenza
0093863	01/17/1997	MI	54.0	54		F	11/12/1996	GBS onset days post vax sx numbness, throwing up, h/a, muscle weakness;			Y	Y	Y	32			U	10/23/1996	10/25/1996	2		OTH	OTH	vaccine given @ work free	NONE KNOWN	NONE KNOWN	~ ()~~~In patient		1						1	Guillain-Barre syndrome; Headache; Myasthenic syndrome; Paraesthesia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0093870	01/17/1997	PA	51.0	51		F	01/09/1997	swelling/tenderness lt shoulder & lt hand-redness @ site of inj lt shoulder;									Y	12/09/1996	12/13/1996	4		PVT	PVT	Atrovent, Lopid, Uniphyl	NONE	COPD, S/P renal cancer, CAD	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Pain	FLU3~CONNAUGHT LABORATORIES~6F71194~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0093878	01/17/1997	MN	67.0	67		M	01/09/1997	pt reported 2 days p/vax had rash, hives & numbness of both jaws & chin;reported to MD-who said to observe;									Y	10/09/1996	10/11/1996	2		PVT	UNK	Procardia, Testosterone	NONE	NONE	~ ()~~~In patient		1						1	Paraesthesia; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71239~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0093889	01/17/1997	WI	69.0	69		F	01/02/1997	pt called 2JAN97 states in OCT96 c/o n/v, h/a, weakness on & off x 2-3 wk;same sx returned in DEC96;pt was given flu vax 27SEP96, & felt fine till OCT96;									Y	09/27/1996	10/01/1996	4	NONE	PVT	PVT	Niacin, Synthroid	n/v, h/a OCT96	hypothyroidism, HTN, DJD, allerg to sulfa-ampicillin	~ ()~~~In patient		1						1	Asthenia; Headache; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71246~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0093892	01/17/1997	PA	74.0	73		M	01/09/1997	malaise/non-specific onset w/in 24hr of vax;resolved w/in a week;									Y	10/01/1996				PVT	PVT	Procan, fanoxin, coumadin	NONE	CAD, type II DM, hiatal hernia	~ ()~~~In patient		1						1	Malaise	FLU3~PARKE-DAVIS~00886P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0092128	01/21/1997	PA	34.0	34		F	11/07/1996	pt recv vax 30OCT96 & woke up 31OCT96 w/ red pruritic hives & sore joints rt arm;also c/o throat feels like it is closing;31OCT had multiple red macular (no urticarial) rash on buttocks, rt wrist & elbow;face swollen;tingling of chin;									Y	10/30/1996	10/31/1996	1		UNK	UNK	PPD by Connaught given 30OCT96 lot# 243113;		had flu vax in past w/no problems;has no known allergies;	~ ()~~~In patient		1						2	Arthralgia; Face oedema; Laryngospasm; Paraesthesia; Pruritus; Rash maculo-papular; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71266~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0092594	01/21/1997	OH	48.0	48		M	01/06/1997	pt recv vax & devel numbness & pain on the side of face on 30OCT96;dx 5NOV96 w/bell's palsy;medical remarkable for HTN;pt had rt facial pain w/o weakness in NOV96 & that the pain went away in one-two wk w/o sequelae;				Y					Y	10/01/1996	11/01/1996	31	NONE PROVIDED	PVT	OTH	Capozide	NONE	hx of HTN	~ ()~~~In patient	0010150960112	1						2	Facial palsy; Pain; Paraesthesia	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0093911	01/21/1997	ND	58.0	58		F	01/09/1997	onset of severe weakness, motor & sensory disturbances on11NOV96;clinical cause & diagnostic walk-up;consistent w/GBS;										10/30/1996	11/11/1996	12	CSF, nerve conduction studeis, physical exam;	PVT	PVT	NONE	NONE	NONE	NA~ ()~~~In patient	ND97001	1						1	Asthenia; Guillain-Barre syndrome; Hypokinesia; Hyporeflexia; Paraesthesia	FLU3~PFIZER\WYETH~4968163~1~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0093913	01/21/1997	NJ	73.0			M	01/20/1997	severe muscle achy in lower body, especially legs, trunk, & back;most painful @ noc;could not sleep lasted about a week;									Y	01/06/1997	01/07/1997	1	NONE	PUB	PUB	NONE	NONE		NONE~ ()~~~In patient	NJ9714	1						1	Back pain; Insomnia; Myalgia	FLU3~PARKE-DAVIS~409608~2~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0093923	01/21/1997	WA	46.0	46		F	11/12/1996	pt recv vax 8AM that evening 8PM felt induration 33mm @ site, joint pain (especially in hands, no dexterity at all) throughout body;also had extreme fatigue, malaise & nausea w/lower abd pain;had UTI but urine cult negative when saw MD;				Y					Y	11/05/1996	11/05/1996	0	NA	PUB	PVT	NONE	NONE	hayfever;hep A 1976;colitis;arthritis sx x 10yr;ezcema;	~ ()~~~In patient		1						1	Abdominal pain; Arthralgia; Asthenia; Hypokinesia; Injection site hypersensitivity; Injection site mass; Malaise; Nausea	FLU3~PFIZER\WYETH~4968265~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0093929	01/21/1997	WI	29.0	29		F	11/25/1996	28OCT95 day of vax deltoid swollen tender;29OCT96 lt shoulder ache x 1day;									Y	10/28/1996	10/28/1996	0	NONE	OTH	OTH	Birth control pills;Lomotil-genetic;Dicyclominc	NONE	irritable bowel	pt exp rxn in 1993 w/flu vax red sore arm-dime size;~ ()~~~In patient		1						1	Arthralgia; Injection site oedema; Injection site pain; Neck pain	FLU3~CONNAUGHT LABORATORIES~6F71307~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0093941	01/21/1997	KS	5.0	5		F	12/16/1996	pt devel welts all over but not the face;feet were so swollen that could not wear shoes;had red rash between welts;no fever;no resp distress;rash around mouth;welts move to face;									Y	11/12/1996	11/12/1996	0		PUB	PUB		constipation	up to age 3-4 was eval for pulmonary stenosis-grew out of this	NONE~ ()~~~In patient	KS96045	1						1	Oedema peripheral; Rash; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4968157~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0093943	01/21/1997	KS	48.0	48		M	12/19/1996	pt has had a migraine since 17DEC96;pt had a burning sensation on face 18DDEC96 which has resolved;pt also has chest pain;				Y					Y	12/17/1996	12/18/1996	1	Pulmonary studies EKG	PUB	PUB	Motrin	NONE	hiatal hernia-2yr ago	~ ()~~~In patient	KS96047	1						1	Chest pain; Migraine; Pain	FLU3~PFIZER\WYETH~4968192~6~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0093952	01/21/1997	IL	38.0			F	11/07/1996	pt had an adverse rxn of tongue swelling & pruritus of tongue d/t flu vax;											10/22/1996			UNK	UNK	asthma inhalers (names unk)			~ ()~~~In patient		1						1	Pruritus; Tongue disorder; Tongue oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0094003	01/22/1997	TX	60.0	60		F		severe flu w/aches/pains, fever, exhaustion, phlegm;zithromax;cleared color of phlegm;				Y					N	10/01/1996	12/30/1996	90		UNK	OTH		NONE		~ ()~~~In patient		1						1	Asthenia; Influenza; Myalgia; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0093967	01/23/1997	MA	45.0	45		F	01/06/1997	pt recv vax 29OCT96 & pt hosp 30DEC96 w/flu-like illness, transferred to another hosp 2JAN97 w/? GBS;					Y				U	10/29/1996	12/30/1996	62	not known	PUB	PUB	unk	NONE	mild mental retardation	~ ()~~~In patient	MA9634	1						1	Guillain-Barre syndrome; Influenza	FLU3~CONNAUGHT LABORATORIES~6F71226~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0093968	01/23/1997	MA	66.0	65		M	11/01/1996	no adverse event reported 25OCT96 pt expired-cardiac arrest;	Y	10/25/1996							N	10/24/1996	10/25/1996	1		PUB	PUB			HTN (as noted on death certificate);	~ ()~~~In patient	MA9632	1						1	Apnoea; Cardiac arrest	FLU3~CONNAUGHT LABORATORIES~6F71226~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0093969	01/23/1997	NY	63.0	63		F	01/16/1997	pt recv vax 17OCT96 & w/in 24 hr gen muscle ache,  fever up to 102;pt exp muscle pain & weakness & macular facial rash;adm to hosp secondary to poor swallowing & swallory eval-aspiration;					Y				N	10/17/1996	10/18/1996	1	EMG & muscle biopsy positive for dx of dermatomyositis;CPK 2202;sed rate 20;RF negative;ANA +1:2560;	PUB	PVT	NONE	NONE	inc cholesterol, no other;	NONE~ ()~~~In patient		1						1	Dermatomyositis; Dysphagia; Myalgia; Myasthenic syndrome; Pyrexia; Rash maculo-papular; Respiratory disorder; Aspartate aminotransferase increased; Dysphagia; Laboratory test abnormal; Lung disorder; Myasthenic syndrome; Pyrexia; Rash maculo-papular; Respiratory disorder	FLU3~CONNAUGHT LABORATORIES~6F71308~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71308~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0094009	01/23/1997	MA	55.0	55		F	12/03/1996	approx 2hr p/vax pt couldn't move rt arm, extremely painful w/movement, woke up all right;has been taking advil for approx q 6hr since vax;has not called or seen MD;									Y	11/14/1996	11/14/1996	0	NONE	PUB	PUB		NONE	allergies hay, dust, cats, sulfur	NONE~ ()~~~In patient	MA9633	1						1	Hypokinesia; Insomnia; Myalgia	FLU3~CONNAUGHT LABORATORIES~6F71226~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0094335	01/23/1997	UT	3.0	3		M		pt recv vax 16NOV96 & 26NOV96 pt exp 5 lesions & mild fever for 1/2 of 1 days;				Y					Y	11/16/1996	11/26/1996	10	No relevant data;	UNK	UNK					WAES96120072	1						1	Dermatitis bullous; Pyrexia	FLU3~PFIZER\WYETH~4958111~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|VARCEL~MERCK & CO. INC.~~UNK~~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0094011	01/24/1997	WI	46.0			F	01/10/1997	pt recv vax 31OCT96 & devel local erythema, pruritis, & hives;eyes became puffy & c/o tongue felt swelled;feeling of fullness in throat, had hoarseness;denied SOB & no audible wheezing detected;given epi;adm to ICU for observation;				Y	Y	5			Y	10/31/1996	10/31/1996	0		UNK	UNK			hx of GERD & asthma;	~ ()~~~In patient		1						1	Dysphonia; Face oedema; Injection site hypersensitivity; Pharyngitis; Pruritus; Tongue oedema	FLU3~PARKE-DAVIS~00476P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0094019	01/24/1997	FL	77.0	77		F	01/18/1997	nausea, temp elevated, extreme dizziness, totally incapacitated-transferred from ER to hosp for 11 days;therapy for 5wk following discharge from hosp;				Y	Y	11			Y	10/25/1996	10/25/1996	0	blood tests EKG, EEG, MIR-dx vestibular neuronitis;	PUB	UNK		NONE	Mitral valve prolapse	NONE~ ()~~~In patient		1						1	Dizziness; Hypokinesia; Nausea; Neuritis; Pyrexia; Vestibular disorder	FLU3~MEDEVA PHARMA, LTD.~E3086GE~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0094028	01/24/1997	MD				F		pt recv vax & devel an 1/8 inch, red, raised, itchy area @ the site of inj;15 min later pt became pale & exp inc itching, wheezing & lightheadedness;tx w/Epi & DPH;pt recovered;									Y					UNK	UNK			hx of asthma;	~ ()~~~In patient		1						1	Asthma; Condition aggravated; Dizziness; Injection site hypersensitivity; Injection site mass; Pallor; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4968144~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0094029	01/24/1997	NY	42.0	42		F	11/20/1996	pt recv vax 17OCT96 & 20OCT96 pt exp fever, nausea, chang in taste, malaise;seen 28OCT96;SGOT 348, SGPT 538 w/nl t. bili; & alk 0;negative hep A,B,C, monospot, EBVAB, CMVAb, toxo Ab;								Y		10/17/1996	10/17/1996	0	12NOV96 no arthralgia	UNK	UNK	NONE;		no smoking, no ETOH;negative hx renal/hepatitis disease;no allergies;	~ ()~~~In patient		1						1	Alanine aminotransferase increased; Aspartate aminotransferase increased; Dysgeusia; Malaise; Nausea; Pyrexia	FLU3~PFIZER\WYETH~4968205~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0094032	01/24/1997	MA	32.0	32		F		pt recv vax 22OCT @ 11AM woke up 23OCT 6AM & noticed 2 red welts on face;hive-like area quarter size, area dime size;3 red area on face;MD rx Claritin;				Y					Y	10/22/1996	10/23/1996	1		PUB	PVT		NONE		~ ()~~~In patient		1						1	Urticaria	FLU3~PFIZER\WYETH~4968170~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0094033	01/24/1997	MA	67.0	67		M	10/29/1996	26OCT96 started w/cold sx;27OCT96 felt worse, fever, cough;25OCT96 went to own MD started on amoxicillin;almost had pneumonia;1NOV95 r/c wife states pt much better; improved 29OCT96;				Y					Y	10/24/1996	10/26/1996	2		PUB	PVT		NONE	NONE	~ ()~~~In patient		1						1	Cough; Malaise; Pharyngitis; Pneumonia; Pyrexia; Rhinitis	FLU3~PFIZER\WYETH~4968136~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0094034	01/24/1997	MA	34.0	34		F	11/06/1996	pt recv vax 31OCT on 5NOV woke w/flu like sx, dizziness, h/a, nausea & fever of 100.6;states this was first time recv flu vax-pt had terrible flu last winter;									Y	10/31/1996	11/05/1996	5		PUB	UNK		NONE		~ ()~~~In patient		1						1	Dizziness; Headache; Influenza; Nausea; Pyrexia	FLU3~PFIZER\WYETH~4968170~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0094035	01/24/1997	MA	49.0	49		F	10/31/1996	lightheaded, achy felt lousy-almost immed home ill from work 25OCT96 afeb;soreness @ inj site lt arm x 1wk;									Y	10/23/1996	10/25/1996	2		PUB	PVT	NONE	NONE	asthma	~ ()~~~In patient		1						1	Dizziness; Injection site pain; Malaise; Myalgia	FLU3~PFIZER\WYETH~496817D~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0094489	01/24/1997	WI	42.0	42		M	01/06/1997	pt recv vax & exp tonic-clonic sz & was hosp;@ the date of this report, pt cont to exp sz;the reporter does not believe this event was vaccine-related;					Y	15			Y	12/03/1996	12/31/1996	28	MRI x3 - normal; LP - 30 cells (mostly lymphycytes) no protein, no glucose; EEG diffuse encephalopathy	PVT	PVT	Sudafed;unspecified ATB	none	URI in mid-December	~ ()~~~In patient	897008023L	1						1	Coma; Convulsion; Encephalopathy; Neuropathy	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0094041	01/27/1997	NJ	54.0	54		F	01/06/1997	pt recv vax & approx 1mo p/vax devel petechiae;several days later devel a large hematoma on rt cheek;pt adm to hosp & on adm platelet count was found to be 7000;pt currently being treated w/steroids & gamma globulin;					Y				Y	11/30/1996	01/02/1997	33		PVT	OTH	Mevacor;Unspecified antihypertensive	NONE	HTN, hypercholesterolemia;	~ ()~~~In patient	897009008L	1						1	Haemorrhage; Petechiae; Thrombocytopenia	FLU3~PFIZER\WYETH~~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0094042	01/27/1997	WA	37.0	37		M	12/30/1996	pt recv vax 15OCT96 & devel a rash on neck, face, chest, & hands on 1NOV96; exp fatigue & muscle pain;CPK was elevated & was treated IV pred;hosp is presumed although not documented;									U	10/15/1996	10/22/1996	7	4NOV96 CPK 7,000;7NOV96 16,000;12NOV96 7,000;8NOV96 CBC w diff nl;EBV IgG 1:640;EBV IgM <1:10;	PVT	PVT	Cimetidine;Advil	NONE	seasonal rhinitis;	~ ()~~~In patient	897010010L	1						1	Asthenia; Blood creatine phosphokinase increased; Myalgia; Rash; Influenza	FLU3~PFIZER\WYETH~4968265~3~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968265~3~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0094042	01/27/1997	WA	37.0	37		M	12/30/1996	pt exp flu-like sx p/flu vax;					Y				U	10/15/1996	10/22/1996	7	4NOV96 CPK 7,000;7NOV96 16,000;12NOV96 7,000;CBC w/diff 8NOV96 nl;EBV IgG 1:640;EBV IgM <1:10;muscle biopsy results no provided;	PVT	PVT	Cimetidine;advil	NONE	seasonal rhinitis	~ ()~~~In patient	897010010L	1						2	Asthenia; Blood creatine phosphokinase increased; Myalgia; Rash; Influenza	FLU3~PFIZER\WYETH~4968265~3~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968265~3~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0094043	01/27/1997	OK				F	12/16/1996	pt recv vax & devel pain & GBS;hosp is presumed, although not documented;this is a serious, labelled event;					Y				U	11/01/1994				OTH	OTH	UNK	UNK		~ ()~~~In patient	897009009L	1						1	Guillain-Barre syndrome; Pain	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0094044	01/27/1997	KS				M	12/16/1996	pt recv vax 24SEP94 & allegedly dx w/GBS on 19OCT94;as a result of GBS pt suffered pain & permanent disability;hosp is presumed, although not documented;this is a serious, labelled event;					Y			Y	N	09/24/1994	10/19/1994	25		OTH	OTH	UNK	UNK		~ ()~~~In patient	897009012L	1						1	Guillain-Barre syndrome; Pain	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0094045	01/27/1997	OR				M	12/20/1996	pt recv vax & w/in 35 days of vax pt devel nausea, elevated body temp, backache, weakness in the lower extremities, & diff urinating;dx of transverse myelitis was allegedly made on 13DEC88;pt exp pain & permanent paraplegia;				Y	Y		Y	Y	N	10/12/1988	11/17/1988	36		OTH	OTH	UNK	UNK		~ ()~~~In patient	897009014L	1						1	Back pain; Dysuria; Myasthenic syndrome; Myelitis; Nausea; Pain; Paraplegia; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0094047	01/27/1997	NY	56.0	56		M	01/20/1997	pt recv vax 5JAN97 & on 10JAN97 pt c/o heavy feeling in legs;11NOV97 c/o bilat weakness in the lower extremities & ascending paralysis;13JAN97 was hosp for GBS;					Y				Y	12/30/1996	01/10/1997	11		PVT	PVT				~ ()~~~In patient	CO7066	1						1	Asthenia; CSF test abnormal; Depression; Guillain-Barre syndrome; Myasthenic syndrome; Neuropathy; Paralysis; CSF test abnormal; Guillain-Barre syndrome; Neuropathy; Guillain-Barre syndrome; Neuropathy; Paralysis	FLU3~CONNAUGHT LABORATORIES~6F71277~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71277~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Hospitalisation	Influenza
0094417	01/27/1997	NC	47.0	47		F	11/25/1996	pt called clinic 25OCT96 w/ c/o numbness/heavy feeling of same arm that inj given;20NOV96 c/o fever all day & more aware & tingling of lt extremity, more w/fingers;arms feels heavy-fingers numb;plans to see MD today; 26Nov96 tingl lt arm;									Y	11/15/1996	11/20/1996	5	NONE	PUB	PUB	NONE	NONE	elevated cholesterol, overweight, CA cervix 1978;	NONE~ ()~~~In patient	NC97007	1						1	Asthenia; Paraesthesia	FLU3~PARKE-DAVIS~00376P~2~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094427	01/27/1997	MN	37.0	37		M	11/09/1996	body aches, inc temp 103.0, nausea & tightness in chest;felt dreadful for approx 24hr;body aches cont for 48hr;have had rxn to flu shot in the past but, not as severe & not every year;									Y	10/25/1996	10/25/1996	0	NONE	OTH	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						1	Chest pain; Malaise; Myalgia; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71221~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0094437	01/28/1997	MA	57.0	57		M	01/16/1997	flu sx 16NOV-pain, legs following wk-progressed diff breathing-went to hosp dx w/ GBS 26NOV;					Y	11			Y	10/24/1996	11/26/1996	33		PUB	PUB		NONE		~ ()~~~In patient		1						1	Dyspnoea; Guillain-Barre syndrome; Influenza; Myasthenic syndrome; Pain	FLU3~CONNAUGHT LABORATORIES~6F71226~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0094438	01/28/1997	PA	50.0	50		M	01/21/1997	aching, numbness, weakness tightness in chest, labored breathing, 23 days p/vax;hospitalized ICU-8 days requiring feeding tube;hosp 25 days walking w/aid of cain & receiving physiotherapy;			Y	Y	Y	25			N	10/23/1996	11/15/1996	23	neurological testing-abn;brain scan;	OTH	OTH	asulfadine	NONE	Crohn's disease dust/molds allergies;	~ ()~~~In patient		1						1	Anorexia; Chest pain; Dyspnoea; Hypokinesia; Laboratory test abnormal; Myalgia; Neuropathy; Paraesthesia	FLU3~PFIZER\WYETH~4968198~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0094440	01/28/1997	MD	67.0	67		F	12/09/1996	9DEC96 pt stated gets a red ring approx the size of 1/2 of a pencil eraser which itches @ site of flu shot;It had a small scab @ the center;It itches every day though;not cont just @ various times throughout the day;site sore & itchy;									Y	10/28/1996	11/12/1996	15	NONE	PUB	PUB		NONE	admits to allergy to some kinds of bandaids;bandaid w/flu shot;	~ ()~~~In patient	MD97009	1						1	Injection site hypersensitivity; Pruritus	FLU3~MEDEVA PHARMA, LTD.~E3026GB~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0094461	01/28/1997	CO	61.0			F	12/27/1996	2 days post vax pt broke out w/shingles on rt shoulder; site of vax very painful was afraid to take shot this year;husband did & 2 days later got the shingles again on waist;				Y					U					OTH	UNK				NONE~ ()~~~In patient		1						1	Herpes zoster; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0094464	01/28/1997	MN	42.0	42		F	01/09/1997	pt recv vax 240PM 31DEC96 @ 7:42 1JAN97 vomiting, diarrhea & cramping cont;taking APAP;t99.4, body aches, chills, nausea;cont through 6JAN;h/a through 5JAN;									U	12/31/1996	01/01/1997	1	NONE	PUB	PUB	vitamins-prenatal	NONE	allergies-thimerosol, PCN, erythromycin;gastritis	pt recv vax lightheaded didn't feel well @ 35 yr old w/flu;pt sibling got sick;~ ()~~~In patient	MN96066	1						1	Abdominal pain; Diarrhoea; Headache; Myalgia; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~4968167~7+~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0094469	01/28/1997	MN	28.0	28		M	01/17/1997	pt recv vax & was later hosp w/GBS;MD suggested it may be r/t flu vax given 14NOV96;					Y				U	11/14/1996				OTH	UNK		NONE	NONE	~ ()~~~In patient	MN96065	1						1	Guillain-Barre syndrome	FLU3~PFIZER\WYETH~4968144~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0094473	01/29/1997	PA	50.0			F	01/26/1997	temp					Y				Y		12/21/1996		NONE	OTH	OTH	NONE	NONE	NKA	NA~ ()~~~In patient		1						1	Drug ineffective; Pyrexia	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0094493	01/29/1997	PA	94.0	94		F	01/26/1997	cough, congested;									Y	10/21/1996			NONE	OTH	OTH	NONE	NONE		NA~ ()~~~In patient		1						1	Cough; Rhinitis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094494	01/29/1997	PA	72.0	72		F	01/26/1997	cough									Y	10/21/1996	12/19/1996	59	NONE	OTH	UNK		NONE	NONE	NONE~ ()~~~In patient		1						1	Cough	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094495	01/29/1997	PA	85.0	85		F	01/26/1997	cough, congested;									Y	10/14/1996	12/20/1996	67	NONE	OTH	OTH			ASA, Ibuprofen	~ ()~~~In patient		1						1	Cough; Rhinitis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094496	01/29/1997	PA	75.0	75		F	01/26/1997	cough;									Y	10/14/1996	12/21/1996	68	NONE	OTH	OTH			cipiofloxacin, keflex	~ ()~~~In patient		1						1	Cough	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094497	01/29/1997	PA	75.0			F	01/26/1997	cough									Y		12/20/1996		NONE	OTH	UNK			NKA	~ ()~~~In patient		1						1	Cough	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094498	01/29/1997	PA	74.0	74		F	01/26/1997	cough, congested;									Y	10/14/1996	12/21/1996	68	NONE	OTH	OTH	NONE	NONE	allergy PCN	NA~ ()~~~In patient		1						1	Cough; Rhinitis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094499	01/29/1997	PA	62.0	62		F	01/26/1997	temp, cough, congested;									Y	10/14/1996			NONE	OTH	OTH	NONE	NONE	NKA	NA~ ()~~~In patient		1						1	Cough; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094500	01/29/1997	PA	88.0	88		M	01/26/1997	cough, congested;									Y	10/14/1996			NONE	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Cough; Rhinitis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094501	01/29/1997	PA	91.0	91		M	01/26/1997	cough, congested;									Y	10/14/1996			NONE	OTH	OTH	NA	NONE	NKA	NA~ ()~~~In patient		1						1	Cough; Rhinitis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094502	01/29/1997	PA	93.0	93		F	01/26/1997	cough, congested;									Y	10/14/1996			NONE	OTH	OTH	NA	NONE	ASA	NA~ ()~~~In patient		1						1	Cough; Rhinitis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094503	01/29/1997	PA	96.0	96		F	01/26/1997	cough, congested;									Y	10/15/1996			NONE	OTH	OTH	NA	NONE	NKA	NA~ ()~~~In patient		1						1	Cough; Rhinitis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094504	01/29/1997	PA	88.0			F	01/26/1997	cough, congested;									Y				NONE	OTH	OTH	NA		codeine, feldane, NSAID, ASA			1						1	Cough; Rhinitis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094505	01/29/1997	PA	86.0	86		F	01/26/1997	cough, congested									Y	10/14/1996			NONE	OTH	OTH	NONE	NA	NONE	NA~ ()~~~In patient		1						1	Cough; Rhinitis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094506	01/29/1997	PA	80.0	80		M	01/26/1997	congested, lethargic, not eating;	Y								N	10/03/1996			NONE	OTH	OTH		NONE	allergy PCN	NONE~ ()~~~In patient		1						1	Anorexia; Rhinitis; Somnolence	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0094507	01/29/1997	PA	88.0	88		F	01/23/1997	cough, runny;									Y	10/14/1996	12/14/1996	61	NONE	UNK	UNK		NONE		~ ()~~~In patient		1						1	Cough; Rhinitis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094508	01/29/1997	PA	92.0	92		F	01/23/1997	coughing, chest congestion;									Y	10/13/1996	12/15/1996	63	NA	OTH	UNK		NONE	NONE	~ ()~~~In patient		1						1	Cough; Lung disorder	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094509	01/29/1997	PA	83.0	82		F	01/23/1997	coughing, chest congestion;									Y	10/14/1996	12/15/1996	62	NONE	UNK	UNK				~ ()~~~In patient		1						1	Cough; Lung disorder	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094510	01/29/1997	PA	84.0	84		M	01/22/1997	cough									Y	10/14/1996			NONE	OTH	UNK		NONE	allergy PCN	NONE~ ()~~~In patient		1						1	Cough	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094511	01/29/1997	PA	88.0	88		F	01/16/1997	cough, congestion;									Y	10/14/1996	12/20/1996	67		OTH	OTH	NONE	NONE	GE REFLUX, Peptic ulcer disease	NONE~ ()~~~In patient		1						1	Cough; Rhinitis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094512	01/29/1997	PA	93.0	93		F	01/22/1997	cough, congestion;									Y	10/14/1996	12/09/1996	56		OTH	OTH	NONE	NONE	ASCVD	~ ()~~~In patient		1						1	Cough; Rhinitis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094513	01/29/1997	PA	70.0	70		M	01/14/1997	cough, congestion, fever;									Y	10/14/1996	12/19/1996	66		OTH	OTH	NONE	NONE	allergy ASA;colon cancer w/mets, bladder cancer, bone cancer	NONE~ ()~~~In patient		1						1	Cough; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094514	01/29/1997	PA	91.0	91		F	01/16/1997	cough, fever, congestion;									Y	10/07/1996	12/20/1996	74		PVT	UNK		NONE	rt fx femur, hypothyroidism, anxiety	NONE~ ()~~~In patient		1						1	Cough; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094515	01/29/1997	PA	85.0	85		F	01/14/1997	cough, congestion;									Y	10/03/1996	12/19/1996	77		OTH	OTH	NONE	NONE	NKA	NONE~ ()~~~In patient		1						1	Cough; Rhinitis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094516	01/29/1997	PA	97.0	97		F	01/23/1997	cough inc, sneezing & chest congestion;									Y	10/15/1996	12/14/1996	60	NONE	OTH	UNK	NONE		NONE	NA~ ()~~~In patient		1						1	Cough; Lung disorder; Rhinitis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094517	01/29/1997	PA	92.0	92		F	01/26/1997	cough, congestion, lethargic									Y	10/14/1996			NONE	OTH	OTH			NKA	~ ()~~~In patient		1						1	Cough; Rhinitis; Somnolence	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094518	01/29/1997	PA	93.0	92		F	01/26/1997	cough, congested;									Y	10/14/1996			NONE	OTH	OTH			ASA	~ ()~~~In patient		1						1	Cough; Rhinitis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094519	01/29/1997	PA	90.0	90		F	01/26/1997	cough, congested;									Y	10/14/1996			NONE	OTH	OTH			ASA	~ ()~~~In patient		1						1	Cough; Rhinitis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094520	01/29/1997	PA	92.0	91		F	01/26/1997	lethargic, cough, congested;									U	10/21/1996			NONE	OTH	OTH	NA		NONE	NA~ ()~~~In patient		1						1	Cough; Rhinitis; Somnolence	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094531	01/29/1997	AZ				U		4 pt describe severe achiness & malaise beginning 2-3 days p/vax;sx lasting 2 wk;no other sx;										10/01/1996	10/03/1996	2		UNK	UNK		NONE	NONE	~ ()~~~In patient		1						1	Malaise; Myalgia	FLU3~PFIZER\WYETH~4968203~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0094532	01/29/1997	CT	43.0			F	11/06/1996	striking local erythema area, induration @ site of flu vax;											10/27/1996		NONE	UNK	UNK	NONE			~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~6F71286~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0094536	01/29/1997	MD	38.0	37		F	12/11/1996	pt began exp shaky feeling, nausea, abd pain, lower back pain;pt seen by MD the next day & had upper resp sx: e.g. runny nose, sneezing, cough, congestion;back pain dx as pulled muscle;17DEC96 pt has lingering cold sx;				Y					Y	12/11/1996	12/11/1996	0	NONE	PUB	PUB	spiralactinate	NONE	NONE	~ ()~~~In patient	MD96051	1						1	Abdominal pain; Back pain; Cough; Nausea; Pharyngitis; Respiratory disorder; Rhinitis; Tremor	FLU3~MEDEVA PHARMA, LTD.~E3106GB~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0094537	01/29/1997	MD	58.0	58		F	11/19/1996	14NOV96 pt began sx of achiness, sore throat, fever, chills, red blotchy itchy rash;also had sx of asthma (pre-existing condition);seen by MD 15NOV96 who felt this was a rxn to flu vax;				Y					Y	11/12/1996	11/14/1996	2	NONE	PUB	PUB	albuterol;Theophyllin	NONE	asthma	NONE~ ()~~~In patient	MD96050	1						1	Asthma; Chills; Condition aggravated; Myalgia; Pharyngitis; Pruritus; Pyrexia; Rash maculo-papular	FLU3~MEDEVA PHARMA, LTD.~E386GD~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0094538	01/29/1997	MD	37.0	37		F	10/20/1996	redness, warmth, swelling itching over rt deltoid extending 3cm from inject site;									Y	10/10/1996	10/10/1996	0		OTH	OTH	Darvocet PRN	NONE	NONE	~ ()~~~In patient	MD96046	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3086GG~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0094539	01/29/1997	MD	52.0	52		M	10/20/1996	lt deltoid red, warm to touch, swollen & itching;									Y	10/10/1996	10/10/1996	0		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	MD96042	1						1	Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Pruritus; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3086GG~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0094542	01/29/1997	NV	52.0	52		F	08/12/1996	both arms contracted against chest-fingers not aligned;no control over movement;unable to ambulate or perform personal hygiene tasks;paresthesia all extremities;muscle pain;h/a,myalgia,cephalgia,blurred vision;Heglund's deformities;				Y					N	10/25/1995	12/07/1995	43		PVT	PVT	Estrogen;Thyroid?			~ ()~~~In patient		1						1	Amblyopia; Headache; Hypokinesia; Hyporeflexia; Myalgia; Paraesthesia; Skin hypertrophy; Tendon disorder	FLU3~PARKE-DAVIS~00785P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~1076B~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~5F71086~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0095007	01/29/1997	AZ				U		all 4 pt describe severe achiness & malaise beginning 2-3 days p/vax;sx lasting 2 wk;no other sx;										10/01/1996	10/01/1996	0	NONE	UNK	UNK			NONE	~ ()~~~In patient		1						1	Malaise; Myalgia	FLU3~PFIZER\WYETH~4968203~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095008	01/29/1997	AZ				U		all 4 pt describe severe achiness & malaise beginning 2-3 days p/vax;sx lasting 2 wk;no other sx;										10/01/1996	10/01/1996	0	NONE	UNK	UNK			NONE	~ ()~~~In patient		1						1	Malaise; Myalgia	FLU3~PFIZER\WYETH~4968203~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095009	01/29/1997	AZ				U		all 4 patients described severe achiness & malaise beginning 2-3 days p/vax;sx lasting 2 wk;no other sx;										10/01/1996	10/01/1996	0	NONE	UNK	UNK			NONE	~ ()~~~In patient		1						1	Malaise; Myalgia	FLU3~PFIZER\WYETH~4968203~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0094478	01/30/1997	TX	51.0	51		M	12/04/1996	pt dx w/GBS 2-3wk p/vax;12NOV96 middle back pain;severe h/a;15NOV tingling & numbness in hands & arms;inc pain w/elevated BP (reading taken @ home);16NOV inc back pain, inc h/a;went to ER dx w/back sprain;18NOV facial paralysis;adm to hosp			Y	Y	Y	5	Y		N	10/31/1996	11/12/1996	12	Protein in CSF	PVT	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	TX96199	1						1	Back pain; CSF test abnormal; Cardiovascular disorder; Facial palsy; Guillain-Barre syndrome; Hypertension; Myasthenic syndrome; Paraesthesia	FLU3~PARKE-DAVIS~01286P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation	Influenza
0094482	01/30/1997	CA	51.0	51		M	01/09/1997	started 25NOV96 by numbness in one finger progressing to tips of all fingers, anus, penis, & had a lump on throat;			Y	Y	Y	17	Y		Y	11/04/1996	11/25/1996	21	Nerve conduction study;Electromyelogram	OTH	OTH	ASA, Digoxin	NONE	atrial flutter & fibrillation	~ ()~~~In patient		1						1	Guillain-Barre syndrome; Paraesthesia; Skin nodule	FLU3~CONNAUGHT LABORATORIES~617238~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0094553	01/30/1997	CA	36.0	36		F	11/12/1996	palpitations/tachycardia sent to ER by MD who ordered DPH @ office;ER MD examined-pt OK (p/ 1 1/2hr);				Y					Y	11/06/1996	11/06/1996	0	simple exam-no blood work;	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Palpitations; Tachycardia	FLU3~CONNAUGHT LABORATORIES~6F71212~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0094563	01/30/1997	TX	45.0	44		M	11/01/1996	pt c/o red streak from rt shoulder up over collar bone 7 one across chest 8-10 long;denies pain in inj site;no redness in inj site;pt applied hot & cold compresses;took ATB had @ home;sx gone w/in 24hr;									Y	10/28/1996	10/29/1996	1	NONE	OTH	PUB	NONE	NONE		~ ()~~~In patient	TX97001	1						1	Skin striae	FLU3~CONNAUGHT LABORATORIES~6F71275~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~390969~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0094564	01/30/1997	TX	33.0	33		F	12/12/1996	pt states pt recv flu shot on rt arm & pneumococcal in lt arm;lt arm became swollen, red & painful from the elbow to the shoulder & could not move it w/o pain on Thursday 5DEC96;went to ER;MD stated was infect from the inj;				Y					Y	12/04/1996	12/05/1996	1	NONE	OTH	PUB			asthma	~ ()~~~In patient	TX97002	1						1	Hypokinesia; Infection; Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~6F71275~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0332D~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0094566	01/30/1997	TX	38.0	38		F	12/16/1996	swollen lymph glands under rt arm;had resp congestion that lasted 6hr;has hx of dilated kidney;exp serve burning bilat in kidney area;lasted 4hr low grade fever for 48hr;									Y	12/13/1996	12/13/1996	0		PUB	PUB	PPD by Connaught lot# 243022 given 13DEC96;	NONE	dilated rt kidney	NONE~ ()~~~In patient	TX97004	1						1	Condition aggravated; Lung disorder; Lymphadenopathy; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71275~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0332D~2~SC~RA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~6F81202~4~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0094569	01/30/1997	TX	44.0	44		F	11/12/1996	3:00 rt arm swollen to fingertips;9NOV arm discolored, painful;cannot move easily;pt tired-10NOV situation starting to resolve;									Y	11/08/1996	11/08/1996	0		UNK	UNK				~ ()~~~In patient	TX96178	1						1	Asthenia; Hypokinesia; Oedema peripheral; Pain; Skin discolouration	FLU3~CONNAUGHT LABORATORIES~6F71275~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0332D~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0094571	01/30/1997	TX	63.0	63		F	11/01/1996	pt recv vax 24OCT96 reddened area  w/o rash to upper lt arm;warm & soft to palpation;c/o tenderness-no swelling;appt w/MD 20NOV96;				Y						10/24/1996	10/25/1996	1	NONE	PUB	OTH	Insulin;Zestril;APAP	HTN-diabetes-arthritis	NONE	NA~ ()~~~In patient	TX96180	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71275~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~6F81189~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0094572	01/30/1997	TX	48.0	48		F	10/31/1996	redness, tenderness, bump per site, fever @ site;seen in ER;				Y					U	10/25/1996	10/26/1996	1		PUB	PUB		NONE	?allergies (inj);	~ ()~~~In patient	TX96181	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~6F71275~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~394961~UNK~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0094575	01/30/1997	TX	36.0	36		F	10/16/1996	local rxn-rt deltoid red, edematous, warm to touch approx 50 by 30mm in diameter;										10/15/1996	10/16/1996	1	NONE	PUB	PVT		NONE	HTN	~ ()~~~In patient	TX96167	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4968203~4~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0094583	01/30/1997	TX	40.0	40		F	10/14/1996	pt recv vax 10OCT96  & 14OCT96 rxn reported;11OCT96 pt devel hives-no diff breathing etc;to MD on 12OCT96 for hives given Medrol & DPH-resolved;				Y					Y	10/10/1996	10/11/1996	1		OTH	PUB	Calan SR	NONE	NONE-BP	~ ()~~~In patient	TX96158	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71194~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0094588	01/30/1997	TX	43.0	43		F	10/17/1996	pt recv vax 930AM; no contraindication noted;pt returned to clinic approx 3PM-eyes were red, swollen & watery;pt sounded congested AEB sniffling;face & arms had sl red, flushed appearance;c/o throating hurting;hard to swallow; & chest				Y					Y	10/16/1996	10/16/1996	0	no lab tests performed;	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	TX96163	1						1	Chest pain; Conjunctivitis; Dysphagia; Face oedema; Lacrimal disorder; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~6F71275~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0094599	01/30/1997	TX	45.0	45		F	10/30/1996	pain in arm, fever, body ache;same feeling as w/the flu;									Y	10/15/1996	10/15/1996	0	NONE	PUB	OTH	allergy shots	NONE	tetanus vaccine-fermintation in alcohol-TB test	NA~ ()~~~In patient	TX96190	1						1	Influenza; Myalgia; Pain; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E3106HB~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0094600	01/30/1997	TX	68.0	68		F	11/14/1996	pt recv vax 14NOV96 230PM & approx 12-13 hr p/vax pt devel swelling of the face, neck & hands w/itchy rash;DPH was taken to relieve sx;approx 24hr later sx got worse & a visit to hosp ER was necessary;shot given for itching;				Y					Y	11/12/1996	11/13/1996	1	NONE	PUB	PUB	BP, heart, fld, muscle relaxant	NONE	NONE	NONE~ ()~~~In patient	TX96191	1						1	Face oedema; Oedema; Oedema peripheral; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~6F71275~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0094605	01/30/1997	TN	60.0	60		F	01/16/1997	pt recv vax & devel extreme pain in arm p/vax 4OCT96;pt could not use arm d/t pain;took anti-inflammatories which did not help;x-ray of arm showed biceps inflamed;pt MD gave cortisone inj which relieved pain, but did not help mobility				Y					N	10/04/1996	10/04/1996	0	x-ray of arm: inflamed bicep	PVT	OTH	Thyroid, estorgen nos, provera	NONE	hx of polio & exp dec mobility in body p/recv swine flu shot @ age 40;	pt exp polio & dec mobility in body p/flu shot @ age 40~ ()~~~In patient	001015097003900	1						1	Arthritis; Condition aggravated; Hypokinesia; Myalgia; Pain; Tendon disorder	FLU3~PARKE-DAVIS~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0094611	01/31/1997	NJ	81.0			M	01/29/1997	exp weakness & collapsed 2 days p/vax;pt adm to hosp & found to have E coli in blood;devel thrush & esophagitis & diff swallowing & a esophageal ulcer was suspected;HGB dec from 11.8 to 8.0;pt was losing blood;pt devel resp failure;BP	Y	01/17/1997			Y	56			U	11/21/1996	11/23/1996	2		OTH	OTH	Cytotec/misoprostol;Ibuprofen, ATB, heparin		rheumatoid arthritis:ongoing hx of rheumatoid arthritis for 2-3 yr;pt had hip fracture;	~ ()~~~In patient	MPI97036	1						1	Asthenia; Dysphagia; Haemorrhage; Hypoxia; Oesophageal ulcer; Oesophagitis; Sepsis; Shock	FLU3~MEDEVA PHARMA, LTD.~E10660~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0094638	01/31/1997	MN	49.0	49		F		lt arm sore;swelling x 4-6wk;										10/16/1996	10/16/1996	0		PVT	UNK				~ ()~~~In patient		1						1	Oedema peripheral; Pain	FLU3~CONNAUGHT LABORATORIES~6F71316~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0092925	02/03/1997	IA	60.0	60		F	10/30/1996	pt recv vax & w/in 10min felt funny;by 245PM unable to swallow, diaphoretic, diff breathing, BP 190/110; pt recv epi & DPH a/emergency transport to hosp;@ hosp recv more DPH & steroids & adm to r/o  rxn triggering MI;			Y		Y	1				10/24/1996	10/24/1996	0	chem profile, arterial gases;cardiac enzymes;multiply EKG;CXR 2 views over 24OCT96 & 25OCT96 hosp;	UNK	UNK	NONE		NKA	~ ()~~~In patient		1						2	Dysphagia; Dyspnoea; Hyperhidrosis; Hypertension; Personality disorder	FLU3~CONNAUGHT LABORATORIES~6F71316~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0094613	02/03/1997	VA	72.0	72		F	01/22/1997	dx w/acute transverse myelitis-hosp from 9JAN97-17JAN97 then transported to a rehab facility w/lower extremities paraplegic & numbness up to T4/t% level;					Y	8		Y	N	11/25/1996	01/06/1997	42	CSF w/elevated protein otherwise negative x/for few WACS;MRI w/ inc signal for T5-T10;	PUB	PUB	Cordizen, Insulin, Trental	diabetes, HTN, periph vasc disease	diabetes, HTN, peripheral vascular disease	NONE~ ()~~~In patient	VA97036	1						1	CSF test abnormal; Myelitis; Paraesthesia; Paraplegia	FLU3~PFIZER\WYETH~4968170~7+~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0094730	02/03/1997	WI	32.0	32		F		hot red circle around flu shot area, warm to touch-swollen-ached for 1 1/2hr									Y	12/04/1996	12/06/1996	2	NONE	PVT	PVT	Cyclobonzaprine, Orthocept +28, Prilosec, Zoloft	NONE	Sulfa	pt exp vomiting OCT95 @ 31 w/flu vax dose 1~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Myalgia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71307~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0094731	02/03/1997	OH	61.0	61		F	01/28/1997	diffuse rash-Medrol dose pak;				Y					Y	11/18/1996	11/20/1996	2	NA	PVT	PVT	Paxil	stiff neck	depression	~ ()~~~In patient		1						1	Rash	FLU3~CONNAUGHT LABORATORIES~6F71293~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0094732	02/03/1997	OH	23.0	23		F	01/28/1997	tender lt shoulder, no rash-DPH				Y					Y	11/06/1996	11/13/1996	7	NA	PVT	PVT	Claritan D	DM, allergies	diabetic, multiple allergies	~ ()~~~In patient		1						1	Pain	FLU3~CONNAUGHT LABORATORIES~6F71293~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~438671~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0094745	02/03/1997	MO	47.0	47		F	12/03/1996	pain & swelling under arm;no rxn @ inj site;										11/08/1996	11/08/1996	0	ultrasound of axillary area;	UNK	UNK				~ ()~~~In patient		1						1	Lymphadenopathy; Pain	FLU3~PFIZER\WYETH~4968168~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0093969	02/04/1997	NY	63.0	63		F	01/31/1997	w/in 24hr of vax pt exp gen muscle weakness & t102;pt had gen muscle weakness, & a macular facial rash;labs CPM 2202, SGOT 90, sed rate 20, RF negative, ARA +1:2560, 12-696;started on pred;adm to hosp d/t poor swallowing & aspiration					Y				U	10/17/1996	10/18/1996	1		PUB	PVT	NONE			~ ()~~~In patient	CO7070	1						2	Dermatomyositis; Dysphagia; Myalgia; Myasthenic syndrome; Pyrexia; Rash maculo-papular; Respiratory disorder; Aspartate aminotransferase increased; Dysphagia; Laboratory test abnormal; Lung disorder; Myasthenic syndrome; Pyrexia; Rash maculo-papular; Respiratory disorder	FLU3~CONNAUGHT LABORATORIES~6F71308~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71308~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0094047	02/04/1997	NY	56.0	56		M	01/31/1997	pt recv vax & devel GBS, neuro exam & CSF results were reported as relevant diagnostic/lab results;pt is undergoing plasmaphoresis tx;					Y				Y	12/30/1996			CSF; neurological exam	PVT	PVT				~ ()~~~In patient	CO7073	1						2	Asthenia; CSF test abnormal; Depression; Guillain-Barre syndrome; Myasthenic syndrome; Neuropathy; Paralysis; CSF test abnormal; Guillain-Barre syndrome; Neuropathy; Guillain-Barre syndrome; Neuropathy; Paralysis	FLU3~CONNAUGHT LABORATORIES~6F71277~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71277~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Hospitalisation	Influenza
0094652	02/05/1997	AZ	49.0	49		F		devel GBS which was dx on 6DEC96;lost all muscle control in arms & legs;was hosp on 15JAN97;spent 3 days in the hosp;returned home on 24JAN97;in the process of receiving physical therapy @ this time;				Y	Y	7			N	09/27/1996	11/07/1996	41	spinal tap, EMG, MVD	OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Guillain-Barre syndrome; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~6F71238~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~436121~UNK~~~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0094653	02/05/1997	PA	41.0	41		M	01/14/1997	26OCT96 exp tingling in toes & fingers as well as facial swelling;adm to hosp 1NOV96 dx GBS;hospitalized & treated w/plasmapheresis;pt has chronic inflammatory debilitating polyneuropathy (presumed to be chronic inflammatory demyelinating)				Y	Y	11			N	10/09/1996	10/26/1996	17		PVT	PVT	NONE	NONE		~ ()~~~In patient	897016004L	1						1	Face oedema; Guillain-Barre syndrome; Neuropathy; Paraesthesia; CSF test abnormal; Guillain-Barre syndrome	FLU3~PARKE-DAVIS~~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00276P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Hospitalisation	Influenza
0094654	02/05/1997	AL	27.0	27		F	01/16/1997	extreme pain in arms & leg muscles appears @ 1 wk p/vax;also devel reddish purple rash on chest, shoulders, nose, cheeks & around eyes;dx w/dermatomyositis & currently being treated w/pred under the care of MD;				Y	Y	1				10/17/1996	10/24/1996	7		OTH	PVT	Ortho tri-cyclen	NONE	NONE	~ ()~~~In patient		1						1	Dermatomyositis; Myalgia; Purpura	FLU3~MEDEVA PHARMA, LTD.~E3066GC~1~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0094813	02/05/1997	MI	40.0	40		F	01/14/1997	pt woke up 11PM & had a hard time breathing;felt tingling in spine;weird, scary sensation;uncontrollable shaking;lasted for about 1/2hr;pt husband took pt to ER;				Y					Y	10/30/1996	10/30/1996	0		PUB	UNK			NONE	~ ()~~~In patient		1						1	Dyspnoea; Paraesthesia; Tremor	FLU3~PFIZER\WYETH~4968168~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0094821	02/05/1997	MI	90.0	90		F	10/25/1996	pt recv vax 17OCT96 & devel pain @ site, swelling & extensive ecchymosis of rt upper arm;				Y					Y	10/17/1996	10/17/1996	0		OTH	PUB	Antihypertensive meds	HTN	HTN & COPD	NONE~ ()~~~In patient	MI97004	1						1	Ecchymosis; Injection site pain; Oedema	FLU3~PFIZER\WYETH~4968144~7+~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0094825	02/05/1997	MI	44.0	44		F	01/07/1997	large red sore spot, @ the area of the shot;red area 35mm round-warm to touch & hardened area under skin									Y	10/29/1996	10/30/1996	1		PUB	PVT	Redux	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~PFIZER\WYETH~4968168~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0094826	02/05/1997	MI	46.0	46		F	01/07/1997	arm heavy feeling & red swollen 2-3 inch diameter @ inj site for 3 days p/vax given;site hot to touch;knot in inj;location still prevalent 3 days p/vax;									Y	10/21/1996	10/21/1996	0	NONE	PUB	UNK		NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4968168~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0094662	02/06/1997	SC	43.0	43		M	12/31/1996	pt recv vax 20DEC96 1230PM & pt became pale, sweating profusely & was in pain (both chest & jaw) & SOB;EMS transported pt to local hosp ER:BP was 1/2 nl 90/50;died 830PM;	Y	12/20/1996							N	12/20/1996	12/20/1996	0	unk	PUB	PUB		NONE	asthma		SC96071	1						1	Back pain; Chest pain; Dyspnoea; Hyperhidrosis; Hypotension; Myocarditis; Pallor; Pericarditis	FLU3~CONNAUGHT LABORATORIES~6F71316~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0094664	02/06/1997	NJ	40.0	40		U		pt recv vax 18NOV96 & 20NOV pt devel ipsilateral lymphangitis lasting 2 days;this was followed by an allergic rash which has been steroid resistant;								Y	N	11/18/1996	11/20/1996	2	CBC, SMAC, LFT's all nl;	UNK	UNK	NONE		NONE	~ ()~~~In patient		1						1	Hypersensitivity; Lymphangitis; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0094665	02/06/1997	VA	51.0	51		F	12/02/1996	severe hives, flushing (of face & ears);pt recv vax 17OCT96 2PM;pt had tx w/DPH, pred, zantac & po DPH;				Y						10/17/1996	10/18/1996	1		UNK	UNK			NKA;	~ ()~~~In patient		1						1	Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0094842	02/06/1997	MA	60.0	60		F	11/30/1996	pt w/hx of asthma, stable;pt recv flu shot-over next 24hr had asthma exacerbation not relieved w/meds;required ER visit;				Y						11/11/1996	11/11/1996	0		UNK	UNK			hx DM, asthma AUG96;	~ ()~~~In patient		1						1	Asthma; Condition aggravated	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0094843	02/06/1997	NC				F	11/23/1996	urticarial rash;										11/18/1996				UNK	UNK			NONE	~ ()~~~In patient		1						1	Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71222~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0094850	02/06/1997	SC	47.0	47		F	12/02/1996	5NOV96 severe h/a-dull-felt like allergic h/a;6NOV felt icky-stayed home from work;15NOV h/a gone completely;									Y	11/04/1996	11/05/1996	1		UNK	UNK			allergies-takes allergy shots & had 1 prior to flu vax;	~ ()~~~In patient	SC96076	1						1	Headache; Hypersensitivity; Malaise	FLU3~PARKE-DAVIS~00986P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094853	02/06/1997	SC	64.0	64		F	01/09/1997	15-20min itchy eyes;30-45min oral edema;24hr p/vax inj site skin rxn 7.5 x 4cm will check w/allergist re: next flu shot & whether to get it;									Y	11/16/1996	11/16/1996	0		PUB	PUB	Theodur;Premarin, Lotensin	NA	mold, dust, sulfites, yeast	~ ()~~~In patient	SC96075	1						1	Face oedema; Injection site reaction; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0094859	02/06/1997	SC	46.0	46		F	11/01/1996	pt recv vax & noticed redness & swelling w/warmth to touch;area has enlarged @ this reporting;advised to apply moist heat;called MD should sx persist or worsen;									Y	10/30/1996	10/31/1996	1		PUB	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient	SC96065	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PARKE-DAVIS~00986PP~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094860	02/06/1997	SC	5.0	5		M	11/07/1996	pt recv vax 4NOV96 & father noticed hives on pt 5NOV96 when pt got out of bed that morning;father gave DPH & hives were completely gone the morning of 6NOV96;									Y	11/04/1996	11/05/1996	1		PUB	OTH	NONE	NONE	NONE	~ ()~~~In patient	SC96066	1						1	Urticaria	FLU3~PARKE-DAVIS~00986P~1~~LL~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094862	02/06/1997	SC	83.0	83		F	12/30/1996	pt recv vax 23DEC96 & woke up 24DEC96 & for 6 days saw images on walls, worms on hand, gold objects;images were in detail & color;									Y	12/23/1996	12/24/1996	1	NONE	PUB	PUB	Ventolin inhaler, Lodeine, Multivitamin	NONE	asthma, arthritis	~ ()~~~In patient	SC96068	1						1	Hallucination	FLU3~CONNAUGHT LABORATORIES~6F71316~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0094883	02/10/1997	IL	62.0	62		M	02/03/1997	large ecchymosis @ inj site;									Y	10/14/1996	10/19/1996	5	protime 15.2 20SEP96 INR 1.4;Protime 15.2 4NOV96 INR 1.5;	PVT	UNK	Minitran;Lisinopril;Dilantin;Coumadin, Procardia	NONE	HTN, coronary artery disease, sz disorder;	NONE~ ()~~~In patient		1						1	Ecchymosis; Injection site inflammation	FLU3~CONNAUGHT LABORATORIES~6F71194~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0094890	02/10/1997	SC	65.0	65		F	01/14/1997	2 days p/vax pt started w/pain & redness @ inject site;migrated to entire arm, across chest, neck, shoulders, & underneath breast;felt like someone walking on chest;SOB also;felt like having heart attack;to MD 1hr later w/soreness;				Y					Y	12/30/1996	01/01/1997	2		PUB	UNK		NONE	med for inc BP Ziac	~ ()~~~In patient	SC96074	1						1	Chest pain; Dyspnoea; Injection site hypersensitivity; Injection site pain; Myalgia; Pain; Vasodilatation	FLU3~PARKE-DAVIS~00596P~4~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0093537	02/11/1997	VA	71.0	71		F	02/07/1997	dx acute transverse myelitis;total hemiparesis from waist down preceded by numbness, tingling;also some trembling & weakness of upper limbs w/neuropathy of chest;pain chest;pt felt exp was frightening;					Y	3		Y	N	10/25/1996	10/26/1996	1	MRI,X-rays, blood tests, many labs;	PUB	OTH	NONE	cataracts both eyes	cancer surgery, completely recovered MAR96	~ ()~~~In patient		1						2	Laboratory test abnormal; Myasthenic syndrome; Myelitis; Paraesthesia; Asthenia; Chest pain; Hemiplegia; Myelitis; Neuropathy; Pain; Paraesthesia; Tremor	FLU3~PFIZER\WYETH~4968170~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968170~1~A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation,Disabling	Influenza
0094834	02/11/1997	TN	42.0	42		M	12/23/1996	pt recv vax 31OCT96 & 12NOV96 lt hand became numb & unable to move;adm to hosp on 18NOV d/ 23NOV96;MD dx GBS;c/o bumps on soles of feet;					Y	4				10/31/1996	11/12/1996	12	MRI, EMG, muscle tests w/probes in arm;	PVT	PVT		several recent surgeries for disc in neck		~ ()~~~In patient	TN97008	1						1	Guillain-Barre syndrome; Hypokinesia; Paraesthesia; Skin nodule; Asthenia; Guillain-Barre syndrome; Paralysis	FLU3~CONNAUGHT LABORATORIES~6F71227~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0094939	02/11/1997	TX	39.0	39		M	02/06/1997	Thrombocytopenia 205-17-209 w/o rx;				Y					Y	11/26/1996	12/04/1996	8	SMA, HGB, WBC all OK	OTH	OTH	VIt C		allergic keflex	~ ()~~~In patient		1						1	Thrombocytopenia	FLU3~CONNAUGHT LABORATORIES~6F71307~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0095034	02/11/1997	MN	59.0			F	11/13/1996	pt recv vax & subsequently devel flu-like sx;									Y					OTH	OTH	unk	unk		pt recv vx 95/96 w/o adverse exp;pt exp stiff & sore lt arm & rt leg 96/97 dose~ ()~~~In patient	897009016L	1						1	Influenza; Gait disturbance; Hypertonia; Hypokinesia; Myalgia	FLU3~PFIZER\WYETH~~1~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968163~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0095181	02/11/1997	GA	64.0	64		F	12/19/1996	c/o numbness & tingling in arm & hand;arm & hand go to sleep-pain in arm if pt lies on that side;saw PMD 17DEC96 given med;									N	10/09/1996	10/09/1996	0		PUB	PUB	muscle relaxant	NONE	NONE	NONE~ ()~~~In patient	GA96166	1						1	Pain; Paraesthesia	FLU3~PARKE-DAVIS~00886P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0091647	02/12/1997	OH	26.0	26		F		w/in 60-90min p/vax c/o flushing & chills, felt like had temp (temp was 98);site of inj was reddened & swollen;										10/15/1996	10/15/1996	0	NA	UNK	UNK	NA		NA	~ ()~~~In patient		1						2	Chills; Injection site hypersensitivity; Injection site oedema; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4968181~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0091659	02/12/1997	OH	48.0	47		F	10/18/1996	p/vax c/o dizziness, diaphoretic, pale, eyes bloodshot 24hr p/vax;site reddened & swollen p/24hr;became SOB 12hr p/vax;										10/15/1996	10/15/1996	0	NA	UNK	UNK	NA		NA	~ ()~~~In patient		1						2	Conjunctivitis; Dizziness; Hyperhidrosis; Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4968181~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0091660	02/12/1997	OH	61.0			F	10/21/1996	24hr p/vax arm was reddened & swollen (55 x 40mm);											10/15/1996		NA	UNK	UNK			NA	~ ()~~~In patient		1						2	Oedema peripheral; Vasodilatation	FLU3~PFIZER\WYETH~4968181~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0094047	02/12/1997	NY	56.0	56		M	02/03/1997	no hx of viral illness, but recv flu vax approx 2wk prior to admission;pt c/o sudden onset paralysis, generalized;neuro work-up revealed demyelinating disease consistent w/GBS;					Y	20			Y	12/30/1996	01/13/1997	14		PVT	PVT	NONE	NONE	NONE	NA~ ()~~~In patient		1						3	Asthenia; CSF test abnormal; Depression; Guillain-Barre syndrome; Myasthenic syndrome; Neuropathy; Paralysis; CSF test abnormal; Guillain-Barre syndrome; Neuropathy; Guillain-Barre syndrome; Neuropathy; Paralysis	FLU3~CONNAUGHT LABORATORIES~6F71277~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71277~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Hospitalisation	Influenza
0094924	02/12/1997	MN				F	02/06/1997	pt recv vax 29OCT96 & was later hospitalized for GBS;medical director spoke w/PMD who did not report direct correlation between synd & flu vax;					Y				Y	10/29/1996	11/20/1996	22	NA	PUB	PVT	NONE	information NA		~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~6F71273~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0094982	02/12/1997	NC	62.0	62		F	11/28/1995	18NOV95 devel h/a, dizziness & fever of 99;19NOV95 devel muscle weakness; no c/o numbness or tingling in extremities;22NOV95 seen by MD w/c /o dizziness w/nausea x 3-4days upper resp congestion afeb;rx for ATB;									Y	11/17/1995	11/18/1995	1	NA	PUB	PUB	NONE	NONE	migraine h/a;inner ear problems	~ ()~~~In patient	NC96144	1						1	Dizziness; Headache; Myasthenic syndrome; Nausea; Pharyngitis; Pyrexia	FLU3~PFIZER\WYETH~4958128~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0094983	02/12/1997	CA	83.0			F	11/20/1996	pt recv flu vax instead of tetanus;reporter states label are similar, sl variation of color or label stripe, same size vial, white label, black writing, stripes on vial pink & darker pink/orange;no adverse rxn @ time of vax;											11/20/1996			UNK	UNK			pt had hx of rxn flu vax in 1989	~ ()~~~In patient		1						1	Unevaluable event	FLU3~CONNAUGHT LABORATORIES~6F71320~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0094988	02/12/1997	IN	9.0	9		M	10/18/1996	pt recv vax 7OCT96 & on 10OCT96 c/o abd pain w/vomiting;t100.3 sent to hosp for 23hr eval;c/o abd w/nausea several days;mom thought could be rxn to flu vax;										10/07/1996	10/07/1996	0	pt took flu vax last yr w/no problems;	UNK	UNK				~ ()~~~In patient		1						1	Abdominal pain; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~6F71248~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0094989	02/12/1997	MD	68.0			F	10/23/1996	site of flu vax red, swollen, & itching;											10/22/1996		NA	UNK	UNK			known allergies PCN, iodine, Mandol, Flagyl	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~CONNAUGHT LABORATORIES~6F71288~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0095004	02/12/1997	CO	72.0	72		M	12/27/1996	24DEC96 fever, severe body aches, tight chest, head cold, chills;										11/12/1996	12/24/1996	42	did not see MD	PUB	PUB	NONE	NONE	hay fever in spring	~ ()~~~In patient	CO96066	1						1	Chest pain; Chills; Myalgia; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~0576P~7+~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0094922	02/13/1997	WA	22.0	21		M	02/07/1997	pt recv vax & 1 wk later exp soreness, redness throat, fever, aches all over body;			Y						Y	10/19/1995				UNK	UNK				~ ()~~~In patient		1						1	Myalgia; Pharyngitis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~4948116~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0094931	02/18/1997	MA	75.0			F	02/06/1997	pt recv vax in DEC96 & pt appeared to be developing GBS & was transferred to another facility for tx;							Y		U		01/09/1997			OTH	OTH			fractured humerus	~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0095128	02/18/1997	WI	36.0	36		M	02/06/1997	pt devel visual problems & h/a;dx as optic neuritis lt eye;responded completely to pulse solumedrol;w/in 1wk of stopping neuritis recurred;				Y					U	12/09/1996	12/18/1996	9		PVT	PVT	NONE	NONE	hx allergies (multiple environmental) desenitization rx >10yr ago;distant hx prostatitis;	~ ()~~~In patient		1						1	Headache; Neuritis; Optic neuritis; Visual disturbance	FLU3~PFIZER\WYETH~4968178~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095135	02/18/1997	OK	67.0	67		F	12/23/1996	arm swelled-gen malaise saw MD & got med;				Y						12/19/1996	12/19/1996	0	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	OK978	1						1	Malaise; Oedema peripheral	FLU3~PARKE-DAVIS~1286P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1626B~UNK~A~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0095149	02/18/1997	OK	47.0	47		F	02/10/1997	pt c/o itching, neck red, raised rash noted;denies SOB or pain;									Y	01/06/1997	01/06/1997	0		PUB	PVT	Maalox, pepcid	r/o cholecystitis	NONE	~ ()~~~In patient		1						1	Pruritus; Rash maculo-papular; Vasodilatation	FLU3~PFIZER\WYETH~4968163~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~1|TD~PFIZER\WYETH~4968109~UNK~IM~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0094958	02/19/1997	MN	63.0	63		M	02/08/1997	GBS				Y	Y	12			Y	10/01/1996	11/29/1996	59		OTH	PVT		NONE	NONE	~ ()~~~In patient	MN97004	1						1	Asthenia; Guillain-Barre syndrome; Muscle twitching; Neuropathy; Pain; Paralysis	FLU3~MEDEVA PHARMA, LTD.~E3026GA~7+~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0095202	02/19/1997	ID	55.0	55		F	01/10/1997	pt reports 2 days p/vax devel swelling in rt leg;eval for DVT negative;saw MD several times & referred to circulatory specialist;CT scan indicated abd mass w/lymph node involvement;biopsy done dx lymphoma;pt felt vax triggered immune				Y					U	10/24/1996	10/26/1996	2	CT scan	PVT	PVT	Estrogen-mult vit & calcium	NONE	NONE	NONE~ ()~~~In patient	ID97002	1						1	Abdominal distension; Cardiovascular disorder; Immune system disorder; Lymphadenopathy; Oedema peripheral; Pseudo lymphoma	FLU3~PFIZER\WYETH~4968146~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095203	02/19/1997	ID	38.0	38		F	12/30/1996	5NOV96 630PM pt devel a sore throat, puffy eyes, racing heart beat, throat began to swell shut & itching;pt went to ER where recv adrenalin & began to feel better pt was sent home w/med;				Y					Y	11/04/1996	11/05/1996	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	ID97003	1						1	Face oedema; Laryngospasm; Pharyngitis; Tachycardia	FLU3~PFIZER\WYETH~4968162~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0094967	02/20/1997	NH	61.0	61		F	02/12/1997	pt recv vax  26NOV96 & 19DEC to ER weakness legs/dysarthria, facial droop;transferred to another hosp-d/c to rehab;readmitted 6JAn-7JAN d/c to rehab;readmitted 7FEB;d/c to rehab;dx GBS;				Y	Y		Y		N	11/26/1996	12/17/1996	21	LP negative;bone series negative;	PVT	PVT	Pred, Premarin, Elavil, Axid, Synthroid, Lopid, Lopressor, ASA	NONE	PCN allergy, hypothyroid, HTN hypedipidemia post hyst	unk~ ()~~~In patient	NH97005	1						1	Dysarthria; Facial palsy; Guillain-Barre syndrome; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~6F71273~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0095156	02/20/1997	NJ	26.0	26		F	02/07/1997	pt stated that 3hr p/vax devel t103, body aches, chills, vomiting, sore throat;pt was seen in office 16hr p/vax initiated temp was 101.2, vomiting stopped;still c/o nausea, runny nose, body aches;				Y					Y	02/05/1997	02/05/1997	0		PVT	PVT	Humulin insulin		IDDM	~ ()~~~In patient		1						1	Chills; Myalgia; Nausea; Pharyngitis; Pyrexia; Rhinitis; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71313~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0095161	02/24/1997	KY				M	01/22/1997	pt recv vax 10OCT96 & was hosp & dx of GBS on 30DEC96;No further information was available @ the date of this report;this is a serious, labelled event;It is being submitted in a 15-day time frame was requested by FDA;					Y				U	10/10/1996				PVT	PVT	UNK	NONE		~ ()~~~In patient	897023013L	1						1	Guillain-Barre syndrome	FLU3~PFIZER\WYETH~4968166~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0095249	02/24/1997	PA	47.0			F	12/18/1996	pt c/o erythema & urticaria @ inj site										10/08/1996	10/09/1996	1		UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~00296P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0095261	02/24/1997	SC	69.0	69		F	01/10/1997	pt recv vax lt arm;excruciating pain started immed & has cont off & on limited mobility of lt arm;has not seen PMD for dx/tx;									U	12/27/1996	12/27/1996	0	NA	PUB	UNK	NONE	NONE	NONE	~ ()~~~In patient	SC97006	1						1	Hypokinesia; Pain	FLU3~CONNAUGHT LABORATORIES~6F71316~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0095329	02/24/1997	FL				U	10/09/1996	pt devel serious flu requiring hosp p/vax;No further info was available @ the date of this report;					Y				Y					OTH	OTH	unk	unk		~ ()~~~In patient	896302035L	1						1	Influenza	FLU3~PFIZER\WYETH~4958118~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0095338	02/24/1997	FL				U	10/09/1996	pt devel possibly attenuated flu p/vax;									Y					OTH	OTH	unk	unk		~ ()~~~In patient	896283005L	1						1	Influenza	FLU3~PFIZER\WYETH~4958118~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095339	02/24/1997	PA	39.0	39		F	10/02/1996	w/in hr of vax pt devel a fever & malaise which persisted for 1wk;									Y	11/08/1995	11/08/1995	0		PVT	PVT	Betaseron	NONE	multiple sclerosis	pt reported no adverse exp following receipt of flu vax 94/95 formula~ ()~~~In patient	896285025L	1						1	Malaise; Pyrexia	FLU3~PFIZER\WYETH~4958109~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095340	02/24/1997	IA	43.0	43		F	10/08/1996	pt recv vax OCT95 & devel inj site rxn characterized by a 5 to 6 cm area of redness, warmth, itching & a lump;these sx persisted for 1wk; also exp pain @ inj site described as deep muscle pain;									Y	10/01/1995	10/01/1995	0		OTH	OTH	NONE	NONE		pt has recv flu vax since 1990 & has always exp some effect from the inj~ ()~~~In patient	896295006L	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Myalgia; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095341	02/24/1997	IL	51.0	51		M	10/18/1996	pt recv vax & devel fever & chills 48hr p/vax these resolved;3mo post vax pt devel weakness in the jaw & face w/diff talking & swallowing;dx w/myasthenia gravis & tx w/med;dx changed to ALS then to dystonia;diff w/speech & swallowing;				Y					N	11/01/1995	02/01/1996	92		OTH	PVT	NONE	unk		~ ()~~~In patient	896295030L	1						1	Chills; Dysphagia; Dystonia; Myasthenic syndrome; Neuropathy; Pyrexia; Speech disorder	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095342	02/24/1997	FL				U	10/09/1996	pt devel serious flu following vax;									Y					OTH	OTH	unk	unk		~ ()~~~In patient	896302034L	1						1	Influenza	FLU3~PFIZER\WYETH~4958118~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095343	02/24/1997	FL				U	10/09/1996	pt recv vax & devel possibly attenuated flu;									Y					OTH	OTH	unk	unk		~ ()~~~In patient	896302036L	1						1	Influenza	FLU3~PFIZER\WYETH~4958118~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095344	02/24/1997	MD	44.0	43		M	11/04/1996	pt recv vax & pt devel a rash w/papules on the bad & bilat antecubital & popliteal areas;pt recovered;									Y	10/01/1995	10/01/1995	0		PVT	OTH	NONE	NONE		~ ()~~~In patient	896316007L	1						1	Rash maculo-papular	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095345	02/24/1997		41.0			F	11/07/1996	pt recv vax & devel a mild gen rash;									Y					OTH	OTH	unk	unk	allergic to Cleocin, Tetracycline, lidocaine, Erythromycin	~ ()~~~In patient	896318015L	1						1	Rash	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095346	02/24/1997	OR	34.0	34		F	11/11/1996	2NOV95 pt recv vax & exp discomfort;2 noc p/vax pt fell asleep w/inj arm over head & awoke next morning w/arm pain & dec mobility of the arm & shoulder;dx w/frozen shoulder tx w/physical therapy;				Y					N	11/02/1995	11/02/1995	0		OTH	OTH	NONE	unk	diet controlled diabetes mellitus type II	~ ()~~~In patient	896318026L	1						1	Arthropathy; Hypokinesia; Pain	FLU3~PFIZER\WYETH~~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095347	02/24/1997	TN	41.0			F	11/07/1996	pt recv vax & devel inj site rxn;									Y					OTH	OTH	unk	unk		pt devel an inj site rxn, aching, malaise & diarrhea p/flu vax;~ ()~~~In patient	896324005L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095348	02/24/1997	SC	66.0	66		F	11/08/1996	pt recv vax & devel a fever & an inj site rxn characterized by erythema, edema, & pain;pt tx w/ATB & recovered p/1wk;									Y	10/01/1995				PVT	OTH	unspecified inhaler	NONE		~ ()~~~In patient	896338001L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095234	02/25/1997	AZ	59.0	59		F	02/20/1997	by evening pain @ site & axilla x 2 days;has had occurrence w/activity & exercise since;no med eval yet sought;referred to PMD;				Y					U	11/09/1996	11/09/1996	0		PUB	PUB		NONE	breast CA rt, allergic PCN	~ ()~~~In patient		1						1	Injection site pain; Pain	FLU3~PFIZER\WYETH~4968162~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0221D~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0095236	02/25/1997	MN	3.0	3		M	02/17/1997	devel varicella 7DEC96 @ home reaffirmed by mom 17FEB97;									Y	10/13/1995	02/17/1997	493		PVT	PVT		NONE	27 wk premie;PDA, KDJ, RHD	~ ()~~~In patient		1						1	Drug ineffective; Infection	FLU3~CONNAUGHT LABORATORIES~5F71006~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0437B~UNK~IM~~VARICELLA (VARIVAX)~1	USA		Influenza
0095385	03/03/1997	CA	47.0	47		F	02/25/1997	48hr p/vax pt exp severe joint pain in rt ankle, rt shoulder, rt wrist for 3 days, resolved p/3rd day;									Y	10/15/1996	10/17/1996	2	NONE	OTH	OTH	Ibuprofen p/vax	NONE	NONE	NONE~ ()~~~In patient		1						1	Arthralgia	FLU3~PFIZER\WYETH~4968177~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095412	03/04/1997	TN	76.0	75		M	02/21/1997	pt recv vax 18NOV96 & approx 2 days later pt devel flu-like sx including excruciating pain in both arms, shoulders & hands;hip pain off & on;edema bilat;dx DJD;vascular necrosis;aches worse since vax;inc stiffness;arthritis;arthralgia				Y					N	11/18/1996	11/20/1996	2	27DEC FSR 27 7.2/13.4/40.6/238;rt hip nl;UA negative;Ca 9.4;PO4 3.3;UA 5.4;glucose 95;bili 0.4;ap 58;CBC nl;rheumat <20.0;142/109/15/4.7/28/1.0	PVT	PVT	NONE	NONE	NONE x/allergies	NONE~ ()~~~In patient		1						1	Arthralgia; Arthritis; Arthropathy; Bone disorder; Condition aggravated; Influenza; Oedema peripheral; Osteonecrosis	FLU3~CONNAUGHT LABORATORIES~6F71247~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|TTOX~LEDERLE LABORATORIES~431952~UNK~~~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0095414	03/04/1997	VA	66.0	66		F	10/08/1996	broke out in hives on rt arm, chest;went to intermediate care ctr;given DPH & cortisone inj IM;given rx for tapering pred & DPH;mild SOB;				Y					Y	10/08/1996	10/08/1996	0	NONE	OTH	OTH	Tamoxifen;ASA	NONE	NONE	~ ()~~~In patient	VA96067	1						1	Dyspnoea; Urticaria	FLU3~PFIZER\WYETH~4968173~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095417	03/04/1997	VA	59.0	59		F	11/08/1996	a rash first noticed on 8NOV96 morning;warm to palpation;borderline sl raised;size 2.5 x 1.5; t98;no resp problems;no GI complaints;physically healthy & nl;										11/06/1996	11/08/1996	2	NA	PUB	PUB		NONE	NONE	NA~ ()~~~In patient	VA96078	1						1	Rash; Vasodilatation	FLU3~PFIZER\WYETH~4968173~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095424	03/04/1997	VA	37.0	37		F	10/29/1996	18hr pain/redness/swelling @ site (2-4diameter);24hr severe muscle aches, t104.8;dx cellulitis started Ceflex sx more severe (4-6_;48hr cellulitis @ site 8+ diameter;sx cont;72hr t101.2 started pred;muscle aches severe, site-blacki				Y					Y	10/25/1996	10/26/1996	1	26OCT96 WBC 19,000+	PUB	PUB	MS Contin;Pyridium;Ultram;Flexorel;Restoril;Birth Control pills	NONE	1989 spinal cord injury (L4,5-F1);CSF leaks hx bladder/perpherial neuropathy 1989-1995	none~ ()~~~In patient	VA96071	1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia; Skin discolouration	FLU3~PFIZER\WYETH~4968136~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~435955~1~SC~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0095426	03/04/1997	VA	41.0	41		M	12/12/1996	swelling, redness, pain rt arm approx 1 from inj site-first noticed this AM-extends to axilla;pt nl takes Hismanual, Zestril;pt returned to clinic 12DEC96 to report sx & was seeing CNP;				Y					U	12/10/1996	12/12/1996	2		PUB	PVT	Hismanal, Zestril	NONE	PCN	~ ()~~~In patient	VA96088	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4968136~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~435955~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0095432	03/04/1997	VA	54.0	53		F	11/13/1996	during fir few days reports sore arm w/@ knot 3 in diameter, tired, weak, sore throat & mild h/a;by 6th day p/getting flu vax had fever (no over 100);chills, joint aches from neck to groin (not legs);exhausted & flat on back, vertigo;saw M				Y					Y	10/05/1996	10/11/1996	6	NONE	PUB	PUB	NONE	NONE	PCN, sulfa, tetracycline, Iodine used for kidney x-ray	~ ()~~~In patient	VA96082	1						1	Arthralgia; Asthenia; Hypokinesia; Myalgia; Pharyngitis; Pyrexia; Skin nodule; Vertigo	FLU3~PFIZER\WYETH~4968136~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095435	03/05/1997	NY	87.0			F	02/20/1997	angioneurotic edema, swelling of tongue secondary Prinivil & flu vax;upper airway compromise/obstruction-intubation;Solumedrol & DPH;versed Morphine given;pt improved-extubated;			Y		Y						10/24/1996		IGg 1670 inc;	UNK	UNK	Prinivil, Zantace			~ ()~~~In patient		1						1	Angioneurotic oedema; Hypoxia; Immunoglobulins increased; Respiratory disorder; Tongue oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0095451	03/05/1997	MI	47.0			F		while taking shower 6DEC approx 24hr p/vax lt arm devel pain/burning in lt axillary region;palpable tenderness w/o specific lt axillary lymphadenopathy;										12/05/1996	12/06/1996	1	NONE	UNK	UNK			allergies h/o silicone implants (b) 82' had to s/p TAH have both replaced 92 w/saline implant	~ ()~~~In patient		1						1	Lymphadenopathy; Pain	FLU3~CONNAUGHT LABORATORIES~6F71273~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0095455	03/05/1997	CO				F	02/20/1997	the morning post vax pt arm where recv inj started to itch & become sore & hot area was from the elbow to the shoulder;evening the arm started to swell;next morning pt arm swelled big enough that it was noticeable;black & blue;									Y	10/22/1996	10/22/1996	0		UNK	UNK			nka	~ ()~~~In patient		1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Pruritus; Skin disorder; Vasodilatation	FLU3~PARKE-DAVIS~01386P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0095462	03/05/1997	MN	61.0	61		F	02/25/1997	initial sx-laryngitis followed by cough for 2wk then low back pain/stiffness, significant pain in low back traveling from side to side;unable to get up on own d/t pain & sore muscles (typically very active);cont w/muscle pain				Y					N	10/15/1996	10/26/1996	11	CXR-lab work;	OTH	OTH	Blood pressure meds	NONE	NKA	NONE~ ()~~~In patient		1						1	Back pain; Cough; Hypertonia; Hypokinesia; Laryngitis; Myalgia	FLU3~PFIZER\WYETH~~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095467	03/05/1997	CA	33.0	32		F	02/26/1997	23OCT96 1st ER visit w/ c/o lt arm pain, lt arm tingling, pain on flexion pulling/lifting dec grip strength;f/u visits x 3 w/hand specialist (NOV,DEC,JAN) requiring rest & advil;				Y					N	10/10/1996	10/12/1996	2	NONE	OTH	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Hypokinesia; Myasthenic syndrome; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4968177~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095475	03/05/1997	IL	22.0			F	10/22/1996	urticaria tx w/DPH				Y					Y	10/22/1996	10/22/1996	0		MIL	MIL	NONE	NONE		~ ()~~~In patient		1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0091661	03/06/1997	OH	46.0	46		F	10/22/1996	pt recv vax in AM & that evening pt devel itching, redness, & swelling measuring 70mm x 45mm @ the inj site;this is 1 of 12 pt from this site to have an adverse rxn;									U	10/16/1996	10/16/1996	0		PVT	PVT	NONE	NONE		~ ()~~~In patient	896303042L	1						2	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4968181~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0091663	03/06/1997	OH	80.0	80		M	10/22/1996	pt recv vax in AM;that evening exp SOB just didn't feel well & redness & swelling @ inj site;this is 1 of 12 pt from this site to have an adverse rxn;									U	10/14/1996	10/14/1996	0		PVT	PVT	NONE	NONE		~ ()~~~In patient	896303036L	1						2	Dyspnoea; Injection site hypersensitivity; Injection site oedema; Malaise	FLU3~PFIZER\WYETH~4968181~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0092250	03/06/1997	MT	29.0	29		F	12/11/1996	pt recv vax & exp itching @ the site of flu vax;the next evening site of flu vax became red & swollen;pt devel pain in the shoulder & hips, h/a, numbness of the rt arm, burning of the rt side of the body, confusion, & forgetfulness;				Y					U	10/30/1996	10/30/1996	0		PUB	OTH	NONE	NONE	surgical repair of stomach problems	~ ()~~~In patient	896353002L	1						2	Amnesia; Arthralgia; Confusional state; Headache; Injection site hypersensitivity; Injection site oedema; Paraesthesia; Pruritus	FLU3~PFIZER\WYETH~4968164~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~433403~1~IM~LA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0092646	03/06/1997	MA	42.0	42		F	11/25/1996	pt recv vax & devel a neurological problem & weakness;no further info was available @ the date of this report;addtl info was  recv 31DEC96;pt exp paresthesias in the hands, legs, feet, neck & back;pt was seen by neurologist & tx w/prozac;				Y					U	10/28/1996	10/31/1996	3	ESR, B12, folate, CBC, chem A, chem B all reportedly nl;	PUB	PVT	Synthroid	NONE	goiter	~ ()~~~In patient	896337024L	1						2	Asthenia; Neuropathy; Paraesthesia	FLU3~PFIZER\WYETH~4968200~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0093416	03/06/1997	ID	26.0	26		F	12/02/1996	approx 48hr p/vax pt devel facial hives;tx w/DPH & the hives initially subsided;pt has subsequently exp several episodes of facial hives by throat constriction & swelling of tongue;tx in ER w/epi;				Y					U	10/29/1996	11/01/1996	3		PVT	OTH	NONE	nONE	recurring hives @ age 13;etiology not determined;	~ ()~~~In patient	896339009L	1						2	Laryngospasm; Tongue oedema; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0094826	03/06/1997	MI	46.0	46		F	10/25/1996	pt recv vax & devel an inj site rxn characterized by redness & a lump measuring 3.5inches in diameter;tx w/hydrocortisone then w/a steroid cream;this is one of 2 patients from this site to devel an inj site rxn p/vax;									U	10/21/1996	10/21/1996	0		OTH	OTH	unk	unk		~ ()~~~In patient	896311012L	1						2	Asthenia; Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4968168~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0095034	03/06/1997	MN	61.0	61		F	12/15/1996	w/in a few hr of vax pt lt arm became stiff & sore;pt was unable to use arm for 2 days;pt self-treated w/ice packs, Ibuprofen, & APAP;soreness resolved p/4 days;pt rt leg became sore & caused pt to limp for 2 days;									Y	11/04/1996	11/04/1996	0	NONE	PUB	PUB	Calan	NONE	heart flutter	pt exp flu-like sx in 94-95 w/flu vax;~ ()~~~In patient	896362001L	1						2	Influenza; Gait disturbance; Hypertonia; Hypokinesia; Myalgia	FLU3~PFIZER\WYETH~~1~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968163~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0095442	03/06/1997	LA	58.0	58		F	02/28/1997	numbness in hands, pain in hands, numbness in toes & feet;referred to neuro & dx w/acute polyradiculoneuropathy;hosp 19NOV96 to 26NOV96 & tx w/steroids;					Y	7			Y	10/14/1996	11/01/1996	18	spinal tap	PVT	UNK	Synthroid, Monopril, Pravachol, Premarin	NONE	hypothyroid;HTN	~ ()~~~In patient		1						1	Neoplasm; Neuropathy; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4968151~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0095641	03/06/1997	MN	57.0	57		F	12/15/1996	several hr p/vax pt devel a pruritic rash in both axillae, groin area, & under stomach & breast folds;rash was described as a mass of red w/a few white pimples;pt self-treated w/hydroxyzine & seldane;									U	10/29/1996	10/29/1996	0	NONE	PUB	PUB	furosemide;Klor-CON	NONE	HTN;chicken & dust allergies;rash w/sulfa drugs, lotensin, & maxzide	pt had no adverse exp following receipt of the 95-96 flu vax~ ()~~~In patient	896362002L	1						1	Acne; Pruritus; Rash	FLU3~PFIZER\WYETH~4968163~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095642	03/06/1997	FL	31.0	31		F	12/03/1996	30min following receipt of flu vax pt exp dizziness w/nausea;blood glucose was 79;									U	10/23/1996	10/23/1996	0		OTH	OTH	unk	unk	hx of hypoglycemia	~ ()~~~In patient	896362003L	1						1	Dizziness; Nausea	FLU3~PFIZER\WYETH~4968166~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095643	03/06/1997	FL	42.0	42		F	12/03/1996	10min p/vax pt exp nausea, dizziness, & diaphoresis;BP was noted to be 80/60 (usual BP 90/70) & pulse was 52 beats/min;sx abated @ which time BP was 118/70 & apical pulse was 82 beats /min;									Y	11/04/1996	11/04/1996	0		OTH	OTH	unk	unk		~ ()~~~In patient	896362004L	1						1	Dizziness; Hyperhidrosis; Hypotension; Nausea	FLU3~PFIZER\WYETH~4968206~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095644	03/06/1997	FL	20.0	20		F	12/03/1996	immed p/vax pt felt hot & began to perspire;pt then exp dizziness, blurred vision, & nausea;pt was placed in a supine position & was given an ammonia ampule & oral fluids;pt recovered w/in 30min;									Y	11/01/1996	11/01/1996	0		OTH	OTH	Advil-aleve;Vitamins	unk		~ ()~~~In patient	896362005L	1						1	Amblyopia; Dizziness; Hyperhidrosis; Nausea; Vasodilatation	FLU3~PFIZER\WYETH~4968138~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095645	03/06/1997	FL	26.0	26		M	12/03/1996	15min p/vax pt exp a syncopal episode;@ that time pulse was 40 beats/min, thready, & irregular;pt was ashen, diaphoretic, & only sl responsive;20min later pulse was 80 beats/min & BP was 120/80;									Y	10/22/1996	10/22/1996	0		OTH	OTH	NONE	NONE	pt recalls one syncopal episode years ago	~ ()~~~In patient	896362007L	1						1	Arrhythmia; Bradycardia; Hyperhidrosis; Pallor; Stupor; Syncope	FLU3~PFIZER\WYETH~4968166~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095646	03/06/1997	WI	61.0	61		M	12/31/1996	w/in 30min of vax pt exp aching of entire lt arm;this aching resolved p/approx 12hr;7 days post vax the aching recurred & was unresponsive to ASA;the aching subsided following 2 doses of advil;									Y	11/02/1996	11/02/1996	0	NONE	OTH	OTH	Lanoxin;Cardizem;	NONE	atrial fibrillation	~ ()~~~In patient	897006020L	1						1	Myalgia	FLU3~PFIZER\WYETH~4968206~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095647	03/06/1997	VA	49.0			F	12/27/1996	pt recv vax OCT or NOV96 & 24DEC96 pt exp tiredness;25DEC96 pt devel watery eyes & a runny nose;26DEC96 pt exp chest pain & SOB & went to the ER;@ ER an unspecified arrhythmia was noted which leveled out;pt told had flu				Y					U		12/24/1996			PUB	PVT	Premarin;Synthroid	NONE	thyroid disorder	~ ()~~~In patient	897006023L	1						1	Arrhythmia; Asthenia; Chest pain; Dyspnoea; Influenza; Lacrimal disorder; Rhinitis	FLU3~PFIZER\WYETH~4968173~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095648	03/06/1997	CA	76.0	76		F	12/13/1996	pt recv vax & devel abd tenderness, cramps, & diarrhea;pt recovered p/several days;the responsible MD does not believe this event was r/t vax;									Y	12/04/1996	12/06/1996	2		OTH	OTH	none	none	none	~ ()~~~In patient	897006032L	1						1	Abdominal pain; Diarrhoea	FLU3~PFIZER\WYETH~4968209~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095649	03/06/1997	CA	77.0	77		F	12/31/1996	pt recv vax & soon p/exp a cardiac arrhythmia;the episode lasted about 24hr & resolved w/o intervention;									Y	12/26/1996	12/26/1996	0		PVT	OTH	NONE	NONE	Egg allergy, other unspecified allergies;	~ ()~~~In patient	897007003L	1						1	Arrhythmia	FLU3~PFIZER\WYETH~~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095650	03/06/1997	OH	28.0	28		F	12/30/1996	w/in 10min of vax pt devel redness, swelling & itching @ the site of inj;also exp facial flushing;pt was treated w/oral DPH & the application of ice to the inj site & recovered;this is one of 12 pt from this site to have adverse exp									Y	10/22/1996	10/22/1996	0		PVT	PVT	NONE	NONE		~ ()~~~In patient	897008005L	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4968181~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095651	03/06/1997	OH	54.0	54		F	12/30/1996	pt recv vax & exp pain @ site of inj;6 days post vax a small bruise was noted @ inj site;pt recovered;this is 1 of 12 pt from this site to have an adverse rxn;									Y	10/16/1996	10/28/1996	12		PVT	PVT	NONE	NONE		~ ()~~~In patient	897008008L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4968181~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095652	03/06/1997	OH	54.0	54		F	12/30/1996	3 days p/vax pt felt like had flu w/an upset stomach;pt also devel a 26mm x 63mm area of induration @ the inj site;pt recovered;this is 1 of 12 patients from this site to have an adverse rxn;									Y	10/15/1996	10/18/1996	3		PVT	PVT	NONE	NONE		~ ()~~~In patient	897008009L	1						1	Dyspepsia; Influenza; Injection site mass	FLU3~PFIZER\WYETH~4968181~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095653	03/06/1997	OH	53.0	53		F	12/30/1996	1 day p/vax pt devel a raised 2.5mm x 2.75mm area of redness @ the inj site;no further info was available @ the date of this report;this is 1 of 12 pt from this site to have an adverse rxn;									Y	10/21/1996	10/22/1996	1		PVT	PVT	NONE	NONE		~ ()~~~In patient	897008010L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4968181~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095654	03/06/1997	OH	36.0	36		F	12/30/1996	4 days p/vax pt reported that devel redness & irritation @ the inj site as well as numbness & little function of the third finger of lt hand;									Y	10/17/1996	10/21/1996	4		PVT	PVT	NONE	NONE		~ ()~~~In patient	897008012L	1						1	Hypokinesia; Injection site hypersensitivity; Paraesthesia	FLU3~PFIZER\WYETH~4968181~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095656	03/06/1997	OH	26.0	26		F	10/22/1996	pt recv vax in the AM;1 to 1.5hr later pt devel redness & swelling @ the inj site, chills, & became flushed;this is 1 of 12 pt from this site to have an adverse rxn;									U	10/15/1996	10/15/1996	0		PVT	PVT	NONE	NONE		~ ()~~~In patient	896303038L	1						1	Chills; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4968181~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095657	03/06/1997	OH	48.0	48		F	10/22/1996	pt recv vax & became dizzy, diaphoretic & pale;pt devel blood shot eyes, & redness & swelling @ the inj site;12 hr p/vax became SOB;this is 1 of 12 pt from this site to have adverse rxn;									U	10/15/1996	10/15/1996	0		PVT	PVT	NONE	NONE		~ ()~~~In patient	896303039L	1						1	Conjunctivitis; Dizziness; Dyspnoea; Hyperhidrosis; Injection site hypersensitivity; Injection site oedema; Pallor	FLU3~PFIZER\WYETH~4968181~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095658	03/06/1997	OH	61.0	60		F	10/22/1996	pt recv vax & devel redness & swelling @ the inj site measuring 55mm x 40mm;this is 1 of 12 pt from this site to have an adverse rxn;									U	10/15/1996	10/16/1996	1		PVT	PVT	NONE	NONE		~ ()~~~In patient	896303041L	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4968181~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095660	03/06/1997	OH	56.0	56		F	10/22/1996	pt recv vax in AM & the next day pt devel redness & swelling @ the inj site;this is 1 of 12 pt from this site to have an adverse rxn;									U	10/16/1996	10/17/1996	1		PVT	PVT	NONE	NONE		~ ()~~~In patient	896303040L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4968181~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968181~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0095660	03/06/1997	OH	56.0	56		F	10/22/1996	pt recv vax in the AM & the next day pt devel redness & swelling @ inj site;this is 1 of 12 pt from this site to have an adverse rxn;									U	10/16/1996	10/17/1996	1		PVT	PVT	NONE	NONE		~ ()~~~In patient	896303040L	1						2	Injection site hypersensitivity; Injection site oedema; Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4968181~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968181~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0095662	03/06/1997	WA				U	12/30/1996	pt recv vax & w/in 24hr of vax pt devel welt @ the inj site, diarrhea & flu like sx;this is 1 of 2 pt from this site to have an adverse exp p/vax;									U					PVT	PVT	unk	unk		~ ()~~~In patient	897010012L	1						1	Diarrhoea; Influenza; Injection site hypersensitivity	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095663	03/06/1997	WA				U	12/30/1996	pt recv vax & w/in 24hr of vax pt devel a welt @ the inj site, diarrhea & flu-like sx;this is 1 of 2 pt from this site to have an adverse rxn p/vax;									U					PVT	PVT	unk			~ ()~~~In patient	897010012L	1						1	Diarrhoea; Influenza; Injection site hypersensitivity	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095664	03/06/1997	CO	57.0	57		F	10/22/1996	pt recv flu vax & exp pain @ the inj site;pain radiated to shoulder & elbow, was unrelieved by APAP & advil & caused to have limited ROm of lt arm;this is 1 of 2 pt from this site to exp inj site pain p/vax;				Y					U	10/07/1996	10/07/1996	0		PUB	PUB	unk	unk		~ ()~~~In patient	897016010L	1						1	Hypokinesia; Injection site pain	FLU3~PFIZER\WYETH~4968165~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095665	03/06/1997	CO	57.0	57		F	10/22/1996	pt recv vax & exp pain @ inj site;pain was unrelieved w/advil, caused to have limited ROM of the lt arm;this is 1 of 2 pt from this site to exp inj site pain following receipt of vax;				Y					U	10/07/1996	10/09/1996	2		PUB	PVT	Advil	unk		pt has recv @ least 4 prev doses of flu vax w/o adverse exp;~ ()~~~In patient	897016011L	1						1	Hypokinesia; Injection site pain	FLU3~PFIZER\WYETH~4968165~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095666	03/06/1997	NY	65.0	65		F	10/29/1996	several days p/vax pt devel an inj site rxn characterized by redness & bruising which measured 3 by 4;				Y					U	10/11/1996	10/15/1996	4	22OCT96 CBC WNL;	PVT	PVT	Synthroid, Paxil, Lithium, Ambien, Colace, Metamucil;	NONE	thyroid disorder, depression, bipolar disorder, insomnia, constipation	~ ()~~~In patient	896310008L	1						1	Ecchymosis; Injection site hypersensitivity	FLU3~PFIZER\WYETH~4968170~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095667	03/06/1997	AZ	36.0	36		F	10/28/1996	1wk following vax pt devel gen itching, facial flushing, & arthralgia;									U	10/17/1996	10/24/1996	7		PVT	PVT	Prilosec;Azmacort inhaler;Serovent inhaler;Flexeril;Imitrex PRN	NONE		~ ()~~~In patient	896310010L	1						1	Arthralgia; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095668	03/06/1997	IL	38.0	38		M	10/30/1996	approx 1wk p/vax pt exp stomach cramps, low grade fever (99-100), myalgia, myasthenia, twitching of the chest & legs & soreness @ the balls of both feet;this is 1 of 2 pt from this site to have an adverse exp p/vax;									U	10/03/1996	10/11/1996	8		OTH	OTH	NONE	NONE		~ ()~~~In patient	896310013L	1						1	Abdominal pain; Arthralgia; Muscle twitching; Myalgia; Myasthenic syndrome; Pyrexia	FLU3~PFIZER\WYETH~4968192~3~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095669	03/06/1997	IL	36.0	36		F	10/28/1996	approx 1wk p/vax pt exp stomach cramps, low-grade fever (99-100), myalgia, myasthenia, twitching especially in legs, cheeks, & neck, & soreness @ the balls of both feet;this is 1 of 2 pt from site to have adverse exp p/vax;									U	10/03/1996	10/11/1996	8		OTH	OTH	NONE	NONE		~ ()~~~In patient	896310014L	1						1	Abdominal pain; Arthralgia; Muscle twitching; Myalgia; Myasthenic syndrome; Pyrexia	FLU3~PFIZER\WYETH~4968192~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095670	03/06/1997	IA				U	10/25/1996	w/in 24hr of vax pt had a positive breathalyzer test for alcohol;pt adamantly states that did not drink alcohol;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896310018L	1						1	Unevaluable event	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095672	03/06/1997	MI				U	10/25/1996	this is 1 of 2 pt from this site to devel an inj site rxn p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896311013L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095673	03/06/1997	OK	40.0	39		F	10/25/1996	w/in 2 hr of vax pt devel redness & swelling @ the inj site & swelling of the lt hand;redness & swelling @ the inj site have resolved but the hand remained swollen @ the date of this report;				Y					U	10/11/1996	10/11/1996	0		OTH	OTH	unspecified ulcer medication	unk	ulcer	~ ()~~~In patient	896311014L	1						1	Injection site hypersensitivity; Injection site oedema; Oedema peripheral	FLU3~PFIZER\WYETH~~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095674	03/06/1997	MN	33.0	33		M	10/24/1996	pt became lightheaded shortly p/vax;2hr later pt was still lightheaded;									U	10/24/1996	10/24/1996	0		OTH	OTH	unk	headache		~ ()~~~In patient	896311015L	1						1	Dizziness	FLU3~PFIZER\WYETH~4968205~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095675	03/06/1997	VA				U	10/30/1996	this is 1 of 4 pt, out of 35 to devel an inj site rxn, characterized by redness & itching, immed p/vax;pt also exp itching in the opposite arm;									U	10/29/1996	10/29/1996	0		OTH	OTH	unk	unk		~ ()~~~In patient	896312004L	1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095676	03/06/1997	VA				U	10/30/1996	this is 1 of 4 pt, out of 35pt pt devel an inj site rxn, characterized by redness & itching, immed p/vax;pt also exp itching in the opposite arm;									U	10/29/1996	10/29/1996	0		OTH	OTH	unk	unk		~ ()~~~In patient	896312005L	1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095677	03/06/1997	VA				U	10/30/1996	this is 1 of 4 pt, out of 35 to devel an inj site rxn, characterized by redness & itching, immed p/vax;									U	10/29/1996	10/29/1996	0		OTH	OTH	unk	unk		~ ()~~~In patient	896312006L	1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095678	03/06/1997	VA				U	10/30/1996	this is 1 of 4 pt, out of 35pt, to devel an inj site rxn characterized by redness & itching, immed p/vax;									U	10/29/1996	10/29/1996	0		OTH	OTH	unk	unk		~ ()~~~In patient	896312007L	1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095679	03/06/1997	PA	78.0	78		M	10/30/1996	approx 5 or 6 days p/vax pt devel gen red raised rash;following day papules appeared & were present @ the date of this report;									Y	10/22/1996	10/27/1996	5		OTH	OTH	Haldol	NONE	NKDA;thrompocytopenia coincident w/mellaril use;neurogenic bladder w/urostomy;dementia;	~ ()~~~In patient	896312008L	1						1	Rash maculo-papular	FLU3~PFIZER\WYETH~4968191~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095680	03/06/1997	MI	52.0	52		F	10/28/1996	w/in 5min p/vax pt became cold, clammy, nauseous;recovered w/in 10 to 15min;this is 1 of 3 pt from this site to devel these sx p/vax;									Y	10/22/1996	10/22/1996	0		PUB	PUB	unk	NONE		~ ()~~~In patient	896312010L	1						1	Asthenia; Chills; Hyperhidrosis; Nausea	FLU3~PFIZER\WYETH~4968191~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095681	03/06/1997	MI	23.0			M	10/28/1996	w/in 5min p/vax pt became cold, clammy, nauseous;pt recovered w/in 10 to 15min;this is 1 of 3 pt from this site to devel these sx following an inj;									Y	10/03/1996	10/03/1996	0		PUB	PUB	unk	NONE		~ ()~~~In patient	896323005L	1						1	Asthenia; Chills; Hyperhidrosis; Hypotension; Nausea; Pallor	FLU3~PFIZER\WYETH~4968183~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095682	03/06/1997	IN	29.0			M	10/28/1996	w/in 5min p/vax pt became cold, clammy, & nauseous;pt recovered w/in 10 to 15min;this is 1 of  3 pt from this site to devel these sx p/vax;									Y	10/26/1996	10/26/1996	0		PUB	PVT	unk	NONE		~ ()~~~In patient	896323006L	1						1	Chills; Dizziness; Hyperhidrosis; Nausea; Syncope	FLU3~PFIZER\WYETH~4968191~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095683	03/06/1997	MN	42.0	42		F	10/24/1996	pt recv vax & 15-20min later, devel an inj site rxn characterized by splotches & itching;									U	10/24/1996	10/24/1996	0		PVT	OTH	Ammonium lactate;cimetidine;beclommethasone;atenolol;loratadine;sertaline;nitrolgycerin;naproxen;albuterol inhaler	NONE	asthma, iodine allergy	~ ()~~~In patient	896312013L	1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095684	03/06/1997	NY	50.0	50		F	12/05/1996	pt devel an inj site rxn characterized by a 10cm area of erythema, warmth, & pruritus p/vax; this is 1 of 4 pt from this site to devel an inj site rxn p/vax;									Y	10/15/1996	10/15/1996	0		PVT	PVT	unk	NONE		~ ()~~~In patient	896352004L	1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4968191~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095685	03/06/1997	NY	30.0	30		F	10/23/1996	pt exp pain in the lt upper arm, lasting longer than 48hr p/vax;tx w/advil & recovered;this is 1 of 4 pt from this site to have an inj site rxn p/vax;									Y	10/15/1996	10/15/1996	0		PVT	PVT	Parlodel;allergy shot;proventil;claritin;	NONE	environmental allergies, asthma, pituitary adenoma	~ ()~~~In patient	896312017L	1						1	Pain	FLU3~PFIZER\WYETH~4968191~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095686	03/06/1997	NY	32.0	32		F	12/05/1996	pt exp pain in lt upper arm, lasting longer than 48hr p/vax;pt devel lt axillary lymphadenopathy;pt recovered @ the date of this report;this is 1 of 4 pt to devel an inj site rxn p/vax;									Y	11/21/1996				PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	896352003L	1						1	Lymphadenopathy; Pain	FLU3~PFIZER\WYETH~4968191~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095687	03/06/1997	NY	47.0	47		F	12/05/1996	pt devel an inj site rxn characterized by pain & swelling p/vax;pt recovered p/4 days;this is 1 of 4 pt from this site to develop an inj site rxn p/vax;									Y	10/21/1996	10/21/1996	0		PVT	PVT	InderalToprol	NONE	HTN	~ ()~~~In patient	896352002L	1						1	Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4968191~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095688	03/06/1997	TX				F	10/23/1996	pt recv vax & devel elevated blood glucose levels (20 points above baseline);no further info was available @ the date of this report;									U	10/17/1996	10/17/1996	0		OTH	OTH	unk	unk	diabetes mellitus (type not specified)	~ ()~~~In patient	896313002L	1						1	Hyperglycaemia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095689	03/06/1997	OH	25.0	25		F	10/24/1996	pt recv vax & devel an inj site rxn characterized by erythema & tenderness;also devel ax lymphadenopathy;									Y	10/18/1996	10/19/1996	1		PUB	OTH	Genoral; 1 A day vitamin	NONE		~ ()~~~In patient	896313004L	1						1	Injection site hypersensitivity; Injection site pain; Lymphadenopathy	FLU3~PFIZER\WYETH~4968204~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095690	03/06/1997	MN	35.0	35		F	10/24/1996	approx 2hr p/vax pt devel an area of numbness the size of a hand @ the inj site;									Y	10/24/1996	10/24/1996	0		OTH	PVT	NONE	NONE		~ ()~~~In patient	896313005L	1						1	Paraesthesia	FLU3~PFIZER\WYETH~4968205~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095691	03/06/1997	CA	50.0			F	10/31/1996	1 day p/vax pt devel angioedema & flu-like sx;addtl info recv 3DEC96, indicated that pt recovered;									Y	10/22/1996	10/23/1996	1		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	896313012L	1						1	Angioneurotic oedema; Influenza	FLU3~PFIZER\WYETH~~1~SC~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095692	03/06/1997	MO	53.0	53		F	10/31/1996	pt recv vax & devel neuropathy;addtl info was recv 2DEC96;1wk post vax pt exp numbness & arthralgia @ the inj site which radiated down arm;									Y	09/30/1996				OTH	OTH	ASA;Calcium carbonate, multivitamin;	chronic cough-etiology unk	NKA-mitral valve prolapse	~ ()~~~In patient	896313013L	1						1	Arthralgia; Injection site reaction; Neuropathy; Paraesthesia; Arthralgia; Neuropathy; Paraesthesia	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~1~IM~~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~~1~IM~~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0095693	03/06/1997	MN	53.0	53		F	10/30/1996	1 day p/vax pt devel an inj site rxn characterized by redness & swelling the size of a fruit jar lid;also felt flushed;									Y	10/29/1996	10/30/1996	1		OTH	OTH	Theodur;Proventil inhaler;Asmacort inhaler;	worsening asthma sx;	asthma;	~ ()~~~In patient	896313014L	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4968172~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095694	03/06/1997	MD	45.0	45		M	11/04/1996	24 to 48hr p/vax pt devel a rash w/papules on abd & bilat antecubital & popliteal areas;pt saw MD & was treated w/Valisone lotion;addtl info recv 17DEC96 indicated that pt recovered;				Y					Y	10/28/1996				PVT	OTH	NONE	NONE	allergy to sulfa	pt devel a similar rash in JAN96, 24-48 hr p/vax 95/96 flu~ ()~~~In patient	896316004L	1						1	Rash maculo-papular	FLU3~PFIZER\WYETH~4968147~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095695	03/06/1997	FL	49.0	49		M	10/30/1996	pt recv vax & exp pain @ inj site;tx w/compresses & non-steroidal anti-inflammatory agents w/o relief;pain was worsening @ the date of report;				Y					U	10/25/1996	10/26/1996	1		OTH	OTH	NONE	UNK		~ ()~~~In patient	896316008L	1						1	Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095696	03/06/1997	MT	38.0	38		F	10/30/1996	pt recv vax & devel an inj site rxn characterized by redness, swelling, warmth, & tenderness;pt was improving 48hr p/vax & given pneumococcal vax;				Y					U	10/26/1996				OTH	OTH	pt recv pneumococcal vax 28OCT96	unk		~ ()~~~In patient	896316010L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4968265~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095697	03/06/1997	ME				U	10/31/1996	pt devel swelling @ inj site p/vax;									U					PUB	OTH	unk	unk		~ ()~~~In patient	896317005L	1						1	Injection site oedema	FLU3~PFIZER\WYETH~4968173~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095698	03/06/1997	ME	52.0			F	10/31/1996	pt exp itching @ inj site immed following vax;									Y					PUB	OTH	unk	unk		~ ()~~~In patient	896317006L	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4968173~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095699	03/06/1997	TX				U	10/31/1996	pt recv vax & devel an inj site rxn characterized by redness & warmth;the reporter believed the inj may have been given ID;									U	10/29/1996				OTH	OTH	unk	unk		~ ()~~~In patient	896318002L	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095700	03/06/1997	IL	65.0	65		F	10/31/1996	pt recv vax in the fatty portion of upper arm not in deltoid muscle;2 days later pt devel redness, swelling, tenderness, & a hematoma @ inj site;									U	10/28/1996	10/30/1996	2		PVT	OTH	unk	unk		~ ()~~~In patient	896318003L	1						1	Injection site haemorrhage; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095701	03/06/1997	NJ				F	11/01/1996	pt recv vax & devel an inj site rxn characterized by a 6x4 area of redness, hardness & warmth;									U	10/30/1996				OTH	OTH	unk	NONE		this pt had recv prev doses of flu vax w/o adverse exp;~ ()~~~In patient	896318004L	1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095702	03/06/1997	PA	1.9	1	.9	M	10/31/1996	pt recv vax & devel a fever of 101.6 & an inj site rxn characherized by redness & swelling;the redness & swelling eventually extended from hip to calf;tx w/ATB & recovered;									Y	10/28/1996	10/29/1996	1		PVT	PVT	Solbid;Intal	NONE	asthma	pt exp swelling @ inj site @ 10mo w/flu vax dose 1;~ ()~~~In patient	896318005L	1						1	Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Pyrexia; Rash	FLU3~PFIZER\WYETH~4968204~3~IM~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095703	03/06/1997	OR	59.0	59		F	10/31/1996	pt recv vax & devel an inj site rxn charachterized by redness, swelling & pain;pt was seen in ER where sx were dx as an allerg rxn;				Y					Y	10/14/1996	10/15/1996	1		PUB	OTH	Glucophage;Accupril;Estrace;Glucotrol XL	NONE	diabetes mellitus;No allergies known;	~ ()~~~In patient	896318006L	1						1	Hypersensitivity; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4968167~7+~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095704	03/06/1997	MA	40.0	40		F	11/05/1996	pt devel a dull, constant h/a w/in 24hr of vax;h/a is unrelieved by Advil;									U	10/29/1996	10/29/1996	0		OTH	OTH	NONE	NONE		~ ()~~~In patient	896318012L	1						1	Headache	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095705	03/06/1997	PA	82.0	82		M	11/05/1996	2 to 3 days p/vax pt devel muscle & joint aches which have progressivley gotten worse;pt MD tentatively dx arthritis;pt has been treated 1st w/voltaren & then w/daypro w/o success;				Y					Y	10/01/1996	10/01/1996	0		OTH	OTH	unk	NONE		~ ()~~~In patient	896318013L	1						1	Arthralgia; Arthritis; Myalgia	FLU3~PFIZER\WYETH~~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095706	03/06/1997	CA				F	11/01/1996	pt recv vax & devel an inj site rxn characterized by erythema, swelling & pain;pt recovered;									Y	10/11/1996	10/11/1996	0		PVT	PVT	unk	NONE		~ ()~~~In patient	896318014L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4968158~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095707	03/06/1997	TX				F	11/07/1996	w/in 24hr of vax pt devel an inj site rxn characterized by redness & swelling which extended to the elbow;									U	11/05/1996	11/05/1996	0		PVT	OTH	unk	unk		~ ()~~~In patient	896318020L	1						1	Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Rash	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095708	03/06/1997	WA	79.0	79		M	11/06/1996	pt recv vax & stated that pt devel the flu w/cough, sore throat, & sore muscles;									Y	10/30/1996	10/31/1996	1		PUB	PUB	NONE	NONE		~ ()~~~In patient	896318021L	1						1	Cough; Influenza; Myalgia; Pharyngitis	FLU3~PFIZER\WYETH~~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095709	03/06/1997	OK	54.0	54		F	11/08/1996	pt recv vax & exp severe pain in the inj arm;the pain readiated to the neck;addtl info recv 26DEC96 indicated that the pain persisted for 12hr then resolved completely;				Y					Y	11/07/1996	11/07/1996	0		PUB	PVT	Lodine;Claritin;	NONE		~ ()~~~In patient	896318023L	1						1	Neck pain; Pain	FLU3~PFIZER\WYETH~4968192~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095710	03/06/1997	IN	43.0	43		F	10/23/1996	this is 1 of 2 hosp emp to devel an inj site rxn characterized by redness, swelling & warmth p/vax;the vax was administered between the shoulder & elbow areas but below the deltoid;									Y	10/21/1996	10/22/1996	1		OTH	OTH	unk	unk		~ ()~~~In patient	896320004L	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095711	03/06/1997	IL	54.0	54		F	10/23/1996	this is 1 of 2 hosp employees to deven an injs ite rxn characterized by redness, swelling & warmth, following vax;vaccine was administered between the shoulder & elbow areas but below the deltoid;									Y	10/15/1996	10/17/1996	2	none	OTH	OTH	unk	none		~ ()~~~In patient	896350001L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095712	03/06/1997	NJ	30.0	30		M	11/05/1996	4 days p/vax pt devel right-sided facial drooping for the upper eyelid to the mouth;				Y					N	10/22/1996	10/28/1996	6	CT scan of head and Lyme titer were negative	PVT	OTH	NONE	NONE		~ ()~~~In patient	896320005L	1						1	Facial palsy	FLU3~PFIZER\WYETH~4968149~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095713	03/06/1997	WI				F	11/12/1996	pt recv vax & tip of 1 finger of the rt hand became white & cold & hyperperfused;also had one episode of rectal bleeding;@ that time, bleeding time was 13min;all other hematologic & blood chem nl;devel small bruise, hemmorrhage rt eye;numb									Y				bleeding time was 13 minutes	PVT	PVT	NONE	none	thimerosal allergy	pt recv flu vax approx 8yr ago w/o adverse exp~ ()~~~In patient	896337014L	1						1	Bleeding time prolonged; Ecchymosis; Gastrointestinal haemorrhage; Laboratory test abnormal; Pallor; Paraesthesia; Peripheral vascular disorder; Vasodilatation	FLU3~PFIZER\WYETH~~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095714	03/06/1997	CA				U	11/07/1996	pt recv vax & had an unspecified adverse exp;no further info was abailable @ the dat eof this report;									U					OTH	OTH	iml	iml	cancer (type & stage unspecified)	~ ()~~~In patient	896337015L	1						1	Unevaluable event	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095715	03/06/1997	SC				U	10/31/1996	pt recv vax & devel rash @ inj site;the rash resolved spontaneously p/3 days;this is 1 of 3 pt from this site to devel rxn;									Y	10/01/1996	10/01/1996	0		PUB	OTH	unk	unk		~ ()~~~In patient	896312009L	1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095716	03/06/1997	SC				U	10/31/1996	this is 1 of 3 pt from this site to devel a rash @ the inj site p/vax;rash resolved spontaneously p/3 days;									Y	10/01/1996	10/01/1996	0		PUB	OTH	unk	unk		~ ()~~~In patient	896323007L	1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095717	03/06/1997	SC				U	10/31/1996	this is 1 of 3 pt from this site to devel a rash @ the inj site following vax;rash resolved spontaneously p/3 days;									Y	10/01/1996	10/01/1996	0		PUB	OTH	unk	unk		~ ()~~~In patient	896312009L	1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095718	03/06/1997	ID				U	10/24/1996	several pt from this site exp various sx including kidney pain, achiness, nausea, vomiting, & diarrhea p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896313010L	1						1	Diarrhoea; Myalgia; Pain; Vomiting	FLU3~PFIZER\WYETH~4968146~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095719	03/06/1997	ID				U	10/24/1996	several pt from site exp various sx including kidney pain, achiness, nausea, vomiting & diarrhea p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896313010L	1						1	Diarrhoea; Myalgia; Pain; Vomiting	FLU3~PFIZER\WYETH~4968146~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095720	03/06/1997	ID				U	10/24/1996	several pt from this site exp various sx including kidney pain, achiness, nausea, vomiting, & diarrhea p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896313010L	1						1	Diarrhoea; Myalgia; Pain; Vomiting	FLU3~PFIZER\WYETH~4968146~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095721	03/06/1997	ID				U	10/24/1996	several pt from this site exp various sx including kidney pain, achiness, nausea, vomiting & diarrhea p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896313010L	1						1	Diarrhoea; Myalgia; Pain; Vomiting	FLU3~PFIZER\WYETH~4968146~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095722	03/06/1997	ID				U	10/24/1996	several pt from this site exp various sx including kidney pain, achiness, nausea, vomiting & diarrhea p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896313010L	1						1	Diarrhoea; Myalgia; Pain; Vomiting	FLU3~PFIZER\WYETH~4968146~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095723	03/06/1997	ID				U	10/24/1996	several pt from this site exp various sx including kidney pain, achiness, nausea, vomiting & diarrhea p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896313010L	1						1	Diarrhoea; Myalgia; Pain; Vomiting	FLU3~PFIZER\WYETH~4968146~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095724	03/06/1997	CO				U	10/30/1996	this is 1 of 2 pt @ this site to devel a rash on the dorsal surface of both hands 1.5 wk p/vax;the rash consists blisters & pustules & the area bruised p/scratching;				Y					U					OTH	OTH	unk	unk		~ ()~~~In patient	896313011L	1						1	Dermatitis bullous; Ecchymosis; Pruritus; Rash; Dermatitis bullous; Ecchymosis; Pruritus; Rash	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0095724	03/06/1997	CO				U	10/30/1996	this is 1 of 2 pt @ this site to devel a rash on dorsal surface of both hands 1.5 wk p/vax;rash consists blisters & pustules, & the area bruised p/scratching;				Y					U					OTH	OTH	unk	unk		~ ()~~~In patient	896313011L	1						2	Dermatitis bullous; Ecchymosis; Pruritus; Rash; Dermatitis bullous; Ecchymosis; Pruritus; Rash	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0095726	03/06/1997	FL				U	11/06/1996	w/in 1 day of vax a few  pt devel redness & a nodule @ the inj site;no further info was available @ the date of this report;									U					PVT	OTH	unk	NONE		~ ()~~~In patient	896318022L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4968171~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095727	03/06/1997	FL				U	11/06/1996	w/in 1 day of vax a few pt devel redness & a nodule @ inj site;									U					PVT	OTH	unk	NONE		~ ()~~~In patient	896318022L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4968171~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095728	03/06/1997	FL				U	11/06/1996	w/in 1 day of vax a few pt devel redness & a nodule @ inj site;									U					PVT	OTH	unk	NONE		~ ()~~~In patient	896318022L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4968171~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095729	03/06/1997	CA				U	11/15/1996	pt recv vax & had an unspecified adverse exp;no further info was available @ the date of this report;									U					OTH	OTH	unk	unk	lupus	~ ()~~~In patient	896337016L	1						1	Unevaluable event	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095735	03/06/1997	OR	33.0	33		M	11/08/1996	pt recv vax & later that day pt devel a cough productive for dark sputum, dry throat, nasal congestion &  a feverish feeling (actual temp unk);self-tx w/a multivitamin & was feeling better @ the date of this report;									U	11/04/1996	11/04/1996	0		OTH	OTH	unk	unk		~ ()~~~In patient	896337019L	1						1	Cough; Dry mouth; Pyrexia; Rhinitis	FLU3~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095736	03/06/1997	IN	40.0	40		F	11/13/1996	2 days p/vax pt devel an itchy, papular rash on the scalp;the rash spread to shoulders, back, chest, & arms;tx w/medrol dosepak;when the medrol was discontinued, the rash returned;									Y	10/24/1996	10/31/1996	7		PVT	PVT	Synthroid;Prozac, oral contraceptive, vitamins	NONE		~ ()~~~In patient	896337020L	1						1	Pruritus; Rash maculo-papular	FLU3~PFIZER\WYETH~4968189~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095737	03/06/1997	MD				U	11/13/1996	the reporter stated that an unk number of patients devel an inj site rxn, including rash @ inj site, p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896337022L	1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095738	03/06/1997	WA				U	11/05/1996	this is 1 of 6 pt from this site of devel flu-like sx & diarrhea 10-14 days p/vax;									U					PVT	OTH	unk	unk		~ ()~~~In patient	896337023L	1						1	Diarrhoea; Influenza	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095739	03/06/1997	WA				F	11/05/1996	this is 1 of 6 pt from this site to devel flu-like sx & diarrhea 10-14 days p/vax;									Y	10/30/1996	11/05/1996	6		PVT	OTH	unk	unk		~ ()~~~In patient	896352015L	1						1	Back pain; Diarrhoea; Headache; Influenza; Myalgia; Otitis media; Pharyngitis; Pruritus	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095740	03/06/1997	WA	83.0			F	11/05/1996	this is 1 of 6 pt from this site to devel flu-like sx & diarrhea 10-14 days p/vax;									Y	10/23/1996	11/05/1996	13		PVT	OTH	unk	unk		~ ()~~~In patient	896352016L	1						1	Chills; Diarrhoea; Influenza; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095741	03/06/1997	WA	83.0			M	11/05/1996	this is 1 of 6 pt from this site to devel flu-like sx & diarrhea 10-14 days p/vax;									Y	10/18/1996	11/05/1996	18		PVT	OTH	unk	unk		~ ()~~~In patient	896352017L	1						1	Diarrhoea; Dyspepsia; Influenza; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095742	03/06/1997	WA	65.0			M	11/05/1996	this is 1 of 6 pt from this site to devel flu-like sx & diarrhea 10-14 days p/vax;									Y	10/22/1996	10/23/1996	1		PVT	OTH	unk	unk		~ ()~~~In patient	896352018L	1						1	Diarrhoea; Headache; Influenza; Palpitations; Rhinitis	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095743	03/06/1997	WA				U	11/05/1996	this is 1 of 6 pt from this site to devel flu-like sx & diarrhea 10-14 days p/vax;									U					PVT	OTH	unk	unk		~ ()~~~In patient	896352019L	1						1	Diarrhoea; Influenza	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095745	03/06/1997	MA	46.0	46		F	11/13/1996	1 day p/vax pt devel an inj site rxn characterized by a 6cm by 8cm area of redness & swelling;									Y	11/12/1996	11/13/1996	1		PVT	PVT	NONE	NONE		~ ()~~~In patient	896338002L	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4968139~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095746	03/06/1997	OH	48.0	48		F	11/26/1996	1 day p/vax pt exp pain & numbness from shoulder joint to fingers of the lt arm;pt is under the care of a MD & physical therapist;pt claims to be unable to work because of this;				Y					U	10/11/1996	10/12/1996	1		PUB	PUB	NONE	NONE		pt has recv 8 prev doses of flu vax w/o adverse exp~ ()~~~In patient	896338003L	1						1	Pain; Paraesthesia	FLU3~PFIZER\WYETH~4968191~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095747	03/06/1997	PA	39.0	39		F	11/26/1996	pt recv vax & devel a pruritic rash on eyelids, neck, trunk, arms & legs;pt had begun taking Calan SR on 4SEP96;when the rash devel the Calan SR was discontinued, but the rash persisted;				Y					Y	09/30/1996	09/30/1996	0	1984: RAST test reactive to egg white;	PVT	OTH	Tenormin;Calan SR	NONE	HTN, egg allergy;	~ ()~~~In patient	896338005L	1						1	Eczema; Pruritus; Rash	FLU3~PFIZER\WYETH~4968173~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095748	03/06/1997	MO				U	11/25/1996	1 day following vax pt devel an inj site rxn characterized by pain, redness, & swelling;the area around inj site oozed & then scabbed;pt had recovered @ the date of this report;									Y	11/05/1996	11/06/1996	1		PVT	OTH	unk	unk		~ ()~~~In patient	896338007L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095749	03/06/1997	MA	45.0	45		F	11/21/1996	pt recv vax & devel sudden onset of SOB, vomiting, diarrhea & pruritus;pruritus persisted @ the date of this report (2 days post vax);				Y					U	10/18/1996	10/20/1996	2		OTH	OTH	unk	unk		~ ()~~~In patient	896338010L	1						1	Diarrhoea; Dyspnoea; Pruritus; Vomiting	FLU3~PFIZER\WYETH~4968173~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095750	03/06/1997	KS	45.0	45		F	11/22/1996	w/in 1hr of vax pt exp tenderness @ the inj site;pt devel an inj site rxn characterized by redness, induration & warmth;pt believes the inj was given subcutaneous;									U	11/18/1996	11/18/1996	0		OTH	PVT	NONE	NONE		~ ()~~~In patient	896338011L	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~~4~SC~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095751	03/06/1997	FL	31.0	31		F	11/08/1996	pt recv vax & devel an inj site rxn characterized by redness & tenderness;no further info was available @ the date of this report;this is 1 of 3 employees from this site to have an adverse exp following receipt of vax;									Y	11/07/1996	11/07/1996	0		OTH	OTH	none	none	none	~ ()~~~In patient	896351016L	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4968203~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095752	03/06/1997	FL	55.0	55		F	11/08/1996	w/in 15min of vax pt devel an inj site rxn characterized by redness, warmth, & tenderness;pt devel gen hives, treated self w/oral DPH & recovered;this is 1 of 3 employees of this facility to have adverse exp p/vax;									Y	11/07/1996	11/07/1996	0		OTH	OTH	unk	unk		this pt recv @ least 1 prev dose of flu vax w/o adverse exp;~ ()~~~In patient	896338019L	1						1	Dyspnoea; Injection site hypersensitivity; Injection site oedema; Injection site pain; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4968203~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095753	03/06/1997	FL	31.0	31		F	11/08/1996	pt recv vax & devel an inj site rxn characterized by redness & tenderness;this is 1 of 3 employees from this site to have an adverse exp following vax;									U	11/07/1996	11/07/1996	0		OTH	OTH	unk	unk		~ ()~~~In patient	896338020L	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4968203~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095755	03/06/1997	WI	50.0	50		F	11/21/1996	this is 1 of 3 pt from this site to devel a red rash @ inj site p/vax;									Y	11/13/1996				PVT	OTH	unk	unk		~ ()~~~In patient	896339010L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4968139~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095756	03/06/1997	WI	25.0	25		F	11/21/1996	this is 1 of 3 pt from this site to devel a red rash @ the inj site p/vax;									Y	11/18/1996	11/20/1996	2	none	PVT	OTH	none	none	none	~ ()~~~In patient	896350006L	1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~4968139~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095757	03/06/1997	WI	29.0	29		F	11/21/1996	this is 1 of 3 pt from this site to devel a red rash @ inj site p/vax;									Y	11/19/1996	11/20/1996	1		PVT	OTH	unk	none	none	~ ()~~~In patient	896350007L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4968139~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095758	03/06/1997	NE	37.0	37		F	11/07/1996	this is 1 of 5 pt @ this site to have an unspecified adverse exp p/vax;									Y	10/22/1996	10/22/1996	0	none	PUB	PVT	Zestril - oral	cold	hypertension; allergies: penicillin, sulfa, wheats, mold, dust, environmental	~ ()~~~In patient	896346006L	1						1	Arthralgia; Asthenia; Injection site oedema; Nausea; Oedema peripheral; Pain; Pyrexia; Arthralgia; Asthenia; Injection site oedema; Nausea; Oedema peripheral; Pain; Pyrexia	FLU3~PFIZER\WYETH~4968172~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968172~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0095758	03/06/1997	NE	37.0	37		F	11/07/1996	this is 1 of 5 employees @ this site to have an unspecified adverse exp p/vax;									Y	10/22/1996	10/22/1996	0		PUB	PVT	unk	unk		~ ()~~~In patient	896346006L	1						2	Arthralgia; Asthenia; Injection site oedema; Nausea; Oedema peripheral; Pain; Pyrexia; Arthralgia; Asthenia; Injection site oedema; Nausea; Oedema peripheral; Pain; Pyrexia	FLU3~PFIZER\WYETH~4968172~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968172~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0095760	03/06/1997	NE				U	11/07/1996	this is 1 of 5 employees @ this site to have an unspecified adverse exp p/vax;									U					PUB	PVT	unk	unk		~ ()~~~In patient	896346007L	1						1	Unevaluable event	FLU3~PFIZER\WYETH~4968172~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095761	03/06/1997	NE	21.0	21		F	11/07/1996	this is 1 of 5 employees @ this site to have an unspecified adverse exp p/vax;									Y	10/22/1996	10/22/1996	0		PUB	PVT	unk	none	chronic fatigue syndrome	~ ()~~~In patient	896346008L	1						1	Injection site oedema; Injection site pain; Oedema peripheral	FLU3~PFIZER\WYETH~4968172~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095762	03/06/1997	NE	56.0	56		F	11/07/1996	this is 1 of 5 employees @ this site to have an unspecified adverse exp following vax;									Y	10/22/1996	10/23/1996	1	none	PUB	PVT	unk	none	none	~ ()~~~In patient	896346009L	1						1	Anorexia; Back pain; Headache; Injection site pain; Myalgia; Nausea	FLU3~PFIZER\WYETH~4968172~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095763	03/06/1997	SC				U	11/14/1996	several pt from this site devel an inj site rxn following vax;no further info was available @ the date of this report;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896337018L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095764	03/06/1997	SC				U	11/14/1996	several pt from this site devel an inj site rxn following vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896337018L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095765	03/06/1997	SC				U	11/14/1996	several pt from this site devel an inj site rxn following vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896337018L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095766	03/06/1997	SC				U	11/14/1996	several pt from this site devel an inj site rxn p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896337018L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095767	03/06/1997	SC				U	11/14/1996	several pt from this site devel an inj site rxn p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896337018L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095768	03/06/1997	SC				U	11/14/1996	several pt from this site devel an inj site rxn p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896337018L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095769	03/06/1997	IL	77.0	77		M	12/04/1996	1 day p/vax pt devel fever up to 103.8, joint pains, severe h/a, back pain, a very dry cough;despite the administration of APAP, temp 2 days post vax inc to 104 & exp malaise;									Y	11/26/1996	11/27/1996	1	none	OTH	OTH	Cardizem cd, Prilosec	none	hypertension and reflkux esophagitis	~ ()~~~In patient	896347007L	1						1	Arthralgia; Back pain; Cough; Headache; Malaise; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095770	03/06/1997	MO				M	12/10/1996	this hosp employee recv vax & devel spider-like rash or bites on rt arm;these pruritic, bite-like marks then spread to lt arm, abd, upper thighs;									U	10/16/1996	10/16/1996	0	CBC done on 3 occassions since vaccination (dates not specified);WBC were 25,000;35,000; and 34,800;	OTH	OTH	NONE	NONE		~ ()~~~In patient	896350009L	1						1	Leukocytosis; Pruritus; Rash	FLU3~PFIZER\WYETH~4968169~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095771	03/06/1997	WI	31.0			M	12/10/1996	p/vax pt exp pain @ inj site; 2 days p/vax pt devel a h/a & pain @ the back of the head & neck which were unrelieved w/APAP;the 6th & 7th day post vax & was unable to sleep d/t h/a;seen in ER on 6NOV;see by MD poss inflammation of brain;				Y					U	10/30/1996	10/30/1996	0	CT scan of the head-96% certain to tumor or aneurysm;	PUB	OTH	unk	NONE		~ ()~~~In patient	896351006L	1						1	Delirium; Headache; Injection site pain; Insomnia; Neck pain	FLU3~PFIZER\WYETH~4968152~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095772	03/06/1997	IL	68.0	68		F	12/04/1996	1 day p/vax pt devel fever up to 103.8, joint pains, severe headache, back pain, & a very dry hard cough;									Y	11/26/1996	11/26/1996	0	none	OTH	OTH	none	none	none	~ ()~~~In patient	896351010L	1						1	Arthralgia; Back pain; Cough; Headache; Hyperacusis; Pyrexia; Rhinitis	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095773	03/06/1997	CO	70.0	70		F	11/22/1996	pt devel pain @ inj site approx 2 days p/vax;pain was described as mild to moderate for 1.5 wk, & then became more intense;pt exp inc pain when lifting lt arm, & when reaching out & front;exp some relief p/Ibuprofen;seen by MD;				Y					U	10/04/1996	10/06/1996	2		PUB	PUB	unk	unk		~ ()~~~In patient	896351017L	1						1	Hypokinesia; Injection site pain	FLU3~PFIZER\WYETH~4968165~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095774	03/06/1997	PA	49.0	49		F	12/11/1996	9 days p/vax pt devel an area of necrosis near the site of vax;this area of necrosis was encircled by a red ring;tx w/pred for 1 wk w/mild reduction of the inflammation;then tx w/ATB;western blot test for lyme disease was positive;				Y					Y	10/16/1996	10/25/1996	9	western blot test for lyme disease was positive;	PUB	OTH	Redux;premarin;	NONE		~ ()~~~In patient	896353001L	1						1	Infection; Rash; Skin necrosis; Vasodilatation	FLU3~PFIZER\WYETH~~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095776	03/06/1997	CA	59.0	59		F	11/04/1996	pt recv vax & was inadvertently re-vaccinated on 31OCT96;1NOV96 pt devel swelling @ the site of vax, disorientation & confusion w/h/a feeling;4NOV96 devel kidney pain as well as pain in lt arm & leg;pt exp diff walking d/t pain;									U	10/31/1996	11/01/1996	1		OTH	OTH	ASA;Synthroid;	unk	hypothyroidism, pulmonary embolism;	~ ()~~~In patient	896353007L	1						1	Confusional state; Gait disturbance; Headache; Hypokinesia; Injection site oedema; Pain; Renal pain; Arthralgia; Back pain; Confusional state; Dizziness; Gait disturbance; Injection site hypersensitivity; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~~2~IM~LA~PNEUMO (PNU-IMUNE)~1|FLU3~CONNAUGHT LABORATORIES~6F71247~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~431803~2~IM~LA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0095777	03/06/1997	PA	68.0	68		M	12/16/1996	1 day p/vax pt exp itching of the palms;2 days post vax pt devel a red rash on rt wrist;3 days post vax pt devel hives behind both knees & in the groin area;hives recur approx every 3 days;pt being tx w/DPH;				Y					U	10/27/1996	10/28/1996	1		PUB	OTH	NONE	NONE		~ ()~~~In patient	896353009L	1						1	Pruritus; Rash; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095778	03/06/1997	CA	27.0	27		F	12/17/1996	immed p/vax pt devel inj site rxn characterized by induration & erythema;pt recovered @ the date of this report;this is 1 of 4 pt from this site to devel an inj site rxn following vax;									Y	11/11/1996	11/11/1996	0	NONE	PVT	PVT	Zoloft;Synthroid;Desyrel	unk		~ ()~~~In patient	896355011L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4968162~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095779	03/06/1997	CA	49.0	49		F	12/17/1996	2 days p/vax pt devel an inj site rxn characterized by 45mm by 40mm area of erythema & induration;pt recovered @ the date of this report;this is 1 of 4 pt from this site to devel an inj site rxn following the vax;									Y	11/11/1996	11/13/1996	2	NONE	PVT	PVT	Propulcid	NONE	fibromyalgia	~ ()~~~In patient	896355012L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4968162~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095780	03/06/1997	CA	49.0	49		F	12/17/1996	w/in 30min of vax pt devel a 40mm by 30mm area of induration @ inj site;pt had recovered @ the date of this report;this is 1 of 4 pt from this site to devel an inj site rxn p/flu vax;									Y	11/12/1996	11/12/1996	0	NONE	PVT	PVT	Claritin D	NONE	NONE	~ ()~~~In patient	896355013L	1						1	Injection site mass	FLU3~PFIZER\WYETH~4968162~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095781	03/06/1997	CA	40.0	40		F	12/17/1996	w/in 4hr p/vax pt devel an inj site rxn characterized by an area of erythema & induration measuring 50mm in diameter;pt had recovered @ the date of this report;this is 1 of 4 pt from this site to devel an inj site rxn p/flu vax;									Y	11/10/1996	11/10/1996	0	NONE	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	896355014L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4968162~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095782	03/06/1997	CO				U	12/19/1996	pt recv vax & subsequently devel red, itchy eyes;no further info was available @ the date of this report;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896361004L	1						1	Conjunctivitis; Pruritus	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095783	03/06/1997	WA	42.0	42		F	12/18/1996	2 days p/vax pt exp flu-like sx & pain in both knees;the flu-like sx resolved w/symptomatic tx, but rt knee pain & lt knee burning persisted @ the date of this report;									U	10/16/1996	10/18/1996	2		OTH	OTH	NONE	NONE		~ ()~~~In patient	896361006L	1						1	Arthralgia; Influenza	FLU3~PFIZER\WYETH~~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095784	03/06/1997	NY	34.0	34		M	12/20/1996	1 day p/vax pt devel a rash & swelling @ inj site;2 days post vax the swelling inc & the area was hot to touch;pt also exp numbness & tingling in lt arm, pain ulnar nerve diff, & gen muscle & joint aches;tx w/meds;									U	10/25/1996	10/26/1996	1		PVT	PVT	NONE	sl throat redness		~ ()~~~In patient	896361005L	1						1	Arthralgia; Injection site hypersensitivity; Injection site oedema; Myalgia; Neuropathy; Pain; Paraesthesia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71246~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0095785	03/06/1997	LA				M	12/19/1996	pt recv vax & devel an inj site rxn consisting of a possible sterile abscess;no further info was available @ the date of this report;									U					OTH	PVT	unk	unk		~ ()~~~In patient	896361007L	1						1	Abscess; Injection site hypersensitivity	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095786	03/06/1997	IL	35.0			F	10/14/1996	pt inadvertently recv 1ml of flu vax instead of .5ml;2 days p/vax pt devel a fever of 102, sore throat & flu sx;addtl info recv 13NOV96,indicated that the pt recovered;@ that time the reporter stated that the pt husband devel similar sx;									Y	10/09/1996	10/11/1996	2		OTH	OTH	NONE	NONE		~ ()~~~In patient	896295019L	1						1	Influenza; Pharyngitis; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095787	03/06/1997	NC	26.0			F	10/02/1996	1 day p/vax pt devel an inject site rxn characterized by redness, warmth, & swelling;this is one of three employees from this site to devel an inj site rxn p/flu vax;									U	10/01/1996	10/02/1996	1		OTH	PVT	unk	NONE		~ ()~~~In patient	896277003L	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4968140~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095788	03/06/1997	NC	28.0			F	10/02/1996	1 day p/vax pt devel an inj site rxn characterized by redness, warmth, & swelling;this is one of three employees from this site to devel an inj site rxn p/vax;									U	10/01/1996	10/02/1996	1		OTH	PVT	unk	NONE		~ ()~~~In patient	896277005L	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4968140~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095789	03/06/1997	NC	40.0			F	10/02/1996	1 day p/vax pt devel an inj site rxn characterized by redness, warmth, & swelling;this is one of three employees from this site to devel an inj site rxn p/flu vax;									U	10/01/1996	10/02/1996	1		OTH	PVT	unk	NONE		~ ()~~~In patient	896277006L	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4968140~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095790	03/06/1997	NC	32.0			F	10/02/1996	pt exp pain @ the time of flu vax;that evening pain worsened & swelling devel @ the inj site;the next day site was very itchy;this event had mostly resolved @ the date of this report;									Y	09/20/1996	09/20/1996	0		PVT	PVT	Decadron	unk		~ ()~~~In patient	896278015L	1						1	Injection site oedema; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~~3~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095791	03/06/1997	MI				U	10/01/1996	this is one of 4 individuals out of 25 vaccines to devel a red, hard not @ the inj site p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896278016L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4968178~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095792	03/06/1997	MI				U	10/01/1996	this is one of 4 individuals, out of 25 vaccines, to devel a red, hard knot @ the inj site following receipt of flu vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896289003L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4968178~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095793	03/06/1997	MI				U	10/01/1996	this is one of 4 individuals, out of 25 vaccines to devel a red, hard knot @ the inj site p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896289004L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4968178~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095794	03/06/1997	MI				U	10/01/1996	this is one of 4 individuals, out of 25 vaccines, to devel a red, hard knot @ the inj site following vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896289005L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4968178~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095795	03/06/1997	MO	68.0	68		F	10/03/1996	1 day post vax pt awoke w/runny nose & a yellow nasal discharge;tx w/erythromycin & extendryl SR;									U	09/11/1996	09/12/1996	1		PVT	OTH	Synthroid;Premarin;Provera;Folic acid	NONE	polymyalgia rheumatica dx 2 yr ago;	~ ()~~~In patient	896281008L	1						1	Rhinitis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095796	03/06/1997	TN	42.0	42		F	10/04/1996	this is one of 2 hosp employees to devel a 10cm area of swelling, pain, warmth & a nodule @ site of flu vax;pt also exp gen aching, malaise, & diarrhea;diarrhea persisted for 72 hr;pt was seen in ER & tx w/DPH & ice;									Y	10/03/1996	10/03/1996	0		PVT	PUB	NONE	NONE	asthma	pt devel an inj site rxn p/vax;~ ()~~~In patient	896285008L	1						1	Diarrhoea; Injection site mass; Injection site oedema; Injection site pain; Malaise; Myalgia; Vasodilatation	FLU3~PFIZER\WYETH~4968176~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095797	03/06/1997	TN	37.0	37		F	10/04/1996	this is one of two hosp employees to devel a 10cm area of swelling, pain, warmth & a nodule @ the site of flu vax;2 days p/vax pt devel nausea & vomiting which persisted for 2 days;pt was seen in the Er & tx w/oral & IM Phenergan;				Y					Y	10/03/1996	10/03/1996	0		PVT	PUB	Estraderm	NONE	NONE	see # 95796~ ()~~~In patient	896285009L	1						1	Injection site mass; Injection site oedema; Injection site pain; Nausea; Vasodilatation; Vomiting	FLU3~PFIZER\WYETH~4968176~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095798	03/06/1997	OH	47.0	47		F	10/04/1996	pt recv vax & exp nausea, dizziness & felt as though was going to faint;next day devel a 5cm by 6cm area of redness, swelling, & warmth @ inj site;also exp inj site pain which radiated to wrist;devel rash;									Y	10/01/1996	10/01/1996	0	no vaccine was returned for inspection;retention samples were examined & found to be satisfactory;batch recrods were reviewed & found to be satisfactory;	PVT	PVT	Climara patch;Ativan;Vitamin B12;Dyzaide;Adipex;	NONE		~ ()~~~In patient	896288040L	1						1	Dizziness; Injection site hypersensitivity; Injection site oedema; Injection site pain; Nausea; Rash; Syncope; Vasodilatation	FLU3~PFIZER\WYETH~4968139~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095799	03/06/1997	TX	45.0	45		F	10/10/1996	pt recv .25ML of flu vax instead of .5ML;20 min p/vax pt exp SOB, chest pain, & thick tongue;pt took epi & went to ER where pt was noted to be in mild-to-moderate resp distress w/sl wheezing upon forced expiration;dx anaphylactic rxn to vax				Y					U	10/10/1996	10/10/1996	0		OTH	OTH	Unspecified inhaler;stadol nasal spray;darvocet N100;	unk	asthma;allergic rhinitis;unable to tolerate hep B vax;other allergies, including darvaon, demerol, ASA, & codeine;	~ ()~~~In patient	896292008L	1						1	Anaphylactoid reaction; Asthma; Chest pain; Dyspnoea; Respiratory disorder; Tongue oedema	FLU3~PFIZER\WYETH~4968161~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095800	03/06/1997	CA	24.0	24		F	10/11/1996	pt recv flu vax but also inadvertently recv another inj of flu shield intradermally;pt devel pain & redness @ the site of intradermal inj;addtl info was recv 6NOV96;pt was treated w/cortisone cream & resolved;									Y	10/09/1996	10/10/1996	1		MIL	PVT	unk	NONE		~ ()~~~In patient	896295001L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4968161~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095801	03/06/1997	MN	44.0	44		F	10/11/1996	1hr p/vax pt exp tenderness @ inj site;p/a couple of hr pt devel h/a, malaise, & nausea which persisted @ the date of this report;									U	10/04/1996	10/04/1996	0		OTH	PUB	Advil, Premarin, Prozac, Ritalin, Zantac	NONE		~ ()~~~In patient	896295002L	1						1	Headache; Injection site pain; Malaise; Nausea	FLU3~PFIZER\WYETH~~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095802	03/06/1997	TX	32.0	32		F	10/11/1996	3hr p/vax the area under this pt necklace became very itchy;that evening pt devel a low-grade fever & a band of hives around neck;the next day pt had a fever up to 101 & a red warm knot @ the inj site;									Y	10/09/1996	10/09/1996	0		OTH	OTH	rITALIN	none	TETANUS, BETADINE ALLERGIES	~ ()~~~In patient	896295004L	1						1	Injection site hypersensitivity; Injection site mass; Pruritus; Pyrexia; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095803	03/06/1997	NY				U	10/09/1996	the reporter stated that several pt devel inj site rxn characterized by redness, itching & swelling w/in 3hr of vax;									Y	10/07/1996	10/07/1996	0		PVT	OTH	unk	unk		~ ()~~~In patient	896295007L	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4968200~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095804	03/06/1997	NY				U	10/09/1996	the reporter stated that several pt devel inj site rxn characterized by redness, itching & swelling w/in 3hr of vax;									Y	10/07/1996	10/07/1996	0		PVT	OTH	unk	unk		~ ()~~~In patient	896295007L	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4968200~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095805	03/06/1997	NY				U	10/09/1996	the reporter stated that several pt devel inj site rxn characterized by redness, itching, & swelling w/in 3 hr of vax;									Y	10/07/1996	10/07/1996	0		PVT	OTH	unk	unk		~ ()~~~In patient	896295007L	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4968200~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095806	03/06/1997	NY				U	10/09/1996	the reporter stated that several pt devel inj site rxn characterized by redness, itching, & swelling w/in 3 hr of vax;									Y	10/07/1996	10/07/1996	0		PVT	OTH	unk	unk		~ ()~~~In patient	896295007L	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4968200~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095807	03/06/1997	NY				U	10/09/1996	reporter states that several pt devel inj site rxn characterized by redness, itching, & swelling w/in 3hr of vax;									Y	10/07/1996	10/07/1996	0		PVT	OTH	unk	unk		~ ()~~~In patient	896295007L	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4968200~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095808	03/06/1997	NY				U	10/09/1996	the reporter stated that several pt devel inj site rxn characterized by redness, itching, & swelling w/in 3hr of vax;									Y	10/07/1996	10/07/1996	0		PVT	OTH	unk	unk		~ ()~~~In patient	896295007L	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4968200~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095809	03/06/1997	OH				U	10/02/1996	reporter stated that several pt have devel inj site rxn consisting of large, red, raised, warm areas & tenderness following vax;									U				no vaccine was returned for inspection;retention samples were examined & found to be satisfactory;batch records were reviewed & found to be satisfactory;	PVT	PVT	unk	NONE		~ ()~~~In patient	896283007L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4968139~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095810	03/06/1997	OH				U	10/02/1996	the reporter states that several pt have devel inj site rxn consisting of large, red, raised, warm areas & tenderness p/vax;									U				no vaccine was returned for insepction;retention samples were examined & found to be satisfactory;batch records were reviewed & found to be satisfactory;	PVT	PVT	unk	NONE		~ ()~~~In patient	896283007L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4968139~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095811	03/06/1997	OH				U	10/02/1996	the reporter stated that several pt have devel inj site rxn consisting of large, red, raised, warm areas & tenderness following vax;									U				no vaccine was returned for inspection;retention samples were examined & found to be satisfactory;batch records were reviewed & found to be satisfactory;	PVT	PVT	unk	NONE		~ ()~~~In patient	896283007L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4968139~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095812	03/06/1997	OH				U	10/02/1996	reporter stated that several pt have devel inj site rxn consisting of large, red, raised, warm areas & tenderness p/vax;									U				no vaccine was returned for inspection;retention samples were examined & found to be satisfactory;batch records were reviewed & found to be satisfactory;	PVT	PVT	unk	NONE		~ ()~~~In patient	896283007L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4968139~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095813	03/06/1997	OH				U	10/02/1996	reporter stated that several pt have devel inj site rxn consisting of large, red, raised, warm areas & tenderness p/vax;									U				no vaccine was returned for inspection;retention samples were examined & found to be satisfactory;batch records were reviewed & found to be satisfactory;	PVT	PVT	unk	NONE		~ ()~~~In patient	896283007L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4968139~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095814	03/06/1997	OH				U	10/02/1996	reporter stated that several pt have devel inj site rxn consisting of large, red, raised, warm areas & tenderness p/vax;									U				No vaccine was returned for inspection;retention samples were examined & found to be satisfactory;batch records were reviewed & found to be satisfactory;	PVT	PVT	unk	NONE		~ ()~~~In patient	896283007L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4968139~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095815	03/06/1997	LA	34.0	34		F	10/14/1996	out of 35 vaccines this is 1 of 3 pt from this site to exp lightheadedness, dizziness & weakness w/in min of vax;pt was eval in ER;				Y					Y	10/14/1996	10/14/1996	0		OTH	OTH	unk	NONE		~ ()~~~In patient	896296008L	1						1	Asthenia; Dizziness; Headache	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095816	03/06/1997	LA	62.0	61		F	10/14/1996	out of 35 vaccines, this is one 1 of 3 pt from this site to exp lightheadedness, dizziness & weakness w/in minutes of vax;									Y	10/14/1996	10/14/1996	0		OTH	OTH	unk	NONE		~ ()~~~In patient	896296009L	1						1	Asthenia; Dizziness; Nausea	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095817	03/06/1997	LA				U	10/14/1996	out of 35 vaccines, this is 1 of 3 pt from this site to exp lightheadedness, dizziness, & weakness w/in min of vax;									U	10/14/1996	10/14/1996	0		OTH	OTH	unk	NONE		~ ()~~~In patient	896296010L	1						1	Asthenia; Dizziness	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095818	03/06/1997	CA	63.0	63		F	10/15/1996	pt devel fever & shaking 24-48 hr p/vax;5 days p/vax pt liver function tests were elevated;no further info was available @ the date of this report;									U	10/02/1996	10/03/1996	1	7OCT96 LFT's=81 (pt baseline 30-35);	PVT	PVT	Mevacor, Metformin, Zestril, Tolinase, Verapamil SR	NONE	type ii diabetes mellitus, HTN	~ ()~~~In patient	896296011L	1						1	Hepatic function abnormal; Laboratory test abnormal; Pyrexia; Tremor	FLU3~PFIZER\WYETH~4968137~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095819	03/06/1997	FL				F	10/16/1996	pt devel pruritic rash on chest & abd 3 days p/vax;pt also exp flu-like sx for a few days;pt recovered as of the date of this report;this is one of 4 pt from this site to have an adverse exp p/flu vax;									Y	10/11/1996	10/14/1996	3		OTH	PVT	NONE	NONE	PCN allergy	~ ()~~~In patient	896296020L	1						1	Influenza; Pruritus; Rash	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095820	03/06/1997	FL				F	10/16/1996	pt devel a pruritic rash on chest & abd 1 day p/vax;pt recovered as of the date of this report;this is one of four pt from this site to have an adverse exp p/flu vax;									Y	10/09/1996	10/10/1996	1		OTH	PVT	NONE	NONE	NKA	~ ()~~~In patient	896296021L	1						1	Pruritus; Rash	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095821	03/06/1997	FL				M	10/16/1996	this pt devel a fever, chills, & a sore throat which persisted for 4 days p/vax;pt had recovered as of the date of this report;this is one of four pt from this site to have an adverse exp following receipt of flu vax;									Y	10/12/1996				OTH	PVT	NONE	NONE	NKA	~ ()~~~In patient	896296022L	1						1	Chills; Pharyngitis; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095822	03/06/1997	FL				F	10/16/1996	pt devel laryngitis & a sore throat 2 days p/vax;pt had recovered as of the date of this report;this is one of four pt from this site to have an adverse exp p/flu vax;									Y	10/12/1996	10/14/1996	2		OTH	PVT	NONE	NONE		~ ()~~~In patient	896296023L	1						1	Laryngitis; Pharyngitis	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095823	03/06/1997	OH	72.0	72		F	10/18/1996	this pt devel a pruritic rash on the trunk & extremities 24-36 hr p/vax;following a skin biopsy MD dx viral rash;pt was treated w/DPH & topical corticosteroid;									U	10/12/1996	10/13/1996	1	skin biopsy-results not provided;	PVT	PVT	Norvasc	unk		~ ()~~~In patient	896297023L	1						1	Infection; Pruritus; Rash	FLU3~PFIZER\WYETH~~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095824	03/06/1997	CA	36.0	36		F	10/18/1996	pt devel a h/a 5 to 6 days p/vax;16OCT96 pt contacted the reporter & stated that pt had been dx w/viral meningitis;pt believed this event to be r/t vax;reporting nurse stated that out of 500 vaccinees, this was only person who reported rxn									Y	10/01/1996	10/06/1996	5	No vaccine was returned for inspection;retention samples were examples and found to be satisfactory;batch records were reviewed and found to be satisfactory;	OTH	PVT	Claritin	unk	multiple sclerosis	~ ()~~~In patient	896297024L	1						1	Headache; Infection; Meningism	FLU3~PFIZER\WYETH~4968192~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095825	03/06/1997	MO				U	10/17/1996	pt devel induration & erythema @ inj site p/vax;									U	10/15/1996	10/17/1996	2		PVT	PVT	unk	unk		~ ()~~~In patient	896298001L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4968181~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095826	03/06/1997	NC				M	10/21/1996	this is 1 of 4 hosp employees to exp hypotension (systolic BP, 75-80) w/nausea, dizziness, shakiness, weakness, & flushing immed p/vax;pt was placed in trendelenburg position & recovered;									Y	10/18/1996	10/18/1996	0		PUB	PVT	unk	NONE		~ ()~~~In patient	896298003L	1						1	Asthenia; Dizziness; Hypotension; Nausea; Tremor; Vasodilatation	FLU3~PFIZER\WYETH~4968190~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095827	03/06/1997	NC				M	10/21/1996	This is 1 of 4 hosp employees to exp hypotension w/nausea, dizziness, shakiness, weakness, & flushing immed p/vax;									Y	10/18/1996	10/18/1996	0		PUB	PVT	unk	NONE		~ ()~~~In patient	896298017L	1						1	Asthenia; Dizziness; Hypotension; Nausea; Tremor; Vasodilatation	FLU3~PFIZER\WYETH~4968190~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095828	03/06/1997	NC				F	10/21/1996	this is 1 of 4 hosp employees to exp hypotension w/nausea, dizziness, shakiness, weakness, & flushing immed p/vax;									Y	10/18/1996	10/18/1996	0		PUB	PVT	unk	NONE		~ ()~~~In patient	896298018L	1						1	Asthenia; Dizziness; Hypotension; Nausea; Tremor; Vasodilatation	FLU3~PFIZER\WYETH~4968190~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095829	03/06/1997	NC				F	10/21/1996	this is 1 of 4 hospital employees to exp hypotension w/nausea, dizziness, shakiness, weakness, & flushing immed p/vax;									Y	10/18/1996	10/18/1996	0		PUB	PVT	unk	NONE		~ ()~~~In patient	896298019L	1						1	Asthenia; Dizziness; Hypotension; Nausea; Tremor; Vasodilatation	FLU3~PFIZER\WYETH~4968190~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095830	03/06/1997	MD				U	10/18/1996	this is 1 of 5 hosp employees, out of 280 vaccines, who devel an inj site rxn 24 to 48hr p/vax;									U	10/14/1996	10/15/1996	1		PUB	PVT	unk	unk		~ ()~~~In patient	896297022L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~4968182~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095831	03/06/1997	MD				U	10/18/1996	this is 1 of 5 hosp employees, out of 280 vaccines, who devel an inj site rxn 24 to 48 hr p/vax;									U	10/14/1996	10/15/1996	1		PUB	PVT	unk	unk		~ ()~~~In patient	896302028L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~4968182~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095832	03/06/1997	MD				U	10/18/1996	this is 1 of 5 hosp employees, out of 280 vaccines, who devel an inj site rxn 24 to 48 hr p/vax;									U	10/14/1996	10/15/1996	1		PUB	PVT	unk	unk		~ ()~~~In patient	896302029L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~4968182~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095833	03/06/1997	MD				U	10/18/1996	this is 1 of 5 hosp employees, out of 280 vaccines, who devel an inj site rxn 24 to 48hr p/vax;									U	10/14/1996	10/15/1996	1		PUB	PVT	unk	unk		~ ()~~~In patient	896302939L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~4968182~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095834	03/06/1997	MD				U	10/18/1996	this is 1 of 5 hosp employees, out of 280 vaccines, who devel an inj site rxn 24 to 48 hr p/vax;									U	10/14/1996	10/15/1996	1		PUB	PVT	unk	unk		~ ()~~~In patient	896302031L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~4968182~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095835	03/06/1997	KS	83.0	83		F	10/22/1996	pt recv vax in lt deltoid;next day pt devel a sharp, constant pain which originates in lt deltoid & radiates to fingers;ROM is limited;pt has been taking Advil & APAP w/o relief;									N	10/03/1996	10/04/1996	1		PUB	OTH	unk	NONE		~ ()~~~In patient	896303043L	1						1	Hypokinesia; Injection site pain; Pain	FLU3~PFIZER\WYETH~4968165~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095836	03/06/1997	MT				F	10/22/1996	pt recv vax & devel a h/a which persisted @ the date of this report despite self-medication w/analgesics;									U	10/17/1996	10/17/1996	0		PUB	OTH	unk	NONE	hx of h/a;	~ ()~~~In patient	896305003L	1						1	Headache	FLU3~PFIZER\WYETH~~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095837	03/06/1997	MA	69.0	69		F	10/22/1996	pt recv vax & devel blood glucose levels greater than 200;the pt also exp chills;no further info was available @ the date of this report;									U	10/14/1996	10/18/1996	4		OTH	OTH	Cozar;Lasix;Insulin 70/30;Catapress patch;Amitriptyline;Toprol XL;	unk	insulin-dependent diabetes mellitus	~ ()~~~In patient	896305007L	1						1	Chills; Hyperglycaemia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095838	03/06/1997	OH				F	10/22/1996	approx 1wk p/vax pt devel vertigo & tinnitus;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896305008L	1						1	Tinnitus; Vertigo	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095839	03/06/1997	MA	41.0	41		F	10/21/1996	pt recv vax & over the next 2 days pt devel muscle weakness & dimpling @ the site of inj;5 days p/vax an area of muscle @ the inj site, measuring 3 long by 1/2 deep, was noted to be wasting & atrophied;				Y					N	10/16/1996	10/18/1996	2		OTH	OTH	unk	unk		~ ()~~~In patient	896305011L	1						1	Injection site atrophy; Injection site hypersensitivity; Injection site pain; Muscle atrophy; Myasthenic syndrome	FLU3~PFIZER\WYETH~4968173~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0095444	03/07/1997	AL	56.0	56		M	02/24/1997	pt recv vax 11OCT96 & 10NOV96 pt devel severe pain in back & was hosp on the same day for 8 days;dx w/transverse myelitis;pt is paralyzed from waist down;					Y	7			N	10/11/1996	11/10/1996	30	NONE	OTH	OTH	Morphine PUMP	NONE	hx of disc fusion (3 surgeries)	~ ()~~~In patient	001015097008800	1						1	Back pain; Condition aggravated; Myelitis; Paralysis	FLU3~PARKE-DAVIS~00966P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0095519	03/07/1997	PA	27.0			F	12/18/1996	pt c/o erythema w/urticaria @ inj site;										10/28/1996	10/29/1996	1		UNK	UNK				~ ()~~~In patient		1						1	Agitation; Injection site hypersensitivity; Urticaria	FLU3~PARKE-DAVIS~00296P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0095521	03/07/1997	NY	84.0	84		M	02/12/1997	pain @ inj site;									Y	11/06/1996	11/06/1996	0		OTH	PUB				~ ()~~~In patient	BAQ004	1						1	Injection site pain	FLU3~CONNAUGHT LABORATORIES~6F71289~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0095512	03/10/1997	PA	74.0	74		F	02/20/1997	5FEB97 inc temp, c/o SOB, BP 190/100 adm to hosp;07FEB97 +influenza upon cult as reported by hosp;dx influenza A & pneumonia;					Y	4			Y	10/22/1996	02/05/1997	106	RVC-+influenza A	OTH	OTH	yes	NONE	s/p ORIF  fx;angina;depression	~ ()~~~In patient		1						1	Drug ineffective; Dyspnoea; Hypertension; Infection; Pneumonia; Pyrexia; Drug ineffective; Dyspnoea; Hypertension; Infection; Pneumonia; Pyrexia	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Hospitalisation	Influenza
0095539	03/10/1997	KY	36.0	36		F	02/24/1997	29OCT96 devel aching, fatigue, malaise & required bed rest through 31OCT;immed p/that devel severe lt hip pain;tx w/ pred temp relief;saw MD on 29JAN96 recv cortisone inj w/immed relief recurrent hip pain;sl tightness;				Y					Y	10/24/1996	10/29/1996	5		PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Arthralgia; Asthenia; Hypokinesia; Malaise; Myalgia	FLU3~CONNAUGHT LABORATORIES~6F71288~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0095552	03/10/1997	NE	36.0	36		F	10/08/1996	pt recv vax 2OCT96 in lt upper arm & since this shot pt lt arm has been getting inc weaker until today was unable to lift child or hardly anything;it is very painful to lift lt arm;										10/02/1996	10/02/1996	0	NONE	PUB	UNK		NONE	sulfa, norgesic forte	NONE~ ()~~~In patient		1						1	Hypokinesia; Myasthenic syndrome; Pain	FLU3~PFIZER\WYETH~4968172~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095553	03/10/1997	NE	33.0	33		F	10/30/1996	h/a last 1hr off & on;sick to stomach, diarrhea 1x/day x 10 days;vomiting x 1 on 1st day;little dizzy in AM then fine;										10/17/1996	10/20/1996	3	NONE	PVT	UNK	NONE	stomach	NONE	NONE~ ()~~~In patient		1						1	Diarrhoea; Dizziness; Headache; Nausea; Vomiting	FLU3~PFIZER\WYETH~4968172~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0095568	03/10/1997	PA	88.0	88		F	02/26/1997	1FEB97 temp 100.2, loose cough, malaise;4FEB97 recv flu vax;given med;				Y					Y	10/22/1996			positive influenza A	OTH	OTH	yes	NONE	duodenal ulcer, degen back disease, DJD, ASCVD	~ ()~~~In patient		1						1	Cough; Drug ineffective; Infection; Malaise; Pyrexia; Cough; Drug ineffective; Infection; Malaise; Pyrexia	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0095569	03/10/1997	PA	85.0	85		F	02/20/1997	3FEB97 inc temp, moist cough;6FEB97 cult positive Influenza A;									Y	10/21/1996	02/03/1997	105	6FEB97 positive cult influenza A;	OTH	OTH	yes	NONE	hypertension, glaucoma	~ ()~~~In patient		1						1	Cough; Drug ineffective; Infection; Pyrexia; Cough; Drug ineffective; Infection; Pyrexia	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095570	03/10/1997	PA	79.0	79		F	02/26/1997	fever 29JAN97 ATB given;coughing 4FEB97 med given;vomiting 18FEB91 med given;									Y	10/23/1996	01/28/1997	97		OTH	OTH	yes	NONE	HTN-s/p CVA	~ ()~~~In patient		1						1	Cough; Pyrexia; Vomiting; Cough; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~00296P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095571	03/10/1997	PA	94.0	94		F		coughing 30JAN97 given entex;fever 4FEB97 given med;pt recv flu vax 11FEB97;									Y	10/23/1996	01/30/1997	99		OTH	OTH	yes	NONE	COPD w/bronchitis-osteoarthritis;	~ ()~~~In patient		1						1	Condition aggravated; Cough; Pyrexia; Cough; Pyrexia	FLU3~PARKE-DAVIS~00296P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095572	03/10/1997	PA	93.0	93		F		fever, cough, inc lethargy-unable feed;given med;									Y	10/23/1996	01/29/1997	98	RUCU 30JAN97 positive influenza;	OTH	OTH	yes	NONE	dementia-HTN	~ ()~~~In patient		1						1	Anorexia; Cough; Drug ineffective; Infection; Pyrexia; Somnolence; Anorexia; Cough; Drug ineffective; Infection; Pyrexia; Somnolence	FLU3~PARKE-DAVIS~00296P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095573	03/10/1997	PA	84.0	84		F		coughing 30JAN97 given med;									Y	10/23/1996	01/30/1997	99		OTH	OTH	yes	NONE	parkinson's disease-CAD	~ ()~~~In patient		1						1	Cough; Cough	FLU3~PARKE-DAVIS~00296P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095574	03/10/1997	PA	82.0	82		M	02/26/1997	4FEB97 moist, non productive cough, afeb;3FEB97 given med x 21 days;			Y	Y					Y	10/28/1996	02/04/1997	99		OTH	OTH	yes	NONE	CHF, CRF, ischemic cardiomyopathy, polymyalgia rheumatica	~ ()~~~In patient		1						1	Cough; Cough	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Life Threatening	Influenza
0095575	03/10/1997	PA	95.0	95		F	02/26/1997	1FEB97 afeb (nasal congestion, loose cough); 3FEB97 given med x 21 days;				Y					Y	10/22/1996	02/01/1997	102		OTH	OTH	yes	NONE	MI, aortic sclerosis, UTI, CHF	~ ()~~~In patient		1						1	Cough; Rhinitis; Cough; Rhinitis	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0095576	03/10/1997	PA	81.0	81		F	02/26/1997	30JAN97 t100, cough & chest congestion;4FEB97 pt given med x 21 days;				Y					Y	10/23/1996	01/30/1997	99		OTH	OTH	yes	NONE	HTN, glaucoma, s/p CVA	~ ()~~~In patient		1						1	Cough; Lung disorder; Pyrexia; Cough; Lung disorder; Pyrexia	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0095577	03/10/1997	PA	0.1	0	.1	F	02/26/1997	30JAN97 t99.8, cough, nasal congestion;4FEB97 med given x 21 days;				Y					Y	10/23/1996	01/30/1997	99		OTH	OTH	yes	NONE	ASHD, cardiovascular disease	~ ()~~~In patient		1						1	Cough; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~00296P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0095578	03/10/1997	PA	92.0	91		F	02/26/1997	1FEB97 t100, productive cough;4FEB97 pt given med x 21 days;				Y					Y	10/23/1996	02/01/1997	101		OTH	OTH	yes	NONE	atrial fib, mitral valve, NIDDM, adjustment disorder	~ ()~~~In patient		1						1	Cough; Pyrexia; Cough; Pyrexia	FLU3~PARKE-DAVIS~00296P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0095579	03/10/1997	PA	94.0	94		F	02/26/1997	1FEB97 started w/loose cough afeb;3FEB97 given med x 21 days;				Y					Y	10/21/1996	02/01/1997	103		OTH	OTH	yes	NONE	chronic atrial fib, HTN, CRF, COPD	~ ()~~~In patient		1						1	Cough; Cough	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0095580	03/10/1997	PA	81.0	81		F	02/26/1997	1FEB97 t98.2 c/o post nasal drip, moist non-productive cough;inc temp 3FEB97, robitussin ordered 1FEB97; given other med 3FEB97 & again 18FEB97 x 7 days;no cult ordered;										10/23/1996	02/01/1997	101	NONE ordered	OTH	OTH	yes	NONE	HTN, hypothyroid, depression, dementia, arthritis;	~ ()~~~In patient		1						1	Cough; Pyrexia; Rhinitis; Cough; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095581	03/10/1997	PA	81.0	80		F	02/26/1997	31JAN97 cold sx-runny nose, t97.7;1FEB97 t99, pt given med;cult ordered 4FEB97; 12FEB97 Robitussin;28FEB97 med given x 7 days;									Y	10/22/1996	01/31/1997	101	positive RVC positive influenza A;	OTH	OTH	yes	NONE	bowel obstruction s/p bilat mastectomies, arthritis;	~ ()~~~In patient		1						1	Cough decreased; Drug ineffective; Infection; Pyrexia; Rhinitis; Drug ineffective; Infection; Pharyngitis; Rhinitis	FLU3~PARKE-DAVIS~00296P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095582	03/10/1997	PA	72.0	72		F	02/26/1997	2FEB97 t99.4, moist cough, SOB-med given 3FEB97 x 2wk;18FEB97 proventil given, robitussin/ceclor & flumadine x 7 days;no cult ordered;									Y	01/23/1997	02/02/1997	10	NONE ordered;pulse ox	OTH	OTH	yes		dysphocla, wt loss, MS, reflux esophagitus	~ ()~~~In patient		1						1	Cough; Dyspnoea; Pyrexia	FLU3~PARKE-DAVIS~00296P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0095583	03/10/1997	PA	72.0	72		F	02/26/1997	29JAN97 c/o nasal congestion, 30JAN97 99.9 actifed/robitussin x 1wk; Flumadine 3FEB97 x 2wk;flumadine reordered 18FEB97 x 7 days;									Y	10/21/1996	01/29/1997	100	NONE-no throat cult	UNK	UNK		cellulitis rt leg (Keflex series)	bilat cellulitis, NIDDM, obesity, HTN, anemia	~ ()~~~In patient		1						1	Pyrexia; Rhinitis; Rhinitis	FLU3~PARKE-DAVIS~00296P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095584	03/10/1997	PA	91.0	91		F	02/26/1997	3FEB97 t101.7, chest congestion, wheezing, non productive cough-robitussin PM/Zithromax x 5 days;4FEB97 t102.1;re-vax on 7FEB97;									Y	10/22/1996	02/03/1997	104	positive RVC influenza A;	OTH	OTH	yes	NONE	dementia, ostearthritis	~ ()~~~In patient		1						1	Asthma; Cough; Drug ineffective; Infection; Lung disorder; Pyrexia; Asthma; Cough; Drug ineffective; Infection; Lung disorder; Pyrexia	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095585	03/10/1997	PA	78.0	77		M	02/26/1997	10FEB97 c/o sore throat, runny nose, 10FEB97 t99.8;11FEB97 cough, nasal congestion, cough;MD to examine throat cult ordered positive influenza A on 11FEB97;									Y	10/22/1996	02/10/1997	111	positive influenza A (throat cult) 11FEB97;	OTH	OTH	yes	NONE	s/p CVA x 2; chronic atrial fibrillation	~ ()~~~In patient		1						1	Cough; Drug ineffective; Infection; Pharyngitis; Pyrexia; Rhinitis; Cough; Drug ineffective; Infection; Pharyngitis; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~00296P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095586	03/10/1997	PA	72.0	72		M	02/26/1997	11FEB97 occasional loose cough;inc temp 99.9, lethargic;12FEB97 t100.4, cough 13FEB97 t102.5;med given 3FEB97 until 12FEB97;12FEB97 positive influenza A type a isolated;									Y	10/22/1996	02/11/1997	112	12FEB97 positive influenza A;	OTH	OTH	yes	NONE	parkinson's disease, dementia, diabetes;	~ ()~~~In patient		1						1	Cough; Drug ineffective; Infection; Pyrexia; Somnolence; Cough; Drug ineffective; Infection; Pyrexia; Somnolence	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095587	03/10/1997	PA	92.0	91		F	02/26/1997	29JAN97 t100.8 productive cough, nasal congestion;med given x 21 days 4FEB97;				Y					Y	10/23/1996	01/29/1997	98		OTH	OTH	yes	NONE	ASHD, degenarative disc disease, osteoporosis, DJD	~ ()~~~In patient		1						1	Cough; Pyrexia; Rhinitis; Cough decreased; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~00296P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0095588	03/10/1997	PA	90.0	90		M	02/26/1997	26JAN97 temp 100.7, productive cough;med x 21 days 4FEB97;				Y					Y	10/23/1996	01/26/1997	95		OTH	OTH	yes	NONE	COPD, ASHD, DJD, IBS	~ ()~~~In patient		1						1	Cough; Pyrexia; Cough; Pyrexia	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0095589	03/10/1997	PA	85.0	84		F	02/26/1997	29JAN97 productive cough, afeb;RVC positive influenza A 30JAN97; 4FEB97 med given x 21 days;				Y					Y	10/17/1996	01/29/1997	104	RVC positive influenza A;	OTH	OTH	yes	NONE	chronic asthma, asthenic personality, cerebrovascular, ischemic disease, anxiety	~ ()~~~In patient		1						1	Cough; Drug ineffective; Infection; Cough; Drug ineffective; Infection	FLU3~PARKE-DAVIS~00296P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0095590	03/10/1997	PA	94.0	94		F	02/24/1997	3FEB97 inc temp, cough;4FEB97 RCV obtained;6FEB97 cult positive influenza A;									Y	10/21/1996	02/03/1997	105	RVC positive influenza A;	OTH	OTH	yes	NONE	alzheimer's dementia, pressure ulcer rt toe;	~ ()~~~In patient		1						1	Cough; Drug ineffective; Infection; Pyrexia; Cough; Drug ineffective; Infection; Pyrexia	FLU3~PARKE-DAVIS~00296D~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095591	03/10/1997	PA	82.0	81		F	02/24/1997	2FEB97 inc temp, cough, h/a;3FEB97 RVC obtained;7FEB97 cult positive influenza A;									Y	10/21/1996	02/02/1997	104	RVC positive influenza A;	OTH	OTH	yes	NONE	non communicating hydrocephalous, sinus tach, osteoprosis;	~ ()~~~In patient		1						1	Cough; Drug ineffective; Headache; Infection; Pyrexia; Cough; Drug ineffective; Infection; Pyrexia	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095593	03/10/1997	PA	89.0	89		F	02/26/1997	3FEB97 t100.6 exp wheeze, rales in bilat lung fields;4FEB97 RVC positive influenza A; med given x 21 days 3FEB97;				Y					Y	10/21/1996			RVC positive influenza A;	OTH	OTH	yes	NONE	COPD, CAD, CHF, ASWD	~ ()~~~In patient		1						1	Asthma; Drug ineffective; Infection; Lung disorder; Pyrexia; Asthma; Drug ineffective; Infection; Lung disorder; Pyrexia	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0095594	03/10/1997	PA	81.0	81		F	02/26/1997	3FEB97 temp 100.2, malaise, loose cough, nasal congestion;4FEB97 RVC positive influenza A;3FEB97 med given x 21 days;				Y					Y	10/21/1996			RVC positive influenza A;	OTH	OTH	yes	NONE	NIDDM, cerbrovascular disease, urinary retention, dementia;	~ ()~~~In patient		1						1	Cough; Drug ineffective; Infection; Malaise; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~00296P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0095595	03/10/1997	PA	85.0	85		M	02/26/1997	4FEB97 t100.4 & confusion, malaise;4FEB97 RVC positive influenza A;3FEB97 med given x 21 days;				Y					Y	10/21/1996			RVC positive influenza A;	OTH	OTH	yes	NONE	HTN, dementia, aortic sclerosis, BPH	~ ()~~~In patient		1						1	Confusional state; Drug ineffective; Infection; Malaise; Pyrexia	FLU3~PARKE-DAVIS~00296~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0095597	03/10/1997	MI	78.0	78		F	01/15/1997	pt devel weakness (total body) 9OCT96 AM;pain localized to upper rt arm (?deltoid muscle);felt like tightness-nerve pain that radiated to back (rt scapula area over the next few days);pain went up into face;saw MD-sinus infect/teeth p								Y	U	10/08/1996	10/09/1996	1		PUB	PUB	NONE weekly allergy inj	NONE	allergies to tree, grass & molds;no food allergies;	pt son devel eczema as teenger p/flu vax;~ ()~~~In patient	MI97009	1						1	Asthenia; Back pain; Hypokinesia; Infection; Injection site pain; Neuralgia; Pain; Rhinitis	FLU3~PFIZER\WYETH~4968172~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0095613	03/10/1997	MA	76.0	75		F	02/27/1997	pt reports became ill 4NOV96 w/body aches, neck, shoulder pain, unable to walk unaided, double vision, watery, puffy eyes;				Y					Y	10/30/1996	11/04/1996	5	unk-not treated @ this clinic	PUB	PUB	unk	NONE	NONE	NONE~ ()~~~In patient		1						1	Arthralgia; Diplopia; Face oedema; Hypokinesia; Lacrimal disorder; Malaise; Myalgia; Neck pain; Asthenia; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71275~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71275~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0095605	03/12/1997	NJ	29.0	29		M	02/19/1997	GBS preceded by stomach flu late NOV & cold;late Dec-JAN GBS treated w/steroids & plasmapheresis;					Y	21			U	10/09/1996	11/26/1996	48		OTH	OTH		NONE	transverse myelitis 18/90	~ ()~~~In patient		1						1	Gastrointestinal disorder; Guillain-Barre syndrome; Influenza; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0095638	03/13/1997	MI	7.0	7		M	02/20/1997	pt w/hx of sz disorder  in OCT/96 & NOV96;approx 24 p/vax NOV96 pt devel a fever ax temp 104-105 & sz;taken to ER in post-ictal state, given IV fluids;observed overnoc & sent home;devel fever & sz 3-4wk;				Y	Y	1			Y	11/08/1996	11/08/1996	0		PVT	OTH	Tegretol	NONE	pre-term infant born @ 27wk gestation;bronchopulmonary dysplasia;sz disorder dx JUN95;was sx-free for approx 6mo prior to NOV96;	~ ()~~~In patient	897055002L	1						1	Condition aggravated; Convulsion; Dehydration; Grand mal convulsion; Pyrexia; Stupor	FLU3~PFIZER\WYETH~4968184~4~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0095639	03/13/1997	GA	72.0	72		F	03/06/1997	pt recv vax SEP96 & devel flu sx, loss of taste x/events to the present, loss of smell & sinus drainage in DEC96 & cont w/these events to present;pt states these events have affected daily living;pt to MD & given ATB;				Y				Y	N	09/01/1996	12/01/1996	91		PVT	PVT	unk	NONE	pt medical history is remarkable for phlebitis, hysterectomy & back trouble;	~ ()~~~In patient	0010150970090	1						1	Ageusia; Infection; Influenza; Parosmia; Rhinitis; Sinusitis	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Disabling	Influenza
0096260	03/14/1997	CA	68.0	68		F	02/03/1997	started w/h/a then went into the lungs w/coughing & pain in chest;no fever noted;MD stated that it was influenza type A;prescribed an inhalant & ATB;devel pneumonia;no hosp necessary;lasted about 2.5 wk;									Y	10/22/1996	01/14/1997	84	CXR	PUB	PUB	Premarin/Batagar	NONE	NONE	~ ()~~~In patient	CA970012	1						1	Chest pain; Cough; Drug ineffective; Headache; Infection; Lung disorder; Pneumonia	FLU3~CONNAUGHT LABORATORIES~6F71212~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0096274	03/14/1997	NY	40.0			F		swelling/itching, & redness of arms/legs;										11/17/1996	11/23/1996	6		UNK	UNK	Lorazepan;Benztrapinc;Halopendail;ferrous gluconate;		allergic-PCN, fish;	~ ()~~~In patient		1						1	Oedema peripheral; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4968182~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0096381	03/19/1997	CA	57.0	57		F	02/05/1997	lympadenitis & cellulitis-rt axilla tx w/ATB;seen by MD;				Y					Y	09/19/1996	09/26/1996	7	WBC inc 13.7, neg blood cult;	OTH	PVT	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Cellulitis; Lymphadenopathy	FLU3~PFIZER\WYETH~4968162~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0096383	03/19/1997	MS	46.0	46		F	02/28/1997	935AM pt presented to ER c/o diff breathing, tingling around lips, skin warm & dry;bilat wheezing on expirations;coughing forcefully;10AM breathing better lungs CTA all fiedls;1030AM breathing clearly still;tx w/02, epi, Nebulizer;				Y					Y	10/17/1996	10/17/1996	0	BP 118/54;P72;R36;t98.5;P84;R20;T98.5;	PUB	OTH	Ventolin;Vanceril puff;	hx of asthma	allergies: codeine, fragrances & others;no other drugs;	could not tolerate allergy shots;no brothers or sisters~ ()~~~In patient		1						1	Asthma; Condition aggravated; Cough; Dyspnoea; Hyperventilation; Hypoxia; Paraesthesia; Vasodilatation	FLU3~PFIZER\WYETH~4968166~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0096395	03/19/1997	TX	50.0	50		F	03/17/1997	soreness @ inj site that has, not gone away;cont to be sore & spreading to entire arm, chest, & legs;all over body soreness;occasional fever, flu like sx;hard time walking now;									U	10/11/1996	10/11/1996	0		OTH	OTH	Not known	not known	not known	~ ()~~~In patient		1						1	Chest pain; Hypokinesia; Injection site pain; Myalgia; Pain	FLU3~PFIZER\WYETH~4968165~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0096330	03/20/1997	OH	28.0	28		M	12/30/1996	weakness;ataxia;poss GBS;				Y	Y				Y	10/28/1996	11/18/1996	21		PUB	PUB	Cogentin;DPH	schizo, paranoid chronic	schizo, paranoid chronic	NA~ ()~~~In patient	OH97028	1						1	Asthenia; Coordination abnormal; Guillain-Barre syndrome; Asthenia; Coordination abnormal; Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~6F71217~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6771217~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0095512	03/24/1997	PA	74.0	74		F	02/20/1997	pt recv vax 22OCT96 & 5FEB97 exp inc temp & SOB;BP was 190/100;hosp for 4 days;throat cult was positive for influenza A;dx pneumonia & influenza A;					Y	4			Y	10/22/1996	02/05/1997	106	RVC: positive for influenza A;	OTH	OTH	unk	NONE	status/post ORIF fracture;hx angina, depression;	~ ()~~~In patient	0010150970091	1						2	Drug ineffective; Dyspnoea; Hypertension; Infection; Pneumonia; Pyrexia; Drug ineffective; Dyspnoea; Hypertension; Infection; Pneumonia; Pyrexia	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Hospitalisation	Influenza
0096413	03/24/1997	WI	41.0			F	01/10/1997	pt recv vax & devel local erythema, pruritis, & hives;eyes became puffy & c/o tongue felt swelled;stated that had a feeling of fullness in throat;had associated hoarseness;adm to ICU for observation;				Y	Y					10/31/1996	10/31/1996	0		UNK	UNK			hx of COPD and asthma	~ ()~~~In patient		1						1	Dysphonia; Face oedema; Injection site hypersensitivity; Laryngospasm; Pruritus; Tongue oedema; Urticaria	FLU3~PARKE-DAVIS~00476P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0096443	03/24/1997	OK	11.0	11		F	02/12/1997	11MAR97 mom states pt devel fever, dizziness & swelling @ inj site of vax;PA states pt will not give order for any further hep B vax d/t possibility of allergic rxn worsening;									Y	10/22/1996	10/22/1996	0	NA	PUB	PUB	NONE	NONE	nONE	NONE~ ()~~~In patient	OK9715	1						1	Dizziness; Hypersensitivity; Injection site oedema; Pyrexia	FLU3~PARKE-DAVIS~E3066GB~2~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~MERCK & CO. INC.~0890B~1~~RA~HEP B (RECOMBIVAX HB)~1	USA		Influenza
0096431	03/25/1997	RI	62.0			F	12/13/1996	jaw tightness, hearing loss, visual changes;					Y					11/07/1996	11/07/1996	0		UNK	UNK	Terfenadine, triamterene/HCTZ (dyazide);			~ ()~~~In patient		1						1	Deafness; Hypertonia; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0096512	03/27/1997	NY	74.0	74		M		pt felt sick & weak p/vax;worse next day, fainted, fell, mouth bleeding;when conscious was afraid to get up, went to bed, had urge to throw up but did not;sweated profusely, lost control of bowels;became sick went to MD-felt sz not r/t vax;				Y					Y	10/09/1996	10/10/1996	1		UNK	UNK			anxiety	~ ()~~~In patient		1						1	Asthenia; Convulsion; Faecal incontinence; Hyperhidrosis; Injury; Malaise; Nausea; Syncope; Anorexia; Asthenia; Diarrhoea; Hyperhidrosis; Malaise; Myasthenic syndrome; Syncope	FLU3~PFIZER\WYETH~~2~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968173~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0095613	03/28/1997	MA	76.0	75		F	03/24/1997	fatigue, weakness, malaise, intermittent low grade fever;onset 5NOV96 cont to present;									N	10/30/1996	11/05/1996	6	general medical & neuro eval @ hosp-no objective abnorm;	PUB	PUB	anti-hypertensives		NONE	~ ()~~~In patient		1						2	Arthralgia; Diplopia; Face oedema; Hypokinesia; Lacrimal disorder; Malaise; Myalgia; Neck pain; Asthenia; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71275~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6F71275~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0096330	03/31/1997	OH	28.0	28		M	03/14/1997	weakness;ataxia;possible GBS;					Y					10/01/1996	11/18/1996	48		UNK	UNK	Cogentin;DPH;Zyprexa;			~ ()~~~In patient		1						2	Asthenia; Coordination abnormal; Guillain-Barre syndrome; Asthenia; Coordination abnormal; Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~6F71217~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~6771217~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0096583	03/31/1997	OH	74.0	74		M	03/19/1997	pt had diff raising lt arm since day p/inj;c/o pain localized @ inj site & diff w/showering & dressing;pt feels sx are worse now;tx w/Myoflex;did not consult FMD;									N	10/23/1996	10/24/1996	1		OTH	PUB	Procardia XL;Thurems;Metroprolol		stabbed lt shoulder 1940, allergies ASA, CVD	NONE~ ()~~~In patient		1						1	Hypokinesia; Injection site pain	FLU3~CONNAUGHT LABORATORIES~6F71308~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~432690~UNK~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0096615	03/31/1997	NY	42.0	42		M	01/09/1997	pt given flu vax @ 12noon;@ 430PM pt exp dull achy pain lt shoulder w/softball sized lump @ inj site;c/o chest pressure & mild itchiness all over, worsened over 6hr;went to ER @ 11PM;				Y					Y	10/10/1996	10/10/1996	0	NONE	PUB	UNK	Seldane PRN allergies		MD dx allergies-peaches, ragweed, straw/hay, dust, molds	~ ()~~~In patient	NY97001	1						1	Chest pain; Injection site mass; Myalgia; Pruritus	FLU3~PFIZER\WYETH~4968185~7+~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0096675	04/02/1997	TX	28.0	28		F	03/18/1997	pt exp SOB, chest pain, & rapid heart beat;in hosp pt devel flu sx;dx idiosyncratic rxn to med;dx supraventricular tachycardia, esophageal problems-gastric erosions;temp inc;vent tachycardia;virus may have attacked area of heart;				Y	Y	13			Y	10/09/1996	10/18/1996	9	OCT96 routine blood work, 24hr urine, echocardiogram, holter monitor, lung scan, EKG, gallbladder ultra sound: all WNL3JAN97 chest x-ray; no results reported;EKG supravenricular tachycardia;electrophysiology study no specific results-strep	OTH	OTH	Flexeril, Relafen, Trazodone, Tenormin, Prevacid, Calan SR	NONE	hx of shoulder injury w/subsequent cortisone inject & surgery;NKA;	~ ()~~~In patient	001015097011900	1						1	Cardiovascular disorder; Chest pain; Dyspnoea; Gastric ulcer; Pyrexia; Supraventricular tachycardia; Tachycardia; Ventricular tachycardia	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0092835	04/07/1997	MO	35.0	35		F	03/29/1997	lightheadedness, rise in BP, muscle weakness, muscle fasciculations, extreme fatigue, shakiness of limbs, uncoordination, loss of balance;sx evolved over a course of approx 2wk;still exp these sx 5mo later;tx by 4 MD;				Y	Y	3		Y	N	10/28/1996	10/28/1996	0	MRI, CT scan, 2 LP, 2 CXR, EKG, stress test, EEG, endocardiogram, Tensalon test for muscular dystrophy, numerous blood test;	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						2	Coordination abnormal; Dizziness; Hypertension; Hypokinesia; Muscle twitching; Myasthenic syndrome; Tremor; Asthenia; Coordination abnormal; Dizziness; Hypertension; Muscle twitching; Myasthenic syndrome; Tremor	FLU3~CONNAUGHT LABORATORIES~6F71239~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2|TTOX~CONNAUGHT LABORATORIES~5L71095~UNK~~~TETANUS TOXOID (NO BRAND NAME)~2|FLU3~CONNAUGHT LABORATORIES~6F71239~1~~~INFLUENZA (SEASONAL) (FLUZONE)~3|TD~CONNAUGHT LABORATORIES~5L71095~UNK~~~TD ADSORBED (NO BRAND NAME)~3	USA	Hospitalisation,Disabling	Influenza
0096706	04/07/1997	UT	32.0	32		F	04/01/1997	dx w/GBS;complete paralysis of legs;severely weakened upper body, torso, arms, hands;no ventilator needed;tx w/Immunoglobulin therapy (5 days);physical therapy (2mo) & pain killers for extreme back pain;regained nl abilities p/ 2.5 mo			Y	Y	Y	13			Y	10/21/1996	12/13/1996	53	EMG/nerve conduction study done on 3JAN97;	PUB	PUB	prenatal vitamins	NONE	6wk pregnant @ onset of illness;recent miscarriage 1 D&C operation about 2wk prior to vax;	NONE~ ()~~~In patient		1						1	Back pain; Guillain-Barre syndrome; Myasthenic syndrome; Paralysis	FLU3~PARKE-DAVIS~4968198~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation	Influenza
0096886	04/11/1997	OH	3.0	3		M	03/25/1997	pt has had chronic illness;pt being eval for poss immune deficiency;parents are questioning if immun in particular the MMR have contributed to the poss autoimmune problems;										09/30/1996				PVT	PVT		NONE		~ ()~~~In patient		1						1	Immune system disorder	FLU3~CONNAUGHT LABORATORIES~6771227~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0096891	04/14/1997	PA	48.0	48		M		exp aches, pains & myalgias;devel paresthesia;to MD told had viral illness given ATB;next day adm to hosp w/GBS;CT scan revealed poss infarction or small arteriovenous malformation;walking w/canes;unsteady gait-balance off; BP 160/110;				Y	Y	35			N	11/07/1996	11/25/1996	18	CXR, central venous line, CT of head represent a small AV malformation or perhaps a recent infarct;spinal fluid colorless, no red cells, no white cells;glucose ws 81 & protein was 108;gulcose 119;alk phos 59;cholesterol 241;LDH 135;MRI	PUB	OTH	pt recv tetanus vax 9NOV97;Capoten;Amoxicillin;rhinocort nasal spray;	NONE	NKA;significant for HTN, PH of nephritis in 1964;hernia repair & tonsillectomy;	~ ()~~~In patient		1						1	Asthenia; Coordination abnormal; Gait disturbance; Guillain-Barre syndrome; Hypertension; Hypokinesia; Laboratory test abnormal; Myasthenic syndrome; Paraesthesia	FLU3~PFIZER\WYETH~4968152~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0096896	04/15/1997	OH	61.0			M	01/20/1997	pt recv vax 9DEC96 & 3 days later to ER w/GBS in the lower extremities which progressed to resp musculature;hosp is presumed, although not documented;					Y		Y		U	12/09/1996	12/23/1996	14		PVT	OTH	Allopurinol;Cipro;Fat Emulsion;Lasix;Lisinopril;Mefoxitin:midazolam;Morphine PCa;Mucomist aerosol;Nitroglycerin;Pepcid;Potassium chloride	unk	COPD, anemia, surgery for colon DEC96;	~ ()~~~In patient	897093026L	1						1	Guillain-Barre syndrome; Respiratory disorder	FLU3~PFIZER\WYETH~4968154~UNK~A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~~~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0096982	04/15/1997	UT	6.0	6		M	03/27/1997	acquired chicken pox 20MAR97;no fever some itching;drowsy #100 pox as of 27MAR97;starting to cry over @ this time;mom states totally covered w/pox;confirmed chicken pox by MD;									Y	10/25/1995	03/20/1997	512		PVT	PVT	NONE	NONE	allergic to PCN-asthma, eczema;	~ ()~~~In patient		1						1	Drug ineffective; Infection; Pruritus; Somnolence	FLU3~PFIZER\WYETH~4958111~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|VARCEL~MERCK & CO. INC.~0427B~1~SC L~~VARICELLA (VARIVAX)~1	USA		Influenza
0096948	04/16/1997	TX	77.0			M	11/18/1996	pt recv vax and shortly p/vax died;MD does not feel that the shot contributed to death;pt recv flu vax in past w/no adverse effects;COD MI;	Y	10/03/1996							N	10/02/1996	10/03/1996	1		PVT	UNK	Procardia XL 30mg		HTN, coronary artery disease	~ ()~~~In patient		1						1	Myocardial infarction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0096949	04/16/1997	TX	78.0			M		pt recv vax & shortly p/vax pt died;MD does not feel shot contributed to death;pt recv flu vax prev w/no adverse effects;COD Myocardial rupture (immed) complete heart block (4 days) MI (5 days);	Y	11/05/1996							N	10/28/1996	10/28/1996	0		PVT	UNK	Zestril, Tenormin, Trazodone;mult vit, calcium, vit C & E, metamucil;		HTN, CAD, chronic renal insufficiency, depression;	~ ()~~~In patient		1						1	Atrioventricular block complete; Myocardial infarction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0059533	04/18/1997	NJ	67.0			M	02/06/1997	Bells Palsy as reported by daughter;states father always gets a cold p/flu shot but now has this;				Y					N					PVT	OTH			hypertension, NKA;		CO6366	1						2	Facial palsy	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0078087	04/18/1997	OK	41.0	41		F	02/05/1997	h/a w/in 1-2hr;had hard shaking chill, stomach cramps (severe), t105, diarrhea, trouble breathing;did not siik med care @ time;only reported on 11OCT95 to med dept;to see pvt MD;weak;MD thought an intestinal virus;rxn not r/t vax;				Y					Y	10/06/1995	10/06/1995	0		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	CO6182	1						2	Abdominal pain; Asthenia; Chills; Diarrhoea; Dyspnoea; Headache; Infection; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61093~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0078116	04/18/1997	IL	41.0	40		F	02/05/1997	immed w/in 30-45seconds, devel urticarial rash on rt upper extremity & felt gen itching all over;DPH, solucortif;rash started to disappear w/in 10-15min;no resp wheezing;				Y					Y	10/04/1995	10/04/1995	0		PUB	OTH			discoid lupus w/pulmonary involvement; prone to rash rxn;	~ ()~~~In patient	CO6161	1						2	Pruritus; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~5F61119~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0078219	04/18/1997	MO	59.0	59		F	02/05/1997	palpable, perifollicular rash on arms, legs & chest, photophobia, achy, low grade fever & sore mouth;worse 4-5 dasy p/vax;				Y					U	10/02/1995	10/04/1995	2		PVT	UNK	Premerin, Provera		drug allergies, but has taken nothing new;	~ ()~~~In patient	CO6173	1						2	Myalgia; Pain; Photophobia; Pyrexia; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~5F61082~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0078259	04/18/1997	IA	38.0	38		F	02/05/1997	body aches, queasy stomach w/cramps & throat felt on fire 2-4hr p/vax;									U	10/17/1995	10/17/1995	0		OTH	OTH			allergy to PCN	~ ()~~~In patient	CO6213	1						2	Abdominal pain; Dyspepsia; Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~5F61117~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0078379	04/18/1997	PA	65.0	65		F	02/05/1997	7cm area of erythema, swollen & warm to touch;local rxn;									Y	10/17/1995	10/17/1995	0		OTH	OTH	Premarin, Zantac	NONE	gastric reflux	~ ()~~~In patient	CO6219	1						2	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61117~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0078402	04/18/1997	MO	31.0	31		M	02/05/1997	watery, glassy eyes, h/a, ataxia (dizziness) & myalgia 12hr p/vax;no weakness, nausea or fever;denies alcohol use, drugs or allergies;feeling only tired as of 25OCT95;other sx resolved;				Y					Y	10/24/1995	10/24/1995	0		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	CO6234	1						2	Asthenia; Coordination abnormal; Dizziness; Headache; Lacrimal disorder; Myalgia; Stupor	FLU3~CONNAUGHT LABORATORIES~5F61115~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0078614	04/18/1997	CO	64.0	64		F	02/05/1997	really agitated, wound-up, wired, aggressive, combative w/in 20min of vax;some itching on lower extremities, no h/a, fever or local rxn;tx w/valium;usually very laid back person;has numerous med conditions;does not like to take pills;				Y					Y	10/18/1995	10/18/1995	0		PVT	PVT	Lanoxin, Acupril, Cardizam Cd, lasix;OTC-sudafed, glynase		HTN, poycythemia (frequent phlemotomies), new diabetic, CHF, smoker, bladder problems;	~ ()~~~In patient	CO6240	1						2	Agitation; Personality disorder; Pruritus	FLU3~CONNAUGHT LABORATORIES~5F61096~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0078620	04/18/1997	NY	44.0	43		F	02/05/1997	immed local rxn while withdrawing needle;whole arm started to swell;hx of artrial fibilation became anxious & BP increased;tx w/ice by 10AM;swelling resolving;had vax in past w/o incident;									Y	10/27/1995	10/27/1995	0		OTH	OTH	Norpace, Kerlon	NONE	PST hx atrial fibrilation	~ ()~~~In patient	CO6237	1						2	Agitation; Hypertension; Injection site reaction; Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~5F61133~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0078636	04/18/1997	CO	54.0	54		F	02/06/1997	burning ears, tingling tongue, swollen eyes 30min p/vax;4hr p/devel cough;tx w/antihistamines;				Y					Y	10/07/1995	10/07/1995	0		OTH	OTH	NONE	NONE	allergic to demerol, chemicals, foods, pollns	~ ()~~~In patient	CO6286	1						2	Cough; Ear pain; Face oedema; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0078637	04/18/1997	MD	2.0	2	.1	F	02/06/1997	devel tejmp 103.7 on 11OCT95 on 12OCT arm swollen, red & sore;20OCT95 seen by MD who debridden arm;placed on wet-dry & ATB; debrided arm & still being treated;				Y					U	10/09/1995	10/12/1995	3		OTH	OTH	NONE	NONE	arthritis	~ ()~~~In patient	CO6284	1						3	Myalgia; Oedema peripheral; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Emergency room visit	Influenza
0078638	04/18/1997	TN	66.0	66		F	02/06/1997	skin became flushed, warm & dry, dizziness, BP 160/80, resp became labored 24min & inc to 30min & fainted;epi given;BP 180/110, P60, R36 shallow;2nd dose of epi given, irratic breathing;transferred to hosp via amb;				Y					U	09/25/1995	09/25/1995	0		OTH	MIL	Synthroid, Premarin	NONE	NONE	~ ()~~~In patient	CO6283	1						2	Dizziness; Dyspnoea; Hypertension; Hyperventilation; Syncope; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61166~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0078639	04/18/1997	WA	33.0	32		F	02/06/1997	diarrhea, h/a, rash & tightness of chest;tx w/DPH;				Y					Y	09/25/1995	09/25/1995	0		OTH	OTH	NONE	NONE	allergic to parrots	~ ()~~~In patient	CO6348	1						3	Chest pain; Diarrhoea; Headache; Rash; Chest pain; Diarrhoea; Headache; Rash	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~3|FLU3~CONNAUGHT LABORATORIES~5F61166~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~4|TD~CONNAUGHT LABORATORIES~5H71142~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~4	USA	Emergency room visit	Influenza
0078639	04/18/1997	WA	33.0	32		F	02/06/1997	rash, chest tightness, diarrhea & h/a;				Y					Y	09/25/1995	09/26/1995	1		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	CO6282	1						4	Chest pain; Diarrhoea; Headache; Rash; Chest pain; Diarrhoea; Headache; Rash	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~3|FLU3~CONNAUGHT LABORATORIES~5F61166~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~4|TD~CONNAUGHT LABORATORIES~5H71142~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~4	USA	Emergency room visit	Influenza
0078645	04/18/1997	WA	23.0	23		F	02/06/1997	immed dizziness, hyperventilating, chest tightness, diff breathing, anxiety;given epi;refused further tx;lt ambulatory;									Y	10/11/1995	10/11/1995	0		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	CO6285	1						2	Agitation; Chest pain; Dizziness; Dyspnoea; Hyperventilation	FLU3~CONNAUGHT LABORATORIES~5F61144~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0078646	04/18/1997	TX	43.0	43		F	02/06/1997	paresthesia in deltoid area & shoulder & back area;feels like pins & needles;									U	10/15/1995	10/16/1995	1		OTH	OTH	NONE	NONE	asthma, cluster h/a;	~ ()~~~In patient	CO6281	1						2	Paraesthesia	FLU3~CONNAUGHT LABORATORIES~5F61166~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0078647	04/18/1997	FL	59.0	59		F	02/06/1997	itchy rash both arms, chest, neck & stomach w/in 24hr of vax;no swelling;tx w/DPH;									U	10/19/1995	10/20/1995	1		OTH	OTH	Premarin	NONE	NONE	~ ()~~~In patient	CO6279	1						2	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~5F61135~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0078648	04/18/1997	SC	44.0	44		F	02/06/1997	Itchy all over, warm all over; took DPH;									U	10/11/1995	10/11/1995	0		OTH	OTH	Dilantin, Clonidine, amytriptilin		sz, rt sided brain damage;	~ ()~~~In patient	CO6278	1						2	Pruritus; Vasodilatation; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61143~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1076B~UNK~IM~LA~PNEUMO (PNEUMOVAX)~2|FLU3~CONNAUGHT LABORATORIES~5F61143~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~4|PPV~MERCK & CO. INC.~1076B~UNK~IM~LA~PNEUMO (PNEUMOVAX)~4	USA		Influenza
0078648	04/18/1997	SC	44.0	44		F	02/05/1997	itching & warm all over;took DPH;									U	10/11/1995	10/11/1995	0		OTH	OTH	Dilatin, Claridin, amytriptaline;		sz-rt side brain damage;	~ ()~~~In patient	CO6226	1						4	Pruritus; Vasodilatation; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61143~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1076B~UNK~IM~LA~PNEUMO (PNEUMOVAX)~2|FLU3~CONNAUGHT LABORATORIES~5F61143~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~4|PPV~MERCK & CO. INC.~1076B~UNK~IM~LA~PNEUMO (PNEUMOVAX)~4	USA		Influenza
0078649	04/18/1997	OK	61.0	61		F	02/06/1997	bruised rt arm & devel welts on back & neck all on rt side;									U	10/17/1995	10/20/1995	3		OTH	OTH	Zantac, Thyroid, Premarin, zocor	NONE	elevated cholesterol, thyroid problem	2 prior flu shots w/o problems;~ ()~~~In patient	CO6276	1						3	Ecchymosis; Urticaria	FLU3~CONNAUGHT LABORATORIES~5F61144~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~1076B~1~IM~LA~PNEUMO (PNEUMOVAX)~3	USA		Influenza
0078650	04/18/1997	MI	29.0	29		F	02/06/1997	clammy, cool skin & blurred vision;BP 132/72, P92;given epi;BP 128/72, P82;									Y	09/25/1995	09/25/1995	0		OTH	OTH				~ ()~~~In patient	CO6275	1						2	Amblyopia; Hyperhidrosis; Tachycardia	FLU3~CONNAUGHT LABORATORIES~5F61144~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0078660	04/18/1997	NJ	67.0	67		F	02/05/1997	rash appeared on both arms from shoulder to wrist;									U	10/20/1995	10/23/1995	3		PUB	PUB	unk	NONE	NONE	~ ()~~~In patient	CO6238	1						2	Rash	FLU3~CONNAUGHT LABORATORIES~5F61023~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0078713	04/18/1997	OH	54.0	54		F	02/05/1997	itching of lips & nose w/in 20min of vax;devel nausea & vomiting for 15min cont, progressed to face flushed & then gen non-raised rash;given DPH & observed for 1hr & released w/sx resolved;									Y	10/20/1995	10/20/1995	0		PVT	OTH	Chemotherapy drugs		ovarian cancer	~ ()~~~In patient	CO6269	1						2	Pruritus; Rash; Vasodilatation; Vomiting	FLU3~CONNAUGHT LABORATORIES~5F61114~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0078724	04/18/1997	OH	43.0	42		F	02/05/1997	vomiting, diarrhea, runny nose, coughing & diff breathing;was flushed & feverish;lasted a couple of hr & resolved;									Y	10/07/1995	10/08/1995	1		PVT	OTH	NONE	NONE	no allergy	~ ()~~~In patient	CO6162	1						2	Cough; Diarrhoea; Dyspnoea; Pyrexia; Rhinitis; Vasodilatation; Vomiting	FLU3~CONNAUGHT LABORATORIES~5F61127~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0078921	04/18/1997	AR	71.0	71		M	02/06/1997	myalgia, chills 12hr p/vax;malaise for 2 days;5 days post inj devel purpura of lower extremities & dec platelets, RBC & Hgb;platelets dec to 97,000;has resolved;									Y	11/04/1995	11/04/1995	0		PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	CO6325	1						2	Anaemia; Chills; Malaise; Myalgia; Purpura; Thrombocytopenia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0078937	04/18/1997	LA	22.0	22		M	02/05/1997	pain in axillia, proximal to humerus;no local erythema, swelling, some tenderness;no palpable nodes;				Y					U	10/23/1995	10/25/1995	2		PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient	CO6233	1						2	Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~5F61116~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0078981	04/18/1997	WI	44.0	44		F	02/06/1997	devel rash/hives, congestion & bronchial spasms;tx w/epi, inhaler, steroids & DPH in ER:				Y					Y	10/18/1995	10/18/1995	0		OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	CO6339	1						2	Asthma; Rash; Rhinitis; Urticaria	FLU3~CONNAUGHT LABORATORIES~5F61012~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0078982	04/18/1997	MD	37.0	37		M	02/06/1997	swollen arm, red, fever t104, severe arm discomfort, hot dizziness, t100.8 on 23OCT95;med started on 22OCT95;unk recovery status;									U	10/20/1995	10/20/1995	0		OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	CO6338	1						3	Dizziness; Hypokinesia; Myalgia; Oedema peripheral; Pyrexia; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61167~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~1076B~UNK~IM~LA~PNEUMO (PNEUMOVAX)~3	USA		Influenza
0079001	04/18/1997	TX	45.0	45		F	02/06/1997	angioedema & laryngospasm, itching all over, injected conjuntiva, dyspepsia;tx w/DPH & ventolin inhaler & responded to tx;still has asthma sx;									Y	11/06/1995	11/06/1995	0		PVT	OTH			hx of asthma & urticarial reactions;	~ ()~~~In patient	CO6312	1						2	Angioneurotic oedema; Conjunctivitis; Dyspepsia; Laryngospasm; Pruritus	FLU3~CONNAUGHT LABORATORIES~5F61014~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0079097	04/18/1997	NJ	44.0	43		M	02/06/1997	sneezing, runny nose & sore throat, arm sore;no fever;									Y	11/09/1995	11/10/1995	1		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	CO6323	1						2	Myalgia; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61014~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0079098	04/18/1997	WA	41.0	41		F	02/06/1997	raised rash bilat sides from underarm to hips, sl itching;tx w/DPH;									U	11/01/1995	11/02/1995	1		OTH	OTH	NONE	NONE	allergy to sulpa drugs;	~ ()~~~In patient	CO6347	1						2	Pruritus; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0079099	04/18/1997	NC	37.0	37		M	02/06/1997	arm brused w/apain & swelling from shoulder to elbow;now pain radiating down arm;fingers cold & numb;referred to ER of local hosp;				Y					U	10/16/1995	10/20/1995	4		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	CO6343	1						2	Ecchymosis; Myalgia; Oedema peripheral; Pain; Paraesthesia; Peripheral vascular disorder	FLU3~CONNAUGHT LABORATORIES~5F61166~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0079112	04/18/1997	TX	12.0	12		M	02/06/1997	raised lumps on wrist 24hr p/vax, no itching;48hr p/vax lumps spread to chest & other arm;tx w/DPH x 2 days w/o relief, also cutivate; .05% cream w/o relief;				Y					N	10/16/1995	10/17/1995	1		OTH	OTH	Tylaid, Benyln,PRN	NONE	Asthma	pt sibling @ 18mo had rxn to MMR vax;~ ()~~~In Sibling	CO6346	1						2	Skin nodule	FLU3~CONNAUGHT LABORATORIES~5F61166~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0079846	04/18/1997	MT	58.0	58		F	02/06/1997	started w/eating diff & tongue problems w/h/a on 9OCT95;temp & chills 10OCT;lt side face couldn't close eyes & numbness;tx in ER w/dx Bells Palsy-cause unk;unk recovery status;				Y					U	10/06/1995	10/08/1995	2		OTH	OTH	Estrogen, Progesterin	NONE	NONE	undescribed event 15 years ago p/flu vax;~ ()~~~In patient	CO6386	1						3	Anorexia; Chills; Eye disorder; Facial palsy; Headache; Paraesthesia; Pyrexia; Tongue disorder	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~UNKNOWN MANUFACTURER~~UNK~IM~LA~PNEUMO (NO BRAND NAME)~3	USA	Emergency room visit	Influenza
0079847	04/18/1997	NV	55.0	55		F	02/06/1997	numbness & tingling rt arm & hand & down leg & face-tightness tingling intermittant x2wk, mostly rt side, 1 day in lt hand;unk recovery status;									U	10/01/1995	10/01/1995	0		OTH	OTH	Premarin, Provera;	NONE	NONE	~ ()~~~In patient	CO6385	1						2	Hypertonia; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~5F61167~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0079848	04/18/1997	TX				M	02/06/1997	devel itching on chest, abd, neck & arms 48hr p/vax; some redness, sl rash;chloratrimitron x2 w/o relief;will try further doses;									U					OTH	OTH	NONE	NONE	tetracycline allergy;	~ ()~~~In patient	CO6384	1						3	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~~1~IM~LA~PNEUMO (PNEUMOVAX)~3	USA		Influenza
0079849	04/18/1997	TX	50.0	50		M	02/06/1997	devel hives,  redness on fce, neck & chest 1 day p/vax; also had h/a;tx w/DPH;									U	10/28/1995	10/30/1995	2		OTH	OTH			allergies	~ ()~~~In patient	CO6383	1						2	Headache; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61166~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0079850	04/18/1997	CA	32.0	32		F	02/06/1997	nausea rt p/vax;rash all over body in AM; will take DPH PO;									U	10/17/1995	10/18/1995	1		OTH	OTH	BCP, vit		hypoglycemia	~ ()~~~In patient	CO6381	1						2	Nausea; Rash	FLU3~CONNAUGHT LABORATORIES~5F61167~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0080110	04/18/1997	NE	33.0	33		F	02/06/1997	persistant arm soreness for 5wk since vax;pt stated could not lift 5yr old child nor raise lt arm above head;person think their inj was given incorrectly into a nerve;									N	11/03/1995	11/03/1995	0		PUB	PUB		NONE	NONE	~ ()~~~In patient	CO6421	1						2	Hypokinesia; Myalgia; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~5F61144~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0080127	04/18/1997	FL	44.0	44		M	02/06/1997	temp to 103.4 felt sl nauseated, weak & had severe piercing h/a;took APAP, temp went to 102.6 but wouldn't lower;called ER;to cold shower;take APAP 12NOV95 9AM temp 100, felt much improved but weak;									Y	11/11/1995	11/11/1995	0		PVT	PVT	Zantac;	NONE	No allergies, gastric ulcer	~ ()~~~In patient	CO6389	1						2	Headache; Myasthenic syndrome; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61117~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0080174	04/18/1997	IL	73.0	73		F	02/06/1997	pt recv vax & devel pneumonia & died on 31OCT95;pt reportedly had 5yr hx of heart problems, fibrotic lung disease, renal angioplasty & stroke;blood cult were negative;no autopsy was performed & the COD reported as pneumonia & resp arrest	Y	10/31/1995			Y				N	10/11/1995	10/15/1995	4		PVT	PVT	numerous		5yr hx of fibrotic lung disease, arteriosclerosis w/renal antioplasy, carotid enarterectomy, stroke;	pt exp pneumonia 1wk p/vax in 1994 w/flu vax~ ()~~~In patient	CO6416	1						2	Apnoea; Infection; Pneumonia	FLU3~CONNAUGHT LABORATORIES~5F61099~2~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0080701	04/18/1997	AZ	72.0	72		M	02/06/1997	achy legs & thighs w/low grade fever 10 days p/vax;temp goes up to 101 in afternoon & has the achy feeling;then around MN fever breaks & feels better until next day around non when sx reappear;									N	11/03/1995	11/13/1995	10		PVT	OTH	eye drops		NKA	pt recv flu vax for the past 25yr w/o incident;~ ()~~~In patient	CO6349	1						2	Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~7+~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0080997	04/18/1997	IA	61.0	61		M	02/06/1997	weak, dizzy, chest pain, cough, urinary discomfort;				Y					Y	12/26/1995	12/27/1995	1		PVT	OTH	Timoptic eye gtts	NONE	glaucoma	~ ()~~~In patient	CO6630	1						2	Asthenia; Chest pain; Cough; Dizziness; Dysuria	FLU3~CONNAUGHT LABORATORIES~5F61096~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0086540	04/18/1997	LA	2.0	2	.8	F	02/06/1997	fever of 104 5hr p/vax, then eyes rolling, pt was limp & was losing consciousness;pt was treated @ the ER & released;				Y					Y	10/09/1995	10/09/1995	0		PVT	PVT	Vantin	NONE	No allergies	~ ()~~~In patient	CO6631	1						2	Gaze palsy; Hypotonia; Pyrexia; Stupor; Gaze palsy; Hypotonia; Pyrexia; Stupor	FLU3~CONNAUGHT LABORATORIES~5F61082~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~1076E~1~IM~LA~PNEUMO (PNU-IMUNE)~2|FLU3~CONNAUGHT LABORATORIES~5F61032~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~0176E~1~IM~~PNEUMO (PNEUMOVAX)~3	USA	Emergency room visit	Influenza
0090385	04/18/1997	CO	30.0	29		M	02/06/1997	aches, fever to 102 x 2 days, h/a, delirious (disoriented);recovered 3 days;									Y	10/30/1995	10/30/1995	0		UNK	UNK				~ ()~~~In patient	CO6321	1						2	Confusional state; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~~UNK~~LA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0090386	04/18/1997	KY	70.0	70		F	02/06/1997	generalized tremors & visual disturbances, not resolved;									N	10/24/1995	10/31/1995	7		OTH	OTH				~ ()~~~In patient	CO6320	1						2	Tremor; Visual disturbance	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~~UNK~~~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0091302	04/18/1997	MD	30.0	29		F	02/06/1997	huge erythema, induration, itching around inj site w/some wheezing;subjective fever w/chills & aches & weakness;better by Sunday 12NOV95 morning;arm still very swollen & red 3 x 3 1/2;									U	11/10/1995	11/10/1995	0		PVT	OTH	NONE	NONE	allergy to cats, dander, dust;gets diarrhea from milk;	~ ()~~~In patient	CO6324	1						2	Asthenia; Asthma; Chills; Injection site hypersensitivity; Injection site mass; Injection site oedema; Myalgia; Pruritus; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61144~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0097088	04/18/1997	VA	78.0	78		F	02/06/1997	Bell's palsy on rt side;					Y				Y	11/24/1995	11/25/1995	1		PVT	OTH	Lopid, Micro K, Maxid;		hx of Bells palsy on lt side in 1985;hx of sinuitis in OCT95;HTN, hypercholestremia;	flu vax since 1986 w/o incident;~ ()~~~In patient	CO6360	1						1	Facial palsy	FLU3~CONNAUGHT LABORATORIES~5F61024~7+~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0097090	04/18/1997	KY	38.0			M	02/06/1997	possible anaphylactic rxn manifested by angioedema, HTN, abd pains, & tightness in chest;resolved p/tx w/steroids;			Y						Y	11/13/1995	11/13/1995	0		OTH	OTH		NONE	NONE	~ ()~~~In patient	CO6331	1						1	Abdominal pain; Anaphylactoid reaction; Angioneurotic oedema; Chest pain; Hypertension	FLU3~CONNAUGHT LABORATORIES~5F61006~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0097603	04/18/1997	NH	3.0	3		M		pt recv vax 8COT96 & 10OCT96 pt exp explosive diarrhea, which persisted for 4 days;it was followed by 3 days of vomiting ( 2 to 3 times per day);pt was very tired & had no appetite;									Y	10/08/1996	10/10/1996	2	No relevant data;	PVT	PVT	NONE		asthma, allergy, peanuts;	~ ()~~~In patient	WAES97020489	1						1	Anorexia; Asthenia; Diarrhoea; Vomiting	FLU3~PFIZER\WYETH~4968147~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|VARCEL~MERCK & CO. INC.~0834D~1~SC~~VARICELLA (VARIVAX)~1	USA		Influenza
0098293	04/18/1997	WV	70.0			U	02/06/1997	massive edema of entire arm & hand;vaccine given in arm of side where modified radical mastectomy preformed 18yr prior;									N	11/04/1995				UNK	UNK				~ ()~~~In patient	CO6344	1						1	Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~5F61126~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098298	04/18/1997	PA	25.0	25		F	02/06/1997	lightheadness, chills, faintness feeling, heart beating fast, high BP, talking fast, slurring words, not being able to say what was thinking;rxn subsided p/about 2hr;									Y	11/03/1995	11/03/1995	0		OTH	OTH	NONE	recovering from bonrchitis;	allergy to cats;	~ ()~~~In patient	CO6351	1						1	Chills; Dizziness; Hypertension; Speech disorder; Tachycardia	FLU3~CONNAUGHT LABORATORIES~5F61165~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098299	04/18/1997	MA				M	02/06/1997	dizziness & local rxn w/in 3hr of vax;noticed an eye floater;s/w opthalmologist who siad was harmless;									Y	11/22/1995	11/22/1995	0		OTH	OTH				~ ()~~~In patient	CO6355	1						1	Dizziness; Injection site reaction; Vitreous disorder	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098301	04/18/1997	SC	51.0	51		F	02/06/1997	bursitus like pain in lt shoulder & progressing mid-way dow medial aspect of arm to index finger & thumb into anterior wall;also has tingling & numbness sensation w/buring type pain;has presisted now for 3 1/2wk;tx meds;									Y	11/01/1995	11/03/1995	2		OTH	OTH		no recent illness	poss PCN allergy;	~ ()~~~In patient	CO6361	1						1	Arthralgia; Bursitis; Chest pain; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~5F61023~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098302	04/18/1997	FL		0	.0	F	02/06/1997	persistant strange dry cough in the PM p/vax w/some achiness;resolved by morning;									Y	11/15/1995	11/15/1995	0		OTH	OTH	NONE		no allergies	~ ()~~~In patient	CO6365	1						1	Cough; Myalgia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098304	04/18/1997	NY				U	02/06/1997	all muscles & joints on both lower extremities were extremely sore & was nable to walk, sit, or bend;the pains were so excrutiating htat pt had to take narcotics;									U	11/01/1995	11/02/1995	1		OTH	OTH				~ ()~~~In patient	CO6367	1						1	Arthralgia; Hypokinesia; Myalgia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098305	04/18/1997	FL	43.0	43		F	02/06/1997	constant coughing, tightness in throat, inflammation of eyes 2hr p/vax & lasted 24hr then resolved;									Y	11/15/1995	11/15/1995	0		OTH	OTH				~ ()~~~In patient	CO6368	1						1	Conjunctivitis; Cough; Laryngospasm	FLU3~CONNAUGHT LABORATORIES~5F61135~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098306	04/18/1997	WA				F	02/06/1997	swollen eyes, wheezing & fine red rash on face;									Y	11/14/1995	11/15/1995	1		OTH	OTH				~ ()~~~In patient	CO6370	1						1	Asthma; Face oedema; Rash	FLU3~CONNAUGHT LABORATORIES~5F61167~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098307	04/18/1997	PA	49.0	49		F	02/06/1997	h/a w/fever, then h/a progressively worse turning into migraine w/nausea;pt recovered;									Y	11/03/1995	11/03/1995	0		OTH	OTH				~ ()~~~In patient	CO6371	1						1	Headache; Migraine; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61165~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~CONNAUGHT LABORATORIES~5B71099~1~SC A~~MENINGOCOCCAL (MENOMUNE)~1	USA		Influenza
0098308	04/18/1997	CA	73.0	73		M	02/06/1997	gen vesicular rash began same day as vaccine; all over body, reddened halos w/scab formation in centers;appears like chickenpox;some areas still visable w/severe itching;				Y					U	11/08/1995	11/08/1995	0		PVT	OTH				~ ()~~~In patient	CO6372	1						1	Dermatitis bullous; Pruritus; Dermatitis bullous	FLU3~CONNAUGHT LABORATORIES~5F61120~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~5F61120~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0098308	04/18/1997	CA	73.0	73		M	02/06/1997	gen vesicular rash began same day as vaccine administered over entire body had reddened halos w/scab formation in centers;				Y					U	11/08/1995	11/08/1995	0		UNK	UNK				~ ()~~~In patient	CO6391	1						2	Dermatitis bullous; Pruritus; Dermatitis bullous	FLU3~CONNAUGHT LABORATORIES~5F61120~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~5F61120~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0098309	04/18/1997	CA	53.0	53		M	02/06/1997	dizzy & h/a 5min p/vax was feeling dehydrated all day w/dry mouth & achy all over & nausea;				Y					U	10/27/1995	10/27/1995	0		OTH	OTH				~ ()~~~In patient	CO6375	1						1	Dehydration; Dizziness; Dry mouth; Headache; Myalgia; Nausea	FLU3~CONNAUGHT LABORATORIES~5F61168~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098310	04/18/1997	TX	9.0	9		M	02/06/1997	swelling of entire lt arm w/heat, induration & erythema, but no pain or tenderness;seen & tx w/DPH & warm compresses;resolved by 29NOV95;				Y					Y	11/28/1995	11/29/1995	1		PVT	OTH				~ ()~~~In patient	CO6379	1						1	Oedema peripheral; Rash; Skin nodule; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61006~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098316	04/18/1997	NE				F	02/06/1997	hives in a non-egg protein sensitive person;				Y					U					OTH	OTH			able to eat eggs;	~ ()~~~In patient	CO6388	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098319	04/18/1997	MA	53.0	53		F	02/06/1997	gen malaise, aches, fever 100.4, lasted 24hr;then cold sx of sore throat, nasal congestion devel & lasted x 5 days;also GI sx 24hr p/vax consisted of diarrhea, abd cramps, nausea;									Y	10/30/1995	10/30/1995	0		OTH	OTH	Insulin, Synthroid, Vasotec, Lasix;	NONE	diabetes, HPN, hypothyroid;	~ ()~~~In patient	CO6392	1						1	Abdominal pain; Diarrhoea; Malaise; Myalgia; Nausea; Pharyngitis; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61126~4~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098320	04/18/1997	MA	49.0	49		F	02/06/1997	tenderness on the eve of vax in shoulder then following day noticd redness & swelling (size of mayonaise jar top) & fever & chills;t100.4, some nausea & dizziness;sx completely resolved 1wk p/starting;									Y	10/30/1995	10/30/1995	0		PUB	PVT	Premarin, Provera, Zestal	NONE	allergy to Percoce, Percodan, velapamil;	~ ()~~~In patient	CO6393	1						1	Chills; Dizziness; Nausea; Oedema; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~5F61126~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098321	04/18/1997	MA	24.0	24		F	02/06/1997	burning hot, itching rt arm, head felt heavy;									U	11/09/1995	11/09/1995	0		PUB	PUB	BCP	NONE	No allergies, has asthma (inhaler, PRN);	~ ()~~~In patient	CO6394	1						1	Headache; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098322	04/18/1997	MA	55.0	55		F	02/06/1997	abdo cramps, diarrhea 8hr p/vax for 48 hr, chills that resolved p/48hr then on 10NOV devel swollen lymph glands, sore throat, t100.6, gen malaise, fatigue, joint pain 3-4 days;only lingering aches remain;									Y	11/01/1995	11/01/1995	0		PUB	OTH	Premarin, Advil	NONE	PCN, 1st degree heart block, environmental asthma in the past;	~ ()~~~In patient	CO6395	1						1	Abdominal pain; Arthralgia; Asthenia; Chills; Diarrhoea; Lymphadenopathy; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F611126~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098323	04/18/1997	MA	53.0	53		F	02/06/1997	pain & numbness shooting pain down arm & elbow joint;swelling & tenderness under lt arm (axilla) & upper arm;As of 22NOV all resolved;									Y	11/02/1995	11/04/1995	2		PUB	OTH	Motrin	NONE	NONE	~ ()~~~In patient	CO6396	1						1	Arthralgia; Lymphadenopathy; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~5F61126~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098324	04/18/1997	MA	33.0	33		F	02/06/1997	lt upper arm swelling, red, sore & also noticed lt eye outer corner discomfort & lt outer ear 2 days p/vax; much improvement by 5 days p/vax;									U	11/01/1995	11/02/1995	1		PUB	OTH		dental treatment on lt side	NONE	~ ()~~~In patient	CO6397	1						1	Ear disorder; Eye disorder; Myalgia; Oedema peripheral; Rash	FLU3~CONNAUGHT LABORATORIES~5F61126~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098325	04/18/1997	MA	39.0	39		F	02/06/1997	metallic taste in mouth, furball throat, eyes bloodshot, discharged occasional pus, nauseous, lethargic, ache joints, shoulder joint sore, fever 102.3, chills about 6hr p/vax;									Y	11/07/1995	11/07/1995	0		PUB	OTH	Tegretol	NONE	IVP-dyes-severe reaction-coded;peilepsy	NONE~ ()~~~In patient	CO6398	1						1	Arthralgia; Chills; Conjunctivitis; Dysgeusia; Nausea; Pharyngitis; Pyrexia; Somnolence	FLU3~CONNAUGHT LABORATORIES~5F61126~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098326	04/18/1997	CO	59.0	59		M	02/06/1997	chills, h/a, malaise, vomiting, diarrhea, gen muscle pain, productive cough, sore throat;lasted approx 5-6hr;onset was 2-3hr p/vax;									Y	10/10/1995	10/10/1995	0		PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	CO6399	1						1	Chills; Cough; Diarrhoea; Headache; Malaise; Myalgia; Pharyngitis; Vomiting	FLU3~CONNAUGHT LABORATORIES~5F61116~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098327	04/18/1997	CO	28.0	28		F	02/06/1997	low grade fever, sore throat, swollen glands, achey body, cough, malaise;lasted 12 hr;									Y	10/16/1995	10/16/1995	0		PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	CO6400	1						1	Arthralgia; Cough; Lymphadenopathy; Malaise; Myalgia; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61116~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098328	04/18/1997	CO	34.0	34		M	02/06/1997	rash, cough, sore throat, malaise;lasted 6hr;									Y	10/19/1995	10/19/1995	0		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	CO6401	1						1	Cough; Malaise; Pharyngitis; Rash	FLU3~CONNAUGHT LABORATORIES~5F61116~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098329	04/18/1997	CO	44.0	44		F	02/06/1997	runny nose, neuralgia, nausea, sore throat;pt recovered;									Y	10/19/1995	10/19/1995	0		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	CO6402	1						1	Nausea; Neuralgia; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61116~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098330	04/18/1997	IA	24.0	23		F	02/06/1997	10min p/vax lightheaded, faint, pale, sweats for 10min;next morning subcutaneous swelling @ inj site size of baseball which lasted 3 days;									Y	11/07/1995	11/07/1995	0		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	CO6403	1						1	Dizziness; Hyperhidrosis; Injection site oedema; Pallor	FLU3~CONNAUGHT LABORATORIES~5F661006~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098331	04/18/1997	IA	50.0	49		F	02/06/1997	localized swelling, redness, warm (more like a hive), size 3 x 6 area still discolored 8NOV95;lasted 3-4 days;									Y	11/07/1995	11/07/1995	0		PVT	PVT	Premarin, Provera, Ibuprofen	NONE	Iodine allergy	~ ()~~~In patient	CO6404	1						1	Injection site hypersensitivity; Injection site oedema; Skin discolouration; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61006~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098332	04/18/1997	TX	50.0			F	02/06/1997	Malaise, h/a, body ache, sl cough, t99;12OCT95 fever blisters (actually began 11OCT), t101.5;14OCT same sx as 11OCT w/t101.5;able to work 15OCT & 16OCT w/fever in 99's & milder sx;									Y	10/08/1995	10/11/1995	3		PVT	PVT	NONE	NONE	allergic PCN & anti tetanus serum	~ ()~~~In patient	CO6408	1						1	Arthralgia; Cough; Headache; Malaise; Mouth ulceration; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61167~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098333	04/18/1997	TX	49.0			F	02/06/1997	fever blister, body aches, h/a;lasted approx 5-6 days;									Y	10/08/1995	10/08/1995	0		PVT	PVT	Premarin, Trazadone, DPH	NONE	allergies, PCN, IVP DYE, Demerol;hx fibromyalgia, mitral valve prolapse, FX-L;	~ ()~~~In patient	CO6409	1						1	Headache; Mouth ulceration; Myalgia	FLU3~CONNAUGHT LABORATORIES~5F61167~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098334	04/18/1997	TX	57.0			F	02/06/1997	weakness (unable to stand w/o support), body aches;lasted approx 2-3 days;off work 14OCT & 15OCT95;									Y	10/08/1995	10/09/1995	1		PVT	PVT	NONE	NONE	NONE	pt age 35 p/russian flu vax had nausea & vomiting;~ ()~~~In patient	CO6410	1						1	Hypokinesia; Myalgia; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~5F61167~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098335	04/18/1997	TX	44.0			F	02/06/1997	fever, chills, joint & muscle aches, coughing, sneezing;lasted approx 1wk;									Y	10/08/1995	10/09/1995	1		PVT	PVT	NONE	NONE	allergies:INH, wool & Environmental allergies cause hives;	~ ()~~~In patient	CO6411	1						1	Arthralgia; Chills; Cough; Myalgia; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61167~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098336	04/18/1997	LA	24.0	24		F	02/06/1997	transient episode of blurred vision lasting 10min the evening of vax;noticiable h/a afterwards;									Y	12/11/1995	12/11/1995	0		PVT	OTH	Deprovera in sept	NONE	no prior hx of this type of episode;no past head injury;no food or environmental changes;	pt recv flu vax in the past w/o incident;~ ()~~~In patient	CO6412	1						1	Amblyopia; Headache	FLU3~CONNAUGHT LABORATORIES~5F61082~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098338	04/18/1997	MA	70.0			M	02/06/1997	petechial rash covering both arms on hand on inj site;did a platelet count before & rt after the shot & was down significantly;									U					UNK	UNK				~ ()~~~In patient	CO6422	1						1	Petechiae; Rash; Thrombocytopenia	FLU3~CONNAUGHT LABORATORIES~5F61134~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098339	04/18/1997	ID	57.0	57		F	02/06/1997	15cm diameter, red, indurated, tender loacl rxn;achy & not feeling good but MD feels aches may not be attributable to vaccine;				Y					U	12/18/1995	12/18/1995	0		OTH	OTH				~ ()~~~In patient	CO6423	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Malaise; Myalgia	FLU3~CONNAUGHT LABORATORIES~5J61007~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098340	04/18/1997	TX	74.0			M	02/06/1997	devel pain in shoulder, down to hand, then hip 2 days p/vax;hands & fingers swollen & painful;in good hlth prior w/no hx of arthritis or other problems;									U					OTH	OTH				~ ()~~~In patient	CO6430	1						1	Arthralgia; Oedema peripheral; Pain	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098341	04/18/1997	MO				F	02/06/1997	swelling in hands & legs assoc w/numbness 5 days post inj;resolved w/o sequale in 2mo;MD feels may have been viral in nature;				Y					Y	10/17/1994	10/22/1995	370		OTH	OTH	unk	unk	unk	~ ()~~~In patient	CO6437	1						1	Oedema peripheral; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~5F61126~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098342	04/18/1997	TN	71.0			M	02/06/1997	optic neuritis, bilat;tx w/steroids & recovered w/in 3wk tx;				Y					Y		12/02/1995			OTH	OTH	Zestril, Axid, Tamazipam, hydrocloridiazid;	NONE	HTN, ulcers, no significant ocular hx;	~ ()~~~In patient	CO6455	1						1	Optic neuritis	FLU3~CONNAUGHT LABORATORIES~5F61093~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098343	04/18/1997	NC	3.0	3		F	02/06/1997	aches, vomiting, cough, fever;									Y	10/25/1995	10/26/1995	1		PVT	PVT	Intal, Ventolin, Beclovent;	Wari	NONE	NONE~ ()~~~In patient	CO6496	1						1	Cough; Myalgia; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~5F61166~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098344	04/18/1997	KY	33.0			F	02/06/1997	signs of tremors & weakness which persists since vax given in 1994;pt believes has GBS & says MD can not r/o;has appointment w/neuro next month MAR96;needs walker to ambulate;has had several bouts of depression & has attempted suicide									U	11/07/1994	11/17/1994	10		UNK	UNK				~ ()~~~In patient	CO6500	1						1	Asthenia; Depression; Guillain-Barre syndrome; Hypokinesia; Suicide attempt; Tremor	FLU3~CONNAUGHT LABORATORIES~4F51015~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098348	04/18/1997	NY	83.0			M	02/06/1997	pt recv vax & devel poss GBS;hosp the day p/vax w/transient weakness & inability to walk or move from neck down;tx w/steroids & IGG;did not require mechanical ventilation;still not able to walk on own as of 30NOV95 but will be transferred				Y	Y				N	11/03/1995	11/07/1995	4		PVT	OTH	Ziac		hx of CA of lung, tx by pneumonectomy	flu & pneumovax in 94 w/o incident;~ ()~~~In patient	CO6373	1						1	Guillain-Barre syndrome; Hypokinesia; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~5F61014~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0098739	04/18/1997	OH	41.0			F	02/05/1997	local rxn that was red, hot to touch about the size of a silver dollar;									U	10/31/1995	10/31/1995	0		OTH	OTH				prior flu vax w/o problem;~ ()~~~In patient	CO6270	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61099~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098740	04/18/1997	OH	41.0			F	02/05/1997	local rxn of red, hot to touch; silver dollar size;									U	10/31/1995	10/31/1995	0		OTH	OTH				flu vax in the past w/o problem;~ ()~~~In patient	CO6271	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61099~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098741	04/18/1997	OH	48.0	48		M	02/05/1997	significant local rxn; looked like cellulitis;entire upper arm, shoulder to elbow, red, hard, warm to touch, febrile 101;area also ecchymotic;				Y					U	10/31/1995	11/01/1995	1		PVT	OTH	Ativan, Chemotherapy	Leukemia	Leukemia, in partial  remission	~ ()~~~In patient	CO6273	1						1	Cellulitis; Ecchymosis; Injection site hypersensitivity; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61099~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098752	04/18/1997	PA	47.0	47		F	02/06/1997	site extremly red, swollen & painful;chills, h/a & achy feeling;vaccine in the past w/o problem;									U	10/31/1995	10/31/1995	0		OTH	OTH				flu vaccine in the past w/o problem;~ ()~~~In patient	CO6295	1						1	Chills; Headache; Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098753	04/18/1997	TX				F	02/06/1997	both arms heavy;could not hold a pen;numbness & tingling in arms w/some tingling in legs;				Y					U	10/27/1995	10/29/1995	2		OTH	OTH			no relevant past history	said had lesser but similar sx 1994 p/flu vax;~ ()~~~In patient	CO6299	1						1	Hypotonia; Myasthenic syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~5F61133~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098754	04/18/1997	ME	30.0			F	02/06/1997	sore arm & sub-clavicular nodes;									U	10/25/1995	10/26/1995	1		OTH	OTH				~ ()~~~In patient	CO6301	1						1	Lymphadenopathy; Myalgia	FLU3~CONNAUGHT LABORATORIES~5F61143~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098755	04/18/1997	ME	40.0			F	02/06/1997	sore arm w/hard, indurated area;									U	10/25/1995	10/26/1995	1		UNK	UNK				~ ()~~~In patient	CO6302	1						1	Myalgia; Skin nodule	FLU3~CONNAUGHT LABORATORIES~5F61143~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098756	04/18/1997	TX	41.0	41		F	02/06/1997	started as diff swollowing 3hr p/vax;then thraot swollen, stridor 45min later w/achyness & inc temp 3-4hr later;resolved p/taking Codinal;@ work next day & only feels tired;no other changes in habits;1st time for flu vax;									Y	11/06/1995	11/06/1995	0		OTH	OTH	NONE	NONE	allergy to PCN;no hx of asthma;	~ ()~~~In patient	CO6304	1						1	Asthenia; Chills; Dysphagia; Laryngospasm; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61112~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098757	04/18/1997	PR	35.0			M	02/06/1997	moderte dehydration, abd pain, gastritis, PVC's, fever 99.5;				Y					U	11/03/1995	11/05/1995	2		MIL	MIL				~ ()~~~In patient	CO6307	1						1	Abdominal pain; Dehydration; Gastritis; Pyrexia; Ventricular extrasystoles	FLU3~CONNAUGHT LABORATORIES~5J61007~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098758	04/18/1997	CA	43.0	43		M	02/06/1997	dx GBS;received letter from pt who was told to report;addtl details requested;									Y	10/03/1995	10/16/1995	13		OTH	OTH				~ ()~~~In patient	CO6308	1						1	Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098759	04/18/1997	WV	69.0	68		F	02/06/1997	severe shaking all over & severe aches & pains from waist down;temp nl;treated w/DPH;well a/vaccine;prior flu vax w/o problem;				Y					U	11/08/1995	11/08/1995	0		UNK	UNK	Cardura, Lorazipam, estro TAB, Varlin		no allergy	~ ()~~~In patient	CO6309	1						1	Myalgia; Pain; Tremor	FLU3~CONNAUGHT LABORATORIES~5F61116~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098760	04/18/1997	MD				M	02/06/1997	significant swelling & erythema around inj site;numbness in lt little finger & diff moving;									U	11/08/1995	11/08/1995	0		OTH	OTH				~ ()~~~In patient	CO6310	1						1	Injection site hypersensitivity; Injection site oedema; Movement disorder; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~5J6107~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098761	04/18/1997	MD				F	02/06/1997	significant swelling & erythema around inj site;better as of 9NOV95;									Y	11/08/1995	11/08/1995	0		OTH	OTH				~ ()~~~In patient	CO6311	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~5J61007~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098763	04/18/1997	PA				F	02/06/1997	inj site red the size of a quarter, tender & painful;									U	11/08/1995	11/09/1995	1		OTH	OTH				~ ()~~~In patient	CO6313	1						1	Injection site hypersensitivity; Injection site pain	FLU3~CONNAUGHT LABORATORIES~5F61014~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098764	04/18/1997	PA	37.0	37		F	02/06/1997	red, hot area on arm 3 in diameter;									Y	11/01/1995	11/02/1995	1		OTH	OTH	Asthmacort		chronic asthma, allergies to grass, ca dander;	~ ()~~~In patient	CO6319	1						1	Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61165~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~CONNAUGHT LABORATORIES~5E71036~2~SC~RA~MENINGOCOCCAL (MENOMUNE)~1	USA		Influenza
0098770	04/18/1997	CO	27.0	27		M	02/06/1997	painful rash on back & arm 3-4 area of redness;also rash on wrist & belt line;will be seen;				Y					U	11/10/1995	11/11/1995	1		PUB	OTH	Lithiu, Wellbutrin			~ ()~~~In patient	CO6326	1						1	Injection site hypersensitivity; Rash	FLU3~CONNAUGHT LABORATORIES~~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098771	04/18/1997	VT	47.0			F	02/06/1997	eyes very red, itchy & watery;dry mouth, felt like object in throat 1hr p/vax;persistent cough;BP fine, P=fine;called MD who sent to ER;tx w/DPH;throat better;6PM devel temp 100.6 & was achy;nothing unusual to eat or drink;				Y					Y	11/09/1995	11/09/1995	0		OTH	OTH	NONE	NONE	allergy to tetracycline	~ ()~~~In patient	CO6327	1						1	Conjunctivitis; Cough; Dry mouth; Lacrimal disorder; Laryngospasm; Myalgia; Pruritus; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61024~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098772	04/18/1997	MN	50.0			F	02/06/1997	pain in lt hand w/in 2-3hr of vax;later devel problem w/lt eye moving slowly;BP 210/98 @ the time of visit to employee clinic;instructed to f/u w/usual physician because of past hx of HTN;									U	10/31/1995	10/31/1995	0		OTH	OTH			hx of HPN & prev kidney function workup	~ ()~~~In patient	CO6329	1						1	Condition aggravated; Eye disorder; Pain	FLU3~CONNAUGHT LABORATORIES~5F61163~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098773	04/18/1997	FL	45.0			F	02/06/1997	2 rash around inj site, hot & burning then itching;									Y	10/17/1995	10/20/1995	3		PVT	PVT	Altace	NONE	high BP	~ ()~~~In patient	CO6332	1						1	Injection site hypersensitivity; Injection site pain; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61014~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098774	04/18/1997	FL	52.0			M	02/06/1997	red, swollen, tender area on inj site;									Y	10/17/1995	10/20/1995	3		PVT	UNK				~ ()~~~In patient	CO6333	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~5F61014~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098775	04/18/1997	FL	50.0	50		F	02/06/1997	sl swelling & redness;									Y	10/17/1995				PVT	OTH				~ ()~~~In patient	CO6334	1						1	Oedema; Rash	FLU3~CONNAUGHT LABORATORIES~5F61014~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098776	04/18/1997	FL	37.0	37		F	02/06/1997	severe h/a, body aches, red, swollen shoulder w/temp of 3 1/2 days;									Y	10/18/1995	10/18/1995	0		PVT	OTH				~ ()~~~In patient	CO6335	1						1	Headache; Myalgia; Oedema; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~5F61014~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098777	04/18/1997	NY	33.0	33		F	02/06/1997	severe pain @ the site of inj & throughout the entire shoulder & arm for 2 dasy;no swelling or fever;									Y	10/15/1995	10/15/1995	0		PVT	PVT	NA	NONE	NONE	~ ()~~~In patient	CO6336	1						1	Injection site pain; Pain	FLU3~CONNAUGHT LABORATORIES~5F61145~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098778	04/18/1997	NC	41.0	41		F	02/06/1997	flushed skin, lightheadedness & red blotches all over chest;									U	11/14/1995	11/14/1995	0		MIL	MIL				~ ()~~~In patient	CO6337	1						1	Dizziness; Rash maculo-papular; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5J61034~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098779	04/18/1997	LA	29.0	29		F	02/05/1997	face red w/burning, then next day face peeled, dry & flakey, inject site red & raised;									U	10/13/1995	10/14/1995	1		OTH	OTH	NONE		PCN	~ ()~~~In patient	CO6208	1						1	Dermatitis exfoliative; Dry skin; Injection site hypersensitivity; Injection site oedema; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098780	04/18/1997	OK	41.0	41		F	02/05/1997	rash on rt arm w/vesicles that spread all over;had fever & malaise;As of 17OCT95 just starting to feel better;father is MD & prescribed steroids;mom also had rxn;				Y					U	10/08/1995	10/09/1995	1		OTH	MIL	Prozac		allergy to PCN, wheat & dairy products	~ ()~~~In patient	CO6209	1						1	Dermatitis bullous; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098781	04/18/1997	PA	66.0	66		F	02/05/1997	angioedema of neck, then over body;taken to ER & treated w/pred;As of 17OCT95 still has some rxn;				Y					U	10/08/1995	10/09/1995	1		OTH	OTH	Thyroid med		environmental allergies;	~ ()~~~In patient	CO6210	1						1	Angioneurotic oedema	FLU3~CONNAUGHT LABORATORIES~~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098782	04/18/1997	MD	23.0			F	02/05/1997	lightheadness, diplopia, felt warm & inc BP 150/90;									Y	10/16/1995	10/17/1995	1		OTH	OTH			no allergy history	~ ()~~~In patient	CO6212	1						1	Diplopia; Dizziness; Hypertension; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098784	04/18/1997	TX	52.0			F	02/05/1997	face, lips & arm swollen w/in 10hr, feeling bad;tx w/Medrol dose pak;many flu vax in the past w/o incidents;									Y	10/09/1995	10/10/1995	1		OTH	OTH	high BP pills		high BP	~ ()~~~In patient	CO6214	1						1	Face oedema; Malaise; Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~5F61133~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098785	04/18/1997	TN	53.0	53		F	02/05/1997	h/a, achy, soreness in thrat w/tingling;sore arm w/red area about quarter size;				Y					Y	10/18/1995	10/19/1995	1		OTH	OTH	Aluprit, premerin, thyroid, diuretic;		non-specific allergies uses nasal spray PRN	~ ()~~~In patient	CO6215	1						1	Headache; Myalgia; Paraesthesia; Pharyngitis; Rash	FLU3~CONNAUGHT LABORATORIES~5F61117~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098786	04/18/1997	MO	31.0	31		F	02/05/1997	raised, hot welt @ site, achy but no fever;									U	10/17/1995	10/19/1995	2		PUB	OTH			no allergy hx	~ ()~~~In patient	CO6216	1						1	Injection site hypersensitivity; Injection site mass; Myalgia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61099~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098787	04/18/1997	NV				F	02/05/1997	rah on neck & both axillary areas, no other sx;tx w/DPH;									U	10/17/1995	10/18/1995	1		OTH	OTH				~ ()~~~In patient	CO6217	1						1	Rash	FLU3~CONNAUGHT LABORATORIES~5F61143~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098789	04/18/1997	NY	78.0	78		M	02/05/1997	arm was red, swollen & very warm evening p/vax;				Y					Y	10/18/1995	10/18/1995	0		PVT	OTH			no allergies	pt recv flu vax 2yr ago w/o incident;~ ()~~~In patient	CO6221	1						1	Oedema peripheral; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F6115~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098790	04/18/1997	TN	73.0			F	02/05/1997	numbness & tingling of legs starting about noon, 19OCT95;next day, 19OCT95 very noticable;seen 20OCT95 no motor deficit;DTR nl;muscle strength nl;paresthesia extends toes to buttocks bilat;				Y					U	10/17/1995	10/18/1995	1		OTH	OTH	Hypertension meds		allergy to PCN, formalin & PPD-A	~ ()~~~In patient	CO6223	1						1	Paraesthesia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098791	04/18/1997	NE	18.0	18		F	02/05/1997	pale, clammy, responded to voices 5min p/vax; BP @ 2min intervals: 114/72, 116/74, 112/72 p/45min became alert, warm & dry;									Y	10/08/1995	10/08/1995	0		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	CO6224	1						1	Hyperhidrosis; Hypotension; Pallor	FLU3~CONNAUGHT LABORATORIES~5F61167~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098792	04/18/1997	CA	49.0	49		F	02/05/1997	swollen tongue & sore throat;seen in ER & tx w/epi, anti histamines & steroids;				Y					Y	10/10/1995	10/10/1995	0		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	CO6225	1						1	Pharyngitis; Tongue oedema	FLU3~CONNAUGHT LABORATORIES~5F61167~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098794	04/18/1997	OH	40.0	40		F	02/05/1997	itchy @ site w/in 5min of inj;then 4x4 area of redness no systemic rxn;									Y	10/20/1995	10/20/1995	0		PVT	OTH	NONE	NONE	environmental allergies, PCN	~ ()~~~In patient	CO6229	1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~5F61167~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098797	04/18/1997	CA	22.0	22		F	02/05/1997	fever of 101.5 w/flu-like sx;off work w day;back @ work on 26OCT95 still expressing dull ache in back of head;									Y	10/23/1995	10/23/1995	0		OTH	OTH	NONE	NONE	NONE	last yr pt had similar rxn;~ ()~~~In patient	CO6236	1						1	Headache; Influenza; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61116~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098800	04/18/1997	IA	46.0	46		F	02/05/1997	chest tightness, watery eyes, congestion, cough, malaise w/in hr of vax 3PM f/u cont coughing since vax recv;will see own MD for addtl f/u;				Y					N	10/25/1995	10/25/1995	0		OTH	OTH	unk	NONE	no allergy to foods or medication;contace allergy to eye make-up	~ ()~~~In patient	CO6239	1						1	Chest pain; Cough; Lacrimal disorder; Malaise; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61015~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098803	04/18/1997	NY	58.0	58		F	02/05/1997	diarrhea & rash between fingers;									U	10/25/1995	10/25/1995	0		OTH	OTH				~ ()~~~In patient	CO6243	1						1	Diarrhoea; Rash	FLU3~CONNAUGHT LABORATORIES~5F61165~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098804	04/18/1997	GA	33.0	33		M	02/05/1997	hive 6-8hr p/vax itchy hands;									Y	10/25/1995	10/25/1995	0		OTH	OTH	NONE		may be immunosupressed	~ ()~~~In patient	CO6244	1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~5F6114~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098805	04/18/1997	IL				F	02/05/1997	reddened area on axilla to hand, but nothing local;									U	10/19/1995	10/21/1995	2		OTH	OTH				bad rxn 3yr ago;~ ()~~~In patient	CO6245	1						1	Rash	FLU3~CONNAUGHT LABORATORIES~5F61143~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098806	04/18/1997	MD	40.0	40		F	02/05/1997	fever 103 8hr post inj;fever cont as of 27OCT95, 100.4;generalized body aches, productive cough (yellow mucous) & nausea;will be seen by MD today 28OCT95;				Y					N	10/23/1995	10/23/1995	0		OTH	OTH	APAP	cold for several weeks	NONE	~ ()~~~In patient	CO6246	1						1	Cough; Myalgia; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5J61007~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098807	04/18/1997	FL				U	02/05/1997	fainted immed p/inj;dizzy fell to ground was disoriented for a few min;recovered w/in min & was fine;prev incidence of faint during pregnancy;had nothing to eat prior to vax administration;									Y	10/25/1995	10/25/1995	0		PVT	OTH	oral contraceptives, clariton		allergies to dust & pollen	~ ()~~~In patient	CO6247	1						1	Confusional state; Dizziness; Syncope	FLU3~CONNAUGHT LABORATORIES~5F61166~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098808	04/18/1997	FL				F	02/05/1997	whole arm swollen & persists & is getting worst;				Y					N	10/13/1995	10/17/1995	4		UNK	UNK				~ ()~~~In patient	CO6250	1						1	Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098809	04/18/1997	CT	66.0	66		F	02/05/1997	local rxn of redness, 3 1/2 x 2;									U	10/25/1995	10/26/1995	1		OTH	OTH				~ ()~~~In patient	CO6251	1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~5F61149~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098810	04/18/1997	CT	73.0	73		F	02/05/1997	local rxn of redness 3 1/2 x 2 1/2;									U	10/25/1995	10/26/1995	1		OTH	OTH				~ ()~~~In patient	CO6252	1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~5F61149~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098811	04/18/1997	CT	23.0			M	02/05/1997	immed pallor, sweating, BP 80/50, heart rate 50, dizzy;given adrenalin 1:1000, 0.4ml SC;recovered almost as fast as incident;refused paramedic help;									Y	10/11/1995	10/11/1995	0		OTH	OTH			no allergies	~ ()~~~In patient	CO6254	1						1	Bradycardia; Dizziness; Hyperhidrosis; Hypotension; Pallor	FLU3~CONNAUGHT LABORATORIES~5F61012~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098812	04/18/1997	TX	48.0	48		M	02/05/1997	nausea, vomiting & tiredness;									N	10/24/1995	10/26/1995	2		OTH	OTH	Vitamins	healthy male	no allergy hx	~ ()~~~In patient	CO6255	1						1	Asthenia; Vomiting	FLU3~CONNAUGHT LABORATORIES~5F61168~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098813	04/18/1997	PA	49.0	49		M	02/05/1997	fever, felt achy, eyes burning & red;next day fine;									Y	10/24/1995	10/24/1995	0		OTH	OTH	HTN med		no allergies;	many flu shots since 1974 w/o incident;~ ()~~~In patient	CO6256	1						1	Conjunctivitis; Eye pain; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61145~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098814	04/18/1997	AR	31.0	30		F	02/05/1997	rashes from elbow to shoulder;treated w/ice & resolved;									Y	10/16/1995	10/16/1995	0		PVT	PVT	Coumadin		cardiomyopathy, mitral valve prolapse, asthma as a child	NONE~ ()~~~In patient	CO6258	1						1	Rash	FLU3~CONNAUGHT LABORATORIES~5F61099~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098815	04/18/1997	AR	42.0	42		F	02/05/1997	arm & face swelling;seen in ER;				Y					Y	10/30/1995	10/30/1995	0		PVT	PVT	Coumadin		mitral valve regurge, rheumatic heart disease;no egg allergy;	NONE~ ()~~~In patient	CO6259	1						1	Face oedema; Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~5F61099~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098816	04/18/1997	OH	55.0			M	02/05/1997	migratory arthralgias, not able to make fist w/rt hand (vax in lt deltoid);pain in lt knee & hips;				Y					N	10/13/1995	10/15/1995	2		MIL	MIL				~ ()~~~In patient	CO6263	1						1	Arthralgia; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098817	04/18/1997	NJ	1.7	1	.7	F	02/05/1997	patchy vesicular rash radiating from inj site outwards towards groin & to knee;started as rash around site & becoming progressive more extensive;mom though looked like poision ivy;31JAN96 f/u w/MD probably was poision ivy;				Y					N	10/20/1995	10/24/1995	4		PVT	PVT			prematurity, BPD as a result of being in incubator;	~ ()~~~In patient	CO6264	1						1	Dermatitis bullous; Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~5F61014~2~L~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098818	04/18/1997	MN	24.0	24		M	02/05/1997	generalized hives w/swelling of hands & feet;resolved by time of MD visit;				Y					Y	10/26/1995	10/28/1995	2		OTH	OTH				~ ()~~~In patient	CO6267	1						1	Oedema peripheral; Urticaria	FLU3~CONNAUGHT LABORATORIES~5F61014~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098819	04/18/1997	CT	18.0	18		M	02/05/1997	diaphoretic, thready pulse, hypotensive & passed out w/in 60 sec of vax;									Y	10/28/1995	10/28/1995	0		OTH	OTH	NONE			pt exp prior hx of fainting w/any type of shot or blood work~ ()~~~In patient	CO6268	1						1	Bradycardia; Hyperhidrosis; Hypotension; Syncope	FLU3~CONNAUGHT LABORATORIES~5F61167~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098872	04/18/1997	MI	70.0	70		M	02/05/1997	rash;almost herpes zoster like 4-5 days p/vax;				Y					N	09/13/1995	09/17/1995	4		UNK	UNK		NONE, but has COPD	COPD	~ ()~~~In patient	CO6137	1						1	Dermatitis bullous	FLU3~CONNAUGHT LABORATORIES~5F61112~7+~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098873	04/18/1997	GA	44.0	44		M	02/05/1997	projectile vomiting, shaking, chills & rigors w/dry cough, sinusitis, flu-like h/a;unable to eat for 2 days;slowly improving;able to take fluids now;									U	09/27/1995	09/28/1995	1		PVT	OTH	NONE	NONE	No allergies	~ ()~~~In patient	CO6140	1						1	Chills; Cough; Dehydration; Headache; Influenza; Sinusitis; Vomiting	FLU3~CONNAUGHT LABORATORIES~5F61023~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098874	04/18/1997	GA				F	02/05/1997	flu-like sx;still unwell p/2 days;									U	09/27/1995	09/28/1995	1		PVT	UNK				~ ()~~~In patient	CO6141	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~5F61023~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098875	04/18/1997	FL	37.0	37		F	02/05/1997	rash & hives on legs & arms;				Y					U	09/29/1995	10/01/1995	2		PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient	CO6145	1						1	Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~5F61150~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098876	04/18/1997	TN	44.0	44		M	02/05/1997	rash on face, eye swollen, h/a, vomiting;As of 4OCT95, eyes still swollen & sl h/a;				Y					U	10/03/1995	10/03/1995	0		PVT	OTH	NONE	NONE	allergy to codeine	~ ()~~~In patient	CO6152	1						1	Face oedema; Headache; Rash; Vomiting	FLU3~CONNAUGHT LABORATORIES~5F61167~2~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098877	04/18/1997	CA	32.0	32		F	02/05/1997	rash, hives, red all over, itching, tongue & lips were numb & burning from the itching, feeling of being hot, metallic taste in mouth;tx w/med;				Y					Y	10/02/1995	10/03/1995	1		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	CO6158	1						1	Dysgeusia; Pain; Paraesthesia; Pruritus; Rash; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61143~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098878	04/18/1997	TX	52.0			F	02/05/1997	began w/laryngitis, chills & fever, diarrhea until 5OCT95, joint pains;									U	10/02/1995	10/03/1995	1		PUB	OTH				~ ()~~~In patient	CO6159	1						1	Arthralgia; Chills; Diarrhoea; Laryngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61119~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098879	04/18/1997	IL	68.0	68		F	02/05/1997	swelling of lower lip about 4-6hr p/vax;no SOB, dysphiga or tongue swelling;				Y					Y	09/27/1995	09/27/1995	0		PUB	UNK	Motrin, EC-ASA, Atenolol, Isordil	NONE	HTN, NIDDM, MI	~ ()~~~In patient	CO6160	1						1	Face oedema	FLU3~CONNAUGHT LABORATORIES~5F61119~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098882	04/18/1997	OH				F	02/05/1997	tightness in chest, congested, achy, joint pains;persists as of 9OCT95;									U	10/07/1995	10/08/1995	1		PVT	OTH	unk		unk	~ ()~~~In patient	CO6163	1						1	Arthralgia; Chest pain; Myalgia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~5F61127~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098883	04/18/1997	FL				F	02/05/1997	persistent dysphonia since last yer (94-95 season) vax; evaluated by 8 different physicians;no on Klonopin w/ 50% improvement in voice quality;				Y					N					UNK	UNK				~ ()~~~In patient	CO6165	1						1	Dysphonia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098884	04/18/1997	GA	50.0			F	02/05/1997	drowsiness, heart racing, myalgia in legs & arms w/jerky movement;gen chills, felt hot;took APAP & theraflu & then had urinary urgency & frequency & jaw muscles felt tight;7OCT95 only felt fatigued;8OCT95 just felt weak w/some sore throat;				Y					Y	10/06/1995	10/06/1995	0		PVT	OTH		NONE	allergies to chocolate, MSG OTC cold med;	~ ()~~~In patient	CO6166	1						1	Hypertonia; Muscle twitching; Myalgia; Pharyngitis; Pollakiuria; Pyrexia; Somnolence; Tachycardia	FLU3~CONNAUGHT LABORATORIES~~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098885	04/18/1997	NC	44.0	43		M	02/05/1997	rasied red area, size of baseball resolved of 9OCT95;									Y	10/06/1995	10/07/1995	1		OTH	OTH	NONE	NONE	no allergies	~ ()~~~In patient	CO6167	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~5F61163~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098886	04/18/1997	NC	55.0	55		F	02/05/1997	itchy, raised area resolved;									Y	10/04/1995	10/05/1995	1		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	CO6168	1						1	Injection site oedema; Pruritus	FLU3~CONNAUGHT LABORATORIES~5F61163~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098887	04/18/1997	TX	3.0	3		F	02/05/1997	red raised patch on cheek & spread to extremities & trunk;persist as of 10OCT95;									U	10/06/1995	10/07/1995	1		UNK	UNK				~ ()~~~In patient	CO6172	1						1	Rash; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~5F61097~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098889	04/18/1997	NJ	40.0	40		F	02/05/1997	localized rxn  w/fever, muscle aches & pains;				Y					Y	10/06/1995	10/08/1995	2		PVT	OTH	NONE	NONE	frequent bronchitis, allergic rhinitis	~ ()~~~In patient	CO6181	1						1	Injection site reaction; Myalgia; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61133~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~~1~~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0098891	04/18/1997	IL	49.0	49		F	02/05/1997	stabbing pain over lt breast more twoards sterum;breaking out clammy sweat w/nausea;									U	10/09/1995	10/11/1995	2		OTH	OTH	Timentin, Premarin, Provera	NONE	mitral valve prolpse, HTN	~ ()~~~In patient	CO6183	1						1	Hyperhidrosis; Nausea; Pain	FLU3~CONNAUGHT LABORATORIES~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098892	04/18/1997	FL	31.0	31		F	02/05/1997	mouth, lips swollen w/in 4hr;throat getting dry;NKDA;has food allergies to eggplant & rubara;lips swell;had seafood salad for lunch;				Y					U	10/13/1995	10/13/1995	0		PVT	UNK		NONE	allerty to eggplant, rubarb;gets lip swelling;	~ ()~~~In patient	CO6184	1						1	Face oedema; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~5F61143~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098893	04/18/1997	CO	44.0	44		F	02/05/1997	not feeling well w/in 4hr ov vax;in 8hr had protracted nausea & vomiting & sense of impending doom;seen in ER & give antinausea med; fine by 12OCT95;				Y					Y	10/11/1995	10/11/1995	0		PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient	CO6185	1						1	Depersonalisation; Malaise; Vomiting	FLU3~CONNAUGHT LABORATORIES~5F61145~6~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098894	04/18/1997	MO				F	02/05/1997	underarm sore & swollen; can't move arm;									U	10/10/1995	10/12/1995	2		OTH	OTH			lots of allergies;	~ ()~~~In patient	CO6187	1						1	Hypokinesia; Lymphadenopathy; Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098895	04/18/1997	FL	42.0	42		F	02/05/1997	local rxn & tender, egg sized lump;hot to touch in axilla w/in 8-10hr of vax;				Y					U	10/11/1995	10/11/1995	0		PUB	OTH	NONE	NONE	NONE	flu vax in past w/o problem;~ ()~~~In patient	CO6188	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Lymphadenopathy; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61095~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098896	04/18/1997	TX				F	02/05/1997	morbiliform pruritic rash w/anterior lymphadenopathy 24hr p/vax;no other sx;									U					PVT	PVT		NONE	hx of rash rx p/viral illness	~ ()~~~In patient	CO6190	1						1	Lymphadenopathy; Pruritus; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098897	04/18/1997					F	02/05/1997	chills & sweating 6hr p/vax;no local rxn;much better now;									Y	10/11/1995	10/12/1995	1		OTH	OTH				~ ()~~~In patient	CO6191	1						1	Chills; Hyperhidrosis	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098898	04/18/1997	MN	30.0			F	02/05/1997	local rxn warm & hot to touch, throat scratchy, hollow-heeaded feeling w/in a few hr of vax;next day h/a;									Y	10/12/1995	10/12/1995	0		OTH	OTH	NONE		no allergies	~ ()~~~In patient	CO6195	1						1	Headache; Injection site reaction; Pharyngitis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61097~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098899	04/18/1997	MN	30.0			F	02/05/1997	hot sore throat, scratchy;hollow-headed feeling;h/a;									Y	10/12/1995	10/12/1995	0		OTH	OTH				~ ()~~~In patient	CO6196	1						1	Headache; Pharyngitis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~5F61097~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098900	04/18/1997	CA	71.0			U	02/05/1997	urticarial rxn @ the site of the inj;looked like hives, very pruritic, non-tender w/erythema;occurred w/in 8-10hr of vax;tx w/DPH but kept growing in size over 2-3 days;treated by allergist w/steroids w/relief by 16OCT95;				Y					Y	10/12/1995	10/12/1995	0		PVT	OTH				~ ()~~~In patient	CO6197	1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~5F61097~UNK~~GM~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098901	04/18/1997	CA				U	02/05/1997	urticarial rash @ site of inj w/in 8-10hr;tx w/antihistamines;				Y					Y	10/12/1995	10/12/1995	0		PVT	UNK				~ ()~~~In patient	CO6198	1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~5F61097~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098902	04/18/1997	CA				U	02/05/1997	urticarial rash;looked like hives, at site of inj;				Y					Y	10/12/1995	10/12/1995	0		PVT	UNK				~ ()~~~In patient	CO6199	1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~5F61097~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098903	04/18/1997	CA				U	02/05/1997	urticarial rash @ site;tx w/DPH;									Y	10/12/1995	10/12/1995	0		PVT	UNK				~ ()~~~In patient	CO6200	1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~5F61097~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098904	04/18/1997	TX	50.0			F	02/05/1997	16cm blue-black area @ site of inj;had immed tingling @ site;now feeling very tired;				Y					U	10/10/1995	10/12/1995	2		PVT	OTH	80mg daily for ASHD			~ ()~~~In patient	CO6203	1						1	Asthenia; Ecchymosis; Injection site hypersensitivity; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098905	04/18/1997	MA	60.0			F	02/05/1997	redness, swelling & soreness @ site w/in 5hr of vax;									U	10/16/1995	10/16/1995	0		OTH	OTH				~ ()~~~In patient	CO6205	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~5F61117~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098906	04/18/1997	MA	43.0			F	02/05/1997	soreness, redness & swelling @ the site w/in 5hr;									U	10/16/1995	10/16/1995	0		OTH	OTH				~ ()~~~In patient	CO6206	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~5F61117~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0097013	04/21/1997	NY	38.0	38		M	02/14/1997	pt devel back pain p/vax;exp paresthesias, described as band-like feeling around the abd, arms, & legs as well as flip-flop sensation in feet & puffiness in hands;nerve damage;muscle atrophy;encephalomyelitis;myositis;polyneuropathy synd;				Y				Y	N	10/23/1996	10/23/1996	0	EMG/Nerve conduction lower extremities: reportedly abn;CPK: reportedly elevated;CSF: reportedly contained protein;	PVT	OTH	NONE	NONE		~ ()~~~In patient	897072001L	1						1	Back pain; CSF test abnormal; Encephalitis; Infection; Muscle atrophy; Myositis; Neuropathy; Paraesthesia	FLU3~PFIZER\WYETH~~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0097087	04/22/1997	NY	63.0	63		F	04/17/1997	pt recv vax 17OCT96 & exp gen muscle weakness & fever of 102;pt had gen muscle weakness & macular facial rash;7JAN97 pt was adm to hosp because of poor swallowing & aspiration;started on med;					Y				U	10/17/1996	10/18/1996	1	labs CPM 2202, SGOT 90, sed rate 20, RF negative, ARA + 1:2560;	PUB	PVT	NONE			~ ()~~~In patient	CO7070	1						1	Aspartate aminotransferase increased; Dysphagia; Laboratory test abnormal; Lung disorder; Myasthenic syndrome; Pyrexia; Rash maculo-papular; Respiratory disorder	FLU3~CONNAUGHT LABORATORIES~6F71308~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0090419	04/28/1997	CA	64.0	64		M	02/02/1996	pt recv vax 28DEC95 & devel lt arm swelling w/radiating pain into the forearm & redness @ the inj site (lt arm);was advised to use ice 3x daily;this is 1 of 2 pt to report ADE from this site;									Y	12/28/1995	12/29/1995	1		PUB	OTH	NONE	hematuria, tarry stool	prostatism;	~ ()~~~In patient	896051003L	1						2	Injection site hypersensitivity; Oedema peripheral; Pain	FLU3~PFIZER\WYETH~4658083~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~428493~UNK~IM~LA~PNEUMO (PNU-IMUNE)~2|TTOX~LEDERLE LABORATORIES~430111~UNK~IM~LA~TETANUS TOXOID, ADSORBED (NO BRAND NAME)~2	USA		Influenza
0097280	04/29/1997	UT	75.0	75		M		pt described an egg-size swelling w/in hr of vax;felt heat @ site, but no redness;cont for several months;then egg-sized swelling has persisted;aches mildly almost all the time, pain radiates down lt arm to forearm;can't sleep on lt arm;										11/08/1996	11/08/1996	0		PUB	UNK			radical prostatectomy 11/90 d/t prostate cancer	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Insomnia; Oedema peripheral; Pain; Skin nodule	FLU3~PFIZER\WYETH~4968161~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0097284	04/29/1997	CA	56.0	56		F	04/24/1997	pain immed upon recv vax in lt arm;pain got sl worse w/each day;eventually consulted personal MD;provided pain med which helped some;painful to raise;lt hand got numb;pain in neck & back lt side;									N	10/07/1996	10/07/1996	0	med exam x-rays, orthopedic exam, neuro & physical therpay;	OTH	PVT	Prozac, hormone therapy, prilisec, vitamins	NONE	sulfa, keflex, erath	~ ()~~~In patient		1						1	Back pain; Hypokinesia; Injection site pain; Neck pain; Pain; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0097702	05/09/1997	MD	67.0	67		F	04/25/1997	allerg rxn w/swelling of hands, itching of skin & hives;pt had flu shot on 11OCT96 7 devel sx by the next day;pt also completed a wk course of med;also had joint inflammation of many joints;									Y	10/11/1996	10/12/1996	1	NONE	OTH	OTH	ASA;Vitamin E, calcium carbonate, ?, orthosis, provera;	no significant acute illness	diabetes;	~ ()~~~In patient	MD97003	1						1	Arthritis; Hypersensitivity; Oedema peripheral; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71266~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0097690	05/12/1997	UT	44.0	44		M	05/08/1997	RLE cellulitis devel 25JAN97;pt was adm to hosp through the ER;cellulitis resolved w/ATB therapy;				Y	Y	6			Y	10/31/1996	01/25/1997	86	DUT excluding LE dopler;	PVT	PUB	Procardia;Trazadone;	NONE	NKDA	NONE~ ()~~~In patient		1						1	Cellulitis	FLU3~CONNAUGHT LABORATORIES~6F71289~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0097873	05/12/1997	NV	18.0	18		M	04/30/1997	c/o diff breathing, feeling hot, hear racing, skin itching;pt to hosp w/diff breathing & inc skin rxn;hives, erythematous urticarial plaques;pharyngeal edema;periorbital edema;dx anaphylaxis to immun;				Y					Y	04/23/1997	04/23/1997	0	VS POx RA-999-100%; BP 130/90, HR 106, R28;cardiac monitor-sinus tach 110-115 bpm;RR w/M;02 started;EKG NSR, 98 bpm;	MIL	MIL	PPD by Parke Davis lot# 02156P given 23APR97;	NONE	asthma	unk~ ()~~~In patient		1						1	Anaphylactoid reaction; Dyspnoea; Face oedema; Hypertension; Hyperventilation; Pharyngitis; Tachycardia; Urticaria	FLU3~CONNAUGHT LABORATORIES~6J71317~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0990D~1~~RA~HEP B (RECOMBIVAX HB)~1|MEN~CONNAUGHT LABORATORIES~6H81300~1~~LA~MENINGOCOCCAL (MENOMUNE)~1	USA	Emergency room visit	Influenza
0097986	05/14/1997	PA	78.0			M		tingling of legs;								Y			06/18/1996			UNK	UNK	Inderal, Trutal, Muro, prednic, Betagan, APAP			~ ()~~~In patient		1						1	Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0097993	05/14/1997		69.0			M	01/01/1997	n/v, dry heaves;											10/01/1996			UNK	UNK				~ ()~~~In patient		1						1	Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0098040	05/15/1997	GA	31.0	31		F	05/13/1997	approx 45-60 min p/vax throat started to feel tight;pt waited to say anything thinking it would get better;1 of MD looked @ neck & throat & listened to voice & sent to ER;med given. A 31-year-old female was vaccinated with FLU-FLUZONE given '96-'97 (type not specified) on 31-Oct-1996. One hour after the dose it was reported that she developed difficulty breathing, red eyes, swelling of the face, neck and throat and anaphylaxis. There was no history of egg allery or any allergies reported. She is now off PREDNISONE as of today (5-Dec-1996) and her throat has remained swollen until today (5-Dec-1996). The patients local physician feels her vocal chords have been effected. From follow-up information on 29-July-1999, additional patient and vaccine information was provided.				Y					N	10/31/1996	10/31/1996	0	pulmonary flow loop/thyroid levels;	PVT	UNK		NONE	raw onions, keflex, tetracycline, vicodin		7036	1						1	Anaphylactic reaction; Dyspnoea; Immediate post-injection reaction; Local swelling; Ocular hyperaemia; Pharyngeal oedema; Pulmonary function test; Swelling face; Throat tightness; Thyroid function test	FLU3~CONNAUGHT LABORATORIES~6F71320~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0098042	05/16/1997	SC	67.0	67		F	03/10/1997	neuro sx 2mo p/vax;fainting, tingling in hands & feet which progressed to losing function in legs & inability to write or use computer keyboard;couldn't rise to standing position, could move arms but couldn't use hands;dx GBS;numbness;rash				Y	Y	6			Y	11/07/1996	01/13/1997	67	upper extremity reflexes are 1+ and symmetric absent lower extremities;	PUB	PUB	Lopressor;Zestril		takes allergy shots	~ ()~~~In patient	SC97012	1						1	Guillain-Barre syndrome; Hypokinesia; Hyporeflexia; Neuropathy; Paraesthesia; Syncope	FLU3~PARKE-DAVIS~00986P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0095575	05/20/1997	PA	95.0	95		F	02/26/1997	pt recv vax 22OCT96 & 1FEB97 pt was afeb w/nasal congestion & loose cough;tx w/flumadine 3FEB97 for 21 days;pt recovered;this is 1 of 28 cases reported by RN;				Y					Y	10/22/1996	02/01/1997	102	NONE	OTH	OTH	UNK	UNK	myocardial infarction, aortic sclerosis, UTI, congestive heart failure;	~ ()~~~In patient	010150970112000	1						2	Cough; Rhinitis; Cough; Rhinitis	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0099472	05/20/1997	NJ				U	12/11/1996	pt recv vax 1NOV96 & pt devel vomit & diarrhea w/o fever 48hr p/inj;this is one of 25 cases reported by a pharmacist;									U	11/01/1996			UNK	OTH	OTH	UNK	UNK	25OCT96 diarrhea	~ ()~~~In patient	010150960134000	1						1	Diarrhoea; Vomiting	FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0098203	05/21/1997	NY	64.0	63		F	10/23/1996	c/o rash, red, raised, burning on arms, legs & trunk started 48hr p/flu vax;dx systemic urticaria w/pruritis, no resp compromise;rx DPH, calamine lotion, corticosteroid cream;									Y	10/15/1996	10/17/1996	2	NONE	OTH	OTH	Duravert, Ibuprofen, Metamueil	NONE	Diverticulitis;allerg rhinitis;	~ ()~~~In patient		1						1	Pruritus; Rash maculo-papular; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0098209	05/21/1997	WA	51.0	51		F	11/21/1996	approx 2wk p/vax pt c/o sharp pains in area of vax;concerned about long term neuro effects;no prev hx of these type sx;									Y	11/06/1996	11/19/1996	13		PUB	UNK		NONE	NONE	NA~ ()~~~In patient	WA961308	1						1	Injection site pain	FLU3~CONNAUGHT LABORATORIES~6F71289~3~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098238	05/22/1997	WA	70.0	70		F	05/13/1997	pt reports bilat leg pain, weakness, swelling from knees down starting day p/vax given reaching peak 2wk later, gradually improving over next 2-3mo;									N	10/09/1996	10/10/1996	1	NONE	PVT	PVT	Propranolol	NONE	mitral prolapse w/ectopy;lt paresis post childhood polio;scoliosis;	pt exp mild rxn p/prev flu vax in 94 & 93;~ ()~~~In patient		1						1	Myasthenic syndrome; Oedema peripheral; Pain	FLU3~CONNAUGHT LABORATORIES~6F71309~3~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0098979	05/22/1997	MN	73.0	73		F	10/15/1996	1 day p/vax pt devel redness @ the site of vax;1wk following vax inj site was hard & blister was forming;									U	10/07/1996	10/08/1996	1		PVT	OTH	unk	unk		~ ()~~~In patient	896318024L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PARKE-DAVIS~~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~PFIZER\WYETH~4968032~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0099654	05/24/1997	NJ	52.0	52		F	01/22/1997	pt recv vax DEC96 & since then has been exp an allergy rxn manifested by sneezing, watery eyes, itchy nose & mild cough to clear throat;pt has not yet recovered;									N	12/01/1996	12/01/1996	0	UNK	PUB	OTH	NONE	UNK	arteriovenous malformation	~ ()~~~In patient	010150970060000	1						1	Conjunctivitis; Cough; Hypersensitivity; Pruritus; Rhinitis	FLU3~PARKE-DAVIS~01386P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099057	05/27/1997	GA	21.0	21		F	12/05/1996	pt thought they noticed hearing degredation;MD examined & found bilat fluid w/gray membanes;tx w/decongestants;person is impaired since birth & wears 2 aides;				Y					U	12/04/1995	12/10/1995	6		UNK	UNK		NONE	significant hearing impairement since birth;wears 2 hearing adies;	~ ()~~~In patient	CO6406	1						1	Condition aggravated; Otitis media	FLU3~CONNAUGHT LABORATORIES~5F61165~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1016B~UNK~~~HEP B (RECOMBIVAX HB)~1|HEPA~SMITHKLINE BEECHAM~~UNK~~~HEP A (HAVRIX)~1|JEV~CONNAUGHT LABORATORIES~EJN1094~1~~~JAPANESE ENCEPHALITIS (J-VAX)~1	USA	Emergency room visit	Influenza
0098352	05/28/1997	MN	58.0	58		M	05/15/1997	Got Guillain-Barre synd; 5-7 days pvax stomach flu; numb in boxer short area, then wst to toes, then upper body.  Intens care 14d, on respirator; still problems-- eyes yes don't close, tape eyes to sleep, mouth tired when eating; tiredness				Y	Y	24		Y	N	11/12/1996	11/19/1996	7	spinal tap & EMG;	PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Facial palsy; Guillain-Barre syndrome; Influenza; Myasthenic syndrome; Ophthalmoplegia; Paraesthesia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0094653	05/29/1997	PA	41.0	41		M	02/14/1997	pt recv vax 9OCT96 & 29OCT96 pt devel GBS & was hosp 11 days;pt had a relapse & was treated w/IV fluids & plasmapheresis;On an unk date pt had elevated protein in spinal fluid;pt has recovered;					Y	11			Y	10/09/1996	10/29/1996	20	elevated protein in spinal fluid	PVT	PVT	NONE	unk	NONE	~ ()~~~In patient	0101509700920	1						2	Face oedema; Guillain-Barre syndrome; Neuropathy; Paraesthesia; CSF test abnormal; Guillain-Barre syndrome	FLU3~PARKE-DAVIS~~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00276P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Hospitalisation	Influenza
0095568	05/29/1997	PA	88.0	88		F	02/26/1997	pt recv vax 22OCT96 & 1FEB97 pt exp t100, malaise & a loose cough;4FEB97 resp viral cult was positive for influenza A;tx w/flumadine on 3FEB97 for 21 days;pt recovered;this is 1  of 28 cases;				Y					Y	10/22/1996	02/01/1997	102	4FEB97 resp viral cult positive for influenza A;	OTH	OTH	UNK	UNK	hx of duodenal ulcer, degenerative back disease, degenerative joint disease, arteriosclerotic cardiovascular disease;	~ ()~~~In patient	010150970093000	1						2	Cough; Drug ineffective; Infection; Malaise; Pyrexia; Cough; Drug ineffective; Infection; Malaise; Pyrexia	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0095569	05/29/1997	PA	85.0	85		F	02/20/1997	pt recv vax 21OCT96 & 3FEB97 pt exp inc temp & a moist cough;6FEB97 resp viral cult was positive for influenza A:tx included flumadine on 3FEB97 for an unk # of days;this is 1 of 28 cases reported;									Y	10/21/1996	02/03/1997	105	6FEB97 resp viral cult positive for influenza A	OTH	OTH	UNK	UNK	hx of HTN, glaucoma;	~ ()~~~In patient	010150970118000	1						2	Cough; Drug ineffective; Infection; Pyrexia; Cough; Drug ineffective; Infection; Pyrexia	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095570	05/29/1997	PA	79.0	79		F	02/26/1997	pt recv vax 23OCT96 & 28JAN97 exp a fever, coughing & vomiting;tx w/amoxicillin & flumadine on 4FEB97 for 2wk on 15FEB97 for 1wk;pt recovered;this is 1 of 28 cases reported by RN;									Y	10/23/1996	01/28/1997	97	unk	OTH	OTH	unk	unk	hx of HTN, cerebrovascular accident;	~ ()~~~In patient	010150970117000	1						2	Cough; Pyrexia; Vomiting; Cough; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~00296P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095571	05/29/1997	PA	94.0	94		F	02/26/1997	pt recv vax 23OCT96 & 30JAN97 pt exp coughing & a fever;tx included entex on 30JAN97 for 7 days & flumadine on 4FEB97 x 7 days;11FEB97 pt revaccinated w/flu vax;pt recovered;this is 1 of 28 cases reported by RN;									Y	10/23/1996	01/30/1997	99	NONE	OTH	OTH	UNK	UNK	hx of chronic obstructive pulmonary disease, osteoarthritis;	~ ()~~~In patient	010150970116000	1						2	Condition aggravated; Cough; Pyrexia; Cough; Pyrexia	FLU3~PARKE-DAVIS~00296P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095572	05/29/1997	PA	93.0	93		F	02/26/1997	pt recv vax 23OCT96 & 29JAN97 exp fever, cough & inc lethargy described as unable to feed;30JAN97 a resp viral cult was positive for influenza A;tx included Ceclor x 10 days & flumadine 4FEB97 for 2wk & was reordered on 18FEB97 for 1wk;									Y	10/23/1996	01/29/1997	98	30JAN97 resp viral cult positive for influenza A;	OTH	OTH	UNK	UNK	dementia, HTN	~ ()~~~In patient	010150970115000	1						2	Anorexia; Cough; Drug ineffective; Infection; Pyrexia; Somnolence; Anorexia; Cough; Drug ineffective; Infection; Pyrexia; Somnolence	FLU3~PARKE-DAVIS~00296P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095573	05/29/1997	PA	84.0	84		F	02/26/1997	pt recv vax 23OCT96 & 30JAN97 pt exp coughing;tx w/Biaxin on 30JAN97 for 7 days & flumadine on 4FEB97 for 2wk & was reordered on 18FEB97 for 1 wk;pt recovered;this is 1 of 28 cases reported by RN;									Y	10/23/1996	01/30/1997	99	NONE	OTH	OTH	UNK	UNK	hx of parkinson's disease, coronary artery disease;	~ ()~~~In patient	010150970114000	1						2	Cough; Cough	FLU3~PARKE-DAVIS~00296P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095574	05/29/1997	PA	82.0	82		M	02/26/1997	pt recv vax 28OCT96 & on 4FEB97 pt was afeb & exp a moist, non-productive cough;tx w/flumadine 3FEB97 for 21 days;pt recovered;this is 1 of 28 cases reported by RN;				Y					Y	10/28/1996	02/04/1997	99	NONE	OTH	OTH	UNK	UNK	hx of congestive heart failure, cardiac risk factors, ischemic cardiomyopathy, polymyalgia rheumatica;	~ ()~~~In patient	010150970113000	1						2	Cough; Cough	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0095576	05/29/1997	PA	81.0	81		F	02/26/1997	pt recv vax 23OCT96 & 30JAN97 exp a temp 100, cough & chest congestion;tx included Flumadine 4FEB97 for 21 days;pt recovered;this is 1 of 28 cases reported to RN;				Y					Y	10/23/1996	01/30/1997	99	NONE	OTH	OTH	UNK	UNK	glaucoma, HTN, status post cerebrovascular accident	~ ()~~~In patient	010150970111000	1						2	Cough; Lung disorder; Pyrexia; Cough; Lung disorder; Pyrexia	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0095578	05/29/1997	PA	92.0	91		F	02/26/1997	pt recv vax 23OCT96 & 1FEB97 exp t100 & a productive cough;tx w/flumadine 4FEB97 for 21 days;pt recovered;this is 1 of 28 cases reported by RN;				Y					Y	10/23/1996	02/01/1997	101	NONE	OTH	OTH	UNk	UNK	hx atrial fibrillation, mitral valve regurgitation, NIDDM, adjustment disorder;	~ ()~~~In patient	010150970109000	1						2	Cough; Pyrexia; Cough; Pyrexia	FLU3~PARKE-DAVIS~00296P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0095579	05/29/1997	PA	94.0	94		F	02/26/1997	pt recv vax 21OCT96 & 1FEB97 pt was afeb w/a loose cough;tx w/flumadine 3FEB97 for 21 days;pt recovered;this is 1 of 28 cases;				Y					Y	10/21/1996	02/01/1997	103	NONE	OTH	OTH	UNK	UNK	chronic atrial fibrillation, HTN, chronic obstructive pulmonary disease, chronic fenal failure;	~ ()~~~In patient	010150970108000	1						2	Cough; Cough	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0095580	05/29/1997	PA	81.0	81		F	02/26/1997	pt recv vax 23OCT96 & 1FEB97 pt exp an inc temp, a moist, non productive cough & post nasal drip;tx w/Robitussin & flumadine which was ordered on 3FEB97;this is 1 of 29 cases reported;									Y	10/23/1996	02/01/1997	101	NONE	OTH	OTH	UNK	UNK	hx HTN,Hypothroid, depression, dementia, arthritis	~ ()~~~In patient	010150970107000	1						2	Cough; Pyrexia; Rhinitis; Cough; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095581	05/29/1997	PA	81.0	80		F	02/26/1997	pt recv vax 22OCT96 & 31JAN97 pt exp cold sx;4FEB97 a resp viral cult was positive for influenza A;tx w/Robitussin & flumadine for 2wk;flumadine was reordered;this is 1 of 28 cases reported by Rn;									Y	10/22/1996	01/31/1997	101	4FEB97 resp viral cult-positive for influenza A;	OTH	OTH	UNk	UNK	bowel obstruction, status post bilat mastectomies, arthritis;	~ ()~~~In patient	010150970106000	1						2	Cough decreased; Drug ineffective; Infection; Pyrexia; Rhinitis; Drug ineffective; Infection; Pharyngitis; Rhinitis	FLU3~PARKE-DAVIS~00296P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095583	05/29/1997	PA	72.0	72		F	02/26/1997	pt recv vax 21OCT96 & 29JAn97 pt exp nasal congestion;tx included actifed, Robitussin & flumadine 3FEB97 for 2wk & was reordered 18FEB97 for 7 days;pt recovered;this is 1 of 28 cases;									Y	10/21/1996	01/29/1997	100	NONE	OTH	OTH	UNK	UNK	hx bilat cellulitis, NIDDM,Obesity, HTN, anemia;	~ ()~~~In patient	010150970104000	1						2	Pyrexia; Rhinitis; Rhinitis	FLU3~PARKE-DAVIS~00296P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095584	05/29/1997	PA	91.0	91		F	02/26/1997	pt recv vax 22OCT96 & 3FEB97 exp inc temp of 101, chest congestion (wheezing)  & a non-productive cough;4FEB97 a throat cult was positive for influenza A:tx w/Zithromax, Robitussin & Flumadine for 2wk;7FEB97 pt recv vax, flumadine reordered									Y	10/22/1996	02/03/1997	104	4FEB97 throat cult-positive for influenza A	OTH	OTH	UNK	UNK	hx of dementia, osteoarthritis	~ ()~~~In patient	010150970103000	1						2	Asthma; Cough; Drug ineffective; Infection; Lung disorder; Pyrexia; Asthma; Cough; Drug ineffective; Infection; Lung disorder; Pyrexia	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095586	05/29/1997	PA	72.0	72		M	02/26/1997	pt recv vax 22OCT96 & 11FEB97 pt exp an occasional loose cough, an inc temp of 99 7 was lethargic;12FEB97 had a temp of 100 & a cough;13FEB97 had a temp of 102.5;12FEB97 a cult positive for influenza A;tx included biaxin & flumadine;									Y	10/22/1996	02/11/1997	112	12FEB97 cult positive for influenza A	OTH	OTH	UNK	UNK	hx Parkinson's Disease, Dementia, Diabetes;	~ ()~~~In patient	010150970102000	1						2	Cough; Drug ineffective; Infection; Pyrexia; Somnolence; Cough; Drug ineffective; Infection; Pyrexia; Somnolence	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095587	05/29/1997	PA	92.0	91		F	02/26/1997	pt recv vax 23OCT96 & 29JAN97 pt exp productive cough, an inc temp of 100 & nasal congestion;tx included flumadine on 4FEB97 for 21 days;pt recovered;this is 1 of 28 cases reported by RN;				Y					Y	10/23/1996	01/29/1997	98	NONE	OTH	OTH	UNK	UNK	hx of ateriosclerotic heart disease, degenerative disc disease, osteoporosis, degenterative joint disease;	~ ()~~~In patient	010150970101000	1						2	Cough; Pyrexia; Rhinitis; Cough decreased; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~00296P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0095588	05/29/1997	PA	90.0	90		M	02/26/1997	pt recv vax 23OCT96 & 29JAN97 exp productive cough & an inc temp of 100;tx included flumadine on 4FEB97 for 21 days;pt recovered;this is 1 of 28 cases reported by RN;				Y					Y	10/23/1996	01/26/1997	95	NONE	OTH	OTH	UNK	UNK	hx arteriosclerotic heart disease, degenrative joint disease, COPD, irritable bowel synd;	~ ()~~~In patient	010150970100000	1						2	Cough; Pyrexia; Cough; Pyrexia	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0095589	05/29/1997	PA	85.0	84		F	02/26/1997	pt recv vax 17OCT96 & 29JAN97 pt afeb & exp productive cough;30JAN97 a resp viral cult was positive for influenza A:tx included flumadine on 4FEB97 for 21 days;pt recovered;this is 1 of 28 cases reported by RN;				Y					Y	10/17/1996	01/29/1997	104	30JAN97 resp viral cult positive for influenza A	OTH	OTH	UNK	UNK	chronic asthma, asthenic personality, cerebrovascular ischemic disease, anxiety;	~ ()~~~In patient	010150970099000	1						2	Cough; Drug ineffective; Infection; Cough; Drug ineffective; Infection	FLU3~PARKE-DAVIS~00296P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0095590	05/29/1997	PA	94.0	94		F	02/24/1997	pt recv vax 21OCT96 & 3FEB97 pt exp inc temp & cough;6FEB97 a resp viral cult was positive for influenza A;tx included Flumadine on 12FEB97;pt recovered;this is 1 of 28 cases reported by RN;									Y	10/21/1996	02/03/1997	105	6FEB97 resp viral cult positive for influenza A;	OTH	OTH	UNK	UNK	hx alzheimer's disease, pressure ulcer on rt toe;	~ ()~~~In patient	010150970098000	1						2	Cough; Drug ineffective; Infection; Pyrexia; Cough; Drug ineffective; Infection; Pyrexia	FLU3~PARKE-DAVIS~00296D~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095591	05/29/1997	PA	82.0	81		F	02/24/1997	pt recv vax 21OCT96 & 2FEB97 pt exp an inc temp & a cough;7FEB97 resp viral cult was positive for influenza A;pt recovered;this is 1 of 28 cases reported by RN;									Y	10/21/1996	02/20/1997	122	7FEB97 resp viral cult positive for influenza A	OTH	OTH	UNK	UNK	hx of non-communicating hydrocephalus, sinsu tachycardia, osteoporosis;	~ ()~~~In patient	010150970097000	1						2	Cough; Drug ineffective; Headache; Infection; Pyrexia; Cough; Drug ineffective; Infection; Pyrexia	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0095593	05/29/1997	PA	89.0	89		F	02/26/1997	pt recv vax 21OCT96 & 3FEB97 pt exp a t100.6 & wheezing;rales were heard bilat;resp viral cult came back positive for the influenza A virus;pt recv flumadine;									N	10/21/1996	02/03/1997	105	RVC showed positive influenza A;	PUB	OTH	UNK	UNK	COPD, CAD, CHF, ASCVD	~ ()~~~In patient	010150970096000	1						2	Asthma; Drug ineffective; Infection; Lung disorder; Pyrexia; Asthma; Drug ineffective; Infection; Lung disorder; Pyrexia	FLU3~PARKE-DAVIS~00296P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0098481	05/29/1997	PA	55.0			M	04/29/1997	pt recv vax & on 18NOV96 pt adm to hosp w/numbness of toes, feet, ankles, hands diff swallowing;dx w/GBS;d/c & has not yet recovered;EMG consistent w/acute demyelination & LP which revealed protein 148, glucose 75, WBC 1 & RBC 9;					Y	10			U		11/18/1996		EMG consistent w/acute demyelination;LP protein 148, glucose 75, WBC 1, RBC 9;	OTH	OTH	NONE	unk	GBS following prior vax;	~ ()~~~In patient	1015097006700	1						1	CSF test abnormal; Dysphagia; Guillain-Barre syndrome; Neuropathy; Paraesthesia	FLU3~PARKE-DAVIS~00476P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0099381	05/29/1997	IL	38.0			M	11/21/1996	pt recv vax 8OCT96 & on 9OCT96 w/in 12hr of vax pt devel gen hives &  pruritus & a tightness in chest;tx w/DPH;chest tightness resolved & the hives & pruritus cont;				Y					Y	10/08/1996	10/08/1996	0	NONE	OTH	OTH	allergy shots	unk	hx of hayfever;allergy to IVP dye;	~ ()~~~In patient	010150960032000	1						1	Chest pain; Pruritus; Urticaria	FLU3~PARKE-DAVIS~00786P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099382	05/29/1997	MA				U	11/11/1996	pt recv vax OCT96 & devel unspecified cold sxs & t101;pt recovered;									Y	10/01/1996	10/01/1996	0	unk	PVT	OTH	unk	unk	unk	~ ()~~~In patient	010150960084000	1						1	Pharyngitis; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~00596P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099383	05/29/1997	NY	30.0			F	11/19/1996	pt recv vax 10OCT96 & 11OCT96 12hr p/vax pt exp lt arm swelling;swelling to lt body including lt leg & lt breast;18OCT96 had an asthma attack;19OCT96 face swelled & broke out in rash;lips swelled, couldn't eat x 2d;itching;pain arm;				Y					Y	10/10/1996	10/11/1996	1	15OCT96 EMG negative;	PVT	OTH	Theo-dur, Azmacort, Nebulizer treatments;	unk	hx of asthma/allergy to OJ & tomatoes;NKA not allergic to  eggs;never had flu shot;	~ ()~~~In patient	010150960129000	1						1	Anorexia; Asthma; Condition aggravated; Face oedema; Neuralgia; Oedema peripheral; Pain; Rash	FLU3~PARKE-DAVIS~00986P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099384	05/29/1997	TX	65.0	65		M	01/23/1997	pt recv vax 22OCT96 & 4DEC96 pt started having SOB & a productive cough;2wk later pt devel chills & fever;pt saw MD 3x;				Y					N	10/22/1996	12/04/1996	43	NONE	PVT	PVT	Prednisone, Bronchial dilators	unk	chronic obstructive pulmonary disease;	~ ()~~~In patient	010150970079000	1						1	Chills; Cough; Dyspnoea; Pyrexia	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099385	05/29/1997	MO	51.0	50		M	04/26/1996	pt recv vax 19OCT95 & w/in 24hr p/inj rt arm became red, warm,  swollen, & painful;also exp stiffness in rt hand fingers, weakness & joint pain in rt arm;pt has recovered;				Y					Y	10/19/1995	10/20/1995	1	NONE	PVT	OTH	Paxil, Vanceril MDI, ventolin		asthma, actinic keratosis;	~ ()~~~In patient	010150960016000	1						1	Arthralgia; Arthropathy; Asthenia; Hypertonia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PARKE-DAVIS~~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0099386	05/29/1997	OK	78.0	78		F	06/18/1996	pt recv vax 7NOV95 & on 9NOV95 2PM pt devel sl swelling & redness @ inj site;pt had no c/o SOB;pt recovered;									Y	11/07/1995	11/09/1995	2	NONE	PVT	PVT	unk		chronic obstructive pulmonary disease;arthritis;	~ ()~~~In patient	010150960017000	1						1	Injection site hypersensitivity; Injection site oedema; Injection site hypersensitivity; Injection site oedema	FLU3~PARKE-DAVIS~00675P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~394934~1~~RA~PNEUMO (PNEUMOVAX)~1|FLU3~PARKE-DAVIS~00675~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0099387	05/29/1997	TX	24.0	24		F	09/30/1996	pt recv vax 9SEP96 & 10SEP96 exp an inj site rxn manifested by a raised circle (circumference=1inch) around the inj site w/fever & extreme soreness in arm;pt recovered;									Y	09/09/1996	09/10/1996	1	NONE	OTH	OTH	NONE	unk	NONE	~ ()~~~In patient	010150960019000	1						1	Injection site mass; Injection site pain; Pyrexia	FLU3~PARKE-DAVIS~01066P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099388	05/29/1997	TX	56.0	56		F	09/27/1996	pt recv vax 9SEP96 & 11SEP96 pt devel an inj site rxn;lt arm was sorer than usual & a knot devel under the lt armpit w/swelling which extended to the outside of the lt breast which was very tender;									Y	09/09/1996	09/11/1996	2	NONE	OTH	OTH	Glucophage, Vitamin E, Vitamin B comples, calan Sr, Hytrin, hydrochlorothiazide, multivitamins, Zoloft, Elavil, ASA;	unk	hx of HTN, diabetes;	~ ()~~~In patient	010150960020000	1						1	Injection site reaction; Lymphadenopathy; Myalgia; Oedema; Pain	FLU3~PARKE-DAVIS~01066P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099389	05/29/1997	TX	42.0	42		F	10/01/1996	patient 1 of 6: pt recv vax & 6hr p/vax pt devel nausea & chills which cont most of the day;pt recovered;									Y	09/09/1996	09/09/1996	0	NONE	OTH	OTH	NONE	unk	NONE	~ ()~~~In patient	010150960021000	1						1	Chills; Nausea	FLU3~PARKE-DAVIS~01066P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099390	05/29/1997	TX	22.0	22		F	10/02/1996	pt recv vax 9SEP96 & 10SEP96 the inj site was hot (feverish) & was sore for 3 days;pt had no hx of rxn w/flu vax;									Y	09/09/1996	09/10/1996	1	NONE	OTH	OTH	Birth control pill	unk	hx of asthma	~ ()~~~In patient	010150960023000	1						1	Myalgia; Vasodilatation	FLU3~PARKE-DAVIS~01066P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099391	05/29/1997	TX	49.0	49		F	10/03/1996	pt recv vax 9SEP96 & inj site area became very red & feverish the same day;rxn lasted about 2 days;pt recovered;									Y	09/09/1996	09/09/1996	0	NONE	OTH	OTH	NONE	unk	No prior hx of rxn to flu vax;	~ ()~~~In patient	010150960024000	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PARKE-DAVIS~01066P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099392	05/29/1997	IL	44.0			M	10/29/1996	pt recv vax 2OCT96 & evening of same day devel a gen rash that started on lower extremities & extended to trunk & upper extremities;rash covered most of body except face, txd w/pred pack, rash cleared				Y					Y	10/02/1996	10/02/1996	0	NONE	OTH	OTH	Claritin	unk	allergy to rag weed & PCN;	~ ()~~~In patient	010150960025000	1						1	Rash	FLU3~PARKE-DAVIS~00576P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099393	05/29/1997	PA	39.0			F	10/11/1996	pt recv vax & exp itching & flushing of upper head, neck, face, arms & eyebrows 10 min p/vax;7OCT96 pt treated w/DPH;pt also broke out in red blotches that itched & had numbness of the lip & tightness in throat;sx resolved w/in 1hr;									Y	10/01/1996	10/07/1996	6	NONE	PVT	OTH	NONE	unk	hx of multiple med & other allergies;allergy to hep B vax;asthma;	~ ()~~~In patient	010150960027000	1						1	Laryngospasm; Paraesthesia oral; Pruritus; Rash maculo-papular; Vasodilatation	FLU3~PARKE-DAVIS~01286P~1~SC A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099394	05/29/1997	PA	50.0			F	10/11/1996	pt recv vax 8OCT96 & 30min p/vax pt exp itching & flushing of upper head, neck & face, red blotches on arms & legs, a small red rash around the eyes;tx w/DPH;pt did not have SOB;									Y	10/08/1996	10/08/1996	0	NONE	PVT	OTH	NONE	unk	hx of multiple allergies to other drugs;	~ ()~~~In patient	010150960028000	1						1	Pruritus; Rash; Rash maculo-papular; Vasodilatation	FLU3~PARKE-DAVIS~01286P~1~SC A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099395	05/29/1997	HI				U	10/14/1996	pt recv vax & exp noc sweats & dizziness;pt has hx of MS;									U				NONE	MIL	MIL	unk	unk	hx of multiple sclerosis	~ ()~~~In patient	010150960029000	1						1	Dizziness; Hyperhidrosis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099396	05/29/1997	NY	64.0	63		F	10/14/1996	pt recv vax 8OCT96 & 9OCT96 pt devel h/a, weakness, wa snot sure footed & was nauseous;pt took pepto-bismol for nausea w/o relief;all sx cont;									N	10/08/1996	10/09/1996	1	NONE	PVT	OTH	Aldactone, Premarin	unk	hx flu sx p/vax in 1991, multiple drug allergies, HTN, Conn's synd & glucose intolerance;	~ ()~~~In patient	010150960030000	1						1	Asthenia; Dizziness; Headache; Nausea	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099397	05/29/1997	MD	52.0	52		F	10/14/1996	pt recv vax 11OCT96 & devel redness, swelling & pain @ inj site;pt has recovered;									Y	10/11/1996	10/11/1996	0	NONE	OTH	OTH	NONE	unk	NONE	~ ()~~~In patient	010150960031000	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKE-DAVIS~~UNK~SC A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099398	05/29/1997	NY	81.0	81		M	10/15/1996	pt recv vax 8OCT96 & 9OCT96 pt devel a h/a, nausea & sleepiness;pt has not yet recovered;									N	10/08/1996	10/09/1996	1	NONE	PVT	OTH	NONE	UNK	NONE	~ ()~~~In patient	010150960033000	1						1	Headache; Nausea; Somnolence	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~UNKNOWN MANUFACTURER~~1~IM A~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0099399	05/29/1997	FL	70.0	70		F	10/21/1996	pt recv vax & devel an inj site rxn (red, warm @ site) in OCT96;									Y	10/14/1996	10/15/1996	1	NONE	PVT	OTH	Ativan, Synthroid	UNK	NONE	~ ()~~~In patient	010150960034000	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099400	05/29/1997	FL	78.0	78		F	11/27/1996	pt recv vax & devel an inj site rxn (red, warm to site) in OCT96 p/vax;									Y	10/10/1996	10/11/1996	1	NONE	PVT	OTH	Synthroid, Nolvadex	unk	Cancer of the breast APR90;	~ ()~~~In patient	010150960036000	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099401	05/29/1997	VA	38.0			F	10/28/1996	pt recv vax 17OCT96 & pt devel knot @ inj site & cellulitis;tx w/DPH & Biaxin;sx resolved & pt has recovered;									Y	10/17/1996	10/17/1996	0	NONE	OTH	OTH	NONE	UNK	NONE	~ ()~~~In patient	010150960038000	1						1	Cellulitis; Injection site mass	FLU3~PARKE-DAVIS~~UNK~SC A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099402	05/29/1997	KY	42.0	42		F	10/23/1996	pt recv vax 11OCT96 & 12OCT96 pt devel a total body itch w/a  red, raised measles-like rash transient but especially on back;tx in ER w/pred burst;DPH & a cortisone inj & obtained no relief;				Y					N	10/11/1996	10/12/1996	1	UA & blood work results unk cult unk were negative;	PVT	OTH	NONE	UNK	No allergies	~ ()~~~In patient	010150960039000	1						1	Pruritus; Rash maculo-papular	FLU3~PARKE-DAVIS~00686P~2~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099403	05/29/1997	VA				U	10/30/1996	pt devel aching, malaise & an inj site rxn (redness) in OCT96 p/vax;no other info available;this case was reported by MD via company representative;									U		10/01/1996		NONE	PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient	010150960040000	1						1	Injection site hypersensitivity; Malaise; Myalgia	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099404	05/29/1997	MA				U	10/30/1996	pt devel a large welt @ the inj site immed p/vax on 30CT96;this was one of three cased reported by a RN;cross reference w/MFR report 0010150960042 & 0010150960043;									U	10/30/1996	10/30/1996	0	UNK	OTH	OTH	unk	unk	unk	~ ()~~~In patient	010150960041000	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~00596P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099405	05/29/1997	MA				U	10/30/1996	pt devel large welt @ inj site immed p/vax on 30OCT96; this was one of three cases reported by a RN;cross reference w/MFR report 0010150960041 & 0010150960043;									U	10/30/1996	10/30/1996	0	UNK	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960042000	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~00596P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099406	05/29/1997	MA				U	10/30/1996	pt devel large welt @ the inj site imed p/vax on 30OCT96;this was one of three cases reported by a RN;cross reference w/MFR report # 010150960041 & 010150960042;									U	10/30/1996	10/30/1996	0	UNK	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960043000	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~00596P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099407	05/29/1997	FL	17.0			F	12/03/1996	pt recv vax 17SEP96 & pt exp severe h/a 30min p/vax;pt seen by MD & a neurologist;ha/ were incapacitating;pt was prescribed Ibuprofen w/o significant relief;pt cont to exp severe h/a now 2w p/vax;pt exp fever, n/v, neck stiffness;flu synd;				Y					Y	09/17/1996	09/17/1996	0	NONE	PVT	OTH	ACNE medication	UNK	asthma, allergy to Macrodantin & family hx of migraines;	~ ()~~~In patient	010150960044000	1						1	Headache; Influenza; Nuchal rigidity; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~00586P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099408	05/29/1997	NY	59.0	59		F	12/30/1996	pt recv vax 17OCT96 & 4hr p/vax pt exp chest pain & a lump in throat;pt taken to ER & given DPH;EKG nl;pt was not hosp;pt has recovered;MD felt was reflux problem;				Y					Y	10/17/1996	10/17/1996	0	EKG was nl	OTH	OTH	Fosamax, Unabid, Pretz, Estrogen	UNK	allergy to vicodin;sinusitis, osteoarthritis, cervical disc problems, benign breast mass, asthma;	~ ()~~~In patient	010150960047000	1						1	Chest pain; Gastrointestinal disorder; Laryngospasm	FLU3~PARKE-DAVIS~00176P~4~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099409	05/29/1997	MD	55.0			F	11/05/1996	pt recv vax OCT96 & devel hives pt was treated w/DPH & recovered;this case was reported by a MD;									Y	10/01/1996	10/01/1996	0	UNK	PVT	OTH	NONE	UNK	hx of allergy to sulfa	~ ()~~~In patient	010150960049000	1						1	Urticaria	FLU3~PARKE-DAVIS~~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099410	05/29/1997	NY				U	11/05/1996	pt recv vax 30SEP96 & devel redness & warmth @ the inj site the same day;outcome is unk;this case was reported by a RN;cross reference w/ 010150960051/54;									U	09/30/1996	09/30/1996	0	UNK	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960050000	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PARKE-DAVIS~409G~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099411	05/29/1997	NY	75.0	75		F	11/07/1996	pt recv vax 4OCT96 & 1wk post inj 11OCT96, 2wk post inj devel focal skin rash;A biopsy of the rash was performed;later devel numbness of both hands;MRI was done 24OCT96;pt did not exp any motor weakness;rash is subsiding;other sx persist;				Y					N	10/04/1996	10/11/1996	7	ANA negative x 1/x1 positive, lyme titer negative, CPK nl; skin biopsy, blood C&S, sed rate, MRI, urine analysis & chem 16 pending;	PVT	OTH	NONE	UNK	NONE	~ ()~~~In patient	010150960055000	1						1	Antinuclear antibody; Arthralgia; Myalgia; Paraesthesia; Rash	FLU3~PARKE-DAVIS~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099412	05/29/1997	WV	49.0	49		F	12/26/1996	pt recv vax & devel weakness, cold sweats, elevated temp alternating w/low grade temp, nausea, heightened sensation of smell & abd soreness on 11OCT96 p/vax 30SEP96;pt went to MD 15OCT96 & was dx w/enlarged liver;				Y					Y	09/30/1996	10/11/1996	11	BANDS 12 (0-5);K+ 3.3 (3.5-5.5);PLT 83 (140-415);18OCT96 LDH 5222;K+ 3.3;WBC 4.58;PLT 139;	PUB	OTH	NONE	UNK	NONE	~ ()~~~In patient	010150960056000	1						1	Abdominal pain; Arthralgia; Asthenia; Hepatomegaly; Hyperhidrosis; Nausea; Parosmia; Pyrexia	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099413	05/29/1997	NJ				U	12/11/1996	pt recv vax 22OCT96 or 23OCT96 & pt devel n/v & diarrhea w/o fever 48hr p/inj;pharmacist  related there were other pt that exp vomiting & diarrhea who did not recv flu vax;this is one of 25 cases reported by pharmacist;									U	10/22/1996	10/25/1996	3	UNK	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960058000	1						1	Diarrhoea; Nausea; Vomiting	FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099414	05/29/1997	NJ				U	12/11/1996	pt recv vax 22OCT96 or 23OCT96;pt devel vomiting & diarrhea w/o fever 48hr p/vax;10NOV96 pt exp n/v & 1 loose bowel movement;									U	10/22/1996	11/10/1996	19	UNK	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960059000	1						1	Diarrhoea; Vomiting	FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099415	05/29/1997	NJ				U	12/11/1996	pt recv vax 22OCT96 & 23OCT96 pt devel vomiting & diarrhea w/o fever 48hr p/vax;Pharmacist related other pt exp v,d who did not recv vax;									U	10/22/1996			UNK	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960060000	1						1	Diarrhoea; Vomiting	FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099416	05/29/1997	NJ				U	12/11/1996	pt recv vax 22OCT96 & 23OCT96 pt devel vomit & diarrhea w/o fever 48hr p/inj;pharmacist related there were other pt that exp v,d who did not recv flu vax;this is one of 25 cases reported by a pharmacist;									U				UNK	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960061000	1						1	Diarrhoea; Vomiting	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099417	05/29/1997	NJ				U	12/11/1996	pt recv vax 22OCT96 or 23OCT96 pt devel vomiting & diarrhea w/o fever p/vax;pharmacist related there were other pt that exp vomit & diarrhea who did not recv vax;									U	11/01/1996	11/05/1996	4	UNK	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960062000	1						1	Diarrhoea; Vomiting	FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099418	05/29/1997	NJ				U	12/11/1996	pt recv vax 22OCT96 & 23OCT96 pt devel vomiting & diarrhea w/o fever 48hr p/vax;pharmacist related there were other pt that exp v,d who did not recv vax;									U	10/23/1996	10/30/1996	7	UNK	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960063000	1						1	Diarrhoea; Vomiting	FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099419	05/29/1997	NJ				U	12/11/1996	pt recv vax 22OCT96 & 23OCT96 pt devel vomiting & diarrhea w/o fever 48hr p/vax;pharmacist related were other pt that exp vomiting & diarrhea who did not recv vax;this is 1 of 25 reports;									U	10/23/1996	10/25/1996	2	UNK	OTH	OTH	unk	unk	unk	~ ()~~~In patient	010150960064000	1						1	Diarrhoea; Vomiting	FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099420	05/29/1997	NJ				U	12/11/1996	pt recv vax 22OCT96 & 23OCT96 pt devel vomit & diarrhea w/o fever 48hr p/vax;pharmacist related there were other pt that exp v,d who did not recv vax; this is 1 of 25 cases reported by a pharmacist;									U	10/23/1996	11/04/1996	12	UNK	OTH	OTH	unk	unk	unk	~ ()~~~In patient	010150960065000	1						1	Diarrhoea; Vomiting	FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099421	05/29/1997	NJ				U	12/11/1996	pt recv vax 22OCT96 & 23OCT96;pt devel vomit, diarrhea w/o fever 48hr p/vax;pharmacist related there were other pt that exp v,d who did not recv vax;this is one of 25 cases reported by a pharmacist;									U	10/23/1996	10/30/1996	7	unk	OTH	OTH	unk	unk	unk	~ ()~~~In patient	010150960066000	1						1	Diarrhoea; Vomiting	FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099422	05/29/1997	NJ				U	12/11/1996	pt recv vax 22OCT96 & 23OCT96;pt devel vomit & diarrhea w/o fever 48hr p/vax;pharmacist related there wee other pt that exp v, d who did not recv vax;this is one of 25 cases reported by a pharmacist;									U	10/24/1996	10/28/1996	4	UNK	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960067000	1						1	Diarrhoea; Vomiting	FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099423	05/29/1997	NJ				U	12/11/1996	pt recv vax 22OCT96 or 23OCT96 pt devel vomiting & diarrhea w/o fever p/inj;pharmacist related there were other pt that exp v,d who did not recv flu vax;this is one of 25 cases reported to a pharmacist;									U	10/23/1996	10/23/1996	0	UNK	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960068000	1						1	Diarrhoea; Vomiting	FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099424	05/29/1997	TX	49.0			F	10/01/1996	pt recv vax & felt lightheaded for a few seconds;pt has an allergy to tetracycline & has no prior hx of rxn to flu vax;pt recovered;									Y				unk	OTH	OTH	Thyroid medication	UNK	allergy to tetracycline	~ ()~~~In patient	010150960022000	1						1	Dizziness	FLU3~PARKE-DAVIS~01066[~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099425	05/29/1997	NJ				U	12/11/1996	pt recv vax 24OCT96 & pt devel vomit & diarrhea w/o fever 48hr p/vax;pharmacist relater there were other pt that exp v,d who did not recv vax;this is one of 25 cases reported by pharmacist;									U	10/24/1996	10/24/1996	0	UNK	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960069000	1						1	Diarrhoea; Vomiting	FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099426	05/29/1997	NJ				U	12/11/1996	pt recv vax 25OCT96 & pt devel vomiting & diarrhea w/o fever 48hr p/vax;pharmacist related there were other pt that exp v,d who did not recv vax;this is one of 25 cases reported by pharmacist;									U	10/25/1996	10/27/1996	2	UNK	OTH	OTH	UNK	UNK	22OCT96-nausea & vomiting;	~ ()~~~In patient	010150960070000	1						1	Diarrhoea; Vomiting	FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099427	05/29/1997	NJ				U	12/11/1996	pt recv vax 1NOV96 & pt devel vomiting & diarrhea w/o fever 48hr p/inj;pharmacist related there were other pt that exp v,d who did not recv vax;this is one of 25 cases reported by a pharmacist;									U	11/01/1996	11/03/1996	2	UNK	OTH	OTH	UNK	UNK	22OCT96 nausea & vomiting;	~ ()~~~In patient	010150960071000	1						1	Diarrhoea; Vomiting	FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099428	05/29/1997	NJ				U	12/11/1996	pt recv vax 1NOV96 & pt devel vomiting & diarrhea w/o fever 48hr p/vax;pharmacist related there were other pt that exp v, d who did not recv vax;this is one of 25 cases reported by a pharmacist;									U	11/01/1996			UNK	OTH	OTH	UNK	UNK	22OCT96 Nausea, Vomiting;	~ ()~~~In patient	010150960072000	1						1	Diarrhoea; Vomiting	FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099429	05/29/1997	NJ				U	12/11/1996	pt recv vax 1NOV96 & pt devel vomit & diarrhea w/o fever 48hr p/vax;pharmacist related there were other pt that exp v,d who did not recv vax;this is one of 225 cases reported by a pharmacist;									U	11/01/1996	11/03/1996	2	UNK	OTH	OTH	UNK	UNK	29OCT96 nausea & vomit	~ ()~~~In patient	010150960073000	1						1	Diarrhoea; Vomiting	FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099430	05/29/1997	NJ				U	12/11/1996	pt recv vax 1NOV96 & pt devel vomiting & diarrhea w/o fever 48hr p/inj;pharmacist related there was other pt that exp v, d who did not recv vax;this is one of 25 cases reported by a pharmacist;									U	11/01/1996	11/03/1996	2	UNK	OTH	OTH	UNK	UNK	25OCT96 Nausea & Vomiting;	~ ()~~~In patient	010150960074000	1						1	Diarrhoea; Vomiting; Diarrhoea; Vomiting	FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0099430	05/29/1997	NJ				U	12/11/1996	pt recv vax 1NOV96 & pt devel vomiting & diarrhea w/o fever 48hr p/vax;pharmacist related there were other pt that exp vomiting & diarrhea who did not recv vax;this is one of 25 cases reported by pharmacist;									U	11/01/1996	11/03/1996	2	UNK	OTH	OTH	UNK	UNK	23OCT96 nausea & vomiting;	~ ()~~~In patient	010150960077000	1						2	Diarrhoea; Vomiting; Diarrhoea; Vomiting	FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0099431	05/29/1997	NJ				U	12/11/1996	pt recv vax 1NOV96 & pt devel vomiting & diarrhea w/o fever 48hr p/vax;pharmacist related there were other pt that exp v,d who did not recv flu vax;this is one of 25 cases reported by pharmacist;									U	11/01/1996			UNK	OTH	OTH	UNK	UNK	23OCT96 nausea & vomiting;	~ ()~~~In patient	010150960075000	1						1	Diarrhoea; Vomiting	FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099432	05/29/1997	NJ				U	12/11/1996	pt recv vax 1NOV96 & pt devel vomiting & diarrhea w/o fever 48hr p/vax;pharmacist related there were other pt that exp v, d who did not recv flu vax;this is one of 25 cases reported by a pharmacist;									U	11/01/1996	11/03/1996	2	UNK	OTH	OTH	UNK	UNK	23OCT96 Nausea & vomiting;	~ ()~~~In patient	010150960076000	1						1	Diarrhoea; Vomiting	FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099434	05/29/1997	MA				U	11/11/1996	pt recv vax in late OCT96 & devel an inj site rxn w/a quarter-sized welt w/redness & induration;pt recovered;this is 1 of 5 pt;									Y	10/01/1996	10/01/1996	0	UNK	PVT	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960078000	1						1	Injection site hypersensitivity; Injection site mass; Injection site reaction; Urticaria	FLU3~PARKE-DAVIS~0059P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099435	05/29/1997	MA				U	11/11/1996	pt recv vax late OCT96 & devel an inj site rxn w/a quarter size welt w/redness & induration pt recovered;this is 1 of 5 pt;									Y	10/01/1996	10/01/1996	0	UNk	PVT	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960079000	1						1	Injection site hypersensitivity; Injection site mass; Injection site reaction; Urticaria	FLU3~PARKE-DAVIS~00596P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099436	05/29/1997	MA				U	11/11/1996	pt recv vax in late OCT96 & devel an inj site rxn w/a quarter-sized welt w/redness & induration;pt recovered;									Y	10/01/1996	10/01/1996	0	UNK	PVT	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960080000	1						1	Injection site hypersensitivity; Injection site mass; Injection site reaction; Urticaria	FLU3~PARKE-DAVIS~00596P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099437	05/29/1997	MA				U	11/11/1996	pt recv vax late OCT96 & devel an inj site rxn w/a quarter-sized welt w/redness & induration;pt recovered;									Y	10/01/1996	10/01/1996	0	UNK	PVT	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960081000	1						1	Injection site hypersensitivity; Injection site mass; Injection site reaction; Urticaria	FLU3~PARKE-DAVIS~00596P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099438	05/29/1997	MA				U	11/11/1996	pt recv vax in late OCT96 & devel inj site rxn w/a quarter-sized welt w/redness & induration;pt recovered;This is 1 of 5 pt;									Y	10/01/1996	10/01/1996	0	UNK	PVT	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960082000	1						1	Injection site hypersensitivity; Injection site mass; Injection site reaction; Urticaria	FLU3~PARKE-DAVIS~00596P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099439	05/29/1997	MA				U	11/11/1996	pt recv vax late OCT96 & devel general malaise;pt recovered									Y	10/01/1996	10/01/1996	0	UNK	PVT	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960085000	1						1	Malaise	FLU3~PARKE-DAVIS~00596P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099440	05/29/1997	WA	45.0			F	11/11/1996	pt recv vax 31OCT96 & 3NOV96 pt exp dizziness;has no hx of an egg or chicken allergy;									U	10/31/1996	11/03/1996	3	UNK	OTH	OTH	UNK		hx of no allergy to eggs or chicken;	~ ()~~~In patient	010150960086000	1						1	Dizziness	FLU3~PARKE-DAVIS~00176P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099441	05/29/1997	MD				F	11/11/1996	pt recv vax 24OCT96 & 1NOV96 & w/in 24hr p/vax pt devel an inj site rxn between 6-15cm in diameter w/redness, swelling & itching;									U	10/01/1996	10/01/1996	0	UNK	PVT	OTH	NONE	UNK	NONE	~ ()~~~In patient	010150960087000	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PARKE-DAVIS~00276P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099442	05/29/1997	MD				M	11/11/1996	pt recv vax between 24OCT96 & 1NOV96;w/in 24hr p/vax pt devel an inj site rxn between 6-15cm in diameter w/redness, swelling & itching;this is 1 of 3 pt;									U	10/24/1996	10/25/1996	1	UNK	PVT	OTH	UNK	UNK	NONE	~ ()~~~In patient	010150960088000	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PARKE-DAVIS~00276P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099443	05/29/1997	MD				F	11/11/1996	pt recv vax between 24OCT96 & 1NOV96 & w/in 24hr p/vax pt devel an inj site rxn between 6-15cm in diameter w/redness, swelling & itching;									U	10/24/1996	10/25/1996	1	UNK	PVT	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960089000	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PARKE-DAVIS~00276P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099444	05/29/1997	MD				U	11/10/1996	pt recv vax between 24OCT96 & 1NOV96 & devel a fever & stiff neck 24hr p/vax;									U	10/24/1996	10/25/1996	1	UNK	PVT	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960092000	1						1	Nuchal rigidity; Pyrexia	FLU3~PARKE-DAVIS~00276[~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099445	05/29/1997	MD				U	11/12/1996	pt recv vax NOV96 & devel an inj site rxn w/redness, swelling & itching;the affected area is about the size of a BP cuff (4 x 10);									U	11/01/1996	11/01/1996	0	UNK	PVT	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960093000	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PARKE-DAVIS~00276P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099446	05/29/1997	MD				U	11/12/1996	pt recv vax NOV96 & devel an inj site rxn w/redness, swelling & itching;the affected area is about the size of a BP cuff (4 x 10);this case was reported by a MD;									U	11/01/1996	11/01/1996	0	UNK	PVT	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960094000	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PARKE-DAVIS~00276P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099447	05/29/1997	MD				U	11/12/1996	pt recv vax NOV96 & devel an inj site rxn w/redness, swelling & itching;the affected area is about the size of a BP cuff (4 x 10);this case was reported by MD; cross reference w/DER 0010150960093/94, DER 0010150960096 to DER0010150960102;									U	11/01/1996	11/01/1996	0	unk	PVT	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960095000	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PARKE-DAVIS~00276P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099448	05/29/1997	MD				U	11/12/1996	pt recv vax NOV96 & devel an inj site rxn w/redness, swelling, & itching;the affected area is about the size of a BP cuff (4 x 10);this case was reported by MD;cross reference w/DER 0010150960093/95, DER 0010150960097 to DER 0010150960102									U	11/01/1996	11/01/1996	0	UNK	PVT	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960096000	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PARKE-DAVIS~00276P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099449	05/29/1997	MD				U	11/12/1996	pt recv vax NOV96 & devel an inj site rxn w/redness, swelling & itching;the affected area is about the size of BP cuff (4 x 10);this case was reported by a MD;cross reference w/DER0010150960093/96, DER 0010150960098 to DEr 0010150960102;									U	11/01/1996	11/01/1996	0	UNK	PVT	OTH	unk	unk	unk	~ ()~~~In patient	010150960097000	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PARKE-DAVIS~00276P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099450	05/29/1997	MD				U	11/12/1996	pt recv vax NOV95 & devel an inj site w/redness, swelling & itching;the affected area is about the size of a BP cuff (4 x 10);this case was reported by a MD;cross reference w/ DER 0010150960093/97, DER 0010150960099 to DER 0010150960102;									U	11/01/1996	11/01/1996	0	UNK	PVT	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960098000	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PARKE-DAVIS~00276P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099451	05/29/1997	MD				U	11/12/1996	pt recv vax NOV96 & devel an inj site rxn w/redness, swelling & itching;the affected area is about the size of a BP cuff (4 x 10);this was reported by MD;cross reference w/DER 0010150960093/98, DER0010150960100/102;									U	11/01/1996	11/01/1996	0	UNK	PVT	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960099000	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PARKE-DAVIS~00276P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099452	05/29/1997	MD				U	11/12/1996	pt recv vax NOV96 & devel an inj site rxn w/redness, swelling & itching;the affected area is about the size of BP cuff (4 x 10);this case reported by MD;cross reference w/DER0010150960093/99, DER0010150960101/102;									U	11/01/1996	11/01/1996	0	UNK	PVT	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960100000	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PARKE-DAVIS~00276[~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099453	05/29/1997	MD				U	11/12/1996	pt recv vax NOV96 & devel an inj site rxn w/redness, swelling & itching;the affected area is about the size of a BP cuff (4 x 10);this case was reported by MD;cross reference w/DER 0010150960093 to DER 0010150960100, DER 0010150960102;									U	11/01/1996	11/01/1996	0	UNK	PVT	OTH	unk	unk	unk	~ ()~~~In patient	010150960101000	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PARKE-DAVIS~00276P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099454	05/29/1997	MD				U	11/12/1996	pt recv vax NOV96 & devel an inj site rxn w/redness, swelling & itching;the affected area is about the size of a BP cuff (4 x 10);this case was reported by MD;cross reference w/DER0010150960093 to DER0010150960101;									U	11/01/1996	11/01/1996	0	UNK	PVT	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960102000	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PARKE-DAVIS~00276P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099455	05/29/1997	CA	67.0	67		M	12/03/1996	pt recv vax & devel severe burns on arms, skin that felt like leather & itchy skin on 17OCT96, 1 day p/vax;pt went golfing p/vax & was exposed to the sun;pt med hx is remarkable for HTN, hypercholesterolemia & arthritis;									Y	10/16/1996	10/17/1996	1	NONE	PVT	OTH	Dyazide, Lescol, Probenecid	UNK	hx of HTN, hypercholesterolemia, arthritis;	~ ()~~~In patient	010150960103000	1						1	Pain; Pruritus; Skin disorder	FLU3~PARKE-DAVIS~01186P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099456	05/29/1997	NC	72.0			M	11/14/1996	pt recv vax & devel soreness @ the inj site (lasting 36-48hr) & h/a;pt exp redness & swelling from the inj site to the elbow & pain;dx cont for 3 days a/beginning to subside;									Y	10/15/1996	10/15/1996	0	UNK	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960105000	1						1	Injection site hypersensitivity; Injection site oedema; Pain	FLU3~PARKE-DAVIS~00586P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099457	05/29/1997	OR	74.0	74		F	12/31/1996	pt recv vax 4NOV96 & 1hr & 1/2 later lip & lt side of face became swollen;pt returned to MD office where was given DPH & adrenalin;the next day lip was still swollen & voice was hoarse;prescribed pred;				Y					Y	11/04/1996	11/04/1996	0	NONE	PVT	PVT	Lasix, Minipress, potassium chloride;	abd pain	HTN & non-insulin dependent diabetes mellitus;	~ ()~~~In patient	010150960106000	1						1	Dysphonia; Face oedema	FLU3~PARKE-DAVIS~00586P~2~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099458	05/29/1997	NJ				U	01/03/1997	pt recv vax & devel pain & stiffness lasting two to three days post inj;									Y	10/01/1996	10/01/1996	0	UNK	PVT	OTH	unk	unk	unk	~ ()~~~In patient	010150960109000	1						1	Back pain; Hypertonia	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099459	05/29/1997	NM	53.0			F	11/14/1996	pt recv vax 31OCT96 & pt exp red flushing all over, tingling all over, & paresthesia in arms, trunk & legs;pt treated w/DPH;sx resolved w/in 1hr;pt was not hosp;skin test indicated was not allergic to chicken egg;									Y	10/31/1995	10/31/1996	366	skin test negative for allergy to chicken egg;	PUB	OTH	Ventolin, Azmacort, Serevent, Vasotec, Birth control	UNK	cough viriant asthma;sulfite sensitivity;no allergy to chicken eggs;	~ ()~~~In patient	010150960110000	1						1	Paraesthesia; Vasodilatation	FLU3~PARKE-DAVIS~0096P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099460	05/29/1997	IA				M	11/15/1996	pt recv vax NOV96 & devel an unspecified rxn;									U	11/01/1996	11/01/1996	0	UNK	OTH	OTH	UNK	UNK	UNk	~ ()~~~In patient	010150960114000	1						1	Unevaluable event	FLU3~PARKE-DAVIS~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099461	05/29/1997	OH				U	11/15/1996	pt recv vax & devel an anaphylactic rxn w/disseminated hives;									U				UNK	MIL	OTH	UNK	UNK	no hx of allergy to eggs;	~ ()~~~In patient	010150960116000	1						1	Anaphylactoid reaction; Urticaria	FLU3~PARKE-DAVIS~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099462	05/29/1997	OH				U	11/15/1996	pt recv vax & devel an inj site rxn w/a knot the size of a walnut @ the inj site;									U				unk	MIL	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960117000	1						1	Injection site mass	FLU3~PARKE-DAVIS~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099463	05/29/1997	OH				U	11/18/1996	pt recv vax & devel an inj site rxn;the inj site had a red wheal w/white dot in the center;									U				UNK	MIL	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960118000	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099464	05/29/1997	OH				U	11/18/1996	pt recv vax & devel an inj site rxn;the inj site had a red wheal w/a white dot in the center;									U				UNK	MIL	OTH	unk	unk	unk	~ ()~~~In patient	010150960119000	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099465	05/29/1997	VA	5.0	5		F	01/03/1997	pt recv vax 31OCT96 & has hx of severe allergies;1NOV96 pt devel hives;pt was seen for sx;pt has recovered;				Y					Y	10/31/1996	11/01/1996	1	NONE	PVT	OTH	Vancenase AQ	UNK	severe allergies	~ ()~~~In patient	010150960120000	1						1	Urticaria	FLU3~PARKE-DAVIS~00176P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099466	05/29/1997	IA	27.0	27		F	12/27/1996	pt recv vax 31OCT96 & w/in half an hr post inj pt devel a narrowing of visual field (homonymous hemianopsia) followed by lightheadedness & fatigue;all sx abated w/in a few hr;									Y	10/31/1996	10/31/1996	0	NONE	OTH	PVT	UNK	UNK	no hx of migraines or prev homonymous hemianopsia	~ ()~~~In patient	010150960121000	1						1	Asthenia; Dizziness; Visual field defect	FLU3~PARKE-DAVIS~01186P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099467	05/29/1997	IA	36.0	36		F	12/27/1996	pt recv vax 18OCT96 & w/in 1/2hr post inj pt devel a narrowing of visual field (homonymous hemianopsia) followed by lightheadedness & fatigue;sx abated w/in a few hr;									Y	10/18/1996	10/18/1996	0	NONE	OTH	PVT	UNK	UNK	no hx of migraines;	~ ()~~~In patient	010150960122000	1						1	Asthenia; Dizziness; Visual field defect	FLU3~PARKE-DAVIS~00576P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099468	05/29/1997	GA	40.0	40		F	11/21/1996	pt recv vax 13NOV96 & 14NOV96 pt devel an inj site rxn 3inches in diameter w/redness, induration & erythema;pt seen in MD ofc 15NOV96;pt exp aches, malaise & nausea;				Y					Y	11/13/1996	11/14/1996	1	UNK	PVT	OTH	Lo/ovral, Centriu, Advil	UNK	allergies to PCN, Declomycin, Tetanus toxin, insect stings, tetanus anitoxin;no hx of rxn p/prev flu vax;	~ ()~~~In patient	010150960130000	1						1	Injection site hypersensitivity; Injection site mass; Malaise; Myalgia; Nausea	FLU3~PARKE-DAVIS~6F71306~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099469	05/29/1997	NY	55.0	55		F	12/27/1996	20NOV96 pt noted a black bruise @ inj site which persists;pt notified MD & no treatment was prescribed;half dollar sized & purplish w/induration @ inj site;diff breathing;queasy & v, serum sickness w/hepatic involvement, resp infect;									N	11/19/1996	11/20/1996	1	NONE	PVT	OTH	Verapamil PRN, TB skin test, PEPCID PRN, Methionine	UNK	HTN	~ ()~~~In patient	010150960131000	1						1	Dyspnoea; Ecchymosis; Hepatic function abnormal; Infection; Injection site hypersensitivity; Injection site mass; Serum sickness; Skin disorder	FLU3~PARKE-DAVIS~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099470	05/29/1997	NJ				U	12/11/1996	pt recv vax 1NOV96 & pt devel vomiting & diarrhea w/o fever 48hr p/inj;pharmacist related there were other pt that exp vomit & diarrhea who did not recv vax;this is one of 25 cases reported;									U	11/01/1996			UNK	OTH	OTH	UNK	UNK	23OCT96 nause &vomiting;	~ ()~~~In patient	010150960132000	1						1	Diarrhoea; Vomiting	FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099471	05/29/1997	NJ				U	12/11/1996	pt recv vax 1NOV96 pt devel vomit & diarrhea w/o fever 48hr p/inj;this is 1 of 25 cases reported;									U	11/01/1996			UNK	OTH	OTH	UNK	UNK	22OCT96 n/v	~ ()~~~In patient	010150960133000	1						1	Diarrhoea; Vomiting	FLU3~PARKE-DAVIS~00586P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099473	05/29/1997	PA	73.0	72		F	11/26/1996	pt recv vax 12NOV96 & pt exp nocturnal lt leg cramping on 14NOV96;the next morning both legs felt sore;pt also reported that lt foot feels numb from time to time;sx were improving;pt past med hx is remarkable for HTN;									N	11/12/1996	11/14/1996	2	NONE	PVT	PVT	Procardia XL, cardura	UNK	HTN	~ ()~~~In patient	010150960136000	1						1	Muscle spasms; Pain; Paraesthesia	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099474	05/29/1997	IL				F	01/21/1997	pt exp strange sensation down arm, & up into neck & chest 10min p/vax on 11OCT96;pt described it as like but not really numbness;it lasted about 45min & there were no residual effects other than soreness @ the site;also exp a migraine h/a;									Y	10/11/1996	10/11/1996	0	none reported	PVT	OTH	UNK	UNK	migraines in conjunction w/the beginning of menses	~ ()~~~In patient	010150960137000	1						1	Injection site pain; Migraine; Paraesthesia	FLU3~PARKE-DAVIS~00576P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099475	05/29/1997	CA				U	01/06/1997	pt exp soreness @ inj site, numbness radiating down the arm, & hip pain p/vax in arm;									U				UNK	PVT	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960138000	1						1	Arthralgia; Injection site pain; Paraesthesia	FLU3~PARKE-DAVIS~00476P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099476	05/29/1997	CA				U	01/06/1997	It was reported that up to twenty pt exp soreness @ the inj site 2wk p/vax;									Y				UNK	PVT	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960139000	1						1	Injection site pain	FLU3~PARKE-DAVIS~0047P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099477	05/29/1997	WI	28.0	28		F	12/03/1996	pt recv vax & devel flu-like sx (fever, cough & aching) on 21NOV96 p/vax on 29OCT96;pt was seen by MD 25NOV96 for these sx & was reported by RN;				Y					N	10/29/1996	11/20/1996	22	influenza virus antibody type A-16 H	PVT	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960140000	1						1	Cough; Influenza; Myalgia; Pyrexia	FLU3~PARKE-DAVIS~00966P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099478	05/29/1997	NC	63.0	63		F	12/05/1996	pt recv vax 3NOV96 & 3NOV96 pt devel an inj site rxn approx 2 x 1: that was reddened w/itching;the area inc to the size of a grapefruit w/the skin raised & arm was sore;pt used Lanacane for the itching which provided temp relief;									N	11/03/1996	11/03/1996	0	UNK	PUB	OTH	UNK	UNK	hx of allergies to compazine, pred, tenormin, & ATB	~ ()~~~In patient	010150960142000	1						1	Injection site hypersensitivity; Injection site mass; Myalgia; Pruritus	FLU3~PARKE-DAVIS~00786P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099479	05/29/1997	NC	45.0	45		F	12/05/1996	pt devel fever 30NOV96 p/vax on 22NOV96;pt devel a rash over most of body;pt also had muscle aches, joint pain, stiffness & swelling of hands;the hives had the appearance of sunburn from the neck down;inc WBC;serum sickness vs viral URI;				Y					Y	11/22/1996	11/30/1996	8	inc WBC prior to fluogen vaccine;	PVT	OTH	Azmacort, Seldane, Vancenase, Albuterol	inc WBC prior to fluogen;	hx of asthma;allergy to PCN;	~ ()~~~In patient	010150960143000	1						1	Arthralgia; Hypertonia; Myalgia; Oedema peripheral; Pyrexia; Rash; Serum sickness; Urticaria	FLU3~PARKE-DAVIS~01186P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099480	05/29/1997	NC				U	12/05/1996	pt recv vax OCT96 & devel a h/a;this is one of five cases reported by a RN;cross reference to 0010150960105 & 0010150960145 through 00100150960147;									U	10/01/1996	10/01/1996	0	UNK	PUB	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960144000	1						1	Headache	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099481	05/29/1997	NC				U	12/05/1996	pt recv vax OCT96 & devel a h/a;this is one of five cases reported by RN;cross reference to 0010150960105 & 0010150960144 to 0010150960147;									U	10/01/1996	10/01/1996	0	UNK	PUB	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960145000	1						1	Headache	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099482	05/29/1997	NC				U	12/05/1996	pt recv vax OCT96 & devel a h/a;this is one of five cases reported by a RN;cross reference to 0010150960144 to 0010150960147									U	10/01/1996	10/01/1996	0	UNK	PUB	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960146000	1						1	Headache	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099602	05/29/1997	WI				M	11/11/1996	pt has been exp tinnitus p/vax OCT95 & sx is ongoing;this was reported by MD:pt has not yet recovered from tinnitus;									N	01/01/1995	10/01/1995	273	nl audiogram	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150970035000	1						1	Tinnitus	FLU3~PARKE-DAVIS~~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099603	05/29/1997	NC				U	12/05/1996	pt recv vax OCT96 & devel a h/a;this is one of five cases reported by RN;									U	10/01/1996	10/01/1996	0	UNK	PUB	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150960147000	1						1	Headache	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099604	05/29/1997	NY	54.0	54		F	04/29/1997	pt recv vax 15OCT96 & 22OCT96 devel redness w/burnt-like skin, bruising, skin eruptions & a burning sensation on feet;tx by dermatologist w/cream & ointments w/o improvement;sx d/t allergic rxn to flu;redness w/burn sensation spread to hand				Y					U	10/15/1996	10/22/1996	7	cult negative for fungus;cult for herpes-results unk	PVT	OTH	Zovirax, Cipro	UNK	hx of herpes lesions in lips, viral encephalitis 1988;no hx of rxn to prev flu vax herpes encephalitis;	~ ()~~~In patient	010150960148000	1						1	Ecchymosis; Hypersensitivity; Pain; Skin disorder; Vasodilatation	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099605	05/29/1997	NY	60.0	60		F	12/10/1996	pt recv vax 2DEC96 & the next day 3DEC96 pt devel redness @ the inj site;pt reported that has improved;									N	12/02/1996	12/03/1996	1	UNK	PVT	PVT	SYnthroid	UNK	hypothyroidism, allergy to PCN	~ ()~~~In patient	010150960149000	1						1	Injection site hypersensitivity	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099606	05/29/1997	PA	65.0	64		F	02/12/1997	pt recv vax 11OCT96 & NOV96 devel a false positive human T cell lymphotrophic virus;this case was reported by MD:red cross dated 25NOV96 stating that blood tested indeterminate for HTLV-1;pt is no longer able to donate blood;				Y						10/11/1996	11/05/1996	25	false positive human T cell lymphotrophic virus type I (HTLV I);	OTH	OTH		UNK	NONE	~ ()~~~In patient	010150960150000	1						1	Laboratory test abnormal	FLU3~PARKE-DAVIS~00966P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099607	05/29/1997	FL	55.0	55		F	12/18/1996	pt exp burning @ the inj site which stopped upon completion of vax;w/in 2hr of vax pt devel h/a, gen malaise, low grade fever, dizziness, tiredness, blurred vision & nausea;fever resolved in 24hr & tiredness improving;muscle weakness;				Y					N	11/05/1996	11/06/1996	1	UNK	PVT	OTH	UNK	UNK	hx of fever, aches, & pains for 3 days p/1995 flu shot;	~ ()~~~In patient	010150960151000	1						1	Amblyopia; Asthenia; Dizziness; Headache; Injection site pain; Myasthenic syndrome; Nausea; Pyrexia	FLU3~PARKE-DAVIS~01066P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099608	05/29/1997	MA	29.0	28		M	01/22/1997	pt recv vax 30OCT96 & 23DEC96 pt devel flu sx of fever, nausea, anorexia, weakness & labored breathing;pt seen by MD;no tx were prescribed;pt has not yet recovered as of 30DEC96;				Y					Y	10/30/1996	12/23/1996	54	throat cult neg;	PVT	OTH	ventolin inhaler, multivitamins, decongestants, APAP;	UNk	asthma (not on meds @ this time), no rxn to prev flu vax;	~ ()~~~In patient	010150970002000	1						1	Anorexia; Asthenia; Dyspnoea; Influenza; Nausea; Pyrexia	FLU3~PARKE-DAVIS~00886P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099609	05/29/1997	FL	54.0			F	12/06/1996	pt recv vax & devel flu sx of fever, aches & pains p/vax in 1995;sx lasted 3 days & pt recovered;									Y				UNK	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150970004000	1						1	Influenza; Myalgia; Pyrexia	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099610	05/29/1997	NY	81.0	81		F	01/08/1997	pt recv vax OCT96 & 24DEC96 & pt exp laryngitis, fever 101 & bad cough;dx w/flu & was treated w/ATB; pt has not yet recovered;				Y					N	10/01/1996	12/24/1996	84	UNK	PVT	PVT	prevacid, Nolvadex, pred, forte,ASA,propranolol	UNK	HTN	~ ()~~~In patient	010150970010000	1						1	Cough; Drug ineffective; Infection; Laryngitis; Pyrexia	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099611	05/29/1997	NY				M	12/23/1996	pt recv vax & devel the flu;this case was reported by the pt;									U				UNK	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150970011000	1						1	Influenza	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099612	05/29/1997	NJ				U	12/18/1996	an unspecified # of pt exp lack of effect p/vax;									U	11/01/1996			UNK	PVT	OTH	UNK	UNK	unk	~ ()~~~In patient	010150970013000	1						1	Drug ineffective	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099613	05/29/1997	NE				U	12/17/1996	multiple pt recv vax & devel flu;the reporter indicated pt had been vaccinated w/on of the recalled lot but was unable to identify a specific lot#;									U				UNk	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150970014000	1						1	Influenza	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099614	05/29/1997	ID	34.0			M	12/17/1996	pt recv vax 5NOV96 & 7NOV96 pt exp fatigue & flu sx (low grade fever, myalgia, lower back pain);pt has not yet recovered;									N	11/05/1996	11/07/1996	2	UNK	PVT	PVT	NONE	UNK	NONE	~ ()~~~In patient	010150970015000	1						1	Asthenia; Back pain; Influenza; Myalgia; Pyrexia	FLU3~PARKE-DAVIS~0176P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099615	05/29/1997	AR	63.0	63		F	12/26/1996	pt recv vax 22NOV96 & 7DEC96 pt devel a sore throat & was treated w/ATB;sore throat abated;pt devel sniffles & was not sure if it was allergies or a cold;									Y	11/22/1996	12/07/1996	15	UNK	PVT	PVT	inhalers,claritin	unk	allergies/emphysema;	~ ()~~~In patient	010150970016000	1						1	Pharyngitis; Rhinitis	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099616	05/29/1997	NE	74.0	74		F	12/23/1996	pt recv vax OCT96 & 26NOV96 pt devel cough, congestion, sl h/a, exhaustion & required med tx;pt has not yet recovered;				Y					N	10/01/1996	11/26/1996	56	UNK	OTH	OTH	calcium supplement	UNK	NONE	~ ()~~~In patient	010150970017000	1						1	Asthenia; Cough; Headache; Rhinitis	FLU3~PARKE-DAVIS~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099617	05/29/1997	ID	49.0	49		M	12/17/1996	pt recv vax 5NOV96 & 7NOV96 pt exp severe low back pain that has been lasting for over six weeks, also devel flu sx;pt has not yet recovered;									N	11/05/1996	11/07/1996	2	UNK	PVT	PVT	Proscar, cardura	UNK	chronic back pain, herniated disk, prostatitis;	~ ()~~~In patient	010150970018000	1						1	Back pain; Influenza	FLU3~PARKE-DAVIS~00176P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099618	05/29/1997	CT	62.0			F	12/18/1996	pt recv vax & exp cough, fever, malaise & myalgia p/vax;pt also had sore throat;									Y	10/01/1996	12/16/1996	76	UNK	PVT	PVT	Premarin, Provera, Synthroid, moduretic, flonase	UNK	hx of asthma, HTN, esophageal reflus, hypothyroidism;	~ ()~~~In patient	010150970019000	1						1	Cough; Malaise; Myalgia; Pharyngitis; Pyrexia	FLU3~PARKE-DAVIS~00176P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099619	05/29/1997	FL	67.0	67		F	12/20/1996	pt recv vax OCT96 & 16DEC96 pt devel coughing, weakness & migraine;by 20DEC96 pt was feeling better;									N	10/01/1996	12/16/1996	76	UNK	OTH	PVT	NONE	UNk	NONE	~ ()~~~In patient	010150970020000	1						1	Asthenia; Cough; Migraine	FLU3~PARKE-DAVIS~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099620	05/29/1997	CT	32.0			F	12/18/1996	pt recv vax & exp flu sx on 18DEC96 described as myalgias, sore throat, fever & cough for 1wk p/vax;pt recovered;									Y	11/11/1996	12/18/1996	37	UNK	PVT	PVT	Azmacort, Albuterol	UNK	hx of asthma & bronchitis;	~ ()~~~In patient	010150970021000	1						1	Cough; Influenza; Myalgia; Pharyngitis; Pyrexia	FLU3~PARKE-DAVIS~00176P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099621	05/29/1997	OH	68.0	68		M	12/18/1996	pt recv vax 17OCT96 & 10DEC96 pt exp flu sx & was seen by MD who prescribed ATB;				Y					Y	10/17/1996	12/10/1996	54	UNk	OTH	OTH	UNK	UNK	controlled HTN, arthritis	~ ()~~~In patient	010150970022000	1						1	Influenza	FLU3~PARKE-DAVIS~00886P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099622	05/29/1997	NE	76.0	76		M	12/23/1996	pt recv vax OCT96 & 26NOV96 pt devel congestion, sl h/a, exhaustion, & cough requiring med eval;pt has not yet recovered;pt indicated had been vaccinated w/one of the recalled lots, but was unable to ID a specific lot#				Y					N	10/01/1996	11/26/1996	56	UNK	OTH	OTH	NONE	UNK	NONE	~ ()~~~In patient	010150970023000	1						1	Asthenia; Cough; Headache; Rhinitis	FLU3~PARKE-DAVIS~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099623	05/29/1997	CT				F	12/18/1996	pt exp lack of effect p/flu vax;									Y	10/01/1996			UNK	PVT	PVT	unk	unk	hx of asthmatic bronchitis;	~ ()~~~In patient	010150970024000	1						1	Drug ineffective	FLU3~PARKE-DAVIS~00176P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099624	05/29/1997	CT				U	01/14/1997	pt recv vax NOV96 & pt exp flu sx & had a positive viral cult;pt treated w/rimantadine;reporter indicated pt had been vaccinated w/one of the recalled lots, but was unable to ID a specific lot#									U	11/01/1996	12/01/1996	30	postive viral cult;	PUB	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150970025000	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099625	05/29/1997	CT				U	01/14/1997	pt recv vax early NOV96 & pt exp flu sx had a positive viral cult;pt tx w/rimantadine;reported indicated pt had been vaccinated w/on of the recalled lots but was unable to ID specific lot#									U	11/01/1996	12/01/1996	30	positive viral cult	PUB	OTH	UNk	UNK	UNK	~ ()~~~In patient	010150970026000	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099626	05/29/1997	CT				U	01/14/1997	pt recv vax & exp flu sx & a positive viral cult;pt was treated w/rimantadine;reporter indicated pt had been vaccinated w/one of the recalled lots, but was unable to ID a specific lot#;									U	11/01/1996	12/01/1996	30	positive viral cult	PUB	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150970027000	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099627	05/29/1997	CT				U	01/14/1997	pt recv vax & exp flu sx & had a positive viral cult;pt tx w/rimantadine;reporter indicated pt had been vaccinated w/one of the recalled lots, but was unable to ID specific lot#;									U	11/01/1996	12/01/1996	30	positive viral cult	PUB	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150970028000	1						1	Drug ineffective; Infection; Influenza	FLU3~PARKE-DAVIS~~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099628	05/29/1997	CT	45.0	45		M	02/14/1997	pt recv vax 15OCT96 & 11DEC96 pt devel a fever of 100.4, malaise, myalgia, & cough productive of small amounts of yellow sputum;also exp 2 noc of profuse sweating;pt has not yet recovered;t103, chills, myalgia, felt sick;									Y	10/15/1996	12/11/1996	57	UNK	PVT	PVT	NONE	UNK	NONE	~ ()~~~In patient	010150970029000	1						1	Chills; Cough; Hyperhidrosis; Malaise; Myalgia; Pyrexia	FLU3~PARKE-DAVIS~00176P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099629	05/29/1997	MD	61.0	61		F	12/18/1996	pt recv vax & devel a swollen, red, painful & itchy arm, 2 days p/vax;inj site rxn lasted 7 days;pt has a med hx of chronic bronchitis;pt has recovered;									Y	11/01/1996			UNK	PVT	PVT	UNK	UNK	hx chronic bronchitis;	~ ()~~~In patient	010150970030000	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus	FLU3~PARKE-DAVIS~00176P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099630	05/29/1997	ID	53.0	53		F	12/17/1996	pt recv vax & exp vomit, diarrhea, dehydration & lower back pain 7NOV96 w/in 48hr of vax;pt went to ER & needed to have IV rehydration;pt med hx is remarkable for HTN, upper back pain & severe scoliosis;				Y					N	11/05/1996	11/07/1996	2	blood count negative;chem panel negative;EKG negative;	PVT	PVT	Monopril, nasal spray, estorgen, alfentanil	UNK	hx of severe scoliosis, hypertension, upper back pain;	~ ()~~~In patient	010150970031000	1						1	Back pain; Dehydration; Diarrhoea; Vomiting	FLU3~PARKE-DAVIS~00176P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099631	05/29/1997	MO	29.0	29		M	01/16/1997	pt recv vax OCT96 & 23DEC96 pt devel a fever over 100, chills, a cough, congestion,  nausea which lasted over 3wk;pt required a physician exam & was prescribed ATB;all of sx have resolved x/for cough;				Y					N	10/01/1996	12/23/1996	83	NONE	PUB	OTH	NONE	UNK	NONE	~ ()~~~In patient	010150970032000	1						1	Chills; Cough; Nausea; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099632	05/29/1997	RI	61.0	61		F	12/23/1996	pt recv vax 10OCT96 for flu vax;18DEC96 devel chills, throat & ear infect, congestion, & ached all over;pt was eval by MD & prescribed ATB;pt recovered;pt revaccinated w/one of recalled lots but unable to ID specific lot#;				Y					Y	10/10/1996	12/18/1996	69	UNK	OTH	PVT	NONE	UNK	NONE	~ ()~~~In patient	010150970033000	1						1	Chills; Infection; Myalgia; Otitis media; Pharyngitis; Rhinitis	FLU3~PARKE-DAVIS~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099633	05/29/1997	NE	66.0	66		F	12/20/1996	pt recv vax 30OCT96  & 3DEC96 pt exp fever & head & chest congestion;pt recovered from all sx w/x/of persisting cough;pt vax w/recalled lots unable to ID specific lot#:									N	10/30/1996	12/03/1996	34	UNK	OTH	OTH	NONE	UNK	NONE	~ ()~~~In patient	010150970034000	1						1	Cough; Lung disorder; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099634	05/29/1997	KS	24.0			M		pt recv vax & devel a local rxn;this case was reported by RN;									U				UNK	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150970036000	1						1	Injection site reaction	FLU3~PARKE-DAVIS~~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099635	05/29/1997	VA	70.0	70		F	12/20/1996	pt recv vax 6OCT96 & 16DEC96 pt exp chills, fever, cough & h/a;pt was examined by MD who dx pt w/resp flu;pt was prescribed an ATB, an inhaler, & a cough syrup;pt med hx is remarkable for triple bypass surgery in APR93 & arthritis;				Y					N	10/06/1996	12/16/1996	71	NONE REPORTED	PVT	PVT	ASA, Pravachol, Cataflam	UNk	triple bypass surgery in APR93, arthritis	~ ()~~~In patient	010150970037000	1						1	Chills; Cough; Headache; Influenza; Lung disorder; Pyrexia	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099636	05/29/1997	NY	84.0	84		M	12/19/1996	pt recv vax SEP96 & NOV96 pt exp loss of appetite, aches, & pains, backache,  diarrhea;pt examined by MD;CXR & profile 6 were both negative;pt has not yet recovered;pt recv vax w/one of the recalled lots, unable to ID specific lot#:				Y					N	09/01/1996	11/01/1996	61	profile 6 & CXR negative;	PVT	PVT	vitamins	UNK	NONE	~ ()~~~In patient	010150970038000	1						1	Anorexia; Back pain; Diarrhoea; Myalgia; Pain	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099637	05/29/1997	VA	64.0	64		M	01/03/1997	pt recv vax 3NOV96 & 24DEC96 pt devel temp, chills, weakness, n/v for 3 to 4 days;MD prescribed antiviral & nausea med;pt has not recovered;				Y					N	11/03/1996	12/24/1996	51	NONE	PVT	PVT	Insulin	UNK	hx diabetes	~ ()~~~In patient	010150970040000	1						1	Asthenia; Chills; Nausea; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099638	05/29/1997	OH	43.0	43		F	01/07/1997	pt recv vax OCT96 & 1DEC96 pt exp fatigue, h/a, & stomach pains for 2wk;4JAN97 pt started having a sore throat, h/a, fever, aches all over & fatigue;pt has not yet recovered;									N	10/01/1996	12/01/1996	61	NONE	OTH	PVT	NONE	UNK	NONE	~ ()~~~In patient	010150970041000	1						1	Abdominal pain; Asthenia; Headache; Pharyngitis; Pyrexia	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099639	05/29/1997	CA	22.0	22		M	12/19/1996	pt recv vax 11DEC96 & 14DEC96 pt exp h/a, coughing, congestion, fatigue, eyes felt swollen & felt like had temp;pt has not yet recovered;									N	12/11/1996	12/14/1996	3	NONE	PVT	PVT	decongestant	UNK	NONE	~ ()~~~In patient	010150970042000	1						1	Asthenia; Cough; Face oedema; Headache; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099640	05/29/1997	IA	71.0			F	01/15/1997	pt recv vax & devel a head cold that moved to chest, fits of coughing & was coughing up phlegm;pt visited MD twice & was dx w/bronchial infect;MD prescribed 3 courses of ATB & cough syrup;blood work was negative x/high uric acid;CXR negativ				Y					N				Blood work negative x/for high uric acid, CXR negative;	PVT	PUB	Thyroid med, med for angina	unk	hx thyroid condition, heart condition, fractured ribs AUG96;	~ ()~~~In patient	010150970043000	1						1	Bronchitis; Cough; Hyperuricaemia; Infection; Lung disorder; Rhinitis	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~UNKNOWN MANUFACTURER~~1~IM A~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0099641	05/29/1997	NY				U	12/11/1996	pt recv vax & devel localized tenderness @ inj site & dec ROM lasting more than 1-1/2months;this case was reported by MD;									U				UNK	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150970045000	1						1	Hypokinesia; Injection site pain; Movement disorder	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099642	05/29/1997	IN	52.0	52		M	01/09/1997	pt recv vax 1OCT96 & arm started aching between elbow & shoulder the same day recv vax;pt reported arm feels like there is something still there because arm still aches four mo later;this case was reported by consumer;									N	10/01/1996	10/01/1996	0	NONE	PVT	PVT	NONE	UNK	NONE	~ ()~~~In patient	010150970046000	1						1	Myalgia	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099643	05/29/1997	SD	33.0	33		F	12/17/1996	pt recv vax 23OCT96 & pt exp myalgia, h/a, temp up to 100.5 & productive cough;13DEC96 a nasal swab was positive for influenza A;MD prescribed amantadine;pt reports feeling better not 100%;this case was reported by pt who is also a LPN;				Y					Y	10/23/1996	12/13/1996	51	nasal swab positive for influenza A	PVT	PVT	NONE	UNK	NONE	~ ()~~~In patient	010150970047000	1						1	Cough; Drug ineffective; Headache; Infection; Myalgia; Pyrexia	FLU3~PARKE-DAVIS~00276P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099644	05/29/1997	NY	76.0	76		M	12/19/1996	pt recv vax OCT96;pt also taking zocor, cardizem, inderal & carafate;3wk p/vax pt devel flu sx from which pt subsequently recovered;6wk later exp similar sx but worse which included myalgia, cough, wheezing & t102;pt has not yet recovered;				Y					N	10/01/1996	11/01/1996	31	CBC negative	PUB	PVT	Zocor, inderal, cardizem, carafate	unk	heart condition	~ ()~~~In patient	010150970048000	1						1	Asthma; Cough; Influenza; Myalgia; Pyrexia	FLU3~PARKE-DAVIS~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099645	05/29/1997	CT	47.0			M	12/18/1996	pt recv vax OCT96 & 13DEC96 pt exp a fever of 100.4, malaise, myalgia & hacking cough w/yellow sputum;pt missed 3 days of work d/t sx;pt has not yet recovered as of 18DEC96;MD 7FEB97 revealed that pt exp fever, chills,body aches, cough;									Y	10/01/1996	12/12/1996	72	UNK	PVT	PVT	NONE		NONE	~ ()~~~In patient	010150970049000	1						1	Chills; Cough; Malaise; Myalgia; Pyrexia	FLU3~PARKE-DAVIS~00176P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099646	05/29/1997	GA	70.0	70		M	12/17/1996	pt recv vax 30SEP96 & 16DEC96 devel chills, cough, high fever, diff breathing;pt was eval by MD who dx flu & prescribed PCN & cough syrup;pt has not yet recovered;				Y					N	09/30/1996	12/16/1996	77	UNK	PUB	UNK		unk	NONE	~ ()~~~In patient	010150970050000	1						1	Chills; Cough; Drug ineffective; Dyspnoea; Infection; Pyrexia	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099647	05/29/1997	MN	56.0	56		M	12/17/1996	pt recv vax 1OCT96 & 15OCT96 pt devel severe vomiting & diarrhea;p/2 days pt was eval in Er & was hydrated IV;MD felt that pt had food poisoning & should be adm but the pt chose to leave several hr later;stool specimen was positive for food				Y					Y	10/01/1996	10/15/1996	14	stool psecimen positive for food poisoning;	OTH	OTH	NONE	UNK	NONE	~ ()~~~In patient	010150970051000	1						1	Dehydration; Diarrhoea; Vomiting	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099648	05/29/1997	NY	54.0			F	12/17/1996	pt recv vax 15OCT96 & DEC96 pt exp malaise, myalgia, cough & t100.4;10FEB97 MD confirmed pt exp fever, chills, myalgias & cough in DEC96;cough persisted for 2wk;pt since recovered;									Y	10/15/1996	12/01/1996	47	UNK	PVT	PVT	NONE	UNK	UNK	~ ()~~~In patient	010150970053000	1						1	Cough; Malaise; Myalgia; Pyrexia	FLU3~PARKE-DAVIS~00176P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099649	05/29/1997	NY	72.0			F	12/06/1996	pt recv vax 12OCT96 & arm was tender to touch w/tired feeling in arm;pt exp pain w/& w/o use of the arm sometimes radiating to the elbow & to the neck & shoulder;As of 4FEB97 only has pain w/a sudden or unexpected movement;									U	10/12/1996	10/12/1996	0	UNK	PUB	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150970054000	1						1	Hypokinesia; Myasthenic syndrome; Pain	FLU3~PARKE-DAVIS~00775P~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099650	05/29/1997	PA	56.0	55		F	12/30/1996	pt recv vax 16OCT96 & 3DEC96 pt exp fever, sore throat, cough, muscles aches & fatigue for 2 1/2wk;pt has not yet recovered;pt indicated had been vaccinated w/one of the recalled lot, but unable to ID specific lot#;									N	10/16/1996	12/03/1996	48	NONE	OTH	PVT	NONE	UNK	NONE	~ ()~~~In patient	010150970055000	1						1	Asthenia; Cough; Myalgia; Pharyngitis; Pyrexia	FLU3~PARKE-DAVIS~~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099651	05/29/1997	MI	73.0	73		F	12/30/1996	pt recv vax OCT96 & 18DEC96 pt could not eat, had h/a, chills, fever 103, nausea, diarrhea, & gen weakness;pt has not yet recovered;									Y	10/01/1996	12/18/1996	78	NONE	OTH	PUB	Vitamins	UNk	NONE	~ ()~~~In patient	010150970057000	1						1	Anorexia; Asthenia; Chills; Diarrhoea; Headache; Nausea; Pyrexia	FLU3~PARKE-DAVIS~~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099652	05/29/1997	MI	59.0	59		M	12/27/1996	pt recv vax 24OCT96 & 24DEC96 pt devel hot & cold flashes, a sore throat, congestion & gen weakness;pt has not yet recovered;									N	10/24/1996	12/24/1996	61	UNK	PVT	PVT	Multiple unspecififed med	UNK	diabetes Type II & heart condition	~ ()~~~In patient	010150970058000	1						1	Asthenia; Chills; Pharyngitis; Rhinitis; Vasodilatation	FLU3~PARKE-DAVIS~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099653	05/29/1997	AR	66.0	66		F	04/02/1997	pt recv vax 16OCT96 & 21DEC96 started having a sore throat;2 days later pt had chills, congestion, fatigue but not fever;									U	10/16/1996	12/21/1996	66	NONE	OTH	OTH	Prozac, Premarin, APAP, Xanax, Proventil, darvocet;	UNK	hx brain surgery in 1993, allergy to PCN & codeine;	~ ()~~~In patient	010150970059000	1						1	Asthenia; Chills; Pharyngitis; Rhinitis	FLU3~PARKE-DAVIS~~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099655	05/29/1997	CA	72.0	72		F	03/06/1997	pt recv vax OCT96 & 29DEC96 pt unable to eat for two days, was sweating, vomiting & had an asthma attack;31DEC96 dx w/kidney infect;tx w/ATB & has recovered;MD determined pt sx were r/t kidney infect & not flu vax;				Y					Y	10/01/1996	12/29/1996	89	UNK	PVT	PVT	Atrovent, theophylline, ventolin	UNK	asthma, hayfever, migraines;	~ ()~~~In patient	010150970061000	1						1	Anorexia; Asthma; Condition aggravated; Hyperhidrosis; Infection; Vomiting	FLU3~PARKE-DAVIS~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099656	05/29/1997	NJ	66.0	66		M	01/22/1997	pt recv vax NOV96 & exp diarrhea, weight loss & flu sx beginning 7DEC96;sx still persist;pt is taking glucose for diabetes & an unk pain med for migraines;pt indicated had been vaccinated w/one of the recalled lots but was unable to ID lot#									N	11/01/1996	12/07/1996	36	UNK	PUB	PUB			hx of diabetes, migraines & equilibium problems;	~ ()~~~In patient	010150970062000	1						1	Diarrhoea; Influenza; Weight decreased	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099657	05/29/1997	TX	71.0	71		F	12/30/1996	24DEC96 pt had sore throat, chest pain when coughing, high fever & muscle weakness causing pt to fall;pt also coughing up phlegm;pt seen by MD;pt recovered had a relapse around 10JAN97;exp weakness,bladder incontinence, dizziness, hoarse				Y					N	11/01/1996	12/24/1996	53	NONE	PVT	PVT	Tamoxifen, Atenolol	UNK	hx of breast cancer, glaucoma & heart problem;	~ ()~~~In patient	010150970063000	1						1	Chest pain; Coordination abnormal; Cough; Dizziness; Dysphonia; Myasthenic syndrome; Pharyngitis; Urinary incontinence	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099658	05/29/1997	WA	51.0	51		M	01/02/1997	pt recv vax 31OCT96 & did not feel well on 3NOV96;pt also lethargic & achy as well;approx 2wk later pt devel chest pain & taken to ER where MD said had a virus attacking the muscle around heart;1mo later pt came down w/flu & devel pneumonia				Y					N	10/31/1996	11/17/1996	17	UNK	OTH	OTH			hx of allergic rxn to indocin	~ ()~~~In patient	010150970064000	1						1	Asthenia; Chest pain; Drug ineffective; Infection; Influenza; Malaise; Myalgia; Pneumonia	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099659	05/29/1997	CT	39.0			F	12/18/1996	pt recv vax OCT96 & exp high fever & flu sx;11FEB97 MD confirmed on 5DEC96 pt exp cough, aches, & chills;									Y	10/01/1996	12/05/1996	65	UNK	PVT	PVT	UNK	UNK	asthma	~ ()~~~In patient	010150970065000	1						1	Chills; Cough; Influenza; Myalgia; Pyrexia	FLU3~PARKE-DAVIS~00176P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099660	05/29/1997	PA				U	12/17/1996	pt recv vax in OCT or NOV96;an unk # of pt were vaccinated w/flu vax;12DEC96 over 40 pt devel the flu however it is not known how many of thee pt recv flu;									U	10/01/1996	12/12/1996	72	UNK	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150970066000	1						1	Drug ineffective; Infection	FLU3~PARKE-DAVIS~00586P~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099661	05/29/1997	IA				M	01/16/1997	pt recv vax & pt caught the flu p/shot;this case was reported by the consumer;									U				UNK	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150970068000	1						1	Influenza	FLU3~PARKE-DAVIS~~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099662	05/29/1997	IA	50.0	50		F	03/10/1997	pt recv vax 14OCT96 & c/o of soreness in rt arm which was cont across to back & lt arm;pt was seen by MD;CXR negative;pt has not yet recovered;rt shoulder discomfort, especially worse @ noc;tendonitis;				Y					N	10/14/1996	10/22/1996	8	CXR & arm x-ray negative;	PVT	PVT	Ibuporfen, Premarin	UNK	NONE	~ ()~~~In patient	010150970069000	1						1	Arthralgia; Back pain; Pain; Tendon disorder	FLU3~PARKE-DAVIS~00986P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099663	05/29/1997	OH	53.0	52		M	01/23/1997	pt recv vax in OCT96 & 14DEC96 pt devel flu sx for 2wk;28DEC96 pt devel a fever blister;pt was seen by MD & ATB were prescribed;pt has recovered;pt indicated had been vaccinated w/one of the recalled lots, but was unable to ID specific lot				Y					Y	10/01/1996	12/14/1996	74	NONE	UNK	UNK	NONE	UNK	NONE		010150970070000	1						1	Dermatitis bullous; Influenza	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0099664	05/29/1997	OH	50.0	49		F	01/22/1997	pt recv vax OCT96 & 23DEC96 pt started having n/v, t101.0 lasted for 3 days;pt has recovered;pt had a viral synd 2mo p/vax;pt thought it was the flu;MD told pt the hx was more consistent w/gastroenteritis;									Y	10/01/1996	12/23/1996	83	NONE	OTH	PVT	Cardizem CD, Zantac, Premarin, unspecified fluid pill	UNK	high BP, heart blockage, allergy to codeine, swelling @ inj site p/flu vax age 47;	~ ()~~~In patient	010150970071000	1						1	Gastroenteritis; Infection; Influenza; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~00276T~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099665	05/29/1997	OH	67.0			M	01/23/1997	pt recv vax & started having a sore throat & congestion for 1wk;pt contacted MD & ATB were prescribed over the phone;pt has recovered;									Y				NONE	OTH	PVT	ASA, Prinivil	UNk	blocked lt carotid artery, high BP, allergic to Bactrim;	~ ()~~~In patient	010150970072000	1						1	Pharyngitis; Rhinitis	FLU3~PARKE-DAVIS~00276P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099666	05/29/1997	OH	48.0	48		M	01/22/1997	pt recv vax OCT96 & 23DEC96 pt started having a fever, vomiting, & diarrhea;pt has recovered;									Y	10/01/1996	12/23/1996	83	NONE	OTH	PVT	NONE	UNK	NONE	~ ()~~~In patient	010150970073000	1						1	Diarrhoea; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~00276T~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099667	05/29/1997	IA	47.0	47		F	01/22/1997	pt recv vax 19OCT96 & 24DEC96 pt started having a fever, chills, diarrhea, vomiting, & heartburn;pt felt sick for 2wk;pt saw MD & med was prescribed for heartburn;pt has recovered;				Y					Y	10/19/1996	12/24/1996	66	NONE	PUB	OTH	NONE	UNK	NONE	~ ()~~~In patient	010150970074000	1						1	Chills; Diarrhoea; Gastrointestinal disorder; Malaise; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099668	05/29/1997	IA	53.0	53		F	01/22/1997	pt recv vax 19OCT96 & 26DEC96 pt devel fever 101-102, coughing, sinus drainage, fatigue;fatigue & coughing lasted 2wk;pt contacted MD who prescribed cough medicine, ATB & a sulfa med;pt recovered;				Y					Y	10/19/1996	12/26/1996	68	NONE	OTH	PVT	Insulin, Carafate, Zantac, Premarin	UNK	diabetes	~ ()~~~In patient	010150970075000	1						1	Asthenia; Cough; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099669	05/29/1997	IA	50.0	50		M	01/22/1997	pt recv vax 19OCT96 & 20DEC96 started having diarrhea, vomiting, fever, chills, & heartburn for 4 days;pt saw MD & was prescribed heartburn med;pt recovered;				Y					Y	10/19/1996	12/20/1996	62	NONE	PUB	PUB	NONE	UNK	NONE	~ ()~~~In patient	010150970076000	1						1	Chills; Diarrhoea; Gastrointestinal disorder; Pyrexia; Vomiting	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099670	05/29/1997	OH	26.0	26		F	01/23/1997	pt recv vax OCT96 & 2JAN97 pt started having flu sx;pt was off of work 4 days & was so tired could not move;pt saw allergy MD & pred recommended;pt recovered;				Y					Y	10/01/1996	01/02/1997	93	NONE	OTH	PVT	UNK	UNK	asthma	~ ()~~~In patient	010150970077000	1						1	Asthenia; Hypokinesia; Influenza	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099671	05/29/1997	OH	31.0	31		F	01/23/1997	pt recv vax OCT96 & 20DEC96 pt was tired & had chills & an asthma attack was triggered;pt was seen by MD & has recovered;				Y					Y	10/01/1996	12/20/1996	80	NONE	OTH	PVT	UNK	UNK	asthma, arthritis	~ ()~~~In patient	010150970078000	1						1	Asthenia; Asthma; Chills; Condition aggravated	FLU3~PARKE-DAVIS~~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099672	05/29/1997	OH	64.0	64		F	01/23/1997	pt recv vax OCT96 & 24DEC96 pt started having fatigue & a sl fever for over 1wk & a cough that lingered;pt has recovered;									Y	10/01/1996	12/24/1996	84	NONE	OTH	PVT	Premarin	UNK	allergic to Bactrim	~ ()~~~In patient	010150970080000	1						1	Asthenia; Cough; Pyrexia	FLU3~PARKE-DAVIS~~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099673	05/29/1997	OH				M	01/23/1997	pt recv vax OCT96 & 18DEC96 pt started to ache all over & had a fever, drainage & blood from the sinuses & had a lump in throat (swollen gland);saw MD who said bronchial tubes were closed & lungs were swollen;sore throat & swollen gland;				Y					N	10/01/1996	12/18/1996	78	strep throat cult-negative;	OTH	OTH	NONE	UNK	NONE	~ ()~~~In patient	010150970081000	1						1	Bronchitis; Lymphadenopathy; Myalgia; Pharyngitis; Pulmonary oedema; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099674	05/29/1997	OH	67.0	67		M	01/27/1997	pt recv vax & 4wk p/vax pt started having chills & sweating for 1noc;also had a cough that persisted for 6wk;pt recovered;									Y	10/01/1996	11/01/1996	31	NONE	OTH	PVT	Glyburide	UNK	borderline diabetic	~ ()~~~In patient	010150970083000	1						1	Chills; Cough; Hyperhidrosis	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099675	05/29/1997	FL				F	01/27/1997	pt recv vax & exp transverse myelitis p/vax;pt has not yet recovered;sx still persists;									N				UNK	OTH	OTH	UNK	UNK	UNK	~ ()~~~In patient	010150970085000	1						1	Myelitis	FLU3~PARKE-DAVIS~~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099676	05/29/1997	MI	56.0	56		F	01/30/1997	pt recv vax 17OCT96 & same day pt passed out p/blood rushed to head, ear were ringing & had heart palpitation;19OCT96 devel laryngitis extreme weakness, shakes for 2 days;NOV96 exp panic attacks;dx mild depression;17OCT96 sweating;				Y					N	10/17/1996	10/17/1996	0	5DEC96 blood & urine tests-nl;12DEC96 stress test nl;6DEC96 EKG nl;	OTH	OTH	Estrogen	UNK	NONE	~ ()~~~In patient	010150970086000	1						1	Agitation; Asthenia; Depression; Hyperhidrosis; Palpitations; Syncope; Tinnitus; Tremor	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099678	05/29/1997	TX	23.0	23		F	02/27/1997	pt recv vax & devel warmth & redness (10cm area) @ inj site & pain on 25FEB97 p/inadvertently recv flu vax instead of APlisol;fluogen was given SC on lt arm;pt has not yet recovered;									N	02/25/1997	02/25/1997	0	NONE	OTH	OTH		UNK	NONE	~ ()~~~In patient	010150970089000	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PARKE-DAVIS~~1~SC A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099680	05/29/1997	PA	85.0	85		M	02/26/1997	pt recv vax 21OCT96 & 4FEB97 pt exp an inc temp of 100, confusion & malaise;4FEB97 resp viral cult was positive for influenza A;tx included Flumadine on 3FEB97 for 21 days;pt recovered;this is 1 of 28 cases;				Y					Y	10/21/1996	02/04/1997	106	4FEB97 resp viral cult positive for influenza A	OTH	OTH		UNK	HTN, dementia, aortic sclerosis, benign prostatic hypertrophy;	~ ()~~~In patient	010150970094000	1						1	Confusional state; Drug ineffective; Infection; Malaise; Pyrexia	FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099681	05/29/1997	PA	81.0	81		F	02/26/1997	pt recv vax 21OCT96 & 3FEB97 pt exp a temp of 100, loose cough & nasal congestion;4FEB97 pt had resp virus cult positive for influenza A;tx included flumadine on 3FEB97 for 21 days;pt recovered;this is 1 of 28 cases;				Y					Y	10/21/1996	02/03/1997	105	resp viral cult-positive for infuenza A 4FEB97;	OTH	OTH	UNK	UNK	hx of NIDDM, cerebrovascular disease, urinary retention, dementia;	~ ()~~~In patient	010150970095000	1						1	Cough; Drug ineffective; Infection; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099691	05/29/1997	PA	72.0	72		F	02/26/1997	pt recv vax 23OCT96 & 2FEB97 pt exp an inc temp & a moist cough;tx w/Proventil, Robitussin & Flumadine 3FEB97 for 2wk & was reordered on 18FEB97;this is 1 of 28 cases;									Y	10/23/1996	02/02/1997	102	NONE	OTH	OTH	UNK	UNK	dysphagia, weight loss, MS, reflux esophagitis;	~ ()~~~In patient	010150970105000	1						1	Cough; Pyrexia	FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0099696	05/29/1997	PA	100.0			F	02/26/1997	pt recv vax 23OCT96 & 30JAN97 pt exp t99.8, cough, & nasal congestion;tx included flumadine 4FEB97 for 21 days;pt recovered;this is 1 of 28 cases;				Y					Y	01/23/1996	01/30/1997	373	NONE	OTH	OTH	UNK	UNK	hx of arteriosclerotic heart disease, cardiovascular disease	~ ()~~~In patient	010150970110000	1						1	Cough; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0099705	05/29/1997	FL	25.0	25		F	03/17/1997	pt recv vax 8NOV96 & few days p/vax pt devel hives on forearms, shoulders, chest, back & legs;has no prev hx of allergy to eggs;hives persisted & in JAN97 steroids were prescribed;				Y					N	11/08/1996	11/11/1996	3	blood work WNL;	PUB	OTH	Triphasil	unk	no hx of allergy to eggs;	~ ()~~~In patient	010150970120000	1						1	Urticaria	FLU3~PARKE-DAVIS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0098454	06/02/1997	IA	62.0			F	05/09/1997	weakness, pain lower extremities,  GBS vs myopathy secondary to Zocor;thought to be GBS more than Zocor myopathy;? r/t vax;					Y	10	Y	Y	Y	02/26/1997	02/26/1997	0	EMG + deneration;	UNK	UNK	clinoril;Zocor		allergies Demerol;	~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome; Myasthenic syndrome; Myopathy; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0094834	06/04/1997	TN	42.0	42		M	06/03/1997	pt recv vax 31OCT96 12 days post vax 12NOV96 pt exp paralysis in lt arm;nero said pt had a form of GBS;pt lt leg was reported effected too;pt reports that has exp severe fatigue over the last 6mo;				Y					N	10/31/1996	11/12/1996	12		UNK	UNK				~ ()~~~In patient	CO7308	1						2	Guillain-Barre syndrome; Hypokinesia; Paraesthesia; Skin nodule; Asthenia; Guillain-Barre syndrome; Paralysis	FLU3~CONNAUGHT LABORATORIES~6F71227~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0098497	06/04/1997	IA	39.0	38		F	11/03/1996	pt recv vax & felt tightness in throat;severe pain in arm & couldn't lift arm;JAN97 call MD still couldn't move arm;MD felt probable rotary cuff tendinitis;pt to physical therapy;arm & shoulder getting worse;still painful;								Y		11/03/1996	11/03/1996	0		UNK	UNK			allergies to mold, pollens, sulfa, PCN;alcohol 1-2mo;I do have alot of low back pain, heel pain, bursitis hip, arthritis, psoriasis, asthma;	~ ()~~~In patient		1						1	Arthralgia; Hypokinesia; Injection site pain; Laryngospasm; Pain; Tendon disorder; Hypokinesia; Injection site pain; Myalgia; Tendon disorder	FLU3~PFIZER\WYETH~4968169~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Disabling	Influenza
0098733	06/09/1997	NH	41.0	41		F	06/03/1997	asthma-using ventolin inhaler since JAN;sinus congestion;seen 6JAN;				Y					N	10/16/1996			CXR-clear	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	NH97016	1						1	Asthma; Rhinitis	FLU3~MEDEVA PHARMA, LTD.~E3106GC~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0099006	06/13/1997	NY	73.0			M		lt arm pain-same arm as flu shot;supra? deltoid atrophy;EMG affected on axillary suprascapular, median nerve;								Y		10/02/1996	10/05/1996	3	EMG affected on axillary suprascapular, median nerves;	UNK	UNK	Prilosec & propulsid on reg basis			~ ()~~~In patient		1						1	Laboratory test abnormal; Muscle atrophy; Neuropathy; Pain	FLU3~PFIZER\WYETH~4968185~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0098802	06/18/1997	KY	50.0			F	02/05/1997	achiness & rash/hives 24yr p/vax;no history of allergy;									Y	10/23/1995	10/24/1995	1		OTH	OTH	Premerin	NONE	no allergy history, smoker	~ ()~~~In patient	CO6242	1						1	Myalgia; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~5F61116~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0099196	06/20/1997	WA	46.0	46		F	11/05/1996	sx started 25OCT96 7 days p/vax rt side of face started not to work;droopy side of face;couldn't chew, dx bell's palsy;relapsed 31OCT96 put back on pred;weak & tired;facial paralysis improved but still present to a sl degree;				Y					Y	10/18/1996	10/25/1996	7		OTH	OTH				~ ()~~~In patient	WA971321	1						1	Asthenia; Facial palsy	FLU3~PFIZER\WYETH~6249006~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0099286	06/24/1997	HI	39.0	39		F	05/12/1997	pt claims that was dx w/trigeminal neuropathy around thanksgiving time 1996;pt only mentioned this today 12MAY97;				Y					Y	10/17/1996			?	MIL	UNK	NONE	NONE	asthma	NONE~ ()~~~In patient		1						1	Neuropathy	FLU3~PFIZER\WYETH~4968203~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0099330	06/26/1997	AZ	62.0	62		U	06/18/1997	pt recv vax & arm ached;pt noticed sunken place;pt described it as a big hole w/nothing left but skin over the bone;pt stated it just ached;MD said ti was SC fat atrophy from inj site post flu vax;;residula is a dimple post inf lt deltoid;				Y						10/26/1996			283	OTH	PVT		NONE	arthritis	NA~ ()~~~In patient		1						1	Myalgia; Skin atrophy	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0095585	06/29/1997	PA	78.0	77		M	02/26/1997	pt recv vax 22OCT96 & 10FEB97 pt exp a sore throat, runny nose & t99;11FEB9 exp a cough & nasal congestion;exp resp viral cult was positive for influenza A;tx included Biaxin for 7 days, Albuterol & Flumadine on 3FEB97 x 2wk;				Y					Y	10/22/1996	02/10/1997	111	11FEB97 resp viral cult positive for influenza A	OTH	OTH	UNK	UNK	hx of cerebrovascular accident x2, chronic atrial fibrillation;	~ ()~~~In patient	010150970087000	1						2	Cough; Drug ineffective; Infection; Pharyngitis; Pyrexia; Rhinitis; Cough; Drug ineffective; Infection; Pharyngitis; Pyrexia; Rhinitis	FLU3~PARKE-DAVIS~00296P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKE-DAVIS~00296P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0099365	06/30/1997	GA	72.0			F		pt recv vax & became weaker during the day,upon admission was markedly quadraparetic;could move head & speaks w/diff;CBC WNL;adm w/GBS;intubated on ventilator;tracheostomy performed 24NOV96;			Y		Y			Y	U	11/02/1996	11/19/1996	17	CBC WNL; 9.3/39.1;13.5;321; 138/3.7/108/23.4/6/0.7;139;	UNK	UNK		upper resp sx 3wk prior to admission;	PMH x/hysterectomy 50yrs PTA;			1						1	Asthenia; Guillain-Barre syndrome; Hyperchloraemia; Hyperglycaemia; Hypoxia; Laboratory test abnormal; Quadriplegia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0092835	07/01/1997	MO	35.0	35		F	06/27/1997	pt recv vax 28OCT96 10AM & 430PM pt began to exp following sx evolved over the course of approx 2wk: lightheadedness, raise in BP, muscle wekaness, muscle fasciculations, extreme fatigue, shakness of limbs, incoordination, loss of balance;				Y	Y	3			N	10/28/1996	10/28/1996	0	MRI, CT-scan, 2 LP, 2CXR, EMG, stress test, EEG, Echocariagram, currently undergoing physical therapy;	OTH	OTH	NONE	reported as none	no pre-existing allergies, birth defects or medical conditions;	~ ()~~~In patient	CO7348	1						3	Coordination abnormal; Dizziness; Hypertension; Hypokinesia; Muscle twitching; Myasthenic syndrome; Tremor; Asthenia; Coordination abnormal; Dizziness; Hypertension; Muscle twitching; Myasthenic syndrome; Tremor	FLU3~CONNAUGHT LABORATORIES~6F71239~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2|TTOX~CONNAUGHT LABORATORIES~5L71095~UNK~~~TETANUS TOXOID (NO BRAND NAME)~2|FLU3~CONNAUGHT LABORATORIES~6F71239~1~~~INFLUENZA (SEASONAL) (FLUZONE)~3|TD~CONNAUGHT LABORATORIES~5L71095~UNK~~~TD ADSORBED (NO BRAND NAME)~3	USA	Hospitalisation	Influenza
0098497	07/02/1997	IA	39.0	38		F	06/23/1997	pt recv vax 2NOV96 & still could not move lt arm;pt did not get any better the weeks past;MD felt poss tenditis;site of inj remained sore;									N	11/02/1996	11/05/1996	3	MRI done 4JUN97;	OTH	UNK		NONE	sulfa, PCN;allergies to dust, pollen, mold	pt exp diff in breathing @ 33yr w/ PCN;~ ()~~~In patient		1						2	Arthralgia; Hypokinesia; Injection site pain; Laryngospasm; Pain; Tendon disorder; Hypokinesia; Injection site pain; Myalgia; Tendon disorder	FLU3~PFIZER\WYETH~4968169~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0099574	07/02/1997	VA	32.0			F		pt recv vax 13NOV96 & 26NOV96 pt exp rash;									U	11/13/1996	11/26/1996	13	No relevant data;	PVT	PVT				~ ()~~~In patient	WAES96120306	1						1	Rash; Rash maculo-papular	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0074894	07/07/1997	TX	51.0	51		F	06/13/1997	24hr p/vax fever, chills, myalgia, h/a intermittent x 3wk then blind (black) spots started that progressed over 2wk-optic neuritis-neuropathy bilat-w/onset visual disturbance peripheral partial vision rt eye-partial splotchy vision lt eye;								Y	N	10/17/1994	10/18/1994	1	LP-MRI-carotid toppler all WNL; DEC94 ESR 10; IGG profile WNL ex IGG G 248;anti A nl;ANA nl CBC nl exc  13.7 WBC Henselae antibody panel nl;Cardiolipid AB nl;RPR NB;Cat Scratch titer;Henselac IGG 1:1024 <1:256;Henselae IGM <1:20, <1:20;	PVT	PVT	Dyazide	NONE	allergy PCN, Zestril	NONE~ ()~~~In patient	TX97072	1						3	Chills; Headache; Myalgia; Neuropathy; Optic neuritis; Pyrexia; Visual disturbance; Visual field defect	FLU3~PFIZER\WYETH~4948146~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~3	USA	Disabling	Influenza
0099823	07/07/1997	GA	72.0			F		pt recv vax & became weaker during the day;upon admission pt markedly quadraparetic;could move head & speak w/o diff;CBC WNL;adm evolving GBS;intubated on ventilator;tracheostomy;			Y		Y			Y		11/01/1996	11/19/1996	18	CBC WNL; 9.3;39.1;13.5;321; Na 138;Potassium 3.7;Cl 108;Bicarb 23.4;BUN 6;Creat 0.7; glucose 139;	UNK	UNK			PMH x/hystercetomy-50yr PTA:upper resp	~ ()~~~In patient		1						1	Dysphagia; Guillain-Barre syndrome; Hyperchloraemia; Hyperglycaemia; Hypokinesia; Hypoxia; Laboratory test abnormal; Quadriplegia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0100132	07/10/1997	SD	37.0	37		F	12/10/1996	pt reported on 10DEC96 that on 26OCT96 about 8PM started getting blisters on inside of bottom lip;they were hot, red & itchy lasted about 1wk;cold air bothered them;used med on them which helped;did not seek med attention;pt ? if r/t vax;									Y	11/26/1996				PUB	PUB	NA	NONE	allergic to PCN but no other known allergies;		SD97005	1						1	Dermatitis bullous; Mouth ulceration; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71322~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0100133	07/10/1997	SD	13.0	13		M	11/27/1996	p/flu shot given pt exp persistent nausea @ 12hr p/shot lasting about 10 days;also had bodyaches/lack of energy-fatigu for 20 dasy;did not see MD;									Y	10/23/1996	10/24/1996	1		PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	SD97004	1						1	Asthenia; Myalgia; Nausea	FLU3~CONNAUGHT LABORATORIES~67F1273~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0100134	07/10/1997	SD	61.0	61		M	11/21/1996	pt reported arm is still sore to the touch & it is worse @ noc it lay on it;denies s/s of infect;21NOV pt states arm is getting better;pt states can put on coat & sleep @ noc w/o OTC pain med;									Y	10/24/1996	10/24/1996	0	NONE	PUB	PUB	NONE	no illness @ the time	NKMA	NONE~ ()~~~In patient	SD97003	1						1	Hypokinesia; Insomnia; Myalgia	FLU3~CONNAUGHT LABORATORIES~6F71273~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0100135	07/10/1997	SD	57.0	57		M	11/21/1996	pt recv vax & noted tenderness in arm 25OCT96;called MD office 5NOV96 stating arm is still sore & it's worse when rase arm;no bump, reddness, no warmth;states soreness worse w/movement;cont to c/o soreness not improved;									U	10/24/1996	10/25/1996	1	NONE	OTH	PUB	HTN med	HTN	HTN	NONE~ ()~~~In patient	SD97002	1						1	Hypokinesia; Myalgia	FLU3~CONNAUGHT LABORATORIES~6F71273~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0100767	07/10/1997	SD	59.0	59		M	12/10/1996	GBS				Y	Y	10			Y	10/08/1996	10/22/1996	14		OTH	OTH	Wellbutrin;Valproic acid;Genifibrozi;Adulat CC, ASA	UNK	PCn allergy, Bipolar, hypercholesterolemia, hypertriglyceridermia;	NONE~ ()~~~In patient	SD97006	1						1	Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~6F71273~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0096512	07/18/1997	NY	74.0	74		M	01/15/1997	pt recv vax & exp a feeling of weakness, sick feeling & tired;next day fainted & had loose bowels, severe sweating, loss of appetite, weakness in legs;pt recovered @ the date of this report;									Y	10/09/1996	10/09/1996	0		PVT	PVT	Anafranil;HCTZ, Zestril	NONE	obsessive compulsive disorder, anxiety, HTN	pt recv vax w/o adverse exp;~ ()~~~In patient	897072002L	1						2	Asthenia; Convulsion; Faecal incontinence; Hyperhidrosis; Injury; Malaise; Nausea; Syncope; Anorexia; Asthenia; Diarrhoea; Hyperhidrosis; Malaise; Myasthenic syndrome; Syncope	FLU3~PFIZER\WYETH~~2~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968173~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0100325	07/18/1997	SC	43.0			F	01/06/1997	pt exp gen arthralgia p/vax;									Y					PVT	PVT	unk	unk		pt exp gen arthralgia p/vax (see MCn 896330037L);~ ()~~~In patient	897099009L	1						1	Arthralgia	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0100352	07/18/1997	FL	63.0	63		F	07/03/1997	pt recv vax & exp transverse myelitis p'/vax;pt has not yet recovered, sx still persits;vax given 29SEP94;pt still exp transverse myelitis on 13OCT94;EMG performed on 12OCT96;3JUL97 related that became paralyzed p/vax;								Y	N	09/29/1994	09/30/1994	1	12OCT96 EMG	PVT	OTH	unk	unk	hx of non-insulin dependent diabetes mellitus, hypothyroidism, chronic back pain synd, prev flu vax 6NOV92;	~ ()~~~In patient	010150970085001	1						1	Myelitis; Neuropathy; Paralysis	FLU3~PARKE-DAVIS~~2~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Disabling	Influenza
0100431	07/18/1997	OK				U	01/09/1997	pt recv vax 28OCT96 & devel influenza type A on 8JAN97 & was hosp;					Y				U	10/28/1996	01/08/1997	72		PUB	OTH	UNK	UNK		~ ()~~~In patient	897098007L	1						1	Drug ineffective; Infection	FLU3~PFIZER\WYETH~4968163~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0100432	07/18/1997	VA	78.0	78		M	01/27/1997	pt recv vax 25OCT96 & 29OCT fell & fractured hip, requiring surgery;p/surgery devel a urinary tract infect  & treated w/floxin;d/c from hosp on 1NOV;3NOV exp chest pain & rehosp;					Y				Y	10/24/1996	11/03/1996	10	26SEP Theophylline level 15.0;5NOV 25.4;11NOV 9.4;	OTH	PVT	Albuterol inhaler;Atrovent inhaler;Floxin, Theophylline, Vicodan, Ibuprofen, enulose, Bactrim;	unspecified infect	COPD, hx of sz, cataracts, hx of alcohol abuse, status post basal cell carcinoma, status post pneumonia, hx of fractures;	~ ()~~~In patient	897107028L	1						1	Bone disorder; Chest pain; Injury; Laboratory test abnormal; Urinary tract infection	FLU3~PFIZER\WYETH~~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0100487	07/18/1997	OH	78.0	78		F	12/30/1996	3 days p/vax pt devel redness & swelling @ inj site;this is 1 of 12 pt fromt hi site to have an adverse exp p/vax w/lot# 4968181;									Y	10/15/1996	10/18/1996	3		PVT	PVT	NONE	NONE		~ ()~~~In patient	897008011L	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4968181~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0100488	07/18/1997	MI	66.0	66		F	01/22/1997	pt recv vax 30DEC96 & 31DEC96 pt devel flu sx consisting of fever of 100, chills, shaking, nausea & fatigue;sx persisted for 24hr;									Y	12/30/1996	12/31/1996	1		OTH	OTH	Lodine XL	plantar fasciitis, bursitis	bursitis, plantar fasciitis, knee problems;	~ ()~~~In patient	897069004L	1						1	Asthenia; Chills; Influenza; Nausea; Pyrexia; Tremor	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0100489	07/18/1997	WV	34.0	34		F	02/10/1997	approx 2mo p/vax pt devel vertigo & elevated liver enzymes, which persisted @ date of this report;				Y					N	10/09/1996	12/15/1996	67		OTH	OTH	NONE	NONE		~ ()~~~In patient	897070009L	1						1	Hepatic function abnormal; Vertigo	FLU3~PFIZER\WYETH~4968159~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0100491	07/18/1997	MN	1.3			M	01/17/1997	pt recv vax 2JAN97 & 16JAN97 2wk p/vax & 4 days p/last dose of erythromycin pt devel a rash on arms, legs, & ears which consisted of red papules 2-3mm in diameter;reporting MD dx Giaonitti-Crosti synd;				Y					U	01/02/1997	01/16/1997	14		PVT	OTH	Erythromycin	UNK		~ ()~~~In patient	897072004L	1						1	Rash; Rash maculo-papular	FLU3~PFIZER\WYETH~~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0100492	07/18/1997	MT				U	02/07/1997	approx 2wk p/vax pt devel a psoriasis-like rash;the rash has gotten progressively worse, despite various unspecified treatments;				Y					U	11/01/1996				PUB	OTH	UNK	UNK		~ ()~~~In patient	897076013L	1						1	Rash	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0100493	07/18/1997	PA	59.0	59		M	01/24/1997	pt recv vax & 15NOV96 pt exp heaviness in the chest, dec appetite, h/a, dizziness, diarrhea, weakness, arthralgia, myalgia, foggy feeling in the head, noc sweats & chills;lost 14 pounds by 5JAN97;t100,anemic;internal bleeding confirmed;									U	11/15/1996				OTH	OTH	unk	NONE		~ ()~~~In patient	897076016L	1						1	Anaemia; Anorexia; Arthralgia; Chest pain; Confusional state; Myalgia; Pyrexia; Weight decreased	FLU3~PFIZER\WYETH~4968198~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0100494	07/18/1997	NC				F	03/04/1997	pt recv vax & devel an earache, sore throat, lethargy, & h/a;									U	10/03/1996	10/03/1996	0		OTH	OTH	UNK	UNK		~ ()~~~In patient	897077007L	1						1	Ear pain; Headache; Pharyngitis; Somnolence; Headache; Otitis media; Pharyngitis; Somnolence	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~~~PNEUMO (PNU-IMUNE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0100495	07/18/1997	FL	65.0	65		F	01/22/1997	pt exp pain @ inj site during vax;pt has cont to exp pain @ the inj when abducting the lt shoulder joint;pain is absent @ rest & during rotation of the lt shoulder;exp some relief while taking a medrol & Ibuprofen;									Y	10/01/1996	10/01/1996	0		PVT	PVT	Prempro	NONE	NONE	~ ()~~~In patient	897077026L	1						1	Hypokinesia; Injection site pain	FLU3~PFIZER\WYETH~4968138~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0100496	07/18/1997	FL	62.0	62		M	01/22/1997	pt recv vax 19DEC96 & devel flu-like sx & yellow phlegm which persisted @ the date of this report;also devel an inj site rxn which resolved p/a couple of days;									Y	12/19/1996	12/19/1996	0		PVT	PVT	Calan;IMDUR, Toprol;	NONE	angina, s/p pacemaker insertion, unspecified arrhythmia	~ ()~~~In patient	897078002L	1						1	Influenza; Injection site reaction	FLU3~PFIZER\WYETH~~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0100497	07/18/1997	IL	62.0	62		M	03/19/1997	pt recv vax & devel tinnitus in the rt ear;pt was seen by otolaryngologist who stated audiometric workup revealed a markedly asymmetric nerve deafness;pt was to have an MRI to r/o a retrocochlear lesion;				Y					N	10/20/1996	10/22/1996	2		OTH	OTH	Metoprolol, ASA, Vitamin E, Lorazepam, Xanax	UNK	status post coronary artery bypass surgery a few years ago;10-yr hx of hearing loss w/abn hearing tests several yrs ago;severe panic attacks;claustrophobia;	~ ()~~~In patient	897091032L	1						1	Condition aggravated; Deafness; Neuropathy; Tinnitus	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0100498	07/18/1997	WI	82.0	82		F	03/21/1997	approx 1mo p/vax pt devel swelling of both hands;pt had a h/a for 2wk prior to vax;the h/a persisted for 4wk post vax;pt underwent testing for lyme disease, CHF, & liver function;no abnormalities were found;				Y					U	10/04/1996	11/01/1996	28	lyme disease,CHF,liver function-no abnormalities were found;	OTH	OTH	Aleve	UNK		pt has recv flu vax for the past several yr;each time devel sinus h/a post vax;~ ()~~~In patient	897107016L	1						1	Condition aggravated; Oedema peripheral	FLU3~PFIZER\WYETH~4968178~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0100499	07/18/1997	CA	42.0	42		M	01/06/1997	pt recv vax OCT96 & 27DEC96 pt devel a sore throat followed by cough, fever & chills;									U	10/01/1996	12/27/1996	87		OTH	OTH	Redux	NONE		~ ()~~~In patient	897107018L	1						1	Chills; Cough; Pharyngitis; Pyrexia	FLU3~PFIZER\WYETH~~7+~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0100500	07/18/1997	VA	78.0	78		F	01/27/1997	pt recv vax 24OCT96 & 28OCT theophylline level was 17.3;this is 1 of 2 pt from this sit to devel elevated theophylline levels p/vax;pt theophylline dose was inc on 22OCT96;									Y	10/24/1996	10/28/1996	4	Theophylline level  21OCT 5.5, 28OCT 17.3;	OTH	PVT	Captopril;Colace,digoxin, Furosemide, Insulin, Isosorbide, mevacor, proventil inhaler, senekot, serevent inhaler, synthroid, theophylline, trazadone, vanceril inhaler;	NONE	COPD,hypothyroidism, depression, insulin-dependent diabetes mellitus, CHF, CAD, hyperlipidemia, sulfa allergy;	~ ()~~~In patient	897107025L	1						1	Laboratory test abnormal	FLU3~PFIZER\WYETH~~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0100501	07/18/1997	FL	80.0	80		F	03/10/1997	pt recv vax NOV96 & JAN97 it was noted that pt had atrophy @ the inj site described as necrosis to subdermal layers of site-uppermost layers intact;									U	11/01/1996	01/01/1997	61		PVT	OTH	unk	NONE		~ ()~~~In patient	897107026L	1						1	Injection site atrophy; Necrosis	FLU3~PFIZER\WYETH~~UNK~~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0100502	07/18/1997	WA	42.0			F	02/28/1997	pt recv vax fall 1996;later pt devel shingles;									U					OTH	OTH	unk	unk	chickenpox as a child;	~ ()~~~In patient	897108002L	1						1	Herpes zoster; Infection	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0100503	07/18/1997	ME	54.0	54		F	01/30/1997	pt recv vax & devel swelling of the axillary lymph nodes;pt recovered 48hr;this is 1 of 6 pt from this site to have an adverse exp following vax w/lot# 6968173									Y	10/21/1996				PUB	PVT	unk	unk	sulfa, flagyl allergies;L4/L5 herniated disc;	~ ()~~~In patient	897108006L	1						1	Lymphadenopathy	FLU3~PFIZER\WYETH~4968173~4~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0100504	07/18/1997	ME	21.0	21		F	01/30/1997	immed p/vax pt exp swelling & itching @ injs ite;this event resolved in less than 12hr;this is 1 of 6 pt from this site to have an adverse exp following vax w/lot# 4968173;									Y	11/07/1996	11/07/1996	0		PUB	PVT	unk	unk	PCN allergy	~ ()~~~In patient	897108007L	1						1	Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4968173~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0100505	07/18/1997	ME	42.0	42		F	01/30/1997	pt recv vax & devel a fever which persisted for 72hr, & swelling @ the inj site;pt recovered;this is 1 of 6 pt from this site to have an adverse exp following vax;									Y	10/24/1996				PUB	PVT	unk	unk	allergic to erythromycin, L5-S1 spondylolysis, spondylolisthesis;	~ ()~~~In patient	897108008L	1						1	Injection site oedema; Pyrexia	FLU3~PFIZER\WYETH~4968173~4~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0100506	07/18/1997	ME	28.0	28		F	01/30/1997	pt recv vax & devel an inj site rxn characterized by swelling & erythema;pt recovered p/2wk;this is 1 of 6 pt from this site to have an adverse exp following vax lot# 4968173									Y	10/08/1996	10/08/1996	0		PUB	PVT	UNK	NONE	Hirshsprung's Disease	~ ()~~~In patient	897108009L	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4968173~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0100507	07/18/1997	ME	23.0	23		F	01/30/1997	pt recv vax & that evening devel fatigue, chills, & sweats;pt then exp itching @ the inj site which spread from shoulder to elbow & a 2-inch area of swelling & erythema @ the inj site;pt recovered p/48-72hr;									Y	10/10/1996	10/10/1996	0		PUB	PVT	unk	unk	dust, mold, beesting & perfume allergies;asthma;	~ ()~~~In patient	897108010L	1						1	Asthenia; Chills; Hyperhidrosis; Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4968173~4~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0100508	07/18/1997	NE	30.0	30		M	11/07/1996	this is 1 of 5 pt;pt recv vax 23OCT96 & 4hr post vax pt devel body aches;the next day awoke w/body aches & nausea;2 days post vax pt had body aches, diarrhea, anorexia & weight loss;pt began to feel better 3 days post vax & recovery;									Y	10/23/1996	10/23/1996	0	NONE	PUB	PVT	UNK	cold	NONE	~ ()~~~In patient	896324012L	1						1	Anorexia; Arthralgia; Diarrhoea; Myalgia; Nausea; Weight decreased	FLU3~PFIZER\WYETH~4968172~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0100509	07/18/1997	MD	50.0	50		F	11/12/1996	pt recv vax & w/in 15min of pvax pt devel an allergic rxn characterized by a red, raised, itchy area @ the inj site;pallor;wheezing & lightheadedness;tx w/epi & DPH;									Y	10/17/1996	10/17/1996	0		PVT	OTH	Estrace;Flonase;Flovent;Levothroid;Prilosec;Serevent;Theo-dur;Ventolin;	NONE	asthma, allergies to pollens;	~ ()~~~In patient	896326001L	1						1	Asthma; Dizziness; Hypersensitivity; Injection site hypersensitivity; Injection site oedema; Pallor; Pruritus	FLU3~PFIZER\WYETH~4968144~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0100510	07/18/1997	SC	44.0	43		F	11/19/1996	3 days p/vax pt exp arthralgia;f/u info was recv 6JAN97;pt exp arthralgia in all joints;it was worse in the small joints;@ the time of f/u arthralgia persisted but was not as severe;									N	11/12/1996	11/15/1996	3		PVT	PVT	NONE	NONE		pt exp generalized arthralgias following flu vax 95/96;~ ()~~~In patient	896330037L	1						1	Arthralgia	FLU3~PFIZER\WYETH~4968138~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0100511	07/18/1997	NY	70.0	70		M	10/22/1996	pt recv vax & devel a fever of 99.9, nausea, muscle weakness & an inj site rxn @ the site of pnu-immun 23 characterized by redness, swelling, warmth, & pain;f/u 14JAN97 indicated pt also exp body aches & chills;tx w/advil & APAP & warm comp									Y	10/21/1996	10/21/1996	0		PVT	PVT	Inhaler;Tagamet	NONE	pagets disease, asthma, HTN, BPH, COPD, PUD & allergic rhinitis;	~ ()~~~In patient	896332008L	1						1	Chills; Injection site hypersensitivity; Injection site oedema; Injection site pain; Myasthenic syndrome; Nausea; Pyrexia; Vasodilatation; Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia; Myasthenic syndrome; Nausea; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4968170~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~433400~1~IM~RA~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~4968170~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~433400~1~IM~RA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0100512	07/18/1997	KY	46.0	46		F	11/19/1996	flu vax was inadvertently injected into pt shoulder joint;following day joint became swollen;the swelling was worsening @ the date of this report;f/u info recv 7JAN97 indicated pt also exp arthralgia w/loss of motion, strength & grip ;				Y					U	11/04/1996	11/04/1996	0		PUB	OTH	NONE	NONE	UNK	~ ()~~~In patient	896337004L	1						1	Arthralgia; Hypokinesia; Myasthenic syndrome; Osteoarthritis	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0100513	07/18/1997	AZ	36.0	36		F	11/13/1996	pt recv vax & devel h/a, fever, chills, & a rash on the arms & legs;sx resolved p/4 days;f/u info recv 14JAN97 indicated that the rash devel 2wk  post vax & resolved over 1 wk;pt remained recovered;									Y	10/21/1996	10/23/1996	2		PUB	OTH	NONE	NONE	allergic to sulfa drugs	~ ()~~~In patient	896337011L	1						1	Chills; Headache; Pyrexia; Rash	FLU3~PFIZER\WYETH~4968205~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0100373	07/21/1997	CA	39.0	39		M	07/03/1997	13NOV97 reduction in rheumatoid arthritis sx;17NOV96 lymph nodes (ax) swollen & painful both sides;27NOV96 MD notes hx of pain axillary area poss secondary to vax;									N	11/12/1996	11/13/1996	1	NONE	PUB	PUB	Motrin, Melatonin	NONE	rheumatoid arthritis	NONE~ ()~~~In patient	CA970058	1						1	Lymphadenopathy; Pain	FLU3~CONNAUGHT LABORATORIES~6F71212~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1391B~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0100397	07/21/1997	IN	64.0	64		F	07/12/1997	pt devel herpes zoster 19DEC96 & alleged that it is r/t recv flu vax 10OCT96;									N	10/10/1996	12/19/1996	70	NONE	PVT	PVT	Synthroid;Bufferin	Arthritis & hypothyroidism	PCN	~ ()~~~In patient		1						1	Herpes zoster	FLU3~PARKE-DAVIS~01066P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0100801	07/29/1997	WI	61.0			F	07/25/1997	pt devel visual loss in both eyes 3wk p/vax;4NOV93 noted blurring of both eyes rt > lt;BP 130/100;pupillary defect;visual field testing revealed upper nasal island of vision;optic disc swollen & peripapillary hem;allerg react;neuropathy;				Y	Y			Y	Y	10/15/1993	11/04/1993	20	The following tests were neg or nl: bilat temporal artery biopsy, MRI of brain & orbits w/ & w/o gadoliniu, lytes, BUN, creatine, alk phos, LDH, SOGT< GGT, SGTP, ESR< CBC, PT, PTT< lupus anticoagulant, Lyme titer, B-12, folate, flucose;	OTH	OTH	NONE	NONE	no history of ocular pain, cephalgia, jaw cladication, or preceding illness;NKA;no hx of cat bite, or exposure to cats;no family hx of impaired vision;	~ ()~~~In patient	010150970125000	1						1	Amblyopia; Eye disorder; Eye haemorrhage; Hypertension; Laboratory test abnormal; Neuropathy; Visual disturbance; Visual field defect	FLU3~PARKE-DAVIS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation,Disabling	Influenza
0086540	07/30/1997	LA	2.0	2	.8	F		pt recv vax 9OCT95 & 9OCT95 5hr p/vax pt exp fever 104;eyes rolled;was limp & was losing consciousness;taken to Er where was treated & released;pt recovered;				Y					Y	10/09/1995	10/09/1995	0	No relevant data;	PVT	PVT	Vantin	NONE		NONE~ ()~~~In patient	WAES96060313	1						3	Gaze palsy; Hypotonia; Pyrexia; Stupor; Gaze palsy; Hypotonia; Pyrexia; Stupor	FLU3~CONNAUGHT LABORATORIES~5F61082~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~1076E~1~IM~LA~PNEUMO (PNU-IMUNE)~2|FLU3~CONNAUGHT LABORATORIES~5F61032~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~0176E~1~IM~~PNEUMO (PNEUMOVAX)~3	USA	Emergency room visit	Influenza
0091531	07/30/1997	MO	70.0	70		F		pt recv vax 9OCT96 & same day exp fever redness & swelling around vax & chills;next day broke out w/little, tiny, red, hot raised, patchy bumps around the vax buttocks area;itching;viral synd;									Y	10/09/1996	10/09/1996	0	No relevant data;	OTH	OTH	Premarin;Cardizem CD;Diflunisall;vitamins;		bronchitis, chronic; Tuberculosis;	~ ()~~~In patient	WAES96101078B	1						2	Chills; Infection; Injection site hypersensitivity; Injection site oedema; Pruritus; Pyrexia; Rash maculo-papular; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0099386	07/30/1997	OK	78.0	78		F		pt recv vax 7NOV95 & 9NOV95 pt exp sl swelling & redness @ the inj site;pt recovered;									Y	11/07/1995	11/09/1995	2	No relevant data;	PVT	PVT		NONE	COPD & arthritis;	~ ()~~~In patient	WAES96061249	1						2	Injection site hypersensitivity; Injection site oedema; Injection site hypersensitivity; Injection site oedema	FLU3~PARKE-DAVIS~00675P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~394934~1~~RA~PNEUMO (PNEUMOVAX)~1|FLU3~PARKE-DAVIS~00675~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0100494	07/30/1997	NC	56.0	56		F		pt recv vax 3OCT96 & same the pt exp ear ache, sore throat, lethargy & h/a;									U	10/03/1996	10/03/1996	0	No relevant data;	OTH	OTH				~ ()~~~In patient	WAES96102636	1						2	Ear pain; Headache; Pharyngitis; Somnolence; Headache; Otitis media; Pharyngitis; Somnolence	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~~~PNEUMO (PNU-IMUNE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0101175	07/30/1997	MO	89.0			F		pt recv vax & NOV96 pt exp fever up to 102, fatigue, gen weakness, rash on upper & lower extremities & serum sickness;pt hosp for 1wk;					Y	7			U		11/01/1996		No relevant data;	OTH	OTH	APAP;Halcion			~ ()~~~In patient	WAES97011308	1						1	Asthenia; Pyrexia; Rash; Serum sickness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0101974	07/30/1997	TX	68.0	68		F		pt recv vax 16SEP96 & on 17SEP96 pt exp pain & erythema @ the inj site & a rash;									U	09/16/1996	09/17/1996	1	No relevant data;	OTH	OTH				~ ()~~~In patient	WAES96091538	1						1	Injection site hypersensitivity; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0101976	07/30/1997	TX	65.0	65		F		pt recv vax 29AUG96 & 31AUG96 pt exp a fever w/erythema & pain @ inj site;As of 18SEP96 pt was getting better;				Y					Y	08/29/1996	08/31/1996	2	ANA positive;	PVT	PVT		NONE	tremor;	~ ()~~~In patient	WAES96092429	1						1	Injection site hypersensitivity; Injection site pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0101987	07/30/1997	NJ	38.0	38		F		pt recv vax 15OCT96 & 2 days post vax pt devel a small red are @ inj site & a large 7x8cm raised erythema w/satellite vesicles around a huge wheal;also devel fever to 102;severe local rxn;									U	10/15/1996	10/17/1996	2	No relevant data;	PVT	OTH	Zoloft;Multiple vitamin	NONE		~ ()~~~In patient	WAES96101644	1						1	Injection site hypersensitivity; Injection site oedema; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71247~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0102028	07/30/1997	VA	79.0	79		M		pt recv vax 5DEC96 & pt exp pain & dec ROM in rt arm 30min p/vax;rt deltoid was tender around the inj site & warm to touch;the following morning pt devel a non-raised erythematous rash in the medial aspect of rt arm;tx w/tapering dose pred;				Y					Y	12/05/1996	12/05/1996	0	No relevant data;	PVT	PVT	ASA;Vitamin E;Ferrous sulfate;Darvocet-N 100;Prilosec;		MI;CABG;PUD;TIA: radiculopathy, lumbar;CAD;hemmorrhoids;constipation;	~ ()~~~In patient	WAES96120974	1						1	Hypokinesia; Injection site pain; Pain; Rash; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0846D~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0092371	08/19/1997	AK	30.0	30		F	10/04/1996	pt recv vax 2OCT96 1130AM & 2OCT96 10PM noticed itching on lt arm where flu vax given red hard-lump (small) & hives around inj site;lt deltoid bruised										10/02/1996	10/02/1996	0	NONE	OTH	PUB	NONE	NONE	NONE	~ ()~~~In patient	AK97001	1						2	Ecchymosis; Injection site hypersensitivity; Injection site mass; Pruritus; Urticaria	FLU3~PFIZER\WYETH~40849351~1~~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~MERCK & CO. INC.~1626B~1~~LL~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0101743	08/19/1997	AK	39.0	39		M	06/02/1997	reported fatigue/general malaise;non specific discomfort in knee, back & lower extremities;3wk p/vax 23OCT96;reported same sx 2-3 wk in 12OCT94									Y	10/23/1996	11/01/1996	9	NONE	OTH	PUB	NA	NONE	NONE	pt exp fatigue, malaise & discomfort w/flu vax 12OCT94;~ ()~~~In patient	AK97002	1						1	Arthralgia; Asthenia; Back pain; Malaise	FLU3~PFIZER\WYETH~~4~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0101745	08/19/1997	AK	45.0	45		F	11/07/1996	pt having a serious rxn to immun can barely move are;Friday Saturday couldn't move arm at all;rash to rt arm;pus pocket size of a dime;had fever x 2 days;referred MD;										10/31/1996	11/01/1996	1	NONE	UNK	UNK				~ ()~~~In patient	AK97003	1						1	Hypokinesia; Pyrexia; Rash	FLU3~PFIZER\WYETH~4968167~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1626D~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~6F81202~3~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0101752	08/19/1997	AK	39.0	39		F	01/09/1997	pt recv vax 6JAN97 & next lt arm hot & achy;1/8 entire arm sore & edematous;could not close fist;watch band left indentations;9JAN97 edema gone but joints in lt arm & hand sore;still sore & knuckles swollen;									N	01/06/1997	01/07/1997	1		PUB	PUB	PPD given 6JAN97;			~ ()~~~In patient	AK97006	1						1	Arthralgia; Myalgia; Myasthenic syndrome; Oedema peripheral; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4968167~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~6B81036~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0101828	08/25/1997	OH	45.0	45		F	08/06/1997	pt devel daily severe h/a (constant) 4 hr p/vax until present;pt was hosp for new onset of daily persistent h/a & put on preventative meds;pt has also exp gait difficulties since vax; (mild unsteadiness);				Y	Y	4			N	11/11/1996	11/11/1996	0	no evidence of significant CNS demyelination;r/o MS had spinal tap;MRI of brain;	OTH	PUB	Estrace	no illness	NONE	NA~ ()~~~In patient		1						1	Coordination abnormal; Gait disturbance; Headache; Myalgia	FLUX~UNKNOWN MANUFACTURER~~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0101923	08/28/1997	SC	55.0	55		F	06/07/1997	pt devel fever, had aching & felt warm;pt got too chilled in freezing weather;had some rash;devel arthritis from sacroiliac on down whole rt leg;had some trouble there for a month;took OTC drugs for arthritis;									Y	11/15/1996	11/17/1996	2	NONE	PUB	PVT	Premarin	NONE	allergic to drugs, melaril & valium;	~ ()~~~In patient		1						1	Arthritis; Chills; Myalgia; Pyrexia; Rash; Vasodilatation	FLU3~PARKE-DAVIS~0986P~1~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TTOX~CONNAUGHT LABORATORIES~6B81036~2~~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0080091	09/05/1997	MA	54.0	54		F	11/29/1995	pt recv vax & devel facial nerve palsy;no other details were known @ the time of this report;				Y					N	11/20/1995	11/21/1995	1		PUB	OTH	Beconase;Provera;Estrace;Propulsid;Zantac;Advil;Drixoral;	NONE	Gastroesophageal reflux;perennial non-allergic rhinitis;NKA;	~ ()~~~In patient	896011006L	1						2	Facial palsy	FLU3~PFIZER\WYETH~4958116~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~428504~1~IM~RA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0102181	09/05/1997	VA				F	05/16/1997	1 days p/vax pt devel Bell's Palsy;As of 7MAY97 pt still exp facial paralysis, lt eye watered & would not close & had diff chewing & eating;no further info was available @ the date of this report;				Y				Y	N	11/04/1996	11/05/1996	1		OTH	OTH	unk	unk		~ ()~~~In patient	897141003L	1						1	Dysphagia; Eye disorder; Facial palsy; Lacrimal disorder	FLU3~PFIZER\WYETH~4968201~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0102182	09/05/1997	IA	13.0	13		M	04/24/1997	20min p/vax pt devel hives on stomach, back, arms & legs;pt had no diff breathing;the hives resolved w/in 1hr;									Y	10/18/1996	10/18/1996	0		PVT	OTH	Allergy shots	NONE	allergic to dust mites & dogs;	~ ()~~~In patient	897143007L	1						1	Urticaria	FLU3~PFIZER\WYETH~4968192~4~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0102183	09/05/1997	PA	54.0	54		F	06/13/1997	pt recv vax 26SEP96 & pt began exp coldness & burning sensations in lower extremities;bone scan, EMS, MRI & neuro rheumatological consults have been found to be unrevealing of the etiology of sx;sx persisted as of 13MAR97;				Y					U	09/26/1996	11/20/1996	55	Bone scan, EMG, MRI: unrevealing;	PVT	OTH	VALIUM	NONE		~ ()~~~In patient	897188011L	1						1	Chills; Hypoaesthesia; Pain; Peripheral vascular disorder	FLU3~PFIZER\WYETH~4968170~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0102184	09/05/1997	NY				U	06/19/1997	pt recv vax in OCT94 & allegedly devel shingles some time later;this report was recv as part of legal proceedings involving the MD;									U	10/01/1994				OTH	OTH	UNK	UNK		~ ()~~~In patient	897195029L	1						1	Herpes zoster; Infection	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0102703	09/05/1997	CT				U	11/12/1996	pt recv vax devel myositis;No further info was available @ the date of this report;f/u info was recv 13JUN97;									U					OTH	OTH	unk	unk		~ ()~~~In patient	896325007L	1						1	Myositis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0102704	09/05/1997	MA	37.0			F	11/12/1996	approx 10min p/vax pt exp the sensation of an electrical wave from lt deltoid down to foot;this was followed by numbness & tingling in lt leg;									Y	11/12/1996	11/12/1996	0		PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient	896324022L	1						1	Paraesthesia	FLU3~PFIZER\WYETH~4968206~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0079771	09/10/1997	IL	66.0	66		F	08/12/1996	pt recv vax 16OCT95 & 2wk later pt devel face & jaw swelled to the point of disfigurement;pt became depressed & withdrawn & has been treated unsuccessfully w/an antidepressant;dx infect in blood;cont to exp urticaria;				Y					N	10/16/1995	10/30/1995	14		OTH	OTH	Synthroid;Hydralazine;	NONE		~ ()~~~In patient	896235014L	1						3	Depression; Face oedema; Infection; Personality disorder; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~3|PPV~PFIZER\WYETH~~1~IM~~PNEUMO (PNU-IMUNE)~3	USA	Emergency room visit	Influenza
0091695	09/10/1997	WA	52.0	52		F	06/25/1996	pt recv vax & exp urticaria & swelling of the lips & eyes;pt cont to exp urticaria as of the date of this report;r/u info recv 6AUG96 indicated that pt also exp arm pain;pt recovered;				Y					Y	12/08/1995	12/09/1995	1	positive immed hypersensitivity skin test to vax;	OTH	OTH	unk	NONE	PCN allergy, arthritis, chronic sinusitis, probable MS;	pt recv flu vax for 10yrs w/o adverse exp;~ ()~~~In patient	896183012L	1						2	Face oedema; Pain; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0095692	09/10/1997	MO	53.0	53		F	12/02/1996	pt recv vax & devel neuropathy;1wk post vax pt exp arthralgia & numbness @ the inj site which radiated down arm (affected arms, as well as sites of vax administration, unspecified);pt has recovered;									Y	09/30/1996				OTH	OTH	ASA;Calcium carbonate;Multivitamin;	chronic cough-etiolog unk	NKA;mitral valve prolapse;	~ ()~~~In patient	897077001L	1						2	Arthralgia; Injection site reaction; Neuropathy; Paraesthesia; Arthralgia; Neuropathy; Paraesthesia	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~1~IM~~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~~1~IM~~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0095776	09/10/1997	CA	59.0	59		F	11/04/1996	pt recv vax 31OCT96 & had recv same vax approx 10mo prior to the 31OCT96 dose;31OCT96 pt devel redness & warmth @ inj site;4NOV96 devel fever, h/a, disorientation & dizziness x 3 days;exp lt sided back pain & arthralgia;diff walking									U	10/31/1996	11/01/1996	1		PVT	PVT	Synthroid;ASA;	NONE	hypothyroidism, pulmonary embolism;	~ ()~~~In patient	896318001L	1						2	Confusional state; Gait disturbance; Headache; Hypokinesia; Injection site oedema; Pain; Renal pain; Arthralgia; Back pain; Confusional state; Dizziness; Gait disturbance; Injection site hypersensitivity; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~~2~IM~LA~PNEUMO (PNU-IMUNE)~1|FLU3~CONNAUGHT LABORATORIES~6F71247~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~431803~2~IM~LA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0100511	09/10/1997	NY	70.0	70		M	10/22/1996	pt recv vax & devel a fever of 99.9, nausea, muscle weakness, body aches, chills & inj site rxn @ the site of vax characterized by redness, swelling, warmth, & pain;tx w/Advil, APAP & warm compresses to the site of vax;recovered;									Y	10/21/1996	10/21/1996	0		PVT	PVT	inhaler;Tagamet;	NONE	Paget's Disease, asthma, HTN, BPH, COPD, PUD & allergic rhinitis;	~ ()~~~In patient	896305004L	1						2	Chills; Injection site hypersensitivity; Injection site oedema; Injection site pain; Myasthenic syndrome; Nausea; Pyrexia; Vasodilatation; Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia; Myasthenic syndrome; Nausea; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4968170~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~433400~1~IM~RA~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~4968170~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~433400~1~IM~RA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0102376	09/10/1997	WY	65.0	65		F	10/11/1996	3hr p/vax pt devel an inj site rxn characterized by redness, warmth, & swelling which extended below the elbow;pt was treated w/DPH & ice & was recovered @ the date of this report;									Y	09/30/1996	09/30/1996	0		PVT	PVT	unk	NONE	diabetic-non isnulin dependent	~ ()~~~In patient	896285032L	1						1	Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Vasodilatation	FLU3~PFIZER\WYETH~4968143~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~433400~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0102377	09/10/1997	WY	69.0	69		M	10/11/1996	3hr p/vax pt devel an inj site rxn characterized by redness, warmth, & swelling which extended below the elbow;pt treated w/DPH & ice & was recovered @ date of this report;									Y	09/30/1996	09/30/1996	0		PVT	PVT	unk	NONE	diabetic-insulin dependent;	~ ()~~~In patient	896285033L	1						1	Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Vasodilatation	FLU3~PFIZER\WYETH~4968143~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~433400~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0102383	09/10/1997	IA	32.0	32		F	10/15/1996	pt devel erythema & induration the size of a baseball @ the site of vax;pt was treated w/DPH;									U	10/14/1996	10/14/1996	0		PVT	PVT	Nasacort;Theophylline;	NONE		~ ()~~~In patient	896296017L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~436121~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0102384	09/10/1997	IA	72.0	72		M	10/15/1996	w/in 1hr of vax pt devel erythema & induration @ the site of vax;									U	10/14/1996	10/14/1996	0		PVT	PVT	Notriptyline;ASA;	NONE		~ ()~~~In patient	896296018L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~436121~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0102387	09/10/1997	FL	85.0	85		M	10/23/1996	pt recv vax & exp intense pain of the back, neck, & rt arm;the day following vax pt was unable to move rt shoulder;upon the advice of MD took DPH & advil;									Y	10/22/1996	10/22/1996	0		PVT	PVT	Lanoxin;	NONE	NKA	~ ()~~~In patient	896305009L	1						1	Back pain; Hypokinesia; Neck pain; Pain	FLU3~CONNAUGHT LABORATORIES~6F71278~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~438134~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0102389	09/10/1997	OH	36.0			M	10/28/1996	pt recv vax & the next evening pt devel chills, fever of 102.5, redness @ the Pnu-Imune 23 inj site w/red streaks radiating to the inner arm & axilla & lt axillary;lymphadenopathy;2 days p/vax MD dx secondary infect;									Y	10/24/1996	10/25/1996	1		PVT	PVT	unspecified asthma medication;	NONE	asthma;	~ ()~~~In patient	896311016L	1						1	Chills; Infection; Injection site hypersensitivity; Lymphadenopathy; Pyrexia; Skin striae	FLU3~CONNAUGHT LABORATORIES~~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~438670~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0102390	09/10/1997	CA	32.0	32		F	11/01/1996	pt recv vax & that evening pt devel swelling, redness, & tenderness @ the site of vax;2 days later pt entire left arm was swollen to twice its normal size, red & tender;26SEP96 pt dx w/pneumonia;				Y					U	10/28/1996	10/28/1996	0		PVT	PVT	Pondimin;Phentermine	NONE		~ ()~~~In patient	896312002L	1						1	Infection; Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Pain; Pneumonia; Vasodilatation	FLU3~PFIZER\WYETH~4968143~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~431805~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0102391	09/10/1997	MI	6.0	6		M	10/30/1996	1 day p/vax pt devel a fever of 103 & a 5inch by 3 inch area of redness @ the site of vax;4 days post vax pt devel swelling @ vax inj site which extended below the elbow;the swollen area was also red & squishy;tx w/APAP, Pediapred & Lorabid				Y					Y	10/26/1996	10/27/1996	1		PVT	PVT	Intal neublizer;Proventil inhaler;Proventil Neublizer;Rynatan liquid;	allergic otitis	bronchial asthma;allergic rhinitis;allergic otitis;	~ ()~~~In patient	896313008L	1						1	Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Pyrexia; Vasodilatation	FLU3~PARKE-DAVIS~00576P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0102395	09/10/1997	KY	49.0	49		F	11/08/1996	2 days p/vax pt devel an inj site rxn characterized by redness & swelling the size of a grapefruit;pt also devel red streaks extending toward the lt groin, lymphadenopathy;				Y					Y	11/05/1996	11/07/1996	2		PVT	OTH	Atrovent;Calcium;Cardizem CD;Codeine;K-TABs;Nicotinic ACID;ORUDIS;PREMPRO;TENORMIN;VICODIN;ZANTAC;	NONE		~ ()~~~In patient	896318018L	1						1	Injection site hypersensitivity; Injection site oedema; Lymphadenopathy; Skin striae	FLU3~CONNAUGHT LABORATORIES~6F71248~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~431805~2~IM~LL~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0102398	09/10/1997	IA	46.0			F	10/25/1996	1hr p/vax pt devel redness @ the inj site, swelling @ the inj site which extended to the elbow, stiffness w/an inability to lift arm, & vomiting;									U	10/14/1996	10/14/1996	0		PVT	PVT	Lotensin;Glucotrol XC;Prempro;Glucophage;	UNK	diabetes mellitus, type II	~ ()~~~In patient	896323011L	1						1	Hypertonia; Hypokinesia; Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Vomiting	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~433402~1~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0102401	09/10/1997	WA	74.0	74		M	11/11/1996	pt recv vax & over the next 3 days pt devel an inj site rxn @ the site of vax;pain in the right arm, shoulder & chest;fever of 101 to 101.6;chills;& a rash like measles on chest;									Y	11/06/1996	11/07/1996	1		OTH	PUB	HCTZ	unk		~ ()~~~In patient	896325008L	1						1	Arthralgia; Chest pain; Chills; Injection site reaction; Pain; Pyrexia; Rash maculo-papular	FLU3~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0102410	09/10/1997	AL	6.0	6		F		4 days p/vax pt devel an inj site rxn characterized by redness & swelling @ the site of vax;tx w/hot & cold compresses, DPH & advil;									Y	11/01/1996	11/05/1996	4		PVT	PVT	NONE	unk		~ ()~~~In patient	896351021L	1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~4968140~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~436134~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0102411	09/10/1997	AL	6.0	6		M	11/01/1996	3 days p/vax pt devel an inj site rxn  characterized by a 2-inch area of redness, swelling, & hardness @ site of vax;tx w/hot & cold compresses, DPH & advil;									Y	11/01/1996	11/04/1996	3		PVT	PVT	unk	unk		~ ()~~~In patient	896320011L	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~PFIZER\WYETH~4968140~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~436134~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0102425	09/10/1997	KS	38.0	38		M	12/19/1996	pt recv vax & devel an angry appearing red rash @ the inj site;pt was seen by MD  who dx cellulitis;				Y					Y	11/01/1996	11/02/1996	1		PVT	PVT	unk	none		~ ()~~~In patient	896361012L	1						1	Cellulitis; Injection site hypersensitivity; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~436822~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0102426	09/10/1997	KS	33.0	33		F	12/19/1996	pt recv vax & devel an angry appearing red rash @ the inj site;									Y	11/01/1996	11/04/1996	3		PVT	PVT	unk	none		~ ()~~~In patient	896361013L	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~436822~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0102428	09/10/1997	OH	28.0	28		M	01/07/1997	2 days p/vax pt devel cellulitis @ the site of vax;pt was treated w/duricef & pred & recovered;									Y	11/18/1996	11/20/1996	2		PVT	PVT	Lodine;Pepcid	NONE		~ ()~~~In patient	897070007L	1						1	Cellulitis; Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~~UNK~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0102429	09/10/1997	IN	66.0	66		F	02/02/1997	pt recv vax & next day devel an inj site rxn characterized by swelling & pain;then devel urticaria & lymphadenitis, described as a red streak from the shoulder to the axilla & lymph node tenderness;pt recovered;									Y	01/30/1997	01/31/1997	1		OTH	PVT	NONE	unk		~ ()~~~In patient	897076019L	1						1	Injection site oedema; Injection site pain; Lymphadenopathy; Skin striae; Urticaria	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0102432	09/10/1997	AZ	48.0	47		F	01/27/1997	2 or 3 days p/vax pt devel pain @ the site of vax;pt then exp pain in rt arm & shoulder w/diff lifting arm;self medicated w/Ibuprofen & muscle relaxants;seen by MD who dx bursitis secondary to IM administration of vax;				Y					U	01/10/1997	01/13/1997	3		PUB	PUB	NONE	unk		~ ()~~~In patient	897077003L	1						1	Arthralgia; Bursitis; Hypokinesia; Injection site pain; Pain	FLU3~PFIZER\WYETH~4968167~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~428495~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0102464	09/10/1997	PA				F	08/20/1997	pt recv vax & shortly afterward exp flu-like sx which recur periodically;pt has been dx w/metastatic ovarian cancer which believes  was caused by swine flu vax;			Y	Y					N					OTH	OTH	UNK	UNK		~ ()~~~In patient	897233004L	1						1	Influenza; Neoplasm malignant	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0102680	09/22/1997	NY	52.0	52		F	09/09/1997	evening of vax muscle & joint pain, limping, affected sleep, serum sickness, allergic reaction;									Y	11/26/1996	11/26/1996	0		OTH	OTH				~ ()~~~In patient		1						1	Arthralgia; Bursitis; Calcium metabolism disorder; Chest pain; Gait disturbance; Gastric ulcer; Myalgia; Serum sickness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0102708	09/26/1997	CO	40.0	40		F	09/24/1997	demyelinating peripheral neuropathy-both hands, both feet-misdiagnosed prev as arthritis;				Y	Y	5		Y	Y	10/01/1996	11/02/1996	32	LP, MRI, Biopsy	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Arthritis; Neuropathy	FLUX~UNKNOWN MANUFACTURER~~7+~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0102894	09/26/1997	PA	25.0	25		F	06/30/1997	immed tingling sensation in rt hand to inj site & then into ear;skin temp variation between hands;									Y	01/19/1996	01/19/1996	0		PVT	PVT	Hormones	NONE	no past hx;	NONE~ ()~~~In patient	CO6446	1						1	Paraesthesia; Peripheral vascular disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEA~MERCK & CO. INC.~~UNK~~~MEASLES (NO BRAND NAME)~1|TYP~CONNAUGHT LABORATORIES~L03000~1~~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0102776	09/29/1997	CO	68.0	68		F	09/09/1997	pt recv vax in OCT93 & in FEB94 pt exp loss of taste & smell;CT scans & MRI were reportedly neg;pt stated that a specialist told her has olfactory nerve damage r/t flu shot;								Y	N	10/01/1993	02/01/1994	123	CT scans: reportedly negative;MRI's reportedly negative;	PVT	OTH	NONE	NONE	recurrent facial shingles isnce 1945 which was treated w/x-ray therapy in 1945;	~ ()~~~In patient	897255006L	1						1	Ageusia; Neuropathy; Parosmia	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0102782	09/29/1997	AZ	46.0			F	02/03/1997	felt achy for 2wk became worse w/muscle aches, denied a fever, denied SOB;viral synd devel secondary;bronchitis;									Y					PUB	UNK		NONE		~ ()~~~In patient		1						1	Bronchitis; Myalgia	FLU3~PFIZER\WYETH~4968177~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0102801	09/29/1997	IA	56.0	56		F	09/19/1997	sl redness @ inj site about 48hr-itchy;									Y	09/17/1997	09/17/1997	0	NA	PVT	PVT	HCTZ;Quinamm;Ibuporfen;vit C;Estrace:provera;Vit b-6;Nacin;Diflucan;K20;Calcium w/vit;Iron Dexrran;	NONE	unk	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81740~7+~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0102802	09/29/1997	IA	59.0	59		F	09/19/1997	small local rxn-redness & itch area about 2-3cm in diameter;recovered p/48hr;									Y	09/17/1997	09/17/1997	0	NA	PVT	PVT	Paxil;Lanox varies to need;Lasix PRN;	NONE	fluid retention-obsessive complaince;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81740~7+~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0102832	10/01/1997	PA	59.0	59		M	09/30/1997	pt recv vax 26SEP97 & 29SEP97 reported onset of episode stomach cramping 27SEP97 AM w/1 episode of vomiting;denied diarrhea, fever, chills, states cramp sensation is now subsiding;										09/26/1997	09/27/1997	1	NONE	OTH	OTH		stomach cramping;	NONE	unk~ ()~~~In patient		1						1	Abdominal pain; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81869~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0102893	10/02/1997	CO	45.0	45		F	10/01/1997	anaphylaxis;vitals t98.3, P84, R16;BP 110/60;SOB;throat swelling;itch whole body;tx solumedrol;				Y					Y	10/01/1997	10/01/1997	0		OTH	OTH	NONE	NONE	allergic to pollen poss PCN;	~ ()~~~In patient		1						1	Anaphylactoid reaction; Dyspnoea; Hypotension; Hypoventilation; Laryngospasm; Pruritus; Asthenia; Dizziness; Ear disorder; Laryngospasm; Nausea; Pharyngitis; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81862~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7F81862~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0102938	10/06/1997	IN	15.0			F	10/03/1997	unresponsive w/apparent sz-incontinent unconscious jaw clamped shut-unresponsive to name ash color;			Y	Y	Y				U	10/01/1997	10/01/1997	0	unk	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Convulsion; Hypertonia; Pallor; Stupor; Syncope; Urinary incontinence	FLU3~CONNAUGHT LABORATORIES~7F81788~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0102941	10/06/1997		59.0	59		M	10/06/1997	pt recv vax & became very ill;devel flu sx, weak, tired, lethargic, felt rotten;sx worsened over the next couple of months;hosp DEC or JAN for unspecified period of time;IV fluids;loss 35lbs;dx addison disease JUL97;					Y				N	09/01/1996	09/01/1996	0	NONE	OTH	OTH		immun against influenza;	NONE	~ ()~~~In patient	MPI97718	1						1	Adrenal insufficiency; Asthenia; Dehydration; Influenza; Malaise; Somnolence; Weight decreased	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0102953	10/06/1997	MD	73.0	73		M	10/01/1997	rt bicep extremely painful & red;									Y	09/28/1997	09/30/1997	2		PVT	UNK		NONE		NONE~ ()~~~In patient		1						1	Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81895~6~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0102958	10/06/1997	OH	55.0	55		M	10/02/1997	pt was itching on bilat arms & devel welts around waistline area & upper lip swollen then next AM rx DPH									Y	09/30/1997	09/30/1997	0		PVT	OTH	Ticlid;Toprol	NONE		~ ()~~~In patient		1						1	Face oedema; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~BD004~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0102995	10/07/1997	CA	74.0	74		F	10/01/1997	24SEP sore throat, sl temp, runny nose, aches & watery eyes, sleepy;25SEp temp, sleepy, no appetite & soreness all over;rest of week no appetite, phlegm & cough;MD visit on 29SEP97 lung clear;still coughing;									Y	09/23/1997	09/24/1997	1		OTH	UNK	vitamins	NONE	NONE	~ ()~~~In patient		1						1	Anorexia; Cough; Lacrimal disorder; Myalgia; Pharyngitis; Pyrexia; Rhinitis; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0103006	10/07/1997	MS	43.0			F	10/01/1997	light-headedness, tremulous, palpitations, cold sweat about 10min post inj;lasted about 5min;									Y	10/01/1997	10/01/1997	0	BP 124/78;P85;t98;	PUB	PUB		NONE	mult environmental allergies;	~ ()~~~In patient		1						1	Chills; Dizziness; Hyperhidrosis; Palpitations	FLU3~PFIZER\WYETH~4978181~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0103023	10/07/1997	AZ	36.0	36		F	10/24/1996	total body flushing, joint aches, pedal edema, nausea started on 19OCT approx 48hr p/still prominent 1wk later;took advil, cold showers used cortaid ointment;also had total body itching-no hives, no diarrhea;									N	10/17/1996	10/19/1996	2		PVT	UNK	NONE	NONE	asthma, CFS	~ ()~~~In patient		1						1	Arthralgia; Oedema peripheral; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0103030	10/08/1997	CA	90.0			M	10/02/1997	pt recv vax 330PM & devel syncope approx 1hr later @ home;					Y					10/01/1997	10/01/1997	0		UNK	UNK	CA cocoa;Bifaculos heart block;Ca prototo		allergic PCN/ASA;	~ ()~~~In patient		1						1	Syncope	FLU3~CONNAUGHT LABORATORIES~7S81753~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0103034	10/08/1997	WV	7.0	7		F	10/06/1997	gen rash all over body started approx 2hr post vax;				Y					Y	10/03/1997	10/03/1997	0	NONE	PVT	PVT	NONE	NONE	allergic to polymox	~ ()~~~In patient		1						1	Rash	FLU3~CONNAUGHT LABORATORIES~7F81860~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0103035	10/08/1997					U		pt recv vax 22OCT96 & pt felt like was getting a rxn & lips felt funny;appeared very flushed;pt laid down;VS 147/88-96-18;no SOB;knot @ inj site;									Y	10/22/1996	10/22/1996	0	VS 147/88-96-18 upon d/c approx 1 1/2hr later 131/79-84-12;	UNK	UNK	Elavil, DPH, Synthroid, Premarin, Oxycodone, Prozac, MV, Colace, Senoke;		pancreatic cA no allergy documented & pt denied allerty to eggs;	~ ()~~~In patient		1						1	Injection site mass; Paraesthesia oral; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~IM~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~IM~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0103038	10/08/1997	CA	69.0	69		M	10/01/1997	redness on arm distal to inj site @ 2D past inject;pt says rt arm was pneumococcal vax MD records show rt arm flu shot;										09/23/1997	09/25/1997	2	NONE	UNK	UNK	Covera			~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~7F81741~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0845D~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0103042	10/08/1997	PA	44.0	44		F	09/26/1997	pt shows localized edema redness @ inj site plus swollen eyes, all over body itching, some ankle swelling;poss allerg rxn or drug interaction;										09/24/1997	09/26/1997	2		UNK	UNK	Diovan, Lipitor, Erythromycin, Premarin, Percocet, Voltaren;		smoker	~ ()~~~In patient		1						1	Face oedema; Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Pruritus	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0103060	10/09/1997	FL	22.0	22		F	10/02/1997	felt itchy all over 10min p/vax;then had diff breathing-felt as if throat was closing-20min later taken to ER-given DPH;dx allerg react;				Y					Y	10/01/1997	10/01/1997	0	NA	OTH	PVT	NA	NA	NA	NA~ ()~~~In patient		1						1	Dyspnoea; Hypersensitivity; Laryngospasm; Pruritus	FLU3~PFIZER\WYETH~4978173~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0103064	10/09/1997	MD	71.0	71		F	10/06/1997	pt recv vax 4OCT97 lt deltoid & devel large, red, inflamed area lt humerus 5 1/2 long x 4 wide;advised ice, DPH PRN & f/u if sx worsen;									Y	10/04/1997	10/05/1997	1	NA	PVT	UNK			allergy codeine, compazine;hx FCBD, hyperlipidemia, chronic cough;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site inflammation; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~7F81895~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~435963~UNK~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0103065	10/09/1997	IN	5.0	5		F		diffuse urticaria & throat swollen w/in 4hr of flu shot;									Y	10/01/1997	10/01/1997	0		PVT	PVT		NONE	drug allergies:ceclor, vantin, cleocin, lorabid, augmentin;	~ ()~~~In patient		1						1	Laryngospasm; Urticaria	FLU3~PFIZER\WYETH~4978196~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0103089	10/14/1997	IL	67.0	67		F		pt started vomiting, devel chills & became red on neck & upper chest;									Y	10/09/1997	10/09/1997	0	anaphylactic rxn to vax;	PUB	UNK	Amaryl		allergy to Monopril;non insslin dependent diabetes mellitus;	~ ()~~~In patient		1						1	Anaphylactoid reaction; Chills; Vasodilatation; Vomiting	FLU3~PFIZER\WYETH~4978168~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0103090	10/14/1997	MD	49.0	48		F	10/13/1997	arm, red 2 circle around site;hurt, hot, itchy x 3 days;									Y	10/09/1997	10/10/1997	1	NONE	OTH	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0103093	10/14/1997	MN	45.0	45		F	10/13/1997	forced air inj-jumped to one side-nervous rxn-bruise, 2 purple red raised center move arm;									Y	10/11/1997	10/12/1997	1	unk	OTH	PUB	Insulin	NONE	diabetic	~ ()~~~In patient		1						1	Agitation; Ecchymosis; Hypokinesia; Injection site hypersensitivity; Injection site oedema; Skin discolouration	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0103094	10/14/1997	NV	71.0	71		F	10/14/1997	pt exp severe pain, rt shoulder & rt collar bone drove to hosp, 8:30PM fainted, during evening fainted two more times;in bed every since;now has transitory pain in abd, rib cage;eating less, lost 4lbs;red cheeks & ears;									N	10/10/1997	10/10/1997	0		UNK	UNK			lowblood sugar, takes 1/4-1/2dose of anesthetic, etc;weakness of muscles since 1995 rxn to flu shot	pt exp muscular weakness w/flu vax;~ ()~~~In patient		1						1	Abdominal pain; Anorexia; Dehydration; Injection site haemorrhage; Pain; Syncope; Vasodilatation; Weight decreased	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0103095	10/14/1997	CA	71.0	70		F	10/10/1997	vomit, diarrhea, cont through day-feels completely out of it;									N	10/08/1997	10/10/1997	2	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	CA970091	1						1	Asthenia; Diarrhoea; Malaise; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81841~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103096	10/14/1997	IL	46.0			M	10/13/1997	fever, aches, tightness in chest, dizziness, over all bad feeling, heaviness in head;									N		10/10/1997		NONE	PUB	PUB						1						1	Chest pain; Dizziness; Malaise; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0103097	10/14/1997	WI	50.0	50		F	10/10/1997	1/2hr post vax pt exp hives-upper extremities;				Y					Y	10/09/1997	10/09/1997	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0103098	10/14/1997	NJ	51.0	51		M	10/13/1997	aches in joints & muscle area x 3 days w/temp 99-101 consistent 100 temp x 3 days;									Y	10/10/1997	10/10/1997	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	NJ9736	1						1	Arthralgia; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0103100	10/14/1997	NY	66.0	66		F	10/07/1997	pt recv vax 3OCT97 p/1PM on Saturday had redness on arm-5OCT97 itching, redness & 3-4blisters @ inj site;coughing & rhinitis, sneezing;6OCT97 blisters happened red area oblong in sharp-blisters drying up;feels better now;									Y	10/03/1997	10/04/1997	1		PUB	PUB			HTN on premarin;allergic dust, mold, grass & leaves;	pt exp rxn 1975 w/flu vax;~ ()~~~In patient	NY97046	1						1	Cough; Dermatitis bullous; Injection site hypersensitivity; Myalgia; Pruritus; Rhinitis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81798~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103102	10/14/1997	FL				F	10/13/1997	pt recv vax 9OCT97 pt had t100 instructed to take APAP;called back Monday AM to state was sick all weekend w/flu type sx but now rt arm pneumonia site is swollen & reddened from elbow to shoulder;									Y	10/09/1997	10/10/1997	1		OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Influenza; Injection site hypersensitivity; Injection site oedema; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F8189~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~442520~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0103115	10/14/1997	VA	34.0	34		F	10/10/1997	allerg rxn to vax-redness @ site, sore joints through the 1st day;it disappeared;the next day 4PM became very sick, weak legs, unable to work;rx DPH, pred, fluids;seen by MD;				Y					Y	10/07/1997	10/09/1997	2	NA	OTH	PVT		NONE	pt has recently devel mult allergies;had flu vax last 4yr w/o diff;	~ ()~~~In patient		1						1	Arthralgia; Hypersensitivity; Hypokinesia; Injection site hypersensitivity; Malaise; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~7F81819~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0103117	10/14/1997	AK	60.0	60		F	10/02/1997	lt arm had red streaks, hot to touch, painful into shoulder;pt have fever, chills;				Y					N	09/30/1997	10/01/1997	1	NONE	PVT	PVT	NONE	unk	hypothyroid or replacement	~ ()~~~In patient		1						1	Chills; Pain; Pyrexia; Skin striae; Vasodilatation	FLU3~PFIZER\WYETH~4978156~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0906E~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0103128	10/14/1997	PA				F	10/07/1997	36 to 48hr p/vax devel sx of intense myalgias specially @ abd region & also noted RUQ pains & mult ecchymotic lesions thighs, buttocks, legs w/localized soreness;no fever;									U				Pt, Ptt, plat ordered & all WNL;	OTH	PUB	Mevacor ??	NONE	inc cholesterol (takes Mevacor);	NA~ ()~~~In patient		1						1	Abdominal pain; Ecchymosis; Injection site pain; Myalgia	FLU3~PFIZER\WYETH~4978167~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0103135	10/14/1997	NJ	71.0	71		F	10/08/1997	rt arm upper inner aspect +erythema, +warmth non-tender;negative induration;10cm x 5cm area;negative upper arm edema;									U	10/06/1997				PVT	UNK	Allegra, Vancenase AQ, Prozac, Cardizem, Ceftin	NONE	erythromycin-GI upset	~ ()~~~In patient		1						1	Rash; Vasodilatation	FLU3~PFIZER\WYETH~4978162~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~438672~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0103136	10/14/1997	NJ	75.0	75		F	10/08/1997	pt reports erythema & swelling & pain @ site of inj;										10/07/1997				PVT	UNK	Claritin;Serpas			~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4978162~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~438672~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0103146	10/15/1997	IN	15.0			F	10/10/1997	pt recv vax 1OCT97 & w/in 2min of vax pt exp a sz (jaw tight, eyes rolled back, ashen colored, incontinent) for a duration of approx 2min;@ 5min p/vax pt became conscious & aware of name;pt taken to ER & reported vomited;hosp 2 days				Y	Y	2			Y	10/01/1997	10/01/1997	0		UNK	UNK				~ ()~~~In patient	CO7540	1						1	Convulsion; Gaze palsy; Hypertonia; Pallor; Urinary incontinence; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F1788~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0103175	10/15/1997	WI	23.0	22		F	10/06/1997	presented 20min p/vax c/o itching & erythema @ inj site;seen in MD office dx acute allergic rxn;erythema & itching radiated to lt lateral neck & c/o fullness in throat;tx w/epi & DPH & solu-medrol;				Y					Y	10/06/1997	10/06/1997	0	NONE	PVT	PVT	Levsinex;Birth control	irritable bowel synd	environmental allergies/cantalope;	pt devel erythema, edema & warm @ inj site w/varivax dose 1;~ ()~~~In patient		1						1	Hypersensitivity; Injection site hypersensitivity; Laryngospasm; Pruritus; Rash	FLU3~PFIZER\WYETH~4978140~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0103176	10/15/1997	NJ	40.0	40		F	10/10/1997	pt c/o tingling in bilat hands, dizziness & c/o nausea;pt laid safely on floor & states wants to lay down in case faints;pt given epi immed;pt pulse down from 130bpm p/5min to 90 bpm;pt given 02p;				Y					Y	10/10/1997	10/10/1997	0		OTH	PVT		NONE	shellfish	~ ()~~~In patient		1						1	Dizziness; Hypoxia; Nausea; Paraesthesia; Tachycardia	FLU3~CONNAUGHT LABORATORIES~7F81883~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0103177	10/15/1997	MN	24.0	24		F	10/08/1997	around 1PM felt a tightness in throat, SOB & began coughing w/diaphoresis;went to ETU because was @ hosp & wanted MD eval;given DPH w/relief;MD did not feel it was anaphylaxis @ all;VS stable throughout;				Y					Y	10/06/1997	10/06/1997	0		PVT	PVT	unk	NONE	unk	~ ()~~~In patient		1						1	Cough; Dyspnoea; Hyperhidrosis; Laryngospasm	FLU3~CONNAUGHT LABORATORIES~7181790~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0103179	10/15/1997	IL	17.0	17		F	10/09/1997	throat was tight, out of breath, sweating, 15-20 min p/inj;				Y					Y	10/07/1997	10/07/1997	0	NONE	PUB	PVT	Prozac;Claritan;	NONE	pollen, dust	pt devel sl swelling & soreness w/childhood vax;~ ()~~~In patient		1						1	Dyspnoea; Hyperhidrosis; Laryngospasm	FLU3~CONNAUGHT LABORATORIES~7F81852~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0103181	10/15/1997	IN	49.0	49		F	09/30/1997	immed redness of lt deltoid around inj site;progressed to 3 area around site;also dizzy & some drainage in back of throat;area was warm & tender to touch;				Y					Y	09/30/1997	09/30/1997	0	DNA	OTH	PUB	estrogen;becanase nasal spray	NONE	seasonal allergies;	unk~ ()~~~In patient		1						1	Dizziness; Injection site hypersensitivity; Injection site pain; Rhinitis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81857~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0103183	10/15/1997	RI	4.0	4		F	10/03/1997	30SEP97 pt recv vax & 1OCT97 devel fever 3PM w/flu like sx;4OCT97 fever inc 102-105-seen by MD rx APAP/advil;3OCT97 mom report to hlth dept;				Y					Y	09/30/1997	10/01/1997	1		PVT	UNK	NONE	NONE	eczema	~ ()~~~In patient		1						1	Influenza; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81741~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0103184	10/15/1997	TX	40.0			F	10/09/1997	vaccine site rt deltoid redness w/inc itching-area about size of half dollar-ice applied;				Y					Y	10/09/1997	10/09/1997	0		PUB	PVT	Ortho-Novum	NA	NA	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~4978160~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0103185	10/15/1997	GA	38.0	38		F	10/10/1997	redness on arm, fever, diarrhea the next day;freezing cold the next day, hives;MD prescribed ATB;				Y					U	10/07/1997	10/07/1997	0		UNK	PVT		NONE		~ ()~~~In patient		1						1	Chills; Diarrhoea; Pyrexia; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81862~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0103190	10/15/1997	CA	41.0	41		F	10/10/1997	problems breathing, swelling of the armpit;									U	10/07/1997	10/07/1997	0		UNK	PVT	Clondine;Hydorxycine;Trazodone;		asthma, migraines, insomnia, menopause;	~ ()~~~In patient		1						1	Dyspnoea; Lymphadenopathy	FLU3~CONNAUGHT LABORATORIES~7F81862~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103192	10/15/1997	CA	36.0	36		F	10/10/1997	back pain, arm swollen & feels hot;									Y	10/08/1997	10/08/1997	0		UNK	PVT				~ ()~~~In patient		1						1	Back pain; Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81862~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103197	10/15/1997	PA	71.0	71		F	10/09/1997	sore arm 2 days @ site also drew around to muscle;									Y	10/05/1997	10/05/1997	0		PVT	UNK	Glynase;Zoloft, Xanax, Zestril, Bumex, Glucopage, Mevacor;Plaquetol;	NONE	dichetes	~ ()~~~In patient		1						1	Injection site pain; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~A~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0103200	10/15/1997	MA	43.0	43		F	10/06/1997	approx 4hr p/vax got fever, swollen gland in throat, vomiting, upper resp congestion;h/a, fever seemed quite high;muscle contractions & aches;sx dissipated p/4hr;APAP;									Y	09/29/1997	09/29/1997	0	NA	OTH	UNK	Premphase;Sudafed	NONE	NONE	~ ()~~~In patient		1						1	Headache; Lymphadenopathy; Muscle twitching; Myalgia; Pharyngitis; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81793~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103205	10/15/1997	AK	73.0	72		F	09/30/1997	pt recv vax 29SEP97 7hr later pt had local redness & pain (severe) w/left arm;12hr later arm red, swollen, itchy;									Y	09/29/1997	09/29/1997	0		PVT	PUB	Premarin;Voltaren	NONE	NONE other than degenrative arthritis;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Oedema peripheral; Pruritus; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~3257FA~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0001D~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0103157	10/16/1997	VA	66.0	66		F	10/10/1997	non cardiogenic pulmonary edema, metabolic acidosis (severe) & intractable hypotension about 3hr p/vax;requiring mechanical ventilation, vasopressor;similar case of ARDS in MAY97 w/o etiology;No known vax given then;plumonary edema			Y	Y	Y		Y			10/07/1997	10/07/1997	0	pulmonary edema by CXR severe lactic acidosis, hypotension	PVT	PVT	Zocot, Neurontin, Premarin, HCTZ, Zoloft, Allegra;	NONE	HTN, sz disorder, Depression	NONE~ ()~~~In patient		1						1	Acidosis; Hypotension; Hypoxia; Pulmonary oedema	FLU3~CONNAUGHT LABORATORIES~7F81770~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0103207	10/16/1997	CT	7.0	7		M	10/13/1997	hives p/flu vax 10OCT97 faces & lips swollen;hives inside mouth-wheezing-SOB;									Y	10/10/1997	10/10/1997	0		PVT	UNK		NONE	hx asthma/bronchitis;	~ ()~~~In patient		1						1	Asthma; Condition aggravated; Dyspnoea; Face oedema; Stomatitis; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81723~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103209	10/16/1997	AL	26.0	26		F	10/09/1997	fever, localized edema @ site, malaise;				Y					Y	10/07/1997	10/08/1997	1	NONE	PUB	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site oedema; Malaise; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~4978190~1~IM A~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0103166	10/17/1997	OR	63.0	63		F	10/15/1997	14OCT collapsed, disorientated, combative, uncooperative, diaphoretic, very sensitive to touch, intubated, dec paralyzed for CT, IV, haldol, LP, FC;extubated confusion cont on 15OCT;dx likely allergic rxn to f/u shot r/o encephalitis mening			Y	Y	Y				U	10/07/1997	10/14/1997	7	LAB/CT negative;LP results=68 protein, 73 glucose 2WBC;1RBC;chem, sed rate, CBC, UA, ANA, ammonia;	MIL	PVT	HCTZ, Premarin, CACL, TOprol, Lotensin	NONE	NKA			1						1	Confusional state; Hostility; Hyperaesthesia; Hyperhidrosis; Laboratory test abnormal; Personality disorder; Shock; Amnesia; CSF test abnormal; Coma; Encephalopathy; Hyperaesthesia; Hypertension; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81757~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7F81757~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0103167	10/17/1997	MN	40.0	40		M	10/13/1997	6OCT vax given 1400;7OCT hot flushes started 630PM blacked out 9PM w/subsequent black outs;seen by MD;has 8 sec periods where heart stopped;adm to CCU w/6-7times, 8sec heart stopped;pacemaker considered-last episode 8OCT 130PM;				Y	Y	3				10/06/1997	10/07/1997	1	EPS, EKG, Holter Monitor, CXR, Lab draws x 4-enzymes, ETC;	OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Cardiac arrest; Syncope; Vasodilatation	FLU3~PFIZER\WYETH~4978168~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0103214	10/17/1997	CA	42.0	42		F	10/11/1997	pt states that approx 6-7hr p/vax pt was noted to devel a wheeze;lips swollen & numb & puffy eyes;cleared spontaneously;									Y	10/08/1997	10/08/1997	0	NONE	PUB	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Asthma; Face oedema; Paraesthesia oral	FLU3~CONNAUGHT LABORATORIES~7F81884~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103217	10/17/1997	NH	38.0	38		M	10/09/1997	sudden onset neck stiffness, abd pain, aching, low grade fever 103, chills;still felt ill late afternoon;seen by MD early PM 9OCT feels better this AM;				Y					Y	10/08/1997	10/08/1997	0	NONE	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Abdominal pain; Chills; Malaise; Myalgia; Nuchal rigidity; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81771~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0103220	10/17/1997	NV	43.0	43		F	10/14/1997	low back pain, thoracic myositis & pain;myalgia & arthralgia;										10/08/1997	10/13/1997	5	ESR;chem panal CBC;	PUB	OTH		NONE	NONE	NONE~ ()~~~In patient		1						1	Arthralgia; Back pain; Myalgia; Myositis; Pain	FLU3~CONNAUGHT LABORATORIES~7F61799~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103236	10/20/1997	NC	63.0	63		F	10/08/1997	blurred vision @ 1110: mouth dry, tongue swollen, face flushed;									Y	10/08/1997	10/08/1997	0		PUB	PUB	Centrum;Diabeta;Premarin;Oridis	NONE	mild diabetes;	~ ()~~~In patient	NC97099	1						1	Amblyopia; Dry mouth; Tongue oedema; Vasodilatation	FLU3~PFIZER\WYETH~4978145~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0103238	10/20/1997	FL	36.0	36		F	10/14/1997	pt seen for allerg rxn to flu shot;pt reports pruritus & very mild tightening of chest;had flu shot every yr w/o difficulties;localized erythema of face & neck w/hives;BP 110/68, P60 & t99;poss allerg rxn;									Y	10/13/1997	10/13/1997	0	NA	OTH	OTH	NA	NA	NONE	NA~ ()~~~In patient		1						1	Chest pain; Hypersensitivity; Hypotension; Pruritus; Pyrexia; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81861~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103253	10/20/1997	CA	58.0	58		M	10/07/1997	pt recv vax 3OCT97 6PM;swelling to twice arms original size from shoulder to elbow severe itching;told no one until 7PM on 4OCT97;given DPH for itching arm & iced arm;									Y	10/03/1997	10/05/1997	2	NONE	OTH	PUB	Orudis NS anti inflammatory, histafed;	NONE	hayfever, long term smoker, COPD	NA~ ()~~~In patient	CA970081	1						1	Oedema peripheral; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81841~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0845D~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0103256	10/20/1997	CA	50.0	50		F	10/03/1997	erythema & itching @ inj site;									Y	10/03/1997	10/03/1997	0	NONE	PUB	PUB		NONE	allergy to strawberries	~ ()~~~In patient	CA970079	1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81860~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103273	10/20/1997	CA	46.0	46		F	10/06/1997	blister @ inj site;fatigue noted in evening when @ home noted blister in evening;reddened area w/bandaid covering an open blister area;did not feel well;redness, swelling & induration;h/a;chills, swollen gland;										10/03/1997	10/03/1997	0		OTH	OTH				~ ()~~~In patient		1						1	Asthenia; Chills; Headache; Injection site hypersensitivity; Injection site oedema; Lymphadenopathy; Malaise; Skin ulcer	FLU3~CONNAUGHT LABORATORIES~7F81862~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103276	10/20/1997	OH	81.0	81		F	10/06/1997	Saturday AM around 5AM lt hand was swollen had a red hot burning sensation;couldn't get had closed together;it did let up a little pt soaked it;hand cont to hurt but did nl chores;ecchymosis @ inj site;									Y	10/03/1997	10/04/1997	1		PUB	PUB	Atenolol for high blood pressure	NONE	had polymyalgia & was on steroids for 4-5hr (pred);	~ ()~~~In patient	OH97070	1						1	Ecchymosis; Hypokinesia; Oedema peripheral; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81754~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103277	10/20/1997	OH	43.0	43		M	10/10/1997	approx 2hr p/vax had thickening of tongue;thirst approx 3hr p/vax;itching;completely covered w/red blotches & welt;seen by MD;itching started 4-5hr p/vax; next day rash about gone;				Y					Y	10/09/1997	10/09/1997	0	NA	OTH	PUB		NONE	NKA-hypertension	~ ()~~~In patient	OH97071	1						1	Pruritus; Rash maculo-papular; Thirst; Tongue oedema; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81917~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0103280	10/20/1997	OH	61.0	61		F	10/03/1997	awoke w/nausea & severe h/a in back of head w/gen aching;called personal MD 2OCT97 @ 730AM who told pt to report to VAERS;									Y	10/01/1997	10/02/1997	1	NONE	PUB	PUB	Ogen, Prilosec, Clidinium CDP, Darvocet, Abutrol;Azmacort	arthritis;in & out of hosp this past year;	arthritis, ?blood disorder, asthma attacks, rxn to erythromycin in 1975;	~ ()~~~In patient	OH97074	1						1	Headache; Myalgia; Nausea	FLU3~CONNAUGHT LABORATORIES~7F81788~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103282	10/20/1997	IN	39.0	39		F	10/18/1997	pt has swollen red blotch rt deltoid p/vax 15OCT97;										10/15/1997				PVT	UNK		NONE	NONE	NONE~ ()~~~In patient		1						1	Oedema peripheral; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~7F81718~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103283	10/20/1997	IN	37.0	37		F	10/16/1997	hives-woke up w/hives on chest the next morning;local swelling & pain @ site temp 98.3;17OCT97;had inc swelling & surface erythema;				Y						10/15/1997				OTH	OTH	Synthroid	NONE		~ ()~~~In patient		1						1	Injection site oedema; Injection site pain; Oedema; Pyrexia; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81864~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0103285	10/20/1997	NJ	50.0	50		F	10/14/1997	dry mouth & metallic taste in mouth starting 1/2hr post vax;reported back to med dept @ 4PM;exam no abnormal findings;									Y	10/08/1997	10/08/1997	0	NONE	OTH	PVT	Estrogen;Prilosec	NONE	No allergies	NONE~ ()~~~In patient		1						1	Dry mouth; Dysgeusia	FLU3~CONNAUGHT LABORATORIES~7J81850~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103287	10/20/1997	OH	65.0	65		M	10/14/1997	fine red rash, itching on trunk & arms;lungs clear: no resp difficulty, afeb;DPH given;									Y	10/10/1997	10/10/1997	0	NA	MIL	UNK		ALS, duodena glaucoma ulcer	ALS, duodena glaucoma ulcer	~ ()~~~In patient		1						1	Pruritus; Rash maculo-papular	FLU3~PFIZER\WYETH~4978197~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0103300	10/20/1997	NY	66.0	66		M	10/16/1997	w/in few days of vax pt devel vertigo, n/v;no other sx;+ mild end gage nystagmus rt gaze;pt reports similar rxn last time recv flu shot;				Y					U	10/07/1996			NONE	PVT	UNK		NONE	type 2DM;CVD, CVA, peptic dz, no allergies;	~ ()~~~In patient		1						1	Nystagmus; Vertigo; Visual disturbance; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81745~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0103301	10/20/1997	NY	67.0	67		M	10/16/1997	pt devel vertigo, n/v;no other sx;+ mild end gaze nystagmus rt gaze;				Y					U	10/07/1997	10/07/1997	0	NONE	PVT	UNK		NONE	type 2DM, CVD, COPD, CVA, peptic dz, no allergies;	pt recv flu vax & devel vertiog, n,v, nystagmus w/flu vax;~ ()~~~In patient		1						1	Nystagmus; Vertigo; Visual disturbance; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81745~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0103320	10/21/1997	SC	66.0	66		F	10/14/1997	swelling of the arm;t99.4, chest congested, coughing;									N	10/13/1997	10/13/1997	0	NONE	PUB	PUB				~ ()~~~In patient	SC97061	1						1	Cough; Oedema peripheral; Pharyngitis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0103321	10/21/1997	MS	70.0	70		M	10/21/1997	arm swelled immed-red-down below elbow;pt ran fever-pt rx ATB;				Y					Y	10/14/1997	10/14/1997	0	NONE	PUB	PUB	Cedax	NONE	NONE	~ ()~~~In patient	MS97038	1						1	Oedema peripheral; Pyrexia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0103324	10/21/1997	NJ	67.0			F	10/17/1997	arm itching, inj site black & blue raised area size of silver dollar-red-tingling in both arms & legs;felt warm still sensitive p/1wk;									N	10/10/1997				UNK	UNK				~ ()~~~In patient		1						1	Ecchymosis; Injection site mass; Paraesthesia; Pruritus; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~7F81888~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0103325	10/21/1997	NY	36.0	36		F	10/16/1997	pt exp fever, chills, SOB, conjunctivitis, productive cough, grad resolved over noc followed by a confluent fine rash on neck & trunk;				Y					Y	10/07/1997	10/07/1997	0	NONE	OTH	PVT	NONE	NONE	mild asthma, evnironment;allergies not identified;	~ ()~~~In patient		1						1	Chills; Conjunctivitis; Cough; Dyspnoea; Pyrexia; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~7F81884~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0103326	10/21/1997	CA	75.0	75		F	10/14/1997	3rd day post vax pt devel temp, neck sore, sneeze, cough, h/a, sinus stopped up, ache in neck;									N	10/10/1997	10/13/1997	3	NONE	OTH	OTH				~ ()~~~In patient		1						1	Cough; Headache; Myalgia; Neck pain; Pyrexia; Rhinitis; Sinusitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0103327	10/21/1997	MN	59.0	59		M	10/15/1997	nausea, vomit, not much to eat, drink clear liquids;									N	10/11/1997	10/14/1997	3	NONE	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Anorexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0103328	10/21/1997	CA	23.0	23		F	10/16/1997	arm hurt, devel 1 diameter bump, redness 2 in diameter;hot-cont to get worse;hurt to touch or move-got larger everyday @ inj site;									N	10/11/1997	10/11/1997	0	NONE	OTH	OTH	BC pills	NONE	NONE	pt sibling passed out w/tet, hep vax;~ ()~~~In Sibling		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Myalgia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~3~~~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0103329	10/21/1997	OH	40.0	40		M	10/16/1997	severe h/a, stiff neck, beet red throat, ear pain, poss strep;				Y					N	10/14/1997	10/14/1997	0	throat cult	OTH	OTH	NONE	NONE	hx of compazene & sulfa rxn;	~ ()~~~In patient		1						1	Ear pain; Headache; Infection; Nuchal rigidity; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~7F81759~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0103334	10/21/1997	MA	54.0	54		M	10/15/1997	2hr p/vax pt states felt weak, h/a, dizzy;				Y					Y	10/10/1997	10/10/1997	0	chem of profile;	PUB	PUB	synthroid;Toprol, Norvasc	NONE	diabetes angina hypothyroid;menieres in past	NONE~ ()~~~In patient	MA9748	1						1	Asthenia; Dizziness; Headache; Dizziness; Headache	FLU3~CONNAUGHT LABORATORIES~7F81793~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7F81793~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0103334	10/21/1997	MA	54.0	54		M		pt recv vax & devel lightheadedness & h/a (frontal);lightheaded when walking;dx flu vax rxn;				Y					Y	10/10/1997	10/10/1997	0	T96.2, P76, R24, BP 153/73, exam WNL;	UNK	UNK	Toprol, Levothyroid, Norvase		diabetes, angina, low thryoid, allergy-PCN	~ ()~~~In patient		1						2	Asthenia; Dizziness; Headache; Dizziness; Headache	FLU3~CONNAUGHT LABORATORIES~7F81793~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7F81793~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0103336	10/21/1997	NH	35.0	35		M	10/14/1997	severe swelling, erythema, lymphadenopathy;rt deltoid site of inj of pneumococcal vax & flu vax w/fever & pain;				Y						10/13/1997	10/14/1997	1		PVT	OTH	Insulin;Pancrease;Albuterol;Vit K;Aerobid;	NONE	cystic fibrosis diabetic sinusitis;	~ ()~~~In patient	NH97024	1						1	Injection site hypersensitivity; Injection site oedema; Lymphadenopathy; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81888~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~433182~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0103341	10/21/1997	MA	57.0	57		F	10/12/1997	pt recv vax & pt noticed a red blanched mark on site of inj;w/in a couple of hr pt noted this;also some local itching;did not report this until Thursday;no other sx;									Y	10/07/1997	10/07/1997	0	NONE	OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81802~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103342	10/21/1997	MA	59.0	59		F	10/12/1997	pt recv vax & c/o tenderness @ site & next day noticed red mark @ inj site;also c/o nausea & stomach upset x 3 days;not reported until 9OCT97;									Y	10/07/1997	10/08/1997	1	NONE	OTH	PVT	Pred	NONE		~ ()~~~In patient		1						1	Dyspepsia; Injection site hypersensitivity; Injection site pain; Nausea	FLU3~CONNAUGHT LABORATORIES~7F81802~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103343	10/21/1997	MA	39.0	39		F	10/12/1997	pt recv vax & that noc exp local redness @ inj site;next day c/o hot flashes;called MD;									Y	10/07/1997	10/07/1997	0		OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81802~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103344	10/21/1997	MA	59.0	59		F	10/12/1997	pt recv vax & c/o mild itching p/shot but next day noticed red mark over 2 in diameter;had no other sx;									Y	10/07/1997	10/08/1997	1		OTH	PVT	NONE	NONE		~ ()~~~In patient		1						1	Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81802~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103345	10/21/1997	MA	57.0	57		F		pt recv vax & 2hr p/vax pt noticed swelling & redness;did not notify clinic until 10OCT97;next day pt felt nausea, sore arm, redness;no other sx;noticed bruise @ site;									Y	10/07/1997	10/07/1997	0		UNK	UNK	Hormone	NONE	bronchial plexus injury	~ ()~~~In patient		1						1	Ecchymosis; Nausea; Oedema; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81802~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103346	10/21/1997	MA	56.0	56		F	10/12/1997	pt recv vax & p/15min pt c/o mild itch;but 2hr later noticed warmth & redness;bruise formation also noted;no tx was given;pt did not report this until next day;									Y	10/07/1997	10/07/1997	0		OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Ecchymosis; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81802~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103347	10/21/1997	MA	30.0	30		F	10/12/1997	pt recv vax & p/20min pt c/o itch;did not report until next day had a dime size red mark @ site;no other sx reported, no tx									Y	10/07/1997	10/07/1997	0		OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81802~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103348	10/21/1997	MA	51.0			F	10/13/1997	pt recv vax & next day pt reported sore arm, sl redness, hard bumps at site;also exp nausea & stomach pains;feels bumpy spot;nausea still noted;													NONE	OTH	PVT	NONE	NONE		~ ()~~~In patient		1						1	Abdominal pain; Injection site mass; Nausea; Pain; Skin nodule; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81802~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103349	10/21/1997	MA	33.0	33		F	10/13/1997	pt recv vax & next day noticed redness @ inj site;resulted in 1 circumference;									Y	10/07/1997	10/08/1997	1		OTH	UNK		NONE		~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~7F81802~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103355	10/21/1997	CT	47.0	47		F	10/17/1997	above inj site-swelling in muscle to size of small apple-initially very hard, hot, red;swelling subsided on 5OCT97;red area approx 3x2 went away on 7OCT97;									Y	10/03/1997	10/03/1997	0	NA	OTH	PVT	Seldane, entex LA	NA	allergies dust, mold, cafferfot, cats, dogs, dalatid	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103359	10/21/1997	KS	5.0	5		M	10/13/1997	lt arm red, swollen, itching on SUnday had flu shot on Friday (swelling from shoulder to elbow);ER on Sunday-DPH & Motrin advised;redness gone, swelling inc on Monday p/DPH;				Y					Y	10/10/1997	10/12/1997	2		PUB	PVT		NONE	Rabbits	~ ()~~~In patient		1						1	Oedema peripheral; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4978140~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0103360	10/21/1997	IL				F	10/16/1997	dizzy, SOB, nausea, called ER from house;ER prescribed DPH;									Y	10/15/1997	10/15/1997	0	NA	PUB	PVT	NA	NA	NA	NONE~ ()~~~In patient		1						1	Dizziness; Dyspnoea; Nausea	FLU3~CONNAUGHT LABORATORIES~7F81852~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103361	10/21/1997	OH	59.0	59		F	10/11/1997	6hr p/vax pt began having swelling of lips, face, neck & tongue, coughing;seen in office & given Medrol dose pace & DPH;Denies any allergy to eggs;				Y					Y	10/10/1997	10/10/1997	0	NONE	PVT	PVT	HCTZ;Cardura;Altace	NONE		NONE~ ()~~~In patient		1						1	Cough; Face oedema; Tongue oedema	FLU3~CONNAUGHT LABORATORIES~7F81754~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0103368	10/21/1997	TN	43.0	43		M	10/15/1997	chills beginning @ 5hr post vax then fever to 103 x 36hr;mild myalgias;mild abd discomfort;									Y	10/10/1997	10/10/1997	0	NONE	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Abdominal pain; Chills; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81840~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103372	10/21/1997	WA	55.0	55		F	10/13/1997	croupy cough, non-productive, aches, inc temp, bruising, swollen hot area arm size of grapefruit;SOB w/walking;also itching;									U	10/11/1997	10/11/1997	0	NA	PVT	PVT	Levothyrozine;Lisinopril, Premarin, ASA, Aconation	NONE	hypothyrodism;HTN	sterile cellulitis in lt arm p/inj~ ()~~~In patient		1						1	Cough; Dyspnoea; Ecchymosis; Laryngitis; Myalgia; Oedema peripheral; Pruritus; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0103373	10/21/1997	NC	71.0	71		F	10/14/1997	pt recv vax 13OCT97 & reports rash initially on rt leg & spread to both arms;posterior thorax & presently on face w/swollen lips;instructed to notify primary care MD;				Y					Y	10/13/1997	10/13/1997	0	NONE	PUB	PUB	Metro gel	NONE	Rosocea	NONE~ ()~~~In patient		1						1	Face oedema; Rash	FLU3~CONNAUGHT LABORATORIES~7F81917~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0103374	10/21/1997	WI	58.0	57		F	10/15/1997	pt arm has sl redness & is itchy from pneumovax;									U	10/13/1997	10/14/1997	1	NONE	PVT	PVT	NONE	no illness	NONE	~ ()~~~In patient		1						1	Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4978161~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0332D~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0103375	10/21/1997	TX	51.0	51		M	10/14/1997	pain in chest, like somebody sitting on it; shoulders h/a took advil but had no relief;									Y	09/30/1997	09/30/1997	0		PVT	PVT	Lipitor	NONE	cholesterol kept low w/ciritor	NONE~ ()~~~In patient		1						1	Chest pain; Headache	FLU3~CONNAUGHT LABORATORIES~7F81816~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103377	10/21/1997	CA	22.0	22		F		pt recv vax 4PM & started itching 425PM;denies c/o SOB;02 sat w/room air 99-100%;50mg of DPH given IM;				Y					Y	10/14/1997	10/14/1997	0		MIL	UNK	none			~ ()~~~In patient		1						1	Pruritus	FLU3~PFIZER\WYETH~7978176~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0103379	10/21/1997	TX	49.0	49		F	10/10/1997	throat closed up;numbing pain spread to shoulders, chest, stomach (favoring rt side of torso-shot given in upper rt arm);felt like somebody was sitting on chest;felt like having heart attack;									Y	09/30/1997	09/30/1997	0		PVT	UNK	synthroid	NONE	benign cyst on throid;allergy PCN	NONE~ ()~~~In patient		1						1	Asthenia; Cardiovascular disorder; Chest pain; Headache; Influenza; Laryngospasm; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~7F81816~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103310	10/22/1997	MI	69.0	69		F	10/15/1997	h/a, chills, sweats, tired, nauseous, bed ridden 2 1/2 days;			Y						Y	10/02/1997	10/02/1997	0	NONE	OTH	OTH	Calderol, Myocalson	NONE	? could not understand recording;	~ ()~~~In patient		1						1	Asthenia; Chills; Headache; Hyperhidrosis; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0103393	10/22/1997	CA	68.0	68		F	10/15/1997	faint erythema stemming from the medial rt elbow over the lateral biceps area;no streaking axilla tenderness w/o palpable adenopathy;eve of inj had low grade fever & pain @ site;				Y					Y	09/26/1997	09/26/1997	0	NONE	PVT	PVT	Premarin	NONE	sulfa, morphine, PCN	NONE~ ()~~~In patient		1						1	Injection site pain; Lymphadenopathy; Pain; Pyrexia; Rash	FLU3~PFIZER\WYETH~4978150~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~438136~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0103395	10/22/1997	CA	79.0	79		M	10/21/1997	acute confusion, dizziness p/flu vax persisted 3 days;									Y	10/10/1997	10/10/1997	0		PVT	PVT		NONE		~ ()~~~In patient		1						1	Confusional state; Dizziness	FLU3~PFIZER\WYETH~4978215~2~A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0103396	10/22/1997	LA	0.5	0	.5	M	10/21/1997	persistent intermittent high pitched crying x 7 days;									Y	10/14/1997	10/14/1997	0		PVT	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Agitation; Crying; Agitation; Crying	DTP~LEDERLE LABORATORIES~448017~3~~LL~DTP (TRI-IMMUNOL)~1|FLU3~CONNAUGHT LABORATORIES~7F81829~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~PFIZER\WYETH~495RC~3~~RL~HIB (HIBTITER)~1|OPV~PFIZER\WYETH~169K5~3~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~1|DTP~LEDERLE LABORATORIES~448017~3~~LL~DTP (TRI-IMMUNOL)~2|FLU3~CONNAUGHT LABORATORIES~7F81829~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~PFIZER\WYETH~495RC~3~~LL~HIB (HIBTITER)~2|OPV~PFIZER\WYETH~769K5~3~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~2	USA		Influenza
0103397	10/22/1997	IL	9.0	9		F	10/17/1997	8x6 swelling of lt deltoid area;red, warm to touch;recv vax on 14OCT97;tx ceftin x 5 days to prevent;cellulitis;DPH;swelling had dec less warm to touch;									Y	10/14/1997	10/15/1997	1	NA	PVT	PVT	NA	NONE	NA	~ ()~~~In patient		1						1	Cellulitis; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4978149~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0103400	10/22/1997	TN	56.0	56		F	10/15/1997	temp 102;uncontrollable tremors;body weakness;h/a, chills;lasted approx 12-14hr;				Y					Y	10/02/1997	10/02/1997	0		PVT	PVT		sinusitis		~ ()~~~In patient		1						1	Asthenia; Chills; Headache; Pyrexia; Tremor	FLU3~CONNAUGHT LABORATORIES~7F81840~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0103401	10/22/1997	TN	68.0	68		M	10/15/1997	2hr p/vax had shaking chill w/nausea & malaise, t102 oral, one episode vomiting, gen musculoskeletal aches & pain, t102 till MN then temp 101 until 4MAR97 next day;				Y					Y	10/10/1997	10/10/1997	0		PVT	PVT	Acquinin;	mild abd pain below navel	NONE	~ ()~~~In patient		1						1	Chills; Myalgia; Pyrexia; Tremor; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81840~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0103402	10/22/1997	AZ	47.0	47		M		pt recv vax & was instructed to remain in area for 15-30min;10:45 pt c/o swelling sensation in throat;pt did not immed appear to be in distress smiling;upon being seated became diaphoretic & trembling;epi;				Y					Y	10/14/1997	10/14/1997	0		OTH	PVT		NONE	hx of bypass surgery	NONE~ ()~~~In patient		1						1	Hyperhidrosis; Laryngospasm; Tremor	FLU3~MEDEVA PHARMA, LTD.~3317GB~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0103404	10/22/1997	WA	30.0	30		F	10/16/1997	r/o sterile abscess or cellulitis of lt deltoid;				Y						10/14/1997	10/14/1997	0		UNK	UNK		NONE	migraines	~ ()~~~In patient		1						1	Cellulitis; Injection site abscess	FLU3~PFIZER\WYETH~4978174~7+~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~6L81392~1~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0103166	10/23/1997	OR	63.0	63		F	10/22/1997	few days p/vax pt exp malaise;13OCT97 h/a;14OCT97 pt  found unconscious @ home & transported to ER;regained consciousness but combative, failed to recognize husband;dysesthesia to touch;dx r/o meningitis & encephalitis;intubated in ER;				Y	Y		Y		Y	10/07/1997	10/14/1997	7	BP reported as 169/85;CSF clear but protein was reported as 68;glucose 73;RBC-1, WBC 2;serum chem & toxicology screens reported as pending;;	PUB	PVT	Hydrochlorothiazide, TOprol, Lotensin, Calcium Chloride & Premarin;		HTN & menopause;	~ ()~~~In patient	CO7644	1						2	Confusional state; Hostility; Hyperaesthesia; Hyperhidrosis; Laboratory test abnormal; Personality disorder; Shock; Amnesia; CSF test abnormal; Coma; Encephalopathy; Hyperaesthesia; Hypertension; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81757~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7F81757~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0103884	10/23/1997	RI	75.0			F	10/20/1997	redness, heat, induration, tenderness upper arm, axilla & chest wall;									Y	10/02/1997	10/03/1997	1		PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Pain; Skin nodule; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81860~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103885	10/23/1997	RI				F	10/20/1997	localized swelling, induration, redness, heat, pain, tenderness immed pain w/ensuing heaviness of the arm & swelling to shoulder & chest wall;									Y	10/08/1997	10/08/1997	0		OTH	PVT	NONE	unk	unk	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Myasthenic syndrome; Oedema peripheral; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81860~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103886	10/23/1997	RI				F	10/20/1997	localized swelling, induration, redness, heat, pain, tenderness;									Y	10/02/1997	10/03/1997	1		OTH	UNK	NONE	unk	unk	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81860~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103887	10/23/1997	RI				M	10/20/1997	localized swelling, induration, redness, heat, pain, tenderness;									Y	10/02/1997	10/03/1997	1		OTH	PVT	NONE	unk	unk	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81860~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103888	10/23/1997	RI				F	10/20/1997	localized swelling, induration, redness, heat, pain, tenderness;									Y	10/08/1997	10/08/1997	0		OTH	PVT	NONE	unk	unk	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81860~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103889	10/23/1997	MN	24.0			F	10/22/1997	local rxn 10cm x 12cm from mid arm to elbow lt area;Ibuprofen;									U				NOEN	PVT	PVT	Pred	viral bronchitis;	pharyngitis/asthma;	NONE~ ()~~~In patient		1						1	Injection site reaction	FLU3~PFIZER\WYETH~4978296~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~440421~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0103898	10/23/1997	WI	83.0	83		M	10/17/1997	14OCT97 pt devel sx of n/v & freq BM's;elevated temp of 102.3;uncontrollable shivering;NPO 14OCT97 p/7PM;clear liquids for 15OCT97 & full liquids 16OCT97;compazine supp PRN for n/v;									Y	10/13/1997	10/14/1997	1		OTH	UNK		NONE		~ ()~~~In patient		1						1	Chills; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81867~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103592	10/24/1997	PA	22.0	22		M	10/22/1997	pt recv vax OCT97 & pt was reportedly febrile;pt was 1 of 2 people vaccinated from the same household both of whom were dx w/Duchenne type muscular dystrophy;both pt suffered from chronic fevers of unk origin;pt hosp & expired;	Y				Y				N	10/16/1997	10/17/1997	1		UNK	UNK		fever of unk origin;	Duchenne type muscular dystrophy;recent dental surgery;	~ ()~~~In patient	CO7668	1						1	Unevaluable event	FLU3~CONNAUGHT LABORATORIES~7F81820~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0103593	10/24/1997	PA	19.0	19		M	10/22/1997	pt recv vax OCT97 & was reportedly febrile;both pt were reported to have been diagnosed w/Duchenne type muscular dystrophy;both pt were reported to have a hx of fever of unk origin;p/vax pt suffered resp failure hosp required mechanical ven			Y		Y				N	10/16/1997	10/16/1997	0		UNK	UNK		fever of unk origin;recent dental surgery	Duchenne type muscular dystrophy;recent dental surgery;	~ ()~~~In patient	CO7669	1						1	Hypoxia; Respiratory disorder	FLU3~CONNAUGHT LABORATORIES~7F81820~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0103599	10/24/1997	KS	38.0	38		F	10/03/1997	urticaria ge w/in 2 to 4hr pt recd epi & DPH;transferred to ER;recd solumedrol & DPH;admitted 23 hours observation -IV meds and nebulizer tx				Y	Y	1			Y	10/02/1997	10/02/1997	0		PUB	PUB	Synthroid	NONE	PCN, Tagamet, Compazine, sulfa, Bee stings	~ ()~~~In patient	KS97040	1						1	Urticaria	FLU3~PFIZER\WYETH~4978216~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0103911	10/24/1997	CA	5.0	5		M	10/23/1997	swelling, redness, hot area @ site of inj;									Y	10/20/1997	10/22/1997	2		PVT	OTH	NONE			~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81820~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103922	10/24/1997	VA	44.0	44		F	10/22/1997	lt arm site of inj noted site inc redness pt c/o discomfort @ this area & itching;T97.5;										10/20/1997	10/21/1997	1		PUB	UNK	Harmones, Estrogen patch	1wk prior not feeling well;	Cipro	~ ()~~~In patient		1						1	Hypothermia; Injection site hypersensitivity; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~4978167~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0103925	10/24/1997	NC	66.0	66		F	10/16/1997	that evening devel redness & warmth;It was slowly progressed & is painful;where is a wide band of indurated, erythematous skin that goes from should down inside upper arm & around elbow & over the trapezius;hyperpigmented coloration;				Y					Y	10/14/1997	10/14/1997	0		PVT	PVT	Calar SR	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Rash; Skin discolouration; Skin nodule; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3357GB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~441217~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0103927	10/24/1997	SC	45.0	44		F	10/15/1997	area redness size half dollar maybe sl larger around site inj;rash noted in redness-no rash else where visible;c/o intense itching where inj given;also c/o nausea, lightheadedness;DPH given;BP 150/80;arms from shoulder down to elbow mottled									Y	10/14/1997	10/14/1997	0		PUB	PUB		NONE	allergy PCN, Macrodatin	~ ()~~~In patient	SC97054	1						1	Dizziness; Hypertension; Injection site hypersensitivity; Nausea; Pruritus; Skin discolouration	FLU3~MEDEVA PHARMA, LTD.~E3287GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0103928	10/24/1997	CA	44.0	44		M	10/17/1997	severe pain @ time of vax;pain persisted @ site for about 5 days lessening gradually to a dull ache;bruising was evident on 26SEP97; 1 1/2 inch by 1inch;bruising dec very gradually still evident on 17OCT97 22 days later;				Y					N	09/25/1997	09/25/1997	0	NONE	OTH	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Ecchymosis; Injection site pain; Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~7F81814~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0103396	10/27/1997	LA	0.5	0	.5	M	10/21/1997	persistent intermittent high pitched crying x 7 days;									Y	10/14/1997	10/14/1997	0		PVT	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient		1						2	Agitation; Crying; Agitation; Crying	DTP~LEDERLE LABORATORIES~448017~3~~LL~DTP (TRI-IMMUNOL)~1|FLU3~CONNAUGHT LABORATORIES~7F81829~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~PFIZER\WYETH~495RC~3~~RL~HIB (HIBTITER)~1|OPV~PFIZER\WYETH~169K5~3~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~1|DTP~LEDERLE LABORATORIES~448017~3~~LL~DTP (TRI-IMMUNOL)~2|FLU3~CONNAUGHT LABORATORIES~7F81829~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~PFIZER\WYETH~495RC~3~~LL~HIB (HIBTITER)~2|OPV~PFIZER\WYETH~769K5~3~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~2	USA		Influenza
0103867	10/27/1997	MA	54.0	54		M	10/22/1997	severe chest pain during breathing, dull pain between shoulders blades;tx w/motrin dx pericarditis;				Y	Y	2			Y	10/15/1997	10/17/1997	2	02 sat, CXR, blood, heperin, EKG, serial enzyme;	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Back pain; Chest pain; Back pain; Chest pain; Pericarditis	FLU3~CONNAUGHT LABORATORIES~7F81793~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7F81793~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0103869	10/27/1997	PA	77.0	77		F	10/22/1997	nausea, vomiting, temp to 103, hypotension starting 102hr p/vax;required hosp;					Y	2			Y	10/15/1997	10/15/1997	0	elevated WBC (17,400);blood cult negative minor electrolyte abnormality	PVT	PVT	Adalat;Hydrochlorothiazide	HTN	severe adverse reaction to Td booster MAY95;	pt exp rxn @ 75 w/Td booster~ ()~~~In patient		1						1	Hypotension; Laboratory test abnormal; Leukocytosis; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81895~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0103929	10/27/1997	TN	57.0	57		F	10/13/1997	pt recv vax & approx 1wk post vax pt devel numbness & paralysis in lower legs, which traveled up the lt side of body to lt arm w/in 2wk;seen in clinic but no tx;dx GBS;pt stated has nerve damage in lt hip & numbness in heels of feet;abn CBC				Y					N	10/01/1994	10/07/1994	6	CBC abn;	PUB	OTH	Premarin;Synthroid	NONE		~ ()~~~In patient	897288014L	1						1	Asthenia; Guillain-Barre syndrome; Hypokinesia; Laboratory test abnormal; Neuropathy; Pain; Paraesthesia; Paralysis	FLU3~PFIZER\WYETH~~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0103932	10/27/1997	MS	69.0	69		M	10/17/1997	woke up 3AM on 15OCT97 w/severe pain in arm & chills;took APAP & went back to bed;went to clinic 16OCT97 w/swollen & red arms;17OCT97 came to clinic to see MD & arm much better today;				Y					Y	10/14/1997	10/15/1997	1	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MS97035	1						1	Oedema peripheral; Pain; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20017HC~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~436824~2~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0103936	10/27/1997	TX	71.0	71		F	10/19/1997	rapid onset of erythema, swelling, bruising, aches, pain, no fever tx ice, DPH;19OCT97437Pm had 8cm area of erythema w/5cm area of bruising-no induration-warm to touch;				Y					N	10/17/1997	10/17/1997	0	NONE	PVT	PVT	Lopressor,Elavil, Premarin	NONE	allergic Keflex, principen;prev severe rxn to immunotherapy	pt devel erythema, swelling @ 61yr old w/rabies dose 1;~ ()~~~In patient		1						1	Ecchymosis; Myalgia; Oedema; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4978139~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0103940	10/27/1997	CA	48.0	48		M	10/17/1997	swelling, redness area of inj;hot to touch;inc to peak spread size of softball by 3rd day p/inj;minor itch;all sx gone in 7 days;									Y	10/03/1997	10/03/1997	0	NONE	UNK	UNK	NONE	NONE	pollens, environmentals	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0103942	10/27/1997	WI	68.0	68		F	10/17/1997	rash on arm & chest-OCT hydrocortisone cream recommended;									U	10/10/1997	10/13/1997	3	NONE	PVT	PVT	Thioridazine;Synthroid, Pepcid	NONE	NKDA;hypothyroid;Schizophrenia;Hyperlipidemia;	~ ()~~~In patient		1						1	Rash	FLU3~CONNAUGHT LABORATORIES~7F81829~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~444067~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0103944	10/27/1997	RI	63.0	63		F	10/24/1997	Hives on head;itching;tx w/atarax & medrol dose pack;				Y					Y	10/22/1997	10/23/1997	1		UNK	UNK		NONE	PCN/sulfa;	~ ()~~~In patient		1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81894~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0103945	10/27/1997	IL				F	10/22/1997	pt recv vax 21OCT97 & devel redness around inj site w/itching followed by hives & sensation of thick tongue & diff swallowing;				Y					Y	10/21/1997	10/21/1997	0		OTH	UNK		NONE		pt devel swelling @ inj site last yr w/flu vax dose 1;~ ()~~~In patient		1						1	Glossitis; Injection site hypersensitivity; Laryngospasm; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0103947	10/27/1997	CO	33.0	33		F	10/22/1997	pt reported that had diarrhea & vomited tiwce the morning p/recv flu shot;pt recv yellow fever vax before the flu shot;									Y	10/14/1997	10/15/1997	1		PUB	PUB				~ ()~~~In patient	CO97051	1						1	Diarrhoea; Vomiting	FLU3~PFIZER\WYETH~4978165~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0103948	10/27/1997	WA	70.0	70		F	10/22/1997	pt reported exp rxn to vax w/in 1/2hr of vax;rt arm swelled, devel a red, splotchy rash & was very itchy;pt has been taking DPH & used ice for swelling;pt thinks the itching is letting up today 20OCT97									Y	01/16/1997	01/16/1997	0		PUB	UNK	Blood pressure meds;Premarin, Inuslin, Levator		NONE	~ ()~~~In patient		1						1	Oedema peripheral; Pruritus; Rash maculo-papular	FLU3~PFIZER\WYETH~497820~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~435960~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0103949	10/27/1997	CA	54.0	54		F	10/23/1997	pt had onset of severe body ache & flushing x 1 1/2hr the evening of the vax;pt very weak the next day;also c/o heart palpitations;									Y	10/22/1997	10/22/1997	0	NONE	PVT	PUB	Premarin;Verapamil	NONE	NONE	NA~ ()~~~In patient		1						1	Asthenia; Myalgia; Palpitations; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81841~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103951	10/27/1997	OR	39.0	39		F	10/23/1997	5cm diameter surrounding area of inj very red, warm;									Y	10/16/1997	10/17/1997	1		PVT	PVT				~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PFIZER\WYETH~4978154~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0103963	10/27/1997	CA	49.0	49		M	10/20/1997	48hr p/vax severe myalgias, rigors,chills & h/a;									Y	10/17/1997	10/19/1997	2	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Chills; Headache; Myalgia; Tremor	FLU3~CONNAUGHT LABORATORIES~7F81862~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103966	10/27/1997	CA	3.0	3		M	10/20/1997	on day of vax devel fever w/in 12hr (up to 103R) fever cont & arm became very swollen & red (7-10cm area, indurated, tender);				Y					Y	10/15/1997	10/15/1997	0	NONE	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Oedema peripheral; Pain; Pyrexia; Skin nodule; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81862~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0103967	10/27/1997	CA	20.0	20		F	10/20/1997	pt recv vax 1105AM pt found on floor;c/o h/a & feeling funny taken to clinic for eval;				Y					Y	10/20/1997	10/20/1997	0	CBC, SIO	PVT	PVT	NONE	NONE	NKA	NONE~ ()~~~In patient		1						1	Headache; Malaise; Syncope	FLU3~PFIZER\WYETH~4978200~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0103972	10/27/1997	CA	31.0	31		F	10/21/1997	1 1/2hr p/vax had a h/a, sl nausea, very tired;									N	10/20/1997	10/20/1997	0	NONE	PUB	UNK	APAP;Birth control pill	NONE	NONE	unk~ ()~~~In patient		1						1	Asthenia; Headache; Nausea	FLU3~PFIZER\WYETH~4978189~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0103973	10/27/1997	NY	10.0	10		F	10/13/1997	raised red area on rt upper arm;hives, red over entire trunk, more on lt side, lt arm, entire neck ears, some on rt armppit w/in 1hr of vax;tx w/DPH;				Y					Y	10/13/1997	10/13/1997	0		PVT	PVT		NONE	PKU, CP, developmentally delayed	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4978144~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~SMITHKLINE BEECHAM~2250A2~2~SC~LA~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0103974	10/27/1997	CT	27.0	27		F	10/16/1997	pt c/o itching @ site;lt arm became warm to touch, erythema to upper arm, swelling to the fingers;this occurred approx 5min p/vax;applied ice & administered DPH;sx subsided w/in 30min of initial episode;									Y	10/16/1997	10/16/1997	0	NONE	OTH	PVT	NONE	NONE	morphine, codeine, demoral	~ ()~~~In patient		1						1	Injection site hypersensitivity; Oedema peripheral; Pruritus; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81742~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103977	10/27/1997	MI	44.0	44		M	10/20/1997	burning sensation in lips/perioral area w/subsequent vesiculation/burning 13OCT;14OCT scaly area of the angles of the mouth similiar to angular cellitis;tx w/claritin;				Y					Y	10/13/1997	10/13/1997	0	NONE	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Cheilitis; Dermatitis bullous; Dry skin; Pain	FLU3~PFIZER\WYETH~4978190~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0103874	10/28/1997	KS	48.0			U	10/15/1997	pt recv vax 8OCT97 & exp flu sx;11OCT (3 days post vax) pt was seen in ER & was found to have a pneumothorax & infiltrates in 5 lung lobes;pt was hosp & required mechanical ventilation;cult was positive for streptococcus pneumoniae;			Y	Y	Y				U	10/08/1997	10/13/1997	5	cult positive for streptococcus pneumoniae	OTH	OTH	unk	NONE		~ ()~~~In patient	897294002L	1						1	Hypoxia; Infection; Influenza; Lung disorder; Pneumonia; Pneumothorax	FLU3~PFIZER\WYETH~4978184~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0103875	10/28/1997	VA				M	10/17/1997	pt inadvertently recv double dose of flu vax on 13OCT or 14OCT97;16OCT97 pt devel fever 104 which rose to 107;hosp;this is 1 of 80 pt from this facility to recv double dose of flu vax;17OCT97 the other 79 had no adverse exp;					Y				U	10/13/1997	10/16/1997	3		OTH	OTH	unk	unk	Parkinson disease w/tracheostomy, frequent upper resp infect	~ ()~~~In patient	897294008L	1						1	Pneumonia; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0103878	10/28/1997	MI	57.0	57		M	10/09/1997	pt recv vax 11SEP97 & came in 22SEP97 w/GBS expired 7OCT97 d/t ARDS secondary to pneumonia secondary to GBS;polyneuropathy d/t GBS;	Y	10/07/1997			Y	15			N	09/11/1997	09/22/1997	11	neuro consult suggested;polyneuropathy D/T GBS	UNK	UNK	NONE		allergies PCN;LBBB;	~ ()~~~In patient		1						1	Guillain-Barre syndrome; Neuropathy; Pneumonia; Respiratory disorder	FLU3~PFIZER\WYETH~4978168~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0103879	10/28/1997	WA	35.0	35		F	10/23/1997	numerous sz, aphasia, contusion, unresponsiveness treated w/acyclovir erythema for presumptive encephalitis;pt was intubated & sz activity cont through hosp;pt currently hosp day 7 w/relatively little change;				Y	Y	7			N	10/12/1997	10/14/1997	2	EEG-lt frontal temporall pseudoperiodic ? triphasic complex-diffuse slowing MRI & CT were nl;viral serologies & CSF PCR have all been negative;	OTH	OTH		flu-like illness, somnolence, fever 1 day prior to vax	PMM-partial nephrectomy in childhood, migraine HA	~ ()~~~In patient		1						1	Amnesia; Aphasia; Confusional state; Convulsion; Electroencephalogram abnormal; Encephalitis; Hypoxia	FLUX~UNKNOWN MANUFACTURER~~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0103880	10/28/1997	MD	59.0	59		F	10/21/1997	some itching, & a couple of small hives progressing later to cover entire body w/itching hands & bottom of feet itching;pred x 6 days;IV steroids-DPH;			Y	Y					N	10/17/1997	10/18/1997	1		OTH	PUB	Prempro;Ziban;Zocore	NONE	PCN, Zomax, bee, wasp, spider stings;	~ ()~~~In patient		1						1	Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~7+~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0103982	10/28/1997	MI	59.0	59		U	10/22/1997	sx of paraesthesias of lower extremities began 1wk post vax;sx porgressed to include up to umbilical area & hands;had  weakness of legs;tx w/immunoglobulins;					Y	5			Y	09/17/1997	09/24/1997	7	CSF protein 120, NMC blood count;	PVT	PVT				~ ()~~~In patient		1						1	Myasthenic syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~7F81755~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0103991	10/28/1997	MD	56.0	55		F	10/21/1997	arm swelled down to elbow-baseball size w/redness-lethargic-nausea, diarrhea, fever, chills;				Y					N	10/17/1997	10/17/1997	0	NONE	PVT	PVT	Toprol XL;	NONE	NONE	pt exp local site rxn w/flu & pneumoccal;~ ()~~~In patient		1						1	Chills; Nausea; Oedema peripheral; Pyrexia; Skin nodule; Somnolence; Vasodilatation; Chills; Diarrhoea; Oedema peripheral; Pruritus; Pyrexia; Somnolence; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~MEDEVA PHARMA, LTD.~E3367HC~5~SC A~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0103992	10/28/1997	SC	40.0	40		F	10/22/1997	local rxn-w/in 20min area was 6cm w/itching & some swelling;				Y					Y	10/02/1997	10/20/1997	18	NONE	UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLUX~UNKNOWN MANUFACTURER~4978182~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0103993	10/28/1997	PA	72.0	72		M	10/22/1997	severe chills, T101, treated w/motrin, felt weak & limp;better next day;									Y	10/17/1997	10/17/1997	0	NONE	OTH	PVT	unk	NONE	unk	~ ()~~~In patient		1						1	Asthenia; Chills; Hypotonia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81883~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103994	10/28/1997	CA	71.0	71		F	10/22/1997	cold, flu, bad cough following flu vax;										10/13/1997	10/19/1997	6		UNK	UNK				~ ()~~~In patient		1						1	Chills; Cough; Influenza	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0103995	10/28/1997	MA	60.0	60		F	10/24/1997	chills, perspiration on neck, S.T. early noc since administration of the flu shot;									Y	10/08/1997	10/08/1997	0	NONE	PUB	PUB	Zestril;Vitamins;Dilantin;st John wort;	NONE	legally blind, h/o sz;	~ ()~~~In patient	MA9720	1						1	Chills; Hyperhidrosis; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~7F81793~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0103998	10/28/1997	TX	72.0			F	10/21/1997	severe erythema multiforme required IV solumedrol to control the urticaria;pt has recovered;				Y					Y				all lab & x-ray to ER WNL;	PVT	UNK		NONE	NONE	NONE~ ()~~~In patient		1						1	Erythema multiforme; Urticaria	FLU3~CONNAUGHT LABORATORIES~75781752~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0104003	10/28/1997	WA	52.0	52		F	10/22/1997	11:55 c/o itching @ inj site-area sl red;12:00 c/o hand swelling-epi;pt states is fine-911 called given above site;12:05 DPH given c/o numbness, tingling face;9DEC c/o dizziness				Y					U	10/22/1997	10/22/1997	0		OTH	UNK		denied	unk	~ ()~~~In patient		1						1	Dizziness; Injection site hypersensitivity; Oedema peripheral; Paraesthesia; Pruritus	FLU3~PFIZER\WYETH~4978143~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104004	10/28/1997	TX	41.0	40		F	10/20/1997	fever, chills, ulcers to mouth, body aches;pt put on ATB-amoxil;				Y						10/17/1997	10/18/1997	1	NONE	PUB	PVT	Claritin;Zestril;Mevachs;PPD by connaught lot# 246411 given 17OCT97;	high BP, diabetic	sinus problem;high BP, diabetic;	~ ()~~~In patient		1						1	Chills; Mouth ulceration; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4978139~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104009	10/28/1997	OH	47.0	47		F	10/22/1997	redness, swelling from shoulder to elbow;tx w/ice, DPH, APAP;									Y	10/13/1997	10/14/1997	1	NOEN	PVT	UNK	Albuterol, Loparamide, Prilosex, HCTZ, adatat, propulad, premarin	NONE	allergy cipro;HTN, colitis;hiatal hernia;DJD	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~443662~1~IM~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0104011	10/28/1997	OH	56.0	56		F	10/22/1997	soreness, redness, blotching to lt deltoid treated w/APAP or advil;									Y	10/20/1997	10/21/1997	1	NONE	PVT	UNK	calcium, plaquenil;valium, vanceril, ventolin;naifen	NONE	NKA;asthma, depression,rheumataciarthritis, HTN, osteoarthritis	~ ()~~~In patient		1						1	Myalgia; Rash; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~443182~2~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0104013	10/28/1997	WA	42.0			F	10/22/1997	rash-swelling, eyes, lips;itching;sl resp change to group health;DPH;				Y					Y				NONE	PVT	PVT		NONE	allergies-some antibioties-pen sulfa mycin;asthma;	~ ()~~~In patient		1						1	Face oedema; Pruritus; Rash; Respiratory disorder	FLU3~PFIZER\WYETH~4878189~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104015	10/28/1997	MI	38.0	37		F	10/22/1997	320PM pt recvd vax & waited 15min @ 415PM felt nauseated & vomited;drank coffee & took APAP;hives appeared on neck & arms, for about 2hr;felt fine later;									Y	10/21/1997	10/21/1997	0	NONE	OTH	PVT	NONE	NONE	sinus problems occasionals	~ ()~~~In patient		1						1	Urticaria; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81855~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104022	10/28/1997	IN	4.0	4		F	10/22/1997	swelling, redness, itching @ inj site;rash on opposite arm, itching of ears & arms;									Y	10/18/1997	10/22/1997	4		PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Rash	FLU3~PFIZER\WYETH~4978149~4~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104024	10/28/1997	MI	61.0	61		F	10/20/1997	site of vax red, swollen (size of grapefruit) war to touch;tx ice, DPH ointment to site, DPH tablets;									Y	10/17/1997	10/17/1997	0	NONE	OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81754~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~7C91556~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0104026	10/28/1997	AZ	45.0			F	10/17/1997	localized lt deltoid edema, x24-48hr lt axillary tender adenopathy, low grade T99.5 oral;									U				NONE	PVT	UNK		localized reaction	unk	~ ()~~~In patient		1						1	Injection site oedema; Lymphadenopathy; Pyrexia	FLU3~PFIZER\WYETH~4978159~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104028	10/28/1997	TX		0	.0	F	10/23/1997	bruising, some edema, warm to touch;no nausea or vomiting, or pain;c/o itching in inj site only;reports area only uncomfortable;									Y	10/20/1997	10/21/1997	1	NONE	UNK	UNK	22OCT97 Naproysn;	NONE	very sensitive to all meds;	~ ()~~~In patient		1						1	Ecchymosis; Injection site hypersensitivity; Injection site pain; Oedema; Pruritus; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3337GB~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104030	10/28/1997	CA	69.0	69		F	10/23/1997	pt reports awakening morning p/shot w/pain in entire lumbar spin & rt sacroiliac & buttock;pt tender in described areas on 20OCT97;									U	10/10/1997	10/10/1997	0	NONE	PVT	PUB	Cotensin	NONE	H. simplex lt thigh 3JAN97, HTN;rt hip prosthesis	~ ()~~~In patient		1						1	Back pain; Pain	FLU3~CONNAUGHT LABORATORIES~7F81841~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104033	10/28/1997	IL				M	10/09/1997	w/in3hr of receiving flu vax pt broke out in hives on body;										09/26/1997	09/26/1997	0		UNK	UNK	claritin;		pt has hx of hives from unk causes approx 18mog ago;	~ ()~~~In patient		1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81744~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104034	10/28/1997	IL	31.0	31		F	10/09/1997	approx 2hr p/vax pt devel hives around inj site which then spread to the entire arm & then to other areas of body;pt tx w/DPH (w/limited improvements), then w/methylprednisolone dosepak;intermittent hives still occurring;									N	09/30/1997	09/30/1997	0		UNK	UNK	Clozaril		known allergy to PCN	~ ()~~~In patient		1						1	Injection site hypersensitivity; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81744~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104269	10/28/1997	TN	41.0	41		F	10/23/1997	rxn to flu shot given on 15OCT97;16OCT97 fever, bumps @ inj site & itching;blisters back of throat;MD dx as a rxn to the vax;										10/15/1997	10/16/1997	1	NA	UNK	UNK			NA	~ ()~~~In patient		1						1	Injection site hypersensitivity; Mucous membrane disorder; Pharyngitis; Pruritus; Pyrexia	FLU3~PFIZER\WYETH~4978165~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0103909	10/29/1997	TX	40.0	39		F	10/20/1997	itching @ site then gen itching & SOB-Zyrtec, maxaire, epi, pred for 5 days;			Y						Y	10/17/1997	10/17/1997	0		PVT	OTH	NONE	NONE	allergic Betadine, Formaldehyde	~ ()~~~In patient		1						1	Dyspnoea; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81752~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0104036	10/29/1997	FL	44.0	44		F	10/23/1997	c/o of arthritis sx in a prev injured leg w/in 24hr of vax;pain persisted till 23OCT97;saw PMD on 22OCT97 gave med anti-inflammatory;				Y					Y	10/03/1997	10/04/1997	1	NONE	PUB	PUB		NONE	injury to leg prev dx of arthritis	pt exp pain w/flu vax dose 1;~ ()~~~In patient		1						1	Arthritis; Condition aggravated	FLU3~MEDEVA PHARMA, LTD.~E3337GB~2~IM A~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0104037	10/29/1997	MA	49.0	49		F	10/22/1997	localized redness @ site of inj rt upper arm approx 2-3 around;no other signs or sx;									Y	10/20/1997	10/21/1997	1	NONE	PUB	PUB	Glucosanine;chondroitin	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~4978167~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104038	10/29/1997	TX	56.0	56		M	10/17/1997	itching to back-neck lt hive noted to neck area-head itching took ASA around 430AM 16OCT97;										10/17/1997	10/17/1997	0	NONE	PUB	PVT	ASA	sinus		~ ()~~~In patient		1						1	Pruritus; Urticaria	FLU3~PFIZER\WYETH~4978139~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104039	10/29/1997	VT	42.0	41		F	10/21/1997	8 1/2hr p/vax pt devel sl nausea, followed by uncontrollable shaking & teeth chattering;p/a period of rest pt devel a fever;T max 102 orally;had one other episode of violent shaking w/in the next 12hr;temp remained elevated for 36hr;									Y	10/17/1997	10/17/1997	0	NONE	OTH	PUB	oral contraceptive;Loestrin	NONE	endometriosis	NONE~ ()~~~In patient		1						1	Chills; Nausea; Pyrexia; Tremor	FLU3~CONNAUGHT LABORATORIES~7F81754~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104044	10/29/1997	SC	50.0	50		F	10/21/1997	swelling, pain, warmth, tenderness rt arm;				Y						10/20/1997	10/20/1997	0		PVT	PVT	DIlantin, Desyrel, Klonopin;Levsin PRN	NONe	pen, Motrin	~ ()~~~In patient		1						1	Oedema peripheral; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4978142~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~442521~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0104045	10/29/1997	CA	47.0	47		M	10/22/1997	was extremely tired went to bed, wake up @ 10:30 itching all over especially under arms, @ belt line, where shoes ties;had welts all over;went to ER was advised to use DPH;				Y					Y	10/20/1997	10/21/1997	1		PVT	PVT	Prinivil;Lipiton;Zoloft;	NONE	PCN-rash;	~ ()~~~In patient		1						1	Asthenia; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81758~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0104047	10/29/1997	AL	47.0	47		F	10/22/1997	h/a, diffuse arthralgias, 11x 7 cm, warm, erythematous, raised indurated plaque @ site of inj LUE;				Y						10/20/1997	10/21/1997	1		OTH	OTH		NONE	mixed connective tissue disease;asthma;	~ ()~~~In patient		1						1	Arthralgia; Headache; Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81858~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0103984	10/30/1997	NJ	34.0	34		F	10/28/1997	red flu 6PM-neck aches-7:30 102 fever, chills-muscle spasms in back-asthma attacks-APAP-now 100.6 fever-feel like full fledged flu;			Y						N	10/28/1997	10/28/1997	0	NA	OTH	OTH	NONE	NONE	asthma-NKA	NONE~ ()~~~In patient		1						1	Asthma; Chills; Condition aggravated; Hypertonia; Influenza; Myalgia; Neck pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0103985	10/30/1997	MD	43.0	43		F	10/27/1997	pt had chest pains, very cold,legs hurting-pain in legs;pt rushed to hosp;			Y	Y					U	10/27/1997	10/27/1997	0		PVT	PVT	unk	NONE	NONE	NA~ ()~~~In patient		1						1	Chest pain; Chills; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0103986	10/30/1997	IL	57.0	57		M	10/15/1997	1 days p/vax pt devel cellulitis # inj site;cellulitis extended to the elbow;pt was hosp on 29AUG & tx w/IV ATB;cellulitis resolved on 30AUG;this is 1 of 2 pt from this site to have an adverse exp p/vax;					Y	1			Y	08/28/1997	08/29/1997	1		PVT	OTH	Zestril;Zocor	NONE		~ ()~~~In patient	897290015LA	1						1	Cellulitis; Injection site reaction; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~440741~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0104049	10/30/1997	NC	32.0	32		F	10/25/1997	pt recv vax got sick had to leave work early;sweating, burning up, h/a, body aches, felt faint, dizzy, got up from desk-had to grab desk felt like going to pass out;sick to stomach;pain sharp on rt side lower abd;pain moving up										10/24/1997	10/25/1997	1	NONE	OTH	OTH	Synthroid;Guaifenefin;Hismanil;Hydroxythine;Tegretol;		thyroid disease, chronic h/a, mental disability, butal/APAP/caff;herpes;	~ ()~~~In patient		1						1	Abdominal pain; Dizziness; Dyspepsia; Headache; Hypokinesia; Myalgia; Pyrexia; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104050	10/30/1997	CA	74.0	74		F	10/23/1997	eve of vax pt became very sick extreme fever, body cold, body ache;									N	10/21/1997	10/21/1997	0	NONE	OTH	PUB	BP med	NONE	high BP	~ ()~~~In patient		1						1	Chills; Malaise; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104051	10/30/1997	TX	52.0	52		F	10/27/1997	pt recv vax & 3hr later diff breathing then sat & sun hives on chest, upper arms, back & neck;called clinic took DPH-no more hives sl fever also;									Y	10/23/1997	10/23/1997	0	NONE	PVT	PVT	Premarin & estrogen	NONE	NONE	NONE~ ()~~~In patient		1						1	Dyspnoea; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104052	10/30/1997	CA	61.0	61		M	10/28/1997	pt recv vax by late PM on 26OCT devel flu sx now having bad case of flu-rhinitis, fever, myalgia, usual sx;									N	10/24/1997	10/26/1997	2	NONE	OTH	OTH	NONE	NONE	myasthenia gravis-ocular sym only in remission	~ ()~~~In patient		1						1	Influenza; Myalgia; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104053	10/30/1997	ME	65.0	65		F	10/21/1997	fever 101, swelling lt side face, sore throat, lumps in throat;									N	10/17/1997	10/18/1997	1	CBC, ESR, HSP 2, UA, antibody test;	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	ME97022	1						1	Face oedema; Pharyngitis; Pyrexia	FLU3~PFIZER\WYETH~4978150~4~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104054	10/30/1997	NY	27.0	27		F	10/09/1997	pain, localized swelling @ site of vax;									Y	10/07/1997	10/07/1997	0	none	PUB	PUB	none	none	none	~ ()~~~In patient	NYS97051	1						1	Injection site oedema; Pain	FLU3~PFIZER\WYETH~4978169~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0104055	10/30/1997	IL	62.0	62		F	10/29/1997	pt reports waking the morning p/vax w/itchy hives on lt arm & scattered over body;applied cortisone cream to worse area (lt arm);states itching & hives are resolving slowly;									Y	10/16/1997	10/17/1997	1	NONE	PUB	PUB	NONE	NONE	amoxicillin & one other ATB, name unk;	unk~ ()~~~In patient	IL97098	1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81855~3~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104056	10/30/1997	ME	48.0	48		F	10/06/1997	h/a, nausea, chills, fever;									Y	10/01/1997	10/02/1997	1	NONE	PUB	PUB	unk	NONE	unk	~ ()~~~In patient	ME97020	1						1	Chills; Headache; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81817~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104063	10/30/1997	MS	49.0	49		F	10/20/1997	aching in rt hip & down rt leg x 3 days w/ s/s worsening by 3rd day;NP @ clinic ordered flexiril which has helped being able to sleep @ noc, APAP during daytime hrs;									Y	10/10/1997	10/10/1997	0		PUB	PUB	Claritan D	NONE	sinusitis	NA~ ()~~~In patient	MS97039	1						1	Insomnia; Myalgia	FLU3~MEDEVA PHARMA, LTD.~E20037KA~7+~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104071	10/30/1997	FL	65.0	65		F	10/20/1997	rt arm edematous (3x5mm size) x 24hr p/vax;pt called ER; pt called clinic 20OCT97 & reported redness in rt arm;pt arm was red from shoulder to elbow;rt arm cellulitis;swelling down arm from shoulder;allerg rxn;tired;yellow iodine stain;									Y	10/18/1997	10/18/1997	0		OTH	OTH	ASA;Claritin	NONE	HTN	NONE~ ()~~~In patient		1						1	Asthenia; Cellulitis; Hypersensitivity; Injection site hypersensitivity; Oedema peripheral; Skin discolouration; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81916~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~1627B~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0104072	10/30/1997	OH	32.0	31		F	10/11/1997	pt c/o pain @ inj site then shooting pain down arm, hand et neck;pt said neck had a dull ache;advised to take APAP for pain et to see MD if persists;has had flu vax q yr w/no problems;									U	10/11/1997	10/11/1997	0		OTH	PUB	NONE	NONE	pt prev had sprain to rt shoulder;	~ ()~~~In patient	OH97076	1						1	Injection site pain; Neck pain; Pain	FLU3~CONNAUGHT LABORATORIES~7F81754~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104073	10/30/1997	NC	79.0	79		F	10/28/1997	swelling & redness, swelling started primarily in the deltoid region & has spread distally down past the elbow @ this time;arm has been erythematous w/mild itching;				Y					Y	10/22/1997	10/23/1997	1		PVT	PVT				~ ()~~~In patient		1						1	Oedema peripheral; Pruritus; Rash; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3357GB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~441217~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0104077	10/30/1997	OH	78.0	78		M	10/08/1997	pt/vax pt noticed rash in lt axillary area about 2 or 3PM;rash was reddened & itchy that noc in bed;pt felt nauseated & feverish;next Am noted that rash was on entire lt arm & on lt side of torso down to waist;rash still present on 8OCT97;				Y					N	10/06/1997	10/06/1997	0		PUB	UNK	Tegretol	NONE	sz disorder	NONE~ ()~~~In patient	OH97075	1						1	Nausea; Pruritus; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~7F81788~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0104078	10/30/1997	HI	27.0			F	10/23/1997	approx 3 diameter redness, swollen, lumpy, painful @ inj site 2-3 days post vax;									Y	09/22/1997	09/24/1997	2		PUB	PVT		NONE		NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81819~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104079	10/30/1997	HI				F	10/23/1997	3 diameter @ site of inj red, swollen, hard, painful;aching feeling, chills;									Y	09/22/1997	09/22/1997	0		PUB	PUB		NONE		NONE~ ()~~~In patient	HI9706	1						1	Chills; Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Myalgia	FLU3~CONNAUGHT LABORATORIES~7F81819~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104080	10/30/1997	HI	57.0			F	10/29/1997	3 diameter redness, pain, swelling, lumpiness @ inj site;									Y	09/26/1997	10/27/1997	31		PUB	PVT		NIL		NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81819~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104081	10/30/1997	HI	38.0			F	10/29/1997	3 redness, swelling, lumpy, painful diameter;+hives, whole arm swollen;									Y	09/25/1997	10/25/1997	30		PUB	PVT		NONE	employee does have other allergies	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Oedema peripheral; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81819~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104082	10/30/1997	HI	46.0			F	10/29/1997	3 diameter, redness, swelling, lumpy, painful @ inj site;									Y	09/25/1997	09/26/1997	1		PUB	PVT		NIL		NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81819~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104083	10/30/1997	HI	45.0			F	10/23/1997	1 diameter redness, 3 diameter lumpiness @ inj site;									Y	10/13/1997	10/14/1997	1		PUB	PVT		NIL		NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~7F81819~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104084	10/30/1997	OH	46.0	46		M	10/30/1997	on second day p/vax severe chills, sweating & uncontrollable shivering for several hr;regular blankets, electric blanket, & hot showers required to stop chills;muscle pain @ point of vax;other muscle pain also;									Y	10/27/1997	10/28/1997	1	NONE	OTH	PVT	NONE, vitamin supplements	NONE-athlete	sulfa drugs	~ ()~~~In patient		1						1	Chills; Hyperhidrosis; Injection site pain; Myalgia; Tremor	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104094	10/30/1997	CT	80.0	80		M	10/30/1997	pt c/o not feeling well while in car w/wife;EMS was called when arrived pt was in cardiac arrest;attempts to revive failed was transported to hosp ER states COD listed on ER record as cardiac arrest;	Y	10/28/1997		Y					N	10/28/1997	10/28/1997	0	BP was taken @ clu clinic as a routine service offered to pt 130/66;	PUB	PUB	unk	unk	diabetes, others not known	~ ()~~~In patient	CT9711	1						1	Cardiac arrest; Malaise	FLU3~MEDEVA PHARMA, LTD.~E3337GB~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0104098	10/30/1997	MO	81.0	81		M	10/21/1997	sudden onset of chills & SOB @ approx 130PM;vomited x 1;MD notified;taken to ER, T101.1;IV fluids & ATB, 02 given @ noc as blood 02 level was low;11OCT97 pt dismissed w/ATB;Zithromax which was completed;21OCT97 pt recovered;				Y	Y	2			Y	10/09/1997	10/09/1997	0	blood oxygen wa low	PUB	PUB	Lasix, K-dur,Folic acid, iron tablets	NONE	heart attach 80, leg amputee (tumor) 1949, Crohn's disease;	pt recv flu shot 95 & 96 w/o adverse event;~ ()~~~In patient	MO97044	1						1	Chills; Dyspnoea; Hypoxia; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81816~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0104105	10/31/1997	MA	23.0	23		F	10/26/1997	the next day p/vax pt w/red raised rash, chills, did not check temp;denies resp distress;pt returned call to RN 22OCT97-cont w/rash;RN encouraged to see MD;denies any known allergies to eggs/chicken/thimerisol or latex;									Y	10/11/1997	10/12/1997	1	NONE	OTH	PVT		NONE	NONE	NONE~ ()~~~In patient		1						1	Chills; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~7F81895~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104110	10/31/1997	MA	35.0	35		F	10/07/1997	pt recv vax & 45min p/vax c/o sore arm, warmth, soreness @ area upon eval arm inj site warm, swollen to 3 size, firm @ site as well;called MD who ordered to apply ice to area;pt to take DPH;									Y	10/07/1997	10/07/1997	0		PUB	UNK		NONE-has been getting allergy shots;	pollen, dogs, cats, dust mite, mold, ragweed;	~ ()~~~In patient	MA9707	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Myalgia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81793~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104111	10/31/1997	MA	50.0	49		F	10/08/1997	woke up w/hives on trunk & arms & legs-took DPH x 3 doses;hives returned;saw on MD on 3OCT;tx w/pred then dec each day by one;also took DPH cap;7OCT97 no hives;				Y					Y	10/01/1997	10/02/1997	1		OTH	UNK			PCN	~ ()~~~In patient	MA9708	1						1	Urticaria	FLU3~MEDEVA PHARMA, LTD.~E3287GH~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0104112	10/31/1997	MA	72.0	72		F	10/21/1997	29OCT local inj site swelling noted 4 diameter;area itchy w/o pain or redness;swelling resolved by 21OCT;									Y	10/18/1997	10/19/1997	1		PUB	OTH	Pred	chronic lupus		~ ()~~~In patient	MA9709	1						1	Injection site oedema; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81793~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104117	10/31/1997	OR	70.0	70		F	10/17/1997	4cm diameter erythema around inj site;									Y	10/09/1997	10/10/1997	1	NONE	PVT	UNK		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~4978152~1~SC A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104120	10/31/1997	MA	77.0	77		F	10/23/1997	redness & swelling from rt arm @ inj site to elbow given 16OCT97 reported to office 17OCT97;rx 17OCT97 w/APAP & DPH;22OCT97 pt on atarax & pred taper;				Y					Y	10/16/1997	10/17/1997	1		PVT	OTH	Tenormin;Advi; w/meals	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~7F81793~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0993E~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0104121	10/31/1997	SC	37.0			U		very swollen 4.5cm by RN;very red, hot to touch, swollen knot 5 days;									Y	10/21/1997	10/22/1997	1	NONE	PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Oedema; Skin nodule; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104123	10/31/1997	NJ	68.0			M	10/27/1997	rt arm 1 1/2x original size by 530PM, hot to touch & sensitive, flu-like sx lasted 5 days;19OCT97 UTI, nausea & vomiting;currently on ATB for the infect;				Y					Y	10/16/1997	10/16/1997	0	urine test;	PUB	PUB	Wellbutin;Buockedrin;	NONE	migraine/high BP;	~ ()~~~In patient	NJ9739	1						1	Influenza; Injection site hypersensitivity; Injection site pain; Urinary tract infection; Vasodilatation; Vomiting	FLU3~PFIZER\WYETH~4978208~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0331D~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0104125	10/31/1997	UT	67.0	67		M	10/09/1997	lt upper arm around site of pneumococcal vax red swollen the size of a grapefruit w/red streak behind, hot to touch & painful;required IV ATB;				Y					Y	10/07/1997	10/08/1997	1		PUB	PUB	Accupril	NONE	HTN	NONE~ ()~~~In patient	UT971832	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pain; Skin striae; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1627B~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0104126	10/31/1997	UT	75.0	75		F	10/18/1997	1wk p/vax pt devel 2 blotches on lt upper arm;the top blotch was 4 x 2 beginning @ the top of shoulder then space w/the bottom blotch 3 x 3 a  little above the elbow;described as bright red & warm to touch;				Y						10/10/1997	10/17/1997	7		PUB	PUB	Synthroid;Premarin;Amatryptoline	NONE	NONE	NONE~ ()~~~In patient	UT971831	1						1	Rash; Vasodilatation	FLU3~PFIZER\WYETH~40980351~7+~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~7E91657~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0104127	10/31/1997	UT	35.0	35		F	10/09/1997	lt upper arm devel a lump the size of a tennis ball, sore, swollen & sl pink;also neck is some, stiff & achy like flu;sx began 24hr p/vax;lump began to go down by 3 days & sl pink;									Y	10/06/1997	10/07/1997	1	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	UT971830	1						1	Influenza; Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Neck pain; Nuchal rigidity	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0104130	10/31/1997	MD	45.0	45		F	10/10/1997	stiff neck, chills, lower backache, aches in back of legs & thighs, temp 102 per pt;									Y	10/09/1997	10/09/1997	0	according to pt liver enzymes were elevated 13OCT97 & bilirubin was blood;	PUB	UNK		NONE	sinus-not active @ this time	NA~ ()~~~In patient	MD97012	1						1	Back pain; Chills; Hepatic function abnormal; Hyperbilirubinaemia; Myalgia; Nuchal rigidity; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81749~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104131	10/31/1997	MI	49.0	49		F	10/22/1997	approx 48-72 hr p/vax had inc in tenderness, redness & induration @ site in approx 3-4 inch diameter area;									Y	10/13/1997	10/15/1997	2	NA	OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81817~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104093	11/03/1997	NY	85.0	85		M	10/24/1997	reporter does not have any more information on event					Y				U	10/16/1997	10/16/1997	0		UNK	UNK					BAQ020	1						1	Unevaluable event	FLU3~MEDEVA PHARMA, LTD.~E200174C~2~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0104095	11/03/1997	MS	68.0	68		M	10/16/1997	pt recv vax 15OCT97 830 to 930AM & same day died;corner states COD massive MI;	Y	10/15/1997							N	10/15/1997	10/15/1997	0		PUB	UNK	GLynase, Corzide		HTN, diabetes	~ ()~~~In patient	MS97040	1						1	Myocardial infarction	FLU3~MEDEVA PHARMA, LTD.~E3287GB~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0104096	11/03/1997	IL	48.0	48		F	10/28/1997	broke out in hives;breathing diff;h/a went to MD 330PM & was hosp w/IV therapy 1/2hr;				Y	Y	2			Y	10/01/1997	10/01/1997	0	pulsor 98% dx bronchospasm	PUB	PUB		NONE	PCN, tecamycin, environmental allergies;	pt devel h/a @ 47yr old w/hep B dose 3;~ ()~~~In patient	IL97095	1						1	Asthma; Dyspnoea; Headache; Urticaria	FLU3~CONNAUGHT LABORATORIES~4978212~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0104097	11/03/1997	IL	56.0	56		M	09/22/1997	pt reports was at home & had a sudden onset of SOB;pt then went to local ER;BP grossly elevated 230/150;treated for pulmonary edema & released 19SEP97;			Y	Y	Y	1			Y	09/18/1997	09/18/1997	0	NONE	PVT	PUB		NONE	contact dermatis	~ ()~~~In patient	IL97093	1						1	Dyspnoea; Hypertension; Pulmonary oedema	FLU3~PFIZER\WYETH~4978296~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0104099	11/03/1997	MN	60.0	59		F	10/29/1997	14OCT97 pt recv vax & 15OCT97 c/o severe arthralgia/myalgia;16OCT97 pain in chest area upon inspiration;17OCT97 c/o nausea, c/o dehydration, nausea, chills but afeb;WBC 4900;dx dehydration poss rxn to flu vax;t103;back pain,vomit, dizziness				Y	Y				Y	10/14/1997	10/15/1997	1	CBC w/diff was nl	PVT	PVT			Known allergy to sulfa	~ ()~~~In patient		1						1	Arthralgia; Asthenia; Back pain; Bronchitis; Cough; Leukocytosis; Otitis media; Sinusitis	FLU3~CONNAUGHT LABORATORIES~7F81773~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0104100	11/03/1997	PA	40.0	39		F	10/16/1997	5 hr p/vax pt exp chills, t99;that afternoon pt exp numbness of fingers rt hand;numbness to elbow;the next day exp numbness of rt knee & hips;2 days post vax pt exp numbness & tingling in jaw;muscle weakness;CVA;dx GBS;drag leg when walk				Y	Y				Y	10/09/1997	10/09/1997	0	electrocardiogram negative;blood tests negative;CT scan negative;	PUB	PUB	Estrace	NONE		~ ()~~~In patient	897295014L	1						1	Chills; Facial palsy; Gait disturbance; Infection; Myasthenic syndrome; Myelitis; Paraesthesia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4978193~4~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0104101	11/03/1997	TX	35.0	35		M	10/20/1997	pt exp achiness 24hr p/vax;w/in 48hr of vax pt devel bilat leg weakness w/inability to ambulate;pt was hosp on 17OCT97 3 days post vax;			Y	Y	Y				U	10/13/1997	10/14/1997	1		PVT	PVT	NONE	NONE		~ ()~~~In patient	897296029L	1						1	Gait disturbance; Guillain-Barre syndrome; Hypokinesia; Myalgia; Myasthenic syndrome; Paralysis	FLU3~PFIZER\WYETH~4978171~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0104261	11/03/1997	CA	57.0	57		F	10/29/1997	pt recv flu vax 7PM tongue started to swell rt side can only relate to vax this AM swelling gone;									Y	10/28/1997	10/28/1997	0	NA	PUB	OTH	NONE	NONE	NONE	pt exp arm sore w/flu vax;~ ()~~~In patient		1						1	Tongue oedema; Tongue oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~2	USA		Influenza
0104262	11/03/1997	IL	29.0	29		M	10/30/1997	29OCT began exp high fever, sweat, T103, feel dizzy, lightheaded, h/a, twinges in stomach, no appetite;									N	10/29/1997	10/29/1997	0	NONE	OTH	OTH	NONE	nONE	hayfever-allergic to PCN	NA~ ()~~~In patient		1						1	Abdominal pain; Anorexia; Dizziness; Headache; Hyperhidrosis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104263	11/03/1997	WI	26.0	26		F	10/30/1997	pt recv vax @ 930AM felt some mild itching-went into clinic @ 330PM given epi & nebulizer tx vomited prior to going to clinic was weak & pale-also had diff breathing;MD told pt it was an anaphylactic from flu vax though 5hr p/vax;				Y					Y	10/24/1997	10/24/1997	0	NONE	PVT	OTH	NONE	NONE	smoker	~ ()~~~In patient		1						1	Anaphylactoid reaction; Asthenia; Dyspnoea; Hypersensitivity; Pallor; Pruritus; Vomiting	FLUX~UNKNOWN MANUFACTURER~4978186~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0104265	11/03/1997	WI	72.0	72		F	10/28/1997	pt states had feelings of light-headedness beginning @ 230PM on 22OCT97;began noting itching on buttocks p/dinner 22OCT97;did not began to see red hives until 25OCT97;noted hives on inner arms, inner thighs, chest & trunk;									U	10/22/1997	10/22/1997	0		PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	WI98033	1						1	Dizziness; Pruritus; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4978165~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104266	11/03/1997	MA	48.0	48		M	10/29/1997	pt became will on 22OCT97 w/ fever 102 & swelling RUA was seen in the ER on Wednesday & was started on IV ATB x 4 days & PO ATB x 5 days;dx cellulitis rt upper arm;				Y					Y	10/21/1997	10/22/1997	1	NONE	PUB	PUB	Insulin, BP meds, Acupril	NONE	diabetic, inc BP-NKA;	NONE~ ()~~~In patient	MA9721	1						1	Cellulitis; Injection site oedema; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81793~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0993E~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0104271	11/03/1997	TX	73.0	73		F	10/03/1997	late evening on 1OCT97 lt arm began hurting, was swollen, hot & red stayed this way for 2 days;instructed to use cool packs for 10min off & on;go to MD if gets worse;									Y	10/01/1997	10/01/1997	0		PUB	PUB	unk	NONE		~ ()~~~In patient	TX97137	1						1	Oedema peripheral; Pain; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3297GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0332D~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0104272	11/03/1997	TX	68.0	68		F	10/03/1997	late evening on 2OCT97 felt like running fever, rt arm inc red, swollen, hot to touch over 3/4 of upper arm;still hot swollen & red on 3OCT97;recommended cool packs for 10min @ a time off & on rest of day;									Y	10/02/1997	10/02/1997	0		PUB	PUB	unk	NONE	pt is on 02 most of time;	~ ()~~~In patient	TX97136	1						1	Oedema peripheral; Pyrexia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3297GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0332D~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0104273	11/03/1997	TX	75.0	75		F	09/26/1997	about noon on 25SEP97 noted sore arm, hot, swollen, & redness in lt arm over 2/3 of arm; still had sx on 26SEP97;recommended see MD given ATB & told to use cold packs off & on;go back to MD if gets worse;				Y					Y	09/25/1997	09/25/1997	0		PUB	PUB		NONE	NONE	~ ()~~~In patient	TX97135	1						1	Oedema peripheral; Pain; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3297GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0332D~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0104277	11/03/1997	TX	38.0	38		F	10/06/1997	approx 3hr p/vax pt exp watery eyes w/presence of exudate around the eyes, swollen lips, nausea, severe h/a, sore throat, persistent coughing & sneezing & diarrhea that lasted until 8PM or 9PM;the morning of 6OCt97 felt much better;									Y	10/05/1997	10/05/1997	0	NA	OTH	PUB	Antibiotic tx for prev throat infect biaxin & amoxil	NONE	hx short term illness throat infect on 24SEP97	~ ()~~~In patient	TX97131	1						1	Cough; Diarrhoea; Face oedema; Headache; Lacrimal disorder; Nausea; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~7F81803~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104282	11/03/1997	TX	49.0	49		F	09/25/1997	c/o sore throat & itchy eyes & mouth;c/o thick drainage for eyes;had small amount of greenish exudate over rt pupil;VS 110/70, P70, R18;states low BP is nl for pt;25SEP97 2PM pt suffered stomach ache, n/v, chills fever,tinnitis,loss of tast									Y	09/24/1997	09/24/1997	0	NONE	PUB	PUB	NONE	denies illness	denies allergies & pre ecisting conditions-low BP is nl;	NONE~ ()~~~In patient	TX97126	1						1	Abdominal pain; Ageusia; Eye disorder; Pharyngitis; Pruritus; Pyrexia; Tinnitus; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81803~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104283	11/03/1997	TX	57.0	57		M	09/25/1997	nausea, malaise, chills, diarrhea, bone pains & gen weakness lasted approx 48hr;never had gastric sx w/flu shot before;									Y	09/16/1997	09/16/1997	0	NONE	PUB	PUB	ansaid	NONE	Rheumatoid arthritis	NONE~ ()~~~In patient	TX97125	1						1	Asthenia; Bone pain; Chills; Diarrhoea; Gastrointestinal disorder; Malaise; Nausea	FLU3~CONNAUGHT LABORATORIES~7F81803~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104284	11/03/1997	TX	51.0	51		F	09/25/1997	nausea, malaise, chills, diarrhea, bone pains, & gen weakness;lasted about 48hr;never had gastric sx w/flu shot before;									Y	09/19/1997	09/19/1997	0	NONE	PUB	PUB	Prilosec	NONE	ulcers	NONE~ ()~~~In patient	TX97124	1						1	Asthenia; Bone pain; Chills; Diarrhoea; Gastrointestinal disorder; Malaise; Nausea	FLU3~CONNAUGHT LABORATORIES~7F81803~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104290	11/03/1997	TX	33.0	33		F	10/15/1997	red & itchy feet & redness between fingers on hands & onto palms started 5 days p/receipt of flu vax;									U	10/07/1997	10/12/1997	5	NOEN	OTH	UNK	Progesterone suppos	NONE	nONE	~ ()~~~In patient	TX97142	1						1	Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81749~4~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104291	11/03/1997	TX	61.0	61		F	10/15/1997	pt recv vax 8OCT97  & by 11OCT97 pt had fever & swollen arm;by 15OCT97 the site of 1mm was twice as big & red;now it is moving down the arm & it still hurts;									N	10/08/1997	10/11/1997	3		PUB	PUB	taking primerine & Diazide	NONE	PCN taking primerine @ Diazide	~ ()~~~In patient	TX97141	1						1	Injection site hypersensitivity; Oedema peripheral; Pain; Pyrexia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3297GB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~CONNAUGHT LABORATORIES~7B91518~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0104296	11/03/1997	VT	47.0	47		F		pt states arm turned red, swelling up, itching, burn; reporter states 5/8 needle provided by Wyeth for IM flu vax;									Y	10/17/1997			5/8 needle provided by Wyeth for IM flu vax;	OTH	PVT				~ ()~~~In patient		1						1	Oedema peripheral; Pain; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104297	11/03/1997	VT	43.0	43		F	10/28/1997	large reddened, raised area on deltoid, heat filled;ice applied;lasted 4+ days then resolved;spot was also very itchy during rxn;reporter feels the vax was given SC instead of IM because 5/8 needle provided by Wyeth;									Y	10/17/1997	10/18/1997	1		OTH	OTH			allergies-colitis (ulcerative)	~ ()~~~In patient		1						1	Oedema peripheral; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4978193~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104298	11/03/1997	VT	29.0	29		F	10/28/1997	pt arm swelled up turned very hot & red;pt put ice on it;it took 4 days to go back to nl;3 by 4 in wide raised;reporter states pt has large arms there fore 5/8 needle provided on tubex did not go IM;									Y	10/17/1997	10/18/1997	1		OTH	PVT		NONE	NA	NONE~ ()~~~In patient		1						1	Oedema peripheral; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104299	11/03/1997	VT	43.0	43		F	10/23/1997	devel a 4inch x 2inch itchy, hard, red wheal @ site of the inj-varied between locally sore & locally very itchy till today 23OCt97;pt has recv vax other yr including last year w/rxn;reporter states 5/8 needle went SC not IM;									Y	10/17/1997	10/18/1997	1		UNK	UNK	NONE	NONE	PCN	pt exp itchy, hard, red wheal w/flu vax in 1996;~ ()~~~In patient		1						1	Injection site mass; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104300	11/03/1997	VT				F	10/28/1997	large red rash/swelling/itching/hot & was a hard ball where it was given;d/t 5/8 needle provided by Wyeth this inj probably went SC;									Y	10/17/1997	10/17/1997	0		UNK	UNK		NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Oedema peripheral; Pruritus; Rash; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104301	11/03/1997	VT	53.0	53		F	10/28/1997	area about size of a tennis ball that was swollen very red & hot very sore for 3 days;flu vax recv in individual doses from wyeth w/ 5/8 needle;									Y	10/17/1997	10/18/1997	1		OTH	UNK		NONE		~ ()~~~In patient		1						1	Oedema; Pain; Skin nodule; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104302	11/03/1997	VT	40.0	40		F	10/24/1997	rt upper arm, deltoid area became hot to touch w/tenderness, along w/a hard raised rash of 3 inches in circumference around the inj site;reporter states flu vax provided by Wyeth tubex prepared w/ 5/8 for Im shot;									Y	10/20/1997	10/20/1997	0		OTH	OTH	NONE	NONE	NA	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Pain; Vasodilatation	FLU3~PFIZER\WYETH~~1~SC~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104303	11/03/1997	MS	63.0	63		F	10/27/1997	23OCT97 PM did not sleep well;both arms sore;24OCT AM laid in bed all day;rt arm more sore;24OCT97 PM chills, T102;took advil temp inc 103;ached all over;rt arm red, hot, swollen, 3 circle w/itching @ site;25OCT felt better; T102;arm red									U	10/23/1997	10/24/1997	1	NONE	PUB	PUB	advil, alieve, xanax;DPH	NONE	pollen, strawberries, house dust, shrimp, trees, grass, hair, dog, mold, tetanus, horse serum, mitrial valve prolapse, sulfar;	pt exp red, swollen, hot arm @ scratch site test @ 21yr old w/tetanus dose 1;~ ()~~~In patient		1						1	Chills; Injection site hypersensitivity; Injection site oedema; Insomnia; Myalgia; Pruritus; Pyrexia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E32870B~7+~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0585D~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0104305	11/03/1997	CA	49.0	49		F	10/25/1997	arm swelled & had red ring around it;throat swelled;had real bad h/a;felt sick @ stomach;had shot Thursday started to feel better on Tuesday of next week;arm still a little sore;									Y	10/16/1997				PUB	UNK		NONE	NONE	~ ()~~~In patient		1						1	Dyspepsia; Headache; Laryngospasm; Oedema peripheral; Pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104306	11/03/1997	FL	67.0	67		M	10/21/1997	upper lip began swelling 1 1/2hr p/taking flu shot;was cutting grass @ the time;zyrtec given w/resolution;				Y					Y	10/09/1997	10/09/1997	0	NA	PVT	PVT			allergic asthma;HTN;dyslydiotic eczema;	~ ()~~~In patient		1						1	Face oedema	FLU3~MEDEVA PHARMA, LTD.~E32676A~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0104307	11/03/1997	WA	55.0	55		F	10/21/1997	eyes began itching approx 4hr p/vax;2PM 20OCT itching on face w/a few raised rash areas began evening 20OCT;eyes puffy w/facial itching 21OCTAM;pink macular pap rash areas on face & neck;raised area devel w/itching;									Y	10/20/1997	10/20/1997	0		UNK	UNK	Premarin; Day pro;Plaquil;	NONE	allergies: pollen (trees, grasses, plants);perfumes;dx auto immune synd;undifferentiated;	NONE~ ()~~~In patient		1						1	Face oedema; Pruritus; Rash; Rash maculo-papular; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81868~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104308	11/03/1997	NC	68.0	68		M	10/27/1997	severe tendonitis (arms, wrists, shoulders, ankles) w/joint immobility & pain-inability to close/use hands/wrists;closing of containers/doors/drawers painful;viral infect;				Y					N	10/18/1996	11/01/1996	14		PUB	PUB		NONE	malformed lt ear (birth defect) no connection;	~ ()~~~In patient	NC97109	1						1	Arthropathy; Hypokinesia; Infection; Pain; Tendon disorder	FLU3~PFIZER\WYETH~4968166~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~436824~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0104309	11/03/1997	NJ	63.0	63		F	10/24/1997	shakes-couldn't get warm then 105 fever;vomiting;				Y					Y	10/10/1997	10/11/1997	1	bloodwork;tetanus intervenoux	OTH	UNK	Cardizen;Zocor	NONE	heart blockage	~ ()~~~In patient		1						1	Chills; Pyrexia; Tremor; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0104310	11/03/1997	VA	92.0	92		F	10/24/1997	soreness lt arm 1 day p/vax lasting over 5 days;									Y	10/15/1997	10/16/1997	1	NONE	PVT	PVT	Procardia, atenolol, ecotrin	NONE	coronary artery disease, HTN, arthritis, pacemaker	~ ()~~~In patient		1						1	Myalgia	FLU3~PFIZER\WYETH~4978145~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~442521~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0104311	11/03/1997	IL	66.0	66		F	10/15/1997	c/o not feeling good p/vax;also feeling faint & dizzy & numbness rt deltoid muscle;pt to hosp 11OCT97 paramedic on 13OCT97 pt states OK  was not given anything was told by ER;pt just nervousness & hyperventilating;				Y					Y	10/11/1997	10/11/1997	0		OTH	UNK				~ ()~~~In patient		1						1	Dizziness; Hyperventilation; Injection site hypersensitivity; Malaise; Nervousness; Paraesthesia	FLU3~PFIZER\WYETH~4978168~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1648D~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0104312	11/03/1997	OH	35.0	35		F	10/27/1997	@ 11:45 pt recv vax & had burning & pain immed then had back pain & lt shoulder pain;around 1PM felt funny & had SOB but didn't require any intervention;also had some warm & cold feeling;no rxn to prev doses of flu vax in prev years;									Y	10/27/1997	10/27/1997	0	NONE	PUB	UNK	NONE	NONE	codeine allergy	NONE~ ()~~~In patient		1						1	Back pain; Chills; Dyspnoea; Malaise; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4978190~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104313	11/03/1997	AR	64.0	63		M	10/28/1997	pt c/o gen aching/chills accompanied w/SOB 5hr p/vax awoke next AM w/hives covering entire body;states hx some episode hives related to fever or illness;sx resolved 48-72hr;									Y	10/22/1997	10/27/1997	5	NONE	PUB	PUB	NONE	NONE	hx episode hvies r/t fever or illness;	~ ()~~~In patient	AR9787	1						1	Chills; Dyspnoea; Myalgia; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81803~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104314	11/03/1997	AR	56.0	56		M	10/28/1997	12hr p/vax pt devel hives begin on trunk spreading to upper & lower extremities;self rx'd DPH;resolved 3hr later;pt denies allergy to egg/products;however has had allergic rxn in past to undetermined food product;									Y	10/27/1997	10/27/1997	0	NONE	PUB	PUB	NONE	NONE	allergic rxn in past to undetermined food product	NONE~ ()~~~In patient	AR9786	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81803~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104315	11/03/1997	MA	72.0	72		F	10/23/1997	pt recv vax 16OCT97 & 18OCT arm hurt, visited hosp ER 20OCT97;dx tendonitis lt arm told to take pain killers & put arm in sling;23OCT97 arm still sore, radiated down back of hand & up over shoulder;told to see own MD;				Y					Y	10/16/1997	10/18/1997	2		PUB	PUB		NONE	unk	NA~ ()~~~In patient	MA9710	1						1	Pain; Tendon disorder; Insomnia; Myalgia	FLU3~CONNAUGHT LABORATORIES~7F81793~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0104316	11/03/1997	OK	62.0	62		F	10/20/1997	rash that began @ site of vax & spread to chest, abd, & upper arms & between legs which itches which began Thursday evening;tx took DPH for itching;									Y	10/15/1997	10/20/1997	5	NONE	PUB	PUB	Ibuporfen;Synthroid;Diazide;meva coret mult	new BP med	high Bp;arthritis	NONE~ ()~~~In patient	OK9735	1						1	Injection site hypersensitivity; Pruritus; Rash	FLU3~MEDEVA PHARMA, LTD.~E32776A~7+~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104317	11/03/1997	OK	37.0	37		F	10/23/1997	pt recv vax 22OCT97;approx 430-5PM reports lt arm began to swell & become painful 9PM;lt arm more swollen;hot & cold chills;fever;cont through noc;23OCt97 920AM saw pvt MD dx w/bacterial infect;				Y					Y	10/22/1997	10/22/1997	0	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	OK9734	1						1	Chills; Infection; Insomnia; Oedema peripheral; Pain; Pyrexia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3277GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0906E~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0104318	11/03/1997	OK	65.0	65		F	10/22/1997	hives in arm pits;along waist & @ wrists & possible clear blisters in back of throat;has hayfever took DPH last noc & today @ noon which improves the situation;									Y	10/15/1997	10/21/1997	6	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	OK9736	1						1	Dermatitis bullous; Mucous membrane disorder; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E3277GA~2~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104319	11/03/1997	AL	57.0	57		M	10/28/1997	8:40 vax given 10AM mild urticaria by report;12noon severe urticaria, w/eruption of small hives on neck-pt took DPH;1PM sx advanced to large hives covering face, neck, head, chest & trunk;on site clinic administered DPH;				Y					Y	10/24/1997	10/24/1997	0	NONE	OTH	OTH	Accupril	NONE	allergy to ASA-Naproxen-hayfever;HTN	NONE~ ()~~~In patient		1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81856~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0104320	11/03/1997	NY	30.0	30		F		pt recv vax & felt pain underarm;pt underarm glands felt swollen;									U	10/14/1997	10/30/1997	16	NONE	OTH	PUB	Birth Control-pills	NONE	NONE	~ ()~~~In patient	BAM021	1						1	Lymphadenopathy; Pain	FLU3~MEDEVA PHARMA, LTD.~E20017HC~2~A~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0330D~2~A~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0104322	11/03/1997	NY	68.0	68		F	10/23/1997	pt felt hard lump @ the site where pt recv vax;also reported that the lump appeared red;				Y					Y	10/21/1997	10/22/1997	1	NONE	OTH	PUB	unk	NONE	NONE	~ ()~~~In patient	BAB019	1						1	Injection site hypersensitivity; Injection site mass	FLU3~MEDEVA PHARMA, LTD.~E10017HC~2~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0815D~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0104323	11/03/1997	NC	62.0	62		F	10/21/1997	redness & sl edema @ inj site lt deltoid area also very warm to touch;									Y	10/18/1997	10/19/1997	1	NONE	OTH	PUB	NA	NA	NONE	~ ()~~~In patient	NC97106	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20017H~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~436770~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0104331	11/03/1997	OR	23.0	23		F	10/31/1997	rash, itching, sore, swollen/head, face, chest;									Y	10/24/1997	10/25/1997	1		PVT	UNK		NONE	NONE	~ ()~~~In patient		1						1	Face oedema; Headache; Oedema; Pain; Pruritus; Rash	FLU3~PFIZER\WYETH~4978154~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104335	11/03/1997	IL	53.0	53		M	10/14/1997	Saturday noc 11OCT97 ran 104 fever x 6 hr;fever broke around 11Pm Saturday noc;ran fever again Sunday noc-not as high;fever free Monday & felt well enough to go to work;no other sx other than fever;									Y	10/10/1997	10/11/1997	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	IL97094	1						1	Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E32876H~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104337	11/03/1997	CA	43.0	43		F	10/24/1997	rxn occurred 3 days p/vax;s/sx 3 red stripes radiating down from inj site rt deltoid to the lt hand fingers & chest area;c/o pain & swelling @ inj site;T103 for 2 days w/ n/v & some trouble breathing;rash all over;				Y					Y	10/15/1997	10/18/1997	3		OTH	PUB				~ ()~~~In patient	CA970088	1						1	Dyspnoea; Injection site oedema; Injection site pain; Pyrexia; Rash; Skin striae	FLU3~CONNAUGHT LABORATORIES~7F81841~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0104338	11/03/1997	CA	61.0	61		F	10/20/1997	by 5PM that noc pt arm was red-swollen & warm;took 2 days to feel better;on 20OCT97 arm had few hard areas but redness was gone;									Y	10/16/1997	10/16/1997	0		PUB	PUB		NONE	NONE	NONE~ ()~~~In patient	CA970087	1						1	Oedema peripheral; Skin nodule; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81841~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0845D~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0104339	11/03/1997	CA	36.0	36		F	10/23/1997	pregnant pt recv vax & later pt exp fetal demise @ hosp;pt felt that may have been caused by flu shot;										10/15/1997			autopsy & micron placenta done;	PUB	PUB	Prenatal vitamins	unk	NKA, No known condition	unk~ ()~~~In patient	CA970086	1						1	Foetal disorder; Foetal disorder	FLU3~CONNAUGHT LABORATORIES~7F81841~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7F81841~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0104340	11/03/1997	CA	70.0	70		F	10/16/1997	n/v, chills, x 5hr;no treatment administered;									Y	10/15/1997	10/16/1997	1	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	CA970085	1						1	Chills; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81841~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104341	11/03/1997	CA	68.0	68		M	10/09/1997	7OCT97 approx between 6 & 8PM, flushed face, sore lt arm, uncomfortable sleeping on it per pt statement;8OCT97 h/a, fever, redness & swelling of entire back of lt arm;9OCT swelling extending to approx 4 below elbow;redness of all edematous									Y	10/07/1997	10/07/1997	0	NA	PUB	PUB	testerone inj;beconase inhaler	NONE	unk	NA~ ()~~~In patient	CA970084	1						1	Headache; Injection site pain; Insomnia; Oedema peripheral; Osteoarthritis; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F818411~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0845D~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0104342	11/03/1997	CA	75.0	75		F	10/10/1997	approx 5hr p/vax pt became SOB, had chills, achiness & malaise lasting until 10OCt97 when went to hosp ER approx 10AM;dx UTI;given ATB, had rxn to sulfa;				Y					Y	10/08/1997	10/08/1997	0	blood work	PUB	PUB	allegra	poss UTI		~ ()~~~In patient	CA970083	1						1	Chills; Condition aggravated; Dyspnoea; Hypersensitivity; Malaise; Myalgia; Urinary tract infection	FLU3~CONNAUGHT LABORATORIES~7F81841~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0104343	11/03/1997	MN	90.0	90		M	10/28/1997	12OCT c/o pruritic back area;13OCT c/o itchy & red w/a rash;14OCT 2:35 overall body rash, raised, deep pink to red in color, ankle swelling;14OCT;ache all over;t100.2;skin pain on chest & abd;?thimerisol allergy;							Y		Y	10/09/1997	10/12/1997	3		MIL	PVT	Lanoxin, Colace, Pepcid, Cardizem, ASA, Estar Gel	Ataxia secondary trahsichemic attacks	allergy to sulfa, severe psoriasis	~ ()~~~In patient		1						1	Hypersensitivity; Oedema peripheral; Pain; Pruritus; Pyrexia; Rash; Rash maculo-papular	FLU3~PFIZER\WYETH~4978203~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0104345	11/03/1997	FL	52.0	52		M	10/31/1997	2hr p/vax devel a sore throat & flu sx (weakness, dizziness, aches ect) which lasted about 12hr;mouth, gums & inter nose devel a burning sensation which lasted for 1 day;eyes teared up for about 4 to 6 hr;									Y	09/25/1997	09/25/1997	0	NOEN	OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Dizziness; Influenza; Lacrimal disorder; Myalgia; Pharyngitis; Stomatitis	FLU3~CONNAUGHT LABORATORIES~7F81817~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104346	11/03/1997	TX	45.0	44		F		heart racing lasted 1min on 12OCT97;arm red, swollen, hot & hard;heart racing x 2 lasting 1min each time 13OCt97;pt threw up & had stomach cramps on 13OCt97;called MD office given DPH & hot & cold pads to apply locally on the arm;									Y	10/12/1997	10/12/1997	0	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	VA9718	1						1	Abdominal pain; Oedema peripheral; Skin nodule; Tachycardia; Vasodilatation; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81894~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104103	11/04/1997	FL	70.0	70		M	11/03/1997	pt recv vax 5OCT97 about 7 days later 12OCT97 pt exp sx of a stroke;pt was hosp;f/u conversations w/the initial report 2NOV97 indicated that in all probability the stroke was not associated w/flu vax;pt was reported as d/c from hosp;					Y				Y	10/05/1997	10/12/1997	7		OTH	PVT		none	allergies to penicillin and shell fish	~ ()~~~In patient	CO7688	1						1	Cerebrovascular accident	FLU3~CONNAUGHT LABORATORIES~7F81831~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0104357	11/04/1997	MA	47.0	47		F	10/30/1997	rash all over back, spread to all over trunk, face, arms, chest;30OCT still have some rash on face-very itchy & uncomfortable;				Y					Y	10/25/1997	10/27/1997	2	NONE	PVT	OTH	Esteo tabs;Bacteim;Provocol;Ativan;		allergies to morphine, tavist-D & seldane;	~ ()~~~In patient		1						1	Pain; Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0104358	11/04/1997	WA	48.0	47		F	10/30/1997	hives or rash which itches on scalp, face, stomach, back, legs hands;									N	10/21/1997	10/27/1997	6	NONE	OTH	OTH	aspirin for h/a	flu-like sx w/o fever	NONE	~ ()~~~In patient		1						1	Pruritus; Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104359	11/04/1997	GA	65.0	65		M	10/31/1997	swelling almost immed inc in PM-lt upper arm erythema prominent shoulder to elbow-cont discomfort, low grade fever, swelling cont to inc, painful;									Y	10/29/1997			NONE	PUB	OTH	NONE	NONE	unk	~ ()~~~In patient		1						1	Oedema peripheral; Pain; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0104362	11/04/1997	NY	77.0	77		F	10/28/1997	diffuse, 2-3cm circular patchy flat erythematous lesions scattered in extensor surfaces of arms;no blanching w/pressure;appeared 1 day p/flu shot;stiff present on 27OCT97;pt used hydrocortisone;				Y					Y	10/20/1997	10/21/1997	1		PVT	PVT	Fosamax, amitiptiyline, focor, HCTZ	NONE	sulfa	~ ()~~~In patient		1						1	Rash maculo-papular	FLU3~PFIZER\WYETH~4978144~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104364	11/04/1997	CA	76.0	75		F	10/26/1997	5hr p/vax lt shoulder, redness, pain, & swelling 2 days later swelling moved to elbow;										10/24/1997	10/24/1997	0	NONE	PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Oedema peripheral; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81898~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1173E~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0104365	11/04/1997	TX	17.0	17		F	10/24/1997	22OCT97 rt arm swelling/bruising w/sore hives;no distress;rx ice, motrin, DPH PRN;									U	10/21/1997	10/22/1997	1	NONE	PVT	PVT	NONE	NONE	NOV94 varicella;MAR95 hosp w/pneumonia	~ ()~~~In patient		1						1	Ecchymosis; Oedema peripheral; Pain; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81852~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~445636~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0104366	11/04/1997	NC	62.0	62		F	10/26/1997	hives on inside of both arms;welts about 12hr p/vax;cold compress used;gone w/in 8hr;									Y	10/17/1997	10/17/1997	0	NONE	PUB	OTH	premin-vitamins	NONE	allergic to PCN, allergic to aleve (hives), no other	NONE~ ()~~~In patient		1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104368	11/04/1997	MI	29.0	29		F	10/27/1997	lump, quarter in size, hard, red;									Y	10/24/1997	10/25/1997	1	NONE	PVT	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Skin nodule; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81723~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TTOX~CONNAUGHT LABORATORIES~7C91556~1~IM~GM~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0104370	11/04/1997	MD	42.0	42		F	10/30/1997	pt recv vax 20OCT97 & 6PM had red rash & itchy over upper torso (chest, back, arms, neck & face);rash cont till Thursday when it was replaced by discreet spots particularly on upper chest;rash & itching resolved by Saturday;									Y	10/20/1997	10/20/1997	0	NA	OTH	UNK	NONE	NONE	allergies to grass, trees, weeds, molds, mites	~ ()~~~In patient		1						1	Pruritus; Rash; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104371	11/04/1997	TX	52.0	52		F	10/24/1997	had chills that noc p/vax woke up nauseated, vomited then vomited 4-5 times throughout the day;had major muscle aches that AM;called by MD phoned in prescription for phenergan suppository;cont to have muscle aches;cont w/muscles aches;									Y	10/21/1997	10/22/1997	1	NA	PUB	PVT	Insulin AM & PM;capatril for HTN	NONE	diabetes, hypertension, back injury	NA~ ()~~~In patient		1						1	Chills; Myalgia; Vomiting	FLU3~PFIZER\WYETH~4978139~5~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104374	11/04/1997	MI	37.0	37		F	10/30/1997	felt pressure in rt hand (fingers);then metallic taste in mouth;sore throat;lightheadedness, nausea (very brief) then red, itchy rash on fore arms, dry mouth, sore throat & metallic taste in mouth;				Y					Y	10/30/1997	10/30/1997	0	NONE	OTH	PVT		NONE		pt mother exp rxn p/flu vax dose 1;~ ()~~~In patient		1						1	Dizziness; Dry mouth; Dysgeusia; Nausea; Pain; Pharyngitis; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~7F81761~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0104379	11/04/1997	MI	63.0			F	10/31/1997	local reddened area lt arm;									Y					PVT	PVT	pt recv pneumoni immune vax 31OCT97 lot# 935434;	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~7F81745~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~UNKNOWN MANUFACTURER~7C91556~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0104392	11/04/1997	MI	34.0	34		U		pt recv vax 4NOV97 1045AM & pt c/o diff swallowing, feels like throating closing @ 11AM:BP 122/90 denied any allergies, given DPH;auscultated all obese;pt advised to be seen in ER;inc fluids;				Y					Y	11/04/1997	11/04/1997	0	NONE	OTH	PVT	NONE			NONE~ ()~~~In patient		1						1	Dehydration; Dysphagia; Laryngospasm	FLU3~PFIZER\WYETH~4978212~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104251	11/05/1997	CA	74.0	74		F	11/02/1997	pt recv vax -soreness in arm & sl coughing woke up next day extremely ill-coughing;sneezing, flu sx, fever, chest congested, nasal congestion, very ill;			Y						Y	10/29/1997	10/29/1997	0	NONE	PVT	OTH	Multivitamins;Bioptic-prevent glaucoma;cholesterol med, med for osteoporesis;	NONE	cholesterol, osteoporesis;	1994 pt exp flu synd & 71yr old w/flu vax unk dose;~ ()~~~In patient		1						1	Cough; Influenza; Malaise; Pain; Pharyngitis; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0104253	11/05/1997	MD	71.0	71		M	11/04/1997	presented on 4NOV @ 926AM immed care w/ SOB, weakness, cyanotic, pallor, swelling lt arm-lateral forearm to hand;swollen since inj;T96.8;expired 4NOV97 @ home;	Y	11/04/1997		Y					N	10/28/1997	10/28/1997	0	refused lab work	PUB	PUB	NONE	NONE	hx ETOH, tobacco use;	~ ()~~~In patient		1						1	Asthenia; Cyanosis; Dyspnoea; Hypothermia; Oedema peripheral; Pallor; Asthenia; Cyanosis; Dyspnoea; Hypothermia; Oedema peripheral; Pallor; Apnoea; Asthenia; Cyanosis; Dyspnoea; Hypokinesia; Hypoxia; Malaise; Oedema peripheral; Asthenia; Cyanosis; Dyspnoea; Hypoxia; Oedema peripheral; Pallor	FLU3~MEDEVA PHARMA, LTD.~E20017HC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~441214~1~IM~RA~PNEUMO (PNU-IMUNE)~1|FLU3~MEDEVA PHARMA, LTD.~E20017HC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~PFIZER\WYETH~441247~1~IM~RA~PNEUMO (PNU-IMUNE)~2|FLU3~MEDEVA PHARMA, LTD.~E20017HC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~3|PPV~PFIZER\WYETH~441249998~UNK~IM~~PNEUMO (PNU-IMUNE)~3|FLU3~MEDEVA PHARMA, LTD.~E20017HC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~4|PPV~PFIZER\WYETH~441247~1~IM~RA~PNEUMO (PNU-IMUNE)~4	USA	Results in Death	Influenza
0104256	11/05/1997	MN	73.0	73		M	10/29/1997	pt adm to hosp p/emesis & syncope @ home;recv flu vax 2PM on 23OCT97;c/o not feeling well @ home around 7PM; 1 day hosp stay & d/c to home;				Y	Y	1			Y	10/23/1997	10/23/1997	0	24OCT97 WBX 16.8;	PVT	PVT	ASA, Isordil, Calan SR	UNK	NONE	NONE~ ()~~~In patient		1						1	Leukocytosis; Malaise; Syncope; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81803~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0104257	11/05/1997	CO	47.0	47		F	10/30/1997	pt recv vax 23OCT97 & 5 days later sudden onset of acute lt arm numbness & weakness & pain from triceps down-has to think to move arm;MD suspects post vax plexus inflammation;				Y	Y		Y		U	10/23/1997	10/28/1997	5	WBC 7.2;PH 204;Na/K+ 142/3.8;CXR ok;EKG WNL SR;URI WNL;	PUB	PVT	Prozac	healthy	codeine	NA~ ()~~~In patient		1						1	Coordination abnormal; Hypokinesia; Laboratory test abnormal; Myasthenic syndrome; Neuropathy; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4978206~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0104258	11/05/1997	CA	74.0	74		F	10/31/1997	4hr p/vax pt devel high fever, became comatose, paramedics to ED w/T104l3 R, p160, R20, s/s of MI;			Y	Y	Y				Y	10/28/1997	10/28/1997	0	lytes WNL, cult (blood/urine) negative;	PVT	PVT	Phenytoin, Phenobarb, Verapamil SR	?	Carbamazepine	unk~ ()~~~In patient		1						1	Coma; Myocardial infarction; Pyrexia; Tachycardia	FLU3~CONNAUGHT LABORATORIES~7F8182~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~441213~UNK~~RA~PNEUMO (PNU-IMUNE)~1	USA	Life Threatening,Hospitalisation	Influenza
0104259	11/05/1997	MN	65.0	65		F	10/29/1997	devel diff breathing, wheezing, throat felt like it was closing;pt presented to area clinic 2:30 & was treated w/Rocepinephrine nebulizer & albuterol nebulizer, 02, valium, morphine;transported via amb to hosp dx anaphylaxis;kept in hosp 1d				Y	Y	1			Y	10/28/1997	10/29/1997	1	NONE	PVT	PVT	Procardia, cardizem, kdur, lasix, premarin, quinidex, ASA	unk	NONE	NONE~ ()~~~In patient		1						1	Anaphylactoid reaction; Asthma; Dyspnoea; Laryngospasm	FLU3~CONNAUGHT LABORATORIES~7F81803~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0104383	11/05/1997	NY	80.0	79		F	11/04/1997	pt recv vax & exp Bell's palsy 3 days p/vax;f/u info indicated that pt had lt facial droop 2 days p/vax & sx persist about 2wk;MD indicated that doubted but was not sure that sx caused by flu vax;									N	10/08/1997	10/11/1997	3	investigation included thyroid function, B12 & folate & lyme disease latter was negative;	OTH	OTH	Colace/docusate sodium;sizc/ziac	HTN	hx of hypothyrodism, breast cancer, mild valvular heart disease;HTN	~ ()~~~In patient	MPI97759	1						1	Anxiety; Facial palsy; Hypotonia	FLU3~MEDEVA PHARMA, LTD.~E3317GH~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104384	11/05/1997	AZ	55.0	54		F	11/04/1997	where flu & pneumonia arm swelled, got red & hot, felt sick, chills, felt awful;next day worse-arm redder-swelling inc to 6 hurt on inside of arm & chest wall, fever 101.1, h/a, pain;all joint hurt,sleep in 2hr stretches;diarrhea;										10/31/1997	10/31/1997	0		PUB	OTH	unk	unk	hx 2 MI's	NA~ ()~~~In patient		1						1	Chest pain; Diarrhoea; Headache; Injection site hypersensitivity; Injection site oedema; Malaise; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0104385	11/05/1997	CA	58.0	58		F		evening p/flu vax pt devel h/a, blinding h/a hurts all over;should cont to get flu shot in the future;flu sx, nose running, cold sx, fever, eyes hurt;									U	11/01/1997	11/01/1997	0		PUB	OTH	unk	NONE	asthma-chronic bronchial condition	~ ()~~~In patient		1						1	Eye pain; Headache; Influenza; Myalgia; Pharyngitis; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104387	11/05/1997	IA				U		sx started 2hr p/vax lasted 4 days;h/a, dizzy, blurred vision, plugged sinuses, weak, shaky, chills, no fever;thinks had sinus infect;									N	10/27/1997	10/27/1997	0	NA	PUB	PUB		think-sinus infect	NONE	NONE~ ()~~~In patient	IA97043	1						1	Amblyopia; Asthenia; Chills; Dizziness; Headache; Infection; Sinusitis; Tremor	FLU3~CONNAUGHT LABORATORIES~7F81724~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104388	11/05/1997	MD	49.0	49		F	10/28/1997	pt stated that had a reddened, hot area, lt upper arm;measured approx 3-4 in width;devel lt arm stiffness which spread to lt upper back & lt side of neck;stated couldn't lay on rt side or lt lt arm very high;c/o aching deep inside lt arm				Y					U	10/24/1997	10/25/1997	1	NONE	UNK	UNK	NONE	NONE	allergies;Novocaine & nitrous oxide;	NONE~ ()~~0.00~Patient	MD97015	1						1	Hypokinesia; Hypotonia; Injection site hypersensitivity; Myalgia; Nuchal rigidity; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81791~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0104390	11/05/1997	WI	26.0	26		F	10/30/1997	a few hr p/vax pt had diffuse pain, swelling w/o redness (local rxn);				Y					Y	10/29/1997	10/29/1997	0	NONE	PVT	PVT	ALbuterol & florent inhaler	asthma	asthma;	NONE~ ()~~~In patient		1						1	Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81817~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0104391	11/05/1997	TX	29.0	28		F	11/03/1997	pt recv vax 13OCT97 & stated itched all over told to come to med office & had reddened area all over body w/itching & rt deltoid are where vax given reddened;				Y					Y	10/13/1997	10/13/1997	0	17OCT97 CBC, UA, SMAC, ESR negative;	PVT	PVT	Darovocet;	NONE	allergic to PCN, mayline, sulfa;	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Rash	FLU3~PFIZER\WYETH~4978143~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104393	11/05/1997	MI	45.0	45		F	10/16/1997	pt c/o itchy throat, throat closing & itchy all over 5min p/vax  prior BP 122/90 BP p//vax 160/100;given DPH & epi;				Y					Y	10/16/1997	10/16/1997	0		OTH	PVT	NONE	NONE	codeine	~ ()~~~In patient		1						1	Hypertension; Laryngospasm; Pharyngitis; Pruritus	FLU3~PFIZER\WYETH~4978163~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104398	11/05/1997	MD	45.0	45		F	10/30/1997	pt described menthol-like taste in mouth during administration of vax;c/o throat tightness & burning;pt observed for 1/2hr;condition improved;no other intervention given;pt advised to f/u w/pvt MD;									Y	10/29/1997	10/29/1997	0	NONE	OTH	PVT	unk	NONE	subsequent to rxn, pt related had an allergic rxn to anesthesia;	unk~ ()~~~In patient		1						1	Dysgeusia; Laryngospasm; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~7F81754~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104399	11/05/1997	TX	39.0	39		M	10/28/1997	15OCT97 pt recv vax & 22OCT97 noticed eruption to lt hand,neck, rt FA, also nauseated;23OCT97 seen by MD;28OCT eruptions still present w/nausea;				Y						10/15/1997	10/22/1997	7	NA	UNK	UNK	PPD by Connaught lot# 245911 given 15OCT97;	NONE	allergic to codeine-Talwin secondary to hayfever;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Nausea; Rash	FLU3~PFIZER\WYETH~4978139~2~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104400	11/05/1997	OR	45.0	45		F	10/13/1997	had inj @ 10:30, c/o lower lip swelling & chest tightness # 12:30-1PM;									Y	10/13/1997	10/13/1997	0		PUB	OTH	Proventil, HCTZ, Verapamil;	NONE	asthma, animal dander, dust, bird feather;inc BP	~ ()~~~In patient		1						1	Chest pain; Face oedema	FLU3~PFIZER\WYETH~4978213~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104404	11/05/1997	AZ	32.0	32		F	10/15/1997	pt recv flu vax & site of inj w/in 3hr became swollen, warm & tender to touch;									Y	10/15/1997	10/15/1997	0	NA	UNK	UNK		denies		~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4978142~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104406	11/05/1997	WA	41.0	41		M	10/20/1997	24hr later devel redness, pain, swelling 8x12cm area over mid lateral upper arm;									U	10/15/1997	10/16/1997	1		OTH	UNK	Beconase AQ;Allegra	NONE	sulfa	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~7F81726~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104408	11/05/1997	MA	51.0	51		F	10/27/1997	throbbing h/a especially behind eyes 24hr duration;vomiting 12hr duration;low back pain x 3 days;									Y	10/16/1997	10/16/1997	0		PVT	UNK		NONE	NONE	h/a, vomiting @ 18 w/flu dose 1;~ ()~~~In patient		1						1	Back pain; Eye pain; Headache; Vomiting	FLU3~PFIZER\WYETH~4978270~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104410	11/05/1997	NY	46.0	46		F	10/28/1997	sl fever 100.5, noc sweats, joint pain-knees, elbow, severe pain both legs;temp swings 98.1-99.8 over couple days;had trouble sitting, standing-leg pain severe 21OCT-24OCT97;pt states had allerg rxn w/aleve-rash, itching;									Y	10/15/1997	10/21/1997	6		PUB	OTH	SUlfamethtrim DS for sinus infect;	told nurse was on sulfa;		~ ()~~~In patient		1						1	Arthralgia; Hyperhidrosis; Hypokinesia; Hypothermia; Pain; Pruritus; Pyrexia; Rash	FLU3~PFIZER\WYETH~4978169~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104411	11/05/1997	CO	19.0	19		F	10/23/1997	erythema, tenderness around vax site devel next day;dx cellulitis;rx warm compresses, course dicloxacillin;				Y					U	10/21/1997	10/22/1997	1	NA	MIL	MIL	NONE	NONE	NONE	~ ()~~~In patient		1						1	Cellulitis; Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4978176~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEPA~MERCK & CO. INC.~0756E~1~IM~~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0104412	11/05/1997	NC	41.0	41		F	10/17/1997	5-6hr p/vax pt exp itching, hives, whelps on trunk & buttocks, thighs;eyes, ears, & head swollen;DPH taken @ time;slept all the next day;									Y	10/08/1997	10/09/1997	1		PUB	UNK	NONE	NONE	arthritis	~ ()~~~In patient		1						1	Face oedema; Oedema; Pruritus; Somnolence; Urticaria	FLUX~UNKNOWN MANUFACTURER~7F81857~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104415	11/05/1997	SD	64.0	64		F	10/29/1997	skin redness & hives w/gen body itching beginning 25OCT97 cont until 27OCT(7 AM; p/1st dose of DPH occasional itching w/few red spots @ waist remain;									Y	10/22/1997	10/25/1997	3	NONE	OTH	OTH	Calcium tabs;Atenolol, Avon woman care;Aprazolam, Pepcid AC	NONE	HTN, GI reflux, depression	unk~ ()~~~In patient		1						1	Pruritus; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4978174~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104416	11/05/1997	HI	39.0	39		M		fever, body aches, malaise, irritability, lightheaded, sinus infect, congestion 4mo duration;				Y					Y	10/29/1991	10/29/1991	0		PVT	PVT	NONE	NA	NA	~ ()~~~In patient		1						1	Agitation; Infection; Malaise; Myalgia; Pyrexia; Rhinitis; Sinusitis	FLU3~PARKE-DAVIS~04161P~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0104417	11/05/1997	WI	52.0	51		F	10/27/1997	awoke @ 4AM 24OCT97 itching all over body;noticed swelling/rash on both legs below knees;rash did extend farther up leg on 25OCT & 26OCT but as of 27OCT AM rash & itching are resolving;used DPH for itching;rash was red, raised not hives;									Y	10/23/1997	10/24/1997	1	nond done	PVT	PVT	Synthroid;proverin-ogen;Maxide	NONE	codeine;HTN, hypothyroidism, hormonal changes;	pt sibling & daughter devel rash & arm swelling @ 21 w/flu vax;~ ()~~~In Sibling		1						1	Oedema peripheral; Pruritus; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~7F81773~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104418	11/05/1997	NJ	60.0	60		F	10/28/1997	immed severe pain & swelling down arm-few days later itching all over body-later rash around mid section;saw allergist;									N	10/10/1997	10/10/1997	0		PUB	PVT		NONE	sulpha-HTN	NONE~ ()~~~In patient		1						1	Oedema peripheral; Pain; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104420	11/05/1997	PA	44.0	44		F	10/28/1997	pt reported sever itching, rash, swelling, SOB, facial numbness 2 days p/vax;seen by MD given pred, atarix for sx;				Y					Y	09/24/1997	09/25/1997	1		OTH	PVT	Lipitor, diovan, pexiat, erythromycin;	NONE	high BP, high cholesterol (med tx for both)	NA~ ()~~~In patient		1						1	Dyspnoea; Oedema; Paraesthesia; Pruritus; Rash	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104421	11/05/1997	IL	55.0	55		F	10/28/1997	pt recv vax & exp rt arm pain radiating to axilla & breast, swollen & gave neck glands;									Y	10/18/1997	10/19/1997	1		PUB	PVT	Synthroid, Premarin	NONE	allergy PCN, ceclor, sulfa, biaxin, duravet, asthma;	NA~ ()~~~In patient		1						1	Chest pain; Lymphadenopathy; Pain	FLU3~CONNAUGHT LABORATORIES~7F81852~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104422	11/05/1997	OH	39.0	39		F		redness in area of inj w/pain in arm;pt seen in clinic for f/u lt deltoid;									Y	10/22/1997	10/24/1997	2		UNK	UNK			diabetes	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Pain	FLU3~PFIZER\WYETH~4978181~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104424	11/05/1997	WA	52.0	52		F	10/24/1997	hip pain, joint pain, rxn in shoulder rt p/ then no rxn;now 10 days p/hip, shoulder pain, significant;				Y					Y	10/13/1997	10/23/1997	10	NA	PVT	OTH	Hormones	NONE		pt exp ache/pain w/last 3 flu shots;~ ()~~~In patient		1						1	Arthralgia; Pain	FLU3~PFIZER\WYETH~4774~5~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~43210~1~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0104425	11/05/1997	CA	74.0	74		F	10/30/1997	vomit,diarrhea, throat & roof of mouth red, fever 100, rash in groin area & up lower abd both sides chapped lips that peeled lost 6 pounds;contacted MD 20OCT-said take DPH antihistamine it helped 30OCCT97 still fell a little weak;									Y	10/16/1997	10/17/1997	1		PUB	UNK	none	NONE	physical 3OCT97 repoort in good hlth	~ ()~~~In patient		1						1	Asthenia; Dermatitis exfoliative; Diarrhoea; Pharyngitis; Pyrexia; Rash; Vomiting; Weight decreased; Asthenia; Dermatitis exfoliative; Diarrhoea; Pharyngitis; Pyrexia; Rash; Vomiting; Weight decreased	FLU3~CONNAUGHT LABORATORIES~7F81841~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7F81841~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0104426	11/05/1997	AZ	26.0	26		F	10/30/1997	localized lt deltoid inflammation;afeb;									Y	10/16/1997	10/17/1997	1	NONE	PVT	PVT	NA	NONE	unk	~ ()~~~In patient		1						1	Injection site inflammation	FLU3~PFIZER\WYETH~4978159~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104427	11/05/1997	OR	26.0	26		M	10/14/1997	1+ swelling of hand & wrist;numbness +3 digit lt hand;DPH given;pt instructed to take DPH;									N	10/14/1997	10/14/1997	0	NONE	OTH	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						1	Oedema peripheral; Osteoarthritis; Paraesthesia	FLU3~PFIZER\WYETH~4978213~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104436	11/05/1997	ID	33.0	33		F	10/28/1997	29hr p/vax pt called w/hives on face, neck & arms;tx w/DPh;pt to go to ER for SOB;use cool compress to hives, T101;									Y	10/23/1997	10/24/1997	1	NA	OTH	PVT	Climara, Estradril, transdermal system, inhalers, seravent, aerobid, maxair		asthma x 5yr, allergy shots as child;	~ ()~~~In patient		1						1	Condition aggravated; Dyspnoea; Pyrexia; Urticaria	FLU3~PFIZER\WYETH~4978208~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104437	11/05/1997	PA	50.0	49		F	10/31/1997	burning in upper arm;very painful weakness in arm;unable to pull up under garments, bed covers or turn the steering wheel w/o a lot of discomfort;										10/16/1997				OTH	OTH		NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Hypokinesia; Pain	FLU3~CONNAUGHT LABORATORIES~7F81860~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104438	11/05/1997	PA	20.0	20		M	10/31/1997	sharp, painful feeling in place where flu was given;arm feels sore & weak;										10/16/1997	10/16/1997	0		OTH	OTH		NONE	NONE	~ ()~~~In patient		1						1	Injection site pain; Myalgia; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~7F81860~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104315	11/06/1997	MA	72.0	72		F	10/30/1997	pt recv vax & devel deep muscle ache of lt arm from upper arm to back of hand;As of 4 days the ache remains in the upper portion all day;worse when legs down @ noc;pt reports MD used big needle;				Y					N	10/16/1997	10/16/1997	0		PUB	UNK		NONE	NONE	NONE~ ()~~~In patient		1						2	Pain; Tendon disorder; Insomnia; Myalgia	FLU3~CONNAUGHT LABORATORIES~7F81793~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0104351	11/06/1997	KS	14.0			M	11/05/1997	pt recv vax 31OCT97 & 5min p/vax pt exp a sz;the pt regained consciousness, was kept in the MD office for 1hr then adm to hosp for observation & EEG eval;					Y	1			Y	10/31/1997	10/31/1997	0	EEG	UNK	UNK				~ ()~~~In patient	CO7689	1						1	Convulsion; Stupor; Syncope	FLU3~CONNAUGHT LABORATORIES~7F81829~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0104352	11/06/1997	CO	33.0			M	11/05/1997	pt recv vax 13OCT97 & 30min p/vax pt exp a severe h/a;2hr later @home pt reportedly became delirious, went unconscious & had fixed, dilated pupils;to hosp & adm to ICU;WBC 19,000;duration of hosp approx 2.5d;facial paresthesia;					Y	3			Y	10/13/1997	10/13/1997	0		UNK	UNK			migraines headaches;	~ ()~~~In patient	CO7690	1						1	Delirium; Headache; Leukocytosis; Mydriasis; Paraesthesia; Pupillary disorder; Syncope	FLU3~CONNAUGHT LABORATORIES~7F81763~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0104353	11/06/1997	KY	43.0			M	10/21/1997	pt recv vax 13OCT97 & 5 days later was hosp dx of atrial fibrillation/flutter;					Y				U	10/13/1997	10/18/1997	5		PVT	PVT	unk	NONE		~ ()~~~In patient	897296015L	1						1	Atrial fibrillation; Atrial flutter	FLU3~PFIZER\WYETH~4978167~3~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0104468	11/06/1997	TX	53.0	53		F	10/27/1997	1 day p/vax fever 98-99 (nl temp for pt runs in 96-97 range;much mucous production nasal & bronchial, coughing, chills, no sleep for 3 days;wheezing, inhalant bronchial dilation every hr;									Y	10/21/1997	10/22/1997	1	NONE	PVT	PVT		NONE	asthma	~ ()~~~In patient		1						1	Asthma; Bronchitis; Chills; Condition aggravated; Cough; Pyrexia; Rhinitis; Somnolence	FLU3~PFIZER\WYETH~4978140~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104469	11/06/1997	ME	38.0	38		M	11/03/1997	lt peripheral (cranial nerve #7) facial nerve palsy;pt given pred to taper every day by 10mg;pt was advised to stay home & drink plenty of fluids until feels better;sx are slowly fading;				Y					N	10/19/1997	10/21/1997	2	NONE	MIL	MIL	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Eye disorder; Facial palsy	FLU3~CONNAUGHT LABORATORIES~4978177~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0104471	11/06/1997	OR	20.0	20		F	10/27/1997	by the next morning, pt had hives across stomach;went to clinic serving community;				Y					Y	10/22/1997	10/23/1997	1		OTH	OTH				~ ()~~~In patient		1						1	Urticaria	FLU3~PFIZER\WYETH~4978142~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104472	11/06/1997	NY	47.0	47		F	10/30/1997	red raised area rt deltoid;inc temp;										10/28/1997	10/29/1997	1		PVT	PVT	Vasotec;Amox	sinusitis		~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81895~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~442521~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0104477	11/06/1997	TX	51.0	51		F	10/31/1997	pt recv vax & woke up Saturday w/ red throat, sneezing, coughing, runny eyes, nose;by Sunday went into chest;had to use machine many months;was sick about 1wk;									Y	10/17/1997	10/18/1997	1		OTH	PVT		was feeling great	asthma, allergics (hayfever)	pt devel nausea @ 50yr old w/flu/pneumonia;~ ()~~~In patient		1						1	Asthma; Condition aggravated; Cough; Lacrimal disorder; Lung disorder; Malaise; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104480	11/06/1997	WI	65.0	65		F	10/29/1997	itching, hives, glands under chin, arms & in abd area swelled & became hard, both eyes swelled shut;sx lt p/1wk;DPH taken every 4hr for 5 days;									Y	10/15/1997	10/15/1997	0		PVT	UNK		NONE	anti-biotics-some food allergic	pt exp rxn w/flu vax dose 1 @ age 41;& rxn w/yellow fever dose 1 @ 26yr old;~ ()~~~In patient		1						1	Face oedema; Lymphadenopathy; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81817~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104253	11/07/1997	MD	71.0	71		M	11/04/1997	presented on 4NOV 930AM;immed care w/SOB, weakness, cyanotic, pallor, swelling lt arm distal forearm to hand-denied trauma to arm & stated it had been swollen since inj-T96.8 A	Y	11/04/1997							N	10/28/1997	10/28/1997	0	refused lab work	PUB	PUB	NONE	NONE	hx ETOH, tobacco use;	~ ()~~~In patient	MD97013	1						2	Asthenia; Cyanosis; Dyspnoea; Hypothermia; Oedema peripheral; Pallor; Asthenia; Cyanosis; Dyspnoea; Hypothermia; Oedema peripheral; Pallor; Apnoea; Asthenia; Cyanosis; Dyspnoea; Hypokinesia; Hypoxia; Malaise; Oedema peripheral; Asthenia; Cyanosis; Dyspnoea; Hypoxia; Oedema peripheral; Pallor	FLU3~MEDEVA PHARMA, LTD.~E20017HC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~441214~1~IM~RA~PNEUMO (PNU-IMUNE)~1|FLU3~MEDEVA PHARMA, LTD.~E20017HC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~PFIZER\WYETH~441247~1~IM~RA~PNEUMO (PNU-IMUNE)~2|FLU3~MEDEVA PHARMA, LTD.~E20017HC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~3|PPV~PFIZER\WYETH~441249998~UNK~IM~~PNEUMO (PNU-IMUNE)~3|FLU3~MEDEVA PHARMA, LTD.~E20017HC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~4|PPV~PFIZER\WYETH~441247~1~IM~RA~PNEUMO (PNU-IMUNE)~4	USA	Results in Death	Influenza
0104380	11/07/1997	MI	75.0	74		M	10/14/1997	pt recv vax 10OCT97 & 11OCT97 & pt devel chills, h/a which described as feeling like a sinus h/a;sx cont through Sunday & Monday AM felt heart out of rhythm, having fibrillation, pulse irregular;BP monitor inaccurate;red & sore arm;					Y	3			Y	10/10/1997	10/11/1997	1	blood cult x 3;12,000 WBX, segs 85, band nl;	PUB	PUB	Xanax;ASA;Lanoxin;Calan;Quihagbute	hx cardiovascular disease;no acute illness	chronic atrial fib per MD hx cardiosvascular disease;	NONE~ ()~~~In patient	MI97123	1						1	Arrhythmia; Chills; Condition aggravated; Headache; Injection site hypersensitivity; Injection site pain; Sinusitis; Ventricular fibrillation	FLU3~PFIZER\WYETH~4978200~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0994E~1~SC~RA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~7C91556~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0104493	11/07/1997	MA	31.0	31		M		fever 100-101 x 3 days;body aches;nasal congestion;sore throat, lost taste;				Y					N	10/28/1997	10/29/1997	1	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MA9724	1						1	Ageusia; Myalgia; Pharyngitis; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~7F81793~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0104495	11/07/1997	TN				F	11/06/1997	pt recv vax & began to hurt w/throbbing into muscle & down to elbow w/redness occurring from inj site to elbow;told to apply warm compress & notify MD if persists;									U	10/16/1997	10/16/1997	0		OTH	OTH				~ ()~~~In patient		1						1	Injection site hypersensitivity; Myalgia; Pain	FLU3~MEDEVA PHARMA, LTD.~E20037KA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104496	11/07/1997	TN				F	11/06/1997	pt recv vax & no apparent problems then excruciating pain in one of arms;dx w/muscle spasms not r/t inj;				Y					Y	10/20/1997	10/20/1997	0		OTH	OTH				~ ()~~~In patient		1						1	Hypertonia; Pain	FLU3~MEDEVA PHARMA, LTD.~3367HB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0995E~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0104497	11/07/1997	TN				M	11/06/1997	inj site red hot & swollen approx 3 inches diameter afeb;no aches or chills-instructed to cont to monitor if sx cont contact MD;									U	10/27/1997	10/28/1997	1		OTH	OTH				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104500	11/07/1997	MA	82.0	82		F	10/31/1997	c/o pain radiating down lt side of chest wall 1 day p/vax, nausea, dizziness, SOB;?anginal or rxn to flu shot;pain subsided in 1-2 days;				Y					Y	10/14/1997	10/15/1997	1	EKE done, lab work	PUB	PUB	Insulin bid, vasotec, calan, NTG PRN, ASA, Ducolas, Maalox	NONE	diabetes, hx of angina, inc BP	~ ()~~~In patient	MA9715	1						1	Angina pectoris; Chest pain; Condition aggravated; Dizziness; Dyspnoea; Nausea	FLU3~CONNAUGHT LABORATORIES~7F81793~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0104501	11/07/1997	MA	49.0	49		F	11/03/1997	awoke on 21OCT97 noticed a rash all over body had c/o flu like sx on 20OCT97 evening recovered in 1 day;				Y					Y	10/20/1997	10/20/1997	0	NONE	PUB	PUB		NONE	migraine hx	pt exp rash w/flu vax 20 yr ago~ ()~~~In patient	MA9717	1						1	Influenza; Rash	FLU3~CONNAUGHT LABORATORIES~7F81793~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0104503	11/07/1997	MA	48.0	48		U	11/03/1997	projectile vomiting, aches all over, chills, head cold, cough, fever									Y	10/29/1997	10/31/1997	2	NONE	PUB	PUB		NONE	seasonal allergies	~ ()~~~In patient	MA9713	1						1	Chills; Cough; Myalgia; Pyrexia; Rhinitis; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81793~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104504	11/07/1997	MA	65.0			F	11/03/1997	pounding  h/a, queasy, stomach;									Y	10/18/1997	10/19/1997	1	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MA9712	1						1	Dyspepsia; Headache	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104505	11/07/1997	MA	74.0			M	10/31/1997	24hr p/vax h/a, cough, gen aches, fever, +sputum prod, sore throat;									Y	10/18/1997	10/19/1997	1	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MA9711	1						1	Cough; Headache; Myalgia; Pharyngitis; Productive cough; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81793~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104506	11/07/1997	MA	53.0	53		F	10/30/1997	pt recv vax  & later noticed aching all over, fever, nausea, 14hr p/vax vomiting x 2, flu like sx;									Y	10/29/1997	10/29/1997	0		PUB	PUB	Lavoxil;Premarin	NONE	dust/pollen allergies;	~ ()~~~In patient	MA9714	1						1	Influenza; Myalgia; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81793~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104507	11/07/1997	MA	39.0	39		F	10/27/1997	p/vax pt felt faint;then pt briefly passed out then pt vomited;MD felt pt episode sz secondary to vasovagal response;									Y	10/18/1997	10/18/1997	0		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MA9718	1						1	Condition aggravated; Convulsion; Syncope; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81793~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0995E~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0104510	11/07/1997	MI	71.0	71		M	10/07/1997	pt recv vax 3OCT97 & c/o soreness on 4OCt97;apparent bruising @ inj site w/noticeable white area around inj site on 5OCT97;refer to pvt MD:				Y					U	10/03/1997	10/05/1997	2		PUB	PUB	sinemet;ticlid;vasotec	NONE	bi-pass & corotid artery surgery 1995;	~ ()~~~In patient	MI97113	1						1	Ecchymosis; Injection site reaction; Myalgia	FLU3~PFIZER\WYETH~4978196~6~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~7C91556~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0104511	11/07/1997	MI	69.0	69		F	10/09/1997	pt states p/vax 6OCT97 that evening arm became red, sl swollen & warm to touch, just under inj site on lt arm;pt was seen @ hosp 9OCt97; dx local rxn to Td vax;tx w/cold compresses to lt upper arm, prescription for keflex;				Y					Y	10/06/1997	10/06/1997	0	NONE	PUB	UNK		NONE	NONE	NONE~ ()~~~In patient	MI97115	1						1	Injection site hypersensitivity; Injection site oedema; Injection site reaction; Vasodilatation	FLU3~PFIZER\WYETH~4978196~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~7C91556~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0104516	11/07/1997	MI	65.0			F	10/17/1997	9OCT97 pt recv vax 10OCT97 small nodule & itched & soreness devel cont to inc in size & severity of pruritus;used warm compresses;redness extends from 3 inches below shoulder to 3 inches above elbow;warm to touch;				Y						10/09/1997	10/10/1997	1		PUB	UNK	Tenormin;ASA daily;Estrogen	NONE	PCN allergy	~ ()~~~In patient	MI97124	1						1	Injection site mass; Injection site oedema; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~4978196~7+~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~7C91556~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0104517	11/07/1997	MI	78.0	78		M	10/17/1997	presents w/ 3 inches of erythema, swelling & warmth to rt deltoid region;states has been getting worse;no treatment;disrupting sleep;									U	10/15/1997	10/15/1997	0	NONE	PUB	UNK	ASA, vasotec, Lopressor, Hytrin, hydrochlorothiazide, Zantac	NONE	high blood pressure, MI, by pass surgery;	NONE~ ()~~~In patient	MI97125	1						1	Injection site hypersensitivity; Injection site oedema; Insomnia; Vasodilatation	FLU3~PFIZER\WYETH~4978196~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~431805~2~SC~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0104522	11/07/1997	IL	31.0	31		M	10/29/1997	pt recv vax 22OCt97 3PM & 4PM had h/a, didn't feel good was very hot but did not take temp;had loss of appetite;body itched that evening next morning;noticed rash on stomach;next day rash on sides of neck;legs marbled looking but no rash										10/22/1997	10/22/1997	0	NONE	PUB	PUB	NONE	NONE	allergic to PCN	NONE~ ()~~~In patient	IL97097	1						1	Anorexia; Headache; Malaise; Pruritus; Rash; Skin discolouration; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104524	11/07/1997	MO	54.0	54		F	10/24/1997	pt recv vax & 8PM eyes watering, nasal discharge, oral cavity hot w/swelling of gums-gums excessively red in color;mouth uncomfortable & gums swollen x8hr-no dyspnea, no hives, NKA;									Y	10/20/1997	10/20/1997	0		PUB	PUB		NONE	NONE	~ ()~~~In patient	MO97048	1						1	Gingival hyperplasia; Lacrimal disorder; Mucous membrane disorder; Rhinitis	FLU3~CONNAUGHT LABORATORIES~7F81816~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104525	11/07/1997	MO	62.0	62		F	10/22/1997	swelling to throat, lips, & tongue w/moderate dyspnea lasting approx 24hr p/vax;did not seek treatment;									Y	10/09/1997	10/09/1997	0	NA	PUB	PUB	Estrogen;Accupril	NONE	NONE	~ ()~~~In patient	MO97047	1						1	Dyspnoea; Face oedema; Laryngospasm; Tongue oedema	FLU3~CONNAUGHT LABORATORIES~7F81884~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104526	11/07/1997	MO	35.0	35		F	10/28/1997	4-5 days post vax devel rt upper arm muscle soreness which has persisted for about 2 1/2 wk;no localized redness, no fever, chills, numbness or tingling;had nl achiness fro the shot pain;no bruising;				Y					U	10/08/1997	10/12/1997	4	NONE	OTH	UNK	Tricyclen;Excedrin	NONE	NONE	NONE~ ()~~~In patient	MO97046	1						1	Myalgia	FLU3~PFIZER\WYETH~4978194~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104527	11/07/1997	MO	52.0	52		F	10/25/1997	sever nausea, h/a, chills, fever, hives on stomach-back;tx took calritin-ASA;									Y	10/22/1997	10/23/1997	1	NONE	PUB	PUB		NONE	NONE	~ ()~~~In patient	MO97045	1						1	Chills; Headache; Nausea; Pyrexia; Urticaria	FLU3~PFIZER\WYETH~7F81816~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104528	11/07/1997	MO	41.0	41		F	10/17/1997	swelling of upper legs 45min p/vax;regression w/in 24hr p/treatment w/solumedrol & DPH;									Y	10/16/1997	10/16/1997	0	NA	PVT	UNK	na	NA	NA	NA~ ()~~~In patient		1						1	Face oedema	FLU3~PFIZER\WYETH~7F81740~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104529	11/07/1997	AL	5.0	5		F	10/29/1997	devel urticaria rash on face & edematous eyelids;tx w/epi & DPH;225PM rash on face resolving;left clinic 310PM DPH given;									Y	10/27/1997	10/27/1997	0	NA	OTH	OTH	NONE	NONE	NONE	NA~ ()~~~In patient	AL9731	1						1	Face oedema; Urticaria	FLU3~PFIZER\WYETH~7F81754~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~436764~3~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0104530	11/07/1997	TX	26.0	26		F	10/31/1997	onset of itching & throat constriction <30min p/shot;				Y					Y	10/30/1997	10/30/1997	0	NA	OTH	PVT	lithium;levoxil	NA	PCN & macrolide;allergy, van willibrands;congential rubella;	NA~ ()~~~In patient		1						1	Laryngospasm; Pruritus	FLU3~MEDEVA PHARMA, LTD.~E20017HC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0104532	11/07/1997	CA	59.0	59		F	11/01/1997	2nd day severe joint pains, 3rd day n/v;4th day felt better but still had joint pain;still have sciatic pain lt side;									Y	10/13/1997	10/14/1997	1	NOEN	PUB	PVT	NONE	NONE	ulcers-cystitis	NONE~ ()~~~In patient		1						1	Arthralgia; Back pain; Vomiting	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104537	11/07/1997	MT	61.0	61		F	10/31/1997	devel redness, pain & swelling @ inj site 2 days p/vax;									Y	10/16/1997	10/18/1997	2	NOEN	PVT	PVT	rheumatrex;fiourinae	rheujmatoid arthritis;	migraine h/a, rheumatoid arthritis	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81840~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104540	11/07/1997	MO	51.0	51		F	11/03/1997	severe myalgias, arthralgias, worsening of HTN, now over 2wk p/flu vax;									N	10/17/1997	10/17/1997	0		PVT	PVT	NONE	NONE	NONE x/borderline HBP			1						1	Arthralgia; Hypertension; Myalgia	FLU3~MEDEVA PHARMA, LTD.~E3277GA~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~SMITHKLINE BEECHAM~535A6~1~IM~LA~HEP A (HAVRIX)~1	USA		Influenza
0104541	11/07/1997	CA	57.0	57		F	11/03/1997	body aches, chills, awakened @ 0300;fine by 0800 28OCT97;felt fine;then 29OCT97 had hand surgery;30OCt97 had T101.0, achy, chills x 24hr;									Y	10/27/1997	10/28/1997	1	NOE	PUB	PVT	ASA;CArdiazem;Tanoxifen;Nitrodur patch;Nardil	NONE	NKA;hand surgery 29OCT97;	NONE~ ()~~~In patient		1						1	Chills; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4978189~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104542	11/07/1997	CA	64.0	64		M	11/01/1997	onslaught of flu sx fever, sore throat, cough, aching joints;last 1wk;no professional tx;									Y	10/15/1997	10/17/1997	2	NONE	PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Arthralgia; Cough; Influenza; Pharyngitis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104543	11/07/1997	CA	51.0	51		F	11/01/1997	p/30 hr pt got the flu started w/ scratchy throat, then aches, fever, sore throat, sinus infect, laryngitis;									Y	10/08/1997	10/09/1997	1		OTH	OTH	NONE	NONE	NONE	pt devel severe flu  & T106 w/flu vax;~ ()~~~In patient		1						1	Influenza; Laryngitis; Myalgia; Pharyngitis; Pyrexia; Sinusitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104545	11/07/1997	PA	72.0	72		F	11/03/1997	swollen hyperemia area lt outer area;rx clariten, durcef;				Y					Y	10/27/1997			NONE	PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~MEDEVA PHARMA, LTD.~E3277GB~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0104881	11/07/1997	MI	65.0	65		F	10/06/1997	pt describes pain @ the site 12hr p/vax;states was swollen from shoulder to elbow, hot & hard to touch;affected lt extremity;pt states applied ben gay to arm to aid in sleep;arm remained painful-36hr now resolved;									Y	10/03/1997	10/03/1997	0	NONE	PUB	PUB		NONE	IDDM, HTN (hypertension)	NONE~ ()~~~In patient	MI97114	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Oedema peripheral; Pain; Skin nodule; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E32976B~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0994E~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0105000	11/07/1997	OR	38.0			F	07/24/1997	pt recv vax NOV96 & exp a facial eruption;the eruption was dx as herpes simples 1;pt states that cont to exp monthly eruptions & that during times of the eruptions, pt is unable to work or have contact w/children;				Y					N	11/01/1996				PVT	OTH	NONE	NONE		~ ()~~~In patient	897223008L	1						1	Dermatitis bullous; Infection	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105001	11/07/1997	CO	48.0	48		F	07/15/1997	1 weekafter receiving an injection of FLU SHIELD(1996-97 Formula), the patient developed lymphadenopathy, joint pain and pain in her right arm. The lymphadenopathy resolved, but the pain persisted as of 7/15/97. An extensive work-up to determine the cause of the pain has been negative. The patinet was taking hydrocodone with acetaminiphen 10MG/650MG three times daily and as needed for pain relief.				Y					U	11/24/1996	11/26/1996	2	MRI: biceps tendon impingement	PVT	PVT	RITALIN	NONE			897223012L	1						1	Arthralgia; Lymphadenopathy; Pain	FLU3~PFIZER\WYETH~4968209~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105002	11/07/1997	NJ	54.0	54		F	08/18/1997	pt heard a gurgling in lungs;CXR showed a spot;31OCT96 pt recv vax;a few wk later pt stated felt like a flu-like achiness all over body;consulted another MD who referred to neuro;neuro dx condition as chronic inflam demyelinating neuropathy				Y					U	10/31/1996				OTH	OTH	NONE	unk		~ ()~~~In patient	897233011L	1						1	Influenza; Lung disorder; Myalgia; Neuropathy	FLU3~PFIZER\WYETH~4968139~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105003	11/07/1997	NY	4.0			F	08/22/1997	pt recv vax & had an unspecified adverse exp;no further info was available @ the date of this report;									Y					OTH	OTH	unk	unk		~ ()~~~In patient	897239013L	1						1	Unevaluable event	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105004	11/07/1997	KY				F	09/26/1997	1 day p/vax pt devel an inj site rxn characterized by redness & warmth;this is 1 of 2 pt from this  site to devel an inj site rxn p/vax w/lot# 4978148									U	09/25/1997	09/26/1997	1		PVT	OTH	UNK	UNK		~ ()~~~In patient	897273044L	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PFIZER\WYETH~4978148~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105005	11/07/1997	KY				U	09/26/1997	pt recv vax & devel redness & itching @ inj site suggestive of an allergic rxn;									U					PVT	OTH	unk	unk		~ ()~~~In patient	897273046L	1						1	Hypersensitivity; Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~4978148~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105006	11/07/1997	CA	65.0			F	09/30/1997	w/in 3 days p/vax pt was unable to walk & could not feel hands;									U	09/24/1997				OTH	OTH	unk	unk		~ ()~~~In patient	897275021L	1						1	Gait disturbance; Paraesthesia	FLU3~PFIZER\WYETH~4978149~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105007	11/07/1997	CA				F	09/30/1997	pt devel flu-like sx w/in 3 days of vax;									U	09/25/1997				OTH	OTH	unk	unk		~ ()~~~In patient	897275022L	1						1	Influenza	FLU3~PFIZER\WYETH~4978149~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105008	11/07/1997	CA				F	09/30/1997	pt recv vax & devel flu-like sx w/in 3 days of vax;									U	09/25/1997				OTH	OTH	unk	unk		~ ()~~~In patient	897275023L	1						1	Influenza	FLU3~PFIZER\WYETH~4978149~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105009	11/07/1997	TX	63.0	63		M	09/30/1997	pt recv vax & exp blurred vision & aching of both eyes;30SEP97 (7 days post vax)  vision in lt eye had returned to baseline but vision in rt eye was cont to deteriorate;corrected vision in rt eye was 20/50 & 30SEP;dx optic neuritis;				Y					N	09/23/1997	09/25/1997	2	30SEP97 MRI of the head-no abnormalities;	OTH	OTH	Xanax;Sectral; Pepcid, Lanoxin	unk	head & hand tremor for approx 1yr;pt may have mult sclerosis-work-up not complete;	~ ()~~~In patient	897279011L	1						1	Amblyopia; Eye disorder; Eye pain; Optic neuritis; Visual disturbance; Visual field defect	FLU3~PFIZER\WYETH~4978143~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0103867	11/10/1997	MA	54.0	54		M	11/07/1997	pt recv vax 15OCT97 & 2 days later 17OCT97 pt exp chest pains during breathing & dull pain between the shoulder blades;pt was seen in ER & adm to the hosp for a duration of 2 days;dx was pericarditis;				Y	Y	2			Y	10/15/1997	10/17/1997	2		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	CO7705	1						2	Back pain; Chest pain; Back pain; Chest pain; Pericarditis	FLU3~CONNAUGHT LABORATORIES~7F81793~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7F81793~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0104482	11/10/1997	FL	37.0	37		M	11/03/1997	tingling in fingers, toes, gen weakness & paralysis presently hosp;dx GBS;tx plasmapheresis					Y				U	10/23/1997	10/29/1997	6		MIL	MIL	Zantc		Gastroesophageal reflux	~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome; Paraesthesia; Paralysis	FLU3~PFIZER\WYETH~4978199~7+~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0104488	11/10/1997	GA	77.0	77		F	10/09/1997	states recv immun 1130AM & felt fine until about 7PM when started having lt side abd pain cont through noc & still w/ complaints this AM;states no inc temp or any other sx;referred to MD;23OCT97 MD felt episode d/t Coumadin not vax-pt OK no					Y	5				10/08/1997	10/08/1997	0		PUB	PUB	Coumadin-4 other meds		states on 5 different med for various problems;	~ ()~~~In patient	GA97129	1						1	Abdominal pain	FLU3~CONNAUGHT LABORATORIES~7F81832~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0104490	11/10/1997	GA	55.0	55		F	09/10/1997	pt states on 8NOV96 pt had severe h/a-could not focus eyes-did not see MD on 18NOV97 onset of numbness lt leg, lt hand, lt side of face;saw MD was referred to MD & adm to hosp x 3 days;told had diabetic stroke;devel pain dx neuropathy;				Y	Y	3		Y	N	11/01/1996	11/08/1996	7	NA	PVT	PUB	Novolin;Insulin;Cozar	NONE	diabetes	~ ()~~~In patient	GA97124	1						1	Antinuclear antibody; Cerebrovascular accident; Condition aggravated; Headache; Neuropathy; Pain; Paraesthesia; Visual disturbance	FLU3~MEDEVA PHARMA, LTD.~E3036GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0104554	11/10/1997	NJ	47.0			F		acute allergic vasospasm w/bronchospasm;					Y								EKG sinus tachycardia;	UNK	UNK				pt exp allergic rxn to ? flu cax 15yr ago;~ ()~~~In patient		1						1	Asthma; Hypersensitivity; Tachycardia; Vasospasm	FLUX~UNKNOWN MANUFACTURER~7F81830~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0104556	11/10/1997	MI	41.0	41		F	11/03/1997	30OCT that noc inj site was very sore w/large bump;31OCT bad h/a inj site very sore;1NOV lethargic, severe h/a, T103, muscle aches;2NOV T103, diarrhea, muscles aches;3NOV recovering still some diarrhea;treated self w/APAP & ASA									Y	10/30/1997	10/30/1997	0	NONE	PUB	PUB	NONE	NONE	unk	~ ()~~~In patient	MI97136	1						1	Diarrhoea; Headache; Injection site mass; Injection site pain; Myalgia; Pyrexia; Somnolence	FLU3~PFIZER\WYETH~4978168~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104557	11/10/1997	NY	56.0	56		F	10/31/1997	pt recv vax & 25OCT early AM lt arm throbbing-took advil;malaise & body aches which improved by SUnday;26OCT97 fine rash upper body noted in evening;lt arm had become tender, red, swollen including axilla & hot;				Y					Y	10/24/1997	10/25/1997	1		PUB	PUB	Premarin;Thyroid;	NONE	thyroid def	~ ()~~~In patient	NYS97058	1						1	Lymphadenopathy; Malaise; Myalgia; Oedema peripheral; Pain; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4978169~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~445636~1~SC~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0104560	11/10/1997	FL	81.0	81		M	11/04/1997	pt recv vax & devel sweating, gen weakness;pt was wobbly;26OCT unsteady taken to ER MD dx as rxn to flu vax;pt hosp w/CVA & released 22OCT97;				Y					U	10/24/1997	10/25/1997	1	blood work;lungs xray;EKG;	PUB	PUB	Coumadin;Uraponsil hemolin	recurrent CVA	rehab p/CVA	unk~ ()~~~In patient	FL97081	1						1	Asthenia; Coordination abnormal; Dizziness; Hyperhidrosis	FLU3~MEDEVA PHARMA, LTD.~E3287GA~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0104561	11/10/1997	MA	73.0	73		F	11/03/1997	red patch on lower back sized 3 x 5 - hot & itchy & raised (waffled);saw NP who prescribed med;a second small area devel later & is still evident;				Y					Y	10/08/1997	10/09/1997	1		PUB	PUB	Metrogel & Nizaoral;QOD;	NONE	rosacea;allergy to sulfa drugs, phenothelane & eprinephrine;	NONE~ ()~~~In patient	MA9723	1						1	Pruritus; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~7F81793~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0104562	11/10/1997	NM	57.0	57		F	10/27/1997	urticaria over total body;mild resp distress-no wheezing;tight feeling throat;				Y					Y	10/27/1997	10/27/1997	0	NA	PUB	UNK		NONE	IVP dye;RAD	~ ()~~~In patient	NM97026	1						1	Dyspnoea; Laryngospasm; Urticaria	FLU3~PFIZER\WYETH~4978165~3~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104566	11/10/1997	OH	79.0	79		F	10/21/1997	morning p/vax given inj site appeared hard, red, swollen, sore;redness & swelling extended down arm to forearm, to breast & underarm;seen by MD told may have infect given ATB;also had fever & chills 24hr p/vax;				Y						10/16/1997	10/17/1997	1		PUB	PUB		NONE	NONE	~ ()~~~In patient	OH97077	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Lymphadenopathy; Oedema peripheral; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4978200~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~436820~1~SC~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0104567	11/10/1997	OH	20.0	20		F	10/27/1997	about 20min p/vax pt was @ work & started feeling weird body weakness & body warmth;pt noticed rash about arms stomach, back & legs;had severe itching;supervisor took pt to ER where given epi & DPH;				Y					Y	10/22/1997	10/22/1997	0	NONE	PUB	PUB				~ ()~~~In patient	OH97078	1						1	Malaise; Myasthenic syndrome; Pruritus; Rash; Vasodilatation	FLU3~PFIZER\WYETH~7F81917~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104570	11/10/1997	IN	29.0	29		F	11/05/1997	pt states inj site became red & painful & swollen;devel itching over upper half of body;also reports h/a;one hive present lt arm near inj site;				Y					Y	11/05/1997	11/05/1997	0		PVT	PVT				~ ()~~~In patient		1						1	Headache; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81865~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0104571	11/10/1997	NY	42.0	41		F	10/29/1997	describes lightheadedness, sweating, feeling shaky;pt states felt like when had CT scan dye (1984);				Y					Y	10/29/1997	10/29/1997	0		UNK	OTH	synthroid	denies	denies x/hives p/CT scan dye	~ ()~~~In patient		1						1	Dizziness; Hyperhidrosis; Hypersensitivity	FLU3~CONNAUGHT LABORATORIES~7F81857~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0104580	11/10/1997	SC	55.0	55		F	10/20/1997	48hr p/inj arm sore & red w/diameter 1 lasted for 2 days;									Y	10/14/1997	10/16/1997	2		UNK	UNK	Les Col	NONE	allergy to codeine	~ ()~~~In patient	SC97059	1						1	Injection site hypersensitivity; Injection site pain	FLU3~MEDEVA PHARMA, LTD.~E32872GA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104581	11/10/1997	SC	30.0	30		F	10/20/1997	severe soreness in arm 13OCt & 14OCT;fever in arm 14OCT;cont pain, throbbing, unable to lift arm out or over head 16-17OCT;APAP for pain, cool compacts during onset of fever (3X day)work arm throughout day, if pain consist through weekend;									Y	10/13/1997	10/13/1997	0		PUB	PUB	NA	NONE		~ ()~~~In patient	SC97057	1						1	Hypokinesia; Pain; Pyrexia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3287GH~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104582	11/10/1997	SC	41.0	41		F	10/20/1997	pt came into clinic AM of 15OCt w/hot, red swollen area;Rn told pt to take APAP apply cool compress (3X) daily;pt returned 16OCT area was still red, no fever but area was hard;17OCT97 area still a little hard;									Y	10/14/1997	10/15/1997	1		PUB	PUB	PPD by Connuaught lot#245311 given 14OCT97		NA	~ ()~~~In patient	SC97056	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3287GA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~CONNAUGHT LABORATORIES~6K81354~1~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0104583	11/10/1997	SC	40.0	40		F	10/22/1997	14OCT97 pt recv vax;17OCT97 unable to move, very painful, sl fever used heating pad, APAP 22OCT97 unable to reach out still applying heat some fever found by RN;told to use cool compress APAP;										10/14/1997	10/17/1997	3		UNK	UNK	s			~ ()~~~In patient	SC97055	1						1	Hypokinesia; Pain; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E32872GA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104584	11/10/1997	MO	64.0	64		F		erythema 3 x 3 & large lump devel-noticed first on 22OCT97;soreness @ site began 22OCT97;									Y	10/16/1997	10/29/1997	13		PUB	UNK	Napropin;Isosorbide	NONE	codeine-arthritis rt knee;angina	~ ()~~~In patient	MO97049	1						1	Injection site pain; Rash; Skin nodule	FLU3~CONNAUGHT LABORATORIES~7F81896~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~7C91574~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0104587	11/10/1997	MI	56.0	56		F	10/30/1997	severe chills, fever, h/a, swelling, size of golf ball armpit of inj arm, local soreness shoulder to elbow rt arm, duration 3-4 days;									Y	10/03/1997	10/03/1997	0		OTH	PVT	Fosamax;Ibuprophine	NONE	post polio synd	~ ()~~~In patient		1						1	Chills; Headache; Injection site pain; Lymphadenopathy; Pain; Pyrexia; Skin nodule	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0104588	11/10/1997	PA	33.0	33		F		red, swollen, warm area on LA;pt was put on E-Mycin;									U	10/30/1997	10/31/1997	1	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E32776B~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104589	11/10/1997	OH	59.0	59		F		pt recv vax 16OCT97 & 2AM 17OCT97 began w/diarrhea & vomiting;severe diarrhea lasted until 7AM;for the next 6 days did not feel good;sl h/a excessively tired, listless, ached, stomachache;then all sx abated;itching around inj site;									Y	10/16/1997	10/17/1997	1	NA	OTH	OTH	Premarin;Oyst-cal	end of migraine exp 24hr a/caused by sensitivity to methyl parabene in shampoo		~ ()~~~In patient		1						1	Asthenia; Diarrhoea; Headache; Injection site hypersensitivity; Malaise; Myalgia; Pruritus; Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104590	11/10/1997	GA	49.0	48		F	10/28/1997	flu like;swollen lymph glands in throat eyes became very red, pus formed for 24hr;chills, fever, sore muscles in legs;									Y	10/27/1997	10/27/1997	0		PVT	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						1	Conjunctivitis; Infection; Influenza; Lymphadenopathy; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104593	11/10/1997	GA	73.0	73		F	10/09/1997	redness, heat, swelling, rash about 6-8cm;diameter around inj site;sleepier than usual;local rxn to vax but lethargy;discomfort @ site;									Y	09/30/1997	09/30/1997	0		PUB	PUB		denies		~ ()~~~In patient	GA97128	1						1	Injection site hypersensitivity; Injection site oedema; Somnolence; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104597	11/10/1997	MS	49.0	48		F	11/04/1997	rt arm became sore same day of inj then painful next day;On 3rd day had red splotchy erythematous areas around & below inj site;saw MD 30OCT97 & dx rxn to pneumovax;									Y	10/28/1997	10/28/1997	0	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MS97043	1						1	Injection site hypersensitivity; Pain; Rash maculo-papular	FLU3~MEDEVA PHARMA, LTD.~E20017HC~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0585D~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0104598	11/10/1997	MS	75.0	75		F	10/29/1997	redness, swelling upper rt arm;tender & hot to touch (onset approx 5PM 28OCT97 w/ 2 row long blisters-went away);c/o redness, swelling & pain rt arm;									Y	10/28/1997	10/28/1997	0		PUB	UNK	Synthroid, Congard, Formax	NONE	hypert, thyroid prob	NONE~ ()~~~In patient	MS97044	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3327GA~7+~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~~2~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0104551	11/11/1997	VA	38.0	38		F	11/03/1997	pt recv vax 12noon 9OCT97 exp feeling shaky, perspiring, throat closing @ 2PM;relieved somewhat w/DPH;sx recurred @ 4PM to ER & treated for anaphylactic rxn;			Y	Y					Y	10/09/1997	10/09/1997	0	NONE	PUB	PUB	NONE	NONE	has recv flu vax in pre yr w/no problem;	NONE~ ()~~~In patient	VA97053	1						1	Anaphylactoid reaction; Hyperhidrosis; Laryngospasm; Tremor	FLU3~PFIZER\WYETH~4978169~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening	Influenza
0104553	11/11/1997	MI	44.0			F	07/01/1997	pt exp mild swelling & discomfort @ inj site later that same day sx gradually inc over the next 3 days & by 4th day could not move arm w/o  pain;throbbing sensation & edema & erythema of lt shoulder;firm mass;cult grew A radiobacter;				Y	Y	2			Y				PE-mild edema & erythema of the lt shoulder on admission;VS stable;temp nl;WBC 11,000;chem panel nl; CPK 52;ESR 15;	OTH	PVT	NONE	NONE	NONE REPORTED	~ ()~~~In patient	10150970129000	1						1	Hypokinesia; Infection; Injection site oedema; Injection site pain; Oedema peripheral; Pain; Rash; Skin nodule	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0104600	11/11/1997	MI	72.0	72		F	11/10/1997	sore throat, head cold, light fever, cough, tickle in throat, about strangle, tired & felt bad, hard to breath, hard to breath deep, chills one noc, lt arm sore;									Y	10/22/1997	10/24/1997	2		PUB	PUB	BP meds	NONE		~ ()~~~In patient	MI98061	1						1	Asthenia; Chills; Cough; Dyspnoea; Malaise; Pharyngitis; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104601	11/11/1997	MN	25.0	25		F	10/31/1997	pt reported lightheadedness, dizziness, queasiness, periodic rushes in heartbeat, legs feeling wobbly soon p/vax;referred to MD of choice;MD recommended to go home & rest;MD felt pt was exp a rxn to the vax;exp T99 & one episode of vomiting				Y					Y	10/29/1997	10/29/1997	0	NONE	PUB	PUB		NONE	NONE	~ ()~~~In patient	MN97045	1						1	Dizziness; Myasthenic syndrome; Nausea; Pyrexia; Tachycardia; Vomiting	FLU3~PFIZER\WYETH~4978212~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104602	11/11/1997	TX	51.0	51		F	10/30/1997	approx 1/2hr p/vax pt exp numbness to tongue;pt given DPH;tingling in legs/feet, arms/hands;				Y					Y	10/22/1997	10/22/1997	0		PUB	PUB		NONE	NONE	NONE~ ()~~~In patient	TX97146	1						1	Paraesthesia; Tongue disorder	FLU3~MEDEVA PHARMA, LTD.~E3297GB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~CONNAUGHT LABORATORIES~7E91657~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0104603	11/11/1997	OH	70.0			M	10/31/1997	w/in 48hr had weakness in  measles of both arms;saw MD APR97 & referred to a neuro APR97 told pt it was from a virus in the flu shot;									Y	10/28/1996	10/30/1996	2	NONE	PUB	PUB		NONE	NONE	~ ()~~~In patient	OH97081	1						1	Infection; Myasthenic syndrome	FLU3~PARKE-DAVIS~00276P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0104425	11/12/1997	CA	74.0	74		F	10/30/1997	vomiting, diarrhea, throat & roof of mouth red, fever 100, rash in groin area & up lower abd both sides, chapped lips that peeled;lost 6 pounds;contacted MD 20OCT said take DPH antihistamine it helped 30OCT97 still feel a little weak;									Y	10/16/1997	10/17/1997	1		PUB	UNK	NONE	NONE	physical 3OCT97 report in good health	~ ()~~~In patient		1						2	Asthenia; Dermatitis exfoliative; Diarrhoea; Pharyngitis; Pyrexia; Rash; Vomiting; Weight decreased; Asthenia; Dermatitis exfoliative; Diarrhoea; Pharyngitis; Pyrexia; Rash; Vomiting; Weight decreased	FLU3~CONNAUGHT LABORATORIES~7F81841~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7F81841~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0104608	11/12/1997	MD	10.0	10		M	11/04/1997	body cramps, chills, fever inc 105, h/a, throat hurt, perspiring, body aches;			Y	Y					Y	10/29/1997	10/29/1997	0	2 strep tests, WBC, platelet count all WNL;	PVT	PVT	Beclovent inhaler;Imipramine;	NONE	mild asthma;	~ ()~~~In patient		1						1	Chills; Headache; Hyperhidrosis; Myalgia; Pain; Pharyngitis; Pyrexia	FLU3~PFIZER\WYETH~4978139~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening	Influenza
0104611	11/12/1997	OH				M	10/24/1997	pt recv vax & exp injuries which will be w/pt throughout the rest of life;								Y	N					OTH	OTH	unk	unk		~ ()~~~In patient	897302014L	1						1	Unevaluable event	FLUX~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0104618	11/12/1997	PA	80.0	80		M	11/05/1997	pt devel severe purplish, vasculitic & petechial rash 8 days p/vax; pt hosp last year;rash reappeared this year again 8 days p/flu vax;no hosp required this year;				Y	Y	6			Y	10/23/1997	10/31/1997	8	skin biopsy-pending;	PVT	PVT	Elavil, Siremet, Parlodel, Clonidine, Prinvil, Bepal	NONE	NKDA, Parkinson, sz disorder, CVA, HTN, Zestoretic;	pt devel rash @ 79yr old w/flu vax dose 1;~ ()~~~In patient		1						1	Petechiae; Vasculitis	FLUX~UNKNOWN MANUFACTURER~4978679~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0104619	11/12/1997	MA	56.0	56		F	11/02/1997	3hr p/vax pt heart started to race & go into AV fibrillation;hosp for tx in ICU;				Y	Y	2			Y	10/24/1997	10/24/1997	0		OTH	OTH	Betapace-Prilosic;Propulsid, Zocor;	NONE	arthritis-AO fibliration-undercontrol;	NA~ ()~~~In patient		1						1	Tachycardia; Ventricular fibrillation	FLU3~CONNAUGHT LABORATORIES~7F81793~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0104621	11/12/1997	NY	70.0	70		F	11/03/1997	felt fine till 10PM evening devel progressive SOB, gasping for breath over period of 2hr worsened by lying down;went to ER given 02;adm next day noticed red blotches on legs not itchy;MD unsure if linked to vax;					Y	3			Y	10/21/1997	10/21/1997	0		OTH	PUB	Clonadine, altace, prilosec, atrovent inh, serevent inh	emphysema-chronic stable	emphysema, HTN, GI ? ulcer	~ ()~~~In patient		1						1	Dyspnoea; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~7F81799~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0104630	11/12/1997	TX				F	10/21/1997	flu vax & pnu-immune mixed in same syringe & inj into one site & pt devel cellulitis & was hosp;this is 1 of 2 pt from this site to devel cellulitis p/vax;					Y				Y	10/15/1997				OTH	OTH	unk	unk		~ ()~~~In patient	897296037L	1						1	Cellulitis	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0104638	11/12/1997	MN	52.0	52		F	11/07/1997	rt deltoid lump @ inj site w/erythema & pruritus;				Y					Y	10/27/1997	10/29/1997	2		PUB	PUB	iuethotrexate	rheumatoid arthritis (on methotrexate)	sertraline,tetracycline, macrolides,cephamycins, cephlasporins	pt exp localized rxn in 1996 @ 51yr old w/flu vax;~ ()~~~In patient	MN97046A	1						1	Injection site mass; Pruritus; Rash	FLU3~PFIZER\WYETH~4978168~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104639	11/12/1997	IN	50.0	50		F	11/05/1997	29OCT97 deltoid sore to touch, no hurt when move-knot could be felt @ inj site;3NOV97 deltoid sore to touch, no hurt when move arm;knot same as 29OCT97 15mm x 17mm;area around knot red & warm to touch;4NOV97 knot present;welt inj site;				Y					N	10/27/1997	10/29/1997	2	NONE	PUB	PUB	Seldane	NONE	NKA-No known medical conditions	NONE~ ()~~~In patient	IN97036	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4978174~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~7F91679~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0104640	11/12/1997	OH	2.0	2	.1	M	10/31/1997	presents w/parotitis 2wk p/vax;mom claims cough (non prod) & low grade fever began day p/vax & has cont;				Y					N	10/14/1997	10/30/1997	16	sent viral pharyngeal cult; r/o CMV parainfluenza;	PUB	PUB		NONE	dairy allergy	~ ()~~~In patient	OH98040	1						1	Cough; Infection; Pyrexia; Sialoadenitis	DTAP~CONNAUGHT LABORATORIES~7L81673~4~~RL~DTAP (TRIPEDIA)~1|FLU3~PFIZER\WYETH~4978190~2~~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HIBV~PFIZER\WYETH~M195RC~4~~LL~HIB (HIBTITER)~1|MMR~MERCK & CO. INC.~0283E~1~~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0104641	11/12/1997	MD	32.0	32		F	11/03/1997	pt recv vax 31OCT97 2PM & 31OCt97 about 6PM became nauseated then vomited;intermittent vomiting cont 1NOV97 & 2NOV97;seen in ER evening of 2NOV(7 stated had some trouble breathing;take fluids;not admitted;3NOV97 still some vomiting;				Y					U	10/31/1997	10/31/1997	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MD97016	1						1	Dehydration; Dyspnoea; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E3287GG~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0104642	11/12/1997	MS	36.0	36		F	10/15/1997	next day achy, fever, n/v, diarrhea felt sick for 3 days;now 1wk later has achy joints, sore throat;									Y	10/08/1997	10/09/1997	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MS97049	1						1	Arthralgia; Diarrhoea; Malaise; Myalgia; Pharyngitis; Pyrexia; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E3287GB~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104643	11/12/1997	LA	26.0			F	11/05/1997	flu sx x 2 days;sore throat-back aches-temp 102;									N				NONE	OTH	OTH				~ ()~~~In patient		1						1	Influenza; Myalgia; Pharyngitis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104645	11/12/1997	MA	50.0	50		F	11/06/1997	sore @ inj site-wave of nausea-throat pain, ear pressure, watery eyes;									Y	11/05/1997			NONE	UNK	UNK				~ ()~~~In patient		1						1	Ear pain; Injection site pain; Lacrimal disorder; Nausea; Pharyngitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104647	11/12/1997	MN	52.0	52		F	11/10/1997	scratchy throat, legs ached, lower back hurt, itchy puffy under lt eye;rx ATB sx of conjunctivitis poss herpes simplex;				Y					Y	10/28/1997	10/29/1997	1	cult-positive herpes simplex;anti-viral meds given;	OTH	OTH	Trifloridine eye drops	cold	NONE	~ ()~~~In patient		1						1	Back pain; Conjunctivitis; Face oedema; Herpes simplex; Myalgia; Pharyngitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0104649	11/12/1997	OR	53.0	53		F	11/06/1997	pt recv vax 30OCT97 &  31OCT97 pt reported 2-3 hard area @ inj site;hot;no visible swelling or discoloration;c/o pain/stiffness radiating into shoulder/upper back/neck;				Y					U	10/30/1997	10/30/1997	0		OTH	OTH		NONE		~ ()~~~In patient		1						1	Back pain; Hypotonia; Injection site hypersensitivity; Injection site mass; Neck pain; Nuchal rigidity; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4978213~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104652	11/12/1997	MA	54.0	54		M	11/03/1997	pt went to ER feeling allergic rxn;diff breathing & swelling 23OCT97;tx pred;				Y					Y	10/22/1997	10/22/1997	0		PVT	UNK		routine diabetic check-up	diabetes, high cholesterol	~ ()~~~In patient		1						1	Dyspnoea; Hypersensitivity; Oedema	FLU3~CONNAUGHT LABORATORIES~7F81793~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0993E~UNK~IM A~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0104653	11/12/1997	OH	31.0	31		F	11/06/1997	23OCT flu vax c/o sore throat later in PM;24OCT hives @ inj site in AM progressing to hands & feet, fatigue, sore arm, inc throat pain;25OCT unable to talk diff swallowing, gen urticaria;went to an ED given IV DPH, solumedrol, tigan				Y					Y	10/23/1997	10/25/1997	2		PUB	PVT	unk	NONE	allergic to  PCN, codeine, novacaine;migraine h/a, endometriosis	pt exp rxn as child w/MMR ? age;~ ()~~~In patient		1						1	Asthenia; Injection site hypersensitivity; Laryngospasm; Pain; Pharyngitis; Speech disorder; Urticaria	FLU3~PFIZER\WYETH~7F81856~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104657	11/12/1997	WI	50.0	50		F	11/06/1997	pt stated approx 4hr p/vax had swelling, redness & warmth lt deltoid to elbow & lt deltoid to neck nodes;				Y					Y	11/04/1997	11/04/1997	0	NONE	PVT	PVT	Lasix;Premain;Mavik;Troprolal;Amitriptyline		multiple sclerosis, HTN, migraines;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Lymphadenopathy; Oedema peripheral; Vasodilatation	FLU3~PFIZER\WYETH~4978149~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104658	11/12/1997	WI	48.0	48		M	11/06/1997	urticaria on 28OCT97;tongue swelling, laryngospasm 29OCT to ER urticaria cont 30OCT97 to MD office;tx DPH, Zantac, Zytlex;pred;				Y					Y	10/27/1997	10/28/1997	1	NONE	PVT	PVT	Insulin	NONE	diabetes/pistachio, caraway seed allergies	NONE~ ()~~~In patient		1						1	Laryngospasm; Tongue disorder; Urticaria	FLU3~PFIZER\WYETH~4978141~7+~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104660	11/12/1997	CA	75.0	75		F	11/03/1997	diarrhea 22 & 23OCT97 nausea, chills 24OCT through 31OCT severe earache & h/a;MD prescribed Tetracycline & entex-also sinusitis & fever;examined by MD on 30OCT97				Y					Y	10/21/1997	10/22/1997	1		OTH	OTH		NONE	angina-bronchial asthma;	~ ()~~~In patient		1						1	Chills; Diarrhoea; Ear pain; Headache; Nausea; Pyrexia; Sinusitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0104661	11/12/1997	MI	66.0	66		F	11/03/1997	large site rxn 7.5x9cm red, raised area;extremely pruritic, indurated;				Y					Y	10/29/1997	10/30/1997	1		PVT	PVT	Tenoretic;Minipress;Klotrix;Miatalen	NONE	HTN, osteoporosis;all: erythromycin;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81816~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~448455~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0104662	11/12/1997	AZ	45.0	45		M	11/04/1997	approx 40min p/vax had onset of swelling lower lt side lip;no airway compromise;DPH & epi given;				Y					Y	11/04/1997	11/04/1997	0		MIL	MIL	pt recv MMR/OPV/TD vax on 4SEP97		allergy to sulfa drugs	~ ()~~~In patient		1						1	Face oedema	FLU3~PFIZER\WYETH~4978176~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104664	11/12/1997	MA	18.0	18		M	11/04/1997	severe local rxn to pneumovax fever & vomiting problem secondary to rxn;Ibuprofen, ice applications;				Y					Y	10/29/1997	10/29/1997	0		PVT	UNK		maxillary sinusitis	asthma	~ ()~~~In patient		1						1	Injection site reaction; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~7581793~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~0993E~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0104667	11/12/1997	FL	48.0	48		F	10/23/1997	devel hives & itching 22OCt97 11PM took/DPH @ 655AM 23OCT97;pt contacted p/hr c/o swelling, itching face, throat tight;no SOB;chest hurting, tight;				Y						10/22/1997	11/22/1997	31	NONE	PVT	UNK	Claritin	NONE	NONE	pt did recv flu 10/24/96 without reported adverse/allergic rxn~ ()~~~In patient		1						1	Chest pain; Laryngospasm; Oedema; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4878200~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104670	11/12/1997	IL	60.0	60		F	11/04/1997	throat closing;hands & feet turning red & itchy;joints hurting;red & swelling where shot was given;				Y					Y	10/21/1997	10/22/1997	1		PUB	UNK	Pred;Premarin		lupus	~ ()~~~In patient		1						1	Arthralgia; Injection site hypersensitivity; Injection site oedema; Laryngospasm; Pruritus; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0104672	11/12/1997	VA	68.0	68		F		10cm x 12cm area of raised, shiny, well demarcated erythema w/warmth, over rt deltoid region began 36hr p/vax in this arm;tx as probable cellulitis w/keflex;lt arm swollen/red/warm to touch, sore;mild discomfort, sweaty & feverish;				Y					Y	10/24/1997	10/26/1997	2	NA	PVT	PVT	Prempro;synthroid;Naprosyn	NO T97.9;	NIKA/hypothyroid/hypercholesterolemia	unk~ ()~~~In patient		1						1	Cellulitis; Hyperhidrosis; Injection site hypersensitivity; Injection site oedema; Injection site pain; Rash maculo-papular; Skin striae; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81788~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~444068~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0104676	11/12/1997	IL	47.0	47		F	11/05/1997	pt recv vax 27OCT97;28OCT97 pt devel 1 1x3cm hard, hot, red welts @ inj site;saw MD who prescribed ice to site;MD did not feel this was an allergy;									Y	10/27/1997	10/28/1997	1		PUB	UNK		NONE	grass & ragweed allergy;food allergy, oats, peanuts, choclate	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~6~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104678	11/12/1997	CO	40.0	40		F	10/31/1997	dizziness, nausea, vomiting, extremity sore arm, spots on eyelids;									Y	10/30/1997	10/30/1997	0	NONE	PUB	UNK		NONE	codeine	~ ()~~~In patient		1						1	Dizziness; Pain; Rash; Vomiting	FLU3~PFIZER\WYETH~4978165~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104679	11/12/1997	AL	60.0	60		F	11/06/1997	feeling dizzy, nauseous, faint, flu sx, fever, aching, sore throat, stopped up head & throat, swollen arm where shot was administered;almost had to go to ER									Y	10/22/1997	10/22/1997	0		OTH	PUB	NONE	NONE	allergic to latex	~ ()~~~In patient		1						1	Dizziness; Influenza; Injection site oedema; Myalgia; Nausea; Pharyngitis; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104680	11/12/1997	OR	44.0	44		F	10/29/1997	11:25AM pt recv vax & 450PM pt c/o 1 x2cm rash on face & swelling eyelids;pt went home took med;no no c/o adverse effects;									Y	10/29/1997	10/29/1997	0	NONE	UNK	UNK		NONE	TCN, esophageal spasms;	~ ()~~~In patient		1						1	Face oedema; Rash	FLU3~PFIZER\WYETH~4978213~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104681	11/12/1997	CT	72.0			M	10/29/1997	rash, red patches, sl elevated on belly part of abd, legs, rt & lt near thighs, behind knees, spotty on one leg to ankles;chronic dermatitis around neck & shoulders exacerbated;rash itch;rash still running its course;									N				egg sensitivity ruled out;sensitivity to thimerosal suspected	PVT	UNK	serevent;flovent	NONE	atopic neurodermatitis (mild) scalp, facial area;	pt exp major eruption skin in face, neck, scalp area cracked skin @ 68yr old w/t~ ()~~~In patient		1						1	Condition aggravated; Pruritus; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104682	11/12/1997	MA	55.0	54		F	11/05/1997	hives devel about 5hr p/vax spreading across shoulders, neck & back & a rash appeared on abd;the hives manifested as a bumpy, faintly itchy skin condition that peaked in about 24hr but took a wk to subside altogether;									Y	10/29/1997	10/29/1997	0	NONE	PUB	OTH	Premarin;HRT	NONE	NONE	NONE~ ()~~~In patient		1						1	Pruritus; Rash maculo-papular; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81793~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104683	11/12/1997	MA	74.0	74		F	11/06/1997	the next day very tired, 2nd day sniffles aching muscles above knees-stiffness all over;3rd day dizziness very odd all of above;p/10 day MD appt vertigo given rx;nausea, no appetite, vision-h/a, forehead;									Y	10/17/1997	10/18/1997	1	NONE	PUB	UNK		NONE	high blood pressure	NONE~ ()~~~In patient		1						1	Anorexia; Asthenia; Headache; Hypertonia; Nausea; Rhinitis; Vertigo; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104684	11/12/1997	MA	43.0	43		F	11/05/1997	immun given 17NOV97 afternoon & 3AM devel hives & intense itching lt arm where recv inj;no other sx;hives left arm only lasted 24-36hr;									Y	11/17/1997	11/18/1997	1		PVT	PVT				~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~4978144~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104685	11/12/1997	WA	44.0	44		F	11/05/1997	pt c/o pain in rt upper arm & axilla;Ibuprofen & hot packs;									N	10/29/1997	10/30/1997	1	NONE	OTH	OTH	Hormones	NONE	NONE	~ ()~~~In patient		1						1	Injection site pain; Lymphadenopathy	FLU3~CONNAUGHT LABORATORIES~7F81868~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104686	11/12/1997	CA	61.0	61		F	11/10/1997	pt recv vax 14OCT97 & on f/u day devel fever of 103 & was weak & very disoriented;lasted for 5 days then began to slowly recover;felt extremely ill;arm very sore for 5 days p/vax;									Y	10/14/1997	10/15/1997	1		OTH	PVT	Premarin, Zolft;Triamterene		PCN;borderline high BP	NONE~ ()~~~In patient		1						1	Asthenia; Confusional state; Malaise; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0104687	11/12/1997	MI	72.0	72		M	11/03/1997	3 large blotches caused by pneumonia vax placed in rt arm;									N	10/24/1997	11/26/1997	33		PVT	PUB				~ ()~~~In patient		1						1	Rash maculo-papular	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0104688	11/12/1997	MI	69.0			F	11/02/1997	red round circle size of a fifty cent piece also a sl itch lasted 2 days;caused by the pneumonia vax placed in rt arm;									Y	10/24/1997	10/25/1997	1		OTH	PUB	Provachol-Lasix;Hytrin-EC naprosyn	NONe	bronchitis	~ ()~~~In patient		1						1	Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0104689	11/12/1997	MO	49.0	49		F	10/27/1997	pt recv vax 22OCT97 12:99 & 23OCT pt had clonic tonic sz Dilantin level was subtherapeutic;									Y	10/22/1997	10/23/1997	1	free phenytoin;therapuetic range 102;	OTH	UNK			sz-hx multitrauma	~ ()~~~In patient		1						1	Condition aggravated; Convulsion	FLU3~PFIZER\WYETH~4978203~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104690	11/12/1997	MO	49.0	49		F	11/06/1997	about 5hr p/vax called & had blotches on ant neck & chest;started  by phone on DPH & zyrtec;by next day had diffuse hives;had inc swelling in arm;										11/04/1997	11/04/1997	0		PVT	PVT				~ ()~~~In patient		1						1	Oedema peripheral; Rash maculo-papular; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E3277GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~442519~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0104691	11/12/1997	WI	4.0	4		M	11/05/1997	local redness, swelling, warm to touch approx 3 diameter;no fever;mom to ice area-call if no improvement;									Y	10/30/1997	10/31/1997	1		PVT	PVT				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4978206~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104692	11/12/1997	CO	77.0	77		F	11/05/1997	severe aches in back, legs, arms for 1 1/2 days;									Y	10/23/1997	10/24/1997	1	NONE	PVT	UNK			HTN, COPD, diabetes;	~ ()~~~In patient		1						1	Myalgia	FLU3~CONNAUGHT LABORATORIES~7F81757~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104694	11/12/1997	CA	82.0	82		U	11/06/1997	terrible h/a, runny nose, back aches, hacking cough & nausea;It lasted about 1wk w/sx diminishing p/about the third day x/for hacking cough;									Y	10/16/1997	10/23/1997	7	NONE	UNK	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						1	Back pain; Cough; Headache; Nausea; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104696	11/12/1997	CA	54.0	53		F	11/03/1997	T101;h/a, chills on 29OCT97 for approx 24hr;felt fine 28OCT97;									Y	10/27/1997	10/29/1997	2	NONE	PUB	PVT	Glucosamine HCL;Naproxen, ASA	NONE	NONE	NONE~ ()~~~In patient		1						1	Chills; Headache; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4978189~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104698	11/12/1997	OH	33.0	33		F	11/03/1997	3NOV97 pt came to the clinic c/o hives & itching;hives noted on chest, shoulders, back & abd;instructed that areas must be covered while @ work, DPH, hydrocortisone cream & f/u w/MD if needed;									Y	10/31/1997	11/01/1997	1	NA	PUB	PVT	multi vit-centerim	denies any	denies any	denies~ ()~~~In patient		1						1	Pruritus; Urticaria	FLU3~PFIZER\WYETH~4978192~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104699	11/12/1997	FL	68.0			M		pt suffered w/local pain, fever, chills & gen malaise;fever lasted approx 2 days;									Y	10/17/1997	10/17/1997	0		PVT	PVT	unk	NONE	unk	NA~ ()~~~In patient		1						1	Chills; Injection site pain; Malaise; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104706	11/12/1997	MS	56.0	56		F	10/31/1997	pt recv vax 30OCT97 & approx 4:30PM gen edema @ site, warm to touch & tender to site;BP 106/70									U	10/30/1997	10/30/1997	0		PUB	UNK	Synthroid, Librax, Enderal, Premarin	NONE	fibromyalgia & mitral valve prolapse	~ ()~~~In patient		1						1	Hypotension; Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3287GB~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0585D~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0104708	11/12/1997	MT	47.0	47		F	10/24/1997	24-27hr p/vax pt began to run a fever of 102 & exp chills;area around inj site of lt arm became inflamed 4 1/2 x 3 area;warm to touch & tender;pt denies exp hives or dyspnea;pt states swelling & tenderness has since gone;									Y	10/21/1997	10/22/1997	1	NA	PUB	PUB	Insulin	NONE	diabetes	~ ()~~~In patient	MT97017	1						1	Injection site hypersensitivity; Injection site inflammation; Injection site pain; Oedema; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4978159~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~444072~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0104709	11/12/1997	FL	49.0	49		M	11/05/1997	w/in 1/2hr pt started having pain in the inj area;there was a 10inch diameter of local pain around inj area;pt suffered pain in movement of shoulders;approx 6hr later had a fever of 103, chills, & gen malaise;fever & chills lasted 48hr;									Y	10/17/1997	10/17/1997	0	NA	PVT	PVT	vasetec	NONE	NONE	NA~ ()~~~In patient		1						1	Chills; Injection site pain; Malaise; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104710	11/12/1997	FL	70.0			F	11/05/1997	pt c/o fever lasting for 2 days chills & gen malaise;									Y	10/17/1997	10/17/1997	0	NA	PVT	PVT	unk	NONE	unk	NA~ ()~~~In patient		1						1	Chills; Malaise; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104712	11/12/1997	ME	45.0	44		F	10/27/1997	chest tightness, dizziness, lightheaded, achy across shoulders, hoarseness 15-18hr 3hr p/vax given;									Y	10/21/1997	10/21/1997	0		OTH	UNK	BCP		HBIG recombivax Recombivax /HB	pt exp rash upper torso & neck w/hep B dose 1;~ ()~~~In patient		1						1	Chest pain; Dizziness; Dysphonia; Myalgia	FLU3~CONNAUGHT LABORATORIES~7F81817~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104713	11/12/1997	WV	30.0	30		F		no fever @ home 99.0a;MD ofc 23OCT;swelling under lt arm then under upper arm felt swelled but no redness;could not see swelled area could feel the swelling when moving arm;next day blotchy red area;dx cellulitis;pt concerned allerg to vax;									Y	10/21/1997	10/23/1997	2	no lab tests;	PUB	PUB		NONE	allergies to pollens & other house hold materials, irritable bowel;	pt exp joint pain @ 29yr old w/flu dose 1~ ()~~~In patient	WV9720	1						1	Arthralgia; Cellulitis; Hypersensitivity; Lymphadenopathy; Rash maculo-papular	FLU3~MEDEVA PHARMA, LTD.~E20047KC~2~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104633	11/13/1997	FL	21.0	21		F	11/12/1997	progressive distal>proximal bilat LE & UE numbness & weakness, loss of reflexes;on day #8-9 p/some bilat facial nerve palsy;no further progression p/then IV IG given;dx by neurologist=probable GBS;					Y	8			N	10/20/1997	10/28/1997	8	LP negative;MRI negative for MS;lupus w/u negative;nerve conduction studies equivocal;extensive other labs nl;	OTH	OTH	occas OTC APAP & Ibuprofen;	NONE	had abd cramps/fatigue/prob GE 15OCT-16OCT, tatoo 6OCT;	~ ()~~~In patient		1						1	Asthenia; Facial palsy; Guillain-Barre syndrome; Hyporeflexia; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E3277GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0104634	11/13/1997	ME	70.0	70		F	11/11/1997	pt recv vax SEP97 & pt devel GBS 1mo p/vax;approx 14OCT97 pt exp rt leg weakness that progressed to profound rt leg weakness;sx persist as of the time of report 6NOV97;reportedly pt had no prior hx of GBS;	Y		Y	Y	Y	5			N	09/18/1997	10/14/1997	26		PVT	PVT				~ ()~~~In patient	CO7737	1						1	Asthenia; Guillain-Barre syndrome; Hypokinesia; Hyporeflexia; Muscle atrophy; Myasthenic syndrome; Paralysis; Guillain-Barre syndrome; Hypokinesia; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~7F81854~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7F81854~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0104724	11/13/1997	OR	20.0	20		F	10/23/1997	arm red elbow to shoulder itching;DPH given c/o SOB;epi given;c/o throat discomfort;improved p/epi;				Y					Y	10/21/1997	10/21/1997	0		PVT	PVT		NONE		~ ()~~~In patient		1						1	Dyspnoea; Laryngospasm; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81862~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0104725	11/13/1997	GA	47.0	47		F	11/04/1997	pain-red, blister @ or near inj site 2wk ago-possible relation to vax, but doubtful;									Y	10/15/1997	11/03/1997	19	NONE	UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104726	11/13/1997	MA	55.0	55		F	11/05/1997	intense itching lt upper arm around inj site 4x 6 area erythema;										10/30/1997	10/30/1997	0		PVT	PVT	none			~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~4578144~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104727	11/13/1997	MA	62.0	62		F	11/05/1997	inc warmth, redness, inc itching of inj site & entire lt arm devel the evening p/vax;									Y	10/15/1997	10/15/1997	0		PVT	PVT				~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4978144~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0490E~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0104728	11/13/1997	MD	54.0	54		M	11/06/1997	significant pain in lt upper arm muscle persistent for over 3wk so far;no bruising or swelling noticed;									N	10/15/1997				PUB	UNK		NONE		~ ()~~~In patient		1						1	Myalgia	FLU3~PFIZER\WYETH~4978167~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104729	11/13/1997	NV	73.0			M	10/30/1997	pt recv vax 13OCT97 & on 15-16OCT pt devel gen skin rash;									Y	10/13/1997	10/15/1997	2	NA	PUB	OTH	NONE	NONE	unk	~ ()~~~In patient		1						1	Rash	FLU3~PFIZER\WYETH~4978189~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104730	11/13/1997	NV	36.0	36		F	11/03/1997	soreness in neck it became stiff;aching all over body, sore throat, stuffy nose;flu like sx appeared;									Y	10/15/1997	10/15/1997	0	NONE	OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Influenza; Myalgia; Neck pain; Nuchal rigidity; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~7F81868~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104731	11/13/1997	OR	67.0	66		F	10/06/1997	Wednesday evening (day of inj) lt arm swollen, red, sore & hot;had chills;2OCT97 noon swelling moved to inner aspect of arm;3OCT97 1130AM saw MD who dx moderate allergic rxn;recommends DPH;				Y					Y	10/01/1997	10/01/1997	0		PUB	PUB	Premarin;Vitamins & calcium	NONE	allergies: PCN, percocet	NONE~ ()~~~In patient	OR9721	1						1	Chills; Oedema peripheral; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4978146~7+~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0001D~2~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0104732	11/13/1997	MA	68.0	68		F	11/11/1997	the noc of flu vax pt felt cold & hot;never felt good rest of the wk, feverish & chills on the weekend;went to MD 3NOV because of chills & fever;found no visible infect;no urinary infect either;									Y	10/28/1997	10/28/1997	0	urinary analysis ashowed no infect	OTH	PUB	NONE			~ ()~~~In patient		1						1	Chills; Malaise; Pyrexia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104734	11/13/1997	OH	61.0	61		F	11/10/1997	pt recv ax 3NOV97 & 2 days later on the 5th of NOV lt tender area;mild lt clavicle;no fever, no aching, no n,v,d;small tender bruise lt arm, negative redness;									Y	11/03/1997	11/05/1997	2		PUB	PVT			PCN	~ ()~~~In patient		1						1	Back pain; Ecchymosis; Pain	FLU3~CONNAUGHT LABORATORIES~7F81896~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104736	11/13/1997	SC	52.0	52		F	11/03/1997	states began hurting in lt arm, lt shoulder & chest on evening p/vax;redness & swelling of lt arm began 48hr p/along w/fever of 100 until today 3NOV97 arm still ached from elbow to shoulder;swollen & red 3 1/2 x 3 T100;saw MD;				Y						10/30/1997	10/30/1997	0	NONE	PUB	PUB	Ortho-EST	NONE	unk	pt sibling devel severe swelling of arm @ 40+ w/tetanus~ ()~~~In Sibling	SC97077	1						1	Myalgia; Oedema peripheral; Pain; Pyrexia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3287GH~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~CONNAUGHT LABORATORIES~7C91583~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0104738	11/13/1997	SC	41.0	41		F	10/20/1997	pt recv vax 14OCT97 & returned to clinic c/o arm stinging & burning;area redness size 1/2 dollar noted;no other complaints;arm still red & swollen on 15OCT97;some sl redness still present 17OCT97;									Y	10/14/1997	10/14/1997	0	NONE	PUB	PUB		NONE		~ ()~~~In patient	SC97062	1						1	Oedema peripheral; Pain; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3287GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104740	11/13/1997	SC	38.0	38		M	11/04/1997	pt recv vax 17OCt97;states pain in arm started Tuesday AM 21OCt97 & progressively moved to shoulder;seen by PMD  & referred to specialist in another county d/t improvement;states has knot in arm but RN unable to feel today;				Y					N	10/17/1997	10/21/1997	4		PUB	PUB	Tylox;Antibiotic	NONE	NONE	~ ()~~~In patient	SC97074	1						1	Pain; Skin nodule	FLU3~MEDEVA PHARMA, LTD.~E3287GA~3~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~CONNAUGHT LABORATORIES~6181392~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0104741	11/13/1997	SC	53.0	53		F	10/24/1997	rt arm has red, swollen area 1 1/2 x 1 1/2 extremely tender to touch, has muscle aches all over esp legs & lower back;has had a severe h/a since onset of sx, nauseated but better 23OCT97;fever now 23OCT97 102;24OCT97 feeling much better;									U	10/21/1997	10/22/1997	1		PUB	PUB		NONE	hx of magraine;	~ ()~~~In patient	SC97065	1						1	Back pain; Headache; Lymphadenopathy; Myalgia; Nausea; Oedema peripheral; Pyrexia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3287GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1173E~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0104743	11/13/1997	SC	16.0	15		F	10/20/1997	mom reported throat hurting, swollen @ 630AM today;nauseated-sleeping;T98.6 arm hurting from time shot given to present;no redness/swelling;diabetic BS 270-300;21OCT97 arm still sore throat fine/other problem resolved;									Y	10/19/1997	10/20/1997	1	NONE	PUB	PUB			diabetic	~ ()~~~In patient	SC97063	1						1	Condition aggravated; Hyperglycaemia; Laryngeal oedema; Nausea; Pain; Pharyngitis; Pyrexia; Somnolence	FLU3~MEDEVA PHARMA, LTD.~E3287GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104745	11/13/1997	SC	39.0	39		M	10/27/1997	sinus drainage then moved to drainage in chest;23OCT97 fever 102.2, chills went home early wed, thurs & of Friday reported 27OCT;still feels sluggish;has had bad coughing attack had to sit up									N	10/15/1997	10/23/1997	8	pre-drawn	PUB	OTH	NA		allergies to tea (decaffinated) no asthma etc	~ ()~~~In patient	SC97071	1						1	Chills; Cough; Lung disorder; Malaise; Pyrexia; Sinusitis	FLU3~MEDEVA PHARMA, LTD.~3287GA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104746	11/13/1997	SC	57.0	57		F	10/31/1997	pt states noted swelling & bruising on arm on 25OCT97;called CHD & told to come in 26OCT97 lt arm from shoulder to elbow red, swollen & hot to touch;some red streaking noted;bruised area noted just below inj site & extending to inner arm;				Y					Y	10/23/1997	10/25/1997	2		PUB	OTH	NONE	NONE	NONE	~ ()~~~In patient	SC97076	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Skin striae; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3287GH~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~CONNAUGHT LABORATORIES~7C91583~2~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0104751	11/13/1997	WA	55.0	55		F	10/22/1997	both hands swollen felt on fire-trouble sleeping;both ankles extremely sore;lt shoulder joint very sore;									Y	10/16/1997	10/17/1997	1		PVT	PVT		NONE	irritable bowel synd	NONE~ ()~~~In patient		1						1	Arthralgia; Insomnia; Oedema peripheral; Pain	FLU3~PFIZER\WYETH~4978213~5~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104752	11/13/1997	UT	53.0	53		F	10/23/1997	pt noticed tenderness & redness @ inj site;redness extended down back of lt arm approx 4-5inches from inj site;in addition to redness down arm, area was hot to touch;									Y	10/22/1997	10/22/1997	0		PUB	PUB		NONE		~ ()~~~In patient	UT972234	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4978146~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0332D~1~SC L~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0104718	11/14/1997	GA	65.0			M	11/10/1997	pt recv vax & pt exp serum sickness, nephritis & hosp for 10 days;					Y	10			U					UNK	UNK			allergy sulfa;	~ ()~~~In patient	WAES97101775	1						1	Nephritis; Serum sickness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0104721	11/14/1997	IN				M	10/23/1997	this plaintiff allegedly sustained permanent eye damage & was otherwise injured p/vax;								Y	N	10/11/1995				OTH	OTH	unk	unk		~ ()~~~In patient	897309005L	1						1	Eye disorder; Visual disturbance; Visual field defect	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0104756	11/14/1997	MA	53.0	53		F	11/07/1997	itching;eye redness w/discharge;throat pain, some swelling 4hr p/vax;peeling oral mucosa 2 days p/vax;				Y					Y	10/28/1997	10/28/1997	0	NONE	PUB	PUB	Fosamox	NONE	osteoporosis, breast cancer	pt exp hives p/childhood vaxs~ ()~~~In patient	MA9727	1						1	Conjunctivitis; Lacrimal disorder; Laryngospasm; Mucous membrane disorder; Pharyngitis; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81793~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0104758	11/14/1997	KY	45.0	45		F	11/12/1997	arm swelled, red, feverish for several days turning into bruise, flu like sx, achy body, fever, chills immed p/vax;				Y					N	10/01/1997	10/01/1997	0	NONE	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Chills; Ecchymosis; Influenza; Myalgia; Oedema peripheral; Pyrexia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0104759	11/14/1997	TX	32.0	32		F	11/13/1997	swelling in neck & throat area-hives neck, chest & upper arm;DPH, steroid, adrenaline;				Y					Y	11/12/1997	11/13/1997	1		OTH	OTH	Flexeril	NONE	codeine	pt exp rxn @ 5yr old w/smallpox;~ ()~~~In patient		1						1	Lymphadenopathy; Oedema; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0104760	11/14/1997	IL	53.0	53		F	11/13/1997	24hr post vax chills, fever, aches in joints, nausea, dizzy, diarrhea, felt unwell;									Y	10/28/1997	10/29/1997	1	NONE	PVT	PUB	Zocar	NONE	NONE	~ ()~~~In patient		1						1	Arthralgia; Chills; Diarrhoea; Dizziness; Malaise; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104771	11/14/1997	NY	85.0	85		F	11/07/1997	RA swollen, numbness burning @ inj site;Friday pt could not sleep;MD recommended;APAP given;				Y					Y	10/31/1997	10/31/1997	0		OTH	PUB	Meprobomate;Coumadine;Issocorbic;Lacess;		solmovitz MD	~ ()~~~In patient	BA97029	1						1	Injection site oedema; Injection site pain; Insomnia; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E20017HC~7+~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0815D~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0104772	11/14/1997	NY	82.0	81		F	11/07/1997	pt feels pain throughout the body;SOB, dry mouth, not able to sleep & when down feel lke was choking;pt has no pain @ the inj site;				Y					Y	10/21/1997	10/22/1997	1	EKG & XRAY	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	BA97028	1						1	Dry mouth; Dysphagia; Dyspnoea; Insomnia; Pain	FLU3~MEDEVA PHARMA, LTD.~E20017HC~2~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0104774	11/14/1997	NJ	42.0	42		F	10/28/1997	pain in lt arm, back, chest several hr p/vax;									U	10/10/1997	10/10/1997	0	NONE	PUB	PUB	unk	unk	hx of tendonitis in elbow/left	pt sibling exp rxn @ 35yr old w/flu~ ()~~~In Sibling	NJ9741	1						1	Back pain; Pain	FLU3~CONNAUGHT LABORATORIES~7F81916~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104775	11/14/1997	NJ	44.0	44		F	10/28/1997	pt recv vax 10AM on 24OCt97 @ noon devel vomiting, diarrhea & fever 102;				Y					Y	10/24/1997	10/24/1997	0	compazine & IV @ MD office	PUB	UNK		NONE	hx of sinus problems-no on any meds	unk~ ()~~~In patient	NJ9740	1						1	Diarrhoea; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81916~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0104777	11/14/1997	SC	39.0	39		M	11/03/1997	pt states recv vax 31OCT97 around 11AM;friday noc feet fine but Saturday morning woke up w/red rash on face, under eyes, temple area, & on neck;felt hot, like skin drawing up;took PDH;									Y	10/31/1997	11/01/1997	1		PUB	PUB	takes arthritis pill;	NONE	numerous allergies-resp sinus problems;	~ ()~~~In patient	SC97073	1						1	Rash; Skin disorder; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3287GH~2~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104778	11/14/1997	SC	52.0	51		F	10/28/1997	lt arm became sore that noc;saturday morning lt arm was sore, red & swollen & pt was running a temp around 101 to 101.6;arm was still red & swollen;				Y					N	10/24/1997	10/25/1997	1	NONE	PUB	PUB	NONE	NONE	colitis	NONE~ ()~~~In patient	SC97072	1						1	Oedema peripheral; Pain; Pyrexia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3287GH~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~CONNAUGHT LABORATORIES~7C91583~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0104782	11/14/1997	NJ	47.0			M	11/10/1997	1NOV97 2PM watery diarrhea;8PM rash on hips (red papules);9PM given DPH;2NOV97 rest;									Y	10/31/1997	11/01/1997	1	NA	OTH	PVT	Zantac	hictel hemia	hx of tx w/slulf drugs for coelic sprue			1						1	Diarrhoea; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~7F81916~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~SMITHKLINE BEECHAM~542A6~1~~RA~HEP A (HAVRIX)~1|YF~CONNAUGHT LABORATORIES~7H81828~1~~LA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0104783	11/14/1997	SC	23.0	23		F	10/27/1997	6 days p/vax started having coughing w/sputum production, real bad head congestion, nasal stuffiness, runny nose, & h/a;									Y	10/17/1997	10/23/1997	6		PUB	PUB		NONE	NONE	~ ()~~~In patient	SC97066	1						1	Cough; Headache; Productive cough; Rhinitis	FLU3~MEDEVA PHARMA, LTD.~E3287GA~3~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104634	11/17/1997	ME	70.0	70		F	11/11/1997	GBS onset of sx of leg weakness mid October poss earlier-unable to bear weight;rx w/Iv immune globulin;sx now improving but still unable to ambulate independently;			Y	Y	Y	5			N	09/18/1997	10/10/1997	22	EMG's confirmed dx;	PVT	PVT		NONE	alzheimer's dementia, hx TIa, HTN, Dm;	~ ()~~~In patient		1						2	Asthenia; Guillain-Barre syndrome; Hypokinesia; Hyporeflexia; Muscle atrophy; Myasthenic syndrome; Paralysis; Guillain-Barre syndrome; Hypokinesia; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~7F81854~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7F81854~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0104789	11/17/1997	OK	65.0	65		M	10/27/1997	23OCT97 c/o muscular aches that PM went to sleep @ 10PM;awakened by wife 11PM;stated felt okay;24OCt97 1230AM wife was awakened by bed shaking pt having sz-non responsive;taken to ER combative & disoriented 1-2hr;afeb;adm to hosp for test;				Y	Y				Y	10/23/1997	10/24/1997	1	24OCT97 CT negative;lab studies inc CPK, EEK, pending;	PUB	PUB	takes ziac	NONE	HTN controlled w/med		OK9738	1						1	Blood creatine phosphokinase increased; Confusional state; Convulsion; Hostility; Myalgia; Stupor; Tremor	FLU3~MEDEVA PHARMA, LTD.~E3277GA~5~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0664E~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~7E91672~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0104794	11/17/1997	OH	66.0	66		F	11/12/1997	rash-itching, swollen eyes, swollen gland in neck;rash-raised welts-entire body rash lasted 3 days;APAP PM helped;									Y	10/24/1997	10/24/1997	0	NONE	OTH	PVT	Vaseretic;Estrogen sulfate 1.25;PPD by Connaught lot# 245411 given 29OCT97;	NONE	high BP, allergy PCN	unk~ ()~~~In patient		1						1	Face oedema; Lymphadenopathy; Pruritus; Rash; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E200667KA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104796	11/17/1997	CA	44.0	44		F	11/10/1997	8NOV approx 330AM started feeling nauseous;late morning diarrhea & upset stomach w/fever;did not take temp;9NOV h/a, body aches & upset stomach;no diarrhea;10NOV still h/a & clammy;									N	11/06/1997	11/08/1997	2	NONE	PUB	PVT	Claritin;Biiaxin;	sinus infect 2wk prev	allergic rhinitis	NONE~ ()~~~In patient		1						1	Chills; Diarrhoea; Dyspepsia; Headache; Myalgia; Nausea; Pyrexia	FLU3~PFIZER\WYETH~4978189~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104799	11/17/1997	MA	39.0	39		F	11/12/1997	21OCT pt stated noc of inj felt so bad had to go to bed;pt feb;next AM felt fine;17-21OCt devel rash w/vesicle around site;pt itchy, painful had some drug;area around site remained warm & hard;seen by MD 21OCT;				Y					Y	10/16/1997	10/16/1997	0	NONE	PUB	UNK	NONE	NONE		NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Malaise; Pruritus; Pyrexia; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4978210~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104800	11/17/1997	NY				F	10/13/1997	pt c/o onset of SOB & throat tightness 10min p/vax given;no hives or wheeze noted;									Y	10/13/1997	10/13/1997	0	NONE	OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Dyspnoea; Laryngospasm	FLU3~CONNAUGHT LABORATORIES~7F81854~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104803	11/17/1997	MO	73.0	72		F	11/04/1997	states felt feverish achy muscles, h/a;laid around & didn't feel lke doing work;did not take temp;sx complicated because of back (low)problems & allergies preexisting;states felt better on 1NOV97;recovered;									Y	10/16/1997	10/17/1997	1	NONE	PVT	PUB	Loradine;Lithium;Risperdal	low back pain	allergies (eyes), depression, hypothrodisa;	NOEN~ ()~~~In patient	MO97050	1						1	Headache; Malaise; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81816~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104804	11/17/1997	VA	45.0	45		F	11/03/1997	pt recv vax 27OCT97 & returned to clinic 29OCT97 for swelling of lt upper arm;area was about 2cm wide extending about 10cms in a crest from anterior to posterior upper arm;swelling greater yesterday;applied ice reduced the swelling;									Y	10/27/1997	10/28/1997	1	NONE	PUB	UNK	TB inject given;	NONE	allergies codeine, strawberries	~ ()~~~In patient	VA97054	1						1	Injection site oedema; Injection site reaction	FLU3~CONNAUGHT LABORATORIES~7F81748~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0906E~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0104805	11/17/1997	OK	61.0	61		F	10/30/1997	22OCT began having diff breathing, pvt MD out of office went to hosp ER given 4 or 5 shots, 2 breathing tx & 02;also recv CXR & EGG;given rx for prelone syrup;				Y					Y	10/13/1997	10/22/1997	9	CXR & EEG	PUB	PUB	Atrovent inhaler;Inphrine;Tagmet	NONE	allergies, emphysema, asthma;	NONE~ ()~~~In patient	OK9737	1						1	Dyspnoea; Hypoxia	FLU3~MEDEVA PHARMA, LTD.~E3277GA4~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0104806	11/17/1997	OK	71.0	71		F	10/31/1997	pt recv vax 30OCT97 PM devel a knot @ inj site & today has erythema mid anterior upper rt arm below inj site;today site is sl warm to touch & has some erythema;instructed to apply warm moist compresses for 5-10min;4x per day;									Y	10/30/1997	10/30/1997	0	NA	PUB	PUB	NA	NA	NA	NONE~ ()~~~In patient	OK9739	1						1	Injection site hypersensitivity; Injection site mass; Rash; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3277GA~5~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0906E~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0104808	11/17/1997	OH	37.0	37		F	11/04/1997	pt recv vax 650Am 29OCT97 @ work site started itching @ inj site approx 10AM arm felt hot by evening;felt hot & sweaty like had fever but did not check temp;redness/warmth in upper arm kept inc;MD felt lump in it;				Y					Y	10/29/1997	10/30/1997	1	NA	PUB	PVT	NONE	NONE	sinus problems @ time;allergy to bee sting;	NA~ ()~~~In patient		1						1	Hyperhidrosis; Injection site hypersensitivity; Injection site mass; Pruritus; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81917~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0104809	11/17/1997	OH	40.0	40		F	11/03/1997	pt recv vax 615AM 29OCT97 @ work site;10PM noticed soreness in arm when rolled over;next AM had area size of silver dollar that was red warm & hurt to touch;saw 3rd shift Rn & went to work;930PM 30OCT97 was called to med;had infect;				Y					Y	10/29/1997	10/30/1997	1	NA	PUB	PVT	Estrogen	NONE	asthma	NA~ ()~~~In patient		1						1	Hyperaesthesia; Infection; Myalgia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81917~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0104810	11/17/1997	OH	41.0	41		F	11/13/1997	pt recv vax 29OCT97 approx 215PM;30OCT97 rubbed arm & noted it was red & swollen saw MD 31OCT97;MD office checked temp-no fever, no drainage from site;dx as local rxn;instructed to use ice packs 20min out of every 3hr;take APAP;				Y					Y	10/29/1997	10/30/1997	1	NA	PUB	PVT	Verapamil	NA	allergic to sulfa, red food coloring;HTN	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site reaction	FLU3~CONNAUGHT LABORATORIES~7F81860~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0104811	11/17/1997	FL	48.0	48		F	11/05/1997	running nose w/in 5min;burning throat w/in 5min;burning arm shot area;inj site turned red immed & lasted four days;size larger than silver dollar;									Y	10/23/1997	10/23/1997	0	NA	OTH	OTH	Ventolin, atrovent, intal, tilodel, synthroid, estrogen		multiply chemical sensitive, asthma, RADS, allergy	pt exp extreme swelling arm/red @ 45yr old w/pneumonia;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104812	11/17/1997	IL	50.0	50		M	11/03/1997	31OCT97 430PM while driving car became very dizzy, & disoriented pulled over building & the road were moving for 10-15min;c/o tingling in lt leg from the foot to the knee lasted 10-15min;felt disoriented & apprehensive until 11PM 1NOV97;									Y	10/31/1997	10/31/1997	0		PUB	PUB	NONE	NONE	PCN	~ ()~~~In patient	IL97101	1						1	Anxiety; Confusional state; Dizziness; Paraesthesia; Vertigo	FLU3~CONNAUGHT LABORATORIES~7F81840~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104813	11/17/1997	FL	40.0	40		F	10/30/1997	dizzy-hot-sinking feeling plugged ears-red skin;				Y					Y	10/30/1997	10/30/1997	0	NONE	PVT	OTH	Aldactone	NONE	NONE	NONE~ ()~~~In patient	IL97100	1						1	Anxiety; Dizziness; Ear disorder; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81755~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0104816	11/17/1997	MS	43.0	43		F	10/30/1997	inj site rt arm painful w/swelling surrounded by 5-6cm area of induration;where inj was given 23OCT97;pt seen by MD & instructed to make appointment w/pvt MD for tx;				Y					U	10/23/1997	10/25/1997	2	NONE	PUB	OTH	NONE	NONE	NONE	~ ()~~~In patient	MS97046	1						1	Injection site mass; Injection site oedema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~0770E~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~CONNAUGHT LABORATORIES~7F91694~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0104818	11/17/1997	WA	43.0	43		M	11/13/1997	urticaria;									Y	10/16/1993	10/23/1997	1468	NONE	PVT	PVT	Dilantin, HCTZ, Zocor		tuberosis sclerosis	~ ()~~~In patient		1						1	Urticaria	FLU3~PFIZER\WYETH~4978197~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104819	11/17/1997	WA	67.0	67		F	11/13/1997	lips felt puffy;dizziness;									Y	10/27/1997	10/27/1997	0		PVT	PVT	Glynase;Glucophage	NONE	NONE	~ ()~~~In patient		1						1	Dizziness; Face oedema	FLU3~CONNAUGHT LABORATORIES~7F81819~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104820	11/17/1997	MS	34.0	34		F	11/12/1997	eyes red & swollen, watery & burning;visit to ER, MD placed on pred x 5 days, atarax & zantac;				Y					Y	10/31/1997	11/01/1997	1		PVT	OTH	NONE	NONE	PCN, sulfa drugs, wisk detergent	NONE~ ()~~~In patient		1						1	Conjunctivitis; Face oedema; Lacrimal disorder; Pain	FLU3~PFIZER\WYETH~4978273~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104339	11/18/1997	CA	36.0	36		F	10/23/1997	obstetrical pt @ clinic was given flu shot per county protocol on 15OCt97 during OB visit;pt had a fetal demise @ hosp;pt feels this may have been caused by the flu shot;										10/15/1997	10/18/1997	3	autopsy & micro on placenta done @ hosp	PUB	PUB	prenatal vitamins	NONE	NKA, None known conditions	NONE~ ()~~~In patient	CA970093	1						2	Foetal disorder; Foetal disorder	FLU3~CONNAUGHT LABORATORIES~7F81841~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7F81841~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0104833	11/18/1997	KS	45.0	45		F	11/05/1997	onset of severe body ache;extremely severe diarrhea, hypovolemia & syncope;tachycardia & low BP, weakness;unsteady when first get up but able to walk normally;post vaccine synd;				Y	Y	9	Y		Y	10/12/1997	10/14/1997	2	CBC, stool specimens, urine specimens	OTH	OTH	Noroxin;Prozac q day;TB test positive result 16SEP97;	Noroxin in AM of 12OCT97 bladder infect	NONE	NONE~ ()~~~In patient		1						1	Asthenia; Coordination abnormal; Diarrhoea; Myalgia; Myasthenic syndrome; Post vaccination syndrome; Syncope; Tachycardia	FLU3~CONNAUGHT LABORATORIES~7F81894~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0104834	11/18/1997	MD	58.0	58		F	11/05/1997	fever 100.2, rash rt upper arm;h/a, chills;treated w/APAP 2 x 24hr;improved 5NOV97;redness @ site persists;									U	11/03/1997	11/04/1997	1	NONE	PUB	PUB	NONE	NONE	sinusitis, breast cancer surgery	NONE~ ()~~~In patient	MD97018	1						1	Chills; Headache; Injection site hypersensitivity; Pyrexia; Rash	FLU3~MEDEVA PHARMA, LTD.~E20067KF~2~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~441216~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0104845	11/18/1997	CA	19.0	19		F	10/27/1997	lt arm peripheral sensory neuropathy >90% resolved by 10 days post vax & cont to improve;				Y					Y	10/23/1997	10/24/1997	1	NA	OTH	PVT	Nordette	NONE	NONE	NA~ ()~~~In patient		1						1	Neuropathy	FLU3~PFIZER\WYETH~4978146~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104851	11/18/1997	AZ	35.0	35		F	11/03/1997	pt recv vax last wednesday & wednesday was fine, Thursday was fine but Friday morning body aches, bad h/a, legs hurt, just flu sx;									Y	10/29/1997	10/31/1997	2		OTH	OTH		NONE		~ ()~~~In patient		1						1	Headache; Influenza; Myalgia; Pain	FLU3~PFIZER\WYETH~4978159~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104856	11/18/1997	AZ	37.0	37		F	10/27/1997	low grade fever;										10/16/1997				OTH	OTH		NA		~ ()~~~In patient		1						1	Pyrexia	FLU3~PFIZER\WYETH~4978142~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104858	11/18/1997	CA	35.0	35		F	11/10/1997	redness & swelling 3 1/2 x 3 @ inj site;									Y	11/07/1997	11/07/1997	0	NONE	PVT	PVT		NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~7F81818~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104253	11/19/1997	MD	71.0	71		M	11/19/1997	pt recv vax 28OCT97 & felt unwell the day before but was feeling fine on the day of inj;to MD w/SOB, weakness, pallor, cyanosis & could hardly walk;tx w/02;swelling from forearm to hand;t96.8	Y	11/04/1997							N	10/28/1997	11/04/1997	7	NONE	PUB	PUB	NONE		6NOV97 hx of alcohol & tobacco use;	~ ()~~~In patient	MPI97830	1						3	Asthenia; Cyanosis; Dyspnoea; Hypothermia; Oedema peripheral; Pallor; Asthenia; Cyanosis; Dyspnoea; Hypothermia; Oedema peripheral; Pallor; Apnoea; Asthenia; Cyanosis; Dyspnoea; Hypokinesia; Hypoxia; Malaise; Oedema peripheral; Asthenia; Cyanosis; Dyspnoea; Hypoxia; Oedema peripheral; Pallor	FLU3~MEDEVA PHARMA, LTD.~E20017HC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~441214~1~IM~RA~PNEUMO (PNU-IMUNE)~1|FLU3~MEDEVA PHARMA, LTD.~E20017HC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~PFIZER\WYETH~441247~1~IM~RA~PNEUMO (PNU-IMUNE)~2|FLU3~MEDEVA PHARMA, LTD.~E20017HC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~3|PPV~PFIZER\WYETH~441249998~UNK~IM~~PNEUMO (PNU-IMUNE)~3|FLU3~MEDEVA PHARMA, LTD.~E20017HC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~4|PPV~PFIZER\WYETH~441247~1~IM~RA~PNEUMO (PNU-IMUNE)~4	USA	Results in Death	Influenza
0104866	11/19/1997	SC	64.0	64		F	10/31/1997	pt recv vax 7NOV96 & 8NOV96 pt exp v;13NOV96 pt exp muscle pain in legs, back, shoulder, hands & fingers;exp numbness & tingling in fingertips only;pt dx w/severe CTS;diff performing daily activities;tested for GBS;								Y	N	11/07/1996	11/08/1996	1	nerve conduction test indicated severe carpal tunnel synd testing for rheumatoid arthritis was negative;	PUB	OTH	Dyazide, premarin, hysterectomy 1980;poss allergy to APAP #3;	NONE	borderline HTN;	~ ()~~~In patient	10150970130000	1						1	Guillain-Barre syndrome; Hypokinesia; Myalgia; Paraesthesia; Tenosynovitis; Vomiting	FLU3~PARKE-DAVIS~~1~SC A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Disabling	Influenza
0104867	11/19/1997	MO	38.0	37		M	11/02/1997	Guillain-Barre synd;					Y			Y		10/27/1997	10/27/1997	0	28OCT97 EMG;spinal tap;nl sed rate, ANA, CPR, RA;CBC, chem 23, B12 level;	UNK	UNK	Pneumovax;			~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~7F81755~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0104868	11/19/1997	CA	76.0	76		M	11/13/1997	w/in 24hr of vax pt devel weakness (gen), myalgia & confusion;pt was adm to hosp;pt seen by neurologist;CSR, LP, head CT & several MRI reported;pt had lt wandering eye dx ptosis;pt ? encephalitis vs acute demyelination;poss MS or GBS;				Y	Y	25	Y		Y	09/28/1997	09/30/1997	2		UNK	UNK				~ ()~~~In patient	CO7749	1						1	Asthenia; Confusional state; Encephalitis; Eyelid ptosis; Guillain-Barre syndrome; Multiple sclerosis; Myalgia; Neuropathy	FLU3~CONNAUGHT LABORATORIES~7F81840~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0104883	11/19/1997	NY	30.0			F	11/18/1997	pt recv vax & exp sleepiness & severe h/a some time p/vax;reporter suspected an encephalopathy;									N	10/01/1997			blood wor & EB vrius test results were all WNL;noted that there was no significant change in EB virus;no MRI;	OTH	OTH		immunization against influenza	8mo earlies pt exp fatigue, immune studies were undertaken;found to be recovering from Epstein Barr virus infect;	~ ()~~~In patient	MPI97828	1						1	Headache; Somnolence	FLU3~MEDEVA PHARMA, LTD.~E33576B~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104884	11/19/1997	ND	35.0	34		F	11/12/1997	achiness on lt side, redness & swelling;lt shoulder pain w/area of erythema about 4x8cm in lt deltoid area;no regional adenopathy or signs of cellulitis;warm to touch & gen tenderness in the area;oropharyngeal exam negative;				Y					Y	10/22/1997	10/24/1997	2		PUB	PUB	Imipramine	intermittent cough since July	NKA as of 22OCT97	NONE~ ()~~~In patient	MN97048	1						1	Injection site hypersensitivity; Injection site pain; Myalgia; Oedema; Vasodilatation	FLU3~PFIZER\WYETH~4978149~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~435958~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0104886	11/19/1997	MT	56.0	56		F	11/12/1997	woke up w/several knotted & sore sites in muscles of rt shoulder-blade area (shot in rt arm);some shooting pain in scalp stopped p/2 days but knotted muscles painful;acupuncture/massage/heat helped;felt fatigue, dizziness w/tilt of head;				Y					N	10/10/1997	10/11/1997	1		PUB	PUB	estrogen/progestin	NONE	NONE	~ ()~~~In patient	MT98016	1						1	Asthenia; Dizziness; Hypertonia; Myalgia; Pain	FLU3~PFIZER\WYETH~4978167~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104887	11/19/1997	MA	54.0	53		M	11/10/1997	about 23OCT97 to 29OCT97 apprehensive, nervous, impending doom no temp, did have h/a, bed very early, sl BP elevation, dizzy when working out, no energy-no appetite;									Y	10/21/1997	10/23/1997	2		PUB	PUB		NONE	NONE	~ ()~~~In patient	MA9729	1						1	Anorexia; Anxiety; Asthenia; Dizziness; Headache; Hypertension; Nervousness; Somnolence	FLU3~CONNAUGHT LABORATORIES~7F81793~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104888	11/19/1997	DC	72.0			F	11/17/1997	5 days post vax pt devel terrible sore throat-bad cold w/sl temp, chills, feeling sick x 10 day devel into hard cold-a lot of coughing w/mucus;														UNK	UNK				~ ()~~~In patient		1						1	Cough; Malaise; Pharyngitis; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104891	11/19/1997	TX	10.0	10		M		hives 48hr p/vax given;									Y	11/03/1997	11/05/1997	2	NONE	PVT	PVT	NONE	NONE	NKDA/NONE	~ ()~~~In patient		1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81852~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104897	11/19/1997	UT	40.0	40		F	11/05/1997	pt states felt fine a/vax;later chills, fever, swelling of lt deltoid, couldn't move arm;feeling of being unwell-burped up egg taste;reported sx to hlth dept 5NOV97;states knows this was a rxn to flu shot;									Y	10/31/1997	10/31/1997	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	UT970635	1						1	Chills; Eructation; Hypokinesia; Injection site oedema; Malaise; Pyrexia	FLU3~PFIZER\WYETH~4978146~6~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0906E~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0104955	11/19/1997	WA	47.0	47		F	10/22/1997	pt recv vax 16OCT97 1040AM states approx 130PM same day @ home passed out & had trouble moving;daughter called 911-pt was discharged same day on 17OCT97 states feels fine, just tired;				Y					Y	10/16/1997	10/16/1997	0	NONE	PUB	PUB	NONE	NONE	allergy to codeine	NONE~ ()~~~In patient	WA971404	1						1	Asthenia; Hypokinesia; Syncope	FLU3~PFIZER\WYETH~4978174~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104956	11/19/1997	WA	8.0	8		M	10/21/1997	blistering, itchy rash @ inj site, dizziness, h/a, almost collapsed w/in 10min of vax;									Y	10/17/1997	10/17/1997	0	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	WA971405	1						1	Dizziness; Headache; Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~4978197~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104958	11/19/1997	CA	47.0	47		F	11/10/1997	full flu sx for about 12hr fever, chills, all over body aching (intense);									Y	11/03/1997	11/03/1997	0	NA	PUB	OTH	ASA col;	NA	crohn's disease	NA~ ()~~~In patient		1						1	Chills; Influenza; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104960	11/19/1997	CA	40.0	40		F	11/12/1997	pounding h/a, unsettled stomach (butterfly's), tired, body aches (no soreness @ inj site), & medicine taste in mouth;took 3 regular strength APAP;									U	11/12/1997	11/12/1997	0	NONE	PUB	PVT	NONE	NONE	sulfa drugs	NONE~ ()~~~In patient		1						1	Asthenia; Dysgeusia; Dyspepsia; Headache; Myalgia	FLU3~PFIZER\WYETH~4978189~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104961	11/19/1997	MT	57.0	57		M	11/11/1997	cellulitis following inj;									Y	10/21/1997	10/22/1997	1	NONE	PVT	UNK	Synthroid;Darvocet;Estrogen;	vertigo, ?	fibro myalgia, hypothyroidism,bronchiolitis;	NONE~ ()~~~In patient		1						1	Cellulitis	FLU3~PFIZER\WYETH~4978159~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~444067~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0104962	11/19/1997	OH	67.0	67		F	10/23/1997	fever, chills, myalgia, malaise, tx w/APAP & fluids, bed rest;get a thermometer & monitor temp									Y	10/20/1997	10/23/1997	3	NONE	PVT	PVT	pepcid, proventil,, anacin, humulin insulin, rezulin, estylenol, xanax	NONE	IDDM, obesity, osteorthritis knee, AAD, canddiasis	unk~ ()~~~In patient		1						1	Chills; Malaise; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81885~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104963	11/19/1997	VA	80.0	79		F	11/13/1997	lt arm ached for a couple of days;it was very sensitive & sl swollen on upper arm;came down w/severe depression on 26OCT97;broke out w/hives on evening of 26OCT97;itchy;									Y	10/24/1997	10/26/1997	2		PUB	UNK		NONE	allergy to PCN	NONE~ ()~~~In patient		1						1	Depression; Myalgia; Oedema peripheral; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104966	11/19/1997	CO	49.0	49		F	11/11/1997	@ time of inj pt stated felt pressure;pt stated had pain in lt arm;pt stated pain radiated from shoulder to elbow of the lt arm;									U	10/29/1997	11/06/1997	8		PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site pain; Pain	FLU3~PFIZER\WYETH~4978165~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104968	11/19/1997	NY	9.0	9		F	11/12/1997	round red warm area @ site of vax 3 1/2cm wide & 4cm long;another round red itchy area mid chest 2 1/2cm long & 3 1/2cm wide;									Y	10/17/1997	10/24/1997	7	NONE	PVT	PVT	Intal;Albuterol	resolving asthma episode	reactive airway disease/asthma	pt exp possible irritability from DTP as infant~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81861~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0807E~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0104969	11/19/1997	OH	78.0	78		F	11/12/1997	no fever;erythema of rt upper arm, nausea, felt fuzzy in head 1st 24hr;									Y	11/12/1997			NONE	PVT	UNK		NONE		~ ()~~~In patient		1						1	Dizziness; Nausea; Rash	FLU3~CONNAUGHT LABORATORIES~7F818931~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~444067~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0104970	11/19/1997	CA	61.0	61		M	11/10/1997	24hr p/vax onset of fever, malaise, anorexia, rhinorrhea, cough, sore throat;sx for 2 days, gradual resolution over 1wk;final resolution of cough & weakness 2wk p/onset;mild flu immed p/vax;									Y	10/26/1997	10/27/1997	1	NONE	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Anorexia; Asthenia; Cough; Influenza; Malaise; Pharyngitis; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104972	11/19/1997	IN	55.0	54		F		red area around shot area-approx 3-4 diameter;cellulitis;									Y	10/07/1997	10/09/1997	2		OTH	OTH			NONE	~ ()~~~In patient		1						1	Cellulitis; Injection site hypersensitivity	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0104973	11/19/1997	AR	62.0	62		M	11/12/1997	arm swelled, warm & erythematous;mild constitutional sx including chills & myalgia;				Y					Y	11/07/1997	11/07/1997	0	NONE	PVT	PVT	Inderal, dynacirc	NONE	hiatal hernias, high BP	~ ()~~~In patient		1						1	Chills; Myalgia; Oedema peripheral; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4978154~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~442520~1~SC~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0104976	11/19/1997	CO	41.0	41		F	11/05/1997	24hr p/vax had a swollen lt lymph node under lt axilla;took APAP;uncomfortable to lay on lt side;node was size of an egg;very painful;pt has recv flu vax past 6yr;									Y	11/01/1997	11/02/1997	1	NOEN	PUB	PVT	NONE	NONE	allergy to duck embryo-rabies inj yrs ago	~ ()~~~In patient		1						1	Lymphadenopathy; Neck pain; Skin nodule	FLU3~PFIZER\WYETH~4978165~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104978	11/19/1997	MO	3.0	3		M	11/10/1997	4NOV97 rt shoulder to elbow was red w/hives, swollen & hard all around;rt arm only shot recv in that one-very itchy;no temp;pt active & happy using arm well;arm still hot, swollen & red but less;arm rough where shot given;									Y	11/03/1997	11/04/1997	1	NONE	PVT	PVT	albuterol intal;flovent;atrovent via nebulizer;	NONE	asthma;hx of ER reflux birth;	NONE~ ()~~~In patient		1						1	Dry skin; Injection site hypersensitivity; Injection site mass; Injection site oedema; Oedema peripheral; Pruritus	FLU3~PFIZER\WYETH~5VIA8~3~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104979	11/19/1997	CO	58.0	57		F	11/03/1997	upper arm itched was red & had raised welt like area the day p/& for approx a week after;									Y	10/15/1997	10/16/1997	1		OTH	PUB	Prinzide	NOEN	ovarian cancer in remission, high blood pressure, herniated disk	NONE~ ()~~~In patient		1						1	Pruritus; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81895~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104980	11/19/1997	NY	59.0	59		M	11/13/1997	left 6th nerve palsy				Y					N	10/04/1997	11/08/1997	35	neurology referral	PVT	PVT	glyburide;Lisinopril	type ii diabetes HTN	1994 exposed to TB treated w/isoniacin & peradoxin	~ ()~~~In patient		1						1	Neuropathy; Paralysis	FLU3~CONNAUGHT LABORATORIES~7F81788~1~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0104981	11/19/1997	CA	31.0	31		F	11/13/1997	7NOV97 had itching on neck area only;approx 6PM noticed itching & saw dark red itching patches on neck & antecubital fossa;areas were warm to touch like a sunburn;still has light rash;									Y	11/06/1997	11/07/1997	1	NONE	PVT	PVT	NONE	NONE	NKDA	pt exp same as above @ age 31 w/hep B dose 1;~ ()~~~In patient		1						1	Pruritus; Rash; Skin discolouration; Vasodilatation	FLU3~PFIZER\WYETH~4978202~3~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0104982	11/19/1997	NY	71.0	71		M	11/13/1997	acute onset of lt third nerve palsy, onset approx 22OCT97;				Y					N	10/15/1997	10/23/1997	8		PVT	PVT	enteric coated ASA senvastatin;atenolol	cornary artery disease post antioplasty	remote 1981 meningococcal meningitis 1982 acute pericarditis	NONE~ ()~~~In patient		1						1	Neuropathy; Paralysis	FLU3~CONNAUGHT LABORATORIES~7F81788~5~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0104984	11/19/1997	WY	72.0	72		F	11/12/1997	pt recv vax & felt sharp sting on opposite (under) side of lt arm just above the elbow;itched profusely;original stinging sensation was followed by scattered pink prick sensation over a period of an hr or more;turn red & feverish & itched;									Y	10/22/1997	10/26/1997	4	NONE	OTH	OTH	pt recv allergy shot 17 & 25OCT97	NONE	allergies	NONE~ ()~~~In patient		1						1	Pain; Paraesthesia; Pruritus; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81895~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0104988	11/19/1997	NC	64.0	64		F	11/10/1997	pt recv vax 7NOV97 & evening of 8NOV97 lt arm sore, red & hot had knot on arm bigger than a silver dollar;hard applied ice;on Sunday had a few red spots on lt arm;applied heat;10NOV97 denies fever, hardness lt arm gone away;									Y	11/07/1997	11/08/1997	1	NONE	PUB	PUB	Tardol;EStrogen, Premarin	NONE	arthritis, seasonal allergies worse i spring than fall scolioses	NONE~ ()~~~In patient	NC97112	1						1	Myalgia; Rash; Skin nodule; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81895~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~435963~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0104994	11/19/1997	PA	39.0	39		F	10/24/1997	pt recv vax 22OCT97 & 24OCT97 c/o itching & swelling lt arm;hives distal to inj site;				Y						10/22/1997	10/24/1997	2		UNK	UNK				~ ()~~~In patient		1						1	Oedema peripheral; Pruritus; Urticaria; Oedema; Rash; Tachycardia; Urticaria	FLU3~PFIZER\WYETH~4978207~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4978207~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0104876	11/20/1997	MI	67.0	67		M	11/04/1997	pt recv vax in AM 9OCT97 & around 4AM awakened w/sweating & nausea, 1hr fever, muscle aching in arm;consulted pmd & adm to hosp;d/c 11OCT;					Y	1			Y	10/09/1997	10/10/1997	1	CXR, blood work, stress test E thalium, EKG r/o cardiac disease/all tests WNL	PUB	PUB		NONE	PCN/HTN-hytrin	NONE~ ()~~~In patient	MI97133	1						1	Hyperhidrosis; Myalgia; Nausea; Pyrexia	FLU3~PFIZER\WYETH~4978296~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0105042	11/20/1997	MI	73.0	73		F	11/14/1997	pulsing pain in both shoulders which has interfered w/work, recreation & sleep;persisted for 3wk;got rxn for darvocet-N;still taking naprosyn;									N	10/07/1997	10/07/1997	0	NONE	PUB	PUB	NONE	NONE	allergy PCN	NONE~ ()~~~In patient	MI97144	1						1	Pain	FLU3~PFIZER\WYETH~4978197~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0795E~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0105043	11/20/1997	MI	74.0	74		F	11/04/1997	pt recv vax 29OCT97 & devel fever of 100.8 on 1NOV97 & Sunday & Monday 103.5;body aches on Saturday & Sun then chills, fever, h/a, cough;saw MD 3NOV97;CXR neg;urine negative;BP OR blood fine x/for elevated blood count;bacterial infect;weak				Y					U	10/29/1997	11/01/1997	3	unk	PUB	PUB	Collan, premarin	NONE	HTN on meds;	~ ()~~~In patient	MI97134	1						1	Asthenia; Chills; Cough; Headache; Infection; Laboratory test abnormal; Pyrexia	FLU3~PFIZER\WYETH~4978296~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105044	11/20/1997	MI	65.0	65		F	10/21/1997	pt recv vax 17OCT97 & devel pain & swelling of pneumo vax area which also got warm;swelling progressed to elbow & below & stayed warm on 17OCt & 18OCT;pt still has discomfort;inflammation;weak;				Y					Y	10/17/1997	10/17/1997	0		PUB	PUB	Corgard-BP med;Divretic 7 K+-premarin	NONE	High BP	~ ()~~~In patient	MI97130	1						1	Injection site inflammation; Injection site oedema; Injection site pain; Oedema peripheral; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4978296~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~935958~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0105047	11/20/1997	PA	62.0	62		M	11/10/1997	c/o fever & aches 6 days p/flu vax administered;									Y	10/10/1997	10/16/1997	6	NA	OTH	PVT	unk	NONE	unk	~ ()~~~In patient		1						1	Myalgia; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E20037KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0105048	11/20/1997	AL	19.0	18		F	11/06/1997	c/o rash on legs, grass & back w/itching approx 3-4hr p/inj;swelling noted in hands;saw MD 4NOV97 & given med for itching & swelling;no better returned to MD 5NOV & given pred;				Y					Y	11/03/1997	11/03/1997	0		OTH	OTH		stuffy nose	NONE	~ ()~~~In patient	AL9732	1						1	Oedema peripheral; Pruritus; Rash	FLU3~MEDEVA PHARMA, LTD.~3257FA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0105050	11/20/1997	MT	54.0	54		M	11/12/1997	soreness to deltoid area through current date of 14NOV97;									U	10/22/1997	10/25/1997	3		PUB	PVT	Ketoprofin PRN	NONE	allergy to erythromycin	NONE~ ()~~~In patient		1						1	Myalgia	FLU3~PFIZER\WYETH~4978189~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105076	11/23/1997	MD	48.0	47		F	11/17/1997	returned to clinic 1 1/2hr p/vax c/o scattered itching & hives;+ tenderness warmth & swelling @ site of inj;pt took DPH @ onset of sx;									Y	11/03/1997	11/03/1997	0	NONE	OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4978185~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105038	11/24/1997	MD	60.0	60		F	11/07/1997	suspected GBS;2-3 days p/vax pt began exp numbness in arms & legs which then progressed over entire body including tongue & mouth;also had bifrontal h/a & pain which radiated up & down spine & legs;epigastric soreness;adm to ICU;					Y				U	10/10/1997	10/12/1997	2		PVT	PVT				~ ()~~~In patient	MD97014	1						1	Back pain; Dyspepsia; Guillain-Barre syndrome; Headache; Pain; Paraesthesia; Paraesthesia oral	FLU3~PFIZER\WYETH~4978153~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0105039	11/24/1997	CA	59.0	59		F	11/14/1997	tingling of hands & feet 31OCT progressed to reflexia ascending paresthesias, weakness;seen by neurologist readmitted to hosp 3NOV;5 days of IV IG;starting to improve still hosp as of 14NOV;dx GBS:numbness in fingers & toes;pt had back pain			Y	Y	Y				U	10/22/1997	10/31/1997	9		OTH	PVT	Premarin, Provera, Tinormin, Prinival, Trilasc	no acute illness	HTN, post menopause;digestive problems;	NONE~ ()~~~In patient		1						1	Asthenia; Back pain; Guillain-Barre syndrome; Hyporeflexia; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~7F81898~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0105057	11/24/1997	LA	67.0	66		F	11/20/1997	immed burning pain rt deltoid;devel swelling, erythema, & itching w/in 1hr;				Y					N	11/19/1997	11/19/1997	0	NONE	PUB	PUB	Reserpine;Nitrostat;lasix;daypro	NONE	HTN/rheumatoid arthritis	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81931~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~448173~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0105060	11/24/1997	OH	60.0	60		F	11/10/1997	<5min p/vax given flare 1/2 wheal, 2 below inj site-itching @ site;several hr later rt arm +swelling above elbow twice nl size w/serous seepage from swelling;sl tingling & numbness;pt did not see MD;									Y	10/21/1997	10/21/1997	0		PVT	PVT	Premarin	NONE	allergic to erythromycin (nausea/emesis) & flagyl	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Oedema peripheral; Paraesthesia; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81884~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~440741~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0105061	11/24/1997	NY	27.0	27		F	11/18/1997	cold, clammy, pale, nausea, shivering, rigidity-unaware of surroundings;feet elevated-epi given pt responded;									Y	10/29/1997	10/29/1997	0	NONE	UNK	OTH	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Chills; Hyperhidrosis; Hypertonia; Nausea; Pallor; Personality disorder; Tremor	FLU3~PFIZER\WYETH~4978188~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105062	11/24/1997	MI	68.0	68		F	11/18/1997	24OCT approx 12noon pt c/o painful rt arm w/sl redness, feet tired, droopy, had runny nose;exp cough, yellow sputum, c/o arm tender to touch;inc pain w/moving;local irritation from shot, pain & sore to touch;				Y						10/24/1997	10/24/1997	0		PUB	PVT	NONE	denied	PCN & sulfa (1981 states dx w/?MS & had optic neuritis);	denied~ ()~~~In patient	MI97152	1						1	Asthenia; Cough; Influenza; Myalgia; Pain; Productive cough; Rhinitis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81754~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105064	11/24/1997	OH	30.0	29		F	10/20/1997	about 36hr p/vax pt exp itching of feet & lower legs;subsided spontaneously @ around 2AM on 17OCT97 10PM again exp itching of feet & ankles then noticed hives on feet, ankles & back;phone ER instructed to take DPH;									Y	10/15/1997	10/16/1997	1	NONE	PUB	UNK	Depo provera	NONE	NONE	NONE~ ()~~~In patient	OH97079	1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81788~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105066	11/24/1997	MI	52.0	51		F	11/06/1997	w/in 1/hr nose was cold;felt weak & tired;5hr later exp inability to breath;taken to ER;blood 02 was very low;10NOV lt arm remains red, sore, hard & size of small apple;heart skipping beat;heartburn;nervous response;arrhythmia;				Y					Y	11/05/1997	11/05/1997	0	blood checked for 02 lung scan WNL	PVT	UNK	Estrogen patch		fibromyalgia, severe osteoporosis, reynauds synd, Degenerative disc disease, tachycardia	~ ()~~~In patient		1						1	Apnoea; Arrhythmia; Asthenia; Dyspepsia; Hypoxia; Injection site mass; Nervousness; Oedema peripheral	FLU3~PFIZER\WYETH~4978197~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~444067~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0105067	11/24/1997	VA	49.0	49		F	11/14/1997	red patch w/in 24hr, warm to touch, discomfort w/a bruise;									Y	11/08/1997	11/09/1997	1		PUB	PUB	allergy shots	NONE	dust mites	~ ()~~~In patient	VA97057	1						1	Ecchymosis; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4978169~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105068	11/24/1997	VA	6.0	6		F	11/14/1997	6NOV97 c/o soreness, sl erythematous;afternoon 7NOV97 c/o severe itching @ inj site-1 pimple noted;w/in 24hr area completely covered w/pimple like bumps;circular area 3 out from inj site covered w/numerous bumps w/itching;									Y	11/05/1997	11/07/1997	2	NONE	PUB	UNK		NONE	NONE	~ ()~~~In patient	VA97056	1						1	Injection site hypersensitivity; Pain; Pruritus; Rash	FLU3~PFIZER\WYETH~4978169~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105070	11/24/1997	OH	67.0	66		F	11/07/1997	pt recv vax & 1NOV97 felt yucky & queasy took pepto bismol;also noticed itching & feelings as if skin was dry;itching inc;4NOV97 about 7-8PM cont itching, hives noticed on legs;5NOV97 cont itching;to see MD 6NOV97;				Y					U	10/30/1997	11/01/1997	2		PUB	PUB	topical antifungal on toenail on 12JAN97;prodearz;pepto bismol	NONE	NONE	~ ()~~~In patient	OH97084	1						1	Dry skin; Malaise; Nausea; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81917~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0994E~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0105071	11/24/1997	OH	13.0	13		M	11/05/1997	pt fainted on way home immediate nausea & then vomited;lethargic 7 sleepy for several hr;did go to basketball practice 8PM ok by 10PM;no problems 4NOV97 or 5NOV97;									Y	11/03/1997	11/03/1997	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	OH97085	1						1	Somnolence; Syncope; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81917~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105075	11/24/1997	MT	62.0	62		F	11/12/1997	urticaria, generalized;had lumpy areas devel in areas where pt had heparin SC p/surgery;				Y					U	11/11/1997	11/11/1997	0	NONE	MIL	PVT		had surgery on 29OCT97		~ ()~~~In patient		1						1	Urticaria	FLU3~PFIZER\WYETH~4978151~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105079	11/24/1997	NJ	43.0	42		F	11/18/1997	lt upper extremity radiculopathy pain going from shoulder down to fingertips;				Y						10/05/1997	10/23/1997	18	MRI of spin & EMG C-spine x-ray mild DJD C6-7	OTH	PUB	tx w/anaprox & percocet & pepcid	NONE	NKDA;MAY96 partial gastric outlet obstr	~ ()~~~In patient		1						1	Arthropathy; Neuropathy; Pain	FLU3~CONNAUGHT LABORATORIES~7F8187~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105080	11/24/1997	NJ	35.0	35		F	11/12/1997	pt recv vax 6NOV97 approx 730PM waited @ hlth dept approx 20min p/vax;went home & noticed hives on stomach;called hlth dept RN told to call 911 immed;approx 845PM;began to notice hives on back & arms, lips began to swell;				Y					Y	11/06/1997	11/06/1997	0		PUB	PUB	NONE	NONE	age 19, (16 yrs ago) ASA;age 21 APAP, anaphylaxis;	~ ()~~~In patient	NJ9744	1						1	Face oedema; Urticaria	FLU3~PFIZER\WYETH~4978202~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105081	11/24/1997	MT	39.0	38		M	11/14/1997	30OCT97 5:30 pt noted numbness/tingling/pain in lt great toe-spread to foot & ankle;progressed to rt foot & ankle;move to lt hand-to forearm then rt hand;3 days later burning pain in lt face  & soreness on rt side of face;				Y						10/22/1997	10/30/1997	8	blood CBC etc, neuroapthy & myopathy panels negative;MIR of brain negative findings;	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Pain; Paraesthesia	FLU3~PFIZER\WYETH~4978189~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105086	11/24/1997	AZ	53.0	53		F	10/22/1997	8OCT97 noticed sore upon wakening, no elevation in temp;9OCT97 aroused 11AM body appeared to be sunburned;temp @ 12:30 100.7;took APAP;T102.2;T102;joints hurting behind knee, wrist lip & eye swollen;all body deeper red;dx micro-hives;				Y					Y	10/07/1997	10/08/1997	1		OTH	PVT	Altenolol;Premarin;Vitamins	NONE	HTN;cervical CA 1975;	~ ()~~~In patient	AZ9736	1						1	Arthralgia; Face oedema; Myalgia; Osteoarthritis; Pyrexia; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81753~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105087	11/24/1997	AZ	42.0	42		M	10/28/1997	diarrhea started 24OCT97 1155PM;mild fever 101-102 until 27OCT97;									Y	10/24/1997	10/24/1997	0		PUB	PVT	NONE		allergies environment	~ ()~~~In patient	AZ9735	1						1	Diarrhoea; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E3257FA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0105088	11/24/1997	CA	64.0	64		F	11/08/1997	w/in 12hr noted itchy, red rash onset on chest then spread to back then to arms over next few days;pt achy w/congestion, myalgias, cough;devel local induration @ shot site w/in 24-36hr as well;T101-102 oral w/h/a;rash seen diffuse maculopap									Y	10/11/1997	10/11/1997	0	NONE	OTH	OTH	Pred;Asulfadine	rheumatoid arthritis	NKDA;on defects;rheumatoid arthritis;dyslipidermia;glaucoma;	~ ()~~~In patient		1						1	Cough; Injection site hypersensitivity; Injection site mass; Myalgia; Pyrexia; Rash; Rash maculo-papular; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0105093	11/24/1997	NJ	39.0	39		F	10/31/1997	flat red rash on back, stomach, arms, chest w/itching;									Y	10/30/1997	10/30/1997	0		PUB	PUB	Zoloft;Wellbutrin	sore throat/cold	pt had a rash from ATB;	unk~ ()~~~In patient	NJ9743	1						1	Pruritus; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~7F81916~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0994E~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0105095	11/24/1997	NJ	83.0	82		M	11/13/1997	2wk p/vax rash appeared on chest & torso;light pink & tingles;pt encouraged to visit MD;MD prescribed cream & did not feel rash was d/t flu shot;										10/16/1997	10/30/1997	14	NONE	PUB	PUB	Prinosel	NONE		~ ()~~~In patient	NJ9742	1						1	Paraesthesia; Rash	FLU3~CONNAUGHT LABORATORIES~7F81800~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105096	11/24/1997	CA	46.0	46		F	11/04/1997	red rash noted under both arms 31OCT97 in early AM;symmetrical in design;over next 24hr rash spread to chest & abd;DPH taken w/hydrocortisone;cream applied;rash spread w/in 48hr to upper thighs;itching;dx systemic allerg rxn;				Y					Y	10/31/1997	10/31/1997	0	NONE	PVT	PVT	Ziac	NONE	NONE	NONE~ ()~~~In patient		1						1	Hypersensitivity; Pruritus; Rash	FLU3~PFIZER\WYETH~4978200~4~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105099	11/24/1997	NC	22.0	21		F	11/14/1997	approx 2 1/2hr p/vax pt started shaking BP 144/90, HR 103;states just don't feel right;denies itching or resp diff;few min later whelps noted on neck, c/o feeling hot clammy & itching & feeling flushed;given DPH & pred;				Y					Y	10/06/1997	10/06/1997	0	RA pulse ox 96%	PVT	PVT		NONE		~ ()~~~In patient		1						1	Hyperhidrosis; Hypertension; Malaise; Pruritus; Tachycardia; Tremor; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4978186~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105102	11/24/1997	MS	18.0	18		F	11/04/1997	fever;rash on stomach & chest;itching of head & arm pits bilat;				Y					Y	11/04/1997	11/04/1997	0		PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MO97054	1						1	Pruritus; Pyrexia; Rash	FLU3~MEDEVA PHARMA, LTD.~E20037HA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0105105	11/24/1997	MI	68.0	68		F	11/17/1997	pt recv vax & devel h/a, flushed, red face;lt upper arm was swollen & warm to touch, stomach distress;next morning pt exp sore throat, earaches, chills, sneezing, muscle aches, pain & swelling in upper lt arm & coughing spasms;lack of sleep									Y	10/14/1997	10/14/1997	0		PVT	OTH			PCN	pt exp rxn flu vax in forties dose 1~ ()~~~In patient		1						1	Dyspepsia; Ear pain; Insomnia; Myalgia; Pharyngitis; Pyrexia; Rhinitis; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0105106	11/24/1997	MA	42.0	42		F	11/12/1997	pt recv vax & w//in 5min of shot arm very sore;by noc couldn't move it, lift it or touch;had a fever of 100 1/2 on Thursday (the next day) my arm was very sore w/red blotches on it;still had a fever;by evening had a big red line going down				Y					Y	11/05/1997	11/05/1997	0	NONE	PUB	UNK		NONE	type one diabetes	~ ()~~~In patient	MA9726	1						1	Hypoaesthesia; Hypokinesia; Myalgia; Pyrexia; Rash; Skin striae	FLU3~CONNAUGHT LABORATORIES~7F81793~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0993F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0105107	11/24/1997	MA	38.0	38		F	11/12/1997	local rxn;swelling, movement of arm limited, feverish @ shot site;pt mom states pt had both flu & pneumovax same day;									Y	11/07/1997	11/07/1997	0		PUB	PUB		NONE		~ ()~~~In patient	MA9725	1						1	Hypokinesia; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0993E~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0105108	11/24/1997	OK	74.0	74		F	10/27/1997	aching generalized 21OCT97 p/vax;nausea x 3 days;drainage sinus productive;temp did not take temp, diarrhea;									Y	10/21/1997	10/21/1997	0	NA	PUB	PUB	Etidronate	NONE	osteoporosis	NONE~ ()~~~In patient	OK9740	1						1	Diarrhoea; Myalgia; Nausea; Pyrexia; Rhinitis; Sinusitis	FLUX~UNKNOWN MANUFACTURER~E3277GA~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0105126	11/24/1997	CA				M		got sick right away, lost weight, was almost paralyzed;			Y	Y					Y	10/11/1996				OTH	PVT	?	?	?	?~ ()~~~In patient		1						1	Malaise; Paralysis; Weight decreased	FLU3~CONNAUGHT LABORATORIES~00676P~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0104253	11/25/1997	MD	71.0	71		M	11/07/1997	pt recv vax 28OCT97 & that day devel swelling of the lt arm from forearm to hand;4NOV (7 days post vax) presented to MD w/SOB, weakness, cyanosis & pallor;refused diagnostic lab work & went home;died @ home 4NOV;	Y	11/04/1997		Y					N	10/28/1997	10/28/1997	0		PUB	PUB	NONE	NONE	hx of alcohol, tobacco use	~ ()~~~In patient	897314001L	1						4	Asthenia; Cyanosis; Dyspnoea; Hypothermia; Oedema peripheral; Pallor; Asthenia; Cyanosis; Dyspnoea; Hypothermia; Oedema peripheral; Pallor; Apnoea; Asthenia; Cyanosis; Dyspnoea; Hypokinesia; Hypoxia; Malaise; Oedema peripheral; Asthenia; Cyanosis; Dyspnoea; Hypoxia; Oedema peripheral; Pallor	FLU3~MEDEVA PHARMA, LTD.~E20017HC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~441214~1~IM~RA~PNEUMO (PNU-IMUNE)~1|FLU3~MEDEVA PHARMA, LTD.~E20017HC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~PFIZER\WYETH~441247~1~IM~RA~PNEUMO (PNU-IMUNE)~2|FLU3~MEDEVA PHARMA, LTD.~E20017HC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~3|PPV~PFIZER\WYETH~441249998~UNK~IM~~PNEUMO (PNU-IMUNE)~3|FLU3~MEDEVA PHARMA, LTD.~E20017HC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~4|PPV~PFIZER\WYETH~441247~1~IM~RA~PNEUMO (PNU-IMUNE)~4	USA	Results in Death	Influenza
0105111	11/25/1997	MI	87.0	86		M	11/19/1997	cellulitis rt elbow from rt deltoid pneumovax;arthrocentesis of elbow;WBC 30,600;RBC 150;numerous PMN's no bacteria;no fever;no chills;				Y	Y	3			Y	11/04/1997	11/07/1997	3	arthrocentesis of elbow; WBC 30600;RBC 150, numerous PMNs, no bacteria; no fever or chills	PUB	PUB	unk	NONE	NONE	~ ()~~~In patient	MI97145	1						1	Cellulitis; Laboratory test abnormal; Leukocytosis; Red blood cell abnormality	FLU3~PFIZER\WYETH~4978174~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0585D~1~SC~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0105113	11/25/1997	FL				M	11/03/1997	pt alleges devel GBS & suffered an aggravation of a pre-existing disease or condition;hosp for 3mo;month which was spent in ICU;22OCT96 has not recovered balance & strength;severe psychological problems which has drastically curtailed work					Y	90		Y	N	11/25/1993				OTH	OTH	unk	unk	this plaintiff may have had a prev episode of GBS	~ ()~~~In patient	897308014L	1						1	Asthenia; Condition aggravated; Coordination abnormal; Guillain-Barre syndrome; Personality disorder	FLU3~MEDEVA PHARMA, LTD.~E2253HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0105118	11/25/1997	IA				U	10/31/1997	infant's mom recv vax 4 days prior to conception;pt was born w/anencephaly & died @ birth;					Y									OTH	OTH	unk	NONE		~ ()~~~In patient	897308008L	1						1	Foetal disorder; Neonatal disorder	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0105119	11/25/1997	FL	65.0	65		F	11/04/1997	2 days p/vax pt devel cellulitis @ pnu imune23 site;pt was hosp treated w/IV ATB & d/c from the hosp on 28OCT;					Y	5			Y	10/21/1997	10/23/1997	2		PUB	OTH	NONE	NONE		~ ()~~~In patient	897310014L	1						1	Cellulitis; Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~441213~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0105125	11/25/1997	NY	100.0	100		F	11/17/1997	pt recv vax 27OCT97 & w/in a few hr T103.3, chills, shaking, inc temp cont for 2 days on 29OCT:T106.3 color pale blowing resp exp green sputum transferred to hosp;	Y	10/30/1997							N	10/27/1997	10/27/1997	0		UNK	UNK		NONE	no allergies-had degenerative osteoarthritis cerebrovascular insufficiency	~ ()~~~In patient		1						1	Chills; Dyspnoea; Pallor; Productive cough; Pyrexia; Tremor; Dyspnoea; Pallor; Productive cough; Pyrexia; Tremor	FLU3~CONNAUGHT LABORATORIES~7F81916~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7F81916~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0105127	11/25/1997	AL	33.0	33		M	11/19/1997	2wk p/vax pt devel severe h/a located @ base of skull behind lt eye;tx w/steroids & muscle relaxer for 1 wk;h/a reoccurred w/lt side hemiparesis;p/extensive tests MD dx transverse myelitis;				Y	Y	5			U	10/23/1997	11/08/1997	16	CAT scan negative;LP (MS profile-negative);MRI scan poss;	OTH	PVT	Monopril	UNK	mild HTN	~ ()~~~In patient		1						1	Ear disorder; Eye pain; Headache; Hemiplegia; Hypertonia; Myelitis; Pruritus	FLU3~PFIZER\WYETH~4978142~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0105132	11/25/1997	MA	53.0	53		F	11/13/1997	swelling, redness, pain in rt arm;MD rx cleocin, DPH, APAP for pain;				Y					Y	11/05/1997	11/05/1997	0		PUB	PUB	yes	NONE	NONE	~ ()~~~In patient	MA9728	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81793~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0993E~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0105133	11/25/1997	MA	66.0	66		F	11/19/1997	T100.3 to 104 & dec 99.4 x 3-4 days;severe redness of face from elbow to hands, from chin to chest-elbow & neck subsided p/2 days;face stayed fine red for 5-6 days;BP elevated;pt felt scalding hot;puffy look;									Y	10/25/1997	10/25/1997	0		PUB	PUB	Pentasa, mult vit, premarin, trazodone, lotril, naprosyn, cortizone;		crohn's disease	~ ()~~~In patient	MA9735	1						1	Hypertension; Oedema; Pain; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81793~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105134	11/25/1997	KY	64.0	63		F		rotator cuff, tendinitis, shot was given to high on shoulder, extreme pain, couldn't raise arm;									N	10/24/1997	10/24/1997	0		PUB	PUB				~ ()~~~In patient	KY970042	1						1	Hypokinesia; Pain; Tendon disorder	FLU3~PFIZER\WYETH~4978145~5~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~441216~1~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0105137	11/25/1997	NY	72.0	72		M	10/24/1997	pt recv vax 16OCT97 & removed bandaid 17OCT noticed 3/4W scratch & redness;18OCT put a new bandaid w/triple ATB;21OCT noticed gob of pus;also noted 22OCt & 23OCT;24OCT to MD no pus noted shot given in shoulder per pt felt achy 1-2 days;				Y					Y	10/16/1997	10/17/1997	1		PUB	PUB	vevacor;ASA;BP meds calan, verepamil, prinivil, tetracyclarie, darvacet skin condition	NONE	HTN, hypercholesterol	~ ()~~~In patient	NY97050	1						1	Infection; Injection site hypersensitivity; Myalgia	FLU3~CONNAUGHT LABORATORIES~7F81832~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105141	11/25/1997	NH	27.0	27		F	11/17/1997	inj site red & warm;site hard & painful;11OCT97 seen in walk-in care; dx allerg rxn vs infect;ATB given;				Y					Y	10/09/1997	10/11/1997	2		PVT	OTH	?	NONE	NONE	~ ()~~~In patient		1						1	Hypersensitivity; Infection; Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81800~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105142	11/25/1997	SD	26.0	26		F	11/15/1997	erythema mult treated by pvt MD w/corticosteroid, antihistamine;pt recv vax & c/o skin rash & seen by MD who told pt had hives;pt has geographic erythematous & purpuric lesions over palms, distal forearms & rt ankle;									Y	11/03/1997	11/03/1997	0	NONE	OTH	PVT	Zyban do overall-Birth control	NONE	allergy shots for 10yr-none last 2yr	NONE~ ()~~~In patient		1						1	Erythema multiforme; Pruritus; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81741~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105143	11/25/1997	FL	48.0	48		F	11/14/1997	skin w/bruising 1 1/2 diameter-blue yellow pink red skin around inj site;									Y	11/06/1997	11/07/1997	1	NA	PVT	UNK		unk	HTN-ASA therapy every other day;	~ ()~~~In patient		1						1	Ecchymosis; Injection site hypersensitivity	FLU3~PFIZER\WYETH~497841~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105146	11/25/1997	MN	44.0	44		F	11/17/1997	became tired & achy next day;could hardly get through work 2 days later;by 24 missed work & stayed in bed for a week;scary;so very tired & achy;took lots of pain reliever for aches;seen by MD;back to work on 31OCT97;				Y					Y	10/20/1997	10/22/1997	2		OTH	OTH	NONE	NONE	NONE	unk~ ()~~~In patient		1						1	Anxiety; Asthenia; Malaise; Myalgia	FLU3~CONNAUGHT LABORATORIES~7F81771~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105153	11/25/1997	CO	54.0	54		F	11/19/1997	4PM started feeling nauseated, whole body felt crawling sensation;lt arm swelling red, hot, sore 7cm diameter x 12hr;									Y	11/12/1997	11/12/1997	0	NA	PVT	OTH	Synthroid	NONE	molds, pollens, dust, sulfa drug	pt exp swelling, pain, nausea @ ?30yr old w/dT;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Nausea; Paraesthesia; Vasodilatation	FLU3~PFIZER\WYETH~4978272~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105155	11/25/1997	NY	73.0	73		F	11/19/1997	evening of vax pt exp body aches, fever (degree unk), malaise, chills;no sx next morning;									Y	11/05/1997	11/05/1997	0	NONE	PVT	PVT	NONE	NONE	unk	~ ()~~~In patient		1						1	Chills; Malaise; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81895~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105157	11/25/1997	NH	46.0	46		M	10/23/1997	pt recv vax p/noon of 9OCT97 later that PM pt noticed stiff neck-progressed over weekend to lt side of face, head, neck and lt arm numbness;no paralysis, no vision change;seen in office 14OCT97;									Y	10/09/1997	10/09/1997	0	CBC done WNL; sed rate WNL	PVT	UNK		NONE		~ ()~~~In patient	NH97025	1						1	Facial palsy; Nuchal rigidity; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~7F81854~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105158	11/25/1997	NY	72.0	72		F	11/03/1997	31OCT watery diarrhea @ 8hr;1NOV muscle aches, flu-like sx;2NOV cough, stuffy nose; no fever;									Y	10/30/1997	10/31/1997	1	NONE	PUB	PUB	anti-hypertensive, synthroid	NONE	HTN, hypothyroid	~ ()~~~In patient	NY97055	1						1	Cough; Diarrhoea; Influenza; Myalgia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~7F8157~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~445638~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0105160	11/25/1997	NY	34.0	34		F	10/24/1997	pt recv vax c/o stinging p/inj;returned to RN about 45min later c/o pain rt side on neck/shoulder & numb like feeling in rt arm & hand;rt had cool to touch & weaker rt grasp then lt hand;rt inj site appears ok;				Y					Y	10/24/1997	10/24/1997	0		PUB	UNK	Lasiz	lupus/fibromyalgia	lupus/fibromyalgia	~ ()~~~In patient	NY97053	1						1	Chills; Myasthenic syndrome; Neck pain; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4978169~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105165	11/25/1997	OH	46.0	46		M		h/a-sore throat, aching body-fever;coughing-congested;									Y	10/29/1997				OTH	PVT				~ ()~~~In patient		1						1	Cough; Headache; Myalgia; Pharyngitis; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~7F81742~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105169	11/25/1997	OR	37.0			M	11/10/1997	abd cramping approx 15-30min p/vax;flu like sx x 1wk, next wk tired, lethargic feelings;local stiff, swell, sore-heavy feeling;bilat arm;									Y	10/17/1997	10/17/1997	0		PUB	UNK		unk		~ ()~~~In patient		1						1	Abdominal pain; Asthenia; Hypotonia; Influenza; Injection site oedema; Injection site pain; Myasthenic syndrome; Somnolence	FLUX~UNKNOWN MANUFACTURER~497872~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0845D~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0105171	11/25/1997	NY	37.0	37		M	11/21/1997	paralysis of cranial nerve IX, X, XI, XII on lt;tx w/steroids & IV gamma globulin;					Y				Y	10/15/1997	10/20/1997	5	MRI negative	OTH	OTH	NONE	NONE	nONE	~ ()~~~In patient		1						1	Neuropathy; Paralysis	FLU3~CONNAUGHT LABORATORIES~7F81771~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0105173	11/25/1997	NM	33.0	33		F	11/13/1997	low grad sinus infect- bactrim dx by PMD;fluid in rt ear;not watching diet good;stated sore next day post flu vax not too bad post 4 days flu shot gradually got worse;woke up in morning worse but would get better w/hot shower;cant lift arm				Y					U	10/28/1997	11/02/1997	5	NONE	PUB	PUB	ventolin inhaler;palmocourt inhaler, cerdrenma	denied but poss infect	asthma, hypoglycemia, allergy ASA, solumedrol, augmentin	NONE~ ()~~~In patient	NM97037	1						1	Anorexia; Ear disorder; Hypokinesia; Infection; Myalgia	FLUX~UNKNOWN MANUFACTURER~4978165~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0105174	11/25/1997	MI	55.0	54		F	11/13/1997	extensive redness & itching @ inj site & also neck & chest area;lasting 45-60min in duration									Y	10/20/1997	10/20/1997	0		OTH	PVT		NONE		~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~7F81834~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105175	11/25/1997	MI	56.0	56		F	11/13/1997	severe redness & swelling involving outer lt arm from shoulder to elbow;									Y	10/20/1997	10/21/1997	1		OTH	PVT				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81834~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105176	11/25/1997	UT	69.0	69		F	11/18/1997	w/in 24hr of vax the site of inj was swollen to size of baseball;pt c/o soreness, redness @ site;no fever noted;48hr p/vax pt went to the MD & was dx w/cellulitis & put on z-pack ATB;				Y					Y	10/29/1997	10/30/1997	1	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	UT971843	1						1	Cellulitis; Injection site mass; Injection site oedema	FLU3~PFIZER\WYETH~4978167~3~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~3~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0105177	11/25/1997	TX	68.0	68		M	10/28/1997	pt recv vax 22OCT97 & pt stated next day large erythematous area from inj site down to elbow;presents 24OCT97 w/erythema 11x20 cm on lt deltoid & elbow region;no streaking;cool packs advised;no other special tx required;									Y	10/22/1997	10/24/1997	2	NONE	PVT	PVT	Hytrin, Cardizem	NONE	NKA HTN-arthritis-PVD-prostatic hypertrophy	~ ()~~~In patient		1						1	Injection site hypersensitivity; Rash	FLU3~PFIZER\WYETH~4978160~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~435957~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0105178	11/25/1997	TX	68.0	67		F	10/28/1997	pt recv vax 22OCT97 & pt stated next day large erythematous area @ the inj site;presents 24OCT97 w/erythema 5x6cm @ the inj site;no streaking;cool packs advised;									Y	10/22/1997	10/24/1997	2	NONE	PVT	PVT	Premarin, Fosamax, synthroid, procardia	NONE	xylocaine, osteoporosis, hypothyroidism, ASCVD	~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~4978160~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105179	11/25/1997	MA	21.0	21		F	11/05/1997	2.5 hr p/vax pt retching, flushed face, blurred vision, HR 120/regular;radial pulse 20 irregular;no rxn @ site of vax;seen by MD airway & lungs clear;HR dec;during 45min visit devel local erythema @ inj site;edema of hands;				Y					Y	11/05/1997	11/05/1997	0	02 sat 98%;EKG nl;	OTH	PUB		h/a on arising;	shell fish allergy, poison ivy & ivory soap allergies;	~ ()~~~In patient		1						1	Amblyopia; Bradycardia; Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Vasodilatation; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81793~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105180	11/25/1997	MA	38.0	38		F	11/10/1997	pt recv vax 103 fever 2AM-7PM p/vax;									Y	11/05/1997	11/06/1997	1	NONE	OTH	PUB				pt exp fever @ 37yr old w/flu vax;~ ()~~~In patient		1						1	Pyrexia	FLU3~CONNAUGHT LABORATORIES~7781793~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105182	11/25/1997	NY	62.0	62		F	11/19/1997	2nd day p/vax exp sore throat, cough, fatigue, malaise, fever, episodes of diaphoresis during noc, nasal congestion, green phlegm;fatigue & malaise still persisted for several weeks;									Y	10/21/1997	10/23/1997	2		PVT	PVT	unk	NONE	unk	~ ()~~~In patient		1						1	Asthenia; Cough; Hyperhidrosis; Malaise; Pharyngitis; Productive cough; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~7F81895~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105184	11/25/1997	MI	33.0	33		F	11/10/1997	31OCT97 pt exp pain in lt arm & shoulder;pain cont & blister appeared on arm away from inj site;PA did state inj should have been given further back on arm in a more fatty part of muscle;				Y					Y	10/29/1997	10/31/1997	2	NA	OTH	PVT	APAP,Ibuprophen	NONE	asthma	~ ()~~~In patient		1						1	Dermatitis bullous; Pain	FLU3~CONNAUGHT LABORATORIES~7F81894~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105185	11/25/1997	PA	32.0	32		F		p/vax first day weak, shaky, 2nd day hives then since then 10 days recurrent chills, sweats, arthralgias, presyncope feelings;still sx today;									N	11/07/1997	11/07/1997	0	CBC, chem profile 24, ESR are WNL x/for sl elevated Fe;	OTH	PUB		unk	insomnia from TMP/SMX	~ ()~~~In patient		1						1	Arthralgia; Asthenia; Blood iron increased; Chills; Dizziness; Hyperhidrosis; Tremor; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81894~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105186	11/25/1997	NY	52.0	52		F	11/18/1997	bilat knee pain, stiffness & heaviness of lower legs all c/o -no fever, no edema, erythema or inc warmth;lt patella tendonitis noted on exam;									U	11/13/1997	11/15/1997	2		PUB	OTH	Norvasc	NONE		~ ()~~~In patient		1						1	Hypertonia; Myasthenic syndrome; Pain; Tendon disorder	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105188	11/25/1997	ND	18.0	18		M	11/14/1997	onset of varicella rash 21 days after vax (>50 lesions)-no fever, no severe systemic rxn;group home resident isolated from other kids @ onset;									U	10/22/1997	11/11/1997	20		OTH	OTH	PPD recv 22OCT97;pt recv pneumovax AUG97;Erythromycin;Phenobarb;CaCO3, Centrum, bactofen, diazepam, atrovent, albuterol, dulcolax,benzamycin, vanceril	NONE	static encephalopathy, sz disorder, mental retardation	~ ()~~~In patient		1						1	Dermatitis bullous	FLU3~PFIZER\WYETH~4978174~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|MMR~MERCK & CO. INC.~0109E~2~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0964E~1~~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0103991	11/28/1997	MD	56.0	55		F	11/12/1997	baseball sized swelling to elbow w/redness & itching;this occurred @ 5PM on 17OCT97;18OCT97 AM pt had chills, lethargic, low grade fever & diarrhea;persisted until 12OCT97;									Y	10/17/1997	10/17/1997	0	NONE	PVT	UNK	Toprol;	NONE	NONE	pt exp large swollen arm w/flu vax;~ ()~~~In patient		1						2	Chills; Nausea; Oedema peripheral; Pyrexia; Skin nodule; Somnolence; Vasodilatation; Chills; Diarrhoea; Oedema peripheral; Pruritus; Pyrexia; Somnolence; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~MEDEVA PHARMA, LTD.~E3367HC~5~SC A~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0105194	11/28/1997	NY	3.0	3		M	11/21/1997	severely delayed child became lethargic;48hr p/vax brought to ED, expired during CT scan to evaluate shunt status;	Y	11/09/1997							N	11/06/1997	11/09/1997	3		PVT	OTH		NONE	hydroencephaly, shunted hydrocephalis, cerebral palsy			1						1	Somnolence; Somnolence	FLU3~PFIZER\WYETH~4978218~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4978218~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Results in Death	Influenza
0105195	11/28/1997	OH	78.0	77		F	11/10/1997	pains in lower abd & both legs, red rash, burning on urination, temp?, fever & chills;hosp on 2NOV97 dc 4NOV97;					Y	2			N	10/15/1997	10/27/1997	12		PUB	PUB		NONE	HBP	~ ()~~~In patient	OH97088	1						1	Abdominal pain; Dysuria; Pyrexia; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81917~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0994E~1~~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0105196	11/28/1997	MA	71.0	71		F	11/19/1997	devel h/a & vomiting w/in 3hr p/vax;taken by amb to ER;had high fever adm overnoc tx w/IV fluids etc;				Y	Y	1			Y	10/22/1997	10/22/1997	0		PUB	PUB	NONE	NONE	allergic to PCN, codeine sulfa;	pt devel h/a & vomiting w/flu shot 12hr ago;~ ()~~~In patient	MA9731	1						1	Dehydration; Headache; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81793~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0105197	11/28/1997	KY	67.0	67		M	11/18/1997	pt was found slumped in chair early morning of 17NOV97;they think pt had a heart attack according to wife;	Y	11/17/1997								10/23/1997	11/17/1997	25		PUB	PUB				~ ()~~~In patient		1						1	Cardiovascular disorder; Stupor	FLU3~PFIZER\WYETH~4978145~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0105210	11/28/1997	SC	59.0	59		F	10/20/1997	pt began to c/o feeling bad approx 20min post inj;pt said chest hurt & was nauseated;pt began to cry;pt took nitro tab that had w/her;EMS present @ hlth fair & responded w/in 1-2min;EKG showed some cardiac problems & inc BP;					Y	3			Y	10/18/1997	10/18/1997	0		OTH	PUB			tetanus, cardiac problems	pt exp rxn @ 58yr old w/tetanus;~ ()~~~In patient	SC97069	1						1	Agitation; Cardiovascular disorder; Chest pain; Condition aggravated; Hypertension; Malaise; Nausea	FLU3~MEDEVA PHARMA, LTD.~E3287GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0105211	11/28/1997	CA	65.0	65		U	11/11/1997	red rash-swelling lt leg sat 12OCT;body sensitivity lt side;Sat 12OCT & Monday 14OCT went to MD given cream for leg;no better during week;went to another MD 31OCT;severe cold diff breathing 28OCT;took 10 days to reduce most sx;				Y					Y	10/23/1997	10/24/1997	1		PUB	PUB		NONE	high BP;had quad by pass 19OCT95	~ ()~~~In patient	CA980012	1						1	Dyspnoea; Hypoaesthesia; Oedema peripheral; Rash; Rhinitis	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105215	11/28/1997	CA	46.0	46		F	11/21/1997	pt has swelling @ the site of the flu inj about 1 1/4 on 18NOV97 & 2 x 3 on 19NOV97;swelling was red & hot;advised that pt could use DPH;									U	11/17/1997	11/18/1997	1		PVT	PVT			pt says had some radation 2yr ago but not last yr	pt exp swelling @ 44yr old w/flu vax;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81841~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105218	11/28/1997	IL	76.0	76		F	10/21/1997	24hr p/vax pt felt tired; 3 days later started w/neck aches & pruritus;wrist & arm swelling up to elbow;lt arm achiness yesterday;h/a started on 20OCT97;18OCT97 stiffness of all joints;swelling cont @ lt wrist & thumb;				Y						10/15/1997	10/18/1997	3	NONE	PUB	UNK	Ibuprofen;Inderal;Carden;Ooeal	NONE	neuropathy, allerg to sulfa, angina;	NONE~ ()~~~In patient	IL97105	1						1	Arthropathy; Asthenia; Headache; Neck pain; Oedema peripheral; Pruritus	FLU3~MEDEVA PHARMA, LTD.~E3327GA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0105224	11/28/1997	NC	84.0	84		F	11/06/1997	pt recv vax 4NOV97 noticed itching all over & 2hr palms of hand & bottom of feet red;approx 2hr p/that broke out all over red raised rash;c/o diarrhea, n/vx1, tongue swelling & diff breathing;				Y					U	11/04/1997	11/04/1997	0		PUB	PUB	Daypro	NONE	arthritis	NA~ ()~~~In patient	NC97114	1						1	Diarrhoea; Dyspnoea; Pruritus; Tongue oedema; Urticaria; Vasodilatation; Vomiting	FLU3~PFIZER\WYETH~4978273~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105225	11/28/1997	NJ	34.0	34		F	11/24/1997	pt c/o h/a late on 18NOV97, took a dose of generic h/a med & went to bed;awakened @ 1PM w/hives over back, stomach;neck & arms w/intense itching, swelling of lips & tightness in chest;				Y					Y	11/17/1997	11/19/1997	2	NA	PVT	PVT	generic h/a med	NONE	unk	unk~ ()~~~In patient		1						1	Chest pain; Face oedema; Headache; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81854~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105237	11/28/1997	OR	72.0	72		F		shot was painful pt reported shoulder kept hurting more until it became painful to use arm;pt reports it is still paining									N	10/02/1997	10/02/1997	0		UNK	UNK				~ ()~~~In patient		1						1	Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0105238	11/28/1997	CA	56.0			U		exp intense neck, back & bilat shoulder pain lasting about 5 days;				Y					Y					PVT	PVT	NONE	NONE	benign prostatic hypertrophy	NONE~ ()~~~In patient		1						1	Back pain; Neck pain; Pain	FLU3~CONNAUGHT LABORATORIES~7F81930~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105240	11/28/1997	OH	17.0	17		F	11/20/1997	pt recv vax 7NOV97 230PM stating was covered w/hives on torso, arms, legs & foot;states has been taking DPH per MD;18NOV97 to clinic;PMD states all hives have cleared up & denies any resp problems;									Y	11/07/1997	11/10/1997	3	NA	PUB	PVT	NONE	NONE	pollen allergies	NA~ ()~~~In patient		1						1	Urticaria	FLU3~PFIZER\WYETH~4978192~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105245	11/28/1997	SC	73.0	73		F	10/22/1997	230PM 21OCT97 & 5PM pt had knot about size large grape, rubbed size inc to 2 wide 3 long, small amount redness about 1 thick, pain only on touch, T100;muscle underarm touchy;touch tender;									Y	10/21/1997	10/21/1997	0		PUB	PUB	Ultram oxybutyrim;Lorazepam	NONE	allergic to klonopin	~ ()~~~In patient	SC97070	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Myalgia; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E3287GA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0906E~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0105246	11/28/1997	SC	61.0	61		M	10/21/1997	red area 1.5cm diameter;									Y	10/20/1997	10/21/1997	1	NA	PUB	PUB	TImolol	NONE	HTN	~ ()~~~In patient	SC97086	1						1	Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E32872GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0906E~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0105250	11/28/1997	OH	46.0	46		F	11/17/1997	awoke next day following flu vax w/severe h/a;no other sx;recv partial relief w/advil;slept most of day;									Y	10/15/1997	10/16/1997	1	NONE	PUB	OTH	NONE	NONE	hx of TMJ	~ ()~~~In patient	OH97089	1						1	Headache	FLU3~CONNAUGHT LABORATORIES~7F81788~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105258	11/28/1997	IA	58.0	58		F	11/03/1997	arm w/much discomfort shoulder to elbow-very painful on movement started following day p/vax;vax given 22OCT97 feeling better by 24OCT through 30OCT when pain started again;									U	10/22/1997	10/30/1997	8		PUB	UNK	Atenol;L-thyroxin;TD by connaught lot# 6J81325	NONE	lt mastectomy 1983;gallbladder surbery 1996;	NA~ ()~~~In patient	IA97042	1						1	Myalgia	FLU3~CONNAUGHT LABORATORIES~7F81816~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105259	11/28/1997	MA	74.0			F	11/18/1997	c/o lt arm, unable to lift arm p/recv vax that day in lt arm;denies redness or swelling @ inj site also states felt unwell next few days, no specific sx;									Y	11/01/1997	11/01/1997	0		PUB	UNK	NONE	NONE	NONE	~ ()~~~In patient	MA9730	1						1	Hypokinesia; Malaise	FLU3~CONNAUGHT LABORATORIES~7F81793~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105260	11/28/1997	MA	58.0			F	11/21/1997	immed pain @ inj site w/edema lt upper arm, redness, red raised rash appeared in AM p/a few hr c/o itching for 1 1/2wk;no SOB, diff breathing;area of redness 10cmx12cm per MD office;				Y					Y	10/16/1997	10/16/1997	0		PVT	UNK		NONE	NONE	pt got sick, red inj site w/flu vax 78 & 96;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus; Rash maculo-papular; Vasodilatation	FLU3~PFIZER\WYETH~4968142~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105266	11/28/1997	CA	50.0	50		F	10/24/1997	3PM pt c/o itching;no hives or other sx;DPH taken by pt 3:45PM;no sx;itching disappeared;pt reported on 23OCT that on 22OCT 530PM had chills & fever (fever# unk);23OCT T102 c/o achiness;24OCT97 all sx disappeared;									Y	10/22/1997	10/22/1997	0	NONE	PUB	PUB	Ogen;Premarin hormones	NONE	PCN @ age 34;	~ ()~~~In patient	CA970104	1						1	Myalgia; Pruritus; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81788~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0102893	12/01/1997	CO	45.0	45		F	11/25/1997	onset w/in min throat & ears itchy-nausea, dizzy, sensation of throat closing, weak;paramedics called;			Y	Y					Y	10/01/1997	10/01/1997	0	skin test (prick) egg-negative;	OTH	PUB	NONE	NONE	food intolerances-non IgE mediated;	NA~ ()~~~In patient		1						2	Anaphylactoid reaction; Dyspnoea; Hypotension; Hypoventilation; Laryngospasm; Pruritus; Asthenia; Dizziness; Ear disorder; Laryngospasm; Nausea; Pharyngitis; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81862~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7F81862~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening	Influenza
0105272	12/01/1997	MO	64.0	64		F	11/13/1997	c/o lt arm discomfort PM p/flu vax that AM;discomfort inc & occurs only w/movement;MD eval 11NOV97 & dx parasympathetic reflex disorder;MD does not feel this was directly from flu vax;may have been the stress that set off the problem;				Y						10/31/1997	10/31/1997	0		OTH	PUB	Amaryl, Imuran, Amantadine, Baclofen, Inderal, Paxil, Ditropan, Propulsid, Prempro, Demedex, Potassium chloride, Pericolace, Restoril, Clotinmazole, flucinonide, calcium, MOM;	MS/NIDDM/PUD	MS/NIDDM/PUD;NKA	~ ()~~~In patient	MO97055	1						1	Anxiety; Hyporeflexia; Pain	FLU3~CONNAUGHT LABORATORIES~7F81884~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105275	12/01/1997	SC	43.0	43		F	11/19/1997	excruciating back pain starting approx 11AM 2NOV97 unable to walk Sunday or Monday-returned to work 4NOV97 but lt early for home d/t tiredness from prescribed meds;muscle pain still evident 4NOV;pt had similar rxn w/lyme disease in 1995;									Y	10/31/1997	11/02/1997	2	NONE	PUB	PUB	NONE	NONE	mitral valvu prolapse	pt exp extreme flu @ 22yr old w/flu vax dose 1;~ ()~~~In patient	SC97088	1						1	Asthenia; Back pain; Hypokinesia; Myalgia	FLU3~MEDEVA PHARMA, LTD.~E3287GH~2~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1173E~1~SC~LA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~7C91583~2~~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0105279	12/01/1997	CO	41.0	41		F	11/24/1997	pt recv vax 29OCT97 & symptomatic till 17NOV97-burning, itchy rash lt arm, dorsum wrist, & shoulder, no URI sx or other illness;scattered vesicles lt lat chest wall;T4-6 dermatome distribution w/ 1 lesion;lesions wide, raised erythematous				Y					Y	10/20/1997	11/17/1997	28	NONE	OTH	OTH	?claritan & entex	?sinus syms	hayfer, childhood food allergies, chronic sinuses condition	NONE~ ()~~~In patient		1						1	Dermatitis bullous; Pain; Pruritus; Skin ulcer	FLU3~PFIZER\WYETH~4978171~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105280	12/01/1997	CO	43.0	43		M	11/18/1997	28OCT97 pt recv vax & 48hr later devel stinging rash w/vesicular eruptions on rt posterior neck rt lower jaw/inner cheek & 4cm spot on chest;5 days later saw ED for sx;on sx was chills 48-72hr p/vax;				Y						10/28/1997	10/30/1997	2	3NOV97 viral cult=varicella zoster	OTH	OTH	NONE	NONE	denies	NONE~ ()~~~In patient		1						1	Chills; Dermatitis bullous; Herpes zoster; Infection; Pain	FLU3~PFIZER\WYETH~4978171~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105281	12/01/1997	CO	59.0	59		M	11/18/1997	about 48hr p/vax noticed a rash & small blisters on lt arm inj site, upper forearm & wrist area which inc in intensity over time;seen by emp hlth 68hr later & viral cult done;pt elected to see MD				Y					Y	10/29/1997	10/31/1997	2	viral cult-varicella zoster 3NOV97	OTH	UNK		denies sx	HTN, hiatial hernia, CAD (MI 1992)	unk~ ()~~~In patient		1						1	Dermatitis bullous; Injection site hypersensitivity	FLU3~PFIZER\WYETH~4978171~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105282	12/01/1997	VA	52.0	52		F	11/17/1997	pt recv vax 10NOV97 10AM & itching of body began same day & cont through 12NOV97;no rash, no hives reported;thinks chilled for approx 1hr Tuesday PM;took DPH;woke up during noc 11NOV97 x2 w/hands asleep;swollen joints of hands, knees;									Y	11/10/1997	11/10/1997	0	NONE	UNK	PUB	Niacin;Prenovil	NONE	mold & house dust allergy;HTN	NONE~ ()~~~In patient	VA97058	1						1	Chills; Insomnia; Oedema; Osteoarthritis; Paraesthesia; Pruritus	FLU3~PFIZER\WYETH~4978169~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105283	12/01/1997	VA	32.0	32		F	11/12/1997	hives covering entire body & palms of hands;9NOV97 inj of steroids, epi, zytec;10NOV97 pred 6 day course;				Y					Y	11/07/1997	11/07/1997	0	physicians observations	OTH	UNK	Amoxicillin	strep infect dx 29OCT tx w/amoxicillin	NA	unk~ ()~~~In patient		1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0105288	12/01/1997	OR	36.0	36		F	11/25/1997	pt devel erythematous macular, papular rash on back, arms, abd, legs & buttocks 11 days p/vax;									U	10/17/1997	10/28/1997	11		PVT	PVT	no meds	NONE	NONE	~ ()~~~In patient		1						1	Rash maculo-papular	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|MMR~MERCK & CO. INC.~~UNK~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1|TD~CONNAUGHT LABORATORIES~~UNK~IM~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0105289	12/01/1997	WI	73.0	73		M	11/07/1997	purpuric rash almost confluent on legs & anterior area;Henoch schenoch purpura;									Y	10/01/1997	10/13/1997	12	PT-nl; CBC nl;	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0105290	12/01/1997	CA	8.0	8		F	11/20/1997	pt devel itching & rash over inj site of vax w/in hr of vax;itchy rash persisted 3 day rash consisted of easily blanched papules w/surrounding erythema around inj site;									Y	11/14/1997	11/15/1997	1	NONE	PVT	PVT	NONE	NONE	ADHD	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81598~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105291	12/01/1997	AZ	65.0	65		F	11/25/1997	during inj pt perceived that needle hit lt humerus bone & vax ran down along bone;devel lt rotator cuff type tendonitis w/in a wk of vax;rx relefen & xray & steroid inj;				Y					N	10/17/1997	10/24/1997	7	x-ray shoulder nl	PVT	PVT	ober, Ibuprofen	NONE	prior hx from shoulder on lt	~ ()~~~In patient		1						1	Tendon disorder	FLU3~PFIZER\WYETH~4978142~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105292	12/01/1997	MN	43.0	43		M	11/25/1997	swelling in upper arm between elbow & shoulder;hard to move arm;red, sore, warm to touch;swelled 2-3x nl size;skin taut, anything touching it hurt;saw MD 1-2wk later suggested Ibuprofen;said not to repeat;				Y					Y	10/21/1997	10/22/1997	1	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MN97049	1						1	Hypoaesthesia; Oedema peripheral; Pain; Skin disorder; Vasodilatation	FLU3~PFIZER\WYETH~4978168~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0104261	12/02/1997	CA	57.0	57		F	11/25/1997	pt recv vax 1030AM became aware of tongue swelling @ 7PM rt side of base, took two analgesic APAP & went to bed;next AM swelling gone;									Y	10/28/1997	10/28/1997	0	NA	OTH	OTH	NONE	NONE	NONE	pt arm sore w/flu vax;~ ()~~~In patient		1						2	Tongue oedema; Tongue oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~2	USA		Influenza
0105194	12/02/1997	NY	3.0	3		M	11/21/1997	pt became lethargic AM of 9NOV & was brought to ED;pt expired in CT scan during eval;	Y	11/09/1997							N	11/06/1997	11/09/1997	3		PVT	UNK			hydroencephaly;shunted hydrocephalus	~ ()~~~In patient		1						2	Somnolence; Somnolence	FLU3~PFIZER\WYETH~4978218~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4978218~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Results in Death	Influenza
0105293	12/02/1997	OR	78.0	78		F	11/24/1997	death	Y	11/13/1996							N	11/12/1996	11/12/1996	0		OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Unevaluable event	FLU3~CONNAUGHT LABORATORIES~6F71238~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0105296	12/02/1997	FL	74.0	74		M	11/24/1997	pt devel extreme weakness, Guillain Barre type sx, requiring adm to hosp 1NOV97;slow improvement w/gamma globulin administration;tx to rehab 19NOV;	Y	11/21/1997			Y	18			N	10/21/1997	11/01/1997	11	1NOV CT scan head nl;ESR 20;WBC 8.8;CSF glucose 65;protein 78;WBC 0;C&S negative;	OTH	UNK	Atenolol	HTn	NONE	~ ()~~~In patient		1						1	Asthenia; CSF test abnormal; Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~7F81894~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0105299	12/02/1997	IA	8.0			M	11/06/1997	pt recv vax 31OCT97 & w/in 24hr p/vax pt exp aggravation of asthma & devel croup;pt was hosp 1NOV97 & tx w/corticosteroid therapy;					Y				U	10/31/1997	11/01/1997	1		OTH	OTH	unk	unk	asthma	~ ()~~~In patient	897318013L	1						1	Asthma; Condition aggravated; Cough; Dyspnoea; Laryngitis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0105301	12/02/1997	MN	31.0	31		F	11/04/1997	pt recv vax & w/in approx 2-3 days devel metabolic acidosis & dec level of consciousness;pt was hosp;unspecified test have been negative;					Y	14			Y	10/28/1997	10/30/1997	2		PVT	PVT	K-DUR, Epivir, Zerit, Viracept, Prozac, Trazodone, Depakote, Risperdal, Aladactone, Cogentin	HIV infect	HIV infect ince 1990; epilepsy, obesity, anxiety, paranoid; schizophrenia	~ ()~~~In patient	897318007L	1						1	Acidosis; Hepatomegaly; Stupor	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0105303	12/02/1997	NY	65.0	65		F	11/25/1997	1-2hr p/vax site became red, swollen, rash & itching present;2 days later 1NOV97 swelling extended beyond shoulder to glands in neck;had erythromycin @ home, took med;swelling going down remained red & itchy & tender to touch;									Y	10/30/1997	10/30/1997	0		PUB	PUB	Premarin (off @ that time)		possibly bee stings	~ ()~~~In patient	NY97061	1						1	Hypoaesthesia; Injection site hypersensitivity; Injection site oedema; Lymphadenopathy; Oedema peripheral; Pain; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81856~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105307	12/02/1997	WY	54.0	54		F	10/30/1997	shortly p/vax c/o diff swallowing, chest tightness, thickness of tongue, dry mouth;BP 80/60, P92 regular pt has hx HTN, DPH given & pt put in lying position;p/5min BP 130/82, feeling better, some light headedness;P88 regular;5min later BP 1									Y	10/21/1997	10/21/1997	0		PUB	PUB		NONE	HTN	~ ()~~~In patient	WY9710	1						1	Chest pain; Condition aggravated; Dizziness; Dry mouth; Dysphagia; Hypotension; Tachycardia; Tongue oedema	FLU3~PFIZER\WYETH~4978146~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105312	12/02/1997	SC	69.0	69		M	11/06/1997	pt recv vax 4NOV97 & 5-6hr later arm started turning red, is hot to touch & is swollen, arm felt better Wednesday AM but by PM it had started swelling & was red down to below elbow;arms still swollen & warm;pt states not painful;									Y	11/04/1997	11/04/1997	0	NA	PUB	PUB	BP med	NONE	PCN	~ ()~~~In patient	SC97087	1						1	Oedema peripheral; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3287GH~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0906E~1~IM A~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0105314	12/02/1997	SC	73.0	73		F	10/20/1997	14OCT97 pt noticed redness, swelling @ site size of a saucer that evening while dressing;stated was a hard area in center;applied warm compress x 3 days;area still pink but hard area almost gone p/6th day post vax									U	10/14/1997	10/14/1997	0	NA	PUB	PUB	Tapazole 1/2 tab daily;hydrochlorothiazide;ASA daily;	NONE	NA	~ ()~~~In patient	SC97068	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~MEDEVA PHARMA, LTD.~E3287GH~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0906E~1~~LL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0105319	12/02/1997	MI	23.0	23		F	11/21/1997	pt states that on 31OCT97 had a h/a & gen achiness w/temp of 102 1-2NOV97 cont to feel tired & achy;3NOV97 vomited all day & had diarrhea;this cont through 6NOV97 when called family MD;pt remains tired 18NOV97;									N	10/30/1997	10/31/1997	1		OTH	PVT		NONE	chronic colitis, crohn's disease	~ ()~~~In patient		1						1	Asthenia; Diarrhoea; Headache; Myalgia; Pyrexia; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E3367HC~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0105322	12/02/1997	MI	55.0	55		F	11/07/1997	angioedema hives;				Y					N	10/23/1997	10/30/1997	7		PVT	PVT			hypothyroidism, hyperlipidemia	~ ()~~~In patient		1						1	Angioneurotic oedema; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81818~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105325	12/02/1997	SC	40.0	40		F	11/18/1997	local rxn of 6cm x 6cm redder area w/swelling occurred 20min p/vax & vax was given by employer as a yearly thing;				Y					Y	10/20/1997	10/20/1997	0	NONE	PVT	OTH		NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4978182~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105327	12/02/1997	OK	42.0	42		F	11/24/1997	diffuse myalgia, arthralgia, fever, chills, changes in mental status;nausea;onset of sx-12hr lasted 48hr;									Y	10/20/1997	10/20/1997	0	NONE	PVT	PVT			systemic lupus erythematosis	NONE~ ()~~~In patient		1						1	Arthralgia; Myalgia; Nausea; Personality disorder; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81895~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105328	12/02/1997	KS	54.0	54		F	11/24/1997	pt recv vax 20OCT97 3PM & by 7PM started coughing, eyes burning felt like something lodged in throat, gen aching;next day 5AM swelling noted upper eyelids & below eyes & lips;									Y	10/20/1997	10/20/1997	0	NONE	PUB	PVT	Premarin;Progesterone	NONE	allergy-sulfa	NONE~ ()~~~In patient		1						1	Cough; Eye pain; Face oedema; Laryngospasm; Myalgia	FLU3~CONNAUGHT LABORATORIES~7F81744~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105331	12/02/1997	MA	80.0	80		F	11/20/1997	chills (no fever), shakiness, nausea & a feeling of swelling or closing inside throat;									Y	11/06/1997	11/06/1997	0	NONE	OTH	PUB	Plendil;Micronase;	NONE	HTN	~ ()~~~In patient		1						1	Chills; Laryngospasm; Nausea; Tremor	FLU3~CONNAUGHT LABORATORIES~7F81793~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105334	12/03/1997	WI	76.0			M	10/29/1997	pt recv vax 27OCT97 & c/o rt arm pain w/movement, tender to touch, swollen, warm, no redness;febrile overnoc to 101.7, pain & erythema devel @ inj site w/swelling & fluid in rt bursa;dx cellulitis per infect disease specialist					Y					10/27/1997	10/27/1997	0		UNK	UNK			allergy NKDA;	~ ()~~~In patient		1						1	Cellulitis; Hypokinesia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Osteoarthritis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0105335	12/03/1997	GA	77.0	77		F	11/21/1997	flu-like sx started 24-48hr p/flu vax w/low back & thigh pain & LL Quad pain;pt came in 10OCT97;flu vax given 26SEP97;recheck 24OCT97;pt reported chills, fever, wheezing & cough;31OCT97 epigastric pain radiated to back;					Y				Y	09/26/1997	09/27/1997	1	GB & pancreatic studeis negative;	PVT	UNK				~ ()~~~In patient		1						1	Abdominal pain; Asthma; Back pain; Cough; Dyspepsia; Influenza; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81723~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0105336	12/03/1997	NY	85.0	85		F	11/28/1997	w/in 24hr of vax pt exp hearing related sx in both ears;voices are heard @ two distinct pitches @ the same time-a nl pitch & a very low pitch;marked hearing loss;inability to recognize familiar voices;singing voices sound off key;				Y				Y	N	09/16/1997	09/17/1997	1	both tests indicated significant hearing loss bilat;standard hearing test X3;BAER test brain stem auditory response test;	PVT	PVT	Synthroid once/day	NONE	hypothyroid condition	NONE~ ()~~~In patient		1						1	Deafness transitory	FLU3~CONNAUGHT LABORATORIES~7F81840~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0105338	12/03/1997	OR	64.0	64		F	12/02/1997	GBS dx 29OCT97;					Y	14			N	10/07/1997	10/29/1997	22	spinal tap	PVT	PVT		chronic pain synd w/repeated surgeries		NA~ ()~~~In patient		1						1	Back pain; Guillain-Barre syndrome	FLU3~PFIZER\WYETH~4978151~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0105341	12/03/1997	HI				U		5 adults exp local rxn @ the inj site, including redness, swelling, tenderness to touch lasting @ least 3 days p/vax;											09/25/1997			UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81819~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105342	12/03/1997	HI				U		5 adults exp local rxn @ inj site, including redness, swelling, tenderness to touch lasting @ least 3 days p/vax;											09/25/1997			UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81819~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105343	12/03/1997	HI				U		5 adults exp local rxn @ the inj site, including redness, swelling, tenderness to touch lasting @ least 3 days p/inj;											09/25/1997			UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81819~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105344	12/03/1997	HI				U		5 adults exp local rxn @ the inj site, including redness, swelling, tenderness to touch lasting @ least 3 days p/inj;											09/25/1997			UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81819~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105345	12/03/1997	HI				U		5 adults exp local rxn @ inj site, including redness, swelling, tenderness to touch lasting @ least 3 days p/inj;											09/25/1997			UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81819~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105351	12/03/1997	IL	28.0	28		F	11/12/1997	1hr p/vax pt devel 3 episodes of migraine h/a sx;sx included jagged lines in vision & no peripheral vision, & waves of numbness started in hands & going through to feet;pt has hx of migraines;									Y	11/12/1997	11/12/1997	0	NA	PUB	PVT	NONE	NONE	NKDA, denies all allergies, hx of migraines (none x 4mo);	NONE~ ()~~~In patient		1						1	Condition aggravated; Paraesthesia; Visual disturbance; Visual field defect	FLU3~CONNAUGHT LABORATORIES~7F81852~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105353	12/03/1997	IL	70.0	70		M	11/28/1997	@ time of vax pt devel knot @ site;bruise noted a few days later;									Y	11/13/1997	11/13/1997	0	NONE	PVT	PUB	Allopurinol;Glucotrol;Glucophage;Zestril;Quinine	NONE	diabetes mellitus, HTN, renal insufficiency, cardiomyopathy	~ ()~~~In patient		1						1	Ecchymosis; Injection site mass	FLU3~CONNAUGHT LABORATORIES~7F81752~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105354	12/03/1997	NY	58.0	58		F	11/25/1997	sharp pain in rt hand, pain in neck & under arm;									Y	11/18/1997	11/19/1997	1		PUB	PVT	NA			~ ()~~~In patient		1						1	Neck pain; Pain	FLU3~CONNAUGHT LABORATORIES~7F81857~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105372	12/03/1997	PA	47.0	46		F	10/29/1997	hives on rt thigh;									Y	10/27/1997	10/27/1997	0		OTH	PUB	Thyroid			~ ()~~~In patient		1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0105362	12/04/1997	IL	57.0	57		F	11/21/1997	pt semi-responsive @ hosp;currently on a ventilator;sx started approx 20OCT97 w/bronchitis type sx;med/ATB didn't help;pt collapsed upon			Y		Y				N	10/17/1997	10/20/1997	3		PUB	PUB	unk		bilat mastectomy 7yr ago	~ ()~~~In patient	IL97106	1						1	Bronchitis; Hypoxia; Stupor; Syncope	FLU3~MEDEVA PHARMA, LTD.~E3287GG~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0105364	12/04/1997	OR	57.0	57		F	11/29/1997	did not feel well, achy all over, serious upper resp problem-chest got tighter, constriction in throat;DPH, breathing sxs, pred x 5 days w/tapering dose;			Y	Y					Y	11/21/1997	11/21/1997	0		PVT	OTH	synthroid x 1 daily;Tonormem, estrogen, sulfa, lasix, potassium,clamera, septra, keflex, darvocet, PCN, dodeine;	NONE	pacemaker/3rd degree heart block;	~ ()~~~In patient		1						1	Chest pain; Hypersensitivity; Laryngospasm; Malaise; Myalgia; Pharyngitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0105366	12/04/1997	NY	42.0	42		M	11/20/1997	3wk post vax weakness in upper/lower extremities-hosp;dx inflammation polyneuropathy;				Y	Y	14			N	10/01/1997	11/01/1997	31	inflam polyneuropathy electro diagnostic;	PVT	PVT			pulmonary sarcoid, cholecystectomy, colitis, hlab 27<;	~ ()~~~In patient		1						1	Myasthenic syndrome; Neuropathy	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0105370	12/04/1997	CA	38.0	38		F	11/20/1997	soreness, redness, swelling @ inj  site, hard & raised in middle 3 diameter feels achy & terrible-flushed-stuffy nose;									N	11/19/1997	11/19/1997	0	NONE	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0105373	12/04/1997	CA	67.0			M	11/20/1997	swollen gland-on side pneumo given;pain across shoulders down into arm;														UNK	UNK				~ ()~~~In patient		1						1	Lymphadenopathy; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0105376	12/04/1997	ID	14.0	14		F	11/05/1997	1130AM 31OCT97 pt recv vax;4PM hives on both arms red & itchy called office-referred to PMD;5PM saw MD PDH given hives disappeared spontaneously;									Y	10/31/1997	10/31/1997	0		PUB	PUB	NONE	NONE	keflex, E-mycin, PCN & amoxicillin	~ ()~~~In patient	ID97053	1						1	Pruritus; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~4978146~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105377	12/04/1997	ID	50.0	50		M	10/24/1997	pt recv vax & lt knee started hurting;has had problems w/knee being inflamed;takes motrin & pain goes away prev-but not since 16OCT97;									U	10/14/1997	10/16/1997	2		PUB	PUB		knee problem-but not @ time of vax;	knee inflammed-not @ time of vax;	~ ()~~~In patient	ID97051	1						1	Arthralgia	FLU3~PFIZER\WYETH~4978146~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105378	12/04/1997	ID	78.0	78		F	10/30/1997	pt c/o weakness, shakiness & not feeling right;BG 153 p/gatoraide & crackers;rest, fluids secondary observation;									Y	10/28/1997	10/28/1997	0	blood glucose	OTH	PVT	paxil;Levothyroxine	NONE	diet controlled idabetic	unk~ ()~~~In patient	IK97050	1						1	Asthenia; Hyperglycaemia; Malaise; Tremor	FLU3~PFIZER\WYETH~4978208~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105380	12/04/1997	IL	72.0	72		F		28OCT97 pt recv vax & 3 days later fever, aching;pt had to go to MD for medicine;pt c/o cold sx, chest congestion & coughing up greenish blood tinged mucous;dx bronchitis;				Y					N	10/28/1997	10/31/1997	3		UNK	UNK		NONE	bladder infect & kidney hurting, nose clogg;allergy PCN;	~ ()~~~In patient		1						1	Bronchitis; Cough; Haemoptysis; Lung disorder; Myalgia; Pharyngitis; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0105381	12/04/1997	CA	65.0	65		F	11/05/1997	w/in 24-36hr fatigue, nausea, diarrhea, 6-7 days temp 101.3, extreme fatigue;									Y	10/21/1997	10/22/1997	1	NONE	PUB	PVT	Advil	NONE	NONE	NONE~ ()~~~In patient		1						1	Asthenia; Diarrhoea; Nausea; Pyrexia	FLU3~PFIZER\WYETH~4978200~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105382	12/04/1997	NJ	44.0	44		F	12/02/1997	pt devel a deep constant severe pain in lt deltoid, site of vax 6 inches in diameter for two full days; rxn started 1 1/2wk p/vax;no redness or induration noted;tissue not sore to touch;									Y	11/13/1997	11/18/1997	5	NONE	PUB	PVT	Prevasid;Synthroid;Librax;		hiatel hernia, hypothyroidism, epstein-Barr, allergies bees, dristan, capolosporin, novalene;	~ ()~~~In patient		1						1	Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81917~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105390	12/04/1997	ID	47.0	47		F	10/25/1997	17OCT97 pt became faint p/vax;inj was painful & exp spasms sensation lt arm/hand;BP 102/62, 108/64;pt drank juice & left feeling fine;18OCT97 pt was vacuuming for 1/2hr heart started pounding, rapid heart rate, tightness in throat;lt arm  h									Y	10/17/1997	10/17/1997	0	NONE	PUB	PUB	Premarin;Provera	NONE	NONE	~ ()~~~In patient	ID97046	1						1	Chest pain; Dizziness; Hypertonia; Hypotension; Injection site pain; Laryngospasm; Pain; Tachycardia	FLU3~PFIZER\WYETH~4978164~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105392	12/04/1997	CA	45.0	44		F	11/21/1997	pt c/o lt arm aching progressively worse, cannot really use its, states w/in 1hr of vax felt achy pain;no swelling;whole arm ached for 12hr p/vax;got better & then worse;will see MD 21NOV97;dx bursitis sub acromial;										11/07/1997	11/07/1997	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	CA970110	1						1	Bursitis; Hypokinesia; Myalgia	FLU3~CONNAUGHT LABORATORIES~7F81841~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105396	12/04/1997	ID	79.0	79		M	10/27/1997	chills, fever, shaking did not take temp;fever cause sweating so profuse that change pajama top, covered bed w/heavy bath towel;was sick in bed 10-13OCt;fever, severe chills, shaking so bad required assistance to walk;									Y	10/09/1997	10/10/1997	1	NONE	PUB	PVT	ASA for arthritis;timoptic for glaucoma	NONE	to sulfa drugs;	NONE~ ()~~~In patient	ID97047	1						1	Hyperhidrosis; Hypokinesia; Pyrexia; Tremor	FLU3~PFIZER\WYETH~4978146~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105125	12/05/1997	NY	100.0	100		F	12/04/1997	pt recv vax 27OCT97 & w/in a few hr of inj pt exp fever 103.3, chills & shaking;inc temp cont for two days;29OCT97 temp inc to 106 & pt was pale, blowing resp & expectoration green sputum;pt transferred to a hosp & died on 30OCT97;	Y	10/30/1997			Y	1			N	10/27/1997	10/27/1997	0		UNK	UNK		NONE	no allergies, had degenerative osteoarthritis;had cerebrovvascular insufficiency	~ ()~~~In patient	CO7772	1						2	Chills; Dyspnoea; Pallor; Productive cough; Pyrexia; Tremor; Dyspnoea; Pallor; Productive cough; Pyrexia; Tremor	FLU3~CONNAUGHT LABORATORIES~7F81916~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7F81916~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0105412	12/05/1997	UT	15.0	15		F	11/24/1997	1 day p/got gen sick, earache, ears plugged;p/a few more days trouble hearing, ringing in ears, back pain, pain all over;went to MD 13NOV (2wk later) on 14th while @ lung @ school felt like was going to black out;dx GBS									Y	10/27/1997	10/28/1997	1	blood test;	PUB	PVT	NONE	NONE	NONE	pt sibling devel swelling @ 8mo w/smallpox vax dose 1~ ()~~~In Sibling	UT972545	1						1	Back pain; Deafness; Dizziness; Ear pain; Guillain-Barre syndrome; Malaise; Myalgia; Tinnitus	FLU3~PFIZER\WYETH~4978146~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105413	12/05/1997	NY	71.0	70		M		bell's palsy or guillain barre synd;				Y					N	10/26/1995	11/05/1997	741		UNK	UNK		NONE		~ ()~~~In patient		1						1	Facial palsy; Guillain-Barre syndrome	FLU3~PARKE-DAVIS~00885P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0105414	12/05/1997	MA	76.0	76		F	10/20/1997	redness & warmth lt deltoid;										10/17/1997	10/18/1997	1	NONE	PUB	PUB		NONE	CA -nodes removed lt arm;	~ ()~~~In patient	MA9733	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20037KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0105416	12/05/1997	NM	5.0	5		M	11/11/1997	large wheal 10x15cm @ site of inj;				Y					Y	11/05/1997	11/07/1997	2		PVT	PVT		pharyngitis		NA~ ()~~~In patient	NM97040	1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~4978172~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~441212~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0105419	12/05/1997	MI	44.0	44		F	10/28/1997	3OCT97 6PM pt states felt itchy & got a couple of hives on rt thigh;4OCT97 states took atarax & zantac;states by 6OCT97 was covered w/welts & hives;states face became swollen;6OCT97 seen by MD;meds dec hives;then hives recurring;				Y					Y	10/03/1997	10/03/1997	0		PUB	PUB	allergy shots for environmental allergies synthroid;motrin	NOONE	environmental allergies,hypothyroid, intermittantly eelvated BP	pt exp hives @ 43yr old w/flu vax dose 1;~ ()~~~In patient	MI97146	1						1	Face oedema; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4978197~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105424	12/05/1997	MA	66.0	66		M	11/21/1997	sore, red, swollen, RUA; swelling extended to wrist by next day despite cold application;saw MD & given DPH; some flu-like sx, fever,				Y					Y	11/18/1997	11/18/1997	0		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MA9736	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral	FLU3~MEDEVA PHARMA, LTD.~7F81793~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0993E~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0105427	12/05/1997	IL	71.0	71		F	11/20/1997	fever, n/v, lethargic, pain in lt arm, blister @ site of vax;										10/30/1997	10/31/1997	1	NONE	PUB	UNK	NONE	NONE	NONE	~ ()~~~In patient	IL97107	1						1	Injection site hypersensitivity; Pain; Pyrexia; Somnolence; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E3327GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0105434	12/05/1997	MI	69.0	69		F	10/22/1997	c/o uncontrollable shivers for 1/2hr & cold forehead hot but did not take temp, weak, inc urination, inc thirst;called 911 but did not want to got to hosp;RP was up & had enough 02 in blood;									Y	10/21/1997	10/21/1997	0		PUB	UNK				~ ()~~~In patient	MI97148	1						1	Asthenia; Hypertension; Pollakiuria; Thirst; Tremor; Vasodilatation	FLU3~PFIZER\WYETH~4978196~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~431805~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~7C91556~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0105437	12/05/1997	UT	74.0	73		F		red, tender rt arm, hot to touch, size of a quarter devel 12hr p/vax;also reported hives to the groin area w/in 24hr;									Y	10/14/1997	10/15/1997	1	NONE	UNK	UNK	Premarin;THyroid	NONE	sarcoidosis	pt exp rxn in 1952 w/tetanus;~ ()~~~In patient	UT971844	1						1	Pain; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4978146~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~2~SC~LA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~7E91657~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0105438	12/05/1997	NM	20.0	20		M	11/13/1997	fine macular rash over arm bilat-total length w/mild swelling, also over upper 1/2 trunk-inc on back;pt had flu sx approx 10 days earlier;									Y	11/12/1997	11/13/1997	1		PUB	PUB		NONE		~ ()~~~In patient	NM97039	1						1	Influenza; Oedema peripheral; Rash maculo-papular	FLU3~PFIZER\WYETH~4978165~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105440	12/08/1997	FL	34.0	34		M		development of lt facial nerve paralysis/palsy;								Y		10/29/1997	11/04/1997	6	SMAC/CBC/sed rate WNL;	UNK	UNK			NONE	~ ()~~~In patient		1						1	Facial palsy; Facial palsy	FLU3~CONNAUGHT LABORATORIES~306423~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~306423~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Disabling	Influenza
0105451	12/08/1997	FL	41.0	41		F	11/28/1997	lt arm weakness, also c/o buzzing feeling between lt shoulder & elbow;				Y					N	10/29/1997	11/01/1997	3	no tests-to pvt neurologist PRN	PVT	PVT	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Myasthenic syndrome; Paraesthesia	FLU3~PFIZER\WYETH~4978188~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105456	12/08/1997	WA	27.0	27		M	10/22/1997	pt recv vax 9OCT97 felt fuzzy & warm throughout the day;10OCT97 devel a warm feeling 11OCT97 sore throat & fever cont to have sore throat & fever for 6 days;went to MD & 5th day did strep cult results unk;				Y					Y	10/09/1997	10/10/1997	1	16OCT97 strep cult done no results	OTH	OTH		NONE	NONE	~ ()~~~In patient	WA971411	1						1	Paraesthesia; Pharyngitis; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4978174~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105459	12/08/1997	VA	28.0	28		F	12/03/1997	urticarial rxn, arms, face, thighs, trunk;no resp cyanosis;				Y					Y	12/02/1997	12/02/1997	0	NONE	PUB	UNK		NONE	NONE	NONE~ ()~~~In patient		1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81746~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105464	12/08/1997	MD	65.0	64		M	11/17/1997	sore throat, cramps, diarrhea, chest congestion, upper resp sx w/cough, yellow productive sputum & muscle aches;T99;				Y					U	11/03/1997	11/06/1997	3	NONE	PUB	PUB	synthroid Micronaise, hydrin	NONE	diabetic, allergy to PCN & indocin	pt exp cold p/flu shot in 1996;~ ()~~~In patient		1						1	Cough; Diarrhoea; Lung disorder; Myalgia; Pain; Pharyngitis; Productive cough; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E20067KF~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0105466	12/08/1997	WA	54.0	54		F	11/21/1997	diffuse myalgia, arthralgias, malaise 24hr p/vax 18NOV97;										10/18/1997	10/19/1997	1	CBC, ESR, chem panel, ANA, RA;	MIL	MIL	slow K, calcium supplement;ASA, prilosec	NONE	NONE	NONE~ ()~~~In patient		1						1	Arthralgia; Malaise; Myalgia	FLU3~PFIZER\WYETH~4976774~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105469	12/08/1997	AR	34.0	34		F	11/24/1997	pt states 1-1 1/2 days p/vax pt exp pain, & muscle weakness from lt neck down to below lt elbow-last couple of days has exp pain in lt rib, underarm area;										10/27/1997	10/28/1997	1		PUB	UNK				~ ()~~~In patient	AR9793	1						1	Injection site pain; Lymphadenopathy; Myasthenic syndrome; Neck pain; Pain	FLU3~CONNAUGHT LABORATORIES~7F81803~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105470	12/08/1997	AR	43.0	43		F	11/10/1997	pain, nausea, temp went home from work & went to bed;took APAP;									Y	10/20/1997	10/20/1997	0	NONE	PUB	PUB	Estrogen	NONE	NONE	NONE~ ()~~~In patient	AR9789	1						1	Nausea; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81803~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105476	12/08/1997	WA	55.0	55		F	10/15/1997	feeling achy, sore in neck, lt arm swollen, red & warm @ shot site;this started 4-5 days p/shot & lasted 4-5 days;(not sure of date of onset);PS neck sore & stiff, hard to hold head up;										10/06/1997	10/11/1997	5		PUB	PUB		NONE	diabetic	~ ()~~~In patient	WA971408	1						1	Hypokinesia; Injection site hypersensitivity; Injection site oedema; Myalgia; Neck pain; Nuchal rigidity; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81832~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~7D91611~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0105477	12/08/1997	WA	48.0	48		M	10/24/1997	sudden onset of h/a, fever @ 630AM on day p/vax;T101 some aching & severe h/a;relieved by APAP;sx dec by MN;pt is afeb w/o h/a now;										10/22/1997	10/23/1997	1	NONE	PUB	PUB	Lodine, diazepam;	NONE	pollen & grass;	~ ()~~~In patient	WA971407	1						1	Headache; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4978146~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0221D~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0105479	12/08/1997	NE	56.0	56		F	12/03/1997	localized pain, redness, swelling in rt deltoid area;body aches & pain;tx ice, pain med;									Y	11/25/1997	11/25/1997	0	NONE	PVT	UNK		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~7F81829~5~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~448188~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0105481	12/08/1997	MD	60.0	60		F	11/19/1997	sore throat, mild cramps & diarrhea;progressed to head cold & rattling chest, stopped up nose, production cough-yellow sputum;didn't take temp;states that upper resp sx are inc in severity to date 19NOV97;									U	11/03/1997	11/07/1997	4	NONE	PUB	PUB	NONE	NONE	degenerative disc., arthritis	chills, aching p/flu shot 1996;~ ()~~~In patient		1						1	Cough; Diarrhoea; Lung disorder; Muscle spasms; Pharyngitis; Productive cough; Rhinitis	FLU3~MEDEVA PHARMA, LTD.~E20067KF~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0104994	12/09/1997	PA	39.0	39		F	12/01/1997	pt recv vax on 22OCT97 & pt treated in ER on 24OCT97 edema w/erythema in prox lt arm, wheals, +pulses;				Y					Y	10/22/1997	10/23/1997	1		PUB	UNK			NKDA	~ ()~~~In patient		1						2	Oedema peripheral; Pruritus; Urticaria; Oedema; Rash; Tachycardia; Urticaria	FLU3~PFIZER\WYETH~4978207~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4978207~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0105543	12/09/1997	IN	52.0	52		M	12/02/1997	flu like sx wk of 17NOV96 & again wk of 8DEC96;pain in neck & shoulders 23DEC96;weakness 24DEC96;collapsed in floor 26DEC96;hosp 27DEC97 transferred to rehab ctr 31JAN97;totally paralyzed staph pneumonia;T107.4;			Y	Y	Y	35	Y	Y	N	11/12/1996	11/18/1996	6	blood test, spinal tap, MRI, NCV, EMG, EKG	UNK	UNK	ASA;Valium, Vicodin, Procan, Daypro		SDMA coumpound, nalfon;degenerative disc disease lumars	~ ()~~~In patient		1						1	Hypotension; Hypoxia; Infection; Influenza; Neck pain; Paralysis; Pneumonia; Syncope	FLU3~CONNAUGHT LABORATORIES~7F71277~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0105544	12/09/1997	WI	33.0	33		M	12/02/1997	23OCT97 devel numbness of tongue & perioral area;numbness proceeded to arms, legs;tx w/human immunoglobulin, APAP;2DEC97 f/u still weak, back to work 1/2day today;dx w/GBS;				Y	Y	6			Y	10/13/1997	10/23/1997	10	testing to r/o other illness, dx w/GBS	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome; Paraesthesia; Paraesthesia oral; Tongue disorder	FLU3~PFIZER\WYETH~4978194~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0105552	12/09/1997	TX	27.0	27		F	11/19/1997	13OCT97 815PM pt recv vax & 2hr later exp tingling & edema @ site w/o wheal;10PM edema gradually spread to fingers;17OCT flu-likes sx w/o fever;no sx @ site or arm;20OCT dx URI per PMD placed on keflex & claritin-D arm & hand WNL;				Y					Y	10/13/1997	10/13/1997	0		PUB	PUB	NONE	NONE	allergies-1996 pneumonia	~ ()~~~In patient	TX97153	1						1	Influenza; Injection site oedema; Oedema peripheral; Paraesthesia; Pharyngitis	FLU3~MEDEVA PHARMA, LTD.~E3297GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0332D~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0105553	12/09/1997	OH	45.0	45		F	11/14/1997	the day p/vax devel h/a, red face, dizzy, 4 welt @ inj site;about a wk later became ill & went to MD & was told had the old fashion flu;was checked for bacterial meningitis negative;				Y					Y	10/15/1997	10/16/1997	1	NONE	PUB	OTH	Premarin	NONE	a yr ago suffered from severe sunburn of both arms that has left arms weak;	~ ()~~~In patient	OH97092	1						1	Dizziness; Headache; Infection; Influenza; Injection site hypersensitivity; Malaise; Meningitis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81788~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105560	12/09/1997	OR	1.3	1	.3	M	12/01/1997	febrile seizure 24hr p/vax;				Y					Y	11/24/1997	11/25/1997	1	LP negative, blood cult CBC	PVT	PVT	NONE	cough, congestion	NONE	~ ()~~~In patient		1						1	Febrile convulsion	FLU3~CONNAUGHT LABORATORIES~7F81854~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105563	12/09/1997	AL	47.0	47		F	12/02/1997	pt reports severe aching in joints & fever of 102 then diarrhea started 22OCT97;advised to see MD which did on 23OCT97;MD felt synd were not caused by flu vax according to pt;				Y					Y	10/21/1997	10/22/1997	1		UNK	PVT		NONE	NONE	~ ()~~~In patient		1						1	Arthralgia; Diarrhoea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105565	12/09/1997	VA	62.0	62		M	12/02/1997	pt recv vax 230PM muscle soreness & itching began & became severe by 7PM;area became red & warm to touch;pt visited MD again on 8NOV @ approx 10AM;edema noted @ inj site;pt told to use DPH, ice & advil for pain;				Y					Y	11/07/1997	11/07/1997	0	NA	PVT	PVT		NONE	allergies;ASA, phenobarb, IVP dye;pt has arthritis	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Myalgia; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81916~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~445639~2~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0105567	12/09/1997	NM	33.0	33		F	11/20/1997	post inj & laying on it that noc for past 3-4 days has really hurt-can't lift arm-hurts to drive-went to MD;fluid built up muscle or it looks like it;				Y						11/05/1997	11/15/1997	10	NONE	PUB	PUB	Tagmet	denied	denied	NA~ ()~~~In patient	NM97041	1						1	Hypokinesia; Oedema peripheral; Pain	FLU3~PFIZER\WYETH~4978165~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105569	12/09/1997	TX	76.0	76		F	10/30/1997	pt recv vax 27OCT97 & had no problems until 30OT97 redness & tenderness to rt arm;no signs of infect;										10/27/1997	10/30/1997	3		PUB	PUB		NONE	NKA	~ ()~~~In patient	TX97144	1						1	Injection site hypersensitivity; Injection site pain	FLU3~MEDEVA PHARMA, LTD.~E32976A~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~CONNAUGHT LABORATORIES~7C91574~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0105571	12/09/1997	TX	69.0	69		F	11/06/1997	about 4hr p/vax lt deltoid area became red & swollen no temp;presented today no temp sl redness-small amount of swelling approx 4 in diameter;sore to touch-hurts on movement;									U	11/05/1997	11/05/1997	0	NONE	PUB	PUB		NONE	bilateral mastectomy-was given in arms;	~ ()~~~In patient	TX97148	1						1	Hypoaesthesia; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3297GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0105574	12/09/1997	TX	58.0	57		F	11/14/1997	pt presented to clinic w/ c/o lt upper arm redness & discomfort radiating up into neck redness/raised area approx 4cm x 2cm indurated urticaria;									Y	11/04/1997	11/06/1997	2	BA	PVT	PVT	Beclovent-Magnesium;Proventil, Premproc;Prozac, Synthroid;	NONE	allergy PCN, keflex	NA~ ()~~~In patient	TX97154	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Neck pain; Skin nodule; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81884~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~445636~1~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0105576	12/09/1997	OH	60.0	60		F	10/31/1997	pt states w/in 30min p/vax devel severe h/a & localized rxn @ the site of inj (red, swollen, warm to touch), states also got a rash on face & swelling;states h/a & rash are still present;advised to talk to MD									Y	10/28/1997	10/28/1997	0	NONE	PUB	PUB	Asulfadine	NONE	Crohn's disease	NONE~ ()~~~In patient	OH97091	1						1	Face oedema; Headache; Injection site hypersensitivity; Injection site oedema; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81917~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105586	12/09/1997	VA	62.0	62		F	12/02/1997	pt recv vax 7NOV97 2PM inj site very painful & sore by 7PM;pt was instructed to use ice & advil for pain;									Y	11/07/1997	11/07/1997	0	NA	PVT	PVT		NONE	NKDA HTN	~ ()~~~In patient		1						1	Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81916~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~445639~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0105588	12/09/1997	IL	81.0	81		F	12/05/1997	pt presented for pre-op hx of physical & had a fading bruise from flu vax;no problems;									Y	10/15/1997	10/16/1997	1	NONE	PVT	PVT	Cardura, univasc, nitro patch, zocor	HTN, atrial fib, hypercholesterolemia	quinidine-diarrhea;	~ ()~~~In patient		1						1	Ecchymosis	FLU3~CONNAUGHT LABORATORIES~7F81752~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105597	12/09/1997	CT	33.0	32		M	12/04/1997	rxn @ inj site;6cm erythemic warm area;									Y	12/01/1997	12/01/1997	0	NONE	MIL	MIL	NONE		allergy to orange peel, seasonal allergies;	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7J81934~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105603	12/10/1997	SC	13.0	13		M	11/14/1997	pt c/o local redness & swelling in arm p/vax 10NOV97, cont w/pain redness inc to lt elbow & arm w/severe swelling 11NOV97;seen by MD & referred to MD dx w/cellulitis lt arm & started on oral keflex;				Y					Y	11/09/1997	11/10/1997	1	x-rays of arm & joint lt elbow, CBC	OTH	PUB	servent, rinecert puffs, clartin each nostril	NONE	asthma	NONE~ ()~~~In patient	SC970	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~MEDEVA PHARMA, LTD.~E3287GA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0906E~1~SC~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0105604	12/10/1997	OH	49.0	49		F	11/28/1997	30OCT 24hr pain entire arm & hand;arm & under arm sore;med given didn't work-nothing really helped;13NOV shoulder x-ray & EMG p/5 wk some pain & some numbness down arm & hand;				Y					N	10/29/1997	10/30/1997	1	shoulder x-ray nl;EMG satisfactory	PUB	PVT	NONE	NONE		~ ()~~~In patient		1						1	Lymphadenopathy; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~7F81929~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105605	12/10/1997	SC	53.0	53		F	10/24/1997	4 1/2 x 3-1/2 thick, red, hot, painful, chills & fever that noc & Thursday noc;muscle under arm still joint to work-sx stranger today 24OCt97 than 23OCT97;									U	10/22/1997	10/22/1997	0		PUB	PUB		NONE		~ ()~~~In patient	SC97064	1						1	Myalgia; Oedema peripheral; Pain; Pyrexia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3287GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0906E~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0105440	12/11/1997	FL	34.0	34		M		development of lt facial nerve paralysis palsy;								Y		10/29/1997	11/04/1997	6	SMAC;CBC;Sed rate WNL;	UNK	UNK			NONE	~ ()~~~In patient		1						2	Facial palsy; Facial palsy	FLU3~CONNAUGHT LABORATORIES~306423~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~306423~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Disabling	Influenza
0105606	12/11/1997	ND	11.0	10		M	11/04/1997	temp, vomiting, confusion/delirium;severe h/a;					Y	2			Y	10/31/1997	11/01/1997	1	glucose nl, NH3, mild inc transuninase	PVT	PVT		NONE	asthma, allergic rhinitis	NONE~ ()~~~In patient	ND9723	1						1	Alanine aminotransferase increased; Confusional state; Delirium; Headache; Hyponatraemia; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~4978168~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0105612	12/11/1997	MD	52.0	52		M	12/10/1997	pt recv vax 21OCT97 or 28OCT97 & approx 1hr p/vax became nauseous, felt like was going to pass out & started to wheeze;high fevers, burning in head, abn thinking;								Y	U	10/21/1997	10/21/1997	0	NONE	OTH	OTH	Provex CV		allergics eggs confirmed by +skin & +RAST scats;mult chem sensitiities;allergic to metals & phenols;toxic effect of other pesticides, not elsewhere calssified status;hx chronic fever since 1972 may be d/to toxic exposures;sensory problem;	NONE~ ()~~~In patient	MPI971030	1						1	Asthma; Condition aggravated; Dizziness; Nausea	FLU3~MEDEVA PHARMA, LTD.~~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0105615	12/11/1997	MD				M	12/10/1997	pt recv vax & faint & cont to fell lightheaded;pt exp little pain in the am;5NOV went to pulmonary rehab;passed out;blood pressure jumped to 240;pt exp trouble walking;MD prescribed 02;dizzy spells;running nose;				Y					N	10/31/1997	10/31/1997	0	EKG, CXR, bllod test, BP monitoring for a couple of hr; sinus CAT scan;	UNK	UNK	Atrovent inhaler, Theodur, Verelan, Combivent inhler, Serevent inhaler;		chronic obstructive pulmonary disease	pt was sick w/flu vax;~ ()~~~In patient		1						1	Dizziness; Gait disturbance; Hypertension; Hypokinesia; Pain; Rhinitis; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0105617	12/11/1997	NY	57.0	57		F	12/05/1997	pt notified ER nurse on 21OCt97 that had been exp pain in lt arm since flu vax;pt advised to see MD if pain cont which it did;MD feels this is coincidental & is more likely d/t a pinched nerve;pt is taking physical therapy;x-rays ordered;				Y					N	10/06/1997	10/06/1997	0		PVT	PVT	Accupril;Furosemide	NONE	HTN, hypercholesterolemia	~ ()~~~In patient		1						1	Pain	FLU3~MEDEVA PHARMA, LTD.~E3277MB~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0105619	12/11/1997	SC	48.0	48		F	11/04/1997	630PM SOB, chest congestion & tingling around mouth, tongue numbness lasted about 1hr;took DPH & liquid DPH;									Y	10/28/1997	10/28/1997	0	NA	PUB	PUB	NONE	NONE	allergic to ASA & PCN	NONE~ ()~~~In patient	SC97085	1						1	Dyspnoea; Lung disorder; Paraesthesia oral; Tongue disorder	FLU3~MEDEVA PHARMA, LTD.~E3287GH~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0105624	12/12/1997	SC	62.0	62		M	11/12/1997	late Friday PM 17OCT97 T102.8, sl swelling & redness lt pt started taking 2 advil q 4hr sat AM, temp cont 102;pt exp swelling & redness lt arm;				Y					Y	10/16/1997	10/17/1997	1		PUB	PUB	NONE	NONE	NKA	NA~ ()~~~In patient	SC97089	1						1	Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Pyrexia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3287GA~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1173E~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0105628	12/12/1997	TX	25.0	25		M	11/25/1997	c/o pain & limited movement in lt arm & shoulder since having flu shot;				Y					N	10/24/1997				OTH	PVT		NONE		~ ()~~~In patient		1						1	Hypokinesia; Pain	FLU3~CONNAUGHT LABORATORIES~7F81885~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105629	12/12/1997	TX	45.0	44		F	11/25/1997	c/o pain lt arm & shoulder upon receiving flu vax;limited movement in arm & cannot sleep on arm;has seen chiropractor, MD & now having physical therapy;				Y					N	10/23/1997				OTH	PVT		NONE		~ ()~~~In patient		1						1	Hypokinesia; Insomnia; Pain	FLU3~CONNAUGHT LABORATORIES~7F81885~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105630	12/12/1997	TX	49.0	49		F	12/03/1997	c/o pain @ site of inj & into shoulder w/limited movement;				Y					N	10/13/1997	10/13/1997	0		PVT	PVT				~ ()~~~In patient		1						1	Hypokinesia; Injection site pain; Pain	FLU3~CONNAUGHT LABORATORIES~7F81885~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105631	12/12/1997	TX	44.0	43		F	12/03/1997	c/o pain @ site of inj into lt shoulder;limited movement of arm;				Y					N	10/13/1997	10/17/1997	4		PVT	PVT				~ ()~~~In patient		1						1	Hypokinesia; Injection site pain; Pain	FLU3~CONNAUGHT LABORATORIES~7F81885~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105632	12/12/1997	TX	35.0			F	12/08/1997	c/o pain & limited movement in rt arm & shoulder p/vax;				Y					N					PVT	PVT				~ ()~~~In patient		1						1	Hypokinesia; Pain	FLU3~CONNAUGHT LABORATORIES~7F81885~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105634	12/12/1997	VA	32.0	32		F	12/04/1997	redness, swelling inj site, fever 101, white count 27,900;				Y					Y	12/01/1997	12/03/1997	2	white count 27,900;	PVT	PVT		NONE	allergies to dust, mold, dogs;	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Leukocytosis; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1054D~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0105637	12/12/1997	NC	57.0	57		M	12/02/1997	rt arm swollen & hurting;took something for pain;pt went to ER;									Y	11/25/1997				PUB	PUB	punemo vax 1990		emphysema	~ ()~~~In patient	NC97118	1						1	Oedema peripheral; Pain	FLU3~CONNAUGHT LABORATORIES~7F81929~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TTOX~CONNAUGHT LABORATORIES~7F91694~UNK~~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0105640	12/12/1997	SC				F	10/17/1997	husband called & stated pt recv vax 14OCT97 & was nauseous, fever, red/hot spot, swollen area;husband thought this was d/t vax since  wife had flu prev;RN suggested cool compresses, APAP for next 24hr;flu vax pre drawn;pneum drawn 1 needle									Y	10/14/1997	10/15/1997	1		PUB	PUB	NA	NA	NA	~ ()~~~In patient	SC97067	1						1	Nausea; Oedema; Pyrexia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3287GA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0906E~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0105642	12/12/1997	SC	70.0	70		F	11/05/1997	pt reported @ 3x4 redness an arm given pneumonia w/some tenderness fine days p/vax;no other c/o no fever, no illness;;									Y	10/23/1997	10/28/1997	5		PUB	PUB		NONE	NONE	~ ()~~~In patient	SC97079	1						1	Injection site hypersensitivity; Injection site pain	FLU3~MEDEVA PHARMA, LTD.~E3287GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0906E~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0105643	12/15/1997	TX	31.0	31		F	12/08/1997	sxs of ascending paralysis GBS dx by neuro MD;			Y	Y					U	10/20/1997	11/12/1997	23	neurologist dx w/tests;	PUB	PUB	unk	NONE	unk	~ ()~~~In patient	TX97165	1						1	Guillain-Barre syndrome; Paralysis; Guillain-Barre syndrome; Myasthenic syndrome; Neuropathy; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~7F81723~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7F81723~3~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening	Influenza
0105651	12/15/1997	LA	42.0	42		F	12/11/1997	URI, diff breathing									N	12/04/1997	12/08/1997	4		PUB	PVT				~ ()~~~In patient		1						1	Dyspnoea; Pharyngitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0105643	12/16/1997	TX	31.0	31		F	12/11/1997	pt recv vax 20OCT97 & 12NOV97 was reported as the date of the onset of the event;4DEC97 pt dx w/GBS by a neurologist;				Y					N	10/20/1997	11/12/1997	23		UNK	UNK				~ ()~~~In patient	CO7788	1						2	Guillain-Barre syndrome; Paralysis; Guillain-Barre syndrome; Myasthenic syndrome; Neuropathy; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~7F81723~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7F81723~3~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0105656	12/16/1997	MN	66.0	66		F	12/12/1997	10 days p/vax pt devel GBS unsure of connection;			Y	Y	Y	40				10/10/1997	10/17/1997	7		OTH	PVT		NONE		~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0105670	12/16/1997	NC	84.0	84		F	12/08/1997	resident had a hypoglycemic rxn 6hr p/vax;resident is not a diabetic;blood glucose was 17;					Y	7			Y	10/27/1997	10/27/1997	0	after episode beta-2-microglobulin was 4.40 rang was 1.20-2.80-no insulin was given by this facility	UNK	PVT	TImoptic, pilocarpine;atarax;coumadin;tegretrol, dilantin, lanoxin, synthroid	NONE	NKA	~ ()~~~In patient		1						1	Hypoglycaemia	FLU3~CONNAUGHT LABORATORIES~7F81883~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0105671	12/16/1997	RI	67.0	67		F	10/09/1997	315PM pt recv vax & 330PM pt c/o difficulty breathing & feeling warm;BP 170/70, AP 80, RR 32;resp labored, pale, anxious;epi given w/some relief;				Y	Y				N	10/09/1997	10/09/1997	0		PUB	UNK		NONE	angina, diabetes	~ ()~~~In patient		1						1	Anxiety; Dyspnoea; Hypertension; Hyperventilation; Pallor; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81856~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0105716	12/16/1997	MS	27.0	27		F	12/05/1997	30min p/vax pt had a flu-like feeling 24hr later had a reddened area about 1 1/2 in diameter 48hr later a reddened area the size of the palm of hand, fever of 102 5 days later red raised area from should to elbow;				Y					Y	11/03/1997	11/03/1997	0		PUB	PUB	Insulin		diabetes	~ ()~~~In patient	MS97051	1						1	Influenza; Oedema peripheral; Pyrexia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20037KA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~441214IM~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0105721	12/16/1997	NC	79.0	79		M		erythema, pain, warmth of majority of rt arm (site of pneumovax);				Y					U	12/08/1997	12/08/1997	0	NONE	PVT	PVT	HCTZ, KDUR	NONE	leukemia	~ ()~~~In patient	NC97119	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81741~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~445642~2~~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0105723	12/16/1997	PA	6.0	6		F	11/05/1997	mom reported in AM of 5NOV pt had temp of 103 @ 9PM not c/o anything specific;acting well by next AM;temp of 103.2 3AM the next noc;6NOV c/o sore throat;was on amoxil prior to vax;prolonged URI sx;									Y	11/04/1997	11/04/1997	0		PVT	PVT	Dilantin	prolonged cough;amoxil since;	complex/partial sz	pt exp sx 22JAN93 @ 14mo w/DTP/OPV 6JAN93 dose 4;~ ()~~~In patient	PA9769	1						1	Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7J81858~1~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SMITHKLINE BEECHAM~2352A2~1~IM~LA~HEP B (ENGERIX-B)~1	USA		Influenza
0105726	12/16/1997	WA	22.0	22		F	12/01/1997	pt states had swelling rt upper arm & shoulder x 3-4 days p/inj;states painful x 2 days then 31 days p/devel pain rt deltoid area-area tender to palpation & sl swollen;									U	10/03/1997	10/30/1997	27	ESR-WNL;	PUB	UNK	topical steroids	NONE	PCN, septra, weeds, grass, molds	pt exp swelling, redness @ 21yr old w/flu vax & Td  dose 1~ ()~~~In patient		1						1	Hypoaesthesia; Oedema peripheral; Pain	FLU3~PFIZER\WYETH~4978156~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105730	12/16/1997	MI	66.0	66		M	11/18/1997	c/o swollen knee & ankle joints 2 days p/vax & 16OCT97 pt saw MD 29OCT for PSA test & sx reported to him;APPA PRN prescribed but not taken;										10/16/1997	10/18/1997	2	NONE	PUB	PUB	NONE	NONE	c/o arthritic joints-mild prior to vax	NONE~ ()~~~In patient	MI97153	1						1	Osteoarthritis	FLU3~PFIZER\WYETH~4978178~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~~1~IM A~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0105731	12/16/1997	MI	67.0	67		F	11/24/1997	pt recv vax 14NOV97 states itching to area on 21NOV97 noticed redness surrounding inj site on 22NOV97 cont until present time;ring of erythema approx 2 inches from center of in site;									U	11/14/1997	11/22/1997	8		PUB	PUB	Cozaar;Sectral;Maxide;Asacol-antivert	NONE	allergic to PCN	NA~ ()~~~In patient	MI97154	1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~4978196~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~7C91556~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0105733	12/16/1997	CA	68.0	68		F	12/10/1997	urticaria all over body;started same day as inj given;									Y	11/18/1997	11/18/1997	0	NONE	PVT	PVT	Orthoest;Provera;	NONE	NONE	~ ()~~~In patient		1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~7F1788~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~436124~UNK~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0105734	12/16/1997	WA	45.0	44		F	12/02/1997	6cm round, hot, red, raised, painful inj site x 6 days;onset 12hr p/vax;									Y	11/17/1997	11/18/1997	1	NONE	PUB	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4978202~5~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105736	12/16/1997	RI	45.0	45		M	10/30/1997	approx 10min p/vax pt became dizzy, weak, very pale, clammy, BP 80/40, P40, R20;pt was alert w/no resp distress;called 911;EMT arrived;did full assessment;pt recovered;									Y	10/30/1997	10/30/1997	0	NA	PUB	PVT	NONE	healthy	NONE	~ ()~~~In patient		1						1	Asthenia; Bradycardia; Dizziness; Hyperhidrosis; Hypotension; Pallor	FLU3~CONNAUGHT LABORATORIES~7F81899~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105739	12/16/1997	MS	36.0	36		F	11/21/1997	states Wednesday noc rt arm begin to hurt was unable to touch;states arm was swollen bad Thursday;red area noted where pneumo shot was given;some redness noted @ that time on elbow-swelling radiated down to elbow;muscle tight arm red & hot									Y	11/19/1997	11/19/1997	0		PUB	UNK				~ ()~~~In patient	MS97050	1						1	Hypoaesthesia; Oedema peripheral; Pain; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3287GB~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0585D~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0105742	12/16/1997	WI	42.0	42		M		unilateral rt hearing loss lasting 18hr requiring no tx hearing test taken;									Y	10/07/1997	12/12/1997	66	hearing test	PUB	UNK		NONE	NONE	~ ()~~~In patient		1						1	Deafness transitory	FLU3~PFIZER\WYETH~4978168~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105745	12/17/1997	MD	77.0	77		M	12/11/1997	son was retrieving late fathers personal effects & found flu vax recv, noting date given was w/in 24hr of father's death;stated wanted us to be aware in case this was part of a larger problem;father lived alone;	Y	11/22/1997							N	11/21/1997	11/22/1997	1	medical examiners case	PUB	PUB	unk	unk	unk	NA~ ()~~~In patient	MD97020	1						1	Unevaluable event	FLU3~MEDEVA PHARMA, LTD.~E20017HA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0105750	12/17/1997	CA	79.0	79		F	11/19/1997	pt niece stated that pt eyes became red & watery 2hr p/vax & @6PM c/o diarrhea was weak, unable to stand, shaking, sweating, had irregular heart beat, looked as if was going to pass out, elevated temp @ ER;				Y	Y				U	11/17/1997	11/17/1997	0		PUB	UNK	Benazopril;ASA;vits;	NONE	HTN & atial fib	~ ()~~~In patient		1						1	Arrhythmia; Asthenia; Conjunctivitis; Diarrhoea; Hyperhidrosis; Lacrimal disorder; Pyrexia; Tremor	FLU3~CONNAUGHT LABORATORIES~7F81898~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0105751	12/17/1997	CA	34.0	34		F		muscle fatigue/overall malaise poss rheumatoid arthritis recently dx;								Y	N	10/03/1995	10/04/1995	1	low blood platelets;elevated rheumatoid factor;carpal tunnel synd	PVT	PVT		NONE	rheumatoid arthritis;	~ ()~~~In patient		1						1	Condition aggravated; Laboratory test abnormal; Malaise; Myasthenic syndrome; Paraesthesia; Rheumatoid arthritis; Tenosynovitis; Thrombocytopenia	FLU3~CONNAUGHT LABORATORIES~5F61113~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0105755	12/17/1997	MA	68.0	67		F	12/09/1997	fever, chills: aching bones, exhaustion;dizzy, earache;went to bed;drank fluids & took Bufferin;lasted through 3DEC tired very quickly during past week;									Y	11/05/1997	11/23/1997	18	NONE	PUB	PUB	Levoxyl	NONE	NONE	~ ()~~~In patient	MA9738	1						1	Asthenia; Bone pain; Dehydration; Dizziness; Ear pain; Pyrexia; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0105769	12/17/1997	TN	42.0	42		F	12/10/1997	numbness/tingling lt foot & tingling rt hand started 4 days p/vax;was intermittent;stopped p/3 days & began again & got worse in rt hand extending to elbow 2 days later stopped 2 days later;									Y	11/20/1997	11/24/1997	4	NONE	PVT	OTH	NONE	NONE	mild asthma	NONE~ ()~~~In patient		1						1	Paraesthesia	FLU3~PFIZER\WYETH~4978287~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105775	12/17/1997	MN	55.0	54		M	12/10/1997	hives, itching pt called to clinic;told to take DPH & call clinic back if no improvement;									U	12/10/1997	12/10/1997	0	NONE	PVT	PVT		NONE	PCN	~ ()~~~In patient		1						1	Pruritus; Urticaria	FLU3~PFIZER\WYETH~4978212~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105785	12/18/1997	CA	78.0	78		F	12/08/1997	3hr p/vax fever, sore throat 6hr later 9PM welts started Wednesday when got up;welts on lt arm;later chest, shoulder blades other arm genitals;referred to MD;				Y					N	11/10/1997	11/10/1997	0	NONE	PUB	PUB	NONE	NONE	possible neomycin, wool	pt recv flu vax & devel fever, malaise @ 30yr old w/smallpox dose 1;~ ()~~~In patient	CA970115	1						1	Pharyngitis; Pyrexia; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81841~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105786	12/18/1997	CA	34.0	34		F	12/08/1997	3hr p/vax sore arm;next day sore arm & stiff neck on rt;missed 6hr work on Friday 5DEC97;took non steroidal anti inflam;referred to PMD;									U	12/02/1997	12/02/1997	0	NONE	PUB	PUB	NONE	NONE	surgery 3NOV97 tubal & oopharectomy PCN, codeine;	pt exp sore arm w/Td, flu vax~ ()~~~In patient	CA970116	1						1	Myalgia; Neck pain	FLU3~CONNAUGHT LABORATORIES~7F81841~5~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105789	12/18/1997	MD	32.0	32		M	12/12/1997	numbness, tingling, drooping lt side of face;Bell's palsy;										10/30/1997	11/17/1997	18	HIV;antiHB's;ESR;lyme disease antibody;	UNK	UNK				~ ()~~~In patient		1						1	Facial palsy; Paraesthesia	FLU3~PFIZER\WYETH~4978191~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105803	12/19/1997	SC	55.0	55		F	12/03/1997	large red area (1 1/2-2 in diameter) around inj site for approx 2wk;area was swollen, hard, & felt hot to touch;area itched quite a bit for 2 to 3 wk p/inj;									Y	11/03/1997	11/03/1997	0		OTH	PUB	Synthroid;Minipress, Ibuprofen, maxzide, prempro, allegra;	NONE	HTN, hypothyroidism, arthritis, sinus/allergy	~ ()~~~In patient	SC97092	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pruritus; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3287GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0105812	12/19/1997	WA	38.0	38		M	12/01/1997	pt recv vax 9OCT97 & triceps muscle area became sore by 12OCT97 lt arm seemed to became weak;lt arm w/marked avoidance of lifting;										10/09/1997	10/12/1997	3		OTH	OTH	NONE	NONE	NONE;	~ ()~~~In patient		1						1	Hypokinesia; Myalgia; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~7F81736~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105810	12/22/1997	OH	44.0	44		M	12/16/1997	2NOV97 pt recv vax & pre-adm to hosp for chemo;6NOV97 d/c in AM  general weakness, SOB, neuropathy;by 930PM 100% vent dependent, paralysis, tetra plegic;dx & tx for neuroblastoma;			Y		Y			Y		11/02/1997	11/06/1997	4	oncologists, radiologists stated nothing went wrong during chemo w/either doses or type of administration;MRI revealed swelling around spinal cord;	UNK	UNK			NKA;	~ ()~~~In patient		1						1	Asthenia; Depressed level of consciousness; Dyspnoea; Hypoxia; Neuropathy; Oedema; Paraplegia; Sarcoma	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0105818	12/22/1997	OK	17.0	17		F	11/20/1997	pt recv vax 22OCT97  AM & 1PM mom reported pt had a car accident p/left clinic several blocks away;pt reported seeing dots before her eyes & having trouble moving arms & legs & then hit 2 other cars;pt treated & released from ER;				Y					Y	10/22/1997	10/22/1997	0		PUB	PUB	NONE	denied before shot given	NONE	NONE~ ()~~~In patient	OK9743	1						1	Hypokinesia; Injury; Visual disturbance	FLU3~MEDEVA PHARMA, LTD.~E3277GA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0105819	12/22/1997	MI	51.0	50		F	12/10/1997	noticed throat felt swollen 2hr p/vax given 10NOV97;large hives devel by 11PM on 10NOV97;MD called/seen on 11NOV97 who has done 2 series of allergy testing;biopsy of hives;all negative x/for a nickel allergy;pt eats eggs w/o problems;n,d				Y					N	11/10/1997	11/10/1997	0	2 series of allergy tests, biopsy of hive all negative;urine testing & blood test all negative;	PUB	PVT	Premarin	NONE	NONE	NONE~ ()~~~In patient	MI97163	1						1	Diarrhoea; Hypersensitivity; Laryngospasm; Nausea; Pyrexia; Urticaria	FLU3~PFIZER\WYETH~4978296~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105820	12/22/1997	MI	48.0	48		F	11/17/1997	pain/swelling @ inj site progressed to entire arm & shoulder;saw ENT pp on 6NOV97;motrin-ice PRN;				Y					Y	11/04/1997	11/05/1997	1	NONE	PUB	PUB	Ortho novo;Emetrix;	NONE	allergic to PCN	NONE~ ()~~~In patient	MI97162	1						1	Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4978196~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105822	12/22/1997	WI	69.0	69		F	12/13/1997	occasional sl itch @ lt upper arm site on 17th & 18th;late afternoon on the 18th dec noticed as a 2 1/2 hot, red area;7AM on the 19th a red area was 3 1/4;seen in ER;				Y					Y	10/17/1997	10/18/1997	1	NONE	PVT	UNK		NONE		~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~7+~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0105826	12/22/1997	MI	66.0	66		F	11/19/1997	swelling in rt arm-1/2 wide but extending from area shot was given to below elbow;has been using cold 5min & on 5min off at intervals;									Y	11/18/1997	11/18/1997	0	NONE	PUB	PUB	NONE	NONE	NONE	NA~ ()~~~In patient	MI97165	1						1	Injection site oedema; Oedema peripheral; Vasodilatation	FLU3~PFIZER\WYETH~4978296~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~435958~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0105828	12/22/1997	MN	35.0	35		F	12/17/1997	rt arm painful & weakness when lifting or stretching arm;										10/15/1997	10/22/1997	7	NONE	PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Myalgia; Myasthenic syndrome	FLUX~UNKNOWN MANUFACTURER~4978186~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0105829	12/22/1997	CA	50.0	50		F	12/12/1997	40mm erythema @ area of vax;									Y	10/28/1997	10/28/1997	0		PUB	UNK				~ ()~~~In patient		1						1	Rash	FLU3~CONNAUGHT LABORATORIES~7F81753~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105833	12/22/1997	MS	60.0	60		M	12/12/1997	about 2wk p/vax pt began to have sharp-knife like stabbing pains in upper rt arm;pt had pneumonia shot pains went away present but con occurring;c/o pain tetanus rt arm;										10/22/1997	11/06/1997	15	No test/labs/x-rays done	PUB	PUB	Mevacor, Verapamil	NONE-but is a heart pt	heart problems (had MI 10 yr ago) allergic PCN	NONE~ ()~~~In patient	MS97052	1						1	Pain	FLU3~MEDEVA PHARMA, LTD.~E20037KA~2~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0330D~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0105835	12/22/1997	NY	45.0			F	12/01/1997	devel severe local rxn below inj site (poss cellulitis) given ibuprofen for discomfort;										11/05/1997	11/05/1997	0		UNK	UNK				~ ()~~~In patient		1						1	Cellulitis; Injection site reaction; Pain	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105836	12/22/1997	NY	45.0			M	12/01/1997	extensive axillary lymph enlargement in arms where inj was given;given ibuprofen for discomfort;										11/05/1997	11/05/1997	0		UNK	UNK				~ ()~~~In patient		1						1	Lymphadenopathy; Nausea	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105837	12/22/1997	NY	50.0			F	12/01/1997	devel severe local rxn to inj swelling of arm;										11/05/1997	11/05/1997	0		UNK	UNK				~ ()~~~In patient		1						1	Injection site reaction; Oedema peripheral	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105846	12/23/1997	MI	67.0			M	12/01/1997	exp flu like sx w/ heavy cough; cough was described as an explosion w/in the body disrupting the nl function.  pt stated that as result of coughing, he exp degradation of sight,bleeding into the ear;as result of bleeding, lost hearing				Y				Y						PVT	OTH	unk;	none;		~ ()~~~In patient	897338015L	1						1	Cough; Deafness; Ear disorder; Haemorrhage; Influenza; Visual disturbance	FLU3~PFIZER\WYETH~~3~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0105847	12/23/1997	MI	68.0			M	12/01/1997	devel bout of coughing described as an explosion w/in the body disrupting the nl function. exp degradation of sight as a result of coughing; prior to oct 04, he only required reading glasses;				Y				Y	N	10/04/1997				PVT	OTH	unk;	none;		exp flu like sx and coughing following vax;degradation of sight, hearing loss;~ ()~~~In patient	897338016L	1						1	Cough; Visual disturbance	FLU3~PFIZER\WYETH~~4~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0105857	12/23/1997	UT	10.0	10		M		pain and swelling in lt hand 1 day after getting shot, lasted 5 days then devel pain and swelling in lt foot which persisted for 1month; foot cold;								Y	N	11/03/1997	11/04/1997	1	CBC and sed rate nl; doppler flow study abnl;	PVT	PVT			ADHD on Ritalin	~ ()~~~In patient		1						1	Hypertonia; Laboratory test abnormal; Oedema peripheral; Pain; Peripheral vascular disorder	FLU3~PFIZER\WYETH~4178150~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0105858	12/23/1997	KY	51.0			M	12/18/1997	onset was day after flus shot; inc dizziness, inc weakness, headache, diplopia; pt was dx w/ esophageal cancer w/brain mets while in hospital;					Y	3			N					MIL	MIL	motrin	none known	arthritis, hernia	~ ()~~~In patient		1						1	Asthenia; Delirium; Diplopia; Dizziness; Headache; Neoplasm malignant; Oesophagitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0106295	12/23/1997	NJ	68.0	68		F	12/10/1997	pt recv vax 29SEP97 & 2 days p/vax 1OCT97 pt exp gen aching-type pain in both knees, going down legs to feet;									U	09/29/1997	10/03/1997	4		PVT	PVT					97027457	1						1	Arthralgia; Myalgia	FLU3~MEDEVA PHARMA, LTD.~3327GA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~SMITHKLINE BEECHAM~539B6~1~IM~LA~HEP A (HAVRIX)~1|OPV~PFIZER\WYETH~445626~1~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~1|TD~CONNAUGHT LABORATORIES~7E91672~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0105868	12/24/1997	GA	42.0	42		M	11/07/1997	4NOV97 pt devel visual disturbances followed w/in a couple of hr by lt facial paralysis;pt also devel some weakness lt arm & lt leg;pt was hosp 4NOV97 & discharged 6NOV97 w/illness unresolved;dx of bell's palsy was given;					Y	2			U	10/29/1997	11/04/1997	6	NONE available	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	GA97141	1						1	Facial palsy; Myasthenic syndrome; Visual disturbance	FLU3~CONNAUGHT LABORATORIES~7F81791~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0105876	12/24/1997	GA	23.0	23		F	11/21/1997	hives began 5PM 6NOV97 (>24hr p/vax) & by 9:30 had spread to arms, chest, legs & neck;went to ER given adrenalin & IV;later was able to breath better;seen by MD 7NOV97;sl itching;				Y					Y	11/05/1997	11/06/1997	1		PUB	UNK	Depo provera;Nyquil	roughness in throat began in AM 5NOV97	PCN	~ ()~~~In patient	GA97143	1						1	Dyspnoea; Pruritus; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E20037KB~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0105877	12/24/1997	GA	54.0	54		F	10/22/1997	around 6PM 21OCT97 noticed arm getting sore;this morning arm very sore down to the elbow & up to shoulder joint;red area @ inj site about fifty cent in size & red blotches around area on forearm;				Y					Y	10/21/1997	10/21/1997	0	NONE	PUB	PUB	prempro	NONE	sulfa	~ ()~~~In patient	GA97135	1						1	Injection site hypersensitivity; Myalgia; Rash maculo-papular	FLU3~MEDEVA PHARMA, LTD.~E3297GB~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0994E~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0105878	12/24/1997	GA	57.0	56		F	10/22/1997	21OCT97 when pt got up noticed red area in shot area about fifty cent piece in size;today is approx 10cm in size & very red & hot to touch;went to MD was seen;				Y					Y	10/20/1997	10/21/1997	1	NONE	PUB	PUB	eye drops for glaucoma;cordizem;nasal spray	NONE	flu & pneumonia inj given in same arm d/t breast CA yrs ago	~ ()~~~In patient	GA97134	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3297GB~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0994E~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0105879	12/24/1997	GA	70.0	70		F	10/22/1997	lt arm was swollen from site of inj down to wrist;about size of an eggplant;accompanied by extreme pain;T101;				Y					Y	10/08/1997	10/08/1997	0	no lab work done	PUB	PUB	coumadine	NONE	NONE	NONE~ ()~~~In patient	GA97140	1						1	Injection site mass; Injection site oedema; Injection site pain; Oedema peripheral; Pain; Pyrexia; Skin nodule	FLU3~CONNAUGHT LABORATORIES~7F81747~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~436276~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0105880	12/24/1997	GA	41.0	41		F	10/16/1997	site of both inj started to itch;almost immed;by that noc both sites reddened, hot, painful, indurated;both arms more painful & warmer the next day;By Sunday itchy;16OCT flu site remains obviously darkened than surrounding site;									Y	10/02/1997	10/02/1997	0	NA	PUB	OTH	Sacol, lipitor, vitamins	NONE	ulcerative celitis, hyperlipidemia;	NA~ ()~~~In patient	GA97139	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Myalgia; Pruritus; Skin discolouration; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81747~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~436276~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0105881	12/24/1997	GA	43.0	43		M	10/22/1997	20min p/vax severe h/a devel began sweating-palms were red & sweaty had metal taste in mouth-took ASA for h/a;h/a lasted 5 days-OK now;									Y	10/22/1997	10/22/1997	0	NONE	PUB	PUB	ritalin	NONE	NONE	NONE~ ()~~~In patient	GA97136	1						1	Conjunctivitis; Dysgeusia; Headache; Hyperhidrosis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81832~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105882	12/24/1997	GA	26.0	26		F	10/09/1997	pt recv vax approx 2:30 on 2OCT97 during employee flu vax day @ 3PM pt c/o redness @ site of inj & c/o pain from site up into side of neck & face;given DPH & EPI;									Y	10/02/1997	10/02/1997	0	NONE	OTH	PUB	zyrtec for allergy;allergy shots weekly thru PMD;	NONE	allergic cat scan, dye, PCN, pollen, molds & ragwood;	NONE~ ()~~~In patient	GA97137	1						1	Injection site hypersensitivity; Injection site pain; Neck pain; Pain	FLU3~CONNAUGHT LABORATORIES~7F81747~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105883	12/24/1997	GA	25.0	25		F	10/09/1997	pt recv ax & 6 days p/vax pt had a local rxn;vax given 2OCT97 & pt states about hr p/vax had itching, rash, redness, swelling, & pain @ site rt arm lasted x 24hr & left knot;									Y	10/02/1997	10/02/1997	0	NONE	OTH	PUB	Slowbid;albuterol;asthmacort inhalers	NONE	allergies to trees, grass, dust mites & ragweed;	NONE~ ()~~~In patient	GA97138	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Injection site reaction; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81747~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105870	12/26/1997	NH	76.0	76		F	11/13/1997	pt has acquired GBS since recv flu shot;				Y	Y	4			N	10/17/1997	11/03/1997	17	LP which supported dx;	OTH	OTH	Zantac, zestril	NONE	NONE	~ ()~~~In patient	NH9730	1						1	Asthenia; CSF test abnormal; Guillain-Barre syndrome; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~7F81854~4~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~442521~1~IM A~~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0105920	12/26/1997	TX	43.0	43		F	12/08/1997	16OCT97 pt called & reported flu inj site from yesterday was swollen, red, & itching;pt called PMD who said could take flu vax again in future if sx did not worsen & they did not;									Y	10/15/1997	10/16/1997	1	NONE	UNK	OTH	NONE	NONE	fibromyalgia	~ ()~~~In patient	TX97163	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4978167~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105921	12/26/1997	HI	46.0	46		F	12/18/1997	15min post vax pt lt deltoid pain down lt arm to hand x 1 1/2 day the aching intermittently diff lt arm until present;weakness lt arm;unable to raise lt arm above head w/o discomfort;seen by MD x2;									N	11/12/1997	11/12/1997	0		MIL	PVT	NONE	NONE	PCN/vibramycin	NONE~ ()~~~In patient		1						1	Hypokinesia; Myalgia; Myasthenic syndrome; Pain	FLU3~CONNAUGHT LABORATORIES~7F81819~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105890	12/29/1997	MA	89.0	88		U	11/13/1997	pt devel urticaria & itching on body was given DPH po;				Y					Y	09/24/1997	09/25/1997	1		PUB	PUB	Aldomet;APAP	NONE	HTN	~ ()~~~In patient	MA9745	1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81793~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0105897	12/29/1997	MD	47.0	47		F	11/24/1997	pain @ site lt arm-inc pain over 3 days w/axillary, shoulder & neck pain over following wk called PMD 20NOV97;employee states flu shot acted as catalyst for pain										11/13/1997	11/13/1997	0		PUB	PUB	unk	unk	employee states 20yr neck history (injury 1976)	unk~ ()~~~In patient	MD97017	1						1	Injection site pain; Lymphadenopathy; Neck pain	FLU3~MEDEVA PHARMA, LTD.~E3287GH~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0105928	12/29/1997	MA	38.0	38		F	10/14/1997	pt recv vax & noted pain @ site immed;a half hr p/inj noted pain radiating up the arm to scapula & neck;cold pack applied;small amt of swelling noted @ inj site;250PM BP 110/70, P80, R16;4PM redness & induration @ inj site;some tingling										10/14/1997	10/14/1997	0		UNK	PUB	NONE	NONE	environmental allergies ie dust, dander, mold	~ ()~~~In patient	MA9744	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Neck pain; Pain; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E3287GH~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0105929	12/29/1997	MA	32.0	32		F	10/17/1997	pain radiating from site of inj down arm & into back/shoulder blade area;tingling & numbness radiating from site of inj down arm;all sx lasted 2-3 days;									Y	10/14/1997	10/14/1997	0	NA	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MA9742	1						1	Back pain; Injection site pain; Pain; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~3287GH~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0105930	12/29/1997	MA	43.0	43		M	10/27/1997	local swelling elbow to shoulder-pink, hot used ice;low grade fever;out of work x 1 day;tender;resolved 24-30hr later;pt states had pneumonia shot last year & hand no rxn;									Y	10/14/1997	10/14/1997	0	NONE	PUB	PUB		NONE	had triple bipass 95;	~ ()~~~In patient	MA9741	1						1	Injection site hypersensitivity; Injection site oedema; Pain; Pyrexia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~3287GH~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~099E5~2~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0105931	12/29/1997	MA	42.0	42		M	10/16/1997	pt reported lt arm was swollen & warm to touch by 4PM day of vax;pt used ice pack & Ibuprofen @ home for pain w/no improvement;upper third of lt arm red, swollen;pt states like flu sx;erythema extended to chest;										10/14/1997	10/14/1997	0	NONE	UNK	PUB	NONE	NONE	NONE-pt does work w/vaccines;	~ ()~~~In patient	MA9740	1						1	Influenza; Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Pain; Rash; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~3287GH~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0995E~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0105932	12/29/1997	MA	30.0	30		M		17OCT97 pt report a large site specific rxn 6-7 diameter swelling, erythema to rt arm;noted enlarged nodes (axillary) Tuesday evening, fever 102.5 on Wednesday relieved by APAP;low grade fever on Thursday;has had joint pain, achiness x 2d;										10/14/1997	10/15/1997	1		OTH	PUB	NONE	NONE	NONE	~ ()~~~In patient	MA9739	1						1	Arthralgia; Injection site hypersensitivity; Injection site oedema; Lymphadenopathy; Myalgia; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~328GH~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0995E~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0105934	12/29/1997	MA	27.0	27		F	10/14/1997	pain radiating down rt arm into hand & fingers, started 10min p/vax;also tingling & numbness;cold pack encouraged movement of rt arm;when arm rotated, pain inc;20OCt c/o tingling & numbness in fingers;minimal swelling @ site;hot;										10/14/1997	10/14/1997	0		PVT	UNK		NONE	poss allergy to coedine	~ ()~~~In patient	MA9743	1						1	Injection site oedema; Pain; Paraesthesia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3287GH~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~MASS. PUB HLTH BIOL LAB~TD62~UNK~IM~LA~TD ADSORBED (TDVAX)~1	USA		Influenza
0105910	12/30/1997	PA	71.0	71		F	12/08/1997	24 days p/vax pt devel ataxia & tingling in legs;dx of transverse myelitis made & pt was hosp;					Y			Y	N	10/24/1997	11/19/1997	26		PVT	PVT	Prinvil;Estrace;ASA	unk		~ ()~~~In patient	897343012L	1						1	Atrioventricular block; Coordination abnormal; Myelitis; Paraesthesia; Paraplegia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0105939	01/02/1998	MN	53.0	53		F	12/08/1997	vax area 6-7mm bright red, hot, swollen  w/less red area 6mm wide w/white circle around;entire area hard & swollen x 7-9 days w/center turning purple & discoloration still notable 8DEC97;painful area along femoral vein;enlarged node lt groi			Y							11/17/1997	11/17/1997	0		UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Lymphadenopathy; Pain; Skin discolouration; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~4978140~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0105944	01/02/1998	MD	6.0	6		M	12/24/1997	pt devel urticarial rxn approx 5min post vax;				Y					Y	12/02/1997	12/02/1997	0	NONE	PVT	PVT	NONE			~ ()~~~In patient		1						1	Urticaria	FLU3~PFIZER\WYETH~4978202~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105945	01/02/1998	CA	68.0	68		M	12/15/1997	27OCT97 pt recv vax & several hr later-local soreness in rt arm & shoulder;5NOV97 neck shoulder, back pain;17NOV97 pain in rt shoulder & neck, T100, nausea, diarrhea;dx serum sickness rxn;				Y					N	10/27/1997	11/05/1997	9	9DEC97 lyme titer neg;2DEC97 serum & PEP neg;4DEC97 anti nuclear antibody neg;RA latex neg;chem 27 WNL x/albuming 3.6;uric acid 3.1;CBC WNL x/sl anemia (has hx), sed rate 91, PSA nl;stool neg;PA-chest WNL;UA WNL;	PUB	PUB	Lodine	unknown	sl anemia, knee injury	NONE~ ()~~~In patient	CA970118	1						1	Back pain; Diarrhoea; Injection site pain; Laboratory test abnormal; Nausea; Neck pain; Pyrexia; Serum sickness; Back pain; Diarrhoea; Hyperhidrosis; Nausea; Neck pain; Pyrexia; Red blood cell sedimentation rate increased; Serum sickness	FLU3~CONNAUGHT LABORATORIES~7F81841~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~7F91700~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~7F81871~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|TD~CONNAUGHT LABORATORIES~7F91700~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0105947	01/02/1998	TX	37.0	37		M	12/01/1997	macular rash, lymphadenopathy-neck, axillary;decadron 8mg IM;									Y	11/06/1997	11/09/1997	3		OTH	OTH	Albuterol;Terbutaline	NONE	asthma	~ ()~~~In patient		1						1	Lymphadenopathy; Rash maculo-papular	FLU3~MEDEVA PHARMA, LTD.~3367HC~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0105948	01/02/1998	MA	59.0	59		F	12/14/1997	body aches, next day sl temp, immed p/vax diff breathing (also sl);									Y	10/29/1997	10/29/1997	0	NONE	PUB	UNK	Estrace;Zestril	NONE	allergy to amide anesthetics;borderline high blood pressure, enlarged heart;	NONE~ ()~~~In patient	MA9746	1						1	Dyspnoea; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81793~4~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0993E~2~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0105949	01/02/1998	MS	75.0	75		F	10/16/1997	1120AM pain rt arm w/in 1hr p/getting vax;swelling started during noc;frontal h/a this AM & now;rt upper arm red edematous form shoulder to approx 1 1/2 above elbow;									Y	10/15/1997	10/15/1997	0		PUB	UNK	aleve;APAP	NONE	HTN, arthritis	NONE~ ()~~~In patient	MS97055	1						1	Injection site hypersensitivity; Injection site oedema; Oedema; Pain	FLU3~MEDEVA PHARMA, LTD.~20017HC~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~421214~2~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0105951	01/02/1998	OR	47.0	47		M	10/20/1997	approx 2 days p/vax pt noted redness & swelling @ inj site 3 inches in diameter;area hot to touch;hot packed, didn't go to MD; resolved in 2 days;4 days p/inj;									Y	10/13/1997	10/15/1997	2		UNK	UNK	NONE			~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4978146~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105952	01/02/1998	OR	59.0	59		F	10/20/1997	approx 4min p/vax coughing & tightness in chest began;pale became flushed, felt hot;went to MD directly waited until 3:00 to see MD;				Y					Y	10/13/1997	10/13/1997	0		OTH	UNK	NONE	ongoing chronic resp condition	ongoing chronic resp condition	~ ()~~~In patient		1						1	Chest pain; Cough; Vasodilatation	FLU3~PFIZER\WYETH~4978146~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0105940	01/05/1998	CT	39.0	39		M	12/26/1997	optic neuritis 6 days post vax;				Y				Y	U	11/13/1997	11/18/1997	5		OTH	UNK	Zoloft	NONE	NONE	pt exp optic neuritis @ 38yr old;~ ()~~~In patient		1						1	Optic neuritis	FLU3~CONNAUGHT LABORATORIES~7F81863~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0105964	01/05/1998	OH	41.0	41		F	11/10/1997	pt recv vax & states arm was very sore from inj could hardly drive home;no redness on arm states whole body ached & had diarrhea or a couple of days;still can't sleep on that side & uses a pillow to prop it up when lays on the opposite side									N	10/29/1997	10/29/1997	0		OTH	PUB	NONE	NONE	some airborn allergies, no other medical conditions	~ ()~~~In patient	OH97098	1						1	Diarrhoea; Insomnia; Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~7F81917~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105965	01/05/1998	OH	73.0	73		M	12/03/1997	2 days p/vax pt saw sl bruising around inj site of rt area & discomfort in arm;pt states bruises easily;bruising /soreness lasted about 2 wk;28NOV pt noticed large bruised area (2x2.5) on rt arm inner deltoid area;yellowish edges, purple									N	10/27/1997	10/29/1997	2	NA	PUB	PUB	Zocor, amitripline;Intal, Cardizem, Beclorent, Sererent, Nitro state	NONE	heart problems;cataract surgery;bruises easily;	~ ()~~~In patient	OH97099	1						1	Ecchymosis; Myalgia; Pain; Skin discolouration	FLU3~CONNAUGHT LABORATORIES~7F81884~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105970	01/05/1998	MA	76.0	76		F	12/01/1997	pt states began exp pain & swelling of rt upper arm down to elbow the evening of the day recv vax;states arm cont to be weak & has difficulty lifting;									Y	10/23/1997	10/23/1997	0		PUB	PUB				NONE~ ()~~~In patient	MA9747	1						1	Injection site oedema; Injection site pain; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~7F81793~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105971	01/05/1998	MI	36.0			F	12/19/1997	2inch red, hot, firm circle around inj site;											10/01/1997		NONE	UNK	UNK			NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105972	01/05/1998		49.0			F	12/18/1997	pt recv vax 1PM & 3AM woke w/feeling of throat closing w/severe shooting pains going up neck & down rt arm;flu like sx started;unusual effect was sharp pain in neck & arm;had chills & lost voice 3 days;entire process took 10 days;											10/23/1997			UNK	UNK				~ ()~~~In patient		1						1	Chills; Influenza; Laryngitis; Laryngospasm; Neck pain; Pain	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105910	01/06/1998	PA	71.0	71		F		transverse myelitis w/paraplegia 19NOV97;								Y		10/24/1997	11/19/1997	26		UNK	UNK			HTN;hyperlipidemia;	pt exp intermittent heart block 13OCT97 w/flu vax;~ ()~~~In patient		1						2	Myelitis; Paraplegia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Disabling	Influenza
0106149	01/07/1998	ND	65.0	65		F	12/28/1997	GBS;severe back pain, leg cramps/fingers & toes numb;finally couldn't walk, facial paralysis, half smile;couldn't roll over w/o help;hard time swallowing couldn't close eyes;p/2mo in hosp had to learn to walk again but legs feel heavy;			Y	Y	Y	60	Y	Y	N	10/04/1994				PVT	PVT	Glynaise;Lotensin	newly dx diabetes;hypertension, hiatal hernia, glaucoma	newly dx diabetes, HTN, hiatal hernia, glaucoma;	~ ()~~~In patient		1						1	Back pain; Dysphagia; Facial palsy; Guillain-Barre syndrome; Hypokinesia; Muscle spasms; Myasthenic syndrome; Paraesthesia	FLU3~PFIZER\WYETH~4948108~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~378977~UNK~~RA~PNEUMO (PNU-IMUNE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0106152	01/07/1998	WI	63.0	63		M	12/04/1997	pt recv vax @ work place a/2:15;did not report any s/s of feeling ill either before or p/inj;lt for break 330PM & had MI during break;	Y	11/06/1997							N	11/06/1997	11/06/1997	0		PUB	UNK				~ ()~~~In patient		1						1	Myocardial infarction	FLU3~PFIZER\WYETH~4978172~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0106154	01/07/1998	RI	91.0	90		F		muscles aches;CPK-1400;EMG myopathy;muscle biopsy pending;rx w/steroids;					Y	2			Y	10/07/1997	10/10/1997	3		PVT	UNK		NONE	HTN-varicose vein-arthritis-LFT's inc;	NONE~ ()~~~In patient		1						1	Blood creatine phosphokinase increased; Myalgia; Myopathy	FLU3~CONNAUGHT LABORATORIES~7F81748~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0106166	01/07/1998	MN	39.0	39		F	01/04/1998	pt recv vax & exp burning sensation in arm, swelled, itched, flu like sx x 2 days;dizzy, lost balance worsening daily;				Y					Y	12/04/1997	12/04/1997	0		OTH	OTH	vits, ranitidine, paxil	none		~ ()~~~In patient		1						1	Coordination abnormal; Dizziness; Influenza; Myalgia; Oedema peripheral; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0106170	01/07/1998	TX	56.0	56		F	12/15/1997	pt presented to clinic w/pain & tenderness in arms & legs along w/edema that cont to spread to back & neck over next several wk;pt sent to MD neuro end of NOV;dx inflammation myositis secondary to adverse vax rxn;				Y					U	10/01/1997	10/27/1997	26		OTH	OTH	NONE			~ ()~~~In patient		1						1	Hypoaesthesia; Myositis; Oedema; Oedema peripheral; Pain	FLU3~CONNAUGHT LABORATORIES~6F81754~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0106173	01/07/1998	CA	4.0			F	12/12/1997	local redness, swelling, induration 4x7cm lt arm @ site of inj;				Y									NONE	UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0106177	01/07/1998	MD	32.0	32		M	12/17/1997	pt recv vax 9DEC97 130PM;11DEC97 in AM had sx of nasal congestion,h/a, productive cough was seen in ER x 2;tx expectorant sx lasted approx 1wk;				Y					Y	12/09/1997	12/11/1997	2	NONE	PVT	PVT	NONE	NONE	NONE	unk~ ()~~~In patient		1						1	Cough; Headache; Rhinitis	FLU3~PFIZER\WYETH~4978162~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~MERCK & CO. INC.~0454E~2~IM~LA~HEP B (RECOMBIVAX HB)~1	USA	Emergency room visit	Influenza
0106182	01/07/1998	MN	17.0	17		F	10/29/1997	dizzy, h/a, n/v, pain edema lt arm, achiness, malaise; (no edema or pain rt arm);				Y					Y	10/23/1997	10/23/1997	0		OTH	PVT	unk	NONE	NONE	~ ()~~~In patient		1						1	Dizziness; Headache; Malaise; Myalgia; Oedema peripheral; Pain; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81754~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~442522~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0106183	01/07/1998	MN	17.0	17		M	10/29/1997	blurry vision, dizziness, h/a, pain & edema of lt arm;gen aching/malaise;fever, nausea;				Y					Y	10/23/1997	10/23/1997	0		OTH	PVT	unk	NONE	NONE	~ ()~~~In patient		1						1	Amblyopia; Dizziness; Headache; Malaise; Nausea; Oedema peripheral; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81754~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~442522~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0106184	01/07/1998	MN	17.0	17		F	10/29/1997	eyes swollen, red, watering;edema & pain @ inj site, fever, gen aching/malaise, nausea, h/a;				Y					Y	10/23/1997	10/23/1997	0		OTH	PVT	unk	NONE	NONE	~ ()~~~In patient		1						1	Conjunctivitis; Headache; Injection site oedema; Lacrimal disorder; Malaise; Myalgia; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81754~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~442522~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0106185	01/07/1998	MN	17.0	17		F	10/29/1997	eyes swollen, red, watering;edema in face;pain & edema @ inj site;fever, gen achiness/malaise, nausea & h/a;				Y						10/23/1997	10/23/1997	0		OTH	PVT	unk	NONE	NONE	~ ()~~~In patient		1						1	Conjunctivitis; Headache; Injection site oedema; Malaise; Myalgia; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81754~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~442522~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0106186	01/07/1998	MN	26.0	26		F	10/29/1997	rt side from waist to head edematous extreme pain rt arm reports unable to move d/t pain;fever, n/v;contacted MD;				Y					Y	10/23/1997	10/23/1997	0		OTH	PVT	unk	NONE	NONE	~ ()~~~In patient		1						1	Oedema; Pain; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81754~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~442522~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0106187	01/07/1998	MN	17.0	17		F	10/29/1997	edema in face, pain, edema lt arm;fever n/v, gen aching/malaise, h/a;				Y					Y	10/23/1997	10/23/1997	0		OTH	PVT	unk	NONE	NONE	~ ()~~~In patient		1						1	Face oedema; Headache; Malaise; Myalgia; Oedema peripheral; Pain; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81754~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~442522~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0106189	01/07/1998	MN	53.0	53		F	11/06/1997	arm became swollen from shoulder to elbow, bright red & painful 5 days p/shot;took med recommended by PA;resolved w/o problems;				Y					Y	10/27/1997	10/31/1997	4	NONE	PUB	PUB	NONE	NONE	allergies-natural rubbers, latex	~ ()~~~In patient	MN97055	1						1	Oedema peripheral; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4978155~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~7C91574~4~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0106190	01/07/1998	MN	38.0	38		F	11/10/1997	pt recv vax & 1wk later started feeling lightheaded, dizzy, nauseated & seeing white spot Tuesday AM/PM, Wednesday AM/PM saw MD 9NOV97 placed on muscle relaxant for neck stiffness-tingling arms & fingers 1 days;feeling shaky/hot;				Y					U	10/28/1997	11/05/1997	8	if not better by TUesday/Wednesday 12OCT will be scheduled for CATSCAN;	PUB	PUB			hx of tight shoulder/back w/PT intervention 6mo ago;working long hr & alot of stress @ job;	~ ()~~~In patient	MN97056	1						1	Dizziness; Headache; Hypertonia; Nausea; Nuchal rigidity; Pain; Paraesthesia; Tremor; Vasodilatation; Visual disturbance	FLU3~PFIZER\WYETH~4978168~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0106191	01/07/1998	MN	38.0			M	10/31/1997	pleurisy				Y					Y	10/24/1997	10/26/1997	2	CXR nl	PVT	PVT		unk	NONE	~ ()~~~In patient		1						1	Pleural disorder	FLU3~PFIZER\WYETH~4978205~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0106196	01/07/1998	MN	48.0	48		M	12/19/1997	1st day bloated stomach repeated burped, weakness, h/a;2nd day blurred vision, SOB, numbness of lips & tongue, slurred speech, erratic walk;				Y					Y	11/19/1997	11/19/1997	0	transient ishemic attack suspected but nos igns indicated;	PUB	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Amblyopia; Asthenia; Dyspnoea; Flatulence; Gait disturbance; Headache; Paraesthesia oral; Speech disorder	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~2~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|OPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, ORAL (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0106199	01/07/1998	CA	62.0	62		F		pt recv vax 3PM & 6PM mouth gum-cheeks felt as if blisters were trying to break through mucous membrane like had eaten red/hot pepper;7PM eyes became red felt had gravel under eye lids;9PM felt throat muscles getting tight-to ER;given DPH;				Y					Y	11/05/1997	11/05/1997	0	NONE	PVT	OTH		NONE	NONE	NONE~ ()~~~In patient		1						1	Conjunctivitis; Dry eye; Laryngospasm; Mucous membrane disorder; Rash	FLU3~CONNAUGHT LABORATORIES~7F81898~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0106202	01/07/1998	IL	19.0	19		F	12/06/1997	about 1/2hr p/vax devel severe pain in inj arm radiating to chest wall, also numbness of fingers, nausea, lightheadedness, pain involved entire arm, had very limited ROM;pt was treated w/Ibuprofen, chlorphenihamine & IV fluid;resolved 5hr				Y					Y	11/09/1997	11/09/1997	0		MIL	MIL	NONE	NONE	sulfa allergy	~ ()~~~In patient		1						1	Chest pain; Dizziness; Hypokinesia; Nausea; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4978177~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0106210	01/07/1998	PA	68.0	68		F	11/28/1997	pt reports a knot in arm @ the inj site rt arm that is still present 2DEC97;reports site is itchy during the day;the muscle is still sore upon movement & the site recently devel red blood blisters;									Y	10/15/1997	10/16/1997	1		PVT	PVT	Insulin	diabetes		pt reports prior rxn swollen & itchy from the day of vax;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Myalgia; Oedema; Pruritus	FLU3~PFIZER\WYETH~4978145~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0106222	01/07/1998	TN	34.0			F	12/29/1997	pt exp leg cramps since the vax in both legs & lt foot;spasms are in rt leg the most;pt woke up during the noc most of the time;pt has been taking physical therapy & hurt worse afterwards;									N					PVT	UNK	Dilitan, Neurontion, premarin, flornit;tracdon;			~ ()~~~In patient		1						1	Insomnia; Muscle spasms	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0106224	01/07/1998	MN	83.0	83		M	10/31/1997	pt recv vax 13OCT97 about 1wk later lt deltoid started aching;also has arthritis which causes aching;no redness, warmness, or hardness noted when came into have it checked;									U	10/13/1997	10/20/1997	7	NA	PUB	PUB	oral hypoglycemic pain	NONE	diabetes;arthritis	unk~ ()~~~In patient	MN97053	1						1	Injection site pain	FLU3~PFIZER\WYETH~4978168~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0106231	01/07/1998	MN	42.0	42		F		achiness over entire body on day of shot;residual achiness in knees & fingers;									N	11/06/1997	11/06/1997	0	NONE	PUB	OTH	unk	NONE	sulfa/nickel, amoxicillin	~ ()~~~In patient	MN97058	1						1	Myalgia	FLU3~PFIZER\WYETH~4978178~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0106232	01/07/1998	MN	35.0	35		F	11/13/1997	6NOV97 by 5PM pt had severe h/a; a little gen achiness but not much;h/a persisted until Friday & was not relieved by APAP until p/3 separate doses over 18hr;more achiness devel w/chills, low grade fever & nausea;no appetite;diarrhea;									Y	11/06/1997	11/06/1997	0	NONE	OTH	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MN97057	1						1	Anorexia; Diarrhoea; Headache; Myalgia; Nausea; Pyrexia	FLU3~PFIZER\WYETH~4978168~3~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0106233	01/07/1998	MN	36.0	36		F	10/29/1997	fever 102, n/v, gen aching/malaise, pain, edema lt arm;									Y	10/23/1997	10/23/1997	0		OTH	PVT	unk	NONE	nONE	~ ()~~~In patient		1						1	Malaise; Myalgia; Oedema peripheral; Pain; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81754~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~442522~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0106234	01/07/1998	MN	30.0	30		F	10/29/1997	fever elevated to 103, pain, swelling lt arm, n/v;gen aching/malaise, h/a;									Y	10/23/1997	10/23/1997	0		OTH	PVT	unk	NONE	NONE	~ ()~~~In patient		1						1	Headache; Malaise; Myalgia; Oedema peripheral; Pain; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81754~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~442522~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0106235	01/07/1998	MN	25.0	25		M	10/29/1997	swelling, edema @ inj site lt deltoid, swollen nodes in lt axilla, fever, n/v, gen aching/malaise;sx began w/in hr, cleared w/in 48hr;									Y	10/23/1997	10/24/1997	1		OTH	PVT	unk	NONE	NONE	~ ()~~~In patient		1						1	Injection site oedema; Lymphadenopathy; Malaise; Myalgia; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81754~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~442522~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0106236	01/07/1998	MN	65.0	65		M	10/29/1997	pain, swelling, tenderness lt arm, fever, gen aching/malaise, h/a;									Y	10/23/1997	10/23/1997	0		OTH	PVT	unk	NONE	NONE	~ ()~~~In patient		1						1	Headache; Malaise; Myalgia; Oedema peripheral; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81754~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~442522~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0106237	01/07/1998	MN	35.0	35		M	10/29/1997	pain, swelling, tenderness lt arm, fever, gen aching/malaise, h/a;									Y	10/23/1997	10/23/1997	0		OTH	PVT	unk	NONE	nONE	~ ()~~~In patient		1						1	Headache; Malaise; Myalgia; Oedema peripheral; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81754~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~442522~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0106238	01/07/1998	MN	16.0	16		F	10/29/1997	severe h/a, sore arm, general aching/malaise;									Y	10/23/1997	10/23/1997	0		OTH	PVT	unk	NONE	NONE	~ ()~~~In patient		1						1	Headache; Malaise; Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~7F81754~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~442522~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0106239	01/07/1998	MN	37.0	36		M	10/29/1997	c/o blurry vision like a film on eyes;n/v, fever, pain & edema @ rt deltoid inj site;									Y	10/23/1997	10/23/1997	0		OTH	PVT	unk	NONE	NONE	~ ()~~~In patient		1						1	Amblyopia; Injection site oedema; Injection site pain; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81754~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~442522~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0106248	01/07/1998	OH	11.0	11		F	12/17/1997	lt arm became red & painful around immun site;there was no streaking & the erythematous area was 4cm x 3cm lt arm was painful on movement;tx w/DPH & cold compresses;									Y	12/03/1997	12/04/1997	1	NONE	PUB	OTH	methylphenidate	NONE	ADHD	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Rash	FLUX~UNKNOWN MANUFACTURER~4978275~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~0928E~2~IM~~HEP B (NO BRAND NAME)~1	USA		Influenza
0106249	01/07/1998	MN	25.0	25		F	10/29/1997	pt  began w/in hr resolved w/in 48hr of inj swelling lt side of face, arm, lymph nodes, fever, n/v;gen aching/malaise;									Y	10/23/1997	10/23/1997	0		OTH	PVT	unk	NONE	NONE	~ ()~~~In patient		1						1	Face oedema; Lymphadenopathy; Malaise; Myalgia; Oedema peripheral; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81754~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~442522~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0106266	01/08/1998	CO	50.0	50		F	10/29/1997	flat,blotchy, red, tender rash entire upper 1/2 of lt arm;beginning am of 29OCT97;										10/27/1997	10/29/1997	2	NOEN	PUB	PUB	hormones-estrogen/progestines	NONE	allergic to codeine, has arthritis, uses HRT	~ ()~~~In patient	CO97059	1						1	Pain; Rash maculo-papular; Vasodilatation	FLU3~PFIZER\WYETH~4978172~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105945	01/09/1998	CA	68.0	68		M	12/15/1997	27OCT97 several hr later local soreness in rt arm & shoulder;persisted throughout illness;5NOV97 neck, shoulder back pain until placed on pred;17NOV97 rt shoulder & neck;T100, nausea, diarrhea;dx serum sickness;				Y					N	10/27/1997	10/27/1997	0	9DEC97 lyme titer negative;2DEC97 serum PEP negative;4DEC97 anti nuclear antibody neg;RA latex neg;chem 27 WNL x/albumin 3.6, uric acid 3.1;CBC WNL x/anemia(has hx);sed rate 91, PSA nl;UA WNL;PA CHEST WNL;stool neg;	PUB	PUB	lodine	NONE	sl anemia, knee injury	NONE~ ()~~~In patient	CA980004	1						2	Back pain; Diarrhoea; Injection site pain; Laboratory test abnormal; Nausea; Neck pain; Pyrexia; Serum sickness; Back pain; Diarrhoea; Hyperhidrosis; Nausea; Neck pain; Pyrexia; Red blood cell sedimentation rate increased; Serum sickness	FLU3~CONNAUGHT LABORATORIES~7F81841~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~7F91700~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~7F81871~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|TD~CONNAUGHT LABORATORIES~7F91700~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0106277	01/09/1998	TX	46.0	46		F	12/17/1997	aching body, could not get out of bed for a day & half;could not raise arm;									Y	12/10/1997	12/10/1997	0	NA	PVT	PVT		depression, chemical allergies	other allergies, allergy to sulfa;	~ ()~~~In patient	TX97169	1						1	Hypokinesia; Myalgia	FLU3~CONNAUGHT LABORATORIES~7F81803~5~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~448191~UNK~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0092612	01/12/1998	LA	67.0	67		F	01/06/1998	elevated BP, progressive paralysis of all four extremities, acute transverse myelitis, cardio-respiratory arrest, death;	Y		Y	Y	Y		Y	Y	N	10/21/1996	10/21/1996	0		OTH	PUB			HTN, hyperlipidemia	~ ()~~~In patient		1						3	Cardiac arrest; Hypertension; Myelitis; Paralysis	FLU3~PFIZER\WYETH~4968175~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~3|PPV~MERCK & CO. INC.~1626B~UNK~~~PNEUMO (PNEUMOVAX)~3	USA	Results in Death	Influenza
0103911	01/12/1998	CA	5.0	5		M	01/06/1998	swelling, redness, hot area @ site of inj;									Y	10/20/1997	10/22/1997	2		PVT	OTH	NONE			~ ()~~~In patient		1						2	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81820~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0106308	01/12/1998	MS	83.0	83		M	12/03/1997	pt exp worsening weakness x 2mo w/diff walking x2wk;pt exp joint stiffness;devel some numbness in hands & feet;pt noted to have flipped T waves in lateral chest leads;pt hosp;muscle weakness;GBS, ataxic;control dec;polyradiculoneuropathy;	Y				Y	13			N	10/20/1997			grip strength 80-85%;thininning of muscle bulk to first dorsal interosseous muscle;thyroid nl;CPK nl;sed rate 50;total white count 7,800 w/H&H 12.9 & 39.1;rheumatoid factor neg;EKG nonspecific ST changes plus LAD:	PUB	PUB				~ ()~~~In patient	MS97056	1						1	Adrenal insufficiency; Asthenia; Coordination abnormal; Guillain-Barre syndrome; Hypertonia; Myasthenic syndrome; Neuropathy; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E20037KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0106309	01/12/1998	WA	36.0	36		F	11/10/1997	pt rheumatoid arthritis was acting up & pt having trouble moving legs;29OCT97 weakness in proximal muscle grows & diff walking;1NOV intubated d/t resp failure & diff controlling secretions;quadriplegic 10% movement of one eye;			Y	Y	Y				N	10/20/1997	10/29/1997	9	neuro exam;spinal tap;acetacheline receptor antibody titer;EMG & nerve conduction;CBC;	PUB	PVT	Pred;Methotrexate;Indocin;Zaulfidine	unsubstantiated rpeort URI	rheumatoid arthritis x 5 yr;	NONE~ ()~~~In patient	WA971412	1						1	Apnoea; Arthritis; Condition aggravated; Facial palsy; Hypokinesia; Hypoxia; Myasthenic syndrome; Paralysis	FLU3~CONNAUGHT LABORATORIES~7F81841~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0106310	01/12/1998	WA	90.0	90		F	10/27/1995	45min post inj devel h/a & confusion found shortly thereafter to have had in intracranial hemorrhage;				Y	Y	6		Y	N	10/18/1995	10/18/1995	0	CT Scan & MRI-intracranial hemorrhage;	PVT	UNK	Ibuprofen	NONE	NONE	~ ()~~~In patient	WA971413	1						1	Cerebral haemorrhage; Confusional state; Headache	FLU3~PFIZER\WYETH~4958126~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0106313	01/12/1998	OH	67.0	67		F	01/09/1998	1 day of vax feverish-pain @ inj site, malaise, poor appetite, fever 102.6 cultured-no other organisms isolated;					Y	2			Y	09/29/1997	09/29/1997	0	WBC-nl	PVT	PVT		NONE	hypothyroid-IDDM	~ ()~~~In patient		1						1	Anorexia; Injection site pain; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81770~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~03290~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0106326	01/12/1998	CA	66.0	65		F	12/30/1997	sudden bilat hearing loss 9sensory neuro) dec to 55 dec;swelling of proximal rt index finger also noted could be r/t flu vax;									U	10/22/1997	11/24/1997	33	1st week of December bilat ear cleaning & audiometry testing referred to ENT	PVT	PUB	NONE	NONE	NONE	~ ()~~~In patient	CA980001	1						1	Deafness transitory; Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~7F81841~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0106328	01/12/1998	ID	45.0	45		F	12/12/1997	persistent paresthesias lt shoulder & forearm x 7-9 days;rx NSAID, soma;				Y					U	12/03/1997	12/03/1997	0	NONE	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient	ID97058	1						1	Paraesthesia	FLU3~PFIZER\WYETH~4978208~6~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0106329	01/12/1998	ID	38.0	38		F	12/08/1997	pt recv vax & 1hr later arm began itching then itching all over;took DPH;next day c/o h/a, chills, nausea, malaise x 2 1/2 days then tingling began in fingers, toes, legs, face, C x 5wk;MD put pt on pred;throat began to swell;cont tingling				Y					U	10/23/1997	10/23/1997	0	unk	PUB	PUB	NONE	fibromyalgia x 1 1/2yr;asthma x 3yr	sulfa, PNC, codeine, Ibuprophen, pred	~ ()~~~In patient	ID97059	1						1	Chills; Headache; Laryngospasm; Malaise; Nausea; Pruritus	FLU3~PFIZER\WYETH~4978202~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0106334	01/12/1998	OK	55.0	55		M	10/24/1997	pt devel severe h/a 2hr p/vax;APAP wont help;c/o muscle aches in lower back 1hr p/vax;				Y					U	10/23/1997	10/23/1997	0		PUB	PUB	Phenzain;Diazepam	NONE	NONE	NONE~ ()~~~In patient	OK9746	1						1	Back pain; Headache; Myalgia	FLU3~MEDEVA PHARMA, LTD.~E3277GA]~7+~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0106336	01/12/1998	WY	19.0	18		M	01/06/1998	pt recv vax & devel chills, noc sweats, body aching, lt arm pit edema, 2 red streaks from lt deltoid to arm pit & tightness in chest when deep breathing;6JAN98 seen @ clinic;augmentin prescribed x 10 days;pt states feel better today 6JAN98				Y					U	01/05/1998	01/05/1998	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Chest pain; Chills; Hyperhidrosis; Lymphadenopathy; Myalgia; Skin striae; Chest pain; Chills; Hyperhidrosis; Lymphadenopathy; Pruritus; Skin striae	FLU3~PFIZER\WYETH~4978213~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~7E91672~5~IM~RA~TD ADSORBED (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4978213~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~2|TD~CONNAUGHT LABORATORIES~7E91672~1~IM~RA~TD ADSORBED (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0106346	01/12/1998	MA	47.0	47		U		fever, chills, cough, dizziness, upset stomach, site of inj sore, red, swollen;									Y	11/19/1997	11/20/1997	1		OTH	OTH			asthma, high BP	~ ()~~~In patient		1						1	Cough; Dizziness; Dyspepsia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0106359	01/12/1998	OH	44.0	44		M	12/23/1997	1/2hr p/vax c/o vertigo, tightness in throat & chest;T104 by 4AM 31OCT97;pt had taste of alcohol in throat & vertigo immed post inj;did not seek med help;pt did not tell nurse felt dizzy;c/o tight throat;next AM all sx gone;									Y	10/31/1997	10/31/1997	0	NONE	PUB	PUB	unk	NA	NONE	unk~ ()~~~In patient	OH97104	1						1	Chest pain; Dizziness; Dysgeusia; Laryngospasm; Pyrexia; Vertigo	FLU3~CONNAUGHT LABORATORIES~7F81917~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0106361	01/12/1998	WI	75.0	75		F	12/16/1997	pt recv vax & began exp pain in rt arm @ site of inj;pain is persistent & now is in hips, legs so that pt has problems walking, sitting or rolling over in bed;once pt is walking or moving pain is not as bad;									U	11/01/1997				UNK	PVT	BP meds	NONE	HTN	~ ()~~~In patient		1						1	Hypokinesia; Injection site pain; Pain; Hypokinesia; Pain; Gait disturbance; Hypokinesia; Injection site pain; Insomnia; Pain	FLU3~PFIZER\WYETH~4978172~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~4444075~1~IM~LA~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~4978172~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~444075~1~IM~LA~PNEUMO (PNU-IMUNE)~2|FLU3~PFIZER\WYETH~4978172~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~3|PPV~PFIZER\WYETH~444075~1~IM~LA~PNEUMO (PNU-IMUNE)~3	USA		Influenza
0106363	01/12/1998	WA	46.0	46		F		pt recv vax & about 2:30 next day pt noted white circle around the inj site that morning;pt had swelling of hands neck & arms;advised to get DPH & use q 4hr;describes chills & ?fever;									Y	11/24/1997	11/25/1997	1		PUB	PUB		injury to rt hand 1mo prior had swelling nox-ray done		~ ()~~~In patient	WA971414	1						1	Injection site hypersensitivity; Oedema; Oedema peripheral; Pyrexia	FLU3~PFIZER\WYETH~4978174~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0105745	01/13/1998	MD	77.0	77		M	01/12/1998	pt recv vax & w/in 24hr post vax pt found dead;autopsy report listed death d/t severe CAD;	Y	11/22/1997							N	11/21/1997	11/22/1997	1	NONE	PUB	OTH		prophylaxis	NONE	~ ()~~~In patient	MPI971119	1						2	Unevaluable event	FLU3~MEDEVA PHARMA, LTD.~E20017~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Results in Death	Influenza
0106323	01/13/1998	OH	44.0	44		M	01/07/1998	quadriplegia & 100% vent assisted;pt too weakened to cont w/chemotherapy;prognosis is less than 2mo;	Y		Y	Y	Y		Y	Y	N	11/02/1997	11/06/1997	4	several CT scans, MRI, blood work, etc;refused to test for GBS;	OTH	OTH	Dilantin, decadron 9started in JUL post op brain surg)	glioblastoma	before dx glioblasma, excellent health before & ater;	~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome; Hypoxia; Paralysis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0106369	01/13/1998	CA	33.0	33		F	12/15/1997	anaphylaxis-pt was @ hosp later in afternoon & felt ill, nauseous, had rash & dyspnea;went to ER & was treated by their MD for 4hr w/complete recovery;				Y					Y	10/28/1997	10/28/1997	0	NONE	OTH	PUB	unk	NONE	self reported hx of ulcers	~ ()~~~In patient		1						1	Dyspnoea; Malaise; Nausea; Rash	FLU3~CONNAUGHT LABORATORIES~7F81816~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0106370	01/13/1998	IL	58.0	58		F	12/16/1997	pt stated had no sx for 24hr p/shot;6PM following day began to have spasms in shoulder & neck & could not lift head;went to MD day 2 p/shot 7 was given muscle relaxants which did not help;blood clot;				Y					U	11/10/1997	11/11/1997	1	ultrasound of neck & arm NOV97	PUB	PUB		NONE	NIDDM;HTN;obesity	NONE~ ()~~~In patient	IL97113	1						1	Hypertonia; Hypokinesia; Myasthenic syndrome; Thrombosis	FLU3~MEDEVA PHARMA, LTD.~E33276A~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0106381	01/13/1998	SD	57.0	57		M	11/20/1997	2 inches below inj site developed a demarcated area of erythema;pt was placed on pred & DPH & marked improvement noted 3rd day;				Y					Y	10/07/1997	10/08/1997	1	NA	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~4978168~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0106390	01/13/1998	MA	41.0	41		F	10/22/1997	rxn to pneumonia vax;w/in 4hr of inj rt arm red, hot, swollen to elbow area;swollen under arm pit & down to elbow area rt hand swollen in AM;hot & throbbing;most acute sx lasted for 24hr post vax;									Y	10/16/1997	10/16/1997	0		UNK	UNK		NONE	had pneumonia 2X last yr vax recommended by MD	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Lymphadenopathy; Oedema peripheral; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81793~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0993E~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0106396	01/14/1998	MI	7.0	7		F	01/06/1998	total all body breakout p/2nd dose of vax required pedipred to control p/10 days of breakout w/only antihistamine;									Y	11/20/1997				PVT	PVT				pt exp all body breakouts p/dose 1 flu vax;~ ()~~~In patient		1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0106398	01/14/1998	PA	69.0	69		F	11/25/1997	inability to ambulate w/o assistance;inability to process thoughts or speak coherently;									Y	10/16/1997	10/17/1997	1	MRI-no abn	PVT	PVT		NONE	NA	NA~ ()~~~In patient		1						1	Hypokinesia; Thinking abnormal	FLU3~CONNAUGHT LABORATORIES~7F81723~7+~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~443660~2~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0091284	01/15/1998	VA	36.0	36		F	12/03/1997	pt recv vax & reported facial itching 4hr post vax  & reported red welts the size of mosquito bites on face, arm, & trunk;duration of welts cont until 11OCT96;pt reports very few bumps remain;									Y	10/09/1996	10/09/1996	0		OTH	PVT	Oral contraceptives;OTC vitamins & calcium		Ibuporfen prev led to identical sx;	~ ()~~~In patient	CO6851	1						2	Pruritus; Rash maculo-papular; Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71229~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0091523	01/15/1998	WI	38.0	38		M	11/28/1997	pt devel asthmatic wheezing, red eyes & reported throat hurt, 4hr post vax tx w/inhaler given DPH in ER & sent home;				Y					Y	10/08/1996	10/08/1996	0		OTH	PVT		asthma		pt reports asthmatic rxn to flu vax given in 1976~ ()~~~In patient	CO6854	1						2	Asthma; Conjunctivitis; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~6F71288~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0091668	01/15/1998	RI	31.0	31		F	11/28/1997	pt recv vax & devel a large area of redness & swelling around the site of inj 8hr p/vax;itchiness was also noted;									Y	10/30/1996	10/30/1996	0		PVT	OTH			allergies to tetracyclines & augmetin	~ ()~~~In patient	CO6985	1						2	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~CONNAUGHT LABORATORIES~6F71266~2~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0091674	01/15/1998	RI	43.0	43		F	11/28/1997	pt devel a large area of localized redness & swelling around the site of inj 5hr p/vax;pt was reported to have recovered from this exp;									Y	10/30/1996	10/30/1996	0		PVT	OTH			endometrial, PCH	~ ()~~~In patient	CO6987	1						2	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~6F71266~3~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0091738	01/15/1998	RI	35.0	35		F	11/28/1997	pt devel large area of redness & swelling around the site of inj;8hr post vax;									Y	10/30/1996	10/30/1996	0		PVT	OTH				~ ()~~~In patient	CO6986	1						2	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~6F71266~3~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0091825	01/15/1998	RI	30.0	30		F	11/28/1997	pt devel a large band area of swelling, redness & itching 9hr post vax;									Y	10/30/1996	10/30/1996	0		PVT	OTH	Klonopin		asthma, environmental allergies;	~ ()~~~In patient	CO6988	1						2	Oedema; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71266~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0091858	01/15/1998	RI	61.0	61		F	11/28/1997	pt devel SOB, lightheadedness, weakness & a large area of redness the morning p/vax;current therapy consists of synthroid, prempro, ventolin & flonase;									Y	10/31/1996	11/10/1996	10		PVT	OTH	SYnthroid, Prempro;Ventolin, Flonase			~ ()~~~In patient	CO6989	1						2	Asthenia; Dizziness; Dyspnoea; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71266~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0091943	01/15/1998	IN	31.0	31		F	11/29/1997	pt devel pain in lt arm where shot was given;pt not evaluated by MD;the next day p/vax pt neck became stiff & sore;pt recovered;									Y	10/08/1996	10/09/1996	1		PUB	PUB				~ ()~~~In patient	CO6874	1						2	Injection site pain; Neck pain; Nuchal rigidity	FLU3~CONNAUGHT LABORATORIES~6F71223~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0091958	01/15/1998	RI	34.0	34		F	11/28/1997	pt devel a severe itchy rash covering the upper torso, neck & scalp the day p/vax;tx w/hydrocortisone & mycolog creams by local MD;				Y					Y	10/03/1996	11/01/1996	29		UNK	UNK			hayfever, eczema	~ ()~~~In patient	CO6990	1						2	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~6F71266~3~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0091961	01/15/1998	RI	38.0	38		F	11/28/1997	pt devel runny, itchy eyes, congestion, redness, swelling & itchiness @ the inj site 1hr p/vax;									Y	10/30/1996	10/30/1996	0		PVT	UNK			allergies to cats, dust, mites;tx w/allergy shots q 3 wk;	~ ()~~~In patient	CO6991	1						2	Conjunctivitis; Injection site hypersensitivity; Injection site oedema; Pruritus; Rhinitis	FLU3~CONNAUGHT LABORATORIES~6F71266~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0091970	01/15/1998	MO	52.0	52		M	12/03/1997	pt devel pimples @ site, then red bumps that progressed into blisters & scabbed over, initially in deltoid area;also one nodule on lt chest, red blister as well;company MD feels vax related because  occurred on same side of body as vax;				Y					Y	10/01/1996	10/04/1996	3		OTH	PVT	Seldane;Beconase		reported as allergic to molds & dust	~ ()~~~In patient	CO6868	1						2	Dermatitis bullous; Rash maculo-papular; Skin nodule	FLU3~CONNAUGHT LABORATORIES~6F71247~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0092057	01/15/1998	IN	71.0	71		M	11/28/1997	pt recv vax & devel induration @ inj site, chills, sweats, back pain;pt not evaluated by DM;									Y	10/11/1996	10/12/1996	1		PUB	PUB	Pepcid;eye drops;		ulcers, HTN, COPD, partial collapse of lt lung;	~ ()~~~In patient	CO6872	1						2	Back pain; Chills; Hyperhidrosis; Injection site mass	FLU3~CONNAUGHT LABORATORIES~6F71223~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0092120	01/15/1998	RI	57.0	56		F	11/28/1997	pt recv vax & devel aches & chills 48hr p/vax;also w/in 8hr of vax the site became red, hot & sore;over the course of 1wk site became a large (1x2inch) red, swollen, painful area;2wk post vax site was darker red/bruised in appearance;									Y	10/03/1996	10/30/1996	27		PVT	UNK			HTN, allergies (molds, dust, plants, CA)	~ ()~~~In patient	CO6984	1						2	Chills; Ecchymosis; Injection site hypersensitivity; Injection site pain; Myalgia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71266~3~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0092161	01/15/1998	NE	32.0	32		F	01/12/1998	pt recv vax 25SEP96 & pt exp a raised, red, inflamed, painful rxn, 5x4in size @ the inj site 5hr p/vax;									U	09/25/1996	09/25/1996	0		UNK	UNK			asthma	~ ()~~~In patient	CO6982	1						2	Injection site hypersensitivity; Injection site inflammation; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~6F71239~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0092163	01/15/1998	NE	26.0	25		F	11/28/1997	pt devel a reddened (2x1cm), inflamed, inj site rxn 7 hr p/vax;									U	09/25/1996	09/25/1996	0		UNK	UNK				~ ()~~~In patient	CO6983	1						2	Injection site hypersensitivity; Injection site inflammation	FLU3~CONNAUGHT LABORATORIES~6F71239~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0092164	01/15/1998	IA	37.0	37		F	11/28/1997	pt devel a 2x2cm area on the lt deltoid that was red, hard & inflamed the day p/vax;									U	09/25/1996	09/26/1996	1		OTH	OTH	Premarin;Vitamins			~ ()~~~In patient	CO6981	1						2	Injection site hypersensitivity; Injection site inflammation; Injection site mass	FLU3~CONNAUGHT LABORATORIES~6F71239~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0092221	01/15/1998	OR	40.0	40		F	11/29/1997	1hr post vax pt became flushed from face to mid chest (cheeks being most affected) also had small hives, no itching, some facial tingling;									Y	10/10/1996	10/10/1996	0		OTH	PVT	Amitriptyline, HS		PMH of migraine h/a;tx w/amitriptyline hs for one year	~ ()~~~In patient	CO6999	1						2	Paraesthesia; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71237~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0092222	01/15/1998	OR	26.0	26		M	01/12/1998	pt recv vax 31OCT96 1PM &  1NOV96 4PM pt felt rapid heart beat, felt had a fever, felt faint, felt bad for 45min;the episode resolved over the next 15min;p/primary rxn period pt felt nl;									Y	10/31/1996	11/01/1996	1		UNK	UNK			pt states allergic to cats, allergic to eggs as a child but now no problem;	~ ()~~~In patient	CO6998	1						2	Malaise; Pyrexia; Syncope; Tachycardia	FLU3~CONNAUGHT LABORATORIES~6F71237~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0092308	01/15/1998	MD	67.0	67		F	11/29/1997	pt 11OCT96 &  18OCT96 pt had devel facial edema & hives;				Y					U	10/11/1996	10/12/1996	1		UNK	UNK				~ ()~~~In patient	CO6972	1						2	Face oedema; Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71266~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0092337	01/15/1998	NY	49.0	49		M	11/28/1997	pt recv vax & felt cold & had chills on 23OCT96 3hr post vax;went to MD next day;MD witnessed try rigor, temp reported @ 98.8;pt to ER temp was reported as 104;pt adm & worked up for sepsis;all cult negative;WBC nl, mild hypotension;				Y	Y				U	10/23/1996	10/23/1996	0		UNK	UNK				~ ()~~~In patient	CO6930	1						2	Chills; Hypotension; Pyrexia; Sepsis	FLU3~CONNAUGHT LABORATORIES~6F71297~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0092427	01/15/1998	CA	54.0	54		F	12/03/1997	pt recv vax & devel 10 to 15min of chest constriction, mild in nature, site soreness rt arm & a localized rxn of induration, swelling & redness;9DEC96 extreme itchiness;soreness, itchiness, swelling, redness, mass lasted 1wk;									Y	10/25/1996	10/25/1996	0		UNK	UNK				~ ()~~~In patient	CO6937	1						2	Chest pain; Injection site mass; Injection site oedema; Injection site pain; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71214~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0092446	01/15/1998	NE	33.0	33		F	01/12/1998	pt mom report that w/in 15min of vax pt exp migraine, spots before eyes, numbness in fingers, side of face & nose;pt being seen by neuro;pt incoherent, could not walk, severe h/a that were set off by light;ringing ears;balance or equilibriu				Y					U	10/30/1996	10/30/1996	0		UNK	UNK				~ ()~~~In patient	CO6997	1						2	Confusional state; Coordination abnormal; Gait disturbance; Hypokinesia; Migraine; Paraesthesia; Tinnitus; Visual disturbance	FLU3~CONNAUGHT LABORATORIES~6F71219~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0092669	01/15/1998	MD	66.0			F	11/28/1997	pt devel brachial plexis the day p/vax;pt was reported as not recovered as of 14NOV96;				Y					Y	10/11/1996	10/12/1996	1		PVT	UNK				~ ()~~~In patient	CO6979	1						2	Neuropathy	FLU3~CONNAUGHT LABORATORIES~6F71255~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0093816	01/15/1998	VA	18.0	18		F	11/29/1997	pt recv vax 20OCT96 & immed p/inj pt c/o persistent deep muscular pain in deltoid that persisted for 2wk;no neuromuscular abnormalities were reported p/exam however the area was described as tender;				Y					Y	10/20/1996	10/20/1996	0		OTH	PVT				~ ()~~~In patient	CO7068	1						2	Injection site pain; Myalgia	FLU3~CONNAUGHT LABORATORIES~6F71195~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0094883	01/15/1998	IL	62.0	62		M	12/03/1997	pt devel large ecchymotic area @ the inj site 5 days post vax;13NOV96 pt not yet recovered from this episode;echymotic area covered upper arm on lt;									Y	10/14/1996	10/19/1996	5		UNK	UNK	Coumadin;Lisinopril, DIlantin, Procardia & minitran patches	HTN, CAD, sz;	CAD tx w/coumadin, HTN, sz disorder;	~ ()~~~In patient	CO6896	1						2	Ecchymosis	FLU3~CONNAUGHT LABORATORIES~6F71194~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0095156	01/15/1998	NJ	26.0	26		F	11/29/1997	pt recv vax & less than 6hr post vax pt exp a temp of 103, chills, & body aches;the following day pt was reported as afeb;pt may be a first time vax recipient;;									Y	02/05/1997	02/05/1997	0		UNK	UNK			diabetic treated w/Humulin insulin;	~ ()~~~In patient	CO7085	1						2	Chills; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71313~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0097702	01/15/1998	MD	67.0	67		F	11/28/1997	pt recv vax 11OCT96 & the next day exp allergic rxn w/swelling of the hands, itching of skin & hives;pt also had completed 1wk course of flurbiprofen;pt also had joint inflammation of many joints;									Y	10/11/1996	10/12/1996	1		OTH	OTH	ASA, Vitamin E, Calcium Carbonate, Gemfibrazil, Ortho-est, Provera	no significant acute illness	diabetes, inflamation of joints	~ ()~~~In patient	CO7300	1						2	Hypersensitivity; Oedema peripheral; Osteoarthritis; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71266~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0098040	01/15/1998	GA	31.0	31		F	11/29/1997	pt recv vax 31OCT96 & 1hr p/vax it was reported that pt devel diff breathing, red eyes, swelling of the face, neck & throat & anaphylaxis;there was no hx of egg allergy or any allergies reported;vocal chords have been affected;				Y					U	10/31/1996	10/31/1996	0		UNK	UNK				~ ()~~~In patient	CO7036	1						2	Anaphylactoid reaction; Conjunctivitis; Dyspnoea; Face oedema; Laryngospasm; Oedema	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0102442	01/15/1998	NC	76.0	76		M	11/28/1997	pt recv vax 2OCT96 & reported that as of 19DEC96 pt could not sleep, had bad dreams, severe h/a & earache;felt like was dying;									Y	10/02/1996	12/19/1996	78		PVT	PVT	Lanoxin, Vasotec, VItamins;Pneumovax by lederle		atrial fibrillation	~ ()~~~In patient	CO7060	1						2	Headache; Insomnia; Malaise; Otitis media	FLU3~CONNAUGHT LABORATORIES~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0106403	01/15/1998	MN	90.0	90		M	10/20/1997	pt followed for metastatic melanoma recv flu vax & apparently had sudden death approx 45min later;no prev rxn to flu vax;	Y	10/13/1997							N	10/13/1997	10/13/1997	0		UNK	UNK	Lanoxin;lasix;K-Dur;Allopurinol;	metastatic melanoma;	hx of CHF;metastatic melanoma;	~ ()~~~In patient		1						1	Unevaluable event	FLU3~CONNAUGHT LABORATORIES~7F81816~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0106410	01/15/1998	OR	67.0	67		F	10/15/1997	pt recv flu vax every yr w/o mishap;this yr pt exp swelling @ site of inj;a few hr p/vax site swollen, sore & hot upon exam;ER mD advised to keep site iced-be careful next yr w/flu vax;										10/15/1997	10/15/1997	0		UNK	UNK			NKDA	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4978202~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0106417	01/15/1998	MN	36.0	36		F	12/19/1997	had 2 diameter, red, raised area x 1wk @ inj site;16hr p/vax redness disappeared hit arm ached all the time & had sharp pains when trying to lift anything;used Ibuprofen q6hr x 2mo;unable to lift thing d/t pain; sl ache;									Y	10/14/1997	10/15/1997	1	NONE	PUB	PVT	NONE	NONE	amoxicillin	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pain	FLU3~PFIZER\WYETH~4978186~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0106647	01/15/1998	AZ	73.0	73		F	11/29/1997	pt recv vax 19NOV96 & about 3hr later devel a fever of 104, chills, rales & cold sores (herpes like rash) around the mouth;pt to ER w/T104.8 & adm for observation over night;7JAN97 BP was reported as 223/87, 201/87, pulse 108, resp 24;				Y	Y				Y	11/19/1996	11/19/1996	0		UNK	UNK				~ ()~~~In patient	CO7007	1						1	Chills; Dermatitis bullous; Hypertension; Lung disorder; Mouth ulceration; Pyrexia; Tachycardia	FLU3~CONNAUGHT LABORATORIES~6F71289~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0106807	01/15/1998	WA	50.0	50		M	01/12/1998	pt recv vax 20NOV97 & 22NOV97 pt exp a fever;the next day pt presented to an emergency room w/gen rash that consisted of approx 400 lesions all over mostly above the waist;A specimen of the pt lesions was analyzed via polymerase chain rxn				Y					Y	11/20/1997	11/23/1997	3	24NOV97 diagnostic lab test polymerase chain rxn-wild type virus;	OTH	OTH	Motrin		mental retardation	No relevant data;~ ()~~~In patient	WAES97111693	1						1	Dermatitis bullous; Malaise; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~1101E~1~SC~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0107351	01/15/1998	MD	60.0	60		M	12/01/1997	pt devel a fever of 102 that lasted 2 days p/vax;									Y	10/24/1995	10/25/1995	1		UNK	UNK				~ ()~~~In patient	CO6909	1						1	Pyrexia	FLU3~CONNAUGHT LABORATORIES~5F61100~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107506	01/15/1998	TN				F	11/28/1997	pt devel scalp itching & lip edema 1hr post vax;pt instructed to take DPH;24hr post vax 16JAN96 pt devel gen hives & mild wheezing;pt went to hosp & was treated w/steroids & decadron;				Y					U	10/15/1996	10/15/1996	0		UNK	UNK				~ ()~~~In patient	CO6867	1						1	Asthma; Face oedema; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107507	01/15/1998	LA				U	11/28/1997	pt devel disseminated intravascular coagulation, fever of 106.7, rabid myalgia two & one half wk post vax;									U					UNK	UNK				~ ()~~~In patient	CO6902	1						1	Blood disorder; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107508	01/15/1998	CA	79.0			F	12/30/1997	pt recv vax 24OCT96 & w/in 24hr of vax pt arm had turned black & blue from shoulder to elbow, the inside of mouth became swollen & cracked & fingers became swollen & red @ tips;									U	10/24/1996	10/25/1996	1		UNK	UNK			Renal dialysis pt shunt placed APR96 & pt rx w/dilaudid @ that time;pt reported to have same sx @ that time	~ ()~~~In patient	CO6916	1						1	Ecchymosis; Oedema; Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107509	01/15/1998	OH				U	11/28/1997	pt one of three, devel shingles p/vax;									U					UNK	UNK				~ ()~~~In patient	CO6946	1						1	Herpes zoster; Infection	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107510	01/15/1998	OH				U	11/28/1997	pt two of three devel shingles p/vax;									U					UNK	UNK				~ ()~~~In patient	CO6947	1						1	Herpes zoster; Infection	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107511	01/15/1998	OH				U	11/28/1997	pt three of three devel shingles p/vax;									U					UNK	UNK				~ ()~~~In patient	CO6948	1						1	Herpes zoster; Infection	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107512	01/15/1998	CA	22.0			M	11/28/1997	pt recv vax 6NOV96 & 2hr p/vax pt exp lt sided facial paralysis described as Bell's Palsy;									U	11/06/1996	11/06/1996	0		UNK	UNK				~ ()~~~In patient	CO6964	1						1	Facial palsy	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107513	01/15/1998	WI				F	11/28/1997	pt recv vax 28OCT96 & 9 or 10 days post vax pt devel fever up to 103, chills & body aches;went to see MD & was dx w/flu;pt sx persisted & on a return visit to MD sx were attributed to the flu;				Y					U	10/28/1996	11/07/1996	10		UNK	UNK				~ ()~~~In patient	CO7009	1						1	Chills; Infection; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107514	01/15/1998	NY				F	12/04/1997	pt recv vax & devel fever, flu sx, & being sick for one wk p/vax;									U					UNK	UNK				~ ()~~~In patient	CO7030	1						1	Influenza; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107518	01/15/1998	CA	39.0			F	12/30/1997	pt recv vax NOV96 & sometime p/vax pt exp tremors of the head, neck & hands;neurologist was consulted & on 16JAN97 neurological sx comprise a rather prominent tremor affecting head, neck & hands;brisk deep tendon reflexes;				Y					U					UNK	UNK				~ ()~~~In patient	CO7130	1						1	Hyperreflexia; Tremor	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107520	01/15/1998	FL	80.0	80		F	11/28/1997	pt recv vax 12NOV96 & it was reported that 2wk post vax pt exp soreness @ the gluteal site of inj;1mo post vax it was reported that the exp indentation @ the inj site;pt loosing muscle mass & is c/o muscle weakness in thigh;									U	11/12/1996	11/26/1996	14		UNK	UNK				~ ()~~~In patient	CO7172	1						1	Injection site pain; Muscle atrophy; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107521	01/15/1998	NY	34.0			M	11/28/1997	pt recv vax & devel fever, gen malaise, muscle weakness in the legs;all resolved w/o sequelae;									Y	10/09/1996	10/10/1996	1		UNK	UNK				~ ()~~~In patient	CO6857	1						1	Malaise; Myasthenic syndrome; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71236~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107522	01/15/1998	PA	45.0	44		M	11/28/1997	pt devel chills, fever 102, body aches, just a gen rotten feeling;s/s now beginning to subside, but still feels pretty poor;									Y	10/21/1996	10/22/1996	1		OTH	PVT				~ ()~~~In patient	CO6890	1						1	Chills; Malaise; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71236~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107523	01/15/1998	NC	24.0			F	11/29/1997	pt devel fever, myalgia & h/a 7hr post vax w/flu vax;reported as feeling better 3OCt96;									Y	10/30/1996	10/30/1996	0		UNK	UNK				~ ()~~~In patient	CO6924	1						1	Headache; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71195~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107524	01/15/1998	PA	45.0	44		M	11/28/1997	pt presented w/ fever 101.5, h/a, chills, dry cough, gen malaise for past 3 days;also had concentrated dark yellow urine (sent out for UA) had taken OTC cold/flu med;									Y	10/25/1996	10/26/1996	1	UA revealed an inc speciifc gravity other indices were WNL;	UNK	UNK			allergic to bee stings;	~ ()~~~In patient	CO6926	1						1	Chills; Cough; Headache; Malaise; Pyrexia; Urine analysis abnormal	FLU3~CONNAUGHT LABORATORIES~6F71236~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107525	01/15/1998	NJ	35.0			M	11/28/1997	pt recv vax 930AM 9OCT96 & approx 5PM presented to med dept w/fever, pallor, severe malaise, myalgia, joint pains & diff in walking;tx w/APAP & fluids were forced;									U	10/09/1996	10/09/1996	0		OTH	PVT				~ ()~~~In patient	CO6969	1						1	Arthralgia; Gait disturbance; Hypokinesia; Malaise; Myalgia; Pallor; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71236~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107526	01/15/1998	LA	0.6			M	11/28/1997	pt devel leukopenia (WBC 2.8) & fever of 104 10 hr p/vax;CBC @ the time of incident indicated leukopenia, blood cult were negative;CBC in 10 days was nl;									Y	11/05/1996	11/05/1996	0		PVT	PVT				~ ()~~~In patient	CO6994	1						1	Leukopenia	FLU3~CONNAUGHT LABORATORIES~6F71248~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107529	01/15/1998	NY	47.0			F	11/28/1997	pt recv vax & devel hypesthesia, lt cheek to ear, & h/a following vax w/flu;									U	10/29/1996	10/29/1996	0		UNK	UNK				~ ()~~~In patient	CO6927	1						1	Headache; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~6F71284~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107530	01/15/1998	CA				F	11/28/1997	pt devel localized site rxn of redness, swelling & induration the day of vax;									Y	10/25/1996	10/25/1996	0		UNK	UNK				~ ()~~~In patient	CO6936	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~6F71214~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107532	01/15/1998	OH	47.0	47		F	11/28/1997	pt recv vax & devel Bell's palsy w/in 24hr of vax. From follow-up #1 (12-Nov-1996), the patient was reported as not recovered as of yet. From follow-up #2 (11-Dec-1996), no recovery status was reported. From follow-up phone conservation on July 21, 1999, with doctor's office the correct updated mailing address was provided.				Y					U	10/21/1996	10/22/1996	1		PVT	UNK			Hypothroidism, diabetes;		CO6938	1						1	Diabetes mellitus; Facial palsy; Hypothyroidism	FLU3~CONNAUGHT LABORATORIES~6F71293~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107533	01/15/1998	SC	53.0	53		F	11/28/1997	pt recv vax & devel severe h/a, fever & chills & nausea the day following vax;h/a persisted until 24OCT96;									U	10/22/1996	10/23/1996	1		UNK	UNK				~ ()~~~In patient	CO6939	1						1	Chills; Headache; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71289~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107534	01/15/1998	SC	45.0	44		F	11/28/1997	pt devel nausea, vomiting, sore throat, dry cough & a dime size site erythema, during the day post vax;									Y	10/30/1996	10/30/1996	0		UNK	UNK				~ ()~~~In patient	CO6940	1						1	Cough; Pharyngitis; Rash; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71289~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107535	01/15/1998	SC	31.0	31		M	12/30/1997	pt recv vax & devel fever & chills for 8hr during the day p/vax;									Y	10/31/1996	10/31/1996	0		UNK	UNK				~ ()~~~In patient	CO6941	1						1	Chills; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71289~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107536	01/15/1998	SC	40.0			F	11/29/1997	pt recv vax & devel allergic rxn w/localized itching & a hot spot the size of a saucer, became hypotensive 110/70 according to pt a hypertensive on med;the following morning pt devel malaise & felt poorly;									Y	10/16/1996	10/17/1996	1		UNK	UNK				~ ()~~~In patient	CO6943	1						1	Hypersensitivity; Hypotension; Malaise; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71289~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107537	01/15/1998	SC	46.0	46		F	12/30/1997	pt recv vax 22OCT96 & pt felt dizzy for 30min immed p/vax;pt exp malaise for the next 3 days;on the 4th day 26OCT96 pt exp fever, chills, h/a & nausea;27OCT96 pt felt better;									Y	10/22/1996	10/22/1996	0		UNK	UNK				~ ()~~~In patient	CO6944	1						1	Chills; Dizziness; Headache; Malaise; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71289~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107538	01/15/1998	CA				U	11/28/1997	pt recv vax & devel an arthus type rxn;LMD is concerned that children in the area may have a viral infect @ the time of vax causing this to happen;									U					UNK	UNK				~ ()~~~In patient	CO6945	1						1	Infection; Serum sickness	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107539	01/15/1998	PA				F	11/28/1997	1 of 3 pt devel welts @ the site of inj w/in 24hr p/vax;									U					UNK	UNK				~ ()~~~In patient	CO6950	1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107540	01/15/1998	PA				F	11/28/1997	2 of 3 pt devel welts @ the inj site;									U					UNK	UNK				~ ()~~~In patient	CO6951	1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107541	01/15/1998	PA				F	11/28/1997	3rd pt of 3 devel welts & itching @ the site of inj p/vax;									U					UNK	UNK				~ ()~~~In patient	CO6952	1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107542	01/15/1998	FL	69.0	69		M	11/28/1997	pt recv vax 18OCT96 & started having skin sensitivity, severe h/a, fever, skin disorders & mediastinal pain;1NOV96 T102 w/mediastinal pain;probably contracted some form of viral encephalomyelitis;fever, chills, vigorous shaking;									Y	10/18/1996	10/28/1996	10		OTH	UNK				~ ()~~~In patient	CO6953	1						1	Chest pain; Chills; Encephalopathy; Headache; Infection; Pyrexia; Skin disorder; Tremor	FLU3~CONNAUGHT LABORATORIES~6F71293~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107543	01/15/1998	OH	69.0	69		F	11/29/1997	pt devel angioedema w/in 8hr p/vax;pt reportedly PCN allergic;									Y	11/11/1996	11/11/1996	0		UNK	UNK				~ ()~~~In patient	CO6970	1						1	Angioneurotic oedema	FLU3~CONNAUGHT LABORATORIES~6F71306~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107544	01/15/1998	NY	53.0	53		M	11/29/1997	pt recv vax 9OCT96 & w/in 24hr devel a feeling of illness, low grade fever, leg & arm muscle aches & inj site redness;later pt devel a local rash & arm swelling;persistence of myalgia, fatigue & low grade fever through 13NOV96;									Y	10/09/1996	10/10/1996	1		UNK	UNK				~ ()~~~In patient	CO6971	1						1	Asthenia; Injection site hypersensitivity; Malaise; Myalgia; Oedema peripheral; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71239~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107546	01/15/1998	MD	52.0	52		F	11/28/1997	pt recv vax 17OCT96 & the following day pt devel mild osteoarthritis;pt reportedly has a sacroiliac hx & had surgery a few wk prior to vax;pt exp rt SI joint (?pain severe rxn for 24hr);severe sx, unable to bear weight rt hip;tx w/daypro				Y					Y	10/17/1996	10/18/1996	1		UNK	UNK	Calan;Imitrex;		early cancer of lt breast, resolved w/srugery 1992;hx of hormonal migraines, mild hypertension	~ ()~~~In patient	CO6975	1						1	Arthralgia; Arthritis; Gait disturbance; Hypokinesia	FLU3~CONNAUGHT LABORATORIES~6F71293~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107548	01/15/1998	NJ	49.0	49		F	11/29/1997	pt devel muscles aches, malaise & a fever of 101, duration almost a wk;nurse feels as though vaccine related;									U	11/05/1995	11/05/1995	0		UNK	UNK				~ ()~~~In patient	CO6980	1						1	Malaise; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71355~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107560	01/15/1998	MI	17.0	17		F	11/28/1997	pt devel pain @ inj site @ time of vax;appeared to have much discomfort & described it as knives in arm;pt advised to use motrin for pain & to ice inj site;									Y	11/14/1996	11/14/1996	0		PVT	PVT				~ ()~~~In patient	CO6992	1						1	Injection site pain	FLU3~CONNAUGHT LABORATORIES~6F71322~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107561	01/15/1998	OR	77.0	77		F	12/03/1997	pt devel arthralgia & inflammation in rt arm the day p/vax;									U	10/28/1996	10/29/1996	1		UNK	UNK				~ ()~~~In patient	CO6993	1						1	Arthralgia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71237~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107565	01/15/1998	NJ				F	11/28/1997	pt recv vax & 12hr post vax pt devel urticaria;									Y	11/20/1996	11/21/1996	1		UNK	UNK				~ ()~~~In patient	CO7008	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71306~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107566	01/15/1998	IL	47.0	46		F	11/28/1997	pt recv vax 24OCT96 & the following day pt devel shoulder pain & an axillary lymphadenopathy (4cm) on the rt upper extremity;pt was seen in office on 28OCT96 & rxn was reported to have persisted @ time of report 29NOV96;				Y					Y	10/24/1996	10/25/1996	1		UNK	UNK				~ ()~~~In patient	CO7018	1						1	Lymphadenopathy; Pain	FLU3~CONNAUGHT LABORATORIES~6F71224~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107567	01/15/1998	OH	45.0	45		F	11/28/1997	pt recv vax 9NOV96 & 14 days later reported nausea, vomiting & diarrhea which left pt incapacitated;									Y	11/09/1996	11/23/1996	14		UNK	UNK				~ ()~~~In patient	CO7024	1						1	Diarrhoea; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71227~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107568	01/15/1998	FL	74.0	74		M	11/29/1997	2 days post vax pt reported rt arm soreness that became more painful & sore;weakness started in rt arm & progressed to all extremities;pt stated can't do anything now w/both sides affected, arms & legs;swollen arm, hand;fibromyalgia;				Y					U	10/09/1996	10/11/1996	2		OTH	PVT	Ibuprofen		sciatica	~ ()~~~In patient	CO7027	1						1	Hypokinesia; Myalgia; Myasthenic syndrome; Oedema peripheral; Pain	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107569	01/15/1998	PA	65.0			F	12/30/1997	pt recv vax & 7 days post vax pt devel persistent itching of the lt arm;dermatologists plans to do patch testing for thimersol allergy;				Y					U					UNK	UNK				~ ()~~~In patient	CO7029	1						1	Pruritus	FLU3~CONNAUGHT LABORATORIES~6F71276~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107570	01/15/1998	SC	48.0	48		F	11/29/1997	pt recv vax 30OCT96 & pt exp numbness in the fingers & arthralgia in the lt shoulder;numbness in the fingers resolved as of 2NOV96 -arthralgia persists 12DEC96;painful abduction;while sleeping pain awakens the pt;									N	10/30/1996	10/31/1996	1		UNK	UNK				~ ()~~~In patient	CO7034	1						1	Arthralgia; Hypokinesia; Insomnia; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~6F71289~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107571	01/15/1998	MO	27.0	26		F	11/29/1997	pt recv vax 19NOV96 & 21NOV96 it was reported that pt had devel Bells Palsy;									U	11/19/1996	11/21/1996	2		UNK	UNK				~ ()~~~In patient	CO7035	1						1	Facial palsy	FLU3~CONNAUGHT LABORATORIES~6F71227~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107572	01/15/1998	IL	61.0	61		F	11/29/1997	pt recv vax 6DEC96 & 1 or 2 days later 8DEC96 it was reported that pt devel a fever, rash on back & gen malaise;etiology has yet to be determined because it was reported that this was a first time vaccine recipient;									U	12/06/1996	12/08/1996	2		UNK	UNK				~ ()~~~In patient	CO7038	1						1	Malaise; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~6F71218~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107573	01/15/1998	VA	56.0	56		F	11/28/1997	pt recv vax 15OCT96 & p/vax devel soreness for 3-4 days, then on 25OCT pt had pain in that area;arm hasn't stopped aching since then;doesn't feel that it is the joint but has limited ROM, pt has not yet seen MD;									Y	10/15/1996				UNK	UNK	Estrace			~ ()~~~In patient	CO7059	1						1	Hypokinesia; Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~6F71212~5~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107574	01/15/1998	CA	49.0	49		F	11/29/1997	pt recv vax 19DEC96 &  pt c/o hives on the lt arm (inj site was rt arm) & bilat lower extremities;pt states that the hives began p/vax;				Y					Y	12/19/1996	12/20/1996	1		UNK	OTH	Tagamet, Premarin, Motrin, DPH		allergies, PCN, sulfa, keflex, erythromycin	~ ()~~~In patient	CO7061	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71212~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107575	01/15/1998	NJ	69.0	69		M	11/29/1997	pt recv vax 2JAN97 & was recriminated because prev recv fluogen that was recalled by FDA;3JAN97 pt reportedly did not feel well;4JAN97 c/o chills, nausea, vomiting, diarrhea, h/a;									Y	01/02/1997	01/03/1997	1		PUB	UNK				~ ()~~~In patient	CO7062	1						1	Chills; Diarrhoea; Headache; Malaise; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71316~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107576	01/15/1998	IL	59.0	59		F	11/28/1997	pt recv vax 30OCT96 & 23NOV96 pt devel pain that originated @ the inj site & radiates into the back of neck;also reports pain into he arms & legs;MD described sx as migratory synovitis, myalgias & arthralgia;mild inc ESR;									Y	10/30/1996	11/23/1996	24		OTH	UNK	Fosamax			~ ()~~~In patient	CO7067	1						1	Arthralgia; Injection site pain; Myalgia; Neck pain; Pain; Red blood cell sedimentation rate increased	FLU3~CONNAUGHT LABORATORIES~6F71273~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107577	01/15/1998	CT	45.0	44		F	11/28/1997	pt recv vax 23OCT96 & approx15min p/vax began to devel sx & was seen in ER;4hr p/vax face, tongue, lips & throat were swollen;30JAN97 has outbreaks of hives w/swelling of throat unless on med;recurrent allerg sx				Y					N	10/23/1996	10/23/1996	0		UNK	UNK				~ ()~~~In patient	CO7078	1						1	Face oedema; Hypersensitivity; Laryngospasm; Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71246~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107578	01/15/1998	CO	3.0	3		M	11/28/1997	pt recv vax 1NOV96 & 13NOV96 it was reported that pt could not bear weight on lt leg;x-ray results did not determine a dx;16DEC96 pt reportedly had a sed rate of 48;dx JRA;				Y					Y	11/10/1996	11/13/1996	3		PVT	PVT				~ ()~~~In patient	CO7079	1						1	Gait disturbance; Hypokinesia; Pain; Red blood cell sedimentation rate increased; Rheumatoid arthritis	FLU3~CONNAUGHT LABORATORIES~6F71238~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107579	01/15/1998	MA				F	11/29/1997	pt recv vax 15JAN97 & it was reported that w/in 6 to 9 hr p/vax pt exp local erythema (approx 6 inches in size) & muscle pain @ the site;it was a week a/it subsided, bruising was reportedly present p/vax given;									Y	01/15/1997	01/15/1997	0		UNK	UNK				~ ()~~~In patient	CO7099	1						1	Ecchymosis; Injection site hypersensitivity; Injection site pain; Myalgia	FLU3~CONNAUGHT LABORATORIES~6F71226~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107580	01/15/1998	MA				F	11/28/1997	pt recv vax 15JAN97 & w/in 6 to 9 hr it was reported that pt exp flu sx & the inj site was red, warm & indurated;									Y	01/15/1997	01/15/1997	0		UNK	UNK				~ ()~~~In patient	CO7100	1						1	Influenza; Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71226~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107581	01/15/1998	CA	38.0			F	11/29/1997	3DEC96 seen for bronchitis;18DEC96 c/o dizziness;it was felt that probably had viral labyrinthitis;26DEC96 collapsed on the floor of LMD lobby;also had diarrhea;poss virus;c/o vertigo;MD suspects viral vestibulopathy;SOB, gagging;									U	11/15/1996	11/15/1996	0	MRI of head-negative;	UNK	UNK	DPH;Unisom;			~ ()~~~In patient	CO7113	1						1	Bronchitis; Diarrhoea; Dizziness; Dyspnoea; Hypotonia; Infection; Vestibular disorder; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71227~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107582	01/15/1998	NY	34.0	34		M	01/12/1998	pt exp chest pain tx w/pred;26NOV96 c/o chest discomfort, feeling tired, sore throat, aches in the elbows & lt wrists;pt may be exp esophageal reflux tx w/zantac;c/o pain in elbows, aches in knees;suspected rheumatoid arthritis;				Y					U	10/25/1996			low serum glucose, low serum uric acid & a low urine glucose;CBC, PPT & ESR WNL;lyme screen negative;enlarged thyroid discovered serindipitously;	UNK	UNK	Sporonox;Pred, Zantac;			~ ()~~~In patient	CO7131	1						1	Arthralgia; Asthenia; Chest pain; Gastrointestinal disorder; Laboratory test abnormal; Pain; Pharyngitis; Rheumatoid arthritis	FLU3~CONNAUGHT LABORATORIES~6F71246~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107585	01/15/1998	CA	59.0	59		F	12/03/1997	pt recv vax 31OCT96 & the day of vax pt exp redness & warmth @ the site of vax;4OCT96 pt exp fever, h/a, disorientation & dizziness which persisted for 3 days;exp lt sided back pain & arthralgia;pt stated had diff walking d/t arthralgia;									U	10/31/1996	11/01/1996	1		PVT	PVT				~ ()~~~In patient	CO7354	1						1	Arthralgia; Confusional state; Dizziness; Gait disturbance; Headache; Hypokinesia; Injection site hypersensitivity; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71247~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~431803~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0107586	01/15/1998	CO	27.0	27		F	12/03/1997	hives on pt arms & throat 90min post vax;NO SOB, no diff breathing reported;no hx of allergies to any of the vaccine components;tx w/DPH;									Y	10/01/1996	10/01/1996	0		PUB	PUB				~ ()~~~In patient	CO6825	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71246~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107587	01/15/1998	CA	62.0	62		F	12/03/1997	muscle aches, joint aches, shoulder & upper back area 3 days post vax;									Y	09/25/1996	09/28/1996	3		UNK	UNK				~ ()~~~In patient	CO6827	1						1	Arthralgia; Myalgia	FLU3~CONNAUGHT LABORATORIES~6F71295~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107588	01/15/1998	MI	45.0	45		F	12/30/1997	pt exp bilat conjunctivitis & scleritis p/vax;An ophthalmologist believes this to be r/t immune phenomena;eye cult yielded no growth;									Y	09/26/1996	09/27/1996	1		PVT	PVT	Synthroid		hx of hyperthyroidism, following ablation tx w/secondary hypothyroidism;no sx of any acute or chronic condiitons otherwise;	~ ()~~~In patient	CO6831	1						1	Conjunctivitis; Immune system disorder; Scleritis	FLU3~CONNAUGHT LABORATORIES~6F71285~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107589	01/15/1998	TX	48.0	48		F	11/28/1997	chest pains, inj site red, warm, indurated-large red area @ inj site site 3 diameter, warm & indurated;pt adm to ER 6OT96 having chest pain;ER MD said rxn was totally unrelated to vax;pt had brownish mark @ inj site;allerg rxn				Y					Y	10/02/1996	10/03/1996	1		OTH	PVT				~ ()~~~In patient	CO6833	1						1	Chest pain; Hypersensitivity; Injection site hypersensitivity; Injection site mass; Skin discolouration; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71224~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107590	01/15/1998	CA	71.0	71		F	11/28/1997	pt exp hypoglycemia;LMD stated feels that not related but had to report since may have been possible;pt didn't eat prior to shot either;not sure if w/in min or hr the dose were given;									Y	10/01/1996	10/01/1996	0		UNK	UNK				~ ()~~~In patient	CO6834	1						1	Hypoglycaemia	FLU3~CONNAUGHT LABORATORIES~6F71292~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107591	01/15/1998	PA	70.0	70		F	11/28/1997	rash, bumps all over arms & chest;no blisters broke out, occurred w/in 4hr p/dose given, no allergies known;as far as knows pt isn't taking any med;									Y	10/03/1996	10/03/1996	0		UNK	UNK				~ ()~~~In patient	CO6836	1						1	Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~6F71194~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107592	01/15/1998	WA	71.0	70		F	11/28/1997	redness, swelling, hardness, immed p/vax; it was reported that pt recv vax & exp redness, swelling & hardness @ inj site;MD is treating sx ice & zyrtec & elocon cream;									Y	10/07/1996	10/07/1996	0		PVT	PVT	Decongestants, glucophage;Capoten, Calan & other meds	conjunctivitis		~ ()~~~In patient	CO6837	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~6F71220~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107593	01/15/1998	FL	40.0	40		F	11/28/1997	pt recv vax & exp local rxn, flu like sx;immed area of redness, itching then inc redness & swelling of upper lt arm in red (illegible), lasted 3-4 days;									Y	10/04/1996	10/04/1996	0		UNK	UNK	Ortho tricylien	poss mild URI starting	bronchiectasis	NONE~ ()~~~In patient	CO6838	1						1	Influenza; Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71247~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107594	01/15/1998	PA	19.0			F	12/30/1997	local rxn, large red, itchy;pt recv vax 1OCT96 & 2 days later pt exp a large local rxn described as large (apple sized) red & itchy;									U	10/01/1996	10/03/1996	2		UNK	UNK				~ ()~~~In patient	CO6839	1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71235~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107596	01/15/1998	WI	72.0	72		F	12/03/1997	pt recv vax & had local rxn described as approx the size of a 50 cent piece, red, indurated, warm & hard;									U	10/08/1996	10/09/1996	1		PVT	PVT	APAP PRN		allergies to sulfa, codeine, PCN	~ ()~~~In patient	CO6852	1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71229~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107597	01/15/1998	WA	58.0	58		M	11/28/1997	pt recv vax & devel a scratchy throat, joint aches, rales mid rt chest, productive cough w/yellow sputum;placed on ATB, cult result pending;CXR revealed RLL pneumonia;				Y					U	10/07/1996	10/07/1996	0		PVT	PVT	Ascriptin;Tenormin		ASCAD, hypertension, polycythemia	~ ()~~~In patient	CO6853	1						1	Arthralgia; Cough; Infection; Lung disorder; Pharyngitis; Pneumonia	FLU3~CONNAUGHT LABORATORIES~6F71320~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107599	01/15/1998	CA	7.0	7		F	11/29/1997	pt recv vax 24hr post vax & pt devel hives over entire body w/predominance on legs & abd;no other sx reported;no diff breathing;no SOB, no other swelling;tx w/DPH & did fine for itch & urticaria;				Y					U	10/02/1996	10/03/1996	1		UNK	UNK			Reactive ariways-in control	~ ()~~~In patient	CO6855	1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71246~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107600	01/15/1998	NY	35.0	35		F	11/29/1997	pt recv vax 7OCT96 & the next day 8OCT pt exp fever (unspecified) & a 4x4 area of redness, erythema & induration;									Y	10/07/1996	10/08/1996	1		PVT	PVT	NONE	NONE		NONE~ ()~~~In patient	CO6856	1						1	Injection site hypersensitivity; Injection site mass; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71227~5~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107602	01/15/1998	GA				F	11/28/1997	pt recv vax & 30min post vax pt became dizzy, pale, shaking, clammy & almost passed out;pt was fine when the dose was given, not afraid of inj;									U	10/09/1996	10/09/1996	0		UNK	UNK				~ ()~~~In patient	CO6869	1						1	Dizziness; Hyperhidrosis; Pallor; Syncope; Tremor	FLU3~CONNAUGHT LABORATORIES~6F71278~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107603	01/15/1998	TX	73.0	73		M	11/28/1997	pt recv vax 15OCT96 & 1hr later devel fever 102, rigors @ noc became dysarthric, could not remember names, can't put sentences together & speech still impaired today 17OCT96;									Y	10/15/1996	10/15/1996	0		PVT	PVT	Zestril;Mevacor		HTN, high cholesterol, allergies reported in past for pollen	~ ()~~~In patient	CO6870	1						1	Amnesia; Chills; Dysarthria; Pyrexia; Speech disorder	FLU3~CONNAUGHT LABORATORIES~6F71194~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107604	01/15/1998	IN	41.0	41		F	11/28/1997	pt devel pain in lt arm that radiated to neck, lasted 2 days;pt was not evaluated by MD;									Y	10/08/1996	10/09/1996	1		PUB	PUB				~ ()~~~In patient	CO6871	1						1	Neck pain; Pain	FLU3~CONNAUGHT LABORATORIES~6F71223~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107606	01/15/1998	IN	50.0	50		F	11/28/1997	pt recv vax & devel large localized rxn w/itchiness, was referred to family MD;									Y	10/09/1996	10/09/1996	0		PUB	PUB				~ ()~~~In patient	CO6873	1						1	Injection site reaction; Pruritus	FLU3~CONNAUGHT LABORATORIES~6F71223~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107608	01/15/1998	PA	36.0	36		F	11/28/1997	pt devel sore arm for over a week immed p/being vaccinated;									Y	10/11/1996	10/12/1996	1		UNK	UNK				~ ()~~~In patient	CO6881	1						1	Myalgia	FLU3~CONNAUGHT LABORATORIES~6F71274~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107609	01/15/1998	CT	46.0	46		M	11/28/1997	pt recv vax 15CT96 pt devel GI sx, nausea & diarrhea later that evening;the next had h/a & itching around the collar & neck;2 days later had hive devel on forearm in morning (less than 48hr p/dose given);									Y	10/15/1996	10/15/1996	0		OTH	UNK				~ ()~~~In patient	CO6882	1						1	Diarrhoea; Gastrointestinal disorder; Headache; Nausea; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71308~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107610	01/15/1998	CT	43.0	42		F	11/29/1997	pt recv vax 17OCT96 & the next day 18OCT pt devel puffiness around the eyes & face accompanied by a small, itchy facial rash;									N	10/17/1996	10/18/1996	1		UNK	UNK				~ ()~~~In patient	CO6883	1						1	Face oedema; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~6F71216~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107611	01/15/1998	VA	56.0	56		F	12/03/1997	pt recv vax & w/in 24hr of vax the arm @ site was red, swollen & had pain above the site & in arm pit;w/in 24hr was red & itchy;no allergy to thimersol;									Y	10/16/1996	10/17/1996	1		OTH	PVT				~ ()~~~In patient	CO6884	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Lymphadenopathy; Pruritus	FLU3~CONNAUGHT LABORATORIES~6F71224~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107612	01/15/1998	VA	54.0	54		M	12/03/1997	1wk p/vax pt devel fever of 102.9 for 2 days w/sl h/a & sore throat;									Y	10/07/1996	10/14/1996	7		OTH	PVT	Aleve			~ ()~~~In patient	CO6885	1						1	Headache; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~6F71224~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107613	01/15/1998	PA	44.0	43		M	11/29/1997	several hr post vax pt devel eye bloodshot, face reddened w/swollen lips;during noc lymph nodes painful;started hard cough & sinuses got congested;									Y	10/11/1996	10/11/1996	0		OTH	OTH	Ziac;Dilacor		HTN	~ ()~~~In patient	CO6886	1						1	Conjunctivitis; Cough; Face oedema; Lymphadenopathy; Sinusitis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71277~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107614	01/15/1998	GA	40.0	40		F	11/28/1997	w/in 4hr post vax pt exp shock waves every 5 minutes;now they occur every 5-10sec;pt hasn't slept for days;if there is no stimulation then pt is fine;can't even watch a TV now;described as adrenaline like kick, like when frightened but not				Y					U	10/08/1996	10/08/1996	0		PVT	PVT				~ ()~~~In patient	CO6887	1						1	Insomnia; Tremor	FLU3~CONNAUGHT LABORATORIES~6F71293~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107615	01/15/1998	CT	51.0	51		F	11/28/1997	pt devel pain in vax arm, radiating up arm to neck a few hr post vax;some ear discomfort reported 22OCT96;									Y	10/17/1996	10/17/1996	0		UNK	UNK				~ ()~~~In patient	CO6889	1						1	Ear disorder; Pain	FLU3~CONNAUGHT LABORATORIES~6F71216~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107616	01/15/1998	OH	39.0	39		F	11/28/1997	pt devel redness, induration, warmth & hardness @ site of vax, cleared in 2wk;LMD did not see the rxn;pt on redux bid;									Y	10/05/1996	10/06/1996	1		UNK	UNK	Redux			~ ()~~~In patient	CO6891	1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71289~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107617	01/15/1998	OH				U	11/28/1997	pt devel redness, induration, warmth & hardness @ the site of vax;LMD did not see rxn;									Y	10/05/1996	10/06/1996	1		UNK	UNK				~ ()~~~In patient	CO6892	1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~6F71289~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107618	01/15/1998	MO	54.0	54		F	12/30/1997	sore throat, aches, chills, h/a, tight chest devel by pt 1 day post vax;									U	10/18/1996	10/19/1996	1		UNK	UNK				~ ()~~~In patient	CO6893	1						1	Chest pain; Chills; Headache; Myalgia; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~6F71292~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107619	01/15/1998	MA	33.0	33		M	11/28/1997	noc sweats, hallucinations, head pain, heavy legs, behavior changes;pt reported hypochondriac;pt informed by ER MD that had a vaccine allerg rxn & it would resolve on its own;pt disch from ER w/no tx or tests;				Y					Y	10/16/1996	10/17/1996	1		PVT	PVT				~ ()~~~In patient	CO6894	1						1	Hallucination; Headache; Hyperhidrosis; Hypersensitivity; Myasthenic syndrome; Personality disorder	FLU3~CONNAUGHT LABORATORIES~6F71308~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107620	01/15/1998	WA	46.0	45		F	11/28/1997	pt recv vax 14OCT96 & the next day pt exp an erythema rxn @ the inj site;rxn lasted 1wk now 22OCT96 looks bruised;can see where the med had spread in that area but doesn't feel bruised;									Y	10/14/1996	10/15/1996	1		UNK	UNK				~ ()~~~In patient	CO6895	1						1	Ecchymosis; Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~6F71320~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107622	01/15/1998	TX				M	11/28/1997	pt devel progressively worsening hives that began 12hr post vax;irregular size welts started on stomach, spread side to side, spreading to neck;nurse does not feel that rxn is vaccine related because progressively getting worse;									U	10/04/1996	10/04/1996	0		UNK	UNK				~ ()~~~In patient	CO6898	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71273~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107623	01/15/1998	NM	33.0	33		F	11/28/1997	pt devel enlarged lymph nodes the day following vax;node smaller but still palpable;									Y	10/18/1996	10/19/1996	1		PVT	UNK	Interferon TIW			~ ()~~~In patient	CO6899	1						1	Lymphadenopathy	FLU3~CONNAUGHT LABORATORIES~6F71226~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107624	01/15/1998	WI	39.0	39		F	11/28/1997	pt recv vax 16OCT96 & that same day pt exp pain radiating down arm causing numbness in hand & pain in neck;									U	10/16/1996	10/16/1996	0		UNK	UNK				~ ()~~~In patient	CO6900	1						1	Neck pain; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~6F71223~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107625	01/15/1998	CA	42.0	42		F	11/29/1997	pt recv vax & devel lateral arm discomfort & shoulder tenderness, no erythema, no swelling;pain not @ site but in arm & shoulder, same side as inj;									N	10/07/1996	10/14/1996	7		UNK	UNK				~ ()~~~In patient	CO6903	1						1	Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~6F71220~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107626	01/15/1998	MI	55.0	55		F	11/28/1997	pt devel extreme pain & reduced ROM p/vax;pt reported inability to lift arm more than 20 degrees;also happened last year w/inj & LMD advised pt not to get vax again;									Y	09/23/1996	09/23/1996	0		PVT	PVT				~ ()~~~In patient	CO6905	1						1	Hypokinesia; Pain	FLU3~CONNAUGHT LABORATORIES~6F71227~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107627	01/15/1998	CA				U	11/29/1997	pt recv vax 23OCT96 & next day 24OCT96 devel cellulitis around the inj site;									U	10/23/1996	10/24/1996	1		UNK	UNK				~ ()~~~In patient	CO6906	1						1	Cellulitis	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107628	01/15/1998	CA				U	11/29/1997	pt recv vax 23OCT96 & the next day 24OCT96 pt devel cellulitis around inj site;									U	10/23/1996	10/24/1996	1		UNK	UNK				~ ()~~~In patient	CO6907	1						1	Cellulitis	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107629	01/15/1998	CO	48.0	48		F	11/29/1997	pt devel a painful, swollen arm the day p/vax;									Y	10/02/1996	10/03/1996	1		PVT	PVT				~ ()~~~In patient	CO6914	1						1	Oedema peripheral; Pain	FLU3~CONNAUGHT LABORATORIES~6F71308~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107630	01/15/1998	CO	67.0	67		F	11/28/1997	pt devel a painful swollen arm the day p/vax;									U	10/03/1996	10/04/1996	1		UNK	UNK				~ ()~~~In patient	CO6915	1						1	Oedema peripheral; Pain	FLU3~CONNAUGHT LABORATORIES~6F71321~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107631	01/15/1998	PA				U	11/28/1997	breathing difficulty, facial swelling, urticaria;									U					UNK	UNK				~ ()~~~In patient	CO6919	1						1	Dyspnoea; Face oedema; Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71255~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107632	01/15/1998	PA				U	11/28/1997	breathing difficulty, facial swelling, urticaria;									U					UNK	UNK				~ ()~~~In patient	CO6920	1						1	Dyspnoea; Face oedema; Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71255~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107633	01/15/1998	PA				U	11/28/1997	breathing difficulty, facial swelling, hives;									U					UNK	UNK				~ ()~~~In patient	CO6921	1						1	Dyspnoea; Face oedema; Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71255~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107634	01/15/1998	MA	75.0			F	11/28/1997	pt recv vax & 1 or 2 days p/vax pt devel a persistent (through 3OCT96) low grade fever, malaise, anorexia & a weight loss of 7 pounds;									U	10/10/1996			CXR showed no significantly different changes;CBC reported predominently neutrophils;Blood cult & UA were negative;ESR was WNL;	UNK	UNK			COPD	~ ()~~~In patient	CO6922	1						1	Anorexia; Malaise; Pyrexia; Weight decreased	FLU3~CONNAUGHT LABORATORIES~6F71226~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107635	01/15/1998	LA	41.0	41		F	11/29/1997	pt recv vax & devel acute transverse myelitis 10 days p/vax;27OCT96 pt devel sharp pain between scapula 0 zero SOB, recurring pain w/n/v, urinary retention;dx negative;numbness hips & trunk to T4 level;strength dec;limp;some trunk numbness				Y					N	10/16/1996	10/27/1996	11	CT chest & thorax negative;MRI spine/brain/brainstem negative;LP CNS protein 33, glucose 118;other labs still pending;	PVT	PVT				~ ()~~~In patient	CO6923	1						1	CSF test abnormal; Gait disturbance; Myasthenic syndrome; Myelitis; Pain; Paraesthesia; Urinary retention; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71273~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107636	01/15/1998	PA	36.0			M	11/28/1997	pt 4.5 hr post vax devel a tight throat, swollen lips, chest tightness & numbness of the lower face & jaw;tightness lasted 20min, numbness & swelling cont;tx w/DPH;									Y	10/26/1996	10/26/1996	0		UNK	UNK				~ ()~~~In patient	CO6925	1						1	Chest pain; Face oedema; Laryngospasm; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~6F71255~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0105038	01/16/1998	MD	60.0	60		F	12/15/1997	9 days p/vax pt exp facial pressure & loss of taste;also had pulling sensation in back of legs;exp diff focusing eyes, numbness of tongue & mouth, dysphagia;epigastric pain;diff walking, weakness of hand;dx GBS;constipated;				Y	Y	20			Y	10/10/1997	10/19/1997	9		PVT	OTH	Cardizem CD;Furosemide;Estraderm;Ecotrin;Lipitor;Xanax;Nitroglycerin	NONE		~ ()~~~In patient	897351025L	1						2	Abdominal pain; Ageusia; Constipation; Dysphagia; Guillain-Barre syndrome; Myasthenic syndrome; Paraesthesia; Visual disturbance	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0106423	01/16/1998	MA	35.0	35		F	12/29/1997	pt recv vax 17OCT97 & w/in a few days dx w/aseptic meningitis;hosp is presumed although not documented;					Y				U	10/17/1997				PVT	OTH	LEVO-T daily	NONE	hypthyroidism	~ ()~~~In patient	897365004L	1						1	Meningitis	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0106424	01/16/1998	LA	69.0	69		F	01/12/1998	pt recv vax 1997 & inadvertently was vaccinated w/2nd dose of pneumococcal vax in JAN98;JAN97 pt exp high fever, acute pain, n/v;pt has been in & out of hosp;also noted that events all cycle;					Y				N	01/01/1998	01/01/1998	0		PVT	PVT	Synthroid		drug allergy;intestinal surgery;PCN allergy;skin malignant neoplasm;sulfa allergy	~ ()~~~In patient	WAES98010184	1						1	Arthralgia; Hypokinesia; Osteoarthritis; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~~2~~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0106438	01/16/1998	VT	53.0	53		F	01/12/1998	pt reported persistent soreness in lt arm & devel of tendonitis since flu shot;feels nurse gave shot too far back in arm;pt has been seen by MD & can not find cause for tendonitis-? flu shot only started since recv vax;				Y						10/17/1997				OTH	PVT		NONE	diabetes	~ ()~~~In patient		1						1	Pain; Tendon disorder	FLU3~CONNAUGHT LABORATORIES~7F81788~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0106439	01/16/1998	VT	33.0	33		F	01/12/1998	pt reported persistent lump about the size of walnut from flu shot;				Y						10/17/1997			unk	OTH	PVT		NONE	NONE	pt exp abscess p/vax;~ ()~~~In patient		1						1	Injection site mass	FLU3~CONNAUGHT LABORATORIES~7F81894~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0106663	01/20/1998	AK	48.0	48		F	01/09/1998	pt devel immed tightening in chest-diff breathing became flush & had to sit down;				Y					Y	01/06/1998	01/06/1998	0	NONE	PVT	OTH	Zanax;Vitamins;Doxipan;Minoril;Quamipin	NONE	allergies to codeine, deseril, dylantin, talair;depression, post traum degen disc	~ ()~~~In patient		1						1	Chest pain; Dyspnoea; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0106295	01/21/1998	NJ	68.0	68		F	10/03/1997	2 days p/vax pt exp gen aching-type pain in both knees, going down to feet;									U	09/29/1997	10/01/1997	2		PVT	PVT	unk	NONE			897293030L	1						2	Arthralgia; Myalgia; Pain	FLU3~MEDEVA PHARMA, LTD.~E3327GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|HEPA~SMITHKLINE BEECHAM~539B6~UNK~IM~LA~HEP A (HAVRIX)~2|OPV~PFIZER\WYETH~445626~UNK~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~2|TD~CONNAUGHT LABORATORIES~7E91672~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~2	USA		Influenza
0106699	01/21/1998	MD				F	01/15/1998	pt recv vax 24OCT97 & 11NOV97 pt exp numbness of legs, suspecting GBS pt returned to Brazil;MD in Brazil feel that its related to flu vax;pt had trouble swallowing & was on a liquid diet;pt reportedly wheelchair bound & could not walk;									U	10/24/1997	11/11/1997	18		UNK	UNK				~ ()~~~In patient	CO7824	1						1	Anorexia; Dysphagia; Guillain-Barre syndrome; Hypokinesia; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0106723	01/21/1998	PA	78.0	78		M	12/17/1997	itching & burning, felt like poison ivy;denies allergy to chicken or eggs;denies exposure to poison ivy;									Y	10/10/1997	10/13/1997	3		OTH	OTH	NA	Denies		~ ()~~~In patient		1						1	Pain; Pruritus	FLU3~PFIZER\WYETH~4978145~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0106726	01/21/1998	NM	49.0	49		F	12/11/1997	9hr p/vax pt devel twitching & soreness in throat, h/a & gen malaise;w/in 2 days extreme congestion, fever, body aches & disoriented 'mortality dream images' occurred;congestion in lungs cont until 1DEC97;									U	10/22/1997	10/22/1997	0	NONE	OTH	OTH	NONE	stress no other illness	allergies dx & antigens taken in 1996;(stopped MAY96) not include chicken or eggs;	NONE~ ()~~~In patient		1						1	Abnormal dreams; Cough decreased; Headache; Muscle twitching; Myalgia; Pharyngitis; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107096	01/21/1998	NC	14.0	14		U	10/27/1997	pt recv vax & w/in a few hr pt devel an inj site rxn characterized by soreness & a nodule;									U	10/24/1997	10/24/1997	0		PUB	OTH	unk	unk		~ ()~~~In patient	897321009L	1						1	Injection site mass; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~PFIZER\WYETH~~1~SC A~~HIB (HIBTITER)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0106739	01/23/1998	MA	67.0	67		F	01/12/1998	heavy red circle around inj site lt arm swollen by noc;cellulitis devel; rx w/IV ATB;				Y					Y	09/09/1997	09/09/1997	0		PVT	UNK		NONE	allergies	~ ()~~~In patient		1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~7581775~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0906E~2~SC~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0106741	01/23/1998	NJ	65.0	65		F	01/17/1998	20OCT pain in upper arm;21OCT cont pain in arm (p/a sleepless noc), swelling above & below area of shot;22OCt heat, redness, cont swelling spreading over larger area, visit to family MD, antihistamine & steroids prescribed;				Y					Y	10/20/1997	10/21/1997	1		PUB	PUB	NONE	NONE	sulfa, seasonal allergies;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81896~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~444067~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0106752	01/23/1998	AZ	13.0	13		M	01/12/1998	acute urticaria-day 3 post vax;									Y	11/11/1997	11/14/1997	3	NA	OTH	OTH	Flonase, Proventi/MDI	NONE	seasonal allergic rhinitis/RAD (asthma)/obesity	NA~ ()~~~In patient		1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0106934	01/26/1998	NY	63.0	62		F	01/08/1998	pt recv vax & devel a bad cold;w/in 2 days post vax pt had diff breathing was hosp & regular mechanical ventilation;pt was d/c from hosp p/2wk;			Y		Y				Y	10/20/1997				PUB	OTH	unk	unk		~ ()~~~In patient	898013003L	1						1	Dyspnoea; Hypoxia; Pharyngitis; Rhinitis	FLU3~PFIZER\WYETH~4978144~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0106942	01/26/1998	OH	53.0	53		F	01/20/1998	pain, warmth, myalgias  @ site;no hematoma;no cellulitis;sx persisted x 1mo;labs CPK, aldolase normal;sed rate 18 (on NSAIDS) negative paresthesias;				Y					N	12/12/1997	12/13/1997	1		PVT	PVT	Premarin	NONE	h/ lyme disease 1989, +ANA, endometrosis, Fordyce's disease, eczema;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Myalgia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81794~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0106943	01/26/1998	IN	23.0	23		F	01/20/1998	pt recv vax 29OCT97 & dx as post antibody brachial plexus;c/o numbness index finger lt hand;EMG 4DEC97 idiopathic brachial neuritis;				Y					Y	10/29/1997	01/01/1998	64	EMG	PUB	PVT	birth control	NONE	NONE	NONE~ ()~~~In patient		1						1	Neuritis; Paraesthesia	FLU3~PFIZER\WYETH~4978140~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0106949	01/26/1998	GA	62.0	62		F	11/26/1997	pt had light-headedness p/inj;BP was checked & found to be elevated 160/100 (seated);primary provider was called to see if wanted to see pt BP checked 10min;later was 170/100 (seated);MD advised to call amb & send pt to ER for further eval;				Y					Y	11/26/1997	11/26/1997	0		PUB	PUB	NONE	pt denies	elevated triglycerides, positive cardio family hx	~ ()~~~In patient	GA97146	1						1	Dizziness; Hypertension	FLU3~CONNAUGHT LABORATORIES~7F81904~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0106950	01/26/1998	GA	14.0	14		F	11/18/1997	dizzy, clammy, cold, seeing spots, feels as if is hallucinating, crying, claims is hot, vomiting;19DEC doing very well flu like sx lasted 3 days;				Y					U	11/17/1997	11/18/1997	1	NA	PUB	PUB	Serzome	NONE	asthma	NA~ ()~~~In patient	GA97148	1						1	Agitation; Chills; Dizziness; Hallucination; Hyperhidrosis; Vasodilatation; Visual disturbance; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81930~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0106953	01/26/1998	GA	35.0	35		F	12/04/1997	pt recv vax 1DEC97 & states 2DEC97 devel a rash-slept little that noc saw pvt MD 3DEC97 & was given med;T102.9;				Y					Y	12/01/1997	12/02/1997	1		PUB	UNK		NONE	migraines/back pain	NA~ ()~~~In patient	GA97151	1						1	Insomnia; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~7F81916~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SMITHKLINE BEECHAM~23000B6~1~IM~LA~HEP B (ENGERIX-B)~1|PPV~MERCK & CO. INC.~0950D~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~7C91574~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0106954	01/26/1998	GA	68.0	68		F	12/08/1997	vomiting 24hr p/vax;@ 48hr had severe h/a & body pains, not relieved w/APAP, felt weak & faint;@ 72hr pain intense, went to Er had shots for pain 15OCT97;went back to ER same sx MD said rxn to vax 8DEC97;recovered;				Y					Y	10/02/1997	10/03/1997	1	NONE	PUB	PUB	NONE	denied	sulfa	NONE~ ()~~~In patient	GA97152	1						1	Asthenia; Dizziness; Headache; Myalgia; Pain; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81854~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~433402~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0106955	01/26/1998	GA	62.0	62		F	12/08/1997	flu 2wk p/vax treated w/ Keflex & decongestion 22OCT97; 1 wk later went to ER treated w/Biaxin & duratuss;saw MD 2 days later as follow up treated w/theophyllin, cough med, cyndal HD, vit C & herbal vitamin 7NOV97 still sx fatigue 8DEC97;				Y					Y	10/09/1997	10/21/1997	12	NONE	PUB	PUB	NONE	Denied	ASA, sulfa, codeine, REBAC, NONCAN, IV DYE	NONE~ ()~~~In patient	GA97153	1						1	Asthenia; Influenza; Rhinitis	FLU3~CONNAUGHT LABORATORIES~7F81854~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0106957	01/26/1998	MD	61.0	61		F	01/18/1998	pt recv vax 5NOV97 & hurt when needle was given;could not raise arm up or move in any direction;				Y						11/05/1997				PUB	PVT		NONE		~ ()~~~In patient		1						1	Hypokinesia; Injection site pain	FLUX~UNKNOWN MANUFACTURER~41050~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~411050~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0106959	01/26/1998	OK	43.0	43		M	01/06/1998	pt recv vax 20NOV97 & exp rxn to flu vax & or flu;pt states 1PM yesterday it hit him like a log;chills, fever, aching, so went home to bed;awoke w/bed like a lake;today aches all over & fever 107.4;ice packs on head w/cold showers;										11/20/1997	01/05/1998	46		PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	OK982	1						1	Hyperhidrosis; Influenza; Malaise; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81931~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0106960	01/26/1998	OK	64.0	64		F	10/30/1997	whelps on rt side, rt arm & rt axillary area;denied itching;pt put menthol & TMC on whelps;come down w/sore throat, cough, & congestion lasting 7 days;									Y	10/30/1997	10/30/1997	0	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	OK9749	1						1	Cough; Pharyngitis; Rhinitis; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81931~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0106961	01/26/1998	OK	44.0	44		F	10/29/1997	pain, redness, bruising, swelling 80x70 @ inj site, pt stated felt like a bee sting;arm sore 3-4 days;									Y	10/28/1997	10/28/1997	0	NONE	PUB	PUB	NONE	NONE	allergic to bee stings	NONE~ ()~~~In patient	OK9748	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~E3277GA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0106962	01/26/1998	OK	65.0	65		F	12/08/1997	pt recv flu vax & redness, swelling to elbow site warm, fever, malaise;									Y	10/27/1997	10/28/1997	1		PVT	PVT				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Malaise; Pyrexia; Vasodilatation; Injection site hypersensitivity; Injection site oedema; Malaise; Oedema peripheral; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4978140~1~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0106963	01/26/1998	OK	74.0	74		M	12/08/1997	pt recv flu vax & pneumococcal vax combined & given in one inj & exp cellulitis to elbow, fever, site warm, pain;DPH, ATB per MD;									Y	10/27/1997	10/28/1997	1		PVT	PVT				~ ()~~~In patient		1						1	Cellulitis; Injection site pain; Injection site reaction; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4978140~1~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~UNKNOWN MANUFACTURER~0845D~1~IM~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0106964	01/26/1998	OK	77.0	77		F	12/08/1997	pt recv flu vax & pneumococcal vax combined & given in one inj & exp cellulitis to elbow, fever, pain, site warm;									Y	10/27/1997	10/28/1997	1		PVT	PVT				~ ()~~~In patient		1						1	Cellulitis; Injection site reaction; Pain; Vasodilatation; Cellulitis; Pain; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4978140~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0106965	01/26/1998	OK	73.0	73		F	12/08/1997	pt recv flu & pneumococcal vax combined & given one inj & exp redness, swelling to elbow, site warm;given DPH & APAP per MD;									Y	10/27/1997	10/28/1997	1		PVT	PVT				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Vasodilatation; Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4978140~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0106966	01/26/1998	OK	70.0	70		M	12/08/1997	pt recv flu & pneumococcal vax combined & given in one inj & exp redness, sl swelling, site warm;									Y	10/27/1997	10/28/1997	1		PVT	PVT				~ ()~~~In patient		1						1	Oedema; Vasodilatation; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4978140~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0106967	01/26/1998	OK	58.0	58		F	12/08/1997	pt recv flu & pneumococcal vax combined & given one inj & exp redness, swelling to elbow, fever x 2 days, rash on chest/neck;DPH given per MD;									Y	10/27/1997	10/28/1997	1		PVT	PVT				~ ()~~~In patient		1						1	Oedema peripheral; Pyrexia; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4978140~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0106968	01/26/1998	OK	70.0	70		M	12/08/1997	pt recv flu & pneumococcal vax combined & given in one inj & exp soreness @ site;									Y	10/27/1997	10/27/1997	0		PVT	PVT				~ ()~~~In patient		1						1	Injection site pain; Injection site pain	FLU3~PFIZER\WYETH~4978140~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~RA~PNEUMO (PNEUMOVAX)~1|DTP~UNKNOWN MANUFACTURER~~1~IM~~DTP (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0106969	01/26/1998	OK	79.0	79		F	12/08/1997	pt recv flu & pneumococcal vax combined & given in one inj;sl soreness @ site;									Y	10/27/1997	10/27/1997	0		PVT	PVT				~ ()~~~In patient		1						1	Injection site pain	FLU3~PFIZER\WYETH~4978140~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0106970	01/26/1998	OK	67.0	67		F	12/08/1997	pt recv flu & pneumococcal vax combined & given in one inj & exp redness, swelling, site warm;									Y	10/27/1997	10/28/1997	1		PVT	PVT				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4978140~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0106971	01/26/1998	OK	87.0	87		F	12/08/1997	Flu and pneumovax combined and given in one inject. Slight soreness @ site.									Y	10/27/1997	10/27/1997	0		PVT	PVT				~ ()~~~In patient		1						1	Injection site pain	FLU3~PFIZER\WYETH~4978140~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0106972	01/26/1998	OK	66.0	66		F	12/08/1997	pt recv flu vax & pneumococcal vax combined & given in one inj & exp redness, induration, site warm, malaise, pain, h/a;									Y	10/27/1997	10/28/1997	1		PVT	PVT				~ ()~~~In patient		1						1	Headache; Injection site hypersensitivity; Injection site mass; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4978140~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0106973	01/26/1998	OK	76.0	76		U	12/08/1997	pt recv flu vax & pneumococcal vax combined & given in one inj;pt exp sore arm only;									Y	10/27/1997	10/27/1997	0		PVT	PVT				~ ()~~~In patient		1						1	Pain	FLU3~PFIZER\WYETH~4978140~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0106974	01/26/1998	OK	79.0	79		F	12/08/1997	pt recv flu & pneumococcal vax combined & given in one inj & exp redness, swelling to elbow, site hard & warm, malaise, pain;told to put heat by ER nurse;									Y	10/27/1997	10/28/1997	1		PVT	PVT				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Malaise; Oedema peripheral; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4978140~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0106975	01/26/1998	OK	75.0	75		F	12/08/1997	pt exp flu vax & pneumococcal vax combined & given in one inj & pt exp sore arm only;									Y	10/27/1997	10/27/1997	0		PVT	PVT				~ ()~~~In patient		1						1	Pain	FLU3~PFIZER\WYETH~4978140~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0106976	01/26/1998	NV	45.0	45		F	01/06/1998	exp pain in rt shoulder still a mon /p inject - numbness in thumb, fingers rt hand. seen by OH and MD at clinic - put on ATB & anti-inflamtory, no change in sx									U	11/10/1997	12/01/1997	21		OTH	PVT				~ ()~~~In patient	NV98001	1						1	Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~7F81903~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0106977	01/26/1998	NV	42.0	42		F	12/10/1997	1wk p/vax pt woke up w/numbness in lt arm from deltoid radiating down;this has cont for the past 6-7wk not getting better or worse;pt seen by 2 MD w/o any answer;									N	10/02/1997	10/09/1997	7	MRI nl	PUB	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	NV97027	1						1	Paraesthesia	FLU3~CONNAUGHT LABORATORIES~7F81799~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0106983	01/26/1998	CO	55.0	55		F		muscle spasms rt shoulder, arm, hand (extreme);when pt not taking anti-inflammatory pain returns;took Darvocet for 2wk, Vicodin for 3wk, ATB, muscle relaxlants, anti inflammatory for 3.5mo;saw MD;still wrist pain & hand pain;									N	09/18/1997				PVT	PVT			NONE;breast cancer	~ ()~~~In patient		1						1	Hypertonia; Pain	FLU3~PFIZER\WYETH~4978147~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0106993	01/26/1998	OH	8.0	8		M		rash reported per mom x 24-48hr;no DPH;resolved spontaneously;									Y	11/11/1997	11/12/1997	1	NONE	PVT	PVT	Vanceril, Proventil	NONE	allergic-amox-rash, asthma	~ ()~~~In patient		1						1	Rash	FLU3~CONNAUGHT LABORATORIES~7F81884~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0106996	01/26/1998	OK	85.0	85		F	12/08/1997	pt recv flu vax & pneumococcal vax combined & given in one inject;									Y	10/27/1997				PVT	PVT				~ ()~~~In patient		1						1	Unevaluable event; Injection site pain	FLU3~PFIZER\WYETH~4978140~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0106997	01/26/1998	OK	65.0	65		M	12/08/1997	pt recv flu & pneumococcal vax combined & given in one inj									Y	10/27/1997				PVT	PVT				~ ()~~~In patient		1						1	Unevaluable event	FLU3~PFIZER\WYETH~4978140~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0106998	01/26/1998	OK	38.0	38		F	12/08/1997	pt recv flu & pneumococcal vax combined & given in one inject;									Y	10/27/1997				PVT	PVT				~ ()~~~In patient		1						1	Unevaluable event; Injection site pain; Wrong technique in product usage process	FLU3~PFIZER\WYETH~4978140~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~IM~UN~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0106999	01/26/1998	OK	69.0	69		M	12/08/1997	pt recv flu & pneumococcal vax combined & given in one inject;									Y	10/27/1997	10/28/1997	1		PVT	PVT				~ ()~~~In patient		1						1	Unevaluable event	FLU3~PFIZER\WYETH~4978140~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0107000	01/26/1998	OK	74.0	74		M	12/08/1997	pt recv flu & pneumococcal vax combined & given in one inject & exp redness, swelling, site arm, fever;									Y	10/27/1997	10/27/1997	0		PVT	PVT				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4978140~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0109146	01/26/1998	NC				U	10/16/1997	1 of 6 elderly pts who devel inject site rxn of swelling,erythema. Pt has received flu vax each of the past few yr.									U					PUB	OTH	UNKNOWN	UNK		~ ()~~~In patient	897296004L	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0107002	01/27/1998	FL	61.0			F	12/22/1997	pt recv vax & exp weakness & numbness of extremities for GBS;pt adm to hosp & given med;dx rt frontal lobe hemorrhage;					Y						11/18/1997		Baseline MRI negative;18NOV97 MRI revealed a rt frontal lobe hemorrhage;	UNK	UNK	Immune Globulin IV, Sandoglobulin given 7NOV97		hx of diabetes & HTN;	~ ()~~~In patient		1						1	Guillain-Barre syndrome; Haemorrhage intracranial; Myasthenic syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0107003	01/27/1998	PA	51.0	50		M	01/08/1998	pt recv vax 3NOV97 & exp stomach virus 13NOV97;GBS dx 22NOV97;Gamma Globulin tx;physical therapy;				Y	Y	21			Y	11/03/1997	11/13/1997	10		PUB	PVT	NONE	NONE	allergy PCN	~ ()~~~In patient		1						1	Gastrointestinal disorder; Guillain-Barre syndrome; Infection	FLU3~PFIZER\WYETH~4978162~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0107013	01/27/1998	WA	31.0	31		F	12/18/1997	8cm x 8cm red raised area @ inj site lt deltoid;tender & warm-body aches-chills;				Y					Y	08/16/1997	08/17/1997	1		PVT	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Chills; Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia; Vasodilatation	FLU3~PFIZER\WYETH~4978150~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~7D91611~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0107015	01/27/1998	PA	30.0	30		M	01/20/1998	pt became woozy & fell to ground, bumping head a few min p/vax;pt c/o feeling heavy, tingling of hands, no SOB, no rash, no loss of consciousness;amb took pt to hosp;				Y					Y	10/28/1997	10/28/1997	0		OTH	UNK				~ ()~~~In patient		1						1	Dizziness; Injury; Myasthenic syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~7F81840~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107016	01/27/1998	PA	60.0	60		M	01/20/1998	c/o weakness, sweating reported to school nurse w/ BP 98/60, P32?;pt normally hypertensive-MD ?BP med 2 days prior;sent to ER via amb;seen & released by hosp;				Y					Y	10/08/1997	10/08/1997	0		OTH	UNK				~ ()~~~In patient		1						1	Asthenia; Bradycardia; Hyperhidrosis; Hypotension	FLU3~CONNAUGHT LABORATORIES~7F81854~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107017	01/27/1998	PA	59.0	59		F	01/20/1998	vomiting & pain in abd went to hosp;vomited Friday night, Saturday AM stopped 5AM Monday;fever 100;				Y					Y	10/03/1997	10/03/1997	0	IVRX, xrays, r/o appendicitis;	OTH	UNK				~ ()~~~In patient		1						1	Abdominal pain; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81854~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107020	01/27/1998	NY	43.0	43		F	01/21/1998	24hr p/vax pt devel lt runny nose w/o cold sx;severe h/a, considered sinusitis;negative scan & unresponsive to sinus therapy;1wk later double vision;nerve paresis suggesting cavernous sinus synd likely for ischemic cranial neuropathy;				Y					U	11/12/1997	11/13/1997	1	spinal tap, MRI, MRA, blood work up, LP	PVT	UNK				~ ()~~~In patient		1						1	Cerebral ischaemia; Diplopia; Headache; Neuropathy; Paralysis; Rhinitis; Sinusitis	FLU3~MEDEVA PHARMA, LTD.~E20047KC~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0106336	01/28/1998	WY	19.0	18		M	01/06/1998	states felt fine until 8PM then chills, noc sweats, body aching, lt arm pit edema, 2 red streaks from lt deltoid to arm pits, & tightness in chest when deep breathing;6JAN97 seen @ clinic, Augmentin x 10 days;pt states feels better 6JAN98				Y					U	01/05/1998	01/05/1998	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	WY982	1						2	Chest pain; Chills; Hyperhidrosis; Lymphadenopathy; Myalgia; Skin striae; Chest pain; Chills; Hyperhidrosis; Lymphadenopathy; Pruritus; Skin striae	FLU3~PFIZER\WYETH~4978213~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~7E91672~5~IM~RA~TD ADSORBED (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4978213~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~2|TD~CONNAUGHT LABORATORIES~7E91672~1~IM~RA~TD ADSORBED (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0107033	01/28/1998	NC	61.0	61		M	01/16/1998	n/v, h/a (double vision, unable to focus, staggering gait;eye movement rt dec 80degree out to rt;has improved 95%;3rd cranial nerve +;					Y	4		Y	N	11/07/1997	11/09/1997	2	EEG, head scan, brain stem study-MRI/enhanced-echogram	UNK	PUB	GLucophage;Glyburide;Prevacid;Norvasc;HCTZ;Cardura;Lotension;baby ASA	NONE	diabetes/hypertension/NKDA	~ ()~~~In patient		1						1	Diplopia; Eye disorder; Gait disturbance; Headache; Neuropathy; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81719~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0107034	01/28/1998	OH	44.0	44		M	01/05/1998	pt states back of thighs achy;MD reports reflexes 0 from knees & below pt sent to hosp;spinal tap done numbness to lower back & arms;recv breathing tx for cough & stuffy nose, couldn't take deep breath;exp flu sx, achy, h/a,lethargic;				Y	Y	7			N	11/18/1997	12/15/1997	27	spinal tap	PUB	PUB	Vitamins-multi;Vit E, B & c	NONE	corn husk, ragweed	~ ()~~~In patient	OH98003	1						1	Arthralgia; Dyspnoea; Headache; Hyporeflexia; Influenza; Myalgia; Paraesthesia; Somnolence	FLU3~CONNAUGHT LABORATORIES~7F81917~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0107064	01/29/1998	TX	32.0	32		F	11/13/1997	local redness, swelling & heat;no treatment given;resolved w/in 48hr of vax;									Y	10/21/1997	10/22/1997	1	NA	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	TX98007	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81773~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107065	01/29/1998	TX	25.0	25		F	11/13/1997	localized swelling, heat & redness x 4-5days;resolved;									Y	10/21/1997	10/21/1997	0	NA	PVT	PVT	NONE	NA	NONE	~ ()~~~In patient	TX98006	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81773~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107068	01/29/1998	TX	34.0	34		F	01/05/1998	pt arm became swollen & sore w/in 8hr of vax;arm inflamed from shoulder area to elbow including axillary;pt used cool compresses & OTC Ibuprofen to reduce pain/inflammation;5JAN97 pt visited clinic had brown pigmentation spot;some itching;									Y	12/03/1997	12/04/1997	1	NA	PUB	PUB	NONE	pt denied any	migraine h/a, sinus problems (no rx meds)	pt denies any~ ()~~~In patient	TX98003	1						1	Injection site inflammation; Lymphadenopathy; Oedema peripheral; Pain; Pruritus; Skin discolouration	FLU3~MEDEVA PHARMA, LTD.~E3297GA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~CONNAUGHT LABORATORIES~7E91639~4~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0107088	01/30/1998	PA	22.0	22		M	12/17/1997	lost vision in rt eye;to ER dept @ mercy hosp 5PM 24OCT97;adm to hosp 25OCT97;IV steroids, dx optic neuritis;d/c on pred;vision poor;blood clot devel;tx w/eye drops;seen by MD;				Y	Y	4			N	10/23/1997	10/23/1997	0	MRI various medical consults	OTH	PUB	NONE	NONE	NONE		PA9804	1						1	Blindness; Optic neuritis; Thrombosis; Visual disturbance	FLU3~CONNAUGHT LABORATORIES~7F81793~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0107091	01/30/1998	IA	56.0	56		F	01/22/1998	pt disoriented, nauseous & felt ill;pt exp no feeling on rt side of body;body totally affected w/paralysis;lt leg numb;walks w/sl limp-rt leg very painful diff & painful to walk;legs stiff;no energy;dx diabetic neuropathy;				Y	Y	7		Y	N	10/26/1995	10/26/1995	0	CAT Scan, MRI, Spinal Tap, Brain Function Testing, Daily Blood Testing for 7 days in hosp, Muscle Testing w/needles, etc;	OTH	OTH	Furosomide;Spironolactone:Atenolol;Cardizem CD;Synthroid;Premarin;Zocor;HumulinN;Humulin R;Multivitamin; Vitamin E;Calcium;		diabetes;	~ ()~~~In patient		1						1	Asthenia; Confusional state; Gait disturbance; Nausea; Neuropathy; Pain; Paraesthesia	FLU3~PFIZER\WYETH~5F61126~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0107155	01/30/1998	FL	54.0	54		F	01/26/1998	pt reports pain in rt knee, elbow & wrist w/swelling in nee starting 22JN98;states joints still painful & knee still swollen @ this time;									N	01/21/1998	01/22/1998	1		PUB	PUB	Synthroid;Estrogen patch	NONE	Menopause	NONE~ ()~~~In patient	FL98001	1						1	Arthralgia; Osteoarthritis; Arthralgia; Osteoarthritis	FLU3~CONNAUGHT LABORATORIES~7F81916~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7V81916~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0107159	01/30/1998	MA	30.0	30		M	01/20/1998	devel hives next day & recv DPH @ ER;lips swelled 3 days later;				Y					Y	10/22/1997	10/23/1997	1	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Face oedema; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81793~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107162	01/30/1998	GA	38.0	38		M	01/09/1998	pt recv vax & c/o arm pain on lt deltoid;pain from flu shot;exam of area did not reveal extreme erythema & edema;cool to touch w/palpation;c/o pain in one area w/deep compression;area a little swollen;				Y					Y	10/29/1997	01/04/1998	67	NONE	PUB	PUB		NONE	NONE	NONE~ ()~~~In patient	GA98002	1						1	Injection site oedema; Injection site pain; Pain	FLU3~PFIZER\WYETH~4978213~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0107163	01/30/1998	GA	17.0	17		F	01/05/1998	pt recv vax & reported feeling sick w/aches & flu like sx;told to see MD if sx got worse;									U	01/05/1998	01/05/1998	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	GA98001	1						1	Influenza; Malaise; Myalgia	FLU3~MEDEVA PHARMA, LTD.~E3277GB~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0107164	01/30/1998	PA	3.0	3		F	11/08/1997	pruritic rash @ immun area 6 days p/vax;									Y	10/25/1997	10/31/1997	6		PVT	PUB		sl alopecia areata since beginning of OCT97	episodes of  bronchospasm in past;sx FEB97 estropia	~ ()~~~In patient	PA9801	1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81840~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107165	01/30/1998	PA	5.0	5		F	11/08/1997	rash in the face 6 days p/vax;									Y	10/25/1997	10/31/1997	6		PVT	PUB	Intal;Proventil;AUgmentin	OM	asthma	~ ()~~~In patient	PA9802	1						1	Rash	FLU3~CONNAUGHT LABORATORIES~7F81840~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107166	01/30/1998	PA	34.0	34		F	01/05/1998	17DEC97 c/o onset of swelling & itchiness 3 days past immun;area of c/o under both eyes;status same as 17DEC97;									U	11/10/1997	11/13/1997	3	NA	PUB	PUB	NONE	NONE	allergic to PCN	~ ()~~~In patient	PA9803	1						1	Face oedema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~SMITHKLINE BEECHAM~2398A6~1~IM~LA~HEP B (ENGERIX-B)~1	USA		Influenza
0107134	02/02/1998	MT	67.0	67		M	12/31/1997	17OCT97 had physical-no problems;PSA down to 48;21OCT97 h/a, felt funny;22OCT97 felt worse to MD for lab work;23OCT97 to hosp in kidney failure;blood not coagulating;kidney dialysis 3x wk x 1wk;7NOV97 w/hypertens & n;MD states toxic rxn			Y	Y	Y	15			Y	10/08/1997	10/21/1997	13	PE, labwork	PUB	PUB	Zolodex, Casodex	NONE	Prostate cancer	~ ()~~~In patient	MT98002	1						1	Coagulopathy; Headache; Hypertension; Malaise; Nausea; Overdose; Renal failure	FLU3~CONNAUGHT LABORATORIES~7F81734~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0107172	02/02/1998	NY	66.0	66		F	10/30/1997	rt arm very sore starting early AM 25OCT97 progressed to shoulders across back to lt arm;chills on Saturday;Sunday pain under rt arm until Wednesday;									Y	10/24/1997	10/25/1997	1	NONE	PUB	PUB	Synthroid	NONE	thyroid, cancer of breast 1983;	~ ()~~~In patient	NY98005	1						1	Back pain; Chills; Myalgia; Pain	FLU3~PFIZER\WYETH~4978169~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0944E~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0107175	02/02/1998	MN	38.0	38		F	12/20/1997	pt recv vax 29OCT97 & 30OCT97 4AM woke up itching;6AM noted hives on knees, legs, bottom of hands, wrist, elbows;mild itching;no problem breathing;called MD:3NOV to MD c/o n, legs totally swollen w/hives leg had burning sensation;				Y					Y	10/29/1997	10/30/1997	1		OTH	PVT			asthma	~ ()~~~In patient		1						1	Nausea; Oedema peripheral; Pain; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81894~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107180	02/02/1998	NE	53.0	53		F	01/23/1998	the pain started in the shoulder blade around to the front under the lt arm;the pain moved into the joint in the rotator cuff;pt is currently doing physical therapy & still is unable to raise lt arm;				Y						10/29/1997	10/30/1997	1		PUB	PVT		NONE	NONE	~ ()~~~In patient		1						1	Arthralgia; Back pain; Hypokinesia; Pain	FLU3~CONNAUGHT LABORATORIES~7F81752~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107182	02/02/1998	MT	51.0	51		F	01/15/1998	pt recv vax 15OCT97 in AM lt upper deltoid became severely inflamed;17OCT97 a lump formed under lt axillary w/pain radiating down lt arm;lt wrist swollen & claw-like;painful to flex;extreme muscle weakness;									N	10/15/1997	10/16/1997	1		OTH	PUB	Provera;HCTZ;Estorgen;	NONE	HTN, perimenopausal;NKDA	~ ()~~~In patient	MT98003	1						1	Hypertonia; Injection site inflammation; Myasthenic syndrome; Oedema peripheral; Pain; Skin nodule	FLU3~PFIZER\WYETH~4978146~4~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0107185	02/02/1998	GA	40.0	40		F	01/22/1998	13DEC97 rash to chest & back;16DEC97 malaise, aching all over, sore throat, cough, dizziness-lasted 2 wk;low grade fever;27JAN98 mild rash still  present;									Y	12/08/1997	12/13/1997	5		PVT	PVT	Zoloft;Clarin	NONE	gastric ulcer 1986;bronchitis JUN97;ruptured c6-5 & C6 disc	~ ()~~~In patient	897314054L	1						1	Cough; Dizziness; Malaise; Myalgia; Pharyngitis; Pyrexia; Rash; Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4978188~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|MMR~MERCK & CO. INC.~0328E~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|FLU3~PFIZER\WYETH~4978188~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0107199	02/02/1998	AK	68.0	68		F	09/25/1997	pt recv vax 24SEP97 & 1PM mild progressing to uncomfortable stinging began by 3PM;rt arm immobile, swollen by 1AM;syncope x 30sec;T103 tx w/ASA redness from arm to shoulder & neck area 7AM;T100.0 by 8AM;									Y	09/24/1997	09/24/1997	0	NA	PUB	PUB	oral diabetic, ASA	NONE	polio @ 9yr, rhumatic fever @ 11yr w/heart murmur;diabetes type II, stroke;cataracts;defenerative disc disease 4-5lumbar;	NA~ ()~~~In patient	AK07019	1						1	Hypertonia; Injection site oedema; Oedema peripheral; Pain; Pyrexia; Syncope; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3257FA~2~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0001D~5~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0107200	02/02/1998	AK	67.0	67		F	10/20/1997	1OCT lt arm swollen & hot from top of shoulder to elbow;2OCT striation of red dots 1/2 above elbow;by Monday 6OCt had turned yellow;did not see MD;has had hypersensitive rxn to Td;									Y	10/01/1997	10/01/1997	0	NONE	UNK	UNK					AK97020	1						1	Hypersensitivity; Injection site hypersensitivity; Injection site oedema; Skin discolouration; Skin striae	FLU3~MEDEVA PHARMA, LTD.~E3257FA~7+~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0001D~2~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0107201	02/02/1998	AK	68.0	68		F	10/03/1997	redness, hardness & swelling @ inj site that gradually spread down arm almost to elbow;states hard lump lt arm @ inj site;inj given 11AM & redness & pain started 3PM;used warm soak & motrin;redness has shifted on arm & seem sl beaten;										10/02/1997	10/02/1997	0		PUB	PUB		NONE	codeine	~ ()~~~In patient	AK97021	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Oedema peripheral; Pain; Skin nodule; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3257FA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0994E~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0107202	02/02/1998	AK	62.0	62		M	10/06/1997	pt recv vax & 9hr p/vax nausea & chills-12hr p/inj;felt sick all noc;malaise & h/a  all day 5OCT97;today feels better lt arm reddened above elbow 5-6 (backside of arm) warm to touch;no longer has chills;warm compresses;										10/04/1997	10/04/1997	0		PUB	PUB		NONE	advanced prostate cancer-see's MD q 2mo	~ ()~~~In patient	AK97022	1						1	Chills; Injection site hypersensitivity; Malaise; Nausea; Oedema peripheral; Vasodilatation; Visual disturbance; Vitreous disorder	FLU3~MEDEVA PHARMA, LTD.~E3257FA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~00001D~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0107203	02/02/1998	AK	47.0	47		F	10/22/1997	12hr p/vax had extreme body aching & flushed feeling that lasted 8 hr then fine;48hr p/vax devel welts around inj site;									Y	10/15/1997	10/15/1997	0		PUB	PUB		NONE	NONE	NONE~ ()~~~In patient	AK97023	1						1	Injection site hypersensitivity; Myalgia; Urticaria; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3257FA~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0994E~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0107204	02/02/1998	AK	68.0	68		M	10/23/1997	pt recv vax 22OCT97 & started to ache @ 3AM some sharp pains, some dull extremely sensitive to touch from just above lt elbow to shoulder area;no redness where inj but large amount of swelling;c/o low grade fever, nausea & h/a;3AM till 12N;									Y	10/22/1997	10/23/1997	1		PUB	PUB	Atenolol;Digoxin	NONE	atrial fibrillation 1991;	NONE~ ()~~~In patient	AK97024	1						1	Headache; Hypoaesthesia; Injection site pain; Myalgia; Nausea; Oedema; Pain; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E3257FA~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0994E~2~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0107208	02/02/1998	AR	75.0	75		F	09/23/1997	lt arm painful p/vax remained so;very heavy, difficult to move;early evening gait unsteady, confused, restless sleeping, talking in sleep;incontinent of urine x 2;husband unable to read MD so called 911;T101.5, tachycardia;saw MD in AM;									Y	09/22/1997			EKG WNL	PUB	PUB		NONE	PCN	~ ()~~~In patient	AK97029	1						1	Confusional state; Gait disturbance; Myasthenic syndrome; Pain; Pyrexia; Sleep disorder; Tachycardia; Urinary incontinence	FLU3~MEDEVA PHARMA, LTD.~E3257FA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0001D~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0107209	02/02/1998	AK	1.0	0	1	M	10/09/1997	mom states had temp 2 days before which went away the day of vax;p/shot low grade temp returned & devel fine rash on face body & arms;irritable & missed up sleep pattern;no scratching or c/o itching;rash raised on face;									Y	10/04/1997	10/05/1997	1	NONE	PUB	PUB	albuterol;Cromolyn	temp 103 temp 2 days before vax	asthma, eczema	NONE~ ()~~~In patient	AK97030	1						1	Agitation; Pyrexia; Rash; Rash maculo-papular; Sleep disorder	FLU3~CONNAUGHT LABORATORIES~7F81819~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0091475	02/03/1998	NY	58.0	57		U	02/02/1998	pt recv vax & w/in a few days pt felt weak;pt was adm to hosp on 18OCT96 & dx w/GBS by neurologist;					Y				U	10/08/1996	10/18/1996	10		UNK	UNK				~ ()~~~In patient	CO6910	1						3	Asthenia; Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~6F71255~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Hospitalisation	Influenza
0107140	02/03/1998	WI	67.0	67		M	01/30/1998	pt recv vax 21JAN98 & 24JAN98 GBS devel;pt was transported to hosp;					Y				N	01/21/1998	01/24/1998	3		PUB	PVT				~ ()~~~In patient	CO7831	1						1	Guillain-Barre syndrome; Hypertonia; Hypoaesthesia; Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~7F81883~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0107147	02/03/1998	TX	69.0			F	02/02/1998	w/in 1hr of vax pt devel numbness & tingling in lt face, arm & leg;severe vomiting later occurred;@ ER pt dx w/intercerebral bleed;ER MD states probably no correlation between two events, family believes shot precipitated episode;				Y	Y				U	10/11/1996	10/11/1996	0		UNK	UNK			pt reportedly allergic to codeine;	~ ()~~~In patient	CO6918	1						1	Cerebral haemorrhage; Paraesthesia; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71275~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0107149	02/03/1998	CA				M	01/30/1998	pt recv vax & 3 days /vax pt paralyzed both lower extremities;loss of sphincter tone;				Y				Y	U					UNK	UNK				~ ()~~~In patient	CO7832	1						1	Hypotonia; Paraplegia	FLU3~CONNAUGHT LABORATORIES~5F61114~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0107150	02/03/1998	MI	50.0	50		M	01/30/1998	pt recv vax 14NOV97 & some unspecified time p/vax pt c/o not feeling well x 1wk;10JAN98 c/o 85% hearing loss, 4JAN97 ringing ear approx 5 wk p/vax;concerned w/viral inj;MRI negative;				Y				Y	U	11/14/1997	01/10/1998	57	MRI negative;	UNK	UNK				~ ()~~~In patient	CO7833	1						1	Deafness; Infection; Malaise; Tinnitus; Asthenia; Deafness; Immune system disorder; Infection; Malaise; Sinusitis; Tinnitus	FLU3~CONNAUGHT LABORATORIES~7F81895~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~444069~UNK~~~PNEUMO (PNU-IMUNE)~1|FLU3~CONNAUGHT LABORATORIES~7F81895~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~444069~1~IM~RA~PNEUMO (PNU-IMUNE)~2	USA	Disabling	Influenza
0107151	02/03/1998	OH	57.0	57		F	01/27/1998	w/in 2 days had lethargy & fatigue w/low grade fever;cont till 3JAN97 & then lifted;mammogram in NOV showed lump;primary MD referred pt to MD-surgeon;dx w/breast cancer;26JAN97 pt had bilat modified mastectomy;c/o cholesterol inc since vax;			Y	Y	Y			Y	N	11/04/1997	11/06/1997	2	mamogram;blood work	PUB	PVT	folic acid;MVI;Caltrate;Sulfasalazine	cold	NONE	NONE~ ()~~~In patient		1						1	Asthenia; Breast neoplasm; Hypercholesterolaemia; Pyrexia; Somnolence	FLU3~CONNAUGHT LABORATORIES~7F81916~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0107217	02/03/1998	OH	57.0	57		F	01/27/1998	breast lump noted 4-5 days p/vax breast red & swollen & hot to touch;saw MD & recv ATB;returned to office 4 days later still present & arm now also red, swollen & warm also lt upper arm;biopsy showed no cancer;unsure of cause;				Y					Y	10/21/1997	10/25/1997	4	breast biopsy showed no cancer;	PUB	PVT	Zocor;Tinormen;Fibericon;Primpro;Colrigua	NONE	high BP;allergy dust;	~ ()~~~In patient		1						1	Breast neoplasm; Oedema; Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81904~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~7E91657~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0107237	02/03/1998	NM				F	01/14/1998	tachycardia, syncope, localized itch which had onset of 30-40' & lasted 6 hr;no tx necessary;									Y	11/28/1997	11/28/1997	0	NA	MIL	PVT	NONE	NONE		~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Syncope; Tachycardia	FLU3~PFIZER\WYETH~4978272~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0107244	02/03/1998		49.0	49		U		pt exp sudden onset of pain 14OCT97 in lt arm (deltoid area into lt shoulder) restricting mobility-pain radiated neck down arm-pain progressively worsened;15OCT97 firm lumps in biceps & tricep;dx myofasiculitis d/t allerg rxn;				Y					N	10/13/1997	10/14/1997	1	NA	UNK	PVT	Premainr	NONE	hx allergies:Erythromycin, codeine, contrast dye, demerol & environmental allergies;	NA~ ()~~~In patient		1						1	Hypersensitivity; Hypokinesia; Injection site pain; Myalgia; Neck pain; Pain; Skin nodule	FLU3~PFIZER\WYETH~4978158~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0107372	02/06/1998	GA	43.0	43		F	12/08/1997	pt recv vax 22OCT97 & c/o pain rt arm 27OCT97; returned to hlth unit 3NOV97 w/c/o inc pain;to hlth unit 6NOV97 saw PMD given anti-inflammatory rx;stated may have hit a tendon;				Y					Y	10/22/1997	10/27/1997	5	unk	PUB	PUB	NONE	NONE	NKA	NKA~ ()~~~In patient	GA97156	1						1	Injection site pain; Pain; Tendon disorder	FLU3~PFIZER\WYETH~4978167~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0107376	02/06/1998	SC	41.0	41		F	01/26/1998	pt recv vax & following AM c/o itching, redness & a lump @ the lower inj site;pt c/o h/a, T101 w/chills, arthralgias & bilat chest pain;to MD 24NOV97;dx local rxn w/poss infect;rx pred & keflex;29DEC97 MD office resolved soft tissue nodule;				Y					Y	11/21/1997	11/22/1997	1	NONE	PUB	PUB	Prilosec;Serzone;Premarin;Chlordiazepoxide	NONE	Sarcoidosis, Depression, Spastic Colon, Acid Reflux, mitral valve prolaspe	pt sibling exp similar local rxn to flu shot last yr~ ()~~~In Sibling	SC98004	1						1	Arthralgia; Chest pain; Chills; Infection; Injection site hypersensitivity; Injection site mass; Pruritus; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E3287GH~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0906E~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0107385	02/09/1998	IL	46.0	46		F	01/16/1998	diffuse arthralgias;				Y					Y	10/30/1997	10/31/1997	1	quantitative ANA !:160;1:80;DS-DNA 5;pattern speckled, homogenous;	PVT	PVT	Premarin;HCTZ;Aerobid;Vancenase	NONE	olives, celery, Thimerosol, PCN, Cephalosporins, sulfa, Darvon, grass, shagbark, cabbage;	NONE~ ()~~~In patient		1						1	Antinuclear antibody; Arthralgia	FLU3~PFIZER\WYETH~4978210~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0107392	02/09/1998	MI	62.0	62		F	11/19/1997	severe local rxn;saw MD 9OCT97;blood & fluid were removed by MD on 20CT97;cont med care;				Y					N	10/08/1997	10/08/1997	0	unk	PUB	PUB	unk	unk	unk	unk~ ()~~~In patient	MI98007	1						1	Injection site haemorrhage; Injection site oedema; Injection site reaction	FLU3~PFIZER\WYETH~4978296~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0107361	02/10/1998	LA	40.0	40		M	01/26/1998	pt recv vax 31OCT96 & exp diabetic coma on 5NOV96 & died that day;pt had no hx of diabetes;	Y	11/05/1996							N	10/31/1996	11/05/1996	5	unk	OTH	OTH	unk		no hx of diabetes	~ ()~~~In patient	0010150980002	1						1	Coma; Diabetes mellitus	FLU3~PARKE-DAVIS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0107366	02/10/1998	IL	31.0	31		M	02/06/1998	pt devel flu like sx w/nausea, vomiting dx acute hep A			Y	Y					N	01/09/1998	01/19/1998	10	elevated liver nezymes;8.0 biliruben;IGM positive;hep A antibody;	PVT	PVT	mult meds for HIV infect	HIV positive asymptomatic		~ ()~~~In patient		1						1	Antinuclear antibody; Hepatic function abnormal; Hepatitis; Hyperbilirubinaemia; Influenza; Laboratory test abnormal; Vomiting; Hepatic function abnormal; Hepatitis; Hyperbilirubinaemia; Jaundice; Prothrombin level decreased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~SMITHKLINE BEECHAM~~1~~~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~~1~IM~~VARICELLA (VARIVAX)~2	USA	Life Threatening	Influenza
0107431	02/10/1998	OH	56.0	56		M	01/20/1998	pt recv vax 16OCT97 & exp painful & sore lt arm;flu vax given lt deltoid;-knot seen in inner aspect lt arm;had knot in arm several inches from site of vax;				Y					U	10/16/1997	12/05/1997	50		PUB	PUB	denies	denies	denies	~ ()~~~In patient	OH98005	1						1	Pain; Skin nodule	FLU3~CONNAUGHT LABORATORIES~7F81917~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107457	02/11/1998	VA	48.0	47		F	01/20/1998	pt recv flu vax lt arm pt c/o mild burning, area became red & raised;tx duricef;				Y					Y	01/05/1998	01/15/1998	10	NA	PVT	PVT	NA	NA	MS04 & PCN	NA~ ()~~~In patient	VA98002	1						1	Injection site hypersensitivity; Injection site mass; Pain	FLU3~CONNAUGHT LABORATORIES~7F81746~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107464	02/11/1998	CA				U		gen gradually moving distally in standard-glove distribution, dysesthesias & hyperesthesias;										10/17/1997	10/17/1997	0	nl nerve conduction	PVT	PVT	NA	NONE	NONE	~ ()~~~In patient		1						1	Hypoaesthesia; Paraesthesia; Guillain-Barre syndrome; Hypoaesthesia; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4978150~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4978150~4~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0107718	02/12/1998	MN	62.0	62		F	01/20/1998	pain in lt arm since October;									N	10/06/1997	10/06/1997	0	NONE	PUB	PUB		NONE		~ ()~~~In patient	MN97060	1						1	Pain	FLU3~PFIZER\WYETH~4978168~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0107724	02/12/1998	CA	64.0	64		F	12/08/1997	pt had facial swelling, rash on arms which lasted 3-4 days;									Y	10/16/1997	10/16/1997	0	NONE	PUB	PUB	NONE	diabetes	diabetes	NONE~ ()~~~In patient	CA980017	1						1	Face oedema; Rash	FLU3~CONNAUGHT LABORATORIES~7F81841~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107366	02/13/1998	IL	32.0			M	02/03/1998	pt recv vax 9JAN98 & approx 10 day later 19JAN98 pt was jaundiced & had elevated liver function test, elevated prothrombin time, & elevated bilirubin of 8;pt tested positive for hep A;hosp;dx acute hep A:					Y				N	01/09/1998	01/19/1998	10	19JAN98 BILTOT 8;hep a test positive;	PVT	PVT	HIV medication		HIV positive	~ ()~~~In patient	980038631	1						2	Antinuclear antibody; Hepatic function abnormal; Hepatitis; Hyperbilirubinaemia; Influenza; Laboratory test abnormal; Vomiting; Hepatic function abnormal; Hepatitis; Hyperbilirubinaemia; Jaundice; Prothrombin level decreased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~SMITHKLINE BEECHAM~~1~~~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~~1~IM~~VARICELLA (VARIVAX)~2	USA	Hospitalisation	Influenza
0107727	02/13/1998	LA	46.0	46		F	10/24/1997	reports severe local rxn lt arm swelling of arm & fingers, red & very painful;seen @ local ER & was told to take APAP;later returned to ER & recv cortisone shot;				Y					Y	10/22/1997	10/23/1997	1	NA	PUB	PUB		NONE	NONE	~ ()~~~In patient	LA980203	1						1	Injection site reaction; Oedema peripheral; Pain; Pharyngitis; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3257FA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~CONNAUGHT LABORATORIES~6L87392~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0107680	02/17/1998	WI	71.0	71		F	02/03/1998	muscle aches in arm, buttocks, legs, knees (3-4 days p/red blotches);cont to have sx of aches/stiffness;									N	10/01/1997	10/03/1997	2	not arthritis;not infect	PUB	PUB	Hydroortorsone;Atenol	NONE	NONE	NONE~ ()~~~In patient	WI98036	1						1	Hypertonia; Myalgia; Rash	FLU3~CONNAUGHT LABORATORIES~7F81746~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107682	02/17/1998	OR	33.0	33		M	10/30/1997	20-30min p/vax rt deltoid became sore & sensitive that noc 23OCT inc pain of rt arm w/swelling, redness also rt leg aching;24OCT sweating, chills, fever;sx increasing in intensity on Saturday w/intense h/a & insomnia;				Y					Y	10/23/1997	10/23/1997	0	NONE	OTH	UNK	NONE	NONE	NONE	5-6yr ago pt exp rxn @ 27yr old w/flu vax dose 1;~ ()~~0.00~Patient		1						1	Headache; Hyperhidrosis; Injection site pain; Insomnia; Myalgia; Oedema peripheral; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4978143~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0107692	02/17/1998	CO	41.0			F	11/10/1997	pt recv vax 5NOV97 & noticed welt @ inj site that evening noted gen rash legs, trunk, chest, felt hot, itchy;rash lasted 2 days then faded, itching cont;?fever-did not take temp;									Y	11/05/1997	11/05/1997	0		PUB	PVT	unk	unk	allerg PCN-rash	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~7F81894~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107693	02/17/1998	MI	63.0	63		F	02/16/1998	reddened, tender, warm area @ site of inj LA @ 3cm diameter w/another red area @ 1.5cm diameter lower;no other sx;lasted 2-3 days;used ice/cold compresses;									Y	12/16/1997	12/16/1997	0	NONE	PVT	PVT	Indocin;Premarin	NONE	NKA, pseudogout	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation; Injection site hypersensitivity; Injection site pain; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4978141~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~448168~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~4978141~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~448168~1~IM~RA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0107694	02/17/1998	MI	66.0	66		F	02/16/1998	lt arm (upper) edematous & pruritic w/ 3 diameter erythema lasted couple days;used cool compress & DPH;resolved w/o further tx;									Y	12/01/1997	12/02/1997	1	NONE	PVT	PVT	NONE	NONE	NKA, breast CA hx	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4978141~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~448168~1~SC~LA~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~4978141~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~448168~1~SC~LA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0107706	02/17/1998	OK	75.0	75		M	12/03/1997	c/o arm hurting @ inj site;no redness-no pustules;pt c/o pain in lt shoulder;physical exam reveals a frozen shoulder w/abduction restricted to 80 degrees;tender area over the posterior part of rotator cuff									Y	10/17/1997	10/18/1997	1	NONE	PUB	PUB	BP pill, Zestril	NONE	HTN	NONE~ ()~~~In patient	OK985	1						1	Arthropathy; Hypokinesia; Injection site pain; Pain	FLU3~MEDEVA PHARMA, LTD.~E3277GA~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0107788	02/23/1998	CO	46.0	46		F	10/23/1997	pt recv vax 15OCT97 & 7 days later pt devel deafness in lt ear;pt was seen by ENT specialist;multiple tests, including MRI were performed;results were not provided;reporter indicated event resulted in permanent disability;				Y				Y	N	10/15/1997	10/22/1997	7		PUB	PVT	unk	NONE		~ ()~~~In patient	897314044L	1						1	Deafness	FLU3~PFIZER\WYETH~4978184~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0107805	02/23/1998	NM	62.0	62		M	10/28/1997	weakness-felt shaky p/drinking;									Y	10/27/1997	10/27/1997	0		PUB	PUB			ETHO abuse	~ ()~~~In patient	NM98003	1						1	Asthenia; Tremor	FLU3~PFIZER\WYETH~4978173~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~435957~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0107812	02/23/1998	FL	36.0	36		F		Got vax at son's pediatricians office; 2.5 wks later, feet asleep, then feet, hands, and tongue, eventually no feeling, fell, went to neurosurgery then to neurologist, dx post-viral neuropathy and GBS.  Couldn't walk, drive, write.									Y	10/01/1997	11/02/1997	32	Extensive testing showed elevated protein in spinal fluid.	UNK	UNK						1						1	Guillain-Barre syndrome; Hypokinesia; Neuropathy; Paraesthesia; Paraesthesia oral	FLU3~CONNAUGHT LABORATORIES~7F81791~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107817	02/24/1998	CA	44.0	44		F	10/23/1997	pt recv vax 21OCT97 & c/o tingling feeling @ site;c/o soreness to lt deltoid area; 22OCT97 noticed redness & heat to area; 7x8x4cm redness & sl elevation;									N	10/21/1997	10/22/1997	1		PVT	OTH	MVI, fibers	NONE	hayfever, allergy to papayas-fruit sprays	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Paraesthesia; Vasodilatation	FLU3~PFIZER\WYETH~4978143~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0107819	02/24/1998	CA	42.0	42		F	10/27/1997	noted small reddened area approx 3x4cm on lt upper deltoid;c/o area itching & warm to touch;									Y	10/23/1997	10/24/1997	1		PVT	PUB	hormone pills;levid (for stomach)	NONE	hives, allergic to tomatos, & spices	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4978143~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0107831	02/25/1998	CO	56.0			M	01/28/1998	cellulitis;											10/03/1997			UNK	UNK				~ ()~~~In patient		1						1	Cellulitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0107835	02/26/1998	OH	65.0	65		M	02/25/1998	pt recv vax & devel muscle soreness & stiffness 1mo post vax;pt devel muscle pain & weakness of upper & lower extremities;pt finds it hard to get up out of chair & suffers from bilat shoulder pain;devel acute neuritis w/brachial plexiopathy								Y	N	09/01/1997	10/01/1997	30	NONE	OTH	OTH	Fiorinal/Butalbital, USP;SYmmetrel/Amantadine		Carpal Tunnel synd;carcinoma in porstate;	~ ()~~~In patient	MPI98158	1						1	Hypertonia; Hypokinesia; Myalgia; Myasthenic syndrome; Neuritis; Neuropathy; Pain	FLU3~MEDEVA PHARMA, LTD.~E3367HB~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0107848	02/26/1998	NH	64.0			M	01/27/1998	GBS									N	10/20/1997	11/08/1997	19	NONE	PVT	PUB	NONE	NONE	nONE	~ ()~~~In patient	ME98002	1						1	Guillain-Barre syndrome; Muscle twitching; Neuropathy	FLU3~CONNAUGHT LABORATORIES~7F81820~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107858	02/26/1998	SC	2.0	2	.1	F	02/13/1998	mom reported pt had devel a rash on neck;pt recv flu vax 12FEB98;pt recv 1st dose 8JAN98 w/no rxn;mom reported rxn to PMD since pt is being followed for internal hemangiomas;pt has no fever, vomiting;mom states rash looks like 5th disease;									Y	02/12/1998	02/13/1998	1	NA	PUB	OTH	Tegretol, DPH, PCN, Interferon;pt recv 1st dose of flu vax 8JAN98;	NONE	internal hemagiomas, sz, spleenectomy	NA~ ()~~~In patient	SC98008	1						1	Rash	FLU3~CONNAUGHT LABORATORIES~7F81917~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107859	02/26/1998	MA	49.0	49		M	02/03/1998	pt c/o SOB, difficulty breathing 1/2-1hr p/vax;no hives;inc nervousness;seen in clinic for epi & eval x 3hr;				Y						10/14/1997	10/14/1997	0		PUB	UNK		NONE	PCN allergy	pt exp rxn fall 96 @ 48yr old w/flu vax~ ()~~~In patient	MA98	1						1	Dyspnoea; Nervousness	FLU3~CONNAUGHT LABORATORIES~7F81845~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0107856	02/27/1998	MI	79.0	79		F	02/21/1998	dx w/GBS (principal) secondary: adverse effect viral vaccine;	Y		Y	Y	Y	39	Y		N	10/15/1997	10/16/1997	1		PVT	UNK	Insulin (Humulin);Dyazide;Cardizem;Xanax;	NONE	diabetes, chronic lymphocytic leukemia, HTN	~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~7F81816~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0107861	02/27/1998	OH	66.0	66		M	10/31/1997	pt recv vax 21OCT97 & hot red arm very sore-soreness retained for 1 wk however lesser degree;approx 8cm swelling remains-some evidence of hematoma below area resolving;									Y	10/21/1997	10/22/1997	1	NA	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	OH98015	1						1	Haemorrhage; Myalgia; Oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F87917~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0795E~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0107871	02/27/1998	OH	66.0	65		M	10/17/1997	pain, swelling, redness, hot to touch lt arm shoulder to elbow;				Y						10/15/1997	10/15/1997	0		PUB	PVT	NONE	NA		~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81917~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~08450~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0107873	02/27/1998	IL	39.0	39		F	02/19/1998	facial swelling 9OCT97 persisted for several days;limping, inflammation, tenderness, pain in lt foot, ankle, leg & knee 15OCT97 pred started NOV97;to be dec p/2wk;started on Naprosyn NOV97;ibuprofen;seen by DR 3NOV97;				Y					U	10/08/1997	10/09/1997	1	x-rays-both ankles NOV97 vascular flow study 3NOV97 & blood work CBC bone scan JAN98;MRI 11FEB98;	OTH	PUB	NONE	NONE	chronic cystitis	~ ()~~~In patient	IL98009	1						1	Face oedema; Gait disturbance; Pain; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20017HH~6~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0107878	02/27/1998	MD	50.0	50		F		local swelling @ inj  & arm systemic  sx of fatigue, malaise, myalgias;									Y	11/12/1997	11/14/1997	2	24NOV97 RBC 5.21;WBC 13.7;platelets 476;cholesterol 222;LDL cholesterol 137;VLDL cholesterol 37;phos 5.0	PVT	UNK		exercise induced asthma;		~ ()~~~In patient		1						1	Asthenia; Hypercholesterolaemia; Injection site oedema; Leukocytosis; Malaise; Myalgia; Red blood cell abnormality; Thrombocythaemia	FLU3~PFIZER\WYETH~4978153~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~448189~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0107883	02/27/1998	CA	38.0	38		F	12/01/1997	dizziness, fever 38.8C, lightheaded, h/a, nausea;									N	10/16/1997	10/22/1997	6	NONE	PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Dizziness; Headache; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0107890	02/27/1998	WV	43.0	43		F	10/25/1997	pt recv vax 26OCT97 & noticed a large knot, arm inflamed & red, extremely hot;no tx provided resided in 3-4 days;										10/25/1997	10/25/1997	0		UNK	UNK			NKA;negative smoker;social alcohol;LFT RFT WNL;	~ ()~~~In patient		1						1	Skin nodule; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81931~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0108101	02/27/1998	FL	71.0	71		M	02/23/1998	pt recv vax 19NOV97 & 20NOV97 pt awoke w/swollen tongue & constrictive throat;to MD w/funny talk d/t swollen tongue & w/o resp distress;MD assessment was allergic rxn;pt to ER tx w/med;27NOV97 had second episode referred to MD dx allerg rxn				Y					Y	11/19/1997	11/20/1997	1		PVT	OTH	APAP PM;Napralen;		osteoarthritis;	No relevant data;~ ()~~~In patient	WAES97111810	1						1	Hypersensitivity; Laryngospasm; Tongue oedema	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0906E~1~SC~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0107904	03/02/1998	UT	77.0	77		F	02/26/1998	pt recv vax 25OCT97 & began to tremble all over;pt BP checked & pulse was 120;nurse took pt to ER;				Y	Y	1			Y	10/25/1997	10/25/1997	0	glucose 119;potasisum 3.5;MCV 100.1;lymphocyte 11.4;granulocyte 81.6;TSH 0.00;	PUB	OTH		NONE		~ ()~~~In patient		1						1	Hypercholesterolaemia; Hyperglycaemia; Hypertension; Hypokalaemia; Laboratory test abnormal; Tachycardia; Tremor; Weight decreased	FLU3~CONNAUGHT LABORATORIES~7F81BQ6~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0107937	03/02/1998	KS	28.0	28		F	11/14/1997	started itching in the head concentrated around eyes, lips, face but moved to rest of body entirely;no rash, welts, resp problems;med given;sore & achy & slept all day;									Y	11/12/1970	11/12/1997	9862	NONE	PUB	PUB	Wellbutrin;Albuterol inhaler;Diflucan for thrush	oral thrush	allergy-PCN, cefadioxel, floxin, ceftin, feflex, streptokinase, tape;1994 CHF enlarged heart d/t viral pneumonia 1991-MI;	pt passed out p/oral polio vax & became sick p/typhoid;~ ()~~~In patient	KS97048	1						1	Myalgia; Pruritus; Somnolence	FLU3~PFIZER\WYETH~4978207~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0107938	03/02/1998	KS	62.0	62		F		no redness or swelling @ site of inj but arm hurt 7 or 8 on 0-10 scale for 2 days; 5 days p/vax pt had pain in arm pit;3NOV97 cramps & diarrhea;4NOV97 felt weak, faint, malaise, aching in legs & poss fever;unable to get around;									Y	10/23/1997	11/28/1997	36		PUB	PUB	Lozol;	NONE	NONE	NA~ ()~~~In patient	KS97050	1						1	Asthenia; Diarrhoea; Dizziness; Hypokinesia; Lymphadenopathy; Malaise; Myalgia; Pain; Pyrexia	FLU3~PFIZER\WYETH~4978207~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0107943	03/02/1998	KS	4.0	4		M	12/22/1997	pt recv vax & coughed & vomited small amount;clear mucous then left w/mom;mom states 1-2hr later @ home struggling to breathe;resp approx 80x/min;called MD office & started pt on prelone, DPH & breathing tx;pt slept 14hr;has sinus infect									Y	12/03/1997	12/03/1997	0		PUB	PUB		has a cold	poss asthma	~ ()~~~In patient	KS98002	1						1	Cough; Dyspnoea; Infection; Sinusitis; Vomiting	FLU3~PFIZER\WYETH~4978211~2~IM~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0107952	03/02/1998	PA	62.0	62		F	02/25/1998	extreme swelling @ inj site;									Y	10/09/1997	10/09/1997	0		PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site oedema	FLU3~CONNAUGHT LABORATORIES~7J81745~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107953	03/02/1998	PA	21.0	21		F	02/25/1998	extreme swelling of arm 6 in diameter									Y	10/16/1997	10/16/1997	0		PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~7F81745~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107954	03/02/1998	PA	27.0	27		M	02/25/1998	swelling of arm @ inj site;									Y	10/16/1997	10/17/1997	1		PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site oedema	FLU3~CONNAUGHT LABORATORIES~7F81745~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107961	03/02/1998	TN	37.0	37		F	02/22/1998	pt recv vax 1030AM 14OCT97 & 2PM pt was having problems w/eyes swelling & watering;by 3:00 pt was having diff breathing;pt left to go home & by the time pt arrived @ home was having chest pain (mild w/ inc diff in breathing;DPH & Proventil									Y	10/14/1997	10/14/1997	0		PVT	UNK		asthma	asthma-inhalant allergies;	pt exp local rxn-redness, swelling & Pain w/1cc of flu vax~ ()~~~In patient		1						1	Chest pain; Dyspnoea; Face oedema; Lacrimal disorder	FLU3~CONNAUGHT LABORATORIES~7F81816~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0107984	03/03/1998	TX	35.0			F	11/08/1997	pt devel Bells Palsy									U	10/16/1997	10/20/1997	4		PUB	UNK	NONE	NONE	NONE	~ ()~~~In patient	TX98017	1						1	Facial palsy; Speech disorder	FLU3~PFIZER\WYETH~4978143~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0107985	03/03/1998	TX	35.0			M	11/08/1997	pt devel Bells palsy									U	10/16/1997	10/20/1997	4		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	TX98016	1						1	Facial palsy	FLU3~PFIZER\WYETH~4978143~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0107916	03/04/1998	MT	50.0			M	02/13/1998	neuropathy, arthralgias p/vax;								Y			10/01/1997		EMG, blood tests	UNK	UNK			NONE	~ ()~~~In patient		1						1	Arthralgia; Neuropathy	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0108010	03/04/1998	CA	78.0	78		F	02/28/1998	pt c/o hot, painful, swollen area around inj site;size of swelling 12x8cm;tx w/DPH;				Y					Y	10/16/1997	10/18/1997	2	NONE	PUB	PVT	unk		unk	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4978165~4~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0107968	03/05/1998	TX	24.0	24		M	02/25/1998	pt recv vax 6DEC97 & devel h/a, vomiting, fever on 16DEC97;went to ER on 18DEC97 & was adm w/viral meningitis;				Y	Y	4			Y	12/06/1997	12/16/1997	10	spinal tap-98% lymphocytes & monos;CT scan-neg;	MIL	MIL	NONE	NONE	NONE	~ ()~~~In patient		1						1	Headache; Infection; Laboratory test abnormal; Meningitis; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~7J81910~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0108029	03/05/1998	SC	11.0	11		F	10/20/1997	13OCT97 soreness in legs, sl fever in area;15OCT rash on trunk;15OCT went to dermatologist was told this was a nl side effect for flu;dx cephalosporin;									Y	10/13/1997	10/14/1997	1		PUB	PUB	NA	NONE	+collagen test, hx of allergies, being testing for SLE & other problems;	~ ()~~~In patient	SC97058	1						1	Infection; Injection site hypersensitivity; Injection site pain; Rash; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3287GH~1~~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~MERCK & CO. INC.~0643D~3~~RL~HEP B (RECOMBIVAX HB)~1	USA		Influenza
0108242	03/05/1998	MN	51.0			F	10/01/1997	w/in 24hr of vax pt devel a rash on shoulders & arms, flushing of the face & neck & a buzzing feeling in head;tx w/DPH & recovered 2-3 days;pt attributed this event to an allerg rxn to thimerosal;									Y					OTH	OTH	Synthroid;Prozac;Glucophage	NONE		~ ()~~~In patient	897293024L	1						1	Euphoric mood; Hypersensitivity; Rash; Vasodilatation	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0108243	03/05/1998	NC	33.0	33		F	10/23/1997	pt recv vax & devel an inj site rxn characterized by an area of redness & itching measuring 3 inches in diameter;pt recovered;									Y	01/01/1995	01/01/1995	0	LHRT (allergy test) reportedly negative;	PVT	PVT	NONE	NONE		pt exp redness & itching @ inj site, itching w/flu vax;~ ()~~~In patient	897303007L	1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~~7+~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0108244	03/05/1998	DE	30.0			M	10/22/1997	pt recv vax in 1995 & exp neck stiffness;the stiffness resolved p/approx 2mo;									Y					PVT	OTH	unk	unk		pt exp neck stiffness which persisted as of 22OCT97~ ()~~~In patient	897303012L	1						1	Nuchal rigidity	FLU3~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0108245	03/05/1998	IL	46.0	46		F	11/07/1997	several hr p/vax pt devel an inj site rxn characterized by swelling, redness, warmth & a rash which extended to elbow;pt was treated w/ice & APAP & recovered w/in 3-4 days;									Y	10/01/1995	10/01/1995	0		OTH	OTH	Pred;Methotrexate;Folic acid	unk	Rheumatoid arthritis	~ ()~~~In patient	897344038L	1						1	Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Rash; Vasodilatation	FLU3~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0108246	03/05/1998	PA	60.0			M	11/12/1997	pt recv vax & devel thrombocytopenia;no further info was available @ the date of this report;									U					PVT	OTH	unk	unk		~ ()~~~In patient	898006018L	1						1	Thrombocytopenia	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0108247	03/05/1998	MO	41.0	41		F	10/23/1997	pt recv vax & devel an inj site rxn characterized by an area of redness & swelling measuring 4 inches in diameter;pt recovered;									Y	01/01/1995	01/01/1995	0		OTH	OTH	unk	unk		pt devel an area of redness & swelling, measuring 4 inches in diameter, @ the in~ ()~~~In patient	897318005L	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968144~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0108061	03/06/1998	VA	51.0			F	02/09/1998	pt recv vax 27OCT97 & devel t103.4 & was adm to hosp;pt also found to be hypotensive in ER;blunting of lt costophrenic angle consistent w/lt pleural effusion;UA many bacteria;					Y					10/27/1997	10/28/1997	1	28OCT97 NA 33 (low) all other chem 7 values WNL;WBC 12.0 (high);segs 72;blood cult negative;UA many bacteria;co2-18( low);CH 1.4;30OCT97 WBC 5.3;	UNK	UNK	Propranolol;Diabeta;Spironolactone;Phenergan;Prilosec;		end stage hepatic function-waiting list for transport;no smokine, no ETOH;NKA;hx of lt pleural effusion;diabetes, astham, partial hypertension;intermittent n/v/d x 3-4wk;	~ ()~~~In patient		1						1	Blood creatinine increased; Hypernatraemia; Hypotension; Laboratory test abnormal; Leukocytosis; Pleural effusion; Pyrexia; Urinary tract infection	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0109242	03/06/1998	NJ				U	10/22/1997	several pt devel an inj site rxn p/vax;no further info was available @ date of this report;this is 1 of 2 reports from this facility of inj site rxn p/vax lot# 4978199;									U	10/20/1997	10/21/1997	1		PVT	PVT	unk	unk		~ ()~~~In patient	897314052L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~4978199~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109349	03/06/1998	PA	49.0			F	12/19/1997	w/in 48hr of vax pt devel urticaria on rt arm;the vaccine inj site on lt arm was warm;									U				CBC, T-cells ANA titer: nl;ESR 42;	PVT	OTH	unk	unk	connective tissue disease;unspecified rxn to coxsackievirus years ago	pt mom also exp a similar rxn p/vax (date & MFR unk)~ ()~~~In patient	898009013L	1						1	Red blood cell sedimentation rate increased; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0107155	03/09/1998	FL	54.0	54		F	02/27/1998	pt recv vax 21JAN98 & the next day pt c/o pain & swelling in the knee, elbow & wrist;									N	01/21/1998	01/22/1998	1		PUB	UNK	Synthroid Estrogen patch	NONE	NONE	~ ()~~~In patient	U1998000370	1						2	Arthralgia; Osteoarthritis; Arthralgia; Osteoarthritis	FLU3~CONNAUGHT LABORATORIES~7F81916~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7V81916~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0108103	03/09/1998	NJ	2.0	2	.1	M	03/06/1998	23FEB98 office visit;skin eruptions-confirmed of varicella eruption									Y	10/26/1995	02/23/1998	851	NONE	PVT	PVT	Augmentin	resolving BOM	NKA;does have RAD	~ ()~~~In patient		1						1	Drug ineffective; Infection	FLU3~CONNAUGHT LABORATORIES~5F60014~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0428B~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0108105	03/09/1998	MI	36.0	36		F	03/03/1998	approx 2in red area around vax site;it became red & hot (sore) for 1 1/2-2wk;									Y	10/01/1997			NONE	PUB	UNK	NONE	NONE	codeine	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation; Injection site hypersensitivity; Injection site mass; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4978212~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0108132	03/11/1998	CT	22.0	22		U	02/25/1998	pt was hosp 2 1/2wk p/vax;hospitalization was w/t flu;					Y				U	11/13/1997	12/01/1997	18		OTH	UNK				~ ()~~~In patient	CT9716	1						1	Unevaluable event	FLU3~PFIZER\WYETH~4978195~2~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0108140	03/11/1998	CA	70.0	70		F	02/28/1998	10cm swelling above elbow @ inj site;tx w/DPH;				Y					Y	11/26/1997	11/29/1997	3	NONE	PUB	PVT		unk	unk	unk~ ()~~~In patient		1						1	Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0108154	03/11/1998	CT	27.0	26		U	02/25/1998	pt became ill w/what seemed to be flu sx over christmas 24DEC, 25DEc & 26DEC;very sick w/body aches, sore throat & fever;									U	11/11/1997				OTH	UNK				~ ()~~~In patient	CT9714	1						1	Influenza; Malaise; Myalgia; Pharyngitis; Pyrexia	FLU3~PFIZER\WYETH~4978195~2~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0108155	03/11/1998	CT	44.0	44		U	02/25/1998	sl reaction per pt;pt did not state what the rxn was;									U	11/11/1997				OTH	UNK				~ ()~~~In patient	CT9715	1						1	Unevaluable event	FLU3~PFIZER\WYETH~4978195~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0108156	03/11/1998	CT	33.0	33		U	02/25/1998	p/vax pt was sick for the following 2 days;									U	11/13/1997				OTH	UNK				~ ()~~~In patient	CT9717	1						1	Malaise	FLU3~PFIZER\WYETH~4978195~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0108157	03/11/1998	CT	42.0	42		U	02/25/1998	pt claims to have been sick nearly everyday since recv vax;also claims to have had three bouts w/the flu since recv the shot;									U	11/13/1997				OTH	UNK				~ ()~~~In patient	CT9718	1						1	Influenza; Malaise	FLU3~PFIZER\WYETH~4978195~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0108158	03/11/1998	CT	46.0	46		U	02/25/1998	pt claims to be sick since two days p/vax;									U	11/13/1997				OTH	UNK				~ ()~~~In patient	CT9719	1						1	Malaise	FLU3~PFIZER\WYETH~4978195~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0108159	03/11/1998	CT	23.0	23		U	02/25/1998	3hr p/vax pt had a fever of 101 for 24hr;									U	11/11/1997				OTH	UNK				~ ()~~~In patient	CT9713	1						1	Pyrexia	FLU3~PFIZER\WYETH~4978195~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0108130	03/12/1998	WI	58.0			F	02/25/1998	pt states had flu vax & 26DEC96 devel GBS synd & was hosp for 45 days;									Y		12/26/1996		NONE	UNK	UNK				~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0108196	03/12/1998	CA	51.0	51		M	03/04/1998	pt recv vax & 2hr later hives all over, diarrhea;no SOB to ER rx w/DPH;resolved by next AM;prev flu shots w/o rxn;prev typhoid shot w/o rxn;				Y					Y	11/01/1997	11/01/1997	0	skin test positive to oral typhoid vaccine capsule extract;	MIL	UNK				~ ()~~~In patient		1						1	Diarrhoea; Skin disorder; Urticaria	FLU3~CONNAUGHT LABORATORIES~7J81910~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~BERNA BIOTECH, LTD.~144771A~1~PO~MO~TYPHOID LIVE ORAL TY21A (VIVOTIF)~1	USA	Emergency room visit	Influenza
0108194	03/13/1998	GA	13.0	13		M	01/28/1998	14JAN98 feeling tired, cold pale;15JAN98 fever 103.6 not controlled by APAP;tired, dyspnea, sore throat, stomachache, fatigue;taken to ER dx w/walking pneumonia, loss of appetite;later cough & wheezing;			Y	Y					Y	01/12/1998	01/14/1998	2	CXR, PE, strep cult negative	PUB	PUB	Intal;Eyantab, Albuterol inhaler;Slobid, allergy inj	asthmatic	asthma, allergies, sinusitis (chronic) hayfever	NONE~ ()~~~In patient	GA98008	1						1	Abdominal pain; Asthenia; Asthma; Condition aggravated; Dyspnoea; Nausea; Pneumonia; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E20037KB~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening	Influenza
0108247	03/16/1998	MO	43.0	43		F	10/23/1997	pt recv vax & devel inj site rxn characterized by an area of redness & swelling measuring 4 inches in diameter;pt recovered;									Y	10/01/1996	10/01/1996	0		PVT	PVT	unk	unk	asthma, allergic to Penicillin and Ceclor	pt devel an area of redness & swelling, measuring 4 inches in diameter, @ the in~ ()~~~In patient	897318004L	1						2	Injection site hypersensitivity; Injection site oedema; Vasodilatation; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4968144~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0108527	03/16/1998					F	03/11/1998	pt devel signs of optic neuritis;the sx resolved however over the course of time, new & additional neuro conditions devel;4MAY96 pt recv MRI which was dx of multiple sclerosis;pt had relapsing remitting MS d/t flu vax;also encephalomyelitis									N	10/26/1994	11/02/1994	7	MRI which was diagnostic of MS	PVT	OTH	NONE		NONE	~ ()~~~In patient	00101509800080	1						1	Encephalitis; Laboratory test abnormal; Multiple sclerosis; Neuropathy; Optic neuritis	FLU3~PARKE-DAVIS~00474P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0108676	03/16/1998	UT	44.0	44		F	02/27/1998	pt came to clinic 23FEB98 recv vax & had extreme bradycardia;had influenza x 3;NOV, DEC, JAN98;problems w/leg muscles spasms began APR97-muscle spasms inc DEC97;could no longer walk;walks only w/walker;				Y					U	10/28/1997	11/01/1997	4		PUB	PUB	Proventil inhaler	asthma;	hayfever, asthma	NONE~ ()~~~In patient	UT981806	1						1	Hypertonia; Hypokinesia; Influenza; Myalgia	FLU3~PFIZER\WYETH~4978146~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109076	03/16/1998	CA	20.0			F	10/08/1997	pt recv vax & devel a fever;the fever went as high as 103 & resolved p/3 days;									Y					OTH	OTH	unk	unk		pt devel palpitations, tachycardia, hypertension & dizziness p/vax~ ()~~~In patient	897289010L	1						1	Pyrexia	FLU3~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109077	03/16/1998	MN	56.0	56		F	10/10/1997	12hr p/vax pt devel fever, sweating & chills;pt recovered w/in 12hr;									Y	10/15/1996	10/15/1996	0		PUB	OTH	NONE	NONE		~ ()~~~In patient	897293025L	1						1	Chills; Hyperhidrosis; Pyrexia	FLU3~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109078	03/16/1998	WA	74.0	74		F	10/10/1997	pt recv vax & devel dizziness & nausea;initially dx of a viral infect in the inner ear was made;later dx of Meniere's synd was made;				Y					N	01/10/1997	01/13/1997	3		PVT	OTH	unspecified antihypertensives	NONE	HTN	~ ()~~~In patient	897293026L	1						1	Dizziness; Ear disorder; Nausea; Vestibular disorder	FLU3~PFIZER\WYETH~4968164~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109079	03/16/1998	DE	30.0			M	10/22/1997	pt recv vax & exp neck stiffness;As of 22OCT97 stiffness persisted;									N					PVT	OTH	unk	unk		pt exp neck stiffness which resolved p/approx 2mo~ ()~~~In patient	897303011L	1						1	Nuchal rigidity	FLU3~PFIZER\WYETH~~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109080	03/16/1998	MO	38.0	38		F	10/14/1997	1 or 2 days p/vax pt devel lymphadenitis of the lt side of neck;pt recovered w/o treatment;									Y	10/01/1996	10/10/1996	9		PUB	OTH	unk	unk		~ ()~~~In patient	897303015L	1						1	Lymphadenopathy	FLU3~PFIZER\WYETH~~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109081	03/16/1998	MA				U	10/28/1997	several pt recv vax & devel inj site rxn characterized by redness, swelling, warmth & tenderness;									Y					OTH	OTH	unk	unk		~ ()~~~In patient	897310017L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109083	03/16/1998	CA	62.0			F	10/21/1997	pt recv vax & 5mo post vax pt exp gen aches & pains & muscle weakness;pt indicated that needed to pull self up the stairs & upon bending over to reach for an object on the floor had great diff standing up;sx slowly resolved;									Y					OTH	OTH	unk	NONE		pt recv flu vax each of the prev 3yr w/o adverse exp~ ()~~~In patient	897329034L	1						1	Hypokinesia; Myalgia; Myasthenic syndrome; Pain	FLU3~PFIZER\WYETH~~4~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109084	03/16/1998	MO	78.0	78		M	11/10/1997	approx 1wk p/vax pt devel large red blotches on both forearms;1yr post vax pt cont to have faint blotches;									U	11/01/1996				PVT	OTH	ASA a tablet every other day	NONE	allergic to aminoglycosides, prev influenza vaccination 25yr ago	~ ()~~~In patient	897344039L	1						1	Rash maculo-papular; Vasodilatation	FLU3~PFIZER\WYETH~~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109085	03/16/1998	NY				F	10/27/1997	pt recv vax & devel an inj site rxn characterized redness & induration;pt was seen by MD & recovered;				Y					Y					PVT	OTH	unk	NONE		pt devel an inj site rxn characterized by redness & induration  p/flu vax 97-98~ ()~~~In patient	898040036L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109086	03/16/1998	VA	68.0	68		F	10/29/1997	pt recv vax & MD prescribed unspecified pills to treat a poss urinary tract infect; 2 days later felt a rush of fluid up neck & vomited;pt reported this to MD who told her to stop the pills;									U	10/01/1996	10/01/1996	0		OTH	OTH	Pondimin oral;phenetemine oral;verapamil;chlordiazepoxide;	poss urinary tract infect	obesity, HTN, anxiety	~ ()~~~In patient	898043010L	1						1	Malaise; Vomiting	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0107464	03/17/1998	CA	54.0	53		M	03/03/1998	4-6hr p/vax pt exp numbness, tingling, burning & a crawling sensation all over body;MD was contacted via phone & DPH was prescribed which did not provide relief;pt devel diff moving described as leg will not do what head want to do;dx GBS;				Y					U	10/17/1997	10/17/1997	0		PVT	PVT	Midrin;Elavil	NONE		~ ()~~~In patient	898068006L	1						2	Hypoaesthesia; Paraesthesia; Guillain-Barre syndrome; Hypoaesthesia; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4978150~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4978150~4~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0108666	03/18/1998	MT	50.0	50		M	03/14/1998	pt recv vax 3OCT97 & 5OCT97 numbness rt foot;13OCT97 saw MD tested for diabetes negative;14NOV97 rt ankle stopped working;7JAN98 myelogram & CAT dx peripheral neuropathy, perineal palsy;12FEB98 ?dx vasculitis;								Y	N	10/03/1997	10/05/1997	2	9MAR98 MRI;12MAR98 nerve biopsy;peripheal neuropathe;paraneal palsy;vasculitis;	PUB	PVT	Vasotec;Triamterene	NONE	NONE	NONE~ ()~~~In patient		1						1	Hypokinesia; Neuropathy; Paraesthesia; Paralysis; Vasculitis; Hypokinesia; Hypotonia; Myasthenic syndrome; Neuropathy; Paraesthesia; Hypokinesia; Neuropathy; Paraesthesia; Paralysis; Vasculitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~3	USA	Disabling	Influenza
0108751	03/19/1998	AR	2.0	2	.6	M	11/25/1997	pt to clinic 22OCT97 mom states that pt woke from 2hr nap w/swollen, red rt upper arm;rt upper arm is warm to palpation w/redden elevated bumps;area appear painful to child when touched & pt scratching @ them;				Y					Y	10/16/1997	10/22/1997	6	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	AR97101	1						1	Agitation; Dermatitis bullous; Injection site hypersensitivity; Injection site oedema; Injection site pain; Insomnia; Pruritus; Vasodilatation	DTAP~CONNAUGHT LABORATORIES~7G81489~2~IM~RA~DTAP (TRIPEDIA)~1|FLU3~CONNAUGHT LABORATORIES~7F81803~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0939E~2~IM~RA~HEP B (RECOMBIVAX HB)~1|OPV~PFIZER\WYETH~0761K~2~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~1	USA	Emergency room visit	Influenza
0108754	03/19/1998	OH	60.0	60		F	11/04/1997	redness, warmth, swelling of arm from shoulder to elbow;nausea, fever, dizziness, h/a;									Y	10/29/1997	10/29/1997	0		PUB	PVT		NONE		~ ()~~~In patient	OH98017	1						1	Dizziness; Headache; Nausea; Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81754~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0845D~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0108817	03/20/1998	MA	42.0	42		F	03/15/1998	arm pain in side of pneumovax;arm swollen dx cellulitis rx ATB orally  fever;									Y	10/01/1997	10/01/1997	0		OTH	PVT	Insulin, Klonopin	NONE x/IDDM	IDDM	~ ()~~~In patient		1						1	Cellulitis; Oedema peripheral; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81793~2~A~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0993F~2~A~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0108781	03/23/1998	VA	48.0	48		M	02/15/1998	pt recv vax 16OCT97 & dx w/GBS on 30DEC97 to 17FEB98;prior to GBS dx in good health;no med problems;NKDA;started w/course of ATB on 22DEC97 for pneumonia P pleurisy;			Y		Y			Y		10/16/1997	12/30/1997	75		UNK	UNK				~ ()~~~In patient		1						1	Guillain-Barre syndrome; Pleural disorder; Pneumonia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0108826	03/23/1998	IN	51.0			F	03/18/1998	swelling, pain, erythema of rt arm;dx as sympathetic dystrophy;				Y					N	01/06/1998	01/29/1998	23		PVT	UNK		NONE	tetnaus, PCN, Naprosyn, mild depression, ?	pt exp unk rxn to teatnus;~ ()~~~In patient		1						1	Oedema peripheral; Pain; Rash	FLU3~PFIZER\WYETH~~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0108832	03/23/1998	WA	67.0	67		F	01/15/1998	redness, itching on day of inj area is red, raised, & warm to touch;				Y					Y	01/12/1998	01/12/1998	0	NONE	PUB	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient	WA981423	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4978146~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0950D~1~SC~LA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~7J91913~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0108833	03/23/1998	WA	43.0	43		F	01/13/1998	Friday PM painful lt shoulder;Saturday PM pain extending to lt side of neck into lt arm-Saturday PM very painful lt mid collar bone-3 red lines noted from inj site up neck over inner shoulder;dx lymphangitis;				Y					U	01/09/1998	01/10/1998	1		PUB	PVT				~ ()~~~In patient	WA981420	1						1	Lymphadenopathy; Lymphangitis; Neck pain; Pain; Skin striae	FLU3~CONNAUGHT LABORATORIES~7F81760~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~436822~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0108844	03/23/1998	WA	28.0	28		M	02/05/1998	noc of vax 3FEB98-anxious, insomnia, polyuria;AM 4FEB bilat CVA tenderness, resolved during day, eve of 4FEB lt CVA tenderness, dull ache;AM 5FEB dull ache cont;denies any other GI dx;no CNS c/o;										02/03/1998	02/03/1998	0		PUB	PUB	NONE	Denies	NONE	NA~ ()~~~In patient	WA981428	1						1	Anxiety; Insomnia; Myalgia; Polyuria	FLU3~PFIZER\WYETH~4978146~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEPA~MERCK & CO. INC.~1286E~1~IM~LA~HEP A (VAQTA)~1|IPV~PASTEUR MERIEUX INST.~M1183~UNK~~LA~POLIO VIRUS, INACT. (NO BRAND NAME)~1|JEV~CONNAUGHT LABORATORIES~EJN120C~1~SC~LA~JAPANESE ENCEPHALITIS (J-VAX)~1|MEN~CONNAUGHT LABORATORIES~7H91876~1~SC~RA~MENINGOCOCCAL (MENOMUNE)~1|MMR~MERCK & CO. INC.~0735E~2~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|RAB~PASTEUR MERIEUX INST.~L1130~1~~LA~RABIES (IMOVAX ID)~1|TD~CONNAUGHT LABORATORIES~7C91583~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0108861	03/24/1998	MS	48.0	48		F	03/16/1998	pt presented to Er 2 days p/vax w/erythematous, pruritic swelling approx 10cm x 12cm i size surrounding the inj site on the upper rt triceps area;				Y					Y	10/07/1997	10/08/1997	1	BP 112/82, P 84, R, 20, T98.2;	OTH	OTH	NONE	NONE	allergic: sulfa;no current meds	NONE~ ()~~~In patient		1						1	Hypotension; Hypothermia; Injection site hypersensitivity; Injection site oedema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0108888	03/25/1998		68.0			M		hypersensitivity rxn to flu vax;adm to ER, DPH & cephalexin were prescribed;				Y							12/15/1997			UNK	UNK	Monopril			~ ()~~~In patient		1						1	Hypersensitivity	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0103880	03/26/1998	MD	59.0	59		F	10/20/1997	1 day p/vax pt devel gen itching, hives & flushing;2 days post vax sx worsened & pt devel sl resp diff;pt went to ER & was treated w/IV med;this event was reported directly to FDA by pt;				Y					Y	10/17/1997	10/17/1997	0		OTH	OTH	Zocor;Prempro, ASA, Zyban	NONE		~ ()~~~In patient	897303021L	1						2	Dyspnoea; Pruritus; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4978167~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0104799	03/26/1998	MA	39.0	39		F	11/04/1997	pt recv vax & devel a fever & itching @ the inj site;2 days post vax pt devel a maculopapular rash which started @ the inj site & extended down the arm & across the trunk of body;pt treated symptomatically & recovered;									Y	10/16/1997	10/16/1997	0		PVT	OTH	unk	unk		pt recv vax approx 3-4 inj in past w/o adverse exp~ ()~~~In patient	897329026L	1						2	Injection site hypersensitivity; Pruritus; Pyrexia; Rash maculo-papular	FLU3~PFIZER\WYETH~4978210~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0104966	03/26/1998	CO	49.0	49		F	11/11/1997	8 days p/vax pt reported that exp pain @ the inj site which was radiating to elbow;									U	10/29/1997	11/06/1997	8		PUB	OTH	unk	NONE		~ ()~~~In patient	897344040L	1						2	Injection site pain	FLU3~PFIZER\WYETH~4978165~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0104976	03/26/1998	CO	41.0	41		F	11/06/1997	1 day p/vax pt devel an enlarged lymph node in the lt axilla, approx size of an egg;lymphadenopathy resolved spontaneously;									Y	11/01/1997	11/02/1997	1		OTH	OTH	none	none	allergic to duck embryo, rabies injection	~ ()~~~In patient	897344034L	1						2	Lymphadenopathy; Pain	FLU3~PFIZER\WYETH~4978165~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0105066	03/26/1998	MI	52.0	51		F	11/10/1997	pt recv vax &  began to feel ill & lethargic;later that evening pt exp diff breathing, sweating & pallor;taken to ER & tx w/02;a lung can was performed;pt also devel an irregular heart beat;indigestion & inj site rxn of pain & redness;				Y					Y	11/05/1997	11/05/1997	0		OTH	OTH	unk	unk	fibromyalgia, severe osteoporosis;1wk prior to vax pt exp an intestinal flu characterized by diarrhea & a fever;tx w/lomotil;	~ ()~~~In patient	897349015L	1						2	Arrhythmia; Dyspnoea; Gastrointestinal disorder; Hypoxia; Injection site hypersensitivity; Injection site mass; Injection site pain; Pallor; Arrhythmia; Chest pain; Condition aggravated; Dyspnoea; Gastrointestinal disorder; Hypoxia; Injection site hypersensitivity; Somnolence	FLU3~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~444067~1~IM A~~PNEUMO (PNU-IMUNE)~2|FLU3~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~3|PPV~PFIZER\WYETH~444067~1~IM A~~PNEUMO (PNU-IMUNE)~3	USA	Emergency room visit	Influenza
0105280	03/26/1998	CO	43.0	43		M	11/04/1997	pt recv vax & devel chills & a stinging rash w/vesicular eruptions on the rt posterior neck, lower rt cheek & jaw & chest;3NOV seen by MD noted crusted vesicles;viral cult were positive for varicella zoster;				Y					Y	10/29/1997	10/30/1997	1	3NOV97 viral cult-positive for varicella zoster	MIL	MIL	NONE	NONE		~ ()~~~In patient	897329030L	1						2	Chills; Dermatitis bullous; Infection; Pain; Rash	FLU3~PFIZER\WYETH~4978171~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0105282	03/26/1998	VA	52.0	52		F	11/14/1997	pt recv vax 10NOV97 & exp gen itching;hands & feet became swollen, then all joints became swollen;tx w/DPH & the itching abated;14NOV joints were still swollen;									Y	11/10/1997	11/10/1997	0		PUB	OTH	hormone replacement therapy, niacin	none	mold and house dust allergy; hypertension	~ ()~~~In patient	897337002L	1						2	Insomnia; Oedema peripheral; Osteoarthritis; Paraesthesia; Pruritus	FLU3~PFIZER\WYETH~4978169~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0105857	03/26/1998	UT	10.0	10		M	12/08/1997	Two days after vax, swelling/pain left wrist and hand. Left foot pain and coldness in foot.  Reflex sympathetic dystrophy.				Y					U	11/03/1997	11/05/1997	2		PVT	PVT	Ritalin		Attention deficit disorder	~ ()~~~In patient	897352003L	1						2	Neuropathy; Oedema peripheral; Pain; Peripheral vascular disorder	FLU3~PFIZER\WYETH~4978150~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0106361	03/26/1998	WI	75.0	75		F	12/16/1997	pt recv vax & 2wk post vax pt called MD stating exp pain in legs then exp pain @ the site of pnu-immune 23;pain then spread over entire body;pt reported can hardly stand, walk or turn over in bed;									U	11/01/1997	11/15/1997	14		PUB	OTH	unk	NONE		~ ()~~~In patient	898035002L	1						2	Hypokinesia; Injection site pain; Pain; Hypokinesia; Pain; Gait disturbance; Hypokinesia; Injection site pain; Insomnia; Pain	FLU3~PFIZER\WYETH~4978172~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~4444075~1~IM~LA~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~4978172~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~444075~1~IM~LA~PNEUMO (PNU-IMUNE)~2|FLU3~PFIZER\WYETH~4978172~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~3|PPV~PFIZER\WYETH~444075~1~IM~LA~PNEUMO (PNU-IMUNE)~3	USA		Influenza
0107185	03/26/1998	GA				U	10/16/1997	pt devel an inj site rxn characterized by an area of redness, warmth & pain measuring 2-3inches in diameter p/vax w/lot#4978188;									U	10/13/1997				PVT	OTH	unk	unk		~ ()~~~In patient	897314054L	1						2	Cough; Dizziness; Malaise; Myalgia; Pharyngitis; Pyrexia; Rash; Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4978188~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|MMR~MERCK & CO. INC.~0328E~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|FLU3~PFIZER\WYETH~4978188~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0108105	03/26/1998	MI	36.0	36		F	10/22/1997	pt recv vax & exp an unspecified adverse event p/vax;@ the date of this report, reporter did not know the name of the pt nor what event was exp;this is 1 of 2 pt from this facility to have unspecified adverse exp p/vax lot#4978212;									Y	10/01/1997	10/01/1997	0		OTH	OTH	NONE	unk		~ ()~~~In patient	897303029L	1						2	Injection site hypersensitivity; Injection site pain; Vasodilatation; Injection site hypersensitivity; Injection site mass; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4978212~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0108899	03/26/1998	OH	80.0	80		M	10/29/1997	devel lumps under skin under side of upper rt arm around elbow;the following day the lumps were on lower arm near wrist;area did not appear red, but seemed like a pliable, fluid filled area about 3x3 area;									Y	10/08/1997	10/09/1997	1	NONE	PUB	PVT		has had hx colon cancer & being eval d/t inc RFL pain	hx colon cancer, liver	~ ()~~~In patient	OH98020	1						1	Skin nodule	FLU3~CONNAUGHT LABORATORIES~7F81754~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0845D~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0108923	03/26/1998	WI	73.0	73		F	11/12/1997	extreme fatigue, muscles/joint pain, h/a, gastrointestinal upset, constipation, diarrhea, chills-feeling cold, dry cough, fever;22OCT97 exp extreme diff breathing & dizziness;pt felt had the flu;. All these symptoms started on Oct 6, 1997 when the influenza, pneumococcal vaccines were administered. Her health continued to deteriorate and on Oct 22, 1997 in the evening she experienced extreme difficulty breathing and then later dizziness. At this point she was taken to the Emergency room of hospital. Felt nauseated at home- threw up at hospital. Asthenia, headache, diarrhea, no dyspnea, myalgia, dyspepsia, chills fever, flu symd, arthralgia, constipation, cough inc, reaction aggrav.	Y	10/31/1997		Y	Y	10			N	10/06/1997	10/22/1997	16	2wk later on 22OCT97 felt resp diff breathing merthiolate, thimerosal rxn;	UNK	UNK	Dyazide-water pill	NONE	HTN, dizziness;			1						1	Arthralgia; Asthenia; Chills; Condition aggravated; Constipation; Cough; Diarrhoea; Dizziness; Dyspepsia; Dyspnoea; Dyspnoea; Fatigue; Feeling cold; Headache; Influenza; Influenza like illness; Myalgia; Nausea; Pyrexia; Pyrexia	FLU3~PFIZER\WYETH~4978172~2~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~444071~1~~LA~PNEUMO (PNU-IMUNE)~1	USA	Results in Death	Influenza
0108971	03/26/1998	VA	63.0	63		F	10/28/1997	12hr p/vax pt exp bronchospasm w/SOB & coughing;also devel an inj site rxn characterized by redness & swelling @ the site of vax;went to ER & noted to be in severe resp distress;pt hosp & treated w/nebulized albuterol, aminophyylline;				Y	Y	2			Y	10/23/1997	10/24/1997	1	arterial blood gast on 2 liters of oxygen: pH=7.356;PC02=47;PO2=64.8	PVT	PVT	NONE	NONE	hx of smoking, quit 9OCT97;		897303042L	1						1	Asthma; Cough; Dyspnoea; Hypoxia; Injection site hypersensitivity; Injection site oedema; Lung disorder; Asthma; Cough; Dyspnoea; Injection site hypersensitivity; Injection site oedema; Lung disorder; Respiratory disorder	FLU3~PFIZER\WYETH~4978153~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~1~IM~~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~4978153~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~~1~IM A~~PNEUMO (PNU-IMUNE)~2	USA	Hospitalisation	Influenza
0109109	03/26/1998	PA	1.6	1	.6	F	11/05/1997	Pt inadvertently received a 2.5 ml inject of Flu Shield (97-97 formula). Exp pain during the injection and recovered.									Y	11/05/1997	11/05/1997	0		PVT	PUB	None	None		~ ()~~~In patient	897318006L	1						1	Pain	FLU3~PFIZER\WYETH~4978144~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109110	03/26/1998	AZ	60.0	60		F	11/26/1997	1 month following a flu vax (mfr unknown), pt inadvertently received inject of Flu Shield, (97-98 formula). Within 2 days, pt devel fever and chills.									Y	11/23/1997	11/25/1997	2		PUB	PUB	UNK	None		~ ()~~~In patient	897343004L	1						1	Chills; Pyrexia	FLU3~PFIZER\WYETH~4978268~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~448191~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0109111	03/26/1998	CA	21.0			F	10/08/1997	1 hr p/vax pt devel palpitations & dizziness; 4 hr after vax, was seen by MD. Heart rate 116 beats/min. BP 130/90 mmHg. Given oral Benadryl. As of 10/10/97 heart rate is still greater than 100.				Y					U	10/08/1997	10/08/1997	0		OTH	OTH	Unknown	Unknown		Pt T 103 X 3 days. Flu vax 96-97 MFR unk. MCN 8-97289-010L.~ ()~~~In patient	897289009L	1						1	Dizziness; Hypertension; Palpitations; Tachycardia	FLU3~PFIZER\WYETH~4978156~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109112	03/26/1998	PA				M	10/10/1997	Pt devel swelling upper lip 1 day following vax. Seen by MD and treated with Benadryl. Swelling began to resolve on 10/09/1997				Y					U	10/08/1997	10/09/1997	1		OTH	OTH	Hydrochlorothiazide	None	Hypertension	~ ()~~~In patient	897289011L	1						1	Face oedema	FLU3~PFIZER\WYETH~4978182~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109113	03/26/1998	IN				U	10/01/1997	Pt devel red, raised rash at inject site. Reporter indicates that approx 25-30 of the 45 employees that received vax, devel a rash at the inject site. Additional reports to be generated.									U					OTH	OTH	Unk	Unk		~ ()~~~In patient	897289012L	1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~4978190~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109114	03/26/1998	AL				U	10/01/1997	1 hr p/vax pt devel inject site rxn of redness, pain & itching. Recovered within 24-48 hr Reporter indicates approx 60 patients exp same rxn, they are not presently identifiable.									Y					PVT	OTH	Unk	Unk		~ ()~~~In patient	897289013L	1						1	Injection site hypersensitivity; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~4978213~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109115	03/26/1998	MO				U	10/03/1997	Several pt devel redness at the inject site following the vax. Additional reports to be generated.									U					OTH	OTH	Unk	Unk		~ ()~~~In patient	897289015L	1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109116	03/26/1998	PA				U	10/02/1997	Within 24 hr of vax pt devel inject site rxn of redness, swelling & soreness. As of Oct. 2, 1997 a red ring remained. Reporter indicates that of 300-500 vaccinees, 25 exp this rxn. Add.reports to follow.									U	09/29/1997	09/30/1997	1		PUB	PVT	Unk	Unk		~ ()~~~In patient	897289016L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4978163~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109117	03/26/1998	IL	46.0	46		M	10/03/1997	Pt received Flu Shield(97-98 formula) & Pnu-Imune23 mixed & injected into 1 site. Devel fever, flu-like symptoms, inject site rxn of redness, raised bumps. Reporter recommends vax's not be mixed, but injected separately.				Y					Y	09/24/1997	09/26/1997	2		MIL	PUB	Dilantin, Lansoprazole, Ketoconazole, Lisinopril	none	hypertension, sleep apnea and seizure activity	~ ()~~~In patient	897289017L	1						1	Influenza; Injection site hypersensitivity; Pyrexia; Influenza; Injection site hypersensitivity; Pyrexia	FLU3~PFIZER\WYETH~4978296~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~443660~1~IM~LA~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~4978296~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|OPV~PFIZER\WYETH~443660~1~IM~LA~POLIO VIRUS, ORAL (ORIMUNE)~2	USA	Emergency room visit	Influenza
0109118	03/26/1998	NC				U	10/02/1997	Within 24 hr of vax, pt devel redness, swelling itching & pain at inject site. Reporter indicates 7 pts exp this rxn. Additional reports to be generated.									U					PVT	OTH	Unk	Unk		~ ()~~~In patient	897289020L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~UNK~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109119	03/26/1998	MO				U	10/07/1997	After vax, pt devel hives, itching at inject site. Treated with Benadryl and applied ice. Reporter indicates that of 100, 15 devel this rxn. Additional reports to be generated.									U	10/03/1997				PVT	PVT	Unk	UNK		~ ()~~~In patient	897289021L	1						1	Injection site hypersensitivity; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4978206~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109120	03/26/1998	CO	39.0	39		F	10/08/1997	Pt devel inject site rxn of redness, the size of her hand. Also pain during injection which really stung.									U	10/07/1997	10/07/1997	0		PVT	PVT	Prenatal Vitamins	None		~ ()~~~In patient	897289022L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4978140~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109121	03/26/1998	TX	34.0	34		F	10/10/1997	Pt exp burning sensation left arm and shoulder 10 min following receipt of vax.									Y	10/09/1997	10/09/1997	0		PVT	OTH	none	none	allergic to penicillin, sulfa, tetracycline, molds, grasses	~ ()~~~In patient	897293008L	1						1	Pain	FLU3~PFIZER\WYETH~4978140~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109122	03/26/1998	MS				U	10/10/1997	One day following vax, pt devel inject site rxn of mild cellulitis, which was resolving 3 days later.									N	10/07/1997	10/08/1997	1		PUB	OTH	Unk	NONE		~ ()~~~In patient	897293009L	1						1	Cellulitis; Injection site hypersensitivity	FLU3~PFIZER\WYETH~4978142~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109123	03/26/1998	NY				F	10/10/1997	Pt devel inject site rxn of induration and redness. Reporter indicates that of 20 employees vax, 9 exp similar rxn. Additional reports to be generated.									Y	10/08/1997	10/08/1997	0		OTH	PVT	None	none		~ ()~~~In patient	897293010L	1						1	Injection site hypersensitivity; Injection site mass; Pruritus	FLU3~PFIZER\WYETH~4978139~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109124	03/26/1998	MT	46.0	46		F	10/06/1997	Immed following vax, pt exp arm pain from shoulder to hand. Pain resolved within 30 min.This is 1of 3 employees to exp arm pain following vax with lot #4978143. Reporter notes: 25 gauge, 1 in. needle used to administer vax.									Y	10/06/1997	10/06/1997	0		OTH	PVT	Unk	None		~ ()~~~In patient	897293011L	1						1	Pain	FLU3~PFIZER\WYETH~4978143~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109125	03/26/1998	PA				U	10/07/1997	Pt devel neck pain & stiffness & hot rashes at inject site. This is 1 of 6 pts receiving vax 12-24 hr later devel similar rxn.									Y					PVT	PVT	Unk	None		~ ()~~~In patient	897293012L	1						1	Hypertonia; Injection site hypersensitivity; Neck pain; Vasodilatation	FLU3~PFIZER\WYETH~4978163~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109126	03/26/1998	PA				U	10/07/1997	12-24 after vax, pt devel neck pain, stiffness and hot rashes at the inject site. This is 1 of 6 pts receiving vax that exp similar rxn.									Y					PVT	PVT	Unk	None		~ ()~~~In patient	897293013L	1						1	Hypertonia; Injection site hypersensitivity; Neck pain; Vasodilatation	FLU3~PFIZER\WYETH~4978163~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109127	03/26/1998	PA				U	10/07/1997	12-24 hr after vax, pt devel neck pain, stiffness, and hot rashes at inject site.									Y					PVT	PVT	Unk	None		~ ()~~~In patient	897293014L	1						1	Hypertonia; Injection site hypersensitivity; Neck pain; Vasodilatation	FLU3~PFIZER\WYETH~4978163~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109128	03/26/1998	PA				U	10/07/1997	12-24 hr after vax, pt devel neck pain, stiffness and hot rashes at the inject site. This is 1 of 6 pts at this site to have similar vax rxn									Y					PVT	PVT	Unk	None		~ ()~~~In patient	897293015L	1						1	Hypertonia; Injection site hypersensitivity; Neck pain; Vasodilatation	FLU3~PFIZER\WYETH~4978163~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109129	03/26/1998	PA				U	10/07/1997	12-24 hr after vax, pt devel neck pain, stiffness and hot rashes at the inject site. This is 1 of 6 pts at this site which after vax had similar rxn.									Y					PVT	PVT	Unk	None		~ ()~~~In patient	897293016L	1						1	Hypertonia; Injection site hypersensitivity; Neck pain; Vasodilatation	FLU3~PFIZER\WYETH~4978163~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109130	03/26/1998	PA				U	10/07/1997	12-24 hr. after vax pt devel neck pain, stiffness & hot rashes at the inject site. This is 1 of 6 pts at this site which had similar rxn.									Y					PVT	PVT	Unk	None		~ ()~~~In patient	897293017L	1						1	Hypertonia; Injection site hypersensitivity; Neck pain; Vasodilatation	FLU3~PFIZER\WYETH~4978163~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109131	03/26/1998	MD	50.0	50		F	10/13/1997	4 hr.after vax, pt devel maculopapular rash on anterior torso & upper thighs. A few papules on forearms.Reporter noted pt finished 7 day course of amoxicillin that AM.				Y					Y	10/09/1997	10/09/1997	0		PVT	PVT	Unk	Upper respiratory infection		~ ()~~~In patient	897295015L	1						1	Pruritus; Rash maculo-papular	FLU3~PFIZER\WYETH~4978162~7+~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109132	03/26/1998	NJ				U	10/16/1997	A number of pts experienced injection site pain within a few hr of receiving Flu Shield (1997-98 Formula). The reporter was unable to specify the number of patients who experienced this event. Additional reports will be generated when identifying info is provided.									U	10/01/1997	10/01/1997	0		PVT	PVT	Unk	Unk			897295016L	1						1	Injection site pain	FLU3~PFIZER\WYETH~4978269~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109133	03/26/1998	MD	2.0	2	.9	M	10/17/1997	1 day following vax pt devel generalized hives. Treated with Benadryl and recovered. Reporter notes: Pt finished 10 days of Ceclor 24 hr prior to vax. Began using new shampoo 3 days prior to vax.									Y	10/14/1997	10/15/1997	1		PVT	PVT	None	None	Recent streptococcal infection, no known drug allergies	~ ()~~~In patient	897295017L	1						1	Urticaria	FLU3~PFIZER\WYETH~4978178~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109134	03/26/1998	NE	57.0	57		U	10/16/1997	Pt was receiving warfarin therapy, given vax during week of Oct 5, 1997. Oct 13, Pt's prothrombin time was found to be elevated									U	10/01/1997	10/13/1997	12		PVT	OTH	Warfarin Sodium	Unk		~ ()~~~In patient	897295018L	1						1	Prothrombin level increased	FLU3~PFIZER\WYETH~4978155~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109135	03/26/1998	OR				U	10/13/1997	Within 24 hr of vax, several pt devel lymphadenopathy & inject site rxn of redness, soreness, itching. Reporter is unable to identify any of these pts.									U	10/10/1997	10/10/1997	0		OTH	PUB	Unk	None		~ ()~~~In patient	897295019L	1						1	Injection site hypersensitivity; Injection site pain; Lymphadenopathy; Pruritus	FLU3~PFIZER\WYETH~4978174~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109136	03/26/1998	MN	57.0	57		F	10/15/1997	1 day following vax, pt devel swelling, redness and tenderness at inject site. 2 days post vax, pt devel morbilliform-type rash on her trunk, arms & thighs. Rash described as What you'd see with Amoxicillin.				Y					Y	10/09/1997	10/10/1997	1		OTH	PVT	Cardizem CD 120 MG	None		~ ()~~~In patient	897295020L	1						1	Injection site hypersensitivity; Injection site oedema; Pain; Rash	FLU3~PFIZER\WYETH~4978296~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109137	03/26/1998	GA				U	10/16/1997	One of 3 pts that devel inject site rxn with redness, warmth & pain with 2-3 inches in diameter, after vax. Lot # 4978188.									U	10/13/1997				PVT	OTH	Unk	Unk		~ ()~~~In patient	897295021L	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4978188~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109138	03/26/1998	LA	42.0	42		F	10/14/1997	Five hr. post vax pt devel inject site rxn with redness,warmth & pain.Within 5-7 days,inject site size inc to that of a 50 cent piece. Inject site pain down arm with numbness in fingers. Tx w/ compresses & analgesics;									Y	10/09/1997	10/09/1997	0		OTH	OTH	unk	NONE		~ ()~~~In patient	897295022L	1						1	Injection site hypersensitivity; Injection site pain; Paraesthesia; Vasodilatation	FLU3~PFIZER\WYETH~4978185~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109139	03/26/1998	NY	67.0	67		M	10/16/1997	Pt devel diabetic neuropathy feet & hands 1995. Tx unsuccessfully w/meds. 1 day post vax, inc sensitivity of fingers,reduced numbness of feet,Cont to inc x3 days,numbness hands/feet returned by Oct 15.									Y	10/10/1997	10/10/1997	0		MIL	MIL	Humulin N 50 units AM, 40 units PM	None	Insulin dependent diabetes mellitus 1986.Diabetic neuropathy feet hands since 1995.	~ ()~~~In patient	897295023L	1						1	Chills; Hyperaesthesia; Malaise; Paraesthesia; Vasodilatation	FLU3~PFIZER\WYETH~4978169~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109140	03/26/1998	NC	60.0			F	10/15/1997	After vax pt devel induration inject site. Induration resolved. 3 days later pt devel axillary lymphadenopathy inj arm.									Y					PVT	PVT	Unknown	None		~ ()~~~In patient	897295024L	1						1	Injection site mass; Lymphadenopathy	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109141	03/26/1998	MI	59.0	59		F	10/16/1997	1 day post vax, pt devel inject site rxn of swelling, redness, soreness & indentation of 20 mm across. All symptoms resolved but indentation which persisted as of Nov. 17.									U	10/06/1997	10/07/1997	1		PUB	OTH	Unk	None		~ ()~~~In patient	897295025L	1						1	Injection site atrophy; Injection site hypersensitivity; Injection site oedema; Injection site pain; Injection site hypersensitivity; Injection site mass; Injection site oedema; Pain	FLU3~PFIZER\WYETH~4978174~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4978174~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0109142	03/26/1998	NY	65.0			F	10/17/1997	Pt devel inject site rxn. No further info available									U					PVT	OTH	Unknown	None		~ ()~~~In patient	897295026L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109143	03/26/1998	CO	33.0	33		F	10/17/1997	Pt exp pain at inject site min after vax. Pain persisted for 2 days. Reporter notes: Inj given w/1.5 in. needle. Reporter stated other pts exp same rxn but was unable to track these pts.									Y	10/01/1997	10/01/1997	0		OTH	OTH	Unk	None	None	~ ()~~~In patient	897295027L	1						1	Injection site pain	FLU3~PFIZER\WYETH~4978172~6~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109144	03/26/1998	FL	35.0	35		F	10/16/1997	Pt has history allergy to gentamicin & thimerosal, devel inject site rxn within 24 after vax. Redness, swelling resolved without tx after 1 day.									Y	10/07/1997	10/08/1997	1		OTH	OTH	oral contraceptive	None	Genamicin, Thimerosal.	~ ()~~~In patient	897295028L	1						1	Conjunctivitis; Eye disorder; Face oedema	FLU3~PFIZER\WYETH~4978158~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109145	03/26/1998	NC				U	10/16/1997	Pt devel inject site rxn of swelling,erythema after vax. This pt has had inject of flu vax each of the past few yr. This is 1 of 6 elderly pts who devel inject site rxn.									U					PUB	OTH	unknown	Unknown		~ ()~~~In patient	897296003L	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109147	03/26/1998	NC				U	10/16/1997	1 of 6 elderly pts to receive vax & devel inject site rxn.with swelling & erythema. Pt has had flu vax each of the past few yr.									U					PUB	OTH	Unk	Unk		~ ()~~~In patient	897296005L	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109148	03/26/1998	NC				U	10/16/1997	1 of 6 elderly pts devel inject site rxn with systems of swelling & erythema. Pt has received flu vax each of the past few yr.									U					PUB	OTH	Unknown	Unknown		~ ()~~~In patient	897296006L	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109149	03/26/1998	NC				U	10/16/1997	1 of 6 elderly pts who devel inject site rxn following flu vax of swelling & erythema. Pt has had flu vax each yr for the past few yr.									U					PUB	OTH	Unk	UNK		~ ()~~~In patient	897296007L	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109150	03/26/1998	NC				U	10/16/1997	1 of 6 elderly pts who devel inject site rxn after flu vax with swelling & erythema. This pt has had flu vax each yr for several yr.									U					PUB	OTH	Unk	Unk		~ ()~~~In patient	897296008L	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109151	03/26/1998	TX				U	10/14/1997	w/in 24hr of vax pt devel gen urticaria;pt was treated w/oral pred;this is 1 of 3 pt from this facility of adverse exp p/vax;									U					PUB	PVT	unk	NONE		~ ()~~~In patient	897296009L	1						1	Urticaria	FLU3~PFIZER\WYETH~4978160~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109152	03/26/1998	TX				U	10/14/1997	w/in 24hr of vax pt devel gen urticaria;this is 1 of 3 reports from this facility of an adverse exp p/vax;									U					PUB	PVT	unk	NONE		~ ()~~~In patient	897296010L	1						1	Urticaria	FLU3~PFIZER\WYETH~4978160~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109153	03/26/1998	TX				U	10/14/1997	w/in 24hr of vax pt devel low grade fever, malaise, h/a, myalgia & an inj site rxn characterized by redness, warmth & induration;this is 1 of 3 pt from this facility who had adverse exp p/vax;reporter unable to specify the # of pt w/exp									U					PUB	OTH	unk	NONE		~ ()~~~In patient	897300029L	1						1	Headache; Injection site hypersensitivity; Injection site mass; Malaise; Myalgia; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4978160~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109154	03/26/1998	TX				M	10/21/1997	pt devel cellulitis p/vax which was mixed in the same syringe & injected into one site;this is 1 of 2 pt from this site to devel cellulitis p/vax;MEDICAL AFFAIRS NOTE: it is recommended that flu vax & pnu-immune be inj into different sites;									U	10/15/1997				OTH	OTH	unk	unk		~ ()~~~In patient	897301006L	1						1	Cellulitis; Cellulitis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0109155	03/26/1998	MI	39.0			F	10/14/1997	immed p/vax pt devel an inj site rxn characterized by pain, redness & itching;the next day an 8cm area of redness, swelling & warmth had devel;the itching had subsided;reporter states 1inch needle was used to inj vax into the thigh;									U	10/13/1997	10/13/1997	0		PVT	PVT	NONE	NONE		~ ()~~~In patient	897303016L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4978212~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109156	03/26/1998	NV	38.0			U	10/14/1997	1 day p/vax pt devel an inj site rxn characterized by a 2-inch by 3-in area of redness, swelling & warmth;									U	10/08/1997	10/09/1997	1		MIL	MIL	NONE	NONE		~ ()~~~In patient	897303017L	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109157	03/26/1998	MN				U	10/13/1997	pt recv vax & devel an inj site rxn characterized by redness, swelling & soreness w/in 24hr of vax;this is 1 of 4 pt from this facility to devel a rxn p/vax;									U	10/01/1997	10/01/1997	0		PUB	OTH	unk	NONE		~ ()~~~In patient	897303018L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4978165~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109158	03/26/1998	IN				U	10/07/1997	w/in 18-24 hr p/vax several pt devel inj site rxn characterized by a 3-4inch area of warmth, itching & induration;pt given APAP & hydrocortisone cream;reporter unable to specify # of pt who exp this event;addtl reports will be generated;									U	10/02/1997	10/03/1997	1		PVT	PVT	NONE	UNK		~ ()~~~In patient	897303019L	1						1	Injection site mass; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4978203~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109159	03/26/1998	UT	86.0			M	10/06/1997	1 day p/vax pt devel swelling of the face, neck & gums, but not the tongue;the swelling persisted as of 6OCT97;4 days post vax;									U	10/02/1997	10/03/1997	1		PUB	OTH	unk	NONE		~ ()~~~In patient	897303020L	1						1	Face oedema; Oedema	FLU3~PFIZER\WYETH~4978167~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109161	03/26/1998	CO	80.0	80		M	10/22/1997	pt recv vax 17OCT97 & that evening pt exp itching of lower legs, back & lt side of chest;application of hand lotion did not relieve the itching;application of neosporin ointment relieved the itching of back & chest p/10hr;									U	10/17/1997	10/17/1997	0		PVT	PVT	Axid;Lupron, Cordarone;	unk	prostate cancer, circulatory problems, unspecified cardiac arrhythmia;	~ ()~~~In patient	897303022L	1						1	Pruritus	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109162	03/26/1998	MD				F	10/20/1997	2 days p/vax pt noticed swelling in rt armpit;pt saw MD who did not think the swelling was vax related;the swelling resolved p/several days;6 days post vax pt noted facial swelling, particularly around the eyes & gritty feeling on face;				Y					U	10/09/1997	10/11/1997	2		OTH	OTH	unk	unk		~ ()~~~In patient	897303023L	1						1	Face oedema; Lymphadenopathy; Skin disorder	FLU3~PFIZER\WYETH~4978162~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109163	03/26/1998	NC	56.0	56		M	10/17/1997	pt stated became delirious approx 6hr p/vax (MFR unk);				Y					U	10/16/1997	10/16/1997	0		PUB	PUB	Amitriptyline;Colace, Relafen, Phenergan, Bentyl, Valium;	prostate cancer	prostate cancer	~ ()~~~In patient	897303024L	1						1	Delirium	FLU3~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109164	03/26/1998	LA				M	10/22/1997	pt was exp back pain @ the time of vax;the back pain worsened post vax;									U	10/14/1997				PUB	OTH	unk	back pain		~ ()~~~In patient	897303025L	1						1	Back pain; Condition aggravated	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109165	03/26/1998	PA	65.0	65		M	10/20/1997	pt recv vax 17OCT97 & next morning felt fatigued;about 43hr later awakened by severe chest pain radiating to the shoulder;stated felt like was exp a heart attack;required for pain relief;also devel hoarseness, h/a, n, weakness;									Y	10/17/1997	10/18/1997	1		OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient	897303026L	1						1	Asthenia; Chest pain; Headache; Laryngitis; Nausea	FLU3~PFIZER\WYETH~4978198~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109166	03/26/1998	PA	58.0	58		F	10/22/1997	2 days p/vax pt devel an inj site rxn characterized by induration, swelling, itching, redness & warmth;pt recovered;this is 1 of 8 pt of this facility to devel an inj site rxn p/vax;									Y	10/20/1997	10/22/1997	2		PVT	OTH	Ogen, Synthroid, Provera	NONE	hyperthroidism	~ ()~~~In patient	897303027L	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4978139~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109167	03/26/1998	MI	49.0	49		F	10/22/1997	pt exp an unspecified adverse event following vax;@ the date of this report, the reporter did not know the name of pt, nor what event was exp;this is 1 of 2 pt from this facility to have unspecified adverse exp p/vax lot#4978212									Y	10/01/1997	10/22/1997	21		OTH	OTH	NONE	UNK		~ ()~~~In patient	897303028L	1						1	Chills; Dysphonia; Influenza; Laryngospasm; Neck pain; Pain	FLU3~PFIZER\WYETH~4978212~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109169	03/26/1998	LA	40.0	40		F	10/23/1997	pt exp gen body aches p/vax 6 days later, devel a rash on abd which progressed w/in a few hr to gen welts;pt was seen by MD who administered IM Celestone or oral zyrtec;this is 1 of 2 pt from this facility to devel an allerg rxn p/vax;				Y					Y	10/16/1997	10/16/1997	0		PVT	OTH	Levothyroid;Estace	NONE	hx of ITP;hypothyroidism;allergies to codiene & erythromycin;	~ ()~~~In patient	897303031L	1						1	Hypersensitivity; Myalgia; Rash; Urticaria	FLU3~PFIZER\WYETH~4978140~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109170	03/26/1998	TX				U	10/21/1997	pt recv vax & devel inj site rxn p/vax;									U	10/15/1997				OTH	OTH	unk	unk		~ ()~~~In patient	897303032L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109171	03/26/1998	TX				U	10/21/1997	pt recv vax & devel an inj site rxn p/vax;this is 1 of 4 pt from this facility to exp this rxn;									U	10/15/1997				OTH	OTH	unk	unk		~ ()~~~In patient	897303033L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109172	03/26/1998	TX				U	10/21/1997	pt devel an inj site rxn p/vax;this is 1 of 4 pt from this facility to exp this rxn;									U	10/15/1997				OTH	OTH	unk	unk		~ ()~~~In patient	897303034L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109173	03/26/1998	TX				U	10/21/1997	pt devel an inj site rxn p/vax;this is 1 of 4 pt from this facility to exp this rxn;									U	10/15/1997				OTH	OTH	unk	unk		~ ()~~~In patient	897303035L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109174	03/26/1998	FL				U	10/14/1997	pt recv vax & devel n/v, diarrhea & cramping w/in 3 days of vax;this is 1 of 6 pt , out of 30 vaccinees, to exp rxn;									U	10/01/1997	10/01/1997	0		PVT	PVT	unk	unk		~ ()~~~In patient	897303036L	1						1	Diarrhoea; Hypertonia; Vomiting	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109175	03/26/1998	FL				U	10/14/1997	pt recv vax & devel n/v, diarrhea & cramping w/in 3 days of vax;this is 1 of 6 pt , out of 30 vaccinees, to exp rxn;									U	10/01/1997	10/01/1997	0		PVT	PVT	unk	unk		~ ()~~~In patient	897303037L	1						1	Diarrhoea; Pain; Vomiting	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109176	03/26/1998	FL				U	10/14/1997	pt recv vax & devel n/v, diarrhea & cramping w/in 3 days of vax;this is 1 of 6 pt, out of 30 vaccinees who exp this rxn p/vax;									U	10/01/1997	10/01/1997	0		PVT	PVT	unk	unk		~ ()~~~In patient	897303038L	1						1	Diarrhoea; Hypertonia; Vomiting	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109177	03/26/1998	FL				U	10/14/1997	pt recv vax & devel n/v, diarrhea & cramping w/in 3 days of vax;this is 1 of 6 pt, out of 30 vaccinees from this facility to exp this rxn;									U	10/01/1997	10/01/1997	0		PVT	PVT	unk	unk		~ ()~~~In patient	897303039L	1						1	Diarrhoea; Hypertonia; Vomiting	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109178	03/26/1998	FL				U	10/14/1997	pt recv vax & devel n/v, diarrhea & cramping w/in 3 days of vax;this is 1 of 6 pt, out of 30 vaccinees from this facility to exp this rxn;									U	10/01/1997	10/01/1997	0		PVT	PVT	unk	unk		~ ()~~~In patient	897303040L	1						1	Diarrhoea; Hypertonia; Vomiting	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109179	03/26/1998	FL				U	10/14/1997	pt recv vax & devel n/v, diarrhea & cramping w/in 3 days of vax;this if 1 of 6 pt, out of 30 vaccinees from this facility to exp this rxn;									U	10/01/1997	10/01/1997	0		PVT	PVT	unk	unk		~ ()~~~In patient	897303041L	1						1	Diarrhoea; Pain; Vomiting	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109180	03/26/1998	NJ	45.0			F	10/23/1997	2 days p/vax pt exp gen itching;no rash was present;pt also exp resp sx similar to seasonal allergy sx;				Y					U	10/17/1997	10/19/1997	2		PVT	PVT	Ibuprofen	NONE	recent unspecified surgery	~ ()~~~In patient	897310018L	1						1	Dyspnoea; Pruritus	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109181	03/26/1998	KY	33.0	33		F	10/23/1997	pt recv vax & immed devel an inj site rxn characterized by burning, redness & a 5inch welt;									U	10/21/1997	10/21/1997	0		OTH	PVT	unk	NONE		pt has had similar inj site rxn p/flu vax;~ ()~~~In patient	897310019L	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~~4~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109182	03/26/1998	UT	40.0			F	10/17/1997	pt recv vax & exp pain @ the inj site & felt jarring of the arm as was walking;then devel redness & a lump @ the inj site;self tx advil & hot compresses;next day exp dizziness;lump @ inj site resolved but was till red & sore;									U	10/16/1997	10/16/1997	0		OTH	OTH	unk	NONE		~ ()~~~In patient	897310020L	1						1	Dizziness; Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~PFIZER\WYETH~4978172~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109183	03/26/1998	AL				U	10/17/1997	pt recv vax & devel an inj site rxn characterized by redness, warmth, swelling & soreness;pt instructed to take DPH;									U	10/01/1997	10/01/1997	0		OTH	OTH	unk	unk		~ ()~~~In patient	897310021L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4978207~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109184	03/26/1998	WI				U	10/23/1997	w/in 24hr of vax several pt from this facility devel an inj site rxn characterized by redness, swelling & tenderness;									Y	10/21/1997	10/22/1997	1		PUB	MIL	unk	NONE		~ ()~~~In patient	897310022L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4978206~1~SC A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109185	03/26/1998	FL				U	10/24/1997	immed p/vax pt devel an inj site rxn characterized by an orange-sized area of redness & swelling;the rxn abated w/in 24hr;									Y	10/01/1997	10/01/1997	0		PVT	OTH	unk	unk	unspecified pulmonary disease	~ ()~~~In patient	897311002L	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109186	03/26/1998	MO	60.0	60		M	10/27/1997	2 days p/vax pt exp dizziness & lightheadedness when rolling over in bed;pt was unable to focus on clock, which appeared to be spinning;pt exp these sx on arising for the next 3 days;once out of bed, had no sx;									U	10/22/1997	10/24/1997	2		PVT	PUB	NONE	unk		~ ()~~~In patient	897311003L	1						1	Dizziness	FLU3~PFIZER\WYETH~~1~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109187	03/26/1998	NC	41.0	41		F	10/23/1997	of 200 people @ this facility who recv vax a few subsequently devel an inj site rxn;no further info was available @ the date of this report;reporter was not able to specify the number of people who exp this event;				Y					Y	10/22/1997	10/23/1997	1		PVT	PVT	unk	unk	allergic to pollen and cigarette smoke	~ ()~~~In patient	897311005L	1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~4978156~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109188	03/26/1998	NJ	38.0			F	10/23/1997	pt recv vax & immed p/vax there was a tremendous amount of bleeding @ the inj site;w/in 24hr a 15cm area of redness, warmth, induration, pain & mult purple & red ecchymotic splotches formed;pt was seen by MD who prescribed a steroid cream;				Y					U	10/20/1997	10/20/1997	0		PVT	PVT	unk	NONE		~ ()~~~In patient	897311009L	1						1	Ecchymosis; Haemorrhage; Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4978207~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109189	03/26/1998	FL				U	10/24/1997	several pt from this facility devel inj site rxn p/vax;the reporter was unable to specify the number of pt who exp this event;addtl reports will be generated when identifying info is provided;									U					PVT	OTH	unk	unk		~ ()~~~In patient	897311010L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~4978272~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109190	03/26/1998	DC	49.0	48		F	10/27/1997	w/in 3 days of vax pt devel an inj site rxn characterized by swelling, warmth & an area of redness measuring 3 to 4 inches in diameter;pt tx w/APAP;the redness persisted 3 days;									U	10/24/1997	10/27/1997	3		PUB	OTH	NONE	NONE		pt recv vax for past 8yr w/o adverse exp;~ ()~~~In patient	897311011L	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4978167~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109191	03/26/1998	NE	35.0			M	10/28/1997	2 days p/vax pt devel a pruritic, light red rash on abd;tx w/cortisone ointment;As of 28OCT (12 days p/onset), the rash was resolving;									U	10/14/1997	10/16/1997	2		PUB	OTH	NONE	NONE	this pt develops unspecified resp sx when exposed to chick feathers	~ ()~~~In patient	897311012L	1						1	Pruritus; Rash	FLU3~PFIZER\WYETH~~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109192	03/26/1998	WY	36.0	36		F	10/27/1997	pt recv vax & exp tingling in lt arm & hand;the tingling progressed to rt side, chest & lt side of face;pt also exp gen achiness & non-well feeling;									U	10/22/1997				PVT	OTH	Vitamins	NONE		~ ()~~~In patient	897311016L	1						1	Malaise; Myalgia; Paraesthesia	FLU3~PFIZER\WYETH~~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109193	03/26/1998	OH	62.0	62		F	10/31/1997	6hr p/vax pt devel an allergic rxn characterized by gen hives & swelling of the lower lip, eyes & rt hand;pt was seen by MD & tx w/DPH & medrol dosepak;				Y					Y	10/30/1997	10/30/1997	0		OTH	OTH	Lodine;Lipitor	NONE		~ ()~~~In patient	897311017L	1						1	Face oedema; Hypersensitivity; Oedema peripheral; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4978197~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109194	03/26/1998	TX				U	10/30/1997	pt devel rash 7 days p/vax;									U	10/21/1997	10/28/1997	7		PVT	PVT	unk	unk		~ ()~~~In patient	897311025L	1						1	Rash	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109195	03/26/1998	CA				U	10/29/1997	pt recv vax & devel gen aching & inj site rxn characterized by redness, swelling & a knot;the reporter was not able to specify the number of pt who exp this event;addtl reports will be generated when identifying info is provided;									U					PVT	OTH	ink	unk		~ ()~~~In patient	897311026L	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Myalgia	FLU3~PFIZER\WYETH~4978202~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109196	03/26/1998	TX	62.0	62		M	10/28/1997	approx 1wk p/vax pt devel shingles;the lesions started on lt scapula & shoulder area;they were resolving as of 4NOV97;									U	10/08/1997				PUB	OTH	Zestril	NONE		~ ()~~~In patient	897311027L	1						1	Herpes zoster	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109197	03/26/1998	NY	45.0	45		M	10/29/1997	w/in 1.5hr of vax pt devel an allergic rxn characterized by pain & itching @ the inj site;rash on lt chest, shoulder blade & axilla;and hives, itching & pain of the lt chest;seen by dermatologist 3 days post vax & tx w/DPH, cortisone shot				Y					Y	10/24/1997	10/24/1997	0		PUB	OTH	NONE	NONE	PCN allergy	pt has recv previous flu vax w/o adverse exp;~ ()~~~In patient	897311029L	1						1	Hypersensitivity; Injection site pain; Myositis; Neuralgia; Pruritus; Rash; Urticaria	FLU3~PFIZER\WYETH~4978184~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109198	03/26/1998	NJ				U	10/28/1997	pt recv vax & devel an inj site rxn;no further info was available @ the date of this report;reporter indicates that about a dozen pt exp this event;however, they are not presently identifiable;addtl reports will be generated;									U	10/01/1997	10/01/1997	0		OTH	OTH	unk	unk		~ ()~~~In patient	897311030L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109199	03/26/1998	NY	2.0	2	.6	F	10/28/1997	w/in 24hr of vax pt devel gen urticaria;pt was seen by MD & tx w/DPH;the hives recurred periodically over a day period;28OCT the hives had resolved;addtl info recv 1DEC98 indicated that pt remained recovered;				Y					Y	10/14/1997	10/15/1997	1		PVT	PVT	NONE	NONE	asthma	~ ()~~~In patient	897314008L	1						1	Urticaria	FLU3~PFIZER\WYETH~4978144~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109200	03/26/1998	MN				U	10/17/1997	w/in 10min of vax pt devel an inj site rxn characterized by a palm sized area of redness, swelling & warmth;pt was seen in ER where nurse mad a dx of an allerg rxn;17OCT97 rxn was resolving;this is 1 of 2 reports from this facility;				Y					U	10/01/1997	10/01/1997	0		OTH	OTH	unk	unk		~ ()~~~In patient	897314012L	1						1	Hypersensitivity; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109201	03/26/1998	MN				U	10/17/1997	w/in 10min of vax pt devel gen rash & an inj site rxn characterized by redness, swelling & warmth;pt was seen in ER & nurse dx allerg rxn;this is 1 of 2 reports from this facility;				Y					U	10/01/1997	10/01/1997	0		OTH	OTH	unk	unk		~ ()~~~In patient	897314014L	1						1	Hypersensitivity; Injection site hypersensitivity; Injection site oedema; Rash; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109202	03/26/1998	TX				U	10/20/1997	pt recv vax & devel an inj site rxn;this is 1 of 4 pt from this site to have an adverse exp p/vax;									U	10/01/1997	10/01/1997	0		PVT	PVT	unk	unk		~ ()~~~In patient	897314015L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~4978196~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109203	03/26/1998	TX				U	10/20/1997	pt recv vax & devel an inj site rxn;this is 1 of 4 pt from this site to have an adverse exp p/vax;									U	10/01/1997	10/01/1997	0		PVT	PVT	unk	unk		~ ()~~~In patient	897314017L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~4978196~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109204	03/26/1998	TX				U	10/20/1997	pt recv vax & devel cellulitis @ the inj site;this is 1 of 4 pt from this site to have an adverse exp p/vax;									U	10/01/1997	10/01/1997	0		PVT	PVT	unk	unk		~ ()~~~In patient	897314019L	1						1	Cellulitis; Injection site hypersensitivity	FLU3~PFIZER\WYETH~4978196~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109205	03/26/1998	TX				U	10/20/1997	pt recv vax & devel cellulitis @ the inj site;this is 1 of 4 pt from this site to have an adverse exp p/vax;									U	10/01/1997	10/01/1997	0		PVT	PVT	unk	unk		~ ()~~~In patient	897314020L	1						1	Cellulitis; Injection site hypersensitivity	FLU3~PFIZER\WYETH~4978196~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109206	03/26/1998	ID	27.0	27		F	10/21/1997	w/in 24hr of vax pt devel an inj site rxn characterized by swelling, redness, induration & warmth;pt exp muscle aches from shoulder to elbow & had stiff bending elbow & rotating shoulder;pt recovered p/5 days;this is 1 of 5 pt w/this rxn;									Y	10/01/1997	10/01/1997	0		PUB	OTH	Prenatal vitamins	NONE		~ ()~~~In patient	897314021L	1						1	Arthropathy; Hypokinesia; Injection site hypersensitivity; Injection site mass; Injection site oedema; Myalgia; Vasodilatation	FLU3~PFIZER\WYETH~4978159~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109207	03/26/1998	ID	39.0			F	10/21/1997	w/in 24hr  of vax pt devel an inj site rxn characterized by an area of redness & heat the size of a cup;then devel myalgia & arthralgias & then a fever;pt was seen by MD who dx a resp infect & prescribed med;pt recovered;				Y					Y					PUB	OTH	unk	unk	fall environmental allergies	~ ()~~~In patient	897314022L	1						1	Arthralgia; Injection site hypersensitivity; Myalgia; Pharyngitis; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4978159~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109208	03/26/1998	ID	32.0			F	10/21/1997	w/in 24hr of vax pt devel fever, myalgia, arthralgias & an inj site rxn characterized by a 3.5inch area of redness, warmth & swelling;pt recovered p/4 days;this is 1 of 5 pt from this facility to have an adverse exp p/vax;									Y					PUB	PUB	NONE	NONE	pine allergy	~ ()~~~In patient	897314023L	1						1	Arthralgia; Injection site hypersensitivity; Injection site oedema; Myalgia; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4978159~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109209	03/26/1998	ID	41.0			F	10/21/1997	w/in 24hr of vax pt devel an inj site rxn characterized by a softball sized area of redness, swelling & warmth;pt recovered;this is 1 of 5 pt from this facility to have an adverse exp p/vax;									Y					PUB	OTH	Prenatal vitamins	NONE		~ ()~~~In patient	897314024L	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4978159~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109210	03/26/1998	ID	52.0			F	10/21/1997	w/in 24hr of vax pt devel an inj site rxn characterized by a 3cm by 3cm area of redness, inflammation & tenderness;pt recovered;this is 1 of 5 pt from this facility to have an adverse exp p/vax;									Y					PUB	OTH	NONE	NONE		~ ()~~~In patient	897314025L	1						1	Injection site hypersensitivity; Injection site inflammation; Injection site pain	FLU3~PFIZER\WYETH~4978159~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109211	03/26/1998	LA	47.0	47		F	10/23/1997	pt recv vax & exp itching of hands, arms, chest & neck;went to ER the next day & cortisone given;went home felt dyspnea & felt throat closing up & returned to ER;pt given ventolin inhalation tx, to which pt is allergic;				Y	Y				U	10/20/1997	10/22/1997	2		PUB	OTH	Estrace;Paxil;Margesic H;Valium;	NONE	allergic to morphine sulfate, DPH & ventolin;depression	~ ()~~~In patient	897303030L	1						1	Dyspnoea; Hypersensitivity; Laryngospasm; Pruritus	FLU3~PFIZER\WYETH~4978140~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0109222	03/26/1998	OH				U	10/29/1997	w/in 12hr of vax pt devel an inj site rxn characterized by tenderness & a 2inch by 2inch welt;pt was improving as of 29OCT;this is 1 of 5 pt out of 12 vaccinees to exp this event;									U	10/01/1997	10/01/1997	0		PUB	OTH	unk	unk		~ ()~~~In patient	897314030L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109223	03/26/1998	OH				U	10/29/1997	w/in 12hr of vax pt devel an inj site rxn characterized by tenderness & a 2inch by 2 inch welt;pt was improving as of 29OCt;this is 1 of 5 pt, out of 12 vaccinees, to exp this event;									U	10/01/1997	10/01/1997	0		PUB	OTH	unk	unk		~ ()~~~In patient	897314031L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109224	03/26/1998	OH				U	10/29/1997	w/in 12hr of vax pt devel an inj site rxn characterized by tenderness & a 2inch by 2inch welt;pt improving as of 29OCT;this is 1 of 5 pt, out of 12 vaccines, to exp this event;									U	10/01/1997	10/01/1997	0		PUB	OTH	unk	unk		~ ()~~~In patient	897314032L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109225	03/26/1998	OH				U	10/29/1997	w/in 12hr of vax pt devel an inj site rxn characterized by tenderness & a 2-inch by 2-inch welt;pt was improving as of 29OCT;this is 1 of 5 patients, out of 12 patients to exp this event;									U	10/01/1997	10/01/1997	0		PUB	OTH	unk	unk		~ ()~~~In patient	897314033L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109226	03/26/1998	OH				U	10/29/1997	w/in 12hr of vax pt devel an inj site rxn characterized by tenderness & a 2inch by 2 inch welt;pt improving as of 29OCT;this is 1 of 5 pt, out of 12 vaccinees, to exp this event;									U	10/01/1997	10/01/1997	0		PUB	OTH	unk	unk		~ ()~~~In patient	897314034L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109227	03/26/1998	TN	40.0			M	10/22/1997	pt devel an inj site rxn characterized by swelling, pain, erythema p/vax;									U	10/18/1997	10/18/1997	0		OTH	PVT	NONE	NONE		~ ()~~~In patient	897314035L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109228	03/26/1998	VT				U	10/22/1997	several pt devel exaggerated inj site rxn p/vax;reporter unable to specify the number of people who exp this event;				Y					U					PVT	PVT	unk	NONE		~ ()~~~In patient	897314036L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109229	03/26/1998	PA	48.0	48		F	10/22/1997	w/in 24hr of vax pt devel lymphadenopathy, described a painful swelling in the lt axilla which radiated down the medial portion of the lt arm;				Y					Y	10/13/1997	10/14/1997	1		PVT	PVT	NONE	NONE		~ ()~~~In patient	897314037L	1						1	Lymphadenopathy; Neuritis; Pain	FLU3~PFIZER\WYETH~4978269~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109230	03/26/1998	NC				U	10/22/1997	pt recv vax & devel an inj site rxn characterized by a 2.5in area of swelling, induration & erythema;pt treated w/warm soaks & APAP;This is 1 of 6 reports from this facility of inj site rxn p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	897314038L	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109231	03/26/1998	GA	54.0	54		F	10/21/1997	pt w/hx of elevated liver function tests, devel elevation of  unspecified liver enzymes p/vax;									Y	09/26/1997	10/17/1997	21		PVT	PUB	Cozaar 50 mg qd, Precose 25 mg w/meals	NONE	elevated liver function tests	~ ()~~~In patient	897314040L	1						1	Alanine aminotransferase increased; Aspartate aminotransferase increased; Hepatic function abnormal	FLU3~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~SMITHKLINE BEECHAM~2220B6~2~IM A~~HEP B (ENGERIX-B)~1	USA		Influenza
0109232	03/26/1998	VA	54.0	54		M	10/21/1997	3 days p/vax pt devel a scratchy throat, watery eyes & sinus & nasal congestion;				Y					U	10/14/1997	10/17/1997	3		OTH	OTH	unk	NONE		~ ()~~~In patient	897314041L	1						1	Eye disorder; Pharyngitis; Rhinitis; Sinusitis	FLU3~PFIZER\WYETH~4978205~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109233	03/26/1998	IL	51.0			F	11/03/1997	pt recv vax & devel an inj site rxn characterized by redness & a hard knot;									U	10/30/1997	10/30/1997	0		OTH	OTH	NONE	NONE		~ ()~~~In patient	897314042L	1						1	Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0109234	03/26/1998	NC				U	10/31/1997	pt devel a gen rash described as small red spots under the skin, 14 days p/vax;reporter indicated 6-8pt exp this event;however, they are not presently identifiable;									U					OTH	OTH	unk	unk		~ ()~~~In patient	897314043L	1						1	Rash	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109235	03/26/1998	CO				U	10/23/1997	pt recv vax & exp pain @ inj site;									U					OTH	OTH	unk	unk		~ ()~~~In patient	897314045L	1						1	Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109236	03/26/1998	MI	61.0	61		F	10/17/1997	1 day p/vax pt devel an inj site rxn characterized by pain,inflammation & edema;pt treated w/ibuprofen & applications of ice;this is 1 of 2 pt of this facility, out of 53 vaccinees, to have an adverse exp p/vax;									Y	10/15/1997	10/16/1997	1		OTH	OTH	unk	NONE		~ ()~~~In patient	897314046L	1						1	Injection site inflammation; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~~4~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109237	03/26/1998	MI				F	10/17/1997	1 day p/vax pt exp itching @ inj site;itching resolved spontaneously p/15hr;this is 1 of 2 pt of this facility, out of 53, patients, to have an adverse exp p/vax;									Y	10/15/1997	10/16/1997	1		OTH	OTH	unk	NONE		~ ()~~~In patient	897314047L	1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~~4~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109238	03/26/1998	VA	44.0	44		F	10/23/1997	pt recv vax & devel an inj site rxn characterized by redness & soreness;this is 1 of 3 pt from this facility to devel an inj site rxn p/vax lot# 4978198				Y					Y	10/21/1997	10/21/1997	0		PUB	OTH	unk	unk		~ ()~~~In patient	897314048L	1						1	Hypersensitivity; Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4978198~1~SC A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109239	03/26/1998	VA	27.0	27		F	10/23/1997	pt recv vax & devel an inj site rxn characterized by redness & soreness;this is 1 of 3 pt from this facility to devel an inj site rxn p/vax lot# 4978198;									Y	10/21/1997	10/21/1997	0		PUB	OTH	unk	NONE		~ ()~~~In patient	897314049L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4978198~1~SC A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109240	03/26/1998	VA	38.0	38		F	10/23/1997	pt recv vax inadvertently subcutaneously ;pt devel an allerg rxn characterized by difficulty breathing & redness & swelling @ the inj site;pt was taken to the ER & tx w/unspecified med; 2 days post vax skin @ inj site was peeling from arm;				Y					Y	10/21/1997	10/21/1997	0		PUB	OTH	unk	NONE	egg allergy	~ ()~~~In patient	897314050L	1						1	Dermatitis exfoliative; Dizziness; Dyspnoea; Hypersensitivity; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4978198~1~SC~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109241	03/26/1998	NJ	53.0	53		F	10/22/1997	1 day p/vax pt devel an inj site rxn characterized by soreness & sl redness;the soreness was worse 2 days post vax;this is 1 of 2 reports from this facility of inj site rxn p/vax lot# 4978199									U	10/20/1997	10/21/1997	1		PVT	PVT	Tamoxifen;Covera;	NONE	HTN, breast cancer	~ ()~~~In patient	897314051L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4978199~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109243	03/26/1998	GA				U	10/16/1997	pt recv vax & devel inj site rxn characterized by an area of redness, warmth & pain measuring 2-3 inches in diameter, p/vax lot# 4978188;this is 1 of 3  who exp this rxn;									U	10/13/1997				PVT	OTH	unk	unk		~ ()~~~In patient	897314053L	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4978188~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109245	03/26/1998	NJ				U	10/22/1997	3 days p/vax pt devel a rash on chest & back;this is 1 of 3 pt from this facility to devel a rash p/vax;									U	10/17/1997	10/20/1997	3		OTH	OTH	unk	unk		~ ()~~~In patient	897324006L	1						1	Rash	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109246	03/26/1998	NJ				U	10/22/1997	3 days p/vax pt devel a rash on chest & back;this is 1 of 3 pt from this facility to devel a rash p/vax;									U	10/17/1997	10/20/1997	3		OTH	OTH	unk	unk		~ ()~~~In patient	897324007L	1						1	Rash	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109247	03/26/1998	NJ				U	10/22/1997	3 days p/vax pt devel a rash on chest & back;this is 1 of 3 pt from this facility to devel a rash p/vax;									U	10/17/1997	10/20/1997	3		OTH	OTH	unk	unk		~ ()~~~In patient	897324008L	1						1	Rash	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109248	03/26/1998	NC				U	10/22/1997	pt recv vax & devel an inj site rxn characterized by a 2.5inch area of swelling, induration & erythema;this is 1 of 6 reports from this facility of inj site rxn p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	897324010L	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109249	03/26/1998	NC				U	10/22/1997	pt recv vax & devel an inj site rxn characterized by a 2.5 inch area of swelling, induration & erythema;this is 1 of 6 reports from this facility of inj site rxn p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	897324011L	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109250	03/26/1998	NC				U	10/22/1997	pt recv vax & devel an inj site rxn characterized by a 2.5inch area of swelling, induration & erythema;this is 1 of 6 reports from this facility of inj site rxn p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	897324912L	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109251	03/26/1998	NC				U	10/22/1997	pt recv vax & devel an inj site rxn characterized by a 2.5inch area of swelling, induration & erythema;this is 1 of 6 reports from this facility of inj site rxn p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	897324013L	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109252	03/26/1998	NC				U	10/22/1997	pt recv vax & devel inj site rxn characterized by a 2.5inch area of swelling, induration & erythema;this is 1 of 6 reports from this facility of inj site rxn p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	897324014L	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109253	03/26/1998	MN				U	10/13/1997	pt recv vax & devel an inj site rxn characterized by redness, swelling & soreness w/in 24hr of receiving inj lot# 4978165;this is 1 of 4 pt from this facility to exp this rxn;									U	10/01/1997	10/01/1997	0		PUB	OTH	unk	NONE		~ ()~~~In patient	897324015L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4978165~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109254	03/26/1998	MN				U	10/13/1997	pt recv vax & devel inj site rxn characterized by redness, swelling & soreness w/in 24hr of vax lot# 4978165;this is 1 of 4 pt from this facility to devel rxn;									U	10/01/1997	10/01/1997	0		PUB	OTH	unk	NONE		~ ()~~~In patient	897324016L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4978165~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109255	03/26/1998	MN				U	10/24/1997	pt recv vax & devel fever of 104, swelling of the arm into which pnu immune 23 was injected, h/a, vomiting, puffy eyes & blurred vision;									U					OTH	OTH	unk	unk		~ ()~~~In patient	897329018L	1						1	Amblyopia; Face oedema; Headache; Oedema peripheral; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~442522~UNK~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0109256	03/26/1998	VA	59.0	59		F	10/28/1997	48hr p/vax pt devel an allergic rxn characterized by gen rash, swelling of the hands & diff breathing;pt was taken to ER for tx;				Y					Y	10/24/1997	10/26/1997	2		PUB	PUB	unk	NONE		~ ()~~~In patient	897329020L	1						1	Dyspnoea; Hypersensitivity; Oedema peripheral; Pruritus; Rash; Urticaria	FLU3~PFIZER\WYETH~4978202~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109257	03/26/1998	NC	46.0	46		U	10/27/1997	45min p/vax pt exp n/v, h/a & dry mouth;pt was taken to ER;				Y					U	10/27/1997	10/27/1997	0		PUB	OTH	unk	NONE		~ ()~~~In patient	897329021L	1						1	Dry mouth; Headache; Vomiting	FLU3~PFIZER\WYETH~4978142~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109258	03/26/1998	CA				U	11/03/1997	pt recv vax & devel extreme eosinophilia;this is 1 of 2 pt from this site to have an adverse exp p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	897329022L	1						1	Eosinophilia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109259	03/26/1998	CA				U	11/03/1997	pt recv vax & devel foot drop;this is 1 of 2 pt from t his site to have an adverse exp p/vax;				Y					U					OTH	OTH	unk	unk		~ ()~~~In patient	897329024L	1						1	Peroneal nerve palsy	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109261	03/26/1998	IA				U	11/05/1997	pt recv vax & devel an inj site rxn characterized by redness, soreness & induration;reporter indicated that 60 out of 90 staff residents vaccinated exp this event;however they are not presently identifiable;									U	11/01/1997				OTH	OTH	unk	unk		~ ()~~~In patient	897329029L	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~PFIZER\WYETH~4978191~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109263	03/26/1998	MI	60.0	60		F	11/04/1997	3 days p/vax pt devel bell's palsy;				Y					Y	10/27/1997	10/29/1997	2		PVT	PVT	unk	NONE		~ ()~~~In patient	897329031L	1						1	Facial palsy	FLU3~PFIZER\WYETH~4978173~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109264	03/26/1998					F	11/04/1997	pt recv vax & devel a prolonged illness described as muscle soreness, gen weakness, loss of balance, nausea & severe joint pain;									U					OTH	OTH	unk	unk		~ ()~~~In patient	897329032L	1						1	Arthralgia; Asthenia; Coordination abnormal; Myalgia; Nausea	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109265	03/26/1998	NJ	40.0	40		F	10/21/1997	approx 4hr p/vax pt reported that devel an inj site rxn characterized by swelling & soreness;the swelling extended from axilla to elbow & impaired mobility;w/in 24hr swelling extended below the elbow & the entire area red & hot;sl feb;									U	10/16/1997	10/16/1997	0		PUB	OTH	unspecified oral contraceptive	NONE		~ ()~~~In patient	897329033L	1						1	Hypokinesia; Oedema; Oedema peripheral; Pain; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4978208~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0109266	03/26/1998	KS				U	11/03/1997	pt recv vax & devel lymphadenopathy described as golf ball sized lumps in the axilla of the arm into which the vaccine was injected;this is 1 of 5 pt from this facility to exp this event p/vax;									U					PVT	PVT	unk	unk		~ ()~~~In patient	897330003L	1						1	Lymphadenopathy	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109267	03/26/1998	KS				U	11/03/1997	pt recv vax & devel lymphadenopathy described as golf ball sized lumps in the axilla of the arm into which vax was injected;this is 1 of 5 employees from this facility to exp this event p/vax;									U					PVT	PVT	unk	unk		~ ()~~~In patient	897330004L	1						1	Lymphadenopathy	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109268	03/26/1998	KS				U	11/03/1997	pt recv vax & devel lymphadenopathy described as golf ball sized lumps in the axilla of the arm into which vax was injected;this is 1 of 5 pt from this facility to exp this event p/vax;									U					PVT	PVT	unk	unk		~ ()~~~In patient	897330005L	1						1	Lymphadenopathy	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109269	03/26/1998	KS				U	11/03/1997	pt recv vax & devel lymphadenopathy described as golf ball sized lumps in the axilla of the arm into which vax was injected;this is 1 of 5 pt from this facility to exp this event p/vax;									U					PVT	PVT	unk	unk		~ ()~~~In patient	897330006L	1						1	Lymphadenopathy	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109270	03/26/1998	KS				U	11/03/1997	pt recv vax & devel lymphadenopathy described as golf ball size lumps in the axilla of the arm into which vax injected;this is 1 of 5 pt from this facility to exp this event p/vax;									U					PVT	PVT	unk	unk		~ ()~~~In patient	897330007L	1						1	Lymphadenopathy	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109271	03/26/1998	WI	37.0	37		M	11/18/1997	pt recv vax 16OCT97 & exp pain @ inj site;13NOV pt cont to exp pain w/certain motion;pt has not been seen by healthcare provider & has not tried any tx for pain;this is 1 of 2 pt from this facility to exp pain @ the inj site p/vax									U	10/16/1997				PUB	OTH	NONE	NONE		~ ()~~~In patient	897336006L	1						1	Hypokinesia; Injection site pain	FLU3~PFIZER\WYETH~4978168~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109272	03/26/1998	WI	50.0	50		M	11/18/1997	Pt exp inject site pain 3 days following vax. Pt not seen by MD. He self-treated w/aspirin and warm/cold compress/no relief. Pt cont to exp pain w/certain movements.									U	10/16/1997	10/18/1997	2		PVT	OTH	None	None		~ ()~~~In patient	897336007L	1						1	Hypokinesia; Injection site pain; Myalgia	FLU3~PFIZER\WYETH~4978168~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109273	03/26/1998	CA	42.0	42		F	11/18/1997	Within 24 hr of vax, pt devel severe pain behind right ear. Then devel right facial paralysis (Bell's palsy). Then pt devel herpes zoster with vesicles in the ear & throat. Dx as herpes zoster in the 7th nerve-Ramsey Hunt.				Y					Y	10/09/1997	10/11/1997	2		OTH	OTH	Unknown	None		~ ()~~~In patient	897336008L	1						1	Dermatitis bullous; Facial palsy; Herpes zoster; Infection; Pain	FLU3~PFIZER\WYETH~4978196~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109274	03/26/1998	OH	90.0			F	11/17/1997	Within 12 hr of vax, several pt at this facility devel inject site, with redness, tenderness & induration.									Y	11/03/1997	11/04/1997	1		OTH	PUB	Unk	None		~ ()~~~In patient	897336010L	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~PFIZER\WYETH~4978296~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109276	03/26/1998	SC	68.0	68		F	11/21/1997	pt recv vax & exp an unspecified adverse exp;				Y					U	10/15/1997	10/18/1997	3		MIL	MIL	unk	unk		~ ()~~~In patient	897337004L	1						1	Arthralgia; Hypertonia; Myalgia; Red blood cell sedimentation rate increased	FLU3~PFIZER\WYETH~4978331~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109277	03/26/1998	UT	42.0			F	11/11/1997	12 to 24hr p/vax pt devel fever, myalgia & arthralgia;this report was recv 3wk post vax;the fever, myalgia & arthralgia persisted @ that time;pt was sl ill @ the time of vax;				Y					U	10/01/1997	10/01/1997	0		PVT	OTH	NONE	sl ill		~ ()~~~In patient	897337005L	1						1	Arthralgia; Injection site oedema; Injection site pain; Myalgia; Pain; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109279	03/26/1998	MI	49.0	48		F	11/19/1997	1 day p/vax pt began exp h/a which started @ back of neck & radiated to the top of head;exp h/a 2wk;2wk post vax pt devel a low grade fever & n;blood tests revealed elevation of liver enzyme levels;serology for hepatitis was neg;lost 12#				Y					Y	10/01/1997	10/13/1997	12		PVT	OTH	Atenolol, Estraderm	NONE	hypertension, seasonal allergies	~ ()~~~In patient	897344001L	1						1	Anorexia; Asthenia; Headache; Hepatic function abnormal; Nausea; Pyrexia; Weight decreased; Headache; Hepatic function abnormal; Hyperhidrosis; Nausea; Pyrexia; Weight decreased	FLU3~PFIZER\WYETH~4978197~7+~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~~1~A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0109280	03/26/1998	MN				F	11/10/1997	pt recv vax &  4 days p/vax, a FANA (inflammatory) screen was performed;the resulting levels were extremely elevated;									U	10/27/1997				OTH	OTH	unk	NONE		~ ()~~~In patient	897344008L	1						1	Hepatic function abnormal	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109281	03/26/1998	NC				F	11/12/1997	1 day p/vax pt exp gen itching;eyeballs & ears also itched;pt stated that felt as though bugs were inside her;									U	10/26/1997	10/27/1997	1		OTH	OTH	unk	unk		~ ()~~~In patient	897344010L	1						1	Pruritus	FLU3~PFIZER\WYETH~4978213~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109282	03/26/1998	SC	44.0	44		M	11/11/1997	8 to 9 days post vax pt devel serum sickness characterized by fever up to 101, migratory polyarthritis & tendonitis;joints primarily affected were both shoulders, both elbows, both knees, second lt metacarpal joint & epicondyles;									Y	10/20/1997	10/28/1997	8	ESR mildly elevated;Eosinophil count:nl;tests for parvovirus, rheumatoid arthritis, connective tissue disorder: negative;	PVT	PVT	NONE	NONE	allergic to Clinoril	~ ()~~~In patient	897344011L	1						1	Arthritis; Pyrexia; Serum sickness; Tendon disorder	FLU3~PFIZER\WYETH~4978205~7+~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109283	03/26/1998	SC	52.0	52		M	11/25/1997	25min p/vax pt exp facial paralysis & numbness & tingling in the arm;									Y	11/25/1997	11/25/1997	0		OTH	OTH	unk	none	hypertension; hyperthyroidism; hyperlipidemia	~ ()~~~In patient	897344014L	1						1	Facial palsy; Paraesthesia	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109284	03/26/1998	NC				F	11/21/1997	1 day p/vax pt awoke w/angioedema & chest pain; tx w/claritin before being seen in hlth clinic;@ clinic pt treated w/epi, albuterol & pred;pt appeared to be recovering @ the date of this report;				Y					U	11/20/1997	11/21/1997	1		OTH	OTH	unk	NONE	unspecified allergies;no egg allergy	~ ()~~~In patient	897344016L	1						1	Angioneurotic oedema; Chest pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109285	03/26/1998	WI	71.0	71		F	11/26/1997	w/in 1wk of vax pt reported wife exp dizziness, lightheadedness, weakness & changing refractory vision problems which persisted as of 26NOV;MRI of head & testing for hypoglycemia were neg;BP nl;pt had fallen prior to onset of sx;									U	10/01/1997	10/01/1997	0	testing for hypoglycemia: negative;MRI of head:nl	PVT	PVT	unk	NONE		pt recv vax for many years w/o adverse exp;~ ()~~~In patient	897344021L	1						1	Asthenia; Dizziness; Visual disturbance	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109286	03/26/1998	MN				M	11/19/1997	1 day p/vax pt exp tingling in arm, neck & side of head;the tingling sensation inc @ the side of head & hair became sensitive to touch;20NOV had recovered;									Y	11/05/1997	11/06/1997	1		PUB	PUB	unk	NONE		~ ()~~~In patient	897344017L	1						1	Paraesthesia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109287	03/26/1998	OR	77.0	76		F	11/25/1997	pt recv vax 28OCT97 & exp malaise, sore throat & pain @ the inj site;sx persisted 1mo post vax;				Y					Y	10/28/1997	10/28/1997	0		PUB	OTH	calcium carbonate	NONE		~ ()~~~In patient	897344024L	1						1	Dysphonia; Injection site pain; Malaise; Pharyngitis	FLU3~PFIZER\WYETH~4978156~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109288	03/26/1998	MD	32.0	32		M	11/25/1997	1 day p/vax pt devel lt sided facial numbness; 3 days post vax seen in ER where serology for HIV & lyme disease was performed (results unk to reporter);ER MD dx bell's palsy;				Y					Y	10/30/1997	11/17/1997	18	serology for HIV & lyme disease: results not known;	OTH	OTH	none	unk		~ ()~~~In patient	897344025L	1						1	Facial palsy; Paraesthesia; Salivary hypersecretion	FLU3~PFIZER\WYETH~4978191~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109289	03/26/1998	OH				U	11/26/1997	pt w/a hx of thimerosal sensitivity had an unspecified adverse exp p/vax;									U					OTH	OTH	unk	unk	thimerosal sensitivity	pt had no adverse exp p/vax;~ ()~~~In patient	897344026L	1						1	Unevaluable event	FLU3~PFIZER\WYETH~~3~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109290	03/26/1998	KY	42.0	41		F		w/in 24hr p/vax pt devel an inj site rxn characterized by an egg-sized area of redness, induration & burning;pt recovered p/2 days w/o tx;									Y	11/06/1997	11/07/1997	1		PUB	PVT	Axid;Atarax;xanax;allery inj	NONE	yeast allergy	~ ()~~~In patient	897344028L	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~PFIZER\WYETH~4978173~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109291	03/26/1998	CA	48.0	48		F	11/06/1997	2 days p/vax pt devel inj site pain w/inability to move shoulder;pt  seen by MD & treated w/pred;10NOV there was no improvement in sx;reporter stated that the pt was injected just under acromian process, & inj may have been intra-articular				Y					U	10/25/1997	10/27/1997	2		OTH	OTH	NONE	NONE		~ ()~~~In patient	897344030L	1						1	Arthropathy; Hypokinesia; Injection site pain	FLU3~PFIZER\WYETH~4978215~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109292	03/26/1998	VT				U	11/06/1997	pt recv vax & devel an inj site rxn characterized by pain & redness;									U					OTH	OTH	unk	unk		~ ()~~~In patient	897344032L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109293	03/26/1998	WI	55.0	55		F	11/06/1997	approx 3wk p/vax pt devel pain in lt shoulder joint & pain w/arm movement;									U	10/16/1997	11/04/1997	19		PUB	PUB	unk	NONE		~ ()~~~In patient	897344033L	1						1	Hypokinesia; Pain	FLU3~PFIZER\WYETH~4978168~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109295	03/26/1998	MS	62.0	62		F	11/10/1997	pt recv vax & w/in 18hr devel a blotchy rash on chest & neck;pt stated that rash resembled a sunburn;pt self treated w/oral DPH & DPH cream;3 days post vax a small area of rash persisted on neck;									U	11/06/1997	11/07/1997	1		PVT	PVT	Dyazide;Zestril;Synthroid;BABy ASA;	NONE		~ ()~~~In patient	897344035L	1						1	Rash maculo-papular	FLU3~PFIZER\WYETH~4978170~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109296	03/26/1998	FL				M	12/05/1997	pt recv perceived that smell like wet chicken feathers p/recv vax;according to reporter no one else was aware of any odor emanating from pt;19JAN98 pt no longer perceives an odor;									Y	11/20/1997	12/05/1997	15		PVT	PVT	Insulin;Accupril;Glucophage;Nitrostat;Naprosyn;Cytotec	unk	diabetes mellitus, ischemic heart disease;	~ ()~~~In patient	897344036L	1						1	Unevaluable event	FLU3~PFIZER\WYETH~4978200~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109297	03/26/1998	DE				U	12/05/1997	pt recv vax & devel petechiae 24hr p/vax;									U	11/24/1997	11/25/1997	1		PVT	OTH	coumadin	unk		~ ()~~~In patient	897344037L	1						1	Petechiae	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109299	03/26/1998	OH				U	11/11/1997	approx 2k p/vax several nursing home pt devel a gen rash;reporter was not able to specify the number of pt who exp this event;addtl reports will be generated when identifying info is provided;									U	10/01/1997	11/01/1997	31		OTH	OTH	unk	unk		~ ()~~~In patient	897344041L	1						1	Rash	FLU3~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109300	03/26/1998	NH	52.0	52		F	12/05/1997	pt inadvertently splashed flu vax in eye & exp a burning sensation;pt eye was flushed w/cool water & sx subsided;									Y	12/05/1997	12/05/1997	0		PUB	OTH	NONE	NONE		~ ()~~~In patient	897344042L	1						1	Pain	FLU3~PFIZER\WYETH~4978144~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109301	03/26/1998	NY	69.0	69		F	11/07/1997	pt recv vax & devel sixth-nerve palsy;this is 1 of 2 pt who exp this event;				Y					U	10/06/1997	10/07/1997	1		OTH	OTH	unk	unk	status-post cataract surgery (date unspecified);	~ ()~~~In patient	897344043L	1						1	Diplopia; Neuropathy; Paralysis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109302	03/26/1998	NY				U	11/07/1997	pt recv vax & devel sixth-nerve palsy;this is 1 of 2 pt who exp this event;									U					OTH	OTH	unk	unk		~ ()~~~In patient	897344044L	1						1	Neuropathy; Paralysis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109303	03/26/1998	NY				U	12/01/1997	pt recv vax & devel lumps @ the inj site 2 to 3 wk p/vax;the lumps needed to be drained several times;the resulting fluid was clear in color;this is 1 of 2 pt who exp this event;				Y					U					OTH	OTH	unk	unk		~ ()~~~In patient	897344045L	1						1	Injection site mass	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109304	03/26/1998	NY				U	12/01/1997	pt recv vax & devel lumps @ the inj site 2 to 3 wk p/vax;the lumps needed to be drained several times;the resulting fluid was clear in color;				Y					U					OTH	OTH	unk	unk		~ ()~~~In patient	897344046L	1						1	Injection site mass	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109305	03/26/1998	WI	33.0	33		F	12/05/1997	w/in 24hr of vax pt devel a pin-point, itchy rash over upper body;also devel an inj site rxn characterized by redness & swelling;pt treated self w/DPH;sx resolved w/in 1wk;this is 1 of 2 pt from this facility to devel a rash p/vax;									Y	10/06/1997	10/07/1997	1		PVT	OTH	unk	NONE		~ ()~~~In patient	897344047L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus; Rash	FLU3~PFIZER\WYETH~4978206~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109306	03/26/1998	WI				F	12/05/1997	w/in 24hr of vax pt devel a pin-point, itchy rash on the trunk of body, legs & arms;treated self w/DPH & sx resolved w/in 1wk;this is 1 of 2 pt from this facility to devel a rash p/vax lot#4978206									Y	10/08/1997	10/09/1997	1		PVT	OTH	unk	NONE		~ ()~~~In patient	897344048L	1						1	Oedema peripheral; Pruritus; Rash	FLU3~PFIZER\WYETH~4978206~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109307	03/26/1998	AZ				U	11/06/1997	pt recv vax & devel inj site rxn characterized by redness, swelling & warmth;THis is 1 of 7 employees of this facility to have an adverse exp p/vax lot# 4978167;									U	10/01/1997	10/01/1997	0		PVT	PVT	unk	NONE		~ ()~~~In patient	897349005L	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4978167~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109308	03/26/1998	AZ				U	11/06/1997	pt devel an inj site rxn characterized by redness, swelling & warmth;this is 1 of 7 pt of this facility to have an adverse exp p/vax lot#4978167;									U	10/01/1997	10/01/1997	0		PVT	PVT	unk	NONE		~ ()~~~In patient	897349007L	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4978167~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109309	03/26/1998	AZ				U	11/06/1997	pt recv vax & devel an inj site rxn characterized by redness, swelling & warmth;this is 1 of 7 of this facility to have an adverse exp p/vax lot# 4978167									U	10/01/1997	10/01/1997	0		PVT	PVT	unk	NONE		~ ()~~~In patient	897349008L	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4978167~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109310	03/26/1998	AZ				U	11/06/1997	pt recv vax & devel an inj site rxn characterized by redness, swelling & warmth;this is 1 of 7 employees of this facility to have an adverse exp p/vax lot# 4978167;									U	10/01/1997	10/01/1997	0		PVT	PVT	unk	NONE		~ ()~~~In patient	897349009L	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4978167~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109311	03/26/1998	AZ				U	11/06/1997	pt recv vax & devel an inj site rxn characterized by redness, swelling & warmth;This is 1 of 7 pt of this facility to have an adverse exp p/vax lot#									U	10/01/1997	10/01/1997	0		PVT	PVT	unk	NONE		~ ()~~~In patient	897349010L	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4978167~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109312	03/26/1998	AZ				U	11/06/1997	pt recv vax & devel an inj site rxn characterized by redness, swelling & warmth;this is 1 of 7 pt from this facility to have an adverse exp p/vax lot# 4978167;									U	10/01/1997	10/01/1997	0		PVT	PVT	unk	NONE		~ ()~~~In patient	897349011L	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4978167~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109313	03/26/1998	AZ				U	11/06/1997	pt recv vax & exp h/a & nausea;pt was seen by MD dx a streptococcal infect & prescribed an antibiotic & APAP #3;began to improve p/1wk;				Y					U	10/01/1997	10/01/1997	0		PVT	PVT	unk	NONE		~ ()~~~In patient	897349012L	1						1	Headache; Nausea	FLU3~PFIZER\WYETH~4978167~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109315	03/26/1998	MI	38.0			F	11/19/1997	pt recv vax & devel inj site rxn characterized by blotchy redness, warmth & burning pain;pt recovered p/2 days;reporter indicated that lot# 4978149 was administered to pt & MD @ this sam facility w/o adverse exp;									Y	10/24/1997	10/24/1997	0		OTH	OTH	unk	unk		~ ()~~~In patient	897351001L	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4978149~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109316	03/26/1998	NY	37.0	37		F	12/08/1997	w/in 11 days p/vax pt devel a line of itchy welts on torso;the welts inc in size & extended to pt hip & back;unspecified blood tests & a skin biopsy were performed, leading to a dx of Well's synd;tx w/pred, w/some symptomatic improvement;				Y					U	10/28/1997	11/08/1997	11	skin biopsy reportedly consistent w/Well's synd;	OTH	OTH	Atenolol;Unspecifed TB screaning test 20OCT97 to 20OCT97;	NONE	tachycardia	~ ()~~~In patient	897351026L	1						1	Pruritus; Urticaria	FLU3~PFIZER\WYETH~4978167~4~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109317	03/26/1998	IL	13.0			M	12/05/1997	pt recv vax & devel inj site swelling which extended from the shoulder to the elbow;									U					PVT	PVT	unk	unk		~ ()~~~In patient	897351027L	1						1	Injection site oedema; Oedema peripheral	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109318	03/26/1998	WA	47.0	47		M	12/10/1997	pt recv vax & immed exp inj site pain;pain persisted as 10DEC97;this is 1 of 2 pt from this facility to exp inj site pain p/vax lot# 4978142;				Y					U	11/12/1997	11/12/1997	0		PVT	OTH	Famvir	unk		~ ()~~~In patient	897351029L	1						1	Injection site pain	FLU3~PFIZER\WYETH~4978142~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109319	03/26/1998	MA	19.0			M	10/31/1997	pt recv vax & awoke the next day w/a very puffy eye lid & was only able to open the eye halfway;2 days post vax the other eye became puffy;pt recovered by the 3rd day post vax;									Y					OTH	OTH	unk	unk		~ ()~~~In patient	897351030L	1						1	Eye disorder; Face oedema	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109320	03/26/1998	NY	50.0	50		F	12/08/1997	pt recv vax & exp a burning-type pain @ the inj site;pain persisted as of 8DEC & the MD suspected a psychological component;reporter indicated that pt stated vax was injected higher in arm than in past;				Y					U	10/18/1997	10/18/1997	0		PVT	PVT	NONE	NONE		~ ()~~~In patient	897351031L	1						1	Injection site pain; Injection site pain; Pain	FLU3~PFIZER\WYETH~4978139~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4978139~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0109320	03/26/1998	NY	50.0	50		M	12/08/1997	pt recv vax & exp a burning type pain @ inj site;pain persisted as of 8DEC97;pt was seen by MD who stated that event is d/t a pre existing impingement of the shoulder, not to vax;				Y					U	10/18/1997	10/18/1997	0		PVT	PVT	NONE	NONE	unspecified shoulder disorder	~ ()~~~In patient	897351032L	1						2	Injection site pain; Injection site pain; Pain	FLU3~PFIZER\WYETH~4978139~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4978139~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0109322	03/26/1998	MI	38.0			F	11/19/1997	pt. developed an injection site rxn with blotchy redness, warmth and burning pain. Pt recovered after 2 days.									Y	10/24/1997	10/24/1997	0		OTH	OTH	unk	unk		~ ()~~~In patient	897351033L	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4978149~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109323	03/26/1998	FL	53.0	53		F	12/05/1997	Within 15 minutes of vax, inject site rxn characterized by a red, raised, circular rash measuring 2 to 3 inches in diameter.									Y	11/21/1997	11/21/1997	0		OTH	OTH	unk	unk		~ ()~~~In patient	897351034L	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Oedema peripheral; Urticaria	FLU3~PFIZER\WYETH~4978211~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109324	03/26/1998	FL	67.0	67		F	12/05/1997	within 15 minutes, inject site rxn characterized by a red, raised, circular rash measuring 2 to 3 inches in diameter.									Y	11/20/1997	11/20/1997	0		OTH	OTH				~ ()~~~In patient	897351035L	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Oedema peripheral; Urticaria	FLU3~PFIZER\WYETH~4978211~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109325	03/26/1998	FL				U	12/05/1997	Within 15 mins, inject site rxn of red, raised, circular rash measuring 2 to 3 inches in diameter.									U	12/04/1997	12/04/1997	0		OTH	OTH				~ ()~~~In patient	897351036L	1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~4978211~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109326	03/26/1998	FL				U	12/05/1997	within 15 mins.a rxn at inject site of red, raised, circular rash measuring 2 to 3 inches in diameter.									U	12/04/1997	12/04/1997	0		OTH	OTH				~ ()~~~In patient	897351037L	1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~4978211~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109328	03/26/1998	WA	29.0	29		F	11/06/1997	pt recv vax & devel Injection site pain with impaired mobility of the arm; pt self treated w/hydrocodone w/o relief;to MD 27OCT97 @ which time pt cont to exp lt arm pain particularly w/movement;pa originated @ inj site & radiated to elbow;				Y					U	10/15/1997	10/15/1997	0		PVT	PVT	ortho-cept, ddavp twice daily, Benadryl, Imitrex, Minocin, Paxil, Excedrin	None	Migraines	~ ()~~~In patient	897352004L	1						1	Hypokinesia; Injection site pain; Pain	FLU3~PFIZER\WYETH~4978142~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109329	03/26/1998	NY				U	10/27/1997	pt recv vax & later that day  felt bad, & devel inject site rxn with redness and swelling.									U					PVT	OTH	unk	unk		~ ()~~~In patient	897358006L	1						1	Injection site hypersensitivity; Injection site oedema; Malaise	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~442519~UNK~IM A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0109330	03/26/1998	MT	25.0	25		F	12/15/1997	1 day p/vax pt w/a hx of latex allergy devel a rash both arms for 3 days;treated self w/oral DPH;									U	12/12/1997	12/13/1997	1		PVT	OTH	Oral contraceptives		Latex allergy diagnosed 11/97	~ ()~~~In patient	898006023L	1						1	Rash	FLU3~PFIZER\WYETH~~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109331	03/26/1998	OR				F	12/15/1997	One week after inject,  pt devel dermatitis both arms, then to both legs.pt recv unspecified tx;As of 15DEC sl improvement was noted;				Y					U	11/19/1997	11/26/1997	7		OTH	OTH	unk	unk		~ ()~~~In patient	898006024L	1						1	Rash	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109332	03/26/1998	OK				U	11/05/1997	pt recv vax & devel inject site rxn with redness, induration, warmth and soreness.									U	11/01/1997	11/01/1997	0		OTH	OTH	unk	unk		~ ()~~~In patient	898006026L	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4978185~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109333	03/26/1998	RI	60.0			M	11/12/1997	Patient received vax Nov/10/97. 2 days later patient presented to the ER and was dx with cellulitis of the left arm.				Y					U	11/10/1997	11/12/1997	2		PVT	PVT	unk	unk		~ ()~~~In patient	898006027L	1						1	Cellulitis	FLU3~PFIZER\WYETH~~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109334	03/26/1998	FL				U	12/01/1997	Inject site rxn of redness, swelling and pain. Unable to lift arm. This is 1 of 2 patients from this facility to develop an inject site rxn									U					PVT	OTH	unk	NONE		~ ()~~~In patient	898006032L	1						1	Hypokinesia; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109335	03/26/1998	FL				U	12/01/1997	Patient developed and inject site rxn of redness, swelling & pain, and unable to lift arm. This is 1 of 2 patients from this facility to develop an injection site rxn following vax.									U					PVT	PVT	unk	NONE		~ ()~~~In patient	898006033L	1						1	Hypokinesia; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0109336	03/26/1998	PA	42.0	42		F	10/22/1997	pt recv vax & devel an inj site rxn characterized by induration, swelling, itching, redness & warmth;pt recovered;this is 1 of 8 pt of this facility to devel an inj site rxn p/vax lot#4978139;									Y	10/20/1997	10/20/1997	0		PVT	OTH	unk	NONE		~ ()~~~In patient	898007021L	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4978139~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109337	03/26/1998	PA	50.0	50		F	10/22/1997	2 days after receiving vax on 10/20/97, patient developed inject site rxn of induration, swelling,  itching, redness and warmth. This is 1 of 8 employees of the facility to develop and inject site using lot #4978139									Y	10/20/1997	10/22/1997	2		PVT	OTH	Verelan	NONE		~ ()~~~In patient	898007022L	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4978139~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109338	03/26/1998	PA				F	10/22/1997	One day following vax, patient developed inject site rxn of induration, swelling, itching, redness, and warmth. This is 1 of 8 employees of this facility to develop an injection site rxn. with lot# 4978139									Y	10/20/1997	10/21/1997	1		PVT	OTH	unk	NONE		~ ()~~~In patient	898007023L	1						1	Injection site hypersensitivity; Injection site mass; Oedema; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4978139~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109339	03/26/1998	PA	37.0	37		M	10/22/1997	Patient developed inject site rxn of redness and swelling.  This is 1 of 8 employees of this facility to develop and inject site rxn following vax with lot #4978139.									Y	10/20/1997	10/21/1997	1		PVT	OTH	NONE	NONE	Non-insulin dependent diabetes mellitus; allergic to penicillin, Bactrim, bee venom	~ ()~~~In patient	898007024L	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4978139~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109340	03/26/1998	PA	25.0	24		F	10/22/1997	Pt. devel inject site rxn w/redness & swelling. This is 1 of 8 employees of this facility to devel inject site rxn with lot# 4978139									Y	10/20/1997	10/20/1997	0		PVT	OTH	unk	NONE		~ ()~~~In patient	898007025L	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4978139~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109341	03/26/1998	PA				F	10/22/1997	Pt devel inject site rxn with soreness at inject site, she is 1 of 8 employees at this facility to devel inject site rxn with lot #4978139									Y	10/20/1997				PVT	OTH	unk	NONE		~ ()~~~In patient	898007026L	1						1	Injection site pain	FLU3~PFIZER\WYETH~4978139~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109342	03/26/1998	PA				F	10/22/1997	Pt devel inject site rxn with soreness at the inject site. This is 1 of 8 employees of this facility to devel inject site rxn following receipt  of vax with lot# 4978139.									Y	10/20/1997				PVT	OTH	unk	NONE		~ ()~~~In patient	898007027L	1						1	Injection site pain	FLU3~PFIZER\WYETH~4978139~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109343	03/26/1998	FL				F	12/30/1997	Pt devel influenza A infect 2 months after vax, Dx was made using Directigen Flu A Test, performed at the MD office. This was 1 of 2 patient from this site to devel influenza A 2 months after vax with lot# 4978151.				Y					Y	10/01/1997	12/26/1997	86	26DEC97 directigen flu A text positive;	PVT	OTH	unk	unk		~ ()~~~In patient	898008004L	1						1	Drug ineffective; Infection	FLU3~PFIZER\WYETH~4978151~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109344	03/26/1998	FL				F	12/30/1997	Two mo after receiving vax, pt devel influenza A infect, dx made Directigen Flu A Test performed in the MD office. This is 1 of 2 patients from this site to devel influenza A 2 mo following vax with lot #4978151.				Y					Y	10/01/1997	12/26/1997	86	26DEC97 Directigen flu A test positive;	PVT	OTH	unk	unk		~ ()~~~In patient	898009005L	1						1	Drug ineffective; Infection	FLU3~PFIZER\WYETH~4978151~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109345	03/26/1998	AR	40.0			F	12/11/1997	pt recv vax 11OCT97 & also sustained a needle stick injury 11OCT;because of the needle stick pt was tested for HIV;results were indeterminate;pt was retested for HIV 28NOV;results were again indeterminate;11DEC SUDS test neg for HIV;									U	10/11/1997			11OCT97 unspecified test for HIV-indeterminate;28NOV97 unspecified test for HIV-indeterminate;11DEC97 SUDS test for HIV negative;	PVT	OTH	HEP B vax	needle stick		~ ()~~~In patient	898009006L	1						1	Infection	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109346	03/26/1998	NY				U	12/18/1997	pt recv vax 24NOV97 & 2 days post vax an unspecified HIV test was positive;however, a western blot was negative;the reporter indicated that this pt prior HIV test in 1995 was negative;									U	11/24/1997	11/26/1997	2	26NOV97 unspecified HIV test-positive;western blot negative	OTH	OTH	unk	unk		~ ()~~~In patient	898009008L	1						1	Infection	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109347	03/26/1998	MI	66.0	66		M	12/12/1997	pt recv vax & devel persistent aches & pains in both arms & shoulders;				Y					U	10/15/1997				PUB	PUB	unk	NONE		~ ()~~~In patient	898009009L	1						1	Arthralgia; Hypertonia; Muscle spasms; Myalgia; Pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109348	03/26/1998	TX	78.0	78		F	12/16/1997	pt recv vax & exp pain @ the inj site;pain persisted 6wk post vax;tx w/indocin w/o relief;pt was also treated w/Darvocet;				Y					Y	10/04/1997	12/03/1997	60		OTH	OTH	unk	unk	parkinson's disease	~ ()~~~In patient	898009011L	1						1	Injection site pain	FLU3~PFIZER\WYETH~4978160~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109350	03/26/1998	AR	60.0			F	11/24/1997	pt recv vax 27SEP97 & 24OCT pt began therapy w/sulindac (mylan);27OCT exp heartburn, gastric reflux, SOB, dry cough & hoarseness;discontinued sulindac therapy & sx began to resolve;									U	09/27/1997	10/27/1997	30		OTH	OTH	Hydrochlorothiazide;vitamins	unk	fibromyalgia, panic disorder, mitral valve prolapse, arthritis, allergy to chicken, poss systemic lupus erythematosus	~ ()~~~In patient	898009015L	1						1	Cough; Dyspnoea; Gastrointestinal disorder; Laryngitis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109351	03/26/1998	NV	20.0			F	12/10/1997	1wk p/vax pt exp memory loss, migraines & bilat lower extremity weakness;all neuro exam negative;sx persisted as of 10DEC;				Y					U	10/10/1997	10/17/1997	7		OTH	OTH	unk	NONE		~ ()~~~In patient	898009017L	1						1	Amnesia; Migraine; Myasthenic syndrome	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109352	03/26/1998	NC	42.0	42		F	11/12/1997	pt recv vax 23OCT97 & 14NOV (22 days post vax) pt exp lt eye pain, dec visual acuity of the lt eye, h/a & dizziness;				Y					Y	10/23/1997	11/04/1997	12		OTH	OTH	Motrin PRN	NONE		~ ()~~~In patient	898016015L	1						1	Dizziness; Eye pain; Headache; Optic neuritis; Visual disturbance	FLU3~PFIZER\WYETH~4978219~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109353	03/26/1998	AR	45.0	45		F	11/12/1997	1 day p/vax pt exp myalgia;As of 11NOV the myalgia cont & pt was unable to work;this is 1 of 5 pt from this facility to have an adverse exp p/vax w/lot# 4978216;									Y	10/19/1997	10/20/1997	1		PVT	PVT	unk	NONE		~ ()~~~In patient	898016016L	1						1	Arthralgia; Asthma; Dyspnoea; Myalgia; Serum sickness	FLU3~PFIZER\WYETH~4978216~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109354	03/26/1998	AR				U	11/12/1997	pt recv vax & devel an inj site rxn;									U					PVT	PVT	unk	unk		~ ()~~~In patient	898016017L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~4978216~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109355	03/26/1998	AR				U	11/12/1997	pt recv vax & devel an inj site rxn;this is 1 of 5 pt from this facility to have an adverse exp p/vax w/lot# 4978216;									U					PVT	PVT	unk	unk		~ ()~~~In patient	898016018L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~4978216~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109356	03/26/1998	AR				U	11/12/1997	pt recv vax & devel an inj site rxn;this is 1 of 5 pt from this facility to have an adverse exp p/vax w/lot# 4978216;									U					PVT	PVT	unk	unk		~ ()~~~In patient	898016019L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~4978216~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109357	03/26/1998	AR				U	11/12/1997	pt recv vax & devel an inj site rxn;this is 1 of 5 pt from this facility to have an adverse exp p/vax w/lot# 4978216;									U					PVT	UNK	unk	unk		~ ()~~~In patient	898016020L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~4978216~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109358	03/26/1998	NJ	48.0	48		F	11/05/1997	w/in a few min of vax pt exp gen itching, felt hot all over, devel lumps @ site of vax;w/in 2-3hr devel swelling & pain @ vax site which extended from neck to fingers;seen by MD rx DPH & claritin;swelling improved but painful area ecchymosi				Y					U	10/31/1997	10/31/1997	0		PVT	PVT	NONE	NONE		~ ()~~~In patient	898035001L	1						1	Ecchymosis; Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Pain; Pruritus; Vasodilatation; Ecchymosis; Injection site mass; Injection site oedema; Injection site pain; Oedema peripheral; Pain; Pruritus; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~444068~1~IM~LA~PNEUMO (PNU-IMUNE)~1|FLU3~MEDEVA PHARMA, LTD.~E32779A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~PFIZER\WYETH~444068~1~IM~RA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0109360	03/26/1998	LA	43.0	43		F	10/14/1997	2hr p/vax pt devel an inj site rxn characterized by a 40mm by 45mm area of redness, warmth, itching & tenderness;pt recovered 3 days;this is 1 of 3 pt from this site to devel an inj site rxn p/vax w/lot# 4978185									Y	10/09/1997	10/09/1997	0		OTH	OTH	NONE	NONE		~ ()~~~In patient	898035004L	1						1	Injection site hypersensitivity; Injection site pain; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4978185~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109361	03/26/1998	LA	51.0	51		F	10/14/1997	1 day p/vax pt exp pain @ the inj site;pt was seen by a MD on 25OCT & treated w/anti-inflammatory med;pain persisted as of 20NOV;this is 1 of 3 pt from this site to devel an inj site rxn p/vax w/lot# 4978185;				Y					U	10/09/1997	10/10/1997	1		OTH	OTH	NONE	NONE		~ ()~~~In patient	898035005L	1						1	Injection site pain	FLU3~PFIZER\WYETH~4978185~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109362	03/26/1998	CO	41.0	41		F		19 days p/vax pt devel a burning, itching rash on lt arm, dorsum wrist & shoulder;also devel scattered vesicles on lt lateral chest wall in a T4-6 dermatome distribution;seen by MD & recovered;this is 1 of 2 pt to devel rash p/vax				Y					Y	10/29/1997	11/17/1997	19		MIL	MIL	Claritin;Entex	sinus sx	hayfever, childhood food allergies, chronic sinus condition	~ ()~~~In patient	898035009L	1						1	Dermatitis bullous; Pain; Pruritus; Rash	FLU3~PFIZER\WYETH~4978171~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109363	03/26/1998	MT	44.0	44		M	10/06/1997	immed p/vax pt exp severe arm pain from shoulder to hand;pain resolved p/20min;this is 1 of 3 pt of this facility to exp arm pain p/vax lot# 4978143									Y	10/06/1997	10/06/1997	0		PVT	PVT	NONE	NONE		~ ()~~~In patient	898036001L	1						1	Pain	FLU3~PFIZER\WYETH~4978143~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109364	03/26/1998	MT	42.0	41		F	10/06/1997	immed p/vax pt exp severe arm pain from shoulder to hand;pain resolved p/20-30min;this is 1 of 2 pt of this facility to exp arm pain p/vax lot# 4978143;									Y	10/06/1997	10/06/1997	0		OTH	PVT	unk	NONE		~ ()~~~In patient	898036002L	1						1	Pain	FLU3~PFIZER\WYETH~4978143~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109365	03/26/1998	NY	53.0	53		F	10/27/1997	1 day p/vax pt devel an inj site rxn characterized by a 2-inch by 3-inch area of redness & induration;pt seen by MD:over next 2 days the redness & induration extended to elbow;rxn began to resolve, 4 days post vax;				Y					Y	10/27/1997	10/27/1997	0		PVT	OTH	unk	NONE	allergies to Advil and Motrin (abdominal pain), codeine (vomiting), sulfa  (hives), PABA and niacin (rash)	pt devel an inj site rxn characterized by redness & induration p/vax;~ ()~~~In patient	898040021L	1						1	Injection site hypersensitivity; Injection site mass; Myalgia	FLU3~PFIZER\WYETH~4978139~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109366	03/26/1998	WA	25.0			F	12/06/1997	pt recv vax & devel swelling & tenderness of entire rt shoulder;a knot was noted @ the inj site;the swelling, tenderness & knot resolved p/3-4 days;1DEC97 (32 days post vax) rt shoulder became painful & warm;dx sterile abscess;				Y					U	10/30/1997				OTH	OTH	unk	unk		~ ()~~~In patient	898043008L	1						1	Abscess; Injection site mass; Oedema peripheral; Osteoarthritis; Pain; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109367	03/26/1998	TN	59.0			M	11/29/1997	pt recv vax 26NOV97 & that evening exp aching of the back of neck;the next day the rt side of neck was sore & rt shoulder was painful;treated self w/medrol dosepak, SOMA, hydrocodone w/APAP & hot compresses;pain persisted as of 29NOV97;									U	11/26/1997	11/26/1997	0		OTH	OTH	unk	unk	cervical osteoarthritis	~ ()~~~In patient	898043009L	1						1	Myalgia; Pain	FLU3~PFIZER\WYETH~4978219~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0108979	03/31/1998	TX	63.0	63		M	02/23/1998	cont severe pain in lt arm, lt shoulder, lt shoulder blade & numb forefinger lt hand;had numerous prescription drugs;none touched the pain;had 8 physical therapy sessions;pt given meds;pt states finger is still numb still taking med;				Y				Y	N	10/24/1997	10/27/1997	3		UNK	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	TX98031	1						1	Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~7F81735~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0108980	03/31/1998	TX	57.0	57		F	02/23/1998	cont severe pain & throbbing in lt arm between elbow & shoulder;had full body bone scan, complete neuro test;motor sensory, reflex each nerve, paraspinous;5 sessions of physical therapy;still in pain;cannot find anything wrong;				Y				Y	N	10/24/1997	10/27/1997	3		OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	TX98032	1						1	Pain	FLU3~CONNAUGHT LABORATORIES~7F81735~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0109021	04/01/1998	CA	45.0	44		F	03/23/1998	GI sx;w/in a few days c/o neuro signs & sx described as pain, fatigue, sleeplessness, weakness, GI sx;no complaint of erythema or rash;fibromyalgia;exp arthralgia;c/o wide spread joint discomfort;stiffness;misjudging step;				Y	Y				N	10/28/1997			pt tested positive for parvo (virus);AST/SGOT 10;LDH 105;cholesterol 205;LDL chol direct 130;total chol/HDL 5.8;RBC 3.88;MCV 102.2;MCV 102.2;MCH35.3	OTH	PVT		NONE	NONE	~ ()~~~In patient	U1998000410	1						1	Accommodation disorder; Anaemia; Arthralgia; Arthropathy; Asthenia; Gastrointestinal disorder; Hypercholesterolaemia; Myalgia	FLU3~CONNAUGHT LABORATORIES~7F81741~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0109022	04/01/1998	CA	43.0	43		F	03/23/1998	aplastic crisis, parvovirus infect;pt c/o neuro signs & sx consisting of pain, fatigue, sleeplessness, weakness, malaise & GI sx;c/o erythema or rash;positive parvo;			Y	Y					N	10/28/1997			platelet count 441;CPK total 146;Parvovirus B 19 IGG 39;Uricid acid 1.0;GGT 76;RBC 3.28;hgb 9.7;HCT 28.7;lymph 19;cholesterol 217;total protein 8.2;	OTH	PVT		NONE		~ ()~~~In patient	U1998000420	1						1	Asthenia; Gamma-glutamyltransferase increased; Gastrointestinal disorder; Infection; Insomnia; Malaise; Pain; Thrombocythaemia	FLU3~CONNAUGHT LABORATORIES~7F81741~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0109033	04/01/1998	LA	76.0	76		F	03/31/1998	bumping, muscle twitching & numbness in arm, arm can hardly be used;			Y	Y				Y	N	10/20/1997	11/03/1997	14	NOEN	PUB	OTH	NONE	NONE	high BP	~ ()~~~In patient		1						1	Hypokinesia; Muscle twitching; Paraesthesia; Skin nodule; Injection site hypersensitivity; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~MEDEVA PHARMA, LTD.~E3257FA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|TD~CONNAUGHT LABORATORIES~7E91639~1~IM~LA~TD ADSORBED (NO BRAND NAME)~2	USA	Life Threatening,Disabling	Influenza
0109548	04/06/1998	TX	83.0			M	03/31/1998	pt recv vax 1OCT97 & INR of 15.6 reported 27OCT97 requiring ER visit & SC vit K;pt reported no bleeding;					Y					10/01/1997	10/27/1997	26	1OCT97 INR=1.3, increased;coumadin from 8mg/wk to 9mg /wk;10OCT97 INR 2.5, cont 9mg/wk;27OCT97 INR 15.6;	UNK	UNK	Cardura;Coumadin;CA of gallbladder outpatinet		no allergies;coumadin dose returned to 9mg/wk w/INR in orthertherapeutic rang or below (NOV97-present);	~ ()~~~In patient		1						1	Coagulation time prolonged; Condition aggravated	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0109604	04/09/1998	PA	40.0	40		F	04/03/1998	Developed acute urticaria now 5 months in duration w/prolonged use of prednisone which caused complication; skin has been permanently damaged from hives & cellulitis as result from flu vaccine 97/98.			Y	Y					N	10/03/1997	10/17/1997	14	all blood work;immunologial test/biopsy of hives x 2;	PUB	PVT	SYNTHROID	hypothyroidsim	NONE			1						1	Cellulitis; Skin disorder; Urticaria; Hypersensitivity; Urticaria	FLU3~PFIZER\WYETH~4978144~1~UN~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4978144~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Life Threatening	Influenza
0109675	04/10/1998	WI	47.0	47		F	10/15/1997	pt recv vax 10OCT97 & approx 2-3hr later devel hives & SOB;				Y					Y	10/10/1997	10/10/1997	0		PVT	PVT		NONE	PCN, NSAID, ultram, sulfa, varapamil	pt devel hives & SOB w/dose 2 of flu shot;~ ()~~~In patient		1						1	Dyspnoea; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81776~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~443185~1~SC~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0109141	04/13/1998	MI	59.0	59		F	10/10/1997	lt arm tender on Tuesday evening, devel swelling of upper arm below inj site that is evident 3 days later;inj site appears reddened & has indentation approx 20mm across;									Y	10/06/1997	10/07/1997	1		PUB	UNK		NONE	NONE	~ ()~~~In patient	MI98025	1						2	Injection site atrophy; Injection site hypersensitivity; Injection site oedema; Injection site pain; Injection site hypersensitivity; Injection site mass; Injection site oedema; Pain	FLU3~PFIZER\WYETH~4978174~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4978174~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0109709	04/13/1998	CO	50.0	50		F	12/23/1997	soreness, swelling of deltoid-progressed to shoulder joint pain & limited ROM;				Y					U	10/27/1997	10/27/1997	0		PUB	PUB	Premarin only		some ATB & pain killers (does not know which)	~ ()~~~In patient	CO98001	1						1	Arthralgia; Hypokinesia; Oedema peripheral; Pain	FLU3~PFIZER\WYETH~4978140~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0109720	04/13/1998	CO	54.0	54		F	11/30/1997	46hr p/vax devel fever & severe abd pain, h/a;									Y	10/29/1997	10/30/1997	1		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	CO98002	1						1	Abdominal pain; Headache; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81740~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0109721	04/13/1998	CO	46.0	46		F	01/08/1998	3-4hr p/vax noted hoarse cough;1hr later painful cough, very tight chest/wheezing;lasted all evening-3-4hr ent to bed-better in AM;									Y	10/27/1997	10/27/1997	0		PVT	PVT	NONE	NONE	allergy PCN	~ ()~~~In patient	CO98003	1						1	Asthma; Chest pain; Cough; Dysphonia; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~7F81740~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0109750	04/15/1998	NY				M	03/26/1998	pt recv vax & devel GBS;pt has been unable to work for 4mo & hosp as of 27MAR98;reporter declined to provide further info;									U		11/10/1997			OTH	OTH	unk	unk		~ ()~~~In patient	898086020L	1						1	Guillain-Barre syndrome	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0109756	04/15/1998	NY	36.0			F	03/25/1998	pt recv vax & exp progressive leg weakness, numbness below the chest & urinary retention;5wk post vax dx of acute transverse myelitis made;pt hosp & treated w/IV med;6mo later bowel incontinence & exercise induced leg paresthesias;					Y				Y				MRI of the cervical & rostral thoracic spine: mild diffuse fusiform enlargement of the spinal cord extending from C-3 to visualized upper thoracic levels;CSF 84 WBC (90% lymph, 10% mono), 3 erythrocytes, total protein 96, glucose nl;	OTH	OTH	unk	unk		~ ()~~~In patient	898086035A	1						1	CSF test abnormal; Depressed level of consciousness; Faecal incontinence; Myasthenic syndrome; Myelitis; Paraesthesia; Urinary retention	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0109766	04/16/1998	WV	44.0			F	03/30/1998	pt recv vax & devel cellulitis @ the inj site & myositis of the lt deltoid;initially was treated on an out-patient basis w/ampicillin then dicloxacillin;7 days post vax;hosp for 2 days & recv IV med;drainage of small mass in lt deltoid;				Y	Y				Y				WBC count 11,000 w/69% polymorphonuclear cells, 21% lymphocytes, 6.9% monocytes, 1.8% eosinophils, 1.2% basophils;creatinine kinase 52;ESR 15;CT scan soft tissue swelling;cult of deltoid drainage +for agrobacterium radiobacter & haemophilu	OTH	OTH	unk	unk		~ ()~~~In patient	898091048A	1						1	Abscess; Blood creatine phosphokinase increased; Cellulitis; Infection; Injection site hypersensitivity; Laboratory test abnormal; Leukocytosis; Oedema peripheral	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0109780	04/16/1998	GA	61.0	61		F	02/23/1998	6NOV97 noticed a dark purple stain on breast w/tenderness & swelling of both breast w/2 swollen gland on lt arm-tx w/anti inflammatory drugs & ATB;test negative but sx persist;				Y					U	10/27/1997	11/06/1997	10	mammogram, ultra sound, biopsy;	PUB	PUB	Prempro	NONE	NONE	NONE~ ()~~~In patient	GA98020	1						1	Breast pain; Lymphadenopathy; Oedema; Purpura	FLU3~CONNAUGHT LABORATORIES~7F81832~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0109794	04/17/1998	TX	83.0	83		M	04/10/1998	pt recv vax 1OCT97 & INR of 15.6 reported 27OCT97 requiring ER visit &  vitamin K;no bleeding reported;				Y					Y	10/01/1997	10/15/1997	14	1OCT97 INR 1.3 coumadin inc from 8mg to 9mg/wk;10OCT97 INR 2.5, cont 9mg/wk;INR normalized & stayped on 9mg/wk	PVT	PVT	Couumadin	NONE		~ ()~~~In patient		1						1	Coagulation time prolonged; Coagulation time shortened	FLU3~PFIZER\WYETH~4978185~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0110265	04/17/1998	TX	1.0	1	.0	M	04/15/1998	07Nov96 pt recv 1 dose vax. 20Feb98 pt devel approx 20-25 small papule-like lesions. 50 percent had vesicles or crusts.									Y	11/07/1996	02/20/1998	470	None	PVT	PVT			Benadryl allergy; amoxicillin alergy; asthma; reactive airway disease	No relevant data~ ()~~~In patient	WAES98021881	1						1	Dermatitis bullous; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0207D~1~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0770D~1~SC~~VARICELLA (VARIVAX)~1	USA		Influenza
0102893	04/20/1998	CO	45.0	45		F		pt recv vax 1OCT97 8-830AM & exp ears & throat itching, nausea, dizziness, weak, throat swelling;seen in hosp? tx w/steroids x 3 days;			Y	Y					Y	10/01/1997	10/01/1997	0	skin test to egg negative;skin test to vaccine positive day p/test;tx w/ steroids	OTH	UNK	NONE	NONE		NONE~ ()~~~In patient		1						3	Asthenia; Dizziness; Ear disorder; Laryngospasm; Nausea; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81862~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Life Threatening	Influenza
0109889	04/21/1998	CA	51.0	51		F		flu sx 24hr later-fever, chills, aches-later congestion in sinus & chest;									Y	10/15/1997	04/16/1998	183		PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Influenza; Myalgia; Pharyngitis; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0109033	04/27/1998	LA	76.0	76		F	11/10/1997	2wk p/vax couple blisters formed @ inj site on lt arm (where Td given); also 2 inches below site a rash formed;MD gave deltasone & valtres;pt also c/o pain in arm;									Y	10/20/1997	11/03/1997	14	NONE	PUB	PUB	BP meds;Thyroid meds	NONE	breaks out w/rash if handles white potatoes;elevated BP	NONE~ ()~~~In patient	LA980403	1						2	Hypokinesia; Muscle twitching; Paraesthesia; Skin nodule; Injection site hypersensitivity; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~MEDEVA PHARMA, LTD.~E3257FA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|TD~CONNAUGHT LABORATORIES~7E91639~1~IM~LA~TD ADSORBED (NO BRAND NAME)~2	USA		Influenza
0110231	04/27/1998	FL	62.0	62		F	04/09/1998	pt recv vax 28OCT97 & was hosp 1APR98 & dx w/pneumonia;the causative organism was not known by the reporter;					Y	7			Y	10/28/1997	04/01/1998	155		PUB	PVT	unk	NONE		~ ()~~~In patient	898100004N	1						1	Pneumonia	FLU3~CONNAUGHT LABORATORIES~7F81802~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~441213~1~~LA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0110233	04/27/1998	MS				M	02/06/1998	pt recv vax & devel subacute encephalopathy manifested by fever, status epilepticus & apnea;pt hosp & tx w/meds;made a remarkable recovery but had residual minimal hemiparesis & truncal ataxia;dx chediak-Higashi synd triggered by vax					Y				N				MRI of brain: signal abnormality in pons, midbrain, cerebellum, cerebellar peduncles, cortex & deep white matter regions consistent w/petechial hemorrhage & infarct;CSF pleocytosis w/T cell predominance;virology studies for EBV,herpes & CMV	OTH	OTH	unk	unk	Chediak-Higashi synd w/diffuse polyneuropathy of an axonal degeneration variety;hosp staphylococcal bacteremia;	~ ()~~~In patient	898099036N	1						1	Coordination abnormal; Encephalopathy; Grand mal convulsion; Hemiplegia; Neuropathy; Optic atrophy; Petechiae; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0110375	04/27/1998	MT				U	11/12/1997	pt recv vax & immed c/o numbness of skin to back of forearm & hand & states had dizziness p/1hr;eval by MD;no specific therapy as of 12NOV97, reports that numbness & dizziness resolving;14NOV97 c/o swollen glands;				Y					Y		11/10/1997		NA	PVT	PVT		NA		~ ()~~~In patient		1						1	Dizziness; Lymphadenopathy; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0110508	04/30/1998	MA	57.0	56		F	04/27/1998	pt devel sx consistent w/GBS w/in 1 2k of vax;as a result pt sought ER care;pt later adm to rehab on 26DEC96 for 37 days of in-patient care;pt resulting dx is GBS;				Y	Y			Y	N	11/19/1996	12/02/1996	13	studies performed @ hosp	PVT	PUB	glyburide	NONE		~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~6F71226~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0110646	05/05/1998	CO	48.0	48		F	01/30/1998	muscle  twitching & jerking occurring primarily during sleep;seen by neurologist who dx myoclonus;										01/10/1998	01/13/1998	3	NONE	PVT	PVT	corizide;Corgaard	thiazide indeced dermatitis;	HTN, recurrent sinusitis	~ ()~~~In patient		1						1	Muscle twitching; Myoclonus	FLU3~CONNAUGHT LABORATORIES~7F81898~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0110945	05/15/1998	OH	5.0	5		F	01/12/1998	Within 24 hr of vax, pt devel urticaria at site of Acel-Immune & upper left arm. Pt recovered p/36 hr.									Y	12/05/1997	12/12/1997	7		PVT	PVT	none	none	allergic to amoxicillin and duricef	~ ()~~~In patient	898040012L	1						1	Injection site hypersensitivity; Urticaria	DTAP~PFIZER\WYETH~440763~UNK~IM~LA~DTAP (ACEL-IMUNE)~1|FLU3~CONNAUGHT LABORATORIES~7F81723~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~SMITHKLINE BEECHAM~194A2~1~IM~RA~HEP A (HAVRIX)~1|OPV~PFIZER\WYETH~449580~UNK~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~1	USA		Influenza
0109279	05/20/1998	MI	49.0	48		F	11/10/1997	severe h/a, nausea, low grade fever, chills, sweats, elevated liver enzymes, weight loss lasted 6-8wk;				Y					Y	10/08/1997	10/09/1997	1	CAT scan of lliver, LFT	MIL	PUB	Atenolol	NONE	sinus allergies, fruit allergies	NONE~ ()~~~In patient		1						2	Anorexia; Asthenia; Headache; Hepatic function abnormal; Nausea; Pyrexia; Weight decreased; Headache; Hepatic function abnormal; Hyperhidrosis; Nausea; Pyrexia; Weight decreased	FLU3~PFIZER\WYETH~4978197~7+~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~~1~A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0110982	05/20/1998	TX	45.0	45		F	04/10/1998	NOV97 numbness plantar rt big toe;JAN98 to ball of same foot lt side numbness lt index finger & thumb started;25FEB numbness both legs w/tingling;dx disturbance of sensation & cervical pain;hosp dx post vax autoimmune transverse myelitis;					Y	4			Y	10/16/1997	11/01/1997	16	IgG synthesis index on spinal fluid;MIR, spinal tap,	PUB	PVT	Premarin & calcium			~ ()~~~In patient		1						1	CSF test abnormal; Depressed level of consciousness; Immune system disorder; Immunoglobulins increased; Myelitis; Neck pain; Paraesthesia	FLU3~PFIZER\WYETH~4978140~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0108666	05/27/1998	MT	50.0	50		M	02/02/1998	pt recv vax & a couple of days p/vax pt exp numbness of the rt foot, which persisted for 1-2mo;pt was seen by MD who dx peripheral neuropathy;pt cont to exp diff w/rt ankle & is unable to lift foot;				Y					N	10/03/1997				PVT	PVT	Triamterene, Vasotec	NONE		~ ()~~~In patient	898093011L	1						2	Hypokinesia; Neuropathy; Paraesthesia; Paralysis; Vasculitis; Hypokinesia; Hypotonia; Myasthenic syndrome; Neuropathy; Paraesthesia; Hypokinesia; Neuropathy; Paraesthesia; Paralysis; Vasculitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~3	USA	Emergency room visit	Influenza
0109604	05/27/1998	PA	41.0	40		F	01/30/1998	Pt recvd vax & devel allergic rxn of hives & tx w/prednisone, dyazide, Tagament,doxepin & Zyrtec. Hives resolved. Recur when prednisone dosage is reduced to less than 20md/day.				Y					U	10/03/1997	10/17/1997	14		PVT	OTH	synthroid 250 mcg daily	none		~ ()~~~In patient	898062006L	1						2	Cellulitis; Skin disorder; Urticaria; Hypersensitivity; Urticaria	FLU3~PFIZER\WYETH~4978144~1~UN~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4978144~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0111231	05/27/1998	OH				F	01/02/1998	pt recv vax & devel fever w/chills & shaking, sore throat & dizziness which persisted 7 wk post vax;				Y					U	11/01/1997	11/01/1997	0		PUB	OTH	unk	NONE		~ ()~~~In patient	898015012L	1						1	Chills; Dizziness; Pharyngitis; Pyrexia; Tremor	FLU3~PFIZER\WYETH~497212~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0111232	05/27/1998	MT	74.0	74		F	01/06/1998	pt recv vax OCT97 & DEC97 pt devel a influenza A infect;dx was made via an unspecified lab test;this is 1 of 3 pt from this site to devel influenza A p/vax;					Y	4			Y	11/05/1997	01/01/1998	57		PVT	OTH	UNK	unk	unk	~ ()~~~In patient	898016005L	1						1	Drug ineffective; Infection	FLU3~PFIZER\WYETH~4978172~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0111233	05/27/1998	MT				U	01/06/1998	pt recv vax OCT97 & DEC97 pt devel an influenza A infect;dx was made via an unspecified lab test;this is 1 of 3 pt from this site to devel influenza A following receipt of flu vax;					Y	4			Y	10/31/1997	01/03/1998	64		PVT	PVT	unk	unk	chronic obstructive pulmonary disease	~ ()~~~In patient	898016006L	1						1	Drug ineffective; Infection	FLU3~PFIZER\WYETH~4978172~7+~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0111234	05/27/1998	MT				U	01/06/1998	pt recv vax mid-OCT97;DEC97 pt devel an influenza A inj;dx was made via an unspecified lab test;this is 1 of 3 pt from this site to devel influenza A following receipt of flu vax lot# 4978172;									U	10/01/1997	12/01/1997	61		PVT	OTH	unk	unk		~ ()~~~In patient	898016007L	1						1	Drug ineffective; Infection	FLU3~PFIZER\WYETH~4978172~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0111235	05/27/1998	WY	50.0	50		F	01/21/1998	pt recv vax & devel migrating joint pain approx 3-4wk p/vax;the pain was reported to be greater in the lt shoulder than rt;testing for rheumatoid arthritis was positive but not conclusive;testing for lupus & other numerous blood test neg;				Y					U	10/16/1997	11/01/1997	16	testing for rheumatoid arthritis positive but not conclusive;testing for lupus reportedly negative;numerous blood tests: reportedly negative;WBC count elevated;	PUB	OTH	Propranolol	NONE	migraines	~ ()~~~In patient	898035006L	1						1	Arthralgia; Leukocytosis; Rheumatoid arthritis	FLU3~PFIZER\WYETH~4978174~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0111236	05/27/1998	MI	51.0	50		F	01/05/1998	Devel sore throat & inj site rxn of 4inch area erythema,warmth & tenderness.Resolved p/48 hr. 3 days p/vax pt devel malaise,  fever (99+), left arm weakness & arthralgia. Sx resolved p/1 wk. 01/98 pt exp arthralgia & extreme fatigue				Y					Y	11/03/1997	11/03/1997	0	11/29/97 : LDH= 847 units/L (normal, 300-618), Antinuclear antibody titer; negative, RA latex: negative	PVT	PVT	Estrogen replacement therapy	none		~ ()~~~In patient	898040015L	1						1	Arthralgia; Asthenia; Injection site hypersensitivity; Injection site pain; Malaise; Myasthenic syndrome; Pharyngitis; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4978200~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0111237	05/27/1998	PA	53.0	53		M	01/08/1998	2 days p/vax pt devel generalized hives. Pt seen by MD & tx w/Medrol Dosepak, Claritin, Hismanal & Zyrtec. Hives persisted as of 01/08/98.				Y					Y	10/31/1997	11/02/1997	2		PUB	OTH	none	none	non-insulin dependent diabetes mellitus	~ ()~~~In patient	898040018L	1						1	Urticaria	FLU3~PFIZER\WYETH~4978273~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0111238	05/27/1998	WA	53.0	53		F	02/05/1998	1 wk p/vax pt devel generalized rash of red,pruritic bumps.Pt seen by MD(allergist) & cause of rash not determined. Pt tx w/unspecified prescribed med. Exp most relief w/Benadryl oral & cream. Rash persisted as of 02/05/98.				Y					U	12/01/1997	12/01/1997	0		PVT	OTH	unknown	none	other skin reactions, for which no cause was found	~ ()~~~In patient	898049001L	1						1	Pruritus; Rash maculo-papular	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0111239	05/27/1998	FL	50.0	50		M	02/04/1998	Pt recvd vax 10/21/97. Approx Dec pt donated blood; RPR test was positive. Seen by MD 01/22/98; FTA test & RPR both negative.				Y					Y	10/21/1997	12/01/1997	41	12/97: RPR - positive,  01/22/98: RPR - negative, FTA - negative	PVT	OTH	none	none		~ ()~~~In patient	898049002L	1						1	Laboratory test abnormal; Laboratory test abnormal	FLU3~PFIZER\WYETH~4978219~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~445642~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~PFIZER\WYETH~4978219~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~445642~1~IM~LA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0111241	05/27/1998					F	01/13/1998	Pt recvd vax & devel inj site rxn of redness, itching & soreness. Recovered p/1-2 days. Of 36 employees,20 females exp this event. 2 of the pt recovered p/4 days. Others not identifiable.									Y					OTH	OTH	unknown	unknown		~ ()~~~In patient	898084001L	1						1	Injection site hypersensitivity; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~4978192~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0111242	05/27/1998	OH				U	01/13/1998	this nursing home pt devel a sl inj site rxn p/vax;this is 1of 2 reports from this facility of inj site rxn p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	898084007L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~4978192~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0111244	05/27/1998	PA	35.0	34		F	02/24/1998	approx 2mo p/vax pt was informed @ a blood donation ctr that tested positive for hepatitis B core antibody;pt was asymptomatic @ that time & remained asymptomatic;pt seen by MD who performed liver function test & hep panel MAR98 both neg;				Y					Y	10/01/1997	12/09/1997	69	9DEC97 positive hepatitis B core antibody test;MAR98 liver function tests normal;MAR98 hepatitis panel negative;	OTH	OTH	unk	unk		~ ()~~~In patient	898093012L	1						1	Hepatitis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0111245	05/27/1998	OH				F	02/09/1998	pt recv vax & devel an inj site rxn characterized by a 10-40cm area of redness & pain;pt recovered;this is 1 of 11 pt from this facility to devel an inj site rxn p/flu vax lot# 4978296;									Y	11/03/1997	11/03/1997	0		OTH	PUB	unk	NONE		~ ()~~~In patient	898093013L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4978296~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0111246	05/27/1998	OH				F	02/09/1998	pt recv vax & devel an inj site rxn characterized by a 10-40cm area of redness & pain;pt recovered;this is 1 of 111 pt from this facility to devel an inj site rxn p/flu vax lot# 4978296;									Y	11/03/1997	11/04/1997	1		OTH	PUB	unk	NONE		~ ()~~~In patient	898093014L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4978296~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0111247	05/27/1998	OH				F	02/09/1998	pt recv vax & devel an inj site rxn characterized by a 10-40cm area of redness & pain;pt recovered;this is 1 of 11 pt from this facility to devel an inj site rxn p/flu vax lot# 4978296;									Y	11/03/1997	11/04/1997	1		OTH	PUB	unk	NONE		~ ()~~~In patient	898093015L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4978296~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0111248	05/27/1998	OH				F	02/09/1998	pt recv vax & devel an inj site rxn characterized by a 10-40cm area of redness & pain;pt recovered;this is 1 of 11 pt from this facility to devel an inj site rxn p/flu vax lot# 4978296;									Y	11/08/1997	11/10/1997	2		OTH	PUB	unk	NONE		~ ()~~~In patient	898093016L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4978296~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0111249	05/27/1998	OH				F	02/09/1998	pt recv vax & devel an inj site rxn characterized by a 10-40cm area of redness & pain;pt recovered;this is 1 of 11 pt from this facility to devel an inj site rxn p/flu vax w/lot# 4978296;									Y	11/03/1997	11/04/1997	1		OTH	PUB	unk	NONE		~ ()~~~In patient	898093017L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4978296~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0111250	05/27/1998	OH				F	02/09/1998	pt recv vax & devel an inj site rxn characterized by a 10-40cm area of redness & pain;pt recovered;this is 1 of 11 pt from this facility to devel an inj site rxn p/flu vax lot#4978296;									Y	11/03/1997	11/03/1997	0		OTH	PUB	unk	NONE		~ ()~~~In patient	898093018L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4978296~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0111251	05/27/1998	OH				F	02/09/1998	pt recv vax & devel inj site rxn characterized by 10-40cm area of redness & pain;pt recovered;this is 1 of 11 pt from this facility to devel an inj site rxn p/flu vax lot#4978296;									Y	11/03/1997	11/04/1997	1		OTH	PUB	unk	NONE		~ ()~~~In patient	898093019L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4978296~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0111252	05/27/1998	OH				F	02/09/1998	pt recv vax & devel an inject site rxn characterized by a 10-40cm area of redness & pain;pt recovered;this is 1 of 11 pt from this facility to devel an inj site rxn p/flu vax w/lot#4978296;									Y	11/03/1997	11/04/1997	1		OTH	PUB	unk	NONE		~ ()~~~In patient	898093020L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4978296~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0111253	05/27/1998	OH				F	02/09/1998	pt recv vax & devel an inj site rxn characterized by a 10-40cm area of redness & pain;pt recovered;this is 1 of 11 pt from this facility to devel an inj site rxn p/flu vax w/lot#4978296;									Y	11/03/1997	11/04/1997	1		OTH	PUB	unk	NONE		~ ()~~~In patient	898093021L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4978296~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0111254	05/27/1998	OH				F	02/09/1998	pt recv vax & devel an inj site rxn characterized by a 10-40cm area of redness & pain;pt recovered;this is 1 of 11 pt from this facility to devel an inj site rxn p/flu vax w/lot#4978296;									Y	11/03/1997	11/04/1997	1		OTH	PUB	unk	NONE		~ ()~~~In patient	898093022L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4978296~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0111255	05/27/1998	NC	36.0			F	12/02/1997	pt recv vax & small inj site rxn devel on each leg;pt recovered;									Y				LHRT (allergy test) reportedly negative;Rast testing w/influenza virus vaccine, egg & egg white was inconclusive;	PVT	PVT	NONE	NONE		pt devel inj site rxn p/95/96 & 96/97 flu vax;~ ()~~~In patient	898100001L	1						1	Injection site reaction	FLU3~PFIZER\WYETH~~7+~IM L~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0111256	05/27/1998	PA	82.0	82		F	02/24/1998	pt recv vax & next day devel redness @ inj site;this event was dx as an allerg rxn;pt recovered;this is 1 of 2 residents from this facility to have an adverse exp p/pnu immune 23 lot#444070;				Y					Y	10/21/1997	10/22/1997	1		PVT	PVT	unk	NONE		~ ()~~~In patient	898105019L	1						1	Hypersensitivity; Injection site hypersensitivity; Hypersensitivity; Injection site hypersensitivity	FLU3~PFIZER\WYETH~4978208~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~444070~1~IM~LA~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~49782008~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~444070~1~IM~LA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0111257	05/27/1998	NC	25.0	25		F	12/16/1997	2 days p/vax pt devel an inj site rxn characterized by erythema & itching;pt was seen by MD treated w/DPH & application of ice & recovered;this is 1 of 3 pt of this facility to have an adverse exp p/flu vax lot#4978156				Y					Y	10/22/1997	10/24/1997	2		PVT	PVT	unk	NONE	allergic to PNC & erythromycin	~ ()~~~In patient	898106099L	1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~4978156~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0111258	05/27/1998	NC	40.0	40		F	12/16/1997	2 days p/vax pt devel an inj site rxn characterized by erythema & itching;pt also devel unspecified systemic sx which caused pt to miss 1 day of work;tx w/claritin & applications of ice & recovered;this is 1 of 3 pt from this facility w/rxn									Y	10/22/1997	10/24/1997	2		PVT	PVT	unk	NONE	hay fever, arthritis	~ ()~~~In patient	898106010L	1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~4978156~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0111259	05/27/1998	NY	47.0	47		F	11/26/1997	pt recv vax & 6hr p/vax pt devel an inj site rxn characterized by erythema, edema & pruritus;pt recovered;this is 1 of 9 pt from this facility to devel an inj site rxn p/flu vax lot# 4978139									Y	10/08/1997	10/08/1997	0		OTH	PVT	NONE	NONE		~ ()~~~In patient	898117008L	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4978139~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0111260	05/27/1998	NY	54.0	54		F	11/26/1997	1 day p/vax pt devel an inj site rxn characterized by erythema, induration & pruritus;pt recovered p/5 days;this is 1 of 9 pt from this facility to devel an inj site rxn p/flu vax lot# 4978139;									Y	10/08/1997	10/09/1997	1		OTH	PVT	Plendil	NONE		~ ()~~~In patient	898117009L	1						1	Injection site hypersensitivity; Injection site mass; Pruritus	FLU3~PFIZER\WYETH~4978139~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0111261	05/27/1998	NY	51.0	51		F	11/26/1997	pt recv vax & 5hr p/vax pt devel an inj site rxn characterized by erythema & pruritus;pt recovered p/5 days;this is 1 of 9 pt from this facility to devel an inj site rxn p/flu vax w/lot# 4978139;									Y	10/08/1997	10/08/1997	0		OTH	PVT	Synthroid	NONE	hypothroidsim	~ ()~~~In patient	898117010L	1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~4978139~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0111262	05/27/1998	NY	59.0	59		F	11/26/1997	pt recv vax & 5hr p/vax pt devel an inj site rxn characterized by erythema & pruritus;pt recovered p/5 days;this is 1 of 9 pt from this facility to devel an inj site rxn p/flu vax w/lot# 4978139;									Y	10/08/1997	10/08/1997	0		OTH	PVT	NONE	NONE	dust & springtime allergies	~ ()~~~In patient	898117011L	1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~4978139~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0111263	05/27/1998	NY	32.0	32		F	11/26/1997	approx 5 hr p/vax pt devel an inj site rxn characterized by erythema, induration & pruritus;pt recovered p/ 5 days;this is 1 of 9 pt from this facility to devel an inj site rxn p/flu vax w/lot# 4978139;									Y	10/08/1997	10/08/1997	0		OTH	PVT	NONE	NONE	allergic to PNC, gentamicin, Novacaine;	~ ()~~~In patient	898117012L	1						1	Injection site hypersensitivity; Injection site mass; Pruritus	FLU3~PFIZER\WYETH~4978139~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0111264	05/27/1998	NY	56.0	56		F	11/26/1997	3hr p/vax pt devel an inj site rxn characterized by 80mm by 90mm area of erythema, induration & pruritus;applied ice to the area & recovered p/5 days;this is 1 of 9 pt from this facility to devel an inj site rxn p/flu vax w/lot# 4978139;									Y	10/08/1997	10/08/1997	0		OTH	PVT	SYnthroid;Estrogen,Claritin D;	NONE	hypothyroidism, airbone allergies	~ ()~~~In patient	898117014L	1						1	Injection site hypersensitivity; Injection site mass; Pruritus	FLU3~PFIZER\WYETH~4978139~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0111265	05/27/1998	NY	45.0	45		F	11/26/1997	approx 5hr p/vax pt devel an inj site rxn characterized by an 80mm by 90mm area of erythema, induration & pruritus;pt applied ice to the area & recovered p/5 days;this is 1 of 9 pt from this facility to devel an inj site rxn p/flu vax;									Y	10/08/1997	10/08/1997	0		OTH	PVT	Flonase, Decongestants	NONE	hayfever, sinus arrythmia, allerg to PCN & fluoroquinolones;	~ ()~~~In patient	898117015L	1						1	Injection site hypersensitivity; Injection site mass; Pruritus	FLU3~PFIZER\WYETH~4978139~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0111266	05/27/1998	NY	33.0	33		F	11/26/1997	6hr p/vax pt devel an inj site rxn characterized by an 80mm by 90mm area of erythema, induration & pruritus;pt applied ice to the area & recovered p/5 days;this is 1 of 9 pt from this facility to devel an inj site rxn p/flu vax;									Y	10/08/1997	10/08/1997	0		OTH	PVT	Synthroid;	NONE	hypothyroidism	~ ()~~~In patient	898117016L	1						1	Injection site hypersensitivity; Injection site mass; Pruritus	FLU3~PFIZER\WYETH~4978139~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0111267	05/27/1998	OH	50.0			F	01/05/1998	20 days p/vax pt devel Bell's palsy;no further info was available @ the day of this report;				Y					U	10/01/1997	10/21/1997	20		OTH	OTH	unk	unk		~ ()~~~In patient	898120012L	1						1	Facial palsy	FLU3~PFIZER\WYETH~4978212~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0111277	05/27/1998	NJ				U	01/05/1998	pt recv vax & devel a fever which persisted as of 5JAN98;pt was hosp for unspecified reasons;					Y				U	12/15/1997				OTH	OTH	unk	unk	Hodgkin's lymphoma, COPD, asplenia, corticosteroid therapy from 1DEC97 to 9DEC97	~ ()~~~In patient	898006019L	1						1	Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0111278	05/27/1998	NJ	28.0			F	02/24/1998	pt recv vax & exp sensation of throat closing up;pt was seen in ER where dx of anaphylaxis was made;pt tx w/unspecified med & recovered;			Y	Y					Y					OTH	OTH	unk	unk		~ ()~~~In patient	898056007L	1						1	Anaphylactoid reaction; Laryngospasm	FLU3~CONNAUGHT LABORATORIES~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0111311	06/01/1998	MN	22.0	22		F	10/07/1997	pt w/flushing sl diaphoretic-sl itching of face;saw MD;435PM went back to work no longer flushed;									Y	10/07/1997	10/07/1997	0	445PM pulse 100, resp 24, BP 120/90;450PM pulse 84, resp 20, BP 110/70;455PM pulse 82, resp 24, BP 120/80;	OTH	PVT	Claratin D			~ ()~~~In patient		1						1	Hyperhidrosis; Pruritus; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81829~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0111312	06/01/1998	MN				M	10/29/1997	pt recv vax 29OCT97 & was sitting in chair w/jerking motions of head;eyes twitching;did not answer when spoken to;color pale;twitching lasted 20sec & pt became alert & responsive;BP 110/palp;sl upper extremity tremors;									Y	10/29/1997	10/29/1997	0	NONE	OTH	UNK	NONE		NONE	~ ()~~~In patient		1						1	Hypotension; Muscle twitching; Pallor; Stupor; Tremor	FLU3~CONNAUGHT LABORATORIES~7F81894~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0111313	06/01/1998	WI	14.0	14		F	10/21/1997	sl diff swallowing;BP 122/84, R16, P88;epi given 514PM;520PM P96, R18, BP 110/70;525PM 911 called hives on chest;530PM BP 130/74, P95, R20, no wheezing;still scratchy throat;				Y					Y	10/21/1997	10/21/1997	0		PVT	PVT		NONE	environmental allergies & amox	~ ()~~~In patient		1						1	Dysphagia; Hypertension; Hypoventilation; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~7F81829~2~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0111314	06/01/1998	MN	26.0	26		F	10/30/1997	pt c/o itching @ shot site 5min p/arm assessed;pt c/o feeling faint;pt assisted to another room to sit down;pt diaphoretic, pale, altered resp status, non comprehensive epi given;c/o nausea;shaky;no idea why in another room;									Y	10/30/1997	10/30/1997	0	1040AM P100, R 24, RP 120/84;1043AM P94, R24, BP 116/80;1048AM P80, Resp 20;	OTH	PVT	NONE	cold that is improved	Demulen make itchy;	~ ()~~~In patient		1						1	Confusional state; Dizziness; Hyperhidrosis; Hyperventilation; Pallor; Pruritus; Syncope; Tachycardia	FLU3~CONNAUGHT LABORATORIES~7F81894~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0111315	06/01/1998	MN	23.0	23		F	11/14/1997	pt recv vax & 2-3min later devel SOB, resp diff;HR 96, Resp 26 & audible wheezing w/inspiration;pt breathless, skin pale, cool & dry;BP 138/84;HR 108;BP 138/82, HR 106;pt instructed to be seen in ER or PMD for return of sx;									Y	11/14/1997	11/14/1997	0	205PM P96, R26, BP 138/84;210PM P110, R22, BP 138/84;212PM P108, R20, BP 138/84;215PM P106, R22, BP 138/82;	OTH	PVT	NONE	cold sx 1wk a/vax;	asthma;allergies PCN	~ ()~~~In patient		1						1	Asthma; Condition aggravated; Dyspnoea; Hypertension; Hyperventilation; Pallor; Tachycardia	FLU3~CONNAUGHT LABORATORIES~7F81894~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0111316	06/01/1998	MN	27.0	27		F	11/07/1997	pt recv vax & area on arm red & warm 3-4 circle;1PM BP 128/78 c/o tingling in face & neck side only;no SOB, no swelling in neck area;1:10 tingling better-improving left w/2nd employee;									Y	11/07/1997	11/07/1997	0		OTH	PVT				~ ()~~~In patient		1						1	Injection site hypersensitivity; Paraesthesia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81829~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0111349	06/01/1998	TX	84.0	84		F	05/08/1998	pt recv vax & devel pain;pain appeared to start @ the point of inj & travel up to collar bone area;MD found mass infect in a joint directly connected to clavicle bone;back pain;poss nerve damaged;test showed small peptic ulcer;			Y	Y	Y		Y		U	12/15/1997	12/15/1997	0		PVT	UNK	levothride, Relafen, Amitriptyine, procardia, excel, dyazide	chest pain & swelling in legs;	demerol;pain management back-sciatic nerve	NA~ ()~~~In patient	TX98065	1						1	Bone disorder; Condition aggravated; Infection; Injection site pain; Neck pain; Neuropathy; Peptic ulcer; Skin nodule	FLU3~PFIZER\WYETH~4978184~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0994E~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0111382	06/01/1998	TX	38.0	38		F	05/04/1998	p15,16, & 17APR devel fever;18APR devel painful enlarged lymph node behind ears, exp rt side;20APR went to MD & was given ATB tx;22APR h/a, burning to eyes & rash;went back to MD;									N	04/10/1998	04/15/1998	5	NONE	PUB	PUB	NONE	NONE	allergic to septra, sulfa & keflex	NA~ ()~~~In patient	TX98066	1						1	Eye pain; Headache; Lymphadenopathy; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~0906E~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0738E~UNK~A~~MEASLES + MUMPS + RUBELLA (MMR II)~1|TD~CONNAUGHT LABORATORIES~7F91700~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0111667	06/10/1998	KY	28.0	28		F	06/05/1998	pt became numb, spasms, sent to neurologist, dx multiple sclerosis;			Y	Y				Y	N	10/25/1997	12/20/1997	56	MRI X 2;	PUB	PVT				~ ()~~~In patient		1						1	Convulsion; Hypertonia; Multiple sclerosis; Muscle spasms; Paraesthesia; Speech disorder; Thinking abnormal	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Disabling	Influenza
0111878	06/15/1998	LA	62.0	62		F		pt c/o lt arm pain 2-3 day p/vax;has been to several different MD since then for same complaint;now under going physical therapy;states lt arm hurts anytime raises arm;pt feels r/t flu shot;states no MD has said flu vax caused arm problems;				Y					N	10/13/1997	10/15/1997	2	MRI, X-rays;	PUB	PUB	sulap;lasix;Amaryl	NONE	hx of kidney problems;	~ ()~~~In patient	LA980604	1						1	Hypokinesia; Pain	FLU3~MEDEVA PHARMA, LTD.~3257FA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~CONNAUGHT LABORATORIES~6L81392~UNK~IM A~~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0111947	06/17/1998	TX	54.0	54		M		24NOV97 devel pain & weakness rt leg also included rt shoulder & neck;26NOV97 pt seen by MD who sent pt to ER-adm to hosp;2DEC97 dx GBS miller-fisher variance;8DEC97 double vision & inc reflexes;weakness arm & eyelid;dx bells palsy 16JUL97					Y	14			Y	10/14/1997	11/24/1997	41		OTH	PUB		NONE	Bells Palsey 16JUL97 lasted 3mo;	NA~ ()~~~In patient	SA98005	1						1	Diplopia; Facial palsy; Guillain-Barre syndrome; Hyperreflexia; Myasthenic syndrome; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0111958	06/18/1998	NC	36.0	36		F	06/16/1998	pt recv vax & devel chronic fatigue immune dysfunction synd;pt out of work x 5yr;pt was working full time a/the vax;  3/6/08 Reviewed outpatient clinic records of 8/2006-1/2008.  Clinic states only records available.  These records indicated chronic fatigue syndrome initially diagnosed 11/1991 s/p flu shot.  Moved to MH group home 4/2007.  Several ER visits for UTI & asthma. PMH: atopic dermatitis/ateatotic dermatitis; rosacea; skin tags; depression; chronic dysthymia disorder w/insomnia & anxiety; alcohol abuse; migraines; asthma; genital herpes; seasonal allergies; GERD; IBS; impaired fasting glucose;  family hx of diabetes; umbilical hernia repair w/mesh; obesity; uterine fibroids; pre-glaucoma;  ALLERGIES: PCN, sulfa, vaccines Per 60 day follow up: Residual symptoms are chronic fatigue, cognitive function problems, calculation difficulties, memory disturbance, spatial disorientation, frequently saying the wrong word, depression, insomnia, migrane, muscular weakness, severe allergies & asthma, joint pain, IBS, multiple sensitivities to chemicals, meds & food, recurring yeast bacterial infections. It is required by law that a doctor report vaccine reactions, did they? I have been son sick since Nov. 1991 that I have not even been able to get help and no money to get it. I have to live off of $356.00 a month. Are they going to help me.  Follow-up: I do not have the information you requested. I have not been able to work since the flu shot in November 91. (I think it was the day before Thanksgiving I can't think of anything more cruel than to not help someone after they have a reaction. I was to sick to do anything but go to doctors. 02/05/2010 Follow up: Fatigue, cognitive function problems and calculation difficultiesm memory problems, depression, anxiety, insomnia, can't work anymore, myalgic encephalomyelitis (chronic).			Y	Y				Y	N	11/01/1991	11/27/1991	26		PVT	PVT	Trazodone	NONE; Depression; Anxiety	Depression			1						1	Activities of daily living impaired; Arthralgia; Cognitive disorder; Disorientation; Food allergy; Fungal infection; Immune system disorder; Memory impairment; Multiple chemical sensitivity; Muscular weakness; Speech disorder; Thinking abnormal	FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Disabling	Influenza
0112032	06/22/1998	WV	48.0	48		F	06/11/1998	lt arm pain-elbow to shoulder heat, ice, exercise, pain is still occurring daily									N	10/05/1997	10/05/1997	0	NONE	OTH	PUB	ERT	NONE	NONE	~ ()~~~In patient		1						1	Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0112054	06/23/1998	SC	20.0	20		M	05/22/1998	pt recv vax 19MAY98 & presented to treatment room on 20MAY 1PM w/ c/o swelling on rt upper arm-large amount of edema present w/redness;states redness began posterior aspect of arm where recv meningococcal vax;				Y					Y	05/19/1998	05/20/1998	1		MIL	MIL	PPD by Parke Davis lot# 01418P given 19MAy98;	NONE	NKDA	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~7J81910~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~CONNAUGHT LABORATORIES~0908980~1~SC A~~MENINGOCOCCAL (MENOMUNE)~1|MMR~MERCK & CO. INC.~1611E~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TD~CONNAUGHT LABORATORIES~449579~1~IM A~~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0112065	06/23/1998	SC	19.0	19		F	04/04/1998	sudden onset shaking-pt placed supine w/leg elevated-lung sounds CTA;responsive but dazed;pulse ox 99% during entire time;began to hear faint wheezing;given epi;				Y					Y	03/30/1998	03/30/1998	0		MIL	MIL	NONE	NONE	NKDA no defects identified	~ ()~~~In patient		1						1	Asthma; Stupor; Tremor	FLU3~CONNAUGHT LABORATORIES~7J81910~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1611E~1~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1|TD~LEDERLE LABORATORIES~449579~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0112068	06/23/1998	NJ	27.0	27		F	06/12/1998	hives all over face & neck, w/swelling & itchiness;eyes swollen shut for short period of time 1-2hr, then swelling went down but remained for several days;									Y	10/22/1997	10/24/1997	2	NONE	OTH	PUB	birth control pills	cold	NONE	~ ()~~~In patient		1						1	Face oedema; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0112252	07/01/1998	NC	35.0	35		F	06/09/1998	myelitis onset approx 1wk p/vax;cont paresthesia lower extremities, hands, weakness of lower extremities;tx w/IV steroids DEC97 & JUN98;to start Betainter-feron for poss MS JUN98;				Y	Y	1			N	11/10/1997	11/17/1997	7	MRI head negative;spine negative;LP negative;evoked potentials, visual, brain stem & extremities;	PVT	PVT	birth control pill	NONE	allergy to cephalosporin	~ ()~~~In patient		1						1	Multiple sclerosis; Myasthenic syndrome; Myelitis; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~~4~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0112334	07/06/1998	TX	44.0	44		M	06/29/1998	pt recv vax & over next 4wk pt had a progressive illness of flu like sx & gen malaise;pt hosp 30NOV96 & exp disseminated encephalomyelitis, HTN, acute renal insufficiency, lt hemiplegia & depression;urine incontinent;					Y	25			N	10/17/1996				UNK	UNK			optic neuritis, papilledema, inc intracranial pressure & elevated immunoglobulins in spinal fluid;lt sided weakness;	~ ()~~~In patient	U1998003112	1						1	Depression; Encephalitis; Hemiplegia; Hypertension; Influenza; Myelitis; Renal impairment; Urinary incontinence	FLU3~CONNAUGHT LABORATORIES~6F71247~7+~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0112363	07/06/1998	NY	40.0	39		F	04/02/1998	on 1st day, arm started feeling heavy;by 2nd day pain in arm was excruciating;moved up & down arm & was unable to sleep @ noc for a couple of months;arms would get stiff & lock up @ noc;mostly gets sore when weather moist;not full ROM;									N	10/15/1997	10/16/1997	1	NONE	PVT	PVT		NONE	NONE	~ ()~~~In patient	NY98012	1						1	Hypertonia; Hypokinesia; Insomnia; Myasthenic syndrome; Pain; Asthenia; Hypokinesia; Insomnia; Myasthenic syndrome; Pain; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E3327GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~E33276A~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0112365	07/06/1998	NY	40.0	40		F	03/24/1998	soreness followed by inc discomfort over first few days w/persistence over months;dx brachial plexitis;									N	10/15/1997	10/17/1997	2	EMG studies;	PVT	PVT				~ ()~~~In patient	NY98011	1						1	Myalgia; Neuropathy; Pain	FLU3~MEDEVA PHARMA, LTD.~E3327GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0092406	07/13/1998	MD	37.0	37		M	06/15/1998	1 days p/vax pt devel pain, swelling, redness, warmth, purple discoloration & skin eruptions @ the site of pnu-immune 23;also devel pain rt elbow, hand, hip & knee, myalgia, extreme tiredness,swelling under the arm, weakness;									Y	10/23/1996	10/24/1996	1	NONE	OTH	OTH			allergies hayfever, all pollen, wheat, environment dust & mold	~ ()~~~In patient	MPI971084	1						3	Anorexia; Arthralgia; Asthenia; Injection site hypersensitivity; Injection site oedema; Lymphadenopathy; Pyrexia; Vasodilatation; Asthenia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Lymphadenopathy; Myalgia; Myasthenic syndrome; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E2986FA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~PFIZER\WYETH~390966~1~IM~RA~PNEUMO (PNU-IMUNE)~2|FLU3~MEDEVA PHARMA, LTD.~E2986FA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~3|PPV~PFIZER\WYETH~390966~UNK~IM~~PNEUMO (PNU-IMUNE)~3	USA		Influenza
0104709	07/13/1998	FL	49.0	49		M	06/12/1998	pt recv vax & exp lots of swelling, muscle & tissue pain for 5 days then fever, chills & pain all over & in hair;MD described as miserable & had lot 5 lb;gen malaise x 2 days;									Y	10/17/1997	10/17/1997	0	NONE	OTH	OTH			NONE	~ ()~~~In patient	MPI97819C	1						2	Chills; Injection site oedema; Injection site pain; Malaise; Myalgia; Pain; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E3367HC~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0105617	07/13/1998	NY	57.0	57		F	06/15/1998	pt recv vax & exp pain in lt arm;pt was advised to see MD if pain cont which it did;MD felt it was coincidental & is more likely to be a pinched nerve;pt taking physical therapy & x-rays have been requested;									N	10/06/1997	10/06/1997	0	NONE	OTH	OTH	Accupril;Furosemide;Pravacholor;Premarin		HTN;hyperchoesterolaemia;hysterectomy;	~ ()~~~In patient	MPI971083	1						2	Neuropathy; Pain	FLU3~MEDEVA PHARMA, LTD.~E3277MB~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0112363	07/13/1998	NY	40.0	39		F	06/11/1998	pt recv vax & exp limited range of movement, weakness, discomfort & tingling in arm p/vax;pt devel heaviness in arm on 1st days & started to exp severe pain on the 2nd day w/any movement of lt arm;unable to sleep d/t pain @ least 2mo;									N	10/15/1997	10/16/1997	1	NONE	OTH	OTH			NONE	~ ()~~~In patient	MPI971036B	1						2	Hypertonia; Hypokinesia; Insomnia; Myasthenic syndrome; Pain; Asthenia; Hypokinesia; Insomnia; Myasthenic syndrome; Pain; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E3327GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~E33276A~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0112461	07/13/1998	MO	56.0	56		F	06/11/1998	w/in a wk of vax pt slowly deteriorated & got bronchitis;lungs filled w/fluid & was adm to hosp p/collapsing;pt put in ICU on ventilator & then a respirator;dx pneumonia;pulmonary specialist felt problem not r/t vax;					Y				U	10/17/1997	10/21/1997	4	blood & sputum cult negative;	OTH	OTH			25NOV97 mastectomy status hx of bilat mastectomy a few yr ago;adult resp distress dynd (ARDS);hypogammaglobulinemia;	~ ()~~~In patient	MPI97972	1						1	Bronchitis; Hypoxia; Infection; Lung disorder; Pneumonia	FLU3~MEDEVA PHARMA, LTD.~E3287GG~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0112464	07/13/1998	IN				U	06/23/1998	MD reported having multiple pt w/adverse rxn p/flu vax;one pt had been hosp & another who is very sick;					Y				U	09/01/1997	09/01/1997	0	NONE	OTH	OTH			NONE	~ ()~~~In patient	MPI97730	1						1	Malaise	FLU3~MEDEVA PHARMA, LTD.~E33179A~2~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0112501	07/13/1998	FL	61.0	61		F	06/10/1998	pt reports exp lt upper arm muscle deterioration w/pain (inc w/movement), itching & a red streak around the inj site p/vax;w/in a month pt noted itching, burning, redness, 2 red streaks on arm;arm sink in place @ inj site;									U	10/30/1996	10/30/1996	0	NONE	OTH	OTH	Albuterol;Atrovent;Theo-Dur		hx of cardiac arrest status;pneumonia, organism unspecified status;	pt exp sl redness, small red circel @ 61 w/flu vax;~ ()~~~In patient	MPI97732	1						1	Hypokinesia; Injection site atrophy; Injection site hypersensitivity; Myalgia; Myasthenic syndrome; Pain; Pruritus; Skin striae	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112507	07/13/1998	MI				U	06/11/1998	several pt recv vax & inj site swelling & soreness;some of the pt have required ATB tx however not all the pt have returned to the MD office;									U	09/01/1997	09/01/1997	0	NONE	OTH	OTH			NONE	~ ()~~~In patient	MPI97724	1						1	Injection site oedema; Injection site pain	FLU3~MEDEVA PHARMA, LTD.~E357GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112509	07/13/1998	MI	37.0			F	06/11/1998	pt recv vax & noticed red bumps around inj site;2 days p/vax reported a rash starting on the palms of hands & then on foot & chin;called MD who prescribed medrol & DPH;p/2 more day reported hard time breathing & nape of neck swollen;to ER;				Y					Y	09/11/1997	09/12/1997	1	NONE	OTH	OTH	Zyban/Bupropion HCL		allergies pt has allergies to unspecified environmental factors	~ ()~~~In patient	MPI97742	1						1	Dyspnoea; Injection site hypersensitivity; Oedema; Rash	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0112516	07/13/1998	IL				F	06/12/1998	pt recv vax & c/o hands tingled p/inj;the reporter stated there was no active disease present @ the time & recommended pt see MD;									U	10/16/1997	10/16/1997	0	NONE	OTH	OTH			16OCT97 lupus erythematosus	~ ()~~~In patient	MPI97782	1						1	Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112517	07/13/1998	FL	85.0	85		F	06/11/1998	pt recv vax & exp inj site rxn consisting of redness & swelling extending down arm to elbow regions w/in 24hr of vax;pt has an allergy to PCN;rxn described as upper arm 2/3 red, warm, indurated;									U	10/10/1997	10/11/1997	1	NONE	OTH	OTH	Allopurino;Dyazide;Estinyl;Pred;Tenormin		allergy PCN	~ ()~~~In patient	MPI97783A	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E3267GB~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112518	07/13/1998	FL	53.0	53		F	06/12/1998	pt recv vax & exp an inj site rxn consisting of redness & swelling extending down arm to elbow regions w/in 2 days of vax;it was reported that pt has an allergy to PCN;sx resolved w/in 3 days;pt reported sx 24hr post vax w/duration of 72hr;									Y	10/08/1997	10/11/1997	3	NONE	OTH	OTH	premarin/conjugated		allery PCN;13OCT97 hysterectomy;	~ ()~~~In patient	MPI97783B	1						1	Injection site hypersensitivity; Injection site oedema; Oedema peripheral	FLU3~MEDEVA PHARMA, LTD.~E267GB~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112520	07/13/1998	VA	59.0	59		F	06/11/1998	pt recv vax & exp inj site soreness w/bruising & itchiness ;pt also c/o of area being sensitive to touch;MD felt site not infected;pt has recv flu vax in past w/no rxn;									N	10/15/1997	10/20/1997	5	NONE	OTH	OTH			NONE	~ ()~~~In patient	MPI97785	1						1	Ecchymosis; Injection site pain; Pruritus	FLU3~MEDEVA PHARMA, LTD.~E20017HB~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112521	07/13/1998	PA	47.0			F	06/11/1998	pt recv vax & began w/itching sensation all over body & a strange h/a p/24hr;the itching cont @ time of report 5 days later;pt referred to her MD;prev flu vax uneventful;no allergy to eggs;				Y					U	10/14/1997	10/15/1997	1	NONE	OTH	OTH			NONE	~ ()~~~In patient	MPI97786	1						1	Headache; Pruritus	FLU3~MEDEVA PHARMA, LTD.~E3367HB~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0112524	07/13/1998	KY	48.0	48		F	06/12/1998	pt recv vax & exp urticaria w/in 6hr of vax;pt had a sl elevated temp but in good hlth;rash described as raised areas on arms & legs-no rash or swelling @ inj site;itching for 3-4wk;									Y	10/17/1997	10/17/1997	0	NONE	OTH	OTH			allergies PCN;carcinoma in situ breasts status;tx w/chemotherpay;herpes zoster reported as shingles;	~ ()~~~In patient	MPI97790	1						1	Pruritus; Pyrexia; Rash maculo-papular; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E3367HC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112525	07/13/1998	PA	48.0	48		F	06/11/1998	pt recv vax & 6hr later reported was very sick-sx of chills, fever, h/a & runny nose;on f/u myalgias, rhinorrhea, sl productive cough & low grade fever 101;									Y	10/18/1997	10/18/1997	0	NONE	OTH	OTH			allergy preservative, sulfa->nausea;MS ongoing;	~ ()~~~In patient	MPI97797	1						1	Chills; Cough; Headache; Malaise; Myalgia; Pyrexia; Rhinitis	FLU3~MEDEVA PHARMA, LTD.~E20037KB~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112527	07/13/1998	NC	48.0	48		F	06/11/1998	pt recv vax & exp an inj site rxn described as a 6x3 area w/redness, swelling & warmth p/vax;rxn described as very hot & dizzy;approx 3min p/vax;next day arm was red & swollen & hot to touch;									U	10/13/1997	10/13/1997	0	NONE	OTH	OTH	Premarin		HTN;disorders of iron metabolism status;hemachromatosis	~ ()~~~In patient	MPI97800A	1						1	Dizziness; Injection site hypersensitivity; Injection site oedema; Pyrexia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~EE20017HC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112528	07/13/1998	NC	35.0			F	06/11/1998	1 of 4 pt  exp an inj site rxn described as hot, red & swollen approx 3x3 in size day p/vax;sx resolved 3-4 days later;									Y	10/13/1997	10/13/1997	0	NONE	OTH	OTH			allergy ASA, codeine	~ ()~~~In patient	MPI97900B	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20017HC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112529	07/13/1998	NC	41.0	41		F	06/11/1998	1 of 4 pt exp an inj site rxn described as a 3x3 area w/redness, swelling & hot to touch the day p/vax;sx resolved p/3 days;MD described swelling, redness, warm to touch, hardened area for several days;									Y	10/13/1997	10/13/1997	0	NONE	OTH	OTH			allergies PCN, EES, sulfa, tetracycline, lincocine, tape	~ ()~~~In patient	MPI97800C	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20017HC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112530	07/13/1998	NC	55.0			F	06/11/1998	1 of 4 pt exp inj site rxn on same day as vax;rxn had appearance of acute cellulitis hot red, swollen 6x4 area p/vax; sx resolved w/in 1wk;									Y	10/13/1997	10/13/1997	0	NONE	OTH	OTH			NONE	~ ()~~~In patient	MPI97800D	1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~E20017HC~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0112534	07/13/1998	MD	36.0			F	06/11/1998	pt recv vax who exp bruising (1.5cm x 2cm) @ the inj site two days p/vax;									U	10/25/1997	10/27/1997	2	NONE	OTH	OTH			NONE	~ ()~~~In patient	MPI97810	1						1	Ecchymosis	FLU3~MEDEVA PHARMA, LTD.~E3327GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112538	07/13/1998	FL	75.0	75		F	06/12/1998	pt recv vax & exp inj site swelling (10 diameter), tachycardia, resp distress, fever of 103F, chills & shoulder pain for 7 days;pt also exp gen malaise;									Y	10/17/1997	10/17/1997	0	NONE	OTH	OTH	Relafen;Zantac;Zovirax;		unspecified arthritis;gastritis;herpes simplex;	~ ()~~~In patient	MPI97819A	1						1	Chills; Injection site oedema; Malaise; Pain; Pyrexia; Respiratory disorder; Tachycardia	FLU3~MEDEVA PHARMA, LTD.~E3367HC~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0112539	07/13/1998	FL				M	06/22/1998	A number of pt got sick p/vax; had sx of swollen inj site 910 in diameter), tachycardia, resp distress, fever of 103, chills & shoulder pain for 7 days;									U	10/22/1997	10/22/1997	0	NONE	OTH	OTH			NONE	~ ()~~~In patient	MPI97819B	1						1	Chills; Injection site oedema; Malaise; Pain; Pyrexia; Respiratory disorder; Tachycardia	FLU3~MEDEVA PHARMA, LTD.~E3367HC~2~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112542	07/13/1998	MA	19.0			M	06/15/1998	pt inadvertently recv two doses of vax 31OCT97 & 3NOV97;pt is unable to communicate & pt could not be certain that had had two doses; Follow up information received July 17, 1998 states vaccinee was reported to have received one dose on October 25 and a second on November 3. There was no adverse side effects due to administration of two flu vaccines. Follow up information received 3/02. A mother reported that her 7 year old child received 4th dose of Hib-Titer on Dec 4, 1997 adn within hours, developed a 6-inch hive at the injection site. The patient reportedly subsequently developed hives which migrated over entire body. The patient was taken to the emergency room. Manufacturer's Comment: The lot number was reported as M330PD, however, this is not a valid Lederle lot number. Follow-up information received from the physician on Oct 23, 2001 provided the patient's birth weight of 8 pounds, 5 ounces, indicated that the patient received no other vaccines within four weeks of Hib-Titer administration, and the patient recovered.				Y					Y	10/25/1997			NONE	OTH	OTH		Disabled status: ongoing. unable to communicate			EML97826	1						1	Inappropriate schedule of drug administration; Injection site urticaria; Unevaluable event; Urticaria	FLU3~MEDEVA PHARMA, LTD.~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0112543	07/13/1998	GA	77.0	77		F	06/11/1998	pt recv vax & had sx of vomiting, nausea, aching in joints, sl inc in temp 99.7, felt extremely weak 1 day p/vax;									U	10/24/1997	10/25/1997	1	CBC 14.3;	OTH	OTH	Acetazolamide;Bentyl;Eldertonic;Premarin;		COPD ongoing;irritable bowel synd;chronic organic brain synd;degenerative joint disease;impaired gastrointestinal tract;subarachnoid haemorrage;	~ ()~~~In patient	MPI97829A	1						1	Arthralgia; Asthenia; Nausea; Pyrexia; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E3277GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112544	07/13/1998	GA	66.0	66		F	06/12/1998	pt recv vax 21OCT97 & exp sx of n/v, raised temp 3 days p/vax;tx w/phenergan & sx resolved;									Y	10/21/1997	10/24/1997	3	NONE	OTH	OTH	Caltrate/calcium carbonate;Celestone Betamethasone;Calritin;Premarin;		thyroid dysfunction	~ ()~~~In patient	MPI97829B	1						1	Pyrexia; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E3277GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112545	07/13/1998	GA	52.0	52		F	06/11/1998	pt recv vax 20OCT97 & exp inc temp 100, n/v, diarrhea, chills, chest pain & severe h/a x 2 days;									Y	10/20/1997	10/21/1997	1	NONE	UNK	UNK	ASA;Vancenase;			~ ()~~~In patient	MPI97829C	1						1	Chest pain; Chills; Diarrhoea; Headache; Pyrexia; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E3277GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112546	07/13/1998	GA	41.0	40		M	06/15/1998	pt recv vax 20OCT97 & devel wheezing, cough, vomiting & an inc temp to 99 4 days p/vax; tx w/med;									Y	10/20/1997	10/24/1997	4	NONE	OTH	OTH	Serentil;Zantac		Mental retardation;Gastroesphegal reflux disease;	~ ()~~~In patient	MPI97829D	1						1	Asthma; Cough; Pyrexia; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E277GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112547	07/13/1998	GA	41.0	41		M	06/11/1998	pt recv vax & had sx of rhinorrhea, stuffy nose, green productive cough, facial pressure & wheezing in the chest 1 day p/vax; tx w/med;									Y	10/23/1997	10/24/1997	1	NONE	OTH	OTH			knee surgery;hx of colon cancer in parents	~ ()~~~In patient	MPI97829E	1						1	Asthma; Cough; Rhinitis	FLU3~MEDEVA PHARMA, LTD.~E3277GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112560	07/13/1998	AR				F	06/11/1998	pt recv vax & described sx of eye itch, eye worsening & aching all over, joints are aching, can't put weight on feet the lt side of body but ankles are very sore 2 days p/vax;				Y					U	10/13/1997	10/14/1997	1	NONE	OTH	OTH			NONE	~ ()~~~In patient	MPI97907	1						1	Arthralgia; Eye disorder; Gait disturbance; Hypokinesia; Myalgia; Pain; Pruritus	FLU3~MEDEVA PHARMA, LTD.~E20017HC~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0112561	07/13/1998		16.0	16		F	06/11/1998	mom reports child recv 2nd dose of vax w/in a week of the first;the only rxn noted was a sore arm (not specified which arm);mom reported exp flu like sx p/prev flu vax;prev hx of fatigue & mild chest pain;									U	10/31/1997			NONE	OTH	OTH	Minocin;Vitamin B12		debility & undue fatigue	~ ()~~~In patient	MPI97909	1						1	Asthenia; Chest pain; Influenza; Myalgia	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112580	07/13/1998	NY	43.0			F	06/15/1998	pt recv vax & exp limited range of movement, weakness, discomfort & tingling in arm p/vax;pt exp pain in lt upper extremity starting 1 day p/vax;pt gradually worsened & became sufficiently severe to limit ROM & awaken pt @ noc;									U	10/15/1997	10/16/1997	1	NONE	OTH	OTH			allergy PCN	~ ()~~~In patient	MPI971036C	1						1	Hypokinesia; Insomnia; Myasthenic syndrome; Pain	FLU3~MEDEVA PHARMA, LTD.~E33276A~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112581	07/13/1998	NY	40.0			F	06/15/1998	pt recv vax & exp limited rang of movement, weakness, discomfort & tingling in arm p/vax;pt c/sx about 1mo p/vax;duration of these sx not reported;pt sought hosp attention but not admitted;pt exp pain;									U	10/15/1997	10/15/1997	0	NONE	OTH	OTH			NONE	~ ()~~~In patient	MPI971036D	1						1	Myasthenic syndrome; Pain; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E33276A~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112582	07/13/1998	NY				F	06/11/1998	pt recv vax & 2 days later devel pain in lt elbow & the next day devel a 2x2 swelling in lt elbow radiating to axilla;consulted MD next day & prescribed ATB for ?abscess;									U	10/17/1997	10/20/1997	3	NONE	OTH	OTH			rheumatoid arthritis status ongoing	~ ()~~~In patient	MPI971037	1						1	Abscess; Oedema peripheral; Pain	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112583	07/13/1998	FL				M	06/11/1998	pt recv vax & reports dull sharp pain @ inj site & rt eye pulsation;time to onset & duration sx not reported;pt was reported to have had blood test & EKG but findings not stated;pt taking zantac;									U	10/21/1997			NONE	OTH	OTH	Zantac		NONE	~ ()~~~In patient	MPI971071	1						1	Eye disorder; Injection site pain	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112584	07/13/1998	MD	32.0			F	06/11/1998	pt recv vax & 4hr p/vax pt became nauseated, then vomited;intermittent vomiting cont for the following 2 days;pt seen in ER on the evening of the 2nd day p/vax;pt had some trouble breathing;									U	10/31/1997	10/31/1997	0	NONE	OTH	OTH			NONE	~ ()~~~In patient	MPI971072	1						1	Dyspnoea; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E3287GG~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112585	07/13/1998	KS				U	06/12/1998	pt recv vax & became disorientated & shaky;									U	10/01/1997	11/01/1997	31	NONE	OTH	OTH			NONE	~ ()~~~In patient	MPI971073	1						1	Confusional state; Tremor	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARCEL~MERCK & CO. INC.~~UNK~~~VARICELLA (VARIVAX)~1	USA		Influenza
0112586	07/13/1998	CT	69.0	69		F	06/12/1998	pt was given 1ml instead of 0.5ml of vax;pt devel 5-6cm induration & soreness @ the inj site;the local rxn lasted about 2 days & pt now fine;									Y	10/20/1997	10/20/1997	0	NONE	OTH	OTH			NONE	~ ()~~~In patient	MPI971074	1						1	Injection site mass; Injection site pain	FLU3~MEDEVA PHARMA, LTD.~~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112589	07/13/1998	NJ	68.0	68		F	06/11/1998	pt recv vax & 2 days p/vax exp gen aching type pain in both knees, going down leg to feet;									U	09/29/1997	10/01/1997	2	NONE	OTH	OTH			NONE		MPI971105	1						1	Arthralgia; Myalgia	FLU3~MEDEVA PHARMA, LTD.~E3327GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~SMITHKLINE BEECHAM~53986~UNK~IM~~HEP A (HAVRIX)~1|OPV~PFIZER\WYETH~445626~UNK~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~1|TD~CONNAUGHT LABORATORIES~7E91672~UNK~IM~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0112592	07/13/1998	GA	74.0	74		F	06/15/1998	pt recv vax & had sx of n/v, flu like sx, inc temp to 101 w/onset 2 days p/vax;had real bad cough, sore throat, been sick since vax;									Y	11/06/1997	11/06/1997	0	NONE	OTH	OTH			HTN;Hypercholesterolaemia;irritable bowel synd;melanoma-malignant melonoma (site unspecified);muscle contraction, h/a;	~ ()~~~In patient	MPI971120	1						1	Cough; Influenza; Malaise; Pharyngitis; Pyrexia; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E3277GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112593	07/13/1998	GA	67.0	67		F	06/11/1998	pt recv vax & exp coughing, nausea, aching joints, congestion & aching all over w/inset 2 days p/vax;									N	10/09/1997	10/11/1997	2	NONE	OTH	OTH			sinusitis;Diabetes unspecified;other diseases of lung-pulmonary disease;cardiac arrhythmia bradycardia;	~ ()~~~In patient	MPI971121	1						1	Arthralgia; Bronchitis; Cough; Myalgia; Nausea; Pharyngitis; Rhinitis	FLU3~MEDEVA PHARMA, LTD.~E32779A~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112597	07/13/1998	NY	67.0	67		F	06/15/1998	pt recv vax & exp severe pain in arm (not stated which arm);MD said would go away in a few days;pain was described as stomach wrenching & cont;had limited ROM;about 1mo later still exp pain & returned to MD;									U	11/01/1997	11/01/1997	0	x-ray 1DEC97;	OTH	OTH	hormone pills;		NONE	~ ()~~~In patient	MPI98089	1						1	Hypokinesia; Pain	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0112598	07/13/1998	NY	48.0	48		F	06/15/1998	23DEC97 pt exp runny nose & next day felt sick & had little energy, went to work late & left early;by 1JAN98 was bedridden & did not get u p for 4 days;had bad sinuses, coughing, bronchitis-like feeling, SOB, no voice;anemia;pleural effusio									U	12/19/1997	12/23/1997	4	CXR-unk pleural effusion;full blood count;RSV test negative;	OTH	OTH	Hormone therapy			~ ()~~~In patient	MPI98090	1						1	Anaemia; Asthenia; Bronchitis; Cough; Dyspnoea; Hypokinesia; Pleural effusion; Speech disorder	FLU3~MEDEVA PHARMA, LTD.~E3277GB~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0112600	07/13/1998	CT	75.0	75		M	06/11/1998	pt recv vax 17OCT97 & 2wk later exp sudden onset of severe (debilitating) muscle aches & pains in hands, knees & legs;there was no rxn @ the inj site @ the time of inj;no dx has been made;x-ray has shown mild osteoarthritis;				Y					N	10/17/1997	11/01/1997	15	x-ray unk;CXR lungs negative;x-ray joints (NOS) mild osteoarthritis;ESR;BUN, creatinine;anti-nuclear antibody	OTH	OTH	Norvasc;Quinapril;Vasotec		HTN;thalassaemias status ongoing has accompanying iron deficiency & low red blood cell count;	~ ()~~~In patient	MPI98322	1						1	Arthralgia; Arthritis; Myalgia; Pain	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0112663	07/16/1998	UT	77.0	77		M	11/21/1997	necrotic area on rt arm in area where flu vax had been given;										10/30/1997	10/30/1997	0		UNK	UNK	Docusate NA;Cyanocobalamin;Meclizine HCL;Amantadine;Carbidopa; 50 & Carbidopa 25;Lactulose;Naproxen;Cisparide;Sertraline;			~ ()~~~In patient		1						1	Injection site necrosis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0112667	07/16/1998	UT	78.0			M	10/10/1997	n/v, erythema, rash, induration;										10/03/1997	10/09/1997	6		UNK	UNK	APAP;Digoxin;Amiodron;			~ ()~~~In patient		1						1	Nausea; Rash; Skin nodule; Vasodilatation; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0108666	07/21/1998	MT	50.0	50		M	07/15/1998	numbness, paralysis, vasculitis, neuropathy, paresthesia, hypokinesia;pt saw neurologist & Internist;pt had CAT scans, MRI, nerve biopsy & med;					Y	1		Y	N	10/03/1997	10/06/1997	3	no abnormalities found in any tests;	PUB	OTH	NONE	NONE	allergies to pollen, grass, dust	NONE~ ()~~~In patient		1						3	Hypokinesia; Neuropathy; Paraesthesia; Paralysis; Vasculitis; Hypokinesia; Hypotonia; Myasthenic syndrome; Neuropathy; Paraesthesia; Hypokinesia; Neuropathy; Paraesthesia; Paralysis; Vasculitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~3	USA	Hospitalisation,Disabling	Influenza
0112885	07/28/1998	TN	68.0			M		pt recv vax & 20-30min p/vax pt had syncopal episode called 911 when came to & found by amb service to be in ventricular tachycardia;					Y		Y				10/01/1997		K+ OK no CK sump	UNK	UNK	Theoodur & inhalers;ace inhibitor		s/p MI 1989	~ ()~~~In patient		1						1	Syncope; Ventricular tachycardia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0112982	07/31/1998	CA	71.0			M	01/05/1998	Pt recv vax on 10/96 shortly after became ill.  Dx giant cell arteritis.  Tx with pred.  Outcome fairly good.				Y					U	10/01/1996	10/01/1996	0		OTH	OTH	unk	UNK		~ ()~~~In patient	898120010L	1						1	Arteritis; Malaise	FLU3~PFIZER\WYETH~4968143~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~4331404~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0091694	08/03/1998	CA	53.0	53		F	07/30/1998	Information has been received from a physician concerning a 53-year-old menopausal female with migraines and hypertension who on 19OCT95 was vaccinated with one dose of pneumococcal vaccine -23 IM in the right deltoid. Concomitant vaccination included a second dose of influenza vaccine administered IM in the left deltoid. Other concomitant therapy included PREMARIN and spironolactone. Within hours of the vaccination, the patient developed local swelling of the right arm. Susequently, the patient experienced chills, sweats, fever, elevated sedimentation rate to greater than 125 and ologoarthralgias. The patient was treated with prednisone with partial response. At the time of the report, the patient's symptoms presisted. No further details were provided.									N	10/19/1995	10/19/1995	0	erythrocyte sedimentation >125 elevated;	PVT	PVT	Premarin; spironolactone		HTN, menopause;migraine;		WAES97062563	1						2	Arthralgia; Chills; Hyperhidrosis; Hypertension; Injection site oedema; Menopause; Migraine; Pyrexia; Red blood cell sedimentation rate increased	FLU3~PFIZER\WYETH~4958120~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~MERCK & CO. INC.~1075B~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0103905	08/03/1998	FL	74.0	74		F	07/30/1998	pt recv vax 8SEP97 & pt reported inj site warmth, redness & tenderness, arm swelling;pt was evaluated @ the office & tx w/med;9SEP97 pt reported a little soreness but no swelling;				Y					Y	09/08/1997	09/08/1997	0		PVT	PVT	Claritin;Climara;			~ ()~~~In patient	WAES97090838	1						2	Injection site hypersensitivity; Injection site pain; Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0846D~1~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0104303	08/03/1998	MS	63.0	63		F	07/30/1998	pt recv vax 23OCT97 & that same evening pt exp restlessness, arm was sore w/red circles 3 to 4 inches in diameter, two large, red, raised, hard areas;24OCT97 pt felt badly & took a bed rest;also exp chills & fever 102;									N	10/23/1997	10/23/1997	0		UNK	UNK	Limbitrol tablets;librax capsules;norpramin;estrogenic preparations;desyrel;halcion		sulfa allergy;tetanus toxoid allergy	No relevant data;~ ()~~~In patient	WAES97110353	1						2	Agitation; Chills; Hypokinesia; Malaise; Myalgia; Oedema peripheral; Pyrexia; Skin nodule	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0105176	08/03/1998	UT	69.0	69		F	07/30/1998	pt recv vax 29OCT97 & 30OCT97 pt exp inj site redness, soreness & swelling (size of a baseball);pt did not tell the clinic;				Y					Y	10/29/1997	10/30/1997	1		PUB	PUB			unk	pt dx w/cellulitis w/pneumococcal vax;~ ()~~~In patient	WAES97110513	1						2	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~~3~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~MERCK & CO. INC.~0845D~3~~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0106962	08/03/1998	OK	65.0	65		F	07/30/1998	pt recv vax 27OCT97 & 28OCT97 pt exp fever, malaise, redness @ the inj site, swelling @ the site of inj to the elbow & the site was warm;pt recovered;									Y	10/27/1997	10/28/1997	1		PUB	PVT			unk	No relevant data;~ ()~~~In patient	WAES97102226	1						2	Injection site hypersensitivity; Injection site oedema; Malaise; Pyrexia; Vasodilatation; Injection site hypersensitivity; Injection site oedema; Malaise; Oedema peripheral; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4978140~1~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0106964	08/03/1998	OK	77.0	77		F	07/30/1998	pt recv vax 27OCT97 & 28OCT97 pt exp cellulitis the elbow, fever, pain & site warmth;pt recovered;									Y	10/27/1997	10/28/1997	1		PUB	PVT			unk	No relevant data;~ ()~~~In patient	WAES98060250	1						2	Cellulitis; Injection site reaction; Pain; Vasodilatation; Cellulitis; Pain; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4978140~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0106965	08/03/1998	OK	73.0	73		F	07/30/1998	pt recv vax 27OCT97 & 28OCT97 pt exp redness & swelling from inj site to the elbow & the reporting nurse noted that the site was warm;pt given DPH & APAP;									Y	10/27/1997	10/28/1997	1		PVT	PVT			unk	No relevant data;~ ()~~~In patient	WAES98060249	1						2	Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Vasodilatation; Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4978140~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0106966	08/03/1998	OK	70.0	70		M	07/30/1998	pt recv vax 27OCT97 & 28OCT97 pt exp redness & sl swelling @ the inj site & noted that site was warm;				Y					Y	10/27/1997	10/28/1997	1		PVT	PVT			unk	No relevant data;~ ()~~~In patient	WAES98060248	1						2	Oedema; Vasodilatation; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4978140~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0106968	08/03/1998	OK	70.0	70		M	07/30/1998	pt recv vax 27OCT97 & same day exp soreness @ the inj site;pt recovered from soreness @ inj site;									Y	10/27/1997	10/27/1997	0		PUB	PVT			unk	No relevant data;~ ()~~~In patient	WAES98060278	1						2	Injection site pain; Injection site pain	FLU3~PFIZER\WYETH~4978140~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~RA~PNEUMO (PNEUMOVAX)~1|DTP~UNKNOWN MANUFACTURER~~1~IM~~DTP (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0106996	08/03/1998	OK	85.0	85		F	07/30/1998	pt recv vax & exp pain @ the inj site;pt recovered from pain @ the inj site;									Y	10/27/1997				PVT	PVT			unk	No relevant data;~ ()~~~In patient	WAES98060246	1						2	Unevaluable event; Injection site pain	FLU3~PFIZER\WYETH~4978140~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0106998	08/03/1998	OK	38.0	38		F	07/03/1998	Information has been received from a registered nurse concerning a 38 year old female who on 27-OCT-1997 was vaccinated with pneumococcal vaccine 23 polyvalent and influenza virus vaccine IM in one injection. On 27-OCT-1997 the patient experienced pain at injection site. Subsequently, the patient recovered from pain at injection site. No further information is available.									Y	10/27/1997	10/27/1997	0		PVT	PVT			Unknown		WAES98060247	1						2	Unevaluable event; Injection site pain; Wrong technique in product usage process	FLU3~PFIZER\WYETH~4978140~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~IM~UN~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0113037	08/03/1998	FL	75.0	75		F	07/30/1998	pt recv vax & 9SEP97 pt exp soreness & a raised area @ the inj site;10SEP97 pt telephoned to report swelling & redness @ the inj site w/o any real pain;									Y	09/08/1997	09/09/1997	1		UNK	UNK	Premarin;provera;Zyrtec;			No relevant data;~ ()~~~In patient	WAES97091771	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0846D~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0113046	08/03/1998	FL	74.0	74		F	07/30/1998	pt recv vax 1OCT97 & on 2OCT97 pt c/o heaviness of arm;also said that arm was swollen, hot to touch, red & sore @ the site of inj;pt seen by MD who treated w/med;pt recovered;				Y					Y	10/01/1997	10/02/1997	1		PVT	PVT			codeine allergy;	No relevant data;~ ()~~~In patient	WAES97100365	1						1	Hypokinesia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Myasthenic syndrome; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0846D~2~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0113050	08/03/1998	CA	70.0	70		F	07/30/1998	3OCT97 pt devel erythema, macular papular rash, swelling & itchiness @ the inj site;pt also exp coughing & an itchy throat;pt recovered;									Y	10/03/1997	10/03/1997	0		OTH	OTH	lasix;potassium chloride;		breast malignant neoplasm;chronic obstructive pulmonary disease	~ ()~~~In patient	WAES97100711	1						1	Cough; Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0950D~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0113059	08/03/1998	NY	58.0	58		M	07/30/1998	pt recv vax 14OCT97 & same day pt exp instantaneous swelling @ the inj site & redness @ the inj site;									U	10/14/1997	10/14/1997	0		OTH	OTH			HTN	~ ()~~~In patient	WAES97101591	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0113078	08/03/1998	IA	66.0	66		M	07/30/1998	pt recv vax 16OCT97 & 17OCT97 pt exp significant tenderness & discomfort w/movement @ inj site;									Y	10/16/1997	10/17/1997	1		PUB	PUB			unk	No relevant data;~ ()~~~In patient	WAES97110166	1						1	Hypokinesia; Injection site pain; Pain	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0846D~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0113079	08/03/1998	NY	27.0	27		F	07/30/1998	pt recv vax 21OCT97 & 22OCT97 pt devel fever of 101, vomiting & inability to move the rt arm more than a 45 degree angle;									Y	10/21/1997	10/22/1997	1		PVT	OTH	Fiorinal;Flexeril;Triphasil;Flonase;Flovent;Maxzide;Synthride;synthroid;Zoloft		compazine allergy;allergy;asthma;	No relevant data;~ ()~~~In patient	WAES97110167	1						1	Hypokinesia; Pain; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0113086	08/03/1998	NM	58.0			M	07/30/1998	pt recv vax 13NOV97 & 14& 15NOV97 pt exp lymphadenitis;it was reported that the sx resolved w/in24hr to 7 days;									Y	11/13/1997	11/14/1997	1		UNK	UNK			unk	no relevant data~ ()~~~In patient	WAES97111671	1						1	Lymphadenopathy	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0113087	08/03/1998	WI	32.0	32		F	07/30/1998	pt recv vax 31OCT97 & 3NOV97 pt exp upper rt arm rxn consisting of redness, swelling & pain upon movement of the arm;also exp fever & was seen by MD;abscess;				Y					N	10/03/1997	11/03/1997	31		PVT	PVT	Flovent		unk	~ ()~~~In patient	WAES97111697	1						1	Abscess; Hypokinesia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0330D~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0113089	08/03/1998	FL	0.5	0	.5	M	07/30/1998	pt recv vax 14NOV97 & 19NOV97 pt exp fever of 99.4, inj site swelling, redness, & heat & congestion of the head & chest;pt felt like was hit by truck;to MD;throat red & postnatal drip;exp cough dx resp infect;				Y					U	11/14/1997	11/19/1997	5		PVT	PVT			ciprofloxacin allergy;codeine allergy	No relevant data;~ ()~~~In patient	WAES97111813	1						1	Infection; Injection site hypersensitivity; Injection site oedema; Lung disorder; Malaise; Pharyngitis; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0906E~1~SC~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0113103	08/03/1998	NJ	67.0	67		F	07/30/1998	pt recv vax 15DEC97 & pt exp fever for 3wk;									U	12/15/1997				UNK	UNK			splenectomy;	~ ()~~~In patient	WAES98010094	1						1	Pyrexia	DTP~UNKNOWN MANUFACTURER~~UNK~~~DTP (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0113104	08/03/1998	OK	45.0	45		M	07/30/1998	pt recv vax 27OCT97 & 28OCT97 pt exp cellulitis appearance 14x17cm described as edema in the rt arm extending to rt hand, induration, arm pain & redness & warmth @ the inj site;devel fever;seen in ER;				Y					Y	10/27/1997	10/28/1997	1		PVT	PVT	therapy unspecified thyroid		HTN, hypothyroidism;	No relevant data;~ ()~~~In patient	WAES98010143	1						1	Cellulitis; Injection site hypersensitivity; Injection site mass; Injection site pain; Oedema peripheral; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0845D~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0113161	08/03/1998	NJ				U	07/30/1998	15Dec97 recv pneumococcal vax 23 polyvalent.  Pt. exp. fever.  Pt. hosp 5Jan98.  Fever persisted month after vax.  Fever onset unknown.					Y				U	12/15/1997	01/05/1998	21		UNK	UNK	Corticosteroids (composition)		Hodgkin's lymphoma, chronic obstructive pulmonary disease, splenectomy	~ ()~~~In patient	WAES98050573	1						1	Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0113164	08/03/1998		71.0			M	07/30/1998	Pt recv vax and became ill promptly after. A diagnosis of giant cell arteritis was made and patient was treated w/prednisone.				Y					U	10/01/1996	10/01/1996	0		OTH	OTH			UKN	~ ()~~~In patient	WAES98051240	1						1	Arteritis; Malaise	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HIBV~PFIZER\WYETH~~UNK~~~HIB (HIBTITER)~1	USA	Emergency room visit	Influenza
0113259	08/06/1998	TX	51.0			F	08/03/1998	pt recv influenza vax became febrile with chills and myalgias. 4 wk later devel ear pain, h/a, blurry vision (both eyes). Eye exam acuity of 25/50 OD-20/25 OS visual field defect OD and super nasal defect OS, both optic disc edematous;								Y	N	10/01/1994				OTH	OTH				~ ()~~~In patient	MPI981625B	1						1	Amblyopia; Ear pain; Eye disorder; Headache; Myalgia; Pyrexia; Visual disturbance; Visual field defect	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0113260	08/06/1998	IN	47.0			F	08/03/1998	pt exp decrease vision OD & transient eye pain. Later devel blurriness in left eye, superior accurate defect OD, inferior latitudinal defect OS. Both optic discs moderately edematous w/ splinter hemorrhages & couon-wool spots;atrophy disc								Y	N	10/01/1994			serum protein electrophoresis w/immunofixation showed a nonspecific polyclonal hypergammglobulinemia;westergren test indicated sed rate midly elevated @ 44;	OTH	OTH			Mild strabismic amblyopia in right eye.	~ ()~~~In patient	MPI981625A	1						1	Amblyopia; Eye disorder; Eye pain; Immunoglobulins increased; Optic atrophy; Red blood cell sedimentation rate increased; Visual disturbance; Visual field defect; Amblyopia; Eye disorder; Eye haemorrhage; Globulins increased; Neuropathy; Optic atrophy; Papilloedema; Red blood cell sedimentation rate increased	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Disabling	Influenza
0113313	08/10/1998	MT	52.0	52		F		pt recv vax 3NOV97 & 1DEC97 pt c/ lt upper arm pain;stated it had come on p/vax & had worsened since that time;@ that time pt felt to have a deltoid tendonitis;pt put on med;pt still having deltoid tendonitis & pain under acromion;				Y						11/03/1997	12/01/1997	28	14JUN98 x-ray WNL	PUB	PVT	recv allergy shots every two weeks			~ ()~~~In patient	MT98020	1						1	Back pain; Injection site pain; Tendon disorder	FLU3~PFIZER\WYETH~4978146~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~UNKNOWN MANUFACTURER~438136~1~~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0113463	08/11/1998	CA				F	04/02/1998	pt recv vax 20OCT97 & devel brachial plexus neuropathy;				Y					Y	10/20/1997	11/18/1997	29		PVT	PVT	unk	unk		~ ()~~~In patient	898093021R	1						1	Arthralgia; Neck pain; Neuropathy; Pain	FLU3~PFIZER\WYETH~4978150~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0113464	08/11/1998	NY	48.0	48		M	04/10/1998	pt reported w/in 1wk of vax exp tiredness, sore chest;seen by MD;10NOV97 exp severe pain in feet & achilles tendons & numbness & cramping of feet;referred to neuro 9JAN98 d/t persistent pain;dx autoimmune rxn to vax; 60 day follow up states the neuropathy remains the same.				Y					N	10/25/1997	11/07/1997	13	nerve conduction studies: results reportedly consistent w/peripheral neuropathy;	PVT	OTH	NONE	NONE			898105003N	1						1	Asthenia; Hypertonia; Immune system disorder; Malaise; Myalgia; Neuropathy; Paraesthesia; Tendon disorder	FLU3~PFIZER\WYETH~4978195~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0113465	08/11/1998	NC				M	05/05/1998	6wk p/vax pt devel signs of cardiomyopathy thought to be of viral origin;									U					OTH	OTH	unk	unk		~ ()~~~In patient	898126055A	1						1	Cardiomyopathy; Infection	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0113466	08/11/1998	WA	51.0	51		M	05/29/1998	pt recv vax 18OCT97 & pt devel a blind spot in the lt eye & was seen by ophthalmologist;pt reported this event to primary MD in APR98;				Y				Y	N	10/18/1997				PVT	PVT	unk	NONE	newly diagnosed diabetic	~ ()~~~In patient	898154004A	1						1	Amblyopia; Eye disorder; Infection; Optic neuritis; Visual disturbance	FLU3~PFIZER\WYETH~4978150~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0113377	08/12/1998		57.0			F	08/11/1998	Pt history thoracic neuritis recv trivalent influenza devel urinary retention, adm to hosp medical exam revealed normal vital sign, the lower limb had one fifth strength, dec reflexes, inability to stand independently, bladder distended					Y				N	10/01/1994			Magnetic Resonance Imaging - Brain rev nonspecific white matter changes, Magnetic Resonance Imaging - Cervical and thoracic spine: abnormal signs with mild generalised oedema in the spinal cord, Myelin basis protein - 7.8ng/ml	OTH	OTH	Medroxy Progesterone/Medroxypro oestrogen/Oestrogen	History of thoracic neuritis	History of thoracic neuritis, right leg parasthesias and progressive leg weakness.	Pt was signifcant only for a febrile reaction to a previous influenza vax~ ()~~~In patient	MPI981667	1						1	CSF test abnormal; Depressed level of consciousness; Hypokinesia; Hyporeflexia; Myasthenic syndrome; Neuropathy; Paraesthesia; Urinary retention	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0113629	08/25/1998	WI	65.0	65		M	08/18/1998	pt w/a 3 day hx of numbness & tingling of the legs,hands & tongue hosp 30OCT w/severe weakness & inability to walk;dx GBS;plasmapheresis done;					Y	21			Y	10/21/1997	10/30/1997	9	WBC 5.7, VDRL NR, LP positive for GBS;spinal cult negative;CNS protein 919;tox screen showed arsenic 106;3NOV EMG showed gen sensory motor peripheral polyneuropathy;	OTH	OTH	Procardia XL, Zocor, Diclofenac, flexeril		hx of HTN, hyperlipidemia, spinal stenosis;	~ ()~~~In patient		1						1	Asthenia; CSF test abnormal; Guillain-Barre syndrome; Hypokinesia; Laboratory test abnormal; Neuropathy; Paraesthesia; Paraesthesia oral	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0113723	08/31/1998	TX	72.0	72		M	06/08/1998	that noc had acute onset of coughing for hr;couldn't sleep;devel heavy mucous in head & chest;cont 2wk;legs & abd became swollen;hosp;fluid around heart;tx several wk;tire very easily;CAT scan shows sinus mucous;nasal polyps;					Y				N	10/13/1997	10/13/1997	0		PVT	PVT	NONE			~ ()~~~In patient	TX98095	1						1	Abdominal distension; Asthenia; Cardiovascular disorder; Cough; Neoplasm; Oedema peripheral; Pharyngitis; Rhinitis	FLU3~MEDEVA PHARMA, LTD.~E333768~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0113865	09/03/1998	IL	19.0	19		F	08/31/1998	pt recv vax 12NOV97 & pt became preg;pt LMP was 22NOV97;3AUG98 pt delivered a 5lb 6.6 oz premature baby boy (35 wk gestation);preg uncomplicated but labor was complicated by 36hr of rupture of membrane @ time of delivery,loose nuchal cord;									Y	11/12/1997	08/03/1998	264		UNK	UNK	tuberculin purified protein		unk	~ ()~~~In patient	WAES98010632	1						1	Foetal disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~UNK~~~MENINGOCOCCAL (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~~TETANUS TOXOID (NO BRAND NAME)~1|YF~UNKNOWN MANUFACTURER~~UNK~~~YELLOW FEVER (NO BRAND NAME)~1	USA		Influenza
0113917	09/08/1998	AR	56.0	56		U	02/04/1998	rash, swelling of face, urticaria, angina & hypertension;1st noticed sl rash Friday PM;much worse Sat AM w/swelling, angina & hypertension;angioedema;had angina & Hypertension before;				Y	Y				Y	01/30/1998	01/31/1998	1		PUB	PUB		NONE	stable angina, HTN	~ ()~~~In patient	AK9199813	1						1	Angioneurotic oedema; Condition aggravated; Face oedema; Oedema; Rash; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E3257FA~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0906E~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0114085	09/11/1998	MI	36.0	36		F	09/08/1998	Pt recv vax on 9/4/98; on 9/5/98 pt exp redness of arm, itchy, and warm to touch about 4 in. circumference around injection site.									Y	09/04/1998	09/05/1998	1	N/A	PVT	PVT	N/A	N/A	N/A	UNK~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~963390~3~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0102680	09/15/1998	NY	52.0	52		F	08/29/1998	pain in muscles in all joints, many MD man medicines;it is 22mo since pt recv flu shot;the pain is now less severe, but not gone;anti-inflammatory drug given & pred;still as pain;									N	11/26/1996	11/28/1996	2	blood tests given each visit to MD office	PVT	PVT	NONE	NONE	irritable bowel symptoms	NONE~ ()~~~In patient		1						2	Arthralgia; Myalgia	FLU3~CONNAUGHT LABORATORIES~~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0114198	09/18/1998	OH	59.0			F	01/06/1998	pt devel acute loss of vision 2wk p/vax;on exam had bilat disk edema & could only perceive light in rt eye;could count fingers @ one foot w/lt eye;MRI negative, bloo cell count & chem unremarkable;dx bilat optic neuritis;optic disk pallor;					Y				Y				MRI negative;Blood cell count & chem: unremarkable;fluorescent trponemal antibody absorption: negative;antinuclear antibodies: negative;	OTH	OTH	unk	unk		pt devel bilat optic neuritis p/vax;~ ()~~~In patient	898245017A	1						1	Oedema; Optic atrophy; Optic neuritis; Visual disturbance	FLU3~PFIZER\WYETH~~1~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0114199	09/18/1998	OH	60.0			F	01/06/1998	pt devel acute loss of vision in both eyes 17 days p/vax;dx bilat optic neuritis made & pt treated w/IV corticosteriods;hosp is presumed, although not documented;visual acuity in rt eye returned to 20/30;only able to perceive light in lt ey					Y			Y	N					OTH	OTH	unk	unk		pt devel bilat optic neuritis p/vax;~ ()~~~In patient	898245018A	1						1	Optic neuritis; Visual disturbance	FLU3~PFIZER\WYETH~~2~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0114231	09/21/1998	NY	79.0	79		M	09/14/1998	cold sweats;tremors;light headedness;near syncope;					Y	11			Y	09/10/1998	09/10/1998	0	blood glucose=42 in Er	OTH	PVT	Uniphyl, Pred, Lasix, K-dur, atrovent	NONE	No known drug allergies	NONE~ ()~~~In patient	FLU85020998	1						1	Chills; Dizziness; Hyperhidrosis; Tremor	FLU3~PARKDALE PHARMACEUTICALS~02988P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0114258	09/21/1998	NY	71.0	70		F		cold sweats;tremors;lightheadedness;									Y	09/11/1998	09/11/1998	0	NONE	PVT	UNK	Calan SR 240, cardura	HTN & diabetes Mellitus	codeine	NONE~ ()~~~In patient	FLU85050998	1						1	Chills; Dizziness; Hyperhidrosis; Tremor	FLUX~UNKNOWN MANUFACTURER~02988P~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0114259	09/21/1998	NY	74.0	74		M	09/14/1998	cold sweats;slurred speech;tremors;lightheadedness;near syncope TIA like sx;									Y	09/09/1998	09/09/1998	0		PVT	PVT	Tenormin, Norvasc			NONE~ ()~~~In patient	FLU85060998	1						1	Cerebral ischaemia; Chills; Dizziness; Hyperhidrosis; Speech disorder; Tremor	FLUX~UNKNOWN MANUFACTURER~02988P~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0114260	09/21/1998	NY	77.0	77		M		cold sweats;tremors;lightheadedness;									Y	09/11/1998	09/11/1998	0		PVT	PVT	Vasotel, Valium	NONE	NKDA	NONE~ ()~~~In patient	FLU85040998	1						1	Chills; Dizziness; Hyperhidrosis; Tremor	FLUX~UNKNOWN MANUFACTURER~02988P~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0114296	09/23/1998	MD	52.0	52		F	09/21/1998	localized redness, swelling, itching, pain @ site of inj;apply cool pack to site;swelling 0.5cm, redness 5cm in width;claritin given;				Y					Y	09/15/1998	09/16/1998	1	NA	PVT	PVT	Plegine	NA	allergic rhinitis	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus	FLU3~CONNAUGHT LABORATORIES~0973920~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0114297	09/23/1998	MD	49.0	49		F	09/21/1998	localized redness, itching, swelling & pain @ inj site;cool pack to site;claritin given;				Y					Y	09/15/1998	09/16/1998	1	NA	PVT	PVT	Depacot;Wellbutrin	NONE	allergy PCN	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus	FLU3~CONNAUGHT LABORATORIES~0973920~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0114312	09/23/1998	AZ	65.0	65		M	09/15/1998	cold like sx-took OTC cold med per MD;chest congested, sl temp, SOB, coughing up alot of phlem;									Y	09/01/1989	09/01/1989	0	NONE	PVT	PVT	eyedrops;bronchitis med;BP meds;	NONE	bronchitis, BP, glaucoma;	~ ()~~~In patient		1						1	Cough; Dyspnoea; Pharyngitis; Pyrexia; Rhinitis; Cough; Dyspnoea; Infection; Pyrexia; Respiratory disorder; Salivary hypersecretion	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0114322	09/23/1998	AL	63.0	63		F	09/15/1998	pt recv vax 12:30 & almost 24hr later devel a whelp that is approx 2 1/2inches inwidest spot;									Y	09/14/1998	09/15/1998	1		PVT	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0114323	09/23/1998	MD	83.0	83		F	09/21/1998	redness, soreness, itching, swelling @ inj site;size of fifty cent piece;verbal report only;cool pack to be appllied to site;									U	09/19/1998	09/20/1998	1	NA	PVT	PVT	Glucophage	NONE	chronic conditions being treated;sulfa allergy;	pt daughter had rxn to flu vax same day;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus	FLU3~CONNAUGHT LABORATORIES~0973920~3~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0114324	09/23/1998	MD	49.0	49		U	09/21/1998	localized redness, pain @ swelling @ site of inj;size of fifty cent piece;verbal report only;did not come in;									U	09/19/1998	09/20/1998	1	NA	PVT	PVT	Allupernol;Claritin;Coumadin;Cardizem CD;Digoxin;Prempro	NONE	chronic conditions being treated;sulfa, darvon, chocolate allergies;	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0973920~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0114326	09/23/1998	MI	73.0	72		F	04/27/1998	unable to move on 12DEC97 thought had flu;next AM still unable to move so taken to ER;hx of heart problems;had pneumonia on adm;14FEB98 devel severe resp distress w/bronchospasm;severe encephalopathy w/quadriparesis dx GBS on 14DEC98;			Y		Y	30	Y		N	11/25/1997	12/12/1997	17		PUB	UNK	Insulin/caridac meds (husband unable to be specific)		coronary artery disease MAR97;HTN, diabetes;	~ ()~~~In patient	MI98088	1						1	Asthma; Dyspnoea; Encephalopathy; Guillain-Barre syndrome; Hypokinesia; Influenza; Paraesthesia; Pneumonia	FLU3~PFIZER\WYETH~4978196~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~4506~UNK~~LA~PNEUMO (PNU-IMUNE)~1	USA	Life Threatening,Hospitalisation	Influenza
0114487	09/29/1998	NY	81.0	81		F	09/24/1998	partial deafness								Y	U	10/27/1997	10/28/1997	1	MRI	PVT	OTH	Elthyroxin;Calan	unk	unk	~ ()~~~In patient	FLU86220998	1						1	Deafness permanent	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0092406	09/30/1998	MD	37.0	37		M	09/10/1997	Pt recv vax on 10/23/96; on 10/24/96 pt exp pain, swelling (.5 in diameter), redness, warmth, purpleness &skin eruptions at inject site, fever-104FX3dys, pain in right elbow, hand,hip &knee, myalgia, tiredness, weakness, anorexia,sweats>4dy				Y					U	10/23/1996	10/24/1996	1	UNK	PUB	PUB	NONE	NONE	Hay fever; allergic to all pollen, wheat,environmental dust &mold	UNK~ ()~~~In patient	897255009L	1						2	Anorexia; Arthralgia; Asthenia; Injection site hypersensitivity; Injection site oedema; Lymphadenopathy; Pyrexia; Vasodilatation; Asthenia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Lymphadenopathy; Myalgia; Myasthenic syndrome; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E2986FA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~PFIZER\WYETH~390966~1~IM~RA~PNEUMO (PNU-IMUNE)~2|FLU3~MEDEVA PHARMA, LTD.~E2986FA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~3|PPV~PFIZER\WYETH~390966~UNK~IM~~PNEUMO (PNU-IMUNE)~3	USA	Emergency room visit	Influenza
0105060	09/30/1998	OH	60.0	60		F	11/10/1997	5min p/vax pt exp itching @ the inj site & devel 0.25inch wheal w/a 2-inch flare about 2 inches below the inj site;several hr later rt arm became swollen & there was serous seepage from the swollen area;exp sl tingling & numbness;									Y	10/21/1997	10/21/1997	0		PVT	PVT	Premarin;	NONE	allergic to erythromycin (n/emesis) & flagyl;	~ ()~~~In patient	898110007L	1						2	Injection site hypersensitivity; Injection site oedema; Paraesthesia; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81884~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~440741~1~SC~RA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0105066	09/30/1998	MI	52.0	51		F	11/10/1997	pt recv vax & began to feel ill & lethargic;later that evening pt exp diff breathing, sweating & pallor;taken to ER tx w/02;devel irregular heart beat, indigestion & inj site rxn w/pain & redness;dx GERD;				Y					Y	11/05/1997	11/05/1997	0		OTH	OTH	unk	unk	fibromyalgia, severe osteoporosis;1wk prior to vax pt exsp an intestinal flu characterized by diarrhea & fever;tx lomotil;hx of nervous stomach & nervous heart-tachycardia;GERD	severe local rxn to tetanus toxoid several yr ago~ ()~~~In patient	897349022L	1						3	Arrhythmia; Dyspnoea; Gastrointestinal disorder; Hypoxia; Injection site hypersensitivity; Injection site mass; Injection site pain; Pallor; Arrhythmia; Chest pain; Condition aggravated; Dyspnoea; Gastrointestinal disorder; Hypoxia; Injection site hypersensitivity; Somnolence	FLU3~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~444067~1~IM A~~PNEUMO (PNU-IMUNE)~2|FLU3~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~3|PPV~PFIZER\WYETH~444067~1~IM A~~PNEUMO (PNU-IMUNE)~3	USA	Emergency room visit	Influenza
0105565	09/30/1998	VA	62.0	62		M	11/10/1997	Pt recv vax on 11/07/97; within 5 hr pt exp severe myalgia, pruritus & injection site rxn of swelling, redness &warmth; pt saw M.D.; tx=Benadryl, Advil &ice applications.				Y					Y	11/07/1997	11/07/1997	0	UNK	PVT	PVT	Relafen, Cytotec	NONE	Allergic to aspirin, phenobarbital, IVP dye; Pt has arthritis	UNK~ ()~~~In patient	898084026L	1						3	Injection site hypersensitivity; Injection site oedema; Myalgia; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81916~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~PFIZER\WYETH~445639~2~IM~RA~PNEUMO (PNU-IMUNE)~3	USA	Emergency room visit	Influenza
0105586	09/30/1998	VA	62.0	62		F	11/10/1997	Pt recv vax on 11/7/97; within 5 hr pt exp pain at injection site; pt tx=ice to the site &Advil.									Y	11/07/1997	11/07/1997	0	UNK	PVT	PVT	Naprosyn, Premarin, Norvasc	NONE	Hypertension	UNK~ ()~~~In patient	898084025L	1						2	Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81916~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~445639~1~IM~RA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0106361	09/30/1998	WI	75.0	75		F	12/16/1997	pt recv vax 1NOV97 & 2wk post vax pt called Md stating that exp pain in legs;pt then exp pain @ the site of pnu immune 23 administration;pain then spread over entire body;pt can hardly stand, walk or turn over in bed;									U	11/01/1997	11/15/1997	14		PUB	OTH	unk	NONE		~ ()~~~In patient	898015039L	1						3	Hypokinesia; Injection site pain; Pain; Hypokinesia; Pain; Gait disturbance; Hypokinesia; Injection site pain; Insomnia; Pain	FLU3~PFIZER\WYETH~4978172~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~4444075~1~IM~LA~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~4978172~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~444075~1~IM~LA~PNEUMO (PNU-IMUNE)~2|FLU3~PFIZER\WYETH~4978172~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~3|PPV~PFIZER\WYETH~444075~1~IM~LA~PNEUMO (PNU-IMUNE)~3	USA		Influenza
0107150	09/30/1998	MI	50.0	50		M	01/23/1998	Pt recv vax on 11/14/97; subsequently in Nov '97 pt exp tiredness&unwellness for 1 wk.On 1/3/98 pt exp ringing in ears; pt saw M.D.;dx sinus infection; tx=Augmentin.Pt saw ENT M.D.; 85% hearing loss noted;dx viral infection or autoimmune. Annual follow-up indicated that the pt experienced permanent hearing deficiency and required the use of hearing aids. As a result of follow-up info, this report has been reclassified as serious, unexpected.				Y					N	11/14/1997	11/15/1997	1	Hearing test-85% hearing loss; M.R.I., M.R.A., Blood tests-negative	PVT	PVT	NONE	NONE	UNK		898042013L	1						2	Deafness; Infection; Malaise; Tinnitus; Asthenia; Deafness; Immune system disorder; Infection; Malaise; Sinusitis; Tinnitus	FLU3~CONNAUGHT LABORATORIES~7F81895~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~444069~UNK~~~PNEUMO (PNU-IMUNE)~1|FLU3~CONNAUGHT LABORATORIES~7F81895~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~444069~1~IM~RA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0107693	09/30/1998	MI	63.0	63		F	05/08/1998	pt recv vax 16DEC97 & later that day devel an inj site rxn characterized by a 3cm area of redness, tenderness & warmth;there was another area of redness approx 1.5cm lower;tx w/ice & recovered w/in 2 to 3 days;									Y	12/16/1997	12/16/1997	0		PVT	PVT	Inodcin;Premarin;	NONE	Pseudogout	~ ()~~~In patient	898133034A	1						2	Injection site hypersensitivity; Injection site pain; Vasodilatation; Injection site hypersensitivity; Injection site pain; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4978141~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~448168~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~4978141~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~448168~1~IM~RA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0107694	09/30/1998	MI	66.0	66		F	05/08/1998	pt recv vax 1DEC97 & 2DEC97 pt devel an inj site rxn characterized by a 3inch area of redness, swelling & itching;tx w/DPH & cool compresses;									Y	12/01/1997	12/02/1997	1		PVT	PVT	NONE	NONE	hx of breast cancer	~ ()~~~In patient	898133035A	1						2	Injection site hypersensitivity; Injection site oedema; Pruritus; Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4978141~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~448168~1~SC~LA~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~4978141~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~448168~1~SC~LA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0108971	09/30/1998	VA	63.0	63		F	10/28/1997	12hr p/vax pt exp bronchospasm w/SOB & coughing;also devel an inj site rxn, w/redness & swelling @ site of vax;to ER where noted to be in severe resp distress;hosp;dx hypersensitivity rxn w/bronchospasm probably d/t flu vax & probable COPD				Y	Y	2			Y	10/23/1997	10/24/1997	1	arterial blood gas on 2 liters of 02-pH 7.356;PCO2-47;PO2-64.8;	PVT	PVT	NONE	NONE	hx of smoking, quit 9OCT97	pt recv 1 prev inj of influenza virus vax w/o adverse exp;~ ()~~~In patient	897353005L	1						2	Asthma; Cough; Dyspnoea; Hypoxia; Injection site hypersensitivity; Injection site oedema; Lung disorder; Asthma; Cough; Dyspnoea; Injection site hypersensitivity; Injection site oedema; Lung disorder; Respiratory disorder	FLU3~PFIZER\WYETH~4978153~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~1~IM~~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~4978153~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~~1~IM A~~PNEUMO (PNU-IMUNE)~2	USA	Hospitalisation	Influenza
0109117	09/30/1998	IL	46.0	46		M	10/03/1997	pt recv vax & devel fever, flu-like sx & an inj site rxn characterized by redness & raised bumps;				Y					Y	09/24/1997	09/26/1997	2		MIL	PUB	Dilantin;Lansopraxole	NONE	HTN, sleep apnea & sz activity	~ ()~~~In patient	897289019L	1						2	Influenza; Injection site hypersensitivity; Pyrexia; Influenza; Injection site hypersensitivity; Pyrexia	FLU3~PFIZER\WYETH~4978296~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~443660~1~IM~LA~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~4978296~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|OPV~PFIZER\WYETH~443660~1~IM~LA~POLIO VIRUS, ORAL (ORIMUNE)~2	USA	Emergency room visit	Influenza
0109154	09/30/1998	TX				M	10/21/1997	pt devel cellulitis  p/vax;flu shield & pnu immune mixed in same syringe;									U	10/15/1997				OTH	OTH	unk	unk		~ ()~~~In patient	897301010L	1						2	Cellulitis; Cellulitis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0109358	09/30/1998	NJ	48.0	48		F	11/05/1997	w/in a few min of vax pt exp generalized itching, felt hot all over, devel lumps @ site of pnu immune 23 administration;w/in 2 to 3 hr devel swelling & pain @ the pnu immune 23 site which extended from neck to fingers;seen by MD;ecchymosis				Y					Y	10/31/1997	10/31/1997	0		PVT	PVT	NONE	NONE	allergic to codeine	~ ()~~~In patient	898015036L	1						2	Ecchymosis; Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Pain; Pruritus; Vasodilatation; Ecchymosis; Injection site mass; Injection site oedema; Injection site pain; Oedema peripheral; Pain; Pruritus; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~444068~1~IM~LA~PNEUMO (PNU-IMUNE)~1|FLU3~MEDEVA PHARMA, LTD.~E32779A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~PFIZER\WYETH~444068~1~IM~RA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0111239	09/30/1998	FL	50.0	50		M	04/30/1998	pt recv vax 10OCT97 & donated blood 24DEC97 & was notified by the blood bank on 29DEC97 that MHA-TP testing was positive but FTA-ABS was negative;22JAN98 FTA-TP & RPR serology were non reactive;				Y					Y	10/10/1997	12/01/1997	52	24DEC97 MHA-TP positive;FTA-ABS negative;22JAN98 FTA-TP non reactive;RPR serology non reactive;	PVT	OTH	NONE	NONE		~ ()~~~In patient	898209001L	1						2	Laboratory test abnormal; Laboratory test abnormal	FLU3~PFIZER\WYETH~4978219~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~445642~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~PFIZER\WYETH~4978219~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~445642~1~IM~LA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0111256	09/30/1998	PA	82.0	82		F	10/29/1997	pt recv vax & the next day devel redness @ the inj site;event was dx as an allerg rxn;pt recovered;				Y					Y	10/21/1997	10/22/1997	1		PVT	PVT	unk	NONE		~ ()~~~In patient	897357020L	1						2	Hypersensitivity; Injection site hypersensitivity; Hypersensitivity; Injection site hypersensitivity	FLU3~PFIZER\WYETH~4978208~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~444070~1~IM~LA~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~49782008~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~444070~1~IM~LA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0114475	09/30/1998	MA	73.0	73		M	09/26/1998	28hr post vax pt exp sore throat & temp persisting for 2 days;									Y	09/23/1998	09/24/1998	1	NONE	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Pharyngitis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0114546	09/30/1998	GA	71.0			F	10/24/1997	several hr p/vax pt devel an inj site rxn characterized by tenderness, swelling which extended to the elbow & a baseball sized area of induration;									U	10/23/1997	10/23/1997	0		PVT	PVT	Glucotrol;Glucophage;unspecified antidepressent;	NOEN	non-insulin dependent diabetes mellitus, prev pneumococcal vax 10yr ago;	~ ()~~~In patient	897321027L	1						1	Injection site mass; Injection site oedema; Injection site pain; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~444068~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0114547	09/30/1998	GA	62.0			F	10/24/1997	several hr p/vax pt devel an inj site rxn characterized by a quarter sized area of induration, swelling, redness & tenderness;tx w/DPH;									U	10/23/1997	10/23/1997	0		PVT	PVT	Glucotrol;Glucophage	NONE	non-insulin dependent diabetes mellitus	~ ()~~~In patient	897321028L	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~444068~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0114548	09/30/1998	MN				U	10/24/1997	pt recv vax & devel fever 104, swelling of the arm into which pnu immune was injected, h/a, vomiting, puffy eyes & blurred vision;									U					OTH	OTH	unk	unk		~ ()~~~In patient	897329016L	1						1	Amblyopia; Face oedema; Headache; Oedema peripheral; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~442522~UNK~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0114555	09/30/1998	MI	25.0	25		M	11/21/1997	1 day p/vax pt devel fever of 102 & an inj site rxn w/redness, swelling & pain @ the site;seen by MD;WBC 15,900;blood cult negative;				Y					Y	11/17/1997	11/18/1997	1	WBC 15,900;blood cult negative;	PVT	OTH	Prilosec	unk		~ ()~~~In patient	897351040L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Leukocytosis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81749~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~442523~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0114556	09/30/1998	MI	44.0	44		U	11/21/1997	1 day p/vax pt devel an inj site rxn characterized by a 2cm to 3cm area of redness, swelling & pain;pt seen in ER;pt recovered;				Y					Y	11/19/1997	11/20/1997	1		PVT	OTH	unk	unk		~ ()~~~In patient	897351041L	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81749~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~442523~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0114557	09/30/1998	TX	30.0	30		F	11/24/1997	approx 4hr p/vax pt told the reporter could not move the injected arm;pt declined to be seen by the MD;by 6PM that day pt stated was much better & could move the arm;pain @ the inj site;									Y	11/20/1997	11/20/1997	0		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	897351042L	1						1	Hypokinesia; Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81898~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~448191~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0114558	09/30/1998	TX	50.0	50		M	11/26/1997	w/in 4hr of vax pt devel fever 102 w/chills, nausea, h/a, cold sweats & swelling of the inj arm;pt collapsed 3x;pt taken to ER where dx dehydration made;pt still exp fatigue;				Y					Y	11/10/1997	11/10/1997	0		PVT	PVT	unspecified allergy medication	NONE	unspecified allergies	~ ()~~~In patient	897351043L	1						1	Asthenia; Dehydration; Headache; Hyperhidrosis; Nausea; Oedema peripheral; Pyrexia; Syncope	FLU3~CONNAUGHT LABORATORIES~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~441212~1~IM A~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0114560	09/30/1998	WI	42.0	42		F	11/10/1997	pt recv vax & exp numbness & tingling of the rt arm;pt was examined by MD 7NOV97;MD noted approx 20% of reduction in sensation to touch on the posterior aspect of rt upper arm, rt forearm & dorsal aspect of ring & little finger;				Y					U	10/10/1997	10/11/1997	1		PUB	OTH	Prozac;Claritin D;Albuterol inhaler	NONE		~ ()~~~In patient	897352002L	1						1	Hypoaesthesia; Paraesthesia	FLU3~PFIZER\WYETH~4978161~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~440423~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0114561	09/30/1998	VA	66.0	66		F	11/03/1997	approx 12hr p/vax pt devel cellulitis @ the site of pun immune 23 administration;tx w/keflex & voltaren & recovered;									Y	10/30/1997	10/30/1997	0		PVT	PVT	amantadine;amoxicillin;Prinizzide;	upper resp infect	allergic to codeine;	~ ()~~~In patient	897357014L	1						1	Cellulitis; Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~7F81916~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~445640~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0114564	09/30/1998	FL	31.0	31		F	11/03/1997	2 days p/vax pt devel cellulitis @ the pnu immune 23 inj site;pt was seen in ER dx of cellulitis made;tx w/ATB & advil;				Y					U	10/28/1997	10/30/1997	2		PUB	PVT	NONE	NONE		~ ()~~~In patient	897357017L	1						1	Cellulitis; Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~444068~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0114565	09/30/1998	AL	34.0	34		F	12/08/1997	pt recv vax & 2 days later devel an inj site rxn w/redness & soreness @ the site of pnu immune 23 administration;pt given DPh;									U	12/04/1997	12/06/1997	2		OTH	OTH	unk	NONE		~ ()~~~In patient	897357018L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81931~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~442520~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0114566	09/30/1998	AL	33.0	33		M	12/08/1997	pt recv vax & devel an inj site rxn w/redness & soreness @ the site of pneumonia immune immune 23 administration;									U	12/04/1997				OTH	OTH	unk	NONE		~ ()~~~In patient	897357019L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81931~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~442520~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0114568	09/30/1998	PA	71.0	71		F	10/29/1997	pt recv vax & the next day devel an inj site rxn w/swelling, warmth & redness;by 30OCT rxn had extended to hand;dx as an allerg rxn;pt recovered;				Y					Y	10/28/1997	10/29/1997	1		PVT	PVT	unk	NONE	this pt recv an inj of pnu imune 23 in 1996;allergic to IV fluorescein dye;	~ ()~~~In patient	897357021L	1						1	Hypersensitivity; Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4978208~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~444070~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0114569	09/30/1998	NY				U	10/27/1997	pt recv vax & later that day felt bad & devel an inj site rxn w/redness & swelling;									U					PVT	OTH	unk	unk		~ ()~~~In patient	897358005L	1						1	Injection site hypersensitivity; Injection site oedema; Malaise	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~442519~UNK~IM A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0114574	09/30/1998	PA				F	12/05/1997	pt recv vax & w/in 24hr devel redness & pain @ the site of vax;tx w/DPH;									U	12/01/1997	12/02/1997	1		PVT	OTH	unk	unk		~ ()~~~In patient	898006008L	1						1	Injection site hypersensitivity; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~448174~1~IM A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0114582	09/30/1998	PA	66.0	65		F	12/12/1997	w/in 4hr of vax pt devel an inj site rxn characterized by inflammation, swelling & pain which extended from the shoulder to wrist;tx w/applications of ice & heat & APAP;									Y	11/24/1997	11/24/1997	0		PVT	OTH	Inderal;Estrogen;Dilantin	NONE	prev dose of pneumococcal vax given 1991;	~ ()~~~In patient	898015024L	1						1	Injection site inflammation; Injection site oedema; Injection site pain; Oedema peripheral; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~~2~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0114613	09/30/1998	FL	55.0	55		F	11/20/1997	Pt recv vax on 11/13/97; on 11/15/97 pt exp injection site rxn; pt seen in E.R.; dx cellulitis; tx=Cefadroxil X10dy.  As of 11/20/97 redness was subsided.				Y					U	11/13/1997	11/15/1997	2	UNK	OTH	OTH	NONE	NONE	UNK	UNK~ ()~~~In patient	898084022L	1						1	Cellulitis; Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~7F81802~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~448187~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0114641	09/30/1998	LA	50.0	50		M	12/22/1997	pt recv vax 22AUG96 & 19DEC97 hosp w/pneumococcal pneumonia & sepsis;			Y		Y				Y	08/22/1996	12/19/1997	484	atrovent inhaler 3 puffs 4-5 times daily inhalant;stelazine;elavil;catapress;	PVT	OTH	Accupril;Aerobid inhaler;	unk	HTN, diabetes mellitus, depression, COPD	~ ()~~~In patient	897364007L	1						1	Drug ineffective; Infection; Pneumonia; Sepsis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|OPV~PFIZER\WYETH~429350~1~IM~RA~POLIO VIRUS, ORAL (ORIMUNE)~1	USA	Life Threatening,Hospitalisation	Influenza
0114660	10/02/1998	PA	42.0	42		F	09/28/1998	throat tightening & coughing & erythema;responded to DPH & Epi x 2 & dexamethasone & now on steroids;				Y					Y	09/25/1998	09/25/1998	0	NONE	PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Cough; Laryngospasm; Rash	FLU3~CONNAUGHT LABORATORIES~0968410~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0114721	10/05/1998	NM	23.0	23		F	09/28/1998	pt c/o pain, swelling, redness & rash @ inj site approx 24hr p/vax;swelling inc p/48hr of inj;site red, swollen & is producing heat;inj site erythema, >5cm or subcutaneous nodules or pruritus @ site;									Y	09/25/1998	09/26/1998	1		MIL	MIL	BCP, Midirin PRn	NONE	PCN allergy	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Pruritus; Vasodilatation	ANTH~MICHIGAN DEPT PUB HLTH~FAV030~2~SC~LA~ANTHRAX (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~017971070~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0114722	10/05/1998	NM	25.0	25		F	09/28/1998	pt c/o redness, swelling & pain @ inj site ;pt states swelling/redness is increasing every day;									Y	09/25/1998	09/25/1998	0		MIL	MIL	Depo provera;	NONE	gastritis;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	ANTH~MICHIGAN DEPT PUB HLTH~FAV030~2~SC~LA~ANTHRAX (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~017971070~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0114723	10/05/1998	NM	22.0	22		F	09/30/1998	pt c/o loose stool w/orange tinted mucoid component 24hr p/vax ongoing for 1wk;lower abd cramping noted;									N	09/22/1998	09/23/1998	1		MIL	MIL	NONE	NONE	NONE	~ ()~~~In patient		1						1	Abdominal pain; Abnormal faeces; Diarrhoea	ANTH~MICHIGAN DEPT PUB HLTH~FAV030~2~SC~~ANTHRAX (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~0971707~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0114731	10/05/1998	AL	47.0	47		F	10/02/1998	numbness in body, dizzy, extreme weakness, hard to walk;inflammation in brain & spinal cord;no cure only tx is steroids; transverse myelitis;					Y	5		Y	N	11/12/1997	03/01/1998	109	transverse myelitis	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient	AL9811	1						1	Anorexia; Asthenia; Delirium; Depressed level of consciousness; Diarrhoea; Dizziness; Hypokinesia; Myelitis; Neuropathy; Paraesthesia; Asthenia; Delirium; Depressed level of consciousness; Dizziness; Hypokinesia; Myelitis; Pain; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E20067KF~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~E20067KF~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation,Disabling	Influenza
0114736	10/05/1998	NC	69.0	68		M	09/30/1998	c/o vertigo, coordination problem, laryngitis & URI;18SEP98 strange sensation in arms;numbness of arms, legs & face;unable to r/o GBS @ this time;poss sensory neuropathy;flu;problems starting urine;arterial insufficiency;					Y				U	09/09/1998	09/10/1998	1	CO2 total 32;urea nitrogen 29;uric acid 3.0;Iron, total serum 21;hemoglobin 12.0;HCT 38.1;MCHC 31.5;RDW 15.1;polys 73;lymph 17;EOS 1;BP 102/70;	UNK	UNK	Pred;ASA;Viagra-antivert & vitamins;		low Hgb 12-12.5, elevated sed rate (been to 32);possible polymyalgia rheumatic;s/p arthroscopic lt shoulder surgery AUG94;? TA w/h/a & scalp tingling;			1						1	Cardiovascular disorder; Coordination abnormal; Dysuria; Guillain-Barre syndrome; Influenza; Laryngitis; Neuropathy; Paraesthesia	FLU3~SANOFI PASTEUR~0975860~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0114312	10/06/1998	AZ	65.0	65		M	09/29/1998	had a chest infect, started to do a lot of coughing of clear white sputum also a temp;ran out of breath very easy;called MD said take 12hr control cold treatment which did not help;									Y	09/01/1989	09/01/1989	0	NONE	PVT	PVT	B/P vasotec;babyaspirin;Theodur;Vancerel;Ventolin	NONE	bronchitis, BP glaucoma;	~ ()~~~In patient		1						2	Cough; Dyspnoea; Pharyngitis; Pyrexia; Rhinitis; Cough; Dyspnoea; Infection; Pyrexia; Respiratory disorder; Salivary hypersecretion	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0114772	10/07/1998	CA	36.0	35		U	10/06/1998	throat burning, felt like throat & tongue swelling;945AM DPH;10AM DPH;									Y	10/05/1998	10/05/1998	0	oximetry-98% 02 sat;	PUB	PVT	DPH;Vitamins	NONE	latex	NONE~ ()~~~In patient		1						1	Laryngospasm; Pharyngitis; Tongue oedema	FLU3~MEDEVA PHARMA, LTD.~20168GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0114774	10/07/1998	GA	35.0	34		F	10/02/1998	pt recv vax 1OCT98 & returns to clinic 2OCT98 w/raised reddened area @ inj site;									Y	10/01/1998	10/02/1998	1	NONE	PUB	PUB		NONE	NONE	~ ()~~~In patient	GA98078	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~MEDEVA PHARMA, LTD.~E20148HD~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0114779	10/07/1998	MD	50.0	50		F	10/02/1998	redness, swelling, hot to touch;localized rxn size of quarter;verbal report per pt 2wk p/incident;									Y	09/18/1998	09/19/1998	1	NA	PVT	PVT		NONE	ceclor allergy-rash	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0973920~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0114804	10/08/1998	CA	38.0	37		F	10/03/1998	pt recv vax 24SEP98 & became ill next day,large red welt, 3 x 5 on upper arm, fever, flu sx;called MD given DPH & advil & call next day; next day bright red welt inc & flu sx, pain in neck & shoulder, aches & pains,fever, disorientation									N	09/24/1998	09/25/1998	1		PVT	PVT	Prilosec, Thyrolar, claritin,iroxicam, ortho cyclen	NONE	allergic to bee sting;	~ ()~~~In patient		1						1	Arthralgia; Influenza; Malaise; Myalgia; Neck pain; Pyrexia; Urticaria; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~20198HA~5~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0114810	10/08/1998	HI	42.0	42		F	10/01/1998	red, raised wheal 1inch by 1.5inch w/in 24hr of vax @ inj site lt deltoid;									Y	09/23/1998	09/24/1998	1	NA	PUB	OTH				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~0971880~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0114821	10/09/1998	OH	50.0	49		F	10/08/1998	sneezing, low fever 99-100, severe muscle ache-neck & arms, calves of legs as compared to prev;diarrhea;									U	10/05/1998	10/05/1998	0		OTH	PVT	NONE	NONe	allergies-PCN, mold;no chronic health problems;	~ ()~~~In patient		1						1	Diarrhoea; Myalgia; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0973930~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0114824	10/09/1998	NY	68.0	68		F	10/06/1998	pt recv vax & started feeling pain in rt arm & neck;could not raise arm above head;no induration, no point tenderness;good muscle strength but unable to raise arm to head;afeb;warm soaks;suggest bengay;6OCT98 still sore unable to lift arm				Y					U	10/01/1998	10/02/1998	1	NONE	OTH	OTH		NONE	inc BP on procardia  XL	~ ()~~~In patient		1						1	Hypokinesia; Myalgia; Neck pain; Pain	FLU3~CONNAUGHT LABORATORIES~0971880~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0114826	10/09/1998	OK	42.0	42		F	10/01/1998	w/in 5min of vax pt reported burning in chest area above breast;pt went back to work 30-40min p/vax c/o burning & heaviness in chest area;no SOB;BP 170/100, P88 R 20BP 150/99;chest pain;				Y					Y	10/01/1998	10/01/1998	0		PUB	PVT	glucotrol	NONE	diabetes, heart valve-never followed up	~ ()~~~In patient		1						1	Chest pain; Hypertension	FLU3~CONNAUGHT LABORATORIES~0966960~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0114873	10/13/1998	FL	41.0	41		M	10/06/1998	tingling, numbness in vaccinated arm spreading to top of head, face, entire torso lt side;heart racing, nauseated, lightheaded;had to pull over roadside call 911;pulse & BP very high;resolved p/1hr;				Y					Y	10/01/1998	10/01/1998	0	CAT scan;bloodwork;drug screen-all negative;	OTH	PVT		NONE	mango-produced arthralgia requiring physicl therapy	~ ()~~~In patient		1						1	Dizziness; Hypertension; Nausea; Paraesthesia; Tachycardia	FLU3~CONNAUGHT LABORATORIES~0978720~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0114877	10/13/1998	NV	51.0	51		F	07/01/1998	pt recv vax & 2-3wk later weakness upper arms & chest-intermittent pin prick in finger tips & eyelids intermittent sharp pain lt shoulder blade, vision occasionally blurred-general weakness/malaise;				Y					N	10/01/1996	11/01/1996	31	CXR, blood test, MRI-brain-tested for MS, lupus;saw 2 neurologists,1 rheumatologist;	PVT	PVT	Hormones;Fosamax	NONE	NONE	NONE~ ()~~~In patient	NV98017A	1						1	Amblyopia; Asthenia; Back pain; Malaise; Myasthenic syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0686P~5~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0114878	10/13/1998	NV	52.0	52		F	07/01/1998	pt recv vax &  devel pain @ inj site x 1wk;no other problems;				Y						10/01/1997				PVT	PVT	Hormones;Fosamax;	NONE	NONE	pt exp weakness,  pin prick in finger tips & eyelid, sharp pain,vision blurred~ ()~~~In patient	NV98017B	1						1	Injection site pain	FLUX~UNKNOWN MANUFACTURER~~6~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0114882	10/13/1998	SD	1.3	1	.3	F	10/12/1998	pt recv vax & mom called 330PM stating daughter had 3 episodes of vomiting;recommend to keep NPO for 4hr & then to start clear liquids & to advance to 1/2 strength milk as tolerated;									Y	10/09/1998	10/09/1998	0	NA	PVT	PUB	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Anorexia; Vomiting	FLU3~PARKDALE PHARMACEUTICALS~02198P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HIBV~PFIZER\WYETH~1100H~4~IM~RL~HIB (HIBTITER)~1|MMR~MERCK & CO. INC.~0741E~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0114883	10/13/1998	TX				U		local angioedema @ inj site;									Y	10/06/1998	10/08/1998	2		PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Angioneurotic oedema; Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~0980560~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0114885	10/13/1998	CA	39.0	39		F	10/08/1998	pt recv flu shot & T102, chills, shaking, n/v, diarrhea noc p/vax;localized rxn lt deltoid;									Y	10/07/1998	10/08/1998	1	NONE	PUB	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						1	Diarrhoea; Injection site reaction; Pyrexia; Tremor; Vomiting	FLU3~CONNAUGHT LABORATORIES~0965780~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0114896	10/13/1998	IL	72.0	72		M	10/01/1998	30SEP98 AM pt recv vax x 2 noted discomfort, stiffness & swelling in lt arm surrounding inj site @ 5PM;pt applied ice & took ecotrin for pain;shaking, chills during PM;swelling noted 2 above antecubital space;pain, warm & tender;T36.6;									U	09/30/1998	09/30/1998	0		PVT	PVT				~ ()~~~In patient		1						1	Chills; Hypertonia; Hypothermia; Injection site oedema; Injection site pain; Pain; Tremor; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0978690~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~448516~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0114906	10/13/1998	VA	13.0	13		F	10/05/1998	Pt recv vax on 10/3/98; approx 2 hr later pt exp hives over entire body; itchy throat.									Y	10/03/1998	10/03/1998	0	UNK	PUB	PVT	UNK	NONE	Allergic to cocoa, ginger; Posion oak rx 2 mon ago.	~ ()~~~In patient	VA98063	1						1	Pharyngitis; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4988212~7+~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0114916	10/13/1998	CO	21.0			F	10/06/1998	110PM nurse observed pt rt arm to see if any local rxn since this was 1st flu vax;pt arm was red/swollen, itchy;nurse proceeded  to obtain ice to put on arm then pt c/o dizziness on & off;severe h/a;clammy & sweaty;on 02;nail bed cyanotic									Y				Bp 130/80, AP 104 R 18;120PM BP 130/70, 108, 16;125PM BP 140/80,	PUB	UNK		NONE	NONE	NONE~ ()~~~In patient		1						1	Cyanosis; Dizziness; Headache; Hyperhidrosis; Hypertension; Hypoxia; Oedema peripheral; Tachycardia	FLU3~CONNAUGHT LABORATORIES~0967030~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0114927	10/13/1998	MI	39.0	39		F	09/30/1998	pt recv vax 29SEP98 1PM & 115PM wheezing-inhaled 2 puffs proventil @ work site;130PM c/o wheezing, itchiness @ inj site;130PM DPH given P86, R24;redness noted @ inj site;cont wheezing c/o lightheadedness noted;diff breathing;				Y	Y	2			Y	09/29/1998	09/29/1998	0	145PM PDH P88, R34 wheezing;155PM to ER 02 w/staff driving/assisting;	PUB	PUB		hx of asthma	allergy PCN, ASA, epi (susphrine)	NONE~ ()~~~In patient	MI98111	1						1	Asthma; Dizziness; Dyspnoea; Hyperventilation; Hypoxia; Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~0965760~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0114928	10/13/1998	CA				U	09/30/1998	pt recv vax & exp low back pain, flu sx, arm soreness & weakness;pt hosp;flu sx resolved p/3 days;					Y				Y					OTH	OTH	unk	unk		~ ()~~~In patient	898274034A	1						1	Asthenia; Back pain; Influenza; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~454380~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0114929	10/13/1998	CA				U		pt recv vax & exp low back pain, flu sx, arm soreness & weakness;pt hosp;flu sx resolved p/3 days;the weakness resolved p/ 5 days;					Y				Y					OTH	OTH	unk	unk		~ ()~~~In patient	898280004L	1						1	Asthenia; Back pain; Influenza; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~454380~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0114948	10/13/1998	MA	54.0	54		F	10/07/1998	grittiness in both yes on 16OCT96 same evening pt was given flu shot;w/in 6 days pt blind;given pred which improved sight;pt permanently blind;optic nerve dysfunction;pt states optic neuritis followed flu vax;myelitis;myelopathy;spasm;weak					Y	6		Y	N	10/16/1996	10/16/1996	0	CT scan, x-rays, spinal tap	PUB	UNK	several for heart, diabetes, BP	heart, diabetes	NONE	~ ()~~~In patient		1						1	Blindness; Depressed level of consciousness; Hypertonia; Myasthenic syndrome; Myelitis; Optic neuritis; Pupillary disorder; Visual disturbance	FLU3~PARKE-DAVIS~00476P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation,Disabling	Influenza
0114954	10/14/1998	NC				F	10/09/1998	body itching-raised bumps/hives 6hr post vax;pt started methylprednisone w/in 24hr p/vax;				Y					U	10/08/1998	10/08/1998	0	NA	PVT	PVT	Maxide	NONE	NONE	NONE~ ()~~~In patient		1						1	Pruritus; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E20148HD~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0114955	10/14/1998	MO	58.0	58		F	10/05/1998	rash-hives, diff breathing approx 2hr p/vax;tx w/DPH;				Y					Y	10/03/1998	10/03/1998	0	NONE	PUB	PVT		NONE		~ ()~~~In patient		1						1	Dyspnoea; Rash; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~02198P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0114956	10/14/1998	PR	47.0	47		F	10/02/1998	resp distress;rx solumedrol, DPH, FFT w/ proventyl;				Y					Y	09/29/1998	09/30/1998	1	NONE	PUB	PUB	Prinventyl;pred;theodur	AB	NKA	~ ()~~~In patient		1						1	Dyspnoea	FLU3~CONNAUGHT LABORATORIES~0971880~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~0908180~2~IM A~~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0114959	10/14/1998	MI	72.0	72		F	10/09/1998	rt arm stiffness, pain, blotchy red rash covering shoulder to hand, breathing difficulties;				Y					Y	10/06/1998	10/06/1998	0		UNK	UNK		heart condition	tenormin, darvocet	~ ()~~~In patient		1						1	Dyspnoea; Hypertonia; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~0977210~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1173E~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0114962	10/14/1998	CA	47.0	47		M	10/01/1998	1/2 bruise p/flu shot, unresolved 1wk later;somewhat painful (bled initially);									U	09/22/1998	09/22/1998	0	NA	PVT	UNK	Phenobarbital, dilantin	cerebral palsy since birth	wheelchair bound; sz (controlled)	~ ()~~~In patient		1						1	Ecchymosis; Haemorrhage; Pain	FLUX~UNKNOWN MANUFACTURER~~5~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0114971	10/14/1998	MA	41.0	41		M	10/09/1998	fever, malaise, myalgia									U	10/08/1998	10/08/1998	0		PVT	PVT	Prilosec;Adalat	NONE	HTN, GERD;	~ ()~~~In patient		1						1	Malaise; Myalgia; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~03788P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0114974	10/15/1998	MI	58.0	58		F	10/08/1998	heart started racing, dizzy, did not sleep all noc, agitated, anxiety arm swollen & red;rx beta blocker, DPH oral & site application;			Y	Y						10/07/1998	10/07/1998	0	BP 150/110;EKG nl;HR high;	PVT	PVT	Primprol	NONE	sinus drainage, (allergies?)	~ ()~~~In patient		1						1	Agitation; Anxiety; Dizziness; Insomnia; Oedema peripheral; Tachycardia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0114979	10/15/1998	MA	65.0	65		F	10/07/1998	swollen, inflamed arm;rxn in rt arm MD said like a big hive;				Y					N	09/27/1998	09/27/1998	0		UNK	UNK				~ ()~~~In patient		1						1	Oedema peripheral; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0114980	10/15/1998	IN	37.0	37		F	10/07/1998	elevated temp;no local rxn @ site;SOB;swollen face;dx rxn				Y					U	10/02/1998	10/02/1998	0		UNK	UNK				~ ()~~~In patient		1						1	Dyspnoea; Face oedema; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0969600~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0114986	10/15/1998	HI	5.0	5		M	10/06/1998	approx 35min p/vax given pt & father returned w/child eyelids swollen, red w/hives around neck & upper lids, wheezing devel;									Y	10/02/1998	10/02/1998	0	NONE	PVT	UNK	Nasacort;DPH		severe asthma, microcephaly & develdelay s/p G tube	~ ()~~~In patient		1						1	Asthma; Condition aggravated; Conjunctivitis; Face oedema; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975790~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0114989	10/15/1998	OK	45.0	45		F	10/12/1998	redness/swelling @ 1inch, warm to touch;									Y	10/02/1998	10/02/1998	0		PVT	PVT				~ ()~~~In patient		1						1	Oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0968380~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0114990	10/15/1998	OR	40.0	39		F	10/13/1998	pt had redness/swelling @ 1inch lasted 2 days;									Y	10/08/1998	10/08/1998	0		PVT	PVT				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~0968380~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0114991	10/15/1998	OR	10.0	10		F	10/13/1998	pt had redness/swelling @ 1 inch lasted @ 2 days;									Y	10/12/1998	10/12/1998	0		UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~0968380~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0114992	10/15/1998	OK	4.0	4		M	10/13/1998	pt had redness/swelling @ 1 inch lasted 2-3 days;									Y	10/09/1998	10/10/1998	1		UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~0968380~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0114993	10/15/1998	NY	45.0	45		F	10/08/1998	12hr p/vax tenderness in lt axilla;24hr p/vax lt axillary lymph glands tender, very swollen lasted 12-18hr;									Y	10/02/1998	10/02/1998	0		PUB	UNK	NONE	NONE	NA	~ ()~~~In patient		1						1	Injection site pain; Lymphadenopathy	FLU3~CONNAUGHT LABORATORIES~0975850~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0114994	10/15/1998	UT	78.0			M	10/10/1997	n/v, erythema, rash, induration;										10/03/1997	10/09/1997	6		UNK	UNK	APAP, DIgoxin, AMiadron, Albutrol, Atrovent;		no allergy hx documented;	~ ()~~~In patient		1						1	Rash; Skin nodule; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115001	10/15/1998	CO	60.0	60		F	10/08/1998	4hr post vax diarrhea, fever, aches, dizzy, a lot of pain;									N	10/07/1998	10/07/1998	0	NONE	OTH	OTH	NONE	NONE	dust, pollen allergies	pt exp sore, low grade temp w/flu vax;~ ()~~~In patient		1						1	Diarrhoea; Dizziness; Myalgia; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115002	10/15/1998	UT	28.0			M	10/07/1998	stomach cramping, diarrhea, began to have chickenpox looking bumps on chest, abd legs;														UNK	UNK				~ ()~~~In patient		1						1	Abdominal pain; Dermatitis bullous; Diarrhoea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0115003	10/15/1998	PA	52.0	51		F	10/07/1998	localized redness & swelling @ inj site, h/a, cough, body aches, sl temp;									Y	10/04/1998	10/04/1998	0	NONe	OTH	PUB	NONE	NONE	hayfever, asthma	pt & mom exp local redness, swelling inj site, h/a, cough, aches, temp w/flu vax~ ()~~~In patient		1						1	Cough; Headache; Injection site hypersensitivity; Injection site oedema; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0967040~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115031	10/16/1998	CA	42.0	41		F	10/09/1998	pt recv vax 10AM on 8OCT98 approx 1045AM felt hot & itched-generalized;reported to med clinic @ work & recv treatment;returned to work p/leaving med clinic;				Y					Y	10/08/1998	10/08/1998	0		OTH	OTH	vitamins, niacin	denies	asthma	~ ()~~~In patient		1						1	Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0972850~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0115033	10/16/1998	IN	78.0	78		F	10/15/1998	hives, weakness, dizziness, itching;				Y					Y	10/12/1998	10/12/1998	0	NONE	PVT	OTH	unk numerous	NONE	allergy to cough syrup	~ ()~~~In patient		1						1	Asthenia; Dizziness; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0115034	10/16/1998	MA	30.0	30		F	10/10/1998	severe localized rxn @ inj site;size of tennis ball-hot to touch, red, purple, h/a, fever, chills, gen flu sx, nausea, vomiting, could not keep food down;				Y					N	10/06/1998	10/07/1998	1	NONE	PVT	PVT	Theodur;Proventil	NONE	asthma, tetracycline & sulfa drugs;	~ ()~~~In patient		1						1	Anorexia; Ecchymosis; Headache; Influenza; Injection site hypersensitivity; Injection site mass; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0115035	10/16/1998	OR	58.0	58		F	10/09/1998	bilat swelling below both ears, redness of the ear lob, low grade temp, bilat tender rx pred;cervical adenopathy 5cm below rt earlobe;				Y					N	10/08/1998	10/08/1998	0	BP 110/72 vitals stable	PVT	PVT	glyberide;zestril;motrin	sl cough (dust, irritation)	PCn/erythromycin allergy hx diabetes, HTN, kidney problems;	pt felt ill w/flu vax~ ()~~~In patient		1						1	Face oedema; Lymphadenopathy; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0115036	10/16/1998	TX	65.0	65		F	10/12/1998	began itching breakout w/red splotches all over body,  erythematous macules to arm legs, trunk, abd, no drainage, periorbital edema;pupils equal, ear, nose, throat, heart & lung ok;				Y					N	10/09/1998	10/09/1998	0	NONE	PVT	PVT	premarin;Arazapan;medrol dose pack	NONE	NONE	~ ()~~~In patient		1						1	Face oedema; Pruritus; Rash maculo-papular	FLU3~PARKDALE PHARMACEUTICALS~03788P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0115038	10/16/1998	MS	45.0	45		F	10/15/1998	pt stated that about 25min p/vax exp wheezing, diff breathing, fast heart beat, & edema of the face;states took DPH & used some prescription nasal spray for asthma;dx rxn to flu vax;									Y	10/06/1998	10/06/1998	0		PUB	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Asthma; Dyspnoea; Face oedema; Tachycardia	FLU3~CONNAUGHT LABORATORIES~0975770~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115039	10/16/1998	NY	32.0	32		F	10/10/1998	dizziness, upset stomach, clamminess, itchiness, sl rash;									N	10/06/1998	10/08/1998	2	NONE	PVT	OTH	tavist D;birth control	NONE	asthma, upper resp allergies;	~ ()~~~In patient		1						1	Dizziness; Dyspepsia; Hyperhidrosis; Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115044	10/16/1998	CA				F	10/09/1998	15 to 20 p/vax dizziness, sweating;next day local rash;									Y	10/07/1998	10/07/1998	0	BP measured @ 240PM 120/80	PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Dizziness; Hyperhidrosis; Rash	FLU3~CONNAUGHT LABORATORIES~0975860~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115047	10/16/1998	SC	44.0	44		F	10/09/1998	pt recv vax 28SEP98 & exp severe muscle pain in both legs started 2OCT98 PM became sores 3OCT98 AM diff walking w/problems of coordination, ?fever was taking motrin;									Y	09/28/1998	10/02/1998	4		PUB	UNK	Accupril;synthroid;Priloset	NONE	HTN, thyroid problems, hiatial hernia;	NONE~ ()~~~In patient		1						1	Coordination abnormal; Hypokinesia; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0978670~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115095	10/18/1998	VA	56.0	56		F	10/12/1998	9OCT98 approx 5PM 7hr p/vax had queasy feeling;12hr p/vax felt bad had chills, fever (temp not taken) inj site rt arm swollen & neck w/pain, heart rate rapid;sx duration approx 6hr;									Y	10/09/1998	10/09/1998	0	NOen	PUB	PUB	NONE	NONE	sjogren's synd	NONE~ ()~~~In patient	VA98064	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Malaise; Nausea; Pyrexia; Tachycardia	FLU3~PFIZER\WYETH~4988212~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~454957~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0115054	10/19/1998	MA	83.0	82		M	10/14/1998	pt recv vax & approx 30min post vax pt collapsed @ home brought to hosp & pronounced DOA;	Y	10/08/1998							N	10/08/1998	10/08/1998	0		PUB	PUB	unk	unk	NKDA or other allergies;	~ ()~~~In patient	U199800624	1						1	Unevaluable event; Unevaluable event	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0975790~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0115054	10/19/1998	MA	83.0	82		M	10/09/1998	no adverse events observed @ flu clinic;hosp reported pt recv vax & approx 30min post vax collapsed @ home brought to hosp & pronounced DOA:	Y	10/08/1998		Y					N	10/08/1998	10/08/1998	0		PUB	PUB	unk	unk	NKDA or other allergies	unk~ ()~~~In patient	MA9809	1						2	Unevaluable event; Unevaluable event	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0975790~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0115071	10/19/1998	OK	30.0	30		F	10/15/1998	pt is 3mo pregnant;pt felt faint w/in 2min of vax & was still in area;face flushed;ice pack applied to inj site w/1 redness, progressing to 2 1/2 redness diameter;c/o itching & redness upper chest, upper back & lower back;dec redness				Y					Y	10/13/1998	10/13/1998	0	NONE	OTH	PVT	unk	NONE	pregnancy	unk~ ()~~~In patient		1						1	Dizziness; Pruritus; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0971890~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0115076	10/19/1998	PA	49.0	49		F	10/12/1998	pt recv vax 9OCT98 10AM;noticed sore throat & throat swelling 4PM;took DPH but sx returned 1130PM;went to ER also had some diff swallowing;no diff breathing, no hx of similar problems;treated w/DPH, dexameth,  pepcid;				Y					Y	10/09/1998	10/09/1998	0		OTH	OTH	NONE		sulfa-hives, hx of asthma	~ ()~~~In patient		1						1	Dysphagia; Laryngospasm; Pharyngitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0115081	10/19/1998	NY	32.0	32		F	10/16/1998	itchy hives all over body;									N	10/09/1998	10/09/1998	0		PUB	UNK		NONE	NONE	~ ()~~~In patient		1						1	Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115083	10/19/1998	WI	42.0	42		F	10/09/1998	shortly p/vax felt lightheaded & had a cold rush from head to toes;the next morning ears itched & burned;then got hives all over body;took DPH & MD prescribed methyprednisdone;									Y	10/06/1998	10/06/1998	0	NA	OTH	PVT	NA	NONE	maybe allergic to amocicillan	~ ()~~~In patient		1						1	Chills; Dizziness; Ear pain; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115090	10/19/1998	NV	33.0	33		F	10/15/1998	24hr p/vax devel fine rash on lower arms & face w/itching;itching relieved by PO DPH:									Y	10/13/1998	10/14/1998	1	NONE	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Pruritus; Rash	FLU3~PFIZER\WYETH~4988200~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0115093	10/19/1998	HI	35.0	35		F	10/09/1998	redness w/hardened lump 6cm x 2cm lt arm lasted 3 days;									Y	10/06/1998	10/06/1998	0	NONe	PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Skin nodule; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0971880~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115094	10/19/1998	MO	45.0	45		F	10/13/1998	became hot to touch about 12min p/vax;face flushed, red splotches on shoulders, face, neck & back;not raised;sl tightness in chest-no diff breathing;some nausea no vomiting;observed for about 1 1/2hr & felt better;									Y	10/07/1998	10/07/1998	0	NA	UNK	PVT	NONE	NONE	allergic to pollen, mold, trees per client	NA~ ()~~~In patient		1						1	Chest pain; Dizziness; Nausea; Rash maculo-papular; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20208HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0115096	10/19/1998	LA	78.0	78		F	10/14/1998	backache, h/a, chills w/fever which fever lasted until next day till about 5PM;weakness till mid-afternoon second day then OK again;									Y	10/06/1998	10/06/1998	0		PUB	UNK				~ ()~~~In patient		1						1	Asthenia; Back pain; Headache; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115099	10/19/1998	MI	35.0	35		F	10/15/1998	hives p/24hr started w/knees up to face & eyes (pt treated self w/DPH);									Y	10/07/1998	10/08/1998	1	NONE	PUB	UNK	Pred	chrones disease	NONE	NONE~ ()~~~In patient		1						1	Urticaria	FLU3~PFIZER\WYETH~4988204~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0115100	10/19/1998	FL	78.0	78		M	10/15/1998	no strength, general weakness, bad taste in mouth;									U	10/08/1998	10/10/1998	2		OTH	UNK	Naddol;Corgard			~ ()~~~In patient		1						1	Asthenia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115101	10/19/1998	FL	77.0	77		F	10/15/1998	terrible stomachache, loss of appetite, cough, flu like sx, aches & pain, dryness of mouth, loss strength;bad taste in mouth;									U	10/08/1998	10/10/1998	2		OTH	UNK	Florin			~ ()~~~In patient		1						1	Abdominal pain; Anorexia; Asthenia; Cough; Dry mouth; Influenza; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115103	10/19/1998	NY	88.0	88		F	10/14/1998	large erythematous/edematous area;poss cellulitis;									Y	10/12/1998	10/13/1998	1		PVT	OTH	NONE	NONE	nONE	~ ()~~~In patient		1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema	FLUX~UNKNOWN MANUFACTURER~0977180~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~456689~1~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0115106	10/19/1998	WA	46.0	46		M	10/07/1998	6hr p/vax pt devel fever, chills & sweats episode followed by noc axillary adenopathy;the next morning 20hr later erythema & edema 5mm below inj site;									Y	10/06/1998	10/06/1998	0	NA	PVT	PVT	allegra D;	NONE	hayfever	~ ()~~~In patient		1						1	Hyperhidrosis; Injection site hypersensitivity; Injection site oedema; Lymphadenopathy; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0977210~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1542E~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0115113	10/20/1998	WI	69.0	68		M	10/16/1998	acute onset shaking rigors, diaphoresis, weakness & lt arm pain-adm to r/o MI which was negative;vaccine rxn suspected;				Y	Y	1			Y	10/12/1998	10/13/1998	1	EKG no changes,cardiac troponin enzymes negative;	PVT	UNK	Amitryptiline;Darvocet	NONE	no allergies, no birth defects, prev MI	~ ()~~~In patient		1						1	Asthenia; Chills; Hyperhidrosis; Pain; Tremor	FLU3~PARKDALE PHARMACEUTICALS~02198P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0115115	10/20/1998	NJ	88.0	88		F	10/14/1998	immed upon completion of vax local swelling @ site of vax on the lt deltoid;w/in 3-4min RN gave epi;vital signs were taken BP 188/94, pulse 88;vitals repeated in 5min BP 200/100, pulse 84;911 called;02 via nasal cannula;									U	10/14/1998	10/14/1998	0		PUB	PVT		NA	NA	~ ()~~~In patient		1						1	Hypertension; Hypoxia; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~0983290~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115116	10/20/1998	OR	24.0	24		F	10/08/1998	woke up morning p/vax w/hard breathing, gasping for air, feeling nauseated & uncomfortable;was seen @ clinic & given 2 APAP;sx subsided w/each passing hr;pt can & has eaten eggs;				Y					Y	10/07/1998	10/08/1998	1		OTH	OTH	health care organization	NONE	NONE	~ ()~~~In patient		1						1	Dyspnoea; Malaise; Nausea	FLU3~PFIZER\WYETH~4988199~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0115121	10/20/1998	OR	74.0	74		F	10/13/1998	red, swollen, painful rt upper anterior arm, a few hr p/vax;vax given tx w/ATB, DPH, & cold packs;				Y					U	10/12/1998	10/12/1998	0	NA	PVT	PVT	Premarin, Toprol, ASA, Ditropan, Claritin,Antivert	NA	allergic NSAIS, Cipro	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0967030~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1508E~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0115122	10/20/1998	CA	48.0	48		F	10/14/1998	sl sore throat on 10OCT98;felt worse on 11OCT98;on 12OCT98 felt like had full blown case of flu;aches & pain, watery eyes, h/a, cough, sore throat, extreme fatigue, T100;				Y					Y	10/09/1998	10/10/1998	1	NONe	PVT	OTH	Estrogen	NONE		pt exp 12hr cold @ 47yr old w/flu vax dose 1;~ ()~~~In patient		1						1	Asthenia; Cough; Headache; Influenza; Lacrimal disorder; Myalgia; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0978490~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0115124	10/20/1998	MO	70.0	70		M	10/14/1998	shoulder pain;med given;				Y						10/14/1998	10/14/1998	0		PUB	PUB				~ ()~~~In patient	MO98093	1						1	Arthralgia	FLU3~CONNAUGHT LABORATORIES~0978660~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1246H~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0115128	10/20/1998	OR	32.0	32		F	10/14/1998	pt felt funny, hot, while sitting @ work site 5min p/vax lt arm started itching w/red spots on lt arm, no SOB or throat swelling;									Y	10/14/1998	10/14/1998	0		OTH	UNK	NONE	NONE	vicodan	~ ()~~~In patient		1						1	Malaise; Pruritus; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4988199~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0115131	10/20/1998	MD	23.0	23		M	10/16/1998	pt recv vax 14OCT98 1130AM & noticed soreness hr p/vax & noted redness following evening;the redness & local tenderness has persisted today;takes motrin for other reasons;									N	10/14/1998	10/15/1998	1		PUB	UNK		NONE	hay fever spring time	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Myalgia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115133	10/20/1998	UT	25.0	25		M	10/08/1998	pt devel mouth droop 4 days p/vax;couldn't close eye, face numb, dry rt eye;no pain;dx bells palsy;residual neuro deficit, facial droop & incomplete eye closure;									N	11/05/1997				PVT	UNK		cystic fibrosis	cyotic fibrosis	NONE~ ()~~~In patient		1						1	Dry eye; Facial palsy; Hypertonia; Neuropathy; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~7F81828~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115134	10/20/1998	CA	60.0	60		F	10/14/1998	pt recv vax OCT98 & 9OCT98 c/o back lt muscle soreness;19OCT98 every vertebra in back hurt. In retro-spect - May have been a co-Medicine and not a vaccine reaction									Y	10/02/1998	10/07/1998	5		OTH	PVT						1						1	Arthralgia; Back pain; Myalgia	FLU3~CONNAUGHT LABORATORIES~0980550~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115146	10/21/1998	MO	46.0	46		F	10/14/1998	10min p/vax c/o funny feeling that started in chest 7 went to my stomach;was clammy, warm, shaky, SOB, BP 140/90;assessed in systemic allergic rxn & Epi given;hosp for cardiac eval;					Y	4			Y	10/10/1998	10/10/1998	0	NA	PUB	PVT	NONE	NONE	PCN;Codeine	NONE~ ()~~~In patient		1						1	Chest pain; Chills; Dyspnoea; Hyperhidrosis; Hypersensitivity; Hypertension; Tremor; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20208HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0115150	10/21/1998	MA	67.0	67		F	10/09/1998	3OCT98 9AM pt recv vax & 5PM noticed red, warm area @ site;5OCT98 area had become bruised;pt was febrile & saw MD;rx med;				Y					Y	10/03/1998	10/03/1998	0		PUB	PUB	Dyazide daily	NONE	HTN	~ ()~~~In patient	MA9810	1						1	Ecchymosis; Injection site hypersensitivity; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0304H~2~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0115152	10/21/1998	CA	56.0	56		F	10/12/1998	pt recv vax & immed went to restroom to void-came out 3-5min later wheezing, c/o diff breathing-02 sate 98-99, HR 98, Bp 150/100 given breathing tx & med;pt had some URI sx prior;				Y					Y	10/12/1998	10/12/1998	0		PVT	OTH	Atenolol;Verapamil;Paxil B	mild URI sx	COPD, prior hx of bronchospasm;	NA~ ()~~~In patient		1						1	Asthma; Dyspnoea; Hypertension; Hypoxia; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E20228KA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0115161	10/21/1998	VT	61.0	61		M	10/14/1998	ringing ears, sore throat, malaise, elevated temp;									Y	10/07/1998	10/08/1998	1		PVT	PVT				~ ()~~~In patient	VT98002	1						1	Malaise; Pharyngitis; Pyrexia; Tinnitus	FLU3~PFIZER\WYETH~4988203~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0115165	10/21/1998	WI	12.0			F	10/19/1998	area of 3x5 swollen & warm around inj site;										10/16/1998	10/17/1998	1	NONE	UNK	UNK			asthma;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~498822~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0115166	10/21/1998	PA	57.0			M		pt recv vax 16OCT98 & 17OCT98 pt had to be taken to ER for Bells Palsy facial paralysis;														UNK	UNK			diabetes, HTN, NK addictions, NKDA:	~ ()~~~In patient		1						1	Facial palsy	FLU3~PFIZER\WYETH~4988212~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0115168	10/21/1998	GA	53.0	53		M	10/19/1998	fine papular eruption enter aspects for arms-pruritic, began 5hr p/inj;no other sx;									Y	10/15/1998	10/15/1998	0	NA	OTH	UNK	Zyrtec	NONE	allergic rhinitis	~ ()~~~In patient		1						1	Pruritus; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~0980570~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115177	10/22/1998	PA	66.0	66		M	10/19/1998	sore arm;chills, sweating, chest/heart pains nitro twice;ASA also given;									Y	10/06/1998	10/06/1998	0		PUB	OTH	NONE	NONE prior to vax;	high blood pressure-heart condition	~ ()~~~In patient		1						1	Chest pain; Chills; Hyperhidrosis; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115183	10/22/1998	VA	43.0	42		F	10/13/1998	immed itching @ site w/accompanying c/o dry mouth/dizziness/sensation feeling hot;BP 102/64;AP 64 sit pinkish in color per family MD was called 14min p/initial c/o instructed epi;									Y	10/08/1998	10/08/1998	0	NONE	OTH	PVT	Estioatest tabe;APAP PRN	was not ill	NONE	NA~ ()~~~In patient	VA98065	1						1	Dizziness; Dry mouth; Hypotension; Pruritus; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~03088P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0115185	10/23/1998	VA	53.0	53		M	10/15/1998	upon withdrawal of needle from administering;pt rt deltoid was noted to begin swelling;pressure & bandaid were applied w/swelling of inj site;swelling approx size of a quarter;									Y	10/15/1998	10/15/1998	0		PUB	PUB		NONE	NONE	~ ()~~~In patient	VA98066	1						1	Injection site oedema	FLU3~PFIZER\WYETH~4988212~5~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0115195	10/23/1998	UT	77.0			M	11/21/1997	rash, large blister, necrosis;RN found that pt had rxn approx 2wk p/vax;pt sent to clinic for eval;				Y							10/30/1997			UNK	UNK				~ ()~~~In patient		1						1	Dermatitis bullous; Necrosis; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0115201	10/23/1998	MA	77.0	76		F	10/21/1998	hard above elbow in afternoon;denies redness, warmth;pain increased in evening radiating to back & neck;ER visit 10PM;				Y					U	10/20/1998	10/20/1998	0	NONE	OTH	PVT	Synthroid;Procardia		hypothyroidism, ?arrythmia, CA colon	~ ()~~~In patient		1						1	Back pain; Injection site mass; Neck pain; Pain	FLU3~PARKDALE PHARMACEUTICALS~02988P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~451796~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0115203	10/23/1998	TN	41.0	41		F	10/16/1998	erythematous, urticarial rash on chest & neck around 30-45 p/vax;				Y					Y	10/15/1998	10/15/1998	0	NONE	UNK	PVT	SYnthroid;Orthocycline BCP	NONE	environmental allergies	NONE~ ()~~~In patient		1						1	Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~0981850~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0115204	10/23/1998	WI	36.0	36		F	10/20/1998	urticaria, minimal secondary hypersensitivity rxn;hives on face, arms, flushed, felt warm;				Y					Y	10/19/1998	10/19/1998	0	NONE	OTH	UNK	Paxil, Trazodore, Thorazine, DOxycycline, Prilosec	NONE	allergy-sulfa & amoxocillin	~ ()~~~In patient		1						1	Hypersensitivity; Urticaria; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20228KC~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0115205	10/23/1998	OR	5.0	5		F	10/16/1998	pt recv vax 14OCT98 & 15OCT devel significant red, warm, indurated area of upper arm (10x7cm);				Y					U	10/14/1998	10/15/1998	1	referred to allergist;	PVT	UNK	NONE	NONE	asthma	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0981790~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0115206	10/23/1998	PA	57.0	57		M	10/20/1998	dx Bell's Palsy, facial paralysis, swelling;				Y					N	10/16/1998	10/18/1998	2		PUB	PVT		NONE	diabetes-HTN	~ ()~~~In patient		1						1	Facial palsy; Oedema	FLU3~PFIZER\WYETH~4988212~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0115212	10/23/1998	FL	65.0	65		F	10/19/1998	sx started 16OCT98 fever & swelling in hands, face, throat cont until 17OCT98 afternoon;had diff breathing w/o sitting up;sometimes swollen feeling in throat w/some nasal-face burned;joint pain;									Y	10/15/1998	10/16/1998	1	NONE	PUB	UNK		NONE	NONE	NONE~ ()~~~In patient	FL98052	1						1	Arthralgia; Dyspnoea; Laryngospasm; Oedema peripheral; Pain; Pyrexia; Rhinitis	FLU3~PARKDALE PHARMACEUTICALS~E20208A2~4~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0115214	10/23/1998	MN	34.0	34		F	10/21/1998	pt states exp throat tightening 20min p/vax;sx lasted 5-7min, per pt & then resolved;pt was @ home, no tx x/advised to take DPH;pt called clinic p/sx had resolved;									Y	10/16/1998	10/16/1998	0	NONE	PVT	PVT	Inhalers	NONE	bee sting, allergy-throat closing rxn in past, allergies, asthma	~ ()~~~In patient		1						1	Laryngospasm	FLU3~PARKDALE PHARMACEUTICALS~01998P~2~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0115215	10/23/1998	CO	37.0	37		F	10/21/1998	increasing @ site of pneumococcal vax lt arm muscle soreness, rash, swollen @ inj site;underarm (lymph nodes);can't raise arm completely;possible fever last evening;									U	10/19/1998	10/19/1998	0		UNK	UNK			healthy, noncontributory til now;husband has CF;	~ ()~~~In patient		1						1	Hypokinesia; Injection site oedema; Lymphadenopathy; Myalgia; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~~UNK~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0115216	10/23/1998	MA	63.0	63		F	10/19/1998	redness, swelling, warmness @ site of inj devel 3 days post vax;? cellulitis lt upper arm;									Y	10/14/1998	10/17/1998	3		PVT	PUB		NONE	HTN, asthma, abd hernia, obesity	~ ()~~~In patient		1						1	Cellulitis; Injection site hypersensitivity; Oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975780~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0906E~UNK~~RA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~0923910~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0115217	10/23/1998	MN	74.0	74		M	10/16/1998	9-5cm area of erythema w/2cm central area of necrosis/ulceration;									U	10/07/1998	10/15/1998	8	NONE	PVT	PVT		NONE	diabetes, CAD	~ ()~~~In patient		1						1	Rash; Skin necrosis; Skin ulcer	FLU3~PARKDALE PHARMACEUTICALS~01998P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0115218	10/23/1998	MA	50.0	50		F	10/21/1998	pt recv vax & exp blisters in the mouth, swollen tongue & lips;encouraged to notify MD;									Y	10/20/1998	10/20/1998	0	NONe	PUB	PUB		NONE	NONE	NONE~ ()~~~In patient	MA9812	1						1	Face oedema; Stomatitis; Tongue oedema	FLU3~CONNAUGHT LABORATORIES~975790~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115221	10/23/1998	CO	51.0	51		F	10/20/1998	soreness @ site, immed p/vax;no fever, but extreme muscle aches & soreness for 1 wk;no diff w/breathing but throat feels weird as if chocking;									Y	10/13/1998	10/13/1998	0	NONE	PUB	PVT	NONE	NONE	NONE disk problems;	NONE~ ()~~~In patient		1						1	Injection site pain; Laryngospasm; Myalgia; Pain	FLU3~PFIZER\WYETH~4988216~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0114731	10/26/1998	AL	47.0	47		F	10/02/1998	numbness in body-dizzy, extreme weakness, hard to walk, pain: inflammation in brain & spinal cord;no cure;only tx is steroids;had immed pain in arm for 2wk;transverse myelitis;					Y	5		Y	N	11/12/1997	03/01/1998	109		OTH	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						2	Anorexia; Asthenia; Delirium; Depressed level of consciousness; Diarrhoea; Dizziness; Hypokinesia; Myelitis; Neuropathy; Paraesthesia; Asthenia; Delirium; Depressed level of consciousness; Dizziness; Hypokinesia; Myelitis; Pain; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E20067KF~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~E20067KF~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation,Disabling	Influenza
0115255	10/26/1998	KY	83.0	82		M	10/20/1998	pt recv vax 13OCT98 & 14OCT98 pt committed suicide gun shot wound to head;	Y	10/14/1998							N	10/13/1998	10/14/1998	1		UNK	UNK				~ ()~~~In patient	U199800667	1						1	Unevaluable event	FLU3~CONNAUGHT LABORATORIES~0981800~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0115260	10/26/1998	MA	77.0	77		M	10/23/1998	c/o vague sx of not feeling well;T102.4;	Y	10/22/1998			Y	2			N	10/21/1998	10/22/1998	1	T102.4;	OTH	OTH			ESRD, HTN	~ ()~~~In patient		1						1	Malaise; Pyrexia; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0975790~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0115264	10/26/1998	WI	58.0	58		F	10/19/1998	pt recv vax 10AM 14OCT98 & 11AM had pain to let side of head, dec jaw & to lt side of neck;woke up 4AM 15OCT98 had diff w/gait (couldn't put lt leg forward);also c/o weakness to lt arm & hand;diff making tea;lt leg/knee still weak;				Y	Y	3			N	10/14/1998	10/14/1998	0	2 CAT scans-both negative;	PUB	UNK	NONE	NONE	migraine & back injury	~ ()~~~In patient		1						1	Gait disturbance; Headache; Hypokinesia; Myasthenic syndrome; Neck pain; Pain	FLU3~PFIZER\WYETH~4988222~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0115266	10/26/1998	IN	51.0	51		F	10/18/1998	immed post vax pt exp redness, itching, swelling, joint pain, went to bed during day (unusual) fever, does not feel well,hoarseness, wheezing, hives, weakness;			Y						N	10/15/1998	10/15/1998	0	NONE	OTH	UNK	44 pills daily numerous meds		fibromyalgia, MS hx arthritis	pt exp redness, swelling, joint pain, fever, hives, weakness, not well w/flu vax~ ()~~~In patient		1						1	Arthralgia; Asthenia; Asthma; Pharyngitis; Pruritus; Pyrexia; Somnolence; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0115267	10/26/1998	NV	53.0	53		F	10/17/1998	sx-trouble breathing, sore throat, coughing, mucous, chills, fever, diarrhea, vomit, head pain, neck pain, abd pain, leg pain, trouble walking, agitation;			Y						Y	10/14/1998	10/14/1998	0	NONE	OTH	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Cough; Diarrhoea; Dyspnoea; Hypokinesia; Neck pain; Pharyngitis; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~0984620~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0115269	10/26/1998	NY	85.0	85		F	10/21/1998	c/o weakness w/some pain & swelling in joints;pt presented to ER 18OCT98 & was adm for weakness etiology unk;elevated WBC 47,000, no fever,abd bloating & workup was started;					Y	8			U	10/12/1998	10/13/1998	1	cardiac enzymes, CBC, chem 6, UA, urine & blood cult, ECG, CXR;	PVT	PVT	Ditropan;Evista;Arthotec;Lotrel;Propulsid;Lasix;Levotab;Claritin;Proventil;Vanceril;APAP	sinusitis, SOB, low back pain	HTN, COPD, CHF, sinusitis, FBD, diverticulitis, osteoarthritis;	~ ()~~~In patient		1						1	Arthralgia; Arthritis; Asthenia; Flatulence; Leukocytosis; Myasthenic syndrome; Osteoarthritis; Sepsis; Arthralgia; Arthritis; Asthenia; Myalgia; Sepsis	FLU3~CONNAUGHT LABORATORIES~0981800~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0981800~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0115276	10/26/1998	CO	39.0	39		M	10/19/1998	c/o SOB, severe chest pain, pt skin was clammy & pale;pt c/o feeling faint approx 30min p/vax;911 called epi given;				Y					Y	10/14/1998	10/14/1998	0		OTH	OTH	Depakote	NONE	epilepsy-controlled	~ ()~~~In patient		1						1	Chest pain; Dizziness; Dyspnoea; Hyperhidrosis; Pallor	FLU3~MEDEVA PHARMA, LTD.~E20118GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0115280	10/26/1998	NC	46.0	46		F	10/14/1998	pt recv vax 1230PM 14OCT98 & pt reported itching & redness in a hive formation below site;reported feeling light headed & nervous w/a very sl feeling of SOB;given epi;vs BP 146/86, R22, P88;pt reported sx improved but still c/o lightheaded				Y					Y	10/14/1998	10/14/1998	0		OTH	PVT	NONE		allergic to ocntrast dye, codeine, pain relievers	~ ()~~~In patient		1						1	Dizziness; Dyspnoea; Hypertension; Hyperventilation; Injection site hypersensitivity; Nervousness; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~0978660~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0115290	10/26/1998	OR	73.0	72		F	10/19/1998	deep erythema, swelling, pain, elbow to shoulder rt side, nausea/diarrhea;				Y					Y	10/14/1998	10/16/1998	2	NONE	PVT	PVT		NONE		~ ()~~~In patient		1						1	Diarrhoea; Injection site pain; Nausea; Oedema; Rash	FLU3~CONNAUGHT LABORATORIES~0980550~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454960~2~SC~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0115291	10/26/1998	OR	77.0	77		F	10/16/1998	erythema & induration inj site;				Y					Y	10/14/1998	10/15/1998	1	NONE	PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~0980550~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454960~2~SC A~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0115292	10/26/1998	OR	73.0	73		F	10/15/1998	severe local hypersensitivity rxn w/in 2hr of vax;				Y					Y	10/14/1998	10/14/1998	0	NONE	PVT	PVT		NONE		~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~0980550~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454960~2~SC~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0115293	10/26/1998	MI	64.0	64		F		pt recv vax 16OCT98 & awakened day following vax 17OCT98 w/hives on lt thigh size 1-1 1/2 spreading to buttock (lt on 18OCT);painful;T99-99.3;buttock still red raised areas, painful;				Y					N	10/16/1998	10/17/1998	1		PUB	PUB	theophyline;Covera;Provasid;Pred;	copd;C-defical	rash w/minocin;COPD;	~ ()~~~In patient	MI98122	1						1	Myalgia; Pain; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0965760~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0115294	10/26/1998	PA	46.0	46		M	10/19/1998	dysuria, generalized myalgia, arthralgias, fever, chills & nausea;				Y					N	10/16/1998	10/17/1998	1	UA abnormal;	OTH	UNK	Zocor;Pepcid;Flonase;ASA	NONe	CAD, GERD	~ ()~~~In patient		1						1	Arthralgia; Dysuria; Myalgia; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0115297	10/26/1998	PA	42.0	42		M	10/22/1998	could not move lt arm, sweating profusely, T102, chills, aches, pains, could not sleep, inj item sore w/hard not;cont w/T100-102, chills, body aches;				Y					N	10/20/1998	10/21/1998	1	NONe	OTH	OTH	high BP med;Buspar	NONE	NONE	~ ()~~~In patient		1						1	Hyperhidrosis; Hypokinesia; Injection site mass; Injection site pain; Insomnia; Myalgia; Pyrexia; Hypertonia; Hypokinesia; Malaise; Oedema peripheral; Pyrexia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~MEDEVA PHARMA, LTD.~E20088FE~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0115298	10/26/1998	IA	30.0	30		F	10/23/1998	hives, red blotches, small blotches-size of quarter & 1/2 dollar on face & arms;				Y					N	10/15/1998	10/16/1998	1	NONE	PUB	PUB	Prevasid;Zoloft;Trazadil	mild respcold	codeine;morphine;	~ ()~~~In patient		1						1	Rash maculo-papular; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0115299	10/26/1998	NY	70.0	70		F	10/16/1998	dizzy, feeling bad, sick, sick to stomach, dry heaves, sweating, chills, intermittently, weakness;dx cleaned ears;				Y					N	10/05/1998	10/12/1998	7	BP 110/60, oxy 95;	OTH	OTH	baby ASA;Prilos	NONE	NONE	pt exp sick x 2 yr in a row 1960 w/flu vax;~ ()~~~In patient		1						1	Chills; Dizziness; Dyspepsia; Hyperhidrosis; Hypotension; Hypoxia; Malaise; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0115300	10/26/1998	NY	2.0	2	.1	F	10/19/1998	swelling of lt arm from waist to above shoulder & extending over to lt scapula-tenderness on palpation not indurated, sl erythema;no streaking;				Y					Y	10/14/1998	10/15/1998	1	NONE	PVT	PVT	Chromolin;Albuterol		reactive airway disease;	~ ()~~~In patient		1						1	Injection site oedema; Oedema; Oedema peripheral; Pain; Rash	FLU3~CONNAUGHT LABORATORIES~0968380~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0115302	10/26/1998	CT	67.0	67		F	10/23/1998	pt exp redness, pain, & heat & site;seen 22OCT95 @ health center dx cellulitis secondary to vax;				Y					Y	10/20/1998	10/20/1998	0		PUB	PUB		NONE		NA~ ()~~~In patient	CT9806	1						1	Cellulitis; Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~20138GB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0871H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0115303	10/26/1998	CA	50.0	50		F	10/23/1998	muscle weakness & chronic pain in muscles, around joint increased drastically;walking is extremely painful;uses a cane;became unable to walk from 1993 to 1998;h/a, swelling;becoming paralyzed;sz;SEP98 myositis, myalgia w/radiculitis;				Y					N	10/02/1992				PUB	OTH	Tenex (BP)	inc titre of epstein-Barr >1000 & temp elevated secondary sinus/ear infect	chronic fatiuge (CFIDS), chronic muscle pain (long standing x yrs);fibromyalgia;chronic ear infect;diabetes type II;GBS 1945;mom paralyzed on lt side x several months;	pt exp bronchitis productive x 3 days @ 50yr old w/flu, pneumonia vax;~ ()~~~In patient		1						1	Arthropathy; Back pain; Convulsion; Hypokinesia; Myalgia; Myasthenic syndrome; Myositis; Paralysis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0115304	10/26/1998	CA	73.0	73		F	10/20/1998	quarter size local pruritic, erythema, rxn lt deltoid to flu vax;									Y	10/20/1998	10/20/1998	0	no test administered or indicated;	MIL	MIL	no known medications	NONE	NONE	~ ()~~~In patient		1						1	Pruritus	FLU3~MEDEVA PHARMA, LTD.~E20098GB~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0115306	10/26/1998	ME	71.0	71		M	10/19/1998	woke up @ 130PM 9OCT98 walked to bathroom then collapsed on floor came to moments later arm swollen-shoulder to elbow, warm, bright red did not call 911 or MD no problems since;									Y	10/08/1998	10/09/1998	1	NONE	PUB	PUB	Bufferin	NONE	bladder Ca	NONE~ ()~~~In patient	MA9813	1						1	Oedema peripheral; Syncope; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975790~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0304Y~1~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0115309	10/26/1998	MI	62.0	62		U	10/20/1998	2hr p/vax chills & fever ?temp, weakness, urine turned orange; next day felt better;Sunday devel cold sore & swelling & rash on lt side face & tenderness in neck;redness @ site;blood sugar 288;										10/15/1998	10/15/1998	0	NONe	PUB	UNK	Clariton;Tenormin	NONE	allergies-dust	pt sibling devel flu, ?sick~ ()~~~In Sibling		1						1	Asthenia; Face oedema; Hyperglycaemia; Injection site hypersensitivity; Mouth ulceration; Neck pain; Pyrexia; Rash	FLU3~PFIZER\WYETH~4988204~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0304H~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0115314	10/26/1998	CO	27.0	27		F	10/21/1998	onset 30min post vax of gen itching, tingling, anxiety w/feeling of being spacey;no rash or SOB;									Y	10/21/1998	10/21/1998	0		OTH	PVT			NONE	~ ()~~~In patient		1						1	Anxiety; Paraesthesia; Pruritus; Thinking abnormal	FLU3~CONNAUGHT LABORATORIES~0973970~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115315	10/26/1998	OH	79.0	78		F	10/17/1998	pains from shoulder to shoulder (soreness);									N	10/13/1998	10/15/1998	2	NONE	OTH	PUB	Zanax;Sorbite circulation pills	NONE	high BP, resp problems	~ ()~~~In patient		1						1	Back pain; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115316	10/26/1998	PA	7.0	7		M	10/16/1998	broke out in hives on lt buttock & lt upper thigh;rx DPH;									Y	10/16/1998	10/16/1998	0	NONE	UNK	UNK				~ ()~~~In patient		1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115317	10/26/1998	NJ	65.0	65		F	10/15/1998	swelled, hot, rx DPH, from shoulder to elbow rt arm, painful;									N	10/15/1998	10/15/1998	0	NONE	PUB	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~0978660~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0115318	10/26/1998	TX	53.0	53		F	10/16/1998	7hr post vax chills, temp, body shivering out of control, minor sore throat, severe h/a, generalized body aches & pains;									N	10/15/1998	10/16/1998	1	NONe	OTH	OTH	Paxil, Azicol, hormone replacement therapy	NONE	collitis	~ ()~~~In patient		1						1	Headache; Myalgia; Pharyngitis; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115319	10/26/1998	OH	43.0	43		M	10/23/1998	h/a, fever, eyes, face, cheek warm & hurting lot of pressure on eyes, h/a severe;										10/22/1998	10/22/1998	0		UNK	UNK				~ ()~~~In patient		1						1	Conjunctivitis; Eye pain; Headache; Pain; Pyrexia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115321	10/26/1998	IL	49.0	49		F	10/21/1998	rt arm @ inj is rock hard, chills, body aches, sore throat, weakness, hoarseness, dizziness;									N	10/20/1998	10/20/1998	0	NONE	OTH	OTH	neclazine;thyroid	NONE	inner ear problems;sulfa, PCN	~ ()~~~In patient		1						1	Asthenia; Chills; Dizziness; Injection site mass; Myalgia; Pharyngitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115323	10/26/1998	TN	40.0	40		F	10/24/1998	bright red rash on nose following vax (raised)									N	10/20/1998	10/20/1998	0	NONE	PUB	PUB	NONE	NONE	bee sting allergy hypersensitivity to decongestant;	~ ()~~~In patient		1						1	Rash maculo-papular; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115324	10/26/1998	NC	68.0	68		F	10/21/1998	congestion, blood in sputum, aches;									N	10/12/1998	10/19/1998	7	NONE	OTH	OTH	vitamins	NONE	allergies	~ ()~~~In patient		1						1	Haemoptysis; Myalgia; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115325	10/26/1998	WA	43.0	43		F	10/19/1998	severe itching on bottom of feet-hives on back, red circle & arm sore @ inj site 5hr post vax;									Y	10/17/1998	10/17/1998	0	NONE	PVT	OTH	asthmacort inhaler	NONE	welbutrin 1wk prior to vax	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115327	10/26/1998	NY	45.0	45		F	10/21/1998	c/o local swelling & redness, h/a, dry mouth;pt presented to MD office & was eval;BP 182/108, had h/a;									N	10/21/1998	10/21/1998	0		PVT	PVT	Prevacid;Accupril;Prempro;Colace;propulsid;	NONE	GERD, IBS, HTN	NA~ ()~~~In patient		1						1	Dry mouth; Headache; Hypertension; Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~0981800~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115331	10/26/1998		60.0	60		U		T97.1, BP 130/80, c/o cough, SOB since 15OCT98, head congestion awoke 15OCT98 feeling of rt upper arm being burned, very sore w/multiple red blotches from inj site of vax up to rt neck;felt like being pinched;sl wheeze w/forced expiration									Y	10/14/1998	10/15/1998	1		PVT	UNK		sinusitis, bronchitis w/bronchospasm	NONE	NA~ ()~~~In patient		1						1	Asthma; Cough; Dyspnoea; Hypertension; Hypothermia; Injection site hypersensitivity; Injection site pain; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0967040~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0304H~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0115332	10/26/1998	NY	38.0	38		F	10/21/1998	1/2hr arm pain;2hr p/shot dizzy, lethargic;5hr p/shot body aches & chills;									U	10/20/1998	10/20/1998	0	NONE	PUB	UNK		NONE	NONE	pt mom exp same rxn 2wk ago w/flu vax;~ ()~~~In patient		1						1	Chills; Dizziness; Myalgia; Pain; Somnolence	FLU3~MEDEVA PHARMA, LTD.~E20228KB~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0115333	10/26/1998	IA	62.0	62		F	10/23/1998	rt upper arm swollen, warm, sl reddened;got shot pneumonia 22OCT98 rt arm 1PM;									Y	10/22/1998	10/22/1998	0	NONE	PUB	PUB	NA	NONE	NONE	NA~ ()~~~In patient	IA98029	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0115335	10/26/1998	HI	39.0	39		F	10/19/1998	on 3rd day post vax 2x3 hard, red, itchy area;hot to touch x 2-3 days;									Y	09/23/1998	09/26/1998	3	NONE	MIL	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975790~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115336	10/26/1998	HI	43.0	43		F	10/06/1998	woke up next day feeling very congested, & achy;as day progressed, felt worse/more achy, sore neck & sore rt arm;rt hand sl swollen, hot, diaphoretic, fever 100.4;inc aches, wheezy chest;									Y	10/03/1998	10/04/1998	1	NONE	PVT	OTH	Zoloft;Ortho cyclen	poss mild sinusitis	allergy: codeine, sulfa	NONE~ ()~~~In patient		1						1	Asthma; Chest pain; Myalgia; Neck pain; Oedema peripheral; Pyrexia; Rhinitis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0971880~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115337	10/26/1998	IA	62.0	62		F	10/23/1998	pt devel reddened, warm, 4 by 2 area @ inj site about 4-6hr p/vax;site became larger next day;3 days p/vax redness faded;area itching;									Y	10/20/1998	10/20/1998	0	NA	PUB	PUB	BP & asthma	NONE	allergic to erythromycin;has HTN & asthma	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0978720~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~7J91913~7+~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0115338	10/26/1998	VA	44.0	44		F	10/15/1998	Pt recv vax on 10/13/98; on same day pt exp pain &induration in area of vax									Y	10/13/1998	10/13/1998	0	UNK	PUB	OTH	Recv allergy shot 10/12/98; allergy medication	NONE	Allergic to dust, mold, pollens, trees, ragweed; asthma	UNK~ ()~~~In patient	VA98067	1						1	Injection site mass; Injection site pain; Pain	FLU3~PFIZER\WYETH~4988212~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~452374~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0115340	10/26/1998	MD	55.0	55		F	10/20/1998	Pt recv vax on 10/14/98; 20 min later pt exp swelling of LA.									Y	10/14/1998	10/14/1998	0	N/A	PVT	PVT	Prozac, Adipex P, Chromium, Climera, baby ASA	NONE	N/A	N/A~ ()~~~In patient		1						1	Oedema peripheral	FLU3~MEDEVA PHARMA, LTD.~E20248KF~7+~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0115341	10/26/1998	KS	67.0	67		F	10/19/1998	Pt recv vax on 10/13/98; on same day pt exp hot feeling, nausea, vomiting, shakes &weakness.									Y	10/13/1998	10/13/1998	0	N/A	PUB	PUB	UNK	Slightly nauseated	NKMA-taking heart &blood pressure meds; Synthroid-Relan/Tagamt	UNK~ ()~~~In patient		1						1	Asthenia; Condition aggravated; Vasodilatation; Vomiting	FLU3~CONNAUGHT LABORATORIES~0972860~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115344	10/26/1998	MO	62.0	62		F	10/16/1998	Pt recv vax on 10/15/98; on 10/16/98 pt exp redness, warmth, raised, itchy, stinging around injection site &below site.									N	10/15/1998	10/16/1998	1	NONE	PUB	PVT	Delcor, Water pill	NONE	HTN	UNK~ ()~~~In patient	MO98059	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Pruritus; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~0981800~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115365	10/27/1998	MA	51.0	50		F	10/20/1998	15OCT98 7PM flu sx fever, achy, chills, h/a, rash on cheek subsided 17OCT98 & new sx appeared;c/o chest tightness & feeling like someone was sitting on chest;adm for observation & tests 17OCT98 3PM;				Y	Y	3			Y	10/15/1998	10/15/1998	0	stress test-negative cardiac enymes-negative;ECG negative other bloodwork-negative;	PUB	PUB	NONE	NONE	NONE	pt xp flu sx x 3 days @ 34yr old w/flu vax dose 1;~ ()~~~In patient		1						1	Chest pain; Headache; Influenza; Myalgia; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~0975780~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0115368	10/27/1998	MN	65.0	65		F	10/20/1998	1hr p/vax pt exp itching, swelling, burning @ inj site became progressively worse size 100mm x 100mm 24hr later then devel periorbital edema lt eye, lower lip edema & patches of lesions;				Y					Y	10/19/1998	10/19/1998	0		PUB	PVT	NONE	NONE	hayfever	~ ()~~~In patient		1						1	Face oedema; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~01998P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0115373	10/27/1998	TX	48.0	48		F	10/09/1998	2hr p/vax the site became very itchy & red & began to fell nauseated & lightheaded;pt very anxious ;pt slept;				Y						10/07/1998	10/07/1998	0		UNK	UNK		NONE	bee stings/PCN	~ ()~~~In patient		1						1	Anxiety; Dizziness; Injection site hypersensitivity; Nausea; Pruritus; Somnolence	FLU3~CONNAUGHT LABORATORIES~0970170~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0115378	10/27/1998	TN	74.0			M	10/22/1998	about 4-6hr p/vax pt monitored pressure was got strange BP readings, high pulse rate & audible & visual indicators shared a very fast & very irregular heart beat;atrial fibrillation;went to sleep early;										10/14/1998	10/14/1998	0		PUB	PUB	Toren;Vasotec;Thyroid, ASA, Klonopin, Sinemet	NONE	hypothyroid, HTN, vascular system dissease	in 1992 pt exp similar incident p/flu vax;~ ()~~~In patient		1						1	Arrhythmia; Atrial fibrillation; Condition aggravated; Hypotension; Somnolence; Tachycardia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115379	10/27/1998	VA	72.0	72		F	10/21/1998	pt reports 4 days p/vax c/o tenderness, swelling, red, itchy arms, moving from site to elbow;slowly improving using ice & elevation as needed;denies fever but will cont to f/u daily as needed;									Y	10/15/1998	10/15/1998	0	NOEN	PVT	OTH			HTN	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Pruritus	FLU3~PFIZER\WYETH~4988203~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~445637~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0115380	10/27/1998	PA	78.0	77		M	10/23/1998	3AM 17OCT98 arose from sleep to get dressed;became very dizzy, could not stand & fell to the floor;climbed back into bed still dizzy & went to sleep;awoke 2hr later was still unsteady;later it passed off;									Y	10/16/1998	10/17/1998	1		PUB	UNK		NONE	NONE	~ ()~~~In patient		1						1	Dizziness; Hypokinesia; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115381	10/27/1998	TX	47.0	47		F	10/15/1998	14OCT98 c/o cough, sinus & chest congestive w/clear sinus drainage 4hr p/vax;states sclera reddened eyes burning w/h/a & weakness lasting 8hr;states took DPH/aleve x2 3hr apart;sx resolved;									Y	10/14/1998	10/14/1998	0	NONE	PVT	PVT	prilosec;synthroid;DPH;aleve	NONE	hypothyroidism, gastric reflux, degenerative spine dz	~ ()~~~In patient		1						1	Asthenia; Conjunctivitis; Cough; Eye pain; Headache; Lung disorder; Sinusitis	FLU3~PARKDALE PHARMACEUTICALS~02198P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0115382	10/27/1998	UT	52.0	52		F	10/16/1998	pain in the lt arm;ache-throbbing;numb feeling, red, swelling, hot;										10/14/1998	10/15/1998	1	NA	PUB	PUB	estrogen substitue;provera;prozac	NONE	NONE		UT982518	1						1	Myalgia; Oedema; Pain; Paraesthesia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~4988200~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115384	10/27/1998	CA	0.7			M	10/20/1998	rash;fever;irritable;sl lethargy;rx DPH, observe;									U	10/16/1998	10/16/1998	0		OTH	PVT	tri-vi-flor	old OM	NONE	NONE~ ()~~~In patient		1						1	Agitation; Pyrexia; Rash; Somnolence	DTAP~CONNAUGHT LABORATORIES~0942540~3~~RL~DTAP (TRIPEDIA)~1|FLU3~PFIZER\WYETH~4988214~1~~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~SMITHKLINE BEECHAM~2725A2~3~~LL~HEP B (ENGERIX-B)~1	USA		Influenza
0115385	10/27/1998	NJ	36.0	36		M	10/21/1998	pt recv vax 19OCT98 & 20OCT98 430PM began itching, had hives in evening;no angioedema;21OCT98 came to clinic 1205PM mild itching & red welt, rt inner arm;DPH given;									Y	10/19/1998	10/20/1998	1	NONE	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~0980540~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115386	10/27/1998	WA	77.0	77		F		facial swelling w/erythema;papular pruritic rash extending to neck & upper chest;lips swollen;local inflammation @ inj site;									Y	10/14/1998	10/15/1998	1	pt report: probable egg sensitivity from allergy tests;	PVT	PVT	HRT;Lupetar	NONE	multiple pollens	~ ()~~~In patient		1						1	Face oedema; Injection site reaction; Pruritus; Rash; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~0981790~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115388	10/27/1998	ND	62.0			U		sore throat began 3:30 worsened by 4:30, chest started tightening by 5PM-chest wouldn't expand to draw in enough air to breath by 5:15-much vomiting;called for help by 5:30 left for hosp about 5:30-2noc stay;					Y	2			Y	10/09/1998				UNK	UNK	only vitamins & calcium	NONE	NONE	~ ()~~~In patient		1						1	Chest pain; Dyspnoea; Pharyngitis; Respiratory disorder; Vomiting	FLU3~CONNAUGHT LABORATORIES~0977210~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0115392	10/27/1998	NY	49.0	49		F	10/20/1998	evening of day pt vaccine begin to notice  paralysis of rt face;Bell's palsy									N	10/15/1998	10/15/1998	0	NONE needed;	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	FLU88251098	1						1	Facial palsy	FLU3~PARKDALE PHARMACEUTICALS~02198P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0115401	10/28/1998	NE	1.9	1	.9	F	10/23/1998	21OCT98 215PM sz (staring-glazed eyes-brought arms up to chest-very rigid) lasted 10-15min;21OCT98 630PM 10min sz MD called;21OCT98 830PM child adm to hosp another sz (the stary type);22OCT98 9AM short sz in hosp (stary type-tremors of arms					Y				U	10/20/1998	10/21/1998	1	phenobarb level done;CBC upon adm to hosp 21OCT98	UNK	UNK		NONE	sz-unk origin dx @ 9mo of age;allergy to dilantin	~ ()~~~In patient		1						1	Condition aggravated; Convulsion; Hypertonia; Stupor; Tremor	FLU3~CONNAUGHT LABORATORIES~0967030~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1254H~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0115404	10/28/1998	CA	71.0	71		M	10/24/1998	well check-up 11 hr post vax woke w/body in clammy sweat, vomiting, delirious, distressed, entire body in shock, no urine, tremors, semi-convulsive, dizzy-cant not site;can only lay in bed;			Y	Y					N	10/20/1998	10/21/1998	1	test done @ well check prior to vax all nl	PVT	OTH		Paraplegic	spinal cord disease (MS) no deterioration x 15yr;	~ ()~~~In patient		1						1	Cerebrovascular accident; Delirium; Dermatitis exfoliative; Gastrointestinal disorder; Hypertonia; Paralysis; Shock; Speech disorder; Tremor; Urinary retention; Vomiting	FLU3~PFIZER\WYETH~4988207~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening	Influenza
0115405	10/28/1998	OH	27.0	27		F	10/19/1998	cough s/s similar to bronchitis;					Y	4			Y	10/14/1998	10/14/1998	0		PUB	UNK		NONE	sensitive to sprays;hx panic attack;	~ ()~~~In patient		1						1	Bronchitis; Cough	FLU3~CONNAUGHT LABORATORIES~0977170~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0115407	10/28/1998	WI	49.0	49		F	10/26/1998	dx as acute toxic arthritic rxn to vax w/in 4 to 6 hr post vax low back pain began & progressed for next 5 to 7 days w/acute pain to low back & hips, w/fever, chills, treated in ER for severe pain;				Y	Y	1			U	10/17/1998	10/17/1998	0	IVP flatplate of abd;	OTH	OTH	Loestrin	NONE	nONE	~ ()~~~In patient		1						1	Arthralgia; Arthritis; Back pain; Pain; Pyrexia; Arthralgia; Back pain; Chills; Hypokinesia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~MEDEVA PHARMA, LTD.~~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Hospitalisation	Influenza
0115408	10/28/1998	MN	18.0	18		M	10/26/1998	sz post vax x 2 13OCT-14OCT x2 17OCT;			Y	Y	Y	1			Y	10/13/1998	10/13/1998	0	labs normal	PVT	PVT	Propalsid;Inipromene;Sumycin;Benzomycin;albuterol	NONE	hx cerebral palsy-no hx sz, PCN, RAD, acne;	~ ()~~~In patient		1						1	Convulsion	FLU3~PARKDALE PHARMACEUTICALS~01998P~2~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation	Influenza
0115413	10/28/1998	WA	28.0	27		F	10/23/1998	hives, swelling in periorbital area;				Y					Y	10/16/1998	10/16/1998	0		MIL	MIL		NONE	NONE	~ ()~~~In patient		1						1	Face oedema; Urticaria	FLU3~CONNAUGHT LABORATORIES~0968420~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0115414	10/28/1998	WI	10.0	10		M	10/23/1998	fever, cont 2 1/2wk-ranging 101-102.5 6OCT-23OCT;weak, tired;runny nose, ear infect;				Y					N	10/01/1998	10/07/1998	6	strep throat cult negative;	PUB	PVT	NONE	NONE	asthma wheeze w/resp infect	~ ()~~~In patient		1						1	Ear disorder; Infection; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0115415	10/28/1998	NV	66.0	66		F		@ site down arm itched;extremely swollen & red then top of arm to wrists hot & sore;				Y					Y	10/22/1998	10/22/1998	0	NONE	OTH	PUB	slocay;lotensin, premarin, lasix, zocor	NONE	shellfish, tofu, codeine	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Pain; Pruritus; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0115420	10/28/1998	IL	60.0	60		F	10/26/1998	diaphoresis;tiredness;swollen rt arm;redness @ inj site;body aches;									Y	10/19/1998	10/20/1998	1		PVT	PVT	Premarin;Trandate;Zoloft;Imipramine;Prinavil;Tagamet;voltaren	NONE	tetracycline, seldane	~ ()~~~In patient		1						1	Asthenia; Hyperhidrosis; Injection site hypersensitivity; Myalgia; Oedema peripheral	FLU3~PARKDALE PHARMACEUTICALS~02788P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~454954~UNK~SC~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0115421	10/28/1998	NV	41.0	41		F	10/23/1998	arm swelled up;red;warm;itching;									Y	10/17/1998	10/17/1998	0	NONE	OTH	OTH	Synthroid;Estrace	NONE	hasimoto's thyroiditis;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0984620~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115422	10/28/1998	OH	33.0	33		F	10/26/1998	lingering h/a, itchy, nauseated;hot flashed/chills;is functioning fine;									Y	10/20/1998	10/20/1998	0	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	OH98081	1						1	Chills; Headache; Myalgia; Nausea; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975850~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0871H~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0115423	10/28/1998	AR	75.0	75		F	10/20/1998	pt was getting read for bed sitting on toilet must have los consciousness because next awareness was a heavy downward push on chest;pulse was very slow, felt weak afterwards, h/a since;									Y	10/19/1998	10/20/1998	1	will have MRI	OTH	OTH	NA	NA	NA	NA~ ()~~~In patient		1						1	Asthenia; Bradycardia; Chest pain; Headache; Syncope	FLU3~PARKDALE PHARMACEUTICALS~E20248KD~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0115424	10/28/1998	NY	58.0	58		F	10/26/1998	arm sore, raised welts, hot, tender, painful to touch affected range of motion underneath arm pit in front of arm pit under arm opposite of inj site;									Y	10/23/1998	10/24/1998	1	NONE	OTH	OTH	Premarin;Tagamet;Vuterin	NONE	arthritis	~ ()~~~In patient		1						1	Hypokinesia; Lymphadenopathy; Myalgia; Pain; Urticaria; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0115425	10/28/1998	TX	43.0	43		F	10/26/1998	mild swelling @ inj site-severe muscle cramps from armpit, back of arm to elbow, swollen, hot, inflamed, T104.4, unable to walk d/t muscle cramps, nerve in rt leg;cannot walk;									N	10/22/1998	10/22/1998	0	NONE	PUB	OTH		NONE	RSD (Reflex Sympathetic Dystrophy-left leg), allergic to Demerol, Kef tabs	~ ()~~~In patient		1						1	Hypertonia; Hypokinesia; Injection site oedema; Lymphadenopathy; Myalgia; Neuritis; Pyrexia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~RA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0115426	10/28/1998	MS	41.0	41		U	10/24/1998	1hr post vax extreme nausea chills x 4hr-vomited x 3 times, eyes red, burning, mucus in the eyes-excessive-had to clean eyes several times;									Y	10/24/1998	10/24/1998	0	NONE	OTH	OTH	premarin	NONE	sulfa drug allergy	~ ()~~~In patient		1						1	Chills; Conjunctivitis; Eye pain; Lacrimal disorder; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115427	10/28/1998	MN	59.0	59		F	10/24/1998	hoarse, wheezy, felt like bronchitis & asthma, tightness in chest;									N	10/23/1998	10/23/1998	0	NONE	OTH	OTH	Premarin;Zestro;BP med	NONE	PCN	pt exp same rxn @ 57yr old w/flu vax;~ ()~~~In patient		1						1	Asthma; Bronchitis; Chest pain; Dysphonia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115428	10/28/1998	MO	46.0	46		F	10/23/1998	severe chills, almost passed out, anxiety, dizzy, rapid heart rate, thick tongue x 10-20min;									Y	10/22/1998	10/23/1998	1	NONE	PVT	OTH		NONE	PCN, seclor, hx mitral valve prolapse	pt exp chills @ 44yr w/flu vax;~ ()~~~In patient		1						1	Anxiety; Chills; Dizziness; Tachycardia; Tongue oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115429	10/28/1998	FL	60.0	60		M	10/23/1998	Pt recv vax on 10/21/98; on same day pt exp hives, swelling & red vax site x 24 hr; tx=Benadryl									Y	10/21/1998	10/21/1998	0	NONE	PVT	PVT	Glyburide BID	NONE	PCN	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Oedema; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~02988~3~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~451796~3~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0115430	10/28/1998	TX	67.0	67		F	10/24/1998	pt arm lt swelled up & became warm to touch about 1-2hr p/vax;the pain went away in about 24hr & th4e swelling in 72hr;pt took DPH & APAP;									Y	10/19/1998	10/19/1998	0		OTH	PVT	synthroid, premarin	NONE	NONe	~ ()~~~In patient		1						1	Oedema peripheral; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~0965760~7+~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~0871H~4~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0115433	10/28/1998	CA	48.0	48		F	10/19/1998	pt recv vax 230PM 8OCT98 by 10OCT98 rash appeared on back of hand & arm of vax in morning;by afternoon;rash appeared on chest, abd, back of legs;									N	10/08/1998	10/10/1998	2		PUB	PVT	NONE	NONE	allergy to PCN	~ ()~~~In patient		1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115435	10/28/1998	MA	78.0	78		F	10/20/1998	Pt recv vax on 10/15/98;on 10/16/98 pt exp fever (101.4) &Rt arm red, swollen &warm; tx=Tylenol &ice.									Y	10/15/1998	10/16/1998	1	UNK	OTH	PUB	Prednisone	Arthritis	Allergic to PCN, shellfish	UNK~ ()~~~In patient	MA9811	1						1	Injection site hypersensitivity; Injection site oedema; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975780~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0870H~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0115436	10/28/1998	MA	49.0	49		F	10/16/1998	Pt recv vax on 10/15/98;8 hr later pt exp red flush to skin of face, neck &chest w/ shortness of breath, fever (101.4); tx=Benadryl & Abafed.									Y	10/15/1998	10/15/1998	0	NONE	PUB	PVT	Aerobid, Uniphyll,Singulair,Aldactone, Flovent, Ventolin	NONE	Allergic to dogs, IVP dye, nuts (anaphylaxis) Pontocaine(ANA), small pox vax, asthma	Report states pt father recv flu vax at age 80 w/ adverse event~ ()~~~In patient		1						1	Dyspnoea; Pyrexia; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4988207~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0115438	10/28/1998	OH	69.0	69		M	10/26/1998	Pt recv vax on 10/13/98; on 10/14/98 pt exp tingling in fingers &toes w/ ascending paresthesia in LA. Pt still has sxs.										10/13/1998	10/14/1998	1	NONE	PVT	PVT	Many other meds	NONE	NKDA-Pt has HIN, DM, incr lipids, asthma	UNK~ ()~~~In patient		1						1	Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0975770~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115297	10/29/1998	PA	42.0			M	10/27/1998	Pt recv vax on 10/20/98; on 10/21/98 pt exp stiff LA, couldn't move LA, hot, swollen; fever (102), chills,				Y					Y	10/20/1998	10/21/1998	1	NONE	OTH	PUB	Atenolol	NONE	UNK	UNK~ ()~~~In patient	PA9902	1						2	Hyperhidrosis; Hypokinesia; Injection site mass; Injection site pain; Insomnia; Myalgia; Pyrexia; Hypertonia; Hypokinesia; Malaise; Oedema peripheral; Pyrexia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~MEDEVA PHARMA, LTD.~E20088FE~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0115455	10/29/1998	SC	47.0	47		F	10/19/1998	flu shot given thursday AM 10:15;rt arm started swelling in Pm; arm got hot & red;swollen, red area on rt arm 4x6 inches;also c/o itching in the area;										10/15/1998	10/15/1998	0	NA	PUB	PUB	Estrogen;BP med	NONE	NONE	NA~ ()~~~In patient	SC98059	1						1	Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0983300~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~0963390~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0115456	10/29/1998	OH	47.0	46		F	10/23/1998	wheezing, throat closing, coughed all noc, chest tight about 8PM 19OCT (lasting all noc);10OCT sweaty, freezing, pale, h/a, achy, sore throat;									Y	10/19/1998	10/19/1998	0		PUB	PUB	NONE	NONE	NKDA, allergies to cats	NONE~ ()~~~In patient		1						1	Asthma; Chills; Headache; Hyperhidrosis; Laryngospasm; Myalgia; Pallor; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~0977170~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115457	10/29/1998	CA	80.0	80		F	10/29/1998	high fever, uncontrollable chills, loss of strength in arms;in bed for four days (15 through 18) excessive evil smelling urine-uncontrollable;tea & drying toast & advil-still wobbly;									Y	10/14/1998	10/15/1998	1		UNK	UNK	Advil	NONE	arthritis @ times	NONE~ ()~~~In patient		1						1	Malaise; Myasthenic syndrome; Oedema; Pollakiuria; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115260	10/30/1998	MA	77.0	77		M	10/26/1998	pt recv vax & c/o vague sx of not feeling well, T102.4;reportedly the pt died on 22OCT98;	Y	10/22/1998			Y	2			N	10/21/1998	10/21/1998	0	T102-104;	OTH	OTH			ESRD, HTN	~ ()~~~In patient	U199800708	1						2	Malaise; Pyrexia; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0975790~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0115467	10/30/1998	CA	52.0	52		F	10/22/1998	pt recv vax 16OCT98 & reportedly w/in 3hr of vax pt exp dysarthria that lasted 45min;pt also exp diff controlling lt index finger & thumb;pt hosp over night for observation;					Y	1			Y	10/16/1998	10/16/1998	0	negative CT scan & ultrasound;	UNK	UNK				~ ()~~~In patient	U199800686	1						1	Dysarthria; Hypokinesia	FLU3~CONNAUGHT LABORATORIES~0971880~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0115469	10/30/1998	NY	72.0	72		M	10/28/1998	retrosternal pain w/deep breathing lasting, approx 24hr w/radiation to the lt shoulder, not w/cough;temp elevated;				Y	Y	2			Y	10/23/1998	10/25/1998	2	spino cat chest WBC to 100;echo;	PVT	OTH	Imipromen;Betapace;Comodin;Casodex;	NONE	PCN, pace maker, sinus synd, prostate	~ ()~~~In patient		1						1	Chest pain; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0984550~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0115470	10/30/1998	OH	29.0	29		F	10/27/1998	pt exp inc in heart rate, felt like would pass out, became diaphoretic;sx passed in 5min then broke out in itchy rash all over body;started @ balls of feet to tip of ears;rx DPH, solumedrol;				Y	Y	1			Y	10/26/1998	10/26/1998	0		OTH	PVT	NONE	NONE	bee sting allergy			1						1	Dizziness; Hyperhidrosis; Pruritus; Rash; Tachycardia	FLU3~CONNAUGHT LABORATORIES~0983380~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0115473	10/30/1998	CO	72.0	72		F	10/29/1998	lt arm swelling, erythema, warmth distal to inj site;actual inj site non tender, no masses palpable;				Y					Y	10/20/1998	10/20/1998	0	NOEN	PVT	PVT	Lipitor;Premarin	NONE	ASA, codeine, perocodan	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0977180~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454979~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0115474	10/30/1998	RI	60.0	60		M	10/20/1998	c/o dizziness-lightheaded-unsteady gait;slurred speech;				Y						10/17/1998	10/17/1998	0		PUB	OTH	ASA;Zantac	NONE	MI in MAR93;	~ ()~~~In patient	RI9806	1						1	Dizziness; Gait disturbance; Speech disorder	FLUX~UNKNOWN MANUFACTURER~~7+~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0115477	10/30/1998	NH	48.0	47		M	10/23/1998	pain in lt shoulder, deltoid & elbow starting 18OCT98 until the present;tried advil w/o effect;started on arthrotec on 22OCT98 p/seeing MD;				Y						10/15/1998	10/18/1998	3	NONE	PUB	PUB	arthrotec since 22OCT98	NONE	NONE	NONE~ ()~~~In patient	NH98017	1						1	Injection site pain; Pain	FLU3~MEDEVA PHARMA, LTD.~20178HA~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~CONNAUGHT LABORATORIES~7F91700~3~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0115481	10/30/1998	MD	74.0	73		F	10/27/1998	c/o ?hives lt forearm, lt arm on 19OCt98 took DPh @ home 10OCT98;erythema & warmth deltoid area & lt forearm wrist area;tx keflex;				Y					Y	10/19/1998	10/19/1998	0	NONE	PVT	PVT		NONE	2wk prior had bug bite lt wrist w/rx of cipro given 12OCT98 to use x 10 days	~ ()~~~In patient		1						1	Injection site hypersensitivity; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4988203~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0870H~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0115482	10/30/1998	MD	79.0	79		F	10/27/1998	redness & pain lt upper arm beginning 2 days p/vax; tx w/rocephin;				Y					Y	10/20/1998	10/20/1998	0	NONE	PVT	PVT		NONE	diabetes, inc cholesterol, hypothyroid	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4988203~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~UNKNOWN MANUFACTURER~0870H~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0115483	10/30/1998	MD	55.0	55		F	10/27/1998	seen in out of town ER 15OCT98 w/dx of cellulitis of lt upper arm;tx w/keflex;				Y					Y	10/13/1998	10/15/1998	2	NOEN	PVT	PVT		NONE	asthma	~ ()~~~In patient		1						1	Cellulitis; Injection site hypersensitivity	FLU3~PFIZER\WYETH~4988203~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0870H~1~~LA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~0923820~2~~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0115484	10/30/1998	MD	42.0	42		F	10/27/1998	17OCT98-18OCT98 pt devel redness, swelling, warmth, pain to rt upper arm; tx w/med;				Y					Y	10/16/1998	10/17/1998	1	NONE	PVT	PVT		NONE	diabetes, HBP	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4988203~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~0923820~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0115489	10/30/1998	NC	33.0	33		M	10/20/1998	partial facial hemiparesis;lt Bell's palsy;physical exam revealed partial lt hemiparesis of muscular distribution of NC VI;										10/08/1998	10/09/1998	1		MIL	MIL	NONE	NONE	NONE	~ ()~~~In patient		1						1	Facial palsy	FLU3~PFIZER\WYETH~2988247~5~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~MERCK & CO. INC.~1037B~1~IM~~HEP B (RECOMBIVAX HB)~1|JEV~CONNAUGHT LABORATORIES~EJN1428~4~SC~~JAPANESE ENCEPHALITIS (J-VAX)~1|TYP~CONNAUGHT LABORATORIES~N0081~3~IM~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0115490	10/30/1998	VA	47.0	47		F	10/26/1998	pain, swelling & fever noted lt deltoid p/vax 2 days prior;pt recv vax 21OCT98;									U	10/21/1998	10/23/1998	2		PUB	PUB	Synthroid	NONE		NONE~ ()~~~In patient	VA98069	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4988212~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0115492	10/30/1998	AL	9.0	9		M	10/21/1998	pt recv vax & returned about 1 1/2hr later w/pruritic skin rash;									Y	10/21/1998	10/21/1998	0	NONE	PUB	PUB		bronchitis		~ ()~~~In patient	AL9813	1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~0978490~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SMITHKLINE BEECHAM~2634A2~3~IM~LA~HEP B (ENGERIX-B)~1	USA		Influenza
0115495	10/30/1998	IN				M	10/21/1998	Pt recv vax on 10/20/98; on 10/21/98 pt exp red, irritated,flushed skin w/ itching & tenderness from head to toes.									U	10/20/1998	10/21/1998	1	UNK	OTH	PVT	Lipitor, Deprazone	UNK	UNK	Pt recv Flu vax in '97;exp serious rx.~ ()~~~In patient		1						1	Pain; Pruritus; Rash; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E202248KD~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0115501	10/30/1998	SD	44.0	43		F	10/21/1998	Pt recv vax on 10/16/98; on 10/16/98 pt exp tenderness at vax site; on 10/17/98 pt exp upset stomach and achiness, fever, nausea.									Y	10/16/1998	10/16/1998	0	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	SD99026	1						1	Dyspepsia; Injection site pain; Myalgia; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0968380~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115502	10/30/1998	OR	49.0	48		F	10/22/1998	Pt recv vax on 10/22/98; on same day pt exp hardness at vax site size of baseball, hot, itchy for 1 hr; treatment=ice.									Y	10/22/1998	10/22/1998	0	UNK	OTH	PVT	UNK	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4988199~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0115503	10/30/1998	OR	28.0	28		F	10/22/1998	Pt recv vax on 10/22/98; on same day pt exp hotness all over for 1/2 hr, entire arm painful.									Y	10/22/1998	10/22/1998	0	NONE	OTH	PVT	NONE	4 dy prior pt had stomach flu w/ diarrhea &vomit	NONE	NONE~ ()~~~In patient		1						1	Pain; Vasodilatation	FLU3~PFIZER\WYETH~4988199~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0115504	10/30/1998	OR	29.0	29		M	10/23/1998	Pt recv vax on 10/23/98; 1 hr later pt exp raised pink rash under LA w/ itching.									Y	10/23/1998	10/23/1998	0	N/A	OTH	PVT	NONE	NONE	NONE	UNK~ ()~~~In patient		1						1	Pruritus; Rash maculo-papular	FLU3~PFIZER\WYETH~4988199~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0115506	10/30/1998	PA	32.0	32		F	10/26/1998	Pt recv vax on 10/23/98; on same day pt exp achiness,chills,temp,shivers &vomited 2x.									Y	10/23/1998	10/23/1998	0	NONE	PUB	PUB	NONE	NONE	Penicillin, Sulfa, Slight hayfever	UNK~ ()~~~In patient	PA9901	1						1	Myalgia; Pyrexia; Tremor; Vomiting; Headache; Pyrexia; Tremor; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0115507	10/30/1998	GA	79.0	79		M	10/27/1998	Pt recv vax on 10/20/98; on 10/25/98 pt exp sore throat,weakness,fever,hoarseness,mucous in throat, &headache.									Y	10/20/1998	10/25/1998	5	NONE	PUB	OTH	Proscar	NONE	NONE	UNK~ ()~~~In patient		1						1	Asthenia; Dysphonia; Headache; Pharyngitis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0115508	10/30/1998	MA	80.0	80		F	10/27/1998	Pt recv vax on 10/24/98; on 10/25/98 pt exp aches, pains, congestion w/ productivity.									Y	10/24/1998	10/25/1998	1	UNK	PUB	PUB	UNK	NONE	Hypertension since 1994 (Nefedipine)	NONE~ ()~~~In patient		1						1	Myalgia; Pain; Pharyngitis; Pyrexia; Rhinitis; Infection; Injection site pain; Myalgia; Pharyngitis	FLUX~UNKNOWN MANUFACTURER~~3~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0115509	10/30/1998	CA	46.0	46		F	10/29/1998	Pt recv vax on 10/28/98; on same day pt exp itching at vax site, nausea,sinus swelling, hard to breath,eyes swelling, red rash on upper torso,achy,headache, fever &chills.									N	10/28/1998	10/28/1998	0	NONE	OTH	PVT	NONE	NONE	NONE	UNK~ ()~~~In patient		1						1	Dyspnoea; Face oedema; Headache; Myalgia; Nausea; Pruritus; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115510	10/30/1998	MA	57.0	57		F	10/28/1998	Pt recv vax on 10/19/98; on same day pt exp vax site swelling to size of fist, became hard &hot to touch, red, tender, itchy.									Y	10/19/1998	10/19/1998	0	NONE	OTH	PVT	NONE	NONE	NONE	Pt recv Flu vax at age 37; subsequently exp flu for 2 wk.~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Pruritus; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115511	10/30/1998	CA	77.0	77		F	10/27/1998	Pt recv vax on 10/20/98; on 10/24/98 pt exp fever, chills, bones aching, head tight, vomit for 3 day.									N	10/20/1998	10/24/1998	4	NONE	OTH	OTH	Ecotrin 1 a dy	NONE	Pacemaker for 3 yr	UNK~ ()~~~In patient		1						1	Bone pain; Headache; Pyrexia; Rhinitis; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115512	10/30/1998	AK	49.0	49		F	10/26/1998	Pt recv vax on 9/22/98; on 10/5/98 pt exp sore LA w/ limited ROM due to pain; tx=Tylenol, heat&ice										09/22/1998	10/05/1998	13	X-ray of upper arm-normal; Blood work-showed some inflammation	PVT	PUB	NONE	NONE	UNK	UNK~ ()~~~In patient		1						1	Arthralgia; Hypokinesia; Injection site pain; Laboratory test abnormal	FLU3~CONNAUGHT LABORATORIES~0973980~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115513	10/30/1998	IA	28.0	28		F	10/22/1998	Pt recv vax on 10/21/98; on 10/22/98 pt exp LA erythema(4x5cm) w/ induration.									Y	10/21/1998	10/22/1998	1	NONE	OTH	PUB	Theravite liquid,Folic acid tablet,DSS liquid,Levothroid tablet,Felbatol susp,Tylenol prn	NONE	Profound mental retardation w/absence of septum pellucidum,mixed seizures,spastic quadiparesis,microcephaly,left hip dislocation,hypothyroidism,blindness,hearing impaired,language disorder,constipation,status post-gastrostomy	NONE~ ()~~~In patient	IA98025	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4988203~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0113260	11/02/1998	IN	47.0			F	07/16/1998	A lit report described pt w/dec vision & transient pain in rt eye 1wk p/vax;5 days later devel blurriness in lt eye; defect  rt eye;optic discs edematous w/splinter hemorrhages & cotton-wool spots;disc atrophy;vasculopathy r/t neuropathy;				Y				Y	N	10/01/1994	10/01/1994	0	serum protein electrophoresis w/immunofixation;nonspecific polyclonal hypergammaglobulinemia;ESR-44;	OTH	OTH	NONE	unk	mild strabismic amblyopia, rt eye	~ ()~~~In patient	898288038A	1						2	Amblyopia; Eye disorder; Eye pain; Immunoglobulins increased; Optic atrophy; Red blood cell sedimentation rate increased; Visual disturbance; Visual field defect; Amblyopia; Eye disorder; Eye haemorrhage; Globulins increased; Neuropathy; Optic atrophy; Papilloedema; Red blood cell sedimentation rate increased	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Disabling	Influenza
0115514	11/02/1998	MS	86.0	86		F	10/21/1998	pt recv vax approx 830AM & pt pronounced dead on front steps of home;between 1:00 & 2PM 19OCT98 by medical examiner;	Y	10/19/1998							N	10/19/1998	10/19/1998	0		PUB	PUB		when asked if sick of feeling bad;pt did not report any problems	NONE	~ ()~~~In patient	MS98022	1						1	Arteriosclerosis; Cardiovascular disorder	FLU3~MEDEVA PHARMA, LTD.~E20158HG~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0115524	11/02/1998	TX	51.0			F	07/16/1998	A lit report described pt who devel fever w/chills & myalgia 1 day p/vax;4wk post vax exp ear pain, h/a, blurry vision rt eye & lt eye;visual acuity 25/50 in rt eye 20/25 in lt eye;optic discs edematous;vasculopathy r/t neuropathy				Y				Y	N	10/01/1994	11/01/1994	31	fluorescein angiography: late optic disc staining consistent w/disc edema;	OTH	OTH	unk	unk		~ ()~~~In patient	898299001L	1						1	Amblyopia; Headache; Neuropathy; Optic atrophy; Papilloedema; Vasculitis; Visual disturbance; Visual field defect	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0115533	11/02/1998	MI	78.0	78		F	10/22/1998	Pt recv vax on 10/2/98; on 10/3/98 pt exp swollen,bruised &hot Rt arm; tx=ice packs.				Y						10/02/1998	10/03/1998	1	NONE	PUB	PUB	Coumadin,Lanoxin,Hyzaar	NONE	Chronic heart condition,Valve replacement-12 yr ago,Hypertension	NONE~ ()~~~In patient	MI98117	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site reaction; Oedema peripheral; Vasodilatation	FLU3~PFIZER\WYETH~4988204~7+~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0115535	11/02/1998	MS	61.0	61		F	10/20/1998	Pt recv vax on 10/15/98; on same day pt exp nausea, vomit, difficulty breathing; pt to E.R. via ambulance.				Y					Y	10/15/1998	10/15/1998	0	Stat. Troponin-I (ng/mL) <0.3	PUB	PVT	Claritin,Premarin,Lotrel,Synthroid,Hydrochlorol,Glucotrol,Paxil,Prilosec,Amaryl,Guaifenex,Propacet	UNK	NIDDM,DSD, Hypothyroid, Chronic anemia	N/A~ ()~~~In patient	MS98020	1						1	Dyspnoea; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E20158HA~3~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~454379~2~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0115536	11/02/1998	NY	75.0	74		M	10/26/1998	Pt recv vax on 10/23/98; 5 hr later pt exp weakness.				Y					N	10/23/1998	10/23/1998	0	HIGH-glucose,blood urea nitrogen,serum creatinine,hemoglobin AlC,WBC,MCH,Neutro,monocytes,seg neutro; LOW-sodium,chloride,total protein,albumin,A/G ratio,RBC,Hemoglobin,hematocrit, auto lymph,diff lymph	OTH	OTH	Rezulin, Insulin	UNK	UNK	UNK~ ()~~~In patient		1						1	Anaemia; Asthenia; Blood urea increased; Hyperglycaemia; Hypochloraemia; Hyponatraemia; Hypoproteinaemia; Leukocytosis	FLU3~CONNAUGHT LABORATORIES~0984530~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0115539	11/02/1998	MS	77.0	77		M	10/27/1998	Pt recv vax on 10/26/98; on 10/27/98 pt exp pain in upper Rt arm, swelling &redness, dec movement; E.R. tx=Benadryl,Tylox,ice.				Y					N	10/26/1998	10/27/1998	1	NONE	PUB	OTH	Vitamins	NONE	Allergic to niacin-cardiovascular disease-angioplasty 2/98	NONE~ ()~~~In patient	MS98023	1						1	Hypokinesia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Pain	FLU3~MEDEVA PHARMA, LTD.~E20158H6~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1541E~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0115542	11/02/1998	MI	67.0	67		F	10/05/1998	Pt recv vax on 10/2/98; on same day pt exp achiness in arms to neck, hot &cold flashes, dizzy, laryngitis, myalgia, head congested.				Y					U	10/02/1998	10/02/1998	0	NONE	PUB	PUB	NONE	NONE	Chronic bronchitis, asthma history	Pt recv Flu vax 6-7 yr ago local rx at vax site~ ()~~~In patient	MI98116	1						1	Chills; Dizziness; Injection site pain; Laryngitis; Myalgia; Neck pain; Rhinitis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975850~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0304H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0115543	11/02/1998	OH	67.0	67		F	10/19/1998	pt recv vax 5OCT98 & 6OCT98 got rash starting on arms has not spread to legs, chest, back & neck;no fever, feels well, no itching, rash red, raised pimply-blotchy, nausea;to call MD;				Y					Y	10/05/1998	10/06/1998	1		PUB	PUB	BP medicine	NONE	erythromycin, codeine, HTN recent end of August	NONE~ ()~~~In patient	OH98076	1						1	Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~0978660~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0115544	11/02/1998	WI	26.0	25		F	10/13/1998	6OCT98 pt recv vax & 12hr later 7OCT98 n/v, fever;seen in ER IV fluids-myalgias, cont w/sx seen 8OCT98;				Y					Y	10/06/1998	10/07/1998	1	NONE	OTH	PVT	Tri-phasil 28	NONE	NONE	NONE~ ()~~~In patient		1						1	Myalgia; Vomiting; Chest pain; Dehydration; Diarrhoea; Malaise; Nausea; Vomiting; Chest pain; Dehydration; Diarrhoea; Malaise; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~0977180~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0977180~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~0977180~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Emergency room visit	Influenza
0115547	11/02/1998	MI	62.0	62		F	10/08/1998	pt recv vax 7OCT98 2PM & 3Pm noticed 50 cent piece size swollen, hard white area @ inj site;called hlth dept 430PM was instructed to apply warm compress;area of swelling progressed to redness & hot, spreading from elbow to under axilla;ER				Y					U	10/07/1998	10/07/1998	0	NONE	PUB	PVT	Pravochol, Toprol, Norvasc, Premarin		Darvon under tx for HTN, high cholesterol, splenectomy 1998	~ ()~~~In patient	MI98109	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Lymphadenopathy; Oedema peripheral; Vasodilatation	FLU3~PFIZER\WYETH~4988204~5~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~445644~2~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0115550	11/02/1998	OK	49.0	49		F		pt recv vax 20OCT98 & 30min p/vax had a rxn @ 12noon;difficulty breathing, paleness, weakness, fast heart beat, dry mouth, dizziness;				Y					Y	10/20/1998	10/20/1998	0	NOEn	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	OK9837	1						1	Asthenia; Dizziness; Dry mouth; Dyspnoea; Pallor; Tachycardia	FLUX~UNKNOWN MANUFACTURER~U0918351~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0115551	11/02/1998	OK	72.0	72		F	10/15/1998	3 days p/vax pt awoke & rt arm red, hot & swollen & itching, no pain, no fever, no n/v;				Y						10/08/1998	10/11/1998	3	NONE	PVT	PVT	Premarin & chinese dydrastic/herbal supplement, canadenis/centrum silver	abd pain	PCN	NONE~ ()~~~In patient	OK9838	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20168GA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~CONNAUGHT LABORATORIES~0970520~2~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0115552	11/02/1998	FL	42.0	42		M	10/28/1998	3 days p/vax pt felt dizzy & nauseated lasted several hr;5th day p/vax s/s came back & pt started to have nausea, dizziness again w/cramping & diarrhea & really abd vomiting;it lasted 24hr;pain;can't sleep				Y					N	10/15/1998	10/18/1998	3	NA	PUB	PUB	NONE	s/p abd surgery 24SEp98	bullet wound 24SEP98, s/p abd surgery, bullet was not removed becasue it is next tot he spine but 8 of intestines according to pt they removed;	NONE~ ()~~~In patient	FL98055	1						1	Diarrhoea; Dizziness; Hypertonia; Insomnia; Nausea; Pain; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E20138HA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0115553	11/02/1998	MS	74.0	74		F	10/21/1998	went to ER 14OCT98 approx 6PM; d/t edema, rash, pain, edema of rt arm where vax given;edema & redness almost to elbow;no c/o n/v, diff breathing;				Y					Y	10/14/1998	10/14/1998	0		PUB	UNK				NONE~ ()~~~In patient	MS98021	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20158HG~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1542E~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0115556	11/02/1998	KY	58.0	58		F	10/30/1998	pt stated woke up 12AM & felt could not breath;pt was taken to the ER & was given epi & DPH;pt was sent home;c/o h/a x 24hr p/episode;									Y	10/22/1998	10/23/1998	1	unk	PUB	PUB	Naprelan & 1/2 ASA	NONE	allergic to codeine	~ ()~~~In patient	KY980034	1						1	Dyspnoea; Headache; Insomnia	FLU3~MEDEVA PHARMA, LTD.~E20138GB~2~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0115559	11/02/1998	MI	60.0	60		F	10/23/1998	pt recv vax 13OCT98 & 15OCT c/o soreness under arm-radiated to back (lt side);saw MD 19OCT;also x-ray of lungs;				Y					N	10/13/1998	10/15/1998	2	x-ray nl;	PUB	UNK	NONE	NONE	NONE	~ ()~~~In patient	MI98119	1						1	Back pain; Lymphadenopathy	FLU3~PFIZER\WYETH~4988204~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0115562	11/02/1998	CA	63.0			U		pt recv vax 21OCT98 & 27OCT98 evening, had shaking, chills, no obvious fever, n/v, some aches, loss of appetite, very weak until & through 30OCT;										10/21/1998	10/27/1998	6		UNK	UNK				~ ()~~~In patient		1						1	Anorexia; Asthenia; Chills; Myalgia; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115563	11/02/1998	PA	35.0			M	10/28/1998	dizziness & ringing in ears x 1hr;									Y	10/28/1998	10/28/1998	0		OTH	PVT	NONE	T99	seasonal allergies	~ ()~~~In patient		1						1	Dizziness; Tinnitus	FLU3~CONNAUGHT LABORATORIES~0972840~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115564	11/02/1998	MI	81.0	81		M	10/09/1998	last noc 5hr p/vax started getting red & swollen;MD recommended cool compress to site;pt also reports took DPH;states swelling has gone down but heat & redness still there;									U	10/07/1998	10/07/1998	0	NA	PUB	PVT	ASA;Lipitor	NONE	inc cholesterol	NONE~ ()~~~In patient	MI98110	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4988204~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~445644~1~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0115568	11/02/1998	MI	62.0	62		F	10/22/1998	pt recv flu vax 14OCT98 1300 & diarrhea started on 16OCT98;has had until 22OCT98 (still has);rash started 22OCT98 over entire body which is pinkish red, flat & no open areas;no itching w/rash;afeb;also has fatigue, achiness & dizziness;									U	10/14/1998	10/16/1998	2		UNK	UNK	Synthroid	rt upper arm soreness;loose chronic stools;	hepatitis B 78 or 80;hypercholesterolemia;	~ ()~~~In patient	MS98121	1						1	Asthenia; Diarrhoea; Dizziness; Myalgia; Rash maculo-papular	FLU3~PFIZER\WYETH~8013~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0115571	11/02/1998	CA	82.0	82		U		erythema @ site of inj;warmth, erythema & edema of ipsilateral arm;									U	10/19/1998			NONE	PVT	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Oedema peripheral; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0983300~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115572	11/02/1998	CA				U		erythema @ site of inj, warmth, erythema & edema of distal forearm (ipsilateral);									U				NONE	UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Oedema peripheral; Rash; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~0983300~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115576	11/02/1998	MS	65.0	65		F	10/14/1998	pt recv vax 12OCT98 &  13OCT98 pt came to nurse lt arm red & warm to touch @ inj site about a half dollar size area;									Y	10/12/1998	10/13/1998	1	NONE	PUB	PUB	hormone	NONE	NONE	~ ()~~~In patient	MS98019	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20158HG~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0115578	11/02/1998	IA	63.0	62		M	10/30/1998	lt arm swollen & red approx 4hr p/vax;arm painful;remains swollen 30OCT98;no redness noted has started itching 30OCT98 AM;									Y	10/29/1998	10/29/1998	0	NONE	PUB	PUB	NONE	NONE	NKA	NONE~ ()~~~In patient	IA98030	1						1	Injection site oedema; Oedema peripheral; Pain; Pruritus	FLU3~CONNAUGHT LABORATORIES~0971390~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0871H~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0115582	11/02/1998	IA	37.0			F	10/27/1998	noted several small pimples like scattered on abd, 2-3 pimples on arms;no redness around pimples-no itching;										10/22/1998	10/26/1998	4		PUB	PUB	NONE	cold sx		~ ()~~~In patient	IA98031	1						1	Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~0978720~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115583	11/02/1998	IA	77.0	77		F	10/27/1998	on day of vax exp aching down arm, through elbow & n to thumb;24hr later discomfort had localized to mostly near site of inj;pt contacted 26 days p/vax report tenderness remains @ site & exp aching in the arm;									U	10/01/1998	10/01/1998	0		PUB	PUB		NONE	NONE	~ ()~~~In patient	IA98028	1						1	Injection site pain; Myalgia	FLU3~CONNAUGHT LABORATORIES~0973930~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115584	11/02/1998	OH	71.0	71		F	10/19/1998	fever on arm of inj rt excruciating pain in arm;chills every joint hurt;slept most of the time for 3 days;p/vax pt couldn't walk for several hr took advil for 3 days, did not call MD stated that could have been hosp;									Y	10/15/1998	10/16/1998	1	NONE	PUB	PVT	Glucoma eye drops;provera/premarin	NONE	NKA;psoriasis-glucoma;	~ ()~~~In patient	OH98075	1						1	Arthralgia; Chills; Myalgia; Somnolence; Vasodilatation	DT~CONNAUGHT LABORATORIES~1389E~UNK~~RA~DT ADSORBED (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~0983290~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~1389E~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0115585	11/02/1998	OH	63.0	62		F	10/19/1998	immed felt itching @ site;area hot to touch;19OCT98 swelling down to elbow;+ swelling & warmth rt arm;mild erythema medial arm;									Y	10/16/1998	10/16/1998	0	NOEN	PUB	PUB	Premarin;Fosomex	NONe	hayfever, dust pollen, sinus only	~ ()~~~In patient	OH98077	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0971890~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454379~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0115586	11/02/1998	GA	66.0	66		F	10/09/1998	pt recv vax 8OCT98 & 145PM next morning broke out w/bumps, had some roughness noc before just from neck up;no resp distress;nausea;										10/08/1998	10/08/1998	0		PUB	PUB				~ ()~~~In patient	GA98094	1						1	Rash	FLU3~MEDEVA PHARMA, LTD.~E20148HD~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0115757	11/02/1998	NC	41.0			F	10/26/1998	pt recv vax 20OCT97 & that same day 20OCT97 20OCT97 pt exp double vision while driving home;pt f/u w/an eye MD & dx w/esotropia hyperopia;exp small angle esotropia w/double & distant vision;				Y					Y	10/20/1997	10/20/1997	0		UNK	UNK	Klonopin		fibromyalgia;pt was recently dx w/fibromyalgia;	~ ()~~~In patient	19970249261	1						1	Diplopia; Eye disorder; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~SMITHKLINE BEECHAM~2370A4~3~IM~LA~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0115955	11/02/1998	GA	54.0	54		F	10/26/1998	pt recv vax 26SEP97 & 17OCT97 pt devel elevated ASt & ALT levels;									Y	09/26/1997	10/17/1997	21		PVT	PUB	Cozaar;Precose;		elevated liver function tests;	~ ()~~~In patient	19980128731	1						1	Alanine aminotransferase increased; Aspartate aminotransferase increased	FLU3~PFIZER\WYETH~~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~SMITHKLINE BEECHAM~2220B6~2~IM~RA~HEP B (ENGERIX-B)~1	USA		Influenza
0115593	11/03/1998	MN	14.0	13		M	10/26/1998	tonic clonic sz 1 day p/vax;			Y	Y					U	10/23/1998	10/24/1998	1	nl glucose, lytes, Ca+, Mg, CBC, EEG scheduled;PCO2 40.7;	OTH	OTH	unk	unk	unk	unk~ ()~~~In patient		1						1	Acidosis; Convulsion; Hypertonia; Hypotonia; Convulsion; Convulsion	FLU3~PARKDALE PHARMACEUTICALS~02298P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~02298D~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~2|FLUX~UNKNOWN MANUFACTURER~02298D~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Life Threatening	Influenza
0115594	11/03/1998	MN	17.0	16		M	10/26/1998	status epileptic x 20min w/break through sz requiring hosp;			Y	Y	Y				U	10/23/1998	10/26/1998	3	urine fax screen pending; neg CT of head, nl glucose, CBC, Mg, Ca, lytes, EEG scheduled	OTH	OTH	Valium;Dilantin	NONE	NONE	NONE~ ()~~~In patient		1						1	Convulsion	FLU3~PARKDALE PHARMACEUTICALS~02298P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation	Influenza
0115595	11/03/1998	IL	19.0	19		M	10/28/1998	devel dizziness, confusion, fatigue 17OCT98 w/progressive weakness & some paresthesia;hosp;dx GBS;					Y				U	10/08/1998	10/17/1998	9		OTH	OTH	NONE	NONE		~ ()~~~In patient		1						1	Asthenia; Confusional state; Dizziness; Guillain-Barre syndrome; Paraesthesia	FLU3~PARKDALE PHARMACEUTICALS~02988P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0115597	11/03/1998	TX	2.0	2	.6	M	10/26/1998	pt recv vax 23OCT98 & that noc lt leg began to swell & sustained fever up to 104;hosp 24OCT98-28OCT98 p/developing erythema, massive swelling, pain in the leg;				Y	Y	5			Y	10/23/1998	10/24/1998	1	WBC 12,800	PVT	PVT		NONE	asthma, allergic rhinitis recurrent OM & pneumonia	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Pyrexia; Asthma; Hypokinesia; Injection site oedema; Jaundice; Pyrexia; Rash	DT~CONNAUGHT LABORATORIES~7C91563~5~IM~LL~DT ADSORBED (NO BRAND NAME)~1|FLU3~PARKDALE PHARMACEUTICALS~02298P~3~IM~RL~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~0906E~1~SC~LL~PNEUMO (PNEUMOVAX)~1|DT~CONNAUGHT LABORATORIES~7C91563~5~IM~LL~DT ADSORBED (NO BRAND NAME)~2|FLU3~PARKDALE PHARMACEUTICALS~02298P~3~IM~RL~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~MERCK & CO. INC.~0906E~1~SC~LL~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0115598	11/03/1998	AL	78.0	78		F		devel shingles day p/ on same dermatone as inj of lt deltoid;has had prev flu vax x1yr ago no adverse rxn then 6OCT97;pt exp blisters & sore arm beginning day p/vax;BP 118/62;T96.9;got classic shingles;				Y					N	10/19/1998	10/20/1998	1	NONE	PVT	PVT		NONE	HTN	NONE~ ()~~~In patient		1						1	Dermatitis bullous; Herpes zoster; Hypotension; Hypothermia	FLU3~CONNAUGHT LABORATORIES~0981840~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0115607	11/03/1998	MN	49.0	49		F	10/05/1998	reddened area around inj site 5 1/2cm diameter;				Y					Y	10/01/1998	10/02/1998	1		PVT	PVT	Claritin;Ortho cyclen	NONE		~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~0978670~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0115611	11/03/1998	MI	42.0	42		F	10/20/1998	Pt recv vax on 10/12/98; on 10/13/98 pt exp noise in ears, loud hearing & roaring, sensitivity to sounds & dizzy. Dx=tinnitus				Y					N	10/12/1998	10/13/1998	1	UNK	PUB	PVT	ELAVIL	NONE	Fibromyalgia, food sensisitivities	NONE~ ()~~~In patient		1						1	Dizziness; Hyperacusis; Tinnitus; Dizziness; Hyperacusis; Tinnitus; Vestibular disorder	FLU3~PFIZER\WYETH~4988204~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0115613	11/03/1998	PA	62.0	62		F	10/29/1998	Pt recv vax on 10/28/98; on 10/29/98 pt exp swollen facial cheeks w/ erythema, headache & nausea; LA ecchymotic at vax site.				Y					Y	10/28/1998	10/29/1998	1	UNK	PVT	PUB	Premarin, Vitamin B & E, Dexamethorophan	NONE	Penicillin & Neurontin	NONE~ ()~~~In patient		1						1	Ecchymosis; Face oedema; Headache; Injection site reaction; Nausea; Rash	FLU3~MEDEVA PHARMA, LTD.~E20138GB~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0115616	11/03/1998	TX	34.0	34		F	10/28/1998	Pt recv vax on 10/23/98; on 10/24/98 pt exp pain & swelling of lymph nodes in left axilla & breast for several day; felt tired & weak.									N	10/23/1998	10/24/1998	1	NONE	PUB	PVT	Birth control pills	NONE	NONE	NONE~ ()~~~In patient		1						1	Asthenia; Lymphadenopathy; Oedema; Pain	FLU3~PARKDALE PHARMACEUTICALS~02198P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0115617	11/03/1998	CA	57.0	57		F	10/25/1998	Pt recv vax on 10/7/98; 1 hr later pt exp nausea, painful arm, headache, body ache; tx=Tylenol									Y	10/07/1998	10/07/1998	0	UNK	OTH	OTH	NONE	N/A	Ampicillin, Tetracycline, Codiene	UNK~ ()~~~In patient		1						1	Headache; Myalgia; Nausea; Pain	FLU3~PARKDALE PHARMACEUTICALS~LO3788P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0115619	11/03/1998	WY	69.0	69		M	10/29/1998	Pt recv vax on 10/23/98; on 10/24/ pt exp redness, swelling, warmth & pain of Rt arm; tx=Advil &ice.									Y	10/23/1998	10/24/1998	1	NONE	PVT	PVT	UNK	NONE	Pramasone topical allergy, DJD, HTN	UNK~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0978660~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~451951~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0115621	11/03/1998	CA	27.0	27		F	10/20/1998	Pt recv vax on 10/15/98;  1 hr later pt exp itching &hives at vax site (3X3); swollen lymph node to left clavicle area.									Y	10/15/1998	10/15/1998	0	NONE	PUB	PVT	Accutane	NONE	NONE	UNK~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Lymphadenopathy; Pruritus; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E20158HH~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0115623	11/03/1998	IL	46.0	46		F	10/27/1998	pt recv vax 5OCT98 & 16OCT98 hands & feet turned red,  legs turning red, lt leg hives & splotching 7OCT98;all joints painful, difficult to walk, no strength in joints, h/a;immune rxn;									Y	10/05/1998	10/06/1998	1	NA	PUB	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Headache; Hypokinesia; Immune system disorder; Myasthenic syndrome; Oedema peripheral; Rash maculo-papular; Urticaria	FLU3~CONNAUGHT LABORATORIES~0975790~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115628	11/03/1998	KS	45.0	45		F	10/27/1998	approx 1hr p/vax pt devel hives, itching of palms of hands, tightness in throat & wheezing;took DPH & sx gradually resolved in 2hr;									Y	10/20/1998	10/20/1998	0		PUB	PUB	Premarin	NONE	reports ome sx w/latex;allergy latex, ASA, codeine, Unicef;	~ ()~~~In patient	KS98043	1						1	Asthma; Laryngospasm; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4988206~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0115629	11/03/1998	AL	48.0	48		F	10/26/1998	pt recv vax in lt arm & w/in 15hr lt arm inflamed, mildly swollen, sore to touch, could not raise arm above shoulder, muscle tenderness;									Y	10/14/1998	10/15/1998	1		OTH	PVT	Premarin	NONE	MVP w/dysautonomia	~ ()~~~In patient		1						1	Hypokinesia; Injection site inflammation; Injection site oedema; Injection site pain; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0115630	11/03/1998	TN	51.0	51		M	10/22/1998	exp muscle aches & pains for 2 to 3 days then had very sensitive skin that moved around to various parts of the body for about 1 1/2wk a/it finally disappeared;later exp signs of bad cold, congestion & cough;									U	10/06/1998	10/07/1998	1	NA	OTH	OTH	NONE	NONE	7wk postop up3	NA~ ()~~~In patient		1						1	Cough; Hypoaesthesia; Myalgia; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0968420~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115633	11/03/1998	MN	56.0	56		F	10/26/1998	Pt recv vax on 10/20/98; on same day pt exp cough, tight chest, eye itch & swelling, fever &chills X 1 day									Y	10/20/1998	10/20/1998	0	NONE	OTH	OTH	Blood pressure med	NONE	High   blood pressure, Stroke 2 yr prior	NONE~ ()~~~In patient		1						1	Chest pain; Cough; Face oedema; Pruritus; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0983310~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115634	11/03/1998	WI	4.0			M	10/26/1998	Pt recv vax on 10/23/98; on 10/24/98 pt exp cellulitis on left thigh, fever (103); tx=Augmentin & Ceftriaxone.									Y	10/23/1998	10/24/1998	1	NONE	PVT	PVT	Vitamin K, Fludrocortisone, DHA, Cortef, Depatrarne	NONE	Adrenoleukodystrophy, seizures	UNK~ ()~~~In patient		1						1	Cellulitis; Pyrexia	FLU3~PFIZER\WYETH~4988206~4~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~454382~1~IM~LL~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0115635	11/03/1998	CA	28.0			F	10/28/1998	Pt recv vax on unspecified day; 2 hr later pt exp vomiting, chest tightness, wheezing w/ inspiration, X 3 hr.  Pt exp decreased motion LA, fatigue, left hand cold.									N				UNK	OTH	OTH	UNK	Fatigue	Vicodin-nausea	UNK~ ()~~~In patient		1						1	Asthma; Chest pain; Chills; Condition aggravated; Hypokinesia; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E20298LA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0115636	11/03/1998	CO	65.0			F	10/29/1998	Pt recv vax on unspecified day; pt exp urticaria									Y				UNK	PUB	OTH	Trazadone, Premarin, Calcium carbonate	NONE	NKDA	UNK~ ()~~~In patient		1						1	Urticaria	FLU3~PFIZER\WYETH~4988216~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0115638	11/03/1998	WA	36.0	35		F	10/26/1998	Pt recv vax on 10/23/98; on 10/24/98 pt exp swelling at injection site w/ pain (2.5 x 1.5 cm).									Y	10/23/1998	10/24/1998	1	NONE	OTH	OTH	Nordette	NONE	NONE	Pt recv TD vax; age 21; 3/83 adverse event~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0972880~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115639	11/03/1998	MA	37.0	37		F	10/19/1998	Pt recv vax on 9/21/98; on same day pt exp fever (101.6), chills, body aches, headache									Y	09/21/1998	09/21/1998	0	NONE	OTH	OTH	NONE	NONE	NONE	UNK~ ()~~~In patient		1						1	Headache; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~15418~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0115640	11/03/1998	MA	48.0	48		F	10/19/1998	Pt recv vax on 9/21/98; on same day pt exp fever, chills, cough, difficulty breathing									Y	09/21/1998	09/21/1998	0	NONE	OTH	OTH	Prozac	NONE	NONE	NONE~ ()~~~In patient		1						1	Cough; Dyspnoea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115641	11/03/1998	MA	58.0	58		M	10/02/1998	Pt recv vax on 9/21/98; on same day pt exp fever (101.6), chills, muscle aches, headache									Y	09/21/1998	09/21/1998	0	NONE	OTH	OTH			Diabetic	NONE~ ()~~~In patient		1						1	Headache; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~15418~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0115642	11/03/1998	WY	66.0	66		F	10/29/1998	Pt recv vax on 10/6/98; 1 hr later pt exp soreness of Rt arm, difficulty moving arm, ecchymosis of Rt arm									Y	10/06/1998	10/06/1998	0	N/A	PVT	PVT	Coumadin,Niferex,Zoloft,Nifedipine, Nitrobid,Amitriptyline, Cytotec,Prevacid, APA,Multivitamin,Vitamin E & C	NONE	Hyperparathyroidism,Depression,Osteoporosis,Clotting disorder,SLE,PUD/GERD,CRST Syndrome,Anemia,Atrial Fibrillation,Glucose intolerance	Pt recv PPV 2/21/92 exp same rx~ ()~~~In patient		1						1	Ecchymosis; Injection site pain; Injection site reaction; Pain	FLU3~MEDEVA PHARMA, LTD.~E20158HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~448189~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0115269	11/04/1998	NY	85.0	85		F	10/28/1998	pt recv vax 14OCT98 & same day pt c/o weakness, achy & joint pain;18OCT pt was adm to hosp for arthritis, r/o sepsis;					Y	8			Y	10/14/1998	10/14/1998	0		UNK	UNK				~ ()~~~In patient	U199800716	1						2	Arthralgia; Arthritis; Asthenia; Flatulence; Leukocytosis; Myasthenic syndrome; Osteoarthritis; Sepsis; Arthralgia; Arthritis; Asthenia; Myalgia; Sepsis	FLU3~CONNAUGHT LABORATORIES~0981800~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0981800~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0115696	11/04/1998	PA	50.0			M	10/30/1998	pt recv vax & exp migraine h/a, n/v evening p/vax;pt then exp muscle aches/soreness;24OCT98 pt exp migraine again & was hosp;spinal tap revealed inc WBC;pt still in hosp @ time of reporting & has been dx w/viral encephalitis;					Y				Y	10/15/1998	10/15/1998	0	spinal tap revealed inc WBC;	OTH	OTH			migraine, unspecified status;hx of;	~ ()~~~In patient	MPI981942	1						1	CSF test abnormal; Condition aggravated; Encephalitis; Headache; Infection; Leukocytosis; Myalgia; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E20088FE~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0115707	11/04/1998	VT	49.0			F	10/23/1998	pt recv vax & exp sweat, numbness in feet & hands;pt then put in hosp;GBS 3 days later in ICU;had bell's palsy;had to learn to talk, eat, walk again;pt states was in perfect health a/shot;					Y			Y			10/27/1988			UNK	UNK				~ ()~~~In patient		1						1	Anorexia; Asthenia; Facial palsy; Guillain-Barre syndrome; Hyperhidrosis; Hypokinesia; Myasthenic syndrome; Pain; Paraesthesia; Speech disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0115710	11/04/1998	IL	63.0	63		M	10/20/1998	Pt recv vax on 10/14/98; on 10/15/98 pt exp no hearing in left ear; pt saw M.D. 10/20; dx=wax build up.				Y					Y	10/14/1998	10/15/1998	1	UNK	PUB	PUB		NONE	UNK	UNK~ ()~~~In patient	IL98078	1						1	Deafness transitory; Ear disorder	FLU3~CONNAUGHT LABORATORIES~0978660~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0115714	11/04/1998	OH	61.0	61		F	11/02/1998	Pt recv vax on 10/27/98; 5 - 10 min later pt became diaphoretic, lightheaded, unresponsive, pulse not palpable;bradycardia, vomited; tx=ammonia capsule				Y					U	10/27/1998	10/27/1998	0	UNK	PUB	PVT	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Bradycardia; Dizziness; Hyperhidrosis; Stupor	FLU3~MEDEVA PHARMA, LTD.~E20198HA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0115715	11/04/1998	UT	19.0	19		F	10/19/1998	Pt recv vax on 10/15/98; post vax pt exp lightheaded, nausea, dizzy, weak & shaky, unconscious 3-4 min				Y					Y	10/15/1998	10/15/1998	0	Blood test-unknown results, blood sugars	PUB	PUB	NONE	NONE	Hypoglycemia, Penicillin allergy, Hay fever	Pt recv Flu/PPV vax age 18~ ()~~~In patient	UT982717	1						1	Asthenia; Dizziness; Hypotension; Hypoxia; Nausea; Syncope; Tremor	FLU3~PFIZER\WYETH~4988200~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0115717	11/04/1998	TN	32.0	31		M	10/30/1998	Pt recv vax on 10/29/98; on same day pt exp rash on torso, upper respiratory congestion, myalgia; tx=Epi injection & 2 meds				Y					Y	10/29/1998	10/29/1998	0	NONE	OTH	PUB	UNK	NONE	Hives during childhood	UNK~ ()~~~In patient		1						1	Myalgia; Pharyngitis; Rash; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0983290~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0115718	11/04/1998	OK	34.0	33		M	10/26/1998	Pt recv vax on 10/12/98; on 10/13/98 pt exp chills, achiness, fever (100), fatigue, head congestion, productive cough x 10 day				Y					Y	10/12/1998	10/13/1998	1	CBC- NORMAL	OTH	PVT	NONE	NONE	NONE	UNK~ ()~~~In patient		1						1	Asthenia; Cough; Myalgia; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0971890~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0115719	11/04/1998	NY	27.0	27		F	10/26/1998	Pt recv vax on 10/25/98; on same day pt exp LA pain & tingling, swelling, rash in deltoid region. It was reported that a 27-year-old female received FLUZONE SV '98-'99 USP on October 25, 1998. Reportedly that same day the patient expereinced a local reaction, tingling with difficulty grasping and rash on both arms. Follow-up #1 (28/Jun/2002): During internal reviewing of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (added an AE-=DIFICULTY GRASPING and coded it to DYSKINESIA).				Y					U	10/25/1998	10/25/1998	0	UNK	OTH	UNK	UNK	UNK	Leratabi Bactrim, Asthma, migraines, fibromyalgia, congenital displaced hip	NONE~ ()~~0.00~Patient	U199800712	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0984530~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0115720	11/04/1998	MI	34.0	34		F	10/26/1998	Pt recv vax on 10/19/98; on 10/22/98 pt exp sore LA, swollen, fatigue				Y					Y	10/19/1998	10/22/1998	3	NONE	PUB	PVT	Cutaflam, Orthonova	NONE	Rheumatoid arthritis, allergy to Penicillin & Amoxicillin	UNK~ ()~~~In patient		1						1	Asthenia; Lymphadenopathy; Myalgia; Oedema; Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~0977210~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0115723	11/04/1998	MD	47.0	47		F	10/26/1998	Pt recv vax on 10/21/98; 1/2 hr later pt exp headache & dizziness, weak &tingling legs, popping sound in head				Y					Y	10/21/1998	10/21/1998	0	NONE	PUB	OTH	NONE	NONE	NONE	UNK~ ()~~~In patient		1						1	Asthenia; Bradycardia; Dizziness; Headache; Hypertension; Hypotension; Myasthenic syndrome; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E20228KC~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0115724	11/04/1998	NC	46.0	46		F	10/30/1998	Pt recv vax on 10/22/98; on same day pt exp wooziness, hot face, dizziness, nausea				Y					Y	10/22/1998	10/22/1998	0	NONE	PVT	PVT	Wellbutran,Synthroid	NONE	Clinical depression,Hypothyroidism,right club foot, S/P, cortisone injection 10/21/98	UNK~ ()~~~In patient		1						1	Dizziness; Hypotension; Hypothermia; Nausea; Vasodilatation	FLU3~PFIZER\WYETH~4988204~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0115725	11/04/1998	KY	5.0	5		M	10/26/1998	Pt recv vax on 10/22/98; on 10/23/98 pt exp swelling at vax site, redness				Y					Y	10/22/1998	10/23/1998	1	UNK	PUB	PUB	Triotann BID; Allergy shots (2) LA, RA, 10/19/98	Morning allergies	Allergic to pollen, grass, trees, mold, mildew, cats, milk	UNK~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Rash; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4988204~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4988204~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0115727	11/04/1998	IL	63.0	63		F	10/08/1998	Pt recv vax on 10/5/98; on same day pt exp hives; tx=Prednisone				Y					Y	10/05/1998	10/05/1998	0	NONE	PUB	PUB	Uniphyll, Hemabid, Aerobid-Inhaler, Premarin, Tylenol, Darvocet, Valium	NONE	Iodine, IVP dye, Codeine, Talwin, Osteo-arthritis	UNK~ ()~~~In patient	IL98075	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~0975820~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0906E~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0115730	11/04/1998	CA	32.0	32		F	10/26/1998	11OCT98 sore throat & later morning rt ear ache-fluid in rt ear (started ATB 18OCT) x 8 days;13OCT generalized weakness, stomach pain, nausea;14OCT cont weakness/stomach pain;									Y	10/09/1998	10/11/1998	2		PUB	UNK		NONE	NONE	~ ()~~~In patient		1						1	Abdominal pain; Asthenia; Ear pain; Nausea; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~0977170~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115732	11/04/1998	MD	77.0	77		F	11/02/1998	rash, paleness, weakness, hoarseness, wheezing;tx w/med;									Y	10/09/1998	10/10/1998	1		UNK	UNK				~ ()~~~In patient		1						1	Asthenia; Asthma; Dysphonia; Pallor; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115733	11/04/1998	IN	37.0	37		M	10/26/1998	pt exp hives w/itching p/vax approx 1hr 15min;hives-face-neck, arms, abd, throat a little tight;DPH given;									Y	10/15/1998	10/15/1998	0	NONE	OTH	PVT		NONE	percocet	~ ()~~~In patient		1						1	Laryngospasm; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~0972870~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115736	11/04/1998	MI	43.0			F		pt felt numbness & tingling dow lt arm shortly p/remained redness & swelling devel area 4-5 long & 2-3 wide) by next day;took APAP & applied ice;devel some tightness in chest but thought it may be from stress;some soreness & weak feelings;													NONE	PUB	PUB		NONE	PCN & quivoron	~ ()~~~In patient		1						1	Asthenia; Chest pain; Injection site hypersensitivity; Injection site oedema; Myalgia; Paraesthesia	FLU3~PFIZER\WYETH~4988204~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~M0304H~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0115738	11/04/1998	MA	82.0	82		F	10/23/1998	20OCT98 early AM for several days erythema rt forearm below inj site;sl swelling inner elbow area-sl pruritus redness & swelling by 23OCT98 denies discomfort;									Y	10/19/1998	10/20/1998	1	NA	PUB	OTH	Premarin-Zestril;Prilosec	NONE	NKA-HBP	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Pruritus	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0304H~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0115739	11/04/1998	FL	56.0	56		F	10/27/1998	pt recv vax 13OCT & devel dizziness, itching, hives, red spots, some swelling & SOB lasted 4-5 days;didn't call to see a MD -2wk later called to report  rxn & advised to see MD;									Y	10/12/1998	10/13/1998	1	NONE	PUB	PUB		unk	unk	unk~ ()~~~In patient	FL98054	1						1	Dizziness; Dyspnoea; Oedema; Pruritus; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E20158HC~2~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0115740	11/04/1998	FL	80.0	80		M	10/27/1998	pt recv vax & reported 2 days later noted red spots, hives, itching, rash, no fever, knots on head;refused to see MD;									Y	10/22/1998	10/23/1998	1	NONE	PUB	PUB	unk	unk	unk	unk~ ()~~~In patient	FL98053	1						1	Pruritus; Rash; Skin nodule; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E20158HC~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0115743	11/04/1998	KS	43.0	43		F	11/03/1998	1 1/2 to 2 diameter  circle around inj;lump in center;hot to touch;very red;very itchy;started 24hr after;still red; same size, but starting to streak down arm;not as itchy & not hard lump;									N	10/28/1998	10/29/1998	1	NA	OTH	OTH	Diuretic;Synthroid, Procardia, Premarin, Stomach, ventolin, hydrocodone;oxycontin	cold	high blood pressure, low thyroid;hormone's;asthma	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Pruritus; Skin striae; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115746	11/04/1998	CA	68.0	68		M	10/26/1998	c/o pain @ inj site w/notable swelling from upper arm to elbow-onset approx 4hr p/vax;saw MD stated severe localized rxn;									Y	10/22/1998	10/22/1998	0	NONE	PUB	OTH		NONE	neuropathy (elavil) no other	NONE~ ()~~~In patient		1						1	Injection site oedema; Injection site pain; Injection site reaction	FLU3~MEDEVA PHARMA, LTD.~E20128GC~6~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0870H~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0115890	11/05/1998	MA	50.0	50		M	11/02/1998	cellulitis, fever, malaise went to Er 36hr later treated for severe cellulitis, put on ATB;				Y	Y	2			Y	10/27/1998	10/28/1998	1		PUB	PUB	NONE	NONE	no spleen, pancreatitis spring, no allergies	NONE~ ()~~~In patient	MA9814	1						1	Cellulitis; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0975780~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1541E~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0115892	11/05/1998	CO	42.0	41		F		11:05 reported feeling funny, site of shot inc redness;BP 168/92, 108, 26;11:10 adrenalin given BP 174/94, 116, 28;11:13 02 given c/o nausea;11:15 174/94, 104, 24;wheezing;tired;				Y						10/31/1998	10/31/1998	0		OTH	PVT		denied		~ ()~~~In patient		1						1	Asthma; Hypertension; Hyperventilation; Hypoxia; Injection site hypersensitivity; Malaise; Nausea; Tachycardia	FLU3~CONNAUGHT LABORATORIES~0984550~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0115896	11/05/1998	OH	55.0	55		F	10/16/1998	states rt arm became red & sore;became unable to move arm d/t pain;went to hosp ER;told infect in arm & given ATB;				Y					N	10/16/1998	10/17/1998	1	NOEn	PUB	UNK	Elavil;	NONE	ragweed, cats, grass, trees, harrington rods in back;	NONE~ ()~~~In patient		1						1	Hypokinesia; Infection; Myalgia; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0977170~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1452E~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0115900	11/05/1998	VA	55.0	55		F	10/26/1998	pt recv vax 22OCT98 3PM & that noc pt had chills;no fever;felt hot during noc;did not take temp;vomited x 1 23OCT98 & 25OCT98;nausea several days;									N	10/22/1998	10/22/1998	0	NONE	OTH	PUB	Lithium;Tegretol	NONe	bipoler diagnosis	NONE~ ()~~~In patient	VA98072	1						1	Chills; Nausea; Vasodilatation; Vomiting	FLU3~PFIZER\WYETH~4988212~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0115901	11/05/1998	CA	70.0	70		F	10/29/1998	very painful w/site of inj w/severe swell & redness;									Y	10/22/1998	10/22/1998	0	NOEn	PVT	PVT		NONE	prior tetanus-erythema;HTN/thalaosemial;	pt exp erythema @ 36yr old w/tetanus~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0977170~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115902	11/05/1998	IA	59.0	59		F	10/30/1998	awoke 30OCT AM w/sore rt arm;noted quarter area of redness @ site of pneumonia shot;area et swollen;area very tender;									Y	10/29/1998	10/30/1998	1	NONE	PUB	PUB	Cardizem, liptor, pepcid, ASA effevor, premarin, provera, clariton, vitamins;	NONE	NKA, NONE	NONE~ ()~~~In patient	IA98032	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0971390~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0871H~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0115903	11/05/1998	IL	10.0	10		F	10/30/1998	small, red, swollen area on rt arm on 28OCT98;pt recv vax 26OCT98;									Y	10/26/1998	10/28/1998	2		PVT	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PARKDALE PHARMACEUTICALS~03088P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0115904	11/05/1998	AR	84.0	84		F	11/02/1998	lt side numbness w/o other signs or sx;pt had never had flus hot until 1977 (this was second);pt still has numbness sin hand & face (12 days);pt had lt side face & tongue numbness, lt hadn't from wrist down;									N	10/08/1998	10/21/1998	13	carotid doppler nl	PVT	PVT	NONE	NONE	NONe	NONE~ ()~~~In patient		1						1	Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0967040~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115905	11/06/1998	CO	41.0	41		F	10/28/1998	pt recv vax 12OCT98 & 21OCT98 pt hosp w/dx of ITP;platelet count on admission was 2000;pt tx w/med;				Y	Y	17			Y	10/12/1998	10/21/1998	9	21OCT98 platelet count 2000	PVT	PUB	unk	NONE	non-insulin dependent diabetes mellitus	~ ()~~~In patient	898302053A	1						1	Thrombocytopenia; Thrombocytopenic purpura	FLU3~PFIZER\WYETH~4988247~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0115906	11/06/1998	MT	89.0	89		F	10/19/1998	pt recv vax 5OCT98 & that evening pt devel n/v & syncope;also devel severe swelling @ site of vax progressed into cellulitis;pt lt arm turned yellow from elbow to wrist;pt hosp;while in hosp vomited, aspirated the vomitus & devel pneumonia				Y	Y	2			Y	10/05/1998	10/05/1998	0		PUB	OTH	Zestoretic, thyroid supplement	NONE	HTN, asthma, thyroid problems, prev dose of pnu imune 23 administered in 1992;	~ ()~~~In patient	898294067A	1						1	Cellulitis; Injection site oedema; Pneumonia; Skin discolouration; Syncope; Vomiting; Pain; Syncope; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E20188HD~6~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~442522~2~IM~LA~PNEUMO (PNU-IMUNE)~1|FLU3~MEDEVA PHARMA, LTD.~E20188HD~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~PFIZER\WYETH~442522~2~IM~LA~PNEUMO (PNU-IMUNE)~2	USA	Hospitalisation	Influenza
0115907	11/06/1998	FL	70.0	69		M	11/03/1998	pt recv vax 15OCT96 & 20DEC96 pt noticed a decrease in hearing;24DEC96 pt was seen by MD & informed that there was a 95% decrease in hearing in the right ear & 20% decrease in hearing in the lt ear;poss of an inner ear infect;mild stuffines				Y				Y	N	10/15/1996	12/20/1996	66		UNK	UNK				~ ()~~~In patient	U199800755	1						1	Deafness permanent; Ear disorder; Infection	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0115908	11/06/1998	NY	45.0	45		M	10/26/1998	pt recv vax 21SEP98 & w/in 48hr pt exp deafness & a balance disturbance;sx persisted as of 26OCT98;									Y	09/21/1998	09/23/1998	2		OTH	OTH	unk	sinus infection	none	~ ()~~~In patient	898300025A	1						1	Coordination abnormal; Deafness; Dizziness; Tinnitus	FLU3~PFIZER\WYETH~4988212~UNK~A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0115909	11/06/1998	FL	65.0	65		M	10/28/1998	pt recv vax 22OCT98 & pt exp an arrest p/vax & had to be resuscitated;pt hosp			Y	Y	Y				U	10/22/1998	10/22/1998	0		UNK	UNK			resp insufficency & chronic obstructive pulmonary disease;	~ ()~~~In patient	U199800715	1						1	Cardiac arrest	FLU3~CONNAUGHT LABORATORIES~0984530~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0115910	11/06/1998	VA	61.0			M	11/04/1998	pt recv vax 29OCT98 & died post cardiac arrest;pt had no allergic or anaphylactic rxn immed to the vax;	Y									10/29/1998	10/29/1998	0		UNK	UNK			chronic renal failure	~ ()~~~In patient	U199800766	1						1	Cardiac arrest	FLU3~CONNAUGHT LABORATORIES~0981790~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0115912	11/06/1998	OH	52.0	52		F	10/30/1998	pt recv vax 28OCT98 4PM;taken to Er @ approx 6Pm w/sudden onset of chest discomfort;	Y	10/29/1998							N	10/28/1998	10/28/1998	0	unk	PUB	PUB		unk	unk	unk~ ()~~~In patient	FLU89161098	1						1	Apnoea; Cardiac arrest; Chest pain	FLU3~PARKDALE PHARMACEUTICALS~02298P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0115913	11/06/1998	MO	21.0	21		F	10/30/1998	pt recv vax 6-8AM & on 28OCT98 pt vomited 10min later felt bad;went home & cont c/o not feeling well next day;drove husband to work & when arrived in parking lot lost consciousness & stopped breathing;	Y	10/29/1998							N	10/28/1998	10/28/1998	0	drug toxicology drawn in ER;	OTH	PVT		unk	allergic to PCN		FLU89171098	1						1	Apnoea; Malaise; Myocarditis; Syncope; Vomiting; Unevaluable event	FLU3~PARKDALE PHARMACEUTICALS~021198P~2~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~02198P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Results in Death	Influenza
0115925	11/06/1998	SC	57.0	57		F	10/23/1998	3 diameter red area w/lump @ inj site rt arm;pt saw Md 23OCT98;was given ATB d/t hx of mastectomy;				Y					Y	10/20/1998	10/21/1998	1		PUB	PUB		NONE		~ ()~~~In patient	SC98061	1						1	Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~0980580~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~0960580~5~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0115928	11/06/1998	GA	40.0	40		F	10/06/1998	pt recv vax before noon, shortly p/lunch felt sick, tired, nausea, weak, upset tummy, lay down until about 430PM;hands started burning, itching then spread to whole body;devel whelps & hives;itched on hands, awoke off & on all noc;										10/05/1998	10/05/1998	0		PUB	PUB				~ ()~~~In patient	GA98095	1						1	Asthenia; Dyspepsia; Insomnia; Malaise; Nausea; Oedema peripheral; Pruritus; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E20148HD~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0115929	11/06/1998	FL	54.0	54		F	11/02/1998	6hr p/vax pt lt arm became swollen & red;also had diarrhea which started the next morning accompanied by low grade fever;										10/27/1998	10/27/1998	0	NA	PUB	PUB	Ziac	NONE	NONE	~ ()~~~In patient	FL98056	1						1	Diarrhoea; Oedema peripheral; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E20088GB~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0115930	11/06/1998	VA	41.0	41		F	10/29/1998	chills 915PM, sweats 110AM, localized redness;pt MD office stated these could be nl reactions;										10/28/1998	10/28/1998	0		PUB	UNK		NONE	NONE	NONE~ ()~~~In patient	VA98074	1						1	Chills; Hyperhidrosis; Injection site hypersensitivity	FLU3~PFIZER\WYETH~488212~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0115931	11/06/1998	IL	68.0	68		F	11/04/1998	could not lift arm;extreme pain;h/a, T102;fine, solid rash @ site of shot;spread down arm-had pneumonia shot in rt arm where pain & rash began;flu shot in lt-rash on this arm also;									Y	10/28/1998	10/28/1998	0	NONE	PUB	PUB		NONE	NONE	~ ()~~~In patient	IL98080	1						1	Headache; Hypokinesia; Injection site hypersensitivity; Injection site pain; Pain; Pyrexia; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~0985890~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1510E~2~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0115933	11/06/1998	OH	52.0	52		F	10/19/1998	pt recv vax 15OCT98 & hives started on both arms 16OCT98 @ 4PM;hives on abd, between legs, back, breast on 17OCT98;call MD 17OCT;recommended DPH & cortisone cream;rash getting better;									Y	10/15/1998	10/16/1998	1	NONE	PUB	PUB	Lotensor/BP, herbs	NONE	NONE	~ ()~~~In patient	OH98079	1						1	Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~0977170~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115934	11/06/1998	SC	63.0	63		F	10/26/1998	approx 8hr p/vax pt noticed swelling & soreness of lt upper arm;by next day swelling & soreness had moved down arm to elbow & now included redness;heat was applied w/some relief;redness & swelling (mild 4-5 from elbow;									N	10/23/1998	10/23/1998	0		PUB	UNK		NONE	currently seeing hematologist for low platelet count	~ ()~~~In patient	SC98060	1						1	Injection site oedema; Injection site pain; Myalgia; Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0981810~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~10944~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0115941	11/06/1998	NY	61.0	61		F	10/28/1998	swelling, redness & pain on motion 4hr p/vax;advised warm compresses, NSAIDS;										10/27/1998	10/27/1998	0	NONE	PVT	UNK	NA	NONE	NONE	~ ()~~~In patient		1						1	Oedema; Pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~449100~1~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0115611	11/09/1998	MI	42.0	42		F	10/31/1998	ears roaring tinnitus extremely sensitive hearing-hyperacusis the next morning upon waking;dizziness;primary MD referred to ENT MD dx meniere's disease brought on from flu shot vax;prescribed hydrochlorothiazide;								Y	N	10/12/1998	10/13/1998	1	ENT MD-ears examined, audiogram, hearing test, tympanogram	PUB	UNK	Elavil	NONE	fibromyalgia	NONE~ ()~~~In patient		1						2	Dizziness; Hyperacusis; Tinnitus; Dizziness; Hyperacusis; Tinnitus; Vestibular disorder	FLU3~PFIZER\WYETH~4988204~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Disabling	Influenza
0116053	11/09/1998	MA	49.0	49		F		2hr p/vax devel sore arm, 3hr p/vax devel resp problems which indicated some difficulty breathing & deep, raspy, non productive cough;by 5hr later felt throat swelling & inc resp distress;went to ER 7PM;felt like asthma;poss allerg react			Y	Y					Y	10/15/1998	10/15/1998	0		PUB	PUB	vitamins	NONE	case reports that 20yrs ago had allergy tsting that showed many environmental allergies on 21OCT;reported that testing 20yr ago showed allergy to eggs but did not report this;hx of asthma;	NONE~ ()~~~In patient		1						1	Anxiety; Asthma; Condition aggravated; Cough; Dyspnoea; Hypersensitivity; Laryngospasm; Myalgia; Respiratory disorder	FLU3~CONNAUGHT LABORATORIES~0975780~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0116054	11/09/1998	CA	0.9	0	.9	M		high fever for hr & wk p/ w/break through sz;adm to hosp for 3 days;fever persisted p/ now apparently recovered;				Y	Y				Y	10/15/1998	10/15/1998	0	CSF, blood cult, urine cult & viral panel all negative;	PVT	OTH	Vanceril, albuterol, pediazole	OM (resolving)	panhypopitutorism, arthritis, IUDE, sz			1						1	Arthralgia; Cerebrovascular disorder; Condition aggravated; Convulsion; Neoplasm; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0981820~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0043H~3~~LL~HEP B (RECOMBIVAX HB)~1	USA	Hospitalisation	Influenza
0116057	11/09/1998	GA	49.0	49		M	10/09/1998	pt recv vax 3NOV95 & reports devel GBS;pt hosp for numbness in fingers & toes;referred to MD;				Y	Y	10		Y	N	11/03/1995	11/07/1995	4		PUB	PUB		emphysema	emphysema	~ ()~~~In patient	GA98079	1						1	Guillain-Barre syndrome; Paraesthesia	FLU3~PFIZER\WYETH~4958107~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0116059	11/09/1998	IN	14.0	14		M	11/05/1998	rt deltoid became red Friday evening Saturday 17OCT98, arm worse, T103.6 ear;seen by MD 19OCT98 w/6 long x 3 1/2 wide are of cellulitis @ inj site;med given;2NOV98 had croupy cough & fever seen MD dx pneumonia placed on cefzil;				Y					Y	10/16/1998	10/16/1998	0	NONE	PUB	PUB	Lanoxin;aldactone;Lasix;Inderal;	NONE	hypoplastic lt heart synd;double outlet rt ventricle pulmonary stenosis, immunodeficiency missing subclass IV	pt exp fever 104, excessive crying @ 2mo w/DTP dose 2;sibling exp same @ 6mo w/3~ ()~~~In patient		1						1	Cellulitis; Cough; Dyspnoea; Injection site hypersensitivity; Laryngitis; Pneumonia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0974000~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454956~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0116061	11/09/1998	NC	82.0	82		F	10/27/1998	diffuse hives, swelling of lips;				Y						10/19/1998	10/26/1998	7	NONE	PVT	PVT		NONE	HTN, hypothyoidismy, inc cholesterol	~ ()~~~In patient		1						1	Face oedema; Urticaria	FLU3~CONNAUGHT LABORATORIES~0984610~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116064	11/09/1998	CA	27.0	27		F	11/06/1998	nausea, diarrhea, fever also following vaccine congestion, light sensitivity, h/a, runny nose;									U	10/22/1998	10/27/1998	5		PVT	PVT	Triphasil 28 BC	NONE	NONE	~ ()~~~In patient		1						1	Diarrhoea; Headache; Nausea; Pharyngitis; Photosensitivity reaction; Pyrexia; Rhinitis	FLU3~PARKDALE PHARMACEUTICALS~02988P~1~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116066	11/09/1998	MA	79.0	79		F	10/29/1998	rt arm paralyzed for 2 days p/vax;high level of pain, could not lift arm, OTc meds relieve the pain;have appt w/MD;				Y					N	10/05/1998	10/05/1998	0		UNK	UNK			daibetic	~ ()~~~In patient		1						1	Hypokinesia; Pain; Paralysis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0116067	11/09/1998	NJ	76.0	76		M	10/31/1998	allergic rxn w/hives & swelling of face so far it is 10 days & still have hives;had 21 steroid pills dec DPH pills & zyrtec pills				Y					N	10/21/1998	10/22/1998	1	NONE	PUB	OTH	Lotensin & enduron	NONE	NONE	NONE~ ()~~~In patient		1						1	Face oedema; Hypersensitivity; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0116090	11/09/1998	GA	60.0	60		F	10/08/1998	about 3hr p/vax tenderness on rt side of head & trouble swallowing BP inc also rash on lt arm w/itching;advised to call PMD about tender, head & difficulty swallowing;									U	10/07/1998	10/07/1998	0	NONE	PUB	PUB	Ativan, BP med	NONE	inc BP	NONE~ ()~~~In patient	GA98088	1						1	Dysphagia; Headache; Hypertension; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~0975850~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116091	11/09/1998	GA	56.0	56		F	10/08/1998	c/o tenderness, redness & swelling @ inj site;									U	10/07/1998	10/08/1998	1	NA	PUB	UNK			h/o asplenia-got repeat provac @ pt request	NONE~ ()~~~In patient	GA98089	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~097580~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~444073M~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0116093	11/09/1998	MO	41.0	41		F	10/27/1998	2 days p/vax pt exp deep, aching pain in lt deltoid muscle;states pain in from lt shoulder to lt elbow;pt states has difficulty lifting w/lt arm now;									N	10/16/1998	10/18/1998	2		PUB	PUB	unk	NONE	unk	~ ()~~~In patient	MO98068	1						1	Hypokinesia; Injection site pain; Myalgia	FLU3~CONNAUGHT LABORATORIES~0984540~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~0967100~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0116097	11/09/1998	TN	87.0	87		F	10/23/1998	rt arm deltoid area shows large area of erythema & warmth to touch;									Y	10/20/1998	10/22/1998	2	NONE	PVT	PVT	Prinival, dyazide, advil, evista	HTN, dementia, bilat carpal tunnel	NKDA	~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20208HB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~PFIZER\WYETH~4978240~2~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0116098	11/09/1998	DC	50.0	50		M	10/26/1998	malaise, muscle aches, chills, fever 99.1-101;										10/22/1998	10/25/1998	3	NONE	PUB	PUB	NONE	NA	allergic to ragweed, pollen, trees, grass	NA~ ()~~~In patient	DC9801	1						1	Malaise; Myalgia; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E201186A~1~IM A~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0116099	11/09/1998	VA	33.0	33		F	10/30/1998	pt recv vax 29OCT98 & returned to clinic 30OCT98 to report site of inj left deltoid, swollen area, hard to touch measures 7cm x 9cm;pt also c/o itching @ site of inj;									U	10/29/1998	10/30/1998	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	VA98078	1						1	Injection site mass; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4988212~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116101	11/09/1998	MN	56.0	56		M	10/30/1998	h/a, breathing difficulty, pounding heart;									U	10/24/1998	10/25/1998	1		OTH	PVT		NONE	NONE	NONE~ ()~~~In patient		1						1	Dyspnoea; Headache; Tachycardia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116103	11/09/1998	MN	51.0	51		F	11/01/1998	4hr p/vax very tired;8hr faint, nausea, chills, fever, diff breathing, ache all over;24hr nausea, fever, ache all over;p/6 days sx passed;ASA, bed rest, lots of  fluids;									Y	10/21/1998	10/21/1998	0		OTH	OTH	premarin;tagamet	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Dizziness; Dyspnoea; Myalgia; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116104	11/09/1998	AZ	44.0	44		F	10/21/1998	approx 1hr p/vax pt devel h/a followed by fever 101 & myalgias, arthralgia, diarrhea began 16hr post vax;currently breast feeding;									Y	10/20/1998	10/20/1998	0	NONE	PVT	PVT	APAP;multvitamins	NONe	hayfeer	pt exp n/v/d, fever @ age 5 w/mult vax~ ()~~~In patient		1						1	Arthralgia; Diarrhoea; Headache; Myalgia; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~02298P~2~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116110	11/09/1998	ME	54.0	54		F	11/04/1998	intense itching from the neck up & especially the top of ears;sx began day of vax & persisted @ least until called 6 days later;advised to take DPH;									U	10/27/1998	10/29/1998	2	NONE	MIL	PVT				~ ()~~~In patient		1						1	Ear disorder; Pruritus	FLU3~PFIZER\WYETH~02298P~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116111	11/09/1998	OH	50.0	50		M	11/05/1998	21OCT98 pt c/o joint & muscle ache & h/a;23OCT ankles edematous;25OCt severe edema of ankles w/blisters on calves, red raised areas on heels;size of fingernail, ankles red & inflamed;saw MD & was given cortisone & medrol pack;									U	10/16/1998	10/21/1998	5	lab CBC, sed rate, chem-nl;	OTH	PVT						1						1	Arthralgia; Dermatitis bullous; Headache; Myalgia; Oedema peripheral; Rash maculo-papular; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0983290~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116112	11/09/1998	NY	58.0	58		M	10/28/1998	severe throbbing h/a, eyes feeling like they are popping of head, vertigo, sore on standing bilat myalgia of shoulders;									U	10/27/1998	10/27/1998	0	NONE	PVT	PVT	NONE	NONE	PCN allergy	~ ()~~~In patient		1						1	Eye disorder; Headache; Myalgia; Vertigo	FLU3~MEDEVA PHARMA, LTD.~E20228KB~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0116113	11/09/1998	SC	76.0	76		F	10/29/1998	pt had rxn to vax pt reported running a fever & chills the noc of vax & took APAP all noc & day;rt arm red about size of baseball & warm to touch;									Y	10/27/1998	10/28/1998	1		PUB	PUB		NONE	NONE	~ ()~~~In patient	SC98064	1						1	Injection site hypersensitivity; Injection site mass; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0980580~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0871H~2~SC~RA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~0950740~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0116115	11/09/1998	WI	42.0	42		F	10/30/1998	pt woke up 7AM w/edema of lt side of face, did nothing subsided by noon on own & restarted 30OCT98 & has not subsided;									Y	10/28/1998	10/29/1998	1	NONE	PUB	PUB	NONE	NONE	amoxicillin, tetracycline	~ ()~~~In patient	WI98058	1						1	Face oedema	FLU3~PFIZER\WYETH~4988222~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116117	11/09/1998	MO	39.0	39		M	10/27/1998	pt noticed redness p/a shower 8PM;redness & soreness have diminished but itching & hardness in area persist;									Y	10/23/1998	10/23/1998	0	NONE	OTH	PUB		NONE		~ ()~~~In patient	MO98066	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~0983310~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116301	11/09/1998	FL	80.0	80		F	10/14/1998	Pt recv vax on 9/30/98; on same day pt exp muscle pain, stomach pain, fever, dark urine, diarrhea									Y	09/30/1998	09/30/1998	0	UNK	PVT	PVT	UNK	UNK	UNK	UNK~ ()~~~In patient	FLU88071098	1						1	Abdominal pain; Diarrhoea; Myalgia; Pyrexia; Urine analysis abnormal	FLU3~PARKDALE PHARMACEUTICALS~03788P~2~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116302	11/09/1998	WI	38.0	38		F	10/08/1998	Pt recv vax on 10/7/98; on 10/8/98 pt exp indurated & warm rx on LA									Y	10/07/1998	10/08/1998	1	UNK	PVT	OTH	Claritin D, Zoloft	NONE	NONE	UNK~ ()~~~In patient	FLU88081098	1						1	Injection site mass; Injection site oedema; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~03088P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116303	11/09/1998	WI	41.0	41		F	10/08/1998	Pt recv vax on 10/7/98; on 10/8/98 pt exp indurated & warm LA									Y	10/07/1998	10/08/1998	1	UNK	PVT	OTH	Insulin, Zoran, Synthroid, Furosemide, Vitamin E	NONE	Diabetes, high blood pressure, high cholesterol ( All under control)	UNK~ ()~~~In patient	FLU88091098	1						1	Injection site mass; Injection site oedema; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~03088P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116304	11/09/1998	WI	54.0	54		F	10/12/1998	Pt recv vax on 10/7/98; on 10/8/98 pt exp indurated & warm rx on LA									Y	10/07/1998	10/08/1998	1	UNK	OTH	OTH	TB skin test-248311 RA 9/16/98	Start of cold	Asthma-environment, seasonal, exercised induced	Pt exp rx to Tetanus vax 9/11/98 #1 dose~ ()~~~In patient	FLU88101098	1						1	Injection site mass; Injection site oedema; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~03088P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116305	11/09/1998	WI	0.3	0	.3	F	10/08/1998	Pt recv vax on 10/7/98; 7 hr later pt exp indurated & warm rx on Rt arm									Y	10/07/1998	10/07/1998	0	UNK	PVT	OTH	TB skin test-9/16/98-248311 RA #2 dose; Claritin, Albuterol, Ulra,Norynel	NONE	Allergic to Codeine, Penicillin, Darvocet, Anaphylactic	UNK~ ()~~~In patient	FLU88111098	1						1	Injection site mass; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~03088P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116306	11/09/1998	VT	56.0	56		F	10/15/1998	Pt recv vax on 10/13/98; post vax pt exp increased cough, tight chest, red/puffy eyes & difficulty breathing				Y					Y	10/13/1998	10/13/1998	0	UNK	PVT	PVT	UNK	UNK	UNK	UNK~ ()~~~In patient	FLU88121098	1						1	Chest pain; Conjunctivitis; Cough; Dyspnoea; Face oedema	FLU3~PARKDALE PHARMACEUTICALS~02298P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0116307	11/09/1998	VT	37.0	37		F	10/15/1998	Pt recv vax on 10/14/98; post vax pt exp tight throat, hoarse, red blotches on neck & chest				Y					Y	10/14/1998	10/14/1998	0	UNK	PVT	PVT	UNK	UNK	UNK	UNK~ ()~~~In patient	FLU88131098	1						1	Dysphonia; Laryngospasm; Rash maculo-papular	FLU3~PARKDALE PHARMACEUTICALS~02298P~2~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0116308	11/09/1998	PA	1.2	1	.2	F	10/14/1998	Pt recv vax on 10/12/98; the wrong dosage was given; no adverse rx									Y	10/12/1998	10/12/1998	0	UNK	PVT	PVT	UNK	NONE	UNK	NONE~ ()~~~In patient	FLU88141098	1						1	Unevaluable event	FLU3~PARKDALE PHARMACEUTICALS~02198P~1~IM~LL~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116309	11/09/1998	MO	72.0	72		M	10/13/1998	Pt recv vax on 10/8/98; on 10/9/98 pt exp nausea									Y	10/08/1998	10/09/1998	1	UNK	PVT	OTH	NONE	UNK	NONE	UNK~ ()~~~In patient	FLU88151098	1						1	Nausea	FLU3~PARKDALE PHARMACEUTICALS~02198P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116310	11/09/1998	MO	26.0	26		F	10/13/1998	Pt recv vax on 10/8/98; on 10/9/98 pt exp nausea & vomiting									Y	10/08/1998	10/09/1998	1	NONE	PVT	PVT	NONE	UNK	NONE	UNK~ ()~~~In patient	FLU88161098	1						1	Nausea; Vomiting	FLU3~PARKDALE PHARMACEUTICALS~02198P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116311	11/09/1998	MO	59.0	59		F	10/14/1998	Pt recv vax on 10/9/98; on 10/10/98 pt exp nausea & vomiting									Y	10/09/1998	10/10/1998	1	NONE	OTH	PVT	UNK	UNK	UNK	UNK~ ()~~~In patient	FLU88171098	1						1	Nausea; Vomiting	FLU3~PARKDALE PHARMACEUTICALS~02198P~1~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116312	11/09/1998	IL	33.0	33		F	10/14/1998	Pt recv vax on 10/10/98; on same day pt exp nausea & vomiting									Y	10/10/1998	10/10/1998	0	NONE	OTH	PVT	NONE	UNK	NONE	UNK~ ()~~~In patient	FLU88181095	1						1	Nausea; Vomiting	FLU3~PARKDALE PHARMACEUTICALS~02198P~1~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116313	11/09/1998	MO	32.0			F	10/14/1998	Pt recv vax on 10/9/98; on 10/10/98 pt exp nausea & vomiting									Y	10/09/1998	10/10/1998	1	NONE	OTH	PVT	NONE	UNK	NONE	UNK~ ()~~~In patient	FLU88191098	1						1	Nausea; Vomiting	FLU3~PARKDALE PHARMACEUTICALS~02198P~1~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116314	11/09/1998	MO	36.0	36		F	10/13/1998	Pt recv vax on 10/9/98; on 10/11/98 pt exp nausea & vomiting									Y	10/09/1998	10/11/1998	2	UNK	OTH	PVT	NONE	UNK	NONE	UNK~ ()~~~In patient	FLU88201098	1						1	Nausea; Vomiting	FLU3~PARKDALE PHARMACEUTICALS~02198P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116315	11/09/1998	NY	73.0	73		M	10/21/1998	Pt recv vax on 9/17/98; on same day pt exp hypoglycemia sxs of cold, sweats & near syncope				Y					Y	09/17/1998	09/17/1998	0	UNK	PVT	PVT	Coumadin, Synthroid, Verampamil	NONE	NONE	NONE~ ()~~~In patient	FLU88241098	1						1	Chills; Hyperhidrosis; Hypoglycaemia; Syncope	FLU3~PARKDALE PHARMACEUTICALS~02988P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0116316	11/09/1998	CO	70.0	70		F	10/19/1998	Pt recv vax on 10/15/98; on 10/16/98 pt exp round/swollen/erythematous/ warm/ pruritic lesion  at vax site				Y					Y	10/15/1998	10/16/1998	1	UNK	PVT	PVT	Lotensin, Fosamax	NONE	Allergic to Demoral	UNK~ ()~~~In patient	FLU89011098	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02198P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0116317	11/09/1998	CO	33.0	33		F	10/21/1998	Pt recv vax on 10/14/98; on same day pt exp round, swollen, erythematous, warm rx at vax site; pruritic & wheezing				Y					Y	10/14/1998	10/14/1998	0	UNK	PVT	PVT	UNK	NONE	Asthma	NONE~ ()~~~In patient	FLU89021098	1						1	Asthma; Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02198P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0116318	11/09/1998	OH	52.0	52		F	10/22/1998	Pt recv vax on 10/19/98; on same day pt exp arm ache, fatigue, bone aches, dizzy; pt imp 30 hr									Y	10/19/1998	10/19/1998	0	NONE	PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	FLU89031098	1						1	Asthenia; Dizziness; Myalgia; Pain	FLU3~PARKDALE PHARMACEUTICALS~02298P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116319	11/09/1998	MN	0.8	0	.8	M	10/22/1998	Pt recv vax on 10/22/98; pt given incorrect dosage (.5cc rather than .25cc)									Y	10/22/1998	10/22/1998	0	NONE	PVT	PVT	UNK	NONE	NONE	NONE~ ()~~~In patient	FLU89041098	1						1	Unevaluable event	FLU3~PARKDALE PHARMACEUTICALS~02788P~1~IM~RL~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~SMITHKLINE BEECHAM~2712A2~3~IM~LL~HEP B (ENGERIX-B)~1	USA		Influenza
0116320	11/09/1998	NJ	20.0			F	10/23/1998	Pt recv vax on 10/19/98; Pt may have recv vax IV instead of IM; no adverse rx									Y	10/19/1998			NONE	OTH	OTH	UNK	NONE	Allergic to Codeine	NONE~ ()~~~In patient	FLU89051098	1						1	Unevaluable event	FLU3~PARKDALE PHARMACEUTICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116321	11/09/1998	MN	36.0	36		F	10/23/1998	Pt recv vax on 10/21/98; 2 hr post vax pt exp dizziness, elevated blood pressure, rushing feeling, crawling skin,									Y	10/21/1998	10/21/1998	0	Blood pressure 160/100	OTH	OTH	UNK	NONE	NONE	NONE~ ()~~~In patient	FLU89061098	1						1	Dizziness; Hypertension; Skin disorder	FLU3~PARKDALE PHARMACEUTICALS~PD02788P~2~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116322	11/09/1998	NJ	45.0	45		F	10/23/1998	Pt recv vax on 10/21/98; 2 hr post vax pt exp difficulty swallowing, red/burning eyes, headache, joint pain; pt imp 24 hr									Y	10/21/1998	10/21/1998	0	NONE	PVT	OTH	UNK	NONE	NONE	NONE~ ()~~~In patient	FLU89091098	1						1	Arthralgia; Conjunctivitis; Dysphagia; Eye pain; Headache	FLU3~PARKDALE PHARMACEUTICALS~02298P~1~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116323	11/09/1998	OH	43.0	43		F	10/23/1998	Pt recv vax on 10/16/98; 4 hr post vax pt exp nausea, fatigue, limb soreness & headache									Y	10/16/1998	10/16/1998	0	UNK	PUB	OTH	UNK	NONE	NONE	NONE~ ()~~~In patient	FLU89101098	1						1	Arthralgia; Asthenia; Headache; Myalgia; Nausea	FLU3~PARKDALE PHARMACEUTICALS~02298P~7+~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116324	11/09/1998	OH	43.0	43		F	10/23/1998	Pt recv vax on 10/16/98; on 10/18/98 pt exp diarrhea, dizziness x 24 hr									Y	10/16/1998	10/18/1998	2	UNK	PUB	OTH	UNK	NONE	NONE	NONE~ ()~~~In patient	FLU89111098	1						1	Diarrhoea; Dizziness	FLU3~PARKDALE PHARMACEUTICALS~02298P~2~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116325	11/09/1998	NJ	47.0	47		F	10/27/1998	Pt recv vax on 10/21/98; on same day pt exp headache, burning eyes, nausea, woozy; dx=conjunctivitis of both eyes									U	10/21/1998	10/21/1998	0	NONE	PVT	OTH	UNK	NONE	NONE	NONE~ ()~~~In patient	FLU89141098	1						1	Conjunctivitis; Dizziness; Eye pain; Headache; Nausea	FLU3~PARKDALE PHARMACEUTICALS~~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0115593	11/10/1998	MN				M	10/26/1998	tonic clonic sz 1 day p/vax;?anecdotal;										10/23/1998	10/24/1998	1	nl glucose, eleytes, Ca#, Mg++, CBC;EEG scheduled;	UNK	UNK	Ritalin		Tobaco;no hx sz d/o;	~ ()~~~In patient		1						2	Acidosis; Convulsion; Hypertonia; Hypotonia; Convulsion; Convulsion	FLU3~PARKDALE PHARMACEUTICALS~02298P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~02298D~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~2|FLUX~UNKNOWN MANUFACTURER~02298D~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA		Influenza
0116120	11/10/1998	HI	78.0	78		F	11/04/1998	anaphylactic shock;			Y		Y					10/30/1998	10/30/1998	0		UNK	UNK	NONE		NKA	~ ()~~~In patient	FLU89231198	1						1	Anaphylactoid reaction	FLU3~PARKDALE PHARMACEUTICALS~02988P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation	Influenza
0116121	11/10/1998	FL	65.0	65		M	10/29/1998	resp distress following inj of flu vax;adm to hosp for 24hr;			Y	Y	Y	1			Y	10/22/1998	10/22/1998	0		PVT	PVT	Serevent MDI, Allopurinol	COPD, asthma	respiratory insufficiency and COPD	~ ()~~~In patient		1						1	Anaphylactoid reaction; Apnoea; Asthma; Cardiac arrest	FLU3~CONNAUGHT LABORATORIES~0984350~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0116122	11/10/1998	HI	51.0			F	11/04/1998	severe rash, erythema & edema, localized reaction;				Y							10/22/1998			UNK	UNK	NONE		allergic to PCN	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PARKDALE PHARMACEUTICALS~02988P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0116123	11/10/1998	HI	68.0			F	11/04/1998	severe local reaction (erythema, edema) to flu vax;				Y						10/20/1998	10/20/1998	0		UNK	UNK	Pneumovax;DT		known to be allergist;bastings, valium, PCN	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PARKDALE PHARMACEUTICALS~02988P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0116125	11/10/1998		24.0	24		M	10/21/1998	pt recv vax & exp large swelling from the site of inj down to mid forearm;redness from site of inj down to the elbow;pt given med;pt was adm to hosp on 20OCT98;inj site erythema, 1-5cm diameter mild tenderness w/in24hr;				Y	Y	1			Y	10/16/1998	10/17/1998	1		OTH	MIL	NONE	NONE	NONE			1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	ANTH~MICHIGAN DEPT PUB HLTH~FAV017~3~SC~LA~ANTHRAX (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4988247~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0116127	11/10/1998	NY	3.0	3		M	11/06/1998	30SEP98 exp malaise, abd complaints, sleepiness;taken to ER dx benign rxn to flu vax;taken home later devel vomiting;mom found child unresponsive taken back to ER;child pronounced in ER;autopsy had acute hemorrhagic pancreatitis;	Y	10/01/1998							N	09/29/1998	09/30/1998	1	SEP98  CD4 count 1400 & viral load test of approx 8000;amylase 2125;blood lipase >8000;autopsy included extensive microscopic studies;tissue stains yielded no organisms;brain examined by neuropathologist & found to be free of any AIDS;	UNK	UNK	Stavudine;Videx liquid		cogenital HIV+ from mother @ birth;never developed AIDS fefining illness;NKDA;followed by immunologist;	~ ()~~~In patient		1						1	Abdominal pain; Blood amylase increased; Infection; Laboratory test abnormal; Pancreatitis haemorrhagic; Somnolence; Stupor; Vomiting; Abdominal pain; Apnoea; Blood amylase increased; Coma; Convulsion; Enzyme abnormality; HIV infection; Pancreatitis haemorrhagic; Pharyngitis; Somnolence; Syncope	FLU3~PFIZER\WYETH~4988207~2~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4988207~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Results in Death	Influenza
0116128	11/10/1998	CA	64.0	64		F	11/04/1998	GBS on ventilator;			Y		Y				N	10/10/1998	10/26/1998	16		PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Guillain-Barre syndrome; Lung disorder	FLU3~CONNAUGHT LABORATORIES~02098P1~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0116129	11/10/1998	IA	61.0	61		F	10/26/1998	4hr p/vax tightening of throat;hoarse dry cough;DPH given;pt is RN & recognized sx;			Y						Y	10/26/1998	10/26/1998	0		PVT	PVT	NONE	anaphylaxis	NA	NA~ ()~~~In patient		1						1	Cough; Laryngitis; Laryngospasm	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0116133	11/10/1998	CA	89.0	88		M	11/03/1998	throatiness to voice, fever & became non ambulatory & like in coma on 3rd day;					Y	7			Y	10/20/1998	10/20/1998	0		OTH	PVT	Thyroid	NONE	alzheimer's disease	~ ()~~~In patient		1						1	Coma; Hypokinesia; Laryngitis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0116136	11/10/1998	NY	75.0	75		M	10/15/1998	Pt recv vax on 10/14/98; 1/2 hr later pt exp hives, no voice, swollen hands, swollen eyes, swollen tongue, swollen lips & itching; tx=Prednisone & Epinephrine				Y					Y	10/14/1998	10/14/1998	0		PVT	PVT	NONE	NONE	NKA	UNK~ ()~~~In patient		1						1	Face oedema; Laryngitis; Oedema peripheral; Tongue oedema; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E20178HB~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0116137	11/10/1998	MO	48.0	48		F	11/05/1998	Pt recv vax on 10/20/98; on 10/21/98 pt exp fever (101.8 PO); pt seen by M.D.-tx=Medrol Dose Pack;exp swollen, red, hot Rt arm x 4dy				Y					Y	10/20/1998	10/21/1998	1	NONE	OTH	PVT	Estrace, Synthroid	NONE	Allergic to Penicillin & Sulfa	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Malaise; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0978710~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~454956~1~IM~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0116138	11/10/1998	KS	41.0	41		F	11/05/1998	Pt recv vax on 10/20/98; on 10/21/98 pt exp red, hot, swollen  & sore vax site w/ streaks( Rt arm);tx=Relafen & heat				Y					Y	10/20/1998	10/21/1998	1	NONE	OTH	PVT	Prilosec, Prozac	NONE	Food allergies & stomach hyperacidity	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Oedema peripheral; Skin striae; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0978710~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~454956~1~IM~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0116139	11/10/1998	AZ	32.0	32		F	11/05/1998	Pt recv vax on 10/29/98; post vax pt exp shortness of breath, flushing, nausea, clutching throat & cough				Y					Y	10/29/1998	10/29/1998	0	UNK	OTH	OTH	Lamisil, Depo Provera	NONE	Bee sting & Sulfa allergy	UNK~ ()~~~In patient		1						1	Cough; Dizziness; Dyspnoea; Laryngospasm; Nausea; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20088GA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0116141	11/10/1998	TX	76.0	76		M	11/04/1998	Pt recv vax on 10/21/98; on same day pt exp vomiting & illness; pt seen in E.R.				Y					U	10/21/1998	10/21/1998	0	Work up at Baylor Univ. Hospital-negative	PVT	PVT	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Malaise; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E20258KC~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0116145	11/10/1998	CO	76.0	76		M	11/06/1998	Pt recv vax on 10/23/98; 5 min later pt exp shaking chills & myalgia, fever (104)				Y					Y	10/23/1998	10/23/1998	0	Chest X-ray, CBC, labs-normal	PVT	PVT	Insotec,Lenoxin,Lasix,ASA,Deporit,Coumadin,Ativar	NONE	CHS, CAD, colon avesceted, CHR, A Rib, pre MI	~ ()~~~In patient		1						1	Chills; Myalgia; Pyrexia; Tremor	FLU3~CONNAUGHT LABORATORIES~0977180~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454979~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0116148	11/10/1998	MO	75.0	75		F	11/02/1998	Pt recv vax on 10/21/98; 1 hr post vax pt exp painful arm w/ redness, swelling, fever; dx=blood poison, tx=Dexamethasone, Ciphril				Y					Y	10/21/1998	10/21/1998	0	NONE	OTH	OTH	Ogen, Natolon, Dorbask, Chromagen	NONE	Scholeosis, parosis	UNK~ ()~~~In patient		1						1	Malaise; Oedema peripheral; Pain; Rash; Skin nodule; Vasodilatation; Malaise; Oedema peripheral; Pain; Skin nodule; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1246H~UNK~~RA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~1246H~UNK~~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0116150	11/10/1998	OR	46.0	46		F	11/04/1998	Pt recv vax on 10/7/98; on 10/15/98 pt exp Rt arm numbness & weakness; dx=Parsonage Turner syndrome, mild arthritis/tendonitis				Y					N	10/07/1998	10/15/1998	8	M.R.I.-negative	PVT	PUB	Deperdal,Paxil,Atenolal,Premarin,Gogentin,Reglin,Moxitain	NONE	Amoxicillin, Hypertension	UNK~ ()~~~In patient		1						1	Arthritis; Depressed level of consciousness; Myasthenic syndrome; Neuralgia; Paraesthesia; Stupor; Tendon disorder	FLU3~CONNAUGHT LABORATORIES~0969610~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116152	11/10/1998	SD	19.0	19		M	10/30/1998	435PM palms of hands, red blotchy color, swelling of hands, sl itching, feeling of tightness of hands;no temp;5PM given DPH prescribed PDH;				Y					Y	10/28/1998	10/28/1998	0	NA	OTH	PVT	NovalinN insulin;novalin R insulin	NONE	insulin dependent diabetes;	NONE~ ()~~~In patient		1						1	Oedema peripheral; Pruritus; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20248KA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0116156	11/10/1998	UT	48.0			F		devel neuropathy (parasthesias) one leg w/in 24hr;progressed slowly to mild weakness, parasthesias arm;w/in 1wk all extremities involved;sent to neurologist;				Y					U	10/20/1998	10/21/1998	1	MRI, Lp	MIL	UNK	estrogen	NONE	NONE	NON~ ()~~~In patient		1						1	Myasthenic syndrome; Neuropathy; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E20238KD~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0116158	11/10/1998	CO	54.0	54		F	11/04/1998	asthma sx reported later that evening p/vax;no upper airway edema or chest pain;recv proventil via HHN @ walk in clinic that evening;the next day 4NOV98 stated asthma fine today;				Y					Y	11/03/1998	11/03/1998	0	NA	PVT	PVT	NONE	NONe	allergies PCN, sulfa, stated was told shouldn't eat shrimp because its high in mercury;p/face shared hx of asthma;	NONE~ ()~~~In patient		1						1	Asthma	FLU3~CONNAUGHT LABORATORIES~0973970~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116160	11/10/1998	WA	86.0	86		F	11/03/1998	pt c/o 3 days later painful to move lt shoulder;dx bursitis;pt saw ER provider & was told inj given to high;				Y					Y	10/19/1998	10/22/1998	3	unk	OTH	OTH	Levothyroxine	unk	unk	~ ()~~~In patient		1						1	Bursitis; Myalgia	FLU3~CONNAUGHT LABORATORIES~4988203~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116177	11/10/1998	WA	52.0	52		F	10/15/1998	rt arm swollen, breast swollen, red rings around rt arm almost down in armpit;had a h/a 14OCT98;sick to stomach;pt called clinic no one there;									Y	10/13/1998	10/14/1998	1		PUB	UNK		NONE		~ ()~~~In patient	WA981499	1						1	Dyspepsia; Headache; Lymphadenopathy; Oedema; Oedema peripheral; Skin striae	FLU3~CONNAUGHT LABORATORIES~0975810~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454960~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0116178	11/10/1998	CA	39.0	39		F	11/02/1998	1 1/2 x 3 reddened site, warm & inflamed;bruised @ site 1/2 x 1/2 induration 1 1/2 x 3;fatigued x 2 days;inflammation x 3 days;									Y	10/30/1998	10/30/1998	0	NONE	PUB	UNK	NONE		NKA	~ ()~~~In patient		1						1	Asthenia; Ecchymosis; Injection site hypersensitivity; Injection site inflammation; Injection site mass; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20298LA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0116180	11/10/1998	IA	59.0	59		F	11/04/1998	inj site sl swollen/red (size tennis ball) pea size hive @ needle entry-itching started w/in 4-5hr p/vax; 4NOV98 sx subsiding;									Y	11/02/1998	11/02/1998	0		PUB	PUB	OTC vitamins	NONE	PCN, latex?	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pruritus	FLU3~CONNAUGHT LABORATORIES~0971390~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116183	11/10/1998	OH	6.0	6		F	11/04/1998	myositis-ck 170 (nl 30-170);? GBS;weak muscles-legs & fever;									U	10/28/1998	11/01/1998	4		PVT	PVT	NONE	NONE	mild resp allergies/asthma	~ ()~~~In patient		1						1	Guillain-Barre syndrome; Myasthenic syndrome; Myositis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0981800~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116185	11/10/1998	LA	51.0	51		F	10/29/1998	itching over face & trunk & lt arm;mild urticaria below inj site;no wheezing;11AM BP 140/70;DPH given;1120AM BP 128/74 itching less no rash no wheezing;1140sx cleared;									Y	10/29/1998	10/29/1998	0	NONE	UNK	UNK	NONE	NONE	post CVA	NONE~ ()~~~In patient	LA981104	1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~0988270~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116186	11/10/1998	KS	58.0	58		F	11/06/1998	flu sx, vomit, diarrhea, fever, weakness, aching muscles;									N	11/03/1998	11/05/1998	2	NONe	PUB	PUB	THyroxin;Depacoat;Estorgen	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Diarrhoea; Influenza; Myalgia; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116187	11/10/1998	MS	48.0	48		F	11/06/1998	aching all over, wheezing, having trouble taking deep breath, eyes very blood shot, chills, fever, vomit (mucus), watery stools, yellow mucus, sticky in eyes;									Y	11/05/1998	11/05/1998	0	NOEn	OTH	OTH	vasotech;Estrogen	NONE	high BP	~ ()~~~In patient		1						1	Asthma; Conjunctivitis; Diarrhoea; Dyspnoea; Lacrimal disorder; Myalgia; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116188	11/10/1998	TX	41.0	41		F	11/05/1998	hives, on upper body chest, arms & neck;									N	11/05/1998	11/05/1998	0	NONe	OTH	OTH	Accutain;Intex;Depormine;zoloft	NONe	ADd, adult acne;	~ ()~~~In patient		1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116191	11/10/1998	OK	49.0	49		F	11/03/1998	h/a, temp 99.5, stuffy nose, severe muscle aches & pains all over body, broke out in hives, face/lt thigh ;									Y	10/27/1998	10/28/1998	1	NONE	OTH	PUB	Ibuprofen	NONE	clariten/seasonal allergies,tetracycline	~ ()~~~In patient		1						1	Headache; Myalgia; Pyrexia; Rhinitis; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116192	11/10/1998	PA	50.0	50		M	11/02/1998	hives on chin then reacting like pimple, sore & oozing x 1wk;									N	10/26/1998	10/28/1998	2	NONE	OTH	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Infection; Skin disorder; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116193	11/10/1998	NY				F	10/31/1998	3 red circle on arm, feels red, swollen, achy;									N				NONE	PUB	PUB				~ ()~~~In patient		1						1	Myalgia; Oedema peripheral; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116195	11/10/1998	NY	30.0	30		M		swelling from rt shoulder to below the elbow;red, hot w/inc pain;could hardly move arm rt hand dominant;applied ice & took APAP;									Y	10/13/1998	10/14/1998	1	NONE	PVT	UNK	Zantac, Norvasc, Zoloft, Ibuprofen	NONE	NONE	? to something in DTAP as a child;sibling exp unk rxn;~ ()~~~In patient		1						1	Hypokinesia; Injection site hypersensitivity; Injection site pain; Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975780~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~7H91839~4~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0116197	11/10/1998	AL	2.0	2	.1	M	11/03/1998	abrupt onset of rash 3 days p/vax;urticaria all over confluent lower extremities;no systemic findings;										10/30/1998	11/02/1998	3	will do RAST for eggs in 2wk;	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~0985920~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116202	11/10/1998	MO	55.0	55		M	11/05/1998	joint pain in lt arm that spread to the rt hip & rt shoulder anxiety, pain & travelled around joints;alleges the above & that is much better now;says rt shoulder had stabbing pain;									Y	10/08/1998	10/08/1998	0	NA	OTH	PVT	NONE	Denies	Denies	NA~ ()~~~In patient		1						1	Anxiety; Arthralgia; Pain	FLU3~CONNAUGHT LABORATORIES~0978710~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~454956~1~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0116203	11/10/1998	MD	55.0	54		F	11/05/1998	aching, lip swelling off & on, erythematous fine macular rash;									Y	10/26/1998	10/27/1998	1	NA	PVT	PUB		NONE		NONE~ ()~~~In patient		1						1	Face oedema; Myalgia; Rash maculo-papular	FLU3~PARKDALE PHARMACEUTICALS~03088P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116204	11/10/1998	MD	50.0	50		F	11/05/1998	prolonged malaise, h/a, low grade temp, diarrhea, for 1wk;										10/22/1998	10/23/1998	1		PVT	PUB	multiple other	NONE	?tetanus allergy?, sulfa	pt exp unk rxn w/tetanus?~ ()~~~In patient		1						1	Diarrhoea; Headache; Malaise; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~03088P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116207	11/10/1998	MN	69.0	69		F	11/07/1998	very sore arm for 2 days;the next day h/a, body aches, chills, & fever 100 the following day all was nl;									Y	10/26/1998	10/26/1998	0		PUB	UNK				~ ()~~~In patient		1						1	Headache; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0116215	11/11/1998	KY				M	11/04/1998	pt recv vax & weakness in legs & dizziness occurred;adm to hosp w/dx of post vax myelitis;					Y					10/15/1998			unk	UNK	UNK	unk		NKA;smoking & alcohol use unk;	~ ()~~~In patient		1						1	Dizziness; Myasthenic syndrome; Myelitis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0116218	11/11/1998	TX	45.0	45		F	10/19/1998	pt recv vax 9OCT98 around noon & w/in 8hr flu sx developed;w/in 24hr devel full flu sx & has been ill for 9 days;				Y					N	10/09/1998	10/09/1998	0		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	TX98159	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0983300~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116220	11/11/1998	LA	34.0	34		F	11/10/1998	swelling of eyes bilat;swelling of lips;itching of roof of mouth;hives on trunk anterior & posterior;extremities;tightness of chest;SOB;				Y					Y	11/02/1998	11/03/1998	1		PVT	PVT	Alesse 28;birth control pills	NONE	NONE	NA~ ()~~~In patient		1						1	Chest pain; Dyspnoea; Face oedema; Mucous membrane disorder; Pruritus; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E20158HF~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0116221	11/11/1998	LA	22.0	22		F	11/10/1998	itching of upper arm w/redness, induration heat;									Y	11/02/1998	11/04/1998	2	NA	PVT	PVT	NONE;BCP	NONE	NONE	NA~ ()~~~In patient		1						1	Pruritus; Skin nodule; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20158HF~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0116222	11/11/1998	LA	35.0	35		F	11/10/1998	swelling @ site-baseball size pain, redness;									Y	10/30/1998	10/30/1998	0		PVT	PVT	Naproxin;BC pills	NONE	entrometrosis	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~MEDEVA PHARMA, LTD.~E20158HF~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0116229	11/11/1998	MD	38.0	38		F	11/11/1998	2hr post vax severe dizziness occurred-BP inc;SOB, h/a;									Y	10/30/1998	10/30/1998	0	BP 165/117	PVT	OTH	NONE	NONE	shellfish allergy	~ ()~~~In patient		1						1	Dizziness; Dyspnoea; Headache; Hypertension	FLUX~UNKNOWN MANUFACTURER~4988207~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116234	11/11/1998	KS	56.0			M		2 days p/vax pt devel erythema, warmth, swelling & induration;general malaise rt deltoid where pneumonia was given;										10/26/1998	10/28/1998	2	NONE	UNK	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Malaise; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1286H~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0116235	11/11/1998	NY	66.0	66		M	10/30/1998	pt had swelling, redness & pain on motion 4hr p/vax;										10/27/1998	10/27/1998	0		UNK	UNK				~ ()~~~In patient		1						1	Oedema; Pain; Vasodilatation; Oedema; Pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~449100~UNK~IM~~PNEUMO (PNU-IMUNE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~PFIZER\WYETH~449100~UNK~IM~~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0115593	11/12/1998	MN	13.0			M	10/26/1998	Pt recv vax on 10/23/98; on 10/24/98 pt exp seizure				Y					Y	10/23/1998	10/24/1998	1	EEG-no seizure activity	OTH	OTH	Ritalin	NONE	ADHD	NONE~ ()~~~In patient		1						3	Acidosis; Convulsion; Hypertonia; Hypotonia; Convulsion; Convulsion	FLU3~PARKDALE PHARMACEUTICALS~02298P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~02298D~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~2|FLUX~UNKNOWN MANUFACTURER~02298D~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Emergency room visit	Influenza
0116244	11/12/1998	FL	50.0	50		M	10/20/1998	upon arising pain was noticeable in rt arm;in the afternoon was a sudden onset of anterior chest heaviness radiating to upper back;also sudden onset of numbness in rt hand which progressed up to elbow;severe weakness -unable to write;				Y	Y	5			N	10/07/1998	10/14/1998	7	CXR-WNL;CSF fluid elevated;EKG WNL, MRI of cervical & thoracic spine negative;cardiac enzymes WNL;coag studies NWL;electrolytes WNL, CSF fluid mononuclear cells elevated;	OTH	PVT	prevacid		NA	NA~ ()~~~In patient		1						1	Asthenia; Back pain; CSF test abnormal; Chest pain; Hypotonia; Myasthenic syndrome; Pain	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0116245	11/12/1998	PA	15.0	15		F	11/11/1998	5hr p/vax pt had T101.5 & c/o perioral numbness;also c/o numbness of hands (up to mid forearm);pt adm overnight & was given ibuprofen & DPH;sx resolved in 12hr;still c/o myalgias but no paresthesia;had local swelling & warmth;					Y				Y	11/09/1998	11/09/1998	0	NONE	PVT	PUB	Proventil;Vancenase;Claritin;Flonase;Accolate	NONE	asthma	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Myalgia; Paraesthesia oral; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0978490~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0791H~2~IM~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TD~CONNAUGHT LABORATORIES~0934600~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0116250	11/12/1998	CO	39.0	39		F	10/29/1998	pt recv vax & was pregnant;pt exp severe abd  pain & was hosp w/dx of kidney failure;				Y	Y				U	10/22/1998	10/27/1998	5		PUB	PUB	Prozac, stool softener	unk	pregnancy in twenty-fifth week	~ ()~~~In patient	898303002A	1						1	Abdominal pain; Abnormal labour	FLU3~PFIZER\WYETH~4988216~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0116251	11/12/1998	CO	46.0	46		M	10/29/1998	pt recv vax & devel severe abd pain;pt hosp & dx w/kidney failure;				Y	Y				Y	10/21/1998	10/24/1998	3		PUB	PUB	Advil prn	None	Prostate cancer treated with prostectomy	~ ()~~~In patient	898303003A	1						1	Abdominal pain; Dysuria; Migraine; Pollakiuria	FLU3~PFIZER\WYETH~4988216~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0116252	11/12/1998	CO	57.0	57		M	10/29/1998	pt recv vax & devel severe abd pain;pt hosp & dx w/kidney failure;				Y	Y				Y	10/21/1998	10/27/1998	6		PUB	PUB	unspecified oral hypoglycemic agent	none	type II DM	~ ()~~~In patient	898303005A	1						1	Abdominal pain; Chest pain; Electrocardiogram abnormal	FLU3~PFIZER\WYETH~4988216~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0116258	11/12/1998	MA	44.0	44		F	10/16/1998	Pt recv vax on10/14/98; on 10/16/98 pt exp sore arm w/ bubbling & red line, fever; tx=Keflex & warm compresses				Y					Y	10/14/1998	10/16/1998	2	UNK	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MA9816	1						1	Injection site hypersensitivity; Injection site pain; Lymphadenopathy; Pyrexia; Skin striae	FLU3~CONNAUGHT LABORATORIES~0978490~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0870H~5~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0116259	11/12/1998	OK	57.0	57		F	10/27/1998	Pt recv vax on 10/23/98; on same day pt exp sweating, shortness of breath & heart palpitations, unable to swallow; petechia on feet tx=Benadryl				Y					Y	10/23/1998	10/23/1998	0	EKG-Normal, CBC-Normal, glucose up	PUB	PVT	Endocin	NONE	Arthritis, Thyroid	NONE~ ()~~~In patient	OK9841	1						1	Dysphagia; Dyspnoea; Hyperhidrosis; Palpitations; Petechiae	FLU3~PFIZER\WYETH~4988204~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0116260	11/12/1998	CA	48.0	47		F	11/04/1998	Pt recv vax on 10/28/98; on same day pt exp urticaria w/ itching & pain				Y					U	10/28/1998	10/28/1998	0	UNK	OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Pain; Pruritus; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~0981790~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116261	11/12/1998	OH	33.0	33		F	10/28/1998	Pt recv vax on 10/27/98; on same day pt exp hot, red & swelling w/ pain				Y					N	10/27/1998			UNK	PUB	OTH	Aynacort, Ventolin, Serevent	UNK	Asthma	NONE~ ()~~~In patient	OH98084	1						1	Oedema; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0966960~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454979~1~SC~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0116263	11/12/1998	MA	57.0	57		M	10/27/1998	Pt recv vax on 10/23/98; on same day pt exp malaise, sore LA, decreased movement LA, redness & swelling LA w/ itching; tx=Benadryl & antibiotics				Y					Y	10/23/1998	10/23/1998	0	NONE	PUB	OTH	Motrin 800mg daily	NONE	Many allergies/immuno therapy x 10yr;off allergy shot '95	NONE~ ()~~~In patient	MA9818	1						1	Hypersensitivity; Hypokinesia; Malaise; Oedema; Oedema peripheral; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975790~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0870H~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0116265	11/12/1998	TX	50.0	50		F	11/12/1998	Pt recv vax on 10/30/98; pt was injected w/ empty needle, then recv vax.  Post vax pt exp swelling & pain at vax site; tx=Trovan				Y					U	10/30/1998	10/30/1998	0	NONE	PUB	PUB	UNK	UNK	Allergic to PCN	UNK~ ()~~~In patient	SA98010	1						1	Injection site oedema; Oedema; Pain	FLU3~CONNAUGHT LABORATORIES~0984540~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~7K91938~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0116266	11/12/1998	IL	19.0	19		M	11/06/1998	Pt recv vax on 10/31/98; on 11/1/98 pt exp red rash on arms, legs & back w/itching; tx=Benadryl									U	10/31/1998	11/01/1998	1	UNK	PUB	OTH	UNK	NONE	UNK	UNK~ ()~~~In patient		1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~0983290~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116267	11/12/1998	IL	71.0	71		F	11/06/1998	Pt recv vax on 10/31/98; on same day pt exp hives over body w/itching x 4dy; tx=Caladryl lotion, Benadryl, Benadryl cream									Y	10/31/1998	10/31/1998	0	UNK	PUB	OTH	UNK	NONE	UNK	UNK~ ()~~~In patient		1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~0984540~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116268	11/12/1998	IL	54.0	54		F	11/06/1998	Pt recv vax on 10/24/98; on 10/27/98 pt exp itchy rash over body; tx=Benadryl									U	10/24/1998	10/27/1998	3	UNK	PUB	OTH	UNK	NONE	UNK	UNK~ ()~~~In patient		1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~0983290~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116269	11/12/1998	IL	50.0	50		F	11/06/1998	Pt recv vax on 10/30/98; on same day pt exp red rash over legs w/itching; tx=hydrocortisone cream									U	10/30/1998	10/30/1998	0	UNK	PUB	OTH	UNK	NONE	UNK	UNK~ ()~~~In patient		1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~0983290~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116270	11/12/1998	VA	66.0	66		M	10/23/1998	Pt recv vax on 10/21/98; on 10/22/98 pt exp erythema & pitting edema on arm; pain at vax site; tx=ice, anti-inflammatory, elevate arm									U	10/21/1998	10/22/1998	1	UNK	PUB	PUB	Zestril	NONE	NONE	UNK~ ()~~~In patient	VA98077	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4988212~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~454957~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0116271	11/12/1998	OH	38.0	38		M	10/27/1998	Pt recv vax on 10/26/98; on same day pt exp chills, excess urine, nausea, leg aches									Y	10/26/1998	10/26/1998	0	NONE	OTH	PVT	NONE	NONE	Rheumatic fever as a child	NONE~ ()~~~In patient	OH98083	1						1	Chills; Nausea; Pollakiuria	FLU3~CONNAUGHT LABORATORIES~0985920~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116272	11/12/1998	MA	75.0	75		F	11/09/1998	Pt recv vax on 10/19/98; on 10/20/98 pt exp itchy palms of hands, fingers, toes & scalp, hives under LA & torso area; tx=Hydroxyzine									Y	10/19/1998	10/20/1998	1	UNK	PUB	OTH	Claritin, Hydroxyzine	NONE	Environmental allergies, NKDA, asthma	NONE~ ()~~~In patient	MA9819	1						1	Lymphadenopathy; Pruritus; Urticaria; Lymphadenopathy; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~0975780~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0975780~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0116273	11/12/1998	SC	67.0	67		F	11/04/1998	Pt recv vax on 11/1/98; post vax pt exp stinging at vax site, redness, swelling, hot at site also; tx=hot compress x2 day									Y	11/01/1998	11/01/1998	0	NONE	PUB	PUB	Premarin, Toporol, Allegra	NONE	Chronic sinus	UNK~ ()~~~In patient	SC98066	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0984530~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~0963390~1~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0116274	11/12/1998	ID	59.0	59		F	11/09/1998	Pt recv vax on 10/30/98; on same day pt exp cough,nausea, leg cramp, chills, fever, aches, night sweats, weakness, sore stomach, tired x2 day									Y	10/30/1998	10/30/1998	0	UNK	OTH	PUB	Estrogen replacement, Vitamin B	NONE		UNK~ ()~~~In patient		1						1	Asthenia; Bronchitis; Dyspepsia; Hyperhidrosis; Hypertonia; Myalgia; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0985920~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116275	11/12/1998	NJ	47.0	47		F	11/06/1998	Pt recv vax on 11/3/98; on same day pt exp headache, diarrhea x36 hr, red, raised, hot vax site area.									Y	11/03/1998	11/03/1998	0	NONE	OTH	PUB	Allegra, Multi-vitamins	NONE	Migraines, seasonal allergies	UNK~ ()~~~In patient		1						1	Diarrhoea; Headache; Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0977210~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116276	11/12/1998	OK	50.0	50		F	10/30/1998	Pt recv vax on 10/29/98; post vax pt exp headache, dizziness, dry mouth, eye pain, breaking out around neck									Y	10/29/1998	10/29/1998	0	NONE	PUB	PUB	NONE	NONE	Reconstruction of right breast -10/21/98	NONE~ ()~~~In patient	OK9839	1						1	Dizziness; Eye pain; Headache; Rash	FLUX~UNKNOWN MANUFACTURER~4988249~7+~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116277	11/12/1998	IN	38.0	38		F	10/29/1998	Pt recv vax on 10/20/98; post vax pt exp red, swollen, warm, painful vax site area 3-4 in diameter									Y	10/20/1998			UNK	OTH	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4988205~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116278	11/12/1998	IN	28.0	28		F	10/29/1998	Pt recv vax on 10/14/98; on same day pt exp red, swollen, warm, painful vax site (3-4 in diameter)									Y	10/14/1998	10/14/1998	0	UNK	OTH	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4988205~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116279	11/12/1998	IN				F	10/29/1998	Pt recv vax on 10/14/98; on same day pt exp red, swollen, warm, pain vax site									Y	10/14/1998	10/14/1998	0	UNK	PVT	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4988205~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116280	11/12/1998	IN	59.0	58		F	10/29/1998	Pt recv vax on 10/14/98; on same day pt exp red, swollen, warm, painful vax site									Y	10/14/1998	10/14/1998	0	UNK	PVT	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4988205~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116281	11/12/1998	IN	43.0	43		F	10/29/1998	Pt recv vax on 10/14/98; on same day pt exp red, swelling, warmth, & pain at vax site									Y	10/14/1998	10/14/1998	0	UNK	PVT	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4988205~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116284	11/12/1998	MA	44.0	44		F	11/04/1998	Pt recv vax on 11/2/98; on same day pt exp LA swelling, red, warm & hard spread to lower left neck.									Y	11/02/1998	11/02/1998	0	UNK	PUB	PUB	Humibid, Duratess		Seasonal pollen allergies, 1 mo prior:bronchial pneumonia	NONE~ ()~~~In patient	MA9817	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Lymphadenopathy; Oedema; Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~0978490~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0870H~1~SC~LA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~0960580~4~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0116286	11/12/1998	WI	27.0	26		F	11/05/1998	Pt recv vax on 11/4/98; on same day pt exp hot, flush vax site w/ red blotchy neck, upper chest & upper LA, redness of ears, cough (90 min); tx=Benadryl									Y	11/04/1998	11/04/1998	0	NONE	OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Cough; Injection site hypersensitivity; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0983330~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116287	11/12/1998	SD	50.0	50		F	11/06/1998	Pt recv vax on 10/23/98; on same day pt exp pain & numbness of  vax site, pain in left hip &leg, dizzy, left side pain & numbness, headache, neck & shoulder pain, diarrhea, tired x 10dy									Y	10/23/1998	10/23/1998	0	UNK	PUB	OTH	UNK	UNK	Fibromyalgia, Allergies to Penicillin, Sulfa &yellow dye	UNK~ ()~~~In patient		1						1	Asthenia; Diarrhoea; Dizziness; Headache; Myalgia; Neck pain; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0968380~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116288	11/12/1998	GA	8.0	8		F	11/11/1998	Pt recv vax on 11/9/98; on 11/10/98 pt exp red, swollen, warm vax site									Y	11/09/1998	11/10/1998	1	UNK	PVT	PVT	NONE	NONE	VSD closure	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~022988~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116289	11/12/1998	MT	44.0	44		F	11/05/1998	Pt recv vax on 10/8/98; on 10/9/98 pt exp pain at vax site w/ decreased movement, funny feeling, stiff neck, difficulty sleeping									U	10/08/1998	10/09/1998	1	UNK	PUB	PUB	UNK	NONE	NONE	NONE~ ()~~~In patient	MT98027	1						1	Hypertonia; Malaise; Myalgia; Nuchal rigidity	FLU3~PFIZER\WYETH~4988210~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116292	11/12/1998	ID	26.0	26		F	11/04/1998	Pt recv vax on 10/27/98; on same day pt exp vomiting, swollen eyes & myalgia; tx=rest									Y	10/27/1998	10/27/1998	0	NONE	PVT	PVT	NONE	NONE	Childhood allergies, asthma, childhood anaphylaxis to unknown substance	~ ()~~~In patient		1						1	Face oedema; Myalgia; Vomiting	FLU3~CONNAUGHT LABORATORIES~0977170~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116293	11/12/1998	FL	79.0	79		M	11/07/1998	Pt recv vax on 10/29/98; post vax pt exp headache & aches all over x 12-16 hr; tx=aspirin									N	10/29/1998			UNK	PUB	OTH	HCTZ, Potassium, Metoprolol	UNK	UNK	UNK~ ()~~~In patient		1						1	Headache; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116296	11/12/1998	SC	64.0	64		F	10/30/1998	Pt recv vax on 10/27/98; on 10/28/98 pt exp red spot & pain w/ warmth & swelling on LA(6x4 in), nausea, fever									Y	10/27/1998	10/28/1998	1	UNK	PUB	PUB	NONE	NONE	NONE	UNK~ ()~~~In patient	SC98065	1						1	Injection site hypersensitivity; Injection site oedema; Nausea; Pain; Pyrexia; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0984530~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1094H~1~SC~LA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~0963390~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0116272	11/13/1998	MA	75.0	75		F	11/09/1998	pt recv vax 19OCT98 the day p/palms of hands, fingers, toes & scalp were terrible itchy;pt dermatologist recommended;hydroxyzine;pt reported hives under lt arm area;									Y	10/19/1998	10/20/1998	1		PUB	OTH	Claritin;Hydroxyzine	NONE	environmental allergies, NKDA, asthma	NONE~ ()~~~In patient		1						2	Lymphadenopathy; Pruritus; Urticaria; Lymphadenopathy; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~0975780~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0975780~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0116348	11/13/1998	VA	67.0	67		F	11/06/1998	pt recv vax 19OCt98 & 20OCT98 exp blurred vision,next day exp diarrhea & weakness;then exp n/v, weakness, vomiting, nausea, needed help to walk;hosp until Tuesday for rhabdomyolysis r/t flu vax;pt stated enzyme attacked muscles in body;					Y	4			U	10/19/1998	10/20/1998	1	unk	PVT	PVT	Baycol, Lopid & more	NONE	HTN & cholesterol	~ ()~~~In patient		1						1	Amblyopia; Asthenia; Diarrhoea; Enzyme abnormality; Hypokinesia; Myopathy; Vomiting; Asthenia; Diarrhoea; Hypercholesterolaemia; Hyperglycaemia; Hypokinesia; Myopathy; Tremor; Visual disturbance	FLU3~MEDEVA PHARMA, LTD.~E20188HC~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~E20188HC~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Hospitalisation	Influenza
0116349	11/13/1998	NY	79.0	79		F	11/05/1998	while visiting neighbor across street pt collapsed w/o reason, & was taken by amb to hosp;					Y	12			Y	10/09/1998	10/11/1998	2		UNK	PUB	ASA	NONE	NONE	NONE~ ()~~~In patient		1						1	Shock	FLUX~UNKNOWN MANUFACTURER~E20178HA~2~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0116350	11/13/1998	PA	17.0	17		F	11/10/1998	@ 7PM recv vax & MN took 1st dos of vax & 15min later devel dizziness & tremors (lt sided);had taken lodine & advil in past;adm to hosp & later dx w/serum sickness;				Y	Y	4			Y	11/04/1998	11/05/1998	1		PVT	UNK	Hydrocortisone inj;Advil;lodine XL	shoulder injury	NKA	~ ()~~~In patient		1						1	Dizziness; Serum sickness; Tremor	FLU3~CONNAUGHT LABORATORIES~0983290~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0116352	11/13/1998	WI	54.0	54		F	11/06/1998	1PM sx started itchy watery eyes, SOB, trouble swallowing, itchy mouth, back spasms (explosive), diarrhea;adm to hosp;cough, SOB, itchy eyes, throat closing & diff swallowing;hard to stay cognizant;cramping;nausea;					Y				Y	11/05/1998	11/05/1998	0	EKG-heart monitor, blood work, CXR	PUB	PVT	Ventolin inhaler PRN;HCTC;Estrogen & progestin;		chronic bronchitis;allergic to cats, mildew, PCN, mold, dust lactose intolerance;allerty to red welches grap juice;latex allergy;hx of colitis;	pt exp rxn 16 or 17 w/flu dose 1;~ ()~~~In patient	FLU90021198	1						1	Anaphylactoid reaction; Conjunctivitis; Diarrhoea; Dysphagia; Dyspnoea; Lacrimal disorder; Muscle spasms; Thinking abnormal	FLU3~PARKDALE PHARMACEUTICALS~00508P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0116354	11/13/1998	SC	2.0	2	.8	M	11/10/1998	tonic clonic sz activity last 1hr;no fever or other problems;no cyanosis, cardiovascular compromise 8NOV98 4-5PM;				Y					Y	11/02/1998	11/08/1998	6	nl electrolytes;EEG pending;	PVT	OTH	NONE	NONE	26wk premature infant, BPD, developmental delay	~ ()~~~In patient		1						1	Convulsion	DTPHIB~PFIZER\WYETH~453471~4~~LL~DTP + HIB (TETRAMUNE)~1|FLU3~CONNAUGHT LABORATORIES~0984530~3~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1175H~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|OPV~PFIZER\WYETH~456913~4~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~1	USA	Emergency room visit	Influenza
0116358	11/13/1998	NJ	50.0	50		M	11/02/1998	pt recv vax & 1/2hr devel swelling, erythema & discomfort @ site;condition progressed from shoulder to elbow;pt also had faint tingling & numbness in lips;				Y					Y	10/30/1998	10/30/1998	0	no labs done	PUB	PUB	Deconsol II	NONE	HTN allergic to brewers yeast, olives, watermellon	pt exp aches, congestion @ 20, 22 w/flu vax;~ ()~~~In patient	NJ9829	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Pain; Paraesthesia; Paraesthesia oral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0981840~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116360	11/13/1998	MN	41.0	40		F	11/09/1998	pt recv vax 4NOV98 awake 6NOV98 w/hives over entire body;took DPH w/some relief;				Y					Y	11/04/1998	11/06/1998	2		PUB	PUB	Zoloft, Zyrtec	NONE	NONE	NONE~ ()~~~In patient	MN98023	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~0983310~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116362	11/13/1998	NY	49.0	49		F		SOB, feeling of constricted throat;given med;				Y					Y	11/02/1998	11/02/1998	0		PVT	PVT	Premarin	NONE		~ ()~~~In patient		1						1	Dyspnoea; Laryngospasm	FLU3~PFIZER\WYETH~4988207~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0116364	11/13/1998	WA	46.0	46		M	11/08/1998	31OCT-present flu sx, sinus, muscle, temp 101-102, swollen upper arm-some general sickness;				Y					U	10/30/1998	10/31/1998	1		OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Influenza; Malaise; Myalgia; Oedema peripheral; Pyrexia; Sinusitis	FLU3~MEDEVA PHARMA, LTD.~E20238KD~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0871H~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0116365	11/13/1998	LA	52.0	51		F	11/09/1998	p/vax 1025AM pt went to car & then returned to pay for vaccine & became SOB & c/o tightness in chest;pt placed on back & requested head stay elevated to help w/breathing;BP 182/98, P140, c/o lightheadedness;02 began;P118, resp 24;				Y					Y	11/09/1998	11/09/1998	0	NONe	PUB	PUB	NONE	NONE	allergies to EES, tetracycline, no  other med conditions	NONE~ ()~~~In patient	LA981105	1						1	Chest pain; Dizziness; Dyspnoea; Hypertension; Hyperventilation; Tachycardia	FLU3~CONNAUGHT LABORATORIES~0980530~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~LEDERLE LABORATORIES~455935~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0116366	11/13/1998	OK	40.0			F	11/06/1998	pt recv vax 1130AM 4NOV98 & 3PM same day red watery, irritated eyes, persistent cough, tightness in throat, wheezing, diff breathing, red/flushed skin appearance, severe h/a;				Y					Y				UA, blood analysis, CXR	OTH	OTH	NONE	chronic allergic rhinitis	cereal/allergies/hayfever	NONE~ ()~~~In patient	FLU90031198	1						1	Anaphylactoid reaction; Conjunctivitis; Cough; Dyspnoea; Headache; Lacrimal disorder; Laryngospasm; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~00408P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0116368	11/13/1998	CO	68.0	68		F	11/10/1998	pt recv vax & drove approx 1.5blocks, became weak, tachycardic, felt faint;spouse headed for ER however w/in approx 5min began feeling better & did not go in ER;inj site began itching & burning immed preceding dyspnea rxn tachycardia;									Y	10/13/1998	10/13/1998	0		OTH	PUB	Diclofenac;Estratest;Pravachol;clonidine;Centrum silver;vitamin E;OsCal;Klaron;PRN APAP Ultram, triazolam, Lorazepam, cyclobenzzaprine;		hyperlipidemia;osteoarthritis;obesity;HTn;rosacea;+TB reactor w/o symptomatology;cyst, lt kidney;ruptured appendix age 6 1936;tonsillectomy 1949;2 breast biopsies, 1, fibroadenoma, 1 fibrocystic disease 44, 58;cholecystectomy 1965;D&C x 2	~ ()~~~In patient		1						1	Asthenia; Dizziness; Injection site hypersensitivity; Pruritus; Tachycardia	FLU3~CONNAUGHT LABORATORIES~0972860~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116369	11/13/1998	WA	81.0	81		F	10/20/1998	pt recv vax 17OCT98 & 18OCT98 c/o a hive like rash;no SOB or diff breathing;given pred for hives;									Y	10/17/1998	10/18/1998	1	NONE	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Urticaria	FLU3~PFIZER\WYETH~4988203~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116371	11/13/1998	MI	73.0	73		F	11/06/1998	swollen brown/black, mostly black, size of orange first day 30OCT98 x 70mm round;6NOV98 size of egg, orange yellow around edges purple center;									Y	10/30/1998	10/30/1998	0	NONE	PUB	PUB	baby ASA	cold  w/cough/no fever	NONE	~ ()~~~In patient	MI98124	1						1	Skin discolouration; Skin nodule	FLU3~PFIZER\WYETH~498820L~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116372	11/13/1998	MI	34.0	34		M	11/06/1998	itchy bumps on back of legs while was sleeping the noc got the vax;bumps cont to spread as of today;									U	11/04/1998	11/04/1998	0	NONE	PUB	PUB	NONE	NONE	PCN allergy-same sx & signs	NONE~ ()~~~In patient	MI98125	1						1	Pruritus; Urticaria	FLU3~PFIZER\WYETH~4988203~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116373	11/13/1998	OR	29.0	29		M	11/02/1998	chills, fever, n/v, h/a x >24hr;onset of chills 6hr post vax;									Y	10/23/1998	10/23/1998	0	NONE	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~0981790~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116374	11/13/1998	IL	71.0	71		M	11/09/1998	1wk p/vax started itching all over body;it lasted about 5 days;day 3 severest;									Y	10/20/1998	10/27/1998	7		PUB	UNK	Glucophage;Atenolol	NONE	type 2 diabetes	~ ()~~~In patient		1						1	Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116377	11/13/1998	AZ	55.0	55		F	11/05/1998	w/in 24hr devel high fever & pain in chest under rt ribs;fever died down as pain in ribs decreased;fever 1001 did not go away until 20OCT98 14days p/vax;									Y	10/06/1998	10/07/1998	1	NONE	OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Chest pain; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~03088P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116378	11/13/1998	CA	66.0	66		M	11/08/1998	blood in urine before & after dinner;later coughing, chronic nose bleed & sore throat;pt still coughing;									U	10/01/1998	11/01/1998	31	UA was done the next day p/surrounded;it showed hemo nl;	OTH	PUB	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Cough; Epistaxis; Haematuria; Pharyngitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116379	11/13/1998	MA	62.0	62		M	11/03/1998	started 28OCT98 rash covering torso-neck to knee, bright red raised red areas 1/8, itching still cont w/rash but dec severity;									Y	10/20/1998	10/28/1998	8	NONE	PUB	UNK	vit B12, Prilosec, librex, vit c, glucosamine sulfate	NONE	spastic colon;GERD	~ ()~~~In patient		1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~0975780~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116387	11/16/1998	TX				F	11/09/1998	cellulitis of rt upper arm 24hr p/vax;				Y										UNK	UNK				~ ()~~~In patient		1						1	Cellulitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0116390	11/16/1998	NC	79.0	79		F		Pt recv vax on 10/11/98; on same day pt exp red, warm, swollen LA; tx=ice to site, arm sling, Amoxicillin & Tylenol.  10/15/98 pt imp				Y					Y	10/11/1998	10/11/1998	0	UNK	PUB	PUB	UNK	NONE	UNK	NONE~ ()~~~In patient	NC98048	1						1	Injection site hypersensitivity; Oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975770~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~448516~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0116395	11/16/1998	NC	32.0	32		F	11/11/1998	Pt recv vax on 11/6/98; 2 hr later pt exp cough & shortness of breath				Y					Y	11/06/1998	11/06/1998	0	UNK	PUB	PUB	UNK	UNK	UNK	Pt whole family has rx from flu vax~ ()~~~In patient	NC99008	1						1	Cough; Dyspnoea	FLU3~CONNAUGHT LABORATORIES~0985920~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116396	11/16/1998	FL	59.0	59		F	11/09/1998	Pt recv vax on 10/16/98; on 10/17/98 pt exp vax site pain w/ 2 red welts (2-3 in), hotness; tx=Decadron shot, cortisone cream x2 day; pt imp 2-3 day				Y					Y	10/16/1998	10/17/1998	1	UNK	PVT	PVT	UNK	NONE	UNK	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0967040~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~~1~~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0116398	11/16/1998	AZ	63.0	63		F	11/11/1998	Pt recv vax on 10/15/98; on same day pt exp chills & fever(100.5), achy feeling, hives/itching at night-back, stomach &nape of neck, swollen&numb lips; dx=pneumonia&allergies; tx=cough syrup,Augmentin-Erythromycin,Benadryl;seen by allergist				Y					Y	10/15/1998	10/15/1998	0	10/18/98-Chest X-ray: pneumonia, 11/3/98-Blood test/latex test:  postive	OTH	PUB	NONE	NONE	NONE	UNK~ ()~~~In patient		1						1	Hypersensitivity; Malaise; Myalgia; Paraesthesia oral; Pruritus; Pyrexia; Urticaria	FLU3~CONNAUGHT LABORATORIES~0978690~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116407	11/16/1998	OH	56.0	56		F	11/03/1998	Pt recv vax on 11/2/98; on same day pt exp pain/swollen/red/itchy vax site, increased heart rate & dry mouth; tx=Benadryl, Keflex, Tylenol, ice packs &heat to site				Y					U	11/02/1998	11/02/1998	0	UNK	PUB	PUB	UNK	NONE	UNK	UNK~ ()~~~In patient	OH98088	1						1	Dry mouth; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus; Tachycardia	FLU3~CONNAUGHT LABORATORIES~0977170~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454977~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0116408	11/16/1998	TX	61.0	61		F	11/05/1998	Pt recv vax on 10/28/98;(8-10 hr post vax pt exp sore throat, swollen lip & inside of mouth									Y	10/28/1998	10/28/1998	0	NONE	UNK	UNK	Zestril 20		High blood pressure, LVH	~ ()~~~In patient		1						1	Face oedema; Mucous membrane disorder; Pharyngitis; Tongue oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116409	11/16/1998	IA	49.0			F	11/04/1998	Pt recv vax on 11/3/98; 3 hr later pt exp swollen/red/watery eyes, low back pain, thigh pain, chills; tx=ice for eyes & Tylenol									U	11/03/1998	11/03/1998	0	UNK	OTH	OTH	Claritin	UNK	Feather allergies, seasonal allergies	UNK~ ()~~~In patient		1						1	Back pain; Conjunctivitis; Eye disorder; Eye pain; Face oedema; Lacrimal disorder; Myalgia	FLUX~UNKNOWN MANUFACTURER~00508P~UNK~IM L~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116412	11/16/1998	OH	57.0			F		Pt recv vax on 11/4/98; on 11/5/98 pt exp raised, warm, red &blue hemangioma lesion at vax site (10x6 cm)										11/04/1998	11/05/1998	1	UNK	UNK	UNK	Vitamin C, Vitamin B12, Vitamin E - 11/4/98	UNK	Allergies to sun, grass, Erythromycin, shellfish, nickel, Sorbital	Pt exp red, raised rx at vax site for past 3 yr post Flu vax~ ()~~~In patient		1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Skin discolouration; Vascular anomaly; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~20248KF~4~IM A~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0116413	11/16/1998	OH	63.0	63		M	10/28/1998	Pt recv vax on 10/23/98; on 10/27/98 pt exp sore arm, stomach cramps & pain, vomit, diarrhea x 5 day									Y	10/23/1998	10/27/1998	4	UNK	PUB	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	OH98085	1						1	Abdominal pain; Diarrhoea; Myalgia; Vomiting	FLU3~CONNAUGHT LABORATORIES~0985920~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116414	11/16/1998	OH	37.0	37		F	10/29/1998	Pt recv vax on 10/27/98; on 10/28/98 pt exp headache, joint pain, malaise, fever (100.1), nausea &vomiting									N	10/27/1998	10/28/1998	1	NONE	PUB	PUB	Advil, Synthroid	NONE	Surgical removal of thyroid	UNK~ ()~~~In patient	OH98086	1						1	Arthralgia; Headache; Malaise; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~0978670~UNK~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116421	11/16/1998	MD	74.0	74		F	11/04/1998	Pt recv vax on 11/2/98; on same day pt exp nausea, hot feeling; tx=Pepto Bismol									Y	11/02/1998	11/02/1998	0	NONE	PUB	PUB	3 inhalers for emphysema, high blood pressure med, Tylenol 4-6 daily	NONE	Always feels bad, arthritis, NKMA, emphysema, high blood pressure	UNK~ ()~~~In patient	MD98017	1						1	Dizziness; Nausea; Vasodilatation	FLU3~PFIZER\WYETH~4988203~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~151OE~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0116422	11/16/1998	LA	55.0	55		F	11/02/1998	Pt recv vax on 10/27/98; 1 hr later pt exp rash on face, upper chest, left side of body									Y	10/27/1998	10/27/1998	0	NONE	UNK	UNK	Prilosec, Indapamide	NONE	Asthma, hypertension			1						1	Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~0984540~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116423	11/16/1998	LA	37.0	37		F	10/30/1998	Pt recv vax on 10/23/98; on 10/27/98 pt exp weakness, lightheaded & chills									Y	10/23/1998	10/27/1998	4	UNK	PVT	PVT	NONE	NONE	NONE	UNK~ ()~~~In patient		1						1	Asthenia; Chills; Dizziness	FLU3~CONNAUGHT LABORATORIES~0984540~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116424	11/16/1998	LA	56.0	55		F	10/30/1998	Pt recv vax on 10/26/98; on same day pt exp flu-like sxs x 1wk									Y	10/26/1998	10/26/1998	0	NONE	MIL	PUB	NONE	NONE	NONE	UNK~ ()~~~In patient		1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0984540~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116425	11/16/1998	AR	59.0	59		F	10/20/1998	Pt recv vax on 10/20/98; 20 min later pt exp numbness & tingling of tongue x 15 min; shortness of breath & wheezing; 10/21/98 pt imp									Y	10/20/1998	10/20/1998	0	UNK	PUB	OTH	Lipitor, Synthroid, Clonadine, Estrogen	NONE	High blood pressure, Hypothyroid, Hyper lipidema, Allergic to Codeine & Darvocet, Pancreatitis, Renal below, Shingles-dermatitis, neuropathy lower extremities/toxemia, double ureter	UNK~ ()~~~In patient	AR9868	1						1	Asthma; Dyspnoea; Paraesthesia; Tongue disorder	FLU3~CONNAUGHT LABORATORIES~0983320~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116426	11/16/1998	WA	63.0	63		M	11/13/1998	Pt recv vax on 10/30/98; on same day pt exp edema & erythema of vax site to left hand x several day; tx=elevation of arm, ice, Ibuprofen, Benadryl									Y	10/30/1998	10/30/1998	0	UNK	PVT	PVT	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~0977170~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454979~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0116427	11/16/1998	OH	39.0	39		F		Pt recv vax on 11/4/98; on same day pt exp itchy arms w/ red, raised bumps, itchy back & legs; pt tx for scabies									N	11/04/1998	11/04/1998	0	UNK	OTH	OTH	Histade x 1y	Stuffy nose-sinus	Allergies, Allertic to Sufla	NONE~ ()~~~In patient		1						1	Infection; Pruritus; Rash maculo-papular; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116429	11/16/1998	VA	81.0	81		F	11/10/1998	Pt recv vax on 10/13/98; 1 hr later pt exp sore arm									Y	10/13/1998	10/13/1998	0	NONE	OTH	OTH	UNK	NONE	NONE	UNK~ ()~~~In patient		1						1	Myalgia	FLU3~CONNAUGHT LABORATORIES~0977180~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116430	11/16/1998	NH	52.0	51		F	11/12/1998	Pt recv vax on 11/11/98; 30 min later pt exp bilateral swelling of throat glands, tight chest, hot vax site									Y	11/11/1998	11/11/1998	0	UNK	PVT	PVT	UNK	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Laryngospasm; Lymphadenopathy; Oedema; Skin nodule; Vasodilatation	FLU3~PFIZER\WYETH~4988228~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116431	11/16/1998	ID	52.0	52		F	11/09/1998	Pt recv vax on 10/30/98; 30 min later pt exp 3x5 in red, hot, tender, hard area at vax site; tx=warm, moist packs & Ibuprofen x6 day									Y	10/30/1998	10/30/1998	0	UNK	OTH	OTH	NONE	NONE	Allergic to Penicillin	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116432	11/16/1998	KS	44.0	44		M	11/09/1998	Pt recv vax on 11/5/98; on same day pt exp fever, paleness, chills, numb lips&gums, achy, headache, cough, sore throat, shortness of breath, shaky x 2-3 day									Y	11/05/1998	11/05/1998	0	UNK	OTH	PUB	Zithromax 10/98	NONE	NONE	NONE~ ()~~~In patient		1						1	Cough; Dyspnoea; Myalgia; Pallor; Paraesthesia; Paraesthesia oral; Pyrexia; Tremor	FLU3~PARKDALE PHARMACEUTICALS~00408P~2~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116433	11/16/1998	KS	53.0	52		F	11/12/1998	Pt recv vax on 11/12/98; 45 min later pt exp itching, tight throat, runny nose; tx=Epinephrine IM Rt arm, Benadryl									U	11/12/1998	11/12/1998	0	NONE	OTH	PVT	Sestril	NONE	Hay fever, Sulfur	UNK~ ()~~~In patient		1						1	Laryngospasm; Pruritus; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0978660~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~LEDERLE LABORATORIES~4978233~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0116434	11/16/1998	GA	52.0	52		F	11/09/1998	Pt recv vax on 11/6/98; on same day pt exp fever (102.4); tx=Advil									Y	11/06/1998	11/06/1998	0	NONE	PVT	PVT	UNK	NONE	NONE	UNK~ ()~~~In patient		1						1	Pyrexia	FLU3~CONNAUGHT LABORATORIES~0984530~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116435	11/16/1998	CA	34.0	34		F	11/09/1998	Pt recv vax on 10/26/98; on same day pt exp hot feeling, swollen eyes, cheeks, lips x 3 day									Y	10/26/1998	10/26/1998	0	UNK	PVT	OTH	NONE	UNK	NONE	UNK~ ()~~~In patient		1						1	Face oedema; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116436	11/16/1998	CA	45.0	44		F	11/10/1998	Pt recv vax on 11/9/98; on same day pt exp tachycardia, high blood pressure, tingling hands, stuffy ears, tight throat									Y	11/09/1998	11/09/1998	0	NONE	PUB	OTH	Prempro, Adevan, Sarevent, Flovent	NONE	Asthma, Allergic to fish & shellfish	UNK~ ()~~~In patient		1						1	Ear disorder; Hypertension; Laryngospasm; Paraesthesia; Tachycardia	FLU3~CONNAUGHT LABORATORIES~09833330~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116442	11/16/1998	OH	72.0	72		F	11/13/1998	Pt recv vax on 11/26/97; on 11/26/97 pt exp dizziness & blurred vision, vax site red,itch &swelling; 12/1/97 pt exp fever (102) & shortness of breath; 3/23/98 pt exp Rt arm & thumb numbness & earaches, sleepiness; 5/26/98 pt exp sensitive t									U	11/26/1997	11/26/1997	0	UNK	PVT	OTH	NONE	NONE	High blood pressure; Sulfa, steroids, bee sting, Posicor allergy	UNK~ ()~~~In patient		1						1	Amblyopia; Dizziness; Dyspnoea; Pain; Paraesthesia; Pyrexia; Somnolence; Tooth disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0116462	11/18/1998	OH	26.0	26		F	11/05/1998	pt recv vax 5NOV98  c/o fever of 103 no relief from APAP diarrhea, emesis, achy muscles & joints & SOB;T103.7, large intestine was inflamed, swollen lymph nodes, sore throat;inc WBC only;					Y	2			N	11/04/1998	11/05/1998	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Arthralgia; Diarrhoea; Dyspnoea; Gastrointestinal disorder; Leukocytosis; Lymphadenopathy; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0978670~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0116464	11/18/1998	NJ	19.0	19		M	11/04/1998	c/o strange sensation (numbness, loss of sensation, pain radiating from lt foot to lt torso to rt side of face);seen by neurologist;adm to hosp 28OCT98; dx ADEM;				Y	Y	7			U	10/13/1998	10/14/1998	1	MRI suggest ADEM;swallowing test rt vocal chord periph;CBC, hep panel, lime di, drug sceens, LFT, RPR-all essentially normal;	OTH	OTH	NONE	NONE	denies	~ ()~~~In patient		1						1	Encephalitis; Pain; Paraesthesia; Vocal cord paralysis; Asthenia; Encephalitis; Gait disturbance; Neuropathy; Pain; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E2014HB~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~E20148HB~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Hospitalisation	Influenza
0116464	11/18/1998	NJ	19.0	19		M	11/11/1998	pt recv vax 13OCT98;c/o lt foot pain 14OCT & lt body pain, numbness since 18OCT98 & rt side of face;referred to ER;neuro;hosp 28OCT98 for acute demyelinating encephalomyelitis;still weak & walking w/cane				Y	Y	7			N	10/13/1998	10/14/1998	1	MRI reveals several demylinating plaques in brain & face per MD;	UNK	PVT	unk	NONE	NONE	~ ()~~~In patient		1						2	Encephalitis; Pain; Paraesthesia; Vocal cord paralysis; Asthenia; Encephalitis; Gait disturbance; Neuropathy; Pain; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E2014HB~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~E20148HB~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Hospitalisation	Influenza
0116465	11/18/1998	OH	78.0	78		M	11/12/1998	no immed rxn, no adverse rxn @ site;no elevated pulse, temp;	Y	10/25/1998							N	10/16/1998	10/25/1998	9	NONE	OTH	PUB	Accolate, Aerobid, albuterol, Isonizid, Zoloft, Pyridoxine, Ritalin, Theophyline;	COPD, ASHD, CHF, HTN, resp failure, PRD	NKA;COPD, ASHD, CHF, HTN, resp failure, PRD	~ ()~~~In patient		1						1	Unevaluable event	FLU3~MEDEVA PHARMA, LTD.~E20228KC~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~455382~1~IM~~PNEUMO (PNU-IMUNE)~1	USA	Results in Death	Influenza
0116466	11/18/1998	OH	79.0	79		M	11/12/1998	no immediate rxn, no adverse rxn @ site, no acute distress resident found w/no BP, no pulse initiated CPR;	Y	10/20/1998							N	10/14/1998	10/20/1998	6	NONE	OTH	PUB	Zestril, Norvasc, Lasix, Ritalin, Pepcid, ensure per tube	CVA, CHF, NIDDM, ASHD, HTN, VHD, CAF, PVD, renal insufficiency, COPD	PCN, cephalosporins;CVA, NIDDM, ASHD, HTN, VHD, CAF, PVD, renal insufficiency, COPD	~ ()~~~In patient		1						1	Cardiac arrest; Hypotension	FLU3~MEDEVA PHARMA, LTD.~E20228KC~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~454382~1~IM~~PNEUMO (PNU-IMUNE)~1	USA	Results in Death	Influenza
0116469	11/18/1998	MD	25.0	25		F	10/27/1998	OCtober 16-21 severe diarrhea, nausea, hives, sl fever 100.0;consulted MD, advised to take immodium, DPH, APAP;advised not to take flu shots again;				Y					Y	10/08/1998	10/16/1998	8	NONE	PUB	PUB	Phentermine;Captopril;Zinc chrome;Clarin	NONE	HTN, obesity	~ ()~~~In patient		1						1	Diarrhoea; Nausea; Pyrexia; Urticaria	FLU3~PFIZER\WYETH~498812~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0116470	11/18/1998	IL	68.0	68		F	10/16/1998	approx 2hr p/vax pt c/o severe h/a;family transported to ER reports h/a persisted x2 days;				Y					Y	10/09/1998	10/09/1998	0		PUB	PUB	Flurbiprofen, Trazodone;HCTZ	severe h/a 2hr p/	sulfa	~ ()~~~In patient		1						1	Headache	FLU3~MEDEVA PHARMA, LTD.~E20158HC~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0116473	11/18/1998	MI	43.0	43		F	10/27/1998	swelling of arm, sore & stiffness traveled up to neck & shoulder;T101, nausea;							Y		N	10/21/1998	10/21/1998	0		OTH	PVT	Premarin;Toprol XL	NONE	h	NONE~ ()~~~In patient		1						1	Hypertonia; Myalgia; Nausea; Oedema peripheral; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0116475	11/18/1998	OH	47.0	47		M		pt recv vax 730PM-8PM 9OCT98 approx 2-230AM 10OCT98 woke wife PM w/diff breathing to hosp )@ given approx 3hr of care in ER:				Y					Y	10/09/1998	10/10/1998	1		OTH	PVT		NONE		~ ()~~~In patient		1						1	Dyspnoea; Hypoxia; Insomnia	FLU3~CONNAUGHT LABORATORIES~0981810~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116476	11/18/1998	MN	22.0	22		F	10/26/1998	pt became pale & weak w/in min p/vax;pt did not feel very good, BP 120/90 usually 110/70;felt hot inside;taken to MD stated rxn to flu vax;				Y					Y	10/22/1998	10/22/1998	0		PUB	PUB	NONE	NONE	demerol, vistaril, codeine	pt sick for 3 days p/flu vax 2yr ago;~ ()~~~In patient	MN98021	1						1	Asthenia; Hypertension; Malaise; Pallor; Vasodilatation	FLU3~PFIZER\WYETH~4988224~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0116477	11/18/1998	MN	81.0	81		F	10/27/1998	pt recv vax & 1-1 1/2hr p/vax w/shaking, chills, pale, hands cool, some cyanosis in fingers rt arm inj given rt) VS 99.2, P72,R16, BP 136/60;passed out;				Y					Y	10/27/1998	10/27/1998	0		PUB	PUB	Vitamins;Verapramil;COumadin;Synthroid	NONE		~ ()~~~In patient		1						1	Chills; Cyanosis; Hypertension; Hypoventilation; Pallor; Pyrexia; Tremor	FLU3~PFIZER\WYETH~498824~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0116478	11/18/1998	SC	40.0	40		F	11/06/1998	27OCT98 approx 5PM pt noticed red & sl enlarged area @ inj site on lt upper posterior arm;warm to touch;28OCT98 AM pt stated had chills, fever, malaise, body aches;red area rt upper arm;red & swollen;inc chills & fever & red raised rash;saw				Y					Y	10/26/1998	10/27/1998	1		OTH	PUB	Welbutrin	NONE	NONE	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Malaise; Myalgia; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0983300~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1278E~1~~LA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~0970520~1~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0116480	11/18/1998	CO	42.0	42		F	10/29/1998	pt recv vax 1230PM & arm was sore about 530PM but did not see ( did not look in the mirror until 29OCT98) & saw an area of erythema, warmth @ site of inj;									Y	10/28/1998	10/28/1998	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	CO98052	1						1	Injection site hypersensitivity; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0983330~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116483	11/18/1998	NY	4.0			M	11/10/1998	eyes red pt c/o of feeling itchy, scratching pt says;wheezing;									Y	11/01/1998	11/10/1998	9		PUB	UNK				~ ()~~~In patient		1						1	Asthma; Conjunctivitis; Pruritus	DTAP~SMITHKLINE BEECHAM~A862A2~UNK~IM~LA~DTAP (INFANRIX)~1|FLU3~CONNAUGHT LABORATORIES~0978490~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0792H~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0116488	11/18/1998	CO	50.0	50		F	11/02/1998	severe h/a, fever, muscle & joint aches tx w/bed rest, fluids & APAP;									Y	10/28/1998	10/28/1998	0	NONE	PVT	OTH	unk					1						1	Arthralgia; Asthenia; Headache; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4988210~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116489	11/18/1998	MS	31.0	31		F	11/12/1998	redden area, knot size of egg, & heated;no problem breathing or any other sx;									Y	11/09/1998	11/10/1998	1	NONE	PUB	PUB		NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0990780~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116490	11/18/1998	MI	55.0	55		F	11/05/1998	fine rash beginning on lt arm spreading to rt arm;no SOB or wheezing;no feeling of throat closing up;exp tight throat w/ phlegm, achy, chills, not feeling well x 2wk.									Y	11/05/1998	11/05/1998	0	NONE	OTH	PUB		NONE	hx of multiple allergies	~ ()~~~In patient		1						1	Chills; Laryngospasm; Malaise; Myalgia; Rash; Salivary hypersecretion	FLU3~PARKDALE PHARMACEUTICALS~03088P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116493	11/18/1998	MD	57.0	57		F	11/12/1998	herpes simplex eruptions x 3 on 7NOV98 & appeared on lips/mucus membranes @ corners of mouth 2 upper & lt lower junctions;h/a x 3 days, general joint discomfort, neck & shoulders;									N	10/29/1998	11/07/1998	9	NONE	PUB	PUB	Estrace;Micronise, Progesterone, Levoid, Propananol;OPC3 & vitamins	NONE	hx of migraines	~ ()~~~In patient		1						1	Herpes simplex; Mucous membrane disorder	FLU3~PFIZER\WYETH~4988212~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116494	11/18/1998	CO	49.0	48		F	11/11/1998	2wk muscle aches, nausea, stomach cramping, loose stools, all flu-like sx, severe h/a, congestion in head & lungs;									Y	10/20/1998			NONE	PVT	PVT				~ ()~~~In patient		1						1	Abdominal pain; Diarrhoea; Headache; Influenza; Lung disorder; Myalgia; Nausea; Rhinitis	FLU3~PARKDALE PHARMACEUTICALS~02198P~2~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116498	11/18/1998	AR	56.0	56		M	11/13/1998	dizzy & weak, aches & pain like flu sx & chills;									Y	11/04/1998	11/04/1998	0		OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Chills; Dizziness; Influenza; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116499	11/18/1998	IL	78.0	78		F	11/06/1998	swelling from shoulder to elbow, sore arm, hard to lift over head or up;									Y	10/30/1998	10/30/1998	0		PUB	PUB	Ziac;synthroid	NONE	allergy to ASA, some medications	NONE~ ()~~~In patient	IL98084	1						1	Hypokinesia; Myalgia; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116500	11/18/1998	OH	33.0	33		F	10/28/1998	diaphoretic passed out;lungs clear no wheezing;4:45 resp easy & regular;BP 90/60;									Y	10/28/1998	10/28/1998	0		OTH	PVT	NA	NONE	NONE	NONE~ ()~~~In patient		1						1	Hyperhidrosis; Hypotension; Syncope	FLU3~CONNAUGHT LABORATORIES~0984530~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116501	11/18/1998	OH	48.0	48		F	10/29/1998	pt exp soreness in arm w/in 1hr p/vax; took APAP;swelling in arm 2hr later;5hr p/vax diff concentrating, malaise, felt hot & pt thought face was feeling puffy;went home 6hr p/vax entire arm & extending to mid back feet swollen;									Y	10/16/1998	10/16/1998	0	NA	PUB	PUB	Feldane;cyotec;Lozs;Elavil;Attace;Provara;Cardina;	no acute illness	HTN, arthritis, depression	NONE~ ()~~~In patient	OH98090	1						1	Face oedema; Malaise; Myalgia; Oedema; Oedema peripheral; Thinking abnormal; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~097717C~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116502	11/18/1998	GA	72.0	72		M	10/30/1998	nausea, severe regurgitation, cold sweats, fever, flushed, chills;									U	10/13/1998	10/25/1998	12	NONE	PUB	PUB	coumadin;Prilosec;	NONE		NONE~ ()~~~In patient	GA98103	1						1	Hyperhidrosis; Pyrexia; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E20158HA~7+~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0116503	11/18/1998	OK	51.0	51		F	11/12/1998	pt states awaking between 1-3Am & felt dizzy;states nausea & abd pain;no diarrhea or vomiting; c/o dizziness entire day;									Y	11/10/1998	11/11/1998	1	NOne	OTH	PVT	Glyburide		diabetes	NONE~ ()~~~In patient		1						1	Abdominal pain; Dizziness; Insomnia; Nausea	FLU3~MEDEVA PHARMA, LTD.~E20118GA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0116506	11/18/1998	CA	62.0	62		F	11/09/1998	w/in 24hr of vax pt had a near syncopal episode followed by weakness, myalgias neck & shoulder stiffness & fever to 103;pt had n/v when temp was elevated;				Y						11/04/1998	11/05/1998	1	none @ this time suggested CBC pt declined;	PUB	PUB	Antihypertensive	pt states none HTN	prev hx of fainting spells since youth, HTN	NA~ ()~~~In patient	CA980122	1						1	Asthenia; Dizziness; Hypertonia; Myalgia; Nuchal rigidity; Pyrexia; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E20128GC~1~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0116507	11/18/1998	IL	63.0	63		F	10/28/1998	on the evening of 21OCT pt exp lt arm swelling & difficulty breathing;went to ER MD confirmed swollen glands under lt arm, redness & swelling @ inj site;also lumps @ throat;				Y					Y	10/21/1998	10/21/1998	0		PUB	UNK		NONE	NONE	~ ()~~~In patient	IL98081	1						1	Dyspnoea; Injection site hypersensitivity; Injection site oedema; Lymphadenopathy; Pharyngitis	FLU3~MEDEVA PHARMA, LTD.~E2013GB~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~CONNAUGHT LABORATORIES~0950740~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0116508	11/18/1998	IL	68.0	68		F	10/28/1998	pt reports red, swollen, itchy upper lt arm near inj site;by 2 days later states entire upper lt arm to just below the lt elbow was red, swollen & very itchy;vomiting & h/a;									Y	10/09/1998	10/10/1998	1	NONE	OTH	PUB	Ativan	NONE	wheel chair bound had polio when 17yr old, allergic to codeine & sulfa;	~ ()~~~In patient	IL98079	1						1	Headache; Injection site hypersensitivity; Injection site oedema; Pruritus; Vomiting	FLU3~CONNAUGHT LABORATORIES~0972840~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116510	11/18/1998	WY	11.0	11		M	10/30/1998	pt recv vax & w/in 2min site hard turned red & swollen & painful;no itching, no resp sxs, no other complaints;DPH given;sx dec w/in 40min;									Y	10/30/1998	10/30/1998	0		PUB	PUB		NONE		pt sibling exp T104.5 @ 18mo w/DTP dose 4~ ()~~~In Sibling	WY9823	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4988239~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~MERCK & CO. INC.~1557E~3~IM~RA~HEP B (RECOMBIVAX HB)~1	USA		Influenza
0116511	11/18/1998	CA	60.0	59		F	10/26/1998	pt recv vax 20OCT98 & states that the following morning p/vax starting having achy, back pain which has lasted this is the 5th day;									U	10/20/1998	10/21/1998	1		PUB	PUB		NONE		fluish for a week last year 1997 with flu vax~ ()~~~In patient	CA980120	1						1	Back pain; Myalgia	FLU3~MEDEVA PHARMA, LTD.~E20168HB~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0116515	11/18/1998	SC	62.0	62		F	10/28/1998	ran fever 101 Saturday/Sunday/Monday;noticed knot under lt arm Friday evening 23OCT98; arm tender & sl red 23OCT98;By Saturday morning area inflamed, red, hot to touch & very tender;5 days p/vax 7 long 3-4 wide area;									Y	10/23/1998	10/23/1998	0	NA	PUB	UNK		NONE	NKDA, had pancreatic surgery w/in last year	~ ()~~~In patient	SC98067	1						1	Injection site hypersensitivity; Injection site inflammation; Injection site pain; Lymphadenopathy; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0980580~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1094H~UNK~~LA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~0970520~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0116556	11/18/1998	GA	66.0			M	10/30/1998	pt exp nausea, severe regurgitation, cold sweats, fever, flushed, chills;									U	10/13/1998	10/15/1998	2		PUB	PUB		NONE		NONE~ ()~~~In patient		1						1	Hyperhidrosis; Pyrexia; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E20158HA~7+~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0115597	11/19/1998	TX	2.0	2	.6	M	11/12/1998	extreme high temp-swelling @ inj site, hot to touch, could not put weight on leg;broke out in a rash;asthma like sx, jaundice like appearance;				Y	Y	5			Y	10/22/1998	10/23/1998	1	unk	PVT	PVT	NONE	NONE	reoccurring OM, pneumonia	~ ()~~~In patient		1						2	Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Pyrexia; Asthma; Hypokinesia; Injection site oedema; Jaundice; Pyrexia; Rash	DT~CONNAUGHT LABORATORIES~7C91563~5~IM~LL~DT ADSORBED (NO BRAND NAME)~1|FLU3~PARKDALE PHARMACEUTICALS~02298P~3~IM~RL~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~0906E~1~SC~LL~PNEUMO (PNEUMOVAX)~1|DT~CONNAUGHT LABORATORIES~7C91563~5~IM~LL~DT ADSORBED (NO BRAND NAME)~2|FLU3~PARKDALE PHARMACEUTICALS~02298P~3~IM~RL~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~MERCK & CO. INC.~0906E~1~SC~LL~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0116528	11/19/1998	MA	2.0	2	.8	F	11/16/1998	pt recv vax 4NOV98 & 5NOV98 pt exp erythema, warmth, & tenderness @ the inj site, & fever of 102;inj site rxn wax 8x9cm in diameter & was quite hard;Md visit required;given md;walked w/limp d/t inj site rxn;somewhat disabled;				Y				Y	Y	11/04/1998	11/05/1998	1		OTH	OTH			unk	no relevant data;~ ()~~~In patient	WAES98110829	1						1	Gait disturbance; Hypokinesia; Injection site hypersensitivity; Injection site mass; Injection site pain; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1541E~1~~~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0116536	11/19/1998	OK	63.0	63		F	11/06/1998	Pt recv vax on 11/2/98; 1 hr later pt exp LA swelling, hard knot, red, hot at vax site w/ pain; tx=hot, moist cloth, Zyrtec, Tylenol				Y					Y	11/02/1998	11/02/1998	0	NONE	OTH	PUB	Tiazac, Glucopage, Premarin, Accuphil	NONE	Verapamil	NONE~ ()~~~In patient	OK9842	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4988204~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1510E~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0116537	11/19/1998	NY	72.0	72		F	11/06/1998	Pt recv vax on 11/5/98; on same day pt exp swelling & bruising of Rt arm, hot to touch, fever (100.6); tx=Tylenol #3 & Keflex				Y					U	11/05/1998	11/05/1998	0	CBC ESR-Electrolytes	PUB	OTH	Dilacor-ASA, Phosamax	NONE	UNK	NONE~ ()~~~In patient		1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~20148HE~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1095H~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0116540	11/19/1998	TX	48.0	48		F	11/11/1998	Pt recv vax on 11/2/98; on 11/5/98 pt exp headache, lightheaded, sore throat, hoarse, popping ears, pain & tight chest, nausea, diarrhea, swollen feet, chills &fever, aches & pains				Y					N	11/02/1998	11/05/1998	3	UNK	OTH	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Chest pain; Ear pain; Headache; Myalgia; Nausea; Oedema peripheral; Pharyngitis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0116549	11/19/1998	MO	5.0	5		F	11/17/1998	pt recv vax 10NOV98 pt did very good w/shot;mom called office 11NOV98 stating rt arm to elbow very swollen & very sore;no temp									Y	11/10/1998	11/11/1998	1	NONE	PVT	PVT	NONE	resolving URI	NKDA, birth defects or medical conditions;	~ ()~~~In patient		1						1	Injection site oedema; Injection site pain	DTAP~PFIZER\WYETH~454759~1~IM~RA~DTAP (ACEL-IMUNE)~1|FLU3~MEDEVA PHARMA, LTD.~E2098L8~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|MMR~MERCK & CO. INC.~1180H~2~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1|OPV~PFIZER\WYETH~453224~4~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~1	USA		Influenza
0116552	11/19/1998	GA	58.0	58		F	11/12/1998	arm hurts, bone aches, middle of arm to fingertips to center of back on lt side;T105, vomit, diarrhea x 2 days, severe bone aches;										11/03/1998				UNK	UNK				~ ()~~~In patient		1						1	Back pain; Bone pain; Diarrhoea; Pain; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116554	11/19/1998	MO	32.0	32		F	10/26/1998	reports rash, itching 24OCT98 2 days p/vax;									Y	10/22/1998	10/24/1998	2		PUB	PUB		NONE	NONE	~ ()~~~In patient	MO98071	1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~0981800~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116558	11/19/1998	MO	46.0	46		F	11/05/1998	2NOV98 3PM chills, hot, sweaty, aching all over, h/a upset stomach 8PM diarrhea x 2 9PM, T103, severe chills all noc, aching, h/a;3NOV98 felt better & slept 8-012noon;cont aching;									Y	11/02/1998	11/02/1998	0	NONE	PUB	PUB	premphase	NONE	allergies, hayfever (ragweed): codeine;	pt recv vax flu sx from flu shot 10yr ago or longer;~ ()~~~In patient	MO98074	1						1	Chills; Diarrhoea; Dyspepsia; Headache; Hyperhidrosis; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0983320~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116560	11/19/1998	IL	60.0	60		F	11/16/1998	2 1/2wk p/vax woke up w/bilat joint stiffness throughout body; 3 1/2 wk p/ c/o paresthesia in the lower extremities & buttock;the week of 28OCT had parasthesia of facial cheeks, ears feeling shaky inside & weak up ambulation;									U	10/03/1998	10/21/1998	18	ANA titer has been WNL recently	PUB	OTH	unk		dx w/lupus 27yr ago;	unk~ ()~~~In patient		1						1	Arthralgia; Ear disorder; Myasthenic syndrome; Paraesthesia; Tremor	FLU3~CONNAUGHT LABORATORIES~0977180~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116561	11/19/1998	FL	44.0	43		F	11/13/1998	devel fever lasting 12hr diarrhea lasting 24hr, inj site red, swollen, hot & sore followed by bruising of arm;lasted 1wk;									Y	10/13/1998	10/13/1998	0		PUB	PUB	Hismanal, Sephrax	NONE	asthma	~ ()~~~In patient	FL98066	1						1	Diarrhoea; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20088GB~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1247H~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0116564	11/19/1998	GA	56.0	56		M		T100.8, generalized aching of joints & skin sensitivity;									Y	10/29/1998	10/30/1998	1		OTH	OTH		NONE	IVp Dye & allergic to PCN;	~ ()~~~In patient		1						1	Arthralgia; Hyperaesthesia; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E20118GA~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0116565	11/19/1998	MA	42.0	42		F	11/14/1998	pt recv vax & got sick & the next morning aches, back, neck, eyes, h/a;felt bad for 4 days then got sick 2wk p/shot;unk if r/t vax;had flu like sx, vomiting, diarrhea, aches, h/a, feeling very sick for 1wk;									Y	10/24/1998	10/25/1998	1	NONE	PUB	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Back pain; Diarrhoea; Eye pain; Headache; Influenza; Myalgia; Neck pain; Vomiting; Diarrhoea; Headache; Myalgia; Vomiting	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0975790~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0116566	11/19/1998	CA	57.0	57		F	11/06/1998	pt recv vax 10Am 31OCT98 & 2PM unexplained coughing spell-used daytime vicks;4PM burning eyes-used eye drops;6PM numbness around mouth-muscle spasm-tingling around mouth;eyes still burning;puffiness very tired-went to sleep;									Y	10/31/1998	10/31/1998	0		PVT	UNK	Estrates H/S;Medroxyprogesterone;Disalcid;Lamisil;	NONE	arthritis, foot fungus	~ ()~~~In patient		1						1	Cough; Eye pain; Face oedema; Hypertonia; Paraesthesia oral; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116565	11/20/1998	MA	42.0	42		F	11/09/1998	Pt recv vax on 10/24/98; on 10/25/98 pt exp body aches & pain x 4 day; vomiting, diarrhea, headache									N	10/24/1998	10/25/1998	1	NONE	PUB	OTH	NONE	UNK	NONE	NONE~ ()~~~In patient	MA9836	1						2	Back pain; Diarrhoea; Eye pain; Headache; Influenza; Myalgia; Neck pain; Vomiting; Diarrhoea; Headache; Myalgia; Vomiting	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0975790~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0116576	11/20/1998	MA	51.0	50		F	10/29/1998	Pt recv vax on 10/24/98; 1 hr later pt exp rash over body; tx=Benadryl				Y					Y	10/24/1998	10/24/1998	0	UNK	PUB	PUB	UNK	NONE	UNK	Pt recv cortisone vax; exp numbness~ ()~~~In patient	MA9824	1						1	Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~0975790~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116579	11/20/1998	MA	66.0	66		F	11/03/1998	Pt recv vax on 10/29/98; on same day pt exp fever&chills, tired, nausea, headache, LA swollen; tx=Tylenol				Y					Y	10/29/1998	10/29/1998	0	NONE	PUB	PUB	Esterectic, Estril, Fluven inhalent	NONE	High blood pressure, Asthma, Allergy to Penicillin, Sulfa, ASA	UNK~ ()~~~In patient	MA9828	1						1	Asthenia; Headache; Nausea; Oedema peripheral; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0975780~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0870H~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0116580	11/20/1998	MA	82.0	81		M	11/05/1998	Pt recv vax on 10/19/98; on same day pt exp swollen/red/hot LA at vax site; tx=Cefadroxil				Y					Y	10/19/1998	10/19/1998	0	UNK	PUB	PUB	UNK	NONE	UNK	UNK~ ()~~~In patient	MA9902	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975780~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1541E~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0116583	11/20/1998	MA	41.0	41		F	11/05/1998	Pt recv vax on 10/27/98; on 10/28/98 pt exp numb LA									U	10/27/1998	10/28/1998	1	NONE	OTH	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0975780~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116586	11/20/1998	MI	41.0	41		M	10/16/1998	On 10/6/98 pt exp puffy/blurry/watery eyes, difficulty breathing; tx=Proventil inhaler									Y	10/01/1998	10/16/1998	15	NONE	OTH	PVT	UNK	UNK	Environmental/ dust/ animals allergies	NONE~ ()~~~In patient		1						1	Amblyopia; Dyspnoea; Face oedema; Lacrimal disorder	FLU3~CONNAUGHT LABORATORIES~0981840~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116587	11/20/1998	AZ	65.0	65		F	11/03/1998	Pt recv vax on 10/31/98; on same day pt exp chills & chattering teeth; 11/1/98-pt arm sore, swollen, red, rash ; 11/2/98 pt imp									Y	10/31/1998	10/31/1998	0	NONE	PUB	PUB	Synthroid, Estrace	NONE	NONE	UNK~ ()~~~In patient	AZ9844	1						1	Chills; Oedema peripheral; Pain; Rash; Tremor	FLU3~CONNAUGHT LABORATORIES~0975790~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0870H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0116588	11/20/1998	AZ	84.0	84		F	10/20/1998	Pt recv vax on 10/15/98; on 10/16/98 pt exp upset stomach x 2-3 day									Y	10/15/1998	10/16/1998	1	NONE	OTH	PUB	Hydroclorothiazide, Lotensin, Zoloft	NONE	HTN, CHF, Alzheimer's, Arthritis	NONE~ ()~~~In patient	AZ9841	1						1	Dyspepsia	FLU3~PARKDALE PHARMACEUTICALS~01998P~7+~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116590	11/20/1998	MA	54.0	54		M	10/21/1998	Pt recv vax on 10/20/98; on same day pt exp chills									Y	10/20/1998	10/20/1998	0	NONE	PUB	PUB	UNK	NONE	NONE	UNK~ ()~~~In patient	MA9820	1						1	Chills	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116591	11/20/1998	MA	88.0	88		F	10/29/1998	Pt recv vax on 10/21/98; on 10/25/98 pt exp lightheadedness, woozy, chills, fever, achiness, weakness; 1 wk illness, still weak - washed out									N	10/21/1998	10/25/1998	4	UNK	PUB	PUB	Fluid pill	NONE	High blood pressure, s/p Basal skin cancer	UNK~ ()~~~In patient	MA9821	1						1	Asthenia; Dizziness; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0975790~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116593	11/20/1998	MA	46.0	46		F	10/30/1998	Pt recv vax on 10/21/98; on 10/22/98 pt exp red/swollen/warm/firm/sensitive/increased in size vax site									Y	10/21/1998	10/22/1998	1	UNK	PUB	PUB	UNK	NONE	UNK	UNK~ ()~~~In patient	MA9823	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975790~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116594	11/20/1998	MA	52.0	52		M	10/29/1998	Pt recv vax on 10/21/98; on 10/23/98 pt exp headache, chills & shaking									N	10/21/1998	10/23/1998	2	NONE	PUB	PUB	UNK	NONE	Cancer tx of esophagus & stomach, Barret's syndrome	UNK~ ()~~~In patient	MA9827	1						1	Chills; Headache; Tremor	FLU3~CONNAUGHT LABORATORIES~0975790~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116595	11/20/1998	MA	40.0	40		M	11/03/1998	Pt recv vax on 10/27/98; on same day pt exp red, hot, itchy, sore swollen LA x 2 day w/ headache 3 day									Y	10/27/1998	10/27/1998	0	NONE	PUB	OTH	Proventil	Getting over the flu virus	Asthma	UNK~ ()~~~In patient	MA9829	1						1	Headache; Oedema peripheral; Pain; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975780~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116596	11/20/1998	MA	39.0	39		F	11/03/1998	Pt recv vax on 10/27/98; on 10/28/98 pt exp sore/hard lump of vax site x 1 day									Y	10/27/1998	10/28/1998	1	NONE	PUB	OTH	NONE	Getting over sinus allergy	Hayfever	Pt son exp rash as infant post pertussis vax #1 dose~ ()~~~In patient	MA9830	1						1	Injection site mass; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0975780~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116597	11/20/1998	MA	53.0	53		F	11/03/1998	Pt recv vax on 10/21/98; 1 hr later pt exp itching, red, hard, hot arm x 3 day									Y	10/21/1998	10/21/1998	0	NONE	PUB	OTH	Baby ASA, Lipitor, Poprol	Diarrhea	Hypertension, High cholesterol, Prolapsed heart valve	Pt daughter allergic to eggs/MMR~ ()~~~In patient	MA9831	1						1	Injection site hypersensitivity; Injection site mass; Pruritus	FLU3~CONNAUGHT LABORATORIES~0975780~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116598	11/20/1998	MA	40.0	40		F	11/03/1998	Pt recv vax on 10/27/98; on 10/28/98 pt exp tiredness, hot/swollen/itchy/sore arm x3 day; itched 3rd day									Y	10/27/1998	10/28/1998	1	NONE	OTH	OTH	Tamoxifen	NONE	Breast cancer 5 yr ago	Pt exp swelling rx from vaxs; Pt sister exp swelling post flu vax~ ()~~~In patient	MA9832	1						1	Asthenia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975780~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116599	11/20/1998	MA	49.0	49		F	11/03/1998	Pt recv vax on 10/27/98; on same day pt exp red, itchy arm x 3 day									Y	10/27/1998	10/27/1998	0	NONE	PUB	OTH	NONE	Feeling under the weather for a while	Allergic to Penicillin & Codeine	UNK~ ()~~~In patient	MA9833	1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~0975780~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116600	11/20/1998	MA	46.0	46		F	11/03/1998	Pt recv vax on 10/27/98; on 10/28/98 pt exp swollen, red, hot, achy arm x 2 day									Y	10/27/1998	10/28/1998	1	NONE	PUB	OTH	Prozac, Clonazepam	Getting over a cold	Seasonal hay fever	UNK~ ()~~~In patient	MA9834	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975780~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116601	11/20/1998	MA	23.0	23		F	10/23/1998	Pt recv vax on 10/20/98; on same day pt exp achy feeling									Y	10/20/1998	10/20/1998	0	NONE	PUB	PUB	UNK	UNK	UNK	UNK~ ()~~~In patient	MA9835	1						1	Myalgia	FLU3~CONNAUGHT LABORATORIES~0975790~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116603	11/20/1998	MS	71.0	71		F	10/26/1998	Pt recv vax on 10/22/98; 2 hr later pt exp lethargy, achiness, nausea, vomit, arm swelling & pain, unable to eat, chills; tx=ice on arm									Y	10/22/1998	10/22/1998	0	UNK	OTH	OTH	UNK	NONE	NONE	UNK~ ()~~~In patient	MS98029	1						1	Anorexia; Myalgia; Oedema peripheral; Pain; Somnolence; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E20158HG~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0906E~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0116604	11/20/1998	MS	19.0	19		F	10/29/1998	Pt recv vax on 10/27/98; post vax pt exp fatigue, muscle aches, red & swollen vax site w/ red lines(LA), nausea, headaches x 2 day									Y	10/27/1998	10/27/1998	0	UNK	PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	MS98030	1						1	Asthenia; Headache; Injection site hypersensitivity; Injection site oedema; Myalgia; Nausea; Skin striae	FLU3~MEDEVA PHARMA, LTD.~E20158HG~2~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0906E~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0115407	11/23/1998	WI	49.0	49		F	11/15/1998	low back pain d/p w/in 4-6hr p/vax; progressed to severe back, flank, hip pain w/chills;pt d/p difficulty standing, walking;tx in ER 4th day for severe joint pain;									Y	10/17/1998	10/17/1998	0	abd flat plate, IVP, CBC were done	OTH	OTH	Loestrin	NONE	NONE	NONE~ ()~~~In patient		1						2	Arthralgia; Arthritis; Back pain; Pain; Pyrexia; Arthralgia; Back pain; Chills; Hypokinesia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~MEDEVA PHARMA, LTD.~~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0115544	11/23/1998	WI	26.0	25		F	11/18/1998	12hr p/vax pt became very ill, emesis/diarrhea, dehydration, chest pains;adm to hosp for IV fluids;on clear liquids until 10OCt;feeling better 9OCT;taking antiemetic for nausea;					Y				Y	10/06/1998	10/07/1998	1		PUB	PVT		NONE		~ ()~~~In patient		1						2	Myalgia; Vomiting; Chest pain; Dehydration; Diarrhoea; Malaise; Nausea; Vomiting; Chest pain; Dehydration; Diarrhoea; Malaise; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~0977180~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0977180~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~0977180~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Hospitalisation	Influenza
0115725	11/23/1998	KY	0.5	0	.5	M	10/26/1998	significant swelling @ the inj site;mild redness noted all up & down the sore arm distal to the inj site when seen by MD 24OCT98;pt recv vax 22OCT98;				Y					Y	10/22/1998	10/23/1998	1		PUB	PUB	Triotann;	wakes up every AM w/sniffling & allergy	allergic to pollen, grass, trees, mold, mildew, cats, some allergy to milk;	~ ()~~~In patient	KY980033	1						2	Injection site hypersensitivity; Injection site oedema; Rash; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4988204~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4988204~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0115906	11/23/1998	MT	89.0	89		F	10/09/1998	c/o immed burning down the lt arm;c/o tightness;7PM c/o n/v & syncope;7OCT98 c/o n/v;taken to ER & admitted;				Y	Y	4			Y	10/05/1998	10/05/1998	0	02, blood drawn, CXR	PUB	PUB	Asthmatic inhaler;Zesteric;Johns 2GM thyroid;	NONE	asthma	pt exp rxn @ age 83 w/pneumonia dose 1;~ ()~~~In patient	MT98025	1						2	Cellulitis; Injection site oedema; Pneumonia; Skin discolouration; Syncope; Vomiting; Pain; Syncope; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E20188HD~6~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~442522~2~IM~LA~PNEUMO (PNU-IMUNE)~1|FLU3~MEDEVA PHARMA, LTD.~E20188HD~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~PFIZER\WYETH~442522~2~IM~LA~PNEUMO (PNU-IMUNE)~2	USA	Hospitalisation	Influenza
0115913	11/23/1998	MO	21.0	21		F	11/10/1998	pt expired w/in 24hr of vax;	Y	10/29/1998							N	10/28/1998	10/29/1998	1		OTH	PVT	unk	NONE	allergic to PCN	~ ()~~~In patient	FLU89171098	1						2	Apnoea; Malaise; Myocarditis; Syncope; Vomiting; Unevaluable event	FLU3~PARKDALE PHARMACEUTICALS~021198P~2~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~02198P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Results in Death	Influenza
0116608	11/23/1998	OK	57.0	57		M	11/16/1998	lab on 21OCT98 CBC platelets count zero- 0;pt adm to hosp on 13OCT98;pt recv flu vax 13OCT98;			Y		Y	17			Y	10/13/1998	10/21/1998	8		UNK	UNK				~ ()~~~In patient		1						1	Ecchymosis; Haematuria; Petechiae; Rash; Thrombocytopenia	FLU3~MEDEVA PHARMA, LTD.~E2008BFC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0116612	11/23/1998	RI	11.0	11		F	11/18/1998	abd pain, h/a, low grade fever, pain in both legs;17NOV98 adm to hosp conjunctivitis, both knees & ankles swelling bilat;diff walking;dx myositis & vasculitis;					Y	1			Y	10/28/1998	11/06/1998	9	CPK 27;ESR 39;	PVT	UNK				~ ()~~~In patient		1						1	Abdominal pain; Conjunctivitis; Gait disturbance; Headache; Osteoarthritis; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0116617	11/23/1998	OK	20.0	20		F	11/08/1998	5:15 @ emergency BP high;6:00 given cortisone & sudafed;rt arm swelling & unmovable;throat swelling & tight;eye dilated;			Y	Y					Y	11/18/1998				UNK	UNK		NONE		~ ()~~~In patient		1						1	Hypertension; Hypokinesia; Laryngospasm; Mydriasis; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0116621	11/23/1998	NY	45.0			F	11/04/1998	pt recv vax 13OCT98 & exp arm pain, facial paralysis, paresthesia & unspecified paralysis;23OCT98 seen by neurologist dx GBS & hosp;tx w/plasmapheresis;improved & D/C 10/30/98				Y	Y	7	Y		Y	10/13/1998	10/14/1998	1		OTH	OTH	NONE	none	none	~ ()~~~In patient	898310155A	1						1	Facial palsy; Guillain-Barre syndrome; Pain; Paraesthesia; Paralysis	FLU3~PFIZER\WYETH~4988209~UNK~A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0116626	11/23/1998	PA	14.0	14		M	11/18/1998	pt recv vax 21OCT98 & 22OCT98 pt exp fever & vomiting;23OCT98 pt exp facial & arm swelling & redness;24OCT98 facial swelling & fever had decreased however arm was still red & swollen w/3 inches of erythema & swelling;								Y	Y	10/21/1998	10/22/1998	1		PVT	PVT			ceclor allergy	No relevant data;~ ()~~~In patient	WAES98102115	1						1	Face oedema; Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Pain; Pyrexia; Vasodilatation; Vomiting	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1542E~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0116640	11/23/1998	KY	45.0	45		F	11/02/1998	30OCT98 trouble breathing;pt felt was from asthma;31OCT98 arm swollen w/redness & red streaks down arm;2NOV98 saw PMD d/t same;tx pred, DPH, cephalexin;				Y					Y	10/30/1998	10/30/1998	0	NONE	PUB	PUB		NONE	allergy codeine, tetracycline	~ ()~~~In patient	KY980035	1						1	Dyspnoea; Oedema peripheral; Skin striae; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0981810~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116642	11/23/1998	KY	40.0	40		F	11/18/1998	pt states 2 days p/vax pt neck & chest devel red rash lasting 48hr;also h/a;pt stated noted reddened areas & knot;				Y					Y	11/05/1998	11/07/1998	2		PUB	PUB	Flexeril, Xanax;pain med	NONE	PCN	NONE~ ()~~~In patient	KY980038	1						1	Headache; Rash; Skin nodule; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0971890~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116643	11/23/1998	OH	27.0	27		F	11/19/1998	pt recv vax 27OCT98 & 29OCT98 reported aches across chest & shoulders, head feels cloudy, runny nose, faint feeling;states breathing is an effort & describes it as heavy breathing;taken to ER;T100 x 4 days;				Y					Y	10/27/1998	10/29/1998	2	pt report no blood work done in ER but MD in ER did several muscle tests;	PUB	UNK	Ortho novum for birth control	NONE	NONE	NONE~ ()~~~In patient		1						1	Dizziness; Dyspnoea; Myalgia; Pyrexia; Rhinitis; Syncope	FLU3~CONNAUGHT LABORATORIES~0975840~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116645	11/23/1998	NY	67.0	67		F		started w/redness to rt arm 13NOV98;seen in clinic 17NOV for cellulitis to rt elbow;				Y					U	11/13/1998	11/13/1998	0		PUB	UNK			diabetes, hypothyroidism, cardiac, allergic to PCN, sulfa	~ ()~~~In patient		1						1	Cellulitis; Injection site hypersensitivity	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~10958~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0116652	11/23/1998	RI	44.0	44		M	11/03/1998	c/o of feeling faint;extreme diaphoresis;mild dyspnea;chest pressure;tightness in throat;BP 98/60, pulse 48-60;				Y					Y	11/02/1998	11/02/1998	0	NONE	PUB	PVT	Actifed;Atrovent;Polyocort;Ibuprofen;	NONE	EES, Doxycycline	NONE~ ()~~~In patient		1						1	Bradycardia; Chest pain; Dizziness; Dyspnoea; Hyperhidrosis; Hypotension; Laryngospasm	FLU3~CONNAUGHT LABORATORIES~0968410~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116653	11/23/1998	NV	67.0	67		F	11/20/1998	pt recv vax 19OCT98 & 20OCT98 c/o lt arm pain @ inj site;sl erythema, sl swelling;pt told to apply cool compress & mild rxn are common & may persist for <48hr;21OCT98 marked local swelling, pain in lt arm spreading to armpit w/erythema, hot				Y					Y	10/19/1998	10/20/1998	1	NONE	PUB	PVT	Ticlid;Zesteril;Quinine sulfate;	NONE	allergy PCN, medical condition HTN, CVA 1993 & 1997	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Lymphadenopathy; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20118GH~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~454384~UNK~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0116654	11/23/1998	NM	37.0	37		F	11/11/1998	anaphylaxis w/gen pruritus, hoarseness, wheezing & possible hypotension 20-30min p/vax;tx w/inhaled racemic epi & DPH & kept on oral allegra bid for 3 days;				Y					Y	10/21/1998	10/21/1998	0	skin testing done 12NOV98 induced a rxn to thimerosal as the suspected reagent as pt showed an adverse response to thimerosal preserved tetanus toxoid fluid (could not find any other thimerosal for skin testing)	PVT	PVT	Ibuprofen	NONE	NONE	~ ()~~~In patient		1						1	Anaphylactoid reaction; Asthma; Dysphonia; Hypersensitivity; Hypotension; Pruritus	FLU3~PFIZER\WYETH~1965010110~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0116657	11/23/1998	SC	61.0	61		F	11/19/1998	Pt recv vax on 11/5/98; 20 min post vax pt exp dizziness & elevated blood pressure				Y					Y	11/05/1998	11/05/1998	0	Blood pressure-170/100	PUB	PUB	Carura, Synthroid, Loumadin	UNK	Silent MI, Thyroid problems, Bradycarida, Mitral valve disease, Esophageal lesion	UNK~ ()~~~In patient	NC99009	1						1	Dizziness; Hypertension	FLU3~CONNAUGHT LABORATORIES~0985920~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116658	11/23/1998	OH	53.0	53		F	11/16/1998	Pt recv vax on 10/22/98; on 10/29/98 pt exp pneumonia; tx=antibiotics				Y					N	10/22/1998	10/29/1998	7	X-rays of lung-pneumonia in right lung	OTH	PUB	NONE	NONE	Heart disease	NONE~ ()~~~In patient		1						1	Pneumonia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0116660	11/23/1998	KY	43.0	43		M	11/17/1998	Pt recv vax on 10/21/98; on 10/22/98 pt exp hives on torso, head & neck; tx=cortisone shot & prescription				Y					Y	10/21/1998	10/22/1998	1	NONE	OTH	PVT	UNK	NONE	Allergic to Penicillin	UNK~ ()~~~In patient		1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0116662	11/23/1998	FL	65.0	65		F	11/11/1998	Pt recv vax on 10/13/98; 2.5 hr post vax pt exp confusion & disoriented; pt imp 24 hr				Y					Y	10/13/1998	10/13/1998	0	CT of head-neg; Doppler-neg	PVT	PVT	Premarin, Naprosyn	NONE	DJD	UNK~ ()~~~In patient		1						1	Anxiety; Confusional state; Amnesia; Cerebrovascular accident; Depersonalisation; Hypertension; Nervousness; Thinking abnormal	FLU3~PARKDALE PHARMACEUTICALS~03088P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~455937~UNK~~LA~PNEUMO (PNU-IMUNE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0116664	11/23/1998	MI	37.0	37		M	11/13/1998	Pt recv vax on 11/5/98; post vax pt exp erythema (circular)  of LA & left axial lymphadenopathy				Y					Y	11/05/1998			NONE	PVT	PVT	Ventolin, Biaxin, Claritin, Zantac, Serevent, Beclovent, Vancenase	Cellulitis of right hand 2FB	Allergic to Penicillin & Cefzil	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Lymphadenopathy	FLU3~CONNAUGHT LABORATORIES~0972110~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0871H~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0116666	11/23/1998	NY	68.0	68		F	11/12/1998	Pt recv vax on 11/2/98; on 11/4/98 pt exp right neck discomfort; 11/7 right facial weakness; dx=Bell's Palsy				Y					N	11/02/1998	11/04/1998	2	UNK	PVT	PVT	Prinivil, Pamelor Betoptic gts	NONE	Hypertension, Glaucoma, History of depression	UNK~ ()~~~In patient		1						1	Facial palsy; Myasthenic syndrome; Neck pain	FLU3~CONNAUGHT LABORATORIES~0981810~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116673	11/23/1998	MI	67.0			M	11/05/1998	Pt recv vax on 10/26/98; on 11/1/98 pt exp swollen, warm, red LA; tx=Keflex				Y					Y	10/26/1998	11/01/1998	6	UNK	PUB	PUB	Allegra, Dyazide, Lopressor, Zyloprim, Cardura, Prevacid	NONE	Hayfever	UNK~ ()~~~In patient	MI98128	1						1	Injection site hypersensitivity; Injection site oedema; Myalgia; Vasodilatation	FLU3~PFIZER\WYETH~4988204~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~7K91938~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0116674	11/23/1998	MI	45.0	45		F	11/02/1998	Pt recv vax on 10/30/98; 4 hr later pt exp swelling/red/ pain/ hot LA; tx=Benadryl gel				Y					U	10/30/1998	10/30/1998	0	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MI98130	1						1	Oedema peripheral; Pain; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20238KM~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~451796~1~SC~LA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~9T1220~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0116677	11/23/1998	TX	62.0	61		F	11/13/1998	Pt recv vax on 11/5/98; on 11/7/98 pt exp red, swollen area at vax site;tx=Erythromycin, Medrol, cortisone				Y					Y	11/05/1998	11/07/1998	2	NONE	PVT	PVT	Cardizem, Prempro, Lozol	NONE	Hypertension			1						1	Infection; Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4988235~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0906E~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0116683	11/23/1998	KY	70.0	69		F		Pt recv vax on 10/20/98; on 10/23/98 pt exp burning/soreness at vax site x 3 day									Y	10/20/1998	10/23/1998	3	NONE	PUB	PUB	Thyrotel, Homove pill, Moxidi	NONE	Allergic to Kefzol-rash&itching, Headaches	NONE~ ()~~~In patient	KY980040	1						1	Condition aggravated; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0971890~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116688	11/23/1998	PA				F	11/10/1998	Pt recv vax on 11/3/98; 4 hr later pt exp fever (100F), achy joints, red/swollen arm, rash										11/03/1998	11/03/1998	0	UNK	OTH	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Arthralgia; Injection site hypersensitivity; Oedema peripheral; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~10984580~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116689	11/23/1998	VA	30.0	30		U	11/03/1998	Pt recv vax on 10/28/98; on same day pt exp firm/swollen/ hot/ painful LA; tx=Zyrtec										10/28/1998	10/28/1998	0	UNK	OTH	OTH	UNK	UNK	NONE	UNK~ ()~~~In patient		1						1	Injection site mass; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0978670~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116692	11/23/1998	IL	65.0	65		F	11/18/1998	Pt recv vax on 11/4/98; 3 hr post vax pt exp sore Rt arm to back, neck, chest x 2 day; whooziness, trouble sleeping, nausea, lightheadedness, shortness of breath										11/04/1998	11/04/1998	0	NONE	PUB	OTH	Zestril, Flovent inhaler, Premarin, Moduretic	NONE	Fibromyalgia & asthma	UNK~ ()~~~In patient		1						1	Back pain; Dizziness; Dyspnoea; Insomnia; Nausea; Neck pain; Pain	FLU3~CONNAUGHT LABORATORIES~0984560~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1510E~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0116693	11/23/1998	MT	85.0	85		F	10/15/1998	Pt recv vax on 10/2/98; on 10/3/98 pt exp chills x 2dy, fever (100); tx=Tylenol; pt imp 10/15/98									Y	10/02/1998	10/03/1998	1	NONE	PUB	PUB	Bactrim, Synethcocal	Unproductive cough	High blood pressure	UNK~ ()~~~In patient	MT98026	1						1	Chills; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~E20188H~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116695	11/23/1998	FL	72.0	72		F	11/18/1998	pt c/o lt arm soreness, redness, swelling started about 2hr p/vax given lt arm swollen, warm to touch from shoulder to elbow per pt swelling, pain, redness decreased but it is still painful;										11/16/1998	11/16/1998	0	NONE	PUB	PUB	NONE	NONE	Epinephrine	pt exp soreness, redness, pain @ 8-12hr odl w/Td & Typhoid~ ()~~~In patient	FL98060	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0403H~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0116696	11/23/1998	TX	57.0	57		F	11/03/1998	raised 4cm area warm-red;									Y	11/01/1998	11/02/1998	1	NA	OTH	UNK		NA		~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0981800~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116697	11/23/1998	OK	50.0	50		F	11/06/1998	localized bruised @ inj site lt deltoid approx 35cm by 35cm;entire upper lt arm redness, swelling & soreness times 2wk;tx heating pad;									N	10/23/1998	10/24/1998	1	NONE	PUB	PUB	Synthyroid, Tenormin	NONE	hypothyroid;migraine h/a	NONE~ ()~~~In patient	OK9844	1						1	Ecchymosis; Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4988239~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~0939440~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0116699	11/23/1998	OK	43.0	43		M		area 10x15cm red, swollen, warm to touch, very sore lt deltoid to bicep, lasted 96hr took advil for 96hr;									Y	10/23/1998	10/23/1998	0	NONE	PUB	PUB	NONE	NONE	NA	NONE~ ()~~~In patient	OK9845	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4988239~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0906E~1~~RA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~0939440~2~~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0116703	11/23/1998	OH	40.0	40		F	11/06/1998	21OCT98 neck, chest area started to itch & broke out w/rash in these areas raised reddened fine type;rash still apparent & itching-same site-has not spread;to MD;										10/19/1998	10/21/1998	2		PUB	PUB	Micronase for diabetes;accolate for asthma	NONE	NONE	~ ()~~~In patient	OH98091	1						1	Pruritus; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~0977170~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116704	11/23/1998	WI	32.0	32		M	11/18/1998	5min p/vax pt sat in chair & shortly p/became unresponsive;sz-like activity obvious; turn on pt side immed ensuring safety & airway management;pt recovered 2min later;pt instructed to report incident to MD & not to drive;									U	11/05/1998	11/05/1998	0		PUB	PVT			pt stated this apppened once before p/a medication inj	~ ()~~~In patient		1						1	Condition aggravated; Convulsion; Stupor; Convulsion; Stupor	FLU3~CONNAUGHT LABORATORIES~0984540~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0984540~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0116705	11/23/1998	OH	43.0	42		F	11/10/1998	pt recv vax & 45min p/vax pt began w/dry cough & became hoarse;devel tightness in chest & fever of 100;took APAP & then napped;woke up feeling better;									Y	10/30/1998	10/30/1998	0	NONE	PUB	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	OH98095	1						1	Chest pain; Cough; Dysphonia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~0985920~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~MERCK & CO. INC.~0629H~3~~RA~HEP B (RECOMBIVAX HB)~1	USA		Influenza
0116707	11/23/1998	FL	21.0	21		F	11/20/1998	pt recv vax 19NOV98 11AM & stated got hot, began sweating & felt like passing out;states vomited a very small amount;had no sneezing, SOB, hives or swelling VS remained stable when checked every 5min for 30min;nausea/faintness was relieved									Y	11/19/1998	11/19/1998	0	NONE	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Dizziness; Hyperhidrosis; Nausea; Vasodilatation; Vomiting	FLU3~PARKDALE PHARMACEUTICALS~02888P~2~IM L~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116708	11/23/1998	CT	48.0	48		F	11/05/1998	about 18hr p/vax pt devel chills, fever (T101), muscle & joint aches, extreme fatigue, h/a lasting for 2 days;									Y	10/29/1998	10/29/1998	0	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	CT9903	1						1	Arthralgia; Asthenia; Headache; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0983320~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116709	11/23/1998	CT	56.0	56		F	11/05/1998	about 24hr p/vax pt devel h/a, chills, fever (T101, 102 oral), muscle & body aches, fatigue, gen malaise lasting 2 days;also devel 2 1/2inch area of induration, redness & tenderness @ vax site lasting 5 days;									Y	10/28/1998	10/29/1998	1	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	CT9904	1						1	Asthenia; Headache; Injection site hypersensitivity; Injection site mass; Injection site pain; Malaise; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0983320~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116711	11/23/1998	NY	41.0	41		F	10/26/1998	pt c/o both hands tingling, numbness, white in color;has recently completed a course of steroids;PMD was notified by employee;pt notified to notify infect control;									Y	10/20/1998	10/21/1998	1	NONE	PUB	UNK		per employee completed course of steroids		~ ()~~~In patient		1						1	Pallor; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0977210~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116713	11/23/1998	TX	44.0	44		M	11/17/1998	lt side of body was very sore day p/vax;also felt discomfort in breathing, upset stomach, chills & diarrhea that evening;pt feels that had a 48hr flu									Y	11/13/1998	11/14/1998	1	NA	PUB	PUB		NA	asthma	~ ()~~~In patient	TX98177	1						1	Chest pain; Chills; Diarrhoea; Dyspepsia; Influenza; Myalgia	FLU3~PARKDALE PHARMACEUTICALS~01698P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116714	11/23/1998	MD	49.0	49		F	11/09/1998	awakened by h/a @ 2Am or 3AM;cold sweats, dizziness, chills, vomited off & on until 7Am;felt weak, tired & disoriented & a sore arm;also admits to diarrhea;returned to work next day;									Y	10/26/1998	10/27/1998	1	NONE	PUB	PUB	NONE	NONE	hayfever	~ ()~~~In patient	MD98021	1						1	Chills; Confusional state; Diarrhoea; Dizziness; Headache; Hyperhidrosis; Myalgia; Vomiting	FLU3~PFIZER\WYETH~4988212~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116715	11/23/1998	TX	71.0	71		F	11/16/1998	pt recv vax 10NOV98 2PM & hoarseness occurred around 4PM;salt gargles, throat/cough drops condition lasted approx 4-5 days;									Y	11/10/1998	11/10/1998	0	NA	MIL	OTH	Prempro;Metophalol;Pravastatin	NONE	high blood	NONE~ ()~~~In patient		1						1	Dysphonia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116716	11/23/1998	WI	72.0	72		F		2 days p/vax pt woke w/the room spinning around;this persisted to a lesser degree for about 2wk;									Y	10/22/1997	10/24/1997	2		UNK	UNK				~ ()~~~In patient		1						1	Vertigo	FLU3~PFIZER\WYETH~4978141~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~442520~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0116717	11/23/1998	TX	63.0	63		F	11/17/1998	chills & fever 5PM;took advil;									Y	11/13/1998	11/13/1998	0	NA	OTH	PUB	NA			~ ()~~~In patient		1						1	Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~01698P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116718	11/23/1998	TX	53.0	53		F	11/17/1998	pain in rt arm throughout the weekend 14NOV-15NOV98;									Y	11/13/1998	11/14/1998	1	NOEN	PUB	PUB	NONE	NONE	NA	~ ()~~~In patient	TX98178	1						1	Pain	FLU3~PARKDALE PHARMACEUTICALS~01698P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116721	11/23/1998	MA	65.0	65		F	11/13/1998	woke up w/swelling around eyes, itching rash on chin which similar to what gets from sarcoidosis;									Y	10/14/1998	10/15/1998	1	NA	PUB	UNK	Estrogen, prozac, fosamax	NONE	NKA;medical condition sarcoidasis	~ ()~~~In patient		1						1	Condition aggravated; Face oedema; Pruritus; Condition aggravated	FLU3~CONNAUGHT LABORATORIES~0975790~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0975790~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0116732	11/23/1998	MI	70.0	70		F	11/09/1998	arm swollen, red, warm to touch, periphery of redness is blotchy;started 2-3hr p/vax given;last tetanus given 8yr ago, no rxn;c/o itching in reddened area;									Y	11/02/1998	11/02/1998	0		PUB	PUB	Synthroid	NONE	NONE	~ ()~~~In patient	MI98131	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4988204~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~0944780~3~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0116733	11/23/1998	MI	65.0	65		F	11/04/1998	approx 1hr p/vax rt deltoid became red, swollen, hot p/2hr area under arm & arm to elbow;also swollen, hot, red;pt applied ice & used motrin 2 days later redness is gone but whole arm to the elbow remains swollen;										11/02/1998	11/02/1998	0	NONE	PUB	PUB	synthroid;Premarin;Diazide	NONE	HTN	NONE~ ()~~~In patient	MI98132	1						1	Injection site hypersensitivity; Injection site oedema; Lymphadenopathy; Oedema peripheral; Vasodilatation	FLU3~PFIZER\WYETH~4988204~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~448188~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0116734	11/23/1998	MI	67.0	67		F	10/28/1998	awake during noc w/h/a, vomiting x2;dizzy when stands up									U	10/27/1998	10/28/1998	1		PUB	UNK	contact ocld med-last week	NONE	NONE	~ ()~~~In patient	MI98129	1						1	Dizziness; Headache; Vomiting	FLU3~PFIZER\WYETH~8013~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116744	11/24/1998	TX	47.0	47		M	10/27/1998	arrived @ ER via ambulance CPR in progress reported unconscious, unresponsive by family who called ambulance;CPR discontinued 815AM;no post mortem exam done;	Y	10/20/1998		Y					N	10/20/1998				PUB	PUB	unk	NONE	schizophrenia;pt brother states pt stated had been advised to have heart surgery;	unk~ ()~~~In patient	TX98164	1						1	Stupor; Syncope	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~0924000~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Results in Death	Influenza
0116747	11/24/1998	IL	74.0	74		F	11/12/1998	Pt recv vax on 11/2/98; on 11/6/98 pt exp encephalopathy, sleepiness, fever, stopped eating & drinking, matted/weepy eyes, relaxed arms; tx=I.V. hydration			Y	Y					N	11/02/1998	11/06/1998	4	UNK	PVT	OTH	Multiple	Multiple sclerosis	Multiple sclerosis	UNK~ ()~~~In patient		1						1	Anorexia; Dehydration; Encephalopathy; Hypotonia; Lacrimal disorder; Pyrexia; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0116749	11/24/1998	AL	66.0	66		M	11/19/1998	Pt recv vax on 11/6/98; 2 hr later pt exp soreness, fever, myalgia in arms & legs, renal failure, rhabdomyolysis			Y	Y	Y	3			N	11/06/1998	11/06/1998	0	BUN 43, Creat 3.6, ALT 413, AST 1125, CPK 117868, Serum phosphate 5.0	MIL	MIL	Phenasteride, Dixidocin	NONE	BPH	UNK~ ()~~~In patient		1						1	Alanine aminotransferase increased; Anaemia; Aspartate aminotransferase increased; Blood creatine phosphokinase increased; Blood creatinine increased; Blood urea increased; Coagulopathy; Myalgia; Myopathy; Pyrexia; Renal failure	FLU3~PFIZER\WYETH~4988247~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~124614~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0116750	11/24/1998	AZ	89.0	88		F	11/10/1998	pt exp disorientation, fever, chills, nausea, inc pulse rate, incontinence;				Y	Y	3			Y	10/14/1998	10/14/1998	0		OTH	PUB	Cipro;Xanax;Tuberculin by Parke Davis lot# 1418P given 14OCT98;	UTI		~ ()~~~In patient		1						1	Confusional state; Faecal incontinence; Nausea; Pyrexia; Tachycardia; Urinary incontinence	FLU3~CONNAUGHT LABORATORIES~0981810~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0116753	11/24/1998	MA	50.0	50		F	11/18/1998	Pt recv vax on 10/22/98; on 10/23/98 pt exp a mass at base of neck (right)				Y					Y	10/22/1998	10/23/1998	1	NONE	OTH	PUB	Premarin, Provera	NONE	NONE	NONE~ ()~~~In patient		1						1	Skin nodule	FLU3~CONNAUGHT LABORATORIES~0975780~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116759	11/24/1998	MI	31.0	31		F	11/19/1998	Pt recv vax on 10/19/98; on 10/20/98 pt exp red, erythema, warmth at vax site; tx=Benadryl & cold compresses				Y					Y	10/19/1998	10/20/1998	1	NONE	OTH	PVT	Progesterone IM	NONE	Allergic to Penicillin, Ampicillin, Amoxycillin, Compazine	UNK~ ()~~~In patient		1						1	Injection site hypersensitivity; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975770~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116763	11/24/1998	PA	15.0	15		F	11/18/1998	Pt recv vax on 11/4/98; on 11/7/98 pt exp fever, red/hot/painful arm; tx=Keflex; dx=cellulitis				Y					Y	11/04/1998	11/07/1998	3	UNK	PVT	PVT	Azmacort, Ventolin	NONE	Asthma	NONE~ ()~~~In patient		1						1	Cellulitis; Injection site hypersensitivity; Injection site pain; Pyrexia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20118GB~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1246H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0116764	11/24/1998	MN	41.0	41		F	10/30/1998	Pt recv vax on 10/29/98; 20 min later pt exp difficulty breathing, weakness, cold, crying, emotional; pt to E.R.; tx=oxygen				Y					Y	10/29/1998	10/29/1998	0	UNK	PUB	PUB	Thyroxine	NONE	Allergic to shrimp, crab, Penicillin, Codeine, EES, Benadryl, dust, smoke, fumes, colognes	NONE~ ()~~~In patient		1						1	Affect lability; Agitation; Asthenia; Chills; Dyspnoea; Hypoxia	FLU3~PARKDALE PHARMACEUTICALS~02298P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0116765	11/24/1998	NJ	61.0	61		F	11/18/1998	Pt recv vax on 10/15/98; on 10/16/98 pt exp swelling, erythema & tenderness at vax site; tx=Keflex; dx=cellulitis				Y					U	10/15/1998	10/16/1998	1	NONE	PVT	PVT	UNK	NONE	NONE	UNK~ ()~~~In patient		1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0975850~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~488175~1~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0116770	11/24/1998	TX	57.0	56		F	10/30/1998	Pt recv vax on 10/16/98; on 10/17/98 pt exp cellulitis of Rt arm w/ red, itching,swelling & fever; numb hands to neck; tx=Keflex				Y					N	10/16/1998	10/17/1998	1	UNK	PUB	PVT	UNK	NONE	4/98 Cartilage overgrowth	NONE~ ()~~~In patient	TX98168	1						1	Cellulitis; Injection site hypersensitivity; Paraesthesia; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975800~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0906E~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0116772	11/24/1998	NE	54.0	54		F	11/24/1998	pt recv vax 11NOV98 & had allergic rxn devel hives all over body;seen @ ER;				Y					Y	11/11/1998				PVT	PVT	Medrogel;propulsid;premarin;peauk;ASA propnandol		tetracycline-eosphageal reflux	~ ()~~~In patient		1						1	Hypersensitivity; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~02889~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~SMITHKLINE BEECHAM~242A4~3~IM~~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0116773	11/24/1998	TX	54.0	54		F	10/30/1998	dizzy, nausea w/in 10min of vax;arm swollen, bled into site;BP nl 164/94, pulse 94;9NOV follow/up call still swollen & bruised; has had heat & cold tx;									Y	10/30/1998	10/30/1998	0		PUB	PUB	ASA therapy	NONE	NONE	~ ()~~~In patient	TX98163	1						1	Dizziness; Ecchymosis; Hypertension; Injection site haemorrhage; Nausea; Oedema peripheral; Tachycardia	FLU3~CONNAUGHT LABORATORIES~0984540~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116775	11/24/1998	TX	85.0	85		F	10/14/1998	608hr p/vax devel soreness & swelling on upper part off arm;had fever took 2 ASA;BP inc so pt took xanax to get it down;temp was down to 100 @ bedtime;next morning fever was down;									Y	10/12/1998	10/12/1998	0	NONe	PUB	PUB		NONE		~ ()~~~In patient	TX98167	1						1	Hypertension; Injection site oedema; Injection site pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0975990~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0906E~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0116776	11/24/1998	TX	46.0	46		U	10/30/1998	23OCT98 redness around inj site, warm to touch, soreness, then turned into splotches which were warm to touch;Friday splotches spread to bilat legs & patches on posterior back area;									Y	10/22/1998	10/22/1998	0	NA	OTH	PVT	Daypro	NA		AN~ ()~~~In patient	TX98169	1						1	Injection site hypersensitivity; Injection site pain; Rash maculo-papular; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0971880~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116777	11/24/1998	TX	54.0	54		F	10/30/1998	swelling, itching, dizzy & woozy; on 2 1/2hr p/vax;BP 136/88									Y	10/30/1998	10/30/1998	0		PUB	UNK	Allegra, imitrex PRN;excedrine, premarin	NONE		NONE~ ()~~~In patient	TX98171	1						1	Dizziness; Hypertension; Oedema; Pruritus	FLU3~CONNAUGHT LABORATORIES~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116778	11/24/1998	TX	33.0	33		M	10/30/1998	tingling all over 9head to toe);ticklish;BP 118/72;									Y	10/30/1998	10/30/1998	0		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	TX98172	1						1	Paraesthesia	FLU3~CONNAUGHT LABORATORIES~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~UNKNOWN MANUFACTURER~~UNK~~RA~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0116779	11/24/1998	CA	79.0	79		F	11/18/1998	Pt recv vax on 10/20/98; on 11/13/98 pt exp whooping cough x 2 nights, body & teeth pain, flu-like sxs									Y	10/20/1998	11/13/1998	24	NONE	PUB	PVT	Diazepam, MVI, Forsegz	NONE	NONE	NONE~ ()~~~In patient		1						1	Cough; Dyspnoea; Influenza; Myalgia; Tooth disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116780	11/24/1998	MO	47.0	46		F	11/17/1998	Pt recv vax on 11/11/98; post vax pt exp itchy eyes, cough, respiratory stridor; bruising at vax site									Y	11/11/1998	11/11/1998	0	NONE	PUB	PVT	NONE	NONE	NONE	UNK~ ()~~~In patient		1						1	Conjunctivitis; Cough; Ecchymosis; Injection site hypersensitivity; Pruritus; Stridor	FLU3~PARKDALE PHARMACEUTICALS~00508P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116781	11/24/1998	OH	62.0	62		F	11/13/1998	Pt recv vax on 11/3/98; on 11/6/98 pt exp itchy, warm, discoloration of arm									U	11/03/1998	11/06/1998	3	UNK	PUB	OTH	Ecotrin, Procardia	NONE	Phenobartal, Cerebral palsy of left side, multiple myeloma	UNK~ ()~~~In patient		1						1	Pruritus; Skin discolouration; Skin nodule; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116783	11/24/1998	AR	46.0	46		F	11/12/1998	Pt recv vax on 11/4/98; 1 hr post vax pt exp vax site pain w/ swelling, whelps, raised; developed blisters in mouth; aching all over									Y	11/04/1998	11/04/1998	0	CBC-WNL; Divertigen Flu A -negative	PVT	PVT	Depoestinadial, Micalcin nasal spray, Propocet, Prednisone, Clarizopale, Prozac, Adiprox	Hematoma skin	Post polio Sgorgen's syndrome	UNK~ ()~~~In patient		1						1	Dermatitis bullous; Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~02198P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116784	11/24/1998	OR	43.0	43		F	11/19/1998	Pt recv vax on 11/12/98; 30 min later pt exp dizziness, vax site red & swollen, tongue numb, headache & tired; tx=Epinephrine									Y	11/12/1998	11/12/1998	0	NONE	OTH	PVT	Premarin	NONE	Carpel Tunnel Syndrome	UNK~ ()~~~In patient		1						1	Asthenia; Dizziness; Headache; Injection site hypersensitivity; Injection site oedema; Paraesthesia; Tongue disorder	FLU3~PFIZER\WYETH~4988235~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116785	11/24/1998	OH	67.0	67		F	11/09/1998	Pt recv vax on 10/2/98; post vax pt exp sore throat, cough & not feeling well (10/98); tx=Amoxicillin									N	10/02/1998			UNK	PVT	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Cough; Malaise; Pharyngitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116788	11/24/1998	MI	44.0	44		F	11/20/1998	Pt recv vax on 10/20/98; 1/2 hr later pt exp erythema, redness to vax site & fever x 8-10 day; tx=Benadryl & cold compress									Y	10/20/1998	10/20/1998	0	NONE	OTH	PVT	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Injection site hypersensitivity; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0975770~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116789	11/24/1998	MI	31.0	31		F	11/20/1998	Pt recv vax on 11/17/98; on 11/18/98 pt exp redness/erythema x 2-3 hr & nausea									Y	11/17/1998	11/18/1998	1	UNK	OTH	PVT	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Nausea; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975770~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116790	11/24/1998	MI	32.0	32		F	11/19/1998	Pt recv vax on 10/16/98; on 10/17/98 pt exp redness/erythema x1 day at vax site									Y	10/16/1998	10/17/1998	1	NONE	OTH	PVT	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Injection site hypersensitivity; Rash	FLU3~CONNAUGHT LABORATORIES~0975770~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116791	11/24/1998	MI				F	11/20/1998	Pt recv vax on 11/9/98; on 11/10/98 pt exp erythema/redness/fever at vax site x 1 wk									Y	11/09/1998	11/10/1998	1	UNK	OTH	PVT	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975770~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116792	11/24/1998	MS	52.0	52		F	11/18/1998	Pt recv vax on 11/17/98; on 11/18/98 pt exp redness, soreness, swelling & heat of vax site; joint pain, chills, fever x 2 day									Y	11/17/1998	11/18/1998	1	UNK	PVT	PVT	Univose	NONE	Hypertension, Allergic to Codeine, copper, Zinc & other metals	Pt exp same rx post Flu vax at age 42~ ()~~~In patient		1						1	Arthralgia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0990780~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116793	11/24/1998	MS	38.0	38		F	11/19/1998	Pt recv vax on 11/17/98; on 11/18/98 pt exp soreness/redness/swelling/itching of vax site									Y	11/17/1998	11/18/1998	1	NONE	PVT	PVT	Levathroid, Benadryl	NONE	Hypothyroid	UNK~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus	FLU3~CONNAUGHT LABORATORIES~0990780~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116794	11/24/1998	IL	79.0	79		M	11/16/1998	Pt recv vax on 11/13/98; on 11/14/98 pt exp right facial palsy w/ inability to close right eye, right side mouth droop									U	11/13/1998	11/14/1998	1	CT of head w/ contrast -negative (11/14/98)	OTH	PUB	Ferrous sulfate, Proventil inhaler	NONE	COPD	UNK~ ()~~~In patient		1						1	Facial palsy	FLU3~PFIZER\WYETH~4988204~6~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116795	11/24/1998	AK	42.0	42		M	11/16/1998	Pt recv vax on 11/6/98; 20 min post vax pt exp numb & tingling around mouth to cheeks & forehead, tachycardia; tx=Benadryl									Y	11/06/1998	11/06/1998	0	Pulse oximity 96%	MIL	MIL	Naprosyn	NONE	Allergic Penicillin	NONE~ ()~~~In patient		1						1	Paraesthesia; Paraesthesia oral; Tachycardia	FLU3~CONNAUGHT LABORATORIES~0981820~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116796	11/24/1998	MT	38.0	38		F	11/18/1998	Pt recv vax on 11/3/98; on same day pt exp redness & swelling									Y	11/03/1998	11/03/1998	0	NONE	PVT	PVT	Synthroid, Vancenase	NONE	Hx of Hodgkins disease-stage 2A, Hypothyroidism due to radiation, splenectomy	Pt exp fever & body rash post MMR vax at 25 yr old #4 dose~ ()~~~In patient		1						1	Oedema; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02298P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~0587H~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0116797	11/24/1998	HI	2.0	2	.0	F	11/18/1998	Pt recv vax on 11/13/98; on same day pt exp tenderness to vax site (LA)									Y	11/13/1998	11/13/1998	0	NONE	PVT	OTH	UNK	NONE	Ventricular septal defect	UNK~ ()~~~In patient		1						1	Injection site pain	FLU3~CONNAUGHT LABORATORIES~0975790~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1278E~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0116798	11/24/1998	MS	23.0	23		F	11/19/1998	Pt recv vax on 11/16/98; on same day pt exp red & swelling at vax site									Y	11/16/1998	11/16/1998	0	NONE	PUB	PUB	Birth control	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0990780~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0115544	11/25/1998	WI	26.0	25		F	11/19/1998	pt recv vax 6OCT98 & 12hr post vax pt became very ill, exp emesis, diarrhea, dehydration & chest pains;pt was reportedly adm to hosp for IV fluids;pt was on clear liquids until 10OCT reportedly feeling better by 9OCT taking med for nausea;					Y				Y	10/06/1998	10/07/1998	1		PUB	PVT		NONE		~ ()~~~In patient	U199800820	1						3	Myalgia; Vomiting; Chest pain; Dehydration; Diarrhoea; Malaise; Nausea; Vomiting; Chest pain; Dehydration; Diarrhoea; Malaise; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~0977180~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0977180~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~0977180~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Hospitalisation	Influenza
0116800	11/25/1998	CO	24.0	24		F	10/30/1998	Stevens Johnson's synd diffuse erythematous, general fine rash w/T102 3-4hr post vax;gross hematuria 24hr later w/vesicular rash, mucosa gen;no joint pain or swelling ;					Y	4			Y	10/13/1998	10/13/1998	0		PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	CO98055	1						1	Dermatitis bullous; Haematuria; Mucous membrane disorder; Pyrexia; Rash; Stevens-Johnson syndrome	FLU3~CONNAUGHT LABORATORIES~0973980~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0116801	11/25/1998	NJ	67.0	67		F	11/09/1998	pt expired w/in 24h of vax;no apparent allergic response;	Y	10/17/1998							N	10/16/1998	10/17/1998	1		PUB	PUB	Vasotec, lanoxin, coumadin, immodium PRN;insulin	NONE	CAD/diabetes	~ ()~~~In patient	NJ9827	1						1	Coronary artery disease; Diabetes mellitus; Unevaluable event	FLU3~CONNAUGHT LABORATORIES~0978660~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0871H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Results in Death	Influenza
0116803	11/25/1998	OK	64.0			M	11/16/1998	lab on 5NOV98 CBC platelet count of zero;pt adm to hosp;27OCT98 recv vax;			Y		Y				Y	10/27/1998	11/05/1998	9		UNK	UNK				~ ()~~~In patient		1						1	Antinuclear antibody; Dysphagia; Pain; Petechiae; Rash; Thrombocytopenia	FLU3~MEDEVA PHARMA, LTD.~E2008BFC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~454967~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA	Life Threatening,Hospitalisation	Influenza
0116808	11/25/1998	WI	37.0	37		F	11/13/1998	pt recv vax by noon, first itchy, watery eyes, congestion & cough;felt miserable in afternoon;				Y					Y	11/04/1998	11/04/1998	0	NONE	OTH	OTH	unk	NONE	possible fibromyalgia-have sx but not technically dx	NONE~ ()~~~In patient	FLU90121198	1						1	Cough; Lacrimal disorder; Malaise; Pruritus; Rhinitis	FLU3~PARKDALE PHARMACEUTICALS~00508P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0116809	11/25/1998	MA	68.0	67		F	11/06/1998	fever, achiness hands & fingers, bronchial cough;went to own MD;pt put on minocycline 2 doses then stopped made pt dizzy;				Y					Y	10/30/1998	11/01/1998	2		PVT	OTH		NONE	no heart, diabetes;does have bronchial asthma	~ ()~~~In patient		1						1	Bronchitis; Cough; Dizziness; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116810	11/25/1998	MA	61.0	61		F	11/06/1998	mark swelling from rt armpit to elbow red, warm to touch, hot &cold, possible cellulitis;applied ice & ibuprophen;				Y					N	11/03/1998	11/04/1998	1		PVT	PUB	Premarin;Prozac	NONE	NONE	NONE~ ()~~~In patient		1						1	Cellulitis; Chills; Injection site hypersensitivity; Injection site oedema; Lymphadenopathy; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0870H~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0116811	11/25/1998	MA	32.0	32		F	11/09/1998	started becoming ill on 1NOV98 w/h/a, achiness & fever 102-102.8;pt still has cough 9NOV98;no temp, c/o sl achiness;seen by MD 2NOV98 strep negative, urine test negative;				Y					Y	10/14/1998	11/01/1998	18	strep negative;urine test negative;	PUB	PUB		NONE		~ ()~~~In patient	MA9838	1						1	Cough decreased; Headache; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0975790~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116816	11/25/1998	FL	78.0	78		M	11/19/1998	large bright red area inj site w/full body rash;red area is swollen & warm to touch;				Y					Y	11/17/1998	11/18/1998	1	NA	PVT	PVT	Dilantin;Tenormin;procardia;Bentyl;Ecotrin	NA	allergy PCN	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975830~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454379~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0116820	11/25/1998	MD	50.0	50		F	11/16/1998	pt recv vax 5NOV98 approx 1130AM & late afternoon felt tingling all over & began to itch;used alcohol & had burning sensation, some swelling & then used calamine lotion;to hosp ER dx probably hives from vax;				Y						11/05/1998	11/05/1998	0		UNK	UNK				~ ()~~~In patient		1						1	Paraesthesia; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~0981820~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116822	11/25/1998	PA	62.0	62		F	10/29/1998	pt recv vax 28OCT98 & in the morning of 29OCT98 devel bilat swelling of facial cheeks w/erythema, h/a & nausea;lt arm was sl ecchymotic @ the inj site;				Y					Y	10/28/1998	10/29/1998	1		PVT	PUB	Premarin;vitamin B & E;dexamethorophan	NONE	PCN & Neurontin	NONE~ ()~~~In patient		1						1	Ecchymosis; Face oedema; Headache; Injection site reaction; Nausea; Rash	FLU3~MEDEVA PHARMA, LTD.~E20128GB~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0116823	11/25/1998	UT	69.0	69		F	11/06/1998	pt recv vax & reported red, firm, warm, very tender lt upper arm, redness & swelling migrated to lower 2/3 outer aspect of lt arm;									Y	10/19/1998	10/19/1998	0	NONE	PUB	PUB	Premarin;Synthroid;Dyazide;	NONE	diabetes, HTN, hypothyroid	~ ()~~~In patient	UT981820	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Oedema peripheral; Vasodilatation	FLU3~PFIZER\WYETH~498820~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0871H~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0116825	11/25/1998	AZ	50.0	50		F	10/23/1998	22OCT98 very sore arm on lt side @ inj site, achy 23OCT98;welts around site approx 6, still very achy, now gen achy denies fever;									U	10/21/1998	10/22/1998	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	AZ9846	1						1	Injection site hypersensitivity; Injection site pain; Myalgia	FLU3~PFIZER\WYETH~4988199~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1173E~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0116828	11/25/1998	MD	52.0	52		M		same day chill in body, then fatigue & chill red day;saw MD next day put on amoxicillin, took 2 days side leave;									Y	11/28/1998	11/28/1998	0	NONE	OTH	OTH	NONE	NONE	allergies-grass, some plants, some weeds;	NONE~ ()~~~In patient		1						1	Asthenia; Chills	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116833	11/25/1998	NY	62.0	61		F	11/02/1998	rt upper arm area of redness, hardness, heat, 4x4 painful;									Y	10/29/1998	10/30/1998	1	NONE	PUB	PUB		NONE		~ ()~~~In patient	NYS98031	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4988212~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~M030411~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0116834	11/25/1998	NY	70.0	70		F	10/16/1998	16OCT98 rt arm (pneumovax arm) red, warm to touch & painful;measures 5x5 localized redness 2 below shoulder & into inner aspect full ROM arm & fingers;+ capillary return;BP 122/70 radial pulse 88reg;T96.8 oral;									Y	10/15/1998	10/16/1998	1		UNK	UNK				NONE~ ()~~~In patient	NYS98032	1						1	Hypotension; Hypothermia; Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4988212~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~445636~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0116836	11/25/1998	MA	60.0	60		F	11/13/1998	pt describe rt deltoid as feeling achy, crampy in upper part of arm from elbow to shoulder;red x 1 days +- 2 in diameter, some itchiness;rt arm cont to be achy, crampy but is resolving (11 days);pt taking advil as needed;									U	11/02/1998	11/02/1998	0	NONE	PUB	PUB	Premarin	NONE	NONE	NONE~ ()~~~In patient	MA9841	1						1	Hypertonia; Injection site hypersensitivity; Injection site pain; Myalgia; Pruritus	FLU3~CONNAUGHT LABORATORIES~0978490~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~0960580~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0116838	11/25/1998	MA	42.0	42		F	10/29/1998	devel a swollen area @ inj site of 5 1/2cm, area hard, too c/o pain @ site 23OCT to 12cm, less red, not warm, very sensitive;									Y	10/21/1998	10/22/1998	1		PUB	PUB		NONE		pt exp inc swelling @ age 42w/hep B;~ ()~~~In patient	MA9839	1						1	Injection site mass; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0975790~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116839	11/25/1998	MA	29.0	29		F	11/03/1998	swelled, hard 2 area, hot, itchy @ deltoid lasted 4 days;(local reaction);no treatment;									Y	10/26/1998	10/27/1998	1	NONE	OTH	OTH	NONE	NONE	sensitive skin	pt son devel SOB, stiffened w/pertussis~ ()~~~In patient	MA9837	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975780~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116704	11/27/1998	WI	32.0	32		M	11/23/1998	pt recv vax 5NOV98 & 5min p/vax pt sat in chair & shortly p/became unresponsive;sz-like activity obvious;									Y	11/05/1998	11/05/1998	0		PUB	PVT			pt stated this happened once a/p/a med inj;	~ ()~~~In patient	U199800828	1						2	Condition aggravated; Convulsion; Stupor; Convulsion; Stupor	FLU3~CONNAUGHT LABORATORIES~0984540~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0984540~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0116878	11/27/1998	RI	50.0	50		F	11/24/1998	pt recv vax 20OCT98 & 25OCT98 pt exp edema of both legs, periorbital edema & nephrotic synd;As of 24NOV98 pt not yet recovered;				Y	Y	1			Y	10/20/1998	10/25/1998	5	Albutarin 2.4, kidney biopsy:minimal change disease;	PVT	UNK	Premarin	NONE	unspecified renal disease ongoing;	~ ()~~~In patient	U199800794	1						1	Face oedema; Nephrotic syndrome; Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~0968420~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0116881	11/27/1998	AL	30.0	30		M	11/20/1998	GBS & hosp;					Y		Y		N	10/30/1998	11/11/1998	12	NA	MIL	MIL	NONE	NONE	NONE	NA~ ()~~~In patient	AL9814	1						1	Guillain-Barre syndrome	FLU3~PFIZER\WYETH~4988247~2~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0116884	11/27/1998	NJ	6.0	6		M	11/20/1998	12NOV98 started w/redness @ inj site @ 430PM;4 circumference @ 104.5PM came to hosp w/redness 7 swelling noted @ rt arm circumference 26cm lt arm, 19cm site described in bed as erythematous, very tender, saem area indurated;					Y	1			Y	11/11/1998	11/12/1998	1	WBC 11.3;HCT 38.6;HGB 13.5;	PVT	OTH	Ritalin	well child	asthma, ADHD	NONE~ ()~~~In patient	FLU90161198	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~02198P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0116885	11/27/1998	MA	72.0	72		F		difficulty breathing, wheezing, hives, paleness, weakness, fast heart beat, dizziness, swollen glands behind head;				Y					N	11/28/1998	11/30/1998	2	regular emergency room tests	OTH	PUB	blood pressure	NONE	high blood pressure	~ ()~~~In patient		1						1	Asthenia; Asthma; Dizziness; Dyspnoea; Lymphadenopathy; Pallor; Tachycardia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0116886	11/27/1998	NY	73.0	73		F	11/20/1998	Pt recv flu vax 10/27/98. 10/29/98 pain & redness in rt eye.11/2/98-md visit,dx. episcleritis.10/27/98 sore throat w/ inflamed uvula that resolved in few hours. Feels & looks better, to see MD 12/9/98. Pt recv previous doses flu vax				Y					Y	10/27/1998	10/28/1998	1		PUB	OTH	none	none	none	none-slight soreness in arm~ ()~~~In patient		1						1	Conjunctivitis; Eye pain; Scleritis	FLUX~UNKNOWN MANUFACTURER~12262206~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0116887	11/27/1998	NC	75.0	75		F	10/25/1998	approx 10hr p/vax rt arm became swollen down to the elbow;the swelling remained & pt had redness & itching the next day;				Y					Y	10/22/1998	10/22/1998	0		PUB	PUB	Hytrin;Folic acid;MVI	NONE	NONE	~ ()~~~In patient	NC98051	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~CONNAUGHT LABORATORIES~0980580~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1510E~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0116894	11/27/1998	MD	65.0	65		F	10/27/1998	10/19/98 recvd vax. 10/20/98 pain & redness in rt arm& inc over several days at inj site. 10/22/98 dx w/cellulitis. rx w/ antibiotics.10/27/98  pink area @ site & not feeling well.11/2/98 arm better.				Y					Y	10/19/1998	10/20/1998	1		PUB	PUB		none		~ ()~~~In patient		1						1	Cellulitis; Injection site hypersensitivity; Injection site pain; Malaise	FLU3~MEDEVA PHARMA, LTD.~E20158HD~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~454378~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0116899	11/27/1998	NY	30.0	30		F	11/27/1998	pt called 2 days p/vax states rt upper arm reddened, very painful, warm to touch ordered amoxicillin;aldo DPH;pt is pregnant;									Y	11/23/1998	11/25/1998	2		PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4988209~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0868N~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0116900	11/27/1998	CA	74.0	74		F	11/25/1998	hives (red rash over face, accompanied by small hives);breath sounds, inc lobes present/clear;denies any other sx;no tx order;duration @ 24hr;									Y	11/17/1998	11/20/1998	3	NONE	PVT	UNK	Insulin;NPH;	diabetic	diabetic	~ ()~~~In patient		1						1	Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0116902	11/27/1998	MS	18.0	18		F	10/29/1998	pt recv vax 28OCT98 lt deltoid area returned today 29OCT w/a local rxn red raised area size of silver dollar, warm to touch;									Y	10/28/1998	10/28/1998	0		PUB	PVT				~ ()~~~In patient	MS98031	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20158HG~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0116909	11/27/1998	VA	56.0	56		F	11/20/1998	local & transient pain down lt arm;inj site warm & swollen 7 days p/vax given;tx warm compresses & naproxen;sx are beginning to subside;										11/10/1998	11/13/1998	3		PUB	OTH	Premarin;Diazide	NONE	asthma 9allergy induced) dgenerative disc disease;	NONE~ ()~~~In patient	VA98080	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4988224~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116910	11/27/1998	MN				F		reported exp chills, dizziness, nausea, h/a, muscle aches w/in 3hr of vax;									Y	11/02/1998	11/02/1998	0	NONE	PVT	PVT		NONE		~ ()~~~In patient		1						1	Chills; Dizziness; Headache; Myalgia; Nausea	FLU3~PFIZER\WYETH~4988220~4~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116911	11/27/1998	MN	34.0	34		F	11/23/1998	alleges rt lymph (axillary) tenderness;									Y	11/03/1998			NONE	PVT	PVT	Cimetidine	NONE	allergic to compazine, codeine, cephalosporin, PCN, & sulfa;	~ ()~~~In patient		1						1	Pain	FLU3~PFIZER\WYETH~4988220~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116912	11/27/1998	MN	45.0	45		M	11/23/1998	states fever & chills Saturday 1AM 7NOV98;h/a from 7NOV98  11AM-8PM;									Y	11/06/1998	11/07/1998	1		PVT	UNK		NONE	NONE	NONE~ ()~~~In patient		1						1	Headache; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~01698P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116913	11/27/1998	MN	55.0	55		F	11/23/1998	alleges onset suddenly of fever, chills, & nasal congestion;24hr later nasal sx but fever & chills subsided;									Y	11/05/1998	11/05/1998	0	NONe	PVT	PVT		NONE	PCN & vitamins;	~ ()~~~In patient		1						1	Pyrexia; Rhinitis	FLU3~PARKDALE PHARMACEUTICALS~01698P~3~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116914	11/27/1998	NJ	68.0	68		F	10/23/1998	devel fever 102 & chills on 10OCT98 9PM;by 11OCT98 3PM fever gone, hives appeared on opposite arm;									Y	10/09/1998	10/10/1998	1		UNK	UNK		NONE	NONE			1						1	Chills; Pyrexia; Urticaria; Chills; Pyrexia; Urticaria; Vaccine positive rechallenge	FLUX~UNKNOWN MANUFACTURER~0977180~UNK~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~0977180~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0116915	11/27/1998	NJ	61.0	61		F	10/23/1998	22OCT98 immed devel hematoma p/vax;23OCt98 ecchymotic area the size of tennis ball;edema subsided;									Y	10/22/1998	10/22/1998	0		PUB	PUB		NONE		unk~ ()~~~In patient		1						1	Ecchymosis; Haemorrhage; Oedema	FLU3~CONNAUGHT LABORATORIES~0977180~4~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116916	11/27/1998	NJ	70.0	70		M	10/30/1998	felt mild weakness about 10min p/vax;pulse feels nl 60;23NOV98 reported weakness subsided that day of report;									Y	10/30/1998	10/30/1998	0		PUB	UNK		NONE	unk	unk~ ()~~~In patient	9833	1						1	Asthenia	FLU3~CONNAUGHT LABORATORIES~0977180~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116921	11/27/1998	NC	65.0	65		F	10/26/1998	Recvd vax, 10/24/98 swelling & inflammation in Lt upper arm. On 10/26/98 had reddened area at inject site 11cmx7cm, used APAP, meds & ice. Pt notified HD 10/26/98, began to resolve 10/26/98.									Y	10/23/1998	10/24/1998	1	NA	PUB	PUB	SUDAFED	NA		NA~ ()~~~In patient	NC98052	1						1	Injection site hypersensitivity; Injection site inflammation; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~0975770~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~448516~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0098454	11/30/1998	IA	62.0			F	11/16/1998	pt recv vax & devel GBS characterized by pain, myasthenia, asthenia & myopathy;			Y		Y				U	02/26/1997	02/26/1997	0		OTH	OTH	unk	unk		~ ()~~~In patient	898321024A	1						2	Asthenia; Guillain-Barre syndrome; Myasthenic syndrome; Myopathy; Pain	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Life Threatening,Hospitalisation	Influenza
0116127	11/30/1998	NY	3.0	3		F	11/11/1998	pt recv vax 29SEP98 & next day pt drowsy & lethargic;taken to ER;mom told it could be rxn to flu vax;1OCT98 4AM began screaming for mom;child shaking mom reported sz;pt vomited, lost consciousness & stopped breathing;acute hem pancreatitis;	Y	10/01/1998		Y					N	09/29/1998	09/30/1998	1	amylase 2125 u/l;lipase >8000;	PVT	OTH	Zerit;Videx	unk	HIV infect	~ ()~~~In patient	898316053A	1						2	Abdominal pain; Blood amylase increased; Infection; Laboratory test abnormal; Pancreatitis haemorrhagic; Somnolence; Stupor; Vomiting; Abdominal pain; Apnoea; Blood amylase increased; Coma; Convulsion; Enzyme abnormality; HIV infection; Pancreatitis haemorrhagic; Pharyngitis; Somnolence; Syncope	FLU3~PFIZER\WYETH~4988207~2~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4988207~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Results in Death	Influenza
0116721	11/30/1998	MA	65.0	65		F	11/13/1998	Pt recv vax on 10/14/98; on 10/15/98 pt exp swollen eyes, itchy rash on chin x 8dy									Y	10/14/1998	10/15/1998	1	NONE	PUB	OTH	Estrogen, Prozac, Fosamax	NONE	Sarcoidosis	UNK~ ()~~~In patient	MA9843	1						2	Condition aggravated; Face oedema; Pruritus; Condition aggravated	FLU3~CONNAUGHT LABORATORIES~0975790~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0975790~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0116927	11/30/1998	MO				F	10/30/1998	pt recv vax & w/in 48hr devel a severe site rxn which was described as cellulitis;tx w/IV ATB;					Y				U	10/21/1998				OTH	OTH	unk	unk		~ ()~~~In patient	898307084A	1						1	Cellulitis; Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~454956~UNK~A~~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0116937	11/30/1998	TN	46.0	46		F	11/06/1998	Pt recv vax on 11/4/98; 7 hr later pt exp sweat&chills, abdominal pain, vomiting, diarrhea, tingling & numbness in hands & lips, confused thinking, diplopia, headache, wheezing, tachycardia;tx=Epinephrine,Benadryl,Phenergan,DecadronIV				Y					Y	11/04/1998	11/04/1998	0	NONE	PVT	PVT	Cefzil, Entex L.A.	Sinusitis	Allergic to Codeine, Hypothyroidism, HRT	UNK~ ()~~~In patient		1						1	Abdominal pain; Asthma; Confusional state; Diarrhoea; Diplopia; Hyperhidrosis; Paraesthesia; Vomiting	FLUX~UNKNOWN MANUFACTURER~0983290~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0116942	11/30/1998	MA	56.0	56		F	11/24/1998	Pt recv vax on 10/29/98; on 10/30/98 pt exp shortness of breath, wheezing & hives; tx=Albuterol, Epinephrine, Solumedrol, Benadryl, Tagamet, Ventolin inhaler				Y					Y	10/29/1998	10/30/1998	1	UNK	PUB	PUB	NONE	NONE	ASA, Chemical allergy, Asthma, Egg sensitivity & pesticides	UNK~ ()~~~In patient		1						1	Asthma; Condition aggravated; Dyspnoea; Urticaria	FLU3~CONNAUGHT LABORATORIES~0975780~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116943	11/30/1998	IA	7.0	7		F	11/24/1998	Pt recv vax on 11/17/98; on 11/19/98 pt exp hives, swelling, pain & redness at vax site				Y					Y	11/17/1998	11/19/1998	2	NONE	PVT	PVT	Atrohist, Vancenase	NONE	NONE	UNK~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Urticaria	FLU3~CONNAUGHT LABORATORIES~0983290~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~444076~1~IM~RL~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0116944	11/30/1998	OH	79.0	79		F	11/24/1998	Pt recv vax on 11/13/98; 3 hr post vax pt exp shaking, shortness of breath & chills x1 day				Y					Y	11/13/1998	11/13/1998	0	UNK	PUB	PUB	UNK	UNK	Allergic to Penicillin & Sulfa	UNK~ ()~~~In patient	OH98107	1						1	Chills; Dyspnoea; Tremor	FLU3~CONNAUGHT LABORATORIES~0984530~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116945	11/30/1998	NC	32.0	32		F	11/04/1998	Pt recv  vax on 11/4/98; 1 hr post vax pt exp chest tightness, difficulty breathing, choking feeling, nausea, vax site swelling/itching; tx=Benadryl				Y					Y	11/04/1998	11/04/1998	0	BP 140/78; R-16; P-100	PVT	PUB	UNK	Latex rash on skin	NONE	UNK~ ()~~~In patient	NC98065	1						1	Chest pain; Dysphagia; Dyspnoea; Hypertension; Hypoventilation; Injection site hypersensitivity; Injection site oedema; Nausea	FLU3~MEDEVA PHARMA, LTD.~E20088FC~2~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0116948	11/30/1998	TN	32.0	32		F	11/04/1998	Pt recv vax on 11/3/98; 5 min post vax pt exp throat tight, chest tight, vomiting, joint&muscle aches,  fever (101), dizzy, red/indurated area				Y					Y	11/03/1998	11/03/1998	0	CBC	PVT	PUB	Ortho Tricycline, Vitamin E, Vitamin C, Vitamin B complex	NONE	NONE	NONE~ ()~~~In patient		1						1	Arthralgia; Chest pain; Dizziness; Injection site oedema; Laryngospasm; Myalgia; Pyrexia; Skin nodule; Vomiting	FLU3~CONNAUGHT LABORATORIES~0984560~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~452367~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0116949	11/30/1998	TN	19.0	19		F	11/05/1998	Pt recv vax on 10/27/98; on same day pt exp swollen, tender, warm LA, fever, chills, sweat; tx=Prednisone & ice pack to area				Y					Y	10/27/1998	10/27/1998	0	UNK	OTH	PUB	UNK	NONE	Allergic to Hydrocodone- palpitations, nausea, vomitting	NONE~ ()~~~In patient		1						1	Hyperhidrosis; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0984560~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~452367~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0116952	11/30/1998	CO	78.0	77		M	11/24/1998	Pt recv vax on 10/19/98; on 10/28/98 pt exp flu sxs of achy, chills, sweaty, stomach ache, weak body x 3dy									Y	10/19/1998	10/28/1998	9	UNK	OTH	OTH	UNK	NONE	UNK	Pt recv flu vax every yr; exp same rx~ ()~~~In patient		1						1	Asthenia; Chills; Dehydration; Dyspepsia; Hyperhidrosis; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116954	11/30/1998	NC	15.0	15		M	11/24/1998	Pt recv vax on 11/19/98; on 11/21/98 pt exp red, hot, painful area, fever (101), lethargic & dec energy									Y	11/19/1998	11/21/1998	2	UNK	PVT	OTH	NONE	Sore throat	Sinus infections	UNK~ ()~~~In patient		1						1	Asthenia; Hypokinesia; Pain; Pyrexia; Skin nodule; Somnolence; Vasodilatation	FLU3~PFIZER\WYETH~4988203~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1095H~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0116956	11/30/1998	TX	11.0	11		M	11/24/1998	Pt recv vax on 11/10/98; post vax pt exp dizziness & pale color x few min									Y	11/10/1998	11/10/1998	0	NONE	PVT	PVT	NONE	NONE	Allergic to Ceclor & Septra (rash); Hx of asthma	Pt recv flu vax last yr; exp feeling tired & dizziness~ ()~~~In patient		1						1	Dizziness; Pallor	FLU3~CONNAUGHT LABORATORIES~0989920~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116963	11/30/1998	MD	78.0	78		F	11/18/1998	Pt recv vax on 10/22/98; on 11/10/98 pt exp pain of right knee & calf, difficulty walking, vomiting & diarrhea									N	10/22/1998	11/10/1998	19	NONE	PUB	PUB	Triamterene, Atenol	NONE	Possible Alzheimer's -per husband; Hypertension	UNK~ ()~~~In patient	MD98022	1						1	Arthralgia; Diarrhoea; Gait disturbance; Hypokinesia; Myalgia; Pain; Vomiting	FLU3~PFIZER\WYETH~4988212~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116964	11/30/1998	PA	29.0	29		F	11/24/1998	Pt recv vax on 11/11/98; 10 min post vax pt exp chest tight & dizziness									Y	11/11/1998	11/11/1998	0	NONE	OTH	OTH	UNK	UNK	Allergic to Penicillin, Tetracycline, Eymycin, Bactramycin, Sudafed	UNK~ ()~~~In patient		1						1	Anxiety; Chest pain; Dizziness	FLUX~UNKNOWN MANUFACTURER~0978490~1~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0116967	11/30/1998	VA	30.0	30		M	10/30/1998	Pt recv vax on 10/26/98; on 10/27/98 pt exp sore/ unable to move/ red/ swollen/ warm Rt arm, headache, became sick w/ fever (102)									Y	10/26/1998	10/27/1998	1	NONE	PUB	PUB	NONE	NONE	Allergic to Penicillin	UNK~ ()~~~In patient	VA98079	1						1	Headache; Hypokinesia; Injection site hypersensitivity; Injection site mass; Injection site oedema; Myalgia; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4988212~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~454957~UNK~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0116968	11/30/1998	IN	53.0	53		M	11/06/1998	Pt recv vax on 10/22/98; on 10/25/98 pt exp fever, achiness, disturbed sleep, sore throat, productive cough, diarrhea, stomach cramps, dec appetite & headache x 1 wk									Y	10/22/1998	10/25/1998	3	NONE	OTH	OTH	UNK	NONE	NONE	NONE~ ()~~~In patient		1						1	Abdominal pain; Anorexia; Cough; Diarrhoea; Insomnia; Myalgia; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0969600~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116969	11/30/1998	IN	41.0	41		F	11/02/1998	Pt recv vax on 10/29/98; on 11/01/98 pt exp nausea &vomiting, stomach cramps, fever (99-100), headache, sore throat, weak &dizzy									Y	10/29/1998	11/01/1998	3	NONE	PUB	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Abdominal pain; Asthenia; Dizziness; Headache; Pharyngitis; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~0969600~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116970	11/30/1998	MA	33.0	33		F	11/05/1998	Pt recv vax on 11/3/98; on 11/4/98 pt exp urticaria x 48 hr; tx=Benadryl									Y	11/03/1998	11/04/1998	1	NONE	MIL	PVT	UNK	Ovarian problems	NONE	UNK~ ()~~~In patient		1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~0981850~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116971	11/30/1998	MA	35.0	34		F	11/04/1998	Pt recv vax on 10/22/98; on 10/24/98 pt exp raised erythema									Y	10/22/1998	10/24/1998	2	WBC-15.7	PUB	OTH	UNK	NONE	NONE	UNK~ ()~~~In patient	MA9842	1						1	Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~0975790~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116977	12/01/1998	CA	61.0	61		M	11/18/1998	Guillain-Barre nerve synd;acute idiopathic polyneuritis;had weakness, put on respirator;legs & arms paralyzed;pt hosp 15NOV97;			Y		Y	175	Y	Y	N	10/28/1997	11/05/1997	8		PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome; Neuritis; Paralysis; Respiratory disorder	FLU3~CONNAUGHT LABORATORIES~7F81883~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0116979	12/01/1998	WI	33.0	33		F	11/16/1998	pt recv vax & approx 6hr later seen in ER for SOB, wheezing, cough, chest tightness progressively worse over past 2hr;had facial puffiness on admission to ER;02 sat 100% on room air;given epi, solumedrol, albuterol & DPH;dx allerg rxn;				Y						11/12/1998	11/12/1998	0	12NOV98 pulse oximetry physical exam for allergic rxn;	UNK	UNK			allergies codeine, sulfa, percoden, environmental;	~ ()~~~In patient		1						1	Asthma; Chest pain; Cough; Dyspnoea; Face oedema; Hypersensitivity	FLU3~MEDEVA PHARMA, LTD.~E20258KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0116981	12/01/1998	KY	65.0			M	11/17/1998	pt devel post vax myelitis;					Y				Y				unk	PUB	PUB				~ ()~~~In patient		1						1	Myelitis	FLU3~PFIZER\WYETH~4988208~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0116983	12/01/1998	VA	34.0	34		F	10/18/1998	feeling very tired & weak;switching back & forth from sweating spells, then chills;				Y					N	10/16/1998	10/17/1998	1	CBC-nl	MIL	MIL	Flutamide,birth control, prilecek	NA	seasonal, environmental	NA~ ()~~~In patient		1						1	Asthenia; Chills; Hyperhidrosis	FLU3~CONNAUGHT LABORATORIES~0970170~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116987	12/01/1998	NY	41.0	41		F	11/24/1998	17NOV98 pt presented to ER w/throat lightening, wheezing, tachycardia & dizziness;sx lasted hr;pt stated anxious about the rxn;DPH given;				Y					Y	11/17/1998	11/17/1998	0	NONE	PUB	UNK		NONE		~ ()~~~In patient		1						1	Asthma; Dizziness; Laryngospasm; Tachycardia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0116992	12/01/1998	MA	39.0	39		F	11/24/1998	back pain+ numbness in arms/legs since recv vax;				Y					N	10/08/1998	10/08/1998	0	20NOV98 neurology said-has protruding lumbar disc & old herniated cervical disc;	OTH	PVT	Klonopin;Melleril;Zoloft;Tegretol;	NONE	pt c/o back pain in AUG98 p/being assaulted			1						1	Back pain; Condition aggravated; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0975790~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0116996	12/01/1998	CT	41.0			F	11/20/1998	10 days p/vax site of inj became warm, red, indurated & 7-10 small vesicles devel @ inj site;5 days later satellite vesicles devel;											11/01/1998		cult of vesicle was negative for herpes virus;	UNK	UNK	NONE			~ ()~~~In patient		1						1	Dermatitis bullous; Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~PFIZER\WYETH~4988203~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116997	12/01/1998	CT	66.0			F	11/20/1998	pt devel rxn to vax;@ inj site 10 days later devel indurated, warm & painful arm & 2-3 vesicles devel @ inj site few days later;satellite vesicles appeared profound to inj site on upper shoulder;											11/01/1998			UNK	UNK				~ ()~~~In patient		1						1	Dermatitis bullous; Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4988203~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0116999	12/01/1998	MA	66.0	66		F	11/25/1998	pain temp? trouble breathing, body aches, pain in arm & shoulder, ached all over, red localized;									Y	10/24/1998	10/24/1998	0	NONE	PUB	PUB	Diltianem;PRemarin;Prilosec;Levbid;Zonax;Effexor;		severe spastic colon, COPD	~ ()~~~In patient		1						1	Dyspnoea; Injection site hypersensitivity; Myalgia; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0975780~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~087011~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0117004	12/01/1998	CA	60.0	59		F	11/24/1998	Pt recv vax on 11/18/98; on 11/19/98 pt exp nausea, headache, toothache, vomiting x 3dy, tired &chills, sore/red/raised/warm area									Y	11/18/1998	11/19/1998	1	NONE	OTH	PVT	Tylenol, Lipator, Estrogen patch	NONE	High cholesterol, Back & shoulder pain	NONE~ ()~~~In patient		1						1	Headache; Myalgia; Nausea; Oedema; Pain; Tooth disorder; Vasodilatation; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E20298LA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0117005	12/01/1998	MD	57.0	57		F	11/24/1998	Pt recv vax on 11/16/98; on 11/17/98 pt exp achiness & tiredness, headache, runny nose, chills, cough, crackling ears, no appetite										11/16/1998	11/17/1998	1	UNK	PUB	OTH	Allegra, Serevent, Flonase, Proventil-HFA, Flovent	UNK	UNK	UNK~ ()~~~In patient		1						1	Anorexia; Asthenia; Chills; Cough; Ear disorder; Headache; Myalgia; Rhinitis	FLU3~MEDEVA PHARMA, LTD.~E20118GA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0117006	12/01/1998	CA	76.0	76		M	11/16/1998	Pt recv vax on 10/14/98; on same day pt exp swelling, tenderness, redness of Rt arm; tx=Hydroxyzine									Y	10/14/1998	10/14/1998	0	UNK	PVT	PVT	Cardizem, Isopdil, Ecotrin	ASHD	Allergic to Penicillin	UNK~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema	FLU3~PFIZER\WYETH~4988214~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~362967~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0117007	12/01/1998	NC	54.0	54		M	11/19/1998	Pt recv vax on 11/19/98; 2 min post vax pt exp dizziness, tx=rest 1 hr-dizziness persisted									U	11/19/1998	11/19/1998	0	BP 142/88, Pulse 64 bpm	OTH	PVT	NONE	NONE	NONE	UNK~ ()~~~In patient		1						1	Dizziness; Hypertension	FLU3~CONNAUGHT LABORATORIES~0988280~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117008	12/01/1998	WI	82.0	82		F	11/23/1998	Pt recv vax on 10/19/98; on same day pt exp LA pain; 1 mo later pt exp left hand/wrist swelling									N	10/19/1998	10/19/1998	0	CBC, Uric acid, Sedrate, Lyme titer	PVT	PVT	UNK	NONE	Ht mx, venous stasis le, OHF	UNK~ ()~~~In patient		1						1	Oedema peripheral; Osteoarthritis; Pain	FLU3~PFIZER\WYETH~4988220~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0117009	12/01/1998	OR	49.0	49		M	11/23/1998	Pt recv vax on 11/19/98; on 11/20/98 pt exp itching (hands, feet, neck), hot skin w/ goose bumps									Y	11/19/1998	11/20/1998	1	UNK	OTH	OTH	Imipramine, Glucotrol XL	UNK	NIDDM, Hypertension	UNK~ ()~~~In patient		1						1	Pruritus; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4988200~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0117010	12/01/1998	TN	21.0	21		M	10/24/1998	Pt recv vax on 10/14/98; on 10/15/98 pt exp swelling of LA to chest; red streaks to red mass at vax site x 6 day; fever (101); chills x 4 day; tx=Advil & ice pack									Y	10/14/1998	10/15/1998	1	NONE	PVT	PVT	D.A. chewable, Nasacort	NONE	Cerebral palsy, Environmental allergies, Apnea	UNK~ ()~~~In patient		1						1	Injection site hypersensitivity; Oedema; Oedema peripheral; Pyrexia; Skin striae	FLU3~CONNAUGHT LABORATORIES~0975770~7+~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0670H~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0117012	12/01/1998	OH	41.0	40		M	11/27/1998	Pt recv vax on 10/28/98; on 10/29/98 pt exp muscle soreness of legs; headache x 3 day									Y	10/28/1998	10/29/1998	1	UNK	OTH	PVT	Antihistamines OTC	NONE	Various environment allergies	UNK~ ()~~~In patient		1						1	Headache; Myalgia	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0117021	12/02/1998	MA	30.0	30		M	11/20/1998	Pt recv vax on 11/10/98; on same day pt exp red/swollen vax site-LA, nausea, vomiting, fever, sweats; dx=Staph infection; tx=I.V. antibiotics & PO antibiotic				Y					Y	11/10/1998	11/10/1998	0	Staph infection	PUB	PUB	UNK	NONE	NONE	UNK~ ()~~~In patient	MA9844	1						1	Hyperhidrosis; Infection; Injection site hypersensitivity; Injection site oedema; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1389E~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0117026	12/02/1998	NY	57.0	57		F	11/27/1998	Pt recv vax on 11/12/98; on 11/13/98 pt exp chills, fever, muscle soreness, joint pain, upset stomach, difficulty walking & standing x 72 hr									Y	11/12/1998	11/13/1998	1	UNK	OTH	OTH	Premarin, Buspar, Nortryptoline	NONE	Bronchiectasis			1						1	Arthralgia; Dyspepsia; Gait disturbance; Hypokinesia; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0117030	12/03/1998	KY	28.0	28		F	12/02/1998	circulatory collapse;anaphylaxis;lethargy, tachycardia, P 120, red rash on lower extremities;			Y		Y	1			Y	11/12/1998	11/12/1998	0	basic metabolic panel potassium low 2.7, co2 low 19.2;EKG sinus tachycardia w/sinus arrythmia;	PUB	OTH	NONE	nONE	dairy products allergy	~ ()~~~In patient		1						1	Anaphylactoid reaction; Arrhythmia; Electrocardiogram abnormal; Hypokalaemia; Rash; Respiratory alkalosis; Shock; Tachycardia	FLU3~CONNAUGHT LABORATORIES~0988300~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0117040	12/03/1998	TX	35.0	34		F	11/30/1998	Pt recv vax on 11/9/98; on 11/11/98 pt exp nausea, chills & sweats x 4 day; fatigue & body aches x 1 wk				Y					Y	11/09/1998	11/11/1998	2	NONE	PUB	PUB	Allergy injection-11/13; Birth control pills; Claritin	NONE	Tavist D allergy	UNK~ ()~~~In patient	TX98182	1						1	Asthenia; Chills; Hyperhidrosis; Hypothermia; Myalgia; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0117046	12/03/1998	SC	75.0	75		M	10/30/1998	Pt recv vax on 10/29/98; on same day pt exp pain/ redness/ swelling/warmth w/ dec movement of Rt arm vax site; headache; fever (102F); wheezing;BP elevated; runny nose;tx=ice& heat, elevate,rest- Tylenol, Benadryl,I.V.antibiotics,Augmentin				Y					Y	10/29/1998	10/29/1998	0	Chest X-ray-negative	PUB	PUB	NONE	NONE	Some asthma years ago	UNK~ ()~~~In patient	SC98074	1						1	Asthma; Cellulitis; Headache; Hypertension; Hypokinesia; Hypotonia; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0980580~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0664E~1~SC~RA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~0963390~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0117047	12/03/1998	SC	69.0	69		M	11/30/1998	Pt recv vax on 11/23/98; on 11/29/98 pt exp chills, fever (103.4), nausea, vomiting, stomach cramps									Y	11/23/1998	11/29/1998	6	NONE	PUB	PUB	Antibiotic -UTI, BP meds	NONE	NONE	UNK~ ()~~~In patient	SC98084	1						1	Abdominal pain; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~0984550~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117048	12/03/1998	NY	39.0	39		M	11/29/1998	Pt recv vax on 11/4/98; 7 hr post vax pt exp tingling; swollen eyes									Y	11/04/1998	11/04/1998	0	NONE	OTH	PVT	NONE	NONE	Grass pollen, dust			1						1	Face oedema; Hypersensitivity; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0981790~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117050	12/03/1998	IL	49.0	48		F	11/30/1998	Pt recv vax on 11/5/98; 4 hr post vax pt exp fever, chills, sweats & body aches, dehydration & drained									Y	11/05/1998	11/05/1998	0	UNK	OTH	OTH	UNK	NONE	NONE	UNK~ ()~~~In patient		1						1	Asthenia; Dehydration; Hyperhidrosis; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0117053	12/03/1998	CO	76.0	76		F	11/30/1998	Pt recv vax on 10/29/98; on 10/30/98 pt exp red/rash/sore of LA x 1 wk									Y	10/29/1998	10/30/1998	1	NONE	PVT	PVT	Calan SR	Superficial thrombophlebitis	Allergic to Tolectin, Keflex, Sulfa, Penicillin	~ ()~~~In patient		1						1	Injection site hypersensitivity; Myalgia; Rash	FLU3~CONNAUGHT LABORATORIES~0977180~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454979~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0117057	12/03/1998	DE	71.0	71		F	11/24/1998	Pt recv vax on 10/6/98; 8 hr post vax pt exp chills, nausea, dry heaves, sweating, headache, ankle pain,  hot welt area of Rt arm									U	10/06/1998	10/06/1998	0	NONE	OTH	PUB	Aspirin	NONE	NONE	UNK~ ()~~~In patient	DE9806	1						1	Arthralgia; Chills; Hyperhidrosis; Pain; Urticaria; Vasodilatation; Vomiting	FLU3~CONNAUGHT LABORATORIES~0981800~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~444068~2~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0117062	12/04/1998	OR	59.0	59		M	12/02/1998	pt recv vax & was adm to hosp;pt was reported to have GBS sx which also exp 3month prev;f/u revealed pt had sx of weakness, constipation-secondary to pain & dec food intake in late JUL98;also tremors;10NOV98 pt intubated;					Y	43			N	10/20/1998	11/20/1998	31	NONE	OTH	OTH	Agon, clonidine, ferrous sulphate, furosemide	see box 19	GBS, chronic renal failure, demyelinating neuropathy	~ ()~~~In patient	MPI982025	1						1	Condition aggravated; Gastrointestinal disorder; Guillain-Barre syndrome; Hypoxia; Lung disorder; Neuropathy; Stupor	FLU3~MEDEVA PHARMA, LTD.~E20138GB~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0117063	12/04/1998	PA	46.0	46		F	11/24/1998	pt recv vax 26OCT98 & same day PM around 8PM had flushed, aching from mid chest up to head;noticed spontaneous hearing loss in lt ear & became dizzy & nauseated;				Y				Y	U	10/26/1998	10/26/1998	0	MRI brain, multiple hearing test;CBC/diff CH2/sed rate, thyroid panel, RPR/ANA;FTA-ABS	PVT	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	FLU90181198	1						1	Deafness; Dizziness; Myalgia; Nausea; Pain; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02888P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Disabling	Influenza
0117065	12/04/1998	MI	50.0	50		F	11/30/1998	unable to move lt shoulder @ 90 degree angle;no redness, edema or drainage;				Y					N	11/09/1998	11/09/1998	0	shoulder x-ray	PVT	PVT	unk	NONE	asthma	NONE~ ()~~~In patient	FLU91011198	1						1	Hypokinesia	FLU3~PARKDALE PHARMACEUTICALS~02998P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0117068	12/04/1998	CA	87.0	87		M	11/16/1998	COPD w/exacerbation;resp distress;expired 15NOV98 @ hosp;adm to hosp 14NOV98;	Y	11/16/1998							N	11/13/1998	11/14/1998	1		OTH	PVT		NONE frail-depressed	18OCT98 resp infect-sx free 28OCT98	NONE~ ()~~~In patient		1						1	Apnoea; Cardiac arrest; Dyspnoea; Lung disorder; Right ventricular failure	FLUX~UNKNOWN MANUFACTURER~~7+~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0117071	12/04/1998	MD	77.0	77		F	11/09/1998	later in the day p/vax felt blah & achy w/sl runny nose;relieved sl by APAP but need to repeat each time it wore off;11 days later began w/h/a & atrial fibrillation;18NOV98 severe muscle aches all over;dx PMR;				Y					U	10/26/1998	10/28/1998	2	elevated sed rate 112/per pt other lab work unk & not reported	PUB	PUB	Coumadin;Hyzaar;Corgard;Lasix;Pravachol;Prd;	NONE	atrial fibrillation, HTN	NONE~ ()~~~In patient	MD98023	1						1	Atrial fibrillation; Headache; Malaise; Myalgia; Red blood cell sedimentation rate increased; Rhinitis	FLU3~PFIZER\WYETH~4988212~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0117072	12/04/1998	IL	76.0	76		F	12/01/1998	3hr p/vax pt devel severe pain in hips, feet, knees, calves of legs & top of thighs got worse over 2wk 20OCT98;Saw MD dx as arthritis;rx med;				Y					N	10/01/1998	10/01/1998	0		PUB	PUB		NONE	NONE	~ ()~~~In patient	IL98090	1						1	Arthritis; Myalgia	FLU3~CONNAUGHT LABORATORIES~0975850~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117077	12/04/1998	NM	23.0	23		M	10/08/1998	asymptomatic soft palate & anterior tonsillar pillar, vesicles/ulcerations;questionable soft palate submucosal hyperplasia;1st noted 4 days p/2nd shot;				Y					Y	09/24/1998	09/28/1998	4		MIL	MIL	NONE	NONE	past history of seasonal allergic rhinitis	~ ()~~~In patient		1						1	Mouth ulceration; Mucous membrane disorder; Pharyngitis	ANTH~MICHIGAN DEPT PUB HLTH~FAV030~2~~~ANTHRAX (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4988247~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0117079	12/04/1998	TX	41.0	41		M	11/12/1998	approx 4hr p/vax exp irritated eyes, feeling of having something caught in throat, swollen tongue then approx 7hr felt achy & had temp of 99.5;									Y	11/11/1998	11/11/1998	0	no lab work done	OTH	UNK	skin ointmnet	NONE	hx of rhinitis	pt exp rxn @ 28yr old w/Td~ ()~~~In patient	TX98174	1						1	Conjunctivitis; Laryngospasm; Myalgia; Pyrexia; Tongue oedema	FLU3~PARKDALE PHARMACEUTICALS~01698R~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0117081	12/04/1998	WY	2.0	2	.2	F	11/30/1998	28OCT98 day of vax later @ home exp rash/redness @ site of inj;also hives on chest & back lasted for 3 days;behavior-hyperactive;30OCT98 vomiting;taken to MD on 31OCT98;									Y	10/28/1998	10/28/1998	0		PUB	UNK	NONE	NONE	allergy to PCN	~ ()~~~In patient	WY9824	1						1	Hyperkinesia; Injection site hypersensitivity; Urticaria; Vomiting	FLU3~PFIZER\WYETH~4988200~1~IM~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0117082	12/04/1998	OH	44.0	44		F	11/11/1998	pt felt ill (weak, tired) day p/vax;6NOV98 rash bilat on both axilla;rash cont down side;itchy;allerg rxn to the vax;									Y	11/02/1998	11/06/1998	4		OTH	UNK	NONE	NONE	unk	NONE~ ()~~~In patient	OH98098	1						1	Asthenia; Injection site hypersensitivity; Malaise; Pruritus; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~0985870~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117083	12/04/1998	OH	25.0	25		F	11/13/1998	pt had local soreness @ inj site;next day p/vax inj area on axilla became swollen & tender to touch for 2 days then swelling subsided;									Y	11/09/1998	11/10/1998	1		PUB	PUB	NONE	sl cold	NONE	NONE~ ()~~~In patient	OH98099	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0987670~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117086	12/04/1998	MD	39.0	39		M	11/13/1998	2 days p/vax pt devel a low grade fever 99.7, myalgias (esp arms & legs also feet) described as aching & hot, diarrhea;denied nasal congestion or other resp sx;									Y	11/09/1998	11/11/1998	2	NA	OTH	UNK		NONE	allergies: bee stings, various pollens/molds, animal dander	~ ()~~~In patient		1						1	Diarrhoea; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0972880~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117087	12/04/1998	MD	31.0	31		F	10/15/1998	14OCt98 pt noted red lump @ site of inj;also hot to the touch;describes as same rxn site as when recv tetanus shot JUN98;began to feel tired & congested (head);sore throat;red lump @ inj site;aches;										10/13/1998	10/14/1998	1		OTH	UNK	OTC sudafed	NONE	allergic to biaxin, mold;codeine;sunscreen	pt exp tetanus 11MAY98 w/Td booster~ ()~~~In patient		1						1	Asthenia; Injection site hypersensitivity; Injection site mass; Myalgia; Pharyngitis; Rhinitis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0972860~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117088	12/04/1998	MD	46.0	46		F	10/14/1998	head congestion, swelling in throat, chills, fever 99.5, generalized, malaise, myalgias, arthralgias beginning 2-3 hr p/vax;									Y	10/13/1998	10/13/1998	0		OTH	PVT	NONE	NONE	cats, dusty pollen			1						1	Arthralgia; Influenza; Laryngospasm; Malaise; Myalgia; Pyrexia; Rhinitis; Sinusitis	FLU3~CONNAUGHT LABORATORIES~0972860~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117091	12/04/1998	MD	68.0			M	12/02/1998	severe lumbosacral myalgia about 3 days p/vax 3NOV98;on the 24NOV recurrence w/severe labyrinthitis (including vertigo, nystagmus & nausea);									Y				NA	PVT	PVT	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Back pain; Myalgia; Nausea; Nystagmus; Vertigo; Vestibular disorder	FLU3~CONNAUGHT LABORATORIES~0975790~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117098	12/04/1998	NV	44.0	44		F	11/21/1998	pt recv vax 6NOV98 & felt strange;severe chills, unable to warm up;T101-took aleve x 1tab;7NOV98 woke up sweating;took APAP & woke up feeling very tired;									Y	11/06/1998	11/06/1998	0	NONE	PVT	OTH	Estrace	wek post op hysterectomy	4wk post op hysterectomy	NONE~ ()~~~In patient		1						1	Asthenia; Hyperhidrosis; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0985900~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116235	12/07/1998	NY	66.0	66		M	10/30/1998	Pt recv vax on 10/27/98; 4 hr post vax pt exp swelling, redness & pain on motion										10/27/1998	10/27/1998	0	NONE	OTH	OTH	UNK	UNK	NONE	UNK~ ()~~~In patient		1						2	Oedema; Pain; Vasodilatation; Oedema; Pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~449100~UNK~IM~~PNEUMO (PNU-IMUNE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~PFIZER\WYETH~449100~UNK~IM~~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0117102	12/07/1998	KY	1.3	1	.3	M		according to surgeon pt had sterile abscess;there was no growth from cult;father stated was size of hen egg;whole leg swollen red, hot to touch; was seen by MD;					Y	1				11/13/1998	11/20/1998	7	cult negative	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	KY980048	1						1	Abscess; Skin nodule; Vasodilatation	DTAP~PFIZER\WYETH~455726~4~IM~RA~DTAP (ACEL-IMUNE)~1|FLU3~CONNAUGHT LABORATORIES~0981800~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0516H~4~IM~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0230H~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Hospitalisation	Influenza
0117103	12/07/1998	FL	65.0			M	11/17/1998	pt had anaphylactic type rxn w/resp arrest;					Y	1			Y					PVT	PVT	Serevent MDi;allopinol	COPD, asthma		~ ()~~~In patient		1						1	Anaphylactoid reaction; Apnoea	FLU3~CONNAUGHT LABORATORIES~0984350~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0117104	12/07/1998	WI	52.0	52		F	11/30/1998	devel swelling of tongue;acute angioedema;tx epi & solumedrol, pred;					Y	1			Y	11/16/1998	11/17/1998	1	allergy-egg negative;	OTH	OTH		NONE	ASA, sulfa, PCN, flunase, macrodantin, codeine, theodur, tomatoes, peppers, spices, nuts;			1						1	Angioneurotic oedema; Tongue oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0117105	12/07/1998	MA	50.0	50		F	12/04/1998	pt recv vax 20OCT98 & on 26OCT98 persistent h/a devel-increasing in 5NOV98;devel tingling rt arm & lt eye swollen;MRI-neg					Y	5			N	10/20/1998	10/26/1998	6		PUB	PUB		NONE	NONE	NONE~ ()~~~In patient		1						1	Eye pain; Face oedema; Haemorrhage; Headache; Paraesthesia; Peripheral vascular disorder	FLU3~CONNAUGHT LABORATORIES~975790~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0117112	12/07/1998	CO	52.0	51		F	10/22/1998	swelling, redness, pain below inj site, temp of 100;pt reported when was hosp last DEC for resp problems they did give pt a pneumonia shot & pt had forgotten about it;				Y					Y	10/20/1998	10/20/1998	0		PUB	PUB		NA		NONE~ ()~~~In patient	CO98054	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E20188HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1508E~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0117116	12/07/1998	TN	40.0	40		F	11/23/1998	pt recv vax 19NOV98 1145AM returned 12:05Pm stating throat is tight;coughing;checked by MD lungs clear;given med improved p/15min;				Y					Y	11/19/1998	11/19/1998	0	NA	OTH	PUB	Allegra	NONE	asthma-allergy to eggs-has recv flu shot for 15 or more years	NONE~ ()~~~In patient		1						1	Cough; Laryngospasm	FLU3~CONNAUGHT LABORATORIES~0984560~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117120	12/07/1998	WI	41.0	41		F	11/30/1998	palms of hands itchy, red, feet felt hot, throat felt itchy;progressed go gen flushing, felt hot;noticed pulse more rapid;took DPH;hep lock inserted, DPH given IV solumedrol given;pred given;				Y					Y	11/11/1998	11/11/1998	0	egg & latex allergy tests negative;	PUB	UNK		NONE		~ ()~~~In patient		1						1	Pharyngitis; Pruritus; Tachycardia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0984580~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117123	12/07/1998	GA	48.0	48		F	11/30/1998	waxing & waning urticaria w/in 4-5 days p/vax;felt throat closing up morning of 27NO98;saw MD;30NOV worse urticaria;case discussed w/dermatologist;				Y						11/13/1998	11/18/1998	5		PVT	PVT	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Laryngospasm; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~02888P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0117127	12/07/1998	MA	39.0	39		M	11/09/1998	15OCT numbness & pain lt arm & numbness of index, middle & third fingers;dx radiculitis;				Y					Y	10/14/1998	10/15/1998	1	MRI & x-RAY cerivcal spine & lt arm;	PUB	PUB		NONE		~ ()~~~In patient	MA9845	1						1	Laboratory test abnormal; Neck pain; Neuropathy; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117128	12/07/1998	MA	68.0	67		M	10/17/1998	pt had diff breathing & confusion immed p/vax;pt was transported by ambulance to ER; MD stated pt had vasovagal rxn but not d/t vax;				Y					Y	10/17/1998	10/17/1998	0	NONE	PUB	PUB	unk	unk	hx of vasovagal rxn	unk~ ()~~~In patient	MA9846	1						1	Confusional state; Dyspnoea; Syncope	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1389E~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0117129	12/07/1998	OH	49.0	49		M	11/19/1998	30OCT98 c/o diplopia, rt facial numbness;pt is diabetic; tested blood sugar-was WNL; referred to MD;also seen other referred to clinic for consult;c/o muscle aches, n/v;				Y						10/29/1998	10/30/1998	1	Cat Scan-lab work;	OTH	PUB	Vtamins, insulin;	NONE	diabetic x 25yr	NONE~ ()~~~In patient	OH98103	1						1	Diplopia; Myalgia; Paraesthesia; Vomiting	FLU3~CONNAUGHT LABORATORIES~0978670~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117132	12/07/1998	CO	24.0	23		F	10/23/1998	pt recv vax 2Pm & 330PM had rash;about 9:30-10:00 went to ER;had sx of hives, pruritus, dyspnea, vomiting, coughing, confusion, h/a;				Y					Y	10/22/1998	10/22/1998	0		PUB	PUB	Proventil	NKA	NKA	~ ()~~~In patient	CO98050	1						1	Confusional state; Cough; Dyspnoea; Headache; Pruritus; Rash; Urticaria; Vomiting	FLU3~PFIZER\WYETH~4988216~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0117133	12/07/1998	MO	39.0	39		M	10/29/1998	3hr p/vax lungs felt congested;4hr tongue began to swell;given DPH w/in 1hr problems subsided;				Y					Y	10/21/1998	10/21/1998	0		OTH	PVT			NKA	~ ()~~~In patient	MO98076	1						1	Rhinitis; Tongue oedema	FLU3~CONNAUGHT LABORATORIES~0984560~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117134	12/07/1998	TN	47.0	47		M	11/23/1998	rash on face & chest, shoulders x 1wk;went to PMD 21NOV98 shot depo-medrol;				Y					Y	11/16/1998	11/17/1998	1	NONE	PUB	PUB	NONE	NONE	NKDA	~ ()~~~In patient	TN98053	1						1	Rash	FLU3~MEDEVA PHARMA, LTD.~E20138GB~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0117138	12/07/1998	GA	55.0	54		F	11/19/1998	woke up next morning p/vax, runny nose, achy, low grade fever-now has chest congestion hast talked w/PMD & ATB have been prescribed;				Y					U	11/09/1998	11/10/1998	1	NONE	PUB	PUB	Prinivil, Proventil inhaler	NONE	inc BP, cesthrora	NONE~ ()~~~In patient	GA98120	1						1	Lung disorder; Myalgia; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0975850~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117139	12/07/1998	GA	63.0	63		M	10/28/1998	pain, redness, swelling lt deltoid muscle inner axilla down to mid lt forearm;red streak w/o edema;T101-102;				Y					U	10/16/1998	10/16/1998	0		PUB	PUB	NONE;routine DPH	NONE		NONE~ ()~~~In patient	GA98113	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Pyrexia; Skin striae	FLU3~CONNAUGHT LABORATORIES~0969610~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0304H~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0117140	12/07/1998	GA	43.0	43		F	10/23/1998	reaction to pneumovax & flu vax;pt recv vax 19OCT98 in lt arm;used Ibuprofen & moist heat;lt arm swollen above elbow approx 7cm red, hot to touch;cellulitis  to PMD:				Y					Y	10/19/1998	10/19/1998	0	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	GA98110	1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4988208~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1542E~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0117141	12/07/1998	GA	62.0	61		F	10/21/1998	lt arm from just above elbow to shoulder is red, swollen & hot;cellulitis to PMD today;				Y					Y	10/14/1998	10/15/1998	1	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	GA98109	1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4988208~4~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1542E~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0117146	12/07/1998	GA	26.0	26		F	10/27/1998	indurating of 5.1cm x 3.8cm, heat et pain following vax;									U	10/26/1998	10/27/1998	1		PUB	OTH	NONE	NONE	NONE	~ ()~~~In patient	GA98111	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0969610~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117147	12/07/1998	GA	73.0	73		F	10/27/1998	swelling, hot, achy, sore rt arm;advised pt to apply cold compresses & f/u w/pvt MD if condition worsens;									U	10/26/1998	10/26/1998	0		PUB	UNK	blood pressure meds;premarin;andrex	NA	allergy;codeine	~ ()~~~In patient	GA98112	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0969610~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0304H~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0117148	12/07/1998	GA	48.0	48		F	10/29/1998	pt recv vax & noted 4inch x 4 inch area;where pneumonia vax given;area is rashy w/streaks has fever in arm & physical fever-area is raised-swollen;									Y	10/28/1998	10/29/1998	1		PUB	PUB	Premarin	NONE	NA	~ ()~~~In patient	GA98114	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pyrexia; Skin striae	FLU3~PFIZER\WYETH~4988208~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1247H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0117149	12/07/1998	GA	28.0	28		F	11/09/1998	1105AM p/having blood work & vax pt fainted;1110AM had another fainting spell;VS 110/70, P66, R16;pt alert & oriented;									Y	11/09/1998	11/09/1998	0	OTBS 94	PUB	PUB	Loestrin	NA	NONE	NA~ ()~~~In patient	GA98115	1						1	Hypotension; Hypoventilation; Syncope	FLU3~CONNAUGHT LABORATORIES~0975850~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117151	12/07/1998	GA	56.0	56		F	11/16/1998	pt returned to clinic approx 10min p/vax;pt has approx 2 1/2 x 2 1/2 x 1 1/2 swollen area on rt arm @ inj site;approx 1/8 area of blue bruising noted @ inj site;									U	11/16/1998	11/16/1998	0	NONE	PUB	PUB	denied	denies	denies	denies~ ()~~~In patient	GA98117	1						1	Ecchymosis; Injection site oedema; Injection site reaction	FLU3~CONNAUGHT LABORATORIES~0975850~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117152	12/07/1998	GA	43.0	43		F	11/17/1998	2 days p/vax a goose egg came up on rt arm it's red, hot & tender to touch;advised to see PMD;									U	11/12/1998	11/14/1998	2	NONE	PUB	PUB	Paxil, Relafen, zyrtec	NONE	NONE	NONE~ ()~~~In patient	GA98118	1						1	Pain; Skin nodule; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975850~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~444073~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0117155	12/07/1998	MO	54.0	54		F	11/10/1998	Pt recv vax on 11/5/98; 3 hr post vax pt exp cough, tight/squeaky chest, stiff neck, sore vax site until noon 11/6/98									Y	11/05/1998	11/05/1998	0	NONE	PUB	PUB	Hormone	NONE	Allergic to Penicillin, various trees & weeds	UNK~ ()~~~In patient	MO98077	1						1	Asthma; Condition aggravated; Cough; Injection site pain; Nuchal rigidity	FLU3~CONNAUGHT LABORATORIES~098330~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117159	12/07/1998	CO	47.0	47		F	10/08/1998	Pt recv vax on 10/1/98; post vax pt exp cellulitis									Y	10/01/1998			NONE	PUB	PUB	UNK	Chronic pain	Wheelchair bound, multiple joint problems, obesity	UNK~ ()~~~In patient	CO98049	1						1	Cellulitis; Skin nodule	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1510E~1~SC~LA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~0944780~UNK~IM~LL~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0117164	12/07/1998	NC	60.0	60		F		diarrhea & h/a w/in 24hr;h/a lasted over 1wk;									Y	11/17/1998				PUB	PVT		NONE	NONE	~ ()~~~In patient		1						1	Diarrhoea; Headache	FLU3~MEDEVA PHARMA, LTD.~20098GB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0117165	12/07/1998	NC	46.0	46		F	11/24/1998	h/a x 3 days;extreme fatigue x 3 days;chills, sweats, felt achy, sick;									Y	11/16/1998	11/16/1998	0		PUB	PVT		NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Chills; Headache; Hyperhidrosis; Malaise; Myalgia	FLU3~MEDEVA PHARMA, LTD.~20098GB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0117166	12/07/1998	NC	55.0	55		U		p/24hr fatigue, washed-out, h/a;									Y	11/16/1998				PUB	PVT				~ ()~~~In patient		1						1	Asthenia; Headache	FLU3~MEDEVA PHARMA, LTD.~20098GB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0117167	12/07/1998	PA	30.0			F	11/12/1998	c/o weird feeling in throat w/perceived difficulty getting adequate air;VS 122/86, 116;pt declined hosp eval;no dysphagia									U	11/11/1998	11/11/1998	0		OTH	OTH		denied	denied	~ ()~~~In patient		1						1	Dyspnoea; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~0984630~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117170	12/07/1998	OH	60.0	60		M	11/19/1998	raised red blotches w/itching on rt belt line of waist p/vax;p/vax rash on lt deltoid under lt arm & on chest, today 19NOV98 c/o itching, red, noted deltoid upper back under lt arm on chest belt line;c/o rash on thighs & knees;									U	11/10/1998	11/11/1998	1		PUB	PUB	ASA;B complex;Multi vitamin;E vitamin	NONE	NKA	NONE~ ()~~~In patient	OH98104	1						1	Lymphadenopathy; Pruritus; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~0978670~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117171	12/07/1998	OH	31.0	31		F	11/25/1998	1-2hr p/shot eyes itchy, tightness in chest, coughing, hives on chest;DPH about 5-6oclock d/t coughing, SOB;next day throat & flu-like sx;									Y	11/19/1998	11/19/1998	0		PUB	PVT	NONE	NONE	hx of allergics-used to get shots, until 2yr ago but has recently;seen inc of old allergies-grass, beesting, etc;	pt exp itching @ site w/flu vax;~ ()~~~In patient	OH98105	1						1	Chest pain; Cough; Influenza; Pharyngitis; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~0984570~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117172	12/07/1998	OH	45.0	45		F	11/23/1998	area around lt deltoid became edematous & itchy;hives appeared on deltoid area 7 lt shoulder area;									Y	11/20/1998	11/20/1998	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	OH98106	1						1	Injection site oedema; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~0988270~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117173	12/07/1998	CA	66.0	66		F	11/30/1998	pain @ site of inj persisting 7wk p/vax;also c/o tingling in fingers which initially occurred more than it does presently but still bothers pt;between lt shoulder & elbow had dull ache;now has tingling sensation only;									Y	10/06/1998	10/12/1998	6	NONE	PUB	PUB	Lotensin;Tenormin;Xanax;Indapamide	NONE	HTN	NONE~ ()~~~In patient	CA980127	1						1	Injection site pain; Myalgia; Neuralgia; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E20178HC~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0117175	12/07/1998	NJ	26.0	25		F		swelling, throbbing, redness around area of inj, soreness in elbow, shoulder & hand of that arm (lt);redness & swelling about 2 inches in diameter;									Y	11/18/1998	11/19/1998	1		OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia	FLU3~CONNAUGHT LABORATORIES~0981840~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117176	12/07/1998	MN				F	12/02/1998	pt exp a variety of non-specific sx p/vax according to report;sx include fatigue, panic feeling, adrenalin rash, h/a, dizzy;has seen MD & psych providers on a few med for mitral valve & panic disorder dx NOV98;									U	10/27/1998	10/27/1998	0	variety of labs/bloodwork have been nl per pt;	PVT	PVT	unk		unk;NOV98 dx w/mitral valve prolapse;	unk~ ()~~~In patient		1						1	Agitation; Asthenia; Dizziness; Headache	FLU3~CONNAUGHT LABORATORIES~0983310~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117177	12/07/1998	MO	56.0	56		F		low temp, felt very tired & 930PM woke up w/hives from bottom of feet up to waist, itching legs, swollen but could have been from scratching them;took 2 DPH & fell asleep;woke in morning feeling fine-no side effects;									Y	10/28/1998	10/28/1998	0		UNK	UNK				~ ()~~~In patient		1						1	Asthenia; Oedema peripheral; Pruritus; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0117181	12/07/1998	NC				F	11/25/1998	pt recv vax 19OCT98 & states passed out twice, was cold & clammy w/a tight feeling in chest;further exam revealed a localized erythematous & edematous area @ inj site on rt deltoid;										10/19/1998	10/20/1998	1	NA	UNK	UNK			NONE	~ ()~~~In patient		1						1	Chest pain; Chills; Hyperhidrosis; Injection site hypersensitivity; Injection site oedema; Syncope	FLU3~PFIZER\WYETH~4988208~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0117182	12/07/1998	FL	34.0	34		F		w/in 24hr of vax devel partial facial paralysis;dx bell's palsy;										10/28/1998	10/29/1998	1		UNK	UNK	NA		NONE			1						1	Facial palsy	FLU3~CONNAUGHT LABORATORIES~0981850~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117188	12/08/1998	VA	67.0	66		F	12/03/1998	pt recv vax 6OCT98 & pt raked leaves & next morning pt woke w/extreme muscle soreness & stiffness;pt was unable to lift lt arm or use it;rt arm was not affected;bursitis vs trauma;								Y	Y	10/06/1998	10/07/1998	1	OCT98 diagnostic radiology-no visible damage;	OTH	PVT			unk	No relevant data;~ ()~~~In patient	WAES98101008	1						1	Bursitis; Hypertonia; Hypokinesia; Injury; Myalgia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0871H~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0117192	12/08/1998	OH	58.0	58		M	12/01/1998	pt recv vax 30OCT98 & pt exp swelling on the lt side of face, rt shoulder, & both hands as well as shoulder & joint pain;pt sought unspecified med attention;3NOV98 results of CBC count WNL pt erythrocyte sed rate had inc to 108;				Y					U	10/30/1998	10/31/1998	1	3NOV98 CBC count WNL;erythrocyte sedimentation 108;	PVT	PVT	Plavix;Monopril;Lasix;Amaryl;Lopressor;Ultran;K-DUR;Rezulin;		diabetes mellitus;hypertension;	No relevant data;~ ()~~~In patient	WAES98110344	1						1	Arthralgia; Face oedema; Oedema peripheral; Osteoarthritis; Red blood cell sedimentation rate increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0117201	12/08/1998	IL	76.0	76		F	12/03/1998	pt face swollen including upper & lower lips;pain @ inj site;				Y					N	12/02/1998	12/02/1998	0	NONE	PVT	OTH	Vasotec	HTN	HTN	NONE~ ()~~~In patient	FLU91021198	1						1	Face oedema; Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~00508P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0117206	12/08/1998	HI	33.0	33		F	12/01/1998	Pt recv vax on 11/17/98; on 11/26/98 pt exp febrile illness w/ fever (104.5) x 3dy; 11/27/98 exp cough, coryza, sore throat; 11/29/98 pt exp erythema, maculopapular rash from head to extremities				Y					Y	11/17/1998	11/27/1998	10	UNK	MIL	MIL	UNK	NONE	Hx of adult respiratory disorder syndrome	UNK~ ()~~~In patient		1						1	Cough; Pharyngitis; Pyrexia; Rash maculo-papular; Rhinitis	FLU3~PFIZER\WYETH~4988328~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|MMR~MERCK & CO. INC.~0152H~UNK~SC A~~MEASLES + MUMPS + RUBELLA (MMR I)~1	USA	Emergency room visit	Influenza
0117207	12/08/1998	OR	27.0	26		F		Pt recv vax on 10/27/98; on 10/28/98 pt exp bruised, swollen, warm, red streak of vax site-LA				Y					Y	10/27/1998	10/28/1998	1	UNK	MIL	MIL	NONE	NONE	NONE	UNK~ ()~~~In patient		1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Skin striae; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~RA~HEP A (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0117209	12/08/1998	VT	32.0	32		F	12/01/1998	Pt recv vax on 11/23/98; 3 min post vax pt exp red, warm, swollen vax site; hives on chest, neck; chest tight; tx=Benadryl, Epi kit				Y					Y	11/23/1998	11/23/1998	0	NONE	PUB	PUB	UNK	NONE	Asthma	UNK~ ()~~~In patient	MA9847	1						1	Chest pain; Injection site hypersensitivity; Injection site oedema; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975780~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117214	12/08/1998	NY	71.0	71		M		Pt recv vax on 10/21/98; on 10/23/98 pt exp pleurisy; pleural effusion									Y	10/21/1998	10/23/1998	2	Chest X-ray, CBC	PVT	PVT	UNK	NONE	NONE	UNK~ ()~~~In patient		1						1	Pleural disorder; Pleural effusion	FLU3~CONNAUGHT LABORATORIES~0981810~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1094H~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0117215	12/08/1998	NH	63.0	63		M	12/01/1998	Pt recv vax on 10/6/98; on 10/7/98 pt exp achy & sick feeling; 10/30/98 muscle weakness; 12/2/98 exp swollen glands & ear discomfort									U	10/06/1998	10/07/1998	1	NONE	PVT	PVT	Trazodone, Allopurinol	NONE	High blood pressure, spinal fusion, gout	NONE~ ()~~~In patient	NH98019	1						1	Ear pain; Lymphadenopathy; Malaise; Myalgia; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~0988270~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117217	12/08/1998	NY	34.0	34		F	10/19/1998	pt arm became itchy, red, & swollen, area swollen & sore was approx egg size & warm to touch, went to ER 12:00;tx was taken DPH;pt refused because of large dose @ 745PM;DPH taken & heat applied to area for 3hr;									Y	10/15/1998	10/17/1998	2	NONE	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4978141~4~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0117243	12/09/1998	NC	62.0	62		F	10/22/1998	devel a rash w/itching;entire lt arm & lt arm axilla pit area affected;sx devel approx 6-7hr p/vax;rash lasted 12-24hr;pt took hydroxyzine HCL tablet 1hr p/ discovered rash to stop the itching;itching stopped 1-2hr later, rash remained;									Y	10/09/1998	10/09/1998	0	NONE	PUB	PUB	Synthroid;Ibuporfen, Premarin, Beconase, Vitamins, Agysterin, lgucosaminal	NONE	DPH, dolophine	NA~ ()~~~In patient	NC98069	1						1	Lymphadenopathy; Pruritus; Rash	FLU3~MEDEVA PHARMA, LTD.~20198HA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0117245	12/09/1998	NC	3.0	3		M	10/27/1998	devel blanching irregular reticular (lacy)-patterned hyperemic lesions on both deltoid areas which were not raised but was sl warm to the touch;									Y	10/26/1998	10/26/1998	0	NA	PUB	PUB	albuterol for inhalation;tx PRN	allergic rhinitis	h/o asthma	~ ()~~~In patient	NC98067	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975790~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454381~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0117247	12/09/1998	SC	68.0	68		M	12/01/1998	pt reports onset of swelling in posterior rt arm on 24NOV98 in the vicinity of pneumococcal vax;swelling cont to an approx 10 x 3 area above the elbow & was accompanied by soreness & sl redness;									Y	11/24/1998	11/24/1998	0		PUB	UNK		NA	HTN, hx polyps & stomach problems;arterial sclerosis;	NA~ ()~~~In patient	SC98083	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0981810~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0664E~2~SC~RA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~0908180~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0115508	12/10/1998	MA	80.0			U		some local inj site discomfort p/some aches & pains but primarily a congestive productive chest cold or infect;									Y		10/24/1998			OTH	UNK	nefdipine/adalat;	NONE	HTN;			1						2	Myalgia; Pain; Pharyngitis; Pyrexia; Rhinitis; Infection; Injection site pain; Myalgia; Pharyngitis	FLUX~UNKNOWN MANUFACTURER~~3~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0117253	12/10/1998	CA	7.0	7		F	12/08/1998	high fever 104.7;swollen red arm;abscess upper arm;				Y					Y	12/01/1998	12/02/1998	1		UNK	UNK						1						1	Abscess; Oedema peripheral; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U980530~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1542E~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0117255	12/10/1998	WV	27.0	27		F	11/21/1998	fatigue, confusion/disorientation, numbness on rt side of body/face shot administered in lt arm;				Y					Y	09/01/1998	09/19/1998	18		OTH	PUB			NA	~ ()~~~In patient		1						1	Asthenia; Confusional state; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0117262	12/10/1998	TX	78.0	78		M	12/04/1998	tickling in throat, dry cough, clear nasal, discharge, normal temps tri-care nurse advised using Dm tussin cough med;little phlegm coughed up & head congestion upon arising in Am;									Y	11/03/1998	11/05/1998	2		MIL	OTH	Atenolol, allopurinol, naproxin, prilosec	NONE	NONE	NONE~ ()~~~In patient		1						1	Cough; Pharyngitis; Rhinitis; Salivary hypersecretion	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0117264	12/10/1998	WI	60.0	60		F	12/07/1998	local site inflammation;									Y	12/03/1998	12/03/1998	0	NONE	PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Injection site inflammation	FLU3~PARKDALE PHARMACEUTICALS~0984540~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~12474~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0117280	12/11/1998	WA	44.0	44		M	11/03/1998	1 days p/vax pt devel achy joints & muscle, red macular rash began w/in hr of onset of achiness;seen by MD on day #7 post vax;pt had dime sized red macular rash over trunk & legs w/less involvement of arms;				Y					Y	10/27/1998	10/28/1998	1		PUB	PUB	NONE		NONE	~ ()~~~In patient	WA981509	1						1	Arthralgia; Myalgia; Rash maculo-papular	FLU3~PFIZER\WYETH~4988200~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0117281	12/11/1998	WA	2.0	2	.8	F		pt recv vax &  felt dizzy;BP 180/86;advised to MD;				Y					Y	10/06/1998	10/06/1998	0		OTH	UNK		NONE	allergy sulfa	~ ()~~~In patient	WA981510	1						1	Dizziness; Hypertension	FLU3~PFIZER\WYETH~4988200~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0117282	12/11/1998	WA	44.0	44		F	11/18/1998	pt recv vax & c/o scratchy throat & flushed face;BP 148/96;red, flushed face;BP 138/82;				Y					Y	11/16/1998	11/16/1998	0	NA	OTH	OTH	Thyroid & allegra PRN	NONE	ampicillin/PCN;indocin;iodine	~ ()~~~In patient	WA981515	1						1	Hypertension; Pharyngitis; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02298P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0117283	12/11/1998	WA	40.0	39		F	11/09/1998	approx 36hr p/vax;pt devel lt arm weakness-numbness extending down to hand;profound lymphadenopathy noted along lt clavicle region;				Y					Y	10/27/1998	10/27/1998	0		PUB	UNK			hx rock mountain spotted fever one month prior to immun	~ ()~~~In patient	WA981512	1						1	Lymphadenopathy; Myasthenic syndrome; Paraesthesia	FLU3~PARKDALE PHARMACEUTICALS~02298P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0117288	12/11/1998	OR	48.0	48		F		w/in 1hr of inj swelling began @ site;6hr later softball site rxn @ site;the following day involvement of arm to elbow up in shoulder;warm to touch;PMD gave prescription for DPH & DTC;				Y					Y	10/14/1998	11/14/1998	31	NONE	PUB	PVT		fibormyalgia	fibromyalgia	~ ()~~~In patient	OR9828	1						1	Injection site mass; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0971890~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~870H~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0117290	12/11/1998	MA	62.0	62		M	12/01/1998	lt arm became red swollen & painful w/in 24hr & pt had fever sl cough & other resp sx;sx lasted 14 days;pt was seen by a MD in the ER;				Y					Y	11/10/1998	11/11/1998	1		PUB	PUB	unk	NONE	unk	~ ()~~~In patient	MA9848	1						1	Cough; Oedema; Pain; Pyrexia; Respiratory disorder; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1389E~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0117297	12/11/1998	WA	50.0	50		M	10/17/1998	pt c/o heat sensation in lt pectoral muscle & lt arm felt very heavy (5min p/shot) for 20-25min a/releasing pt;									Y	10/17/1998	10/17/1998	0		OTH	PVT				~ ()~~~In patient	WA981503	1						1	Asthenia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0968380~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117299	12/11/1998	WA	38.0	38		F	10/23/1998	3hr p/vax devel low grade fever 99.2-99.5, productive cough, post nasal drip;all sx resolved 24hr later;									Y	10/20/1998	10/20/1998	0	NONE	PVT	UNK	NONE	NONE	NONE	~ ()~~~In patient	WA981513	1						1	Cough; Pyrexia; Rhinitis	FLU3~PFIZER\WYETH~4988203~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0117300	12/11/1998	WA	47.0	47		F	11/16/1998	pt recv vax 12NOV98 2PM & 8PM had onset of sore lt arm, felt like had a fever, generalized myalgia;fever lasted through 15NOV98 afternoon as well as myalgia;sore swollen arm a little better 16NOV98;									Y	11/12/1998	11/12/1998	0		PUB	PUB		NONE	NONE	~ ()~~~In patient	WA981514	1						1	Injection site oedema; Injection site pain; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0983330~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~LEDERLE LABORATORIES~453118~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0117301	12/11/1998	KY	63.0	63		U		arthralgia-cont to this date;weakness lt leg;									N	11/04/1998	11/09/1998	5	CBC & sed rate	PVT	OTH	NONE	NONE	reaction to rabies vax-anaphylaxis	pt exp anaphylaxis w/rabies vaccine~ ()~~~In patient		1						1	Arthralgia	FLU3~CONNAUGHT LABORATORIES~0983310~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117307	12/11/1998	CA	64.0	64		M	12/01/1998	redness near site of inj, swelling used cold compact to relieve the rash;the same day of inj started to exp cold & flu-like sx;sl fever, h/a, sore throat, coughing;sx lasted for 8wk;									Y	10/01/1998	10/01/1998	0	NONE	OTH	PVT	NONE	NONE	allergic to PCN, have hepatitis C	NONE~ ()~~~In patient		1						1	Cough; Headache; Influenza; Injection site hypersensitivity; Oedema; Pharyngitis; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0117313	12/14/1998	MO	54.0	54		M	12/08/1998	pt was adm to hosp 27NOV98 w/a dx of GBS;paralysis from the waist down;				Y	Y				N	10/30/1998	11/27/1998	28		OTH	PVT				~ ()~~~In patient		1						1	Guillain-Barre syndrome; Paralysis; Guillain-Barre syndrome; Paralysis	FLU3~CONNAUGHT LABORATORIES~0965840~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0965840~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0117316	12/14/1998	MO	45.0	45		F	11/04/1998	Pt recv vax on 10/30/98; 10 min post vax pt exp LA swelling (knot)/ sore/ bruising; rash on neck w/itching; tx=cold compress, Prednisone, Atarax				Y					Y	10/30/1998	10/30/1998	0	BP 130/82	PUB	PUB	Armour	UNK	Codeine & Penicillin allergy	UNK~ ()~~~In patient	AR9874	1						1	Ecchymosis; Hypersensitivity; Hypertension; Injection site hypersensitivity; Injection site oedema; Pain; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~0984540~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117317	12/14/1998	SC	70.0	70		F	10/30/1998	pt recv vax 23OCT98 about 230PM;around 930PM started itching & took DPH;awoke around 130Am w/high fever;went to ER w/T106 given ATB & told had rxn to pneumonia vaccine;c/o fever & body ache;myalgia;rt arm pain;T100;BP 130/73;				Y						10/23/1998	10/23/1998	0	urinalysis is unremarkable;CBC, SMA7 unremarkable;	PUB	UNK	Motrin & DPH;E-Vista;		breast cancer;has had chemotherapy;	~ ()~~~In patient	SC98076	1						1	Hypertension; Myalgia; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0981810~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~10944~1~SC~RA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~0963390~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0117325	12/14/1998	MT	24.0	24		F	11/20/1998	bells type palsy noted on lt side of face;devel w/in 12-18hr p/vax;DPH given w/no effect;MD currently tx w/pred;				Y					N	10/30/1998	10/31/1998	1		PVT	PUB	NONE	NONE	NONE	~ ()~~~In patient	MT98031	1						1	Facial palsy	FLU3~CONNAUGHT LABORATORIES~0977210~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0871H~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0117326	12/14/1998	MT	73.0	73		M	11/20/1998	rt eye watering, partial paralysis of face nerve rt side w/ptosis;rt corner of mouth not totally paralyzed;pred given;				Y					N	10/16/1998	11/03/1998	18		PVT	UNK	Lanoxin;Verapamil;ASA;	cold sore	nONE	~ ()~~~In patient	MT98032	1						1	Eyelid ptosis; Facial palsy; Lacrimal disorder	FLU3~PFIZER\WYETH~4988210~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0871H~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0117327	12/14/1998	AR	32.0	32		M	11/06/1998	pt states approx 4hr p/vax devel swelling of lips progressed 1hr later to devel hives-chest/abd/legs;no change overnight;saw PMD dx allerg eggs;				Y					Y	10/30/1998	10/30/1998	0		PUB	UNK		NONE ( recovered from flu vax 1wk prior)	NONE	~ ()~~~In patient	AR9871	1						1	Face oedema; Hypersensitivity; Urticaria	FLU3~CONNAUGHT LABORATORIES~0984540~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117328	12/14/1998	AR	48.0	48		F	10/26/1998	approx 5hr p/vax pt presented to nurses office @ school c/o weakness/wheezing/lightness in chest/diff breathing/hoarseness;went to PMD;racing pulse;rx decadron/clariton;				Y					Y	10/22/1998	10/22/1998	0	NONE	PUB	PUB	Estrolase	NONE	beef-milk	~ ()~~~In patient	AR9872	1						1	Asthenia; Asthma; Chest pain; Dysphonia; Dyspnoea	FLU3~CONNAUGHT LABORATORIES~0984540~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117333	12/14/1998	MI	81.0	81		M	11/17/1998	17NOV98 & c/o local rxn on rt arm from pneumonia vax given 16NOV98;inner aspect of rt upper arm approx 2 wide by 5 high w/fluid;some redness extend to backside of arm but all this was below the inj site;c/o itching;edema;				Y						11/16/1998	11/16/1998	0		PUB	PUB	Cardizem;ASA daily	NONE	neomycin;PCN	~ ()~~~In patient	MI98140	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4985203~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1542E~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0117336	12/14/1998	IL	45.0	45		M	12/09/1998	approx 730PM 11NOV98 recv vax & c/o pain, dec ROM, erythema, firm & tender to touch, pain & tenderness;became so severe by 630AM 11NOV saw MD;MD called local reaction to pneumovax;				Y					Y	11/10/1998	11/10/1998	0	NONE	PUB	PUB	unk	NONE	NONE	~ ()~~~In patient	IL98094	1						1	Hypokinesia; Pain; Rash; Skin nodule	FLU3~MEDEVA PHARMA, LTD.~E20168HB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~453070~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0117341	12/14/1998	NY	56.0	56		F	12/10/1998	hives;									Y	10/23/1998	10/26/1998	3	NONE	PVT	PVT				NA~ ()~~~In patient		1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~5301410010~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0117342	12/14/1998	NY	54.0	54		F	12/10/1998	w/in the first hr p/vax pt tongue swelled making it difficult for pt to speak or swallow;w/in a short time this went away (in the next hr or two)-no medication given;									Y	10/23/1998	10/23/1998	0		PVT	PVT				NA~ ()~~~In patient		1						1	Dysphagia; Speech disorder; Tongue oedema	FLUX~UNKNOWN MANUFACTURER~5301410010~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0117345	12/14/1998	MT	43.0	42		F	11/20/1998	hardened softball size reddened area (hot) itchy/sore/hard @ site of inj;still obvious sore;									Y	10/19/1998	10/21/1998	2		PUB	PVT	NONE	recovering sinusitis	NA	pt exp allergic type response w/PPD 1996-daughter exp same rxn w/daughter;~ ()~~~In patient	MT98029	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Pruritus	FLU3~PARKDALE PHARMACEUTICALS~02298P~2~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0117346	12/14/1998	MT	37.0	37		F	11/20/1998	warm, reddened, hardened area-cellulitis appearance;softball size still sore on 20NOV98;									Y	10/18/1998	10/19/1998	1	NONE	PVT	PVT	thyroid	NONE	NONE	NONE~ ()~~~In patient	MT98028	1						1	Cellulitis; Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02298P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0117348	12/14/1998	WV	40.0	40		F	11/30/1998	pt had localized pain, erythema & edema which started a day or so afterward @ inj site;now has lesion approx 1.5cm rt upper arm;lesion now resemble tinea in appearance;rt upper arm cont to be intermittently painful but pt has full use;									Y	11/13/1998	11/14/1998	1	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	WV9819	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0978670~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117361	12/14/1998	IL	79.0	78		M	11/02/1998	pt recv vax & was out of it per wife;									Y	10/30/1998	10/31/1998	1	NA	PUB	UNK		parkinson's disease	parkinson's disease;pt has brain injury d/t 02 deprivation during cardiac arrest;	NA~ ()~~~In patient	IL98088	1						1	Stupor	FLU3~MEDEVA PHARMA, LTD.~E201686A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0117364	12/14/1998	CT	53.0	53		F	11/06/1998	pain @ inj site 1hr p/vax that noc devel pain down arm to wrist & numbness in 2 small fingers;today no numbness but unusual feeling in fingers & sl pain @ inj site;										11/04/1998	11/04/1998	0		PUB	PUB		NONE	NKA			1						1	Injection site pain; Pain; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E201386B~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0116148	12/15/1998	MO	75.0	75		F		Pt recv vax on 10/21/98; 1 hr post vax pt exp painful/red/swollen/ hard arm, fever, ill feeling; tx=Dexamethasonel shot-2 & Cipro				Y					Y	10/21/1998	10/21/1998	0	UNK	OTH	OTH	Ogen, Nadolol, Norvasc, Chromagen	NONE	Scoliosis; Osteoporosis; Hypertension	UNK~ ()~~~In patient		1						2	Malaise; Oedema peripheral; Pain; Rash; Skin nodule; Vasodilatation; Malaise; Oedema peripheral; Pain; Skin nodule; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1246H~UNK~~RA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~1246H~UNK~~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0117374	12/15/1998	MA	44.0	44		F	12/09/1998	GBS; Annual follow-up dated 2/15/01 provided no additional data.					Y					10/26/1998	11/30/1998	35		OTH	PUB						1						1	Guillain-Barre syndrome; CSF test abnormal; Myasthenic syndrome; Red blood cell sedimentation rate increased	FLU3~CONNAUGHT LABORATORIES~0975780~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0975780~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0117375	12/15/1998	MA	48.0	48		M	12/09/1998	GBS;pt admitted to hosp;Annual follow-up dated 09/28/00 states the pt is 80% recovered.					Y				U	10/15/1998	11/25/1998	41		PVT	OTH	Multiple vitamins	progressive weakness	NONE, healthy			1						1	Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~0983380~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0117378	12/15/1998	ID	36.0	36		M	12/07/1998	chills, severe shaking, high temp 104, lasting approx 1 1/2hr, body aches, sweating profusely by 3AM recovered;problem breathing, some coughing;			Y						Y	11/24/1998	11/24/1998	0	NONE	PUB	PVT	NONE	sniffles	jellyfish allergy	~ ()~~~In patient		1						1	Cough; Dyspnoea; Hyperhidrosis; Myalgia; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0117384	12/15/1998	CO	8.0	8		M	12/11/1998	Pt recv vax on 11/20/98; on 12/1/98 pt exp parotitis of LA &RA; tx=antibiotics				Y					Y	11/20/1998	12/01/1998	11	NONE	PVT	PVT	UNK	Cough	Mild reactive airway	UNK~ ()~~~In patient		1						1	Sialoadenitis	FLU3~CONNAUGHT LABORATORIES~0983330~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1359H~2~SC~~MEASLES + MUMPS + RUBELLA (MMR I)~1	USA	Emergency room visit	Influenza
0117386	12/15/1998	OH	56.0	56		F	11/10/1998	Pt recv vax on 10/9/98; 25 min post vax pt exp dizziness, lightheaded, tingling in mouth, face& right hand, swollen tongue; pt to E.R.; tx=Prednisone &Benadryl				Y					Y	10/09/1998	10/09/1998	0	Lab tests	OTH	PVT	Allergy shot, Propulsid, Premarin, Welbutrin, Rhiocort, Allegra, Migrinal	NONE	Allergic to Compazine, Conhist, Penicillin, Elavil, Biaxin; Migraines	NONE~ ()~~~In patient		1						1	Dizziness; Paraesthesia; Paraesthesia oral	FLU3~CONNAUGHT LABORATORIES~0975840~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117388	12/15/1998	WA	26.0	26		F	11/12/1998	Pt recv vax on 10/15/98; on 10/18/98 pt exp LA weakness/numb/ tingling				Y					U	10/15/1998	10/18/1998	3	NONE	PVT	PUB	UNK	NONE	NONE	UNK~ ()~~~In patient		1						1	Myasthenic syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0981790~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117392	12/15/1998	IA	25.0	25		F	11/22/1998	Pt recv vax on 10/26/98; 1 hr post vax pt exp lump at vax site/ erythemic, warm area/ sore x 1 wk									Y	10/26/1998	10/26/1998	0	NONE	PVT	PVT	NONE	NONE	Allergic to latex & bee stings			1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0978720~1~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117394	12/15/1998	IN	72.0	72		F	12/07/1998	Pt recv vax on 11/20/98; on 11/22/98 pt exp nausea, cramping & RA bruised									Y	11/20/1998	11/22/1998	2	NONE	PVT	PVT	UNK	Hypertension	Hypothyroidism	UNK~ ()~~~In patient		1						1	Abdominal pain; Ecchymosis; Injection site hypersensitivity; Nausea	FLU3~CONNAUGHT LABORATORIES~0965770~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117396	12/15/1998	IA	40.0	40		F	12/07/1998	Pt recv vax on 10/27/98; on 10/28/98 pt exp pain/swelling/ red/ hot of vax arm, headache, nausea, chills, fever (101), vomitting, aches									Y	10/27/1998	10/28/1998	1	NONE	PUB	PVT	Cardizem	NONE	Allergic to aspirin & Demerol; High blood pressure			1						1	Headache; Injection site hypersensitivity; Injection site oedema; Myalgia; Nausea; Pain; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~0971060~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117400	12/15/1998	NY	15.0	15		M	12/15/1998	Pt recv vax on 10/25/98; within 24 hr pt exp paleness, discolored rash of LA									N	10/25/1998	10/25/1998	0	NONE	PVT	OTH	HepB/Recomb.-RA	NONE	Allergic to Augmentin, Doxycycline, environment	NONE~ ()~~~In patient		1						1	Dermatitis exfoliative; Pallor; Rash maculo-papular; Skin discolouration	FLU3~PFIZER\WYETH~4988203~3~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0117403	12/15/1998	IN	66.0	66		M	12/07/1998	Pt recv vax on 12/1/98; on 12/3/98 pt exp additional use of inhaler for asthma/breathing, itchy rash over body, achey wrists, swollen lips									Y	12/01/1998	12/03/1998	2	NONE	PUB	PVT	Albutorol inhaler	NONE	Asthma	UNK~ ()~~~In patient		1						1	Arthralgia; Asthma; Condition aggravated; Dyspnoea; Face oedema; Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0117406	12/15/1998	MN	45.0	45		F	12/04/1998	Pt recv vax on 11/30/98; on 12/1/98 pt exp sore RA, fever (100.9), joints aching, nausea									N	11/30/1998	12/01/1998	1	NONE	PVT	OTH	Vitamin C, Calcium, Prednisone, Folic Acid, Premarin, Tylenol, Methaltrexate	Lupus	Lupus,  Allergic to Penicillin, Sulfa, Codeine	UNK~ ()~~~In patient		1						1	Arthralgia; Bronchitis; Dyspepsia; Lymphadenopathy; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0117313	12/16/1998	MO	54.0	54		M	12/14/1998	pt recv vax 30OCT98 & pt was admitted to hosp 27NOV98 w/dx of GBS;paralysis from the waist down;				Y	Y				U	10/30/1998	11/27/1998	28		OTH	PVT				~ ()~~~In patient	U199800896	1						2	Guillain-Barre syndrome; Paralysis; Guillain-Barre syndrome; Paralysis	FLU3~CONNAUGHT LABORATORIES~0965840~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0965840~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0117417	12/16/1998	IL	62.0	62		M	10/08/1998	Pt recv vax on 10/6/98; on 10/7/98 pt exp swelling & itching of LA w/ warmth, erythema									U	10/06/1998	10/07/1998	1	UNK	OTH	OTH	UNK	UNK	UNK	NONE~ ()~~~In patient		1						1	Oedema peripheral; Pruritus; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0117422	12/16/1998	AL	61.0	61		M	12/10/1998	Pt recv vax on 10/15/97; on 10/16/97 pt exp unable to hear (75% loss) in left ear/ nerve damage; tx=Prednisone; Annual follow-up dated 2/21/01 provided no additional data.				Y				Y	N	10/15/1997	10/16/1997	1	Pt referred to two other M.D.s (Hagood & Pappas)	MIL	OTH	UNK	NONE	NONE			1						1	Deafness permanent; Neuropathy	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0117426	12/16/1998	AL	27.0	27		M	11/16/1998	Pt recv vax on 11/5/98; on 11/10/98 pt exp macular, itchy rash of shoulders, face & extremeties; fever; achey joints; hands & feet swollen; tx=Prednisone & Zyrtec				Y					Y	11/05/1998	11/10/1998	5	WBC-17; ESR-34; Urinalysis-trace protein	OTH	PVT	NONE	NONE	Allergic to Penicillin-rash; Erythromycin-rash			1						1	Arthralgia; Laboratory test abnormal; Oedema peripheral; Pruritus; Pyrexia; Rash maculo-papular; Red blood cell sedimentation rate increased; Urine analysis abnormal	FLU3~CONNAUGHT LABORATORIES~0985890~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117429	12/16/1998	MN	40.0	40		M	12/11/1998	Pt recv vax on 10/26/98; on same day pt exp lightheaded, dizzy, near syncope; pt to E.R.				Y					Y	10/26/1998	10/26/1998	0	NONE	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Dizziness; Syncope	FLU3~PARKDALE PHARMACEUTICALS~02788P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0117432	12/16/1998	FL	27.0	27		F	12/11/1998	Pt recv vax on 10/16/98; 7 min post vax pt exp shakiness, nausea, hyperventilating, red face, anxiety									Y	10/16/1998	10/16/1998	0	UNK	OTH	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Anxiety; Hyperventilation; Nausea; Tremor; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0983320~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117433	12/16/1998	FL	79.0	79		F	12/10/1998	Pt recv vax on 10/5/98; on same day pt exp chills & sweating									U	10/05/1998	10/05/1998	0	UNK	OTH	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Chills; Hyperhidrosis	FLU3~CONNAUGHT LABORATORIES~0981790~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117434	12/16/1998	FL	77.0	77		F	12/10/1998	Pt recv vax on 10/6/98; on 10/7/98 pt exp runny nose, chills & shaking									U	10/06/1998	10/07/1998	1	UNK	OTH	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Chills; Rhinitis; Tremor	FLU3~CONNAUGHT LABORATORIES~0980580~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117435	12/16/1998	FL	73.0			F	12/10/1998	Pt recv vax on unknown day; post vax pt exp chills, fever, up all night, sluggish									U				UNK	OTH	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Insomnia; Pyrexia; Somnolence	FLU3~CONNAUGHT LABORATORIES~0981820~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117436	12/16/1998	FL	64.0	64		F	12/10/1998	Pt recv vax on 10/9/98; 1 hr post vax pt exp blood under skin/ purple/ sore/ hot x 3 day									U	10/09/1998	10/09/1998	0	UNK	OTH	OTH	UNK	UNK	UNK			1						1	Ecchymosis; Haemorrhage; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0981820~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117437	12/16/1998	FL	17.0	17		F	12/10/1998	Pt recv vax on 10/9/98; 1 hr post vax pt exp congestion, achy, chills, fever, flu-like sx, mono, tonsillitis									U	10/09/1998	10/09/1998	0	UNK	OTH	OTH	UNK	UNK	UNK			1						1	Influenza; Lymphocytosis; Myalgia; Pharyngitis; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0981820~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117438	12/16/1998	FL	54.0	54		F	12/10/1998	Pt recv vax on 10/10/98; 12 hr post vax pt exp fever, chills, hot & cold flu sx, stomach pains									U	10/10/1998	10/10/1998	0	UNK	OTH	OTH	UNK	UNK	UNK			1						1	Abdominal pain; Influenza; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0981820~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117439	12/16/1998	FL	92.0	92		F	12/10/1998	Pt recv vax on 10/13/98; on 10/15/98 pt exp red/ hot/ swollen vax site									U	10/13/1998	10/15/1998	2	UNK	OTH	OTH	UNK	UNK	UNK			1						1	Oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0981820~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117440	12/16/1998	FL	84.0	84		M	12/10/1998	Pt recv vax on 10/13/98; on 10/14/98 pt exp lump on left jaw									U	10/13/1998	10/14/1998	1	UNK	OTH	OTH	UNK	UNK	UNK			1						1	Lymphadenopathy	FLU3~CONNAUGHT LABORATORIES~0981820~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117441	12/16/1998	FL	78.0	78		F	12/10/1998	chills, fever, ache, loss of breath;									U	10/13/1998	10/16/1998	3		UNK	UNK						1						1	Dyspnoea; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0981820~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117442	12/16/1998	FL	68.0	68		F	12/10/1998	sl itching;small red lump;									U	10/14/1998	10/15/1998	1		UNK	UNK						1						1	Pruritus; Skin nodule; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0981820~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117443	12/16/1998	FL	67.0	67		F	12/10/1998	chills, fever, hot, achy										10/15/1998	10/15/1998	0		UNK	UNK				~ ()~~~In patient		1						1	Myalgia; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0981820~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117444	12/16/1998	FL	64.0	63		F	12/10/1998	red spot bigger than silver dollar;hard & hot;									Y	10/15/1998	10/16/1998	1		UNK	UNK				~ ()~~~In patient		1						1	Skin nodule; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0981820~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117445	12/16/1998	FL	67.0	66		M	12/10/1998	fever, chills, pain, achy all over lasted 1 day;										10/16/1998				UNK	UNK				~ ()~~~In patient		1						1	Pain; Pruritus; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0981820~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117446	12/16/1998	FL	24.0	24		F	12/11/1998	sore, tender, burning sensation in back of arm;										10/19/1998	10/19/1998	0		UNK	UNK				~ ()~~~In patient		1						1	Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~0984530~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117447	12/16/1998	FL	72.0	72		F	12/11/1998	arm swollen;hot;very sore;temp 102;										10/20/1998	11/20/1998	31		UNK	UNK				~ ()~~~In patient		1						1	Myalgia; Oedema peripheral; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0983320~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117448	12/16/1998	FL	68.0	68		F	12/11/1998	lightheaded, dizziness, no local reaction;										10/24/1998	10/24/1998	0		UNK	UNK				~ ()~~~In patient		1						1	Dizziness	FLU3~CONNAUGHT LABORATORIES~0981820~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117450	12/16/1998	FL	72.0	71		M	12/11/1998	chills, fever, cough, sore throat;										10/22/1998	10/24/1998	2		UNK	UNK				~ ()~~~In patient		1						1	Cough; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0981820~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117451	12/16/1998	FL	49.0	49		F	12/11/1998	cough, sore throat;										10/27/1998				UNK	UNK				~ ()~~~In patient		1						1	Cough; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~0981820~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117452	12/16/1998	FL	53.0	53		F	12/11/1998	site black/blue rt arm hot, red bump;										10/29/1998	10/30/1998	1		UNK	UNK				~ ()~~~In patient		1						1	Ecchymosis; Injection site hypersensitivity; Skin nodule; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0984530~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117453	12/16/1998	FL	68.0	68		M	12/11/1998	Pt recv vax on 11/5/98; on 11/6/98 pt exp a cold									U	11/05/1998	11/06/1998	1	UNK	OTH	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0983320~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117454	12/16/1998	FL	37.0	37		F	12/11/1998	Pt recv vax on 11/10/98; on 11/11/98 pt exp rash all over & swollen joints									U	11/10/1998	11/11/1998	1	UNK	UNK	UNK	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Osteoarthritis; Rash	FLU3~CONNAUGHT LABORATORIES~0984530~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117455	12/16/1998	FL	67.0	67		M	12/11/1998	Pt recv vax on 11/11/98; on 11/12/98 pt exp sore throat, drainage, cough & sweats									U	11/11/1998	11/12/1998	1	UNK	OTH	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Cough; Hyperhidrosis; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0984530~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117456	12/16/1998	FL	62.0	62		M	12/11/1998	Pt recv vax on 11/12/98; on 11/16/98 pt exp fever (103), achy, chills, dry cough									U	11/12/1998	11/16/1998	4	UNK	OTH	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Chills; Cough; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0983320~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117457	12/16/1998	FL	40.0	40		F	12/11/1998	Pt recv vax on 11/12/98; post vax pt exp achy, nausea, chills, sweats & fever									U	11/12/1998	11/12/1998	0	UNK	OTH	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Chills; Hyperhidrosis; Myalgia; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0983320~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117458	12/16/1998	FL	87.0	87		F	12/11/1998	Pt recv vax on 10/26/98; post vax pt missed chair-fell & fx hip									U	10/26/1998			UNK	OTH	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Coordination abnormal; Injury	FLU3~CONNAUGHT LABORATORIES~0981820~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117463	12/16/1998	CA	38.0	38		F	10/20/1998	Pt recv vax on 10/16/98; on 10/17/98 pt exp fever (99.4), malaise									U	10/16/1998	10/17/1998	1	UNK	PVT	PVT	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Malaise; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0117449	12/17/1998	FL	67.0	67		F	12/11/1998	achy, chills;										10/21/1998	10/24/1998	3		UNK	UNK				~ ()~~~In patient		1						1	Chills; Myalgia	FLU3~CONNAUGHT LABORATORIES~0981820~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117472	12/17/1998	AZ	29.0	29		F	12/04/1998	acute allergic rxn (beginning 19NOV through 23NOV) breathing problems cont currently hives over entire body, swelling of air passages, & tongue;general malaise, dehydration, pain in kidneys;				Y					N	11/19/1998	11/19/1998	0		OTH	OTH	NONE	NONE	strawberry, pollen allergies;no egg or feather allergies;	NONE~ ()~~~In patient	FLU91111298	1						1	Dehydration; Dysphagia; Dyspnoea; Hypersensitivity; Laryngeal oedema; Malaise; Pharyngitis; Pulmonary oedema; Renal pain; Rhinitis; Tongue oedema; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~03088P~1~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0117473	12/17/1998	PA	58.0	58		M	11/24/1998	pain rt arm, rt thigh & both pretibial area;persisted for greater than 1wk;					Y	4			Y	11/12/1998	11/20/1998	8	protime 44 sec (INR 12), CPK 600 w/NCL 20, sed rate 104;	PVT	OTH	Insulin, ASa, VITE, lipitor, KCL, lisinopril, synthroid, digoxin, flumax, indur, lasix, norvasc	CAD, IDM, renal insuff	NONE	NONE~ ()~~~In patient	FLU91081298	1						1	Arthralgia; Pain	FLU3~PARKDALE PHARMACEUTICALS~00408P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0117477	12/17/1998	UT	32.0	32		F	10/23/1998	Pt recv vax on 10/23/98; 15 min post vax pt exp red vax site; weird feeling all over; warm & chills; tight chest; shaking				Y					Y	10/23/1998	10/23/1998	0	Blood pressure-120/76; Pulse 80, Resp 30, Temp 98	PUB	OTH	Flovent, Survent, Claritan, Albuterol, Asthmacort	Asthma-not active	Allergy to ragweed, pollen, grass; Hx of anorexia/bullemia: 1 meal daily; asthma	NONE~ ()~~~In patient		1						1	Chest pain; Hyperventilation; Hypothermia; Injection site hypersensitivity; Malaise; Pyrexia; Tremor	FLU3~CONNAUGHT LABORATORIES~0978740~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117478	12/17/1998	UT	36.0	36		F	11/05/1998	Pt recv vax on 11/5/98; 10 min post vax pt exp numb arm, difficulty breathing, fever (100), high blood pressure, hyperventilating; tx=Choramine, supine position, Epinephrine				Y						11/05/1998	11/05/1998	0	Blood pressure-130/60, 180/100, 160/70	OTH	PVT	UNK	UNK	Allergic to Sulfa drugs			1						1	Dyspnoea; Hypertension; Paraesthesia	FLU3~PARKDALE PHARMACEUTICALS~01698P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0117479	12/17/1998	MO	8.0	8		M	12/07/1998	Pt recv vax on 12/4/98; on 12/5/98 pt exp fever, eyes swollen shut w/ black lines under eyes; tx=Benadryl & Delgasone				Y					Y	12/04/1998	12/05/1998	1	NONE	PUB	PUB	NONE	NONE	NONE		MO98079	1						1	Face oedema; Pyrexia; Skin discolouration	FLU3~PFIZER\WYETH~4988337~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0117480	12/17/1998	MO	75.0	75		F	11/12/1998	Pt recv vax on 10/12/98; on same day pt exp pain in LA; difficulty w/ pronation of left hand & picking up objects				Y					U	10/12/1998	10/12/1998	0	NONE	PUB	PUB	Pt unsure of names	NONE	Respiratory-chronic; Hx of back surgery resulting in chronic muscle spasms; Hx of bladder surgery	NONE~ ()~~~In patient	MO98081	1						1	Coordination abnormal; Hypokinesia; Pain	FLU3~CONNAUGHT LABORATORIES~0983310~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~0967100~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0117481	12/17/1998	MO	28.0	28		F	11/20/1998	Pt recv vax on 11/16/98; on same day pt exp red/ hot/ itchy/ hives at vax site; tx=Benadryl									Y	11/16/1998	11/16/1998	0	NONE	PUB	PUB	Orthotricycin, Synthroid	NONE	Allergic to Sulfa, Penicillin, Macrobid; Hypothyroidism	NONE~ ()~~~In patient	MO98084	1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0983310~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117483	12/17/1998	MO	50.0	50		F	11/16/1998	Pt recv vax on 11/13/98; 10 min post vax pt exp nausea, dizzy, lightheaded, Rt Arm swollen, achy, high blood pressure									Y	11/13/1998	11/13/1998	0	Blood pressure 180/115, 175/80	PUB	PUB	Lotensi-stomach med	NONE	Allergic to IVP dye	UNK~ ()~~~In patient	MO98082	1						1	Dizziness; Hypertension; Injection site oedema; Myalgia; Nausea	FLU3~CONNAUGHT LABORATORIES~0983310~1~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117484	12/17/1998	MO	31.0	31		F	11/16/1998	Pt recv vax on 11/12/98; on same day pt exp right thumb swelling/ red/ hot/ pain; tx=ice applied									Y	11/12/1998	11/12/1998	0	NONE	PUB	PVT	Birth control	NONE	NONE	NONE~ ()~~~In patient	MO98080	1						1	Oedema peripheral; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0983310~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117486	12/17/1998	OH	56.0	56		F	10/26/1998	Pt recv vax on 10/23/98; on same day pt exp red/ edema/ warmth/ raised area of LA, fever; tx=Camexin, Motrin									Y	10/23/1998	10/23/1998	0	Watching for signs of infection	UNK	UNK	Premarin, Synthroid	NONE	Allergic to Penicillin	UNK~ ()~~0.00~In Patient	OH98109	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4988204~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~454379~1~SC~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0117489	12/17/1998	AL	43.0	43		M	07/07/1998	Pt recv vax in 11/97; on 12/12/97 pt exp HTLV-2 positive; in 2/98 pt exp HTLV-2 negative				Y					Y	11/01/1997	12/12/1997	41	12/12/98 Elisa HTLV-2: postive; 2/98 Elisa HTLV-2: negative	MIL	MIL	UNK	NONE	UNK	UNK~ ()~~~In patient	898191091A	1						1	Laboratory test abnormal	FLU3~PFIZER\WYETH~~UNK~SC~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0117490	12/17/1998	UT	73.0			U	07/29/1998	Pt recv vax on unknown day; 2 - 3 wk post vax pt exp rash on chest & back (red bumps); tx=iodine applications									Y				UNK	OTH	OTH	UNK	UNK	Hx of similar rash in Fall '96 on chest & back	UNK~ ()~~~In patient	898216073A	1						1	Rash maculo-papular	FLU3~PFIZER\WYETH~4978202~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0117491	12/17/1998	CT				F	09/22/1998	Pt recv vax on unknown day; post vax pt exp vax site rx of redness & swelling; 1 wk post vax pt exp flu;tx=Benadryl									Y				UNK	OTH	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient	898266053A	1						1	Influenza; Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0117492	12/17/1998	OH				F	02/09/1998	Pt recv vax on 11/3/97; on 11/04/97 pt exp vax site rx of redness & pain									Y	11/03/1997	11/04/1997	1	UNK	OTH	OTH	UNK	NONE	UNK	UNK~ ()~~~In patient	898279002L	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4978296~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0117495	12/18/1998	FL	59.0	59		F	12/16/1998	pt hosp 6DEC98;discharged 12DEC98;				Y	Y	7			N	12/01/1998	12/03/1998	2		PVT	PVT		emphysema, asthma, COPD	sulfa, penicillin	~ ()~~~In patient		1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0117504	12/18/1998	PA	54.0	54		F	12/10/1998	Pt recv vax on 11/11/98; on 11/17/98 pt exp red, raised rash; tx=Benadryl, oatmeal baths				Y					Y	11/11/1998	11/17/1998	6	NONE	OTH	OTH	UNK	NONE	NONE	UNK~ ()~~~In patient		1						1	Rash maculo-papular	FLU3~PARKDALE PHARMACEUTICALS~00408P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0117505	12/18/1998	PA	36.0	36		F	12/10/1998	Pt recv vax on 11/20/98; 45 min post vax pt exp Rt Arm heavy & numb; pt imp 11/22/98				Y					Y	11/20/1998	11/20/1998	0	Negative neurologic assessment	OTH	OTH	UNK	NONE	NONE			1						1	Myasthenic syndrome; Paraesthesia	FLU3~PARKDALE PHARMACEUTICALS~00408P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0117509	12/18/1998	MD	65.0	65		F	12/15/1998	Pt recv vax on 10/22/98; on 10/23/98 pt exp chills, fever, upset stomach, sore arm									U	10/22/1998	10/23/1998	1	UNK	OTH	OTH	Temorin, Zyloprin	NONE	Chronic HA, degenerating cervical disc	UNK~ ()~~~In patient		1						1	Chills; Dyspepsia; Pain; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E20118GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0117511	12/18/1998	MS	37.0	36		F	12/18/1998	Pt recv vax on 12/15/98; on 12/18/98 pt exp numb LA  &neck, fever blister on lip									N	12/15/1998	12/18/1998	3	NONE	OTH	OTH	Buopar	NONE	Allergic to smoke, caffeine, chocolate, milk, pork	UNK~ ()~~~In patient		1						1	Mouth ulceration; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0117512	12/18/1998	PA	73.0	73		F	12/14/1998	Pt recv vax on 12/7/98; on 12/8/98 pt exp angiodema of tongue; tx=Zyrtec, Peparol									Y	12/07/1998	12/08/1998	1	UNK	PVT	OTH	Valotec, Calan, Asprin, Hydrochlorathiazide	NONE	Allergic to Codeine	UNK~ ()~~~In patient		1						1	Angioneurotic oedema	FLU3~CONNAUGHT LABORATORIES~0965780~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117516	12/18/1998	PA	59.0	59		M	12/14/1998	Pt recv vax on 11/9/98; on 11/11/98 pt exp fever (102) x 5 day; aches & pain, stiff neck, sore muscles, sore throat, cough, chills									Y	11/09/1998	11/11/1998	2	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Chills; Cough; Myalgia; Nuchal rigidity; Pain; Pharyngitis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0117517	12/18/1998	IN	33.0	33		F	12/04/1998	Pt recv vax on 11/1/98; on 11/2/98 pt exp pain, swelling, red hardening of vax site; swollen fingers &thumb;tx=Medrol									Y	11/01/1998	11/02/1998	1	UNK	PVT	PVT	NONE	NONE	Allergic to Sulfa, ASA; Hypoglycemia	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~0984570~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117521	12/18/1998	OH	45.0	45		M	11/18/1998	Pt recv vax on 11/16/98; 3 hr post vax pt exp nausea, dizzy, headache									Y	11/16/1998	11/16/1998	0	UNK	PVT	PVT	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Dizziness; Headache; Nausea	FLU3~CONNAUGHT LABORATORIES~0984580~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0116348	12/21/1998	VA	67.0	67		F		pt recv vax & exp day time diarrhea, weakness @ night;sick, very weak on arrival in PM;could not walk or bathe w/o assistance;arms & legs trembling;less mobile;poss GBS;pt stated needed glasses; Annual follow-up dated 2/15/01 states the pt was hospitalized with a severe ear infection in 2/99. Suffered complete loss of hearing in right ear. No recovery to date. the pt contracted Bell's Palsy while hospitalized with partial paralysis to the right side of face. Total recovered after 3 months.				Y	Y	4			N	10/19/1998	10/21/1998	2	blood sugar 181;elevated cholesterol 286;LDL 152;	PVT	PVT	Lopressor, Lopid, Baycol, allopurinol, ultram	NONE	herniated disk L4-L5;			1						2	Amblyopia; Asthenia; Diarrhoea; Enzyme abnormality; Hypokinesia; Myopathy; Vomiting; Asthenia; Diarrhoea; Hypercholesterolaemia; Hyperglycaemia; Hypokinesia; Myopathy; Tremor; Visual disturbance	FLU3~MEDEVA PHARMA, LTD.~E20188HC~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~E20188HC~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Hospitalisation	Influenza
0116914	12/21/1998	NJ	68.0	68		F	10/23/1998	devel fever 102 & chills 10OCT98 9PM;by 11OCT98 3PM fever gone, hives appeared on opposite arm;more or less 10yr ago exp similar rxn p/vax;									Y	10/09/1998	10/10/1998	1		UNK	UNK		NONE	NONE		NJ9834	1						2	Chills; Pyrexia; Urticaria; Chills; Pyrexia; Urticaria; Vaccine positive rechallenge	FLUX~UNKNOWN MANUFACTURER~0977180~UNK~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~0977180~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0117374	12/21/1998	MA	44.0	44		F	12/08/1998	elevated CSF protein, ascending weakness in lower limbs, re admitted on 9DEC98, intubated;					Y	1			Y	10/26/1998	12/03/1998	38	fur mono negative;lumbar spinal tap 4DEC98-cult showed no abnormalities;glucose nl;sed rate elevated;	PUB	PUB	unk	NONE	unk	~ ()~~~In patient	MA9851	1						2	Guillain-Barre syndrome; CSF test abnormal; Myasthenic syndrome; Red blood cell sedimentation rate increased	FLU3~CONNAUGHT LABORATORIES~0975780~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0975780~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0117527	12/21/1998	NY	61.0	61		F		pt exp diarrhea 24SEp;8hr later upset stomach;7hr later dyspnea;	Y	11/20/1998							N	09/11/1998	09/24/1998	13	BP 104/70;T97.9;pulse 96;resp 20;	PVT	PVT	Theodur;Pred;Xanas;Azmacort;Synthroid;Aldactone;Lasix;KDUR;albuterol;atrovent;loxanol;	no acute illness afeb;end state COPD;	End Stage COPD; corpulmonale;HTN;Heart Failure	~ ()~~~In patient		1						1	Apnoea; Cachexia; Condition aggravated; Diarrhoea; Dyspepsia; Dyspnoea; Hypotension; Hypothermia; Lung disorder; Tachycardia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0117528	12/21/1998	MD	35.0	35		M	12/15/1998	throbbing in upper arm couldn't remember which side immed p/vax;sharp pain in lt shoulder, progressive, weakness of mouth, tongue, lips over next several wk;adm to hosp 7DEC98 w/suspected GBS;					Y	13			Y	11/07/1998	11/07/1998	0	CSF protein 100; EMG abnormal	OTH	PVT	NONE	NONE	NONE			1						1	Facial palsy; Guillain-Barre syndrome; Hyporeflexia; Myasthenic syndrome; Pain; Paraesthesia; Paraesthesia oral	FLU3~PFIZER\WYETH~4988235~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~MERCK & CO. INC.~1555E~UNK~~~HEP B (RECOMBIVAX HB)~1	USA	Hospitalisation	Influenza
0117535	12/21/1998	ID	62.0	62		F		7OCT98 2PM fever, nauseated, lt arm hurt, swollen, T104, arm throbbed hot & cold packs 7 ASA taken;soup 10PM from elbow up lt arm bright red;T99 in Am swelling down;feels much better;									Y	10/07/1998	10/07/1998	0	NONE	PUB	PUB	smz/tmpds;bactrim	bronchitis last week;	hospitalized DEC97 & MAR98-pneumonia;	NONE~ ()~~~In patient	ID98046	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Nausea; Pyrexia	FLU3~PFIZER\WYETH~4988200~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~442522~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0117537	12/21/1998	ID	25.0	25		M	10/22/1998	pt stated that has a rash on arms, trunk & face;face felt hot;told to call MD;									U	10/20/1998	10/21/1998	1		PUB	PUB	Zovirax	NONE	NKA or medical conditions	~ ()~~~In patient	ID98049	1						1	Rash; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20238KB~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~SMITHKLINE BEECHAM~2707A6~2~IM~RA~HEP B (ENGERIX-B)~1	USA		Influenza
0117542	12/21/1998	ID	31.0	30		F	10/21/1998	21OCT98 took very hot shower today, @ the end of which felt lightheaded, dizzy & broke out in cold sweat;also noticed a hugh red spot on rt upper arm today;hard knot w/mild tenderness;									N	10/14/1998	10/21/1998	7	NONE	PUB	PUB	NONE				ID98057	1						1	Chills; Dizziness; Hyperhidrosis; Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~MEDEVA PHARMA, LTD.~E20238KB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~SMITHKLINE BEECHAM~2707A6~1~IM~RA~HEP B (ENGERIX-B)~1|HEPA~SMITHKLINE BEECHAM~564B6~1~IM~LA~HEP A (HAVRIX)~1|TD~LEDERLE LABORATORIES~454679~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1|TYP~BERNA BIOTECH, LTD.~0150891B~1~PO~MO~TYPHOID LIVE ORAL TY21A (VIVOTIF)~1	USA		Influenza
0117545	12/21/1998	MI	41.0	41		F	12/15/1998	brachial plexus neuropathy									N	10/27/1998	10/27/1998	0	EMG & neurology consult, chronic pain management consult;	PUB	UNK	Monopril;ASA	NONE	HTN	~ ()~~~In patient		1						1	Neuropathy	FLU3~PFIZER\WYETH~4988204~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0117548	12/21/1998	CT	2.0	2	.5	M		10cm diameter, indurated, tender, erythematous area lt tricep area x 7-9 days;									Y	10/07/1998	10/08/1998	1	NONE	PVT	UNK	Budesonide, rynatan;albuterol;bactrim	NONE	asthma	pt exp rxn @ 1 1/2 flu w/2nd dose;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~02988P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0117550	12/21/1998	NJ	28.0	28		F	11/24/1998	pt recv vax 4NOV98 3PM & exp chest tightness & difficulty breathing during the late evening hours of same day;sx disappeared by next AM but pt left feeling out of it;felt nl day 3;									Y	11/04/1998	11/04/1998	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	NJ9830	1						1	Chest pain; Dyspnoea; Malaise	FLU3~CONNAUGHT LABORATORIES~0975840~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117552	12/21/1998	NY	6.0	6		M	12/16/1998	T103.3;area of erythema & swelling below inj site rt arm = 5 1/2 x 5 1/2cm;									Y	12/14/1998	12/15/1998	1	NONE	PVT	PVT	NONE	lt otitis media	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0978660~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1452E~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0117562	12/21/1998	MA	73.0	73		F	12/09/1998	hives w/itch over all body;pt recv vax 28OCT98 530PM-hives Thursday took DPh-went to hosp Sunday;rx w/IV DPH & ATB;				Y					Y	10/28/1998	10/29/1998	1	unk	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MA9850	1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~0975780~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117564	12/21/1998	MI	78.0	78		F	12/04/1998	1 to 2 days p/vax pt began having pain in lt hip;2 days later pain transferred to rt leg & currently rt leg cont to be painful, cannot sleep or do physical activity;dx sciatica;taking strong pain pills & muscle relaxants;				Y					N	10/15/1998	10/17/1998	2	NONE	PUB	PVT	Synthroid;Catapress;Diavan	NONE	low thyroid;high blood pressure	NA~ ()~~~In patient	MI98143	1						1	Arthralgia; Back pain; Hypertonia; Hypokinesia; Insomnia; Myalgia; Pain	FLU3~MEDEVA PHARMA, LTD.~E20188HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0117565	12/21/1998	MI	76.0	76		M	12/04/1998	1-2 days p/vax began having a sore back (lower);pain progressed to the lt leg & has remained;pain is severe, unable to sleep/walk or do any physical activity comfortable;				Y					N	10/15/1998	10/17/1998	2	MRI was done;no nerve damage showing related to the sx;	PUB	PUB	Tenormen;Triant;Zocor;Norvasc;Hytrin;Baby aspirin	NONE	heart condition has pacemaker;high cholesterol	NA~ ()~~~In patient	MI98144	1						1	Back pain; Hypokinesia; Insomnia; Pain	FLU3~MEDEVA PHARMA, LTD.~E20188HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0117568	12/21/1998	CO	75.0	74		F	12/16/1998	large black bruise devel a sore muscle that didn't go away;MD ordered anti-inflammatory med & hot packs;				Y					Y	10/15/1998	10/16/1998	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	CO98061	1						1	Ecchymosis; Myalgia	FLU3~MEDEVA PHARMA, LTD.~E20218HC~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0117569	12/21/1998	CO	55.0	55		M	12/16/1998	sl soreness that has not resolved & has become increasingly painful;has firm area lt arm-sent to Md for follow up;				Y					U	11/05/1998	11/06/1998	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	CO98060	1						1	Injection site mass; Injection site pain	FLU3~MEDEVA PHARMA, LTD.~E20248KF~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0117596	12/22/1998	NY	46.0	46		M	12/21/1998	1 1/2 wk post vax pt devel paralysis;dx w/GBS post flu vax on life support;ventilator, plasma tx;			Y	Y	Y	30			N	11/14/1998	11/23/1998	9	CAT cardiogram, spinal tap;	OTH	OTH	Procardia;Monaxiprol;Ibuporphen;Indur;high blood pressure	NONE	high blood pressure, knee injury			1						1	Guillain-Barre syndrome; Haemorrhage; Hypoxia; Paralysis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0117600	12/22/1998	NY	74.0	74		M	12/15/1998	devel paresthesias of hands & legs w/numbness then progressive weakness arms & legs then resp depression requiring intubation secondary to GBS:			Y						N	11/13/1998	11/15/1998	2	CT dead & spine negative;LP inc protein;	PVT	PVT	Coumadin;Lasix	NONE	chronic long disease, sleep apnea, hx pulmonary embolus;asbestosis;	NA~ ()~~~In patient		1						1	Guillain-Barre syndrome; Hypoxia; Myasthenic syndrome; Paraesthesia; Respiratory disorder	FLU3~CONNAUGHT LABORATORIES~0975820~1~SC A~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~~1~SC A~~PNEUMO (PNU-IMUNE)~1	USA	Life Threatening	Influenza
0117603	12/22/1998	IL	36.0	36		F	12/14/1998	high fever (over 102 & @ one point over 103) & flu sx (muscle aches, chills, lethargy, nausea) for a period of 5 days;				Y					Y	12/03/1998	12/05/1998	2		PUB	PVT	NONE	NONE	allergic to sulfa drugs, dust, molds	~ ()~~~In patient		1						1	Influenza; Myalgia; Nausea; Pyrexia; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0117606	12/22/1998	NE	67.0	66		M		pt recv vax 20OCT97 & came to the Er on 21OCt97 w/a thick tongue, little difficulty breathing, some hives, gen pruritus;				Y					U	10/20/1997	10/21/1997	1		PVT	OTH		diminished pulmonary capacity		~ ()~~~In patient		1						1	Dyspnoea; Pruritus; Tongue oedema; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0117613	12/22/1998	TX	26.0	26		F	12/03/1998	itching all over, large local rxn, inc heart rate given medrol dose pack & told not to take flu vax again;				Y					Y	11/18/1998	11/19/1998	1	NA	PVT	PVT	NONE	NONE	allergic to ASA	~ ()~~~In patient	TX98183	1						1	Injection site reaction; Pruritus; Tachycardia	FLU3~PFIZER\WYETH~4988222~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0117617	12/22/1998	OH	42.0	42		F	12/04/1998	about 1/2hr p/vax 27OCT98 eyes began to burn & pt was having some breathing complications;there was no tx done for this rxn;pt was tired also afterward;									Y	10/27/1998	10/27/1998	0	no tests done p/event reported of reaction;	PVT	PUB	NONE	NONE	some normal allergies-change of seasons	NONE~ ()~~~In patient		1						1	Dyspnoea; Eye pain	FLU3~CONNAUGHT LABORATORIES~0983380~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117618	12/22/1998	MD	67.0	67		F	11/17/1998	the day p/vax in rt arm pt devel radicular-type pain in lt leg from buttock to foot;no preceding trauma, resolved p/6 days w/motrin;reported it because neighbor had the same thing;									Y	10/13/1998	10/14/1998	1	NONE	PVT	PVT	Plendil, HCTZ, Altace	NONE	HTN, overweight	~ ()~~~In patient		1						1	Pain	FLU3~MEDEVA PHARMA, LTD.~E20308LA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0117621	12/22/1998	CA	47.0	46		M	12/17/1998	pt reported by 9PM day of vax exp vomiting, muscle spasms, SOB, chills, hyperventilation;went to clinic next afternoon;told was vaccine reaction;									Y	10/28/1998			NONE	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Chills; Dyspnoea; Hypertonia; Hyperventilation; Vomiting	FLU3~CONNAUGHT LABORATORIES~0978710~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117622	12/22/1998	MT	8.0	8		F	12/15/1998	5 days p/vax pt started vomiting & then henoch-schonlein purpura set in & was seen by MD;									U	10/21/1998	10/26/1998	5	nl UA, non specific blood count;	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Purpura; Renal failure; Vasculitis; Vomiting	FLU3~CONNAUGHT LABORATORIES~0971890~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117640	12/22/1998	TX	63.0	63		F	11/20/1998	pt recv vax 12NOV98 & 20NOV98 Am arm where vax given was hard itching;states could feel swell knot also;9cm x 10cm red area w/o tenderness on palpation;area warm to touch;area is itchy;									Y	11/12/1998	11/20/1998	8	NA	PUB	PUB	NONE	NONE	NONE	NA~ ()~~~In patient	TX98175	1						1	Injection site hypersensitivity; Injection site mass; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975800~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~0944780~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0117644	12/22/1998	TX	58.0	58		F		local rxn-rash & itching-upper arm mild systemic-SOB;given zyrtec @ clinic-no further problems;									Y	10/29/1998	10/29/1998	0		PVT	OTH				~ ()~~~In patient	TX98187	1						1	Dyspnoea; Injection site hypersensitivity	FLU3~PARKDALE PHARMACEUTICALS~02198P~UNK~A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0117647	12/23/1998	NY	83.0	83		M	12/22/1998	Pt recv vax on 11/9/98; on 12/1/98 pt exp thrombocytopenia w/ petechia rash; tx=transfusion & steroids					Y	5			Y	11/09/1998	12/01/1998	22	Platelet count -0	PVT	PVT	Coumadin, Lasix, Kdur	UNK	Mitral valve replacement -1991; Septic shock w/ MSOF 9/98	UNK~ ()~~~In patient		1						1	Petechiae; Thrombocytopenia	FLU3~CONNAUGHT LABORATORIES~0984550~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0117652	12/23/1998	PA	1.3	1	.3	F	12/18/1998	Pt recv vax on 11/17/98; on 11/18/98 pt exp swollen Rt Arm									Y	11/17/1998	11/18/1998	1	NONE	PVT	PVT	Albuterol	Lymphadenopathy	Syphillis, RAD, Tracheomolia	NONE~ ()~~~In patient		1						1	Injection site oedema	FLU3~CONNAUGHT LABORATORIES~0984530~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117654	12/23/1998	CA	65.0	65		F	12/04/1998	Pt recv vax on 12/3/98; on same day pt exp chills, Rt Arm swollen at vax site; tx=ice									U	12/03/1998	12/03/1998	0	UNK	PUB	PUB	NONE	NONE	Atherosclerosis	NONE~ ()~~~In patient	CA980133	1						1	Chills; Injection site oedema	FLU3~MEDEVA PHARMA, LTD.~E20168HB~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0708H~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0116662	12/26/1998	FL	65.0	65		F	10/31/1998	prior to adverse even BP was 120/70;@ time of disorientation BP had risen to 170/120 & pt incoherent & amnesia had set in;pt bouncing off walls & unable to know name;doesn't remember being taken to hosp;monitored for stroke & memory loss				Y					Y	10/13/1998	10/13/1998	0		PVT	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient		1						2	Anxiety; Confusional state; Amnesia; Cerebrovascular accident; Depersonalisation; Hypertension; Nervousness; Thinking abnormal	FLU3~PARKDALE PHARMACEUTICALS~03088P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~455937~UNK~~LA~PNEUMO (PNU-IMUNE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0115506	12/28/1998	PA	32.0	32		F	12/16/1998	fever, vomiting, h/a, shivers;									Y	10/23/1998	10/23/1998	0		PUB	OTH	NONE	NONE	PCN, sulfa	NA~ ()~~~In patient		1						2	Myalgia; Pyrexia; Tremor; Vomiting; Headache; Pyrexia; Tremor; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0117658	12/28/1998	GA	34.0			M	12/16/1998	Pt recv vax on 11/8/98; on 11/22/98 pt exp muscular weakness to hands, then general weakness; progressed to paralysis; dx= Guillain Barre syndrome; pt hosp/ ICU; tx=plasmapheresis, intubated for ventilation			Y				Y		N	11/08/1998	11/22/1998	14	Neurological tests to dx GBS	OTH	OTH	NONE	UNK	NONE	UNK~ ()~~~In patient		1						1	Guillain-Barre syndrome; Myasthenic syndrome; Paralysis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0117663	12/28/1998	NY	64.0	64		F	12/23/1998	Pt recv vax on 10/20/98; on same day pt exp sharp pains in left ear & nasal drip, tired, not eating, weight loss, bronchitis & cough; dx=possible polyarteritis nodosa & Churg Strauss syndrome; tx=Prednisone				Y					N	10/20/1998	10/20/1998	0	12/2/98-Chest X-ray: lung inflammation; 11/30/98-high sedrate, elevated ANA; 11/30/98-pulmonary func test-poor; 11/11/98- high eosino, high sedrate; 11/9 anaemic elevated WBC	OTH	OTH	UNK	NONE	Hx of thyroiditis	UNK~ ()~~~In patient	MPI982107	1						1	Bronchitis; Ear pain; Leukocytosis; Lung disorder; Polyarteritis nodosa; Red blood cell sedimentation rate increased; Vasculitis; Weight decreased; Anaemia; Anorexia; Asthenia; Bronchitis; Ear pain; Polyarteritis nodosa; Rhinitis; Skin nodule; Vasculitis	FLU3~MEDEVA PHARMA, LTD.~E20218HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~E20218HA~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0117663	12/28/1998	NY	64.0	64		F	12/08/1998	Pt recv vax on 10/20/98; on same day pt exp post nasal drip, left ear pain, tired,appetite loss, weight loss,cough;tx=steroid inhaler, Prednisone, bronchodilator; dx=Churg-Strauss syndrome. Annual follow-up dated 02/15/01 provided no additional data.			Y	Y					N	10/20/1998	10/20/1998	0	Hemoglobin-anemia; WBC &platelets-increased; X-ray-pulmonary lesions; High esinophils; ESR-57 &67; pos ANA test   Perceptible SC nodules 11/25/98	PUB	OTH	Estrace, Provera	NONE	UNK			1						2	Bronchitis; Ear pain; Leukocytosis; Lung disorder; Polyarteritis nodosa; Red blood cell sedimentation rate increased; Vasculitis; Weight decreased; Anaemia; Anorexia; Asthenia; Bronchitis; Ear pain; Polyarteritis nodosa; Rhinitis; Skin nodule; Vasculitis	FLU3~MEDEVA PHARMA, LTD.~E20218HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~E20218HA~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Life Threatening	Influenza
0117675	12/28/1998	FL	27.0	27		F	12/17/1998	Pt recv vax on 10/22/92; on 11/1/98 pt exp shingles; Annual follow-up dated 02/21/01 provided no additional data.			Y	Y					N	10/22/1998	11/01/1998	10	UNK	PVT	PVT	NONE	NONE	NONE			1						1	Herpes zoster; Neuropathy	FLU3~CONNAUGHT LABORATORIES~0968410~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0117676	12/28/1998	PA	54.0	54		F	11/25/1998	Pt recv vax on 11/13/98; on 11/15/98 pt exp headache, fever, chills, abnormal spinal fluid; dx=aseptic meningitis					Y				Y	11/13/1998	11/15/1998	2	Glucose-47; Protein-206; CSF-11/16/98; WBC-529; Lymph-84%	PVT	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient	PA9872	1						1	CSF test abnormal; Headache; Meningitis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0117687	12/28/1998	LA	23.0	23		F	12/17/1998	Pt recv vax on 11/5/98; on 11/6/98 pt exp red whelps on entire body, itching &swelling around lips & face; tx=steroids & Zyrtec; dx=hives, allergic vasculitis				Y					Y	11/05/1998	11/06/1998	1	Undergoing M.D. care	PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	LA981202	1						1	Face oedema; Hypersensitivity; Pruritus; Urticaria; Vasculitis	FLU3~CONNAUGHT LABORATORIES~0975800~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117689	12/28/1998	NY	50.0			M	12/18/1998	Pt recv vax on 12/8/98; 4 hr post vax pt exp fever, chills, tight throat/ chest; tx=rest, drink fluids, Tylenol				Y					Y	12/08/1998	12/08/1998	0	NONE	PVT	PVT	Procardia XL, Atenolol	UNK	Unspecified cardiac condition	UNK~ ()~~~In patient		1						1	Chest pain; Laryngospasm; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0984530~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117692	12/28/1998	MN	44.0	44		F	12/16/1998	Pt recv vax on 10/27/98; post vax pt exp pain at vax site				Y					U	10/27/1998			UNK	PUB	PVT	UNK	UNK	Fibromyalgia	NONE~ ()~~~In patient		1						1	Injection site pain; Myalgia	FLU3~PFIZER\WYETH~4988204~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0117693	12/28/1998	CA	44.0	44		F	12/16/1998	Pt recv vax on 11/19/98; on 11/25/98 pt exp Guillain-Barre syndrome				Y					Y	11/19/1998	11/25/1998	6	EMG-12/9/98:  dx for GBS	OTH	PUB	Atenolol, Prilosec, Wellbutrin, Augmentin	NONE	Marfan syndrome, Breast cancer	UNK~ ()~~~In patient		1						1	Guillain-Barre syndrome; Laboratory test abnormal	FLU3~MEDEVA PHARMA, LTD.~E20148HF~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0117694	12/28/1998	MA	10.0	10		F	12/14/1998	Pt recv vax on 12/5/98; on 12/6/98 pt exp redness & swelling at vax site; dx=sterile abscess; tx=antibiotics				Y					Y	12/05/1998	12/06/1998	1	NONE	PUB	PUB	UNK	NONE	Allergic to Vauconegcia, Augmentin	NONE~ ()~~~In patient		1						1	Abscess; Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~0975780~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1173E~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0117699	12/28/1998	PA	44.0	44		F	11/19/1998	Pt recv vax on 11/18/98; on 11/19/98 pt exp erythema, warmth, tenderness at LA vax site				Y					Y	11/18/1998	11/19/1998	1	NONE	PVT	OTH	UNK	UNK	Allergic to Emycin, Penicillin, Naprosyn, Flonase	UNK~ ()~~~In patient	PA9871	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0978490~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1246H~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0117703	12/28/1998	PA	63.0	63		F	11/12/1998	Pt recv vax on 11/2/98; on 11/4/98 pt exp pain of LA, red/ swelling of LA; tx=Ceflexin				Y					Y	11/02/1998	11/04/1998	2	UNK	PUB	PUB	Lorazepam	NONE	Allergic to Penicillin, Sulfa, Cortisone	~ ()~~~In patient	PA9863	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0984530~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~0950740~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0117710	12/28/1998	WV	51.0	50		F	11/27/1998	pt recv vax 20NOV98 in the Am by afternoon site was red & swollen by that evening;pt had hives all over body, face was swollen;pt given rx strength DPh by MD;				Y					Y	11/20/1998	11/20/1998	0	NONE	OTH	OTH	Provera, lotensin	NA	high blood pressure	NA~ ()~~~In patient		1						1	Face oedema; Injection site oedema; Urticaria	FLU3~CONNAUGHT LABORATORIES~0975830~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117714	12/28/1998	TX	46.0	46		F	12/28/1998	onset optic neuritis rt eye approx 2wk post vax;visual acuity deteriorate to hand motion now improving on systemic steroids;									Y	10/27/1998	11/14/1998	18	MRI, blood work	MIL	MIL			NONE	~ ()~~~In patient		1						1	Optic neuritis	FLU3~PFIZER\WYETH~0970170~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0117716	12/28/1998	KS	62.0	62		F	09/30/1998	lt arm swelled @ inj site, hives on legs, fatigue;									Y	09/28/1998	09/28/1998	0	NONE	PUB	PVT	Nasacort nose spray;Allegra;	NONE	4 grasses, 4 trees, corn, pes, lettuce, pecans, tuna, salmon	NONE~ ()~~~In patient	KS98039	1						1	Asthenia; Injection site oedema; Urticaria	FLU3~CONNAUGHT LABORATORIES~0965780~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117717	12/28/1998	KS	81.0	81		M	10/15/1998	hives, severe itching started shortly p/7PM;still had some hives but was getting better by 15OCT98 9AM;pt started some DPH 6PM much better;									Y	10/14/1998	10/14/1998	0		PUB	PVT	Prilosec;Trimterene	NA	ulcer-allergic to PCN & sulfa;	~ ()~~~In patient	KS98040	1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~0973980~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117720	12/28/1998	KS	61.0	61		F	11/02/1998	Pt recv vax on 10/21/98; 6 hr post vax pt exp sore/ lump at vax site, migraine headache, runny nose, sore throat, fever (99-101)									Y	10/21/1998	10/21/1998	0	NONE	PUB	PVT	UNK	NONE	History of brain tumor; Allergic to egg protein-migraines	UNK~ ()~~~In patient	KS98044	1						1	Injection site mass; Injection site pain; Migraine; Pharyngitis; Pyrexia; Rhinitis	FLU3~MEDEVA PHARMA, LTD.~E20188HE~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0117721	12/28/1998	KS	71.0	71		F	10/26/1998	Pt recv vax on 10/16/98; on same day pt exp achy arm, swollen arm w/ rash, unable to move arm, fever (102); tx=Aspercreme									Y	10/16/1998	10/16/1998	0	UNK	PUB	PUB	UNK	UNK	UNK	UNK~ ()~~~In patient	KS98046	1						1	Hypokinesia; Myalgia; Oedema peripheral; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~0978720~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1508E~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0117722	12/28/1998	WV	46.0	46		F	11/20/1998	Pt recv vax on 11/19/98; on same day pt exp red/ inflamed vax area-LA; tx=Ibuprofen &ice									Y	11/19/1998	11/19/1998	0	NONE	OTH	OTH	Allergy injections	NONE	Allergic to pine, dogs, cats & molds	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site inflammation	FLU3~CONNAUGHT LABORATORIES~0975830~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117723	12/28/1998	WV	55.0	55		M	11/18/1998	Pt recv vax on 11/16/98; on 11/18/98 pt exp red vax site									N	11/16/1998	11/18/1998	2	NONE	OTH	OTH	NONE	NONE	Allergy to Erythrymycin	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~0975830~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117724	12/28/1998	WV	31.0	31		F	11/20/1998	Pt recv vax on 11/18/98; on 11/19/98 pt exp vax site redness									N	11/18/1998	11/19/1998	1	NONE	OTH	OTH	OTC antihistamine	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~0975830~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117725	12/28/1998	WV	54.0	54		F	11/18/1998	Pt recv vax on 11/17/98; on same day pt exp burning/ red vax site-LA									N	11/17/1998	11/17/1998	0	NONE	OTH	OTH	Ibuprofen, Methotrexate, Premarin	NONE	Arthritis, Allergic to Penicillin	Pt recv Flu vax in '96; exp same rx but worse~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0975830~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117726	12/28/1998	WV	23.0	23		F	11/19/1998	Pt recv vax on 11/16/98; on same day pt exp sore/ pain/ decreased mobility of LA & shoulder; tx=Ibuprofen, heat, ice									Y	11/16/1998	11/16/1998	0	NONE	OTH	OTH	Ortho Novum 777	NONE	NONE	NONE~ ()~~~In patient		1						1	Hypokinesia; Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~0975830~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117727	12/28/1998	WV				F	11/20/1998	Pt recv vax on 11/18/98; on 11/19/98 pt exp red/ edema/ tenderness of LA; tx=Tylenol & ice									N	11/18/1998	11/19/1998	1	NONE	OTH	OTH	Timerol	NONE	Glaucoma	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0975830~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117728	12/28/1998	WV	50.0	50		F	11/20/1998	Pt recv vax on 11/18/98; on same day pt exp tender, red vax site									N	11/18/1998	11/18/1998	0	NONE	OTH	OTH	Provera/ Estrogen, Lodine, Synthroid	NONE	NONE	Pt recv Fluzone vax 2 x in past; exp flu sx~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0975830~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117729	12/28/1998	WV	36.0	36		F	11/25/1998	Pt recv vax on 11/23/98; on same day pt exp tender, redness at vax site									N	11/23/1998	11/23/1998	0	NONE	OTH	OTH	NONE	NONE	Asthma	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0975830~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117730	12/28/1998	WV	47.0	47		F	12/07/1998	Pt recv vax on 11/19/98; on 11/20/98 pt exp long red area at vax site, itching of entire body; tx=Benadryl; pt imp 1- 2 wk									Y	11/19/1998	11/20/1998	1	NONE	OTH	OTH	NONE	NONE	Allergic to Tetanus, Sulfa, E-Mycin	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~0975830~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117731	12/28/1998	WV	33.0	33		F	11/18/1998	Pt recv vax on 11/16/98; on 11/17/98 pt exp hot, red vax site; tx=Ibuprofen, Benadryl & ice									Y	11/16/1998	11/17/1998	1	NONE	OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975830~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117732	12/28/1998	WV	26.0			F	11/18/1998	Pt recv vax on 11/16/98; on 11/17/98 pt exp LA soreness; tx=Tylenol/ Ibuprofen									Y	11/16/1998	11/17/1998	1	NONE	OTH	OTH	Trilevlen, Synthroid, Niferex	NONE	NONE	NONE~ ()~~~In patient		1						1	Pain	FLU3~CONNAUGHT LABORATORIES~0975830~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117733	12/28/1998	WV	28.0	28		M	11/18/1998	Pt recv vax on 11/16/98; on 11/17/98 pt exp red, tender vax site; 11/19/98 pt exp nausea & vomiting									N	11/16/1998	11/17/1998	1	NONE	OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Vomiting	FLU3~CONNAUGHT LABORATORIES~0975830~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117734	12/28/1998	WV	40.0	40		F	11/20/1998	Pt recv vax on 11/18/98; 2 hr post vax pt exp rash on stomach, chest & upper thighs; tx= Ibuprofen &Benadryl									Y	11/18/1998	11/18/1998	0	NONE	OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Rash	FLU3~CONNAUGHT LABORATORIES~0975830~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117735	12/28/1998	WV	27.0	27		F	11/18/1998	Pt recv vax on 11/16/98; on 11/17/98 pt exp pink at vax site									Y	11/16/1998	11/17/1998	1	NONE	OTH	OTH	NONE	NONE	Allergic to duck eggs, Cefzil	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~0975830~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117736	12/28/1998	WV	29.0	29		M	11/20/1998	Pt recv vax on 11/18/98; 2 hr post vax pt exp tender, warm, red vax site									N	11/18/1998	11/18/1998	0	NONE	OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975830~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117737	12/28/1998	WV	42.0	42		F	11/19/1998	Pt recv vax on 11/17/98; 2 hr post vax pt exp nausea, vomiting, chills, muscle aches & headache									N	11/17/1998	11/17/1998	0	UNK	OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Chills; Headache; Myalgia; Vomiting	FLU3~CONNAUGHT LABORATORIES~0975830~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117738	12/28/1998	WV	23.0	23		F	11/18/1998	Pt recv vax on 11/17/98; on 11/18/98 pt exp red vax site									N	11/17/1998	11/18/1998	1	NONE	OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~0975830~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117739	12/28/1998	WV	31.0	31		F		Pt recv vax on 11/17/98; on 11/19/98 pt exp red, warm vax site; tx=Tylenol, cold compress									N	11/17/1998	11/19/1998	2	NONE	OTH	OTH	NONE	NONE	Allergic to Penicillin	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975830~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117749	12/28/1998	MA	50.0	50		F	12/16/1998	Pt recv vax on 12/9/98; on 12/10/98 pt exp fever, joint aches, erythematous macular rash on neck, face & trunk									Y	12/09/1998	12/10/1998	1	NONE	PVT	PVT	UNK	NONE	Allergic to Penicillin & Bactrim	NONE~ ()~~~In patient		1						1	Arthralgia; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E20318LA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0117750	12/28/1998	CA	32.0	32		F	12/14/1998	Pt recv vax on 11/18/98; on 11/22/98 pt exp ascending motor weakness, Guillain-Barre syndrome; pt hosp; tx=medicine					Y				U	11/18/1998	11/22/1998	4	Pt to neurologist	PVT	PVT	Valium given 11/18	UNK	     began about 11/22, neck pain & strain	UNK~ ()~~~In patient		1						1	Guillain-Barre syndrome; Hypokinesia; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~0983298~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0117754	12/28/1998	SC				U		Pt recv vax on unknown day;  3 day post vax pt exp myalgia, fatigue, numbness									N				Sedrate 30; ANA-neg	PVT	PVT	UNK	NONE	NONE	NONE~ ()~~~In patient		1						1	Asthenia; Myalgia; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E20278KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0117756	12/28/1998	SC				F		4 days post vax severe myalgia;									N					PVT	PVT		NONE	NONE	NONE~ ()~~~In patient		1						1	Myalgia	FLU3~MEDEVA PHARMA, LTD.~E20278KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0117758	12/28/1998	IN	58.0	58		F	10/23/1998	very weak for about 2 1/2 days starting day p/vax;									Y	10/15/1998	10/16/1998	1		PUB	OTH				~ ()~~~In patient		1						1	Asthenia	FLU3~PFIZER\WYETH~498224~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0117759	12/28/1998	NY				U	12/15/1998	Pt recv vax on unknown day; post vax pt exp pancreatitis									U				UNK	OTH	OTH	Videx therapy	UNK	HIV infection	UNK~ ()~~~In patient	898351029A	1						1	Pancreatitis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0117763	12/28/1998	WA	13.0	13		M	12/11/1998	Pt recv vax on 11/14/98; on 11/28/98 pt exp Guillain Barre syndrome; pt hosp					Y	21			Y	11/14/1998	11/28/1998	14	UNK	OTH	PUB	Albuterol inhaler, Beclovent inhaler, Serevent inhaler	NONE	Asthma	UNK~ ()~~~In patient	898348034A	1						1	Guillain-Barre syndrome; Myasthenic syndrome	FLU3~PFIZER\WYETH~4988210~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0117784	12/29/1998	AK	68.0	68		M	12/17/1998	3 1/2wk p/vax devel pain, weakness & swelling in upper extremities;has trouble sleeping & weakness in the lower extremities;has problems getting up;seen by internist & neurologist (demyelinating disease;neuro feels this is secondary to GBS;				Y					N	09/25/1998	10/19/1998	24	pending LP;numerous tests EMG;	PVT	OTH		NONE	iodine allergy, asthma, cMV 1984, MI 1989, diabetes dx 7mo ago;	~ ()~~~In patient	AK98022	1						1	Asthenia; Guillain-Barre syndrome; Hypokinesia; Myasthenic syndrome; Neuropathy; Oedema peripheral; Pain	FLU3~MEDEVA PHARMA, LTD.~E20188HE~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0117788	12/29/1998	AK	48.0	48		F	11/12/1998	pt noticed chills afternoon of 20th;on awakening on the morning of the 22nd pt had a painful, swollen rt eye, aching eye & face & eruptions on face lasting 4-5 days;seen by MD dx shingles;				Y					Y	10/16/1998	10/20/1998	4	NONE	OTH	UNK		NONE	seizure disorder;subject to food allergies, pollen;had chickenpox in grade school;	~ ()~~~In patient	AK98027	1						1	Chills; Eye pain; Face oedema; Herpes zoster; Rash	FLU3~CONNAUGHT LABORATORIES~0973980~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~0944780~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0117790	12/29/1998	AK	37.0	37		F	10/06/1998	evening of 3OCT98 noticed area of redness morning of 4OCT98 woke up & redness inc, area warm to touch, & arm achy, indurated;presented to hlth center 5OCT98, area of redness 4 x 3/2, redness raised, area;warm to touch;itchy;dec achiness;				Y						10/03/1998	10/03/1998	0		OTH	OTH	NA	NA	NA	pt sibling exp redness, itch indurated, warm to touch w/flu & pneumovax;~ ()~~~In Sibling	AK98024	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Pruritus; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1540E~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0117801	12/29/1998	AK	46.0	46		F	11/16/1998	pt exp aches & pain;pt recv vax & woke up next day w/aches & pain in the muscles;antinuclear antibody was 1:640 & sed rate 38;negative double stranded DNA negative;negative anti ribonucleoprotein;Bouchard's & heberden's node;dx arthralgias;										09/10/1998	09/18/1998	8	antinuclear antibody positive;	OTH	PUB	NONE	NONE	NONE	~ ()~~~In patient	AK98019	1						1	Antinuclear antibody; Arthralgia; Arthritis; Myalgia; Red blood cell sedimentation rate increased	FLU3~CONNAUGHT LABORATORIES~0973980~6~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117802	12/29/1998	AK	33.0			F	09/18/1998	entire body ache started chills, cold, shivering, fever unk last 48hr before totally recovered;									Y	09/14/1998	09/14/1998	0	NONE	PVT	PUB	Calcium carbonate	NONE	phenylpropanolamine-hives	~ ()~~~In patient	AK98020	1						1	Chills; Myalgia; Pyrexia; Tremor	FLU3~CONNAUGHT LABORATORIES~0973980~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117805	12/29/1998	AK	55.0	55		F	10/12/1998	1hr p/vax pt lt upper arm began to hurt;began swell & have inc pain;9OCT98 lt upper arm skin was sl taut & swollen over deltoid;sl red spotted area lower edge of muscle line;sl warm to touch;c/o pain w/any movement;									Y	10/08/1998	10/08/1998	0	NA	PUB	PUB	Estrase	NONE	hormone replacement tx;prev sulfa allergy;tx bursitis lt shoulder;	~ ()~~~In patient	AK98025	1						1	Injection site oedema; Injection site pain; Pain; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0973980~5~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1173E~2~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0117806	12/29/1998	AK	67.0	67		F	10/19/1998	blisters under breasts red & raised 330PM Friday;lt arm felt paralyzed-weak, black & blue by evening-hot to touch-3 x 6, chills;painful on saturday;took DPH;									Y	10/16/1998	10/16/1998	0		PUB	UNK		not ill	pollen allergy-some food allergies-no eggs;	~ ()~~~In patient	AK98028	1						1	Chills; Dermatitis bullous; Ecchymosis; Myasthenic syndrome; Pain; Paralysis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0973980~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1173E~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0117814	12/30/1998	IL	50.0	50		F	12/22/1998	pt recv vax 14OCT98 & on 24NOV98 devel numbness/tingling to extremities & polyneuropathy consistent w/GBS;					Y	14			Y	10/14/1998	11/24/1998	41	plasmaphoresis IGG	PVT	PVT	Insulin, Prylosec, anti	gastritis	DM, CAD, HPN	~ ()~~~In patient		1						1	Guillain-Barre syndrome; Neuropathy; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0971060~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0117815	12/30/1998	MN	67.0	67		F	12/23/1998	development of GBS requiring hospitalization & plasmapheresis;			Y	Y	Y				Y	11/23/1998	11/30/1998	7	CPK 200;ESR 21;EMG study dx of GBS;	PVT	PVT	Premarin;Medrol;Calcium;	NONE	chronic bronchiectasis, leg deep veins thrombosis (post operative);			1						1	Blood creatine phosphokinase increased; Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~0985920~5~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0117821	12/30/1998	NC	52.0	52		F	12/18/1998	28NOV98 started itching on lower leg & then noted rash on both legs cont to get worst;3DEC98 seen by dermatologist sx on both lower legs & stomach;rash progressed up both legs;				Y					Y	11/23/1998	11/28/1998	5	comprehension metabolic profile;UA;bx of lesion;CBC;PT/PTT;ANA;	PUB	PVT	HCTZ	NONE	kidney stones	~ ()~~~In patient		1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~0985920~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117826	12/30/1998	NC	60.0	59		M	11/20/1998	pt recv vax 14NOV98 & 21OCT98 pt began having itching & hives;took DPH, no relief;pt spouse called pvt MD & was given rx for dose pack;pt cont to have intermittent swelling of lips & eyelids;									N	10/14/1998	10/21/1998	7	NONE	PUB	PUB	unk	NONE		~ ()~~~In patient	NC98075	1						1	Face oedema; Pruritus; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E20188HE~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1510E~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0117830	12/30/1998	IL	48.0	48		M	12/22/1998	pt recv vax ?;26NOV98 devel weakness, paresthesia in upper & lower extremities w/severe back pain;some dysphasia & dec resp;					Y	14			N	11/09/1998	11/26/1998	17	GBS	PVT	PVT	Prevacid	none	hodgkins disease 1990	~ ()~~~In patient		1						1	Back pain; Guillain-Barre syndrome; Hypoventilation; Myasthenic syndrome; Paraesthesia; Speech disorder	FLU3~CONNAUGHT LABORATORIES~0971060~7+~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0117831	12/30/1998	AZ	60.0	60		F	12/20/1998	localized induration, hyperemia, tenderness upper rt arm 10cm area noted diameter;									Y	10/21/1998	10/22/1998	1	NONE	PVT	PVT	female hormones;fossamex	NONE	INH-nasal allergies	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20228KC~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0117833	12/30/1998	CA	50.0			F		c/o muscle spasms, weakness, ataxia, panic attacks;went to PMD;19NOV saw MD did not believe shot was connected to sx;saw neuro 15DEC98; doing CT scan today;EEG scheduled;									U	10/18/1998	10/19/1998	1	15DEC98 CT scan;EEG scheduled	OTH	PUB			hx of allergy to soy, corn, agglutin;parathyroid disease;celiac disease	pt exp muscle spasms, weaknes, ataxia, panic attacks @ 49yr old w/flu vax;~ ()~~~In patient		1						1	Agitation; Asthenia; Coordination abnormal; Hypertonia	FLU3~MEDEVA PHARMA, LTD.~E20168HB~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0117839	12/31/1998	MD	41.0	41		F	11/02/1998	about 48hr p/vax noticed some itching which persisted for 3 days;on 5th day post vax had some breathing difficulty in afternoon;6th dasy post vax awoke w/swollen face;did not seek treatment for diff breathing or swelling in face;			Y						Y	10/26/1998	10/28/1998	2	NONE	PUB	PUB	NONE	NONE	allergy to latex, seasonal allergies;	NONE~ ()~~~In patient	MD98024	1						1	Dyspnoea; Face oedema; Pruritus	FLU3~MEDEVA PHARMA, LTD.~E20148HE~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening	Influenza
0117841	12/31/1998	DE	1.6	1	.6	M	12/28/1998	fever to 104 R, irritable, pain, local swelling;				Y					Y	12/08/1998	12/08/1998	0	NONE	PVT	PUB	NONE	NONE	ventriceloseptal defect-s/p repair, lt club foot	~ ()~~~In patient		1						1	Agitation; Injection site oedema; Pain; Pyrexia	DTAP~UNKNOWN MANUFACTURER~~UNK~~~DTAP (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~0978490~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~CONNAUGHT LABORATORIES~0934450~4~IM~LA~HIB (PROHIBIT)~1	USA	Emergency room visit	Influenza
0117842	12/31/1998	MN	48.0	48		F	11/16/1998	pt recv vax 5NOV98 8AM & 1030AM exp h/a, nausea, scratchy throat & flushed feeling;12:00 difficulty breathing, felt warm from chest & up, chest felt heavy;110PM eyes swollen, chest tight heavy, dyspneic, throat tight sore;				Y					Y	11/05/1998	11/05/1998	0	NONE	PUB	PUB	Zantac;Atenolol;Ascriptin;HCTZ;	currently having GI work up (no diagnosis)	HTN, no prev allergies;	NONE~ ()~~~In patient	MN98028	1						1	Chest pain; Dyspnoea; Lacrimal disorder; Laryngospasm; Nausea; Pharyngitis; Pruritus; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~00508P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~SMITHKLINE BEECHAM~2589A4~1~IM~RA~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0117844	12/31/1998	WI	38.0	38		F	11/12/1998	myalgias, fever;amantadine;				Y					Y	10/26/1998	10/28/1998	2		PVT	PVT			motrin, ASA	~ ()~~~In patient		1						1	Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0963880~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117845	12/31/1998	WI	51.0	51		M	11/11/1998	myalgias, muscle weakness				Y					Y	10/21/1998	10/21/1998	0		PVT	PVT	Buspar	NONE		~ ()~~~In patient		1						1	Myalgia; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~0968380~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117846	12/31/1998	WI	10.0	10		F	11/12/1998	myalgias, fever;				Y					Y	10/30/1998				PVT	PVT				~ ()~~~In patient		1						1	Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0963830~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117847	12/31/1998	MI	26.0	26		F	12/18/1998	pt reported soreness, tenderness of rt arm-entire upper area & swelling which was subsiding;unk whether or not had fever;c/o h/a;had MD appt, MD gave APAP;				Y					Y	12/14/1998	12/15/1998	1	NONE	PUB	PUB	NONE	NONE	NONE	pt exp fever, sore arm w/DTP~ ()~~~In patient	MI99001	1						1	Headache; Injection site oedema; Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~03088P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~CONNAUGHT LABORATORIES~0963390~2~~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0117848	12/31/1998	SC	37.0	37		F	12/08/1998	pt reports 24hr p/vax began exp chest pain & epigastric region shooting across both breasts lasting 4hr;pt reports went to PMD 6NOV98 @ 215PM;exp flu like rxn;T99.3;				Y					Y	11/04/1998	11/05/1998	1	EKG WNL;	PUB	UNK		NONE	NKA, diagnosed w/schizophrenia 10 years ago	~ ()~~~In patient	SC98087	1						1	Abdominal pain; Chest pain; Influenza; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0981810~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117856	12/31/1998	FL	56.0	56		F	12/21/1998	since vax on 22OCT98 lt arm remains sore & painful;									Y	10/22/1998	10/23/1998	1	NONE	PUB	PUB	NONE	NONE	SOD, bisulfate (diarrhea) codeine	~ ()~~~In patient	FL98063	1						1	Injection site pain	FLU3~MEDEVA PHARMA, LTD.~E20158HF~1~IM L~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0117857	12/31/1998	VA	57.0	57		F	12/10/1998	no fever; achy all over;noted red area rt arm on 5DEC98;area approx 2in wide swollen, sore, hot to touch;by evening of 5DEC98 pt noted redness to underside of rt arm;									Y	12/04/1998	12/05/1998	1	NA	PUB	PUB		NA	NA	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Myalgia; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~00508P~4~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~454969~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0117859	12/31/1998	SC	59.0	59		F	12/08/1998	pt recv vax 4DEC98 & immed noticed warm feeling in rt arm;noticed pain, redness, swelling around 7-8PM;stated arm was so sore couldn't stand to touch it;had h/a & generalized body aches;area warm, indurated, sore, itchy;									N	12/04/1998	12/04/1998	0	NONE	OTH	PUB	premarin, vitamins;Ginseng, herbs	NONE	sulfa, tetanus	~ ()~~~In patient	SC98093	1						1	Hyperaesthesia; Injection site mass; Injection site oedema; Injection site pain; Myalgia; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0980580~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0871H~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0117862	01/04/1999	OH	80.0	80		F	12/29/1998	pt recv vax 19OCT98 & 22OCT98 pt reportedly devel bilat weakness in both legs progressing to paralysis;					Y				N	10/19/1998	10/22/1998	3		PVT	PVT	Glucophage,Amaryl	NONE	diabetes, HTN	~ ()~~~In patient	U199800698	1						1	Guillain-Barre syndrome; Myasthenic syndrome; Paralysis	FLU3~CONNAUGHT LABORATORIES~0965770~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0117873	01/04/1999	OK	63.0	63		M	12/21/1998	GBS dx 18DEC98?;sx began w/pain in legs progressed to weakness of legs, unable to walk then, loss of tx of arms;under care of MD;			Y	Y	Y	28	Y		N	10/09/1998	10/31/1998	22		PUB	PUB	experimental tx for CA	CA brain stem behind sinus (?)	immunospuressed-chemo (Naso-pharynx carcinoma)	NONE~ ()~~~In patient	OK9850	1						1	Guillain-Barre syndrome; Hypokinesia; Myasthenic syndrome; Pain	FLU3~PFIZER\WYETH~4988216~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0117887	01/04/1999	LA	16.0			M	12/23/1998	Pt recv vax on unknown day;  post vax pt exp passing out x 5 min									Y				Blood pressure 160/80; Pulse irregular	PUB	PUB	NONE	NONE		UNK~ ()~~~In patient	LA981204	1						1	Arrhythmia; Hypertension	FLU3~CONNAUGHT LABORATORIES~0975800~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~04374~1~~RA~HIB (PEDVAXHIB)~1|TD~LEDERLE LABORATORIES~455935~6~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0117943	01/04/1999	WI	50.0	50		M	12/15/1998	fever 102+ w/streptococcus pneumoniae bacteremia confirmed by blood cult 10DEC98;			Y		Y	3			Y	12/09/1998	12/09/1998	0	blood cult, CBC, urine cult	PVT	PVT	unk	NONE	s/R bone marrowtransplant for multiple wyetoma graft vs host disease	NONE~ ()~~~In patient	FLU92181298	1						1	Infection; Pneumonia; Pyrexia; Dizziness; Influenza; Laboratory test abnormal; Malaise; Sepsis	FLU3~PARKDALE PHARMACEUTICALS~02198P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~456690~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1|FLU3~CONNAUGHT LABORATORIES~02198P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~456690~UNK~IM~LA~PNEUMO (PNU-IMUNE)~2	USA	Life Threatening,Hospitalisation	Influenza
0117906	01/05/1999	UT	75.0	75		M	12/23/1998	Pt recv vax on 11/30/98; on 12/1/98 pt exp coldness, fever; on 12/2/98 pt exp hotness; collapsed; pt died	Y	12/02/1998							N	11/30/1998	12/01/1998	1	UNK	PVT	PUB	Cordarone	NONE	Allergic to PCN, Irregular heart beat, ventricular arrhythmia(declined implantable defibrillator, CABG x3 in 1995, ischemic cardiomyapathy, heavy drinker, hearing aid	UNK~ ()~~~In patient	UT981825	1						1	Condition aggravated; Pyrexia; Shock	FLU3~PFIZER\WYETH~498819~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0117908	01/05/1999	CA	0.9	0	.9	F	12/28/1998	pt recv vax 27OCT98  & 10NOV severe vomiting, glucose 92, felt prob viral age;25NOV seen for OM;29NOV cranky, some vomiting w/nl exam;sl weight loss;3DEC vomited againx2;dx DKA w/glucose 1310;	Y	12/12/1998							N	10/27/1998	11/10/1998	14	glucose on admission 1310;NA 124;BUN 31;SGPT 26;CREAT 0.3;SGOT 42;	PVT	PVT	Beclovent inhaler		asthma, rt lower lobe infiltrate, innocent murmur	NONE~ ()~~~In patient		1						1	Agitation; Alanine aminotransferase increased; Aspartate aminotransferase increased; Blood urea increased; Brain oedema; Coma; Diabetes mellitus; Gastroenteritis; Hyperglycaemia; Hyponatraemia; Infection; Ketosis; Vomiting; Weight decreased	FLU3~PFIZER\WYETH~4988202~1~IM~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0117911	01/05/1999	UT	14.0	14		M	12/18/1998	Pt recv vax on 11/13/98; on 11/14/98 pt exp fever (101-103), warm/ red/ tender/ sore/ swollen vax site-LA, not eating; tx=Tylenol/ Motrin, antibiotics				Y					Y	11/13/1998	11/14/1998	1	Blood culture negative for bacteria	PUB	PUB	NONE	NONE	Hx of bacterial pneumonia	NONE~ ()~~~In patient	UT981826	1						1	Anorexia; Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4988200~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~SMITHKLINE BEECHAM~2710A2~1~IM~RA~HEP B (ENGERIX-B)~1|HEPA~MERCK & CO. INC.~~1~IM~RA~HEP A (VAQTA)~1|PPV~MERCK & CO. INC.~1247H~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0117914	01/05/1999	TX	60.0	60		F	12/20/1998	pain & weakness, +swelling of lt arm, problems persisted until tx w/immunobiosis tx as per MD;skin test for egg was negative;treated 6NOV98;				Y					Y	10/23/1998	10/23/1998	0		OTH	PVT	ASA, Estrogen	NONe	HTN	~ ()~~~In patient		1						1	Myasthenic syndrome; Oedema peripheral; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0117917	01/05/1999	NY	49.0	49		F	12/31/1998	pt recv vax 20OCT98 6PM by 9PM felt very tired & throat felt strange;430Am awoke & upper lip & face especially the lt side were swollen & joints were swollen & ached;p/ 2 days lip & face were down;joints gave pt problems for 6wk;									Y	10/20/1998	10/20/1998	0	blood work done by MD	PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Arthralgia; Asthenia; Face oedema; Insomnia; Laryngospasm	FLUX~UNKNOWN MANUFACTURER~~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0117940	01/07/1999	IL	26.0			F	12/23/1998	approx 6hr p/vax pt became warm w/face & chest erythema & SOB;rxn was treated w/DPH & EPI w/resolution over 30min;				Y					Y	10/27/1998	10/27/1998	0		UNK	UNK	Birth control pills		NKA;prev flu shot w/no reaction	~ ()~~~In patient		1						1	Dyspnoea; Rash; Vasodilatation	FLU3~PFIZER\WYETH~02788P~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0117948	01/07/1999	MD	33.0	33		F	11/06/1998	pt began itching on Friday noc, & rash broke out the next morning;5NOV98 MD dx allergic rxn to flu shot;hydrocortosone inj & 2 creams;				Y					Y	10/28/1998	10/30/1998	2	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MD99002	1						1	Hypersensitivity; Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0117957	01/07/1999	PA	39.0	39		F	12/31/1998	24-48hr p/vax fatigue, fever 102, lt arm red, sore, achy, chest lightness, lt shoulder soreness rash (fine papular) on neck & trunk;area of erythema lt arm 8x5cm;									Y	10/23/1998			NONE	PVT	OTH	Ibuprofen;Tribulen	NONE	med allergies;Emycin, PCN, sulfa	NONE~ ()~~~In patient		1						1	Asthenia; Chest pain; Myalgia; Pyrexia; Rash; Rash maculo-papular; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0966960~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~~1~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0117960	01/07/1999	VA	47.0	47		F		fever, muscle aches, difficulty breathing, paleness, weakness, difficulty swallowing;									Y	10/28/1998	10/30/1998	2		OTH	OTH				~ ()~~~In patient		1						1	Asthenia; Dysphagia; Dyspnoea; Myalgia; Pallor; Pyrexia	FLU3~PFIZER\WYETH~4978178~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0117961	01/07/1999	NY	65.0	65		F	12/19/1998	pt recv vax 7OCT98 lt arm;called office 9OCT98 c/o rash & pain in lt arm to elbow;no warmth to touch;no swelling;rash spread to other arm;										10/07/1998	10/07/1998	0		UNK	UNK	NONE			~ ()~~~In patient		1						1	Pain; Rash	FLUX~UNKNOWN MANUFACTURER~0978660~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0117962	01/07/1999	UT	30.0	30		F	12/09/1998	2hr p/vax pt started excessive coughing & having rapid, shallow breathing lasted approx 4hr;										11/12/1998	11/12/1998	0		UNK	UNK			NONE	~ ()~~~In patient		1						1	Cough; Hyperventilation; Hypoventilation	FLU3~PARKDALE PHARMACEUTICALS~00408P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0117963	01/07/1999	MA	53.0	53		F	11/10/1998	48hr p/vax localized swelling, pain, erythema 4.1x7.8cm induration lt arm lower area of deltoid;sx lasted >2wk urticaria;									Y	10/26/1998	10/27/1998	1	NONE	PVT	PVT	NONE	NONE	obesity/early glaucoma	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Urticaria	FLU3~PFIZER\WYETH~4988206~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0117967	01/07/1999	MA	53.0	53		F	11/17/1998	4.2 x 4.2 area of erythema, swelling, induration very low on lt upper arm almost in area of bicep;sx lasted 48hr;									Y	10/26/1998	10/28/1998	2	NONE	PVT	UNK		NONE	lt thumb surg 1OCT98	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4988221~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0117968	01/07/1999	MA	36.0	36		F	11/18/1998	3x2cm area of raised indurated erythema in area of lt bicep, anteriorly sl bicepital tenderness;resolved p/4 days small area of sl erythema on 18NOV98 @ site;									Y	10/26/1998	10/26/1998	0	NONE	PVT	PVT	NONE	NONE	traumatic amputation lt aKA only	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~PFIZER\WYETH~4988221~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0117970	01/07/1999	AL	45.0	45		F	11/25/1998	pt recv vax @ approx 2PM 24NOV98 & 6PM had some wheezing, rapid heart beat & felt weak;									Y	11/24/1998	11/25/1998	1	NA	PUB	PUB				~ ()~~~In patient	AL9817	1						1	Asthenia; Asthma; Tachycardia	FLU3~CONNAUGHT LABORATORIES~0978490~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117971	01/07/1999	MA	52.0	52		F	11/17/1998	3.0 x 5.7cm area of erythema, swelling pain warmth tender & painful induration;negative lymphadenopathy;sx greater than 1wk;									Y	10/26/1998	10/27/1998	1	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4988221~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0117982	01/08/1999	IN	19.0	19		F	12/29/1998	Pt recv vax on 12/21/98; on 12/22/98 pt exp sore vax site w/ redness, hard, warmth; tx=Benadryl, ice, Cetaflexin				Y					Y	12/21/1998	12/22/1998	1	NONE	PVT	PVT	Darvocet, Ceftin	Laryngotrachea bronchitis	Spleenectomy 1989	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02198P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~451490~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0117984	01/08/1999	MD	54.0	54		F	01/05/1999	Pt recv vax on 10/26/98; on 10/30/98 pt exp autoimmune rx of sore throat, fever, stomach pain, joint pain, blood in urine; serum sick;				Y					Y	10/26/1998	10/30/1998	4	Lab tests-all negative; antinuclear antibodies 1:40	PUB	PUB	UNK	NONE	Asthma, Chronic rhinitis	UNK~ ()~~~In patient		1						1	Abdominal pain; Antinuclear antibody; Arthralgia; Haematuria; Pharyngitis; Pyrexia; Serum sickness; Systemic lupus erythematosus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0117996	01/08/1999	MD	6.0	6		F	12/20/1998	Pt recv vax on 12/8/98; on 12/10/98 pt dx=Guillain Barre syndrome					Y	5			Y	12/08/1998	12/10/1998	2		PVT	PVT	UNK	low back pain to hips & legs, unsteady gait	NONE	UNK~ ()~~~In patient		1						1	Condition aggravated; Guillain-Barre syndrome; Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~0984570~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0984570~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0117981	01/11/1999	NJ	56.0	56		M	01/06/1999	Pt recv vax on 9/30/98; post vax pt exp shoulder pain at vax site; pain when shoulder rotation; joint pain in legs				Y					N	09/30/1998	09/30/1998	0	NONE	PVT	PVT	Prednisone	UNK	Occular myasthenia	UNK~ ()~~~In patient		1						1	Arthralgia; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0975820~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0117993	01/11/1999	GA	69.0	69		F	12/01/1998	Pt recv vax on 11/18/98; on same day pt exp pain in LA w/ motion pain; tx=moist heat to arm & anti-inflammatory medicine				Y					N	11/18/1998	11/18/1998	0	NONE	PUB	PUB	NONE	NONE	NONE	UNK~ ()~~~In patient	GA98125	1						1	Pain	FLU3~PFIZER\WYETH~4988206~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1095H~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0117994	01/11/1999	GA	59.0	59		F	11/17/1998	Pt recv vax on 11/16/98; on 11/17/98 pt exp red, hot, edema, pain of LA; tx=Cortisone injection, Advil, moist heat				Y					U	11/16/1998	11/17/1998	1	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	GA98123	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4988208~7+~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1247H~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0117995	01/11/1999	FL	44.0			F	01/08/1999	Pt recv vax on 10/14/98; on 11/18/98 pt exp retinal edema, decreased vision, dilated pupils; pt to see ophthalmologist				Y					N	10/14/1998	11/18/1998	35	Pt is undergoing test	PVT	PVT	UNK	NONE	NONE	UNK~ ()~~~In patient		1						1	Mydriasis; Retinal oedema; Visual disturbance	FLU3~MEDEVA PHARMA, LTD.~E2016811C~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0117998	01/11/1999	WV	22.0	22		F	11/19/1998	Pt recv vax on 11/17/98; on 11/18/98 pt exp red vax site w/ warmth; tx=Tylenol, cold compresses									N	11/17/1998	11/18/1998	1	NONE	OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975830~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0117999	01/11/1999	WV	21.0	21		F	11/19/1998	Pt recv vax on 11/17/98; on 11/18/98 pt exp red vax site w/ warmth; tx=Tylenol, cold compresses									N	11/17/1998	11/18/1998	1	NONE	OTH	OTH	Pt is on a BCP	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975830~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0118000	01/11/1999	GA	1.46	1	.5	M	05/26/2000	Pt recv vax on 11/16/98; on same day pt exp soreness of vax site w/ redness & hot. Follow up: No additional information.									Y	11/16/1998	11/16/1998	0	UNK	UNK	UNK	NONE	NONE	NONE		GA98124	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~4988208~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1247H~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0118001	01/11/1999	GA	77.0	77		F	10/02/1998	Pt recv vax on 10/1/98; on same day pt exp achy feeling, sore arm, backache, headache, not sleeping well; tx=Tylenol									U	10/01/1998	10/01/1998	0	NONE	PUB	PUB	Premarin	NONE	NONE	NONE~ ()~~~In patient	GA98126	1						1	Back pain; Headache; Injection site pain; Insomnia; Myalgia	FLU3~CONNAUGHT LABORATORIES~0975850~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0118002	01/11/1999	GA	65.0	64		F	12/14/1998	Pt recv vax on 12/8/98; on same day pt exp fever, sore throat, chest congestion, hoarseness, dizziness, wheezing, difficulty breathing; tx=Tylenol & orange juice									Y	12/08/1998	12/08/1998	0	UNK	PUB	PUB	UNK	NONE	NONE	NONE~ ()~~~In patient	GA98127	1						1	Asthma; Dizziness; Dysphonia; Dyspnoea; Lung disorder; Pharyngitis; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E20098GB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0118009	01/11/1999	MA	37.0	37		F	11/18/1998	Pt recv vax on 10/26/98; six hr post vax pt exp erythema, raised, indurated, hot vax site w/ urticaria & itching									Y	10/26/1998	10/26/1998	0	NONE	PVT	PVT	Prventil, Claritin	NONE	Seasonal allergies, Asthma	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pruritus; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4988221~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118010	01/11/1999	MA	36.0	36		F	11/17/1998	Pt recv vax on 10/26/98;on 10/27/98 pt exp raised erythematous indurated, warm, sore area > 1wk									Y	10/26/1998	10/27/1998	1	NONE	PVT	PVT	Steroids PRN, Ventolin inhaler PRN	NONE	Asthma	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4988221~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118011	01/11/1999	MA	28.0	28		F	11/18/1998	Pt recv vax on 10/26/98; on 10/27/98 pt exp erythema, swelling, induration of LA x 4-5dy									Y	10/26/1998	10/27/1998	1	NONE	PVT	OTH	UNK	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~PFIZER\WYETH~4988221~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118014	01/11/1999	MO	51.0	51		F	11/25/1998	Pt recv vax on 11/19/98; on 11/21/98 pt exp deep muscle fatigue in arm w/ painful aching when arm raised									U	11/19/1998	11/21/1998	2	UNK	PUB	PUB	Lotensin, HRT	NONE	High blood pressure	NONE~ ()~~~In patient	MO99001	1						1	Myalgia; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~0983310~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~0967100~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0118015	01/11/1999	SC	80.0	79		F	11/16/1998	Pt recv vax on 10/19/98; on 10/20/98 pt exp Rt arm swollen & red, fever x 1-2 day; tx=Tylenol									Y	10/19/1998	10/20/1998	1	UNK	PUB	OTH	UNK	NONE	NONE	UNK~ ()~~~In patient	SC98088	1						1	Injection site hypersensitivity; Injection site oedema; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0986580~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1278E~1~SC~RA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~0963390~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0118016	01/11/1999	SC	65.0	65		F	11/16/1998	Pt recv vax on 10/26/98; on 10/27/98 pt exp lower Rt arm red & know, fever (100) x 1-2 day									Y	10/26/1998	10/27/1998	1	UNK	PUB	OTH	Diahinese daily	NONE	Diabetes	UNK~ ()~~~In patient	SC98089	1						1	Injection site hypersensitivity; Injection site mass; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0984530~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1095H~1~SC~RA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~0963390~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0118035	01/12/1999	MN	34.0	34		M	10/06/1998	pt recv vax 745AM came back to nurse 9:45;stated vomited, felt chilled;pt is asthmatic;uses inhaler for wheezing;pt stated had stomach flu/bronchitis 1mo earlier;pt vomited x1, chills, T97.2;				Y						10/06/1998	10/06/1998	0	BP 140/92, P64, R16;	OTH	PVT				~ ()~~~In patient		1						1	Chest pain; Chills; Condition aggravated; Hypertension; Hypothermia; Hypoventilation; Vomiting	FLU3~CONNAUGHT LABORATORIES~0975800~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0118036	01/12/1999	MN	49.0	49		F	10/24/1998	eyes very reddened-blurred;lump in throat, sl difficulty breathing;recv flu vax 2:30 came back 810PM sx had progressed over 5hr;911 called;IV DPH & meds for nausea given;weakened & body ache;could hardly walk;migraine;felt like had flu;				Y					Y	10/23/1998	10/23/1998	0		PUB	OTH	NONE	NONE	pt daughter exp severe reaction to walnuts & PCN & some antibiotics-hives;carries epi pen;	NONE~ ()~~~In patient		1						1	Amblyopia; Asthenia; Conjunctivitis; Dyspnoea; Hypokinesia; Influenza; Laryngospasm; Migraine; Myalgia; Nausea	FLU3~CONNAUGHT LABORATORIES~0980530~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0118037	01/12/1999	MN	32.0	32		M	10/10/1998	flushed, inc pulse, SOB, BP @ 2:40 140/104, 96;2:37 138/100, P96;2:42 P120 SOB;2:45 150/100, P100;2:49 P116;rash belly-wrist;later went home had reaction to adrenalin  @ home w/SOB;				Y					Y	10/10/1998	10/10/1998	0		OTH	PVT		NONE	wheat, dust mites, dog & cat dander, pollen	~ ()~~~In patient		1						1	Dyspnoea; Hypertension; Rash; Tachycardia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975800~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0118038	01/12/1999	MN	37.0	37		F	10/23/1998	10min p/vax pt did not feel well;RN called to pt who was seated in a chair w/head between knees;pt very faint;BP 80/40;pt stated felt like was going to pass out;pt tipping over to one side;malaise;sweating;pale;shaking;milk allergy				Y					Y	10/23/1998	10/23/1998	0		OTH	PVT				~ ()~~~In patient		1						1	Coordination abnormal; Dizziness; Hyperhidrosis; Hypersensitivity; Hypotension; Malaise; Pallor; Tremor	FLU3~CONNAUGHT LABORATORIES~0981820~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0118039	01/12/1999	MN	34.0	34		F	10/05/1998	pt recv vax 130PM & 10min p/ c/o diaphoresis & severe abd cramping VS BP 118/70, HR 70 & RR16;lungs clear;EMS notified given epi;VS 155PM BP 120/72, HR 64, RR18;pt exp high BP, h/a;weak seen by MD;				Y					Y	10/05/1998	10/05/1998	0		OTH	PVT	unk	NONE	NONE	~ ()~~~In patient		1						1	Abdominal pain; Asthenia; Headache; Hyperhidrosis; Hypertension; Hypotension; Hypoventilation	FLU3~CONNAUGHT LABORATORIES~0975800~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0118040	01/12/1999	MN	53.0	53		F	10/15/1998	12:45 sweating 168/98 12:55, 1148/96 1:00, 140/96 1:05, 146/90 1:15 feels dazed;sl stiff neck, throat thickening, vision feels not quite right, h/a;sx for 3 days weakness, tired, not feeling well;										10/15/1998	10/15/1998	0		PVT	PVT	KCL, Mag, Estrase, Hydrochlorothiazide			~ ()~~~In patient		1						1	Asthenia; Headache; Hyperhidrosis; Hypertension; Laryngospasm; Malaise; Nuchal rigidity; Stupor; Visual disturbance	FLU3~CONNAUGHT LABORATORIES~0981820~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0118041	01/12/1999	MN	10.0	10		M	10/09/1998	pt feels woozy p/vax;w/in a maximum of 5min mom of child called nurse;pt had arms crossed  was exhibiting signs of sx: convuls became pale then tinged w/blue green;bluish in color & not breathing;sweat;thirsty;resp 15-20;P64, BP 78/50;									Y	10/09/1998	10/09/1998	0		OTH	PVT		NONE	past sz activity	~ ()~~~In patient		1						1	Apnoea; Asthenia; Condition aggravated; Convulsion; Cyanosis; Dizziness; Hyperhidrosis; Hypotension; Hypoventilation; Pallor; Tachycardia; Thirst	FLU3~CONNAUGHT LABORATORIES~0975800~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0118042	01/12/1999	MN	24.0	24		M	10/29/1998	pt recv vax & lying on back on floor w/eyes open;appeared pale, mildly diaphoretic;pt lightheaded; BP 98/58, P52;BP 104/70;									Y	10/29/1998	10/29/1998	0		UNK	UNK				~ ()~~~In patient		1						1	Bradycardia; Dizziness; Hyperhidrosis; Hypotension; Pallor	FLU3~CONNAUGHT LABORATORIES~0983290~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0118043	01/12/1999	MN	47.0	47		F	10/08/1998	pt recv vax 8OCT98 & BP 164/88, dry mouth, lips felt like swelling, pale, felt light headed; 7:45 164/86;remained elevated for 3 wk;									Y	10/08/1998	10/08/1998	0		UNK	UNK		NONE	on inderol for tachycardia	NONE~ ()~~~In patient		1						1	Dizziness; Dry mouth; Face oedema; Hypertension; Pallor	FLU3~CONNAUGHT LABORATORIES~0980530~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0118044	01/12/1999	MN	52.0	52		F	10/30/1998	pt recv shot w/o incident @ 8PM;devel cough immed;woke up 4AM, dizzy, nauseated & feeling of diarrhea;did not have diarrhea or vomiting;ER visit h/a in ER;devel rash on chest 30OCT;				Y					Y	10/28/1998	10/30/1998	2		OTH	PVT				~ ()~~~In patient		1						1	Condition aggravated; Cough; Diarrhoea; Dizziness; Headache; Nausea; Rash	FLU3~CONNAUGHT LABORATORIES~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0118045	01/12/1999	MN	60.0	59		F	10/10/1998	heart pounding, itching in throat, difficulty swallowing;ears itching;trembling;epi & ambulance to Er more epi;				Y					U	10/10/1998	10/10/1998	0	5JAN99 feet fine p/trip to ER;no problems since;	OTH	OTH			supraventricular tachycardia	~ ()~~~In patient		1						1	Dysphagia; Palpitations; Pharyngitis; Pruritus; Tremor	FLU3~CONNAUGHT LABORATORIES~0975800~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0118052	01/12/1999	MN	29.0	29		F	10/15/1998	difficulty breathing, shaking, heart racing, heart feeling tight, dry heaves; 210PM 110/80, p88;215PM given epi;215PM 144/92;222PM 150/92, p 100;230PM 140/80, p96;				Y					Y	10/15/1998	10/15/1998	0		OTH	OTH	Medicien for panic attacks	NONE	anxiety	~ ()~~~In patient		1						1	Chest pain; Dyspnoea; Hypertension; Tachycardia; Tremor; Vomiting	FLU3~CONNAUGHT LABORATORIES~0975800~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0118053	01/12/1999	MN	31.0			U		pt felt dizzy, lightheaded 10min p/vax;c/o difficult breathing, hyperventilating, SOB when breathing;given epi;P 120, BP 150/100;				Y										OTH	PVT				~ ()~~~In patient		1						1	Dizziness; Dyspnoea; Hypertension; Hyperventilation; Tachycardia	FLU3~CONNAUGHT LABORATORIES~E0984540~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0118054	01/12/1999	GA	44.0	44		F	12/02/1998	edema & pain started day p/vax;edema lasted 7 days, pain cont;pain starts @ inj site & goes to elbow;has severe pain when reaching out in front of body, behind body & can only reach 3/4 way above head;can not pick up objects 5lbs or more;				Y					N	10/07/1998	12/02/1998	56	going to physical therapy	PUB	UNK	Insulin	diabetes		~ ()~~~In patient	GA98133	1						1	Hypokinesia; Injection site pain; Movement disorder; Oedema; Pain	FLU3~MEDEVA PHARMA, LTD.~E20118GB~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0118058	01/12/1999	MA	51.0	51		F	11/17/1998	5cm x 6.7cm area of localized erythema, swelling, warmth & induration;no lymphadenopathy; pain & swelling 17NOV;mild erythema still present 17NOV98;									Y	10/26/1998	10/27/1998	1	NONE	PVT	UNK	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4988221~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118059	01/12/1999	PA	76.0	76		F	01/06/1999	1cm depigmentation of skin w/thinning of skin @ site of inj;									Y	10/07/1998	10/08/1998	1	NONE	PVT	PVT	pt recv MSD pneumovax lt# 0304H given 10SEP98	NONE	NONE	~ ()~~~In patient		1						1	Injection site atrophy; Injection site reaction; Skin discolouration	FLU3~CONNAUGHT LABORATORIES~0975810~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0118062	01/12/1999	FL	60.0	60		F	01/05/1999	pt recv vax 23SEP98 & myopathy/neuropathy lt arm w/overall weakness;arm was nl before onset sx;									N	09/23/1998	09/23/1998	0	NONE	PVT	PVT	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Asthenia; Myopathy; Neuropathy; Pain; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E20138GB~1~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0118064	01/12/1999	MN	13.0	13		M	10/28/1998	blurred vision, ringing in ears, sweating, faint/light headed;sat down on floor-BP 118/60, P72;BP remained stable;pt remain seated or 15-20min;									Y	10/28/1998	10/28/1998	0		OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Amblyopia; Dizziness; Hyperhidrosis; Hypertension; Tinnitus	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0118109	01/12/1999	MN	68.0	68		F	12/17/1998	pt recv vax & became violently ill 10min p/vax;26NOV98 pt exp cardiac arrest & hosp w/dx of thrombotic thrombocytopenic purpura & hemolytic uremic synd;					Y	56			U	11/07/1998	11/07/1998	0		PUB	OTH	Ibuprofen;E-vista	NONE	NONE		898352072A	1						1	Azotaemia; Cardiac arrest; Convulsion; Influenza; Malaise; Thrombocytopenic purpura	FLU3~MEDEVA PHARMA, LTD.~E20158HE~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~456692~1~IM~~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0118081	01/13/1999	OK	62.0	61		F	12/23/1998	bad cough, h/a, runny nose & eyes for 9 days started 3rd day p/shot;									Y	11/05/1998	11/08/1998	3	NONE	PUB	UNK	Glynase;Pristak, Hytrin, Tenormin		NIDDM, HTN, radiation for cervial ca MAY98 to SEP98	NONE~ ()~~~In patient	OK9853	1						1	Conjunctivitis; Cough; Headache; Rhinitis	FLU3~CONNAUGHT LABORATORIES~4988249~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0118110	01/14/1999	IN	79.0	79		F	01/12/1999	pt recv vax & exp chills, tiredness & was not feeling well the evening p/vax;on the 2nd day exp diarrhea which was stated as cont @ the time of reporting 2 days p/vax;reporter states feels flu shot somehow aggravated already present illnessAnnual follow-up received 10/02/00 provided no additional data.					Y	8			U	10/26/1998	10/31/1998	5	NONE	OTH	OTH	unk		allergies: hx of gastrointestinal sensitivity to eggs-exp diarrhea;hx of pneumonia;		MPI981970	1						1	Asthenia; Chills; Condition aggravated; Diarrhoea; Malaise; Pneumonia	FLU3~MEDEVA PHARMA, LTD.~E20238KD~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0118116	01/14/1999	FL	44.0			F	01/12/1999	pt recv vax & exp retinal edema 4-6wk p/vax;pt exp loss of vision & dilated pupils & was seen by ophthalmologist;ophthalmologist dx retinal edema;pt reports vision is getting better;MD reported adverse event has now resolved;								Y	Y	10/01/1998			NONE	OTH	OTH	unk		NONE	~ ()~~~In patient	MPI199900013	1						1	Mydriasis; Retinal oedema; Visual disturbance	FLU3~MEDEVA PHARMA, LTD.~E20168HC~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0118119	01/14/1999	CO	45.0	45		F	12/02/1998	2-3hr p/vax tongue & throat were swelling, EMS called, pt intubated;pt c/o SOB, chest pain;no local reaction noted;			Y	Y	Y				Y	11/13/1998	11/13/1998	0		OTH	UNK	azithromycin, lactase, lomotil, fiorinal, compazine	upper respiratory infection w/ rhinorrhea	migraines, lactose intolerance, hysterectomy, cholecystectomy, smoker, all:Imitrex, morphine, toradol	none~ ()~~~In patient	CO98057	1						1	Angioneurotic oedema; Chest pain; Dyspnoea; Laryngospasm; Respiratory disorder; Tongue oedema	FLU3~MEDEVA PHARMA, LTD.~E20218HA~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0118121	01/14/1999	CO	76.0	76		M	10/19/1998	pt recv vax 15OCT98 & 16OCT98 arm became red & swollen @ the  inj site;this extended into the elbow;fever 101.3;recv PCN IM & PR;wife reported husband had pneumonia vax 1998 prior to 15OCT98;				Y					Y	10/15/1998	10/16/1998	1	NA	PUB	PUB	unk	unk	unk	unk~ ()~~~In patient	CO98056	1						1	Injection site hypersensitivity; Injection site oedema; Pyrexia	FLU3~PFIZER\WYETH~4988216~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~455939~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0118122	01/14/1999	MA	1.5	1	.5	M	10/28/1998	pt recv vax & devel fever, lt hand became red & swollen & felt very painful;				Y					Y	10/05/1998			NA	PUB	PUB		ROM	NA	~ ()~~~In patient	MA9857	1						1	Oedema peripheral; Pain; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~08557~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1541E~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0118123	01/14/1999	MA	41.0	41		M	09/28/1998	pt recv vax 23SEP98 & started exp pain, swelling, low grade fever on 24SEP98;pain worsened on 26SEP98;swelling increased devel redness & red line extending from deltoid to armpit;exam revealed infect;				Y					Y	09/23/1998	09/24/1998	1		PUB	PUB				~ ()~~~In patient	MA9854	1						1	Infection; Injection site hypersensitivity; Injection site oedema; Lymphadenopathy; Oedema; Pain; Pyrexia; Skin striae	FLU3~CONNAUGHT LABORATORIES~0955780~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1541E~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|TTOX~CONNAUGHT LABORATORIES~0950740~UNK~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0118125	01/14/1999	MA	73.0	73		F	12/10/1998	1hr p/vax 30OCT98  arm red & swollen @ site;DPH given;seen @ ER arm swollen, painful;DPH given seen by MD 2NOV98;cont DPH, elevated arm stay out of work for 2 days;arm red, warm, swollen down to fingers;				Y					Y	10/30/1998	10/30/1998	0		PUB	PUB	Estrogen		allergic to codeine	~ ()~~~In patient	MA9858	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975780~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1541E~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0118126	01/14/1999	MA	71.0	71		F	10/15/1998	pt recv vax 11OCT98 & lt arm 13OCT @ noc devel pain, redness @ the site, hot to touch;no improvement as of 15OCT98;no fever;									Y	10/11/1998	10/13/1998	2		PUB	PUB	HBP med		HBP	~ ()~~~In patient	MA9853	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975780~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TTOX~CONNAUGHT LABORATORIES~0950740~2~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0118127	01/14/1999	MA	63.0	63		F	11/03/1998	6 days p/vax lt arm devel severe itchiness @ site, devel redness, swelling & hot to touch to most of area of upper arm;outer edge of area felt hard;									Y	10/23/1998	10/29/1998	6		PUB	PUB	DIuretic			~ ()~~~In patient	MA9855	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0955780~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TTOX~CONNAUGHT LABORATORIES~0950740~UNK~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0118128	01/14/1999	MA	59.0	58		F	10/27/1998	pt recv vax 21OCT98 & initially lt arm felt hard,  & sore to touch;26OCT98 observed welts, raised, red & hot;									Y	10/21/1998	10/27/1998	6		PUB	PUB				~ ()~~~In patient	MA9856	1						1	Injection site mass; Injection site pain; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0955780~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1541E~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|TTOX~CONNAUGHT LABORATORIES~0950740~UNK~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0118129	01/14/1999	MA	70.0	70		F	10/08/1998	exp w/in 24hr chills, general achiness, nausea & very sore rt arm;T100, started w/both arms being very sore, heaviness & pain;sx resolved w/in 72hr;									Y	10/07/1998	10/08/1998	1		PUB	PUB				~ ()~~~In patient	MA9859	1						1	Chills; Myalgia; Myasthenic syndrome; Nausea; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0955780~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1541E~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|TTOX~CONNAUGHT LABORATORIES~0950740~UNK~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0117062	01/19/1999	OR	59.0	59		M	12/23/1998	pt w/recent dx of GBS treated 12AUG98;pt receive vax 20OCT98;now adm for progressively worsening symptoms 10NOV98 to present;initially in ICU on ventilator now on ward w/slow resolution of sx;			Y		Y					10/20/1998	11/10/1998	21		UNK	UNK	Clonidine;Felodipine;FeSO4;Furosemide;Metolazone;Nephrocaps;Trazodone;		End stage renal disease secondary to membranous glomerular nephritis;HTN;COPD;Gastric thickening;	~ ()~~~In patient		1						2	Guillain-Barre syndrome; Hypoxia	FLU3~MEDEVA PHARMA, LTD.~E20138GB~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Life Threatening,Hospitalisation	Influenza
0118142	01/19/1999	PA	63.0			F	01/13/1999	pt recv vax & exp muscle weakness, pain in the lower extremities & chest pain;pt contacted the MD for eval the following day who observed pt walk to be unstable & c/o h/a;pt exp dysequilibrium & leg weakness;pt had excessive water drinking;Annual follow-up received 10/02/00 states that the pt has recovered.					Y				U	11/06/1998	11/11/1998	5	NONE	OTH	OTH			hx of HTN;hx of anxiety		MPI981983	1						1	Chest pain; Coordination abnormal; Headache; Hyponatraemia; Myasthenic syndrome; Pain; Personality disorder; Water intoxication	FLU3~MEDEVA PHARMA, LTD.~E20178HB~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0118154	01/19/1999	MN	79.0	79		M		pt recv vax 27OCT98 & exp 2mo of pain in neck & shoulders; now able to sleep better & thinks sx are gradually getting better but cont to have some stiffness almost everyday;										10/27/1998				UNK	UNK				~ ()~~~In patient		1						1	Hypertonia; Insomnia; Neck pain; Pain	FLU3~CONNAUGHT LABORATORIES~0978690~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~451949~UNK~~LA~PNEUMO (PNU-IMUNE)~1|TD~LEDERLE LABORATORIES~454679~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0118164	01/19/1999	ID	66.0	65		M	01/04/1999	soreness to arm x 3 days-onset day of inj;									Y	12/30/1998	12/30/1998	0	NONE	PVT	PVT	Viagra	NONE	NKDA, Hep c	NA~ ()~~~In patient		1						1	Pain	FLU3~CONNAUGHT LABORATORIES~0983330~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1339H~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0118167	01/19/1999	MS	76.0	75		M	12/21/1998	pt recv vax 27OCT98 & about week later arm started hurting lt arm;states last week was watching TV & saw show that said if you had had a flu shot & arm starts hurting afterwards to report to your provider ASAP;									U	10/27/1998	11/03/1998	7		PUB	PUB	ASA;Centrum silver dialy	NONE	NONE	~ ()~~~In patient	MS99002	1						1	Pain	FLU3~MEDEVA PHARMA, LTD.~E20158HG~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0118168	01/19/1999	CA	53.0	53		M	01/14/1999	lt shoulder pain followed by motor weakness w/in 1wk, worse in deltoid, supraspinatas and infraspinatas;also sensory loss in lateral cutaneous;nerve of forearm;weakness persists;									U	10/08/1998	11/12/1998	35	EMG supportive of lt brachial neuritis w/acut denervation;C-spine MRI & EMG not supportive of radiculopathy;	PVT	PUB	Acyclovyr, motrin, Buporpiun, prozac, entex, vancenase	NONE	genital HSV	~ ()~~~In patient		1						1	Back pain; Myasthenic syndrome; Neuritis; Pain; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E20148HA~UNK~A~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0118175	01/19/1999	NM	12.0	12		M	12/31/1998	pt recv vax 28DEC98 & w/in 6-8hr entire arm was painful & inj site was red;returned to clinic w/induration, painful lt arm, T100.3;started on keflex & Ibuprofen;erythemic,warm underarm;									U	12/28/1998	12/28/1998	0		UNK	PUB	Atendol	URI	NKDA-cardiomyopathy	NA~ ()~~~In patient	NM98023	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4988216~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~454378~1~SC~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0118178	01/19/1999	CO	40.0	40		F	12/11/1998	10:15 inj lt deltoid;10:30 localized rash @ inj site, DPH;10:45 inc rash, wheels lt arm, DPH;11:00 rash resolving;									Y	10/21/1998	10/21/1998	0		OTH	PUB	NONE	NONE	skin allergies various irritants	~ ()~~~In patient	CO98062	1						1	Injection site hypersensitivity	FLU3~MEDEVA PHARMA, LTD.~E20228KC~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0118200	01/20/1999	NY	54.0	54		F	01/11/1999	pt dx w/mild case of GBS; Annual follow-up dated 10/12/00 provided no additional data.					Y	7			N	11/05/1998	11/24/1998	19		UNK	UNK	NONE	NONE	NONE			1						1	Guillain-Barre syndrome	FLU3~PFIZER\WYETH~4988212~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0118202	01/20/1999	WA	58.0	57		M	11/16/1998	low grade fever 1wk p/vax;by 31OCT98 had mild gait instability which progressed hosp  6NOV98 @ hosp;dec reflexes, weakness of extremities, painful tingling;dx GBS has had 5 plasma exchange;			Y	Y	Y	67			N	10/08/1998	10/15/1998	7	CSF protein 80 (increased);MEG studies;	OTH	UNK	NONE	NONE	NONE		WA981522	1						1	CSF test abnormal; Gait disturbance; Guillain-Barre syndrome; Hyporeflexia; Myasthenic syndrome; Pain; Paraesthesia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0965840~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0118211	01/20/1999	WA	66.0	66		F	11/30/1998	Pt recv vax on 10/5/98; on same day pt exp pain, swelling of vax site then to shoulder, arm, wrist, hand; tight throat, left neck & left buttock pain; unable to move left arm; tx=Methylprednisolone (pt didn't take)				Y					U	10/05/1998	10/05/1998	0	NONE	PUB	OTH	NONE	NONE	Mental breakdown '87, on meds x 2 yr; Allergic to Novacaine-local pain & swelling	NONE~ ()~~~In patient	WA981518	1						1	Arthropathy; Bursitis; Chest pain; Dry skin; Ear pain; Ecchymosis; Headache; Hypokinesia; Injection site mass; Injection site oedema; Injection site pain; Insomnia; Laryngospasm; Lymphadenopathy; Movement disorder; Neck pain; Nuchal rigidity; Oedema peripheral; Pain; Paraesthesia; Pharyngitis; Vasodilatation	FLU3~PFIZER\WYETH~4988200~4~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~444077~2~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0118214	01/20/1999	WA	44.0	44		F	10/28/1998	Pt recv vax on 10/22/98; on same day pt exp LA pain from shoulder to hand									U	10/22/1998	10/22/1998	0	UNK	PUB	PUB	Premarin	UNK	UNK	UNK~ ()~~~In patient	WA981521	1						1	Hypokinesia; Myalgia; Pain	FLU3~PFIZER\WYETH~4988200~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0117996	01/21/1999	MD	6.0	6		F	12/28/1998	8DEC98 pt recv vax & 10DEC98 pt was adm to hosp w/dx of GBS;GBS sx began 2wk prior to vax administration;					Y				Y	12/08/1998	12/08/1998	0		UNK	UNK	NONE	NONE	NONE			1						2	Condition aggravated; Guillain-Barre syndrome; Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~0984570~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0984570~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0118224	01/21/1999	SC	52.0	52		F	12/03/1998	Pt recv vax on 11/17/98; 12 hr post vax pt exp shoulder pain/ itching/ swelling to elbow x 2 wk, fever ; tx=Tylenol, ice pack & Allegra				Y					Y	11/17/1998	11/17/1998	0	NONE	PUB	PUB	Arthrotec, Cinobac, Urised, Premarin, Halcion, Pepcid,  Bentyl, Xanax	Cystitis, Arthritis	Multiple environmental allergies	NONE~ ()~~~In patient	SC98085	1						1	Hypertension; Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Oedema peripheral; Pain; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~978670~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~970520~2~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0118225	01/21/1999	SC	68.0	68		M	10/30/1998	Pt recv vax on 10/29/98; on same day pt exp red swelling of Rt arm w/ pain; 10/30 pt exp hotness at vax site to forearm; dx=allergic rx; tx=hot & cold packs, Ceclor; pt imp 11/4/98				Y					Y	10/29/1998	10/29/1998	0	UNK	PUB	PUB	NONE	NONE	NONE	UNK~ ()~~~In patient	SC98073	1						1	Hypersensitivity; Injection site hypersensitivity; Injection site oedema; Insomnia; Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0980580~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1094H~1~SC~RA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~0963390~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0118231	01/21/1999	SC	22.0	22		F	11/17/1998	Pt recv vax on 11/2/98; on 11/3/98 pt exp inflamed area of LA, fever (101), nausea, body aches; dx=allergic rx to pneumonia vax				Y					Y	11/02/1998	11/03/1998	1	NONE	PUB	PUB	Accolate, Rhinocort, Tilade, Serevent Inhaler\	NONE	Asthma, Allergic to pollen, dust, grasses, trees, smoke, animal dander	UNK~ ()~~~In patient	SC98080	1						1	Hypersensitivity; Injection site inflammation; Myalgia; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0983300~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1094H~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0118232	01/21/1999	SC	51.0	51		F	11/23/1998	pt called 17NOV98 & c/o lt arm soreness/pain that kept getting worse on Wednesday p/vax;c/o welts w/itching from shoulder down to elbow;SOB 1st couple of days-went to ER on Sunday afternoon 15NOV98;lt arm sore;				Y					Y	11/09/1998	11/11/1998	2	NA	PUB	UNK			heart problems	~ ()~~~In patient	SC98090	1						1	Dyspnoea; Injection site hypersensitivity; Myalgia; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~0984550~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1094H~UNK~~LA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~0963390~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0118237	01/21/1999	AZ	26.0	25		F	11/09/1998	Pt recv vax on 11/4/98; on 11/5/98 pt exp cramping, burning, pain on rt arm to shoulder									N	11/04/1998	11/05/1998	1	NONE	PUB	OTH	UNK	NONE	NONE	UNK~ ()~~~In patient	AZ9902	1						1	Injection site pain; Pain	FLU3~PFIZER\WYETH~4988199~2~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118255	01/21/1999	MA	72.0	72		F	10/09/1998	Pt recv vax on 11/8/97; in 3/98 pt exp numbness & tingling in lower extremities; dx=idiopathic peripheral neuropathy				Y					N	11/18/1997	03/01/1998	103	9/3/98:  EMG & nerve conduction studies-results not provided	PVT	OTH	Hydrochlorothiazide daily, Lisinopril, Ibuprofen	NONE	Hypertension & osteoarthritis	NONE~ ()~~~In patient	898286019A	1						1	Neuropathy; Paraesthesia; Neuropathy peripheral; Paraesthesia	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0118256	01/21/1999	CA	75.0			F	10/20/1998	Pt recv vax on unknown day;1 wk post vax pt exp tendinitis in Rt arm; tx=ice, heat & physical therapy w/ out relief				Y					U				UNK	OTH	OTH	NONE	UNK	Allergic to mushrooms	UNK~ ()~~~In patient	898306002L	1						1	Tendon disorder; Pain	FLU3~PFIZER\WYETH~4978179~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0118257	01/21/1999	CO	22.0			F	11/06/1998	Pt recv vax on unknown day; post vax pt exp rash									Y				UNK	OTH	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient	898317014L	1						1	Rash	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118258	01/21/1999	PA				F	11/12/1998	Pt recv vax on unknown day; post vax pt exp vax site induration, erythema & itching from shoulder to elbow; pt imp 3 wk									Y				UNK	PVT	PVT	UNK	UNK	UNK	UNK~ ()~~~In patient	898337002L	1						1	Injection site hypersensitivity; Injection site mass; Pruritus	FLU3~PFIZER\WYETH~~1~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118259	01/21/1999	NY	72.0	72		F	10/21/1998	Pt recv vax on 10/15/96; on 10/17/96 pt exp fever (100 -102F)									Y	10/15/1996	10/17/1996	2	UNK	OTH	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient	898300102A	1						1	Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118277	01/22/1999	TX	51.0	51		F	11/24/1998	Pt recv vax on 11/23/98; on same day pt exp raised, red, edematous, warm area of LA; vax supposed to be given IM									Y	11/23/1998	11/23/1998	0	Aplisol test supposed to be given	PVT	PVT	Premarin, Diazide, Doltarin, Lotensin, Plaquevin, Colchicine	NONE	Rheumatoid arthritis, High blood pressure	UNK~ ()~~~In patient	FLU90231198	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~00408P~1~SC~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0118278	01/22/1999	NJ	46.0			F	12/10/1998	Pt recv vax on unknown day; post vax pt exp pain in shoulder, neck to ear, chills, aching, sore throat & swollen glands; pain w/ arm raised X 5 wk									Y				NONE	PVT	PVT	Zantac	NONE	Allergic to Sulfa drugs	NONE~ ()~~~In patient	FLU92151298	1						1	Arthralgia; Chills; Ear pain; Lymphadenopathy; Myalgia; Neck pain; Pharyngitis	FLU3~PARKDALE PHARMACEUTICALS~~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0118279	01/22/1999	TX	41.0	41		F	11/24/1998	Pt recv vax on 11/23/98; on same day pt exp red, edematous, raised area, rash over body, shortness of breath  x 24 hr; vax given SC									Y	11/23/1998	11/23/1998	0	Supposed to give Aplisol injection	PVT	PVT	Norvasc, Zytrec, Aspirin	UNK	High blood pressure, Allergic to eggs & milk	NONE~ ()~~~In patient	FLU90241198	1						1	Dyspnoea; Injection site hypersensitivity; Injection site mass; Injection site oedema; Rash	FLU3~PARKDALE PHARMACEUTICALS~OO4O8P~1~SC~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0118282	01/22/1999	VT	48.0	48		M	12/12/1998	pt reported a month p/vax has been sick w/diarrhea, nausea & h/a since inj;has not seen a MD;states there as few other @ office who were sick;encouraged pt to see MD;				Y					U	11/05/1998			unk	OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Diarrhoea; Headache; Nausea	FLU3~CONNAUGHT LABORATORIES~0984550~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0118288	01/22/1999	NY	65.0	65		F	12/19/1998	pt recv vax 7OCT98 & 9OCT98 c/o rash & pain in lt arm to elbow;no warmth to touch;no swelling;rash spread to other arm;										10/07/1998	10/07/1998	0		UNK	UNK	NONE			~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Rash	FLUX~UNKNOWN MANUFACTURER~0978660~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0118296	01/22/1999	PA	80.0	80		F	01/06/1999	Pt recv vax on 10/27/98; on 11/6/98 pt exp clonic seizure x 5 min- blowing respirations, eyes fixed; tx=bed rest for that night									Y	10/27/1998	11/06/1998	10	Temp 98.0; BP 130/72; Pulse 112, Resp 24; Calcium 9.7, Sodium 140, K 4.3, Chloride 105, Glucose 122, BUN 31, Creatinine 1.4, HCT 35.5%	OTH	PVT	Acetaminophen, Docusate, Metoprolol, Oystershell calcium, Sienna concentrate, Sorbitol, Synthroid, Vit E, Codeine, Bisacodyl	NONE	Allergic to Sulfa	NONE~ ()~~~In patient		1						1	Anaemia; Blood urea increased; Convulsion; Hyperglycaemia; Hypertension; Hyperventilation; Hypothermia; Stupor	FLU3~MEDEVA PHARMA, LTD.~2023AKB~UNK~~GM~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0118302	01/25/1999	OH	51.0	51		F	01/05/1999	transverse myelitis;onset of weakness in rt lower extremity on 20NOV98, peaking by 21NOV-22NOV, then improving;milder sx in lt lower extremity clonus at both ankles;				Y					Y	11/13/1998	11/20/1998	7	cerebrospinal fluid analysis of MIR of C-spine	OTH	OTH		unk	unk	~ ()~~~In patient		1						1	Hypertonia; Myasthenic syndrome; Myelitis	FLUX~UNKNOWN MANUFACTURER~02888P~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0118308	01/25/1999	NY	60.0	60		F	11/25/1998	PM 17NOV98 devel drooping mouth especially lt side but this did also appear on rt @ times;rt eye affected also weak dx as Bell's Palsy viral infect;tx w/pred, eye gtts;MD does not feel this is vaccine related;				Y					N	11/14/1998	11/17/1998	3	MRI, Lyme disease test both negative;	PUB	PUB	Diazide	HTN	NONE	NA~ ()~~~In patient	NY98037	1						1	Facial palsy; Infection; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~0968410~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0118325	01/25/1999	NY	51.0	51		F	11/20/1998	dry cough, low grade fever, h/a, backache, conjunctivitis;									Y	11/18/1998	11/18/1998	0		PUB	PUB	minocycline	NA	allergy PCn, rosacea	pt exp bodyache, congestion, sore throat @ age 40 w/flu 1st dose;~ ()~~~In patient	NY98036	1						1	Back pain; Conjunctivitis; Cough; Headache; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0984570~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0118329	01/26/1999	CA	86.0	86		F	01/20/1999	pt exp onset of lower extremity weakness;pt could hardly walk around;very weak;balance is not good;BP 172/80;wide base gait that is unsteady;edema in ankles;possible GBS;Annual follow-up dated 10/4/00 provided no additional data.								Y	N	11/04/1998	11/05/1998	1		PVT	PVT	dyazide, premarin,ibuprofen	None	edema ankles, allergic codeine, episodes of weakness since 8/98			1						1	Coordination abnormal; Guillain-Barre syndrome; Hypertension; Hypokinesia; Myasthenic syndrome; Oedema peripheral	FLU3~PARKDALE PHARMACEUTICALS~02198P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Disabling	Influenza
0118419	01/29/1999	NY	55.0	54		F	11/18/1998	pt had vax 2wk ago (around late October) & devel GBS, numbness, tingling sensation in  B/L LE & UE, generalized weakness, diff ambulating, tachycardia, pt adm to hosp;dx GBS			Y		Y	11			N	10/30/1998	11/13/1998	14	EMG-demyelinating sensorimotor polyneuropathy typical of GBS	UNK	UNK	Viracept, Vasotec, Gabapentin, Sustiva, Leucovorin, Pyramethamine;	None	HIV	~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome; Hypokinesia; Paraesthesia; Tachycardia	FLU3~PFIZER\WYETH~4988221~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0118422	01/29/1999	FL	63.0	63		M	01/27/1999	flu like sx x 7 day, chills, fever, joints attacked/painful, no strength especially knees, wrist, hand-pain moves from one joint to another;Annual follow-up dated 10/10/00 states that symptoms progressed into Wegeners Granulamatosis.			Y	Y	Y	9			N	11/23/1998	11/25/1998	2	CH50-243;all levels elevated;platelet 433, protein 8.6, bilirubin pho 127, potassium 5.4, westergrin 37-129;	PUB	PUB	NONE	sinus infect	NONE			1						1	Anaemia; Arthralgia; Blood alkaline phosphatase increased; Blood creatinine increased; Blood urea increased; Chills; Granuloma; Hyperbilirubinaemia; Hyperglycaemia; Hyperkalaemia; Hypokinesia; Influenza; Laboratory test abnormal; Leukocytosis; Pain; Protein bound iodine increased; Pyrexia; Red blood cell sedimentation rate increased; Renal failure; Thrombocythaemia; Arthralgia; Asthenia; Chills; Diarrhoea; Granuloma; Influenza; Laboratory test abnormal; Oral candidiasis; Pyrexia; Red blood cell sedimentation rate increased; Thrombocythaemia	FLU3~MEDEVA PHARMA, LTD.~E201584A~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1173E~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~MEDEVA PHARMA, LTD.~E201584A~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~1173E~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Life Threatening,Hospitalisation	Influenza
0118424	01/29/1999	MI	35.0	35		F	12/23/1998	27OCT98 sl fever (also all 4 kids sick, two w/croup);29OCT98 lost voice;1NOV98 to urgent care w/h/a ? poss sinus infect or bronchitis;arm & leg pain, neck & head pain;cough;fever 103-104;5NOV98 disoriented d/t dehydration;rash;tight chest;				Y					Y	10/26/1998	10/27/1998	1	lab work drawn @ hosp-lab work back MD thinks viral pneumonia;	PUB	PVT	Birth control pills;Flonase PRn	felt tired before vax	ragweed, pollen, dust-occ wheeze w/doogs;PUPS w/twins	NONE~ ()~~~In patient	MI99002	1						1	Asthenia; Bronchitis; Cardiovascular disorder; Chest pain; Confusional state; Dehydration; Headache; Infection; Laryngitis; Malaise; Pain; Pneumonia; Pruritus; Pyrexia; Rash; Sinusitis	FLU3~PFIZER\WYETH~4988204~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0118433	01/29/1999	MI	49.0	49		F	01/08/1999	approx 24-36hr post vax exp rash on lower arms & legs;pt stated they were red raised bumps caused itching;no other sx devel;rash lasted approx 2 days;									Y	11/19/1998			NONE	PUB	PUB	Synthroid	NONE	allerg PCN, dust, mold, mildew & cats	NONE~ ()~~~In patient	MI99004	1						1	Pruritus; Rash; Rash maculo-papular	FLU3~PFIZER\WYETH~4988204~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118447	01/29/1999	FL	52.0			U		pt recv flu vax & MD realized this was last yr vax & pt given flu shot again w/in 4 days of the first one;pt states has been extremely ill w/flu type sx;MD called CDC for advice told to give 2nd shot this years flu vax would not effect last										10/30/1998				UNK	UNK			diabetic;	~ ()~~~In patient		1						1	Influenza	FLU3~MEDEVA PHARMA, LTD.~E20248KA~2~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0118451	02/01/1999	MN	43.0	43		F	01/15/1999	24hr p/vax devel temp of 103 x 2-3 days;also had sx muscle achiness, general fatigue, runny nose;had low grade fever x7 days;devel productive cough dx w/pneumonia;PMD recommended report this as adverse reaction to flu vax;				Y					N	10/13/1998	10/14/1998	1	blood work-inc WBC p/10 days, CXR	PVT	PVT	Axocety;Zomig PRN;Inderal	NONE	migraine h/a;	pt mom & aunts exp muscle aches, fatigue from early 50's w/flu vax;~ ()~~~In patient		1						1	Asthenia; Cough; Myalgia; Pneumonia; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0984590~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0118502	02/02/1999	IA	78.0	78		F		adm w/flu-like sx flu shot 9 days earlier;pt w/underlying COPD went on to devel pneumonia & renal failure & resp failure, died 5NOV;	Y	11/05/1998			Y				N	10/15/1998	10/24/1998	9		UNK	UNK			COPD, IDDM, Smoker, Aspiration pnuemonia, depression, thyroid			1						1	Apnoea; Condition aggravated; Influenza; Lung disorder; Pneumonia; Pneumonia aspiration; Renal failure	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0118543	02/04/1999	NY	34.0	34		M	01/22/1999	Pt recv vax on 10/28/98; on 11/19/98 pt exp nervousness & shakes				Y					N	10/28/1998	11/19/1998	22	WBC - 12/15/98: 3.4	OTH	PUB	Proventil inhaler, Lidex cream/ Lachydro	UNK	Allergic to Penicillin	UNK~ ()~~~In patient		1						1	Leukopenia; Nervousness; Tremor; Anxiety; Leukopenia; Tremor	FLU3~PFIZER\WYETH~4988212~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4988212~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0118552	02/04/1999		90.0	90		F	12/21/1998	Pt recv vax on 10/23/98; on same day pt exp local rx of red, tender, swelling, sore; trouble sleeping; tx=ice, moist heat, Darvocet				Y					U	10/23/1998	10/23/1998	0	Blood pressure 150/80	OTH	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Insomnia; Oedema peripheral; Pain	FLUX~UNKNOWN MANUFACTURER~02198P~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0118565	02/05/1999		70.0			M	01/29/1999	Pt recv vax on 1/14/99; on same day pt exp hypoglycemia x 12 hr; tx=glucose			Y		Y					01/14/1999	01/14/1999	0	NONE	OTH	OTH	UNK	UNK	NONE	UNK~ ()~~~In patient	DIS199900044B	1						1	Hypoglycaemia	FLU3~MEDEVA PHARMA, LTD.~BE81020AA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0118572	02/05/1999	CA	55.0	55		M		noted inj site pain starting 3 days p/vax by 4th day pain was severe;itching 1st symptom 1wk p/inj noted feeling weakness, pain less but still considerable;pain relieved by Ibuprofen;gen weakness w/sore muscles;c/o shaky 2FEB99;									N	10/28/1998	10/31/1998	3	7JAN99 Glob 3.6 (SEP WNL)-WBC 13.8, neutrophil 10K;ESR 11;CRP 0.8 elevated 23JAn99 CPK;	PUB	PUB	NONE	NONE	hx 2FEB92 suggest reactive hypeoglycemia (provisional) RBC Mg 2.8 low) CPK 82 nl;	~ ()~~~In patient		1						1	Asthenia; Infection; Injection site hypersensitivity; Injection site pain; Leukocytosis; Myalgia; Pruritus	FLU3~MEDEVA PHARMA, LTD.~E20138HB~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0118595	02/08/1999	FL	52.0	52		M	02/02/1999	c/o  swelling of lt upper arm (lymph node);pt spoke w/MD & said it might be related;pt got better as the day went on;				Y					Y	10/14/1998	10/15/1998	1	NONE	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Lymphadenopathy; Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~0977180~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0118596	02/08/1999	FL	42.0	42		F	11/04/1998	pt c/o 3 big raised wheals (rt arm) very painful w/o touching, unable to move arm since 6PM 8OCT98;c/o achiness & fever;pt told to go to ER if persist;pt went to ER & was given decadron & was sent home & was better a few days later;				Y	Y				Y	10/08/1998	10/08/1998	0	NONE	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Hypokinesia; Myalgia; Pain; Pyrexia; Urticaria	FLU3~CONNAUGHT LABORATORIES~0977180~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0305H~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0118615	02/08/1999	MA	77.0	77		M	11/16/1998	Pt recv vax on 10/14/98; on 10/24/98 pt exp aches & pains all over body w/ groin pain, frequent urination, not sleeping									U	10/14/1998	10/24/1998	10	UNK	PUB	PUB	NONE	NONE	UNK	UNK~ ()~~~In patient	MA9903	1						1	Insomnia; Myalgia; Pelvic pain; Pollakiuria	FLU3~CONNAUGHT LABORATORIES~0975790~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0118620	02/08/1999	FL	55.0	55		F	02/02/1999	Pt recv vax on 10/21/98; on same day pt exp aching all over, cough & sore throat; on 10/23/99 pt exp fever (102)									Y	10/21/1998	10/21/1998	0	NONE	OTH	OTH	UNK	NONE	NONE	NONE~ ()~~~In patient		1						1	Cough; Myalgia; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0978660~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0118630	02/09/1999		63.0	63		M	02/05/1999	Pt recv vax on 10/22/98; a few hours post vax pt exp acute onset left sided sensorineural hearing loss, Annual follow-up received on 10/2/00 provided no additional data.					Y			Y	N	10/22/1998	10/22/1998	0	CT brain/MRI scan-negative, Blood tests-normal	OTH	OTH	Glucophage, Capoten, Deltacotril, Clarityn	NONE	Diabetes mellitus, Hypertension & Cystosarcoma phyllodes; Right sided hearing loss		MPU199900047	1						1	Deafness	FLU3~MEDEVA PHARMA, LTD.~E8102EA1~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0118676	02/09/1999	CA	34.0	34		F	10/28/1998	site of flu vax red & warm;redness measures 4.6cm x 6cm;mild soreness @ site;noticed it all the next morning @ 715AM;c/o itchy inside also;29OCT98 no redness & no warmth;				Y					Y	10/27/1998	10/28/1998	1	NONe	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0984620~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0118678	02/09/1999	FL	11.0	10		M	12/23/1998	pt recv vax 22DEC98 4PM was tense & c/o dizziness just p/vax;had a tender abd; later devel severe h/a;rt upper arm became painful;AM rt cheek was swollen, pain rt arm cont;rt perioral area swollen;extreme dysesthesia;peripheral neuropathy;				Y					U	12/22/1998	12/22/1998	0	NONE	PVT	PUB				NA~ ()~~~In patient		1						1	Abdominal pain; Arthropathy; Dizziness; Face oedema; Headache; Injection site pain; Nervousness; Neuropathy; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0978670~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SMITHKLINE BEECHAM~2710A2~2~IM~LA~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0118683	02/09/1999	MO	31.0	31		M	01/12/1999	Pt recv vax on 10/26/98; on same day pt exp throat swelling, itchy blotches of rash on body, puffy eyes & headache;dx=allergic rx; tx=steroids				Y					Y	10/26/1998	10/26/1998	0	UNK	OTH	PVT	NONE	NONE	Allergies	UNK~ ()~~~In patient		1						1	Face oedema; Hypersensitivity; Laryngospasm; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~0973970~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0118692	02/09/1999	WI	44.0	44		F	01/14/1999	pt recv vax 12NOV98 & reported that pt went to ER @ 3PM that day for treatment;in ER MD treated pt w/the dx of acute allergic rxn;c/o heaviness in chest, diff breathing & soreness in lt arm;tx IV solumedrol, DPH, tagamet;				Y					Y	11/12/1998	11/12/1998	0	EKG done	OTH	OTH	NONE	NONE	unk	~ ()~~~In patient		1						1	Chest pain; Dyspnoea; Hypersensitivity; Pain	FLU3~CONNAUGHT LABORATORIES~0984540~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0118710	02/09/1999	CT	57.0	57		F	02/02/1999	pt recv c/o of chest tightness, face became flushed, stated had thickened feeling in throat; recv epi & transported via ambulance to hosp;recv pred, DPH, pepcid;				Y					Y	01/27/1998	10/27/1998	273	NA	OTH	OTH	Norvasc	NONE	NONE	~ ()~~~In patient		1						1	Chest pain; Laryngospasm; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0983320~1~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0118721	02/09/1999	WA	46.0	46		F	02/01/1999	Pt recv vax on 1/8/99; 1 hr post vax pt exp joint swelling, edema of hands & face, nausea				Y					Y	01/08/1999	01/08/1999	0	ANA-(weak speckled pattern), rheumatoid factor-negative, 1/24: CBC-normal, Sedrate 24	PVT	PVT	UNK	NONE	Allergic to Macrodentin, Sulfa, Benovel, Indocin, Fledene, Robosin, Dizocillin, HepB vax-arthralgia	Pt recv Hep B #1; exp arthralgia~ ()~~~In patient		1						1	Antinuclear antibody; Nausea; Oedema peripheral; Osteoarthritis; Red blood cell sedimentation rate increased	FLU3~PFIZER\WYETH~4988201~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~SMITHKLINE BEECHAM~2795A2~2~IM~RA~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0118725	02/09/1999	IA	67.0	67		F	01/25/1999	Pt recv vax on 10/22/98; on 10/24/98 pt exp joint aches (elbow, shoulder, hip)				Y					N	10/22/1998	10/24/1998	2	UNK	OTH	PVT	NONE	NONE		UNK~ ()~~~In patient		1						1	Arthralgia	FLU3~PFIZER\WYETH~0975820~1~A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0118728	02/09/1999	CO	44.0	44		M	12/09/1998	Pt recv vax on 12/2/98; on 12/5/98 pt exp pain when lifting LA, tricep area swollen, red, hot; tx=ice & Ibuprofen				Y					U	12/02/1998	12/05/1998	3	UNK	MIL	MIL	UNK	NONE	NONE	UNK~ ()~~~In patient		1						1	Hypokinesia; Oedema peripheral; Pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0118731	02/09/1999	HI	3.0	3		M	01/25/1999	Pt recv vax on 1/20/99; on 1/21/99 pt exp urticarial rash; tx=Benadryl				Y					Y	01/20/1999	01/21/1999	1	NONE	PUB	PUB	UNK	Viral gastroenteritis	Reactive airway disease, Microcephaly	UNK~ ()~~~In patient	HI9902	1						1	Injection site hypersensitivity; Urticaria	FLU3~CONNAUGHT LABORATORIES~0984560~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0118738	02/09/1999	CA	55.0	55		F	02/02/1999	Pt recv vax beginning of  11/98; at the end of 11/98 pt exp Bell's Palsy				Y					Y	11/01/1998	11/01/1998	0	NONE	PVT	PVT	NONE	NONE	Allergies	Pt sister recv flu vax 11/98; exp Bell's Palsy 11/98~ ()~~~In Sibling		1						1	Facial palsy	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0118751	02/09/1999	SC	59.0	59		F	01/20/1999	syncopal episode;c/o nausea, lower extremity, weakness & generalized achiness 2hr p/vax;vitals @ time of syncopal episode BP 90/50, HR 50;p/ 750cc nl saline BP 128/70, HR 80;									Y	12/16/1998	12/16/1998	0	EKG nl sinus rhythm	PVT	PVT	Combipatch	NONE	NONE	~ ()~~~In patient		1						1	Bradycardia; Hypotension; Myalgia; Myasthenic syndrome; Nausea; Syncope	FLU3~CONNAUGHT LABORATORIES~0981820~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1247H~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0118777	02/09/1999	MD	26.0	26		M	01/16/1999	pt devel generalized urticaria 24hr p/vax;hives resolved over next 3 days w/DPH;pt did devel URI sx shortly p/developing hives;pt currently hive free;no other systemic sx x/URI;no other meds;									Y	01/15/1999	01/16/1999	1	NONE	MIL	MIL	NONE	devel URI (head cold)24hr p/vax	NONE	~ ()~~~In patient		1						1	Pharyngitis; Urticaria	ANTH~MICHIGAN DEPT PUB HLTH~FAV017~UNK~SC~LA~ANTHRAX (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4988248~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEPA~MERCK & CO. INC.~0122H~UNK~IM~LA~HEP A (VAQTA)~1|JEV~CONNAUGHT LABORATORIES~EJN+163A~UNK~SC~RA~JAPANESE ENCEPHALITIS (J-VAX)~1|TYP~CONNAUGHT LABORATORIES~PO323~UNK~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0118778	02/09/1999	NE				F	01/19/1999	pt recv vax later next day became sick (malaise, fatigue) did not come to work;									Y	10/02/1998	10/03/1998	1	NONE	PUB	OTH	unk	unk	unk	unk~ ()~~~In patient		1						1	Asthenia; Malaise	FLU3~CONNAUGHT LABORATORIES~0981800~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0118804	02/09/1999	CA	40.0	40		F	01/19/1999	Pt recv vax on 10/26/98; 12 hr post vax pt exp headache, diarrhea & achiness x 12 hr									Y	10/26/1998	10/26/1998	0	NONE	PVT	PVT	NONE	NONE	Migraine headaches	UNK~ ()~~~In patient		1						1	Diarrhoea; Headache; Myalgia	FLU3~CONNAUGHT LABORATORIES~0984620~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0118805	02/09/1999	CA	52.0	52		F	01/20/1999	Pt recv vax on 10/27/98; on 10/28/98 pt exp red, swollen, warm vax site w/ firmness; pt imp 11/3/98									Y	10/27/1998	10/28/1998	1	NONE	PVT	PVT	Loestrin	NONE	Hypertension	UNK~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0984620~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0118806	02/09/1999	CA	43.0	42		F	01/20/1999	Pt recv vax on 10/28/98; 2 hr post vax pt exp red, warm vax site; pt imp 11/2/98									Y	10/28/1998	10/28/1998	0	NONE	PVT	PVT	NONE	NONE	NONE	UNK~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0984620~5~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0118807	02/09/1999	CA	38.0	38		F	01/20/1999	Pt recv vax on 11/3/98; on same day pt exp red, swelling, sore, warm vax site; pt imp 11/7/98									Y	11/03/1998	11/03/1998	0	NONE	PVT	PVT	NONE	NONE	NONE	UNK~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0984620~4~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0118808	02/09/1999	TX	40.0			F	01/19/1999	pronounced erythema around site, radiating into shoulder & neck;itching of throat & neck;tx w/DPH rxn resolved w/in 60min;									Y	10/23/1998	10/23/1998	0	NA	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pharyngitis; Pruritus; Rash	FLU3~PFIZER\WYETH~E20278KA~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118811	02/09/1999	UT	48.0	48		F	12/31/1998	body aches-hands, arms, legs;vomiting 5hr;onset w/in4hr duration 12hr;									Y	11/04/1998	11/04/1998	0	NONE	OTH	PUB		NONE	NONE	pt exp rxn @ 46yr old w/flu vax;~ ()~~~In patient		1						1	Myalgia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~7+~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0118813	02/09/1999	MD	32.0	32		F	01/11/1999	the day deltoid area was sore;the next day pain traveled to anterior shoulder joint pain would wake up noc;shoulder pain (bursitis) has cont although is gradually improving;									U	10/19/1998	10/20/1998	1	NONE	PVT	PVT	NA	NA	allergies PCn, sulfa, tetracycline & environmental			1						1	Bursitis; Insomnia; Pain	FLU3~PFIZER\WYETH~E211686A~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118819	02/09/1999	NE				F	01/19/1999	pt recv vax later that day pt devel SOB & cough, malaise, fever, body ache;OK next day;									Y	10/06/1998	10/06/1998	0	NONE	PUB	OTH	unk	NONE	UNK	unk~ ()~~~In patient		1						1	Cough; Dyspnoea; Malaise; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0981800~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0118822	02/09/1999	NE				U		pt recv vax & later that evening pt devel SOB, cough, chest burning w/flu like sx, achy joints, chilling;no fever-resolved in 24hr;									Y	10/12/1998	10/12/1998	0	NONE	PUB	OTH	unk	unk	unk	unk~ ()~~~In patient		1						1	Arthralgia; Chest pain; Chills; Cough; Dyspnoea; Influenza	FLU3~CONNAUGHT LABORATORIES~0981800~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0118826	02/09/1999	KY	49.0	49		M	01/19/1999	Pt recv vax on 11/5/98; on 11/6/98 pt exp raised, red, itchy welts over body x 1 mon									Y	11/05/1998	11/06/1998	1	NONE	PUB	PUB	Norvasc, Hytrin	NONE	Hypertension, Hx of radical prostatectomy	NONE~ ()~~~In patient		1						1	Urticaria; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~021198P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0118828	02/09/1999	WA	48.0	48		F	01/11/1999	Pt recv vax on 12/9/98; on same day pt exp red neck & face w/ itching of head & arms, thick mucus, swollen upper arm w/ pain; tx=Benadryl									Y	12/09/1998	12/09/1998	0	UNK	OTH	OTH	NONE	NONE	Allergic to anesthesia	NONE~ ()~~~In patient		1						1	Oedema peripheral; Pain; Pruritus; Rhinitis; Vasodilatation	FLU3~PFIZER\WYETH~4988201~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118860	02/09/1999	NE	34.0	34		F	01/19/1999	Pt recv vax on 10/21/98; 4 hr post vax pt exp tight chest, cough, fatigue & body aches									Y	10/21/1998	10/21/1998	0	NONE	PUB	OTH	UNK	NONE	UNK	UNK~ ()~~~In patient		1						1	Asthenia; Chest pain; Cough; Myalgia	FLU3~CONNAUGHT LABORATORIES~0981800~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0118863	02/09/1999	AL	28.0	28		F	01/27/1999	Pt recv vax on 1/8/99; on 1/9/99 pt exp sore throat x 2wk, chills, aches, pain, fever, raw/scratchy feeling in chest, difficulty swallowing									Y	01/08/1999	01/09/1999	1	UNK	PUB	PVT	Triphasil birth control pills	NONE	NONE	NONE~ ()~~~In patient		1						1	Chest pain; Dysphagia; Myalgia; Pharyngitis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~4~~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0119073	02/09/1999	CA	55.0	55		F	02/02/1999	pt recv flu vax & sometime beginning of NOV98 contracted bell's palsy end of NOV98;									Y	11/01/1998	11/01/1998	0	NONE	PVT	PVT	NONE	NONE		pt sibling devel Bell's palsey NOV98 p/flu vax~ ()~~~In Sibling		1						1	Facial palsy	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0105837	02/10/1999	NY	50.0			F	12/01/1997	Pt recv vax on 11/5/97; on same day pt exp swelling at vax site									Y	11/05/1997	11/05/1997	0	UNK	OTH	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient		1						2	Injection site oedema	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0118849	02/10/1999	WA	71.0	70		F	02/05/1999	Pt recv vax on 12/21/98; on same day pt exp fever, nausea, pain & fainting									Y	12/21/1998	12/21/1998	0	Blood test	PUB	PUB	TB skin test on 12/21/98; Pain medication from dentist	NONE	NONE	NONE~ ()~~~In patient		1						1	Nausea; Pain; Pyrexia; Syncope	FLU3~PFIZER\WYETH~4988200~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1508E~1~SC~LA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~0934600~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0116122	02/11/1999	HI	51.0	50		F	11/02/1998	Pt recv vax on 10/22/98; on same day pt exp local inflammation				Y					Y	10/22/1998	10/22/1998	0	NONE	PVT	PVT	UNK	NONE	NONE	NONE~ ()~~~In patient	FLU89221198	1						2	Injection site hypersensitivity; Injection site inflammation	FLU3~PARKDALE PHARMACEUTICALS~02988P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0116123	02/11/1999	HI	68.0	68		F	11/02/1998	Pt recv vax on 10/20/98; on same day pt exp local inflammation & erythema				Y					Y	10/20/1998	10/20/1998	0	NONE	PVT	PVT	UNK	UNK	UNK	NONE~ ()~~~In patient	FLU89241198	1						2	Injection site hypersensitivity; Injection site inflammation	FLU3~PARKDALE PHARMACEUTICALS~02988P~1~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~MERCK & CO. INC.~087041~1~~LA~PNEUMO (PNEUMOVAX)~2|TD~LEDERLE LABORATORIES~454678~1~~RA~TD ADSORBED (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0116963	02/11/1999	MD	78.0	78		F	12/15/1998	Pt recv vax on 10/22/98; on 11/10/98 pt exp pain in right knee & calf, difficulty walking, vomiting, diarrhea									U	10/22/1998	11/10/1998	19	UNK	PUB	PUB	Triamterene, Atenol	NONE	Possible Alzheimer's disease, hypertension	UNK~ ()~~~In patient	898352016A	1						2	Arthralgia; Diarrhoea; Gait disturbance; Pain; Vomiting	FLU3~PFIZER\WYETH~4988212~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0117132	02/11/1999	CO	24.0	23		F	11/06/1998	Pt recv vax on 10/22/98; on same day pt exp rash/ hives, dyspnea, vomiting, cough, confusion & headache; dx=allergic urticaria, pruritic disorder, accidental drug poisoning; tx=Solu-Medrol, Benadryl & Ativan				Y					Y	10/22/1998	10/22/1998	0	UNK	PUB	PUB	Proventyl	NONE	UNK	Pt recv flu vax in '97-98, exp rash~ ()~~~In patient	898314081A	1						2	Confusional state; Cough; Dyspnoea; Headache; Hypersensitivity; Rash; Urticaria; Vomiting	FLU3~PFIZER\WYETH~4988216~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0117511	02/11/1999	MS	37.0	36		F	12/18/1998	Pt recv vax on 12/15/98; on 12/16/98 pt exp tingling of left wrist & hand, sore neck & cold sore on lip				Y					U	12/15/1998	12/16/1998	1	UNK	PUB	OTH	NONE	NONE	allergic to Seldane, Percodan and steroids;	UNK~ ()~~~In patient	898355056A	1						2	Mouth ulceration; Myalgia; Neck pain; Paraesthesia	FLU3~PFIZER\WYETH~4988215~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0118256	02/11/1999	CA	76.0			F	10/20/1998	pt recv vax & exp pain in lt arm 5 days p/vax;									Y	10/07/1998	10/12/1998	5		OTH	OTH	NONE	unk	allergic to mushrooms	pt recv vax & subsequently devel tendinitis;~ ()~~~In patient	898300108A	1						2	Tendon disorder; Pain	FLU3~PFIZER\WYETH~4978179~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0118543	02/11/1999	NY	34.0	34		M	12/28/1998	Pt recv vax on 10/28/98; post vax pt exp shaking, nervous, worse neutropenia				Y					N	10/28/1998	11/19/1998	22	11/9/98:  WBC 3,400	PUB	PUB	Lidex cream, Lac-hydrin lotion	Rash on arm	Neutropenia(prior to vaxWBC 4,500);allergic to Penicillin	UNK~ ()~~~In patient	898363075A	1						2	Leukopenia; Nervousness; Tremor; Anxiety; Leukopenia; Tremor	FLU3~PFIZER\WYETH~4988212~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4988212~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0118882	02/11/1999	IL	49.0	49		F	02/05/1999	severe h/a then nausea & severe vomiting;extreme nausea cont;pain in abd & chest;went to ER via husband transported;still had severe h/a;med given; hosp over noc on monitor;					Y	2			Y	11/03/1998	11/04/1998	1	pt had same type of scan to head which was negative;drew blood (can't recall results);might have had another test;	PUB	PVT	NONE	not to my knowledge	allergy to PCN	pt exp large scab center as child w/?smallpox vax;~ ()~~~In patient		1						1	Abdominal pain; Headache; Vomiting	FLU3~CONNAUGHT LABORATORIES~0975790~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0118885	02/11/1999	PA	53.0	53		F	02/10/1999	pt exp achiness in deltoid region & groin & had no energy p/vax (date unclear);10 days p/onset pt saw MD who dx polymyalgia rheumatica & prescribed pred;approx 1mo later seen by rheumatologist who slowly took pt off med;swollen hands, tired Annual follow-up received on 10/2/00 provided no additional data.								Y	N	11/01/1998	11/02/1998	1	NONE	OTH	OTH			pt has always had fibromyalgia;hayfever;allergy to ragweed,dust,trees		MPI199900056	1						1	Arthritis; Asthenia; Condition aggravated; Granuloma; Hypokinesia; Laboratory test abnormal; Myalgia; Oedema peripheral; Pain; Serum sickness; Vasculitis	FLU3~MEDEVA PHARMA, LTD.~~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0118936	02/11/1999	GA				F	10/21/1998	pt recv vax & devel anaphylaxis;pt was taken to ER by emergency medical personnel, treated & sent home;			Y	Y					Y	10/19/1998	10/19/1998	0		PVT	OTH	unk	NONE		~ ()~~~In patient	898295016A	1						1	Anaphylactoid reaction; Dyspnoea; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening	Influenza
0118937	02/11/1999	VA				F	11/03/1998	pt recv vax 23OCT98 & 25OCT98 presented to ER w/sx similar to anaphylactic rxn including resp distress & hypotension;treated & sent home;			Y	Y					Y	10/23/1998	10/25/1998	2		OTH	OTH	unk	unk		~ ()~~~In patient	898313094A	1						1	Anaphylactoid reaction; Hypotension; Respiratory disorder	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening	Influenza
0118939	02/11/1999	OR	77.0	77		F	10/02/1998	pt inadvertently recv 2 doses of flu vax 2OCT98;one dose was administered subcutaneous;late that evening, pt devel black & blue mark @ inj site & insomnia;pt felt miserable;									Y	10/02/1998	10/02/1998	0		PUB	PUB	NONE	NONE		~ ()~~~In patient	898278067A	1						1	Injection site hypersensitivity; Insomnia; Malaise	FLU3~PFIZER\WYETH~4988200~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1389K~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0118940	02/11/1999	IN				U	10/16/1998	pt recv vax 14OCT98 & 24hr later devel redness @ the inj site;									U	10/14/1998	10/15/1998	1		PVT	OTH	unk	NONE		~ ()~~~In patient	898296026A	1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~4988205~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118941	02/11/1999	IN				U	10/16/1998	pt recv vax 14OCT98 & 24hr later devel redness @ the inj site;									U	10/14/1998	10/15/1998	1		PVT	OTH	unk	NONE		~ ()~~~In patient	898296027A	1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~4988205~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118942	02/11/1999	IN				U	10/16/1998	pt recv vax 14OCT98 & 24hr later devel redness @ the inj site;									U	10/14/1998	10/15/1998	1		PVT	OTH	unk	NONE		~ ()~~~In patient	898296028A	1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~4988205~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118943	02/11/1999	IN				U	10/16/1998	pt recv vax 14OCT98 & 24hr later devel redness @ the inj site;									U	10/14/1998	10/15/1998	1		PVT	OTH	unk			~ ()~~~In patient	898296029A	1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~4988205~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118944	02/11/1999	CA				U	10/22/1998	pt recv vax & devel redness @ the inj site which was not outside of the nl range p/vax;									U					OTH	OTH	unk	unk		~ ()~~~In patient	898300067A	1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118945	02/11/1999	KS	32.0	32		F	10/22/1998	pt recv vax 20OCT98 & devel an inj site rxn characterized by redness & pain;									U	10/20/1998	10/22/1998	2		OTH	OTH	NONE	NONE		pt has rcv at least 3 prev influenza virus vaccines w/o adverse experience;~ ()~~~In patient	898300068A	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~~4~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118946	02/11/1999	MO	27.0	27		M	10/22/1998	Pt recv vax & devel an inj site react characterized by redness & swelling w/bumps p/vax 20OCT98;									U	10/20/1998				PUB	OTH	NONE	unk		~ ()~~~In patient	898300069A	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118947	02/11/1999	LA				U	10/21/1998	pt recv vax 19OCT98 & exp nausea the next day;									U	10/19/1998	10/20/1998	1		OTH	OTH	unk	unk		~ ()~~~In patient	898300103A	1						1	Nausea	FLU3~PFIZER\WYETH~4988203~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118948	02/11/1999	LA				U	10/21/1998	pt recv vax 19OCT98 & exp nausea the next day;									U	10/19/1998	10/20/1998	1		OTH	OTH	unk	unk		~ ()~~~In patient	898300104A	1						1	Nausea	FLU3~PFIZER\WYETH~4988203~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118949	02/11/1999	LA				U	10/21/1998	pt recv vax 19OCT98 & exp nausea the next day;									U	10/19/1998	10/20/1998	1		OTH	OTH	unk	unk		~ ()~~~In patient	898300105A	1						1	Nausea	FLU3~PFIZER\WYETH~4988203~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118950	02/11/1999	LA				U	10/21/1998	pt recv vax 19OCT98 & exp nausea the next day;									U	10/19/1998	10/20/1998	1		OTH	OTH	unk	unk		~ ()~~~In patient	898300106A	1						1	Nausea	FLU3~PFIZER\WYETH~498203~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118951	02/11/1999	LA				U	10/21/1998	pt recv 19OCT98 & exp nausea the next day;									U	10/19/1998	10/20/1998	1		OTH	OTH	unk	unk		~ ()~~~In patient	898300107A	1						1	Nausea	FLU3~PFIZER\WYETH~4988203~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118953	02/11/1999	NY	40.0	39		F	10/21/1998	pt recv vax 19OCT98 & devel an inj site rxn characterized by swelling & warmth;pt also felt flushed;									U	10/19/1998	10/19/1998	0		OTH	PUB	unk	NONE		pt has recv prev doses of influenza virus vac w/o adverse exp~ ()~~~In patient	898300109A	1						1	Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4988212~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118954	02/11/1999	NY	51.0	51		F	10/21/1998	pt recv vax 19OCT98 & devel an inj site rxn characterized by redness, swelling & warmth;									U	10/19/1998	10/20/1998	1		OTH	PUB	unk	NONE		~ ()~~~In patient	898300110A	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4988212~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118955	02/11/1999	NY	43.0	42		F	10/27/1998	Pt recv vax on 10/27/98; 10 min post vax pt exp rt arm sore, 30 min post vax pt exp numbness/ tingling down a line of rt arm to hand/fingers, right neck, face & breast; tx=oral fluids, Claritin, ice; dx=allergic rx to thimerosal; pt imp 2									Y	10/27/1998	10/27/1998	0	UNK	OTH	OTH	NONE	NONE	possible sensitivity to thimerosal in contact lens solutions;	UNK~ ()~~~In patient	898301109A	1						1	Hypersensitivity; Injection site pain; Pain; Paraesthesia; Vasodilatation	FLU3~PFIZER\WYETH~~2~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118956	02/11/1999	UT	68.0			F	10/22/1998	pt recv vax 6OCT98 & 7 days later exp chills & aching;									U	10/06/1998				OTH	OTH	unk	unk		~ ()~~~In patient	898302006A	1						1	Chills; Myalgia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118957	02/11/1999	PA				F	10/23/1998	pt recv vax 20OCT98 & devel an inj site rxn characterized by pain, redness, itching & warmth;also felt like was coming down w/something;									Y	10/20/1998	10/21/1998	1		OTH	OTH	unk	unk		~ ()~~~In patient	898302007A	1						1	Injection site hypersensitivity; Injection site pain; Malaise; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118958	02/11/1999	NY	41.0	41		F	10/26/1998	pt recv vax 22OCT98 & w/in 24hr pt devel redness, warmth & pain @ the inj site;48hr later pt devel swelling in the lymph nodes in the lt side of neck & shoulder;									Y	10/22/1998	10/23/1998	1		OTH	PVT	unspecified antihistamines;advil	NONE	environmental allergies	~ ()~~~In patient	898302008A	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Lymphadenopathy; Myalgia; Vasodilatation	FLU3~PFIZER\WYETH~4988212~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118959	02/11/1999	MO	33.0	33		F	10/29/1998	pt recv vax 21OCT98 & w/in 1hr exp inj site pain which radiated to the left side of neck & base of skull;									Y	10/21/1998	10/21/1998	0		PUB	OTH	Flonase nasal spray	unk		~ ()~~~In patient	898306038A	1						1	Injection site pain; Neck pain	FLU3~PFIZER\WYETH~~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118960	02/11/1999	TX				U	10/29/1998	Pt recv vax on unknown day; post vax pt exp red/swollen/itchy vax site									U				UNK	OTH	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient	898306039A	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118961	02/11/1999	NY				F	10/23/1998	pt recv vax 22OCT98 & the next morning devel swollen joints in hands  & erythema palmar, lt greater than right;									U	10/22/1998	10/23/1998	1		OTH	OTH	unk	unk		~ ()~~~In patient	898307001A	1						1	Osteoarthritis; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4988220~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118962	02/11/1999	NJ	65.0	64		F	10/30/1998	pt recv vax 22OCT98 & devel an inj site rxn characterized by a 12cm by 6cm rectangular shaped area of redness, swelling, itching & a raised rash w/raised border;				Y					Y	10/22/1998	10/23/1998	1		PVT	PVT	Hydrodiuril;synthroid	NONe	hypothyroidism, HVD, CAD, hypercholesterolemia	~ ()~~~In patient	898307064A	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4988220~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0118963	02/11/1999	NC	15.0	14		M	10/30/1998	pt recv vax 29OCT98 & the next day devel swelling around eyes, lips & face & was feeling poorly;pt was seen by MD & tx w/DPH;				Y					Y	10/29/1998	10/30/1998	1		OTH	PVT	none	NONE	asthma, migraine headaches, congenital heart defect	none~ ()~~~In patient	898309045A	1						1	Face oedema; Malaise	FLU3~PFIZER\WYETH~4988208~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0118964	02/11/1999	WI	66.0	66		F	10/09/1998	Pt recv vax on 10/8/98; on same day pt exp left knee stiffness w/ swelling									U	10/08/1998	10/08/1998	0	UNK	OTH	OTH	Prilosec, Premarin, Naproxen, Synvisc (#3dose)	UNK	Osteoarthritis of knees, GERD	UNK~ ()~~~In patient	898310002L	1						1	Gait disturbance; Hypertonia; Osteoarthritis	FLU3~PFIZER\WYETH~~1~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118965	02/11/1999	SC	24.0			F	10/28/1998	Pt recv vax on 10/21/98; on 10/22/98 pt exp fever (104F), lump/red vax site-LA, swelling in throat & axillary lymph node; tx=Prednisone, Benadryl, ice				Y					U	10/21/1998	10/22/1998	1	UNK	OTH	OTH	NONE	UNK	UNK		898313001L	1						1	Injection site hypersensitivity; Injection site mass; Lymphadenopathy; Pyrexia; Hypersensitivity; Injection site hypersensitivity; Injection site mass; Laryngospasm; Lymphadenopathy; Paraesthesia; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454959~1~SC~LA~PNEUMO (PNU-IMUNE)~1|FLU3~CONNAUGHT LABORATORIES~967040~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~454959~1~SC~LA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0118966	02/11/1999	OK	30.0			U	11/04/1998	pt recv vax 2NOV98 & 48hr later devel brown, scaly spots described as liver spots on the chest & arms;									U	11/02/1998	11/04/1998	2		OTH	OTH	Mylanta;APAP	NONE		~ ()~~~In patient	898313018A	1						1	Skin discolouration; Skin disorder	FLU3~PFIZER\WYETH~4988228~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118967	02/11/1999	OK	40.0	40		F	11/04/1998	pt recv vax 3NOV98 & that evening pt devel an inj site rxn characterized by a big wheal & knot;									Y	11/02/1998	11/02/1998	0		OTH	PVT	Sudafed;APAP	NONE	obesity	pt devel a wheal & knot @ the inj site p/vax see MCN 899011004L~ ()~~~In patient	898313020A	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4988228~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118968	02/11/1999	PA	39.0	39		F	11/06/1998	pt recv vax 10OCT98 & the next day pt devel an inj site rxn characterized by swelling & tenderness;later, pt exp pain on lt side of body from arm to foot;6NOV98 only lt hip is painful;									U	10/10/1998	10/11/1998	1		OTH	OTH	Norethin	NONE		~ ()~~~In patient	898313130A	1						1	Arthralgia; Injection site oedema; Injection site pain; Myalgia; Pain	FLU3~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118969	02/11/1999	MA	45.0	45		F	11/09/1998	Pt recv vax on 10/16/98; on 10/17/98 pt exp swollen & painful breasts				Y					Y	10/16/1998	10/17/1998	1	Prolactin level-elevated	PVT	PVT	calan, naproxen	NONE	Hx of breast cancer (right) w/ lumpectomy 6.5 yr ago;hypertension, hemorrhoids, amenorrhea since chemotherapy;	UNK~ ()~~~In patient	898314095A	1						1	Laboratory test abnormal; Oedema; Pain	FLU3~PFIZER\WYETH~4978193~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0118970	02/11/1999	AR	31.0	31		F	11/09/1998	Pt recv vax on 11/6/98; on 11/7/98 pt exp hives; tx=Benadryl									U	11/06/1998	11/07/1998	1	UNK	PUB	OTH	Tuberculin, PPD, Tine test, Tiazac, Zestril, Ezol	NONE	NONE	NONE~ ()~~~In patient	898315050A	1						1	Urticaria	FLU3~PFIZER\WYETH~~6~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118971	02/11/1999	NJ				M	11/11/1998	pt recv vax 6NOV98 & 2 days later pt devel swelling of the rt axillary & cervical lymph nodes, as well as an inj sit rxn characterized by sl redness & mild tenderness;									U	11/06/1998	11/08/1998	2		PVT	PVT	NONE	NONE		pt devel swelling of single ax lymph node p/flu vax see 899011002L~ ()~~~In patient	898316058A	1						1	Injection site hypersensitivity; Injection site pain; Lymphadenopathy	FLU3~PFIZER\WYETH~4988220~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118972	02/11/1999	AK	20.0			M	11/12/1998	pt recv vax 3NOV98 & the next day pt devel an inj site rxn characterized by a 3cm by 4cm area of swelling, induration & numbness;the rxn occurred sl distal to site of needle insertion;				Y					U	11/03/1998	11/04/1998	1		OTH	OTH	Topical acne medication	unk	acne	~ ()~~~In patient	898317042A	1						1	Injection site mass; Injection site oedema; Paraesthesia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0118973	02/11/1999	PA				M	11/12/1998	pt recv vax 11NOV98 & devel an inj site rxn characterized by a 25 cent size area of erythema & itching;pt recovered w/in 1hr;									Y	11/11/1998	11/11/1998	0		PVT	PVT	unk	NONE		~ ()~~~In patient	898320029A	1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118974	02/11/1999	PA				F	11/12/1998	pt recv vax 11NOV98 & the next day pt devel an inj site rxn characterized by a 25-cent size area of erythema & itching;pt recovered w/in 1hr;									Y	11/11/1998	11/12/1998	1		PVT	PVT	unk	NONE		~ ()~~~In patient	898320030A	1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118975	02/11/1999	PA				F	11/12/1998	pt recv vax 11NOV98 & devel an inj site rxn characterized by a 25 cent area of induration, warmth, & itching;				Y					U	11/11/1998	11/11/1998	0		PVT	PVT	unk	NONE	p	pt devel induration, erythema & itching @ inj site p/flu vax see 898337002L~ ()~~~In patient	898320031A	1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~~2~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0118976	02/11/1999	CA	86.0			F	11/13/1998	Pt recv vax on 11/9/98; on 11/10/98 pt exp elevated liver enzymes				Y					U	11/09/1998	11/10/1998	1	11/10/98-SGPT 321, SGOT 247; 11/12/98-SGPT 247, SGOT 225	PVT	PVT	Calcitonin, Calcium, Oxycodone, Levothyroxine, Vitamin E, Pepcid, Senokot S, Xanax	NONE	UNK	UNK~ ()~~~In patient	898320033A	1						1	Alanine aminotransferase increased; Aspartate aminotransferase increased	FLU3~PFIZER\WYETH~~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0118977	02/11/1999	KS	40.0			U	10/23/1998	Pt recv vax on unknown day; within 24 hr post vax pt exp fever >102F & red PPV vax site, sick feeling				Y					U				UNK	PUB	OTH	UNK	NONE	Smoker	UNK~ ()~~~In patient	898322002L	1						1	Injection site hypersensitivity; Malaise; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~IM A~~PNEUMO (PNU-IMUNE)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0118978	02/11/1999	FL	44.0	44		M	11/18/1998	Pt recv vax on 11/4/98; on 11/11/98 pt exp headache, muscle aches, fatigue									Y	11/04/1998	11/10/1998	6	UNK	PVT	OTH	Augmentin, Pentasa	NONE	NONE	NONE~ ()~~~In patient	898323100A	1						1	Asthenia; Headache; Myalgia	FLU3~PFIZER\WYETH~~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118979	02/11/1999	CA	42.0	42		F	12/01/1998	Pt recv vax on 11/2/98; on 11/4/98 pt exp flu sx of myalgia, arthralgia, malaise, nausea & slight twitch				Y					U	11/02/1998	11/04/1998	2	Blood tests-normal	OTH	PUB	Albuterol inhaler, Chromalin sodium inhaler, Asthmacort inhaler	NONE	Asthma	UNK~ ()~~~In patient	898337017A	1						1	Arthralgia; Influenza; Malaise; Muscle twitching; Myalgia; Nausea	FLU3~PFIZER\WYETH~4988249~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0118980	02/11/1999	IN				U	11/20/1998	pt recv vax & 2 days later devel an inc in bilirubin levels;bilirubin levels subsequently returned to nl;				Y					Y					PVT	PVT	Rezulin;Quinine	unk		~ ()~~~In patient	898327045A	1						1	Cholelithiasis; Hyperbilirubinaemia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0118981	02/11/1999	WI	57.0	57		F	11/23/1998	pt recv vax 14OCT98 & the next day exp inj site pain which radiated to the axilla & to the elbow;tx w/applications of ice;				Y					U	10/14/1998	10/14/1998	0		OTH	OTH	Premarin	None	None	~ ()~~~In patient	898328042A	1						1	Injection site pain; Pain	FLU3~PFIZER\WYETH~4988024~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0118982	02/11/1999	NJ	44.0			M	12/04/1998	Pt recv vax on 10/28/98; on 11/2/98 pt exp swelling on left side of lip, unable to blink or close left eye, increased left side facial droop; dx=Bell's Palsy				Y					U	10/28/1998	11/02/1998	5	Seen by dentist to rule out dental abscess	OTH	PUB	Inderal, Multivitamin, Colase	UNK	Left side facial droop, premature birth, mental retardation, hypertension, constipation	UNK~ ()~~~In patient	898341091A	1						1	Condition aggravated; Eye disorder; Facial palsy; Hypotonia	FLU3~PFIZER\WYETH~4988228~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0118983	02/11/1999	CA	34.0	34		F	12/01/1998	pt recv vax 30NOV98 & w/in 12hr exp flu like sx including sore throat, h/a & myalgia;									U	11/30/1998	11/30/1998	0		PVT	OTH	unk	unk	influenza 2 weeks prior to receiving immunization;	~ ()~~~In patient	898341012A	1						1	Headache; Influenza; Myalgia; Pharyngitis; Headache; Influenza; Myalgia; Pharyngitis	FLU3~PFIZER\WYETH~~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~~LA~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~~UNK~~LA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0118985	02/11/1999	SC	48.0			M	10/28/1998	pt recv vax 21OCT98 & w/in 48hr devel a fever ranging from 101.4 to 101.8 & redness @ pnu immune inj site;MD dx flu;									U	10/21/1998	10/23/1998	2		OTH	OTH	unk	unk		~ ()~~~In patient	898343001L	1						1	Infection; Injection site hypersensitivity; Pyrexia; Injection site hypersensitivity; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~454959~UNK~SC A~~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~454959~UNK~SC A~~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0118986	02/11/1999	WI				F	12/09/1998	Pt recv vax in 11/98; during the vax pt exp flushing sensation down arm, the next day pt exp soreness at vax site x 3 wk									U	11/01/1998	11/01/1998	0	UNK	OTH	OTH	UNK	UNK	UNK	UNK~ ()~~~In patient	898345004A	1						1	Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118987	02/11/1999	GA	62.0			F	12/10/1998	Pt recv vax in 11/98; 4 - 5 day post vax pt exp itching & pimples filled w/ water at vax site x 10 day									Y	11/01/1998	11/01/1998	0	UNK	PVT	OTH	Premarin, Provera	NONE	UNK	UNK~ ()~~~In patient	898345103A	1						1	Pruritus; Rash maculo-papular	FLU3~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118988	02/11/1999	AZ	2.0			M	12/16/1998	Pt recv vax on 12/14/98; on same day pt exp fever (104F)									U					PVT	OTH	Vancomycin IV, Unisyn IV	Pneumonia	UNK	UNK~ ()~~~In patient	898351082A	1						1	Pyrexia	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~1~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0118990	02/11/1999	WV	65.0	65		F	10/15/1998	Pt recv vax on 10/10/98; on 10/11/98 pt exp fever, (101F), swell/ pain at vax site; 10/12 pt exp pain in fingertips; pt imp 10/15/98									U	10/10/1998	10/11/1998	1	UNK	OTH	OTH	Augmentin	Interstitial cystitis	UNK	UNK~ ()~~~In patient	898355002L	1						1	Injection site oedema; Injection site pain; Injection site oedema; Injection site pain; Pain; Pyrexia; Asthenia; Chest pain; Ecchymosis; Headache; Hypokinesia; Myalgia; Neck pain; Pyrexia; Rhinitis; Tachycardia; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~1~~~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~~1~A~~PNEUMO (PNU-IMUNE)~2|FLU3~CONNAUGHT LABORATORIES~0871H~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~~1~IM~LA~PNEUMO (PNEUMOVAX)~3	USA		Influenza
0118992	02/11/1999	NY	68.0	67		F	11/16/1998	Pt recv vax on 11/5/98; on 11/6/98 pt exp pain in LA, nausea x 5 day; 11/13/98 pt exp pain/swelling at LA vax site									U	11/05/1998	11/06/1998	1	UNK	PVT	PVT	Pepcid 40 -60 mg daily	NONE	Barrett's esophagus	UNK~ ()~~~In patient	898362001L	1						1	Injection site oedema; Injection site pain; Nausea; Pain; Injection site oedema; Injection site pain; Nausea; Pain; Cellulitis; Hypokinesia; Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Insomnia; Nausea	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~1~IM~LA~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~~1~IM~LA~PNEUMO (PNU-IMUNE)~2|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~3	USA		Influenza
0118993	02/11/1999	CO	43.0	43		F	12/21/1998	Pt recv vax on 10/21/98; on 10/23/98 pt exp headache, nausea & body aches				Y					Y	10/21/1998	10/23/1998	2	UNK	PUB	PUB	Zestril	NONE	Hypertension	NONE~ ()~~~In patient	899006002L	1						1	Headache; Myalgia; Nausea	FLU3~PFIZER\WYETH~4988216~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0118994	02/11/1999	NC				U	12/29/1998	Pt recv vax in 12/98; immediately post vax pt exp knot at vax site w/ purple color									U	12/01/1998	12/01/1998	0	UNK	PUB	PUB	UNK	NONE	HIV infection	UNK~ ()~~~In patient	898365097A	1						1	Injection site mass; Skin discolouration	FLU3~PFIZER\WYETH~4988208~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0118995	02/11/1999	NC				M	12/29/1998	Pt recv vax on 12/29/98; immediately post vax pt exp knot at vax site; tx=ice									U	12/29/1998	12/29/1998	0	UNK	PUB	PUB	UNK	NONE	UNK	UNK~ ()~~~In patient	898365098A	1						1	Injection site mass	FLU3~PFIZER\WYETH~4988208~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~1~A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0118996	02/11/1999	CO	31.0	31		M	12/21/1998	Pt recv vax on 10/22/98; on 10/26/98 pt exp stomach cramps, diarrhea, chest tight, congestion, sore throat, headache, fever									Y	10/22/1998	10/26/1998	4	UNK	PUB	PUB	Zithromax	UNK	UNK	UNK~ ()~~~In patient	899006003L	1						1	Abdominal pain; Chest pain; Diarrhoea; Headache; Pharyngitis; Pyrexia; Rhinitis	FLU3~PFIZER\WYETH~4988216~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118997	02/11/1999	CO	44.0	44		M	12/21/1998	Pt recv vax on 10/23/98; on same day pt exp eye pressure, nausea, dizzy									Y	10/23/1998	10/23/1998	0	UNK	PUB	PUB	UNK	NONE	UNK	UNK~ ()~~~In patient	899006004L	1						1	Dizziness; Eye disorder; Nausea	FLU3~PFIZER\WYETH~4988216~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0118998	02/11/1999	CO	33.0	33		M	12/21/1998	Pt recv vax on 10/23/98; on same day pt exp congestion, sneezing, cough & dizzy; 10/26/98 pt exp headache & lethargy; dx=R/O viral				Y					Y	10/23/1998	10/26/1998	3	UNK	PUB	PUB	NONE	NONE	UNK	NONE~ ()~~~In patient	899006005L	1						1	Cough; Dizziness; Headache; Rhinitis; Somnolence	FLU3~PFIZER\WYETH~4988216~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0119100	02/11/1999	OK	43.0	43		F	11/05/1998	Pt recv vax on 11/4/98; 2 hr post vax pt exp red/ glassy eyes & no  energy									Y	11/04/1998	11/04/1998	0	NONE	OTH	OTH	UNK	UNK	High blood pressure	NONE~ ()~~~In patient	FLU90041198	1						1	Asthenia; Conjunctivitis; Stupor	FLU3~PARKDALE PHARMACEUTICALS~00408P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0119101	02/11/1999	UT	41.0	41		F	11/11/1998	Pt recv vax on 11/10/98; 1 hr post vax pt exp headache, rapid heart beat, wheezing, coughing, dry/burning eyes, achiness, dizzy, difficulty breathing									Y	11/10/1998	11/10/1998	0	NONE	PUB	PUB	UNK	NONE	Allergy to sulfites, sulfonamides	NONE~ ()~~~In patient	FLU90111198	1						1	Asthma; Cough; Dizziness; Dyspnoea; Eye disorder; Eye pain; Headache; Myalgia; Tachycardia	FLU3~PARKDALE PHARMACEUTICALS~00408P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0119102	02/11/1999	TX	31.0	31		F	11/24/1998	Pt recv vax on 11/3/98; on same day pt exp red/swollen/sore area, unable to raise rt arm above shoulder									Y	11/03/1998	11/03/1998	0	NONE	OTH	OTH	Birth control pill	NONE	Allergic to Penicillin	NONE~ ()~~~In patient	FLU90201198	1						1	Hypokinesia; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~01998P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0119104	02/11/1999	KS	69.0	69		M	11/25/1998	Pt recv vax on 10/13/98; on same day pt exp swollen, painful lump on LA vax site									U	10/13/1998	10/13/1998	0	UNK	PUB	PUB	UNK	NONE	Hospitalized in 9/98 w/ pneumonia	NONE~ ()~~~In patient	FLU90251198	1						1	Injection site mass; Injection site oedema; Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~01998P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0119105	02/11/1999	FL	40.0	40		F	12/29/1998	Pt recv vax on 10/22/98; immediately post vax pt exp vax site burning, tingling of LA, aching x 45 min									Y	10/22/1998	10/22/1998	0	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	FLU92231298	1						1	Myalgia; Pain; Paraesthesia	FLU3~PARKDALE PHARMACEUTICALS~03088P~1~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0119106	02/11/1999	TN	72.0	72		F	12/18/1998	Pt recv vax on 11/4/98; on 11/25/98 pt exp sore left deltoid muscle									Y	11/04/1998	11/25/1998	21	NONE	PVT	OTH	UNK	UNK	Allergic to Sulfa	NONE~ ()~~~In patient	FLU93040199	1						1	Myalgia; Pain	FLU3~PARKDALE PHARMACEUTICALS~02298P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0119108	02/11/1999	OK	43.0	43		F	11/05/1998	Pt recv vax on 11/4/98; on same day pt exp red/glassy eyes & excessive drainage in throat & no energy									Y	11/04/1998	11/04/1998	0	NONE	PVT	PVT	Benadryl	NONE	NONE	NONE~ ()~~~In patient	FLU90051198	1						1	Asthenia; Conjunctivitis; Salivary hypersecretion; Stupor	FLU3~PARKDALE PHARMACEUTICALS~00408P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0119109	02/11/1999	WI	53.0	53		M	11/13/1998	Pt recv vax on 11/4/98; on same day pt exp feeling sick, achy, cough, congestion									Y	11/04/1998	11/04/1998	0	NONE	PUB	PUB	UNK	NONE	NONE	NONE~ ()~~~In patient	FLU90131198	1						1	Cough; Lung disorder; Malaise; Myalgia; Rhinitis	FLU3~PARKDALE PHARMACEUTICALS~00508P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0119110	02/11/1999	WI	49.0	48		M	11/13/1998	Pt recv vax on 11/4/98; on same day pt exp not feeling good, achy, possible congestion									Y	11/04/1998	11/04/1998	0	NONE	PUB	PUB	UNK	NONE	NONE	NONE~ ()~~~In patient	FLU90141198	1						1	Lung disorder; Malaise; Myalgia; Rhinitis	FLU3~PARKDALE PHARMACEUTICALS~00508P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0119111	02/11/1999	TX	36.0	36		F	11/24/1998	Pt recv vax on 11/3/98; on same day pt exp sore, irritated, swollen, inflamed rt arm, rash, hot to touch									Y	11/03/1998	11/03/1998	0	NONE	OTH	OTH	Efesexor, Buspra, Multivitamin	NONE	Arthritis, Gastritis, Allergic to Codeine & Penicillin	NONE~ ()~~~In patient	FLU90191198	1						1	Oedema; Pain; Rash; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~01998P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0119112	02/11/1999	TX	25.0	25		M	11/11/1998	Pt recv vax on 11/3/98; on same day pt exp rash on vax site arm x 24 hr									Y	11/03/1998	11/03/1998	0	UNK	PVT	OTH	UNK	NONE	NONE	NONE~ ()~~~In patient	FLU90211198	1						1	Rash	FLU3~PARKDALE PHARMACEUTICALS~01998P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0119115	02/11/1999	NC	31.0	31		F	01/12/1999	Pt recv vax on 1/4/99; on same day pt exp erythema, raised induration, soreness, itching									Y	01/04/1999	01/04/1999	0	NONE	PUB	OTH	UNK	NONE	NONE	NONE~ ()~~~In patient	FLU93050199	1						1	Myalgia; Pain; Pruritus; Rash maculo-papular	FLU3~PARKDALE PHARMACEUTICALS~02198P~1~ID~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0119116	02/11/1999	MI	66.0	66		M	12/07/1998	Pt recv vax on 10/29/98; on 11/22/98 pt exp groaning stomach, stomach pain, diarrhea x 2 wk, muscle aches x 3-4 days, fever, headache & malaise									Y	10/29/1998	11/22/1998	24	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	FLU91121298	1						1	Abdominal pain; Diarrhoea; Headache; Malaise; Myalgia; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~03088P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0118920	02/12/1999	WA	51.0	51		F	02/08/1999	Pt recv vax on 1/22/99; approx 4 1/2 hr post vax pt exp lightheaded, warm from chest up, red face &neck, increased heart rate, dizzy, hot flashes; tx=Benadryl, cortisone				Y					Y	01/22/1999	01/22/1999	0	Chest X-ray, Bloodwork-WNL	PUB	PUB	Estradiol, Blood pressure medicine	NONE	Hypertension, Allergic to Sulfa	NONE~ ()~~~In patient		1						1	Dizziness; Rash; Tachycardia; Vasodilatation	FLU3~PFIZER\WYETH~4988200~6~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~455936~1~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0119009	02/16/1999	GA	35.0	35		F	12/10/1998	Pt recv vax on 12/7/98; on same day pt exp swollen hands, aching all over & vomiting; dx=intestinal infection; tx=Cefzil, Phenergan, Leusin				Y					Y	12/07/1998	12/07/1998	0	UNK	PUB	PUB	UNK	NONE	Intestinal problem	UNK~ ()~~~In patient	GA98135	1						1	Gastrointestinal disorder; Infection; Myalgia; Oedema peripheral; Vomiting	FLU3~PFIZER\WYETH~4988235~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HIBV~MERCK & CO. INC.~0430H~3~IM~LA~HIB (PEDVAXHIB)~1	USA	Emergency room visit	Influenza
0119017	02/16/1999	OK	67.0	67		M	11/04/1998	Pt recv vax on 11/3/98; on same day pt exp pain, red, swelling, warmth of rt arm				Y					U	11/03/1998	11/03/1998	0	UNK	PUB	PUB	UNK	NONE	Heart trouble	UNK~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4988249~6~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1510E~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0119018	02/16/1999	OK	66.0	66		F	10/28/1998	Pt recv vax on 10/26/98; on 10/28/98 pt exp edematous rt arm w/ erythema; dx=cellulitis; tx=Keflex				Y					Y	10/26/1998	10/28/1998	2	UNK	PUB	PUB	UNK	NONE	NONE	UNK~ ()~~~In patient		1						1	Cellulitis; Oedema peripheral; Rash	FLUX~UNKNOWN MANUFACTURER~4988249~4~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1510E~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0119019	02/16/1999	OK	23.0	23		F	11/03/1998	Pt recv vax on 10/28/98; on 10/29/98 pt exp febrile rx (102F) & pain/cellulitis in rt arm x 3 day; tx=Cephalexin & Tylenol				Y					Y	10/28/1998	10/29/1998	1	UNK	PUB	PUB	NONE	NONE	NONE	UNK~ ()~~~In patient		1						1	Cellulitis; Pain; Pyrexia; Vasodilatation; Cellulitis; Infection; Injection site hypersensitivity; Injection site pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~4988204~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1510E~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~0939440~5~IM~LA~TD ADSORBED (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~4988249~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~1510E~1~IM~RA~PNEUMO (PNEUMOVAX)~2|TD~CONNAUGHT LABORATORIES~0939440~5~IM~LA~TD ADSORBED (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0119020	02/16/1999	OK				F	10/29/1998	Pt recv vax on 10/28/98; on 10/29/98 pt exp pain/swelling/ hot/red LA; dx=cellulitis; tx=Keflex				Y					U	10/28/1998	10/29/1998	1	UNK	OTH	PUB	UNK	NONE	NONE	UNK~ ()~~~In patient		1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~4988249~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~1510E~2~IM~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0119082	02/17/1999	RI				F	11/30/1998	2wk p/vax having numbness in lt foot;during next wk progressed up to knee, lt hand & lt side of face;during the next 2mo sx improved then reappeared w/joint pain being constant;dx vaccine toxicity;4wk p/sx resolved x/sl numbness in lt foot;									U				MRI head negative;	UNK	UNK		NONE	PCN, bees			1						1	Arthralgia; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0115595	02/18/1999	IL	19.0	19		M	02/15/1999	Pt recv vax in 10/98;  on 10/16/98 pt exp cold-like upper respiratory symptoms, dizzy, numb hands &feet, dysphasia, weakness & fatigue.  Annual follow-up received on 2/15/01 provided no additional data.					Y				U	10/06/1998	10/16/1998	10	10/24/98:  Lumbar puncture-negative, CSF protein-64, Sedrate-2, EMG-borderline abnormalities w/ scattered prolongation of distal latencies & prolonged F latencies-suggestive early GBS	OTH	OTH	NONE	NONE	NONE			1						2	Asthenia; CSF test abnormal; Dizziness; Guillain-Barre syndrome; Laboratory test abnormal; Paraesthesia; Pharyngitis; Rhinitis; Speech disorder	FLU3~PARKDALE PHARMACEUTICALS~02988P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Hospitalisation	Influenza
0119122	02/18/1999	RI	60.0	59		F	02/10/1999	Pt recv  vax on 11/2/98; on 11/13/98 pt exp fatigue, cold sx, paralysis of legs, respiratory failure-intubated; tx=oxygen, physical therapy; Annual follow-up dated 12/21/00 states that the pt reports some improvement, hoever legs remain paralyzed, also reports she was diagnosed with Gullain Barre syndrome.				Y	Y	10			N	11/02/1998	11/13/1998	11	MRI-lung mass, neg on spinal cord from T1 down, chest CT- mass 2cm rt upper lung, old brain infarct, calcified aorta, initial ABG-ph 7.125, pCO2 111, pO2 32.1, HCO3 36.1	PVT	OTH	Inhaler, O2 dependent @ home	NONE	Allergic to Penicillin-pulmonary HTN, severe COPD, smokes several packs per wk, past work up for syringomyelia		RI9901	1						1	Apnoea; Asthenia; Guillain-Barre syndrome; Hypoxia; Myelitis; Paralysis; Respiratory disorder	FLU3~CONNAUGHT LABORATORIES~0984560~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0119123	02/18/1999	GA	42.0	42		M	02/11/1999	Pt recv vax on 10/28/98; on 1/6/99 pt exp myalgia, arthralgia & Guillian-Barre syndrome; tx=immune globulin					Y				Y	10/28/1998	01/06/1999	70	Serum creatinine-3.9; most recent CD4 count 7	OTH	OTH	Hydrochlorothiazide, Amitriptyline, Hydroxyzine, Lisinopril	UNK	Hypertension, AIDS, pneumocystic carinii pneumonia, thrush,GE reflux, B-12 dificiency, human immunodeficiency virus nephropathy, echogenic kidneys; allergic to Zidovudine			1						1	Arthralgia; Guillain-Barre syndrome; Myalgia	FLUX~UNKNOWN MANUFACTURER~0972880~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0105870	02/19/1999	NH	76.0	76		F	11/13/1997	Pt recv vax on 10/17/97; on 11/3/97 pt exp Guillain-Barre syndrome				Y	Y	4			N	10/17/1997	11/03/1997	17	Lumbar puncture-dx GBS	OTH	OTH	Zantac, Zestril	NONE	NONE	NONE~ ()~~~In patient	ME98039	1						2	Guillain-Barre syndrome	FLU3~CONNAUGHT LABORATORIES~7F81854~4~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~442521~1~IM A~~PNEUMO (PNU-IMUNE)~2	USA	Hospitalisation	Influenza
0119165	02/19/1999	OK	73.0	73		F	02/07/1999	Pt recv vax on 10/1/98; on same day pt exp chills, sweats, tight chest, short breath, fever (103), tachypneic; dx=febrile rx to vax; tx=IV steroids, Hudson updrafts, Rocephin & Zithromax IV Follow-up: Temp 103; dyspnea, hypoxic, sinus tach (HR 134).				Y	Y	7			Y	10/01/1998	10/01/1998	0	X-rays, BP 99/54, Pulse 108, Respiratory rate 20	PVT	UNK	Norvasc, Allopurinol, Vit E, Claritin, Cozaar, Carafate, Pepcid, DO 24, Lipitor, Tylenol, Ismo	NONE	Hx of breast cancer 15 yr ago (Rt mastectomy), gout, hyperlipidemia, HTN, COPD, peripheral vascular disease, aortic bypass surgery & coronary artery, triple vessel disease, cholecystectomy, D&C	NONE~ ()~~0.00~Patient	OK991	1						1	Chest discomfort; Chills; Dyspnoea; Hyperhidrosis; Hypoxia; Pyrexia; Sinus tachycardia; Tachypnoea; X-ray	FLU3~CONNAUGHT LABORATORIES~0971890~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0119178	02/19/1999	MN	38.0	38		M	02/15/1999	Pt recv vax on 1/11/99; on 1/15/99 pt exp pruritic rash on arms, anterior chest, groin to knees & back x 2.5 wk; tx=Benadryl									Y	01/11/1999	01/15/1999	4	NONE	PVT	PUB	UNK	NONE	Gantrisin-photosensitive	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~0984560~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SMITHKLINE BEECHAM~2700A4~1~~LA~HEP B (ENGERIX-B)~1|MMR~MERCK & CO. INC.~1003H~1~~RA~MEASLES + MUMPS + RUBELLA (MMR I)~1|RAB~CONNAUGHT LTD.~NO4202~1~~RA~RABIES (IMOVAX)~1|YF~CONNAUGHT LABORATORIES~0992630~1~~RA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0112334	02/22/1999	TX	44.0	44		M	12/20/1996	Prolonged hospitalization							Y		U	10/17/1996				PVT	UNK		NONE	NONE	NONE~ ()~~~In patient		1						2	Unevaluable event	FLU3~CONNAUGHT LABORATORIES~6F71247~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0119192	02/22/1999		72.0			M	02/18/1999	pt recv vax & exp bullous skin eruptions p/48hr;skin biopsy suggested bullous pemphigus;3wk p/vax hosp w/lesions & wrist buttock; dx:toxidermia, pemphigus-like;discharged p/ 7 days & symptoms were stated to have resolved.					Y	7			Y	10/19/1998	10/21/1998	2	blood count-MCV 102.4 FP, no anemia, eosinophll polynuclear 4% & sed rat nl	OTH	OTH	Celectol/celiprolol;Diamicron/gliclazide;fenofibrate/fenofibrate;kardegic/salicylic acid;Nicradipine;praxilene;zyloric/allopurinol;		NONE	~ ()~~~In patient	MPF199900070	1						1	Dermatitis bullous; Skin disorder	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0119202	02/22/1999	WA	77.0	76		M	02/06/1999	blurred vision, weakness in body, problem breathing 19DEC, fell 20DEC adm to hosp;CCU 21DEC98 moved to ICU 22DEC put on full life support GBS dx 1FEB taken off life support 4FEB98 transferred to another hosp;			Y	Y	Y	56	Y		N	12/03/1998	12/14/1998	11	too numerous to fill this box;	UNK	OTH	Piroxicam;Lotenson, amitriptilene, albuterol;	treatment of spray to bladder	HTN, diabetes, lumbar stenosis, CA bladder, neuropathy 1972, gait ataxia	NONE~ ()~~~In patient		1						1	Amblyopia; Apnoea; Asthenia; Constipation; Dyspnoea; Guillain-Barre syndrome; Hypoxia; Iron deficiency anaemia; Pruritus	FLU3~CONNAUGHT LABORATORIES~0984560~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~~1~~~PNEUMO (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0119206	02/22/1999	MI	65.0	65		F	01/05/1999	7NOV96 onset of tingling sensation in hands & feet;8NOV96 unable to walk;hosp x 10 days;discharge dx GBS;Annual follow-up dated 10/23/00 states that the pt has aching and burning of lower extremities from knees down.			Y	Y	Y	13			N	10/01/1996	11/07/1996	37		UNK	UNK	Lescol; Motrin	arthritis-back problems	arthritis, chronic back pain, hypercholesteremia		MI99017	1						1	Guillain-Barre syndrome; Hypokinesia; Laboratory test abnormal; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4968172~7+~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0119218	02/22/1999	CO	56.0	56		M	01/21/1999	Pt recv vax on 10/14/98; on same day pt exp pain of rt arm; dx=classic rotator cuff, tendinitis; tx=Motrin				Y					U	10/14/1998	10/14/1998	0	NONE	PUB	PUB	UNK	NONE	UNK	UNK~ ()~~~In patient	CO99001	1						1	Pain; Tendon disorder	FLU3~MEDEVA PHARMA, LTD.~E20188H~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0870H~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0119228	02/22/1999	MI	50.0	50		F		Pt recv vax on 11/5/98; immediately post vax pt exp pain/swelling/weak in LA at vax site, spasms									U	11/05/1998	11/05/1998	0	NONE	PUB	PUB	Estrogen daily	NONE	Allergic to AlleveN	NONE~ ()~~~In patient	MI99006	1						1	Hypertonia; Injection site atrophy; Injection site pain; Myasthenic syndrome	FLU3~PFIZER\WYETH~4988204~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~MERCK & CO. INC.~1605E~1~IM~LA~HEP B (FOREIGN)~1|TD~LEDERLE LABORATORIES~452842~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0119357	02/22/1999	KS	40.0			U	10/23/1998	pt recv vax (MFR unk) & w/in 24hr pt devel fever 102 & redness @ the site of pnu-immune 23 & pt felt sick;pt was seen by MD;				Y					U					PUB	OTH	unk	NONE	smoker	~ ()~~~In patient	898322001L	1						1	Injection site hypersensitivity; Malaise; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~IM A~~PNEUMO (PNU-IMUNE)~1|TTOX~LEDERLE LABORATORIES~~UNK~~~TETANUS TOXOID, ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0108196	02/23/1999	CA	51.0	51		M	03/04/1998	pt recv vax & 2hr later hives all over, diarrhea;no SOB to Er rx w/DPH;resolved by next AM;prev flu shots w/o rxn;prev typhoid shot w/o rxn;				Y					Y	11/01/1997	11/01/1997	0	skin test positive to oral typhoid vaccine capsule extract;	MIL	UNK				~ ()~~~In patient	VIV9808	1						2	Diarrhoea; Urticaria	FLU3~CONNAUGHT LABORATORIES~7J81910~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|TYP~BERNA BIOTECH, LTD.~144771A~1~PO~MO~TYPHOID LIVE ORAL TY21A (VIVOTIF)~2	USA	Emergency room visit	Influenza
0119256	02/23/1999	IL	64.0	64		M	02/01/1999	pt adm to hosp w/ c/o extreme fatigue/muscle weakness/dysuria;impression: abn liver enzymes/myositis/myopathy rhabdomyolysis, renal insufficiency secondary to rhabdo, dialysis required;Annual follow-up dated 11/01/00 provided no additional data.			Y		Y	10			N	12/16/1998	12/25/1998	9	SGOT 1046;SGPT 487;CPK 71,280, TB 1.4;K 6.6;bun/creat 93/2.9 on adm, MCV 101 max 157/7.2;	UNK	UNK	Pred, Neoral, imuran, ASA, aldactone, glipizide, vasotec, glucophage, insulin, hytrin, lanoxin, mevacor;		status post cardiac transplant 5MAR93;			1						1	Alanine aminotransferase increased; Aspartate aminotransferase increased; Asthenia; Blood creatine phosphokinase increased; Blood creatinine increased; Blood urea increased; Cardiovascular disorder; Condition aggravated; Diabetes mellitus; Dysuria; Hepatic function abnormal; Hyperbilirubinaemia; Hyperkalaemia; Hypertension; Myasthenic syndrome; Myopathy; Myositis; Renal failure; Renal impairment; Right ventricular failure	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0119260	02/23/1999	MN	50.0	49		M	02/17/1999	devel herpes zoster shortly p/vax (had not had prev) in same area as inj;				Y					Y	10/04/1998	10/10/1998	6		OTH	PVT		NONE	renal failure, transplant	~ ()~~~In patient		1						1	Herpes zoster; Infection; Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~0975800~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119335	02/24/1999	MD	56.0	56		M	02/19/1999	transverse myelitis of cervical & thoracic spinal cord;					Y			Y	U	10/22/1998	10/23/1998	1	MRI of spine;LP	UNK	UNK	arthritis		arthritis;Reiter's syndrome			1						1	Condition aggravated; Myelitis; Neuropathy; Paraesthesia; Salivary gland enlargement; Skin disorder	FLU3~PARKDALE PHARMACEUTICALS~02888P~7+~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation,Disabling	Influenza
0119374	02/25/1999	MA	7.0	7		M	02/22/1999	pt has hx ITP treated w/splenectomy;has exacerbation of dec platelets 9count 14);1st time post splenectomy;			Y						N	11/20/1998	11/22/1998	2	platelet coutn 20NOV98 97;22NOV98 platelet count 14;	PVT	UNK		NONE	ITP;splenoctomy JUL98	~ ()~~~In patient		1						1	Condition aggravated; Thrombocytopenia	FLU3~CONNAUGHT LABORATORIES~02098P1~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0119376	02/25/1999	CA				U		pt recv vax NOV92 & devel rt upper quad tenderness;it was assumed to be a flair-up of an old chronic ulcerative colitis;colonoscopy did show a mild inflammatory rxn;blood chem revealed elevated liver enzymes & positive hep B surface antigen				Y						11/01/1992				UNK	UNK			chronic active hep B-pt exposed to hep ba 8yr prior w/an accidental needle puncture in OR-never had sx of hep or abn liver diseases;	~ ()~~~In patient		1						1	Colitis ulcerative; Condition aggravated; Hepatic function abnormal; Hepatitis; Infection; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0119397	02/25/1999	WA	25.0	25		M	12/09/1998	4wk p/vax sneezing, hives, lt eye swelled shut got DPH over the noc & sx resolved;brought to medical unit of residential treatment;									Y	11/24/1998	11/24/1998	0	NONE	OTH	PVT	NONE	NONE	PCN & erythro	unk~ ()~~~In patient	WA991527	1						1	Face oedema; Rhinitis; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~06408P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0102389	02/26/1999	OH	36.0			M	10/29/1998	pt recv vax 24OCT96 & 25OCT96 exp chills, fever 102.5 & redness @ the site of vax;the redness included streaks radiating to the inner arm & axilla & lt lymphadenopathy;dx w/secondary infect @ pnu immune 23 inj site;				Y					Y	10/24/1996	10/25/1996	1		PVT	PVT	unspecified asthma medication	NONE	asthma	~ ()~~~In patient	7500	1						2	Chills; Infection; Injection site hypersensitivity; Lymphadenopathy; Pyrexia; Skin striae	FLU3~CONNAUGHT LABORATORIES~~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~438670~1~IM~LA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0102893	02/26/1999	CO	45.0			F	11/19/1998	Pt recv vax on unspecified day;  within min post vax pt exp throat & ears itchy, nausea, dizzy, throat closing, weak			Y	Y					Y					OTH	PVT	NONE	NONE	NONE		U199800259	1						4	Asthenia; Dizziness; Laryngospasm; Nausea; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81862~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~4	USA	Life Threatening	Influenza
0103034	02/26/1999	WV	7.0	7		F	10/29/1998	pt recv vax 3OCT97 & 2hr p/vax  pt exp a generalized rash;pt returned to the office for observation on 4OCT97 & was treated w/DPH w/good results;				Y					Y	10/03/1997	10/03/1997	0		UNK	UNK				~ ()~~~In patient	7526	1						2	Rash	FLU3~CONNAUGHT LABORATORIES~7F81860~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0103368	02/26/1999	TN				M	10/14/1997	Pt recv vax on 10/10/97; within 3 hr post vax pt exp fever (103F), chills, shaking & aches x 3 days									U	10/10/1997	10/10/1997	0		OTH	OTH				~ ()~~~In patient	7628	1						2	Chills; Myalgia; Pyrexia; Tremor	FLU3~CONNAUGHT LABORATORIES~7F81840~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0103400	02/26/1999	TN	56.0	56		F	07/23/1998	Pt recv vax on 10/2/97; on same day pt exp chills, shaking, body aches, weakness x 24 hr									Y	10/02/1997	10/02/1997	0		OTH	OTH				~ ()~~~In patient	7626	1						2	Asthenia; Chills; Myalgia; Tremor	FLU3~CONNAUGHT LABORATORIES~7F81840~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0103401	02/26/1999	TN	68.0	68		M	07/23/1998	Pt recv vax on 10/10/97; within 12 hr post vax pt exp shaking, chills, body aches & fever									Y	10/10/1997	10/10/1997	0		PVT	PVT				~ ()~~~In patient	7627	1						2	Chills; Myalgia; Pyrexia; Tremor	FLU3~CONNAUGHT LABORATORIES~7F81840~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0103884	02/26/1999	RI	75.0			F	11/17/1998	pt recv vax 2OCT97 & the next day pt exp an inj site rxn described as red, hot, indurated & tender;the reaction reportedly involved the upper arm, axilla & chest wall;									Y	10/02/1997	10/03/1997	1		PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient	7706	1						2	Injection site hypersensitivity; Injection site mass; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81860~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0103885	02/26/1999	RI				F	11/18/1998	pt recv vax 8OCT97 & immed p/vax pt exp a site rxn described as localized swelling, induration, redness, heat, pain & tenderness;later the pt exp heaviness of the arm & swelling to shoulder to chest wall;									Y	10/08/1997	10/08/1997	0		OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient	7707	1						2	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Myasthenic syndrome; Oedema; Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81860~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0103886	02/26/1999	RI				F	11/18/1998	pt recv vax 2OCT97 & the next day pt exp an inj site rxn described as localized swelling, induration, redness, heat pain & tenderness;									Y	10/02/1997	10/03/1997	1		OTH	UNK	NONE	NONE	NONE	~ ()~~~In patient	7708	1						2	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81860~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0103887	02/26/1999	RI				M	11/18/1998	pt recv vax 2OCT97 & the next day pt exp an inj site rxn described as localized swelling, induration, redness, heat, pain & tenderness;									Y	10/02/1997	10/03/1997	1		OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient	7709	1						2	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81860~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0103888	02/26/1999	RI				F	11/03/1997	pt recv vax 8OCT97 & about 8hr p/vax pt exp an inj site rxn described as localized swelling, redness, induration, head, pain & tenderness;									Y	10/08/1997	10/08/1997	0		OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient	7710	1						2	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81860~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0104078	02/26/1999	HI	27.0			F	11/18/1998	pt recv vax 22SEP97 & 2 days later pt exp an inj site rxn described as 3 inches in diameter, red, swollen, lumpy & painful;									Y	09/22/1997	09/24/1997	2		PUB	PVT		NONE		~ ()~~~In patient	7713	1						2	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81819~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0104079	02/26/1999	HI				F	11/18/1998	pt recv vax 22SEP97 & same day pt exp an inj site rxn described as 3 inches in diameter, red, swollen, hard & painful;also pt exp achy feelings & chills;									Y	09/22/1997	09/22/1997	0		PUB	PUB		NONE		~ ()~~~In patient	7714	1						2	Chills; Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Myalgia	FLU3~CONNAUGHT LABORATORIES~7F81819~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0104080	02/26/1999	HI	57.0			F	11/18/1998	pt recv vax 26SEP97 & the next day pt exp an inj site rxn described as 3 inches in diameter, red, swollen, lumpy & painful;									Y	09/26/1997	09/27/1997	1		PUB	PVT		NONE		~ ()~~~In patient	7716	1						2	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81819~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0104081	02/26/1999	HI	38.0			F	11/18/1998	pt recv vax 24SEP97 & next day pt exp an inj site rxn described as 3 inches in diameter, red, swollen, lumpy & painful;pt also reportedly exp hives & swelling of the entire arm;									Y	09/24/1997	09/25/1997	1		PUB	PVT		NONE	patient does have other allergies (unspecified)	~ ()~~~In patient	7715	1						2	Injection site hypersensitivity; Injection site mass; Injection site pain; Oedema peripheral; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81819~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0104082	02/26/1999	HI	46.0			F	11/18/1998	pt recv vax 25SEP97 & next day pt exp an inj site rxn described as 3 inches in diameter, red, swollen, lumpy & painful;									Y	09/25/1997	09/26/1997	1		PUB	PVT		NONE		~ ()~~~In patient	7717	1						2	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81819~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0104083	02/26/1999	HI	45.0			F	11/18/1998	pt recv vax 13OCT97 & the next day pt exp an inj site rxn described as 3 inch in diameter, red, swollen & lumpy;									Y	10/13/1997	10/14/1997	1		PUB	PVT		NONE		~ ()~~~In patient	7718	1						2	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~7F81819~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0104319	02/26/1999	AL	57.0	57		M	11/17/1998	pt recv vax 24OCT97 & 3hr p/vax pt exp hives & treated self w/DPH;later that day, pt was seen @ local physician & treated w/DPH & parenteral anti-inflammatory steroids;				Y					U	10/24/1997	10/24/1997	0		UNK	UNK				~ ()~~~In patient	7683	1						2	Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81856~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0104398	02/26/1999	MD	45.0	45		F	11/17/1998	pt recv vax 29OCT97 & during & immed p/vax pt exp tightening of throat, burning of throat & a bad taste in mouth;									Y	10/29/1997	10/29/1997	0		OTH	PVT	unk	NONE	subsequent to the adverse reaction, pt related she'd had a severe allergic rxn while receiving anesthesia;this info was not related prior to vaccination during screening (i.e., all answers were negative to questions re: allergies to eggs	~ ()~~~In patient	7695	1						2	Dysgeusia; Laryngospasm; Pain	FLU3~CONNAUGHT LABORATORIES~7F81754~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0104774	02/26/1999	NJ	42.0	42		F	11/19/1998	Pt recv vax on 10/10/97; on half hr post vax pt exp LA, back, chest, shoulder pain w/ sleeplessness; tx=physical therapy exercise									N	10/10/1997	10/10/1997	0	NONE	PUB	PUB	UNK	NONE	Hx of tendonitis in left elbow	~ ()~~~In patient	U199800212	1						2	Back pain; Chest pain; Insomnia; Pain	FLU3~CONNAUGHT LABORATORIES~7F81916~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0104808	02/26/1999	OH	37.0	37		F	11/18/1998	pt recv vax 29OCT97 & the next day pt exp itching, redness & warmth in the upper arm of the inj;pt was seen by MD & tx w/biaxin x 10 days;				Y					Y	10/29/1997	10/30/1997	1	NA	PUB	PVT		NONE	allergy to bee stings, periodic sinus problems;	~ ()~~~In patient	7782	1						2	Injection site hypersensitivity; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81917~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0104809	02/26/1999	OH	40.0	40		F	11/18/1998	pt recv vax 29OCT97 & the next day pt exp pain @ inj site & an inj site rxn described as red & warm;pt was seen by MD & dx with an infect that was treated w/duricef x 10 days;				Y					Y	10/29/1997	10/30/1997	1	NA	UNK	UNK	Estrogen	NONE	asthma	~ ()~~~In patient	7781	1						2	Infection; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81917~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0104810	02/26/1999	OH	41.0	41		F	11/18/1998	pt recv vax 19OCT97 & the next day pt exp an inj site rxn described as red & swollen;pt was seen by MD & advised to treat w/oral APAP & local cold packs;				Y					Y	10/29/1997	10/30/1997	1	NA	PUB	PVT	Verapamil	NONE	hypertensive allergic to sulfa, red food coloring	~ ()~~~In patient	7780	1						2	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~7F81820~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0105071	02/26/1999	OH	13.0	13		M	11/18/1998	pt recv vax 3NOV97 & w/in 15min of inj pt reportedly passed out & vomited & also became sleepy;5hr later subsided;pt was not seen by MD									Y	11/03/1997	11/03/1997	0		UNK	UNK				~ ()~~~In patient	7732	1						2	Somnolence; Syncope; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81917~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0105146	02/26/1999	MN	44.0	44		F	11/18/1998	Pt recv vax on 10/20/97; on 10/24/97 pt exp tired, achy, not feeling well				Y					U	10/20/1997	10/24/1997	4	WBC-low	OTH	OTH				~ ()~~~In patient	7779	1						2	Asthenia; Leukopenia; Malaise; Myalgia	FLU3~CONNAUGHT LABORATORIES~7F81771~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0105155	02/26/1999	NY	73.0	73		F	11/18/1998	pt recv vax 5NOV97 & 3hr p/vax pt exp tightening in throat;pt was not seen by MD;24NOV97 f/u reports achiness, malaise, chill, asymptomatic next morning;									Y	11/05/1997	11/05/1997	0	NONE	PVT	PVT	NONE	NONE	unk	~ ()~~~In patient	7736	1						2	Chills; Laryngospasm; Malaise; Myalgia	FLU3~CONNAUGHT LABORATORIES~7F81895~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0105225	02/26/1999	NJ	34.0	34		F	11/18/1998	pt recv vax 17NOV97 & pt c/o h/a late on 18NOV97 took  dose of generic h/a medicine & went to bed;pt awoke on 19NOV 1Am w/hives on back, stomach, neck & arms with intense itching, swollen lips & chest tightness;				Y					Y	11/17/1997	11/18/1997	1	NA	PVT	PVT	general h/a meds	NONE	unk	~ ()~~~In patient	7786	1						2	Chest pain; Face oedema; Headache; Pruritus; Urticaria; Chest pain; Face oedema; Headache; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81854~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~7F81854~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Emergency room visit	Influenza
0105225	02/26/1999	NJ	34.0	34		F	11/19/1998	Pt recv vax on 11/17/97; on 11/19/97 pt exp headache, hives on stomach, back, neck w/ itching, swollen lips, tight chest; tx=generic headache medicine				Y					N	11/17/1997	11/19/1997	2		PVT	PVT		NONE	UNK	~ ()~~~In patient	U199800213	1						3	Chest pain; Face oedema; Headache; Pruritus; Urticaria; Chest pain; Face oedema; Headache; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81854~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~7F81854~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Emergency room visit	Influenza
0105565	02/26/1999	VA	62.0	62		M	11/19/1998	Pt recv vax on 11/7/97; on same day pt exp myalgia, pruritus, vax site swelling, red & warm; tx=Benadryl, Advil, ice				Y					Y	11/07/1997	11/07/1997	0		PVT	PVT	Relafen, Cytotec	NONE	Allergic to aspirin, phenobartital, IVP dye; Pt has arthritis	~ ()~~~In patient	U199800407	1						2	Injection site hypersensitivity; Injection site oedema; Myalgia; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81916~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~445639~2~IM~RA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0105921	02/26/1999	HI	46.0	46		F	11/18/1998	Pt recv vax on 11/12/97; 15 min post vax pt exp pain down left arm to hand x 1.5 days, aching in LA, weak LA, unable to raise LA				Y					N	11/12/1997	11/12/1997	0		MIL	PVT	NONE	NONE	Allergic to Penicillin & Vibramycin	~ ()~~~In patient	7797	1						2	Hypokinesia; Myalgia; Myasthenic syndrome; Pain; Hypokinesia; Injection site pain; Myalgia; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~7F81819~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~7F81819~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Emergency room visit	Influenza
0105921	02/26/1999	HI	46.0	46		F	11/19/1998	Pt recv vax on 11/12/97; 15 min post vax pt exp pain in LA  to hand x 1.5 day, aching in LA  x approx 1 mon, weak LA, unable to raise LA above head				Y					Y	11/12/1997	11/12/1997	0		OTH	PVT		NONE	Allergic to Penicillin & Vibramycin	~ ()~~~In patient	U199800218	1						3	Hypokinesia; Myalgia; Myasthenic syndrome; Pain; Hypokinesia; Injection site pain; Myalgia; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~7F81819~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~7F81819~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Emergency room visit	Influenza
0106977	02/26/1999	NV	42.0	42		F	05/16/1998	Pt recv vax on 10/2 or 10/9/97; 1 wk post vax pt exp LA numb from vax site to fingers				Y				Y	N	10/02/1997	10/09/1997	7		OTH	OTH				~ ()~~~In patient	U199800197	1						2	Paraesthesia	FLU3~CONNAUGHT LABORATORIES~7F81799~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Disabling	Influenza
0107088	02/26/1999	PA	22.0	22		M	11/19/1998	Pt recv vax on 10/23/97; approx 2 hr post vax pt exp vision loss in right eye; dx=optic neuritis tx=IV steroids-Prednisone, eye drops				Y	Y	4			N	10/23/1997	10/23/1997	0	MRI, various medical consults	OTH	PUB				~ ()~~~In patient	U199800257	1						2	Eye disorder; Optic neuritis; Thrombosis; Visual disturbance	FLU3~CONNAUGHT LABORATORIES~7F81793~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0107151	02/26/1999	OH	57.0	57		F	11/19/1998	Pt recv vax on 11/4/97; on 11/6/97 pt exp lethargy, fatigue, fever to 1/3/98; approx 2 wk post vax pt exp lump in her breast; dx=breast cancer; tx=bilateral modified mastectomy				Y	Y	2			N	11/04/1997	11/06/1997	2	11/97: Mammogram showed lump in breast & Bloodwork; Cholesterol has been elevated since flu shot	PUB	OTH	Folic acid, Centrum Silver, Caltrate, Sulfasalazin	A cold	NONE	~ ()~~~In patient	7826	1						2	Asthenia; Breast cancer; Breast neoplasm; Hypercholesterolaemia; Pyrexia; Somnolence	FLU3~CONNAUGHT LABORATORIES~7F81916~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0107581	02/26/1999	CA	38.0	37		F	11/29/1997	pt recv vax 15NOV96 & 3DEC was seen for bronchitis tx w/med;18DEC pt seen again & c/o dizziness;26DEC collapsed;also had diarrhea;c/o vertigo;suspected viral vestibulopathy;pt claims dizziness, SOB, gagging;				Y					U	11/15/1996	12/08/1996	23	pharmacology screen revealed pt urine was positive for sympathomimetic amine, a positive opiate screen & a slsicylate level of 24.3;	UNK	UNK				~ ()~~~In patient	7137	1						2	Bronchitis; Diarrhoea; Dizziness; Dyspnoea; Hypotonia; Infection; Urine analysis abnormal; Vertigo; Vestibular disorder; Vomiting	FLU3~CONNAUGHT LABORATORIES~6F71227~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0107680	02/26/1999	WI	71.0	71		F	11/19/1998	Pt recv vax on 10/1/97; on 10/3/97 pt exp red blotches on LA & unable to use arm, muscle aches in arms, buttocks, legs & knees w/ stiffness; dx=polymyalgia rheumatica				Y					N	10/01/1997	10/03/1997	2	Tests revealed pt does not have arthritis or infection	PUB	PUB	Hydrochlorothiazide, Atenolol	NONE	NONE	NONE~ ()~~~In patient	U199800014	1						2	Arthralgia; Myalgia; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~7F81746~5~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0109233	02/26/1999	IL	51.0			F	11/19/1998	Pt recv vax on 10/30/97; on same day pt exp vax site rxn of redness & hard knot									U	10/30/1997	10/30/1997	0		OTH	OTH	NONE	NONE		~ ()~~~In patient	U199800361	1						2	Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0109675	02/26/1999	WI	47.0	47		F	11/17/1998	Pt recv vax on 10/10/97; 3 hr post vax pt exp shortness of breath &hives				Y					Y	10/10/1997	10/10/1997	0	UNK	PVT	PVT	Clonazepam, Dicyclomine, Loestrin OCP, Brethaire, Azmacort	NONE	Allergic to Sulfa, Ultram, Penicillin, NS Aid, Varapamil; possible allergy to seafood/ sauce	Pt recv Flu vax  1996, exp similar rxn~ ()~~~In patient	7643	1						2	Dyspnoea; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81776~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~443185~1~SC~RA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0110646	02/26/1999	CO	48.0	48		F	11/19/1998	Pt recv vax on 1/10/98; on 1/12/98 pt exp nocturnal muscle twitching of hand, arm, legs then entire body x 3 nights, sore vax site				Y					U	01/10/1998	01/12/1998	2		OTH	OTH				~ ()~~~In patient	U199800210	1						2	Injection site pain; Muscle twitching	FLU3~CONNAUGHT LABORATORIES~7F81898~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0114555	02/26/1999	MI	25.0	25		M	11/19/1998	Pt recv vax on 11/17/97; on 11/18/97 pt exp fever (102F), red/swollen/pain at rt arm vax site; tx=antibiotic, Medrol Dosepak, Benadryl, Tylenol				Y					Y	11/17/1997	11/18/1997	1		PVT	OTH	Prilosec	UNK	NONE	~ ()~~~In patient	U199800224	1						2	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81749~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~UNKNOWN MANUFACTURER~442526~UNK~IM~LA~PNEUMO (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0116506	02/26/1999	CA	62.0	62		F	02/25/1999	syncope 1 day p/vax, exp fever for 3 days, dizziness, malaise for 4 days & felt better.  16 days p/vax hospitalized w/ viral synd, hypokalemia, dehydrat, weakness, fever, anorexia, hypotension, post nasal drip.  dx: flu-like febrile illness					Y				Y	11/04/1998	11/05/1998	1	potassium 2.4, mild anemia after rehydration	OTH	OTH	hydrochlorothiazide	none	allergies:codeine, hypertension, syncope		MPI982007A	1						2	Condition aggravated; Dehydration; Headache; Hypokalaemia; Hypotension; Influenza; Rhinitis; Syncope	FLU3~MEDEVA PHARMA, LTD.~E20128GC~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Hospitalisation	Influenza
0119432	02/26/1999	MA	50.0	50		M	02/14/1999	arthralgias then numbness extremities & muscles weakness;					Y	4			Y	10/15/1998	10/21/1998	6	elevated CSF protein;	PVT	PVT	Glipizide;Prozac, Vasotec;Lasix;allopurinol, propulsid;motrin;		NKDA;diabetes type 2;obesity;DJD;sleep apnea;HTN	NONE~ ()~~~In patient		1						1	Arthralgia; CSF test abnormal; Guillain-Barre syndrome; Myasthenic syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0980570~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0119433	02/26/1999	WA	35.0	35		M		Pt recv vax on 10/20/98; post vax pt exp swollen/hard/painful arm from shoulder to elbow, fever (99-100)				Y					Y	10/20/1998				OTH	PVT	UNK	UNK	UNK	NONE~ ()~~~In patient		1						1	Oedema peripheral; Pain; Pyrexia; Skin nodule; Injection site mass; Injection site oedema; Injection site pain; Pyrexia	FLU3~PFIZER\WYETH~4988200~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~454383~1~IM~~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~4988200~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~454383~1~IM~~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0119499	02/26/1999	IN	62.0	62		M	10/29/1998	Pt recv vax on 12/10/96; on 10/29/98 pt exp post vax neuropathy-polyperipheral type w/ multi-limp weakness; f/u info reports pt exp first sx 10/29/96				Y	Y	3			U	12/10/1996			Pt saw neurologist, dx=immune mediated multifocal motor neuropathy w/ conductive blockage	PVT	OTH	glucotrol, neurontin	Back & leg pain	diabetes mellitus, sciatica	~ ()~~~In patient	7485	1						1	Myasthenic syndrome; Neuropathy	FLU3~CONNAUGHT LABORATORIES~6F71246~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0119500	02/26/1999	OH				F	10/01/1997	Pt recv vax on 10/1/97; within 1 min post vax pt exp throat closing, lip swelling, asthma attack w/ wheezing; tx=Epinephrine & breathing treatment			Y						Y	10/01/1997	10/01/1997	0		OTH	OTH				NONE~ ()~~~In patient	7512	1						1	Asthma; Condition aggravated; Face oedema; Laryngospasm	FLU3~CONNAUGHT LABORATORIES~7F81869~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0119501	02/26/1999	IN				F	10/09/1997	Pt recv vax on 10/7/97; approx 1 1/2 hr post vax pt exp bronchial spasms, sweats & malaise; tx=Epinephrine			Y	Y					Y	10/07/1997	10/07/1997	0		OTH	OTH				~ ()~~~In patient	7565	1						1	Asthma; Hyperhidrosis; Malaise	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0119502	02/26/1999	PA	72.0	72		F	11/13/1998	Pt recv vax on 10/10/97; on 10/11/97 pt exp red local rxn;dx=cellulitis; tx=Cipro, moist heat					Y				Y	10/10/1997	10/11/1997	1		OTH	OTH			COPD, Chronic lymphocytosis, Status post right upper lobectomy for squamous cell CA lung	~ ()~~~In patient	7630	1						1	Cellulitis; Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~7F81749~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0119503	02/26/1999	NY	6.0	6		M	11/13/1998	Pt recv vax on 10/8/97; immediately post vax pt exp asthmatic episode, rash of upper body/ face; tx=Albuterol (3), Benadryl				Y	Y	2			Y	10/08/1997	10/08/1997	0		OTH	OTH				~ ()~~~In patient	7634	1						1	Asthma; Rash	FLU3~CONNAUGHT LABORATORIES~7F81916~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0119505	02/26/1999	DC				M	11/17/1998	Pt recv vax on 10/10/97; approx 10 min post vax pt exp syncope, dyspnea, cyanosis & ashen color; dx=vasovagal response; tx=Epinephrine (IM-rt arm), CPR			Y	Y					Y	10/10/1997	10/10/1997	0		OTH	OTH				~ ()~~~In patient	7651	1						1	Cyanosis; Dyspnoea; Pallor; Syncope	FLU3~CONNAUGHT LABORATORIES~7F81890~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0119507	02/26/1999	TN	23.0	23		M	11/19/1998	Pt recv vax on 12/12/89; immediate post vax pt exp viral meningitis				Y					U	12/12/1989	12/12/1989	0	Spinal tap-meningitis	UNK	UNK					7847	1						1	Infection; Meningitis	FLU3~CONNAUGHT LABORATORIES~9J01136~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119511	02/26/1999	CA	48.0	48		M	10/29/1998	pt recv vax 15MAR97 & 3 to 4wk p/vax pt exp SOB;an allergist stated exp was possibly vaccine related;				Y					N	05/15/1997	06/07/1997	23		UNK	UNK	NONE	NONE	allergies to egg as a child	~ ()~~~In patient	7386	1						1	Dyspnoea	FLU3~CONNAUGHT LABORATORIES~6F71319~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119512	02/26/1999	CA	36.0	36		F	10/29/1998	pt recv vax 30OCT96 & sometime p/vax pt exp puffiness @ the inj site & a rash on the face & neck;since then pt thinks is developing asthma;pt is reportedly a smoker;				Y					U	10/30/1996				UNK	UNK				~ ()~~~In patient	7431	1						1	Asthma; Injection site oedema; Rash	FLU3~CONNAUGHT LABORATORIES~6F71316~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119513	02/26/1999	CA	43.0	43		F	10/29/1998	pt recv vax 24SEP97 & the next day 25SEP97 pt exp fever (unspecified), sore throat, stiff neck & nausea;									U	09/24/1997	09/25/1997	1		UNK	UNK				~ ()~~~In patient	7486	1						1	Nausea; Nuchal rigidity; Pharyngitis; Pyrexia; Cough; Myalgia; Neck pain; Nuchal rigidity; Oedema; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81753~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7F81753~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0119513	02/26/1999	CA	43.0	43		F	10/29/1998	pt recv vax 24SEP97 & the next morning pt exp fever, myalgia, sore throat & cough;pt also exp a stiff neck, described as tender & swollen;									Y	09/24/1997	09/25/1997	1		PVT	PVT	Ortho-EST 1.25MG daily	NONE	allergic rhinitis	~ ()~~~In patient	7525	1						2	Nausea; Nuchal rigidity; Pharyngitis; Pyrexia; Cough; Myalgia; Neck pain; Nuchal rigidity; Oedema; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81753~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7F81753~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0119514	02/26/1999	HI				F	10/29/1998	pt recv vax 23SEP97 & w/in 4hr of vax pt exp a local rxn, 3 inches in size that was red, hard, warm & painful;pt arm was reported as sore & APAP gave some relief;									U	09/23/1997	09/23/1997	0		UNK	UNK				~ ()~~~In patient	7491	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Myalgia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81819~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119515	02/26/1999	HI				F	10/29/1998	pt recv vax 23SEP97 & w/in 4hr of vax pt exp a local rxn (3 inches in size) that was red, hard, warm & painful;pt arm was reported as sore & APAP gave some relief;									U	09/23/1997	09/23/1997	0		UNK	UNK				~ ()~~~In patient	7492	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Myalgia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81819~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119517	02/26/1999	CA	51.0	51		F	10/01/1997	pt recv vax 30SEP97 & 10hr p/vax pt exp chills for a duration of three hr & myalgia;									U	09/30/1997	09/30/1997	0		UNK	UNK				~ ()~~~In patient	7507	1						1	Chills; Myalgia	FLU3~CONNAUGHT LABORATORIES~7F81749~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119518	02/26/1999	CT	40.0			M	10/29/1998	pt recv vax 23SEP97 & 1 or 2 days p/vax pt exp myalgia, flu-like sx, nausea & h/a;from f/u 20OCT97 it was reported, prescribed valtrex 500mg tid;pred x 2 days;									Y	09/23/1997	09/24/1997	1		UNK	UNK	NONE	NONE	NONE	~ ()~~~In patient	7508	1						1	Headache; Influenza; Myalgia; Nausea	FLU3~CONNAUGHT LABORATORIES~7F81869~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119519	02/26/1999	CT	79.0	79		M	10/29/1998	pt recv vax 23SEP97 & about 3 days p/vax pt exp h/a, nausea, body aches & lesions on the face;									Y	09/23/1997			NA	UNK	UNK				~ ()~~~In patient	7509	1						1	Headache; Myalgia; Nausea; Rash	FLU3~CONNAUGHT LABORATORIES~7F81869~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119520	02/26/1999	CT	22.0	22		M	10/29/1998	pt recv vax 23SEP97 & pt was uncertain as to when sx began but reported axillary soreness, swelling & tenderness on 29SPE97;									Y	09/23/1997	09/29/1997	6	NA	PVT	PVT	Librax 1 TID	NONE		~ ()~~~In patient	7510	1						1	Lymphadenopathy; Oedema; Pain	FLU3~CONNAUGHT LABORATORIES~7F81869~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119521	02/26/1999	GA	58.0	57		F	10/29/1998	pt recv vax 29SEP97 & the next day pt exp redness (30mm) & inflammation @ the inj site;									U	09/29/1997	09/30/1997	1		UNK	UNK					7513	1						1	Injection site hypersensitivity; Injection site inflammation	FLU3~CONNAUGHT LABORATORIES~7P81830~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119522	02/26/1999	GA	41.0	41		F	10/29/1998	pt recv vax 29SEP97 & the next day pt exp redness (60mm), swelling, warmth & inflammation @ the inj site;									U	09/29/1997	09/30/1997	1		UNK	UNK					7514	1						1	Injection site hypersensitivity; Injection site inflammation; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81830~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119523	02/26/1999	GA	43.0	43		M	10/20/1998	pt recv vax 29SEP97 & the next day pt exp site redness (30mm), swelling, warmth & inflammation;									U	09/29/1997	09/30/1997	1		UNK	UNK					7515	1						1	Injection site hypersensitivity; Injection site inflammation; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81830~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119524	02/26/1999	GA	60.0	60		F	10/29/1998	pt recv vax 29SEP97 & the next day pt exp inj site redness (60mm), swelling, warmth & inflammation;									U	09/29/1997	09/30/1997	1		UNK	UNK					7516	1						1	Injection site hypersensitivity; Injection site inflammation; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81830~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119527	02/26/1999	NH	52.0	52		M	10/29/1998	pt recv vax 1OCT97 & approx 4hr p/vax pt exp rhinitis, nausea, achiness & indigestion;									Y	10/01/1997	10/01/1997	0	NONE	OTH	UNK	Verapimal, Atenal, naproxen, Lopid, Neurontin, Glucotrol XL	NONE	diabetes;arteriosclerosis-heart disease;	~ ()~~~In patient	7537	1						1	Gastrointestinal disorder; Myalgia; Nausea; Rhinitis	FLU3~CONNAUGHT LABORATORIES~7F81854~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119528	02/26/1999	OH	32.0	32		F	10/29/1998	pt recv vax 3OCT97 & that same day pt exp h/a & flu sx consisting of congestion, backache, sinus congestion & pain;pt keeps returning to the MD office w/these complaints & the reporting MD feels that they are r/t a cold & poss sinus infect;									U	10/03/1997	10/03/1997	0		UNK	UNK				~ ()~~~In patient	7559	1						1	Back pain; Headache; Influenza; Pain; Pharyngitis; Rhinitis; Sinusitis	FLU3~CONNAUGHT LABORATORIES~7F81883~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119529	02/26/1999	CA	50.0			U	10/29/1998	pt recv vax 17SEP97 & the next day pt exp a site rxn consisting of a 3-4inch red welt, irritation & itching @ inj site;									U	09/17/1997	09/18/1997	1		UNK	UNK				~ ()~~~In patient	7560	1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81753~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119530	02/26/1999	CA	50.0			U	10/29/1998	pt recv vax 17SEP97 & the next day pt exp a site reaction consisting of a 3-4inch red welt, irritation & itching @ the site of inj;									U	09/17/1997	09/18/1997	1		UNK	UNK				~ ()~~~In patient	7561	1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81753~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119531	02/26/1999	CA	27.0			U	10/29/1998	pt recv vax 17SEP97 & the next day pt exp a site reaction consisting of a 3-4 inch red welt, irritation & itching;									U	09/17/1997	09/18/1997	1		UNK	UNK				~ ()~~~In patient	7562	1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81753~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119532	02/26/1999	CA	52.0			U	10/29/1998	pt recv vax 17SEP97 & the next day pt exp an inj site rxn consisting of a 3-4inch red welt, irritation & itching;									U	09/17/1997	09/18/1997	1		UNK	UNK				~ ()~~~In patient	7563	1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81753~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119533	02/26/1999	CA	18.0			U	10/29/1998	pt recv vax 17SEP97 & the next day pt exp an inj site rxn consisting of a 3-4 inch red welt, irritation & itching;									U	09/17/1997	09/18/1997	1		UNK	UNK				~ ()~~~In patient	7564	1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81753~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119534	02/26/1999	IL	55.0	55		F	10/29/1998	pt recv vax 8OCT97 & approx 5hr p/vax pt exp chest tightness, facial vasodilation (felt real hot) & eyes became irritated, itchy & swollen;tx w/dimetapp  & felt better p/1.5hr; Indicated that she had difficulty breathing, throat tight.									U	10/08/1997	10/08/1997	0		UNK	UNK					7573	1						1	Chest pain; Dyspnoea; Eye disorder; Face oedema; Laryngospasm; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81723~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119535	02/26/1999	PA	48.0	48		F	10/29/1998	Pt recv vax on 9/23/97; on 9/24/97 pt exp erythema at vax site				Y					Y	09/23/1997	09/24/1997	1		OTH	OTH				~ ()~~~In patient	7578	1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~7F81758~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119536	02/26/1999	PA	41.0	41		F	10/29/1998	Pt recv vax on 9/23/97; on 9/24/97 pt exp red, swollen, sore vax site									Y	09/23/1997	09/24/1997	1		OTH	OTH				~ ()~~~In patient	7579	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81758~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119537	02/26/1999	PA	30.0	30		F	10/29/1998	Pt recv vax on 9/23/97; on 9/24/97 pt exp red, swollen, warm vax site				Y					Y	09/23/1997	09/24/1997	1		OTH	OTH				~ ()~~~In patient	7580	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81758~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119538	02/26/1999	PA	43.0	43		M	10/29/1998	Pt recv vax on 9/29/97; on 9/30/97 pt exp cold sx									Y	09/29/1997	09/30/1997	1		OTH	OTH	NONE	NONE	Exercise induced asthma	~ ()~~~In patient	7581	1						1	Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~7F81758~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119539	02/26/1999	CA	53.0	53		M	01/22/1998	Pt recv vax on 10/9/97; on same day pt exp dry cough									Y	10/09/1997	10/09/1997	0	NONE	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient	7620	1						1	Cough	FLU3~CONNAUGHT LABORATORIES~7F81753~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119540	02/26/1999	PA	49.0	49		F	10/20/1997	Pt recv vax on 10/9/97; 6 min post vax pt exp hypotension, coldness, clammy sweat, almost passing out									U	10/09/1997	10/09/1997	0	BP 60/40	OTH	OTH				~ ()~~~In patient	7621	1						1	Chills; Hyperhidrosis; Hypotension; Syncope	FLU3~CONNAUGHT LABORATORIES~7F81883~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119541	02/26/1999	VA	21.0	21		F	07/23/1998	Pt recv vax on 10/9/97; 12 hr post vax pt exp fever (102F), chills, headache & body aches				Y					Y	10/09/1997	10/10/1997	1	NONE	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	7622	1						1	Chills; Headache; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81776~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119542	02/26/1999	KS	76.0	76		F	07/23/1998	Pt recv vax on 10/8/97; on 10/9/97 pt exp itchy vax site									Y	10/08/1997	10/09/1997	1	NONE	OTH	OTH	Diabetic medicine	NONE	Several allergies; Heart & liver problems	~ ()~~~In patient	7623	1						1	Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81752~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119543	02/26/1999	MN	57.0	57		F	10/14/1997	Pt recv vax on 10/9/97; on 10/11/97 pt exp red rash over body									U	10/09/1997	10/11/1997	2		OTH	OTH				~ ()~~~In patient	7625	1						1	Rash	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119547	02/26/1999	MI	49.0	49		F	11/13/1997	Pt recv vax on 10/10/97; 3 hr post vax pt exp local rxn of red, warmth, tender & induration; {12 hr post vax pt exp fever, chills, cough, runny nose, diarrhea &vomiting} x 24 hr									Y	10/10/1997	10/10/1997	0		PVT	OTH	Cozar, Prempro	NONE	Allergic to Keflex, Penicillin & metal	~ ()~~~In patient	7629	1						1	Chills; Cough; Diarrhoea; Injection site hypersensitivity; Injection site mass; Injection site pain; Pyrexia; Rhinitis; Vasodilatation; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81816~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119548	02/26/1999	WI	41.0	40		F	11/13/1998	Pt recv vax on 10/13/97; 20 min post vax pt exp hives on chest, immediately pt exp local rxn at vax site, 25 min post vax pt exp hoarse voice & dizzy; tx=ice, Benadryl				Y					Y	10/13/1997	10/13/1997	0	NONE	OTH	OTH	NONE	NONE	Allergic to Sulfa (rash), possible Demerol (local rxn of redness to arm-Epinephrine given)	~ ()~~~In patient	7631	1						1	Dizziness; Dysphonia; Injection site hypersensitivity; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81777~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119549	02/26/1999	PA	53.0	53		F	11/13/1998	Pt recv vax on 10/3/97; on same day pt exp abscess at vax site-sore, swollen & inflamed; tx=antibiotics									Y	10/03/1997	10/03/1997	0		OTH	OTH			NONE	~ ()~~~In patient	7632	1						1	Injection site abscess; Injection site inflammation; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81749~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119550	02/26/1999	TX	51.0	51		M	11/13/1998	Pt recv vax on 10/13/97; 6 hr post vax pt exp shaking chills, fever (102.2F), body aches, rigors & headache									U	10/13/1997	10/13/1997	0		OTH	OTH				~ ()~~~In patient	7635	1						1	Chills; Headache; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81852~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119551	02/26/1999	WA	52.0	52		F	11/13/1998	Pt recv vax on 10/14/97; 20 min post vax pt exp bright lights in the central & peripheral field of vision				Y					U	10/14/1997	10/14/1997	0		OTH	OTH				~ ()~~~In patient	7636	1						1	Visual field defect	FLU3~CONNAUGHT LABORATORIES~7F81854~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119552	02/26/1999	OH	70.0	70		F	11/13/1998	Pt recv vax on 10/9/97; on 10/14/97 pt exp erythema, induration & itching below vax site-LA									U	10/09/1997	10/14/1997	5		OTH	OTH				~ ()~~~In patient	7637	1						1	Injection site hypersensitivity; Injection site mass; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81742~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119553	02/26/1999	PA				F	10/16/1997	Pt recv vax on 10/9/97; on 10/10/97 pt exp malaise, myalgia, pruritus; tx=unspecified medication									U	10/09/1997	10/10/1997	1		OTH	OTH				~ ()~~~In patient	7642	1						1	Malaise; Myalgia; Pruritus	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119555	02/26/1999	KY	32.0	32		F	11/17/1998	Pt recv vax on 10/14/97; on 10/15/97 pt exp red, warm, tender vax site									U	10/14/1997	10/15/1997	1	NONE	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	7647	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81760~6~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119556	02/26/1999	DC				M	11/17/1998	Pt recv vax on 10/10/97; immediately post vax pt exp tingling in hands, feet & legs				Y					Y	10/10/1997	10/10/1997	0		OTH	OTH				~ ()~~~In patient	7650	1						1	Paraesthesia	FLU3~CONNAUGHT LABORATORIES~7F81890~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119557	02/26/1999	OH	61.0	61		F	11/17/1998	Pt recv vax on 10/14/97; on 10/15/97 pt exp fever (103F), vomiting, red/warm/sore vax site, right side flushed face				Y					U	10/14/1997	10/15/1997	1		OTH	OTH				~ ()~~~In patient	7652	1						1	Injection site hypersensitivity; Pyrexia; Vasodilatation; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81817~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119558	02/26/1999	OH	68.0	68		F	11/17/1998	Pt recv vax on 10/14/97; immediately post vax pt exp dyspnea, nausea & swollen/red/warmth area from shoulder to elbow; tx=Benadryl, Solu Medrol, Depo Medrol, Elocon cream									U	10/14/1997	10/14/1997	0		PUB	PUB	Tenorim, Premarin, Orasone, Leucovin, Methotrexate, Prednisone, Sulfa Slozime	NONE	Arthritis, Liver-benign/cipts, Cardiac arrthymias, GERD, HTN, HLP	7653~ ()~~~In patient	7653	1						1	Dyspnoea; Injection site hypersensitivity; Injection site oedema; Nausea; Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81917~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119559	02/26/1999	PA	61.0			F	11/17/1998	Pt recv vax on 10/14/97; within 15 min post vax pt exp itching, vax site red & swollen w/ erythema near site									U	10/14/1997	10/14/1997	0		OTH	OTH				~ ()~~~In patient	7654	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81802~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119560	02/26/1999	CA	57.0	57		F	11/17/1998	Pt recv vax on 10/14/97; on 10/16/97 pt exp erythema, red induration at vax site w/ cellulitis									Y	10/14/1997	10/16/1997	2		OTH	OTH		NONE		~ ()~~~In patient	7655	1						1	Cellulitis; Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~7F81753~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119561	02/26/1999	CA	52.0	52		F	11/17/1998	Pt recv vax on 10/14/97; on 10/16/97 pt exp erythema/ red/ sore vax site									Y	10/14/1997	10/16/1997	2		OTH	OTH		NONE		~ ()~~~In patient	7656	1						1	Injection site hypersensitivity; Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81753~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119562	02/26/1999	CA	59.0	58		F	11/17/1998	Pt recv vax on 10/13/97; post vax pt exp local rxn from shoulder to wrist; vax was given SC rather than IM									Y	10/13/1997	10/13/1997	0		PVT	PVT		NONE		~ ()~~~In patient	7657	1						1	Injection site reaction	FLU3~CONNAUGHT LABORATORIES~7F81862~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119563	02/26/1999	CA	38.0	38		F	11/17/1998	Pt recv vax on 10/14/97; on same day pt exp local rxn from shoulder to wrist; vax given SC rather than IM									U	10/14/1997	10/14/1997	0		PVT	PVT		NONE		~ ()~~~In patient	7658	1						1	Injection site reaction	FLU3~CONNAUGHT LABORATORIES~7F81862~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119564	02/26/1999	WI	35.0			F	10/20/1997	Pt recv vax on 10/15/97; 1 hr post vax pt exp dizziness, nausea, vomiting, sore throat &swollen neck glands				Y					U	10/15/1997	10/15/1997	0		OTH	OTH				~ ()~~~In patient	7663	1						1	Dizziness; Lymphadenopathy; Nausea; Pharyngitis; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81903~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119565	02/26/1999	MO	60.0	60		M	11/17/1998	Pt recv vax on 10/13/97; on 10/15/97 pt exp little red blisters on upper arm to armpit; tx=Caladryl									Y	10/13/1997	10/15/1997	2		OTH	PVT	NONE	NONE	Allergic to Penicillin	NONE~ ()~~~In patient	7664	1						1	Dermatitis bullous	FLU3~CONNAUGHT LABORATORIES~7F81852~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119566	02/26/1999	TN	63.0	63		F	11/17/1998	Pt recv vax on 10/15/97; on same day pt exp chills, nausea, vomiting, malaise &circumoral paresthesia, confusion, rash began at vax site to spread over body				Y					Y	10/15/1997	10/15/1997	0		OTH	OTH	Altase & a diuretic	NONE	Allergic to Penicillin & Codeine	~ ()~~~In patient	7665	1						1	Chills; Confusional state; Malaise; Nausea; Paraesthesia; Personality disorder; Rash; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81748~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119567	02/26/1999	OH	71.0	71		F	11/17/1998	Pt recv vax on 10/17/97; 15 min post vax pt exp fever, malaise, pain between shoulders, chills; on 10/18/97 pt passed out/ fever 103.8				Y					Y	10/17/1997	10/17/1997	0	10/20/97:  UBC 18.6, Urinary-UBC trace, Bacteria trace, RBC trace, Mucus trace	OTH	OTH	Proventil 2nd, Prednisone	UTI sx(UA no bacteria10/2/97),	Allergic to Biaxin, Asthma, COPD, Pain right shoulder, between shoulder blades, back, chills, incr temp, malaise, pneumoria	~ ()~~~In patient	7666	1						1	Asthenia; Back pain; Chills; Malaise; Pyrexia; Syncope	FLU3~CONNAUGHT LABORATORIES~7F81817~5~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119568	02/26/1999	WI	30.0	30		F	11/17/1998	Pt recv vax on 10/14/97; on same day pt exp fever (102.8F), chills, shakes & headache									Y	10/14/1997	10/14/1997	0	NONE	PUB	PVT	NONE	NONE	Allergic to Amoxicillin	~ ()~~~In patient	7667	1						1	Chills; Headache; Pyrexia; Tremor	FLU3~CONNAUGHT LABORATORIES~7F81750~4~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119569	02/26/1999	NY	8.0	8		M	11/17/1998	Pt recv vax on 10/14/97; immediately post vax pt exp red, swollen vax site w/ pain; 1 wk post vax pt exp discolored vax sited w/ warmth; tx=Benadryl									Y	10/14/1997	10/14/1997	0	NONE	OTH	OTH	Weekly allergy shots	NONE	Allergic to dust mites & roaches	NONE~ ()~~~In patient	7670	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Skin discolouration; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81916~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119570	02/26/1999	MA	46.0	46		M	11/17/1998	Pt recv vax on 10/16/97; on 10/19/97 pt exp neuralgia from back of hand up the forearm to shoulder. From follow-up information received on August 3, 1999, it was reported that the patient recovered from this experience, Symptoms likely due to coincidental slipped disk, positive MRI.									Y	10/16/1997	10/19/1997	3	Positive MRI	UNK	UNK					7671	1						1	Intervertebral disc protrusion; Neuralgia; Nuclear magnetic resonance imaging abnormal	FLU3~CONNAUGHT LABORATORIES~7F81896~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119571	02/26/1999	PA	72.0			M	11/17/1998	Pt recv vax on 10/17/97; on same day pt exp fever, chills, malaise; tx=Motrin									Y	10/17/1997	10/17/1997	0		OTH	OTH				~ ()~~~In patient	7672	1						1	Chills; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81883~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119572	02/26/1999	NH	28.0			M	11/17/1998	Pt recv vax on 10/1/97; on 10/2/97 pt exp fever (102F), chills, diaphoresis, headache, muscle aches									Y	10/01/1997	10/02/1997	1		OTH	OTH		NONE	NONE	~ ()~~~In patient	7673	1						1	Chills; Headache; Hyperhidrosis; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81854~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119573	02/26/1999	WI	30.0	30		F	11/17/1998	Pt recv vax on 10/14/97; on same day pt exp fever, nausea, headache, cold feeling; tx=non-aspirin reliever									Y	10/14/1997	10/14/1997	0		OTH	OTH			Glycogen storage disease-Cori III malabsorption of 1, 6, starch branch	~ ()~~~In patient	7674	1						1	Chills; Headache; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81750~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119574	02/26/1999	CA	52.0	52		F	11/17/1998	pt recv vax 16OCT97 & approx 24hr p/vax pt exp a rash that resembled mosquito bites on elbows;subsequently this rash turned into hives;pt was seen in ER & treated w/atarax & steroids;				Y					U	10/16/1997	10/17/1997	1		UNK	UNK				~ ()~~~In patient	7676	1						1	Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81734~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119575	02/26/1999	AZ	38.0	38		F	11/17/1998	pt recv vax 21OCT97 4 to 5hr p/vax pt exp photophobia, h/a, stiff neck, generalized myalgia;also the pt has a rash on face that extends across nose, is palpable but does not itch;									Y	10/21/1997	10/21/1997	0		OTH	PVT			cannot state w/certainty that has vaccine from Connaught but has had vaccine every year for 5-6years w/o incident;	~ ()~~~In patient	7678	1						1	Headache; Myalgia; Nuchal rigidity; Photophobia; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~7F81750~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119577	02/26/1999	MD	47.0	46		F	07/29/1998	pt recv vax 23OCT97 & later that same day pt exp 2 inches hives, itching, redness & warmth @ inj site;pt also exp some wheezing;wheezing relieve by proventil inhaler;hives relieved by DPH;itching & 2 lump remained x 3 days a/resolving;									Y	10/23/1997	10/23/1997	0	NONE	OTH	OTH	Cozar, allergy inject q 2wk for environmental allergies, proventil 2 puffs prior to exercise;		environmental allergies, adverse reaction to clariten, evtex LA;no known allergy to eggs;	~ ()~~~In patient	7684	1						1	Asthma; Condition aggravated; Injection site hypersensitivity; Injection site mass; Pruritus; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81742~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119578	02/26/1999	TX	18.0	18		M	11/17/1998	pt recv vax 23OCT97 & about 3hr p/vax pt exp malaise & myalgia described as just not feeling right & a little achy;									U	10/23/1997	10/23/1997	0		UNK	UNK				~ ()~~~In patient	7686	1						1	Malaise; Myalgia	FLU3~CONNAUGHT LABORATORIES~7F81818~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119579	02/26/1999	WI	50.0	50		F	11/17/1998	pt recv vax 28OCT97 & that same day pt exp an inj site rxn 8.5cm x5x4cm in size & described as red, warm, hard & tender;24NOV97 f/u rash-like in appearance;site itchy;									Y	10/28/1997	10/28/1997	0	NONE	PVT	PVT	Mantoux test aplisol PPD by Parke Davis lot# 00917 given 28OCT97;Premarin	NONE	hx seasonal hay fever type allergies but never had MD dx is sensitive to thimerasolin eye products;	~ ()~~~In patient	7691	1						1	Injection site hypersensitivity; Injection site mass; Pain; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81884~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119580	02/26/1999	TX	37.0	37		M	11/17/1998	pt recv vax 27OCT97 & that same day pt exp chemical phlebitis;									U	10/27/1997	10/27/1997	0		UNK	UNK				~ ()~~~In patient	7692	1						1	Phlebitis	FLU3~CONNAUGHT LABORATORIES~7F81741~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119581	02/26/1999	NJ	49.0			F	11/17/1998	pt recv vax 30OCT97 & 5min p/vax pt exp h/a;10min p/vax pt exp nausea;40min p/pt exp sniffling & congestion;tx consisted of APAP & fluids;									Y	10/30/1997	10/30/1997	0		UNK	UNK				~ ()~~~In patient	7693	1						1	Headache; Nausea; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~7F81916~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119582	02/26/1999	TN	64.0	64		F	11/17/1998	pt recv vax 27OCT97 & 29OCT97 pt exp an inj site rxn described as red & bruised;									U	10/27/1997	10/29/1997	2		UNK	UNK				~ ()~~~In patient	7694	1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~7F81816~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119584	02/26/1999	KS	30.0	30		M	11/17/1998	pt recv vax 29OCT97 & 30min p/vax pt exp generalized hives w/o any other sx;tx consisted of DPH given @ MD office;				Y					Y	10/29/1997	10/29/1997	0	NONE	PUB	PVT	DPH cream to stop the itching;	NONE	NONE	~ ()~~~In patient	7696	1						1	Urticaria; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81896~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7F81896~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0119584	02/26/1999	KS	30.0	30		M	07/30/1998	pt recv vax 29OCT97 & that same day pt exp a rash & hives;				Y					Y	10/29/1997	10/29/1997	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	7748	1						2	Urticaria; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81896~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7F81896~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0119585	02/26/1999	MN	49.0	49		M	11/17/1998	pt recv vax 15OCT97 & the next day pt exp a generalized rash;pt had one episode of nausea & dizziness while had the rash;the episode lasted 15min;				Y					Y	10/15/1997	10/16/1997	1	CBC, sed rate	PVT	PVT	Ibuprofen 15OCT	NONE	NONE	~ ()~~~In patient	7697	1						1	Dizziness; Nausea; Rash	FLU3~CONNAUGHT LABORATORIES~7F81740~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119586	02/26/1999	ID				U	11/17/1998	pt recv vax 21OCT97 & that same day pt exp an inj site rxn described as red, swollen, hot to touch from elbow to shoulder;									Y	10/21/1997	10/21/1997	0		UNK	UNK				~ ()~~~In patient	7698	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81840~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119593	02/26/1999	CT	82.0			F	11/18/1998	pt recv vax 20OCT97 & 3 days later, pt exp inj site rxn described as redness @ the site;									Y	10/20/1997	10/23/1997	3		PVT	PUB	Zocor, ASA	NONE	NONE	~ ()~~~In patient	7712	1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~7F81854~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0906F~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0119600	02/26/1999	OH	64.0	64		F	11/18/1998	pt recv vax 28OCT97 & next day pt exp fever 103, nausea, general malaise & h/a;									U	10/28/1997	10/29/1997	1		UNK	UNK				~ ()~~~In patient	7719	1						1	Headache; Malaise; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81754~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119601	02/26/1999	OH				M	11/18/1998	pt recv vax 28OCT97 & that same day pt exp fever 103;									U	10/28/1997	10/28/1997	0		UNK	UNK				~ ()~~~In patient	7720	1						1	Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81754~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119602	02/26/1999	IL	61.0	61		F	11/18/1998	pt recv vax 25OCT97 & w/in 1hr pt had diff breathing & hives down both arms;treated w/atarax, DPH & parenteral pred in ER & hives resolved;26OCT pt exp weakness & generalized muscle spasms;				Y					U	10/25/1997	10/25/1997	0		UNK	UNK			allergic to bees, sulfa & PCN	~ ()~~~In patient	7721	1						1	Asthenia; Dyspnoea; Hypertonia; Urticaria	FLU3~CONNAUGHT LABORATORIES~~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119603	02/26/1999	TX	76.0	76		M	07/30/1998	pt recv vax 27OCT97 & the next day pt exp fever 101 & severe frontal h/a;labs showed that sed rate was increased;pt was treated w/Medrol. From follow-up of December 5, 1997 it was reported, Four days later, headaches subsided then reoccurred six days after onset and last dose of MEDROL (4 mg) - Prednisone 40mg/day - then dose of Prednisone increased to 60 mg - Headache stopped. Prednisone has been decreased in dosage and now off entirely. Headache has not reoccurred. Patient will probably have Temporal Artery biopsy soon. Reportedly the patient recovered from this experience.									Y	10/27/1997	10/28/1997	1	MRI, normal;CT of head, normal;sed rate 70;68;87;ANA 80	PVT	PVT	Lotrel 5/2:, vitamin C; E, antioxidants, pravachol, metamucil, vicodin;	vascular HTN	NONE		7722	1						1	Antinuclear antibody positive; Biopsy artery; Computerised tomogram normal; Headache; Nuclear magnetic resonance imaging normal; Pyrexia; Red blood cell sedimentation rate increased; White blood cell count normal	FLU3~CONNAUGHT LABORATORIES~7F81755~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119604	02/26/1999	CA	43.0	43		M	11/18/1998	pt recv vax 3NOV97 & that same day pt exp hives & swelling over the neck, arms, axilla;26NOV97 f/u tx w/EPI & DPH;had good results from EPI but hives returned about 2hr later;told to cont DPH;									Y	11/03/1997	11/03/1997	0	NONE	PVT	PVT	synthroid	pharyngitis	aEFPY; reported as non last recv flu vax in NOV96	~ ()~~~In patient	7723	1						1	Oedema; Oedema peripheral; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81754~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119606	02/26/1999	NY	35.0	35		F	11/18/1998	pt recv vax 28OCT97 & 2 days later pt exp swollen glands in the neck extending to the thyroid;the duration of the exp was 4 days;pt negative for mumps or thyroid disease, etc;				Y					Y	10/28/1997	10/30/1997	2	bloodwork to r/u mumps	OTH	PVT	Synthroid, Buspar, st john's wart	NONE	allergies, low grade asthma;	~ ()~~~In patient	7733	1						1	Lymphadenopathy	FLU3~CONNAUGHT LABORATORIES~7F81832~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119608	02/26/1999	LA				F	11/18/1998	pt recv vax 13OCT97 & 27OCT97 pt exp an exacerbation of herpes zoster described as an orange peel texture on the rt arm;pt was seen by MD on 5NOV97 w/no definite dx reported;				Y					U	10/13/1997	10/27/1997	14		UNK	UNK				~ ()~~~In patient	7738	1						1	Condition aggravated; Herpes zoster; Skin disorder	FLU3~CONNAUGHT LABORATORIES~7F81818~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119609	02/26/1999	CO	6.0	6		M	11/18/1998	pt recv vax 5NOV97 & over 6&7NOV97 pt exp erythema & induration of the upper arm;									Y	11/05/1997	11/06/1997	1		PVT	UNK		asthma		~ ()~~~In patient	7741	1						1	Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~7F81898~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119610	02/26/1999	CA	69.0	69		F	11/18/1998	pt recv vax NOV97 & felt hot, lightheaded & had a pre-syncope event;BP went down to 110/60;									U	11/01/1997				UNK	UNK				~ ()~~~In patient	7742	1						1	Dizziness; Hypotension; Syncope; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81898~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119611	02/26/1999	CA	41.0	41		F	11/18/1998	pt recv vax 7NOV97 & 3hr p/vax pt exp dizziness, then hands swelled, felt prickly (like asleep) & both hands are bright red;									U	11/07/1997	11/07/1997	0		UNK	UNK					7743	1						1	Dizziness; Erythema; Paraesthesia; Swelling	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119612	02/26/1999	MA				F	11/18/1998	pt recv vax 5NOV97 & w/in 1 to 2hr pt exp pain @ the inj site;pt also exp a sore throat & earache that subsided p/24hr;									U	11/05/1997	11/05/1997	0		UNK	UNK				~ ()~~~In patient	7744	1						1	Ear pain; Injection site pain; Pharyngitis; Ear pain; Injection site pain; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~7F81818~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7F81818~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0119612	02/26/1999	MA	50.0	50		F	11/18/1998	pt recv vax 5NOV97 1hr p/vax pt exp pain @ inj site;pt also exp sore throat & an earache that lasted for the rest of workday;									Y	11/05/1997	11/05/1997	0		UNK	UNK				~ ()~~~In patient	7746	1						2	Ear pain; Injection site pain; Pharyngitis; Ear pain; Injection site pain; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~7F81818~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~7F81818~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0119613	02/26/1999	GA	31.0			F	11/18/1998	4hr p/vax pt exp chest tightness, light-headedness, nausea, loose bowels;pt also exp a site rxn described as silver dollar sized that was red, hot & white around the periphery;fever, chills, sweating, worsening of gastrointestinal sx, belch									U	10/29/1997	10/29/1997	0		UNK	UNK				~ ()~~~In patient	7745	1						1	Chest pain; Chills; Diarrhoea; Dizziness; Eructation; Flatulence; Gastrointestinal disorder; Hyperhidrosis; Infection; Injection site hypersensitivity; Nausea; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~7F81791~UNK~L~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119616	02/26/1999	IL	13.0	13		F	11/18/1998	pt recv vax 11NOV97 & 6hr p/vax pt exp a very swollen arm;the next day pt exp chest pain, tremendous swelling in the arm over the deltoid & shoulder area, tenderness & myalgia;									Y	11/11/1997	11/11/1997	0	NONE	UNK	UNK	NONE	NONE	asthma, prev flu doses on 14NOV96, 7OCT94, 9NOV93, 21OCT92, 27NOV92;	~ ()~~~In patient	7751	1						1	Chest pain; Influenza; Myalgia; Oedema peripheral; Pain	FLU3~CONNAUGHT LABORATORIES~7F81852~6~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119622	02/26/1999	CA	14.0	14		F	08/03/1998	pt recv vax 17OCT97 & the next day pt was unable to lift the lt arm (vaccination side);this has persisted to the time of the 14NOV97;dx lt upper trunk brachial plexus injury which had been improving @ that time;									U	10/17/1997	10/18/1997	1		PVT	PVT				~ ()~~~In patient	7764	1						1	Hypokinesia; Neuropathy	FLU3~CONNAUGHT LABORATORIES~7F81750~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119623	02/26/1999	IN	73.0			F	11/18/1998	pt recv vax 13NOV97 & about 36hr p/vax pt exp unilateral hearing loss (70% left ear), slowed speech & malaise;first impressions were that pt had suffered a small stroke however MRI was reported as WNL;				Y					U	11/13/1997	11/15/1997	2		UNK	UNK				~ ()~~~In patient	7777	1						1	Deafness; Malaise; Speech disorder	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119624	02/26/1999	TN	4.0	4		M	11/18/1998	pt recv vax 10NOV97 & that same day pt exp fever to 103, pain & a site rxn on the thigh described as red & swollen;pt was treated w/APAP & cold compresses;									Y	11/10/1997	11/10/1997	0		UNK	UNK			child has cancer, but is not currently being treated;	~ ()~~~In patient	7778	1						1	Injection site hypersensitivity; Injection site oedema; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81840~UNK~L~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119626	02/26/1999	CT	39.0	39		M	11/19/1998	pt recv vax 12NOV97 & approx 1wk later pt exp visual disturbances & a narrowed field of vision;clinical exam reported were remarkable for inflammation of the optic nerve;				Y					U	11/12/1997	11/19/1997	7		UNK	UNK				~ ()~~~In patient	7799	1						1	Visual disturbance; Visual field defect	FLU3~CONNAUGHT LABORATORIES~7F81863~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119627	02/26/1999	AZ	41.0	41		F	11/19/1998	pt recv vax OCT91 & about 3 days p/vax pt had a soft spot in the lt arm that caused pt to have loss of ROM;pt said that med caused rxn @ the innervation point of the nerve & muscle;pain;				Y					U	10/01/1991				UNK	UNK				~ ()~~~In patient	7834	1						1	Hypokinesia; Pain	FLU3~CONNAUGHT LABORATORIES~1J21108~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119630	02/26/1999	IN	22.0	22		M	11/18/1998	pt recv vax 5NOV97 & the next morning pt exp hives on upper eyelid & both feet;7NOV97 pt was examined by a MD & found to have a rash on thorax that pt was stated was urticarial wheal prior to office visit;				Y					Y	11/05/1997	11/06/1997	1	NONE	OTH	OTH	NONE	NONE	RY hx-cats, strawberries, PCN	~ ()~~~In patient	7785	1						1	Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81771~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119632	02/26/1999	NC	34.0	34		F	08/04/1998	pt recv vax 20NOV97 & 2hr p/vax pt exp pain in the shoulder;8hr p/vax pt awoke w/lips, nose & eyes very swollen;exp diff annunciating words, chest felt very heavy d/t swelling, asthma type feeling-coughing, sl SOB, tightness;				Y	Y	1			U	11/20/1997	11/21/1997	1	C4 drawn @ later date 10DEC, RASt test 10DEC;	PVT	UNK	Pred was prescribed as a taper;	NONE	allergies to: trees, dust, plantin, ragweed, feathers, dogs & cats;	~ ()~~~In patient	7787	1						1	Asthma; Chest pain; Cough; Dyspnoea; Face oedema; Oedema; Pain	FLU3~CONNAUGHT LABORATORIES~7F81754~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0119634	02/26/1999	CO				F	11/19/1998	Pt recv vax on 10/29/97; on 10/31/97 pt exp hives, joint swelling, nausea									U	10/29/1997	10/31/1997	2		OTH	OTH				~ ()~~~In patient	U199800002	1						1	Nausea; Osteoarthritis; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81747~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119635	02/26/1999	CO	35.0	35		F	11/19/1998	Pt recv vax on 11/1/97; on 11/2/97 pt exp hives on arm, throat swelling & burning, itchy eyes									U	11/01/1997	11/02/1997	1		OTH	OTH				~ ()~~~In patient	U199800003	1						1	Laryngospasm; Pain; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~7F81749~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119636	02/26/1999	IL	13.0	13		F	11/19/1998	Pt recv vax on 11/20/97; approx 5 wk post vax pt developed asthma				Y					U	11/20/1997	12/01/1997	11		OTH	OTH				~ ()~~~In patient	U199800007	1						1	Asthma	FLU3~CONNAUGHT LABORATORIES~7F81723~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119638	02/26/1999	NY	3.0	3		M	11/19/1998	Pt recv vax on 10/30/97; on same day pt exp fever (102F), dec appetite, dizzy, vomiting & diarrhea; pt imp in 2 days				Y					Y	10/30/1997	10/30/1997	0		OTH	OTH				~ ()~~~In patient	U199800004	1						1	Anorexia; Diarrhoea; Dizziness; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~7F81916~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119639	02/26/1999	TX	40.0			F	11/19/1998	Pt recv vax on 11/12/97; on 11/13/97 pt exp rash on neck & vax site, throat closed; tx=Benadryl On 11/13, Morning after FLUZONE, when patient showered she developed a rash just on neck, then at site of vaccine.  Throat started to close about 3:30pm, 24 hours later.  Went to Emergency Room.  They gave BENADRYL and resolved.  She was monitored there for 4 hours.  No additional information was provided from correspondence received at agency on 20-Apr-200.  This case is closed.				Y					Y	11/12/1997	11/13/1997	1		UNK	UNK					U199800198	1						1	Injection site hypersensitivity; Laryngospasm; Rash	FLU3~CONNAUGHT LABORATORIES~7F81770~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119640	02/26/1999	CO	52.0	52		M	11/19/1998	Pt recv vax on 11/24/97; within 1 wk post vax pt exp myalgia, sweats & hepatitis									U	11/24/1997	11/30/1997	6		OTH	OTH				~ ()~~~In patient	U199800008	1						1	Hepatitis; Hyperhidrosis; Myalgia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119641	02/26/1999	CT	9.0	9		M	11/19/1998	Pt recv vax on 10/9/96; on 10/10/96 pt exp hives on trunk & extremities x 48 hr; tx=Benadryl									Y	10/09/1996	10/10/1996	1	NONE	PVT	PVT		NONE	NONE	~ ()~~~In patient	U199800013	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~6F71246~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119643	02/26/1999	FL	54.0	54		F	11/19/1998	Pt recv vax on 1/21/98; on 1/22/98 pt exp pain & swelling of knee, elbow & wrist									N	01/21/1998	01/22/1998	1		PUB	PUB	Synthroid, Estrogen patch	NONE	Menopause	~ ()~~~In patient	U199800037	1						1	Arthritis; Osteoarthritis	FLU3~CONNAUGHT LABORATORIES~7F81916~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119644	02/26/1999	PA	53.0	53		F	11/19/1998	Pt recv vax on 11/3/97; over last 3 mon pt exp more local pain & tenderness									Y	11/03/1997			NONE	OTH	PVT	UNK	UNK	Fibromyalgia	~ ()~~~In patient	U199800089	1						1	Condition aggravated; Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~7F81895~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119645	02/26/1999	CA	41.0	41		M	11/19/1998	Pt recv vax on 12/1/97; approx 12/10/97 pt exp brachial neuritis, pain at vax site-LA; weak left hand									N	12/01/1997	12/10/1997	9	EMG-confirms brachial neuritis	PVT	OTH	NONE	NONE	Sciatica	~ ()~~~In patient	U199800106	1						1	Injection site pain; Myasthenic syndrome; Neuritis	FLU3~CONNAUGHT LABORATORIES~49788167~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119646	02/26/1999	NH	59.0	59		F	11/19/1998	Pt recv vax on 11/13/97; on 11/20/97 pt exp red, raised area of vax site-LA									U	11/13/1997	11/20/1997	7		OTH	OTH				~ ()~~~In patient	U199800200	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~7F81930~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119647	02/26/1999	PA	53.0	53		F	11/19/1998	Pt recv vax on 12/1/97; on same day pt exp local rxn of redness, swelling & soreness									Y	12/01/1997	12/01/1997	0		OTH	OTH				~ ()~~~In patient	U199800201	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~7F81740~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119648	02/26/1999	NY	44.0	44		F	05/18/1998	Pt recv vax on 11/13/97; post vax pt exp tight, hoarse, sore throat									U	11/13/1997				OTH	OTH			Pt may be allergic to gelatin component in flu vax	Pt recv Fluzone 11/3/93, exp tight chest&hoarse voice~ ()~~~In patient	U199800199	1						1	Dysphonia; Hypertonia; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~7F81817~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119649	02/26/1999	OH	57.0	57		F	06/09/1998	Pt recv vax on 10/21/97; 3-4 wk post vax pt exp lumps in her breast				Y					U	10/21/1997	11/01/1997	11	Pt refered to specialist	OTH	OTH				~ ()~~~In patient	U199800205	1						1	Breast neoplasm	FLU3~CONNAUGHT LABORATORIES~7F81904~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~7E91657~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0119650	02/26/1999	FL				F	11/19/1998	Pt recv vax on unspecified day; within 6 wk post vax pt dx=Bell's Palsy				Y					U					OTH	OTH				~ ()~~~In patient	U199800207	1						1	Facial palsy	FLU3~CONNAUGHT LABORATORIES~7F81757~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119651	02/26/1999	OR	46.0	46		M	11/19/1998	Pt recv vax on 11/11/97; on 11/13/97 pt exp falling down, fever, sore throat, soreness, headache, backache, neck pain, dizzy; tx=Antivert				Y					Y	11/11/1997	11/13/1997	2	NONE	PVT	PVT		NONE	Back pain, incr blood pressure	~ ()~~~In patient	U199800203	1						1	Back pain; Dizziness; Headache; Hypotonia; Neck pain; Pain; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81898~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119652	02/26/1999	CO				F	05/19/1998	Pt recv vax on unknown day; 10 min post vax pt exp itchy ears & throat, nausea, dizzy, weak, positive result of Fluzone; tx=steroids Anaphylactoid reaction consisting of itchy ears and throat itching, nausea, dizziness and weak. Treated with steroids at ER. Occurred within 10 min. this Dr saw her on Oct 15th. As a follow-up allergist. Not egg allergic, did test with a different lot of FLUZONE and she had a 100mm positive result. From follow-up correspondence received at Manufacturer on 25-Apr-2000, it was reported thta the patient recovered from this experience. This case is closed.				Y					Y				Pt seen by allergist-no egg allergy, Fluzone tests-100mm positve	OTH	PUB					U199800204	1						1	Asthenia; Dizziness; Ear disorder; Nausea; Pruritus	FLU3~CONNAUGHT LABORATORIES~7F81862~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119653	02/26/1999	FL				M	11/19/1998	Pt recv vax on unknown day; within 1 month post vax pt dx=Bell's Palsy				Y					U					OTH	OTH				~ ()~~~In patient	U199800208	1						1	Facial palsy	FLU3~CONNAUGHT LABORATORIES~7F81757~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119654	02/26/1999	CT				U	11/19/1998	Pt recv vax on unknown day; 3 days post vax pt exp swelling of supraclavicular lymph nodes; pt imp approx 1 wk				Y					Y					OTH	OTH				~ ()~~~In patient	U199800206	1						1	Lymphadenopathy	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119655	02/26/1999	FL	54.0	54		F	11/19/1998	Pt recv vax in 12/97; 1-2 days post vax pt exp swollen vax site, fever (104F) w/ shaking chills									U	12/01/1997				OTH	OTH				~ ()~~~In patient	U199800209	1						1	Chills; Injection site oedema; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119658	02/26/1999	IN				U	11/19/1998	Pt recv vax on unknown day; post vax pt exp lightheadedness & dizzy									U					OTH	OTH				~ ()~~~In patient	U199800219	1						1	Dizziness	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119659	02/26/1999	AZ				F	11/19/1998	Pt recv vax on 11/8/97; 1 month post vax pt exp nausea, hurting all over, violently ill, pain in upper arm, weight loss (5lbs), unable to eat solid foods} x 1 month, malaise continues w/ diarrhea				Y					U	11/08/1997	12/08/1997	30		OTH	OTH				~ ()~~~In patient	U199800211	1						1	Diarrhoea; Injection site pain; Malaise; Myalgia; Nausea; Pain; Weight decreased	FLU3~CONNAUGHT LABORATORIES~~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119660	02/26/1999	IN				U	11/19/1998	Pt recv vax on unknown day; within 1 mon post vax pt exp lightheadedness & dizzy									U					OTH	OTH				~ ()~~~In patient	U199800220	1						1	Dizziness	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119662	02/26/1999	CA				M	11/19/1998	Pt recv vax on 12/6/97; on 12/16/97 pt exp brachial neuritis, pain at vax site-LA				Y					U	12/06/1997	12/16/1997	10	EMG-confirmed brachial neuritis	PVT	PVT		NONE	NONE	~ ()~~~In patient	U199800215	1						1	Injection site pain; Neuritis	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119663	02/26/1999	WI	53.0	53		F	11/19/1998	Pt recv vax on 10/29/97; 5 min post vax pt exp faint feeling, dry &thick tongue, heart racing, dry mouth, hypertension; tx=Benadryl				Y					N	10/29/1997	10/29/1997	0	Blood pressure at rx-170/100; Pt seen by allergist-sensitivity to eggs (hives)	PUB	PVT	Antihypertensive	NONE	Hypertension	~ ()~~~In patient	U199800216	1						1	Dermatitis exfoliative; Dry mouth; Hypersensitivity; Hypertension; Pain; Syncope; Tachycardia; Tongue disorder	FLU3~CONNAUGHT LABORATORIES~7F81840~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119664	02/26/1999	AZ				M	05/19/1998	Pt recv vax on unknown day; post vax pt exp burning & itching over body, night sweating episodes x 5 min, vax site pain/ warmth; tx=Hydroxyzine which magnifies burning & itching				Y					U					OTH	OTH				~ ()~~~In patient	U199800217	1						1	Hyperhidrosis; Injection site pain; Pain; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119666	02/26/1999	IN				U	11/19/1998	Pt recv vax on unknown day; post vax pt exp malaise									U					OTH	OTH				~ ()~~~In patient	U199800222	1						1	Malaise	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119667	02/26/1999	NC	52.0	52		M	11/19/1998	Pt recv vax on 11/10/97; in 12/97 pt exp cardiomyopathy									U	11/10/1997	12/01/1997	21		OTH	OTH	Atenolol	NONE	Hypertension	~ ()~~~In patient	U199800273	1						1	Cardiomyopathy	FLU3~CONNAUGHT LABORATORIES~7F81854~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119668	02/26/1999	MN	48.0	48		F	05/19/1998	Pt recv vax on 10/27/97; 5 min post vax pt exp wrist pain; on 10/29/97 pt exp muscle pain, numb extremities, burning in legs, joint pain									N	10/27/1997	10/27/1997	0	Complete metabolic panel, UA, CBC, TSH & Adolase & FANA	PVT	PVT			Mitral valve prolapse, Allergic to eye contact solution & sulfa	~ ()~~~In patient	U199800221	1						1	Arthralgia; Hypertonia; Myalgia; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~7F81856~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119669	02/26/1999	WA	38.0	38		M	05/20/1998	Pt recv vax on 10/9/97; 3 days post vax pt exp tricep muscle sore, weakness w/ arm abduction, tender LA									U	10/09/1997	10/12/1997	3		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	U199800223	1						1	Myalgia; Myasthenic syndrome; Pain	FLU3~CONNAUGHT LABORATORIES~7F81736~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119671	02/26/1999	MD	49.0	49		F	06/04/1998	Pt recv vax on 10/24/97; on 10/25/97 pt exp red/ aching upper LA, stiff LA to left upper back & left side neck, unable to lift LA				Y					U	10/24/1997			NONE	PUB	PUB		NONE	Allergic to Novacaine, nitrous oxide	~ ()~~~In patient	U199800271	1						1	Back pain; Hypertonia; Hypokinesia; Injection site hypersensitivity; Injection site pain; Myalgia; Myasthenic syndrome; Neck pain	FLU3~CONNAUGHT LABORATORIES~7F81791~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119700	03/03/1999	AK	33.0	33		M	02/23/1999	large local rxn w/in 12hr;malaise, arthralgias, nausea w/in 24hr;eval + skin test reactivity @ 1:100 w/u;				Y					Y	02/23/1999	02/23/1999	0		MIL	MIL				~ ()~~~In patient		1						1	Arthralgia; Injection site reaction; Malaise; Nausea; Skin disorder	FLU3~PFIZER\WYETH~4988247~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0119707	03/03/1999	MN	10.0	10		F		7hr p/vax shooting pain in lt arm, both legs & eyes;				Y					Y	11/05/1998	11/05/1998	0		PVT	PVT		nasal congestion had finished ATB for sinusitis	NONE	pt sibling exp pain @ age 7 w/MMR #2 & influenza #1~ ()~~~In Sibling		1						1	Pain	FLUX~UNKNOWN MANUFACTURER~0988300~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~1186H~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0119708	03/03/1999	MN	38.0	38		F	11/05/1998	red arm;warm arm;swollen arm;itch 4+;soreness;				Y						11/04/1998	11/04/1998	0		PVT	UNK	Flovent;Serevent	NONE	allergy to peaches, apricots, plums;	pt exp vomit, fever @ age 21 w/flu vax;~ ()~~~In patient		1						1	Myalgia; Oedema peripheral; Pneumonia; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0983290~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454979~1~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0119717	03/03/1999	MN	42.0	42		F	11/06/1998	flu type symptom;general body pain, diarrhea;pt not seen;illness lasted about 8hr;									Y	10/28/1998	10/28/1998	0		PVT	PVT		NONE	allergies (Ragweed TGW, dust,dog), lymphoma;	pt exp flu typs sx, body pain, diarrhea 2yr ago w/flu vax;~ ()~~~In patient		1						1	Diarrhoea; Influenza; Pain	FLU3~CONNAUGHT LABORATORIES~0968420~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0119730	03/03/1999	WI	55.0	55		F	02/25/1999	aseptic meningitis;h/a, n/v, fatigue, weight loss;									N	12/28/1998	12/29/1998	1	LP negative cytology, WBC 7, protein 107, negative CXS;negative head MRI	PVT	PVT	Zoloft;Prempro	NONE	pollen, dust	~ ()~~~In patient		1						1	Asthenia; CSF test abnormal; Headache; Meningitis; Vomiting; Weight decreased	FLU3~MEDEVA PHARMA, LTD.~E20218HA~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0114487	03/05/1999	NY	81.0	81		F	02/24/1999	recv vax 10/27/97, devel partial deafness the next day. Considered a disability, began wearing a hearing aid which she states as not helpful.								Y	N	10/27/1997	10/28/1997	1	8APR98 MRI scan of brain & internal auditory canals revealed moderate cerebral atrophy manifested by ventricular & sulcal prominence;sinus disease prominent in lt maxillary & ethmoid sinuses;polyp or retention cyst in rt maxillary sinus	PVT	OTH	L-Thyroxin, Calan	unk	unk	~ ()~~~In patient	0010150990001	1						2	Cerebrovascular disorder; Cyst; Deafness permanent; Ear disorder; Sinusitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Disabling	Influenza
0119754	03/05/1999	MN	29.0	28		F	03/02/1999	allergic rxn, eyes burned & watered, tongue & gums burned had asthma attack;ER gave pt pred & DPH & sent home;				Y					Y	10/22/1998	10/22/1998	0		PUB	PVT	Provental inhaler	NONE	asthma, allergic to cats & corn dust	NONE~ ()~~~In patient		1						1	Asthma; Condition aggravated; Eye pain; Gingival hyperplasia; Hypersensitivity; Lacrimal disorder; Tongue disorder	FLU3~CONNAUGHT LABORATORIES~0984590~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119767	03/05/1999	CA	85.0	85		M	11/17/1998	c/o severe diarrhea & vomiting;									U	11/16/1998	11/17/1998	1		PUB	PUB				~ ()~~~In patient	CA980150	1						1	Diarrhoea; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E20128GB~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0119772	03/08/1999	NC	63.0	63		F	03/02/1999	pt recv vax 6NOV98 & 21NOV98 exp numbness & tingling of feet, hands, & nose;severe pain of the muscular system by 23NOV98 & dx GBS; Per follow-up dated 10/4/00, the pt continues to experience fatigue, muscle pain particularly in the back, neuropathy of the feet, and insomnia.					Y	13			N	11/06/1998	11/21/1998	15	spinal fluid protein of 256mg percent	PVT	PVT	NA	NONE	atopic reactor			1						1	Asthenia; CSF test abnormal; Guillain-Barre syndrome; Insomnia; Myalgia; Neuropathy; Neuropathy peripheral; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0967090~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0119777	03/08/1999	NM	1.3	1	.3	F	12/01/1998	child fussy on 24NOV98 p/vax given & then had fever 25NOV98 brief sz;pt got blood cult & urine cult;pt was wheezing so given med;sent home but came back w/another sz & adm 25NOV98 until 26NOV98;came back later w/fever-looked good sent home				Y	Y	1			Y	11/24/1998	11/25/1998	1	all blood cult & urine cult x 2 negative no growth;	PUB	PUB	albuterol;Nitrofurantoin	mild viral synd (URI)	poor growth, vesicoureterel reflux, VSD, gastroesophageal reflux, developmental delay	unk~ ()~~~In patient	NM98027	1						1	Agitation; Asthma; Convulsion; Febrile convulsion; Pyrexia	DTAP~SMITHKLINE BEECHAM~862A2~4~IM~RL~DTAP (INFANRIX)~1|FLU3~MEDEVA PHARMA, LTD.~E20098GA~UNK~~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARCEL~MERCK & CO. INC.~0672H~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0119780	03/08/1999	MS	44.0	44		F	02/25/1999	Pt recv vax on 10/28/98; on 10/30/98 pt exp red/ heat/ pain of vax site-LA, watery eyes, rhinitis, myalgias, arthralgias; tx=Motrin, Claritin PO; dx=local allergic rxn to vax/ viral syndrome				Y					U	10/28/1998	10/30/1998	2	10/30/98: BP 127/75, Temp 98.8, P 85, R 20	OTH	OTH			Allergic to Codeine & Iodine	~ ()~~~In patient		1						1	Arthralgia; Hypersensitivity; Hypertension; Infection; Injection site hypersensitivity; Injection site pain; Lacrimal disorder; Myalgia; Pyrexia; Rhinitis; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0120140	03/09/1999	MA	44.0	44		M	03/03/1999	Pt recv vax on 2/17/99; 30 min post vax pt exp right face droop									N	02/17/1999	02/17/1999	0	Blood sugar 376	OTH	OTH			Pt allergic to Haldol & Lithium; Diabetic	~ ()~~~In patient		1						1	Facial palsy; Hyperglycaemia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0120142	03/10/1999	MA	52.0	52		M	03/03/1999	pt recv vax 20OCT98 & 3MAR99 reported: c/o back pain 6NOV--7NOV w/increasing intensity on 8NOV;c/o chest pain;adm to hosp 9NOV98 w/dx of pericarditis;states MD feels there was a direct correlation between the flu vax & pericarditis;Annual follow-up received on 12/21/00 provides no additional data.					Y				N	10/20/1998	11/06/1998	17		PUB	PUB	NONE	NONE	hay fever		MA9904	1						1	Back pain; Chest pain; Collagen disorder; Pericarditis	FLU3~CONNAUGHT LABORATORIES~975790~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0119019	03/11/1999	OK	23.0	23		F	11/03/1998	Pt recv vax on 10/28/98; on 10/29/98 pt exp febrile rxn, cellulitis in rt arm w/ pain, fever (102F) x 3 days; tx=Cephalexin, Tylenol				Y					Y	10/28/1998	10/29/1998	1	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	OK996	1						2	Cellulitis; Pain; Pyrexia; Vasodilatation; Cellulitis; Infection; Injection site hypersensitivity; Injection site pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~4988204~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1510E~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~0939440~5~IM~LA~TD ADSORBED (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~4988249~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~1510E~1~IM~RA~PNEUMO (PNEUMOVAX)~2|TD~CONNAUGHT LABORATORIES~0939440~5~IM~LA~TD ADSORBED (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0117640	03/15/1999	TX	63.0	63		F	11/20/1998	pt recv vax 12NOV98 & 20NOV98 states arm where had vax was red, itching also could feel knot;pt to come to clinic for check, lt deltoid area w/ 9cm x 10cm red area w/o tenderness on palpation;area warm to touch;denies pain;									Y	11/12/1998	11/20/1998	8	NA	PUB	PUB		NONE	NONE	NA~ ()~~~In patient	TX98188	1						2	Injection site hypersensitivity; Injection site mass; Pruritus	FLU3~CONNAUGHT LABORATORIES~0975800~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|TD~CONNAUGHT LABORATORIES~0944780~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~2	USA		Influenza
0120260	03/15/1999	SD	64.0	64		F	10/16/1997	6:30 pm sudden onset of SOB, rapid shallow breathing followed by bronchial burning w/in 5min;7:30 called MD;7:45 to ER & had resp tx & DPH & s/sx resolved;Tired next day;				Y					Y	10/15/1997	10/15/1997	0		PUB	PUB	monthly Premarin;cycrin per order	NONE	on meds for menopause	NA~ ()~~~In patient	SD99012	1						1	Asthenia; Chest pain; Dyspnoea; Hyperventilation; Hypoventilation	FLU3~CONNAUGHT LABORATORIES~7F81803~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0120266	03/15/1999	MI	41.0	41		M		pt recv vax & w/in 20min pt became dizzy, SOB, felt feverish & flushed;pt exp chest pain, pulse 84 & uncomfortable;to hosp c/o chest pain, dizziness, SOB, n/v;given 02;diaphoresis				Y						11/30/1998	11/30/1998	0		PUB	PUB			Mitral Valve prolapse (grade 2);allerg to codeine, sulfa, iodine;	~ ()~~~In patient	MI99027	1						1	Cardiovascular disorder; Chest pain; Dizziness; Dyspnoea; Hyperhidrosis; Infection; Malaise; Pain; Pyrexia; Rash; Vasodilatation; Vomiting	FLU3~PFIZER\WYETH~4988228~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0120273	03/15/1999	SD	21.0	21		M	10/27/1998	7-8hr post vax pt c/o splitting h/a, fever 102,chills & vomiting; 27OCT98 marked improvement w/in 24hr post vax;				Y					Y	10/26/1998	10/26/1998	0		PUB	PUB	NONE	NONE	wolff-Parkinson-whitt synd	~ ()~~~In patient	SD99027	1						1	Headache; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~0968380~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0120282	03/15/1999	CA	62.0	62		F	02/05/1999	Pt recv vax on 10/15/98; on 10/15/98 pt exp aching; on 10/17/98 pt exp swelling of legs & ankles, joint & back pain, Achilles tendon pain, difficulty walking, erythema nodosum on shins &ventral aspect wrists				Y					U	10/15/1998	10/15/1998	0	Cocci IgM/IgG-neg, ANA-neg, ESR-56, CBC-11.1, Rheum factor-neg, Liver panel-neg	PVT	OTH	Levothyroid, PPD-negative	NONE	Hypothyroid	~ ()~~~In patient		1						1	Anaemia; Arthralgia; Erythema nodosum; Leukocytosis; Myalgia; Oedema peripheral; Tendon disorder	FLU3~PFIZER\WYETH~978846~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0120303	03/15/1999	TX	5.0	5		M	02/26/1999	Pt recv vax on 2/23/99; on 2/25/99 pt exp fever (103), diarrhea, rash of white bumps/red circles w/ itching, leg & arm pain; tx=antibiotic changed to Augmentin				Y					N	02/23/1999	02/25/1999	2	NONE	PUB	PUB	Cephalexin since 2/16/99; Pt recv HepB,MSD,0439H #2 &Flu,Connaught,0975800,#1 on 12/31/98	Respiratory infection	Asthma & other allergies	~ ()~~~In patient	99TX025	1						1	Diarrhoea; Pruritus; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~0975800~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SMITHKLINE BEECHAM~2811A2~3~~LA~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0120307	03/15/1999	SD	5.0	5		M	11/23/1998	Pt recv vax on 11/20/98; 2 hr post vax pt exp fine/ red rash over body, 8 hr post vax site puffy & red; tx=oatmeal bath										11/20/1998	11/20/1998	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	SD99028	1						1	Injection site hypersensitivity; Injection site oedema; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~0968380~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0120318	03/15/1999	SD	25.0	25		M		numbness in rt hand starting 2.5hr p/vax cont for 3 days & hasn't had any other problems;									Y	10/29/1997	11/29/1997	31	NONE	OTH	PUB	NONE	NONE	NONE	~ ()~~~In patient	SD99015	1						1	Paraesthesia	FLU3~CONNAUGHT LABORATORIES~7F81894~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0120319	03/15/1999	SD	37.0	37		F	10/30/1997	swelling in lt hand approx 5min p/vax sl numbness in fingertips @ that time;swelling more pronounced p/15min;no pitting;10:45 edema in hand et arm remains-no other sx;									Y	10/30/1997	10/30/1997	0	NONE	PUB	UNK		NONE	NONE	pt exp hand edema @ age 27 w/dentist (dry up mainly)~ ()~~~In patient	SD99014	1						1	Oedema peripheral; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~7F81803~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0120320	03/15/1999	SD				M	10/27/1997	3:20 c/o sore throat, tightness cough, tight;took Ibuprofen & felt better;27OCT97 states has been treated by chiropractor for past week for stiff neck muscles;chiropractor concerned may be r/t a virus;									Y	10/15/1997	10/15/1997	0		PUB	PUB	NONE	NONE	prev & ongoing treatment for pinched nerve in neck	NA~ ()~~~In patient	SD99013	1						1	Chest pain; Cough; Infection; Laryngospasm; Nuchal rigidity; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~7F81803~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0120398	03/15/1999	MN	40.0	40		F		Pt recv vax in 1999; post vax pt exp nausea										01/01/1999	01/01/1999	0		UNK	UNK				Pt recv Flu vax'97,exp dizzy,nausea,stiff neck,tingling,shakey/hot,sawwhitespots~ ()~~~In patient		1						1	Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0120366	03/16/1999	TX	38.0	38		F	03/11/1999	Pt recv vax on 10/30/98; on 10/31/98 pt exp sore vax site,{ weak, myalgia} entire body x 3 mon; tx=Alleve				Y					Y	10/30/1998	10/31/1998	1	M.R.I.-neg, Blood tests-neg, Parcentesis generalized	PVT	PVT	NONE	End of a cold	NONE	~ ()~~~In patient		1						1	Injection site pain; Myalgia; Myasthenic syndrome	FLU3~PARKDALE PHARMACEUTICALS~02298P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0120371	03/16/1999	KS	70.0	70		M	03/04/1999	Pt recv vax on 10/10/93; on 10/20/93 pt exp Guillain-Barre syndrome w/ paresthesia of L1 & L5, nerve root pain x 6 wk									Y	10/10/1993	10/20/1993	10	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Guillain-Barre syndrome; Pain; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0120372	03/16/1999	MD	61.0	61		F	03/01/1999	Pt recv vax on 11/10/98; on 11/11/98 pt exp ill feeling, pain in neck & back, dizzy, fever (102)x 4 days, unable to bend or turn neck									Y	11/10/1998	11/11/1998	1		PVT	OTH		NONE	NONE	~ ()~~~In patient		1						1	Back pain; Dizziness; Hypokinesia; Insomnia; Malaise; Neck pain; Nuchal rigidity; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E20188HE~UNK~IM A~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~451951~UNK~IM A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0120394	03/17/1999	PA	60.0			F	03/16/1999	lit ref;pt recv vax & devel marked fatigue, n, fever, diarrhea, oliguria & ecchymosis in lower extremities;dx thrombotic thrombocytopenic purpura (TTP);acute renal failure, microangiopathic hemolytic anemia,neuropsychiatric signs					Y				Y	10/01/1998	10/05/1998	4	platelet count 96,000, BUN 72, creatinine 6.2,  HCT 28.4, LDH 5,787, +ANA, renal bx:  necrosis of cortex, capillary loops, basement membrane w/ thrombi	OTH	OTH			hx of Reynaud's phenomenon; several +ANA w/o clinical autoimmune disease;	~ ()~~~In patient	MPU199900101	1						1	Antinuclear antibody; Asthenia; Blood creatinine increased; Blood lactate dehydrogenase increased; Blood urea increased; Condition aggravated; Diarrhoea; Ecchymosis; Haemolytic anaemia; Hypokinesia; Nausea; Oliguria; Paraesthesia; Pyrexia; Renal cortical necrosis; Renal failure acute; Thinking abnormal; Thrombocytopenia; Thrombocytopenic purpura	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0120395	03/17/1999	NH	50.0	50		F	03/15/1999	pt exp a progression of s/sx dx as GBS;pt hosp twice locally a/being sent to another hosp where placed on life support;pt remained on life support until shortly a/Christmas;p/being weaned from ventilator went to rehab for speech, OT & PT					Y	78			N	10/02/1998	10/04/1998	2	NONE	OTH	OTH	NONE		allergy-morphine		MPI199900100	1						1	Buccoglossal syndrome; Guillain-Barre syndrome; Hypokinesia; Hypoxia	FLU3~MEDEVA PHARMA, LTD.~E20228KA~2~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0120432	03/18/1999	NC	47.0	47		F	03/09/1999	w/in 45min of vax pt started getting red splotches on face;they were like hives;burning & itching;w/in 1 1/2hr whole face & neck was involved;took DPH & applied ATB ointment;									Y	03/05/1999	03/05/1999	0		PUB	PVT						1						1	Pruritus; Urticaria; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0120545	03/23/1999	CA	65.0	65		M	02/26/1999	Pt recv vax on 11/18/98; on same day pt exp muscle aches, cough, congestion, fever x 2 mon									Y	11/18/1998	11/18/1998	0	NONE	PUB	PUB			Diabetes, HTN, Gall stones	~ ()~~~In patient	CA980151	1						1	Cough; Myalgia; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~0984580~3~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0120549	03/23/1999	NV	35.0			F	10/17/1997	Pt recv vax on 10/8/97; on 10/9/97 pt exp erythema on arm w/ warmth x 1 wk									Y	10/08/1997	10/09/1997	1		OTH	OTH	NONE		NONE	~ ()~~~In patient		1						1	Rash; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0120564	03/24/1999	TX	58.0	58		M	03/17/1999	Pt recv vax on 10/20/98; 2 wk post vax pt exp flu, bronchitis				Y					N	10/20/1998	11/03/1998	14		PUB	PVT	TB skin test, Tuborsil, 247011,LA			~ ()~~~In patient		1						1	Bronchitis; Influenza	FLU3~PARKDALE PHARMACEUTICALS~02198P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0120569	03/24/1999	NY	75.0	75		M	01/27/1999	Pt recv vax on 10/29/98; immediately post vax pt exp vax site swelling/ tender/ warmth/ ecchymotic, clammy, no radial pulse, unresponsive, incontinent of urine, ashen color; tx=oxygen; dx=vasovagal syncope				Y					Y	10/29/1998	10/29/1998	0		PUB	PVT	Norvasc, ASA, Lorazepam		Pt allergic to Penicillin shots (pt can take tablets)	~ ()~~~In patient		1						1	Bradycardia; Ecchymosis; Hyperhidrosis; Injection site oedema; Injection site pain; Stupor; Syncope; Urinary incontinence; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0968410~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0120571	03/24/1999	CA	33.0	33		U		null report										10/23/1998	10/23/1998	0		UNK	UNK						1						1	Arthralgia	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0120721	03/29/1999	PA	69.0	68		F	01/18/1999	Pt recv vax on 10/12/98; on 10/13/98 pt exp warm/ itchy/ rash at vax site then to upper arm									Y	10/12/1998	10/13/1998	1		PVT	PVT	Fioricet, Premarin, Meprobamate, Miacalcin nasal spray	Hand injury 8/98		~ ()~~~In patient	U199800674	1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~CONNAUGHT LABORATORIES~0970520~UNK~A~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0120773	03/30/1999	OR	24.0	24		M	01/26/1999	redness, tenderness rt upper arm toward front dx allerg rxn to vaccine vs cellulitis secondary to IVDU (last 19JAN);				Y					U	01/20/1999	01/20/1999	0		OTH	PUB	PPD per TB clinic;	NONE	NKA, heroin use	unk~ ()~~~In patient	OR9903	1						1	Cellulitis; Hypersensitivity; Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4988200~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~455936~1~~RA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~0944780~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0120832	03/31/1999	WA	9.0	9		F	03/02/1999	Pt recv vax on 12/22/98; on 12/27/98 pt exp muscular weakness, loss of muscle tone & mass, fatigue									Y	12/22/1998	12/27/1998	5	Pt seen by pediatric neurology	PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Hypotonia; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~4988226~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0120864	04/02/1999	NC	42.0	42		F	12/01/1998	Pt recv vax on 10/21/98; on 10/24/98 pt exp swollen lymph glands, swollen glands across clavicles w/ neck & thyroid discomfort, lump in throat; tx=Ibuprofen				Y					Y	10/21/1998	10/24/1998	3		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Laryngospasm; Lymphadenopathy; Neck pain	FLU3~CONNAUGHT LABORATORIES~0980570~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0120903	04/05/1999	MN	34.0	34		F	03/30/1999	w/in 20min p/vax pt began to exp itching, hives & swelling to inj site;applied ice pack & took DPH;scalp & arms began to itch;seen in ER given epi & 02;				Y					N	10/15/1998	10/15/1998	0		MIL	OTH	Zoloft	NONE	possible latex allergy, seasonal allergies, depression	NONE~ ()~~~In patient		1						1	Hypoxia; Injection site oedema; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~0984590~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0120912	04/05/1999	WI	65.0	65		F	10/20/1998	approx 3hr p/vax pt devel fever 102.8,malaise,myalgia, bloodshot eyes, tightness in throat;				Y					Y	10/08/1998	10/08/1998	0	DPH;CBC, mini pnael, UA, CXR	PUB	PUB	ASA takes 6/day;had taken two this AM	NONE	arthritis	NA~ ()~~~In patient	WI98052	1						1	Conjunctivitis; Laryngospasm; Malaise; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0975850~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454956~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0120922	04/05/1999	WI	53.0	52		F	10/14/1998	pt recv vax 9OCT98 & arm was already red & bruised;pt was seen by RN on 12OCT98;site was red & extremely tender to touch;red area was approx 3in in diameter, center of red area bruised approx size of vax area was warm to touch;seen by MD				Y					Y	10/09/1998	10/09/1998	0		PUB	UNK		NONE		~ ()~~~In patient	WI98075	1						1	Ecchymosis; Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975810~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0120923	04/05/1999	WI	34.0	34		F	10/19/1998	lt arm swelling, redness @ site of inj & entire upper noted on 16OCT98 per pt;fever 102 48hr, weakness, malaise noted on 16OCT98 12noon per pt;advised to take Ibuprofen				Y					Y	10/15/1998	10/16/1998	1		PUB	PVT		NONE		~ ()~~~In patient	WI98072	1						1	Asthenia; Injection site hypersensitivity; Injection site oedema; Malaise; Pyrexia	FLU3~PFIZER\WYETH~4988204~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~MERCK & CO. INC.~1605E~1~IM~RA~HEP B (RECOMBIVAX HB)~1|PPV~PFIZER\WYETH~448174~1~SC~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0120936	04/05/1999	NC	51.0	50		F	01/07/1999	Pt recv vax on 11/2/98; on 11/5/99 pt exp knot/ red/ sore vax site w/ movement pain										11/02/1998	11/05/1998	3	NONE	PUB	PVT	Prilosec	NONE	Sinus problems	NONE~ ()~~~In patient	NC99004	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~MEDEVA PHARMA, LTD.~E20158HD~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0120961	04/05/1999	WI	53.0	53		F	10/30/1998	fever 1hr p/vax severe rt hip, leg pain & bilat rib pain 24OCT;fever lasted only 21OCT;hip & leg pain cont;saw chiropractor 24OCT;also had gen achiness;									Y	10/21/1998	10/24/1998	3		OTH	UNK	NONE		pt mom is highly allergic to meds & became very sick 1st coupl of times that recv flu vax mom cont to recv flu vax;	~ ()~~~In patient	WI98054	1						1	Arthralgia; Myalgia; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E20208HB~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0120970	04/05/1999	WI	73.0	73		F	11/02/1998	28OCT98 lt arm w/lump, redness, itching since 22OCT98 now has diffuse redness 8cm width 4cm height, warm to touch;advised compress;2NOV98 presents w/sl redness lt arm w/firm area approx 1/2;relief noted w/ice pack;									Y	10/22/1998	10/22/1998	0		PUB	PUB	Calan;synthroid;		allergic to IVP dye;	~ ()~~~In patient	WI98071	1						1	Injection site hypersensitivity; Injection site mass; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4988204~7+~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~0934600~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0120986	04/06/1999	CA	57.0	57		F	04/02/1999	delayed redness w/dime size swelling x 3mo;									U	12/04/1998				PVT	PVT				~ ()~~~In patient		1						1	Oedema; Vasodilatation	FLU3~PFIZER\WYETH~4988202~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0119433	04/08/1999	WA	35.0	35		M		arms was swollen from shoulder to elbow, hard, painful, fever 99-100;pt reported the reaction was to the flu vax;				Y					Y	10/20/1998				OTH	PVT				NONE~ ()~~~In patient	WA991539	1						2	Oedema peripheral; Pain; Pyrexia; Skin nodule; Injection site mass; Injection site oedema; Injection site pain; Pyrexia	FLU3~PFIZER\WYETH~4988200~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~454383~1~IM~~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~4988200~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~454383~1~IM~~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0121022	04/08/1999	MD	58.0			M	03/31/1999	pt recv vax & w/in 5 days pt devel arthritic pain in hands, hips & knees;consulted MD;Ibuprofen prescribed which provided only mild relief;treating MD to r/o Lupus;pt states arthritis sx worsening, having difficulty walking & writing									N	10/01/1998			lyme test negative; ANA positive;	OTH	OTH			asthma;hay fever;	~ ()~~~In patient	MPI982053	1						1	Antinuclear antibody; Arthritis; Hypokinesia; Systemic lupus erythematosus	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0121024	04/08/1999	WA	14.0	14		M		pt recv vax 15OCT98 & 30hr later pt became tired, had h//a lasted through weekend;Monday got throbbing h/a w/disorientation while playing football;insomnia;lethargy & mood disturbance, depressed;poss sinus infect;inability to concentrate;				Y					N	10/15/1998	10/16/1998	1	25NOV98 IGG Epstein Barr Antibody elevated 1.56;kidney, liver, lytes all WNL;CBC came back showing no s/s anemia or infect;cholesterol 165, LDL 67 & HDL 62;mono test negative;22JAn99 alk phos 262;chloride 111;anion gap 3.2;bun/creat 26.3;	PUB	PUB	NONE	NONE	poss rxn to HIB in 1986	pt had dec RBC count w/HIB in 1986 #2;~ ()~~~In patient	WA991537	1						1	Affect lability; Arthralgia; Asthenia; Blood alkaline phosphatase increased; Blood urea increased; Bone disorder; Confusional state; Globulins increased; Headache; Hyperchloraemia; Infection; Influenza; Insomnia; Laboratory test abnormal; Lymphadenopathy; Pharyngitis; Sinusitis; Somnolence; Thinking abnormal	FLU3~CONNAUGHT LABORATORIES~0968380~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0121033	04/08/1999	WA	75.0	75		M	02/09/1999	aching & pain in back & hips bilat;also lt shoulder pain, some rt shoulder pain;hx back & shoulder pain, hx of stress;one episode of lower abd pain & diarrhea;									U	10/13/1998	10/18/1998	5	CBC, SR, SPE, rheumatoid factor, ANA comprehensive;	PVT	PVT	pepcid AC occ advil	aching & pain back & hips also lt shoulder;	stress, back & shoulder pain, HTN, heartburn	NONE~ ()~~~In patient	WA991536	1						1	Anaemia; Antinuclear antibody; Arrhythmia; Back pain; Condition aggravated; Coordination abnormal; Depression; Diarrhoea; Dyspnoea; Hypokinesia; Hyporeflexia; Influenza; Laboratory test abnormal; Myalgia; Myasthenic syndrome; Neuralgia; Neuropathy; Pain; Paralysis; Pelvic pain; Red blood cell sedimentation rate increased	FLU3~PARKDALE PHARMACEUTICALS~4988202~7+~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0116952	04/12/1999	CO	78.0	77		M	11/24/1998	pt recv vax 19OCT98 & 28OCT98 pt came down w/the flu;pt achy, chilly, sweaty, variety;no vomiting or queasiness but the stomach did indicate that it wasn't too interested in seeing food coming its way;lots of water followed by sweating;									Y	10/19/1998	10/28/1998	9		UNK	UNK		NONE		pt devel flu p/flu vax;~ ()~~~In patient		1						2	Anorexia; Chills; Hyperhidrosis; Influenza; Myalgia; Thirst	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0121107	04/12/1999	MI	5.0	4		M	03/25/1999	pt recv vax 4NOV98 & 5NOV98 mom noticed some redness of rt arm near inj site;later that day father noticed swelling & redness;pt seen @ urgent care & dx w/cellulitis;started on ATB for 7-10 day course-pt fine according to mom 3 days later;				Y					Y	11/04/1998	11/05/1998	1		PUB	PUB		NONE	asthma;allergic to milk & cats;	~ ()~~~In patient	MI99035	1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4988204~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0121167	04/13/1999	KY	53.0	53		M	04/08/1999	pt got sick on 8MAY97 w/flu like sx;on 12MAY97 put in ICU for 6wk then sent to hosp for 11months;pt was paralyzed & on a respirator & blood infect & pneumonia & up in a wheel chair & a walker;GBS					Y	365		Y	Y	07/01/1996	05/08/1997	311		PUB	UNK	NONE		liver problems; sickle cell trait	~ ()~~~In patient		1						1	Dysphagia; Eyelid ptosis; Guillain-Barre syndrome; Hypokinesia; Hypoxia; Influenza; Paralysis; Pneumonia; Respiratory disorder; Sepsis	FLU3~CONNAUGHT LABORATORIES~6F71288~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0116608	04/15/1999	OK	57.0			M	04/09/1999	pt recv vax & 8 days p/vax underwent a CBC & was found to have a platelet count of zero;pt adm to hosp;  Annual follow-up received on 10/02/00 provided no additional data.			Y		Y				U	10/13/1998	10/21/1998	8	NONE	OTH	OTH			NONE		MPI199900123A	1						2	Thrombocytopenia	FLU3~MEDEVA PHARMA, LTD.~E20088BFC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Life Threatening,Hospitalisation	Influenza
0116803	04/15/1999	OK	64.0			M	04/09/1999	pt recv vax & underwent a CBC & was found to have a platelet count of zero;pt was adm to hosp;  Annual follow-up received 10/2/00 provided no additional text.			Y		Y				U	10/27/1998	11/05/1998	9	NONE	OTH	OTH			NONE		MPI199900123B	1						2	Thrombocytopenia	FLU3~MEDEVA PHARMA, LTD.~E2008BFC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~PFIZER\WYETH~454967~UNK~IM~~PNEUMO (PNU-IMUNE)~2	USA	Life Threatening,Hospitalisation	Influenza
0121234	04/15/1999	IL	51.0	51		F	04/01/1999	p/vax pt did not feel well, had waves of nausea until 2DEC lt eye weak;had difficulty w/drinking, h/a;5DEC Bell's palsy dx, tx w/pred;  as of 1APR cont w/altered taste & lt eye vague weakness;								Y	N	10/16/1998	12/02/1998	47	CBC;Chem screen;	OTH	PVT	NONE	NONE	sulfa allergy	NONE~ ()~~~In patient		1						1	Dysgeusia; Dysphagia; Eye disorder; Facial palsy; Headache; Malaise; Nausea	FLU3~CONNAUGHT LABORATORIES~0972870~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0121351	04/20/1999	TX	43.0	43		F	03/25/1999	pt recv vax 14OCT98 & reports malaise onset w/in hr;next day reports pain & swelling of lt arm;has had a hx of malaise, joint pain & swelling & rheumatoid like complaints p/a full work up MD concluded flu vax caused syndrome;									N	10/14/1998	10/14/1998	0	negative cat scratch fever, negative epstein barr virus, negative lupus, negative rhematoid arthritis, negative dengenerative disc disease;	OTH	PUB	Triphasil;Celebrex, Zoloft, Ambian, Synthroid	NONE	hypothyroid	pt exp flu sx @ age 3 w/flu vax;~ ()~~~In patient		1						1	Malaise; Oedema peripheral; Pain; Rheumatoid arthritis	FLU3~CONNAUGHT LABORATORIES~0984540~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121480	04/26/1999	CA	4.0	4		M	03/11/1999	swelling and redness at injection site;										12/12/1998	12/13/1998	1		PVT	OTH		cough w/wheezing;bronchitis;		~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PARKDALE PHARMACEUTICALS~02098P1~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1339H~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0121644	04/26/1999	TX	36.0	36		U		flu-like illness;									Y	11/01/1998	02/16/1999	107		OTH	PUB				~ ()~~~In patient	TX99077	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0973930~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121585	04/27/1999	TX	37.0	37		U		flu-like illness 8FEB99 w/cough, nasal congestion & inc temp;treated w/pseudoephedrine & APAP;					Y				Y	10/28/1998	02/08/1999	103	viral cult positive flu A	OTH	PUB			seizure disorder,scoliosis,mental retardation,cerebral palsy,visual impairment,microcephaly,allergic rhinitis	~ ()~~~In patient	TX99068	1						1	Anaemia; Anorexia; Asthma; Blood alkaline phosphatase increased; Condition aggravated; Convulsion; Cough; Drug ineffective; Hypertension; Hypoproteinaemia; Hypoxia; Infection; Influenza; Laboratory test abnormal; Leukocytosis; Pyrexia; Rhinitis; Tachycardia	FLU3~CONNAUGHT LABORATORIES~0973930~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0121603	04/27/1999	MN	47.0	47		F	04/21/1999	Pt recv vax on 11/4/98; 3 1/2 hr post vax pt exp fever, chills, neck ache, chest & arm pain									Y	11/04/1998	11/04/1998	0		OTH	PVT				~ ()~~~In patient		1						1	Chest pain; Myalgia; Neck pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0988300~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121620	04/27/1999	TX	44.0	44		U		16FEB99 T99.4R, nasal drainage, emesis sudafed & fluids;17FEB99 T102.4, couth-Robitussin, APAP;22FEB99 afeb x 24hr;flu dx;									Y	10/19/1998	02/16/1999	120		UNK	UNK				~ ()~~~In patient	TX99051	1						1	Cough; Influenza; Pyrexia; Rhinitis; Vomiting	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121621	04/27/1999	TX	38.0	38		U		17FEB99 productive cough, nasal drainage, inc temp sudafed, APAP, augmentin;flu dx;									Y	10/19/1998	02/17/1999	121		UNK	UNK				~ ()~~~In patient	TX99053	1						1	Cough; Influenza; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121622	04/27/1999	TX	41.0	41		U		16FEB99 clear nasal drainage, temp, sudafed, APAP, fluids;flu dx;									Y	10/19/1998	02/16/1999	120	viral cult negative;	UNK	UNK				~ ()~~~In patient	TX99054	1						1	Influenza; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121623	04/27/1999	TX	45.0	44		U		12FEB99 inc temp, nasal drainage, sore throat, sudafed, APAP, fluids;flu dx;									Y	10/19/1998	02/12/1999	116		UNK	UNK				~ ()~~~In patient	TX99055	1						1	Influenza; Pharyngitis; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121624	04/27/1999	TX	56.0	56		U		8FEB99 inc temp APAP;Bactrim;flu dx;									Y	10/19/1998	02/08/1999	112		UNK	UNK				~ ()~~~In patient	TX99056	1						1	Influenza; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121625	04/27/1999	TX	44.0	44		U		14FEB99 inc temp, cloudy nasal drainage APAP,sudafed, amoxicillin; flu dx;									Y	10/19/1998	02/14/1999	118		UNK	UNK	PPD by Parke Davis lot# 02598P given 2FEB99			~ ()~~~In patient	TX99057	1						1	Influenza; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121626	04/27/1999	TX	44.0	44		U		21FEB99 inc temp, congestion, cough, APAP;flu dx;									Y	10/19/1998	02/21/1999	125		UNK	UNK				~ ()~~~In patient	TX99058	1						1	Cough; Influenza; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121627	04/27/1999	TX	45.0	45		U		14FEB99 inc temp, nasal drainage, cough, Robitussin DM, sudafed, APAP;flu dx;									Y	10/19/1998	02/14/1999	118		UNK	UNK				~ ()~~~In patient	TX99059	1						1	Cough; Influenza; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121628	04/27/1999	TX	37.0	37		U		13FEB99cough, fever, Robitussin DM, APAP;flu dx;									Y	10/22/1998	02/13/1999	114		UNK	UNK				~ ()~~~In patient	TX99060	1						1	Cough; Influenza; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121629	04/27/1999	TX	43.0	43		U		10FEB99 inc temp, emesis;flu dx;									Y	10/22/1998	02/10/1999	111		UNK	UNK				~ ()~~~In patient	TX99061	1						1	Influenza; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121630	04/27/1999	TX	57.0	56		U		inc temp, nasal drainage, cough, APAP, sudafed, fluids, flu dx;									Y	10/22/1998	02/10/1999	111		UNK	UNK				~ ()~~~In patient	TX99062	1						1	Cough; Influenza; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121631	04/27/1999	TX	43.0	43		U		8FEB99 inc temp, congestion, cough, APAP, 02, ATB, (bactrim),flu dx;									Y	10/22/1998	02/08/1999	109		UNK	UNK				~ ()~~~In patient	TX99063	1						1	Cough; Hypoxia; Influenza; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121632	04/27/1999	TX	39.0	39		U		13FEB99 nasal congestion, cough, inc temp, dimetapp, robitussin DM; flu dx;									Y	10/22/1998	02/13/1999	114		UNK	UNK				~ ()~~~In patient	TX99064	1						1	Cough; Influenza; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121633	04/27/1999	TX	38.0	38		U		21FEB99 inc fever, nasal drainage, cough-sudafed, APAP, flu dx;									Y	10/22/1998	02/21/1999	122		UNK	UNK				~ ()~~~In patient	TX99065	1						1	Cough; Influenza; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121634	04/27/1999	TX	38.0	38		F		12FEB99 influenza A per throat cult, cough, nasal drainage, inc temp;flu dx;									Y	10/22/1998	02/12/1999	113	viral cult positive flu A	UNK	UNK				~ ()~~~In patient	TX99066	1						1	Cough; Infection; Influenza; Laboratory test abnormal; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121635	04/27/1999	TX				F	03/17/1999	flu-like illness;									Y	10/20/1998	02/17/1999	120		UNK	UNK				~ ()~~~In patient	TX99067	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0973930~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121636	04/27/1999	TX	28.0	28		U		Pt recv vax on 10/22/98; on 2/17/99 pt exp flu-like illness of fever, nasal congestion, cough; tx=Sudafed, Tylenol									Y	10/22/1998	02/17/1999	118		OTH	PUB				~ ()~~~In patient	TX99069	1						1	Cough; Influenza; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0973930~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121637	04/27/1999	TX	46.0	46		F	03/17/1999	Pt recv vax on 10/20/98; on 2/15/99 pt exp flu-like illness									Y	10/20/1998	02/15/1999	118		OTH	OTH				~ ()~~~In patient	TX99070	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0973430~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121638	04/27/1999	TX	76.0	76		F	03/17/1999	Pt recv vax on 10/20/98; on 2/18/99 pt exp flu-like illness									Y	10/20/1998	02/18/1999	121		OTH	OTH				~ ()~~~In patient	TX99071	1						1	Influenza	FLU3~PFIZER\WYETH~4988332~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0121639	04/27/1999	TX				U		Pt recv vax on 10/21/98; on 2/16/99 pt exp flu-like illness									Y	10/21/1998	02/16/1999	118		OTH	PUB				~ ()~~~In patient	TX99072	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0973930~7+~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121640	04/27/1999	TX	49.0	49		U		flu-like illness;									Y	10/21/1998	02/16/1999	118	viral cult positive flu A	OTH	PUB				~ ()~~~In patient	TX99073	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0973930~7+~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121641	04/27/1999	TX	39.0	39		U		flu-like illness;									Y	10/25/1998	02/19/1999	117		OTH	PUB				~ ()~~~In patient	TX99074	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0973930~6~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121642	04/27/1999	TX	32.0	32		U		flu like sx;									Y	11/10/1998	02/24/1999	106		UNK	UNK				~ ()~~~In patient	TX99075	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121643	04/27/1999	TX	45.0	45		U		flu like illness									Y	10/21/1998	02/23/1999	125		OTH	PUB				~ ()~~~In patient	TX99076	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0973930~4~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121645	04/27/1999	TX	39.0	38		U		flu-like illness;									Y	10/22/1998	02/12/1999	113		OTH	PUB				~ ()~~~In patient	TX99078	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0973930~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121646	04/27/1999	TX	39.0	39		U		flu-like illness;									Y	10/22/1998	02/13/1999	114		OTH	PUB				~ ()~~~In patient	TX99079	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0973930~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121647	04/27/1999	TX	41.0	41		U		flu-like illness (viral throat cult attempted);									Y	10/21/1998	02/18/1999	120	(viral throat cult attempted)	OTH	PUB				~ ()~~~In patient	TX99080	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0973930~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121648	04/27/1999	TX	26.0	26		U		flu like sx;									Y	11/15/1998	02/23/1999	100		UNK	UNK				~ ()~~~In patient	TX99081	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121649	04/27/1999	TX	38.0	38		U		flu like sx;									Y	11/15/1998	02/23/1999	100		UNK	UNK				~ ()~~~In patient	TX99082	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121650	04/27/1999	TX	34.0	34		U		flu like sx;									Y	11/15/1998	02/24/1999	101		UNK	UNK				~ ()~~~In patient	TX99083	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121651	04/27/1999	TX	40.0	40		U		flu like sx;									Y	11/15/1998	02/24/1999	101		UNK	UNK				~ ()~~~In patient	TX99084	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121652	04/27/1999	TX	36.0	36		U		flu like sx;									Y	11/15/1998	01/20/1999	66		UNK	UNK				~ ()~~~In patient	TX99085	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121653	04/27/1999	TX	50.0	49		U		flu like sx;									N	11/15/1998	02/25/1999	102		UNK	UNK					TX99086	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121654	04/27/1999	TX	50.0	50		U		flu like sx;									Y	11/07/1998	02/25/1999	110		UNK	UNK				~ ()~~~In patient	TX99087	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121655	04/27/1999	TX	44.0	43		U		flu like sx									Y	11/07/1998	02/26/1999	111		UNK	UNK				~ ()~~~In patient	TX99088	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121656	04/27/1999	TX	28.0	28		U		flu like sx;									Y	11/07/1998	02/25/1999	110		UNK	UNK				~ ()~~~In patient	TX99089	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121657	04/27/1999	TX	43.0	43		U		flu like sx;									Y	11/10/1998	02/27/1999	109		UNK	UNK				~ ()~~~In patient	TX99090	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121658	04/27/1999	TX	38.0	38		U		flu like sx									Y	11/10/1998	02/20/1999	102		UNK	UNK				~ ()~~~In patient	TX99092	1						1	Influenza	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121659	04/27/1999	TX	38.0	38		U		16FEB99 influenza a per throat cult;cough, nasal congestion, sore throat;APAP, sudafed, augmentin;flu dx;									Y	10/19/1998	02/16/1999	120	viral cult-influenza A	UNK	UNK				~ ()~~~In patient	TX99093	1						1	Cough; Infection; Influenza; Laboratory test abnormal; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0121698	04/29/1999	MA	16.0	16		M	04/22/1999	devel malaise 18hr p/vax no fever, h/a, severe myalgias w/in 20hr of recv vax;these signs cont for 7 days, fever was 102-104, along w/rhinorrhea, lt earache causing pt to miss a week of school;				Y					Y	11/17/1998	11/18/1998	1	NA	PVT	PVT	Zyrtec;Icus multivit/mineral/day	NONE	allergies to molds, ragweed, trees, grasses (rhinitis) + asthma following some URI's	~ ()~~~In patient		1						1	Ear pain; Headache; Malaise; Myalgia; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~1094H~1~~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0121787	04/30/1999	OK	37.0	37		M	02/18/1999	Pt recv vax on 10/24/97;on 10/25/97 pt exp red/hot/painful vax site -rt armx1 wk;tx=Benadryl, Advil; in 1/98 pt exp rt ankle &heel pain, 2/98 shoulder &joint pain cont;dx=inflammation of fascia tendon, possible Perthes Disease or bacteria				Y					N	10/24/1997	10/25/1997	1	2/98 Blood test series &ANA- rheumatoid factors, ANA elevated; 1/99 Pt referred to rheumatologist, 1/99 Blood test series/rheumatoid factor-normal ANA-elevated	PUB	PUB	NONE	NONE	Allergic to Sulfa	NONE~ ()~~~In patient	OK9916	1						1	Antinuclear antibody; Arthralgia; Arthropathy; Bronchitis; Infection; Injection site hypersensitivity; Injection site pain; Laboratory test abnormal; Myalgia; Tendon disorder; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~E3277GA~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~0906E~1~IM~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0116714	05/06/1999	MD	49.0	49		F	01/08/1999	pt recv vax & 10hr later was awakened by h/a, cold sweats, dizziness, chills, diarrhea & pain @ the inj site;pt vomited until 7AM & felt weak, tired & disoriented;pt returned to work 10/28/98;									Y	10/26/1998	10/27/1998	1	NONE	PUB	PUB	NONE	NONE	hayfever	NONE~ ()~~~In patient	899012051A	1						2	Asthenia; Chills; Confusional state; Diarrhoea; Dizziness; Headache; Hyperhidrosis; Injection site pain; Vomiting	FLU3~PFIZER\WYETH~4988212~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0117071	05/06/1999	MD	77.0	77		F	01/08/1999	pt recv vax & felt blah & achy & had a runny nose;pt had a hx of atrial fibrillation;11/8/98 pt exp episode of atrial fibrillation & devel h/a;11/18/98 exp severe muscle aches all over;dx polymyalgia rheumatica;erythrocyte sed rate was 112;				Y					U	10/26/1998	10/26/1998	0	erythrocyte sedimentation rate 112 mm/hr;	PUB	PUB	coumadin;Hyzaar;Corgard;lasix;Pravachol;	NONE	atrial fibrillation;HTN	NONE~ ()~~~In patient	899012054A	1						2	Atrial fibrillation; Headache; Malaise; Myalgia; Red blood cell sedimentation rate increased; Rhinitis	FLU3~PFIZER\WYETH~4988212~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0121944	05/06/1999	NJ				M	11/11/1998	pt recv vax & devel swelling of a single axillary lymph node;									Y				unk	PVT	PVT	unk	unk		pt devel swelling of rt axillary & cervical lymph nodes, as well as an inj site~ ()~~~In patient	899011002L	1						1	Lymphadenopathy	FLU3~PFIZER\WYETH~~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0121945	05/06/1999	OK	48.0			F	11/04/1998	pt recv vax devel an inj site rxn characterized by a big wheal & knot;									Y					OTH	PVT	unk	NONE	obesity & numerous skin allergies;	pt devel a wheal & knot @ the inj site p/flu vax;~ ()~~~In patient	899011004L	1						1	Injection site mass; Urticaria	FLU3~PFIZER\WYETH~~1~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0121946	05/06/1999	WI	44.0			F	01/21/1999	pt recv vax & reporter stated did not know what type of rxn but thinks it was similar to anaphylactic rxn. Anaphylaxis. A nurse reported that a hospitalized 44-year-old female received an injection of flu shield (1998-99 Formula) and IV gamma globulin and subesquently experienced an adverse event. The reporter stated. I don't know what type of reaction but I think it was similar to anaphylactic reaction. No further information was available at the date of this report. Follow-up information received on 28-FEB-2001 from a healthcare professional indicated the patient has sinced recovered.			Y						Y				Unknown	OTH	OTH	Gamma Globulin IV	unknown	unknown		899022106A	1						1	Anaphylactoid reaction	FLU3~PFIZER\WYETH~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening	Influenza
0121947	05/06/1999	LA	54.0	54		F	12/10/1998	pt recv vax & devel polymyalgia rheumatica;									U	10/18/1998			unk	MIL	MIL	unk	unk	unk	unk~ ()~~~In patient	898345101A	1						1	Myalgia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0121950	05/06/1999	OH	76.0	76		M	01/13/1999	pt recv vax & exp pain in the periumbilical area & hard stool;CXR was performed & was nl;pt was referred to cardiologist;									U	12/11/1998			CXR nl;	OTH	OTH	unk	unk	unk	unk~ ()~~~In patient	899019001L	1						1	Constipation; Pain; Abdominal pain; Constipation	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~~~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~~UNK~~~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0121951	05/06/1999	UT	74.0			M	12/15/1998	pt recv vax & 1mo later devel a pruritic rash;tx w/daily hot showers;									U	10/13/1998	11/01/1998	19	unk	OTH	OTH	Tenormin;ASA;folic acid;	NONE	HTN, 2 episodes of kidney stones 15-16 years ago, quadruple coronary artery bypass grafting in 1987, elevated homocysteine levels;	pt devel a rash on chest & back p/flu vax;~ ()~~~In patient	899035004L	1						1	Pruritus; Rash	FLU3~PFIZER\WYETH~~3~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0121952	05/06/1999	TN				U	02/02/1999	pt recv vax late 1998 or early 1999 & devel influenza in 1/99;hlth dept told MD that an H3N2 strain was circulating in are;exact strain not provided;									Y		01/01/1999		unk	PVT	PVT	unk	NONE	unk	unk~ ()~~~In patient	899036098A	1						1	Infection	FLU3~PFIZER\WYETH~4988337~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0121953	05/06/1999	TN				M	02/02/1999	pt recv vax 1998 or early 1999 & 1/99 pt devel influenza;local hlth dept reported a H3N2 strain circulating in area;exact strain was not provided;									Y		01/01/1999		unk	PVT	PVT	unk	unk	unk	unk~ ()~~~In patient	899040085A	1						1	Infection	FLU3~PFIZER\WYETH~4988337~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0121954	05/06/1999	NY	67.0	67		F	01/29/1999	pt recv vax & devel a small area of redness @ one of the inj sites;the next day devel a 15 to 17cm area of warmth, swelling, pain & induration @ one of the sites & a fever of 102.2 w/shaking chills;									Y	01/28/1999	01/28/1999	0	NONE	PVT	PVT	Lopressor;Diovan;Zocor;Premarin;Ecotrin;Vitamins;	NONE	HTN, hyperlipidemia & allergic to ticlid & percocet;	unk~ ()~~~In patient	899048001L	1						1	Chills; Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Pyrexia; Tremor; Vasodilatation; Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Pyrexia; Tremor	FLU3~PFIZER\WYETH~4988234~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~454386~2~IM A~~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~4988234~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~454386~2~IM A~~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0121955	05/06/1999	MN				U	02/23/1999	several pt recv vax & 6-8wk later had false positive test results for infectious mononucleosis using test kits manufactured by reporter's company;									U				test for infectious mononucleosis: positive;	MIL	MIL	unk	unk	unk	unk~ ()~~~In patient	899057023A	1						1	Unevaluable event	FLU3~PFIZER\WYETH~4988240~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0121956	05/06/1999	IN	54.0	54		F	03/05/1999	pt recv vax & devel dermatitis characterized by burning, itching & transitory redness over both eyes;pt recently discovered allergic to thimerosal;pt attributed dermatitis to allergic rxn to thimerosal;									U	11/01/1998	11/01/1998	0	unk	PUB	OTH	NONE	NONE	allergic to thimerosal	unk~ ()~~~In patient	899068101A	1						1	Hypersensitivity; Pain; Pruritus; Rash; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0121957	05/06/1999	TN				F	02/02/1999	pt recv vax 1998 or early 1999 & 1/99 pt devel influenza;the local hlth dept told MD that an H3N2 strain was circulating in the area;exact strain was not provided;									Y		01/01/1999		unk	PVT	PVT	unk	unk	unk	unk~ ()~~~In patient	899116001L	1						1	Infection	FLU3~PFIZER\WYETH~4988337~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0122003	05/10/1999	SC	18.0	18		F	03/15/1999	pt became quickly dizzy p/vax;lt lower lobe wheezes noted called for epi & DPH pt began wheezing audibly w/SOB;stopped breathing, rescue breathing started, unable to ventilate became pulseless began CPR;breathing p/1min CPR, 02, IV;				Y					Y	03/15/1999	03/15/1999	0		MIL	MIL	PPD by Connaught lot# 248811 given 24FEB99	NONE	unk	~ ()~~~In patient		1						1	Apnoea; Asthma; Bradycardia; Dizziness; Dyspnoea; Hypoventilation; Hypoxia	FLU3~PFIZER\WYETH~4988247~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|MMR~MERCK & CO. INC.~1544H~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TD~LEDERLE LABORATORIES~451315~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0122006	05/10/1999	SC	20.0	20		F	03/15/1999	c/o feeling dizzy & SOB sat down, upper airway wheezes gave epi & transferred to trauma room;				Y					Y	03/15/1999	03/15/1999	0		MIL	MIL	PPD by Connaught lot# 248811 given 24FEB99	c/o recent cold	unk	~ ()~~~In patient		1						1	Asthma; Dizziness; Dyspnoea	FLU3~PFIZER\WYETH~4988247~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~LEDERLE LABORATORIES~451315~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0122098	05/11/1999	IL	63.0	63		M	03/17/1999	pt reported dry, hacky cough since 1OCT98 & still has the dry hacky cough;										10/01/1998	10/10/1998	9	unk	UNK	PVT	Diovan	NONE	HTN, Back Problem	~ ()~~~In patient	FLU98140399	1						1	Cough	FLU3~PARKDALE PHARMACEUTICALS~01998P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0122103	05/13/1999	PA	67.0			F	05/06/1999	Pt recv vax on 10/16/98; post vax pt exp discomfort, tingling, paresthesia, weak lt leg; pt cont difficulty grasping w/ lt hand				Y					U	10/16/1998				PVT	OTH	UNK	UNK	UNK	NONE~ ()~~~In patient	FLU101220599	1						1	Hypotonia; Movement disorder; Myasthenic syndrome; Pain; Paraesthesia; Neuropathy; Pain; Paraesthesia; Tremor; Arthralgia; Movement disorder; Neuritis; Pain; Paraesthesia	FLU3~PARKDALE PHARMACEUTICALS~0981810~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~2|FLU3~CONNAUGHT LABORATORIES~0981810~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~3	USA	Emergency room visit	Influenza
0122174	05/17/1999	ND	41.0	41		F	02/06/1999	pt recv vax 30OCT98 & felt extremely tired;devel sore throat, chills, felt like was coming down w/flu;sudden onset @ 7PM left for hosp;blotches of redness on face & throat @ hosp diff breathing,dyspnea;bronchospasm, throat & chest tightness			Y	Y	Y	8			Y	10/30/1998	10/30/1998	0		PUB	UNK	Valium	NONE	NONE	NONE~ ()~~~In patient		1						1	Asthenia; Asthma; Bronchiolitis; Bronchitis; Chest pain; Chills; Dyspnoea; Hypersensitivity; Hypoventilation; Influenza; Laryngeal oedema; Laryngospasm; Pharyngitis; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~0985890~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0124183	05/21/1999	KS	16.0	16		M	05/14/1999	7 days p/vax pt devel chickenpox that consisted of cluster & pustules that were scabbing over.									Y	10/09/1998	10/16/1998	7		PVT	PVT	insulin		diabetes mellitus; varicella exposure	no relevant data~ ()~~~In patient	WAES98110272	1						1	Dermatitis bullous; Infection	FLU3~PARKDALE PHARMACEUTICALS~~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|VARCEL~MERCK & CO. INC.~0808E~1~SC~~VARICELLA (VARIVAX)~1	USA		Influenza
0124184	05/21/1999	KS	14.0	13		M	05/14/1999	8 days p/ vax pt exp chickenpox				Y					Y	10/09/1998	10/17/1998	8		PUB	PUB			varicella exposure	no relevant data~ ()~~~In patient	WAES98110273	1						1	Infection	FLU3~PARKDALE PHARMACEUTICALS~~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|VARCEL~MERCK & CO. INC.~0808E~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0124219	05/21/1999	CA	22.0	22		F	05/14/1999	p/vax pt serum varicella zoster virus antibodies test revealed vaccine failure (0.73);									U	10/21/1998	11/05/1998	15	11/5/98 serum varicella zoster 0.73 negative varicella titers;	UNK	UNK			unk	No Relevant Data~ ()~~~In patient	WAES98111074	1						1	Drug ineffective	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~0495H~2~SC~~VARICELLA (VARIVAX)~1	USA		Influenza
0124241	05/21/1999	OH	5.0	5		M	05/14/1999	pt recv vax during 2 week break from steroid tx for hx reactive airway; restarted steroids 1 1/2 weeks a/ sx occurred; 18d p/ vax, presented w/ lesions; hosp w/ VZV pneumonia, decompensated, intubated-on vent; required 3 blood transfusion. This is an follow-up to report(s) previously submitted on 5/14/1999. Information has been received from a health care professional concerning a 5-year-old male patient who in 1998 was vaccinated with one dose of VARIVAX. Approximately ten days following vaccination, the patient experienced a rash (time frame unknown) and was eventually hospitalized with VZV pneumonia. At the time of the report, the patient was on a ventilator in the PICU. It was reported that in approximately 17-NOV-1998, DFA analysis of endotracheal secretions was done for CMV, HSV, flu A and B and RSV, all of which were negative; however, DFA for VZV was strongly positive. In addition, specimens were negative for sycoplasm IgM. Additional information received indicated that in approximately 17-NOV-1998, results of PCR analysis from an endotracheal specimen were positive for vaccine strain varicella zoster virus. It was also reported that the patient recovered and was discharged. The patient had a history of reactive airway disease and the physician believed the patient had been on a course of steroids 10 days prior to vaccination. The patient did have a rash on admission however, it was not severe. However, the patient did decompensate quickly from a respiratory perspective and required intubation with ventilator assist. The patient required ventilatory support for approximately 6 weeks. The physician did not know if the patient acquired a noseomial infection while on the ventilator which would have complicated the patient's course. Further additional information indicated that the child has severe cerebral palsy (due to an abruption at birth). The child is competely homebound and requires total care. Also, his concomitant therapy at the time of vaccination included Tegretol, Clonopine, Rhinocort and albuterol. It was reported that the patient has a long term history of intermitent steroid use due to his severe reactive airway disease, but he was not actually on steroids at the time of vaccination. As of of 08-OCT-1998 the patient was in the middle of a steroid taper, which was completed on approximately 15-OCT-1998. On 22-OCT-1998 the child had been off steroids for a week and was vaccinated with VARIVAX.  He started again on steroids on 29-OCT-1998 and on 09-NOV-1998 he presented to the doctor's office with lesions and subsequently was hospitalized due to VZV pneumonia. Follow-up information from a physician reported that on 22-OCT-1998, the patient was vaccinated with a dose of Influenza virus vaccine. In addition, it was reported that the patient was hospitalized from 09-NOV-1998 through 02-JAN-1999. While hospitalized, the patient received three transfusions. Subsequently, the patient recovered. Additional follow-up information from a physician reported that the patient's usual dose of steroid was 1-2 mg/kg/day (2 tsps BID) of Pediapred. On 29-OCT-1998, the patient was again started on 1-2 mg/kg/day (2 tsps) of Pediapred twice daily for 5 days. Subsequently in October 2003, the patient's experience was also reported in a published literature article. The article also mentioned three other patient's (WAES # 96031140, 98101671 and 00120881) with similar experiences following exposure to VARIVAX. No further information is available.			Y		Y	58	Y		Y	10/22/1998	11/09/1998	18	endotracheal aspirate-VZV+; DFA for VZV strongly +; PCR=Oka strain id; DFA for CMV, HSV, RSV, flu A/B=all neg; urine=pos for candida albicans; CXR pos for linglular pneumo w/ patchy infiltrate; Blood transfusion, platelets, packed cells, fresh frozen plasma; Chest X-ray, 11/09/98, lingular pneumonia, represent a current inflammatory process, Diagnostic laboratory, 11/09/98, viral culture-no virus isolated; Chest X-ray, 11/15/98, serial worsening: diffuse patchy infiltrates in both lungs: could represent varicella pneumonia; Diagnostic laboratory, 11/19/98, pneumocystis silver stain negative; Diagnostic laboratory 11/16/98, fungus culture-Candida albicans; Blood culture, 11/09/98, no growth after 5 days; Laboratory test, 11/17/98, endotracheal aspirate VZV postivie; Laboratory test, 11/17/98?, PCR analysis of endotracheal aspirate- VZV positive; Urine culture, 11/29/98, Candida albicans; Throat culture, 11/15/98, usual oropharyngeal flora; Laboratory test, 11/17?/98, PCR anylasis- oka strain identified; Laboratory test, 11/17/98, negative for mycoplasm IgM; Blood culture, 11/15/98, no  growth after 5 days; Gram stain, 11/15/98, rare pus cells, epethelial cells, few gram positive cocci, rare gram neg. bacilli; Laboratory test, 11/17?/98, DFA for VZV strongly positive; laboratory test, 11/17?/98, DFA for CMV, HSV, flu A and B and RSV all negative; Blood culture, 12/05/98, no growth in 4 weeks	UNK	UNK	Albuterol;Rhinocort;Tegretol;Clonopin;Pediapred;		cerebral palsy;reactive airway disease;steroid therapy;	No Relevant data~ ()~~0.00~Patient	WAES98111367	1						1	Candidiasis; Chest X-ray abnormal; Culture urine positive; Diffuse alveolar damage; Drug ineffective; Hypoxia; Infection; Pneumonia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~~UNK~~~VARICELLA (VARIVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0124246	05/21/1999	PA	4.0	4		F	05/14/1999	approx 30mos p/vax pt exp chickenpox w/approx 30 lesions, fever 99.7f									Y	05/20/1996	11/19/1998	913		OTH	OTH			reactive airway disease	no relevant data~ ()~~~In patient	WAES98111563	1						1	Drug ineffective; Infection; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~0392B~1~SC~~VARICELLA (VARIVAX)~1	USA		Influenza
0122388	05/24/1999	PA	66.0	66		F	05/20/1999	started w/arthritis in spine & legs-inflammation of muscles all over body;taking steroids, now inflammation in nerves-trouble walking-pain in groin, pain/weakness in legs-pain @ inj site;				Y	Y	2			N	11/10/1998	11/20/1998	10	x-rays, MRI, mammogram, blood work, pap smear;	OTH	OTH	Prempro	NONE	allergic to some meds, contrast dye, ASA, Dx w/ early stage of leukemia-platelet problem; back pain	NONE~ ()~~~In patient		1						1	Anaemia; Arthritis; Back pain; Condition aggravated; Hypokinesia; Injection site pain; Myalgia; Myasthenic syndrome; Neuritis; Pain; Pelvic pain; Red blood cell sedimentation rate increased; Thrombocytopenia	FLU3~CONNAUGHT LABORATORIES~0967040~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0122394	05/24/1999	MD	38.0	38		F	04/21/1999	Stenger test negative 6-8000 Hz, profound high range hearing loss in lt ear; constant tinnitus; dx -immune reactive 8th nerve damage; Annual follow-up states the pt has not yet recovered.				Y				Y	N	10/05/1998	10/14/1998	9	MRI-no abnormalities, audiogram, full ENT & Neuro exam;	MIL	MIL		NONE	allergy to ASA & Bees; fibromyalgia, chronic fatigue; MVA w/ L5-S1 disc protrusion (not contacting  neural elements)			1						1	Deafness; Immune system disorder; Neuropathy; Paraesthesia; Tinnitus; Vestibular disorder	FLUX~UNKNOWN MANUFACTURER~~4~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~~~PNEUMO (NO BRAND NAME)~1	USA	Disabling	Influenza
0123195	06/01/1999	MA	68.0	68		M	05/06/1999	body ache;3wk started w/extreme fatigue;chills, dizziness;				Y					Y	10/20/1998	11/10/1998	21	blood test & x-rasy @ hosp all test negative;	PUB	PUB		NONE	liver surgery (2/3 removed) 3yrs ago carolis synd	NONE~ ()~~~In patient	MA9907	1						1	Asthenia; Chills; Dizziness; Myalgia	FLU3~CONNAUGHT LABORATORIES~0975780~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0115552	06/07/1999	FL	42.0	42		M	05/27/1999	3 days p/vax pt exp abdominal pain after eating. also stated pt recv a bullet wound to stomach about 5wks ago. under went surgery but bullet not removed									Y	10/15/1998	10/18/1998	3	none rpt	OTH	OTH			allergies: PCN, injury from other bullets	~ ()~~~In patient	MPI981963	1						2	Abdominal pain	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0116098	06/07/1999	DC	50.0	50		M	05/27/1999	72 hrs p/vax pt exp fever101f, chills, & muscles aches. 4 days p/vax pt exp fever 106f, malaise, chills & muscle aches.										10/22/1998	10/25/1998	3	none rpt	OTH	OTH				~ ()~~~In patient	MPI981958	1						2	Chills; Malaise; Myalgia; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~20118GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0116220	06/07/1999	LA	34.0	34		F	05/27/1999	the day following vax pt exp itching, pain @ inject site, hives, urticaria down arm & on back a swollen right eye. also swelling to right upper eyelid & left lower lid, general itching, some shortness of breath w/tightness.sx lasted 3days.									Y	11/02/1998	11/03/1998	1	none rpt	OTH	OTH			back surgery, L5-S1; disorders of gallbladder	~ ()~~~In patient	MPI981978B	1						2	Chest pain; Dyspnoea; Eye disorder; Face oedema; Injection site pain; Pruritus; Urticaria	FLU3~MEDEVA PHARMA, LTD.~20158HF~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0116222	06/07/1999	LA	35.0	35		F	05/27/1999	p/recv vax pt exp swelling the size of baseball at inject site, reduced in size to small knot @ time of rpt. f/u rpt indicates pt exp pain & redness. sx resolved p/9 days									Y	10/30/1998	10/30/1998	0	none rpt	OTH	OTH			allergies: coritsone	~ ()~~~In patient	MPI981978A	1						2	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain	FLU3~MEDEVA PHARMA, LTD.~20158HF~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0123348	06/07/1999	MI	52.0	52		F	02/26/1999	after vax pt devel local react, numb lips, lightheadedness/returned at intervals approx. 8 hours apart x3 days. also exp pain, within 15 min.  above clavicles lasting 2 hours and would also return at intervals. inject site redness/itching/swelling would also come and go. Prior to the shot I ate eggs without allergy. In the past 3 wks I've had eggs 3 times and experienced nasal congestion, diarrhea, cramps and nausea. I respond to MSG and sulfates this way. 6/1/99 states was recently skin tested for allergy to eggs. Showed sensitivity, not true allergy. Follow up information received at Aventis Pasteur Inc on April 8, 2002 reported that the patient recovered from this experience. No further information is expected. This case is closed.									Y	11/27/1998	11/27/1998	0		PVT	PVT	Ojen, Flovent, Serevent, inhalers, Flonase, Rhinocort nasal inhalers		asthma & allergy to feathers		U199900123	1						1	Chest pain; Diarrhoea; Diarrhoea; Dizziness; Dizziness; Hypersensitivity; Hypoaesthesia oral; Injection site erythema; Injection site hypersensitivity; Injection site oedema; Injection site pruritus; Injection site swelling; Muscle spasms; Nasal congestion; Nausea; Paraesthesia oral; Pruritus; Rhinitis	FLU3~CONNAUGHT LABORATORIES~0984540~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0123373	06/07/1999	AK	19.0	19		M	05/30/1999	after recv vax pt exp 10 cm circle of erythema 7 swelling around site, temp 100 by mouth. had night sweats & body aches.									Y	05/27/1999	05/28/1999	1	none	PVT	UNK		none	none	~ ()~~~In patient		1						1	Hyperhidrosis; Injection site hypersensitivity; Injection site oedema; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0973980~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1402H~1~IM~~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~0998960~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0124843	06/07/1999	CA	54.0	54		F	06/04/1999	pt recv skin test w/vax.& described react area 1.5inx3in that swelled, red, hot & itchy. sx lasted 1wk. f/u w/vax MD provided no addl info until yr later. no records of Fluvirin administration									Y	10/01/1994	10/01/1994	0	none rpt	OTH	OTH	motrin/ibuprofen, synthroid/levothyroxine sodium		allergies: Hx of allergy to methylparavben preservative; no allergy to eggs	~ ()~~~In patient	MPI98652	1						1	Unevaluable event	FLU3~MEDEVA PHARMA, LTD.~E2504GC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124844	06/07/1999	MO	78.0			M	05/27/1999	p/vax pt exp night sweats, weakness in arms, pain in neck radiating through back of head. MRI rpt neg but pos for degenerative joint disease in neck									N	10/13/1997			none rpt	OTH	OTH	aspirin/aspirn, hydrochlorothiazide/hydrochlor, iopidine/appaclonidine, timoptol/timolol maleate		none rpt	~ ()~~~In patient	MPI98900	1						1	Arthropathy; Headache; Hyperhidrosis; Myasthenic syndrome; Neck pain	FLU3~MEDEVA PHARMA, LTD.~7581860~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124848	06/07/1999	NJ	48.0	48		F	05/28/1999	p/pt recv 2 vax exp generalized itching, felt hot all over, & devel lumps at site. within 2-3hrs pt devel swelling, pain at pnu-immune inject site. 3nov97, painful area of ecchymosis devel @ pnu-immune inject site.									Y	10/31/1997	10/31/1997	0	none rpt	UNK	UNK	claritin, d/loratadine		allergic to codeine, asthma	~ ()~~~In patient	MPI981519	1						1	Ecchymosis; Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Pruritus; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E32779A~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~444068~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0124850	06/07/1999	NJ	24.0	24		M	05/27/1999	p/vax pt devel pruritus & began on arms & back of knees, spread over entire body. rash continues to worsen. treated w/prednisone									U	09/13/1998	09/13/1998	0	none rpt	OTH	OTH			none rpt	~ ()~~~In patient	MPI981755	1						1	Pruritus; Rash	FLU3~MEDEVA PHARMA, LTD.~20088GD~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124851	06/07/1999	IN	49.0	49		U	05/27/1999	p/pt recv vax pt exp high fever, 104.3f									Y	09/29/1998			none rpt	OTH	OTH	carboplatintaxol/paclitaxel		allergic: keflex	~ ()~~~In patient	MPI981880	1						1	Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E20178HE~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~454976~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0124853	06/07/1999	TX				F	05/27/1999	p/recv vax pt exp severe pain on arm. MD hypothesized vax given on deltoid close to the joint. pt referred to orthopedic MD									U	10/01/1998			none rpt	OTH	OTH			none rpt	~ ()~~~In patient	MPI981896	1						1	Pain	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124854	06/07/1999	ID	41.0			U	05/27/1999	2hrs p/vax pt exp dizziness, tingling lips, weakness in upper body & nausea.									Y	10/14/1998	10/14/1998	0	none rpt	OTH	OTH			none rpt		MPI981909A	1						1	Dizziness; Myasthenic syndrome; Nausea; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~20218HB~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124855	06/07/1999	ID	56.0			F	05/27/1999	15min p/vax pt exp dizziness, tingling lips, left arm pain neck to shoulder & nausea.									U	10/14/1998	10/14/1998	0	none rpt	OTH	OTH			none rpt	~ ()~~~In patient	MPI981909B	1						1	Dizziness; Nausea; Neck pain; Pain; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~20218HB~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124856	06/07/1999	ID	32.0			U	05/27/1999	within half hr of vax pt exp dizziness, tingling lips, weakness in upper body & nausea.									Y	10/14/1998	10/14/1998	0	none rpt	OTH	OTH			none rpt	~ ()~~~In patient	MPI981909C	1						1	Dizziness; Myasthenic syndrome; Nausea; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~20218HB~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124857	06/07/1999	PA				F	05/27/1999	it was rpt fr MD p/vax pt exp numbness down arm into fingers. 24hrs p/vax pt inject site was swollen & red approx 3-4'' wide. sx lasted 3 days.									Y	10/01/1998			none rpt	OTH	OTH			none rpt		MPI981910A	1						1	Injection site hypersensitivity; Injection site oedema; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~20138HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124858	06/07/1999	PA				F	05/27/1999	at time vax pt exp pain at inject site. the day p/vax pt exp swelling in lymph nodes under arm where injected. has cough lasted about 3wks									Y	10/01/1998				OTH	OTH			none rpt	~ ()~~~In patient	MPI981910B	1						1	Cough; Injection site pain; Lymphadenopathy	FLU3~MEDEVA PHARMA, LTD.~20138HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124859	06/07/1999	PA				F	05/27/1999	the day of vax pt exp swelling & redness at inject site approx 1.5''. sx lasted 3-4 days.										10/01/1998			none rpt	OTH	OTH			none rpt	~ ()~~~In patient	MPI981910C	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~MEDEVA PHARMA, LTD.~20138HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124860	06/07/1999	PA	44.0	44		F	05/27/1999	immed following vax pt redness & a couple of days later bruising at inject site. f/u pt exp redness & tender pancake-like swelling at inject site.									Y	10/01/1998			none rpt	OTH	OTH			allergic zomax, elevatedblood pressure reading without diag of hypertension	~ ()~~~In patient	MPI981911	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124861	06/07/1999	VA				U	05/27/1999	a couple of days p/vax pt exp some redness & pain in arm radiating up into neck. treated w/tylenol									U	10/01/1998			none rpt	OTH	OTH			none rpt	~ ()~~~In patient	MPI981912	1						1	Injection site hypersensitivity; Injection site pain; Neck pain	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124862	06/07/1999	NC	62.0	62		F	05/27/1999	day p/vax pt exp rash under skin @ inject site & back. itching occurred 6 hrs of recv vax. treated w/hydroxyzine.									Y	10/09/1998	10/10/1998	1	none rpt	OTH	OTH			allergies: benadryl	~ ()~~~In patient	MPI981913	1						1	Pruritus; Rash	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124865	06/07/1999	GA	30.0			F	05/27/1999	a few hrs p/vax pt exp rash on ear & just below neck.									Y	10/26/1998	10/26/1998	0	none rpt	OTH	OTH			none rpt	~ ()~~~In patient	MPI981943	1						1	Rash	FLU3~MEDEVA PHARMA, LTD.~20088GD~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124866	06/07/1999	IL	44.0			M	05/28/1999	p/vax pt devel generalized aching & felt warm. pt felt electric shock pain just below the replaced (left knee) joint, pain was described as almost tingling & numb.treated w/heat & cold.									U	10/23/1998	10/23/1998	0	none rpt	OTH	OTH			knee replacement		MPI981944	1						1	Myalgia; Pain; Paraesthesia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124868	06/07/1999	MD				F	05/27/1999	p/recv vax pt devel red, hard area the size of peach on the back of the arm. arm was still swollen 5days p/vax									N	10/14/1998			none rpt	OTH	OTH			none rpt	~ ()~~~In patient	MPI981951	1						1	Oedema peripheral; Rash; Skin nodule	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124869	06/07/1999	PA	76.0			M	05/27/1999	p/recv vax pt exp a hard lump size of quarter. further info requested									U	10/16/1998			none rpt	OTH	OTH			none rpt	~ ()~~~In patient	MPI981953A	1						1	Skin nodule	FLU3~MEDEVA PHARMA, LTD.~20208KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124870	06/07/1999	PA	26.0			F	05/27/1999	p/vax pt exp hard lump the size of quarter.further info requested									U	10/16/1998			none rpt	OTH	OTH			none rpt	~ ()~~~In patient	MPI981953B	1						1	Skin nodule	FLU3~MEDEVA PHARMA, LTD.~20208KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124871	06/07/1999	DC	51.0			F	05/27/1999	p/recv vax pt exp local react in arm described as 1.5'' in diameter & itchy.									U	10/14/1998			none rpt	OTH	OTH			none rpt	~ ()~~~In patient	MPI981954	1						1	Injection site reaction; Pruritus	FLU3~MEDEVA PHARMA, LTD.~E20218HC~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124872	06/07/1999	FL	62.0	62		M	05/27/1999	day p/vax pt exp blurred vision, dizziness & flue like sx lasting 2days. pt felt as though he was suffocating									Y	10/19/1998	10/20/1998	1	none rpt	OTH	OTH			none rpt	~ ()~~~In patient	MPI981955	1						1	Amblyopia; Dizziness; Dyspnoea; Influenza	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124873	06/07/1999	PA				F	05/27/1999	p/recv vax pt exp a bruise at inject site w/red streaks halfway down arm.									U	10/21/1998			none rpt	OTH	OTH			none rpt	~ ()~~~In patient	MPI981957	1						1	Ecchymosis; Injection site reaction; Skin striae	FLU3~MEDEVA PHARMA, LTD.~20158HD~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124875	06/07/1999	NC	70.0			F	05/27/1999	p/vax pt exp nausea, sx resolved p/2days									Y	10/20/1998	10/20/1998	0	none rpt	OTH	OTH			none rpt	~ ()~~~In patient	MPI981959	1						1	Nausea	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124876	06/07/1999	NY	79.0	79		M	05/27/1999	2days p/recv vax pt devel a pinpoint rash on back & front of trunk,  arms, legs.									U	10/21/1998	10/23/1998	2	none rpt	OTH	OTH			none rpt	~ ()~~~In patient	MPI981960	1						1	Rash	FLU3~MEDEVA PHARMA, LTD.~20098GB~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124877	06/07/1999	MD	55.0			M	05/27/1999	p/vax pt exp a rash on upper chest, face, neck, back & both arms, also felt hot within 1hr following vax then recurred the following day.									U	10/21/1998	10/22/1998	1	none rpt	OTH	OTH	niacin		none rpt	~ ()~~~In patient	MPI981961	1						1	Rash; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~20118GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124879	06/07/1999	WI	26.0	26		F	05/27/1999	6hrs p/vax pt exp heaviness of breathing, redness of area of site, generalized rash over entire body.									U	10/28/1998	10/29/1998	1	none rpt	OTH	OTH			allergies: pencillin	~ ()~~~In patient	MPI981965	1						1	Dyspnoea; Injection site hypersensitivity; Rash	FLU3~MEDEVA PHARMA, LTD.~20188HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124880	06/07/1999	IA	68.0	68		F	05/27/1999	p/recv vax pt exp a red, swelling to axilla, a lot of pain & edema. sx continuing 2days p/vax. f/u info recv devel through night edema, pain & redness at inject site & fever,									Y	10/28/1998	10/28/1998	0	none rpt	OTH	OTH			none rpt	~ ()~~~In patient	MPI981966	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Lymphadenopathy; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~20198HC~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124881	06/07/1999	VA				F	05/27/1999	p/recv vax pt exp stiff sore neck & swollen glands. further info requested									Y	10/23/1998	10/23/1998	0	none rpt	OTH	OTH			none rpt	~ ()~~~In patient	MPI981967	1						1	Unevaluable event	FLU3~MEDEVA PHARMA, LTD.~20198HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124882	06/07/1999	GA	58.0	57		F	05/27/1999	the day following vax pt described react event size of silver dollar getting redness slightly itchy & tender  & heavy, but not painful, on left arm inject site.									Y	10/26/1998	10/27/1998	1	none rpt	OTH	OTH	premarin, conjugated, provera, medroxyprogesterone, synthroid, levothyroxine sodium tenormin, atenolol		allergies: codiene & ceclor	~ ()~~~In patient	MPI981971	1						1	Injection site hypersensitivity; Injection site pain; Pruritus	FLU3~MEDEVA PHARMA, LTD.~20218HB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124883	06/07/1999	TN	56.0			M	05/27/1999	approx 2hrs p/vax pt exp headache, nausea, sore abdomen, tiredness, achy bones & diarrhea.									Y	10/27/1998	10/27/1998	0	none rpt	OTH	OTH			none rpt		MPI981972	1						1	Abdominal pain; Arthralgia; Asthenia; Diarrhoea; Headache; Infection; Influenza; Myalgia; Nausea	FLU3~MEDEVA PHARMA, LTD.~20248KC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124884	06/07/1999	CA	31.0	31		F	05/27/1999	p/recv vax pt exp burning in antecubital space, chest & same arm of inject site, later tender lymph nodes under arm some 5days later.									N	10/29/1998	10/29/1998	0	none rpt	OTH	OTH			none rpt	~ ()~~~In patient	MPI981974	1						1	Lymphadenopathy; Pain	FLU3~MEDEVA PHARMA, LTD.~20188HB~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124887	06/07/1999	LA				U	05/27/1999	p/recv vax pt exp localized inject site react w/o other sx									U	10/01/1998	10/01/1998	0	none rpt	OTH	OTH			none rpt	~ ()~~~In patient	MPI981978C	1						1	Injection site reaction	FLU3~MEDEVA PHARMA, LTD.~20158HF~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124889	06/07/1999	MA	47.0	47		M	05/27/1999	p/recv vax pt exp nausea & 18 days later pt exp chills, fever, abd pain, joint pain & loose stool continuing 2 days later.									N	10/15/1998	10/15/1998	0	none rpt	OTH	OTH			none rpt	~ ()~~~In patient	MPI981981	1						1	Abdominal pain; Arthralgia; Chills; Diarrhoea; Nausea; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~20238KD~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124890	06/07/1999	TX				F	05/27/1999	p/vax pt exp swollen lips which lasted several days;									Y	10/01/1996	10/01/1996	0	NONE	OTH	OTH			NONE	~ ()~~~In patient	MPI981982	1						1	Face oedema; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124891	06/07/1999	FL	50.0	50		F	05/27/1999	p/vax pt exp an inj site rxn described as itching, red & swelling, 2 days p/vax;tx w/DPH;pt did not c/o any sickness;allergy to pollen;arm was reported to have got hot to touch & an unbearable itch & swollen 1/2 way down top part of arm;									Y	11/06/1998	11/08/1998	2	NONE	OTH	OTH	Hormone therapy/hormone		allergies: allergic to sulfa drugs, pollen	~ ()~~~In patient	MPI981984	1						1	Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Pruritus; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20198HB~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124893	06/07/1999	PA	40.0			M	05/27/1999	p/vax pt exp dimples & yellowing around the site p/vax;pt exp yellow/whitehead pimples around inj site w/some itching;									Y	11/06/1998	11/07/1998	1	NONE	OTH	OTH			Kithotripsy status: hx of	~ ()~~~In patient	MPI981990	1						1	Injection site hypersensitivity; Pruritus	FLU3~MEDEVA PHARMA, LTD.~20238KC~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124894	06/07/1999	PA	7.0			F	05/27/1999	p/vax pt broke out in hives (itchy) @ inj site the day p/vax;tolerated other vaccines in the past & does not have a known allergy to eggs;the reporting MD thought the rxn was caused by the vaccine;									U	10/01/1998	10/01/1998	0	NONE	OTH	OTH			NONE	~ ()~~~In patient	MPI981991	1						1	Pruritus; Urticaria	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124899	06/07/1999	CA	49.0			F	05/27/1999	p/vax pt exp fever, sore throat & aches & pains 13 days p/vax;pt is still achy today;pt suffered from fever, sore throat & gen aches 13 days p/vax;									Y	11/03/1998	11/16/1998	13	NONE	OTH	OTH			NONE		MPI982007B	1						1	Arthralgia; Myalgia; Pain; Pharyngitis; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~20128GC~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124900	06/07/1999		54.0	54		F	05/27/1999	p/vax pt exp a strange shutter throughout body;also exp pressure @ the base of skull;sx cont the next hr but then pt started to feel weak;also reports feeling uncoordinated, legs feeling like going to buckle & going to fall & feeling heavy									Y	10/24/1998	10/24/1998	0	NONE	OTH	OTH			NONE	~ ()~~~In patient	MPI982013	1						1	Asthenia; Coordination abnormal; Hypertonia; Myasthenic syndrome; Pain; Paraesthesia; Thinking abnormal; Tremor	FLU3~MEDEVA PHARMA, LTD.~20248KD~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124901	06/07/1999	GA	64.0			M	05/27/1999	pt exp flu like sx consisting of fever, chills, cough & runny nose 2 days p/vax;									Y	10/23/1998	10/25/1998	2	NONE	OTH	OTH			NONE	~ ()~~~In patient	MPI982017A	1						1	Chills; Cough; Influenza; Pyrexia; Rhinitis	FLU3~MEDEVA PHARMA, LTD.~20248KD~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124902	06/07/1999	GA	56.0			F	05/27/1999	p/vax pt exp a warm & sore arm, nausea & fever;									Y	10/23/1998	10/24/1998	1	NONE	OTH	OTH			NONE	~ ()~~~In patient	MPI982017B	1						1	Nausea; Pain; Pyrexia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~20248KD~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124903	06/07/1999	NJ	77.0			F	05/27/1999	p/vax pt exp T99.7 (taken at home) & 100.9 (@ MD office), lt arm that was swollen, red & painful to touch (dx cellulitis);tx w/ATB;									U	10/20/1998	10/21/1998	1	NONE	OTH	OTH	Hormone therapy/hormone		10/27/98 bone recurrence;10/27/98 breast cancer;10/27/98 mastectomy;	~ ()~~~In patient	MPI982018A	1						1	Cellulitis; Oedema peripheral; Pain; Pyrexia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~2028HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124904	06/07/1999	NJ	66.0			F	05/27/1999	pt exp a 1 in weal around inj site (erythema & swelling @ inj site) a few minutes p/vax;sx were treated w/warm compresses;pt is undergoing chemotherapy & has had radiation in the past for breast cancer;									Y	10/22/1998	10/22/1998	0	NONE	OTH	OTH			Breast Cancer undergoing chemotherapy;has had radiation in the past;	~ ()~~~In patient	MPI982018B	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~MEDEVA PHARMA, LTD.~20208HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124905	06/07/1999	WI	29.0	29		F	05/27/1999	p/vax pt felt jittery,buzzed as though had too much caffeine;pt exp jittery, jumpy as if high on caffeine;									Y	10/26/1998	10/26/1998	0	NONE	OTH	OTH	Zoloft/Sertraline		allergies: sulpha-rash;10/27/98 depression; laporoscopy w/ovarian cyst removal, also in MAR91;hx of tubal ligation laporoscopic tubal ligation;appendectomy;spontaneous miscarriage;chryosurgery for cervical cancer;arthroscopic knee surgery;	~ ()~~~In patient	MPI982019	1						1	Anxiety; Tremor	FLU3~MEDEVA PHARMA, LTD.~20248KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124906	06/07/1999	IN	57.0	57		F	05/27/1999	p/vax pt exp fever, h/a, feeling shaky & weak;had arm soreness approx 5 days;T>101;reporting MD indicated felt sx could be d/to both vax being given @ same site;									Y	09/26/1998	09/27/1998	1	NONE	OTH	OTH	Pneumovax II/pneumococcal		NONE	~ ()~~~In patient	MPI982020	1						1	Asthenia; Headache; Pain; Pyrexia; Tremor; Asthenia; Headache; Pyrexia; Tremor; Headache; Myalgia; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~20178HB~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~~1~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~~1~~~PNEUMO (PNEUMOVAX)~2|FLU3~MEDEVA PHARMA, LTD.~E20178HB~UNK~~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~3|PPV~UNKNOWN MANUFACTURER~1095H~UNK~~LL~PNEUMO (NO BRAND NAME)~3	USA		Influenza
0124908	06/07/1999	NE	50.0	50		M	05/27/1999	p/vax pt exp swelling eyes/fluid filled, welts on face & ears, bumps on neck, burning sensation & itching;tx w/corticosteroids w/o success;patch testing revealed a hypersensitivity to thimerosal;									U	11/08/1998	11/12/1998	4	skin patch test hypersensitivity to thiomersal, balsam of perm & neomycin;	OTH	OTH			allergies: allergic contact dermatitis, positive to patch tests to: thimersol, balsam of perm, noemycin;	~ ()~~~In patient	MPI982024	1						1	Dermatitis bullous; Eye disorder; Face oedema; Hypersensitivity; Pain; Pruritus; Rash maculo-papular	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124910	06/07/1999	NY	50.0			M	05/27/1999	p/vax pt exp h/a & flu like sx a few hr p/vax;									Y	12/02/1998	12/02/1998	0	NONE	OTH	OTH			NONE	~ ()~~~In patient	MPI982043A	1						1	Headache; Influenza	FLU3~MEDEVA PHARMA, LTD.~20248KF~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124911	06/07/1999	NY				U	05/27/1999	p/vax pt exp h/a & flu like sx;									Y	12/02/1998	12/02/1998	0	NONe	OTH	OTH			NONE	~ ()~~~In patient	MPI982043B	1						1	Headache; Influenza	FLU3~MEDEVA PHARMA, LTD.~20248KF~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124912	06/07/1999	IL	48.0			F	05/27/1999	p/vax pt exp widespread body rash & moderate itching (rash not raised);									Y	11/16/1998	11/19/1998	3	NONE	OTH	OTH			allergies: similar rxn several years prev to amoxycillin	~ ()~~~In patient	MPI982044	1						1	Pruritus; Rash	FLU3~MEDEVA PHARMA, LTD.~20218HB~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124913	06/07/1999	IL				F	05/27/1999	p/vax pt exp severe myalgia 6hr post vax;ibuprofen taken but had no effect;									Y	10/01/1998	10/01/1998	0	NONE	OTH	OTH			NONE	~ ()~~~In patient	MPI982045A	1						1	Myalgia	FLU3~MEDEVA PHARMA, LTD.~E20238KD~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124914	06/07/1999	IL				U	05/27/1999	p/vax pt exp knee arthralgia;									U	10/01/1998	10/01/1998	0	NONE	OTH	OTH			NONE	~ ()~~~In patient	MPI982045B	1						1	Arthralgia	FLU3~MEDEVA PHARMA, LTD.~20238KD~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124916	06/07/1999	PA	9.0	9		M	05/27/1999	p/vax pt exp facial swelling & hives all over the day;12-15hr p/vax pt awoke w/facial swelling, eyes swollen & closed & hives covering entire body;									Y	12/09/1998	12/10/1998	1	NONE	OTH	OTH	Intal inhaler/inhaler;Proventil;Albuterol sulfate;Singulair/singulair;Vancenase/Beclomethasone;		allergies; asthma status ongoing;	~ ()~~~In patient	MPI982068	1						1	Eye disorder; Face oedema; Urticaria	FLU3~MEDEVA PHARMA, LTD.~20138HE~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124917	06/07/1999	MA	9.0	9		F	05/27/1999	p/vax pt exp hives, angioedema & abd pain;confirmed urticarial vasculitis;									N	11/17/1998	11/17/1998	0	NONE	OTH	OTH			allergic rhinitis status ongoing;asthma status ongoing;unspecified hypothyroidism status ongoing hypothyroid w/thyroid auto antibodies;	~ ()~~~In patient	MPI982092	1						1	Abdominal pain; Angioneurotic oedema; Urticaria; Vasculitis	FLU3~MEDEVA PHARMA, LTD.~20298LA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124918	06/07/1999	PA	45.0	44		M	05/27/1999	p/vax pt blood test showed elevated liver enzymes;apparently was being denied a preferential rate for insurance;A physical & blood work done the prev month was fine;									Y	11/01/1998	11/07/1998	6	NONE	OTH	OTH			NONE	~ ()~~~In patient	MPI982093	1						1	Hepatic function abnormal	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124919	06/07/1999	TX	60.0	60		F	05/27/1999	p/vax pt devel a fever & hives;this was followed by confusion & rage accompanied by destructive behavior & similar actions;									U	12/11/1998	12/11/1998	0	NONE	OTH	OTH			NONE	~ ()~~~In patient	MPI982094	1						1	Confusional state; Hostility; Personality disorder; Pyrexia; Urticaria	FLU3~MEDEVA PHARMA, LTD.~20318LA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124927	06/07/1999	FL				M	05/27/1999	p/vax pt exp flu sx, joint, hand, wrist & knee discomfort, lost energy, thrush of mouth, pain in hips & arch of feet;already present sinus infect;pt came down w/flu;									N	10/01/1998	10/01/1998	0	12/15/98 WBC, platelets 433000;1/7/99 sed rate 129 & 243;CH 50 8.6 & 0.8;bilirubihn & phos sed rate 27;test for arthritis negative;	OTH	OTH	Pneumovax/pneumococcal vaccine;		12/15/98 sinus infect status ongoing; blocked ears status ongoing;	~ ()~~~In patient	MPI199900035	1						1	Arthralgia; Asthenia; Influenza; Oral candidiasis; Pain; Arthralgia; Asthenia; Condition aggravated; Influenza; Laboratory test abnormal; Pain; Red blood cell sedimentation rate increased; Sinusitis; Thrombocythaemia	FLU3~MEDEVA PHARMA, LTD.~201584A~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0124929	06/07/1999	FL	62.0			F	05/27/1999	p/vax pt flu like sx started;									U	10/30/1998	10/30/1998	0	NONE	OTH	OTH			NONE	~ ()~~~In patient	REG199900038	1						1	Influenza	FLU3~MEDEVA PHARMA, LTD.~E20248K~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0124694	06/14/1999	TX	31.0	31		M		fever & mild upper airway sx, then lower resp problems w/dec 02;dx influenza, r/o pneumonia;deteriorated;required intubation, ventilation support;dx pneumococcal pneumonia;devel shock, father req no aggressive tx-pt died; father ref autopsy	Y	03/21/1999							N	11/01/1998	02/20/1999	111	COD influenza complicated by pneumococcal pneumonia;2/23/99 WBC 6.4, 19% bands;2/24/99 WBC 7.3, 18% bands;CXR showed hazy lt lower lung base;3/17/99 tracheostomy performed;	OTH	PUB				~ ()~~~In patient	TX99112	1						1	Drug ineffective; Hypoxia; Infection; Lung disorder; Pneumonia; Pyrexia; Respiratory disorder; Shock	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0124791	06/15/1999	OH	73.0	73		F	06/08/1999	had palpitations lightheaded about 1:00 on 10/28/98 MD called;MD upset w/BP reading ordered pt to ER;				Y					Y	10/23/1998	10/28/1998	5		OTH	UNK			high blood presuure-controlled w/vaseretic	~ ()~~~In patient		1						1	Dizziness; Palpitations	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0124939	06/17/1999	GA	56.0	56		F	06/14/1999	1 day p/vax pt exp severe flu like sx for next 6-7 days;pt notice rise in home monitored blood sugar level >300 to 400;pt exp swelling in both great toes;saw MD & determined to have bone disease;toes damaged & gangrene;great toes amputated;				Y				Y	N	11/01/1998	11/02/1998	1	bone scan positive for bone disease;later positive cult for staph	UNK	UNK	Amaryl	Diabetes	pt has a 5 year hx of non-insulin dependent diabetes		U199900397	1						1	Bone disorder; Condition aggravated; Gangrene; Hyperglycaemia; Infection; Influenza; Oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0124955	06/17/1999	LA	31.0	31		F	06/09/1999	pt devel nausea & vomiting 2 days p/vax;pt came to tx room on 10/24/98;phenergan tablets given;				Y					Y	10/20/1998	10/22/1998	2		OTH	OTH	NONE	possible tubal pregnancy (unk)	multiple sclerosis	~ ()~~~In patient		1						1	Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0118422	06/18/1999	FL	63.0	63		M	06/16/1999	pt devel flu;exp joint discomfort & loss of energy;treated w/ ATB;devel thrush, tx=pred;pt c/o persistent sinus infection-box 18; f/u w/ MD:devel fever/chills/diarrhea/ fatigue/weakness/joint ache;hosp on/off;dx Wegener' granulomatosis; Annual follow-up received on 11/27/00 states that the pt has recovered. No additional data provided.			Y	Y	Y			Y	Y	11/23/1998	11/25/1998	2	12/15/98-total serum protein=8.6, platelets=433,000, ESR=37;1/7/99 ESR=129;	UNK	UNK	unspecified antibiotics	external otic obstruction;sinusitis	unk		WAES99041032	1						2	Anaemia; Arthralgia; Blood alkaline phosphatase increased; Blood creatinine increased; Blood urea increased; Chills; Granuloma; Hyperbilirubinaemia; Hyperglycaemia; Hyperkalaemia; Hypokinesia; Influenza; Laboratory test abnormal; Leukocytosis; Pain; Protein bound iodine increased; Pyrexia; Red blood cell sedimentation rate increased; Renal failure; Thrombocythaemia; Arthralgia; Asthenia; Chills; Diarrhoea; Granuloma; Influenza; Laboratory test abnormal; Oral candidiasis; Pyrexia; Red blood cell sedimentation rate increased; Thrombocythaemia	FLU3~MEDEVA PHARMA, LTD.~E201584A~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1173E~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~MEDEVA PHARMA, LTD.~E201584A~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~1173E~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0125084	06/22/1999	MT	72.0	71		M	06/14/1999	p/vax pt was hosp w/an upper resp infect;					Y	3			Y	10/20/1997	01/22/1998	94	influenza A swab positive on 1/23/98	PVT	OTH			NONE	~ ()~~~In patient	U199900393	1						1	Infection; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~7F81832~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0125165	06/25/1999	TN	74.0			F	06/07/1999	p/vax pt devel difficulty swallowing, and progressive weakness, could not walk;exp acute flu like sx;Dx=myasthenia gravis;devel steroid myopathy  & aseptic necrosis of hips;pred d/c & difficulty speaking, swallowing & walking  Doc # 197836 states that report was cancelled based on correspondance received from the vaccine provider.				Y	Y			Y	N	10/24/1997	11/01/1997	8	myasthenia panel: borderline''; Electrophysiological studies: could not be confirmatory''	PVT	OTH	unk	unk	hypothroidism, dyspepsia w/intermittent gastroesophageal reflux, cardiomyopathy, CHF, chronic atrial fib w/ atrial thrombus		899159114A	1						1	Asthenia; Bone disorder; Dysphagia; Hypokinesia; Myasthenic syndrome; Myopathy; Osteonecrosis; Respiratory disorder; Speech disorder; Abasia; Aspiration; Autoimmune disorder; Blood product transfusion; Death; Disability; Dysphagia; Guillain-Barre syndrome; Haemolytic anaemia; Intensive care; Neuropathy; Pneumonia bacterial; Respiratory disorder; Transfusion; Affect lability; Bronchitis; Dysphagia; Haemolytic anaemia; Hypokinesia; Immune system disorder; Myasthenic syndrome; Neuropathy; Osteonecrosis; Respiratory disorder; Thinking abnormal	FLU3~PFIZER\WYETH~7F81829~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~CONNAUGHT LABORATORIES~7F81829~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~7F81829~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Hospitalisation,Disabling	Influenza
0125285	07/01/1999	KY	41.0	41		M	06/25/1999	p/vax pt exp n/v, fever 103F, vertigo, migraine h/a & visual disturbances;pt stated eyes keep bugging out;pt unable to move legs for 60 days-a/ vax could walk w/ cane;pt hosp;psychiatry eval neg;pt remains incapacitated				Y	Y	10			N	11/01/1998	11/01/1998	0	eval by 4 neuro MDs;  EEG, EMG & CAT Scans, vestibulogram performed- no abnormalities detected;	UNK	UNK	ativanm valium, meclizine		hx: spinal cord injury (T8, T9-cord smashed) w/ active neurological sx;pt improved to using a walker before vax;post traumatic syringomyelia;		U199900438	1						1	Abdominal pain; Asthenia; Condition aggravated; Dizziness; Electroencephalogram abnormal; Eye disorder; Headache; Hypokinesia; Migraine; Personality disorder; Pyrexia; Somnolence; Vertigo; Visual disturbance; Vomiting	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0082176	07/06/1999	KS	63.0	63		M	06/14/1999	p/vax pt devel a fever of 103, & was hosp, up to 104, then down to 100.7; pt devel jaundice & an unspecified abscess, acute brain synd, kidney failure, resp distress, thrombocytopenia & hepatitis;pt died 3/22/96;no autopsy	Y	03/22/1996			Y				N	01/25/1996	02/01/1996	7	liver enzymes elev; COD determined to be multi organ failure;	PUB	UNK	unk	unk	unk		899168013A	1						4	Abscess; Delirium; Dyspnoea; Hepatic function abnormal; Hepatitis; Jaundice; Pyrexia; Renal failure; Thrombocytopenia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~4|MEN~CONNAUGHT LABORATORIES~5M71104~1~~~MENINGOCOCCAL (MENOMUNE)~4|OPV~PFIZER\WYETH~0736E~1~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~4|YF~CONNAUGHT LABORATORIES~5K61043~1~~~YELLOW FEVER (YF-VAX)~4	USA	Results in Death	Influenza
0125328	07/06/1999	GA	50.0	50		F	07/01/1999	severe soreness @ inj site w/in 1st 6-8hr;severe swelling lt upper arm, pain @ site w/in 48hr;unable to lift lt arm;swelling increased;w/in 1 wk could not lift lt arm, became frozen shoulder; now in P.T., still w/pain, prognosis fair								Y	N	10/09/1998	10/10/1998	1		PUB	PUB	Lopressor, Premarin	NONE	MVP	~ ()~~~In patient		1						1	Arthropathy; Hypokinesia; Injection site oedema; Injection site pain; Oedema peripheral	FLU3~PFIZER\WYETH~4988224~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0125635	07/13/1999	AK	50.0	50		F	06/24/1999	pt to hosp d/t severity of sx anxiety & agitation, heart palpitations, joint pain;				Y					N	09/23/1998	09/23/1998	0	unk	PUB	UNK		chronic pain	unk	~ ()~~~In patient		1						1	Agitation; Anxiety; Arthralgia; Palpitations; Agitation; Anxiety; Arthralgia; Palpitations	FLU3~MEDEVA PHARMA, LTD.~20118GA~2~IM A~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~201186A~2~IM A~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0106962	07/14/1999	OK	65.0	65		F	07/12/1999	p/pt recv vax the following day pt devel inject site redness, swelling & warmth extending to elbow as well as fever & malaise;									Y	10/27/1997	10/28/1997	1		PUB	PVT			unk	no relevant data~ ()~~~In patient	WAES97111614	1						3	Injection site hypersensitivity; Injection site oedema; Malaise; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~3|PPV~MERCK & CO. INC.~0845D~1~IM~LA~PNEUMO (PNEUMOVAX)~3	USA		Influenza
0106963	07/14/1999	OK	74.0	74		M	07/12/1999	p/recv vax the following day pt exp cellulitis to the elbow; fever & inject site warmth, & pain; given benadryl & antibiotics									Y	10/27/1997	10/28/1997	1		PVT	PVT			unk	no relevant data~ ()~~~In patient	WAES98060252	1						2	Cellulitis; Injection site hypersensitivity; Injection site pain; Pyrexia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0106967	07/14/1999	OK	58.0	58		F	07/12/1999	p/recv vax the following day pt exp redness & swelling at inject site to elbow; fever x2 days & rash on pt chest & neck; given benadryl									Y	10/27/1997	10/28/1997	1		PVT	PVT			unk	no relevant data~ ()~~~In patient	WAES98060251	1						2	Injection site hypersensitivity; Injection site oedema; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0106969	07/14/1999	OK	79.0	79		F	07/12/1999	p/recv vax pt exp slight soreness at inject site;									Y	10/27/1997	10/27/1997	0		PUB	PVT			unk	no relevant data~ ()~~~In patient	WAES98060275	1						2	Injection site hypersensitivity	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0106970	07/14/1999	OK	67.0	67		F	07/12/1999	the day p/recv vax pt exp redness, swelling & warmth at inject site									Y	10/27/1997	10/28/1997	1		PVT	PUB			unk	no relevant data~ ()~~~In patient	WAES98060269	1						2	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0106971	07/14/1999	OK	87.0	87		F	07/12/1999	p/recv vax pt exp slight soreness at inject site;									Y	10/27/1997	10/27/1997	0		PUB	PVT			unk	no relevant data~ ()~~~In patient	WAES98060274	1						2	Injection site pain	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0106972	07/14/1999	OK	66.0	66		F	07/12/1999	the day following vax pt exp redness & warmth at inject site; induration; malaise; pain & h/a;									Y	10/27/1997	10/28/1997	1		PUB	PVT			unk	no relevant data~ ()~~~In patient	WAES98060254	1						2	Headache; Injection site hypersensitivity; Injection site mass; Malaise; Pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0106973	07/14/1999	OK	76.0	76		M	07/12/1999	p/recv vax pt exp sore arm;									Y	10/27/1997	10/27/1997	0		PUB	PVT			unk	no relevant data~ ()~~~In patient	WAES98060272	1						2	Pain	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0106974	07/14/1999	OK	79.0	79		F	07/12/1999	the day following vax pt exp redness, swelling to elbow at inject site; inject site was hard & warm, malaise & pain;									Y	10/27/1997	10/28/1997	1		UNK	UNK			unk	no relevant data~ ()~~~In patient	WAES98060271	1						2	Injection site hypersensitivity; Injection site mass; Injection site oedema; Malaise; Pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0107000	07/14/1999	OK	74.0	74		M	07/12/1999	p/pt recv vax pt exp redness & swelling at the inject site; warmth at site & fever;									Y	10/27/1997	10/27/1997	0		PVT	PVT			unk	no relevant data~ ()~~~In patient	WAES98060253	1						2	Injection site hypersensitivity; Injection site oedema; Pyrexia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0117112	07/14/1999	CA	52.0	51		F	07/12/1999	p/vax pt exp inj site rxn consisting of redness, swelling, pain, & a heat sensation;also exp a fever of 100;pt sought unspecified medical attention;pt recovered from exp;				Y					Y	10/20/1998	10/20/1998	0	NONE	PUB	PUB			NONE	No Relevant Data~ ()~~~In patient	WAES98110433	1						2	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~1508E~2~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0118990	07/14/1999	WV	65.0	65		F	07/12/1999	p/vax pt exp mild runny nose & a very sore arm w/redness & bruised;10/12/98 also exp fever of >101, chills, h/a, neck pain, chest soreness & tachycardia;had extreme weakness & couldn't get out of bed for 36hr;pt recovered from exp;									Y	10/10/1998	10/10/1998	0		PUB	PVT			interstitial cystitis;nitrofurantoin allergy	No Relevant Data~ ()~~~In patient	WAES98101442	1						3	Injection site oedema; Injection site pain; Injection site oedema; Injection site pain; Pain; Pyrexia; Asthenia; Chest pain; Ecchymosis; Headache; Hypokinesia; Myalgia; Neck pain; Pyrexia; Rhinitis; Tachycardia; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~1~~~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~~1~A~~PNEUMO (PNU-IMUNE)~2|FLU3~CONNAUGHT LABORATORIES~0871H~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~~1~IM~LA~PNEUMO (PNEUMOVAX)~3	USA		Influenza
0118992	07/14/1999	NY	68.0	67		F	07/12/1999	p/vax pt exp site soreness, swelling & hardness;pt exp pain in lt arm around site of inj;pain radiated up & down & arm persisted for 4 - 5 days subsided then came back;pt having trouble raising arm, cant sleep that side;exp n, dx cellulitis									Y	11/05/1998	11/06/1998	1		OTH	OTH	Pepcid		unk	No Relevant Data~ ()~~~In patient	WAES98111194	1						3	Injection site oedema; Injection site pain; Nausea; Pain; Injection site oedema; Injection site pain; Nausea; Pain; Cellulitis; Hypokinesia; Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Insomnia; Nausea	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~1~IM~LA~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~~1~IM~LA~PNEUMO (PNU-IMUNE)~2|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~3	USA		Influenza
0124906	07/14/1999	IN	57.0	57		F	07/12/1999	day p/recv vax pt exp significant fever 101; also pt was feeling weak & shaky & exp h/a; took tylenol; 10/2 pt recovered;									Y	09/26/1998	09/27/1998	1		PVT	UNK	ecotrin; lotensin; glucotrol; apresoline; lorazepam; adalat; compazine		anxiety; diabetes mellitus; hypertension	no relevant  data~ ()~~~In patient	WAES98100091	1						2	Asthenia; Headache; Pain; Pyrexia; Tremor; Asthenia; Headache; Pyrexia; Tremor; Headache; Myalgia; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~20178HB~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~~1~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~~1~~~PNEUMO (PNEUMOVAX)~2|FLU3~MEDEVA PHARMA, LTD.~E20178HB~UNK~~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~3|PPV~UNKNOWN MANUFACTURER~1095H~UNK~~LL~PNEUMO (NO BRAND NAME)~3	USA		Influenza
0124927	07/14/1999	FL				M	07/12/1999	p/vax pt devel flu; also joint, hand, wrist, & knee discomfort; loss of energy; devel thrush; tx w/prednisone; lab tests:elevated erythrocyte sed rate; platelet count; & protein;pain in hips & arches on feet; sinus infect persisted;				Y					Y	10/01/1998	10/01/1998	0	12/15/99-1/7/99-elevated platelet count-433,0, erythrocyte-37&129, total serum protein-8.6;	UNK	UNK		external otic obstructions; sinusitis	sinusitis &  blocked ears	no relevant data~ ()~~~In patient	WAES99041032	1						2	Arthralgia; Asthenia; Influenza; Oral candidiasis; Pain; Arthralgia; Asthenia; Condition aggravated; Influenza; Laboratory test abnormal; Pain; Red blood cell sedimentation rate increased; Sinusitis; Thrombocythaemia	FLU3~MEDEVA PHARMA, LTD.~201584A~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0125851	07/14/1999	PA	73.0			M	07/12/1999	p/recv vax pt exp inj site swelling & applied ice; felt feverish & went to bed early; at time of rpt pt inj site swelling persisted;									N	10/05/1998				OTH	OTH				no relevant data~ ()~~~In patient	WAES98100378	1						1	Injection site oedema; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0125864	07/14/1999	MD	54.0	54		F	07/12/1999	p/recv vax pt exp wheaL 6'' long; inj site not affected, but medial; area swollen/red/sore; could not move arm; seen by acupuncturist & treated w/local acupuncture & bleeding methods to release heat; relieve pain/reduce swelling(disappeared				Y					Y	10/08/1998	10/10/1998	2		UNK	UNK	estrogenic preparations; nutritional supplements; DHEA; progesterone		multiple allergies	no relevant data~ ()~~~In patient	WAES98101143	1						1	Myalgia; Oedema peripheral; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0125872	07/14/1999	DE	60.0	60		F	07/12/1999	p/vax pt exp burning @ the inj site;p/pt presented w/an inj site rash up to neck, swelling, tenderness of the inj site;f/u info indicated that w/in 3 days of onset pt recovered;				Y					Y	10/14/1998	10/15/1998	1		OTH	OTH		bronchitis	unk	No Relevant Data~ ()~~~In patient	WAES98101449	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Lymphadenopathy; Rash	FLUX~UNKNOWN MANUFACTURER~~1~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0125874	07/14/1999	NJ	46.0	46		F	07/12/1999	p/vax pt exp inj site & rt arm pain, edema, rash immobility, warm to touch;pt arm was described as being taught;f/u from pt adverse exp resolved as of 10/20/98;									Y	10/16/1998	10/16/1998	0		PVT	PVT			hypothyroidism	No Relevant Data~ ()~~~In patient	WAES98101549	1						1	Hypokinesia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0125878	07/14/1999	NY	65.0	64		F	07/12/1999	p/vax pt exp pain & swelling in arm from the deltoid down to wrist;pt seen in MD office & it was noted that the redness & swelling had resolve, however,  pain persisted;pt recovered;				Y					Y	10/19/1998	10/20/1998	1		PVT	PVT	Ferrous sulfate;Inderal;Propylthiouracil;vitamin B12;Coumadin		atrial fibrillation;hyperthyroidism;	No Relevant Data~ ()~~~In patient	WAES98101722	1						1	Oedema peripheral; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0304H~1~SC~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0125879	07/14/1999	MA				F	07/12/1999	p/vax pt sought unspecified medical attention;				Y					U					UNK	UNK			unk	No Relevant Data~ ()~~~In patient	WAES98101732	1						1	Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0125891	07/14/1999	WV	38.0	38		F	07/12/1999	p/vax pt devel lt arm redness & swelling in a two to three inch area that was warm & painful to touch;pt also reported feeling blah;pt sx resolved in two days w/only sl redness @ the inj site;nurse reported pt recovered									Y	10/28/1998	10/30/1998	2		OTH	PVT			unk	No Relevant Data~ ()~~~In patient	WAES98110138	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Malaise	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0125892	07/14/1999	WA	51.0	51		F	07/12/1999	p/vax pt exp fever, chills, lt gluteal pain, redness & inflammation;MD reports 2 days post onset pt to MD who felt pt exp a localized rxn to pneumococcal vax;rx dicloxacillin x 10 days, ice on area 10-15min twice day & inc Relafen;				Y					Y	10/26/1998	10/28/1998	2		OTH	OTH	Prempro;Flonase;Lisinopril;Prilosec;		amoxicillin allergy;cephalosporin allergy;codeine allergy;erythromycin allergy;neomycin allergy;	No Relevant Data~ ()~~~In patient	WAES98110151	1						1	Injection site hypersensitivity; Injection site inflammation; Injection site pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~2~IM~GM~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0125894	07/14/1999	IL	66.0	66		M	07/12/1999	p/vax pt exp cellulitis;rt arm was swollen, red, & hot to touch;pt sought unspecified medical attention 7 was treated w/cephalexin;pt recovered from cellulitis;				Y					Y	10/05/1998	10/05/1998	0		PVT	OTH			unk	No Relevant Data~ ()~~~In patient	WAES98110183	1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0870H~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0125901	07/14/1999	CO	70.0	70		F	07/12/1999	p/vax pt exp a 4cm by 6cm warm, red rxn @ the rt side inj site that was raised approx 2mm;pt also c/o discomfort in the area;pt recovered;									Y	11/03/1998	11/04/1998	1		PUB	PUB			NONE	No Relevant Data~ ()~~~In patient	WAES98110432	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~5~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1508E~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0125920	07/14/1999	FL	36.0	36		F	07/12/1999	p/vax pt exp extreme soreness @ inj site w/red streaks & four dime-size red spots that came together as one large raised, red spot;pt also devel aches &T101.5;same day seen by MD dx inj site cellulitis;tx w/ATB & recovered;rxn not r/t vax				Y					Y	11/13/1998	11/13/1998	0		PUB	UNK			infectious agent exposure;sulfa allergy	No Relevant Data~ ()~~~In patient	WAES98111225	1						1	Cellulitis; Injection site hypersensitivity; Injection site pain; Myalgia; Pyrexia; Skin striae	FLU3~MEDEVA PHARMA, LTD.~~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1095H~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0125928	07/14/1999	TX	10.0	10		M	07/12/1999	p/vax pt exp soreness of the arm;pt also exp a high fever 103 in the evening, also hallucinatory dreams & delirium;got up & wandered the house w/the dreams & was diff to awaken;APAP given;pt exp mottled rash, t101, lethargic & n;									N	10/28/1998	10/28/1998	0		OTH	OTH			unk	No Relevant Data~ ()~~~In patient	WAES98111545	1						1	Abnormal dreams; Delirium; Hallucination; Hypersensitivity; Nausea; Pain; Pyrexia; Rash; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0125956	07/14/1999	TX	44.0	44		F	07/12/1999	p/vax pt exp SOB, pain under rt arm & across back, numbness in arms & fingers, back spasms & nausea;pt said it felt as if someone beat her;tx w/DPH & Toradol;pt recovered w/in 24hr;									Y	10/06/1998	10/07/1998	1	electrocardiogram-nl sinus rhythm;no acute change;exam negative;	UNK	UNK	Premarin		Medrol allergy; pred allergy	No Relevant Data~ ()~~~In patient	WAES98121563	1						1	Back pain; Dyspnoea; Hypertonia; Lymphadenopathy; Nausea; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1278E~1~~~PNEUMO (PNEUMOVAX)~1|TTOX~UNKNOWN MANUFACTURER~~1~~~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0126266	07/22/1999	MA	60.0	60		F	07/12/1999	p/vax pt felt like needle still in arm, lt arm pain, swelling, couldn't lift arm, not full range of motion. bruising of arm, slight fever off & on for 8 mon.									Y	10/14/1998	10/14/1998	0	arm XRAY, neg	PUB	PUB	premaim			~ ()~~~In patient	MA9910	1						1	Ecchymosis; Hypokinesia; Injection site pain; Oedema peripheral; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0975790~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0126433	07/29/1999	MA	65.0	65		F	07/21/1999	weakness, buzzing in head,faintness-dec in 1/2hr;next AM, strong neurological rxn in head, trunk & arm pain, difficulty breathing, head squeezed, ears clogged w/ringing;weakness & fatigue;flu like sx;faint, body pain, intestinal problems;				Y				Y	N	11/05/1998	11/05/1998	0		PUB	PUB	NONE	85lbs @ time, wasn't feeling well	recovery from mild pancreatitis, sensitive to chemicals, digestive disorder;	pt exp mild rxn to vax in past~ ()~~~In patient		1						1	Asthenia; Condition aggravated; Dizziness; Dyspnoea; Ear disorder; Gastrointestinal disorder; Headache; Influenza; Neuropathy; Pain; Tinnitus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0117490	08/05/1999	UT	72.0			M	03/10/1999	p/vax pt devel gritty rash on back & legs;seen MD & told to use caladryl lotion				Y					Y				unk	PUB	OTH	unk	unk	hypertension, 2 episodes of kidney stones 13-14 yrs of ago, quadruple coronary artery byposs grafting in 1987; elevated homocysteine levels	pt devel rash on ches & backt;flu shield-97-98 & 98-99~ ()~~~In patient	899158005L	1						2	Rash	FLU3~PFIZER\WYETH~~1~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0126932	08/05/1999	PA				U		p/recv flu vax & pt was dx w/ transverse myelitis; sx did not appear until spring. pt has extreme fatigue, feels nothing below the waist, gait significantly impaired; slight urine & bowel difficulties								Y	Y	11/18/1998	03/01/1999	103	8/99 MRI-fatty mass, angiolipoma in back; had surgery 8/7/99 to remove mass & is now recovered;	PVT	PVT	none	none	none	~ ()~~~In patient		1						1	Asthenia; Gait disturbance; Gastrointestinal disorder; Neoplasm; Paraesthesia; Urine analysis abnormal	FLU3~CONNAUGHT LABORATORIES~0966960~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0127368	08/05/1999	OK	28.0	28		F	02/04/1999	p/vax pt devel flushed face & an inj site react; mild redness & warmth; self-medicated w/benadryl									Y	11/13/1998	11/13/1998	0	unk	OTH	OTH	none	none	none	none~ ()~~~In patient	899132001L	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PFIZER\WYETH~4988228~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0127017	08/08/1999	MN	33.0	33		F	01/30/1999	5 days later devel vomiting, some loose stools required IV fluids on third day lasted for 6 days;				Y					Y	11/04/1998	11/09/1998	5		PVT	PVT		NONE	PCN, Cephlasporins	~ ()~~~In patient		1						1	Diarrhoea; Vomiting	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0127520	08/09/1999	NC	78.0	78		M	10/12/1994	p/vax pt exp pain which progressed to bilateral upper & lower weakness; seen by 3 MD; Dx: inflam arthritis was made;				Y					U	10/04/1994	10/05/1994	1		OTH	OTH	aspirin; multivitamin; lanoxin	none		~ ()~~~In patient	898287044A	1						1	Arthritis; Myasthenic syndrome; Pain	FLU3~PFIZER\WYETH~4948111~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0127521	08/09/1999	IL				F	06/17/1999	p/vax pt devel inj site redness; persisted for a long time									Y				unk	OTH	OTH	unk	unk	broke out during therapy w/bactrim in 1979	~ ()~~~In patient	899169050A	1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0127527	08/09/1999	FL	57.0	57		F	06/09/1999	A patient reported that she received an injection of FLU SHIELD (1995-96 formula) in 1996 and , subsequently developed a migratory rash which was itchy and oozed when scratched. She developed 2 infections as a result of scratching the rash. The patient has been taking prednisone since 1996 for the rash, and is currently being treated with ultraviolet light therapy which seems to be helping a bit. This patient was recently diagnosed with an allergy to thimerosal. The patient also reported this event to a local health regulatory agency (Ref. no. U1999-00347). She told the agency that she was immunized in the fall of 1995. She also told the agency that thimerosal allergy was diagnosed by skin bispsy and patch testing. she said she had a past history of hepatitis (type not specified). Altough she specifically told Wyeth-Ayerst that she had received no vaccines within 4 weeks of FLU SHIELD, she told the agency that she had received tetanus toxoid and pneumococcal vaccine within 4 weeks of FLU SHIELD.  Follow-up information received from a physician on 30-NOV-1999 indicated that patch testing resulted in a mild reaction to thimerosal. Skin biopsy performed on 04-MAY-1999 showed allergic contact dermatitis which could not be secondary thimersol given time frame. The patient has stasis dermatitis which improves when she is complaint with therapy. She also has intermittent eczema flares that are not related to thimerosal injection 3 years ago.				Y					U	01/01/1996	01/01/1996	0	Unknwon 05/04/1999, Biopsy NOS, allergic contact dermatitis; Skin test NOS positive, mild reaction to thimersol	PUB	PUB	PREMARIN, 0.9 daily; OSCAL, 1 tablet daily	NONE	Unknown		899161112A	1						1	Dermatitis bullous; Hypersensitivity; Infection; Pruritus; Rash	FLU3~PFIZER\WYETH~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0127053	08/10/1999	MA	72.0			F	08/04/1999	2wk p/vax, lt hand weakness, pt walking unsteadily, w/tendency to fall to lt side; drooled from lt angle of mouth; strength was MRC 4-/5 w/leg being 4+/5;pt strength deteriorated & arm became weak;biopsy confirmed dx glioblastoma;					Y				U	10/01/1997	10/01/1997	0	Brain magnetic resonance imaging  showed widespread areas of T2 hyperintensity in the rt temporal & parietal lobes;Babinski's sign present lt side;MRI suggest tumorStereotacti;brain biopsy confirmed dx of glioblastoma;	OTH	OTH			NONE		MPU199900265	1						1	Central nervous system neoplasm; Facial palsy; Gait disturbance; Hemiplegia; Myasthenic syndrome	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0127345	08/19/1999	DE	20.0	20		F	08/16/1999	p/vax pt exp vertigo; dizzy spells; seen by MD dx vertigo; MD stated common sx in local area(Hawaii); tx antivert; sx stopped p/2days; sx started again 1/99, dizzy; vertigo; ringing ears; dizzy spells; given meclizine;									N	10/13/1998	11/01/1998	19	to be accomplished	MIL	MIL	prilosac	GERD	slight murmur on lt	~ ()~~~In patient		1						1	Dizziness; Tinnitus; Vertigo	ANTH~MICHIGAN DEPT PUB HLTH~FAV043~3~UN~AR~ANTHRAX (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4988240~4~UN~AR~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0125635	08/23/1999	AK	50.0	50		F	06/24/1999	p/vax pt went to seattle due to severity of symptoms; anxiety & agitation; heart palpitations/joint pain				Y					N	09/23/1998	09/23/1998	0	unk	PUB	UNK		chronic pain	unk	~ ()~~~In patient	AK9911	1						2	Agitation; Anxiety; Arthralgia; Palpitations; Agitation; Anxiety; Arthralgia; Palpitations	FLU3~MEDEVA PHARMA, LTD.~20118GA~2~IM A~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~201186A~2~IM A~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0127561	08/24/1999	MA	57.0			F	05/19/1999	lit ref;p/vax pt devel rapidly progressive, symmetric, extremity weakness, facial diplegia, ophthalmoplegia, resp insufficiency & sensory ataxia; hosp;tests;dx:GBS;tx w/plasma exchange;sx worsened before stable;					Y				U				CSF-protein 168, glucose 146, RBC 3, WBC 2; IgM=365; IgM lambda-type monoclonal spike; electrodiagnostic studies: consistent w/GBS	OTH	OTH	unk	unk	non-insulin dependent diabetes mellitus		899142045A	1						1	CSF test abnormal; Coordination abnormal; Facial palsy; Guillain-Barre syndrome; Immunoglobulins increased; Laboratory test abnormal; Myasthenic syndrome; Neuropathy; Ophthalmoplegia; Respiratory disorder	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0117943	09/03/1999	WI	50.0	50		M	12/15/1998	p/vax pt exp malaise; flu-like symptoms/pre-syncope; no react @ either vax inj site; hosp &  tx: IV vancomycin & cefepime; disch p/3days; to complete augmentin therapy @ home			Y		Y	3			Y	12/09/1998	12/09/1998	0	blood cultures-pos for S. pneumoniae (typing not done); chest X-ray-no obvious infitrate or consolidation; there was a question of a lt lingular infitrate	PVT	OTH	beclomethasone inhaler; serevent inhaler;Albuterol inhaler;Glyburide;Vitamin B, C & E;	none	IgG multiple myeloma w/spinal lesions; status-post bone marrow transplant in 1995 & leukocyte infusion in 1996; non-insulin dependent DM;COPD;GERD;cervical disk disease secondary to mult myeloma;	unk~ ()~~~In patient	898350025A	1						2	Infection; Pneumonia; Pyrexia; Dizziness; Influenza; Laboratory test abnormal; Malaise; Sepsis	FLU3~PARKDALE PHARMACEUTICALS~02198P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~456690~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1|FLU3~CONNAUGHT LABORATORIES~02198P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~456690~UNK~IM~LA~PNEUMO (PNU-IMUNE)~2	USA	Life Threatening,Hospitalisation	Influenza
0118255	09/03/1999	MA	72.0	72		F	10/09/1998	p/vax pt began to exp mild numbness & tingling in lower extremities; mostly from mid-calf down; by May symptoms became more pronounced & pt was evaluated by MD & stated ``Idiopathic peripheral neuropathy''				Y					N	11/18/1997	03/01/1998	103	EMG & nerve conduction studies 9/3/98-results not provided	PVT	OTH	hydrochlorothiazide; lisinopril; ibuprofen	none	hypertension & osteoarthritis	none~ ()~~~In patient	898301001L	1						2	Neuropathy; Paraesthesia; Neuropathy peripheral; Paraesthesia	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0118965	09/03/1999	SC	24.0	24		F		p/vax pt devel an allerg rxn characterized by fever of 104, a lump & redness @ inj site, swelling in throat & swollen axillary lymph node;seen by MD tx pred, DPH & ice;exp chills, T101;numbness in fingers;pt recovered;				Y					Y	10/21/1998	10/22/1998	1	NONE	PUB	PVT	NONE	unk	fibromyalgia	NONE~ ()~~~In patient	898306052A	1						2	Injection site hypersensitivity; Injection site mass; Lymphadenopathy; Pyrexia; Hypersensitivity; Injection site hypersensitivity; Injection site mass; Laryngospasm; Lymphadenopathy; Paraesthesia; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454959~1~SC~LA~PNEUMO (PNU-IMUNE)~1|FLU3~CONNAUGHT LABORATORIES~967040~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~454959~1~SC~LA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0118983	09/03/1999	CA	34.0	34		F	12/01/1998	p/vax pt exp flu-like sx including sore throat, h/a & myalgia;									U	11/30/1998	11/30/1998	0		PVT	OTH	unk	unk	Influenza 2 wk prior to receiving immunization	~ ()~~~In patient	898351001L	1						2	Headache; Influenza; Myalgia; Pharyngitis; Headache; Influenza; Myalgia; Pharyngitis	FLU3~PFIZER\WYETH~~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~~LA~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~~UNK~~LA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0118985	09/03/1999	SC	48.0			M	10/28/1998	p/vax pt devel a fever ranging from 101.4 to101.9 & redness @ inj site;MD dx flu;									U	10/21/1998	10/23/1998	2		OTH	OTH	unk	unk		~ ()~~~In patient	898306053A	1						2	Infection; Injection site hypersensitivity; Pyrexia; Injection site hypersensitivity; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~454959~UNK~SC A~~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~454959~UNK~SC A~~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0118990	09/03/1999	WV	65.0	65		F	10/15/1998	p/vax pt devel a T101; & swelling & pain at site of inj; 10/12 inj site pain worsened & radiated to fingertips; resolving as of 10/15									U	10/10/1998	10/11/1998	1		OTH	OTH	augentin	interstitial cystitis		~ ()~~~In patient	898289097A	1						2	Injection site oedema; Injection site pain; Injection site oedema; Injection site pain; Pain; Pyrexia; Asthenia; Chest pain; Ecchymosis; Headache; Hypokinesia; Myalgia; Neck pain; Pyrexia; Rhinitis; Tachycardia; Vasodilatation	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~1~~~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~~1~A~~PNEUMO (PNU-IMUNE)~2|FLU3~CONNAUGHT LABORATORIES~0871H~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~~1~IM~LA~PNEUMO (PNEUMOVAX)~3	USA		Influenza
0118992	09/03/1999	NY	68.0	67		F	11/16/1998	p/vax pt exp pain in lt arm & nausea which persisted for five days;pt devel swelling & pain @ the site of pneumococcal vax;									U	11/05/1998	11/06/1998	1		PVT	PVT	Pepcid	NONE	Barrett's esophagus	~ ()~~~In patient	898322015A	1						2	Injection site oedema; Injection site pain; Nausea; Pain; Injection site oedema; Injection site pain; Nausea; Pain; Cellulitis; Hypokinesia; Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Insomnia; Nausea	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~1~IM~LA~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~~1~IM~LA~PNEUMO (PNU-IMUNE)~2|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~3	USA		Influenza
0121950	09/03/1999	OH	76.0	76		M	01/13/1999	p/vax pt exp pain in the periumbilical area & hard stool;CXR was performed & was nl;pt referred to a cardiologist;									U	12/11/1998			CXR-nl;	OTH	OTH	unk	unk	unk	unk~ ()~~~In patient	899014087A	1						2	Constipation; Pain; Abdominal pain; Constipation	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~~~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~~UNK~~~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0121954	09/03/1999	NY	67.0	67		F	01/29/1999	p/vax pt devel small area of redness at one of the inj site;the next day devel a 15 to 17cm area of warmth, swelling, pain & induration @ one of the sites & a fever 100.2 w/shaking chills;									Y	01/28/1999	01/28/1999	0	NONE	PVT	PVT	Lopressor;Diovan;Zocor;Premarin;Ecotrin;Vitamins;	NONE	HTN, hyperlipidemia & allergic to Ticlid & percocet;	unk~ ()~~~In patient	899033014A	1						2	Chills; Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Pyrexia; Tremor; Vasodilatation; Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Pyrexia; Tremor	FLU3~PFIZER\WYETH~4988234~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~454386~2~IM A~~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~4988234~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~454386~2~IM A~~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0127881	09/03/1999	IL	77.0	77		M	09/01/1999	GBS;			Y	Y	Y	120		Y	Y	10/07/1996	10/27/1996	20	MRI, CAT Scan, blood work-up	OTH	PUB	Ecotrin;Cardura;Lotrel;Kadur;	NONE	HTN, mild diabetes; cerebrovascular disease;benign prostatic hypertrophy	~ ()~~~In patient		1						1	Arthropathy; Guillain-Barre syndrome; Myelitis; Neuropathy	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0127943	09/03/1999	TX	70.0			M	09/24/1998	p/vax pt devel inj site rxn by inflam & pain										09/15/1998				PVT	PVT	unk	unk		~ ()~~~In patient	898271007A	1						1	Injection site inflammation; Injection site pain	FLU3~CONNAUGHT LABORATORIES~~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~449100~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0127945	09/03/1999	IN	49.0	49		F	10/01/1998	p/vax pt devel T104 which resolved p/24hr; oct 1,1998 had cough productive for white sputum & had chest congestion									Y	09/24/1998	09/25/1998	1	none	PVT	PVT	taxol; carboplatin	unk	large cell lung cancer; chemo ended 2 days prior to immun	unk~ ()~~~In patient	898275050A	1						1	Cough; Pyrexia; Respiratory disorder; Cough; Injection site pain; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E20178HB~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~454976~1~~RA~PNEUMO (PNU-IMUNE)~1|FLU3~MEDEVA PHARMA, LTD.~E20178HB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~PFIZER\WYETH~454976~UNK~IM~RA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0127947	09/03/1999	CA				U	09/30/1998	p/vax pt exp low back pain; flu symptoms; arm soreness & weakness									Y					OTH	OTH	unk	unk		~ ()~~~In patient	898280005L	1						1	Asthenia; Back pain; Influenza; Myalgia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454380~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0127948	09/03/1999	CA				U	09/30/1998	p/vax pt exp low back pain; flu symptoms; arm soreness & weakness									Y					OTH	OTH	unk	unk		~ ()~~~In patient	898280006L	1						1	Asthenia; Back pain; Influenza; Myalgia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454380~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0127949	09/03/1999	CA				U	09/30/1998	p/vax pt exp low back pain; flu symptoms; arm soreness; & weakness									Y					OTH	OTH	unk	unk		~ ()~~~In patient	898280007L	1						1	Asthenia; Back pain; Influenza; Myalgia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454380~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0127950	09/03/1999	CA				U	09/30/1998	p/vax pt exp low back pain; flu symptoms; arm soreness; and weakness;									Y					OTH	OTH	unk	unk		~ ()~~~In patient	898280008L	1						1	Asthenia; Back pain; Influenza; Myalgia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454380~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0127951	09/03/1999	CA				U	09/30/1998	p/vax pt exp low back pain; flu symptoms; arm soreness & weakness									Y					UNK	UNK				~ ()~~~In patient	898280009L	1						1	Asthenia; Back pain; Influenza; Myalgia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454380~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0127952	09/03/1999	IN	71.0	71		F	10/06/1998	p/vax pt devel swelling & pain at inj site;also devel fever; MD Dx cellulitis & rx biaxin									U	09/30/1998	10/01/1998	1		PVT	OTH	oscal; synthroid; lasix;coumadin;k-dur;imdur;atenolol;premarin;provera			~ ()~~~In patient	898281071A	1						1	Cellulitis; Injection site oedema; Injection site pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~448919~1~A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0127956	09/03/1999	AL				U	10/12/1998	p/vax pt devel cellulitis characterized by red; painful; swollen area at inj site; seen by MD & tx ATB				Y					U					PUB	PVT	unk	unk		~ ()~~~In patient	898287062A	1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0972840~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454979~UNK~A~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0127957	09/03/1999	AL				U	10/12/1998	p/vax pt devel inj site rxn characterized by red; painful; swollen area described as cellulitis;seen by MD; no tx				Y					Y					PUB	PVT	unk	unk		~ ()~~~In patient	898287063A	1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0972840~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454979~UNK~A~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0127958	09/03/1999	AL				U	10/12/1998	p/vax pt devel inj site rxn of red; painful; swollen area described as cellulitis									U					PUB	PVT	unk	unk		~ ()~~~In patient	898287064A	1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0972840~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454979~UNK~A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0127959	09/03/1999	AL				U	10/12/1998	p/vax pt devel inj site rxn of red; painful; swollen area described as cellulitis									U					PUB	PVT	unk	unk		~ ()~~~In patient	898287065A	1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0972840~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454979~UNK~A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0127960	09/03/1999	LA	77.0	77		F	10/12/1998	p/vax pt devel inj site rxn of redness & swelling;									Y	10/05/1998	10/05/1998	0		PVT	PVT	unk	none	controlled hypertension; hypercholesterolemia	~ ()~~~In patient	898287066A	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~MEDEVA PHARMA, LTD.~E20318LA~2~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~448518~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0127961	09/03/1999	TX	39.0	39		F	10/13/1998	p/vax pt devel T101.2; nasal congestion & inj site rxn of redness; swelling; warmth; pain & hives; tx: topical & oral DPH									Y	10/07/1998	10/08/1998	1	none	PVT	PVT	beclovent; nasalcrom; entex la; effexor; trazodone; buspar; axid; naprelan	none	perennial allergies; depression; GERD; osteoarthritis; asthma	pt had unspecified adverse event following inj of tetanus toxoid~ ()~~~In patient	898288006A	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia; Rhinitis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0968380~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~448192~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0127967	09/03/1999	SC				U	10/21/1998	p/vax pt devel inj site rxn of large lumps; redness; tenderness & warmth; resolved w/compresses									Y					PVT	OTH	unk	none	immunocompetent. last dose of Pnu-Imune-23 given in 1988	~ ()~~~In patient	898300079A	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~454979~UNK~SC A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0127968	09/03/1999	SC				U	10/21/1998	p/vax pt devel inj site rxn of large lumps; redness; tenderness & warmth; resolved w/using compresses									Y					PVT	OTH	unk	none	immunocompetent. last dose of Pnu-Imune-23 given in 1988	~ ()~~~In patient	898300080A	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~454979~UNK~SC A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0127969	09/03/1999	SC				U	10/21/1998	p/vax pt devel inj site rxn of large lumps; redness; tenderness & warmth; resolved w/using compresses									Y	10/21/1998				PVT	OTH	unk	none	immunocompetent. last dose Pnu-Imune-23 given 1988	~ ()~~~In patient	898300082A	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~454979~UNK~SC A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0127970	09/03/1999	SC				U	10/21/1998	p/vax pt devel inj site rxn of large lumps; redness; tenderness & warmth; resolved w/using compresses									Y					PVT	OTH	unk	none	immunocompetent; last dose of Pnu-Imune-23 given 1988	~ ()~~~In patient	898300083A	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~454979~UNK~SC A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0127971	09/03/1999	NE	75.0	75		M	10/22/1998	p/vax pt devel redness; edema & tenderness approx 1'' below the inj site; seen by MD				Y					Y	10/20/1998	10/20/1998	0		PVT	PVT	diovan; flonase inhaler; aspirin; diazepam	none	asthma, ASHD, MI; resuscitated sudden cardiac death w/implanted defibrillator insertion in 1994	~ ()~~~In patient	898300085A	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0984570~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454976~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0127972	09/03/1999	MN	88.0	88		F		p/recv vax on 10/9/98 pt inadvertently recv another inj on 10/22/98 of Pnu-Imune-23 & on 10/23 devel inj site rxn of redness 7 sl swelling									Y	10/22/1998	10/23/1998	1		OTH	OTH	unk	none		~ ()~~~In patient	898300087A	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~MEDEVA PHARMA, LTD.~E20178HB~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0127974	09/03/1999	KS	27.0	27		F	10/23/1998	p/vax pt devel inj site rxn of redness; warmth & pain; pt seen by MD; tx APAP				Y					Y	10/12/1998	10/13/1998	1		PUB	PUB	none		smoker	~ ()~~~In patient	898301089A	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~01998P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~454378~1~IM~LA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~7F91700~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0127975	09/03/1999	TN	77.0	77		M	10/26/1998	p/vax pt devel swelling & redness below left elbow; seen by MD noted not swelling or redness at inj site; MD does not believe pt exp a rxn				Y					U	10/20/1998	10/21/1998	1		PVT	PVT	cardizem	none		~ ()~~~In patient	898302017A	1						1	Oedema peripheral; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~523093~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0127978	09/03/1999	MO	77.0	77		F	10/28/1998	p/vax pt devel an inj site rxn characterized by pain, swelling, warmth & redness;pt recovered;									Y	10/27/1998	10/27/1998	0	unk	PVT	PVT	unk	NONE	COPD	unk~ ()~~~In patient	898306044A	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20188HD~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~455938~UNK~IM A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0127983	09/03/1999	AR	84.0	84		F	10/27/1998	p/vax pt reported pain @ inj site;pt was advised to be seen by MD but declined;pt recovered;									Y	10/16/1998	10/21/1998	5	NONE	OTH	PVT	K-dur;Insulin, diltiazem, Nitrostat, Lasix, coumadin, Propulsid;	NONE	Insulin-dependent diabetes mellitus, congestive heart failure, coronary artery disease, cardiac arrhythmia;allergic to PCN, IV dye, sulfa;	unk~ ()~~~In patient	898306049A	1						1	Injection site pain	FLU3~CONNAUGHT LABORATORIES~0975860~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~445636~UNK~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0127985	09/03/1999	SC				U	10/28/1998	p/vax pt devel redness @ the inj site;pt recovered;									Y	10/21/1998	10/23/1998	2		OTH	OTH	unk	unk		~ ()~~~In patient	898306051A	1						1	Injection site hypersensitivity	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~454959~UNK~SC A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0127992	09/03/1999	MI	36.0	36		F	10/30/1998	p/vax pt devel an inj site rxn characterized by erythema, warmth, tenderness & swelling which extended from rt shoulder to elbow & was hard as board;									Y	10/09/1998	10/10/1998	1	NONE	PVT	PVT	Wellbutrin SR;Flexeril;	NONE	fibromyalgia;	NONE~ ()~~~In patient	898307080A	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E20188HD~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~456690~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0127995	09/03/1999	MO				F	10/30/1998	p/vax pt devel a severe site rxn characterized by redness, warmth & pain;tx w/NSAIDS & oral ATB;									U	10/21/1998	10/23/1998	2		OTH	OTH	unk	unk		~ ()~~~In patient	898307086A	1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~454956~UNK~A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0127997	09/03/1999	KS	61.0	61		F	10/23/1998	p/vax pt devel fever 102, h/a, sleepiness & redness, swelling & pain @ site;pt recovered;				Y					Y	10/08/1998	10/13/1998	5	unk	PUB	PUB	unk	NONE	pt prev dose of vax given in 1993;	NONE~ ()~~~In patient	898308001L	1						1	Headache; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia; Somnolence; Headache; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia; Somnolence	FLU3~PARKDALE PHARMACEUTICALS~01998P~6~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~454378~2~IM~RA~PNEUMO (PNU-IMUNE)~1|FLU3~PARKDALE PHARMACEUTICALS~01998P~6~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~PFIZER\WYETH~454378~2~IM~RA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0127998	09/03/1999	KS	60.0			U	10/23/1998	p/vax pt devel redness @ the site of vax;									U					PUB	OTH	unk	unk		~ ()~~~In patient	898308002L	1						1	Injection site hypersensitivity	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~~UNK~IM A~~PNEUMO (PNU-IMUNE)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0128002	09/03/1999	CT	85.0	85		F	11/06/1998	p/vax pt devel inj site rxn @ pnu-imune 23 vax characterized by swelling, redness & warmth;									U	11/05/1998	11/06/1998	1		PVT	PVT	unk	NONE		~ ()~~~In patient	898314106A	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0966960~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~456690~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0128007	09/03/1999	MI				U	11/19/1998	p/vax pt devel inj site rxn @ site;rxn was described as cellulitis affecting the entire arm;									U					OTH	OTH	unk	unk		~ ()~~~In patient	898327050A	1						1	Cellulitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~456690~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0128008	09/03/1999	MI				U	11/19/1998	p/vax pt devel an inj site rxn described as cellulitis affecting the entire arm;									U					OTH	OTH	unk	unk		~ ()~~~In patient	898327051A	1						1	Cellulitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~456690~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0128018	09/03/1999	TX	66.0			F	09/24/1998	p/vax pt devel an inj site rxn characterized by inflammation & pain which lasted for several days;pt recovered;									Y	09/10/1998				PVT	PVT	unk	unk		~ ()~~~In patient	898344003L	1						1	Injection site inflammation; Injection site pain	FLU3~CONNAUGHT LABORATORIES~~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~449100~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0128024	09/03/1999	NJ	61.0	61		F	01/13/1999	p/vax pt exp an inj site rxn characterized by redness, swelling & pain;the site of vax & inj rxn were not specified;									U	10/15/1998	10/17/1998	2	unk	OTH	OTH	unk	unk	unk	unk~ ()~~~In patient	899014141A	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0975850~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~448175~UNK~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0128082	09/07/1999	WA	66.0	66		M	11/10/1997	p/vax pt had one episode of near syncope  & dizziness while driving; kind of like being sleepy;									Y	11/01/1997	11/03/1997	2	none	OTH	OTH	aznacort & breathair	none	s/p endarterectoney; emplysena; asthma/broncho spasm	~ ()~~~In patient	WA991582	1						1	Dizziness; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0128185	09/13/1999	NY	37.0	37		F	09/10/1999	p/vax pt could possible be preg, starting 10/4/98; pt devel flu; MD stated that pt had a spontaneous abortion									U	10/05/1998	12/01/1998	57		PVT	OTH			mitral valve prolapse (1978); urinary tract infect	~ ()~~~In patient	1998024794	1						1	Abortion	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~SMITHKLINE BEECHAM~~2~~~HEP A (HAVRIX)~1	USA		Influenza
0128329	09/17/1999	NJ	52.0	52		F	09/15/1999	pt exp burning sensation eyes;pt exp lower back pain;rt leg shaky & both legs hurting;took motrin;saw MD-poss pinched nerve;med given;could not stand or void;Dx transverse myelitis;disch w/cane & catheter;legs swollen; blood clot;Dx DVT				Y	Y			Y	N	10/14/1998	10/14/1998	0	Doppler ultrasound-DVT (deep vein thrombosis);10/20/99 lumbar puncture,brain scan,two MRI's	UNK	UNK			irritable bowel syndrome		U199900673	1						1	Back pain; Eye pain; Faecal incontinence; Hypokinesia; Myelitis; Neuralgia; Neuropathy; Oedema peripheral; Pain; Paraesthesia; Paralysis; Thrombosis; Tremor; Urinary incontinence; Urinary retention	FLU3~CONNAUGHT LABORATORIES~~6~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0125165	09/21/1999	TN	74.0	74		F	09/30/1999	could not swallow;large silent aspirations;could not walk;hosp; tx: plasma exchanges;IVIG;pred;PEG tube placement;blood transfusions;currently Dx:auto immune mediated motor neuron degeneration;new Dx:warm autoimmune hemolytic anemia			Y	Y	Y			Y	N	10/24/1997	11/01/1997	8	Numerous	UNK	UNK	coumadin, and numerous others	none	cardiomyopathy w/ CHF, chronic AFib w/ atrial thrombus, hypothyroidism, dyspepsia and intermittent GERD			1						3	Asthenia; Bone disorder; Dysphagia; Hypokinesia; Myasthenic syndrome; Myopathy; Osteonecrosis; Respiratory disorder; Speech disorder; Abasia; Aspiration; Autoimmune disorder; Blood product transfusion; Death; Disability; Dysphagia; Guillain-Barre syndrome; Haemolytic anaemia; Intensive care; Neuropathy; Pneumonia bacterial; Respiratory disorder; Transfusion; Affect lability; Bronchitis; Dysphagia; Haemolytic anaemia; Hypokinesia; Immune system disorder; Myasthenic syndrome; Neuropathy; Osteonecrosis; Respiratory disorder; Thinking abnormal	FLU3~PFIZER\WYETH~7F81829~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~CONNAUGHT LABORATORIES~7F81829~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~7F81829~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0128463	09/24/1999	HI	66.0	66		F	09/15/1999	p/vax pt swelling; redness; pain lt arm; weakness; diaphoresis; chills; feverish; 9/14 had erythema; tenderness;rt arm site of pneumovax was entirely asymptomatic									Y	09/11/1999	09/11/1999	0	none	PVT	PUB	dyazide;stnthroid	none	sulfa allerogy; HLSPI  t4 replacement	~ ()~~~In patient	HI9908	1						1	Asthenia; Hyperhidrosis; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia	FLU3~PFIZER\WYETH~U0982011~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1611H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0128484	09/27/1999	CA	71.0	71		F	09/21/1999	p/vax pt devel severe break-out w/red blisters all over body; (massive anaphylactic rxn); Steven Johnson syndrome				Y	Y				N	09/02/1999	09/13/1999	11	unknown	PVT	PVT				~ ()~~~In patient		1						1	Anaphylactoid reaction; Dermatitis bullous; Stevens-Johnson syndrome; Anaphylactoid reaction; Dermatitis bullous; Stevens-Johnson syndrome	FLU3~CONNAUGHT LABORATORIES~V0063AA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0063AA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0128585	09/27/1999	CA	63.0	63		M	09/21/1999	lt arm redness & itchy;tender;									Y	09/15/1999	09/16/1999	1	NONE	PVT	PVT		NONE		~ ()~~~In patient		1						1	Carditis; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0063AA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0128586	09/27/1999	CA	30.0	30		F	09/21/1999	lt arm pain & soreness, small amount of redness;									Y	09/01/1999	09/01/1999	0	NONE	PVT	PVT	NONE			~ ()~~~In patient		1						1	Myalgia; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~V0063AA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0128587	09/27/1999	CA	74.0	74		F	09/21/1999	rt arm red, raised & swollen @ site;4 inches long, 1 inch wide;									N	09/15/1999	09/15/1999	0	NONE	PVT	PVT				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~V0063AA~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0128684	09/28/1999	NY	65.0	65		F	09/23/1999	24hr post vax devel temp of 104 & SOB;dx: diffuse interstitial infiltrates, severe hypoxemia by arterial blood gas-pt underwent fiberoptic bronchoscopy w/transbronchial biopsy-revealed BOOP; rx high dose steroids				Y	Y	15			Y	09/08/1999	09/09/1999	1	bronchoscopy w/ transbrachial bx: BOOP- (Bronchiolitis obilterans w/organizing pneumonia);	PVT	PVT	Prevacid;Pred;Acecol, synthroid	ulcerative colitis	ulcerative colitis, hypothyroidism			1						1	Bronchiolitis; Dyspnoea; Hypoxia; Interstitial lung disease; Pneumonia; Pyrexia; Dyspnoea; Pneumonia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0064AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0064AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0128684	09/29/1999	NY	65.0	65		F	09/24/1999	p/vax pt devel T104 & exp SOB; hosp; chest x-ray showed infiltrates that were consistent w/pneumonia per BX culture					Y				Y	09/08/1999	09/09/1999	1	chest x-ray showed infiltrates that were consistant w/pneumonia per BX culture; culture results=BOOP-bronchiolitis obliterans organizing pneumonia	UNK	UNK					U199900695	1						2	Bronchiolitis; Dyspnoea; Hypoxia; Interstitial lung disease; Pneumonia; Pyrexia; Dyspnoea; Pneumonia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0064AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0064AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0128765	09/30/1999	NY	91.0	91		F	09/29/1999	p/vax pt acute non-ketotic ketoacidosis; blood sugar-800 in pt w/NIDDM controlled w/diet			Y	Y					N	09/21/1999	09/24/1999	3		PVT	OTH	none		Alzheimers, NIDDM; NKA			1						1	Acidosis; Condition aggravated; Hyperglycaemia; Myocardial infarction	FLU3~CONNAUGHT LABORATORIES~36415~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~6473900~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening	Influenza
0128771	09/30/1999	KS	38.0	38		F	09/24/1999	pt devel hives, rt arm swollen, hot, tender at vax site w/lymphadenopathy axilla;MD exam & rx for DPH & keflex;				Y					Y	09/22/1999	09/24/1999	2	NONE	PUB	UNK	Estorgen	NONE	NKA	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Lymphadenopathy; Urticaria	FLU3~PFIZER\WYETH~4998211~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~453069~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0128785	09/30/1999	IN	16.0	16		F	09/23/1999	w/in approx 2 wk began noticing purple spots approx 1cm on torso, arms, legs, feet turned purple @ times, especially when elevated;exp leg pain (muscular apparently) & listlessness;rash cont;									U	10/17/1995				PVT	PVT	Hep b vax by Engerix lot# 1742A2 given 9/19/95;	NONE	NONE	~ ()~~~In patient		1						1	Rash; Skin discolouration	FLU3~PARKE-DAVIS~01495P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~SMITHKLINE BEECHAM~180A2~2~IM~LA~HEP B (ENGERIX-B)~1	USA		Influenza
0128872	10/04/1999	AK	65.0	65		F	09/30/1999	local reaction-swollen, red & warm to touch;welt measuring 8cm;									Y	09/26/1999	09/27/1999	1	NONE	OTH	PVT	Prilosec;Prevana;synthroid;ogen;zestril	NONE	high BP, hypo thyroidism	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~7+~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0128883	10/04/1999	AK	31.0	31		F	09/27/1999	rt deltoid swollen w/erythema measuring 3 circumference;no other problems;									Y	09/20/1999	09/20/1999	0		PVT	OTH	special 1/1000 for allergies	NONE	allergic to animal dander, grasses, pollens;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4998209~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0128902	10/05/1999	TX	65.0	65		F	09/16/1999	pt dx w/GBS by MD;paralysis; partly recovered;				Y	Y	60	Y		N	10/15/1998	06/02/1999	230	spinal tap & nerve testing;	PUB	UNK	rx strength Ibuprophen as needed only	NONE	osteoarthritis	NONE~ ()~~~In patient	TX99184	1						1	Guillain-Barre syndrome; Paralysis	FLU3~CONNAUGHT LABORATORIES~0975790~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0128927	10/05/1999	MI	73.0	73		F	09/30/1999	red swollen arm rt upper red area is 5x6cm & edema is 15x16cm;				Y					U	09/29/1999	09/30/1999	1	NONE	PVT	UNK	Theodur;Lasix;Thryoid;arthritis	none x/COPD	COPD;arthritis	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4998236~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0128929	10/05/1999	TX	54.0	54		F	09/27/1999	cellulitis, redness, edema rt upper outer arm 6x8inches;red, hot & hard;pain in t arm pit lymph nodes;t103.5 on 9/25/99, would only decrease to 101.9-102 taking analgesics to cool baths;nausea w/dry heaves, swelling redness & heat resolved;				Y					Y	09/24/1999	09/24/1999	0	NA	PVT	PVT		NONE	allergic to cipro, PCN;hx of asthma, pneumonia, breast Ca, need chemo radiation;	~ ()~~~In patient		1						1	Cellulitis; Injection site hypersensitivity; Injection site mass; Injection site oedema; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0066BA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SMITHKLINE BEECHAM~2908A6~1~~RA~HEP B (ENGERIX-B)~1|PPV~PFIZER\WYETH~463731~2~~RA~PNEUMO (PNU-IMUNE)~1|TD~LEDERLE LABORATORIES~455382~7+~~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0128949	10/05/1999	AK	44.0	44		F	09/27/1999	p/vax pt arm rt arm swelled up, ached really bad, then 1 1/2 days later broke out w/severe rash;took DPH;arm sore;									U	09/18/1999	09/20/1999	2	NA	OTH	PVT	Synthroid, Valtrez, Naproxen	mild cold	PCN, strep, codeine coated pain meds, Graves disease;	~ ()~~~In patient		1						1	Injection site oedema; Injection site pain; Pharyngitis; Rash; Rhinitis	FLU3~PFIZER\WYETH~499822~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~UNKNOWN MANUFACTURER~459837~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0128961	10/06/1999	OH	33.0			F	10/05/1999	dizziness, SOB, itching;pt reported as reaction similar to prior allerg rxn;DPH & epi given;				Y					U	10/05/1999	10/05/1999	0		OTH	PVT		NONE	pt reports yellow dye	~ ()~~~In patient		1						1	Dizziness; Dyspnoea; Hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~499233~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0129135	10/08/1999	CA	40.0	40		F	10/06/1999	sx dizziness, nausea, blurred vision, h/a;cont to worsen throughout day;crushing chest pain, numbness, feelings of being very cold then passed out;amb called;upon arrival pt appeared pale & pulseless;CPR started;dx as Coronary Artery Spasm			Y		Y					10/05/1999	10/05/1999	0	levated troponin I; hypotension;	UNK	UNK	premarin;Prevacid;	anxiety				1						1	Amblyopia; Apnoea; Cardiac arrest; Cardiovascular disorder; Chest pain; Chills; Coronary artery disease; Dizziness; Headache; Nausea; Pallor; Paraesthesia; Syncope	FLU3~PARKDALE PHARMACEUTICALS~03179P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation	Influenza
0129157	10/08/1999	CA	45.0	45		F	10/04/1999	8:30PM devel redness on face, itchy throat & cough also swelling of lips;									Y	10/01/1999	10/01/1999	0		MIL	UNK	Lisinopirl, HCTZ, Prevacid	NONE	NONE	~ ()~~~In patient		1						1	Cough; Face oedema; Pharyngitis; Vasodilatation	FLU3~PFIZER\WYETH~4998211~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129169	10/12/1999	MA	45.0	45		F	10/08/1999	w/in a few minutes post vax pt exp burning sensation in back of throat;lips & face became numb, no SOB or wheezing;became dizzy, lightheaded;tach-110-120, BP 130/80, lost control of extremities;fell to floor-not passing out;pt adm to hosp;				Y	Y	2			Y	10/06/1999	10/06/1999	0	all labs WNL	PVT	PUB	Allegra	NONE	chronic sinusitis; sensitive to hair spray, pesticides, disinfectants			1						1	Coordination abnormal; Dizziness; Injury; Pain; Paraesthesia; Paraesthesia oral; Tachycardia	FLU3~CONNAUGHT LABORATORIES~U0107AA~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0129190	10/12/1999	NC	58.0	58		M	10/05/1999	c/o throat feeling tight w/choking sensation;no wheezing or SOB, no hives;MD notified pt to ER;MD does not feel it was rxn to flu shot;took DPH as area red;pt doing well;				Y					Y	10/05/1999	10/05/1999	0	pulse oximetry-nl;	PUB	UNK	ASA, alenolol;DPH	NONE	HTN, several TIA's	~ ()~~~In patient		1						1	Dysphagia; Laryngospasm	FLU3~PFIZER\WYETH~4998228~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0129197	10/12/1999	VA	78.0	77		F	10/06/1999	p/vax pt became very lightheaded;pt laid down & was given cold water;examined by NP;pt began having chest pain;EKG was OK but very weak;transferred to ER;				Y					Y	10/05/1999	10/05/1999	0	EKG & labs @ hosp ER	PVT	PVT	Zestril;Sinequan	HTN	HTN, hyperlipidemia, depression (roll-controlled)	~ ()~~~In patient		1						1	Chest pain; Dizziness; Laboratory test abnormal	FLU3~CONNAUGHT LABORATORIES~U0095AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0129199	10/12/1999	GA	40.0	40		F	10/06/1999	10/5/99 pain, swelling in lt arm, radiation down arm tremors in hands & thumb jerking, pressure feeling on lt wrist;				Y					Y	10/05/1999	10/05/1999	0	mild allergic reaction	PVT	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site oedema; Injection site pain; Muscle twitching; Pain; Tremor	FLU3~PARKDALE PHARMACEUTICALS~02979P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0129204	10/12/1999	FL	33.0	33		F	10/05/1999	pt began to scratch & itch in sleep;awoke to find that had hives;									Y	10/04/1999	10/05/1999	1	NONE	PVT	PVT	Preventil;Arobid inhalers	NONE	pet dander, dust mites	~ ()~~~In patient		1						1	Insomnia; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4998240~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129205	10/12/1999	MN	50.0	50		F	10/05/1999	chills, h/a, fatigue, nausea, achiness x 4 days;									N	10/01/1999	10/01/1999	0	NONE	PUB	PUB	ASA;Ibuprophen	NONE	PCN, Sulfa, SPine & neck problems;	~ ()~~~In patient		1						1	Asthenia; Chills; Headache; Myalgia; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0129206	10/12/1999	CA	62.0	62		F	10/06/1999	hard time breathing, tightness in chest using inhaler;bronchial tube congestion-dizzy, weak-difficulty concentrating;									N	10/06/1999	10/06/1999	0	NONE	PUB	PUB	DPH inhaler	NONE	asthma, pollen, animal dander, dust, mildew mold, smokes	~ ()~~~In patient	CA990112	1						1	Asthenia; Bronchitis; Chest pain; Dizziness; Dyspnoea; Thinking abnormal	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0129207	10/12/1999	CA	47.0	47		F	10/08/1999	p/vax pt began to exp pain lt deltoid which radiated over cap of shoulder & down into axillae;felt liked a fractured rib w/deep breathing-diff to breathe x 72hr;									Y	10/04/1999	10/04/1999	0	NONE	PVT	UNK	NONE	NONE	allergy sulfa	NONE~ ()~~~In patient		1						1	Dyspnoea; Injection site pain; Lymphadenopathy; Pain	FLU3~PFIZER\WYETH~U0096EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129208	10/12/1999	CA	35.0	35		M	10/08/1999	p/vax pt began to exp soreness & pain to lt flank & kidney area;no fever, no hematuria;no rx given;									Y	10/05/1999	10/05/1999	0	NONE	PVT	UNK	OTC-primatene	NONE	asthma	NONE~ ()~~~In patient		1						1	Pain; Renal pain	FLU3~CONNAUGHT LABORATORIES~U0096EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129219	10/12/1999	CA	39.0	39		F	09/29/1999	migraine h/a triggered by vax;pt exp pain in lt neck w/sensation of hearing & speech loud;typical muscle spasm;migraine poss triggered by flu vax but not causal;									Y	09/22/1999	09/28/1999	6	NONE	PVT	PVT	lmitrex, OC		migraine h/a 1-2 x 1mo	~ ()~~~In patient		1						1	Condition aggravated; Ear disorder; Hypertonia; Lymphadenopathy; Migraine; Speech disorder	FLU3~PFIZER\WYETH~499230~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129300	10/13/1999	CA	76.0	76		F	10/06/1999	14 x 16cm edematous area rt upper arm;				Y						10/05/1999	10/05/1999	0	NOONE	PVT	PVT		NONe	copd, CAD	NONE~ ()~~~In patient		1						1	Injection site oedema	FLU3~PFIZER\WYETH~4998211~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~463726~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0129310	10/13/1999	CA	82.0	82		F	10/05/1999	reported to hosp ER 10/4/99 in evening w/sx of vomiting, diarrhea & sl fever 98.2;MD did not confer allerg rxn to flu shot;suggested could be sl food poisoning;				Y					Y	10/04/1999	10/04/1999	0	EKG/CBC/Metabolic panel/glucose/amylase;	PUB	UNK	Diovan;Atenolol;Premarin;recent ATB use;Diuretic	NONE	hx GE reflux;diaphoretic, NKA;irregular pulse	~ ()~~~In patient		1						1	Diarrhoea; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~4998211~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0129311	10/13/1999	FL	65.0	65		F	10/08/1999	approx 2 1/2hr p/vax arm became red, swollen & painful;10/7/99 phoned hlth dept & advised to use hot/cold compresses (alternate) & OTC pain relief;pt to hlth dept 10/8/99 arm still swollen & painful;pt had cellulitis & bruising									U	10/06/1999	10/06/1999	0	NA	PUB	PVT	Zestril & combipatch	NA	NA	NA~ ()~~~In patient	FL99036	1						1	Cellulitis; Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~40996010~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0129312	10/13/1999	TX	59.0	59		M	10/13/1999	pt exp circumoral numbness & tingling to extremities the day p/vax;sx lasted for approx 4-6hr;no tx was sought by patient;									Y	10/05/1999	10/06/1999	1	NONE	OTH	OTH	NONE	NONE	polycystic kidney, chronic renal failure	~ ()~~~In patient		1						1	Paraesthesia; Paraesthesia oral	FLU3~PFIZER\WYETH~4998244~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129348	10/13/1999	CA	48.0	48		F	10/06/1999	approx 30min p/vax pt had hives upper chest, shoulders, face; no SOB;									Y	10/06/1999	10/06/1999	0	NONE	PVT	PVT	NONE	sinusitis-mild	allergic-sulfa	NONE~ ()~~~In patient		1						1	Urticaria	FLU3~PFIZER\WYETH~4998213~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0127997	10/14/1999	KS	61.0	61		F	09/28/1999	p/vax pt w/fever of 102, h/a, sleepiness, redness, swelling & pain @ site of Pnu-immune 23;pt recovered p/2 or 3 days;				Y					Y	10/08/1998	10/13/1998	5	unk	PUB	PUB	unk	NONE	prev dose of pnu-imune 23 was given in 1993;	NONE~ ()~~~In patient	FLU1020999	1						2	Headache; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia; Somnolence; Headache; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia; Somnolence	FLU3~PARKDALE PHARMACEUTICALS~01998P~6~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~454378~2~IM~RA~PNEUMO (PNU-IMUNE)~1|FLU3~PARKDALE PHARMACEUTICALS~01998P~6~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~PFIZER\WYETH~454378~2~IM~RA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0129352	10/14/1999	TN	27.0	27		F	10/11/1999	p/vax pt went to ER c/o rt arm red & swollen 5inches to 3.5inches rt deltoid;pt cont to be swollen p/vax;ER report VS pulse 98, BP 143/85, T97;arm cont swollen p/vax over 72hr;				Y					N	10/08/1999	10/08/1999	0		PVT	PVT	Birth Control Pills	NONe	allergic to codeine	~ ()~~~In patient		1						1	Hypertension; Hypothermia; Injection site hypersensitivity; Injection site oedema; Tachycardia	FLU3~PARKDALE PHARMACEUTICALS~03279P~1~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~~1~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0129354	10/14/1999	PA	84.0	84		M	10/08/1999	pt taken to hosp ER p/suffering from swelling of lt arm which extended to lt hand & fingers;pt had as a result of the swelling limited mobility of extremity;area was sl reddened warm upon extremities & swelling was subsiding;dx lymphedema;				Y					Y	10/05/1999	10/05/1999	0	physical exam;	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	PA9967	1						1	Hypokinesia; Injection site hypersensitivity; Injection site oedema; Lymphadenopathy; Oedema peripheral; Vasodilatation	FLU3~PFIZER\WYETH~4998212~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1716H~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0129364	10/14/1999	DC	52.0	51		F	10/07/1999	redness, swelling, discomfort @ inj site radiating to elbow-wrist area;ice, DPH, Ibuprophen;									Y	10/06/1999	10/06/1999	0	NA	OTH	PVT	clonidine	NONE	menopause	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0067AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129365	10/15/1999	MD	35.0	35		F	10/14/1999	pt reported pain @ rt deltoid w/swelling, dec mobility extending to fingers & scapula, pruritus surrounding inj site & ant chest, lungs in throat;transported by amb to hosp & tx w/epi & ice compresses;dx anaphylaxis;				Y	Y				N	10/12/1999	10/12/1999	0		PVT	PVT	Proventil inhaler PRN;Pravachol;Wellbutrin;Mircette;	asthma-controlled;	hemangioma;borderline hyperlipidemia;migraine h/a;irritable synd;depression			1						1	Anaphylactoid reaction; Hypokinesia; Injection site oedema; Injection site pain; Laryngospasm; Pruritus; Dyspnoea; Oedema peripheral; Pain; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4998265~3~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1692H~2~IM~~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~~2~~~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0129369	10/15/1999	NY	26.0			M	10/15/1999	p/vax pt slumped over & fell on floor;loss consciousness 5 sec;awoke c/o h/a;hit head on floor;vitals BP 130/70, P80 regular;vasovagal rxn dx;				Y					Y					PVT	PVT			NKDA			1						1	Headache; Hypertension; Hypoventilation; Syncope	FLU3~CONNAUGHT LABORATORIES~0063AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SMITHKLINE BEECHAM~9297A~UNK~IM~LA~HEP B (ENGERIX-B)~1|HEPA~SMITHKLINE BEECHAM~547A1~UNK~IM~RA~HEP A (HAVRIX)~1|IPV~CONNAUGHT LTD.~P0824~UNK~SC~RA~POLIO VIRUS, INACT. (POLIOVAX)~1|MEN~CONNAUGHT LABORATORIES~6734AA~UNK~SC~LA~MENINGOCOCCAL (MENOMUNE)~1|TD~CONNAUGHT LABORATORIES~V0011AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1|TYP~CONNAUGHT LABORATORIES~P1426~UNK~IM~LL~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|YF~CONNAUGHT LABORATORIES~VA015AA~UNK~SC~RA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0129371	10/15/1999	IN	20.0	20		F	10/11/1999	p/vax pt began to itch on chest & back by 10:20AM entire trunk of body covered w/red circular welts;tx in ER w/DPH;				Y					Y	10/07/1999	10/07/1999	0	NONE	PVT	OTH	Orthotricyline BC pills	NONE	NONE	NONE~ ()~~~In patient		1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0126FA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1286H~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0129372	10/15/1999	TN	28.0	28		F	10/14/1999	cellulitis of rt arm, approx 20cm x 10cm around inj site;severe itching/head from erythematous area;pt noticed first signs of itching w/small area of redness/rash;allergic rxn;				Y					U	10/07/1999	10/07/1999	0		PVT	UNK		sinusitis	PCN, Keflex, codeine	~ ()~~~In patient		1						1	Cellulitis; Hypersensitivity; Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~4998224~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1692H~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0129376	10/15/1999	NY	65.0	65		F	10/08/1999	p/vax pt arm was sl uncomfortable, swelling grapefruit sized from shoulder to almost elbow & redness;pt upper arm was sl swollen w/redness;half dollar sized area @ inj site & was hardened & warm to touch;									Y	10/05/1999	10/06/1999	1		UNK	PUB	Tamoxifen	NA	hx of breast cancer	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~01889P~2~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~461144~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0129378	10/15/1999	KY	64.0	63		F	10/12/1999	10/9/99 awoke w/tightness in chest & wheezing;no fever;10/10/99 wheezing-chest tightness-dizziness;10/11/99 wheezing better-dizziness;10/12/99 felt well did not see MD;									Y	10/08/1999	10/09/1999	1	NONE	PUB	PUB	NONE	NONE	iodine/cartesone/hx of bronchitis	~ ()~~~In patient	KY990042	1						1	Asthma; Chest pain; Dizziness	FLU3~PARKDALE PHARMACEUTICALS~02979P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0129379	10/15/1999	IL	33.0	33		F	10/15/1999	approx x 2' red area of lt arm;itchy, sore & feels warm;										10/13/1999	10/14/1999	1		OTH	PVT	BP	NONE	HTN	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0150AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129382	10/15/1999	TN	28.0	28		M		cellulitis of lt arm, approx 5cm x 15cm, around inj site;heat from erythematous area;+ fever;+ malaise;pt felt tired x 2hr p/vax;rash noticeable about 8hr p/inj;allerg rxn;									Y	10/12/1999	10/12/1999	0	CBC pending;	PVT	UNK		hyperlipidemia		~ ()~~~In patient		1						1	Asthenia; Cellulitis; Hypersensitivity; Injection site hypersensitivity; Malaise; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4992224~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1692H~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0129383	10/15/1999	MA	65.0	64		F		probably none, 24hr p/vax pt devel paralysis probably unrelated;									N	10/06/1999				UNK	UNK	multiple		polio as child, GERD, dec thyroid;			1						1	Paralysis; Colitis; Diarrhoea; Dry mouth; Gastritis; Guillain-Barre syndrome; Hypertension; Hypothyroidism; Myasthenic syndrome; Paralysis	FLU3~SANOFI PASTEUR~U0107AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0107AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0129384	10/15/1999	MI	51.0	51		F	10/14/1999	p/vax pt exp croupy cough w/o stridor, no wheeze;c/o chest tightness, air hunger was conscious of breathing, felt like could not fully expand chest & felt hot then cold;									Y	10/13/1999	10/13/1999	0	NONE	PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Chest pain; Chills; Cough; Dyspnoea; Laryngitis; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~4099G010~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0129387	10/15/1999	CA	74.0	74		M	10/07/1999	marked erythema & induration w/inc heat & pain @ site which started evening p/vax w/good response to Cox Z inhibitor; much improved w/dec pain in 24hr;									Y	09/29/1999	09/30/1999	1	NONE	PVT	PVT	Coumadin;Lasix, Digoxin;Accupril;Tenormin	NONE	cardiomyopathy, CAD, s/p MVR, recurrent  DVTO, DJD	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~~7+~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~458746~7+~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0129388	10/15/1999	CA	19.0	19		M	10/08/1999	p/vax inj site became red & extremely tender, warm to touch, redness extended to lt elbow x lt torso;tx w/Ibuprofen w/effect;									Y	10/06/1999	10/07/1999	1	NONE	PVT	UNK		NONE	congenital adrenal hyperplasia/asplenia	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4998284~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~458746~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0129394	10/15/1999	NJ	50.0	50		F	09/27/1999	on 3rd day p/vax pt devel rash on both legs-papular w/white border-not itchy lasted 3 days;									Y	09/23/1999	09/26/1999	3		PVT	PVT	Amoxicillin	NONE	NONE	~ ()~~~In patient		1						1	Rash maculo-papular	FLU3~PFIZER\WYETH~4998237~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129395	10/15/1999	MD	97.0	97		F	10/11/1999	rt deltoid area became red & inflamed approx size of a baseball, increased warmth, no tenderness;tx w//cold compress on 10/11/99 area w/o redness or warmth remains swollen;									Y	10/06/1999	10/09/1999	3	NONE	OTH	OTH	Iron, vitamin, Coumadin, paxil, Prevacid, Demadex	NONE	allergy: ASA, PCN, Sulfa	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site inflammation; Injection site mass; Vasodilatation	FLU3~PFIZER\WYETH~4998212~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129397	10/15/1999	MI	70.0	69		M	10/07/1999	p/vax pt exp tightening in chest & throat, like an asthma attack then devel fever & severe body aches lasted 24hr;states exp similar sx p/flu shot last year;had flu shot for years a/w/o problem;									Y	10/01/1999	10/01/1999	0	NONE	UNK	UNK	HCTZ;Plendil	NONE	high BP;hx of mild asthma-?cause			1						1	Asthma; Chest pain; Condition aggravated; Laryngospasm; Myalgia; Pyrexia; Vaccine positive rechallenge	FLU3~PARKDALE PHARMACEUTICALS~4099G010~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0128484	10/18/1999	CA	71.0	71		F	10/12/1999	p/vax pt presented w/severe breakout of red blisters all over body  & Stevens Johnson Synd attributed to a massive anaphylactic rxn;				Y	Y				N	09/02/1999	09/13/1999	11	unk	PVT	PVT				~ ()~~~In patient	U199900728	1						2	Anaphylactoid reaction; Dermatitis bullous; Stevens-Johnson syndrome; Anaphylactoid reaction; Dermatitis bullous; Stevens-Johnson syndrome	FLU3~CONNAUGHT LABORATORIES~V0063AA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0063AA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0129295	10/18/1999	CA	40.0	40		F	10/07/1999	sudden onset of n/v & moderate h/a 30min p/vax;pt seen 2hr p/vax;pt was entirely well prior to vax;				Y						10/07/1999	10/07/1999	0	WBC-15000;UA negative;	OTH	PUB	NONE	NONE	NKA;hx h/a ? migraine	NONE~ ()~~~In patient		1						1	Headache; Leukocytosis; Vomiting	FLU3~PARKDALE PHARMACEUTICALS~01889P~3~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0129440	10/18/1999	SC	36.0	36		F	10/13/1999	p/vax pt devel tightness in chest & flushing;pt given DPH in MD office & recovered;this event is considered medically significant;									Y	10/13/1998	10/13/1998	0	unk	OTH	OTH	unk	unk	unk		1510106OCT199	1						1	Chest pain; Vasodilatation	FLU3~PFIZER\WYETH~~3~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129453	10/18/1999	MA	40.0	40		M	11/05/1999	p/vax pt reported feelings of facial hemiparesis that progressed over the next 24hr;tx for a foreign body irritation in rt eye & w/pred for a dx of Bell's Palsy;pt had a dec in eye pain & some improvement in rt side facial paresis; It was reported, A member of the Air Force Reserves, as part of his duty requirement, was given influenza vaccination on 04 October 1984. The following day, he reported feelings of facial hemiparesis that progressed over the next 24 hours. He was treated for a foreign body irritation in his right eye and with Prednisone for a diagnosis of Bell's Palsy. As of 17 October 1998, he had a decrease in eye pain and some improvement in right-sided facial paresis, which was still obvious.				Y					Y	10/04/1998	10/05/1998	1		MIL	MIL		None	None		U199800923	1						1	Eye irritation; Eye pain; Facial palsy; Facial paresis; Foreign body in eye; Hemiparesis; Facial palsy; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0970170~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0129453	10/18/1999	MA	40.0	40		M	11/24/1998	p/vax pt exp numb feeling on rt side of face;same afternoon noted asymmetry of facial movements;pt reported to ER where dx w/Bells Palsy;given pred;				Y					Y	10/04/1998	10/05/1998	1	NONE	MIL	MIL	NONE	NONE	NONE	pt exp rxn @ age 25yr w/influenza~ ()~~~In patient		1						2	Eye irritation; Eye pain; Facial palsy; Facial paresis; Foreign body in eye; Hemiparesis; Facial palsy; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0970170~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0129461	10/18/1999	HI				U		dizziness, n/v, pain epigastric area 1 day post vax;to ER;				Y					Y	09/05/1999	09/06/1999	1		PUB	PVT		NONE	NONE	~ ()~~~In patient		1						1	Abdominal pain; Dizziness; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0064AA~3~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0129468	10/18/1999	KS	39.0	39		F	10/15/1999	10min p/vax pt exp chest tightness & SOB;wheezing occurred;p/albuterol nebulizer tx w/o improvement;to ER w/inc wheezing & SOB;given epi, DPH, Tagamet & micronephrine nebulizer tx w/slow improvement;3.5x4cm reddened area @ inj site;				Y					Y	10/14/1999	10/14/1999	0	NONE	PUB	PVT	Celebrex;Accolate;Bumex;Proventil inhaler;Asthmacort Inhaler;	hx of asthma-no symptoms @ time of vax;	Keflex, Vancomycin, codeine & related drugs, tetracycline, OTC vitamins, Theodur	pt exp inj site redness @ age 38 w/flu vax;~ ()~~~In patient		1						1	Asthma; Chest pain; Dyspnoea; Injection site hypersensitivity; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0104AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0129472	10/18/1999	OR	73.0	73		F	10/14/1999	c/o lt elbow pain x 1 days p/vax in lt deltoid;unable to fully straighten elbow;able to fully flex;no swelling, no erythema, no tenderness;				Y					N	10/08/1999	10/09/1999	1	lt elbow x-ray-negative x/for questionable mild effusion;	PVT	PVT	Premarin;Provera;Doxepin;ASA;CA, Vit C	NA	postmenopausal synd;no drug allergies	NA~ ()~~~In patient		1						1	Arthralgia; Osteoarthritis	FLU3~PFIZER\WYETH~4998210~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0129473	10/18/1999	OR	84.0	84		M	10/14/1999	c/o lt shoulder pain that spread to lt elbow on the evening p/the vax;presented to the office next AM w/ c/o swelling & tenderness & inability to move elbow fully;tx w/decadron, DPH, APAP & ice;				Y					N	10/13/1999	10/13/1999	0	NA	PVT	PVT	ASA;Mavik;Prilosec;Norvasc;Allegra	NA	allergic rhinitis, HTn, PUD, rt knee OA, allergic to naprosyn	NA~ ()~~~In patient		1						1	Arthralgia; Oedema peripheral; Pain	FLU3~PFIZER\WYETH~4998210~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0129475	10/18/1999	TX	75.0	75		F	10/12/1999	10/8/99 tingly feeling arms & legs-severe h/a 3PM took fiorinal;10/9/99 tingly feeling cont some aching between shoulders & neck;10/10/99 hurting across shoulders & back & neck, wrists & ankles;tingly feeling cont;weak;vomited;queasiness;				Y					Y	10/08/1999	10/08/1999	0	NONe	PUB	PUB	Niacin;toprol XL;HCTZ;Oravail;Ecotrin;	NONE	inc cholesterol, inc BP, angina;	pt exp pneumonia p/flu vax in 1950;s;~ ()~~~In patient		1						1	Arthralgia; Asthenia; Dyspepsia; Headache; Myalgia; Pain; Paraesthesia; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0130AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0129476	10/18/1999	VA	59.0	59		F	10/13/1999	pt devel hives approx 4hr p/vax which occurred intermittently through that noc & next day;took DPH & had no further hives;also had sore throat & was achy for 2 days;									Y	10/06/1999	10/06/1999	0	NA	PUB	PUB	Premarin;Progestrone;Prilosec;	NA	NONE	NA~ ()~~~In patient	VA99052	1						1	Myalgia; Pharyngitis; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~02979P~7+~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0129477	10/18/1999	PA	78.0	78		M	10/13/1999	p/vax pt exp wheezing;									Y	10/11/1999	10/12/1999	1		UNK	UNK		mild ST in AM a/shot given		~ ()~~~In patient		1						1	Asthma	FLU3~CONNAUGHT LABORATORIES~U0128BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129478	10/18/1999	TX	53.0	53		F	10/15/1999	onset of rashes noted on both cheeks & neck;feels hot;no resp problems;no itching;given DPH;P80;RR 22;									Y	10/15/1999	10/15/1999	0		OTH	PVT	nasal spray;	sinus congestion	pt mom allergic to eggs;	~ ()~~~In patient		1						1	Hyperventilation; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4998280~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129479	10/18/1999	UT	1.1	1	.1	F	10/04/1999	p/vax pt fainted revived immed;given 02/mask & juice;									Y	10/04/1999	10/04/1999	0		PUB	PUB		NONE		~ ()~~~In patient	UT992728	1						1	Hypoxia; Syncope	FLU3~PARKDALE PHARMACEUTICALS~4099G010~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0129482	10/18/1999	MT	75.0	75		M	10/08/1999	p/vax pt upper arm started aching & swelling which then proceeded down the arm into the hand;the arm was warm to touch;it stayed swollen all day;									Y	10/01/1999	10/01/1999	0	NONE	PVT	PVT	Coumadin;Paxil;Zestoretic	s/p CVA;bronchitis	NONE	NONE~ ()~~~In patient		1						1	Myalgia; Oedema peripheral; Vasodilatation	FLU3~PFIZER\WYETH~4998259~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~455757~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0129493	10/18/1999	MS	72.0	72		M	10/12/1999	tightness in chest;h/a base of skull >3-5min p/inj;no rx required;									Y	10/12/1999	10/12/1999	0		PUB	UNK			multiple	~ ()~~~In patient	MS99041	1						1	Chest pain; Headache	FLU3~PFIZER\WYETH~4998232~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~459560~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0129495	10/18/1999	CA	4.0	4		M	10/05/1999	red raised rash on chest-x2 days;did not seek treatment;									Y	10/05/1999	10/05/1999	0	NONE	PUB	PUB	Amoxicillin-has been on it for a tooth abscess for 10 days	NONE	myotonic dystrophy	NONE~ ()~~~In patient	CA990108	1						1	Rash maculo-papular	FLU3~PFIZER\WYETH~4998216~3~~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129498	10/18/1999	TX	30.0	30		F	10/14/1999	redness & swelling @ site of inj;									Y	10/13/1999	10/13/1999	0	NA	PVT	PVT	NA	NA	PCN	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PARKDALE PHARMACEUTICALS~4099G010~3~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0129499	10/18/1999	TX	50.0	50		F	10/14/1999	redness-swelling in area where flu vax was given;achy feeling;									Y	10/12/1999	10/14/1999	2	NA	PVT	PVT	Depo Provera	NONE	allergies PCN	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Myalgia	FLU3~PFIZER\WYETH~4998233~7+~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129500	10/18/1999	TX	26.0	26		F	10/14/1999	pt got nauseated x 8hr;inj site got hard;no redness noted;									Y	10/13/1999	10/13/1999	0	NA	PVT	PVT	NA	NONE	amoxycillin	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Nausea	FLU3~PARKDALE PHARMACEUTICALS~4099G010~4~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0129383	10/19/1999	MA	64.0	64		F	10/13/1999	completely paralyzed below the neck;weakness is cont up through face;dry mouth;some diarrhea-irritable bowel.Dxed w/ Guillain-Barre Syndrome variant,gastritis,hypertension,& hypothyroidism.				Y	Y				N	10/06/1999	10/07/1999	1		PVT	PUB	Psychiatric medications			~ ()~~~In patient		1						2	Paralysis; Colitis; Diarrhoea; Dry mouth; Gastritis; Guillain-Barre syndrome; Hypertension; Hypothyroidism; Myasthenic syndrome; Paralysis	FLU3~SANOFI PASTEUR~U0107AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0107AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0129521	10/19/1999	WA	21.0	21		M	10/07/1999	swelling, stiffness, pain in rt arm above aid below the elbow x 1 day;				Y					Y	10/05/1999	10/06/1999	1		UNK	UNK						1						1	Hypertonia; Injection site oedema; Injection site pain; Oedema peripheral; Pain	ANTH~MICHIGAN DEPT PUB HLTH~FAV024~6~SC~RA~ANTHRAX (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4998345~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0129536	10/19/1999	FL	66.0	66		F	10/05/1999	pt c/o redness & swelling to lt upper & mid arm-beginning the evening p/vax;c/o severe pain & restricted movement of same limb;states had fever on 10/1/99 PM;called pvt MD on 10/1/99 & was seen by MD on 10/2/99 & tx w/pred & ATB;				Y					Y	10/01/1999	10/01/1999	0	NONE	PUB	OTH	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Hypokinesia; Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Pain; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E242596A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1095H~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0129541	10/19/1999	CA	29.0	29		M	10/10/1999	about 5min p/vax pt was sitting in chair w/eyes rolling back & upper & lower extremities twitching, pale-911 called sx lasted about 30-60seconds;BP 70/50, AP 76 irreg, resp 16;BP 110/60;									Y	10/10/1999	10/10/1999	0		OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Gaze palsy; Hypotension; Hypoventilation; Muscle twitching; Pallor	FLU3~PFIZER\WYETH~4998242~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129547	10/19/1999	HI	81.0	81		M	10/12/1999	itching, hives, coughing;DPH given;rxn lasted approx 2-2 1/2hr;									Y	10/01/1999	10/02/1999	1	NA	PVT	OTH	HMO	had flu 2wk prior	NONE	NA~ ()~~~In patient		1						1	Cough; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0129549	10/19/1999	IL	53.0	53		F	10/15/1999	red bumpy dots, ovals w/yellow centers that itchy back, chest, arms, legs & buttocks since 9/23/99;pt still has rash;									N	09/22/1999	09/23/1999	1	NONE	PUB	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Dermatitis bullous; Rash; Pain; Pruritus; Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0129550	10/19/1999	MI	58.0	58		F	10/15/1999	p/vax pt devel welt @ site, size of quarter;then pt devel a red 2 x 1-warm & hard lump;									Y	10/11/1999	10/11/1999	0	NONe	PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0129553	10/19/1999	OH	57.0	56		M	10/13/1999	p/vax pt lower lip began to swell & turn outward;also c/o numbness & tightness around mouth;had minimal swelling the next morning;									Y	10/04/1999	10/04/1999	0	NA	OTH	OTH	Zestoretic	NA	HTN, NKDA	NA~ ()~~~In patient		1						1	Face oedema; Paraesthesia oral	FLU3~CONNAUGHT LABORATORIES~U0118AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129554	10/19/1999	IN	64.0	64		F	10/13/1999	p/vax pt had large orange size swelling 3inches below inj site on rt upper arm;painful to touch & hot;used ice pack;swelling was down but red area kept moving down;									Y	10/12/1999	10/12/1999	0		UNK	UNK	Premarin;Provera;Zyrtec;Accolate	NONE	allergies & asthma	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0129557	10/19/1999	MI	49.0	49		F	10/12/1999	p/vax pt devel sl soreness @ 12:30;10/10/99 redness in evening & warm;hard lump size of plum;sx peaked @ 4AM 10/11/99;									Y	10/10/1999	10/10/1999	0		PUB	PVT	NONE	NONE	NONE	unk~ ()~~~In patient		1						1	Myalgia; Skin nodule; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1692H~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0129560	10/19/1999	GA	38.0	38		F	10/12/1999	pt c/o hoarseness, wheezing, coughing, SOB lasting only minutes;cont w/hoarseness;									Y	10/06/1999	10/06/1999	0	NONE	PVT	PUB	NONE	scratchy throat	NKDA-no medical history	~ ()~~~In patient		1						1	Asthma; Cough; Dysphonia; Dyspnoea	FLU3~PARKDALE PHARMACEUTICALS~02779P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0129561	10/19/1999	NC	39.0	39		F	10/12/1999	tightness throat-felt heart was racing BP 137/84, HR98;Bp 122/78, HR 96;									Y	10/12/1999	10/12/1999	0		OTH	UNK	Depo vera birthcontrol;valium;	?anxiety, dizziness	pt stated that has had hx & dizziness, nausea w/out finding cause;pt on valium for dizziness;	~ ()~~~In patient		1						1	Hypertension; Laryngospasm; Tachycardia	FLU3~CONNAUGHT LABORATORIES~U0144AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129562	10/19/1999	WI	63.0	63		F	10/11/1999	p/vax pt exp chills, throat swelling which defined & being unable to swallow;watery eyes & later that noc, emesis;resolved during noc;no tx;									Y	10/07/1999	10/07/1999	0	NONe	PVT	OTH	Premarin	NONE	NONE	~ ()~~~In patient		1						1	Chills; Lacrimal disorder; Laryngospasm; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0127AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129567	10/19/1999	IN	74.0			F		local erythema & edema rt upper arm;erythema thorax;				Y						10/08/1999	10/08/1999	0	NONE	UNK	UNK	Claritin;Synthroid;		NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0129568	10/19/1999	KS	71.0	71		F	10/18/1999	4mm measuring by 2mm red area, throbbing;									U	10/12/1999	10/13/1999	1	NONe	PVT	UNK		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4998270~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129572	10/20/1999	WA	66.0			F	10/17/1999	rt deltoid- 24 hr p/vax, pt devel severe cellulitis w/T, inc WBC required 48hr;inpatient IV ATB;				Y	Y	2			Y	10/07/1999	10/08/1999	1		PUB	UNK		NONE	NONE	~ ()~~~In patient		1						1	Cellulitis; Leukocytosis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1402H~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0129575	10/20/1999	NY	42.0	42		M	10/12/1999	1 day post vax pt devel soreness & tenderness in rt arm;devel temp-rash around inj site rt arm-red, inflamed;inc temp 105;dx cellulitis;ATB/antiviral med;			Y	Y					N	10/08/1999	10/09/1999	1	elevatedWBC;	OTH	PVT	Amantadine;Cefadroxil	NONe	asthma, heart attack;	~ ()~~~In patient		1						1	Cellulitis; Injection site hypersensitivity; Injection site pain; Leukocytosis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0129592	10/20/1999	WA	49.0	49		F	10/13/1999	p/vax pt eyes started burning then nose, ears, mouth;went to hosp ER 4PM IV w/DPH, pred & rx for hydroxyzine HCl, difficulty swallowing;				Y					Y	10/11/1999	10/11/1999	0	NONE	OTH	UNK	takes evista	NONE	NONE	NONE~ ()~~~In patient		1						1	Ear pain; Eye pain; Laryngospasm; Stomatitis	FLU3~PARKDALE PHARMACEUTICALS~01889P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0129593	10/20/1999	NY	64.0	64		F	10/18/1999	had very painful rt arm, unable to raise rt arm, rt arm tender to touch;was unable to sleep 10/13-10/14;c/o chest hurt-could not take a deep breath;seen by md on 10/15;started on cortisone, APAP w/codeine;				Y					Y	10/13/1999	10/13/1999	0	NONE	PUB	PVT	Zesteril, Zestoretic, Norvasc, Prevolid, Serevent, asthmacort	NONe	asthma, HTN, environmental allergies;	NONE~ ()~~~In patient		1						1	Chest pain; Hypokinesia; Insomnia; Pain; Respiratory disorder	FLU3~CONNAUGHT LABORATORIES~U0127AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1573H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0129595	10/20/1999	OR	50.0	50		F	10/07/1999	large red welt on arm measures 3 1/2 x 4 1/2-hot to touch, itchy, arm sore-tender & warm to touch-welt raised;				Y					Y	10/04/1999	10/04/1999	0	NOne	PUB	PUB	Mult meds-atrovent spray, Vanceril inhaler;albuterol inhaler;	NONE	asthma, low thyroid, BP elevated, depression	~ ()~~~In patient		1						1	Pruritus; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0103AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0129596	10/20/1999	MI	82.0	82		F	10/14/1999	temp, pain, swelling, redness-infect @ inj site-saw MD tx w/PCN;				Y					N	10/11/1999	10/11/1999	0	NONE	PUB	PUB	Paxil, Premarin	NONE		~ ()~~~In patient		1						1	Abscess; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0129597	10/20/1999	CA	69.0			F	10/13/1999	pt has temp 101.9;				Y										UNK	UNK				~ ()~~~In patient		1						1	Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0129598	10/20/1999	CA	75.0			F	10/01/1999	flu sx-tightness in chest, cough, weakness, chills, fever, body aches, loss of appetite;pharmacist rx -cough syrup;									N				NONE	OTH	OTH				~ ()~~~In patient		1						1	Anorexia; Asthenia; Chest pain; Cough; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0129600	10/20/1999	CA	50.0	49		F	10/08/1999	fine, bumps all over body-itching from head to toe-rx w/DPH cream-overnight-sx cont-pt thinks has hives;									N	10/07/1999	10/07/1999	0	NONE	PVT	PUB	Hydrochic?;Wellbtrin;Pred;Koladine, Verapamil	NONE	systemic lupus	~ ()~~~In patient		1						1	Pruritus; Rash maculo-papular; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0129601	10/20/1999	AZ	67.0	67		F	10/08/1999	soreness, swelling, red area, itching x 2 days later reduced sx remain-near inj site where pneumo vax given-not flu shot;									N	10/06/1999	10/06/1999	0	NONe	OTH	PUB	Valium;Prevasid;Diavan;Premarin cream;	NONE	grasses, tree allergy	pt exp swelling/itch @ age 57 w/pneumo~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0129602	10/20/1999	MO	66.0	66		M	10/07/1999	dizziness & weakness;									Y	10/06/1999	10/07/1999	1	NONE	PUB	PUB	Tizack	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Dizziness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0129603	10/20/1999	CA	63.0	63		F	10/05/1999	sore tongue & throat;									N	10/04/1999	10/04/1999	0	NONE	PVT	PVT	Thyroid med;water pills	NONe	HTN	~ ()~~~In patient		1						1	Glossitis; Pharyngitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0129604	10/20/1999	PA	59.0	59		M	10/12/1999	pt was not able to stand, broke out into extreme sweat then vomited several times;dizziness, severe h/a & cont to vomit;when lying down felt like are was flying;sx persist next day-not as severe but w/stiffness;									Y	10/11/1999	10/11/1999	0	NONE	PVT	OTH	NONE	NONE	novacaine & percocet allergy	~ ()~~~In patient		1						1	Dizziness; Headache; Hyperhidrosis; Hypertonia; Hypokinesia; Personality disorder; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0129605	10/20/1999	CT	78.0	78		M	10/19/1999	evening p/vax site hot, red, edematous day 2 p/vax; inner aspect rt arm red & hot to elbow;3x2.5 edematous red, hot area at & above elbow w/scattered red 3 down lower arm;day 3 PM cleared;									Y	10/14/1999	10/14/1999	0	NOE	PUB	PVT	unk	NONE	many allergies-not to eggs/thimerosol	NONE~ ()~~~In patient	CT9908	1						1	Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Vasodilatation	FLU3~PFIZER\WYETH~4998209~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1692H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0129606	10/20/1999	NE	68.0	67		F	10/19/1999	fever, rt arm swelling, pain w/extension to rt anterior chest, neck/day p/arm swelling day of vax;cough 2 days p/vax;									Y	10/15/1999	10/15/1999	0		PVT	PVT	atenolol, Maxzide, Prinivil, Rythmol	NONE	HTN, Cardiac arrhythmia	~ ()~~~In patient		1						1	Chest pain; Cough; Injection site oedema; Injection site pain; Oedema; Oedema peripheral; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0132AA~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1106J~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0129608	10/20/1999	KY				F		fever, h/a, diarrhea w/in 24hr p/vax;went on & devel chest congestion;									Y	10/12/1999	10/12/1999	0		UNK	PVT		NONE	sulf	~ ()~~~In patient		1						1	Diarrhoea; Headache; Pyrexia	FLU3~PFIZER\WYETH~4998270~UNK~A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129616	10/21/1999	PA	83.0	83		M	10/16/1999	3hr post vax pt became violently ill w/vomiting, dizziness, weakness-ER by amb;			Y	Y	Y				Y	10/13/1999	10/13/1999	0	x-ray-results unk	PVT	OTH	Lanoxin;Isoptin;Cardura;Zantac;Reglin	NONE	caines-allergies-PCN	pt violently ill w/vomit, dizziness, weakness @ age 82 w/flu vax;~ ()~~~In patient		1						1	Asthenia; Dizziness; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0129620	10/21/1999	NC	66.0	66		F	10/14/1999	p/vax pt returned to clinic 10/14 to show site to nurse;arm over site swollen, red w/redness extending down to elbow-red flat splotches under site (no infect noted);pt has been applying compress;				Y					Y	10/11/1999	10/11/1999	0	NONE	PUB	PUB		NONE	NONE	NONE~ ()~~~In patient	NC99074	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4998242~5~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TTOX~CONNAUGHT LABORATORIES~250211~2~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0129621	10/21/1999	OH	36.0	36		F	10/19/1999	cool, clammy skin, weak, vomiting, dec BP 92//60, dizziness administered 0.5ml of epi, called & transported by squad to nearest hosp;				Y					N	10/19/1999	10/19/1999	0		OTH	PVT	prozac	NONE	PCN	~ ()~~~In patient		1						1	Asthenia; Chills; Dizziness; Hyperhidrosis; Hypertension; Vomiting; Asthenia; Dizziness; Hyperhidrosis; Hypotension; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0150AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0150AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0129622	10/21/1999	MN	53.0	53		F	10/20/1999	p/vax pt had T100.6 & c/o bodyaches;on 10/19/99 pt felt worsened & sent to see family MD;MD advised pt was having adverse rxn to shot;				Y					U	10/15/1999	10/18/1999	3		OTH	UNK		NA	hayfer	NONE~ ()~~~In patient		1						1	Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0128AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0129625	10/21/1999	KY	42.0	42		F	10/14/1999	difficulty breathing, hoarseness, paleness, weakness, fast heart beat-MD dx spasmatic bronchial bronchial tubes;given meds amoxicillin-Benzonalate;				Y					Y	10/13/1999	10/13/1999	0	NONE	OTH	PUB	NONE	NONE	anaprox allergy	~ ()~~~In patient		1						1	Asthenia; Bronchitis; Dysphonia; Dyspnoea; Pallor; Tachycardia	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0129634	10/21/1999	WI	38.0	38		M	10/13/1999	allergic rxn: red, watery eyes, congestion, tightness in chest, constricted feeling in throat, wheezing, coughing, diff swallowing onset was rapid, going from no sx to full blown in about 15min;bodyaches & low grade fever;tx w/pred;				Y					Y	10/12/1999	10/12/1999	0	NONE	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Asthma; Chest pain; Conjunctivitis; Cough; Hypersensitivity; Laryngospasm; Myalgia; Pyrexia; Rhinitis	FLU3~PARKDALE PHARMACEUTICALS~02979P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0129636	10/21/1999	CA	41.0	40		F	10/08/1999	redness, warmth approx 3 diameter @ inj site w/ c/o mild itching, 24hr p/vax;									Y	10/01/1999	10/02/1999	1		PVT	PVT	Prozac	NONE	hx depression x 2yr;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4998211~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129637	10/21/1999	CA	30.0	30		F	10/08/1999	diarrhea, generalized mild edema, facial eczema w/moderate itching on 10/5/99;sx free on 10/6/99 x/several spots on face & neck;									Y	10/04/1999	10/05/1999	1	NONE	PVT	UNK		NONE	hx of eczema	~ ()~~~In patient		1						1	Diarrhoea; Eczema; Oedema	FLU3~PFIZER\WYETH~4998211~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~SMITHKLINE BEECHAM~3132A6~2~IM~LA~HEP B (ENGERIX-B)~1	USA		Influenza
0129638	10/21/1999	CA	41.0	41		U	10/08/1999	10/7/99 in AM rt arm @ vaccine site w/erythema, inflammation 2 diameter;T100;10/8/99 rt cervical lymph node enlarged;rt ear stuffy;no pain/drainage;									Y	10/06/1999	10/07/1999	1	NONE	PVT	UNK		NONE		~ ()~~~In patient		1						1	Ear disorder; Injection site hypersensitivity; Injection site inflammation; Lymphadenopathy; Pyrexia	FLU3~PFIZER\WYETH~4998211~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129639	10/21/1999	CA				F	10/11/1999	red raised rash to chest, anterior neck, upper back & rt forearm (inner aspect) approx 3 days p/flu vax;pt states also started new med approx 10 days ago;afeb;										10/06/1999				PVT	UNK				~ ()~~~In patient		1						1	Rash maculo-papular	FLU3~PFIZER\WYETH~4998211~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129640	10/21/1999	CA	52.0	51		F	10/11/1999	localized redness/inflammation @ inj site 3-4 & swelling of lymph node axillae lt, mild h/a;sx gradually resolved by 10/11/99;									Y	10/08/1999	10/09/1999	1	NONE`	PVT	UNK		NONE		~ ()~~~In patient		1						1	Headache; Injection site hypersensitivity; Injection site inflammation; Lymphadenopathy	FLU3~PFIZER\WYETH~4998211~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129641	10/21/1999	TX	26.0	26		M	10/12/1999	loss of consciousness for 30sec;no other sx;vagal rxn;full recovery;									Y	10/12/1999	10/12/1999	0	NONE	MIL	MIL		NONE	NONE	~ ()~~~In patient		1						1	Syncope	ANTH~MICHIGAN DEPT PUB HLTH~FAV041~4~SC~LA~ANTHRAX (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~U0135AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129642	10/21/1999	CA	55.0	55		F	10/17/1999	swelling, redness, hot, inflammation;temp x 2 days, T101 tapering w/chills, aches & pains;extreme fatigue & weakness-arm cont to be red;splotchy, itchy x 1wk post vax;migrated towards elbow;									N	10/09/1999	10/09/1999	0	NONE	PVT	PVT	Progesterone;medroxy;Motrin;Premarin	NONe	hayfever	~ ()~~~In patient		1						1	Asthenia; Chills; Myalgia; Oedema; Pruritus; Pyrexia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0129644	10/21/1999	TX	62.0	61		F	10/16/1999	arm began to swell-pt treated w/ice packs & APAP-arm cont to swell from neck, fingers, chest area;swelling/pain cont to persist;									N	10/15/1999	10/15/1999	0	NONE	OTH	PUB	Premarin	NONE	environmental allergy mold, pollen, tree, crop dust, chocolate	pt exp rxn w/DTP dose 1~ ()~~~In patient		1						1	Lymphadenopathy; Oedema; Oedema peripheral; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0129645	10/21/1999	IN	60.0	60		M	10/15/1999	fever, chills, itching on arms & body muscle soreness, weakness x1wk-persisting;									N	10/13/1999	10/13/1999	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Myalgia; Pruritus; Pyrexia; Asthenia; Myalgia; Pruritus; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0129645	10/21/1999	IN	63.0	63		F		fever, chills, itching on arms & body muscles soreness, weakness x1wk-persisting;									N	10/13/1999	10/13/1999	0	NONE	PUB	PUB	Proxnap/APAP;Anbien;Sulondac;Gemfibrozil;Neurontin;Meclizine;Estradioal;Amitriptylin;triant/HCTZ	NONE	leg prob/pain, hip pain, sinus prob;	~ ()~~~In patient	IN99035	1						2	Asthenia; Myalgia; Pruritus; Pyrexia; Asthenia; Myalgia; Pruritus; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0129647	10/21/1999	NY	74.0	73		F	10/15/1999	site black & blue w/extreme redness & swelling;almost to elbow-hot to touch;sx persist w/continuing severity;									N	10/13/1999	10/13/1999	0	x-ray @ chiropractor negative;	OTH	PUB	Navazec	NONE	high BP, dust, mold, mites	~ ()~~~In patient		1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0129648	10/21/1999	CA	66.0	66		M	10/14/1999	swelling size of a fist @ inj site;very painful lt arm;									N	10/14/1999	10/14/1999	0	NONE	PUB	PUB	Prevaset;Depalex;heart med-zocar;	NONE	NONE	~ ()~~~In patient	CA990122	1						1	Injection site mass; Injection site oedema; Injection site pain; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0129649	10/21/1999	AZ	75.0	75		F	10/15/1999	devel sx of flu w/aching in various parts of body;no temp;yellow thick drainage w/sl cough;tired stayed in bed x 1wk;clogged nose, sneezing, sore throat;									N	10/08/1999	10/08/1999	0	NONE	PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Cough; Influenza; Myalgia; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0129650	10/21/1999	AZ	23.0	22		F	10/20/1999	redness on lt arm @ inj site measuring 38mm x 36mm;warmth, mild swelling, mild pain & pruritus;;									Y	10/19/1999	10/19/1999	0	NA	OTH	OTH	BC pills (ortho-tricycline)	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U01444AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129654	10/21/1999	WA	42.0	42		F	10/13/1999	almost immed itching under arm, around inj site lt deltoid h/a w/in 2hr;w/in 3-4hr ringing in ears, dizziness;itching persisted entire time;malaise entire time;sl hoarseness;no wheezing;diarrhea in AM of 10/13;									Y	10/12/1999	10/12/1999	0	NONE	PVT	UNK	Claritin;Advil;	felt a little under the weather for 2wk;	allergies-environemntal-dust, grasses, pollens, alder;	~ ()~~~In patient		1						1	Diarrhoea; Dizziness; Dysphonia; Headache; Injection site hypersensitivity; Lymphadenopathy; Malaise; Pruritus; Tinnitus	FLU3~PARKDALE PHARMACEUTICALS~02979P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0129655	10/21/1999	IL	60.0	60		F	10/08/1999	p/vax pt exp vomiting & dizziness;lasted about 24hr;									Y	10/06/1999	10/07/1999	1		PUB	PUB		NONE	NKA	~ ()~~~In patient	IL99064	1						1	Dizziness; Vomiting	FLU3~CONNAUGHT LABORATORIES~V0103AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129656	10/21/1999	TX	30.0	30		F	10/15/1999	redness & swelling of area where inj given;										10/13/1999	10/14/1999	1		PVT	PVT	NA	NA	NA	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PARKDALE PHARMACEUTICALS~4099G010~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0122103	10/22/1999	PA	67.0	67		F	10/08/1999	pain, numbness, tingling, tremors in lt upper arm;also occurs in lt whole leg;pt was given a cortisone shot & then prednisone;pt states has nerve damage;				Y					N	10/12/1998			N	PVT	OTH		NA	NA	NA~ ()~~~In patient		1						2	Hypotonia; Movement disorder; Myasthenic syndrome; Pain; Paraesthesia; Neuropathy; Pain; Paraesthesia; Tremor; Arthralgia; Movement disorder; Neuritis; Pain; Paraesthesia	FLU3~PARKDALE PHARMACEUTICALS~0981810~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~2|FLU3~CONNAUGHT LABORATORIES~0981810~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~3	USA	Emergency room visit	Influenza
0129663	10/22/1999	TX	18.0	18		M	10/04/1999	p/vax pt devel sz activity which lasted approx 10 seconds w/involuntary muscle contractions;no incontinence, no head injury;pt responded well & was transferred to ER for eval;pt hosp for testing which was negative;				Y	Y	2			Y	09/22/1999	09/23/1999	1	CT Scan-neg;LP neg, MRI-neg, lab test neg, EEG neg;	OTH	PVT		NONE	NONE	~ ()~~~In patient	U199900709	1						1	Convulsion; Muscle twitching	FLU3~CONNAUGHT LABORATORIES~~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~CONNAUGHT LABORATORIES~7126AA~1~~LA~MENINGOCOCCAL (MENOMUNE)~1	USA	Hospitalisation	Influenza
0129681	10/22/1999	CA	44.0	44		F	10/18/1999	3hr post vax pt devel facial swelling, total body itching-relieved w/Atarax & pred;			Y	Y					Y	10/13/1999	10/13/1999	0	NOEN	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Face oedema; Pruritus	FLU3~PFIZER\WYETH~4998213~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening	Influenza
0129683	10/22/1999	MA	43.0	43		F	10/20/1999	hands started to itch;moved up arms, down side, down back, legs, feet; hives; fast heart beat;abnormal feeling in throat;30min resolved;			Y						Y	10/19/1999	10/19/1999	0	NONe	OTH	OTH	NONE	NONE	mild asthma	~ ()~~~In patient		1						1	Laryngospasm; Pruritus; Tachycardia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0129685	10/22/1999	NC	39.0	39		F	10/18/1999	weakness-so severe pt could only ambulate w/help-total lethargy, amorphous anxiety later; proven to be blood sugars 19-50;6-8wk bedridden;other pt known to have same rxn;extreme weight loss;blood sugars problem;			Y	Y				Y	U	10/01/1992	02/01/1993	123	Glucometer readings p/the fact	OTH	PUB		NONE	allergies: eggs, chocolate, cheese, peanuts, milk;	pt exp rxn @ age 39 w/flu dose 1;~ ()~~~In patient		1						1	Anxiety; Asthenia; Hypoglycaemia; Hypokinesia; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Disabling	Influenza
0129686	10/22/1999	CO	44.0	44		M	10/06/1999	@ 72hr post vax erythema @ site 13x6cm, induration/nodule 6x4cm;mild tenderness lt anterior thigh;nodule gone 18 days post vax;recipient is MD;onset 48hr post vax lasting 24hr;mild myalgia, arthralgia, fatigue;									Y	10/01/1999	10/02/1999	1	NONe	MIL	MIL	NONE	NONE	NONE	pt exp nodule, erythema @ age 43yr w/anthrax dose 2,3,4;~ ()~~~In patient		1						1	Arthralgia; Injection site hypersensitivity; Injection site mass; Injection site pain; Myalgia	ANTH~MICHIGAN DEPT PUB HLTH~FAV037~5~SC~LL~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0129688	10/22/1999	OH	38.0	38		M	10/19/1999	10/4/99 dizziness, sensitive skin on trunk, balk of arms, middle back;10/11/99 dizziness great J reduced, sensitive skin persists;10/19/99 sensitive skin persists;									U	10/02/1999	10/04/1999	2	NONE	MIL	MIL	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Dizziness; Hyperaesthesia	ANTH~MICHIGAN DEPT PUB HLTH~FAV024~2~SC~LL~ANTHRAX (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~U998235~7+~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129693	10/22/1999	VA	66.0	66		F	10/21/1999	lt arm mid to lower deltoid area w/small bruise;6cm induration, redness, warmth-no other sx;				Y					Y	10/19/1999	10/19/1999	0	NONE	PUB	PVT	coated ASS;calcium;vitamin;Pilocartine;Elvivoxin;Matoprilol;Prilosec;Lipitor;Maxide;Cader;Chloradiaz;	NONE	ragweed, hayfever;	~ ()~~~In patient		1						1	Ecchymosis; Injection site hypersensitivity; Injection site mass; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0129696	10/22/1999	NY	6.0	6		M	10/20/1999	2hr post pt broke out in hives all over body w/difficult breathing;atarax (MD rx);also lip was bleeding;placed on nebulizer still not recovered;				Y					N	10/20/1999	10/20/1999	0	NONE	PVT	OTH	Albuterol Sulfate;flovent;	asthma attack	asthma, genetic disease, cerebra atrophy;spinal deteriorate	pt exp lymph rxn @ 6mo w/DTP dose 3;~ ()~~~In patient		1						1	Dyspnoea; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0129697	10/22/1999	MN	47.0	47		F	10/18/1999	w/in 5min post vax inc 120 pulse;heaviness in chest radiating down arm;220/106;rx 02;sx decrease in 20min;chest tightness;numbness around lips, very exhausted;				Y					Y	10/18/1999	10/18/1999	0	EKG-noted PBC's	PVT	PVT	Flonase;Claritin;;Proventil;	needed bronchodilator	high BP, asthma, latex, sulfa enduron	~ ()~~~In patient		1						1	Asthenia; Chest pain; Hypertension; Hypoxia; Pain; Paraesthesia oral; Tachycardia	FLU3~CONNAUGHT LABORATORIES~00134CA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0129698	10/22/1999	OK	47.0	47		F	10/20/1999	arm swollen & red, hot, painful, pain spread to shoulder;pain increasing;				Y					N	10/19/1999	10/19/1999	0	NONE	PUB	PUB	Wellbutrin;Liptor;Estorgen;	NONE	NONE	~ ()~~~In patient		1						1	Arthralgia; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0129699	10/22/1999	GA	47.0	46		F	10/20/1999	weakness, sl fever, fast heart rate, fuzziness, dizzy, lightheaded, lt arm pain & nausea;				Y					N	10/14/1999	10/15/1999	1		UNK	UNK				~ ()~~~In patient		1						1	Asthenia; Dizziness; Nausea; Pain; Pyrexia; Tachycardia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0129700	10/22/1999	CA	48.0	48		F	10/21/1999	1hr p/vax runny nose, watery eyes, itchy mouth;tx in ER w/DPH;				Y					Y	10/20/1999	10/20/1999	0		MIL	PVT		NONE	NONE	~ ()~~~In patient		1						1	Lacrimal disorder; Pruritus; Rhinitis; Lacrimal disorder; Pharyngitis; Rhinitis	FLU3~PARKDALE PHARMACEUTICALS~02779P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PFIZER\WYETH~4998230~1~A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0129702	10/22/1999	OR	47.0	47		M	10/18/1999	numbness on lt side of body x 3 days & cont;				Y					N	10/12/1999	10/14/1999	2	unk	OTH	OTH	Hydrochlorthrazide;topril;verapamil	unk	unk	~ ()~~~In patient		1						1	Paraesthesia	FLU3~CONNAUGHT LABORATORIES~U0109BA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0129703	10/22/1999	NY	55.0	55		F	10/18/1999	severe swelling & redness from shot site;T102,arm sore, aches, pains;sought med attention				Y					N	10/13/1999	10/14/1999	1	NONE	PUB	UNK	Combivent;Cedfadroxil	NONE	asthma		NY599034	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0129706	10/22/1999	MA	37.0	37		M	10/18/1999	papular rash, extensor surfaces of arm & legs plus erythema of 1/2 of ears & all toes p/1wk;rash is maculopapular, ears peeling toes still erythematous;				Y					N	10/08/1999	10/09/1999	1	NONE	OTH	UNK	Levoxyl;Allopurinol	NONE	pediamycin rxn 11/70;downs synd;	NONE~ ()~~~In patient		1						1	Dermatitis exfoliative; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~U0107AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0129709	10/22/1999	OH	64.0	64		M	10/08/1999	p/vax pt c/o pain @ inj site that noc;10/6/99 rt arm below site of inj became red, warm & edematous;10/7/99 to MD for eval-arm rt biceps area & around to elbow still red, warm, edematous;				Y					Y	10/05/1999	10/06/1999	1	NONE	PUB	PUB	unk	NONE	possible heart disease;	~ ()~~~In patient	OH99068	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0144AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1584~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0129710	10/22/1999	OR	55.0	55		F	10/18/1999	severe myalgia, arthralgia, diarrhea, nausea, facial skin burning sensation;fluid retention, muscle spasms, intermittent SOB, weakness, fatigue;tx included PRn aldactone, cont monitoring DPH PRN, office visit;				Y					Y	10/06/1999	10/07/1999	1	NONE	PVT	PVT	Depo Estradiol Crypiorate & Depo provera;	NONE	chronic back pain, HRT	NONE~ ()~~~In patient		1						1	Arthralgia; Asthenia; Diarrhoea; Dyspnoea; Hypertonia; Myalgia; Nausea; Oedema; Pain	FLU3~PFIZER\WYETH~4998222~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0129711	10/22/1999	AK	34.0	34		F	10/15/1999	24hr p/vax pt devel soreness & pain lateral & inferior to inj sites & flu like sx w/nausea & stomach pain;inc redness & hot, red area (not directly) @ inj site;seen by MD;T99.2;rx w/rocephin;cellulitis;				Y					U	10/12/1999	10/13/1999	1		PVT	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Abdominal pain; Influenza; Injection site hypersensitivity; Injection site pain; Nausea; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4998209~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~7301BA~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0129714	10/22/1999	CA	23.0	23		F		coughing w/in 4hr, laryngitis, rhinitis 2 days later low grade fever;									Y	10/08/1999	10/08/1999	0	NONE	PVT	UNK		NONE	NONE	~ ()~~~In patient		1						1	Cough; Laryngitis; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~U0098EA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129716	10/22/1999	AZ	50.0	50		F	10/21/1999	sl swelling & redness of inj site;									Y	10/18/1999	10/19/1999	1	NONE	OTH	UNK		NONE	CHF, hiatal hernia, HTN	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~U0144AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129718	10/22/1999	CA	57.0	57		F	10/18/1999	felt unwell-inc through day;T102;nausea, trouble keeping anything down, achy, chills;									Y	10/16/1999	10/16/1999	0	NONE	PVT	OTH	Estorgen;Paxil;Progesterone	cold-prev week	NONE	~ ()~~~In patient		1						1	Chills; Malaise; Myalgia; Nausea; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0129721	10/22/1999	TN	65.0	65		F	10/19/1999	excessive chills, temp 103 x 6hr, body aches, h/a, dizzy, nausea;									Y	10/14/1999	10/14/1999	0	NONE	PVT	PVT	Norvasc;Cumudin;Estrodom;Rhinotan;Captopril;liptor;Rnetedin;chlorton;chloraden;	NONE	allergies, stomach ulcer, high BP, cholesterol, neuropathy	pt exp fl x 3 days at age 55 w/flu vax~ ()~~~In patient		1						1	Dizziness; Headache; Myalgia; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0129722	10/22/1999	KY	41.0	41		F	10/21/1999	evening p/vax pain-1 day later edema & redness;itching;										10/19/1999	10/19/1999	0		PUB	PUB	Prozac;Prevacid	NONE	Tofrinil	~ ()~~~In patient		1						1	Oedema; Pain; Pruritus; Vasodilatation; Oedema; Pain; Pruritus; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02979P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~02979P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0129723	10/22/1999	CA	53.0	53		F	10/20/1999	extreme pain in arm where shot given red, swelling, pain across entire arm-back-other arm;h/a, crawly skin, legs felt semi paralyzed;T102 & fatigue, dizzy, flu sx, congestion, swollen throat, blurred vision;									N	10/12/1999	10/12/1999	0	NONE	PVT	OTH	APAP	NONE	PCN, sodiumBenzoate, Food preservative;	~ ()~~~In patient		1						1	Amblyopia; Asthenia; Dizziness; Headache; Influenza; Injection site hypersensitivity; Injection site oedema; Injection site pain; Laryngospasm; Pain; Paraesthesia; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0129731	10/22/1999	SC	42.0	42		F	10/13/1999	swelling & solid red area @ inj site, size of pt's palm, & diarrhea x 4 & nausea;nausea & diarrhea until 4AM;redness gradually decreased & was gone by 10/11/99 AM;									Y	10/08/1999	10/08/1999	0	NA	OTH	OTH	wellbutrin, doxephin, birth control pills, claritin D;	had flu sx 1wk prior to vax;	pollen, poison ivy, severe allergies;	NONE~ ()~~~In patient		1						1	Diarrhoea; Injection site hypersensitivity; Injection site mass; Injection site oedema; Nausea	FLU3~CONNAUGHT LABORATORIES~U0134DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129737	10/22/1999	IL	72.0	72		F	10/18/1999	w/in 12hr arm swollen red & sore;72hr later had temp felt like had the flu;nauseated, stomach pain lasted through weekend;									Y	10/12/1999	10/13/1999	1		PUB	UNK	Coumndin;Feroso mid;Atitina;CatorK=;		heart disease, lung problems;	~ ()~~~In patient		1						1	Abdominal pain; Nausea; Oedema peripheral; Pain; Pyrexia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E24869GA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0129740	10/22/1999	CA	47.0			U		very dizzy & nauseous, paleness & weakness for about 24hr;									Y	10/06/1999	10/06/1999	0		OTH	UNK		NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Dizziness; Nausea; Pallor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0129748	10/22/1999	MS	68.0	67		M	10/18/1999	p/vax pt devel pain & swelling @ inj site;applied ice;progressed w/swelling & redness to elbow, resolving this AM 10/18/99;still red w/some swelling;									Y	10/15/1999	10/15/1999	0	NA	PUB	PUB		NONE		~ ()~~~In patient	MS99043	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4998232~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1584H~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0129751	10/22/1999	IA	72.0	72		F	10/19/1999	initial site soreness then approx rt 3-4 days;later muscle like weakness & rt shoulder joint discomfort/throb which persists;									U	10/06/1999	10/09/1999	3		PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Arthralgia; Injection site pain; Myasthenic syndrome; Pain	FLU3~CONNAUGHT LABORATORIES~U0077CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129760	10/25/1999	OH	46.0	46		F	10/16/1999	p/vax pt c/o redness & induration of lt upper arm;				Y					Y	10/02/1999	10/03/1999	1	NONE	MIL	MIL	NONE	NONE	NONE	pt exp low grade fever all dose varies;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4998234~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TYP~CONNAUGHT LABORATORIES~P0323~1~SC~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0129764	10/25/1999	MO	1.0	1	.0	M	10/12/1999	periorbital erythema, hives on face-no involvement w/other areas, none @ inj site, DPH elixir given PO in office;				Y					Y	10/08/1999	10/08/1999	0	NONE	PVT	PUB		NONE	NONE	NONE~ ()~~~In patient		1						1	Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0065AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1071J~1~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0445J~1~~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0129770	10/25/1999	MS	57.0	57		F	10/18/1999	p/vax pt rt arm swollen from deltoid area to approx 1 above elbow;reddened area approx 4 x 4 area to posterior area of upper arm;warm to touch no knot noted;pt states almost fainted;infection;				Y					Y	10/11/1999	10/11/1999	0	NONE	PUB	PUB		NONE	NKA	~ ()~~~In patient	MS99045	1						1	Dizziness; Infection; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4998232~7+~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~454969~2~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0129771	10/25/1999	IL	34.0	34		F	10/21/1999	devel red blotchy rash & lip swelling, heavy breathing;inc BP;had EKG done;02 sat & put on pred x 5 days & DPH;				Y					Y	10/14/1999	10/14/1999	0		MIL	UNK	NONE	NONE	allergic to PCn & codeine	~ ()~~~In patient		1						1	Dyspnoea; Face oedema; Hypertension; Rash maculo-papular	FLU3~PFIZER\WYETH~4998279~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0129774	10/25/1999	AZ	5.0	5		M	10/20/1999	p/vax site erythema ;erythema & edema/induration;erythema 8x11cm;edema/induration 5x5cm;tx warm compresses, DPH;improved transiently w/DPH;				Y					Y	10/13/1999	10/14/1999	1	NONE	PVT	PVT	NONE	NONE	failure to thrive requiring enteral feedings 10-18mo old, resolved;neuro fibromatosis;	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~PFIZER\WYETH~4998239~4~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0129775	10/25/1999	FL	1.4	1	.4	M	10/19/1999	generalized abd blotches & hives w/in 1hr of vax;rx DPH,  epi given;				Y					U	10/18/1999	10/18/1999	0	NA	PVT	OTH	PRN Albuterol;Prelone;	URi-nl;	asthma;bronchitis	~ ()~~~In patient		1						1	Rash maculo-papular; Urticaria	DTAP~CONNAUGHT LABORATORIES~7389AA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~CONNAUGHT LABORATORIES~40144AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0731J~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0129777	10/25/1999	NY	26.0	26		F	10/14/1999	p/vax rt arm sore right away, hand tingling, ?swollen, sore & numb;?nerve struck;pt states has circulation pain;dx reflux sympathetic dystrophy;				Y					U	10/14/1999	10/14/1999	0		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	NY5999037	1						1	Angiopathy; Injection site oedema; Injection site pain; Neuropathy; Oedema peripheral; Pain; Paraesthesia	FLU3~PARKDALE PHARMACEUTICALS~02979P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0129780	10/25/1999	WY	65.0	65		F	10/14/1999	p/vax that evening marked swelling, pain @ site reported;reported swollen fingers of rt hand w/tingling sensation, throbbing;saw MD 10/14/99 placed on ATB;				Y					U	10/13/1999	10/13/1999	0		PUB	UNK		NONE	diabetes	~ ()~~~In patient		1						1	Injection site oedema; Injection site pain; Oedema peripheral; Paraesthesia	FLU3~PFIZER\WYETH~499209~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~457837~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0129785	10/25/1999	GA	50.0	50		F	10/22/1999	p/vax pt devel lightheaded like was going to vomit when in restroom;nausea;sick;									Y	10/19/1999	10/19/1999	0		OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Dizziness; Hypotension; Malaise; Nausea	FLU3~CONNAUGHT LABORATORIES~U0131AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129786	10/25/1999	OH	68.0	68		M	10/20/1999	p/vax pt rt arm was sore lt arm OK; pt had little soreness is not unusual;									Y	10/19/1999	10/20/1999	1	NA	OTH	PUB	NA	NONE	NONE	NA~ ()~~~In patient		1						1	Pain	FLU3~PARKDALE PHARMACEUTICALS~02579P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~458744~UNK~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0129788	10/25/1999	KS	47.0	47		F	10/12/1999	pt began exp coughing & swollen throat around 430PM;pt was difficult to swallow ;face/eyes swelled, pain exp in back of neck & shoulder;hard to breathe;couldn't sleep very well;very tired today;									Y	10/11/1999	10/11/1999	0	NA	PUB	PVT	APAP;Loped;	NONE	PCN;Darvon codein;	NA~ ()~~~In patient		1						1	Asthenia; Back pain; Cough; Dysphagia; Dyspnoea; Insomnia; Laryngospasm; Neck pain	FLU3~PARKDALE PHARMACEUTICALS~01889P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0129789	10/25/1999	NY	49.0	49		F	10/06/1999	itching, swelling, heat & pain @ site of inj;relieved by DPH by mouth as ordered by MD;									Y	10/05/1999	10/05/1999	0		PVT	PVT			allergy to PCN	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~4998240~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129790	10/25/1999	IA	66.0	66		M	10/22/1999	p/vax pt reporting abd & leg cramping, nausea, perspiration, felt faint sx 24 or 32hr p/vax;									Y	10/19/1999	10/20/1999	1		PUB	PVT	unk	NONE	NONE	unk~ ()~~~In patient		1						1	Abdominal pain; Hyperhidrosis; Hypertonia; Nausea; Syncope	FLU3~PFIZER\WYETH~4998263~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129794	10/25/1999	OH	45.0	45		F	10/18/1999	pt became cold & achy, progressed to fever of 102.5 w/chills & severe h/a;pt called ER @ hosp & was told to take APAP for h/a;pt states still has h/a & receives moderate relief w/APAP;									Y	10/14/1999	10/14/1999	0	NONE	OTH	PUB	NONE	NONE	NONE	NA~ ()~~~In patient	OH99071	1						1	Chills; Headache; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0136AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129795	10/25/1999	AL	46.0	46		F	10/13/1999	lymphadenopathy, diarrhea, pharyngitis & aches (body)-swollen lt arm;									Y	10/11/1999	10/12/1999	1		PUB	PUB		NONE		~ ()~~~In patient	AL9919	1						1	Diarrhoea; Lymphadenopathy; Myalgia; Oedema peripheral; Pharyngitis	FLU3~PFIZER\WYETH~4998232~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129796	10/25/1999	MS	50.0	50		F	10/21/1999	p/vax both arms felt like knives going through them;flu vax site better next morning but still sore;pneumonia arm has large red, hot, swollen area about 4 diameter circular area;chills & h/a w/aching all over;									Y	10/19/1999	10/19/1999	0	NA	PUB	PUB	Plaquenel;Zoloft, Synthroid;	NONE	connective tissue disease;Sjogren Synd;Hasimoto Thyroid;Vascularitis	~ ()~~~In patient	MS99046	1						1	Chills; Headache; Injection site hypersensitivity; Injection site oedema; Myalgia; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4998232~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~454959~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0129797	10/25/1999	MS	54.0	54		F	10/20/1999	p/vax pt devel pain & weakness in rt arm & large red area about 4 inches below site of inj;no redness @ site of inj;pt only spoke to MD by phone & MD ordered DPH;									Y	10/12/1999	10/13/1999	1	NONE	PUB	PUB		NONE	HTN	NONE~ ()~~~In patient	MS99044	1						1	Myasthenic syndrome; Pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~4998283~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1584H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0129799	10/25/1999	ME	57.0	56		F	10/21/1999	pt felt head pulsating, severe h/a, chills & T101.2 immed p/vax;next day dizzy, chest pain, sore arm into armpit w/redness, no itching or swelling;									Y	10/06/1999	10/06/1999	0		PVT	OTH	Hydrochoroziazide	NONE	NONE	~ ()~~~In patient		1						1	Chest pain; Dizziness; Headache; Lymphadenopathy; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~499237~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0042J~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0129800	10/25/1999	ND	41.0	41		F	10/20/1999	p/vax felt dizzy & shaky, knees weak-later in evening felt h/a et had emesis x 1;									Y	10/19/1999	10/19/1999	0	NONE	PVT	PVT	NONE	NONE	allergy to sulfa	NONE~ ()~~~In patient		1						1	Dizziness; Headache; Myasthenic syndrome; Tremor; Vomiting	FLU3~PFIZER\WYETH~4998217~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129801	10/25/1999	CA	67.0	67		F	10/14/1999	solid red rash on rt of body, chest area & under area of rt arm;recovering, rash has dissipated to spots, swelling decreasing;some itching;no pain;no resp distress;									N	10/12/1999	10/14/1999	2	NA	PUB	PUB		NONE	amoxicillin	~ ()~~~In patient	CA990114	1						1	Lymphadenopathy; Oedema; Pruritus; Rash	FLU3~PFIZER\WYETH~4998216~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129802	10/25/1999	NY	34.0	34		F	10/19/1999	pt fainted became unresponsive for approx 1min then became conscious started coughing-911 called;									Y	10/18/1999	10/18/1999	0	phobic to certain events;	PUB	UNK		NONE		~ ()~~~In patient		1						1	Agitation; Stupor; Syncope	FLU3~CONNAUGHT LABORATORIES~U0106EA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129804	10/25/1999	NY	59.0	59		M	10/14/1999	pt recv flu vax in both arms in error;should have recv flu & pneumococcal vax;No adverse event;									Y	10/13/1999			NONE	PUB	PUB		NONE		~ ()~~~In patient	NY599036	1						1	Unevaluable event	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0129806	10/25/1999	MD	37.0	37		F	10/19/1999	p/vax pt c/o tenderness, swelling, redness lt deltoid, generalized aching worsening through day & self tx w/APAP;sx persisted & noted tender lt axilla & lt supraclavicular area;T100.5, chills;									Y	10/15/1999	10/16/1999	1		PVT	PVT	NONE	NONE	sensitivity, powdered latex gloves, MVP, h/o irritable bowel; h/o gestational DM;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Lymphadenopathy; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0128BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~UNKNOWN MANUFACTURER~462360~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0129810	10/25/1999	CA	40.0	40		F	10/14/1999	p/vax pt woke up @ 1AM w/ c/o weakness, ringing in ears, dizziness, c/o heaviness in chest;c/o nausea;no SOB; then pt fainted;still f/o weakness;									Y	10/13/1999	10/14/1999	1	NONE	OTH	PVT		NONE	bronchitis 6/23/99;hypothyroid in past	~ ()~~~In patient		1						1	Asthenia; Chest pain; Nausea; Syncope; Tinnitus	FLU3~MEDEVA PHARMA, LTD.~E24869GA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1692H~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0129811	10/25/1999	CA	27.0	27		F	10/15/1999	17hr p/vax pt devel flu like sx;fever 99.3, sore muscles, h/a;									U	10/14/1999	10/15/1999	1	NONE	PVT	PVT	Verapamil;Imitrex;Ambien;Belladonna	NONE	migraine h/a, endometriosis;	NONE~ ()~~~In patient		1						1	Headache; Influenza; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U010913A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129812	10/25/1999	IA	44.0	43		F	10/19/1999	p/vax pt devel discomfort w/lymph node enlargement lt axillary area;devel chills;sx cont through 10/17/99;took APAP d/t pain & chills;10/18/99 nausea & diarrhea;10/19;99 red & inflamed @ site;									Y	10/16/1999	10/16/1999	0	NOEn	PUB	PVT	NONE	NONE	hx spleenectomy & Epstein Barr Virus;	NONE~ ()~~~In patient		1						1	Chills; Diarrhoea; Injection site hypersensitivity; Injection site inflammation; Lymphadenopathy; Nausea; Pain	FLU3~PFIZER\WYETH~4998263~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~461153~5~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0129813	10/25/1999	VA	83.0	83		F	10/15/1999	p/vax pt w/SOB;pt used routine asthma inhalers w/o relief;also used proventil in nebulizer to get relief;also states approx 3 below inj site noted 5x5 area of hematoma;also c/o swelling & soreness to arm;									Y	10/11/1999	10/11/1999	0	NA	PUB	UNK	Zocorr;Norvasc;ASA;Acclead, Allegra D;B12 shot;	NONE	asthma;	~ ()~~~In patient	VA99053	1						1	Dyspnoea; Injection site haemorrhage; Oedema peripheral; Pain	FLU3~PARKDALE PHARMACEUTICALS~03179P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130644	10/25/1999	CA	71.0			F	10/20/1999	p/vax pt recv Pravachol for tx of hypercholesterolemia;10 day later pt devel toxic epidermal necrolysis;pt hosp;					Y				U	09/01/1999	09/01/1999	0	unk	OTH	OTH	Celecoxib;Hydrochlorothiazide	unk	drug hypersensitivity;hypercholesterolaemia;HTN NOS;osteoarthritis NOS;		2264413OCT199	1						1	Epidermal necrosis	FLU3~PFIZER\WYETH~~UNK~SC~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0129621	10/26/1999	OH	36.0	36		F	10/19/1999	cool, clammy, skin, weak, vomiting, decreased BP 92/60, dizziness given epi;called & transported by squad to nearest hosp;				Y					N	10/19/1999	10/19/1999	0		OTH	PVT	Prozac	NONE	PCN	~ ()~~~In patient		1						2	Asthenia; Chills; Dizziness; Hyperhidrosis; Hypertension; Vomiting; Asthenia; Dizziness; Hyperhidrosis; Hypotension; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0150AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0150AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0129700	10/26/1999	CA	48.0	48		F	10/22/1999	runny nose, runny eyes, itchy throat, sneezing, sent to ER;			Y	Y					Y	10/20/1999	10/20/1999	0	NONE	PVT	PVT	Lotenson	NONe	PCN & ASA allergy;hx of HTN	~ ()~~~In patient		1						2	Lacrimal disorder; Pruritus; Rhinitis; Lacrimal disorder; Pharyngitis; Rhinitis	FLU3~PARKDALE PHARMACEUTICALS~02779P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PFIZER\WYETH~4998230~1~A~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Life Threatening	Influenza
0129814	10/26/1999	MD	43.0	43		M	10/18/1999	p/vax pt devel encephalopathy;pt became disoriented, devel renal failure & is comatose;spinal tap showed 32 white cells;fluid sent to lab for dx;			Y	Y	Y					10/08/1999			A spinal tap revealed 32 white cells and fluid has been sent our for diagnosis;	PVT	UNK	Rocephin	NONE	ulcer	~ ()~~~In patient	U199900732	1						1	CSF test abnormal; Coma; Confusional state; Encephalopathy; Renal failure	FLU3~CONNAUGHT LABORATORIES~U0094AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0129826	10/26/1999	WI	77.0	77		F	10/25/1999	p/vax pt found dead by husband on 10/7/99;it was reported by pt husband that on 10/6/99 pt had a cough & chest congestion;pt was never seen by MD not in whole life;pt always treated self w/all kinds of herbs & vitamins;	Y	10/07/1999							N	10/06/1999	10/07/1999	1		UNK	UNK				~ ()~~~In patient	U199900751	1						1	Cough; Lung disorder; Myocardial infarction; Right ventricular failure; Myocardial infarction; Right ventricular failure	FLU3~CONNAUGHT LABORATORIES~U0126FA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0126FA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~459039~1~IM~RA~PNEUMO (PNU-IMUNE)~2	USA	Results in Death	Influenza
0129827	10/26/1999	IN	33.0	33		M	10/22/1999	p/vax pt was found dead by family member;exact time of death has not been established;autopsy to determine COD is being conducted 10/21/99;	Y	10/20/1999							N	10/20/1999	10/20/1999	0		UNK	UNK	baclofen IV, morphine sulfate		quadriplegic	~ ()~~~In patient	U199900750	1						1	Unevaluable event	FLU3~CONNAUGHT LABORATORIES~U0096BA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0129832	10/26/1999	AL	79.0	79		M	10/25/1999	w/in 24hr of vax given in lt arm swelling pain;					Y	2			Y	10/20/1999	10/23/1999	3	mild leukocytosis-WBC-11K;creat 1.8; (sl inc eosin 6%);	PVT	PVT	Dyazide/Celebrex	NONE	HTN;Gout;DJD;Cerebravascular disease;	~ ()~~~In patient		1						1	Arthritis; Leukocytosis; Oedema peripheral; Pain	FLU3~PFIZER\WYETH~4998224~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0129835	10/26/1999	CA	50.0	50		F	10/20/1999	24hr post vax pt exp chest pain & devel achiness, fatigue;adm to  hosp to r/o MI;hx fibromyalgia dx 10/97;rx w/multi meds/stopped in hosp & aches occurred p/meds;				Y	Y	2			Y	10/11/1999	10/12/1999	1	EKG & stress nuclear profusion study nl	OTH	PUB	Vancinase;Estorgens, Premphase;Ultram, arthotech, pamolor, prosac, allegra, zantac;	NONE (3wk prior bronchitis)	allergies, type II diabetes, fibromyalgia;	pt exp flu-like sx @ age 40 w/influenza vax;~ ()~~~In patient		1						1	Asthenia; Chest pain; Pain	FLU3~MEDEVA PHARMA, LTD.~E26919HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0129839	10/26/1999	LA	62.0	62		F	10/02/1999	p/vax pt fell for no reason;rt leg became stiff & wouldn't hold pt up even w/cane or walker;then couldn't move other leg; told all muscle tone was gone from both 12/12/00 states the pt remains wheel chair bound due to the paralysis of legs. A Foley catheter in place due to excessive accumulation of fluid and congestive heart failure.				Y	Y	5		Y	N	10/04/1998	11/03/1998	30	extensive lab tests, mylogram, MRI's, Spinal tap x 2; biopsy of vertebrae & spinal fluid, EMG all neg or WNL	PVT	OTH	K-dur;lasix;glucotrol;imdur;zantac;& other meds	NONE	CHF w/MI & TAP 2 vagal by pass, diabetes, dec BP, arttrition, cathetes for kidney control, bilat leg paralysis, chronephritis;			1						1	Cardiac failure; Hypertonia; Hypokinesia; Hypotonia; Injury; Paralysis	FLUX~UNKNOWN MANUFACTURER~~6~SC~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0129840	10/26/1999	TX	42.0	42		F	10/25/1999	w/in 24hr of vax pt devel very severe muscle aches & pains over entire body;fever, chills, one site became red, hot, inflamed, swollen, dx cellulitis;rx ATB;Annual follow-up dated 11/28/00 provided a change of address. Edit made.			Y	Y					N	10/17/1999	10/18/1999	1	NONE	OTH	OTH	Prilosec;Acyclovir;Wellbutrin	NONE	IV contrast allergy			1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Myalgia; Pyrexia	DT~UNKNOWN MANUFACTURER~~UNK~~LA~DT ADSORBED (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0129841	10/26/1999	PA	51.0	51		M	10/25/1999	swelling @ inj site on both arms;				Y	Y	2			Y	10/14/1999	10/15/1999	1		UNK	UNK	Lasix, Coumadin, KDur, Prilosec, Clorzoxasone, Albuterol MDI, Prednisone, Accolate, Serevent MDI	NO	asthma/reactive airway; polymyalgia rheumatica; s/p phlebitis & recurrent PE; multiple allergies:  PCN, Cipro, Keflex, ASA, Sulfa, Polysporin-Neosporin			1						1	Anaemia; Injection site oedema	FLU3~PFIZER\WYETH~4898226~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~459038~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0129843	10/26/1999	NY	62.0	62		F	10/22/1999	dizzy, trouble navigating, could not eat, dizziness progressed-could not walk;sx residing but not fully recovered; no sense of balance;			Y						Y	10/20/1999	10/20/1999	0	NONE	PVT	OTH	PPD by Connaught lot# 250211 given 10/20/99;MVI; Caltrate;Vit E;ASA;Triamterine;Provacol;asthma inhaler;	NONE	PTCA (MAY99), asthma, high BP, high chol			1						1	Anorexia; Coordination abnormal; Dizziness; Hypokinesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0129845	10/26/1999	SC	30.0			F	10/13/1999	p/vax pt felt that throat was closing up;BP 158/88, pulse 128;sent to hosp ER;tx w/DPh & 02;pt given Epipen to have on hand if needed over next few days;pt devel chills & fever relieved w/APAP; next day pt w/ no further c/o									Y	10/12/1999	10/12/1999	0		UNK	UNK	Nicotine Patch		NKA;pt never had flu shot a/; pt trying to quit smoking;	~ ()~~~In patient		1						1	Laryngospasm; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0145BA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129859	10/26/1999	MD	27.0	27		F	10/22/1999	breast milk dried up w/in 2 days of getting vax;breastfeeding since 1st delivery on 8/15/98;got 2 subsequent anthrax shots on 4/29 & 5/13/99;									N	04/15/1999	04/17/1999	2	NONE	MIL	MIL	Birth Control Loval	NONE	clubbed feet, kidney reflux in first born 8/15/98	pt devel LOC @ age 18 w/cholera;~ ()~~~In patient		1						1	Galactorrhoea	ANTH~MICHIGAN DEPT PUB HLTH~FAV043~1~SC~~ANTHRAX (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~0968420~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129862	10/26/1999	WI	29.0	29		M	10/20/1999	p/vax pt had pain in my rt shoulder, armpit & elbow;whole arm felt like the circulation & low;cold & finger were sl blue probably d/t swelling;T99.7;could not sleep;sore all over;T101.5;high fever d/t dehydration;cellulitis;redness;				Y					N	10/14/1999	10/14/1999	0		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Cellulitis; Cyanosis; Dehydration; Insomnia; Leukocytosis; Myalgia; Oedema; Pain; Peripheral vascular disorder; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0096EA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SMITHKLINE BEECHAM~2994D6~2~IM~RA~HEP B (ENGERIX-B)~1|PPV~MERCK & CO. INC.~1291H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0129863	10/26/1999	NC	51.0	51		F	10/14/1999	p/vax c/o tingling around eye;w/in 8min began itching on neck;DPH given;throat closing;911 called;				Y					Y	10/07/1999	10/07/1999	0		PUB	PUB	Effexor;Prevacid;Fosemax;Cortroid;Claritan;Medimor;Dynacac;Klonopin;Seroquel;Trazadone;Nasonox;Tylor;B tox inj;	NONE	doxycycline-hives;itching;panic disorder;	~ ()~~~In patient	NC99080	1						1	Eye disorder; Laryngospasm; Paraesthesia; Pruritus	FLU3~PFIZER\WYETH~4998223~7+~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0129870	10/26/1999	FL	74.0	74		F	10/20/1999	itching 48hr p/vax lt arm started bruising which extended to the elbow;MD called & said became jaundiced;MD felt bruising probably not from vax;poss bile obstruction;				Y					N	10/08/1999	10/10/1999	2	CT scan & other p/jaundice observed;	PUB	PUB	Prempro;Bafferine;HCTZ;		environmental	NONE~ ()~~~In patient	FL99040	1						1	Ecchymosis; Gastrointestinal disorder; Jaundice; Pruritus	FLU3~MEDEVA PHARMA, LTD.~E24449GA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0129872	10/26/1999	VT	60.0			M	10/20/1999	myalgia, arthralgia, vertigo;				Y					Y					OTH	UNK				~ ()~~~In patient		1						1	Arthralgia; Myalgia; Vertigo	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0129874	10/26/1999	ID	44.0	44		F	10/21/1999	flushed face/neck, tightness & wheezing in chest, mild asthma, tightness in throat;				Y					Y	10/20/1999	10/20/1999	0	NA	PVT	PVT		NONE	hx asthma-no event last 2years	~ ()~~~In patient		1						1	Asthma; Chest pain; Laryngospasm; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0130AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0129875	10/26/1999	OR	76.0	76		F	10/22/1999	pt rt arm swollen from deltoid to elbows;				Y					Y	10/19/1999	10/20/1999	1	NONE	OTH	UNK	ITP, Thyroxine	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site oedema	FLU3~PARKDALE PHARMACEUTICALS~02089P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~458746~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0129878	10/26/1999	WI	21.0	21		M	10/21/1999	pt passed out & was assisted to the floor;pt had some sz activity lasting a few seconds;pt found out from mom that is allergic to diphtheria in Td;				Y					Y	10/18/1999	10/18/1999	0		OTH	PVT	NONE	NONE	pt did not know about diptheria allergy;	pt devel sz w/DTP unk dose;~ ()~~~In patient		1						1	Convulsion; Syncope	FLU3~PFIZER\WYETH~4998236~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~U0010AA~6~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0129881	10/26/1999	IL	28.0	27		F	10/19/1999	lightheaded;dizzy, neck hurt, pvt MD notified;very dizzy upon standing, chest pain/tightness;sl red, puffy, firm, chest tightness, neck pain radiating up from lt arm;called MD to ER;				Y					Y	10/18/1999	10/18/1999	0	NONE	OTH	PVT	NONE	NONE	allergy to sulfa;mitral valve prolapse	pt sibling was lightheaded, arm swollen @ age 36, 38 wflu vaxdose 2;~ ()~~~In Sibling		1						1	Chest pain; Dizziness; Neck pain; Oedema; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4998251~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0129883	10/26/1999	CT	51.0	51		F	10/19/1999	pt c/o dizziness, sweatiness, racing pulse & heaviness in chest;pulse approx 90;BP 150/90;pt went to ER via ambulance;according to pt had wheezing in all 4 lobes;was given 02 for 6hr;next day arm red & hot;				Y					Y	10/16/1999	10/16/1999	0	unk	PUB	PUB	Premarin	hx of asthma, multiple allergies, fibromyalgia, neuropathy, arthritis;	hx of asthma, multiple allergies, fibromyalgia, neuropathy, arthritis;pt stated has multiple food, environmental;medication allergies;	~ ()~~~In patient	CT9909	1						1	Asthma; Chest pain; Dizziness; Hyperhidrosis; Hypertension; Hypoxia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E24309GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0129889	10/26/1999	CA	51.0	51		F	10/12/1999	primarily n/v;also c/o h/a & body aches;seen by PMD;sx resolved w/in 48hr;				Y					Y	10/04/1999	10/04/1999	0	NONE	OTH	PVT	Tratodone;	NONE	NONE	NA~ ()~~~In patient		1						1	Headache; Myalgia; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0067AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0129891	10/26/1999	NY	70.0	70		F	10/22/1999	swelling below inj site area sl erythema swelling extends to below elbow;pt notes heat but not itchy;				Y					U	10/20/1999	10/21/1999	1	NONE	PVT	PVT	NONE	NONE	amoxicillin;scoliosis;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~499E264~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0129893	10/26/1999	WY	44.0	44		F		24hr p/vax pt noted red area on inside of lt upper arm;below & medial to inj site;10/15/99 redness, swelling & extreme pain across bicep below shot site;saw MD on 101/6/99 dx w/infect & placed on cephalexin;				Y					Y	10/13/1999	10/24/1999	11	NONE	PUB	PUB	Humolog insulin	NONE	insulin dependent diabetic, heart murmur, allergic to PCn,Dopone;	NONE~ ()~~~In patient	WY9911	1						1	Infection; Injection site hypersensitivity; Injection site oedema; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4998209~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~459837~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0129895	10/26/1999	TX	56.0	56		M		p/vax pt noticed raised bumps (not red at first) @ inj site & redness across chest & then to arm;									Y	10/05/1999	10/07/1999	2	NONE	OTH	PVT	Norvasc;Prilosec;	NONE	PCN allergy	~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PFIZER\WYETH~4998281~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129898	10/26/1999	HI	8.0	8		F	10/14/1999	p/vax mom reported pt devel a rash around mouth, swelling & welts to eyes & eyelids, sl inc in cough									Y	10/13/1999	10/13/1999	0	NONE	PVT	PVT	Proventil;tilade	NONE	asthma	~ ()~~~In patient		1						1	Cough; Face oedema; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0109BA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129899	10/26/1999	CO	64.0	64		F	10/21/1999	p/vax exp light diarrhea, sneezing x 7 days, cough;pt also resp rash starting on arms of inj site, trunks & extremities;rash described as hard & itchy;lungs & redness @ inj site 2 1/2 inches wide;									Y	10/13/1999	10/14/1999	1	NONE	PUB	PUB	Daypro;Estrogen;Zantac;Vitamins	NONE	NONE	pt exp flu-like sx @ age 63 w/influenza vax;~Influenza (Seasonal) (no brand name)~UN~63.00~Patient		1						1	Cough; Diarrhoea; Injection site hypersensitivity; Injection site mass; Pruritus; Rhinitis	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0129904	10/26/1999	NC	52.0	52		F		lt arm dec inj site redness & warm to touch;Keflex & DPH given;									Y	10/11/1999	10/13/1999	2	NA	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	NC099078	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~03279P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1402H~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0129907	10/26/1999	CA	41.0	41		F	10/21/1999	p/vax pt felt itching;noticed red prickly bumps over arms & legs;all body even eyes itchy;DPH given;									Y	10/21/1999	10/21/1999	0		PUB	OTH	NONE	status post CA brest	allergic Darvocet, vancomycin, PCN, codeine;	~ ()~~~In patient		1						1	Pruritus	FLU3~PFIZER\WYETH~4998344~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129910	10/26/1999	MA	47.0	47		F	10/21/1999	approx 3hr later pt devel hive on forehead, legs itchy, back itchy, lips itchy & head/scalp itchy;tx non initially;6hr later took DPH, DPH, itchy completely stopped;									Y	10/20/1999	10/20/1999	0	NA	PUB	PVT	Levix;Hormone patch	NONE	h/o hypothyroidism;	~ ()~~~In patient		1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0128CA~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129912	10/26/1999	AL	51.0	51		M	10/19/1999	chills, fever, sore throat, cough, muscle aches since vax (6 days duration);									N	10/13/1999	10/13/1999	0	NONE	OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Cough; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0067AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129913	10/26/1999	GA				F	10/20/1999	2 lumpy hives that became 1 hive directly above site of pneumonia vax site rt deltoid;hives the size of marbles;stiff neck;instructed to apply ice to area;									Y	10/12/1999	10/19/1999	7	NONE	OTH	PVT	Evista Prilosec mult vitamin;Calcium, zinc magnesium tablets & vit C tab;	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Nuchal rigidity	FLU3~PFIZER\WYETH~4998293~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0042J~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0129914	10/26/1999	CT	65.0	65		F	10/15/1999	pt c/o tingling in lt arm around the inj site;site examined +tenderness, +hardness;pt instructed to put ice on it & take DPH;no hives;no diff breathing;									Y	10/15/1999	10/15/1999	0		PUB	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~MEDEVA PHARMA, LTD.~E26119HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0129915	10/26/1999	PA	52.0	52		F	10/22/1999	swollen area over inj site, 2 1/4 x 2-purple, red bruised in appearance, ecchymotic, warm to touch x 4 days;inj site burned when it was administered;									Y	10/06/1999	10/06/1999	0	NONE	OTH	PVT	Famotidien, Prempro, Mult vitamin	NONE	allergic-Caffeine, Codeine, Demerol, Ephedrine;	~ ()~~~In patient		1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4998272~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129917	10/26/1999	VA	73.0	73		F	10/21/1999	rash-presented to office on 10/16-no distress;									U	10/14/1999	10/15/1999	1		PUB	UNK	Atenolol;Synthroid		NKA, Eczema, hypothyroidsim	~ ()~~~In patient		1						1	Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0129919	10/26/1999	CA	30.0	30		F	10/19/1999	p/vax pt noted erythema @ site on lt arm;1hr ago noted pruritus & induration & pain;now w/6cm erythema & induration;sl warm to touch;non tender, no axillary adenopathy;									N	10/18/1999	10/19/1999	1	NA	PUB	PUB	Neurontin	NONE	rt ulnar nerve decompression w/persisting neuralgia	NONE~ ()~~~In patient	CA990120	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Pruritus; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E26919HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0129920	10/26/1999	NY	51.0	50		M		severe dizziness & very pale;the dizziness lasted about 1hr 5minutes;									Y	10/22/1999	10/22/1999	0	NONE	OTH	PVT	NONE	NONE	PCN & hayfever	NONE~ ()~~~In patient		1						1	Dizziness; Pallor	FLUX~UNKNOWN MANUFACTURER~U0109BA~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0129922	10/26/1999	CO				F	10/21/1999	p/vax pt felt dizzy & ill;next day noticed arm swollen & painful 10/21/99;arm shoulder noted w/swollen, mild erythema;									U	10/19/1999	10/19/1999	0	NONE	PUB	UNK	Premarin, sleeping Pill,Clnother Houman	NONE	NONE	NA~ ()~~~In patient		1						1	Dizziness; Malaise; Oedema peripheral; Pain; Rash	FLU3~CONNAUGHT LABORATORIES~0U0130AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129924	10/26/1999	GA	72.0	72		F	10/21/1999	p/vax small red patches on arm just below inj site (lt deltoid);pt states that felt bad & slept all day;pt took APAP;pt states this AM 10/21/99 arms has raised area w/redness & warm to touch, but not as uncomfortable as on 10/20/99;									U	10/19/1999	10/20/1999	1	NA	PUB	OTH	Calcium;Fosamax;Benozepril;Darvocet PRn;	NONE	allergy to PCN & tetanus;hx of hypertension;	pt exp rxn @ age 30 w/tetanus vax;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Malaise; Somnolence; Vasodilatation; Injection site hypersensitivity; Injection site mass; Malaise; Somnolence; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02979P~4~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~455938~2~IM~LA~PNEUMO (PNU-IMUNE)~1|FLU3~PARKDALE PHARMACEUTICALS~02979P~4~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~PFIZER\WYETH~455938~2~IM~LA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0129925	10/26/1999	GA	22.0	22		F	10/21/1999	itching @ inj site;rash thighs;rash on chest, arms & legs;hives-severe on thighs;states applied hydrocortisone ointment;did not take anything by mouth;came to clinic-no hives or rash;									Y	10/19/1999	10/19/1999	0		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Rash; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~02979P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0129926	10/26/1999	NE	36.0	35		F	10/18/1999	p/vax lt arm hurt throughout weekend;began to devel flu s/s, cold chills, sweats, achy body, n/v, h/a, lightheaded;had exposure to illness;									Y	10/15/1999	10/17/1999	2		PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Chills; Dizziness; Headache; Hyperhidrosis; Injection site pain; Myalgia; Vomiting; Chills; Dizziness; Headache; Hyperhidrosis; Influenza; Myalgia; Pain; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0129AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0129AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0129928	10/26/1999	GA	51.0	51		F	10/20/1999	pt noticed movable knot over lt clavicle not painful but awareness of knot;inj given lt deltoid;no other sx x/h/a;10/19 no discrete mass;movable 1cm knot felt;?lymph node;										10/19/1999	10/20/1999	1	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Headache; Skin nodule	FLU3~CONNAUGHT LABORATORIES~U0131AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129934	10/26/1999	WI	17.0	17		F	10/21/1999	fever 101;pulse 100;sore arm;									U	10/19/1999	10/20/1999	1	NOEn	PVT	PVT	asthma meds	NONE	asthma	pt exp rxn w/pneumoia vax;~ ()~~~In patient		1						1	Myalgia; Pyrexia; Tachycardia	FLU3~PFIZER\WYETH~499217~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1573H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0129936	10/26/1999	IL	26.0	26		F	10/18/1999	p/vax pt felt a little dizzy & in the afternoon notice lt upper arm deltoid very itchy, red, swollen & small vesicle @ site;									Y	10/15/1999	10/16/1999	1	NA	PVT	PVT	NA	NONE	HTN	NA~ ()~~~In patient		1						1	Dizziness; Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0128EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129937	10/26/1999	GA	37.0	37		M	10/19/1999	rt upper extremity paresthesias/pain  down to fingertips;(however does have +neck sx-?pre-existing problem);referred for ortho eval;										10/01/1999	10/01/1999	0		PVT	UNK		NONE	NONE	NONE~ ()~~~In patient		1						1	Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~U0131AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129938	10/26/1999	AZ	7.0	7		F	10/18/1999	approx 5min p/vax pt had a sz lasting under 1min;									Y	10/18/1999	10/18/1999	0		PVT	PVT		NONE		NA~ ()~~~In patient		1						1	Convulsion	FLU3~PARKDALE PHARMACEUTICALS~03279P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0129939	10/26/1999	VA	53.0	53		F	10/14/1999	rapid heartbeat-6hrs;12midnight 12/12/99 to 6AM 12/13/99;									Y	10/12/1999	10/12/1999	0		PUB	PVT	NONE	NONE	mitral value prolapse, allergy shots0bordust, molds, trees, grasses;	~ ()~~~In patient		1						1	Tachycardia	FLU3~PARKDALE PHARMACEUTICALS~02089P~7+~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0129940	10/26/1999	CA	58.0	58		F	10/18/1999	woke @ 2AM to acute shoulder pain @  site of inj;discovered indurated area @ site of inj w/erythema;extremely hot to touch & deep pain;(induration seemed to proceed downward into tissue burning hot;fever;									N	10/16/1999	10/17/1999	1		OTH	PVT		NONE	NONE	NONE~ ()~~~In patient		1						1	Arthralgia; Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0144AA~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129941	10/26/1999	CA	43.0	43		M	10/18/1999	1 day p/vax felt like kicked inches on rt side;extreme sharp pain from front chest around rt side;labored breathing;T99.9, chills, generalized achiness, weakness, dizziness;chiropractic adjustment gave no relief;									U	10/15/1999	10/16/1999	1		UNK	UNK		NONE	NONE	NONE~ ()~~~In patient		1						1	Asthenia; Chest pain; Dizziness; Dyspnoea; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0144AA~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129942	10/26/1999	KS	38.0	38		F	10/18/1999	p/vax around 730PM started feeling achy & very sore muscles & joints became nauseated for a few hours;was achy & sore until Thurs.;									Y	10/11/1999	10/11/1999	0	NONE	PVT	PVT	Triamteinl;mult vitamin;Verepamil;Theour;Calcium;Vit E;Vit C;	NONE	asthma diabetes;hypothyroidism;	~ ()~~~In patient		1						1	Arthralgia; Myalgia; Nausea	FLU3~PFIZER\WYETH~4998259~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129943	10/26/1999	CT	37.0	37		F	10/19/1999	pt described 1st feeling shaky & noted that arm was red, swollen & itchy;felt heart was racing & throat felt funny;lasted for 3hr then began to poss;pt did not seek an medical attention;									Y	10/14/1998	10/14/1999	365		PUB	PUB	Prevacid	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Laryngospasm; Pruritus; Tremor	FLU3~PARKDALE PHARMACEUTICALS~E24309GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0129944	10/26/1999	MI	66.0	66		F	10/19/1999	swelling & itching increasing in size lt deltoid & down back of arm tx w/atarax & cold compress;									U	10/15/1999	10/16/1999	1	NA	PVT	PVT	synthroid;Surmontil, Motrin, Beconase, Chlortramitrem;Orthoest, Provers, Antivert, ASA, Probanthine;	NONE	sulfa, Ionomine, Erythromycin if taken w/seldone;HTN;allergic rhinitis	~ ()~~~In patient		1						1	Injection site mass; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4998217~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|OPV~PFIZER\WYETH~458745~1~SC~LA~POLIO VIRUS, ORAL (ORIMUNE)~1	USA		Influenza
0129949	10/26/1999		40.0	40		F	09/07/1999	pt had hives one on each arm under both eyes & lt under arm;pt stated that hives itch;pt devel urticaria-30min p/vax which responded to DPH;									Y	09/07/1999	09/07/1999	0	NONE	MIL	MIL	NONE	NONE	NONE	pt exp rxn @ 12yr w/Td dose 2;~ ()~~0.00~Patient		1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0981351~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0212H~2~IM~LA~HEP A (VAQTA)~1	USA		Influenza
0129951	10/26/1999	MI	44.0	44		M	10/18/1999	24hr p/vax devel circular rash, redness, hardness @ inj site;									Y	10/04/1999	10/05/1999	1	NONE	PUB	OTH		NONE	+hep C	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4998217~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129952	10/26/1999	CA	62.0	61		F	10/15/1999	rash;									Y	10/10/1990	10/07/1999	3284		PVT	PVT	NONE	NONE		~ ()~~~In patient		1						1	Rash	FLU3~CONNAUGHT LABORATORIES~U0102AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129953	10/26/1999	CA	42.0	42		F	10/15/1999	generalized rash, pruritus, mouth ulcer;									Y	09/30/1999	10/01/1999	1		PVT	PVT	NONE	NONE		~ ()~~~In patient		1						1	Pruritus; Rash; Stomatitis	FLU3~CONNAUGHT LABORATORIES~U0102AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129957	10/26/1999	CA	48.0	48		F	10/12/1999	c/o sever body aches, fever, nausea x 36hr;resolved w/o medical attention;									Y	10/04/1999	10/04/1999	0		OTH	PVT	Premarin & vitamins	NONE	NONE	NA~ ()~~~In patient		1						1	Myalgia; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0067AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129958	10/26/1999	CA	49.0	49		F	10/12/1999	c/o aches x 36hr;									Y	10/04/1999	10/04/1999	0		OTH	PVT	Beconase & allegra PRN allergies	NONE	NONE	NA~ ()~~~In patient		1						1	Myalgia	FLU3~CONNAUGHT LABORATORIES~U0067AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129959	10/26/1999	CA	39.0	39		M	10/12/1999	c/o body aches, fatigue, fever x48hr;									Y	09/30/1999	09/30/1999	0		OTH	PVT		NONE	NONE	NA~ ()~~~In patient		1						1	Asthenia; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0067AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129960	10/26/1999	CA	65.0	65		F	10/25/1999	arm itching, swelling all over arm-red, & hot to touch w/pain w/increasing intensity;rx APAP & ASA & ice packs;inner arm bright red now yellow still tender to touch;									N	10/01/1999	10/01/1999	0	NONE	PVT	PVT				~ ()~~~In patient		1						1	Oedema peripheral; Pain; Pruritus; Skin discolouration; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0129961	10/26/1999	TX	47.0	47		F	10/25/1999	fever, h/a, w/severe stiff neck;									Y	01/22/1999	10/22/1999	273	NONE	OTH	PUB	Lovox;prozac;	NONE	Brain Disorder-obsessive comp disorder	~ ()~~~In patient		1						1	Headache; Nuchal rigidity; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0129962	10/26/1999	IN	42.0	42		F	10/25/1999	extreme dizziness about 3 days post vax nausea, bad h/a, body hot then cold;slept x 36hr;									N	10/20/1999	10/23/1999	3	NONE	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Chills; Dizziness; Headache; Nausea; Somnolence; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0129963	10/26/1999	MA	62.0	62		F	10/22/1999	6hr post vax pt exp mild muscular ache in leg w/sl temp;									Y	10/21/1999	10/21/1999	0	NONE	PUB	PUB	clariten	NONE	unk allergies	~ ()~~~In patient		1						1	Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0129964	10/26/1999	TX	37.0	37		F	10/22/1999	approx 4hr post vax dental appt became feverish, hot p/vax;pt dizzy, chills, h/a, hoarse;									Y	10/21/1999	10/21/1999	0	NONE	OTH	PUB	TB skin test;Advil	NONE	NONE	~ ()~~~In patient		1						1	Chills; Dizziness; Dysphonia; Headache; Pyrexia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0129965	10/26/1999	IL	42.0	42		F	10/23/1999	T102, sore arm-red & raised, nausea, h/a-little trouble breathing when temp was elevated (arm given pneumo);									Y	10/20/1999	10/21/1999	1	NONE	PUB	PUB	NONE	NONE	PCN allergy	~ ()~~~In patient	IL99070	1						1	Dyspnoea; Myalgia; Nausea; Pyrexia; Rash maculo-papular; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0129967	10/26/1999	MA	37.0	37		M	10/24/1999	achy, pain in rt arm increased sweating profusely;rx given;T101.4;rash on rt arm from inj 1/2 down arm to elbow x 2 days;									N	10/21/1999	10/22/1999	1	NONE	OTH	PUB				~ ()~~~In patient		1						1	Hyperhidrosis; Injection site hypersensitivity; Myalgia; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0129968	10/26/1999	CO	72.0	71		F	10/24/1999	dizzy 30hr post vax hip & spine pain;could barely walk;could not focus properly;extremely tired could not get out of be x 2 days;eyes are still sensitive;unconscious for 12 hrs & in & out of consciousness for the entire day & following nigh										10/21/1999	10/22/1999	1	NONE	OTH	OTH	NONE	NONE	hip bursitis	pt esp swollen arm w/Td~ ()~~~In patient		1						1	Amblyopia; Arthralgia; Asthenia; Back pain; Coma; Dizziness; Hypokinesia; Visual disturbance; Amblyopia; Osteoporosis; Stupor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~PARKDALE PHARMACEUTICALS~02979P~2~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0129969	10/26/1999	OH	53.0	53		F	10/21/1999	cold, clammy, felt faint;wanted to lie down;unable to get BP;epi given;rescue called;palpated BP 88/-;refused transfer;pt stated always feels like will pass out w/any shot;										10/21/1999	10/21/1999	0		OTH	PUB			dust	~ ()~~~In patient		1						1	Chills; Hyperhidrosis; Malaise	FLU3~CONNAUGHT LABORATORIES~U0150AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129970	10/26/1999	CA	51.0	51		M	10/21/1999	p/vax pt having tingling down arm to fingers tips;										10/08/1999	10/08/1999	0		UNK	UNK			NONE	~ ()~~~In patient		1						1	Paraesthesia; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~U0132AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~PFIZER\WYETH~U0132AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0129971	10/26/1999	MI	41.0	41		F	10/13/1999	w/in 10min of vax pt started w/cough & diff breathing;pt given DPh;pt then had sore throat & laryngitis lasting approx 4hr;pt described burning pain down arm;									Y	10/05/1999	10/05/1999	0	NA	PVT	PVT	Lotensin	NONE	HTN	~ ()~~~In patient		1						1	Cough; Dyspnoea; Laryngitis; Pain; Pharyngitis	FLU3~PFIZER\WYETH~4998231~7+~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129973	10/26/1999	WI	54.0	54		F	10/18/1999	3-4 days p/vax pt c/o itchy rash covering area on 2-3inch diameter in area where shot given;denies pain swelling, or any other sx;									U	10/13/1999	10/16/1999	3		PUB	UNK		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus	FLU3~PARKDALE PHARMACEUTICALS~02089P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1402H~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0124906	10/27/1999	IN	57.0	57		F	10/19/1999	pt c/o fever, h/a, arm soreness; MD observed;									Y	09/26/1998	09/27/1998	1		UNK	UNK		NIDDM, HTN, hx anxiety disorder	NKDA	~ ()~~~In patient		1						3	Asthenia; Headache; Pain; Pyrexia; Tremor; Asthenia; Headache; Pyrexia; Tremor; Headache; Myalgia; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~20178HB~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~~1~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~~1~~~PNEUMO (PNEUMOVAX)~2|FLU3~MEDEVA PHARMA, LTD.~E20178HB~UNK~~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~3|PPV~UNKNOWN MANUFACTURER~1095H~UNK~~LL~PNEUMO (NO BRAND NAME)~3	USA		Influenza
0127945	10/27/1999	IN	49.0	49		F	10/14/1999	fever 104, coughing, soreness @ inj site;MD observed;had pneumonia 8/98 tx by MD;									Y	09/24/1998	10/01/1998	7		PVT	PVT	Taxol;Carbiplatin	sm cell lung adenocarcinoma;UTi	keflex, PCN, steroids	~ ()~~~In patient		1						2	Cough; Pyrexia; Respiratory disorder; Cough; Injection site pain; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E20178HB~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~454976~1~~RA~PNEUMO (PNU-IMUNE)~1|FLU3~MEDEVA PHARMA, LTD.~E20178HB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~PFIZER\WYETH~454976~UNK~IM~RA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0129975	10/27/1999	NY	42.0	42		F	10/27/1999	flare up of SLE, swelling of joints of both upper & lower limbs, dec mobility of joints d/t pain;					Y				Y	10/22/1999	10/22/1999	0	ESR-30;C3, C4, C10-WNL	PVT	UNK			SLE, DM, HTN, osteoporosis	NONE~ ()~~~In patient		1						1	Arthralgia; Arthritis; Condition aggravated; Hypokinesia; Red blood cell sedimentation rate increased; Systemic lupus erythematosus	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0129977	10/27/1999	WI	27.0	27		F	10/21/1999	diffuse, urticaria epi, DPH, pred, fluids given;				Y					Y	10/14/1999	10/14/1999	0	NONE	PVT	OTH	Orthotricyclene BCP	NONE	PCN allergy	~ ()~~~In patient		1						1	Urticaria	FLU3~PFIZER\WYETH~4998229~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0129978	10/27/1999	TN	57.0	57		F	10/21/1999	arm swelling, pain redness, chills MD prescribed dicloxacillin;				Y					Y	10/15/1999	10/15/1999	0		UNK	UNK				~ ()~~~In patient		1						1	Chills; Generalised oedema; Pain; Rash	FLU3~PFIZER\WYETH~4998218~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0129982	10/27/1999	MS	48.0	48		F	10/20/1999	10x5cm swelling, hot, itching rxn at site of inj;									Y	10/18/1999	10/19/1999	1	NONE	PVT	PVT	Antihypertension med;	NONE	HTN	~ ()~~~In patient		1						1	Injection site oedema; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4998284~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129986	10/27/1999	IN	42.0	42		F	10/14/1999	p/vax inj site red, swollen, sore rt deltoid;MD observed;									Y	10/05/1999	10/07/1999	2		PVT	PVT	Synthroid;PPD by Connaught lot# 248811 given 10/5/99;	hypothyroidism;	generic synthroid	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~02779P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~458743~UNK~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0129987	10/27/1999	CA	19.0	19		F	10/12/1999	approx 3-5min p/vax c/o feeling light-headed color pale, pulse 112/bounding-placed on floor;feeling better p/5min;then severe nausea w/retching c/o feeling hot, color dusky, c/o diff breathing-911 lightheaded when sitting/standing-nausea										10/12/1999	10/12/1999	0	pulse 112/min;dec 96/min;BP 112/72;110/80;	OTH	PVT	NONE	recovering from cold	NONE	~ ()~~~In patient		1						1	Dizziness; Dyspnoea; Pallor; Tachycardia; Vasodilatation; Vomiting	FLU3~PFIZER\WYETH~4998242~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0125165	10/28/1999	TN	74.0	74		F	10/26/1999	p/vax pt could not swallow & was having silent aspirations of large proportions;w/in a month could not walk;dx w/auto immune mediated motor neuron degeneration;pt had had numerous hosp many ICU;blood transfusions;plasma exchange, IVIG, pred Follow-up: numerous subsequent episodes of aspiration and bacterial pneumonia. THERE WAS NO PRIOR HISTORY OF OR PREDISPOSITION TOWARDS THESE EVENTS PRIOR TO THAT FLU SHOT. As you known my many previous reports, mother's condition continued to disable and eventually kill her. It is now clear to me from your web site that she had GUILLAIN-BARRE syndrome (GBS) resulting from that flu shot on Oct 24, 1997 and continued to deteriorate until her death on Dec. 24, 2002. If any one has been or is compensated in this matter, make sure that I am notified immediately.					Y				N	10/24/1997	11/01/1997	8		UNK	UNK	Feosol-ferrous sulfate, folic acid-vit b complex, Oscal-calcium, K-DUR=potassiu, Vitamin E, Woman's vitamin, prevacid, lasix, pred, synthroid, premarin, coumadin, xanax				U199900753	1						2	Asthenia; Bone disorder; Dysphagia; Hypokinesia; Myasthenic syndrome; Myopathy; Osteonecrosis; Respiratory disorder; Speech disorder; Abasia; Aspiration; Autoimmune disorder; Blood product transfusion; Death; Disability; Dysphagia; Guillain-Barre syndrome; Haemolytic anaemia; Intensive care; Neuropathy; Pneumonia bacterial; Respiratory disorder; Transfusion; Affect lability; Bronchitis; Dysphagia; Haemolytic anaemia; Hypokinesia; Immune system disorder; Myasthenic syndrome; Neuropathy; Osteonecrosis; Respiratory disorder; Thinking abnormal	FLU3~PFIZER\WYETH~7F81829~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~CONNAUGHT LABORATORIES~7F81829~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~7F81829~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Hospitalisation	Influenza
0129932	10/28/1999	MI	33.0	33		F	10/14/1999	low grade fever 2-3 days;on lt arm only-pain, significant rash 9area 8x15cm) x 5 days;urticaria;tx w/DPH & hydrocortisone cream entire upper arm markedly swollen for 4 days;									Y	10/09/1999	10/09/1999	0	NONE	OTH	PVT		NONE		~ ()~~~In patient		1						1	Oedema peripheral; Pain; Pyrexia; Rash; Urticaria	FLU3~PFIZER\WYETH~~5~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~1~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0129970	10/28/1999	CA	51.0	51		M	10/21/1999	p/vax pt started having tingling down arm to fingers tips;seen again on 10/18/99;exam was negative;EKG was negative;pt was still having sx less;										10/08/1999				UNK	UNK			NONE	~ ()~~~In patient		1						2	Paraesthesia; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~U0132AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~PFIZER\WYETH~U0132AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0129991	10/28/1999	FL	55.0	55		F	10/27/1999	p/vax pt was found dead;it it unk if an autopsy is being performed;	Y	10/20/1999							N	10/19/1999	10/20/1999	1		UNK	UNK	insulin, Pepcid	none x/ feeling tired	IDDM, poorly controlled; Arteriosclerotic disease w/ angina; elev cholesterol; frequent URI & UTI; diverticulitis; hiatal hernia; breast CA s/p lumpectomy in '92-in remission	None~ ()~~~In patient	U199900765	1						1	Apnoea; Cardiac arrest; Myocardial infarction	FLU3~CONNAUGHT LABORATORIES~U0096BA~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0129993	10/28/1999	ND	44.0	44		F	10/19/1999	p/vax pt devel severe pruritus;had hives @ inj site-now generalized;recv DPH, solumedrol & resp therapy tx as devel  SOB p/arrived in ER; adm to ICU;Annual follow-up dated 11/22/00 provided no additional data.			Y	Y	Y					10/19/1999	10/19/1999	0	CBC-%neutrophils=45.7;chem 7-BUN=6;10/21/99 WBC 22.00;neut% 91.7; lymp 6.5;	PUB	PVT	Flonase;Aerobid;Serovent;Claritin;Proventil;Verapamil;	NONE	multiple (70+) found et environmental allergies;no allergic to eggs;			1						1	Asthma; Dyspnoea; Hypersensitivity; Injection site hypersensitivity; Leukocytosis; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4998217~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0130000	10/28/1999	TX	85.0	85		F	10/22/1999	p/vax pt presented to clinic w/localized rxn to rt upper arm;approx 2 1/2cm in diameter w/induration & erythema;no open areas or other complaints;tx ice, allegra;to return to clinic if sx worsen or do not improve;				Y					U	10/19/1999	10/22/1999	3	NONE	PUB	OTH	Pepcid, Levot, KDur, Lasix, Risperdal, buspar, Lanoxin	no acute illness	tetracycline, PCN, mycins, regland, decadron,medrol, inderal	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4998244~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0130004	10/28/1999	IL	32.0	32		F	10/25/1997	p/vax pt devel aches & pains in hands & legs then all over;constant pain saw MD 12/97;ANA test positive sent to rheumatologist;saw MD 1/98 tx for joint inflammation;started having problems w/eyes;recurring episcleritis;still under MD care;				Y					N	10/01/1997	10/04/1997	3	blood test negative;x-rays-nl;	UNK	UNK		healthy	healthy	~ ()~~~In patient		1						1	Antinuclear antibody; Arthritis; Eye disorder; Myalgia; Pain; Scleritis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0130005	10/28/1999	CA	58.0	58		F	10/25/1999	p/vax pt noticed tenderness & redness @ site;pt to employee hlth w/60mm induration, cool to touch;sent for eval by MD;				Y					Y	10/22/1999	10/23/1999	1		PVT	PUB		local 60mm induration	similar rxn to estrogen inj;	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~MEDEVA PHARMA, LTD.~E33609KA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~E33609KA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0130007	10/28/1999	KY	17.0	17		F	10/13/1999	p/vax pt devel sz;pt had prev hx of sz & taking med for sz;									Y	10/11/1999	10/13/1999	2		PUB	PUB	Depacote;Lamical	sz under control	nocturnal sz since age 8mo	~ ()~~~In patient	KY990045	1						1	Condition aggravated; Convulsion	FLU3~CONNAUGHT LABORATORIES~U0065AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130010	10/28/1999	IL	36.0	35		M	10/26/1999	p/vax pt devel a lot of pain 10/22/99 @ inj site;states pain subsided 10/23 but returned 10/24 & then severe throughout upper arm w/a sensation of rawness under arm;									U	10/21/1999	10/22/1999	1		PUB	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site pain	FLU3~CONNAUGHT LABORATORIES~U0126FA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130012	10/28/1999	MD	10.0	10		M	10/22/1999	had fever 102 for about 24-48hr & felt tired;pt had had the flu vax for several years a/this year;									Y	10/12/1999	10/13/1999	1	NONE	PUB	PUB	NONE	NONE		NONE~ ()~~~In patient		1						1	Asthenia; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~02979P~4~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130013	10/28/1999	MD	5.0	5		M	10/22/1999	fever 102 day p/vax;also had some vomiting;still c/o earache;MD did not feel this was vaccine related did given ATB & feeling better;									Y	10/12/1999	10/13/1999	1	throat culture	OTH	PUB	NONE			NONE~ ()~~~In patient		1						1	Ear pain; Pyrexia; Vomiting	FLU3~PARKDALE PHARMACEUTICALS~02979P~3~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130014	10/28/1999	NY	45.0			F	10/25/1999	p/vax pt devel chills & fever 101.5 for 48hr achy & chills Friday 10/22/99 felt OK;									Y					PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Chills; Myalgia; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130015	10/28/1999	VA	30.0	30		F	10/20/1999	p/vax pt devel 4inch diameter bruising, couldn't lift arm, flu sx, fever, body ache, couldn't breath felt like throat was closing up;felt like someone had split pelvic bone;pneumonia vax given same day arm very tender, couldn't be left;									Y	10/13/1999	10/13/1999	0	NA	PVT	PVT	Flovent, Singular	NONE	claritin-rash;tetracycline-rash;contrast dye-hives;	NA~ ()~~~In patient		1						1	Asthenia; Dyspnoea; Ecchymosis; Hypokinesia; Influenza; Laryngospasm; Myalgia; Pain; Pyrexia	FLU3~PFIZER\WYETH~4998284~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1693H~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0130016	10/28/1999	VA	25.0	25		F	10/25/1999	1 1/2 x 1 rash @  site of inj w/itching & pain & knot;rash gone by 10/25/99 7AM;pain & itching still present;									Y	10/22/1999	10/23/1999	1		PUB	UNK		NONE	latex allergy, seasonal allergy	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Pruritus	FLU3~PARKDALE PHARMACEUTICALS~02089P~7+~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130026	10/29/1999	MN	2.0	2	.3	M	10/25/1999	nephrotic synd devel w/in 6wk of vax;			Y					Y	N	11/02/1998	11/15/1998	13	urine protein >2000 on dip UA;BUN 34, Cr 0.5;NA 127;Cl 92;Platelets 675K;albumin2.1;C3 260.6, C4 91.2, Hgb 9.7;BUN/Cr ratio 110;	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Albuminuria; Anaemia; Blood urea increased; Hypochloraemia; Hyponatraemia; Hypoproteinaemia; Laboratory test abnormal; Nephrotic syndrome; Thrombocythaemia	FLU3~CONNAUGHT LABORATORIES~0980530~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Disabling	Influenza
0130027	10/29/1999	IN	40.0	40		F	10/25/1999	p/vax pt devel extreme agitated depression, necessitating hosp;discharged 10/14/99;intermittent agitation & depression through 10/17/99;					Y	1			Y	10/07/1999	10/13/1999	6	normal thyroid, chemistry panel, CBC;therapeutic Tofranil level;	PVT	PVT	Tofranil;Cylert	mild depression	chronic depression onset 1982, hosp just once prev, in 7/98;			1						1	Agitation; Condition aggravated; Depression	FLU3~CONNAUGHT LABORATORIES~U0132AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0130028	10/29/1999	CA	81.0	81		M	10/22/1999	pt recv vax @ clinic 10/21/99 & deceased @ home 10/22/99;	Y	10/22/1999							N	10/21/1999	10/22/1999	1		OTH	PUB	ProAmatine, Cozaar, Dyazide; Pepcid, Carafate, Albutrol;	NONE	NKDA;CHF, COPD	unk~ ()~~~In patient		1						1	Cardiac arrest; Coronary artery disease; Hypertension; Lung disorder; Right ventricular failure	FLU3~PFIZER\WYETH~4998221~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0130029	10/29/1999	MI	28.0	28		F	10/22/1999	p/vax that evening felt lt armpit tender & swollen;no swelling, tenderness, redness @ site;upon exam no obvious localized or mult adenopathies;c/o tenderness w/palpation & sensation of enlargement;				Y					U	10/13/1999	10/13/1999	0	NONE	PVT	PVT	Daypro;Flexeril;Darvocet;Anaprox;	NONE	lt sacroilitis;Lumbar Radiculopathy	~ ()~~~In patient		1						1	Lymphadenopathy; Oedema; Pain	FLU3~CONNAUGHT LABORATORIES~U0066FA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0130030	10/29/1999	NY	22.0	22		M	10/27/1999	itchy eyes, flushed, ears red 4hr p/vax;				Y					Y	10/25/1999	10/25/1999	0	NONE	PVT	PVT	NONE	NONE	allergic to cat hair;	NA~ ()~~~In patient		1						1	Ear disorder; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4998274~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0130032	10/29/1999	CA	34.0	34		F	10/08/1999	c/o pain & redness & swelling on  rt upper arm w/size of 15cm x 2mm;				Y					Y	10/03/1999	10/06/1999	3		OTH	OTH				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~E24249GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0130033	10/29/1999	IL	51.0	51		F	10/26/1999	fast heart beat, difficulty breathing;				Y					Y	10/20/1999	10/20/1999	0		PUB	PUB	NONE	NONE	all seafood;	~ ()~~~In patient		1						1	Dyspnoea; Tachycardia	FLU3~PARKDALE PHARMACEUTICALS~02679P~2~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0130035	10/29/1999	MO	26.0	26		F	10/21/1999	approx 30min p/vax pt exp rapid heart rate, feeling funny not right, throat feeling funny;pt sent to ER & released;				Y					Y	10/20/1999	10/20/1999	0	unk	OTH	PVT	unk	NONE	NONE	~ ()~~~In patient		1						1	Laryngospasm; Malaise; Tachycardia	FLU3~CONNAUGHT LABORATORIES~U0104AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0130037	10/29/1999	CA	76.0	76		M	10/04/1999	pt went to bed rt arm aching;APAP given;T99.5 (97 normal), swelling started @ distal deltoid muscle to below elbow;inc swelling, redness & hot to touch;called MD to pack w/ice;went to MD c/o rx given too low;red, hot to touch, mild swelling				Y					Y	10/01/1999	10/01/1999	0	NONE	PUB	PUB	NONE	NONE	sulfa	~ ()~~~In patient	CA990116	1						1	Injection site hypersensitivity; Injection site oedema; Myalgia; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~W4998216~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0870H~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0130038	10/29/1999	MI	68.0	67		F	10/13/1999	p/vax pt started itching & by that evening swelling & redness @ inj site;lt arm above 5-6in above elbow;next AM dark bruising @ inj site;swelling, redness, itching spread around arm;burning , itching, swelling on lt arm;				Y					Y	10/04/1999	10/04/1999	0	NA	PUB	PUB	Atenol, Plavix, Lanoxion	NONE	PCN & erythromycin-hives, itching-No SOB, heart blockage, hyperglyc	~ ()~~~In patient	MI99095	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema; Oedema peripheral; Pain; Pruritus	FLU3~PARKDALE PHARMACEUTICALS~02089P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~70871H~1~SC~LA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~7358AB~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0130040	10/29/1999	MI	65.0	65		F	10/15/1999	pt/vax swelling & redness & itching from inj site & about 3 inches down, on lt arm upper;it was hot to the touch for couple days;MD instructed pt to take DPH & to monitor temp;				Y					Y	10/05/1999	10/12/1999	7	NONE	PUB	PUB	ASA	NA	allergy to IVP dye	NA~ ()~~~In patient	MI99097	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02089P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~0871H~1~SC~RA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~7358AB~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0130041	10/29/1999	MI	61.0	61		F	10/14/1999	hives (12) each 10 to 20mm diameter;erythematous;locations: arms, legs, abd;				Y						10/12/1999	10/13/1999	1		PUB	UNK	Celebrex, Glucosamine	nONE	hx of sensitive skin-itches;had shingles in 1992 or 94;	~ ()~~~In patient	MI99099	1						1	Rash; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~0289P~4~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0130049	10/29/1999	OR	44.0	44		F	10/25/1999	red & swollen arm;large area for >24hr;ER notified & employee started on heat packs;									Y	10/22/1999	10/22/1999	0		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4998230~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130051	10/29/1999	MI	58.0	58		M	10/25/1999	extreme hoarseness;loss of taste;loss of smell;pain armpit lt arm;nasal & chest congestion;									N	10/18/1999	10/19/1999	1	NONE	OTH	OTH	Lopid;Flovent-allegra	NONE	timothy hay;asthma;high cholesterol	~ ()~~~In patient		1						1	Ageusia; Dysphonia; Lung disorder; Lymphadenopathy; Parosmia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~4998231~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130053	10/29/1999	ME	76.0	75		F	10/25/1999	generalized rash, dizziness;									N	10/22/1999	10/24/1999	2		PVT	PVT	Synthroid;cozaar	NONE	PCN, sulfa, tylox	~ ()~~~In patient		1						1	Dizziness; Rash	FLU3~CONNAUGHT LABORATORIES~U0118AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130057	10/29/1999	MD	56.0	56		F	10/25/1999	soreness lt arm;no noted edema;T97.8;BP 122/60;APAP given;referred to PMD tomorrow;									U	10/20/1999				OTH	OTH	?BP meds;?antiole ped	NONE		pt devel hives @ age 21 w/tetanus;~ ()~~~In patient		1						1	Pain	FLU3~PFIZER\WYETH~4998344~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130058	10/29/1999	MD	48.0	48		F	10/25/1999	pt exp lightheadedness approx 1 1/2hr p/vax;intermittent  x 1 1/2-2hr then stopped;									Y	10/25/1999	10/25/1999	0	NONE	OTH	UNK	Tenormin	NONE	dust, molds, cats, latex, codeine, cipro	NONE~ ()~~~In patient		1						1	Dizziness	FLU3~PFIZER\WYETH~4998243~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130065	10/29/1999	CA	47.0	47		F	10/22/1999	fever, chills, presented to hosp ER-care given transferred to another hosp;									U	10/21/1999	10/21/1999	0	NONE	OTH	PUB	Librium	NONE	allergic to PCN	unk~ ()~~~In patient		1						1	Pyrexia	FLU3~PFIZER\WYETH~4998221~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130066	10/29/1999	OH	49.0	49		F	10/25/1999	p/vax upper arm red, swollen, hot & tender;T101 saw MD;AM & started on Zithromax;sx improved & fever gone;dx cellulitis of inj site;										10/19/1999	10/20/1999	1		PUB	PUB	NONE	NONE	pt reports allergy to PCN & sulfa, not to eggs;	NONE~ ()~~~In patient	OH99080	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~U0136AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130067	10/29/1999	NY	14.0	14		F	10/25/1999	pt c/o throat tightness & SOB tx @ ER;2 days later c/o chest pain;									N	10/20/1999	10/20/1999	0	CBC;	PVT	PVT	NONE	NONE	RAD	NONE~ ()~~~In patient		1						1	Chest pain; Dyspnoea; Laryngospasm; Pleural disorder	FLU3~CONNAUGHT LABORATORIES~U0156AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130068	10/29/1999	MA	73.0	73		F	10/26/1999	p/vax pt began w/chills, weakness into Thursday PM;took extra strength advil w/juice;10/25/99 just starting to feel better & lt the house;									Y	10/20/1999	10/20/1999	0	NONE	PUB	UNK		NONE	HTN, NKDA	~ ()~~~In patient		1						1	Asthenia; Chills	FLU3~CONNAUGHT LABORATORIES~U017AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130070	10/29/1999	LA	64.0	63		F		Itch w/hot feeling in rt arm;little swollen on rt arm, but redness & little pain;warm compress to rt arm area & take APAP tablets for pain;										10/18/1999	10/22/1999	4		PUB	OTH	Hormone Tablets;BP Pressure & ASA	NONE	NONE	~ ()~~~In patient	LA991005	1						1	Oedema peripheral; Pain; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0129AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~LEDERLE LABORATORIES~465315~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0130078	11/01/1999	CA	72.0	71		F	10/08/1999	p/vax pt noted redness, swelling & itching around inj site;also c/o nausea, h/a & feeling feverish & took 2 ASA for discomfort;then became diaphoretic, dizzy, tingling of both arms, shaky & weak;taken to hosp ER given DPH & ATB;disch 10/8				Y	Y	2			Y	10/06/1999	10/06/1999	0		PUB	PUB	Dilacol, HPTN;	NONE	HTN & allergies;Claritin allergy	NONE~ ()~~~In patient	CA990117	1						1	Asthenia; Dizziness; Headache; Hyperhidrosis; Injection site hypersensitivity; Injection site oedema; Nausea; Paraesthesia; Pruritus; Pyrexia; Tremor	FLU3~MEDEVA PHARMA, LTD.~E26919HA~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0870H~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0130092	11/01/1999	PA	49.0	49		M	10/20/1999	erythema, edema to rt inner arm (upper), down to elbow;tx DPH;ice to arm;				Y					Y	10/19/1999	10/19/1999	0	NONE	PUB	PUB	Synthroid;DPH; BENADRYL	NONE	thyroid, diverticulitis, NKDA	NA~ ()~~0.00~Patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4998279~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1573A~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0130094	11/01/1999	NH	62.0	62		U	10/25/1999	severe swelling from elbow to neck & erythema;resolved over 5 days;				Y					Y	10/20/1999	10/20/1999	0		PVT	PVT	HCTZ;Nitro;Toprol;Glucotrol;		CAD, HTN	~ ()~~~In patient		1						1	Lymphadenopathy; Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~U0148AB~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~463721~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0130095	11/01/1999	LA	48.0	48		M	10/26/1999	pt began having muscle aches a/vax;had been very run down & fatigue p/vax;sore throat & swollen glands;chills, temp up to 104;saw MD temp to 105;Keflex;temp between 98/6-102;throat still sore;				Y					U	10/18/1999	10/21/1999	3	NONE	OTH	PUB	No meds;	NA	NONE	NA~ ()~~~In patient		1						1	Lymphadenopathy; Myalgia; Pharyngitis; Pyrexia	FLU3~PFIZER\WYETH~4998238~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0130098	11/01/1999	CA	71.0	71		F	10/15/1999	pt recv vax & devel redness, swelling & heat (no drainage) below inj site;				Y					U	10/13/1999	10/14/1999	1	NONE	OTH	OTH	Synthroid	NONe	thyroid	~ ()~~~In patient		1						1	Injection site abscess; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E30879KA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~459041A~1~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0130099	11/01/1999	IL	20.0	20		F	10/21/1999	area @ pneumovax site became swollen & inflamed the day p/vax;saw MD;pt placed on ATB;saw pt again 10/20/99 & was feeling better;pt had 12-15cm ecchymotic area surrounding site;				Y					Y	10/15/1999	10/16/1999	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	IL99066	1						1	Ecchymosis; Injection site hypersensitivity; Injection site inflammation; Injection site oedema	FLU3~MEDEVA PHARMA, LTD.~E26779HA~UNK~A~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1402H~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0130100	11/01/1999	NV	49.0			M	10/18/1999	woke up w/pain on rt side trunk under rt arm, rt bad tenderness, rt groin pain, lumbar pain;2 ASA in PM helped;rt sided pain less severe today;									Y	10/15/1999	10/16/1999	1		PUB	PVT		NONE		~ ()~~~In patient	NV99014	1						1	Abdominal pain; Lymphadenopathy; Pain	FLU3~PARKDALE PHARMACEUTICALS~02779P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~454384~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0130101	11/01/1999	WY	74.0	74		F	10/22/1999	p/vax pt lt arm started hurting/in 30 swelling, redness, inc skin temp;unable to sleep last noc secondary to pain;				Y					Y	10/21/1999	10/21/1999	0		PUB	PUB		NONE		~ ()~~~In patient	WY9914	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Insomnia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0132AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~459837~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0130102	11/01/1999	WY	18.0	18		F	10/27/1999	p/vax pt broke out in itchy macular rash on arms, legs, trunk of body;reported rxn to public hlth on 10/27/99;advised DPH & avoiding vaccines containing chicken protein;									N	10/25/1999	10/26/1999	1	NONE	PUB	PUB	Claritan	NONE	NONE			1						1	Pruritus; Rash maculo-papular	FLU3~PFIZER\WYETH~4998209~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~459837~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0130104	11/01/1999	MO	54.0	54		F	10/12/1999	p/vax pt called ER & was vomiting, had diarrhea & had hard red-raised area, size of a silver dollar, on arm where vax given;redness @ inj site;									Y	10/09/1999	10/09/1999	0	NONE	PUB	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Diarrhoea; Injection site hypersensitivity; Injection site mass; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0129AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130105	11/01/1999	MO	26.0	26		F	10/22/1999	p/vax pt noticed red spot around the inj site the size of silver dollar it was hot to touch & swollen;called ER MD;took DPH;									Y	10/19/1999	10/19/1999	0	NONE	OTH	PVT	NONE	NA		~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0129AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130106	11/01/1999	TX	39.0	38		F	10/26/1999	face-beet red-tops of hands red & along hair line of both arms;									Y	10/25/1999	10/25/1999	0	NA	OTH	OTH	NA	NONE	NONE			1						1	Vasodilatation	FLU3~PFIZER\WYETH~4998211~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130107	11/01/1999	CA	41.0	41		F	10/18/1999	p/vax pt reported fever 103-10 hr p/vax;shaking chills x24hr then nausea x 2 days;no c/o diarrhea, runny nose, cough;									U	10/12/1999	10/12/1999	0		PVT	PVT	NONE	NONE	shellfish & iodine			1						1	Chills; Pyrexia; Tremor; Vomiting	FLU3~PARKDALE PHARMACEUTICALS~4099G010~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130108	11/01/1999	CT	80.0	80		F	10/25/1999	24hr p/vax c/o generalized itching all over body, hand itching, a flushed face & generalized flushing;took APAP;did not call MD;									U	10/19/1999	10/20/1999	1	NONE	PUB	PUB	unk	unk	unk		CT9910	1						1	Pruritus; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E243096A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0130109	11/01/1999	WI	43.0	43		F		p/vax pt noticed 5 circle of redness, firmness & warmth on upper lt deltoid area;some tenderness when touched;tx w/cold packs to affected area & APAP alternating w/advil;redness, warmth & firmness cont;									Y	10/05/1999	10/06/1999	1	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~U0094AA~6~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130111	11/01/1999	CA	66.0	66		F	10/26/1999	woke from sleep groaning & churning about in bed the noc of day of vax;generally miserable;T100.0;									Y	10/15/1999	10/16/1999	1		PUB	UNK	Estrogen, vitamins	NONE	NONE	NONE~ ()~~~In patient		1						1	Agitation; Insomnia; Malaise; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~7+~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0130113	11/01/1999	AR	77.0	77		F		severe muscular tightness upper arms/neck, back, chest;called MD;sx lessened by end of wk x/for chest;still aches & have SOB;chest tightness;									N	10/11/1999	10/11/1999	0		PVT	UNK	Lipitor;toprol;lexoyl;Bayer ASA;		elevated cholesterol	NONE~ ()~~~In patient		1						1	Chest pain; Dyspnoea; Hypertonia; Myalgia	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130114	11/01/1999	TN				U		p/vax pt had red, warm area upper arm @ inj site;arm OK;no further sx;									Y	10/20/1998	10/21/1999	366		PVT	UNK		NONE	NOE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PFIZER\WYETH~4998293~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130115	11/01/1999	GA	23.0	23		M	10/13/1999	devel hives to body especially chest & back w/itching;saw MD & suggested getting flu shot @ MD office next yr;									Y	10/07/1999	10/11/1999	4	NONE	PUB	PUB	Tegretol	sz, MR	MR	NA~ ()~~~In patient	GA99136	1						1	Pruritus; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1402H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0130116	11/01/1999	GA	82.0	82		F	10/13/1999	pt had fever 102 & bodyaches;in bed x 2 days;had flu vax 10/5/99;									Y	10/05/1999	10/06/1999	1	NA	PUB	PUB	unk	unk	NKA	NA~ ()~~~In patient		1						1	Myalgia; Pyrexia; Myalgia; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~02979P~7+~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~02979P~7+~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0130117	11/01/1999	GA	88.0	88		M	10/13/1999	fever 102 & bodyaches;MD gave meds for sx;in bed x 2 days;									Y	10/05/1999	10/06/1999	1	NA	PUB	PUB	unk	unk	unk	NA~ ()~~~In patient	GA99138	1						1	Myalgia; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~02979P~7+~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130120	11/01/1999	PA	69.0	69		F	10/21/1999	p/vax pt c/o n/v, pain in arm from elbow to shoulder;stated unable to lift arm;pt instructed to call family MD;called 24hr later & pain greatly decreased & other sx subsided;arm pain was localized;									Y	10/19/1999	10/19/1999	0		PUB	PUB	Lithobid;Premarin;Synthroid	NONE	Arthritis;hypothyroidism;pneumonia last year	NA~ ()~~0.00~Patient		1						1	Hypokinesia; Injection site pain; Vomiting	FLU3~PARKDALE PHARMACEUTICALS~01959P~1~IM~UN~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1573H~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0130121	11/01/1999	VA	75.0	75		F	10/28/1999	rt deltoid red, swollen to anterior shoulder & painful followed by itching;									Y	10/21/1999	10/22/1999	1	NONE	PVT	PVT	Provera;Dilocor;synthroid;Dyazide;Premarin;Cardura;Clontin;	NONE	allergic to dorvon, codeine, tetanus, naprosyn;HTN, DA, GERD, skin CA	pt exp red, swollen, painful lt arm @ age 73 w/tetanus~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0094A~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1584H~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0130122	11/01/1999	MS	61.0	61		F	10/26/1999	pt c/o redness & soreness w/some itching to rt deltoid;denies any fever;pt is able to move arm well;instructed to take APAP or motrin & apply warm to cool compress;									Y	10/25/1999	10/26/1999	1		OTH	UNK		NONE	NONE	~ ()~~~In patient	MS99047	1						1	Injection site hypersensitivity; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~4998232~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130124	11/01/1999	IA	43.0	43		M	10/22/1999	red swollen upper arm from armpit t elbow, itches. first noticed 10/19/99 while at work. suggested call MD office.										10/18/1999	10/19/1999	1	NONE	UNK	UNK	unk	NONE	NKA		IA99032	1						1	Injection site hypersensitivity; Injection site oedema; Lymphadenopathy; Pruritus	FLU3~PFIZER\WYETH~4998263~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130126	11/01/1999	MD	55.0	55		F	10/26/1999	local rxn @ site, red, warm, swollen, SOB;DPH given;									Y	10/25/1999	10/25/1999	0		OTH	PVT	NONE	nONE	sulfa drugs;	~ ()~~~In patient		1						1	Dyspnoea; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4998224~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130127	11/01/1999	NC	54.0	54		F	10/12/1999	started to have pain & severe soreness approx 1 1/2hr p/vax;by 5PM arm felt heavy & painful to lift;erythema & swollen lt deltoid involving entire upper arm by 730PM;ice applied;									Y	10/11/1999	10/11/1999	0		PUB	PUB	NONE	NONE	allergic PCN azithromycin, Novicaine/sensitive-epinephrine	~ ()~~~In patient	SC99065	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Myasthenic syndrome; Pain	FLU3~CONNAUGHT LABORATORIES~V0131AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1095H~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0130128	11/01/1999	CA	58.0	58		F		p/vax pt achy, bones & muscles (in back, across shoulders & middle) cramp, cold chills, nausea, T101-102;nothing to eat x 2 days;arm inj site very sore 7 warm to touch;advil did not completely relieve sx;will see PMD if sx are not better;									U	10/06/1999	10/17/1999	11	NONE	PUB	PUB		NONE	NONE	NONE~ ()~~~In patient	CA990119	1						1	Anorexia; Back pain; Chills; Hypertonia; Injection site hypersensitivity; Injection site pain; Myalgia; Nausea; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4998216~2~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130130	11/01/1999	CO	20.0	19		M	10/25/1999	diarrhea x 4 days p/vax;s/sx began 1 day p/vax;no tx required;									Y	10/20/1999			NONE	PUB	PUB		NONE	NA	~ ()~~~In patient		1						1	Diarrhoea	FLU3~CONNAUGHT LABORATORIES~U0066CA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130131	11/01/1999	MA	59.0	59		F	10/28/1999	4-8 red rxn on rt arm  got pneumovax twice in 1yr by different hlth care provider;;									Y	10/26/1999	10/27/1999	1		PUB	PUB		NONE	NONE	~ ()~~~In patient	MA9919	1						1	Injection site hypersensitivity	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0129722	11/02/1999	KY	41.0	41		F	10/21/1999	evening p/vax pain-1 day later edema & redness;itching;										10/19/1999	10/19/1999	0		PUB	PUB	Prozac;Prevacid	NONE	Tofrinil	~ ()~~~In patient	KY990044	1						2	Oedema; Pain; Pruritus; Vasodilatation; Oedema; Pain; Pruritus; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02979P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~02979P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0130136	11/02/1999	MI	6.0	6		M	10/25/1999	high fever w/gen sz for approx 30min or more;this happened about 30hr p/vax;			Y	Y	Y	2			Y	10/13/1999	10/14/1999	1	blood, CSF exam, cultures were negative;	PVT	UNK		cerebral palsy, developmental delay	tracheo cutaneous fistula s/p tracheostomy closure; per discharge diagnosis: mental retardation, cerebral palsy, RAD			1						1	Febrile convulsion	DTAP~PFIZER\WYETH~464300~4~IM~RL~DTAP (ACEL-IMUNE)~1|FLU3~CONNAUGHT LABORATORIES~0983290~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SMITHKLINE BEECHAM~2944A2~UNK~IM~LL~HEP B (ENGERIX-B)~1|IPV~CONNAUGHT LTD.~N1062~1~IM~LL~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0920J~2~IM~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0424J~UNK~IM~LL~VARICELLA (VARIVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0130137	11/02/1999	WV	2.0	2	.2	M	10/28/1999	2hr p/vax pt devel fever;has S. pneumoniae bacteremia & sinusitis;					Y	5			Y	10/22/1999	10/22/1999	0	CBC;blood culture-pos for strep pneumo (PCN resistant);Head CT-nl; urine cx-neg; LP-neg	PVT	PVT	Albuterol;Cromolyn		reactive airway disease	NONE~ ()~~~In patient		1						1	Pyrexia; Sepsis; Sinusitis	FLU3~PFIZER\WYETH~4998225~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0130139	11/02/1999	MN	23.0	23		F	10/20/1999	dizziness, flushing, swelling in head & face, SOB, lower abd pain cramping;DPH & epi given w/relief of sx;			Y						Y	10/20/1999	10/20/1999	0		PVT	OTH	NONE	NONE	allergy-sulfa	NONE~ ()~~~In patient		1						1	Abdominal pain; Dizziness; Dyspnoea; Face oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0132AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~466443~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening	Influenza
0130151	11/02/1999	OK	20.0			U		pt came into clinic 10/22/99 & had a swollen upper lip;given solumedrol which resolved problem;									Y					UNK	UNK				~ ()~~~In patient		1						1	Face oedema	FLU3~CONNAUGHT LABORATORIES~U0108EA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130154	11/02/1999	WY	40.0	40		F	10/27/1999	fever & chills;rash w/itching;used DPh & lanocaine, had welts disappeared & then came back;to MD dx hives taking Clariton using Aveeno lotion, DPH gel;				Y					Y	10/19/1999	10/19/1999	0		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	WY9916	1						1	Pyrexia; Rash; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0130156	11/02/1999	IL	29.0	29		M	10/22/1999	p/vax pt devel fever & red @ inj site lt deltoid;lt arm cellulitis;cellulitis resolved but cont w/mild intermittent myalgia & intermittent sweats;probable serum sickness;				Y					Y	09/17/1999	09/17/1999	0	NONE	OTH	PVT	NONE	NONE	disc disease, no birth defects, no allergies;	NONE~ ()~~~In patient		1						1	Cellulitis; Hyperhidrosis; Injection site hypersensitivity; Injection site mass; Myalgia; Pyrexia; Serum sickness	FLU3~CONNAUGHT LABORATORIES~U0096EA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1291H~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0130157	11/02/1999	SC	67.0	67		F	10/27/1999	rt arm red from shoulder to elbow, inflamed & itching for several days-felt bad-visited walk-in clinic;urgent care of hosp;prescribed pred-1wk;				Y					Y	10/12/1999	10/13/1999	1		PUB	UNK	DPH, APAP, pepcid, premarin;	NONE	allergies, fibromyalgia;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site inflammation; Malaise; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0130160	11/02/1999	NC	78.0	78		M		p/vax swelling began on upper arm;swelling had reached to near wrist;swelling was quite severe;went to ER;recommended ice packs & massage & elevation;swelling less gradually over 2 days;told to use DPH;				Y					Y	10/09/1999	10/09/1999	0	unk	PVT	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site oedema; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~463772~UNK~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0130163	11/02/1999	MI	35.0	35		M		p/vax broke out w/rash, palms, feet, leg, abd;legs & arms swollen;saw MD;tx w/antihistamine, ATB;no improvement saw MD again;tx mega pak ATB;no improvement now red & stretched;tongue sensitive, finger tips sore;				Y						10/06/1999	10/07/1999	1		PVT	PUB	Diprolene;remeran;	NONE	asthma	NONE~ ()~~~In patient		1						1	Oedema peripheral; Pain; Rash; Tongue disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0130166	11/02/1999	WA	0.7	0	.7	F	10/25/1999	p/vax pt devel rash;BP 122/80, T95.0;given DPH;				Y					Y	10/21/1999	10/21/1999	0	NA	PVT	PVT	Tricycline	rash approx 12 long x 4 wide	NONE	~ ()~~~In patient		1						1	Hypertension; Hypothermia; Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~U0109BA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0130169	11/02/1999	UT	67.0	67		F	10/14/1999	p/vax pt arm swollen up 3PM;the next day arm began to be blotchy w/many red sore areas;				Y					Y	10/11/1999	10/11/1999	0	NONE	PUB	PUB		NONE	asthma, allergies to motrin, cigarette smoke, HPT	NONE~ ()~~~In patient	UT992733	1						1	Oedema peripheral; Pain; Rash	FLU3~PARKDALE PHARMACEUTICALS~4099G010~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1611H~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0130170	11/02/1999	OH	21.0	21		F	10/29/1999	sudden onset of near-syncope & severe lethargy w/ 1 1/2hr;BP 150/104, monitor;to ER via amb;				Y					U	10/29/1999	10/29/1999	0		OTH	PVT	kit supplement	NONE	frequent PVC	~ ()~~~In patient		1						1	Dizziness; Somnolence	FLU3~CONNAUGHT LABORATORIES~U0136AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0130171	11/02/1999	IN	42.0	42		F	10/22/1999	p/vax pt having spasms on lt arm;up in the middle of noc w/spasm;described as tightness throughout lt arm;pain & soreness w/spasm;dx local rxn & med prescribed;				Y					N	10/13/1999	10/15/1999	2	no test	PUB	PUB		NONE	anemic & low white count-has high epstein Barr count	NONE~ ()~~~In patient	IN99034	1						1	Hypertonia; Injection site reaction; Oedema peripheral; Pain	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~CONNAUGHT LABORATORIES~7302BA~7+~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0130175	11/02/1999	VT	0.3	0	.3	M	10/19/1999	5hr p/vax pt to MD office;has been crying since vax;remarkably tender, site rxn, erythema, pain in rt leg;				Y					Y	10/19/1999	10/19/1999	0	NONE	PVT	PUB	Digixon;Lasix;	NONE	pre-mature, heart conditon;aeortic stenosis	NONE~ ()~~~In patient	VT99004	1						1	Injection site hypersensitivity; Injection site pain	DTAP~SMITHKLINE BEECHAM~911A1~2~IM~RL~DTAP (INFANRIX)~1|FLU3~PFIZER\WYETH~4998225~1~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HIBV~PFIZER\WYETH~P1113AA~2~IM~LL~HIB (HIBTITER)~1|IPV~CONNAUGHT LTD.~N08262~2~SC~LL~POLIO VIRUS, INACT. (POLIOVAX)~1	USA	Emergency room visit	Influenza
0130176	11/02/1999	PA	44.0			F	10/27/1999	T101, aches, congestion, sore arms, fatigue-small erythematous area on both arms @ sites of inj;sx worsened T103 rt inj site redness & induration;				Y					Y	10/25/1999	10/28/1999	3	NA	UNK	UNK	Inderal;Neurontin;Risperdal;Prn Ativan for behavior;	NONE	mental retardation	NONE~ ()~~0.00~In Patient	PA9974	1						1	Asthenia; Injection site hypersensitivity; Injection site mass; Myalgia; Pharyngitis; Pyrexia; Rhinitis	FLU3~PFIZER\WYETH~4998279~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1402H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0130177	11/02/1999	ND	36.0	36		F	10/26/1999	p/vax pt had strange taste in mouth;noted a lot of mucus in throat;uncontrollable cough;couldn't swallow fast enough;taken to ER;shoulders hurt;heart palpitations;felt anxious;IV DPH given-released on DPH q 8hr x 2 days;				Y					Y	10/20/1999	10/20/1999	0	BP checked;	PUB	PUB	NONE	mononucleouses x 3wk	mononucleouses  x 3wk;	NA~ ()~~~In patient	MN99019	1						1	Anxiety; Cough; Dysgeusia; Dysphagia; Myalgia; Palpitations; Salivary hypersecretion	FLU3~PFIZER\WYETH~4998290~3~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0130182	11/02/1999	MA				F	10/21/1999	felt lightheaded, woozy-color bright pink-face & extremities;HR elevated 110, BP 190's (was 136/70 a/vax); mouth felt dry-tongue swollen sl;									Y				NONE	OTH	UNK		NONE	allergic: sulpaa, bee sting (hypersensitive response to anti-histamines;	~ ()~~~In patient		1						1	Dizziness; Dry mouth; Hypertension; Tachycardia; Tongue oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0107AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130185	11/02/1999	CA	46.0	46		F	10/29/1999	approx 4 1/2hr p/vax pt got chills which escalated into numbness of fingers & toes w/excessive, shaking throughout body inside & out;(very unnerving & painful);heated temp, sweats & chills & aching;T102;									Y	10/26/1999	10/26/1999	0	NA	OTH	OTH	NONE	sl congestion	NONE	NONE~ ()~~~In patient		1						1	Chills; Myalgia; Nervousness; Pain; Paraesthesia; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130186	11/02/1999	NE	43.0	43		F	10/27/1999	felt faint, laid down;BP 54/42, water & cookie given;watched & monitored until BP 102/76;vasovagal synd rxn;pt hungry, rushed & stressed;									Y	10/13/1999	10/13/1999	0	NONE	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Dizziness; Hypotension; Nervousness; Syncope	FLU3~CONNAUGHT LABORATORIES~U0095AA~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130187	11/02/1999	WA	47.0	47		F	10/27/1999	about 20 p/vax pt noticed swelling of fingers & hands & red rash on neck;given DPH;itchy;sl joint swelling;									Y	10/22/1999	10/22/1999	0	NONE	PVT	PVT	Pred,hchlorogaine, Progestrone, Estrogen, antriptylie;	NONE		pt exp joint pain @ age 46 w/hep b vax #2;~ ()~~~In patient		1						1	Oedema peripheral; Osteoarthritis; Pruritus	FLU3~PFIZER\WYETH~4998244~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130188	11/02/1999	PA	34.0	34		M	10/30/1999	severe diff breathing, constriction of chest;lasted approx 24hr & sx decreased when antihistamine was taken;									Y	10/19/1999	10/19/1999	0	NONE	OTH	OTH	low dose ASA dialy & propecia	NONE	childhood PCN allergy	~ ()~~~In patient		1						1	Chest pain; Dyspnoea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130191	11/02/1999	NY	52.0	52		F	10/28/1999	p/vax pt inj site began to swell immed to size of golf ball;w/in a few min ice was applied;MD checked pt c/o not feeling well, dizziness, lips tingling;BP 130/140/80-90, P72;									Y	10/27/1990	10/27/1999	3287		PVT	UNK	Monopril	NONE	PCN, Lodine, fish, shellish, HTN	~ ()~~~In patient		1						1	Dizziness; Hypertension; Injection site mass; Injection site oedema; Malaise; Paraesthesia	FLU3~PFIZER\WYETH~4998283~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130192	11/02/1999	KS	68.0	68		F	10/18/1999	chills @ 1st noc;chills am & noc 2nd noc;sore throat & runny nose;									Y	10/16/1999	10/16/1999	0	NONE	PUB	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Chills; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~U0132AA~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130194	11/02/1999	KS	75.0	75		F	10/20/1999	next day p/vax tired, malaise;sx still occurring 5 days later tired, malaise;									Y	10/15/1999	10/15/1999	0	NONE	PUB	PVT	Norvasc;Lasix;Serax;	NONE	HTN	NONE~ ()~~~In patient		1						1	Asthenia; Malaise	FLU3~PFIZER\WYETH~U0132AA~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130195	11/02/1999	KS	60.0	60		M	10/24/1999	sx started 10/24/99 h/a, cough, diarrhea, muscle aches;no fever;									U	10/16/1999	10/24/1999	8	NONE	PUB	PVT	Avipro;Lithobid	NONE	asthma, hayfever, HTN	NONE~ ()~~~In patient		1						1	Cough; Diarrhoea; Headache; Myalgia	FLU3~CONNAUGHT LABORATORIES~U0132AA~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130196	11/02/1999	MO	38.0	38		M	10/28/1999	fever, spot on arm turned red & warm;									U	10/26/1999	10/28/1999	2	NONE	PUB	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0132AA~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130197	11/02/1999	CA				F	10/28/1999	severe hives lasting 10 days;									Y	10/12/1999	10/12/1999	0		PUB	PUB		NONE	NONE	~ ()~~~In patient		1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130198	11/02/1999	WI	39.0	39		F	10/22/1999	p/vax pt lt upper arm @ inj site red, firm & itchy;no resp distress, no hives;T97.8;advised to alternate advil w/APAP;hydrocortisone cream applied to inj area to dec pruritus;redness resolved;									Y	10/05/1999	10/08/1999	3	NONE	OTH	PVT	Slobid, Alegra, Proventil, Asthma med?name	NONE	dust, pollne;no birth defects;hx asthma;	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0094AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130199	11/02/1999	MI	45.0			F	10/26/1999	arm greatly discolored (purple black);size of silver dollar w/hard care in middle (size of a quarter);disorientated;improved orientation;discoloration persist;									Y	10/21/1999	10/22/1999	1	NONE	PUB	UNK		NONE		NONE~ ()~~~In patient		1						1	Confusional state; Ecchymosis; Skin discolouration; Skin nodule	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130200	11/02/1999	OR	34.0	34		F	10/26/1999	arm was sore & swollen;became very sleepy & sx lasted 36hr;									Y	10/20/1999	10/20/1999	0	NONE	PVT	PVT	vit	NONE		pt exp nausea & arm pain w/flu vax;~ ()~~~In patient		1						1	Oedema peripheral; Pain; Somnolence	FLU3~CONNAUGHT LABORATORIES~U0096EA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130201	11/02/1999	NE	47.0	47		F	10/27/1999	arm swelled & sore;rx Allegra x 10 days;MD felt shot given too low;									Y	10/13/1999	10/14/1999	1	NONE	OTH	OTH			NONE	NONE~ ()~~~In patient		1						1	Oedema peripheral; Pain	FLU3~CONNAUGHT LABORATORIES~U0150AA~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130203	11/02/1999	IL	79.0	78		F	10/27/1999	p/vax pt felt like airway was closing, couldn't breathe;put ice on throat, had immed relief;									Y	10/26/1999	10/26/1999	0		OTH	PUB		NONE	NONE	NA~ ()~~~In patient		1						1	Apnoea	FLU3~PFIZER\WYETH~4998214~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130204	11/02/1999	NE	44.0	44		F	10/27/1999	localized red, swollen, sore, feverish for 2 days & PCP;warm pads & DPH;									Y	10/12/1999	10/12/1999	0		OTH	OTH	NONE			NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia	FLU3~PFIZER\WYETH~U0152AA~7+~A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130205	11/02/1999	NE	46.0	46		F	10/27/1999	quarter size redness/warm to touch,pain immed & golf ball size;									Y	10/12/1999	10/12/1999	0		OTH	OTH		NONE	allergies & asthma	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~U0095AA~1~A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130206	11/02/1999	NE	24.0	24		F	10/27/1999	localized red, swollen, sore, feverish;went to student hlth recv claritan & Ibuprofen & ok in 5-7 days;									Y	10/12/1999	10/12/1999	0		OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~60118AA~7+~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130207	11/02/1999	NE	34.0	34		F	10/27/1999	shot swelled like big mosquito bite arm sore, swelled & feverish 3-4 days;									Y	10/12/1999	10/12/1999	0	NONE	OTH	OTH	NONE	NONE	allergies;	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~60118AA~7+~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130208	11/02/1999	VA	31.0	31		F	10/29/1999	approx 20min p/vax arm started to feel numb;upper arm tender to touch, equal bilat hand grasps, pain w/ROM in lt arm;no  notable edema or redness @ site of inj;									U	10/28/1999	10/28/1999	0	NA	OTH	OTH		NONE	NONE	~ ()~~~In patient		1						1	Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~U0118AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130209	11/02/1999	WY	45.0	45		F	10/28/1999	p/vax pt became dizzy & fell-no injuries;pt was flushed & felt very weak in upper body;sx lasted until 930PM;no sx next day;saw MD ;									Y	10/22/1999	10/22/1999	0		PUB	PUB	Tegretol;K-dur, Depo Provera, Zantac, lasix;	NONE	blind, depression, mood swings, edema	~ ()~~~In patient	WY9915	1						1	Dizziness; Injury; Myasthenic syndrome; Vasodilatation; Dizziness; Myasthenic syndrome; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U01328A~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~459837~1~IM~RA~PNEUMO (PNU-IMUNE)~1|FLU3~CONNAUGHT LABORATORIES~U01328A~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~459837~1~IM~RA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0130212	11/02/1999	TN	26.0	26		F	10/18/1999	pt devel hives on face, neck & chest approx 90min p/vax;hives cleared in less than 60min p/DPH;									Y	10/14/1999	10/14/1999	0	NONE	PUB	OTH	Paxil;Birth Control Pill	NONE	NONE	NA~ ()~~~In patient		1						1	Urticaria	FLU3~PFIZER\WYETH~4998263~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130215	11/02/1999	OR	49.0	48		F	10/22/1999	tingling lips, swelling hands, sl flushed, dizzy, lightheaded, migraine area, memory loss, chest tight, wheezing, felt hot;DPH;EPI;									Y	10/22/1999	10/22/1999	0	BP 140/70;	OTH	PVT	NONE	cough once a day	prmature born w/o epiglottis, coma, spinal meningitis, migraine;	NONE~ ()~~~In patient		1						1	Amnesia; Asthma; Chest pain; Condition aggravated; Dizziness; Migraine; Oedema peripheral; Paraesthesia oral; Vasodilatation; Visual disturbance	FLU3~PFIZER\WYETH~4998238~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130216	11/02/1999	MA	58.0	58		F	10/26/1999	p/vax pt called in sick to work c/o rxn to flu shot;c/o lump in rt arm pit (?swollen gland) & uncontrollable nausea, vomiting & diarrhea which suddenly began on morning of 10/18/99;told to call MD;									Y	10/14/1999	10/18/1999	4	NONE	OTH	PVT	NONE	NONE		pt exp rxn in 1962 w/flu vax;~ ()~~~In patient		1						1	Diarrhoea; Lymphadenopathy; Malaise; Vomiting	FLU3~PFIZER\WYETH~4998221~3~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130217	11/02/1999	FL	37.0	36		M	10/29/1999	p/vax pt c/o purpura-like rash this AM on rt hand & arm;no rash on rt upper arm or @ inj site-rash onset 10/27/99;									U	10/28/1999	10/29/1999	1	PT, PTT, CBC, Coag Profile ordered 10/29;	PUB	OTH	BC powder 10/28	NONE	NKA;no birth defects;no med condition	NONE~ ()~~~In patient		1						1	Purpura	FLU3~PFIZER\WYETH~4998245~4~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130220	11/02/1999	CA	58.0	58		F	11/02/1999	area w/generalized swelling w/some tenderness;not red, not hot;it taking Ibuprofen;declines medical eval;hx of some erythema p/PPD;									Y	11/01/1999	11/01/1999	0	NA	PVT	PVT	Verpamil;Premarin;Maxide;Ibuprofen;	NONE		~ ()~~~In patient		1						1	Oedema; Pain	FLU3~PFIZER\WYETH~4998230~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130221	11/02/1999	OH	42.0	42		F	10/27/1999	sudden onset on intense pain & soreness @ site w/in 2hr;by evening pain was to the point of tears;paralyzed;									Y	10/22/1999	10/22/1999	0	unk	OTH	PVT	chemotherapy	NONE	lung cancer	~ ()~~~In patient		1						1	Injection site pain; Paralysis	FLU3~CONNAUGHT LABORATORIES~U0136AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130222	11/02/1999	NC	55.0	55		F	10/08/1999	p/vax pt throat was scratchy & hoarse;w/in about 5min stated breathing felt tight & some wheezes;color pallor;tx w/epi & given DPH;										10/06/1999	10/06/1999	0		UNK	UNK			HTN, bad aortic valve;	~ ()~~~In patient		1						1	Asthma; Chest pain; Dysphonia; Dyspnoea; Pallor; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~U0128CA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130223	11/02/1999	PA	64.0	64		F	10/27/1999	p/vax lt arm was swollen, warm, reddened & hard to touch;c/o limited mobility & pain upon movement;									Y	10/25/1999	10/25/1999	0	NONE	UNK	UNK	Prandin;Zocor;prevacid;Humulin N;	NONE	IDDM, high chol	NONE~ ()~~0.00~Patient	PA9975	1						1	Hypokinesia; Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4998279~6~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1716H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0130224	11/02/1999	CA	51.0	51		F	10/21/1999	p/vax pt face red c/o itching on palms & feet;vitals 97.9, BP 160/80, P92, R20;mild itching;pain @ inj site, diarrhea;flu like sx;									Y	10/17/1999	10/17/1999	0	NA	OTH	PVT	Entex;Vioxx	congestion	allergy-ampicillin	~ ()~~~In patient		1						1	Diarrhoea; Hypertension; Hypothermia; Influenza; Injection site pain; Pruritus; Tachycardia; Vasodilatation	FLU3~PFIZER\WYETH~4998275~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130225	11/02/1999	MO	48.0	48		F	10/22/1999	eyes-burning, itching, watering, eyelids some swelling;throat c/o tightening et felt like it closing;rash-chest;some redness & swelling @ site;took DPH;seen by MD;									Y	10/18/1999	10/18/1999	0	NONE	OTH	PVT	oral contraceptive	NONE	NONE	NONE~ ()~~~In patient		1						1	Eye pain; Face oedema; Injection site hypersensitivity; Injection site oedema; Lacrimal disorder; Laryngospasm; Pruritus; Rash	FLU3~PFIZER\WYETH~U0155AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130227	11/02/1999	DC	56.0	56		M	10/27/1999	flu sx, sensitivity to light & sound;upper resp congestion, spikes in temp;chills, myalgias, fatigue, rt h/a;										10/18/1999	10/20/1999	2		OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Dizziness; Hyperacusis; Influenza; Pharyngitis; Photosensitivity reaction; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130228	11/02/1999	MA				F		p/vax pt devel nasal stuffiness w/in 2hr;congestion & localized rxn;										10/14/1999	10/14/1999	0	NONE	UNK	UNK			allergies: PCN, NSAIDS-angioedema/conjunctivas edema;	~ ()~~~In patient		1						1	Injection site reaction; Rhinitis	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130230	11/02/1999	MI	1.0	1	.0	M	10/27/1999	wrong dose was given 0.5ml should have been 0.25ml;										10/26/1999				PVT	PVT	NONE	NONE	hx of prematurity, BPD	~ ()~~~In patient		1						1	Unevaluable event	FLU3~PARKDALE PHARMACEUTICALS~02879P~UNK~~RL~INFLUENZA (SEASONAL) (FLUOGEN)~1|IPV~CONNAUGHT LTD.~P05522~4~~LL~POLIO VIRUS, INACT. (POLIOVAX)~1	USA		Influenza
0130231	11/02/1999	MI	1.0	1	.0	F	10/27/1999	wrong dose was given  0.5ml it should have been 0.25ml;										10/26/1999				PVT	PVT	Bactrim	NONE	hx of prematurity, BPD	~ ()~~~In patient		1						1	Unevaluable event	FLU3~PARKDALE PHARMACEUTICALS~02879P~UNK~~RL~INFLUENZA (SEASONAL) (FLUOGEN)~1|IPV~CONNAUGHT LTD.~P05522~4~~LL~POLIO VIRUS, INACT. (POLIOVAX)~1	USA		Influenza
0130232	11/02/1999	MI	1.0	1	.0	F	10/27/1999	wrong dose given 0.5ml it should have been 0.25ml;										10/26/1999				PVT	PVT	NONE	NONE	hx of prematurity, BPD	~ ()~~~In patient		1						1	Unevaluable event; Anaemia; Haematuria; Premature labour	FLU3~PARKDALE PHARMACEUTICALS~02879P~UNK~~RL~INFLUENZA (SEASONAL) (FLUOGEN)~1|IPV~CONNAUGHT LTD.~P05522~4~~LL~POLIO VIRUS, INACT. (POLIOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~2	USA		Influenza
0130237	11/03/1999	MA	62.0	62		F	10/26/1999	less than 24hr post vax pt arm became swollen, red & hard-area 6 in diameter;rx ice sx increased dx possible cellulitis;after several days sx resolved;				Y					Y	10/16/1999	10/17/1999	1	NONE	PVT	OTH	Hydrochlorothiazide;Zestril	NONe	some antibiotics 7 various environmental	~ ()~~~In patient		1						1	Cellulitis; Oedema peripheral; Skin nodule; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0130239	11/03/1999	NY	19.0	19		F	10/27/1999	localized inflammatory rxn or rt tricep area extending down to elbow;erythematous lesion elevated, hard & red;				Y					U	10/25/1999	10/25/1999	0	NONE	PVT	PVT	could not (?) understand	NONE	congenital Tetralogy of fallot	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site inflammation; Injection site mass	FLU3~CONNAUGHT LABORATORIES~U0134BA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454386~UNK~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0130240	11/03/1999	CA	65.0	65		F	10/27/1999	rash began around inj site-proceeded to travel down arm-across abd to rt arm;tiny pinprick rash spread over entire body bright red diffused w/litter separation;rapid breathing;fever, n, muscle aches, rapid pulse, loss appetite;				Y						10/19/1999	10/20/1999	1	sed 20, inc lymph	UNK	UNK				~ ()~~~In patient		1						1	Anorexia; Hyperventilation; Myalgia; Nausea; Pyrexia; Rash; Tachycardia	FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0130245	11/03/1999	GA	71.0	71		M	10/28/1999	body rash, intense itching on hands, under arms & groin-MD tx w/cortisone;resolved over several days;				Y					Y	10/18/1999	10/22/1999	4	NONE	PUB	PUB	Zantac;Tentiloff	NONE		~ ()~~~In patient	GA99144	1						1	Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0130246	11/03/1999	AZ	59.0	59		F	10/30/1999	n/v, diarrhea for sometime;dehydrated & transported to hosp by paramedic;				Y					Y	10/24/1999	10/24/1999	0	EKG, Blood work;monitored Bp	OTH	PUB	Progesteron;Estrogen	NONE	NONE	~ ()~~~In patient		1						1	Dehydration; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0130248	11/03/1999	CA	20.0	20		F	10/29/1999	15min post vax lt hand swelled & became red & hot;36hr later face swelled including eyes & mouth;48-50hr breathing became more difficult;				Y					Y	10/25/1999	10/25/1999	0	BP 145/105;	OTH	PUB	Allegra;Ibuprofen;Nordetton	NONE	NONE	~ ()~~~In patient		1						1	Dyspnoea; Face oedema; Hypertension; Oedema peripheral; Rash; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0130249	11/03/1999	NJ	50.0	50		F	10/29/1999	raised 3 to 4 circular inflammation @ inj site;hot to touch w/pain-knee & hip became red & painful-knee filled w/fluid;				Y					N	10/18/1999	10/19/1999	1	bloodwork-no results as yet;	PVT	OTH	Minerals;multi-vitamins;premarin	NONE	NONE	pt exp mild site rxn @ age 49 w/flu vax;~ ()~~~In patient		1						1	Arthralgia; Injection site inflammation; Injection site mass; Injection site pain; Osteoarthritis; Vasodilatation	FLU3~PFIZER\WYETH~4998251~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0130250	11/03/1999	CA	29.0	29		F	10/29/1999	T100;severe muscle aches w/sore throat;				Y					N	10/28/1999	10/28/1999	0	NONE	PVT	PVT	Phenobarbital;Lamictal	NONE	sz disorder, asthma;	~ ()~~~In patient		1						1	Myalgia; Pharyngitis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0130251	11/03/1999	IA	55.0	55		F	10/26/1999	flushed face, hot, excessive full chest feeling, diff breathing, bad h/a, muscle/joint pain;fast heart beat;runny nose;chills, pain,pressure in head/behind eyes;tiredness, exhaustion;weakness;			Y						N	10/22/1999	10/23/1999	1	NONE	PVT	OTH	Potassium;Diuretic;methazide loop;	NONE	pulmonary problems (asthma);			1						1	Arthralgia; Asthenia; Chest pain; Chills; Dyspnoea; Headache; Myalgia; Rhinitis; Tachycardia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0130252	11/03/1999	OR	51.0	51		F	10/26/1999	24hr post vax pt devel soreness & redness @ site;poss temp;2x3cm spot on arm;sore & tender to touch;rxn treated for cellulitis;warm compress;				Y					Y	10/22/1999	10/23/1999	1	NONE	PVT	PVT	Levoxsil;Premarin;Prozac;Provara;	NONE	talingectasia;	~ ()~~~In patient		1						1	Cellulitis; Injection site hypersensitivity; Injection site pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0127AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~~UNK~~LA~HEP B (RECOMBIVAX HB)~1|PPV~MERCK & CO. INC.~~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0130254	11/03/1999	AK	25.0	25		F	11/02/1999	redness @ inj site w/in 7hr w/swelling resolved;24hr later devel red mac pap rash under eyes & few scattered lesions on extrem w/itching;				Y						10/30/1999	10/30/1999	0	NONE	OTH	OTH	Calamine;BC Pill;Paxil	NONE	sulfa, amoxycillin, pollen	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Rash maculo-papular	FLU3~PFIZER\WYETH~4998233~7+~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0130259	11/03/1999	IL	36.0	36		F	10/26/1999	p/vax pt began w/SOB w/feeling that throat was swelling shut;then noticed arm began swelling from shoulder to elbow became red et hard @ very warm to touch;loss of appetite, fever, diarrhea, sore & swollen throat, loss of voice;to MD;				Y					Y	10/20/1999	10/20/1999	0	NONE	PUB	PVT		NONE	spinal disorder from injury, asthma;	pt exp rxn @ age 31 w/flu vax dose 1;~ ()~~~In patient	IL99067	1						1	Anorexia; Diarrhoea; Dysphonia; Dyspnoea; Injection site hypersensitivity; Injection site oedema; Laryngospasm; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0063AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~458746~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0130261	11/03/1999	MO	49.0	48		F	10/22/1999	pt reports racing heart, weakness, dizziness & chills lasting 4hr;pt reports recv shot @ ER which relieved sx;				Y					Y	10/19/1999				PUB	PUB	NONE	NONE		unk~ ()~~~In patient	MO99043	1						1	Asthenia; Chills; Dizziness; Tachycardia	FLU3~PARKDALE PHARMACEUTICALS~02679P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0130265	11/03/1999	NC	47.0	46		F	10/26/1999	pt exp generalized itching w/o rash;devel redness on chest w/itching;devel red, pinpoint rash w/itching on thighs, abd, chest, neck;tx w/DPH rash/itching resolved x/residual to neck;									Y	10/18/1999	10/19/1999	1	NA	PVT	PVT	Tieac, Synthroid	NONE	NONE	~ ()~~~In patient		1						1	Pruritus; Rash	FLU3~PFIZER\WYETH~4998217~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130266	11/03/1999	OH	61.0	61		F	10/27/1999	p/vax 1 1/2hr later eyes became bloodshot & started hurting;exp bodyaches & a sore throat & could hardly swallow;									Y	10/26/1999	10/26/1999	0	NONE	OTH	PVT	NONE	NONE	unk	~ ()~~~In patient		1						1	Conjunctivitis; Dysphagia; Myalgia; Pain; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~U0136AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130267	11/03/1999	OH	53.0	53		F	11/02/1999	p/vax draining clear & redness in both eyes;chills, cough, congestion w/yellow;heat @ inj site;redness, swelling @ inj site;									Y	10/07/1999	10/08/1999	1	NONE	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Chills; Conjunctivitis; Cough; Injection site hypersensitivity; Injection site oedema; Lacrimal disorder; Rhinitis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0136AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130269	11/03/1999	TX	51.0	51		M	10/28/1999	lip tissue & under tongue-had swelling;itching in back of throat;excess amount of drainage;									Y	10/26/1999	10/26/1999	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Face oedema; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0130272	11/03/1999	IN	74.0	74		F	11/01/1999	rawness on lt leg;raised, whelps, burning;pt applied an anti-itch cream & applied tissue-pain;describes as hives;									N	10/30/1999	10/31/1999	1	NONe	OTH	OTH						1						1	Pain; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130273	11/03/1999	UT	63.0	63		F	11/01/1999	pt exp extreme tiredness-lost voice, pounding h/a, stuffed up head & sinus-no voice x 4 days;									Y	10/19/1999	10/21/1999	2	NONE	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Dysphonia; Headache; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130274	11/03/1999	CA	51.0	51		F	11/01/1999	arm started hurting, aches pain, severe backache;temp elevated;flu sx;arm swollen;could not move arm;rash x 2 days;sx resolved x 3 days;									Y	10/22/1999	10/22/1999	0	NONE	PVT	PVT	Flagyl;Mebaline HCL;Laintex;Premarin	sinus infect	NONE	~ ()~~~In patient		1						1	Back pain; Hypokinesia; Influenza; Myalgia; Oedema peripheral; Pain; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0130275	11/03/1999	WA	46.0	46		F	10/30/1999	severe vomiting 9 hr post vax;									N	10/29/1999	10/30/1999	1	NONE	PVT	OTH	oxcodone;methadone	NONE	chronic pain;	~ ()~~~In patient		1						1	Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130276	11/03/1999	CA	43.0	43		F	10/28/1999	stomach pains, nausea, vomiting persisted for more than 24hr-accompanied by chills, fever & diarrhea-resp sx began w/sore throat, general malaise & myalgias;									Y	10/23/1999	10/23/1999	0	NONE	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Abdominal pain; Chills; Diarrhoea; Nausea; Pharyngitis; Pyrexia; Rhinitis; Vomiting	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130277	11/03/1999	TX	76.0	76		F	11/02/1999	tightness in throat & under jaw, h/a, very weak x 3 days-fast heart beat;BP 163/89, P109, dizzy called MD office;									Y	10/22/1999	10/22/1999	0	NONE	OTH	OTH	Calan;Pred;Bathotrecksate;other heart needs;	NONE	arrythmia, arthritis, asthma	~ ()~~~In patient		1						1	Asthenia; Dizziness; Headache; Hypertension; Laryngospasm; Tachycardia	FLUX~UNKNOWN MANUFACTURER~~3~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130278	11/03/1999	CA	33.0	33		F	11/01/1999	p/vax sx described as label-behavior change, diff breath, hoarseness, rash, weakness, low energy, fast heart beat;									Y	10/22/1999	10/29/1999	7	NONE	PVT	PVT	NONE	nONE	PCn, bee stings;	~ ()~~~In patient		1						1	Asthenia; Dysphonia; Dyspnoea; Personality disorder; Rash; Tachycardia	FLUX~UNKNOWN MANUFACTURER~~3~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130279	11/03/1999	CO	72.0	72		M	10/27/1999	vertigo clearing p/4-5 days;									Y	10/21/1999	10/22/1999	1	gram only	PVT	UNK			Meniegs/severe sn agarwl luss	~ ()~~~In patient		1						1	Vertigo	FLU3~CONNAUGHT LABORATORIES~U0159AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129467	11/04/1999	MD	74.0	74		M	10/15/1999	p/vax pt began to have tremors of upper torso, over heart area;pt transported to hosp via amb;				Y					Y	10/14/1999	10/14/1999	0	EKG-nl;blood tests-nl;	PUB	UNK	Cortison;baby ASA	NONE	hx heart disease, prostate & bladder CA per daughter	NA~ ()~~~In patient	MD99023	1						3	Palpitations; Tremor	FLU3~PARKDALE PHARMACEUTICALS~02979P~7+~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~3	USA	Emergency room visit	Influenza
0130282	11/04/1999	CA	26.0	26		F	11/03/1999	diffuse body urticaria;generalized erythema;cardiac palpations, temp, hot flashes;			Y	Y					Y	10/28/1999	10/28/1999	0	NONE	PVT	OTH	Calcium;synthroid;Dexidrine	NONE	hypothyrodism, Macrodantin allergy;			1						1	Palpitations; Pyrexia; Rash; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0128AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0130284	11/04/1999	CA	49.0	49		M	11/03/1999	working in backyard when exp sudden onset of low back pain, to ER walking w/o problems but devel lower extremity paralysis acutely; Annual follow-up received on 12/13/2000 provided no additional data.				Y	Y				U	10/11/1999	10/30/1999	19	LP, MRI, EKG, CT scan of brain w/o contrast, CXR, CT of pelvis, abd, lumbar spine;	OTH	PVT	NONE	NONE	allergy:  tetanus??; potential esophagitis			1						1	Back pain; Hypercholesterolaemia; Leukocytosis; Myelitis; Paralysis; Back pain; Paralysis; Back pain; Paralysis	FLU3~CONNAUGHT LABORATORIES~U0109CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0109CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLUX~UNKNOWN MANUFACTURER~U0109CA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Hospitalisation	Influenza
0130290	11/04/1999	OH	22.0	22		F	11/03/1999	c/o pain & numbness in whole lt arm 9arm where inj given) the day p/vax;				Y					U	10/29/1999	10/30/1999	1	NONE	PVT	UNK	Zoloft;Orthocept	had bronchites 10day prior	PCN-hive;sulfa-itchy;	~ ()~~~In patient		1						1	Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~00103AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0130295	11/04/1999	NY	20.0	20		M		p/vax that evening felt itchy & congested;by evening facial swelling & redness;tx w/pred & zyrtec;				Y					Y	10/25/1999	10/25/1999	0		OTH	OTH	NONE	NONE	psoriasis	~ ()~~~In patient		1						1	Face oedema; Pruritus; Rhinitis; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0130297	11/04/1999	WV	68.0	68		F	11/01/1999	p/vax pt c/o swelling in arm to the wrist & pain in the underarm;									Y	10/29/1999	10/29/1999	0		PUB	UNK		had rt side storke in past	allergic to demeral	~ ()~~~In patient		1						1	Lymphadenopathy; Oedema peripheral	FLU3~PFIZER\WYETH~4998255~3~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1584H~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0130299	11/04/1999	NY	50.0	50		F	11/03/1999	upper rt arm pain-20min post vax arm swelled doubling in size w/rash, painful to touch, limited motion;									Y	11/01/1999	11/01/1999	0	NONE	PVT	OTH	Fezamax;Prevasi;Clarion;FLovent;Ceravent;Nasocort;Idazapam;selecsa;	NONE	COPD, Enphazeme;osteoparosis;bronchitis;	~ ()~~~In patient		1						1	Hypokinesia; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0130300	11/04/1999	CA	46.0	46		F	11/03/1999	c/o fatigue, swelling inj site, chills, nausea x 3 days;resolved w/o medical intervention;									Y	10/25/1999	10/26/1999	1	NONE	OTH	OTH	Synthroid;Allegra	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Chills; Injection site oedema; Nausea	FLU3~CONNAUGHT LABORATORIES~U0167AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130301	11/04/1999	NE	70.0	70		F	11/03/1999	rt arm swelled from shoulder to elbow, warm to touch, hard & very tender to touch, low grade fever;tx ice, APAP;									Y	10/25/1999	10/26/1999	1		PUB	PUB	Coumadin	NONe	CVA	~ ()~~~In patient		1						1	Injection site mass; Injection site oedema; Injection site pain; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0132AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1211J~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0130302	11/04/1999	WV	49.0	49		M	10/27/1999	p/vax pt devel hives approx 1hr p/vax;when examined 2hr p/vax had 2 1/2cm papules on neck;exp dyspnea or dysphagia;									Y	10/27/1999	10/27/1999	0	NA	PVT	PVT		NONE	allergic to biaxin;	~ ()~~~In patient		1						1	Rash maculo-papular; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~03079P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130304	11/04/1999	NH	43.0	43		F	11/02/1999	p/vax pt exp pain in lt upper arm;bandaid applied @ inj was removed & skin came w/it;a cellulitis rxn;tx w/Augmentin;										10/19/1999	10/19/1999	0	NKA	UNK	UNK			NKA	~ ()~~~In patient		1						1	Cellulitis; Injection site pain; Injury; Skin disorder	FLU3~PFIZER\WYETH~4998220~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130306	11/04/1999	PA	72.0	71		F	10/13/1999	maculopapular rash on back torso;itchy;									Y	09/29/1999	09/30/1999	1		PVT	PVT	NONE	NONE	smoker, arthritis	~ ()~~~In patient	PA9971	1						1	Pruritus; Rash maculo-papular	FLU3~PARKDALE PHARMACEUTICALS~03079P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130308	11/04/1999	MA	36.0	36		F	11/01/1999	broke out w/hives on arms, legs, back & abd;started on 10/29/99 still present 11/1/99;no rxn OTC;advised to report to own MD;given DPH;									Y	10/28/1999	10/29/1999	1	NA	PUB	PUB		NONE	NONE	NONE~ ()~~~In patient	MA9918	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~U0107AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130311	11/04/1999	WA	46.0	46		F	11/01/1999	p/vax exp dizziness & vertigo;					Y				U	10/15/1999	10/16/1999	1		PUB	PUB	NONE	PMJ			WA991616	1						1	Dizziness; Vertigo	FLU3~PFIZER\WYETH~4998344~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0130315	11/05/1999	TX	38.0	38		F	10/28/1999	p/vax devel resp distress & visible neck swelling;pt taken to ER & tx w/epi, solu-medrol & DPH;pt hosp x 24hr;pt had not returned to work as of 10/22/99;reporter noted pt asthma was controlled 7 had been having exacerbation asthma prior vax				Y	Y	1			U	09/30/1999	09/30/1999	0	unk	PVT	OTH	unk	asthma exacerbation	asthma nos		33622250CT199	1						1	Asthma; Condition aggravated; Dyspnoea; Laryngeal oedema	FLU3~PFIZER\WYETH~4998259~2~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0130316	11/05/1999	TN	47.0	47		M	11/01/1999	p/vax pt devel thrombocytopenia purpura & hosp 10/14/99;remained in the ICU as of 10/26/99;				Y	Y				U	10/12/1999	10/14/1999	2	unk	PVT	OTH	Amitriptyline;glucophage;Humulin 70/30;Npaorxen;Nitropaste;Zocor;	NONE	angina pectoris;diabetes mellitus NOS;hypercholesterolaemia;		3684127OCT199	1						1	Thrombocytopenic purpura	FLU3~PFIZER\WYETH~4998214~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0130317	11/05/1999	OK				F	11/02/1999	p/vax pt devel fever of 101 to 103;pt seen by MD;lab results revealed a decreased hgb & hct & elevated BUN & serum creatinine;exp weakness, dizziness & appeared pale;hosp given blood;dx hemolytic anemia of unk etiology & renal failure;				Y	Y	3			Y	10/12/1999	10/13/1999	1	haemoglobin-8.5;haematocrit 27.5;BUN 50;blood creatinine 3.5;	PVT	OTH	unk	NONE	unk		3826528OCT199	1						1	Asthenia; Blood creatinine increased; Blood urea increased; Dizziness; Haemolytic anaemia; Pallor; Pyrexia; Renal failure	FLU3~PFIZER\WYETH~4998227~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0130318	11/05/1999	NY				U	10/28/1999	p/vax pt devel resp arrest & died;it was reported that medical director felt there was no connection between vax & events;	Y	10/19/1999							N	10/12/1999	10/19/1999	7	unk	OTH	OTH	unk	unk	unk		3030320OCT199	1						1	Apnoea	FLU3~PFIZER\WYETH~4998212~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0130331	11/05/1999	ID	23.0	23		F	10/28/1999	localized redness, itching & hardness of tissue;				Y					Y	10/26/1999	10/27/1999	1	NA	PUB	UNK	NONE	NA		~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Pruritus	FLU3~CONNAUGHT LABORATORIES~U1030AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0230J~2~IM~LA~HEP B (RECOMBIVAX HB)~1|MMR~MERCK & CO. INC.~0548J~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TD~LEDERLE LABORATORIES~454611~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0130334	11/05/1999	KS	60.0	60		F	10/21/1999	p/vax pt noticed itching, heat @ site;area bright red w/purple around the edges;applied ice throughout noc;8 1/2cm length x 4 1/2cm wide;red/purple, warm to touch;				Y					Y	10/18/1999	10/18/1999	0	NONE	PUB	PVT	Premarin, Glucophage, Synthroid;Tenormin	well		NONE~ ()~~~In patient	KS99031	1						1	Ecchymosis; Injection site hypersensitivity; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4998211~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0130337	11/05/1999	UT				U	11/01/1999	p/vax pt devel bilat paralysis of lower extremities which resolved w/in several days;the reporter declined to provide further info;this event is considered medically important;									Y				unk	OTH	OTH	unk	unk	unk		3914228OCT199	1						1	Paralysis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130339	11/05/1999	NY				F	10/28/1999	p/vax pt exp 4 sz;pt has a hx of childhood sz & has been sz-free for 10 to 15 years;									U	10/21/1999	10/24/1999	3	unk	OTH	OTH	unk	unk	severe mental retardation;convulsions NOS;		3540826OCT199	1						1	Condition aggravated; Convulsion	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130344	11/05/1999	KS	39.0	39		M	10/12/1999	p/vax pt reported hives on legs & abd;T99.5;3hr post vax T101.5;rash gone by AM;c/o achy joints & some chilling in evening;cough & cold sx;itching;									Y	10/11/1999	10/11/1999	0	NOEN	PUB	PUB	APAP PRN	NONE	allergic to scopolomine-back problems;	NONE~ ()~~~In patient	KS99024	1						1	Arthralgia; Chills; Cough; Pruritus; Pyrexia; Urticaria	FLU3~PFIZER\WYETH~4998211~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130345	11/05/1999	KS	72.0	72		F	10/14/1999	w/in 24hr of vax arm felt bruised, blotchy redness w/swelling than subsided to confluent redness et swelling subsided in 72hr;									Y	10/07/1999	10/08/1999	1	NONE	PVT	PVT	mult vit;Atenolol;Premarin;Xanax;Advil;Guratuss, Vit E or Elavil;	NONE	MVP palpitations, sleep disorder, chronic Rt ETD diverticulosis;DJD;allergic rhinits/atopic dermatitis hx;	NONE~ ()~~~In patient	KS99025	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~U0094AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~458582~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0130346	11/05/1999	KS	66.0	66		M	10/14/1999	w/in 24hr arm felt like boil entire upper arm red swollen et edema for 4 days w/gradual subsiding w/no tx;									Y	10/07/1999	10/08/1999	1	NONE	PVT	PVT	Zocor;Lotrel	hoarseness & rlantasfascivtis	HTn, cAD w/aortic stenosis, DM, COPD, hyperlipidemia	NONE~ ()~~~In patient	KS99026	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~U0094AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~458582~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0130347	11/05/1999	KS	14.0	14		M	10/18/1999	urticaria behind ear, a few on chest & back;tx w/DPH;									Y	10/16/1999	10/16/1999	0	NA	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	KS99027	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130348	11/05/1999	KS	67.0	67		F	10/20/1999	w/in 4hr of vax pt report swelling, red, tender, hot, rt arm from shot;stopped by clinic;tx w/inc fluids, zyrtec, aleve;									Y	10/19/1999	10/19/1999	0	NONE	PVT	PVT	vitamins	NONE	hx of irregular heart beat hx;	NONE~ ()~~~In patient	KS99030	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0094AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~459041~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0130352	11/05/1999	OH	46.0			F		p/vax pt had severe hot pains down lt arm & across top of breast, to neck to back;called MD;pt not seen;c/o temp during noc but didn't take temp had red raised hard area @ inj site;sore to touch;hand sl edema;									Y	10/14/1999	10/14/1999	0	NONE	OTH	PVT		NONE	cortisone	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Oedema peripheral; Pain; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4998233~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130357	11/05/1999	ME	66.0	66		M	09/23/1999	swelling rt arm, redness, warm, arm sized doubled very sore;										09/21/1999	09/21/1999	0	NONE	UNK	UNK	Flovent, Servent-asthma	NONE	asthma, sinus allergies	~ ()~~~In patient		1						1	Oedema peripheral; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4998226~7+~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1585H~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0130358	11/05/1999	ME	8.0	8		M	10/29/1999	rt arm shoulder to elbow-wide as blood pressure cuff poss 4-5 wide band of red, swollen & sore;yesterday PM started;got bigger overnoc;painful & itchy;cool compress & APAP;									U	10/27/1999	10/28/1999	1	NONE	PVT	PUB	Dilantin;Depakote;Imipramine;	10/3 sz activity hosp	cerebral palsy-epilepsy & allergy sulfa drugs;	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0144AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129365	11/08/1999	MD	35.0	35		F	10/29/1999	p/vax pt exp severe pain, redness, swelling, SOB & fever;pt was brought to ER by amb approx 9-10 hr post vax;pt was in hosp for several hr & then discharged @ approx 2am next day;next day pt re-admitted to another ER & kept in hosp x 3 days60 day follow-up received on 10/25/00 provided no additional data.				Y	Y				U	10/12/1999	10/12/1999	0		OTH	OTH	unk		unk		WAES99102112	1						2	Anaphylactoid reaction; Hypokinesia; Injection site oedema; Injection site pain; Laryngospasm; Pruritus; Dyspnoea; Oedema peripheral; Pain; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4998265~3~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1692H~2~IM~~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~~2~~~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0130005	11/08/1999	CA	58.0	58		F	10/25/1999	p/vax pt noticed tenderness & redness @ site;went to employee hlth 60mm induration,cool to touch;sent for eval by MD;				Y					Y	10/22/1999	10/23/1999	1		PVT	PUB		local 60mm induration	similar rxn to estrogen inj (preservative?)	NONE~ ()~~~In patient	CA990126	1						2	Injection site hypersensitivity; Injection site mass; Injection site pain; Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~MEDEVA PHARMA, LTD.~E33609KA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~E33609KA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0130512	11/08/1999	IN	57.0	57		F	11/02/1999	p/vax pt devel a fever of 102 & inj site rxn characterized by swelling & large bolus blisters which spread down the arm;pt hosp & treated w/ATB;pt discharged p/4 days & recovered;					Y	4			Y	10/08/1999	10/18/1999	10	unk	PUB	OTH	unk	NONE	unk		3702127OCT199	1						1	Dermatitis bullous; Injection site hypersensitivity; Injection site oedema; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~458585~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0130547	11/08/1999	SC	68.0	67		F	11/02/1999	p/vax pt had stabbing pain under rt shoulder blade;next morning pain returned in same place;took APAP;sharp pain remained all Friday;felt bad all week end but somewhat better;pain cont ;to MD who felt r/t shots;				Y					Y	10/21/1999	10/22/1999	1	10/29/99 CXR-negative;	PUB	PUB	Atenolol;Hydrochlorothiazide;PRN Relaflen;Lipitor;Centrum Silver;vitamin E	NONE	allergy no medication	NONE~ ()~~~In patient		1						1	Back pain; Malaise	FLU3~CONNAUGHT LABORATORIES~U0145BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1094H~1~SC~RA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~0998960~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0130548	11/08/1999		30.0	30		M	10/27/1999	approx 30min p/vax pt c/o tightness in throat & chest & upper chest pain;tx w/ epi & solumedrol & albuterol by nebulizer & got relief about 1hr p/tx;				Y					Y	10/25/1999	10/25/1999	0	pulse oximetry, vital signs, auscultation;	MIL	MIL			prev similar rxn to flu shots, allergies (environmental)	pt exp rxn w/flu vax;~ ()~~0.00~Patient		1						1	Chest pain; Laryngospasm	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0130550	11/08/1999	KY	40.0	40		F	10/25/1999	pt reports feeling tingling & fullness in face, numbness in head which radiated into shoulders;recv oral antihistamine from PMD;sx resolved by 630PM on 11/19/99;felt no 2-3 days later;				Y					Y	10/19/1999	10/19/1999	0	NONe	PUB	PUB	NONE	NONE	PCN & Sulfa allergy	NONE~ ()~~~In patient	KY990050	1						1	Face oedema; Paraesthesia	FLU3~PFIZER\WYETH~4998221~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0130552	11/08/1999	MI	84.0	84		M	10/27/1999	pain in rt shoulders, arm & back pain;very weak;c/o pain in rt arm & muscle aches;pain in arm where recv vax;feverish;body aches;BP 130/80;T100.4;HR 84, R 14;rt arm pain & gen body aches secondary to influenza vax rxn;				Y					U	10/08/1999	10/08/1999	0	NONE	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient	MI99101	1						1	Asthenia; Back pain; Hypertension; Injection site pain; Myalgia; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0130553	11/08/1999	KY	67.0	67		F		swelling in upper lt arm in deltoid w/sl redness then fainting episode during the noc w/extreme pain;lt upper arm redness in lateral lt upper arm extending down elbow 6 12/ long x 3 1/2 wide;advise moist compresses, anti-inflam drug;				Y					Y	10/19/1999	10/19/1999	0	NONE	PUB	PUB	Zyrtec;Advil	NONE	NKA	NONE~ ()~~~In patient	KY990051	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Syncope	FLU3~PFIZER\WYETH~4998237~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~455936~1~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0130554	11/08/1999	NC	60.0	60		F	10/20/1999	15-20min p/vax c/o throat feeling numb;unable to swallow, SOB, flushed (had similar rxn to cortisone inj);				Y					Y	10/20/1999	10/20/1999	0	NA	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	NC99084	1						1	Dysphagia; Dyspnoea; Paraesthesia; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~03279P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0130555	11/08/1999	MI	59.0	59		F	10/26/1999	site of inj warm & red-rash began on trunk of body;advised by MD to get DPH;seen in ER nauseated, SOB, weak, rash over entire body;02 given;				Y						10/19/1999	10/20/1999	1		PUB	PUB			most ATB, animals, molds, grass, dust, citrus, detergents;	~ ()~~~In patient	MI99105	1						1	Asthenia; Dyspnoea; Injection site hypersensitivity; Nausea; Rash; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02979P~2~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0130558	11/08/1999	CA	55.0	55		F	10/27/1999	pt noted swelling @ site of vax 1/2 day post vax;felt feverish;office visit 7x9cm erythematous, edematous induration;tx w/APAP, DPH & cooling measures;10/22/99 seen by PMD;				Y					Y	10/18/1999	10/19/1999	1	NONE	PUB	PUB	Atenonol;Wellburtin	NONE	HTN;hx of unspecified autoimmune disorder;	~ ()~~~In patient	CA990125	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0130AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~459041~1~SC~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0130560	11/08/1999	HI	55.0	55		F	11/02/1999	fever 102, urticaria, leg swelling;				Y					Y	10/12/1999	10/13/1999	1	NA	PVT	PVT	provarin;calcan, vit d,cortisone,cozera, colebrex;			NA~ ()~~~In patient		1						1	Face oedema; Pyrexia; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~4099G010~4~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0130561	11/08/1999	CA	51.0	51		M	11/03/1999	fever, body aches, chills;				Y					U	11/01/1999	11/01/1999	0		PVT	UNK		NONE	NONE	NONE~ ()~~~In patient		1						1	Chills; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4998287~3~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0130562	11/08/1999	NC	57.0	57		M	11/03/1999	throat swelled up still c/o of soreness & swelling on 11/3/99;									U	11/01/1999	11/01/1999	0		PVT	PVT	Neurontin;gemfibrozil;Covera-HS;Prevacid;Elavil;Xanax;	NONE	COPD, acute anxiety, HTN	~ ()~~~In patient		1						1	Laryngospasm; Oedema; Pain	FLU3~CONNAUGHT LABORATORIES~U0152AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130564	11/08/1999	AZ	45.0	45		F	11/05/1999	T101 x 2 days, sore throat, chills, fever, achy, joints that hurt, felt like hit by truck, rhinitis, congestion now going into lungs, weakness w/in 24hr inj site sore also;									U	10/30/1999	11/03/1999	4		PVT	PVT	Estrogen	NONE	NONE	NA~ ()~~~In patient		1						1	Arthralgia; Asthenia; Injection site pain; Lung disorder; Pharyngitis; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130565	11/08/1999	TX	26.0	26		M	11/05/1999	each arm-swelling, soreness, hep A x 3-4 days;flu- x 1 day;									Y	10/01/1999	10/01/1999	0	NONE	MIL	MIL	NONE	NONE	NONE	pt exp flu vax w/flu~ ()~~~In patient		1						1	Injection site oedema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~5~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~SMITHKLINE BEECHAM~~4~~~HEP A (HAVRIX)~1	USA		Influenza
0130566	11/08/1999	VA	32.0	32		F	11/05/1999	hoarseness, weakness, nausea, heart rate of 84;									Y	11/05/1999	11/05/1999	0	HR-84	OTH	PVT	allergy	hoarseness	pollne-environment-allergies;	~ ()~~~In patient		1						1	Asthenia; Dysphonia; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130567	11/08/1999	MN	37.0	37		F	11/05/1999	arm warm to touch;40cm welt-red & raised @ inj site x 10 days;									Y	10/25/1999	10/25/1999	0	NONE	PUB	PUB	BC Pills;Synthroid	lt deltoid muscle cramp;	hayfever, PCN & derivatives;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~PFIZER\WYETH~~7+~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130568	11/08/1999	NE	22.0	22		F	11/04/1999	10min post vax pt devel rash on torso neck & upper arm-persisting 20min;pt stated felt hot & ears burned most of evening;also stated felt woozy;									Y	11/02/1999	11/02/1999	0	NONE	OTH	PVT	unk	NONE	gluten allergy	~ ()~~~In patient		1						1	Dizziness; Ear pain; Rash; Vasodilatation	FLU3~PFIZER\WYETH~4998293~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130569	11/08/1999	CA	64.0	63		F	11/04/1999	h/a, general malaise, rx ASA;large muscle groups began to ache;joint pain, sore throat-progressed to chills-hot/cold sx persist for over a week;									N	10/27/1999	10/29/1999	2	NONE	OTH	PUB	Ibuprophen;Butalbital;clariten;Estridial;	NONE	environmental, seasonal-undercontrol	pt exp viral, flu sx @ age 60 w/flu vax;~ ()~~~In patient		1						1	Arthralgia; Headache; Malaise; Myalgia; Pharyngitis; Pyrexia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130571	11/08/1999	AZ	43.0			F	11/05/1999	hives, caladryl & DPH, eyes itch, neck, head, arms, stomach, back, chest p/vax;									Y				NONE	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0144AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130573	11/08/1999	MI	73.0	73		F	10/22/1999	fifty cent size area;c/o red, warm to touch;denies swelling, itching or hardness;									N	10/18/1999	10/19/1999	1		PUB	PUB	Premarin;(Celibrax);	NONE	arthritis;	NONE~ ()~~~In patient	MI99103	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02089P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~CONNAUGHT LABORATORIES~7358AB~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0130575	11/08/1999	MI	62.0	62		F	10/22/1999	c/o lt arm started itching yesterday area is warm & hot to touch & swollen to size of a baseball & hard to touch;might have scratched it because of itching;									N	10/13/1999	10/21/1999	8		PUB	PUB	prempro-hormone	NONE	allergic to PCN, keflex, erythromycin & codeine;	NONE~ ()~~~In patient	MI99106	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pruritus	FLU3~PARKDALE PHARMACEUTICALS~02089P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~CONNAUGHT LABORATORIES~7258BA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0130576	11/08/1999	MI	69.0			F	10/27/1999	red, firm, raised bumps on face, neck, legs;began on face on 10/24/99;no itching associated w/them;had MD appt next week;									U	10/20/1999	10/24/1999	4	NONE	PUB	PUB	Premarin;Fosimax	NONE	NONE	~ ()~~~In patient	MI99107	1						1	Urticaria; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02089P~3~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130578	11/08/1999	CA	44.0	44		F	10/22/1999	muscle is very sore & swollen;large swelling around site;									Y	10/10/1999	10/10/1999	0	NONE	PUB	PVT	Mantoux by Connaught given 10/8/99;	NONE	asthma, allergies;	~ ()~~~In patient		1						1	Injection site oedema; Myalgia; Oedema peripheral	FLU3~PFIZER\WYETH~4998211~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130579	11/08/1999	VA	24.0	24		M	10/12/1999	chills, fever, body aches, nausea;rx medrol dosepack;										10/10/1999			CBC dec platelets;D stick AU-WNL;	PVT	PVT	Motrin		PCN	~ ()~~~In patient		1						1	Myalgia; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0095AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130580	11/08/1999	VA	50.0	50		F	11/04/1999	mildly itchy rash calves & thighs;									U	10/09/1999	10/11/1999	2	NONE	OTH	PVT	Estorgen/Zyrtec;	NONE	tetracycline	~ ()~~~In patient		1						1	Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130581	11/08/1999	CA	57.0	57		M	11/01/1999	pain lt arm;swollen lt arm;mild erythema of upper lt bicep area;									U	10/29/1999	10/29/1999	0	NOne	PUB	PUB	PPD by Parkedale lot# 00769P given 10/29/99;		HTN;arthritis (choulders/back/lt knees);rt hemiplegia;	NA~ ()~~~In patient	CA990138	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~MEDEVA PHARMA, LTD.~E29199HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~459041~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0130582	11/08/1999	OH	63.0	63		M	10/25/1999	1/2hr p/vax pt became ill, dizzy & nauseated;felt funny, muscle weakness, fatigue, fever lasting 48hr;arm was very sore immediately;									Y	10/20/1999	10/20/1999	0		PUB	UNK				~ ()~~~In patient	OH99075	1						1	Asthenia; Dizziness; Malaise; Myasthenic syndrome; Nausea; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0144AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130583	11/08/1999	OH	93.0	93		F	10/26/1999	5hr p/vax pt devel dizziness, nausea, vomiting, chills lasting 3-5hr;pt then slept for several hours;now OK states daughter (24hr post vax);									Y	10/25/1999	10/25/1999	0	NOEN	PUB	PUB				~ ()~~~In patient	OH99076	1						1	Chills; Dizziness; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0144AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130584	11/08/1999	OH	66.0	66		F	10/26/1999	sx began approx 5hr p/vax;rt arm became sore, red & swollen down to fingers;progressed to generalized pain on whole rt side of body;pt thinks also had fever (didn't take temp);sx subsided w/in 24hr;									Y	10/18/1999	10/18/1999	0	NONE	PUB	PUB		NONE		~ ()~~~In patient	OH99077	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0144AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1585H~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0130585	11/08/1999	OH	67.0	66		M	10/26/1999	sx began approx 5hr p/vax rt arm became very sore w/some swelling & redness progressed to generalized muscle pain on rt side including stiff neck;sx subsided w/in 24hr;									Y	10/18/1999	10/18/1999	0	NONE	PUB	PUB				~ ()~~~In patient	OH99078	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Myalgia; Neck pain	FLU3~CONNAUGHT LABORATORIES~U0144AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1585H~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0130589	11/08/1999	WV	38.0	37		F	11/04/1999	p/vax pt c/o soreness of arm;used ice pack for pain;bruising since 11/2/99;11/4/99 pt broke out in hives all over body w/itching;advised to go to ER;									Y	10/29/1999	10/30/1999	1		PUB	UNK	Depo Provera;OTC allergy meds;	NONE		~ ()~~~In patient		1						1	Ecchymosis; Pain; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4998255~5~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130591	11/08/1999	NC	55.0	55		F	11/03/1999	redness & pain around inj site;joint pain, chills lasted until 11/2 around 10PM;									Y	11/01/1999	11/01/1999	0		PVT	PVT	synthroid;	NONE	NONE	~ ()~~~In patient		1						1	Arthralgia; Chills; Injection site hypersensitivity; Injection site pain	FLU3~CONNAUGHT LABORATORIES~U0152AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1246H~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0130592	11/08/1999	GA	18.0	18		M	11/01/1999	hives whole body;denied SOB;advised to take DPH or claritin;took claritin;clearing;									Y	10/28/1999	10/28/1999	0	NONE	OTH	PVT	Celexa;Questran, Prevacid;	NONE	NONE	NONE~ ()~~~In patient		1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~U0102AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~CONNAUGHT LABORATORIES~7126AA~1~SC~RA~MENINGOCOCCAL (MENOMUNE)~1	USA		Influenza
0130593	11/08/1999	SC	26.0	26		F	10/29/1999	bruised, hard area size of silver dollar, edema on inj site & under arm, fever @ inj site only;no systemic complaints;ice pack recommended/APAP for discomfort;swelling has gone;small bruises;									Y	10/27/1999	10/27/1999	0		PUB	PUB	NONE	sl sinus infect	NONE	NONE~ ()~~~In patient		1						1	Ecchymosis; Injection site hypersensitivity; Injection site mass; Injection site oedema; Lymphadenopathy; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0128EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130594	11/08/1999	VA	68.0	67		F	10/25/1999	had rxn to flu vax +myalgias & malaise;better by today 10/15/99;has taken w/o incident in the past;just wanted to let us know;									N	10/14/1999	10/14/1999	0	NA	PUB	OTH	Zyrtec;Evista;Atarax;Prevacid;Asacal;Avapro;Mextaxexate;Folate;	RA, HTN, osteoporosis, hx rheumatic fever;hxo of LCC	nausea p/htx inj;RA, HTN, osteoporosis;rheumatic fever;LCC	~ ()~~~In patient		1						1	Malaise; Myalgia	FLU3~CONNAUGHT LABORATORIES~U0128CA~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130595	11/08/1999	TX	65.0	65		F		marked rt (from elbow to shoulder) arm edema, erythema site of inj rt;									U	10/25/1999	10/26/1999	1		PVT	PVT				NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4998251~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1693H~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0130596	11/08/1999	CA	26.0	26		F	10/28/1999	p/vax c/o lt arm hurting & feeling heavy;pain increased;felt a lot of pain;took APAP;pt exp generalized aching & lt arm numbness;went to bed;awakened 6Am next morning w/no sx;									Y	10/18/1999	10/18/1999	0		OTH	PUB	Atenolol;Multivitamin;		allergies pollen;medical cond hyperthyroidism;	NONE~ ()~~~In patient	CA990127	1						1	Myalgia; Myasthenic syndrome; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4998216~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130597	11/08/1999	MO	52.0			M	10/28/1999	p/vax face swollen (mouth, lips);lasted 24hr;took meds prescribed by MD for allergies;									Y				NA	PUB	PVT	NONE	NA	food allergies-had been eating eggs;	NA~ ()~~~In patient	MO99045	1						1	Face oedema	FLU3~MEDEVA PHARMA, LTD.~E29179HA~1~IM A~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0130599	11/08/1999	FL	13.0	13		F	11/03/1999	broke out w/hives approx 2hr p/vax;given DPH;hives cont off & on for 3 days;									Y	10/29/1999	10/29/1999	0	NONe	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~U0103AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130605	11/09/1999	MS	59.0	58		F	11/03/1999	p/vax pt exp a severe sore throat that became  worse p/ATB;CXR revealed bilat pulmonary infiltrates;pt put on ventilator;pt had an open lung biopsy on10/28'/99;tissue samples show diffuse alveolar damage w/acute & chronic pneumonitis;60 day follow up states the pt died.	Y	11/18/1999			Y				N	10/07/1999	10/08/1999	1	surgical pathology from lt lung biopsy on 10/28/99-diffuse alveolar damage w/acute & chronic penumonitis, hyaline membrane formation, interstitial edema & early organization;	UNK	UNK	Celestone, Ceftin, Proventil HAM, histex HC	NONE			U199900836	1						1	Hypoxia; Pharyngitis; Pulmonary fibrosis; Pulmonary oedema; Respiratory disorder	FLU3~CONNAUGHT LABORATORIES~U0065AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0130607	11/09/1999	IA	33.0	33		F	10/25/1999	p/vax pt devel severe myalgias w/o fever;could not work for 2-3 days;no evidence of GBS; reporting because of severity of illness; 60 day follow-up received on 09/27/00 provided no additional data. Annual follow-up received on 09/27/00 provided no additional data.					Y				Y	10/18/1999	10/23/1999	5	labs-all negative including CK	UNK	UNK			NONE			1						1	Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0130609	11/09/1999	IL	81.0	80		F	10/22/1999	loss of balance, edema of lips, discoloration of hands & feet, blotches et blisters of thighs, buttock; mouth black w/blisters in it;				Y	Y	2			Y	10/01/1999	10/03/1999	2		PUB	UNK	Zantac, B/P med	NONE	hx  colon CA x14yrs w/colostomy	~ ()~~~In patient	IL99073	1						1	Coordination abnormal; Dermatitis bullous; Face oedema; Mucous membrane disorder; Rash maculo-papular; Skin discolouration	FLU3~CONNAUGHT LABORATORIES~U0095AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0130610	11/09/1999	CA	83.0	83		M	11/05/1999	slurred speech, progressive malaise & weakness x 1wk, numbness & pain rt leg, T102;tx neurological exam, IV fluids, hemodialysis x 1;Annual follow-up dated 12/6/00 provided no additional data. 60 day follow-up dated 2/15/01 provided no additional data.				Y	Y				U	10/22/1999	10/31/1999	9	renal ultrasound, MRI of brain, CXR, lab work-BUN 101, creatinine 9.4 11/5/99;	PVT	PVT	Ecotrin, Proscar, Prilosec, Miraplex, Hydroxyurea, chondriten, glucosomine	NONE	NKA			1						1	Asthenia; Blood creatinine increased; Blood urea increased; Malaise; Pain; Paraesthesia; Pyrexia; Speech disorder	FLU3~CONNAUGHT LABORATORIES~U0102AA~5~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0130611	11/09/1999	WA	36.0	36		F	10/28/1999	p/vax pt had hives both legs & lt arm (inj given lt deltoid);pt seen on 10/25/99 & pred prescribed;				Y					Y	10/21/1999	10/23/1999	2		PVT	PVT		NONE	cipro	~ ()~~~In patient		1						1	Urticaria	FLU3~PFIZER\WYETH~4998259~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0130614	11/09/1999	CA	51.0	51		F	11/04/1999	1 day p/vax pt devel swelling lt deltoid & redness-15x16cm indurated, sl tender given DPH & ice;now better 2 days later (8.5 x 9.5cm);				Y					N	10/31/1999	11/01/1999	1		PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~U016AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0130616	11/09/1999	IL	49.0	49		F	10/21/1999	pt devel h/a, body ache, T104, joint pain, cough, congestion;				Y					U	10/19/1999				PUB	PVT	unk	NONE	denied any allergies	~ ()~~~In patient		1						1	Arthralgia; Cough; Headache; Myalgia; Pharyngitis; Pyrexia; Rhinitis	FLU3~PFIZER\WYETH~4998231~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1693H~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0130618	11/09/1999	NC	57.0	57		F	10/29/1999	p/vax pt c/o lt deltoid @ inj site itching & hot to touch & feeling nauseated & dizzy;inj site red & warm to touch;pt pale & nauseated w/dry heaves;911 called & to ER d/t hx severe allerg rxn to vax;allerg rxn;chest pain & sz in ER;									Y	10/28/1999	10/28/1999	0		PUB	PVT	Premarin, Paxil, HCTZ	c/o h/a	tetanus hepatitis B	pt devel swelling throat & joint, n, dizziness w/Td~ ()~~~In patient	NC99085	1						1	Dizziness; Hypersensitivity; Injection site hypersensitivity; Nausea; Pallor; Pruritus; Vasodilatation; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E26119HA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0130620	11/09/1999	VA	33.0	33		F	10/22/1999	p/vax pt started wheezing & diff swallowing;arrived @ hosp 12:30 p/calling around for appt, couldn't fine one;went to ER;recv solumedrol, DPH, epi, proventil/albuterol;stable by 250PM;				Y					Y	10/07/1999	10/07/1999	0	pulse oximetry, vital signs nl;	MIL	OTH	NONE	NONE	allergy to amoxicillin	~ ()~~~In patient		1						1	Asthma; Dysphagia	FLU3~CONNAUGHT LABORATORIES~U0135AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0130624	11/09/1999	MI	35.0	35		F	10/26/1999	p/vax pt c/o SOB, throat swelling, increase resp rate, decrease pulse oximetry to 90% RA;pt treated w/epi, DPH & Solumedrol w/complete resolution of sx;adm to hosp x 3hr for observation & did well;										10/19/1999	10/19/1999	0		UNK	UNK				~ ()~~~In patient		1						1	Dyspnoea; Hyperventilation; Hypoxia; Laryngospasm	FLU3~PARKDALE PHARMACEUTICALS~02779P~UNK~SC~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~0042J~UNK~SC~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0130626	11/09/1999	WI	46.0	46		F	11/08/1999	p/vax pt had an elevated temp of 100 w/a h/a, achy muscles, generalized aching throughout the body;pt called nurse & was told to take APAP for the fever;it went away in 12hr;										11/05/1999				PUB	UNK				~ ()~~~In patient		1						1	Headache; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4998214~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130627	11/09/1999	IL	72.0	72		M	10/27/1999	p/vax pt rt arm (pneumonia vax) puffy & swollen, hot, hard & very red;									Y	10/26/1999	10/26/1999	0		PUB	UNK		NONE	NONE	~ ()~~~In patient	IL99072	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0130630	11/09/1999	MN	44.0	44		F	11/03/1999	rash on body-itches-appeared approx 8PM on 11/2/99;on concurrently septra for ear infect;AM to take DPH until itching sx goes away;									N	11/02/1999	11/02/1999	0		PUB	PVT	NONE	ear infect		~ ()~~~In patient		1						1	Ear disorder; Infection; Pruritus; Rash	FLU3~PARKDALE PHARMACEUTICALS~02189P~2~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130631	11/09/1999	KS	76.0	76		M	11/02/1999	day p/vax rt arm swelled up form finger tips to shoulder blades;most of swelling occurred on neck side of arm;no redness or heat to area;lasted 5 days;pt feels in a vacuum out of balance;									U	10/15/1999	10/16/1999	1		PUB	PUB		NONE	states gets hives & swells up when gets a Td	pt exp swelling w/Td~ ()~~~In patient		1						1	Coordination abnormal; Injection site oedema; Oedema peripheral	FLU3~PARKDALE PHARMACEUTICALS~01889P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1247H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0130632	11/09/1999	MS	74.0	74		M	10/19/1999	dx allergic hypersensitivity;pt reports swelling of tongue;										10/18/1999	10/18/1999	0	NONE	UNK	UNK				~ ()~~~In patient		1						1	Hypersensitivity; Tongue oedema	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130636	11/09/1999	CA	3.0	3		F	11/03/1999	5min p/vax redness, warmth, swelling @ site;									U	11/02/1999	11/02/1999	0	NONE	PVT	PVT	Enlefzil	ear infect	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0148AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129826	11/10/1999	WI	77.0	77		F	10/22/1999	pt does not see MD-takes many vitamins & herbs;pt has had cough & congestion recently;pt stated not ill day of vax;apparently found dead in morning;	Y	10/07/1999							N	10/06/1999	10/07/1999	1	unk	PUB	PVT	takes vitamins & herbs	pt denied any illness to nurse;	pt does not have a MD;	NONE~ ()~~~In patient		1						2	Cough; Lung disorder; Myocardial infarction; Right ventricular failure; Myocardial infarction; Right ventricular failure	FLU3~CONNAUGHT LABORATORIES~U0126FA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0126FA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~459039~1~IM~RA~PNEUMO (PNU-IMUNE)~2	USA	Results in Death	Influenza
0130647	11/10/1999	AZ	47.0	47		M	11/08/1999	severe fever, chills, convuls nausea, sweats, rash, blood in urine, liver function abn-possible hep being eval;Annual follow-up dated 12/18/00 provided no additional data.			Y	Y					U	11/05/1999	11/06/1999	1	blood/urine-no results as yet	MIL	MIL	Prilosec, lisinopril, lithium carbonate, Erythromycin	toothache	allergy:  Reglan, PCN			1						1	Convulsion; Haematuria; Hepatic function abnormal; Hepatitis; Hyperhidrosis; Nausea; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0130653	11/10/1999	MN	75.0	75		M	11/04/1999	numbness feet & lower legs & inc leg weakness, mild dysarthria, mildly reduced resp capacity;still unable to ambulate as of 11/4/99;tx plasmaphoresis IVIG;states 11/2 dx GBS; 60 day follow-up dated 10/16/00 provided no additional data.					Y				N	10/13/1999	10/21/1999	8	10/25/99 CSF protein=226	OTH	UNK	ASA, Lasix, Indur, Lipitor, Atenolol, Potossium, NTG PRN	NONE	NKA;sleep apnea, hyperglycemia, coronary vascular disease, chronic low back pain;			1						1	Chest pain; Dysarthria; Dyspnoea; Guillain-Barre syndrome; Hypoventilation; Myasthenic syndrome; Paraesthesia	FLU3~PFIZER\WYETH~4998281~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0130654	11/10/1999	PA	28.0	28		F	10/06/1999	devel hives, phlegm in throat contacted own personal MD by phone called prescription for DPH;all sx resolved 10/7/99;				Y					Y	10/06/1999	10/06/1999	0	NONE	OTH	PVT	NONE	hives	NONE	NONE~ ()~~~In patient		1						1	Salivary hypersecretion; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0127AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0130657	11/10/1999	OK	9.0	9		M	11/09/1999	p/vax pt reported not feeling well;pt was shaking uncontrollable;T97.6, pulse 96, resp 18, BP 80/60;mom phoned & pt taken to MD;				Y					Y	11/04/1999	11/04/1999	0		OTH	OTH		NONE		~ ()~~~In patient		1						1	Hypotension; Hypothermia; Hypoventilation; Malaise; Tremor	FLU3~CONNAUGHT LABORATORIES~U0205AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0130659	11/10/1999	TX	29.0	29		M	11/09/1999	pt driving home p/vax @ bank passed out & ran through fence & hit house p/getting dizzy, then was awaken by home owner unaware of happenings;				Y					Y	10/28/1999			CT head (large laceration);	OTH	OTH		NONE	NONE	~ ()~~~In patient		1						1	Dizziness; Injury; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0130660	11/10/1999	VA	46.0	46		F	10/28/1999	p/vax pt c/o feeling dizzy & woozy, hot at 1045AM;had pt place head between knees, cold towel to forehead, coke to drink;pt then looked flushed, pulse 80 & regular;c/o tingling feeling in jaw area;to MD;				Y					Y	10/28/1999	10/28/1999	0		PUB	PUB	hormone therapy		codeine, sulfa	~ ()~~~In patient	VA99057	1						1	Dizziness; Paraesthesia; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02089P~2~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~SMITHKLINE BEECHAM~3066A4~1~IM~LA~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0130662	11/10/1999	NY	67.0	66		F	11/05/1999	induration, pain & erythema @ inj site;lymphadenopathy axillary area;afeb;sx began 24hr p/vax;tx w/cipro;				Y					U	11/02/1999	11/03/1999	1		PVT	PVT	Prilosec;Premain;	NONE	allergies: vicks vapor rub, PCN;dx hyperlipidemia;	unk~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Lymphadenopathy	FLU3~CONNAUGHT LABORATORIES~U0157AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0042J~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0130663	11/10/1999	PA	34.0	33		F	10/06/1999	increased phlegm in throat-felt like lump back of throat lasted several hours-onset 2hr p/vax; all sx resolved 10/7/99;									Y	10/06/1999	10/06/1999	0	NONE	OTH	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Laryngospasm; Salivary hypersecretion	FLU3~CONNAUGHT LABORATORIES~U0127AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130664	11/10/1999	OH	50.0	50		M	10/06/1999	felt like lump in throat-a lot of phlegm lasted all day; started 2hr p/vax; all sx resolved 10/7/99;									Y	10/06/1999	10/06/1999	0	NONE	OTH	PVT	NONE	NONE	NONE	NA~ ()~~~In patient		1						1	Laryngospasm; Salivary hypersecretion	FLU3~CONNAUGHT LABORATORIES~U0127AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130665	11/10/1999	WA	51.0	51		F	11/09/1999	tingling down arm flu sx-flush-feverish feeling x 3 days;extreme dizziness;									Y	11/02/1999	11/02/1999	0	NONE	PVT	PVT	Estrabb;hydrochlorcothorazide;dicipromene;propanelol	NONE	high BP, iodine (ingested);percodan;flagil;	~ ()~~~In patient		1						1	Dizziness; Influenza; Paraesthesia; Pyrexia; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130666	11/10/1999	WI	4.0	4		M	11/09/1999	fever 101, redness & swelling 5cm like rashes, rashes 1-4cm @ inj site;pt recv flu vax 11/8/99 and 10/11/99;									Y	11/08/1999	11/09/1999	1	NONE	PVT	OTH		NONE	nuts, hx of IGG & IGA until age 2;	pt did not take gave IPV-OPV;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pyrexia; Rash	FLU3~PFIZER\WYETH~~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130667	11/10/1999	OH	88.0	88		F	11/09/1999	rash on face, very fine bumps, itchy dry;									U	11/05/1999	11/08/1999	3	NONE	PVT	PVT	Diamex;Procardia;Naprosyn	NONE	poor circulation, glaucoma, high bp	~ ()~~~In patient		1						1	Dry skin; Pruritus; Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130672	11/10/1999	VA	70.0	70		F	10/29/1999	approx 2hr p/vax pt exp itching & burning predominately on arms, thighs, hips & legs;rash devel 9subdermal raised) on extremities upper & lower;pt self treated w/aloe lotion & oatmeal baths;									Y	10/27/1999	10/27/1999	0	NONE	PUB	UNK	glucophage;glyburide	NONE	no allergies;dx HTN;AODM	~ ()~~~In patient	VA99059	1						1	Pain; Pruritus; Rash maculo-papular	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130673	11/10/1999	VA	73.0	73		M	11/01/1999	arm from above elbow to mid-forearm swelled severely & was very warm to touch;no fever;sx started 36-48hr p/vax; by 4 days p/inj was improving greatly;									Y	10/26/1999	10/28/1999	2		PUB	PUB		NONE		~ ()~~~In patient	VA99058	1						1	Oedema; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02089P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~454964~1~SC~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0130674	11/10/1999	NY	40.0	39		F	11/04/1999	6hr p/vax pt c/o nausea, vomiting, weakness, myalgia, T100-101;sx lasted approx 40hr;used APAP alternating w/Ibuprofen or naproxen;									Y	11/02/1999	11/02/1999	0	NA	PVT	PVT	Remeron;Flonase nasal spray	NONE	allergies to sulfa, macrobid, lorabid, dx asthma, allergic rhinitis	unk~ ()~~~In patient		1						1	Asthenia; Myalgia; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0157AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SMITHKLINE BEECHAM~3090A6~1~IM~RA~HEP B (ENGERIX-B)~1|TD~PFIZER\WYETH~4988120~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0130675	11/10/1999	CT	20.0	20		F	11/09/1999	local redness & heat @ inj site rt arm;									N	11/03/1999	11/03/1999	0		OTH	PVT		NONE	NONE			1						1	Injection site hypersensitivity; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0207AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~CONNAUGHT LABORATORIES~7126AA~1~~RA~MENINGOCOCCAL (MENOMUNE)~1	USA		Influenza
0130676	11/10/1999	MI	73.0	73		F	10/27/1999	rt deltoid area became swollen, red, hot, about 10/24/99 p/vax;area also became raised about size (approx 5cm in diameter);has not sought medical f/u;									Y	10/20/1999	10/25/1999	5	NONE	PUB	PUB	NKD	NONE	NKDA	~ ()~~~In patient	MI-99-115	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~CONNAUGHT LABORATORIES~7358AB~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0130677	11/10/1999	IN	36.0	36		M	11/10/1999	3min p/vax pt was diaphoretic & pale;faint & feeble;face pink;BP 60/0;R30 labored;									Y	10/30/1999	10/30/1999	0	NONE	OTH	OTH		NONE	NONE	~ ()~~~In patient		1						1	Bradycardia; Dizziness; Dyspnoea; Hyperhidrosis; Hyperventilation; Hypotension; Pallor; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~40108CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130679	11/12/1999	CA	33.0			F	10/28/1999	p/vax devel neck, lung & lymph node pain;									U	10/24/1999	10/25/1999	1		OTH	PVT			many allergies	~ ()~~~In patient		1						1	Chest pain; Neck pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130703	11/12/1999	VA	55.0	55		F	11/03/1999	p/vax pt red, fiery arm from flu shot;reddened area the size of small saucer;told to use ice on arm;reported no SOB, wheezing, told to seek medical care if w/o improvement;severe local rxn;				Y					Y	11/01/1999	11/01/1999	0		PUB	UNK				NONE~ ()~~~In patient	VA99060	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0130708	11/12/1999	MN	38.0	38		M	11/03/1999	status pt confused & feeling faint;BP 70/40, P 40 weak;very pale, clammy;another person waiting for shot saw hand & head jerking;not seen by RN;epig vien;sent to ER by amb;				Y					U	11/03/1999	11/03/1999	0		MIL	PVT		NONE	NONE	~ ()~~~In patient		1						1	Bradycardia; Confusional state; Dizziness; Hyperhidrosis; Hypotension; Pallor	FLU3~CONNAUGHT LABORATORIES~U0131AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0130709	11/12/1999	SC	44.0	44		F	10/28/1999	p/vax pt lt arm became swollen, reddened & sore;pt devel fever & chills;called MD & told to use APAP & Ibuprofen;ice packs used w/relief;saw MD & given steroid inj;advised not to take Td & pneumonia inj again by MD;				Y					Y	10/21/1999	10/22/1999	1		PUB	PUB		NONE		~ ()~~~In patient	SC99068	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0131AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1095H~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~U0011AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0130710	11/12/1999	CA	64.0	64		F	11/01/1999	p/vax pt throat started to feel swollen-diff swallowing;called 911;paramedics arrived shortly;BP 190/90 given med;pt refused going to ER;started feeling a little better but throat tight;				Y					Y	10/21/1999	10/21/1999	0		PUB	PUB	procardia;Mevacore;Premarin;buspar	NONE	HTn,high cholesterol;	~ ()~~~In patient	CA990129	1						1	Dysphagia; Hypertension; Laryngospasm	FLU3~CONNAUGHT LABORATORIES~U0095AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0130711	11/12/1999	CA	39.0	39		F	11/04/1999	tingling in lt arm & hand, achiness, pain @ inj site;seen @ occupational hlth on 11/4/99;				Y					U	10/12/1999	10/13/1999	1		PUB	PUB	NONE	NONE	allergic to PCN	NONE~ ()~~~In patient	CA990130	1						1	Injection site pain; Myalgia; Paraesthesia	FLU3~PFIZER\WYETH~4998221~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0130713	11/12/1999	SC	55.0	55		F	11/05/1999	had 10mm+  welt below inj site the eve it was given for about 3 days;felt weak, nausea, h/a;had memory loss sate eve;could not remember what ingredient to use to prepare dish fixed often;5 days before felt normal;									U	10/15/1999	10/15/1999	0		PUB	PUB	Klonopin;Effxer;Tamoxifen	NONE	untoward rxn from excedrin	~ ()~~~In patient	SC99070	1						1	Asthenia; Headache; Injection site hypersensitivity; Nausea; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0145BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130714	11/12/1999	MA	43.0	43		F	10/19/1999	redness, erythema, mild discomfort @ site;duration -2 days;									Y	10/06/1999	10/07/1999	1		OTH	PUB	NONE	NONE	sensitive skin-fair complexion	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain	FLU3~CONNAUGHT LABORATORIES~U0107AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130715	11/12/1999	WA	46.0	46		F	10/19/1999	redness, erythema & discomfort @ inj site;duration 2 days;									Y	10/08/1999	10/09/1999	1		OTH	PUB	Atenolol;hydrachlothiazide	NONE	NKA-HTN	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain	FLU3~CONNAUGHT LABORATORIES~U0107AA~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130716	11/12/1999	MA	6.0	6		M	10/18/1999	12hr p/vax T101.5, swelling 36-40 hr massive induration erythema;non febrile;entire arm 1/2 forearm & chest axilla resolving;									Y	10/15/1999	10/16/1999	1		PVT	PUB	NONE	NONE	mild asthma/PCN, ?sulfa allergy	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Lymphadenopathy; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0107AA~4~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130722	11/12/1999	TX	34.0			F	11/08/1999	burning, tender, red, swelling;									Y				NA	PVT	PVT		sinusitis	allergies-GERD-h/a;	~ ()~~~In patient		1						1	Oedema; Pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~4099G010~7+~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130723	11/12/1999	WY	56.0	56		F	11/03/1999	papular rash 20mm lt upper arm @ inj site;pt denies pain or itching;no redness or heat @ site;lesion very similar to herpes zoster w/no pain involved;										10/19/1999	10/31/1999	12	NONE	PUB	PUB		NONE		~ ()~~~In patient	WY9917	1						1	Herpes zoster; Injection site hypersensitivity	FLU3~PFIZER\WYETH~4998209~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130724	11/12/1999	WI	55.0	55		F	11/02/1999	redness, heat, itching from shoulder to elbow front & sides of lt arm x 3 days;no when seen on 11/2/99;									Y	10/26/1999	10/26/1999	0		OTH	PUB	Premarin;Diovan;Covera HS;Pravachol	NONE	NONE x/high BP	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02779P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130726	11/12/1999	CO	50.0	50		F	11/05/1999	p/vax pt exp numbness in mouth & throat;saw MD;dx w/Bells Palsy;									U	11/03/1999	11/03/1999	0		OTH	PUB		NONE	NONE	~ ()~~~In patient		1						1	Facial palsy; Laryngospasm; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~U0111AB~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130728	11/12/1999	GA	28.0	28		F	11/03/1999	p/vax pt attributed sinus congestion to environmental allergies;took med;later w/swelling, redness on hand & feet & raised lesions on buttocks, legs and ears;sx improved w/DPH but lesions & swelling remain;									Y	11/01/1999	11/01/1999	0	NA	OTH	PVT	Mercette	NONE	Environmental	pt devel fever @ infancy;pt sibling devel fever @ infancy p/vax;~ ()~~~In patient		1						1	Oedema peripheral; Rhinitis; Sinusitis; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0102AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130729	11/12/1999	IN	51.0	51		F	11/08/1999	pt devel a fever of 104, chills, muscle aches, h/a, nausea w/no vomiting, w/in 12hr of vax;sx resolved in 72hr;									Y	10/29/1999	10/29/1999	0	NA	PUB	PUB	ASA	NA	lt mastectomy;	~ ()~~~In patient	IN99040	1						1	Headache; Myalgia; Nausea; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1584H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0122103	11/15/1999	PA	67.0			F	11/08/1999	p/vax pt exp pain in what calls drawing in lt upper arm & shoulder;pt noted numbness in lt hand since then;pt feels arm is awkward but doesn't note any actual weakness;poss brachial plexus neuritis;				Y					U	10/12/1998	10/13/1998	1	Neurological eval: this is a shor, obese woman who complains a great deal of the pain in the lt arm;all major joints are freely mobile;no evidence of atrophy or fasciculations;strength is excellent in all muscles of both upper extremities;	PVT	UNK	Serax, Paxil, Arthrotec	unk	has had bilat knee replacements;had appendectomy & hysterectomy;has had carpal tunnel surgery back in 1970 & apparently had done the nerve studeis @ that time;some depression & anxiety & currently takes serax & paxil;arthrotec for joint pro	~ ()~~~In patient	U199900864	1						3	Hypotonia; Movement disorder; Myasthenic syndrome; Pain; Paraesthesia; Neuropathy; Pain; Paraesthesia; Tremor; Arthralgia; Movement disorder; Neuritis; Pain; Paraesthesia	FLU3~PARKDALE PHARMACEUTICALS~0981810~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~2|FLU3~CONNAUGHT LABORATORIES~0981810~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~3	USA	Emergency room visit	Influenza
0129924	11/15/1999	GA	72.0	72		F	10/21/1999	p/vax pt devel small red patches on arm just below inj site (lt deltoid);pt states felt bad & slept all day;took APAP;arm has raised area w/redness & warm to touch;instructed to cont APAP & apply warm compress to area;									U	10/19/1999	10/20/1999	1	NA	PUB	OTH	Calcium;Fosamax;Benozepril;Darvocet;	NONE	allergy to PCn & tetanus;hx of HTN	pt exp rxn @ age 30 w/tetanus unk dose;~ ()~~~In patient	GA99131	1						2	Injection site hypersensitivity; Injection site mass; Malaise; Somnolence; Vasodilatation; Injection site hypersensitivity; Injection site mass; Malaise; Somnolence; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02979P~4~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~455938~2~IM~LA~PNEUMO (PNU-IMUNE)~1|FLU3~PARKDALE PHARMACEUTICALS~02979P~4~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~PFIZER\WYETH~455938~2~IM~LA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0130116	11/15/1999	GA	82.0	82		F	10/13/1999	pt had fever 102 & bodyaches;In bed x 2 days;had flu vax 10/5/99;									Y	10/05/1999	10/06/1999	1	NA	PUB	PUB	unk	unk	NKA	NA~ ()~~~In patient	GA99137	1						2	Myalgia; Pyrexia; Myalgia; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~02979P~7+~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~02979P~7+~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0130284	11/15/1999	CA	49.0	49		M	11/05/1999	p/vax pt exp sudden onset of low back pain;pt went to ER walking w/o problem but devel lower extremity paralysis acutely;				Y	Y				U	10/11/1999	10/30/1999	19	LP, MRI, EKG, Catscan of brain w/o contrast, CXR, CT of pulvis, abd, Lumbar spine;	OTH	PVT			allergic rxn to tetanus-rash, puffiness 1971;	~ ()~~~In patient	U199900863	1						2	Back pain; Hypercholesterolaemia; Leukocytosis; Myelitis; Paralysis; Back pain; Paralysis; Back pain; Paralysis	FLU3~CONNAUGHT LABORATORIES~U0109CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0109CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLUX~UNKNOWN MANUFACTURER~U0109CA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Hospitalisation	Influenza
0130741	11/15/1999	NY	70.0	70		M	11/12/1999	p/vax pt devel fever of 100.5, chills, groin pain & severe pain to lower abd to lt testicle;pt exp hematuria;pt devel orchitis, prostatitis, epididymitis;poss d/t vax;				Y				Y	Y	10/01/1999	10/02/1999	1	10/1/99 unspecified blood work-nl;urine culture-nl;	OTH	OTH			allergic rhinitis	No Relevant Data~ ()~~~In patient	WAES99100392	1						1	Abdominal pain; Epididymitis; Haematuria; Orchitis; Pain; Pelvic pain; Prostatic disorder; Pyrexia; Scrotal oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~~~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0130753	11/15/1999	CA	29.0	29		F	10/18/1999	p/vax pt woke up & felt nervous, had h/a on back of neck & felt discomfort on both arms;felt depressed & crying;chills, h/a, burning of both arms & numbness of face;c/o weakness, malaise & feeling sleepy;					Y	2			Y	10/11/1999	10/12/1999	1		PUB	PUB	oral contraceptive & APAP	NONE		~ ()~~~In patient	CA990137	1						1	Agitation; Asthenia; Chills; Depression; Headache; Hypoaesthesia; Insomnia; Malaise; Nervousness; Pain; Somnolence; Syncope	FLU3~MEDEVA PHARMA, LTD.~E33609KA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|MMR~MERCK & CO. INC.~0543J~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TD~CONNAUGHT LABORATORIES~7258BA~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0130754	11/15/1999	OH	30.0	29		M	11/10/1999	adm to ER w/progressive paralysis, back pain, numbness to leg, hx thrombocytopenia & autoimmune insufficiency;			Y	Y	Y	18			N	10/25/1999	10/30/1999	5	11/2 protein CSF 159.3;albumin CSF 91;IGG serum 456;	OTH	PUB	Pred;folic acid;Vit C	NONE	allergic PCN;splenectomy			1						1	Back pain; Paraesthesia; Paralysis	FLU3~PARKDALE PHARMACEUTICALS~02879P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation	Influenza
0130755	11/15/1999	MD	51.0	51		M	11/01/1999	2-2 1/2hr p/vax lost consciousness;uncontrolled shaking (sz).Hospitalized & dxed w/ new onset seizures.				Y	Y	1			Y	10/29/1999	10/29/1999	0	EEG-nl;CAT Scan-negative;	PUB	PUB	Lescol;Paxil	NONE				1						1	Convulsion; Syncope; Tremor	FLU3~PFIZER\WYETH~4998249~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0130756	11/15/1999	NY	75.0	75		F	11/09/1999	increasing redness, warmth, discomfort;rt upper arm, elbow to axilla beginning 1 day p/vax plus chills-no fever;sx & physical findings resolved completely by day 5 p/inj was started on ATB;					Y	3			Y	11/05/1999	11/06/1999	1	nl CBC (nl WBC, platelets, no eosinophylic);	PVT	PVT		NONE	NKDA;	NONE~ ()~~~In patient		1						1	Chills; Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0132AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0043J~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0130757	11/15/1999	GA	40.0	39		F	10/28/1999	c/o h/a & dizziness;having chills;did not check temp;chest was tight & had trouble breathing;seen by MD;arm warm, dry, dried lesions x 2 on lip;mucoid type exudate;throat w/some erythema & mucoid exudate;BP 130/80, P100, R20;T101.8;				Y					Y	10/27/1999	10/27/1999	0		PUB	PUB	NONE	NONE	NONE	NA~ ()~~~In patient	GA99142	1						1	Chest pain; Chills; Condition aggravated; Dermatitis bullous; Dizziness; Dyspnoea; Headache; Hypertension; Myalgia; Pharyngitis; Pyrexia; Rhinitis; Tachycardia; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02979P~3~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0130759	11/15/1999	FL	49.0	49		M		cold, chills, high fever;migraines, lower back pain;heavy cough;double vision;saw PCP;rx amoxicillin;saw MD 11/10 rx DPH;saw MD 11/11 rx guaifenesin & augmentin;				Y					Y	11/05/1999	11/06/1999	1		OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Back pain; Cough; Diplopia; Pharyngitis; Rhinitis	FLU3~PFIZER\WYETH~4998218~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0130760	11/15/1999	MS	64.0	64		F	11/08/1999	p/vax pt noticing redness @ Td site;progressed to redness whole upper rt arm & induration & swelling;pt instructed to go see MD;				Y					N	11/01/1999	11/05/1999	4		PUB	PUB	Premarin;Prevacid;vitamins	NONE	allergic to PCN & codeine;only takes premarin, vitamins, prevacid;also an unk medication;	pt exp pain & swelling w/tetanus vax 40yr ago;~ ()~~~In patient	MS99049	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~499823A~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~0967100~2~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0130761	11/15/1999	GA	65.0	65		F	10/07/1999	pt c/o redness & burning to face & chest, rash noted to chest, no c/o itching, red watery eyes, no c/o problems breathing;has had same type of rxn w/niacin in post;pt took DPH;				Y					Y	10/07/1999	10/07/1999	0	NA	PUB	PUB	NONE	NONE	Niacin allergy	NONE~ ()~~~In patient	GA99116	1						1	Chest pain; Conjunctivitis; Lacrimal disorder; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~40118AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454964~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0130762	11/15/1999	GA	54.0	54		F	10/18/1999	pt c/o below site where pneumonia vax given rt deltoid;pt c/o pain @ site in rt arm;warm to touch, no other complaints noticed, redness & swelling began 30min p/vax;				Y					Y	10/15/1999	10/15/1999	0	NA	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	GA99123	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~01988P~7+~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~455754~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0130763	11/15/1999	GA	79.0	78		F	10/20/1999	11 days s/p vax c/o lt arm soreness w/inc in erythema & warmth over past 24hr;area approx 5mm w/various stages of bruising;below area arm warm, erythema, nontender & no swollen to approx 3 1/2-4cm;dx bacterial infect;				Y					Y	10/08/1999	10/19/1999	11		PUB	UNK		stuck ice pickin lt pointer finger;		~ ()~~~In patient	GA99127	1						1	Ecchymosis; Infection; Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02089P~7+~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~CONNAUGHT LABORATORIES~0944780~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0130764	11/15/1999	GA	30.0	30		M	10/26/1999	t102, red skin 9flush bright red);c/o nausea;saw MD;labs drawn;				Y						10/25/1999	10/26/1999	1		PUB	PUB			hx brain tumor-1975	~ ()~~~In patient	GA99140	1						1	Nausea; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~02979P~4~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0130765	11/15/1999	OH	67.0	67		M	11/03/1999	cellulitis rt upper & forearm, red, warm, swollen;pt saw family MD & was put on ATB;				Y					Y	11/01/1999	11/03/1999	2		PUB	PUB	Calan/pravachol	NONE	HTN;high cholesterol	NA~ ()~~~In patient	OH99081	1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4998293~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~458744~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0130766	11/15/1999	CA	12.0	12		M	11/05/1999	p/vax pt itchy then pt became sleepy then p/1hr loss complete consciousness;				Y					Y	10/23/1999	10/27/1999	4	lab tests was transported via abm to hosp;	PUB	PUB	INH;+PPD-arm;	URI-no temp	asthma	NONE~ ()~~~In patient	CA990132	1						1	Pruritus; Syncope	FLU3~MEDEVA PHARMA, LTD.~E29199HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~MERCK & CO. INC.~03630~2~IM~LA~HEP B (RECOMBIVAX HB)~1|MMR~MERCK & CO. INC.~1791H~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0130769	11/15/1999	OK	42.0	42		M	11/09/1999	widespread muscle fasciculations 2 days p/vax has persisted for 2wk;				Y					N	10/25/1999	10/27/1999	2		PVT	PVT				~ ()~~~In patient		1						1	Muscle twitching	FLU3~CONNAUGHT LABORATORIES~U0129AA~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0130772	11/15/1999	AZ	42.0	42		F	11/10/1999	swelling of upper arm pain;				Y					Y	11/03/1999	11/04/1999	1	leukopenia	PVT	PVT		NONE	NKDA;IDDM, leukopenia;	NONE~ ()~~~In patient		1						1	Oedema peripheral; Pain	FLU3~CONNAUGHT LABORATORIES~40132AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0043J~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0130773	11/15/1999	MT	33.0	33		F	11/04/1999	p/vax pt c/o pain p/full dose last year;lt arm red, swollen, sore & c/o tired;DPH given;				Y					Y	10/22/1999	10/24/1999	2		PUB	PUB	NA	NA	NA	NA~ ()~~~In patient		1						1	Asthenia; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4998250~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0130774	11/15/1999	CA	62.0	62		M	10/21/1999	pt returned to clinic w/redness, swelling & pain in rt deltoid;				Y					U	10/20/1999	10/20/1999	0	NONE	OTH	PUB	Theophylline;Ventolin;pred	NONE	asthma	~ ()~~~In patient	CA990135	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~MEDEVA PHARMA, LTD.~E30879KA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~459041~2~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0130777	11/15/1999	AL	66.0	66		F	10/21/1999	10min p/vax onset of lips swelling-hands itching-ears/red & burning;p/arrival @ ER pt had diff breathing;				Y					Y	10/19/1999	10/19/1999	0		PUB	PUB	Bladder med	NONE	NONE	~ ()~~~In patient	AL9921	1						1	Dyspnoea; Ear disorder; Face oedema; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4998232~7+~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0130778	11/15/1999	MI	41.0	41		M	10/25/1999	p/vax noted tongue swelling on 10/9/99;also noted tongue ulcers w/diff swallowing & speaking;saw dentist given antiviral & mouth rinse;sx improving;				Y					Y	10/07/1999	10/09/1999	2		PUB	PVT	Liptol	NONE	allergic to PCN; hypoglycemia	~ ()~~~In patient		1						1	Dysphagia; Speech disorder; Tongue oedema	FLU3~CONNAUGHT LABORATORIES~U0129AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0130783	11/15/1999	NM	39.0	39		M	11/10/1999	chest congestion, coughing, sore throat, burning in nasal passages;				Y					N	11/09/1999	11/09/1999	0	strep-negative;oxygen-dec normal;	OTH	PUB	Ketoconavole;aryhromicin;albuterol;pred;	NONE	scleroderma	~ ()~~~In patient		1						1	Cough; Lung disorder; Pain; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0130784	11/15/1999	CA	53.0	53		F	11/10/1999	redness, edematous;				Y					Y	11/01/1999	11/02/1999	1		PUB	PUB		multiple sclerosis;	multiple sclerosis;	~ ()~~~In patient		1						1	Oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0046AA2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1692H~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0130786	11/15/1999	KY	54.0	54		M	11/05/1999	1 1/2hr p/vax pt had n/v & bad h/a;went to ARNP that day;given pain rx & rx for n/v;c/o feel like has had flu even since got vax;n/v daily, aches, all over, arm hurts where vax given;blister on it & still red;				Y					N	10/14/1999	10/14/1999	0		OTH	PUB		NONE	NONE	~ ()~~~In patient	KY990053	1						1	Headache; Influenza; Injection site hypersensitivity; Injection site pain; Myalgia; Vomiting	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0130790	11/15/1999	GA	50.0	50		F	10/20/1999	p/vax 1 long x 3/4 wide fluid, filled vesicle on posterior aspect of rt deltoid;blister 1 from inj site;began to hurt;									N	10/15/1999	10/15/1999	0		PUB	PUB			NONE	~ ()~~~In patient	GA99118	1						1	Injection site hypersensitivity	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1693H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0130795	11/15/1999	GA	72.0	72		F	10/18/1999	p/vax pt states arm where pneumonia vax given is now red, hot & swollen; temp unk @ present;advised to apply cool compress;APAP given;									Y	10/18/1999	10/18/1999	0	NA	PUB	PUB	Lozal-BP med diuretic	NA		~ ()~~~In patient	GA99124	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~01989P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~463747~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0130796	11/15/1999	GA	59.0	59		F	10/18/1999	p/vax now exp tightness in chest;no s/o chest pain;c/o T100;;									Y	10/14/1999	10/18/1999	4	NA	PUB	PUB	Tomoxil;Glucocol;	NA	astham;breast surgery 3yr ago;	~ ()~~~In patient	GA99125	1						1	Chest pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U011AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~455754~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0130797	11/15/1999	GA	57.0	57		F	10/20/1999	p/vax swelling & redness noted on arm;pain in rt shoulder & back area;pt felt like had a fever but did not take temp;did take APAP;									Y	10/18/1999	10/18/1999	0	NA	PUB	PUB	Clariton-sinus allergies	NONE	NONE	NONE~ ()~~~In patient	GA99126	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~01989P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~455754~2~IM~RA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~7301BA~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0130798	11/15/1999	GA	78.0	78		M	10/21/1999	redness & heat 2-3in above & below rt elbow observed on 10/21/99;									Y	10/19/1999	10/21/1999	2		PUB	PUB	TB test by Parkdale lot# 4525G260 given 10/19/99	NONE	diabetic-reflux;	~ ()~~~In patient	GA99128	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~01989P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~463747~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0130799	11/15/1999	GA	64.0	64		F	10/21/1999	p/vax pt started hacking cough, burning on chest like a bad cold;1hr later ha chill, dizzy & nauseated;cont chills & fever all noc;bad h/a, aching, felt hot;									Y	10/20/1999	10/20/1999	0	NONE	PUB	PUB	Lotril;premarin;Zantac;	NONE	NONE	~ ()~~~In patient	GA99129	1						1	Chest pain; Chills; Cough; Dizziness; Headache; Myalgia; Nausea; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~40990010~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130802	11/15/1999	GA	71.0	71		F	10/22/1999	p/vax pt swollen, blue area over inj site;denies pain;ice pack applied;no WOB or rash, whelp noted;referred to pMD for any other s/s;									Y	10/22/1999	10/22/1999	0	NONE	PUB	PUB	Glucotroli, glucophage;Lipitor	NONE	diabetes	denies~ ()~~~In patient	GA99132	1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema	FLU3~PARKDALE PHARMACEUTICALS~0198P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130803	11/15/1999	GA	65.0	65		M	10/25/1999	p/vax pt was swollen, area red & hard about 2inches in size;redness down & behind the arm;evening had chills, fever, h/a, aching;today still some redness, swelling & soreness but moving down arm;improving;									Y	10/20/1999	10/20/1999	0	NA	PUB	PUB	BP med;vitamins;	NA	inc BP;	NA~ ()~~~In patient	GA99133	1						1	Headache; Injection site hypersensitivity; Injection site oedema; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~02089P~7+~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~456691~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0130804	11/15/1999	GA	64.0	64		F	10/18/1999	swollen rt arm, itching, severe pain started 10/15/99 through 10/18/99; rx w/APAP PRN for pain;DPH, ice & heat alternate;DPH PRN for itching;pt states it was the pneumonia shot that caused the problem;									U	10/13/1999	10/15/1999	2		PUB	PUB				~ ()~~~In patient	GA99134	1						1	Injection site oedema; Injection site pain; Pruritus	FLU3~PARKDALE PHARMACEUTICALS~0279P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1693H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0130806	11/15/1999	GA	71.0	71		F	10/26/1999	weakness in legs x 1 day									Y	10/25/1999	10/26/1999	1		PUB	PUB				~ ()~~~In patient	GA99139	1						1	Myasthenic syndrome	FLU3~PARKDALE PHARMACEUTICALS~02979P~7+~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~0043J~1~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0130808	11/15/1999	GA	70.0	70		F	10/29/1999	LA became severely painful, red & swollen about 3hr p/vax;reports problem worsened during noc;reports severe nausea, no vomiting s/s lasted approx 24hr;									Y	10/27/1999	10/27/1999	0	NONE	PUB	PUB	Coumadin;Prilosec	NONE	HBP, CAD	NONE~ ()~~~In patient	GA99141	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Nausea	FLU3~PARKDALE PHARMACEUTICALS~02289P~6~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1693H~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0130810	11/15/1999	ME	52.0	52		F		tightness in chest, difficulty breathing;blood pressure elevated;p/40min into getting shot 144/98 which is high for pt;better p/40min-1hr feeling better;									Y	10/29/1999	10/29/1999	0	NONE	PUB	OTH	unk	NONE	as child egg sensitivity, asthma now, allergies to cats, dust	~ ()~~~In patient		1						1	Chest pain; Dyspnoea; Hypertension	FLU3~CONNAUGHT LABORATORIES~U0131AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130811	11/15/1999	ID	60.0	60		F	11/03/1999	p/vax tinnitus began @ 1800 that day;									U	10/15/1999	10/15/1999	0		OTH	PUB	Lozol;HRT;Cozaar	Ringing in ears		~ ()~~~In patient		1						1	Tinnitus	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130815	11/15/1999	CA	46.0	46		F	11/05/1999	chest congestion, tightening in throat more noticeable when swallowing, swollen upper lip @ about 1:30PM, eye red & gunky, conjunctivitis;tight throat & swollen lip;									Y	10/22/1999	10/22/1999	0	NONE	PUB	PVT	Vitamins	NONE	NONE	~ ()~~~In patient		1						1	Conjunctivitis; Face oedema; Laryngospasm; Lung disorder; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~U0159AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130816	11/15/1999	IL	60.0	60		F	11/10/1999	4cm erythematous indurated skin rxn devel approx 8-10hr p/vax; pt c/o felt tingly all over;									Y	10/14/1999	10/14/1999	0		PVT	PVT	Prempro;Doxepin Prozac;DTC-antioxidents & grapesee extract;	NONE	cataracts, chronic fatigue synd;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Paraesthesia; Rash	FLU3~CONNAUGHT LABORATORIES~U0110AA~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130817	11/15/1999	IL	61.0	60		F	11/10/1999	8cm erythematous indurated skin rxn day of vax;									Y	10/29/1999	10/29/1999	0		PVT	PVT	Verapamil;HCTZ;Prempro	NONE	HTN, seasonal allergies;	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Paraesthesia; Rash	FLU3~CONNAUGHT LABORATORIES~U163AA~2~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130818	11/15/1999	IL	56.0	56		F	11/10/1999	erythematous indurated skin rxn covering entire deltoid area eval pt 2 day p/vax;skin rxn approx 6cm;it was not documented which arm each vax was given in;									Y	10/15/1999	10/15/1999	0		PVT	PVT	Zyrtec;nasonex;Premarin;Provera;		seasonal allergies	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~U0150AA~3~A~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~458585~1~A~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0130819	11/15/1999	CA	33.0	33		F	10/27/1999	c/o tightness & lumpy feeling in throat, metallic taste in mouth, tip of tongue feels tingling & numb;									U	10/27/1999	10/27/1999	0		PUB	PUB	APAP sinus, zantac	NONE	NONE	~ ()~~~In patient	CA990136	1						1	Dysgeusia; Laryngospasm; Tongue disorder	FLU3~MEDEVA PHARMA, LTD.~E33609KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|MMR~MERCK & CO. INC.~0543J~UNK~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0130820	11/15/1999	CA	54.0	54		M	10/27/1999	p/vax pt awoke  & felt ill-hot/cold flashes;went to work & became incoherent;office sent pt home via taxi;roommate put pt to bed & pt slept several hr;pt got up had water & juice & fell asleep;									Y	10/21/1999	10/22/1999	1	NONE	PUB	PUB	Metroprolog tab;Cardura;Voltran	NONE	HTN, post polio, NKA;	NONE~ ()~~~In patient	CA990133	1						1	Chills; Confusional state; Malaise; Somnolence; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E27979HA~6~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0130823	11/15/1999	MD	46.0	46		F	10/28/1999	pt states awoke 2Am w/hard & fast heartbeat w/heaviness in chest x 6hr;pt described as same as when drink coffee but had no caffeine that day;s/s resolved when sat up;referred to MD;									Y	10/26/1999	10/27/1999	1	NONE	PUB	PUB	maxide;glucophage;Inderal;Prevacid;Celebrex;	NONE	DM, HBP, Endometriosis, inflammation in foot;hiatal hernia & gastric reflus;allergies feldene-swelling of head//face, tongue;merthrolate & neosporin ointment-rash red,-swollen local rxn;	NONE~ ()~~~In patient	MD99025	1						1	Chest pain	FLU3~PFIZER\WYETH~4998225~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130827	11/15/1999	CT	78.0	78		F	10/23/1999	edema & redness of rt arm from the elbow to deltoid the next day p/vax;tx cephalexin;									Y	10/22/1999	10/23/1999	1		OTH	OTH	unk		unk	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4998233~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1585H~1~SC~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0130830	11/15/1999	TX	59.0	59		F	11/10/1999	hives size of orange below inj site;									Y	11/09/1999	11/09/1999	0	NONE	OTH	PUB	Estrogen;Paxil;Celebrex;	NONE	NONE	~ ()~~~In patient		1						1	Injection site mass; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130831	11/15/1999	GA	58.0	58		F	11/10/1999	p/vax pt began to feel nauseated 7 heaved 20min, chills, fever, vomit, diarrhea, aches, pain, hallucinations, T103;spoke to MD by phone;									N	11/02/1999	11/02/1999	0	NONE	PVT	PVT	synthroid	NONE	fibormyalgia, chronic fatigue, spinal stenosis;	pt grandchild exp sx w/DTP;~ ()~~~In patient		1						1	Diarrhoea; Hallucination; Myalgia; Pain; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130832	11/15/1999	AZ	41.0	41		F	11/09/1999	p/vax pt c/o fever 101, chills joint aches & low back pain;pt denied SOB, rash or erythema @ site, chest pain or dysuria;refused to come into town;instructed to have APAP & call if s/s inc;									Y	11/05/1999	11/05/1999	0	+BV, lab WNL;	OTH	PVT	Flagyll;Nalexa;Flovent;	bacteria vaginosis	asthma	~ ()~~~In patient		1						1	Arthralgia; Back pain; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~03179P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130869	11/15/1999	CA	43.0	42		F	11/05/1999	p/vax pt dx w/pneumonia;pt expired on 11/1/99;MD does not feel what occurred is r/t vax;	Y	11/01/1999							N	10/11/1999	10/20/1999	9	autopsy report is pending;	UNK	UNK				~ ()~~~In patient	U199900862	1						1	Pneumonia	FLU3~CONNAUGHT LABORATORIES~U0132AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0130874	11/15/1999	PA	52.0	51		F	11/08/1999	p/vax pt exp anaphylactic rxn consisting of diff breathing, throat closing the pt being very anxious;call made to 911 pt given epi & transferred to hosp;pt released w/in 3 to 4 hr;				Y					U	11/03/1999	11/03/1999	0		UNK	UNK			had prev flu shots, only h/a as a side effect;	~ ()~~~In patient	U199900871	1						1	Anaphylactoid reaction; Anxiety; Dyspnoea; Laryngospasm	FLU3~CONNAUGHT LABORATORIES~U0066DA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0130284	11/16/1999	CA	50.0	49		M	11/03/1999	Working n his backyard when he experienced sudden onset of low back pain. He came to ER walking without problem but developed lower extremity paralysis acutely.				Y	Y	0			U	10/11/1999	10/30/1999	19		OTH	PVT	NONE		Allergic reaction Tetanus - rash, puffiness 1971.			1						3	Back pain; Hypercholesterolaemia; Leukocytosis; Myelitis; Paralysis; Back pain; Paralysis; Back pain; Paralysis	FLU3~CONNAUGHT LABORATORIES~U0109CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0109CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLUX~UNKNOWN MANUFACTURER~U0109CA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Hospitalisation	Influenza
0130838	11/16/1999	MA	32.0	32		F	11/15/1999	pt fell down, felt numb, unable to move, near syncope state, convuls, passing out, hands white, feet numb x 3hr;7 similar episodes diff breathing, walking;dx GBS;60 day follow-up dated 2/15/01 states pt was lightheaded, extreme low blood pressure and fatigue.Annual follow-up dated 1/22/01 states the pt also experiences dizziness and has nerve damage in feet which causes them to be cold.				Y	Y				N	10/07/1999	10/28/1999	21		UNK	UNK						1						1	Asthenia; Convulsion; Dizziness; Dyspnoea; Guillain-Barre syndrome; Hypokinesia; Hypotension; Injury; Neuropathy; Paraesthesia; Paralysis; Peripheral vascular disorder; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0130840	11/16/1999	IL	81.0	81		F		1 day p/vax pt exp dizziness, unbalanced, speech became slurred, incoherent;taken to ER spent the next day in hosp-ran tests to r/o stroke;final dx was rxn to shots;				Y	Y	1			Y	10/28/1999	10/29/1999	1		PUB	PUB				~ ()~~~In patient		1						1	Coordination abnormal; Dizziness; Speech disorder; Thinking abnormal	FLU3~MEDEVA PHARMA, LTD.~E248696A~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~455938~UNK~~LA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~7341AA~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0130844	11/16/1999	NY	78.0	78		M	11/15/1999	broke out on rt side of face;lips swollen;eyes swollen;oozing/swelling to face w/blisters red & infected;				Y						11/10/1999	11/11/1999	1	NONE	PUB	PUB	Carbidopa;Zyprexa;Ferosemide;Sihemet;Cephalxin;Bactromin cream;	NONE	NONE	~ ()~~~In patient		1						1	Dermatitis bullous; Face oedema; Lacrimal disorder; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0130847	11/16/1999	AZ	44.0	44		M	11/05/1999	p/vax consisted of ataxia/dizziness;vertigo, n/v began which lasted 2 days;sl ataxia;remained p/5 days;				Y					Y	10/19/1999	10/22/1999	3	NONE	PUB	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Coordination abnormal; Dizziness; Vertigo; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0145BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0130852	11/16/1999	WA	78.0	78		M	10/20/1999	p/vax pt increased pain sensation in lt upper arm, shoulder & radiation down lt arm, beginning approx 5 days p/vax;noted no discomfort immed p/vax;				Y						10/07/1999	10/12/1999	5		PUB	PUB	Lipicor, vistaril pletel	NONE	peripheral vascular insufficiency, type 2 diabetes;	~ ()~~~In patient	WA991605	1						1	Injection site pain; Pain	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0130853	11/16/1999	HI	48.0	48		M	11/02/1999	approx 10min p/vax pt felt a rush, heart racing, sweating;VS checked in ER;sl pale & diaphoretic;									Y	10/26/1999	10/26/1999	0	NONE	MIL	PUB	NONE	NONE	NONE	~ ()~~~In patient	HI9909	1						1	Hyperhidrosis; Pallor; Tachycardia	FLU3~PFIZER\WYETH~4998232~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130854	11/16/1999	MA	41.0	41		F	10/27/1999	p/vax feeling nausea, vertigo, dizziness w/h/a;general malaise;bright redness covering upper chest to neck to ears;no hives, no itching;warm to touch;numbness on soles of feet & face;arms had vibrating sensation;pain/red/swollen inj site;									Y	10/20/1999	10/20/1999	0	NONE	OTH	PVT	pt stated non that would cause reaction	NONE	NONE	NONE~ ()~~~In patient		1						1	Dizziness; Headache; Injection site hypersensitivity; Injection site oedema; Injection site pain; Malaise; Nausea; Paraesthesia; Tremor; Vasodilatation; Vertigo	FLU3~CONNAUGHT LABORATORIES~U0110AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130856	11/16/1999	NY	37.0	37		F	11/15/1999	p/vax pt stated arm was itchy & felt like it was spreading;arm appeared erythematous;pt monitored for 30min when started having trouble breathing;911 was called & epi given;pt pulse remained WNL;									Y	10/18/1999	10/18/1999	0	NONE	PUB	OTH	NA			~ ()~~~In patient		1						1	Dyspnoea; Pruritus; Rash	FLU3~PFIZER\WYETH~4998221~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130857	11/16/1999		27.0	27		M	11/15/1999	estimated 30min post vax devel urticaria, flushing & hives;routed from place of work in hosp to ER for tx;										11/12/1999	11/12/1999	0		UNK	UNK			no allergy to eggs or other known contraindication;	~ ()~~~In patient		1						1	Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4998223~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0130861	11/16/1999	AZ	69.0	69		M	11/13/1999	pt began to exp discomfort in upper arm to upper shoulder area;in addition there was a pain that radiated toward cervical spine area;muscle spasm applied heat;rx ibuprophen;									Y	10/23/1999	10/25/1999	2	NONE	PVT	PVT	ASA;folic aicd;vitamin E/C/Placebo;Beta Carotine/Placebo	NONE	degenerative disease;	~ ()~~~In patient		1						1	Back pain; Hypertonia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130862	11/16/1999	LA	63.0	63		F	11/12/1999	arm hurt, swelled & red-temp terrible pain several days;pain resolved but redness persists;									Y	11/09/1999	11/09/1999	0	NONE	PUB	PUB	hydrochlorozide;premarin;dazatec;urso;	NONE	NONE	~ ()~~~In patient	LA991101	1						1	Oedema peripheral; Pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0130883	11/18/1999	KY	6.0	6		M	10/25/1999	p/vax lt eyelid drooping, sleepy;saw MD c/o lt side weakness, h/a;adm to ICU @ local hosp;transferred to hosp;dx stroke;MRI showed large infarct rt middle cerebral artery;disch home;11/12/99 pt doing well;plan: poss bone marrow transplant					Y	14			Y	10/21/1999	10/22/1999	1		PUB	PUB		NONE	sickle cell	NONE~ ()~~~In patient	KY990058	1						1	Cerebral infarction; Cerebrovascular accident; Eyelid ptosis; Headache; Laboratory test abnormal; Myasthenic syndrome; Somnolence	FLU3~PARKDALE PHARMACEUTICALS~03179P~2~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0130884	11/18/1999	MD	35.0	34		F	11/12/1999	p/vax pt devel generalized aching back & neck & h/a;numbness started in hands & feet, progressed to painful paresthesia & hyperesthesia to groin & shoulder bilat;still hosp;60 day follow-up dated 09/19/00 states final diagnosis is polyradiculopathy. Annual follow-up dated 12/8/00 provided no additional data.				Y	Y				N	10/28/1999	11/06/1999	9	CSF 11/11/99 RBC 24, WBC 0, portein 70, glucose 71;	OTH	PVT	NONE	cold-no fever	allergic to sulfa & mushrooms;remote cholecystectomy;appendectomy;C/S x2;blood in stool;migraines			1						1	Back pain; CSF test abnormal; Colitis; Guillain-Barre syndrome; Headache; Hyperaesthesia; Neck pain; Neuropathy; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~U0156AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0130885	11/18/1999	CA	49.0			U	11/17/1999	p/vax exp acute lower back & leg pain;onset occurred p/20min;to ER, able to walk w/ one assist; within one hour paralyzed from waist down; tests reveal healthy, normal person w/ no apparent cause. Annual FU: transverse myelitis at T8/9 level. Paralysis is permanent.				Y	Y			Y	U	10/11/1999	10/30/1999	19	MRI, CT Scan, Lumbar Puncture, EKG, CT scan of pelvis, abd, lumbar spine, all relevant blood work & various tests;	OTH	PVT	NONE	NONE	tetanus vax-rash & puffiness occured;			1						1	Back pain; Myelitis; Pain; Paralysis	FLU3~CONNAUGHT LABORATORIES~U0109CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0130890	11/18/1999	MA	50.0	50		M	10/14/1999	p/vax pt w/flu sx, aches, h/a, rt arm swollen, pain, muscle aches; sl improved 10/8/99 coached child game;10/9/99 travel from home-elev temp, pain rt arm;to ER-motrin; in evening had sz, T107, hosp workup				Y	Y	3			Y	10/05/1999	10/07/1999	2	spintal tap x2;CAT Scan;blood, urine &  stool cult;echo-(heart murmur);	PUB	PUB		had h/a	asthma	~ ()~~~In patient	MA9915	1						1	Convulsion; Influenza; Malaise; Myalgia; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0107AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1095H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0130891	11/18/1999	MA	9.0	9		F	10/13/1999	body ache?;Bell's palsy; ascending paralysis, paresthesia, numbness;60 day follow-up dated 2/21/01 provided states that the pt had Guillain Barre which is most resolved with mild weakness. Annual follow-up dated 12/12/00 pt still has mild residual weakness.					Y				N	09/30/1999	10/04/1999	4	lyme test negative;+ CSF  protein;	PVT	PUB	ventolin/flovent	?cold	asthma			1						1	Asthenia; CSF test abnormal; Facial palsy; Guillain-Barre syndrome; Myalgia; Paraesthesia; Paralysis	FLU3~CONNAUGHT LABORATORIES~U0107AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0130893	11/18/1999	NJ	49.0	49		M		1 day p/vax pt had h/a & face turned red;went to ER;rx cortisone & lidocaine;still has rash;				Y						11/02/1999				UNK	UNK		NONE		NONE~ ()~~~In patient		1						1	Headache; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0106EA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0130895	11/18/1999	KY	71.0	71		F	10/22/1999	dizziness, weakness, SOB, hoarseness;pt saw MD & put on keflex;				Y					Y	10/19/1999	10/20/1999	1		PUB	PUB		NONE	parkinson's disease;	~ ()~~~In patient		1						1	Asthenia; Dizziness; Dysphonia; Dyspnoea; Asthenia; Dizziness; Dysphonia; Dyspnoea	FLU3~PFIZER\WYETH~4998236~5~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4998236~5~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0130895	11/18/1999	KY	71.0	71		F	10/22/1999	dizziness, weakness, SOB, hoarseness;saw MD & put on Keflex;				Y					Y	10/19/1999	10/20/1999	1		PUB	PUB		NONE	parkinson's Disease	~ ()~~~In patient	KY990055	1						2	Asthenia; Dizziness; Dysphonia; Dyspnoea; Asthenia; Dizziness; Dysphonia; Dyspnoea	FLU3~PFIZER\WYETH~4998236~5~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4998236~5~~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0130907	11/18/1999	NC	14.0	14		F	10/29/1999	pt seen 1sx w/pericarditis, pruritus & costochondritis;ER visit x 2 10/21/99;MD visit 10/22/99;				Y					U	10/18/1999	10/20/1999	2	CXR, echocardiagram;EKG	PVT	PVT				~ ()~~~In patient	NC99088	1						1	Collagen disorder; Pericarditis; Pleural disorder	FLU3~CONNAUGHT LABORATORIES~U0132AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0130909	11/18/1999	MA	62.0	62		F	10/14/1999	p/vax rt arm swollen-hot all way to elbow-pain;to ER given ATB x 7 days;				Y					Y	10/07/1999	10/08/1999	1		PUB	PUB	Prempro	NONE	nONE	NONE~ ()~~~In patient	MA9914	1						1	Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0107AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1095A~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0130910	11/18/1999	KY	66.0	66		F	10/19/1999	rash over 75% of body (onset 10/14/99);c/o itching;seeing MD on 10/19/99;									Y	10/13/1999	10/14/1999	1		PUB	PUB			allergic to codeine, morphine & sulfa drugs	~ ()~~~In patient	KY990054	1						1	Pruritus; Rash; Pruritus; Rash	FLU3~PFIZER\WYETH~4998236~7+~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4998236~7+~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0130910	11/18/1999	KY	66.0	66		F	10/19/1999	rash over 75% of body (onset 10/14/99);c/o itching;seeing MD on 10/19/99;									Y	10/13/1999	10/14/1999	1		PUB	PUB			allergic to codeine, morphine & sulfa drugs;	~ ()~~~In patient		1						2	Pruritus; Rash; Pruritus; Rash	FLU3~PFIZER\WYETH~4998236~7+~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4998236~7+~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0130914	11/18/1999	NC	49.0	49		F	11/02/1999	became immed lightheaded & dizzy p/vax;observed x 30min in occupational hlth services office w/no other adverse affects;										11/01/1999	11/01/1999	0		UNK	UNK				~ ()~~~In patient		1						1	Dizziness	FLUX~UNKNOWN MANUFACTURER~4998231~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130915	11/18/1999	CT	43.0	43		M	11/16/1999	c/o h/a, nausea & body aches onset 30 hr p/vax;sx persisted x <24hr & resolved w/o med tx or further problems;									Y	10/04/1999	11/05/1999	32	NONE	OTH	PVT	NONE	NONE	hayfever-type allergies;	~ ()~~~In patient		1						1	Headache; Myalgia; Nausea	FLU3~CONNAUGHT LABORATORIES~U0067AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130927	11/18/1999	KY	40.0	40		F	11/15/1999	approx 1hr p/vax pt reported itching & onset was 15min p/inj was flushed, fine red rash about chest, neck, arms;DPH given;BP 142/110, P104, R20;									Y	11/05/1999	11/05/1999	0		PUB	UNK	Tegretol daily past 4-5 years;	NONE	NONE	NONE~ ()~~~In patient	KY990056	1						1	Hypertension; Pruritus; Rash; Tachycardia; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~00199P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130929	11/18/1999	MO	31.0	31		F	11/01/1999	p/vax pt devel local rxn;pt w/ 3-4inch long red raised area @ the inj site;area was hot to touch & arm ached;to MD put on ATB;									Y	10/27/1999	10/28/1999	1	NONE	OTH	PVT	claritin & prinerin		allergies	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0129AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130932	11/18/1999	MA	48.0	48		F	10/05/1999	significant pain radiating from lt deltoid to elbow of lt arm;hives & pruritus between clavicles;phoned MD who ordered DPH;p/1 dose sx subsided;									Y	10/04/1999	10/04/1999	0		OTH	PUB		NA	NKA	~ ()~~~In patient		1						1	Injection site pain; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0107AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130947	11/19/1999	MO	51.0	51		F	11/03/1999	w/in about 1min of vax pt  c/o funny taste;in about 2min pt was getting hoarse & said throat felt like it was swelling;gave 2 DPH & to ER;				Y					Y	11/03/1999	11/03/1999	0		PUB	PUB			allergic to iodine	~ ()~~~In patient	MO99047	1						1	Dysgeusia; Dysphonia; Laryngospasm	FLU3~CONNAUGHT LABORATORIES~U0132AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0130948	11/19/1999	MO	22.0	22		F	11/02/1999	p/approx 10min pt very cold, dizzy, weak;EMS personnel were @ the scene & began monitoring pt;color pale, HR 110-120, hands icy cold;throat felt tight & began to get anxious;given epi & taken to ER;				Y					Y	11/02/1999	11/02/1999	0	unk	PUB	PVT	unk	NONE	Nubain	NA~ ()~~~In patient	MO99046	1						1	Asthenia; Chills; Dizziness; Laryngospasm; Pallor; Tachycardia	FLU3~CONNAUGHT LABORATORIES~U0155AA~2~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0130956	11/19/1999	MI	49.0	49		M	11/16/1999	lateral aspect lt upper arm w/large area of dermal erythema, distal to inj site;skin mildly warm;									U	11/11/1999	11/12/1999	1		PVT	PVT	synthroid	NONE	thyroid cancer history	pt mom exp exn 11/9/99 @ age 70 w/pneumonia vax dose 2;~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0163AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466445~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0130957	11/19/1999	NC	47.0	47		F	11/02/1999	p/vax area was swollen immed larger than a tennis ball;pt became flushed & jittery;was transported by wheel chair to hosp;developing ascending hives, both arms, chest & up neck;felt faint;										11/01/1999	11/01/1999	0		UNK	UNK			hx of allerty to other substances;	~ ()~~~In patient		1						1	Agitation; Dizziness; Injection site mass; Injection site oedema; Urticaria; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~4998231~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130958	11/19/1999	AZ	35.0			F	11/01/1999	inj site indurated, edematous, reddened;pt c/o weakness, nausea,cough, runny nose;site returning to nl size on 3rd day, constitutional sx remain but are less virulent;										10/29/1999	10/29/1999	0	NA	UNK	UNK			past hx of mult allergens;	~ ()~~~In patient		1						1	Asthenia; Cough; Injection site hypersensitivity; Injection site mass; Injection site oedema; Nausea; Rhinitis	FLU3~CONNAUGHT LABORATORIES~U0159AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0130959	11/19/1999	MA	68.0			F	11/16/1999	pt exp an elevated INR p/vax;pt INR were w/in nl range prior to vax;when checked on 11/10/99 INR was 69;MD stopped warfarin for 3 days;2nd day INR dec to 4.8 or 4.9;did not have the values for the subsequent INR tests;										10/29/1999	11/10/1999	12	INR 69;	UNK	UNK	Fosamax, Estrogen patch, multivitamin, itamin E;warfarin;does not use other dietary or herbal supplements;		allergies to thorazine (given in error in place of Dramamine) & ampicillin;type II diabetes-controlled, not on any meds @ present;hx of kidney stones;thinks may have lupus but has not been given this dx;	~ ()~~~In patient		1						1	Red blood cell sedimentation rate decreased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0130963	11/22/1999	VA	57.0	57		F	10/12/1999	pt c/o pain, red, hot arm that lasted 4 days;pt recovered;									Y	10/01/1999	10/02/1999	1	unk	PVT	OTH	unk	unk	unk	NONE~ ()~~~In patient	FLU1061099	1						1	Pain; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~01889P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130964	11/22/1999	TX	40.0	40		F	10/13/1999	reported arm red & warm to touch (local area only) & a feel low as if coming down w/flu last approx 3-4 days;pt stated arm was fire engine red & hot & felt chills over rest of body;									Y	10/01/1999	10/02/1999	1	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	FLU1071099	1						1	Chills; Influenza; Injection site hypersensitivity	FLU3~PARKDALE PHARMACEUTICALS~3079P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130965	11/22/1999	OH	53.0	53		F	10/13/1999	pt devel redness, edema, warmth & pain shooting up shoulder & down arm, erythema from 15025mm reported by school nurse;									Y	10/06/1999	10/06/1999	0	unk	OTH	OTH	unk	NONE	unk	NONE~ ()~~~In patient	FLU1081099	1						1	Oedema; Pain; Rash; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02779P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130966	11/22/1999	OH	48.0	48		F	11/04/1999	redness, edema, warmth & pain shooting up shoulder & down arm;erythema from 15-25mm;									U	10/06/1999	10/06/1999	0	unk	OTH	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	FLLU1091099	1						1	Oedema; Pain; Rash; Vasodilatation; Oedema; Pain; Rash; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02779P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~02779P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~3	USA		Influenza
0130966	11/22/1999	OH	48.0	48		F	11/08/1999	pt devel redness, edema, warmth & pain shooting up shoulder & down arm;erythema from 15-25mm;									U	10/06/1999	10/06/1999	0	unk	OTH	OTH	unk	NONE	NONE	unk~ ()~~~In patient	FLU1171199	1						3	Oedema; Pain; Rash; Vasodilatation; Oedema; Pain; Rash; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02779P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~02779P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~3	USA		Influenza
0130967	11/22/1999	OH	49.0	49		F	11/04/1999	pt devel redness, edema, warmth & pain shooting up shoulder & down arm;erythema from 15-25mm;									U	10/06/1999	10/06/1999	0	unk	OTH	OTH	unk	NONE	NONE	NONE~ ()~~~In patient	FLU1101199	1						1	Oedema; Pain; Rash; Vasodilatation; Oedema; Pain; Rash; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02779P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~02779P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~3	USA		Influenza
0130967	11/22/1999	OH	49.0	49		F	11/08/1999	pt devel redness, edema, warmth & pain shooting up shoulder & down arm;erythema from 15-25mm;									U	10/06/1999	10/06/1999	0	unk	OTH	OTH	unk	NONE	NONE	NONE~ ()~~~In patient	FLU1161199	1						3	Oedema; Pain; Rash; Vasodilatation; Oedema; Pain; Rash; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02779P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~02779P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~3	USA		Influenza
0130968	11/22/1999	OH	53.0	53		M	11/05/1999	pt devel redness, edema, warmth & pain shooting up shoulder & down arm;erythema from 15-25mm;									U	10/06/1999	10/06/1999	0	unk	OTH	UNK	unk	NONE	NONE	NONE~ ()~~~In patient	FLU1111199	1						1	Oedema; Pain; Rash; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~0277P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130971	11/22/1999	CA	47.0	47		F	11/10/1999	stinging rt arm crease-red raised area @ inj site;went home hr p/inj c/o skin sweaty, nauseated, sleepy, tired, h/a, vision doubled & fever;drank 15 or more glasses of H20;sweats & extreme arm pain, weakness in arm & under arm pain & tender									Y	10/13/1999	10/13/1999	0	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	FLU2021199	1						1	Asthenia; Diplopia; Headache; Hyperhidrosis; Hypotonia; Injection site hypersensitivity; Nausea; Pain; Pyrexia; Somnolence	FLU3~PARKDALE PHARMACEUTICALS~03179P~1~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1339H~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0130972	11/22/1999	CA	47.0	47		F	11/10/1999	10/13/99 nausea, lethargic, h/a, tired;T102;vomiting;3 episodes & red raised site 7-8inches long, 5-6 inches across oval shaped under arm & whole upper arm tend to touch w/heaviness & major discomfort;could not work for 2 days d/t rxn;								Y	Y	10/13/1999	10/13/1999	0	NONE	PVT	PVT	Verpamil, Prozac, Premarin;	NONE	hayfever, migraines;	NONE~ ()~~~In patient	FLU2031199	1						1	Asthenia; Headache; Injection site hypersensitivity; Myasthenic syndrome; Nausea; Pain; Pyrexia; Somnolence; Vomiting	FLU3~PARKDALE PHARMACEUTICALS~03179P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1339H~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0130973	11/22/1999	CA	58.0	58		M	11/11/1999	lt arm swelled 2 times nl size-heaviness, restless during noc, fever, h/a, all over lousy feeling, loss of appetite & very painful lt arm;Md arm still quit swollen & weak & not nl self;									N	10/13/1999	10/13/1999	0	NONE	PVT	OTH	Prilosec, Verpamil	NONE	NONE	NONE~ ()~~~In patient	FL72041199	1						1	Anorexia; Asthenia; Headache; Malaise; Myasthenic syndrome; Nervousness; Oedema peripheral; Pain; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~03179P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1339H~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0130974	11/22/1999	NC				U	11/11/1999	p/vax pt c/o diffuse myalgias & arthralgias, most prominent in the low back & thighs;pt had chills, no know fever, no rash, nausea, vomiting;									U	10/15/1999	10/15/1999	0	unk	UNK	UNK	unk	unk	unk	unk~ ()~~~In patient	FLU2061199	1						1	Arthralgia; Chills; Myalgia	FLU3~PARKDALE PHARMACEUTICALS~1889P~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130975	11/22/1999					U	11/11/1999	reported an literature article meningoencephalitis;													unk	UNK	UNK	unk	unk	unk	unk~ ()~~~In patient	FLU2071199	1						1	Encephalitis	FLU3~PARKDALE PHARMACEUTICALS~~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130976	11/22/1999	CA	44.0	44		F	11/12/1999	ringing in both ears p/vax;pt cont to have ringing in ear;									Y	09/29/1999	09/29/1999	0	unk	PVT	PVT	NONE			NONE~ ()~~~In patient	FLU2081199	1						1	Tinnitus	FLU3~PARKDALE PHARMACEUTICALS~03079P~1~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130977	11/22/1999	TX	33.0	33		F	11/12/1999	severe rxn w/itching, wheal all over trunk & back;went to ER where given adrenalin;				Y					Y	10/18/1999	10/18/1999	0	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient	FLU2091199	1						1	Pruritus; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~03079P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0130978	11/22/1999	GA				F	11/12/1999	p/vax pt dx w/Bell Palsy;									N	10/15/1999	10/15/1999	0	unk	OTH	OTH	unk	unk	unk	NONE~ ()~~~In patient	FLU2111199	1						1	Facial palsy	FLU3~PARKDALE PHARMACEUTICALS~0317P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130979	11/22/1999	OK	41.0	41		M	11/15/1999	shooting pain lt arm when raise arm & cannot lay on arm;cont take motrin;pain lasted x 4 days;				Y					Y	10/12/1999	10/12/1999	0	NONE	PVT	OTH	Zoloft, Vitamins	NONE	NONE	NONE~ ()~~~In patient	FLU2131199	1						1	Pain	FLU3~PARKDALE PHARMACEUTICALS~02779P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0130980	11/22/1999	WI	52.0	51		F	11/15/1999	reported double vision, h/a, dizziness that lasted for 24hr;									Y	10/28/1999	10/28/1999	0	NONe	PVT	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	FLU2141199	1						1	Diplopia; Dizziness; Headache	FLU3~PARKDALE PHARMACEUTICALS~02089P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130981	11/22/1999	NY	25.0	25		F	11/15/1999	p/vax lt arm was edematous from upper shoulder to elbow;									Y	10/14/1999	10/18/1999	4	NONE	PVT	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	FLU2151199	1						1	Injection site oedema	FLU3~PARKDALE PHARMACEUTICALS~0297P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130982	11/22/1999	NY				F	11/16/1999	p/vax pt exp edematous from upper shoulder to elbow;									Y	10/14/1999	10/18/1999	4	NONE	PVT	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	FLU2161199	1						1	Injection site oedema	FLU3~PARKDALE PHARMACEUTICALS~02979P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130983	11/22/1999	FL	48.0			M	11/16/1999	p/vax pt pupils were red, dilated & painful;pt recovered p/12hr;									Y		10/29/1999		NONE	PVT	OTH	unk	unk	unk	unk~ ()~~~In patient	FLU2171199	1						1	Mydriasis; Pain; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02189P~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130984	11/22/1999	IL	93.0	93		F	11/17/1999	p/vax WBC, liver enzyme, bilirubin, SGOT & allergic rxn & felt tired & weak;went to ER & hosp for couple days;				Y	Y				Y	10/15/1999	10/16/1999	1	NONE	PVT	OTH	unk	NONE	NONE	NONE~ ()~~~In patient	FLU2181199	1						1	Aspartate aminotransferase increased; Asthenia; Hepatic function abnormal; Hyperbilirubinaemia; Hypersensitivity; Leukocytosis	FLU3~PARKDALE PHARMACEUTICALS~~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0130985	11/22/1999	CO				F	11/16/1999	p/vax pt became ill w/sharp burning pain in lt lower quadrant of abd, inc temp 102.4, chills, unable to get warm was placed in hosp;tx of flagyl & Cipro;began strawberry rash over most of body;					Y				Y	10/07/1999	10/15/1999	8	10/27/99 had CBC, lytes, UA, Epstine Barr, stool spec	PVT	OTH	NONE	NONE	NONE	NONE~ ()~~~In patient	FLU2191199	1						1	Abdominal pain; Chills; Pyrexia; Rash	FLU3~PARKDALE PHARMACEUTICALS~~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0130989	11/22/1999	TN	69.0	69		F	10/27/1999	p/vax pt w/local rxn, bruise 1/2 dollar size, redness extending 4 down from site;				Y					Y	10/11/1999	10/12/1999	1	NA	PVT	OTH		NONE	NONE	NA~ ()~~~In patient	TN99042	1						1	Ecchymosis; Injection site hypersensitivity; Injection site reaction	FLU3~PARKDALE PHARMACEUTICALS~02679P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~463017~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0130997	11/22/1999	PA	74.0	74		F	11/16/1999	p/vax pt w/pain in rt upper arm & deltoid insertion 3-4 distal to immun site;local heat advised;referred to orthopedic MD;rt shoulder pain questionable r/t flu vax;lab work pending;				Y					U	10/18/1999	10/27/1999	9	ANA-negative;CPK-WNL;sed rate-68;Aldolase-pending;orthopedic consult;	PVT	PVT	Verapamil SR;Ativan;Coumadin;	NONE	hyperlipidemia;NIDDM;mitral valve replacement;IBS;s/p subarachnoid hem;allergies codeine;	~ ()~~~In patient		1						1	Injection site pain; Pain; Red blood cell sedimentation rate increased	FLU3~PFIZER\WYETH~4998226~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0131001	11/22/1999	SD	38.0	37		F	11/01/1999	p/vax pt devel some soreness in lt arm;arm remained sore but pain started on 5th day in muscle above bicep;pain progressed to whole arm & into neck in back of neck;pain head & wrist & muscle jerking;poss nerve was hit by needle per MD;				Y					U	10/14/1999	10/15/1999	1		UNK	UNK	Started O's alesse 10/25;	NONE	NONE	NONE~ ()~~~In patient	SD99038	1						1	Hypokinesia; Injection site pain; Muscle twitching; Myalgia; Neck pain; Neuralgia; Pain	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0131003	11/22/1999	SC	70.0	70		M	11/05/1999	noticed swelling from rt elbow to hand around 8PM the evening p/vax;pt came to hlth dept around 10:00 11/4/99 to have nurse look at swelling;referred to PMD for marked swelling rt arm from hand to elbow, redness, denies pain or fever;				Y					U	11/02/1999	11/02/1999	0		PUB	PUB		NONE	SOB secondary to resp problem	~ ()~~~In patient	SC99074	1						1	Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0131AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1094H~2~~RA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~7341AA~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0131009	11/22/1999	CA	55.0	55		M	11/19/1999	p/vax pt immediately became ill like had the flu;pt does not like hosp;									N	11/08/1999	11/10/1999	2	?	UNK	UNK		NONE		NONE~ ()~~~In patient		1						1	Influenza	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0131011	11/22/1999	TN	54.0	54		F	10/27/1999	approx 20min p/vax pt c/o moderate itching, swelling & warmth @ inj site;exam show  approx 2cm diameter red raised area, warm tot ouch;moderate itching;DPH given;ice pack to site itching resolving;redness dec;									Y	10/27/1999	10/27/1999	0	NA	PUB	OTH	NONE	NONE	hx allergic to seafood/shrimp;NKDA;	NONE~ ()~~~In patient	TN99043	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0131AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131018	11/22/1999	MS	31.0	31		F	11/04/1999	autoimmune response to the flu vax;stiff, achy joints & bones mostly in lower extremities;low temp from 99.5 to 100.5;pt felt a detached feeling- i.e. altered awareness;fatigue was present;									U	10/22/1999	10/24/1999	2	all blood work nl  x/PTH needed adjustment from .175 to .200;recent PTH test indicated the PTH was nl 11/1/99;	OTH	OTH	Synthroid .175	NONE	NONE, only thyroid disorder controlled by medicine	NONE~ ()~~~In patient	MS99051	1						1	Arthralgia; Asthenia; Immune system disorder; Pyrexia; Thinking abnormal	FLU3~PFIZER\WYETH~4998232~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131020	11/22/1999	VA	74.0	74		F	11/18/1999	lt migratory polyarthralgias & myalgias x 2-3 wk;afeb;vital signs stable;tx large joint inj, PO pred; NSAIDS & Darvocet;									Y	10/29/1999	11/01/1999	3	lyme titers negative;ANA negative;CBC WNL;RF negative;uric acid WNL;ESR 25 (0-30);	PVT	UNK	vitamin E	NONE	NONE	NA~ ()~~~In patient		1						1	Arthralgia; Myalgia	FLU3~MEDEVA PHARMA, LTD.~E29199HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0131023	11/22/1999	WI	55.0	55		M	11/11/1999	p/vax pt devel large egg size lump @ inj site;warm & tender;had subsided by the time wife notified the clinic;									Y	11/05/1999	11/05/1999	0	NONE	PVT	PVT	NONE	NONE	NKDA	unk~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~CONNAUGHT LABORATORIES~U0126FA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131024	11/22/1999	TX	46.0	46		F	11/04/1999	p/vax pt began having chills, fever, flushed warm to touch, (did not check temp) had taken APAP;site of pneumovax inj began to swell, redness & very painful from shoulder to elbow;heart racing & chest pain;									Y	10/29/1999	10/29/1999	0	NONE	PUB	PUB	Vitamins;Paxil;Inhalers PRn;Accolate BID;ASA;Trazadone;	NONE	asthma, angina	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia; Tachycardia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0165AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1247H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0131026	11/22/1999	PA	32.0	32		F	11/16/1999	rash & hives on upper thighs & abd;resolved p/96 hours;									Y	11/11/1999	11/12/1999	1		OTH	PUB		NONE	NONE	~ ()~~~In patient		1						1	Rash; Urticaria	FLU3~PFIZER\WYETH~4998220~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131027	11/22/1999	LA	40.0	40		F	11/03/1999	rash w/itching on chest, arms, breast, neck & face which devel approx 24hr p/vax;tx Celestone, DPH;									Y	10/26/1999	10/27/1999	1	NA	PVT	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~U0158AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131033	11/22/1999	KS	50.0	50		F	11/18/1999	local rxn lt deltoid w/3cm erythema, induration t & 2cm;fluid filled bullae @ inj site;									U	11/15/1999	11/16/1999	1	NONe	OTH	PVT	NONE	sinusitis	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~U0165AA~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131036	11/22/1999	AZ	72.0	72		M	11/09/1999	rt arm hot, swollen, hard;unable to move arm @ all;11/8/99 movement improved 9entire upper arm), erythema;11/9/99 erythema edema moved to lower rt arm;movement improved;									N	11/06/1999	11/07/1999	1		OTH	OTH	Glucophage, Coumadin, ASA, Lanoxin, Lipitor, Avandia, Glynase, Zantac	well	diatetic-no allergies	NA~ ()~~~In patient	AZ9927	1						1	Hypokinesia; Injection site hypersensitivity; Injection site mass; Injection site oedema; Oedema peripheral; Rash; Hypokinesia; Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~~RA~PNEUMO (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~~2~~RA~PNEUMO (NO BRAND NAME)~2	USA		Influenza
0131386	11/22/1999	OH	29.0	29		F	11/17/1999	beneath tongue swollen face puffy audible wheezing;				Y					Y	10/27/1999	10/27/1999	0	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	OH99083	1						1	Asthma; Face oedema; Tongue oedema	FLU3~CONNAUGHT LABORATORIES~U0131AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0129549	11/23/1999	IL				U	10/25/1999	hives/rash;pt itch;pink raised bumps;pt painful;										09/22/1999	09/23/1999	1		UNK	UNK				~ ()~~~In patient		1						2	Dermatitis bullous; Rash; Pain; Pruritus; Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0131045	11/23/1999	FL	85.0	85		F		p/vax pt c/o T103.8 & shaking chills;refused hosp adm;T104.6 R;adm to hosp;10/14/99 CXR showed ARDS & pneumonia;pt placed on ventilator;devel DIC;pt expired 10/25/99;	Y	10/25/1999	Y	Y	Y	12			N	10/05/1999	10/12/1999	7	10/25/99 positive viral cult for influenza A from a bronchial washing;	PVT	UNK		chronic vertigo	HTN;Hypothyroidism;Iron def anemia;	NONE~ ()~~~In patient		1						1	Coagulopathy; Hypoxia; Infection; Pneumonia; Pyrexia; Respiratory disorder	FLU3~PFIZER\WYETH~49998293~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0131046	11/23/1999	WI	43.0			M	11/19/1999	p/vax pt started getting flush & c/o SOB & chest tightness;code 4 called; pt given 2 shots of epi, 2NTG tablets sublingual, IV fluids; pressure low;c/o itching all over & nausea but no vomiting or abd pain;MI r/o and pt d/c p/ several hr;			Y		Y					10/21/1999	10/21/1999	0		UNK	UNK		allergies were bad the week a/ vax and pt had inc SOB the noc a/ vax	pt severe allergies, asthma;	~ ()~~~In patient		1						1	Chest pain; Condition aggravated; Dyspnoea; Hypotension; Hypoxia; Nausea; Pruritus; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0131047	11/23/1999	VA	73.0			M	10/22/1999	p/vax pt devel sx of GBS;pt did have a viral infect 7 days prior to onset of sx;pt recv IVIG & recovered;					Y				Y	10/16/1999	10/16/1999	0		UNK	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0131048	11/23/1999	VA	62.0			F	11/15/1999	pt recv vax 7 days prior to onset of sx;1wk prior to flu shot had viral URI;pt did not require tx w/IVIG;pt recovered & was discharged home;					Y				Y	11/06/1999	11/06/1999	0	NONE	UNK	UNK			asthma;bladder cancer;	~ ()~~~In patient		1						1	Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0131050	11/23/1999	MI	74.0	74		M	10/29/1999	p/vax arm red/inflamed & swollen from elbow to shoulder w/reduced mobility;seen in clinic;some improvement;				Y						10/25/1999	10/26/1999	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MI9911	1						1	Hypokinesia; Injection site hypersensitivity; Injection site inflammation; Injection site oedema	FLU3~PARKDALE PHARMACEUTICALS~02979P~4~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~44645~1~SC~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0131051	11/23/1999	MI	62.0	62		F	11/03/1999	p/vax pt legs & arms felt heavy 48hr p/vax;pt c/o abd cramping & need to sleep all the time;saw MD;told had rxn to flu shot;				Y					Y	10/12/1999	10/14/1999	2	NONE	PUB	PUB	Carduna;Xanax;	NONE	allergy to PCN, Darvon, Procardia & sulfa;	NA~ ()~~~In patient	MI99117	1						1	Abdominal pain; Myasthenic syndrome; Somnolence	FLU3~PARKDALE PHARMACEUTICALS~03179P~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0131052	11/23/1999	MI	52.0	52		F	11/03/1999	p/vax pt woke up Thursday Am w/cough & s/s of asthma exacerbation;10/23 went to MD;required 2 doses of adrenalin in MD office & long term therapy w/pred & inhalers & prescription cough med;				Y					Y	10/20/1999	10/21/1999	1	NONE	PUB	PUB	HRT/Nasorex, allegra, prilosec;	NONE	asthma	~ ()~~~In patient	MI99118	1						1	Asthma; Condition aggravated; Cough	FLU3~PARKDALE PHARMACEUTICALS~03179P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0131053	11/23/1999	MI	11.0	11		F	11/10/1999	arm was red & swollen;in 2 days it extended from the armpit to the elbow;MD prescribed ceftin for 10 days & use of a heating pad;child back in school p/4 days as arm was fully recovered;				Y					Y	10/25/1999	10/26/1999	1	visual exam by MD;	PUB	UNK	Ventolin PRN;asthmacort PRN	NONE	asthma/environmental allergies-mold, etc	NA~ ()~~~In patient	MI99119	1						1	Lymphadenopathy; Oedema peripheral; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~03179P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~461154~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0131055	11/23/1999	MI	68.0	68		M	11/08/1999	p/vax pt c/o arm starting to hurt 11/4/99;seen in clinic 11/5/99;rt arm upper swollen & hard to touch;11/5/99 went to pvt  clinic, told to use warm compressor  11/8/99;arm improving;				Y						10/26/1999	11/04/1999	9		PUB	PUB		NONE		~ ()~~~In patient	MI99122	1						1	Injection site mass; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~U0167AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~UD012AA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0131056	11/23/1999	NY	50.0	50		F	11/02/1999	p/vax pt in rt deltoid @ MD office;rt arm red, swollen, painful;dx superficial cellulitis rt upper arm;tx w/ice & amox;				Y					Y	10/21/1999	10/21/1999	0	NA	PVT	PVT	NA	NONE	NONE	NA~ ()~~~In patient		1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~U0145DA~1~A~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~458743~1~A~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0131060	11/23/1999	UT	65.0	65		F	11/02/1999	lt arm swollen & red, hot to touch;pt felt weak & nervous;no temp;visit to MD recommended;ice pack, claritan & Ibuprofen & DPH;				Y					Y	11/01/1999	11/02/1999	1	NONE	PUB	PUB	Synthroid;Norvas;Prempod hormone;		allegic bees;has high BP-thyroid disorder;	NONE~ ()~~~In patient	UT991837	1						1	Asthenia; Injection site hypersensitivity; Injection site oedema; Nervousness; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~671~7+~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~669~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0131062	11/23/1999	MI	69.0	69		F	11/01/1999	lt arm was sore initially then became swollen & red w/dark red dots throughout;applied ice & epsom salts & is talking APAp;hand hurt 10/31/99;feels better today, but still red & swollen;										10/28/1999	10/29/1999	1		PUB	PUB		NONE	allergy to demerol, motrin some plants	~ ()~~~In patient	MI99109	1						1	Oedema peripheral; Pain; Skin discolouration; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02089P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~CONNAUGHT LABORATORIES~U0012AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0131064	11/23/1999	MI	68.0	68		F	11/08/1999	p/vax pea-sized pimple devel;itchy;scab @ inj site;may have itched the site;rash spread to full length of upper arm-just above elbow elbow;itchy & swollen;hot to touch;sit itchy;									Y	10/15/1999	10/19/1999	4	NONe	PUB	PUB	Pilopine cream;betoptic;synthroid;		hypothyroid;glaucoma;hayfever (no meds);	NONE~ ()~~~In patient	MI99112	1						1	Injection site hypersensitivity; Oedema peripheral; Pruritus; Rash; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~03179P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~CONNAUGHT LABORATORIES~7258BA~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0131065	11/23/1999	MI	51.0	51		M	10/15/1999	c/o itching, swollen, erythematous eyes, hands & feet;rash spread to chest, abd , groin & legs;described rash as raised red bumps;contacted MD;instructed to take OTC antihistamines;									U	10/07/1999	10/10/1999	3	NONE	PUB	PUB	Lipitor;	NONE	NONE	NA~ ()~~~In patient	MI99116	1						1	Face oedema; Oedema peripheral; Pruritus; Rash; Rash maculo-papular	FLU3~PARKDALE PHARMACEUTICALS~03179P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0131066	11/23/1999	MI	50.0	50		F	10/29/1999	rash welts w/much itching over entire body x/face;									Y	10/25/1999	10/27/1999	2	NONE	PUB	PUB	Ziac for HTn	NONE	HTN, NKA	~ ()~~~In patient	MI99121	1						1	Pruritus; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~03179P~6~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0131071	11/23/1999	MO	20.0	20		F	11/16/1999	p/vax pt c/o brief episode of tight breathing;									N	11/09/1999	11/09/1999	0	NONE	OTH	PVT	Orthotricyclen;Ibuporfen PRn	NONE	PCN;	NONE~ ()~~~In patient		1						1	Asthma; Condition aggravated; Dyspnoea	FLU3~CONNAUGHT LABORATORIES~U0163AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131074	11/23/1999	UT	42.0	42		F	11/08/1999	p/vax pt awoke w/horrible h/a & nausea;want to throw up in container @ bedside;must have collapsed there;awoke on floor @ 10AM;crawled to phone p/a few mint of confusion & called a friend for help;dry tinny taste in mouth;cold sweat, achy									Y	11/05/1999	11/06/1999	1		PUB	PUB		NONE	NONE	~ ()~~~In patient	UT991036	1						1	Anorexia; Asthenia; Chills; Confusional state; Diarrhoea; Dry mouth; Dysgeusia; Headache; Hyperhidrosis; Myalgia; Syncope; Vomiting	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0131360	11/24/1999	PA				F	11/19/1999	p/vax pt devel SOB & a cough;pt hosp & dx of extensive bilat pneumonia w/bilat infiltrates made;pt intubated for a wk in ICU & tx w/broad spectrum ATB;unspecified cult & bronchoscopy negative;pt recovered;			Y	Y	Y				Y	10/25/1999	11/01/1999	7	culture NOS negative-negative;Bronchoscopy-negative;	OTH	OTH	unk	unk	unk		6014118NOV199	1						1	Cough; Dyspnoea; Hypoxia; Pneumonia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0131361	11/24/1999	FL				F	11/19/1999	p/vax pt felt ill & devel malaise & weakness;pt seen by MD who performed unspecified tests leading to a dx of cancer of the kidney;pt had questionable allergy to gentamicin;				Y					U	11/01/1996	11/01/1996	0		OTH	OTH	unk	unk	drug hypersensitivity		5892117NOV199	1						1	Asthenia; Malaise; Neoplasm malignant	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0131368	11/24/1999	VA	26.0	26		M	11/24/1999	dizziness, numbness lt side of face;ER dx labyrinthitis, early Bells palsy saw MD believes d/t flu vax;				Y					U	10/29/1999	11/12/1999	14	CT Scan  head-negative;	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Dizziness; Facial palsy; Paraesthesia; Vestibular disorder	FLUX~UNKNOWN MANUFACTURER~4998334~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0131376	11/24/1999	FL	45.0	45		F	11/01/1999	rash under lt breast approx 5PM 10/29/99 using cortisone cream on rash;11/1/99 generalized rash on back, arms, thighs, & palms of hands;pt to see pvt MD 11/1/99;										10/29/1999	10/29/1999	0	NONE	PUB	UNK	Narvasc;	NONE	HTN	~ ()~~~In patient	FL99044	1						1	Rash	FLU3~PARKDALE PHARMACEUTICALS~02189P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0130209	11/26/1999	WY	45.0	45		F	10/28/1999	p/vax pt became dizzy & fell;pt was flushed & felt very weak in upper body;sx lasted until 930PM;no sx next day;									Y	10/22/1999	10/22/1999	0		PUB	PUB	Tegretol, K-dur, Prepopo;Zantac;Lasix;	NONE	blind, depression, mood swings, edema;	~ ()~~~In patient	WY9919	1						2	Dizziness; Injury; Myasthenic syndrome; Vasodilatation; Dizziness; Myasthenic syndrome; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U01328A~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~459837~1~IM~RA~PNEUMO (PNU-IMUNE)~1|FLU3~CONNAUGHT LABORATORIES~U01328A~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~459837~1~IM~RA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0131378	11/26/1999	IA	45.0	45		M	11/24/1999	p/vax pt dx w/acute pancreatitis,azotemia,anemia,leukocytosis, & hypocalcemia.Pt hospitialized & dvlped complications including respiratory insufficiency sec. to abd distention.Pt tx w/multiple IV meds,intubation,thoracentesis. Annual follow-up dated 1/17/01 provided no additional data.					Y				Y	10/27/1999			CXR-pleural effusion,CT of abdomen-pancreatitis,EKG-sinus tachycardia	OTH	PVT	NONE	NONE	NONE			1						1	Anaemia; Blood urea increased; Flatulence; Hypocalcaemia; Leukocytosis; Pancreatitis; Pleural effusion; Respiratory disorder; Tachycardia	FLU3~CONNAUGHT LABORATORIES~U0165AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0131383	11/26/1999	WY	29.0	29		F	11/03/1999	pain & redness on lt arm near & around inj site;seen in ER & put on  IV ATB;CBC & blood cult done;arm was warm & red;pain &  redness spread to armpit & lt side of breast;to ER;T99.5;lt arm was warm to touch;hot & red around inj site;pain;									Y	10/28/1999	10/29/1999	1	Blood culture;CBC;WBC 16,000;	PUB	UNK		NONE	NONE	~ ()~~~In patient	WY9918	1						1	Injection site hypersensitivity; Injection site pain; Leukocytosis; Lymphadenopathy; Oedema; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4998287~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~459837~1~IM~LL~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0131389	11/26/1999	MD	49.0	49		F	11/03/1999	p/vax pt exp swelling of the lips & felt voice changed;lt side of neck became red blotchy;took DPH;				Y					Y	10/21/1999	10/21/1999	0	NONE	PUB	PUB	Estrace, Detrol, other Bp med, name unk (takes occasionally)	NONE	INH, tomatoes, imetrix (IM) anaphylaxic rxn, latex;	NONE~ ()~~~In patient	MD99027	1						1	Dysphonia; Face oedema	FLU3~PARKDALE PHARMACEUTICALS~02979P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0131413	11/26/1999	CA	47.0	47		F	10/21/1999	45mm area of redness, lt deltoid @ inj site warm, red, painful;									Y	10/20/1999	10/20/1999	0	NONe	PVT	PVT	Vasotec;Atenolol;Procarida;Lipitor;Prometrium;Estradion;Folic Acid;Vit E;orlistat;ASA;	NONE	CAD	NONE~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0109BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131430	11/26/1999	NE	43.0	43		F	11/22/1999	p/vax pt devel flu like sx that evening fever, chills, h/a & nausea;cleared w/in 24hr;									Y	10/07/1999	10/07/1999	0		UNK	UNK	unk	NONE	NONE			1						1	Headache; Influenza; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0129AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131437	11/26/1999	WV	60.0	60		M	11/23/1999	rt sided facial paralysis w/generalized weakness;									Y	10/28/1999	11/02/1999	5	CT Scan-head-negative;	PVT	PVT				~ ()~~~In patient		1						1	Asthenia; Facial palsy	FLU3~CONNAUGHT LABORATORIES~U0110AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131443	11/29/1999	SC	82.0	81		M		presented to urgent care 11/3/99 w/over all weakness;adm hosp,  blood transfusion for ongoing anemia then dx w/GBS;had ascending paralysis;tx w/plasmapheresis;has gross muscle movement back but unable to ambulate d/t weakness;hosp again;60 day follow-up dated 09/26/00 provided no additional data. Annual follow-up dated 01/22/01 provided no additional data.				Y	Y	14			N	10/14/1999	11/03/1999	20	LP-elevated protein	MIL	MIL			crohns disease, anemia, renal fail,s/p colon CA			1						1	Anaemia; Asthenia; CSF test abnormal; Condition aggravated; Guillain-Barre syndrome; Hypokinesia; Paralysis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0131448	11/29/1999	NY	33.0	33		M	11/11/1999	muscle spasms, weakness in rt leg; noticed sx worsened; numbness, tingling on both legs;dx myopathy, MS; 60 day follow-up dated 11/6/00 provided no additional data. Annual follow-up dated 1/24/01 states the pt is being treated for demyelination of the spine that was due to the vaccine.			Y	Y				Y	N	10/28/1999	10/30/1999	2	MRI, Neuro MD	OTH	PVT	NONE	NONE	NONE			1						1	Hypertonia; Multiple sclerosis; Myasthenic syndrome; Myopathy; Neuropathy; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~U0169AB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Disabling	Influenza
0131449	11/29/1999	MA	56.0	56		M	11/03/1999	pt was found dead 12.5 days p/vax;	Y	10/24/1999							N	10/11/1999	10/24/1999	13		PUB	PUB	2 types insulin, synthroid, antidepressants-buspar;anapheril, Ritalin, flexaril, melatonin	NONE; blood sugar nl 10/23, 10PM	diabetes (for 37 years), Graves disease (for 20yrs), diabetic depression	none~ ()~~~In patient	MA9924	1						1	Unevaluable event	FLU3~CONNAUGHT LABORATORIES~U011AB~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0131450	11/29/1999	SC	52.0	52		F	11/23/1999	p/vax pt began w/numbness in feet;11/18 dx w/GBS per MD; 60 day follow-up dated 11/6/00 provided no additional data. Annual follow-up dated 1/29/01 provided no additional data.					Y				U	10/28/1999	11/10/1999	13	spintal tap confirmed dx;	UNK	OTH	unk	unk	unk			1						1	CSF test abnormal; Guillain-Barre syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~U0111AB~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0131452	11/29/1999	LA	7.0	7		F	11/15/1999	pt expired 11/7/99-COD accidental asphyxiation d/t lissencephaly, microcephaly;	Y	11/07/1999							N	11/04/1999	11/07/1999	3		PUB	UNK	phenobarbital;	NONE	lissencephaly, microcephaly, sz disorer;	~ ()~~~In patient	LA991103	1						1	Asphyxia; Convulsion; Injury	FLU3~CONNAUGHT LABORATORIES~U0167AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0871H~1~~RL~PNEUMO (PNEUMOVAX)~1	USA	Results in Death	Influenza
0131453	11/29/1999	OH	42.0	42		F	11/15/1999	p/vax pt felt like passing out;arms weak especially rt forearm;stomach cramps w/diarrhea;n/v;bad h/a;pt not totally recovered 1/15/99;dx general malaise, adverse drug rxn;				Y					Y	11/12/1999	11/13/1999	1	glucose 114;creatinine 0.8;BUN 12;Sodium 138;Potassium 3.7;chloride 107;CO2 24;RBC 3.96;Hemoglobin 11.6;HCT 34.3;segs 85.2;lymphocyte 9.2;	UNK	UNK	Mantoux by PMC lot# 251211 given 11/12/99;	NONE	CATS;pollen allergies;		OH99089	1						1	Abdominal pain; Diarrhoea; Headache; Hyperglycaemia; Malaise; Myasthenic syndrome; Syncope; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0144AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0131454	11/29/1999	AR	41.0	40		F	11/03/1999	p/vax pt rt upper deltoid are rt arm site of inj felt numb immed p/vax;rt arm felt very sore & by 12noon rt arm felt achy down to elbow;felt numb sensation from inj site to rt elbow;numbness spreading to rt side of neck down rt forearm;				Y					Y	10/15/1999	10/15/1999	0		PUB	PUB	NONE		NONE	NONE~ ()~~~In patient	AR9945	1						1	Injection site hypersensitivity; Injection site pain; Myasthenic syndrome; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0131456	11/29/1999	TX	49.0	48		M	09/29/1999	p/vax pt rt upper arm & shoulder started hurting;became worse 2mo later;saw MD dx bursitis & given naprosyn & took for 2mo;rt arm hurts to reach upward or behind;rt arm shoulder hurts very badly;dx tendonitis;given med;				Y					N	10/29/1998	11/12/1998	14		PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	TX9935	1						1	Arthralgia; Bursitis; Tendon disorder	FLU3~CONNAUGHT LABORATORIES~0983320~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0131457	11/29/1999	AR	5.0	5		M	11/22/1999	temp x 2hr, swelling @ inj site measuring 2 1/2 x 1 1/2 diameter;tender to touch;rx warm packs & Atarax;no sign of cellulitis;				Y					Y	10/25/1999	10/26/1999	1	NONE	PVT	PUB	Dexadren;vitamin;Albuterol;	pneumonia treated just prior to vax;	reactive airway disease;develop delays, cerebral palsy;	~ ()~~~In patient		1						1	Injection site oedema; Injection site pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~455939~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0131461	11/29/1999	MO	75.0	74		M	11/18/1999	24hr post vax pt began itching in various places & broke out in hives on trunk;				Y					Y	11/16/1999	11/17/1999	1	NONE	UNK	UNK	metopolol;Clayveic;Norvasic;endone	tightness inchest	heart problem/by pass surgery	~ ()~~~In patient		1						1	Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0131462	11/29/1999	AR	66.0	66		F	11/17/1999	flu sx;stuffiness in head, tired, h/a, chills, fever, no energy, sore throat, runny nose;				Y					N	11/04/1999	11/10/1999	6	NONE	PUB	PUB				~ ()~~~In patient		1						1	Asthenia; Headache; Influenza; Pharyngitis; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0131463	11/29/1999	OH	43.0	43		F	11/05/1999	devel swollen joints in hands & knees;eval by orthopedic MD w/? referred to 2nd rxn;no titers drawn;				Y					Y	10/22/1999	10/23/1999	1	x-ray of knee	PUB	PUB			asthma;hx myalgia ?arthritis;	~ ()~~~In patient	OH99082	1						1	Osteoarthritis	FLUX~UNKNOWN MANUFACTURER~U0144AA~1~A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0131475	11/29/1999	ID	28.0	28		F	10/25/1999	9 days p/vax devel rt side face paralysis (Bell's Palsy);				Y						10/15/1999	10/24/1999	9		OTH	PVT	the pill			~ ()~~~In patient	ID99026	1						1	Facial palsy	FLU3~PFIZER\WYETH~4998282~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0131488	11/29/1999	LA	60.0	60		F	11/10/1999	3 days p/vax pt c/o h/a, chills, fever & nausea;went to MD given phenergan suppository & APAP;pt still feeling bad;pt adm to hosp for test;did spinal tap poss infect; 60 day follow-up received on 08/14/00 provided no additional data. 60 day follow-up provided no additional data.				Y	Y					10/01/1999	11/04/1999	34		PUB	UNK		NONE			LA991106	1						1	Headache; Malaise; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0167AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~70871H~1~~RA~PNEUMO (PNEUMOVAX)~1|TD~LEDERLE LABORATORIES~465315~1~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0131490	11/29/1999	MD				M	11/24/1999	2 1/2wk p/vax devel sl larger than quarter size red area w/some vesicles w/itching feeling;									Y	11/03/1999	11/21/1999	18	NONe	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus	FLU3~PARKDALE PHARMACEUTICALS~02189P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0131494	11/29/1999	ME	42.0	42		F	11/07/1999	noticed redness & sl swelling around shot area (rt arm) p/vax;next day had rash on rt arm extending entire arm;resembled a heat rash;4th day rash on both arms;6th day noticed rash also on both legs extending entire legs x 4 days;									Y	10/02/1999	10/03/1999	1	NONe	MIL	MIL		NONE	NONE	NA~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Rash	FLU3~PFIZER\WYETH~4998234~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131495	11/29/1999	MO	62.0	62		M	10/27/1999	p/vax pt exp some redness which cont to increase in size;next noc pt began to have fever 102 & cont through next day;h/a & redness cont to increase;									U	10/25/1999	10/25/1999	0	NONE	UNK	UNK		NONE-wife was ill		~ ()~~~In patient	MO99050	1						1	Headache; Injection site hypersensitivity; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0042J~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0131497	11/29/1999	MO	62.0	62		M	11/05/1999	rt arm swollen & tender w/some bruising;dec fingers bend finger but swollen;warm to touch;appeared 3 days post vax;sent to MD; blood clot;									Y	10/26/1999	10/30/1999	4		PUB	PUB				~ ()~~~In patient	MO99052	1						1	Hypertonia; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0163AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0042J~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0131498	11/29/1999	MO	85.0	85		F	10/26/1999	rt upper red, inc warmth & edematous from deltoid area to elbow;									Y	10/25/1999	10/25/1999	0		PUB	PUB				~ ()~~~In patient	MO99049	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0163AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0042J~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0131499	11/29/1999	MO	57.0	57		F	11/02/1999	p/vax pt started having pain & stiffness in wrist & fingers;10/27/99 over the next 2 days knees & ankles were painful & stiff-weakness made it  hard to go up stairs;better today;									Y	10/25/1999	10/27/1999	2	NONE	PUB	PUB		NONE	NONE	~ ()~~~In patient	MO99053	1						1	Arthralgia; Asthenia; Hypertonia; Pain	FLU3~PFIZER\WYETH~4998253~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131500	11/29/1999	MN	58.0	58		F	11/10/1999	chills 12noon 11/05;fever 101 11/05 evening;fever 101.6 11/06;abd cramping, diarrhea 10/06;no fever p/11/06;11/10 still sl diarrhea;									Y	11/04/1999	11/05/1999	1	NONE	PVT	PVT	NONE	NONE	adverse rxn to haprosyn-psuedo effudrine;allergic to cats;	~ ()~~~In patient		1						1	Abdominal pain; Chills; Diarrhoea; Pyrexia	FLU3~PFIZER\WYETH~4998263~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131501	11/29/1999	MN	36.0	36		F	11/10/1999	itching-painful-swelling @ site & in lymph x 1 1/2wk;tx ice, DPH;									Y	10/27/1999	10/30/1999	3	NOEn	PVT	PVT	Prilosic & biaxin in 8/99 x 14 days	NONE	iodine & PCn;bacteria in stomach;hx of +mantoux	pt exp itching, painful, swelling @ site & in lymph w/flu vax dose 1;~ ()~~~In patient		1						1	Injection site oedema; Injection site pain; Lymphadenopathy; Pruritus	FLU3~PFIZER\WYETH~4998263~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131502	11/29/1999	MN	21.0	21		F	11/10/1999	SOB, chills, fever, h/a, body ache;									Y	10/27/1999	10/28/1999	1	unk	PVT	PVT	Birth Control;Depokote;Prozac;	run down from stress of new job & death of brother	codeine, vancomycin, reglan, macrobid;	~ ()~~~In patient		1						1	Dyspnoea; Headache; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4998263~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131503	11/29/1999	MN	50.0	50		F	11/10/1999	chills-achy, neuralgia x 6hr w/confirmed malaise 24hr later;tx bedrest;									Y	10/27/1999	10/27/1999	0	NONe	PVT	PVT	Atenenol;Kador;Pimphau;axid;	NONE	talwin, morphine, beta dose, phisohex, codeine;hx of + mantou;			1						1	Chills; Malaise; Myalgia; Neuralgia	FLU3~PFIZER\WYETH~4998263~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131522	11/29/1999	MA	35.0	35		F	11/10/1999	10/8/99 inflammation/swelling noted @ inj site;discomfort w/ROM;heat pack applied, analgesic;10/9/99 localized inflammation increased;>tenderness inj site firm on palpation;ice wrap applied;									Y	11/08/1999	11/09/1999	1		PUB	PVT	Tapazole	NA	Hyperthyroidism	pt sibling devel localized rxn 2 age 31 w/flu vax;~ ()~~~In Sibling	MA9921	1						1	Injection site inflammation; Injection site mass; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4998283~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131523	11/29/1999	MA	69.0	69		M	11/09/1999	pain & swelling 6hr p/vax;no fever;area around inj site red & hot to touch;pt felt lightheaded, disoriented;MD dx cellulitis/allergic rxn;tx w/cefuroxime;better p/ATB;									Y	11/04/1999	11/04/1999	0	NONE	PUB	PVT		NONE	NONE	NONE~ ()~~~In patient	MA9922	1						1	Cellulitis; Confusional state; Dizziness; Injection site hypersensitivity; Oedema; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0107AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131525	11/29/1999	OK	30.0	29		F	10/22/1999	pain, redness & swelling @ inj site;low grade fever;tx DPH;									Y	10/20/1999	10/21/1999	1	NA	PUB	UNK	Premarin;Methyltestosteruni	NONE	NONE	NONE~ ()~~~In patient	OK9949	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E248096A~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0131527	11/29/1999	OK	45.0	45		F	11/03/1999	p/vax pt noticed itching @ inj site during 8Am shower;saw raised rash;Lt deltoid site had a bruise where pneumo vax given then a welt looking area;rash extending horizontally approx 2 1/2 to irregular depths of 1-1 1/2;warm to touch;									Y	11/01/1999	11/02/1999	1	NA	PUB	PUB	Fiorinal;Actilyn;entex;	NONE	sulfa;	NONE~ ()~~~In patient	OK9951	1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02089P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~0870H~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0131545	11/29/1999	MO	79.0	79		M	11/17/1999	p/vax redness & rash around inj site on rt arm;did not take temp;rash across lower portion of back;dx allergic response to diphtheria;rx Elocon cream & claritin x 4 days;									U	11/04/1999	11/08/1999	4		PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MO99055	1						1	Injection site hypersensitivity; Rash	FLU3~CONNAUGHT LABORATORIES~U0163AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~0997390~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0131551	11/29/1999	AR	44.0	44		F	11/01/1999	red & raised whelps itching;									Y	10/29/1999	10/30/1999	1		OTH	UNK		NONE	had similar rxn to aleve 2-3wk ago;	~ ()~~~In patient	AR9949	1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131553	11/29/1999	GA	51.0	51		F		pt states arm sore by evening of shot;pt arm (pneumonia) but by next day felt warm to touch (24hr later) had temp but not sure how much masked by ASA;rt arm area swollen;extremely difficult to move arm;									Y	11/08/1999	11/08/1999	0		PUB	OTH				~ ()~~~In patient		1						1	Hypokinesia; Injection site oedema; Pain; Pyrexia; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02289~UNK~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1693H~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0131555	11/29/1999	LA	31.0	31		F	11/15/1999	hives on both arms & shoulder blades;worse on lt arm, taking DPh;pt spoke to PMD on phone;									Y	11/08/1999	11/09/1999	1	NA	PUB	PUB	NA	NA	asthma	NA~ ()~~~In patient	LA991104	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~40167AAA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0871H~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0131556	11/29/1999	LA	60.0	60		F	11/08/1999	swelling on administration site, knot, ot to touch 3 in diameter-swelling of face especially under eyes;									Y	11/05/1999	11/05/1999	0	NA	UNK	PUB		NONE	NONE	~ ()~~~In patient	LA991102	1						1	Face oedema; Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~U1067AA~5~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~LEDERLE LABORATORIES~462809~1~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0131558	11/29/1999	IA	73.0	73		M	11/05/1999	arm lt began aching 1-2 days p/vax;prolonged lt shoulder joint aching;lt breast area became sore approx 1wk later;all sx still present;									N	10/06/1999	10/07/1999	1		PUB	PVT	Nitor patch;Xanax, ASA, Albuterol Inhaler & nebulizer, Prilosec BID	NONE	Emphysema;	~ ()~~~In patient		1						1	Arthralgia; Pain	FLU3~CONNAUGHT LABORATORIES~U0066CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131559	11/29/1999	IA	42.0	42		F	11/08/1999	achy feeling x7-10 days;inj site hot, red, tender, size tennis ball x approx 7 days;									Y	10/22/1999	10/23/1999	1		UNK	UNK	prozac	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Myalgia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0066CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131560	11/29/1999	IA	64.0	64		F	11/08/1999	exp joint aches/muscle discomfort generalized & soreness @ inj site x 2-3 days;lump @ inj site size large egg;									Y	10/22/1999	10/23/1999	1		PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Arthralgia; Injection site mass; Injection site pain; Myalgia	FLU3~CONNAUGHT LABORATORIES~U0066CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131561	11/29/1999	MA	42.0	42		F	11/17/1999	24hr p/vax flet heartburn, tightness which cont 48hr;no temp;no other sx;went to walk in but they were closed so left;better 48hr later;									Y	11/03/1999	11/05/1999	2		PUB	UNK		NONE	NONE	~ ()~~~In patient		1						1	Chest pain; Dyspepsia	FLU3~CONNAUGHT LABORATORIES~U0107AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131566	11/30/1999	OR	1.1	1	.1	F	11/01/1999	red & purple bumps over entire body;				Y	Y	1			Y	10/27/1999	10/29/1999	2	blood drawn	PUB	UNK	pt recv DTP/IPV/HIB/MMR 9/22/99;	NONE		~ ()~~~In patient	OR9931	1						1	Rash maculo-papular	FLU3~PARKDALE PHARMACEUTICALS~4099G010~1~~LL~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0131567	11/30/1999	IA	69.0	69		F	11/24/1999	Pt experienced acute & sudden abdominal pain along w/ diaphoresis & shortness of breath.Went to ER & dxed w/ acute pancreatitis & hypokalemia; subsequently hospitalized.				Y	Y				Y	10/22/1999	10/31/1999	9	lipase elevation to 86,673; amylase 2495 on admit;	PVT	PVT	Premarin;Synthroid	NONE	allergy to zithromax & Relafen;Hypothyroidism	NA~ ()~~~In patient		1						1	Abdominal pain; Blood amylase increased; Dyspnoea; Hyperhidrosis; Hypokalaemia; Laboratory test abnormal; Pancreatitis	FLU3~PFIZER\WYETH~4978168~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0131570	11/30/1999	WV	45.0			F	11/30/1999	3 swelling around inj site w/bruise, itchy p/5th day;				Y					Y	11/03/1999	11/05/1999	2		PVT	PVT	flonase, allegra	NONE	asthma, allerg hickory, oak, maple, cat, candles	~ ()~~~In patient		1						1	Ecchymosis; Injection site mass; Injection site oedema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~2~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~98498807~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0131574	11/30/1999	UT	26.0	26		F		p/vax pt dx post vaccinlal brachial plexitis (per neurologist) on opposite arm following routine flu immun;sx numbness, tingling & weakness of arm, shoulder, hand;				Y						10/26/1999				UNK	UNK				~ ()~~~In patient		1						1	Myasthenic syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~U0159AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0131578	11/30/1999	CA	64.0	64		M		p/vax pt devel tingling from hips down w/nl neuro exam;MRI L5 spine negative;NLV c/w GBS;pt last seen 11/15/99 w/resolution of tingling in leg but w/c/o tingling in finger tips;										10/19/1999	10/23/1999	4	nerve conduction study 11/1/99;MRI L5 spine negative;NLV c/w GBS;	UNK	UNK			h/o prostate CA	~ ()~~~In patient		1						1	Paraesthesia	FLU3~PFIZER\WYETH~4998242~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131581	11/30/1999	UT	50.0	50		F	10/15/1999	p/vax s/s runny nose/congestion 1:30PM;nauset @ 3:00;fatigue 7 weakness 5:00;body aches 6:45;diarrhea, fever overall;ill feeling all noc next day;									Y	10/14/1999	10/14/1999	0	NONe	PUB	PUB	premarin;advil	NONE	foot surgery-July 9still uses advil);	pt devel sore arm;~ ()~~~In patient	UT990638	1						1	Asthenia; Diarrhoea; Myalgia; Nausea; Pyrexia; Rhinitis	FLU3~PARKDALE PHARMACEUTICALS~02979P~7+~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~CONNAUGHT LABORATORIES~73608A~7+~~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0131584	11/30/1999	CO	33.0			F	11/08/1999	p/vax pt notice excessive swelling when leaving the clinic;pt visited MD on 10/22/99 explaining rxn as swelling p/inj & arm was black & blue @ inj;claimed was allergic to thimersol an preservative contain w/in vax;									Y		10/14/1999			PUB	UNK				~ ()~~~In patient		1						1	Ecchymosis; Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~U0130AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131588	11/30/1999	VA	50.0	50		F	11/22/1999	5PM-1AM chills, low temp, labored breathing;no tx;									Y	11/01/1999	11/02/1999	1	NONE	OTH	OTH	Hytrin;Timopic;cozzar	NONE	diabetes, autoimmune liver disorder;	~ ()~~~In patient		1						1	Chills; Dyspnoea; Hypothermia	FLU3~PFIZER\WYETH~U0131AA~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131589	11/30/1999	NY	52.0	52		M	11/01/1999	soreness, swelling under lt armpit;no exudate;									Y	10/29/1999	10/31/1999	2	NONE	OTH	PVT		NONE	NONE	NONE~ ()~~~In patient		1						1	Lymphadenopathy	FLU3~PFIZER\WYETH~4998281~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131601	12/01/1999	SC				F	11/25/1999	p/vax pt awoke w/pain rt leg;tried to stand both legs weak & could not move w/o assistance;1hr later to ER c/o numbness in legs & aching in mid/lower back;PE revealed dec sensation w/paralysis @ T7;dx post vaccinal transverse myelitis; 60 day follow-up received on 10/2/00 provided no additional data.					Y			Y	N	11/14/1996	11/15/1996	1	PE-revealed decreased sensation w/paralysis at about T7;	OTH	OTH	NONE				MPU199900536	1						1	Back pain; Hypotonia; Myelitis; Pain; Paraesthesia; Paralysis	FLU3~MEDEVA PHARMA, LTD.~E30966B~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0131606	12/01/1999	CA	35.0			M	11/29/1999	increasing gen weakness x 2 days w/numbness in all toes & fingers & diff walking;dx GBS;tx w/plasma pheresis & disch to nursing facility for rehab;60 day follow-up received on 10/04/00 provided no additional data.			Y	Y	Y	11			N	10/28/1999	11/07/1999	10	CSF protein 55, glucose 126, no monocytes, no WBC;	UNK	UNK	unk	unk	unk			1						1	Asthenia; CSF test abnormal; Guillain-Barre syndrome; Hypokinesia; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0131607	12/01/1999	IL	51.0	51		M	12/01/1999	progressive ascending weakness w/paralysis of both lower extremities;extreme leg pain, burning feet, upper body weakness w/mild resp difficulties /in 6hr post vax sx began;dx GBS;polyneuropathy;60 day follow-up no additional data.Annual follow-up states pt is unable to return to work in any capacity. The pt suffers from many poly and mononeuropathies that interfere with his activities of daily living. He has a gait disturbance and is prone to falls.			Y	Y	Y	10			N	10/20/1999	10/20/1999	0	MRI-neg;Giril Nerve Biopsy-demey of nerve w/some mey;	OTH	PUB	Toprol;ASA;Zocor;Zestril	NONE	HTN, elevated cholesterol;rapid heart rate;			1						1	Guillain-Barre syndrome; Laboratory test abnormal; Myasthenic syndrome; Neuropathy; Pain; Paralysis; Respiratory disorder	FLU3~CONNAUGHT LABORATORIES~U0066EA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0131612	12/01/1999	MI	58.0	58		F	11/12/1999	deltoid area became red & swollen w/discomfort & a white pimple @ inj site;				Y					Y	11/09/1999	11/10/1999	1		PUB	PUB	Prevacid;synthroid;Paxil	epigastric 7 RUQ pain (abd)	PCn;smokes, HTn, hypothyroidism	NA~ ()~~~In patient	MI99127	1						1	Injection site hypersensitivity; Injection site oedema	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~466445~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0131617	12/01/1999	NY	69.0	69		F	11/20/1999	increased congestion;									Y	10/28/1999	10/30/1999	2	NONE	PUB	UNK	unk	NONE	NONE	~ ()~~~In patient		1						1	Rhinitis	FLU3~CONNAUGHT LABORATORIES~U0134AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131618	12/01/1999	OH	72.0	72		F	11/29/1999	approx 1hr p/vax dizzy whil walking in store, held on to dress rack for support, no fall, dizziness resolved p/15min;no SOB, no further episodes reported as of 11/17/99;									Y	10/20/1999	10/20/1999	0	NONE	PUB	PUB	unk	NONE	NONE	~ ()~~~In patient		1						1	Dizziness	FLU3~CONNAUGHT LABORATORIES~U0144AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131623	12/02/1999	MI	78.0	77		M	11/03/1999	hypotension 71/48;T101;chills;body pain;lt arm warm & swollen 4hr p/vax;to ER-ICU adm 10/13;10/16 disch;10/28 readmit w/hypotens, n/v diarrhea;MD assessment local & anaphylactic rxn;pt had I&D of lt arm;area is healing;			Y	Y	Y				Y	10/12/1999	10/12/1999	0	elevated WBC, RBC dec;H&H dec;RDW inc, lymph dec;bands inc;monos inc;Abs lymph dec;Absolute bands H;absolute grans inc;BUN inc;glucose inc;	UNK	UNK	Ventolin Inhaler;Myacalin Nasal spray;Glucotrol;Celebrex;Pepcid;Pred;Plaquinal;Methotrexate;Vitamins;		pollen allergy, asthma, arthritis, varicose veins, atrial fib, DM, hx abd aortic aneurysm repair;ventral hernia repair;bil knee replacement;			1						1	Anaemia; Anaphylactoid reaction; Blood urea increased; Chills; Condition aggravated; Diarrhoea; Hyperglycaemia; Hypotension; Injection site reaction; Laboratory test abnormal; Leukocytosis; Leukopenia; Nausea; Oedema peripheral; Pain; Pyrexia; Vasodilatation; Vomiting	FLU3~PARKDALE PHARMACEUTICALS~03279P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~458743~3~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0131626	12/02/1999	WI	71.0	71		M	11/15/1999	p/vax states could feel it when recv vax then pain devel about 5 days p/vax;now whenever uses arm knows it's there; actually hurts when raises lt arm or does something unusual w/lt arm;vax site has no swelling or redness								Y	Y	10/25/1999	10/30/1999	5	NONE	PUB	PUB	NONE	NONE	NO MD		WI99043	1						1	Injection site pain; Paraesthesia	FLU3~PARKDALE PHARMACEUTICALS~00499P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Disabling	Influenza
0131632	12/02/1999		7.0	7		F	10/29/1999	h/a, n/v;					Y	1			U	10/28/1999	10/28/1999	0		MIL	MIL			sulfa			1						1	Headache; Vomiting	FLU3~PFIZER\WYETH~4998234~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEPA~SMITHKLINE BEECHAM~VHA548A4~1~IM~RA~HEP A (HAVRIX)~1|TYP~PFIZER\WYETH~4998088~1~IM~LA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0131635	12/02/1999	NC	63.0	63		M	11/01/1999	tongue & lips swelled;ears swelled-eyes swelled, lower jaws swelled;broke out all over in huge hives;still feeling very very very weak & dizzy;60 day follow-up / no additional data.			Y	Y					Y	10/21/1999	10/21/1999	0	NA	PUB	PVT	NONE	NONE	NONE			1						1	Asthenia; Dizziness; Face oedema; Tongue oedema; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0131639	12/02/1999	AR				U	11/11/1999	p/vax T98.8, c/o generalized pain;12:00 T101.6-two APAP PO given;11/8/99 12:24 T99.4;11/8/99 330PM c/o severe h/a & body ache, T99.3;c/o h/a worse & body ache;flushed, weakness, resp rapid, shallow, c/o lungs hurt;hosp w/pneumonia & UTI					Y					11/04/1999	11/07/1999	3		OTH	PUB	relafen, nifednipine,MVI, antivert, KCL, megace, ativan			~ ()~~~In patient		1						1	Asthenia; Drug ineffective; Headache; Hyperventilation; Hypoventilation; Myalgia; Pain; Pneumonia; Pyrexia; Urinary tract infection; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~466444~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0131641	12/02/1999	WI	61.0	61		M	11/16/1999	myocardial infarction w/in 24hr of both pneumovax & flu inj;			Y		Y				Y	10/20/1999	10/21/1999	1		PVT	UNK	Atenolol, Zocor, ASA	NONE	CAD-Cornary Artery Disease;	NONE~ ()~~~In patient		1						1	Condition aggravated; Myocardial infarction	FLU3~PFIZER\WYETH~4998283~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~UNKNOWN MANUFACTURER~466443~1~IM~RA~PNEUMO (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0131642	12/02/1999	MN	3.0	3		F	11/15/1999	brainstem & cerebellar edema leading to brain death adm 11/12/99 w/nl LP, MRI;f/u MRI 11/14/ brainstem, cerebellar edema prior hx of CNS problems p/last year's vax also;acute demyelinating encephalomyelitis 10/98 w/bilat temporal lobe; Autopsy stated final diagnosis of seizure and fever,	Y	11/15/1999							N	10/26/1999	11/12/1999	17	nasopharyngeal culture 11/14/99: parainfluenzavirus type I	PVT	PVT	APAP, carbamazepine		30wk prematurity, triplet, mild BPD-resolved; hx of seizures, hx of encephalitis, bronchitis			1						1	Brain oedema; Convulsion; Encephalitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U1032AA~5~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0131645	12/02/1999	ID	1.2	1	.2	M	11/11/1999	tonic-clonic seizure;				Y					Y	11/10/1999	11/11/1999	1		PVT	PVT	aldactone, piuril		Extreme Prematurity, Bronchopulmonary Dysplasia	~ ()~~~In patient		1						1	Convulsion	FLU3~CONNAUGHT LABORATORIES~U0149EA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0131646	12/02/1999	IL	56.0			F	11/24/1999	severe, chronic autoimmune problems throughout life;tx w/steroids, ATB & surgery;ASA now;60 day follow-up states the pt still has severe pain and weakness resemblin flu-like symptoms.			Y	Y	Y			Y	N				although extensive, invasive & debilitating tests were performed, unable to get the data;	OTH	PUB		?				1						1	Asthenia; Immune system disorder; Pain	DTP~UNKNOWN MANUFACTURER~~UNK~~~DTP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|OPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, ORAL (NO BRAND NAME)~1|SMALL~UNKNOWN MANUFACTURER~~UNK~~~SMALLPOX (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0131651	12/02/1999	VA	32.0	32		F	10/06/1999	burning pain 20sec p/vax; p/1hr hard, red, swollen & hot area fromed larger than 2nd shot;reddened area increased in size w/ each successive shot;reddened area max size p/3 days 4 x 4;itching cont;									Y	10/06/1999	10/06/1999	0	NA	MIL	MIL		URi	PCn-sensitivity to lidocaine	pt exprash, knot, itching, redness, swollen, hot w/dose 1&2 anthrax;~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Pruritus; Vasodilatation	ANTH~MICHIGAN DEPT PUB HLTH~FAV041~3~~RA~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0131662	12/02/1999	CA	22.0	22		M	11/12/1999	p/vax pt collapsed immed;no one else in co recv flu vax x/this pt;									Y	10/18/1999	10/18/1999	0		MIL	MIL	NONE	NONE	bee stings	NONE~ ()~~~In patient		1						1	Syncope	ANTH~MICHIGAN DEPT PUB HLTH~~3~~~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0131663	12/02/1999	WA	29.0	29		M	11/04/1999	p/vax pt noticed swelling & redness which has advanced down arm;on exam arm is red, swollen from injs ite down to beyond elbow;no pain or itching noted;no other sx;									Y	11/01/1999	11/03/1999	2	NONE	MIL	MIL		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	ANTH~MICHIGAN DEPT PUB HLTH~FAV037~2~IM~RA~ANTHRAX (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~U01688AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131685	12/02/1999	OK	45.0	45		F	11/01/1999	constantly tired, stiff neck, arms feel as though they will dissconnect @ the shoulder, nausea & fever, sharp pain, numbness;									N	10/16/1999	10/16/1999	0		MIL	MIL	IPPD by NEH lot# 249711 given 10/16/99	NONE	NONE	NONE~ ()~~~In patient		1						1	Arthropathy; Asthenia; Nausea; Nuchal rigidity; Pain; Paraesthesia; Pyrexia	ANTH~MICHIGAN DEPT PUB HLTH~FAV024~UNK~~~ANTHRAX (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~C1004998234~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131702	12/02/1999	ND	34.0	34		M	11/09/1999	p/vax pt woke w/chills (bad);took APAP which helped but presented to clinic c/o myalgia, malaise & feeling chills were returning;local induration rt deltoid;ecchymosis w/induration lt deltoid;tx APAP PRN;recovered;									Y	11/08/1999	11/09/1999	1	NONE	MIL	MIL	NONE	NONE	h/o undifferential spondyloarthropathy 7/96;seronegative arthritis 2/96;	~ ()~~~In patient		1						1	Chills; Ecchymosis; Injection site hypersensitivity; Injection site mass; Malaise; Myalgia	ANTH~MICHIGAN DEPT PUB HLTH~FAV031~3~SC~LA~ANTHRAX (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~U0169AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131707	12/02/1999	CA	34.0	34		M	11/23/1999	p/vax pt devel run dow, overly tired, general achiness;11/23 woke up to pain @ area of  anthrax inj w/redness, firmness & swelling & cont general feeling poorly;										11/21/1999	11/22/1999	1	NA	MIL	MIL	NONE	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Malaise; Myalgia	ANTH~MICHIGAN DEPT PUB HLTH~FAV024~3~~LA~ANTHRAX (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~U0135AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131708	12/02/1999	UT	47.0	47		M	11/18/1999	devel 100mm size nodule @ site of inj w/o extnesion bleow elbow;									Y	11/06/1999	11/06/1999	0	NONe	MIL	MIL		NONE	NONE	~ ()~~~In patient		1						1	Injection site mass	ANTH~MICHIGAN DEPT PUB HLTH~FAV024~1~SC~RA~ANTHRAX (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4998234~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131709	12/02/1999	SC	28.0	27		M	11/17/1999	itchy rash on arms, legs & inbetween fingers;rash started around 11/12/99 & first appeared on fingers;pt has exp same rash each time anthrax shot was given before;										11/04/1999	11/12/1999	8		MIL	MIL	NONE	NONE	NONE	~ ()~~~In patient		1						1	Pruritus; Rash	ANTH~MICHIGAN DEPT PUB HLTH~FAV024~5~SC~~ANTHRAX (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~U0168AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132044	12/03/1999	MA	64.0	64		M	11/19/1999	pt. woke w/hives on lower extrem feet and hands, swollen mouth. Extreme facial swelling. Admitted to hosp for heart arrythmia. RX steroids, benedryl, digitalis, cardizem. Continues w/hives;60 day follow-up states the pt has recovered.					Y	1			Y	11/08/1999	11/10/1999	2		PUB	PUB	none	none	10 years ago hives for no apparent reason		MA9926	1						1	Arrhythmia; Condition aggravated; Face oedema; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0107AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0132045	12/03/1999	NE	58.0	58		M	11/29/1999	p/vax pt devel SOB, bronchitis approx 5wk p/vax;rapid antigen test for influenza A positive when adm to hosp;significantother devel some s/s but wa snot hosp;					Y	3			Y	10/06/1999	11/12/1999	37		PVT	OTH	Coumadin;Propanalol;Cozar;Lasix;Lipitor;Baycid baby ASA;	NONE	HTN, CAD, hyperlipidemia;	~ ()~~~In patient		1						1	Asthma; Bronchitis; Coronary artery disease; Drug ineffective; Dyspnoea; Infection; Influenza; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0064AA~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0132101	12/06/1999	NY	75.0	75		M	11/29/1999	pt devel siolated right 12th nerve pasly 7 days p/vax;60 day follow-up dated 9/22/00 provided no additional data. Annual follow-up dated 1/12/01 states the pt's symptoms have resolved.					Y	2				10/01/1999	10/08/1999	7	carotid duplex negative;CT Scan head-small vessel changes of aging	PVT	PUB	Coumadin;proscar;Verelan;Lanoxin;Lasix;Hytrin, MOM, glucophage;NTG;Imdur;	NONE	CAD, A Fib, DM; intolerant of Zestoretic			1						1	Neuropathy; Paralysis	FLU3~PFIZER\WYETH~4998225~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0132103	12/06/1999	SD	62.0	62		F	11/17/1999	c/o stomachache;projectile vomit;dizzy & diarrhea;started to sweat  & shake & could not see out of lt eye;face swollen & eyes swollen shut, hands & feet swollen;tongue swelled & unable to talk;				Y	Y	1			Y	11/09/1999	11/09/1999	0	NONE	OTH	OTH	Lanoxin, lasix, Accupril, theo-dur, Accolate, Optimine, Prempro, synthroid, motrin, ASA;	NONE	asthma, enlarged heart, shellfish, soybean, chocolate, legumen, mild to citrus & cheese, molds, dust, trees, pollen, dogs, cats, horses, horse serum, demerol;	NONE~ ()~~~In patient		1						1	Abdominal pain; Blindness; Diarrhoea; Dizziness; Face oedema; Hyperhidrosis; Oedema peripheral; Speech disorder; Tongue oedema; Tremor; Vomiting	FLU3~PARKDALE PHARMACEUTICALS~02979P~4~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0132106	12/06/1999	FL	31.0	31		M	12/02/1999	heart felt like it was beating out of chest-150 beats per min;170/90, 117/43 x 11-12hr;activity creates rapid heart beat;			Y	Y					N	11/30/1999	11/30/1999	0	EKG-abn;Bloodwork;low magnesium levels;WBC count-elevated;x-ray	PVT	PUB	Albuterol sulfate;Mag ox;Augmentin;Pred	sore throat, pneumonia, temp,cough	codeine, rheumatic fever, enlarged heart, joint pain;			1						1	Electrocardiogram abnormal; Hypertension; Hypotension; Laboratory test abnormal; Leukocytosis; Palpitations; Tachycardia	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0132107	12/06/1999	MO	51.0	50		M	11/29/1999	approx 4hr p/vax vision narrowed & loss of vision lt half of both eyes;dx from ER w/subsequent test w/o stroke or MS poss;tx w/ASA & pred;vision problems started 11/3/99, partial vision recovered;60 day follow-up / no additional data.				Y	Y			Y	N	11/03/1999	11/03/1999	0	MRI/MRA, reflex tests, VER test, numerous blood tests;	OTH	PVT	NONE	NONE	NONE			1						1	Visual disturbance; Visual field defect; Blindness; Cerebrovascular accident; Multiple sclerosis	FLU3~CONNAUGHT LABORATORIES~U0155AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0155AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation,Disabling	Influenza
0132107	12/07/1999	MD	51.0	50		M	11/29/1999	approx 4hr p/vax vision narrowed & loss of vision lt half of both eyes;dx from emergency room visit w/subsequent tests 9stroke or MS possibly);tx 2 ASA & pred;vision problems started 11/3/99, partial vision recovered 11/20/99;				Y	Y	1		Y	N	11/03/1999	11/03/1999	0	MRI/MRA, reflex tests, VER test, numerous blood tests;	UNK	UNK	NONE	NONE	NONE	NONE~ ()~~0.00~In Patient		1						2	Visual disturbance; Visual field defect; Blindness; Cerebrovascular accident; Multiple sclerosis	FLU3~CONNAUGHT LABORATORIES~U0155AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0155AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation,Disabling	Influenza
0132208	12/07/1999	DC	58.0	58		M	11/30/1999	p/vax pt devel encephalopathy & expressive aphasia;pt hosp;while hosp pt exp a paranoid delusional episode;MD indicated that pthas no psychiatri hx;LP revealed nl cerebrospinal fluid, MRI nl;EEG sl abn w/some slowing c/w encephalopathy;				Y	Y				U	11/04/1999	11/08/1999	4	LP-nl;Nuclear magnetic resonance imaging-nl;Electroencephalogram-sl abn w/some slowing which is c/w encephalopathy;Ultrasound doppler-negative;	OTH	OTH	unk	NONE	unk		6810129NOV199	1						1	Aphasia; Delusion; Electroencephalogram abnormal; Encephalopathy; Paranoia	FLU3~PFIZER\WYETH~4998274~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0132209	12/07/1999	TX	12.0	12		M	11/29/1999	p/vax pt taken to ER & devel throat closing, hives, facial edema;tx w/epi, oral prelone & nebulizer treatment;pt recovered & was sent home from ER;event considered medically important;				Y					Y	11/11/1999	11/12/1999	1	unk	PVT	PVT	unk	unk	unk		6290322NOV199	1						1	Face oedema; Laryngospasm; Urticaria	FLU3~PFIZER\WYETH~4998219~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0132213	12/07/1999	CO	41.0	41		F	11/15/1999	p/vax pt devel mul organ failure-liver, kidney & pulmonary;unk etiology;pt hosp for 21 days;pt recovered from this exp;			Y	Y	Y	21			Y	09/30/1999			10/10/99 ALT= 3807;Lactate Dehydrogenase=23,930;HCT=31.5;CK=1244;Platelets=50;AST=7367;GGT=20;BUN=106;Creatine=6;	PVT	PVT	Elavil, Percoset, Tegratol, Estrogen, Valium;	NONE	allergies-PCn, sulfa;Medical conditions-Bioplar disorder, chronic back pain;	~ ()~~~In patient	U199900952	1						1	Hepatic failure; Lung disorder; Renal failure	FLU3~CONNAUGHT LABORATORIES~U0130AA~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0132216	12/07/1999	VA				F	11/22/1999	p/vax pt devel cellulitis & was adm to hosp;tx w/unspecified ATB & recovered;				Y	Y	2			Y	10/12/1999	10/14/1999	2	unk	PVT	OTH	unk	NONE	unk		33031220CT199	1						1	Cellulitis; Injection site reaction; Cellulitis	FLU3~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~459040~UNK~~LA~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~459040~UNK~~LA~PNEUMO (PNU-IMUNE)~2	USA	Hospitalisation	Influenza
0132223	12/07/1999	MD	58.0	58		F	11/22/1999	p/vax exp a severe episode of asthma;pt hosp for 2 to 3 days;				Y	Y	3			Y	11/04/1999	11/04/1999	0	unk	OTH	OTH	unk	unk	asthma NOS		6012218NOV199	1						1	Asthma; Condition aggravated	FLU3~PFIZER\WYETH~4998245~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0132230	12/07/1999	LA	51.0	50		M	11/16/1999	p/vax pt devel serum sickness & was hosp x 2 days;tx w/cortisone;all sx have now resolved;					Y	2			Y	10/15/1999	11/01/1999	17		UNK	UNK				~ ()~~~In patient	U199900957	1						1	Serum sickness	FLU3~CONNAUGHT LABORATORIES~U0134AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0132242	12/07/1999	WA	50.0	50		M	12/01/1999	p/vax flu like sx on 10/9/99;aches, sweats, high temp fever 101-102, cough, led to pneumonia;ER at hosp-7 days in hosp;02 IV; out of work;60 day follow-up dated 9/26/00 provided no additional data. Annual follow-up dated 9/26/00 provided no additional data.				Y	Y	7			N	10/07/1999	10/09/1999	2		OTH	OTH	NONE	NONE	NONE			1						1	Cough; Hyperhidrosis; Hypoxia; Influenza; Myalgia; Pneumonia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0132243	12/07/1999	NC	72.0	72		M	11/13/1999	resp failure-ventilator support;aspiration;prob septic shock;CHF;60 day follow-up / states the pt died. The pt developed renal and pulmonary disorders and had to be intubated, was dialyzed before he died.	Y	12/09/1999	Y	Y	Y				U	10/05/1999	10/08/1999	3	extemsive	PVT	UNK			polyarythemia/myclofibrodysplastia;cardiomyopathy			1						1	Apnoea; Condition aggravated; Hypoxia; Lung disorder; Respiratory disorder; Right ventricular failure; Sepsis; Shock; Urinary tract disorder	FLU3~CONNAUGHT LABORATORIES~U0063AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0132537	12/15/1999	CA	11.0	11		M	12/08/1999	Pt had fainting within 5 minutes after the shots and fell down. Vomitted x1. VSS nl. Received a dose of epinephrine sc .3cc									Y	12/08/1999	12/08/1999	0	NONE	PVT	PUB		NONE	Asthma, Allergic Rhinitis	~ ()~~~In patient		1						1	Syncope; Vomiting	FLU3~CONNAUGHT LABORATORIES~00130AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1315JQ~UNK~~RA~HEP A (VAQTA)~1	USA		Influenza
0132543	12/15/1999	OK	53.0	53		F	12/09/1999	A pharmacist reported that an employee received an injection of Flu Shield(1999-2000 Formula)on 10/6/99 and subsquently developed resp distress 4.5 hrs after immunization.  Pt. received oxy.,IV Benadryl, IV SoluMedrol, and SC epinephrine.				Y					U	10/06/1999	10/06/1999	0	chest x-ray:negative and Oxy. Sat. was 100%	OTH	OTH	Hydrochlorothiazide              Hyzaar	NONE	Multiple allergies:smoke, grass, cat hair, and yeast		2046111OCT	1						1	Dyspnoea	FLU3~PFIZER\WYETH~4998230~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0132544	12/15/1999		61.0			M	12/09/1999	Guillain-Barre Syndrome;  61-year old male received an injection of Influenza Virus Vaccine. Two weeks later, he developed parasthesias and those types of symptoms.Pt was hospitalized & tx w/ IV immunoglobin w/ no response.					Y				U				LP-elevated CSF protein; electromylogram-acquired demyelinating neuropathy	OTH	OTH					HQ5144110NOV1999	1						1	CSF test abnormal; Guillain-Barre syndrome; Neuropathy; Paraesthesia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0132545	12/15/1999	NY	27.0	27		F	12/09/1999	Septic Arthritis.Pt. received an inj. of expired Flu Sheild on 10/14/99, revaccinated w/ Flu Sheild(99/2000 Form.) on 10/21/99.On 11/19/99 she was unable to walk.  Admitted to hosp. w/ fever of 102.Dx of inflamm/septic arthritis was made					Y				U	10/21/1999	11/19/1999	29	erythrocyte sed.-45mm/hr;wbc-8300/ml.Pt had arthrogram and underwent arthrotomy.  wound cultures were negative	PVT	OTH	NONE	NONE	UNK		6872530NOV	1						1	Arthritis bacterial; Hypokinesia; Leukocytosis; Pyrexia; Red blood cell sedimentation rate increased	FLU3~PFIZER\WYETH~~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0132549	12/15/1999	NE	37.0	37		F	11/29/1999	itching all over, no hives or rash. No wheezing. TX self with OTC Benodryl.									Y	10/29/1999	10/30/1999	1	NONE	PUB	PUB	Zantac 300mg tid	NONE	Allergy to Flouriscein dye	~ ()~~~In patient		1						1	Hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0127AA~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132553	12/15/1999	WI	17.0	17		F	12/07/1999	Aching both arms radiating down back and feet, SOB, freezing cold, T 102.8, and nonproductive cough.				Y					U	12/06/1999	12/07/1999	1	CBC, CXR	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Chills; Cough; Dyspnoea; Myalgia; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~U0202AA~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~SMITHKLINE BEECHAM~3078A2~UNK~IM A~~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0132558	12/15/1999	NE	41.0	41		F	10/29/1999	Arm red, swollen, and sore for a week; stayed red for a long time. O.K. now.									Y	10/13/1999	10/13/1999	0		OTH	OTH		NONE		~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~U0150AA~UNK~A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132561	12/15/1999	AR	20.0	19		M	12/07/1999	Extreme soreness in area where shot was administered.									U	04/26/1968	04/26/1968	0	Diagnosed with Multiple Sclerosis 1999	MIL	MIL						1						1	Injection site pain; Multiple sclerosis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PLAGUE~UNKNOWN MANUFACTURER~~1~~~PLAGUE (NO BRAND NAME)~1	USA		Influenza
0132564	12/15/1999	WY	45.0	45		F	11/18/1999	10/27/99: 3 1/2 cm x 2 1/2 cm reddened raised area.10/28/99: 3 1/2 cm x 3 1/2 cm slightly hard underneath reddened area with itching.11/6/99: 2 cm x 2 cm hard area.				Y					Y	10/26/1999	10/27/1999	1		MIL	MIL	Synthroid	NONE	Hypothyroidism	~ ()~~~In patient		1						1	Hypothyroidism; Injection site hypersensitivity; Injection site mass; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0145FA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0132567	12/15/1999	MT	54.0	54		M	12/01/1999	10/18/99 pt reported day after given flu vax, arm, neck and back starting aching. The next day, he had hallucinations, day dreams, and he was cold. Better on Monday but noted swelling and hard knot at injection site.									Y	10/15/1999	10/16/1999	1		PVT	PVT		NONE	gout	~ ()~~~In patient		1						1	Back pain; Chills; Gout; Hallucination; Injection site mass; Myalgia	FLU3~PFIZER\WYETH~4998211~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0132572	12/15/1999	NC	30.0	30		F		Large 5-7 cm area of localized edema, erythema, induration, and warmth on right lateral deltoid area surrounding site of vaccination 3 days prior.  Also had associated fever of 102 and myalgias.									Y	11/16/1999	11/18/1999	2		PVT	PVT	synthroid					1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Myalgia; Pseudo lymphoma; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~U0152AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0043J~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0132574	12/15/1999	WA	43.0	43		F	10/13/1999	10/11/99:recieved vaccine and noticed two blisters overlying posterior left deltoid on 10/12/99, 1 cm each. 10/13/99:vessicle burst weeping clear fluid.									U	10/11/1999	10/12/1999	1		OTH	PVT				~ ()~~~In patient		1						1	Dermatitis bullous; Injection site reaction	FLU3~CONNAUGHT LABORATORIES~U0108DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132580	12/16/1999	MO				F		Approx. 5 hours post vac., c/o chills, shakey, difficulty breathing, reddened skin, tachycardia, hypertension. Vital signs 98.1, 130, 22, 160/110. Sent to ER and treated with Allegra D, Benadryl, Pepcid. Sent home, off of work 1 day.				Y					Y	11/11/1999	11/11/1999	0	NONE	PVT	PVT	Plendil, Depo Provera, Allegra D, Benadryl, Pepcid		Hypertension	~ ()~~~In patient		1						1	Chills; Dyspnoea; Hypertension; Nervousness; Tachycardia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0104AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0132137	12/17/1999	SC	29.0	29		M	11/23/1999	swelling area approx 4x4, redness, soreness and hot to touch of upper rt arm. Anthrax #2 given 11/29/99.				Y					U	11/21/1999	11/23/1999	2		UNK	UNK	NONE					1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	ANTH~MICHIGAN DEPT PUB HLTH~FAV031~3~SC~RA~ANTHRAX (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~U0135AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0132314	12/17/1999	IA	18.0	18		M	12/07/1999	Idiopathic thrombocytopenia purpura, possibly related to receipt of numerous vaccines.Petechia on feet noted on PE. Responded to steroids w/slight resolution.			Y	Y	Y	4			N	11/08/1999	12/01/1999	23	cbc,platelet ct noted to be 58,000 12/1/99,35,000 12/2/99,15,000 12/3/99,18,000 12/4/99,26,000 12/5/99.	MIL	MIL	NONE	NONE	NONE	~ ()~~~In patient		1						1	Petechiae; Thrombocytopenic purpura	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~IM~~HEP A (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~UNK~SC~~MENINGOCOCCAL (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~SC~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|OPV~UNKNOWN MANUFACTURER~~UNK~PO~MO~POLIO VIRUS, ORAL (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~IM~~TD ADSORBED (NO BRAND NAME)~1|YF~UNKNOWN MANUFACTURER~~UNK~SC~~YELLOW FEVER (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0132404	12/17/1999	ND	10.0	10		F	12/01/1999	@ 24 hrs post flu vax, pt began having seizures increasing over the following 16 hrs to almost status. She also had fever to 101. She already is a seizure pt on medication.					Y	2			Y	11/18/1999	11/19/1999	1	tegretol levels were therapeutic	PVT	PVT	Captopril, Carbitol,  Tegretol	NONE	seizure disorder,difficult to control @ times,s/p cva		ND9923	1						1	Convulsion; Pyrexia	FLU3~PFIZER\WYETH~4998254~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0132431	12/17/1999	OK	64.0	64		F	12/06/1999	2 hrs post vax developed fever, aches, pains, interm. altered mental status, diarrhea. Had brief resp arrest, was unconscious, intubated, & marked hyperthermia.Hospitalized & dxed w/ pneumonia; txed w/ IV Ancef.			Y	Y	Y	13			Y	10/26/1999	10/26/1999	0	Chest x-ray - pleural effusion, pneumonia	PUB	PVT			AORTIC STENOSIS, ALLERGY TO PCN	~ ()~~~In patient		1						1	Apnoea; Coagulopathy; Cough; Diarrhoea; Hypoxia; Malaise; Pleural effusion; Pneumonia; Pulmonary haemorrhage; Pyrexia; Thinking abnormal	FLUX~UNKNOWN MANUFACTURER~03279P~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0132433	12/17/1999	VA	12.0	12		M	12/05/1999	At 21:00 felt hot, had tachycardia and tachypnea. Later/very restless, talking incoherent. Hosp 11/24/99 for acute rad. On nebulizers x3 in ER to stabilize,then every 3 hrs. for 1st 24 hrs. Wheezing, rales.					Y	3			Y	11/23/1999	11/23/1999	0	negutive cxr, cbc	MIL	MIL	methylphenidate, vitamins	cold		~ ()~~~In patient		1						1	Agitation; Asthma; Confusional state; Dizziness; Hyperventilation; Lung disorder; Tachycardia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~UOL688A~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0132442	12/17/1999	ME	21.0	21		M	12/06/1999	Arm swelled up from point of shot down to elbow.Skin was hot where it was swelled,stiff, and achy.									Y	11/30/1999	11/30/1999	0		MIL	MIL				~ ()~~~In patient		1						1	Hypertonia; Injection site oedema; Myalgia	ANTH~MICHIGAN DEPT PUB HLTH~FAV024~3~SC~LA~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0132598	12/17/1999	FL	31.0	31		M	10/15/1999	pt recv anthrax/meningococal/influenza vax 10-14-99. 10-15-99 at 6:00pm exp hives upper/lower extremities. seen at hosp er, treated with Hydroxyzine 1.4 tabs every 6 hrs also Methylpred.				Y					Y	10/14/1999	10/15/1999	1		MIL	MIL	NONE	mild cold symptoms	allergy/chocolate, childhood asthma	~ ()~~~In patient		1						1	Asthma; Urticaria	ANTH~MICHIGAN DEPT PUB HLTH~FAV041~2~SC~~ANTHRAX (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~U0145EA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~CONNAUGHT LABORATORIES~099670~2~SC~~MENINGOCOCCAL (MENOMUNE)~1	USA	Emergency room visit	Influenza
0132599	12/17/1999	CA	43.0	43		F		Tingling on arms,legs,face for 2 days after vax; 5 days later prickling, tingling in feet, numbness in lower legs & feet, slowly subsided. Dx:post-vax paresthesias/neuritis.				Y					U	11/05/1999	11/08/1999	3	Elevated ANA, decreased C3,C4	PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Neuritis; Paraesthesia; Neuritis; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~U0102AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0102AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0132501	12/20/1999	IN	71.0	71		F	12/07/1999	Within 24 hrs of receiving vaccination, pt. had T-103,severe headache.48 hrs later had a grand-mal seizure & respiratory arrest.  Dxed as having herpes encephalitis.(culture negative)			Y	Y	Y	9			N	10/25/1999	10/26/1999	1	spinal fluid c/w viral encephalitis, MRI/CT c/w herpes like encephalitis	OTH	OTH	NONE	NONE	Allergy to aspirin			1						1	Apnoea; Atelectasis; Encephalitis; Grand mal convulsion; Headache; Hypertension; Hypoxia; Pyrexia; Sepsis	FLU3~CONNAUGHT LABORATORIES~U0145SB~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0132620	12/20/1999	WA	12.0	12		F	12/10/1999	1 mon after vax pt had major flare & systemic onset juvenile rheumatoid arthritis w/ pleuritis & pericarditis requiring corticosteroid treatment.				Y	Y	2			Y	10/25/1999	11/22/1999	28	Blood tests, chest xray	PVT	OTH	Solumedrol,Prednisone	NONE	Systemic onset juvenile rheumoatoid arthritis			1						1	Pericarditis; Pleural disorder; Rheumatoid arthritis	FLU3~CONNAUGHT LABORATORIES~46130~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~U0130AA~1~IM~LA~HEP B (RECOMBIVAX HB)~1	USA	Hospitalisation	Influenza
0132624	12/20/1999	NV	43.0	43		M	10/26/1999	Approx 1 hr after vaccine, skin color was gray and diaphoretic.  Feels very sick, vomited.  Talking silly.  Swaying back and forth while standing. Thick tongue. V/S p 80, r 16			Y	Y					Y	10/26/1999	10/26/1999	0	Chem 7: with mgd Ca  8.7 glucose 165	OTH	UNK		NONE	NONE	~ ()~~~In patient	NV99018	1						1	Coordination abnormal; Hyperglycaemia; Hyperhidrosis; Malaise; Skin discolouration; Speech disorder; Vomiting	FLU3~PFIZER\WYETH~4998287~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening	Influenza
0132641	12/20/1999	OH	75.0	75		F	12/02/1999	sore deltoid muscle--advil 2/tidx 2d, site swelling-ice 10 min/hr. No temp-began 10 hrs after shot.									Y	11/30/1999	11/30/1999	0		OTH	PVT	aricept 5mg po	NONE				1						1	Injection site oedema; Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~02679P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~458746~1~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0132643	12/20/1999	MI	49.0	49		F	12/13/1999	Itchy rash developed 24 hrs after vaccinated at site and down arm to wrist-lasted 2 wks.									Y	11/29/1999	11/30/1999	1	NONE	PUB	PVT	methotrexate,naprosyn,azulfione,folic acid	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Rash	FLU3~PARKDALE PHARMACEUTICALS~02289P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0132651	12/20/1999	CO	55.0	55		F	10/26/1999	10/15/99:Pt. received vaccination.10/17:arm was sore and pt. did not feel well.10/19:pt. itching.10/21:rash started on arms and spread.10/24:rash worse.				Y					Y	10/15/1999	10/21/1999	6		PUB	PUB	NONE		Hay fever	~ ()~~~In patient	CO99036	1						1	Malaise; Pain; Rash	FLU3~PFIZER\WYETH~4998268~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0132653	12/20/1999	MD	32.0	32		F	10/22/1999	Nasal congestion;face red blotchy and swollen from nose up and during the course of talking, the redness spread below nose and around mouth.  Pt called the following day and stated that 30 min. after taking benadryl she was back to normal.									Y	10/20/1999	10/20/1999	0		PUB	OTH		NONE	NONE	~ ()~~~In patient		1						1	Oedema; Rash maculo-papular; Rhinitis; Vasodilatation	FLU3~PFIZER\WYETH~4998243~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0132654	12/20/1999	SC	59.0	58		M	11/12/1999	2 days after vaccination pt. reported redness,swelling,& pain in right arm.Pt. stated tx w/ Keflex by MD.				Y					N	11/08/1999	11/10/1999	2		PUB	PUB		NONE	UNK	~ ()~~~In patient	SC99081	1						1	Oedema peripheral; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0145BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1095H~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~U0011AA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0132656	12/20/1999	SC	50.0	50		F	12/09/1999	12/7/99:Pt. rcvd. pneumo & flu shot.Pt. complained of a burning sensation around a reddened area that is approx. 4 1/2 long and 1 1/2 wide.Pt. also complains of pain from her shoulder to her elbow on her right arm.				Y					U	12/07/1999	12/08/1999	1		PUB	OTH	NONE	NONE	Asthma		SC99082	1						1	Injection site hypersensitivity; Injection site pain	FLU3~CONNAUGHT LABORATORIES~U0205AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~462810~2~~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0132661	12/20/1999	OH	30.0	30		M	12/17/1999	Nasal conjestion on 12/14. On 12/15 felt feverish, more congestion from the neck up. On 12/16 fever cont. & tx w/Alka-Seltzer Cold Tabs. Congestion now in chest w/cough & wheezing. No relief of symptoms. Sugar level elevated, less/excercise									N	12/14/1999	12/14/1999	0		PUB	PUB	Insulin	NONE	Asthma, Diabetes	~ ()~~~In patient		1						1	Asthma; Chest pain; Cough; Diabetes mellitus; Hyperglycaemia; Pyrexia; Rhinitis; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0132664	12/20/1999	NY	56.0	56		F	10/25/1999	10/20/99 at 3p pt recv flu and pneumo vax., 2 a 10/4/99:temp 101.1, chills, shakes, aches all over. Temp continues till 10/22/99 along w/ aches. L arm red, warm swollen 4 days after imm.									Y	10/20/1999	10/21/1999	1		PUB	PUB	Cardizem	NONE	Cardiac		NY99039	1						1	Myalgia; Oedema peripheral; Pyrexia; Tremor; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~01889P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0132666	12/20/1999	FL	11.0	11		F	12/20/1999	Seen in MD office 12/14 for severe headache & numbness in hands.12/15, seen again w/ slurred speech, clubbing of hand, numbness of right side,& crying.Admitted to PICU x 4 days, pt. recovered and discharged 12/19. Upper extrem weakness, facial weakness, 12 nerve palsy.					Y	4			Y	12/10/1999	12/14/1999	4	CSF-cultured negative,protein 61, glucose-wnl,brain MRI-widespread demyelinization,CBC-wnl	UNK	UNK	Flovent	NONE				1						1	Agitation; Asthma; Blood glucose normal; CSF culture negative; CSF protein increased; Clubbing; Crying; Demyelination; Dysarthria; Facial paresis; Full blood count normal; Headache; Hypertrophy; Hypoaesthesia; Hypoaesthesia; Hypoglossal nerve disorder; Intensive care; Muscular weakness; Nuclear magnetic resonance imaging brain abnormal; Paraesthesia; Speech disorder	FLU3~CONNAUGHT LABORATORIES~U0063AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0132689	12/20/1999	ID	44.0	44		F	11/19/1999	Had Hives when called back on 11/18/1999.									N	11/12/1999	11/13/1999	1	NONE REPORTED	PUB	PUB	Vancinase and Projestin	NONE	Asthmaic; allergic to antihystamine, Benadryl		ID99032	1						1	Urticaria	FLU3~PARKDALE PHARMACEUTICALS~02289P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1247H~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~0960580~2~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0115906	12/21/1999	MT	89.0	89		F		10/5/98:Pt. was vaccinated w/ Fluvirin & Pnu-Imune, developed nausea,vomiting,syncope,& severe swelling at the site of Pnu-Imune inj. which progressed into celllulitis.Pt. was hospitalized and developed aspiration pneumonia.				Y	Y	2			Y	10/05/1998	10/05/1998	0		PUB	PUB	Zestoretic,Thyoid		Hypertension,asthma,thyroid problems		MPU199900378	1						3	Cellulitis; Hypertension; Injection site oedema; Pneumonia aspiration; Skin discolouration; Syncope; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E20188HD~6~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~3	USA	Hospitalisation	Influenza
0132306	12/21/1999	AR	78.0	78		F	12/03/1999	Recv Pnu-Imune-23 & Fluzone (PMC USA) in 1 syringe 11/4/99.  11/7, 4am devel generalized pain. At 12pm temp was 101.6 F. Pt recv 2 Tylenol. 11/8, 12:24pm temp was 99.4. 3:30pm pt devel severe head & body ache. Darvocet-N given. Pt hosp.					Y				Y	11/04/1999	11/07/1999	3	UNK	OTH	PUB	Antivert,Megaclor	UNK	anemia, CVA, COPD, dementia, hypertension, hypokalemia, osteoarthritis		7160102DEC	1						1	Anaemia; Arthritis; Cerebrovascular accident; Dementia; Headache; Hypertension; Hypokalaemia; Lung disorder; Myalgia; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466444~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0132675	12/21/1999	TN	26.0	26		F	11/19/1999	Pt. given flu shot at approx. 2:55pm-returned about 3pm complaining of tightness & difficulty breathing.									Y	11/16/1999	11/16/1999	0		PUB	PUB	Pulmocort,Reglan,Albuterol,Epinephrine	NONE	Asthma	~ ()~~~In patient	TN99049	1						1	Asthma; Dyspnoea	FLU3~MEDEVA PHARMA, LTD.~E30899LA~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0132678	12/21/1999	CO	4.0	4		M	11/01/1999	Diffuse urticaria 36 hrs after influenza vaccine				Y					Y	10/23/1999	10/24/1999	1	NONE	PVT	PVT	NONE	NONE	GER, poor weight gain,chronic otitis	~ ()~~~In patient	CO99038	1						1	Gastrointestinal disorder; Otitis media; Urticaria; Weight increased	FLU3~PFIZER\WYETH~4998210~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0132685	12/21/1999	CA	34.0	33		F	11/09/1999	Red area left deltoid, site of injection, 3x1.5. Complaining of total body aches, chills, sweats, starting 8 hours after injection.									U	11/07/1999	11/08/1999	1		PVT	PVT	Levothyroxin     Cytomel	NONE	Allergic to PCN	~ ()~~~In patient		1						1	Chills; Hyperhidrosis; Injection site hypersensitivity; Myalgia	FLU3~PFIZER\WYETH~4998422~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0132688	12/21/1999	AL	42.0	42		F	11/18/1999	Pt woke-up 11/6/99 disoriented, dizzy, nauseated, vomiting, blurred vision, difficulty breathing. Went to ER and tx w/iv fluids, antivert. She felt better and was discharged. No overnight stay.				Y					Y	11/04/1999	11/06/1999	2	chest x-ray & CT scan/both negative	PUB	PUB	NONE	NONE	grass allergy	~ ()~~~In patient	AL9924	1						1	Amblyopia; Confusional state; Dizziness; Dyspnoea; Vomiting	FLU3~PFIZER\WYETH~4998232~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0132692	12/21/1999		34.0	34		F	12/07/1999	Large local reaction 20x20cm on left tricep.									Y	12/01/1999	12/02/1999	1	NONE	MIL	MIL	Prilosec/Carafate	NONE	NONE			1						1	Injection site reaction	ANTH~EMERGENT BIOSOLUTIONS~FAV024~2~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~CONNAUGHT LABORATORIES~U0268AA~1~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|JEV~CONNAUGHT LABORATORIES~EJN169A~2~SC~LA~JAPANESE ENCEPHALITIS (J-VAX)~1	USA		Influenza
0132694	12/21/1999	NY	6.0	6		F	12/14/1999	Local induration 3 1/2 x 2 1/2 w/vessicles on left arm. Fever 103.8.									Y	12/13/1999	12/13/1999	0	Wound cultured	PVT	PVT		Sinusitus				1						1	Injection site hypersensitivity; Injection site mass; Pyrexia	FLU3~CONNAUGHT LABORATORIES~V0156AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466445~1~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0132695	12/21/1999	IL	58.0	58		M	12/14/1999	Rt eye twitching to left upper lip twitching. Fatigue, achey.									Y	10/25/1999	10/25/1999	0		PVT	PVT				~ ()~~~In patient		1						1	Asthenia; Muscle twitching; Myalgia	FLU3~CONNAUGHT LABORATORIES~U0126FA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132696	12/21/1999	IL	41.0	41		F	12/14/1999	Broke out in hives.									Y	10/28/1999	10/28/1999	0		PUB	PVT				~ ()~~~In patient		1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~U0126FA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132697	12/21/1999	IL	40.0	40		F	12/14/1999	Became lightheaded.									Y	10/22/1999	10/22/1999	0		PUB	UNK				~ ()~~~In patient		1						1	Dizziness	FLU3~CONNAUGHT LABORATORIES~U0126FA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132698	12/21/1999	IL	77.0	77		F	12/14/1999	Red mark, size of lemon, at injection site.									Y	10/19/1999	10/19/1999	0		PVT	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0126FA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132699	12/21/1999	IL	54.0	54		F	12/17/1999	Lightheaded and nausea.									Y	10/18/1999	10/18/1999	0		PUB	PVT				~ ()~~~In patient		1						1	Dizziness; Nausea	FLU3~CONNAUGHT LABORATORIES~40126FA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132700	12/21/1999	IL	78.0	78		F	12/14/1999	Vomiting, fever				Y					Y	10/15/1999	10/15/1999	0		PVT	PVT		UTI		~ ()~~~In patient		1						1	Pyrexia; Urinary tract infection; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0121FA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0132701	12/21/1999	IL	43.0	43		F	12/14/1999	Nausea, diarrhea									Y	10/14/1999	10/14/1999	0		PUB	OTH		Diabetes	Diabetes	~ ()~~~In patient		1						1	Diabetes mellitus; Diarrhoea; Nausea	FLU3~CONNAUGHT LABORATORIES~U0126FA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132702	12/21/1999	IL	68.0	68		F	12/14/1999	Right shoulder/arm red and swollen. Had pain during the night.									Y	10/14/1999	10/14/1999	0		PVT	PVT				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pain	FLU3~CONNAUGHT LABORATORIES~U0126FA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1693H~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0132703	12/21/1999	IL	57.0	57		F	12/14/1999	Arm swollen at injection site and swelling down to fingers.									Y	10/10/1999	10/10/1999	0		UNK	UNK			Mastectomy			1						1	Injection site oedema; Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~401268A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1693H~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0132704	12/21/1999	IL	69.0	69		F	12/14/1999	Vomiting,diarrhea.									Y	10/09/1999	10/09/1999	0		PUB	PVT				~ ()~~~In patient		1						1	Diarrhoea; Vomiting	FLU3~CONNAUGHT LABORATORIES~401268A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132705	12/21/1999	IL	75.0	75		F	12/14/1999	Diarrhea,generalized achiness									Y	10/09/1999	10/09/1999	0		PUB	PVT				~ ()~~~In patient		1						1	Diarrhoea; Myalgia	FLU3~CONNAUGHT LABORATORIES~401268A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132706	12/21/1999	IL	61.0	61		F	12/14/1999	Left arm/shoulder sore. Feels like dead weight.										10/21/1999	10/21/1999	0		PUB	PVT				~ ()~~~In patient		1						1	Pain	FLU3~CONNAUGHT LABORATORIES~U0126FA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132711	12/21/1999	TN	71.0	71		F	10/28/1999	Moderate to severe local reaction began a few hrs. after receiving immunization & gradually worsened. Had redness, edema and warmth in the next 2 days. Sent to see her PCP. Tx, cold pack, Benadryl. Local rx in rt upper arm, inject.site down									Y	10/26/1999	10/26/1999	0		PUB	PUB					TN99048	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E29179HA~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0132713	12/21/1999	ID	17.0	17		M	11/29/1999	11/12/99:Pt. rcvd. Flu vaccine, went to ER on 11/16 complaining of weakness and numbness in right arm,shoulder, and in both legs.Symptoms persisted in legs approx. 12 hrs.11/29/99:Pt. complained of numbness in right hand.				Y					N	11/12/1999	11/15/1999	3	CBC, bone scan	OTH	PVT	NONE	NONE	lower spinal deformity from birth		ID99035	1						1	Asthenia; Congenital anomaly; Paraesthesia	FLU3~PARKDALE PHARMACEUTICALS~02289P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0132717	12/21/1999	MI	59.0	59		M	12/20/1999										N	12/16/1999	12/17/1999	1		PUB	PUB						1						1	Cerebrovascular accident; Cough; Headache; Hypercholesterolaemia; Hypertension; Myalgia; Pharyngitis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0132721	12/21/1999	CO	47.0	47		F	10/22/1999	Employee received flu vaccine and approx. 30 minutes later presented with swollen tongue, wheezing, & shortness of breath.				Y					Y	10/18/1999	10/18/1999	0	NONE	PUB	PVT	Clonopin,Estrace	NONE	allergies to Tegretol, Codeine, & Enbach 2	~ ()~~~In patient	CO99043	1						1	Asthma; Dyspnoea; Hypersensitivity; Tongue oedema	FLU3~PFIZER\WYETH~4998259~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0132726	12/21/1999	MO	60.0	60		F	12/20/1999	Awoke in 12/1/99 a.m. following vaccine on 11/30/99 with numbness in both legs, burning and tingling of both feet, felt cold, weakness in L/leg, unsteady gait. Saw neurologist, MRI to follow.				Y					N	11/30/1999	12/01/1999	1	Blood work, Physical Exam	PVT	PVT	Estrotipate, Medroxypro			~ ()~~~In patient		1						1	Asthenia; Chills; Gait disturbance; Pain; Paraesthesia	FLU3~PARKDALE PHARMACEUTICALS~03079P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0132728	12/21/1999	UT	71.0	70		M	12/20/1999	Lump under armpit				Y					N	10/08/1999	10/09/1999	1	Chest x-ray, cbc-all within normal limits	PVT	PVT				~ ()~~~In patient		1						1	Skin nodule	FLU3~PFIZER\WYETH~~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0132730	12/22/1999	MN	58.0	58		M	12/16/1999	Within 1 hr of receiving flu shot, pt. began having severe gas that turned into diarrhea;which is still present 1 month after injection.				Y					N	11/11/1999	11/11/1999	0	Stool cultures-Neg.   Flex Sig-Neg	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Diarrhoea; Eructation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0132731	12/22/1999	CA	60.0	60		F	12/14/1999	Pt had flu vax on 11/11/99. On 11/18/99, she had dizziness which became gradually significant w/progression to ataxia, weakness of lwr extremities & ptosis. Pt admitted to hosp dx w/Guillaine-Barre' Syndrome and tx w/plasmaphoresis. 60 day follow-up dated 09/27/00 provided no additional data. Discharge summary states principal dx to be GBS (Miller-Fisher varient), opthalmoplegia with ptosis and the secondary dx to be ataxia, hypertension and diabetes					Y				Y	11/11/1999	11/18/1999	7	Electromyelogram; plasmaphoresis	PVT	PVT	verapamil, colaar, glucophage, gluburide	cough	diabetes mellitis, hypertension			1						1	Asthenia; Coordination abnormal; Cough; Diabetes mellitus; Dizziness; Eyelid ptosis; Guillain-Barre syndrome; Hypertension; Ophthalmoplegia	FLU3~CONNAUGHT LABORATORIES~U0136AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0132733	12/22/1999	AL	6.0	6		M	12/10/1999	Left knee swelling, cellulitis, septic joint. Admitted to hospital 12/3/99-12/4/99. Received IV antibiotics x 24 hrs. then discharged.					Y	1			Y	12/01/1999	12/02/1999	1	Knee x-ray- joint effusion    CBC-nl   Bld cx-nl	PVT	PUB	albuterol-mdi  Intal-mdi	NONE	milk allergy,RAD, eczema	~ ()~~~In patient	AL9925	1						1	Asthma; Cellulitis; Eczema; Hypersensitivity; Infection; Oedema peripheral; Osteoarthritis	FLU3~CONNAUGHT LABORATORIES~4998344~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0132739	12/22/1999	AR	13.0	13		M	11/05/1999	Pt. with whelps, itching, and all over body rash.Seen by local MD and treated with steroids and antihistamine.Rash progressively got worse over the next day, but no fever.				Y					Y	11/02/1999	11/04/1999	2		PUB	PUB	Clindamycin	osteomyelitis	NONE	~ ()~~~In patient	AR9952	1						1	Osteomyelitis; Pruritus; Rash; Urticaria	FLU3~PFIZER\WYETH~4998230~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0132816	12/23/1999		19.0	19		M	10/25/1999	Pt. had swelling, warmth, pain & erythema in rt. arm, at injection site. Tx'd with Motrin 800mg, swelling down to normal after 5 doses. Also, had flu shot at same time.				Y					Y	10/22/1999	10/24/1999	2		UNK	UNK		NONE	NONE			1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	ANTH~EMERGENT BIOSOLUTIONS~FAV044~6~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~PFIZER\WYETH~4998235~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0132216	12/27/1999	VA				F	12/16/1999	MD reported pt received Pnu-Imune 23 and 1999-2000 vax formula influenza virus (mfr unk) on 10/12/99. On 10/14/99, she developed cellulitis, was admitted to hosp,tx w/unspecified antibiotics & recovered.				Y	Y	2			Y	10/12/1999	10/14/1999	2	CBC-nml and 2 sets of blood cultures-neg.	PVT	OTH	Lasix,Premarin tablet	NONE	Lymphoedema/NOS		3303122OCT	1						2	Cellulitis; Injection site reaction; Cellulitis	FLU3~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~459040~UNK~~LA~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~459040~UNK~~LA~PNEUMO (PNU-IMUNE)~2	USA	Hospitalisation	Influenza
0132822	12/27/1999	MA	54.0	54		F	10/25/1999	Feeling light-headed,shaky,arm feels weak,heart racing. Feels like passing out,throat dry. Fellow worker says she appears flushed, perspiring. Resp. problem. EMT arrived & found her unconscious was given epinephrine,but refused admission to				Y					Y	10/22/1999	10/22/1999	0		OTH	PVT	NONE	NONE	allergy to penicillin,erythromycin, ? other antibiotics	~ ()~~~In patient		1						1	Coma; Dizziness; Dry mouth; Hyperhidrosis; Myasthenic syndrome; Nervousness; Tachycardia; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~4099J010~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0132824	12/27/1999	MI	45.0	45		F	12/15/1999	10/12/99:Pt. rcvd vacc.10/22/99:pt complained of a temp.,muscle aches, tiredness,& joint pain.11/7/99:pt. dvlped swelling of hands and face.11/8/99:pt. experienced atrial fib and was admitted into ICU for observation.				Y	Y				Y	10/12/1999	10/22/1999	10		UNK	UNK				~ ()~~~In patient	U1999010440	1						1	Arthralgia; Asthenia; Atrial fibrillation; Face oedema; Myalgia; Oedema peripheral; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0163AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0132832	12/27/1999		57.0	57		M	12/13/1999	Pt developed a Bell's Palsy within 72 hrs of flu vax.									U	10/23/1999	10/26/1999	3		UNK	UNK				~ ()~~~In patient		1						1	Facial palsy	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0132833	12/27/1999	KY	45.0	45		M	12/06/1999	Guillain Barre syndrom 10 days after influenza vaccine.Pt. had distal limb weakness,decreased DTR.Pt had coughing & sore throat prior to developing GBS.					Y			Y		11/03/1999	11/13/1999	10	EMG-neuropathy/LP-protein=75	UNK	UNK	IV Ig.			~ ()~~~In patient		1						1	Guillain-Barre syndrome; Myasthenic syndrome; Neuropathy	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0132835	12/27/1999	NJ	45.0	45		F	12/09/1999	Pt received flu shot and developed MS flare,visual disturbance, & dysarthria.								Y	Y	10/28/1999	11/03/1999	6		UNK	UNK			Multiple Sclerosis	~ ()~~~In patient		1						1	Condition aggravated; Dysarthria; Multiple sclerosis; Visual disturbance	FLU3~CONNAUGHT LABORATORIES~4998226~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0132836	12/27/1999	NJ	29.0	29		F	12/09/1999	Pt. received flu shot and developed MS flare while pregnant.Pt. hemiparetic with residual after IV Solumedrol.60 day follow-up states it is unknown if the pt recovered.								Y	U	10/20/1999	10/27/1999	7		UNK	UNK	Solumedrol, prednisone		pregnant, Multiple Sclerosis			1						1	Condition aggravated; Hemiplegia; Multiple sclerosis	FLUX~UNKNOWN MANUFACTURER~4998226~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0132843	12/27/1999	NE	51.0	51		M	12/04/1999	Received flu shot on 11/3/99 at 10:30 am and by 2:00 pm was experiencing double vision which is still occuring. Per follow-up, the pt is 95% recovered. Pt suffers from slight diplopia.				Y				Y	N	11/03/1999	11/03/1999	0	EKG/ECG, MRI/brain, echo carotid, CT/head, cerv-spine obliques,mra head & neck	PVT	PVT		double vision and flu-like symptoms	NONE			1						1	Diplopia; Influenza	FLU3~CONNAUGHT LABORATORIES~U0186~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0132844	12/27/1999	MD	64.0			F	10/29/1999	Pt. complained of rt upper arm swelling down to just below elbow. Had recv'd flu & pneumovax on 10/25/99.Tx on 10/26/99 w/Keflex, Solumedrol & Medrol Dose Pak.				Y					U	10/25/1999	10/26/1999	1	NONE	UNK	UNK			HTN,Hypothyroidism,GERD,previous reaction to ACE inhibitors w/angioedema	~ ()~~~In patient		1						1	Gastrointestinal disorder; Hypertension; Hypothyroidism; Oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0132846	12/27/1999	NM	39.0	39		F	12/09/1999	C/o pain around rt arm, including axilla starting about 11:30a on 12/8/99.Also c/o numbness rt little finger & 4th finger beginning 12/9/99.									Y	12/08/1999	12/08/1999	0	NONE	PUB	UNK	Synthroid,antibiotic	2 wks ago had URI & UTI	allergy to PCN,fibromyalgia,chronic fatigue syndrome,thyroid problems			1						1	Asthenia; Hypoaesthesia; Myalgia; Pain; Thyroid disorder	FLU3~PARKDALE PHARMACEUTICALS~02979P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~452374~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0132847	12/27/1999	CA	29.0	29		F	12/18/1999	Pt. dvlped tingling,sensory loss,& weakness in lt hand.This progressed to rt UE & lt UE on 11/14/99.On 11/16 it progressed to rt LE,11/18 progressed to lt LE.Tx w/ NSAIDs but still experiencing sensory loss & muscle weakness.				Y					N	10/29/1999	11/08/1999	10	EMG/NCV-11/19/99:early axonopathy w/ fast firing,complex motor units,decreased amplitudes,but normal durations.Brain MRI-normal	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Myasthenic syndrome; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~U0148AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0132848	12/27/1999		36.0	36		F	12/01/1999	Lt sided numbness and tingling after flu shot(occured 20 minutes after). Outcome described as neuropathy.									U	11/16/1999	11/16/1999	0	NONE	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Neuropathy; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132849	12/27/1999	CO	48.0	48		F	12/08/1999	Within 8 hrs of receiving vax,pt dvlped extreme weakness, tiredness,headache,muscle ache,loss of appetite,& fever;stayed in bed.These symptoms lasted 6 days;on 7th day felt less weak, took naps-this lasted until 12th day.									Y	11/22/1999	11/23/1999	1		PUB	OTH		NONE	allergy to aspirin	sick 1 day from flu vax in 1994.~ ()~~~In patient		1						1	Anorexia; Asthenia; Headache; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~301290~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0132854	12/27/1999	NM	39.0	39		M	12/15/1999	Rec'd Anthrax vax in rt upper arm on 12/13/99. Now has 17cm x 17cm red, indurated patch of skin surrounding injection site; very itchy.									Y	12/13/1999	12/14/1999	1	NONE	MIL	MIL	NONE	NONE	rt hand-carpal tunnel syndrome	Pt. experienced same symptoms to a previous Anthrax injection.~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Pruritus; Tenosynovitis	ANTH~MICHIGAN DEPT PUB HLTH~FAV031~4~SC~RA~ANTHRAX (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~U0169AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~CONNAUGHT LABORATORIES~7126AA~2~SC~LA~MENINGOCOCCAL (MENOMUNE)~1	USA		Influenza
0132864	12/27/1999	NH	58.0	58		F	11/17/1999	Started w/red,papular rash @ inj. site;spread to back of shoulder & down lt arm to elbow area.Pain scale 10 @ site;radiating down arm to fingers,numbness & tingling in fingers.Seen on 11/3 & still had rash,pain,& numbness.Tx w/Celestone				Y					N	10/28/1999	10/28/1999	0		PVT	PVT	NONE				NH9925	1						1	Injection site hypersensitivity; Injection site pain; Paraesthesia; Rash maculo-papular	FLU3~PFIZER\WYETH~4998228~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0132868	12/27/1999	MI	48.0			F	12/07/1999	Pt. recv'd flu vax around 4p.Chest tightness occurred approx 7p; lasting 3-4 hrs.									U	11/30/1999	11/30/1999	0	EKG-normal sinus rhythm	UNK	UNK			previous MI in 1991; cardiac cath. in 1995	~ ()~~~In patient		1						1	Chest pain	FLU3~PARKDALE PHARMACEUTICALS~02289P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0132870	12/27/1999	TX	48.0	48		F	11/22/1999	Red halo immediately following vax;increasing to total redness & swelling of upper arm w/hive-like areas.This was accompanied by nausea,vomiting & diarrhea.Tx was Benadryl.									Y	11/19/1999	11/20/1999	1	NONE	OTH	UNK	Synthroid	NONE	Hypothyroidism		99TX255	1						1	Hypothyroidism; Oedema; Urticaria; Vasodilatation; Vomiting	FLU3~PARKDALE PHARMACEUTICALS~00399P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0132046	12/28/1999	ND	68.0	68		M	11/23/1999	Within 24 hrs of vaccine, pt developed myalgia, arthralgias.He has since developed a large red erythematous hot rash and has difficulty moving L/elbow.The pt has some mild fluid in the olecranon bursa in the L/elbow. (See comments.)				Y					N	11/18/1999	11/19/1999	1		PVT	PVT	Zithromax, claritin		HTN, indigestion		ND9922	1						1	Arthralgia; Bursitis; Cellulitis; Dyspepsia; Hypersensitivity; Hypertension; Hypokinesia; Injection site hypersensitivity; Myalgia; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0163AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~465914~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0132047	12/28/1999	IL	81.0	81		M	12/02/1999	Puffiness to fave, looks like he had mumps - denied shortness of breath - trouble swallowing, sweats, Rx - Medrol and Claritin.				Y					Y	10/07/1999	10/08/1999	1	ANA blood test elevated at 640	PVT	PVT	Medrol, Claritin			~ ()~~~In patient		1						1	Antinuclear antibody; Dysphagia; Face oedema; Hyperhidrosis	FLU3~PFIZER\WYETH~4998214~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0132056	12/28/1999	MA	64.0	64		F	10/20/1999	Rt arm swelled, became hot & red. Sat. night arm hurt, Sun. developed full blown arm reaction. Tx w/ Cipro for 10 days.				Y					Y	10/16/1999	10/16/1999	0	NONE	PUB	PUB	Procardia, Liptor,Synthroid	NONE	allergy to Keflex, high blood pressure, hypothyroidism, high cholesterol	~ ()~~~In patient		1						1	Hypercholesterolaemia; Hypertension; Hypothyroidism; Oedema peripheral; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0107AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1095H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0132057	12/28/1999	MA	41.0			F	10/20/1999	Low grade temp. at 8:00a.m., 10-18-99. at 13:00 temp. 101.8.Palpitations,shortness of breath & vomiting.				Y					U					PVT	UNK		NONE				1						1	Dyspnoea; Palpitations; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U0107AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~462810~UNK~~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0132061	12/28/1999	NC	52.0	52		F	11/22/1999	Seizure with fever of 99.6, vomiting, heavy sweating, ct scan, U/A lab done.  Dilantin 100 mg given. Seizure activity started at 12:00 a.m. until morning.  Pt doesn't remember.				Y					U	11/19/1999	11/19/1999	0	Ct scan, U/A	PVT	PVT	Dilantin, premarin	NONE	NONE	~ ()~~~In patient		1						1	Febrile convulsion; Hyperhidrosis; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0152AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~U0152AA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0132065	12/28/1999	IL	51.0	51		F	11/24/1999	Pt had 1st flu shot 11/14/99, on 11/15/99, pt awoke with severe dizziness and nausea,  Pt unable to work.  Pt has never had dizziness with nausea in past.  Pt states has a sensative warm flush with infection.									Y	11/14/1999	11/15/1999	1	NONE	PUB	PVT	Estrace	NONE		~ ()~~~In patient		1						1	Dizziness; Nausea; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~V0163AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132068	12/28/1999	TX	64.0	64		F	11/02/1999	15 minutes after rec shots - felt dizzy like inner ear infection - 7:00 p.m. developed fever and chills, cold sweats, vomiting, nausea.  11/02 developed severe headache, r/arm very sore, not sure which shot was given in r/arm.									Y	11/01/1999	11/01/1999	0	NONE	OTH	PUB	Darvacet	NONE	Allergy to aspirin		99TX237	1						1	Dizziness; Headache; Hyperhidrosis; Hypersensitivity; Nausea; Pain; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~U01J0AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132069	12/28/1999	GA	31.0	31		F	12/02/1999	25 hours post vaccination, entire upper arm got swollen, red, tender and hot to touch.  Rx - benadryl, not taken because pt is nursing.									Y	10/26/1999	10/27/1999	1	NONE	PUB	PUB	Prenatal Vitamins	NONE		~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0132079	12/28/1999	TX	62.0	62		F	10/29/1999	Rt. upper arm red, swollen and warm to touch. Pt. states arm was also hard, yesterday, and had more swelling and pain at that time.									Y	10/27/1999	10/27/1999	0		PUB	PUB		NON-Hodgkins Lymphoma	NKDA	~ ()~~~In patient	99TX229	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Pseudo lymphoma; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0163AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0044J~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0132085	12/28/1999	TX	49.0	49		F	11/03/1999	Pt developed cold sores on mouth and lips and rash on face and neck on 11/3/99.  Pt had itching on face and neck with sneezing.  Pt saw a physician on 11/5/99, was given a prescription for antibiotics.									Y	10/28/1999	10/29/1999	1	NONE	PUB	OTH	Antibiotics	NONE	Predisposed to pollen allergies		99TX235	1						1	Hypersensitivity; Mouth ulceration; Pruritus; Rash; Rhinitis	FLU3~PFIZER\WYETH~4998243~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0132095	12/28/1999	TX	58.0	58		F	10/14/1999	Redness, swelling @ site spreading to axilla & lt breast area & then down inside of lt inner arm to elbow. Pt self administered oral Benadryl & used Benadryl ointment on site & reaction.									Y	10/11/1999	10/11/1999	0	NONE	PUB	PUB		NONE	allergies		99TX217	1						1	Injection site hypersensitivity; Injection site oedema; Oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0130AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132096	12/28/1999	TX	38.0	38		F	10/14/1999	10/9/99:Hives & itching on arms, legs, trunk, hair, & face. Pt took med that she had from 1995 for hives hydroxyzine pam.									Y	10/08/1999	10/09/1999	1		OTH	PVT	Synthroid, Rescon, nitrofurantoin	NONE	decrease thyroid function, food & environ. allergies,chronic bladder func.	~ ()~~~In patient		1						1	Cystitis; Pruritus; Thyroid disorder; Urticaria	FLU3~CONNAUGHT LABORATORIES~~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132099	12/28/1999	ME	48.0	48		F	11/24/1999	Feels like lt arm is asleep, mild tingling sensation at various locations on arm.Sensation happens at different times;she is able to move her arm.Hurt at site only during administration.										10/28/1999	11/02/1999	5	Blood work done 11/15/99	OTH	PVT	cholesterol meds, Lipitor?	NONE	high cholesterol	~ ()~~~In patient		1						1	Hypercholesterolaemia; Injection site pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~4998254~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132100	12/28/1999	VT	53.0	53		F	11/01/1999	By 4p on 10/19/99, pt had a raised,bright red welt approx 2 x 3 in diam;hot to the touch at inj. site,neck,shoulder, & lower back pain w/ accompying chills.The next day,sx worsened.Tx w/ Benadryl & cephalexin.				Y					U	10/19/1999	10/19/1999	0		PVT	PUB	Lipitor,albuterol,Xanax,prednisone,Ambien	NONE	asthma,hypertension,elevated cholestrol,MVP,osteoarthritis	~ ()~~~In patient		1						1	Asthma; Back pain; Chills; Dysphonia; Injection site hypersensitivity; Injection site mass; Neck pain; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~03179P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0132121	12/28/1999	PA	33.0	33		F	10/25/1999	Lunch time on 10/19/99, had headache, itchy injection site. Wed. a.m. not feeling great, headache. Wed. p.m. size of orange at site, wheezing & headache. Thursday, seen by PA & tx'd with ice to sight & Benadryl.				Y					Y	10/19/1999	10/19/1999	0	Serum sickness	OTH	OTH	Benadryl	NONE	Allergy Demerol, fish.   Pelvic Adhesive Disease	~ ()~~~In patient	PA9991	1						1	Asthma; Headache; Injection site hypersensitivity; Injection site mass; Malaise; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0156AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0132122	12/28/1999	PA	40.0	40		F	10/29/1999	Rcv'd flu shot, L arm hurt. Tounge felt heavy. Back of mouth & throat felt numb. 3pm, to Osteopathic ER. Allergic rxn, Benadryl 50mg. Swelling dec. 10/21 cold symptoms, vomiting, sore throat. 10/27 cold symp still exist, hives in throat.				Y					Y	10/20/1999	10/20/1999	0		OTH	OTH		NONE		~ ()~~~In patient	PA9983	1						1	Pain; Paraesthesia; Pharyngitis; Rhinitis; Tongue oedema; Urticaria; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0156AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0132123	12/28/1999	PA	26.0	26		F	10/25/1999	Generalized body pruritis, swelling of lips & face. Given Benadryl in ER.				Y					Y	10/21/1999	10/21/1999	0		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	PA9985	1						1	Face oedema; Pruritus	FLU3~PFIZER\WYETH~4988279~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0132133	12/28/1999	CT	39.0	39		F	11/26/1999	2 wks post/vax, right deltoid, 2cm abscess formed that required I & D. Patient was ill and nauseous. Grew out Staph on culture.				Y					Y	11/07/1999	11/10/1999	3	Wound Culture	MIL	MIL	NONE	NONE	NONE	~ ()~~~In patient		1						1	Infection; Injection site abscess; Malaise; Nausea	FLU3~CONNAUGHT LABORATORIES~U028~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0132135	12/28/1999	WI	49.0	49		F	11/09/1999	Unable to keep any liquid or food down (vomiting), temp. dropped to 96.6F//2000ml IV & shot for vomiting.				Y					Y	10/26/1999	10/26/1999	0		OTH	PVT		NONE	Asthma	~ ()~~~In patient		1						1	Hypothermia; Vomiting	FLU3~PARKDALE PHARMACEUTICALS~02779P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0132136	12/28/1999	GA	33.0	33		F	11/30/1999	Within 10-15 min. of vax, employee had dizziness, headache, numbness in hands & arms. BP 170/100, pulse 120, resp. 30. Lost consciousness & was taken by EMS to ER. Numbness in arms & hands slowly resolved x 1 week.				Y					Y	11/04/1999	11/04/1999	0	To be followed by private MD.	UNK	PVT	Prozac	Sinusitis	Childhood Asthma	~ ()~~~In patient		1						1	Dizziness; Headache; Hypertension; Hyperventilation; Paraesthesia; Syncope; Tachycardia	FLU3~PARKDALE PHARMACEUTICALS~01989P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0132141	12/28/1999	TN	44.0	44		F	11/17/1999	7P started feeling bad, 7:30P blurred vision. 11/13 had trouble sleeping & 7A found cluster of 3 knots behind rt ear. 12N knots larger, had ridge from rt ear up to head-pain. 3P went to ER and given Keflex & pain med. 11/14 am, knot behind				Y					Y	11/12/1999	11/12/1999	0	Drawn at hospital	PUB	PUB	mvi,carbo-iron, folic acid, vitamin E,B12, Fiber pills	NONE	Codeine, Buspor, Reflex Dystrophy Lt. arm & neck	~ ()~~~In patient	TN99047	1						1	Amblyopia; Insomnia; Lymphadenopathy; Malaise; Pain	DT~CONNAUGHT LTD.~1001536~4~IM~RA~DT ADSORBED (NO BRAND NAME)~1|FLU3~MEDEVA PHARMA, LTD.~E24849GA~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0132142	12/28/1999	CA	43.0	43		F	11/19/1999	Achey, swollen, red joints from fingers to toes, fatigue, chills, fever the next morning after flu vaccine. Given rx for Ibuprofen 800mg tid. Later, Nalofen.				Y					N	09/24/1999	09/27/1999	3	cbc,esr-30,hla-27,rf-neg,ana-neg,lyme titer-neg,ebv-neg,parvo-virus-neg	PVT	PVT	NONE	NONE	Allergic rhinitis, hushimoto's hypothyroidism	~ ()~~~In patient		1						1	Arthralgia; Asthenia; Osteoarthritis; Pyrexia	FLU3~PFIZER\WYETH~4998217~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0132143	12/28/1999	WA	52.0	52		F	10/27/1999	10/25 pm, noted redness around injection site.  10/26am, noted increased swelling and redness around injection site.  10/27am, noted extended redness & swelling 6x4 1/2.				Y					Y	10/25/1999	10/25/1999	0		OTH	PVT		? stomach flu 1 week previous	Food allergies of unknown type, causes hives.	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4998211~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0132145	12/28/1999	NY	21.0	21		M	12/02/1999	Rt-sided Bell's Palsy				Y					U	11/23/1999	11/27/1999	4	LYME-neg,  Serum Ace Level-normal	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Facial palsy	FLU3~CONNAUGHT LABORATORIES~U0200AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0132146	12/28/1999	IA	51.0	51		F	11/09/1999	About 1 hr. after vax, entire shoulder (injection site) hurt & accross the scapula & inside the armpit hurt (ached). Didn't sleep that night. 11/3/99, went to Dr. & he Dx: a bacterial infection from site of flu shot. Tx: 10-day Cedax 400mg.				Y					Y	11/02/1999	11/02/1999	0	NONE	PUB	PUB		NONE	Eczema	~ ()~~~In patient	IA99033	1						1	Injection site reaction; Insomnia; Pain	FLU3~CONNAUGHT LABORATORIES~U029AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0132149	12/28/1999	IN	16.0	16		M	11/17/1999	Pt given Hep B and pneumonia vax on 11/1/99.Sent to ER on 11/4/99 w/ red,raised, cellulitis-like injection site.Pt also had increased temp at home,diarrhea,cold chills beginning on 11/1/99.				Y					Y	11/01/1999	11/01/1999	0	CBC, Chem, Bood culture was negative	PVT	PVT	Prilosec	NONE	GERD	~ ()~~~In patient		1						1	Chills; Diarrhoea; Gastrointestinal disorder; Injection site hypersensitivity; Injection site mass; Pyrexia	FLU3~PFIZER\WYETH~4998225~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~MERCK & CO. INC.~18961H~1~IM A~~HEP B (RECOMBIVAX HB)~1|PPV~MERCK & CO. INC.~463015~1~IM A~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0132150	12/28/1999	IN	13.0	13		M	11/17/1999	Pt recv'd flu & pneumonia vax on 11/1/99.Later that evening, pt developed T102, swollen injection site, & knotted bulging cellulitis. Seen in ER on 11/4/99.				Y					Y	11/01/1999	11/01/1999	0	WBC-20.3, blood cultures are negative,Chem is negative	PVT	PVT	NONE	NONE	multiple drug allergies	~ ()~~~In patient		1						1	Cellulitis; Injection site mass; Injection site oedema; Leukocytosis; Pyrexia	FLU3~PFIZER\WYETH~4998225~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~MERCK & CO. INC.~1896H~2~IM A~~HEP B (RECOMBIVAX HB)~1|PPV~MERCK & CO. INC.~463015~1~IM A~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0132153	12/28/1999	CA	59.0	59		F	11/22/1999	Severe swelling,soreness,bruising to lt elbow, & nausea w/i 24 hrs of injection.Seen by MD & tx w/ Solu-Medrol w/ fair relief.On 11/22/99,pt still experiencing a moderate degree of swelling.				Y					Y	10/05/1999	10/06/1999	1	NONE	PUB	PUB	Delafan,Sudafed	NONE	severe environmental allergies, allergy to doxycycline;sulfa;& Benadryl		CA990144	1						1	Ecchymosis; Nausea; Oedema peripheral; Pain	FLU3~PFIZER\WYETH~4998216~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0132157	12/28/1999	PA	34.0	34		M	11/09/1999	Pt. reported tingling in hand, lasting 2-3 days. Then he noted painful swelling in index & middle finger on 11/1 that persists.									U	10/28/1999	10/28/1999	0		PUB	UNK	Tetracycline	Rosacea		~ ()~~~In patient	PA9982	1						1	Oedema peripheral; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4998279~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0132158	12/28/1999	FL	60.0	60		F	12/04/1999	Achy arm tender to touch and puffy. Breast area (R side) tender. Not feeling well. Tired, body ached, fingertips numb, cold weats, arm splotchy & remains tender to touch.  Called ER - rx cold compress w/ Ibuprophen.										12/02/1999	12/02/1999	0	NONE	PUB	PUB				~ ()~~~In patient		1						1	Asthenia; Breast pain; Hypoaesthesia; Myalgia; Oedema peripheral; Pain; Pyrexia; Rash maculo-papular	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0132161	12/28/1999	PA	52.0	52		F	10/25/1999	Had diarrhea for 3 days, still isn't right. Has pressure yet, afebrile, no other symptoms. Diarrhea started 10/20/99 in a.m. Took Lomotil.									Y	10/19/1999	10/20/1999	1		PUB	OTH	Estrogen/Premarin,provera	Sinus infection	Allergy-dust	~ ()~~~In patient	PA9992	1						1	Diarrhoea	FLU3~CONNAUGHT LABORATORIES~U0156AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132166	12/28/1999	MD	52.0	52		F	11/22/1999	Soreness began in left arm, immediately after injection & continued into the evening. Took Aleve & went to bed. It seemed to improve, however, on 11/15 or 11/16, it re-occurred with pain on lifting arm. On 11/18, neck stiffness developed.									Y	11/08/1999	11/08/1999	0	NONE	PUB	PUB	Hydroyx Urea, Flonase	NONE	Thrombocytopenia, Blood Disorder (too many platelets)	~ ()~~~In patient		1						1	Nuchal rigidity; Pain	FLU3~PARKDALE PHARMACEUTICALS~02289P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0132168	12/28/1999	LA	39.0	39		M	11/27/1999	Beginning 1 day after Flu shot, began to feel slightly dizzy and nauseous. I had already been having an allergy attack for 1 week or so. The dizziness and nausea continued intermittenly. It ceased 1 mo. later when cold weather arrived.									U	10/25/1999	10/26/1999	1	NONE	PUB	PUB		Allergy to mold in air				1						1	Dizziness; Hypersensitivity; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~UN~UN~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0132169	12/28/1999	CA	40.0	40		F	11/24/1999	Pain and redness over injection site, onset 7 hrs. after injections.									Y	11/12/1999	11/12/1999	0	NONE	PVT	OTH	Buspar,Ventolin,Restoril,Oxycontin,Wellbutin,Effexor,Zantac	Chronic back pain	Asthma			1						1	Injection site hypersensitivity; Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~02879P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|MMR~MERCK & CO. INC.~0130J~2~SC~GM~MEASLES + MUMPS + RUBELLA (MMR II)~1|PPV~PFIZER\WYETH~463013~1~IM~RA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~U0010AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0132171	12/28/1999	CT	39.0	38		F	11/30/1999	8 hrs. after vax., had papular rash on trunk and small amt. on head, slightly itchy. Few papules/painful on 2nd day. No vesicles. No other sx's. Mostly gone after 1 week.									Y	11/23/1999	11/23/1999	0		PUB	OTH	NONE	NONE	Seasonal allergies, sulfite sensitivity, Berger's disease, ? Lyme disease	~ ()~~~In patient		1						1	Pain; Pruritus; Rash maculo-papular	FLU3~PFIZER\WYETH~4998237~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0132178	12/28/1999	LA	86.0	86		F	10/29/1999	10/21 pt. called to report adverse rxn to injection she had in a.m. of 10/19. By that afternoon, rt arm pain & unable to use or lift left arm. By evening, arm was swollen from shoulder to elbow, all around. By 10/21, she is able to use arm,									Y	10/19/1999	10/19/1999	0		PUB	PVT	Prilosec, Bentyl, nerve pill	NONE	NONE	~ ()~~~In patient		1						1	Hypokinesia; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~40133AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1693H~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0132179	12/28/1999	CA	12.0	12		M	11/22/1999	Pt. c/o pruritus, red rash on rt. arm and stomach area. Denied any respiratory problems. No speech impairment.				Y					Y	11/19/1999	11/19/1999	0	Pt. escorted to Urgent Care for treatment.	UNK	UNK				~ ()~~~In patient		1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~U0166AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0132180	12/28/1999	OH	29.0	29		F		Sore arm/Ice & rest.   Lethargic, Nausea/Bland diet.									Y	11/22/1999	11/22/1999	0		OTH	PVT	Insulin	NONE	Diabetes, Depression	~ ()~~~In patient		1						1	Depression; Diabetes mellitus; Nausea; Pain; Somnolence	FLU3~PARKDALE PHARMACEUTICALS~02189P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0132182	12/28/1999	MI	65.0	65		F	11/18/1999	Initial soreness followed by increased soreness, 11/17/99. Swelling in deltoid region, slight redness. 11/22/99 states that soreness is improving.									Y	11/16/1999	11/17/1999	1		PUB	PUB	Sectrol,Premarin,Synthroid, Diafide	NONE	NONE	~ ()~~~In patient	MI-99-132	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4998245~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0043J~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0132183	12/28/1999	WA	52.0	52		M	11/09/1999	Swelling, redness and firmness at injection site, immediately following injection.									Y	11/03/1999	11/03/1999	0		OTH	OTH	ASA Therapy	NONE		~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~PFIZER\WYETH~4998211~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0132184	12/28/1999	WA	57.0	57		M	11/04/1999	Redness, swelling, hard area surrounding injection site, approx. 1 1/2 area.									Y	11/03/1999	11/03/1999	0		OTH	OTH	ASA	ASA Therapy	Horse Serum	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~PFIZER\WYETH~4998211~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0132185	12/28/1999	WA	43.0	43		F	11/09/1999	Redness, tenderness, at injection site. Raised (similar to bee sting) and hot. Decreased ability to rotate arm. Took Tylenol and benadryl. Sx's took wks to resolve, still sore in finger joints.									Y	11/03/1999	11/03/1999	0		OTH	OTH	NONE (vitamins)	NONE	Sulfurs, walnuts, ?dust	~ ()~~~In patient		1						1	Arthralgia; Hypokinesia; Injection site hypersensitivity; Injection site mass; Injection site pain; Vasodilatation	FLU3~PFIZER\WYETH~4998211~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0132186	12/28/1999	WA	22.0	22		F	11/09/1999	C/o warmth, redness at injection site; weakness in hand/arm/fingers, approx. 5 mins. after vaccine. Ice applied to site. 11/4/99 a.m., reports sx's resolved.									Y	11/03/1999	11/03/1999	0		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Myasthenic syndrome; Vasodilatation	FLU3~PFIZER\WYETH~4998211~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0132191	12/28/1999	VA	33.0	33		F	12/01/1999	Pt. experienced mod. localized reaction to rt. arm; lump the size of an Oreo cookie, with redness and heat from the area. Also, had itching/mild tingling. Tx'd at home w/anti-inflammatories and cool compresses.									Y	11/29/1999	11/29/1999	0		PUB	PUB	Claritin, Prilosec	Bell's Palsy-occurred mid 11/99	Environmental allergies-Dust mites	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Paraesthesia; Pruritus; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02089P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0132192	12/28/1999	NY	73.0	73		F	11/30/1999	Next day after shot, left arm swollen; hard to raise arm, sore. She had Pneumonia shot on 11/8/99 and at this time, 11/20/99, she still has severe pain.									Y	10/22/1999	10/22/1999	0	NONE	PUB	PUB	Motrin	NONE		~ ()~~~In patient		1						1	Hypokinesia; Injection site oedema; Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~00499P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0132195	12/28/1999	VA	35.0	35		F	11/05/1999	Red area 5cmx3.5cm, slightly raised and hot over deltoid muscle. Started 48 hrs. after vax. Pain more over inject. site, but radiates down rt arm & up into neck. Tx:Ice pk. today. Ice & heat after today. Ibuprofen 200mg, 2-3 tab. every 6 hr									Y	11/03/1999	11/04/1999	1		PVT	PVT	Prozac, Prilosec,Remeron	NONE		~ ()~~~In patient	VA99065	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Neck pain; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0110AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132196	12/28/1999	CA	64.0	64		F	11/15/1999	c/o Blurred vision, chest discomfort and very anxious. B/P 184/98 at 12:49. OJ given and pt. stated did not take B/P meds. as prescribed this a.m. Took B/P over, while resting in clinic, 1:05pm. B/P 164/86.									Y	11/15/1999	11/15/1999	0		PUB	PUB	Insulin, ?	Diabetes, Hypertension			CA990145	1						1	Amblyopia; Anxiety; Chest pain; Diabetes mellitus; Hypertension	FLU3~MEDEVA PHARMA, LTD.~30889KA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0132197	12/28/1999	VA	33.0	33		M	11/16/1999	10/26/99-Pain lwr. rt. arm, soreness lwr. radial side. Could not turn door key & tie shoes. 10/28/99-discoloration, like a bruise. No problem in injection site at upper arm. 11/15/99 pt. much improved.									Y	10/25/1999	10/26/1999	1	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	VA99066	1						1	Ecchymosis; Hypokinesia; Pain	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~CONNAUGHT LABORATORIES~U0003BA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0132253	12/28/1999	OK	75.0	74		F	10/27/1999	Approx. 1-1 1/2 hrs. after pt. rec'd flu vax., she returned to site w/whelps on both arms. Referred to PMD for evaluation and tx.				Y					Y	10/25/1999	10/25/1999	0	NONE	PUB	PUB	Macrobid,Propulsid,Diovan,Leubid,Impramine,Ambien,Pravachol	NONE	Hypertension,Bladder spasms,Hypercholesteremia		OK9954	1						1	Urticaria	FLU3~PARKDALE PHARMACEUTICALS~02089P~3~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0132260	12/28/1999	SC	60.0	60		F	12/02/1999	On 11/17/99, pt. had pain in arm. On 11/18/99, was red on arm where shot was given. On 11/21/99, had low grade fever. Seen by MD on 11/22/99, clinical dx, staff infection. Given IV antibiotics.				Y					Y	11/16/1999	11/17/1999	1		OTH	OTH			Diabetes			1						1	Diabetes mellitus; Pain; Pyrexia	DTP~LEDERLE LABORATORIES~463321~UNK~IM~LA~DTP (TRI-IMMUNOL)~1|FLU3~CONNAUGHT LABORATORIES~U0270AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0132261	12/28/1999	VT	23.0	23		F	11/05/1999	Vax. at worksite, continued at job, 3 1/2 hrs. later felt like throat had something stuck in it, felt constricted. Tongue felt tingly and thick. Felt flush, skin on chest, legs & arms was mottled, but not described as hives. Left arm at				Y					Y	11/03/1999	11/03/1999	0	NONE	OTH	PVT	NONE	NONE	Allergy to tea tree oil, Asthma	~ ()~~~In patient	VT99008	1						1	Hypertonia; Injection site hypersensitivity; Injection site pain; Laryngospasm; Tongue oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0104AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0132264	12/28/1999	MO				F	12/02/1999	Swollen arm, where vaccine was given and red and hot.				Y					Y	10/09/1999	10/10/1999	1	Given Solumedrol injection/125mg	PUB	PVT		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0128AA~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0132266	12/28/1999	WI	69.0	69		F	11/08/1999	Pt. developed swelling, the size of 1/2 orange, at injection site, with area of redness and warmth down to elbow, which lasted about 3 days.									Y	10/29/1999	10/29/1999	0		PUB	PVT	Lopressor, Premarin	NONE	Hypertension		WI99035	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4998257~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0132268	12/28/1999	OK	35.0	35		M	11/03/1999	Generalized hives, throat & ear swelling.									Y	10/29/1999	10/29/1999	0	NONE	PUB	PUB	NONE	NONE	NONE		OK9959	1						1	Face oedema; Laryngospasm; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~02089P~5~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0132272	12/28/1999	FL	52.0	51		U	11/29/1999	Systemic rash, maculopapular, on trunk, arms, neck, scalp, thighs and calves lasting 5 to 6 days. Also, pruritic. Tx-Benadryl.									Y	11/02/1999	11/03/1999	1		OTH	PVT	Vitamins only	NONE	NO allergies, Rheumatic Fever @ age 12, Splenectomy @ age 14	~ ()~~~In patient		1						1	Pruritus; Rash maculo-papular	FLU3~PFIZER\WYETH~4998290~6~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0132278	12/28/1999	MN	2.0	2	.9	F	12/02/1999	Due for 2nd flu shot today. Call to parent because of no show and parent stated child was ill & vomiting after recvg. 1st flu shot, and lasted a week. Parent questioning a reaction to the vax. Did take child to DR. Will not cont. series.									Y	10/28/1999	10/29/1999	1	Had a WBC & urine test	PUB	PUB	Asthma med	NONE	NONE	~ ()~~~In patient	MN99024	1						1	Malaise; Vomiting	FLU3~PFIZER\WYETH~4998285~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0132279	12/28/1999	CA	42.0	42		F	11/22/1999	Received flu shot about 11:00 am, by 4:00 pm, the same day, I started to get red raised hives on my arms & by 8:00 pm they were over my entire body. Itching began and the hives raised up and I felt feverous.									Y	10/26/1999	10/26/1999	0		UNK	UNK				~ ()~~~In patient		1						1	Pruritus; Pyrexia; Urticaria; Vasodilatation	FLU3~PFIZER\WYETH~4998241~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0132280	12/28/1999	MN	5.0	5		M	12/02/1999	Was due for 2nd flu shot today. Called because of no show, parent stated wasn't coming because he was ill & vomiting for a week after getting 1st flu shot. Was questioning a reaction to the 1st vax & will not be continuing the series.									Y	10/28/1999	10/29/1999	1	NONE	PUB	PUB	Asthma med	NONE	NONE	~ ()~~~In patient	MN99023	1						1	Malaise; Vomiting	FLU3~PFIZER\WYETH~4998285~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0132282	12/28/1999	AZ	68.0	67		F	11/26/1999	Pt. was given flu shot & Pnumovax on 11/8/99. Arm where Pnumovax was given, became swollen and site was painful x 2-3 days. Applied ice pk. & edema & pain gradually resolved over one weeks time.									Y	11/08/1999	11/08/1999	0	NONE	PVT	PVT	Premarin, Provera	NONE	NKDA-does have hay fever, Colon-CA, Lung-CA	~ ()~~~In patient		1						1	Gastrointestinal carcinoma; Injection site oedema; Injection site pain; Lung neoplasm malignant	FLU3~PFIZER\WYETH~4498287~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0043J~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0132284	12/28/1999	IN	65.0	65		F	11/12/1999	L arm red & swollen to her elbow and into her axilla.									Y	11/10/1999	11/11/1999	1	NONE	PVT	UNK	Premarin, enalapril, Provera, Zoloft, albuterol tabs	NONE	Allergies: PCN, NSAIDS, HCTZ, Iron Streptomycin			1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~40155AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~459038~UNK~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0132287	12/28/1999	HI	46.0	46		F	12/01/1999	Feelings of a pitched nerve in lt deltoid where flu shot was given initially; now muscle spasm & tenderness 11/29/99.Tx w/ physical therapy.									N	11/17/1999	11/23/1999	6	NONE	OTH	PVT	UNK	UNK	UNK	~ ()~~~In patient		1						1	Hypertonia; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0132288	12/28/1999	OH	36.0	36		M	11/19/1999	Recv'd flu vax on 11/17/99 in the morning.On the evening of 11/18/99, pt started to experience bilateral swelling of both hands up to 2 above wrist.									Y	11/17/1999	11/18/1999	1	PPD-lot #-2517-11	PUB	UNK		NONE		~ ()~~~In patient		1						1	Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~U0149DA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132290	12/28/1999	LA	69.0	69		F	11/24/1999	Red rash from injection site to below elbow; itching down to hand by 2 hrs post injection. Itching stopped after 24 hrs.									Y	11/23/1999	11/23/1999	0		PUB	OTH		NONE	sinus problems; allergy to Vit.C	~ ()~~~In patient	LA991201	1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0167AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0871H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0132296	12/28/1999	NC	23.0	23		F	11/23/1999	Pt recv'd her 1st flu shot on 11/17/99.Later that evening, she dvlped sore throat, chills on & off, & tight chest when breathing. Seen by her MD on 11/18/99, who stated she was experiencing normal sx to the flu shot.				Y					U	11/17/1999	11/17/1999	0		OTH	OTH	Septra			~ ()~~~In patient		1						1	Chest pain; Chills; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~U0134EA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0132299	12/28/1999	WI	39.0	39		F	10/28/1999	Within 24 hrs of administration of flu vax, developed area 4 1/2 x 5 cm of swelling, redness & warmth of injection site. Resolved within 48 hours.									Y	10/26/1999	10/26/1999	0		PUB	PVT		NONE		~ ()~~~In patient	WI99034	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PFIZER\WYETH~4998257~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0132300	12/28/1999	WI	51.0	51		F	10/29/1999	Area 3x2 at injection site, red, swollen, itchy, moderately painful.									Y	10/25/1999	10/26/1999	1		PVT	UNK				~ ()~~~In patient	WI99031	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0096EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132302	12/28/1999	WI	29.0	29		F	10/21/1999	Redness around injection site, approx 3 in diameter.Pt also has itching of arm.									Y	10/18/1999	10/18/1999	0		PUB	UNK		NONE	NONE		WI99029	1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~4998260~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0132303	12/28/1999	IA	60.0	60		F	11/04/1999	Rcv'd. shot on Wed. & on Fri. had periods of heavy sweating with any activity. Ran a fever of 99.4 to 100.9. Went to Dr on Monday & everything was clear. Tx'd w/Motrin. The hot sweats lasted over 1 week.									Y	10/01/1999	10/03/1999	2		PUB	PVT		Fibromyalgia	Sulfa	~ ()~~~In patient		1						1	Hyperhidrosis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0132317	12/28/1999	ND				M	12/07/1999	Hives-severe & prolonged requiring several trips to MD for antihistamine tx.The hives are described as generalized and persistant.				Y					Y				NONE	UNK	UNK				~ ()~~~In patient		1						1	Urticaria	ANTH~MICHIGAN DEPT PUB HLTH~FAV031~2~SC~RA~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0132319	12/28/1999	VA	41.0	41		F	11/22/1999	1-2 hrs after vax, arm swelling, had heaviness in chest, nausea, throat felt swollen. Then, began w/headache, abd. pain. Fever began 11/20/99 also, and is 102F today. Today, left uppr arm laterally is warm, swollen and tender.				Y					Y	11/20/1999	11/20/1999	0	11/23/99 Seen in ER-dx'd with Strept Throat	PUB	PUB	Glucophage, Synthoid	NONE	Diabetes, Hypothyroidism, Pcn allergy		VA99067	1						1	Abdominal pain; Chest pain; Headache; Injection site hypersensitivity; Injection site oedema; Injection site pain; Laryngospasm; Nausea; Oedema peripheral; Pyrexia; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02289P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~463021~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0132323	12/28/1999	MI	72.0	72		M	10/14/1999	Experienced weakness of the left arm. He was unable to lift his arm.  On 10/14/99, the strength in his left arm started to return.									Y	10/13/1999	10/13/1999	0	CT Scan done 10/13/99 and was negative.	PUB	UNK	Aspirin,Nitro-Bid,Prilosec,Propulsid,Multi-Vitamins	NONE	CAD	~ ()~~~In patient		1						1	Hypokinesia; Myasthenic syndrome	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1402H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0132599	12/28/1999	CA	43.0	43		F		Tingling on arms,leg & face 2 days after vax.5 days later,prickling, tingling in feet;numbness in lower legs & feet.Symptoms have slowly subsided.Dx w/ post-vaccinal paresthesia/neuritis.				Y						11/05/1999	11/08/1999	3	increase ANA, decrease C3,C4	PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						2	Neuritis; Paraesthesia; Neuritis; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~U0102AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0102AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0132753	12/28/1999	NE	8.0	8		F	12/13/1999	Had flue shot 12/9/99.  On 12/10/99, l/arm injection site was hard and swollen.  Itching at school.  Went to nurse and she said there were hives around the site.  Hives were gone 12/10/99.  Told she shouldn't get the flu vaccine again.				Y					Y	12/09/1999	12/10/1999	1		PVT	PVT	NONE	NONE	Febrile seizures	~ ()~~~In patient		1						1	Febrile convulsion; Injection site hypersensitivity; Injection site mass; Injection site oedema; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4998422~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0132756	12/28/1999	OR	1.5	1	.5	M	12/09/1999	7 X 12 cm erythema, induration on rt thigh surrounding injection site; slightly tender but walking, running, climbing w/o problems.									Y	12/08/1999	12/09/1999	1		PVT	UNK	NONE	NONE	atopic dermatitis	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	DTAP~CONNAUGHT LABORATORIES~U0008BA~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~CONNAUGHT LABORATORIES~U0063AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~CONNAUGHT LABORATORIES~UA474AA~4~IM~RL~HIB (PROHIBIT)~1	USA		Influenza
0132757	12/28/1999	PA	7.0	7		F	12/11/1999	3 x 4 raised erythematous lesion on lt lateral arm;positive for warmth & positive for tenderness.									U	12/10/1999	12/11/1999	1	NONE	PVT	UNK		NONE	asthma,allergic rhinitis	~ ()~~~In patient		1						1	Asthma; Pain; Rash; Rhinitis; Skin ulcer; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0144AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132758	12/28/1999	FL	49.0	49		F	12/08/1999	Swollen glands on both sides under my chin & down the front & back of my neck.Fever 101-102,night sweats,headache,body aches,& redness on legs up to my knees.Took ibuprofen w/o relief.Went to ER & tx w/ antibiotics.				Y					Y	10/22/1999	10/28/1999	6		MIL	MIL	Synthroid,oxazepam,Tegretol	NONE	hypothyroidism,bi-polar disorder	~ ()~~~In patient		1						1	Headache; Hyperhidrosis; Lymphadenopathy; Myalgia; Pyrexia; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0132767	12/28/1999	CA	30.0	30		F	12/15/1999	Pt. had vaccine w/ 3 other people & each of them got the flu a few wks later & it lasted about 2-3 wks.It seems the shot was out-dated.									Y	11/10/1999	11/25/1999	15		OTH	OTH				~ ()~~~In patient		1						1	Drug ineffective; Infection; Influenza	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0132771	12/28/1999	CA	2.0	2	.3	M	12/14/1999	Rt anterior thigh w/ 6 x 6 cm redness & induration.Pt limping,fever 101 for 2 days.				Y					Y	12/08/1999	12/09/1999	1		PVT	PVT	NONE	flu symptoms,otitis media	hx of allergic colitis 6/99; GERD 6/99; poor weight gain			1						1	Colitis; Gastrointestinal disorder; Influenza; Injection site hypersensitivity; Injection site mass; Otitis media; Pyrexia; Weight increased	FLU3~PFIZER\WYETH~4998251~1~IM~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~465896~1~IM~RL~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0132791	12/28/1999	AR	1.5	1	.5	M	11/09/1999	3 x 4 cm area of hot & red area deltoid area post 11/5/99 DTAP. Pt was given antibiotics per PMD.Dxed w/ unspecified cellulitis.				Y					U	11/05/1999	11/05/1999	0		PUB	OTH	antibiotic	NONE	Takes nightly dose of maintenance dose of antibiotic to prevent OM		AR9955	1						1	Cellulitis; Injection site hypersensitivity; Vasodilatation	DTAP~SMITHKLINE BEECHAM~912A2~4~IM~RA~DTAP (INFANRIX)~1|FLU3~CONNAUGHT LABORATORIES~UO165AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0132795	12/28/1999	PR	53.0	53		F	12/21/1999	Itching all over trunk,arms, & hands w/ red sunburn like rash,onset 9p on 12/17/99.Tx on 12/18 w/ oral Benadryl w/ no relief.Cont'd Benadryl thru 12/20 w/ no abatement of symptoms.Seen by MD who plans Decadron therapy.				Y					N	12/17/1999	12/17/1999	0		PVT	PUB	Prim-Pro, Flexeril	NONE	cervical back pain	Pt dvlped a rash following a flu shot when he was 52.~ ()~~~In patient		1						1	Neck pain; Pruritus; Rash	FLU3~PFIZER\WYETH~4998238~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~459041~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0132797	12/28/1999	ID	49.0	49		F	11/06/1999	Peripheral blurred vision; pt called MD-was better before leaving his office.									Y	11/06/1998	11/06/1998	0		PUB	UNK	chemotherapy		abdominal cancer		ID99051	1						1	Neoplasm malignant; Visual field defect	FLU3~PFIZER\WYETH~4988200~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0129926	12/29/1999	NE	36.0	35		F	10/18/1999	Received Flu shot on thursday 10/15/99 in L/arm. L/arm hurt thoughout weekend. On 10/17/99, began to develope flu-symptoms; cold chills, sweats, achy body, n/v, headache and light headed.									U	10/15/1999	10/17/1999	2		PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						2	Chills; Dizziness; Headache; Hyperhidrosis; Injection site pain; Myalgia; Vomiting; Chills; Dizziness; Headache; Hyperhidrosis; Influenza; Myalgia; Pain; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0129AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0129AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0130232	12/29/1999	MI	1.0	1	.0	F	11/22/1999	Gross hematuria.				Y					U	10/26/1999	11/10/1999	15	UA 3+ blood, 250 rbc, lt LE -, culture -	PVT	UNK		NONE	Prematurity (29 weeks)	~ ()~~~In patient		1						2	Unevaluable event; Anaemia; Haematuria; Premature labour	FLU3~PARKDALE PHARMACEUTICALS~02879P~UNK~~RL~INFLUENZA (SEASONAL) (FLUOGEN)~1|IPV~CONNAUGHT LTD.~P05522~4~~LL~POLIO VIRUS, INACT. (POLIOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0131036	12/29/1999	AZ	72.0	72		M	11/09/1999	Rt. upper arm, hot, swollen,hard-unable to move arm at all. On 11/8, movement improved. On 11/9, erythema, edema moved to lower rt. arm. Movement improved. Pt. is Diabetic.									N	11/06/1999	11/07/1999	1		UNK	UNK	Glucophage,Coumadin,ASA,Lanoxin,Lipitor,Avandia,Glynase,Zantac	Was Well	Diabetic-No allergies	~ ()~~~In patient		1						2	Hypokinesia; Injection site hypersensitivity; Injection site mass; Injection site oedema; Oedema peripheral; Rash; Hypokinesia; Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~~RA~PNEUMO (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~~2~~RA~PNEUMO (NO BRAND NAME)~2	USA		Influenza
0131713	12/29/1999	OR	72.0	72		F	11/10/1999	none stated				Y					Y	10/28/1999	10/28/1999	0		OTH	OTH	Atenolol; PREMARIN; Thyroid	NONE	List upon request	NONE~ ()~~0.00~Patient		1						1	Anorexia; Asthenia; Asthma; Chills; Cough; Dizziness; Dyspnoea; Laryngospasm; Pyrexia; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~GM~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0131715	12/29/1999	IA	55.0	55		F	11/05/1999	3 hrs post vax, pt R arm (pneumo vac site) began to hurt, well & turn red. Last 2 fingers on R hand were numb. Pt felt hot & cold but didn't ck temp. Symptoms persisted for 5 days. Advised not to have additional pneumonia vaccines.				Y					Y	10/27/1999	10/27/1999	0	NONE	PUB	PUB	NONE	NONE	Allergies: dust, PNC	~ ()~~~In patient		1						1	Chills; Injection site hypersensitivity; Injection site oedema; Injection site pain; Paraesthesia; Unevaluable event	FLU3~CONNAUGHT LABORATORIES~U0134AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0870H~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~CONNAUGHT LABORATORIES~U0134AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0870H~UNK~~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0131715	12/29/1999	IA	55.0			F	11/01/1999	Pt called health dept 10/28/99. She was referred by RN, to her private physician.									Y	10/27/1999	10/27/1999	0		PUB	OTH				~ ()~~~In patient		1						2	Chills; Injection site hypersensitivity; Injection site oedema; Injection site pain; Paraesthesia; Unevaluable event	FLU3~CONNAUGHT LABORATORIES~U0134AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0870H~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~CONNAUGHT LABORATORIES~U0134AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0870H~UNK~~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0131721	12/29/1999	RI	2.0	2	.1	M	10/29/1999	Local erythema & warmth medial to injection site.									U	10/28/1999	10/29/1999	1	NONE	PVT	UNK	albuterol	NONE	asthma	~ ()~~~In patient		1						1	Asthma; Injection site hypersensitivity; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0131AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131722	12/29/1999	PA	51.0	51		F	11/01/1999	Nausea, fatigue, pruritic rash, starting day after vaccine administered.				Y					Y	10/27/1999	10/28/1999	1		PUB	PVT	Prilosec, Premarin	NONE	Penicillin	~ ()~~~In patient		1						1	Asthenia; Nausea; Pruritus; Rash	FLU3~PARKDALE PHARMACEUTICALS~03279P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0131723	12/29/1999	NV	43.0	43		F	11/02/1999	Arthralgia, general myalgia.				Y					N	10/06/1999	10/06/1999	0	NONE	PUB	PVT	Nortriptaline 20mg, Imitrex as needed		Allergies: Demerol	~ ()~~~In patient		1						1	Arthralgia; Myalgia	FLU3~PFIZER\WYETH~4998259~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0131724	12/29/1999	MI	57.0	57		F	11/03/1999	R/arm sore after shot. Within 24 hrs, arm was red, hot, swollen to twice it's normal size. Med provider ordered Benadryl & ice packs for 24 hrs, followed by heat which began on Monday. Above symptoms, resolving.				Y					Y	10/29/1999	10/30/1999	1	NONE	PUB	PUB	NONE			~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~02989P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~466445~1~~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0131725	12/29/1999	MN	7.0	7		M	10/18/1999	Large local reaction - hive from tip of shoulder to elbow.				Y					Y	10/14/1999	10/15/1999	1	NONE	PVT	PVT		NONE	Premature birth - mild cp - mild intermittent RAD	~ ()~~~In patient		1						1	Asthma; Chest pain; Injection site reaction; Premature labour; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~02879P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0131731	12/29/1999	AK	29.0	29		M	11/22/1999	Induration, pain, swelling and redness.				Y					Y	11/17/1999	11/18/1999	1		PUB	UNK		NONE	Asthma, environmental allergies	~ ()~~~In patient		1						1	Asthma; Oedema; Pain; Skin nodule; Vasodilatation	FLU3~PFIZER\WYETH~4998209~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~459837~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0131733	12/29/1999	KY	35.0	35		F	10/28/1999	Itching/rash				Y					Y	10/28/1999	10/28/1999	0		PUB	PVT		NONE	Erythromycin, Reflux,  Irritible bowel	~ ()~~~In patient		1						1	Gastrointestinal disorder; Pruritus; Rash	FLU3~PFIZER\WYETH~4998217~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0131734	12/29/1999	MD	55.0	55		F	11/04/1999	General body aches, fever to 101.3, chills, severe pain & weakness with some swelling in both legs; walking limited. Reaction began Fri, 10/22, improvement began Tues, 10/26. Took Ibuprofen & fluids.				Y					Y	10/18/1999	10/22/1999	4	NONE	PVT	PVT	HRT, Calcium, Vitamins	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Hypokinesia; Myalgia; Oedema peripheral; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4998209~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0131736	12/29/1999	NC	37.0	37		F	11/03/1999	Weakness all over body, itching at site of injection, feeling of heaviness and light headed. Light headed feeling 15-20 minutes after influenza vaccine.				Y					Y	11/02/1999	11/02/1999	0	NONE	OTH	MIL	NONE	NONE	G6PD defic	~ ()~~~In patient		1						1	Dizziness; Injection site hypersensitivity; Myasthenic syndrome; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0168AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0131743	12/29/1999	IA	47.0	47		F	11/01/1999	Hives, difficulty breathing. Legs weak, caving in when tried to walk.				Y					Y	11/04/1998	11/04/1998	0	NONE	PVT	PVT			Diabeties, Allergy to Latex, Dye used for kidney ultrasound 1 day prior	~ ()~~~In patient		1						1	Dyspnoea; Myasthenic syndrome; Urticaria	FLU3~CONNAUGHT LABORATORIES~09883000~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0131744	12/29/1999	AR	40.0	40		M	11/01/1999	Acute onset Dense Bell's Palsy R side of leg less than 24 hours after flu shot.				Y						10/22/1999	10/22/1999	0	Paralysis, Facial	PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Facial palsy	FLUX~UNKNOWN MANUFACTURER~U0157AA~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0131745	12/29/1999	OH	40.0	40		M	11/04/1999	Exp loss of conciousness, diaphoresis, nausea. Onset 2 minutes after immunization. Hyptensive.				Y					Y	11/04/1999	11/04/1999	0		OTH	PVT				~ ()~~~In patient		1						1	Hyperhidrosis; Hypotension; Nausea; Syncope	FLU3~CONNAUGHT LABORATORIES~U0156AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0131748	12/29/1999	SC	57.0	57		F	11/01/1999	Swelling at site, pain, axillary & supraclevicular adenopathy.				Y					U	10/26/1999	10/27/1999	1	NONE	PVT	PVT	Captopril, Premarin	NONE	RENAL INSUFFCIENCY	~ ()~~~In patient		1						1	Injection site oedema; Injection site pain; Lymphadenopathy; Renal impairment	FLU3~PARKDALE PHARMACEUTICALS~00499P~4~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0131755	12/29/1999	IN	42.0	42		F	11/19/1999	Sharp pains in chest, nausea, sweating, knot in chest (soreness still there), numbness in hands & feet, sob, fash heartbeat. Still have sob & fast heartbeat, at times.				Y					N	10/28/1999	10/28/1999	0	EKG-Neg, UPPER GI-don't know results	OTH	OTH	Macrobid	NONE	Have had bladder infection, been on Macrobid since Dec, 1998	~ ()~~~In patient		1						1	Chest pain; Cystitis; Dyspnoea; Hyperhidrosis; Nausea; Paraesthesia; Skin nodule; Tachycardia	FLU3~PARKDALE PHARMACEUTICALS~00199P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0131756	12/29/1999	MA	44.0	44		F	10/22/1999	At 5:50 pm, TB felt pain(mod-severe) in L/arm (deltoid area). Over the next 1-2 hrs she experienced itchiness, rash, swollen face, difficulty breathing & wheezing. Went to ER 11:00 pm, given Solumedrol & Benadryl & Nebulizer Rx & released.				Y					Y	10/21/1999	10/21/1999	0	NONE	OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Asthma; Dyspnoea; Face oedema; Injection site pain; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~U0156AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0131757	12/29/1999	DC	38.0	38		M	10/28/1999	C/o dizziness 5 mins after receiving Flu injection. BP R/arm 80/50; diaphoretic; A+Dx3; stat loss of concscious, regained consciousness after ammonia & 0.5 cc Epinephrited given SC L/arm stat. Placed in Trendelenberg position after O2				Y					Y	10/28/1999	10/28/1999	0		PUB	OTH		NONE	Denies hx of allergies, med cond.	~ ()~~~In patient		1						1	Dizziness; Hyperhidrosis; Hypotension; Syncope	FLU3~PFIZER\WYETH~4998344~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0131758	12/29/1999	MA	69.0	69		F	10/31/1999	Rash, swelling, tenderness from knee to toes on both legs. Rash was red & splotchy.				Y					U	10/08/1999	10/09/1999	1	2 blood tests & 1 more scheduled	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Oedema peripheral; Pain; Rash	FLU3~CONNAUGHT LABORATORIES~U0107AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0131760	12/29/1999	OH	42.0	42		M		Rash, itching & burning, started approx 4 hrs after administration. Within 24 hrs, erythemous, macular papular rash with epidermal sloughing, involving axillary region. Rx'd Depmedrol 80mg/IM and Atarax 25mg/po.				Y					Y	11/08/1999	11/08/1999	0		PVT	OTH	Norvase, Toprol	NONE	Hx of Migraines, Colitis, Hypertension	~ ()~~~In patient		1						1	Colitis; Dermatitis exfoliative; Hypertension; Migraine; Pain; Pruritus; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~U0160AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0878J~2~IM~RA~HEP B (RECOMBIVAX HB)~1	USA	Emergency room visit	Influenza
0131763	12/29/1999	VA	45.0	45		M	11/19/1999	Devel goose egg size swelling at site of inject. Tiredness, nausea, malaise w/in 8 hrs after. Then erythema, warm to touch at 20-48 hrs after. Right deltoid.				Y					Y	11/16/1999	11/16/1999	0	NONE	OTH	OTH	Glucophage 500 BID, Naproxen 500 BID	NONE	DM	~ ()~~~In patient		1						1	Injection site mass; Injection site oedema; Injection site pain; Malaise; Nausea; Rash; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~004499P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1585H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0131764	12/29/1999	PA	50.0	50		F	11/18/1999	Localized reaction at site, (erythema), shortness of breath. Pt presented days after vaccine occurred and has Asthma Hx.				Y					Y	11/10/1999				PVT	PVT	Amaryl, Glucaphage, Humalin, Es trace, Proventil, Meridia	Acute Sinusitis, Asthma	IDDM, Ashtma, Hysterectomy	~ ()~~~In patient		1						1	Asthma; Diabetes mellitus; Dyspnoea; Injection site hypersensitivity; Sinusitis	FLU3~PFIZER\WYETH~4998237~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~PFIZER\WYETH~4998302~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0131769	12/29/1999	OH	57.0	57		M	11/19/1999	Approximately 3 hrs after receiving the flu vaccine, pt experienced flushing, elevated BP, chest & throat congestion & pleuritic chest pain. All responded to Benadryl 50mg/Im.				Y					Y	11/12/1999	11/12/1999	0		OTH	PUB	Norvasc	NONE	HBP	~ ()~~~In patient		1						1	Chest pain; Hypertension; Pharyngitis; Rhinitis; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0136AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0131770	12/29/1999	MO	14.0	14		M	11/03/1999	Vasculitis-non-blanching rash on entire body except face x 3 days.				Y					U	10/21/1999	11/01/1999	11		PVT	PUB	Ritalin, Paxil, Trazadone, Allegra, Rhinocort, Patanol		Mild Mitral Valve Regurg., ADHD, Allergies	~ ()~~~In patient		1						1	Cardiovascular disorder; Hyperkinesia; Rash; Vasculitis	FLU3~CONNAUGHT LABORATORIES~60144AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0131772	12/29/1999	UT	61.0	61		M	11/04/1999	5 days after injection, I had severe light headedness & balance problems, lasting 6 hrs on 10/19. On 10/20, had light diarrhea. On 10/22, had servere gas & diarrhea; took Lomotal to stop it. On 10/23, got up, felt fine, no problems. Follow-up indicates pt had the flu for 3 weeks over Christmas and New Years. Now, still not over it, starting with sore throat and aches in my joints about 4/11/00.				Y					N	10/13/1999	10/19/1999	6		OTH	PVT		NONE	High BP			1						1	Arthralgia; Coordination abnormal; Diarrhoea; Dizziness; Flatulence; Influenza; Pharyngitis	FLU3~PARKDALE PHARMACEUTICALS~03279P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0131773	12/29/1999	WI	61.0	61		F	11/03/1999	Hives for 1 week.				Y					Y	10/13/1999	10/15/1999	2	2 doctor visits	OTH	PVT	Accupril	NONE	NONE	~ ()~~~In patient		1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0131774	12/29/1999	WA				M	11/05/1999	3-4 days later, got URI-like symptoms. No local reaction, rash, wheezing, etc. URI/cough.				Y					Y	10/20/1999	11/05/1999	16		PVT	OTH			HTN, CAD	~ ()~~~In patient		1						1	Coronary artery disease; Cough; Hypertension; Influenza; Pharyngitis	FLU3~PFIZER\WYETH~4998230~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0131776	12/29/1999	SC	14.0	13		M	11/17/1999	6 cm redness & induration of site of Pneumovax. Fever 102-103, evening after the shot and the next day. Nausea & vomiting for 2 days, general malaise. Received IV fluids and Phenergan for nausea and improved.				Y					Y	11/15/1999	11/15/1999	0	CBC, Chem 7-normal	MIL	MIL	Flovent, Serevent, Zyrtec	Diarrhea	Asthma, Allergic Rhinitis	~ ()~~~In patient		1						1	Diarrhoea; Injection site hypersensitivity; Injection site mass; Malaise; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0168A~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466786~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0131781	12/29/1999	OH	47.0			F	11/15/1999	C/o chest pain radiating to L/arm, SOB, sweating.				Y					U				NONE	OTH	PVT		NONE	States had MI before	~ ()~~~In patient		1						1	Chest pain; Dyspnoea; Hyperhidrosis; Pain	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0131783	12/29/1999	MD	68.0	68		F	11/16/1999	Adverse reaction to shot was swelling in face, rash on face, neck, & arms and severe itching and redness. Later, rash also developed on body.				Y						10/25/1999	10/26/1999	1		OTH	OTH				~ ()~~~In patient		1						1	Face oedema; Pruritus; Rash; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0131787	12/29/1999	MI	29.0	29		F	11/08/1999	Itching and rash-like all around injection site (white bumps w/red rash). Noticed 1-2 days after shot. Went to DR, he said looked like she was allergic to something in shot. Called a few days later, and patient was better.				Y					Y	10/07/1999	10/08/1999	1		OTH	OTH	Vitamin B-12			~ ()~~~In patient		1						1	Hypersensitivity; Injection site hypersensitivity; Pruritus; Rash maculo-papular	FLU3~PARKDALE PHARMACEUTICALS~02089P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0131790	12/29/1999	NJ	1.6	1	.6	M	11/17/1999	Fever. irritability, malaise and cough beginning within 8 hours of getting 1st flu vax.				Y					Y	11/15/1999	11/15/1999	0	NONE	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Agitation; Cough; Malaise; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~P03179P~1~IM~LL~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0131791	12/29/1999	NC	39.0	39		F	11/29/1999	Swelling of nodes under left arm, soreness under arm spreading to breast, low grade fever, scratchy throat, muscle aches and sinus symptons.				Y					Y	11/12/1999	11/13/1999	1		MIL	PVT	NONE		Environmental allergies	~ ()~~~In patient		1						1	Breast pain; Lymphadenopathy; Myalgia; Pharyngitis; Pyrexia; Sinusitis	FLU3~PFIZER\WYETH~4998249~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0131792	12/29/1999	CA	74.0	73		M	11/20/1999	Aches all over, achey joints onset. Per HCP follow up report-I assume I would have included the numbers you are looking for at the time of the report if they were available. 8 months later I don't even remember filling out the form and could not get the info from chart. Patient probably got the vaccine at a flu shot clinic.				Y					U	11/09/1999	11/10/1999	1	CBC, Sed Rate, Chem 20	UNK	UNK	Celebrex, Flexeril	NONE				1						1	Arthralgia; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0131793	12/29/1999	IA	28.0	28		F	11/23/1999	Pt. reported 11/23/99 at 14:00 w/swollen & warm right deltoid with pain/aching rt. arm, shoulder & clavical. Also, c/o numbness in rt. hand. Pt. states unable to move arm without increased pain. Dr. told pt. to take Tylenol & ice on area.				Y					U	11/22/1999	11/22/1999	0		PUB	UNK		NONE	Mitral Valve Prolapse, NKA	~ ()~~~In patient		1						1	Hypokinesia; Injection site oedema; Myalgia; Pain; Paraesthesia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0145DA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0870H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0131797	12/29/1999	CO	41.0	41		F	11/12/1999	On 10/9/99, that afternoon, area itched. Wednesday, it itched & Thursday, it hurt. Area 2-3 around where shot was given; was red, swollen & sore. Sent to MD. MD stated that it was a reaction from Thermerosol.				Y					U	10/09/1999	10/09/1999	0		OTH	PUB		Was on antibiotic for a cyst		~ ()~~~In patient		1						1	Cyst; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus	FLU3~PARKDALE PHARMACEUTICALS~00399P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0131801	12/29/1999	WI	42.0	42		F	11/12/1999	Throat swelling, itchy eyes.				Y					Y	11/09/1999	11/09/1999	0	S : S only	PUB	OTH	Servent, zyrtec, flovent, singular, ibuprofen, amitriptyline		Allergies to trees, grasses, dust, mites, dogs, cats, - asthma, fibromyalgia	Patient became ill following a HepB vaccine dose 1  in series, no date provided.~ ()~~~In patient		1						1	Laryngospasm; Pruritus	FLU3~PFIZER\WYETH~4998214~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0131803	12/29/1999	NH	24.0	24		M	11/08/1999	11/4/99 - Arm painful, some swelling, warm.  11/5/99 - elevated pain, chest tight.  11/6/99 - fever, chest tight, local inflammation went to ER, on antiobiotic for cellulitis.  11/8/99 - no fever, inflammation decreased, dizzy, headache.				Y					U	11/04/1999	11/04/1999	0	CBC, lytes, BVN, CV, LFT's pending	UNK	UNK	NONE	NONE	NONE			1						1	Chest pain; Dizziness; Headache; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~00199P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~463716~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0131811	12/29/1999	NY	14.0	14		F	11/19/1999	Mother states pt had a temperature of 105.  Vaccine administered the previous day.  Pt taken to ER that evening.  Mother states pt had similar reaction to hep b vaccine.				Y					Y	11/17/1999	11/18/1999	1		PVT	PVT	Zyrtec, Anaprox	Allergies, dysentary, snoring	Being worked up for fragile X testing, Mental Retardation	~ ()~~~In patient		1						1	Gastrointestinal disorder; Mental retardation severity unspecified; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0171AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0131814	12/29/1999	KS	48.0	48		F	11/12/1999	Received vaccination and it began to swell from inject site to elbow.  Received tylenol and cold pack. Became nauseated later.  Next day warm compress applied.  Limited motion and soreness remains today.				Y					N	10/20/1999	10/20/1999	0		UNK	UNK	Orenogase	NONE	NONE	~ ()~~~In patient		1						1	Hypokinesia; Injection site oedema; Myalgia; Nausea	FLU3~CONNAUGHT LABORATORIES~U0095AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0131819	12/29/1999	CA	54.0	54		F	11/01/1999	Within 2 hrs of the vaccine, pt noted throat tightness, shaky feeling; eyes red. Seen in ER, given racemic epinephrine; Claritin Dx2d, Benadryl 25mg IVP.				Y					Y	09/23/1999	09/23/1999	0		PUB	PVT	UNK	NONE	NONE	~ ()~~~In patient		1						1	Conjunctivitis; Laryngospasm; Nervousness	FLU3~PFIZER\WYETH~4998211~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0131820	12/29/1999	OH	64.0	64		F	10/25/1999	Am after shot, pt passed out at 6:00am. Noticed soreness & stiffness of neck, shoulder, back & R/arm, also, dizziness. Friday am, woke up & noticed R/arm swelling, progressing to below elbow & half of forearm. R/arm was red, hot to touch &				Y					Y	10/20/1999	10/21/1999	1	NONE	UNK	UNK	Premarin, Medroxyprogesterone, Baby Aspirin	NONE	Hayfever (ragweed dust)		0H99092	1						1	Dizziness; Hypertonia; Injection site hypersensitivity; Injection site oedema; Neck pain; Nuchal rigidity; Syncope; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0144AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1585H~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0131821	12/29/1999	PA	49.0	49		F	11/03/1999	Developed severe warmth & flushing of her face & neck, 20-30 mins after Flu vaccine. Resolved without treatment in about 15-20 mins.				Y					Y	10/25/1999	10/25/1999	0	NONE	PVT	PVT	Allegra-D, Premarin, Zoloft	NONE	DJD, Enviromental allergies	~ ()~~~In patient		1						1	Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0132AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0131822	12/29/1999	TN	39.0	39		F	10/28/1999	9:15am, pt felt weak, face red, B/P 170/110, Pulse 80. Pt unreactive to voice stimulation for 1-2 mins low blood sugars. 9:25, B/P 160/96, Pulse 82. 9:40, B/P 120/80, Pulse 80-regular. Taken to DR as precaution. Tx'd for hypoglycemia.				Y					Y	10/28/1999	10/28/1999	0		OTH	PVT		Hypoglycemia	Hypoglycemia	~ ()~~~In patient		1						1	Asthenia; Condition aggravated; Hypertension; Hypoglycaemia; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0131823	12/29/1999	CA	46.0	46		M	10/22/1999	11/2, temp 101, severe rash at injection site (pustules formed later). Rash persisted for several mos then spread to my neck, then to anterior of both thighs. I have rcv'd 10 mos of treatment for staph aureus. Tx has been only partially				Y					N	10/31/1998	11/02/1998	2		PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Infection; Injection site hypersensitivity; Pyrexia; Rash pustular	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0131826	12/29/1999	KY	56.0			F	11/18/1999	24 hrs after shot administered, increased pruritic at site of injection. No fever, n/v/d, sob. 2 1/2 erythema.									Y	11/09/1999	11/10/1999	1		MIL	MIL	Zocar, ASA	NONE	Allergy Macrodantin	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0169HA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131830	12/29/1999	OH	22.0	22		F	11/04/1999	Pt developed fever 101 degrees, dizziness, flush, nausea and diarrhea.									Y	10/28/1999	10/30/1999	2		OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Diarrhoea; Dizziness; Nausea; Pyrexia; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02189P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0131835	12/29/1999	MN	15.0	15		M	11/04/1999	Patient developed pneumonia.									U	10/20/1999	11/03/1999	14	Xray, CBC	PVT	PVT	Mysoline, Albuteral, Depakote	NONE	C.P. developmental delay	~ ()~~~In patient		1						1	Infection; Mental retardation severity unspecified; Pneumonia	FLU3~CONNAUGHT LABORATORIES~U0159AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~455938~UNK~IM~RL~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0131839	12/29/1999	WI	61.0	61		F	10/25/1999	Pt developed swelling L/stemoclavicular area, had discomfort and pruritis associated with the swelling.  Had discomfort and pruritis at injection site. RN reported significant swelling, no redness or temp increase.									Y	10/20/1999	10/21/1999	1	NONE	PUB	PVT	Proxican, HCTZ	NONE	Chronic back pain, Hypertenson	~ ()~~~In patient		1						1	Back pain; Hypertension; Injection site hypersensitivity; Injection site pain; Lymphadenopathy; Oedema; Pain; Pruritus	FLU3~PARKDALE PHARMACEUTICALS~02189F~4~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0131841	12/29/1999	MA	64.0	64		F	10/30/1999	Violently ill, bedridden for 7 days. Still have coughing, began with sore throat, aching in body, ear ache, weakness and poor appetite.									Y	10/20/1999	10/21/1999	1		PUB	OTH		NONE	Allergies to dust, asperin, narcotics	~ ()~~~In patient		1						1	Anorexia; Asthenia; Cough; Ear pain; Hypokinesia; Malaise; Myalgia; Pharyngitis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0131844	12/29/1999	MI	68.0	68		M	11/01/1999	Pt reported developing welts (6 hours after receiving flu vax) on lower forearm of same arm vax was administered.  3-4 area of reddened welts.									U	10/28/1999	10/28/1999	0		PUB	PUB				~ ()~~~In patient		1						1	Injection site hypersensitivity; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0131850	12/29/1999	FL	32.0	32		F	10/28/1999	Symptoms began with all over achiness and tired, pain at inject site.  Next day, sluggish with headache and then a fever, nausea, vomitting, diarrhea, night sweats and swollen glands in the neck and tonsils.  Virus two later.										10/26/1999	10/26/1999	0		PVT	PVT	Prenatal vitamins, (not pregnant)	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Diarrhoea; Headache; Hyperhidrosis; Infection; Injection site pain; Lymphadenopathy; Myalgia; Pharyngitis; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~4998252~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131851	12/29/1999	VA	47.0	47		F	10/26/1999	Woke 10/23/99 with fever of 103, headache, body aches, dizziness, symptoms lasted until 10/25/99.									Y	10/22/1999	10/23/1999	1	NONE	UNK	UNK	Prinivil		hypertension- controlled	Patient had same adverse events with flu shots prior to current vaccination.~ ()~~~In patient		1						1	Dizziness; Headache; Hypertension; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4998228~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131852	12/29/1999	MA	42.0	41		F	11/01/1999	Within 36 hours of vaccine, developed sore throat and upper respiratory infection that persisted for 10 days - 2 weeks.									Y	10/15/1999	10/17/1999	2		UNK	UNK		NONE	Fibromyalgia, multiple chemical sensitivity syndrome			1						1	Myalgia; Pharyngitis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0131853	12/29/1999	SD	21.0	21		U	10/22/1999	Dime sized, raised red rash, volar aspect left arm, scattered raised, red pinpoint rash, volar aspect right forearm.  Complained of tightness in chest briefly, resolved approximately 20 minutes after benadryl given.									Y	10/22/1999	10/22/1999	0		OTH	PUB				~ ()~~~In patient		1						1	Chest pain; Rash maculo-papular	FLU3~PFIZER\WYETH~4998238~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131854	12/29/1999	CA	46.0	46		F	11/01/1999	Arm swollen and sensitive to touch.  Within two hours developed a very rapid heart beat (160 resting).  Pt took an additional Inderal tablet (10 mg), to control rapid beat. Fever and muscle aches for one day, arm sore during this time.									Y	10/18/1999	10/18/1999	0		PVT	OTH	Inderal, Bayer Aspirin	NONE	Allergy to milk and wheat	~ ()~~~In patient		1						1	Cardiovascular disorder; Myalgia; Oedema peripheral; Pain; Pyrexia; Tachycardia	FLUX~UNKNOWN MANUFACTURER~U0150AA~7+~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0131857	12/29/1999	MN	38.0	38		F	11/04/1999	Large lump on R/arm for 2 days following injection. 2 days later large lump developed in r/arm pit, lt breast, joint pain, temp of 101-102 for 4 days. Lump in arm returned. UA showed protein, bilirubin and WBC's.									Y	10/20/1999	10/23/1999	3	NONE	UNK	UNK		Bronchitis (3 wks prior)	NONE	~ ()~~~In patient		1						1	Arthralgia; Hyperbilirubinaemia; Injection site mass; Laboratory test abnormal; Leukocytosis; Lymphadenopathy; Pyrexia	FLUX~UNKNOWN MANUFACTURER~4998228~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1611H~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0131858	12/29/1999	CA	55.0	55		M	11/09/1999	Warm injection spot, hard spot, no pain.									Y	11/03/1999	11/04/1999	1		UNK	UNK		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0131859	12/29/1999	CA	47.0	47		M	10/07/1999	Within 5 minutes after injection, patient stated he felt dizzy.									Y	10/07/1999	10/07/1999	0		OTH	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Dizziness	FLU3~PFIZER\WYETH~4998233~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131860	12/29/1999	NE	31.0	31		F	10/27/1999	Localized, red, swollen, area, hot and sore for a week. No meds, symptoms went away in a week.									Y	10/12/1999	10/12/1999	0		OTH	OTH				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~60118AA~7+~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131862	12/29/1999	AR				M	11/10/1999	11-6-99 ---11/7/99, pt developed urticaria, induration and erythema.									Y	11/04/1999	11/06/1999	2		OTH	PUB	Atenolol, provera, procardia, premarin, asa, oscal			~ ()~~~In patient		1						1	Rash; Skin nodule; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466444~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0131863	12/29/1999	AR	88.0	88		F	11/10/1999	Urticaria, induration erythema, lasting from 11/6/99 through 11/7/99.									Y	11/04/1999	11/06/1999	2		OTH	PUB	Axid, captopril, lasix, k-dur, levoxyl			~ ()~~~In patient		1						1	Rash; Skin nodule; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466444~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0131864	12/29/1999	AR	78.0	78		F	11/10/1999	Redness @ injection site 8-10cm, fever, erythema, urticaria and induration.  Treated with benadryl and tylenol.  Duration period was 11/6/99 - 11/9/99.									Y	11/04/1999	11/05/1999	1		OTH	PUB	Estrogen, progestrone, paxil, metoprolol, chlonagspam			~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Pyrexia; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466444~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0131865	12/29/1999	AR	88.0	88		F	11/10/1999	Urticaria, induration, erythema, treated with benadryl.									Y	11/04/1999	11/06/1999	2		OTH	PUB	meclofenamate, megace, thipaid, fosmax			~ ()~~~In patient		1						1	Rash; Skin nodule; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466444~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0131870	12/29/1999	MD	57.0	56		F	11/10/1999	Pruritus, 8 discrete scabbed, excoriated lesions.  3@ site or near site of injection in R/Deltoid.  5 on upper back, no urticaris at time of examination by physician.									Y	11/03/1999	11/05/1999	2		OTH	PVT	Synthroid, provera, premarin	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0067AA~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131872	12/29/1999	MD	23.0	23		F	11/12/1999	Pt received flue vaccind at 4pm, at 4:10 developed chest pain/pressure, dizziness, nausea.  Was flushed, no SOB, given epinephrine, EMS notified, pt refused transport/ symptoms resolved. Advised to see MD. P 80, BP 150/98.									Y	11/05/1999	11/05/1999	0		OTH	PVT		NONE	NONE	~ ()~~~In patient		1						1	Chest pain; Dizziness; Hypertension; Nausea; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~V0158AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131875	12/29/1999	NH	41.0	41		F	11/11/1999	Within one hour of vaccine pt complained of itchy little red spots.  Approx. 3 1/2 hrs after vaccine, pt developed increase of itching, hives on face, neck, torso and arms.  Treated with Benadryl.									Y	10/20/1999	10/20/1999	0		PVT	PVT		NONE		~ ()~~~In patient		1						1	Pruritus; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0130AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131876	12/29/1999	NY	58.0	58		F	11/22/1999	Red - itchy - lump on 11/16/99.									Y	11/15/1999	11/16/1999	1		OTH	OTH				~ ()~~~In patient		1						1	Pruritus; Skin nodule; Vasodilatation	FLU3~PFIZER\WYETH~4998245~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131879	12/29/1999	NH	42.0	42		M	11/11/1999	1 hour after receiving vaccine both hands began to swell.  Swelling lasted for +36 hours with no other symptoms.  No medical Rx required.  No medications taken.									Y	10/28/1999	10/28/1999	0	NONE	PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~U0130AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131880	12/29/1999	NY	4.0	4		F	11/22/1999	Large area of induration with erythema, covering most of upper arm.  Had previous reaction fall 98, treated for cellulitis with Keflex.									Y	11/17/1999	11/17/1999	0		PVT	UNK		NONE	Asthma	Pt has had previous reaction to flu vaccine at 3 years of age.~ ()~~~In patient		1						1	Asthma; Cellulitis; Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131883	12/29/1999	KS	45.0	45		F	10/29/1999	Headache, nausea, decreased energy, hot to touch at injection site, red and puffy 3x2 area.									U	10/26/1999	10/26/1999	0	NONE	PUB	PVT	Inderal, Haldol, Wellbutrin, Prozac, Trazaclone	NONE	Allergy to Tegratal and Diphtheria Toxin shots	Pt had adverse event to Diphtheria shot in 1978.~ ()~~~In patient		1						1	Asthenia; Headache; Injection site hypersensitivity; Injection site oedema; Nausea; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0132AA~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131885	12/29/1999	MI	65.0	65		F	10/26/1999	Heaviness in chest for 6 hours, swollen left arm -  pneumonia shot, soreness - 4 days, rash - 2nd day very itchy.									Y	10/06/1999	10/06/1999	0		OTH	OTH	Premarin, hydrox, progesterone, claratin	NONE	High Blood Pressure	~ ()~~~In patient		1						1	Chest pain; Hypertension; Injection site oedema; Injection site pain; Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~IM~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0131888	12/29/1999	GA	44.0	44		M	11/01/1999	Pt developed stiffness and soreness in left arm and left side of neck.  Numbness down to left hand into fingers.  Pt also experienced a headache.										10/29/1999				PUB	PVT				~ ()~~~In patient		1						1	Headache; Hypertonia; Neck pain; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~U0131AA~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131890	12/29/1999	FL	22.0			M	11/01/1999	Superficial cellulitis, treatment / culture and antibiotics.									Y	10/27/1999	10/30/1999	3		MIL	MIL		NONE	PNC amoxicillin	~ ()~~~In patient		1						1	Cellulitis	FLU3~PFIZER\WYETH~49987234~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131892	12/29/1999	NC	40.0	40		F	10/27/1999	Pt came to office with complaints of lightheadness and different feeling.  No rash, no shortness of breath.  BP 110/70, R 20, HR 80.									Y	10/27/1999	10/27/1999	0	NONE	OTH	OTH		NONE		~ ()~~~In patient		1						1	Dizziness; Hypotension; Malaise	FLU3~CONNAUGHT LABORATORIES~U0158AA~1~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131893	12/29/1999	MN	52.0	51		F	10/28/1999	Low grade fever, malaise, dizziness, flushing, body aches.									N	10/25/1999	10/26/1999	1	NL, CBC, +UA - not related to vaccine	PVT	OTH		Possible low grade UTI		~ ()~~~In patient		1						1	Dizziness; Malaise; Myalgia; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0095AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131896	12/29/1999	MD	60.0	60		F	10/28/1999	Large 2x3 irregular circle at site of injection, bright red, swollen, feverish.  By 6/27/99 pt felt extreme fatigue bordering on exhaustion.									U	10/26/1999	10/26/1999	0		PUB	UNK		Thyroid disease	NONE	Pt has had a reaction previously to unknown vaccine.~ ()~~~In patient		1						1	Asthenia; Injection site hypersensitivity; Injection site oedema; Thyroid disorder; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0131899	12/29/1999	PA	57.0	57		M	11/03/1999	Pneumococcal vaccine 10/27/99, on 10/28/99, pt's arm was red, swollen from shoulder to elbow, body aches, lethargy.									Y	10/27/1999	10/28/1999	1		PVT	PVT				~ ()~~~In patient		1						1	Acne; Diabetes mellitus; Injection site hypersensitivity; Injection site oedema; Myalgia; Somnolence	FLU3~CONNAUGHT LABORATORIES~U0067AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~459042~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0131900	12/29/1999	MO	34.0	34		F	10/28/1999	10/28/99 - phone call to pt for follow up.  Approximately 4 hours post vax, pt began feeling achy and running a low temp.  Family physician authorized ibuprofen.									U	10/26/1999	10/26/1999	0		OTH	OTH	celexa, premarin, thyroid	NONE	Allergy to anesthesia	~ ()~~~In patient		1						1	Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0158AA~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131901	12/29/1999	MN	14.0	14		F	11/01/1999	Within 5 mins of receiving vaccine, pt became pale, forehead was clammy.Pt stated she did not feel well.PHN had pt lower head.  BP 110/80, P 60, Mother mentioned pt had eated poorly at school. Within 2 minutes pt felt better but still pale.									U	10/28/1999	10/28/1999	0		PUB	PUB		NONE		~ ()~~~In patient	MN99021	1						1	Hyperhidrosis; Malaise; Pallor	FLU3~PFIZER\WYETH~4998285~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131902	12/29/1999	NE	50.0	50		F	11/01/1999	Body aches and fever 2 hours after the shot.									Y	10/29/1999	10/29/1999	0		PUB	OTH		NONE		~ ()~~~In patient		1						1	Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0129AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131903	12/29/1999	WI	44.0	44		M	11/04/1999	Pt reported having chills, diaphoresis, weakness, malaise with 1-2 hours post vax.  Felt he probably had a fever but took acetaminophen throughout the day to reduce discomfort.  Sx's persisted for 2 days.									Y	10/29/1999	10/29/1999	0		PUB	PUB					WI09045	1						1	Asthenia; Hyperhidrosis; Malaise; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~021898~7+~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0131904	12/29/1999	TX	57.0	57		F	10/25/1999	Hematoma following flu vaccine; induration and erythema also; c/o itch treated with heat packs.									Y	10/22/1999	10/22/1999	0		OTH	OTH	Claritin, premarin		Pollen allergies (environmental), molds	~ ()~~~In patient		1						1	Injection site haemorrhage; Injection site hypersensitivity; Injection site mass; Pruritus	FLU3~PFIZER\WYETH~4998230~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131905	12/29/1999	WA	22.0	22		M	11/05/1999	A weak febrile reaction post influenza vaccination, resolved in 6 hours.									Y	10/21/1999	10/22/1999	1		PVT	PVT	aneral, prozac, metformin	NONE	NONE	~ ()~~~In patient		1						1	Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0134AA~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131906	12/29/1999	NE	32.0	32		F	10/28/1999	Watery eyes, runny nose, itchy skin, shortness of breath, cough, chest tightness.  2 hours post flu shot.									Y	10/13/1999	10/13/1999	0		PUB	OTH	BCP	NONE	Allergies to mold and dustmites	~ ()~~~In patient		1						1	Chest pain; Cough; Dyspnoea; Lacrimal disorder; Pruritus; Rhinitis; Chest pain; Cough; Dyspnoea; Lacrimal disorder; Pruritus; Rhinitis	FLU3~CONNAUGHT LABORATORIES~U0129AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0129AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0131906	12/29/1999	NE	32.0	32		F	10/28/1999	Watery eyes, runny nose, itchy skin, SOB, cough, chest tightness 2 hrs after shot.									Y	10/13/1999	10/13/1999	0		PUB	OTH	BCP	NONE	Allergies to mold, dust mites, etc.	~ ()~~~In patient		1						2	Chest pain; Cough; Dyspnoea; Lacrimal disorder; Pruritus; Rhinitis; Chest pain; Cough; Dyspnoea; Lacrimal disorder; Pruritus; Rhinitis	FLU3~CONNAUGHT LABORATORIES~U0129AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0129AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0131907	12/29/1999	CA	77.0	77		F	11/08/1999	Vomiting, weakness, fever and couldn't ear solid food for a week.									Y	10/17/1999	10/18/1999	1		OTH	OTH	Vasotec 20mg	NONE	High blood pressure	~ ()~~~In patient		1						1	Anorexia; Asthenia; Hypertension; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0131908	12/29/1999	CA	42.0	42		M	11/06/1999	10/24/99 to 10/28/99, felt tired, with hives on upper chest, deltoids, front of shins & behind knees; itchy w/flaking skin. Symptoms started to go away about 11/1/99; used vitiman-E oil & lotion on effected areas. Also, had pain in deltoids									Y	10/20/1999	10/24/1999	4	NONE	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Dermatitis exfoliative; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~IM~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0131909	12/29/1999	VA	46.0	46		F	10/28/1999	Developed significant pain within 24 to 48 hrs. of vaccine administration. Developed paresthesias, weakness, loss of function of 1st & 2nd fingers.									N	10/04/1999	10/05/1999	1	Pending	PVT	PVT	Zyrtec, Flonase, Tilade Ilovent	NONE	Asthma, MVP, Rhinitis, Iodine (rash)	~ ()~~~In patient		1						1	Asthenia; Asthma; Hypokinesia; Pain; Paraesthesia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~096960~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~463021~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0131910	12/29/1999	VA	52.0	52		F	11/02/1999	Very itchy, rash over entire body, starting the afternoon after getting flu shot. Lasted more than 1 week.									Y	10/25/1999	10/25/1999	0		OTH	PVT		NONE		~ ()~~~In patient		1						1	Pruritus; Rash	FLU3~PARKDALE PHARMACEUTICALS~02189P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0131911	12/29/1999	CT	38.0	38		F	11/08/1999	Pt. had local swelling, erythema & pain left deltoid, measuring, approx. 4x4, along w/headache & mild nausea/chills, the day after vax. Had fever to 103 over next 2 days w/erythema extending over entire upper arm. Tx'd w/antibiotics,rest.									Y	11/04/1999	11/04/1999	0		PVT	PVT	BCP only	NONE	NONE	~ ()~~~In patient		1						1	Chills; Headache; Injection site hypersensitivity; Injection site oedema; Injection site pain; Nausea; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~U0152AB~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0043J~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0131915	12/29/1999	TX	47.0	47		F	10/26/1999	On waking, 10/23/99, had joint pain, muscle weakening, aching and profound malaise that caused her to remain in bed most of the morning, mildly relieved with Tylenol. By afternoon, had chills & cramping of muscles with any movement. Took a									Y	10/22/1999	10/23/1999	1		PVT	PVT	Allergy shots	NONE	Allergies to cedar and cats	~ ()~~~In patient		1						1	Arthralgia; Chills; Hypertonia; Malaise; Myalgia	FLU3~PFIZER\WYETH~4998251~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131916	12/29/1999	MN	27.0	27		F	11/15/1999	Pt. got an immediate red rash around the injection site (approx. 3 in diameter). Pt. felt faint for about 5 min. but this passed. Arm sore & ached for 48 hrs. Rash resolved within 24 hrs. No swelling.									Y	10/28/1999	10/28/1999	0	NONE	PVT	PVT			Allergic to Haldol	~ ()~~~In patient		1						1	Dizziness; Injection site hypersensitivity; Myalgia; Pain	FLU3~PFIZER\WYETH~4998228~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131919	12/29/1999	FL	37.0	37		F	11/19/1999	Dizziness, Vertigo									U	10/22/1999	10/29/1999	7		PVT	OTH	Allegra, Minocin, Flonase	NONE	Allergies	~ ()~~~In patient		1						1	Dizziness; Vertigo	FLU3~CONNAUGHT LABORATORIES~U0158AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131920	12/29/1999	MD	53.0	53		F	11/23/1999	11/12, sore arm. 11/15, aching joints, tiredness & eyes hurt. No knowledge of temp. 11/16, felt better during the am, but sx's reoccurred in the evening, to a lesser degree. Aching joints, hips, wrist, knees-more at night. 11/21,felt normal									Y	11/12/1999	11/15/1999	3	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Arthralgia; Asthenia; Eye pain; Pain	FLU3~PARKDALE PHARMACEUTICALS~02289P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0131921	12/29/1999	AZ	40.0	40		F	11/22/1999	L/deltoid, localized induration/ecchymosis/systemic viremic sx's, including neck stiffness. By 3rd day, sx's resolving.									Y	11/19/1999	11/19/1999	0	NONE	PUB	PVT	NONE	NONE		~ ()~~~In patient		1						1	Ecchymosis; Injection site hypersensitivity; Injection site mass; Nuchal rigidity	FLU3~CONNAUGHT LABORATORIES~U0130AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131925	12/29/1999	NM	46.0	46		F	11/02/1999	3:00 pm, pt felt extremely fatigued; 6:00 pm, started coughing & at 6:30 pm, more frequently coughing & general malaise. Went to bed 7:00 pm, eyes very itchy, red & swollen. 8:00 pm, eye sockets very tender to touch & eyes still swelling.									Y	10/12/1999	10/12/1999	0	NONE	OTH	OTH	Motrin 600md BID x 1 week	R/side pain related to possible rib fracture	Mild allergies to grass, dust x 30 yrs, but only take med Claritin or Sudafed 1-2x yr	Pt developed Herpes Simplex at age 38, after 2nd or 3rd dose of HEP-B vax.~ ()~~~In patient		1						1	Asthenia; Conjunctivitis; Cough; Eye pain; Face oedema; Malaise; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0127AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131926	12/29/1999	IL	63.0	63		M	11/16/1999	Rifle shooting 11/6/99 with strap for rifle secured around left arm. On 11/7/99, in pm, L/upper arm sore. On 11/8/99 pm, slight fever & generalized discomfort. On 11/9/99,every bone in my body hurt. Used Advil & heating pad. 11/10/99 RTW.									Y	11/03/1999	11/07/1999	4	NONE	OTH	PVT	Lipitor, Acebutolol, ASA, Garlic, Caffeine	NONE	NONE	~ ()~~~In patient		1						1	Bone pain; Injection site pain; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0155AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131927	12/29/1999	AR	81.0	80		F	11/10/1999	Urticaria, induration and erythema. Benadryl 25mg po q 4 prn.									Y	11/04/1999	11/06/1999	2		OTH	OTH				~ ()~~~In patient		1						1	Rash; Skin nodule; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466444~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0131929	12/29/1999	WI	49.0	49		M	11/15/1999	On 10/30/99, pt broke out in hives & rash all over body. Took Benadryl and improved by next day. On 11/2/99, pt at ball game, & eyes started to swell. Started Benadryl again & improved. No further episodes.									Y	10/29/1999	10/30/1999	1	NONE	PVT	PVT	Prinivil, 10mg	NONE	High blood pressure	~ ()~~~In patient		1						1	Face oedema; Hypertension; Rash; Urticaria	FLU3~PFIZER\WYETH~4998229~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~458745~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0131934	12/29/1999	NY	1.5	1	.5	M	11/15/1999	Hives on chin approximately 1 hr after injections were given. Fever developed within 24 hrs.									Y	11/12/1999	11/12/1999	0		PVT	PVT	NONE	NONE	Eczema	~ ()~~~In patient		1						1	Eczema; Pyrexia; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0205AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1304J~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0131936	12/29/1999	CA	28.0	28		F	10/26/1999	Localized redness & induration. No fever. Frontal headache. Onset one hr after injection in left deltoid. (examined 1 day later). Treated with ibuprofen and ice compresses.									U	10/25/1999	10/25/1999	0		PUB	OTH	Claritin, Aerobid, Albuterol, APAP, Vancrease, Accolate	Gyn exam	NKA/Active Hep-B 1995, Decreased abd pain, GERD, Asthma	~ ()~~~In patient		1						1	Asthma; Gastrointestinal disorder; Headache; Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4998221~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~459041~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0131937	12/29/1999	NE	49.0			F	10/19/1999	Couldn't get out of bed 10/16/99, severe dizziness, room spinning, felt like motion sickness; better if I was horizontal. No fever, achiness or headache. Dizziness w/quick movement on 10/17/99, but less severe than on 10/16/99.									Y		10/16/1999			PVT	PVT				~ ()~~~In patient		1						1	Dizziness; Vertigo	FLU3~CONNAUGHT LABORATORIES~U0129AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131940	12/29/1999	FL	60.0	60		F	11/02/1999	Headache, extreme body ache all over, no energy and loss of appetite for 3-5 days.									Y	10/07/1999	10/14/1999	7		OTH	PVT		NONE		~ ()~~~In patient		1						1	Anorexia; Asthenia; Headache; Myalgia	FLU3~CONNAUGHT LABORATORIES~V0131AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131941	12/29/1999	FL	68.0	68		M		Headache, fever, chills, extremely sore joints, all over ache and listliss, ranged from 3 days to about 5 days before all gone.									Y	10/07/1999	10/14/1999	7		OTH	OTH		NONE		~ ()~~~In patient		1						1	Arthralgia; Headache; Myalgia; Pyrexia; Somnolence	FLU3~CONNAUGHT LABORATORIES~V0131AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131942	12/29/1999	OH	76.0	76		F	11/02/1999	Burning hot tongue & lips, 5 hrs after Flu shot. No problem breathing, no swelling. She took Benadryl. Today, lips & tongue swollen & looks inflammed under tongue a little & reports there was some swelling initial day.									Y	11/01/1999	11/01/1999	0		PVT	PVT			Allergy Pcn, Macrotantin, Sulfa, & Mycin	~ ()~~~In patient		1						1	Face oedema; Pain; Tongue disorder; Tongue oedema	FLU3~CONNAUGHT LABORATORIES~U0063AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131943	12/29/1999	LA	83.0	83		F	11/02/1999	Same day, felt achy, cold, headache and  could not seem to get warm. Just wanted to wrap up and sleep, was not very energetic, felt lousy and sore. After 2nd day, back to normal. (I am fine now)									Y	10/25/1999	10/25/1999	0		PUB	OTH				~ ()~~~In patient		1						1	Asthenia; Chills; Headache; Malaise; Myalgia; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~IM~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0131944	12/29/1999	MO	39.0	39		F		Experienced red face, fever of 102.4 & swelling of glands. Reported no SOB. Called family provider & was prescribed Benadryl. Symptoms resolved in 2-3 days.									Y	10/12/1999	10/17/1999	5	NONE	PUB	OTH	NONE			~ ()~~~In patient		1						1	Lymphadenopathy; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4998217~4~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131945	12/29/1999	AR	13.0	13		M	11/11/1999	Pt woke up with 102 temp and felt like he was trying to hyperventilate. Felt weak.									N	11/10/1999	11/11/1999	1		PVT	PVT		Asthma	Asthma, Allergies	~ ()~~~In patient		1						1	Asthenia; Asthma; Hyperventilation; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0103AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0043J~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0131946	12/29/1999	MN	47.0	47		F	10/25/1999	Phone call from pt at 13:24; had Flu shot in am. Stated red raised rash on legs, arms & itching, started 1 hr ago. No SOB, no throat swelling or difficulty breathing. Tx'd w/Benadryl 50mg every 4 to 6 hrs.									Y	10/22/1999	10/22/1999	0	NONE	PVT	OTH	UNK	UNK	Allergy to Sulfa	~ ()~~~In patient		1						1	Pruritus; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~U0129AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131947	12/29/1999	IA	65.0			M	11/01/1999	Pt stopped at clinic on 10/25/99, so a nurse could look at his arm. He was referred on to Dr who examined his injection site.									Y	10/23/1999	10/23/1999	0		PUB	OTH				~ ()~~~In patient		1						1	Unevaluable event	FLU3~CONNAUGHT LABORATORIES~U0145CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0870H~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0131948	12/29/1999	CA	64.0	64		F	11/01/1999	At site of Pneumonia shot, hurt on administration. Started to be inflammed until about 6 up arm & almost encircling arm. Arm very painful to move last night. Took Tylenol daytime for 3 days. After 1 wk, redness gone, but painful to touch.									Y	10/17/1999	10/17/1999	0		OTH	OTH	Estropipate, Synthroid, Calcium, Medroxyprogesterone, Vit E & B-6			Had sore arm after Flu shot at age 63.~ ()~~~In patient		1						1	Injection site inflammation; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0131952	12/29/1999	CA	47.0	47		F	11/01/1999	Morning following vax, numbness in R hand. Pinky & ring fingers also numb and R side of R hand. Symptoms persisted for 72 hrs.									Y	10/07/1999	10/08/1999	1	NONE	OTH	OTH		Multiple Sclerosis	Multiple Sclerosis	NONE~ ()~~~In patient		1						1	Hypoaesthesia; Multiple sclerosis	FLUX~UNKNOWN MANUFACTURER~~7+~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0131953	12/29/1999	OH	57.0	57		M	11/04/1999	Erythema/warmth of 5cm around induration & blistering of nickel size. Occured less than 24 hrs post injection on Fluzone arm.									Y	11/02/1999	11/03/1999	1	NONE	PVT	PVT	Azulfidine, Plaquenil, Prinivil, Tagemet, Vivoxx	NONE	Allergies: Septra, Feldene; Arthritis, Diverticulitis	NONE KNOWN~ ()~~~In patient		1						1	Dermatitis bullous; Injection site hypersensitivity; Injection site mass; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0160AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~463731~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0131960	12/29/1999	NY	58.0	58		F	11/05/1999	Woke up around midnight, vomiting, hot & flushed, coughing & dyspnea. Symptoms subsided when went outside in cold air. Cough lingered into the next day.									Y	11/01/1999	11/02/1999	1		PVT	PVT			NONE	~ ()~~~In patient		1						1	Cough; Dyspnoea; Vasodilatation; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0065AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131961	12/29/1999	WI	77.0	77		F	11/02/1999	On 10/21/99, pt reported fever, sweats, sore throat, coryza, non-productive cough & being very sick since 10/20/99. Went to see MD on 10/26/99, c/o feeling lousy & having stuffy head. Still coryza and loose cough. No pain in arm at anytime.									Y	10/18/1999	10/20/1999	2	NONE	PUB	OTH	OTC for	Felt perfectly well prior to vaccines.	None	~ ()~~~In patient		1						1	Cough; Hyperhidrosis; Malaise; Pharyngitis; Pyrexia; Rhinitis	FLU3~PARKDALE PHARMACEUTICALS~02979P~2~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0131962	12/29/1999	NY	11.0	11		M	11/02/1999	11:10, got pale, laid him down on table. Eyes staring, jerking motions. No resp. distress. Smelling salts used immediately w/instant response. Given lollypop, walked out of office OK. F/up call. No symptoms, doing fine.									Y	11/02/1999	11/02/1999	0	11:10 BP 120/60, Pulse 72   11:25 BP 118/60	PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Hypertension; Muscle twitching; Pallor; Stupor	FLU3~CONNAUGHT LABORATORIES~U0132AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131964	12/29/1999	KY	43.0	43		F	11/17/1999	Febrile, Flu-like symptoms, general malaise, no energy, feeling tired. Woke up in middle of night, heart palpitations.									Y	10/19/1999	10/19/1999	0		MIL	MIL	NONE	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Influenza; Insomnia; Malaise; Palpitations; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131969	12/29/1999	MA	39.0	39		F		Fever 103.5-101 x 3 days; headache, chills, muscle aches, earache, swollen glands, sore throat (severe), cough & erythema of face.									Y	11/15/1999	11/15/1999	0	NONE	PVT	PVT	BCP	NONE	Allergic to Keflex, cats, dogs, general health excellent	~ ()~~~In patient		1						1	Chills; Cough; Ear pain; Headache; Lymphadenopathy; Myalgia; Pharyngitis; Pyrexia; Rash	FLU3~PARKDALE PHARMACEUTICALS~03279P~1~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0131970	12/29/1999	CA	11.0	11		M	11/16/1999	Pt began wheezing 15 mins after his Flu shot. He used his inhaler and wheezing resolved.									Y	11/10/1999	11/10/1999	0		PVT	PVT	Allegra-Albuterol Inhaler	NONE	RAD (Reactive Airway Disease)	~ ()~~~In patient		1						1	Asthma; Condition aggravated	FLU3~CONNAUGHT LABORATORIES~U0155AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131971	12/29/1999	TX	21.0			F	11/18/1999	Pt experienced pain at injection site radiating to lower arm as well as tingling & numbness extending to fingertips; this lasted 3 days; on 4th day site had only soreness at injection site.									Y				NONE	OTH	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~U0160AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131973	12/29/1999	AR				F		Urticaria, induration, erythema. Tx'd with Benadryl 25mg from 11/6/99 to 11/9/99, resolved.									Y	11/04/1999	11/06/1999	2		OTH	PUB	Prenatal Vit, Resperidone, Periactin			~ ()~~~In patient		1						1	Rash; Skin nodule; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466440~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0131975	12/29/1999	PA	42.0	41		F	11/08/1999	Pt c/o itchy face, scalp, hair line, trunk & arms with red blotches that became hives. Tx'd w/Benadryl 25mg po x doses.									Y	11/05/1999	11/05/1999	0		UNK	UNK	UNK		Sulfa allergy	~ ()~~~In patient		1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0152AA~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131976	12/29/1999	AR	93.0	93		F	11/10/1999	11/6 urticaria, induration, erythema. Benadryl 25mg po q4. 11/7 resolved.									Y	11/04/1999	11/06/1999	2		OTH	PUB	Zoloft			~ ()~~~In patient		1						1	Rash; Skin nodule; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0131977	12/29/1999	AR	72.0	72		F	11/10/1999	Redness at and around injection site 6-8cm, itching, erythema, urticaria and induration. Tx'd with Benadryl 25mg 11/6/99-11/9/99, Resolved.									Y	11/04/1999	11/06/1999	2		OTH	PUB	TNG, Lasix, Risperdone, KCL, Megace, DIG			~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466444~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0131978	12/29/1999	AR				F		Pt. had urticaria, induration & erythema. Tx'd with Benadryl 25mg po q 4, 11/6/99-11/9/99, resolved.									Y	11/04/1999	11/06/1999	2		UNK	UNK	Synthroid, Dyazide, Catapres, Petrol.			~ ()~~~In patient		1						1	Rash; Skin nodule; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466444~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0131979	12/29/1999	CA	34.0	34		F	10/29/1999	Pt. was red, sore & warm at injection site. Area approx. 3 x 2 in diameter. Sore for 3 days.									Y	10/20/1999	10/21/1999	1		PUB	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0109BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131981	12/29/1999	AL	70.0	70		M		On 10/25/99, had flu-like aches, all night. On 10/27/99, much sneezing & severe sore throat. On 10/28/99, had nasal stuffiness symptoms, same for a week, bronchial congestion.									N	10/25/1999	10/25/1999	0		OTH	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Bronchitis; Influenza; Pharyngitis; Rhinitis	FLU3~PFIZER\WYETH~4998232~6~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0131983	12/29/1999	IL	1.5	1	.5	M	11/10/1999	Within 24 hrs. of vax., had redness and swelling in both thighs, (L) > (R). Had increased swelling x 48 hrs., then receded and resolved, without treatment.									Y	10/20/1999	10/21/1999	1	NONE	PVT	PVT	Albuterol/NS or Chromogen/Nebulizer	NONE	Asthma, ? fall allergies     No other allergies.	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	DTAP~PFIZER\WYETH~464307~4~IM~LL~DTAP (ACEL-IMUNE)~1|FLU3~CONNAUGHT LABORATORIES~U0145FB~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~PFIZER\WYETH~460103A~4~IM~LL~HIB (HIBTITER)~1|IPV~PASTEUR MERIEUX INST.~P1413~3~SC~RL~POLIO VIRUS, INACT. (NO BRAND NAME)~1	USA		Influenza
0131986	12/29/1999	OH	47.0	47		F	11/08/1999	Severe headache, muscle ache, fever, servere vomiting, these lasted for 5-6 hrs.									Y	10/21/1999	10/21/1999	0		OTH	UNK	NONE	NONE	NONE	~ ()~~~In patient		1						1	Headache; Myalgia; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0127AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131989	12/29/1999	OH	48.0	47		F	11/10/1999	Developed golf-ball sized lump under arm in which flu vaccine was administered approx. 3 days after vaccine. PMD thought it was due to vaccine. (enlarged lymph node)									Y	11/05/1999	11/08/1999	3	NONE	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Lymphadenopathy	FLUX~UNKNOWN MANUFACTURER~~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0131990	12/29/1999	MI	46.0	46		F	10/15/1999	Pt's BP was elevated, appeared flushed & stated her heart felt like it was racing. Pt. felt cold & clammy. Nurse continued to take BP & pulse for next 45 min. By 2:40p.m., pt's BP was normal as well as pulse & respirations.									Y	10/15/1999	10/15/1999	0		OTH	OTH	Tetracycline-for facial rash			~ ()~~~In patient		1						1	Chills; Hyperhidrosis; Hypertension; Rash; Tachycardia; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02879P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0131991	12/29/1999	IA	75.0	75		F	11/15/1999	By the 7th, pt. was a little hoarse but felt fine. Pt. is still hoarse, but better today, 11/15. Pt. drank hot tea with honey and refrained from talking very much.										11/05/1999	11/07/1999	2		PVT	OTH	Stress fighter	NONE		~ ()~~~In patient		1						1	Dysphonia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0131992	12/29/1999	CA	38.0	38		F	11/02/1999	Pt. returned to clinic, 1 1/2 hr. after vax, c/o feeling detached and unable to concentrate. Color pink, skin warm, dry. B/P 112/70, pulse 72. Resp. 18, lungs clear. No sob, trouble swallowing, itching or weakness. Rested, now feels fine.									Y	11/02/1999	11/02/1999	0		OTH	OTH	Estratest, Excedrin	Slight scratchy throat	NONE	~ ()~~~In patient		1						1	Hypotension; Pharyngitis; Thinking abnormal	FLU3~PARKDALE PHARMACEUTICALS~40996010~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0131993	12/29/1999	VA	61.0	61		F	11/15/1999	Erythematous, papular rash to right arm. Tx: Prednisone taper 20mg. Cough & congestion, which wasn't addressed at urgent care. On 10/25 visit, rash was worse; never given Claratin script, as mentioned. Pt. still has rash & deep cough.									N	10/20/1999	10/22/1999	2		OTH	OTH	Prednisone/20mg. Keflex/?500 mg on 10/12	10/11 Allergic rxn/bug bite & cellulitis rt. eye	PC 1987-radiation & Tamoxicin study (7 yrs), asthma, Num. allergies	~ ()~~~In patient		1						1	Asthma; Cough; Rash maculo-papular; Rhinitis	FLU3~PARKDALE PHARMACEUTICALS~03179P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1402H~1~IM~LL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0131994	12/29/1999	NV	29.0	29		F	11/23/1999	Began hives breakout at approx. 7:00 pm on 11/19/99, the day of shot. By 8:00 am on 11/20/99, breakout was all over body. Tx'd with Benadryl over-the-counter pills.									Y	11/19/1999	11/19/1999	0		OTH	OTH	Amitrytriptiline, Wellbutrin		Pencillin, Sulfa	~ ()~~~In patient		1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0131996	12/29/1999	NY	68.0	68		F	11/26/1999	Pain in right arm from flu shot.									Y	11/22/1999			NONE	PUB	PVT	Tylenol after vaccine	NONE	Penicillin allergy	~ ()~~~In patient		1						1	Injection site pain	FLU3~PFIZER\WYETH~4998245~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0132003	12/29/1999	CA	44.0	43		M	10/20/1999	Approx. 48 hrs. after injection, pt. awakened in middle of night, itching w/masses of very small red dots on buttucks, mid-thigh to mid-abd., arms, hands, ankles & pronounced red-rectangular area over injection site. Lasted approx 1 week.									Y	10/13/1999	10/16/1999	3	NONE	UNK	UNK	Multi-Vitimans, low dose ASA	NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~U0109BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132005	12/29/1999	KY	38.0			M	11/18/1999	Pruritic rash, 45 min. after shot. No SOB or swelling.									Y	11/02/1999	11/02/1999	0		MIL	MIL	NONE	NONE	NONE	~ ()~~~In patient		1						1	Pruritus	FLU3~CONNAUGHT LABORATORIES~V0169AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0226H~2~IM~~HEP B (FOREIGN)~1	USA		Influenza
0132007	12/29/1999	HI	52.0	52		F	11/16/1999	Pt's rt. arm was sore 1 hr. after vax. The next morning, it was swollen, red & warm. Later that day, the area doubled in size, increased redness & warmth. Also, had blotchy red spots in the underarm area. Tx'd w/Prednisone & Lipex cream.									Y	10/21/1999	10/22/1999	1	NONE	OTH	PVT		NONE	Compazine	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Lymphadenopathy; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U6152AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~463019~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0132010	12/29/1999		25.0	25		F	11/04/1999	Swollen, painful (L) upper arm w/limited ROM at elbow. Had full flexion but limited extension, also edematous forearm & upper arm. Tx'd w/Prenisone x 5 days, edema was almost gone but pt. c/o discomfort & only lacked 10-15 deg. extension.									Y	11/01/1999	11/02/1999	1	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Hypokinesia; Injection site oedema; Injection site pain; Oedema peripheral	FLU3~PFIZER\WYETH~4998235~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0132011	12/29/1999	MN	34.0	34		F	11/15/1999	Pt. had dizziness, nausea & faint, right away. On 11/8/99, she called to say, she is still having sx's of dizziness, nausea, maybe a temp. & chills, muscular pain in shoulders & neck; arm hurting & hand slightly swollen; cold sx's; by 11/12									Y	11/04/1999	11/04/1999	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	MN99022	1						1	Chills; Dizziness; Myalgia; Nausea; Neck pain; Oedema peripheral; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~01989P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0132012	12/29/1999	OH				U		(L) deltoid pain (shoulder) the day after injection. Never red/swollen, increased soreness w/o known injury. Exam showed pt. improved considerably, consistent w/syn/tendinitis.									U	10/10/1999	10/11/1999	1	NONE	OTH	OTH	NONE	NONE	UNKNOWN	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Tendon disorder	FLU3~PARKDALE PHARMACEUTICALS~03079P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0132014	12/29/1999	WI	30.0	29		F	11/05/1999	Pt. rcv'd vaccine at 12:15 pm. Called at 15:10 pm to report hives. Pt. had spoken with MD's office & stated was going to take Benadryl per MD's advice. Pt. denies diffifulty breathing or hoarseness.									U	11/05/1999	11/05/1999	0		PVT	OTH			No known allergies	~ ()~~~In patient		1						1	Urticaria	FLU3~PFIZER\WYETH~4998263~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0132019	12/29/1999	FL	75.0	74		F	11/04/1999	Pt. developed rash hives on (L) arm + itching and rash on (R) flank hives 1 day post vaccination. Symptoms resolved in 48 hrs.									Y	10/12/1999	10/13/1999	1		PUB	OTH		NONE	UNKNOWN (no previous allergy to Flu Vaccine or eggs)	~ ()~~~In patient		1						1	Pruritus; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~03279P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0132021	12/29/1999	CT	8.0	8		M	11/10/1999	10x10 cm area erythema & edema at site of injection x 3 days, R deltoid.									Y	11/02/1999	11/03/1999	1		PVT	UNK		NONE	LYME DISEASE 2/98	~ ()~~~In patient		1						1	Infection; Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~U0063AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1584H~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0132023	12/29/1999	CA	76.0			M	10/20/1999	Hives and itching, 10:00 p.m., lasting about 30 minutes. Applied Aloe-Vera gel to upper arms, abdomen and thighs.									Y		10/13/1999			OTH	PUB	aspirin	slight cold				1						1	Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0132025	12/29/1999	CA	69.0	69		F	11/05/1999	Onset of pain at site of Pneumococcal vax, immediately. Area of redness was noted 24 hrs. after shot, non-puritic, involving right deltoid area, approx. 19.5x5cm. Vital signs-normal, including normal temp., 11/5/99. Symptoms gone by 11/8/99									Y	11/04/1999	11/04/1999	0		PUB	UNK				~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~MEDEVA PHARMA, LTD.~E29199HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~459041~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0132027	12/29/1999	FL	63.0	63		M	11/12/1999	Pt. developed upper body itching, w/o rash within 24 hrs. of vax. No other sx's reported. Referred to Primary MD. Symptoms decreased by 11/4/99.				Y					U	11/02/1999	11/03/1999	1		PUB	PVT	Zyrtec	NONE	UNK (no previous allergy to eggs or flu vaccine)	~ ()~~~In patient		1						1	Pruritus	FLU3~PARKDALE PHARMACEUTICALS~02189P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0132029	12/29/1999	IL				F		Approx. 1 hr. after vax, pt. became nauseated, cold, diaphoretic, clammy, dizzy and also had 1 bout of LBM. Pt. missed almost a week of work. Went to Dr and was later dx'd w/bronchitis.									Y	10/29/1999	10/29/1999	0	NONE	OTH	PVT		NONE	Asthma; takes inhaler	~ ()~~~In patient		1						1	Asthma; Bronchitis; Chills; Dizziness; Hyperhidrosis; Nausea	FLU3~CONNAUGHT LABORATORIES~U0149CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132030	12/29/1999	MN	49.0	49		M	11/15/1999	Fever, chills, headache, bodyache, exhaustion, injection site inflamed and swollen. Last approx 48 hours.									Y	10/26/1999	10/27/1999	1		OTH	PVT	Centrum vitamin, iron supplement	NONE	Asthma, celiac sprue	NONE~ ()~~~In patient		1						1	Asthenia; Headache; Injection site inflammation; Injection site oedema; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0132032	12/29/1999	CA	52.0	51		F	10/15/1999	Pt was light-headed, cool, clammy and had upset stomach, within 15 to 30 minutes after vax. Increased redness at site, 3 days later and remained sore.										10/12/1999	10/12/1999	0		PUB	UNK				~ ()~~~In patient		1						1	Chills; Dizziness; Dyspepsia; Hyperhidrosis; Injection site hypersensitivity; Injection site pain	FLU3~CONNAUGHT LABORATORIES~U0130AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132890	12/29/1999	MI	1.3	1	.3	M	12/17/1999	After vax, awoke w/ quarter-sized rash on L thigh. Inc to cover approx 2/3 of the L thigh, measured 10x8cm, red swollen, warm. Given abx (Ceftin) empirically for possible cellulitis.				Y					Y	12/03/1999	12/04/1999	1	12/4/99 WBC 13	PVT	PVT	NONE	well child	reactive airway disease	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Rash; Vasodilatation	DTAP~SMITHKLINE BEECHAM~917A2~4~IM~LL~DTAP (INFANRIX)~1|FLU3~PFIZER\WYETH~4998231~1~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HIBV~PFIZER\WYETH~465258~4~IM~LL~HIB (HIBTITER)~1	USA	Emergency room visit	Influenza
0132891	12/29/1999	MI	59.0	58		M	12/16/1999	Pt given .5cc Infuenza vax in L deltoid. Sm amt of bleeding occurred at site. Immediately, raised, reddened are appeared approx 1 dia. Applied cold compress. No respiratory problems noted.									Y	12/16/1999	12/16/1999	0		PVT	PUB			Paxil, No know allergies	~ ()~~~In patient		1						1	Injection site haemorrhage; Injection site hypersensitivity; Injection site oedema	FLU3~PARKDALE PHARMACEUTICALS~02879P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0132895	12/29/1999		49.0	49		F	12/15/1999	Right arm cellulitis; tx w/ antibiotics and anti-inflammatory medication.				Y					Y	12/07/1999	12/08/1999	1	NONE	OTH	MIL		NONE	NONE			1						1	Cellulitis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~CONNAUGHT LABORATORIES~0992680~1~SC~LA~MENINGOCOCCAL (MENOMUNE)~1|TD~LEDERLE LABORATORIES~456053~UNK~SC~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0132899	12/29/1999	CA				U		Post vaccine, while driving home, pt experienced pain from L/arm down to hand.  1 1/2 hr later pain radiated to back of neck. No residual effect post 24 hours.									Y	12/02/1997	12/02/1999	730	NONE	PVT	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Neck pain; Pain	FLU3~MEDEVA PHARMA, LTD.~E30889KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0132910	12/29/1999	WA	39.0	39		F	11/29/1999	Pain in chest with breathing, malaise, feeling of having eated too much; next morning sx's were debilitating - could ot perform simple tasks; when ER MD probed abdomen pain provoked tears.				Y					Y	10/23/1999	10/23/1999	0	Chest X-ray, Full Blood work up, ultrasound of internal organs	OTH	OTH	NONE	NONE	Allergy to cats, dogs, dust, grass, codeine	~ ()~~~In patient		1						1	Abdominal pain; Chest pain; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0132933	12/29/1999	OH	46.0	46		F	12/23/1999	First had erythema nodosom on both knees, 5 days after vax. Tx'd with prednisone and ? other med. and they subsided. On 10/23 developed nausea,sweating and weakness and told by MD she had a flu virus. These symptoms continued and then she					Y	5			N	09/20/1999	09/25/1999	5	MRI, spinal tap was nml.	PVT	PVT	Prednisone,Methotrexate,     Leucovorin		hx of SLE since 1986	~ ()~~~In patient		1						1	Asthenia; Erythema nodosum; Hepatocellular damage; Hyperhidrosis; Nausea; Paraesthesia; Peroneal nerve palsy; Systemic lupus erythematosus; Tachycardia	FLU3~PFIZER\WYETH~4998231~1~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0129968	12/30/1999	CO	72.0	71		F	12/20/1999	Pt reports becoming unconscious-sleeping around the clock waking for phone, told boyfriend not to call MD or 911;also complained of blurred vision.									Y	10/21/1999	10/22/1999	1		PUB	PUB		osteoporosis	osteoporosis	~ ()~~~In patient		1						2	Amblyopia; Arthralgia; Asthenia; Back pain; Coma; Dizziness; Hypokinesia; Visual disturbance; Amblyopia; Osteoporosis; Stupor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~PARKDALE PHARMACEUTICALS~02979P~2~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0132943	12/30/1999	WI	74.0	74		F	12/15/1999	Had flu shot at 3p;woke up at 2a and was dizzy,nauseated,& lost her equalibrium.Tx w/ Meclazine.								Y	N	10/04/1999	10/05/1999	1	11/26/99:Audiometric test-right balance nerve damaged 30%	PUB	PUB			allergy to PCN,sulfa,formalin,neosporin	Had similar symptoms last yr for two weeks following flu shot;date unk~ ()~~~In patient		1						1	Coordination abnormal; Dizziness; Nausea; Neuropathy	FLU3~PARKDALE PHARMACEUTICALS~02089P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Disabling	Influenza
0132946	12/30/1999	OH	72.0	72		F	12/21/1999	10/25 Upset stomach, nausea, gas, sore left shoulder, chills, shaking, heartburn, chest ache, ceased when in bed. 10/26 chest tight, ache returned, hurt to breath. 10/27 same as Tues. Stomach better. Evening ache returned lasting all night.				Y					Y	10/22/1999	10/25/1999	3	EKG, Chest x-ray	PVT	PVT	Premarin, multi-vitamins, calcium	NONE	Osteo-arthritis	NONE~ ()~~~In patient		1						1	Arthritis; Chest pain; Chills; Dyspepsia; Eructation; Nausea; Pain; Pneumonia; Tremor	FLU3~CONNAUGHT LABORATORIES~U0110M~1~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0132948	12/30/1999	IL	48.0	48		M	12/26/1999	Vax on 11/4/99. 12/1 soreness continued in L arm. Unable to sleep on L side. Unable to lifr arm over head.									U	11/04/1999	12/01/1999	27		OTH	PVT	UNK	NONE	NONE	~ ()~~~In patient		1						1	Hypokinesia; Pain	FLU3~CONNAUGHT LABORATORIES~U0129AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132951	12/30/1999	CA	28.0	28		F	12/22/1999	Discoloration, firmness, and tenderness at site of Influenza injection.									N	10/22/1999	10/24/1999	2	NONE	OTH	OTH	NONE	NONE	Seasonal allergies.	NONE~ ()~~~In patient		1						1	Injection site mass; Injection site pain; Skin discolouration	FLU3~MEDEVA PHARMA, LTD.~E30899LA~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0132956	12/30/1999	GA				F	12/20/1999	Pt dvlped atrophic dermatitis at site of injection. 4 cm x 4 1/2 cm darkened area dvlped-hypersensitive to palpation w/ discomfort.									U					OTH	PVT		NONE	allergy to sulfa	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0132957	12/30/1999	CA				F	12/07/1999	11/2, notified by pt (an RN), of pain immediately at time of injection. States she was shot too high. On 11/2, having aching, tingling vibration feeling and arm irritable. On 11/3, still having symptoms.				Y					U	10/12/1999	10/12/1999	0		PUB	PUB				~ ()~~~In patient		1						1	Injection site pain; Paraesthesia	FLU3~PFIZER\WYETH~4998221~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0132968	12/30/1999	CA	48.0	48		M	12/03/1999	Rash on back, generalized, upper buttocks pink, temp 100.5, no resp distress.  Rxed Benedryl Resolved 10/28/99.				Y					Y	10/28/1999	10/28/1999	0	Tests for allergic rxn	PUB	PUB		NONE	Mental Retardation, diaper rash, folliculitis, constipation	~ ()~~~In patient		1						1	Acne; Constipation; Hypersensitivity; Mental retardation severity unspecified; Pyrexia; Rash maculo-papular	FLU3~MEDEVA PHARMA, LTD.~E26919HA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0132984	01/03/2000	MI	34.0			F	12/01/1999	11/30/99 Pt recv vax around 1 pm. Found unable to move finger on  L hand same day. L hand feels numb. Had Drs visit and Dr was noncommittal relating symptoms to vax. Numbness had decreased markedly since 11/30/99.				Y					Y	11/30/1999	11/30/1999	0	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MI99140	1						1	Hypoaesthesia	FLU3~PARKDALE PHARMACEUTICALS~00199P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0132989	01/03/2000	CA	44.0			F	12/06/1999	Post vax, devel headache, cough, fever, & cold sweaty sensation, lost appetite, feels fatigued.									U	11/30/1999	12/03/1999	3		OTH	PVT		Cold or cough?		~ ()~~~In patient		1						1	Anorexia; Asthenia; Cough; Headache; Hyperhidrosis; Pyrexia	FLU3~PFIZER\WYETH~4998251~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0132990	01/03/2000	CA	46.0	45		F	12/03/1999	Pain all over body, aches, erythema 4x3, swelling, heat at inject site (L) deltoid.									Y	11/30/1999	11/30/1999	0	N/A	PUB	PUB	Darvocet, Celebrex	NONE	Poliomyelitis at age 1, allergy to Codeine		CA990160	1						1	Infection; Injection site hypersensitivity; Injection site oedema; Myalgia; Vasodilatation	FLU3~PFIZER\WYETH~498216~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0132991	01/03/2000	CA	63.0	63		F	11/18/1999	30 mins after flu shot, pt almost blacked out and she had to lie down. 911 called. At Cottage Hosp ER, pt thinks saw blood pressure fo 89/56. As of Nov 18, is feeling better but still some weakness.				Y					Y	11/15/1999	11/15/1999	0	BP=89/56??	UNK	UNK	NONE	NONE	NONE		CA990161	1						1	Dizziness; Hypotension	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0133000	01/04/2000	CA	37.0	37		F	12/27/1999	10/16 immed local rxn, servere burning pain, tingling digits 4&5 digit. Redness/warmth at site. 10/17 L/sided neck pain, continued redness/pain at site. Local rxn leading to orange peel look around inject site w/sloughing of skin. 11/3 sev muscle spasm of neck, unable move neck secondary to pain. Marked weakness of L/arm with decreased sensation. 11/4, numbness, tingling and increased L/sided weakness with numbness to L/jaw. Seen in ER. 11/5 L/sided weakness remains unchanged. Saw a neurologist and dx'd with L/sided weakness, marked. Started RX of Skelaxin. 11/12 saw NP and dx'd with marked L/sided weakness. R/o MS, Guillain-Barre Syndrome, brachial neuritis. 12/21 dx'd with L-sided weakness, brachial plexus neuritis, probable/possible reaction to influenza vaccine. Today; I continue with pain, numbness and weakness in my L/arm; mild pain L/side of neck. Pain increases with use of my arm, ie driving, pushing shopping cart, etc.				Y					N	10/16/1999	10/16/1999	0	MRI neck, brain, CBC, 12/60, Lipid panel, Neck xray ALL NORMAL	PVT	UNK	Premarin .625	NONE	NONE			1						1	Dermatitis exfoliative; Guillain-Barre syndrome; Hypertonia; Hypokinesia; Injection site hypersensitivity; Injection site pain; Myasthenic syndrome; Neck pain; Neuritis; Pain; Paraesthesia; Vasodilatation	FLU3~PFIZER\WYETH~4998243~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0132995	01/05/2000	ND	66.0	66		M	11/10/1999	Extreme muscle weakness; required help to move. Noted to be using ancillary muscles for breathing at urgent care. Pt was hospitalized and transferred to Minneapolis.Dx of GBS.				Y	Y				U	10/14/1999	10/31/1999	17		OTH	PUB	opthalmic lubricant, Erythromycin		PCN allergy			1						1	Dyspnoea; Guillain-Barre syndrome; Myasthenic syndrome	FLU3~MEDEVA PHARMA, LTD.~E29179HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0132996	01/05/2000	CA	18.0	17		F	12/24/1999	Cellulitis in deltoid with seroma formation; requiring hospitalization & surgical incision & drainage.  Pt developed large area of redness at injection site.					Y	5			Y	12/01/1999	12/01/1999	0	WBC-12.1	PVT	PVT	Claritin, Flunase	NONE	NONE	~ ()~~~In patient		1						1	Cellulitis; Injection site reaction; Leukocytosis	FLU3~PFIZER\WYETH~4998287~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~SMITHKLINE BEECHAM~ENG3088A2~1~IM~RA~HEP B (ENGERIX-B)~1|PPV~MERCK & CO. INC.~1692H~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0132998	01/05/2000	WA	54.0			F	12/29/1999	11/4/99, noticed paralysis of L/side of face. 11/5/99, evaluated by PMD-Dx: Bell's Palsy. Placed on prednisone & antiviral meds.									N		11/04/1999		NONE	PUB	PVT	PPD test, Spironolactone, Amitriptyline, Digoxin, Valium, Relafin, Pepsid, Estrace II	NONE	Allergies, Tegretol,Dilantin,Sulfa,Codiene<Amoxecillin,Hydrops L/ear,Poly-facial neuralgia, Osteoarthritis			1						1	Facial palsy	FLU3~CONNAUGHT LABORATORIES~U01577AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0133017	01/05/2000	CA	49.0	49		M	12/28/1999	Generalized urticaria 1 day after vaccine administration. 2nd day, to ER. Tx'd w/Dexamethasone injection and oral Prednisone f/u.				Y					Y	12/01/1999	12/02/1999	1		PVT	PVT		NONE	NONE	~ ()~~~In patient		1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~U0163AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~U0072AA~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1|YF~CONNAUGHT LABORATORIES~UA137AA~1~SC~RA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0133019	01/05/2000	CO	62.0	62		F	11/02/1999	Swelling, warmth and redness at site of injection. Hives on both forearms with pruritus. Responsive to Benadryl.									Y	10/25/1999	10/25/1999	0	NONE	OTH	PVT	NONE now/Had breast Ca-1/99 w/Radiation	NONE	Breast Ca, Seafood allergy	~ ()~~~In patient		1						1	Breast cancer; Injection site hypersensitivity; Injection site oedema; Pruritus; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~03279P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0133022	01/05/2000	OR	3.0	3		M	12/17/1999	Within a few hrs of vax administration, vomiting, rash, description consistant with hives on lower extremity/face, followed by a 2 white bump rash on trunk. No fever. Had pruritus, resolved by next am and remained asymptomatic.									Y	11/17/1999	11/17/1999	0	NONE	PVT	PVT		NONE	Prune belly syndrome,GU Reflux,Hydronephrosis,Asthma	~ ()~~~In patient	OR9947	1						1	Asthma; Congenital genitourinary abnormality; Gastrointestinal malformation; Hydronephrosis; Pruritus; Urticaria; Vomiting	FLU3~CONNAUGHT LABORATORIES~V0170AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0133026	01/05/2000	CA	49.0	49		F	09/25/1999	Area red, hot, raised x 4 days post injection. 9/27/99, pt states arm fine now w/no problems.									Y	09/21/1999	09/21/1999	0		PUB	OTH	Cefezil/Tyliprn	NONE	Allergic to Tetracyline	~ ()~~~In patient		1						1	Injection site hypersensitivity; Rash maculo-papular	FLU3~PFIZER\WYETH~4998230~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0133033	01/05/2000	OK	53.0	53		M	11/23/1999	Pain in arm & R/hand 1 wk after injection to date reported 11/23/99. Injection given 11/5/99. Also, noticed a knot at injection site, 7x7mm hard knot on R/upper arm, warm to touch.									U	11/05/1999	11/12/1999	7	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	OK9960	1						1	Injection site hypersensitivity; Injection site mass; Pain	FLU3~PARKDALE PHARMACEUTICALS~02089P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0133034	01/05/2000	OK	76.0	75		F	12/17/1999	3 yrs ago took flu shot - had extreme ridigity in both legs (lasted 15 months). Barely able to walk with help. Next yr took flu shot - no problem. 10/2/99 - took flu shot, developed extreme rigidity in both legs 9 days later. See Comments				Y					N	10/02/1999	10/11/1999	9		OTH	OTH	NONE	NONE	NONE	Patient-Flu Vaccine-1 in series / ridigity in both legs and trouble walking~ ()~~~In patient	OK9965	1						1	Gait disturbance; Hypertonia	FLUX~UNKNOWN MANUFACTURER~~3~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0133036	01/05/2000	OK	36.0	36		F	12/03/1999	6:30pm, riding home in car, coughed a little. 6:50pm, blotches of swelling inside of cheeks & inside of bottom lip which lasted until 10:00am, 12/2/99. Thought throat felt constricted a little; gone by next am. Felt hot, cold/achey/sore/									Y	11/30/1999	11/30/1999	0	NONE	PUB	OTH	NONE	NONE	NONE	~ ()~~~In patient	OK9963	1						1	Asthenia; Chills; Cough; Face oedema; Laryngospasm; Myalgia; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02089P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0133037	01/05/2000	OK	49.0	49		F		10/21/99 hives 11/15/99. Seen MD 11/18/99 & seen Dermatologist 12/2/99. Has stopped all lotions & creams. Denies change in detergents, soaps, new meds. No changes. Continues to have hives.				Y					N	10/21/1999	11/15/1999	25	UNK	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	OK9962	1						1	Urticaria	FLU3~PARKDALE PHARMACEUTICALS~02089P~7+~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0133041	01/05/2000	CA	57.0	57		F	12/09/1999	Reportedly, pt. developed symptoms eventually diagnosed as Guillain-Barre Syndrome. Starting a few days after vaccine, she dvlped flank pain, numbness, and ataxia. She is currently at Rehab.60 day follow-up received on 10/17/00 states that the pt has partially recovered.			Y		Y				N	10/26/1999	10/28/1999	2		PUB	PUB		UNK	UNK		CA990152	1						1	Abdominal pain; Coordination abnormal; Guillain-Barre syndrome; Paraesthesia; Guillain-Barre syndrome	FLU3~MEDEVA PHARMA, LTD.~E27979HA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~E27979HA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Life Threatening,Hospitalisation	Influenza
0133043	01/05/2000		23.0			F	12/30/1999	Systemic Lupus Erythematosis, 2 days post vaccination, pt developed fever, nausea, vomiting, fatique, and arthralgias. 2 wks post vaccination, pt developed flu-like illness, cough, vomiting, diarrhea, fever, arthralgias, facial rash. 60 day follow-up received on 10/25/00 provided no additional data.				Y	Y	4			U				Chest x-ray (plural effusion), wbc=27000 w/26% lymphocytes, serum ANA=1:640,hemoglobin=9.7g/dl. Western erythrocyte sed rate of 52 mm/h; diagnostic laboratory, Sm antigens; diagnostic laboratory, <10, antibodies to double-stranded DNA increased; Sjrogen's antigen, prese; hemoglobin, 9.7g/dl; ribonucleoprotein, prese; temperature measurement, 102 degree; WBC count, 2,700 cells; serum ANA, prese, titer of 1:640; erythrocyte, 52mm/h; component C4 test, <8mg/dL, 15, 45, decreased; component C3 test, 29 mg/dL, 86, 184, decreased; lymphocyte count, 26%	OTH	OTH			Unknown		WAES99122103	1						1	Alopecia; Anaemia; Arthralgia; Asthenia; Cough; Diarrhoea; Influenza; Leukocytosis; Mouth ulceration; Pleural effusion; Pyrexia; Rash; Red blood cell sedimentation rate increased; Systemic lupus erythematosus; Vomiting	DT~UNKNOWN MANUFACTURER~~UNK~IM~RA~DT ADSORBED (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~UNK~SC~UN~MENINGOCOCCAL (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~IM~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|OPV~UNKNOWN MANUFACTURER~~UNK~PO~MO~POLIO VIRUS, ORAL (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0131009	01/06/2000	CA	55.0	55		M	11/17/1999	Pt called clinic and stated that 2 days after receiving flu vaccine, felt general weakness.  Ever since continues to feel weak and states it is a reaction to the flu vaccine.									U	11/08/1999	11/10/1999	2		PUB	PUB	NONE	NONE	NONE		CA990148	1						2	Asthenia	FLU3~MEDEVA PHARMA, LTD.~33609KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0132100	01/06/2000	VT				F	12/08/1999	At time of visit on 10/20/99, pt had 3 cm triangular erythema, edema, warmth, & tenderness. Pt states significant decrease of symptoms at time of visit from appearance on day of vaccination.				Y					Y	10/19/1999	10/19/1999	0	NONE	PVT	PVT		NONE	codeine allergy, environmental allergies	Pt exp erythema 1 yr ago following flu shot.~ ()~~~In patient		1						2	Oedema; Pain; Rash; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~03179P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0132408	01/06/2000	MA	54.0			F	12/06/1999	Rec'd flu shot, felt immed pain-muscle of arm. Headaches everyday to present. 11/2 pain arm, hands, fingers. Pain neck inc. 11/8 pain-arm, neck, shoulders-extreme. 11/10 wake up w/ eyes burning, weeping & cont to burn & hurt to present.									N		10/30/1999		Blood tests norm, EMG-norm, xrays of back & neck show norm wear & tear, MRI-minomal wear & tear.	PVT	UNK	Levoxyl	NONE	Allergy to oil base inject. Graves disease.			1						1	Arthralgia; Back pain; Conjunctivitis; Eye pain; Headache; Lacrimal disorder; Myalgia; Neck pain; Pain	FLU3~SANOFI PASTEUR~V0136AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132409	01/06/2000	LA	64.0	64		M	11/08/1999	11/3 4 days post vax, started itching, no rash. Broke out next day. Told at ER had poison ivy. Presents today w/ red raised rash on R arm from antecubital area to outer lower arm. No rash on L, pt stated did have on 11/6. Private MD felt Per follow-up: Pt received the flu and pneumonia vaccine on 10-29-1999. Pt here today stating he started itching on 11 3-1999 or 11-4-1999, but had no rash. Stated on 11-5-99 broke out in rash on right arm and had itching around ankles. States went to hospital to the ER. States was told he had poison ivy and was given CELESTONE injection and was told to take BENADRYL over the counter. States was also given cream to put on rash. Presents today with red raised rash on right arm from antecubital area down outer lower arm. No rash noted on left arm pt stated did - have rash on left arm on Sat 11/6 or Sunday 11-7. Pt went to private MP Dr. Pt's wife reported that Dr felt rash was due to pneumonia vaccine.				Y					Y	10/29/1999	11/03/1999	5		UNK	UNK	Mysoline, Propranolol, Etoddac, Clonazep	No acute illness	PCN allergy, dx w/ Cerebellar Ataxia & Cervical dystonia		LA991203	1						1	Pruritus; Rash maculo-papular	FLU3~SANOFI PASTEUR~U0156AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0871H~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0132410	01/06/2000	CT	51.0			F	12/06/1999	Swelling & erythema over deltoid extending to shoulder & down to elbow pain, decreased rang of motion, fever to 100.				Y					Y		11/15/1999		NONE	PVT	UNK	MANY	NONE	PCN, Doxycycline - allergies			1						1	Hypokinesia; Injection site hypersensitivity; Injection site oedema; Oedema; Pain; Pyrexia; Rash	FLU3~PFIZER\WYETH~4998251~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0132411	01/06/2000	IL	48.0	48		M	11/10/1999	Pt c/o difficulty breating, fast heart rate, dizziness, BP 100/60, RR 36, pulse 120, unable to hear lung expiration.  Bp prior to immunization 130/66.  Called 911, took pt to Hospital.				Y					Y	11/06/1999	11/06/1999	0		OTH	OTH			NKA	~ ()~~~In patient	IL99077	1						1	Dizziness; Dyspnoea; Hypotension; Tachycardia	FLU3~PFIZER\WYETH~4993247~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0132415	01/06/2000	KY	34.0	34		M	11/29/1999	Approx 5-10 mins after vaccine, pt c/o of weakness, lightheaded, pounding headache, color pale, hands trembling, BP 128/80, 134/94, 160//80.  Benadryl given, 911 called. Developed rash and hives at hospital, tx for allergic react to vax.				Y					U	11/10/1999	11/10/1999	0		PUB	PVT		NONE	PCN, Bee stings	~ ()~~~In patient	KY990059	1						1	Dizziness; Headache; Hypersensitivity; Hypertension; Myasthenic syndrome; Pallor; Rash; Tremor; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~02979P~2~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0132417	01/06/2000	KY	73.0	73		M	11/29/1999	Death due to CHF, no autopsy.	Y	10/22/1999							N	10/18/1999				UNK	UNK				~ ()~~~In patient	KY990062	1						1	Right ventricular failure	FLU3~PARKDALE PHARMACEUTICALS~031779P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Results in Death	Influenza
0132420	01/06/2000	IL	40.0	40		F	11/04/1999	Pt stated 2 day post vax, she is very sick, c/o fever, chills, difficulty breathing, dizziness and weakness.  Pt was encouraged to come to Health Center to see MD.  She failed to come in.60 day follow-up dated 9/26/00 provided no additional data.									U	11/02/1999	11/04/1999	2		PUB	PUB	Adalat, Inderal, Tagamet	Denies illness at time of vaccination	Allergy to sulfa, ibuprofen, calciu, ultram, Hx of htn, migraines, GI bleeding and pain		IL99076	1						1	Asthenia; Dizziness; Dyspnoea; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E24259GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0132424	01/06/2000	IL	64.0	64		M	11/19/1999	Pt reports sore at inject site, swollen from shoulder to elbow with heat at area, was hard to the touch and red in appearance.  Received inject in r/arm with local reaction.  Had fever with chills c/o SOB with ambulation.									N	11/17/1999	11/17/1999	0		PUB	UNK	Procardia, Prilosec	NONE	Has Scleraderma, Rynauds Gastric Reflux	~ ()~~~In patient	IL99081	1						1	Dyspnoea; Injection site hypersensitivity; Injection site mass; Oedema; Pain; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~00499P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~458746~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0132427	01/06/2000	IL	52.0	52		M	11/19/1999	Developed rash on fingers, r/hand and l/forearm.  Received flu shot 11/8/99.  Noticed symptoms 11/9/99.  Hydrocortisone 1% topically.									Y	11/08/1999	11/09/1999	1		OTH	PVT	Naprosyn	NONE	NONE	~ ()~~~In patient		1						1	Rash	FLU3~CONNAUGHT LABORATORIES~U0156AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132428	01/06/2000	UT	44.0	44		F	11/12/1999	After shot, arm was tender at inject site, 2 days later tenderness spread and into arm pit.  For the last week, tenderness has moved down patients r/side to about breast level.									Y	11/21/1999	11/23/1999	2		PUB	OTH	Estrace	NONE	NONE	~ ()~~~In patient	UT992239	1						1	Injection site pain; Pain	FLU3~PARKDALE PHARMACEUTICALS~02979P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0132430	01/06/2000	IN	36.0	36		F	11/16/1999	Local reaction 3-4 cm redness, induration, heat, pain at 48 hours.									U	11/03/1999	11/04/1999	1		OTH	OTH	Skelaxin			~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~4099610~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~458586~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0132450	01/06/2000	IL	11.0	11		F	11/19/1999	Fever to 104.6 after medication. Eyes swelling shut.				Y					N	11/12/1999	11/12/1999	0	Strep, CBC, urine culture in ER-negative	PVT	PVT	Azmacort, Proventil, Singulair	diarrhea	Asthma	~ ()~~~In patient		1						1	Asthma; Diarrhoea; Face oedema; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0132452	01/06/2000	MA	78.0	78		F	12/26/1999	Itch arms, backs of hands, both sides of race. Rash & vesicles noted 11/24 with weeping.				Y					Y	11/15/1999	11/18/1999	3	NONE	PUB	PUB	Meds for BP & Angina, Allergra.	NONE	Allergies to molds, dust, etc. Agina and irregular BP.	Sister had reaction to flu vax.~ ()~~~In Sibling		1						1	Agitation; Dermatitis bullous; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0107AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0132455	01/06/2000	VA	19.0	19		M	12/06/1999	Father stated that 10 hrs post vax, pt developed severe hives from chin to toes and ended up in the ER.  He was treated with steroids and benadryl.				Y					N	11/24/1999	11/24/1999	0		MIL	MIL		NONE		~ ()~~~In patient		1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~~UNK~IM~~HEP B (RECOMBIVAX HB)~1|MEN~CONNAUGHT LTD.~~UNK~SC~~MENINGOCOCCAL (MENOMUNE-A/C)~1	USA	Emergency room visit	Influenza
0132458	01/06/2000	GA	32.0	32		F	10/18/1999	Fever of 105. Chills, local rxn from near elbow to near shoulder top of right arm. Hot to touch, red, & swollen, tingling. Client states tha tshe intends to continue with flu and/or Pneumovax- as recommended.									Y	10/14/1999	10/15/1999	1		PUB	PVT		NONE	NONE		GA99147	1						1	Injection site hypersensitivity; Injection site oedema; Paraesthesia; Pyrexia; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E24249GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1693H~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0132459	01/06/2000	GA	37.0	37		F	10/20/1999	On 10/15/99, L/arm was very swollen, tender & warm to touch and large area of redness. Can't lift arm high enough to open car door. Pt returned on 10/18/99, but wasn't able to wait. Messages returned from pt, states much better.									Y	10/14/1999	10/15/1999	1		PUB	PUB		NONE		~ ()~~~In patient	GA99150	1						1	Hypokinesia; Injection site hypersensitivity; Injection site oedema; Pain	FLU3~PARKDALE PHARMACEUTICALS~03279P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1402H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0132460	01/06/2000	GA	56.0	56		F	10/20/1999	10/14 2 days post vax, pt c/o redness, tenderness with swelling & fever at site R deltoid. 23x20 red hardened area just below inject site. Area inc warm to touch. 10/15 site lger but swelling/tenderness dec. 10/20 problem resolved.									Y	10/12/1999	10/14/1999	2		PUB	PUB	N/A	NONE	KNA	N/A~ ()~~~In patient	GA99151	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~03279P~4~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1402H~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0132461	01/06/2000	GA	54.0	54		F	10/25/1999	R arm at site of inject is red, swollen, and painful.  Pt advised to take ibuprofen and call back if no change or worsened. Did not call back.									U	10/21/1999	10/22/1999	1	N/A	PUB	PUB	NONE	NONE	NONE KNOWN	N/A~ ()~~~In patient	GA99154	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~03279P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1402H~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0132462	01/06/2000	GA	39.0	38		F	10/26/1999	Vax rcv'd at noon. By 5:00 pm redness dvlped. Orange-sized knot dvlped by 24th which was hot to touch.									Y	10/22/1999	10/22/1999	0	NONE	PUB	PUB	NONE	NONE	EPILEPSY	~ ()~~~In patient	GA99155	1						1	Skin nodule; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~0297AP~3~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0132464	01/06/2000	GA	64.0			F	10/27/1999	Pneumonia vax was given and later that day pt exp soreness of rt deltoid. Arm became swollen around inject site to size of a baseball w/ redness. Also complains of nausea & dizziness.									Y					PUB	PUB		NONE		~ ()~~~In patient	GA99157	1						1	Dizziness; Injection site hypersensitivity; Injection site mass; Injection site pain; Nausea	FLU3~PFIZER\WYETH~4998290~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1402H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0132465	01/06/2000	GA	40.0	40		F	10/27/1999	Pt recv'd influenza & pneumococcal vax on 10/12/99. Pt stated that on 10/13/99 her arm near the pneumo vax site was hot & swollen up to armpit. On 10/14/99, pt came into clinic w/ swelling,redness,& heat at inject site.									Y	10/12/1999	10/13/1999	1		PUB	PUB				~ ()~~~In patient	GA99158	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~03279P~7+~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1402H~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0132466	01/06/2000	GA	76.0	76		M	10/28/1999	Reaction noticed 10/27/99 at 10am. Rt arm swollen from elbow to mid-arm. Measured 11 3/4  around. Lt arm measuring 10 1/2  around. On 10/29/99, rt arm back to normal size.									Y	10/26/1999	10/27/1999	1	NONE	PUB	PUB				~ ()~~~In patient	GA99160	1						1	Oedema peripheral	FLU3~PARKDALE PHARMACEUTICALS~02289P~7+~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~455938~2~SC~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0132467	01/06/2000	GA	63.0	63		F	10/28/1999	Pt complains of redness & swelling to injection site of lt arm, problem began the day after receiving injections & is still present. Pt using cold compresses to reduce swelling.									Y	10/20/1999	10/21/1999	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	GA99161	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PARKDALE PHARMACEUTICALS~01989P~4~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~CONNAUGHT LABORATORIES~U0011AA~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0132468	01/06/2000	GA	55.0	55		F	10/29/1999	Pt w/ 50 mm red area over lt arm below injection site. Pt states the morning after the injection, the area was hot & raised but seems to be resolving now.									Y	10/25/1999	10/26/1999	1		PUB	PUB	Premarin, Provera	NONE	NONE	~ ()~~~In patient	GA99162	1						1	Injection site mass; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~01989P~7+~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~CONNAUGHT LABORATORIES~U0011AA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0132469	01/06/2000	GA	22.0	22		F	11/01/1999	Adverse event started a couple of hrs after vax was given; arm became warm to touch & swollen greater than 50 cent piece. Neck also sore and swollen.									Y	10/29/1999	10/29/1999	0		PUB	PUB		NONE	NONE	~ ()~~~In patient	GA99163	1						1	Neck pain; Oedema; Oedema peripheral; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~00199P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0132470	01/06/2000	GA	44.0	44		F	11/01/1999	Lt arm where vaccine was given has a red area just above elbow the size of an orange which is warm to the touch.									Y	10/29/1999	10/29/1999	0		PUB	PUB		NONE	NONE		GA99164	1						1	Injection site hypersensitivity	FLU3~PARKDALE PHARMACEUTICALS~00199P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0132471	01/06/2000	GA	66.0	66		M	11/01/1999	Woke up feeling congested in sinus area, nose runny, ears hurting and thought he had a fever but has not taken temp. Has been taking Tylenol Sinus. Feeling better today. Pt states on 11/2, his throats a little sore but all else is better.									Y	10/28/1999	10/30/1999	2	NONE	PUB	PUB	Tylenol Sinus since 10/30/99	NONE	NONE	~ ()~~~In patient	GA99165	1						1	Ear pain; Pharyngitis; Rhinitis	FLU3~PARKDALE PHARMACEUTICALS~01989P~2~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~CONNAUGHT LABORATORIES~U0011AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0132474	01/06/2000	GA	39.0	39		F	11/16/1999	C/o having tenderness & redness at injection site.									Y	10/29/1999	10/29/1999	0	NONE	PUB	PUB	NONE	NONE	NONE	Had same rxn with previous Flu shots.~ ()~~~In patient	GA99169	1						1	Injection site hypersensitivity; Injection site pain	FLU3~CONNAUGHT LABORATORIES~U0118AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0132476	01/06/2000	GA	67.0	67		M	11/18/1999	Next morning, pt noted erythema & edema at injection site & above. Erythema continued down arm to elbow w/soreness. Pt applying warm compresses at present. To see PMD.									U	11/16/1999	11/17/1999	1	NONE	PUB	PUB	MVI, ASA	NONE	NONE	~ ()~~~In patient	GA99171	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~4099G010~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1692H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0132477	01/06/2000	VA	56.0	56		F	11/26/1999	My underarm became sore. This time it lasted longer (8 days) & was more pronounced. At times it felt  like a knife stabbing into the upper right (toward torso) quadrant of my left armpit. Moving my arm was not a factor.									Y	10/30/1999	10/30/1999	0	NONE	PUB	OTH	Triamterene/HCTZ75/50mg, Premarin, Promerium,Aspirin, Centrum  Silver, Caltrate, Vitamins E & C, Garlic	NONE	High B/P-controlled	Sore armpit, shortly after Flu vax.~ ()~~~In patient		1						1	Pain	FLU3~PFIZER\WYETH~4998261~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0132482	01/06/2000	OH	34.0	34		M	11/22/1999	Chills, diarrhea.									Y	10/19/1999	10/19/1999	0	N/A	PUB	PVT	N/A	N/A	N/A	~ ()~~~In patient		1						1	Chills; Diarrhoea	FLU3~PARKDALE PHARMACEUTICALS~4099G010~2~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0132485	01/06/2000	WA	27.0	27		F	11/28/1999	Pain, dec rang of motion & strength in L shoulder. Significant discomfort x 10 mos. Treated with cortisone inject, anti-inflammatories, phys therapy, massage, accupuncture, chinese herbs.									Y	10/27/1998	10/27/1998	0	Ultrasound, CT scan - bone damage to head of humerus noted.	PUB	PUB				~ ()~~~In patient		1						1	Arthralgia; Asthenia; Bone disorder; Hypokinesia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0132489	01/06/2000	OH	42.0			F	11/23/1999	7 hrs post vax, I exp a total hot flash, then chills and vomiting. It felt like an intense case of the flu but only lasted about 30 min.									Y		10/19/1999		N/A	PUB	PVT	N/A	NONE	NONE			1						1	Chills; Influenza; Vasodilatation; Vomiting	FLU3~PARKDALE PHARMACEUTICALS~4099G010~2~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0132492	01/06/2000	OH	43.0			M	11/22/1999	Chills- severe, muscle aches.									Y		10/20/1999		N/A	PUB	PVT	N/A	N/A	Penicillin			1						1	Chills; Myalgia	FLU3~PARKDALE PHARMACEUTICALS~40996010~2~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0132493	01/06/2000	NC	47.0			F	12/02/1999	Post vax, L deltoid area was swollen immediately, larger than a tennis ball. Became flushed and jittery, faint, devel ascending hives both arms, chest and up neck.									Y		11/01/1999			UNK	UNK	Insulin (regular NPH)	Dizzy spells (wearing heart monitor)	No known allergies			1						1	Dizziness; Injection site oedema; Nervousness; Urticaria; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~4998231~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0133048	01/06/2000	OH	78.0	77		F	11/10/1999	Began aching and feeling bad about 4pm. Felt so bad, was afraid to drive home.  Immediately went to bed slept 1 hours woke with terrible pain behind eye, lasted all night.  Took ASA and Tylenol without relief. Swelling on face and neck.				Y					Y	10/28/1999	10/28/1999	0	CT Scan	PUB	PUB	Paxil	NONE	CVA / 96, blood clots in lungs 10/98	~ ()~~~In patient	OH99095	1						1	Eye pain; Face oedema; Insomnia; Myalgia; Oedema	FLU3~PFIZER\WYETH~4998272~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0133062	01/06/2000	VA	75.0	75		M	12/06/1999	Approx 7:30pm, pt got really cold w/chills. Around 11:30pm, pt became really hot & nauseated. Took Bufferin, temp 102. Went to ER after taking 2nd Bufferin, temp in ER was 101. Took Phenergan; next day, no further symptoms.				Y					Y	11/23/1999	11/23/1999	0	CXR, Urinalysis-Neg (according to pt)	PUB	PUB	Vasotec	NONE	NKA	~ ()~~~In patient	VA99068	1						2	Nausea; Pyrexia; Chills; Nausea; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0110AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~456690~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1|FLU3~CONNAUGHT LABORATORIES~U0110AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~456690~1~IM~RA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0133063	01/06/2000	AZ	54.0	54		F	12/07/1999	Rash, temp of 101 on evening of vax. L arm swollen, painful, pt hardly able to move. 11/11 L arm erythema & hard area at inject site, extending to lateral aspect of upper L arm. 11/12 hypotension. 11/13 pt returned to norm activities.				Y					Y	11/09/1999	11/09/1999	0	NONE	PVT	PVT	Ziac, Prozac, Zanaflex	NONE	Hypertension, migraine headaches			1						1	Hypokinesia; Hypotension; Injection site mass; Oedema; Pyrexia; Rash	FLU3~CONNAUGHT LABORATORIES~U0133AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0044J~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0133070	01/06/2000	ND	78.0	78		M	11/15/1999	Pain, redness, swelling from inject site to fingers. Unable to raise arm. Friday evening started, by Monday was quite improved.				Y					Y	11/11/1999				PVT	PUB		NONE	NONE		ND9924	1						1	Hypokinesia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Oedema peripheral; Pain; Vasodilatation	FLU3~PFIZER\WYETH~4998251~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~463730~1~~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0133071	01/06/2000	CA	64.0	64		M		64 Yr old with mild GBS 4 days after receiving flu shot. Pt could barely walk; his legs were asleep up to his waist. Tx w/ shock treatments and dxed w/ GBS.				Y					Y	10/18/1999	10/23/1999	5	MRI-neg, EMG-abnl	PVT	UNK		NONE	NONE			1						1	Guillain-Barre syndrome	FLU3~PFIZER\WYETH~4998242~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~459040~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0133077	01/06/2000	MA	57.0	57		M	10/22/1999	The evening following immunization in R/arm, it became very painful & throbbing. In pm, unable to move arm & not feeling well. Today, arm is red & very swollen. Advised to see MD & keep elevated w/ice. Tx'd w/Cephalexin.				Y					U	10/20/1999	10/20/1999	0		PVT	PUB	Glucaphage, B/p meds, Necroxase	NONE	Environmental allergies, some Emphysema	~ ()~~~In patient		1						1	Hypokinesia; Malaise; Oedema; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0107AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1585H~UNK~~RA~PNEUMO (PNEUMOVAX)~1|TD~MASS. PUB HLTH BIOL LAB~TD65~UNK~IM~LA~TD ADSORBED (TDVAX)~1	USA	Emergency room visit	Influenza
0133078	01/06/2000	MA	71.0	71		F	10/25/1999	By 8:00pm, R/upper arm, swollen, red, painful, warm to touch. On 10/23, saw MD & placed on antibiotic rx. On 10/25, pain going away & redness decreasing.				Y					Y	10/22/1999	10/22/1999	0		PUB	PUB	Atenolol-Lescol, Bufferin, Prempro, Vitamins	NONE	High B/P, High Cholesterol	~ ()~~~In patient		1						1	Oedema; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0107AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1585H~UNK~~RA~PNEUMO (PNEUMOVAX)~1|TD~MASS. PUB HLTH BIOL LAB~TD65~UNK~IM~LA~TD ADSORBED (TDVAX)~1	USA	Emergency room visit	Influenza
0133079	01/06/2000	MA		28		F	11/04/1999	Swollen arm, red rash, hot to touch, dizzy, nausea & running a fever for 3 days following-sore throat & pharyngitis. Rx'd Atarax for arm.				Y					Y	11/02/1999	11/03/1999	1		PVT	PUB	Depo-provero	NONE	Penicillin	~ ()~~~In patient		1						1	Dizziness; Laryngitis; Nausea; Oedema; Pharyngitis; Pyrexia; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0107AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1585H~UNK~~RA~PNEUMO (PNEUMOVAX)~1|TD~MASS. PUB HLTH BIOL LAB~TD65~UNK~IM~LA~TD ADSORBED (TDVAX)~1	USA	Emergency room visit	Influenza
0133080	01/06/2000	MA	56.0	56		M	10/08/1999	Began experiencing redness, swelling of upper arm, chills & fever, at night. 10/8, Continued w/pain & swelling, advised to see MD. Saw MD 10/8 & given injection of antibiotic & Rx for same & told to keep arm in sling & elevated.				Y					Y	10/05/1999	10/05/1999	0		PVT	PUB	Topral	NONE	High B/P	~ ()~~~In patient		1						1	Oedema; Pain; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0107AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1585H~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0133084	01/06/2000	OH	55.0	55		F	11/22/1999	Pt developed reddened, raised, itchy-like rash about midsection. After course of next 2 days, rash worsened & spread over trunk. Early am of 11/6/99, pt awakened with difficulty breathing & swollen tongue. Went to ER.				Y					Y	11/01/1999	11/02/1999	1		PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient	OH99088	1						1	Dyspnoea; Rash maculo-papular; Tongue oedema	FLU3~CONNAUGHT LABORATORIES~U0167AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0133085	01/06/2000	TN	1.0	1	.6	M	11/22/1999	Pt presented within 24 hrs after vaccine w/hives. Rash lasted about 7 days. Seen in ER, 10/30/99 & given Atarax.				Y					Y	10/26/1999	10/27/1999	1	NONE	PVT	OTH	Rondec-DM	URI	NONE	~ ()~~~In patient		1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~U0132A~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0133086	01/06/2000	ND		46		U		Pt injection site, immediately, swelled & tingly. Had SOB, minimal difficulty swallowing, dry mouth. Said could hear nurse talking but could not speak. Epi 0.5cc given, 02 applied, V/S monitored. Called pt, EMS took to ER at hospital.				Y					Y	10/12/1999	10/12/1999	0		OTH	OTH	Premarin, Previcid	NONE	NONE	~ ()~~~In patient		1						1	Dry mouth; Dysphagia; Dyspnoea; Injection site oedema; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~U0136AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0133087	01/06/2000	MS	46.0	46		F	10/19/1999	C/o severe diarrhea w/cramps, SOB, which started on 10/13. Saw DR upon recommendation of nurse. Pt stated symptoms lasted x2 days, no Tx. Spoke w/DR, pt c/o dyspnea/diarrhea, but was not dyspenic at time of exam.				Y					Y	10/12/1999	10/13/1999	1	NONE	PUB	PUB	NONE	NONE	Pt given Rx for sinus infection on 10/13/99	~ ()~~~In patient	MS99052	1						1	Abdominal pain; Diarrhoea; Dyspnoea	FLU3~PFIZER\WYETH~4998232~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0133089	01/06/2000	NV	38.0	38		F		Cellulitis at site of shot, aches & fever.				Y					Y	10/28/1999	10/29/1999	1	CBC, ANA, Sed Rate	PVT	PVT	Zoloft	NONE	Allergic to Penicillin, Erytho, Sulfa, Cipro,  Flexin, Codeine	~ ()~~~In patient		1						1	Cellulitis; Injection site reaction; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~4998247~7+~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0133104	01/06/2000	ME	1.0	1	.2	F	11/29/1999	Seizure; respiratory distress at home. Fever 100.									Y	11/23/1999	11/24/1999	1	Urine	PVT	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Convulsion; Dyspnoea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0157AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0133111	01/06/2000	MI	44.0	44		M	12/03/1999	Pain Trapezius muscle distribution & lower cervical spine discomfort. No numbness or muscle weakness.									U	11/23/1999	11/24/1999	1	NONE	PUB	OTH	NONE	NONE	NONE	~ ()~~~In patient		1						1	Neck pain; Pain	FLU3~PFIZER\WYETH~499254~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0133113	01/06/2000	CA		64		M		Pt recv'd flu shot & 4 days later developed tingling from the hips down.Nerve conduction study was consistant w/GBS.Pt last seen 11/15 w/ resolution of tingling in leg but now has tingling in fingertips.				Y					N	10/19/1999	10/23/1999	4	normal neruo exam, MRI of lumber spine-negative, NCV-c/w GBS	OTH	OTH			hx of prostate cancer			1						1	Guillain-Barre syndrome; Neoplasm malignant; Paraesthesia	FLU3~PFIZER\WYETH~4998242~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0133117	01/06/2000	SC	30.0	30		F	12/06/1999	Red, swollen, sore, hot (12/4/99 at 9:00pm), improved on 12/6/99.									Y	12/03/1999	12/04/1999	1		PUB	PUB	BC Pills	Head cold/sinus	Allergies-sinus	~ ()~~~In patient	SC99079	1						1	Oedema; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0145BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0133120	01/06/2000	MA	48.0	48		M	11/02/1999	Wife called stating pt was experiencing chills, fever & achiness. Pt took phone, stated he was fine & informed me he would be hanging up & did. F/u call on 11/4, pt returned call & left message that he was fine.									Y	11/01/1999	11/01/1999	0		PVT	PUB				~ ()~~~In patient		1						1	Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0107AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~15854~UNK~~RA~PNEUMO (PNEUMOVAX)~1|TD~MASS. PUB HLTH BIOL LAB~TD65~UNK~IM~LA~TD ADSORBED (TDVAX)~1	USA		Influenza
0133121	01/06/2000	NY	38.0	38		F	12/02/1999	Symptoms began on 11/22/99 w/ burning on chest & back., both legs had numbness & tingling. Tx w/ Voltaren.									N	11/16/1999	11/22/1999	6		PVT	UNK	Synthroid		hypothyroidism	~ ()~~~In patient		1						1	Back pain; Chest pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~U0103AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~U0012AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0133124	01/06/2000	OH	32.0	33		F	10/27/1999	On 10/15/99, pt recv'd flu vax. Later that night dvlped night sweats & bad dreams. Next day she had hives all over. Took Benadryl w/ relief. Hives began to fade on 3rd day in am & was gone by pm.									Y	10/15/1999	10/15/1999	0	NONE	PUB	PUB	BC pills	NONE	NONE	~ ()~~~In patient	OH99090	1						1	Abnormal dreams; Hyperhidrosis; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~0277P~3~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0133130	01/06/2000	GA	52.0	52		F	12/09/1999	Bronchitis, sinusitis, strep throat, upset stomach, burning in chest, esophageal pain, chest pain, & nausea for over 1 month. Lab work showed a dehydrating flu syndrome.				Y					N	11/09/1999	11/15/1999	6		PVT	OTH	vitamin E, Cozar	NONE	high BP, osteoarthritis, diabetes, allergic to all 'caines	~ ()~~~In patient		1						1	Bronchitis; Chest pain; Dehydration; Dyspepsia; Infection; Influenza; Nausea; Oesophagitis; Sinusitis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0133131	01/06/2000	VA	47.0	47		F	12/13/1999	Pt recv'd vax and 2 wks later called stating her arm had been sore; came in & tx w/ Aleve. Dxed w/ inflammation of rotator cuff.				Y					U	10/04/1999	10/04/1999	0		OTH	PVT		NONE		~ ()~~~In patient		1						1	Myalgia; Pain	FLU3~PFIZER\WYETH~4998227~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0133142	01/07/2000	GA	53.0	53		F	11/22/1999	Immunized 10/13/99, pt developed swelling of l/arm that evening.  10/14/99, pt had l/arm swelling, fever & chest pain. Went to clinic, BP 200/168, called ambulance, pt hospitalized in ICU.  BP under control, swelling in arm decreased.				Y	Y				Y	10/13/1999	10/14/1999	1	EKG-normal sinus rhythm,WBC-12.1,hemoglobin-13.3,platlets-288,000	PUB	PUB		NONE		~ ()~~~In patient	GA99181	1						1	Agitation; Chest pain; Hypertension; Leukocytosis; Oedema peripheral; Pyrexia	FLUX~UNKNOWN MANUFACTURER~03179P~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0042J~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0133152	01/08/2000	MI	25.0	27		F	12/17/1999	Pt felt warm, aching of joints still. Developed rash on arms & back of neck & upper abdomen. Went to ER, Dr not sure, but had inflammed ears. 11/10, vomiting,ear pressures, sweating. 11/13, Dr tx'd w/Ceclor. Now, sorethroat, tingling legs.				Y					N	10/01/1999	10/01/1999	0		PUB	PUB	NONE	NONE	NKDA	~ ()~~~In patient	MI99141	1						1	Arthralgia; Asthenia; Ear disorder; Hyperhidrosis; Paraesthesia; Pharyngitis; Rash; Vasodilatation; Vomiting	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0133159	01/08/2000	MA	43.0	43		M	11/12/1999	Stiffness, limited rom, pain greater at add & abduct limits.									Y	10/03/1999	10/03/1999	0	NONE	MIL	MIL	Not reported	NONE	Not reported			1						1	Hypertonia; Pain	FLU3~PFIZER\WYETH~4998234~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0133162	01/08/2000	GA	58.0	58		F	12/10/1999	Pt states, 2-3 hrs after vax, her L/arm started swelling from shoulder down to her fingertips & light swelling around her neck. Seen by Dr on 12/9/99 & her B/P was elevated, 180/100. As of 12/10/99, sx's gone, except for swelling of L/hand.				Y					Y	12/08/1999	12/08/1999	0	EKG-Poss Atrial enlargement, <T-wave abnormalty. Pt given Solumedrol, Benadryl & Medrol pack.	PUB	PUB	NONE	NONE	Borderline B/P, Penicillin allergy	~ ()~~~In patient	GA99180	1						1	Oedema; Pain	FLU3~PARKDALE PHARMACEUTICALS~01989P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0133165	01/08/2000	GA	47.0	47		F	12/02/1999	Pt c/o teacup size area which is very red, hard and sore to R/arm where Pneumonia shot was given.									Y	11/30/1999	12/02/1999	2		PUB	PUB	NONE	NONE	Mult Sclerosis	~ ()~~~In patient	GA99176	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~01989P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~463745~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0133184	01/10/2000	OH	27.0	27		F	01/10/2000	Numbness & tingling of toes, spread to total foot esp R side. Cramping of calf, thigh, & temp. Changes alt hot & cold.  Some numbness of R thigh. Numbness of R fingers. Generalized weakness. Suspected GBS.									Y	10/15/1999	11/13/1999	29	MS ruled out via MRI. Nero consult, neuro exam +. Blood work for Lyme disease - NL. No LP done.	PVT	PVT	Ovacon	NONE	NONE	~ ()~~~In patient		1						1	Asthenia; Guillain-Barre syndrome; Muscle spasms; Paraesthesia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0103AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0133182	01/11/2000	AL	69.0	69		M	01/07/2000	11/10/99:Pt recv'd flu vax.Following the vax, pt developed transverse myelitis & paralysis.Pt was hospitalized.					Y				U	11/10/1999				UNK	UNK					U200000009	1						1	Myelitis; Paralysis; Myelitis; Paralysis	FLU3~CONNAUGHT LABORATORIES~U0163AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0163AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0133183	01/11/2000	TX	55.0	55		F	01/10/2000	Swelling of face, itching, muscle pain (left extremity). Tx'd with Benadryl, as advised by ER when she called them, 1/9/00, early a.m. 1/9/00, Saw MD and he gave her Decadron, Clarion, Medrol dose pk prescription.				Y						01/08/2000	01/09/2000	1	NONE	PVT	PVT	Premarin, Paxel	NONE	Penicillin & Sulfa	~ ()~~~In patient		1						1	Face oedema; Myalgia; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0170AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0133197	01/11/2000	OH	38.0	38		F	01/05/2000	10.5 x 12 cm tenderness areoun injection site. 6 x 5 cm induration and redness.									N	01/03/2000				PVT	PVT		NONE	Asthma	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~CONNAUGHT LABORATORIES~U0102AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466785~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0133203	01/11/2000	MA	63.0	62		M	11/23/1999	Reaction began with in 4 hours - had resness, itchiness, swelling, severe edema, slight pain, swelling to elbow, seen next day.  Advice:elavation, rest, advil, and benadryl.  Totally resolved on 10/24/99.									Y	10/19/1999	10/19/1999	0		PUB	UNK	Lipitor	NONE	NONE	~ ()~~~In patient	MA9927	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0107AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1095H~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0133204	01/11/2000	MA	40.0	40		M	11/23/1999	Baseball size lump with redness and tenderness, hot to touch, redness all over upper arm, weakness, fatigue, elevated temperature. Advice: advil, benadryl.  Took the pt 2 weeks to recover.									Y	10/19/1999	10/20/1999	1		PUB	UNK	Flovent, ventolin	NONE	Asthma	~ ()~~~In patient	MA0001	1						1	Asthenia; Injection site hypersensitivity; Injection site mass; Injection site pain; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0107AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1095H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0133205	01/11/2000	MA	74.0	74		F	12/17/1999	Late afternoon 10/8/99, pt experienced fatigue, lethargy, anorexia, no HA, fever, muscle aches, nausea/vomiting, by 10/10 had developed a rash that was patchy and raised on legs, chest, back face, it was intensely itchy.				Y					Y	10/07/1999	10/08/1999	1	NONE	PUB	PUB	Axid, lasix, toprol,	NONE	hypertension, heartburn, mild enviornmental allergies.	Pt had prior adverse effects after flu vax, swollen arm at inject site.~ ()~~~In patient	MA0002	1						1	Asthenia; Muscle atrophy; Pruritus; Pyrexia; Rash maculo-papular; Somnolence	FLU3~CONNAUGHT LABORATORIES~U0107AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0133206	01/11/2000	MA	44.0	44		F	11/23/1999	Lt/ arm swollen like baseball - hard, hot, red, weakness of arm.  Md advised to take benadryl, advil.  Pt took meds for one week.									Y	10/19/1999	10/19/1999	0		PUB	UNK	prempro, inhalers		Allergy to dust, mold, roprovecal, cats, - asthma	~ ()~~~In patient	MA0003	1						1	Asthenia; Injection site mass; Injection site oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0107AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1095H~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0133207	01/11/2000	MA	51.0	51		M	11/24/1999	Pt's R/arm had hard area size of baseball to grapefruit.  Hot to touch, red, fever, tenderness to touch, felt weak, reaction lasted for 1 week.  Took aspirin.									Y	10/19/1999	10/19/1999	0	NONE	PUB	UNK	Vit B&E, inhalers		Asthma	~ ()~~~In patient	MA0004	1						1	Asthenia; Injection site mass; Pain; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0107AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1095H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0133210	01/11/2000	MA	65.0	65		F		Pt reports rcvd vax on10/19/99.  On 11/7/99 c/o fatigue, terrible pains in legs, upper back, lost 10 pounds and was put on prednisone.									U	10/19/1999	11/07/1999	19		PUB	PUB		NONE		~ ()~~~In patient	MA0006	1						1	Asthenia; Pain; Weight decreased	FLU3~CONNAUGHT LABORATORIES~U0106FA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0133211	01/11/2000	MA	65.0	65		F	12/06/1999	20 min post vax, pt developed redness and irritation in arm.  Seen in MD office on 10/15/99 was grossly swollen, r/arm with erythema from deltoid region down to forearm.  Given course of Cipro if symptoms continue.  Pt didn't need to take.									Y	10/12/1999	10/12/1999	0		PVT	PUB	Celebrex, coumadin, levoxyl		PCN allergy, hx of recurrent DVT	~ ()~~~In patient		1						1	Oedema; Rash; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0103AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~858742~2~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0133217	01/11/2000	SC	79.0	79		M	12/08/1999	2 hrs poxt vac, experienced stiffness and dull pain in l/arm. 12/7/99 pt expereinces elbow area swelling, red, hot to touch. 12/8/99, still felt dull pain at touch, less swollen, less red, moving arm.  12/14/99, no pain, swelling, redness.									Y	12/06/1999	12/06/1999	0		PUB	UNK	NONE	NONE	NONE	~ ()~~~In patient	SC99085	1						1	Hypertonia; Oedema; Pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0205AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1095H~2~SC~LA~PNEUMO (PNEUMOVAX)~1|TTOX~CONNAUGHT LABORATORIES~U0011AA~2~IM~LA~TETANUS TOXOID, ADSORBED (NO BRAND NAME)~1	USA		Influenza
0133220	01/11/2000	WA	46.0			F	01/06/2000	Post vac, immediately noted pain and tingling in lower arm.				Y						10/15/1999	10/15/1999	0		UNK	UNK				~ ()~~~In patient		1						1	Pain; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~4998230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0133238	01/12/2000	OH	46.0	46		F	01/04/2000	Influenza vax, site became red, itchy, swollen, warm.  Became flushed, c/o nausea, dizziness, headache.									Y	10/21/1999	10/21/1999	0		OTH	OTH	Norvasc, Synthroid, Potassium	NONE	Allergies: IVP dye, sulfa	~ ()~~~In patient		1						1	Dizziness; Headache; Injection site hypersensitivity; Injection site oedema; Nausea; Pruritus; Vasodilatation	FLU3~PFIZER\WYETH~4998236~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0133248	01/12/2000	WA	27.0	27		F	01/06/2000	Redness, swelling within 24 hrs of vax. Confirmed swelling 42 hrs later in R upper arm.				Y					U	01/04/2000	01/05/2000	1		MIL	MIL		NONE	N/A	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4998345~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HBPV~PFIZER\WYETH~1611H~1~SC~RA~HIB POLYSACCHARIDE (HIBIMUNE)~1	USA	Emergency room visit	Influenza
0133251	01/12/2000	CA	51.0	51		M	01/05/2000	Nagging pain in L/arm for over 2 mos. Pain radiates up & down arm into shoulder & neck area. Numbness in fingertips L/hand, limited mobility of L/arm due to pain. Saw Dr 12/7; tx'd w/Naproxen Sodium for 2 wks. Still exists, no dx.				Y					N	10/27/1999	11/05/1999	9	Dr could not come up w/any specific problem with his test procedures.	PUB	PUB	lisinopril 5mg/day	NONE	Mild Hypertension	~ ()~~~In patient		1						1	Hypoaesthesia; Hypokinesia; Pain; Hypoaesthesia; Hypokinesia; Neck pain; Pain	FLU3~PFIZER\WYETH~4998221~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~7258BA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4998221~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|TD~CONNAUGHT LABORATORIES~7258BA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0133260	01/12/2000		27.0	27		M	12/03/1999	At approx 22:00, 11/29/99, a rash started on neck, arms, chest and back. Pt reported to medical at 07:30, 11/30/99.				Y					Y	11/29/1999	11/29/1999	0		MIL	MIL	INH & B6	NONE	PPD Reactor, taking INH & B6 since 7/16/99			1						1	Rash	FLU3~CONNAUGHT LABORATORIES~VC168AA~1~IM~AR~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0132731	01/13/2000	CA	60.0			F	12/10/1999	Pt had flu vaccine on 11/11/99. On 11/18, pt developed dizziness with progression to ataxia.  Weakness of lower extrimeties and ptosis.  Pt was admitted to hospital.  Dx was GBS and treated with plasmapheresis.					Y	9			N	11/11/1999	11/18/1999	7	Electromyelogram	PVT	PVT	Verapamil, colace, glucosamine, gliburide	cough	diabetes mellitus, hypertension			1						2	Asthenia; Coordination abnormal; Cough; Diabetes mellitus; Dizziness; Eyelid ptosis; Guillain-Barre syndrome; Hypertension	FLU3~CONNAUGHT LABORATORIES~U0136AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0133268	01/13/2000	NV	61.0	61		F	01/06/2000	That evening, developed swelling of lt half of her head, face and eye which also extended from the left side of her neck to her collar bone. She had confusion in thinking, mispronouncing of words, insomnia & each day had terrific migraine				Y				Y	U	11/10/1999	11/10/1999	0	Nuclear MRI-neg  blood work-reportedly neg	PVT	OTH	Fosamax	NONE	UNK		0302405JAN	1						1	Face oedema; Generalised oedema; Insomnia; Migraine; Speech disorder; Thinking abnormal	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0133301	01/13/2000	VT	46.0	46		M	12/16/1999	Tingly numbness rear L sole, heal, & rear arch. Spread 1/2 rear calf, then to include entire L palm, forearm while present in leg. 1 wk later numbness receded. Present only in L foot. Ruled out GBS.									Y	10/14/1991	10/08/1999	2916	Brain MR scan normal.	PVT	UNK				~ ()~~~In patient		1						1	Paraesthesia	FLU3~CONNAUGHT LABORATORIES~U0104AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0133277	01/14/2000	OH	67.0	67		F	01/06/2000	Redness, swelling at site, warm to touch. Rash on legs & feet, hand, feet have persistent swelling. Inc muscle weakness, weight loss, tired.				Y					N	10/23/1999	10/23/1999	0	NONE	PUB	PVT		NONE	Hx of multiple health concerns.	AE at 65 in 10/1997.~ ()~~~In patient		1						1	Asthenia; Injection site hypersensitivity; Injection site oedema; Myasthenic syndrome; Rash; Vasodilatation; Weight decreased	FLU3~CONNAUGHT LABORATORIES~U0150AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0133280	01/14/2000	WA	41.0			F	01/06/2000	Patient received influenza vaccination.  Next day complained of pain in arm, severely decreased range of motion, tender @ injection site, no erythema.										11/15/1999	11/15/1999	0		OTH	UNK				~ ()~~~In patient		1						1	Hypokinesia; Injection site pain	FLU3~PFIZER\WYETH~4998230~UNK~IM A~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0133282	01/14/2000	NJ	24.0	24		M	10/29/1999	Local reaction with inflammation near injection site at 3 days post, warmth, redness.  No associated allergic reaction.										10/26/1999	10/27/1999	1		UNK	UNK	NONE					1						1	Injection site inflammation; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0133283	01/14/2000	NJ	40.0	40		M	12/04/1999	Swelling at upper arm after receiving flu shot.										12/04/1999	12/04/1999	0		MIL	UNK				~ ()~~~In patient		1						1	Injection site oedema	FLU3~CONNAUGHT LABORATORIES~U0145EA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0133286	01/14/2000	AK	52.0	52		F	11/07/1999	Pain, swollen arm, huge lump at site of vaccine. Redness from shoulder to wrist. Confusion, inability to think, feelings of coldness. A sense that I might die.  Neurological lack of coordination. Can't speak properly.				Y					U	10/28/1999	11/01/1999	4		PUB	UNK				~ ()~~~In patient	AK200009	1						1	Chills; Confusional state; Coordination abnormal; Injection site mass; Injection site oedema; Injection site pain; Speech disorder; Vasodilatation	FLU3~PFIZER\WYETH~4998209~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TTOX~CONNAUGHT LABORATORIES~00012AA~UNK~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0133291	01/14/2000	AK	33.0	33		F	09/30/1999	1 by 1 1/2 inflamed redness, hotter to the touch than the neighboring area.  Still there after 24 hours.										09/29/1999	09/29/1999	0		PUB	UNK					AK200005	1						1	Injection site hypersensitivity; Vasodilatation	FLU3~PFIZER\WYETH~4998209~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0133292	01/14/2000	AK	54.0	54		F	10/13/1999	Pt rcvd vax 10/9/99, on 10/12/99 L/upper arm had 3: x 4: erythematoma, inudration.  Pt had temp of 102.									U	10/09/1999	10/11/1999	2	NONE	OTH	OTH	Provera, Premarin	NONE	NONE	~ ()~~~In patient	AK200006	1						1	Injection site mass; Pyrexia; Rash	FLU3~PFIZER\WYETH~499822~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~UNKNOWN MANUFACTURER~459837~1~~LA~PNEUMO (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~73018A~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0133293	01/14/2000	AK	69.0	69		F	10/25/1999	Influenza Vaccine 10/12/99 pt started itching that evening, noticed rash 10/13/99 (evening) with itching spreading.										10/12/1999	10/12/1999	0		PUB	UNK	Thyroid, Premarin		No known allergies; colon ca surgery 2/98, no chemo	~ ()~~~In patient	AK200007	1						1	Pruritus; Rash	FLU3~PFIZER\WYETH~4998209~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0133295	01/14/2000	AK	23.0	23		F	11/12/1999	Pt developed rash on abdomen that started 2:00 pm on 11/11/99.  At 11:00 p.m. she noticed rash over entire body.  Pt instructed to take benadryl.  11/15/99, pt improving, she never picked up benadryl, but rash is leaving.									Y	11/09/1999	11/11/1999	2		PVT	PUB		15.3 weeks pregnant	Amoxicillin	~ ()~~~In patient	AK200010	1						1	Rash	FLU3~PFIZER\WYETH~4998209~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0133296	01/14/2000	AK	50.0	50		F	09/15/1999	Pain, swelling at inject site, l/deltoid, no fever, no abscess, no rash, adenopathy, hives.									Y	09/10/1999	09/11/1999	1		PVT	PUB				~ ()~~~In patient	AK200011	1						1	Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4998209~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0133298	01/14/2000	AK	45.0	43		F	09/24/1999	Pain, swelling, left deltoid.									Y	09/22/1999	09/23/1999	1		PUB	PUB		NONE	NONE	~ ()~~~In patient	AK200013	1						1	Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4998209~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0133302	01/14/2000	NC	69.0	69		F	01/07/2000	Pt reports 3 days post/vax, had sudden loss of hearing. Some hearing has returned to L/ear but no hearing in R/ear at all. As of 10/21/99, pt has essentially no hearing the right ear with a slight high frequency dip but otherwise fairly normal left ear.				Y					N	10/15/1999	10/18/1999	3	MRI-lunar infarcts, Carotid Artery Studies-nml, Treadmill tests-nml	PVT	PVT	Calcium, Multi-Vitamins, Prozac, Flomax	NONE	Depression			1						1	Deafness	FLU3~PFIZER\WYETH~4998275~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0133444	01/14/2000	MO	40.0	40		F	11/15/1999	Skin over r/deltoid warm to touch, tender to touch and erythema is present and 50mm of edematous skin of the deltoid area.Montored over the course of three days.  Area resolved at the end of three days.									Y	11/10/1999	11/12/1999	2		PUB	UNK	PPD					1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0167AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~LEDERLE LABORATORIES~465317~4~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0133182	01/19/2000	AL	69.0			M	01/07/2000	Pt. rcv'd. Fluzone sv 99-00 vax. on 11/10/99. He developed transverse myelitis & paralysis. Pt. was admitted to the hospital, actual date (actual date unspec.) & discharged on 1/6/00.					Y				U	11/10/1999				UNK	UNK					U2000000090	1						2	Myelitis; Paralysis; Myelitis; Paralysis	FLU3~CONNAUGHT LABORATORIES~U0163AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0163AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0133344	01/19/2000	NC	24.0	24		M	12/22/1999	Pt presented with body rash and treated with Prednisone, 60mg x 3d, 40mg x 3d, and 20mg x3d.				Y					Y	10/25/1999	11/04/1999	10	NONE	MIL	MIL	NONE	NONE	NONE	~ ()~~~In patient		1						1	Rash	FLU3~CONNAUGHT LABORATORIES~U0135AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0133346	01/19/2000	MS	67.0	67		M	12/23/1999	Was sore & swollen until last wk. Pt c/o tingling in hand & hurting to the bone at injection site. Went to Dr due to increased weakness, unsteady gait & feeling tired. Was walking 2 miles a day, now only 1/2 mile w/SOB.									U	10/28/1999	10/28/1999	0		OTH	OTH		NONE	NONE	~ ()~~~In patient	MS99054	1						1	Asthenia; Bone pain; Gait disturbance; Injection site mass; Injection site pain; Malaise; Paraesthesia; Pyrexia	FLU3~PFIZER\WYETH~4998232~7+~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0133348	01/19/2000	WA	23.0	23		F	01/10/2000	Flu shot given to employee 1/7/00. On set of hives on 1/8/00, 2:00 am. Hives have improved but still present on 1/10/00.									U	01/07/2000	01/08/2000	1		PVT	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~U0144AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0133350	01/19/2000	FL	57.0	57		F	12/16/1999	Rcv'd vax 11/22/99. 1 hr post vax, L arm became red and swollen, no hives, no itching. Symptoms dec after 2 days.									U	11/22/1999	11/22/1999	0	N/A	PUB	PVT	Progesterone	NONE STATED	Allergy to PCN, sulfa.	AE following Tetnus in pt.~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~02189P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0133353	01/19/2000	MA	69.0	69		F	12/30/1999	Started w/pain & edema, last night after shots. Swelling down past elbow 31x18cm area of erythema, edema, warm & tender in L/arm. Allergic rxn vs cellulitis vs both. Tx'd w/Keflex & Claritin.									Y	12/20/1999	12/20/1999	0	NONE	PVT	PVT	NONE	NONE	Depression	~ ()~~~In patient		1						1	Cellulitis; Injection site hypersensitivity; Injection site pain; Oedema peripheral; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~4099G010~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1095H~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~MASS. PUB HLTH BIOL LAB~TD65~UNK~IM~RA~TD ADSORBED (TDVAX)~1	USA		Influenza
0133357	01/19/2000	AZ	58.0	58		F	12/27/1999	Within t weeks after vaccine developed sub deltoid bursitis type pain in vaccination arm.									N	11/01/1999	11/15/1999	14	NONE	PVT	OTH	Inderal	NONE	Tetracycline allergy	~ ()~~~In patient		1						1	Pain	FLU3~PFIZER\WYETH~4998230~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0133358	01/19/2000	MO	49.0	49		U	12/28/1999	Onset 12/13/99, body aches, headache all over, fever 100 - 102, pains upper chest, sore throat, cough with phlegn (color?), decreased appetite.									Y	11/12/1999	12/13/1999	31	Virus Culture	OTH	PUB	thyroxin, phemphase	NONE	Demerol allergy passed out	~ ()~~~In patient		1						1	Anorexia; Chest pain; Cough; Headache; Influenza; Myalgia; Pharyngitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0163AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0133394	01/20/2000	VA	28.0			M	01/10/2000	Erythematous maculo-papular rash scattered from scalp to feet with mild periorbital edema.				Y						12/03/1999	12/05/1999	2		MIL	PUB				~ ()~~~In patient		1						1	Face oedema; Rash maculo-papular	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~~UNK~~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0133396	01/20/2000	IA	71.0	70		F	01/13/2000	Raised red hives on l/shoulder extending across the back of shoulders and to the posterior neck.  Described as very painful.  No a true dermatoform distribution.  Started one week after flu shot (10/28/99).									Y	10/14/1999	10/21/1999	7	NONE	PVT	PVT	Lotensin	NONE	NONE	~ ()~~~In patient		1						1	Pain; Urticaria	FLU3~CONNAUGHT LABORATORIES~4998283~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0133403	01/20/2000	MA				U		1 day after immunization to r/deltoid, pt developed sore r/arm, shoulder to elbow then continued pain in hips and back and both arms.													Sed rate = 40	PUB	OTH	Trazadone	NONE	Tetanus - Biaxin	~ ()~~~In patient		1						1	Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0133404	01/20/2000		43.0	43		M	12/22/1999	4 hours post vacc - headache, 24 hours post vacc - headache, fever, swelling, rash, severe itching.  48 hours post vacc - headache, swelling in elbow, forearm, itching.  72 hours post vacc. - swelling in elbow, forearm, itching.				Y					N	12/15/1999	12/15/1999	0		OTH	MIL	PPD	NONE		Knot/swelling~Anthrax (no brand name)~1~42.00~Patient|Knot/swelling~Anthrax (no brand name)~2~42.00~Patient|Knot/swelling~Anthra		1						1	Headache; Oedema peripheral; Pruritus; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0133375	01/21/2000	IN	51.0			F	01/18/2000	Pt has been on VIOXX for 1 week, received flu shot and started itching within 2 hrs on back of neck.  Raised area on back of neck, and nausea.  No reaction with previous flu shots.									U	11/03/1999	11/03/1999	0		UNK	UNK	Vioxx		NONE			1						1	Nausea; Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0133413	01/21/2000		38.0	38		F	01/06/2000	Onset of cough 4 days after flu shot. Symptoms persisted sl worsened. Airway obstruction cw asthma resulted. No prior asthma history. Recovering on meds.				Y					U	10/07/1999	10/10/1999	3	CXR normal. Allergy skin test + for mold, dust. PFT approx 75% expected.	MIL	MIL	PPD; Premarin	NONE	Multinoldular goiter			1						1	Asthma; Goitre; Lung disorder	FLU3~PFIZER\WYETH~4998234~7+~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0133416	01/24/2000	TX	18.0	18		F	01/04/2000	Bilateral rosy rash on cheeks, lasting 20min, no itching.									Y	01/21/2000	01/21/2000	0	NONE	MIL	MIL		NONE	NONE	~ ()~~~In patient		1						1	Rash	FLU3~CONNAUGHT LABORATORIES~U0167A~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~CONNAUGHT LTD.~2323AA~1~SC~~MENINGOCOCCAL (MENOMUNE-A/C)~1|TD~CONNAUGHT LABORATORIES~2507211~1~IM~~TD ADSORBED (NO BRAND NAME)~1|UNK~UNKNOWN MANUFACTURER~467041~1~IM~~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA		Influenza
0133421	01/24/2000	CA	53.0	53		F	01/11/2000	paralized vocal cord (Guillain Barre Syndrome)									N	11/03/1999	11/15/1999	12	Ct scan - normal, scope in larynx - normal	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Guillain-Barre syndrome; Vocal cord paralysis	FLU3~PFIZER\WYETH~4998252~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0133423	01/24/2000	CA	67.0	67		M		Extreme muscle weakness, inability to walk, rollover in bed, rise from a chair or bathe unassisted. Rcving. IV-gamma Globulin infusions (8) txmts. Dx with polymyositis. 60 day follow-up dated 10/16/00 states the pt is still suffering from general muscular weakness and ongoing treatment for general weakness with drugs.  Follow-up: 02/15/00 - Consent form returned by pt - sent with letter to medical center.			Y		Y	9		Y	N	10/27/1997	11/27/1997	31	muscle biopsy-confirming dx, EMG-changes in motor units	UNK	UNK	Immuran, Prednisone, Thyroxin	NONE	hypothyroidism			1						1	Abasia; Biopsy muscle abnormal; Blood product transfusion; Electromyogram abnormal; Hypokinesia; Muscular weakness; Myasthenic syndrome; Polymyositis	FLU3~CONNAUGHT LABORATORIES~7581819~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0994E~2~~~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0133431	01/24/2000	MD				U	01/17/2000	Unevaluable react: organ transplant recepient rcv'd inject of Flu Shield (1999-2000 Formula) & almost died. No further info is available as of date of this report.			Y						U				UNK	OTH	OTH	UNK	UNK	UNK		HQ0373910JAN2000	1						1	Unevaluable event	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening	Influenza
0133489	01/27/2000	NH	73.0	73		F	12/22/1999	12/9/99, pt came home from dialysis with back discomfort and weakness.  Hands and feet cold, nauseous.  Slept 3 hrs and pt felt better, but had very little movement in legs.  Could move toes and r/foot.					Y	5			Y	12/08/1999	12/09/1999	1	CT scan- no changes, MRI and X-ray - normal	OTH	PUB	Zestril, Dilantin, Imdur, Lasix, Pepsid	None	Benign brain tumor, kidney failure, heart disease, high blood pressure	~ ()~~~In patient	NH9926	1						1	Asthenia; Breast cancer; Cardiovascular disorder; Chills; Hypertension; Hypokinesia; Nausea; Neoplasm; Pain; Renal failure	FLU3~MEDEVA PHARMA, LTD.~33739KA~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0133533	01/28/2000	WI	5.0	5		F	01/19/2000	Severe asthma attacks, increasing asthma and eczema on 1/15/00. eczema breaking out prior to severe asthma attack.  Started on Prednisone, Benadryl (childrens), albuterol nebulizer and oxygen as needed.			Y	Y					N	01/13/2000	01/17/2000	4		PUB	PUB	albuterol	NONE	Asthma, eczema, allergy to antibiotics	~ ()~~~In patient		1						1	Asthma; Eczema	FLU3~PFIZER\WYETH~4998254~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|VARCEL~MERCK & CO. INC.~0731J~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Life Threatening	Influenza
0133534	01/28/2000	SC	7.0	7		M	12/09/1999	Recv'd Pneumovax on 11/2/99.Within 12 hrs began to dvlp fever,arm soreness,& redness around inject site.Within 24-36 hrs began to dvlp cellulitis of lt deltoid area of shoulders & vomiting. Ultimately, rqrd 5 IV antibiotics to tx in hosp.					Y	5			Y	11/02/1999	11/03/1999	1	WBC-17,000; CXR-lungs clear; blood culture-?	PVT	PVT	Asthma meds	NONE	asthma,pneumonia	~ ()~~~In patient		1						1	Asthma; Cellulitis; Injection site hypersensitivity; Injection site pain; Leukocytosis; Pneumonia; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0132AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~7291H~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0133538	01/29/2000	CA	51.0	51		F	01/20/2000	Throat tightness, a MD reported that she received an injection of Flu Shield (98-99) form. In 5 mins she developed throat tightness, hives, nausea, dizziness and was treated in ER. The sx's reoccurred hours later.				Y					Y	10/19/1998	10/19/1998	0	UNK	PVT	OTH	NONE	NONE	Hypersensitivity		4796105NOV	1						1	Laryngospasm; Nausea; Urticaria; Vertigo	FLU3~PFIZER\WYETH~~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0133539	01/29/2000	FL	71.0	71		M	01/18/2000	Myasthenia gravis aggravated, a 71 year old MD reported he received an injection of Flu Shield(99-00). Two weeks later he developed exacerbation of Myesthenia Gravis manifested by muscle weakness.  He was hospitalized.					Y	5			Y	11/12/1999	11/26/1999	14	UNK	OTH	OTH	Mestinon, Prednisone	UNK	Myasthenia gravis		0479014JAN	1						1	Condition aggravated; Myasthenic syndrome	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0133540	01/29/2000	IN	51.0			M	01/18/2000	Pt has been on Vioxx for 1 week. Received flu shot and started itching within 2 hours on back of neck. Pt also has raised areas on back of neck and nausea.							Y		U	11/03/1999	11/03/1999	0		OTH	OTH	Vioxx	NONE		~ ()~~~In patient		1						1	Nausea; Pruritus; Rash maculo-papular	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0133041	01/31/2000	CA	57.0	57		F	12/09/1999	Reportedly pt dvlped symptoms eventually dxed as Guillian Barre Syndrome-starting a few days after vax.			Y		Y				U	10/26/1999	10/28/1999	2		PUB	PUB				~ ()~~~In patient	990166	1						2	Abdominal pain; Coordination abnormal; Guillain-Barre syndrome; Paraesthesia; Guillain-Barre syndrome	FLU3~MEDEVA PHARMA, LTD.~E27979HA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~E27979HA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Life Threatening,Hospitalisation	Influenza
0133591	01/31/2000	CA	51.0	51		M	12/29/1999	Weakness & fatigue mainly in leg muscles & to a lesser extent in arm muscles-worse in am & with physical activity. Dx R/O Guillain Barre Syndrome. Pt experienced a poor appetite and nausea.  Follow-up: 02/15/00 - Consent form returned by pt - mailed with letter to hospital.					Y	2			Y	11/03/1999	11/03/1999	0	WBC-12300, Hemoglobin-17, hematocrit-50, Sodium-142, potassium-4.3, glucose-89, BUN-10, Creatinine-1,	UNK	UNK	NONE	NONE	NONE		CA990162	1						1	Asthenia; Decreased appetite; Fatigue; Nausea	FLU3~PFIZER\WYETH~4998252~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0133074	02/01/2000		44.0	44		F	11/22/1999	On 11/20/99, pt reported w/4cm area, LUA, mild erythema & tenderness. No induration, no significant swelling. Rx: Tylenol & ice to LUA PRN.				Y					Y	11/12/1999	11/20/1999	8	NONE	MIL	MIL		NONE	NONE			1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4998234~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~LEDERLE LABORATORIES~466025~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0133174	02/01/2000	MD	30.0	29		M	12/28/1999	C/o N/V, dry mouth, low grade fever, decreased appetite, abdominal pain & cramps. Local burning & pain, lump at injection site. Tx'd w/Tylenol only.									Y	05/12/1999	05/12/1999	0	NONE	MIL	MIL	NONE	NONE	Allergic to Percocet	~ ()~~~In patient		1						1	Abdominal pain; Anorexia; Dry mouth; Injection site mass; Injection site pain; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~1~IM~~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~1~IM~~HEP A (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~1~SC~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0133281	02/01/2000	WA	46.0			F	01/06/2000	Immediately after vax, pt noticed pain & tingling in lower arm. Was seen in ER & told probable injection to bursa. Pt received physical therapy.				Y					U	10/15/1999	10/15/1999	0		OTH	OTH				~ ()~~~In patient		1						1	Pain; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~4998230~UNK~IM A~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0133294	02/01/2000	AK	59.0	59		F	11/24/1999	C/o dull ache in L/deltoid area, off & on since receiving vax. Soreness started on 10/15. Denies swelling, redness in area at any time. Soreness goes away & reappears w/movement of arm, like when cleaning around home.									N	10/15/1999	10/15/1999	0		PUB	OTH		NONE	NONE	Sore arm for 2 yrs with getting Flu vaccine.~ ()~~~In patient	AK200008	1						1	Injection site pain	FLU3~PFIZER\WYETH~499820~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0133472	02/01/2000	VA	51.0	51		F	12/01/1999	Pt complains of swelling and redness to right arm.				Y					Y	11/24/1999	11/25/1999	1		OTH	OTH				~ ()~~~In patient		1						1	Oedema peripheral; Vasodilatation	FLU3~PFIZER\WYETH~4998243~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~1483J~2~SC~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0133494	02/01/2000	MD	54.0			M	01/11/2000	Headache, stiff neck, nausea for 3 days following anthrax doses 1,2,3.									U	10/16/1999	10/18/1999	2	CXR, pending	MIL	MIL	Atenolol					1						1	Headache; Nausea; Nuchal rigidity	ANTH~EMERGENT BIOSOLUTIONS~FAV066~3~~~ANTHRAX (BIOTHRAX)~1|FLU3~CONNAUGHT LABORATORIES~0135AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0133496	02/01/2000	KY	47.0	46		F	01/20/2000	C/O arm pain beginning after injection and continuing even now 2 1/2 months later.  Pain has moved from injection site to just below elbow. Has taken meds but no improvment.  Will see orthopedic MD this week. Pain constant, worse at night.				Y					N	11/09/1999	11/09/1999	0		PUB	PUB		NONE	PNC	~ ()~~~In patient	KY2000004	1						1	Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~02289P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0133505	02/01/2000	WV	4.0	4		M	01/18/2000	Cough, congestion, fever.									Y	10/14/1999	01/12/2000	90	Nasal viral panel for influenza A&B	PVT	PVT		NONE	Arnold-Chiari malformation, V-P Shunt Hydrocephalus, sulfa allergy.	~ ()~~~In patient		1						1	Cough; Pyrexia; Rhinitis	FLU3~PFIZER\WYETH~4998240~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0133509	02/01/2000	SC	59.0	59		F	01/13/2000	Urticaria-2 cm wheals at site of each injection & below each site. L/arm very sore & painful to raise. MD recommended no repeat of these vaccines in the future.									Y	12/08/1999	12/09/1999	1	NONE	PUB	OTH	Vasotec, Nolvadex, Prilosec, Vitamin-E & Vitamim-D	NONE	Hx/Breast CA, Mastectomy, Osteoporosis, Raynaud's	~ ()~~~In patient	SC00001	1						1	Hypokinesia; Injection site hypersensitivity; Injection site pain	FLU3~CONNAUGHT LABORATORIES~U0205AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1095H~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0133514	02/01/2000	MI	51.0	51		F	01/19/2000	6 hrs after vax; start of head cold; sore injection area. Fever 103 x 2 days, nausea throughout, skin hurt shooting pain from arm to chest to spine, muscle ache, dizzy; 3 day bilateral hip/leg nerve pain. DR rx'd by phone: Flumadine x2d									U	01/11/2000	01/11/2000	0	NONE	PUB	PVT	Premarin, Imitrex, Fiorinal prn	NONE	Wheat, turkey, tuna, grass, sulfa	~ ()~~~In patient		1						1	Dizziness; Injection site pain; Myalgia; Nausea; Neuralgia; Pyrexia	FLU3~PFIZER\WYETH~4998254~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0133519	02/01/2000	KY	77.0	77		F	12/23/1999	Dr treated pt for shingles in her eyes. Shingles had almost cleared & pt received Flu shot & shingles exacerbated again. Dr told family he has 3 pts this has occurred with.									Y	10/22/1999	10/24/1999	2		PUB	PUB	B/P med (Premavil), Ocuflox eye drops, FML	Had been treated for Shingles	Shingles	~ ()~~~In patient	KY2000002	1						1	Herpes zoster; Infection	FLU3~PARKDALE PHARMACEUTICALS~02979P~7+~IM A~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0133549	02/01/2000	TX	56.0	56		F	10/30/1998	Cellulitis, bright red, itching, fever, rt deltoid.  Hands bilaterally numb up to her neck.  Still has problems under arm and around elbows itching and minimal swelling.				Y					N	10/16/1998	10/17/1998	1		PUB	PVT		NONE		~ ()~~~In patient		1						1	Cellulitis; Injection site hypersensitivity; Oedema; Paraesthesia; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975800~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0906E~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0133552	02/01/2000	MO	65.0	64		F	12/28/1999	Pt called health dept and c/o wasting away of upper arm from Td received last year.  Instructed pt to see her own MD for evaluation and call back with MD's report. Per HCP follow up report- Patient called health dept and complained of wasting away of upper arm from Td received last year. Received flu vaccine same day but patient states the arm into which Td was administered in the arm bothering her. Instructed patient to see her own doctor for evaluation and call back with doctor's report.									U	10/12/1998	06/01/1999	232		UNK	UNK	Asthma and allergy medications (not specific)		Asthma, allergy to milk, peanuts, wheat		MO2000002	1						1	Cachexia	FLU3~CONNAUGHT LABORATORIES~0981800~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~00967100~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0133554	02/01/2000	MS	53.0	53		F	01/23/2000	Light-headed, few seconds. Red & swollen arm, three wks. No treatment by Dr.									Y	10/18/1999	10/21/1999	3	NONE	PVT	PVT	Provera, Premarin	NONE	NONE	~ ()~~~In patient		1						1	Dizziness; Oedema; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0133555	02/01/2000	OK	58.0	58		M	12/28/1999	He received 2 shots in R/deltoid. Today he is c/o muscle spasms & pain in that shoulder since he has received the injections.									Y	12/21/1999	12/21/1999	0		PUB	PUB	NONE	NONE	NKDA	~ ()~~~In patient	OK9967	1						1	Hypertonia; Pain	FLU3~PARKDALE PHARMACEUTICALS~02089P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~UNKNOWN MANUFACTURER~1611H~1~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0133562	02/01/2000	OH	47.0	47		M	01/16/2000	Behavior change, severely tense, irritable, depressed, problem breathing, weakness, fast heart beat, muscle aches, hives. No treatment meds received. Conditions lasted 2 days.									Y	01/14/2000	01/14/2000	0		PVT	OTH	Ambien			~ ()~~~In patient		1						1	Agitation; Asthenia; Depression; Dyspnoea; Myalgia; Nervousness; Personality disorder; Tachycardia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0133567	02/01/2000	NY	14.0	14		F	01/20/2000	Local reaction, redness, itching, rash, area warm to touch.									U	01/18/2000	01/19/2000	1		OTH	OTH		NONE	NONE	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0108BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0133570	02/01/2000	CA	58.0	57		M	01/17/2000	12/21/99, presented w/lump on L/deltoid from Flu shot received 10/21/99. On 1/14/00, recheck of arm shows increased size & tenderness. I & D of sterile Abscess done w/wick placement. On 1/17/00, replaced wick. To return in 2 days to check				Y					Y	10/21/1999	12/21/1999	61		PVT	PUB	UNK	NONE	NONE	~ ()~~~In patient		1						1	Injection site abscess	FLU3~PFIZER\WYETH~4998216~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0133582	02/01/2000	NY	27.0	27		F	01/17/2000	Redness, swelling & very warm to touch, about 2  in diameter. Began immediately & lasted 3-4 wks w/less severity. Muscles in arm & chest sore for 1 1/2 wks, gradually disappearing. Dr said adverse reacton/infection.				Y					Y	11/18/1999	11/18/1999	0		PUB	PUB	Nortriptylene, prozac & Atenelop	NONE	MVP, High B/P, Depression	~ ()~~~In patient		1						1	Chest pain; Injection site hypersensitivity; Injection site oedema; Pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0133583	02/01/2000	WI	45.0	45		F	01/18/2000	Approximately, 3:00 pm, 1/14/00, developed swelling & itching in hands, puffy face, tonge swollen, rash on abdomen & sick to stomach. Lasted approximately, 1 hr.									Y	01/12/2000	01/14/2000	2		PUB	PUB				~ ()~~~In patient		1						1	Dyspepsia; Face oedema; Oedema peripheral; Pruritus; Rash; Tongue oedema	FLU3~PARKDALE PHARMACEUTICALS~02089P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0133609	02/01/2000	PA	68.0	68		F	11/04/1999	My head felt funny like I might fall out of my chair, within 5 min after vax. After being home, pt experienced aching in extremities & by early evening, temp was 101.									Y	10/12/1999	10/12/1999	0		PUB	OTH				~ ()~~~In patient		1						1	Coordination abnormal; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0133613	02/02/2000	MD	72.0	72		F	01/24/2000	B/P prior to influenza vaccine 150/98 after vaccine 210/110				Y					Y	11/09/1999	11/09/1999	0		PVT	PVT	NONE	Borderline HTN for 5 years		~ ()~~~In patient		1						1	Hypertension	FLU3~CONNAUGHT LABORATORIES~U0109BA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0133618	02/02/2000	CA	57.0	57		F	12/22/1999	Dx of nephrosis following vax. Is resolving.				Y					U	11/01/1999	11/05/1999	4	Kidney biopsy	PUB	PVT	Progesterone cream, vitamins, Albuteral inhalor prn	NONE	Hay fever, mild asthma			1						1	Nephrotic syndrome	FLU3~MEDEVA PHARMA, LTD.~E30889KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0133644	02/02/2000	UT	49.0	49		F	01/19/2000	Instant onset pneumonia like cough, breathing labored, heavy chest, rapid heart rate, itching. Developed severe strep throat by 1/12/2000 and continual headaches.				Y					N	01/10/2000	01/10/2000	0		PUB	PVT	Dioxx, Wellbutrin, Zoloft, Estrace, Prevacid	NONE	Depression, migrane, ulcer cothritis, sensitive to erythromycin	~ ()~~~In patient		1						1	Chest pain; Cough; Dyspnoea; Headache; Infection; Pruritus; Tachycardia	FLU3~PARKDALE PHARMACEUTICALS~02289P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0133653	02/03/2000	GA	62.0	62		F	01/22/2000	Came down with full blown case of flu: cough, headache, chest hurting, ears ringing, dizzy, achy, fever.									Y	01/10/2000	01/11/2000	1		PUB	PVT		NONE		~ ()~~~In patient		1						1	Chest pain; Cough; Dizziness; Headache; Influenza; Myalgia; Pyrexia; Tinnitus	FLU3~CONNAUGHT LABORATORIES~U0166AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0133654	02/03/2000	CO	39.0	39		M	01/19/2000	Pt describes flu sx's (severe) since immunization on 12/15/99. Was not seen until 1/14/00 & diagnosed with viral syndrome. No evidence of allergic reaction.				Y					U	12/15/1999	12/15/1999	0		MIL	OTH				~ ()~~~In patient		1						1	Infection; Influenza	FLU3~PFIZER\WYETH~4998234~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0133656	02/03/2000	FL	43.0	43		M	01/23/2000	Fever, started @ 2:30 a.m. - 1/15/00 ended at 5:00 pm 1/15/00.									Y	01/14/2000	01/15/2000	1		PUB	PVT		NONE	NONE	~ ()~~~In patient		1						1	Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0133663	02/03/2000	WA	71.0	71		M	10/28/1999	Syncope episode after bowel movement.  BP 88/40, severe diaphoresis, dizziness, brief loss of consciousness, no pain or paresis noted. 2 nitrogen tabs administered after return to bed. No sequelae from episode.				Y					Y	10/26/1999	10/27/1999	1		PUB	PUB	Ticlopidine, Prelosin, Nitriglycerine, Simcastatin	Chronic diarrhea	Hx of cancer esophagus, hypertension, coronary artery disease		WA991607	1						1	Dizziness; Hyperhidrosis; Hypotension; Syncope	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0133664	02/03/2000	AL	43.0	43		M	01/19/2000	Awakened unable to breath, 1-2 min. Occured several times per night for 3-4 wks. Occurrence reduced to once/mo or so. Saw 2 throat drs, but was never diagnosed with illness.60 day follow-up received on 09/27/00 states the pt has breathing difficulty. The inability to breathe for 1 minute or so. The pt is able to breathe out, but can't breathe in.			Y						N	10/10/1976	11/10/1976	31		UNK	UNK	NONE	NONE	NONE			1						1	Dyspnoea	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0133665	02/03/2000	AL	13.0	13		F	01/27/2000	Hives onset 2 hours post vaccination.  Tx with Benadryl and Prednisone.									N	10/31/1999	11/01/1999	1		PVT	UNK	NONE	NONE	NONE	~ ()~~~In patient	MO2000003	1						1	Myelitis; Paralysis; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0163AA~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~10525~2~IM~RA~HEP B (RECOMBIVAX HB)~1	USA		Influenza
0133673	02/03/2000	WA	42.0	42		F	11/22/1999	11/22, woke up aching at site, under L/arm & inner aspect of L/arm. Visable swelling & tight. Swollen lymph nodes, painful to touch. Referred to local medical care if no improvement.									U	11/21/1999	11/22/1999	1		OTH	PVT		NONE	NONE	~ ()~~~In patient	WA991621	1						1	Injection site oedema; Injection site pain; Lymphadenopathy	FLU3~PARKDALE PHARMACEUTICALS~02879O~4~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0133675	02/03/2000	WA	62.0	62		F	10/26/1999	Vaccine last wed 10/20/99, below site, itchy welt, l/arm, bright red.  After 11am became warm to touch.  Itching on 10/24 and redness continuing on 10/25.  Reaction to TD										10/20/1999	10/24/1999	4	NONE	PUB	UNK	NONE	NONE	NONEwa		WA991019	1						1	Injection site reaction; Pruritus; Urticaria; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02979P~6~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0133676	02/03/2000	WA	57.0	57		F	10/14/1999	Back aching, taking Tylenol, r/arm f/u, no redness, felt like real bad bruise, but no discolor, feels warm to touch, very slight swelling, no pain @ time of inject, weak and dizziness.										10/13/1999	10/14/1999	1		PUB	UNK	NONE	UTI	Slight kidney infection		WA991618	1						1	Asthenia; Back pain; Dizziness; Oedema; Pain; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02979P~2~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~CONNAUGHT LABORATORIES~7302BA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0133677	02/03/2000	WA	48.0	48		F	11/12/1999	R/arm tenderness and erythema on site of vaccine injection, which developed the next day. Erythema increased day after. No fever. Size 18cm x 10cm. Tx:Benadryl.									U	11/10/1999	11/10/1999	0		PUB	PVT	Prozac, Klonopin, Premarin, Albuterol, Allegra	NONE	Depression, OCD, Asthma	~ ()~~~In patient	WA991615	1						1	Injection site hypersensitivity; Injection site pain	FLU3~CONNAUGHT LABORATORIES~U0094AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~454383~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0133678	02/03/2000	WA	42.0	42		F	11/15/1999	11/11/99, 6:00 am, felt icky, arm swollen & red, nauseated, ? fever, chest congested. Has needed inhaler & nebulizer more often the last few days. States feels worse today.									U	11/10/1999	11/11/1999	1	NONE	PUB	OTH	Albuterol nebulizer-PRN, Flovent inhaler-BID	NONE	Asthma	~ ()~~~In patient	WA991614	1						1	Lung disorder; Malaise; Nausea; Oedema; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~02289P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0133679	02/03/2000	WA	76.0	76		F	11/15/1999	Awoke with stabbing, severe sore throat, runny nose. No fever. Next day better but felt exhausted & breathless for 1 wk. Worried about heart. Went to Dr & was told sx's (no local reaction at site of injection). Has heart text set for today.									U	11/02/1999	11/02/1999	0	NONE	PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient	WA991613	1						1	Asthenia; Dyspnoea; Pharyngitis; Rhinitis	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0133680	02/03/2000	WA	34.0	34		F	11/08/1999	Severe redness and swelling at site of injection.  Tx - Augmentin				Y					U	11/05/1999	11/05/1999	0		PUB	UNK		NONE	Insulin dependent diabetic	~ ()~~~In patient	WA991612	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PARKDALE PHARMACEUTICALS~02979P~7+~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0133681	02/03/2000	WA	57.0	57		F	10/20/1999	Client received vaccine on 10/19/99, same night face was blotchy, felt poorly, eyes started swelling shut.  Next day eyes were comoletely swollen shut.  Visit made to MD.				Y					Y	10/19/1999	10/19/1999	0		OTH	OTH		NONE		~ ()~~~In patient	WA991611	1						1	Face oedema; Malaise; Rash maculo-papular	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0133687	02/03/2000	CA	30.0	30		F	01/20/2000	C/O diarrhea and cold sweats for 2-3 hours following injection.									Y	10/15/1999	10/15/1999	0	NONE	OTH	PVT	Plaquinil, chromium picolinate and selenium	NONE	Lupus (SLE)	~ ()~~~In patient		1						1	Diarrhoea; Hyperhidrosis	FLU3~CONNAUGHT LABORATORIES~210067AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0133710	02/03/2000	SC	46.0	46		F	01/26/2000	Ankles painful & swelling, wrists painful, knees painful.									U	01/12/2000	01/17/2000	5	CBC, Chem 12, Rheumatoid Factor-all normal   ^TSH-8.2	OTH	OTH	Allegra, Allegra D, Baby Asa, Stool softener, Vit-E			~ ()~~~In patient		1						1	Arthralgia; Hyperthyroidism; Osteoarthritis	FLU3~PARKDALE PHARMACEUTICALS~02189P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0133718	02/03/2000	MO	54.0	54		U	01/15/2000	Broke out in hives, eyes swollen, feet swollen, nausea and vomiting, chills, temp, skin burning and itching.Pt was hospitalized.Pt was tx w/ fluids and a low dose of steriods.					Y	3			Y	10/22/1999	10/24/1999	2	Blood c&s, cse, cmps, Chest x-ray, EKG, WBC-elevated	OTH	OTH				~ ()~~~In patient		1						1	Face oedema; Leukocytosis; Oedema peripheral; Pain; Pruritus; Pyrexia; Urticaria; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0156AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0133722	02/03/2000	CO	80.0			M	01/15/2000										U		11/16/1999			OTH	OTH				~ ()~~~In patient		1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0133731	02/03/2000	KS	39.0	39		F	12/06/1999	Same day post vax, pt felt ill. R arm red, hot to touch, swollen. Client was S&B. Dr. state had reaction to Pneumonia shot.									Y	10/18/1999	10/18/1999	0		OTH	PVT		NONE	NONE		KS99041	1						1	Injection site hypersensitivity; Injection site oedema; Malaise; Vasodilatation	FLU3~PFIZER\WYETH~4998219~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~454380~1~IM~RA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~U0010AA~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0133736	02/03/2000	KS	73.0	73		F	01/13/2000	L/arm sore where shot was given (up to 5 weeks after vaccine was given).									Y	12/01/1999	12/01/1999	0		PUB	PUB		NONE	NONE	~ ()~~~In patient		1						1	Injection site pain	FLU3~PFIZER\WYETH~4998270~7+~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~00445~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0133800	02/03/2000	WY	37.0	37		M	01/31/2000	6 x 8cm tender red area L/tricep. Pt describes elevated temp to 103 at home, responded to Ibuprofen. Ice to injection site. Claritin 10mg x 7d. Vague SOB sx's but transient, resolved.				Y					Y	01/19/2000	01/19/2000	0		PUB	OTH	Baclofen, 10mg tid	NONE	Primary Lateral Sclerosis	~ ()~~~In patient		1						2	Dyspnoea; Injection site hypersensitivity; Injection site pain; Pyrexia; Dyspnoea; Injection site hypersensitivity; Injection site pain; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~02979~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~0045J~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~PARKDALE PHARMACEUTICALS~02979P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~MERCK & CO. INC.~0045J~1~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0133643	02/04/2000	WA	24.0	24		F	11/17/1999	Injection 3:34, at 3:40 - tingling, feel funny, 3:45 - rash, nausea, feels bad, 3:50 - hot, itchy, shaky, 4:00 - went to hospital. Treated with oral and IV Benadryl. ER physician felt the patients reaction was due to the diptheria part of her vax.				Y					Y	11/10/1999	11/10/1999	0		PUB	PUB	Paxil, synthroid, birth control		Carries epipen for past anaphalactic response to latte with nutmegwa		WA991617	1						1	Malaise; Nausea; Paraesthesia; Pruritus; Rash; Tremor; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02289P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEPA~SMITHKLINE BEECHAM~615A4~2~IM~LA~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0926J~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TD~CONNAUGHT LABORATORIES~7301BA~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0133645	02/04/2000	KS	36.0	36		F	11/09/1999	Difficulty breathing, heart racing, throat and mouth dry, lips, and fingers numb, hives.  Had stomach flu symptoms.				Y					Y	11/08/1999	11/08/1999	0	NONE	PUB	PUB	Synthroid, Pepsid	NONE	Sulfa, thyroid disease		KS99035	1						1	Dry mouth; Dyspnoea; Gastrointestinal disorder; Paraesthesia; Tachycardia; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~02289P~7+~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0133744	02/04/2000	DE	43.0	43		M	01/31/2000	12/8/99, pt received Flu vaccine and Anthrax vaccine.  Pt was hospitalized on 1/1/00 to rule out GBS. Dx is confirmed positive for GBS.  Patient is still hospitalized and undergoing treatment. A 15-day follow up report received 5/9/2001 adds: Pt,  43 year old male, received the 5th dose of Anthrax vaccine (lot #FAV024) on 12/08/1999, and on 01/01/2000 experienced Guillain Barre syndrome. No relevant medical history was reported. The pt was hospitalized for Guillain Barre syndrome. He had a lengthy disease course (specifics are unknown) and made a full recovery.			Y	Y	Y	30			Y	12/08/1999	01/01/2000	24	Test for GBS-Positive	MIL	MIL	NONE	NONE	NONE		BIS000710	1						1	Guillain-Barre syndrome; Guillain-Barre syndrome	ANTH~EMERGENT BIOSOLUTIONS~FAV024~5~SC~~ANTHRAX (BIOTHRAX)~1|FLU3~CONNAUGHT LABORATORIES~U0168AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|ANTH~MICHIGAN DEPT PUB HLTH~FAV024~5~SC~~ANTHRAX (NO BRAND NAME)~2|FLU3~CONNAUGHT LABORATORIES~U0168AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0133052	02/06/2000	CA	77.0	76		F	10/12/1999	Pt R/arm became swollen from shoulder to wrist, was red, hot, lasting almost 1 wk. w/fever. Consulted w/PMD, who advised continuing to observe & come in if > problems. On 10/12, arm still slightly swollen & red.									Y	10/05/1999	10/05/1999	0	NONE	UNK	UNK		NONE	Dementia		CA990153	1						1	Oedema peripheral; Pyrexia; Vasodilatation	FLU3~PFIZER\WYETH~4998216~UNK~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|PPV~MERCK & CO. INC.~459042~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~U00618A~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0133055	02/06/2000	CA	63.0	63		F	12/13/1999	Started having chills, the evening after vax. Pt had elevated temp of 101, cough & lungs felt congested. Pt went to urgent care on 12/8/99 & was given an antibiotic injection & Rx for oral antibiotics.				Y					Y	12/03/1999	12/03/1999	0	NONE	PUB	PUB	Norvac, Zistral, Premarin	NONE	Hypertension		CA990157	1						1	Chills; Cough; Lung disorder	FLU3~MEDEVA PHARMA, LTD.~E33609KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0133056	02/06/2000	CA	68.0	68		M	12/13/1999	On 12/5/99, started having chills, heaviness in chest, fever 101 & cough. Went to urgent care & received an antibiotic injection & Rx for oral antibiotic. Now feels better but still is not 100%.				Y					Y	12/03/1999	12/05/1999	2	NONE	PUB	PUB	Gluterol	NONE	Diabetic		CA990158	1						1	Chest pain; Chills; Cough; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E33609KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0133062	02/06/2000	VA	75.0	75		M	12/03/1999	Chills, increasing rapidly for a couple hrs then fever building to well over 100F. A reading after aspirin, was 102F. This followed by nausea. ER gave Phenergan. Was in ER for 3 hrs.				Y					Y	11/23/1999	11/23/1999	0		PUB	OTH		NONE	NONE	~ ()~~~In patient		1						1	Nausea; Pyrexia; Chills; Nausea; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0110AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~456690~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1|FLU3~CONNAUGHT LABORATORIES~U0110AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~456690~1~IM~RA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0132448	02/07/2000	GA	13.0	13		M	10/28/1999	Flu -given L/DM-/IM. C/O of L arm hurting. Red area at site of inject. Sleeplessness. LDM red, feveral, 57cm & 75 cm.				Y					Y	10/26/1999	10/27/1999	1	NONE	PUB	PUB		NONE	Alsone allergy	~ ()~~~In patient	GA99159	1						1	Injection site hypersensitivity; Injection site pain; Insomnia; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02089P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0133646	02/07/2000	MO	30.0	30		F	01/25/2000	Painful sensory neuropathy, burning paresthesias, skin flaring.  Prickly sensation to extremities. Generalized fatigue, occipital headache.				Y					N	11/19/1999	11/26/1999	7		PVT	OTH	Depo Provera, Allegra	NONE	Hayfever, penicillin allergy	~ ()~~~In patient		1						1	Headache; Malaise; Neuropathy; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~U0163AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0133762	02/07/2000	TX	52.0	52		F	12/23/1999	Within 3 days of vax, had swelling, redness & itching around site of injection & it felt warm to touch. Redness was size of lemon toward medial part of arm. These sxs lasted approx 2 wks. Still itches & has dry, flaky skin at site now.									Y	11/17/1999	11/20/1999	3	NONE	PUB	PUB	Ziac, Norvasc, Prilosec	NONE	Sulfa & other antibiotics (don't know name)	Pt had itching & rash at age 50 with Pnemo vaccube.~ ()~~~In patient	99TX273	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0165AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0133764	02/07/2000	TX	60.0	60		M	12/29/1999	2 days post/vax, couldn't lift arm to brush teeth. Within 1 wk, had difficulty lifting both arms. Recurring every 2-3 days. Tylenol or Advil to relieve pain. Pt referred to Dr. Pt was given cortisone shot & told to come back if not better				Y					U	11/17/1999	11/20/1999	3		PUB	PUB	1 aspirin daily	NONE	NONE	~ ()~~~In patient	00TX002	1						1	Hypokinesia; Pain; Hypokinesia; Pain	FLU3~CONNAUGHT LABORATORIES~U0165AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0165AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0133769	02/07/2000	TX	30.0	30		F	11/02/1999	Took vaccine 8:30am-s/s started 10:00am with sore arm. By 10:00pm, arm was aching, chills, then sweating. By next morning, was ok.									Y	10/29/1999	10/29/1999	0	NONE	OTH	PUB	Thyroid med/Hormone	NONE	Thyroid problems	~ ()~~~In patient	99TX257	1						1	Chills; Hyperhidrosis; Pain	FLU3~CONNAUGHT LABORATORIES~U0165AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0133781	02/08/2000	PA	68.0			F	02/04/2000	One week post vaccination, pt developed shortness of breath and a cough.  Pt was hospitalized with pneumonia.  Pt was in ICU for 1 week and tx with antibiotics. Pt was discharged on steroids and subsequently recovered. Patient in her late 60's who on 25-OCT-1999 was vaccinated with one dose of PNEUMOVAX. Concomitant therapy included one dose of FLUSHIELD administered IM. She was intubated for one week.				Y	Y				Y	10/25/1999	11/01/1999	7	Bronchoscopy,neg	OTH	OTH			Unknown		WAES00012685	1						1	Cough; Dyspnoea; Pneumonia	FLU3~PFIZER\WYETH~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~456690~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0133782	02/08/2000	NE	8.0			M	02/04/2000	Pt has recurrent febrile infections of unknown origin.  Different multiple antibiotic therapies for fevers; hospitalization three times for fever and hematemesis as an infant. Pain in leg, red rash below inject site.  See comments. Information has been received from a registered nurse concerning an 8-year-old male patient with a history of immunodeficeincy not yet verified, cdiff. multiple antiobiotic therapyies for fevers, hospitalization times three for fever and homemesis as an infant, normal growth and development at this point with past speech therapy who on 15-NOV-1999 was vaccinated with PNEUMOVAX (lot number: 630097/0045J) in the thigh. On 16-NOV-1999, the patient had a fever of 105.5F and severe pain in the left leg where the PNEUMOVAX was administered. The patient was seen by a physician on 17-NOV-1999 and would not bear weight on the left leg because of pain. The injection site did not look affected, however, 3 cm below the injection site a small red rash had begun to form. The physician felt the patient was having a local reaction but because of this history of fevers, the patient was hospitalized. He had a WBC of 16, 000. Sed rate of 50, and a C-reactive protein of 26. He was admitted for antibiotics and what might be developing cellulitis. The patient never had a positive bacterial growth from the site or from his blood. He completely recovered and was discharged by 20-NOV-1999. Two additional patients (WAES #00020066 and #00020074) had similar experience following exposure to PNEUMOVAX. Additional information has been requested.				Y	Y	4			Y	11/15/1999	11/15/1999	0	Blood culture, 11/17/99, negative bacterial growth; body temp, 11/16/99, 105.5F; erythrocyte, 11/17/99, 50; serum c protein, 11/17/99, 26; WBC count, 11/17/99, 16.00	UNK	UNK			antibiotic therapy and fever	Pt has had similar experiences following pneumonococcal vaccine.~ ()~~0.00~Patient	WAES00012841	1						1	Blood culture; Body temperature increased; Cellulitis; Clostridial infection; Erythema; Febrile infection; Haematemesis; Immunodeficiency; Injection site pain; Local reaction; Pain in extremity; Pyrexia; Rash; Red blood cell sedimentation rate increased; Speech rehabilitation; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0045J~UNK~UN~LL~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0133800	02/08/2000	WY	37.0	37		M	01/31/2000	6 x 8 cm tender red area l/tricep.  Pt describes elevated temp to 103 at home responded to ibuprofen.  Ice to injection site. Vague Shortness of Breath sx's but transient resolved.				Y					Y	01/19/2000	01/19/2000	0		PUB	OTH	Baclofen	NONE		~ ()~~~In patient		1						1	Dyspnoea; Injection site hypersensitivity; Injection site pain; Pyrexia; Dyspnoea; Injection site hypersensitivity; Injection site pain; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~02979~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~0045J~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~PARKDALE PHARMACEUTICALS~02979P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~MERCK & CO. INC.~0045J~1~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0133808	02/08/2000	NY	16.0	16		M	02/05/2000	1/28/00, 2:30am, Febrile 101.2, 4:00am, febrile to 103.2 & chills. 1/29/00, red welt (size of grapefruit), raised at site of 2 injections. Rx'd w/Tylenol, Benadryl po & cream to site. Redness fading by 1/31 & temp down & edema, quarter size									Y	01/26/2000	01/28/2000	2	Chest Xray, Urine Screen both neg, WBC, Neutrophil , Mono	UNK	UNK	Pepcid, Pericolace, Celebrex, Zinc, Vit-A,D,C, Senokot MVI, Heparin S.Q.	Paraplegia Sp, T8, T9 Laminectomy	? Latex, ? Ciprofoxacin, ? Kefzol			1						1	Injection site hypersensitivity; Injection site mass; Pyrexia	FLU3~PFIZER\WYETH~4998261~1~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1482J~1~IM~RL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0133817	02/08/2000	CA	56.0	56		F	01/11/2000	1/8/00, itchy palms bilaterally; > over body during day. Taking Benadryl for severe itching; Gold Bond. Red, raised, pin-head areas over body & discomfort. Temp 102.									N	01/07/2000	01/08/2000	1	NONE	PUB	PVT	Cardizem, Dyazide	NONE	HTN		CA000004	1						1	Pain; Pruritus; Pyrexia; Rash maculo-papular	FLU3~PFIZER\WYETH~4998221~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0133822	02/08/2000	MA	2.0	2	.4	M	02/04/2000	W/in 15 min post vax, papular rash on arm, subsequently spreading over body. No resp sx. No vomiting. Had not been ill. Devel diarrhea next day. No egg allergy.				Y					Y	10/25/1999	10/25/1999	0		PVT	OTH	Amoxicillin finished 10 days prior to event.	NONE	Growth hormone difficiency. On Humatrope.	~ ()~~~In patient		1						1	Diarrhoea; Rash maculo-papular; Rash papular	FLU3~CONNAUGHT LABORATORIES~U0107AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0107AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0133824	02/08/2000	WV	56.0	56		F	01/13/2000										Y	10/20/1999			UNK	PUB	PVT	UNK	UNK		~ ()~~~In patient		1						1	Unevaluable event	FLU3~PARKDALE PHARMACEUTICALS~0267AP~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0133836	02/09/2000	NY	53.0	52		F	01/28/2000	Pt was dx w/ Guillian-Barre. Cause of death given as cardiac arrest.	Y	05/22/2000	Y	Y	Y				N	11/29/1999	12/24/1999	25	+ CP and  FMG	PVT	PVT	Norvase, Dilantin	NONE	Seizure disorder, HTP			1						1	Cardiac arrest; Guillain-Barre syndrome	FLU3~SANOFI PASTEUR~U0104AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0043J~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Results in Death	Influenza
0133851	02/10/2000	NY	49.0	49		M	01/26/2000	On 11/21/96, pt recv'd Fluogen vax. In Dec '96, he dvlped cough, nasal congestion, & nausea. Dxed on 12/17/96 w/ Guillain-Barre syndrome.Pt was hospitalized & tx w/ plasmapheresis.He was discharged w/ weakness & balance problems.					Y				U	11/21/1996	12/01/1996	10	UNK	UNK	UNK	Advil, Norvasc		hypertension, fracture of ankle after discharge from hospital for vax reaction.	~ ()~~~In patient	0010150M0000001	1						1	Asthenia; Coordination abnormal; Cough; Guillain-Barre syndrome; Nausea; Rhinitis	FLU3~PARKE-DAVIS~00376P~2~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0133866	02/10/2000	CA	43.0	43		F	01/25/2000	5 days post vax, itching and rash after 4. Red at site. 1-2 mm raised papules with red cneter on upper back, chest, L thigh, abd.									Y	01/13/2000	01/17/2000	4	NONE	PUB	PVT	Paxil, Ditropan XL, Viox	NONE	Allergies: PCN/Sulfa, fibromyalgia	~ ()~~~In patient		1						1	Injection site hypersensitivity; Pruritus; Rash maculo-papular; Pruritus; Rash papular	FLU3~CONNAUGHT LABORATORIES~U0166AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0166AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0133876	02/10/2000	CT	56.0	56		M	02/08/2000	Patient complained of burning rash, lump, prickly sensation at site of injection - has had this for approximately 2 months.				Y					Y	11/02/1999				PUB	PUB		NONE	Hx of allergy injections - asthmatic	~ ()~~~In patient	CT200002	1						1	Injection site hypersensitivity; Injection site mass; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~24949GA~UNK~IM A~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0133883	02/11/2000	VA	44.0	44		M	02/03/2000	No rash reported, felt sick after injection for several months, many MD visits, many lab tests and many meds including antibiotics, and antihistamines.									Y	10/19/1999				PUB	UNK		NONE		~ ()~~~In patient		1						1	Malaise	FLU3~PARKDALE PHARMACEUTICALS~02089P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0133884	02/11/2000	MD	69.0	69		F	02/07/2000	Pt c/o inability to lift l/arm, redness @ site.  Swollen whol top of arm, c/o pain at inject site to l/arm.									Y	01/24/2000	01/27/2000	3	NONE	PVT	PVT		HTN, Type II diabetes		~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4998255~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0133891	02/11/2000	NY	60.0	59		F	11/20/1999	Pain in finger tips post vax. Devel pain w/ range of motion from shoulder to below elbow. No open areas, redness, warmth.										10/29/1999	10/29/1999	0		UNK	UNK	NONE	NONE	NONE		NY99045	1						1	Hypokinesia; Pain	FLU3~PARKDALE PHARMACEUTICALS~01989P~3~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0133894	02/11/2000	NY	49.0	49		F	11/16/1999	Pt experienced diarrhea, neck stiffness, ringing in ears, nausea, chills, body aches, injection site pain, malaise, abd pain.				Y					U	11/12/1999	11/13/1999	1		UNK	PUB	Zestril, climara	Scratchy throat	NKDA decreased platelet count		NY99003	1						1	Abdominal pain; Chills; Diarrhoea; Injection site pain; Malaise; Myalgia; Nausea; Nuchal rigidity; Tinnitus	FLU3~PARKDALE PHARMACEUTICALS~00199P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0133900	02/14/2000	WI	57.0	57		M	02/07/2000	On 10/25/99, pt recv'd Flu Shield & TD vax. That same day pt dvlped redness & swelling at injection site. He dvlped fever, chills, & sweats & was hospitalized on 10/28/99.Dx of cellulitis was made.					Y	2			U	10/25/1999	10/25/1999	0	WBC-700, neutrophil count-72%	PVT	PVT	hydrochlorothiazide,mavik	NONE	UNK		0884702FEB	1						1	Cellulitis; Hyperhidrosis; Injection site hypersensitivity; Injection site oedema; Leukopenia; Pyrexia; Cellulitis; Hyperhidrosis; Injection site hypersensitivity; Injection site oedema; Pyrexia	FLU3~PFIZER\WYETH~4998229~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~UNKNOWN MANUFACTURER~U0003BA~UNK~IM~~TD ADSORBED (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4998229~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|TTOX~CONNAUGHT LABORATORIES~U0003BA~UNK~IM~~TETANUS TOXOID, ADSORBED (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0133906	02/14/2000	IL	76.0	76		F	01/26/2000	Recv'd flu shot on 10/13/99.Afterwards, pt exp difficulty walking. 11'27/99, pt's husband had to support her going up & down stairs. Pt was examined on 11/29 & admitted to hosp.Pt's alertness, walking,gait,speech, & short time memory were affected. Discharge summary received states principal dx as ventriculo-peritoneal shunt malfunction with a secondary dx of pelvic mass (coincidentally discovered). Performed distal revision of vp shunt.				Y	Y	37			U	10/23/1999	11/01/1999	9	CT scan-acoustic neuroma tumor,bood tests,MRI,LP-protein level of 300,angiogram,EKG,brain biopsy	OTH	PUB	Metoprolol	NONE				1						1	Amnesia; CSF test abnormal; Central nervous system neoplasm; Gait disturbance; Hypokinesia; Somnolence; Speech disorder	FLU3~CONNAUGHT LABORATORIES~U0163AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0133914	02/14/2000	FL	36.0	36		M	02/04/2000	Pain, diarrhea, vomiting, dehydration, panic anxiety attacks, muscle pain, & weakness. Infections in right testicle, ears, gums, & pericarditis. 1987 to current: XANAX, VIOXX, ANTIBIOTICS given.				Y	Y	40		Y	N	03/01/1987	03/12/1987	11	pyschiatric tests, colonoscopy	MIL	MIL		debillitating exhaustion & dehydration & nervousness & muscle pain & weakness.	agoraphobia, irritable bowel syndrome, myofascial disorder			1						1	Agitation; Anxiety; Asthenia; Colonoscopy; Dehydration; Diarrhoea; Infection; Myalgia; Pain; Pericarditis; Psychiatric evaluation; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~CONNAUGHT LABORATORIES~~UNK~SC~UN~MENINGOCOCCAL (MENOMUNE)~1|MMR~MERCK & CO. INC.~~UNK~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|OPV~UNKNOWN MANUFACTURER~~UNK~PO~MO~POLIO VIRUS, ORAL (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~3~IM~UN~TD ADSORBED (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0133917	02/14/2000	TX	53.0	53		M	01/25/2000	Developed fever, myalgias & asthenia, 1 wk after Flu shot. This progressed to proximal muscle weakness & severe lwr extremity weakness. Extensive w/u autoimmune myalgias. Pt has limited exercise & walking; still have sx's after 3 mos.				Y					N	09/22/1999			Nml ESR, CBC, Lytes. MRI of L/Spine & EMG both mildly abnormal but abnormalties not relevant to current illness.	UNK	UNK	Lanoxin, Albuterol, Flovent	NONE	Supraventricular Tachycardia (past Hx) & Asthma			1						1	Asthenia; Hypokinesia; Myalgia; Myasthenic syndrome; Pyrexia	FLU3~PFIZER\WYETH~4998259~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0133926	02/15/2000	ID	70.0	70		F	01/07/2000	Pt c/o pain at inject site soon after vax. Next AM, R/arm from shoulder to elbow, approx 5, beet red band encircled arm. R/side of neck was itchy. Pt called ER & was recommended Benadryl. On 12/14/99, slight discoloration but improved.									Y	11/23/1999	11/24/1999	1	NONE	PUB	PUB	Synthroid, Provera, Hyzaar, Premarin, Ibuprofen	NONE	UNK	~ ()~~~In patient	ID00002	1						1	Injection site hypersensitivity; Injection site pain; Pruritus; Skin discolouration	FLU3~PARKDALE PHARMACEUTICALS~02289P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~14825~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0133936	02/15/2000	LA		30		F	01/25/2000	Passed out post vax. BP dec, no pulse, thumbs turned inward toward the palm. Comfort measure given. Left health unit w/out problem after 30 min.									Y	01/25/2000	01/25/2000	0		PUB	PUB		NONE	Always passed out after shots given.	~ ()~~~In patient	LA000203	1						1	Cardiovascular disorder; Hypotension; Syncope	FLU3~CONNAUGHT LABORATORIES~U0167AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1082J~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TD~LEDERLE LABORATORIES~465315~2~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0133946	02/15/2000	PA	56.0	55		F	02/03/2000	Had chest noises, wheezes & spit blood. Throat swelling a lot when lying down at night. Sit in recliner, legs & feet swelled still.				Y					N	11/16/1999	11/18/1999	2	UNK	PVT	PVT	Serentil, trazadone	NONE	Cold 1 week before	~ ()~~~In patient		1						1	Asthma; Haemoptysis; Laryngospasm; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0133967	02/15/2000	MD	44.0	44		F	11/23/1999	L deltoid inject site from vax reddened, raised area approx 5 cm with ecchymosis at inject site. Resolved on own.									Y	11/22/1999	11/23/1999	1		UNK	OTH	NONE	NONE	Allergy: PCN, preservatives, eye GTT,	~ ()~~~In patient		1						1	Ecchymosis; Injection site mass; Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0133982	02/15/2000	CA	32.0	32		F	01/21/2000	Syncopal episode approximately 4 hours following vaccine admin. REaction included seizure like activity.				Y					Y	11/05/1999	11/05/1999	0		MIL	MIL	Nortryptyline, Prozac, Wellbutrin			~ ()~~~In patient		1						1	Convulsion; Syncope	FLU3~PFIZER\WYETH~4998235~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0133984	02/15/2000	MN	41.0	41		F	01/25/2000	12:45-eyes itchy, grainy, vision blurred, eyes red and swollen. 1:15-Mouth tingly with metallic taste. 1:45-burning and itching inside ears. 2:30-red itchy blotches on face.Throuout evening pt was diaphoretic. Tx with Benadryl, Prednisone.				Y					Y	01/24/2000	01/24/2000	0	NONE	PUB	UNK	Propulcid, Zantac, Naproxin	NONE		~ ()~~~In patient		1						1	Amblyopia; Conjunctivitis; Dysgeusia; Ear disorder; Eye disorder; Face oedema; Paraesthesia oral; Pruritus; Rash maculo-papular	FLU3~PARKDALE PHARMACEUTICALS~02189P~4~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0133989	02/15/2000	WA	86.0	86		M	01/21/2000	10 days post vaccination, pt experienced malaise, headache, chills alternating with profuse sweating - all symptoms lasting for six weeks.									Y	10/29/1999	11/18/1999	20	Chest X-ray, blood work, urinalysis	PUB	MIL		NONE	NONE	~ ()~~~In patient		1						1	Chills; Headache; Hyperhidrosis; Malaise	FLU3~PFIZER\WYETH~4998247~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0134031	02/15/2000	FL	42.0	42		M	01/22/2000	Baseball sized cellulitis area to L/tricep-decreased range of motion due to edema. Did not extend past elbow.									Y	11/20/1999	11/21/1999	1	NONE	MIL	MIL		NONE	(+) PPD, PCN	~ ()~~~In patient		1						1	Cellulitis; Oedema	ANTH~MICHIGAN DEPT PUB HLTH~FAV024~3~SC~LA~ANTHRAX (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~U0168AA~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0131806	02/16/2000	MD	52.0			F	11/05/1999	Pt became dizzy after she was given flu shot. Her blood pressure increased and her blood sugar was 80. She was placed in shock position and dr called.				Y					U					PUB	OTH	Synthroid, Zantac		arthritis			1						1	Arthritis; Dizziness; Hypertension; Sinusitis; Thyroid disorder	FLU3~PFIZER\WYETH~4998243~4~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0134073	02/16/2000	CA	32.0	32		F	01/27/2000	Sudden onset of fatigue,nausea,& chills approx 6 hrs after vax.  The next am she exp twitching of lt arm,numbness,& tingling progressing to entire lt side w/ eventual involvement of whole body. Describes muscle spasms,visual disturbance,&				Y	Y	3			Y	10/09/1999	10/19/1999	10	CAT scan, MRI, EEG-unremarkable	OTH	PVT	antibiotic, Prozac		bipolar disorder			1						1	Asthenia; Chills; Coordination abnormal; Hypertonia; Muscle twitching; Nausea; Paraesthesia; Visual disturbance	FLU3~PFIZER\WYETH~4998233~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0134075	02/16/2000	MO	47.0	47		F	02/07/2000	1 wk following vax, pt dvlped rash & was dxed w/ poison ivy. 2 wks following vax, pt dvlped pain in joints; tx w/ Celebrex & cortisone. On 11/18, pain was so bad & hands were swollen that pt went to ER.Tx w/ Tylenol w/ codeine.				Y				Y	N	11/02/1999	11/05/1999	3	tested for lupus, lyme, etc	PUB	PUB		NONE	NONE			1						1	Arthralgia; Oedema peripheral; Rash	FLU3~CONNAUGHT LABORATORIES~U0163AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0134087	02/16/2000					F	11/05/1999	3 hrs after rcv'ng flu vax, hives devel on hands, arms and trunk. Shortly thereafter, hives became generalized. At ER rcv'd Benadryl. Sx resolved.				Y					Y	10/28/1999	10/28/1999	0		UNK	UNK				~ ()~~~In patient		1						1	Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0134089	02/16/2000	WI	82.0	82		U	02/11/2000	3 hrs post vax, felt SOB and voice got very husky.									Y	10/22/1999	10/22/1999	0		PVT	PVT	Tapazole, Cardura, Prilosel, Amaryl, Vitamins		HTN, DM-II, Hyperthyroidism, mild COPD, DJD, GERD.	~ ()~~~In patient		1						1	Dysphonia; Dyspnoea	FLU3~CONNAUGHT LABORATORIES~40163AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0134091	02/16/2000	WA	61.0	61		F	01/06/2000	Extreme redness and swelling below site of vax. REd whelts 5x4.5 form reddened swollen and tender diffuse pattern. Probably Pneumococcal allergic reaction.										01/03/2000	01/03/2000	0	NONE	PUB	PVT	NONE	NO	Allergy: Codine	NONE~ ()~~~In patient	WA001633	1						1	Ecchymosis; Hypersensitivity; Injection site hypersensitivity; Injection site oedema; Pain; Urticaria	FLU3~PFIZER\WYETH~4998210~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~459040~1~IM~LA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~73023A~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0134093	02/16/2000	WA	23.0	23		F	01/06/2000	Pt exp pain, swelling at inject site night of vax. No hives, resp problems. Site redness and 50 cent size duration. No streaking or fever. Shoulder ached.										01/04/2000	01/04/2000	0	NONE	PUB	PUB	Albuterol inhaler PRN	NONE	Asthma, No allergies to meds.	~ ()~~~In patient	WA001635	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Pain	FLU3~PARKDALE PHARMACEUTICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0134095	02/16/2000	OH	40.0	40		M	01/19/2000	Post/vax, pt developed increasing pain in arm, shoulder, neck & head, followed by rash in left arm, shoulder & chest. Pt went to PMD for treatment.				Y					N	01/11/2000	01/12/2000	1		PUB	PUB		NONE	NONE	~ ()~~~In patient	OH00006	1						1	Headache; Neck pain; Pain; Rash	FLU3~CONNAUGHT LABORATORIES~U0160AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0134105	02/16/2000	NY	38.0	37		F	02/10/2000	Edema knees & ankles, which progressed to generalized edema, hands, feet & face. Extreme pain in all joints. Painful to walk or move hands.									Y	11/17/1999	11/20/1999	3	NONE	PVT	PVT	NONE	NONE	Allergic to Bioxin (but not eggs).	~ ()~~~In patient		1						1	Arthralgia; Hypokinesia; Oedema peripheral	FLU3~PFIZER\WYETH~4998254~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0134111	02/16/2000	ND	48.0	47		F	02/07/2000	Pt awoke 3:00am, 1/19, with a dull headache, covering front & top of her head & stuffy feeling. By the end of day, she hurt all over. States she had a fever but did not take temp. Says she was in bed for 2 days.									Y	01/18/2000	01/19/2000	1	NONE	PUB	PUB	Estrogen	NONE	Sulfa allergy; gets headaches but states this was different.	Pt had similar rxn w/last Flu vax, 7 years ago.~ ()~~~In patient		1						1	Headache; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4998254~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0134117	02/16/2000	NY	49.0	49		M	01/26/2000	Pt rcvd vaccine 11/21/99, in Dec, 99, pt developed a cough, nasal congestion, nausea, without fever.  The pt saw his MD and was immediately hospitalized.  Dx of GBS. He was discharged with weakness and balance problems & fell and fx ankle.							Y		U	11/21/1996	12/01/1996	10		UNK	UNK			Hypertension	~ ()~~~In patient	M0000001	1						1	Asthenia; Coordination abnormal; Cough; Guillain-Barre syndrome; Injury; Nausea; Pyrexia; Rhinitis	FLU3~PARKDALE PHARMACEUTICALS~00376P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation	Influenza
0134119	02/16/2000	AZ	36.0	36		M	02/07/2000	Developed a hyperactive thyroid.  Lost weight (25 lbs), sleep loss, shaking, irritable, etc.  Dx, Graves Disease.								Y	N	11/16/1998	11/16/1998	0		MIL	MIL		NONE				1						1	Agitation; Hyperthyroidism; Insomnia; Tremor; Weight decreased	ANTH~MICHIGAN DEPT PUB HLTH~~UNK~~~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0134144	02/17/2000	MN	63.0	63		F	02/09/2000	Nausea and repeated vomiting for 8 hours. Weak and in bed next day.  Temp of 102 degrees still at the end of the day. Just drank some liquid. Episode lasted 36 hours.  Lost 6 pounds.									Y	01/14/2000	01/18/2000	4		OTH	OTH	Dilantin	None				1						1	Asthenia; Pyrexia; Vomiting; Weight decreased	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0134154	02/17/2000	CA	41.0	41		F	09/17/1999	At time of vax w/bioject system, I felt pain all the way down to my elbow. By early evening, my arm was so sore, that i could not move it. I woke up at 1:00am, w/numbness in entire R/arm & side of face. Pain in eye, ear & neck w/tingling.				Y					U	09/14/1999	09/15/1999	1		PUB	PUB		NONE	NONE	~ ()~~~In patient		1						1	Ear pain; Eye pain; Hypokinesia; Neck pain; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4998216~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0134156	02/17/2000	NE	39.0	39		F	02/08/2000	Patient received the vaccine on 12/1/99.  Become febrile (103.5).  Went home from work that afternoon.  Missed following day.									Y	12/01/1999	12/01/1999	0		PUB	PUB				~ ()~~~In patient		1						1	Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0163AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0134157	02/17/2000	MI		50		M	11/08/1999	Ringing in ears, 2 hours following injection.  Fever blister - lip - erupted 12 hours post injection.  Ringing in ears presists at decreased lever on this date.  Still has some ringing in ears.										11/02/1999	11/02/1999	0	NONE	PUB	PUB	NONE	NONE	NONE	~ ()~~~In patient		1						1	Mouth ulceration; Tinnitus	FLU3~CONNAUGHT LABORATORIES~40152AB~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0134158	02/17/2000	MI	59.0	59		F	10/13/1999	3 redness and slight swelling at inject site.  Noticed approximately 19 hours after flu shot.  Minimal itching.									Y	10/12/1999	10/13/1999	1	NONE	PVT	PVT	Chlortrimeton		Asthma, allergy to environmental allergens	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~7+~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0134160	02/17/2000	MI	21.0	21		F	10/21/1999	Awakened with nausea - vomited.									Y	10/14/1999	10/15/1999	1		PUB	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Vomiting	FLU3~CONNAUGHT LABORATORIES~U01516AA~2~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0134161	02/17/2000	MI	47.0	47		M	10/13/1999	Received inject 10/5/99. 10/6/99 developed nausea after eating. 10/8/99 temperature of 99.5 and weakness. 10/9/99 went to MD, no treatment.									U	10/05/1999	10/06/1999	1	WBC - 11000	UNK	UNK	Claritin, Rispertol	NONE				1						1	Nausea; Pyrexia	FLU3~SANOFI PASTEUR~V0129AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0134168	02/17/2000	LA	42.0	48		M	02/16/2000	Flu shot 1/20/00. Onset of itching to trunk and fingers and whelps under his r/arm on 1/24/00.				Y					U	01/20/2000	01/24/2000	4		PVT	PVT		NONE		~ ()~~~In patient		1						1	Pruritus; Urticaria	FLU3~PFIZER\WYETH~4998422~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0134170	02/17/2000	NY	42.0	42		F	02/16/2000	Tingling, pins and needles, burning sensation of muscles, R/O Guillain Barre, also considered CIPD, chronic vaginitis.  Treated with Neurontin, prescribed by neurologist.				Y					N	10/22/1999	10/25/1999	3	Elevated calcium and protein, MRI	UNK	UNK	Dermulen	NONE	NONE			1						1	Guillain-Barre syndrome; Hypercalcaemia; Laboratory test abnormal; Myalgia; Paraesthesia; Vaginal infection	FLU3~PFIZER\WYETH~4998261~3~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0134183	02/18/2000	OK	46.0	46		F		Recv'd flu shot on 11/3.Later that evening, pt dvlped stomach pains,diarrhea,dizziness,sweating,weakness,& headache. Woke up the next morning w/ cont'd headache & distorted vision. Saw retina specialist who dxed ischemic optic neuritis.				Y					N	11/03/1999	11/03/1999	0		PVT	PVT		NONE		~ ()~~~In patient		1						1	Abdominal pain; Asthenia; Diarrhoea; Dizziness; Headache; Hyperhidrosis; Optic neuritis; Visual disturbance	FLU3~PARKDALE PHARMACEUTICALS~02189P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0133410	02/20/2000	MN	45.0	44		F	01/05/2000	Flu shot Oct. During hair cut in Dec, noted quarter sized bald spot on back of head.				Y						10/15/1999			Blood work, biopsy.	UNK	UNK			Eczema on hands.	~ ()~~~In patient		1						1	Alopecia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0134204	02/29/2000	NJ	8.0	8		M	02/17/2000	Angioedema, uticaria, difficulty breathing, fever, headache, myalgia, and stomachache devel 10/31/99, post vax. 2nd dose of Flu Shield rcv'd w/out AE.				Y					U	10/18/1999	10/31/1999	13	UNK	OTH	OTH	UNK	UNK	Asthma NOS		1102217FEB	1						1	Abdominal pain; Angioneurotic oedema; Dyspnoea; Headache; Myalgia; Pyrexia; Urticaria; Abdominal pain; Angioneurotic oedema; Dyspnoea; Headache; Myalgia; Pyrexia; Urticaria	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~CONNAUGHT LABORATORIES~~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0134206	02/29/2000	MN	52.0	52		F	02/03/2000	Irregular heart beat approx 1 mo after vaccine; seen by Dr. Continues to take Tenormin 25 mg/day. Symptoms continue but decreased frequency.				Y					N	10/28/1999	11/28/1999	31	EKG-Holter moniter; Thyroid function	PVT	PVT	Premarin, Provera	NONE	Rheumatic fever; borderline high blood pressure	~ ()~~~In patient		1						1	Arrhythmia	FLU3~PFIZER\WYETH~4998263~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0134238	02/29/2000	PA	37.0	37		F	01/18/2000	Approx 1 wk post/vax, arm became achey, sometimes in shoulder joint & sometimes in muscle. After about 2 mos, seen by Dr & had x-rays which were neg. Noticed mostly when raised arm above head or lifting something heavy.				Y					U	10/27/1999			X-rays for bursitis & arthritis 12/29/99-negative	PUB	OTH	NONE	NONE	NONE	~ ()~~~In patient	2008	1						1	Arthralgia; Hypokinesia; Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~U0158AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0134239	02/29/2000	PA	43.0	43		F	01/10/2000	Huge red welt (puffy) by next working day. 24 hrs after injection, red, raised, warm to touch, 3 around large welt. Referred to PMD. 3 days later, resolved. No treatment applied.				Y					Y	10/26/1999	10/27/1999	1	NONE	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient	2009	1						1	Rash maculo-papular; Urticaria; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0169AB~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0134258	02/29/2000	OH	49.0	48		F	02/16/2000	Transverse myelitis per neurologist.				Y					N	10/21/1999	11/04/1999	14	MRI	UNK	UNK						1						1	Myelitis	FLU3~CONNAUGHT LABORATORIES~U0158AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0134298	02/29/2000	PA	4.0	4		F	02/17/2000	Within 48 hrs of 2nd Fluzone, the pt had the first & only febrile seizure (T=103) of her life. It lasted less than 5 min. Pt was taken to ER. Had normal exam & labs. Saw Dr on 2/17, no neurologic deficits, fever & totally nml exam.				Y					Y	02/14/2000	02/16/2000	2	Na+=144, WBC=4,000, Glucose=108	PVT	PVT	NONE	NONE	NONE	~ ()~~~In patient		1						1	Febrile convulsion	FLU3~CONNAUGHT LABORATORIES~U0186AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0134312	02/29/2000	CA	76.0	74		F	02/02/2000	1 mo post vax pt has blister like leisons on L arm at inject site. Area of red and blister like skin 15 mm on L deltoid. Comes and goes, itches, no pain.									U	10/02/1999	11/15/1999	44		PUB	PUB	thyroid, estrogen, progesterone	NONE	On thyroid med for years, DM		CA990170	1						1	Injection site hypersensitivity; Injection site reaction; Pruritus	FLU3~MEDEVA PHARMA, LTD.~E30889KA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0134313	02/29/2000	CA	68.0	68		F	11/05/1999	Onset 5 hrs post flushot: nausea, felt hot & weak. Went to dr. Temp 100. No lab work. Recovered 2 wks.				Y					Y	10/18/1999	10/18/1999	0	NONE	PVT	PUB		NONE	NONE	~ ()~~~In patient	990171	1						1	Asthenia; Nausea; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E26919HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0134340	02/29/2000	FL	51.0	51		F	02/16/2000	Post vax, leg became numb. 2 days later, felt numbness around chest down to lower extremeties. Numbness of chest and fingers still 80%. Legs and feet gone.				Y					Y	01/05/2000	01/14/2000	9	MRI of spine and brain. Spinal tap performed.	PUB	PUB	Estrogen patch, Progesterone Atenelol	NONE	Mitral valve prolapse, early osteoporosis.	~ ()~~~In patient	FL00004	1						1	Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E30899LA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0134366	02/29/2000	FL	69.0	69		F	02/15/2000	Redness at inject site, inflammation, tenderness, general body aches, golf ball size lump in auxillary area, devel 12 hrs post vax. Difficulty in moving affected arm. Nausea, vomitting, diarrhea. Resolved w/in 48 hrs of vax.									Y	10/27/1999	10/27/1999	0	NA	PUB	PVT	UNK	NONE	NKA			1						1	Hypokinesia; Injection site hypersensitivity; Injection site inflammation; Injection site mass; Injection site pain; Myalgia; Vomiting	FLU3~CONNAUGHT LABORATORIES~131AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1693H~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0134406	02/29/2000	IL	56.0	56		F	02/25/2000	Post vax, pt immediately devel inject site react characterized by swelling, pain & heat. Lost 12 pounds and was 'developing GBS'. She devel cancer, is receiving chemotherapy. Hosp for unspecified tests. Per 60-Day FU: double vision 10/99; Guillain Barre Syndrome 1/2000, still have this. Have not worked since 1/2000.					Y				N	10/06/1999			UNK	PUB	PVT	Cardizem	NONE	UNK		1183123FEB	1						1	Diplopia; Guillain-Barre syndrome; Injection site oedema; Injection site pain; Neoplasm malignant; Vasodilatation; Weight decreased	FLU3~PFIZER\WYETH~4998263~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0134439	02/29/2000	IN	53.0	53		F	01/18/2000	A nurse reported that a 53 year old female vaccinated on 11/10/1999, post vax, on 11/11/1999, she felt sick to stomacn and developed an injection site reaction characterized by a 3.5 circle of redness and warmth. The pt recovered.									Y	11/10/1999	11/11/1999	1	UNK	OTH	OTH	UNK	NONE	UNK		HQ7688307DEC1999	1						1	Dyspepsia; Vasodilatation; Dyspepsia; Injection site hypersensitivity; Vasodilatation	FLU3~PFIZER\WYETH~4998260~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4998260~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0134450	03/01/2000	TX	20.0			F	02/28/2000	Approx 2 mos post vax, devel skin rash, swollen joints, flu-like feeling. Upon traveling to France, she was admitted to hosp and released same day.					Y	1			Y	10/08/1999	12/01/1999	54	UNK	OTH	OTH	UNK	UNK	UNK		1255625FEB	1						1	Influenza; Osteoarthritis; Rash	FLU3~PFIZER\WYETH~4998211~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0134486	03/02/2000	IL				F	02/29/2000	Pt states that she received vaccine and subsequently developed Guillain Barre Syndrome. A female reported that she received an injection of Flu Shield (1999-00 Formula) and subsequently developed Guillain Barre Syndrome.  As of 22-FEB-2000, no further information was available.  This report of a serious, labeled event is being submitted in a 15-day time frame, as requested by FDA.									U				UNK	OTH	OTH	UNK	UNK	UNK		1216624FEB	1						1	Guillain-Barre syndrome	FLU3~PFIZER\WYETH~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0134504	03/03/2000	MS	38.0	38		F	02/18/2000	Pt received vaccination and on same day noticed swelling, raised soft non-tender areas, bilaterally above clavicles.  Denies other sx's, mild sore throat on following morning.  Given Benadryl and motrin, pt discharged.				Y						10/14/1999	10/15/1999	1	BP - 105/49, T - 99.1,  P - 61, R - 16	UNK	UNK	Tenormin, Birth Control		NKA, irregular heart beat	~ ()~~~In patient		1						1	Hypotension; Hypoventilation; Oedema; Pharyngitis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0134575	03/07/2000	KS	50.0	50		F	03/02/2000	Sister of pt stopped by clinic to pay for vax. Stated that flu shot caused sister's death. Began to feel ill next day. Transported to ER on 11/12 by ambulance, died few hrs later. Stated pt didn't see MD between 10/20 & 11/12/99.	Y	11/12/1999		Y					N	10/20/1999	10/21/1999	1		PUB	PUB		Being considered for liver transplant.	Hx: Hep B, Hep C, Cirrhosis of liver.	~ ()~~~In patient		1						1	Malaise	FLU3~CONNAUGHT LABORATORIES~U0155AA~UNK~IM A~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0134601	03/07/2000	OH	63.0	63		F	03/02/2000	For 2 weeks post vax, had severe aches and pains. Had no local reaction. Twelve to fifteen times since then, pt has had a 'hurting' in her arm lasting 5-10 minutes in the same area shot was administered. After each 'hurting' episode, she stated that she generally does not feel well for the next couple of days. Pt has not been to the doctor.									N	10/14/1999	10/14/1999	0	NONE	PUB	PUB				Severe muscle aches and pains for 2 weeks post vax in 1998.~Influenza (Seasonal) (no brand name)~~62.00~In Patient		1						1	Injection site pain; Malaise; Myalgia; Pain	FLU3~CONNAUGHT LABORATORIES~U0144AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0134605	03/07/2000	KY	49.0	49		F	03/01/2000	Local muscle atrophy.				Y					U	11/29/1999	12/25/1999	26	EMG - NCV results pending.	PVT	OTH	NONE	Brochitis - resolving	NONE			1						1	Muscle atrophy	FLU3~CONNAUGHT LABORATORIES~U0136AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0134630	03/08/2000	SC	69.0	69		F	03/07/2000	Awoke with rubbery legs, urinary incontinence, fell 19 days post vax. At ER, cath inserted, release. Next day, admitted to hosp. Treated improved. Neuropathy persists, pt continues to use hand walker, incontinence of urine persists. Diag with GBS.				Y	Y	4			N	12/08/1999	12/27/1999	19	CT of brain, electrical stimulation, spine xray, MRI	PVT	OTH	Motrin, Mevacor, Synthroid, Evista Demadex, K, Propursid	NONE	Mixed connective tissue disease, osteoporosis, arthritis.			1						1	Guillain-Barre syndrome; Myasthenic syndrome; Neuropathy; Urinary incontinence; Guillain-Barre syndrome; Nerve injury; Paralysis	FLUX~UNKNOWN MANUFACTURER~G0008~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~G0008~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0134667	03/08/2000		53.0	53		F		Swelling of feet and hands with itching skin. Desquamation of plantar area.										11/26/1999	11/26/1999	0		UNK	UNK			Allergic to Penicillin			1						1	Dermatitis exfoliative; Oedema peripheral; Pruritus; Dermatitis exfoliative; Oedema peripheral; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0159AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0159AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0134683	03/10/2000	TN	35.0	35		M	02/10/2000	Arm swelling from elbow to shoulder in L/arm where shot given. Arm very hot & firm in effected area. Dizziness when lying down. Upset stomach after eating. Rx: KEFLEX. Effects subsided on 1/15/00.				Y					Y	01/08/2000	01/08/2000	0		MIL	MIL	NONE		NONE			1						1	Dizziness; Dyspepsia; Injection site mass; Injection site oedema; Vasodilatation	ANTH~UNKNOWN MANUFACTURER~~3~SC~UN~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0134690	03/10/2000	AK	23.0	23		F	03/03/2000	Headaches, sleep deprivation, stomach pain (daily), arm swollen, red & sore, muscle aches and nausea. Pt partially recoverd - headaches, muscle and joint aches not as often as in the past. Pt missed 4 work days due to this event. At time of evaluations I wasn't sure it was ANTHRAX. Pt did not received any furtheer ANTHRAX shots since the reported event Per follow-up: 7/25/00 1601 - 1st attempt to reach pt - message left on answering machine requesting a call back. 7/26/00 1520 - 2nd attempt to reach pt - message left on answering machine requesting a call back. 7/27/00 1355 - Call back from pt - she continues to have severe heaaches and has been seen by doctors - Consent form sent for medical records.				Y					U	09/20/1999	10/28/1999	38		MIL	MIL	ortho-tricyclen	NONE	NONE			1						1	Abdominal pain; Headache; Injection site hypersensitivity; Injection site oedema; Injection site pain; Insomnia; Myalgia; Nausea	ANTH~MICHIGAN DEPT PUB HLTH~FAV037~3~~~ANTHRAX (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4998234~2~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0134756	03/10/2000	WI	4.0	4		F	03/06/2000	Pt brought to ER w/fever of 106, 3 hrs post/vax. Pt became delirious. By the next AM, pt had a seizure & was transferred to other hosp & admitted. Put on respirator & managed for encephalopathy & cerebral edema. MRI abnormal & pt w/RSV.60 day follow-up dated 11/01/00 states the pt is fully recovered, but MRI of brain shows some resigual abnormality.			Y	Y	Y	42		Y	Y	01/05/2000	01/05/2000	0	MRI brain-diffuse abn white matter, LP (2) both nml, Viral culture, Toxicology test on blood-neg, electrolytes-nml, elevated Creatine Kinase-7,000, serum organic acid & amino acid analysis-nml.	PVT	PVT	Albuterol	RSV infection	Asthma			1						1	Blood creatine phosphokinase increased; Brain oedema; Coma; Confusional state; Convulsion; Delirium; Dyspnoea; Encephalopathy; Hemiplegia; Infection; Pyrexia; Speech disorder	FLU3~PFIZER\WYETH~4998229~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1483J~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0150026	03/13/2000	OH	38.0	38		M	03/03/2000	Fever, nodule and aching joints.									N	02/07/2000	02/07/2000	0		MIL	MIL	NONE	NONE	NONE			1						1	Arthralgia; Pyrexia; Skin nodule	ANTH~MICHIGAN DEPT PUB HLTH~~6~SC~LA~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0150050	03/14/2000	GA	30.0	30		F	01/07/2000	Pt states that post vax, arm became sore without swelling or redness. Denies any swelling or redness up to this date but right arm muscle area where vaccine was given, remains sore, especially at night when she lays on it. Instructed to notify MD of status.									U	11/29/1999	11/29/1999	0		PUB	PUB	Synthroid, Pre-natal vitamins	NONE	NONE		GA00009	1						1	Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~01989P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0150068	03/14/2000	MS	65.0	65		F	02/25/2000	Pt woke up with stiff neck, same night post vax, radiated down shoulder and stayed 4 days, then moved to back of legs. Hurt from back of leg down, could hardly walk, lasted 3 days, went to back of heels. Saw DR 11/22/99 for symptoms and was treated for inflammation with Z-Pack. Saw him on 12/3/99, after heels and feet started swelling. Pt was sent to orthopedic Dr and then went to an Internist, who found enlarged lymph nodes between heart and lungs. Pt had a heavy feeling in her chest, was treated with Zithromax, Cataflam and pt had a list of medicines she was treated with. Pt states she had spots in front of her eyes. On 12/22/99, her skin and eyes were red. Also, had red knots in legs. She saw a Dr on 12/17/99. She also, ran temperature at night during this period. Pt is still having problems with these symptoms. States, also, she had swelling in ankles, skin dry and peeling. Still under Dr's care. Dx with sarcoidosis. Pt is seeing a Dr in Oncology and has an appointment to see Rheumatologist on 3/6/00.				Y					N	11/12/1999	11/12/1999	0		PUB	PUB		NONE	allergy to PCN, hypertension		MS00006	1						1	Chest pain; Dry skin; Erythema; Hypertonia; Hypokinesia; Inflammation; Lymphoedema; Musculoskeletal stiffness; Ocular hyperaemia; Pain; Pyrexia; Sarcoidosis; Skin exfoliation; Visual disturbance	FLU3~PFIZER\WYETH~4998232~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0150082	03/15/2000	WI	69.0	69		M	02/25/2000	On 12/2/99, seen in urgent care with complaint of numb hands and feet from 12/1/99. Presented with numb hand and feet complaint along with a headache. Tongue and lip slightly numb, also, weak legs and noticed facial droop on left side. Admitted to the hospital. Dx in hospital with Guillain Barre Syndrome and treated with gammaglobulin. Symptoms worsened to point that pt could not even close his eyes. Spent 4 weeks in rehab after 2 weeks in hospital just to keep muscles going. He had a relapse 5 weeks ago when he became weaker. Follow up 06/05/2000: Patients final diagnosis Gullian-Barre Syndrome.  Diagnosis was made by neurologist. Patient did not experience any other illness within the 4 weeks before the onset of GBS syndrome.  Patient received previously the influenza vaccine.				Y			Y		U	11/12/1999	12/01/1999	19	CT head-negative, ECG-negative, Chem 13-negative except glucose 236, CO2-32, CL-91.	PVT	PVT	Proscan, Verapamil, Zaroxolyn	NONE	hypertension, no known allergies			1						1	Blood chloride decreased; Blood glucose increased; Carbon dioxide increased; Facial palsy; Guillain-Barre syndrome; Headache; Hypoaesthesia; Hypoaesthesia oral; Muscular weakness	FLU3~PFIZER\WYETH~4998247~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0133744	03/17/2000	DE	43.0	43		M	02/16/2000	12/8/99, pt received Flu vaccine and Anthrax vaccine.  Pt was hospitalized on 1/1/00 to rule out GBS. Dx is confirmed positive for GBS.  Patient is still hospitalized and undergoing treatment.Pt. developed ascending parethesthesia starting 25Dec99. Pt. was admitted Jan1st/00 to Medical Center. Pt. was diagnosed with Guillan Barre. Pt. transferred to Rehab on 15Jan00 but had recurrence of Guillan Barre and needed to be transferred to MC 2Feb00. Pt. needed intubation and began plasmaphoresis on 2Feb00. AS of 17Feb00 pt. still hospitalized.					Y			Y	N	12/08/1999	12/25/1999	17	LP CSF albumin-cytologic pattern c/w Guillain Barre and nerve condution study showing motor and sensory peripheral neuropathy c/w demyelinating features.	MIL	MIL		NONE	local rxn with nodule to past anthrax vaccination			1						2	Guillain-Barre syndrome; Guillain-Barre syndrome	ANTH~EMERGENT BIOSOLUTIONS~FAV024~5~SC~~ANTHRAX (BIOTHRAX)~1|FLU3~CONNAUGHT LABORATORIES~U0168AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|ANTH~MICHIGAN DEPT PUB HLTH~FAV024~5~SC~~ANTHRAX (NO BRAND NAME)~2|FLU3~CONNAUGHT LABORATORIES~U0168AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation,Disabling	Influenza
0150155	03/17/2000	MN	74.0	73		M	03/08/2000	Severe headaches, hallucinations, occasional confusion, short term memory loss, delusions, and paranoia of unclear duration. The pt also experienced loss of control of left foot. The pt experienced bleeding from the rectum (bright red). Annual FU: pt died. no other info provided.	Y		Y	Y	Y		Y	Y	N	11/15/1999	11/20/1999	5		PVT	PVT	B12 shot	NONE	hx of rectal incontinence, abdominal injuries, bilateral hearing loss, dementia, hypertension, degenerative joint disease, anemia			1						1	Hallucination; Headache	FLU3~CONNAUGHT LABORATORIES~U0163AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0150174	03/17/2000	PA	18.0	18		F		Flu-like symptoms: high fever, chills, aches, right arm numb, severe headache. Treatment - 10 days Ceclor 250 mg.				Y					Y	01/08/2000	01/08/2000	0		MIL	MIL	NONE					1						1	Chills; Headache; Hypoaesthesia; Influenza like illness; Pain; Pyrexia	ANTH~MICHIGAN DEPT PUB HLTH~FAV044~1~SC~~ANTHRAX (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4998235~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|YF~CONNAUGHT LABORATORIES~7393AA~1~IM~~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0150198	03/17/2000	NY	59.0	59		M	02/14/2000	Pt notices head falls to his left, shoulder droops to left, gait uncertain beginning 8 days post vax and continuing to present.									N	11/25/1999	12/03/1999	8		PUB	PUB	Vasotec	Hypertension				1						1	Gait disturbance; Muscular weakness; Difficulty in walking; Muscular weakness; Paralysis	FLU3~CONNAUGHT LABORATORIES~~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0150206	03/17/2000	MN	31.0	31		F	03/01/2000	Pt received vax on 01/06/2000. Subsequently she discovered she was 03/01/2000. She is approximately 4 weeks. PHN advised that she speak with OBGYN/prenatal care physician and that the risk of birth defects is theoretical.									U	01/06/2000				PUB	PVT	NONE					1						1	Unevaluable event	FLU3~PFIZER\WYETH~4998285~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|MMR~MERCK & CO. INC.~0555J~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0150207	03/17/2000	NC	26.0	26		M	03/01/2000	Erythema and induration to left arm just below the shoulder to elbow.				Y					Y	02/28/2000	02/28/2000	0	NONE	MIL	MIL	IPPD Connaught #C0143ab, 3rd test. Cyclobenzaprine.	NONE	Recovering from removal of spleen.			1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~U0168AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~1216J~1~SC~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0150216	03/17/2000	LA	37.0	37		F	02/29/2000	Deep, aching pain in upper right arm (area where vaccine was administered), some days worse than others. Still present after 3 months.									U	11/23/1999	11/24/1999	1	NONE	PUB	PVT	NONE		NONE			1						1	Injection site pain	FLU3~CONNAUGHT LABORATORIES~U0156AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0871H~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~LEDERLE LABORATORIES~465315~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0150248	03/21/2000		69.0			M	03/20/2000	A pharmacist reported that a 69-year-old male received an injection of Flu Shield and subsequently developed Guillain Barre Syndrome. No further information was available at the date of this report. This report of a labeled event is being submitted in a 15-day time frame requested by the FDA.									U	11/18/1999			UNK	OTH	OTH	UNK	UNK	UNK		HQ1664217MAR2000	1						1	Guillain-Barre syndrome	FLU3~PFIZER\WYETH~4992847~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0150252	03/21/2000	NJ	58.0			F	03/08/2000	Brawny edema of face, quite intense. Ruled out superior vena cava syndrome, blood clot and malignancy. Dermatology consult identified no specific etiology. Treated symptomatically with fluid removal. Recently vaccinated with influenza. 60 day follow-up dated 09/27/00 provided no additional data.					Y				U		10/14/1999			UNK	UNK			PCN allergy			1						1	Face oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0134162	03/23/2000	MI	63.0	63		M	02/16/2000	Severe chest pain, SOB, cold sweat, dizziness, faintness, hyperventilation for 45 mins, then subsided. 2nd event was the same. 3rd event was same except more severe & went to ER & was admitted with a dx of pancreatitis. Temp 102.			Y	Y	Y	2			U	11/04/1999	11/04/1999	0	Blood Test: Amylase & Lipase extremely elevated, EKG-nml, Chest XRay-nml, Ultrasound-nml, MRI-nml.	OTH	PVT	Inderol, Lobol	NONE	NONE			1						1	Chest pain; Dizziness; Dyspnoea; Hyperhidrosis; Hyperventilation; Pancreatitis; Pyrexia; Chest pain; Dizziness; Dyspnoea; Hyperhidrosis; Hyperventilation; Pancreatitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0095AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0095AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0134162	03/23/2000	MI	63.0	63		M	02/16/2000	Severe chest pain, SOB, cold sweat, dizziness, faintness, hyperventilation for 45 mins, then subsided. 2nd event was the same. 3rd event was same except more severe & went to ER & was admitted with a dx of pancreatitis. Temp 102.			Y	Y	Y	2			U	11/04/1999	11/04/1999	0	Blood Test: Amylase & Lipase extremely elevated, EKG-nml, Chest XRay-nml, Ultrasound-nml, MRI-nml.	OTH	PVT	Inderol, Lobol	NONE	NONE			1						2	Chest pain; Dizziness; Dyspnoea; Hyperhidrosis; Hyperventilation; Pancreatitis; Pyrexia; Chest pain; Dizziness; Dyspnoea; Hyperhidrosis; Hyperventilation; Pancreatitis; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0095AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0095AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0150296	03/23/2000	NE	25.0	25		M	03/16/2000	Pt developed swelling of the upper arm and upper thorax in the area of the injection site. This was associated with myalgias and arthralgias. He was treated conservatively and the swelling subsided over the next 2-3 days.				Y					Y	02/28/2000	03/01/2000	2		MIL	MIL	Inderal	NONE	NONE			1						1	Arthralgia; Injection site oedema; Myalgia	ANTH~MICHIGAN DEPT PUB HLTH~FAV037~5~SC~~ANTHRAX (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~VO168AA~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0150304	03/23/2000	NH	44.0	43		F	02/01/2000	Pt experienced burning at injection site. One hour later, experienced redness extending around arm, warm to touch, very sore. Took band aid off in the evening and skin came off with it. Seen by MD that evening, diagnosis cellulitis. Pt was given Augmentin, and went to MD again in a couple of days and then was diagnosed with a triple ulcer. Pt saw MD daily for 1 week for dressing changes. Didn't heal, pt sent to wound clinic at hospital for dressing changes. Thick scabbing as of today it has healed but remains painful and is scarred. Allergy tested for ingredients in flu vaccine - all negative. Pt has had the flu vaccine in the past with no problems.				Y					N	10/01/1999	10/01/1999	0	Biopsy-thick scarring, no bacteria	PVT	PVT	Orthocept, Celebrex	NONE	NONE		NH0003	1						1	Cellulitis; Feeling hot; Injection site erythema; Injection site pain; Skin disorder; Skin ulcer	FLU3~PFIZER\WYETH~4998220~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0150306	03/23/2000	MI	60.0	60		F	02/03/2000	Client came to HD on 2/3/2000, complaining of pain and weakness of left arm which began, post vax, flu shot, and increased during the evening and night to a throbbing aching pain. No swelling or redness noted by client at the flu shot site. Pain decreased within 3 days to a level 2 on a scale of 0-5 with arm weakness. Pain continued. Client saw PP in late December (after 12/25). Advised by PP to come to the HD, where shot was given, about the pain. Pain only noticed pt present with certain movements in a downward motion.				Y					Y	11/12/1999	11/12/1999	0		PUB	PUB		NONE	Sodium Pentothol, Compazine and Dermerol allergy. Had cardiac cath. 10/20/1999-no blockage seen.		MI2000004	1						1	Hypokinesia; Muscular weakness; Pain	FLU3~PARKDALE PHARMACEUTICALS~00199P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0150325	03/23/2000	SC	66.0	65		M	03/10/2000	Pt states that he experienced flu symptoms 6 days post vax. Pt is experiencing soreness in shoulders, down arms, hands and feet. Pain in right upper arm when gripping object with right hand.									U	12/03/1999	12/09/1999	6		MIL	MIL	ibuprofen	NONE				1						1	Arthralgia; Influenza like illness; Pain in extremity	FLU3~CONNAUGHT LABORATORIES~U0168AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466786~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0150340	03/23/2000	CA	53.0	53		F	12/13/1999	It was reported that a female pt received a Fluzone vax on 10/20/99. Reportedly on 10/21/99, the pt developed pain at the injections site that radiated to the neck and arm. The pt also had a decreased range of motion.									U	10/20/1999	10/21/1999	1	neck x-ray-disc space narrowing, posterior osteoprytic spurring.	OTH	PVT	Prozac		hx shoulder bursitis and calcifications		U1999010160	1						1	Bone disorder; Injection site pain; Joint range of motion decreased; Neck pain; Pain; Injection site pain; Joint range of motion decreased; Neck pain	FLU3~CONNAUGHT LABORATORIES~U0130AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0150376	03/24/2000	NY	36.0	36		F	02/05/2000	Pt experienced severe pain and throbbing at site of injection. Have seen orthopedists, neurologists, had MRI done, x-rays, and neurological testing of nerves. Sustained damage in radial nerve. Pt is currently taking Neurentin.				Y					N	11/08/1999	11/08/1999	0	x-rays, MRI, EMG	OTH	OTH	Triphasil	NONE	NONE			1						1	Injection site pain; Nerve injury	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0150392	03/24/2000	OR	55.0	55		F	11/02/1999	Pt experienced chills, achy bones in arms for 2-4 days, loss of appetite in the morning for 2 days. Pt stayed home and rested.									Y	10/18/1999	10/19/1999	1	NONE	PUB	PUB	Premarin, Estrace	NONE	allergy to some medications			1						1	Anorexia; Chills; Pain	DTP~CONNAUGHT LABORATORIES~7360BA~UNK~IM~LA~DTP (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4998225~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLUX~UNKNOWN MANUFACTURER~E20258KC~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0150444	03/24/2000	WI	73.0	73		F	03/15/2000	Pt experienced hives on 10/29/99 with a sore throat, body aches, flu symptoms, high fever, loss of appetite, cough, lost 10 lbs due to illness, was ill for 2 months.				Y					Y	10/26/1999	10/29/1999	3	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Anorexia; Cough; Influenza like illness; Pain; Pharyngolaryngeal pain; Pyrexia; Urticaria; Weight decreased	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0150458	03/27/2000	CA				M	03/24/2000	Blindness: A pharmacist reported that a pt received vax and subsequently developed blindness. No further information is available at the date of this report.								Y	U				UNK	OTH	OTH	UNK	UNK	UNK		HQ1286029FEB2000	1						1	Blindness	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0150495	03/28/2000	PA	42.0	41		F	02/10/2000	On 2/10/00, the pt called to ask if there was any sulfa in the Flu vaccine. The pt received the vaccine on 01/19/00 within less than 24 hours, the pt developed sore throat. The symptoms worsened on the second day, sought medical intervention, pt was placed on antibiotics. Symptoms worse in 48 hours.  Pt saw a throat specialist and was diagnosed with allergies. Client has jut completed a course of Bactim prior to flu shot. Stayed on Bactrim again this week and developed hives. Sulfa allergy is suspected.				Y					Y	10/19/1999	10/20/1999	1	NONE	PUB	PVT	NONE	NONE	seasonal allergies		2015	1						1	Hypersensitivity; Pharyngolaryngeal pain; Urticaria	FLU3~PFIZER\WYETH~4998278~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0150504	03/28/2000	SC	85.0	85		F	02/02/2000	Pt experienced a red, itchy area on left upper arm approximately the size of a 5 x 6 cm erythematous hot non tender area. No fluctuance, no streaks. MD prescribed erythromycin and Benadryl. Phone call to pt reports not taking prescription. Site healed.				Y					Y	10/21/1999	10/28/1999	7		PUB	PUB	NONE	NONE	allergy to PCN		SC00011	1						1	Injection site erythema; Injection site warmth; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0131AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TTOX~CONNAUGHT LABORATORIES~7341AA~UNK~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0150527	03/29/2000		19.0	19		M	03/05/2000	Large local reaction with paresthesia requiring Benadryl.									Y	02/25/2000	03/03/2000	7	NONE	MIL	MIL						1						1	Injection site reaction; Paraesthesia	ANTH~MICHIGAN DEPT PUB HLTH~FAV047~4~IM~RA~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|JEV~CONNAUGHT LABORATORIES~~3~SC~~JAPANESE ENCEPHALITIS (J-VAX)~1	USA		Influenza
0150538	03/29/2000	HI	24.0	24		F	02/28/2000	24 hours post vax, the pt developed hives/urticaria. Pt went to ER and was given Benadryl IM and sent home on oral Benadryl. Symptoms resolved completely in 2 days.				Y					Y	02/04/2000	02/04/2000	0	NONE	OTH	MIL	NONE	NONE	PCN - Allergy- Hives			1						1	Urticaria	ANTH~MICHIGAN DEPT PUB HLTH~FAV024~1~SC~~ANTHRAX (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~U0168AA~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0150607	03/30/2000	PA	3.0	2	.9	M	03/10/2000	Large eruption of skin over deltoid in region of vaccination for a several week duration. Treated with topical steroids.									Y	11/02/1999	11/04/1999	2	NONE	PVT	PVT		NONE	NONE			1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~U0111AB~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0150615	03/30/2000	MO	1.0	1	.2	F	03/13/2000										Y	03/08/2000	03/10/2000	2		PUB	PUB	PPD	NONE	NONE		MO2000019	1						1	Injection site erythema; Injection site mass; Nasal congestion; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~00669P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|VARCEL~MERCK & CO. INC.~1683J~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0150679	03/31/2000	FL	70.0	70		M	06/29/2005	Three days post vax, the pt's skin erupted in rash over most of the body with extreme itching. Treated with prednisone; which took the rash away but it returned within a few weeks.  Information received from medical records state anemia, hyperlipedemia.				Y				Y	N	11/15/1996	11/16/1996	1		OTH	PUB		NONE	NONE			1						1	Anaemia; Hyperlipidaemia; Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~4~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~~PNEUMO (NO BRAND NAME)~1	USA	Disabling	Influenza
0150749	04/04/2000	DE	33.0	33		M	03/28/2000	Pt experienced joint pain (lower body, wrist), and fatigue.									U	10/14/1999	10/15/1999	1	Chem, ANA, TSH	MIL	MIL	NONE	NONE	NONE			1						1	Arthralgia; Fatigue	ANTH~MICHIGAN DEPT PUB HLTH~FAV024~3~IM~LA~ANTHRAX (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~U0168AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0150764	04/05/2000	MO	24.0	23		F	03/30/2000	Flu-like symptoms following injection 11/1/99. Worsened 11/13/99 through 11/15/99. Paralysis 11/16/99. Dx with Transverse Myelitis.			Y	Y	Y	67	Y	Y	N	11/01/1999	11/16/1999	15	MRI, ECG, US liver, many blood tests, chest x-rays	PUB	OTH	Birth control pills	NONE	NONE			1						1	Influenza like illness; Myelitis transverse; Paralysis	FLU3~PARKDALE PHARMACEUTICALS~00199P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0150775	04/05/2000	CA	44.0	44		M	03/28/2000	Skin rashes over legs, arms and hips.									N	10/26/1998	12/01/1998	36	Skin biopsy	MIL	MIL		NONE	NONE			1						1	Rash	ANTH~MICHIGAN DEPT PUB HLTH~FAV030~1~SC~RA~ANTHRAX (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4988247~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0134667	04/06/2000	NJ	53.0	53		F	03/30/2000	Pt experienced swelling of the feet and hands with itching skin. Desquamation of plantar area.				Y					Y	11/26/1999	11/26/1999	0	unspecified test-neg	PUB	PVT	K-dur		allergy to PCN			1						2	Dermatitis exfoliative; Oedema peripheral; Pruritus; Dermatitis exfoliative; Oedema peripheral; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0159AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0159AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0150788	04/06/2000	MS	51.0	50		M	03/14/2000	Right arm has spot where shot was given that has continued to be sore and hurt since injection on 11/3/99. Denies redness or swelling. Area that's sore is size of postage stamp, according to patient.									N	11/03/1999	11/03/1999	0		PUB	PUB	NONE	NONE	NONE		MS00008	1						1	Injection site pain	FLU3~PFIZER\WYETH~4998232~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1584H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0150854	04/07/2000	WA	47.0	47		M	02/10/2000	Rash developed on neck and chest 3 days, post vax. Treated with oral steroids then Kenalog IM on 2/10/2000. Unknown outcome but to recheck on 10/17/2000.									Y	01/17/2000	01/20/2000	3		PVT	PUB		NONE			WA001643	1						1	Rash	FLU3~CONNAUGHT LABORATORIES~U0166AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~463726~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0150885	04/10/2000	DE	33.0	32		M	04/05/2000	Pt states, post vax, he started feeling light-headed, dizziness and nausea. The symptoms started after a couple of months. Also, noticed loss of weight. (loss 20 lbs). No active duty.									N	10/29/1999	03/01/2000	124	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Dizziness; Nausea; Weight decreased	ANTH~MICHIGAN DEPT PUB HLTH~FAV024~3~SC~~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0150996	04/19/2000					U	04/18/2000	A pharmacist reported that a pt received Flu Shield (1999-2000 formula) and subsequently developed Guillain Barre Syndrome. this event is considered medically important. No further information was available at the date of this report.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ3460217APR2000	1						1	Guillain-Barre syndrome	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0151015	04/19/2000	SC	35.0	34		M	03/30/2000	Knot, cherry-sized, swelling that lasted 3 months. Swelling in arm and bruise for 2 months after 2nd shot on 2/23/1999. Flu-like symptoms and headache, 2 weeks after 3rd shot, lasted 2 days and reportedly same 3 weeks later, shot given on 10/20/1999.									Y	11/14/1998	11/14/1998	0		MIL	MIL	Synthroid					1						1	Oedema; Skin nodule	ANTH~MICHIGAN DEPT PUB HLTH~FAV034~UNK~SC~~ANTHRAX (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~097170~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0151035	04/21/2000	LA	54.0	54		M	04/20/2000	An attorney reported that a 54 year old male, received an injection of Flu Shield (1998-1999 Formula) on 11/17/1998 and within 10 days, developed vomiting and diarrhea. He was seen by the MD on 11/30/1998. The reporter indicated that it was believed at that time that he had some type of virus. On 12/6/1998, the pt was admitted to the hospital due to general paralysis; he was unable to move his hands, arms or legs. The pt was paralyzed for months and was dx'd as suffering from Guillain-Barre Syndrome. He was transferred to a rehabilitation center on 12/22/1998 for long term rehabilitation. He was discharged on 6/30/1999 and received physical therapy at home for 4 to 6 weeks. The pt continues to be weak and disabled; he is unable to walk in a normal fashion and is only able to ambulate with the assistance of a stand-up walker for very short periods of time. The pt is only able to lift a few pounds of weight with either arm or hand. This report of a serious, labeled event is being submitted in a 15-day time frame, as requested.				Y	Y			Y	U	11/17/1998	11/27/1998	10	UNK	OTH	OTH	UNK	UNK	UNK		HQ3772219APR2000	1						1	Diarrhoea; Difficulty in walking; Guillain-Barre syndrome; Muscular weakness; Paralysis; Vomiting; Diarrhoea; Difficulty in walking; Guillain-Barre syndrome; Muscular weakness; Paralysis; Vomiting	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation,Disabling	Influenza
0151053	04/24/2000	WA	54.0	55		F	01/25/2000	Pt ached all over for several weeks then aches settled in upper back and shoulders. Didn't feel well, very tired. Saw MD on 1/11/00 and he offered the idea it was from the Hep B vaccine. Treated with Nuprin, aches were gone on 1/18/00.				Y					Y	12/08/1999	12/10/1999	2	NONE	PUB	PUB	Synthroid, Nuprin, hormones	NONE	allergy to PNC, Valium. hx of ingestion of ETOH, thyroid cancer, kidney stones		WA001640	1						1	Arthralgia; Back pain; Fatigue; Malaise; Pain	FLU3~PARKDALE PHARMACEUTICALS~02979P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~3066A4~1~IM~LA~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0151057	04/24/2000	NH	43.0	43		F	03/28/2000	Pt experienced immediate redness, warmth to left upper arm with bullae. Ongoing pain and inflammation. Still at the site 5 months later. Still being treated with steroid injections and topical meds. Being followed by MD.									N	10/19/1999	10/19/1999	0		PVT	OTH	Celebrex, Orthocept	NONE	NONE			1						1	Dermatitis bullous; Feeling hot; Injection site erythema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~5~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0151080	04/24/2000	WA	76.0	76		F	02/03/2000	Painful erythematous upper arm distal to injection site with subjective shortness of breath, marked anxiety, anorexia.				Y					U	02/01/2000	02/03/2000	2	NONE	PVT	PVT	Albuteral, calcium, multi vitamins, trimethsulfate, amacort	NONE	COPD		WA001644	1						1	Anorexia; Anxiety; Dyspnoea; Injection site pain	FLU3~PFIZER\WYETH~4998252~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0043J~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0131446	04/26/2000	IL	45.0	45		F	08/15/2002	It was reported that a female patient received a Fluzone Unspecified '99-00 vaccination on 10/28.99. Reportedly that same day, the patient developed an irregular heartbeat. The patient reports that she is 'still undergoing tests by the doctor. From additional information received 12/23/99, it was confirmed that the patient received a Fluzone  SV '99 -00 vaccination on 10/28/00. Within half a hour of the vaccination, the patient developed shortness of breath, chest heaviness and nausea. The patient was seen in the emergency room and follow-up was done by a cardiologist. From additional information received on 01/17/00, additional patient responsible physician and laboratory work information was provided. From additional correspondence received on 01/17/00, additional patient, responsible physician and laboratory work information was provided. From additional correspondence received on 01/24/00, it was reported that the patient also experienced, choking of the throat feeling, PVC's dizziness, almost and/or momentary blacking out and fainting  feeling, blurry vision, physical exhaustion  and temperature of 98.9 to 100.5 deg F. The patient also experienced some memory hardships with speech difficulties to relay thoughts. These episode occurred right after the shot and continue daily, along with periods of irregular (heart) beats.  The patients also experienced three episodes of sudden shaking and chills with a temperature of 96.5 to 97 deg F which occurred only days after the vaccination. Follow-up #1 (8/08/02: During internal auditing of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (added Larynismus, and deleted Convulsions). Also reranked adverse events.			Y	Y					U	10/28/1999	10/28/1999	0	blood work, chest x-ray, ECGs, Echocardiogram, Stress tests, Treadmill, More blood work, 'Kings of hearts monitor, Still tests ongoing	PVT	PVT		NONE	NKA		U1999-00996	1						1	Amnesia; Arrhythmia; Asthenia; Chest pain; Dizziness; Dyspnoea; Laryngospasm; Nausea; Pyrexia; Syncope; Testicular disorder; Visual disturbance; Amnesia; Arrhythmia; Asthenia; Chest pain; Dizziness; Dyspnoea; Laryngospasm; Nausea; Pyrexia; Syncope; Testicular disorder; Visual disturbance	FLU3~CONNAUGHT LABORATORIES~UO144AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~UO144AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening	Influenza
0131446	04/26/2000	IL	45.0	45		F	08/15/2002	It was reported that a female patient received a Fluzone Unspecified '99-00 vaccination on 10/28.99. Reportedly that same day, the patient developed an irregular heartbeat. The patient reports that she is 'still undergoing tests by the doctor. From additional information received 12/23/99, it was confirmed that the patient received a Fluzone  SV '99 -00 vaccination on 10/28/00. Within half a hour of the vaccination, the patient developed shortness of breath, chest heaviness and nausea. The patient was seen in the emergency room and follow-up was done by a cardiologist. From additional information received on 01/17/00, additional patient responsible physician and laboratory work information was provided. From additional correspondence received on 01/17/00, additional patient, responsible physician and laboratory work information was provided. From additional correspondence received on 01/24/00, it was reported that the patient also experienced, choking of the throat feeling, PVC's dizziness, almost and/or momentary blacking out and fainting  feeling, blurry vision, physical exhaustion  and temperature of 98.9 to 100.5 deg F. The patient also experienced some memory hardships with speech difficulties to relay thoughts. These episode occurred right after the shot and continue daily, along with periods of irregular (heart) beats.  The patients also experienced three episodes of sudden shaking and chills with a temperature of 96.5 to 97 deg F which occurred only days after the vaccination. Follow-up #1 (8/08/02: During internal auditing of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (added Larynismus, and deleted Convulsions). Also reranked adverse events.			Y	Y					U	10/28/1999	10/28/1999	0	blood work, chest x-ray, ECGs, Echocardiogram, Stress tests, Treadmill, More blood work, 'Kings of hearts monitor, Still tests ongoing	PVT	PVT		NONE	NKA		U1999-00996	1						2	Amnesia; Arrhythmia; Asthenia; Chest pain; Dizziness; Dyspnoea; Laryngospasm; Nausea; Pyrexia; Syncope; Testicular disorder; Visual disturbance; Amnesia; Arrhythmia; Asthenia; Chest pain; Dizziness; Dyspnoea; Laryngospasm; Nausea; Pyrexia; Syncope; Testicular disorder; Visual disturbance	FLU3~CONNAUGHT LABORATORIES~UO144AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~UO144AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening	Influenza
0134630	04/26/2000	SC				F	03/08/2000	She believes vaccine caused this. Vaccinated on 12/8/1999. On 12/27/1999, lost use of her legs, bowels shutdown and went to ER. They sent her home in wheelchair. No dx. Went to MD on 12/28/1999, who sent her to hospital and was admitted. (Neurologist) dx Guillain-Barre Syndrome. She now has nerve damage and paralysis.					Y	5		Y	N	12/08/1999	12/27/1999	19		UNK	UNK						1						2	Guillain-Barre syndrome; Myasthenic syndrome; Neuropathy; Urinary incontinence; Guillain-Barre syndrome; Nerve injury; Paralysis	FLUX~UNKNOWN MANUFACTURER~G0008~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~G0008~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation,Disabling	Influenza
0151099	04/26/2000	MA	66.0	66		F	04/25/2000	The following February post vax, pt developed various viral infections and was hospitalized.					Y				U	09/01/1993	02/01/1994	153	UNK	PUB	PUB	Amaryl, Bumex, Corgard, Cozaar, potassium, Prilosec, Reglan, Ziac	NONE	UNK		HQ4000121APR2000	1						1	Viral infection	FLU3~PFIZER\WYETH~~5~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0151676	05/08/2000	CT	26.0	25		F	04/03/2000	Pt complaining of rash on extremities, hot to touch, itchy, and bumpy liquid filled pustules 1-2mm in diameter. Rash is clustered and confined to the extremities. It has been evident for approximately 1 year following initial Anthrax IZ. Rash is intermittent and varying in severity.									N	11/07/1998	04/01/1999	145	UNK	MIL	MIL	BC, Allergy shots	UNK	Seasonal hay fever.	Local pain malaise~Typhoid Vi Polysaccharide (no brand name)~2~21.00~In Patient		1						1	Dermatitis bullous; Pruritus; Vasodilation procedure	ANTH~MICHIGAN DEPT PUB HLTH~FAV030~1~SC~~ANTHRAX (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~U0135A~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0151797	05/10/2000	FL	53.0			F	05/09/2000	A husband reported that his wife received vax on 11/19/99. Two days post vax, she developed nodules in her fatty tissue over her entire body. A biopsy of the nodules reportedly revealed that they were benign. Follow-up information received from the physician provided that the biopsy revealed T-cell lymphoma. The physician does not feel that the lymphoma was caused or aggravated by the vax administration. He stated that 'it was just a coincidence' and 'not at all related' to the vax. Additional info received on follow-up from the physician on 04/08/2002 indicated thatt he pt partially recovered. She was treated for T-cell lymphoma and that the number of nodules was decreased from 20 to 2. The pt did not have follow-up with the physician since 05/19/2000.									N	11/19/1999	12/01/1999	12	Biopsy NOS - non-malignant nodules, however, follow-up information from physician indicated the biopsy revealed T-cell lymphoma.	PVT	OTH	Vasoretic	NONE	T-cell lymphoma (NOS)		HQ1061214FEB2000	1						1	Lymphoma; Subcutaneous nodule; Skin nodule	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PARKDALE PHARMACEUTICALS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0151799	05/10/2000	OR	44.0			M	04/28/2000	This case concerns male who had had influenza vax 48 hours prior to chemotherapy. On day 3, after the carboplatin based tridrug chemotherapy with blood brain-barrier disruption (vertebral artery), he experienced respiratory arrest and rapid progression of quadriparesis. The pt remained quadriparetic and ventilator dependent and died 75 days after chemotherapy treatment. The authors conclude that the pathophysiology of the complication seen in the 7 pts is multi-factorial but may be related to vascular streaming and an atypical inflammatory toxic reaction to carboplatin or etoposide. The complication has not recurred during a 6 month period following modification of the protocol. Date of vax and onset not specified and therefore assumed to be associated with the 1999/1999 influenza season.	Y				Y				N	10/01/1999	10/05/1999	4	probable cause of death-progression of tumor and respiratory failure	OTH	OTH	Carboplatin, etoposide phosphate, cyclophosphamide.		glioblastoma multiforme located in occipital region		MPU2000002450	1						1	Neoplasm; Quadriplegia; Respiratory arrest; Respiratory failure	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0151861	05/12/2000	OR				F		About 45 mins post vax, pt became nauseated, vomiting, chilling perspiring, anxious and pale. Symptoms continued with no decrease or increase. Adrenaline was given, anxiety decreased, nausea and vomiting, chilling decreased. Color and strength returned. Pt had not eaten breakfast. Recommended she consult her private health care provider. Family member called.				Y					Y	10/01/1999	10/01/1999	0	BP-12/68, P-62	OTH	PVT						1						1	Anxiety; Chills; Hyperhidrosis; Hypotension; Nausea; Pallor; Vomiting	FLU3~PFIZER\WYETH~4998233~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0151937	05/15/2000		26.0	26		M	05/03/2000	Pt experienced swollen, hot, red arm 22 x 12 cm. Arm also itches and hurts. No systemic symptoms, no lost duty time.				Y					U	05/01/2000	05/02/2000	1	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Feeling hot; Injection site erythema; Injection site pain; Injection site swelling; Pruritus	ANTH~EMERGENT BIOSOLUTIONS~FAV047~6~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~PFIZER\WYETH~4998234~3~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|MEN~UNKNOWN MANUFACTURER~1001590~2~~LA~MENINGOCOCCAL (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0132008	05/17/2000	CA	44.0	44		F	10/28/1999	Deep in my arm pit-almost chest area of left side (same as injection), extremely tender. Hurts/aches all the time. Hurts to raise arm overhead x 4 days. Tightness, left lwr back-spasm. Has a Dr's appt 11/2/99. Labs drawn 11/4/99.									N	10/23/1999	10/24/1999	1	NONE	PVT	PVT	Orthotricycline-birth control  ASA	NONE	Heart: MVP	~ ()~~~In patient		1						1	Back pain; Hypertonia; Hypokinesia; Lymphadenopathy; Pain; Back pain; Hypertonia; Hypokinesia; Lymphadenopathy; Pain; Flank pain; Hypokinesia; Muscle spasms; Musculoskeletal discomfort; Pain	FLU3~CONNAUGHT LABORATORIES~02189P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~02189P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~02189P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA		Influenza
0132008	05/17/2000	CA	44.0	44		F	10/28/1999	Deep in my arm pit-almost chest area of left side (same as injection), extremely tender. Hurts/aches all the time. Hurts to raise arm overhead x 4 days. Tightness, left lwr back-spasm. Has a Dr's appt 11/2/99. Labs drawn 11/4/99.									N	10/23/1999	10/24/1999	1	NONE	PVT	PVT	Orthotricycline-birth control  ASA	NONE	Heart: MVP	~ ()~~~In patient		1						2	Back pain; Hypertonia; Hypokinesia; Lymphadenopathy; Pain; Back pain; Hypertonia; Hypokinesia; Lymphadenopathy; Pain; Flank pain; Hypokinesia; Muscle spasms; Musculoskeletal discomfort; Pain	FLU3~CONNAUGHT LABORATORIES~02189P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~02189P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~02189P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA		Influenza
0152013	05/17/2000	TX	58.0	58		F	05/25/2000	Report received from a neurologist concerning a pt who experienced peripheral neuropathy 5 days post vax. Reported date of vax and reaction start date were approximate. Case reassessed to be serious on receipt of follow-up information form the neurologist. This pt developed neuropathy and loss of coordination and reflex strength. The vaccinee was also reported as 'dysesthetic poor'. The vaccinee was treated with steroids. Symptoms were stated by the reporter to be disabling/incapacitating. No stop date was given for the symptoms. Numerous labs and tests were consistent with neuropathy.				Y				Y	N	11/10/1999	11/15/1999	5	Electromyography, lumbar puncture - both consistent with neuropathy.	PVT	OTH	NONE		History of glaucoma, hypothyroidism and a hysterectory.		MPU2000000540	1						1	Asthenia; Coordination abnormal; Neuropathy; Neuropathy peripheral	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0152079	05/18/2000	MA	53.0	53		F	03/07/2000	The pt received the influenza virus vax in 11/1998 and subsequently experienced muscle pain all over with weakness, total exhaustion and difficulty sleeping around 12/1998. The pt noted 'can't make it up a flight of stairs.' Additional information has been requested.				Y					U	11/01/1998	12/01/1998	30		OTH	OTH			UNK		WAES99032062	1						1	Asthenia; Fatigue; Myalgia; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~MERCK & CO. INC.~~3~~~HEP B (RECOMBIVAX HB)~1	USA	Emergency room visit	Influenza
0152202	05/22/2000	AZ	11.0			F	05/19/2000	It was reported that an 11-year old female pt received a flu vaccination. Two days after the vax the pt's feet started to go to sleep then her legs. The pt began having spasms in her back which have progressed severely to the point of becoming confined to a wheelchair. Further information requested.								Y	U	10/01/1999	10/03/1999	2		UNK	UNK					U2000003460	1						1	Hypoaesthesia; Muscle spasms	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0152204	05/22/2000	MN	41.0	41		F	05/11/2000	Pt was immunized with a flu vaccine on 11/13/99. Pt was hospitalized and diagnosed with Guillain Barre syndrome 11/21/99. Pt is still on disability. Annual follow up states patient has difficulty moving hands, is very clumsy and easily drops items. Patients legs are achy and weak and there is tingling in feet.  Patient cannot run with ease and is fatigued.				Y	Y	6			N	11/13/1999	11/17/1999	4	Spinal tap, EMG	OTH	PVT						1						1	Asthenia; Clumsiness; Fatigue; Guillain-Barre syndrome; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0152233	05/23/2000	AR	19.0	19		F	11/29/1999	Within 3 minutes of receiving Influenza injection, pt's left arm became reddened and edematous from elbow to shoulder, then spreading across chest and up to face. Pt then began wheezing respirations. Pt left facility within 5 minutes to go to MD's office where she received one epinephrine injection.				Y					Y	11/22/1999	11/22/1999	0		OTH	OTH	Aerobid, Serovent, Orthocycen, Albuterol	NONE	Asthma		AR0002	1						1	Injection site erythema; Injection site oedema; Wheezing	FLU3~SANOFI PASTEUR~U0165AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0152307	05/24/2000		25.0			M	05/22/2000	This vaccinee, post vax, developed systemic lupus erythematous after receiving influenza vaccine, typhoid vaccine, meningococcal vaccine, tetanus vaccine and Immune serum globulin. He had not received any drugs known to induce SLE prior to vaccination. Treatment regiment included corticosteroids, cyclophosphamide, hydromycholoroqune and azathioprine. He continued to experience residual symptoms for up to 7 years of follow-up. Per doc no 199371, annual follow up, no further information received as of september 2001.				Y					U					OTH	OTH	NONE				MPU2000002750	1						1	Systemic lupus erythematosus	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~UNK~~~MENINGOCOCCAL (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0152308	05/24/2000		31.0			M	05/22/2000	This vaccinee, with no symptoms of connective tissue disease prior to vaccination, developed systemic lupus erythematous after receiving influenza vaccine, typhoid, meningococcal and tetanus vaccine and immune serum globulin. He had not received any drugs known to induce SLE prior to vaccination. Treatment included corticosteroids, cyclophosphamide, hydroxychloroquine and azathiprine. He continued to experience residual symptoms for up to 7 years of follow-up. Date of influenza vaccination and onset date of adverse event, not specified therefore associated with 1999/2000 season.				Y					N	10/01/1999	10/01/1999	0		OTH	OTH	NONE				MPU2000002760	1						1	Systemic lupus erythematosus	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~UNK~~~MENINGOCOCCAL (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~~TETANUS TOXOID (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~SC~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0152309	05/24/2000		33.0			F	05/22/2000	This vaccinee with no symptoms of connective tissue disease prior to vaccination, developed systemic lupus erythematous, after receiving influenza, MMR, typhoid, meningococcal, tetanus and diptheria and oral polio vaccine. She had not received any drugs known to induce SLE prior to vaccination. Treatment included corticosteroids, cyclophosphamide, hydroxychloroquine and azathiprine. She continued to experience residual symptoms for up to 7 years of follow-up.				Y					N	10/01/1999	10/01/1999	0		OTH	OTH	NONE				MPU2000002770	1						1	Systemic lupus erythematosus	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~UNK~~~MENINGOCOCCAL (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0152383	05/25/2000	AL	26.0	26		F	04/04/2000	Pt experienced left arm discoloration, loss of muscle tissue occurred, some stinging/tingling sensation occur regularly. Lidocaine was prescribed.									U	11/12/1999	11/26/1999	14		OTH	OTH	NONE	NONE	NONE			1						1	Muscle disorder; Pain; Paraesthesia; Skin discolouration	FLU3~PFIZER\WYETH~4998276~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0152420	05/26/2000	WV	66.0	66		M	05/11/2000	On 10/14/99, the pt received a flu vaccine and a pneumococcal vaccine and 4 - 5 minutes post vax, the pt suffered a bleeding stroke and was sent to the hospital. The pt remained in the hospital for 7 weeks and is still in rehabilitation. The pt was told that he was the fourth pt admitted to the hospital with a stroke after receiving the flu vaccine. There was a recall of three county areas (outdated) while the pt was in the hospital. Additional information per call to reporter 5/10/2000. At the time of the incident the reporter was 66 years old and in good health. He received a flu vaccine and a pneumococcal vaccine. he contacted the facility where he received to get the manufacturers names and was told that the manufacturers vary; he was given a lot number of 456690, but does not know which product it is for.					Y	49			Y	10/14/1999	10/14/1999	0		UNK	UNK						1						1	Cerebrovascular accident	FLU3~PFIZER\WYETH~499827~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~456690~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0152465	05/26/2000	WI	53.0	53		F	04/05/2000	Numbness and weakness of left arm after injection, lasting for about one month.									Y	10/04/1999	10/05/1999	1	NONE	OTH	OTH	Estrace, synthroid, Atenolol, Naproxen, Doxepin	NONE	Macnodantin allergy			1						1	Hypoaesthesia; Muscular weakness	FLU3~PFIZER\WYETH~4998229~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0152492	05/26/2000	PA	73.0	73		F	04/05/2000	Pt experienced vomiting and diarrhea first night post vax only. Pt complained of headaches, sleeping allot each day (usually very active, hardly ever ill), developed tremors especially hands could hardly write. Would think he was better, then would regress again. Pt had general malaise most of the time.									Y	01/07/2000	01/08/2000	1		PVT	PVT		sinusitis				1						1	Diarrhoea; Headache; Malaise; Somnolence; Tremor; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0157AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0129985	06/01/2000	IN	48.0	48		F	10/19/1999	pt c/o redness, pain & swelling @ inj site >usual;MD observed;									Y	10/04/1999	10/07/1999	3		PVT	UNK	Humulin 70/30;PPD by Connaught lot# 0277P given 10/4/99;	diabetic elevated BS	PCn, codiene, cephalosporins	~ ()~~~In patient		1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~458743~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~248811~UNK~~LA~PNEUMO (PNU-IMUNE)~1|FLU3~PARKDALE PHARMACEUTICALS~458743~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~PFIZER\WYETH~248811~UNK~~LA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0129985	06/01/2000	IN	48.0	48		F	10/19/1999	pt c/o redness, pain & swelling @ inj site >usual;MD observed;									Y	10/04/1999	10/07/1999	3		PVT	UNK	Humulin 70/30;PPD by Connaught lot# 0277P given 10/4/99;	diabetic elevated BS	PCn, codiene, cephalosporins	~ ()~~~In patient		1						2	Injection site hypersensitivity; Injection site oedema; Injection site pain; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~458743~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~248811~UNK~~LA~PNEUMO (PNU-IMUNE)~1|FLU3~PARKDALE PHARMACEUTICALS~458743~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~PFIZER\WYETH~248811~UNK~~LA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0152567	06/01/2000	MA	27.0	27		M	02/23/2000	Optic neuritis in right eye, numbness in legs, and blurry vision in right eye. Treated with Solu-Medrol. Numbness was gone in a week but blurry vision has not changed on 5/13/00. Annual follow up states blurred vision in right eye. Per F/U 7/24/00; also treated with Methyl Prednisone. Pt also had a headache and pain with eye movement.				Y	Y	6		Y	N	11/08/1999	11/11/1999	3	MRI, blood work, UA, LP	PVT	PVT	Claritin; Beclovent; tetracycline	NONE	NONE			1						1	Eye pain; Headache; Hypoaesthesia; Optic neuritis; Vision blurred	FLU3~SANOFI PASTEUR~U0187~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0152652	06/05/2000	WV	74.0			F	05/30/2000	Reportedly on 11/5/99, the pt experienced congestive heart failure and kidney shut down on 11/5 or 11/6/99. The pt was hospitalized and required heart surgery. The pt was discharged from the hospital on 12/9/1999.					Y				Y	10/06/1999	11/05/1999	30		UNK	UNK	Glucophage 150mg twice daily, Lanoxin 125mg once daily, Amaryl		diabetes, lung cancer		U2000003840	1						1	Cardiac failure congestive; Renal impairment	FLU3~CONNAUGHT LABORATORIES~U0108AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0104388	06/07/2000	MD	49.0	49		F	09/08/1998	It was reported that a 49 year old female who, the next day post vax, experienced a large reddened area of the left upper arm. Measures approximately 3-4 in width. She developed left arm stiffness which spread to left upper back and left side of neck. Stated she could not lay on her left side and could not lift left arm very high. Complained of aching deep inside of left upper arm. Seen by PMD on 10/28/1997, no treatment. From follow-up on 9/8/1998, it was reported that the pt recovered from this experience.				Y					Y	10/24/1997	10/25/1997	1	NONE	PUB	PUB	NONE	NONE	Novocaine and Nitrous oxide allergies		U1998002710	1						2	Hypokinesia; Injection site erythema; Musculoskeletal stiffness; Pain	FLU3~CONNAUGHT LABORATORIES~7F81791~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0130974	06/07/2000	WA				U	11/11/1999	The pt experienced soreness at the injection site that lasted for 24 hours.									Y	10/04/1999	10/04/1999	0	UNK	UNK	UNK	UNK	UNK	UNK		FLU2061199	1						3	Arthralgia; Myalgia; Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~1889P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2|FLU3~PARKDALE PHARMACEUTICALS~02879P~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~3	USA		Influenza
0152698	06/07/2000	NY	65.0	65		F	09/03/1999	Pt complained of myalagia, aches and pain all over as well as a fever of 102.2. Pt continues to have fever, aches and pain.				Y					N	09/02/1999	09/02/1999	0	NONE	PUB	PVT	atenolol 50 mg	NONE	NONE		FLU1010999	1						1	Myalgia; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~01789P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0152699	06/07/2000	VA	29.0	29		F	10/12/1999	Pt complained that shot burned and stung injection site upon receipt.  The next day the area was sore, hot to touch and extremely red and swollen, also had a hard knot subside symptoms.									Y	10/01/1999	10/02/1999	1		PVT	OTH		NONE	NONE		FLU1031099	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Vasodilation procedure	FLU3~PARKDALE PHARMACEUTICALS~01889P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0152700	06/07/2000	VA				F	10/12/1999	Pt complained that injection site was hot to touch, swollen and red.									Y	10/01/1999	10/02/1999	1		PVT	PVT		NONE	NONE		FLU1051099	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilation procedure	FLU3~PARKDALE PHARMACEUTICALS~01889P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0152701	06/07/2000	OH	50.0	50		F	11/05/1999	2-1/2-3 raised red area at site. Hot to touch, tender, firm. Complained of headache.									U	10/06/1999	10/08/1999	2		OTH	PVT		NONE	NONE		FLU1121199	1						1	Headache; Injection site pain; Injection site swelling; Vasodilation procedure	FLU3~PARKDALE PHARMACEUTICALS~02779P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0152702	06/07/2000	OH	42.0	42		F	11/05/1999	2-1/2 diameter raised red area on upper arm at injection site. Hot to touch, tender, firm, and complained of headache.									U	10/07/1999	10/08/1999	1	NONE	OTH	OTH		NONE	NONE		FLU1131199	1						1	Headache; Injection site pain; Injection site swelling; Vasodilation procedure	FLU3~PARKDALE PHARMACEUTICALS~02779P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0152703	06/07/2000	OH				F	11/05/1999	2-1/2-3  diameter raised red areas on upper arm at injection site. Hot to touch, tender, and firm.									Y	10/07/1999	10/08/1999	1	NONE	OTH	OTH		NONE	NONE		FLU1141199	1						1	Injection site pain; Injection site swelling; Vasodilation procedure	FLU3~PARKDALE PHARMACEUTICALS~02779P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0152704	06/07/2000	OH	50.0	51		F	11/05/1999	Redness at injection site and hot to touch.									U	10/06/1999	10/07/1999	1		OTH	OTH		NONE	NONE		FLU1151199	1						1	Injection site hypersensitivity; Vasodilation procedure	FLU3~PARKDALE PHARMACEUTICALS~02779P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0152705	06/07/2000	OH	54.0	54		F	11/08/1999	Redness, itching and warmth at the injection site.									U	10/06/1999	10/06/1999	0		OTH	OTH		NONE	NONE		FLU1181199	1						1	Injection site hypersensitivity; Pruritus; Vasodilation procedure	FLU3~PARKDALE PHARMACEUTICALS~02779P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0152706	06/07/2000	MD	68.0	67		F	11/08/1999	The pt reported an injection site reaction administered 10/20/1998.									Y	10/20/1998			UNK	OTH	OTH	UNK	UNK	UNK		FLU1191199	1						1	Injection site reaction	FLU3~PARKDALE PHARMACEUTICALS~02189P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0152707	06/07/2000	CT	45.0	44		F	11/08/1999	48 hours post vaccine the pt complained of a fever, chills, fatigue and malaise that lasted (2) days.									Y	10/04/1999	10/05/1999	1	NONE	PUB	OTH	UNK	NONE	NONE		FLU1201199	1						1	Fatigue; Malaise; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~03079P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0152708	06/07/2000	NY	32.0	32		M	11/05/1999	The pt developed flu-like symptoms approximately 48 hours after administration of flu-vaccine. The pt complained of malaise, fatigue, fever lasting from 10/10/99 - 10/15/99.									Y	10/08/1999	10/10/1999	2		OTH	PVT	NONE	NONE	NONE		FLU1211199	1						1	Fatigue; Influenza like illness; Malaise; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~03079P~1~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0152709	06/07/2000	GA	29.0	29		F	11/09/1999	The pt experienced itching and a small blister (vesicle) approximately 3cm from injection site. Today (10-26) another mm itchy area - 2cm from injection site may be another vesicle developing.									U	10/25/1999	10/25/1999	0	NONE	OTH	PUB	UNK	NONE	allergy to fire ants, grass, pine, pollen		FLU1221199	1						1	Blister; Injection site hypersensitivity; Pruritus	FLU3~PARKDALE PHARMACEUTICALS~02979P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0152710	06/07/2000	NJ	47.0			F	11/09/1999	Reported low grade fever, aching fingers, aching neck and hands (unable to make fist), extreme fatigue. Complained flu-like symptoms.									Y	10/13/1999	10/25/1999	12	UNK	OTH	OTH	UNK	NONE	hypertension, mitral valve prolapse		FLU12321199	1						1	Fatigue; Influenza like illness; Pain; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~01889P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0152711	06/07/2000	OH	67.0			F	11/09/1999	The pt reported a rectangle patch 8 cm x 4 cm that was red, hot to touch, edematous and recovered within 2 days.									Y	10/06/1999	10/08/1999	2		PVT	PVT	NONE	NONE	allergy to PCN		FLU1241199	1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~PARKDALE PHARMACEUTICALS~02879P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0152713	06/07/2000	CT	39.0	39		F	11/09/1999	It was reported that the pt experienced pain at injection site, discomfort to left arm, sweating at night, feeling hot and cold that has lasted for a week after the flu shot was administered.				Y					Y	10/08/1999	10/09/1999	1	NONE	OTH	PUB	NONE	NONE	NONE		FLU1251199	1						1	Feeling cold; Feeling hot; Hyperhidrosis; Injection site pain; Pain	FLU3~PARKDALE PHARMACEUTICALS~03079P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0152714	06/07/2000	OH	56.0			F	11/09/1999	The pt experienced erythema, edema but no heat below the injection site.									Y	10/06/1999	10/08/1999	2	NONE	OTH	OTH	NONE	NONE	allergy to sulfa		FLU211199	1						1	Erythema; Oedema	FLU3~PARKDALE PHARMACEUTICALS~02879P~1~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0152716	06/07/2000	CA	48.0	48		F	11/12/1999	The pt experienced fatigue, muscle ache, fever of 104 degrees. No complaints of headache or respiratory problems. The reaction lasted for 1 day.									Y	10/12/1999	10/12/1999	0	NONE	PVT	PVT	UNK	UNK	UNK		FLU2101199	1						1	Fatigue; Myalgia; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~02679P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0152717	06/07/2000	CA	40.0			M	11/15/1999	The pt experienced a fever of 102 degrees and a severe headache and aching all over that lasted for 48 hours.									Y	10/26/1999	10/26/1999	0	NONE	PVT	PVT	NONE	NONE	NONE		FLU2121199	1						1	Headache; Pain; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~02679P~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0152718	06/07/2000	HI	52.0	51		F	11/18/1999	The pt experienced an allergic reaction that included redness, and itching. (left arm)									Y	09/01/1999	09/01/1999	0	NONE	PVT	PVT	NONE	NONE	NONE		FLU2221199	1						1	Hypersensitivity; Injection site erythema; Pruritus	FLU3~PARKDALE PHARMACEUTICALS~~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0152726	06/07/2000	NY				F		Four days post vax, the pt complained of a funny feeling in the arm into which the vaccinee was injected. The symptoms progressed to weakness in the injection arm, which persisted as of 7/19/99. The pt was seen by a neurologist.				Y					N	11/01/1997	11/01/1997	0	UNK	PVT	OTH	UNK	UNK	UNK		899201192A	1						1	Muscular weakness	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0152735	06/07/2000	NY	16.0	16		M	06/01/2000	On 1/26/00, the pt experienced a grapefruit sized welt at the injection site. On 1/27/00, the pt developed a 101 fever that the reporter felt may be due to influenza virus vaccine. The pt was treated with Benadryl by mouth and cream and ice packs were applied to the welt. Follow-up information from a registered pharmacist indicated that approximately 2 weeks post onset the pt recovered. The pt had been in a 6 week rehab program and the welt at the site of injection did not prolong his stay. The pharmacist stated that the main obstacle in determining what caused the reaction was that the pt had received both the pneumococcal and influenza vax in the same arm.									Y	01/26/2000	01/27/2000	1		PUB	PUB					WAES00052387	1						1	Injection site urticaria; Pyrexia	FLU3~PFIZER\WYETH~4998261~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1102J~UNK~~RL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0152749	06/07/2000	CA	48.0	48		F	12/16/1998	On 10/22/98, the pt experienced arthralgia and myalgia. From additional information received on 11/30/98, it was reported that as of 11/13/98 the pt has not yet recovered, the symptoms are persistent. From additional information received on 12/15/98, it was reported that the pt's signs and symptoms had subsided on 12/8/98.									Y	10/20/1998	10/22/1998	2	NONE	PUB	PUB	Synthroid, Maxide, hormone replacement therapy	NONE	Hypothyroidism, allergy to Tetanus	cellulitis~Td Adsorbed (no brand name)~2~22.00~In Patient	U1998008120	1						1	Arthralgia; Myalgia	FLU3~CONNAUGHT LABORATORIES~0977170~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152750	06/07/2000	NY	60.0	60		F	11/24/1998	It was reported that a 60 year old female, immediately post vax, started with achy, sore left arm of vaccination and spread to both arms. She had chills, wheezing, loss of appetite and fatigue. Doctor treated her with anti-inflamatories which alleviated symptoms initially but symptoms still exist. They checked out her heart and everything looked ok. It is a month later and symptoms are still there.				Y					N	10/23/1998	10/23/1998	0		UNK	UNK					U1998008430	1						1	Anorexia; Chills; Fatigue; Injection site pain; Wheezing	FLU3~CONNAUGHT LABORATORIES~0972920~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0152751	06/07/2000	IA	59.0	59		M	08/21/2001	It was reported, that a 59 year old male, post vax, approximately 1-2 weeks later, had a rash appear at injection site. It was a very slight rash which became itchy. About the same time, the pt developed an achy arm, shoulder and neck. The pt went back to the MD, one month later and was told that the vaccine had nothing to do with his pain. The pt had an MRI and was followed-up through another MD, but they (reportedly) cannot find anything (no significant additional findings were made). From additional information received, on 4/29/1999, it was reported, that the pt has not yet recovered from this experience. From follow-up info received on 04/19/2001, it was reported that the pt has not recovered. In addition, reporter and responsible physician information were also provided. No further information was provided from follow-up #2 corespondence returned to Aventis Pasteur Inc. On 08/20/01. No further information is anticipated, this case is closed.				Y					N	11/02/1998	11/09/1998	7	MRI-nml	PVT	PVT		NONE	Pollen type-hay fever		U1999002330	1						1	Hypersensitivity; Pain; Pruritus	FLU3~CONNAUGHT LABORATORIES~0968420~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0152752	06/07/2000	MO	26.0	26		F	06/14/1999	A 26 year old female was vaccinated with Fluzone 96-97 on 11/19/1996. On 11/21/1996 it was reported that she had developed Bell's Palsy. From follow up of 2/19/97, it was reported that the pt had a past medical hx of obesity and asthma. The pt's recovery status was unknown.  From follow-up information received on 6/14/99, it was reported the pt's recovery status unknown.									U	11/19/1996	11/21/1996	2		UNK	UNK					70351	1						1	Facial palsy	FLU3~CONNAUGHT LABORATORIES~6F71227~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152754	06/07/2000	NJ	23.0	22		F	08/18/1998	It was reported, Pt stated that within 20 minutes, post vax, her throat closed. She said she complained of itching in throat area at first, then roof of mouth felt heavy. RN at MD's office read on chart-swollen throat, anaphylaxis within seven minutes, post vax. Pt was given Prelone and Benadryl at time of treatment. Reportedly the pt recovered from this experience.									Y	09/30/1997	09/30/1997	0	NONE	PVT	PVT	NONE	NONE	asthma, at age 22, the pt received a Flu-Fluzone unspecified in 1996 and 1997 and experienced itching under her skin, at injection site.		U1998004760	1						1	Anaphylactic reaction; Pruritus; Throat tightness	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152756	06/07/2000	TX	50.0	50		F	10/30/1998	It was reported that a 50 year old female pt, a few hours post vax, complained of thick tongue sensation (left side of tongue), no numbness. The pt was not evaluated by a MD. From additional information received on 10/30/1998, it was reported that the pt improved in 24 hours and fully recovered within 4 days.									Y	09/25/1998	09/25/1998	0		PVT	PVT	methotrexate	NONE	psoriasis		U1998005640	1						1	Tongue disorder	FLU3~CONNAUGHT LABORATORIES~0973920~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152757	06/07/2000	MD	85.0	85		F	09/29/1998	It was reported that an 85 year old female pt, post vax, reportedly on 9/25/1998, experienced generalized urticaria.									U	09/24/1998	09/25/1998	1		UNK	UNK					U1998005680	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~0966960~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152758	06/07/2000	MD	66.0	66		F	09/29/1998	It was reported that a 66 year old female pt, post vax, experienced facial edema.									U	09/24/1998	09/25/1998	1		UNK	UNK					U1998005690	1						1	Face oedema	FLU3~CONNAUGHT LABORATORIES~0966960~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152760	06/07/2000	CA	56.0			F	11/06/1998	It was reported that a 56 year old female received Fluzone 98-99 on 10/9/98. Reportedly the pt experienced large red area 4 inches in diameter at the injection site, also experienced pain and swelling since administration.									U	10/09/1998	10/09/1998	0		UNK	UNK		NONE	NONE		U1998006000	1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0968420~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152761	06/07/2000	MI				U	10/13/1998	It was reported that a pt (1 of 4) complained of redness and rash 3-4 inches in diameter after receiving the 98-99 Fluzone.									U					UNK	UNK					U1998006020	1						1	Injection site rash	FLU3~CONNAUGHT LABORATORIES~0973920~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152762	06/07/2000	MI				U	10/13/1998	It was reported that a pt (2 of 4) complained of redness and rash 3-4 inches in diameter after receiving the 98-99 Fluzone.									U					UNK	UNK					U1998006030	1						1	Injection site rash	FLU3~CONNAUGHT LABORATORIES~0973920~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152763	06/07/2000	MI				U	10/13/1998	It was reported that a pt (3 of 4) complained of redness and rash 3-4 inches in diameter after receiving the 98-99 Fluzone.									U					UNK	UNK					U1998006040	1						1	Injection site rash	FLU3~CONNAUGHT LABORATORIES~0973920~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152764	06/07/2000	MI				U	10/13/1998	It was reported that a pt (4 of 4) complained of redness and rash 3-4 inches in diameter after receiving the 98-99 Fluzone.									U					UNK	UNK					U1998006050	1						1	Injection site rash	FLU3~CONNAUGHT LABORATORIES~0973920~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152765	06/07/2000	NY				U	10/13/1998	Post vax, the pt experienced vomiting and diarrhea.									U	10/03/1998	10/08/1998	5		UNK	UNK					U1998006070	1						1	Diarrhoea; Vomiting	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152766	06/07/2000	NY				U	10/13/1998	It was reported that a pt (2 of 7) received Fluzone 98-99 between 10/3/98 and 10/6/98. Reportedly the pt experienced vomiting and diarrhea.									U	10/03/1998	10/08/1998	5		UNK	UNK					U199800608	1						1	Diarrhoea; Vomiting	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152767	06/07/2000	NY				U	10/13/1998	It was reported that a pt (3 of 7) received Fluzone 98-99 between 10/3/98 and 10/6/98. Reportedly the pt experienced vomiting and diarrhea.									U	10/03/1998	10/08/1998	5		UNK	UNK					U1998006090	1						1	Diarrhoea; Vomiting	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152768	06/07/2000	NY				U	10/13/1998	It was reported that a pt (4 of 7) received Fluzone 98-99 between 10/3/98 and 10/6/98. Reportedly the pt experienced vomiting and diarrhea.									U	10/03/1998	10/08/1998	5		UNK	UNK					U1998006100	1						1	Diarrhoea; Vomiting	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152769	06/07/2000	NY				U	10/13/1998	It was reported that a pt (5 of 7) received Fluzone 98-99 between 10/3/98 and 10/6/98. Reportedly the pt experienced vomiting and diarrhea.									U	10/03/1998	10/08/1998	5		UNK	UNK					U1998006110	1						1	Diarrhoea; Vomiting	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152770	06/07/2000	NY				U	10/13/1998	Post vax, pt experienced vomiting and diarrhea.									U	10/03/1998	10/08/1998	5		UNK	UNK					U1998006120	1						1	Diarrhoea; Vomiting	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152771	06/07/2000	NY				U	10/13/1998	Post vax, the pt experienced vomiting and diarrhea.									U	10/03/1998	10/08/1998	5		UNK	UNK					U1998006130	1						1	Diarrhoea; Vomiting	FLU3~CONNAUGHT LABORATORIES~0975790~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152772	06/07/2000	NJ	48.0	48		F	11/12/1998	On 10/7/98, the pt developed hives on torso and upper leg. Pt stated that hives are fading away.									Y	10/06/1998	10/07/1998	1		OTH	PUB			Recent UTI		U1998006140	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~0977210~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152773	06/07/2000	NJ	61.0	61		F	10/13/1998	It was reported that a 61 year old female received Fluzone 98-99 on October 6, 1998. Reportedly at 6:00 PM that same day the pt's eyes were red, felt she had sand in her eyes, (also experienced) ears itching and vaginal itching. The pt reportedly took Benadryl which stopped the itching. On 10/7/98 her eyes remained red. Reportedly the pt recovered from this experience.									Y	10/06/1998	10/06/1998	0		PUB	PUB	Zocor	NONE	NONE		U1998006230	1						1	Ear disorder; Eye disorder; Ocular hyperaemia; Pruritus	FLU3~CONNAUGHT LABORATORIES~0978660~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152774	06/07/2000	OH	45.0	45		F	10/14/1998	It was reported that a 45 year old female received Fluzone 98-99 on 10/9/98. Reportedly the pt experienced hives.									U	10/09/1998	10/09/1998	0		UNK	UNK					U1998006250	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~0977210~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152775	06/07/2000	OH	70.0	70		F	10/14/1998	It was reported that a 70 year old female received Fluzone 98-99 on 10/2/98. Reportedly pt jaundiced within 24 hours post vax. Pt is not undergoing tests.									U	10/02/1998				UNK	UNK					U1998006260	1						1	Jaundice	FLU3~CONNAUGHT LABORATORIES~0965770~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152776	06/07/2000	GA	53.0	53		F	10/15/1998	It was reported that a 53 year old female received Fluzone 98-99 on 10/7/98. Reportedly sometime post vax, the pt experienced a large local reaction at the injection site.									U	10/07/1998				UNK	UNK					U1998006280	1						1	Injection site reaction	FLU3~CONNAUGHT LABORATORIES~0969610~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152777	06/07/2000	SC	34.0	30		U	11/03/1998	It was reported that a 34 year old female received Fluzone 98-99 sometime between 10/9/98 to 10/12/98. Reportedly sometime after the vax, the pt experienced systemic reactions of headache and nausea. From additional information received November 2, 1998 it was reported that the pt's symptoms lasted 48 hours. Reportedly the pt recovered from this experience.									Y	10/09/1998				UNK	UNK					U1998006290	1						1	Headache; Nausea	FLU3~CONNAUGHT LABORATORIES~0980580~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152778	06/07/2000	SC	51.0	51		F	11/03/1998	Post vax, the pt experienced systemic reactions of headache, nausea and diarrhea. The pt also experienced a runny nose that lasted one week.									Y	10/09/1998				UNK	UNK					U1998006300	1						1	Diarrhoea; Headache; Nausea; Rhinorrhoea; Abdominal pain upper; Diarrhoea; Headache; Malaise; Myalgia; Nausea; Pyrexia; Rhinorrhoea; Vomiting	FLU3~CONNAUGHT LABORATORIES~0980580~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0980580~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0152779	06/07/2000	SC	65.0	65		F	11/03/1998	It was reported that a 65 year old female received Fluzone 98-99 sometime between 10/9/98 to 10/12/98. Reportedly sometime after the vaccination, the pt experienced systemic reactions of headache, nausea, vomiting and myalgia. From additional information received 11/3/98 it was reported that the pt's experience of nausea, vomiting and myalgia lasted 8 hours. Reportedly the pt experienced a severe headache lasting 72 hours, slightly eased by Tylenol two, four times a day. After the headache eased up the pt experienced pain in the cervical spine and across shoulders lasting 3 more days. Reportedly the pt recovered from this experience.									Y	10/09/1998				UNK	UNK					U1998006310	1						1	Arthralgia; Back pain; Headache; Myalgia; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~0980580~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152780	06/07/2000	SC	49.0	49		M	11/03/1998	It was reported that a 49 year old male received Fluzone 98-99. Reportedly sometime after the vax, the pt experienced systemic reactions of headache, general malaise, fever, and myalgia. From additional information received on 11/3/98 it was reported that the pt also experienced hoarseness and cough lasting 48 hours. Reportedly the pt recovered from this experience.									Y	10/09/1998				UNK	UNK					U1998006320	1						1	Cough; Dysphonia; Headache; Malaise; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0980580~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152781	06/07/2000	SC	37.0	37		F	11/03/1998	It was reported that a 37 year old female received Fluzone 98-99 sometime between 10/9/98 to 10/12/98. Reportedly sometime after the vax, the pt experienced systemic reactions of headache, general malaise, fever, nausea, and vomiting. From additional information received 11/3/98, it was reported that the pt also experienced diarrhea which lasted for 24 hours, and hoarseness and cough lasting for 5 days. The pt reportedly took Motrin for headache and soreness in throat.									U	10/09/1998				UNK	UNK					U1998006330	1						1	Cough; Diarrhoea; Dysphonia; Headache; Malaise; Nausea; Pharyngolaryngeal pain; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~0980580~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0152782	06/07/2000	SC	45.0	45		F	11/03/1998	It was reported that a 45 year old female received Fluzone 98-99 sometime from 11/9/98 through 10/12/98. Reportedly sometime after the vaccination the pt experienced a headache for 24 hours. Reportedly the pt recovered form this experience.									Y	10/09/1998				UNK	UNK					U1996006340	1						1	Headache	FLU3~CONNAUGHT LABORATORIES~0980580~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0134193	06/08/2000	SC	34.0	34		M	02/03/2000	2 days post vacc pt upper inside l/arm became red, swollen, warm to touch, tender to touch and developed a knot, measureing 2 1/2 x 2. Went to ER for evaluation.  The MD's diagnosis is cellulitis possibly due to Flu shot.				Y					U	01/28/2000	01/30/2000	2		PUB	PUB	Depakote, Zestril, Tenornun, Procardia	NONE	hypertension	~ ()~~~In patient	SC00007	1						1	Cellulitis; Oedema; Pain; Skin nodule; Vasodilatation; Cellulitis; Oedema; Pain; Skin nodule; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0205AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0205AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0134193	06/08/2000	SC	34.0	34		M	02/03/2000	2 days post vacc pt upper inside l/arm became red, swollen, warm to touch, tender to touch and developed a knot, measureing 2 1/2 x 2. Went to ER for evaluation.  The MD's diagnosis is cellulitis possibly due to Flu shot.				Y					U	01/28/2000	01/30/2000	2		PUB	PUB	Depakote, Zestril, Tenornun, Procardia	NONE	hypertension	~ ()~~~In patient	SC00007	1						2	Cellulitis; Oedema; Pain; Skin nodule; Vasodilatation; Cellulitis; Oedema; Pain; Skin nodule; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~U0205AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0205AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0152835	06/08/2000	AZ	11.0	11		F		No data provided.  60 day follow-up received on 10/13/00 provided a name change and stated that the pt did not recover.  Medical records stated child was admitted to hospital and had laproscopic surgery for adhesions and an appendectomy.  Also diagnosed with psychosomatic back pain.  Doc # 178811 do not provide the type of vaccine, but the name of the manufacturer and a date: Wyeth 06/2000.			Y	Y	Y	4			Y	10/20/1999	10/20/1999	0		PVT	PVT		NONE		Measles~Measles + Mumps + Rubella (MMR II)~2~1.00~In Patient		1						1	Back pain; Unevaluable event	FLU3~PFIZER\WYETH~4998239~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0153046	06/08/2000	WA	3.0	3		F	02/17/2000	A child received vaccines on 2/10/00. That evening developed a fever of 103 and pain in the left leg. Went to ER and was diagnose with UTI and given Cephalexin. On 2/11/00 the child was unable to walk on left leg. Mom denies redness or swelling to the left thigh injection site. Mom instructed to treated with Tylenol and cold packs. Follow up 2/12/00, the pt complained of left leg pain, left  thigh was swollen, erythema in the skin and painful by palpation at injection site. Assessment is skin reaction to immunization.				Y					Y	02/10/2000	02/10/2000	0		PVT	OTH		NONE	NONE		WA001646	1						1	Difficulty in walking; Injection site erythema; Injection site oedema; Injection site pain; Urinary tract infection	FLU3~CONNAUGHT LABORATORIES~U0130AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1611H~1~IM~LL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0153066	06/08/2000	AK	22.0	21		M	04/13/2000	Onset of chronic dermatitis associated within initiation of Anthrax vaccine. Persistent flares in dermatitis, 4 1/2 months since last dose.				Y					N	10/27/1998	11/10/1998	14	Patch testing:2+ Q-15 and formaldehyde	MIL	MIL		NONE	NONE			1						1	Dermatitis	ANTH~MICHIGAN DEPT PUB HLTH~~UNK~SC~~ANTHRAX (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4988247~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0153078	06/08/2000	NV	58.0	58		F	03/10/2000	Swelling (10cm X 10cm) and erythema at IZ site that persists. Slightly decreased with prednisone and Augmentin.									N	12/17/1999			CT/Ultrasound	MIL	MIL	NONE	NONE	NONE			1						1	Injection site erythema; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~U0135AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0153131	06/08/2000	NY	71.0	71		F	05/02/2000	The pt did not have an adverse reaction to either vaccine on 11/17/1999. The pt most likely had a URI - viral infection independent of immunization.									U	11/17/1999				PVT	PVT	Glucatrol, Accupril	NONE	high blood pressure, diabetes mellitus			1						1	Upper respiratory tract infection; Viral infection	FLU3~CONNAUGHT LABORATORIES~U0205AA6100~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0042110100~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0153179	06/08/2000	CA	44.0	44		M	04/07/2000	Partial Paralysis in neck and back region on left side with recurrent muscle fatigue. Major symptom subsided on the 24th, but continued muscular weakness and pain took several months to dissipate. Fatigue and lack of mobility persist to date. Dx: pinched nerve. Receiving physical therapy.				Y					N	12/22/1999	12/26/1999	4		PVT	PVT	NONE	NONE	NONE			1						1	Fatigue; Hypokinesia; Muscular weakness; Myalgia; Paralysis	FLU3~PARKDALE PHARMACEUTICALS~022898P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0153216	06/08/2000	WY	46.0	44		F	05/04/2000	Generalized weakness including angioedema since about 7-10 days, post vax, persistent to the present. Refractory to multiple medicines. Evenually fairly well controlled, but not resolved. Treated as idiopathic urticaria, but pt believes it is secondary to Fluzone.				Y					N	10/26/1998	11/05/1998	10	Immune studies-neg	PVT	PVT	Augmentin	Plantar wart	Allergies to drugs, chronic bronchitis secondary to smoking, prior spinal surgery.			1						1	Angioneurotic oedema; Asthenia; Urticaria	FLU3~CONNAUGHT LABORATORIES~0965760~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0153352	06/09/2000	TX	31.0	30		F	12/07/1999					Y					Y	11/08/1999	11/08/1999	0		OTH	PVT						1						1	Headache; Migraine	FLU3~PARKDALE PHARMACEUTICALS~004991~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0153362	06/09/2000	CA	19.0	18		M	03/03/2000	The pt reportedly developed a rash and fever of 100.4 approximately 40 hours following vax. The rash was red and raised on inner aspects of wrists, forearms and both feet. Macular rash on upper and lower legs, chest and abdomen. The pt was treated with diphenhydramine and acetaminophen. Rash disappeared on 10/16/1999.									Y	10/13/1999	10/15/1999	2	NONE	OTH	PUB	Pemoline, Talnaftate, benzoyl peroxide		NONE			1						1	Pyrexia; Rash; Rash erythematous; Rash macular	FLU3~PFIZER\WYETH~4998255~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0153405	06/09/2000	MD	50.0	50		F	04/26/2000	Employee received the influenza vaccine on 10/18/99, in the afternoon at 15:30 and experienced a sore arm and had a suspician of a hot ache at the site. She has experienced some weakness when raising her arm in a perpendicular position. The achiness is worse at night but the arm doesn't bother her all the time. She can lift children with no discomfort. The site remains sore to touch.									U	10/18/1999	10/18/1999	0		PVT	PVT		NONE				1						1	Feeling hot; Injection site pain; Pain; Asthenia; Injection site pain; Injection site warmth; Pain	FLU3~PFIZER\WYETH~4999265~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4998265~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0153443	06/09/2000	PA	64.0	64		F		Extreme pain at injection site. Unable to use arm. Flu symptoms from November to March 2000. Joint and muscle pain with difficulty in stooping, bending, walking, etc. Pt did not produce results. Treated with pain medicines (Ultram 50 and Vioxx). Continues to see 2 different doctors.				Y					N	11/05/1999	11/08/1999	3	X-rays, Bone Scan, CT Scan, Blood work, Liver functions	PVT	UNK						1						1	Arthralgia; Hypokinesia; Influenza like illness; Injection site pain; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~4653124~UNK~IM~~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0153491	06/09/2000	TX				M	05/16/2000	This physician was immunized at work. His doctor, who is treating him for polymyalgia Rheumatoid. Please refer questions either to the vaccinee or his treating physician.									U	11/01/1999			UNK	OTH	PUB	UNK	UNK	UNK			1						1	Unevaluable event	FLU3~CONNAUGHT LABORATORIES~U0163AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0153568	06/09/2000	AR	41.0	41		F	11/23/1999	At 10:30 achiness, 1-2 hours later chills, took Tylenol. 15:00 temperature of 102 with achiness, stiffness all over. Started stiffness upper body and worked down, cough, when breathed pain in chest. These symptoms continued 3 days worsened in late afternoon and late evening. Day 4 and 5 night sweats, day 6 continue stiff neck.									Y	11/16/1999	11/18/1999	2		PUB	UNK	NONE	NONE	NONE		AR0001	1						1	Chest pain; Chills; Cough; Musculoskeletal stiffness; Night sweats; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0153594	06/09/2000	AR	22.0	22		F	11/10/1999	Post vax, red macules appeared on abdomen, chest and neck, 1/4 cm circumference, 8-9 hours later, no itching, denies SOB, saw MD 11/8/1999 who stated rash probably from immunization. Had already began Benadryl.				Y					Y	11/05/1999	11/05/1999	0	NONE	PUB	PUB	NONE	NONE	NONE		AR0005	1						1	Rash macular	FLU3~CONNAUGHT LABORATORIES~U0129AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0153606	06/09/2000	AR	1.0	1	.1	M	04/14/2000	Mother stated pt had red raised approximately 2 1/2 cm lesion top of head x 1 wk, was seen by MD. He stated that it looked like a fungus rash kept expanding to a confluent rash on right side of head with a linear line across right cheek bone. Dx as shingles.				Y					N	12/28/1999	04/07/2000	101		PUB	OTH	(Varivax, Merck, 0119A, SC, RA)	NONE	NONE		AR0014	1						1	Cellulitis; Herpes zoster; Infection; Rash erythematous	DTAP~CONNAUGHT LABORATORIES~~3~IM~RA~DTAP (TRIPEDIA)~1|FLU3~CONNAUGHT LABORATORIES~U0165AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~CONNAUGHT LABORATORIES~P0877AP~4~IM~RA~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0351J~1~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1|OPV~PFIZER\WYETH~0801M~3~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~1	USA	Emergency room visit	Influenza
0153630	06/09/2000	OH	73.0	73		F	05/01/2000	Pt complaint immediate pain following injection. Pain has become chronic with lump at site.									U	10/22/1999	10/22/1999	0	Had x-ray right arm.	PUB	PUB	BP medication	NONE	hypertensive, hip problem, no known allergies		OH00024	1						1	Injection site mass; Injection site pain	FLU3~CONNAUGHT LABORATORIES~U0144AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1584H~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0153689	06/09/2000	TN	16.0	16		F	01/10/2000	A few hours post vax, pt broke out with a whelpy rash on face and trunk. No difficulty breathing, wheezing, weakness or dizziness. Mother gave 50mg Benadryl. Symptoms gone by the next morning.									Y	01/07/2000	01/07/2000	0		PUB	PUB					TN00001	1						1	Urticaria	FLU3~MEDEVA PHARMA, LTD.~MEDE30899LA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0153691	06/09/2000	TN	39.0	39		F	02/01/2000	Pt states pain in left shoulder and back began next day after injection and lasted 1 1/2 - 2 weeks. Now she states approximately 1 week ago she noticed a dark spot (4 3/4 down from shoulder, 2mm x 2mm) with a lump (7mm x 4mm) underneath at site of injection. Pt appears to be extremely tender at this site. She was refered to health department on 02/02/2000. She also states parestheisa is noted at and around site.									U	10/27/1999	10/28/1999	1		PUB	PUB	NONE	NONE	ASA, caffeine, Bactrim - allergy to medication		TN00003	1						1	Injection site mass; Injection site pain; Injection site reaction; Paraesthesia; Skin discolouration	FLU3~CONNAUGHT LABORATORIES~U0150AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0153708	06/09/2000	AZ	41.0	40		M	05/04/2000	Post 2nd vax, the client developed, rash, clammy skin, respiratory, shallow, hypotensive (60/30). He remained verbal; no pain, and responsive. With- in 2-3 min, BP 100/60, pulse 80, Resp. 16-20.				Y					Y	01/08/2000	01/08/2000	0		MIL	MIL						1						1	Cold sweat; Hypotension; Hypoventilation; Rash	FLU3~CONNAUGHT LABORATORIES~U0135AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0998H~UNK~IM~LA~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0153718	06/09/2000	OH	73.0	73		M	05/26/2000	Claims excessive fatigue, past 6 weeks.									U	10/15/1999	04/01/2000	169	CBC, sed rate, none abnormal	PVT	PVT		NONE	NONE			1						1	Fatigue	FLU3~CONNAUGHT LABORATORIES~U0148AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0153790	06/09/2000	SC	0.2	0	.2	F	06/02/2000	Pt very fussy, cried for four hours in high pitched cry. Denies fever > 99.5. Called MD at 4 month old shot, MD recommended pt only receive from 4 month shots today and in the future.									Y	03/15/2000	03/15/2000	0	NONE	PUB	PUB	UNk	NONE				1						1	Irritability; Screaming	DTAP~SMITHKLINE BEECHAM~912A~1~IM~LL~DTAP (INFANRIX)~1|FLU3~PARKE-DAVIS~P0932AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUOGEN)~1|HEP~SMITHKLINE BEECHAM~320909~1~IM~RL~HEP B (ENGERIX-B)~1|IPV~CONNAUGHT LTD.~P0553~1~SC~LL~POLIO VIRUS, INACT. (POLIOVAX)~1	USA		Influenza
0153852	06/09/2000	MA	26.0	26		M	06/05/2000	GI Symptoms 24 hours, dizziness, seizure on 4/20/2000.				Y					Y	04/16/2000	04/17/2000	1		MIL	MIL	NONE	NONE	NONE			1						1	Convulsion; Dizziness; Gastrointestinal disorder	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~VA199AA~1~IM~~MENINGOCOCCAL (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0153862	06/09/2000	MD	68.0	68		F	06/01/2000	With in six hours after vax, marked pain occured in arm injected and pt wrist became painful and swollen on awakening, followed by left wrist hours later. Both wrists were increasingly swollen, red, tender, malaise increase persisted for > 2 months, pt had known RA for > 30 years that had been under complete remission for > 15 years prior to present event.									Y	11/12/1999	11/12/1999	0	NONE	PUB	PUB			rheumatoid Arthritis in remission for > 15 years.			1						1	Condition aggravated; Erythema; Joint swelling; Malaise; Pain; Rheumatoid arthritis	FLU3~PARKDALE PHARMACEUTICALS~00399P~7+~SC~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~UNKNOWN MANUFACTURER~1692H~2~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0153888	06/09/2000	NY	17.0			M	04/04/2000	Temp of 101 on 1/27, may be related to flu vax, also grape fruit sized welts at site. 1/29 Benadryl given, Benadryl cream and ice packs to welt.									Y	01/26/2000	01/26/2000	0		UNK	UNK		Flu				1						1	Injection site urticaria; Pyrexia	FLU3~PFIZER\WYETH~4998261~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1482J~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0129372	06/13/2000	TN	27.0	27		F	01/13/2000	Same day post vax, the pt developed an injection site reaction characterized by redness and swelling which extended to the elbow. This is one of three pts from this facility who had an adverse event following receipt of the vax.									U	10/07/1999	10/07/1999	0	UNK	UNK	OTH	Proventil inhaler	NONE	UNK		HQ2568314OCT1999	1						3	Cellulitis; Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation; Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~MERCK & CO. INC.~1592H~1~IM~RA~PNEUMO (PNEUMOVAX)~2|FLU3~PFIZER\WYETH~4998224~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~3|PPV~MERCK & CO. INC.~1692H~UNK~IM~RA~PNEUMO (PNEUMOVAX)~3	USA		Influenza
0129382	06/13/2000	TN	28.0	28		M	01/05/2000	On 10/13/99, the pt developed a 4 cm x 6 cm area of swelling and redness at the injection site. He was seen by the physician who prescribed Tylenol and Benadryl.				Y					U	10/12/1999	10/13/1999	1	UNK	PVT	OTH	Lipitor	NONE	UNK		HQ2554114OCT1999	1						2	Injection site erythema; Injection site oedema	FLU3~PFIZER\WYETH~4998224~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~MERCK & CO. INC.~1692H~UNK~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0129842	06/13/2000	PA				F	02/15/2000	A female reported that post vax with in hours she developed a low grade fever. She self medicated with Motrin. She then developed headache, dizziness, and nausea. The pt attributed this event to a thimersol allergy. The patient's headache and dizziness persisted. The patients thoughts are jumbled and she feels confused at times. MD prescibed steroids. MD does not believe the pt sx are related to Flu vax.				Y					U	10/16/1999	10/16/1999	0		PVT	OTH	NONE	NONE	possible allergy to Sulfa, drug hypersensitivity		HQ4004229OCT1999	1						2	Confusional state; Dizziness; Headache; Nausea; Pyrexia	FLU3~PFIZER\WYETH~4998212~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0129887	06/13/2000	GA	46.0	46		F	10/12/1999	p/vax burning, hives appeared upper arms, chest, face, lips swollen;to ER given pred & DPH;				Y					Y	10/11/1999	10/11/1999	0	NONE	PVT	PVT		NONE	dust allergy,perfume allergy;sulfa allergy;	NONE~ ()~~~In patient		1						1	Face oedema; Pain; Urticaria; Face oedema; Pain; Urticaria; Face oedema; Flushing; Injection site oedema; Pruritus; Swelling	FLU3~PFIZER\WYETH~4998218~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4998218~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|FLU3~PFIZER\WYETH~4998218~3~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~3	USA	Emergency room visit	Influenza
0129887	06/13/2000	GA	46.0	46		F	10/12/1999	p/vax burning, hives appeared upper arms, chest, face, lips swollen;to ER given pred & DPH;				Y					Y	10/11/1999	10/11/1999	0	NONE	PVT	PVT		NONE	dust allergy,perfume allergy;sulfa allergy;	NONE~ ()~~~In patient		1						2	Face oedema; Pain; Urticaria; Face oedema; Pain; Urticaria; Face oedema; Flushing; Injection site oedema; Pruritus; Swelling	FLU3~PFIZER\WYETH~4998218~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4998218~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|FLU3~PFIZER\WYETH~4998218~3~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~3	USA	Emergency room visit	Influenza
0129888	06/13/2000	GA	37.0			F		p/vax pt exp flushing & swelling on arms, chest & face;prescribed medrol dose pak & DPH;				Y					Y	10/11/1999	10/11/1999	0	NONE	PVT	PVT		NONE	NONE	NONE~ ()~~~In patient		1						1	Face oedema; Oedema; Vasodilatation; Face oedema; Oedema; Vasodilatation	FLU3~PFIZER\WYETH~4998218~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4998218~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0129888	06/13/2000	GA	37.0			F		p/vax pt exp flushing & swelling on arms, chest & face;prescribed medrol dose pak & DPH;				Y					Y	10/11/1999	10/11/1999	0	NONE	PVT	PVT		NONE	NONE	NONE~ ()~~~In patient		1						2	Face oedema; Oedema; Vasodilatation; Face oedema; Oedema; Vasodilatation	FLU3~PFIZER\WYETH~4998218~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4998218~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0130255	06/13/2000	PA	3.0	3		F	10/28/1999	swollen, red, tender lt arm;3x3T induration area;				Y					Y	10/26/1999	10/27/1999	1	NONE	PUB	PUB	Albuterol, Intal, Atrovent, Claritin, Zantac, Singular	NONE	allergies, eczema, reflux;	pt exp rxn @ 2mo w/DTAP/HIB dose 1;~DTaP + Hib (no brand name)~1~0.20~Patient		1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4998247~4~SC~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4998247~4~SC~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0130255	06/13/2000	PA	3.0	3		F	10/28/1999	swollen, red, tender lt arm;3x3T induration area;				Y					Y	10/26/1999	10/27/1999	1	NONE	PUB	PUB	Albuterol, Intal, Atrovent, Claritin, Zantac, Singular	NONE	allergies, eczema, reflux;	pt exp rxn @ 2mo w/DTAP/HIB dose 1;~DTaP + Hib (no brand name)~1~0.20~Patient		1						2	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4998247~4~SC~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4998247~4~SC~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0131720	06/13/2000	PA	35.0	34		F	10/31/1999	Pt states she has had a rash that began the morning after getting her flu shot.				Y					Y	10/29/1999	10/30/1999	1	NONE	PVT	OTH	prilosec, celexa	NONE	depression, acid reflux, allergy, steroid treatment for feet edema	~ ()~~~In patient		1						1	Depression; Gastrointestinal disorder; Rash; Depression; Gastrointestinal disorder; Rash	FLU3~PFIZER\WYETH~4998267~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4998267~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0131720	06/13/2000	PA	35.0	34		F	10/31/1999	Pt states she has had a rash that began the morning after getting her flu shot.				Y					Y	10/29/1999	10/30/1999	1	NONE	PVT	OTH	prilosec, celexa	NONE	depression, acid reflux, allergy, steroid treatment for feet edema	~ ()~~~In patient		1						2	Depression; Gastrointestinal disorder; Rash; Depression; Gastrointestinal disorder; Rash	FLU3~PFIZER\WYETH~4998267~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4998267~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0132722	06/13/2000	CO	83.0	83		F	11/23/1999	Pain in L/arm @ time of injection on 9/29/99.  Pain has persisted and arm continues to weaken.  Cannot lift anything with arm.  Saw a doctor and was advised to see a bone doctor.				Y						09/29/1999	09/29/1999	0		PUB	PUB		Hx of CVA, R/Side weakness			CO99045	1						1	Asthenia; Cerebrovascular accident; Hypokinesia; Pain; Asthenia; Cerebrovascular accident; Hypokinesia; Pain	FLU3~PFIZER\WYETH~4998227~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4998227~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0132722	06/13/2000	CO	83.0	83		F	11/23/1999	Pain in L/arm @ time of injection on 9/29/99.  Pain has persisted and arm continues to weaken.  Cannot lift anything with arm.  Saw a doctor and was advised to see a bone doctor.				Y						09/29/1999	09/29/1999	0		PUB	PUB		Hx of CVA, R/Side weakness			CO99045	1						2	Asthenia; Cerebrovascular accident; Hypokinesia; Pain; Asthenia; Cerebrovascular accident; Hypokinesia; Pain	FLU3~PFIZER\WYETH~4998227~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4998227~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0134439	06/13/2000	IN	53.0	53		F	01/18/2000	Next day post vax, the pt felt sick to her stomach and developed an injection site reaction characterized by a 3.5 inch circle of redness and warmth. The pt recovered.									Y	11/10/1999	11/11/1999	1	UNK	OTH	OTH	UNK	NONE	UNK		HQ7688307DEC1999	1						2	Dyspepsia; Vasodilatation; Dyspepsia; Injection site hypersensitivity; Vasodilatation	FLU3~PFIZER\WYETH~4998260~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4998260~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0153951	06/13/2000	PA	36.0	36		F	04/18/2000	Pt developed, redness at injection site of flu vax. Left upper arm redness cool compress applied to site. Shortly there after pt complained of swelling of the tongue, with progressive symptoms. Benadryl given in right arm.									Y	04/17/2000	04/17/2000	0	NONE	PUB	PUB	UNK	NONE	PCN, EES, Bactrim		PA2023	1						1	Injection site erythema; Tongue oedema	FLU3~MEDEVA PHARMA, LTD.~E24259GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~SMITHKLINE BEECHAM~639B6~2~IM~RA~HEP A (HAVRIX)~1	USA		Influenza
0153969	06/13/2000	NJ				F	05/02/2000	Within 5 minutes post vax, the pt stated that she felt funny, her tongue felt thick and she experienced numbness in her toes. The pt was administered epinephrine and Benadryl parenterally and taken by ambulance to the hospital.			Y	Y					Y	10/19/1999	10/19/1999	0	UNK	OTH	PVT	NONE	NONE	UNK		HQ3324222OCT1999	1						1	Hypoaesthesia; Tongue disorder	FLU3~PFIZER\WYETH~4998267~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening	Influenza
0153987	06/13/2000	MN	26.0	25		U	01/13/2000	A nurse reported that a 26 year old pt received an injection, the pt developed an injection site reaction characterized by a fluid-filled blister and redness that extended down the pt's arm. As of 10/25/99, the blister had gone down and the redness was better.									Y	10/18/1999	10/18/1999	0	UNK	PUB	OTH	NONE	NONE	UNK		HQ3468225OCT1999	1						1	Blister; Injection site erythema	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0153988	06/13/2000	OH				U	01/26/2000	A pharmacist reported that several elderly residents of a nursing home received and injection in October, 1999 and subsequently developed flu-like symptoms. The reporter was unable to specify the number of pt who experienced this event. Additional reports will be generated when identify information is provided.									U	10/01/1999				UNK	UNK	UNK	UNK	UNK			1						1	Influenza like illness	FLU3~PFIZER\WYETH~4998223~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0153989	06/13/2000	CA	44.0	44		M	11/02/1999	With in 15 minutes, he developed ringing in the ears. As of Oct 26, 1999, the tinnitis has been almost constant and has not improved.									U	09/29/1999	09/29/1999	0		PVT	OTH	NONE	NONE	UNK		HQ3688327OCT1999	1						1	Tinnitus	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0153990	06/13/2000	IN				F	01/20/2000	A physician reported that a nurse administered vax to 10 pts on Oct 22, 1999. On Oct 23, 1999, the nurse developed myalgia, cramping  and nausea. She recovered, the physician stated. Do not believe this pt sx were related to the flu vax.									Y	10/22/1999	10/23/1999	1		OTH	OTH	UNK	UNK	UNK		HQ3690327OCT1999	1						1	Muscle spasms; Myalgia; Nausea	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0153991	06/13/2000	NV				U	11/02/1999	A nurse reported that ten days post vax the pt developed blisters in and on the nose. The pt reported having rec. many doses of influenza virus vax and never having experienced this event.									U	10/12/1999	10/21/1999	9		PVT	UNK	UNK	UNK	UNK		3692127	1						1	Blister	FLU3~PFIZER\WYETH~4998270~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0153992	06/13/2000	TX				U	11/02/1999	A nurse reported that 60 to 75 % of the residents and staff of long term care facility received vax on Oct 10, 1999. With in 1 to 2 days they developed nausea, vomiting and diarrhea which lasted approximately 72 hours or longer. The reporter also stated that some patients rec pnuemococcal vax, the reporter was unable to specify the number of residents and staff who experienced this event.									U	10/10/1999	10/12/1999	2	UNK	OTH	OTH	UNK	UNK	UNK		HQ3708227OCT1999	1						1	Diarrhoea; Nausea; Vomiting	FLU3~PFIZER\WYETH~4998287~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0153993	06/13/2000	UT	35.0	35		F	01/27/2000	A nurse reported with in two days pt developed an injection site reaction characterized by pain and swelling. She also experienced weakness and heaviness of the arm into which the vax was injected. The pt reported that she had trouble lifting or using the arm. When she lifted the arm, she experienced shooting pains which radiated to her shoulder and the back of her neck. This is 1 of 2 pts from facility who experienced AE.									U	10/14/1999	10/16/1999	2	UNK	PVT	PVT	NONE	NONE	UNK		HQ3760127OCT1999	1						1	Injection site oedema; Injection site pain; Pain; Sensation of heaviness	FLU3~PFIZER\WYETH~4998230~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0153994	06/13/2000	AR	32.0	52		F	01/26/2000	A nurse reported that a 52 yr old employee received vax, with in 24 to 36 hours, she developed generalized weakness, achiness, headache and fever. She also developed soreness and achiness in the arm into which the vaccine was injected.									Y	10/14/1999	10/14/1999	0	UNK	PVT	PVT	UNK	NONE	UNK		HQ3784127OCT1999	1						1	Asthenia; Headache; Pain; Pyrexia	FLU3~PFIZER\WYETH~4998287~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0153995	06/13/2000	WI				U	01/26/2000	A pharmacist reported a few patients and  staff members received vax, post vax symptoms consisting of aches and pains, diarrhea, and malaise. With in 3-5 days, all patients recovered. The reporter was unable to specify the number of patients who experienced these events, or to identify any of the pt.									Y	10/06/1999	10/20/1999	14	UNK	OTH	OTH	UNK	UNK	UNK		HQ3914328OCT1999	1						1	Diarrhoea; Malaise; Pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0153997	06/13/2000	IL	39.0			F	01/05/2000	A nurse reported that 39 year old pt received vax and the next day she developed nausea, fever and general aches.									Y	10/20/1999	10/21/1999	1		OTH	PVT	Oral Contraceptive	NONE	Pt has history of penicillin and sulfa allergies. Hypersensitivity NOS		HQ4314402NOV1999	1						1	Nausea; Pain; Pyrexia	FLU3~PFIZER\WYETH~4998265~4~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0153998	06/13/2000	PA				F	01/13/2000	Pt developed site reaction characterized by redness, swelling, pain and induration, the pt also experienced arm heaviness.									U	10/28/1999	10/28/1999	0	UNK	PUB	OTH	UNK	UNK	hypersensitivity NOS		HQ4424103NOV1999	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Injection site pain; Sensation of heaviness	FLU3~PFIZER\WYETH~4998279~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0153999	06/13/2000	PA	54.0	54		F	01/24/2000	With in 6 hours pt developed moderately debilitating lymphadenopathy described as severe pain at the axillary aspect of the arm and engorged lymph nodes. Pt also developed a mild site reaction, pt was treated with Fiorinal. She lost 4 nights of sleep.									Y	10/27/1999	10/27/1999	0		PVT	OTH	Estrace, Vitamins	NONE	codeine allergy, drug hypersensitivity.		HQ4428203NOV1999	1						1	Injection site reaction; Lymphadenopathy	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154000	06/13/2000	IL				F	01/21/2000	Three days post vax, the pt developed neck stiffness, a sore throat, and pain radiating across her forehead. She recovered in 2 days without treatment.									Y	10/05/1999	10/08/1999	3		PUB	OTH	NONE	NONE	UNK		HQ4568204NOV1999	1						1	Headache; Musculoskeletal stiffness; Pharyngolaryngeal pain	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154001	06/13/2000	TX				F	01/18/2000	Within hours post vax, the pt stated that she did not feel well. She then developed flu-like symptoms. This is one of two reports from this facility of adverse experiences following receipt of vax.									U	10/06/1999	10/06/1999	0	UNK	PVT	OTH	UNK	UNK	UNK		HQ4584204NOV1999	1						1	Influenza like illness	FLU3~PFIZER\WYETH~4998257~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154002	06/13/2000	UT	57.0	57		F	12/13/1999	On 10/15/99, the pt experienced pain and weakness in her right arm starting at her neck and extending to her fingertips.				Y					U	10/08/1999	10/15/1999	7	MRI-ruptured disc in her neck	PUB	OTH	UNK	NONE	UNK		HQ4622304NOV1999	1						1	Muscular weakness; Pain	FLU3~PFIZER\WYETH~~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0154003	06/13/2000	IL	73.0	72		M	01/20/2000	On 10/31/99, the pt developed double vision. He has been seen by an opthalmologist who can find nothing wrong.				Y					U	10/11/1999	10/31/1999	20	MRI, angiogram, CT, doppler-nml	OTH	OTH	UNK	NONE	UNK		HQ4836108NOV1999	1						1	Diplopia	FLU3~PFIZER\WYETH~4998272~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0154004	06/13/2000	IA	42.0	42		F	01/05/2000	Within 6 hours post vax, the pt developed deep hip pain, shortness of breath, nausea, and copious sinus drainage. The pt was treated for an upper respiratory infection.									Y	10/26/1999	10/26/1999	0	UNK	OTH	OTH	Zyban	NONE	UNK		HQ4970108NOV1999	1						1	Arthralgia; Dyspnoea; Nausea; Sinus congestion; Upper respiratory tract infection	FLU3~PFIZER\WYETH~4998218~4~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154005	06/13/2000	WI				F	01/13/2000	Within 5 minutes post vax, the pt developed severe pain in the supraventricular area which radiated to her ear down the shoulder and into the arm. She consulted her nurse practitioner who told her to take Advil. As of 11/8/99, she continued to have pain in the supraventricular area. She had also developed numbness in part of her hand and difficulty with movement in the shoulder area.				Y					U	10/02/1999	10/02/1999	0	UNK	OTH	OTH	UNK	NONE	UNK		HQ5022209NOV1999	1						1	Hypoaesthesia; Hypokinesia; Pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0154006	06/13/2000	OH	58.0	58		F	12/07/1999	Within 6 days post vax, the pt developed flu-like symptoms, described as headache, fever of 102, arthralgia, myalgia, and nausea.									U	11/01/1999	11/07/1999	6	UNK	PVT	OTH	UNK	UNK	UNK		HQ5152110NOV1999	1						1	Arthralgia; Headache; Myalgia; Nausea; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154007	06/13/2000	CA				F	01/27/2000	Within 30 minutes post vax, the pt developed an injection site reaction characterized by itching and a 1 cm wheal, and paresthesia of the left arm. She was seen by the nurse and recovered within 4 hours without treatment. This is one of three employees from this facility who had an adverse experience following receipt of vax.				Y					Y	10/29/1999	10/29/1999	0	UNK	PVT	PVT	UNK	NONE	UNK		HQ5242110NOV1999	1						1	Injection site urticaria; Paraesthesia; Pruritus	FLU3~PFIZER\WYETH~4998230~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0154008	06/13/2000	TX				U	11/15/1999	A pharmacist reported that 80% of the residents in 2 long term care facilities received vax and became violently sick.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ5248210NOV1999	1						1	Feeling abnormal	FLU3~PFIZER\WYETH~4998220~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154009	06/13/2000	MD				M	01/26/2000	Within 6 hours post vax, the pt developed excessive gas which lasted a few days.									Y	11/05/1999	11/05/1999	0	UNK	OTH	OTH	UNK	NONE	UNK		HQ5316411NOV1999	1						1	Flatulence	FLU3~PFIZER\WYETH~4998245~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154010	06/13/2000	MD	41.0	41		F	11/30/1999	Same day post vax, the pt developed numbness in the fingers of her left arm and an injection site reaction characterized by shooting pains which extended to her left elbow, burning and itching. The numbness and pain resolved, however, the itching at the injection site persisted. This is one of three pts from this facility who experienced an adverse event following receipt of vax.									Y	11/10/1999	11/10/1999	0	UNK	OTH	OTH	UNK	UNK	UNK		HQ5752116NOV1999	1						1	Hypoaesthesia; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~4998245~5~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154011	06/13/2000	NY	81.0	81		F	12/07/1999	Subsequently post vax, the pt developed shortness of breath, internal tremor, metallic taste, dry mouth, and an unsteady gait. The pt's neurologist indicated that this may be a reaction to her flu shot.									U	11/04/1999			UNK	OTH	OTH	Phenobarbital, Sinemet	UNK	Parkinson's disease		HQ5766116NOV1999	1						1	Dry mouth; Dysgeusia; Dyspnoea; Gait disturbance; Tremor	FLU3~PFIZER\WYETH~~3~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154012	06/13/2000	NC	51.0	51		F	12/23/1999	A nurse reported that a 51 year old female inadvertently received an overdose of vax. On 11/5/99, she developed flu symptoms. As of 11/12/99, her symptoms persisted.									U	10/29/1999	11/05/1999	7	UNK	PVT	OTH	UNK	UNK	UNK		HQ5768316NOV1999	1						1	Influenza like illness	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154013	06/13/2000	VA				M	01/27/2000	Within 30 minutes, the pt developed blood blisters in his throat and returned to the center where he was immunized. He was instructed to see a physician. He had completed a course of antibiotics for a throat infection approximately 2 weeks prior to immunization.				Y					U	11/13/1999	11/13/1999	0	UNK	OTH	PVT	UNK	NONE	infection, nos		HQ5930117NOV1999	1						1	Oral mucosal blistering; Blister	FLU3~PFIZER\WYETH~4998249~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1693H~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~MERCK & CO. INC.~1693H~1~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0154014	06/13/2000	KY	63.0			F	01/25/2000	Within 10 minutes post vax, the pt developed lightheadedness and felt hot and trembly. She recovered within 90 minutes without treatment.									Y				UNK	PVT	OTH	Vasotec	UNK	multiple allergies		HQ6020118NOV1999	1						1	Dizziness; Tremor; Vasodilation procedure	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154015	06/13/2000	DE	34.0	34		F	11/23/1999	The evening post vax, the pt developed a headache, fatigue, chills, and arthralgia.									U	11/15/1999	11/15/1999	0	UNK	PUB	PUB	NONE	NONE	UNK		HQ6134219NOV1999	1						1	Arthralgia; Chills; Fatigue; Headache	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154016	06/13/2000	VA				F	01/13/2000	Two weeks post vax, the pt experienced a hot sensation on the sole of her left foot and a cold sensation on the top of her right foot.									U				UNK	PVT	OTH	UNK	NONE	UNK		HQ6164219NOV1999	1						1	Feeling cold; Vasodilation procedure	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154017	06/13/2000	IL				F	01/26/2000	Same day post vax, the pt developed injection site pain which radiated throughout her arm. On 10/20/99, she developed an area of redness and warmth at the injection site which was a little larger than a half dollar. On 10/21/99, the redness and pain began to subside, however, the site of vaccination began to itch. On 10/23/99, she experienced dizziness/light-headedness and nausea. Her physician treated her with Zantac and ibuprofen. As of 10/27/99, her light-headedness persisted and worsened upon lying down. The nausea also persisted but was getting better.									Y	10/19/1999	10/19/1999	0	UNK	OTH	OTH	UNK	UNK	UNK		HQ6386123NOV1999	1						1	Dizziness; Injection site hypersensitivity; Injection site pain; Nausea; Pruritus; Vasodilation procedure	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154018	06/13/2000	MD				F	11/23/1999	Same day post vax, the pt developed chest pain. The pt was seen in the ER. This is one of three pts from this facility who experienced an adverse event following receipt of vax.				Y					U	11/04/1999	11/04/1999	0	UNK	OTH	OTH	UNK	UNK	UNK		HQ6502223NOV1999	1						1	Chest pain	FLU3~PFIZER\WYETH~4998245~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0154019	06/13/2000	IN	29.0			F	01/05/2000	Within 24 hours post vax, the pt developed an injection site reaction characterized by an area of redness, pain, and swelling measuring approximately 3 in diameter.									U	11/16/1999	11/17/1999	1	UNK	OTH	OTH	UNK	UNK	UNK		HQ6762629NOV1999	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4998321~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154020	06/13/2000	AR				F	02/03/2000	Post vax, the pt developed chest discomfort described as an elephant on my chest. The pt recovered after 4 to 6 hours. This is one of two pts who experienced this event.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ6853030NOV1999	1						1	Chest pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154021	06/13/2000	IN	29.0			F	01/18/2000	Next day post vax, the pt developed an injection site reaction characterized by an area of redness, swelling, and pain measuring 3 in diameter.									U	11/16/1999	11/17/1999	1	UNK	OTH	OTH	UNK	UNK	UNK		691013	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4998321~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154022	06/13/2000	OH				F	01/18/2000	Within hours post vax, the pt developed itching on her thighs. On 10/28/99, she developed bruises on her legs from her knees up that were a result of scratching. She was seen by a dermatologist, who prescribed oral Benadryl and topical cortisone ointment. The dermatologist noted blisters on her leg, popped one and had the wound cultured. The dermatologist prescribed erythromycin. The itching spread up her stomach and extended to the area under her breasts. She was treated with Zyrtec, Claritin, and cortisone cream which provided some relief.				Y					U	10/25/1999	10/25/1999	0	wound culture-positive for bacteria	OTH	OTH	UNK	UNK	UNK		HQ7046201DEC1999	1						1	Bacterial infection; Blister; Contusion; Pruritus	FLU3~PFIZER\WYETH~4998252~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0154023	06/13/2000	IA	60.0	60		F	01/13/2000	On 11/5/99, the pt developed a rash under her breasts and arms. The pt was seen by the physician on 11/10/99 and reportedly a dx of sinus infection and fungal rash were made. She was prescribed Zithromax and a topical cream. By 11/22/99, her rash extended to her hair and eyes and completely covered her trunk and back. The pustular rash was described as red and itchy, her skin looked mottled. The pt returned to see the physician and was prescribed prednisone. On 11/29/99, she once again saw the physician and unspecified blood work and urinalysis were performed. The pt stated that her rash was drying up and that she had been seen by a dermatologist. The reporter declined to grant permission for follow-up investigation.				Y					U	11/05/1999	11/10/1999	5	UNK	PUB	OTH	Cozaar, Lipitor	NONE	UNK		HQ7158102DEC1999	1						1	Livedo reticularis; Pruritus; Rash pustular; Sinusitis	FLU3~PFIZER\WYETH~~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0154024	06/13/2000	VA				U	01/26/2000	Within hours post vax, the pt developed fever, arthralgias, and a rash which appeared on various parts of the body. A dx of serum sickness was made and the pt was treated with prednisone. Symptoms reoccurred when the prednisone was tapered.									U	10/28/1999	10/28/1999	0	UNK	PVT	OTH	NONE	NONE	UNK		HQ7518206DEC1999	1						1	Arthralgia; Pyrexia; Rash; Serum sickness	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154025	06/13/2000	FL	31.0	31		M	01/06/2000	On 11/8/99, the pt experienced not feeling well and developed chills, nausea and appeared to be diaphoretic. The pt also developed left shoulder pain and weakness of his left arm. That day, the pt was seen in the ER and a dx of labyrinthitis was made. He was prescribed Antivert and referred to an ENT specialist. The pt continues to experience left arm weakness and cannot raise his arm above his head. The pt was referred to a neurologist. This is one of three pts from this facility who experienced an adverse event following receipt of vax.				Y					U	10/27/1999			UNK	OTH	OTH	Allegra	NONE	UNK		HQ7840308DEC1999	1						1	Arthralgia; Chills; Hyperhidrosis; Labyrinthitis; Muscular weakness; Nausea	FLU3~PFIZER\WYETH~4998223~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0154026	06/13/2000	IL	55.0	55		M	01/24/2000	On 12/7/99, the pt developed flu-like symptoms including muscle weakness, scratchy sore throat, slight temperature, and green mucous. On 12/8/99, his throat was so sore that he reportedly could not speak.									U	12/01/1999	12/07/1999	6	UNK	PUB	OTH	NONE	NONE	UNK	similar reaction~Influenza (Seasonal) (FluShield)~`~54.00~In Patient	HQ8190110DEC1999	1						1	Influenza like illness; Muscular weakness; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea	FLU3~PFIZER\WYETH~4998263~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154027	06/13/2000	NY				F	01/14/2000	A nurse reported that an adult female inadvertently received an intradermal injection of Flu Shield instead of PPD. She immediately developed an injection site reaction characterized by induration, redness, and itching. As of 12/29/1999, the redness and itching resolved, the induration persisted. This was the second dose of Flu Shield administered to this pt, the first dose was administered 11/17/99.									U	12/08/1999	12/08/1999	0	UNK	OTH	OTH	NONE	NONE	UNK		HQ8226213DEC1999	1						1	Injection site hypersensitivity; Injection site mass; Pruritus	FLU3~PFIZER\WYETH~4998212~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154028	06/13/2000	NY				F	02/14/2000	The next day post vax, the pt developed an injection site reaction characterized by a 50-mm area of induration, redness, and warmth. This is one of two pts from this facility who experienced an adverse event following receipt of vax. Additional information indicated that the pt developed cellulitis with a fever greater than 101. She was seen by the physician and prescribed Keflex. The pt recovered.				Y					Y	12/09/1999	12/09/1999	0	UNK	OTH	OTH	UNK	NONE	UNK		HQ8308212DEC1999	1						1	Cellulitis; Injection site hypersensitivity; Injection site mass; Pyrexia; Vasodilation procedure	FLU3~PFIZER\WYETH~4998212~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0154029	06/13/2000	WI	28.0	28		F	12/20/1999	A nurse reported that a 28-year-old female received Flu Shield on 10/28/99 and 10/29/99. She developed cellulitis. She was treated with Keflex twice daily. The pt recovered within 5 days. On 12/10/99, the pt developed numbness, tingling, and weakness in most of her affected arm.									U	10/28/1999	12/10/1999	43	UNK	PVT	OTH	Loestrin	NONE	UNK		HQ8312113DEC1999	1						1	Cellulitis; Hypoaesthesia; Muscular weakness	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154030	06/13/2000	IN	49.0			F	12/21/1999	Two days post vax, the pt developed an injection site reaction characterized by a severe hive, itching, and pain which lasted 3 days. The pt then developed a bruise which lasted several days. The pt recovered. This is one of eight pts from this facility who had an adverse experience following receipt of vax.									Y				UNK	OTH	OTH	UNK	NONE	UNK		HQ8682615DEC1999	1						1	Contusion; Injection site pain; Injection site urticaria; Pruritus	FLU3~PFIZER\WYETH~4998272~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154031	06/13/2000	IN	35.0			F	12/22/1999	Subsequently post vax, the pt developed swollen glands, muscle aches, became ill, and developed a small bump at the injection site. The pt recovered. This is one of eight pts from this facility who had an adverse experience following receipt of vax.									Y				UNK	OTH	OTH	UNK	NONE	UNK		HQ8683015DEC1999	1						1	Injection site mass; Lymphadenopathy; Myalgia	FLU3~PFIZER\WYETH~4998272~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154032	06/13/2000	IN	44.0			F	12/22/1999	Subsequently post vax, the pt developed an injection site reaction characterized by a large area of redness, warmth, and itching. Later, the area developed a bruise. The pt recovered. This is one of eight pts from this facility who had an adverse event following receipt of vax.									Y				UNK	OTH	OTH	UNK	NONE	UNK		HQ8683215DEC1999	1						1	Contusion; Injection site hypersensitivity; Pruritus; Vasodilation procedure	FLU3~PFIZER\WYETH~4998272~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154033	06/13/2000	LA	31.0	31		U	01/05/2000	Immediately post vax, pt developed an injection site reaction characterized by a 4  area of redness and warmth.									U	12/22/1999	12/22/1999	0	UNK	OTH	OTH	Niperex, Ventolin	NONE	UNK		HQ9758228DEC1999	1						1	Injection site hypersensitivity; Vasodilation procedure	FLU3~PFIZER\WYETH~~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154034	06/13/2000	KS	35.0	35		F	01/05/2000	Within 10 minutes post vax, pt developed an injection site reaction characterized by an area of erythema measuring 6 cm in diameter with itching. The erythema lasted four days. The pt took Tylenol and recovered. This is one of four pts from this facility who experienced an injection site reaction following receipt of vax.									Y	10/19/1999	10/19/1999	0		PVT	OTH	Buspar, Zocar	NONE	UNK		132304	1						1	Injection site erythema; Pruritus	FLU3~PFIZER\WYETH~4998230~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154035	06/13/2000	KS	57.0	57		F	01/05/2000	Next day post vax, the pt developed an area of erythema at the injection site measuring 6-cm in diameter. The erythema lasted 48 hours and resolved without treatment. The pt recovered. This is one of four pts from this facility who developed an injection site reaction following receipt of vax.									Y	10/19/1999	10/20/1999	1		PVT	OTH	Atenolol,Cycrin	NONE	mitral valve prolapse		HQ0132404JAN2000	1						1	Injection site erythema	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154036	06/13/2000	KS	42.0	42		F	01/05/2000	The next day post vax, the pt developed fever at the injection site which lasted 72 hours. The pt recovered without treatment. This is one of four pts from this facility who had an injection site reaction following receipt of vax.									Y	10/19/1999	10/20/1999	1		PVT	OTH	Premarin	NONE	UNK		HQ0132504JAN2000	1						1	Vasodilation procedure	FLU3~PFIZER\WYETH~4998230~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154037	06/13/2000	MO	52.0	52		F	01/12/2000	Next day post vax, the pt developed an injection site reaction characterized by swelling, redness, and a rash. This is one of three employees from this facility who experienced this event following receipt of vax.									U	10/21/1999	10/22/1999	1	UNK	OTH	OTH	UNK	UNK	UNK		HQ0432612JAN2000	1						1	Injection site hypersensitivity; Injection site oedema; Rash	FLU3~PFIZER\WYETH~4998257~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154038	06/13/2000	MO	54.0	54		F	01/12/2000	Two days post vax, the pt developed an injection site reaction characterized by swelling, redness, and a rash. This is one of three employees from this facility who experienced this event following receipt of vax.									U	10/20/1999	10/22/1999	2	UNK	OTH	OTH	UNK	UNK	UNK		HQ0432712JAN2000	1						1	Injection site hypersensitivity; Injection site oedema; Rash	FLU3~PFIZER\WYETH~4998257~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154039	06/13/2000	CA				U	01/11/2000	Post vax, the pt developed a large area of swelling at the injection site.									Y					OTH	OTH	UNK	UNK	UNK		HQ0610628SEP1999	1						1	Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154040	06/13/2000	CA				U	01/27/2000	Immediately post vax, the pt developed an injection site reaction described as cellulitis. The reporter indicated that 2 employees experienced this event, however, they are not presently identifiable.									U	10/11/1999	10/11/1999	0	UNK	PVT	OTH	UNK	UNK	UNK		HQ0710724JAN2000	1						1	Cellulitis; Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154041	06/13/2000	MN				F	02/25/2000	Post vax, the pt felt horrible. The reporter declined to provide additional information and has declined to grant permission for follow-up investigation.									U					OTH	OTH	Enbrel, Methotrexate	UNK	rheumatoid arthritis		HQ1184223FEB2000	1						1	Feeling abnormal	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154042	06/13/2000	VA				U	10/13/1999	Subsequently post vax, the pt developed injection site soreness.									U				UNK	PVT	OTH	UNK	UNK	UNK		HQ1876111OCT1999	1						1	Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154043	06/13/2000	TX				U	01/18/2000	A pharmacist reported that a pt received the vaccine on 10/6/99 and subsequently developed an injection site reaction characterized by redness, warmth, discomfort and a burning sensation during the injection. The pt could actually feel the medication spreading after it was given. The pt recovered within 24 hours. The reported indicated that 10 pt's experienced this event, however they are not presently identifiable. Additional reports will be generated when information is provided. This is 1 of 2 reports from this facility of adverse experiences following the receipt of Flu Shield lot number 4998257.									Y	10/06/1999			UNK	PVT	OTH	UNK	UNK	UNK		HQ2050211OCT1999	1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~PFIZER\WYETH~4998257~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154044	06/13/2000	VA				F	11/15/1999	Within 45 minutes post vax, the pt developed muscle pain and soreness. This is one of three pts from this facility who experienced this event following receipt of vax.									Y	10/06/1999	10/06/1999	0	UNK	OTH	OTH	UNK	NONE	UNK		HQ2110212OCT1999	1						1	Myalgia	FLU3~PFIZER\WYETH~4998272~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154045	06/13/2000	VA				F	11/15/1999	Within 45 minutes post vax, the pt developed muscle pain and soreness. This is one of three pts from this facility who experienced this event following receipt of vax.									Y	10/06/1999	10/06/1999	0	UNK	OTH	OTH	UNK	NONE	UNK		HQ2110312OCT1999	1						1	Myalgia	FLU3~PFIZER\WYETH~4998272~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154046	06/13/2000	MI	45.0	45		F	01/26/2000	Same day post vax, the pt developed soreness at the injection site almost immediately. The site was massaged. That night, the soreness increased.									U	10/07/1999	10/07/1999	0	UNK	PVT	PVT	NONE	NONE	UNK		HQ2170112OCT1999	1						1	Injection site pain	FLU3~PFIZER\WYETH~~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154047	06/13/2000	AK	52.0	52		F	11/18/1999	The following day post vax, the pt developed a 5-cm erythematous, warm-to-touch wheal at the site of administration.									Y	10/04/1999	10/05/1999	1	UNK	PVT	OTH	NONE	UNK	UNK		HQ2198412OCT1999	1						1	Injection site urticaria; Vasodilation procedure	FLU3~PFIZER\WYETH~4998222~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154048	06/13/2000	LA	47.0	47		F	10/28/1999	Within 30 minutes post vax, the pt developed a burning sensation in her sinuses. On 10/10/99, she developed left facial paralysis. She was seen by the physician and a dx of Bell's Palsy was made. The facial paralysis persists.				Y					N	10/06/1999	10/10/1999	4	UNK	PVT	OTH	NONE	NONE	UNK		HQ2198512OCT1999	1						1	Facial palsy; Headache	FLU3~PFIZER\WYETH~4998287~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0154049	06/13/2000	GA				U	01/18/2000	Same day post vax, the pt developed an injection site reaction characterized by pain, heat, erythema, and swelling.									U	10/11/1999	10/11/1999	0	UNK	PVT	OTH	UNK	NONE	UNK		HQ2274213OCT1999	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilation procedure	FLU3~PFIZER\WYETH~4998274~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154050	06/13/2000	TX	24.0	24		F	11/16/1999	A pharmacist reported that a 24 year old pt received Flu Shield on 10/9;99 and within hours developed an injection site reaction characterized by pain, warmth, swelling and a 2 inch area of redness. The pt recovered within 3 - 4 days. this is 1 of 2 pt's from this facility who experienced an injection site reaction following receipt of Flu Shield lot number 4998231. Additional information received on 11/1/99 indicated the gender of the pt and the county of vaccine administration.									U	10/09/1999	10/09/1999	0		OTH	PVT	UNK	UNK	UNK		HQ2354113OCT1999	1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLU3~PFIZER\WYETH~4998231~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154051	06/13/2000	IN	27.0			F	12/21/1999	Next day post vax, the pt developed an injection site reaction characterized by redness, warmth, and a large hive. The pt recovered. This is one of eight pts from this facility who had an adverse experience following receipt of vax.									Y					OTH	OTH	UNK	NONE	UNK		HQ2472314OCT1999	1						1	Injection site urticaria; Vasodilation procedure	FLU3~PFIZER\WYETH~4998272~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154052	06/13/2000	IA				U	10/20/1999	Same day post vax, the pt developed an injection site reaction characterized by an area of pain, redness, and induration the size of a half dollar.									U	10/11/1999	10/11/1999	0	UNK	PUB	OTH	UNK	UNK	UNK		HQ2474314OCT1999	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~PFIZER\WYETH~4998215~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154053	06/13/2000	AK	32.0	32		F	01/24/2000	Two days post vax, the pt developed myalgia and prolonged pain at the injection site. She recovered. The pt later reported that she had been lifting a lot of boxes and considered that to be the cause of the pain.									Y	10/05/1999	10/07/1999	2	NONE	OTH	OTH	NONE		UNK		HQ2476514OCT1999	1						1	Injection site pain; Myalgia	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154054	06/13/2000	TN	20.0			F	10/28/1999	Post vax, the pt took Tylenol but subsequently developed an achy, high fever. This is one of three pts from this facility who had an adverse experience following receipt of vax.									U	10/12/1999	10/12/1999	0	UNK	PVT	OTH	UNK	NONE	UNK		HQ2550214OCT1999	1						1	Pain; Pyrexia	FLU3~PFIZER\WYETH~4998224~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154057	06/13/2000	MD	35.0	34		F	01/17/2000	Within 24 hours post vax, the pt developed an injection site reaction characterized by swelling, redness, and induration. This is one of two pts from this facility who developed an injection site reaction following receipt of vax.									U	10/13/1999	10/14/1999	1	UNK	PVT	PVT	UNK	NONE	UNK		HQ2572414OCT1999	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~PFIZER\WYETH~4998274~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154058	06/13/2000	MD	36.0	36		F	12/07/1999	Within 24 hours post vax, the pt developed an injection site reaction characterized by erythema, induration, and swelling. She was seen by the physician who prescribed a Medrol Dosepak. This is one of two pts from this facility who developed an injection site reaction following receipt of vax.				Y					U	10/11/1999	10/12/1999	1	UNK	PVT	PVT	multi-vitamins, PPD	NONE	UNK		HQ2574514OCT1999	1						1	Injection site erythema; Injection site mass; Injection site oedema	FLU3~PFIZER\WYETH~4998274~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0154059	06/13/2000	TX	32.0	32		F	01/18/2000	Same day post vax, the pt developed an injection site reaction characterized by tenderness and induration. The pt recovered.									Y	10/11/1999	10/11/1999	0	UNK	PVT	OTH	UNK	NONE	drug hypersensitivity		HQ2614015OCT1999	1						1	Injection site mass; Injection site pain	FLU3~PFIZER\WYETH~4998282~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~U0011AA~UNK~IM~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0154060	06/13/2000	MI				U	01/27/2000	Within minutes post vax, the pt developed an injection site reaction characterized by pain, redness, and swelling. The physician prescribed applications of ice and antihistamines.									U				UNK	PVT	OTH	UNK	UNK	UNK		HQ2622218OCT1999	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4998244~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154061	06/13/2000	CT				F	10/19/1999	Within one to two hours post vax, the pt developed an injection site reaction characterized by severe swelling, redness, and warmth extending from her elbow to her shoulder. The symptoms lasted 4 to 5 days and resolved without treatment.									Y				UNK	PUB	OTH	UNK	NONE	UNK		HQ2622918OCT1999	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilation procedure	FLU3~PFIZER\WYETH~~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154062	06/13/2000	VA	57.0	57		U	11/01/1999	On 10/15/99, the pt developed an itchy, red rash which extended over the entire body.									U	10/08/1999	10/15/1999	7	UNK	OTH	OTH	Premarin, vitamins	UNK	drug hypersensitivity		HQ2625118OCT1999	1						1	Pruritus; Rash	FLU3~PFIZER\WYETH~4998293~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154069	06/13/2000	WI				U	11/15/1999	Subsequently post vax, the pt developed a bulls eye rash with a red ring around the injection site. This is one of two pts who experienced this event following receipt of vax.									Y				UNK	PUB	OTH	UNK	UNK	UNK		HQ2640218OCT1999	1						1	Injection site rash	FLU3~PFIZER\WYETH~4998217~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154072	06/13/2000	CA	56.0	56		F	01/27/2000	A physician reported that a 36 year old female received the vaccine on 10/11/99. On 10/15/99, she developed an injection site reaction characterized by redness and swelling which extended to the elbow. She also developed a low-grade fever of 99.8. The pt was treated with antibiotics and antihistamines. She recovered.									Y	10/11/1999	10/15/1999	4	UNK	PVT	OTH	Premarin, Prempro	NONE	UNK		HQ2646318OCT1999	1						1	Injection site erythema; Injection site oedema; Pyrexia	FLU3~PFIZER\WYETH~4998273~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154074	06/13/2000					F	11/02/1999	Within 30 minutes post vax, the pt developed an injection site reaction characterized by redness and pain. The pt stated that the vaccine was injected into the side of the arm rather than the deltoid.									U	10/04/1999	10/04/1999	0	UNK	OTH	OTH	UNK	UNK	UNK		HQ2726218OCT1999	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154075	06/13/2000	KS	45.0	45		F	11/16/1999	A nurse reported that a 45 year old female received the Flu Shield on 10/13/99 and subsequently developed a low grade fever and an injection site reaction characterized by swelling, redness and itching. On 10/15/99, the pt was seen by the physician. Additional information received 11/11/99 from the physician indicated that as of 11/5/99, the pt's symptoms resolved, however, she subsequently developed a lump the size of a pea at the injection site.				Y					Y	10/13/1999			UNK	OTH	OTH	UNK	NONE	UNK		HQ2794119OCT1999	1						1	Injection site erythema; Injection site mass; Injection site oedema; Pruritus; Pyrexia	FLU3~PFIZER\WYETH~4998277~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0154077	06/13/2000	TX	43.0			F	01/13/2000	A pharmacist reported that a 43 year old female received an injection of Flu Shield. Within 24 hours, she developed an injection site reaction characterized by redness, swelling, warmth and a knot the size of a softball. As of 10/18/99, the swelling had begun to subside. This is 1 of 3 pt's from this facility who developed an injection site reaction following receipt of Flu Shield.									U				UNK	OTH	PVT	UNK	NONE	UNK		HQ2796219OCT1999	1						1	Injection site erythema; Injection site mass; Injection site oedema; Injection site warmth	FLU3~PFIZER\WYETH~4998287~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154080	06/13/2000	NY	78.0			F	01/26/2000	On 10/16/99, the pt developed a fever of 103.									U	10/14/1999	10/16/1999	2	UNK	OTH	OTH	UNK	UNK	encephalitis		HQ2992520OCT1999	1						1	Pyrexia	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154082	06/13/2000	NM				U	10/25/1999	Immediately post vax, the pt experienced stinging upon administration. The symptoms resolved soon after the administration.									Y				UNK	PVT	OTH	UNK	UNK	UNK		300222	1						1	Pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154083	06/13/2000	CT				U	01/18/2000	Same day post vax, the pt developed a more than usual soreness at the injection site. Additionally, two pts had inflamed shoulders and could not lift their arms. This is one of two reports from this facility of adverse event following receipt of vax.									U				UNK	PVT	PVT	UNK	NONE	UNK		HQ3200122OCT1999	1						1	Arthritis; Hypokinesia; Injection site pain	FLU3~PFIZER\WYETH~4998229~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154084	06/13/2000	OH				U	01/12/2000	Within hours post vax, the employee developed a large injection site reaction characterized by redness and swelling. The reporter indicated that 13 employees were vaccinated; 8 experienced this event.									U	10/14/1999	10/14/1999	0	UNK	PVT	OTH	UNK	UNK	UNK		HQ3298122OCT1999	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4998215~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154085	06/13/2000	WV	47.0	47		U	01/24/2000	Next day post vax, the pt developed an injection site reaction characterized by redness, inflammation, swelling, and warmth.									U	10/20/1999	10/21/1999	1	UNK	PUB	OTH	NONE	NONE	UNK		HQ3360225OCT1999	1						1	Injection site hypersensitivity; Injection site inflammation; Injection site oedema; Vasodilation procedure	FLU3~PFIZER\WYETH~4998223~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154086	06/13/2000	TN	24.0	24		F	01/18/2000	Subsequently post vax, the pt developed an injection site reaction characterized by redness, warmth, and discomfort. The pt recovered.									Y	10/20/1999			UNK	PVT	PVT	UNK	NONE	UNK		HQ3382125OCT1999	1						1	Injection site hypersensitivity; Injection site pain; Vasodilation procedure	FLU3~PFIZER\WYETH~4998293~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154087	06/13/2000	MO	26.0	26		F	01/12/2000	Two days post vax, the pt developed an injection site reaction characterized by swelling, redness, and a rash. This is one of three employees from this facility who experienced this event following receipt of vax.									U	10/20/1999	10/22/1999	2	UNK	OTH	OTH	UNK	UNK	UNK		HQ3418525OCT1999	1						1	Injection site hypersensitivity; Injection site oedema; Rash	FLU3~PFIZER\WYETH~4998257~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154088	06/13/2000	KY				F	01/26/2000	A pharmacist reported that a pt attending a health fair received an injection of Flu Shield. On 10/24/99. The next day, the pt developed an injection site reaction characterized by an area of redness, swelling and warmth up to six inches in diameter. She was treated with diphenhydramine  and applications of ice; She recovered. The reporter states that 6 pt's experienced this event; however, only one could be identified. All pt's were treated with diphenhydramine and applications of ice and all pt's recovered.									Y	10/23/1999	10/24/1999	1	UNK	OTH	OTH	UNK	UNK	UNK		346252	1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~PFIZER\WYETH~4998222~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154089	06/13/2000					U	11/02/1999	Text states that this is a duplicate of mfr # HQ2472314OCT1999									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ3472225OCT1999	1						1	Unevaluable event	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154091	06/13/2000	TX	19.0			F	01/12/2000	Within 24 hours post vax, the pt developed an injection site reaction characterized by an area of redness and swelling the size of a baseball.									U				UNK	OTH	PVT	UNK	NONE	UNK		HQ3494125OCT1999	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4998287~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154092	06/13/2000	TX				F	01/18/2000	Within 24 hours post vax, the pt developed an injection site reaction characterized by an area of redness, swelling, and induration the size of a baseball. As of 10/18/99, the redness and swelling had subsided some.									U	10/14/1999	10/15/1999	1	UNK	OTH	PVT	UNK	NONE	UNK		HQ3494225OCT1999	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~PFIZER\WYETH~4998287~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154093	06/13/2000	KS	35.0	35		F	01/05/2000	Within 5 hours post vax, the pt developed an injection site reaction characterized by warmth and an area of erythema measuring 3 cm in diameter. The area of redness developed within 24 hours of administration and lasted 4 days. The pt recovered without treatment.									Y	10/19/1999	10/19/1999	0	NONE	PVT	OTH	Loestrin	NONE	UNK		HQ3544426OCT1999	1						1	Injection site erythema; Vasodilation procedure	FLU3~PFIZER\WYETH~4998230~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154094	06/13/2000	WA	57.0			U	01/12/2000	Subsequently post vax, the pt developed persistent arm pain and tenderness at the injection site. The pt was seen by the vaccine provider, who prescribed analgesics and non-steroidal anti-inflammatory drugs, they produced little or no response.				Y					U	10/12/1999	10/12/1999	0	UNK	PVT	OTH	NONE	NONE	UNK		HQ3650626OCT1999	1						1	Injection site pain	FLU3~PFIZER\WYETH~4998216~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0154095	06/13/2000	CT	24.0			F	12/09/1999	Next day post vax, the pt developed an injection site reaction characterized by redness, swelling, and warmth. The pt recovered.									Y	10/20/1999	10/21/1999	1	UNK	PVT	OTH	UNK	NONE	UNK		HQ3732127OCT1999	1						1	Injection site hypersensitivity; Injection site oedema; Vasodilation procedure	FLU3~PFIZER\WYETH~4998209~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154096	06/13/2000	CT	50.0			F	11/22/1999	Next day post vax, the pt developed an injection site reaction characterized by redness and swelling. The pt recovered.									Y	10/21/1999	10/22/1999	1	UNK	PVT	OTH	Motrin, Premarin	NONE	UNK		HQ3768127OCT1999	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4998209~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154097	06/13/2000	TX	40.0	40		F	01/26/2000	Next day post vax, the pt developed an injection site reaction characterized by redness and a knot. She recovered.									Y	10/20/1999	10/21/1999	1	UNK	PUB	OTH	UNK	UNK	UNK		HQ3860128OCT1999	1						1	Injection site hypersensitivity; Injection site mass	FLU3~PFIZER\WYETH~4998281~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154098	06/13/2000	TN				U	01/26/2000	Subsequently post vax, the pt developed an injection site reaction characterized by redness and swelling. The pts and employees recovered.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ4010129OCT1999	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4998226~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154099	06/13/2000	TX				U	01/26/2000	Subsequently post vax, the pt developed an injection site reaction characterized by a large area of redness and swelling.									U	10/26/1999	10/26/1999	0	UNK	OTH	OTH	UNK	UNK	UNK		HQ4014229OCT1999	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4998269~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154100	06/13/2000	IN				U	01/11/2000	Subsequently post vax, the pt developed an injection site reaction characterized by a large area of redness and swelling.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ4096101NOV1999	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4998272~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154101	06/13/2000	NE				U	11/15/1999	Subsequently post vax, the pt developed myalgia. This is one of many pts from this facility who experienced this event following receipt of vax.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ4146301NOV1999	1						1	Myalgia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154103	06/13/2000	CA				F	01/24/2000	Within one hour, the pt developed generalized itching and a welt on the injection site, elbow, and each leg. She was treated with oral Benadryl and recovered.									Y	10/27/1999	10/27/1999	0	UNK	PVT	PVT	UNK	NONE	UNK		HQ4438203NOV1999	1						1	Pruritus	FLU3~PFIZER\WYETH~4998230~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154104	06/13/2000	UT	56.0	57		F	11/16/1999	On 10/13/99, the pt developed brachial neuritis. She was seen by the physician. The pt was prescribed an unspecified pain medication and NSAID.				Y					U	10/06/1999	10/13/1999	7	arm x-ray-neg	OTH	OTH	NONE	NONE	UNK		HQ4718305NOV1999	1						1	Neuropathy peripheral	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0154105	06/13/2000	IL				U	12/07/1999	Subsequently post vax, the pt developed an injection site reaction characterized by redness and swelling. The redness and swelling improved within 4 to 5 days with local treatment.									U				NONE	PVT	OTH	UNK	UNK	UNK		HQ4720105NOV1999	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154106	06/13/2000	OH				U	01/18/2000	Subsequently post vax, the pt developed an injection site reaction characterized by erythema and swelling.									U				UNK	OTH	OTH	UNK	UNK	UNK		488620	1						1	Injection site erythema; Injection site oedema	FLU3~PFIZER\WYETH~4998215~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154107	06/13/2000	NH	49.0			F	11/15/1999	The pt stated that the night before the vaccine was administered she experienced 2 asthma attacks and used asthma inhalers. Within 20 minutes of vaccine administration, she developed an injection site reaction characterized by swelling, warmth, and skin discoloration described as purple/pink. She then developed a generalized rash that looked like German measles and chicken pox. She was prescribed cortisone ointment and Claritin. Later, she was prescribed 3 stronger antihistamines because the rash did not resolve.									U				UNK	PVT	OTH	UNK	NONE	asthma		HQ5134410NOV1999	1						1	Injection site oedema; Rash; Skin discolouration; Vasodilation procedure	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154108	06/13/2000	CA				F	01/17/2000	Within 30 minutes post vax, the pt developed hives at the injection site and intense generalized itching. She was seen in the ER and recovered within 90 minutes without treatment.				Y					Y	10/29/1999	10/29/1999	0	UNK	PVT	PVT	UNK	NONE	UNK		HQ5242310NOV1999	1						1	Injection site urticaria; Pruritus	FLU3~PFIZER\WYETH~4998230~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0154109	06/13/2000	OH				U	01/13/2000	Subsequently post vax, the pt developed an injection site reaction characterized by erythema, swelling, and itching. The pt recovered.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ5822116NOV1999	1						1	Injection site erythema; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4998215~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154110	06/13/2000	MN				U	01/26/2000	Subsequently post vax, the pt developed an injection site reaction that extended down the pt's arm. No further information was available at the date of this report.									U				UNK	PUB	OTH	UNK	UNK	UNK		HQ6036618NOV1999	1						1	Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154111	06/13/2000	CO				U	02/15/2000	Subsequently post vax, the pt developed an injection site reaction characterized by redness and soreness.									U				UNK	PVT	OTH	UNK	UNK	UNK		HQ6262122NOV1999	1						1	Injection site hypersensitivity; Injection site pain	FLU3~PFIZER\WYETH~4998259~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154112	06/13/2000	WI				U	11/30/1999	Subsequently post vax, the pt developed redness at the injection site.									U				UNK	OTH	PVT	UNK	NONE	UNK		HQ6504323NOV1999	1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154113	06/13/2000		85.0			F	05/03/2000	Subsequently post vax, the pt developed an allergic reaction. The pt recovered.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ6688124NOV1999	1						1	Hypersensitivity	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154114	06/13/2000	AL	61.0	61		U	12/20/1999	Next day post vax, the pt developed swelling in the affected arm.									U	10/28/1999	10/29/1999	1	UNK	PVT	OTH	Premarin	NONE	UNK		HQ6836230NOV1999	1						1	Oedema peripheral	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154115	06/13/2000	KY	39.0	39		F	12/21/1999	Same day post vax, the pt developed pain at the injection site.									U	11/19/1999	11/19/1999	0	UNK	PVT	OTH	UNK	NONE	UNK		HQ6840130NOV1999	1						1	Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154116	06/13/2000	LA	30.0	30		F	01/18/2000	Same day post vax, the pt developed an injection site reaction characterized by an area of redness, edema, and hardness the size of a grapefruit. The pt reportedly could not move the affected arm.									U	11/20/1999	11/20/1999	0	UNK	PVT	OTH	Beconase, Claritin	NONE	UNK		HQ6848230NOV1999	1						1	Hypokinesia; Injection site hypersensitivity; Injection site mass; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154117	06/13/2000	ID				U	01/13/2000	Within two weeks post vax, the pt developed a rash at the injection site.									U				UNK	PVT	OTH	UNK	UNK	UNK		HQ7524106DEC1999	1						1	Injection site rash	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0154118	06/13/2000	IL				U	12/07/1999	Subsequently post vax, the pt developed an injection site reaction characterized by redness and swelling. The redness and swelling improved with local treatment.									U				UNK	PVT	OTH	UNK	UNK	UNK		HQ7592106DEC1999	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154119	06/13/2000	ME	57.0			U	12/08/1999	On 11/26/99, the pt developed injection site itching which intensified for the past week.									U	10/20/1999	11/26/1999	37	UNK	PVT	OTH	Naprosyn	NONE	UNK		HQ7610607DEC1999	1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154120	06/13/2000	IL				M	12/23/1999	Within a week and a half post vax, the pt developed a generalized rash. The pt consulted the dermatologist.									U				UNK	OTH	OTH	aspirin, Lipitor	UNK	UNK		HQ7652207DEC1999	1						1	Rash	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0154121	06/13/2000	FL	43.0	42		F	01/11/2000	On 10/22/99, the pt developed right deltoid pain and right shoulder and arm weakness. The pt was unable to lift her arm above her head. She also developed a nodule at the injection site. On 11/10/99, the pt was seen by the nurse practitioner who prescribed ibuprofen, warm soaks and referred the pt to an occupational therapist.				Y					U	10/12/1999	10/22/1999	10	UNK	OTH	PVT	NONE	NONE	UNK		HQ7746107DEC1999	1						1	Hypokinesia; Injection site mass; Muscular weakness; Pain	FLU3~PFIZER\WYETH~4998223~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0154122	06/13/2000	FL	54.0	54		M	01/06/2000	On 10/19/99, the pt developed generalized weakness, left arm weakness, and left deltoid pain. The pt was seen by the nurse practitioner and prescribed ibuprofen and referred to an occupational therapist.				Y					U	10/12/1999	10/19/1999	7	UNK	OTH	PVT	NONE	NONE	UNK		HQ7838208DEC1999	1						1	Asthenia; Muscular weakness; Pain	FLU3~PFIZER\WYETH~4998223~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0154123	06/13/2000	IL				U	02/25/2000	Subsequently post vax, the pt developed an injection site reaction characterized by swelling and stiffness.									U				UNK	PVT	OTH	UNK	UNK	UNK		HQ8318113DEC1999	1						1	Injection site oedema; Musculoskeletal stiffness	FLU3~PFIZER\WYETH~4998263~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154124	06/13/2000	IN	54.0			F	12/21/1999	Immediately following administration of vax, the pt developed severe itching. The pt recovered.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ8682415DEC1999	1						1	Pruritus	FLU3~PFIZER\WYETH~4998272~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154125	06/13/2000	IN	58.0			F	12/21/1999	Subsequently post vax, the pt developed some itching. The pt recovered.									Y				UNK	OTH	OTH	UNK	NONE	UNK		HQ8682515DEC1999	1						1	Pruritus	FLU3~PFIZER\WYETH~4998272~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154126	06/13/2000	IN	53.0			F	12/21/1999	Subsequently post vax, the pt developed arm pain which lasted 2 to 3 days. The pt recovered.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ8682815DEC1999	1						1	Pain	FLU3~PFIZER\WYETH~4998272~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154127	06/13/2000	IN	56.0			F	12/21/1999	Subsequently post vax, the pt developed arm pain which lasted several days. The pt recovered.									Y				UNK	OTH	OTH	UNK	NONE	UNK		HQ8682915DEC1999	1						1	Pain	FLU3~PFIZER\WYETH~4998272~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154212	06/14/2000	OR	36.0	35		M	06/06/2000	Employer sent me to Health Dept for Hepatitis shot but Health Dept gave me a Flu shot, instead. I got very ill and had to spend 7 days in the hospital. The doctor's dx is Guillain-Barre' Syndrome (GBS). I have not recovered; lung and breathing problems.			Y	Y	Y	7		Y	N	12/16/1999	12/24/1999	8		PUB	OTH		NONE	NONE			1						1	Dyspnoea; Guillain-Barre syndrome; Lung disorder; Asthenia; Dysphonia; Dyspnoea; Guillain-Barre syndrome; Pain; Paralysis	FLU3~PARKDALE PHARMACEUTICALS~028389P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~02089P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0154223	06/14/2000	HI	19.0	19		M	06/02/2000	Vaxs received on 02/08/2000. Around 11 PM that evening, he awoke with vomiting, diarrhea, dizziness, lots of sweating and felt hot The symptoms lasted for about 5 days. Pt continued to have dizzy spells , but were not severe enough to restrict his activity. On 03/12, he developed syncopal episode and consequently, he had several episodes lasting for 3-30 minutes. He underwent complete neurological and cardiac work-up, which was negative. He was seen by an endocrinologist, and a diagnosis of orthostatic hypotension with tachycardia secondary to post-inflammatory neuronitis was made. Since the onset of febrile illness and shot preceded the symptoms, it is likely that this was due to one of the vaxs he received on 02/08. He has improved with volume load and Florinef and has not had any more syncopal attacks. The follow up states, info is not available, the vaccines were given at a different facility, they did not record the lot numbers.				Y					N	02/08/2000	02/08/2000	0	Neurological and cardiac work-up.	MIL	MIL	NONE	NONE	NONE			1						1	Diarrhoea; Dizziness; Hyperhidrosis; Neuritis; Orthostatic hypotension; Pyrexia; Syncope; Tachycardia; Vasodilation procedure; Vomiting	ANTH~MICHIGAN DEPT PUB HLTH~FAV041~2~SC~~ANTHRAX (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~MERCK & CO. INC.~~1~IM~~HEP B (FOREIGN)~1|TYP~CONNAUGHT LABORATORIES~~1~IM~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|YF~CONNAUGHT LABORATORIES~~1~SC~~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0129467	06/15/2000	MD	74.0	74		M	10/14/1999	pt w/sudden onset of jerky movements-involuntary @ trunk area & arms;				Y					Y	10/14/1999	10/14/1999	0		OTH	UNK	Cardarone;ASA;Flovent	NONE	hx A-fib;prostate CA	~ ()~~~In patient		1						1	Muscle twitching; Muscle twitching	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0129467	06/15/2000	MD	74.0	74		M	10/14/1999	pt w/sudden onset of jerky movements-involuntary @ trunk area & arms;				Y					Y	10/14/1999	10/14/1999	0		OTH	UNK	Cardarone;ASA;Flovent	NONE	hx A-fib;prostate CA	~ ()~~~In patient		1						2	Muscle twitching; Muscle twitching	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0130270	06/15/2000	MD	65.0	65		F	10/28/1999	pt exp chills, fever, soreness in throat, some diff breathing, elevated temp & h/a;sx cont 20hr later w/x/to temp now nl;									Y	10/27/1999	10/27/1999	0	NONE	PUB	PUB	NONE	NONE	unk	pt exp rxn @ age 23 w/flu vax;~ ()~~~In patient		1						1	Chills; Dyspnoea; Headache; Pharyngitis; Pyrexia; Chills; Dyspnoea; Headache; Pharyngitis; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~01989P~4~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~01989P~4~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0130270	06/15/2000	MD	65.0	65		F	10/28/1999	pt exp chills, fever, soreness in throat, some diff breathing, elevated temp & h/a;sx cont 20hr later w/x/to temp now nl;									Y	10/27/1999	10/27/1999	0	NONE	PUB	PUB	NONE	NONE	unk	pt exp rxn @ age 23 w/flu vax;~ ()~~~In patient		1						2	Chills; Dyspnoea; Headache; Pharyngitis; Pyrexia; Chills; Dyspnoea; Headache; Pharyngitis; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~01989P~4~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~01989P~4~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0131389	06/15/2000	MD	49.0	49		F	11/03/1999	40 mins post vax pt experienced swelling of the lips and felt her voice changed. Left side of neck became red and blotchy.  Pt took benadryl and was examine by site MD. MD states throat was not swollen and vital signs stable.				Y					Y	10/21/1999	10/21/1999	0	NONE	PUB	PUB	estrae, detrol, bp meds	NONE		~ ()~~~In patient		1						2	Dysphonia; Face oedema; Rash maculo-papular; Vasodilatation; Dysphonia; Face oedema; Rash maculo-papular; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02979P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2|FLU3~PARKDALE PHARMACEUTICALS~02979P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~3	USA	Emergency room visit	Influenza
0131389	06/15/2000	MD	49.0	49		F	11/03/1999	40 mins post vax pt experienced swelling of the lips and felt her voice changed. Left side of neck became red and blotchy.  Pt took benadryl and was examine by site MD. MD states throat was not swollen and vital signs stable.				Y					Y	10/21/1999	10/21/1999	0	NONE	PUB	PUB	estrae, detrol, bp meds	NONE		~ ()~~~In patient		1						3	Dysphonia; Face oedema; Rash maculo-papular; Vasodilatation; Dysphonia; Face oedema; Rash maculo-papular; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02979P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2|FLU3~PARKDALE PHARMACEUTICALS~02979P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~3	USA	Emergency room visit	Influenza
0131920	06/15/2000	MD	53.0	53		F	11/23/1999	Sore arm, aching joints, tiredness and eyes hurt. No knowledge of temperature. Aching joints, hips, wrist, knees more at night. Resolved 11/21.									Y	11/12/1999	11/15/1999	3	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MD99031	1						2	Arthralgia; Asthenia; Eye pain; Pain; Arthralgia; Asthenia; Eye pain; Pain	FLU3~PARKDALE PHARMACEUTICALS~02289P~7+~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2|FLU3~PARKDALE PHARMACEUTICALS~02289P~7+~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~3	USA		Influenza
0131920	06/15/2000	MD	53.0	53		F	11/23/1999	Sore arm, aching joints, tiredness and eyes hurt. No knowledge of temperature. Aching joints, hips, wrist, knees more at night. Resolved 11/21.									Y	11/12/1999	11/15/1999	3	NONE	PUB	PUB	NONE	NONE	NONE	NONE~ ()~~~In patient	MD99031	1						3	Arthralgia; Asthenia; Eye pain; Pain; Arthralgia; Asthenia; Eye pain; Pain	FLU3~PARKDALE PHARMACEUTICALS~02289P~7+~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2|FLU3~PARKDALE PHARMACEUTICALS~02289P~7+~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~3	USA		Influenza
0132166	06/15/2000	MD	52.0	52		F	12/10/1999	Soreness began in left arm immediately following injection and more than usual discomfort persisted into the evening. Pt took Aleve and it seemed to improve. On or about 11/15 - 11/16/1999 it reoccurred causing discomfort when lifting her arm. On 11/18/1999 neck stiffness developed.  Soreness to date is still present when raising arm.									Y	11/08/1999	11/08/1999	0	NONE	PUB	PUB	Hydroxyurea, Flonase	NONE	Thrombocytopenia, blood disorder, too many platelets		FLU2351299	1						2	Hypokinesia; Injection site pain; Nuchal rigidity; Pain	FLU3~PARKDALE PHARMACEUTICALS~02289P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0154262	06/15/2000	MT				F	11/19/1999	Reported subcutaneous crepitus, soreness at injection site that lasted for 24 hours.									Y	10/25/1999			UNK	PVT	PVT	OCP	UNK	NONE		FLU2281199	1						1	Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~01889P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0154263	06/15/2000	IL	20.0	20		F	01/14/2000	Pt reported local inflammation at subcutaneous injection site.									Y	01/06/2000	01/06/2000	0		PVT	PVT	UNK	UNK	UNK		FLU2251199	1						1	Injection site inflammation	FLU3~PARKDALE PHARMACEUTICALS~4099P~1~SC~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0154264	06/15/2000	PA	45.0	43		F	12/06/1999	Pt experienced deep atrophy left deltoid muscle with dark brown discoloration and deep indentation (1/4 inch) scarring in the center at injection site.									Y	11/01/1999	11/01/1999	0	NONE	PVT	PVT	NONE	NONE	NONE		FLU2321299	1						1	Injection site atrophy; Scar; Skin discolouration	FLU3~PARKDALE PHARMACEUTICALS~03179P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0154265	06/15/2000	KY	47.0	46		F	01/19/2000	Pt experience pain from injection site to elbow; constant pain when driving and painful at night.									Y	11/09/1999	11/09/1999	0	UNK	PVT	PVT	UNK	UNK	PCN allergy		FLU2261199	1						1	Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~02289P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0154266	06/15/2000	MI				F	12/30/1999	Pt experienced chest pain/tightness three hours post vax that lasted for three to four hours.									Y	11/30/1999	11/30/1999	0	EKG - Nml sinus rhythm	UNK	UNK	UNK	NONE	Previous MI in 1991, Cardiac cath 1995		FLU2271199	1						1	Chest pain	FLU3~PARKDALE PHARMACEUTICALS~02289P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0154267	06/15/2000	NY	65.0	65		F	12/01/1999	Pt developed a bad rash and hives all over the body, one week post vax.  She took prednisone to clear it up but was advised by the physician to stop. She continues to experience hives and rash with itching and burning.									U	10/29/1999	11/04/1999	6	UNK	PVT	PVT	NONE	NONE	Spandex, polyester and wool allergies		FLU2211199	1						1	Pruritus; Skin burning sensation; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~02879P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0154268	06/15/2000	MT	43.0	43		F	11/15/1999	Pt experienced injection site soreness amd subcutaneous crepitus.									U	11/15/1999	11/15/1999	0	UNK	PVT	PVT	UNK	NONE	NONE		FLU2331199	1						1	Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~01889P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0154269	06/15/2000	NY	60.0			F	11/28/1999	Pt experienced malaise, pain, tingling in both hands for 12 hours. Pt later, felt myalgia that lasted for two weeks, post vax. After 2 weeks, pain remains in hands and feet.									Y	11/01/1999	11/01/1999	0	Per pt, all blood work normal.	PVT	PVT	UNK	UNK	UNK		FLU2291199	1						1	Malaise; Myalgia; Pain; Paraesthesia	FLU3~PARKDALE PHARMACEUTICALS~~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0154270	06/15/2000	AZ	48.0	48		F	11/11/1999	Pt experienced injection site reaction characterized by redness and heat, 4cm circular area. Resolved after 48 hours.									Y	11/08/1999	11/08/1999	0	NONE	PVT	PVT	NONE	NONE	NONE		FLU2341199	1						1	Injection site erythema; Injection site warmth	FLU3~PARKDALE PHARMACEUTICALS~00399P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0154271	06/15/2000	IN	30.0	30		F	11/04/1999	Pt experienced palpation and dizziness within 15 minutes post vax.  The reaction lasted for 24 hours.									Y	10/28/1999	10/28/1999	0	NONE	OTH	PVT	NONE	Bacterial infection of throat prior to vax.	NONE		FLU2301199	1						1	Dizziness; Palpitations	FLU3~PARKDALE PHARMACEUTICALS~02879P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0154272	06/15/2000	FL	73.0	73		F	11/15/1999	Pt experienced dizziness and vomiting X 2 and vital signs were stable. Pt was given Antivert for dizziness and recovered on 11/11/1999.									Y	11/09/1999	11/09/1999	0	NONE	PVT	OTH	Procardia, Persantine, Inderal, Zocor	NONE	NONE		FLU2381199	1						1	Dizziness; Vomiting	FLU3~PARKDALE PHARMACEUTICALS~~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0154273	06/15/2000	AZ	39.0	39		M	11/11/1999	Pt developed a red spot in area of injection site.									Y	11/08/1999	11/09/1999	1	UNK	OTH	PVT		NONE	NONE		FLU2241199	1						1	Injection site erythema	FLU3~PARKDALE PHARMACEUTICALS~00399P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0154274	06/15/2000	IN				F	11/05/1999	4 hours post vax, pt complained of lower back pain over both kidney areas. 3 hours later, all joints and muscles hurt and it was difficult to breath.  Symptoms gradually became worse. Saw doctor at office and had a fever. Physician diagnosed light case of flu and prescribed Advil and Tylenol. Symptoms lasted for 2 1/2 days.									Y	10/28/1999	10/28/1999	0	UNK	PVT	PVT		UNK	Allergic to aspirin, PCN and sulfa.		FLU2311199	1						1	Arthralgia; Back pain; Dyspnoea; Influenza; Myalgia; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~02879P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0154275	06/15/2000	TN				U	01/19/2000	Pt reported a large reddened area at injection site, 2X3cm, warm and tender to touch, itching and nodule size of a quarter.  Pt recovered.									Y	01/17/2000	01/17/2000	0	NONE	PVT	PVT	NONE	NONE	NONE		FLU2390100	1						1	Feeling hot; Injection site erythema; Injection site nodule; Injection site pain; Pruritus	FLU3~PARKDALE PHARMACEUTICALS~03179P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0154276	06/15/2000	WA	49.0	48		F	02/11/2000	Pt complained of severe pain in right arm that radiated from deltoid up to shoulder and lateral thorax.									Y	12/01/1999	12/27/1999	26	NONE	OTH	OTH	UNK	UNK	UNK		FLU2400100	1						1	Chest pain; Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~02979P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0154278	06/15/2000	AZ	27.0	27		F	11/11/1999	Pt developed red, hard, sore area around injection site, size 4X4cm.									Y	11/08/1999	11/09/1999	1	NONE	PVT	PVT	PCN	NONE	NONE		FLU2231199	1						1	Injection site erythema; Injection site mass; Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~00399P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0154314	06/15/2000	IA				F	12/13/1999	Pt developed a rapid heart beat and fever after receiving an influenza virus and pneumococcal vaccines on the same day.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ7696107DEC1999	1						1	Heart rate increased; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0154315	06/15/2000	ND	18.0			M	01/10/2000	Within days of receiving an injection of Flu Shield, pt developed a hypersensitivity reaction manifested by severe hives and itching.  Pt was treated with unspecified antihistamines and topical preparations and recovered in 7 to 10 days.				Y					Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ9388522DEC1999	1						1	Pruritus; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0154320	06/15/2000	NC				F	10/29/1999	Within 24 hours post vax, pt developed an injection site reaction characterized by induration, redness, warmth and pain.									U		09/23/1999		UNK	PVT	OTH	UNK	NONE	UNK		HQ0750328SEP1999	1						1	Injection site erythema; Injection site mass; Injection site pain; Injection site warmth	FLU3~PFIZER\WYETH~4998223~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0133819	06/20/2000	OR	48.0			M	01/30/2000	12 hrs post vax. Awoke vomiting, diarrhea, spinning or dizzy. After 3 months, pt is still experiencing problems. Saw otolaryngologist.				Y					N					OTH	PVT	NA		NA	~ ()~~~In patient		1						1	Diarrhoea; Dizziness; Vomiting; Diarrhoea; Dizziness; Vomiting	FLU3~PARKDALE PHARMACEUTICALS~40995010~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~40995010~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0133819	06/20/2000	OR	48.0			M	01/30/2000	12 hrs post vax. Awoke vomiting, diarrhea, spinning or dizzy. After 3 months, pt is still experiencing problems. Saw otolaryngologist.				Y					N					OTH	PVT	NA		NA	~ ()~~~In patient		1						2	Diarrhoea; Dizziness; Vomiting; Diarrhoea; Dizziness; Vomiting	FLU3~PARKDALE PHARMACEUTICALS~40995010~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~40995010~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0154212	06/20/2000	OH	9.0			M	05/27/2000	Reported by the pt that he was dx with Guillian Barre Syndrome after receiving vax. Pt experienced parital paralysis, weakness, pain all over the body, lost of voice and shortness of breath. Pt reported he was hospitalized for 7 days.					Y	7			U	10/01/1998	10/01/1998	0		PVT	PVT	NONE	NONE	NONE		FLU24070500	1						2	Dyspnoea; Guillain-Barre syndrome; Lung disorder; Asthenia; Dysphonia; Dyspnoea; Guillain-Barre syndrome; Pain; Paralysis	FLU3~PARKDALE PHARMACEUTICALS~028389P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~02089P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Hospitalisation	Influenza
0154777	06/20/2000	KS	45.0	44		F		Pt experienced redness and hardness approximately 4 1/2 cm that persisted for three days.									Y	10/11/1999	10/12/1999	1	NONE	PUB	PVT		NONE	NONE			1						1	Injection site erythema; Injection site mass	FLU3~CONNAUGHT LABORATORIES~U0163AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154821	06/20/2000	NC				U	10/28/1999	Within 15 minutes post vax pt developed an injection site reaction characterized by 3 - 4 cm area of induration, redness, warmth and pain.  Benadryl 50mg was administered and the pt recovered.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ0822129SEP1999	1						1	Injection site erythema; Injection site mass; Injection site pain; Injection site warmth	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154822	06/20/2000	NY				U	10/28/1999	A physician reported that approximately 40 to 50% of 25 pts experienced an injection site reaction described as either redness or swelling following the receipt of Flu-Shield in September of 1999.									U	09/01/1999	09/01/1999	0	UNK	OTH	OTH	UNK	UNK	UNK		HQ0860529SEP1999	1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4998237~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154824	06/20/2000	NY	9.0			M	02/25/2000	Pt experienced hives (urticaria) that lasted for 4 days.									Y	10/01/1998	10/01/1998	0	UNK	PVT	PVT					FLU24060500	1						1	Urticaria	FLU3~PARKDALE PHARMACEUTICALS~02089P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0154825	06/20/2000	AZ				F	05/27/2000	Pt experienced hot, red wheels around injection site; 4 cm that lasted for 4 days.									Y	01/08/2000	01/08/2000	0	NONE	UNK	UNK	NONE	NONE	NONE		FLU24090500	1						1	Injection site hypersensitivity; Vasodilation procedure	FLU3~PARKDALE PHARMACEUTICALS~00399P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0154826	06/20/2000	AR				F	05/27/2000	Pt reported red, wheel, hot area about 4 cm around the injection site. The reaction lasted for two days									Y	01/08/2000	01/08/2000	0	NONE	PVT	PVT	NONE	NONE	NONE		FLU24100500	1						1	Injection site hypersensitivity; Vasodilation procedure	FLU3~PARKDALE PHARMACEUTICALS~00399P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0154827	06/20/2000	AR				F	05/27/2000	Pt experienced hot, red, wheel around the injection site, 4 cm. The reaction lasted for 2 days.									Y	01/08/2000	01/08/2000	0	NONE	PVT	PVT	NONE	NONE	NONE		FLU24110500	1						1	Injection site hypersensitivity; Vasodilation procedure	FLU3~PARKDALE PHARMACEUTICALS~00399P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0154828	06/20/2000	SC	49.0	49		M	02/24/1999	Two days post vax pt experienced systemic reactions of headache, general malaise, fever, nausea, vomiting and myalgia. Pt also experienced a low grade fever, stiffness, coughing with mucous, hoarseness and headache.									Y	10/12/1998	10/14/1998	2	NONE	PUB	PUB		NONE	allergic bronchitis and sinusitis		U1998006360	1						1	Cough; Dysphonia; Headache; Malaise; Musculoskeletal stiffness; Nausea; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~0980580~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154829	06/20/2000	SC				U	10/15/1998	3 - 5 days post vax pt experienced systemic reactions of headache, general malaise, fever, nausea, vomiting and myalgia.									U	10/09/1998	10/12/1998	3		UNK	UNK					U1998006380	1						1	Headache; Malaise; Myalgia; Nausea; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~0980580~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154830	06/20/2000	GA	37.0	37		F	12/22/1998	One day post vax pt experienced generalized rash, urticaria; which was treated with Benadryl.									Y	10/01/1998	10/02/1998	1		PVT	PVT	NONE	NONE	NONE		U1998006390	1						1	Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154831	06/20/2000	IN				F	11/23/1998	Pt experienced local reaction redness, swelling and general malaise. The pt also experienced headaches. Subsequently the pt recovered.									Y	10/09/1998	10/09/1998	0		PUB	OTH	NONE	NONR			U1998006400	1						1	Headache; Injection site hypersensitivity; Injection site oedema; Malaise	FLU3~CONNAUGHT LABORATORIES~0972850~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154832	06/20/2000	IA	48.0	48		F	10/15/1998	Pt experienced fever, diarrhea, swollen are, swollen throat, huge bright red-hot area of injection, hives and puffy face.				Y					U	10/12/1998				UNK	UNK					U1998006410	1						1	Diarrhoea; Face oedema; Injection site hypersensitivity; Oedema peripheral; Pharyngeal oedema; Pyrexia; Urticaria	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0115280	06/21/2000	NC	45.0	46		F	12/23/1998	Pt experienced hives at the injection site, lightheadedness and shortness of breath. Pt was treated with epinephrine.				Y					Y	10/14/1998	10/14/1998	0		PUB	PVT					U1998006830	1						2	Dizziness; Dyspnoea; Injection site urticaria	FLU3~CONNAUGHT LABORATORIES~0978660~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0115281	06/21/2000	NC	82.0	82		F	10/15/1998	pt recv vax & 10min later c/o itching on lt arm w/a 5cm red circle over lt arm;pt reported feeling a little weak but not SOB;pt BP was 130/90, 140/70 over next 15min;pt c/o itching over rt arm;				Y					Y	10/15/1998	10/15/1998	0	NONE	OTH	PVT		NONE	hypertension, allergic to codeine, sulfa, iron, pain meds;	~ ()~~~In patient		1						1	Asthenia; Condition aggravated; Hypotension; Pruritus; Vasodilatation; Asthenia; Condition aggravated; Hypotension; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0978660~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0978660~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0115281	06/21/2000	NC	82.0	82		F	10/15/1998	pt recv vax & 10min later c/o itching on lt arm w/a 5cm red circle over lt arm;pt reported feeling a little weak but not SOB;pt BP was 130/90, 140/70 over next 15min;pt c/o itching over rt arm;				Y					Y	10/15/1998	10/15/1998	0	NONE	OTH	PVT		NONE	hypertension, allergic to codeine, sulfa, iron, pain meds;	~ ()~~~In patient		1						2	Asthenia; Condition aggravated; Hypotension; Pruritus; Vasodilatation; Asthenia; Condition aggravated; Hypotension; Pruritus; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0978660~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0978660~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0115284	06/21/2000	IA	25.0	25		F	10/16/1998	pt recv vax & w/in min c/o metallic taste in mouth, face became very flushed, resp diff, tongue swelling, tachycardia, epi given transported by ambulance to hosp;				Y					Y	10/14/1998	10/14/1998	0		OTH	PUB	NONE	NONE	hx of asthma uses inhaler PRn	pt exp rxn @ 25yr old w/Td vax;~ ()~~~In patient		1						1	Dysgeusia; Dyspnoea; Tachycardia; Tongue oedema; Vasodilatation; Dysgeusia; Dyspnoea; Tachycardia; Tongue oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975790~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0975790~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0115284	06/21/2000	IA	25.0	25		F	10/16/1998	pt recv vax & w/in min c/o metallic taste in mouth, face became very flushed, resp diff, tongue swelling, tachycardia, epi given transported by ambulance to hosp;				Y					Y	10/14/1998	10/14/1998	0		OTH	PUB	NONE	NONE	hx of asthma uses inhaler PRn	pt exp rxn @ 25yr old w/Td vax;~ ()~~~In patient		1						2	Dysgeusia; Dyspnoea; Tachycardia; Tongue oedema; Vasodilatation; Dysgeusia; Dyspnoea; Tachycardia; Tongue oedema; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0975790~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0975790~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0115300	06/21/2000	NY	2.0	2	.1	F	12/01/1998	One day post vax, pt experienced on giant hive over entire left arm.				Y					Y	10/14/1998	10/15/1998	1	NONE	PVT	PVT	Albuterol		reactive airway disease		U1998006650	1						2	Angioneurotic oedema	FLU3~CONNAUGHT LABORATORIES~0968380~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0115327	06/21/2000	NY	45.0	45		F	12/22/1998	It was reported that a female pt in her 40's received Fluzone SV 98-99 USP on 10/20/98. Reportedly that same day the pt complained of redness, swelling and headache. From additional information received on 11/16/98, it was reported that the pt recovered from this experience. Also reported were the pt's  information, the physician responsible and other medications.									Y	10/20/1998	10/20/1998	0		PVT	PVT	Prevacid, Propulsid, Prempro, Accupril				U1998001717	1						2	Erythema; Headache; Oedema	FLU3~SANOFI PASTEUR~0981800~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0115719	06/21/2000	NY	27.0	27		F	10/27/1998	It was reported that a 27 year old female received Fluzone SV 98-99 USP on 10/25/98. Reportedly that same day the pt experienced a local reaction. Tingling with difficulty grasping on both arms.									U	10/25/1998	10/25/1998	0		OTH	OTH					U199800712	1						2	Injection site reaction; Muscular weakness; Paraesthesia	FLU3~SANOFI PASTEUR~0984530~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0116359	06/21/2000	NC	47.0	47		F	11/09/1998	pt recv vax & exp immed rxn of redness @ inj site;c/o stinging in lt arm, face became flushed;T101.4;c/o heart racing;radial pulse was unable to obtain d/t # of skipped beats;BP on arrival in hosp ER 193/92 w/tachycardia heart;				Y					Y	10/29/1998	10/29/1998	0		OTH	OTH	NONE	NA	NONE	~ ()~~~In patient		1						1	Arrhythmia; Hypertension; Injection site hypersensitivity; Injection site pain; Pain; Pyrexia; Tachycardia; Vasodilatation; Arrhythmia; Hypertension; Injection site hypersensitivity; Injection site pain; Pain; Pyrexia; Tachycardia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0984550~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0984550~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0116359	06/21/2000	NC	47.0	47		F	11/09/1998	pt recv vax & exp immed rxn of redness @ inj site;c/o stinging in lt arm, face became flushed;T101.4;c/o heart racing;radial pulse was unable to obtain d/t # of skipped beats;BP on arrival in hosp ER 193/92 w/tachycardia heart;				Y					Y	10/29/1998	10/29/1998	0		OTH	OTH	NONE	NA	NONE	~ ()~~~In patient		1						2	Arrhythmia; Hypertension; Injection site hypersensitivity; Injection site pain; Pain; Pyrexia; Tachycardia; Vasodilatation; Arrhythmia; Hypertension; Injection site hypersensitivity; Injection site pain; Pain; Pyrexia; Tachycardia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0984550~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0984550~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0116648	06/21/2000	WI	65.0	65		F	12/14/1998	p/vax pt devel cellulitis @ site of pneumonia inj;pt was eval @ ER tx w/IV ATB 7 sent home to complete oral ATB therapy;pt recovered;				Y						10/03/1998	10/03/1998	0	unk	PUB	PVT	unk	unk	unk	NONE~ ()~~~In patient	898351024A	1						2	Cellulitis; Injection site hypersensitivity; Cellulitis; Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~0977180~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~454976~1~~LA~PNEUMO (PNU-IMUNE)~2|FLU3~CONNAUGHT LABORATORIES~0977180~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~PFIZER\WYETH~454976~1~~LA~PNEUMO (PNU-IMUNE)~3	USA	Emergency room visit	Influenza
0116648	06/21/2000	WI	65.0	65		F	12/14/1998	p/vax pt devel cellulitis @ site of pneumonia inj;pt was eval @ ER tx w/IV ATB 7 sent home to complete oral ATB therapy;pt recovered;				Y						10/03/1998	10/03/1998	0	unk	PUB	PVT	unk	unk	unk	NONE~ ()~~~In patient	898351024A	1						3	Cellulitis; Injection site hypersensitivity; Cellulitis; Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~0977180~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~454976~1~~LA~PNEUMO (PNU-IMUNE)~2|FLU3~CONNAUGHT LABORATORIES~0977180~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~PFIZER\WYETH~454976~1~~LA~PNEUMO (PNU-IMUNE)~3	USA	Emergency room visit	Influenza
0116649	06/21/2000	WI	73.0	73		F	11/18/1998	14OCT98 pt recv  & 17OCT noon pt had cramps-stomach, backache;pt went to hosp dx w/MD influenzae;pt was sent home;				Y					U	10/14/1998	10/17/1998	3		PUB	PVT				~ ()~~~In patient		1						1	Abdominal pain; Back pain; Influenza; Abdominal pain; Back pain; Influenza	FLU3~CONNAUGHT LABORATORIES~0981800~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0981800~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0116649	06/21/2000	WI	73.0	73		F	11/18/1998	14OCT98 pt recv  & 17OCT noon pt had cramps-stomach, backache;pt went to hosp dx w/MD influenzae;pt was sent home;				Y					U	10/14/1998	10/17/1998	3		PUB	PVT				~ ()~~~In patient		1						2	Abdominal pain; Back pain; Influenza; Abdominal pain; Back pain; Influenza	FLU3~CONNAUGHT LABORATORIES~0981800~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0981800~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0116650	06/21/2000	WI	43.0	43		F	11/18/1998	1wk p/vax pt had chest & throat tightness;went to hosp ER 25OCT dx was sinus infect & also flu shot rxn;f/u MD appt w/Md on 10NOV;				Y					U	10/17/1998	10/25/1998	8		PUB	PVT						1						1	Chest pain; Laryngospasm; Sinusitis; Chest pain; Laryngospasm; Sinusitis	FLU3~CONNAUGHT LABORATORIES~0981800~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0981800~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0116650	06/21/2000	WI	43.0	43		F	11/18/1998	1wk p/vax pt had chest & throat tightness;went to hosp ER 25OCT dx was sinus infect & also flu shot rxn;f/u MD appt w/Md on 10NOV;				Y					U	10/17/1998	10/25/1998	8		PUB	PVT						1						2	Chest pain; Laryngospasm; Sinusitis; Chest pain; Laryngospasm; Sinusitis	FLU3~CONNAUGHT LABORATORIES~0981800~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0981800~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0116688	06/21/2000	PA				F	12/01/1998	fever 100, ache in joints w/in 4hr;arm red & swollen w/in 12hr;local rash for 3 days;				Y					Y	11/03/1998	11/03/1998	0		PUB	PVT				~ ()~~~In patient		1						2	Arthralgia; Injection site hypersensitivity; Oedema peripheral; Pyrexia; Vasodilatation; Arthralgia; Injection site hypersensitivity; Oedema peripheral; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0984500~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~0984500~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Emergency room visit	Influenza
0116688	06/21/2000	PA				F	12/01/1998	fever 100, ache in joints w/in 4hr;arm red & swollen w/in 12hr;local rash for 3 days;				Y					Y	11/03/1998	11/03/1998	0		PUB	PVT				~ ()~~~In patient		1						3	Arthralgia; Injection site hypersensitivity; Oedema peripheral; Pyrexia; Vasodilatation; Arthralgia; Injection site hypersensitivity; Oedema peripheral; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0984500~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~0984500~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Emergency room visit	Influenza
0116896	06/21/2000	WI	33.0	33		F	11/20/1998	pt exp hives/rash all over body;				Y					U	10/21/1998				PUB	PVT				~ ()~~~In patient		1						1	Rash; Urticaria; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~0981800~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0981800~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0116896	06/21/2000	WI	33.0	33		F	11/20/1998	pt exp hives/rash all over body;				Y					U	10/21/1998				PUB	PVT				~ ()~~~In patient		1						2	Rash; Urticaria; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~0981800~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0981800~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0116903	06/21/2000	WI	0.1	0	.1	F	11/20/1998	Dizzy & diaphoretic 10 min p/ vax,BP 100/60, P 82, 5 min p/ laying down BP126/80, P 82, left clinic w/ no other c/o									Y	10/24/1998	10/24/1998	0		PUB	PVT				~ ()~~~In patient		1						1	Dizziness; Hyperhidrosis; Hypertension; Hypotension; Dizziness; Hyperhidrosis; Hypertension; Hypotension	FLU3~CONNAUGHT LABORATORIES~0981800~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0981800~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0116903	06/21/2000	WI	0.1	0	.1	F	11/20/1998	Dizzy & diaphoretic 10 min p/ vax,BP 100/60, P 82, 5 min p/ laying down BP126/80, P 82, left clinic w/ no other c/o									Y	10/24/1998	10/24/1998	0		PUB	PVT				~ ()~~~In patient		1						2	Dizziness; Hyperhidrosis; Hypertension; Hypotension; Dizziness; Hyperhidrosis; Hypertension; Hypotension	FLU3~CONNAUGHT LABORATORIES~0981800~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0981800~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0116904	06/21/2000	WI	64.0	64		F	11/20/1998	pt recv vax 29OCT98 & 31OCT98 pt devel itching around neck area, by monday 2NOV98 red & itchy;no breathing problems;no sneezing, watery eyes;pt took DPH;has had rxn in past to sulfa;									U	10/29/1998	10/31/1998	2		PUB	PVT			reaction in past to sulfa describes same rxn	~ ()~~~In patient		1						1	Pruritus; Rash; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~0981800~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0981800~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0116904	06/21/2000	WI	64.0	64		F	11/20/1998	pt recv vax 29OCT98 & 31OCT98 pt devel itching around neck area, by monday 2NOV98 red & itchy;no breathing problems;no sneezing, watery eyes;pt took DPH;has had rxn in past to sulfa;									U	10/29/1998	10/31/1998	2		PUB	PVT			reaction in past to sulfa describes same rxn	~ ()~~~In patient		1						2	Pruritus; Rash; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~0981800~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0981800~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0116905	06/21/2000	WI	48.0	48		F	11/20/1998	pt started last noc w/chills, aches, phlegm build up causing vomiting;pt stated had a similar rxn last year from flu shot;									Y	10/27/1998	10/27/1998	0		PUB	PVT				pt had similar rxn last year from flu shot~ ()~~~In patient		1						1	Chills; Myalgia; Salivary hypersecretion; Chills; Myalgia; Salivary hypersecretion	FLU3~CONNAUGHT LABORATORIES~0981800~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0981800~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0116905	06/21/2000	WI	48.0	48		F	11/20/1998	pt started last noc w/chills, aches, phlegm build up causing vomiting;pt stated had a similar rxn last year from flu shot;									Y	10/27/1998	10/27/1998	0		PUB	PVT				pt had similar rxn last year from flu shot~ ()~~~In patient		1						2	Chills; Myalgia; Salivary hypersecretion; Chills; Myalgia; Salivary hypersecretion	FLU3~CONNAUGHT LABORATORIES~0981800~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0981800~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0117054	06/21/2000	IL	75.0	75		F	11/27/1998	Pt recv vax on 11/12/98; on 11/14/98 pt exp dizziness, vomiting, blurred vision, chills & fever, shakes									Y	11/12/1998	11/14/1998	2	NONE	PVT	PVT	Indaral, Lotensen, HCTZ, Levorxyl	NONE	NONE	UNK~ ()~~~In patient		1						1	Amblyopia; Dizziness; Pyrexia; Tremor; Vomiting; Amblyopia; Dizziness; Pyrexia; Tremor; Vomiting	FLU3~CONNAUGHT LABORATORIES~0988300~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0988300~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0117054	06/21/2000	IL	75.0	75		F	11/27/1998	Pt recv vax on 11/12/98; on 11/14/98 pt exp dizziness, vomiting, blurred vision, chills & fever, shakes									Y	11/12/1998	11/14/1998	2	NONE	PVT	PVT	Indaral, Lotensen, HCTZ, Levorxyl	NONE	NONE	UNK~ ()~~~In patient		1						2	Amblyopia; Dizziness; Pyrexia; Tremor; Vomiting; Amblyopia; Dizziness; Pyrexia; Tremor; Vomiting	FLU3~CONNAUGHT LABORATORIES~0988300~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0988300~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0117118	06/21/2000	WA	42.0	42		F	12/01/1998	rt sided facial weakness (?bell' s palsy): included inability to move forehead, close or blink rt eye, move mouth muscles, skin sagging  @ jaw;sx on rt side of face;				Y					N	10/12/1998	11/10/1998	29	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						1	Facial palsy; Hypokinesia; Myasthenic syndrome; Facial palsy; Hypokinesia; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~0981800~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0981800~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0117118	06/21/2000	WA	42.0	42		F	12/01/1998	rt sided facial weakness (?bell' s palsy): included inability to move forehead, close or blink rt eye, move mouth muscles, skin sagging  @ jaw;sx on rt side of face;				Y					N	10/12/1998	11/10/1998	29	NONE	PVT	PVT	NONE	NONE	NONE	NONE~ ()~~~In patient		1						2	Facial palsy; Hypokinesia; Myasthenic syndrome; Facial palsy; Hypokinesia; Myasthenic syndrome	FLU3~CONNAUGHT LABORATORIES~0981800~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0981800~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0117323	06/21/2000	MD	39.0	39		F	11/19/1998	pt recv vax 30OCT98 & devel Bells Palsy lt 8NOV98;				Y					Y	10/30/1998	11/08/1998	9		PUB	PUB	birth control pills	NONE	NONE	NONE~ ()~~~In patient	MD98019	1						1	Facial palsy; Facial palsy	FLU3~CONNAUGHT LABORATORIES~0981840~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0981840~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0117323	06/21/2000	MD	39.0	39		F	11/19/1998	pt recv vax 30OCT98 & devel Bells Palsy lt 8NOV98;				Y					Y	10/30/1998	11/08/1998	9		PUB	PUB	birth control pills	NONE	NONE	NONE~ ()~~~In patient	MD98019	1						2	Facial palsy; Facial palsy	FLU3~CONNAUGHT LABORATORIES~0981840~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0981840~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0117616	06/21/2000	CO	47.0	46		F	12/15/1998	pt recv vax 16NOV98 & pt reported fine rash that started on trunk & was moved to different areas of body starting 15min p/inj;									Y	11/16/1998	11/16/1998	0	NONE	OTH	OTH	Prilosec synthroid;Ferrous sulfate;Reglan;Imipramine, mult vit;insulin;	NONE	NONE	NONE~ ()~~~In patient		1						1	Rash; Rash	FLU3~CONNAUGHT LABORATORIES~0988290~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0988290~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0117616	06/21/2000	CO	47.0	46		F	12/15/1998	pt recv vax 16NOV98 & pt reported fine rash that started on trunk & was moved to different areas of body starting 15min p/inj;									Y	11/16/1998	11/16/1998	0	NONE	OTH	OTH	Prilosec synthroid;Ferrous sulfate;Reglan;Imipramine, mult vit;insulin;	NONE	NONE	NONE~ ()~~~In patient		1						2	Rash; Rash	FLU3~CONNAUGHT LABORATORIES~0988290~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0988290~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0117621	06/21/2000	CA	46.0	46		M	12/22/1998	It was reported that a 46 year old male received Fluzone (1998-1999) on 10/28/1998. Reportedly, 11 hours, post vax, the pt experienced vomiting, muscle spasms, shortness of breath and chills. Pt was reportedly seen at urgent care clinic. From additional information received, on 11/16/1998, it was reported that the pt recovered from this experienced. Also, reported were the pt's information and the responsible physician information.				Y					Y	10/28/1998	10/28/1998	0		OTH	PVT					U1998007350	1						2	Chills; Dyspnoea; Muscle spasms; Vomiting	FLU3~CONNAUGHT LABORATORIES~0978710~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0118021	06/21/2000	CT	60.0	60		F		Pt recv vax on 10/12/98; on 10/16/98 pt exp burning/ pain vax site, numb LA elbow - fingers w/ weakness of fingers x 1 mon; left clavicle pain & left upper shoulder weakness									N	10/12/1998	10/16/1998	4	NONE	PVT	PVT	UNK	NONE	Myasthenia	UNK~ ()~~~In patient		1						1	Condition aggravated; Injection site pain; Neck pain; Paraesthesia; Condition aggravated; Injection site pain; Neck pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0968410~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0968410~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0118021	06/21/2000	CT	60.0	60		F		Pt recv vax on 10/12/98; on 10/16/98 pt exp burning/ pain vax site, numb LA elbow - fingers w/ weakness of fingers x 1 mon; left clavicle pain & left upper shoulder weakness									N	10/12/1998	10/16/1998	4	NONE	PVT	PVT	UNK	NONE	Myasthenia	UNK~ ()~~~In patient		1						2	Condition aggravated; Injection site pain; Neck pain; Paraesthesia; Condition aggravated; Injection site pain; Neck pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0968410~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0968410~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0118282	06/21/2000	VT	48.0	48		M	06/26/2001	Reportedly the pt called a month after injection stating he has been sick with diarrhea, nausea, and headache since injection, had not seen a physician. States there was few others at office who were sick. From follow-up correspondence recieved on 04/04/2001, it was reported, No further info at this time. From mailed follow-up correspondence received on 06/06/2001, it was stated: I did not follow-up with this pt. Had tried initially in 1998 but was unable to reach him. This case is closed.									U	11/05/1998			UNK	OTH	PVT		NONE	NONE		U1999000420	1						2	Diarrhoea; Headache; Nausea	FLU3~CONNAUGHT LABORATORIES~0984550~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0120153	06/21/2000	TX	38.0	38		F	03/02/1999	post flu vax pt presents w/an indentation to lt deltoid area, measuring approx 2cm diameter & 2cm deep;									U	10/21/1998	10/24/1998	3	NONE	OTH	PVT	Depo Provera	NONE	NONE	NONE~ ()~~~In patient		1						1	Injection site atrophy; Injection site atrophy	FLU3~CONNAUGHT LABORATORIES~0969600~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0969600~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0120153	06/21/2000	TX	38.0	38		F	03/02/1999	post flu vax pt presents w/an indentation to lt deltoid area, measuring approx 2cm diameter & 2cm deep;									U	10/21/1998	10/24/1998	3	NONE	OTH	PVT	Depo Provera	NONE	NONE	NONE~ ()~~~In patient		1						2	Injection site atrophy; Injection site atrophy	FLU3~CONNAUGHT LABORATORIES~0969600~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0969600~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0128024	06/21/2000	NJ	61.0	61		F	12/31/1998	Two days post vax pt experienced a localized reaction of redness, swelling and pain at the injection site.									U	10/15/1998	10/17/1998	2		UNK	UNK					U1998006610	1						2	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0975850~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~448175~UNK~IM~~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0154862	06/21/2000	PA	51.0	51		M	10/15/1998	Two days post vax, pt experienced redness and tenderness.  Red area approximately 6X6 cm at injection site. The next day the pt no longer had any pain. Afebrile.									Y	10/05/1998	10/07/1998	2		OTH	PVT	Lotensin, Lescol	allergy	PCN, Merthiclate, Adhesives, Grass allergies.		U1998006430	1						1	Injection site erythema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~097390~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154863	06/21/2000	SC	34.0	34		F	02/24/1999	Pt experienced systemic reactions of headache, general malaise, fever, nausea, vomiting and myalgia. Follow-up information received on 2/23/98, reported that the headaches, nausea and upset stomach lasted about 48 hours and the pt recovered from this experience.									Y	10/09/1998			NONE	PUB	PUB	NONE	NONE	Amoxicillin, Septra, PCN		U1998-006370	1						1	Headache; Malaise; Myalgia; Nausea; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~0960580~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154864	06/21/2000	CA	39.0	39		F	12/22/1998	One day post vax, pt experienced a large red area over injection site 11 X 7 cm. From additional information received on 11/16/98, the pt recovered from this experience.									Y	10/03/1998	10/14/1998	11		PUB	UNK	NONE		NONE		U1998006440	1						1	Injection site erythema	FLU3~CONNAUGHT LABORATORIES~0980580~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154868	06/21/2000	NC	28.0			F	12/22/1998	One day post vax pt complained of hives, redness and warmth 2 X 1.5 inches at site of injection.									Y	10/13/1998	10/14/1998	1	NONE	UNK	UNK		NONE	NONE		U1998006470	1						1	Feeling hot; Injection site hypersensitivity; Urticaria	FLU3~CONNAUGHT LABORATORIES~0977210~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154869	06/21/2000	NC	41.0			F	12/22/1998	One day post vax, pt complained of hives, redness and warmth 2 X 1.5 inches at injection site.									Y	10/13/1998	10/14/1998	1	NONE	UNK	UNK		NONE	NONE		U1998006480	1						1	Feeling hot; Injection site hypersensitivity; Urticaria	FLU3~CONNAUGHT LABORATORIES~0977210~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154870	06/21/2000	WI	39.0	39		F	12/23/1998	Pt experienced a large baseball sized redness with some soreness at injection site. Redness and swelling took 2 - 3 days to resolve.									Y	10/14/1998				PUB	PVT	birth control pills	NONE			U1998006510	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0969600~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154871	06/21/2000	NH	47.0	47		F	12/04/1998	Several hours post vax, pt experienced hives and blotches resembling black and blue marks. From additional information received on 12/4/98, it was reported, tightening of throat, was seen by physician at ER and states received a prescription for prednisone but did not fill it. Client took 2 Benadryl and gradually improved within 3-4 days. It was reported that the pt recovered from this experience.				Y					Y	10/16/1998	10/16/1998	0		OTH	UNK	Zoloft	NONE	PCN, Sulfur allergies		U1998006530	1						1	Ecchymosis; Throat tightness	FLU3~CONNAUGHT LABORATORIES~0980540~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0154872	06/21/2000	SC				U	10/09/1998	Pt complained of a 3 inch hard area that was warm to the touch and achiness at injection site.									U					UNK	UNK					U1998006540	1						1	Feeling hot; Injection site mass; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0971890~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154873	06/21/2000	SC				U	10/19/1998	Pt complained of a 3 inch hard area, that was warm to the touch and achiness at injection site.									U					UNK	UNK					U1998006550	1						1	Injection site mass; Injection site pain; Injection site warmth	FLU3~CONNAUGHT LABORATORIES~0971890~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154874	06/21/2000	SC				U	10/19/1998	Pt complained of a 3 inch hard area, that was warm to the touch and achiness at the injection site.									U					UNK	UNK					U1998006560	1						1	Injection site mass; Injection site pain; Injection site warmth	FLU3~CONNAUGHT LABORATORIES~0971890~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154875	06/21/2000	SC				U	10/19/1998	Pt complained of a 3 inch hard area, that was warm to the touch and achiness at the injection site.									U					UNK	UNK					U1998006570	1						1	Injection site mass; Injection site pain; Injection site warmth	FLU3~CONNAUGHT LABORATORIES~0971890~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154876	06/21/2000	SC				U	10/19/1998	Pt complained of a 3 inch hard area, that was warm to the touch and achiness at the injection site.									U					UNK	UNK					U1998006580	1						1	Injection site mass; Injection site pain; Injection site warmth	FLU3~CONNAUGHT LABORATORIES~0971890~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154877	06/21/2000	SC				U	10/19/1998	Pt complained of a 3 inch hard area, that was warm to the touch and achiness at the injection site.									U					UNK	UNK					U1998006590	1						1	Injection site mass; Injection site pain; Injection site warmth	FLU3~CONNAUGHT LABORATORIES~0971890~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154878	06/21/2000	CA	39.0	39		F	11/13/1998	One day post vax, pt complained of swollen glands to neck, axilla and groin. Pt also complained of malaise and headache.									Y	10/15/1998	10/16/1998	1		PVT	PVT	Dapakote, Neurontin	NONE	Seizure disorder		U1998006600	1						1	Headache; Lymphadenopathy; Malaise	FLU3~CONNAUGHT LABORATORIES~0983300~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154880	06/21/2000	OH	87.0	87		F	12/22/1998	One day post vas, pt experienced redness, edema and warmth at and below site approximately 6 inches.									Y	10/09/1998	10/10/1998	1		PVT	PVT	Catapres, Slow K, Lasix	NONE	NONE		U1998006630	1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~CONNAUGHT LABORATORIES~0980580~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154881	06/21/2000	OH	43.0	43		F	12/22/1998	One day post vax, pt experienced redness, warmth and edema at injection site.									Y	10/12/1998	10/13/1998	1		PVT	UNK	Synthroid	NONE	NONE		U1998006640	1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~CONNAUGHT LABORATORIES~0580580~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154883	06/21/2000	FL	64.0	64		F	12/31/1998	Pt experienced red eyes with drainage. Pt also experienced a raw throat and sensation to cough to clear it.				Y					Y	10/16/1998	10/16/1998	0		PUB	PUB					U1998006790	1						1	Eye discharge; Ocular hyperaemia; Pharyngitis	FLU3~CONNAUGHT LABORATORIES~0984610~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0154884	06/21/2000	FL	56.0	56		F	12/31/1998	Pt experienced red eyes with drainage.									Y	10/16/1998	10/16/1998	0		PUB	PVT					U1998006800	1						1	Eye discharge; Ocular hyperaemia	FLU3~CONNAUGHT LABORATORIES~0984610~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154885	06/21/2000	FL				U	10/21/1998	Pt experienced red eyes with drainage.									U					UNK	UNK					U1998006810	1						1	Eye discharge; Ocular hyperaemia	FLU3~CONNAUGHT LABORATORIES~0984610~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154886	06/21/2000	FL				U	10/21/1998	Pt experienced red eyes with drainage.									U					UNK	UNK					U1998006820	1						1	Eye discharge; Ocular hyperaemia	FLU3~CONNAUGHT LABORATORIES~0984610~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154888	06/21/2000	NC	54.0	54		F	11/23/1998	It was reported that a 54 year female received Fluzone SV 98-99 USP vaccine on 10/16/1998. Reportedly sometime after the vaccination the pt experienced a large red area at the site of injection. The pt also experienced a 3-cm lump and pain at the injection site left deltoid to elbow.									U	10/16/1998				PVT	PVT					U199800685	1						1	Injection site mass; Pain	FLU3~SANOFI PASTEUR~0975770~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154889	06/21/2000	OH	80.0	79		F	11/17/1998	It was reported that a 79 year old female received Fluzone SV 98-99 USP vaccine on 10/19/1998. Reportedly on 10/22/98 the pt experienced bilateral leg and arm weakness.									U	10/19/1998	10/21/1998	2		OTH	OTH			diabetic, cardiac		U199800695	1						1	Hemiparesis; Muscular weakness	FLU3~SANOFI PASTEUR~0965770~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154890	06/21/2000	MO	55.0	55		F	10/23/1998	It was reported that  a 55 year old female received Fluzone SV 98-99 USP on 10/14/98. Reportedly the evening after the injection the pt broke out in  hives on trunk of body now all over all of body. Has been seen by MD and in ER . Reportedly the pt still has hives.				Y					N	10/14/1998	10/14/1998	0		OTH	OTH					U199800696	1						1	Urticaria	FLU3~SANOFI PASTEUR~0981820~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0154891	06/21/2000	GA				F	10/23/1998	It was reported that a female received Fluzone SV 98-99 USP vaccine on 10/11/98. Reportedly, the pt bled profusely after the injection. Reportedly the next day the pt woke up with the flu.				Y					U	10/14/1998	10/15/1998	1		UNK	UNK					U199800697	1						1	Bleeding time prolonged; Influenza	FLU3~SANOFI PASTEUR~981810~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0154892	06/21/2000	MA	69.0	68		F	12/23/1998	It was reported that a 68 year old female received Fluzone SV 98-99 USP, on 10/22/98.Reportedly after tha vaccination, the pt experienced scratchy throat, chills, HA, and watery eyes. 3 hours later the pt experienced orbital swelling, joint pain, muscle pain, and fatigue. From additional information received on 11/23/98 It was reported that the pt also c/o upper lip swelling. Reportedly the pt recovered from this experience. reviewed and no additional inofmarion available at this time.									Y	10/22/1998	10/22/1998	0		UNK	UNK					U19800700	1						1	Arthralgia; Chills; Dry throat; Face oedema; Fatigue; Headache; Lacrimation increased; Myalgia; Oedema; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~0984530~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154893	06/21/2000	PA	40.0	40		F	10/26/1998	It was reported that a 40 year old female received Fluzone SV 98-99 USP on 10/19/98. Reportedly somtime after the vaccination the pt experienced redness and warmth at the site.									U	10/19/1998				UNK	UNK					U199800701	1						1	Erythema; Injection site warmth	FLU3~SANOFI PASTEUR~0972840~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154894	06/21/2000	AL	25.0	24		F	12/23/1998	It was reported that a 24 year old female received Fluzone SV 98-99 USP on 10/20/1998. Reportedly, that same day the pt experienced a rash on the right side of her face extending to neck. From additional information received on 11/20/98, it was reproted that the pt recovered from this experience.				Y					Y	10/20/1998	10/20/1998	0		OTH	UNK					U199800705	1						1	Rash	FLU3~SANOFI PASTEUR~0975780~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0154895	06/21/2000	TX				M	11/23/1998	It was reported that a male in his 50's received Fluzone SV 98-99 USP on 10/23/98. Reportedly later that day the pt complained of sleeplessness. From additional information received on 11/20/98 it was reported that he was unable to fall asleep until 2:00 am. Felt like he had too much energy. Reportedly the pt recovered from this experience.									Y	10/23/1998	10/23/1998	0		OTH	OTH					U199800709	1						1	Insomnia	FLU3~SANOFI PASTEUR~0985920~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154896	06/21/2000	CA				F	10/27/1998	It was reported that a female received Fluzone SV 98-99 USP on 10/23/1998. Reportedly on 10/24/1998 the pt complained of redness, hard knot 2x3 and red line shooting out from injection site. The pt also complained of metallic taste in mouth and throat swelling.									U	10/23/1998	10/24/1998	1		UNK	UNK					U199800710	1						1	Cellulitis; Dysgeusia; Injection site erythema; Injection site mass; Pharyngeal oedema; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~0984620~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154897	06/21/2000	VA	47.0	47		F	12/01/1998	It was reported that a female received Fluzone SV 98-99 USP on 10/20/1998. Reportedly on 10/20/1998 the pt experienced fever, swollen eyes, chills, and headache. From additional information received on 11/30/98, it was reported that the reaction started within 48 hours of shot on 10/22/98, reported on 10/26/98. Reportedly the pt recovered from this experience.									Y	10/20/1998	10/22/1998	2		PVT	PVT					U199800711	1						1	Chills; Eyelid oedema; Headache; Pyrexia	FLU3~SANOFI PASTEUR~0985870~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154900	06/21/2000	MO	66.0	65		F	12/22/1998	It was reported that a 63 year old female received Fluzone SV 98-99 USP  on 09/29/98. Reportedly sometime after the vaccination, the pt experienced an aching, swollen, red arm. From additional information received on 11/16/98 it was reported that the pt recovered from this experience.									Y	09/29/1998				OTH	OTH					U199800718	1						1	Erythema; Injection site oedema; Pain	FLU3~SANOFI PASTEUR~0981790~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154901	06/21/2000	MO	59.0			F	12/22/1998	It was reported that a 59 year old female received Fluzone SV 98-99 USP on Sep 29.1998. Reportedly sometime after the vaccination the pt experienced a fever and a swollen, red arm. From additional information received on Nov 16, 1998 it was reported that the pt also experienced chills after receiving the vaccination.									U	09/29/1998				UNK	UNK		NONE	Mitral Valve Prolapse		U199800719	1						1	Chills; Injection site erythema; Injection site oedema; Pyrexia	FLU3~SANOFI PASTEUR~0981790~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154902	06/21/2000	MO	59.0	59		F	12/22/1998	It was reported that a 59 year old female received Fluzone SV 98-99 USP on Sep 29, 1998. Reportedly sometime after the vaccination the pt experienced an aching, swollen, red arm. From additional information received on Nov 16, 1998 it was reported the pt recovered from this experience.									Y	09/29/1998				PVT	UNK		NONE	Mitral Valve Prolapse		U199800720	1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~0981790~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154903	06/21/2000	MO	34.0	34		F	12/22/1998	It was reported that a 34 year old female received Fluzone SV 98-99 USP on 09/29/1998. Reportedly sometime after the vaccination the pt experienced a fever of 100-101F and a swollen, red arm. From additional information received on 11/16/1998 it was reported that the pt recovered from this experience.									Y	09/29/1998	09/29/1998	0		PVT	PVT					U199800721	1						1	Erythema; Injection site erythema; Injection site oedema; Oedema peripheral; Pyrexia	FLU3~SANOFI PASTEUR~0981790~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154904	06/21/2000	FL	40.0	40		F	10/28/1998	It was reported that a 40 year old female received Fluzone SV 98-99 USP vaccine on 10/27/1998. Reportedly within 4 hours the pt stated that she could not move her left arm, the pt also reportedly experienced pain and soreness. Pt not evaluated by a physician.									U	10/27/1998	10/27/1998	0		UNK	UNK					U199800722	1						1	Hypokinesia; Injection site pain	FLU3~SANOFI PASTEUR~0985520~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154905	06/21/2000	KY	46.0	45		M	12/23/1998	It was reported that a 45 year old male received Fluzone SV 98-99 USP on 10/15/1998. Reportedly 6 hours after getting injection the pt developed shaking chill lasting off and on for 12 days. Reportedly the pt was seen by a physician. From additional information received on 11/23/1998 it was reported that the pt recovered from this experience.				Y					Y	10/15/1998	10/15/1998	0	Chest X ray- normal, Urinalysis- normal, CBC- normal, TSH- normal.	PUB	OTH					U199800723	1						1	Chills; Tremor	FLU3~SANOFI PASTEUR~0971880~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0154906	06/21/2000	PA	30.0	29		M	11/13/1998	It was reported that a 29 year old male received Fluzone SV 98-99 USP on 10/12/1998. Reportedly 12-13 hours after receiving the vaccine the pt developed shaking chills, myalgia, and a fever of 103 F. No hives, wheezing, or dysplasia. Reportedly the pt recovered from this experience. From additional information received on 11/13/98, it was reported reviewed, no additional information at this time, MD 11/10/1998				Y					Y	10/12/1998	10/13/1998	1	CBC-WNL: CxR- Clear Blood Cultures x2 negative	OTH	OTH					U199800724	1						1	Chills; Myalgia; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~9878720~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0154907	06/21/2000	CA	51.0	50		F	12/22/1998	It was reported that a 50 year old female received Fluzone SV 98-99 USP vaccine on 10/22/1998. Reportedly on 10/24/1998 the pt developed distal vein thrombosis out left arm. Reportedly the pt recovered from this experience. From additional information received on 11/16/1998 it was reported that the date of the adverse reaction was 10/23/98 at 11:00 PM not 10/24/98 at 6:00am as previously reported.				Y					Y	10/22/1998	10/23/1998	1		PVT	PVT			PCN, sulfa allergies.		U199800726	1						1	Venous thrombosis	FLU3~SANOFI PASTEUR~0977170~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0154908	06/21/2000	WI				F	10/30/1998	It was reported that a female pt received Fluzone SV 98-99 USP vaccine on 10/28/1998. Reportedly sometime after the vaccination the pt experienced swollen sore arm and itching.									U	10/28/1998				OTH	OTH					U199800727	1						1	Oedema; Pruritus	FLU3~SANOFI PASTEUR~0984630~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154909	06/21/2000	AK	31.0	31		M	12/23/1998	It was reported that a 31 year old male received Fluzone SV 98-99 USP on 10/26/1998. Reportedly sometime after the vaccination the pt experienced  swollen arm, erythema, swollen lymph nodes left arm site of injection' From additional information received on 11/23/1998 it was reported that the pt recovered from this experinece.									Y	10/26/1998				PVT	PVT					U199800729	1						1	Injection site erythema; Injection site oedema; Lymphoedema; Oedema peripheral	FLU3~SANOFI PASTEUR~097398~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154968	06/21/2000	SD	29.0	29		F	12/07/1999	Two minutes post vax pt developed an anaphylactic reaction with airway blockage and swelling. Pt was given 3 doses of epinephrine and taken to ER. Pt was placed on a cardiac monitor and received sustained release epinephrine. Pt recovered one day later and was discharged. Pt experienced a similar event following receipt of Depo Provera.				Y	Y	1			Y	10/01/1998	10/01/1998	0	UNK	PVT	OTH	Nordette-21	NONE	Hypersensitivity to Depo-Provera		HQ1902111OCT1999	1						1	Anaphylactic reaction; Pharyngeal oedema	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0154969	06/21/2000	CA				U		UNK									Y				UNK	OTH	OTH	UNK	UNK	UNK		899112054A	1						1	Unevaluable event	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0154970	06/21/2000	IL	54.0			M	01/20/2000	Pt developed flu like symptoms characterized by muscle weakness, scratchy sore throat, slight fever and green mucus. Pt recovered.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ0634020JAN2000	1						1	Influenza like illness; Muscular weakness; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154971	06/21/2000	TN				F	10/20/1999	Pt developed a vaginal yeast infection and itching on the soles of her feet.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ1690107OCT1999	1						1	Pruritus; Vaginal candidiasis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154972	06/21/2000	RI	42.0	42		M	01/06/2000	Within hours of vaccination, pt developed mild itching over his entire body, severe scalp itching and headache. Pt recovered after approximately 2 weeks.									Y	12/02/1998	12/02/1998	0	UNK	PVT	OTH	Pepcid; Testosterone; Valium	NONE	Haemochromatosis; Hypersensitivity NOS; Testicular failure NEC; allergy to sulfa		HQ4434203NOV1999	1						1	Headache; Pruritus	FLU3~PFIZER\WYETH~4988232~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154973	06/21/2000	MA	41.0			F	12/29/1999	Pt developed an injection site reaction characterized by a very large red, raised area measuring 4 inches, which resolved after 10 days.									Y	10/01/1998	10/01/1998	0	UNK	OTH	OTH	UNK	UNK	UNK		HQ5390211NOV1999	1						1	Injection site swelling; Rash erythematous	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0154974	06/21/2000	MI				F	11/30/1999	Pt developed injection site swelling extending to her forearm. Pt was treated with Benadryl.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ6296122NOV1999	1						1	Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155091	06/21/2000	CA	0.2	0	.1	M	02/18/2000	On 5/29/1999, within 2 days, post vax, the infant developed vomiting and prolonged diarrhea. The pt sought medical attention and was dx'd with gastroenteritis. Subsequently, the pt recovered from gastroenteritis. No further information is available.				Y					Y	05/27/1999	05/29/1999	2	Stool analysis-5/29/99-neg for ovea and parasites; stool culture-neg	PVT	PVT			UNK		WAES99121980	1						1	Diarrhoea; Gastroenteritis; Vomiting; Diarrhoea; Vomiting; Diarrhoea; Vomiting	DTAP~CONNAUGHT LABORATORIES~~1~IM~~DTAP (TRIPEDIA)~1|HEP~SMITHKLINE BEECHAM~~2~IM~~HEP B (ENGERIX-B)~1|HIBV~MERCK & CO. INC.~1204B~1~IM~~HIB (PEDVAXHIB)~1|IPV~PASTEUR MERIEUX INST.~~1~SC~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|RV~PFIZER\WYETH~~1~PO~MO~ROTAVIRUS (ROTASHIELD)~1|DTAP~CONNAUGHT LABORATORIES~6F81445~1~IM~~DTAP (TRIPEDIA)~2|FLU3~PFIZER\WYETH~4988139~1~PO~MO~INFLUENZA (SEASONAL) (FLUSHIELD)~2|HEP~SMITHKLINE BEECHAM~2919A2~2~IM~~HEP B (ENGERIX-B)~2|HIBV~MERCK & CO. INC.~1204E~1~IM~~HIB (PEDVAXHIB)~2|IPV~CONNAUGHT LTD.~M0212~1~SC~~POLIO VIRUS, INACT. (POLIOVAX)~2|DTAP~PFIZER\WYETH~~UNK~IM~~DTAP (ACEL-IMUNE)~3|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~3|HIBV~PFIZER\WYETH~~UNK~IM~~HIB (HIBTITER)~3|IPV~PFIZER\WYETH~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~3|RV~PFIZER\WYETH~~1~PO~MO~ROTAVIRUS (ROTASHIELD)~3	USA	Emergency room visit	Influenza
0155093	06/21/2000	NJ	27.0	27		F	12/23/1998	Sometime after the vaccination, the pt experienced a red area around injection site. Reportedly the pt was seen by physician. From additional information received on 11/17/1998, it was reported that the pt recovered from this experience.				Y					Y	10/27/1998				PVT	PVT		NONE	allergy to Cedax		U1598007340	1						1	Injection site erythema	FLU3~CONNAUGHT LABORATORIES~0975770~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0155096	06/21/2000	OH	49.0	49		F	12/23/1998	One day post vax, 11/20/98, the pt experienced redness, warmth and swelling at the site of injection. Reportedly the pt recovered from this experience. From additional information received on 11/16/98, it was reported Reviewed, no additional information at this time.									Y	10/19/1998	10/20/1998	1		PVT	PVT		abdominal pain			U1998007370	1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~CONNAUGHT LABORATORIES~0980580~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155097	06/21/2000	NC	40.0	40		F	11/02/1998	The pt experienced generalized hives covering the body beginning approximately 1 hour post vax with itching and redness. The pt reportedly took over the counter Benadryl, the redness was partially relieved. The pt began to break out again this time in less than 2 hours; redness covered the arms, back, face, neck and legs. Reportedly the pt was sent to their PMD. Atarax, and a topical cream was prescribed. Reportedly the pt recovered from this experience. Follow-up #1 28-Jul-2002: During internal review of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (added rash).				Y					Y	10/29/1998	10/29/1998	0		OTH	OTH					U1998007380	1						1	Erythema; Pruritus; Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~0984550~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0155100	06/21/2000	WV	50.0	50		M	11/02/1998	It was reported that this 50-year-old male received vax on 10/23/98. That same day, the pt complained of fever, achiness and chills.									U	10/23/1998	10/23/1998	0		UNK	UNK					U1998007510	1						1	Chills; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~C981790~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155102	06/21/2000	FL	39.0	39		F	07/22/2002	One day post vax, this pt experienced dizziness, feeling of passing out, nausea and tingling of tongue, hands and feet. The pt reportedly has not yet recovered from this experience, still having symptoms. From additional information received on 11/24/98, it was reported that the pt's symptoms resolved on 10/20/98 and that he had a full neurological exam - dizziness not neuro in nature and pressure inner ears wnl, also not cardiac in nature.  Physician felt that it was flu shot reaction, no dizziness/vertigo in past 4 days. Follow up #1 06/28/02: During internal review of all files, it was deemed necessary to amend the report by updating the adverse event coding (added cardiovascular disorder and syncope)				Y					Y	10/21/1998	10/22/1998	1	all ER Labs work:WNL, CBC, SMA, and CT Scan	OTH	PVT	Relafen, Albuterol, Flonase	NONE	allergy to Compazine, history of asthma		U1998007530	1						1	Cardiovascular disorder; Dizziness; Nausea; Paraesthesia; Syncope	FLU3~CONNAUGHT LABORATORIES~0983290~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0155103	06/21/2000	FL	36.0	36		F	11/23/1998	One day post vax, this pt experienced a low-grade fever and extremely sore arm and neck. Three days post vax, the pt began having cold like symptoms (runny nose, congestion, fatigue). From additional information received on 11/24/98, it was reported that the pt recovered from this experience.									Y	10/28/1998	10/29/1998	1		OTH	PVT	NONE	NONE	allergy to PCN		U1998007540	1						1	Fatigue; Nasal congestion; Neck pain; Pain; Pharyngitis; Pyrexia; Rhinitis; Rhinorrhoea	FLU3~CONNAUGHT LABORATORIES~0973920~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155105	06/21/2000	PA	1.5			U	11/04/1998	This child received vax and the following day the pt experienced a fever of 101 F and vomiting.									U	10/23/1998	10/24/1998	1		UNK	UNK					U1998007580	1						1	Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~0977170~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155107	06/21/2000	IL	40.0	42		F	08/28/2002	(This Report is the case oif Reference duplication of this case is U1998-00913). It was reported that a 40 year female received fluzone SV98-99 USP on October 3,1998. Reportedly approximately oneand a half weeks later the patients complained of tingling down arm, impairs grip, intermittent. From additional information received on 11/23/98 it was reported, Reviewed, no additional information at this time. Follow up #1 (06/07/02): During internal auditing of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (Added Impaired  grip, Intermittent coded to neuropathy). During the second internal review of this file on 08/28/02, it was  deemed necessary to amend the report by changing the latest received date from 06/07/02 to the correct date of 06/06/02. The narritive was also updated to state that this is the report of references and U1998-00913 is the duplicate.									U	10/03/1998	10/10/1998	7		UNK	UNK					U1998007590	1						1	Asthenia; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0975670~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155111	06/21/2000	TN	65.0	65		M	02/01/2000	It was reported that a male pt received flu vax on 10/21/98. Subsequently he complained of malaise, then Transient Global Amnesia, confusion (i.e., put on tie and forgot shirt, unaware of date and time, unable to read clock). From additional information received on 02/01/99, additional pt, responsible information and laboratory data were given.				Y					U	10/21/1998	10/29/1998	8	LP, MRI (skull) - no results reported.	PVT	PVT		NONE	NONE		U1998007600	1						1	Amnesia; Confusional state; Malaise	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0155113	06/21/2000	MS	31.0	31		F	11/04/1998	Reportedly, the pt experienced an immediate reaction-redness, itching, warm to touch and itching around mouth. The pt was seen by a physician.				Y					U	11/04/1998	11/04/1998	0		UNK	UNK					U1998007670	1						1	Feeling hot; Injection site erythema; Pruritus	FLU3~CONNAUGHT LABORATORIES~0975830~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0155114	06/21/2000	WI	58.0	58		F	12/15/1998	About 5 minutes, post vax, the pt experienced a metallic taste in her mouth, which lasted about 1/2 hour and resolved. The pt recovered from this experience. From additional information received on 12/15/1998, it was reported, reviewed, no additional information at this time; 12/12/98.									Y	10/26/1998	10/26/1998	0		PUB	PVT	Synthroid	NONE	Allergies, perfumes, food preservatives, ASA, Asthma		U1998007680	1						1	Dysgeusia	FLU3~CONNAUGHT LABORATORIES~0980560~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155116	06/21/2000	WI	46.0	46		F	12/15/1998	Reportedly the pt,  immediately, experienced a metallic taste in her mouth which lasted about 1 1/2 hours and then resolved. The pt stated this happened 6 months ago after an injection of Toradol. Reportedly, the pt recovered from this experience. From additional information received on 12/15/98, it was reported, Reviewed, no additional information at this time, 12/11/1998.									Y	10/27/1998	10/27/1998	0		UNK	UNK	PPD-Tubersol-Connaught-246711	NONE	NONE		U1998007690	1						1	Dysgeusia	FLU3~CONNAUGHT LABORATORIES~0980560~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155118	06/21/2000	CT	40.0	39		F	11/23/1998	Reportedly, sometime after the vaccination, the pt experienced tingling sensation of right facial area. The pt also experienced discomfort of right clavicle and sternum (injection given in right deltoid), the discomfort moved to scalp and right ear. Reportedly, the pt was seen by physician, all signs and symptoms subsided now but lasted 1 week.				Y					Y	10/22/1998				UNK	UNK	NONE	NONE	NONE		U1998007700	1						1	Chest pain; Ear pain; Headache; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0968410~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0155120	06/21/2000	TX	51.0	51		M	12/23/1998	It was reported that a 51 year old male pt received Fluzone WV '98-'99 USP on 11/3/98. Reportedly, sometime, post vax, the pt experienced a hot area 1cm below injection site. From additional information received on 11/20/1998, it was reported that the pt recovered from this experience.									Y	11/03/1998				PVT	PVT					U1998007720	1						1	Feeling hot; Injection site reaction	FLU3~CONNAUGHT LABORATORIES~0973920~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155122	06/21/2000	FL	7.0	7		M	12/23/1999	It was reported that a 7 year old male received Fluzone SV '98-'99 USP on 11/3/98, and post vax, the pt experienced a syncopal episode lasting 60 seconds. From additional information received on 11/23/1998, it was reported that the pt recovered from this experience.									Y	11/03/1998	11/03/1998	0		PVT	PVT	NONE	NONE	Asthma		U1998007730	1						1	Syncope	FLU3~CONNAUGHT LABORATORIES~0971890~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155123	06/21/2000	CA	37.0			M	11/05/1998	It was reported that a 37 year old male received Fluzone SV '98-'99 USF on 10/23/98. Reportedly, 2 days, post vax, the pt experienced muscle aching, sore throat and fatigue, lasting for 2 weeks.									U	10/23/1998	10/25/1998	2		UNK	UNK					U1998007740	1						1	Fatigue; Myalgia; Pharyngolaryngeal pain	FLU3~CONNAUGHT LABORATORIES~0983300~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155125	06/21/2000	CA	38.0			F	11/05/1998	It was reported that a 38 year old female received Fluzone SV '98-'99 USP on 10/23/98, and 2 days, post vax, the pt experienced muscle aching, sore throat and fatigue lasting for 2 weeks.									U	10/23/1998	10/25/1998	2		UNK	UNK					U1998007750	1						1	Fatigue; Myalgia; Pharyngolaryngeal pain	FLU3~CONNAUGHT LABORATORIES~0983300~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155126	06/21/2000	CA	33.0			F	11/05/1998	It was reported that a 33 year old male received Fluzone SV '98-'99 USP on 10/23/1998. Reportedly, 2 days, post vax, the pt experienced muscle aching, sore throat and fatigue lasting for 2 weeks.									U	10/23/1998	10/25/1998	2		UNK	UNK					U1998007760	1						1	Fatigue; Myalgia; Pharyngolaryngeal pain	FLU3~CONNAUGHT LABORATORIES~0983300~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155128	06/21/2000	NC	45.0	45		F	12/22/1998	It was reported that a 45 year old female received Fluzone SV '98-'99 USP on 10/29/98 and reportedly that same day, the pt complained of sore arm, breathing rapid, fever, chills, body/muscle aches and rash on chest. Reportedly, the pt has not been assessed by a doctor. From additional information received on 11/16/98, it was reported, pt went to see her family physician on 11/3/98. He dx'd a bacterial infection of the chest and head, felt this infection was unrelated to the Flu vaccine. Reportedly the pt recovered from this experience. Also, reported was the pt's information, the responsible physician information, the time of vaccination and the tme of reaction.				Y					Y	10/29/1998	10/29/1998	0		PUB	UNK			NONE		U1998007770	1						1	Bacterial infection; Injection site pain; Pain; Pyrexia; Rash; Respiratory rate increased	FLU3~CONNAUGHT LABORATORIES~0984550~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0155129	06/21/2000	UT	42.0	42		M	12/23/1998	It was reported that a 42 year old male received Fluzone SV '98-'99 USP on 10/23/1998. Reportedly, on 10/31/1998, the pt experienced focal erythema, edema left deltoid to elbow and arthralgias, progressively worsening. Treated with prednisone which has reduced symptoms but not cleared up. From additional information received on 11/20/98, the pt's information and additional vaccination information was given.									N	10/23/1998	10/31/1998	8	NONE	OTH	OTH	Cipro for ear infection	Resolving ear infection	Environmental/perennial allergies		U1998007780	1						1	Arthralgia; Injection site erythema; Injection site oedema	FLU3~CONNAUGHT LABORATORIES~0978740~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155130	06/21/2000	WA	26.0	26		F	11/05/1998	Post vax, the pt experienced pain, numbness, and weakness of left arm.				Y					U	10/13/1998				UNK	UNK					U1998007790	1						1	Hypoaesthesia; Muscular weakness; Pain	FLU3~CONNAUGHT LABORATORIES~0981790~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0155133	06/21/2000	NC	47.0	57		F	11/18/1998	Post vax, the pt experienced hives, shortness of breath, and throat closing. Reportedly the pt was given epinephrine and taken to ER. The pt also experienced hypotension and was given Benadryl at ER as well.				Y					Y	11/05/1998				OTH	PVT	insulin, Vasotec, Premarin, Prozac		high blood pressure, insulin-dependent diabetes		U1998007800	1						1	Dyspnoea; Hypotension; Throat tightness; Urticaria	FLU3~CONNAUGHT LABORATORIES~0981790~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0155134	06/21/2000	AZ	76.0	76		F	11/06/1998	Post vax, the pt experienced immediate pain at the injection site, pain in arm, metallic taste in mouth, headache, feeling sick all over and felt unsteady on feet.				Y					U	11/05/1998	11/05/1998	0		UNK	UNK					U1998007810	1						1	Balance disorder; Dysgeusia; Headache; Injection site pain; Pain	FLU3~CONNAUGHT LABORATORIES~0988290~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0155135	06/21/2000	CA	2.0	2	.3	M	11/06/1998	Post vax, the pt experienced multiple bouts of emesis approximately 30 minutes after injection.									U	11/05/1998	11/05/1998	0		UNK	UNK					U1998007850	1						1	Vomiting	FLU3~CONNAUGHT LABORATORIES~098330~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155136	06/21/2000	IA				U	11/09/1998	Post vax, the pt complained of polymigratory arthralgia.									U					UNK	UNK					U1598007860	1						1	Arthralgia	FLU3~CONNAUGHT LABORATORIES~0971390~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155137	06/21/2000	CO				M	12/23/1998	The following day post vax, the pt experienced double vision. On 11/2/98, the pt was seen by an ophthalmologist and was dx with left VI nerve palsy.				Y					N					UNK	UNK					U1998007890	1						1	Diplopia; Facial palsy	FLU3~CONNAUGHT LABORATORIES~0965780~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0155138	06/21/2000	IA	50.0	50		F	12/01/1998	One half hour post vax, the pt experienced limited range of motion of left deltoid at site of injection and also pain into left hand. The pt reportedly was seen by physician 3 days later.				Y					U	11/06/1998	11/06/1998	0		OTH	OTH					U1998007910	1						1	Hypokinesia; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0974000~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0155139	06/21/2000	CT	41.0	41		F	11/10/1998	24 hours post vax, the pt experienced a huge 4 inch reaction that was slightly raised, red, and hot. Reportedly the reaction was gone by 11/9/98 and the pt recovered.									Y	11/06/1998	11/07/1998	1		UNK	UNK					U1998007950	1						1	Injection site hypersensitivity; Injection site swelling; Vasodilation procedure	FLU3~CONNAUGHT LABORATORIES~0984600~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155140	06/21/2000	CT	36.0	36		F	11/10/1998	24 hours post vax, the pt experienced a huge 4 inch reaction that was slightly raised, red, hot, and itchy.									Y	11/06/1998	11/07/1998	1		UNK	UNK					U1998007960	1						1	Injection site hypersensitivity; Injection site swelling; Pruritus; Vasodilation procedure	FLU3~CONNAUGHT LABORATORIES~0984600~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155141	06/21/2000	CT				U	11/10/1998	It was reported that a pt (no specifications were given) experienced an injection site reaction, post vax.									U					UNK	UNK					U1998007570	1						1	Injection site reaction	FLU3~CONNAUGHT LABORATORIES~0984600~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155142	06/21/2000	MN	31.0			F	11/11/1998	It was reported that a 31 year old female received Fluzone WV '98-'99 USP on 11/10/98. Reportedly, the pt stated she felt numbness and tingling in her arm immediately, post vax. The pt has not been evaluated by a physician.									U	11/10/1998	11/10/1998	0		UNK	UNK			Pt stated she had experienced this (the same reaction) the past 2 years after receiving a Flu shot and resolved on it's own.		U1998007980	1						1	Hypoaesthesia; Injection site reaction	FLU3~CONNAUGHT LABORATORIES~0984990~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155143	06/21/2000	FL	64.0	64		F	11/12/1998	It was reported that a 64 year old female received Fluzone SV '98-'99 USP on 10/6/98 and on 10/10/98, the pt complained of fever, vomiting, achy and cough.									U	10/06/1998	10/10/1998	4		UNK	UNK					U1998008020	1						1	Cough; Pain; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~0971390~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155144	06/21/2000	NY	68.0	68		F	12/04/1998	It was reported that a 68 year old female received Fluzone SV '98-'99 USP on 11/2/98 and 2 days, post vax, she experienced right neck discomfort; and 5 days had facial weakness. Reportedly, was seen in ER and dx'd with Bell's Palsy. From additional information received on 12/4/98, it was reported, follow-up 11/16/98 facial weakness improved.				Y					N	11/02/1998	11/04/1998	2		UNK	UNK		NONE	Hypertension, Glaucoma, history of depression		U1998008040	1						1	Facial palsy; Neck pain	FLU3~CONNAUGHT LABORATORIES~0981910~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0155145	06/21/2000	DC	39.0	39		M	11/18/1998	It was reported that a 39 year old male received Fluzone SV '98-'99 USP on 11/4/98 and on 11/6/98, the pt complained of uncontrollable body shaking, left hand felt asleep, and shortness of breath. Additional information received via phone conversation on 11/18/1998, it was reported that the pt is 95% better as of 11/18/98.									N	11/04/1998	11/06/1998	2		UNK	UNK					U199800808	1						1	Dyspnoea; Hypoaesthesia; Tremor	FLU3~CONNAUGHT LABORATORIES~0967040~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155146	06/21/2000	IL	45.0	45		F	12/01/1998	It was reported that a 45 year old female received Fluzone SV '98-'99 USP on 10/26/98 and on 10/29/98, the pt experienced urticaria of hands and any body part exposed to cold. Symptoms reportedly started, post vax. From additional information received on 11/30/98, it was reported, bee sting on 10/8/98 with slightly allergic reaction noted at the time, with swelling and itching.									U	10/26/1998	10/29/1998	3	NONE	OTH	PVT	NONE	NONE	Bee sting with allergic reaction on 10/8/98		U1998008090	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~0985870~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155147	06/21/2000	NY	31.0	31		F	12/14/1998	It was reported that a 31 year old female received Fluzone WV '98-'99 USP on 10/27/98. Recipient reported that at approximately 14:00, she began feeling hot with mucous rising in her throat. She began coughing and by 15:00, she was experiencing burning in her chest and throat, along with shortness of breath. She took Benadryl, which alieviated the burning in about 20 minutes. She called her MD, who prescribed more Bendadryl, mild tachypnea persisted until the following morning, when it resolved. From additional information received on 12/10/98, it was reported, Reviewed, no additional information at this time, 12/8/98.									Y	10/27/1998	10/27/1998	0		OTH	PVT	Tri-Levlen, Zyrtec	NONE	Multiple environmental allergies; trees, grass, molds, weeds.		U1998008110	1						1	Chest pain; Cough; Dyspnoea; Hot flush; Salivary hypersecretion; Tachypnoea	FLU3~CONNAUGHT LABORATORIES~0973930~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155148	06/21/2000	NY	24.0	24		F	12/02/1998	It was reported that a 24 year old female received Fluzone SV '98-'99 USP on 10/15/98 and the recipient reported that about 18:00, she began experiencing swollen fingers and itching arms. A bumpy rash developed in her forearms and traveled upward to her chest. She began experiencing chills and throat numbness. She contacted her physician who instructed her to take Benadryl. Her symptoms were allieviated by the following day.									Y	10/15/1998	10/15/1998	0		OTH	PVT	Depo-Provera	NONE	Recipient's father has Gullain-Barre Syndrome.		U1998008130	1						1	Chills; Oedema peripheral; Pruritus; Rash erythematous; Throat tightness	FLU3~CONNAUGHT LABORATORIES~0967040~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155149	06/21/2000	FL	69.0			F	08/06/2002	It was reported that a pt received Fluzone '97-'98 on 10/26/98 and some time, post vax, the pt experienced uncontrollable movement of the left arm and shoulder. The pt was seen by the reporting physician and treated with Haldol. The pt was also seen by a neurologist who continued Haldol treatments.  Follow up #1 19-Jun-2002:  During internal review of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (deleted tremor).				Y					N	10/26/1998				UNK	UNK					U1998008140	1						1	Dyskinesia	FLU3~CONNAUGHT LABORATORIES~0983290~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0155150	06/21/2000	ME	44.0	44		F	12/31/1998	On 11/6/98, the pt complained of supraclavicular swelling.				Y					N	11/04/1998	11/06/1998	2	blood work-nml	OTH	OTH		NONE	NONE		U1998008150	1						1	Swelling	FLU3~CONNAUGHT LABORATORIES~0969610~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1|TD~CONNAUGHT LABORATORIES~0977220~UNK~IM~~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0155151	06/21/2000	NJ	43.0			M	11/17/1998	A few days post vax, the pt was working in his yard, that night experienced left arm pain lasting for a week. On 10/29, the pt went to work even though bottoms of feet hurt. On 11/4, the bottoms of his feet were hurting again. On 11/9, the pt again had pain in feet and joint pain in hands and feet especially ankles, ankles swollen.				Y					U	10/19/1998	10/24/1998	5		UNK	UNK					U1998008160	1						1	Oedema peripheral; Pain	FLU3~CONNAUGHT LABORATORIES~0975780~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0155152	06/21/2000	NY	55.0	55		F	11/17/1998	Three days post vax, the pt developed easy bruising over ankles, knuckles, and abdomen. Pt was reportedly seen in office.				Y					U	11/10/1998	11/13/1998	3		UNK	UNK					U199800819(0)	1						1	Contusion	FLU3~CONNAUGHT LABORATORIES~0985920~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0155153	06/21/2000	NJ	49.0	49		M	12/08/1998	Several days post vax, the pt complained of myalgias, bilateral chest wall as well as lower extremity muscle weakness.				Y					Y	11/03/1998	11/07/1998	4	EKG, lab tests, CXR, stress test-all neg	OTH	PVT	NONE	NONE	NONE		U1998008250	1						1	Muscular weakness; Myalgia	FLU3~CONNAUGHT LABORATORIES~0965770~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0155154	06/21/2000	WI	59.0	59		F	12/17/1998	On 11/21/98, the pt experienced a local reaction at the injection site. Pt had an approximately 14 cm irregular redness in a circle around injection site. This resolved in a couple of days.									Y	11/19/1998	11/21/1998	2		PUB	UNK	Provera, Premarin	NONE	allergy to erythromycin, tetanus, high blood pressure		U1998008410	1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~0989920~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155155	06/21/2000	WI	59.0	59		F	12/15/1998	Within a half an hour post vax, the pt experienced a slight metallic taste in her mouth. Reportedly by 10/30 the taste was very strong, like sucking on a rusty spoon.									Y	10/26/1998	10/26/1998	0	NONE	PUB	PVT	Premarin, sulfa, Voltaren	bladder infection	arteritis		U1998008450	1						1	Dysgeusia	FLU3~CONNAUGHT LABORATORIES~0980560~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155156	06/21/2000	PA				F		Post vax, the pt experienced a burning sensation and immediately a red welt appeared, which turned into a hard lump with 3 inch erythema. Reportedly the pt recovered from this experience.									Y	11/17/1998	12/17/1998	30		OTH	UNK					U1998008590	1						1	Erythema; Skin burning sensation; Skin nodule; Urticaria	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155157	06/21/2000	CO	46.0	46		F	01/11/1999	On 11/6/98, the pt experienced hypersensitivity Vasculitis. The pt had presented to physician with myalgia, arthralgia, swelling in her joints, and local reaction.				Y					U	10/28/1998	11/06/1998	9		UNK	UNK					U1998008610	1						1	Arthralgia; Injection site reaction; Joint swelling; Leukocytoclastic vasculitis; Myalgia	FLU3~CONNAUGHT LABORATORIES~0984620~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0155158	06/21/2000	LA	70.0	70		M	02/02/1999	On 10/14/98, the pt experienced a bitter taste in mouth.									N	10/07/1998	10/14/1998	7		PVT	OTH			allergy to PCN and sulfa		U1998008790	1						1	Dysgeusia	FLU3~CONNAUGHT LABORATORIES~0975810~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155159	06/21/2000	NY	52.0			F	12/31/1998	On 12/3/98, the pt experienced pain of entire arm.									U	12/02/1998	12/03/1998	1		PVT	OTH	Synthroid				U1998008840	1						1	Pain	FLU3~CONNAUGHT LABORATORIES~0988270~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155160	06/21/2000	MI	43.0			M	02/18/1999	2 days post vax, the pt experienced facial nerve problems. The muscles in the pt's face felt very tight, which started on both sides of face in the temple region, traveling down to jaw making teeth feel numb and sometimes even traveling down to throat making it difficult to swallow. Reportedly during the times of severe tightness the pt's skin would appear to lose its ability to feel soft sensations, however could feel heavy pressures, there was no motor control loss nor any sharp pain. It's been about two months now and even though I believe it is starting to subside, the problem is still rather severe.									N					UNK	UNK			facial problems		U1998009140	1						1	Dysphagia; Hypoaesthesia; Neuropathy	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155161	06/21/2000	NY	50.0	50		M	01/13/1999	Four hours post vax, the pt developed a fever, chills, and tightness in his throat/chest. Because of his preexisting cardiac problems, he went to the ER. He was advised to rest, drink plenty of fluids, and take some Tylenol.				Y					Y	12/08/1998	12/08/1998	0	NONE	PVT	PVT	Procardia, Atenolol		unspecified cardiac condition, hypertension, arteriosclerosis		U1998009200	1						1	Chest discomfort; Pyrexia; Throat tightness	FLU3~CONNAUGHT LABORATORIES~0984530~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0155162	06/21/2000	NY	30.0	30		F	01/11/1999	Post vax, the pt reportedly experienced a fifty cent sized red raised area at injection site.									U	01/05/1999				UNK	UNK					U1999000250	1						1	Injection site swelling	FLU3~CONNAUGHT LABORATORIES~0984550~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155163	06/21/2000	PA	79.0	79		F	01/11/1999	It was reported that the pt inadvertently received 2 doses of vax of 9/21/98 one hour apart. No adverse experience occurred and the pt reportedly recovered from this experience.									Y	09/21/1998				PVT	UNK	Voltaren, Norvasc, Tylenol, Lasix, glucosamine sulfate, vitamin B12 injections		hypertension, hypothyroidism, GERD		U1999000330	1						1	Unevaluable event	FLU3~CONNAUGHT LABORATORIES~0967040~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155164	06/21/2000	PA	81.0	81		M	01/11/1999	It was reported that this pt inadvertently received two doses of vax on 9/21/98 one hour apart. No adverse reactions occurred and the pt reportedly recovered from this experience.									Y	09/21/1998				UNK	UNK	Glucotrol, Ecotrin, Cardizem	NONE	diabetes mellitus, diverticulitis, benign prostatic hypertrophy, hypertension, peripheral vascular disease		U199900034	1						1	Unevaluable event	FLU3~CONNAUGHT LABORATORIES~0967040~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155165	06/21/2000	WA	67.0	66		M	02/08/1999	3 to 5 days post vax, the pt developed hives and a swollen tongue. The signs and symptoms have lasted since October, the pt is being seen by an allergist.				Y					N	10/15/1998	10/18/1998	3		OTH	PVT	prednisone, Parlocel, testosterone, Syntroid, Beconase, pituitary replacement	NONE	tumor irradiated in 1975		U1999000370	1						1	Tongue oedema; Urticaria	FLU3~CONNAUGHT LABORATORIES~0973580~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0155167	06/21/2000	NY	71.0	71		F	02/08/1999	The next day post vax, the pt experienced pain in both wrists, then in back of neck and ankles.									U	10/15/1998	10/16/1998	1		PVT	PVT	Accupril, Lopressor, Xanax, Halcion,	NONE	hypertension, gastritis, anxiety disorder		U1999000490	1						1	Pain	FLU3~CONNAUGHT LABORATORIES~0973920~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155168	06/21/2000	MI	76.0	76		F	01/28/1999	Post vax, the pt stated to her doctor that she experienced flu-like symptoms, chills, and diarrhea.									U	11/05/1998				UNK	UNK					U1999000600	1						1	Chills; Diarrhoea; Influenza like illness	FLU3~CONNAUGHT LABORATORIES~0967040~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155169	06/21/2000	NJ				F	02/01/1999	Subsequently post vax, the pt developed an injection site reaction.									U	10/06/1998				PVT	OTH					U1999000670	1						1	Injection site reaction	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155170	06/21/2000	PA	48.0	48		F	02/16/1999	Pt's vax dose was given to high. She reportedly felt an electrical shock when the injection went in. The pt experienced swelling into bicep with burning and pain with tingling immediately. Reportedly the pt had her fibromyalgia set-off again and was seen by a physician who has been treating the pt for this condition. The pt is still experiencing a big lump under arm the size of a golf ball with a lot of pain.				Y					U	10/07/1998	10/07/1998	0		OTH	OTH			fibromyalgia		U1999000690	1						1	Condition aggravated; Fibromyalgia; Injection site pain; Oedema peripheral; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0977180~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0119070	06/22/2000	CA	44.0	44		F	02/11/1999	diarrhea 8FEB99PM took med & went to work;9FEB99 3:00 started to have h/a & took APAP but h/a inc;by 7AM so severe w/nausea & neck pain-stiff neck & upper back pain;to ER;				Y					Y	01/07/1999	01/08/1999	1	SMA 20;CBC; 11JAN99 WBC sl inc to 11 thousand;	PUB	PUB	NONE	NONE	NONE	NA~ ()~~~In patient	CA990010	1						1	Back pain; Diarrhoea; Headache; Leukocytosis; Nausea; Neck pain; Back pain; Diarrhoea; Headache; Leukocytosis; Nausea; Neck pain	FLU3~CONNAUGHT LABORATORIES~10988290~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~10988290~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0119070	06/22/2000	CA	44.0	44		F	02/11/1999	diarrhea 8FEB99PM took med & went to work;9FEB99 3:00 started to have h/a & took APAP but h/a inc;by 7AM so severe w/nausea & neck pain-stiff neck & upper back pain;to ER;				Y					Y	01/07/1999	01/08/1999	1	SMA 20;CBC; 11JAN99 WBC sl inc to 11 thousand;	PUB	PUB	NONE	NONE	NONE	NA~ ()~~~In patient	CA990010	1						2	Back pain; Diarrhoea; Headache; Leukocytosis; Nausea; Neck pain; Back pain; Diarrhoea; Headache; Leukocytosis; Nausea; Neck pain	FLU3~CONNAUGHT LABORATORIES~10988290~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~10988290~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0121567	06/22/2000	NY	0.5	0	.5	M	02/10/1999	pt recv vax 17NOV98 & 19NOV98 pt devel watery diarrhea which persisted for 7 days;									Y	11/17/1998	11/19/1998	2	unk	PVT	OTH	unk	NONE	premature birth @ 25wk gestation, bronchopulmonary dysplasia	pt had no adverse exp p/2nd & 3rd dose or Rota Shield~ ()~~~In patient	899055004A	1						1	Diarrhoea; Diarrhoea	FLU3~CONNAUGHT LABORATORIES~0981820~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|RV~PFIZER\WYETH~~1~PO~MO~ROTAVIRUS (ROTASHIELD)~1|FLU3~CONNAUGHT LABORATORIES~0981820~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|RV~PFIZER\WYETH~~1~PO~MO~ROTAVIRUS (ROTASHIELD)~2	USA		Influenza
0121567	06/22/2000	NY	0.5	0	.5	M	02/10/1999	pt recv vax 17NOV98 & 19NOV98 pt devel watery diarrhea which persisted for 7 days;									Y	11/17/1998	11/19/1998	2	unk	PVT	OTH	unk	NONE	premature birth @ 25wk gestation, bronchopulmonary dysplasia	pt had no adverse exp p/2nd & 3rd dose or Rota Shield~ ()~~~In patient	899055004A	1						2	Diarrhoea; Diarrhoea	FLU3~CONNAUGHT LABORATORIES~0981820~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|RV~PFIZER\WYETH~~1~PO~MO~ROTAVIRUS (ROTASHIELD)~1|FLU3~CONNAUGHT LABORATORIES~0981820~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|RV~PFIZER\WYETH~~1~PO~MO~ROTAVIRUS (ROTASHIELD)~2	USA		Influenza
0125809	06/22/2000	CA	0.2	0	.2	M	05/27/1999	p/vax pt seen by MD w/persistent crying possibly d/t abd pain;it was determined that pt had an elevated ESR;				Y					U	04/28/1999	05/22/1999	24	erythrocyte sedimentation rate increased	PVT	OTH	NONE	NONE	unk	unk~ ()~~~In patient	899153004A	1						1	Abdominal pain; Agitation; Red blood cell sedimentation rate increased; Abdominal pain; Agitation; Red blood cell sedimentation rate increased; Abdominal pain; Decreased appetite; Irritability; Red blood cell sedimentation rate increased	DTP~UNKNOWN MANUFACTURER~~UNK~~~DTP (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|HIBV~PFIZER\WYETH~~UNK~~~HIB (HIBTITER)~1|IPV~CONNAUGHT LTD.~~UNK~~~POLIO VIRUS, INACT. (POLIOVAX)~1|RV~PFIZER\WYETH~~1~PO~MO~ROTAVIRUS (ROTASHIELD)~1|DTP~UNKNOWN MANUFACTURER~~UNK~~~DTP (NO BRAND NAME)~2|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~2|HIBV~PFIZER\WYETH~~UNK~~~HIB (HIBTITER)~2|IPV~CONNAUGHT LTD.~~UNK~~~POLIO VIRUS, INACT. (POLIOVAX)~2|RV~PFIZER\WYETH~~1~PO~MO~ROTAVIRUS (ROTASHIELD)~2|DTAP~CONNAUGHT LABORATORIES~7389AA~1~IM~LL~DTAP (TRIPEDIA)~3|FLU3~PFIZER\WYETH~~1~PO~MO~INFLUENZA (SEASONAL) (FLUSHIELD)~3|HEP~SMITHKLINE BEECHAM~2931A2~2~IM~RL~HEP B (ENGERIX-B)~3|HIBV~CONNAUGHT LABORATORIES~N07022A~1~IM~LL~HIB (ACTHIB)~3|IPV~CONNAUGHT LTD.~P0167~1~SC~RL~POLIO VIRUS, INACT. (POLIOVAX)~3	USA	Emergency room visit	Influenza
0125809	06/22/2000	CA	0.2	0	.2	M	05/27/1999	p/vax pt seen by MD w/persistent crying possibly d/t abd pain;it was determined that pt had an elevated ESR;				Y					U	04/28/1999	05/22/1999	24	erythrocyte sedimentation rate increased	PVT	OTH	NONE	NONE	unk	unk~ ()~~~In patient	899153004A	1						2	Abdominal pain; Agitation; Red blood cell sedimentation rate increased; Abdominal pain; Agitation; Red blood cell sedimentation rate increased; Abdominal pain; Decreased appetite; Irritability; Red blood cell sedimentation rate increased	DTP~UNKNOWN MANUFACTURER~~UNK~~~DTP (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|HIBV~PFIZER\WYETH~~UNK~~~HIB (HIBTITER)~1|IPV~CONNAUGHT LTD.~~UNK~~~POLIO VIRUS, INACT. (POLIOVAX)~1|RV~PFIZER\WYETH~~1~PO~MO~ROTAVIRUS (ROTASHIELD)~1|DTP~UNKNOWN MANUFACTURER~~UNK~~~DTP (NO BRAND NAME)~2|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~2|HIBV~PFIZER\WYETH~~UNK~~~HIB (HIBTITER)~2|IPV~CONNAUGHT LTD.~~UNK~~~POLIO VIRUS, INACT. (POLIOVAX)~2|RV~PFIZER\WYETH~~1~PO~MO~ROTAVIRUS (ROTASHIELD)~2|DTAP~CONNAUGHT LABORATORIES~7389AA~1~IM~LL~DTAP (TRIPEDIA)~3|FLU3~PFIZER\WYETH~~1~PO~MO~INFLUENZA (SEASONAL) (FLUSHIELD)~3|HEP~SMITHKLINE BEECHAM~2931A2~2~IM~RL~HEP B (ENGERIX-B)~3|HIBV~CONNAUGHT LABORATORIES~N07022A~1~IM~LL~HIB (ACTHIB)~3|IPV~CONNAUGHT LTD.~P0167~1~SC~RL~POLIO VIRUS, INACT. (POLIOVAX)~3	USA	Emergency room visit	Influenza
0127961	06/22/2000	TX	39.0	39		F	03/16/1999	It was reported, A nurse reported that a 39 year old female received injections of Pnu-Immune 23 and Fluzone on 10/7/98. The next evening, the pt developed a warmth, pain and hives at the site of the Pnu-Immune 23 administration. She was treated with topical and oral Benadryl. The hives subsided in 3 days.									Y	10/07/1998	10/08/1998	1		PVT	PVT	Beclovent, Nasalcrom, Entex LA, Effexor, trazodone, Buspar, Axid, Naprelan	NONE	Perennial allergies, depression, GERD, osteoarthritis, asthma		U1999001550	1						2	Feeling hot; Injection site pain; Urticaria	FLU3~CONNAUGHT LABORATORIES~0968380~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~448192~1~IM~LA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0132118	06/22/2000	AL	39.0	39		F	12/03/1999	Employee tested Rubella non-immune; Rubeola immune W/ 1.26 level. Mild rash. Presented w/ rash over entire body, pain in joints, & redness in sclera.				Y					N	11/18/1999	12/02/1999	14	NONE	PVT	PVT	Prilosec	NONE	NONE	~ ()~~~In patient		1						1	Arthralgia; Conjunctivitis; Rash; Arthralgia; Conjunctivitis; Rash	FLU3~CONNAUGHT LABORATORIES~40129AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1147J~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|FLU3~CONNAUGHT LABORATORIES~40129AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|MMR~MERCK & CO. INC.~1147J~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~2	USA	Emergency room visit	Influenza
0132118	06/22/2000	AL	39.0	39		F	12/03/1999	Employee tested Rubella non-immune; Rubeola immune W/ 1.26 level. Mild rash. Presented w/ rash over entire body, pain in joints, & redness in sclera.				Y					N	11/18/1999	12/02/1999	14	NONE	PVT	PVT	Prilosec	NONE	NONE	~ ()~~~In patient		1						2	Arthralgia; Conjunctivitis; Rash; Arthralgia; Conjunctivitis; Rash	FLU3~CONNAUGHT LABORATORIES~40129AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1147J~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|FLU3~CONNAUGHT LABORATORIES~40129AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|MMR~MERCK & CO. INC.~1147J~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~2	USA	Emergency room visit	Influenza
0152778	06/22/2000	SC	51.0	51		F	02/24/1999	Three days post vax, the pt experienced systemic reactions of headache, general malaise, fever, nausea, vomiting, and myalgia, stomach pain, diarrhea and sniffles which lasted for 3 days.									Y	10/09/1998	10/12/1998	3		PUB	PUB		NONE	NONE		U1998006350	1						2	Diarrhoea; Headache; Nausea; Rhinorrhoea; Abdominal pain upper; Diarrhoea; Headache; Malaise; Myalgia; Nausea; Pyrexia; Rhinorrhoea; Vomiting	FLU3~CONNAUGHT LABORATORIES~0980580~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~0980580~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0155091	06/22/2000	CA	0.2	0	.2	M	08/04/1999	Within 2 days post vax, the infant developed diarrhea and vomiting, which persisted as of 6/4/99.									U	06/01/1999	06/01/1999	0	UNK	OTH	OTH		NONE	UNK		U1999005450	1						3	Diarrhoea; Gastroenteritis; Vomiting; Diarrhoea; Vomiting; Diarrhoea; Vomiting	DTAP~CONNAUGHT LABORATORIES~~1~IM~~DTAP (TRIPEDIA)~1|HEP~SMITHKLINE BEECHAM~~2~IM~~HEP B (ENGERIX-B)~1|HIBV~MERCK & CO. INC.~1204B~1~IM~~HIB (PEDVAXHIB)~1|IPV~PASTEUR MERIEUX INST.~~1~SC~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|RV~PFIZER\WYETH~~1~PO~MO~ROTAVIRUS (ROTASHIELD)~1|DTAP~CONNAUGHT LABORATORIES~6F81445~1~IM~~DTAP (TRIPEDIA)~2|FLU3~PFIZER\WYETH~4988139~1~PO~MO~INFLUENZA (SEASONAL) (FLUSHIELD)~2|HEP~SMITHKLINE BEECHAM~2919A2~2~IM~~HEP B (ENGERIX-B)~2|HIBV~MERCK & CO. INC.~1204E~1~IM~~HIB (PEDVAXHIB)~2|IPV~CONNAUGHT LTD.~M0212~1~SC~~POLIO VIRUS, INACT. (POLIOVAX)~2|DTAP~PFIZER\WYETH~~UNK~IM~~DTAP (ACEL-IMUNE)~3|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~3|HIBV~PFIZER\WYETH~~UNK~IM~~HIB (HIBTITER)~3|IPV~PFIZER\WYETH~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~3|RV~PFIZER\WYETH~~1~PO~MO~ROTAVIRUS (ROTASHIELD)~3	USA		Influenza
0155214	06/22/2000	IN	47.0	47		F	05/03/2001	Reportedly, sometime, post vax, the pt experienced pain in her arm at the injection site, left deltoid. From additional info received on 03/12/1999, additional pt, responsible physician and vaccine administrator info were given. From follow-up correspondence received on 04/26/2001, it was reported, No further info available regarding this pt or this case. This case is closed.									U	10/22/1998				PVT	PVT		NONE			U1999001000	1						1	Injection site pain	FLU3~CONNAUGHT LABORATORIES~0971890~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155215	06/22/2000	TX	53.0	52		F	03/12/1999	Reportedly, the pt developed shoulder capsulitis on 11/23/98. The pt was reportedly seen by a neurologist on 11/24/98.				Y					U	10/22/1998	11/23/1998	32	MRI-shoulder	OTH	PVT		UNK	UNK		U1999001010	1						1	Arthritis	FLU3~CONNAUGHT LABORATORIES~0968380~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0155216	06/22/2000	MI				F	02/26/1999	It was reported that a female pt received Fluzone SV '98-'99 USP on 11/27/98 and reportedly, the pt has asthma and an allergy to feathers, and was told by allergists to receive IZ. The pt experienced a local reaction, numb limps, and lightheadedness that evening of the vaccination.									U	11/27/1998	11/27/1998	0		UNK	UNK			Asthma and allergy to feathers		U1999001230	1						1	Dizziness; Hypoaesthesia oral; Injection site reaction	FLU3~CONNAUGHT LABORATORIES~0984540~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155218	06/22/2000	PA	48.0	47		M	04/15/1999	It was reported that a 48 year old male received Fluzone SV '98-'99 USP vaccine on 11/6/98. Reportedly, on 11/9/98, in the morning, the pt had left side of face paralysis, which lasted 4 to 5 hours. Experienced difficulty sleeping at night. Continued to experience hot and cold episodes and ringing in ears. On 3/17/99, pt stated still experiencing the ringing of ears and difficulty sleeping. From additional information received via phone, on 3/31/99, it was reported that from his conversation with pt on 3/29/99, the pt stated the paralysis has decreased but is still experiencing ringing in ears and difficulty sleeping. From additional correspondence, received on 4/15/99, it was reported, Reviewed, no additional information at this time.				Y					N	11/06/1998	11/09/1998	3	MRI-revealed inflammed cranial nerves 7 & 8 level.	OTH	OTH	Lipitor	NONE	Hypercholesterolemia		U1999002050	1						1	Facial palsy; Feeling cold; Hot flush; Insomnia; Neuritis cranial; Tinnitus	FLU3~CONNAUGHT LABORATORIES~0577210~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0155219	06/22/2000	MO	68.0	67		F	04/19/1999	Two days post vax, this pt experienced induration and redness at injection site for one week. The pt reportedly recovered from this experience. It was noted that the flu vax may have been given SQ.									Y	02/06/1999	02/08/1999	2		PVT	PVT		NONE			U1999002630	1						1	Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~0981830~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~1247H~1~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0155220	06/22/2000	TX				U	04/23/1999	This pt experienced flu-like symptoms post flu vax.									U					UNK	UNK					U1999002760	1						1	Influenza like illness	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155221	06/22/2000	TX				U	04/23/1999	A Patient experienced flu-like symptoms post flu vax.									U					UNK	UNK					U1959002770	1						1	Influenza like illness	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155222	06/22/2000	TX				U	04/23/1999	This pt experienced flu-like symptoms post flu vax.									U					UNK	UNK					U1999002780	1						1	Influenza like illness	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155223	06/22/2000	TX				U	04/23/1999	This pt experienced flu-like symptoms post flu vax.									U					UNK	UNK					U1999002790	1						1	Influenza like illness	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155224	06/22/2000	TX				U	04/23/1999	This pt experienced flu-like symptoms post flu vax.									U					UNK	UNK					U1999002800	1						1	Influenza like illness	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155225	06/22/2000	MN	48.0	48		F	05/25/1999	It was reported that a 48-year-old female received vax on 10/27/1998. One day post administration, the pt complained of rash on upper extremities, uncontrollable crying, and difficulty moving legs, 20 minute intervals. Reports states that on 11/2 pt saw physician and reports rash due to chemicals at work.  Physician ordered cream for rash. On 02/12/99, pt went to ER complaining of toxic reaction to lacquer, uncontrollable crying, red blotches on skin. ER stated she was not having a toxic reaction. 03/01, pt again went to ER complaining of rash and crying, and ER report stated she's intent on finding a way out of work. Allegra 60mg, twice a day and Medrol Dose Pak was ordered. 03/03 Pt went to ER complaining of pruritic rash on arm. Allegra continued, dose pack stopped. 05/05/99 this was reviewed and no further information is known at this time.				Y					U	10/27/1998	10/28/1998	1		OTH	UNK					U1999003070	1						1	Crying; Hypokinesia; Pruritus; Rash; Rash macular	FLU3~CONNAUGHT LABORATORIES~0981860~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0155226	06/22/2000	FL				F	06/18/1999	Sometime following the vax, the pt's injection site became reddened, swollen, painful and warm to the touch, and developed a hard knot.									U					UNK	UNK					U1999004190	1						1	Injection site erythema; Injection site mass; Injection site oedema; Injection site pain; Injection site warmth	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0155241	06/22/2000	MD	53.0	53		M	05/23/2000	At end of 1/2000, had myalgia (calf muscles); 2/2000, had difficulty walking steps, weakness in legs. Consult of neurologist, admission to hospital on 3/17/2000 through 4/03/2000, disabled 3/10/2000 ff. Dx'd with GBS;CHD;Sarcoidosis. On 6/16/2000, still has nerve damage and trouble walking, will call back in 2 weeks. Diagnosed with Chronic inflamatory demylelinating polymeuropathy				Y	Y	17	Y		N	12/22/1999	01/27/2000	36	MRI, LP	PUB	PUB	NONE	NONE	NONE		MD00007	1						1	Cardiac failure congestive; Difficulty in walking; Muscular weakness; Myalgia; Neuropathy; Sarcoidosis; Demyelination; Difficulty in walking; Muscular weakness; Myalgia; Demyelination; Difficulty in walking; Guillain-Barre syndrome; Muscular weakness; Myalgia; Sarcoidosis	FLU3~PFIZER\WYETH~4998249~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEPA~SMITHKLINE BEECHAM~639B6~1~IM~LA~HEP A (HAVRIX)~1|FLU3~PFIZER\WYETH~4998249~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|HEPA~SMITHKLINE BEECHAM~639B6~1~IM~LA~HEP A (HAVRIX)~2|FLU3~PFIZER\WYETH~4998249~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~3|HEPA~SMITHKLINE BEECHAM~639D6~1~IM~LA~HEP A (HAVRIX)~3	USA	Hospitalisation	Influenza
0155322	06/22/2000	IL	0.2	0	.2	M	03/06/2000	It was reported, A physician reported that a 2 month old male pt received his 1st dose of Rota Shield, as well as, DTAP, Hib, IPV and Hep-B vaccines on 6/4/99. Three days later, the infant developed recurrent episodes of fever every 4 hours; his temperature went as high as 102F. It was reported that the pt recovered from this experience. From follow up #1 correspondence received on 05/25/01, it was reported, No further information at this time. -(05/19/01). This case is closed									Y	06/04/1999	06/07/1999	3	CBC, Blood cultures, UA and urine cultures, CXR-normal	PVT	PVT		NONE	NKA		U199900653	1						1	Pyrexia; Irritability; Pyrexia	DTAP~PFIZER\WYETH~~1~IM~~DTAP (ACEL-IMUNE)~1|HEP~UNKNOWN MANUFACTURER~~1~IM~~HEP B (NO BRAND NAME)~1|HIBV~PFIZER\WYETH~~1~IM~~HIB (HIBTITER)~1|IPV~PASTEUR MERIEUX INST.~~1~SC~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|RV~PFIZER\WYETH~4988131~1~PO~MO~ROTAVIRUS (ROTASHIELD)~1|DTAP~PFIZER\WYETH~462312~1~IM~LL~DTAP (ACEL-IMUNE)~2|FLU3~PFIZER\WYETH~4988131~1~PO~MO~INFLUENZA (SEASONAL) (FLUSHIELD)~2|HEP~SMITHKLINE BEECHAM~ENG2909A2~2~IM~RL~HEP B (ENGERIX-B)~2|HIBV~PFIZER\WYETH~412353A~1~IM~LL~HIB (HIBTITER)~2|IPV~CONNAUGHT LTD.~P0040~1~SC~RL~POLIO VIRUS, INACT. (POLIOVAX)~2	USA		Influenza
0129710	06/27/2000	OR	55.0	55		F	01/18/2000	Subsequent to vax, this pt developed severe myalgia, arthralgia, diarrhea, nausea, facial skin burning, fluid retention, muscle spasms, intermittent shortness of breath, and fatigue with weakness. The pt was treated with low-dose steroids. She is feeling much better as of 12/08/00 but still seems to have heightened sensitivity to most meds.									Y	10/06/1999			UNK	PVT	OTH	Estrogen	NONE	UNK		HQ2796319OCT1999	1						2	Arthralgia; Asthenia; Diarrhoea; Dyspnoea; Fatigue; Fluid retention; Muscle spasms; Myalgia; Nausea; Skin burning sensation	FLU3~PFIZER\WYETH~499822~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0129887	06/27/2000	GA	46.0	46		F	01/12/2000	Within 45 minutes post vax, this pt developed swelling and flushing of the face and lips and chest and an injection site reaction characterized by swelling and itching. Benadryl and Medrol were prescribed. She recovered within 24 hours post vax.									Y	10/11/1999	10/11/1999	0	UNK	PVT	PVT	UNK	NONE	UNK		HQ2561114OCT1999	1						3	Face oedema; Pain; Urticaria; Face oedema; Pain; Urticaria; Face oedema; Flushing; Injection site oedema; Pruritus; Swelling	FLU3~PFIZER\WYETH~4998218~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4998218~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|FLU3~PFIZER\WYETH~4998218~3~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~3	USA		Influenza
0155418	06/27/2000	TN	21.0	21		M	06/16/2000	Onset of fever, chills and sore throat on 6/8/00. Onset of weakness in hands and legs on 6/11/00. Admitted to the hospital on 6/14/2000 and still hospitalized at the time of this report. Treatment with IVIG. Dx Guillain-Barre.				Y	Y		Y		U	05/12/2000	06/11/2000	30		MIL	MIL	PPD/Connaught/Lot #25071 on 5/12/00.	NONE	NONE			1						1	Asthenia; Guillain-Barre syndrome; Pharyngolaryngeal pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0135AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~CONNAUGHT LABORATORIES~UA170AA~UNK~~~MENINGOCOCCAL (MENOMUNE)~1|TD~LEDERLE LABORATORIES~4988121~UNK~IM~~TD ADSORBED (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0155419	06/27/2000	OH	19.0	19		M	06/16/2000	06/09, swollen, painful ankles. 06/10, admission to hospital. Documented bilateral ankle inflammation, arthritis slowly improving with NSAID. Discharged 06/16 with continued mild active arthritis. Reactive arthritis.				Y	Y	6	Y		U	06/08/2000	06/09/2000	1		UNK	UNK	PPD/Connaught/Lot #250711 on 6/8/2000.	NONE	NONE			1						1	Arthralgia; Arthritis; Joint swelling	DT~LEDERLE LABORATORIES~471641~UNK~~~DT ADSORBED (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~0168AA~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|MEN~SANOFI PASTEUR~170AA~UNK~~~MENINGOCOCCAL (MENOMUNE)~1	USA	Hospitalisation	Influenza
0155420	06/27/2000	NY	19.0	19		M	06/16/2000	On 6/4/00, the pt developed fever, chills, and a cough. On 6/12/00, he developed lower extremity weakness. On 6/14/00, he was admitted to the hospital and treated with IV immunoglobulins. Dx with Guillain-Barre Syndrome.				Y	Y		Y		U	05/19/2000	06/14/2000	26		MIL	MIL	PPD/Connaught/Lot #25071 on 5/19/2000.	NONE	NONE			1						1	Cough; Guillain-Barre syndrome; Muscular weakness; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0169AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~CONNAUGHT LABORATORIES~UA170AA~UNK~SC~~MENINGOCOCCAL (MENOMUNE)~1|TTOX~LEDERLE LABORATORIES~4988121~UNK~IM~~TETANUS TOXOID, ADSORBED (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0155421	06/27/2000	FL	19.0	18		M	06/16/2000	Bilateral ankle swelling, pain beginning 06/13. Admission to hospital on 06/14. Hospitalized at time of report. Documented bilateral ankle inflammatory arthritis. Reactive Arthritis.				Y	Y				U	06/10/2000	06/13/2000	3		MIL	MIL	PPD/Connaught/Lot #250711 on 6/10/2000.	NONE	NONE			1						1	Arthralgia; Arthritis; Joint swelling	FLU3~CONNAUGHT LABORATORIES~U0168AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~CONNAUGHT LABORATORIES~UA170AA~2~SC~LA~MENINGOCOCCAL (MENOMUNE)~1|TD~LEDERLE LABORATORIES~471641~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0155472	06/27/2000	OR	51.0	51		F	05/17/2000	Headache for three days with vomiting and lethargy.									Y	10/26/1999	10/26/1999	0		MIL	PUB						1						1	Headache; Lethargy; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E27989HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0155473	06/27/2000	OR	51.0	51		M	02/10/2000	Severe itching for one week.									Y	10/15/1999	10/15/1999	0		MIL	PUB						1						1	Pruritus	FLU3~MEDEVA PHARMA, LTD.~E27989HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0155474	06/27/2000	OR	22.0	32		M	02/10/2000	Headache for four days immediately post vax.									Y	10/20/1999	10/20/1999	0		MIL	PUB						1						1	Headache	FLU3~MEDEVA PHARMA, LTD.~E27989HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0155494	06/27/2000	CO	47.0	47		F	12/15/1999	Within minutes post vax, the pt developed an anaphylactic reaction characterized by narrowing of the pt's airway, swollen tongue, and shortness of breath. The pt was treated in the ER. A week post vax the pt developed cold symptoms and a cough.			Y	Y					Y	11/18/1999	11/18/1999	0	UNK	PVT	OTH	Arthrotec, estrogen, Klonopin, Lortab	UNK	UNK		HQ5738216NOV1999	1						1	Anaphylactic reaction; Cough; Dyspnoea; Pharyngitis; Rhinitis; Tongue oedema	FLU3~PFIZER\WYETH~4998259~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening	Influenza
0155495	06/27/2000	CT				U	12/09/1999	Fever. A physician reported that a pt received an injection of Flu Shield and within 6 hours, developed a fever which persisted for 7 days, and the pt was hospitalized. This is 1 of 2 reports from this facility of adverse events post vax of this Flu Shield lot.				Y	Y				U				UNK	PVT	OTH	UNK	UNK	UNK		HQ7088101DEC1999	1						1	Pyrexia	FLU3~PFIZER\WYETH~4998229~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0155496	06/27/2000	TX	10.0	10		F	01/27/2000	A physician reported that a 10 year old female, post vax, developed a fever of 104 to 105F, chills, body aches, cough and nasal drainage. A dx of influenza was made; however, the type was not specified.									U	10/08/1999	12/20/1999	73	UNK	PVT	PVT	Bromfed PD, Vancenase	NONE	UNK		HQ0166104JAN2000	1						1	Cough; Influenza; Pain; Pyrexia; Rhinorrhoea	FLU3~PFIZER\WYETH~4998287~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155497	06/27/2000	TX				F	01/27/2000	A physician reported that a female, post vax, developed a fever of 104 to 105F, chills, body aches, cough and nasal drainage. A dx of influenza was made; however, the type was not specified.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ0520717JAN2000	1						1	Cough; Influenza; Pain; Pyrexia; Rhinorrhoea	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155498	06/27/2000	TX	7.0	7		M	01/27/2000	A physician reported that a 7 year old male, post vax, developed a fever of 104 to 105F, chills, body aches, cough and nasal drainage. A dx of influenza was made; however, the type was not specified.									U	10/08/1999	12/20/1999	73	UNK	PVT	PVT	albuterol, Claritin, Singulair, Vanceril, Zyrtec	NONE	UNK		HQ0520817JAN2000	1						1	Cough; Influenza; Pain; Pyrexia; Rhinorrhoea	FLU3~PFIZER\WYETH~4998287~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155499	06/27/2000					F	01/26/2000	A female reported that she received influenza vaccine and the next day, she developed a fever of 101F, her blood pressure increased to 198/110 and her pulse was 110. She was treated with an antibiotic and recovered within a few days. The reporter declined to provide additional information and declined to grant permission for follow-up investigation.									Y				UNK	OTH	OTH	acetaminophen, Celecoxib, Enbrel, methotrexate, Synthroid	UNK	Rheumatoid arthritis		HQ0594719JAN2000	1						1	Blood pressure increased; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155500	06/27/2000	NY				F	02/15/2000	Within 24 hours post vax, this pt developed nausea, vomiting, diarrhea and upper respiratory infection. She was seen in a ER where a dx of influenza was made. As of 02/07 the pt recovered.				Y					Y	11/23/1999	11/24/1999	1	UNK	OTH	OTH	UNK	NONE	Diabetes mellitus		HQ0714125Jan2000	1						1	Diarrhoea; Drug ineffective; Nausea; Upper respiratory tract infection; Viral infection; Vomiting	FLU3~PFIZER\WYETH~4998212~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0155501	06/27/2000	AR	44.0			F	01/27/2000	Within a few hours post vax, this pt experienced crushing chest pain. She recovered within 4-6 hours post onset of symptoms.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ0714626JAN2000	1						1	Chest pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155502	06/27/2000	TN				M	01/27/2000	Subsequent to vax, this pt developed a fever of 104-105 F, chills, body aches, cough, and nasal drainage. A dx of influenza was made, however type was not specified. This pt's children and spouse all developed influenza post receipt of 1999-2000 formula.				Y					U				UNK	OTH	OTH	UNK	UNK	UNK		HQ0741027JAN2000	1						1	Cough; Drug ineffective; Pain; Pyrexia; Rhinorrhoea; Viral infection	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0155503	06/27/2000	IL				U	02/16/2000	Subsequent to vax, this pt became sick, developed an injection site reaction characterized by swelling and stiffness.									U				UNK	PVT	OTH	UNK	UNK	UNK		HQ1063514FEB2000	1						1	Injection site oedema; Malaise; Musculoskeletal stiffness	FLU3~PFIZER\WYETH~4998263~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155504	06/27/2000	WI				F	01/26/2000	This female inadvertently received a subcutaneous injection of flu vax on 10/1/99. Later that day, she presented with injection site reaction characterized by swelling, redness, and tenderness. She recovered.									Y	10/01/1999	10/01/1999	0	UNK	PVT	PVT	UNK	UNK	UNK		HQ1780108OCT1999	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~~UNK~SC~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155505	06/27/2000	VA				F	11/03/1999	Within 45 minutes post vax, this pt developed muscle pain and soreness. Swelling developed 2 days post vax and she was seen in the ER. Physician indicated that she had had allergic reaction to possible vax additive. The pt recovered.				Y					Y	10/06/1999	10/06/1999	0	UNK	OTH	OTH	UNK	NONE	UNK		HQ1874211OCT1999	1						1	Hypersensitivity; Myalgia; Oedema	FLU3~PFIZER\WYETH~4998272~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0155506	06/27/2000	TN				U	01/27/2000	This person developed an injection site reaction post vax, characterized by redness, tenderness and hardness.									U	10/01/1999	10/01/1999	0	UNK	PVT	OTH	UNK	UNK	UNK		HQ2134312OCT1999	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain	FLU3~PFIZER\WYETH~4998273~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155507	06/27/2000	OH				F	11/15/1999	Next day post vax, the pt developed vomiting which lasted 24 hours, arm pain and arthralgia.									Y				UNK	PVT	OTH	UNK	UNK	UNK		HQ2178512OCT1999	1						1	Arthralgia; Pain; Vomiting	FLU3~PFIZER\WYETH~4998220~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0155508	06/27/2000	MI				F	11/02/1999	This physician in her 40's received vax and the following day she felt achy. Two days post vax, she felt very tired, had fever, vomiting and diarrhea and was dxed with full blown flu.				Y					U	10/08/1999	10/09/1999	1	UNK	PUB	OTH	UNK	UNK	UNK		HQ2204112OCT1999	1						1	Diarrhoea; Drug ineffective; Fatigue; Influenza; Pain; Pyrexia; Viral infection; Vomiting	FLU3~PFIZER\WYETH~4998214~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0155509	06/27/2000	NY				F	10/28/1999	Within 10 minutes post vax, this patient developed extreme pain in her arm and cried hysterically. The pt self-medicated with Benadryl and Tylenol; she self-treated with applications of ice. The pt recovered within 12 hours.									Y	10/01/1999	10/01/1999	0	UNK	OTH	OTH	UNK	UNK	UNK		HQ2288213OCT1999	1						1	Conversion disorder; Pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155510	06/27/2000	OH	5.0	5		M	11/15/1999	Twenty minutes post vax, this child became extremely agitated and his voice became very hoarse. He tried to hit himself and threatened to kill his mother. No previous history of aggressive. The next day, the aggression resolved without treatment. As of 11/01/1999, pt remains recovered.									Y	10/07/1999	10/07/1999	0	NONE	PVT	PVT	NONE	NONE	UNK		HQ2312213OCT1999	1						1	Abnormal behaviour; Aggression; Agitation; Dysphonia	FLU3~PFIZER\WYETH~4998263~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155511	06/27/2000	PA	53.0			F	11/15/1999	This employee inadvertently received an injection of improperly stored vax which had been left out of refrigeration for one day. The pt developed flu-like symptoms which consisted of a cold, aches, and diarrhea. The pt recovered.									Y				NONE	PVT	OTH	UNK	NONE	UNK		HQ2314213OCT1999	1						1	Diarrhoea; Influenza like illness; Nasopharyngitis; Pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155512	06/27/2000	TX	51.0	51		F	11/16/1999	Within hours post vax, this pt experienced 4 inch area of redness at the injection site which was also indurated, swollen, and warm.									U	10/09/1999	10/09/1999	0	UNK	OTH	PVT	UNK	UNK	UNK		HQ2354713OCT1999	1						1	Injection site hypersensitivity; Injection site mass; Injection site oedema; Vasodilation procedure	FLU3~PFIZER\WYETH~1998231~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155513	06/27/2000	TX				U	10/29/1999	Post vax, this pt developed an injection site reaction characterized by red, hard, hot knots described as the size of tennis balls.									U				UNK	PVT	OTH	UNK	NONE	UNK		HQ2466314OCT1999	1						1	Injection site hypersensitivity; Injection site mass; Vasodilation procedure	FLU3~PFIZER\WYETH~4998219~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155514	06/27/2000	GA	37.0	37		U	01/18/2000	Within 45 minutes post vax, the pt developed swelling and flushing of the face, lips and chest as well as an injection site reaction characterized by swelling and itching. The pt was administered Medrol. Within 1.5 hours, the swelling began to subside.									U	10/11/1999	10/11/1999	0	UNK	PVT	PVT	UNK	NONE	UNK		248314	1						1	Face oedema; Flushing; Injection site oedema; Pruritus; Swelling	FLU3~PFIZER\WYETH~4998218~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155515	06/27/2000	TN				U	01/18/2000	Subsequently to vax, the pt experienced an unspecified adverse event. No further information is available at time to this report.									U					PVT	OTH	UNK	UNK	UNK		HQ2544314OCT1999	1						1	Unevaluable event	FLU3~PFIZER\WYETH~1998224~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155517	06/27/2000	NY				U	11/24/1999	Post vax, this pt developed flu-like symptoms.									U	10/13/1999	10/14/1999	1	UNK	PUB	OTH	UNK	UNK	UNK		HQ2622818OCT1999	1						1	Influenza like illness	FLU3~PFIZER\WYETH~4998271~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155518	06/27/2000	PA	61.0	61		F	01/19/2000	While administering vax to pt,  the syringe disconnect and the vaccine squirted in the nurse's mouth and nostrils. At the time, she was being treated for a sinus infection with Amoxicillin. The infection  worsened within 2 days of exposure to fax and the nurse's physician increased antibiotic dosage. Physician does not correlate worsening of infection to the vax exposure.									U	10/13/1999	10/14/1999	1	UNK	OTH	OTH	Amoxicillin 250mg 3x per 1 day	Sinusitis	UNK		HQ2646118OCT1999	1						1	Condition aggravated; Sinusitis	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155519	06/27/2000	TX	77.0	77		F	10/25/1999	A couple of days post vax, this pt developed nausea and diarrhea and decreased appetite. The pt  self-medicated with Immodium without resolve. As of the date of this report, outcome is unresolved.									U	10/11/1999	10/13/1999	2	UNK	OTH	OTH	UNK	NONE	UNK		HQ2702218OCT1999	1						1	Anorexia; Diarrhoea; Nausea	FLU3~PFIZER\WYETH~~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155520	06/27/2000	CA				U	01/27/2000	Post vax, hospital employee developed cellulitis at the injection site.  The pt was treated with Keflex.									U	10/01/1999	10/11/1999	10	UNK	PVT	OTH	UNK	UNK	UNK		HQ2738118OCT1999	1						1	Cellulitis; Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155521	06/27/2000	MA				F	12/13/1999	Seven days post vax this pt developed red, blotchy fine bumps which extended from right elbow to shoulder. Several of the bumps opened and she described her right arm as feeling fatigued. The pt was seen by a physician, 10/16/99, and diagnosed with shingles. She recovered.				Y					Y	10/06/1999	10/13/1999	7	UNK	OTH	OTH	UNK	UNK	UNK		HQ2778219OCT1999	1						1	Herpes zoster; Infection; Rash vesicular	FLU3~PFIZER\WYETH~4998243~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0155523	06/27/2000	NY	74.0	74		F	01/13/2000	Same day post vax, this pt developed an exacerbation of rheumatoid arthritis with lower back pain in her feet. The prednisone therapy had been discontinued on 10/06/1999. On 12/14/99, her rheumatologist reported that the pt's back and foot pain slightly better.									U	10/06/1999	10/06/1999	0		OTH	OTH	Estrogen NOS,  Miacalcin, Prednisone Prilosec, Progesterone.	NONE	Rheumatoid arthritis		297012	1						1	Condition aggravated; Rheumatoid arthritis	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155524	06/27/2000	PA	50.0	50		M	12/03/1999	One day post vax, non-specific test for hepatitis was reportedly positive. Additional tests didn't confirm this. Most recent information indicated this was a false positive test.									U	10/13/1999	10/14/1999	1		OTH	OTH	NONE	NONE	UNK		HQ3028320OCT1999	1						1	Unevaluable event	FLU3~PFIZER\WYETH~~7+~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155525	06/27/2000	KY				M	11/15/1999	This pt developed episodes of tachycardia. It was indicated that the pt reported ongoing tachycardia and an elevated blood pressure following receipt of this vax.				Y					U	10/06/1999			Pulse - in 150's	OTH	OTH	Acetylsalicylic acid	UNK	Prostrate Cancer (NOS)		HQ3032220OCT1999	1						1	Heart rate increased; Hypertension; Tachycardia	FLU3~PFIZER\WYETH~4998269~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0155526	06/27/2000	RI	41.0	41		F	01/04/2000	A physician reported that she inadvertently received a subcutaneous injection of FLU SHIELD on 15-OCT-1999. Within 24 hours, she developed an injection site reaction characterized by redness. The patient recovered within 48 hours.									Y	10/15/1999	10/16/1999	1		PVT	OTH	None	None	Unknown		HQ3144221OCT1999	1						1	Laboratory test abnormal; Vasculitis	FLU3~PFIZER\WYETH~~UNK~SC~AR~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155527	06/27/2000	GA				F	10/28/1999	One day post vax, this pt developed a red, blotchy rash with minor soreness on  her arms and legs. The rash on her arms resolved by the end of that same day and the rash on her legs abated on the following day. She then developed swollen, sore knees.									U	10/19/1999	10/20/1999	1	UNK	OTH	OTH	UNK	NONE	UNK		HQ3174121OCT1999	1						1	Joint swelling; Pain; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155528	06/27/2000	TX	64.0	64		M	01/27/2000	One day post vax, this pt developed an injection site reaction  with redness and a black and blue bruise. He recovered.									Y	10/20/1999	10/21/1999	1	UNK	PVT	OTH	UNK	UNK	UNK		HQ3190122OCT1999	1						1	Ecchymosis; Injection site hypersensitivity; Injection site reaction	FLU3~PFIZER\WYETH~4998281~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155529	06/27/2000	OH	77.0	77		F	01/25/2000	Within one hour post vax, this pt experienced a puffy lip and loss of feeling in her lip. She was treated with 50 mg Benadryl and recovered.									Y	10/21/1999	10/21/1999	0	NONE	OTH	OTH	Epudex, salicylic acid	NONE	UNK		HQ3196222OCT1999	1						1	Hypoaesthesia; Swelling face	FLU3~PFIZER\WYETH~4998219~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155530	06/27/2000	MO	42.0	42		F	11/03/1999	Two days post vax, this pt eyes began tearing and became red, irritated, and wrinkled.									U	10/15/1999	10/17/1999	2	UNK	OTH	PVT	NONE	NONE	UNK		HQ3210222OCT1999	1						1	Eye disorder; Lacrimation increased; Ocular hyperaemia	FLU3~PFIZER\WYETH~~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155531	06/27/2000	UT	40.0	40		F	01/27/2000	Fours days post vax, this pt experienced pain at the injection site which radiated to her shoulder, back, and neck. She also experienced weakness and heaviness in her arm, causing difficulty lifting or using the arm. She recovered in 2 days without treatment.									Y	10/14/1999	10/18/1999	4	UNK	PVT	PVT	NONE	NONE	UNK		HQ3270522OCT1999	1						1	Back pain; Injection site pain; Muscular weakness; Neck pain; Sensation of heaviness	FLU3~PFIZER\WYETH~4998230~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0155532	06/27/2000	AR	50.0	50		F	01/26/2000	This pt experienced burning at the injection site during administration. Within 30 minutes, she experienced itching at the injection site, and then developed redness, swelling also but which comes and goes. She was prescribed Augmentin. Achiness at injection site ensued and radiated down her arm and up into her shoulders and neck. On 10/20, she developed flu-like symptoms of sore throat and achiness. She recovered.				Y					Y	10/14/1999	10/14/1999	0	UNK	PVT	PVT	UNK	NONE	UNK		HQ3340322OCT1999	1						1	Influenza like illness; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pain; Pharyngolaryngeal pain; Pruritus	FLU3~PFIZER\WYETH~4998287~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0133251	06/28/2000	CA	51.0	51		M	02/08/2000	This pt received vaxs on 10/27/1999. On 11/05, he developed pain in his shoulder which radiated to his neck and face. The pt was evaluated by the physician at the county health center and was prescribed NSAIDS. The pain is intermittent at this time. As of 02/03/00 he was experiencing nagging pain in left arm for over 2 months. The pain radiates up and down arm into shoulder and neck area. The pt also developed numbness in fingertip of left hand and limited mobility of the left arm too painful to have full movement. Physician seen 12/7/99 and received prescription of 500 mg Naproxen sodium for 2 weeks, which reportedly didn't help. The pain is still present.				Y					N	10/27/1999	11/05/1999	9	Labs - did not indicate problem.	PUB	PUB	lisinopril	NONE	mild hypertension		U2000000050	1						2	Hypoaesthesia; Hypokinesia; Pain; Hypoaesthesia; Hypokinesia; Neck pain; Pain	FLU3~PFIZER\WYETH~4998221~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~7258BA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4998221~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|TD~CONNAUGHT LABORATORIES~7258BA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0133900	06/28/2000	WI	57.0	57		M	12/15/1999	It was reported that a 57 year old male pt received a TD and a Flu shield vaccination on 10/25/99. Reportedly that same day, the pt experienced a local reaction of redness and swelling. The MD is stating it is cellulitis. No cultures have been performed to determine if it is a staph or strep organism. The pt was hospitalized on 10/28/99 through 10/30/99 with fever, chills and sweats. Additional information received stated that this may have been a localized reaction due to hypersensitivity and not to drug interaction. The pt's condition is improved at this point in time. A 15-day follow up report received 10/28/2002 adds: From follow-up #1 correspondence received on 04/16/2001, it was reported that the pt recovered, No problem since October 1999. From follow-up #2 correspondence received on 05/23/2001 it was reported No additional info. Pt recovered fully and is fine. Last seen winter 2001. This case is closed.  08/26/2002: During internal review of all files, it was deemed necessary to amend the report by updating the seriousness of the case from a serious labeled case to a serious unlabeled 15-Day Alert Report. This case is closed.					Y	2			N	10/25/1999	10/25/1999	0		PVT	PVT	Mavik, Hydrochlorothiazide	NONE	NONE		U199900880	1						2	Cellulitis; Hyperhidrosis; Injection site hypersensitivity; Injection site oedema; Leukopenia; Pyrexia; Cellulitis; Hyperhidrosis; Injection site hypersensitivity; Injection site oedema; Pyrexia	FLU3~PFIZER\WYETH~4998229~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~UNKNOWN MANUFACTURER~U0003BA~UNK~IM~~TD ADSORBED (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4998229~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|TTOX~CONNAUGHT LABORATORIES~U0003BA~UNK~IM~~TETANUS TOXOID, ADSORBED (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0155589	06/28/2000	NJ	61.0	61		M	06/27/2000	A physician reported that a 61 year old male received a dose of influenza virus vaccine in September, 1999. On 6/22/00 he was hospitalized. There a neurologist made a diagnosis of Guillain Barre syndrome, the pt was treated with Iv immunglobulin. The reporter indicated that he is not sure the neurologist's diagnosis is correct for Guillain Barre syndrome at this time. This report is of a serious labeled event.					Y				U	10/01/1999	06/22/2000	265	UNK	OTH	OTH	UNK	UNK	UNK	Guillain Barre Syndrome~Influenza (Seasonal) (no brand name)~~0.00~In Patient	HQ7776823JUN2000	1						1	Guillain-Barre syndrome; Guillain-Barre syndrome	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4998225~UNK~SC~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0155611	06/28/2000	WA	1.7	1	.5	F	05/05/2000	The pt experienced idiopathic thrombocytopenic purpura. This started on 3/6/00 and the pt was first seen on 3/13/00. No treatment was given.				Y					Y	02/08/2000	03/06/2000	27	plate count - 6000	PVT	PUB	NONE	diarrhea	NONE			1						1	Thrombocytopenia; Thrombocytopenic purpura	DTAP~SMITHKLINE BEECHAM~913A2~4~IM~RL~DTAP (INFANRIX)~1|FLU3~CONNAUGHT LABORATORIES~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~PFIZER\WYETH~530453A~3~IM~LL~HIB (HIBTITER)~1|IPV~CONNAUGHT LTD.~P0167~3~SC~LA~POLIO VIRUS, INACT. (POLIOVAX)~1	USA	Emergency room visit	Influenza
0155650	06/28/2000	SC	59.0	59		F	11/01/1999	On 10/8/99, the pt's right deltoid and right upper inner arm was red with a whelp. The symptoms persisted for seven days. Treated with Claritan.									Y	10/08/1999	10/08/1999	0		PVT	PVT	Effexor, Flavix	NONE	stroke, polydipsia		U1999008130	1						1	Injection site hypersensitivity	FLU3~PFIZER\WYETH~4998223~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HIBV~CONNAUGHT LABORATORIES~~UNK~IM~RA~HIB (ACTHIB)~1|TD~CONNAUGHT LABORATORIES~U0003BA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0155782	06/29/2000	PA	2.0	2	.2	M	06/19/2000	The pt experienced a chickenpox rash.									Y	10/18/1996	06/19/2000	1340		PVT	PVT		NONE	NONE			1						1	Drug ineffective; Infection	FLU3~PARKDALE PHARMACEUTICALS~00176P~5~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|VARCEL~MERCK & CO. INC.~0837D~1~SC~~VARICELLA (VARIVAX)~1	USA		Influenza
0155850	06/30/2000	NJ	52.0	52		F	05/07/2002	Approximately 2 weeks post vax, the pt developed severe flu infection, intestinal and heart problems. The pt was hospitalized 3 times, been to ER, and seen 14 different doctors. The pt is still having intense pain and is unable to work. Upon review of this case on 07/07/00, it was determined that the COSTART coding of pain needed to be added to this report. Follow-up 05/03/02. During internal auditing of all files, it was deemed necessary to amend the report by coding additional A5x.				Y					N	10/01/1998				UNK	UNK					U200000501	1						1	Cardiac disorder; Gastrointestinal disorder; Influenza; Pain	FLU3~CONNAUGHT LABORATORIES~0977180~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0155888	07/03/2000	FL				F	06/29/2000	Pt received flu vax on 11/29/99. The pt was receiving weekly methotrexate to treat rheumatoid arthritis at the time of immunization. She became ill on 12/3/99. On 12/7/99, she was seen by her physician and hospitalized in the ICU. She required mechanical ventilator on 12/12/99. The pt died on 1/6/00. The treating physicians reportedly attributed this event to the methotrexate therapy. The husband attributed this event to an interaction between the flu vax and methotrexate. On Follow-up pt had a history of Parkinsonism. Medical records were recieved on 7/12/00. The pt had increasing shortness of breath and fatigue for months prior to hospitalization. On 12/7/99, she was hospitalized because of fatigue, shortness of breath, nausea, and possible low-grade fever. Medical history included allergies to metoclopramide, ibuprofen, and salsalate. During hospitalization, her rheumatoid factor was positive; ANA titer was negative, ESR was 106mm/hr. Chest x-ray revealed severe bilateral parenchymal disease since December 12, 1999. Follow up info was received from a medical center on 8/17/00, 9/28, and 10/25/00.The pt is a non-smoker and abstains from alcohohl. She has a past hisotry of bilateral silicone breast implant with subsequent removal, partial vaginal hysterectomy, tubal ligation. She also had problems with occasional choking and gasping while eating and drinking, though no recent episodes of aspiration were reported. the pt's medical history includes a recent treatment with Mirapex and requip, which were discontinued due to intolerance. Therapy with Methotrexate 15mg weekly for rheumatoid arthritis began in 1997 and ceased after 12/5/99. The pt received her 1999-2000 formula influenza virus vaccine on 11/29/99, approximately 14 hrs afte her methotrexate dose. A chest x-ray revealed bialteral infiltrates with the greatest concentration int he left perihilar and righ tupper lobe region. The differential diagnosis at this time included congestive heart failure, aspiration, connective tissue disease, drug reaction, atypical community acquired pneumonia, and other atypical infections. Immunosuppresive therapy, including methotrexate, was withdrawn. A bronchoscopy examination on 12/10/99 was unremarkable; however, microscopic analysis of pooled bronchoalveolar levage revealed acute and chronic inflammation with rare atypical squamous and bronchial epithelial cells. Bronchial lavage cultures were negative. The pt was inturbated and ventilated on 12/12/99. A chest x-ray on 12/13/99, revealed progressive RUL infiltrate with no improvement in severe bilateral lparenchymal disease compared to 12/12/99. The pt was also treated with piperacillin/tazobactam and imipenem/cilastatin. Additional therapy included furosemide, propofol and lorazempam. Physical examination on 12/13/99 revealed lungs iwth bialteral rhonchi and rales. A chest x-ray on 12/15/99 revealed significant improvement since 12/14. Lab test results in December 1999 included: rheumatoid factor, positive; ANA negaitve; and ESR 106. Based on these lab results and the fact that the pt remained afebrile, the neurologist suggested htat an autoimmune process should be considered. ON 12/10/99, C-ANCA and P-ANCA were both negtive. The pt's WBC count rose steadily from 14,400 cells/mm^3 on 12/10/99 to 40,700 cells/mm^3 on 1/6/00. Amantadine was discontinued due to the pt's fatigue. Findings during a lung biopsy on 12/21/99 were a severely diffuse process with ver friable weak lung prenchyma incapable of holding either stapling devices and/or sutures. The lung was extremely abnormal and did not appear to be ventilating or aerating well. Microscopic analysis revealed rapidly progressive diffuse alveolar damage considdtent with acute interstitial pneumonitis of unknown etiology. The abnormalities were temporally uniform and reflected an episode of massive acute lung injury occurring at a single point in time. The pt continued to have a persisitent broncho-alveolar fistula following thoracic surgery. Cultures of lung tissue were negative for bacteria, virus and fungi. Blood cultures on 12/20/99 were positive for coagulase-negative Staphylococci and sputum cultures were positive for presumptive Candida albicans. A sputum culture on 1/4/00 was positive for P. seruginosa. A PPD performed during the hospital stay was negative. On 12/23/99, a chest x-ray revealed a small apical pneumothorax and development of what appeared tobe pneumopericardium and neumomediastinum since 12/22/99, with persistent bilateral pulmonary densities consistent with severe pulmonary edema. The impression was that ARDS was a consideration. Corticosteroid therapy with subsequently initiated. The consumer reported that the pt had lost 50% of her then reduced lung capacity and she required an increase in her oxygen from 60% to 100% and requiring paralyzing drugs. A chest x-ray on 1/6/00 revealed a reduced right apical pneumothorax with dense infiltrates bilaterally. There appeared to be increase in air within the right basilar pleural space compared to prior film. Subcutaneous emphysema is increased in the right axillary region. She died on 1/6/00, from respiratory failure secondary to acute interstitial penumonitis. The consumer reported that the event was a result of a compromised immune system, which the consumer felt was exacerbated by the influenza virus vaccine. The pulmonologist confirmed the pneumonitis, but due to its uncertain etiology, could not confirm that the pt had pneumonia. Further medical records recieved on 9/28/00, provided additional medical history of bone mass decreased (osteopenia), gastro-oesophageal reflux disease; los of balance resulting in falls, and headaches NOS. Medications included /Relafen, Sinemet. On 12/7/99, the pt's flu-like illness included scratchy, then sore throat, cough and chills. Hematology results on 12/7/99,included WBC and absolute neutrophil count which rose from 7.3 x 10^3 and 6.12 x 10^3 respectively, to 12.4 x 10^3 and 10.68 x 10^3 on 12/9/99. Seurm osmolarity was 253 and potassium was 2.4 on 12/7/99. Lab test results on 12/8/99 were creatinine 0.4; sodium 125; and chloride 94. Blood, pleural fluid, and urine cultures were negative. A chet x-ray on 12/7/99, revealed a dense upper lobe consolidation (lung infiltration NOS) with focal areas at the right base and mid-lung. A chest x-ray on 12/9/99 revealed worsening bialteral air-space consistent with pneumonia, pulmonary hemorrhage, or atypical pulmonary edema. A CT scan of the chest showed a predominatly alveolar process with marked areas of consolitation involving the lungs bilaterally; a moderately large right-sided pleural effusion; right lobe volume loss; and atherosclerotic aortic disease. An abdominal x-ray on 12/8/99 was suggestive of ileus. Her diagnosis at this time was RUL infiltrate and pleural effision, thought to be secondary to aspiration. She also had ileus and hyponatremia secondary to SIADH, both considered secondary to the pulmonary proces. The pt also had increased lower extremity weakness. (Reference methotrexate case number HQ7226113JUN2000).	Y	01/06/2000		Y	Y	31			N	11/29/1999	12/03/1999	4	open lung biopsy-acute interstitial pneumonitis. A bronchoscopy examination on 12/10/99 was unremarkabl; however, microscopic analysis of pooled bronchoalveolar levage revealed acute and chronic inflammation with rare atypical squamous and bronchial epithelial cells. Bronchial lavage cultures were negative. A chest x-ray on 12/13/99, revealed progressive RUL infiltrate with no improvement in severe bilateral lparenchymal disease compared to 12/12/99. A chest x-ray on 12/15/99 revealed significant improvement since 12/14. Lab test results in December 1999 included: rheumatoid factor, positive; ANA negaitve; and ESR 106. Based on these lab results and the fact that the pt remained afebrile, the neurologist suggested htat an autoimmune process should be considered. ON 12/10/99, C-ANCA and P-ANCA were both negtive. The pt's WBC count rose steadily from 14,400 cells/mm^3 on 12/10/99 to 40,700 cells/mm^3 on 1/6/00. . Findings during a lung biopsy on 12/21/99 were a severely diffuse process with ver friable weak lung prenchyma incapable of holding either stapling devices and/or sutures. Cultures of lung tissue were negative for bacteria, virus and fungi. Blood cultures on 12/20/99 were positive for coagulase-negative Staphylococci and sputum cultures were positive for presumptive Candida albicans. A sputum culture on 1/4/00 was positive for P. seruginosa. A PPD performed during the hospital stay was negative. On 12/23/99, a chest x-ray revealed a small apical pneumothorax and development of what appeared tobe pneumopericardium and neumomediastinum since 12/22/99, with persistent bilateral pulmonary densities consistent with severe pulmonary edema. Hematology results on 12/7/99,included WBC and absolute neutrophil count which rose from 7.3 x 10^3 and 6.12 x 10^3 respectively, to 12.4 x 10^3 and 10.68 x 10^3 on 12/9/99. Seurm osmolarity was 253 and potassium was 2.4 on 12/7/99. Lab test results on 12/8/99 were creatinine 0.4; sodium 125; and chloride 94. Blood, pleural fluid, and urine cultures were negative. A chet x-ray on 12/7/99, revealed a dense upper lobe consolidation (lung infiltration NOS) with focal areas at the right base and mid-lung. A chest x-ray on 12/9/99 revealed worsening bialteral air-space consistent with pneumonia, pulmonary hemorrhage, or atypical pulmonary edema. A CT scan of the chest showed a predominatly alveolar process with marked areas of consolitation involving the lungs bilaterally; a moderately large right-sided pleural effusion; right lobe volume loss; and atherosclerotic aortic disease. An abdominal x-ray on 12/8/99 was suggestive of ileus.	MIL	MIL	Methotrexate tablet, amantadine, calcium	UNK	arthritis, parkinsonism, blepharitis, drug hypersensitivity		HQ7946728JUN2000	1						1	Dyspnoea; Fatigue; Hypoxia; Nausea; Pneumonitis; Pyrexia; Rheumatoid factor	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0156062	07/05/2000	MS	36.0	35		M	06/19/2000	Pt experienced pain in right shoulder since 3/1/00. Pt has had pains since then. Seen in Internal Medicine department on 5/15/00. Referred for an MRI.									U	02/06/2000	03/01/2000	24	lab test - neg	MIL	MIL	Clonodine	Hypertension				1						1	Arthralgia	FLU3~CONNAUGHT LABORATORIES~0970170~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|YF~CONNAUGHT LABORATORIES~7347AD~UNK~IM~~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0155241	07/06/2000	MD	53.0	53		M	07/03/2000	On 1/27/00, the pt developed myalgia in his calf muscles. In February 2000, he had difficulty walking steps and weakness in his legs. The reporter also indicated that on 3/10/00, the pt was disabled. He was seen by a neurologist and internist and admitted to a tertiary care facility on 3/17/00. There, dx of Guillain Barre syndrome, coronary heart disease, and sarcoidosis were made. On 4/30/00, he was discharged.   Follow-up information received on 7/24/00 indicated that the pt was not dx with coronary heart disease and was given a possible dx of sarcoidosis for which he is being treated with prednisone daily. The dx of Guillain Barre syndrome was ruled out, he was eventually dx with chronic inflammatory demyelinating polyneuropathy. As relayed by the reporter, the pt stated that he has been given a 90% chance of full recovery within one year.					Y	18			U	12/22/1999	03/17/2000	86	MRI, LP	PUB	PUB	NONE	NONE	UNK		HQ8030829JUN2000	1						2	Cardiac failure congestive; Difficulty in walking; Muscular weakness; Myalgia; Neuropathy; Sarcoidosis; Demyelination; Difficulty in walking; Muscular weakness; Myalgia; Demyelination; Difficulty in walking; Guillain-Barre syndrome; Muscular weakness; Myalgia; Sarcoidosis	FLU3~PFIZER\WYETH~4998249~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEPA~SMITHKLINE BEECHAM~639B6~1~IM~LA~HEP A (HAVRIX)~1|FLU3~PFIZER\WYETH~4998249~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|HEPA~SMITHKLINE BEECHAM~639B6~1~IM~LA~HEP A (HAVRIX)~2|FLU3~PFIZER\WYETH~4998249~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~3|HEPA~SMITHKLINE BEECHAM~639D6~1~IM~LA~HEP A (HAVRIX)~3	USA	Hospitalisation	Influenza
0156094	07/06/2000	CA	40.0	39		F	06/28/2000	Pt experienced lethargy, general body aches, malaise, stomach pain, missed one day of work.									Y	03/20/2000	03/22/2000	2	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Abdominal pain upper; Lethargy; Malaise; Pain	FLU3~CONNAUGHT LABORATORIES~U0169AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~CONNAUGHT LABORATORIES~UA160AA~2~SC~~MENINGOCOCCAL (MENOMUNE)~1	USA		Influenza
0155241	07/07/2000	MD	53.0	53		M	07/06/2000	On 1/27/00, the pt experienced myalgia in his calf muscles. In February 2000, he found it difficult to take steps and had weakness in his legs. He was disabled from 5/10/00. A neurologist was consulted, and the vaccinee was admitted to the hospital from 3/17/00 to 4/3/00. Dx with Guillain-Barre Syndrome, coronary heart disease, and sarcoidosis.  Follow-up information received 7/31/00 states that the adverse event occurred 15 days after returning from a trip to the Phillippines. He was disabled and unable to work as an electrician. It also states that when he was hospitalized, he had no use of his legs and a diagnosis of chronic inflammatory demyelinating polyneuropathy and possible sarcoidosis was made. On rule out, the internists ascribed his symptoms to the flu shot he had had in December. According to the pt, he has been given a 90% chance of full recovery within one year. At present, his physician is suspecting that the pt has sarcoidosis, which he relates can mimic the above symptoms. The pt was receiving prednisone. The most recent information reports the outcome of the event as improving.				Y	Y	18		Y	N	12/22/1999	01/27/2000	36	MRI, LP-results pending	PUB	PUB	medicine to control acidity		NONE		20000201011	1						3	Cardiac failure congestive; Difficulty in walking; Muscular weakness; Myalgia; Neuropathy; Sarcoidosis; Demyelination; Difficulty in walking; Muscular weakness; Myalgia; Demyelination; Difficulty in walking; Guillain-Barre syndrome; Muscular weakness; Myalgia; Sarcoidosis	FLU3~PFIZER\WYETH~4998249~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEPA~SMITHKLINE BEECHAM~639B6~1~IM~LA~HEP A (HAVRIX)~1|FLU3~PFIZER\WYETH~4998249~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|HEPA~SMITHKLINE BEECHAM~639B6~1~IM~LA~HEP A (HAVRIX)~2|FLU3~PFIZER\WYETH~4998249~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~3|HEPA~SMITHKLINE BEECHAM~639D6~1~IM~LA~HEP A (HAVRIX)~3	USA	Hospitalisation,Disabling	Influenza
0155589	07/07/2000	NJ	61.0	61		M	07/05/2000	A physician reported that a 61 year old male, inadvertently, received a SC injection of Flu Shield (1999-2000) on 10/1/99. On 6/22/00, he was hospitalized. There, a neurologist made a dx of Guillain Barre Syndrome; the pt was treated with IV immunglobulin. Eight days later, the pt was discharged; he recovered. The reporter indicated that he is not sure the neurologist's dx is correct for Guillain Barre Syndrome at this time. follow-up received 05/01/2002, from physician. On 07/13/2000, the pt died GBS was noted as probable  cause of death along with hypertension and mixed hyperlipidemia.					Y	8			Y	10/01/1999	06/22/2000	265	NONE	OTH	OTH	Oral anti-hypertensives per reporter	UNK	UNK		HQ7776823JUN2000	1						2	Guillain-Barre syndrome; Guillain-Barre syndrome	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4998225~UNK~SC~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0163233	07/10/2000	NY	17.0			M	07/10/2000	One day post vax the pt developed a fever of 101F. Three days post vax the pt developed a grapefruit sized welt at the injection site and was treated with oral and topical diphenhydramine and applications of ice. He recovered. A copy of this report has been forwarded to Merck, the manufacturer of Pneumovax.									Y	01/26/2000	01/27/2000	1	UNK	PVT	OTH	UNK	UNK	UNK		HQ6162419MAY2000	1						1	Injection site reaction; Pyrexia; Urticaria	FLU3~PFIZER\WYETH~4998261~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1482J~UNK~IM~RL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0156451	07/13/2000	WI	2.9	2	.9	F	05/16/2000	Subsequent to receiving varicella virus vaccine live the pt experienced chickenpox with  100 lesions noted. Pt was afebrile on day 1 of the illness. A titer was checked on day 2 of the illness and it was noted to be 3.6, 4X the titer needed for protection. Information from physician indicated typical papules and small vesicles on an erythematous base each no larger than 3mm in diameter with the base being no larger than 8 mm in diameter. They are scattered discretely about the face including the right lower eyelid margin, a few scattered on the trunk and on each extremity.				Y					Y	10/18/1995	11/04/1999	1478	varicella antibody titer 11/05/1999 4X titer needed for protection chickenpox confirmed by analysis of the virus 11/05/1999	PVT	PVT			UNK		WAES99111454	1						1	Drug ineffective; Infection	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~0439B~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0157359	07/19/2000	IL	20.0			F	04/24/2000	A physician reported that his 20 year old daughter received Flu Shield on 11/5/99 and subsequently developed an acute central nervous system demyelinating disorder manifested by marked tremors of her extremities and body, as well as prominent cerebellar signs including marked gait disturbance. She was hospitalized					Y				U	11/05/1999			UNK	OTH	OTH	UNK	UNK	UNK		HQ1787923MAR2000	1						1	Demyelination; Gait disturbance; Nervous system disorder; Tremor	FLU3~PFIZER\WYETH~4998275~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0157376	07/19/2000	AK	24.0	24		F	07/07/2000	The pt experienced headaches, nausea, vomiting, chest pains, dehydration requiring IV hydration.				Y					U	10/12/1999	10/22/1999	10	TSH, ANA, ESR, RF, WNL	MIL	UNK	Tri-Levlin		positive ppd			1						1	Chest pain; Dehydration; Headache; Nausea; Vomiting	ANTH~MICHIGAN DEPT PUB HLTH~~4~SC~~ANTHRAX (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4998235~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0157382	07/19/2000	MD	60.0	60		F	06/09/2000	Pt experienced headaches, eye movement pain and congestion. Symptoms began approximately 2 weeks post vax and continued as of the time of this report. Pt was treated with Bactrim, Medrol, Tylenol, Sudafed.				Y					N	11/19/1999	12/05/1999	16	CT Scan - normal; blood tests - normal; Brain MRI showed inflammation of the meninges; spinal tap - normal; blood test for Lyme disease - normal; eye tests normal	PUB	UNK	Dilacor; Pepcid; Primivil	NONE	hypertension; acid reflux			1						1	Eye pain; Headache; Nasal congestion; Eye pain; Headache; Laboratory test abnormal; Meningitis; Nasal congestion; Eye pain; Headache; Meningitis; Nasal congestion	FLU3~PARKDALE PHARMACEUTICALS~01989P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~01989P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2|FLU3~PARKDALE PHARMACEUTICALS~01989P~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUOGEN)~3	USA	Emergency room visit	Influenza
0117839	07/20/2000	MD	41.0	41		F	05/05/2000	Subsequent to receiving vax pt experienced difficulty breathing, itching and a swollen face. The itching appeared 48 hours post vax with the breathing difficulties occurring 5 days post vax. On the 6th day post vax the pt woke up with a swollen face. The pt took homeopathic antihistamine during the 4th - 6th days post vax and Benadryl at night. By the 7th day the breathing difficulties had resolved and the itching and swelling were getting better. The pt has been advised not to have the influenza vaccine again.									Y	10/26/1998	10/28/1998	2		PUB	PUB	NONE		allergic to latex; seasonal allergies		MPI1999001290	1						2	Dyspnoea; Face oedema; Pruritus	FLU3~MEDEVA PHARMA, LTD.~E20148HE~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0131552	07/20/2000	CA	39.0	38		M	11/23/1999	p/vax pt w/1/4 blister formation @ site of inj;otherwise asymptomatic;requested client to come to clinic for further eval; Per HCP follow up report- spoke with patient 11/18/99 at 6pm about prescence of blister formation-exact onset time not noted.									U	11/15/1999			NA	UNK	UNK	NONE	NONE	NONE			1						1	Injection site hypersensitivity; Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~U0133AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0133AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0131552	07/20/2000	CA	39.0	38		M	11/23/1999	p/vax pt w/1/4 blister formation @ site of inj;otherwise asymptomatic;requested client to come to clinic for further eval; Per HCP follow up report- spoke with patient 11/18/99 at 6pm about prescence of blister formation-exact onset time not noted.									U	11/15/1999			NA	UNK	UNK	NONE	NONE	NONE			1						2	Injection site hypersensitivity; Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~U0133AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0133AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0132968	07/20/2000	CA	48.0	48		M	02/25/2000	Pt experienced a generalized macular confluent rash affecting his entire back with a fever of100.4 5 minutes post vax. Pt was diagnosed  with an allergy to influenza vaccine and treated with Benadryl. The pt was previously immunized 16 times for influenza with no adverse effects.				Y					Y	10/28/1999	10/28/1999	0		PUB	PUB	NONE		Profound mental retardation; diaper rash; folliculitis; constipation; allergic to diiodoquin; acne on  back; mild acne vulgaria		MPU200000005	1						2	Pyrexia; Rash macular	FLU3~MEDEVA PHARMA, LTD.~E26919HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0157587	07/20/2000		45.0	45		M	05/08/2000	25 days post vax pt experienced lid edema and urticaria (upper arms, chest, shoulder). The duration of the symptoms are stated as 3 months. Treatment consisted of Lisino Apis D30 and Sulfur D30 but without lasting effect. After Influenza C30 was administered 01/21/1999 the symptoms increased then completely abated. It is also stated that 2 weeks post vax severe herpes labialis occurred along with lid edema and nettles which increased with cold and sleep, with intense.									Y	10/06/1998	11/01/1998	26		OTH	OTH	NONE		recurring frontal sinusitis		REG1999001530	1						1	Eyelid oedema; Herpes simplex; Urticaria	FLUX~UNKNOWN MANUFACTURER~E81021AC1~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0157588	07/20/2000		68.0			M	05/08/2000	Pt experienced generalized muscle aches after receiving vax. Pt still has complaints in both shoulders. He is concerned about taking vaccine.									N	11/05/1998				OTH	OTH	Glibenclamide; atenolol; diclofenac				REG1999001650	1						1	Myalgia	FLU3~MEDEVA PHARMA, LTD.~E81024CA1~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0157589	07/20/2000	WA	50.0			M	05/05/2000	2 weeks post vax the pt experienced arthritis pain in his elbow, hip, ankle and knees for a duration of 4 months. Pt is now feeling better, however, his elbow still hurts. The pt has questioned the use of sequaline in flu.									N	10/21/1998	11/04/1998	14		OTH	OTH	NONE				MPI1999001680	1						1	Arthritis; Pain	FLU3~MEDEVA PHARMA, LTD.~E20248KC~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0157590	07/20/2000		73.0			F	05/05/2000	Pt experienced phlegm build up in the laryngeal area after receiving Fluvirin and Pneumovax vax. The pt is currently seeing a speech therapist due to the phlegm build up. The pt has told her GP that the problem dated from 10/1997, when she received the vax.									N	10/01/1997	10/01/1997	0		OTH	OTH	NONE				MPU1999002000	1						1	Nasal congestion	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0157591	07/20/2000		78.0	78		F	05/08/2000	After receiving vax pt experienced polymyalgia rheumatica. Pt is recovering after treatment. The reaction has been described as progressive myalgia which became localized to peMC and shoulder girdles. Pt was treated with prednisone.									N	10/29/1998			erythrocyte sedimentation rate 96 mm/hr	OTH	OTH	NONE				REG1999002190	1						1	Polymyalgia rheumatica; Red blood cell sedimentation rate increased	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0157593	07/20/2000		37.0	37		M	05/05/2000	Pt 055 in clinical study MPL318-01 with a history of hemorrhoids had a preplanned hemorrhoidectomy 1week and 4 days post vax. The pt was being treated with Tri-Adcortyl until the day of surgery. The vaccinee was hospitalized for 1 day. The procedure was performed under anesthesia and the pt was prescribed unspecified pain killers for post operative pain relief. In addition he was given Lactulose and Fybogel. The event is now considered to be resolved. The investigator considered the event to be moderate and unrelated to study medication. The Medical Reviewer also considered the event to be unrelated.					Y	1			Y	07/01/1999	07/13/1999	12		OTH	OTH	NONE		cefaclor allergy		MOU1999002490	1						1	Haemorrhoids	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0157594	07/20/2000	IN	49.0			F	05/05/2000	Pt received Pnu-Imune 23 and Fluvirin on the same day into the right deltoid. Within 24 hours post vax the pt developed a fever of 104F which persisted for several days then decreased to 102F. She was afebrile as of 10/01/1998, but had a cough productive for white sputum and had chest congestion. It is recommended that these two vaccines be injected into separate sites when they are administered concomitantly. Follow up information information indicated that the vaccinee had a history of small cell lung adenocarcinoma which was treated with Taxol and carboplatin. Pt was treated with Tylenol which relieved her symptoms of fever, chest congestion and productive cough. The fever resolved after 48 hours and all symptoms are stated as having resolved 4 days post onset. Reporting physician strongly believes that the pts reaction may be related to injection of influenza and pneumo vax simultaneously.									Y		09/25/1998			PVT	PVT	carboplatin; Taxol		non small cell lung adenocarcinoma		MPU19990037	1						1	Cough; Nasal congestion; Productive cough; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E20176HB~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~454976~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0157595	07/20/2000	TX	52.0	52		F	05/05/2000	A few hours post vax the pt developed hives mostly on the arms, and was itching all over. Pt was seen by a physician and Benadryl tablets were prescribed. The outcome of the event was not reported. Additional detail indicated that the pt had hives; red, raised on wrists, forearm and one side of neck. The pt denied shortness of breath or difficulty breathing. Symptoms resolved after two days.									Y	09/20/1999	09/20/1999	0		OTH	OTH	NONE				MPU1999003850	1						1	Pruritus; Rash erythematous; Urticaria	FLU3~MEDEVA PHARMA, LTD.~H26909HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0157596	07/20/2000	TX	36.0	36		F	05/05/2000	Five hours post vax the pt experienced itching all over. The vaccinee was treated with Benadryl. The outcome was not reported. Follow up information indicates that the symptoms resolved within 3 days.									Y	09/20/1999	09/20/1999	0		OTH	OTH	NONE				MPU1999003860	1						1	Pruritus	FLU3~MEDEVA PHARMA, LTD.~E26909HA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0157597	07/20/2000	TX	52.0	52		M	05/05/2000	Pt experienced itching the the afternoon post vax. The following day he received an IM shot of Benadryl. The pts reaction resolved one and a half days post vax.									Y	09/20/1999	09/20/1999	0		OTH	OTH	NONE				MPU1999003870	1						1	Pruritus	FLU3~MEDEVA PHARMA, LTD.~E26909HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0157598	07/20/2000	TX	47.0	47		M	05/05/2000	Two hours post vax pt experienced general malaise, enlarged lymph nodes under his chin and difficulty swallowing. Pt was treated with Benadryl IM and taken to the ER where he was treated with an unspecified medication. the reporter states that the vaccinee denied and difficulty breathing or swallowing, his lungs were clear and no complaints of nausea or vomiting; heart rate was 80 bpm. The vaccinee stated he had a rash at the injection site. 10 minutes after the initial onset pts blood pressure was 120/80 and heart rate  60 bpm. 10 minutes later vaccinee complained of difficulty swallowing and felt like it was getting worse the pt was given Benadryl IM. the vaccinee was seen by a physician who noted that his throat had redness and swelling. He was taken to the ER where he was treated with an unspecified medication. The vaccinee was followed up with 3.5 hours later when he was reported to be back at work and feeling okay. The vaccinee stated that something like this happened last year after vax.				Y					Y	10/07/1999	10/07/1999	0		OTH	OTH	cholesterol medication				MPU1999004190	1						1	Dysphagia; Erythema; Injection site rash; Lymphadenopathy; Malaise; Pharyngeal oedema; Vaccine positive rechallenge	FLU3~MEDEVA PHARMA, LTD.~E24B669GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0157599	07/20/2000	OK	48.0	48		F	05/05/2000	Approximately 8.5 hours post vax the pt experienced severe deep tendon muscle pain. At 7PM pt took Biox tablet for backache. At 10PM she noticed muscle cramps on the inside of thighs which was relieved with movement. Half and hour later she was awakened by severe deep tendon pain which ran from the outside calf from ankle to knee and then up inside her thighs to her groin. She states that she was screaming and crying and could not relax. Her husband, an MD, tried to massage her muscles and the report states that he couldn't feel any spasms. The pt was inconsolable and her physician husband administered and unspecified amount of IV Valium. She woke up feeling fine. No further muscle cramps or complaints of discomfort. Pt is cold by nature and experienced an unusual feeling of extreme heat during this event.									Y	10/14/1999	10/14/1999	0		OTH	OTH	NONE		seasonal allergies; allergic to erythromycin, tetanus, Noroxin		MPU1999004490	1						1	Agitation; Back pain; Groin pain; Muscle spasms; Myalgia	FLU3~MEDEVA PHARMA, LTD.~E24809GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0157600	07/20/2000	NJ	63.0			F	05/05/2000	2 days post vax the pt experienced pain and redness at injection site. Pt was advised to treat with an ice pack and Tylenol. 5 days post vax the injection remains red but is no longer painful.									N	10/13/1999	10/15/1999	2		OTH	OTH	metoprolol; hydrochlorothinzide		osteoarthritis		MPU1999004510	1						1	Injection site erythema; Injection site pain	FLU3~MEDEVA PHARMA, LTD.~E26909HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0157601	07/20/2000	NJ	45.0	45		F	05/05/2000	One day post vax pt experienced pain, slight swelling and redness at injection site. Follow up information indicates the she developed a lump the size of a golf ball which was red in color and very painful. Pt has had many influenza vaccine in the past and never experience and reaction.									N	10/18/1999	10/19/1999	1		OTH	OTH	NONE		lactose intolerance and irritable bowel		MPU1999004520	1						1	Injection site erythema; Injection site mass; Injection site oedema; Injection site pain	FLU3~MEDEVA PHARMA, LTD.~H26909HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0157602	07/20/2000	NJ	64.0	66		F	05/05/2000	One day post vax the pt experienced redness and heat at the injection site (4 inch circumference). Pt refused treatment and the event was ongoing.									N	10/18/1999	10/19/1999	1		OTH	OTH	Premarin; Synthroid; Zantac; Zocor		Allergic to PCN, Ceclor, Sulfa, Bentyl, Mevacore		MPU1999004530	1						1	Injection site erythema; Injection site warmth	FLU3~MEDEVA PHARMA, LTD.~E26909HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0157606	07/20/2000					F	05/05/2000	Pt received an expired dose of Fluvirin vaccine and experienced chills, low grade fever, achiness and headache, within 24 hours post vax. Symptoms resolved quickly.									Y	10/14/1999	10/15/1999	1		OTH	OTH	NONE		Had previous vaccination with no problems.		MPU1999004580	1						1	Headache; Pain; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0157607	07/20/2000	NJ	51.0	51		F	05/05/2000	Immediately following vaccination, pt experienced itching in her whole arm. Within hours, a 4 diameter area at the injection site became red, hard, hot and itchy. Pt treated with hydrocortisone for itching. The on duty nurse described the area as induration with redness.									N	10/21/1999	10/21/1999	0		OTH	OTH	NONE				MPU1999004610	1						1	Injection site erythema; Injection site induration; Injection site warmth; Pruritus	FLU3~MEDEVA PHARMA, LTD.~E26909HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0157610	07/20/2000	MI	44.0	44		F	05/05/2000	Pt experienced an area at the injection site which was swollen, red and hot to the touch, the same evening as receiving vaccination. The afflicted area was the size of a tennis ball. The arm was very sore and felt extremely heavy. The swelling lasted for 5 days but symptoms decreased daily. The stiffness lasted for 2-3 days. Pt states she received an influenza vax in 1998 without incident.									Y	10/26/1999	10/26/1999	0		OTH	OTH	vitamin E; Premarin; Accupril; Microzide; Calcium		hypertension		MPU1999004970	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Musculoskeletal stiffness; Sensation of heaviness	FLU3~MEDEVA PHARMA, LTD.~E27989HA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0157611	07/20/2000	MI				U	05/05/2000	Pt experienced a fairly significant local reaction, described as firm, warm, erythematous area measuring from 60-80 mm in diameter. Pt's symptoms resolved, time to onset and duration not reported.									Y	10/01/1999	10/01/1999	0		OTH	OTH	NONE				MPU1999004980	1						1	Injection site erythema; Injection site induration; Injection site warmth	FLU3~MEDEVA PHARMA, LTD.~E27989HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0157612	07/20/2000	MI				U	05/05/2000	Pt experienced fairly significant local reaction described as firm, warm, erythematous area measuring from 60 to 80 mm in diameter. Symptoms resolved, time of onset and duration not reported.									Y	10/01/1999	10/01/1999	0		OTH	OTH	NONE				MPU1999004990	1						1	Injection site erythema; Injection site induration; Injection site warmth	FLU3~MEDEVA PHARMA, LTD.~E27989HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0157613	07/20/2000	MI				U	05/05/2000	Pt experienced a firm, warm, erythematous area measuring 60 - 80 mm in diameter local to injection site.									Y	10/01/1999				OTH	OTH	NONE				MPU1999005000	1						1	Feeling hot; Injection site hypersensitivity	FLU3~MEDEVA PHARMA, LTD.~E27989HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0157614	07/20/2000	MI				U	05/05/2000	Pt experienced a firm, warm, erythematous area measuring 60 - 80 mm in diameter local to injection site.									Y	10/01/1999				OTH	OTH	NONE				MPU1999005010	1						1	Feeling hot; Injection site hypersensitivity	FLU3~MEDEVA PHARMA, LTD.~E27989HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0157615	07/20/2000	MI				U	05/05/2000	Pt experienced a firm, warm, erythematous area measuring 60 - 80 mm in diameter local to injection site.									Y	10/01/1999				OTH	OTH	NONE				MPU1999005020	1						1	Feeling hot; Injection site hypersensitivity	FLU3~MEDEVA PHARMA, LTD.~E27989HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0157616	07/20/2000	TN				F	05/05/2000	2 hours post vax the pt experienced a 5 cm rash at the injection site. Pt was treated with Benadryl.									N	11/01/1999				OTH	OTH	NONE				MPU1999005030	1						1	Injection site rash	FLU3~MEDEVA PHARMA, LTD.~E26119HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0157621	07/20/2000	LA	3.4	3		F	05/05/2000	4 days post vax the pt developed viral respiratory symptoms treated with Hydrocodone nitrate, Tylenol and Motrin. Symptoms resolved 12 days post onset. The following day pt returned to the clinic complaining of conjunctivitis and a persistent cough. 19 days post vax, the pt developed a fever and cough with shaking chills and 20 days post vax pt was diagnosed with pneumonia. Pt was hospitalized the following day and on admission a chest x-ray revealed peribronchial thickening in perihilar regions which was compatible with tracheobronchitis. Pt was treated for presumptive bacterial pneumonia in hospital . The event resolved after 18 days.					Y	2			Y	10/26/1999	11/15/1999	20	x-ray revealed peribronchial thickening in perihilar regions which was compatible with tracheobronchitis; Rhonchi and rales left lower lobe especially anteriorly	OTH	OTH	Hydrocodone Bitartrate; Tylenol, Motrin, AK-Sulf		chronic bilateral otitis media; bilateral myringotomy with tube placement		MPU199900526	1						1	Bacterial infection; Chills; Conjunctivitis; Cough; Pneumonia; Respiratory disorder	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0157626	07/20/2000	IN	43.0	43		F	01/07/2000	2 days post vax pt developed hives on the left cheek. Within a day of this the left cheek became a little swollen. Within one week of vax the pt developed hives to the lower body and left arm. One week post onset the vaccinee experienced severe epigastric pain and elevated blood pressure, 3 days later symptoms were persisting and her lips had become swollen. Pt developed new hives which worsened; her head had swollen down to her forehead, she had a fever of 102 and chills. The following day she was not able to open her right eye and could barely open the left eye. Follow up information states the pt experienced a pruritic rash on legs and left side of face, large erythematous macular plaque on left thigh and right popleteal and lesion on shin 4 days post vax.									U	11/08/1999	11/11/1999	3		PVT	OTH	NONE		small herniated disc L5S1		MPU1999005510	1						1	Abdominal pain; Blood pressure increased; Face oedema; Pyrexia; Rash maculo-papular; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E24879GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0157646	07/20/2000		48.0	48		F	05/05/2000	Pt experienced a severe local injection site reaction.									Y	11/07/1994	11/07/1994	0		OTH	OTH	Trimethoprim, Nafarin, Codeine, Phosphate, Nydroxocobalamin		ampicillin, erythromycin, fluoloxacillin allergies; Crohn's disease; deep vein thrombosis		MPU1999005610	1						1	Injection site reaction	FLU3~MEDEVA PHARMA, LTD.~~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0157647	07/20/2000		71.0	71		F	12/21/1999	1 day post vax pt experienced an itchy blotchy rash with bruising at the center of the lesions. Pt was referred to the dermatologist with a very widespread urticated eruption. Pt was treated with antihistamines and topical emollients and the rash resolved after about 4 weeks.									Y	10/01/1999				OTH	OTH			osteoarthritis, hypertension, endometrial carcinoma		MPU1999005630	1						1	Contusion; Pruritus; Rash	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0157651	07/20/2000	IL				F	12/30/1999	Pt felt a burning sensation once the vaccine was administered. Pt also reported a missing label.									U	10/01/1999				OTH	OTH	NONE				MPU1999005760	1						1	Skin burning sensation	FLU3~MEDEVA PHARMA, LTD.~E26989GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0157655	07/20/2000	IL	35.0			M	01/13/2000	Pt experienced itching after receiving influenza vaccine inadvertently. The intended vaccine was tuberculin. Itching resolved within 24 hours.									Y	10/01/1999				OTH	OTH	NONE				MPU2000000180	1						1	Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0133532	07/21/2000	NC	52.0	52		F	01/20/2000	It was reported that a 52 year old female received a Fluzone SV 99-00 vaccination on 10/26/1999 at 6:00 pm. Reportedly immediately after the vaccination, the patient experienced a warm flush all over the body, she felt weird. Her blood pressure rose to 168/112 and pulse to 106. The patient went to the ER where the doctor prescribed Enderal. The patient then experienced pain in her chest. The patient was then taken to another hospital where a doctor prescribed Prednisone. The patient also developed large blisters on her hands and had spotted vision in her right eye. The patient had not yet fully recovered, she is still experiencing pain at the injection site. From follow up correspondence received at Aventis Pasteur Inc. On 03/10/00, it was reported, No additional information. From follow up correspondence received at Aventis Pastreur,Inc. on 05/15/00, it was reported that the patient did fully recover from the adverse event, and there was no result of permanenet disability. It was also reported that the patient had a pre-existing condition of Stephens Johnson syndrome. The patient was being treated for this condition at the time of vaccination. Follow-up 06/14/02: during internal review of all files, it was deemed necessary to amend the report by updating Adverse Event coding (added depersonalization, chest pain and tachycardia). Also re-ranked Adverse Events which did not change the onset date.			Y	Y					Y	10/26/1999	10/26/1999	0	CAT scan, Histamine response, checked for possible heart attack.	OTH	PVT		Stevens Johnson Syndrome	Steven Johnson 5/3/98, Allergy to sulfer and antibiotics		U200000031	1						1	Chest pain; Hypertension; Injection site pain; Personality disorder; Stevens-Johnson syndrome; Tachycardia; Vasodilatation; Visual disturbance; Chest pain; Hypertension; Injection site pain; Personality disorder; Stevens-Johnson syndrome; Tachycardia; Vasodilatation; Visual disturbance	FLU3~CONNAUGHT LABORATORIES~U0131AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0131AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening	Influenza
0133532	07/21/2000	NC	52.0	52		F	01/20/2000	It was reported that a 52 year old female received a Fluzone SV 99-00 vaccination on 10/26/1999 at 6:00 pm. Reportedly immediately after the vaccination, the patient experienced a warm flush all over the body, she felt weird. Her blood pressure rose to 168/112 and pulse to 106. The patient went to the ER where the doctor prescribed Enderal. The patient then experienced pain in her chest. The patient was then taken to another hospital where a doctor prescribed Prednisone. The patient also developed large blisters on her hands and had spotted vision in her right eye. The patient had not yet fully recovered, she is still experiencing pain at the injection site. From follow up correspondence received at Aventis Pasteur Inc. On 03/10/00, it was reported, No additional information. From follow up correspondence received at Aventis Pastreur,Inc. on 05/15/00, it was reported that the patient did fully recover from the adverse event, and there was no result of permanenet disability. It was also reported that the patient had a pre-existing condition of Stephens Johnson syndrome. The patient was being treated for this condition at the time of vaccination. Follow-up 06/14/02: during internal review of all files, it was deemed necessary to amend the report by updating Adverse Event coding (added depersonalization, chest pain and tachycardia). Also re-ranked Adverse Events which did not change the onset date.			Y	Y					Y	10/26/1999	10/26/1999	0	CAT scan, Histamine response, checked for possible heart attack.	OTH	PVT		Stevens Johnson Syndrome	Steven Johnson 5/3/98, Allergy to sulfer and antibiotics		U200000031	1						2	Chest pain; Hypertension; Injection site pain; Personality disorder; Stevens-Johnson syndrome; Tachycardia; Vasodilatation; Visual disturbance; Chest pain; Hypertension; Injection site pain; Personality disorder; Stevens-Johnson syndrome; Tachycardia; Vasodilatation; Visual disturbance	FLU3~CONNAUGHT LABORATORIES~U0131AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0131AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening	Influenza
0157722	07/21/2000	IL	42.0	42		F	05/03/2000	Subsequent to receiving an injection of Flu Shield, pt was seen by a physician who diagnosed hepatitis B. Physician indicated in a follow-up report that he does not believe the pt developed hepatitis B as a result of the vax.				Y					U	10/25/1999	12/10/1999	46	UNK	OTH	PVT	UNK	UNK	UNK		HQ0296205JAN2000	1						1	Infection	FLU3~PFIZER\WYETH~4998227~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0157723	07/21/2000	IL				U	06/09/2000	A physician reported that many pts received an injection of Flu Shield and developed the same severity of symptoms and complications as those pts who were not vaccinated.									U				UNK	PVT	OTH	UNK	UNK	UNK		HQ0296705JAN2000	1						1	Unevaluable event	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0157724	07/21/2000	MO	42.0	42		F	02/14/2000	Within a few hours post vax, pt developed swelling at the injection site which looked like a coconut and numbness at the base of her wrist. The injection site was inside her forearm 2.5 inches from the elbow. Within two days post vax a large amount of swelling was present and she was seen in the ER.				Y					Y	11/19/1999	11/19/1999	0	UNK	PVT	OTH	NONE		UNK		HQ0319706JAN2000	1						1	Hypoaesthesia; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0157725	07/21/2000	NY				U	06/09/2000	A pharmacist reported that several employees received Flu Shield and subsequently developed the flu. The reporter stated that the vaccine may have been left out.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ0361607JAN2000	1						1	Influenza like illness	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0157726	07/21/2000	OH	44.0			F	01/26/2000	A few days post vax pt developed generalized muscle aches, weakness in her arms and legs, swollen hands and malaise.									U	10/11/1999			UNK	PVT	PVT	UNK	NONE	UNK		HQ0400010JAN2000	1						1	Malaise; Muscular weakness; Myalgia; Oedema peripheral	FLU3~PFIZER\WYETH~4998217~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0157727	07/21/2000	NY	44.0	44		M	02/15/2000	Within 20 minutes post vax the pt developed a golf ball sized swelling of his elbow. The swelling was reported to be an allergic reaction. As of 3 day post vax the swelling persisted. Pt is being seen by a specialist.									U	01/10/2000	01/10/2000	0	UNK	PVT	OTH	NONE	NONE	UNK		HQ0469313JAN2000	1						1	Oedema peripheral	FLU3~PFIZER\WYETH~~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0157728	07/21/2000	OH	44.0			F	01/24/2000	A few days post vax, pt developed weakness in her arms and legs, muscle aches and malaise. The pt felt slower with not much stamina.									U	10/11/1999			UNK	PVT	PVT	UNK	NONE	hypersensitivity NOS; allergic to wheat, eggs, chocolate, citrus fruits, dust grass, ragweed, sulfa and PCN; eczema NOS		HQ0540318JAN2000	1						1	Malaise; Muscular weakness	FLU3~PFIZER\WYETH~4998217~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0157729	07/21/2000	IL	27.0	27		F	03/23/2000	Subsequent to inadvertently receiving Flu Shield subcutaneous, the pt developed swelling and bruising at the injection site. One day post vax a diagnosis of cellulitis was made and the pt was treated with Keflex.									Y	01/14/2000	01/14/2000	0	UNK	PVT	PVT	Glyburide; oral contraceptive NOS	NONE	UNK		HQ0629020JAN2000	1						1	Cellulitis; Injection site haemorrhage; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0157730	07/21/2000	WA	46.0			F	03/22/2000	Subsequent to receiving vaccine pt developed pain and tingling in the lower arm. Pt was seen in the ER and was told by the attending physician that it was probably due to the administration technique. He sated that the vax may have been administered into her bursa.				Y					U				UNK	OTH	OTH	UNK	UNK	UNK		HQ0640820JAN2000	1						1	Pain; Paraesthesia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0157731	07/21/2000	AL				F	03/23/2000	Subsequent to receiving vax, pt developed an injection site reaction characterized by hypopigmentation, adipose changes, induration in which 2 fingers can fit and an area of swelling the size of an orange.									U	11/12/1999			UNK	PUB	OTH	UNK	UNK	UNK		HQ0739527JAN2000	1						1	Injection site mass; Skin discolouration	FLU3~PFIZER\WYETH~4998276~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0157732	07/21/2000					F	02/03/2000	Subsequent to receiving vax, pt developed numbness and tingling of her hands and feet lasting for 3 months.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ0894003FEB2000	1						1	Hypoaesthesia	FLU3~PFIZER\WYETH~~7+~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0157733	07/21/2000	TX	20.0			F	03/24/2000	Approximately 4 months post vax, this pt experienced chills, aches, and swollen joints. Pt was seen in the ER and indicated that she had experienced those symptoms for some time.				Y					U	10/28/1999	02/21/2000	116	UNK	OTH	PVT	UNK	UNK	UNK		HQ1184023FEB2000	1						1	Chills; Joint swelling; Pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0157734	07/21/2000	OR	66.0	66		F	03/23/2000	Subsequent to receiving vax, pt developed muscle cramps and weakness.				Y					U	10/01/1999			UNK	PUB	PUB	Premarin unspecified; Slo-Bid unknown; oral	NONE	UNK		HQ1501310MAR2000	1						1	Muscle spasms; Muscular weakness	FLU3~PFIZER\WYETH~~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0157735	07/21/2000	NC	1.8	1	.9	M	06/09/2000	Subsequent to receiving second dose of influenza virus vaccine pt developed difficulty breathing and abdominal pain. Pt was treated with Benadryl and the symptoms resolved.									U	11/01/1999			UNK	PVT	OTH	UNK	UNK	Food allergy to eggs, milk, grains, and fruits.		HQ1735722MAR2000	1						1	Abdominal pain; Dyspnoea	FLU3~PFIZER\WYETH~~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0157736	07/21/2000	CA	63.0			F	04/18/2000	Subsequent to receiving flu vaccine, pt developed pneumonia. Laboratory tests revealed an elevated white blood cell count and a decreased red blood cell count. A chest x-ray revealed pneumonia.									U				white blood cell count increased; red blood cell count decreased	OTH	OTH	Atenolol; Celecoxib; Enbrel; Fosamax; Prilosec; Prinivil	Rheumatoid arthritis	Rheumatoid arthritis		HQ1785623MAR2000	1						1	Pneumonia; Red blood cell count decreased; White blood cell count increased	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0157737	07/21/2000	NJ				U	04/04/2000	Subsequent to receiving vax, the pt was diagnosed with influenza A virus infection confirmed by nasal swab.									U	10/13/1999	12/18/1999	66	UNK	OTH	OTH	UNK	UNK	UNK		HQ0447112JAN2000	1						1	Influenza like illness	FLU3~PFIZER\WYETH~4998209~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0157741	07/21/2000	WA	41.0			F	03/22/2000	Subsequent to receiving the vaccine, pt developed injection site pain described as tender, and she developed severely decreased range of motion in her arm. She was seen by the employee physician.				Y					U	01/06/2000	01/06/2000	0	UNK	OTH	OTH	UNK	UNK	UNK		HQ1720221MAR2000	1						1	Injection site pain; Joint range of motion decreased	FLU3~PFIZER\WYETH~4998230~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0157895	07/25/2000	OH	36.0	35		F	06/23/2000	Pt experienced redness, swelling and pain after injection. Physical therapy was ordered - visit with orthopedic doctor week of 02/14/2000.				Y					Y	01/12/2000	01/12/2000	0		PUB	UNK		NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~U0160AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0157907	07/25/2000	TX	36.0	36		F	06/27/2000	Approximately 2 weeks post vax pt experienced body aches, difficulty with balance and walking. Symptoms continued for about 2 months and all symptoms stopped. Symptoms returned 3 weeks later with numbness, muscle twitching, fatigue. Pt continues evaluation with neurologist.									N	01/18/2000	02/02/2000	15	MRI of brain, testing for lupus and multiple sclerosis	UNK	PUB	NONE	NONE	NONE		TX00086	1						1	Balance disorder; Difficulty in walking; Fatigue; Hypoaesthesia; Muscle twitching; Pain	FLU3~CONNAUGHT LABORATORIES~U0165AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0157993	07/27/2000		61.0			M	07/14/2000	This 61-year-old pt was inadvertently administered a subcutaneous injection, instead of intra-muscular, of Flu-Shield on 10/01/1999. On 06/22/2000, the pt was hospitalized and neurologist made a dx of Guillain-Barre syndrome. While this is a labeled side effect, the reporter is not sure that the neurologist's dx is correct. Pt was treated with IV immunglobulin. Eight days later the pt had recovered and was discharged.					Y	8			Y	10/01/1999	06/22/2000	265		UNK	UNK						1						1	Guillain-Barre syndrome	FLU3~PFIZER\WYETH~1998225~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0158097	07/28/2000	NY	28.0	27		F	05/19/2000	Numbness to left arm, face and chest; possible MS. (Please let me know if related).									U	11/04/1999	11/07/1999	3		OTH	PVT		NONE				1						1	Hypoaesthesia	FLU3~CONNAUGHT LABORATORIES~U0065AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0158198	08/01/2000	PA				F	07/27/2000	Subsequently post vax, the pt died due to unknown causes. The pt's family feels that it was secondary to receiving those vax. FU information received from a physician which indicated that as per the patient's daughter/daughter-in-law, the patient did not die. No further information is available. WAES 00032767 will be voided from the mfg's database.									N					OTH	OTH			UNK		WAES00032767	1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0158202	08/01/2000	WV	74.0	74		M	07/27/2000	Information has been received from a physician concerning a 74 year old male who on 10/11/99 was vaccinated. On 10/11/99, post vax, the pt experienced paresthesia (numbness) of right arm from site of injection down to the fingers. Upon medical review, the pt's condition was considered an 'important medical event.' Follow-up information received, indicated that the pt was seen at the clinic following his CT scan and was much improved. The physician believed that his condition was complicated by the fact that the pt had experienced a stroke on the same side. No further details were provided.				Y					N	10/11/1999	10/11/1999	0	Computed axial 10/12/99 scheduled for 14:00	OTH	OTH			CVA, TIA		WAES99100930	1						1	Injection site reaction; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0158220	08/01/2000	WA	9.0	8		F		Pt with 4cm erythema on left upper arm and shoulder, streaking of entire shoulder and left neck. She has a fever to 104.5F, onset 10/29/99 and peaked 10/30/99, duration 5 days. Also, has a headache and vomiting.				Y					Y	10/27/1999	10/30/1999	3		PVT	PUB	Flovent, Flonase, Singulair, Claritin, Proventil	NONE	asthma, allergic rhinitis, chronic sinusitis and otitis			1						1	Headache; Injection site erythema; Pyrexia; Skin striae; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0130AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1573H~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0122103	08/02/2000	PA	67.0			F	07/27/2000	On 10/13/98, the pt began experiencing pain in what she calls drawing in the left upper arm and shoulder. The pt has noted numbness in the left hand since then. The pt feels that the arm is awkard but doesn't note any actual weakness. The pt had a cortisone shot in the shoulder, which did not help. The pt was on 10 or 12 days of prednisone therapy, which has not help. The pt has continuing pain largely between her elbow and shoulder blade and persistant numbness in the fingers of the left hand. The pt noted no heat or swelling. There is no difference whether sh is moving the arm or not. The pt has not experienced pain or any other difficulities in her right arm. She has no difficulty in moving the head or in either leg.  Impression: possible brachial plexus neuritis.				Y					U	10/12/1998	10/13/1998	1		OTH	OTH	Arthrotec, Serax, Paxil		anxiety, depression, obesity		WAES99111250	1						4	Hypoaesthesia; Pain	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~4|PPV~MERCK & CO. INC.~~UNK~~RA~PNEUMO (PNEUMOVAX)~4	USA	Emergency room visit	Influenza
0129372	08/02/2000	TN	27.0	27		F	07/27/2000	On 10/7/99, the pt developed an injection site reaction characterized by redness, swelling, heat, and pruritus which extended to the elbow. The following morning the pt awoke with cellulitis of the right arm approximately 20 cm x 10 cm around the injection site.				Y					Y	10/07/1999	10/07/1999	0		PVT	OTH		sinusitis	cephalexin allergy, codeine allergy, PCN allergy		WAES00012686	1						2	Cellulitis; Injection site hypersensitivity; Injection site oedema; Pruritus; Vasodilatation; Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~MERCK & CO. INC.~1592H~1~IM~RA~PNEUMO (PNEUMOVAX)~2|FLU3~PFIZER\WYETH~4998224~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~3|PPV~MERCK & CO. INC.~1692H~UNK~IM~RA~PNEUMO (PNEUMOVAX)~3	USA	Emergency room visit	Influenza
0131497	08/02/2000	MO	62.0	62		M	07/27/2000	Information has been received from an RN concerning a 62 year old male who on 10/26/99 was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent and influenza virus vaccine. On 10/30/99, the pt experienced right arm swelling and tenderness, as well as, bruising on fingers. Also, the finger were warm to the touch and were swollen. No further information is available.									U	10/28/1999	10/30/1999	2		PUB	PUB			UNK		WAES99112020	1						2	Ecchymosis; Injection site oedema; Injection site pain; Oedema peripheral; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~0163AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0042J~2~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0131498	08/02/2000	MO	85.0	85		F	07/27/2000	Information has been received from a health dept. concerning an 85 year old female pt who on 10/25/99, was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent and influenza virus vaccine. That evening, the pt developed redness and warmth from the right upper deltoid to the elbow. Subsequently, the pt recovered. Additional information has been requested.									Y	10/25/1999	10/25/1999	0		UNK	UNK			UNK		WAES99112018	1						2	Injection site hypersensitivity; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0042J~2~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0132572	08/02/2000	NC	30.0	30		F	07/27/2000	On 11/17/99, the pt experienced injection site redness (3 inches radius), 5 to 7 cm area of localized edema, injection site swelling and warmth on right lateral deltoid area surrounding site of vax, accompanied by fever of 102, myalgia and malaise with body aches. The next day, the pt was seen by a physician and was placed on therapy with unspecified antibiotic. Subsequently, the pt recovered from all of her experiences. No further details are expected.				Y					Y	11/16/1999	11/17/1999	1		PVT	PVT	Synthroid		Hodgkin's lymphoma, hypothyroidism, paroxysmal supraventricular tachycardia		WAES99111542	1						2	Injection site hypersensitivity; Injection site oedema; Malaise; Myalgia; Pyrexia; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0043J~1~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0154013	08/02/2000	VA				M	07/27/2000	Within 30 minutes post vax, this pt developed blood blisters in his throat. He was instructed to be seen by a physician.				Y					U	11/13/1999	11/13/1999	0		OTH	PVT			pharyngeal infection		WAES00012689	1						2	Oral mucosal blistering; Blister	FLU3~PFIZER\WYETH~4998249~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1693H~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~MERCK & CO. INC.~1693H~1~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0158298	08/02/2000	UT	22.0	22		F	02/06/2000	Mother reports pain, redness, swelling, hard lump the day after shots. Doesn't know when she couldn't move her arm or when pain started to spread to head, neck, and back.				Y					U	11/30/1999	12/01/1999	1		OTH	PVT		NONE				1						1	Erythema; Pain; Skin nodule; Swelling	FLU3~CONNAUGHT LABORATORIES~U0145CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~00442~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0158299	08/02/2000	UT	28.0	28		M		Red streaks from injection site. Lymph nodes swollen and painful. Treated with IV antibiotics, oral antibiotics, prednisone, and ibuprofen.				Y					Y	10/11/1999	10/11/1999	0	NONE	OTH	PVT	Claritin	NONE	hay fever			1						1	Cellulitis; Hypersensitivity; Lymph node pain; Lymphadenopathy	FLU3~PARKDALE PHARMACEUTICALS~03279P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~1611H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0158300	08/02/2000	VT	27.0	27		F	10/22/1999	10/12, the same day as vax, the pt experienced redness, swelling and hot. 10/17 five days post vax, the pt experienced increased redness and warmth. Antibiotics were given. On 10/20, area was red and hard and an appointment with a private MD was made. 10/22, the pt is improved and continues on antibiotics.				Y					Y	10/12/1999	10/12/1999	0	NONE	OTH	PVT		NONE				1						1	Erythema; Feeling hot; Oedema; Skin nodule	FLU3~CONNAUGHT LABORATORIES~U0145CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~U011H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0158301	08/02/2000	UT	15.0	15		F	11/05/1999	The pt complained of aching in joints, reddened rash on elbows and knees.									Y	11/05/1999	11/05/1999	0		UNK	UNK		Sore throat	allergy to PCN			1						1	Arthralgia; Erythema; Rash	FLU3~CONNAUGHT LABORATORIES~U0128EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0158302	08/02/2000	VT	32.0	32		F	11/05/1999	The pt complained of itching arms, legs with a rash. The pt experienced a burning throat, increased pressure in the chest. 911 was called.				Y					Y	11/05/1999	11/05/1999	0	NONE	OTH	UNK		NONE				1						1	Chest discomfort; Pharyngolaryngeal pain; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0145CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0158351	08/02/2000	NE	4.0			F	07/27/2000	Approximately 24 hours post vax, this pt developed a fever of 105 F. The pt sought medical attention and subsequently recovered.				Y					Y	01/21/2000	01/22/2000	1		UNK	UNK			FEVER		WAES00020065	1						1	Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0045J~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0158514	08/02/2000	MI	55.0	55		F	07/27/2000	Initial and follow-up information has been received from an RN concerning a 55 year old white female pt who was vaccinated with a 2nd dose of pnemococcal vaccine 23 polyvalent and the 1st dose of influenza virus vaccine. It was noted that the 2 vaccines were administered in the same arm. On 10/5/99, the pt experienced injection site redness, tenderness, and hardness. In addition, the injection site was swollen. The pt also complained of shortness of breath although lungs clear to auscultation with dry mouth. She was seen by a physician the next day, because her physician expressed concern that she might experience abscess in the arm. She was also scheduled to see a physician for re-evaluation. Subsequently, the pt recovered from all her experiences. No further details are expected.				Y					Y	10/05/1999	10/05/1999	0		PVT	PVT			Allergy to iodine		WAES99100671	1						1	Dry mouth; Dyspnoea; Injection site abscess; Injection site erythema; Injection site induration; Injection site pain; Injection site swelling	FLU3~CONNAUGHT LABORATORIES~~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1584H~2~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0158515	08/02/2000	MI	65.0	65		M	07/27/2000	Information has been received from an RN concerning a 65 year old white male pt who was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent IM in the right arm and  also a 2nd dose of influenza virus vaccine IM in the left arm. Later that same day, the pt presented with a reaction at the injection site where pneumococcal vaccine 23 was administered that consisted of a little redness, swelling and tenderness. The pt was advised to take Tylenol and apply ice to the involved area. Follow-up information from an RN reported that subsequently the pt recovered.				Y					Y	10/05/1999	10/05/1999	0		UNK	UNK		Cough	PCN allergy		WAES99100673	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~CONNAUGHT LABORATORIES~~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1584H~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0158534	08/02/2000	GA	22.0	22		F	07/27/2000	Same day post vax, the pt experienced soreness in arm. Also, she experienced flu-like symptoms accompanied by fever and pain. She had a fever of approximately 102-103.									Y	10/15/1999	10/15/1999	0		UNK	UNK			UNK		WAES99101419	1						1	Influenza like illness; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0042J~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0158538	08/02/2000	OH	66.0	66		F	07/27/2000	5 minutes post vax, the pt experienced a very sore arm that she could barely move. In addition, the pt's arm was red and swollen down to her fingers. The symptoms progressed to generalized pain on the whole right side of her body. The pt thinks she also had a fever, but no temperature measurement was taken. 24 hours later, the pt recovered.				Y					Y	10/18/1999	10/18/1999	0		PUB	PUB			UNK		WAES99101699	1						1	Erythema; Hypokinesia; Oedema peripheral; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1585H~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0158539	08/02/2000	OH	66.0	66		F	07/27/2000	5 hours post vax, the pt experienced a stiff neck and muscle aches in the injection site arm. Unspecified medical attention was sought. It was indicated that the pt's right arm became very sore with some swelling and redness that progressed to generalized muscle pain on the right side including stiff neck.				Y					Y	10/18/1999	10/18/1999	0		PUB	PUB			UNK		WAES99101777	1						1	Erythema; Musculoskeletal stiffness; Myalgia; Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1585H~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0158548	08/02/2000	TN				U	07/27/2000	Post vax, the pt experienced fevers of approximately 102 and a flu-like sickness. Unspecified medical attention was sought.				Y					U					PVT	OTH			UNK		WAES99102027	1						1	Influenza like illness; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0158551	08/02/2000	MO				U	07/27/2000	8 hours post vax, the pts experienced swelling, redness, and heat on the under side of their arms, away from the injection site. Unspecified medical attention was sought.				Y					U					OTH	OTH			UNK		WAES99102127	1						1	Erythema; Feeling hot; Oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0042J~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0158556	08/02/2000	NY	63.0	63		F	07/27/2000	Same day post vax, the pt's right upper arm blew up, with redness and intense pain to the touch. She sought unspecified medical attention.				Y					Y	10/21/1999	10/21/1999	0		PVT	UNK	cephalexin, Cipro, Guaifenex DM		allergy, cough, hip pain, obesity		WAES99102354	1						1	Erythema; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1693H~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0158559	08/02/2000	CA				U	07/27/2000	Post vax, two  pts experienced fevers of 102 and 103 degrees. The other two pts developed large red lumps from shoulder to elbow with intense pain.									U					OTH	OTH			UNK		WAES99110450	1						1	Pyrexia; Skin nodule	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1692H~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0158568	08/02/2000	OR	40.0	40		M	07/27/2000	12 hours post vax, the pt experienced a low grade fever. Later that night, the pt experienced a fever of 102. Two days later, the pt again experienced a low grade fever, as well as a headache and general malaise.									U	10/11/1999	10/11/1999	0		OTH	OTH			UNK		WAES99110867	1						1	Headache; Malaise; Pyrexia; Headache; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1|FLU3~CONNAUGHT LABORATORIES~U0063AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~459040~UNK~IM~~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0158575	08/02/2000	WA	71.0	71		F	07/27/2000	On 11/19/99, the pt experienced muscle rigidity and a red round ring that traveled down the elbow. The pt's elbow was tender. The pt felt that the symptoms were related to therapy with vax.									U	11/19/1999	11/19/1999	0		UNK	UNK	Lipitor, Premarin, Plendil, hydrochlorothiazide, Detrol		CVA, ophthalmic hemorrhage, drug allergy		WAES99111646	1						1	Erythema; Muscle rigidity	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0158641	08/02/2000	KS	61.0	61		F	07/27/2000	Information has been received from a NP concerning a 61 year old white female who was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent. via the right deltoid. On the same day, she also received an influenza virus vaccine. Subsequently, the pt experienced injection site reaction described as swollen arm with redness (injection site arm). Also, she developed significant flu symptoms. It was noted that the pt had no previous reaction to flu shots. Pt was presented to a physician and treatment with hydrocortisone cream and Benadryl was initiated, but despite the treatment, the arm redness persisted. Therapy with Decadron was recommended. Subsequently, the pt recovered. No further information is available.				Y					Y	11/15/1999	11/16/1999	1		PVT	PVT	Premarin, Vasoretic		allergy to erythromycin		WAES99120012	1						1	Influenza like illness; Injection site erythema; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1692H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0157382	08/03/2000	MD	60.0	60		F	06/09/2000	The pt experienced headaches, eye movement pain, congestion. The began approximately 3 weeks post vax and continue today. Headaches are caused by a diagnosed inflamed meninges.					Y				N	11/19/1999	12/05/1999	16	blood tests, limited ct scan, spinal tap, MRI - abnormal	PUB	PUB	Pepcid, Prinivil	NONE	hypertension, acid reflux			1						2	Eye pain; Headache; Nasal congestion; Eye pain; Headache; Laboratory test abnormal; Meningitis; Nasal congestion; Eye pain; Headache; Meningitis; Nasal congestion	FLU3~PARKDALE PHARMACEUTICALS~01989P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~01989P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2|FLU3~PARKDALE PHARMACEUTICALS~01989P~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUOGEN)~3	USA	Hospitalisation	Influenza
0158465	08/07/2000	NJ	41.0			F	08/04/2000	Within one week post vax, the pt complained of aching in every joint and in her hands. All symptoms resolved except for pain and swelling in the right hand ring finger.									N	10/01/1999	10/07/1999	6		PVT	PVT			asthma, seasonal allergies		20000228441	1						1	Arthralgia	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|LYME~SMITHKLINE BEECHAM~~1~IM~RA~LYME (LYMERIX)~1	USA		Influenza
0151035	08/10/2000	LA	54.0	54		M		This report was received from an attorney regarding a 54-year-old who within 10 days of receiving vax experienced vomiting and diarrhea. The vaccinee visited family physician who believed that he had some type of virus. Twenty day post vax, he was admitted to the hospital due to paralysis, which resulted in the inability to move his hands, arms, or legs. He remained in a paralyzed state for a number of months and was dxed as suffering Guillain-Barre syndrome. He was transferred after 16 days to a rehabilitation hospital where he underwent long-term rehabilitation program and discharged after 191 days. Physical therapy was received at home for a period of 4-6 weeks. This therapy was discontinued for financial and insurance reasons. The pt continues to be weak and disabled as a result of his ongoing condition. He is unable to walk in a normal fashion, can only walk for short periods of time, and must us a stand-up walker. He is extremely weak, unable to life more than a few pounds and is in need of long-term care and physical therapy.				Y	Y	207	Y	Y	N	11/17/1998	11/27/1998	10		OTH	OTH	NONE				MPU200000406	1						2	Diarrhoea; Difficulty in walking; Guillain-Barre syndrome; Muscular weakness; Paralysis; Vomiting; Diarrhoea; Difficulty in walking; Guillain-Barre syndrome; Muscular weakness; Paralysis; Vomiting	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation,Disabling	Influenza
0158770	08/14/2000					U		Large local reaction 20 x 20 cm on left tricep.										12/01/1999	12/02/1999	1		MIL	MIL	Prilosec	NONE	NONE			1						1	Injection site reaction	ANTH~EMERGENT BIOSOLUTIONS~FAV024~2~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~UO258AA~1~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1|JEV~CONNAUGHT LABORATORIES~EJNA169A~2~SC~~JAPANESE ENCEPHALITIS (J-VAX)~1	USA		Influenza
0158944	08/16/2000	KS				F	05/19/2000	Post vax, the vaccinee developed cold symptoms.									U				UNK	PUB	OTH	UNK	UNK	UNK		HQ6058518MAY2000	1						1	Pharyngitis; Rhinitis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|MEN~CONNAUGHT LABORATORIES~~1~~~MENINGOCOCCAL (MENOMUNE)~1|OPV~PFIZER\WYETH~~1~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~1|YF~CONNAUGHT LABORATORIES~~1~~~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0107217	08/17/2000	OH	57.0	57		F	07/28/1998	It was reported, pt developed lumps in her breast after receiving the flu vaccine. Went to a specialist. From follow-up of 7/28/98, it was reported that the pt recovered from this experience.				Y					Y	10/21/1997			Breast biopsy	PUB	PVT	Tenormin, Prempro, Zocor, Fibercon, Colright	NONE	HTN, dust allergy		U1998002050	1						2	Breast neoplasm	FLU3~CONNAUGHT LABORATORIES~7P81904~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|TD~CONNAUGHT LABORATORIES~7E91657~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0107680	08/17/2000	WI	71.0	71		F	01/19/1999	October 3, 1997 the pt developed red blotches and could not use the arm shot was administered in. February 23, 1998, muscle aches in arms, buttocks, legs, knees, 3-4 red blotches continues to have symptoms of aches/stiffiness. They say I have Palymyalgia Rheumatica. This came overnight the week I got the flu shot. On Prednisone, States diagnosed with fibromyalgia. States doctor said couldn't say problems were or were not related to Flu shot. States she doesn't have the pain she had.				Y					N	10/01/1997	10/03/1997	2	Not arthritis, not infection	PUB	PUB	Hydorchlorothiazide, Atenolol				U1998000140	1						3	Hypokinesia; Myalgia; Rash maculo-papular	FLU3~CONNAUGHT LABORATORIES~7F81746~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Emergency room visit	Influenza
0114296	08/17/2000	MD	52.0	52		F	09/24/1998	It was reported that a 52 year old female received Fluzone WV 98-99 on September 15, 1998. Reportedly on September 16, 1998 the patient experienced localized redness (5cm in width), swelling (0.5 cm), itching and pain at site of injection. Applied cool pack to site. Claritin Reditab 10 mg one sublingually while in ofice. One tab a day for three days.				Y					Y	09/15/1998	09/16/1998	1		PVT	PVT	Plegine 35 mg		Allergic Rhinitis		U1998005530	1						2	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus	FLU3~CONNAUGHT LABORATORIES~0973920~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0114323	08/17/2000	MD	83.0	83		F	11/05/1998	Reportedly on 09/20/1998 the pt experienced redness, soreness, itching and swelling at injection site, size of 50 cent piece. Cool pack to be applied to site. Injection site NYSN, Pain, Edema, Pruritus.				Y					Y	09/19/1998	09/20/1998	1		PVT	PVT	Glucophage	NONE	Sulfa Allergy		U1998005500	1						2	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus	FLU3~CONNAUGHT LABORATORIES~0973920~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0114324	08/17/2000	MD	49.0	49		F	11/05/1998	Reportedly on September 20, 1998 the pt experienced localized redness, pain and swelling at site of injection. Size 50 cent piece.									Y	09/19/1998	09/20/1998	1		PVT	PVT	Allopurinol, Claritin, Coumadian, Cardizem, Digoxin, Prem Pro	NONE	Sulfa, Darvon, Chocolate Allergies		U1998005510	1						2	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~0973920~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0114660	08/17/2000	PA	42.0	42		F	10/05/1998	Fifteen minutes post vax, the pt experienced throat thightening, coughing and erythema. Reportedly responded to Benadryl 500 IM and Epi 1cc IM x 2 and Dexametharone IM and now on oral steroids.				Y					Y	09/25/1998	09/25/1998	0		PVT	PVT		NONE	NONE		U1998005910	1						2	Cough; Laryngospasm; Rash	FLU3~CONNAUGHT LABORATORIES~0968410~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0114779	08/17/2000	MD	50.0	50		F	10/02/1998	Redness, swelling, hot to touch, localized reaction size of a quarter. (Verbal report per pt, 2 wks after incident)									Y	09/18/1998	09/19/1998	1	Hysn, Edema inject site	PVT	PVT		NONE	Ceclor allergy, rash		U199800589	1						2	Hypersensitivity; Injection site hypersensitivity; Injection site oedema; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~0973920~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0114821	08/17/2000	OH	49.0	49		F	10/13/1998	Six hours post vax, the pt experienced fever, muscle aches which progressed through 10/6/98.									U	10/05/1998	10/05/1998	0		UNK	UNK					U1998006060	1						2	Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0973930~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0114824	08/17/2000	NY	68.0	68		F	11/12/1998	Two days post vax, the pt was not able to lift her arm over the weekend.									Y	10/01/1998	10/03/1998	2		PUB	UNK	Procardia				U1998005920	1						2	Hypokinesia	FLU3~CONNAUGHT LABORATORIES~0971880~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0114980	08/17/2000	IN	37.0	37		F	12/22/1998	Same day post vax, the pt experienced fever, shortness of breath, and facial swelling.				Y					Y	10/02/1998	10/02/1998	0		UNK	UNK					U1998005950	1						2	Dyspnoea; Face oedema; Pyrexia	FLU3~CONNAUGHT LABORATORIES~0969600~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0119668	08/17/2000	MN	48.0	48		F	07/28/1998	5 minutes post vax, the pt experienced severe wrist pain; 2 days later muscle pain. Also, numbness in extremities; then severe burning feeling in legs.									N	10/27/1997	10/27/1997	0		PVT	PVT		NONE	Mitral valve prolapse, allergy eye contact solution and sulfa adverse reaction.		U1998002210	1						2	Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~7F81856~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0119669	08/17/2000	WA	38.0	38		M	09/25/1998	Reportedly the injection appeared to be normal on November 9, 1997 but his triceps muscle area became sore and by November 12, 1997 he favors his left arm with marked avoidance of lifting. The pt especially gets weak with arm abduction. On exam the pt is tender at posterior deltoid triceps left side. No fluctuance, local ulcer or enlargement or induration. There is no atrophy or distinct paresis and no paresis or vascular change.				Y					N	10/09/1997	10/09/1997	0		OTH	OTH	NONE	NONE	NONE		U1998002230	1						2	Myasthenic syndrome; Pain	FLU3~CONNAUGHT LABORATORIES~7F81736~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0125956	08/17/2000	TX	44.0	44		F	12/08/1998	It was reported that a 44 year old female received Fluzone, TD and Pneumovax vaccines on 10/6/98. Reportedly, on 10/7/98, the pt complained of chest tightness, myalgia and muscle cramping. From additional information of 10/13/98, it was reported that the pt experienced shortness of breath, pain under her right arm and across her back; feels as though someone beat her. Numbness in arms and fingers, back spasms and nauseated. Treatment of Benadryl IM and Toradol IM was given. Reportedly, the pt recovered from this experience. From additional information received on 12/8/98, it was reported that the pt recovered in 24 hours.									Y	10/06/1998	10/07/1998	1	EKG-normal sinus rhythm, no acute changes, exam negative	PVT	PVT	Lithium, Premarin	NONE	Allergy-Medrol Dosepack, Prednisone		U1998005960	1						2	Back pain; Chest pain; Dyspnoea; Hypertonia; Myalgia; Nausea; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~0975800~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1278E~1~IM~RA~PNEUMO (PNEUMOVAX)~2|TD~LEDERLE LABORATORIES~4978200~1~IM~LA~TD ADSORBED (NO BRAND NAME)~2	USA		Influenza
0158872	08/17/2000		68.0			M		This pt developed rhabdomyolysis and subsequent acute renal failure after receiving an influenza virus vax while being treated with cerivastatin and bezafibrate for hyperlipidaemia.  He began experiencing myalgia within 24 hours post vax. The man was admitted to the hospital with extreme weakness and diffuse muscle pain 5 days post vax. He was treated with forced diuresis and urinary alkalisation. During days following admission, his renal function returned to normal. The combined use of statins and fibrates is associated with risk of muscle injury.					Y	5			U				Urine - positive orthotoluidine test, CPK 93,000 U/L, Serum creatinine 3.5 mg/dl, urea level 149 mg/dl, potassium 5.2 mEq/L, urine myoglobin 18,600 ug/L serum myoglobin 43,400 ug/L.	OTH	OTH	Bezafibrate, Cerivastatin	hyperlipidaemia	UNK		FLU240050800	1						2	Asthenia; Blood creatine phosphokinase increased; Blood creatinine increased; Blood potassium increased; Blood urea increased; Laboratory test abnormal; Myalgia; Renal impairment; Rhabdomyolysis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0117943	08/21/2000	WI	50.0	50		M	08/16/2000	A nurse reported that, a 50 year old male received injections of Pne-Imune 23 and ('98-'99) formula influenza virus vaccine, on 12/9/98. Within 8 hours, he experienced malaise, flu-like symptoms and pre-syncope. He was hospitalized. There was no reaction at either injection site. The pt was treated with IV vancomycin and cefepime. He was discharged after 3 days, to complete Augmentin therapy at home. The physician stated, I think it highly unlikely that the vaccine was the cause of the bacteremia, although the temporal association between the vaccine and the illness is extremely unusual. From additional information received on 10/22/99, it was reported, Reviewed, no additional information at this time. Upon Medical review on 8/8/00, this report has been reclassified as serious unlabeled.			Y		Y	3			U	12/09/1998	12/09/1998	0	Blood cultures-positive for S pneumoniae. CXR-no obvious infiltrate or consolidation; there was a question of a left lingular infiltrate.	PVT	OTH	beclomethasone inhaler, Serevent inhaler, albuterol inhaler, glyburide, vitamin B, C, and E.	NONE	Bone marrow transplant 1995, leukocyte infusion 1996, non-insulin dependent diabetes mellitus, COPD, GERD, cervical disc disease, IgG multiple myeloma with spinal lesions.		U1999007190	1						3	Bacterial infection; Dizziness; Influenza like illness; Malaise; Pneumonia	FLU3~CONNAUGHT LABORATORIES~02198P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~PFIZER\WYETH~456690~UNK~IM~LA~PNEUMO (PNU-IMUNE)~3	USA	Life Threatening,Hospitalisation	Influenza
0158998	08/21/2000	MA	45.0			F	08/16/2000	Post vax, this pt experienced numbness around lips and facial area, dizziness, lightheadedness, weakness of extremities resulting in collapsing without loss of consciousness at 8:47 AM. Then the pt experienced burning of the throat and chest at 10:00 AM. She was evaluated in the ER and treated with Benadryl-Solu-Medrol and Epinephrine. She was admitted to ICU for observation and discharged on 10/08/99.				Y	Y	2			Y	10/06/1999	10/06/1999	0		OTH	OTH	Allegra	NONE	Allergic to chemicals and pesticides		U1999007290	1						1	Chest pain; Dizziness; Fall; Hypoaesthesia; Muscular weakness; Pharyngolaryngeal pain	FLU3~CONNAUGHT LABORATORIES~U0107AA~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0127997	08/28/2000	KS	61.0	61		F	09/28/1999	On 10/13/98, the pt developed a fever of 102, headache, sleepiness, redness, swelling and pain at the site of Pnu-Immune vax. She recovered after 2 or 3 days.				Y					Y	10/08/1998	10/13/1998	5	UNK	PUB	PUB	UNK	NONE			FLU1020999	1						3	Headache; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia; Somnolence	FLU3~PARKDALE PHARMACEUTICALS~01998P~6~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~3|PPV~PFIZER\WYETH~454378~2~IM~RA~PNEUMO (PNU-IMUNE)~3	USA	Emergency room visit	Influenza
0129352	08/28/2000	TN	27.0	27		F	10/11/1999	Post vax, the pt complained of right arm redness and swelling 5  to 3.5 .				Y					N	10/08/1999	10/08/1999	0	NONE	PVT	PVT	Birth control pills	NONE	Allergic to codeine		FLU1041099	1						2	Injection site hypersensitivity; Injection site oedema	FLU3~PARKDALE PHARMACEUTICALS~03279P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~PFIZER\WYETH~~1~~LA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0130963	08/28/2000	VA	57.0	57		F	10/12/1999	The nurse reported pt complained of pain, redness, and hot arm that lasted for 4 days. The pt recovered.									Y	10/01/1999	10/02/1999	1	UNK	PVT	OTH	UNK	UNK	UNK		FLU1061099	1						2	Pain; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~01889P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0130964	08/28/2000	TX	40.0	40		F	10/13/1999	Reported arm red and warm to touch (local area only) and feeling as if she were coming down with the flu-lasting approximately 3-4 days. Pt stated arm was fire engine red and hot and felt chills over rest of her body.									Y	10/01/1999	10/02/1999	1	NONE	PVT	PVT	NONE	NONE	NONE		FLU1071099	1						2	Chills; Influenza; Injection site hypersensitivity; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~03079P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0130965	08/28/2000	OH	53.0	53		F	10/13/1999	One of four people exhibiting varying reactions to flu IZ, redness, edema, warmth, and pain shooting up shoulder and down arm.									Y	10/06/1999	10/06/1999	0	UNK	OTH	OTH	UNK	NONE	UNK		FLU1081099	1						2	Oedema; Pain; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02779P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0130966	08/28/2000	OH	48.0	48		F	11/04/1999	Reported by school nurse varying reactions to flu IZ, redness, edema, warmth, and pain shooting up shoulder and down arm.									U	10/06/1999	10/06/1999	0	UNK	OTH	OTH	NONE	NONE	NONE		FLU1091099	1						2	Oedema; Pain; Vasodilatation; Oedema; Pain; Rash; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02779P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2|FLU3~PARKDALE PHARMACEUTICALS~02779P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~4	USA		Influenza
0130966	08/28/2000	OH	48.0	48		F	11/08/1999	The pt experienced redness, edema, warmth and pain shooting up shoulder and down arm. Erythema from 15-25 mm.									U	10/06/1999	10/06/1999	0	UNK	OTH	OTH	UNK	NONE	NONE		FLU1171199	1						4	Oedema; Pain; Vasodilatation; Oedema; Pain; Rash; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02779P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2|FLU3~PARKDALE PHARMACEUTICALS~02779P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~4	USA		Influenza
0130967	08/28/2000	OH	49.0	49		F	11/04/1999	School nurse reported varying reactions to the flu IZ-redness, edema, warmth, and pain shooting up shoulder and down arm.									U	10/06/1999	10/06/1999	0	UNK	OTH	OTH	UNK	NONE	NONE		FLU1101199	1						2	Oedema; Pain; Vasodilatation; Oedema; Pain; Rash; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02779P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2|FLU3~PARKDALE PHARMACEUTICALS~02779P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~4	USA		Influenza
0130967	08/28/2000	OH	49.0	49		F	11/08/1999	The pt experienced varying reactions to the flu immunization which included redness, edema, warmth and pain shooting up shoulder and down arm. An erythema from 15-25 m was experienced.									U	10/06/1999	10/06/1999	0	UNK	OTH	OTH	UNK	NONE	NONE		FLU1161199	1						4	Oedema; Pain; Vasodilatation; Oedema; Pain; Rash; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02779P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2|FLU3~PARKDALE PHARMACEUTICALS~02779P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~4	USA		Influenza
0130968	08/28/2000	OH	53.0	53		M	11/05/1999	The pt had varying reactions including redness, edema, warmth and pain shooting up shoulder and down arm. Erythema from 15m  - 25mm.									U	10/06/1999	10/06/1999	0	UNK	OTH	UNK	UNK	NONE	NONE		FLU1111199	1						2	Oedema; Pain; Rash; Vasodilatation	FLU3~PARKDALE PHARMACEUTICALS~02779P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0130971	08/28/2000	CA	47.0	47		F	11/10/1999	The pt experienced stinging in the right arm crease, red raised area at injection site. The pt went home  and hours after the injection complained of skin sweaty, nauseated, sleepy, tired, headache, vision doubled, and a fever. He reportedly drank 15 or more glasses of water Wednesday nght with sweats and extremem arm soreness, weakness in arm and under arm pain and tenderness.									Y	10/13/1999	10/13/1999	0	NONE	PVT	PVT	NONE	NONE	NONE		FLU2021199	1						2	Asthenia; Diplopia; Headache; Hyperhidrosis; Injection site hypersensitivity; Injection site mass; Myasthenic syndrome; Nausea; Pain; Paraesthesia; Pyrexia; Somnolence; Thirst	FLU3~PARKDALE PHARMACEUTICALS~03179P~1~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~MERCK & CO. INC.~1339H~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0130972	08/28/2000	CA	47.0	47		F	11/10/1999	The same day of vax, the pt experienced nausea, lethargy, headache, tired and a fever. Early the following morning, the pt experienced vomiting and had 3 red raised 7-8 inch long sites that were 5-6 inches across under the arm and the whole upper arm was tender to the touch wit heaviness and major discomfort. The following day, the pt could not work for 2 days due to adverse reactions.									Y	10/13/1999	10/13/1999	0	NONE	PVT	PVT	verapamil, Prozac, Premarin	NONE	hay fever, migraines		FLU2031199	1						2	Asthenia; Headache; Myasthenic syndrome; Nausea; Pain; Pyrexia; Rash maculo-papular; Somnolence; Vomiting	FLU3~PARKDALE PHARMACEUTICALS~03179P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~MERCK & CO. INC.~1339H~1~IM~LA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0130973	08/28/2000	CA	58.0	58		M	11/11/1999	The pt experienced swelling of the left arm to 2 times the normal size, heaviness, restless during the night, fever, headache, all over lousy feeling, loss of appetite, and very painful left arm.									N	10/13/1999	10/13/1999	0	NONE	PVT	OTH	Prilosec, verapamil	NONE	NONE		FLU2041199	1						2	Anorexia; Headache; Malaise; Myasthenic syndrome; Nervousness; Oedema peripheral; Pain; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~03179P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~MERCK & CO. INC.~1339H~1~IM~LA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0130974	08/28/2000	NC				F	11/11/1999	Within 7-8 hours post vax, the pt had sudden onset of symptoms. The pt complained of diffuse myalgias and arthralgias, most prominent in the low back and thighs. She had no chills, no fever, no rash, nausea or vomiting. The provider feel this was consistent with a systemic no-allergic reaction to the flu vaccine.				Y					U	10/15/1999	10/15/1999	0	UNK	UNK	UNK	UNK	UNK	UNK		FLU2051199	1						2	Arthralgia; Myalgia; Injection site pain	FLU3~PARKDALE PHARMACEUTICALS~1889P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2|FLU3~PARKDALE PHARMACEUTICALS~02879P~1~~~INFLUENZA (SEASONAL) (FLUOGEN)~3	USA	Emergency room visit	Influenza
0130975	08/28/2000					U	11/11/1999	Reported an literature article meningoencaphalitis.				Y					U				UNK	UNK	UNK	UNK	UNK	UNK		FLU2071199	1						2	Encephalitis	FLU3~PARKDALE PHARMACEUTICALS~~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0130977	08/28/2000	TX	33.0	33		F	11/12/1999	The pt experienced a severe reaction with itching, wheals all over trunk, and back. The pt went to the ER where he was given Adrenalin.				Y					Y	10/18/1999	10/18/1999	0	NONE	PVT	PVT	NONE	NONE	NONE		FLU2091199	1						2	Pruritus; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~03079P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0130979	08/28/2000	OK	42.0	41		M	11/15/1999	Reported shooting pain left arm-when raise arm and cannot lay on arm. Continue to take Motrin. Pain lasted for 4 days.				Y					Y	10/12/1999	10/12/1999	0	NONE	PVT	OTH	Zoloft, vitamins	NONE	NONE		FLU2131199	1						2	Hypokinesia; Pain	FLU3~PARKDALE PHARMACEUTICALS~02799P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Emergency room visit	Influenza
0130982	08/28/2000	NY				F	11/16/1999	The pt reported fluogen was given and within 72 hours the left arm was edematous from the upper shoulder to the elbow.									Y	10/14/1999	10/18/1999	4	NONE	PVT	OTH	NONE	NONE	NONE		FLU2161199	1						2	Oedema peripheral	FLU3~PARKDALE PHARMACEUTICALS~02979P~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0130983	08/28/2000	FL	48.0	48		M	11/16/1999	Technician was drawing up fluogen and wiped eyes during the process-topical exposure. The technician had a reaction within 15 minutes-pupils were red, dilated and painful. The technician recovered after 12 hours.									Y	10/29/1999	10/29/1999	0	NONE	PVT	OTH	UNK	UNK	UNK		FLU2171199	1						2	Conjunctivitis; Eye pain; Mydriasis	FLU3~PARKDALE PHARMACEUTICALS~02189P~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0130984	08/28/2000	IL	93.0	93		F	11/17/1999	The pt had an allergic reaction and felt tired and weak. Went to the ER and was hospitalized for a couple of days.				Y	Y	2			Y	10/15/1999	10/16/1999	1	WBC, liver enzyme, bilirubin, SGOT - all increased	PVT	OTH	UNK	NONE	NONE		FLU2181199	1						2	Aspartate aminotransferase increased; Asthenia; Hepatic function abnormal; Hyperbilirubinaemia; Hypersensitivity; Leukocytosis	FLU3~PARKDALE PHARMACEUTICALS~~1~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Hospitalisation	Influenza
0159176	08/28/2000	MI	66.0	66		M	08/24/2000	Post vax, the pt developed cellulitis. The pt was hospitalized				Y	Y				U	11/04/1999			UNK	PVT	OTH	albuterol, Celecoxib, Flovent, Hyzaar, Prilosec, Serevent	UNK	Atrial fibrillation, COPD, gastritis (NOS), hypertension (NOS), osteoarthritis (NOS)		HQ5704115NOV1999	1						1	Cellulitis	FLU3~PFIZER\WYETH~4998216~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~466445~UNK~~RA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0159214	08/29/2000	CT	74.0	72		F	08/21/2000	In May, 1999, the pt received her 2nd Lymerix. At the end of November, 1999, she developed a red, flat, itchy rash on the lateral aspect of the left lower leg that spread downwards and then across the anterior foot. She treated the rash with hydrocortisone acetate and the rash resolved in 7 days. She did not consult a physician about this. Subsequently, once the rash had resolved, she had muscle aching all over the right leg. In early 12/99, she reported that she had muscle pain in her arms, neck and back. She reported that her lungs ached when she took a breath. The pain in the right leg continued also. She was seen by her MD and admitted to the hospital in December, 1999, for flu. She reported that her oxygen level decreased to 62% and that she was told she had a lung infection. She was hospitalized for 3 days and treated with IV antibiotics (NOS). Pt stated that the Lymerix caused this to happen, I know that now. From 1/00 to 4/00, the pt continued to experience muscle pains in her arms, neck and back, especially on the left side. In 4/00, she had the 3rd dose of Lymerix as she did not make a connection between the muscle pain and Lymerix. She was seen by a rheumatologist in 6/00 and reported that no arthritis was found. On 8/8/00, she developed a sinus infection. For her muscle pain, MD prescribed Flexeril. Pt used for only 1 day because it was too strong for her to function. The pt stated I can't function with this pain. As on 8/15/00, the outcome of the event is ongoing.				Y	Y	3			N	05/01/1999	11/30/1999	213		PVT	OTH	Diovan, Synthroid, atenolol		allergic to grass, mold, PCN, bilateral thumb arthritis, hypertension, hyperthyroidism, rapid heartbeats		20000250141	1						1	Chest pain; Hypoxia; Influenza; Myalgia; Rash pruritic; Respiratory tract infection; Sinusitis	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|LYME~SMITHKLINE BEECHAM~~2~IM~LA~LYME (LYMERIX)~1	USA	Hospitalisation	Influenza
0159478	09/08/2000	CA	51.0			F		One day post vax, the pt developed whole body spasms and felt she could not walk, which lasted for less than 1 year. She also reported that her ears had become sensitive to vibration and her eyes were sensitive. These symptoms were mostly resolved except for panic attacks. On 10/98 she received a second flu vaccine and the next day experienced similar episode of body spasm and panicky feeling.									U	10/01/1998	10/02/1998	1		OTH	OTH	midazolam		pancreatitis, allergy to PCN and sulfa, hyperparathyroidism		MPU2000004520	1						1	Difficulty in walking; Ear disorder; Eye disorder; Muscle spasms; Panic reaction	FLUX~UNKNOWN MANUFACTURER~~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0159723	09/15/2000	FL				F	06/29/2000	Post vax, the pt developed an injection site reaction characterized by a large area of redness and itching. She recovered.									Y				UNK	OTH	OTH	UNK	UNK	UNK	injection site reaction~Influenza (Seasonal) (FluShield)~1~0.00~In Patient	HQ6778502JUN2000	1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0159724	09/15/2000	CA	60.0			F	08/08/2000	A female reported that she received an injection of 1995-96 formula influenza virus vaccine (manufacturer unknown) and immediately experienced a headache. She recovered. The pt reported undergoing a thyroidectomy in 1966 and reported experiencing viral inf. attack on my nervous system in 1984.									Y				UNK	OTH	OTH	UNK	UNK	Thyroidectomy NOS; Viral infection NOS		HQ8219806JUL2000	1						1	Headache; Atrial flutter; Headache; Hypoaesthesia oral; Pain in jaw	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0159725	09/15/2000	ME				F	01/04/2000	A physician reported that a female received an injection of influenza virus vaccine (manufacturer unknown), 4 years ago and subsequently, developed severe neurological problems. No further information was available at the date of this report.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ4630204NOV1999	1						1	Neuropathy	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0159726	09/15/2000	NJ				U		Post vax, the pt experienced an unspecified adverse event. The reporter indicated that 5 pts experienced an adverse event following receipt of flu vax, however they were not identifiable. No further information was provided.									U				UNK	OTH	OTH	UNK	UNK	UNK		898313024A	1						1	Unevaluable event	FLUX~PFIZER\WYETH~4928234~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0159727	09/15/2000	PA	64.0			F	08/07/2000	A female, now 72 years of age, reported that she received an injection of 1992-93 formula influenza virus vaccine (manufacturer unknown) and subsequently, developed a bad generalized rash. The rash was dx'd as an allergic reaction. The pt recovered.									Y				UNK	PVT	PVT	levothyroxine, unspecified antihypertensive	NONE	History of intolerance to scallops; fibromyalgia syndrome		HQ5786412MAY2000	1						1	Hypersensitivity; Rash	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0159728	09/15/2000	VA				F		A pharmacist reported that a female developed urticaria following receipt of flu vax. She recovered. No further information was available at the date of this report.									Y				UNK	OTH	OTH	UNK	UNK	UNK		898345099A	1						1	Urticaria	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0159729	09/15/2000	MD				U	04/26/2000	A physician reported that a pt developed shortness of breath following receipt of flu vax 10 to 12 years ago. A dx of allergic reaction was made. The pt recovered. No further information was available at the date of this report.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ0467813JAN2000	1						1	Dyspnoea; Hypersensitivity	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0159730	09/15/2000	FL				M	01/24/2000	The wife of the pt reported that her husband received the flu vax 5 to 6 years ago and subsequently developed fever, chills, aches, nausea, and vomiting. He was deathly ill for 2 weeks. The reporter declined to provide additional information and declined to grant permission for follow-up investigation.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ3184122OCT1999	1						1	Nausea; Pain; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0159731	09/15/2000					F	01/24/2000	A company representative reported that a female received an injection of flu vax in 1993 and subsequently developed hives. She recovered. No further information was available at the date of this report.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ8322113DEC1999	1						1	Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0159732	09/15/2000	OK	53.0			F		A nurse reported that a female received a flu vax approximately 2 years ago and subsequently became very ill with flu-like symptoms. The pt stated that she may be allergic to eggs. No further information was available at the date of this report.									U				UNK	OTH	OTH	UNK	UNK	allergic to corn and possibly eggs		899244089A	1						1	Influenza like illness	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0159733	09/15/2000	FL	67.0			F	06/29/2000	Post vax, the pt developed an injection site reaction characterized by a large area of redness and itching. She recovered.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ6778402JUN2000	1						1	Injection site erythema; Pruritus	FLU3~PFIZER\WYETH~~3~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0159734	09/15/2000	CA				F	08/08/2000	Immediately post vax, the pt developed a headache. She recovered.									Y				UNK	OTH	OTH	UNK	UNK	thyroidectomy,viral infection	headache~Influenza (Seasonal) (no brand name)~~0.00~In Patient	HQ8219706JUL2000	1						1	Headache	FLU3~PFIZER\WYETH~~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0159735	09/15/2000	MA				M		A pharmacist reported that in 1996, he received an injection of flu vax and subsequently developed an injection site reaction. The pt recovered.									Y				UNK	OTH	OTH	UNK	UNK	UNK		899200102A	1						1	Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0159736	09/15/2000	TX	65.0			M	02/14/2000	Pt received flu vax in 1995. Six weeks following IZ, the pt developed right brachial neuritis. The pt recovered within 6 months.									Y				UNK	OTH	OTH	NONE	NONE	UNK		HQ0902903FEB2000	1						1	Neuropathy peripheral	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0159737	09/15/2000	FL				F	06/29/2000	Post vax, the pt developed an injection site reaction characterized by a large area of redness and itching. She recovered.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ7287214JUN2000	1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0159749	09/15/2000	VA				M	10/20/1999	A male reported that he received an injection of 1996-97 formula influenza virus vaccine in 1996. Immediately following vaccination, the patient developed severe hives from scalp to soles of feet. The patient was administered an injection of Benadryl and recovered. This event is considered medically important (OMIC).									Y					PUB	OTH	UNK				HQ2562114OCT1999	1						1	Urticaria	FLU3~PFIZER\WYETH~~UNK~~UN~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0159917	09/20/2000	CA	32.0	31		M	05/11/2000	Pt experienced headaches, nausea, memory loss, and dx with viral encephalitis.				Y	Y	3			Y	10/24/1999	10/27/1999	3	CT scan of head and labs	MIL	MIL	NONE	NONE				1						1	Amnesia; Encephalitis; Headache; Nausea	FLU3~CONNAUGHT LABORATORIES~U0135AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0159923	09/20/2000	OR	48.0	48		M	06/20/2000	Approximately 24 hours, post vax, pt developed severe local inflammation and fever to 102F, lasting several days, then subsiding. Also, got tinnitis in left ear which has persisted.									Y	10/16/1999	10/16/1999	0		MIL	MIL	naproxen x 9 months					1						1	Injection site inflammation; Pyrexia; Tinnitus	ANTH~MICHIGAN DEPT PUB HLTH~~3~SC~~ANTHRAX (NO BRAND NAME)~1|FLU3~CONNAUGHT LABORATORIES~U0135AA~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0159930	09/20/2000	CA				M	11/13/1999	Left arm soreness and swelling the next day, post vax. Continued soreness and swelling for 4 weeks, but is better. Had flu symptoms next day (ill X 2 weeks). Treated with antibiotics for infection.									Y					MIL	MIL	NONE	NONE	NONE			1						1	Infection; Influenza like illness; Injection site pain; Injection site swelling	ANTH~MICHIGAN DEPT PUB HLTH~FAV024~3~SC~LA~ANTHRAX (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~U0138AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0160110	09/26/2000	NY	74.0			F	09/22/2000	Swelling of lips, hives on breast and within 36 hours, generalized hives. On 9/21/00, pt came in with above symptoms. Treated with Solu-Medrol and Benadryl.									N		09/20/2000			PVT	PVT	Celebrex, Xanax		HTN, right bundle branch block, anxiety, arthritis			1						1	Swelling face; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E64351BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0130754	09/28/2000	OH	30.0	29		M	09/08/2000	My reaction was rather swift. On the eve of 10/27, I had a bothersome restlessness in my legs, but attributed it to being tired. This went away that night but returned the next 2 evenings. By Friday, I was experiencing the restlessness during the day at my desk at work as well. I took off work at lunch on Friday and went to the lumber store and while there felt a little lethargic and noticed that squatting required a little effort. That night sleep was a long time coming as I was tired enough that I should have been able to drop off immediately, but my legs were actually jumping off the bed and keeping me awake. After watching a video, to take my mind off the electrical impulses building in my legs, I went to bed again and eventually drifted to sleep. I awoke feeling even more lethargic, with minor lower back pain/ache and my legs now felt a little heavy. I felt like I was getting the flu. Something strange I noticed that my feet tingled a little. That night I tried to jog across the parking lot for something I'd left in the truck, but my legs were rubbery and my feet felt like I was running on bowls of jello. It was so weird; I thought I was going to fall, but managed to stop without doing so. That night in bed, my legs convulsed worse than the the night before. The next morning, my legs felt like 2 huge sausages as I stumbled forward, then backward to rest on the edge of the bed. After a few seconds rest, I was able to shuffle to the bathroom where a more interesting phenomenon awaited me. The 5 minute wait for urination had become an exercise in leg-jumping every time I attempted to urinate, my leg would jump instead. This apparent cross-signaling panicked me, so I called my MD and was ordered to report to ER, immediately. I asked my wife to drive me there as I didn't think I could drive myself. I walked into ER under my own power, but over the course of the afternoon, I gradually lost sensation and motor ability. The paralysis gradually worked it's way up my legs and torso to stop just above my nipple level. Breathing became more difficult and my first 24 hours in ICU were spent waiting to see if I'd go on a ventilator. Today I'm a T1 level paraplegic, dx'd with transverse myelitis. I also have a decubitis ulcer and have shoulder cramps. Admitted to hospital 10/31/99 and discharged on 11/17/99. He had idiopathic thrombocytopenic purpura, autoimmune neutropenia and s/p splenectomy with anemia. The pt has developed a UTI. He was started on Cipro 500 mg.				Y				Y	N	10/26/1999	10/27/1999	1	CT and dorsal myelogram done on 11/2/99. Spinal tap done on 11/11/99. MRI of brain-nml on 11/8/99. MRI of cervical spine shows an intermedullary increased signal intensity from C5 to T1. This was consistent with either demyelinating disease or multiple sclerosis. HIB test-neg. EKG-sinus rhythm with premature atrial contractions and left ventricular hypertrophy.	OTH	OTH	Prednisone, Folic Acid, Vitamin E, Vitamin C, vancomycin	NONE	Allergy to PCN		24120900	1						2	Arrhythmia supraventricular; Back pain; Coordination abnormal; Dyspnoea; Hyperkinesia; Hypertrophy; Hypokinesia; Insomnia; Leukopenia; Multiple sclerosis; Muscle twitching; Myasthenic syndrome; Myelitis; Neuropathy; Paraplegia; Skin ulcer; Somnolence; Thrombocytopenic purpura; Urinary tract infection	FLU3~PARKDALE PHARMACEUTICALS~02879P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA	Disabling	Influenza
0160205	09/29/2000	AZ	33.0	33		M	11/22/1999	Post vax, the pt developed progressive ascending numbness/tingling of extremities, paralysis of left face and lower extremities. Dx with Guillain-Barre syndrome.				Y	Y	6		Y	U	10/24/1999	11/06/1999	13	CT of brain - nml, WBC - 8.9, HGB - 14.8, platelets - 234000, CSF protein, - 150, plasmapheresis, CSF tap	UNK	UNK	None	None	seasonal allergies, allergy to Erythromycin			1						1	CSF test abnormal; Facial palsy; Guillain-Barre syndrome; Hypoaesthesia	FLU3~PARKDALE PHARMACEUTICALS~03279P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation,Disabling	Influenza
0160258	10/03/2000	AZ	33.0	33		M	11/22/1999	Post vax, the pt developed progressive ascending numbness/tingling of extremities. Paralysis of left face and lower extremities. Dx with Guillain Barre syndrome.					Y			Y	N	10/24/1999	11/06/1999	13	CT of brain-nml, WBC-8.9, HGB-14.8, platlets-284,000, CSF protein-150	UNK	UNK			seasonal allergies, hypertension			1						1	Facial palsy; Guillain-Barre syndrome; Hypoaesthesia	FLU3~PARKDALE PHARMACEUTICALS~03279P~1~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Hospitalisation,Disabling	Influenza
0160295	10/04/2000	OH	87.0	87		F	09/25/2000	The pt experienced weakness, falling, ataxia with incontinence, chills, body aches, neck and shoulder pain.				Y					N	09/18/2000	09/21/2000	3	CT head, neg, WBC - 11.6, CMP - Bun 27, HIH, AST	PVT	PVT	Vasotec, Lasix, ASA	tooth infection	hypertension, gout, diabetes			1						1	Arthralgia; Chills; Coordination abnormal; Fall; Muscular weakness; Pain; Urinary incontinence	FLU3~MEDEVA PHARMA, LTD.~E61760GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0151797	10/05/2000	FL	53.0	53		F	05/04/2000	Pt reported nodules on both legs and arms after vax. She reported biopsy was and blood work test performed normal. 3/23/00 F/U: Pt reported the nodules on her body has almost disappeared. She reported that the doctors has not been able to role out if it caused by the Fluogen 5/23/2000.									Y	11/19/1999	12/14/1999	25	Blood work - neg.	PVT	PVT	Vaseretic	NONE	NONE		FLU24040500	1						2	Lymphoma; Subcutaneous nodule; Skin nodule	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PARKDALE PHARMACEUTICALS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2	USA		Influenza
0161664	10/05/2000	AR				F	05/27/2000	Red wheel, hot area about 4 cm around injection site. The reaction lasted for 2 days.									Y	01/08/2000	01/08/2000	0	NONE	PVT	PVT	NONE	NONE	NONE		FLU224100500	1						1	Injection site erythema; Injection site warmth; Urticaria	FLU3~PARKDALE PHARMACEUTICALS~00399P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0129891	10/06/2000	NY	70.0	70		F	04/04/2000	A nurse reported that a 70 year old female received Pnu-Imune 23 and Flu Shield (1999-2000) on 10/20/99. Later that evening, she developed an injection site reaction at the site of the Pnu-Imune 23 site, characterized by erythema and swelling which extended to the elbow. Cellulitis was ruled out and the pt was treated with Benadryl. She recovered.									Y	10/20/1999	10/20/1999	0	UNK	PVT	OTH	NONE	NONE	Drug hypersensitivity; scoliosis		HQ3424125OCT1999	1						2	Injection site erythema; Injection site swelling	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~463729~1~IM~LA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0129986	10/06/2000	IN	42.0	42		F	11/11/1999	A nurse reported that a pt received an injection of Pnu-Imune 23 and Fluogen (Park-Davis) vaccines on 10/5/99 and subsequently, developed on injection site reaction, at the site of the Pnu-Imune 23 administration, characterized by more redness and swelling than usual. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune 23. Additional information received from the physician on 11/5/99, indicated that this pt is a 42 year old female who is allergic to generic Synthroid.									U	10/05/1999	10/05/1999	0	UNK	PVT	PVT	Synthroid, Zoloft	NONE	Hypersensitivity NOS, Hypothyroidism		HQ2426114OCT1999	1						2	Injection site erythema; Injection site swelling	FLU3~PARKDALE PHARMACEUTICALS~02779P~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~PFIZER\WYETH~458743~1~IM~RA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0130239	10/06/2000	NY	19.0	19		F	04/04/2000	A physician reported that a 19 year old female received Pnu-Imune 23 and 1999-2000 formula influenza virus vaccines on 10/25/99. Approx. 6 hours, post vax, she developed an injection site reaction characterized by warmth and swelling at the site of Pnu-Imune 23 administration; the reaction resulted in a decrease in range of motion. The pt recovered.									Y	10/25/1999	10/25/1999	0	UNK	OTH	OTH	NONE	NONE	Pulmonary hypertension NOS; Pulmonary valve incompetence; Fallot's tetralogy		HQ3920328OCT1999	1						2	Hypokinesia; Injection site reaction; Injection site swelling; Injection site warmth	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~~UNK~IM~RA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0131862	10/06/2000	AR				F	04/21/2000	On Nov 6, 1999 pt developed urticaria, erythema and induration at the injection site. She was treated with Benadryl and recovered. This is 1 of 10 residents from this facility who had adverse experience following receipt of 2 different lots of vax.									Y	11/04/1999	11/06/1999	2	UNK	OTH	PUB	Aspirin Bayer Atenolol	UNK	UNK		HQ9210321DEC1999	1						2	Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0131863	10/06/2000	AR	88.0	88		F	03/03/2000	On Nov. 6, 1999, she developed an injection site reaction characterized by urticaria, erythema, and induration. She was treated with Benadryl 25 mg orally, every 4 hours and recovered. This is 1 of 10 residents from this facility who had an adverse experience following receipt of 2 different lots of PNU-Immune. This report was received from PMC U1999009800									Y	11/04/1999	11/06/1999	2	UNK	OTH	PUB	UNK	UNK	UNK		HQ9196121DEC1999	1						2	Injection site hypersensitivity; Injection site mass; Injection site erythema; Injection site induration; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~2|FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~3	USA		Influenza
0131864	10/06/2000	AR	78.0	78		F	03/03/2000	On November 5, 1999, she developed an injection site reaction characterized by an 8 cm by 10 cm area of redness, urticaria, and induration and a fever. She was treated with Benadryl 25 mg orally, every 4 hours. She recovered on Nov. 09,1999. This is 1 of 10 residents from this facility who had an adverse experience following receipt of 2 different lots of Pnu-Imune. This report was received from PMC U1999-009630.									Y	11/04/1999	11/05/1999	1	UNK	OTH	PUB	UNK	UNK	UNK		HQ8660115DEC1999	1						2	Injection site hypersensitivity; Injection site mass; Pyrexia; Erythema; Injection site erythema; Injection site induration; Pyrexia; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~2|FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~3	USA		Influenza
0131865	10/06/2000	AZ	88.0			F	02/07/2000	A nurse reported that an 88 year old female received Pnu-Imune 23, as well as, Fluzone SV (PMC USA) vaccines mixed in a single syringe on 11/4/99. On 11/6/99, the pt developed urticaria, erythema and induration. The pt was treated with Benadryl; she recovered. Additional information received from the physician on 1/26/00, indicated that the pt remained recovered.									Y		11/06/1999		UNK	OTH	PUB	UNK	UNK	UNK		HQ8514114DEC1999	1						2	Injection site hypersensitivity; Injection site mass; Urticaria; Injection site erythema; Injection site induration; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~2|FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~3	USA		Influenza
0131927	10/06/2000	AR	81.0	80		F	03/03/2000	The pt received Pnu-Imune and Fluzone mixed in the same syringe. Two days later she developed an injection site reaction characterized by erythema, urticaria, and induration. She was treated with Benadryl every four hours and recovered.									Y	11/04/1999	11/06/1999	2	UNK	OTH	PUB	UNK	UNK	UNK		HQ9190121DEC1999	1						2	Injection site hypersensitivity; Injection site mass; Injection site erythema; Injection site induration; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~2|FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~3	USA		Influenza
0131973	10/06/2000	AR				F	03/03/2000	A nurse reported that a female resident of a nursing center received Pnu-Imune 23 and Fluzone '99-'00 vaccines mixed in the same syringe on 11/4/99. On 11/6/99, she developed urticaria, erythema and an induration at the injection site. She was treated with oral Benadryl 25mg every 4 hours. She recovered on 11/9/99. This is 1 of 10 residents from this facility who had an adverse experience following receipt of 2 different lots of Pnu-Imune.									Y		11/06/1999		UNK	OTH	PVT	Prenatal vitamins and risperidone penactin	UNK	UNK		HQ7716207DEC1999	1						2	Injection site hypersensitivity; Injection site mass; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~466440~UNK~IM~RA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0131976	10/06/2000	AR	93.0			F	03/03/2000	A nurse reported that a 93 year old female received Pnu-Imune 23 and Fluzone '99-'00 vaccines mixed in the same syringe on 11/4/99. On 11/6/99, she developed an injection site reaction characterized by erythema, urticaria and an induration. She was treated with Benadryl 25mg orally, every 4 hours. She recovered on 11/7/99. This is 1 of 10 residents from this facility who had an adverse experience following receipt of 2 different lots of Pnu-Imune.									Y		11/06/1999		UNK	OTH	PUB	Zoloft	UNK	UNK		HQ8688115DEC1999	1						2	Injection site hypersensitivity; Injection site mass; Urticaria; Injection site erythema; Injection site induration; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~2|FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~3	USA		Influenza
0131977	10/06/2000	AR	72.0			F	03/03/2000	A nurse reported that a 72 year old female received Pnu-Imune 23 and Fluzone '99-'00 vaccines mixed in the same syringe on 11/4/99. On 11/6/99, she developed an injection site reaction characterized by a 6cm X 8cm area of redness, itching, urticaria and induration. She was treated with Benadryl 25mg orally every 4 hours. She recovered on 11/9/99. This is 1 of 10 residents from this facility who had an adverse experience following receipt of 2 different lots of Pnu-Imune.									Y		11/06/1999		UNK	OTH	PUB	TNG Lasix, risperidone, Megace	UNK	UNK		HQ8526214DEC1999	1						2	Injection site hypersensitivity; Injection site mass; Pruritus; Urticaria; Erythema; Injection site erythema; Injection site induration; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~2|FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~3	USA		Influenza
0131978	10/06/2000	AR				F	03/03/2000	A nurse reported that a female resident of a nursing center received Pnu-Imune 23 and Fluzone '99-'00 vaccines mixed in the same syringe on 11/4/99. On 11/6/99, she developed urticaria, erythema and an induration at the injection site. She was treated with oral Benadryl 25mg every 4 hours. She recovered on 11/9/99. This is 1 of 10 residents from this facility who had an adverse experience following receipt of 2 different lots of Pnu-Imune.									Y		11/06/1999		UNK	OTH	OTH	Synthroid, Catapres, Dyazide, Detrol	UNK	UNK		HQ7698407DEC1999	1						2	Injection site hypersensitivity; Injection site mass; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0161667	10/06/2000	GA	29.0			F	02/04/2000	Immediately post injection, she developed swelling at the injection site. Within 10 hours, her arm was huge and red and she could not use it. After the reaction she developed chronic rhinitis. She was treated with unspecified prescription medicine.									U				UNK	PVT	OTH	Levlen	UNK	UNK		0806129091999	1						1	Injection site erythema; Injection site swelling; Rhinitis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0161671	10/06/2000	IN	50.0	50		F	09/11/2000	At the time of vax, the pt had a chronic cough which persisted following immunization. The pt was prescribed AUGMENTIN and a decongestant and subsequently developed inflammation and neuropathy of the legs. Additional information was received from the vaccine provider on Nov. 4, 1999 and Nov 15, 1999. The vaccine provider indicated that a diagnosis of GUILLIAN-BARRE syndrome had been made. He indicated that the pt had not recovered and was permanently disabled.  Additional information was received from pts neurologist on 01-05-2000.  One week post vax, she experienced pain in her legs, however she could pick up her legs. Neurologists made diagnosis of inflammation and neuropathy of the legs. The pt was treated with a course of oral prednisone therapy and a course of IV immune globulin. The neurologist stated that the pt was not hospitalized; she did not recover, but was not permanently disabled. THis event is considered medically inportant.				Y					N	01/19/1999	01/24/1999	5	05/14/1999 Lumbar puncture 121 mg/dl, 04/28/1999 Antinuclear antibody neg, liver function test wnl, thyroxine wnl, Vitamin B12 wnl, Protein neg,	OTH	OTH	AUGMENTIN; CLARITIN; CYCRIN; ESTRATEST; FLONASE; PRILOSEC	URI, pyelonephritis	Cough		3652426101999	1						1	Cough; Guillain-Barre syndrome; Inflammation; Neuropathy peripheral; Pain	FLU3~PFIZER\WYETH~4988201~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~456693~UNK~IM~UN~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0161697	10/06/2000	ID				U	02/04/2000	Pt developed an injection site reaction characterized by pain, itching and swelling that extended at least to the elbow.									U	09/01/1999			UNK	PVT	OTH	UNK	UNK	UNK		1496206101999	1						1	Injection site hypersensitivity; Injection site swelling; Pain; Pruritus	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~454979~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0161700	10/06/2000	IN				U	10/15/1999	Injection site reaction at the site characterized by more redness and swelling than usual. Concomitant therapy included revacort. This is 1 of 2 pts from this facility who experienced event following receipt of vax.									U	10/05/1999	10/05/1999	0		PVT	PVT					2008111101999	1						1	Injection site erythema; Injection site swelling	FLU3~PARKDALE PHARMACEUTICALS~02779P~2~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~PFIZER\WYETH~~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0161703	10/06/2000	OH	22.0	22		F	08/23/2000	A MA reported that a 23 year old female received an injection of Pnu-Imune 23 and Flu Shield (1999-2000) vaccines on 10/5/99. She, subsequently, developed a fever of 104F, vomiting and arm pain. Additional information received from the physician on 11/19/99, stated that the pt went to the ER on 10/6/99. On 10/7/99, she was seen by the physician who performed a CBC with differential and treated her with IV fluid rehydration. The pt recovered.				Y					Y	10/05/1999	10/06/1999	1	Blood test revealed WBC-increased to 26,000 cells/mm3. Manual differential showed 90% segmented neutrophils-increased, 5% lymphocytes-decreased and 5% monocytes. Erythrocyte sedimentation rate was 45mm/hr.	PVT	OTH	UNK	UNK	Behcet's syndrome		HQ2192312OCT1999	1						1	Dehydration; Injection site pain; Pyrexia; Vomiting; White blood cell count increased	FLU3~PFIZER\WYETH~4998220~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~456693~UNK~SC~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0161708	10/06/2000	NY				M	02/04/2000	A nurse reported that a male pt received an injection of Pnu-Imune 23 and influenza virus vaccines on 10/14/99. That evening, he developed pain and swelling at the injection site so severe that he could not lift his arm. The next day, he developed nausea and a headache. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune lot 459038. The pt's wife experienced this event following receipt of vaccine administration on 10/14/99. See MCN HQ8085310DEC1999.									U	10/14/1999	10/14/1999	0	UNK	PUB	OTH	UNK	NONE	UNK		266861	1						1	Headache; Hypersensitivity; Hypokinesia; Injection site pain; Injection site swelling; Nausea	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~459038~1~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0161710	10/06/2000	UT	51.0	51		F	02/17/2000	A physician reported that a 51 year old female received Pnu-Imune 23 and influenza virus vaccine on 10/15/99. On 10/17/99, the pt developed an injection site reaction characterized by redness, pain which radiated to the shoulder and elbow and an area of swelling described as the size of a baseball. She also developed a low-grade fever of 99.8 to 100.0F. She was treated with ibuprofen and Benadryl. This report was received on 10/18/99; the pt had been stable for 1 day. Additional information received from the provider on 2/14/00, stated that the pt recovered.				Y					Y	10/15/1999	10/17/1999	2	UNK	PVT	OTH	NONE	NONE	Asthma NOS		HQ2800119OCT1999	1						1	Injection site erythema; Injection site pain; Injection site swelling; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~454384~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0161713	10/06/2000	WY	44.0	44		F	02/17/2000	A nurse reported that a 44 year old female received injections of Pnu-Imune 23 and Flu Shield (1999-2000) on 10/13/99. On 10/14/99, she developed an injection site reaction at the site of Pnu-Imune 23 administration characterized by warmth, redness and swelling. She could not lift her arm and was prescribed unspecified treatment. Additional information received on 2/2/00, indicated that the pt recovered.									Y	10/13/1999	10/14/1999	1	NONE	PUB	PUB	Insulin via pump; Parenteral	NONE	Diabetes Mellitus NOS		HQ3204222OCT1999	1						1	Hypokinesia; Injection site erythema; Injection site swelling; Injection site warmth	FLU3~PFIZER\WYETH~4998209~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~459837~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0161798	10/06/2000	MT	57.0	57		M	02/07/2000	A nurse reported that a 57 year old male received injections of Pnu-Imune 23 and Flu Shield (1999-2000) on 10/27/99. Within 24 hours, he developed redness, warmth, swelling and pain at the site of Pnu-Imune 23 administration. The area was treated with anti-inflammatories and applications of ice. As of 10/29/99, the adverse event was reportedly not resolving.									U	10/27/1999	10/28/1999	1	UNK	PVT	OTH	Procardia XL	NONE	UNK		HQ4264102NOV1999	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~PFIZER\WYETH~4998222~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~463021~UNK~SC~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0161799	10/06/2000	VA				U	11/16/1999	A physician reported that a pt received Pnu-Imune 23 and (1999-2000) influenza virus vaccines in 10/99 and subsequently developed a very swollen arm and felt ill, kind of achy all over. This is 1 of 3 pts from this facility to experience this event following receipt of Pnu-Imune 23 lot 466787. The reporter indicated that 3 pts experienced this event; however; they are not presently identifiable. Additional reports will be generated when identifying information is provided.									U	10/01/1999	10/01/1999	0	UNK	PVT	OTH	UNK	UNK	UNK		HQ4614304NOV1999	1						1	Injection site reaction; Injection site swelling; Malaise; Pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~466787~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0161800	10/06/2000	WY	65.0			F	02/17/2000	A physician reported that a female in her 60's received injections of Pnu-Imune 23 and influenza virus vaccine (1998-1999 formula) approx. 1 year ago. She developed constant aching at the site of Pnu-Imune 23 administration that still persists. She reports occasionally being able to palpate a circumscribed mass in the area; however, the physician is unable to confirm this. Follow-up information received from the reporting physician on 2/15/00, provided the vaccine provider and pt's address.				Y					N				UNK	OTH	OTH	Premarin, Synthroid	NONE	Poliomyelitis NEC, Post polio syndrome		HQ4774105NOV1999	1						1	Injection site mass; Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0161803	10/06/2000	KY	59.0	59		F	02/16/2000	On 10/27/99, pt developed paresthesias, weakness and an injection site reaction characterized by a rash and pain that extended down her arm and up into her neck. She recovered from the rash and paresthesia; however, as of 11/5/99, the pain and weakness persisted.									U	10/26/1999	10/27/1999	1	UNK	PVT	OTH	UNK	NONE	UNK		HQ4916208NOV1999	1						1	Asthenia; Injection site pain; Injection site rash; Paraesthesia; Asthenia; Fatigue; Hypoaesthesia; Injection site erythema; Injection site swelling; Injection site warmth; Laboratory test abnormal; Paraesthesia; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~456691~1~IM~~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~4998223~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~456891~UNK~IM~RA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0161803	10/06/2000	KY	59.0	59		F	12/10/1999	A physician reported that a 59 year old female received Pnu-Imune 23 in her right deltoid and Flu Shield in her left deltoid on 10/26/99 and that evening, developed numbness, redness, warmth, swelling and hives of her right arm, neck and shoulder. She also experienced fatigue and weakness. The pt was seen by the physician on 10/28/99 and instructed to apply compresses and elevate her right arm. The pt recovered. Additional information received on 11/30/99 from the physician, indicated that the pt did not recover and continues to experience paresthesia and some grip weakness.				Y					N	10/26/1999	10/26/1999	0	UA-1 red blood cell; Chemistry NOS-neg; X-ray NOS-shoulder was neg; EMG-neg.	PVT	PVT	NONE	NONE	UNK		HQ5254110NOV1999	1						2	Asthenia; Injection site pain; Injection site rash; Paraesthesia; Asthenia; Fatigue; Hypoaesthesia; Injection site erythema; Injection site swelling; Injection site warmth; Laboratory test abnormal; Paraesthesia; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~456691~1~IM~~PNEUMO (PNU-IMUNE)~1|FLU3~PFIZER\WYETH~4998223~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~456891~UNK~IM~RA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0161806	10/06/2000	MI	38.0	38		F	08/23/2000	A 38 year old female received injection of Pnu-Imune 23 and Fluzone (PMC USA) on 10/26/99. On 10/27/99, she developed warmth at the site of Pnu-Imune administration that was described as extremely hot, arthralgia, body aches and an increased heart rate. She recovered.									Y	10/26/1999	10/27/1999	1	UNK	PVT	OTH	UNK	NONE	UNK		HQ5278111NOV1999	1						1	Arthralgia; Heart rate increased; Injection site reaction; Injection site warmth; Pain; Arthralgia; Heart rate increased; Injection site warmth; Pain	FLU3~CONNAUGHT LABORATORIES~U0063AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466443~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1|FLU3~CONNAUGHT LABORATORIES~U0063AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~466443~UNK~IM~LA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0161808	10/06/2000	GA	18.0	18		F	12/13/1999	A nurse reported that an 18 year old female received Pnu-Imune 23 and (1999-2000 formula) influenza virus vaccines on 11/1/99. Within 24 hours, the pt developed an injection site reaction at the Pnu-Imune 23 administration site characterized by a 4cm area of swelling and redness. The pt was treated with Benadryl and applications of ice to the affected area. Additional information received from the physician on 12/7/99, indicated that on 11/4/99, the pt was treated with Rocephin and Keflex for 7 days. The pt remained recovered.				Y					Y	11/01/1999	11/02/1999	1	UNK	PVT	PVT	NONE	Sore throat	Asthma NOS; Lyme's disease		HQ5598315NOV1999	1						1	Injection site erythema; Injection site swelling	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~466441~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0162047	10/06/2000	TX	65.0	65		F	03/23/2000	The pt developed redness, swelling and a 10cm area of induration at the injection site. She also developed a fever and arthralgia. She was treated with corticosteroids, antihistamines and antibiotics. The redness, swelling and induration resolved, but a 1cm area of necrosis had developed. Some drainage from the site was noted.									U	11/12/1999	11/13/1999	1	UNK	PVT	OTH	Synthroid	UNK	UNK		HQ7430106DEC1999	1						1	Abscess; Arthralgia; Injection site erythema; Injection site induration; Injection site necrosis; Injection site oedema; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~458744~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0162050	10/06/2000	CA	73.0	73		F	02/28/2000	Within 24 hours, the pt developed an injection site reaction at the site characterized by swelling and redness. The pt recovered.									Y	11/29/1999	11/30/1999	1	UNK	PVT	OTH	Atenolol, Hydorchorothiazide, Premarin, Thyroxine	NONE	drug hypersensitivity, hypertension, hysterectomy, nephrectomy, salpingo-oopherectiomy		HQ7822308DEC1999	1						1	Injection site erythema; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~459042~1~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0162052	10/06/2000	NY				F	02/04/2000	The evening of the vax, the pt developed pain and swelling at the injection site so severe that she could not lift her arm. The next day she developed nausea and a headache.									U	10/14/1999	10/14/1999	0	UNK	PUB	OTH	UNK	NONE	UNK		HQ8086310DEC1999	1						1	Headache; Hypokinesia; Injection site oedema; Injection site pain; Nausea; Pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~459038~1~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0162053	10/06/2000	VT	56.0	56		M	12/14/1999	On the same day of vax, the pt developed an injection site reaction in the right arm characterized by swelling which extended over the upper arm and pain. The pt also developed ecchymotic areas in the upper arm and forearm. The pt recovered.									Y	10/13/1999	10/13/1999	0	UNK	PVT	OTH	UNK	NONE	UNK		HQ8314513DEC1999	1						1	Injection site haemorrhage; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4998212~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~461144~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0162054	10/06/2000	VT	36.0	36		M	03/15/2000	The same day of vaccination, the pt developed an injection site reaction characterized by upper arm pain and swelling to the Pnu-Imune site. The pt also developed bruising at the injection site. The pt recovered.									U	10/13/1999	10/13/1999	0	UNK	PVT	OTH	NONE	NONE	UNK		HQ8314913DEC1999	1						1	Injection site haemorrhage; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4998212~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~461144~1~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0160405	10/10/2000	NY	65.0	64		F	10/06/2000	Post vax, the pt had erythema in mid right deltoid extending to just below the elbow. Sight fluctuance mid lesion. No fever.									U	10/03/2000	10/03/2000	0		PVT	PVT	Zoloft, Premarin, Chlorthalidone, K-dur, Zestril, calcium					1						1	Injection site erythema	FLU3~MEDEVA PHARMA, LTD.~E59240GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1217J~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0113464	10/12/2000	NY	48.0	48		M	10/06/2000	A few weeks following vax, the pt began experiencing tingling and numbness in his feet. The pt saw his family MD and finally went to a neurologist. Finally the MD attributed the peripheral neuropathy to an auto immune adverse reaction to the flu vaccine. He conducted many test to rule out diabetes and other conditions								Y	U	10/25/1997	10/25/1997	0	blood sugar, electro conduction,	OTH	UNK						1						2	Neuropathy peripheral; Paraesthesia	FLU3~PFIZER\WYETH~4978195~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Disabling	Influenza
0118965	10/13/2000	SC	24.0	24		F	11/12/1999	Allergic reaction, fever, injection site inflammation, lymphadenopathy. A nurse reported that her daughter received vaxs on 10/21/1998. Within 24 hours, she developed an allergic reaction characterized by fever of 104 degrees F, a lump and redness at the Pnu-Imune-23 injection site, swelling in her throat and a swollen axillary lymph node. She was seen by a physician twice and treated with prednisone, Benadryl and applications of ice. The mother attributed this reaction to Pnu-Imune-23. Additional information was received from vax provider on 01/11/99 stating that the pt's temperature reached 101 degrees rather than 104. The pt experienced chills and redness at the Pnu-Imune-23 injection site on 10/22/98. The fever and chills continued on 10/23 and the pt developed a swollen axillary lymph node with redness extending to the neck. Swelling of the throat was not confirmed. She was seen by physician and treated with Benadryl. On 10/28, the pt developed a 3-inch wheal at the Pnu-Imune-23 site with numbness in her fingers. She was again seen by physician and treated with prednisone. She recovered 11/06. This is 1 or 3 reports from this site of adverse events following receipt of this vax, lot 454959, or concomitantly administered vax. Medical affairs note: Pnu-IMUNe-23 is not indicated for individuals less than 65 years of age who are not at an increased risk for the pneumococcal disease. From additional information received on 11/08, corrections to the spelling of the county and the name of the person who administered the vax and completed form were made. No other information is available at this time.				Y						10/21/1998	10/22/1998	1		PVT	PVT		UNK	Fibromyalgia		U1999007440	1						3	Chills; Erythema; Hypersensitivity; Hypoaesthesia; Injection site hypersensitivity; Injection site mass; Lymphadenopathy; Pharyngeal oedema; Pyrexia	FLU3~CONNAUGHT LABORATORIES~967040~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~PFIZER\WYETH~454959~UNK~SC~LA~PNEUMO (PNU-IMUNE)~3	USA	Emergency room visit	Influenza
0126932	10/13/2000	PA	32.0			M	07/28/1999	This 32-year-old male received vax on November 18, 1998. Reportedly the pt was dxed by a neurologist with transverse myelitis. The initial reporter who is also the pt's wife and a registered nurse stated, This has not been reported by physician or neurologist and requested that they not be contacted.				Y					U	11/18/1998				UNK	UNK					U1999005060	1						2	Myelitis	FLU3~CONNAUGHT LABORATORIES~0966960~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0128585	10/13/2000	CA	63.0	63		M	12/30/1999	It was reported that a 63 year old male received Fluzone SV '99-'00 at 11:15 on 9/15/99. At 15:00, on 9/16/99, the pt's left arm became red, itchy and tender. The pt recovered completely. No additional information was provided from correspondence on 12/29/99.									Y	09/15/1999	09/16/1999	1		PVT	PVT					U1999007940	1						2	Injection site erythema; Injection site pain; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0063AA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0128586	10/13/2000	CA	30.0	30		F	12/30/1999	It was reported that a 30 year old female received Fluzone SV '99-'00 in 9/99. She experienced left arm pain, soreness and a small amount of redness. She has recovered completely. No additional information was provided from correspondence on 12/29/99.									Y	09/01/1999	09/01/1999	0		PVT	PVT					U1999007950	1						2	Injection site erythema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~U0063AA~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0128587	10/13/2000	CA	74.0	74		F	12/30/1999	It was reported that a 74 year old female received Fluzone SV '99-'00 at 11:30 on 9/15/99. At 15:00, on 9/15/99, the pt complained that her right arm was red, raised and swollen at the site, 4 X 1 wide. No further information is available at this time. From additional information received on 12/29/99, it was reported that the pt recovered from this experience.									Y	09/15/1999	09/15/1999	0		PVT	PVT					U1999007930	1						2	Injection site erythema; Injection site swelling	FLU3~CONNAUGHT LABORATORIES~U0063AA~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0129364	10/13/2000	DC	51.0	51		F	12/15/1999	It was reported that a 51 year old female received Fluzone WV '99-'00 on 10/6/99 at 14:00. At 19:30, on 10/6/99, the pt experienced redness, swelling and discomfort at the injection site radiating to the elbow and wrist area. the pt was treated with ice, Benadryl and ibuprofen. The pt made a complete recovery. No additions information was provided.									Y	10/06/1999	10/06/1999	0	NONE	OTH	PVT	Clonidine	NONE	Menopause		U1999007780	1						2	Injection site erythema; Injection site pain; Injection site swelling	FLU3~CONNAUGHT LABORATORIES~U0067AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0129468	10/13/2000	KS	39.0	39		F	12/06/1999	It was reported that 10 minutes after receiving injection, employee experienced chest tightness and shortness of breath. Wheezing occurred. Receiving Albuterol Nebulizer treatment without improvement. Sent to ER with increased wheezing and shortness of breath. Given Epinephrine 1:1000 0.3 ml, SQ; Benadryl 50 mg IV, Tagamet 300 mg IV and Micronephrine Nebulizer treatment with slow improvement. Dismissed from ER to go home at 14:30 on 10/14/99. On 10/15/99, the pt presented in MD's office with a 3.5cm X 4cm red, warm area at the injection cite. From additional information received on 11/18/99, it was reported that on 10/15/99, the pt presented in Employee Health Office with the injection site reaction, not in MD's office, as previously reported.				Y					Y	10/14/1999	10/14/1999	0		PUB	PVT	Celebrex, Bumex, Accolate, Proventil, Asthmacort	Asthma	History of asthma		U1999007860	1						2	Chest discomfort; Dyspnoea; Injection site erythema; Injection site warmth; Wheezing	FLU3~CONNAUGHT LABORATORIES~U0104AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0129553	10/13/2000	OH	56.0	56		M	12/13/1999	It was reported that this male pt received vax, and on the same day, he experienced lower lip swelling and tightness around the mouth. The pt was evaluated by a physician on 10/05/1999. The pt has no problems at this time and the swelling and tightening has resolved. The pt required no treatment. Additional information received on 10/07/99 states that follow up revealed no problems.				Y					Y	10/04/1999	10/04/1999	0		OTH	OTH	Zestoretic		Hypertension		U1999007460	1						2	Face oedema	FLU3~CONNAUGHT LABORATORIES~U0118AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0129622	10/13/2000	MN	53.0			F	10/29/1999	It was reported that a 53 year old female received Fluzone SV '99-'00 on 10/15/99. On 10/18/99, the pt experienced a temperature of 100.6F and body aches. She was evaluated by a family physician on 10/19/99. No further information is available at this time.				Y					U	10/15/1999	10/18/1999	3		UNK	UNK					U1999007910	1						2	Pain; Pyrexia; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0128AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~U0128AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Emergency room visit	Influenza
0129622	10/13/2000	MN	53.0	53		F	06/17/2002	It was reported that the pt received the flu vaccination on 10/15/99. On 10/18/99 she had a temperature of 100.6F and complained of body aches. On 10/19/99, she felt worse and went to see her family physician. MD advised her she was having an adverse reaction to her flu shot. He advised her to stay home for 7-10 days. Follow up #1 06/14/02. During internal auditing of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (deleted chills).				Y					U	10/15/1999	10/18/1999	3		OTH	UNK		NONE	Hayfever		U199900817	1						3	Pain; Pyrexia; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0128AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~U0128AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Emergency room visit	Influenza
0129714	10/13/2000	CA	23.0	23		F	11/01/1999	It was reported that a 23 year old female received a Fluzone SV '99-'00 vaccination on 10/8/99. Reportedly, that same day, the pt was coughing, laryngitis and rhinitis. Two days later, the pt developed a low-grade fever. The pt reportedly recovered from this experience.									Y	10/08/1999	10/08/1999	0		PVT	UNK		NONE	NONE		U1999008030	1						2	Cough; Laryngitis; Pyrexia; Rhinitis	FLU3~CONNAUGHT LABORATORIES~U0096EA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0129936	10/13/2000	IL	26.0	26		F	12/14/1999	It was reported that a female received Fluzone SV '99-'00 on 10/15/99. On 10/18/99, the pt experienced redness and a blister on her upper arm. No further information is available at the time. Additional information provided on 11/22/99; it is reported that the employee received the vaccine on a Friday and on Saturday, 10/16/99, she felt a little dizzy and that afternoon noticed her left arm deltoid was very itchy, red, swollen and sin. vesicle at the site. The pt reported this information to the Occupational Health Services on 10/18/99. In the 11/22/99, report complete pt and physician data were given.									Y	10/15/1999	10/18/1999	3		PVT	PVT		NONE	Hypertension		U1999007880	1						2	Blister; Dizziness; Injection site erythema; Injection site swelling; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0128EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0129953	10/13/2000	CA	42.0	42		F	11/11/1999	It was reported that a 42 year old female received Fluzone SV '99-'00 on 9/30/99. On 10/1/99, she experienced a generalized rash, pruritus, mouth ulcers and flu-like symptoms. The pt has recovered.									Y	09/30/1999	10/01/1999	1		PVT	UNK		NONE			U1999009360	1						2	Influenza like illness; Mouth ulceration; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~U0102AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0130170	10/13/2000	OH	21.0	21		F	02/08/2000	It was reported that a 21 year old female received Fluzone SV '99-'00 on 10/26/99. On the same day, the pt experienced a near syncopal episode, lethargy. She was sent to the ER for evaluation. BP 130/78; 150/104. No further information is available at this time. From additional information received on 2/1/00, it was reported that the pt recovered from this experience. Also reported, reviewed, no additional information at this time.				Y					Y	10/29/1999	10/29/1999	0	BP-130/78; 150/104	OTH	PVT	Potassium supplement	NONE	Frequent PVC's		U1999009080	1						2	Hypertension; Lethargy; Stupor	FLU3~CONNAUGHT LABORATORIES~U0136AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0130221	10/13/2000	OH	42.0	42		F	02/08/2000	It was reported that a 42 year old female received Fluzone SV '99-'00 on 10/22/99. The pt stated that on the same day, post vax, her right arm was so sore to the point it felt as if it were paralyzed. She was not evaluated by a physician. The reporter also mentioned that the pt is on chemotherapy. No further information is available at this time. When additional information was provided on 12/23/99, it is stated that the symptoms were gone by the morning. From correspondence received on 2/1/00, it was reported, reviewed, no additional information at this time.									Y	10/22/1999	10/22/1999	0	UNK	OTH	PVT	Chemotherapy	NONE	Lung cancer		U1999009100	1						2	Hypersensitivity; Injection site pain	FLU3~CONNAUGHT LABORATORIES~U0136AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0130240	10/13/2000	CA	65.0	65		F	12/14/1999	It was reported that a 65 year old female received Fluzone SV '99-'00 on 10/19/99. She developed generalized rash the next day, post vax. No further information is available at this time. According to information received on 11/23/99, the pt cleared with a prednisone taper. A skin biopsy was performed and revealed vacuoles interlaced with dermatitis with necrotic keratinocytes, consistent with erythema multiforme. The physician intends to check a patch test to formaldehyde and tumisol in 3 to 4 months.					Y				Y	10/19/1999	10/20/1999	1	Skin biopsy-revealed vacuoles interface dermatitis with necrotic keratinocytes consistent with erythema multiforme.	PVT	UNK	Zestril, calcium, Hydrochlorothiazide, metoprolol, Premarin	NONE	NONE		U1999008960	1						2	Erythema multiforme; Rash; Skin necrosis; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0155AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~U0155AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Hospitalisation	Influenza
0130240	10/13/2000	CA	65.0			F	11/09/1999	It was reported that a 65 year old female received a Fluzone SV '99-'00 vaccination on 10/19/99. On 10/20/99, the pt experienced generalized hives. She was evaluated by an ER physician and treated with Benadryl and Solu-Medrol and given oral Benadryl to take every 4 hours. She was then evaluated by her own physician who gave her a Medrol pack. Compazine for nausea and additional Benadryl.				Y					U	10/19/1999	10/20/1999	1		UNK	UNK					U1999009050	1						3	Erythema multiforme; Rash; Skin necrosis; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0155AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~U0155AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Emergency room visit	Influenza
0130266	10/13/2000	OH	61.0	61		F	02/08/2000	It was reported that a 61 year old female received Fluzone SV '99-'00 on 10/26/99. On the same day, the pt experienced general body aches, sore throat, and red swollen eye. She was not evaluated by a physician. She was given antibiotic eye drops by the clinic. No further information is available at this time. From correspondence received on 2/1/00, it was reported, reviewed, no additional information at this time.									Y	10/26/1999	10/26/1999	0		OTH	PVT	Premarin, Procardia, Indapamide	NONE	UNK		U1999009070	1						2	Eye swelling; Ocular hyperaemia; Pain; Pharyngolaryngeal pain	FLU3~CONNAUGHT LABORATORIES~U0136AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0130267	10/13/2000	OH	53.0	53		F	06/17/2002	It was reported that a 53 year old female received a Fluzone SV '99-'00 vaccination on 10/7/99. Reportedly the next day, the pt developed a local reaction of redness and swelling, lasting 1 week. On 10/12/99, the pt developed burning and tearing of the eyes, lasting 1 week. On 10/25/99, the pt developed chills, congestion and a cough. The pt is being evaluated today, 11/2/99. From additional information received on 11/2/99, it was reported that the pt is recovering. Additional information dated 11/23/99: Pt is still congested but recovering on her own. Did not come in for evaluation. Follow up #1 06/14/02; During internal auditing of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (added rhinitis)									Y	10/07/1999	10/08/1999	1		OTH	PVT		NONE	NKA		U1999008870	1						2	Chills; Cough; Injection site erythema; Injection site swelling; Lacrimal disorder; Rhinitis	FLU3~CONNAUGHT LABORATORIES~U0136AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0130614	10/13/2000	CA	51.0	51		F	12/14/1999	It was reported that a 51 year old female received a Fluzone SV '99-'00 vaccination on 10/31/99. Reportedly on 11/1/99, the pt experienced a large local reaction of redness (15cm X 18cm), induration and pain at the injection site. From additional information received on 11/5/99, it was reported that the pt was given Benadryl for treatment. Two days later, the local reaction was better (8.5cm X 9.5cm). The pt is still recovering.				Y					N	10/31/1999	11/01/1999	1		PVT	PVT		NONE	NONE		U1999008780	1						2	Injection site erythema; Injection site induration; Injection site pain	FLU3~CONNAUGHT LABORATORIES~U0166AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0130657	10/13/2000	OK	9.0	9		M	06/25/2002	It was reported that a 9 year old male received a Fluzone SV '99-'00 vaccination on 11/4/99, at 11:30. At approx. 12:00 that same day, the pt reported not feeling well. Pt was shaking uncontrollably, temperature 97.6F, pulse 96, resp. 18, and BP 80/60. The pt's mom phoned and she came at 12:20 to take pt to the doctor. At 12:20, the pt's pulse was 92. Reportedly, the pt recovered from this experience. No additional information was provided from correspondence on 12/15/99. Follow up #1 06/19/02:During internal auditing of all files, it was deemed necessary to amend the report the report by updating the Adverse Event coding (added Malaise)				Y					Y	11/04/1999	11/04/1999	0		OTH	OTH		NONE			U1999009510	1						2	Malaise; Tremor	FLU3~CONNAUGHT LABORATORIES~U0205AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0130769	10/13/2000	OK	42.0	42		M	12/14/1999	It was reported that a male pt received a Fluzone SV '99-'00 vaccination on 10/25/99. Reportedly, on 10/27/99, the pt developed muscle twitching. Pt plans to see neurologist if persists. The physician reporting is the pt. From correspondence received on 11/22/99, additional pt, physician and vaccine information was provided.									N	10/25/1999	10/27/1999	2		PVT	PVT					U1999008880	1						2	Muscle twitching	FLU3~CONNAUGHT LABORATORIES~U0129AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0130947	10/13/2000	MO	51.0	51		F	12/28/1999	It was reported that a 51 year old female received a Fluzone SV '99-'00 vaccination on 11/3/99. Reportedly a few minutes, post vax, the pt complained of a funny taste in her mouth. A few minutes later, the pt was getting hoarse and stated her throat felt like it was swelling. The pt was given 2 Benadryl 25mg caps and sent to the ER. Reportedly, the pt recovered from this experience. From additional information received on 12/8/99, an amendment in the vaccine administrator's name was made.				Y					Y	11/03/1999	11/03/1999	0		UNK	PUB			Allergic to Iodine		U1999009410	1						2	Dysgeusia; Dysphonia; Pharyngeal oedema	FLU3~CONNAUGHT LABORATORIES~U0132AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0131033	10/13/2000	KS	50.0	50		F	12/20/1999	It was reported that a 50 year old female received a Fluzone SV '99-'00 vaccination on 11/15/99. Reportedly, on 11/16/99, the pt developed a local reaction of redness and erythema with a blister formation of 2cm oblong. From additional information received on 11/18/99, it was reported that the local reaction occurred on the pt's left deltoid with 3cm erythema and induration. From additional information received on 12/20/99, it was reported, Reviewed, no other information at present time.									U	11/15/1999	11/16/1999	1	NONE	OTH	PVT		Sinusitis	NONE		U1999009920	1						2	Blister; Erythema; Injection site erythema	FLU3~CONNAUGHT LABORATORIES~U0165AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0131413	10/13/2000	CA	47.0	47		F	02/08/2000	It was reported that a 47 year old female was vaccinated with Fluzone SV '99-'00 on 10/20/99. Reportedly, a few hours later, the pt had a 45mm area of redness around the left deltoid at the injection site. The site was also warm, red and painful. No additional information was provided from correspondence received on 2/1/00.									Y	10/20/1999	10/20/1999	0	NONE	PVT	PVT		NONE	CAD: Coronary Artery Disease		U1999010220	1						2	Injection site erythema; Injection site pain; Injection site warmth	FLU3~CONNAUGHT LABORATORIES~U0109BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0131863	10/13/2000	AR	88.0	88		F	12/28/1999	It was reported that a female pt received a Fluzone SV '99-'00 and a Pnu-Imune 23 vaccination mixed in one syringe, on 11/4/99. Reportedly, on 11/6/99, the pt developed urticaria, erythema and an induration. Benadryl 25mg per oral every 4 hours was prescribed. Reportedly, the pt recovered from this experience. No additional information was provided from correspondence returned on 12/15/1999.									Y	11/04/1999	11/06/1999	2		OTH	PUB					U1999009800	1						3	Injection site hypersensitivity; Injection site mass; Injection site erythema; Injection site induration; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~2|FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~3	USA		Influenza
0131864	10/13/2000	AR	78.0	78		F	12/08/1999	It was reported that a female pt received a Fluzone SV '99-'00 and a Pnu-Imune 23 vaccination mixed in one syringe, on 11/4/99. Reportedly, on 11/5/99, the pt developed redness at the injection site 8cm to 10cm, fever, urticaria, erythema and an induration. Benadryl 25mg per oral, every 4 hours, was prescribed. The symptoms resolved between 11/6/99 and 11/9/99. No additional information was provided from follow-up correspondence returned on 12/8/99.									Y	11/04/1999	11/05/1999	1		OTH	PUB					U1999009630	1						3	Injection site hypersensitivity; Injection site mass; Pyrexia; Erythema; Injection site erythema; Injection site induration; Pyrexia; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~2|FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~3	USA		Influenza
0131865	10/13/2000	AR	88.0	88		F	12/17/1999	It was reported that a female pt received a Fluzone SV '99-'00 and a Pnu-Imune 23 vaccination mixed in one syringe, on 11/4/99. Reportedly on 11/6/99, the pt developed urticaria, erythema and an induration. Benadryl was given as treatment. Reportedly, the pt recovered from this experience. No addition information was provided from follow-up correspondence returned on 12/8/99.									Y	11/04/1999	11/06/1999	2		OTH	PUB					U1999009820	1						3	Injection site hypersensitivity; Injection site mass; Urticaria; Injection site erythema; Injection site induration; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~2|FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~3	USA		Influenza
0131926	10/13/2000	IL	63.0	63		M	02/02/2000	It was reported that a 63 year old male received a Fluzone SV '99-'00 vaccination on 11/3/99. On 11/6/99, the pt went rifle shooting with strap for rifle secured around left arm. On 11/7/99, in the evening, the pt stated his left upper arm was sore. On 11/8/99, in the evening, the pt developed a slight fever and generalized discomfort. On 11/9/99, the pt stated every bone in his body hurt. On 11/10/99, the pt took Advil and used a heating pad. The pt reportedly, recovered from this experience. From additional information received on 12/6/99, it was reported that the pt returned to work on 11/10/99. From additional correspondence received on 1/28/00, it was reported, Reviewed with no additional information. Employee is at work with no problems.									Y	11/03/1999	11/07/1999	4	NONE	OTH	PVT	Lipitor, acebutolol, ASA, Garlic, Caffine	NONE	Angioplasty 6/98; Glaucoma 6/98		U1999009700	1						2	Injection site pain; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0155AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0131927	10/13/2000	AR	81.0	80		F	12/17/1999	It was reported that a female pt received a Fluzone SV '99-'00 and a Pnu-Imune 23 vaccination mixed in one syringe, on 11/4/99. Reportedly, on 11/6/99, the pt developed urticaria, erythema and an induration. Benadryl 25mg per oral every 4 hours was prescribed. Reportedly, the pt recovered from this experience. No additional information was provided from follow-up correspondence returned on 12/8/99.									Y	11/04/1999	11/06/1999	2		OTH	PUB					U1999009830	1						3	Injection site hypersensitivity; Injection site mass; Injection site erythema; Injection site induration; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~2|FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~3	USA		Influenza
0131976	10/13/2000	AR	93.0	93		F	12/17/1999	It was reported that a female pt received a Fluzone SV '99-'00 and a Pnu-Imune 23 vaccination mixed in one syringe, on 11/4/99. Reportedly, on 11/6/99, the pt developed urticaria, erythema and an induration. Benadryl 25mg per oral every 4 hours was prescribed. Reportedly, the symptoms resolved on 11/7/99. No additional information was provided from follow-up correspondence returned on 12/8/99.									Y	11/04/1999	11/06/1999	2		OTH	PUB					U1999009840	1						3	Injection site hypersensitivity; Injection site mass; Urticaria; Injection site erythema; Injection site induration; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~2|FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~3	USA		Influenza
0131977	10/13/2000	AR	72.0	72		F	12/28/1999	It was reported that a female pt received a Fluzone SV '99-'00 and a Pnu-Imune 23 vaccination mixed in one syringe, on 11/4/99. Reportedly on 11/4/99, the pt developed redness at and around the injection site 6cm-8cm, itching, urticaria, erythema and an induration. Benadryl 25mg per oral every 4 hours was prescribed. The symptoms resolved between 11/6/99 and 11/9/99. No additional information was provided from correspondence returned on 12/15/99.									Y	11/04/1999	11/06/1999	2		OTH	PUB					U1999009790	1						3	Injection site hypersensitivity; Injection site mass; Pruritus; Urticaria; Erythema; Injection site erythema; Injection site induration; Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~2|FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~3	USA		Influenza
0131979	10/13/2000	CA	34.0	34		F	02/08/2000	It was reported that a 34 year old female received a Fluzone SV '99-'00 vaccination on 10/20/99. Reportedly, on 10/21/99, the pt's left deltoid was red, sore and warm at the injection site. The reaction site was approx. 3 by 2 in diameter and was sore for 3 days. The pt reportedly, recovered from this experience. No additional information was provided from correspondence received on 2/1/00.									Y	10/20/1999	10/21/1999	1	NONE	PUB	PVT		NONE	NONE		U1999010190	1						2	Injection site erythema; Injection site pain; Injection site warmth	FLU3~CONNAUGHT LABORATORIES~U0109BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0132003	10/13/2000	CA	43.0	43		M	03/09/2000	It was reported that a 43 year old male received a Fluzone SV '99-'00 vaccination on 10/13/99. Reportedly, approx. 48 hours, post vax, the pt was awakened in the middle of the night due to itching. The pt reports that he had masses of very small, red dots over his buttocks, mid-thigh to mid-abdomen, arms, hands and ankles. He reports a pronounced red rectangular area over the injection site. These symptoms abated approx. 1 week later. The pt recovered fully. No additional information was provided from correspondence returned on 3/7/00.									Y	10/13/1999	10/16/1999	3	NONE	PVT	PVT	Multi-vitamins, low-dose aspirin	NONE	NONE		U1999010170	1						2	Injection site swelling; Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~U0109Ba~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0132008	10/13/2000	CA	44.0	44		F	12/13/1999	It was reported that a 44 year old female was vaccinated with Fluzone UNSP '99-'00 on 10/23/99. Reportedly, on 10/24/99, the pt developed tenderness deep in my arm pit, almost in the chest area of her left side (the injection side). She reported this area as being extremely tender and hurting and aching all of the time. It hurt the pt to raise her arm over her head for 4 days. The pt also reported a tightness in her left lower back like spasms. On 11/2/99, the pt had an appointment to see doctor and on 11/4/99, labs were drawn.				Y					N	10/23/1999	10/24/1999	1	Lab	PVT	PVT	Ortho-Tricycline, Aspirin	NONE	Heart: MVP		U1999010210	1						3	Back pain; Hypertonia; Hypokinesia; Lymphadenopathy; Pain; Back pain; Hypertonia; Hypokinesia; Lymphadenopathy; Pain; Flank pain; Hypokinesia; Muscle spasms; Musculoskeletal discomfort; Pain	FLU3~CONNAUGHT LABORATORIES~02189P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~02189P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~CONNAUGHT LABORATORIES~02189P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Emergency room visit	Influenza
0132065	10/13/2000	IL		51		F	01/26/2000	It was reported that a 51 year old female received the Fluzone SV '99-'00 vaccine on 11/14/99. On 11/15/99, reportedly, the pt awoke with severe dizziness and nausea. The pt was able to go to work. It is stated that the pt has never had dizziness with nausea in the past. She also states that she has a sensation (warm flush) with reaction. The pt recovered in 2 days. From correspondence received on 1/21/00, amendments for the responsible physician and the name and address of the initial reporter were provided.									Y	11/14/1999	11/15/1999	1	NONE	PUB	PVT	Estrace	NONE	History of root canal, 1 month ago		U1999010420	1						2	Dizziness; Flushing; Nausea	FLU3~CONNAUGHT LABORATORIES~U0163AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0132288	10/13/2000	OH	36.0	36		M	02/02/2000	It was reported that a 36 year old male received a Fluzone SV '99-'00 vaccination on 11/17/99. Reportedly on 11/18/99, the pt developed swelling of wrists of both arms, actually 2 from the wrist. The pt was evaluated by the medical service doctor on 11/19/99; there were no physical impairments. From additional information received on 11/23/99, it was learned that the pt recovered. From correspondence received on 1/28/00, it war reported, 1/25/00, reviewed, no additional information at this time.				Y					Y	11/17/1999	11/18/1999	1		PUB	PUB	TB/Apolsol/Barkeson/03119P/ID	NONE	NONE		U1999010110	1						2	Swelling	FLU3~CONNAUGHT LABORATORIES~U0149DA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0132948	10/13/2000	IL	48.0	48		M	01/26/2000	It was reported that a 48 year old male received a Fluzone SV '99-'00 vaccination on 11/4/99. Reportedly, that same day, the pt complained of pain at the site of the injection and inability to lift left arm. The vaccination was administered with biojecter. From additional information received on 1/19/00, it was reported that as of 12/1/99, the pt continued to have soreness in left arm, rendering him to sleep on his right side. Pt was unable to lift arm over head.									U	11/04/1999	11/04/1999	0		OTH	PVT		NONE	NONE		U1999011090	1						2	Hypersensitivity; Hypokinesia; Injection site pain	FLU3~CONNAUGHT LABORATORIES~U0129AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0133764	10/13/2000	TX	60.0	60		M	01/27/2000	It was reported that a 60 year old male received a Fluzone SV '99-'00 vaccination on 11/17/99. Reportedly, on 11/19/99, the pt complained of pain when lifting arms, which has yet to subside. From additional correspondence received on 1/24/00, it was reported that 2 days, post vax, the pt was unable to lift arm to brush teeth. Within 1 week, pt experienced difficulty lifting both arms, which reoccurs every 2 to 3 days. Tylenol or Advil relieves the pain. The pt was referred to a doctor. The pt was seen and he felt the arm difficulties were not due to Fluzone shot. The pt was given cortisone type shot and told to come back in 2 weeks if not better.				Y					U	11/17/1999	11/19/1999	2		PUB	PUB	1 aspirin daily	NONE	NONE		U1999011310	1						2	Hypokinesia; Pain; Hypokinesia; Pain	FLU3~CONNAUGHT LABORATORIES~U0165AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0165AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0133822	10/13/2000	MA	2.0	2	.4	M	11/01/1999	It was reported that a 2 year old male received Fluzone SV '99-'00 on 10/25/99. Approx. 3 hours, post vax, he developed a papular rash head to toe. He had no respiratory distress and was treated symptomatically. No further information is available at this time.									U	10/25/1999	10/25/1999	0		UNK	UNK					U1999008080	1						2	Diarrhoea; Rash maculo-papular; Rash papular	FLU3~CONNAUGHT LABORATORIES~U0107AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0107AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0133866	10/13/2000	CA	43.0	43		F	01/27/2000	On 1/18/00, the pt developed itching and a rash described as a 1-22mm raised papules with red centers on upper back, chest, arms, left thigh and abdomen. Reportedly the pt recovered from this experience.									Y	01/13/2000	01/17/2000	4	NONE	PUB	PVT	Paxid, Vioxx, Ditropan	NONE	allergy to PCN, Sulfa, Fibromyalgia		U2000000440	1						2	Injection site hypersensitivity; Pruritus; Rash maculo-papular; Pruritus; Rash papular	FLU3~CONNAUGHT LABORATORIES~U0166AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~U0166AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0134204	10/13/2000	NJ	8.0	8		M	12/14/1999	It was reported that an 8 year old male was vaccinated with Fluzone DSP on 10/18/99. The child presented at the doctor's office on 10/31/99, with urticaria, angioedema, difficulty breathing, fever, headache, myalgia and stomachache. It is reported that this child had never received the flu vaccine prior to this 10/18/99 dose. The pt has a history of asthma. To date, there has been no reaction to the 2nd dose of vaccine given on 11/16/99.				Y					U	10/18/1999	10/31/1999	13		UNK	UNK			Asthma		U1999010310	1						2	Abdominal pain; Angioneurotic oedema; Dyspnoea; Headache; Myalgia; Pyrexia; Urticaria; Abdominal pain; Angioneurotic oedema; Dyspnoea; Headache; Myalgia; Pyrexia; Urticaria	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~CONNAUGHT LABORATORIES~~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0150198	10/13/2000	NY	59.0	59		M	04/13/2000	Approximately 5 days post vax, the pt noticed his head falls to his left, shoulder droops to the left. The pt states he experienced difficulty walking, turning head to the right and eating. These symptoms are still persisting.									N	11/25/1999	12/03/1999	8		PUB	PUB	Vasotec	hypertension			U2000002600	1						2	Gait disturbance; Muscular weakness; Difficulty in walking; Muscular weakness; Paralysis	FLU3~CONNAUGHT LABORATORIES~~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0150340	10/13/2000	CA	53.0	53		F	12/13/1999	It was reported that a female pt received a Fluzone '99-'00 vaccination on 10/20/99. Reportedly, on 10/21/99, the pt developed pain at the injection site that radiated to the neck and arm. The pt also had a decreased range of motion.									U	10/20/1999	10/21/1999	1		UNK	UNK					U1999010160	1						2	Bone disorder; Injection site pain; Joint range of motion decreased; Neck pain; Pain; Injection site pain; Joint range of motion decreased; Neck pain	FLU3~CONNAUGHT LABORATORIES~U0130AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0158568	10/13/2000	OR	40.0	40		M	12/15/1999	It was reported that a 40 year old male received Fluzone SV '99-'00 and Pneumovax on 10/11/99. The pt experienced a low-grade fever, 12 hours, post vax. He also, experienced a fever of 102, the same night. Two days later, he experienced a low-grade fever again, along with a headache and general malaise. No further information is available at this time. From additional information received on 12/1/99, it was reported that the illness continued for 10 days.				Y					Y	10/11/1999	10/11/1999	0	CBC-results not reported	PVT	PVT		NONE	NONE		U1999007710	1						2	Headache; Malaise; Pyrexia; Headache; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1|FLU3~CONNAUGHT LABORATORIES~U0063AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~459040~UNK~IM~~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0160525	10/13/2000	MD	73.0	73		M	09/06/2000	8 days after a flu-like illness and 2 days, post vax, pt had numbness in his feet, progressing to GBS, arresting at waist and then descending. Still complaint of tingling in one foot. A letter from his neurologist, stated that he never told the pt that the combination of kidney infection and influenza vaccine caused the GBS. In fact, after review of the records, it is not clear to me that the pt had a kidney infection at all (review of the records indicated that he presented with fever, generalized joint aches, headache, drowsiness and chills and no urinary symptoms, but generalized myalgias. He had a normal white count and although he did have some bacteria on urinalysis, he had no WBCs, negative leukocyte esterase activity and negative nitrates). My discussion with the pt was that in all likelihood he had a viral illness on 10/2/99 and that this was more likely the cause of his GBS than his flu vaccine. The onset of the numbness in his feet occurred on 10/10/00, 8 days after the flu-like illness but only 2 days after the flu shot, too short a time to have been related to the flu vaccine itself.			Y	Y	Y	14			Y	10/08/1999	10/10/1999	2	UA-some bacteria; neg leukocyte esterase activity; neg nitrates	PUB	PUB	NONE	kidney infection	NONE		MD00009	1						1	Arthralgia; Bacterial infection; Headache; Hypoaesthesia; Myalgia; Pyrexia; Somnolence; Viral infection; Arthralgia; Bacterial infection; Guillain-Barre syndrome; Headache; Hypoaesthesia; Kidney infection; Myalgia; Pyrexia; Somnolence; Viral infection	FLUX~PFIZER\WYETH~4998271~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4998271~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Life Threatening,Hospitalisation	Influenza
0161806	10/13/2000	MI	38.0	38		F	03/03/2000	The same day as the pt developed warmth at the site of injection described as extremely hot, arthralgia, body aches and an increased heart rate. The pt recovered.									Y	10/26/1999	10/26/1999	0	UNK	PVT	OTH		NONE	UNK		U2000000560	1						2	Arthralgia; Heart rate increased; Injection site reaction; Injection site warmth; Pain; Arthralgia; Heart rate increased; Injection site warmth; Pain	FLU3~CONNAUGHT LABORATORIES~U0063AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466443~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1|FLU3~CONNAUGHT LABORATORIES~U0063AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~466443~UNK~IM~LA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0162164	10/13/2000	AR				U	12/16/1999	It was reported that a pt received Fluzone SV '99-'00 and Pnu-Imune 23 vaccines mixed in 1 syringe, on 11/4/99. Reportedly, on 11/7/99, at 04:00, the pt's temperature was 98.8F, the pt complained of generalized pain. At 12:00 noon, the pt's temperature was 101.6F and took 2 Tylenol. On 11/8/99, at 12:24, the pt's temperature was 99.4F. At 15:30, the pt complained of severe headache and body ache, temperature was 99.3F and was given DCN twice a day per oral. At 16:25, the pt complained of headache being worse and body ache and was given DCN 100, 2 X a day. No additional information was received from follow-up correspondence returned on 12/6/99.  Follow up on 10/28/2002: During internal review of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (added medication error).  Case was upgraded to a 15-Day-Alert Report.  This case is closed.					Y				U	11/04/1999	11/07/1999	3		OTH	PUB					U1999009600	1						1	Headache; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466444~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0162166	10/13/2000	CA	22.0	22		F	09/27/1999	Guillain Barre Syndrome, paralysis. Two days post vax, this pt developed Guillain Barre Syndrome and paralysis one week post vax. From additional information received on 09/23/99, the pt currently suffers from tingling in fingers and toes, weakness to hip flexors, due to nerve damage, and also suffers from night sweat. The pt stated that, she suffered 3 months of paralysis post vax and recovered enough to walk without any help, but was unable to work more than 20 hours per week. Now the pt is to a point whereas she cannot walk at all. Pt stated that she has seen several doctors about her condition, but none could pinpoint or diagnosis her problem. Laboratory and diagnostic tests were done, but nothing significant was found. All values were within nml limits. The pt could not or would not provide physician information for follow-up with doctors whom she had seen. Pt also stated that the physicians that had seen feel as though her condition is related to the vax that she was given but this information could not be verified.				Y					U	10/01/1996			WBC - increased.	OTH	OTH					U1999006840	1						1	Difficulty in walking; Guillain-Barre syndrome; Muscular weakness; Nerve injury; Night sweats; Paraesthesia; Paralysis; White blood cell count increased	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162167	10/13/2000	CA				F	03/20/2000	It was reported that a female pt received vax on 09/16/99. Reportedly sometime post vax, the pt experienced a red bump at the injection site. From correspondence received on 03/20/00, it was reported that the pt recovered from this event.									Y	09/16/1999				OTH	OTH					U1999006870	1						1	Injection site hypersensitivity; Injection site mass	FLU3~CONNAUGHT LABORATORIES~U0063AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162168	10/13/2000	CA				M	09/28/1999	Injection site reaction, pruritus. It was reported that a male pt received vax on 09/16/1999. Reportedly sometime after the vax, the pt experienced a red raised bump at the injection site accompanied by itching and tenderness. From additional information received on 09/20/99, it was reported that the pt recovered from this experience.									Y	09/16/1999				OTH	OTH					U1999006880	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0063AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162169	10/13/2000	CA				F	09/20/1999	Urticaria, rash. It was reported that a female pt received vax on 09/02/99. Reportedly sometime after the vax, the pt experienced hives and rash over entire body.									U	09/02/1999				OTH	OTH					U1999006890	1						1	Rash; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0063AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162170	10/13/2000	CA				F	09/28/1999	Pain, injection site reaction. It was reported that a female pt received vax on 09/09/1999. Reportedly sometime post vax, the pt experienced redness and pain down arm at the injection site. From additional information received on 09/20/99, it was reported that the pt recovered from the experience.									Y	09/09/1999				OTH	OTH					U1999006900	1						1	Injection site hypersensitivity; Injection site pain	FLU3~CONNAUGHT LABORATORIES~U0063AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162171	10/13/2000	PA	76.0	75		F	04/14/2000	Face edema, lymphedema.  It was reported that a female pt received vax in 10/1999. Reportedly 4 days post vax, the pt experienced facial swelling and swollen lymph nodes. The pt was seen by an infectious disease doctor and had a biopsy done on one of the lymph nodes, the report was lymphoma. The pt was seen by an oncologist and went through chemotherapy. From additional information received on 10/04/99, it was reported that the pt recovered from the experience. As of 04/10/00, reported, 'Reviewed, no additional information at this time...' per physician.				Y					Y	10/01/1998			CAT scan - enlarged lymph nodes in abdomen but not below the waist.	PVT	PVT		NONE	Lymphoma		U1999006960	1						1	Face oedema; Lymphadenopathy; Lymphoma	FLU3~CONNAUGHT LABORATORIES~0984580~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162172	10/13/2000	CA	40.0	40		F	11/05/1999	Duplicate report in system is U19990799. It was reported that a 40-year-old female received vax on 09/29/1999. Approximately 10 minutes post vax, the pt experienced an acute anaphylactic reaction. She was treated in the office and went home. Additional information received 10/04/99 includes pt information, timing of events, illness at time of vax and responsible physician information. It was reported that she received vax and within 20 minutes experienced 'throat swelling, swelling lips, horse voice, shaky (shakiness) and shortness of breath.' Pt received 9% NS IV, Benadryl 50mg, oxygen, Epi .4, breathing treatment of Albuterol and Solu-Medrol 125mg. Pt recovered completely.				Y					U	09/28/1999	09/28/1999	0		PVT	PVT		UTI	NONE		U1999007100	1						1	Anaphylactic reaction; Dysphonia; Dyspnoea; Pharyngeal oedema; Swelling face; Tremor	FLU3~CONNAUGHT LABORATORIES~U0130AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162173	10/13/2000	CA	38.0	38		F	11/05/1999	Laryngismus. A duplicate report is in system: U1999-00797. This report is the original. It was reported that a 38-year-old female received vaxs on 09/30/99. Reportedly 2 hours post vax, the pt felt as though her throat was closing. She reported was seen in the office and was treated with steroids. Information received states that 5 hours post vax, this pt experienced a 'hoarse voice, swelling of the throat and coughing. Pt was given Solu-Medrol 125mg and breathing treatment of Albuterol and Atrovent.' She also  experienced chest tightness. The pt recovered completely.				Y					Y	09/30/1999	09/30/1999	0		OTH	OTH			Allergies-Naprosyn		U1999007110	1						1	Chest discomfort; Cough; Dysphonia; Pharyngeal oedema	FLU3~CONNAUGHT LABORATORIES~U0130AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~7360BBA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0162174	10/13/2000	TX	35.0	35		F	10/07/1999	Fever, chills, myalgia. This pt received vax in an unspecified deltoid and within 4 hours post vax, experienced low-grade fever, chills and myalgia. The pt recovered.									Y	10/04/1999	10/04/1999	0	NONE	OTH	OTH		NONE	NONE		U1999007220	1						1	Chills; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0126FA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162175	10/13/2000	TX	38.0	38		F	10/07/1999	Fever, Chills, Myalgia. It was reported that this female pt received vax in an unspecified deltoid and within 4 hours post vax, experienced a low-grade fever, chills and myalgia. She recovered.									Y	09/30/1999	09/30/1999	0		OTH	OTH		NONE	NONE		U1999007250	1						1	Chills; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0126FA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162233	10/13/2000	FL	54.0	54		F	11/12/1999	It was reported that a 54 year old female received Fluzone SV '99-'00 on 9/29/99. Three days later, the pt developed a severe headache. No further information is available at this time. From additional information received on 11/10/99, it was reported that the pt denied consent. Additional pt and responsible physician information was also provided.									U	09/29/1999	10/02/1999	3		OTH	PVT			Denied allergy to chicken products and Thimerosal; denied neurologic dx.		U1999007470	1						1	Headache	FLU3~CONNAUGHT LABORATORIES~U0127AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162234	10/13/2000	KY	26.0			F	10/21/1999	It was reported that a 26 year old female received a Fluzone SV '99-'00 vaccination on 10/4/99. Reportedly, sometime after the vaccination, the pt experienced a local reaction of redness and swelling along with itching at the injection site.									U	10/04/1999				UNK	UNK					U1999007480	1						1	Injection site erythema; Injection site swelling; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0129AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162235	10/13/2000	DC				F	11/12/1999	It was reported that a female received Fluzone WV (U0067AA) on 10/06/99. The same day, she experienced a large local reaction consisting of redness, swelling, inflammation and tingling ins her arm. The pt was evaluated on 10/7/00. No further information at this time. Additional information received on 11/8/99, includes the pt's information, medication, medical history and vaccine administrator's information. It was also reported that the pt has recovered.				Y					Y	10/06/1999	10/06/1999	0		OTH	PVT	Clonidine	NONE	NONE		U1999007540	1						1	Injection site erythema; Injection site inflammation; Injection site swelling; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~U0067AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162236	10/13/2000	CA	70.0			F	05/03/2000	It was reported that a 70 year old female received Fluzone SV '99-'00 vaccination on 10/6/99. On 10/8/99, the pt experienced a local reaction of redness, swelling and soreness. No further information is available at this time. From correspondence received on 5/2/00, it was reported that the pt recovered from this experience. No further information available regarding this pt or this case. This case is closed.									Y	10/06/1999	10/08/1999	2		UNK	UNK					U1999007560	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~CONNAUGHT LABORATORIES~U0102AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162237	10/13/2000	CA	47.0	47		F	11/12/1999	It was reported that a 47 year old female received Fluzone SV '99-'00 vaccination on 10/4/99, at 07:30. Four hours after she began to experience pain at her left deltoid, which radiated over cap of shoulder and down axilla. It felt like a fractured rib with deep breathing and was difficult to breathe for 72 hours. On 10/8/99, the pt was feeling 100 % recovered. No treatment was given. No additional information was provided from follow-up correspondence request.									Y	10/04/1999	10/04/1999	0		PVT	OTH		NONE	Allergic to sulfa		U1999-007580	1						1	Dyspnoea; Hypersensitivity; Injection site pain; Pleuritic pain	FLU3~CONNAUGHT LABORATORIES~U0096EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162238	10/13/2000	NC	54.0	54		F	10/26/1999	It was reported that a 54 year old female pt received a Fluzone UNSP '99-'00 vaccination on 10/15/99. Reportedly, within 2 hours, post vax, the pt experienced headache, achiness, fatigue and nausea. Placed on Phenergan for nausea. Pt was out of work and in bed. One week later, still feeling nausea, lightheaded and loss of appetite. Also experienced flushing across chest and up neck. Pt is on Premarin from hysterectomy but has not had this flushing before. (**A lot number was provided (4928136415) was determined to be an Aventis Pasteur, Inc. Fluzone product code.)									U	10/15/1999	10/15/1999	0		UNK	UNK					U1999007590	1						1	Anorexia; Dizziness; Fatigue; Flushing; Headache; Nausea; Pain	FLU3~CONNAUGHT LABORATORIES~4928136415~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162239	10/13/2000	NY	14.0			F	11/12/1999	It was reported, that a 14 year old female received a Fluzone SV '99-'00 vaccination on 10/20/99. That same day, the pt became red in the face, sweaty and experienced tightness, in her throat and wheezing. From additional information received on 11/5/99, it was reported that the pt complained of chest pain with cough for 5 days. It was also reported that the pt recovered. Other additional information provided includes pt's information, past medical history and information regarding the responsible physician.				Y					Y	10/20/1999	10/20/1999	0		UNK	UNK		NONE	RAD		U1999007610	1						1	Chest pain; Cough; Flushing; Hyperhidrosis; Throat tightness; Wheezing	FLU3~CONNAUGHT LABORATORIES~U0156AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162240	10/13/2000	NH	42.0	42		F	12/17/1999	It was reported, that a female pt received a Fluzone SV '99-'00 vaccination on 10/18/99. Reportedly, on 10/19/99, the pt experienced general body aches and felt hot, no temperature recorded. The pt treated herself with Motrin and Tylenol and was not evaluated by a physician. Reportedly, the pt recovered from this experience. From additional information received on 12/8/99, it was reported, The pt had generalized achiness for 5-6 days, whereby it was difficult to function.									Y	10/18/1999	10/19/1999	1	NONE	PUB	OTH		NONE	Allergies to amoxicillin (rash), dogs and dust		U1999007620	1						1	Feeling hot; Pain	FLU3~CONNAUGHT LABORATORIES~U0190AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162241	10/13/2000	CA				M	12/13/1999	It was reported that after his flu shot on 10/5, he began to experience soreness and pain to left flank and kidney area. No fever, no hematuria, no treatment given. From additional correspondence received on 11/22/99, addition pt information was provided.									Y	10/05/1999	10/05/1999	0		PVT	UNK		NONE			U1999007630	1						1	Flank pain; Renal pain	FLU3~CONNAUGHT LABORATORIES~U0096EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162242	10/13/2000	MA	39.0	39		F	10/26/1999	It was reported that a 39 year old female received Fluzone SV on 10/4/99 and experienced pain at injection site immediately, generalized muscle aches and fever to 101F and fatigue for 24 hours. Pt now had joint pain. No further information at this time.									U	10/04/1999	10/04/1999	0		UNK	UNK					U1999007640	1						1	Arthralgia; Fatigue; Injection site pain; Myalgia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162243	10/13/2000	VA	44.0	44		F	10/12/1999	It was reported that a 44 year old female received Fluzone SV '99-'00 on 10/9/99 and experienced extreme sleepiness, 4 hours, post vax. No further information is available at this time.									U	10/09/1999	10/09/1999	0		UNK	UNK					U1999007660	1						1	Somnolence	FLU3~CONNAUGHT LABORATORIES~U0103AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162244	10/13/2000	IN	53.0	53		M	10/28/1999	It was reported that a 53 year old male received Fluzone SV '99-'00 on 10/12/99. He experienced wheezing, tingling of fingers, sweating and dizziness 25 minutes, post vax. The pt was treated in the ER. No further information is available at this time.				Y					U	10/12/1999	10/12/1999	0		UNK	UNK					U1999007670	1						1	Dizziness; Hyperhidrosis; Paraesthesia; Wheezing	FLU3~CONNAUGHT LABORATORIES~U0126FA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162245	10/13/2000	PA	33.0	33		M	10/28/1999	It was reported that a 33 year old male received Fluzone SV '99-'00 on 10/12/99. Approximately, 15 hours, post vax, he developed fatigue and body aches. No further information is available at this time.									U	10/12/1999				UNK	UNK					U1999007680	1						1	Fatigue; Pain	FLU3~CONNAUGHT LABORATORIES~U0145BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162246	10/13/2000	CA	69.0	69		M	10/28/1999	It was reported that a 69 year old male received Fluzone SV '99-'00 on 10/12/99. The pt experienced local immediate swelling, hardness and redness. No further information is available at this time.									U	10/12/1999	10/12/1999	0		UNK	UNK					U1999007690	1						1	Injection site erythema; Injection site induration; Injection site swelling	FLU3~CONNAUGHT LABORATORIES~U0094AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162248	10/13/2000	AL	62.0	62		M	12/14/1999	It was reported that a 62 year old male received Fluzone SV '99-'00 on 10/13/99. The pt experienced myalgia in his fingers. No further information is available at this time. Information received on 11/22/99, provided pt's information, time of vaccination and pre-existing conditions. The pt reportedly recovered from this experience.									Y	10/13/1999			NONE	MIL	UNK		NONE	Questionable flu-like illness, 1 month prior, treated with Flutharine.		U1999007720	1						1	Myalgia	FLU3~CONNAUGHT LABORATORIES~U0135AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162249	10/13/2000	AL	44.0	44		M	12/14/1999	It was reported that a 44 year old male received a Fluzone SV '99-'00 vaccination on 10/8/99. Reportedly, 12 hours, post vax, the pt developed myalgia. From additional correspondence received on 11/22/99, it was reported that the pt developed myalgia in his fingers of the extremity in which the vaccine was placed. Myalgia resolved in about 24 hours. No treatment was required.									Y	10/08/1999	10/08/1999	0	NONE	MIL	MIL		NONE	NONE		U1999007730	1						1	Myalgia	FLU3~CONNAUGHT LABORATORIES~U0135AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162250	10/13/2000	NJ				M	10/28/1999	It was reported that a male received Fluzone UNSP '99-'00 on 10/13/99. On that same day, the pt experienced fever, loss of appetite, nausea and weakness. No further information is available at this time.									U	10/13/1999	10/13/1999	0		UNK	UNK					U1999007750	1						1	Anorexia; Asthenia; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162251	10/13/2000	IL	41.0	41		F	10/29/1999	It was reported that a 41 year old female received Fluzone SV '99-'00 on 10/12/99. She experienced an elevated heart rate, jitters, nervousness and hives on the throat and neck area. She was seen in the ER. No further information is available at this time.				Y					U	10/12/1999				UNK	UNK					U1999007760	1						1	Feeling jittery; Heart rate increased; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0126FA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162253	10/13/2000	TN				F	12/14/1999	It was reported that a female received Fluzone SV '99-'00 on 10/5/99. On the same day, she experienced a mild local site reaction. The pt has recovered completely. Reviewed, no additional information at this time, 11/17/99.									Y	10/05/1999	10/05/1999	0		PVT	UNK		NONE	NONE		U1999007790	1						1	Injection site reaction	FLU3~CONNAUGHT LABORATORIES~U0095AA~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162254	10/13/2000	TN	24.0	24		F	12/14/1999	It was reported that a 24 year old female received a Fluzone SV '99-'00 vaccination on 10/5/99, at 13:00. The vaccination was given SQ instead of IM. Reportedly at 18:00 that evening, the pt experienced a strong reaction; 3 to 4 local red, raised area to arm, fever, nausea, diarrhea and headache. The pt reportedly is still experiencing these symptoms. Information received on 11/22/99, states that the pt has had a slight red blush at the area of injection. Otherwise, there are no further symptoms. The fever and headache lasted over a week as of 11/17/99.									N	10/05/1999	10/05/1999	0		PVT	PVT		NONE	NONE		U1999007800	1						1	Diarrhoea; Headache; Injection site erythema; Injection site swelling; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0095AA~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162255	10/13/2000	TN				F	12/14/1999	It was reported that a female pt received a Fluzone SV '99-'00 vaccination on 10/5/99. The vaccination was given SQ instead of IM. Reportedly, that same day, the pt experienced a mild to moderate reaction at the injection site. The pt reportedly recovered from this experience. Reviewed, no additional information at this time, 11/17/99.									Y	10/05/1999	10/05/1999	0		PVT	PVT		NONE	NONE		U199907810	1						1	Injection site reaction	FLU3~CONNAUGHT LABORATORIES~U0095AA~1~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162256	10/13/2000	TN				U	12/14/1999	It was reported that a pt received a Fluzone SV '99-'00 vaccination on 10/5/99. The vaccination was given SQ instead of IM. Reportedly, that same day, the pt experienced local (injection site) reaction, nausea and vomiting. The pt reportedly, recovered from this experience. Reviewed, no additional information at this time, 11/17/99.									Y	10/05/1999	10/05/1999	0		PVT	PVT		NONE	NONE		U1999007820	1						1	Injection site reaction; Nausea; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0095AA~1~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162257	10/13/2000	MN	46.0	46		F	12/13/1999	It was reported that four hours, post vax, the employee experienced difficulty in breathing. She went to the ER where she was seen and prescribed treatment with prednisone, Ventolin and an inhaler. She responded in 30 minutes to treatment. Employee experienced about 2 hours of a croupy cough during 1998 following her Influenza vaccine. No medical attention was sought. Pt has completely recovered. Reviewed, no additional information at this time, 11/22/99.  Follow up on 10/28/2002: Upon internal review of all files, it was deemed necessary to amend the report by updating the Adverse Event coding by adding (added croupy cough, deleted allergic reaction).  This case was upgraded to a 15-Day Alert report due to it being medically significant/SAE and unlabled.  The patients previous adverse event experience from 1998 influenza vaccination was added to box 21 of the VAERS form.  This case is closed.				Y					Y	10/12/1999	10/12/1999	0		PVT	OTH	Atenolol		NONE		U1999007830	1						1	Dyspnoea	FLU3~CONNAUGHT LABORATORIES~U0104AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162258	10/13/2000	MA				F	10/29/1999	It was reported that a female pt received a Fluzone SV 99-'00 vaccination on 10/7/99. Reportedly, that same day, the pt experienced soreness of the arm, radiating to neck and also experienced a headache.									U	10/07/1999	10/07/1999	0		UNK	UNK					U1999007850	1						1	Headache; Injection site pain; Neck pain	FLU3~CONNAUGHT LABORATORIES~U0107AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162260	10/13/2000	CA	56.0	56		M	12/14/1999	It was reported that a 56 year old male received Fluzone SV '99-'00 on 10/12/99. Twenty-four hours, post vax, he developed an 8cm reddened area at site and he also experienced tenderness. No further information available at this time. From additional correspondence received on 11/22/99, additional pt and vaccine information was provided.									U	10/12/1999	10/13/1999	1		OTH	UNK		NONE	NONE		U1999007870	1						1	Injection site erythema; Injection site pain	FLU3~CONNAUGHT LABORATORIES~U0094AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162262	10/13/2000	IL	68.0	68		M	06/25/2002	It was reported that a 68 year old male received Fluzone SV '99-'00 on 10/13/99. On the same day, the pt states that he was pale, weak and had hives on the left forearm. The pt was evaluated by his physician and treated with Benadryl. No further information is available at this time. Follow up #1 06/14/02: During internal auditing of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (added pallor and asthenia) (deleted injection site reaction).									U	10/13/1999	10/13/1999	0		UNK	UNK					U1999007900	1						1	Pallor; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0104AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162267	10/13/2000	PA	36.0	36		F	12/07/1999	It was reported that a female received Fluzone SV '99-'00 on 10/12/99. On 10/17/99, she experienced a rash and itching of the head, back and chest. She has not been evaluated by a physician. No further information is available at this time. From additional information received on 10/19/99, the hospital states that the rash was from Tetracycline, not Fluzone. From additional information received on 11/18/99, it was reported, Patient stated reactions due to antibiotic not due to vaccine.									Y	10/12/1999	10/17/1999	5		PUB	UNK	Tetracycline	NONE			U1999008000	1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~U0066FA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162268	10/13/2000	IL	46.0			F	11/01/1999	It was reported that a 46 year old female received Fluzone UNSP '99-'00 on 10/18/99. On the same day, she experienced numbness around mouth and lisp. No further information is available at this time.									U	10/18/1999	10/18/1999	0		UNK	UNK					U1999008010	1						1	Hypoaesthesia oral	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162269	10/13/2000	MD	45.0			F	11/01/1999	It was reported that a 45 year old female received Fluzone WV '99-'00 vaccination on 10/15/99. Reportedly, on 10/16/99, the pt experienced swelling of lips and face and also shortness of breath.									U	10/15/1999	10/16/1999	1		UNK	UNK					U1999008020	1						1	Dyspnoea; Swelling face	FLU3~CONNAUGHT LABORATORIES~U0118AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162271	10/13/2000	UT	47.0	47		F	11/01/1999	It was reported that a 47 year old female received Fluzone SV '99-'00 on 10/20/99. One hour, post vax, she developed generalized urticaria and itching. No further information is available at this time.									U	10/20/1999	10/20/1999	0		UNK	UNK					U1999008050	1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0159AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162273	10/13/2000	WA	56.0	56		F	11/01/1999	It was reported that a 56 year old female received Fluzone SV '99-'00 on 10/27/99. Within 5 minutes, post vax, she developed numbness and tingling of lips and gums. Also, sweaty palms, stated she could taste it, elevated blood pressure and heart rate, vertigo, nausea and temple pressure. Forty minutes later, she walked out of office. No further information is available at this time.									U	10/27/1999	10/27/1999	0		UNK	UNK					U1999008090	1						1	Dysgeusia; Headache; Heart rate increased; Hyperhidrosis; Hypertension; Hypoaesthesia oral; Nausea; Vertigo	FLU3~CONNAUGHT LABORATORIES~U0110AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162274	10/13/2000	CA	32.0			M	12/30/1999	It was reported that a 32 year old male received Fluzone WV '99-'00 on 10/11/99. On the same day, the pt became diaphoretic, cold and clammy. Pt was evaluated in an ER and was given oral Benadryl. Episode resolved. Pt was discharged with a prescription for Benadryl. The reporter stated I am no doing a VAERS report because we operate out of Qatar and this was not a US citizen. No further information is available at this time. From additional information received on 12/30/99, additional pt, vaccine and responsible physician information was provided.				Y					Y	10/11/1999	10/11/1999	0	NONE	OTH	PVT		NONE	NONE		U1999008100	1						1	Cold sweat; Hyperhidrosis	FLU3~CONNAUGHT LABORATORIES~U0118AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162276	10/13/2000	MD	48.0	48		F	12/07/1999	It was reported that a 48 year old female received a Fluzone WV '99-'00 vaccination on 10/15/99 and reportedly, on 10/16/99, the pt's lips became swollen, no other side effect. The pt reportedly, recovered from this experience. From additional information received on 11/18/99, corrections of the last name of the reporter, vaccine administrator and an amendment of the adverse reaction time were made.				Y					Y	10/15/1999	10/16/1999	1		OTH	PVT		NONE	NONE		U1999008180	1						1	Swelling face	FLU3~CONNAUGHT LABORATORIES~U0118AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162277	10/13/2000	MT	46.0	46		F	08/10/2000	It was reported that a 46 year old female pt received a Fluzone WV '99-'00 vaccination on 10/25/99. Approx. 8 hours, post vax, the pt developed a rash on her upper trunk and across back of her neck. From additional information received on 6/7/00, it was reported that the pt developed the rash on 10/29/99. The rash was located between her shoulder blades and on the posterior aspect of her neck. The pt reportedly, recovered from this experience. No additional information was provided from correspondence on 7/25/00. No further information is anticipated, this case is closed.									Y	10/25/1999	10/29/1999	4		PUB	UNK		UNK			U1999008190	1						1	Rash	FLU3~SANOFI PASTEUR~U0166AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162278	10/13/2000	LA	40.0	40		F	12/15/1999	It was reported that a 40 year old female received a Fluzone WV '99-'00 vaccination on 10/27/99. Reportedly, 24 hours, post vax, the pt developed an itchy rash over face, nick, chest and also at the injection site. The pt was seen by a physician.				Y					U	10/27/1999	10/28/1999	1		UNK	UNK					U1999008240	1						1	Injection site rash; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0158AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162279	10/13/2000	TN	40.0	40		F	11/02/1999	It was reported that a female pt received a Fluzone SV '99-'00 vaccination on 10/28/99. Reportedly, within 5 hours, post vax. the pt developed urticaria.									U	10/28/1999	10/28/1999	0		UNK	UNK					U1999008250	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162280	10/13/2000	OR	53.0	53		F	12/19/1999	It was reported that a 53 year old female received IM injection of .50cc left deltoid, Friday 10/22/99. That evening pt complained of severe left-sided pain, back, shoulder, and neck pain with cramping. Pt became bedridden. Spoke with PCP. Treated with Vicodin with Valium. Denies asthma and GI symptoms. Left arm also hot to touch. From additional information received on 12/6/99, it was reported that the pt is still recovering.									Y	10/22/1999	10/22/1999	0		PVT	PVT	Vanceril, Claritin, Estratest, Seravent, Medroxyprogesterone acetate, Macrabid	NONE	Allergic rhinosinusitis with asthma, food allergies		U1999008590	1						1	Feeling hot; Injection site warmth; Muscle spasms; Neck pain; Pain; Sinusitis	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162281	10/13/2000	CA	70.0	70		F	11/08/1999	It was reported that a 70 year old female received Fluzone SV '99-'00 on 10/6/99. On 10/8/99, the pt experienced a rash on her arm. The pt recovered completely.									Y	10/06/1999	10/07/1999	1		PVT	PVT		NONE			U1999008650	1						1	Rash	FLU3~CONNAUGHT LABORATORIES~U0102AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162282	10/13/2000	NC	53.0	53		F	12/15/1999	It was reported that a female pt received a Fluzone SV '99-'00 vaccination on 10/26/99. Reportedly, on 10/27/99, the pt developed facial paralysis and difficulty speaking. The pt was seen by her doctor on 10/28/00 and was told that this is self-limiting. Correspondence received on 12/1/99, provided more complete pt and physician data, and DOB. The symptoms have resolved and the pt returned to work on 11/15/99.				Y					Y	10/25/1999	10/27/1999	2		OTH	PVT		NONE			U1999008720	1						1	Facial palsy; Speech disorder	FLU3~CONNAUGHT LABORATORIES~U0156AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162283	10/13/2000	MA	42.0	42		M	12/16/1999	It was reported that a 42 year old male received a Fluzone SV '99-'00 vaccination on 10/27/99 and reportedly, 45 minutes, post vax, the pt developed generalized hives, no respiratory distress. From additional information received on 12/6/99, it was reported that the pt recovered from this experience.									Y	10/27/1999	10/27/1999	0	NONE	UNK	UNK					U1999008730	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~U0096AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162284	10/13/2000	CO	43.0	43		F	12/13/1999	It was reported that a female pt received a Fluzone SV '99-'00 vaccination on 10/29/99. Approx. 24 hours, post vax, the pt developed a generalized rash on both legs. The pt was reportedly seen by a NP. From additional information received on 12/9/99, it was reported, no follow-up; pt wouldn't return phone call.				Y					U	10/29/1999	10/30/1999	1	NONE	OTH	PVT		UNK	UNK		U1999008760	1						1	Rash	FLU3~CONNAUGHT LABORATORIES~U0148AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162286	10/13/2000	NY	8.0	8		M	11/15/1999	It was reported that an 8 year old male received a Fluzone SV '99-'00 vaccination on 11/5/99. Reportedly, on 11/7/99, the pt developed axillary lymphadenitis. From additional information received on 11/11/99, it was reported that treatment of PO Keflex was given. The pt reportedly recovered from this experience.				Y					Y	11/05/1999	11/07/1999	2	NONE	PVT	PVT		NONE	Asthma		U1999008810	1						1	Lymphadenitis	FLU3~CONNAUGHT LABORATORIES~U0169AB~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162287	10/13/2000	IL	50.0	50		M	12/29/1999	It was reported that a male pt in his 50's received a Fluzone SV '99-'00 vaccination on 11/3/99, at 09:30. Reportedly a few hours, post vax, the pt developed tingling in his left fingers. From additional information received on 12/21/99, it was reported that the pt recovered by the evening of 11/3/99.									Y	11/03/1999	11/03/1999	0	NONE	OTH	PVT		NONE	NONE		U1999008820	1						1	Paraesthesia	FLU3~CONNAUGHT LABORATORIES~U0134AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162288	10/13/2000	CA				F	11/09/1999	It was reported that a female pt in her 50's received a Fluzone UNSP '99-'00 vaccination and possibly a PPD test on 10/25/99. Reportedly, on 10/26/99, the pt developed a local reaction of redness, swelling and pain at the injection site. On 10/27/99, the pt experienced chills but no fever was documented.									U	10/25/1999	10/26/1999	1		UNK	UNK					U1999008830	1						1	Chills; Injection site erythema; Injection site pain; Injection site swelling	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162289	10/13/2000	NY	18.0			F	12/13/1999	It was reported that an 18 year old female received a Fluzone UNSP '99-'00 vaccination on 10/26/99. Reportedly, on 10/31/99, the pt developed a generalized red, raised rash. The pt was treated with oral Benadryl by the NP at student health. Pt was no evaluated by a physician. Additional information dated 11/16/99; Approx. 2-3 days after I reported this reaction, the pt developed additional symptoms which we determined was the cause of the rash, and not the flu vaccine.									U	10/26/1999	10/31/1999	5		UNK	UNK					U1999008840	1						1	Rash erythematous	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162290	10/13/2000	CA				F	06/17/2002	It was reported that a female received Fluzone SV '99-'00 on 10/22/99. The same day, post vax, she experienced throat closing, chest congestion, swollen upper lip and reddened eyes. She was self-dx'd and did not see a physician. The event lasted 24 hours. Follow up 06/14/01: During the internal auditing oa all files, it was deemed necessary to amend by updating the Adverse Evernt coding (added lung disorder).									Y	10/22/1999	10/22/1999	0		UNK	UNK					U1999008860	1						1	Conjunctivitis; Face oedema; Laryngospasm; Lung disorder	FLU3~CONNAUGHT LABORATORIES~U0159AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162293	10/13/2000	OH	40.0	40		M	12/14/1999	It was reported that a 40 year old male received Imovax ID and Fluzone SV '99-'00 at 11:45 on 10/21/99. At 20:00, on the same day, the pt began experiencing the adverse event. He presented to health services on 10/25/99, with an area of 18mm X 20mm induration to approx. 2mm in height. Denies discomfort now but states 2 days, post vax, was tender at site. States also had malaise the last 2 days. Pt has not recovered. Additional information received on 11/22/99, reported that the evening of the day, post vax, the pt experienced soreness and tenderness at the site. The injection site was red with induration measuring 18mm X 20mm. Each day this reaction began to get smaller and less red. By 11/1/99, no induration or soreness was present.									Y	10/21/1999	10/21/1999	0		OTH	OTH	Tylenol, ibuprofen	NONE	Gout		U1999008900	1						1	Injection site erythema; Injection site induration; Injection site pain; Malaise	FLU3~CONNAUGHT LABORATORIES~U0134AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|RAB~PASTEUR MERIEUX INST.~P09892~UNK~SC~RA~RABIES (IMOVAX ID)~1	USA		Influenza
0162294	10/13/2000	NY	22.0	22		F	12/13/1999	It was reported that a female in her twenties, received Fluzone WV '99-'00 on 10/4/99. Within 4 hours, post vax, the pt experienced weakness, headache, fever and general malaise. This is 1 of 3 similar cases by the same reporter:U199900891 through U199900893. No further information is available at this time. When additional information was provided, it was reported that this pt also experienced nausea and diarrhea. The pt also reports swelling 6cm X 6cm X 1cm at the site of the injection. The pt took Tylenol at the onset of the reaction. This pt is 1 of identical twins with nearly identical reactions.									U	10/26/1999	10/26/1999	0		UNK	UNK		Viral gastroenteritis vs egg allergy	Allergic to strawberries		U1999008910	1						1	Asthenia; Diarrhoea; Headache; Hypersensitivity; Injection site swelling; Malaise; Nausea; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0152AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162295	10/13/2000	NY	22.0	22		F	12/14/1999	It was reported that a female in her twenties, received Fluzone WV '99-'00 on 10/4/99. About 4 hours, post vax, the pt experienced weakness, headache, fever and general malaise. This is 1 of 3 similar cases by the same reporter: U199900891 through U19900893. No further information is available at this time. When additional information was provided, it was reported that this pt also experienced nausea, vomiting and diarrhea. The pt took Tylenol. The pt also reported a slight swelling and a lid erythema about 4cm in diameter at the site of the injection. The pt is 1 of identical twins with nearly identical reactions.									Y	10/26/1999	10/26/1999	0	NONE	PVT	UNK		Viral gastroenteritis vs egg allergy	Allergy to strawberries		U1999008920	1						1	Asthenia; Diarrhoea; Headache; Injection site erythema; Injection site swelling; Malaise; Nausea; Pyrexia; Rash vesicular; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0152AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162296	10/13/2000	NY				M	12/14/1999	It was reported that a male in his late twenties received Fluzone WV '99-'00 on 10/26/99. Within 12 hours, post vax, the pt experienced weakness, headache, fever and general malaise. This is one of three similar cases by the same reporter: U199900891 through U199900893. No further information is available at this time. Additional information provided 11/22/99, stated the following; subsequently it was learned that this employee, who called in sick with the symptoms noted above, was not ill.									U	10/26/1999	10/27/1999	1	NONE	PVT	PVT			NONE		U1999008930	1						1	Asthenia; Headache; Malaise; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0152AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162297	10/13/2000	OR	62.0	62		M	11/09/1999	It was reported that a 62 year old male received Fluzone SV '99-'00 on 10/27/99. Approximately 12 hours, post vax, he developed unilateral headache. No further information is available at this time.									U	10/27/1999				UNK	UNK					U1999008940	1						1	Headache	FLU3~CONNAUGHT LABORATORIES~U0166AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162299	10/13/2000	MO	70.0	70		F	11/09/1999	It was reported that a female pt received a Fluzone SV '99-'00 vaccination on 10/30/99. Reportedly, the pt developed a 6cm reddened area at the injection site.									U	10/30/1999				UNK	UNK					U1999008970	1						1	Injection site erythema	FLU3~CONNAUGHT LABORATORIES~U0149CA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162300	10/13/2000	NY	47.0	47		M	12/15/1999	It was reported that a male pt received a Fluzone SV '99-'00 vaccination on 10/22/99. Reportedly, the next day, post vax, the pt developed a red rash over his entire body, along with ecchymosis and nosebleeds. Correspondence received on 12/1/99, states that the pt began taking vitamin K after a few days with a decrease of gum and nose bleeds. The pt refused to see the doctor, but reported the symptoms on 11/8/99. A fine macular rash with large ecchymosis was noted.									U	10/22/1999	10/23/1999	1		PUB	OTH		NONE	NONE		U1999008980	1						1	Ecchymosis; Epistaxis; Rash macular	FLU3~CONNAUGHT LABORATORIES~U0150AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162301	10/13/2000	NC	34.0			F	12/15/1999	It was reported that a 34 year old female received Fluzone SV '99-'00 on 10/13/99. On 10/14/99, she experienced a local reaction of redness, warmth and swelling. No further information is available at this time. Documentation received on 12/1/99 stated: Although redness and tenderness is a normal reaction to vaccination, in this case of this associate, the site was extremely warm to touch and was about 2 X 2 in size.									U	10/13/1999	10/14/1999	1		OTH	PVT	Claritin	NONE			U1999009010	1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~CONNAUGHT LABORATORIES~U0134DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162302	10/13/2000	NC	48.0			F	11/09/1999	It was reported that a 48 year old female received Fluzone SV '99-'00 on 10/14/99. The same day, she experienced a local reaction of redness, warmth and swelling. No further information is available at this time.									U	10/14/1999	10/14/1999	0		UNK	UNK					U1999009020	1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~CONNAUGHT LABORATORIES~U0134DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162303	10/13/2000	PA	41.0	41		F	12/15/1999	It was reported that a 41 year old female received a Fluzone WV '99-'00 vaccination on 11/5/99. Reportedly, that same day, the pt developed hives on trunk and arms; also experienced itching of her face and scalp. The pt was treated with oral Benadryl and was given oral Benadryl to take home. Correspondence received on 12/1/99, provided additional pt demographic data.									U	11/05/1999	11/05/1999	0		UNK	UNK					U1999009030	1						1	Pruritus; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0152AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162305	10/13/2000	CA	46.0	46		M	06/04/2002	It was reported that a male pt received a Fluzone SV '99-'00 vaccination on 11/5/99. Reportedly, sometime post vax, the pt developed a red rash at the injection site. Additional information received 11/22/99, reported that the rash eventually spread from the elbow to the shoulder and that the pt's arm increased in diameter. The rash itched a lot. The symptoms cleared after 12 days. The only treatment was Benadryl OTC. Follow up #1 06/04/02: duriing internal auditing of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (added some edema and pruritis)									Y	11/05/1999	11/07/1999	2		OTH	PVT		NONE	Allergic to bell peppers; history of acne and hayfever.		U1999009060	1						1	Oedema; Rash erythematous; Rash pruritic	FLU3~CONNAUGHT LABORATORIES~U0066DA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162308	10/13/2000	ME	15.0	15		F	12/15/1999	It was reported that a 15 year old female received Fluzone SV '99-'00 on 10/26/99. The pt experienced a rash on her arm down to her elbow that evening. The next day, she developed random swelling of joints, hands and feet, with aching. The event is still present.									N	10/26/1999	10/26/1999	0	NONE	PUB	PVT		NONE	NONE		U1999009090	1						1	Joint swelling; Pain; Rash	FLU3~CONNAUGHT LABORATORIES~U0094AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162310	10/13/2000	WA	53.0	53		F	11/09/1999	It was reported that a 53 year old female received Fluzone SV '99-'00 at 11:00 on 10/25/99. The next morning, the pt experienced a red, swollen area, 3 by 2 on her left upper arm that was hot and tender to touch. No further information is available at this time.									U	10/25/1999	10/26/1999	1		PUB	PUB					U1999009110	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~CONNAUGHT LABORATORIES~U0160AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162311	10/13/2000	FL	74.0			F	11/11/1999	It was reported that a 74 year old female received a Fluzone SV '99-'00 vaccination on 11/3/99. Reportedly, on 11/9/99, the pt experienced diplopia.									U	11/03/1999	11/09/1999	6		UNK	UNK			Hypertension		U1999009340	1						1	Diplopia	FLU3~CONNAUGHT LABORATORIES~U0207AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162312	10/13/2000	GA	44.0	44		M	07/17/2002	It was reported that a 44 year old male received a Fluzone '99-'00 and an unspecified vaccination on 10/29/99. Reportedly, on 10/31/99, the pt developed body aches, injection site pain, muscle spasms, headache, stiff neck and muscle cramps in legs. From additional information received on 12/9/99, it was reported that 24 hours, post vax, the pt developed soreness at the injection site, tingling in left side, numbness, muscle weakness and stiffness, headaches and muscle spasms from neck to toes. The pt saw his primary physician, an orthopedic specialist and allergist. The pt has a referral for neurologist. Follow up #1: During internal auditing of all files, it was deemed necessary to amend the report by updating the adverse event coding (deleted twitching and added myasthenia and paresthenia).									U	10/29/1999	10/30/1999	1		UNK	UNK					U1999009350	1						1	Headache; Hypotonia; Injection site pain; Myasthenic syndrome; Nuchal rigidity; Pain; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162315	10/13/2000	PA				M	11/11/1999	It was reported that a 72 year old male received a Fluzone '99-'00 vaccination on 10/22/1999. Reportedly on 10/30/99, the pt developed a red area on his left arm that looks like a rash. The rash was noted 4 days, post vax of the Hep-B shot.									U	10/22/1999	10/30/1999	8		UNK	UNK					U1999009420	1						1	Injection site erythema; Rash	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162316	10/13/2000	CO				F	11/12/1999	It was reported that a female pt received a Fluzone SV '99-'00 vaccination on 10/22/99. Reportedly, sometime post vax, the pt developed numbness of her left arm. Pt stated the numbness has increased rather than decreased.									U	10/22/1999				UNK	UNK					U1999009460	1						1	Hypoaesthesia	FLU3~CONNAUGHT LABORATORIES~U0110AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162318	10/13/2000	LA	46.0	46		F	12/28/1999	It was reported that a female pt received a Fluzone SV '99-'00 vaccination on 10/8/99. Sometime, post vax, the pt developed upper arm discomfort and shoulder pain in both arms for approx. 5 weeks. A health care provider did not see the pt. From additional information received on 12/14/99, additional pt and responsible physician information was provided.									U	10/08/1999				PUB	UNK					U1999009530	1						1	Injection site pain; Shoulder pain	FLU3~CONNAUGHT LABORATORIES~U0126FA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162319	10/13/2000		61.0			F	11/16/1999	It was reported that a female pt received a Fluzone UNSP vaccination, date not reported. Reportedly, sometime post vax, the pt developed a fever, tightness in chest, chills and general body aches. Pt is also coughing up yellow sputum. A chest X-ray and a throat culture have been done. Doctor's dx is bronchitis. From additional information received on 11/14/99, it was reported, (Pt) called back to inform us that her chest X-ray and throat culture showed pneumonia. Her doctor put her own Levaquin. Doctor still refuses to give her information to file a VAERS report because he told her she did not have a reaction to the vaccine, she has pneumonia.				Y					U				CXR and Throat culture-showed pneumonia	UNK	UNK					U1999009540	1						1	Bronchitis; Chest discomfort; Cough; Pain; Pneumonia; Pyrexia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162320	10/13/2000	OH				F	11/15/1999	It was reported that a female pt received a Fluzone UNSP vaccination on 11/1/99. Reportedly, that same day, the pt experienced a local reaction of stinging when receiving the shot and redness at the site, afterwards. Pt also stated, I felt as if I had some swelling of the tongue but nothing that worried me. It has dissipated.									U	11/01/1999	11/01/1999	0		UNK	UNK					U1999009550	1						1	Injection site erythema; Injection site pain; Tongue oedema	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162321	10/13/2000	FL	46.0	46		F	11/16/1999	It was reported that a 46 year old female received a Fluzone UNSP '99-'00 vaccination on 11/11/99. Reportedly, 6 hours, post vax, the pt developed a rash on her chest. Three days later, the rash began to itch.									U	11/11/1999	11/11/1999	0		UNK	UNK					U1999009590	1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162322	10/13/2000	AR				F	12/16/1999	It was reported that a female pt received a Fluzone SV '99-'00 and a Pnu-Imune 23 vaccination mixed in one syringe, on 11/4/99. Reportedly, on 11/6/99, the pt developed urticaria, erythema and an induration. Benadryl 25mg per oral every four hours was prescribed. The symptoms resolved on 11/9/99. No additional information was provided from follow-up correspondence returned on 12/6/99.									Y	11/04/1999	11/06/1999	2		OTH	PUB	Prenatal vitamins, Resperidone Penactin				U1999009610	1						1	Injection site erythema; Injection site induration; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466440~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0162323	10/13/2000	AR				F	12/16/1999	It was reported that a female pt received a Fluzone SV '99-'00 and a Pnu-Imune 23 vaccination mixed in one syringe, on 11/4/99. Reportedly, on 11/6/99, the pt developed urticaria, erythema and an induration. Benadryl 25mg per oral, every 4 hours, was prescribed. The symptoms resolved on 11/9/99. No additional information was provided from follow-up correspondence returned on 12/6/99.									Y	11/04/1999	11/06/1999	2		UNK	UNK					U1999009620	1						1	Injection site erythema; Injection site induration; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0162325	10/13/2000	TX	21.0			F	01/05/2000	It was reported that a 21 year old female received a Fluzone SV '99-'00 vaccination on 11/15/99. Reportedly, on 11/16/99, the pt experienced pain at the injection site with radiation down her arm, described as mild pain. Also experienced numbness, which was described as mostly tingling in her fingers. Pt stated it was an odd sensation, however, she is able to use her extremity without any impairment. The pt decided not to be evaluated by a physician at this time and is at work functioning in a normal capacity. From additional information received on 1/5/00, it was reported that the pt recovered from this experience.									Y	11/15/1999	11/16/1999	1		OTH	PVT					U1999009690	1						1	Hypoaesthesia; Injection site pain	FLU3~CONNAUGHT LABORATORIES~U0160AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162327	10/13/2000	WA	22.0			F	06/24/2002	It was reported that a traveling health nurse who was providing TB screening to employees at a daycare center, stated that after several complaints of severe burning upon administration, she discovered that she was in fact, injecting influenza (Fluzone SV '99-'00). A 22 year old female pt stated that her arm is very red and swollen. The area is approx. 2 long and feels squishy also her forearm has patchy numbness. The pt complains of a severe headache, like a sinus infection. The pt is hesitant to be evaluated by a physician. Follow up #1 06/19/02:  During an internal auditing of all files, it is deemed necessary to amend the report by updating the Adverse Event coding (Added  Medication Error and re-ranked events)									N					UNK	UNK			Patient denies any history of allergies. She has not been sick. She has not been exposed to the influenza vaccination prior to event.		U1999009710	1						1	Headache; Hypoaesthesia; Injection site erythema; Injection site swelling	FLU3~CONNAUGHT LABORATORIES~U0130AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162328	10/13/2000	WA	31.0			F	06/04/2002	It was reported that a traveling health nurse who was providing TB screening to employees at a daycare center stated that after several complaints of severe burning upon administration, she discovered that she was in fact, injecting influenza (Fluzone SV '99-'00). A 31 year old female pt stated that administration of vaccination was very painful and burned a lot. The pt experienced immediate swelling and redness. Approx. 2 hours, post vax, she experienced tachycardia, difficulty breathing, nausea and vomiting, headache and lightheadedness. Within 15 minutes of onset, she experienced hives all over her arm. The nurse responsible for vaccination went to the pt's home and told the pt to take Benadryl 2 tablets every 4-6 hours. At the time of this report, the pt was experiencing flu-like symptoms and had a very bad headache. Upon interview, it was discovered that this pt has severe allergic response to all food coloring, additives and preservatives and is allergic to all 'chillin's. She describes her previous reactions as severe hives, skin sloughing, nausea and vomiting and headache. Writer expressed the need for this pt to be evaluated by her physician ASAP. Follow up #1 06/05/02: During internal auditing of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (Added Dyspnea, Tachycardia, Medication Error, Vomiting  and Nausea). Also re-ranked all coded terms.									N					UNK	UNK			Pt has severe allergic response to all food coloring, additives and preservatives is allergic to all 'chillin's. She describes her previous reactions as severe hives, skin sloughing, nausea and vomiting and headache. Pt has not been exposed to the influenza vaccination prior to event.		U1999009720	1						1	Dyspnoea; Headache; Influenza; Medication error; Nausea; Tachycardia; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0130AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162329	10/13/2000	WA	39.0			F	06/04/2002	It was reported that a traveling health nurse who was providing TB screening to employees at a daycare center, stated that after several complaints of severe burning upon administration, she discovered that she was in fact, injecting influenza (Fluzone SV '99-'00). A 39 year old female states that she experienced arm swelling and pain immediately, post vax, which she treated with hot/cold compresses. She awoke at 03:00 with nausea and vomiting, headache and flu-like symptoms. She does state that she is recovering from bronchitis/flu and is being treated with Zylex. Pt has received influenza vaccination in the past and has experienced similar symptoms. She has a positive history of Asthma (treated with albuterol PRN). She also states that she had HTN but it is medicated. Follow up #1  06/04/02: during internal auditng of all fines, it was deemed necessary to amend the report by updating the Adverse Event coding. (Added medication error, nausea and vomiting.									N					UNK	UNK	Zylex, Albuterol	Bronchitis/flu being treated	Pt has received influenza vaccination in the past and has experienced similar symptoms. She has a positive history of asthma. She also states that she had HTN but is not medicated.		U1999009730	1						1	Bronchitis; Influenza; Injection site pain; Medication error; Nausea; Oedema peripheral; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0130AA~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162330	10/13/2000	WA	51.0			F	06/24/2002	It was reported that a traveling health nurse who was providing TB screening to employees at a daycare center, stated that after several complaints of severe burning upon administration, she discovered that she was in fact, injecting influenza (Fluzone SV '99-'00). A 51 year old female states that she experienced redness and swelling which developed into painful itching and burning at the site of the injection (approx. 2 1/2 in diameter). At time of report, pt was experiencing nausea and vomiting, headache and was unable to lift with arm. Pt has received influenza vaccine before without incident. She has not been ill. She has a positive history of allergies to ivory dish soap, Codeine and Morphine. follow up #1 06/24/02: during internal auditing of all files, it was deemed necessaryto amend the report by updating the Adverse Event coding (Added Medication Error and Myasthenia; also re-ranked Adverse Events).									N					UNK	UNK			Patient has received influenza vaccine before without incident. patient has not been ill. Patient has a positive history of allergies to Ivory dish soap, Codeine and Morphine.		U1999009740	1						1	Headache; Injection site pain; Injection site reaction; Medication error; Myasthenic syndrome; Nausea; Pruritus; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0130AA~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162331	10/13/2000	WA	49.0			F	06/24/2002	It was reported that a traveling health nurse who was providing TB screening to employees at a daycare center stated that after several complaints of severe burning upon administration, she discovered that she was in fact, injecting influenza (Fluzone SV '99-'00). A 49 year old female states that she experienced redness and swelling which developed into painful itching and burning at site of injection (approx. 1 1/2 in diameter). At the time of report, she states that her whole arm hurts. She has not been exposed to the influenza vaccination. She is presently recovering from bronchitis (amoxicillin was discontinued last week).  She has a positive history of migraine and is allergic to bee stings (carries an epi-pen). Follow up #1 06/19/02: During internal auditing oif all files, it was deemed necessary to amend the report by updating the Adverse Event coding ( Added Medication Error and re-ranked Adverse Events).									N					UNK	UNK		Bronchitis	Patient has not been exposed to the influenza vaccination. She is presently recovering from bronchitis (amoxicillin was discontinued last week. She has a positive history of migraines and is allergic to bee stings (carries an epi-pen).		U199900975	1						1	Injection site pain; Injection site reaction; Medication error; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0130AA~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162332	10/13/2000	WA	44.0			F	06/21/2002	It was reported that a traveling health nurse who was providing TB screening to employees at a daycare center stated that after several complaints of severe burning upon administration, she discovered that she was in fact, injecting influenza (Fluzone SV '99-'00). A 44 year old female states that she is sore and tender at site of injection. There is approx. 1 1/2 to 2 1/2 in diameter that is slightly raised and hard/knot and hot to the touch. She denies nausea and vomiting but does have a mild headache. She has received influenza vaccination before without incident. she is suffering from a slight sinus infection and denies any history of alleries. Follow up #1 06/19/02: During internal auditng of all flies, it was deemed necessary to amend the report by updating the Adverse Event coding  (Added Medication Error and re-ranked Adverse Events).									N					UNK	UNK		Slight sinus infection	Patient has received influenza vaccination before without incident. She is suffering a slight sinus infection and denies any history of allergies.		U199900976	1						1	Headache; Injection site pain; Injection site reaction; Medication error	FLU3~CONNAUGHT LABORATORIES~U0130AA~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162333	10/13/2000	WA	29.0			M	06/21/2002	It was reported that a traveling health nurse who was providing TB screening to employees at a daycare center stated that after several complaints of severe burning upon administration, she discovered that she was in fact, injecting influenza (Fluzone SV '99-'00). A 29 year old male states that the site of injection is sore and red. He denies any other discomfort. He has not been exposed to the influenza vaccination. States he has a positive history of allergy to Pencillin. Follow up #1 06/18/02: During internal auditng of all files,it was deemed necessary to amend the report by updating the Adverse Eventscoding (Added Medication Error, re-ranked Adverse Events).									N					UNK	UNK			Pt has not been exposed to the influenza vaccination. Pt states he has a positive history of allergy to Penicillin.		U199900977	1						1	Injection site pain; Injection site reaction; Medication error	FLU3~CONNAUGHT LABORATORIES~U0130AA~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162336	10/13/2000	AR				F	12/28/1999	It was reported that a female pt received a Fluzone SV '99-'00 and a Pnu-Imune 23 vaccination mixed in one syringe, on 11/4/99. Reportedly, on 11/6/99, the pt developed urticaria, erythema and an induration. Benadryl 25mg per oral every 4 hours was prescribed. Reportedly, the pt recovered from this experience. No additional information was provided from correspondence returned on 12/15/99.									Y	11/04/1999	11/06/1999	2		OTH	PUB	Provera, Premarin, Procardia, ASA, Atenolol, Mil Sinemal, Os cal, Perma				U1999009810	1						1	Injection site erythema; Injection site induration; Urticaria	FLU3~CONNAUGHT LABORATORIES~U0165AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466440~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0162340	10/13/2000	NE	60.0			F	11/23/1999	It was reported that a 60 year old female received a Fluzone SV '99-'00 vaccination on 11/9/99. Approx. 6 hours, post vax, the pt developed enlarged lymph nodes in the right arm and right-side breast tenderness. There symptoms reportedly subsided 1 1/2 days later.									Y	11/09/1999	11/09/1999	0		UNK	UNK					U1999009860	1						1	Breast pain; Lymphadenopathy	FLU3~CONNAUGHT LABORATORIES~U0186AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162341	10/13/2000	OH	64.0	64		F	12/13/1999	It was reported that a 64 year old female received a Fluzone SV '99-'00 vaccination on 11/6/99. Reportedly, on 11/8/99, the pt developed hives. Pt was treated with Tagamet-Kenalog-Medrol pack. From additional information received on 12/9/99, the pt received the Tagamet-Kenalog-Medrol pack on 11/10/99.									U	11/06/1999	11/08/1999	2	NONE	PVT	PVT		NONE	Allergies to trees, dust mites		U1999009890	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~U0102AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162342	10/13/2000	PA	2.0	2	.0	M	12/28/1999	It was reported that a 2 year old male received a Fluzone SV '99-'00 vaccination on 11/16/99. Approx. 4-6 hours later, the pt developed a fever of 105F and an asthma attack that required emergency treatment. From additional information received on 12/15/99, it was reported that the pt was treated with nebulizer at home and that the pt recovered.				Y					Y	11/16/1999	11/16/1999	0		PVT	PVT	Albuterol, Intal		Asthma		U1999009910	1						1	Asthma; Pyrexia	FLU3~CONNAUGHT LABORATORIES~U0157AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162344	10/13/2000	NJ	50.0			F	12/28/1999	It was reported that a 50 year old female received a Fluzone SV '99-'00 vaccination on 11/3/99. Reportedly, on 11/8/99, the pt developed Bell's Palsy on left side of face. From additional information received on 12/8/99, additional pt, vaccine and responsible physician information was provided.									U	11/03/1999	11/08/1999	5		UNK	UNK					U1999009930	1						1	Facial palsy	FLU3~CONNAUGHT LABORATORIES~U0128DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162345	10/13/2000	FL	37.0			F	12/30/1999	It was reported that a 37 year old female received a Fluzone SV '99-'00 vaccination on 10/22/99. Reportedly, on 10/26/99, the pt developed benign paroxymal positional vertigo. From additional information received on 12/20/99, additional pt and responsible physician information was provided.									U	10/22/1999	10/26/1999	4		PVT	UNK					U1999009940	1						1	Vertigo	FLU3~CONNAUGHT LABORATORIES~U0158AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162347	10/13/2000	VA				F	06/04/2002	It was reported that a female pt received a Fluzone SV '99-'00 vaccination in her right forearm. Within 1 minute of vaccination, the pt developed itching and an elevated, red wheal the size of a dime. As well as local itching, flushed face and blood pressure increased to 156/84. The pt was given Allegra and Axid and was told if she had any difficulty breathing to go to the ER. Follow Up #1 06/04/02: During internal auditing  of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (Added Vasodilatation and Hypertension).				Y					U					UNK	UNK			Allergies to hay fever, cats, ragweed and raw eggs. History of allergic rhinitis.		U199901014	1						1	Hypersensitivity; Hypertension; Vasodilatation	FLU3~CONNAUGHT LABORATORIES~UO156AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162348	10/13/2000	VT	56.0			M	12/29/1999	It was reported that a 56 year old male pt received a Fluzone UNSP '99-'00 vaccination on 10/14/99. Reportedly, on 10/31/99, the pt developed paresthesia from sole of left foot with gradual increase to left leg, left side of body and left arm to the forearm. The paresthesia has faded in the same pattern it progressed. No right side involvement, pt's reflexes were normal. Pt also developed paresthesia below right ankle at this time and is fading. The doctor has not confirmed dx with spinal tap or nerve conduction studies due to symptoms resolving at this time. No additional information was provided from correspondence returned on 12/17/99.				Y					Y	10/14/1999	10/31/1999	17	MRI scan of right brain-nml	UNK	UNK					U1999010150	1						1	Paraesthesia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162353	10/13/2000	GA	28.0			F	12/13/1999	It was reported that a 28 year old female pt received a Fluzone SV '99-'00 vaccination on 11/24/99. Reportedly, on 12/8/99, the pt developed blurred distant vision. An optometrist examined the pt and there was a slight symmetrical difference in vision per exam. The optometrist recommended evaluation for medical problems.				Y					U	11/24/1999	12/08/1999	14		UNK	UNK					U1999010240	1						1	Vision blurred	FLU3~CONNAUGHT LABORATORIES~U0109BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162354	10/13/2000	NY	44.0	44		F	01/26/2000	It was reported that a 44 year old female pt received a Fluzone SV '99-'00 vaccination on 10/15/99. Reportedly, that same day, the pt developed unexplained paralysis. The pt has a history of fibromyalgia and has been evaluated by her physician. From additional information received on 1/19/00, it was reported, The pt was not specifically seen for 'paralysis'.				Y					U	10/15/1999	10/15/1999	0	NONE	PVT	PVT	Yes specifics not provided		History of fibromyalgia		U1999010250	1						1	Paralysis	FLU3~CONNAUGHT LABORATORIES~U0136AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162356	10/13/2000	FL	54.0	54		M	02/09/2000	It was reported that a male pt received a Fluzone SV '99-'00 vaccination on 11/11/99. On 11/15/99, the pt reports deafness in his left ear. Also, on 11/18/99, the pt reports hearing echoes and at this time is started on steroids. From correspondence received on 2/8/00, it was reported that the pt has partial recovery. Additional pt, vaccine and responsible physician information was also provided.				Y					U	11/11/1999	11/15/1999	4	An audiogram was performed on 11/18/99 and showed a 40 decibel loss (40%) in left ear. Repeat audiogram 20 DB loss.	PVT	PVT		NONE	NONE		U1999010340	1						1	Deafness; Hypoacusis	FLU3~CONNAUGHT LABORATORIES~U0144AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162358	10/13/2000	CA	22.0	22		F	02/08/2000	It was reported that a 22 year old female received the Fluzone SB '99-'00 vaccine on 11/24/99. Reportedly, 6 hours, post vax, the pt started vomiting and vomited at least 6 times between 20:00 on 11/24/99 and 07:00 on 11/25/99. On the morning of 11/25/99, both sides of the pt's jaw started to ache, especially when opening her mouth or chewing. The pain was still present on 11/29/99. From correspondence received on 2/3/00, additional vaccine information was provided.									U	11/24/1999	11/24/1999	0		OTH	PVT		NONE	NONE		U1999010430	1						1	Pain in jaw; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0134DA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162359	10/13/2000	NE	2.9	2	.9	F	12/15/1999	It was reported that a 2 year old female was vaccinated with Fluzone SV '99-'00 on 11/30/99. On 12/1/99, the pt's mother complained pt developed a fever of 101.3F. On 12/2/99, additional complaints consisted of erythema, macular rash, swelling, warmth and pain at the injection site on the left thigh. The pt also reported pain in her knee.									U	11/30/1999	12/01/1999	1		UNK	UNK					U1999010450	1						1	Arthralgia; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pyrexia; Rash macular	FLU3~CONNAUGHT LABORATORIES~U0104AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162360	10/13/2000	AZ	72.0			F	12/15/1999	It was reported that a 72 year old female received the Fluzone WV '99-'00 vaccination. Reportedly, several hours, post vax, the pt developed a rash over her entire body and extremities. She also had itching.									U	12/01/1999	12/01/1999	0		UNK	UNK					U1999010460	1						1	Pruritus; Rash	FLU3~CONNAUGHT LABORATORIES~U0170AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162361	10/13/2000	NJ				M	12/17/1999	It was reported that a male pt received a Fluzone UNSP '99-'00 vaccination on 10/25/99. Reportedly, sometime post vax, the pt experienced intestinal problems consisting of diarrhea and cramps. The pt was evaluated by a physician and underwent a barium colon enema on 12/8/99.				Y					U	10/25/1999			12/8/99-Barium colon enema	UNK	UNK					U1999010690	1						1	Abdominal pain; Diarrhoea	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162363	10/13/2000	CA				M	12/29/1999	It was reported that a male pt received a Fluzone UNSP '99-'00 vaccination. Reportedly, within 24 hours, the pt developed a local reaction of redness and tenderness at the injection site. The pt also developed generalized malaise and arthralgia.									U					UNK	UNK					U1999011120	1						1	Arthralgia; Injection site erythema; Injection site pain; Malaise	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162364	10/13/2000	WA	42.0	42		M	12/29/1999	It was reported that a male pt received a Fluzone SV '99-'00 vaccination on 10/7/99. Reportedly, sometime post vax, the pt developed tingling in both feet with intense sensation of pinpricks on bottoms. The pt was seen by his primary physician who referred him to a Neurologist.				Y					U	10/07/1999			MRI-results are pending	UNK	UNK					U1999011140	1						1	Paraesthesia	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162365	10/13/2000	MO	57.0	57		F	12/29/1999	It was reported that a female pt received a Fluzone SV '99-'00 vaccination on 10/26/99. Reportedly on 10/29/99, the pt complained of left arm being sore and bruised. On 11/1/99, the pt complained of left side swelling of back. During the week of 12/8/99, the pt went to the Chiropractor and was treated with heat and electrical stimulation, which helped relax her back. On 11/27/99, the pt went to the ER and was referred to a vascular surgeon. On 12/6/99, the pt went to a vascular surgeon, who referred the pt to an Orthopedic Surgeon. The pt saw a MA on 12/27/99.				Y					U	10/29/1999	10/29/1999	0		UNK	UNK					U1999011240	1						1	Back pain; Injection site haemorrhage; Injection site pain; Swelling	FLU3~CONNAUGHT LABORATORIES~U0127AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162366	10/13/2000	MI	30.0	30		F	12/29/1999	It was reported that a female pt received a Fluzone SV '99-'00 vaccination on 12/2/99. Reportedly, several days, post vax, the pt developed a rash on her arms and face which lasted approx. 3 weeks.									U	12/02/1999				UNK	UNK					U1999011270	1						1	Rash	FLU3~CONNAUGHT LABORATORIES~U0163AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162367	10/13/2000	OR	43.0	43		F	01/14/2000	It was reported that a 43 year old female received a Fluzone SV '99-'00 vaccination on 12/6/99. Reportedly, 2 days, post vax, the pt developed a purple rash on her legs from her ankles to her thighs. From additional information received on 1/13/00, it was reported that the pt recovered from this experience. Additional pt, vaccine and responsible physician information was also provided.									Y	12/06/1999	12/08/1999	2		PUB	PVT					U1999011280	1						1	Rash; Skin discolouration	FLU3~CONNAUGHT LABORATORIES~U0130AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162369	10/13/2000	OH	18.0	18		M	01/24/2000	It was reported that an 18 year old male received a Fluzone SV '99-'00 vaccination as well as a PPD-Tubersol skin test on 12/29/99. Approx. 5 hours, post vax, the pt developed dizziness. In the morning of 12/30/99, the pt developed heaviness in chest and a hoarse voice. Pt denies any difficulty breathing. From correspondence received on 1/17/00, additional pt and responsible physician information was provided.									U	12/29/1999	12/29/1999	0		PUB	PUB	PPD/Tubersol 5 TU/Aventis Pasteur Ltd/250211				U1999011360	1						1	Chest pain; Dizziness; Dysphonia	FLU3~CONNAUGHT LABORATORIES~U0160AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162370	10/13/2000	OR	42.0	42		F	02/02/2000	It was reported that a 42 year old female pt received Fluzone SV '99-'00 vaccination on 11/30/99. Reportedly, the pt experienced immediate pain at the injection site. The pt has experienced pain shooting down arm occasionally since the vaccination was given. The pt was seen by her physician on 12/7/99 and was dx'd with rotator cuff tendonitis. From correspondence received on 1/28/00, additional pt, responsible physician and vaccine information was provided.				Y					U	11/30/1999	11/30/1999	0		OTH	UNK		UNK	UNK		U2000000030	1						1	Injection site pain; Rotator cuff syndrome; Tendonitis	FLU3~CONNAUGHT LABORATORIES~U0167AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162526	10/13/2000	NV				F	06/17/2002	This pt received vax on 11/10/99 and reported that post vax, she experienced a 'toxic reaction.' She experienced pain on one side of her head and her 'eye blew out.' Numerous doctors have seen the patient and the pain medication her internist had given her is not effective. The pt was seen by a neurologist who had a MRI scan of her head and the orbit of her eye. No problems were found. The internist suggested that she see an anesthesiologist for the pain. Follow up #1 06/14/02: During internal auditing of all files,it was deemed necessary to amend the report by updating the Adverse Event coding (Added eye disorder).				Y					U	11/10/1999			MRI - head and eye orbit - no problems indicated.	UNK	UNK					U200000007	1						1	Eye disorder; Overdose; Pain	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162527	10/13/2000	MA	7.0	7		M	06/17/2002	It was reported that this child received vax and 8 days post vax, experienced tiredness, lethargy, headache, pallor, puffy eyes, and swollen glands and developed a temperature of 99.1 to 99.9 degrees F. From additional information received on 02/03/00, the pt was seen at physician's office and dxed with ROM (right otitis media) on 12/21/99. Follow up #1 06/14/02: During internal auditing of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (Added headache)				Y					U	12/01/1999	12/09/1999	8		PVT	UNK					U200000011	1						1	Asthenia; Face oedema; Headache; Lymphoedema; Pallor; Pyrexia; Somnolence	FLU3~CONNAUGHT LABORATORIES~UO157AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162528	10/13/2000	FL	20.0	20		F	02/08/2000	Following vaccination the pt stood up and started walking away but was asked to walk back to sign some papers. Once the pt sat down she became unresponsive and presented with pursed lip breathing. The pt laid flat with her feet elevated. The pt became responsive with smelling salts, and was taken to student health for evaluation. The pt reportedly recovered form this experience. It was also reported that the pt also experienced incontinent of urine with this episode.									Y	11/16/1999	11/16/1999	0	BP - 100/60	UNK	UNK		NONE	hx of fainting		U200000180	1						1	Coma; Dyspnoea; Hypotension; Urinary incontinence	FLU3~CONNAUGHT LABORATORIES~U0149AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162529	10/13/2000	TX	35.0			F	01/20/2000	The pt experienced swelling of her face and hands as well as itching of her eyes. The pt took over the counter Benadryl. No further information is available at this time.				Y					U	01/08/2000	01/09/2000	1		UNK	UNK					U200000250	1						1	Eye irritation; Face oedema; Oedema peripheral	FLU3~CONNAUGHT LABORATORIES~U0170AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162532	10/13/2000	AZ				U	02/07/2000	A resident of a nursing home inadvertently received Pnu-Imune and Fluzone mixed in the same syringe. Within 24-36 hours, the pt developed an injection site reaction characterized by redness and inflammation. The resident was treated with an unspecified medication.									U	11/01/1999	11/02/1999	1	UNK	OTH	OTH		UNK	UNK		U2000000570	1						1	Injection site erythema; Injection site inflammation	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0162533	10/13/2000	NY				M	02/29/2000	Following the vaccination, the pt developed severe pain in his shoulder and neck which lasted 2-3 days.									U					UNK	UNK					U2000001070	1						1	Arthralgia; Neck pain	FLU3~CONNAUGHT LABORATORIES~U0132AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162534	10/13/2000	PA				M	03/03/2000	The same day as the vax, the pt developed a local reaction with skin involvement that lasted a week.									U	11/02/1999	11/02/1999	0		UNK	UNK					U2000001190	1						1	Injection site hypersensitivity	FLU3~CONNAUGHT LABORATORIES~U0111AB~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162535	10/13/2000	NY	53.0	53		F	03/20/2000	Approximately 4 days post vax, the pt experienced persistent general achiness of her entire body.									U	10/08/1999	10/12/1999	4		UNK	UNK					U2000001480	1						1	Pain	FLU3~CONNAUGHT LABORATORIES~U0063AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162536	10/13/2000	VA	47.0	47		M	03/21/2000	3 days post vax, the pt developed fatigue, palpitations, muscle and joint pain. The pt still suffers from these symptoms but now to a lesser degree.									U	09/29/1999	10/02/1999	3		UNK	UNK					U2000001520	1						1	Arthralgia; Fatigue; Myalgia; Palpitations	FLU3~CONNAUGHT LABORATORIES~U0096BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162538	10/13/2000	NY	58.0	58		M	05/03/2000	Approximately 10 hours post vax, the pt developed neuropathy of his left leg with foot drop of the left side. Additional information is being requested. No further information is available.									U	10/19/1999				UNK	UNK					U2000002790	1						1	Neuropathy; Peroneal nerve palsy	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162539	10/13/2000	WY		44		F	04/28/2000	Following injection the pt developed severe urticaria.									U	10/26/1998				UNK	UNK					U2000002970	1						1	Urticaria	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162540	10/13/2000	AZ	23.0			F	05/17/2000	3 hours post vax, the pt developed flu-like symptoms, but no fever. The pt also experienced a nervous condition, panic attacks, and developed flu like symptoms when doing any activity. Further information has been requested.									U	10/05/1999	10/05/1999	0		UNK	UNK					U2000003440	1						1	Influenza like illness; Nervousness; Panic reaction	FLU3~CONNAUGHT LABORATORIES~U0094AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162541	10/13/2000	MT				M	06/15/2000	Sometime after the vax, the pt developed a rash that self resolved. The pt reportedly recovered from this experience.									Y					UNK	UNK					U2000004700	1						1	Rash	FLU3~CONNAUGHT LABORATORIES~U0166AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162542	10/13/2000	MT				U	06/15/2000	Sometime following the vax, the pt experienced a rash. The pt reportedly recovered from this experience									Y					UNK	UNK					U2000004710	1						1	Rash	FLU3~CONNAUGHT LABORATORIES~U0166AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162543	10/13/2000	MT				M	06/15/2000	2 days post vax, on 11/13/99, the pt developed a rash and chills that self resolved. The pt reportedly recovered from this experience.									Y	11/11/1999	11/13/1999	2		UNK	UNK					U2000004720	1						1	Chills; Rash	FLU3~CONNAUGHT LABORATORIES~U0166AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162544	10/13/2000	MT				F	06/15/2000	One day post vax, the pt developed vomiting and diarrhea lasting 24-36 hours that self resolved. The pt reportedly recovered from this experience									Y	11/18/1999	11/19/1999	1		UNK	UNK					U2000004730	1						1	Diarrhoea; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0166AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162545	10/13/2000	MT				M	06/15/2000	Sometime following the vax, the pt reports a waxy feeling, that self resolved. The pt reportedly recovered from this experience.									Y					OTH	UNK					U2000004740	1						1	Seborrhoea	FLU3~CONNAUGHT LABORATORIES~U0166AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162546	10/13/2000	MT				M	08/10/2000	One hour post vax, the pt reported feeling tired, lightheaded and had a vinegar taste in her mouth, that self resolved. The pt reportedly recovered from this experience. No additional info was provided from correspondence returned on 07/25/2000. No further info is anticipated, this case is closed.									Y	10/29/1999	10/29/1999	0		OTH	OTH					U2000004750	1						1	Dizziness; Dysgeusia; Fatigue	FLU3~CONNAUGHT LABORATORIES~U0166AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162547	10/13/2000	MT				F	08/10/2000	3 hours post vax, the pt developed hives and a rash across her shoulders posteriorly, that self resolved. The pt reportedly recovered from this experience. No additional info was provided from correspondence returned on 07/25/2000. No further info is anticipated, this case is closed.									Y	10/29/1999	10/29/1999	0		OTH	OTH					U2000004760	1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~U0166AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162548	10/13/2000	MT				F	08/10/2000	One day post vax, the pt developed aches and chills for 24 hours, that self resolved. The pt reportedly recovered from this experience. From additional correspondence received on 07/25/2000, the route and site the vaccination was administered was provided. No further info is anticipated for this repost. This case is closed.									Y	10/27/1999	10/28/1999	1		OTH	OTH					U2000004770	1						1	Chills; Pain	FLU3~SANOFI PASTEUR~U0166AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162549	10/13/2000	MT	50.0			F	08/10/2000	Sometime following the vax, the pt developed chills for 4-6 hours, that self resolved. The pt recovered from this experience. No additional info was provided from correspondence returned on 07/25/2000. No further info is anticipated, this case is closed.									Y					PVT	OTH		NONE	NONE		U2000004780	1						1	Chills	FLU3~CONNAUGHT LABORATORIES~U0166AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162550	10/13/2000	CT	67.0	67		M	08/15/2000	One day post vax, the pt developed soreness all over his body and in his joints. States he couldn't drive the car for long because of pain trying to hold onto the wheel and keep pressure on the gas foot pedal. Diagnosed with PMR. The pt was treated with medication. nine months later the pt has no relief other than with Prednisone. Pt stated he would go for a second opinion of his condition. From follow-up info received on 07/28/2000, clarification of the pt's diagnosis was provided. Pt was diagnosed with polymyalgia pheumatica. Additional pt and responsible physician information was also provided.									U	09/01/1999	09/02/1999	1		PVT	OTH		NONE	NONE		U2000005130	1						1	Arthralgia; Pain; Polymyalgia rheumatica	FLU3~CONNAUGHT LABORATORIES~U0103AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162551	10/13/2000	FL		62		F	06/18/2002	It was reported that a femal patient received a Fluzone Sc '99 -'00 vaccination on 11/16/99. Approximately 2 weeks post vax, the pt developed itching all over her body and developed a rash on her chin that spread to her vaginal area. The pt has burning over her entire body, twitching in one eye, loss of appetite, weight loss of 15 pounds, weakness and is depressed. Further information requested. Follow up #1 06/14/02: During internal auditing of all files, it was deemed necessary to amend the report (Nausea, previously reported to FDA, was inserted back into the narritive as in source document and approximate onset date provided in narritive was entered).									U	11/16/1999	11/30/1999	14		UNK	UNK					U200000537	1						1	Anorexia; Asthenia; Depression; Muscle twitching; Nausea; Pain; Rash pruritic; Weight decreased	FLU3~CONNAUGHT LABORATORIES~UO149BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0160538	10/16/2000	MI	37.0	37		F		2cm X 3cm redness with warmth present on left upper arm at injection site with pruritus. (Got shot at 11:00 on 10/10/00 and by 20:00 on 10/10/00, had 1cm of redness and itching and the irritation has increased to the above size by 10/12/00 at 14:00. Advised to apply cool compress to site and take Benadryl and Advil for itching.)									Y	10/10/2000	10/10/2000	0	NONE	PVT	PVT	Premarin, Wellbutrin, Allegra, albuterol inhaler	NONE	Allergy to grass, weeds, mold, dust, dogs, cats and pollen; asthma	Rash~Measles + Mumps + Rubella (MMR II)~~10.00~In Patient		1						1	Hypersensitivity; Injection site erythema; Injection site warmth; Pruritus	FLU3~AVENTIS PASTEUR~U0398AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0160547	10/16/2000	OH	56.0	56		F	10/05/2000	Pt stated her left upper arm got red, sore and swelled and felt hot. Pt said she felt hot. She reported this the day following the injection. Her doctor was called and she was instructed to take Tylenol. On 10/9/00, there was no redness or soreness at the injection site, only a small bruise at the injections site.									Y	10/04/2000	10/05/2000	1	NONE	OTH	PVT	NONE	NONE	Allergy to iodine			1						1	Contusion; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~MEDEVA PHARMA, LTD.~E65710MA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0160548	10/16/2000	OH	72.0	72		M	10/06/2000	Pt developed red, hard area at site of injection. On 10/6/00 when pt reported it, it was 1-1 1/2 circular red, flat area. No pain or itching or hardness. Pt had reported it to MD on 10/4/00. On 10/9/00, the pt reported there was no redness or edema at site and feels fine.									Y	10/03/2000	10/04/2000	1	NONE	OTH	PVT	Arthritis medication	NONE	Rheumatic heart valve damage as a child; CVA; Diabetes			1						1	Injection site erythema; Injection site induration; Rash	FLU3~MEDEVA PHARMA, LTD.~E65710HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0160557	10/16/2000	IL	54.0	54		F	10/03/2000	Right shoulder to halfway down arm was reddened, edematous, painful around whole arm and was warm to touch. Ice applied. Vicodin, 2 administered hs-unable to sleep. Informed client to continue ice and she takes aspirin and to call MD. MD's nurse states to continue with ice and pain medication. On 10/5/00, right arm had no soreness, edema or redness.				Y					Y	10/02/2000	10/02/2000	0		PUB	PVT	Iron pills, stool softener, Proventil, Polaramine	NONE	Allergy to pollen, grass, mold			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~MEDEVA PHARMA, LTD.~E64300HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0710K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0157382	10/17/2000	MD	60.0	60		F	09/25/2000	On 12/5/99, I began to experience eye movement pain, headaches, and congestion in my head and behind the eyes. My primary care physician treated me for a possible sinus infection, but there was no change in my symptoms. Lab work was normal, but 2 MRIs showed inflammation of the meninges. Some improvement in headaches and eye movement pain in April and May. Lately, that gain in improvement is disappearing. Vaccines are the cause of the problems I am having. They cannot determine why the meninges is inflamed.				Y					N	11/19/1999	12/05/1999	16	LT Scan of the sinuses-nml; blood tests-nml; Brain MRI-inflammation of the meninges; Spinal Tap-nml; Blood test for Lyme disease-neg; 2nd MRI in May-inflammation of the meninges.	PUB	PUB	Dilacor	NONE	Hypertension, Acid Reflux		FLU24130900	1						3	Eye pain; Headache; Nasal congestion; Eye pain; Headache; Laboratory test abnormal; Meningitis; Nasal congestion; Eye pain; Headache; Meningitis; Nasal congestion	FLU3~PARKDALE PHARMACEUTICALS~01989P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|FLU3~PARKDALE PHARMACEUTICALS~01989P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~2|FLU3~PARKDALE PHARMACEUTICALS~01989P~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUOGEN)~3	USA	Emergency room visit	Influenza
0160525	10/17/2000	MD	74.0	73		M	10/16/2000	A physician reported that a 74 year old male received an injection of Flu Shield (1999-2000 Formula) on 10/8/99. Two days later, he experienced numbness in his feet and was hospitalized. A dx of Guillain-Barre Syndrome was made. The pt was released from the hospital after 14 days and subsequently, recovered. The pt had developed a fever, generalized joint aches, headache, drowsiness, chills and generalized myalgias on 10/2/99, 6 days prior to immunization. Because a UA revealed some bacteria, the vaccine provider made a dx of possible kidney infection. However, the Urine was otherwise normal, as was a complete blood count. The pt's neurologist stated that in all likelihood, he had a viral illness on 10/2/99 and that this was more likely the cause of his Guillain-Barre Syndrome than his flu vaccine. He also stated that the onset of numbness occurred too short a time to have been related to the flu vaccine itself. The vaccine provider indicated that the pt, as of 10/9/00, complained of tingling in one foot.			Y	Y	Y	14			Y	10/08/1999	10/10/1999	2	10/99 WBC-nml; UA-some bacteria	PUB	PUB	NONE	Viral illness	UNK		HQ1946709OCT2000	1						2	Arthralgia; Bacterial infection; Headache; Hypoaesthesia; Myalgia; Pyrexia; Somnolence; Viral infection; Arthralgia; Bacterial infection; Guillain-Barre syndrome; Headache; Hypoaesthesia; Kidney infection; Myalgia; Pyrexia; Somnolence; Viral infection	FLUX~PFIZER\WYETH~4998271~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4998271~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Life Threatening,Hospitalisation	Influenza
0160613	10/17/2000	GA	38.0	38		M	10/09/2000	One hour post vax, the pt presented to ER with diaphoresis, nausea, vomiting, cough, weakness, and dizziness.				Y	Y	1			Y	10/06/2000	10/06/2000	0	CBC, basic metabolic panel	PVT	PVT		NONE	NONE			1						1	Asthenia; Cough; Dizziness; Hyperhidrosis; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~E64300HA~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0160628	10/18/2000	PA	46.0	46		F	10/11/2000	Post vax, the pt developed a local reaction of redness and induration.				Y					Y	10/03/2000	10/05/2000	2		PVT	PVT						1						1	Injection site hypersensitivity; Injection site mass	FLU3~AVENTIS PASTEUR~U0335AB~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0160632	10/18/2000	UT	37.0			F	10/10/2000	4 hours post vax, the pt developed a 10 cm circumference indurated, tender, warm area at injection site. Pt is febrile, treated with Benadryl and Prednisone.				Y					U		10/10/2000			PVT	PVT	NONE	NONE	neurofibromatosis			1						1	Injection site mass; Injection site pain; Pyrexia; Vasodilation procedure	FLU3~MEDEVA PHARMA, LTD.~E59970GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1692H~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0160639	10/18/2000	AZ	40.0			F	10/12/2000	Pt developed a red, warm, swollen area around the injection site approximately 2 inches wide and 6 inches long. Arm is extremely sore.									N	10/09/2000	10/10/2000	1		PVT	PVT		NONE	NONE			1						1	Injection site hypersensitivity; Injection site oedema; Pain; Vasodilation procedure	FLU3~MEDEVA PHARMA, LTD.~E67390KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0160640	10/18/2000	AZ	35.0			F	10/12/2000	Pt developed a red, swollen, warm area around the injection site the size of a quarter. Arm is extremely sore.									N	10/09/2000	10/10/2000	1		PVT	PVT		NONE	NONE			1						1	Injection site hypersensitivity; Injection site oedema; Pain; Vasodilation procedure	FLU3~MEDEVA PHARMA, LTD.~E67390KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0160652	10/18/2000	TN	22.0	22		M	10/18/2000	The same day as vax, the pt experienced aching in the arm from the shoulder to fingers. The pt also experienced numbness and tingling in fingers. The symptoms resolved within 15-17 hours. The pt denied any long term inpairment/numbness/tingling.									Y	10/06/2000	10/06/2000	0	NONE	OTH	PVT		NONE	allergy to tomatoes, ascorbic acid			1						1	Hypoaesthesia; Pain	FLU3~MEDEVA PHARMA, LTD.~E590806A~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0160654	10/18/2000	TX	57.0	56		F	10/03/2000	Approximately 6 hours post vax, the pt started running a high fever. The area became red, elevated and hot to the touch.				Y					N	10/02/2000	10/02/2000	0		PVT	PVT	calcium, trazodone, cozaar, synthroid, Prempro	multiple sclerosis				1						1	Injection site erythema; Injection site mass; Injection site warmth; Pyrexia	FLU3~AVENTIS PASTEUR~U0333AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0455~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0160731	10/19/2000	MI	47.0	47		F	10/16/2000	Received vaccine on 10/12/00. Pt complained of redness, swelling burning sensation and tenderness at injection site. States approx. 3-4cm in size. Symptoms first noted on 10/13/00. Treated at hospital on Sunday, 10/15/00 with Keflex.				Y					Y	10/12/2000	10/13/2000	1		OTH	PVT	NTG, atenolol, Prevacid, Vioxx, Premarin, Levoxyl, Paxil, Talwin, droperidol, Fiorinal	NONE	Mitral Valve Prolapse; heart murmur, arthritis, Thyroidism			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~MEDEVA PHARMA, LTD.~E66330HA~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0160762	10/20/2000	MI	22.0	22		F	10/22/2000	Approximately 1/2 hour post vax, the pt developed a 5-6cm erythema at the site of injection which was warm and pruritic. Was seen by an MD and advised to apply a cool compress and take Benadryl. The site was itchy all day and the rash persisted.									Y	10/10/2000	10/10/2000	0		PVT	PVT	Depakote, allergy shots, Rhinocort	NONE	allergy to mold, trees, grass pollen, Demorol, migraine headaches, endometriosis			1						1	Injection site erythema; Injection site warmth; Pruritus	FLU3~AVENTIS PASTEUR~U0398AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0160766	10/20/2000	NY	52.0			F	10/16/2000	The pt experienced erythematous reaction at injection site.									Y					PVT	PVT						1						1	Injection site erythema	FLU3~MEDEVA PHARMA, LTD.~E65630HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0160768	10/20/2000	NY	77.0	77		M	10/13/2000	The pt experienced swelling, erythema of the entire arm.									Y	10/03/2000	10/05/2000	2	CBC - nml	PVT	PVT	NONE	NONE	hypertension			1						1	Injection site erythema; Injection site oedema	FLU3~MEDEVA PHARMA, LTD.~E61756GA~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0160782	10/20/2000	IN	57.0	57		M	10/16/2000	The pt experienced redness about 2 inches in diameter at the injection sight on both arms.									Y	10/09/2000	10/10/2000	1		UNK	UNK	NONE					1						1	Injection site erythema	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0160800	10/23/2000	MD	53.0	53		F	10/20/2000	It was reported that a 53 year old female pt received a Fluzone sv '00-'01 vaccination on 10/11/00. Reportedly, that same day the pt experienced a transient ischemia attack and was admitted to the ICU of the hospital for observation.					Y				U	10/11/2000	10/11/2000	0		UNK	UNK					U2000007660	1						1	Transient ischaemic attack	FLU3~AVENTIS PASTEUR~U0336EA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0160801	10/23/2000	IL	87.0	79		M	10/20/2000	The pt experienced respiratory distress and congestive heart failure. The pt was hospitalized in ICU on a ventilator and CTB on 10/15/00. Interstitial infiltrates noted on chest x-ray by Pulmonologist.	Y				Y				N	10/10/2000	10/15/2000	5	chest x-ray - interstitial infiltrates	UNK	UNK					U2000007670	1						1	Cardiac failure congestive; Chest X-ray abnormal; Respiratory distress	FLU3~AVENTIS PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0160804	10/23/2000	IL	54.0	54		F		Client reports waking up this morning with eyes feeling funny...like when you have a fever. Also, my stomach hurts like when you're really hungry. Denies headache, muscle aches, and unable to state if fever is present. States, I know something is wrong. Client also reported having flu and td shots from primary physician earlier that day.									U	10/17/2000	10/20/2000	3	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Abdominal pain upper; Eye disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~IM~~TD ADSORBED (NO BRAND NAME)~1|YF~CONNAUGHT LABORATORIES~UA287AA~1~SC~LA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0160819	10/24/2000	NM	70.0			M	10/23/2000	Same day as vax, the pt developed complete amnesia. By the time he returned to MD's office on 10/12, he was able to recognize his wife and the MD and could correctly remember the names of his dogs. However, he was unable to recall the events of the day of the vax. He is to be evaluated by a neurologist. He has had flu shots many times before without problems.				Y					U	10/11/2000	10/11/2000	0	CT scan-nml	PVT	OTH	NONE		hx of COPD and mild hypertension		MPI2000047910	1						1	Amnesia	FLU3~MEDEVA PHARMA, LTD.~E68340HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0160839	10/24/2000	AZ	59.0	59		M	10/23/2000	Post Flu injection experienced welts on head, chest, back of neck, and one on face. Pt did not have any swelling of eyes, lips nor any wheezing or difficulty breathing.									Y	10/18/2000	10/19/2000	1		PUB	UNK	Acyclovir	Herpes	Herpes			1						1	Urticaria	FLU3~AVENTIS PASTEUR~U0337AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0160848	10/24/2000	IN	80.0	80		F	10/19/2000	Chills, myalgias, weight loss, started <24 hours after vax and weakness persisted > 2 weeks.									Y	10/05/2000	10/06/2000	1		PVT	PVT			NIDDM, CAD			1						1	Asthenia; Chills; Myalgia; Weight decreased	FLU3~AVENTIS PASTEUR~U0400AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0160872	10/25/2000	NM	55.0	55		F	10/18/2000	The evening of the vax, the pt complained of shortness of breath and requested use of inhaler. The pt's husband noted little or no relief. The pt was then transferred to bed from her motorized cart. the husband observed her to stare at the ceiling for approximately 20 seconds. She became frightened and asked him to get help. A neighbor (who happens to be a Pulmonologist) was called. He found the pt with no sinus rhythm and was unable to resuscitate her. There was no evidence of bronchospasm, no hives, and no report of audible wheezing. The death certificate lists Pulmonary arrest as cause of death. Reporting MD and Pulmonologist suspect pulmonary embolus as exact cause of death. Additional information has been requested. Follow up report received 11/07/2000: One of 2 spontaneous reports received from a physician, regarding possible adverse events associated with uses of Fluvirin, lot # H66340HA.  A 55 year old morbidly obese female (weight > 350 pounds), with a history of diabetes with diabetic neuropathics, possible transverse myelitis (recent development of neurogenic bladder control problems), and mild asthma, (requiring recent increased use of her inhalers), received vaccination with Fluvirin in October 2000.  Later that evening, patient complained of shortness of breath and requested use of inhaler.  Husband noted little or no relief.  Patient was then transferred to bed, from her motorized cart.  Husband observed her to stare at the ceiling for approximately 20 seconds.  She becaem frightened and asked him to get help.  A neighor (who happens to be a Pulmonologist) was called.  He found patient with no sinus rhythm and was unable to resuscitate her.  There was no evidence of bronchospasm, no hives, and no report of audible wheezing.  The death certificate lists Pulmonary arrest as cause of death.  Reporting MD and Pulmonologist suspect pulmonary embolus as exact cause of death.  Follow up information received, November 1, 2000 from the primary care physician.  Medical history significant for hypothyroidism, and allergies to penicillin, rvp dye, shellfish, and Tegretol.	Y	10/09/2000							N	10/09/2000	10/09/2000	0		PVT	OTH	unspecified inhaler		obesity, diabetes, diabetic neuropathies, transverse myelitis, neurogenic bladder control, asthma		MPI2000047920	1						1	Dyspnoea; Pulmonary embolism; Respiratory arrest; Sinus arrest; Staring	FLU3~EVANS VACCINES~E66340HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0160892	10/25/2000	MT	62.0	62		F	10/19/2000	Within 5 minutes of vax the pt complained of strange taste in mouth, dyspnea, anxiety, became ashen color, then cyanotic. Pulse ox decreased to 44%, pulse 140, incontence of urine, extremely restless. Complained of feeling hot. Adrenaline, nebulizer treatment with albuterol.   Transferred to ER at another medical center.					Y	1			Y	10/18/2000	10/18/2000	0		PVT	PVT	Flovent, Albuterol, Atrovent, Serevent, Prednisone, Singulair, Thro-Dur		COPD, CHF, polycythemia, asthma, allergy to Demerol			1						1	Anxiety; Cyanosis; Dysgeusia; Dyspnoea; Hypoxia; Pallor; Restlessness; Tachycardia; Urinary incontinence	FLU3~MEDEVA PHARMA, LTD.~E68800KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0690K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0160934	10/25/2000	CA	50.0	49		F	10/11/2000	Neck ache, back ache, headache and dizziness, 6 hours post vax. 24 hours later, had sore throat, malaise, dizziness and general body aches.									N	10/10/2000	10/10/2000	0	NONE	UNK	UNK	Advil	NONE	NONE			1						1	Back pain; Dizziness; Headache; Malaise; Neck pain; Pain; Pharyngolaryngeal pain	FLU3~AVENTIS PASTEUR~U0405AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0160935	10/25/2000	CA	62.0	62		F	10/16/2000	10/12/00 at noon, had onset of malaise and noticed a 2 X 3 area at injection site. It was a hot, hard lump, reddened, painful and slightly itchy. Tylenol taken. Cold compresses. Still reddened.									N	10/11/2000	10/12/2000	1	NONE	PVT	UNK	atenolol, Pravachol, Ambien, Tylenol	NONE	Hypertension, allergic to PCN and to TB test components			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site warmth; Malaise; Pruritus	FLU3~AVENTIS PASTEUR~U0405AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0160936	10/25/2000	GA	70.0	70		F	10/12/2000	Fever, chills, myalgia, rash and dry mouth, post vax. Temperature was elevated to 103F-104F X 4 days, beginning 1 day, post vax.				Y					Y	10/05/2000	10/06/2000	1		PVT	PVT	piroxicam, Macrobid	NONE	Osteoarthritis, breast cancer-NEO			1						1	Dry mouth; Myalgia; Pyrexia; Rash	FLU3~MEDEVA PHARMA, LTD.~E62690GA~7+~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0160941	10/25/2000	MO	46.0	55		F	10/16/2000	Left arm with 4 diameter red area, swollen, fever of 101F and chills X 2 days. Treated with Tylenol and rest.									Y	10/06/2000	10/07/2000	1	NONE	PVT	PVT	methotrexate, Celebrex, folic acid	NONE	Sero negative RA (Rheumatoid Arthritis)			1						1	Injection site erythema; Injection site swelling; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E66350HA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~466443~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0160942	10/25/2000	PA	69.0	69		F	10/16/2000	Post vax, pt returned to office on 10/4/00 with local signs and symptoms of cellulitis of the right arm.				Y					Y	10/02/2000	10/03/2000	1		PVT	UNK		NONE	Allergic to adhesive tape			1						1	Cellulitis; Injection site reaction	FLU3~MEDEVA PHARMA, LTD.~E61750GA~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0160948	10/25/2000	NY	76.0	76		F	10/16/2000	10/10/00, pt reported to MD that site of Pneumovax injection was red and swollen X 3 days. Advised to apply ice pack and take Tylenol.									Y	10/07/2000	10/07/2000	0		PVT	PVT		NONE	Hypertension, RHD, diabetes, GERD, Ca breast, eczema			1						1	Injection site erythema; Injection site swelling	FLU3~MEDEVA PHARMA, LTD.~E64370HA~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1216J~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0160949	10/25/2000	OR	7.0	7		M	10/12/2000	17 1/2cm X 17 1/2cm erythema and edema around left upper arm X 24 hours, post vax.				Y					U	10/09/2000	10/10/2000	1		PVT	PVT	albuterol	sinusitis	asthma			1						1	Injection site erythema; Injection site oedema	FLU3~AVENTIS PASTEUR~U0337AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0160962	10/25/2000	CA	29.0	29		F	10/18/2000	Warm to touch, tender, induration 1/2.									Y	10/17/2000	10/17/2000	0		PVT	PVT	UNK	NONE	UNK			1						1	Injection site induration; Injection site pain; Injection site warmth	FLU3~AVENTIS PASTEUR~UA405AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0160964	10/25/2000	CA	26.0	26		F	10/11/2000	1cm X 3cm raised, reddened welt, warm to touch, sensitive to touch (not painful, not itchy).									Y	10/10/2000	10/11/2000	1	NONE	PUB	PVT	Birth control pills, Ambien	NONE	NONE			1						1	Hyperaesthesia; Injection site swelling; Injection site warmth; Urticaria	FLU3~AVENTIS PASTEUR~U0405AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0160968	10/25/2000	MA	65.0	65		F	10/18/2000	2 hours, post vax, pt had shakes, light-headedness, nausea and itchy skin on whole body.									Y	10/14/2000	10/14/2000	0	NONE	PVT	PVT	Aciphex, aspirin, atenolol, Capoten, Claritin, Detrol, Lipitor, Premarin, Provera, Rhinocort, carisprodol, Demerol, Lomotil, meprobamate, Nitrostat, acetaminophen, allergy shots		Allergies tree and other pollen, dust, dust mites and molds; history of hypertension, CVA, skin ca, ulcers, sinusitis, back pain			1						1	Dizziness; Nausea; Pruritus; Tremor	FLU3~MEDEVA PHARMA, LTD.~E66340HA~UNK~IM~GM~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0160975	10/25/2000	GA	68.0	68		F	10/12/2000	Pt reported spells of difficulty raising and picking up fork, undoing clothes in arms and legs, lasting 15 minutes. Had to slide objects, multiple times a day on 9/29, 9/30 and 10/1 and only 3 times. On 10/2, had 1 episode. On 10/6, had normal exam.									Y	09/29/2000	09/29/2000	0	NONE	PVT	PVT	vitamins, Accupril, Premarin, Tranxene, Prevacid, Norvasc, Arthrotec	Sinusitis	Allergy to codeine, antihistamines			1						1	Hypokinesia; Muscular weakness	FLU3~MEDEVA PHARMA, LTD.~E65610HA~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0160978	10/25/2000	PA	32.0	32		M	10/23/2000	Pt noted rash on arms and back at 22:30 on 10/12/00, post vax. Took Benadryl. On 10/13/00, after eating seafood at 20:30, developed numbness in his tongue, tightness of his throat and hives on his neck. Treated at ER and given Benadryl, epinephrine and prednisone.				Y					Y	10/12/2000	10/12/2000	0		PVT	PVT	albuterol	NONE	Asthma			1						1	Hypoaesthesia oral; Rash; Throat tightness; Urticaria	FLU3~AVENTIS PASTEUR~U0336DA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0160983	10/25/2000	WA	56.0	56		F	11/13/2000	Severe local pain, redness, swelling; WBC 9.3/ ESR 31.				Y					Y	10/10/2000	10/10/2000	0		OTH	OTH		NONE	Diabetes Type II			1						1	Erythema; Injection site pain; Oedema	FLU3~EVANS VACCINES~58600GA~1~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0160995	10/26/2000		47.0	47		F	10/19/2000	Post vax, the pt developed erythema, edema-a localized reaction. It looked like hives around the injection site. Also, pain in arm.									Y	10/12/2000	10/13/2000	1		PVT	PVT	Atenolol, HCTZ	NONE	NONE		ND0013	1						1	Injection site erythema; Injection site oedema; Pain; Urticaria	FLU3~AVENTIS PASTEUR~U0333AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161001	10/26/2000	NY	2.0	2	.9	M	10/19/2000	Next morning post vax, the pt awoke with a fever of 101. Also, erythema and edema on right arm extending from sternum down to right arm to antecubital space. Pruritic in nature with slight tenderness to the touch.				Y					Y	10/10/2000	10/11/2000	1	blood culture-neg, CBC-wnl	OTH	UNK	AZT, Flovent, Albuterol		HIV, asthma			1						1	Injection site erythema; Injection site oedema; Pain; Pruritus; Pyrexia	FLU3~AVENTIS PASTEUR~U0386AB~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0161010	10/26/2000	NJ	44.0	44		F	10/25/2000	12 hours post vax, the pt developed severe nausea, itching, and redness with a papular rash. Self treated with Benadryl.									Y	10/19/2000	10/20/2000	1		PUB	OTH	NONE	NONE	NONE			1						1	Erythema; Nausea; Pruritus; Rash papular	FLU3~AVENTIS PASTEUR~U0346AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161011	10/26/2000	ME	78.0			M	10/25/2000	Rash on back, stomach, scratching arms. Given Benadryl to relieve symptoms.									Y	10/24/2000	10/24/2000	0		OTH	PUB	Dilantin	NONE	stroke, seizure			1						1	Rash	FLU3~MEDEVA PHARMA, LTD.~E599606A~4~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161013	10/26/2000	PA	86.0	86		M	10/24/2000	Post vax, the physician reported that on 10/10/00, the pt just wasn't himself. Pt claimed it was the Flu shot that made him ill, however, the doctor believes pt was passing a gallstone. The pt was hospitalized on 10/11/00, for acute hepatic injury, gallstones is the dx. Additional information received on 10/16/00, states that the reporting physician reaffirmed his belief that pt's symptoms were secondary to passage of a gallstone.					Y				U	10/08/2000	10/10/2000	2	bilirubin and transaminase-decreased	OTH	OTH	Lipitor, Prilosec, aspirin, hydroxyzine, Detrol		hypercholesterolemia, aortic stenosis		MPI2000047980	1						1	Cholelithiasis; Laboratory test abnormal; Malaise	FLU3~MEDEVA PHARMA, LTD.~E64490HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0161032	10/27/2000	PA	38.0	38		F	10/13/2000	Same day post vax, the pt was unresponsive; staring (not unconscious). Pt seemed unable to speak. When she was able to speak, she complained of heaviness of arm and legs, unable to move legs. Stated she felt a little tightness in her chest and nausea. She was taken to ER and then discharged home. The next day she was absent from school and states she felt weak and tired.				Y					Y	10/09/2000	10/09/2000	0	EKG, blood work, UA	OTH	PVT		NONE	NONE			1						1	Aphasia; Asthenia; Chest discomfort; Nausea; Sensation of heaviness; Staring	FLU3~AVENTIS PASTEUR~U0335AB~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0161033	10/27/2000	NY	49.0	49		F		Post vax, the pt developed pain and redness at injection site.									Y	10/03/2000	10/04/2000	1		PVT	PVT	NONE	NONE	NONE			1						1	Injection site hypersensitivity; Injection site pain	FLU3~AVENTIS PASTEUR~U0335AD~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161034	10/27/2000	NY	23.0	22		F	10/20/2000	Post vax, the pt developed a 12 cm cellulitis at injection site. The site was red, hot, and hard for 48 hours.									Y	10/04/2000	10/05/2000	1	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Cellulitis; Injection site hypersensitivity; Vasodilation procedure	FLU3~AVENTIS PASTEUR~U0335AB~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161035	10/27/2000	NY	43.0	43		F	10/20/2000	Post vax, the pt developed cellulitis at injection site. Area was red, hot, and hard for 48 hours.									Y	10/04/2000	10/05/2000	1	NONE	PVT	OTH		NONE	NONE			1						1	Cellulitis; Injection site hypersensitivity; Vasodilation procedure	FLU3~AVENTIS PASTEUR~U0335AB~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161036	10/27/2000	NY	23.0	23		F	10/20/2000	10 cm cellulitis at injection site. Red, hot, and hard for 48 hours.									Y	10/04/2000	10/05/2000	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Cellulitis; Injection site hypersensitivity; Vasodilation procedure	FLU3~AVENTIS PASTEUR~U0335AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161037	10/27/2000	MI	6.0	6		M	10/21/2000	Post vax, the pt developed swelling, fever, and achiness.									Y	10/12/2000	10/12/2000	0		PVT	UNK		NONE	NONE			1						1	Pain; Pyrexia; Swelling	FLU3~AVENTIS PASTEUR~U0403AA~5~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~474938~1~IM~RL~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0161038	10/27/2000	NY	46.0	46		F	10/19/2000	5 minutes post vax, the pt began scratching left arm and pt developed a baseball sized area of erythema. Given Benadryl to relieve symptoms.									Y	10/19/2000	10/19/2000	0		PVT	PVT	Premarin, folate, methotrexate	NONE	Sjogren's syndrome, HTN			1						1	Erythema	FLU3~AVENTIS PASTEUR~U0333AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0944K~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0161041	10/27/2000	OH	82.0	82		F	10/23/2000	Pt received flu vax on 10/19/00. She expired in her sleep on 10/20/00.	Y	10/20/2000							N	10/19/2000	10/20/2000	1		PVT	OTH			CAD, DM, HTN, MI, CVA			1						1	Unevaluable event	FLU3~AVENTIS PASTEUR~U0335AB~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0161051	10/27/2000					U	10/20/2000	Same day post vax, the pt developed fine rash on palms, arms, and back. Pt also had paresthesia of hands and feet.									Y	10/16/2000	10/16/2000	0	NONE	UNK	UNK						1						1	Paraesthesia; Rash	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0161071	10/30/2000	IN	27.0	27		M	10/17/2000	30-45 minutes post vax, the pt experienced episodes of vomiting times 3 lasting 15 minutes. No rash or redness noted at site or elsewhere on body. No other symptoms.									Y	10/17/2000	10/17/2000	0		OTH	PVT	NONE	vomiting	NONE			1						1	Vomiting	FLU3~AVENTIS PASTEUR~U0402BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161075	10/30/2000	WA	46.0	46		F	10/20/2000	3 hours post vax, the pt developed a red, swollen, itchy arm.									Y	10/16/2000	10/16/2000	0		PVT	PVT	Norvasc, Tegretol, Synthroid, iron	NONE	allergy to codeine, Erythromycin, and Zithromax, HTN, diabetes, CVA			1						1	Erythema; Pruritus; Swelling	FLU3~AVENTIS PASTEUR~U0402BA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0820K~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0161078	10/30/2000	FL	67.0	67		F	10/20/2000	Post vax, the pt developed local redness, heat, and erythema.				Y					U	10/17/2000				PVT	PVT	Lotensin, Baycol	NONE	hypertension, hyperlipidemia			1						1	Injection site erythema; Injection site hypersensitivity; Vasodilation procedure	FLU3~MEDEVA PHARMA, LTD.~E64670HA~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1217J~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0161083	10/30/2000	KY	70.0	70		M		Post vax, the pt had a warm feeling in lower extremities, nausea, mild dyspnea. Resolved over 1 hour after Benadryl.				Y					Y	10/19/2000	10/19/2000	0	glucose-282, pulse ox-95%	PVT	UNK		NONE	diabetes, CAD, hyperlipidemia			1						1	Dyspnoea; Nausea; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E68790KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0161091	10/30/2000	MO	35.0	35		F	10/16/2000	Same day post vax, the pt developed pain in right arm pit radiating through to right breast. Later that night, the pt developed pain at the injection site as well. On 10/13, the pt developed a fever of 103, body aches, pain at site, and red patch at injection site, and weakness. Pt seen by physician and treated with prednisone and antibiotics. 11/3/00 client states she has not had any further treatment. Dr. visits, etc. since 10/13 and 16/16 visits. States R delt has 1 1/2 knot and still a little tender.				Y					Y	10/12/2000	10/12/2000	0		PUB	PUB	Zestoretic, Synthroid, Glucophase	NONE	allergic to codeine, diabetes, Crohn's disease, hypertension			1						1	Asthenia; Breast pain; Injection site hypersensitivity; Injection site pain; Pain; Pyrexia; Skin nodule; Tenderness	FLU3~MEDEVA PHARMA, LTD.~E59270GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0690K~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0161094	10/30/2000	NY	35.0			F	10/27/2000	Pt was administering flu vax during a flu clinic on 10/27/00; she inadvertently got excess vaccine spray on her right arm. Approximately 30 minutes later, she noted red, hot, itchy area on arm. She washed the area with soap and water and applied hydrocortisone cream.									Y					UNK	UNK						1						1	Erythema; Pruritus; Vasodilation procedure	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0161095	10/30/2000	TX	44.0	44		F	10/27/2000	Same day post vax, the pt began to have tightness in chest, coughing, aching, wheezing, weakness, fast heart rate, and dizziness. EMS gave Benadryl and Albuterol treatments.									Y	10/26/2000	10/26/2000	0	NONE	PUB	PUB		NONE	NONE			1						1	Asthenia; Chest discomfort; Cough; Dizziness; Heart rate increased; Pain; Wheezing	FLU3~AVENTIS PASTEUR~U0410AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162745	10/30/2000	FL	68.0			F	10/02/2000	Following injection of Flu Shield (1997-1998) and subsequently developed an injection site reaction characterized by a large area of redness and itching. She recovered.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ6778302JUN2000	1						1	Injection site erythema; Pruritus	FLU3~PFIZER\WYETH~~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0162746	10/30/2000	CA	62.0			F	08/08/2000	The pt experienced a headache. She recovered.									Y					OTH	OTH				headache, upper lip numbness, facial edema, jaw pain~Influenza (Seasonal) (no brand name)~2~0.00~In Patient	HQ8219506JUL2000	1						1	Headache; Similar reaction on previous exposure to drug; Vaccine positive rechallenge	FLU3~PFIZER\WYETH~~3~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0162873	10/30/2000	GA	6.0	6		M	07/19/2000	A mother reported that her 6 year old son received an injection of Flu-Shield (1997-1998 Formula) in September, 1997. Within 20 minutes, post vax, he developed generalized hives. He recovered.									Y	10/08/1997	10/08/1997	0	UNK	PVT	OTH	UNK	NONE	bronchospasm NOS, hypersensitivity NOS		HQ7195012JUN2000	1						1	Hypersensitivity; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0161128	10/31/2000	NE	47.0	47		F	10/26/2000	2 hours, post vax, had increased temperature, chills and body aches; temperature increased to 100.4F that lasted 2 hours and chills continued through evening. Had some body aches today, 10/26/00, and chills with decreased temperature.									Y	10/25/2000	10/25/2000	0	NONE	PUB	PVT		NONE	NONE			1						1	Pain; Pyrexia	FLU3~AVENTIS PASTEUR~U0403AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161138	10/31/2000	TX	54.0	52		M	10/23/2000	Pt reportedly received pneumococcal vaccine and subsequently, developed lobar pneumonia (RML), 2 years later. Vaccine failure?									Y	10/24/1998	10/02/2000	709		OTH	OTH						1						1	Lobar pneumonia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0870H~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0161140	10/31/2000	IA	53.0	53		F	10/23/2000	Approx. 3 hours, post vax, pt developed body aches, pain and a temperature of 100.2F (orally). Examined by physician, 2 days later, and instructed bed rest and Tylenol.				Y					Y	10/17/2000	10/17/2000	0	NONE	PVT	OTH	tamoxifen, trazodone, Serevent, Zantac, Benadryl and various herbs		CA of breast, history of asthma, allergy to ibuprofen			1						1	Pain; Pyrexia	FLU3~AVENTIS PASTEUR~U0336AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0161145	10/31/2000	ME	29.0	29		F	10/26/2000	Respiratory tightness around 16:00, hard to breathe in-felt need to breathe out with fatigue. Around 20:00, awoke from nap with cough, lungs felt on fire. In the AM, lungs felt irritated, throat felt irritated, and had cough. No self treatment. On 10/26/00, at 14:00, given Zyrtec.									N	10/25/2000	10/25/2000	0	NONE	OTH	PUB	Zocor	Rhinitis	NONE			1						1	Chest discomfort; Cough; Dyspnoea; Pharyngolaryngeal pain	FLU3~MEDEVA PHARMA, LTD.~E61760GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161235	11/01/2000	VT	52.0	44		M	10/24/2000	30 minutes post vax, the pt developed pounding headache and sweating. One hour post vax, the pt had headache only. 2 hours post vax, the pt had no symptoms.									Y	10/23/2000	10/23/2000	0		PVT	OTH	Prilosec, Lipitor, Bentyl, Lopressor	NONE				1						1	Headache; Hyperhidrosis	FLU3~MEDEVA PHARMA, LTD.~E67360KA~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161239	11/01/2000	NV	69.0	69		F	10/25/2000	Same day post vax, the pt developed redness and itching on both inner thighs. By the next evening, the entire inner thigh was covered with red almost port wine stain with raised welts, hives, and intense itching. Went to urgent care and received Benadryl IM.				Y					Y	10/03/2000	10/03/2000	0		OTH	OTH	Lescol	NONE	allergy to PCN, tetanus, erythromycin			1						1	Erythema; Pruritus; Urticaria	FLU3~AVENTIS PASTEUR~U0334AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0161240	11/01/2000	TX	52.0	52		F		Post vax, the pt developed swollen area 2 x 3 1/2 inches, redness, soreness, and warm to the touch.									Y	10/12/2000	10/13/2000	1	NONE	OTH	OTH	Synthroid, Diavan HC, Zocar, Wellbutrin	NONE				1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Vasodilation procedure	FLU3~AVENTIS PASTEUR~U0403AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161244	11/01/2000	WV	27.0	27		F	10/25/2000	Post vax, the pt had onset of redness and blistering at site of tetanus injection. Area of redness was 12 cm x 8 cm on upper arm. Blister area was 2 x 1 1/2 cm with approximately 20 smaller blisters inside the erythematous area.				Y					Y	10/16/2000	10/18/2000	2		PVT	UNK		NONE	exercise-induced asthma, psoriasis, bipolar depression			1						1	Blister; Injection site hypersensitivity	FLU3~MEDEVA PHARMA, LTD.~E626906GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~LEDERLE LABORATORIES~466028~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0161246	11/01/2000	VA	75.0	75		F	10/26/2000	2 hours post vax, the pt experienced swelling at site with redness. By bedtime swelling increased as well as extension of redness and site on left deltoid became very tender. Also, she describes feeling listless. Unable to lay on left side during the night due to pain.				Y					U	10/25/2000	10/25/2000	0	NONE	PVT	PVT	K-Dur, Lozol, Trazodone, Prilosec	NONE	allergy to all antibiotics, fibromyalgia, HTN			1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Listless	FLU3~AVENTIS PASTEUR~U0345AC~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0945K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0161253	11/01/2000	ID	23.0	23		F	10/25/2000	Within 6 hours post vax, the pt developed left arm numbness/tingling. Dx as possible brachial plexus neuropathy. Pt started on NSAIDS, ulnar support/protection.									U	10/12/2000	10/12/2000	0		PUB	PUB	Norplant, Effexor		seasonal allergies			1						1	Hypoaesthesia; Neuropathy peripheral	FLU3~AVENTIS PASTEUR~U0403AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161254	11/01/2000	ID	29.0	29		M	10/25/2000	8 hours post vax, the pt developed hives. The hives resolved without treatment. Self-treated with Benadryl.									Y	10/13/2000	10/13/2000	0		PUB	PUB						1						1	Urticaria	FLU3~AVENTIS PASTEUR~U0403AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161259	11/01/2000	MO	69.0	69		F	10/25/2000	Post vax, the pt developed itching, redness, and swelling at site of injection.				Y					U	10/24/2000	10/25/2000	1		PVT	PVT						1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~AVENTIS PASTEUR~U0403AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0161260	11/01/2000	SC	65.0	65		M	10/25/2000	3 weeks post vax, the pt developed polymyalgia rheumatica.				Y					Y	11/03/1999	11/26/1999	23	sed rate, Lyme serology	PVT	UNK	Humulin, Glucophage, Vasotec		diabetes (insulin-dependent)			1						1	Polymyalgia rheumatica	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0161264	11/01/2000	MO	31.0	41		F	10/25/2000	24 hours post vax, the pt developed pruritus, swelling, and redness at injection site. 27 hours post vax, the pt developed a rash on chest, lightheaded, and nauseous.				Y					Y	10/24/2000	10/25/2000	1		PVT	PVT	Allegra D, Synthroid, progesterone, allergy shots		allergic rhinitis, hypothyroidism			1						1	Dizziness; Injection site hypersensitivity; Injection site oedema; Nausea; Pruritus; Rash	FLU3~AVENTIS PASTEUR~U0403AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0161213	11/02/2000	NC	46.0	45		F		Rash on neck, 26 1/2 hours, post vax. Took Benadryl (self prescribed).									Y	10/27/2000	10/28/2000	1		OTH	PVT	NONE	NONE	NONE			1						1	Rash	FLU3~MEDEVA PHARMA, LTD.~E68790KA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161222	11/02/2000	PA	37.0	37		F	10/24/2000	Fever to 101F, nausea, dizziness and muscle ache at site of injection with some fine rash. Reaction started 10/6/00.									Y	10/05/2000	10/06/2000	1		PVT	PVT		NONE	Allergic to Keflex; causes GI symptoms; Asthma			1						1	Dizziness; Injection site pain; Injection site rash; Myalgia; Nausea; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E64370HA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0042J~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0161266	11/02/2000	AR	87.0	87		M	10/25/2000	Swelling over time on right shoulder (urticarial in origin). Fluid collected over time of the right elbow. There were no signs of infection and movement of elbow remained normal.				Y					Y	10/11/2000	10/11/2000	0		PUB	UNK			COPD, CHF, HTN and bladder cancer			1						1	Joint effusion; Swelling; Urticaria	FLU3~AVENTIS PASTEUR~U0405AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0161273	11/02/2000	MA	47.0	47		M	10/28/2000	Local reaction with cellulitis appearing about 36 hours, post vax, consisting of an area of induration and erythema measuring 2 1/2cm X 7 1/2cm; cellulitis with a 9cm streak going into axilla.									Y	10/26/2000	10/28/2000	2	NONE	PUB	UNK		NONE	Codeine			1						1	Cellulitis; Injection site erythema; Injection site induration	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0161274	11/02/2000	PA	65.0	65		F	10/30/2000	10 minutes, post vax, pt reports tingling feeling in cheeks and up back of neck. BP-L 142/90; R 134/90. Pt reported she had no breakfast prior to IZ. Stayed in clinic until 10:55 and stated she felt better and wanted to get breakfast. Advised to seek medical attention if symptoms persisted. Called at 15:00, pt attending art class per husband.									Y	10/27/2000	10/27/2000	0	NONE	PUB	PUB	E-Vista, Toprol, vitamins	NONE	Hypertension			1						1	Hypertension; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E59250GA~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161286	11/02/2000	NY	54.0	54		M	11/01/2000	A few hours, post vax, pt felt nauseous. On 11/1/00, noticed a welt at injection site without itch or discomfort. A few hours later, the 1 diameter welt, disappeared.									Y	10/30/2000	10/30/2000	0		MIL	PUB		NONE				1						1	Hypersensitivity; Nausea; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E67400KA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161287	11/02/2000	OH	33.0	33		F	11/01/2000	From 10/10/00 to 10/13/00, had extreme aching in arm, extreme fatigue, unable to lift arm (stiff) and tingling/aching neck and arm with 2cm-3cm lump at site. Instructed to follow-up with PCP.									Y	10/10/2000	10/10/2000	0	NONE	PVT	PVT	Allegra, Flovent, Pantanol, Proventil HFA	NONE	Allergic rhinitis, conjunctivitis, asthma			1						1	Fatigue; Hypokinesia; Injection site mass; Musculoskeletal stiffness; Neck pain; Pain; Paraesthesia	FLU3~AVENTIS PASTEUR~U0399BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161288	11/02/2000	NY	45.0	45		M	11/01/2000	Pt complained of arthralgia, fever, chills and welt at site on 10/30/00. Told to take fluids and Tylenol. Called on 11/1/00 and requested visit as arthralgia was worsening. Does not have fever or chills. Slight lump at injection site. NAD.				Y					Y	10/25/2000	10/27/2000	2		MIL	PUB		NONE	NONE			1						1	Arthralgia; Injection site induration; Pyrexia; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E67400KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0161290	11/02/2000	OH	73.0	73		F	11/01/2000	10/11/00, generalized rash and itching. Pt never followed-up with PCP.									U	10/10/2000	10/11/2000	1	NONE	PVT	PVT	Toprol XL, Gamma Knife TXS, HCTZ,	NONE	Asthma, HTN, Arthritis, Meningioma			1						1	Pruritus; Rash	FLU3~AVENTIS PASTEUR~U0399BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161323	11/03/2000	MI	63.0	63		F	10/09/2000	Same day post vax, the pt developed a fever and a few blotches on arms, legs, face, and neck.									N	10/05/2000	10/05/2000	0		PUB	PUB			diabetes, allergy to PCN, sulfa, codeine, Darvan, ASA, ampicillin		MI2000077	1						1	Pyrexia; Rash macular	FLU3~MEDEVA PHARMA, LTD.~64300~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161343	11/03/2000	CT	41.0	41		F	10/30/2000	Post vax, the pt developed a 2 1/2 x 2 1/2 inch area of redness, raised with edema, and hot to the touch.									Y	10/25/2000	10/26/2000	1		PVT	PVT	NONE	NONE				1						1	Injection site hypersensitivity; Injection site oedema; Vasodilation procedure	FLU3~MEDEVA PHARMA, LTD.~E64710HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161344	11/03/2000	CT	29.0	29		U	10/30/2000	Post vax, the pt developed a 2 inch x 2 inch hematoma, hard, hot to the touch with edema.									Y	10/25/2000	10/26/2000	1		PVT	PVT	NONE	NONE	environmental allergies, cats, dogs			1						1	Injection site haemorrhage; Injection site mass; Injection site oedema; Vasodilation procedure	FLU3~MEDEVA PHARMA, LTD.~E64710HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0153405	11/06/2000	MD	50.0	50		F	06/09/2000	A nurse reported that a 50 year old female employee received an injection of Flu Shield '99-'00 on 10/18/99 and immediately developed an injection site reaction characterized by a hot, ache feeling and a sore arm. She also experienced weakness of her left arm. The pt was seen by a physician on 4/24/00 and an MRI of her left arm was ordered; however, the results were not available at the time of the report. Follow-up information received from the vaccine provider on 5/26/00, indicated that the pt experiences weakness when she raises her left arm in a perpendicular position. However, the pt states that she is able to lift children with no discomfort.									U	10/18/1999	10/18/1999	0	MRI-pending	PVT	PVT	UNK	NONE	UNK		HQ4918428APR2000	1						2	Feeling hot; Injection site pain; Pain; Asthenia; Injection site pain; Injection site warmth; Pain	FLU3~PFIZER\WYETH~4999265~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4998265~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0159724	11/06/2000	CA	64.0	64		F	08/08/2000	Immediately following vax, the pt experienced numbness of her upper lip, a headache, fluttering in her chest, a full feeling in her face, and aching jaws. The pt recovered within 4 to 5 days. The pt reported similar experiences following receipt of Marcaine and Carbocaine. She attributed these events to a salt derivative or preservative found in each product. The pt reported undergoing thyroidectomy in 1996 and reported experiencing viral infection attack on the nervous system in 1984.									Y	10/05/1999	10/05/1999	0	UNK	OTH	PUB	UNK	UNK	drug hypersensitivity; Thyroidectomy NOS; Viral infection NOS		HQ6982407JUN2000	1						2	Headache; Atrial flutter; Headache; Hypoaesthesia oral; Pain in jaw	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0161356	11/06/2000	NY				F	11/02/2000	Five minutes post vax, this pt's arm became red, warm swollen and itchy. Area encompassed approximately 10cm x 7 cm.									U					PVT	UNK	Glucotrol, Glucophage, Cozaar, Lipitor, Lasix, Prozac, Coumadin		Iodine and Codeine allergies			1						1	Feeling hot; Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~CONNAUGHT LABORATORIES~U0337AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161358	11/06/2000	CT	48.0			F	10/27/2000	Red 4 inch diameter area at injection site occurred same day post vax. It was itchy, red, and warm to touch.									Y	10/25/2000	10/25/2000	0		PVT	UNK						1						1	Injection site hypersensitivity; Pruritus; Vasodilation procedure	FLU3~MEDEVA PHARMA, LTD.~E66350HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161361	11/06/2000	PA	74.0	74		F	11/29/1999	Had flu vax on 10/12. Seven days post vax, on 10/19, cough, strangulation cough, questionable bronchitis, non productive. Every time vaccinee was active or talked, she would experience shortness of breath resulting in cough. She is still seeing physician.				Y					U	10/12/1999	10/19/1999	7	Pulmonary function test, echocardiogram, CAT scan, CXR - no pneumonia. Endoscopy and bronchoscopy were scheduled for 12/9/99.	PVT	OTH	tamoxifen, atenolol	NONE	Allergy to Flagyl, Bactrim, ASA, Naprosyn		PA9979	1						1	Bronchitis; Cough; Dyspnoea	FLU3~PFIZER\WYETH~4998262~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0161363	11/06/2000	NE	54.0	54		F	10/30/2000	Twenty-four hours post vax, arm ached, progressively worse, joints ached all over, arm swollen, hot and red. Knot in arm size of marble. Unable to lift arm.									U	10/26/2000	10/27/2000	1		PVT	PVT	Prempro, Zocor, Wellbutrin, Zoloft	Runny nose, slight cough	Depression			1						1	Arthralgia; Erythema; Hypokinesia; Injection site mass; Oedema peripheral; Pain; Vasodilatation	FLU3~MEDEVA PHARMA, LTD.~E59960GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161375	11/06/2000	MI	16.0	16		F	10/30/2000	The pt experienced itching on 10/21/00, no hives. 10/22/00 told mother hives on extremities and on body. Seen at a walk-in clinic. MD ordered arthritis screen, metabolic panel and CBC. All labs were negative per mother with the exception of Sed Rate that was elevated. The pt was treated with Prednisone, Zyrtec and Vioxx. Was advised to consult a rheumatologist. It was felt that the symptoms were due to the vaccine.				Y					Y	10/20/2000	10/21/2000	1	arthritis panel, metabolic panel, CBC	OTH	PVT	Zyrtec	NONE	allergies			1						1	Pruritus; Red blood cell sedimentation rate increased; Urticaria	FLU3~AVENTIS PASTEUR~U0403AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0161377	11/06/2000	NY	44.0	44		M	10/29/2000	The pt experienced redness and warmth at and below the injection site on the right arm.				Y					U	10/27/2000	10/27/2000	0	CBC and diff	PVT	UNK		NONE	asthma			1						1	Injection site erythema; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0161385	11/06/2000	UT	53.0	53		F	10/31/2000	About 1 1/2 hours post vax, the pt began having hives/itchy rash, mils shortness of breath and cough for about 4 hours post vax.									U	10/26/2000	10/26/2000	0		UNK	UNK	Flovent, Serevent, albuterol, nasarel		asthma, seasonal allergies, rhinitis, allergy to sulfa			1						1	Cough; Dyspnoea; Pruritus; Rash; Urticaria	FLU3~AVENTIS PASTEUR~U0337AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163230	11/06/2000	FL	49.0			F	05/09/2000	Subsequent to receiving vax the pt developed aches and pains described as mainly joint pain.									U				UNK	MIL	MIL	Albuterol; Azmacort; Celecoxib; Clonidine; Guafenesin; Prempro; Prilosec; Serevent; Slo-Bid; vitamins	NONE	UNK		HQ2572110APR2000	1						1	Pain	FLU3~PFIZER\WYETH~4998236~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163231	11/06/2000	KS	20.0			M	06/06/2000	Pt inadvertently received 5.0cc of Flu Shield (1999-2000 Formula). One day post vax the pt developed a fever 101F, aching, nausea and vomiting. Additional information received from the physician on 06/05/2000, indicated that the pt recovered within 2 to 3 days.									Y	04/13/2000	04/14/2000	1	UNK	OTH	OTH	UNK	NONE	UNK		HQ3832220APR2000	1						1	Nausea; Pain; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163232	11/06/2000	FL	70.0			F	07/06/2000	Subsequent to receiving vax the pt developed an injection site reaction characterized by a large area of redness and itching. She also developed an egg type lump between her neck and shoulder, which felt like a big ball that swelled. A red streak went from her neck to the top of her shoulder. She recovered without treatment.									Y				UNK	PVT	PVT	aspirin; Levothyroxine; meprazole; Premarin; Simvastatin; vitamins	UNK	UNK		HQ5726111MAY2000	1						1	Cellulitis; Injection site erythema; Pruritus; Skin nodule	FLU3~PFIZER\WYETH~~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0161416	11/07/2000	IL	79.0	79		M	11/02/2000	It was reported that a 79 year old male pt received a Fluzone SV '00-'01 vaccination on 10/10/00. Reportedly, the pt developed respiratory distress and congestive heart failure. The pt was hospitalized in ICU on a ventilator and cease to breath on 10/15/00. Interstitial infiltrates notes on chest X-ray by Pulmonologist. Follow-up from 10/24/00, upon further evaluation is was discovered that the pt died on 10/15/00. Follow-up correspondence received on 11/2/00, it was reported that the pt died on 10/16/00 not on 10/15/00 as previously reported. Additional pt and responsible physician information were also provided.	Y	10/16/2000			Y	5			N	10/10/2000	10/15/2000	5	Chest X-ray-interstitial infiltrates noted.	OTH	UNK		CHF; pneumonia			U2000007672	1						1	Apnoea; Cardiac failure congestive; Chest X-ray abnormal; Respiratory distress	FLU3~AVENTIS PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0161420	11/07/2000	MD	53.0	53		F	11/02/2000	On 10/11/00, the pt received the vaccines, reportedly on the same day, the pt experienced a transient ischemia attack and was admitted to the ICU of the hospital for observation. From a follow-up correspondence received on 11/1/00, it was reported that the pt was hospitalized for 4 days. The pt's recovery status is unknown.					Y	4			U	10/11/2000	10/11/2000	0		PUB	UNK		NONE			U2000007661	1						1	Transient ischaemic attack	FLU3~AVENTIS PASTEUR~U0336EA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0161522	11/07/2000	OR	68.0	68		M	10/27/2000	Severe myalgias posterior neck, thoracic and lumbar; clear coryza, sneezing X 1 week.				Y					Y	10/19/2000	10/20/2000	1	NONE	PVT	OTH	digoxin	COPD	COPD, HTN, PAT, B12 deficiency, Glucose intolerance			1						1	Myalgia; Rhinitis; Sneezing	FLU3~AVENTIS PASTEUR~U0403AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0161531	11/07/2000	OK	26.0	26		F	11/03/2000	Nausea the 1st day; 2nd day and continuing with fever, chills, sore arm, red and swollen injection site. Tightness in chest, problems sleeping, congested cough, sore throat. Have only taken Tylenol and Tylenol PM, using heating pad on injection site.									U	11/01/2000	11/01/2000	0		PVT	UNK	ProAmatine, Prometrium	Asthma, endometriosis, hypotension				1						1	Chest discomfort; Cough; Injection site erythema; Injection site pain; Injection site swelling; Insomnia; Nasal congestion; Nausea; Pharyngolaryngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0161533	11/07/2000	MI	34.0	34		F	10/30/2000	Began developing symptoms during the day and by evening, entire upper arm was red, warm to touch, swollen, itchy and burning. Given Keflex and Zyrtec. Re-examined on 10/30/00 and much improvement with just slight redness and itching. States continues to improve.				Y					Y	10/25/2000	10/25/2000	0	NONE	PUB	PVT	UNK	UNK	Med allergies; Motrin, Macrodantin			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Pruritus	FLU3~AVENTIS PASTEUR~U0399EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0161537	11/07/2000	SC	33.0	33		F	10/26/2000	15 minutes, post vax, had swelling and pain in left hand and wrist. These symptoms gradually resolved but hand and wrist remained sore the next day. Pt seen on 10/24/00 and mild swelling on dorsum of hand observed. No swelling or erythema at injection site. This is the 2nd pt with such complaints after flu shot.									Y	10/23/2000	10/23/2000	0		PUB	PVT	Lamisil, oral contraceptive, Zoloft, BuSpar, Sudafed	NONE	Depression, skin condition (fungal)			1						1	Oedema peripheral; Pain	FLU3~MEDEVA PHARMA, LTD.~E70210KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161541	11/07/2000	MA	41.0	41		F	11/01/2000	Hives across back requiring several doses of Benadryl.									Y	10/26/2000	10/27/2000	1	NONE	PVT	PUB	Flovent, Serevent, albuterol	NONE	Asthma			1						1	Urticaria	FLU3~AVENTIS PASTEUR~U0346AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161548	11/07/2000	UT	69.0	69		F	10/31/2000	Bell's Palsy, 30 minutes, post vax.				Y					U	10/17/2000	10/17/2000	0		PVT	PVT	Prilosec, Synthroid, Digoxin, Coumadin, Insulin	NONE	Diabetes, atrial fibrillation			1						1	Facial palsy	FLU3~AVENTIS PASTEUR~U0337AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0161552	11/07/2000	IL	71.0	71		F	10/28/2000	Pt's arm became very sore and swollen and had a fever (unknown exact temp).									Y	10/26/2000	10/26/2000	0		PVT	PVT			History of breast cancer (left) and increased cholesterol			1						1	Injection site pain; Injection site swelling; Pyrexia	FLU3~AVENTIS PASTEUR~U0334AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161553	11/07/2000	MN	27.0	27		F	11/01/2000	Dizziness, nausea and vomiting, 10-15 minutes, post vax. Went to ER at 01:00 with temperature of 102F, shortness of breath and stayed until 07:00 Saturday on 10/28/00. Reports not knowing she is allergic to eggs, until now.				Y					Y	10/27/2000	10/27/2000	0		OTH	OTH	NONE	NONE				1						1	Dizziness; Dyspnoea; Hypersensitivity; Nausea; Pyrexia; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E64700HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0161554	11/07/2000	PA	15.0	15		M	10/30/2000	Area of tenderness, erythema and warmth.									U	10/27/2000	10/28/2000	1	NONE	PVT	OTH	NONE	Sinusitis	Bronchial asthma, stable on alberterol			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~AVENTIS PASTEUR~U0416DA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1687J/1011K~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0161557	11/07/2000	WA	52.0	52		F	10/17/2000	Injection site turned red, welted, warm to touch approx 2 wide and remained very sensitive to touch for 48 hours.									Y	10/13/2000	10/14/2000	1	NONE	MIL	MIL	NONE	NONE				1						1	Injection site erythema; Injection site pain; Injection site warmth; Urticaria	FLU3~MEDEVA PHARMA, LTD.~80929~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161558	11/07/2000	WA	35.0	35		F	10/17/2000	Red welt about 1 across, tender on palpation and red welt from 10/13/00 to 10/15/00; faded to bruise-like discoloration. On 10/17/00, still have discoloration and still sensitive.									Y	10/13/2000	10/13/2000	0	NONE	MIL	MIL	NONE	Cold symptoms	Allergic to Septra and Polytrim			1						1	Injection site pain; Skin discolouration; Urticaria	FLU3~MEDEVA PHARMA, LTD.~80929~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161559	11/07/2000	WA	24.0	24		M	10/17/2000	Sudden onset of a major headache for 1.5 hours, post vax. Pain sat right behind right eye for 2 1/2 to 3 days. Sick in quarters X 24 hours. No other problems.									Y	10/13/2000	10/13/2000	0	NONE	MIL	MIL	vitamins	NONE				1						1	Headache	FLU3~MEDEVA PHARMA, LTD.~80929~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161560	11/07/2000	WA	38.0	38		M	10/17/2000	Arm area had reaction that itched and stomach became very upset.									Y	10/16/2000	10/16/2000	0	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Injection site reaction; Pruritus; Stomach discomfort	FLU3~MEDEVA PHARMA, LTD.~80929~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161561	11/07/2000	WA	47.0	47		F	10/17/2000	One hour, post vax, I began to itch over the site. By the next Saturday morning, I had hives over the area. On Sunday morning, I had nausea and emesis that began with a headache and has continued up to now. Diarrhea began on Monday afternoon.									Y	10/13/2000	10/13/2000	0	NONE	MIL	MIL	Celebrex, trazodone, Prozac	NONE	Allergies to hay and cedar; Osteoarthritis; Fibromyalgia			1						1	Diarrhoea; Headache; Injection site reaction; Nausea; Pruritus; Urticaria; Vomiting	FLU3~MEDEVA PHARMA, LTD.~80929~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161562	11/07/2000	WA	34.0	34		M	10/30/2000	Arm swelled at injection site, turned red and was sore for 1 to 2 days, post vax.									Y	10/13/2000	10/15/2000	2		MIL	MIL	NONE	NONE	NONE			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~MEDEVA PHARMA, LTD.~80929~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161564	11/07/2000	PA	68.0	68		F	10/30/2000	Itchy hives and swelling of the body, especially of the hands. Taking Zyrtec, lasted 5 days.									Y	10/24/2000	10/25/2000	1		UNK	UNK						1						1	Pruritus; Swelling; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0161565	11/07/2000	WY	47.0	47		M	10/30/2000	I had severe muscle pain and joint pains. Worst muscle pain was in shoulders and worst joint pain was in right ankle and right hip joint. No swelling. I have chills and low-grade fever. Symptoms started about 1-2 hours after injection and peaked about 12-15 hours later. Some mild pain persisted for 72 hours. Self treated with prednisone X 2 days.									U	10/27/2000	10/27/2000	0	NONE	PVT	PVT	Flomax, Aciphex	NONE	History of thimansol allergy from contact lens solutions.	Shoulder to the bone~Influenza (Seasonal) (no brand name)~1~35.00~In Patient		1						1	Arthralgia; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~WY4008171~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0161568	11/07/2000	NY	46.0	46		F	11/01/2000	At 20:00, pt had nausea, followed by pain in left cheek radiating to left temple and down to jaw. A feeling of paralysis or numbness, lasting 2-3 hours, then disappearing.									Y	10/27/2000	10/27/2000	0	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Headache; Hypoaesthesia; Nausea; Pain in jaw	FLU3~MEDEVA PHARMA, LTD.~E590906A~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161595	11/08/2000	TX	50.0	50		F	10/27/2000	Within 10 minutes post vax, the pt felt nose swelling inside and tightness of chest. Pt felt bad all day. On the 6th, the pt awoke with diarrhea and aching, arm still red, painful, and swollen. Went back to physician. He prescribed Cefadroxil in case it was an infection. Pt continued with diarrhea and his stomach pain became excruciating. The pt stopped eating and pushing fluids. Went to ER and put on IV fluids. Physician felt the pt was experiencing a toxic reaction. Prescribed Flagyl for antibiotic reaction. Stayed on clear liquids. He kept feeling worse, weak, faint, and confused. Physician sent him to ER again where they admitted him to the hospital. He was put on IV and liquid diet, meds, and soft diet. Pt still not feeling well.  Diagnosed with irritable bowel syndrome.				Y	Y	5			N	10/05/2000	10/05/2000	0	blood tests-nml, x-ray of abdomen	PVT	UNK	Synthroid, natural herbs for menopausal symptoms, initial dose of Pravachol just prior to vaccination.	None	irritable bowel syndrome			1						1	Abdominal pain; Asthenia; Chest discomfort; Confusional state; Diarrhoea; Erythema; Hypersensitivity; Pain; Swelling; Syncope	FLU3~MEDEVA PHARMA, LTD.~5461874~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~468149~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0161609	11/08/2000	TX	47.0	47		F	11/02/2000	Post vax, the pt developed severe pain, swelling, red streaks across arm; sore under arm.									Y	11/01/2000	11/01/2000	0	NONE	PUB	UNK		NONE	allergies			1						1	Erythema; Pain; Swelling	FLU3~AVENTIS PASTEUR~U0402AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~469133~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0161614	11/08/2000	UT	53.0	53		F	10/31/2000	About 1 1/2 hours, post vax, pt began having hives/itchy rash, mild shortness of breath and cough for about 4 hours. Prior flu injection yearly without problems.									U	10/26/2000	10/26/2000	0	Spirometry consistent with prior lower baseline values for pt; no significant changes after albuterol neb.	UNK	UNK	Nasarel, Flovent, Serevent, albuterol, pyrantel, Fe++, Theo-Dur, guaifenesin		Asthma, mild and persistent; seasonal Allergic Rhinitis; Drug allergies: sulfa			1						1	Cough; Dyspnoea; Pruritus; Urticaria	FLU3~AVENTIS PASTEUR~U0337AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161619	11/08/2000	ME	40.0	40		F	10/31/2000	Large hive; 3 area where flu shot was given, along with swollen area on arm and where needle went in looked like a bee bite. Also, had hives on my face and  on my chest. After 4 days, swelling went down and hives were gone. I used Cortaid on hives and took Benadryl. Could have been caused by latex glove the nurse wore; not sure.									Y	10/20/2000	10/21/2000	1	NONE	PVT	UNK	Claritin, Rhinocort, guaifenesin w/peprec	NONE	Seasonal/year round allergies			1						1	Hypersensitivity; Injection site swelling; Urticaria	FLU3~AVENTIS PASTEUR~U0335AB~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161628	11/08/2000	NC	21.0	21		F	11/01/2000	Generalized itching especially palms and scalp. Few urticarial lesions. Received influenza and meningococcal vaccine 10/18/00. No difficulty breathing. Treated with Claritin 10mg at 12:30PM and to take Zyrtec after HS for itching. Developed serum sickness 10/23/00. Treated by doctor with Prednisone, Zyrtec, Singular, Prevacol, and Benadrul				Y						10/18/2000	10/18/2000	0	Chest x-ray 10/23/02 normal	OTH	PVT	NONE	NONE	Allergy to Sulfa/Codeine; Asthma HX; Surgery to repair lacerated pancreas; Car accident			1						1	Pruritus; Serum sickness; Skin ulcer; Urticaria	FLU3~SANOFI PASTEUR~U0399AB~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~SANOFI PASTEUR~718AA~UNK~~RA~MENINGOCOCCAL (MENOMUNE)~1	USA	Emergency room visit	Influenza
0161629	11/08/2000	CA	41.0	41		F	10/17/2000	Joint aches, persistent headache, onset Saturday. Sunday morning symptoms improved. Midday Sunday had aches, fever to 100F, chills, joint and lower extremity. Local reaction Sunday night with swollen, red upper arm. Advil relieved aches. Monday morning had increased redness, swelling and pain locally. Joints improved.									Y	10/13/2000	10/14/2000	1	NONE	OTH	UNK	10/12/00-Injection Cortisone/RA/4 previously	NONE	Fibromyalgia, Allergy Voltaren and PCN			1						1	Arthralgia; Headache; Injection site erythema; Injection site pain; Injection site swelling; Pyrexia	FLU3~AVENTIS PASTEUR~V0398AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~465911~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0161630	11/08/2000	PA	53.0	53		F	10/31/2000	Employee received flu shot on 10/26/00 and developed chest tightness and slight hoarseness immediately after the injection. Seen in ER with complete resolution of the symptoms and discharged.				Y					Y	10/26/2000	10/26/2000	0	EKG-nml; Pulse OX 98% on room air; chest clear	PVT	OTH	UNK	NONE	Hay, some clothes, dust and grass allergies.			1						1	Chest discomfort; Dysphonia	FLU3~AVENTIS PASTEUR~U0346AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0161636	11/08/2000	NC	67.0	67		F	11/02/2000	2 hour bout of atrial fibrillation which began at 22:00. At 22:30, I took additional 1/2 tablet of Rythmol (150mg) and at 23:00, took my usual dosage. Symptoms did not subside until 24:00.									Y	10/23/2000	10/23/2000	0		PUB	UNK	Aspirin, Rythmol, Zocor,Metatroprolol		Atrial fibrillation			1						1	Atrial fibrillation	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0161637	11/08/2000	IL	11.0	11		F	10/31/2000	Fever 104F, back ache, vomiting, diarrhea and pain when walking.				Y					Y	10/27/2000	10/28/2000	1		PVT	PVT			Idiopathic thrombocytopenic purpura with splenectomy			1						1	Back pain; Diarrhoea; Difficulty in walking; Hypokinesia; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~4008171~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0045J~2~IM~LL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0161639	11/08/2000	CA	31.0	31		F	11/02/2000	Within 30 minutes, post vax, she felt sleepy, left arm pain and sweaty. On 11/2/00, temperature was 99.2F, injection still warm with induration, reddened, site sore, arm sore and still tired and sweats.									N	10/31/2000	10/31/2000	0	NONE	PVT	PVT	Advil	NONE	NONE			1						1	Fatigue; Hyperhidrosis; Injection site induration; Injection site pain; Injection site warmth; Pyrexia; Somnolence	FLU3~AVENTIS PASTEUR~U0405AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161641	11/08/2000	CA	39.0	39		F	11/01/2000	Patient states she received the flu vaccine on 10/25/00 between 18:00 and 20:00. She states the next evening, she was itching and her mother noticed she had hives on her neck, back, chest, abdomen, arms and legs. She states her face was clear. She didn't seek medical evaluation but took Benadryl, used calamine cream and took oatmeal bathes. No shortness of breath. She states symptoms all gone by 10/30/00. She states she had the vaccine for the past 8 years without problems.									Y	10/25/2000	10/26/2000	1	NONE	PVT	PVT	Synthroid, Capoten, Alupent	NONE	Allergy to steroids; HTN; Asthma and Hypothyroidism			1						1	Pruritus; Urticaria	FLU3~AVENTIS PASTEUR~U0398AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161643	11/08/2000	IA	70.0	70		F	10/27/2000	Arm began quite swollen and bright red from arm pit to elbow and extending almost all around upper arm. Saw MD the afternoon of 10/25/00. Received 2 injections and cephalexin X 9 days and Levaquin X 1 dose given.				Y					Y	10/24/2000	10/25/2000	1		PUB	PVT		NONE				1						1	Injection site erythema; Injection site swelling	FLU3~AVENTIS PASTEUR~U0408EA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0690K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0161644	11/08/2000	TN	45.0	45		F	11/02/2000	1 to 1 1/2 diameter slightly erythematous macule around injection site. Area is slightly pruritic and warm to touch. Pt noted reaction about 16 hours, post vax.									Y	10/31/2000	11/01/2000	1		PUB	PUB	Ultram 50mg		Allergy to Macrodantin	Erythematous macule atound injection site, slightly pruritic and warm to touch~Influenza (Seasonal) (no brand name)~~40.00~In Pa		1						1	Injection site erythema; Injection site warmth; Pruritus; Rash macular; Vaccine positive rechallenge	FLU3~MEDEVA PHARMA, LTD.~E67950KA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161648	11/08/2000	CA	39.0			F	11/01/2000	Several hours, post vax, pt felt tired and soreness at injection site. She became progressively more tired that evening. Awoke the next morning with soreness at the injection site and aching in arms and legs. Temperature was 101F. She self-administered Tylenol and fever subsided. The following day, she felt weak and tired, but was alright on the 3rd day.									Y	10/16/2000	10/16/2000	0	NONE	OTH	PVT		NONE	NONE			1						1	Fatigue; Injection site pain; Pain; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E68800KA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161724	11/09/2000	ND	48.0	48		F	11/07/2000	11/4/00 at 15:00, temperature was 103.4F, trembling and was given Tylenol. Had increased cough, rhinitis, labored respirations for 25 minutes, cyanosis of nails, temperature 105F. O2 4/L per NC; increased to 6/L per NC. Temperature 106F. Ambulance here and transferred to hospital for the night. At 18:00, admitted to hospital. Temperature has remained down. On 11/5/00, returned home from hospital with orders to resume all previous meds, diet and activity. According to progress notes-no papers have arrived from hospital yet.				Y	Y				Y	11/03/2000	11/04/2000	1	Chest X-ray-neg; lab results-neg; UA on 11/6/00 is within normal limits per doctor.	OTH	PUB	Celebrex, Lactaid, Calcium Oyster Shell, Zyprexa, furosimide, Prilosec, potassium chloride	NONE	Allergy to chocolate, sensitivity to milk and milk products (lactose intolerance), mental retardation, moderate schizophrenic reactions disorder			1						1	Cough; Cyanosis; Dyspnoea; Pyrexia; Rhinitis; Tremor	FLU3~AVENTIS PASTEUR~U0333AB~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0161734	11/09/2000	WA	44.0	44		F	11/01/2000	Within hours, post vax, I had sore throat. During the next day, I came down with severe bronchial infection. Excessive coughing for 1-2 weeks, wheezing, lots of mucus, fever and questionable flu.									Y	10/17/2000	10/17/2000	0		OTH	PVT		NONE	NONE			1						1	Bronchitis; Cough; Influenza; Nasal congestion; Pharyngolaryngeal pain; Pyrexia; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0161735	11/09/2000	GA	67.0	67		F	11/03/2000	Arm got red, hurt and red rash on my arms, hands and legs, had aching, chills, hoarse, cough and was swollen around my vocal cord.									Y	10/11/2000	10/12/2000	1		PUB	UNK	Hydrea, Zoloft		Allergic rhinitis; physician dx'd allergy and reaction to flu shot			1						1	Chills; Cough; Dysphonia; Injection site erythema; Injection site pain; Laryngeal oedema; Pain; Rash	FLU3~MEDEVA PHARMA, LTD.~E65600HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161740	11/09/2000	OH	71.0	71		M	11/07/2000	Generalized rash and itching on 10/12/00. Assessed by physician.				Y					U	10/10/2000	10/12/2000	2		PVT	PVT	Lipitor, Lanoxin, Zestril, Hytrin, ASA, Claritin, Coreg	NONE	HTN, Hyperlipidemia, heart disease (LBBB), allergy to PCN			1						1	Hypersensitivity; Pruritus; Rash	FLU3~AVENTIS PASTEUR~U0399BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0161743	11/09/2000	TN	73.0	73		M	10/26/2000	About 15 minutes, post vax, the pt returned to nursing and reports that he was having a bad taste in his mouth, no other symptoms. Spoke with doctor who advised us to tell pt to wait an additional 15 minutes. Later, pt's friend came back to say it has been 15 minutes and he is fine and can they leave. Then pt got up and was staggering and almost fell and was assisted back to his seat by his friend and another person in the lobby. Nursing was called to the lobby and pt was taken to Life Support. Pt cold and clammy, color pale, BP 177/79, HR-80. Another MD saw pt and he described the bad taste in his mouth as a metal taste and got swimmy headed. The MD exam revealed chest was clear, cardiovascular-RRR without murmurs; abdomen and midline superior abdomen had hernia. Pt reports that he feels better and was released to home.									Y	10/25/2000	10/25/2000	0	EKG-without change; BP after 3 minutes-189/84; BP after 10 minutes-140/92.	MIL	MIL						1						1	Cold sweat; Dizziness; Dysgeusia; Gait disturbance; Hernia; Hypertension; Pallor	FLU3~MEDEVA PHARMA, LTD.~E59270CA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161744	11/09/2000	MI	45.0			F	11/07/2000	Pt has not felt well since receiving the flu vaccine on Thursday. Starting vomiting on Sunday.									U	11/02/2000	11/02/2000	0		UNK	UNK	Insulin		IDDM, bypass X 2, neuropathy			1						1	Feeling abnormal; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0161746	11/09/2000	TN	58.0	58		M	10/26/2000	Pt was with another pt her to get flu shots. His friend complained of bad taste in mouth metal taste and was triaged out assessed. 30 minutes later, pt complained of numbness and tingling at the end of his tongue and mouth. Pt waited 15 minutes and symptoms resolved.									Y	10/26/2000	10/26/2000	0	NONE	MIL	MIL	See below		Takes allergy shots			1						1	Dysgeusia; Hypoaesthesia oral	FLU3~MEDEVA PHARMA, LTD.~E59270CA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161750	11/09/2000	OR	43.0	43		F	11/03/2000	Palms of hand and feet very itchy with small welts on arm. Back of neck itchy. General overall body itchy and creepy/crawly for 2 1/2 days. Took Benadryl.									Y	10/17/2000	10/17/2000	0		PUB	PUB	Zyrtec, Aleve, multivitamins, women's premenapause	NONE	Multiple allergies			1						1	Pruritus; Urticaria	FLU3~AVENTIS PASTEUR~U0399AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161752	11/09/2000	MN	54.0	53		M	11/03/2000	Rash on arms and legs, 1 day, post vax. Benadryl given.									U	11/01/2000	11/02/2000	1		OTH	PVT	Lipitor, Norvasc, folic acid, ASA, vitamins		MI in 3/9/94; sulfa, ??			1						1	Rash	FLU3~PFIZER\WYETH~4008171~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0161765	11/10/2000	NY	74.0	74		M	11/08/2000	Spontaneous report received, 10/30/00, from the son of a pt who experienced an adverse event possibly coincidental with receipt of Fluvirin. Additional information was obtained in a phone call to son on 10/31/00. This 74 year old male received his vaccination on 10/11/00. On 10/12/00, he was noted to be unable to raise his left arm. His PCP referred him to an orthopedic physician, who dx'd atrophy of the shoulder and neck. Pt has been referred to a neurologist; appointment has not yet been confirmed.								Y	N	10/11/2000	10/12/2000	1	MRI-without findings	PVT	OTH	Prozac, Flomax, isoxsuprine		History of prostate problems, balance problems with falling and weak ankles.		MPI2000048650	1						1	Hypokinesia; Muscle atrophy	FLU3~MEDEVA PHARMA, LTD.~E64710HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0161766	11/10/2000	IL	72.0	72		F		Post vax, the pt has experienced lack of normal eye movements in her left eye and a staring right eye. It was also reported that the pt has experienced drooping of both eyelids. The pt has been evaluated by a physician and is receiving treatment with eye drops of unknown name or dosage. Attempts have been initiated to obtain further information.								Y	N	10/12/2000	10/12/2000	0		PUB	OTH	NONE		NONE		MPI2000048370	1						1	Eye disorder; Eyelid ptosis	FLU3~MEDEVA PHARMA, LTD.~E62700HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0161778	11/10/2000	NE	43.0	43		F	11/08/2000	On 11/1/00, post vax, pt had immediate arm discomfort and it continued all day. Approx. 14 hours later, had muscle and joint aches then through the night had an increased in aches and chills, which continued much of next day. She took ibuprofen and antihistamines. The following morning, she woke up with hives on neck and she continued to take Benadryl and ibuprofen and reported to Employee Health on 11/6/00.									Y	11/01/2000	11/01/2000	0	NONE	PUB	UNK	Tamoxifen, Plaquenil	NONE	Erythromycin and Cipro allergies; history of breast cancer and undefined connective tissue disorder			1						1	Arthralgia; Chills; Injection site pain; Myalgia; Urticaria	FLU3~AVENTIS PASTEUR~U0416CA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163237	11/10/2000	NY	45.0			M	10/30/2000	Subsequent to receiving vax, the pt developed a splitting headache and an injection site reaction characterized by swelling, redness, hardness and warmth. Later he developed malaise which lasted about 1 week followed by mild flu symptoms.									Y				UNK	OTH	OTH	Acetylsalicylic acid; Lansoprazole; Metformin; St John's Wort	UNK	diabetes mellitus NOS		HQ1250720SEP2000	1						1	Headache; Influenza like illness; Injection site erythema; Injection site induration; Injection site oedema; Injection site reaction; Injection site warmth; Malaise	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0161789	11/13/2000	OK	93.0	93		F	11/10/2000	On 11/9/00 at 00:15, dyspnea, color blue, R-40, T-99 (ax), BP 176/54, P-68, and expiratory wheezes throughout. O2 started on 2L/NC, SpO2 67% without O2. Tylenol given at 05:30. Pt restless. At 09:20 SpO2 88% without O2 on 4L. Resp 36 and moist rales. Transferred to medical center per ambulance. Of the 21 individuals receiving immunizations, Friday 11/3/00, only 2 on prednisone and had sudden respiratory distress on 11/9/00, 6 days, post vax.  Diagnosed with pneumonia			Y		Y				U	11/03/2000	11/09/2000	6		OTH	PUB	Synthroid, Paxil, vitamin C, Zyrtec, prednisone, cyanocobalamin, Tylenol, Robitussin syrup, hydroxyzine	NONE	CVA, Cardiac Pacemaker in situ 1997, Hypothyroidism, depression, atrial fibrillation, GERD, UTI, senile dementia			1						1	Cyanosis; Dyspnoea; Hyperventilation; Hypotension; Pneumonia; Rales; Restlessness; Wheezing	FLU3~PFIZER\WYETH~4008173~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0161790	11/13/2000	OK	94.0	94		M	11/10/2000	On 11/8/00 at 02:00, pt moaning with abdominal pain. On 11/9/00 at 01:00, pt moaning with increased temperature to 99 (ax), wheezing, restless and at 03:30 started coughing. SpO2 90%. Given Tylenol and Robitussin. At 21:40, pt moaning, wheezing in lower lobes. V/S 76/41, 114, 48, 97.4F (ax); SpO2 78%. Transferred by ambulance to hospital. Of the 21 individuals receiving immunizations 11/3/00, there were only 2 on prednisone that had sudden respiratory distress on the 6th day, post vax.  Follow up received on 4/24/01 states the pt passed away on 2/7/01. Cause of Death - pneumonia.	Y	02/07/2001	Y		Y				N	11/03/2000	11/08/2000	5		OTH	PUB	nitrofurantoin, Zantac, Ditropan, ibuprofen, Tylenol PM, cyanocobalamin (vit-B), Paxil, furosemide, prednisone	NONE	Senile dementia, UTI, dermatitis, depression, stomach function disease, pernicious anemia, neurogenic bladder, insomnia, pemphigoid			1						1	Abdominal pain; Cough; Pneumonia; Pyrexia; Respiratory distress; Restlessness; Wheezing	FLU3~PFIZER\WYETH~4008173~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0161794	11/13/2000	GA	83.0	83		F	10/27/2000	Client was given flu vaccine after signing permission slip and stating she read information sheet. The computer record was incorrectly read for a current flu record indicated a flu shot being given on 10/11/00 at another facility. Pt actually wanted a Pneumonia shot after further assessment was done. Her doctor was notified of the incident on 10/27/00 at 11:45.									U	10/27/2000	10/27/2000	0		PVT	UNK						1						1	Unevaluable event	FLU3~MEDEVA PHARMA, LTD.~E65600HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161795	11/13/2000	DC	71.0	71		F	11/09/2000	Pt was clammy with dizziness, shortness of breath, weakness, nausea and dyspnea. Pt ended up in the ER. The flu shot was given at another facility (not through our office).				Y					Y	10/31/2000	10/31/2000	0	All lab tests-neg	OTH	OTH	Tambocor	NONE	Arrhythmia			1						1	Asthenia; Cold sweat; Dizziness; Dyspnoea; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0161796	11/13/2000	KS	50.0	50		F	11/09/2000	Erythema, swelling and pain in joints of hands, elbows and knees. Rash on legs; erythematous urticaria. ER dx: serum sickness with adverse reaction to the vaccine. Good relief with Solu-Medrol IV followed by prednisone taper and Atarax.				Y					Y	10/31/2000	11/02/2000	2	Sed Rate-elevated at 41; CBC with differential-nml; Renal functions-nml; UA-neg; Chem 7-Potassium-5.3 and Glucose 187	PVT	PVT	Baycol, Zestoretic	NONE	Diabetes Type II-diet controlled; HTN; high cholesterol; allergic to amoxicillin.	Injection site inflammation~Tetanus Toxoid (no brand name)~~25.00~In Patient		1						1	Arthralgia; Blood glucose increased; Hyperkalaemia; Injection site erythema; Injection site swelling; Red blood cell sedimentation rate increased; Urticaria	FLU3~AVENTIS PASTEUR~U0405AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0125809	11/14/2000	CA	0.2	0	.2	M	01/14/2000	22 days post vax, the pt developed irritability, excessive crying and decreased appetite. The pt was seen by a physician in an urgent care center two days later for persistent crying possibly due to abdominal pain. CBC, blood chemistry and urinalysis were performed. Results were not provided. The pt was seen on 05/24, 25, and 26 by the vaccine provider who determined that the pt had an elevated erythrocyte sedimentation rate. The pt recovered after approximately one week. The most recent information received, reports the condition of the pt is resolved.				Y					Y	04/28/1999	05/20/1999	22	05/24/1999 ESR = 0	PVT	OTH					20000010801	1						3	Abdominal pain; Agitation; Red blood cell sedimentation rate increased; Abdominal pain; Agitation; Red blood cell sedimentation rate increased; Abdominal pain; Decreased appetite; Irritability; Red blood cell sedimentation rate increased	DTP~UNKNOWN MANUFACTURER~~UNK~~~DTP (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|HIBV~PFIZER\WYETH~~UNK~~~HIB (HIBTITER)~1|IPV~CONNAUGHT LTD.~~UNK~~~POLIO VIRUS, INACT. (POLIOVAX)~1|RV~PFIZER\WYETH~~1~PO~MO~ROTAVIRUS (ROTASHIELD)~1|DTP~UNKNOWN MANUFACTURER~~UNK~~~DTP (NO BRAND NAME)~2|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~2|HIBV~PFIZER\WYETH~~UNK~~~HIB (HIBTITER)~2|IPV~CONNAUGHT LTD.~~UNK~~~POLIO VIRUS, INACT. (POLIOVAX)~2|RV~PFIZER\WYETH~~1~PO~MO~ROTAVIRUS (ROTASHIELD)~2|DTAP~CONNAUGHT LABORATORIES~7389AA~1~IM~LL~DTAP (TRIPEDIA)~3|FLU3~PFIZER\WYETH~~1~PO~MO~INFLUENZA (SEASONAL) (FLUSHIELD)~3|HEP~SMITHKLINE BEECHAM~2931A2~2~IM~RL~HEP B (ENGERIX-B)~3|HIBV~CONNAUGHT LABORATORIES~N07022A~1~IM~LL~HIB (ACTHIB)~3|IPV~CONNAUGHT LTD.~P0167~1~SC~RL~POLIO VIRUS, INACT. (POLIOVAX)~3	USA	Emergency room visit	Influenza
0155091	11/14/2000	CA	0.08	0	.1	M	01/12/2000	Within two days post vax, the infant developed vomiting and prolonged diarrhea. Stool culture was negative and stool specimen was negative for ova and parasites. The most recent information received reports the condition of the pt is resolved.									Y	05/27/1999	05/29/1999	2	Stool culture - negative; Stool specimen - negative for ova and parasites	PVT	OTH					20000008061	1						2	Diarrhoea; Gastroenteritis; Vomiting; Diarrhoea; Vomiting; Diarrhoea; Vomiting	DTAP~CONNAUGHT LABORATORIES~~1~IM~~DTAP (TRIPEDIA)~1|HEP~SMITHKLINE BEECHAM~~2~IM~~HEP B (ENGERIX-B)~1|HIBV~MERCK & CO. INC.~1204B~1~IM~~HIB (PEDVAXHIB)~1|IPV~PASTEUR MERIEUX INST.~~1~SC~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|RV~PFIZER\WYETH~~1~PO~MO~ROTAVIRUS (ROTASHIELD)~1|DTAP~CONNAUGHT LABORATORIES~6F81445~1~IM~~DTAP (TRIPEDIA)~2|FLU3~PFIZER\WYETH~4988139~1~PO~MO~INFLUENZA (SEASONAL) (FLUSHIELD)~2|HEP~SMITHKLINE BEECHAM~2919A2~2~IM~~HEP B (ENGERIX-B)~2|HIBV~MERCK & CO. INC.~1204E~1~IM~~HIB (PEDVAXHIB)~2|IPV~CONNAUGHT LTD.~M0212~1~SC~~POLIO VIRUS, INACT. (POLIOVAX)~2|DTAP~PFIZER\WYETH~~UNK~IM~~DTAP (ACEL-IMUNE)~3|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~3|HIBV~PFIZER\WYETH~~UNK~IM~~HIB (HIBTITER)~3|IPV~PFIZER\WYETH~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~3|RV~PFIZER\WYETH~~1~PO~MO~ROTAVIRUS (ROTASHIELD)~3	USA		Influenza
0155322	11/14/2000	IL	0.2	0	.2	M	01/12/2000	Three days post vax the pt developed irritability, decreased oral intake, and recurrent episodes of fever every four hours. His temperature went as high as 102 degrees F. Chest x-ray, CBC and blood and urine cultures were normal. The infant recovered within two days. The most recent information received reports the condition of the pt is resolved.									Y	06/04/1999	06/07/1999	3		PVT	PVT				~DTP (no brand name)~~0.00~In Sibling	20000007951	1						2	Pyrexia; Irritability; Pyrexia	DTAP~PFIZER\WYETH~~1~IM~~DTAP (ACEL-IMUNE)~1|HEP~UNKNOWN MANUFACTURER~~1~IM~~HEP B (NO BRAND NAME)~1|HIBV~PFIZER\WYETH~~1~IM~~HIB (HIBTITER)~1|IPV~PASTEUR MERIEUX INST.~~1~SC~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|RV~PFIZER\WYETH~4988131~1~PO~MO~ROTAVIRUS (ROTASHIELD)~1|DTAP~PFIZER\WYETH~462312~1~IM~LL~DTAP (ACEL-IMUNE)~2|FLU3~PFIZER\WYETH~4988131~1~PO~MO~INFLUENZA (SEASONAL) (FLUSHIELD)~2|HEP~SMITHKLINE BEECHAM~ENG2909A2~2~IM~RL~HEP B (ENGERIX-B)~2|HIBV~PFIZER\WYETH~412353A~1~IM~LL~HIB (HIBTITER)~2|IPV~CONNAUGHT LTD.~P0040~1~SC~RL~POLIO VIRUS, INACT. (POLIOVAX)~2	USA		Influenza
0161824	11/14/2000	MO	64.0	64		F	11/02/2000	Post vax, the pt developed aseptic meningitis, fever, headaches, and a stiff neck.			Y	Y	Y				Y	10/11/2000	10/11/2000	0		PVT	OTH		Sciatic nerve problems		Aseptic meningitis, fever, headache, stiff neck~Influenza (Seasonal) (no brand name)~~40.00~In Patient	MO2000082	1						1	Headache; Meningitis; Musculoskeletal stiffness; Pyrexia	FLU3~AVENTIS PASTEUR~U0400AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0161829	11/14/2000	CT	49.0	49		M		Same day post vax, the pt experienced fever, chills, and a rash that was all over his body. The pt was bedridden for five days. It was also reported that the pt was seen by a dermatologist and was treated with Prednisone. No other information was available.									N	10/27/2000	10/27/2000	0		OTH	OTH	NONE		NONE		MPI2000048810	1						1	Pyrexia; Rash	FLU3~MEDEVA PHARMA, LTD.~H66340HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161830	11/14/2000	FL	54.0	54		F	11/07/2000	The pt was hospitalized on 10/27/00 for severe pancreatitis. As of 11/2/00, hospitalization continued. The pt was treated with supportive care. This pt has previously received an influenza vaccine without adverse reaction.					Y				N	10/25/2000	10/27/2000	2	NONE	PVT	OTH	Flonase, Allegra, Verapamil SR, Albuterol, Flovent, insulin, Lipitor		asthma, allergy, diabetes, hypertension, lipids elevated		MPI2000048830	1						1	Pancreatitis	FLU3~MEDEVA PHARMA, LTD.~E59240GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0161883	11/14/2000	IL	36.0	36		F	11/01/2000	Severe local reaction with redness, swelling and warmth of left lateral arm. No treatment needed and in 3 days it resolved completely.				Y					Y	10/19/2000	10/20/2000	1	NONE	PVT	PVT	Theo-Dur, Prinivil, Azmacort, Intal, Zithromax	Sinusitis	NONE			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~AVENTIS PASTEUR~U0336BA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0690K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0161884	11/14/2000	IL	23.0	23		F	11/01/2000	Small area of redness at right shoulder injection site. Tenderness at right upper arm and shoulder. Treated with Benadryl and analgesics. He was lost to further follow-up; unable to be contacted.				Y					U	10/19/2000			NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site pain	FLU3~AVENTIS PASTEUR~U0336BA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0690K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0161886	11/14/2000	NE	70.0	69		F	11/06/2000	Sore throat, fever, vomiting and diarrhea (continuous for 8 hours). In hospital had IV's and IV antibiotic (I had taken charcoal prior to hospital stay). 7 hour hospital stay.				Y					Y	10/28/1999	10/28/1999	0	UNK	PVT	PVT	Dralestin, Indocin, Demerol, Novahistine, Darvon, erythromycin, Talwin, Darvoset	NONE				1						1	Diarrhoea; Pharyngolaryngeal pain; Pyrexia; Vomiting	FLU3~CONNAUGHT LABORATORIES~U0159AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0161890	11/14/2000	MI	48.0	48		F	11/06/2000	Local swelling, pain and redness about a 6 diameter, lasted over 3 days. Not responding to to ice, finally better with po prednisone.				Y					Y	11/01/2000	11/01/2000	0	NONE	PVT	PVT	NONE	NONE	NONE	Swollen arm~Td Adsorbed (no brand name)~~28.00~In Patient		1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~PFIZER\WYETH~4008172~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0161891	11/14/2000	DE	48.0	48		F	11/03/2000	Symptoms began on 11/2/00, after awakening in the morning with a temperature of 103F, vomiting X 4, headache and chills. Temperature was 99F-101F on 11/3/00 with 14cm X 16cm diameter indurated right area of left deltoid with redness to inner arm and tender to touch.									U	11/01/2000	11/02/2000	1		PVT	PVT		NONE	DM, Asthma			1						1	Headache; Injection site erythema; Injection site induration; Injection site pain; Pyrexia; Vomiting	FLU3~MEDEVA PHARMA, LTD.~64320HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0544K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0161893	11/14/2000	IL	70.0	70		F	11/03/2000	Hives and welts all over my body for 3 days. Took allergy Benadryl with Tylenol. I've had flu vaccine for the past 7 years and this was my first adverse reaction.									Y	10/20/2000	10/21/2000	1		PUB	UNK	Dyazide, Adalat		Allergic reaction to a bee sting 3 weeks prior to shot. Had to see doctor and get prescription combat itching and swelling.			1						1	Urticaria	FLU3~MEDEVA PHARMA, LTD.~E64330HA~7+~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161894	11/14/2000	NY	21.0	21		F	11/06/2000	Swelling, redness and soreness.									Y	11/03/2000	11/03/2000	0		OTH	PVT	Flovent, Ortho Tri-Cyclen	NONE	PCN			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~MEDEVA PHARMA, LTD.~E59090GA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161897	11/14/2000	IA	48.0	48		F	11/15/2000	Fever, chills, aches, fatigue, muscle weakness, headache X 4 days, dizziness, confused, sweating, nausea, increased blood glucose and pain in shoulder and shoulder blade.									Y	11/13/2000	11/13/2000	0	NONE	PUB	OTH	Insulin, Glucophage (metformin), Synthroid, enalapril, Allegra +	DM, HTN	Allergy to dust, mold, late trees, Hashimoto's Thyroiditis			1						1	Blood glucose increased; Confusional state; Dizziness; Fatigue; Headache; Hyperhidrosis; Muscular weakness; Nausea; Pain; Pyrexia	FLU3~AVENTIS PASTEUR~U0399AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161899	11/14/2000	CO	72.0	72		F	11/03/2000	13 1/2cm X 14 1/2cm raised, inflammed upper left arm about 12 hours, post vax. Temperature of 100.1F. Pt treated site that evening with warm compress.									U	11/02/2000	11/03/2000	1		PUB	PUB			Eye disorder	Inflammed injection site with fever~Td Adsorbed (no brand name)~~72.00~In Patient		1						1	Injection site inflammation; Injection site swelling; Pyrexia	FLU3~AVENTIS PASTEUR~U0415AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0944K~UNK~SC~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0161917	11/14/2000	MT	79.0	79		F	11/02/2000	Erythema, edema and itching below injection site.				Y					Y	10/30/2000	10/30/2000	0	NONE	PVT	PVT	Etrafon, Micro-K, Restoril, Xanax, metoprolol, Synthroid, Maxide	NONE	Arthritis, HTN, hypothyroidism			1						1	Injection site erythema; Injection site oedema; Pruritus	FLU3~AVENTIS PASTEUR~U0402EA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~473554~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0161919	11/14/2000	NJ				F		Had the flu vaccination on 10/27/00 and the next day, began experiencing body aches, low-grade fever, generalized malaise and lower back discomfort. These symptoms continued for 6 days.									Y	10/27/2000	10/28/2000	1	NONE	UNK	UNK	Hypertension medication	NONE	Allergy to PCN			1						1	Back pain; Malaise; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0161922	11/14/2000	AR	46.0	46		F	11/08/2000	2 hours, post vax, left arm throbbing and hurt quite bad. Took Tylenol and it eased. 3 hours later, arm hurting and had a headache, so went to bed. The next day, it was ok.									Y	11/03/2000	11/03/2000	0		PUB	PUB		NONE			AR0047	1						1	Headache; Hypersensitivity; Injection site pain	FLU3~AVENTIS PASTEUR~U0410AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161923	11/14/2000	AR	31.0	31		F	10/31/2000	Severe headache, stomach cramping and chest hurting.									Y	10/31/2000	10/31/2000	0		PUB	UNK		NONE	NONE		AR0045	1						1	Abdominal pain; Chest pain; Headache	FLU3~AVENTIS PASTEUR~U0410AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161924	11/14/2000	AR	64.0	64		M	10/31/2000	Stomach burning, headache, flushed, nausea and dizziness.									Y	10/31/2000				PUB	UNK	aspirin, Zantac, Coreg, vitamin E		Procardia, Phenergan, Demerol, Lidocaine, bretylium		AR0046	1						1	Abdominal discomfort; Dizziness; Flushing; Headache; Nausea	FLU3~AVENTIS PASTEUR~U0410AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161926	11/14/2000	MA	43.0	43		F	11/08/2000	Pt felt feverish, right deltoid/arm ache and had headache 4-6 hours, post vax. Pt was evaluated on 11/4/00 and 11/6/00. On 11/6/00, describes persisting fever and chills and spontaneous draining/bleeding abscess in right perineal/labial area.									Y	11/04/2000	11/04/2000	0	10/12/00, all labs were normal.	PUB	PUB	Nicoderm, Levoxyl, Procardia, Prilosec, Allegra, multivitamins	Resolving URI; ? developing abscess	Allergy to Bactrim; hypothyroidism, HTN, high cholesterol; GERD; RSD (leg)			1						1	Abscess; Headache; Injection site pain; Pyrexia	FLU3~AVENTIS PASTEUR~U0400AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161927	11/14/2000	NY	56.0	56		F	11/06/2000	Received flu vaccine and pneumonia vaccine on 11/3/00 in right deltoid. On 11/6/00, presented with localized redness encircling left arm and light generalized redness of upper body.									Y	11/03/2000	11/04/2000	1		PUB	PUB	Lo-Trol, Premarin, Darvocet, Flexeril	NONE	Sulfa drugs, ibuprofen, iodine, seafood allergies.			1						1	Erythema; Injection site erythema	FLU3~AVENTIS PASTEUR~U0416DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~463748~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0161932	11/14/2000	CA	79.0	78		F	11/06/2000	Right arm swollen, hot and red with shaking chills for 2 weeks.									Y	10/04/2000	10/04/2000	0		PVT	PVT		NONE	NONE			1						1	Chills; Injection site erythema; Injection site swelling; Injection site warmth; Tremor	FLU3~AVENTIS PASTEUR~U0337AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161935	11/14/2000	VA	64.0	64		F	11/09/2000	Pt developed redness, soreness and swelling at the site of the injection, within 24 hours, post vax.				Y					Y	11/07/2000	11/08/2000	1	NONE	PVT	UNK			Sulfa causes a rash; history of GERD and Irritable Bowel Disease.			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~MEDEVA PHARMA, LTD.~E64320HA~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0161936	11/14/2000	FL	49.0	49		F	11/07/2000	Immediately felt pain and burning at site and felt like nerve endings were on edge. Approx. 1 hour later, did not feel well and noticed her cheeks and upper neck were bright red and blotchy. Chest felt tight and had to use accessory muscles to breathe. BP 150/88, HR 109. Treated in ER with Solu-Medrol IV and Pepcid IV and given a prescription for Pepcid po and Medrol dose pack to take when discharged from the ER.				Y					Y	11/04/2000	11/04/2000	0	NONE	PVT	PVT		NONE	Allergy to Tigan, documented in 1976.			1						1	Blood pressure increased; Chest discomfort; Dyspnoea; Feeling abnormal; Heart rate increased; Injection site pain; Neuralgia; Rash macular	FLU3~AVENTIS PASTEUR~U0409AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0161941	11/14/2000	CA	54.0	54		F	11/06/2000	On 11/4/00 at approx. 6 hours, post vax, began to feel achy and no appetite. At 03:00, had chills, fever, body aches, involuntary muscle movement in right hand, shaking and nausea. On 11/5/00, reported sequence of symptoms pt went to ER. Fever, increased BP and pulse and was treated with O2, monitored, fluids, exam.				Y					Y	11/03/2000	11/04/2000	1	CBC, BMP, UA	PVT	PUB	Allegra, Celebrex, Darvocet, Biaxin	Sinus infection	NONE			1						1	Anorexia; Blood pressure increased; Dyskinesia; Heart rate increased; Nausea; Pain; Pyrexia; Tremor	FLU3~MEDEVA PHARMA, LTD.~E67330KA~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0161944	11/14/2000	CA	49.0	49		F	11/09/2000	On 11/6/00, states had nasal/sinus symptoms in the morning. On 11/9/00, noticed a rash on chest.									Y	11/03/2000	11/06/2000	3		PUB	PVT		NONE				1						1	Nasal congestion; Rash	FLU3~AVENTIS PASTEUR~U0406AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163317	11/14/2000	NJ	49.0	49		F	12/22/1999	Subsequent to receiving vax, the pt experienced rash and itching at the injection site. Engerix B was discontinued. The most recent information received reports the condition of the pt is unknown.									N	11/17/1999				OTH	OTH			allergic to codeine, PCN; eczema; possibly allergic to yeast		19990332831	1						1	Injection site hypersensitivity; Pruritus; Rash	FLU3~MEDEVA PHARMA, LTD.~E24249GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~SMITHKLINE BEECHAM~3074A2~1~IM~RA~HEP B (ENGERIX-B)~1	USA		Influenza
0161952	11/15/2000	PA	70.0	70		F	11/06/2000	I was given the flu shot on Monday, 10/30/00. Tuesday night, I was very sick. On Wednesday, I had nausea all day, I got so dizzy, all day, that I couldn't walk. I felt like I was walking sideways. Wednesday night, I had hives. The follow up states, I also beside hive-sick and dizziness had a eyelid twitch lasting 5 weeks. Went to Dr. and he said somethingin that this shot did not like me. He gave me Claritin and Allegra.									Y	10/30/2000	10/31/2000	1	UNK	PUB	OTH		NONE	NONE			1						1	Abasia; Coordination abnormal; Dizziness; Feeling abnormal; Muscle twitching; Nausea; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0161958	11/15/2000	CO	47.0	47		F	11/07/2000	Nausea, sweating, weakness, 10 minutes after injection and lasted approx. 20 minutes. Itching and redness in right hand and anticubital area, sometime, as above, redness subsided by mid-afternoon; itchy sensation and tenderness in right hand continued the day after injection. Right flank pain, approx. 3-4 hours, post vax, and still present the next day, but very mild; no fever, chills or other symptoms.									Y	11/06/2000				PUB	PUB	Estraderm patch	NONE	Allergy to animal dander, Cleocin, Zoloft; menopausal			1						1	Asthenia; Erythema; Hyperhidrosis; Nausea; Pain; Pruritus	FLU3~AVENTIS PASTEUR~U0415AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161959	11/15/2000	CA	48.0	48		F	11/03/2000	Face flushed 10-15 minutes, post vax. Pt then slept about 2 hours and awoke with chills, high temperature and malaise. Has had anorexia and sore throat for 8 days. Seen by MD on 6th day. Improving slowly, day by day.									U	10/27/2000	10/27/2000	0	NONE	OTH	OTH	Cozaar, Prilosec	NONE	Allergies; PPD component, bee stings, spider bites; dx'd with hypertension	Flu-like symptoms~Influenza (Seasonal) (no brand name)~~18.00~In Patient		1						1	Anorexia; Flushing; Malaise; Pharyngolaryngeal pain; Pyrexia; Somnolence	FLU3~MEDEVA PHARMA, LTD.~E67950KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161960	11/15/2000	MN	57.0	57		F	11/09/2000	Large localized swelling and erythema >15cm in diameter on upper arm in vicinity of pneumovax.				Y					U	11/06/2000	11/07/2000	1	NONE	PVT	PVT	Cardizem, Premarin, aspirin, Glucosamine, Advil	NONE	Mitral valve prolapse, tachycardia			1						1	Injection site erythema; Injection site swelling	FLU3~AVENTIS PASTEUR~U0398AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1531J~2~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~U0330AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0161962	11/15/2000	MI	35.0	35		F	11/08/2000	Large red and warm area over deltoid area (4 X 2). Area is painful and very itchy. Mild flu-like symptoms.									Y	10/23/2000	10/23/2000	0		PVT	OTH	BC tablets	NONE	Allergic to dust mites			1						1	Influenza like illness; Injection site erythema; Injection site pain; Injection site warmth; Pruritus	FLU3~AVENTIS PASTEUR~U0400AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161963	11/15/2000	CA				F	11/06/2000	Pt experienced severe sore throat, headache, body aches and high fever the next day, post vax. Symptoms lasted for 3 days.									N	11/03/2000	11/04/2000	1		PUB	PUB	aspirin	NONE	NONE			1						1	Headache; Pain; Pharyngolaryngeal pain; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E67380KA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0161964	11/15/2000	GA	43.0	43		F	11/09/2000	Local skin reaction.									U	11/08/2000	11/08/2000	0		PVT	PVT						1						1	Hypersensitivity	FLU3~AVENTIS PASTEUR~U0416FA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1531J~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0161973	11/15/2000	TN	8.0	8		M	11/06/2000	Pt was given injection at 15:30 on Friday. Saturday at 16:00, injection site was the size of a baseball, red, hot and itching. He was given 2 tsp Benadryl and inflammation was gone the next morning.									Y	10/27/2000	10/28/2000	1	NONE	PVT	OTH	Prilosec, Zantac, Pulmacort,	NONE	Asthma, GERD			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Pruritus	FLU3~AVENTIS PASTEUR~U0415AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161974	11/15/2000	TN	6.0	6		F	11/06/2000	Pt was given injection at 15:30 on Friday. On Saturday at 16:00, injection site was the size of a baseball, red, hot and itching. Was given 1 1/2 tsp Benadryl and inflammation was gone the next morning.									Y	10/27/2000	10/28/2000	1	NONE	PVT	OTH	NONE	NONE	Bilateral ear tubes			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Pruritus	FLU3~AVENTIS PASTEUR~U0415AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161977	11/15/2000	IA	58.0	58		F	11/09/2000	Back of left arm very red and redness going down to her elbow and forearm area. Warm packs to area and take Benadryl.				Y					Y	10/27/2000	10/28/2000	1	NONE	PVT	PVT	Lanoxin, Vasotec, Coumadin, Coreg, Demadex, Vancenase	UTI	CHF, atrial fibrillation, cardiomyopathy			1						1	Injection site erythema	FLU3~AVENTIS PASTEUR~U0410AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0161979	11/15/2000	PA	69.0	69		F	11/10/2000	Red, raised rash over body except face, hands and feet. Doctor saw pt on Thursday, 11/9/00. He stated pt was having a severe drug reaction. He ordered methylprednisolone pack.				Y					U	11/06/2000				PUB	UNK	Levoxyl, Cardizem, Teveten, Premarin, Glucophage, (nurse study-antixidat cardio)		Allergy to erythromycin			1						1	Drug toxicity; Rash erythematous; Rash erythematous	FLU3~MEDEVA PHARMA, LTD.~E59070GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~E59070GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0161982	11/15/2000	MI	45.0			F	11/07/2000	Pt not felt well since flu vaccine on Thursday. Started nausea and vomiting on Sunday. Received vaccine in MD's office.									U	11/02/2000	11/05/2000	3		UNK	UNK	insulin		IDDM, bypass X 2, neuropathy			1						1	Malaise; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0161983	11/15/2000	UT	66.0	66		F	11/07/2000	Left arm became very sore, so painful I could not sleep all night. The next day, 24 hours, post vax, I could not move my arm due to severe pain and stiffness. Went to MD and he gave me a muscle relaxer and hot and cold treatment.				Y					Y	11/02/2000	11/02/2000	0		OTH	OTH	Fosamax, E-Vista	NONE	NONE			1						1	Hypokinesia; Injection site pain; Insomnia; Musculoskeletal stiffness	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0161989	11/15/2000	PA	50.0	50		F	11/07/2000	On 10/25/00, pt reports 50 cents sized red mark on arm from vaccine site with warmth to touch. Pt instructed to use ice to area and call if worsens.									Y	10/23/2000	10/25/2000	2		PVT	OTH	UNK	NONE	NONE			1						1	Injection site erythema; Injection site warmth	FLU3~MEDEVA PHARMA, LTD.~E61750GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0162001	11/15/2000	CA	55.0	55		F	11/06/2000	Post vax, the pt had severe pain in upper left arm. The pt had swelling and erythema of entire upper arm spreading to neck and hand. Neck limited movement, tingling hand. Went to ER and received Ancef, Keflex, and Vicodin.				Y					Y	11/03/2000	11/03/2000	0		PUB	PUB	Bentyl, Metamucil, Cozaar, Prilosec, Fiorinal	hypertension	chronic hepatitis C, GERD, irritable bowel syndrome, chronic anxiety			1						1	Erythema; Oedema peripheral; Pain; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0162002	11/15/2000	IA	56.0	56		M	11/09/2000	Post vax, the pt developed swollen right arm with some redness. Treated with Benadryl.				Y					Y	10/27/2000	10/28/2000	1	NONE	PVT	PVT		NONE	hyperlipidemia			1						1	Erythema; Oedema peripheral	FLU3~AVENTIS PASTEUR~U0410AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~470590~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0162009	11/16/2000	MD	14.0	14		M	11/14/2000	Low-grade and genuine malaise the next day and increasing temperature to 106F with chills. Pt is a kidney transplant pt on cyclosporine and prednisone.					Y	4			Y	10/31/2000	11/01/2000	1		PVT	PUB	Bactrim, nitrofurantoin	NONE	Kidney transplant			1						1	Malaise; Pyrexia	FLU3~AVENTIS PASTEUR~U0406AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0162101	11/17/2000	IA	83.0	83		M	11/13/2000	Pt received flu shot on 10/14/1999, developed severe cough 10/29, was coughing up blood on 10/30. Was hospitalized 10/30 and received transfusion on 10/31. Tests were conducted and he was referred on 11/14. Pt died on 12/23/99.	Y	12/23/1999	Y		Y	11			N	10/14/1999	10/29/1999	15	X-rays, lung scrub, tests (nos).	UNK	UNK	Accupred, Lasix, K-Dur, Prilosec		Hypertension, CHF, hypercholesterolemia,	Cough~Influenza (Seasonal) (no brand name)~~82.00~In Patient		1						1	Cough; Haemoptysis	FLU3~PFIZER\WYETH~4998217~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0162111	11/17/2000	FL	9.0	9		M	11/04/2000	Pt diopheric. C/O difficulty breathing, pt cool to touch. 3 cc Epinephrine. MD seem to think it was not a true reaction it might of been a physcialogical reaction. Pt doing fine.				Y					Y	11/09/2000	11/09/2000	0		OTH	PVT						1						1	Dyspnoea; Feeling cold; Hyperhidrosis	FLU3~AVENTIS PASTEUR~U0421AA~1~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163881	11/17/2000	FL	69.0			F	06/29/2000	The pt developed an injection site reactions characterized by a large area of redness and itching. She recovered.									Y				UNK	OTH	OTH	UNK	UNK	UNK	injection site reactions~Influenza (Seasonal) (FluShield)~3~0.00~In Patient	HQ6778202JUN2000	1						1	Injection site erythema; Pruritus	FLU3~PFIZER\WYETH~~5~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163882	11/17/2000	CA	63.0			F	08/08/2000	The pt immediately experienced a headache. She recovered. The pt reported undergoing a thyroidectomy in 1966 and reported experiencing viral infectious attack on her nervous system in 1984.									Y				UNK	OTH	OTH	UNK	UNK	Thyroidectomy, viral infection	headache~Influenza (Seasonal) (no brand name)~3~0.00~In Patient	HQ8219306JUL2000	1						1	Headache; Similar reaction on previous exposure to drug	FLU3~PFIZER\WYETH~~4~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0162206	11/20/2000	IL	46.0	46		F	11/16/2000	2 hours post vax, the pt felt flushed and achy. Early the following morning, the pt felt numbness which started at the neck, moved up through entire head. Had ringing in ears was slightly confused. 911 was called and the pt was taken to the ER. Pt stated she thought she might of had a stroke.				Y					Y	11/15/2000	11/16/2000	1		PUB	PVT	Verapamil, Accupril, Lasix, Glucophage, Paxil, insulin	NONE	diabetes, back problems, Fibromyalgia, hayfever, allergy			1						1	Confusional state; Flushing; Hypoaesthesia; Pain; Tinnitus	FLU3~AVENTIS PASTEUR~U0410AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162207	11/20/2000	NY	53.0	53		F	11/13/2000	The pt woke up with itchy, reddened eyes and swollen lip. Denied respiratory symptoms. Treated in ER with Benadryl. Discharged.				Y					U	11/09/2000	11/09/2000	0	Temp - 99, Oxygen - 97%, BP - 142/90	PUB	OTH			allergies			1						1	Erythema; Eye disorder; Hypertension; Pruritus; Pyrexia	FLU3~AVENTIS PASTEUR~U0422BA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162208	11/20/2000	CA	34.0	34		F		The pt experienced left upper arm pain with numbness and tingling. The left hand and 4th and 5th digits had numbness and tingling. The symptoms started suddenly 10-15 minutes post vax.				Y					N	11/07/2000	11/07/2000	0		PVT	PVT	NONE	NONE	NONE			1						1	Injection site pain; Paraesthesia	FLU3~AVENTIS PASTEUR~U0405AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162210	11/20/2000	CT	29.0	29		F	11/14/2000	The pt complained of initial swelling at injection site. 45 minutes post vax, the pt experienced swelling of tongue and throat. Pt took Benadryl on own and went to the clinic. Was given Solumedrol (IV).				Y					Y	11/04/2000	11/04/2000	0	NONE	PUB	PVT	NONE	NONE	NONE			1						1	Injection site oedema; Pharyngeal oedema; Tongue oedema	FLU3~MEDEVA PHARMA, LTD.~E59090GA~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0162212	11/20/2000	MA	44.0	44		F	11/09/2000	The pt complained of shortness of breath, difficulty swallowing. While in the ER, the pt experienced partial paralysis of right side mostly the leg and no control of hands, speech, eyes or thinking. By 10/26, symptoms have resolved.				Y					Y	10/19/2000	10/19/2000	0	CAT scan, blood test	PVT	OTH	Paxil, Copaxone	NONE	Multiple Sclerosis			1						1	Dysphagia; Dyspnoea; Hemiplegia; Speech disorder	FLU3~MEDEVA PHARMA, LTD.~E61750GA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0162215	11/20/2000	CT	36.0	36		F	11/17/2000	The pt experienced hives with generalized blotchiness. The pt experienced questionable swelling in right hand.				Y					Y	11/02/2000	11/03/2000	1		PUB	PVT		NONE	allergy to PCN			1						1	Oedema peripheral; Rash macular; Urticaria; Rash macular	FLU3~MEDEVA PHARMA, LTD.~E67940KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~~7+~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0162219	11/20/2000	CA	62.0	62		F	11/08/2000	The pt experienced purple and yellow bruise, swelling 2 in diameter at the injection site. Some edema on chest side over breast and in arm.									U	11/04/2000	11/06/2000	2		PUB	PVT	Prinivil, Detrol, Verapamil, Premarin	NONE	irregular heart beat, high blood pressure			1						1	Ecchymosis; Injection site oedema; Oedema; Skin discolouration	FLU3~AVENTIS PASTEUR~U0409AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162221	11/20/2000	CA	62.0	62		F	11/08/2000	Rash, below vaccine site with some itching.									U	11/04/2000	11/06/2000	2		UNK	PVT	Lipitor, Azulfidine, Zantac		Colitis, high cholesterol			1						1	Injection site reaction; Pruritus; Rash	FLU3~AVENTIS PASTEUR~U0409AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162222	11/20/2000	ME	46.0	46		F	11/11/2000	Approx. 8 hours, post vax, pt noted tachycardia 120-130, restlessness, then itching of palms, feet and both arms to shoulders. Itching subsided with Benadryl. Slept poorly rest of the night.									Y	11/09/2000	11/09/2000	0		PUB	PUB		NONE	Allergic to Flexeril, Droperidol and Erythromycin.			1						1	Pruritus; Restlessness; Sleep disorder; Tachycardia	FLU3~MEDEVA PHARMA, LTD.~E61760GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0162223	11/20/2000	VA	41.0	41		F	11/13/2000	Pt had red, raised rash over entire body with temperature of 100.5F and felt achy all over. Started on Friday night, 11/10/00, post vax, that same afternoon.									Y	11/10/2000	11/10/2000	0		PVT	PVT		NONE	Asthma; Bipolar			1						1	Pain; Pyrexia; Rash erythematous	FLU3~MEDEVA PHARMA, LTD.~E70210KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0162226	11/20/2000	GA	64.0	64		F		The pt states that my arm began to hurt, then it became red. The next day it was worse. I ran a fever of 101.6. I started swelling and itching. It went down to my elbow. It was still red and swollen.									Y	10/02/2000	10/02/2000	0	UNK	PUB	UNK						1						1	Injection site erythema; Injection site oedema; Injection site pain; Pruritus; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0161979	11/21/2000	PA	69.0	69		F	11/13/2000	The pt experienced a raised red rash on chest, neck going, and inner arms, not itchy. No respiratory symptoms. Treated with Prednisone, rash is fading.				Y					U	11/06/2000	11/07/2000	1		PUB	PUB						1						2	Drug toxicity; Rash erythematous; Rash erythematous	FLU3~MEDEVA PHARMA, LTD.~E59070GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~E59070GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0162390	11/21/2000	NY	1.5	1	.6	F	11/08/2000	Post vax, the pt developed a low grade fever and subsequently had a seizure after having a tepid bath.				Y					Y	11/06/2000	11/07/2000	1		PVT	PUB	Pulmocort	right otitis media	asthma			1						1	Convulsion; Pyrexia	FLU3~AVENTIS PASTEUR~U0346AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~473340~1~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0162410	11/21/2000	MD	69.0	69		F	11/14/2000	The pt experienced erythema that was 4cm in diameter with tenderness, warm to the touch, and swelling. Treated with Cipro for possible cellulitis of right arm.				Y					U	11/09/2000	11/10/2000	1		PUB	PUB	Azmacort, ASA, Pericolace, Flonase, Lasix, Lapid		allergy to PCN, diabetes, hypertension, COPD, anxiety, GERD			1						1	Cellulitis; Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLU3~PFIZER\WYETH~4008174~7+~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0162412	11/21/2000	NJ	86.0	86		F	11/08/2000	The pt experienced dizziness for approximately 4 hours. The pt states So dizzy, I nearly fell to the floor 3 times. Pt went to bed and the following morning was ok.									Y	11/01/2000	11/01/2000	0		UNK	UNK	Prinivil					1						1	Dizziness	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0162413	11/21/2000	IL	71.0	71		F	10/18/2000	The pt experienced itching and stinging at the injection site. Then hives and blisters appeared. She stated there are more than a dozen covering her left upper arm. She has had mild reactions to flu shots in the past, but denied this on the consent. Instructed to see MD.				Y					Y	10/01/2000	10/02/2000	1		PUB	PVT		NONE	allergies to various perfumes/beauty products	hive like rash~Influenza (Seasonal) (no brand name)~~0.00~In Patient	IL00055	1						1	Blister; Injection site hypersensitivity; Pain; Pruritus; Similar reaction on previous exposure to drug; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E64300HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0162424	11/21/2000	PA	43.0	43		F	11/13/2000	Increased heart rate, dizziness, weakness, paleness and increase BP. Lasted approx 1 hour. Subsequent MD visit was made with dx of mitral valve prolapse.				Y					Y	10/10/2000	10/10/2000	0	Potassium 3.0	UNK	UNK		NONE				1						1	Asthenia; Blood pressure increased; Dizziness; Heart rate increased; Hypokalaemia; Mitral valve incompetence; Pallor	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0162428	11/21/2000	MA	70.0	70		F	11/14/2000	The pt experienced swelling and complained of pain in the left deltoid. Treated with ice pack.									Y	11/02/2000	11/03/2000	1		OTH	UNK		fracture of the femur - right hip	NONE			1						1	Injection site oedema; Injection site pain	FLU3~AVENTIS PASTEUR~U0345AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~472100~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0162429	11/21/2000	MI	40.0	40		F	11/13/2000	The pt complained of swollen, red, itchy eyelids and itchy throat post vax. Several months prior had same reaction to allergy injection and was determined to be sensitive to some component in the base.				Y					Y	11/09/2000	11/09/2000	0		PVT	PVT	allergy injection	NONE	allergy to base in allergy shot, molds, cats, dogs, milk			1						1	Erythema; Eyelid oedema; Pruritus	FLU3~MEDEVA PHARMA, LTD.~E59930GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0162433	11/21/2000	WI	43.0	43		F	11/09/2000	1 Days following vax, the pt developed hives and flu like symptoms. It was reported to the MD who told the pt the reaction was related to the flu vaccine. The pt had hives with a prior vaccine in 1999.									U	10/25/2000	11/07/2000	13		OTH	UNK				hives~Influenza (Seasonal) (no brand name)~~42.00~In Patient		1						1	Influenza like illness; Similar reaction on previous exposure to drug; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0162438	11/21/2000	KS	59.0	59		M	11/08/2000	The pt experienced diarrhea, huge hive on right size as big as an egg, bright red and swollen.									Y	10/18/2000	10/19/2000	1		PUB	PVT		NONE	allergy to Cipro, chemicals in sunscreen			1						1	Angioneurotic oedema; Diarrhoea; Erythema	FLU3~MEDEVA PHARMA, LTD.~E59240GA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0162439	11/21/2000	TX	37.0	38		F	11/13/2000	One day post vax the pt's arm was noted to be swollen and bruised. By that evening, the pain had spread to armpit, neck and down arm with softball sized bruise and swelling at the site of injection. Treated with Prednisone and antibiotics. Denied any other symptoms.				Y					Y	11/08/2000	11/09/2000	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site haemorrhage; Injection site oedema; Injection site pain; Neck pain; Pain	FLU3~AVENTIS PASTEUR~U0400AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162440	11/21/2000	MI	51.0	51		F	11/02/2000	15 minutes post vax, the pt started experienced sensitivity to the sun, eyes watering, needed to remove contacts, sleepless nights, eyes watering continually, eyelids swollen, right eye almost swollen shut, nose draining clear discharge. Needs to keep shades drawn, eyes still watering continually.				Y					U	11/01/2000	11/01/2000	0		PUB	OTH	NONE	NONE	allergy to Sulfa			1						1	Eyelid oedema; Insomnia; Lacrimation increased; Photophobia; Rhinorrhoea	FLU3~AVENTIS PASTEUR~U0336AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162804	11/21/2000	CT	68.0	68		M	11/21/2000	Nine days, post vax, I developed a severe cold. I had not had a cold for 2 years prior to flu shot.									Y	10/25/2000	11/01/2000	7		PUB	UNK	Vasotec, carbamazepine		Colitis			1						1	Nasopharyngitis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0162463	11/22/2000	PA	54.0	53		F	11/15/2000	On 8/7/00, the pt was admitted to the hospital with congestive heart failure and polymyositis. The pt is still currently in the hospital. Followup information received 3/6/01 reports pt not hospitalized with CHF but with dermatomyonitis, respiratory failure, acute renal failure and other conditions.					Y				N	10/14/1999	08/07/2000	298		PUB	PUB					U2000008190	1						1	Cardiac failure congestive; Dermatomyositis; Polymyositis; Renal failure acute; Respiratory failure	FLU3~CONNAUGHT LABORATORIES~U0131AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0162464	11/22/2000	UT	23.0	23		F	10/30/2000	Cellulitis of left arm at site where received flu shot on 10/30/00; received 3 other shots at 13:30 on 10/30/00 (pneumococcal, Hep-B and Tetanus) arm red, immobile, hot and swollen. Dx: Cellulitis left arm and spreading and kidney infection. I received medical attention until 11/11/00. I got cellulitis from shot. I had to have IV treatments and go to the doctor 3 times a day.				Y	Y	12	Y		Y	10/30/2000	10/30/2000	0		PUB	PUB	NONE	NONE	NONE			1						1	Cellulitis; Injection site erythema; Injection site swelling; Injection site warmth; Kidney infection; Cellulitis; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Kidney infection; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~~PNEUMO (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~IM~~TETANUS TOXOID (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEP~SMITHKLINE BEECHAM~ENG3376A4~1~IM~RA~HEP B (ENGERIX-B)~2|PPV~MERCK & CO. INC.~0044J~1~IM~LA~PNEUMO (PNEUMOVAX)~2|TD~CONNAUGHT LABORATORIES~U0114BA~2~IM~RA~TD ADSORBED (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0162464	11/22/2000	UT	23.0	23		F	11/02/2000	Questionable cellulitis on left upper arm. It is red, swollen, hot and painful. It is immobile. I believe the flu shot that I received gave me cellulitis. I didn't get the lot # or manufacturer #. Also received pneumococcal, Hep-B and Tetanus at 16:30. Had a fever at 18:30. Doctor dx'd cellulitis of left arm and kidney infection. Did not clear up until 11/11/00.				Y	Y		Y		Y	10/30/2000	10/30/2000	0		PUB	PUB		NONE	NONE			1						2	Cellulitis; Injection site erythema; Injection site swelling; Injection site warmth; Kidney infection; Cellulitis; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Kidney infection; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~~HEP B (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~~PNEUMO (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~IM~~TETANUS TOXOID (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEP~SMITHKLINE BEECHAM~ENG3376A4~1~IM~RA~HEP B (ENGERIX-B)~2|PPV~MERCK & CO. INC.~0044J~1~IM~LA~PNEUMO (PNEUMOVAX)~2|TD~CONNAUGHT LABORATORIES~U0114BA~2~IM~RA~TD ADSORBED (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0162470	11/22/2000	WI	73.0	73		F	11/16/2000	Had a flu shot on 11/4/99 and on 11/6/99, noticed bones ached and had a flu-like feeling. Health deteriorated soon after the flu vaccine was administered. On 11/21/99, started to have arm pains in both arms. On 12/15/99, had severe back pains, was treated with a strong medication, which caused the immune system to weaken. On 12/26/00, back pain was gone. On 1/20/00, was hospitalized for 5 days. Back pain lasted 4-5 weeks, but arm pain continued for 5 months. On 6/5/00, came down with a case of shingles, which has gone into post herpetic neuralgia. At this date, still suffering from shingles pain.					Y	5			N	11/04/1999	12/15/1999	41		PVT	UNK	NONE	NONE	NONE			1						1	Back pain; Bone pain; Herpes zoster; Immune system disorder; Infection; Influenza like illness; Neuralgia; Pain	FLU3~PFIZER\WYETH~4998214~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0162510	11/22/2000	CA	75.0	75		F		The pt experienced a headache, severe swelling and red splotches on swollen area, lasting 1 week. The pt took Tylenol and used ice pack on swollen area.									Y	10/28/2000	10/28/2000	0		PVT	UNK		NONE				1						1	Erythema; Headache; Oedema; Rash maculo-papular	FLU3~AVENTIS PASTEUR~U0400AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0944K~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0162511	11/22/2000	IN	74.0	74		F	11/14/2000	48 hours post vax, the pt experienced chills, fever, dizziness, weakness, paleness and hoarseness. The pt felt lousy for 2 weeks.									Y	10/31/2000	11/02/2000	2		PUB	UNK		NONE	NONE			1						1	Asthenia; Dysphonia; Malaise; Pallor; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0162512	11/22/2000	NY	70.0	71		F	11/20/2000	The pt experienced chills, fever, sore throat, and cough. Saw an MD on 11/7/00. Treated with Vantin, saw MD on 11/20/00, Erythromycin given. The pt still has chills and coughing.				Y					N	11/02/2000	11/04/2000	2		PUB	PVT	NONE	NONE	allergy to aspirin, sulfur			1						1	Cough; Pharyngolaryngeal pain; Pyrexia	FLU3~AVENTIS PASTEUR~U0416DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162513	11/22/2000	ND	69.0	69		F	11/16/2000	The pt says that one hour post vax she could not extend arm in upward position.				Y					Y	10/31/2000	10/31/2000	0		PVT	UNK	K-Dur, Verelan, Synthroid, Aerobid inhaler, Albuterol inhaler, aspirin, Lasix, Prilosec		HTN, goiter, peptic ulcer disease, cervical arthritis, melena, hypothyroidism, abdominal pain, COPD, DVT, chronic diarrhea, macular degeneration, recurrent UTI			1						1	Hypokinesia	FLU3~AVENTIS PASTEUR~U0333AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162514	11/22/2000	IL	73.0	73		M	11/05/2000	The pt became lightheaded and dizzy, experienced aching limbs, leg restlessness, balance disorder, weakness in left leg and hand and slurring of speech.				Y					N	10/25/2000	10/25/2000	0	MRI head	OTH	OTH	theophalyne, cozar, Serevent, Vanceril		asthma, high blood pressure			1						1	Balance disorder; Dizziness; Dysarthria; Hemiparesis; Pain; Restless legs syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0162515	11/22/2000	CO	79.0	79		F	11/16/2000	The pt experienced pain in bilateral arms with severe swelling and numbness to the right hand. The pt also experienced pain in the neck and right arm and then left arm with hot flushes and chills. On exam, the pt had a hot, red, edematous right wrist that was tender with decreased range of motion of neck, all fields. Remainder of exam within normal limits.				Y					Y	10/26/2000	10/27/2000	1	ESR - 66, RA - 61, WBC - 12.1, Glucose - 163, ANA - pos	PVT	PVT	Zoloft, Voltaren, Premarin, Synthroid	NONE	depression, hypothyroidism, degenerative joint disease. menopause			1						1	Antinuclear antibody positive; Arthralgia; Blood glucose increased; Chills; Erythema; Hot flush; Hypoaesthesia; Leukocytosis; Neck pain; Oedema peripheral; Pain; Red blood cell sedimentation rate increased	FLU3~AVENTIS PASTEUR~U0402AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~470588~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0162516	11/22/2000	MN	33.0	33		F	11/19/2000	The pt experienced a fever beginning immediately. Started low and peaked about 6 hours and stayed high about 6 hours. The pt also experienced aches and chills lasting 36 hours. The pt also experienced nausea and vomiting and cold sweats.									Y	11/04/2000	11/04/2000	0		OTH	PVT	NONE	NONE	NONE			1						1	Feeling cold; Hyperhidrosis; Nausea; Pain; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0162517	11/22/2000	NC	46.0	46		F	11/16/2000	The pt immediately experienced pain, 2-4 edema and redness with swelling. This lasted 4 days. Was still red for 2 weeks.									Y	11/02/2000	11/02/2000	0		PVT	PVT	Toprol, Paxil	NONE	PCN allergy			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~MEDEVA PHARMA, LTD.~E6733DKA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0162518	11/22/2000	MI	20.0	20		F	11/13/2000	The pt experienced hives and rash within 45 minutes post vax.				Y					Y	11/13/2000	11/13/2000	0	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Rash; Urticaria	FLU3~AVENTIS PASTEUR~U0398AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162519	11/22/2000	FL	28.0	28		F	11/17/2000	The pt experienced a large red swollen area on the arm, the area is hot. Took Motrin and used cold compresses to treat.									U	11/16/2000	11/16/2000	0		PVT	OTH	Ortho-Novum	NONE	seasonal allergies			1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~AVENTIS PASTEUR~U0735AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162520	11/22/2000	CT	28.0	28		F	11/08/2000	The pt experienced a rash to the arms, legs and abdomen with a fever and pulse of 82 and respirations of 16.									Y	11/07/2000	11/08/2000	1	throat culture	OTH	OTH		pharyngitis	allergy to sulfa, positive PPD			1						1	Pyrexia; Rash	FLU3~AVENTIS PASTEUR~U0422BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162521	11/22/2000	WA	36.0	36		F	11/15/2000	12 hours post vax the pt experienced arterial fibrillation. Went tot he ER. Received IV treatment and oral Diltiazam.				Y					Y	11/06/2000	11/07/2000	1	TSN, CBC, BMP - all neg	PUB	PUB	prenatal vitamins	NONE	NONE			1						1	Atrial fibrillation	FLU3~AVENTIS PASTEUR~U0398AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162522	11/22/2000	NY	41.0	41		F	11/03/2000	One day post vax, the pt developed a reddened arm and diarrhea.									U	10/30/2000	10/31/2000	1		UNK	UNK	NONE	NONE				1						1	Diarrhoea; Injection site erythema	FLU3~AVENTIS PASTEUR~U0415AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162523	11/22/2000	FL	42.0	42		F	11/17/2000	The pt experienced redness, swelling within 5  minutes at injection site.									Y	11/16/2000	11/16/2000	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site oedema	FLU3~AVENTIS PASTEUR~U0435AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162524	11/22/2000	OH	50.0	50		F	11/16/2000	The pt became pale, dizzy, lips got blue, pulse of 56. An ambulance was called.				Y					Y	11/16/2000	11/16/2000	0		PUB	PVT	NONE	NONE	NONE			1						1	Cyanosis; Dizziness; Pallor	FLU3~MEDEVA PHARMA, LTD.~E71300LA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0162553	11/24/2000	OK	65.0	65		F	11/22/2000	Got shot about 08:20, noted right eye tearing at bedtime that night. The next morning the right eye was hurting and tearing and left side of mouth drooping, saliva discharge, headache. Being treated with steroids for Bell's Palsy.				Y	Y	1			Y	11/17/2000	11/17/2000	0	Cat Scan and MRI; had allergy testing (allergic to 100 out of 114 allergies) unsure what.	PUB	UNK	blood pressure meds	NONE	elevated blood pressure, allergy to PCN, HTN, ischemic heart disease, arterosclerotic heart disease			1						1	Coronary artery disease; Drooling; Eye pain; Facial palsy; Headache; Hypersensitivity; Hypertension; Lacrimation increased; Myocardial ischaemia	FLU3~PFIZER\WYETH~4008179~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0162573	11/24/2000	IL	68.0	68		F		On 10/30 the pt experienced a cough, headache, fever. On 10/31 the pt experienced general aches to the right leg. On 11/1, the pt felt better with a decrease in back and leg aches. 11/2, the pt developed a sore throat.									Y	10/28/2000	10/30/2000	2		PUB	PUB	Synthroid	NONE	allergy to sulfa		IL00060	1						1	Back pain; Cough; Headache; Pain; Pharyngolaryngeal pain; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E64300HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0162581	11/24/2000	TX	49.0	49		F	11/21/2000	The pt was given Pneumovax and developed right arm (?) with a fever of 99.3. WBC elevated. The MD states I suspect this is related to administrated techniques not to serum.				Y					U	11/14/2000	11/15/2000	1	WBC - elevated	OTH	PVT	NONE	NONE	migraine headaches			1						1	Injection site reaction; Pyrexia; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~470593~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~U0423AA~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0162595	11/27/2000	IL	56.0	55		M	11/20/2000	Post vax, the pt developed lack of mobility in extremities, loss of muscular nerve functions, blurred vision, cataracts, and  pain in all joints. Treatment included medication. Follow up information received 09/18/02 states Pain in all joints of body (ie- neck, arms, legs(Knees), Difficulty in walking, getting up from sitting positions, Sleep is affected, fatigue, general weakness over entire body, conditions gets worst each month..			Y	Y				Y	N	10/12/1999	10/12/1999	0	X-rays, EMG's, MRI, blood testing and monitoring of kidney and liver functions	OTH	OTH	Vasotec, Lipitor, Inderal	NONE	Hypertension and high cholesterol			1						1	Arthralgia; Asthenia; Cataract; Difficulty in walking; Hypokinesia; Nerve injury; Vision blurred	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~SMITHKLINE BEECHAM~2597A2~3~IM~~HEP B (ENGERIX-B)~1	USA	Life Threatening,Disabling	Influenza
0162600	11/27/2000	IL	59.0	59		F	11/22/2000	The pt experienced 3 red spots, one the size of a quarter and 2 the size of dimes, 2 to 3 inches below the injection site on the left arm and the pneumonia vax. Not itchy or painful, flat not raised.									Y	11/20/2000	11/22/2000	2	NONE	PUB	PVT	Vitamins, Prempro, Xanax	NONE	allergy to cough medicines	fever, aches~Polio Virus, Oral (no brand name)~3~0.00~In Patient		1						1	Erythema; Rash	FLU3~AVENTIS PASTEUR~U0414BB~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0690K~1~IM~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0162601	11/27/2000	SC	27.0	27		F	11/22/2000	The pt experienced a bronchospasm and urticaria within 24 hours of receiving the vaccine.				Y					Y	10/16/2000	10/17/2000	1		PVT	PVT	NONE	NONE	Flagyl			1						1	Bronchospasm; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E66350HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0162602	11/27/2000	MS	63.0	63		F	11/15/2000	The pt felt nauseated and chilled the day following the vaccines. The pt had 3 small red patches below the area where the vaccines were given and the arm was tender and sore and slightly swollen and itching. Symptoms resolved the next day.									Y	11/14/2000	11/15/2000	1		OTH	PVT	NONE	NONE	allergy to sulfa drugs			1						1	Chills; Erythema; Nausea; Oedema; Pain; Pruritus; Rash	FLU3~PFIZER\WYETH~4008172~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1068K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0162623	11/27/2000	ME	66.0	66		M	11/16/2000	Post vax, the pt developed swelling from shoulder down to fingers.									Y	11/14/2000	11/14/2000	0		PUB	PUB		NONE				1						1	Oedema peripheral	FLU3~MEDEVA PHARMA, LTD.~E59960GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0710K~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0162637	11/28/2000	WI	85.0	85		F	11/14/2000	The pt developed dizziness, nausea, and vomiting for one week occurring 3 days post vax.					Y				Y	11/02/2000	11/10/2000	8	Nasal influenza EIA-neg	UNK	UNK		Diabetes	right temporal lobe meningitis			1						1	Dizziness; Nausea; Vomiting	FLU3~AVENTIS PASTEUR~U0416DA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0162650	11/28/2000	CA	68.0	67		M	11/13/2000	The pt began to have kidney pain with a fever and chills within 1 hour post vax. The pt also experienced a poor appetite for several days and dry heaves.									Y	11/09/2000	11/09/2000	0		PUB	PUB	NONE	NONE	NONE		CA000128	1						1	Decreased appetite; Pyrexia; Renal pain; Retching	FLU3~MEDEVA PHARMA, LTD.~E67330KA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0162652	11/28/2000	NC	33.0	33		F	11/08/2000	Following vax, the pt experienced a lump in throat and felt flushed all over. Within a few minutes, the pt began to clear throat, voice was hoarse, had trouble breathing and talking. The pt was in a supine position and had an occasional faint wheeze. Pt was given adrenaline. After 30 minutes the pt returned to work.									Y	11/08/2000	11/08/2000	0	NONE	PUB	PUB	PPD, Cefzil, Prozac	serous infection	NONE		NC00090	1						1	Dysphonia; Dyspnoea; Flushing; Pharyngeal oedema; Wheezing	FLU3~MEDEVA PHARMA, LTD.~E71300LA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0162655	11/28/2000	AK	69.0	69		F	11/15/2000	The pt experienced a left arm that was swollen from the site of injection to the elbow. The pt also experienced redness, warmth to the touch, and chills that evening. Some nausea was also experienced.									Y	10/31/2000	10/31/2000	0	NONE	PUB	PUB	oral medication for diabetes	NONE	diabetes, breast cancer		AK200030	1						1	Chills; Injection site erythema; Injection site oedema; Injection site warmth; Nausea	FLU3~PFIZER\WYETH~408171~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~459837~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0162659	11/28/2000	AK	44.0	44		F	11/06/2000	About 12 hours post vax, the pt's left arm was sore, hard to move and then developed redness, burning sensation and swelling. Improving now 72 hours later.				Y					U	11/03/2000	11/03/2000	0	NONE	PUB	PUB	Slovent, Serevent, Claritin	sore throat	asthma, allergy to dogs		AK200034	1						1	Hypokinesia; Injection site erythema; Injection site oedema; Injection site pain; Pain; Skin burning sensation	FLU3~PFIZER\WYETH~4008171~7+~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~459837~3~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0162660	11/28/2000	AK	67.0	67		M	11/06/2000	The pt experienced chills that began a few hours post vax and continued 48 hours. Also redness at the injection site, about a 6 area, and warmth. The pt can use arm.									Y	11/03/2000	11/03/2000	0	NONE	PUB	PUB		NONE	NONE		AK200035	1						1	Chills; Injection site erythema; Injection site warmth	FLU3~PFIZER\WYETH~4008171~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~459837~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0162664	11/28/2000	PA	71.0	71		M	11/21/2000	The pt experienced itchy groin, stomach, legs, progressing to neck and chest. No rash. Treated with calamine lotion and Benadryl provide temporary relief. MD prescribes over the phone hydroxyzine, good relief provided.									Y	11/15/2000	11/16/2000	1		PUB	PUB		NONE	NONE			1						1	Pruritus; Pruritus; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E59070GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~E59070GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0162665	11/28/2000	CA	49.0	49		F	11/06/2000	The pt felt a sharp pain to the left shoulder and arm at the time of injection. Moderate edema and redness at the injection site for 1 hour. No improvement after 3 days. The pt was seen by MD. Treated with Motrin and warm packs.				Y					Y	11/01/2000	11/01/2000	0	NONE	PUB	PUB		NONE	diabetes, chronic pulmonary disease, sleep apnea		CA000117	1						1	Injection site erythema; Injection site oedema; Injection site pain; Pain	FLU3~MEDEVA PHARMA, LTD.~E67380KA~1~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0162666	11/28/2000	CA	47.0	47		F	11/13/2000	The pt experienced a fever of 101, myalgia, arthralgias, sore arm at injection site, lasting 24 hours.									Y	11/09/2000	11/10/2000	1		PUB	PUB	Interferon	hepatitis C Treatment	hepatitis C		CA000118	1						1	Arthralgia; Injection site pain; Myalgia; Pyrexia	FLU3~AVENTIS PASTEUR~U0409AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162668	11/28/2000	CA	71.0	71		F	11/09/2000	On 11/3, the pt experienced discomfort in left arm following vax. Red and sore all night. 11/4 symptoms worsening, soreness, redness and swelling advancing down arm but not interfering with activities. Took aspirin. 11/5 symptoms intensifying, most swelling now between elbow and hand, not feeling well. Pt went to the ER and Keflex was prescribed. 11/6 pt is much better, swelling is down. 11/7, no redness or swelling only a little sore.				Y					Y	11/03/2000	11/04/2000	1	NONE	PUB	PUB	Tetracycline, Avista	NONE	breast cancer, allergy to antibiotic		CA000120	1						1	Injection site erythema; Injection site oedema; Injection site pain; Malaise; Oedema peripheral	FLU3~MEDEVA PHARMA, LTD.~E67940KA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~469133~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0162676	11/28/2000	IA	6.0	5		M	11/22/2000	The pt experienced shingles on the right arm 11 days post vax.									U	11/09/2000	11/21/2000	12		PVT	PVT	Digoxin, ASA	NONE	pulmonary atresia			1						1	Herpes zoster; Infection	FLU3~PFIZER\WYETH~4108213~4~IM~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0162679	11/28/2000	WA	54.0	53		F	11/20/2000	15 minutes post vax, the pt complained of nausea, chest tightness, cool clammy skin, P-100, BP 140/90. Ambulance was called, but the pt was not transferred anywhere. Pt returned home.									Y	11/20/2000	11/20/2000	0	NONE	PUB	PUB	Claritin, Albuterol		asthma, allergy to foods			1						1	Chest discomfort; Cold sweat; Hypertension; Nausea; Tachycardia	FLU3~PFIZER\WYETH~4008174~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0162681	11/28/2000	CA	42.0	42		F	11/20/2000	The pt experienced a flushed face that was red, tingling scalp, spread to arms and was itching. The pt took Benadryl and felt better. Still had minor symptoms and rash on the day following the vax.									Y	11/17/2000	11/17/2000	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Flushing; Paraesthesia; Pruritus; Rash	FLU3~PFIZER\WYETH~4008177~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0162682	11/28/2000	MS	79.0	79		F	11/17/2000	The pt complained of edema extending to the right elbow. Inflammation extending to right elbow, and itching at the site of injection.				Y					Y	11/15/2000	11/16/2000	1		PUB	UNK	Prempro, Pravachol, Synthroid				MS00045	1						1	Injection site hypersensitivity; Injection site inflammation; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4008175~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~459837~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0162690	11/28/2000	WA	27.0	27		F	11/17/2000	The pt developed a severe headache and muscle spasms in her neck and thighs. 48 hours later, the pt developed bleeding gums and swollen lips saw her physician on 11/16 and was treated with a prescription antihistamine.				Y					Y	11/14/2000	11/14/2000	0	NONE	PVT	PVT	NONE	NONE	allergy to codeine, morphine, vicodan, percodan			1						1	Face oedema; Gingival bleeding; Headache; Muscle spasms	FLU3~MEDEVA PHARMA, LTD.~E59960GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0162695	11/28/2000	MO	35.0	35		U		The pt experienced hives all over with itching and irritability.									N	11/10/2000	11/12/2000	2		PVT	PVT	Humalog, Synthroid		diabetes, thyroid			1						1	Irritability; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0162703	11/28/2000	MI	72.0	72		F	11/22/2000	Following vaccine, the pt developed soreness, redness, hot to the touch, swelling from shoulder to elbow, nausea. Symptoms continued for 2 days.				Y					U	11/20/2000	11/20/2000	0	UNK	PUB	PUB	Amaryl, Norvasc, Glucophage	NONE	diabetes, hypertension, glaucoma			1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth; Nausea	FLU3~AVENTIS PASTEUR~U0417AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162705	11/28/2000	NY	52.0	51		F	11/22/2000	One day post vax, the pt experienced hives on top of hands, chest, face. Treated with Mediol Dose pack for 1 week.									Y	11/07/2000	11/08/2000	1		PUB	UNK	Prempro, Claritin	NONE	environmental allergies			1						1	Urticaria	FLU3~PFIZER\WYETH~4008173~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0162706	11/28/2000	FL	84.0	84		M	11/20/2000	The patient had sensitivity to touch 11/9 at 10PM, red spots 11/10 AM spreading from shoulders progressively down to thighs, front and back; it felt like sunburn. On 11/10 in the PM the doctor advised antihistamine every 4 hours, he slept poorly. Began to fade 11/14.									Y	07/09/2000	07/09/2000	0	NONE	PVT	UNK	Inderal, Lanoxin	Heart condition	No allergies			1						1	Erythema; Hyperaesthesia; Sleep disorder; Urticaria	FLU3~AVENTIS PASTEUR~UO402CA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162713	11/28/2000	WI	5.0	5		M	11/15/2000	The pt experienced an onset of wheezing, asthma. The pt also experienced a rash, that was pruritic on the arm at the injection site, lasting greater than one week. Treated with hydrocortisone cream.				Y					Y	11/08/2000	11/08/2000	0	NONE	PVT	PVT	Singulair, Albuterol	NONE	Asthma			1						1	Injection site rash; Pruritus; Wheezing	FLU3~AVENTIS PASTEUR~U0415AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162714	11/28/2000	PA	62.0	61		F	11/21/2000	The pt reported the day following the vaccine, she felt nervous and anxious.									Y	10/24/2000	10/25/2000	1		PVT	OTH	blood pressure	HTN	anxiety attacks			1						1	Anxiety; Nervousness	FLU3~AVENTIS PASTEUR~U0399AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162715	11/28/2000	CA	73.0	73		F	11/19/2000	The next morning following the vax, the pt complained of a sore throat, coughing, had phlegm, had to blow nose. The pt called the triage nurse. The pt was told to treat the symptoms as a cold. Treated with Codeine Cough at night and OTC during the day.									Y	11/02/2000	11/03/2000	1	NONE	OTH	OTH	Levoxyl, Premarin		Arthritis, allergy to PCN, Flagyl, ibuprofen			1						1	Cough; Nasopharyngitis; Pharyngolaryngeal pain	FLUX~UNKNOWN MANUFACTURER~E6738OKA~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0162716	11/28/2000	TX	12.0	12		M	11/20/2000	Within 10 minutes of getting the vaccine, the pt experienced dizziness, turning pale, became blue, diaphoretic, headache and stomach ache. Got better over the next 1/2 hour. He was laid down and he got better. Probable vasovagal response.				Y						11/20/2000	11/20/2000	0	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Abdominal pain upper; Cyanosis; Dizziness; Headache; Hyperhidrosis; Pallor; Syncope vasovagal	FLU3~PFIZER\WYETH~4008209~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0162717	11/28/2000	CA	38.0	38		F	11/19/2000	The pt started spotting, then started cycle within 12 hours of vax. This was only after 12 days from previous cycle.									Y	11/02/2000	11/02/2000	0		PUB	PVT	NONE	NONE	NONE			1						1	Menstruation irregular	FLU3~MEDEVA PHARMA, LTD.~E59970GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0162720	11/28/2000	CA	37.0	37		F	11/20/2000	The pt reported experiencing nausea and body aches, not feeling well. The pt experienced a hive type rash. Presented to ER. Given Benadryl for treatment. No further treatment needed.				Y					Y	11/17/2000	11/17/2000	0	NONE	PVT	PUB	Albuterol, Azmacort, Atrovent, Accolate	NONE	Asthma			1						1	Malaise; Nausea; Pain; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E66330HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0162722	11/28/2000	NY	71.0	71		F	11/19/2000	The patient has had sneezing, nosebleeds, coughing, chest tightness, and heavy breathing. He consulted with a physician who concluded that it was a strain of flu, but not from vaccination. Prescribed rest, aspirin, cough medicine, lots of fluids (soups and tea). This lasted 2 weeks for complete recovery.									Y	11/03/2000	11/04/2000	1		OTH	OTH	Aspirin, Lipitor, Toprolxl, Isosorbide MN		Heart condition, high cholesterol	swelling, skin hot, and tender~Tetanus Toxoid (no brand name)~~69.00~In Patient		1						1	Chest discomfort; Cough; Epistaxis; Hyperventilation; Sneezing	FLUX~UNKNOWN MANUFACTURER~V0415AA~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0162724	11/28/2000	NJ	62.0	61		F	11/15/2000	The pt experienced difficulty breathing, heart palpitations, lightheadedness, severe pains in rib area, extremely weak and nauseous.				Y					Y	11/01/2000	11/01/2000	0		PUB	UNK	Cardizem, aspirin, isodoris, Zoloft, Zocor		allergy to PCN, Angina			1						1	Abdominal pain; Asthenia; Dizziness; Dyspnoea; Nausea; Palpitations	FLU3~AVENTIS PASTEUR~U0408CA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162725	11/28/2000	CA	60.0	60		M	11/17/2000	The pt awoke one day post vax with shaking chills.									Y	11/07/2000	11/08/2000	1	NONE	PUB	UNK	Lotensin, Cardizem, ASA, ibuprofen	NONE	HTN, subsequent hemorrhage			1						1	Chills; Tremor	FLU3~MEDEVA PHARMA, LTD.~E67940KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0162749	11/29/2000	NY	66.0	66		F	11/21/2000	Unclear! Pt developed chest pain and shortness of breath, progressive with orthopnea. Admitted to the hospital with mild hypoxemia and pericardial effusion.					Y				Y	10/17/2000	11/01/2000	15	ECG-Pericardial effusion (no constructive changes); CPK-nml; Troponin-nml; old ECG changes	PVT	PVT	Plendil, Flovent, albuterol, Detrol, prednisone, Vioxx, Restoril	CRST/Sjogren's syndrome; COPD; HBP	Allergies to sulfa meds, CRST/Sjogren's syndrome, COPD, HBP			1						1	Chest pain; Dyspnoea; Hypoxia; Pericardial effusion	FLU3~MEDEVA PHARMA, LTD.~E64320HA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0162750	11/29/2000	OR	82.0	82		F	11/21/2000	Spontaneous report received on 11/16/00, from a Medical Assistant in a Dermatologist's office, regarding an adverse event possibly related to administration of Fluvirin. On 10/6/00, this 83 year old female, shortly post vax, developed a fever of 102F, chills and general malaise. These symptoms lasted approx. 4 days. In mid-October, she developed lesions on her hands and in her mouth. She was treated with an unspecified course of prednisone with symptom abatement. After completion of the prednisone, topical use of Orabase and Kenalog; lesions remain at the time of this report. The dx of Stevens-Johnson Syndrome has been made. The reporter stated that the Dermatologist's office has treated this pt for over 10 years. She indicates that the pt is normally very mentally there, but that the pt hasn't been herself. She describes pt as being easily confused and forgetful. Additional information has been requested from the physician. The follow up received on 3/22/01 states, vaccine reaction onset date Stevens Johnson Syndrome Oct 2000, fever and chills 10/6/00, malaise 10/6/00, forgetful October 2000, and confused October 2000.									N	10/06/2000	10/06/2000	0		PVT	OTH	Cozaar, Norvasc, temazepam, clidinium, chlordiazepoxide, levothyroxine		Hypertension; pharyngitis; hypothyroidism, gastrointestinal problems, increased weight loss		MPI2000049220	1						1	Confusional state; Malaise; Memory impairment; Mouth ulceration; Pyrexia; Skin ulcer; Stevens-Johnson syndrome	FLU3~MEDEVA PHARMA, LTD.~E67320HA~UNK~UN~GM~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0162760	11/29/2000	MN	63.0	63		M	11/20/2000	In February-March 2000, the pt developed pneumonia. The pt sought unspecified medical attention. Follow-up information received from the pharmacist on 11/6/00 indicated that in 2/00 and 3/00 the pt was sick with pneumonia. It was reported that the pt had chest x-rays, several doctor visits, and was treated with three different antibiotics. As of 10/00, it was reported that the pt partially recovered but still had a persistent cough and shortness of breath. The pharmacist indicated that the pneumonia resulted in a persistent or significant disability/incapacity for the pt. Additional information has been requested. Followup received from RN at doctor's office indicates pt vaccinated in October of 1998 (although initially reported in 1999) and has had intermittent difficulties with cough and was last seen in January 2001 with a 1 day history of cough. Pt diagnosed with bronchitis and antibiotics were ordered. Pt instructed to return if did not improve and he has not returned. No further info is expected.				Y				Y	Y	10/01/1999	02/01/2000	123	CXR-2/1/00	UNK	UNK	aspirin, Zocor		UNK		WAES00100269	1						1	Bronchitis; Cough; Dyspnoea; Pneumonia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0162790	11/29/2000	CA		74		M	11/27/2000	The pt developed a rash on the thighs, upper extremities, dermatitis and eczema.									Y	11/09/2000	11/11/2000	2		OTH	OTH		UNK	asthma, hypertension			1						1	Dermatitis; Eczema; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0162792	11/29/2000	WA	61.0	61		F		One day post vax, the pt experienced fatigue and beginning flu symptoms. The pt also experienced difficulty breathing. The pt saw her PMD on 11/20/00.				Y					U	11/15/2000	11/16/2000	1		PVT	PVT		NONE	NONE			1						1	Dyspnoea; Fatigue; Influenza like illness	FLU3~PFIZER\WYETH~4008180~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0162799	11/29/2000	TX	68.0	68		F	11/14/2000	The pt experienced induration and soreness, myalgia started about 2 1/2 hours post vax. The are was 159 x 89 mm size on 11/14/00, about 20 hours post vax.									Y	10/13/2000	11/13/2000	31		PUB	PUB	Claritin, Prempro, Norvasc	NONE	Lymphoma			1						1	Injection site induration; Injection site pain; Myalgia	FLU3~PFIZER\WYETH~4008173~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~474936~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0162800	11/29/2000	FL	72.0	72		F	11/21/2000	One day post vax, the pt complained of feeling confused for several hours, also states her legs were wobbly and that she had a fever and aches. These lasted about 3 hours.									Y	11/15/2000	11/16/2000	1		PUB	PVT	high blood pressure medication	NONE	high blood pressure, thyroid problems			1						1	Balance disorder; Confusional state; Pain; Pyrexia	FLU3~AVENTIS PASTEUR~U0423AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162802	11/29/2000	MD	31.0	31		F	11/22/2000	Sensory peripheral neuropathy treated with Neurontin/Ultram.				Y					N	11/09/2000	11/13/2000	4	MRI-neg; C-Spine-neg	PVT	PVT	NONE	NONE	NONE			1						1	Neuropathy peripheral; Sensory disturbance	FLU3~AVENTIS PASTEUR~U0421AA~1~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162805	11/29/2000	IN	79.0	79		F	11/22/2000	Swelling of arm; from upper arm to elbow.				Y					U	11/09/2000	11/09/2000	0	NONE	PVT	PVT	Tylenol, vitamins, calcium	NONE	Allergy to PCN, Darvon, ASA			1						1	Injection site swelling	FLU3~AVENTIS PASTEUR~U0337AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1531J~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0162807	11/29/2000	SD	83.0	83		F	10/25/2000	Reddened area on left deltoid; like burn, warm to touch.									Y	10/20/2000	10/20/2000	0	NONE	PVT	PVT	Aprazolam, Paxil, Coumadin, Digoxin, Metoprolol	Degenerative arthritis; recent onset of atrial fibrillation; depression	Degenerative arthritis; anxiety; atrial fibrillation, depression			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~AVENTIS PASTEUR~U0333AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0045J~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0162809	11/29/2000	MD	25.0	25		F	11/24/2000	Large 5cm X 6cm raised rash treated with hydrocortisone. Symptoms appeared the night of initial injection.									Y	11/21/2000	11/21/2000	0	NONE	PUB	PUB	Birth control pills; Ortho-cycline	NONE	NONE			1						1	Injection site swelling; Rash erythematous	FLU3~PFIZER\WYETH~4008171~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0162812	11/29/2000	PA	47.0	47		F	11/16/2000	Pruritic macular rash over arms, legs, back and trunk. Treated with Benadryl and cimetidine, then prednisone.				Y					Y	11/15/2000	11/15/2000	0		PVT	PVT	Synthroid, Ortho-Novum	NONE	Hypothyroidism, aortic valve replacement			1						1	Pruritus; Rash macular	FLU3~AVENTIS PASTEUR~U0406AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162813	11/29/2000	CT	49.0	49		F	11/22/2000	I vaccinated client at 05:00 and at 06:15, client returned to me complaining of pain in wrists, ankles and hips. Upon inspection, I noted that her wrist and ankles appeared swollen. She also, complained of feeling achy all over her body. She further complained of feeling very thirsty. I called the manufacturer at 06:30 and was advised to have client be seen by MD.				Y					Y	11/22/2000	11/22/2000	0		OTH	PUB	NONE	NONE	NONE			1						1	Arthralgia; Joint swelling; Pain; Thirst	FLU3~AVENTIS PASTEUR~U0428AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0162817	11/29/2000	KS	3.0	2	1	F	11/21/2000	Daughter had breakout of huge hives all over with a temperature of 99F to 100F. Friday morning, 10/20/00 at 08:00, face, neck, back, legs, feet, between eyelash and eyebrow, stomach, private area and hands, etc. Dr on call, prescribed Benadryl. Daughter was finally clear of hives Sunday night or Monday morning. She had red blotches on back also; very uncomfortable and fussy, miserable and kicking legs.									Y	10/19/2000	10/20/2000	1	NONE	PVT	OTH	baclofen, phenobarbital, Inhaler, albuterol and cromolyn	NONE	Cerebral Palsy, asthma, microcephaly			1						1	Irritability; Pyrexia; Rash macular; Urticaria	FLU3~AVENTIS PASTEUR~U0405AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162859	11/30/2000	TX	41.0	41		F	11/13/2000	Pt's arm extremely red, swollen and hot to touch; measured 10 cm X 20 cm around the site of injection.									U	11/10/2000	11/11/2000	1	NONE	UNK	UNK	NONE		Allergy to sulfa.			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~AVENTIS PASTEUR~U0403AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162864	11/30/2000	AK	49.0	49		F	11/08/2000	Soreness and aching at the site of injection for the past year. No Rx. Pt received the vaccine at a local store in lobby site.									N	10/01/1999	10/01/1999	0		OTH	PVT	Lipitor, Deseril	NONE	NONE			1						1	Hypersensitivity; Injection site pain; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0162865	11/30/2000	OH	46.0	46		F	11/29/2000	24 hours, post vax, the pt had edema beneath left arm with soreness. States she felt like a baseball was under her arm. It is still swollen and tender but not swollen now.									Y	11/22/2000	11/23/2000	1	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Injection site pain; Injection site swelling	FLU3~PFIZER\WYETH~4008178~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0162869	11/30/2000	IL	74.0	74		M	10/05/2000	Fever of 101F, swelling and tender.									Y	11/01/2000	11/01/2000	0		OTH	OTH	Tylenol		NONE			1						1	Hypersensitivity; Pain; Pyrexia; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0162970	11/30/2000	CT	69.0			F	11/17/2000	Pt received Fluzone on 10/11/00. Presented to clinic with diarrhea, hematoemesis and was admitted on 10/12/00 to hospital with suspicion and subsequent dx of C. Difficile colitis. Pt subsequently, developed acute severe hypercarbic respiratory failure after several days of pulmonary edema. On 11/14/00, suspects respiratory failure from possible muscle weakness. Possible Guillain-barre, however, CSF on 11/14/00, revealed normal protein suggesting that Guillain-Barre is not an etiology of the respiratory failure.					Y					10/11/2000	11/12/2000	32	CSF-31 on 11/14/00, revealed normal total protein suggesting Guillain-Barre is not an etiology of the respiratory failure.	UNK	UNK	ampicillin 1 gm IV, Solu-Medrol IV 60mg q6, Ciprofloxacin 500mg po, albuterol nebs 3 ml q4		Locally advanced metastatic breast cancer; development of pulmonary edema secondary to CHF			1						1	Diarrhoea; Haematemesis; Hypercapnia; Infection; Muscular weakness; Respiratory failure	FLU3~AVENTIS PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|UNK~UNKNOWN MANUFACTURER~~UNK~~~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0162942	12/01/2000		39.0	39		M	11/27/2000	Pt received flu vaccine on 11/23/00 and developed Bell's Palsy to left side of face, within 24 hours, post vax.										11/23/2000	11/26/2000	3		UNK	UNK						1						1	Facial palsy	FLU3~PFIZER\WYETH~4008180~UNK~SC~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0162952	12/01/2000	TX	51.0	51		F	11/28/2000	Pt stated that 1 shot was given in the left shoulder/arm joint and that the 2nd was given in the back of the arm. In less than an hour, the left arm became swollen; eventually became 4 larger than the right arm. PMD's dx: Cervical nerve plexus, secondary to placement of shots. Left arm hurt, felt heavy, fingers drawn up. Treatment: cold/heat packs to arm. Swelling reduced by half as of 11/21/2000.				Y					Y	11/09/2000	11/09/2000	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Injection site swelling; Nerve compression; Nerve injury; Sensation of heaviness	FLU3~AVENTIS PASTEUR~U0410AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~469133~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0162954	12/01/2000	TX	18.0	18		F	11/29/2000	Pt received Menomune and Flu vaccine on 11/28/00 at 15:45. About 16:00, pt began experiencing shortness of breath, wheezing and chest tightness at about 22:00. Pt presented to health center at 08:00 with wheezing. Pt was given epinephrine, Benadryl and a nebulizer treatment with Proventil. Symptoms resolved and improved.				Y					Y	11/28/2000	11/28/2000	0	Initial flow 210 after treatment was 450; Pulse OX 96% after treatment was 97%.	OTH	PVT	NONE	NONE	NONE			1						1	Chest discomfort; Dyspnoea; Wheezing	FLU3~AVENTIS PASTEUR~00399BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~CONNAUGHT LABORATORIES~7346AA~1~SC~RA~MENINGOCOCCAL (MENOMUNE)~1	USA	Emergency room visit	Influenza
0162958	12/01/2000	OH	72.0	72		M		Pt reports developing itching and non-draining rash on 11/9/00, that has continued to today. Itching and rash is only on left shoulder and upper back, no pustules noted. On his own, pt began taking OTC Benadryl on 11/16/00. Pt has also used rubbing alcohol and Vaseline lotion on rash with little relief.									N	11/07/2000	11/09/2000	2	NONE	PUB	PUB	Lasix, K+, Glucophage, Coumadin, Darvocet, Percocet	NONE			OH00052	1						1	Hypersensitivity; Pruritus; Rash	FLU3~AVENTIS PASTEUR~U0406AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0162959	12/01/2000	TX	48.0	48		M	11/27/2000	Sudden high temperature of 104F, uncontrolled shaking and muscle stiffness.				Y					Y	11/21/2000	11/21/2000	0	Tested for Encephalitis (states client).	OTH	OTH		NONE	Allergy to penicillin			1						1	Musculoskeletal stiffness; Pyrexia; Tremor	FLU3~PFIZER\WYETH~4008180~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0162965	12/01/2000	OH	61.0			F	11/20/2000	Headache, nausea and vomiting and diarrhea, right arm swollen with red rash. Treated with antibiotic IM and pain pills for headache on 11/17/00. On 11/20/00, back to normal per pt.				Y					Y	11/15/2000	11/16/2000	1	NONE	OTH	PVT		NONE				1						1	Diarrhoea; Headache; Injection site erythema; Injection site swelling; Nausea; Rash; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E71270LA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~474937~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0162966	12/01/2000	OR	43.0	43		F	11/27/2000	Swollen, red, hot and tender hand-sized area around injection site, started 1-2 hours after shot.									Y	11/21/2000	11/21/2000	0	NONE	PVT	PVT		Mild URI	NONE	Pain~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~AVENTIS PASTEUR~U0422BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0690K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0162967	12/01/2000	IL	71.0	71		F	11/17/2000	Pt complained of extreme right arm pain, post vax, on 11/3/00. Pt attempted to treat with Tylenol and heat to extremity. On 11/6/00, pt states arm became red and swollen at injection site. Went pt PMD, who prescribed Amoxicillin for cellulitis.				Y					Y	11/03/2000	11/04/2000	1	UNK	PUB	PUB	UNK	UNK	UNK		IL00062	1						1	Cellulitis; Injection site erythema; Injection site pain; Injection site swelling	FLU3~MEDEVA PHARMA, LTD.~E64300HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~12165~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0162971	12/04/2000	CA	32.0			M	11/30/2000	Within 20 minutes, the pt returned to the office with facial swelling, swelling  of his throat, difficulty breathing and angioedema of the face and urticaria under his arms, neck and face. The pt was treated with Benadryl and Depromedrol.			Y	Y					U	11/29/2000	11/29/2000	0		UNK	UNK					U200000864	1						1	Angioneurotic oedema; Dyspnoea; Face oedema; Pharyngeal oedema; Urticaria	FLU3~AVENTIS PASTEUR~U0400AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0162988	12/04/2000	IA	29.0	29		F	11/24/2000	Since then I have had difficulty breathing, rapid pulse, can't catch my breath. Had to go to doctor for this on 11/9/00. He put me on Benadryl (that didn't do the job for my numbness and in my body) so had to go to ER on 11/11/00, for oxygen for my breathing and numbness. Heart beating too fast and pulse and BP high from it.			Y	Y	Y				N	11/08/2000	11/08/2000	0	EKG, CBC and was given oxygen	OTH	PVT			Allergic to molds, yeast and dogs.			1						1	Dyspnoea; Heart rate increased; Hypertension; Hypoaesthesia	FLU3~AVENTIS PASTEUR~U0405AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0163015	12/04/2000	OH	67.0	67		F	05/18/2001	It was reported that a 67 year old female pt received a Fluzone SV '00-'01 vaccination on 10/19/00. Reportedly, 24 hours post vax, the pt developed lack of mobility in both legs, also abdominal pain under her ribs. Dx'd as a mild case of Guillain-Barre Syndrome. Further information requested. From followup correspondence receivedon 12/18/2000 it was reported to ignore pt has had EMG that ruled out Guillian Barre. From the follow-up correspondence received on 05/14/2001, it was reported that the pt recovered from this experience.									Y	10/19/2000	10/20/2000	1		OTH	OTH					U200000863	1						1	Abasia; Abdominal pain upper; Guillain-Barre syndrome	FLU3~AVENTIS PASTEUR~0345AC~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163016	12/04/2000	GA	30.0	30		F	12/01/2000	Post vax, on 11/2/00, pt started feeling achy with muscle fatigue and bone/joint pain. Follow-up with private doctor; he does not think complaints are related to shot. This is a possible/ suspect reaction. Still seeking treatment.									U	10/25/2000	11/02/2000	8	NONE	PVT	PVT	Prozac	NONE				1						1	Arthralgia; Bone pain; Fatigue; Pain	FLU3~AVENTIS PASTEUR~U0406AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163017	12/04/2000	PA	46.0	46		F	11/29/2000	Friday had hardness and bruise noted on left deltoid area. Saturday had generalized malaise and pain radiating from left arm to center of back and burning sensation to toes. Pain in center of back was worse. Cannot raise arms over head. Pain in center of back and left arm burning constantly. Also had a headache. Treated with Tylenol and Advil. Dx'd with acute local flu vaccine reaction. Rx'd with Celebrex and ice to affected arm for 72 hours. Recovering.									N	11/21/2000	11/23/2000	2		PVT	PVT		NONE	NONE			1						1	Back pain; Contusion; Headache; Hypokinesia; Injection site induration; Injection site pain; Malaise	FLU3~PFIZER\WYETH~4008179~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163019	12/04/2000	ND	53.0	53		F		Hives on both arms, hips and thighs. Hives nearly all gone on 12/1/00. No treatment.									Y	11/27/2000	11/28/2000	1		OTH	OTH	Allegra, Advil	NONE	Allergy to PCN and neomycin; Eczema			1						1	Hypersensitivity; Urticaria	FLU3~AVENTIS PASTEUR~U0414BB~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163020	12/04/2000	GA	30.0	30		F	12/01/2000	Employee received flu vaccine on 11/27/00 and on 11/28/00 employee stated that she broke out with welts, which started later in the evening on 11/27/00 and continued on to 11/28/00. Pt also complained of itching, scratches were on her back from itching. She took Benadryl 25mg.									Y	11/27/2000	11/27/2000	0	NONE	PVT	OTH	Zantac, Zyrtec		Sensitive to Latex; sinus allergy			1						1	Pruritus; Urticaria	FLU3~AVENTIS PASTEUR~U0423AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163021	12/04/2000	PA	74.0	74		F	11/22/2000	Feeling listless on Saturday and about 14:00, I ran a fever of 102F, had chills and could not get warm, even after putting on 2 quilts on my bed. Monday morning, about 05:00, the fever broke and the chills went away. Felt like a dish rag for a couple of days.									Y	11/03/2000	11/04/2000	1		UNK	UNK						1						1	Listless; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E59070GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0163022	12/04/2000	NY	70.0	70		F	11/17/2000	Cough, wheezing, shortness of breath, tachycardia and BP elevation. Rx'd Solu-Medrol and Cardizem.				Y					Y	11/15/2000	11/15/2000	0	NONE	PVT	UNK		NONE				1						1	Cough; Dyspnoea; Hypertension; Tachycardia; Wheezing	FLU3~AVENTIS PASTEUR~U0428AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163024	12/04/2000	OH	16.0	16		M	11/24/2000	Arm pain X 2 weeks, post vax, especially with swimming. Pain only with overhead use of arm, localized to exertion of the deltoid.									Y	10/15/2000	10/16/2000	1	NONE	PVT	PVT		NONE	Allergy to IV administration of amoxicillin; causes a rash.			1						1	Hypokinesia; Injection site pain	FLU3~AVENTIS PASTEUR~U0417AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163026	12/04/2000	OH	15.0	15		M	11/24/2000	Sugars high (400+) since flu shot date and complaining of a headache, 2 days later. Referred to Endocrinologist.									Y	11/14/2000	11/14/2000	0	Urine glucose-2000; Keytones-moderate; CBC-WNL on 11/17/2000.	PVT	PVT	Insulin	NONE	Diabetes Mellitus			1						1	Glucose urine present; Headache; Hyperglycaemia; Ketoacidosis	FLU3~AVENTIS PASTEUR~U0417AA~5~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163027	12/04/2000	OK	46.0	46		M	11/27/2000	Pt received Influenza vaccine at 13:40 and at 15:20 had swelling of left side of upper lip. BP was 133/87 and P was 66.									Y	11/27/2000	11/27/2000	0		OTH	OTH	HCTZ, Cozaar, Periostat	NONE	NONE			1						1	Hypertension; Swelling face	FLU3~PFIZER\WYETH~4008180~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0163028	12/04/2000	OK	38.0	38		M	11/27/2000	Redness and itching at the injection site. Treated with Benadryl, at 09:15.									Y	11/27/2000	11/27/2000	0		OTH	OTH	NONE	NONE		Itching~Influenza (Seasonal) (no brand name)~~37.00~In Patient		1						1	Injection site erythema; Pruritus	FLU3~PFIZER\WYETH~4008180~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163033	12/04/2000	CO	57.0	57		M	10/31/2000	Noticed eyes were swollen almost shut, 3 days, post vax. Lips were also swollen. Took Benadryl and went to work. Red blotches developed on face. Over the next several days, hands and toes began itching and more blotches appeared on back, torso, buttocks and legs. Tongue was swollen on 10/30/00 and throat sore and swelling. Saw MD on 10/31/00 and prescribed Zyrtec and Prednisone. Pt felt better later that day.				Y					Y	10/21/2000	10/24/2000	3	Ran pulse ox (normal)	OTH	PVT	NONE	NONE	NONE		CO0023	1						1	Eye swelling; Pharyngeal oedema; Pharyngolaryngeal pain; Pruritus; Rash macular; Tongue oedema	FLU3~MEDEVA PHARMA, LTD.~E64680HA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0163034	12/04/2000	HI	81.0	81		F	11/26/2000	24 hours, post vax, pt developed cough and difficulty breathing (angioedema). Improved by Monday, 9/18/00. Later, on 9/22/00, pt developed bronchitis.									Y	09/15/2000	09/16/2000	1	Peak flow 150cc	PVT	PUB	ASA, atenolol, Sular, Lipitor	NONE	NONE			1						1	Angioneurotic oedema; Bronchitis; Cough; Dyspnoea	FLU3~AVENTIS PASTEUR~U0333AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163036	12/04/2000	PA	26.0	26		F	11/28/2000	5cm X 7cm erythematous, indurated, hot area at injection site. Also had chills, myalgias and headache.									U	11/26/2000	11/27/2000	1	NONE	PVT	PVT	NONE	NONE	Allergy to sulfa (causes a rash)			1						1	Chills; Headache; Injection site erythema; Injection site induration; Injection site warmth; Myalgia	FLU3~PFIZER\WYETH~4008185~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163037	12/04/2000	SC	12.0	12		M	11/17/2000	Mother phoned health dept on 11/15/00 and stated client has hives and itching that developed 3 hours, post vax, and had not resolved. Mother took client to MD on 11/15/00. Requested consent for release of information from MD to health dept. Received 1st flu shot in 1999 without complications per client's mother.				Y					U	11/13/2000	11/13/2000	0		PUB	PUB	NONE	NONE	NONE		SC00068	1						1	Hypersensitivity; Pruritus; Urticaria	FLU3~AVENTIS PASTEUR~U0417AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163041	12/04/2000	MN	61.0	61		M	11/24/2000	Had flu shot at 16:45, central time on 11/4/00, on Saturday. On Sunday afternoon, started with aches and pain. Monday, got worse. Wednesday, developed pleurisy confirmed by X-ray and blood work. I still have drainage and dry cough.									N	11/04/2000	11/06/2000	2	X-ray; WBC-11.3 (up); on Thursday WBC-8.0	OTH	OTH	Coumadin, Cozaar, Lipitor, Synthroid, Allegra, Flonase, Flovent, acetaminophen	NONE	Allergies, asthma, heart			1						1	Chest X-ray abnormal; Cough; Pain; Pleurisy; Pulmonary congestion; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0163045	12/04/2000	OH	43.0	43		F	11/24/2000	Cervical and axillary lymphadenopathy to left side of neck and arm, starting on 11/12/00. Cervical adenopathy present on 11/24/00, axillary lymphadenopathy resolved.									N	11/12/2000	11/12/2000	0		PUB	PVT	UNK	NONE	Diabetes Mellitus, Hashimoto's Thyroiditis			1						1	Lymphadenopathy	FLU3~PFIZER\WYETH~4008179~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163049	12/04/2000	TX	63.0	63		F	11/27/2000	Positive redness to injection site and mildly warm to touch.				Y					Y	11/19/2000	11/21/2000	2		PVT	PVT		NONE	UNK			1						1	Injection site erythema; Injection site warmth	FLU3~MEDEVA PHARMA, LTD.~E701601A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0163050	12/04/2000	GA	48.0	48		M	11/13/2000	Post vax, intense, generalized pruritus, lip swelling; pruritus worse over face and scalp.									U	11/10/2000	11/10/2000	0		UNK	UNK			Allergy to PCN, ASA, tetracycline, Ultram, codeine, Relafen, Biaxin, Vicodin, Vistaril, Demerol, Valium, Tegretol, Elavil, Advil, Darvon, Darvocet, Percocet, Vioxx.			1						1	Hypersensitivity; Pruritus; Swelling face	FLU3~AVENTIS PASTEUR~U0406AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163000	12/05/2000	IL	44.0	44		F	11/14/2000	On 10/27/00, pt presented to ER with complaint of non-radiating chest pain and numbness of fingers and toes. Discharged after 23 hours observation. To follow-up with her own physician. On 11/2/00, admitted to hospital for progressive worsening weakness, starting from the lower extremities to the trunk and upper chest. R/o Guillain-Barre. The follow-up reports states that the pt had similar experience in 1999 after her first exposure to flu shot.			Y		Y				Y	09/16/2000	10/23/2000	37	CMV AB-1.66; EBV-Igm-<0.91; EBV-IgG-1.48; EBV CWSIO IgG->3.0; CSF-culture neg after 4 sats; WBC-2/cm; RMN-2; Glucose-88; Protein-67	PVT	PVT	Accutane	NONE	NONE			1						1	Asthenia; Chest pain; Guillain-Barre syndrome; Hypoaesthesia	FLU3~AVENTIS PASTEUR~V0334AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0163001	12/05/2000	WV	73.0	73		F	11/22/2000	The pt experienced general flue like illness associated with an outbreak of cold sores on lips and nose.			Y						Y	10/31/2000	11/01/2000	1	Sed rate - 95	PUB	PUB	Accupril	NONE	degenerative joint disease		WV0010	1						1	Herpes simplex; Influenza; Red blood cell sedimentation rate increased	FLU3~AVENTIS PASTEUR~U0406AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~469133~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Life Threatening	Influenza
0163052	12/05/2000	UT	60.0	60		M	12/01/2000	A nurse reported that a 60 year old male received an injection of Flu Shield (2000-2001) on 11/27/00 and subsequently, developed chest pain and arm pain. He called his family physician who advised him to call 911. This event is considered Medically Important.									U	11/27/2000	11/27/2000	0	UNK	PUB	OTH	UNK	NONE	UNK		HQ4216729NOV2000	1						1	Chest pain; Pain	FLU3~PFIZER\WYETH~4008183~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163053	12/05/2000	MI	6.0	5		F		Post vax, the pt developed severe pain at injection site, could not walk the next day.									Y	11/14/2000	11/14/2000	0	NONE	PVT	PVT		NONE	NONE			1						1	Difficulty in walking; Injection site pain	FLU3~AVENTIS PASTEUR~U0414BB~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~474938~1~IM~LL~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0163059	12/05/2000	AK	26.0	26		F	11/15/2000	4cm indurated, erythematous area at site of injection.									Y	11/13/2000	11/13/2000	0		PVT	OTH	Tri-Levlen	NONE	Allergy to penicillin/Augmentin		AK200037	1						1	Injection site erythema; Injection site induration	FLU3~PFIZER\WYETH~4008171~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163060	12/05/2000	AK	53.0	53		F	11/21/2000	8cm X 6cm red area on left deltoid at site of influenza injection with fever 1st and 2nd day.									Y	11/13/2000	11/14/2000	1	NONE	PVT	OTH	HRT, Ca CO3	NONE	Allergy to codeine and morphine.		AK200036	1						1	Injection site erythema; Pyrexia	FLU3~PFIZER\WYETH~4008171~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163061	12/05/2000	NY	78.0	79		F	11/16/2000	On 11/5/00, complained of sore throat with no temperature or chest discomfort. On 11/6/00, complained of hip discomfort, unable to place weight on leg (1998 had a hip replacement). Had generalized aches and discomfort x 7 days. MD dx-flu disease on 11/7/00.				Y					Y	11/02/2000	11/05/2000	3		PUB	PUB		NONE	Arthritis		NYS20019	1						1	Abasia; Arthralgia; Influenza; Pain; Pharyngolaryngeal pain	FLU3~MEDEVA PHARMA, LTD.~E64470HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0163063	12/05/2000	NY	76.0	76		F	10/31/2000	Onset of right arm soreness, 4 hours, post vax of pneumococcal vaccine. Progressed to right arm, swelling and malaise, chills and feverish. Saw own MD, 2 days, post vax, and treated with amoxicillin. Fully recovered by 10/25/00.				Y					Y	10/17/2000	10/17/2000	0	NONE	PUB	PUB	Prozosin, aspirin	NONE	Hypertension		NY20017	1						1	Injection site pain; Injection site swelling; Malaise; Pyrexia	FLU3~AVENTIS PASTEUR~U0333AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~468140~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0163085	12/05/2000	TX	65.0	65		F	10/24/2000	On 10/20/00 at 08:00, had numbness to left side of face and jaw. At 11:00, had numbness to left lower lip. MD stated it was a local reaction.				Y					Y	10/19/2000	10/20/2000	1		PUB	PVT		NONE			TX00136	1						1	Hypoaesthesia oral	FLU3~MEDEVA PHARMA, LTD.~E66350HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0163097	12/05/2000	IN	6.0	6		M	11/28/2000	3 days of swelling and onset of rash; 5cm X 7cm erythematous area adjacent to 2cm X 5cm erythematous area surrounding darkened injection site. No induration, warmth or signs of infection. Treated with Benadryl for itching.				Y					Y	11/20/2000	11/20/2000	0	NONE	PVT	PVT	NONE	NONE	Inverted chromosome 15, FTT, Developmental delay			1						1	Injection site erythema; Injection site swelling; Pruritus; Rash; Skin discolouration	FLU3~PFIZER\WYETH~4008173~4~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0163100	12/05/2000	MO	43.0	43		F	11/09/2000	Post vax, pt complained of itchy, raised and reddened area coming up on opposite arm that evening (late) and then again the next day. The next day, got raised areas on left arm but was never any redness or raised area or increased pain at injection site. No problems with dyspnea or throat. Did take po Benadryl X 2 with relief. Client phoned physician. No fever, nausea or vomiting.									Y	10/30/2000	10/30/2000	0		PUB	PUB	Avonex		Multiple Sclerosis		MO2000083	1						1	Pruritus; Rash erythematous	FLU3~MEDEVA PHARMA, LTD.~E59270GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0163104	12/05/2000	MT	41.0	41		F	12/01/2000	Post vax, at 16:00, eyes watering and light cough noted by pt. Took Benadryl and symptoms were relieved some. On 11/29/00 at 08:00, had facial swelling, lips and tongue were tingling, no SOB. Took 50mg of Benadryl at home with good results. Started on Prednisone 20mg 2D X 4D and Claritin 10mg QD X 2-3 months, Pepcid 20mg QD X 8D.				Y					Y	11/27/2000	11/27/2000	0		PUB	PVT	Premarin, Flovent	NONE	Allergy to PCN and Typhoid vaccine; (+) PPD in 1963; history of 3 anaphylaxis events.			1						1	Cough; Hypoaesthesia oral; Lacrimation increased; Swelling face	FLU3~AVENTIS PASTEUR~U0403AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163107	12/05/2000	OK	47.0	47		F	11/30/2000	Complaining of itching at site, lower left arm and face, 5 minutes, post vax. Given Benadryl 25mg po and repeated, 1 hour later. She went to see her doctor. Her husband picked her up from work and took her to the doctor.				Y					Y	11/30/2000	11/30/2000	0		OTH	UNK	Altace, Prednisone, Soma, Celebrex	NONE				1						1	Injection site reaction; Pruritus	FLU3~PFIZER\WYETH~4008180~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0163108	12/05/2000	NY	26.0	26		F	11/27/2000	Acute onset of SOB, fever 102 and chest pain within 24 hours.									Y	10/02/2000	10/02/2000	0	Chest x-ray neg. V/Q scan neg.	PVT	PUB	NONE	NONE	NONE			1						1	Chest pain; Dyspnoea; Pyrexia	FLU3~AVENTIS PASTEUR~U0334BA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163109	12/05/2000	NY	23.0	23		F	11/27/2000	Fever, chills and sore throat.									Y	10/25/2000	10/30/2000	5	NONE	PVT	PUB	NONE	NONE	Juvenile Rheumatoid Arthritis			1						1	Pharyngolaryngeal pain; Pyrexia	FLU3~AVENTIS PASTEUR~U0334BA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163116	12/05/2000	WI	65.0	65		F	11/16/2000	On 11/14/00, at 16:00, had pain, swelling and erythema at site of injection. On 11/15/00, had fever and myalgia in right arm early AM. On 11/15/00, also had swelling, inflammation, myalgia deltoid, tricep and bicep muscles in right arm. On 11/16/00, at 10:00, had swelling, inflammation and myalgia in right arm.									Y	11/14/2000	11/14/2000	0	NONE	PUB	PUB						1						1	Injection site erythema; Injection site inflammation; Injection site pain; Injection site swelling; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4008174~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0690K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0163117	12/05/2000	CT	70.0	70		F	11/14/2000	Approx. 2 days, post vax, pt noticed red spot near site of IZ. Two days later, she had full blown hives from head to toe. MD prescribed Benadryl. Saw MD on 11/13/00 and was given cortisone shot and 6 days of oral prednisone.				Y					Y	11/07/2000	11/09/2000	2		PUB	PUB	Verapamil	NONE	Allergy to antibiotics/anti-inflammatory			1						1	Injection site erythema; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E67330KA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0163118	12/05/2000	NY	66.0	66		F	11/28/2000	By 16:00, on the day of vaccine shots, right arm, which received the pneumonia shot, swelled twice it's size, was beet red, hot to touch and painful to move. Saw my doctor on 11/13/00 and he gave me Cipro antibiotic and Tylenol for pain and hot compresses. Saw me again on 11/17/00 to see that swelling went down. (Bacterial infection). Totally gone by 11/22/00.				Y					Y	11/11/2000	11/11/2000	0		PUB	UNK	Capoten, Lopressor, Premarin	NONE	High blood pressure			1						1	Bacterial infection; Hypokinesia; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0956K~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0163119	12/05/2000	OH	65.0	65		F	11/09/2000	Noticed right arm was sore in the night. In the AM of 11/7/00, arm was red at the injection site and to elbow. Also, was swollen, hot and painful. To Urgent Care for treatment with hydroxylzine HCI, Prednisone and diclofenac.				Y					Y	11/06/2000	11/07/2000	1		PUB	PUB	Premarin, Provera, Zyrtec, vitamins, Atacand	NONE	Allergies to tetanus, Prinivil, sulfa, Penicillin, erythromycin	Unspecified reaction~Td Adsorbed (no brand name)~~50.00~In Patient		1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~AVENTIS PASTEUR~U0406AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~459837~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0163128	12/05/2000	DE	70.0	70		F	11/20/2000	Client states My right arm began hurting 15 minutes after I received the shot. My right arm began swelling and throbbing within 3 hours after receiving the shot. Swelling occurred from my elbow to my shoulder, mid-shoulder. I had severe itching of my right arm and just under my breast area. I felt sick to my stomach 9 1/2 hours, after the shot. I had a fever of 102F by 03:00 on 11/15/00. I developed fever blisters in my nose, the next day. By Saturday morning, 11/18/00, my glands were swollen in my neck area.				Y					Y	11/14/2000	11/14/2000	0	NONE	PUB	PUB	NONE	NONE	NONE		DE0006	1						1	Blister; Injection site pain; Injection site swelling; Lymphadenopathy; Nausea; Pruritus; Pyrexia	FLU3~AVENTIS PASTEUR~U0403AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~469133~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0163130	12/05/2000	MA	67.0			M	11/24/2000	Sore throat, cough, cold, chills, legs pinching (?), etc-Started these [symptoms] after end of 2nd day (ie, 16th). [On the] 17, 18, 19 were highest and I have lA (?) of cough and head still present (11/24/00).									N	11/14/2000	11/16/2000	2		PUB	UNK	NONE	NONE	NONE			1						1	Chills; Cough; Headache; Pharyngolaryngeal pain	FLUX~UNKNOWN MANUFACTURER~~4~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0163132	12/05/2000	UT	35.0	35		M	12/03/2000	Hives and itching over abdomen about 1-2 hours, post vax. About 5 hours, post vax, pt had itchy eyes.				Y					Y	11/28/2000	11/28/2000	0	NONE	OTH	PUB	Advil	NONE	Had reaction to TD before, allergic to PCN.	Hives and itching~Td Adsorbed (no brand name)~~32.00~In Patient		1						1	Pruritus; Urticaria	FLU3~AVENTIS PASTEUR~U0422DA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163133	12/05/2000	UT	48.0	48		F	11/08/2000	Cellulitis to 20cm X 14cm on upper arm. Fever 102F with slight chills. Resolved on 5th day.									Y	10/16/2000	10/16/2000	0	NONE	PVT	PVT	Naprosyn		Allergy to PCN, cephalosporin			1						1	Cellulitis; Injection site reaction; Pyrexia	FLU3~AVENTIS PASTEUR~U0400AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~19580~2~IM~~HEP A (VAQTA)~1|PPV~MERCK & CO. INC.~0577K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0162664	12/06/2000	PA	71.0	71		M	12/01/2000	Post vax, the pt developed hives and itching on stomach, groin, neck, and arms. Pt was prescribed hydroxyzine.									Y	11/15/2000	11/16/2000	1		PUB	PUB	Zocor, Hytrin, Proscar		allergy to Co-Tylenol			1						2	Pruritus; Pruritus; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E59070GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~E59070GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0163155	12/06/2000	TX	38.0	38		F	11/30/2000	Approx. 15 minutes, post vax, she noted a metallic taste in her mouth and 5 minutes later, noted numbness in both lips; 15 minutes later, lips remained numb and then had numbness in nose. Numbness progressed up face and then a bright red body rash appeared with itching. She was given Benadryl with most of symptoms resolved. Later, was given Benadryl again. Temperature was 99F, P-68 and BP 150/86.				Y					N	11/30/2000	11/30/2000	0	NONE	PVT	OTH	Prozac, Bactrim	Eustachian Tube Dysfunction	Eustachian Tube Dysfunction			1						1	Dysgeusia; Erythema; Hypertension; Hypoaesthesia oral; Pruritus; Rash	FLU3~PFIZER\WYETH~4008182~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0163158	12/06/2000	NY	26.0	26		M	11/29/2000	The patient had erythema, possible cellulitis of the left upper arm. The patient developed this twelve hours after the injection and it progressed for 12 hours. The patient was treated with Keflex, it slowly resolved in 1 week; no residual problems.				Y					Y	11/21/2000	11/21/2000	0		MIL	PVT		NONE	NONE			1						1	Cellulitis; Injection site erythema; Injection site reaction	FLU3~PFIZER\WYETH~4008183~4~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~463729~1~IM~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0163159	12/06/2000	NY	60.0	60		F	11/29/2000	Pt developed erythema and possible cellulitis on left upper arm. Seen by physician the next day and was placed on Augmentin. Symptoms resolved in 24 hours. Continued course of antibiotics.				Y					Y	11/21/2000	11/21/2000	0		MIL	PVT		NONE	NONE			1						1	Cellulitis; Injection site erythema	FLU3~PFIZER\WYETH~4008183~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~463729~1~IM~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0163170	12/06/2000	NJ	53.0	54		F	11/27/2000	On 11/18/00, post vax, arm was sore. On 11/19/00 AM, pain in chest, also pressure for last 2 days PM, had excruciating pain in left side of face and head. On 11/20/00, pain in sinuses with yellow nasal discharge. On 11/21/00, sinus discomfort continued. Started on OTC cold capsules. Stated she is somewhat better. All this, as reported by pt on 11/27/00. Pt continued with daily activities on 11/18/00 through 11/21/00. Pt refused to seek medical treatments.									Y	11/18/2000	11/18/2000	0	NONE	PUB	PUB	NONE	NONE	NONE	Local reaction~Influenza (Seasonal) (no brand name)~1~52.00~In Patient		1						1	Chest pain; Headache; Injection site pain; Rhinorrhoea; Sinus congestion	FLU3~AVENTIS PASTEUR~U0408CA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163171	12/06/2000	CA	71.0	71		F	11/22/2000	Hot, redness and itchy at injection site. (Unknown vaccine information due to shots not administered by this facility; given at local veteran's hall.)									Y	11/16/2000	11/16/2000	0	NONE	OTH	UNK		NONE				1						1	Injection site erythema; Injection site warmth; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0163175	12/06/2000	GA	35.0	35		F		1 hour, post vax, noted palpitations, then 2-3 hours later, had nausea and vomiting and chills. No fever documented. Symptoms resolved 24 hours, post vax.									Y	11/02/2000	11/02/2000	0		OTH	PVT	NONE	NONE	NONE			1						1	Chills; Nausea; Palpitations; Vomiting	FLU3~AVENTIS PASTEUR~U0406AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163178	12/06/2000	NC	40.0	40		F	11/30/2000	Left arm soreness, difficulty lifting over head, swelling of lymph nodes, swelling of tissue under arm to rib cage and muscle aches.									Y	11/22/2000	11/23/2000	1		MIL	PVT	NONE	NONE				1						1	Hypokinesia; Injection site pain; Lymphadenopathy; Myalgia	FLU3~PFIZER\WYETH~4008180~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163180	12/06/2000	IL	80.0	79		F	12/05/2000	Soreness at site for 4 days, post vax. Approx. 7 to 10 days, post vax, had episode of flashing light in left eye X several seconds, then experienced dizziness while sitting at a movie theater. Same thing happened 12/1/00, while at luncheon. On 12/3/00, was in the care, when became dizzy; drove to a fire station and saw paramedics. BP was 220/100. Evaluated at hospital and released.				Y					Y	11/03/2000	11/10/2000	7	CT, EKG, and lab tests-all wnl per pt, who saw her doctor on 12/4/00. Will have MRI of head.	PUB	PVT	Diachlor, ASA	NONE	Hypertension; had CABG in February, 1999			1						1	Dizziness; Hypertension; Injection site pain; Photophobia	FLU3~AVENTIS PASTEUR~U0410AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163182	12/06/2000	OK	53.0	53		M	11/29/2000	Itching and small hive approx. 5mm at injection site, 15 minutes, post vax.									Y	11/28/2000	11/28/2000	0		OTH	OTH	Wellbutrin	NONE				1						1	Injection site reaction; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4008180~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163190	12/06/2000	IA	45.0			F	12/01/2000	30 minutes, post vax, tetany noted with severe pain, lasting 12 hours; intermittent tetany still remains with pain in left deltoid and radiates to hand and at times, to left clavicle, up left side of neck. Condition remains sporadic to this date.				Y					N	10/18/2000			11/1/00 PMD referred for physical therapy, received 1 week with no relief. 11/14/00,after 2nd doctor visit, referred to orthopedic surgeon and on 11/22/00 he took X-ray of left shoulder. No additional treatment. Have neurosurgeon appt on 12/20/00.	UNK	UNK	Vioxx, Celebrex, Flexeril					1						1	Myalgia; Neck pain; Tetany	FLU3~AVENTIS PASTEUR~U0399AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163464	12/08/2000	WA	30.0	30		F	12/06/2000	A 29 year old female received Flu Shield (2000-2001) vaccine on 11/30/00 and several minutes later, developed chest tightness and difficulty breathing. She then developed a rash on her face, arms and chest and her throat started swelling shut. The pt began to hallucinate. Her blood pressure was elevated, her pulse rate was 116 and pulse oximetry was 'normal'. She was treated with epinephrine; however, her symptoms persisted. The pt was administered intravenous methylprednisolone sodium succinate and diphenhydramine. She recovered and went home. Within 3 hours, the pt called the physician's office and reported that she was experiencing chest tightness and shortness of breath. She returned to the office and her blood pressure was elevated. Pulse oximetry was still 'normal'. The pt then developed nausea and began vomiting. She was treated with IV methylprednisolone sodium succinate and an albuterol nebulizer treatment. That evening, she was admitted to the ICU and experienced 2 more episodes of chest tightness and not being able to breathe. Follow up information received 1/29/01 indicated that this patient recovered.					Y				Y	11/30/2000	11/30/2000	0	Oxygen saturation; nml X2	PVT	PVT	Tuberculin Pasteur; Xanax	NONE	UNK		HQ4392704DEC2000	1						1	Chest discomfort; Dyspnoea; Hallucination; Heart rate increased; Hypertension; Nausea; Pharyngeal oedema; Rash; Vomiting	FLU3~PFIZER\WYETH~4008183~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0163477	12/08/2000	MA	7.0	7		M	10/28/2000	The pt experienced erythema and swelling approximately 5 cm at the site of injection. The pt also experienced a fever, headache, vomiting after 24 hour post vax.  Follow up on 01/16/2001: Call to reporter about missing data, LM w/mgr.  Nurse will return call.  Call back indicates this was not Prevnar but Pnu-Immune 23.  The left leg site of the Pnu-Immune vaccination was involved.  Child had recently completed a course of Ceftin.  There is no history of vaccination adverse events, no other vaccination in the 4 months prior.  Follow up complete.									Y	10/25/2000	10/26/2000	1		PVT	PUB			mitochondria disorder			1						1	Headache; Injection site erythema; Injection site oedema; Pyrexia; Vomiting	FLU3~AVENTIS PASTEUR~U0346AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466444~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0163480	12/08/2000	MT	75.0	75		M	12/01/2000	The pt experienced facial weakness and was dx with Bell's Palsy.				Y					N	11/17/2000	11/27/2000	10	NONE	PVT	PVT	Verapamil, Glyburide, Lanoxin	NONE	NIDDM, HTN, drug allergy			1						1	Facial palsy; Muscular weakness	FLU3~PFIZER\WYETH~4008185~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0163482	12/08/2000	NJ	65.0	65		F	11/08/2000	Immediately following vax, the pt experienced immediate swelling surrounded by small blisters. MD diagnosed as a local reaction. Ice pack applied to injection site. Blood pressure and pulse monitored for 15 minutes, both remained stable. Pt denied symptoms of pain or itching. No respiratory distress observed.									Y	11/08/2000	11/08/2000	0	NONE	PUB	PUB	UNK	NONE	UNK		NJ200023	1						1	Blister; Injection site oedema	FLU3~AVENTIS PASTEUR~U0409AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0045J~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0163483	12/08/2000	IL	64.0	64		F	11/14/2000	The pt felt heart fluttering about 9:00 am for a short period. Went to bed, Ok until AM. Upon waking, the pt experienced sudden onset of extreme dizziness and emesis. Went to the MD. Given IV to hydrate.				Y					Y	11/06/2000	11/06/2000	0		PUB	PUB	NONE	NONE	occasional vertigo		IL00063	1						1	Cardiac disorder; Dizziness; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E64330HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0163486	12/08/2000	UT	70.0	70		F	11/07/2000	Itching, hot to touch on left arm with bruise and swelling the size of pt's fist/hand. Worse last night; seems to be getting better.									Y	11/06/2000	11/06/2000	0		PUB	UNK		NONE	NONE			1						1	Contusion; Hypersensitivity; Injection site swelling; Injection site warmth; Pruritus	FLU3~AVENTIS PASTEUR~U0417AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0690K~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0163487	12/08/2000	MA	58.0	58		F	12/01/2000	Pt reported being nauseous and light-headed. BP remained 132/78, soon after she stated she felt a lot better and shortly thereafter, she stated she was ok. On 12/2/00 per telephone conversation with pt, she stated she is fine.									Y	12/01/2000	12/01/2000	0	BP-132/78	OTH	PVT			Hep-C			1						1	Dizziness; Hypertension; Nausea	FLU3~PFIZER\WYETH~4008192~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163488	12/08/2000	WI	66.0	65		M	11/28/2000	Post vax, the pt had a temperature of 101.6. Injection site was very painful with decreased range of motion. Took portion of meperidine tablet. He then developed hot/cold flashes and took ibuprofen.									Y	11/27/2000	11/27/2000	0		PUB	UNK		NONE				1						1	Hot flush; Hypokinesia; Injection site pain; Pyrexia	FLU3~PFIZER\WYETH~4008179~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0690K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0163489	12/08/2000	CA	36.0	36		F	12/04/2000	Hives, 20 minutes, post vax. Employee took Benadryl 50mg, repeated that night. In the AM, employee went to her doctor as she was not better. Her doctor gave her Solu-Medrol IM, as her lips were swollen and 40 minutes later, employee reported chest pain, shortness of breath. Employee was given an Epi IVP.				Y					Y	11/27/2000	11/27/2000	0		OTH	PUB		NONE	NONE			1						1	Chest pain; Dyspnoea; Swelling face; Urticaria; Face oedema; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E71810LA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~E71810LA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0163494	12/08/2000	ID	66.0	66		F	11/08/2000	Swelling left hand with red streak radiating up wrist towards elbow. Treated in ER with splint, IV Heplock, antibiotic therapy X 3 days, then oral antibiotic.				Y					Y	10/27/2000	10/31/2000	4	NONE	PUB	OTH		NONE	Allergy to Demerol		ID00050	1						1	Cellulitis; Swelling	FLU3~AVENTIS PASTEUR~U0398AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163502	12/08/2000	GA	66.0	66		F	11/09/2000	On 11/8/00, had redness, swelling and soreness at site on right arm down to elbow. On 11/9/00 at 09:00, puffiness going down but little red and some swelling below elbow.									U	11/06/2000	11/08/2000	2		PUB	PUB		NONE				1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~MEDEVA PHARMA, LTD.~E65600HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0945K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0163503	12/08/2000	LA	36.0	36		F	11/20/2000	On 11/15/00, states she has been out of work all week due to soreness and swelling in arm. Visited private physician, who stated she had cellulitis in right arm.				Y					Y	11/13/2000	11/14/2000	1		PUB	PUB		NONE				1						1	Cellulitis; Injection site pain; Injection site reaction; Injection site swelling	FLU3~MEDEVA PHARMA, LTD.~E65600HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0945E~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0163504	12/08/2000	GA	53.0	53		F	11/16/2000	On 11/15/00, states not able to get out of bed. Aching with fever 99F-101F. Right arm swollen, coughing. On 11/16/00, office visit to doctor, who stated it was an allergic reaction to pneumonia shot. Red almost to elbow. Back and chest hurting but the doctor didn't hear anything in chest. Rx'd antihistamine and Advil with bed rest.				Y					Y	11/13/2000	11/14/2000	1		PUB	PUB		NONE				1						1	Back pain; Chest pain; Cough; Injection site erythema; Injection site swelling; Pain; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E65600HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0945K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0163506	12/11/2000	GA	71.0	71		M	11/22/2000	The pt received the flu shot on 11/21/00 without complications. The pt was found ill at home by his son and subsequently died at 5:00pm that same day.	Y	11/21/2000							N	11/21/2000	11/21/2000	0		PUB	PUB	UNK	NONE	CAD		GA00123	1						1	Unevaluable event	FLU3~AVENTIS PASTEUR~40422CA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0163507	12/11/2000	MA	45.0	45		F	12/04/2000	Approximately 3 hours post vax, the pt experienced respiratory symptoms (asthma like) over the next several hours which progressed systemically, severe headache, nausea, vomiting, chills, fever of 102. Treated with Tylenol, Benadryl and ventolin inhaler.			Y						Y	11/29/2000	11/29/2000	0		MIL	PUB		NONE				1						1	Asthma; Headache; Nausea; Pyrexia; Respiratory disorder; Vomiting	FLU3~AVENTIS PASTEUR~U0443AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0163512	12/11/2000	WI	41.0	41		F	12/01/2000	Received Flu vaccine on 11/13/00. On 11/14/00, developed numbness and tingling in bilateral feet, increased symptoms up both legs, feeling of heaviness and numbness and pain with difficulty ambulating. Denies any upper extremity symptoms. No SOB. IVIG 27gh IV X 5 days. Dx: GBS. Discharged on 11/28/2000; 60 day follow up states the pt still has residual leg weakness.					Y	5			U	11/13/2000	11/14/2000	1	MRI-neg;CSF culture-neg; CSF IgG-1.47, CSF electrophoreses-oligoclonal bands present	PVT	PVT	Tenormin, Premarin, Singulair, previous steroid use.		Mitral valve prolapse, mild asthma, recent cataracts			1						1	CSF test abnormal; Difficulty in walking; Guillain-Barre syndrome; Muscular weakness; Pain; Paraesthesia	FLU3~AVENTIS PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0163513	12/11/2000	WI	21.0	21		M	12/01/2000	Received flu vaccine on 11/22/00. Complained of chills, fever, night sweats, nausea and vomiting and fatigue on 11/24/00. On 11/27/00, had 10 lb weight loss, with increasing symptoms including diarrhea. Admitted to hospital on 11/27/00. Severe anemia. Pt was transferred to another facility.			Y		Y	5			U	11/22/2000	11/23/2000	1	LDH >5000; WBC-21.2; Increased liver enzymes; Increased Protein-19.6; Combs test- 4+ positive; HCT-31	PVT	PVT	Insulin		ITP and Type I Diabetes Mellitus			1						1	Anaemia; Blood lactate dehydrogenase increased; Coombs positive haemolytic anaemia; Diarrhoea; Fatigue; Hepatic enzyme abnormal; Laboratory test abnormal; Nausea; Night sweats; Pyrexia; Vomiting; Weight decreased; White blood cell count increased	FLU3~AVENTIS PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0163537	12/11/2000	IA	45.0			F	12/01/2000	30 minutes, post vax, tetany noted with severe pain, lasting 12 hours; intermittent tetany remains with pain left deltoid, radiates to hand and at times to left clavicle, up left side of neck. Condition remains sporadic to this date.				Y					N	10/18/2000	10/18/2000	0	11/1/00, saw family doctor and was referred to physical therapy. Received this for 1 week with no relief. Had a 2nd doctor visit on 11/14/00, and was referred to orthopedic surgeon. Saw him on 11/22/00 and had X-ray of left shoulder with no additional treatment. Neurosurgeon appt for 12/20/00.	UNK	UNK	Vioxx, Celebrex, Flexeril					1						1	Myalgia; Neck pain; Tetany	FLU3~AVENTIS PASTEUR~U0399AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163538	12/11/2000	IN	42.0	42		F	11/02/2000	Tingling in forearm, radiating to wrist with bruise on mid-forearm; 30 minutes later, noticed a red rash. Examined by Health Care; spot dark; treat with ice?				Y					Y	11/01/2000	11/01/2000	0		OTH	PVT		NONE	Allergy to morphine			1						1	Contusion; Erythema; Paraesthesia; Rash; Skin discolouration	FLU3~AVENTIS PASTEUR~U0399BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163540	12/11/2000	NM	70.0	70		F	11/22/2000	One day post vax, pt experienced puffiness of left arm, pinkness at injection site and low grade fever onset.									Y	11/13/2000	11/14/2000	1	NONE	PVT	OTH	verapamil, Provera, Premarin, Paxil, Questran, ASA, lorazepam	NONE	rosacea; depression; hypercholesterolemia			1						1	Injection site hypersensitivity; Injection site oedema; Pyrexia; Skin discolouration	FLU3~PFIZER\WYETH~4008173~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0944K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0163542	12/11/2000	MO	48.0	48		F	11/30/2000	Per pt; on 10/26/00, approx. 16:30, pt started to feel funny and not feeling well. She napped on the bus ride home and woke up with chills. After getting home, pt rested 3 hours and all of a sudden she had profuse sinus drainage, runny nose and eyes. Pt took 25mg of Benadryl. At approx. 19:30, pt had an upset stomach and took (4) papaya enzymes and 1 Pepcid. Pt reports she got very hot and itchy all over. Hives appeared and became patches on inner forearms, chest, stomach, back, buttocks (upper ext) and scalp itching and continued to become more intense. She developed instant throat pain and felt her throat closing and had trouble breathing. Called 911 and EMS arrived at pt's home and IV with Benadryl and O2 were given. Transported to hospital and observed for 2-3 hours. Dx: severe reaction to something. Rx: Prednisone, Zantac and Atarax. Epi-pen prescribed to carry at all times. Pt informed RN on 10/30/00, that she had swelling on forehead, upper and lower eyelids (especially right side) since Saturday 10/28/00. Pt contacted PMD and was prescribed Tavist-D OTC and within 24 hours, swelling was gone. Pt has had no other reaction since then.				Y					Y	10/26/2000	10/26/2000	0	NONE	OTH	OTH	Toprol	NONE	Seasonal allergies to pollen, ragweed and hypertension.			1						1	Chills; Dyspnoea; Hot flush; Hypersensitivity; Lacrimation increased; Malaise; Pharyngolaryngeal pain; Pruritus; Rhinorrhoea; Stomach discomfort; Swelling face; Throat tightness; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E64500HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0163544	12/11/2000	TN	77.0	77		F	11/27/2000	On 11/17/00, the pt complained of itching of her left arm, at the lower deltoid and at which time, she noted a red, raised area approx. 7cm in diameter with little red bumps on it. It was warm to touch. She saw a physician on 11/18/00 and was treated with an anti-inflammatory shot and a pill. She was given a prescription for a steroid nose pack. The pt was not given an actual dx, but she states that she assumes the physician must have thought it was the TD injection, as they did not tell her that it wasn't the TD injection. On 11/27/00, follow-up telephone call with the pt, she states the local symptoms have resolved.				Y					Y	11/08/2000	11/17/2000	9		PUB	PUB	This is the pt's spelling Kolosapam at night to aid sleep.	NONE	Feet get numb		TN00046	1						1	Injection site swelling; Injection site warmth; Pruritus; Rash erythematous	FLU3~MEDEVA PHARMA, LTD.~E67950KA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~CONNAUGHT LABORATORIES~U0194AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0163548	12/11/2000	GA	46.0	45		F	11/29/2000	Pt developed Cellulitis on left arm from shoulder to elbow.				Y					Y	11/14/2000	11/15/2000	1	NONE	PUB	PUB		NONE	NONE		GA00137	1						1	Cellulitis	FLU3~PFIZER\WYETH~4008174~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0690K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0163552	12/11/2000	GA	60.0	60		F	11/16/2000	Received flu vaccine on Monday at 14:15, by that evening, the site had become reddened and hot to touch. By morning, it was grapefruit sized, reddened area, hot to touch.									Y	11/13/2000	11/13/2000	0	NONE	PUB	PUB	Monopril	NONE	Allergy to Comtrex.		GA00133	1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~PFIZER\WYETH~4008174~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163555	12/11/2000	GA	75.0	75		F	11/09/2000	On 11/6/00, returned to clinic with swelling of right arm and itching around swollen area. Swelling measured 4 X 5 with mild erythema around outer edge of swelling. No problems breathing. Client to take OTC Benadryl 50mg every 6 hours and Tylenol every 4 hours and to put ice compresses to site. On 11/7/00, swelling increased up to 8 X 9. No itching. Swelling extended to shoulder and elbow. Was seen in clinic and told to continue conservative measures and return if it persists. On 11/8/00, client returned with swelling extended to below elbow with erythematous areas at elbow. Enter upper right arm was warm to touch. Temperature was 97.5F. Denies any fever or chills or difficulty breathing. Stated area was itching again particularly around the elbow area. Nurse consulted with doctor. Pt is to continue conservative measures and use topical OTC Cortaid type cream for itching. If fever and/or chills develop to go to ER. On 11/9/00, client returned and swelling and redness was improved. Still swollen at elbow with pinkness noted. Client to continue with current treatment.									Y	11/06/2000	11/06/2000	0		PUB	PUB		NONE	NONE		GA00129	1						1	Feeling hot; Injection site erythema; Injection site swelling; Injection site warmth; Pruritus	FLU3~MEDEVA PHARMA, LTD.~E61750GA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0690K~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0163558	12/11/2000	MA	70.0	70		F	10/23/2000	On 10/20/00 at 05:00, had upset stomach, nausea and vomiting with severe headache and shakes. No temperature. Phoned physician and he prescribed something for nausea. On 10/20/00 at 17:00, doctor took her to hospital and was seen in ER. Gave her orange juice. Never had temperature. BP increased to 177/60. On 10/23/00, feels weak but retaining food.				Y					Y	10/19/2000	10/20/2000	1	Glucose capillary test-161 after glass of orange juice	PVT	PUB	Klonopin, Thyroid pill, Humulin Insulin	NONE	Cardiac palpitations; under active thyroid, Diabetes Mellitus			1						1	Asthenia; Headache; Hypertension; Nausea; Stomach discomfort; Tremor; Vomiting	FLU3~AVENTIS PASTEUR~U0441AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163559	12/11/2000	PA	58.0	58		M	12/08/2000	Post vax, the pt developed rash and redness, started itching on 12/6/00. Applied ointment on 12/7/00.									U	12/05/2000	12/06/2000	1		OTH	UNK						1						1	Erythema; Pruritus; Rash	FLU3~PFIZER\WYETH~4008180~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163561	12/11/2000	TX	42.0	42		F	12/07/2000	Developed generalized body rash, post vax.				Y					Y	11/07/2000	11/08/2000	1		PUB	OTH	INH, B6	NONE	NONE			1						1	Rash	FLU3~AVENTIS PASTEUR~U0422AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163562	12/11/2000	TX	40.0	40		F	12/07/2000	Developed swelling of left side of neck and lymph system.				Y					Y	11/08/2000	11/09/2000	1	Blood work CBC; Thyroid test	PUB	OTH	BC pills	NONE	NONE	Unspecified reaction~Tetanus Toxoid (no brand name)~~39.00~In Patient		1						1	Lymphadenopathy	FLU3~AVENTIS PASTEUR~U0422AA~6~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163563	12/11/2000	PA	49.0	49		F	12/01/2000	Area hot, swollen and spreading down to elbow; cold sweats; temperature 97F; dizzy; BP 145/92; nausea; burning eyes and myalgias.									Y	10/09/2000	10/09/2000	0		PVT	UNK		Constipation; (mild inclusion cyst, chest wall)				1						1	Eye pain; Hyperhidrosis; Hypertension; Hypothermia; Injection site swelling; Injection site warmth; Myalgia; Nausea	FLU3~AVENTIS PASTEUR~U0346AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~470590~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0163564	12/11/2000	MO	0.6	0	.6	F	11/29/2000	Pt had a grand mal seizure apparently unassociated with fever, 12 hours, post vax. She had no respiratory compromise and recovered well, but was seen in the ER.				Y					Y	11/22/2000	11/23/2000	1	CT head; electrolytes; Ca; BUN, Creat; Mg; Phos	PVT	PVT	NONE	NONE	Tracheostomy for paralysis of vocal cords at birth.			1						1	Grand mal convulsion	FLU3~AVENTIS PASTEUR~U0410AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163566	12/11/2000	PA	59.0	59		M	12/04/2000	Fever, nausea (severe), chills, aches/pains, dry mouth. Took Tylenol/aspirin for 2 1/2 days. Also had stomach pain.									Y	12/01/2000	12/02/2000	1	NONE	PVT	PVT	Daypro	NONE	Fibromyalgia; lower back pain (chronic)			1						1	Abdominal pain upper; Dry mouth; Nausea; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0163568	12/11/2000	MS	50.0	50		F	12/01/2000	Non-itching, red rash with burning sensation over 70% of body, back, trunk, inside of arms, inner thighs and some whelps formed.				Y					Y	11/28/2000	11/29/2000	1		OTH	PVT		NONE	Sinus surgery in 9/00.			1						1	Erythema; Rash; Urticaria	FLU3~AVENTIS PASTEUR~U0414BB~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163569	12/11/2000	CA	81.0	81		F	12/06/2000	Pt complained of itching on left arm, shortly after vaccine. She had more itching through the night. Did not tell nurse about the itching on 12/5/00. Came in to clinic the following morning. Left side of face was swollen. Had hives on upper extremities. BP 130/60; P-76. Gave Benadryl and prednisone.									Y	12/05/2000	12/05/2000	0	NONE	PVT	PVT	Motrin	Arthritis	Arthritis, anemia, HTN, diverticulitis			1						1	Face oedema; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4008190~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163570	12/11/2000	AZ	61.0	61		F	12/08/2000	5.5cm erythematous induration with pain and edema.									U	12/06/2000	12/07/2000	1	NONE	PVT	PVT	Several	NONE				1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site pain	FLU3~AVENTIS PASTEUR~U0446AA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163571	12/11/2000	SC	65.0	65		F	11/30/2000	Right lower arm swollen, tender to touch, feverish and reddened the next day, post vax. Client also complained of feeling dizzy and blacked out. Client to clinic on 11/30/00 with right lower arm area swollen, reddened and less tender to touch and less feverish. Client advised to apply cold compress to area and take Benadryl as needed.									Y	11/28/2000	11/29/2000	1	NONE	PUB	UNK	Aspirin	NONE	NONE		SC00070	1						1	Dizziness; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Loss of consciousness	FLU3~AVENTIS PASTEUR~U0439DA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~469133~1~SC~RA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~U0266BA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0163572	12/11/2000	SC	58.0	57		M	11/20/2000	Left arm, at site of injection, with 3 X 3 reddened area, hot to touch, non-tender. No other symptoms or complaints stated. Event began 1 day, post vax. Referred client to PMD. Client was to see MD that afternoon.									Y	11/15/2000	11/16/2000	1	NONE	PUB	OTH	HTN medication	NONE	Allergy to penicillin		SC00069	1						1	Injection site erythema; Injection site warmth	FLU3~MEDEVA PHARMA, LTD.~E66350HA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~469133~1~IM~LA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~U0266BA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0163580	12/11/2000	AZ	71.0	71		F	12/01/2000	6 hours, post vax, the right deltoid became sore and was unable to lift arm. Applied ice, heat and took ibuprofen with some relief but states it is better today.									Y	11/28/2000	11/28/2000	0		PUB	OTH	Provera, Provical	NONE	NONE		AZ0032	1						1	Hypokinesia; Injection site pain	FLU3~PFIZER\WYETH~4008174~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0690K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0163581	12/11/2000	CO	68.0	68		M	12/04/2000	Macular-papular rash only on legs and forearms. States some itchiness approx. 36 hours, post vax. Denied any other signs or symptoms of illness or problems.									U	11/21/2000	11/22/2000	1		PUB	PUB		NONE	NONE			1						1	Pruritus; Rash maculo-papular	FLU3~PFIZER\WYETH~4008183~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163582	12/11/2000	TX	63.0	63		F	12/04/2000	Pain 30 minutes, post vax, with swelling and redness to site that night; worsening 2 days later. States she took Tylenol for pain and temperature of 99.9F. Also states she noted lumps on inside of bicep area. States feels better today (12/4/0) but symptoms are still there.									Y	11/30/2000	11/30/2000	0		PUB	PUB	NONE	NONE	NONE			1						1	Injection site erythema; Injection site mass; Injection site pain; Injection site swelling; Pyrexia	FLU3~PFIZER\WYETH~4008182~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~474936~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0163583	12/11/2000	NC	72.0	72		F	12/04/2000	Widespread hives which lasted almost 10 days. Began approx. 3 hours, post vax. Treated with Benadryl and cool compresses.									Y	10/30/2000	10/30/2000	0		PUB	UNK	UNK	NONE				1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~U0333AA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0163585	12/11/2000	KY	74.0	74		F	12/01/2000	I received my shot Monday in 11/27/00 at 13:30. I started with chills about 19:00 Monday night and I woke up about 03:00 vomiting and had diarrhea. I couldn't hold anything down until this afternoon. I had a little ginger ale. I called the doctor and he sent my promethazine which helped some. I still can't eat some food yet.									U	11/27/2000	11/27/2000	0		PVT	UNK		NONE	NONE			1						1	Chills; Decreased appetite; Diarrhoea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0163587	12/11/2000	FL	76.0	76		F	11/30/2000	Client states that on the evening of 11/14/00, around 17:30, she felt sick; about midnight she complained of backache, neck and arm aching. Called nurse hotline and was advised to take Tylenol, which she did. On 11/16/00, client states she felt light-headed and called her doctor, who was not in. She returned to the health dept where she got her shot. Examination of the right arm, indicated swelling, redness and warm to the touch from the middle of the upper arm to the elbow; and a small raised blister on the anterior right arm about 2 above the elbow which appeared to be an insect bite. IZ records indicate pneumococcal vaccine was administered in right deltoid. Health dept placed a call to client's doctor who was on vacation and was advised by their office to send client to walk-in clinic or the ER for follow-up. Client chose to go to walk-in clinic and was dx'd with cellulitis. On 11/20/00, client reports she received antibiotic shot on 11/16 and 11/17 and her arm is better although her right arm to the middle of her chest is still sensitive to touch.				Y					Y	11/14/2000	11/14/2000	0		PUB	OTH		UNK	UNK			1						1	Back pain; Cellulitis; Dizziness; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Malaise; Neck pain	FLU3~AVENTIS PASTEUR~U0405AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0690K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0163590	12/11/2000	GA	72.0	72		M	10/11/2000	Client states that on Wednesday evening on 10/4/00, post vax, he noticed that his left arm was hurting. He rolled up the sleeve of his shirt and saw that his arm was swollen at the site of injection. After 2 days, the site remained swollen and began to turn dark down to his elbow. On Monday, 10/9/00, he saw a doctor who informed him that the blood thinner that he is currently taking could have caused him to have a reaction to the flu shot and that it may take up to 2 weeks to clear up. No treatment was given at the time of doctor's visit. On 10/13/00, 17:30, called client to determine status. He states he did not think his MD would call him. Called his MD's answering service and was assured the doctor, on call, would call MD. On 10/16/00, 17:30, pt states doctor never called on Friday, but he did see a doctor today. He was told by this doctor, that the bleeding will stop and he agreed that the bruise had not gotten any larger. Pt states he is just fine.				Y					N	10/04/2000	10/04/2000	0		PUB	PUB	Blood thinner and several other medications	NONE	History of open heart surgery, gland problems, prostate removed		GA00125	1						1	Injection site haemorrhage; Injection site pain; Injection site swelling	FLU3~MEDEVA PHARMA, LTD.~E61750GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0163596	12/12/2000	AL	4.0	4		M	12/05/2000	The pt arrived at the medical center in full arrest. Grandmother had found him struggling for breath in bed. Death certificate received states cause of death: respiratory arrest due to cardiac arrest due to respiratory distress. Other significant conditions noted was a brain tumor.	Y	12/05/2000							N	12/04/2000	12/05/2000	1		PVT	PUB	Zyrtec, Cortef, DDAVP, Synthroid, Dimetapp, Ventolin	ROM, URI	Optic Glioma, Panhypopituitarism, GERD, Seizures			1						1	Cardiac arrest; Respiratory arrest	FLU3~AVENTIS PASTEUR~U0415AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0163607	12/12/2000	AL	60.0	60		F	11/28/2000	Shortness of breath and hospitalization within 30 hours, post vax. Developed chills, aches, etc. Reports subnormal temperature. Treated with IV's, steroids and antibiotics by pt history. Reaction to Flu shot.				Y	Y	6			Y	10/19/2000	10/20/2000	1		PUB	UNK	Accolate, Verapamil, albuterol, AeroBid, Atrovent, aspirin, Nitro Quick, Mylanta, Pepcid	NONE	Asthma, osteoporosis, 2 heart attacks, light stroke, hypertension, migraines, hiatal hernia, osteo-arthritis, allergy to codeine, Flexeril, sulfa drugs.		AL0017	1						1	Chills; Dyspnoea; Hypothermia; Pain	FLU3~MEDEVA PHARMA, LTD.~E67940KA~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0163626	12/12/2000	VA	72.0	72		F	12/06/2000	Pt received flu vax, some redness, approximately 2m, and warmth noted. Pt instructed to return if any increase. Minute increase in size of redness next day. Pt referred to physician who also gave him instructions to return if any increase in reaction.				Y					U	12/04/2000	12/05/2000	1	NONE	MIL	MIL		NONE	NONE			1						1	Feeling hot; Injection site hypersensitivity	FLU3~PFIZER\WYETH~4008210~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0163627	12/12/2000	MD	74.0	74		M		High fever, weakness, paleness, dizziness, aches from Thursday to Tuesday. Sought medical treatment and received prescription Z-Pak.				Y					Y	11/08/2000	11/19/2000	11		UNK	UNK						1						1	Asthenia; Dizziness; Pain; Pallor; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E68790KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0163628	12/12/2000	NY	32.0	32		F		Headache, nausea/vomiting, fever, myalgia within 45 minutes of receiving vax. Temperature increased to 101.3. She sought medical attention and received prescription for Tigan. Compazine was administered in the office. Symptoms resolved within 48 hours.				Y					Y	11/09/2000	11/09/2000	0	NONE	PVT	PVT	NONE	NONE	RSD (reflex sympathetic dystrophy)			1						1	Headache; Myalgia; Nausea; Pyrexia; Vomiting	FLU3~AVENTIS PASTEUR~U0333AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163629	12/12/2000	MS	85.0	85		F	12/05/2000	Received vax on Monday, Nov 27. Wednesday evening, started itching. Thursday morning, got red, flat rash all over body except feet. Dizzy also. Sought medical treatment and physician did not relate to flu shot.				Y					Y	11/27/2000	11/29/2000	2		PUB	PUB	diuretic, anti-anxiety medication	NONE	Shellfish allergy		MS00050	1						1	Dizziness; Pruritus; Rash	FLU3~PFIZER\WYETH~4008182~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0163630	12/12/2000	OH	53.0	53		F	12/06/2000	Two to 5 minutes post vax, whole left side arm, armpit, back to legs hurt, tingling, numb. Felt dizzy 1-2 hours later. Called physician and went to ER. Was given calming pill and sent home. Pt did put ice on arm at home. Has redness size of silver dollar and is still sore form shoulder to elbow.				Y					U	12/05/2000	12/05/2000	0		PUB	OTH	Prednisone	Asthma	Asthma, allergy to milk, horseradish, bees.			1						1	Back pain; Dizziness; Injection site hypersensitivity; Injection site pain; Pain; Paraesthesia	FLU3~AVENTIS PASTEUR~UO443AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163631	12/12/2000	CA	70.0	70		M	11/30/2000	Approximately 3 days post vax, this pt developed vomiting, chest congestion, fever to 101 degrees F, diarrhea, and myalgia. He consulted physician one week later on 11/13/00. He later developed a severe arthralgia and discoloration of both distal feet. Testing conducted yielded results consistent with polyarthralgia and vasculitis. Also mild anemia.				Y					N	11/01/2000	11/04/2000	3	Sedimentation rate elevated.	OTH	PVT			Allergy to erythromycin.			1						1	Anaemia; Arthralgia; Diarrhoea; Myalgia; Pyrexia; Red blood cell sedimentation rate increased; Skin discolouration; Upper respiratory tract infection; Vasculitis; Vomiting	FLU3~AVENTIS PASTEUR~U0336EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163632	12/12/2000	AR	35.0	35		F	12/08/2000	Received vax about 2 PM 12-7-00. AT about 8 PM, she had shortness of breath. At 9:30 chills, and then rapid heart beat. Ears were also hurting. Has head congestion today. Right eye is red.									U	12/07/2000	12/07/2000	0		PUB	UNK		NONE	NONE		AR0050	1						1	Chills; Dyspnoea; Ear pain; Heart rate increased; Nasal congestion; Ocular hyperaemia	FLU3~AVENTIS PASTEUR~U0447AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163633	12/12/2000	AR	26.0	26		F	12/08/2000	Left side of face slightly swollen.									Y	12/07/2000	12/07/2000	0		PUB	PUB	BCP	NONE	NONE		AR0049	1						1	Face oedema	FLU3~AVENTIS PASTEUR~U0447AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163634	12/12/2000	IL	99.0	99		F	11/27/2000	Client noticed rash and swelling on face (only) on 11/11/2000 at 2AM. The flu vax was administered on 11/08/2000 at 10AM. Client called physician's office and was told the 'rash was caused by the flu shot and client should not receive flu shot next year.'									Y	11/08/2000	11/11/2000	3		OTH	UNK		NONE			IL00066	1						1	Face oedema; Rash	FLU3~MEDEVA PHARMA, LTD.~E64300HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0163635	12/12/2000	CA	80.0	80		F	11/20/2000	Pt received a flu and pneumonia vax on 11/15/2000. Pt came in on 11/17 with red, swollen, hot right arm.				Y					U	11/15/2000	11/15/2000	0		OTH	OTH	Blood pressure medications	NONE				1						1	Erythema; Oedema peripheral	FLU3~MEDEVA PHARMA, LTD.~E64330HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~468136~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0163636	12/12/2000	WI	33.0	33		M	12/08/2000	Received vax at 09:30 AM. At 10:30AM, pt developed symptoms of shakiness, weakness, hot/cold sensation, slight shortness of breath, left upper arm discomfort. at 11:00 - 11:15. He was given Benadryl, 25mg IM. Full assessment conducted by physician.				Y					Y	12/08/2000	12/08/2000	0	NONE	PVT	PVT	Advil 200mg, 3 tabs at 7:30AM on 12/08/00	NONE	NONE			1						1	Asthenia; Dyspnoea; Feeling cold; Hot flush; Injection site pain; Tremor	FLU3~AVENTIS PASTEUR~U0399CA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163637	12/12/2000	AL				U		Purpura bilateral legs. Pt was given Medrol dose pack as treatment.				Y					U	12/08/2000			CBC and Ptt - nml	UNK	UNK						1						1	Purpura	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0163639	12/12/2000	GA	11.0	11		F	11/16/2000	Pt complained of soreness the next day. Vax given to left upper arm. Felt lump about the size of a half dollar. After 3 days, has reddened and soreness to area remains and fever.									U	11/13/2000	11/14/2000	1		PUB	PUB	Claritin Daily	NONE	Asthmatic		GA00132	1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Pain; Pyrexia	FLU3~PFIZER\WYETH~4008174~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~SMITHKLINE BEECHAM~5159A2~1~IM~RA~HEP B (ENGERIX-B)~1|PPV~MERCK & CO. INC.~1070K~1~~LA~PNEUMO (PNEUMOVAX)~1|VARCEL~MERCK & CO. INC.~0763K~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0163673	12/13/2000	CT	80.0	80		M	12/12/2000	Pt volunteer fireman, called out on evening of 12/1/00, was photographer. Wasn't feeling well. Vomited at the scene. Refused treatment by EMT's. Returned home, collapsed and EMT's were unable to resuscitate.	Y	12/01/2000							N	11/30/2000	12/01/2000	1	NONE	PUB	PUB					CT200006	1						1	Circulatory collapse; Feeling abnormal; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E59090GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0163680	12/13/2000	IL	19.0	19		M	12/04/2000	On 11/21/00, had viral infection and had taken Zithromax for 5 days. On 11/23/00, symptoms worsened. On 11/25/00, client felt weak and tired and had taken sleeping pills to rest that night. On 11/26/00, still ill with dizzy spells, vertigo and diplopia and nystagmus. Student returned to school on 11/27/00. On 11/28/00, dad picked up son from school and brought back home and then brought to hospital and admitted at 00:00 on 11/24/00. Treatment IV Ig on 11/28/00. Last treatment 12/3/00 and is still in the hospital Diagnosed with Guillain Barre syndrome				Y	Y	6			U	10/06/2000	11/26/2000	51	lumbar puncture - benign, spinal tap, MRI, MRA, CT Scan, STD testing, drug test	OTH	PVT	Zithromax		At age 4-5 had congenital brain murmur			1						1	Asthenia; Diplopia; Dizziness; Guillain-Barre syndrome; Nystagmus; Vertigo; Viral infection	FLU3~AVENTIS PASTEUR~U045AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0163697	12/13/2000	FL	35.0	35		F	12/12/2000	Pt experienced swelling and pain in right neck/shoulder area of arm where vax was administered.				Y					U	12/11/2000	12/12/2000	1		UNK	UNK		NONE	NONE			1						1	Injection site pain; Injection site swelling	FLU3~AVENTIS PASTEUR~U0439FA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163698	12/13/2000	IL	75.0	75		F	12/12/2000	Pt felt weak and dopey at dinner and awoke on the floor, incontinent of urine. Pt experienced slight headache and weakness that night. Pt was fully recovered within 48 hours later.									Y	12/07/2000	12/09/2000	2	NONE	OTH	PUB	NONE	sniffles	NONE			1						1	Asthenia; Dissociation; Headache; Urinary incontinence	FLUX~UNKNOWN MANUFACTURER~~7+~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0163699	12/13/2000	WA	5.0	5		M	11/20/2000	One day post vax pt complained of swelling, itching and discomfort in his left  arm.  Parent noted a fine papular rash and hot area around injection site. Pt treated with Benadryl and ice pack. Three days post vax pt was improving.  The left arm still edematous four days post vax. No respiratory difficulty noted.									Y	11/16/2000	11/17/2000	1		OTH	PUB	Albuterol	NONE	Asthma			1						1	Injection site pain; Injection site swelling; Injection site warmth; Pruritus; Rash papular	FLU3~AVENTIS PASTEUR~U0406AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163700	12/13/2000	IL	60.0	60		M	12/04/2000	Two days post vax pt developed erythematous macular eruption over his arms, legs and trunk. Pt was treated with Celestone 2cc IM, Claritin 10mg daily for two days. Pt stated rash was gone within two days.				Y					Y	10/19/2000	10/19/2000	0	NONE	PVT	PVT		NONE				1						1	Rash maculo-papular	FLU3~AVENTIS PASTEUR~U0399BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163701	12/13/2000	AZ	57.0	57		F	11/10/2000	Pt experienced upset stomach and vomiting.									Y	11/06/2000	11/07/2000	1		PUB	UNK		NONE				1						1	Stomach discomfort; Vomiting	FLU3~AVENTIS PASTEUR~U0422BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163702	12/13/2000	CA	59.0	59		F	12/04/2000	Pt developed 6cm-7cm area of erythema.  Pt states felt itchy immediately.									U	11/28/2000	11/29/2000	1	NONE	PUB	PVT		NONE	NONE			1						1	Injection site erythema; Pruritus	FLU3~PFIZER\WYETH~4008180~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163703	12/13/2000	ME	26.0	26		F	12/01/2000	Pt experienced numbness in left hand after  injection that lasted 24 hours.									N	11/28/2000	11/29/2000	1		PVT	PVT	NONE					1						1	Hypoaesthesia	FLU3~AVENTIS PASTEUR~U0346AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163704	12/13/2000	CO	42.0	42		F	11/27/2000	Pt experienced tingling, numbness on same side of body as flu shot that lasted 3 weeks. Pt developed red, hot lump at injection site 5 days. Tingling and numbness progress to bilateral full body at 3 weeks became Bells Palsy, right sided. Pt still being treated with steroids, symptoms persisting.				Y					N	11/01/2000	11/01/2000	0	CBC, CMP, MRI Brain	PVT	PVT	NONE	NONE	sulfa medications			1						1	Facial palsy; Hypoaesthesia; Injection site erythema; Injection site mass; Injection site warmth	FLU3~AVENTIS PASTEUR~U0399AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163705	12/13/2000	NE	36.0	36		F	12/01/2000	Pt describes receiving flu vax in one arm and pneumonia vax in other arm. Pt states flu hurt almost immediately post vax. Approximately 18:30, pain in arms was so severe that Motrin was ineffective. Pt complained of muscle cramps in legs that were never experienced prior to vax, fatigue even to stand, slept a lot, gasping for air a lot and low grade fever. Recovered as of 12/5/00.									Y	11/22/2000	11/22/2000	0	NONE	PUB	PVT	NONE	NONE	lost part of lung unknown reason at 7 years of ago			1						1	Dyspnoea; Fatigue; Injection site pain; Muscle spasms; Pyrexia; Somnolence	FLU3~PFIZER\WYETH~4008183~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~469908~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0163706	12/13/2000	WA	71.0	71		F		5 hours post vax pt developed a sudden and severe headache that lasted about one hour.  Pt had trouble focusing on anything, had a fast heart beat, and very high blood pressure.  Symptoms last approximately 6 hours.									Y	11/04/2000	11/04/2000	0	NONE	PVT	PVT	Vioxx, metoclopramide, Ortho-Est	NONE	dust allergy	Hives at injection site of 3~Influenza (Seasonal) (no brand name)~1~68.00~In Patient		1						1	Headache; Heart rate increased; Hypertension; Vision blurred	FLU3~AVENTIS PASTEUR~U0377AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163707	12/13/2000	CA	5.0	3		F	12/07/2000	Pt experienced varicella onset on 12/04/00.  This is to report chicken pox in previously vaccinated pt.				Y					N	10/22/1998	12/04/2000	774	NONE	PVT	PVT	NONE	NONE	asthma			1						1	Drug ineffective; Infection	FLU3~CONNAUGHT LABORATORIES~0983330~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1110H~1~IM~RL~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~1256H~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0163708	12/13/2000	KY	39.0	39		F		Pt developed half dollar sized lump on left arm deltoid, painful to touch - heat.									Y	12/06/2000	12/07/2000	1		PUB	UNK						1						1	Injection site mass; Injection site pain; Injection site warmth	FLU3~PFIZER\WYETH~4008193~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163709	12/13/2000	NC	37.0	37		F	12/05/2000	Within 6 hours post vax, pts arm turned red around injection site with swelling.  Within 2 days right arm swollen more with tenderness and redness under arm.  Pt treated with prednisone for emphysema and asthma.				Y					Y	12/01/2000	12/01/2000	0	NONE	PUB	PUB	NONE	NONE	asthma			1						1	Asthma; Emphysema; Injection site erythema; Injection site pain; Injection site swelling	FLU3~PFIZER\WYETH~4008180~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1159J~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0163710	12/13/2000	OK	52.0	52		F	12/06/2000	Pt stated that she developed a large lump about the size of a baseball on her arm and complained of itching.  Upon return to the clinic on 12/6/00, pt had a red circle at injection site about 50 mm in diameter.									Y	11/09/2000	11/10/2000	1	NONE	MIL	MIL	Insulin, Premarin, Calcium, multivitamins, lisinopril	IDDM, HTN, HRT	NONE			1						1	Injection site erythema; Injection site mass; Pruritus	FLU3~PFIZER\WYETH~4008209~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163711	12/13/2000	MT	34.0	34		F	12/06/2000	Pt complained of burning during vax administration and immediately after complained of unusual feeling and cramping of muscle (deltoid) 3 minutes post vax pt developed dime sized welt with vague respiratory complaints. Pt also complained of lightheadedness. Pt treated with Benadryl 25mg PO 10 minutes post vax and ice pack to area. Repeated Benadryl 25mg 40 minutes later.  Welt increased in size to 10 cm.									Y	11/10/2000	11/10/2000	0		OTH	PVT	NONE	NONE	dust, cats, seasonal allergies.			1						1	Dizziness; Feeling abnormal; Injection site pain; Muscle spasms; Respiratory disorder; Urticaria	FLU3~AVENTIS PASTEUR~U0423AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163751	12/14/2000	AZ	62.0	62		M	12/08/2000	I took the shot on Friday, 11/9/00, and on Saturday, 11/10/00, I got up to go to work at 11:15 and I was dizzy and had a bad headache, which lasted several days and still comes back sometimes in the morning when I awake. I had double vision, which is still with me. I was admitted to the hospital and had tests. 60 day follow-up states the pt's right eyeball is still sore to the touch. The pt has a tendency to cry when he gets emotions. The pt now has to the restroom during the night.					Y	4			N	11/09/2000	11/10/2000	1	2 MRI's; Spinal Tap and other tests.	PVT	OTH	Flovent inhaler; Serevent inhaler; Claritin pill	Asthma (just got over a bad attack)				1						1	Diplopia; Dizziness; Emotional disorder; Eye pain; Headache; Pollakiuria	FLU3~AVENTIS PASTEUR~40402BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0163758	12/14/2000		61.0	61		F	12/11/2000	On 12/8 and 12/9, the pt noticed slight shortness of breath. She went to ER on 12/10 and x-rays showed pulmonary edema bilaterally.				Y	Y				U	12/07/2000	12/08/2000	1		UNK	UNK			DM, chronic renal failure, HTN, allergies			1						1	Dyspnoea; Pulmonary oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0163759	12/14/2000	TN	22.0	22		F	12/13/2000	The pt developed a rash on the thighs and upper back with itching.									U	12/07/2000	12/08/2000	1		PVT	OTH	NONE	NONE	allergy to aspirin			1						1	Pruritus; Rash	FLU3~AVENTIS PASTEUR~U0434AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163760	12/14/2000	PA	50.0	50		F	12/06/2000	The pt experienced hives on the trunk of body, redness, itching, raised blotches, rash, approximately 12 hours post vax, Treated with hydrocortisone cream									Y	12/01/2000	12/04/2000	3		OTH	PVT	ibuprofen					1						1	Erythema; Pruritus; Rash; Rash macular; Urticaria	FLU3~AVENTIS PASTEUR~U0439BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163761	12/14/2000	CA	58.0	58		F	12/07/2000	The pt experienced dizziness, then got very hot, and nauseous, laid on the cool bathroom floor for 2 hours. Every time the pt stood up she would get dizzy/hot/nauseous again. This continued for about 8 hours then she felt a little better. Could not eat, but could drink water.									Y	12/06/2000	12/07/2000	1		OTH	OTH	valium, estrace	NONE	environmental allergies			1						1	Decreased appetite; Dizziness; Feeling hot; Nausea	FLU3~PFIZER\WYETH~4008197~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163762	12/14/2000	VT	9.0	9		M	12/13/2000	One day post vax, the pt developed hives on arms, legs, face trunk. Still has them one week later.				Y					N	12/05/2000	12/06/2000	1		PVT	UNK			reactive airway disease		VT00005	1						1	Urticaria	FLU3~PFIZER\WYETH~40085190~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0163763	12/14/2000	CA	56.0	56		M	12/05/2000	Following exercising, the pt became suddenly confused, felt like he was in a fog, loss of identity. The pt had no recent memory of conversations he had with his daughter or wife. The pt had difficulty writing NP after my name not knowing or questioning to myself if it was right. The pt was able to function and do his job. The symptoms cleared 6-7 hours later with full recall. The pt also complained that his neck hurt.				Y					U	11/28/2000	11/29/2000	1	CT Scan, CBC, Lytes	UNK	UNK			hx of slight headache 2 weeks prior to episodes and increased sense of smell			1						1	Amnesia; Confusional state	FLU3~PFIZER\WYETH~4008185~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0163764	12/14/2000	IL	54.0	54		M	12/04/2000	The pt complained of aching in the left shoulder, left scapular area, tingling in the the left little ring finger.				Y					N	11/29/2000	11/30/2000	1		PVT	PVT		NONE				1						1	Arthralgia; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4008174~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0163765	12/14/2000	CO	76.0	76		F	12/07/2000	The pt experienced hives, itching on legs, buttocks, back had some response to Benadryl. The next day had hives on waist and belly, 2 days later had hives on chest, scalp. The pt had 2 trips to urgent care, treated with Benadryl, methylprednisolone, Atarax with full recovery by 4 days post vax.				Y					Y	12/01/2000	12/01/2000	0		PUB	PUB		NONE	NONE			1						1	Pruritus; Urticaria	FLU3~PFIZER\WYETH~4008183~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0163775	12/14/2000	CT	69.0			F	11/15/2000	Post vax, the pt developed diarrhea and hematoemesis. Subsequent dx of c diff colitis on 11/12/00. Pt developed acute severe hypercarbic respiratory failure. On 11/14/00, suspects respiratory failure from possible muscle weakness.			Y						U	10/11/2000	10/11/2000	0	CSF protein-31	UNK	UNK	ampicillin IV, solu-medrol IV, Cipro, albuterol nebs					1						1	Colitis; Diarrhoea; Haematemesis; Respiratory failure	FLU3~AVENTIS PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0163781	12/15/2000	CA	30.0	30		F	12/09/2000	While vacationing, went to the ER with slurred speech, diplopia, poor gait, tightness abdomen and chest. The pt was subsequently admitted to the hospital. Diagnosed with Guillian Barre syndrome, Miller Fisher variant.  Follow up on 01/17/2001: Final diagnosis: Guillain-Barre Syndrome, diagnosis was made by neurologist.Patient had previous influenza vaccinations.  Follow up on 07/06/2001: No acute illnesses prior to onset of GBS.  Immunizations received for influenza was 97 or 98 and 10/1999.  Final diagnosis was GBS.				Y	Y				Y	11/09/2000	11/18/2000	9		OTH	PVT	NONE	NONE	NONE			1						1	Abdominal discomfort; Chest discomfort; Diplopia; Dysarthria; Gait disturbance; Guillain-Barre syndrome; Asthenia; Diplopia; Guillain-Barre syndrome; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E68780KA~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Hospitalisation	Influenza
0163784	12/15/2000	SC	6.0	6		F	12/04/2000	Mother states son complained of pain following the vax in the right arm. The pt also experienced swell of the sight. The pt did not sleep well and did not attend school the following day. The pts arm was red from the injection site to the wrist. The pt was seen in the ER with a fever of 102. Was given antibiotics and released.				Y					Y	11/20/2000	11/20/2000	0		PUB	UNK		NONE	asthma			1						1	Injection site erythema; Injection site oedema; Injection site pain; Malaise; Pyrexia; Sleep disorder	FLU3~MEDEVA PHARMA, LTD.~E66350HA~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~469133~1~SC~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0163785	12/15/2000	SC	10.0	10		F	12/04/2000	Mother states that the pt complained of her left arm hurting immediately following vax. She did not attend school the following day because she did not sleep well and ran a low grade temp. The mother observed right arm redness from the injection site to the wrist. Seen in the ER with a temp of 101.9. Given antibiotics and released.				Y					Y	11/20/2000	11/20/2000	0		PVT	UNK		NONE	asthma			1						1	Injection site erythema; Injection site pain; Pyrexia; Sleep disorder	FLU3~MEDEVA PHARMA, LTD.~E663504A~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~469133~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0163786	12/15/2000	IA	22.0	22		M	12/13/2000	The pt experienced his left eyelid not closing as often or as briskly, drooping of the left side of his lip, numbness in left cheek, left side of face. Tongue protrudes, pulls to left. The pt was diagnosed with Bell's Palsy, treated with Prednisone.				Y					U	12/08/2000	12/09/2000	1		PUB	PVT		NONE				1						1	Facial palsy; Hypoaesthesia	FLU3~AVENTIS PASTEUR~U0416BA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163787	12/15/2000	OH	92.0	92		F	11/03/2000	The pt developed an influenza like illness.				Y					U	10/27/2000	10/29/2000	2		OTH	OTH	Norvasc, HCTZ	NONE	hypertension, arthritis			1						1	Influenza	FLU3~AVENTIS PASTEUR~U0406AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163788	12/15/2000	MO	73.0	73		M	12/06/2000	The pt experienced redness, warmth to the touch at the injection site. Treated with Benadryl for 3 days. Redness resolved.									Y	11/09/2000	11/09/2000	0		UNK	UNK						1						1	Injection site erythema; Injection site warmth	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163789	12/15/2000	PA				U	12/07/2000	The pt experienced cellulitis from the injection site to below the elbow.									U	12/05/2000	12/05/2000	0		UNK	UNK						1						1	Cellulitis; Injection site reaction	FLU3~PFIZER\WYETH~4008183~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163790	12/15/2000	MN	53.0	53		F	12/07/2000	The pt experienced redness, swelling of arm to golf ball size, lightheadedness, migraine type headache. The pt called the ER for advice over the weekend.									Y	12/01/2000	12/01/2000	0		PVT	PVT	Clonodine, Wytenston, Claritin, Flovent, Ventolin, Albuterol, Prempro, Lipitor, Midrin, Nasacort, Indapamide, Atenolol Amoten, Prilosec, B Complex, Vitamin E	NONE	multiple drug allergies			1						1	Dizziness; Injection site erythema; Injection site oedema; Migraine	FLU3~PFIZER\WYETH~4008188~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163791	12/15/2000	CA	44.0	44		F	11/20/2000	The pt experienced fine pin-point sized rash and flattened lines over abdomen, buttocks and upper extremities approximately 24 hours post vax.				Y					Y	11/01/2000	11/01/2000	0	NONE	OTH	PVT	NONE	NONE	hx of uterine cancer, asthma, eczema			1						1	Rash; Skin striae	FLU3~MEDEVA PHARMA, LTD.~E71290LA~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0163792	12/15/2000	NC	62.0	62		F	12/02/2000	The pt experienced a localized reaction to the left arm deltoid area. The left deltoid area was red, a little swollen. Aching all over. Pt was afebrile. Area is indurated, warm 4cm size. No joint edema.									Y	11/30/2000	12/01/2000	1		PVT	PVT	Lopressor, Indur, Zocor, Prilosec, desyrel, Depakote					1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site reaction; Pain	FLU3~MEDEVA PHARMA, LTD.~E68780KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0163793	12/15/2000	NY	18.0	18		F	12/11/2000	The pt became hoarse 45 minutes post vax and remained hoarse 24 hours later.									Y	12/06/2000	12/06/2000	0		PVT	PVT			medulloblastoma			1						1	Dysphonia	FLU3~AVENTIS PASTEUR~U0436AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163794	12/15/2000	MS	42.0	42		F	11/28/2000	Approximately 30 minutes post vax, the pt experienced an injection site that was reddened and the pt also complained of soreness at the site.									Y	11/28/2000	11/28/2000	0		PUB	PUB	Nasonex, Celebrex, Methotrexate, Premarin, Folic Acid	NONE	psoriatic arthritis		MS00052	1						1	Injection site erythema; Injection site pain	FLU3~PFIZER\WYETH~4008182~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163795	12/15/2000	MS	54.0	54		F	11/29/2000	The pt experienced redness, swelling at the injection site on the left arm with occasional pain and soreness.									U	11/27/2000	11/27/2000	0		PUB	PUB	NONE	NONE	NONE		MS	1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~8008182~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163808	12/15/2000	PA	40.0			F	12/07/2000	Post vax, the pt developed cellulitis of arm, lymphadema, decreased blood pressure, and whole body flushed.					Y				U	12/05/2000	12/05/2000	0		UNK	UNK						1						1	Blood pressure decreased; Cellulitis; Flushing	FLU3~PFIZER\WYETH~4008183~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0163809	12/15/2000	CT	69.0			F	11/15/2000	Post vax, the pt presented to clinic with diarrhea and hematoemesis. Subsequent dx of c. diff. colitis on 11/12/00. Pt developed acute severe hypercarbic respiratory failure. 11/14/00, suspects respiratory failure from possible muscle weakness.			Y						U	10/11/2000	11/12/2000	32	CSF protein-31	UNK	UNK	ampicillin IV, solu-medrol IV, Cipro, albuterol nebs		breast cancer locally advanced metastatic			1						1	Colitis; Diarrhoea; Haematemesis; Respiratory failure	FLU3~AVENTIS PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0163816	12/18/2000	MD				M	12/14/2000	A pharmacist with a history of multiple sclerosis (dx'd at age 45) reported that he received an injection of Flu Shield (1996-1997 Formula) in 1996 and approx. 2 weeks later, was unable to control his legs, had blurred vision and was unable to write. The pt was hospitalized for several weeks and a dx of a flare up of pre-existing multiple sclerosis was made. Therapy with baclofen, lisinopril, fluoxetine hydrochloride and diphenoxylate hydrochloride/atropine sulfate was initiated. He was then transferred to a rehabilitation facility to learn to walk again. The pt regained his ability to walk: however, he dragged the right side of his body.					Y				U				UNK	OTH	OTH	UNK	UNK	Multiple Sclerosis (dx'd at the age or 45)		HQ4722112DEC2000	1						1	Abasia; Multiple sclerosis; Muscle disorder; Vision blurred	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0163829	12/18/2000	KY	65.0	65		M	11/29/2000	The pt developed herpes zoster after the flu vax. He developed a painful herpetic rash on the right side of back and right upper chest.				Y					U	11/20/2000	11/21/2000	1		PVT	UNK		herpes zoster, weakness	allergic rhinitis		KY2000044	1						1	Herpes zoster; Infection; Pain	FLU3~MEDEVA PHARMA, LTD.~E72230MA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0163830	12/18/2000	CA	80.0	80		U	12/08/2000	The pt experienced inner ear trouble, dizzy getting in and out of bed.				Y					Y	11/03/2000	11/05/2000	2	NONE	PUB	UNK	NONE	NONE	NONE			1						1	Dizziness; Ear disorder	FLUX~UNKNOWN MANUFACTURER~IMM5693~7+~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0163832	12/18/2000	CA	19.0	19		M	11/29/2000	The pt experienced a pruritic macular erythematous rash. Onset was 8-10 hours post vax. 1 day post vax, the pt experienced a sore throat, 2 days post vax the pt developed myalgias and fever.				Y					N	11/25/2000	11/25/2000	0		PVT	PVT	NONE					1						1	Myalgia; Pharyngolaryngeal pain; Pruritus; Pyrexia; Rash erythematous; Rash macular	FLU3~AVENTIS PASTEUR~U0398AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163833	12/18/2000	WA	67.0	67		F	12/04/2000	The pt experienced pain in the left arm within 2 hours of vax, began swelling within 4 hours. The pt became dizzy, nauseated with sore arm, within 6 hours. The pt experienced generalized symptoms lasting for 24 hours. Pain, swelling, and redness of left arm continued for 2 days. On each day, the swelling progressed distally in the arm. By the 3rd day, swelling continued, but the pain and redness were going. Function was not impaired.									U	12/01/2000	12/01/2000	0	NONE	PUB	PUB	vitamins	NONE	allergy to sulfa	extreme localized soreness~Tetanus Toxoid (no brand name)~~40.00~In Patient	WA001708	1						1	Dizziness; Injection site erythema; Injection site oedema; Injection site pain; Nausea	FLU3~PFIZER\WYETH~4008193~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~473554~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0163834	12/18/2000	WA	70.0	70		F	11/15/2000	1 hour post vax, the pt developed redness, soreness and a small lump at the site of the injection on her left arm. It got worse and she couldn't move her arm. She developed chills and aches and the lump increased in size onto her shoulder. She took aspirin that day 2 times. The symptoms decreased.									U	11/14/2000	11/14/2000	0	NONE	PUB	OTH	NONE	NONE	Psoriasis	sick~Influenza (Seasonal) (no brand name)~~30.00~In Patient	WA001704	1						1	Chills; Hypokinesia; Injection site erythema; Injection site mass; Injection site pain; Pain; Similar reaction on previous exposure to drug	FLU3~PFIZER\WYETH~4008174~7+~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0690K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0163835	12/18/2000	WA	69.0	69		F	11/03/2000	The pt experienced localized redness to the left deltoid where the vaccine was given.									U	10/26/2000	10/27/2000	1	NONE	PVT	UNK	ibuprofen	NONE	osteoarthritis		WA001703	1						1	Injection site erythema	FLU3~AVENTIS PASTEUR~U0337AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163836	12/18/2000	WA	38.0	38		F	11/01/2000	The pt experienced swelling of the throat and difficulty swallowing within 2 hours of flu shot. The pt was treated with epinephrine and Benadryl.				Y					Y	10/13/2000	10/13/2000	0	NONE	PUB	UNK	Birth Control Pills	NONE			WA001702	1						1	Dysphagia; Pharyngeal oedema	FLU3~AVENTIS PASTEUR~U0400AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163837	12/18/2000	WA	38.0	38		F	11/01/2000	The pt experienced subnormal temperature, chills, sweats, extreme fatigue, sore throat, itchy eyes, runny nose, sneezing, congestion, and body aches.									U	10/30/2000	10/31/2000	1		UNK	UNK		NONE			WA001701	1						1	Body temperature decreased; Chills; Eye disorder; Fatigue; Hyperhidrosis; Nasal congestion; Pain; Pharyngolaryngeal pain; Pruritus; Rhinorrhoea; Sneezing	FLU3~AVENTIS PASTEUR~U0400AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163838	12/18/2000	WA	41.0	41		F	10/31/2000	The pt experienced edema, bruising, redness, swelling, and nausea. Symptoms began 10/27/00. No vomiting was experienced.									Y	10/25/2000	10/27/2000	2		PVT	UNK		NONE	hypertension, allergy to HCTZ, TB as a child		WA001700	1						1	Contusion; Erythema; Nausea; Oedema	FLU3~AVENTIS PASTEUR~U0400AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163839	12/18/2000	MS	62.0	62		F	12/07/2000	Approximately 2 hours post vax, the pt returned to the clinic with a complaint of swelling, heat, soreness, redness radiating approximately 3 surrounding injection area.									U	12/01/2000	12/07/2000	6		PUB	PUB		NONE	tetanus and iodine		MS00054	1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLU3~PFIZER\WYETH~4008198~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~472210~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0163840	12/18/2000	MS	40.0	40		F	12/06/2000	The pt experienced a large reddened area, fever and achiness for 2 days.									U	12/04/2000	12/05/2000	1	NONE	PUB	PUB	Albuterol		lung problems		MS00053	1						1	Erythema; Pain; Pyrexia	FLU3~PFIZER\WYETH~400818~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~472210~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0163841	12/18/2000	NJ	47.0	47		F	12/08/2000	The pt's eyes began to itch on 11/5. By 11/6 the pt had full periorbital swelling and itching lasting 4 days. The pt also developed red rash at the vaccine site. Eventually had generalized facial edema.				Y					Y	11/04/2000	11/04/2000	0	NONE	PUB	PUB		NONE	allergy to bacitracin	edema~Influenza (Seasonal) (no brand name)~~45.00~In Patient	NJ200024	1						1	Erythema; Eye disorder; Face oedema; Injection site rash; Periorbital oedema; Pruritus	FLU3~AVENTIS PASTEUR~U0346AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163842	12/18/2000	SC	58.0	58		M	11/21/2000	Developed pain at injection site within 1 hour. 11/16/00 AM, redness and swelling at injection site, progressively increasing with increased temperature to 99.7F. Called doctor and ordered Benadryl and cold compresses. 11/17/00, increased swelling, redness and warmness from 5 above elbow to wrist with increased temperature to 100F. Used warm compresses and Benadryl. Went to ER at 20:00 on 11/17/00. Rx'd Unisom IV, Augmentin po. 11/20/00, decreased swelling of arm. 11/21/00, decreased swelling hand.				Y					Y	11/15/2000	11/15/2000	0	CBC-WBC-11,100; po 73%, lymphs 18%, monocytes 6%, eosinephils 2%, Hgb-15.2, HcT-45, PT-18.8 and NR 2.9	PUB	PUB	Lipitor, Coumadin, Glucotrol	NONE	Heart valve replaced 1992; High BP; High Cholesterol		SC00078	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pyrexia	FLU3~AVENTIS PASTEUR~U0417AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~469133~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0163843	12/18/2000	SC	76.0	76		F	12/05/2000	At 15:20, vaccinations given; at 15:35, pt complained of feeling hot and woozy BP 179/108; P-84. Placed pt in supine position and elevated feet. Pt warm to touch. Cool towel applied to neck and head. At 15:45, BP 186/98; pt reported feeling better but legs numb. MD notified and pt sent to ER via husband. Dx'd with anxiety due to injections.				Y					Y	12/04/2000	12/04/2000	0		PUB	PUB	Anti-hypertensive meds	NONE	Arthritis, hypertension		SC00076	1						1	Anxiety; Dizziness; Feeling hot; Hypertension; Hypoaesthesia	FLU3~AVENTIS PASTEUR~U0439DA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466444~1~SC~LA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~U0267AA~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0163844	12/18/2000	SC	35.0	35		F	11/28/2000	45 minutes, post vax, pt began having difficulty with speech. Speech was slurred and she said she didn't feel right. BP 104/70 (normal for pt is 130/90); Pulse 104. No difficulty breathing. Had some dizziness. Notified pt's MD who ordered 50 mg of Benadryl. Pt refused to go to ER.									Y	11/22/2000	11/22/2000	0	NONE	PUB	PUB	NONE	Slurred speech, dizziness	NONE		SC00072	1						1	Dizziness; Dysarthria; Feeling abnormal; Hypotension	FLU3~AVENTIS PASTEUR~U0417AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163845	12/18/2000	DC	66.0	66		F	12/13/2000	Within hours on the same day of vax, pt experienced severe pain, swelling and redness at the injection site, accompanied by a high fever. Family doctor contacted and was seen in 24 hours. Dx'd with acute cellulitis, left deltoid area, at Pnu-Imune site. Rx'd IV antibiotics in doctor's office and antibiotic therapy at home.				Y					U	11/08/2000	11/08/2000	0		OTH	PVT						1						1	Cellulitis; Injection site erythema; Injection site pain; Injection site swelling; Pyrexia	FLU3~AVENTIS PASTEUR~U0416CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~463748~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0163846	12/18/2000	NY	15.0	15		F		Pt was seen by physician. She had swelling on lips and face. This was worse in the morning (per nurse report) Vital signs were stable. Chest and lungs were clear. No breathing problems.				Y					Y	11/28/2000	11/30/2000	2	NONE	PVT	OTH						1						1	Swelling face	FLU3~PFIZER\WYETH~4008180~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0163847	12/18/2000	IA	67.0	67		F	12/12/2000	Flu shot given on 11/13/00. Glands were swollen, 8 hours later, with swelling in front of ears. Dizzy. Had red rash on legs and arms, sick to stomach; lasted 2 days but felt weak for days. Put me to bed for 2 full days. Had temperature. Had rash for 10 days.									Y	11/13/2000	11/14/2000	1		PUB	UNK		Bladder infection				1						1	Asthenia; Dizziness; Lymphoedema; Nausea; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0163848	12/18/2000	WI	41.0	41		F	11/30/2000	11/29/2000, started at 12:30, itching, redness (everywhere), increased BP and temperature. Went to her own MD. She reported she was treated with 40mg of prednisone and Benadryl and also a breathing treatment.				Y					Y	11/28/2000	11/29/2000	1	NONE	OTH	PVT	Folic acid, sulfadiazine	NONE	Splenectomy			1						1	Erythema; Hypertension; Pruritus; Pyrexia	FLU3~AVENTIS PASTEUR~U0422EA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163849	12/18/2000	MA	28.0	28		F	12/08/2000	Pt returned to flu clinic area complaining of feeling jittery. BP at the time was 134/88, HR-76. Symptoms increased to feeling very hot. Face was flushed, BP increased to 150/100, HR-100 and complaining of mucous feeling in throat. Seen by MD, given Atarax 25mg. Pt allergic to Benadryl. No shortness of breath. Pt fidgety. BP decreased after 30 minutes to 138/94. Monitored for a total of 90 minutes. Returned to work at 09:20. BP 132/74; HR-80.				Y					Y	12/07/2000	12/07/2000	0		PVT	PVT		NONE	Pt states sensitivity to other medications and medication allergies			1						1	Feeling jittery; Flushing; Heart rate increased; Hypertension; Throat tightness	FLU3~PFIZER\WYETH~4008192~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0163885	12/19/2000	MD	57.0	57		M	12/15/2000	2 weeks following the vax, the pt could not control his legs. The pt was holding on to a shopping cart and was unable to control the cart. He subsequently fell to the ground. He was hospitalized and is now wheelchair bound. According to his wife, he has lost control of his bladder and bowels as well. He has also lost his cognitive reasoning.					Y				U	10/01/1997	10/14/1997	13	UNK	OTH	OTH	Lioresal, Lomotil, Prozac, Zestril	UNK	Multiple Sclerosis	aggravation of MS~Influenza (Seasonal) (FluShield)~~0.00~In Patient	HQ4802413DEC2000	1						1	Difficulty in walking; Faecal incontinence; Fall; Sopor; Urinary incontinence	FLU3~PFIZER\WYETH~~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0163900	12/19/2000	KY	60.0	60		F	12/11/2000	Chills for 2 1/2 days, nausea, BP decreased to 100/55 (2 days), light-headedness and dizzy but no fever.									Y	11/15/2000	11/17/2000	2	NONE	PVT	PVT		NONE	NONE			1						1	Chills; Dizziness; Hypotension; Nausea	FLU3~AVENTIS PASTEUR~U0428AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163901	12/19/2000	NY	74.0	74		F	12/12/2000	Chills, fever, muscle ache and unusual weakness, lasted for 3 days.									Y	11/18/2000	11/18/2000	0		PUB	OTH						1						1	Asthenia; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4008179~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163902	12/19/2000	IN	6.0	6		M	11/30/2000	No data provided.									Y	11/24/2000	11/25/2000	1		PVT	PVT	Allegra, Singulair, Vancenase AQ NS					1						1	Unevaluable event	FLU3~AVENTIS PASTEUR~U0422EA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~468136~UNK~IM~LA~PNEUMO (PREVNAR)~1	USA		Influenza
0163903	12/19/2000	CA	47.0	47		F	12/11/2000	Arm became very sore and tender to touch and hives around shot site. Took Benadryl and applied ice. On 12/6/99, saw the doctor. Rx'd for Atarax. Missing informtion is unavailable.				Y					Y	12/04/2000	12/04/2000	0	NONE	PVT	OTH	necon; BC pills	NONE	Asthma			1						1	Hypersensitivity; Injection site pain; Urticaria	FLUX~UNKNOWN MANUFACTURER~~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~IM~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0163904	12/19/2000	OH	60.0	60		F	12/15/2000	Post vax, complained of itchy hands, red and raised areas appeared in a couple of minutes. At 13:00, arrived at ER with some respiratory difficulty, throat swelling and treatment was given. At 14:00, discharged home with improvement. On 12/15/00, returned to work.				Y					Y	12/14/2000	12/15/2000	1	NONE	PUB	UNK	Monopril, Claritin, hydrochlorothinzide, Premarin	12/13/00; headache and nausea during the night	Hypertension, arthritis, allergies to dye and Demerol			1						1	Pharyngeal oedema; Pruritus; Rash erythematous; Respiratory distress	FLU3~PFIZER\WYETH~4008198~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0163905	12/19/2000	TX	59.0	59		F	12/14/2000	20 minutes, post vax, pt became dizzy, slightly nauseated and skin color was pale, fingers tingling, red hot. BP 139/80, P 76, no SOB. Benadryl 25mg po given and pt felt better after 10 minutes. At 14:40, 20 minutes after Benadryl, pt ready, no dizziness, no tingling and felt good. BP 130/80 and P 66.									Y	12/07/2000	12/07/2000	0		PUB	OTH	HCTZ, Norvasc, K-Dur, Synthroid	NONE	Allergic to ASA			1						1	Dizziness; Erythema; Hypertension; Nausea; Pallor; Paraesthesia	FLU3~PFIZER\WYETH~4009180~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163906	12/19/2000	MA	75.0	75		F	12/06/2000	Pt has had pain in biceps and deltoid and trapezius since about 2-3 days, post vax. She denotes loss of function secondary to discomfort. No headache or fever. Clinical picture is with polymyalgia rheumatica.				Y					N	10/26/2000	10/28/2000	2	CBC, TSH, CPK, CMP-all wnl; Cervical and Thoracic spine series; ESR-64	PUB	PUB	Vitamin B12/0347/LA/12 previously, Zantac, E-vista, MVI, vitamin E, Ca ++/mg +	NONE	Psoriasis, Pernicious type anemia, post menopausal, Barrett's syndrome (esophagus), Irritable Bowel Syndrome			1						1	Hypokinesia; Injection site pain; Polymyalgia rheumatica; Red blood cell sedimentation rate increased	FLU3~AVENTIS PASTEUR~U0400AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163907	12/19/2000	VA	50.0	50		M	10/26/2000	Pt complained of nausea, vomiting, 1 day post vax. Also had fever, body aches, fatigue, malaise and headaches.									Y	10/25/2000	10/26/2000	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Fatigue; Headache; Malaise; Nausea; Pain; Pyrexia; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E65610HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0163908	12/19/2000	CA	7.0	7		F	12/08/2000	Injection site was erythematous, edematous, tender to touch and warm to touch.									U	12/07/2000	12/08/2000	1	NONE	PVT	PVT	NONE	NONE	IGA deficiently			1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLU3~AVENTIS PASTEUR~L0446AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163909	12/19/2000	CT	51.0	51		M	12/07/2000	Post vax, the pt developed a raspy cough, rhinorrhea, coryza, purulent eye discharge, aches, chills, and fever.									Y	12/06/2000	12/06/2000	0		PVT	PVT	NONE	NONE	NONE			1						1	Cough; Eye discharge; Pyrexia; Rhinitis; Rhinorrhoea	FLU3~AVENTIS PASTEUR~U0441AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163910	12/19/2000	NY	55.0	55		F	12/11/2000	Light pink rash, hot to touch, a little swelling. She was told by my nurse (RN) to take 2 Tylenol every 4 hours and rest. Itched. Only lasted 1 day. Never had this problem before.									Y	11/20/2000	11/22/2000	2	NONE	PUB	OTH	Diabetes, asthma, arthritis	NONE	Allergic to penicillin and sulfa			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~161480069~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0163911	12/19/2000	PA	44.0	44		F	12/13/2000	Rash that started at the site of the injection and moved down into underarm area. It lasted 1 week.									Y	12/08/2000	12/09/2000	1	NONE	OTH	PVT	BP meds	NONE	High BP			1						1	Injection site rash; Rash	FLU3~PFIZER\WYETH~4008190~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163912	12/19/2000	WA	75.0	75		F	12/01/2000	Within a few hours, post vax, pt states arm became sore and red. At the time of the health dept's visit on 12/1/00, arm is inflammed 3 X 4 around injection site, warm to touch and slightly distended.									U	11/29/2000	11/29/2000	0		OTH	PVT	Toprol, Cincadine, Premarin	NONE	Allergies to aspirin, Biaxin, sulfa, Claritin, etc; high blood pressure		WA001707	1						1	Injection site erythema; Injection site inflammation; Injection site pain; Injection site swelling; Injection site warmth	FLU3~PFIZER\WYETH~4008185~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163913	12/19/2000	DE	55.0	55		F	12/06/2000	11/29/00, left arm became swollen, hot, stiff and painful. 11/30/00, symptoms increased. Telephone call to MD; started taking Benadryl 25mg po every 8 hours. (Throbbing and itching). 12/1/00, MD says due to increased spreading of swelling and rash, prescribed Cefadroxil 500mg BID X 7 days. 12/5/00, taking antibiotics and symptoms have improved.				Y					Y	11/28/2000	11/29/2000	1	NONE	PUB	OTH	Diazide, Estrogen, verapamil	NONE	Low WBC; Hypertension; Mitral valve prolapse; Asthma		DE0007	1						1	Injection site pain; Injection site rash; Injection site swelling; Injection site warmth; Musculoskeletal stiffness; Pruritus	FLU3~AVENTIS PASTEUR~U0403AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~469133~7+~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0163939	12/20/2000	PA	76.0			F	11/30/2000	A previously healthy 70 year old woman presented with a 3 week history of severe headache, pain on chewing, malaise, fatigue, anorexia and weight loss. Significant to note that pt had IV, 1 week before the onset of her complaints. After multiple tests, a presumptive dx of GCA was made and the pt was treated with oral prednisone (50mg/d), which resulted in a rapid resolution of her complaints. The dosage of prednisone was gradually reduced over a period of 36 months.									Y				Multiple tests-After undergoing IV, our pt developed a disorder that fulfilled 4 of the 5 criteria for classification as GCA. The close temporal relationship between IV and the onset of GCA suggests that IV may have induced the GCA. Our pt was HLA-DRBI*04 positive, which suggests that she was genetically predisposed to develop GCA.	OTH	OTH	Prednisone	UNK	UNK		FLU24141100	1						1	Anorexia; Arteritis; Fatigue; Headache; Malaise; Pain in jaw; Weight decreased	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0163948	12/20/2000	CA	79.0	79		F	12/05/2000	As the pt was driving home after her flu shot, her nose started running, throat and chest got sore and tight. The next morning, her throat and chest so tight it was difficult to breath.				Y	Y	5			Y	11/29/2000	11/29/2000	0	chest x-ray	PUB	PUB	PPD / Connaught / Lot # C0150AA / 11/27/00	NONE	arthritis		CA000134	1						1	Chest discomfort; Chest pain; Dyspnoea; Pharyngolaryngeal pain; Rhinorrhoea	FLU3~MEDEVA PHARMA, LTD.~E73110LA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0163949	12/20/2000	SC	72.0	72		M	11/28/2000	The pt experienced a temp of 103, muscle aches, productive cough, slight shortness of breath. Taken to the ER by wife and admitted to hospital on 11/19/00. Treated with Cortisone.					Y	4			Y	11/18/2000	11/19/2000	1	CBC, WBC - 26,000	PUB	PUB	Xanax, Baclifen, Darvocet, aspirin		hx of lung cancer, osteoarthritis, ASHD		SC00079	1						1	Cough; Dyspnoea; Leukocytosis; Myalgia; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E66350HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0163950	12/20/2000	TX	51.0	41		M	10/18/2000	The pt experienced an improperly placed Anthrax injection. The vax was injected into the ulnar nerve and the subcutaneous nerve. The event triggered immune response in/on both nerves. At the time extreme neuropathic pain which subsided to moderate, loss of strength, and motion. Treated with steroids with little improvement. Symptoms still persist. On 60 Day FU: same symptoms as previously reported are still relevant and related to this adverse event, there has been no change.				Y				Y	N	11/04/1999	11/04/1999	0	EMG - abnormal	MIL	MIL	Mevacor	NONE	hypercholesterolemia			1						1	Asthenia; Hypokinesia; Immune system disorder; Laboratory test abnormal; Neuralgia; Neuropathy; Pain	ANTH~MICHIGAN DEPT PUB HLTH~FAV024~4~IM~LA~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0163963	12/20/2000	CA	0.7	0	.7	F	12/11/2000	The patient has hypersensitivity, generalized maculopapular rashes. Treated Benadryl.									Y	11/22/2000	11/23/2000	1	NONE	PVT	PVT		NONE	Down Syndrome, failure to thrive			1						1	Rash maculo-papular	FLU3~MEDEVA PHARMA, LTD.~E70140LA~1~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PNC~PFIZER\WYETH~473344~1~~~PNEUMO (PREVNAR)~1	USA		Influenza
0163966	12/20/2000	MA	37.0	37		F	12/11/2000	Immediately, post vax, area felt painful. Very painful on 11/4/00 and 11/5/00. Continued to hurt. No redness or swelling visible but tender to touch. Difficulty lifting or reaching with left arm. Still painful today, 12/11/00 and was referred to MD.									N	11/03/2000	11/03/2000	0	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Hypokinesia; Injection site pain; Pain	FLU3~AVENTIS PASTEUR~00403AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163967	12/20/2000	MA	50.0	50		F	10/25/2000	On 10/24/00, in the evening, she noticed her arm was swollen just below the shoulder, extending to elbow and 3/4 diameter around arm. It felt sore and hard. She saw a doctor who said it was either cellulitis, infection or allergy. Pt was put on Cethalxine 500mg BID X 10 days.				Y					Y	10/23/2000	10/24/2000	1		OTH	PVT	Premarin	NONE	Seasonal, mild allergies; S/P hysterectomy			1						1	Cellulitis; Injection site hypersensitivity; Injection site induration; Injection site infection; Injection site pain; Injection site swelling	FLU3~AVENTIS PASTEUR~U0410AA~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163968	12/20/2000	WA	54.0	54		F	12/12/2000	Left arm paresis, 3-5 days, post vax. Resolving paresis with physical therapy.									Y	11/18/2000	11/22/2000	4	EMG/NCV	PVT	PVT	NONE	NONE	NONE			1						1	Paresis	FLU3~PFIZER\WYETH~4008187~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163969	12/20/2000	MO	65.0	65		F	12/13/2000	Localized reaction on left arm with cellulitis and low-grade fever and pruritus around site.									Y	12/08/2000	12/11/2000	3	NONE	PVT	PVT	Vioxx, atenolol, colchicine, HCTZ, Prilosec, Lotensin, E-Vista	NONE	NONE			1						1	Cellulitis; Injection site reaction; Pruritus; Pyrexia	FLU3~PFIZER\WYETH~4008185~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~470592~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0163970	12/20/2000	MN	56.0	56		F	12/14/2000	Pt called clinic on 12/14/00 at 11:30 and states she received flu shot on 12/13/00 at 08:00 and about 1/2 hour, post vax, she developed pain across the middle of her back. She denied shortness of breath, itching, rash or difficulty breathing; denied fever or chills. States no other problem and the pain continues today, 12/14/00; no other signs or symptoms; no treatment.									U	12/13/2000	12/13/2000	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Back pain	FLU3~AVENTIS PASTEUR~U0440AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163971	12/20/2000	MO	70.0			F	12/13/2000	Localized reaction of left forearm with cellulitis. No fever or pruritus.									Y				NONE	PVT	PVT	Cytotec, Persantine, Feldene, Inderal LA	NONE	Allergy to Pontocaine			1						1	Cellulitis; Injection site reaction	FLU3~PFIZER\WYETH~4008185~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~470592~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0163972	12/20/2000	TX	6.0	6		M	12/07/2000	Swollen, hot and tender area on both deltoids, 8cm X 8cm left, 7cm X 6cm right. The dose was split, due to swelling elbow to shoulder with flu vaccine last year.									U	12/07/2000	12/07/2000	0	NONE	MIL	MIL	Biaxin	Sinus infection	Asthma; allergy to cats	Swelling~Influenza (Seasonal) (no brand name)~~5.00~In Patient		1						1	Injection site pain; Injection site swelling; Injection site warmth; Similar reaction on previous exposure to drug; Unevaluable event	FLU3~PFIZER\WYETH~4008209~5~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163973	12/20/2000	SC	30.0	30		F	12/11/2000	Went to ER on 12/8/00 and was treated for cellulitis on the right arm. I was sedated; drainage tube inserted and IV antibiotics administered.				Y					U	12/06/2000	12/08/2000	2	Culture grew out Staph	PUB	PUB		NONE	NONE		SC00081	1						1	Bacterial infection; Cellulitis; Injection site reaction	FLU3~AVENTIS PASTEUR~U0439DA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~469133~UNK~SC~RA~PNEUMO (PNU-IMUNE)~1|TTOX~CONNAUGHT LABORATORIES~U0267AA~UNK~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1|TYP~CONNAUGHT LABORATORIES~P142750~UNK~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0163974	12/20/2000	WA	1.0	71		M		A severe case of hives; used antihistamine and subsided in a couple of days.									Y	11/14/2000	11/16/2000	2	NONE	OTH	OTH						1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~4~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0163975	12/20/2000	CA	48.0	48		F	12/05/2000	Pt called complaining of pain on left shoulder joint, 2 days, post vax and at present time. Pt stated that she took ibuprofen tablets for pain and helps minimal for pain. Pt stated no history of pain on shoulder and joints.									N	11/21/2000	11/23/2000	2	NONE	PUB	PUB	NONE	NONE			CA000136	1						1	Arthralgia	FLU3~PFIZER\WYETH~E71780LA~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163976	12/20/2000	CA	60.0	60		F	12/05/2000	Pt complained of pain on left arm and shoulder joints, 2 days post vax. Pt stated she had taken Motrin for pain in shoulder and joints. Pt states she had tendonitis problem in left shoulder before. Stated this pain got intense after the flu shot. Slightly relieved after taking ibuprofen, as per pt statement.									N	11/21/2000	11/22/2000	1	NONE	PUB	PUB	NONE	NONE	Tendonitis		CA000135	1						1	Arthralgia; Injection site pain	FLU3~PFIZER\WYETH~E71780LA~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163977	12/20/2000	CA	65.0	65		M	12/07/2000	Night of injection, pt had discomfort in left shoulder down (never had fever, site not hot to touch). The next day, it was swollen and same discomfort. On the 2nd day, had increased swelling and decreased discomfort but redness at the injection site to wrist. No mobility restrictions.									N	12/05/2000	12/05/2000	0		PUB	PUB	NONE	NONE	NONE		CA000137	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~MEDEVA PHARMA, LTD.~E73110LA~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~468136~2~SC~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0163978	12/20/2000	WI	46.0	46		F	12/09/2000	Difficult breathing, confused, disoriented, injection site swollen the size of a 16 baseball and knotted, hurt, burned and burning down arm and up to shoulders. Had to be monitored in ER. Severe reaction to shots. Got a shot of Benadryl and took 150mg of Benadryl for 3 days.				Y					Y	11/04/2000	11/05/2000	1	EKG; BP	PVT	OTH	Mental health medications	NONE	Allergy to mold and pollen; depression			1						1	Confusional state; Dyspnoea; Injection site mass; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0163979	12/20/2000	UT	69.0	69		F	12/09/2000	Warm, red and sore.									U	12/07/2000	12/07/2000	0		UNK	UNK						1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~AVENTIS PASTEUR~U0417AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0690K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0163980	12/20/2000	GA	65.0	65		F	12/13/2000	Fast heart beat, weakness and dizziness; for approx. 10 days.									Y	11/16/2000	11/17/2000	1		PUB	UNK						1						1	Asthenia; Dizziness; Heart rate increased	FLU3~PFIZER\WYETH~4008179~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163981	12/20/2000	MO	18.0	18		M	12/08/2000	Fever 100F-102F, body aches and malaise for 3 days. Recovered on 12/11/00.				Y					Y	12/06/2000	12/06/2000	0	NONE	UNK	UNK						1						1	Malaise; Pain; Pyrexia	FLU3~AVENTIS PASTEUR~U0455AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163982	12/20/2000	NY	34.0	34		F	12/14/2000	Skin rash on upper extremities; 30 minutes, post vax. No other symptoms. Symptoms resolved with Zyrtec.									Y	12/14/2000	12/14/2000	0	NONE	PUB	PUB	NONE	NONE	Allergy to thimerosol allergy			1						1	Rash	FLU3~PFIZER\WYETH~4008175~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163983	12/20/2000	MA	67.0	67		F	12/12/2000	Experienced stinging of needle and felt vaccine going in and radiating down the left arm. Sensation persist a few minutes. MD was notified. On 11/13/00, pt was called and she stated she was fine.									Y	12/12/2000	12/12/2000	0		OTH	PVT						1						1	Injection site pain	FLU3~PFIZER\WYETH~4008172~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163984	12/20/2000	PA	51.0	50		F	12/15/2000	Swelling under left arm.									U	12/13/2000	12/15/2000	2		OTH	UNK	Lotrel	NONE	NONE			1						1	Swelling	FLU3~AVENTIS PASTEUR~U0455AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163985	12/20/2000	NC	29.0	29		M	12/13/2000	Symptoms and sequelae of the Flu with severe laryngitis approx. 72 hours, post vax, had loss of speech, low-grade fever, joint pain, amber colored sputum, rhinorrhea and severe chapping of lips. Currently on Motrin 800mg TID. (Note: Pt has had these symptoms every year with this vaccination but symptoms have gotten progressively worse.)				Y					N	12/06/2000	12/08/2000	2		MIL	MIL	Motrin 800mg TID	NONE				1						1	Aphasia; Arthralgia; Influenza; Laryngitis; Pyrexia; Rhinorrhoea; Skin exfoliation	FLU3~PFIZER\WYETH~4008210~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0163986	12/20/2000	VA	53.0	53		F	12/13/2000	Red and swollen area, measuring 10cm X 3cm, warm and painful.									U	12/11/2000	12/12/2000	1		PUB	UNK						1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~PFIZER\WYETH~4009176~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163987	12/20/2000	WI	65.0	65		F	12/12/2000	Hives, itching and legs were swollen.									N	12/09/2000	12/10/2000	1		OTH	PVT	Tylenol	NONE				1						1	Pruritus; Swelling; Urticaria	FLU3~PFIZER\WYETH~4008190~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163988	12/20/2000	MO	21.0	21		M	12/11/2000	Generalized maculopapular and erythematous eruption; pruritic. Spares palms, soles and face. This appeared about 6 hours, post vax. Treated with Atarax 25mg for itching.									U	12/08/2000	12/08/2000	0	NONE	OTH	UNK	Tylenol	NONE	NONE			1						1	Injection site erythema; Pruritus; Rash maculo-papular	FLU3~AVENTIS PASTEUR~U0454AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163989	12/20/2000	WI	43.0	43		F	12/12/2000	Hives, itching.									U	12/08/2000	12/09/2000	1		OTH	PVT			Allergy to penicillin, TCN			1						1	Pruritus; Urticaria	FLU3~PFIZER\WYETH~4008190~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163990	12/20/2000	WI	45.0	45		M	12/11/2000	Approx. 1-2 hours, post vax, pt complained of shortness of breath with raspy cough. Appeared to have laryngospasm. Was seen by his MD and dx'd as a reaction to flu vax and given inhalers. Received lung RX with albuterol at MD's office.				Y					Y	12/08/2000	12/08/2000	0	NONE	PUB	PUB		NONE	Allergic to Bactrim			1						1	Cough; Dysphonia; Dyspnoea; Hypersensitivity; Laryngospasm	FLU3~PFIZER\WYETH~4008193~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0163991	12/20/2000	NY	79.0	78		F	11/26/2000	Itching, swelling, burning sensation and blisters. (Red lumps and spots, still remain). Treated with Benadryl and resolved in 1 week.				Y					Y	11/01/2000	11/01/2000	0	NONE	OTH	PUB	atenolol 50 mg	NONE	Mitral valve prolapse			1						1	Blister; Injection site erythema; Injection site mass; Injection site pain; Injection site swelling; Pruritus; Skin burning sensation	FLU3~AVENTIS PASTEUR~V0415AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0163993	12/20/2000	NE	66.0	66		F	12/12/2000	Received vaccine on 11/17/00 at 10:00 and at 14:00 was unable to abduct right arm. At 18:00, had nausea, pain at site and fever of 101F. Nausea and fever duration of 12 hours. Inability to abduct arm for 1 week. Pain right shoulder for more than 3 weeks. Orthopedic MD dx'd muscular allergy to vaccine; this individual only.									N	11/17/2000	11/17/2000	0	12/11/00 had X-ray of shoulder-neg	PUB	OTH		NONE	Allergies to PCN, Strep, Demerol, Detrol, Prempro			1						1	Hypersensitivity; Hypokinesia; Injection site pain; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1531J~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0163994	12/20/2000	NM	65.0	65		M	12/11/2000	Pt reports left deltoid injection site became swollen, tender and reddened down arm and into bicep area; today this is a 10cm area of redness with slight tenderness distal to the injection site over bicep.									Y	12/08/2000	12/08/2000	0		OTH	PVT	Multiple	NONE	PCN, vancomycin, and hydrocodone allergies; S/P MI; Hypercholesterolemia			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~PFIZER\WYETH~4008187~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0944K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0164020	12/20/2000	WA	74.0	74		M	11/28/2000	The patient's son states his father had a fever of 102.6 for three days. The sickness began the day after the Flu injection. His blood sugar was 71, severe trembling, and very soar in the rib cage area.									Y	10/18/2000	10/19/2000	1		PVT	PUB	Triamtesone, Prevacid, Amaryl,		Diabetes Type II, Atherosclerosis, pacemaker, Angioplasties, Stints, Quintuple bypass.			1						1	Pain; Pyrexia; Tremor	FLU3~AVENTIS PASTEUR~U0336BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163489	12/21/2000	CA				F	12/13/2000	The pt experienced hives and swelling of the lips.									Y	11/27/2000	11/27/2000	0		PUB	PUB		NONE				1						2	Chest pain; Dyspnoea; Swelling face; Urticaria; Face oedema; Urticaria	FLU3~MEDEVA PHARMA, LTD.~E71810LA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~E71810LA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0164027	12/21/2000	NH				U	12/18/2000	Post vax, the pt died. No further information was available at the date of this report. The reporter indicated that 9 pts experienced this event, however, they are not presently identifiable. 15 day follow-up states that the pt experienced flu-like symptoms as did a total of 9 pts.	Y								N				UNK	OTH	OTH	UNK	UNK	UNK		HQ4854614DEC2000	1						1	Influenza like illness	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0164036	12/21/2000	MT	76.0	76		F	12/14/2000	11/3/00, 3-4 hours post vax, she felt weak, lethargic and had diarrhea. Admitted to the hospital on 11/4/00 with hypovolemic shock and acute gastroenteritis. Diagnosed also with possible reaction to vaccines and cachexia. Per F/U 3/28/01: DX: CHF due to arteriosclerotic coronary disease, mitral regurgitation and tricuspid insufficiency. She had dehydration and was given IV fluids and responded quite promptly with an increase in strength and mental acuity. After slow improvement over a period of 5 days, she was discharged.			Y	Y	Y	6			Y	11/03/2000	11/03/2000	0	WBC - 32,000, Neutrophils - 96%, stool cultures - all negative	MIL	MIL	furosemide, digoxin, Synthroid, Nitrostat, Atenolol, Metolazone, Oxycodone, Alprazoam, Per F/U 3/28/01: potassium 16 milliequivalents AM and 24 PM; Lanoxin .0625mg daily		Allergy to penicillin; valvular insufficiency; CAD; Hypothyroidism, CHF			1						1	Asthenia; Cachexia; Cardiac failure congestive; Cardiac valve disease; Dehydration; Diarrhoea; Gastroenteritis; Hypovolaemia; Lethargy; Leukocytosis; Shock	FLU3~MEDEVA PHARMA, LTD.~E64650HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~465897~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Life Threatening,Hospitalisation	Influenza
0164043	12/21/2000	IN				U	12/19/2000	Post vax, the pt developed Guillain-Barre syndrome. No further information was available at the date of this report. FU received indicated the patient was an elderly female who received 1999-2000 formula influenza virus vaccine. See related case HQ5472103JAN2001.	Y								U				UNK	OTH	OTH	UNK	UNK	UNK		HQ4993318DEC2000	1						1	Guillain-Barre syndrome	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0164044	12/21/2000	WA				M	12/19/2000	A pharmacist reported that a male heart transplant recipient received an injection of flu vax and was subsequently rejecting the heart transplant.									U				UNK	OTH	OTH	UNK	UNK	heart transplant		HQ3804816NOV2000	1						1	Cardiac disorder	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164049	12/21/2000	OH	50.0	50		F	12/11/2000	Approximately one hour post vax the pt's hand became swollen and tingly. The pain and swelling has occurred intermittently for one month.				Y					N	11/09/2000	11/09/2000	0		PUB	UNK	Glucophase, vitamins, monopril, Premarin, ASA	NONE	hx of pneumonia, heart disease, hypertension, diabetes			1						1	Oedema peripheral; Paraesthesia	FLU3~AVENTIS PASTEUR~U0406AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~459837~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0164050	12/21/2000	OH	72.0	72		F	12/19/2000	The pt experienced prickly feeling lips, numbness of tongue and was flushed.									Y	12/16/2000	12/16/2000	0	NONE	PVT	PVT	Celebrex, Premarin	NONE	osteoarthritis, Fibromyalgia, osteoporosis, hyperlipidemia, depression			1						1	Flushing; Hypoaesthesia	FLU3~AVENTIS PASTEUR~U0443AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164051	12/21/2000	PA	67.0	67		F	12/14/2000	The pt experienced a fever, treated with Tylenol. The pt completely recovered.									Y	10/24/2000	10/24/2000	0		OTH	PVT	Oscal, Evista, Phenobarbitol, Vitamin B12, Dilantin	NONE	seizure disorder, anemia, Osteoporosis			1						1	Pyrexia	FLU3~AVENTIS PASTEUR~U0345AC~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0163781	12/22/2000	CA				F	12/19/2000	On 11/10/00, a female pt received Fluvirin, IM, in the left deltoid. One week, post vax, the pt developed double vision, tingling of her upper extremities, hands and lower legs with weakness also present in her lower legs. A dx of Guillain-Barre Syndrome was made by the pt's physician. The pt was hospitalized in ICU and has since been discharged home. No further information was available. Attempts to follow-up have been initiated.					Y				N	11/10/2000	11/17/2000	7		OTH	OTH	NONE		NONE		MPI2000049750	1						2	Abdominal discomfort; Chest discomfort; Diplopia; Dysarthria; Gait disturbance; Guillain-Barre syndrome; Asthenia; Diplopia; Guillain-Barre syndrome; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E68780KA~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Hospitalisation	Influenza
0164060	12/22/2000	PA	80.0			M	12/19/2000	Report received on 12/12/00, via telephone from a nurse regarding a possible adverse event associated with Fluvirin. On 11/1/00, an 80 year old male pt (DOB 8/1920), received vaccination with Fluvirin and 1 day later, developed a fever of unknown origin. The pt was seen in the ER and hospitalized. He was dx'd with pneumonia and died on 11/12/00 from respiratory failure secondary to the pneumonia. An influenza titer was done during the pt's hospitalization with negative results. On follow-up, the reporter also stated that the physician felt that it was a coincidence of events that ensued following vaccination. No other information was available at the present time. Attempts are being made to obtain further information. FU shows the pt had a non Q wave myocardial infarction.	Y	11/12/2000			Y				N	11/01/2000	11/02/2000	1	Influenza titer-neg	OTH	OTH	Coumadin		Arteriosclerotic cardiovascular disease; unknown atrial fibrillation		MPI2000049800	1						1	Drug ineffective; Myocardial infarction; Pneumonia; Pyrexia; Respiratory failure	FLU3~MEDEVA PHARMA, LTD.~E65620HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0164061	12/22/2000	CA	31.0			M	12/18/2000	Telephone report received from a physician on 12/11/00, regarding an adverse event related to administration of Fluvirin. An MD reported that he vaccinated his 31 year old son and approx. 8 days later, the son experienced an aura followed by a motor vehicle accident. The pt experienced a grand mal seizure which was witnessed by the paramedics at the scene of the accident and a subsequent grand mal seizure in the ER where he was treated and released. Further information has been requested.									Y	11/25/2000	12/09/2000	14	Computerized tomography and EEG revealed no significant findings.	PVT	OTH	NONE		Sleep disorder - early morning awakening		MPI2000049790	1						1	Aura; Grand mal convulsion; Road traffic accident	FLU3~MEDEVA PHARMA, LTD.~E68760LA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0164063	12/22/2000	NY	64.0	64		M	12/13/2000	Information has been received from a health professional concerning a 64 year old white male who on 10/25/00 was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent 1531J. It was noted that the pt received a 1st dose of pneumococcal vaccine 23 polyvalent in Oct/1995. On 10/25/00, he also received a 3rd dose of influenza vaccine (Fluzone U0428AA). On 10/27/00, the pt developed right arm cellulitis which extended to the elbow. The pt also experienced right arm swelling, redness and tenderness. The pt was prescribed 875 mg, twice daily of Augmentin. The pt subsequently recovered. The reporter indicated that the pt's experience was considered an Important Medical Event. Two additional pt's had a similar experience following exposure to pneumococcal vaccine 23 polyvalent 1531J. No further information is available.									Y	10/25/2000	10/27/2000	2		UNK	UNK			Malignant melanoma		WAES00111188	1						1	Cellulitis; Injection site erythema; Injection site pain; Injection site swelling	FLU3~AVENTIS PASTEUR~U0428AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1531J~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0164064	12/22/2000	NY	65.0	65		F	12/13/2000	On 11/10/00, pt was vaccinated in the left arm with a 2nd dose of pneumococcal vaccine 23 polyvalent. It was noted that the pt received a 1st dose in Dec/1996. On 11/10/00, pt also received influenza virus vaccine (Fluzone). It was reported that the pt had previously received influenza virus vaccine 5 or 6 times. On 11/11/00, the pt reported that she developed cellulitis. Follow-up information from a health professional reported that the pt had redness and swelling of left arm which began on 11/11/00. The pt was treated with Keflex, 250mg for 5 days. The reporter considered the left arm redness and swelling to be Important Medical Events. Subsequently, the pt recovered. Two additional pts had a similar experience following exposure to pneumococcal vaccine 23 polyvalent 1531J.				Y					Y	11/10/2000	11/11/2000	1		PVT	PVT	Synthroid		codeine and sulfa allergy		WAES00111189	1						1	Cellulitis; Injection site erythema; Injection site swelling	FLU3~AVENTIS PASTEUR~U0428AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1531J~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0164084	12/22/2000	CA	80.0	80		F	12/13/2000	Weakness, slight temperature 99.5F and redness of extremities (arms) at injection site. To ER on 11/29/00 at 23:16. Admitted for fever, leukocytosis and falls on 11/30/00 at 01:32. Given IV fluids and labs. On 12/1/00, discharged home.					Y	1			Y	11/28/2000	11/28/2000	0	WBC-on admission 26,000 and on discharge 15,000. H & H remained stable 12.1 and 35.4; Blood cultures-neg.	PUB	PUB	Toprol, HCTZ, Aleve, Centrum multi-vitamins, Celexa, estradiol, Ditropan, Zenical	NONE	Osteoarthritis, Exogenous obesity, history of Lyme disease dx'd in 1989, MI, Macula Degeneration.		CA000146	1						1	Asthenia; Difficulty in walking; Injection site erythema; Leukocytosis; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E71780LA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~468136~2~SC~LA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~U0343AA~3~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0164089	12/22/2000	ID	39.0	39		F	12/15/2000	The patient lost his voice, has a tickle in his throat, his neck feels tight, has a headache, generalized flushing, excessive coughing, and burning in the throat and the eyes.				Y					Y	12/08/2000	12/08/2000	0		OTH	PVT		NONE	NONE			1						1	Burning sensation mucosal; Cough; Eye pain; Flushing; Headache; Laryngitis; Throat tightness	FLU3~AVENTIS PASTEUR~U0453AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0164090	12/22/2000	VA	31.0	31		F		The patient is itching, has heaviness in the chest, wheezing, hives, and hot.				Y					Y	10/31/2000	10/31/2000	0	02 Sat 98%, Given Zantac, Solumedral, and Benadryl IV at the ER	PVT	PVT	Ventolin, Flovent, Proventil, ortho tri-cyclen, Prilosec, Phenergan		Allergies to several medications			1						1	Chest pain; Feeling hot; Pruritus; Urticaria; Wheezing	FLU3~MEDEVA PHARMA, LTD.~E65610HA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0164091	12/22/2000	UT	66.0	66		F	12/07/2000	The patient started with severe pain at pneumonia injection site, left arm.  Pain was in entire arm. elevated pain (like childbirth), stiff arm (like paralyzed), shaky body.  Patient could not move her arm.  About 1 - 2 hours later she took Ibuprofen, and the pain decreased.  The next day decreased appetite, decreased pain, nausea, faint, exhausted, sore arm, no redness or swelling.  Unable to lift arm, depression.  After 1 -2 days all okay except the patient had a sore arm.									Y	11/29/2000	11/29/2000	0	NONE	PUB	PVT	Vitamin, Ibuprofen	NONE	Tyroid Disease		UT002527	1						1	Decreased appetite; Fatigue; Injection site pain; Musculoskeletal stiffness; Nausea; Syncope; Tremor	FLU3~PFIZER\WYETH~4008181~2~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0710K~2~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0164092	12/22/2000	UT	36.0	35		F	10/02/2000	When titer testing was done in 1999 the pt was found to be a non-responder and was given 2 more Hep B shots. Approximately 1-2 weeks later she began tripping on her right foot. By 12/16/1999 her foot was noticeably flopping, and by the first of the year she couldn't lift her foot. He right calf muscle weakened and began to shrink. This weakness and atrophy moved up her leg into her thigh. She saw her PMD who referred her to an internal medicine MD who referred her to an orthopedic surgeon who then referred her to a neurologist. He diagnosed her with a viral infection and referred her to a Medical Center. Following an EMG she was diagnosed with ALS. The pt continues to have muscle weakness and atrophy in both legs. She has done some research and feels her problem may be related to the vaccine she received.				Y					N	12/02/1999	12/16/1999	14	EMG 4 times, Blood work, X-Rays, MRI 2 times, Cat Scan, Ultrsound, Myelogram	OTH	PVT	NONE	NONE	Migraines - 1 month		UT000622	1						1	Difficulty in walking; Muscle atrophy; Muscular weakness; Viral infection	FLU3~PARKDALE PHARMACEUTICALS~02979P~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~466785~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0164093	12/22/2000	TX	65.0	66		F	12/13/2000	The patient had skin redness, inflammation, and tenderness.									Y	12/05/2000	12/07/2000	2		PVT	PVT	MTX, Folic Acid, Toprol, Lotrel	Rheumatoid arthritis, Hypertension	Stadol			1						1	Erythema; Inflammation; Tenderness	FLU3~AVENTIS PASTEUR~U0415AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164094	12/22/2000	MN	40.0	40		F	12/14/2000	The patient had chils, temperature of 101, headache, muscle aches, weakness, fatigue for 2 1/2 days. Prescription: Ibuprofen and rest									Y	11/20/2000	11/20/2000	0	NONE	PVT	OTH	Multi Vitamin	NONE	NONE			1						1	Asthenia; Fatigue; Headache; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0164095	12/22/2000	ME	32.0	32		F	12/08/2000	The patient had a pneumo vaccination on Tuesday. On Wednesday her arm was sore and tender, called nurse first. Had a temperature of 101.6.  Thursday morning 2 inch area, Thursday evening it spread to a 4 inch area. Friday, 12/08/ 2000 large area on upper arm. The patient was put on Augmentin, no fever, extreme tenderness.				Y					N	12/05/2000	12/06/2000	1		PVT	UNK			Allergy - Ampicillin			1						1	Injection site pain; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E61760GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~10668K~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0164096	12/22/2000	FL	42.0	41		F	12/20/2000	Approximately 2 hours after vaccine was given , the patient complained of lightheadedness and upset stomach. Afebrile, denied any symptoms of adverse reactions.  On 12/14/2000, the employee called Employee Health stating she was ill and had not been able to work the afternoon of 12/12 or 12/13 due to R/O body aches, GI upset, redness, edema, and tenderness at the site of the injection. Employee seen on 12/14/2000 at 15:00 with redness of 3 inch by 4 inch and 2 inch by 2 inch edema at the left deltoid. On 12/20/2000 follow-up call to employee made, patient states feels fine, no redness, pea size knot at site, no GI disturbance. Instructed to call Employee Health or go to ER if any change. Symptoms of adverse reaction reviewed thoroughly with employee on 12/12, 12/14 and 12/20/2000.									Y	12/12/2000	12/12/2000	0	NONE	OTH	OTH	Tricor, Trinalin, Tagament, Afrin Nasal Spray, Tafranil, cellasene.	NONE	Allergic to Penicillin, Ampicillin, Darxon, Codein.	Stayed sick all winter~Influenza (Seasonal) (FluShield)~1~38.00~In Patient		1						1	Abdominal pain upper; Dizziness; Injection site erythema; Injection site nodule; Injection site oedema; Injection site pain; Malaise; Pain; Pyrexia; Similar reaction on previous exposure to drug	FLU3~PFIZER\WYETH~4008185~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164097	12/22/2000	OH	55.0	55		F	12/20/2000	The patient had body aches, chills, and a reddened area of the upper arm. On 12/19/00 the area was the size of a nickle that expanded to a 4 inch area. It was red and hot.  The patient was treated with antibiotics, then the patient had three reddened areas. The patient was told to put heat on it by the doctor.  Fever is gone, arm is sore but redness lightened took 10 days.				Y					Y	11/18/2000	11/19/2000	1	UNK	PUB	PVT	NONE	NONE	COPD			1						1	Chills; Injection site erythema; Injection site pain; Injection site warmth; Pain	FLU3~AVENTIS PASTEUR~U0439AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0946K~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0164098	12/22/2000	CA	42.0			M	12/05/2000	The patient is a health care worker (Physician) who experienced an onset of severe generalized headache, severe head to-toe myalgias and profound malaise with onset of 24-48 hours staus post influenza vaccine.  The patient has no medical history of note- headache was not positional, no hypersensitivity to light, no nausea, vomiting, or occular abnormality. No relief with Tylenol, Motrin or sleep. Onset head to-toe myalgias, no sore muscles. Muscles not painful to touch. No dark urine or stool color. The patient reports even  feel hurts him. Profound malaise, no stamina or endurance. The patient had to run a marathon and the severity of malaise exceeded the weakness S/P the marathon. Denies fever, cough, URTI, diarrhea. Triad of headache, myalgias and fatigue they all have lasted about 2 weeks.									U	11/16/2000	11/17/2000	1	Recent labs - wnl	UNK	UNK	Beconase, Triamcinolone		Allergies none, non-smoker, no medical problems			1						1	Asthenia; Headache; Malaise; Myalgia; Pain	FLU3~PFIZER\WYETH~4008173~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164125	12/27/2000	MA	81.0	81		M	11/17/2000	11/16/00, right deltoid was swollen. He said he felt feverish and applied ice to right deltoid. On 11/17/00 at 06:30, arm swelling dispersed, approx. 8 X 4, mild redness and swelling and soreness. Ice applied and took Tylenol previous night and morning. Swelling subsided by 11/20/00.									Y	11/16/2000	11/16/2000	0		PUB	PUB	Norvasc, atenolol, 1/2 adult aspirin	NONE	Hypertensive heart disease; allergy to pork and pollen		MA0018	1						1	Feeling hot; Injection site erythema; Injection site pain; Injection site swelling	FLU3~AVENTIS PASTEUR~U0435AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1217J~2~SC~RA~PNEUMO (PNEUMOVAX)~1|TD~MASS. PUB HLTH BIOL LAB~TD70~UNK~IM~RA~TD ADSORBED (TDVAX)~1	USA		Influenza
0164134	12/27/2000	NY	55.0	55		F		Received shot on 11/3/00 at 12:30 and on 11/5/00 at 23:00 became ill. Vision was blurred and then room began to spin to right, vomiting; symptoms repeated for 2 weeks. Dx'd with vertigo secondary to encephalitis in 1968.									Y	11/03/2000	11/05/2000	2		OTH	OTH	Caladryl, Serevent, Flovent, Atrovent		Staph in 10/2000; allergy to penicillin, asthma, hearing loss	Flu-like symptoms~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Vertigo; Vision blurred; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E68800KA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0164135	12/27/2000	OH	42.0	42		F	11/28/2000	Had severe reaction to flu shot and was down for 1 month. I called the health dept to report it but no one would believe me. I know several who also had reaction to shot. Flu shot stirred up my chronic bronchitis.									U	10/01/1998				UNK	UNK			Chronic bronchitis			1						1	Bronchitis chronic; Condition aggravated	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0164136	12/27/2000	CO	10.0	10		M	12/07/2000	Came in with weakness of lower extremities with paresthesias and loss of sensation following flu shot, 1 week prior.									U	11/12/2000	11/21/2000	9	Neurologist consultation; 2 Spinal Taps	UNK	UNK		NONE	Allergy to sulfa and Ceclor			1						1	Asthenia; Paraesthesia	FLU3~AVENTIS PASTEUR~U0409AA~6~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164137	12/27/2000	FL	18.0	18		F	12/06/2000	5-6  area on left upper arm and posterior shoulder with red, indurated papules with confluence; some small vesicles with erythema and induration. Treated with Benadryl lotion and Benadryl po.									U	12/02/2000	12/04/2000	2		PUB	PVT	Allegra				FL00051	1						1	Injection site erythema; Injection site induration; Rash papular	FLU3~AVENTIS PASTEUR~OU441AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164138	12/27/2000	FL	42.0	42		F	11/21/2000	On 11/10/00, flu vaccine given to right deltoid and pt had no problems at the time. She states that, 4 hours later, had pain to arm and felt heavy. On 11/16/00, continued to have pain which had increased along with limited ROM. Examined in clinic on 11/21/00 and referred for evaluation with worker's compensation doctor.				Y					U	11/10/2000	11/10/2000	0	NONE	PUB	OTH	NONE	NONE	NONE		FL00050	1						1	Injection site pain; Joint range of motion decreased; Sensation of heaviness	FLU3~AVENTIS PASTEUR~U0408DA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0164139	12/27/2000	KY	64.0	64		F		Received flu vaccine on 12/4/00. On 12/5/00, began experiencing swelling and pain in hands, feet, ankles and knees. Took Prednisone from 12/12/00 to 12/18/00 with relief, but symptoms returned on 12/21/00. Further follow-up pending.					Y				Y	12/04/2000	12/05/2000	1	NONE	PUB	PUB	Multivitamins, Toprol XL, Estratest, amitriptyline. Seroquel	NONE	Tardive Dyskinesia X 5 years; Hypertension; Hypercholesterolemia			1						1	Joint swelling; Oedema peripheral	FLU3~PFIZER\WYETH~4008175~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0164140	12/27/2000	NC	75.0	75		F	12/18/2000	Nausea and vomiting, chills and sweating, diarrhea, stomach cramps and pain, aching all over. Lasted about 3 days.									Y	12/01/2000	12/02/2000	1		PUB	OTH	NONE	NONE				1						1	Abdominal pain upper; Chills; Diarrhoea; Hyperhidrosis; Nausea; Pain; Vomiting	FLU3~PFIZER\WYETH~5008183~4~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164141	12/27/2000	MD	65.0	65		F	12/19/2000	Received influenza and pneumococcal vaccine in right deltoid, separated by 2 according to nurse, on 12/01/00. Pt complained of inability to use right arm due to pain within 4 hours of receiving vaccines. Seen by her doctor on 12/4/00. Treated with Medrol dose pack. Pt improved but still has pain. Has been seen by orthopedic doctors who told her if a nerve was affected it would take 6-8 weeks for improvement.				Y					Y	12/01/2000	12/01/2000	0		PUB	PUB	Amitriptyline, Atenolol, Fosamax	NONE	Depression, fibrillation			1						1	Hypokinesia; Pain	FLU3~MEDEVA PHARMA, LTD.~E64490HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1483J~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0164142	12/27/2000	HI	48.0	48		F	12/13/2000	Post vax, pt felt dizzy and nauseous. BP 120/80, pulse 60 beats per minute.									Y	12/13/2000	12/13/2000	0	NONE	PVT	PUB		NONE				1						1	Dizziness; Nausea	FLU3~PFIZER\WYETH~4008188~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164143	12/27/2000	HI	54.0	54		F	12/13/2000	Dizziness, feeling of nausea. Throbbing pain at immunization site, right upper arm and shoulder.									U	12/13/2000	12/13/2000	0	NONE	PUB	PUB		NONE				1						1	Dizziness; Injection site pain; Nausea	FLU3~PFIZER\WYETH~4008188~7+~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164144	12/27/2000	PA	74.0	74		F	12/14/2000	Acute illness 2 weeks, post vax, with rapidly progressive motor weakness peaking at 4-6 weeks and now recovering. Appears to be fairly classic, acute mild LGB syndrome. Pt had no other illnesses and temporal relationship to flu vaccine; makes this dx highly likely. First I've seen since 1977. Not fully recovered as yet.				Y	Y	4			N	10/20/2000	11/06/2000	17	EMg's-show diffuse polyneuropathy; CSF-81mg protein, 100 lymphs	OTH	OTH	Synthroid, Lopid	NONE	History of remote colon cancer (>20 years), hypothyroidism, hypertriglyceride			1						1	Guillain-Barre syndrome; Hypokinesia; Laboratory test abnormal; Lymphocytosis; Polyneuropathy	FLU3~EVANS VACCINES~E65630HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0164145	12/27/2000	MA	12.0	12		F		Swollen arm, dizziness, weak, body aches, fever, vomiting and stomach ache.									Y	12/02/2000	12/03/2000	1		PUB	UNK	NONE	NONE	History of asthma		MA0019	1						1	Abdominal pain upper; Asthenia; Dizziness; Injection site swelling; Pain; Pyrexia; Vomiting	FLU3~AVENTIS PASTEUR~U0443AA~6~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164146	12/27/2000	MA	49.0	49		F	12/14/2000	Client received injection at 08:35 on 12/13/00; called nurse at 08:50 complaining of rash all over, pink on face, pinpoint spots on arms, stomach and chest red. Also complaining of itchiness. Improving. Referred to MD for ? Rx and to check rash. Denies temperature.				Y					Y	12/13/2000	12/14/2000	1	NONE	PUB	PUB	Claritin and depression medications	NONE	Allergic to dust mites, mold and pollen.		MA0016	1						1	Erythema; Pruritus; Rash	FLU3~AVENTIS PASTEUR~U0403AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0164147	12/27/2000	MA	66.0	66		F	11/28/2000	Pt was seen by physician 3 days post vax. Pt complained of tenderness and redness.  Area hot to touch. Pt was encouraged to call MD and seek treatment for cellulitis, which she did. Pt was treated with antibiotics.				Y					Y	11/18/2000	11/20/2000	2		PUB	PUB	Lorazepam, Zestril, Glucophage	NONE	NONE		MA0014	1						1	Cellulitis; Injection site erythema; Injection site pain; Injection site warmth	FLU3~AVENTIS PASTEUR~UO403AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0164148	12/27/2000	MD	84.0	84		F	12/20/2000	Client had itching at injection site 3-4 days and later in the week, the itching increased and was red. Had 2 blisters. Scratched 1 at injection site and the 2nd one was 1 away. Called and spoke to nurse at health dept. Used cortisone locally and it went away in several weeks. Has occasional itching at site since then. She left message at her doctor's but did not speak to or see physician.									Y	10/30/2000	11/02/2000	3		PUB	PUB	Prevacid, Lipitor, Vasotec, Glipizide, Alphagan eye drops, Betagan, Xalatan, Pred-Forte, Gen Teal, Chlord/clid,	NONE	Allergy to codeine, penicillin and sulfa; NIDDM, Glaucoma, (corneal transplants).			1						1	Blister; Injection site erythema; Pruritus	FLU3~MEDEVA PHARMA, LTD.~E64330HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0164149	12/27/2000	FL	63.0	63		F	12/07/2000	Chills, body aches and poor appetite for 3 to 4 days.				Y					Y	11/30/2000	12/01/2000	1	Tests ordered 12/7/00; results not available	PUB	UNK	spironolactome, Lisinopril, Pepcid, Lasix, Synthroid	NONE	Hepatitis C w/o liver cirrhosis, hypothyroidism, chronic thrombocytopenia and neutropenia, splenomegaly			1						1	Chills; Oral intake reduced; Pain	FLU3~AVENTIS PASTEUR~U0435AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0164151	12/27/2000	MA	67.0	67		F	11/30/2000	Left arm very swollen, hot, tender, erythematous with nausea, no vomiting.									Y	11/28/2000	11/28/2000	0	NONE	PUB	PUB	NONE	NONE			MA0015	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Nausea	FLU3~AVENTIS PASTEUR~U0417AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~472210~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0164158	12/28/2000	AZ	72.0	72		M	12/19/2000	Death within 48 hours, post vax; Myocardial Infarction.	Y	12/15/2000							N	12/13/2000	12/15/2000	2	NONE	PVT	PVT	K-Dur, bumetanide, nitroglycerine, Zeroxin, Lipitor, Azmacort, Atrovent	NONE	CAD; Chronic CHF			1						1	Myocardial infarction	FLU3~AVENTIS PASTEUR~U0453AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0164159	12/28/2000	GA	81.0	81		F	12/20/2000	None reported.	Y	12/07/2000							N	11/30/2000				OTH	PUB		UNK	CAD			1						1	Unevaluable event	FLU3~AVENTIS PASTEUR~U0435AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0164164	12/28/2000	NJ	18.0	18		M	12/18/2000	Pt received yellow fever and flu vaccines and 30 minutes later, developed urticaria and shortness of breath, prompting evaluation and treatment at MD's office. Received Epinephrine and Benadryl IM X1 and IVF (NSS X 1L).			Y	Y					Y	12/18/2000	12/18/2000	0		MIL	MIL	NONE	NONE	Allergy to PCN			1						1	Dyspnoea; Urticaria	FLU3~PFIZER\WYETH~4008210~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|YF~CONNAUGHT LABORATORIES~UA228AA~1~SC~~YELLOW FEVER (YF-VAX)~1	USA	Life Threatening	Influenza
0164192	12/28/2000	CA	52.0	52		F	12/07/2000	Vomiting from upset stomach, bad headache and weak.									N	12/05/2000	12/06/2000	1	NONE	OTH	UNK	Around 10 Rx'd drugs	NONE	Sinus allergy; allergy to Penicillin			1						1	Asthenia; Headache; Stomach discomfort; Vomiting	FLU3~PFIZER\WYETH~4008180~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164193	12/28/2000	TX	62.0	62		F	11/20/2000	Less than 12 hours, post vax, pt began aching over whole body, severe shaking, fever 100F (orally) and chest hurting. Severe local reaction with redness and swelling from site spreading 11cm X 8cm down left arm to where small 1cm X 4cm blister appeared. Pt also states that fever blister appeared around same time as blister on her arm. She was referred to MD.				Y					N	11/15/2000	11/15/2000	0		PUB	PUB	Prednisone, cyclobenzaprine, Zocor, hydrocodone	NONE	Polymyalgia Rheumatica		TX00163	1						1	Blister; Chest pain; Herpes simplex; Injection site erythema; Injection site swelling; Pain; Pyrexia; Tremor	FLU3~AVENTIS PASTEUR~U01410AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0164194	12/28/2000	SC	31.0	31		F	11/09/2000	At 14:10, client has 4cm X 4cm swollen area with scant redness. Ice pack applied. No abnormal signs or symptoms of anaphylaxis.									Y	11/09/2000	11/09/2000	0		PUB	PUB	Bactrim	Infection	Taking Bactrim for infection.		SC00086	1						1	Injection site erythema; Injection site swelling	FLU3~AVENTIS PASTEUR~U0417AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164195	12/28/2000	PA	50.0	50		F	12/21/2000	Fluzone given IM left deltoid, temperature 98.6F, on 10/31/00, at 11:00. On 11/1/00, localized reaction at injection site with wheal 130mm diameter; red and warm. No medication needed. Duration of 4-5 days with complete recovery.									Y	10/31/2000	11/01/2000	1		OTH	PVT	Calan, Detrol, Premarin, Proventil	NONE	Allergic to Novocaine Iodine Sulfa; HTN; Asthma			1						1	Injection site erythema; Injection site warmth; Urticaria	FLU3~AVENTIS PASTEUR~U0345AC~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164196	12/28/2000	WI	23.0	23		F	12/14/2000	Pt seen on 12/1/00 with swollen, red, very tender left shoulder and fever.				Y					U	11/28/2000	11/30/2000	2	WBC-16,900 (inc)	PVT	PVT	Prednisone, birth control pills, ibuprofen	NONE	Allergy to Ceclor and Rocephin			1						1	Injection site erythema; Injection site pain; Injection site swelling; Pyrexia; White blood cell count increased	FLU3~AVENTIS PASTEUR~U0434AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~470588~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0164197	12/28/2000	MI	50.0	50		F	11/06/2000	Pt states had burning at time of injection and within 20 minutes, had itching at elbow. At 11:20, itching at site of injection and down to elbow. Area around site was reddened.									Y	11/06/2000	11/06/2000	0	NONE	PUB	PUB	UNK	NONE	UNK		MI2000094	1						1	Injection site erythema; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~4008173~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164198	12/28/2000	MI	83.0	83		F	11/19/2000	Vaccine given at 10:30 and 2 hours later, pt experienced perspiration, unable to get up from chair and nausea. Taken to hospital by EMS.				Y					Y	11/08/2000	11/08/2000	0	EKG, Blood drawn	PUB	UNK	UNK	NONE	UNK		MI2000095	1						1	Abasia; Hyperhidrosis; Nausea	FLU3~PFIZER\WYETH~4008173~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0164199	12/28/2000	MI	43.0	43		F	12/21/2000	Called on 12/14/00 to report that 45 minutes, post vax, on 12/15/00, pt experienced an episode of vertigo, feeling warm and perspiring, momentarily, with weakness and fatigue for 1 hour following episode.									Y	12/13/2000	12/13/2000	0	NONE	PUB	UNK		NONE	NONE			1						1	Cachexia; Fatigue; Feeling hot; Hyperhidrosis; Vertigo	FLU3~AVENTIS PASTEUR~U0454AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164200	12/28/2000	AK	41.0	41		F	12/21/2000	Reaction at injection site only; next day, swelling, hard, white with red border, very painful. White and pain diminished in 1 week; redness 2 diameter, 3 weeks later (down from 3 hard diameter). Almost gone.									N	11/29/2000	11/29/2000	0	NONE	OTH	PVT	NONE		NONE			1						1	Injection site erythema; Injection site induration; Injection site swelling; Rash	FLU3~PFIZER\WYETH~4008180~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164201	12/28/2000	MO	55.0	55		F	12/19/2000	That night, post vax, she woke up 3 times with numbness and pain in left arm from fingertips to elbow. Right arm was also affected on the 3rd awakening. Continues to have soreness at site.									N	12/12/2000	12/13/2000	1		OTH	UNK	Prozac, Prempro	NONE	Allergy to sulfa; anxiety disorder			1						1	Hypoaesthesia; Injection site pain	FLU3~AVENTIS PASTEUR~U0454AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164202	12/28/2000	PA	43.0	43		F	12/22/2000	Post vax, pt developed redness, swelling and tenderness at injection site. Seen in ER at 15:14 and received Benadryl and Solu-Medrol IV. Was told to take Benadryl 25-50 mg every 4-6 hours at home. On 12/21/00, seen by MD and face was flushed. Rx given for prednisone.				Y					Y	12/20/2000	12/20/2000	0		PUB	PVT	Neurontin, Celebrex	NONE	Allergies to inhalants and bees. Also, 2 to 3 years ago, had an anaphylactoid reaction to allergy shots.			1						1	Flushing; Injection site erythema; Injection site pain; Injection site swelling	FLU3~PFIZER\WYETH~4008202~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0164203	12/28/2000	NM	52.0	52		M		Pt complained of low back pain, beginning 3 hours, post vax. No fever, rashes, nausea or vomiting or any other myalgias. No radiation of pain, no bowel or bladder or other weakness.				Y					U	12/18/2000	12/18/2000	0	LS Spine films-Disc narrowing at L5-S1	OTH	OTH	NONE	Low back pain	Penicillin allergy			1						1	Back pain; Cartilage development disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0164204	12/28/2000	MO	50.0	50		F	12/20/2000	Pressure on chest (very heavy), trouble breathing, temperature 101F, eyes were bloodshot and muscle hurt all over; started about 19:00 on 12/11/00 until about 10:00 on 12/12/00. Muscles still hurt some on 12/12/00. Took aspirin and warm bath helped some.									Y	12/11/2000	12/11/2000	0		PUB	PUB	NONE	NONE	NONE			1						1	Chest discomfort; Dyspnoea; Myalgia; Ocular hyperaemia; Pyrexia	FLU3~AVENTIS PASTEUR~U00454AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164205	12/28/2000	CA	64.0	64		M	12/18/2000	Prolonged coughing, wheezing, dizziness, 2 X normal heart rate and sweating.				Y					Y	11/07/2000	11/30/2000	23	X-rays-nml	OTH	PUB	Insulin, Glipizide, atenolol, Univasc, Hydrochlorathiazide, Tylenol with codeine	Slight cough	Diabetes, Hypertension, ruptured disc	Flushed and nauseated~Influenza (Seasonal) (no brand name)~~63.00~In Patient		1						1	Cough; Dizziness; Heart rate increased; Hyperhidrosis; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0164206	12/28/2000	SC	39.0	39		F	12/18/2000	Early afternoon, had headache, tired, generally blah feeling. Mid-late afternoon, took aspirin but felt progressively worse. By evening/night, very sore on left side, painful to breathe or move (left side only). Early Saturday morning, had huge painful swelling to left axillary area that lasted 3 days.									Y	12/01/2000	12/01/2000	0		OTH	PUB	Claritin, Loestrin	NONE	Allergy to Penicillin, sulfa, trees, grasses/weeds, mold, cat dander and dust.			1						1	Fatigue; Feeling abnormal; Headache; Hypokinesia; Pain; Swelling	FLU3~AVENTIS PASTEUR~U0439DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164207	12/28/2000	FL	26.0	26		F	12/18/2000	Post vax, had flu/cold-like symptoms for over a week with sneezing, coughing, headaches, low-grade fever, stuffy head, tired and just sore all over.									Y	12/06/2000	12/08/2000	2	NONE	PUB	PVT	Levothroid, Zyrtec	NONE	Allergy to codeine and novocaine			1						1	Cough; Fatigue; Headache; Influenza like illness; Nasal congestion; Pain; Pyrexia; Sneezing	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0164208	12/28/2000	VA	53.0	53		M	12/21/2000	Post vax, had local swelling at injection site with slight light-headedness. Given Benadryl 25mg and observed for 30 minutes. Also, used ice pack.									Y	12/21/2000	12/21/2000	0		PVT	UNK	Lipitor 20mg	NONE				1						1	Dizziness; Injection site swelling	FLU3~MEDEVA PHARMA, LTD.~E71300LA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0164209	12/28/2000	CO	21.0	21		F	12/06/2000	This was pt's 1st flu shot so we requested that she wait 20 minutes, which she did, without incident. Within another 15-20 minutes, she returned complaining of itching, red, blotchy right arm and right neck and a scratchy throat. She was give Epinephrine SC and observed for approx. 30 minutes. Itching was relieved but felt weird. Advised this was usual reaction to Epi and call back with complaints or see MD or ER if warranted. Called feeling nauseous and sent to ER where something to slow my heart was given and pt was feeling better and sent home.				Y					Y	12/06/2000	12/06/2000	0		PUB	PUB		Itching, tight throat	Allergic to sulfa and codeine (anaphylaxis)			1						1	Feeling abnormal; Heart rate increased; Injection site erythema; Nausea; Pharyngolaryngeal pain; Pruritus; Rash macular; Throat tightness	FLU3~AVENTIS PASTEUR~U0415AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0164210	12/28/2000	MI	37.0	37		F	12/23/2000	Really sore arm, shortness of breath, sharp stomach pains, light-headed, headache, slight fever, extremely weak, upset stomach, diarrhea and hurt all over (shoulders hurt the most).									Y	12/19/2000	12/19/2000	0		PVT	PVT	Thyroid supplement	NONE	Migraines, thyroid disorder			1						1	Abdominal pain; Asthenia; Diarrhoea; Dizziness; Dyspnoea; Headache; Injection site pain; Pain; Pyrexia; Stomach discomfort	FLU3~PFIZER\WYETH~4008221~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164211	12/28/2000	IA	71.0	71		F	12/19/2000	Pain from time of treatment for a week. Bruise the size of a quarter for 2 1/2 weeks. Redness and hardness in muscle for 2 weeks. Fever of 100.9F for 2 days and couldn't sleep for the first 3 nights on right arm.									Y	11/27/2000	11/27/2000	0		PUB	PUB	Triam/HCTZ	NONE				1						1	Injection site erythema; Injection site haemorrhage; Injection site induration; Injection site pain; Pyrexia; Sleep disorder	FLU3~PFIZER\WYETH~4008181~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0690K~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0164212	12/28/2000	OH	45.0	55		F	12/21/2000	Muscle aching, chills, dyspepsia, headache and stiff neck. Achiness in arms and hands to where she could not grip. Consulted chiropractor on 12/16/00, MD on 12/18/00 and Massage Therapist on 12/20/00. By 12/21/00, symptoms eased.				Y					Y	12/08/2000	12/11/2000	3	NONE	PUB	PUB	Paxil, Fosamax, Estrogen Patch	NONE	Allergy to cats			1						1	Chills; Dyspepsia; Headache; Muscular weakness; Musculoskeletal stiffness; Myalgia	FLU3~AVENTIS PASTEUR~U0417AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0164213	12/28/2000	OH	64.0	64		M	12/19/2000	Temperature normal and tired from working 8 hours. Seems like a fast heartbeat that lasted 1 hours. Felt bad for about 6 hours. Took Tylenol.									Y	12/13/2000	12/15/2000	2		PUB	PVT	Pepcid, Lipitor, Dyazide, allopurinol, metoprolol, Cardura					1						1	Fatigue; Feeling abnormal; Heart rate increased	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0164214	12/28/2000	PA	26.0	26		F	12/20/2000	About 3 hours, post vax, she became nauseated and vomited while at work (40F at assembly line); 15 minutes after vomiting, she returned to assembly line and felt faint and passed out for 15 minutes. Became conscious, answered questions appropriately to ER.				Y					Y	12/18/2000	12/18/2000	0	Serum pregnancy test-neg; EKG-nml; Blood sugar-116; electrolytes and renal function-both nml; O2 saturation-99%	OTH	PVT	NONE	Dizzy spells, occasionally	NONE			1						1	Dizziness; Loss of consciousness; Nausea; Vomiting	FLU3~PFIZER\WYETH~4008216~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0164215	12/28/2000	OH	60.0	60		F	12/07/2000	Arm swollen and red with red blotches extending to axilla. Axilla painful; no fever. Doctor felt it was infected and placed on antibiotics. Improved.				Y					Y	12/04/2000	12/05/2000	1		PUB	PUB	HTN medicines, Thyroid medicines, Vioxx and Premarin	NONE	Allergies to wheat, Vistaril, Demerol, Sulfa Cream		ND0019	1						1	Injection site erythema; Injection site infection; Injection site pain; Injection site swelling; Rash macular	FLU3~MEDEVA PHARMA, LTD.~E73110LA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1197K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0164216	12/28/2000	OH	66.0	66		M	12/07/2000	Developed fever, vomited X 1, weak, aching all over with swelling on left arm 4 X 5 area and very sore. Doctor seen and he felt it was infected. Red streaks on arm. Was placed on antibiotics. Improving.				Y					Y	12/04/2000	12/04/2000	0		PUB	PUB	Thyroid medications	Mild cold symptoms	Allergy to codeine.		ND0018	1						1	Asthenia; Cellulitis; Injection site infection; Injection site swelling; Pain; Pyrexia; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E73110LA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1197K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0164217	12/28/2000	SC	66.0	66		F	12/12/2000	Vomiting, diarrhea and stiffness in joints.									Y	11/29/2000	11/30/2000	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Diarrhoea; Joint stiffness; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E62670GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~473355~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0164219	12/28/2000	TX	35.0	35		M	12/26/2000	Achy joints, feeling very hot, nasal drainage, sneezing, coughing, sore throat and weak, started on 12/25/00. On 12/26/00, symptoms were slightly better; dry lips.									N	12/23/2000	12/25/2000	2		OTH	PVT		NONE	ASA			1						1	Arthralgia; Asthenia; Cough; Dry mouth; Feeling hot; Pharyngolaryngeal pain; Rhinorrhoea	FLU3~PFIZER\WYETH~4008205~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164220	12/28/2000	ME	28.0	28		F	12/26/2000	Pt presents to office 24 hours, post vax, with 25mm erythema, hardness and warm to touch. Pt tired and achy.				Y					Y	12/21/2000	12/22/2000	1		PVT	PUB	BCP, multivitamins and TB/LFA/12/11/00-1st one given by WorkMed; 2nd TB/RFA/12/18/00-given by WorkMed	Fatigue and body aches	Allergy testing done-2000			1						1	Fatigue; Injection site erythema; Injection site induration; Injection site warmth; Pain	FLU3~AVENTIS PASTEUR~U0465AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0164221	12/28/2000	CA	45.0	45		F	12/08/2000	Post vax, pt experienced symptoms of bitter taste in mouth, fever/chills and sore arm with swelling.									Y	12/05/2000	12/05/2000	0		PUB	PUB	theophylline, prednisone		Asthma		CA000143	1						1	Dysgeusia; Injection site pain; Injection site swelling; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E7170LA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0164222	12/28/2000	CA	52.0	52		F	11/29/2000	Pt developed flu-like symptoms, the evening, post vax. Her left arm gradually started going numb on and off with tingling sensations. She reported chest pain and back pain (both have subsided). She also had pain in her left arm, as well as soreness. She said that there was a scab where the needle was inserted, even a few weeks after she had the injection. Currently, her left arm is having numb sensations on and off.				Y					N	11/06/2000	11/06/2000	0		PUB	PUB	UNK	NONE	Diabetes	Arm became hot, red, swollen and she felt like fainting~Influenza (Seasonal) (no brand name)~~46.00~In Patient	CA000142	1						1	Back pain; Chest pain; Hypoaesthesia; Influenza like illness; Injection site pain; Scar	FLU3~MEDEVA PHARMA, LTD.~E67380KA~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0164223	12/28/2000	CA	73.0	73		M	11/28/2000	Individual contacted to report a very sore arm starting the day after vaccination. He said that he could barely lift his arm. He denied any other symptoms but said his arm has not been improving (it had been sore for 11 days on the day of report). He had not seen a doctor for these symptoms, but was planning to. He reported minor arm soreness from previous flu vaccinations, but he said it was nothing compared to what he is feeling after this vaccine.									N	11/17/2000	11/18/2000	1		OTH	PUB	UNK	NONE	NONE		CA000141	1						1	Hypokinesia; Injection site pain	FLU3~MEDEVA PHARMA, LTD.~E67380KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0164232	12/28/2000	CT	34.0	34		F	11/15/2000	Increased chest pain, itchy at sight of injection without diaphoresis or SOB or dizziness, nausea or vomiting. Pt was sent to ER. Gave pt 0.3ml 1:1000 epinephrine SC in the right arm. Incident occurred 10 minutes after vaccine given. In follow-up, dated 12/18/00, this pt did spend the night at the hospital but was assured that the vaccine had no relationship to the chest pain.				Y	Y	1			U	11/15/2000	11/15/2000	0		OTH	PUB		NONE	Asthma, Obesity, Depression			1						1	Chest pain; Injection site reaction; Pruritus	FLU3~MEDEVA PHARMA, LTD.~E59090GA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0164242	12/28/2000	CO	41.0	41		F	12/19/2000	The patient felt feverish right after her shot, but it passed. Then about 8 hours later she became very feverish, difficulty breathing, fast heart beat, and hives. The patient felt okay by the next morning.									Y	12/04/2000	12/04/2000	0		OTH	PVT						1						1	Dyspnoea; Heart rate increased; Pyrexia; Urticaria	FLU3~PFIZER\WYETH~4008181~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0162215	12/29/2000	CT	36.0			F	11/27/2000	Broke out with red blotches on 3rd morning, post vax. Took to hospital and was given Benadryl and prednisone , lasted for 1 week. She was told that there was neomycin and polymycin in this batch and she is allergic to PCN! She has taken the flu shot for the last 8 years with no reaction.				Y					Y		11/05/2000			PUB	UNK	Keppra		Allergy to PCN, Bactrim, cephlosporins; TiB due to car accident			1						2	Oedema peripheral; Rash macular; Urticaria; Rash macular	FLU3~MEDEVA PHARMA, LTD.~E67940KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~~7+~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0164273	12/29/2000	TN	74.0	74		M	12/19/2000	Took 2 shots in same arm about 1/2 apart. I went home and laid down. About 4 hours, my arm began to swell. It (the place where shot was given) was about the size of a baseball. The next morning, about 07:30, my arm was about 3 times as big. Still have effects. Missing vaccine information not available.			Y	Y	Y		Y		U	11/29/2000	11/29/2000	0		OTH	OTH	NONE	UNK	NONE			1						1	Hypersensitivity; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~071810CA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~007101C~UNK~SC~LA~PNEUMO (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0164278	12/29/2000	WI	41.0	41		F	12/01/2000	Pt comes in because of numbness on the bottom of her feet, distal and buttocks. Onset this evening, post vax, flu shot. Dx'd with probable flu shot reaction, non-allergic. Did offer some anti-histamine with Claritin for 7 days to blunt the symptoms. If she gets any further symptoms, she will call. Now her symptoms over the last 48 hours are beginning to progress in the left leg as well. She is having a hard time ambulating due to discomfort. She has some difficulty with walking on her heels. There is an apparent element of a sensory ataxia. Possible inflammatory polyradiculoneuropathy. Her progression has been slow, although I think that it would be prudent to begin IV gamma globulin in this context. Consult with another MD and he agrees that most likely it is a radiculopathy from spinal narrowing, possibly spinal stenosis.					Y				U	11/13/2000	11/13/2000	0	MRI-neg; LP-pending; CBC-nml; Differential-nml; Sed rate-7; Chemical panel pending	PVT	PVT	Tenormin, Premarin, Singulair, ocular steroid therapies	NONE	Mitral Valve prolapse; asthma; uveitis; history of hysterectomy in 1994 for treatment of endometriosis; bilateral salpingo-oophorectomy at that time as well; she has had eye surgery for lazy eye; had appendectomy and tonsillectomy; cataract extraction and IOL			1						1	Bone disorder; Coordination abnormal; Hypersensitivity; Hypoaesthesia; Pain; Polyneuropathy; Sensory disturbance	FLU3~AVENTIS PASTEUR~U0415AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0164291	12/29/2000	IN	48.0	48		F	12/18/2000	Evening after shot had soreness  with warm to touch area below where vax was given. Slight stomachache and diarrhea below 12/18/2000 only. Today has right triangular area 4 x 31/2 below deltoid bruising no swelling or warmth.									Y	12/08/2000	12/08/2000	0		OTH	OTH		NONE	Asthma, Hypertension, Diabetes, Sinus, Lactose Intolerence			1						1	Abdominal pain upper; Diarrhoea; Injection site haemorrhage; Injection site pain; Injection site warmth	FLU3~AVENTIS PASTEUR~U0454AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164292	12/29/2000	OH	82.0	82		F	12/16/2000	Headache, face hot, eyes red almost blood shot, heart beat fast & some dizziness, choking feeling in my esophagus (at first a metallic taste after shot.) Instructed to take Tylenol									Y	12/04/2000	12/04/2000	0		PUB	UNK		NONE	Had laser treatment			1						1	Choking; Dizziness; Dysgeusia; Headache; Heart rate increased; Ocular hyperaemia; Skin warm	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0164293	12/29/2000	IL	80.0	80		F	12/19/2000	Generalized micro papular rash, sparing the hands and feet 12-14 hours after vaccine administration prulitic lower extremities, resolved after 6 days.									Y	12/12/2000	12/12/2000	0	CBC -normal	PVT	PVT	ASA 81mg qd. Norrasc 5mg qd, HCTZ 25mg QD	NONE	NONE			1						1	Pruritus; Rash maculo-papular	FLU3~PFIZER\WYETH~4008195~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164294	12/29/2000	CA	73.0	73		F		Vaccination 11/16/2000. Symptoms on set sudden about 30 minutes after on 11/17/2000. Sore throat, dry cough, chills runny nose. On 11/20/2000 Both knee joints. Medication Tylenol, Robatussin cough, nose spray and Augmentin				Y					Y	11/16/2000	11/17/2000	1		PUB	UNK						1						1	Arthralgia; Chills; Cough; Pharyngolaryngeal pain; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0164295	12/29/2000	NY	45.0			F	12/18/2000	Five minutes post vax, I became dizzy light headed, nauseous. My upper arms and chest area became chilled and I felt I was slipping away or about to faint. I recovered about 15 minutes later but this effect kept coming in waves for the next 4 hours, lasting aprox 15 minutes each. My stomach has been upset to date. Also nausea and inability to eat normally.									N					PVT	UNK		NONE	Allergic to Penicillin, erythromycin, aspirin			1						1	Anorexia; Chills; Dizziness; Nausea; Stomach discomfort; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0164296	12/29/2000	MA	36.0	36		F	12/11/2000	Immediate reaction in left arm - very sore upon administration. Left arm felt weak down to hand, was given @ 11:00 at 7:00 pm body shakes, chills 9:00 pm, 3:00 am temp 100.3 - fever, chills, headache all night woke up afebrile.									Y	12/06/2000	12/06/2000	0	N/A	PUB	UNK		NONE	NONE			1						1	Asthenia; Headache; Injection site pain; Pyrexia; Tremor	FLU3~AVENTIS PASTEUR~U0441AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164297	12/29/2000	NY	53.0	53		F	12/20/2000	About 4 hours post vax, I became itchy on my face head, neck went to the hospital. MD said I had the hives, he put me on Benadryl and hives went away after 4 - 5 days of Benadryl.				Y						11/30/2000	12/01/2000	1		PUB	UNK						1						1	Pruritus; Urticaria	FLU3~PFIZER\WYETH~4008173~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0164298	12/29/2000	TN	39.0	39		F	12/27/2000	A 39 year old pharmacist reported that she received an influenza vaccine on 11/30/00 and subsequently developed premature ventricular contractions. On 12/11/00 she was seen by the physician. An electrocardiogram was reportedly positive for premature ventricular contractions. The reporter noted that she did not have any other symptoms or has not experienced premature ventricular contractions prior to this. The event is considered medically important.				Y					U	11/30/2000	12/11/2000	11	EKG-premature ventricular contractions on 12/11/00	OTH	OTH	NONE	NONE	UNK		4801013	1						1	Ventricular extrasystoles	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0164299	12/29/2000	SD	21.0	21		F		Pt had local reaction at site of injection, erythema, itching									Y	12/13/2000			NONE	MIL	MIL		NONE	Sulfa			1						1	Injection site erythema; Injection site hypersensitivity; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0164300	12/29/2000	CA		55		F	12/19/2000	Pt was given 1/4 dose on 12/4/2000. Began with chest heaviness 2 hours post vax referred to ER not related to vax, given 2nd 1/4 dose today called in 1 hour later again felt heaviness and sis take Benadryl q 4-6 hours x 24 hours Felt better in 1 hour.				Y					Y	12/19/2000	12/19/2000	0		PVT	PVT			Codeine, PCN, ASA, Keflex and sulfa			1						1	Chest pain	FLU3~PFIZER\WYETH~4008180~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0164301	12/29/2000	WA	72.0	72		F	12/18/2000	Swelling and pain at injection site, generalized malaise, chills, aches, lymphadenopathy, left axilla									U	12/12/2000	12/13/2000	1	NONE	PVT	UNK	NONE	NONE	NONE			1						1	Chills; Injection site oedema; Injection site pain; Lymphadenopathy; Malaise; Pain	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164302	12/29/2000	CA	44.0	43		M	11/30/2000	Tingling of fingers and slight temp 99-100.				Y					Y	11/16/2000				UNK	UNK						1						1	Paraesthesia; Pyrexia	FLU3~AVENTIS PASTEUR~U0416BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0164303	12/29/2000	TX	60.0	60		F	12/07/2000	Left arm became swollen, sore to touch pm of injection, next day swollen to elbow, red and more painful. Treated with Augmentin				Y					Y	12/06/2000	12/06/2000	0	NONE	PUB	PUB	Atalac , Vasotec, Procardia , Zocor	NONE	Sulfa		TX00166	1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4008182~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0690K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0164304	12/29/2000	NY	73.0	73		M	12/27/2000	10/18/2000 Next morning post shot pts joints painful, hands swelled, hot and red. Suffered until11-27. Visited Rhuematologist got arthritis medication. Quickly pain subsided and swelling, redness relieved after 2 days could walk and work again without pain.				Y					U	10/18/2000	10/19/2000	1	X-rays - blood tests	MIL	OTH	Topril, zocor, Ecotrin, flomax					1						1	Arthralgia; Erythema; Feeling hot; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0164315	01/02/2001	MA	11.0	11		F	12/07/2000	Pt developed fever and rash, 4 weeks, post vax, with increased respiratory difficulty; by the 5th week,requiring assisted ventilation.  Diagnosed with Varicella pneumonia				Y	Y	14			Y	10/19/2000	11/21/2000	33	Increased LFT's, decreased platelets	PVT	PUB	zantac, albuterol neb., intal meb.	congenital CMV, CP, RAD	Congenital CMV, CP, RAD, developmental delay, legally blind			1						1	Hypoxia; Liver function test abnormal; Platelet count decreased; Pyrexia; Rash; Respiratory distress	FLU3~AVENTIS PASTEUR~U0346AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0538K~1~IM~RL~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0164316	01/02/2001	MN	47.0	47		F	12/22/2000	The pt experienced an asthma attack, difficulty breathing, brought under control with repeated doses of albuterol inhaler.			Y						Y	12/01/2000	12/01/2000	0		PVT	OTH	Singulair, Pepcid, Beclovent, Serevent, Vancenase AQ	NONE	Asthma; benign arachnoid cyst in brain			1						1	Asthma; Dyspnoea	FLU3~PFIZER\WYETH~4008195~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening	Influenza
0164324	01/02/2001			47		F	12/20/2000	This patient received the flu vaccine in the left deltoid 11/12/2000.  Two days later at the injection site erythematous raised papules appeared, then two weeks later sub Q hematoma 0.5 cm with erythematous papules came and pustules appearing sub Q fluid in concealed collection. Minimal treatment: 4 erythematous raised tender papules 0.2-0.4 cm in size with pustular appearing central area.									U	11/13/2000	11/15/2000	2		UNK	UNK			Diabetes Mellitus, COPD, Native American.			1						1	Injection site erythema; Rash papular; Rash pustular; Tenderness	FLU3~MEDEVA PHARMA, LTD.~E67400KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0164325	01/02/2001		42.0			M	12/05/2000	This health care worker (physician) experienced an onset of severe unremitting generalized headache, severe head to-toe myalgias, and profound malaise after 24-48 S/P influenza vaccine. The patient has no medical history of note - headache was not positional, hypersensitivity to light, no nausea, vomiting or occular abnormality. No relief with Tylenol. Motrin or sleep. Onset severe myalgia, no muscles spared.  Muscles not painful to touch.  No dark urine or stool color. Patient reports even feel hurts him.  Profound malaise, no stamina or endurance. The patient had to run a marathon and the severity of malaise exceeded the weakness S/P the marathon. Denies fever, cough, URTI, and diarrhea.  Triad of headaches, myalgias, and fatigue lasted approximately 2 weeks.									U	11/16/2000	11/17/2000	1	Recent labs-wnl	UNK	UNK	Beconase, Triamcinolone		No allergies, non-smoker,no medical problems			1						1	Asthenia; Headache; Malaise; Myalgia; Pain	FLU3~PFIZER\WYETH~4008173~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164326	01/02/2001	MA	48.0	48		F	12/21/2000	The patient received her vaccine a 10:30 AM. At 11:30 AM the patient presented to nurse with a mild itchy rash to neck and chest.  Progressed rapidly to shortness of breath. The nurse conducted an assessment and treatment was offered and excepted by the patient for an allergic reaction. The patient was injected with Epinephrine and all was called.  When the paramedics arrived the patient was still having breathing trouble.  They transported the patient to the ER a 11:45. Discharge from the hospital at 3:30.  In the evening followed-up with the patient and the patient responded that she was tired but otherwise okay.				Y					Y	12/18/2000	12/18/2000	0		PUB	PVT		NONE	NONE			1						1	Dyspnoea; Fatigue; Hypersensitivity; Pruritus; Rash	FLU3~AVENTIS PASTEUR~UA457AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0164327	01/02/2001	MD	64.0	69		F	12/19/2000	The patient had an occurance of vertigo 57 hours after the flu vaccine was administered.  Vertigo still present as of 12/19/00, but improved. Large local reaction on arm persisted for 4 weeks.				Y					U	11/10/2000	11/13/2000	3	MRI on 11/25/00	OTH	PVT		NONE	Type II diabetic- controlled, Allergic to sulfa and penicillin.	~Influenza (Seasonal) (no brand name)~1~69.00~In Patient		1						1	Injection site reaction; Vertigo	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0164328	01/02/2001	VA	71.0	71		F	12/11/2000	Approximately 3 hours after injection the patients arm turned red, started swelling, and itching occured approximately 2 days. It was very red from the site of injection to her wrists.									Y	12/04/2000	12/04/2000	0		UNK	UNK						1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Pruritus	FLU3~AVENTIS PASTEUR~U0440AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~468136~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0164329	01/02/2001	MI	61.0	61		F	12/22/2000	The patients left shoulder (deltoid) had erythma, warmth, and swelling.				Y					Y	12/20/2000	12/20/2000	0		PVT	PVT		NONE	Penicillin			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~PFIZER\WYETH~4008204~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0164330	01/02/2001	PA	65.0	65		F	12/20/2000	The patient complains of soreness at injection site.  Redness and swelling is also noted. The patient was encouraged to apply a cool pack and alternate with heat. The patient was also encouraged to call MD if symptoms worsen or decreased mobility in limbs. 12/26/00 the patient called and the symptoms subsided, no further problems.									Y	12/18/2000	12/18/2000	0		PUB	PVT	NONE	NONE	Sinus problems			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~AVENTIS PASTEUR~U0439EA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164331	01/02/2001	VA	52.0	52		M	12/28/2000	The patient had a reaction to the flu shot it was fatigue, and fever for approximately 2 days.									Y	12/05/2000	12/05/2000	0		OTH	PUB		NONE	ALLERGIES			1						1	Fatigue; Pyrexia	FLU3~PFIZER\WYETH~4008184~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164332	01/02/2001	TX	52.0	52		F	12/18/2000	The patient has a rash form the vaccine site upto the right side of his neck and over to the anterior right side of her chest, with pain in the same areas: beginning the next day. Suspect that this is herpes zoster recovering.									U	12/11/2000	12/12/2000	1	NONE	PUB	PUB	NONE	crick in left side of neck	Sulfa			1						1	Herpes zoster; Injection site pain; Injection site rash	FLU3~PFIZER\WYETH~4008182~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164336	01/02/2001	NY		50		M	12/23/2000	Dizziness, aches, sweats, chills left arm pain.									Y	12/20/2000	12/20/2000	0		PVT	UNK	Effexor	NONE	No allergies, positive for depression			1						1	Chills; Dizziness; Hyperhidrosis; Pain	FLU3~PFIZER\WYETH~4008198~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164158	01/03/2001	AZ	72.0	72		M	12/28/2000	It was reported that a 72 year old male pt received a Fluzone SV '00-'01 vaccination on 12/13/00 at 13:30. Reportedly, the pt died within 48 hours, post vax, of myocardial infarction. Further information has been requested.  15-day follow-up received on 1/31/01 provided no additional data. This case is closed.	Y	12/15/2000							N	12/13/2000	12/15/2000	2	NONE	PVT	PVT	Zaroxolyn, vasotec, levoxyl, bunetanide, lipitor, k-dur, vanceril, azmacort, atrovent, nitrostat	NONE	CAD; Chronic CHF		U2000009900	1						2	Myocardial infarction	FLU3~AVENTIS PASTEUR~U6453AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0164353	01/03/2001	OH	56.0	56		M	11/08/2000	Works at grain elevator across from Health Dept. Employer noticed that he was confused and called his wife who works at the Health Dept, to come get him. She brought him in to have BP checked. His color was slightly flushed. BP was 100/?, then became very pale diaphoretic with no complaints of pain. Lowered to the floor, feet elevated on scene. O2 administered per nurse. Pt's main complaint is that he can't remember anything. Was admitted to hospital on the eve of 11/6/00 and discharged on 11/7/00.				Y	Y				Y	11/06/2000	11/06/2000	0	EKG-neg; Cat Scan-neg; Blood work-all neg; Spinal Tap-neg	PUB	PUB	Cardura, Excedrin for headaches	Tiredness	Hypertension; right inguinal hernia		OH0059	1						1	Confusional state; Flushing; Hyperhidrosis; Hypertension; Memory impairment; Pallor; Respiratory failure	FLU3~AVENTIS PASTEUR~U0406AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0164354	01/03/2001	MO	33.0	33		M	12/22/2000	Around 12/7/00, pt developed numbness then 1 week later, he developed weakness in extremities. Pt stated that he was told he has Guillain-Barre.					Y				Y	11/17/2000	12/07/2000	20	increased protein levels	OTH	PUB	NONE	NONE	NONE		MO2000089	1						1	Guillain-Barre syndrome; Hypoaesthesia; Laboratory test abnormal; Muscular weakness	FLU3~MEDEVA PHARMA, LTD.~E59270GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0164356	01/03/2001	NY	68.0			M	12/22/2000	Report received from a physician via telephone on 12/19/00, regarding a possible adverse event associated with Fluvirin. A 68 year old male pt received Fluvirin on 12/4/00 and that same day, developed redness around the injection site. On 12/7/00, the rash became generalized all over the pt's body. The pt required hospitalization from 12/10/00 through 12/14/00. On the same day that the pt developed the skin rash, the pt also had started Clindamycin 600mg for an unknown reason. No other information was provided and attempts to obtain further information regarding these events, have been initiated.					Y	5			U	12/04/2000	12/04/2000	0	Skin biopsy-showed a skin allergy	OTH	OTH	NONE		NONE		MPI2000049890	1						1	Hypersensitivity; Injection site erythema	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0164361	01/03/2001	CA	22.0			M	12/28/2000	It was reported that a male pt received Fluzone SV '00-'01 vaccination on 12/5/00. Approx. 3 days, post vax, pt developed flu-like symptoms. Pt was admitted to the hospital on 12/10/00. Pt expired on 12/18/00 and an autopsy was done, results not provided. Further information requested. Autopsy also states patient had headaches, muscle aches, diarrha, nausea, vomiting, fever, cough, sore throat, abdominal pain.	Y				Y				N	12/05/2000	12/08/2000	3	Autopsy-pending	UNK	UNK					U200000993	1						1	Abdominal pain; Cough; Diarrhoea; Headache; Influenza like illness; Myalgia; Nausea; Pharyngolaryngeal pain; Pyrexia; Vomiting	FLU3~AVENTIS PASTEUR~U0428AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0164362	01/03/2001	TX	2.0	2	.5	M	12/28/2000	It was reported that a 2 year old male pt received a Fluzone SV '00-'01 vaccination on 11/21/00 and reportedly on 12/1/00, the pt developed left eye tickle, on 12/4/00 he had eye blinking, on 12/6/00, both eyes rolled up to left, on 12/8/00, left side of face twitching and left side of body jerking. On 12/9/00, pt was dx'd with seizure and admitted to the hospital for 1 week. Further information requested. F/U from mailed follow up correspondence rec'd on 7/3/01 it was reported that the pt has not recovered and is still on medication to keep seizures under control. Additional patient and responsible info was also provided. No further info availabel regarding this pt or this case.					Y	7			N	11/21/2000	12/01/2000	10		UNK	UNK					U2000009910	1						1	Convulsion; Dyskinesia; Eye movement disorder; Muscle twitching	FLU3~AVENTIS PASTEUR~U0414BB~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0164390	01/03/2001	OK	39.0	39		F	12/14/2000	Pt developed 3cm X 2cm area of redness and heat with slight swelling in right deltoid.				Y					Y	12/12/2000	12/14/2000	2	NONE	PUB	PUB	NONE	NONE	allergic to mold		OK0051	1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~PFIZER\WYETH~4008181~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0164391	01/03/2001	MA	28.0	28		F	12/26/2000	Pt experienced left arm pain lasting 8 days at the injection site.									Y	12/17/2000	12/18/2000	1		OTH	PVT		NONE	ASA allergy; psoriasis			1						1	Injection site pain	FLU3~PFIZER\WYETH~4008219~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164392	01/03/2001	WI	48.0	48		F	12/07/2000	The pt experienced a rash on the abdomen, spots on left and right thigh above the knee, numbness. Treated with over the counter Benadryl.									U	12/04/2000	12/04/2000	0		PVT	PVT	Demulen; Benzomycin; Flonase		Acne; chronic sinusitis; positive TB skin reaction; allergic to cats, cantaloupe and dyes			1						1	Hypoaesthesia; Rash	FLU3~AVENTIS PASTEUR~UO414BB~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164393	01/03/2001	VA	44.0	44		F	12/19/2000	Pt developed redness, mild fever and pain on left breast. Pt was seen by MD who diagnosed mastitis and treated with Cipro. Redness resolved in one week, pain resolved in two weeks. MD would not rule out or rule on caused by flu shot.				Y					Y	12/08/2000	12/09/2000	1	NONE; mammogram ordered for January	PUB	PVT	Flexil	NONE	Pt allergic to sulfa, cepharadine, Ceftin, Bioxin, Ultram Hydrocodone APAP, Oxycodone APAC; amoxicillin			1						1	Erythema; Mastitis; Pain; Pyrexia	FLU3~PFIZER\WYETH~4008183~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0164394	01/03/2001	MD	26.0	26		F	12/04/2000	Fifteen minutes post vax, pt took aspirin and five minutes later began to see spots. Pt had nausea, dizziness and difficulty breathing. Pt fainted - one minute.  Later felt nauseated. Pt states she had a similar episode a year ago, but it was an anxiety attack. Pt did not seek medical help or evaluation despite recommendation.									Y	11/28/2000	11/28/2000	0	NONE	PUB	PUB	NONE	NONE				1						1	Dizziness; Dyspnoea; Nausea; Syncope; Visual disturbance	FLU3~MEDEVA PHARMA, LTD.~E71300LA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0164395	01/03/2001	MD		75		F	12/08/2000	Pt experienced deep cough, thick mucous, unknown fever, no chills, no aches.  Dry cough 4 days ago - progression, swollen neck, glands, sore throat earlier. Duration 4 days.									U	11/21/2000	12/04/2000	13	NONE	PUB	PUB	Tylenol	NONE				1						1	Cough; Lymphadenopathy; Oedema; Pharyngolaryngeal pain	FLU3~MEDEVA PHARMA, LTD.~E71300LA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0164397	01/03/2001	KS	35.0	35		F	12/26/2000	Pt experienced a sore, scratchy throat, swelling and painful; watery eyes, swelling and red; and shortness of breath. No local reaction noted. Pt was treated with Zyrtec PO X 3 doses.									Y	12/07/2000	12/07/2000	0	NONE	PUB	PVT	NONE	NONE				1						1	Dyspnoea; Eye oedema; Lacrimation increased; Ocular hyperaemia; Pain; Pharyngeal oedema; Pharyngolaryngeal pain	FLU3~AVENTIS PASTEUR~U0454AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164398	01/03/2001	NY	30.0	30		F	12/04/2000	One day post vax pt experienced tenderness in right armpit that resolved within one day. Six days post vax the tenderness returned, the next day right arm very tender, numbness in right arm, thumb and finger tips.									Y	11/13/2000	11/14/2000	1		PUB	UNK	NONE	NONE	NONE			1						1	Hypoaesthesia; Pain	FLU3~PFIZER\WYETH~4008174~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~463727~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0164400	01/03/2001	FL	41.0	41		F	12/20/2000	Pt experienced swollen ears and hives.				Y					Y	12/19/2000	12/19/2000	0	Recommended skin tested.	MIL	UNK	NONE	NONE	environmental allergies			1						1	Ear disorder; Oedema; Urticaria	FLU3~PFIZER\WYETH~4008215~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0164401	01/03/2001	IL	66.0	66		F	12/28/2000	four days post vax pt awakened with great degree of stiffness and pain in arm muscles above and below the elbow and muscles in buttocks. Pt still experiencing same problems at the time of report.				Y					Y	10/25/2000	10/29/2000	4		OTH	OTH		NONE	sulfa			1						1	Musculoskeletal stiffness; Myalgia	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0164402	01/03/2001	CA	64.0	64		M	12/27/2000	Pt experienced three slight dizzy spells about 1.5 hours post vax. Each spell lasted about 20 seconds approximately 30 minutes apart.									Y	12/09/2000	12/09/2000	0		PVT	OTH	Theophyllin, Ventolin, Ranitidine	NONE	Asthma			1						1	Dizziness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0164403	01/03/2001	VI	36.0	36		F	12/20/2000	Pt complained of runny nose, itching and rashes, presented to ER with erythema rashes on the chest, lung clear, no swelling of tongue or neck. Pt treated with Benadryl, Solumedrol, Epinephrine and Tylenol.				Y					Y	12/14/2000	12/14/2000	0	NONE	PUB	PVT	Dilantin, Neosporin MS, Contin	NONE	Intractable headaches, seizures			1						1	Pruritus; Rash; Rhinorrhoea	FLU3~MEDEVA PHARMA, LTD.~E70200KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0164404	01/03/2001	GA	39.0	39		F	12/27/2000	Approximately 1 hour post vax, pt experienced dizziness, numbness spreading from thighs to upper arms, feeling as though she was going to pass out, nausea, loose bowels and shakiness.  All symptoms came in waves, waxing and waning for approximately 7 hours.				Y					Y	11/16/2000	11/16/2000	0	NONE	PVT	PVT	Serevent; Flovent; Singulair; Ventolin; Zithromax	Mild bronchitis	chronic asthma-like lung disease			1						1	Diarrhoea; Dizziness; Hypoaesthesia; Nausea; Syncope; Tremor	FLU3~AVENTIS PASTEUR~U0422CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0904J~1~IM~LA~HEP B (RECOMBIVAX HB)~1	USA	Emergency room visit	Influenza
0164405	01/03/2001	NY	32.0	32		F	12/26/2000	Within a few minutes post vax her arm became swollen, red and hot to touch and very sore.									Y	11/13/2000	11/13/2000	0	NONE	PUB	OTH	Atentol; Paxil	NONE	elevated blood pressure			1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLU3~PFIZER\WYETH~4008174~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~463727~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0164406	01/03/2001	NM	47.0	47		F	12/22/2000	Pts arm was sore and 24 hours later pt experienced fatigue and malaise. Two days post vax RU quadrant pain. the next day pt was seen in ER. Liver enlarged upon physical. Pt treated with Vicodan				Y					U	12/15/2000	12/17/2000	2		PUB	UNK		E Barr, Porphyria, Asthma			AZ0035	1						1	Abdominal pain; Fatigue; Injection site pain; Liver disorder; Malaise	FLU3~PFIZER\WYETH~4008220~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0164407	01/03/2001	NY	61.0	61		F	12/27/2000	Three days post vax pt experienced itching of right wrist, and pinkness of legs, arms and scalp. By the next afternoon pt developed large welts all over and ears were red. Pt went to urgent care and was told it was an allergic reaction to something, possibly flu vax. Pt treated with Benadryl.				Y					Y	12/01/2000	12/04/2000	3		PUB	PUB			diabetes, asthma			1						1	Erythema; Hypersensitivity; Pruritus; Skin discolouration; Urticaria	FLU3~PFIZER\WYETH~4008196~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0164408	01/03/2001	KY	72.0	72		F	12/22/2000	Two days post vax, pt returned to clinic. Complained of left arm hurting, arm red starting at mid upper arm down to below the elbow. Evident swelling right above and below the elbow. Referred to private physician.				Y					U	12/20/2000	12/20/2000	0		PUB	PUB					KY2000046	1						1	Injection site erythema; Injection site oedema; Injection site pain; Oedema	FLU3~PFIZER\WYETH~4008207~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0946K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0164409	01/03/2001	TX	62.0	62		M	12/28/2000	Pt reported running a high fever and rash after receiving vax. Also complained of aching and joint pain. Recovering, fever resolved but achiness remains. Pt still has a rash on arm.										12/26/2000	12/26/2000	0		PUB	PUB	Glyburide, Aetos	NONE	diabetes			1						1	Arthralgia; Pain; Pyrexia; Rash	FLU3~PFIZER\WYETH~4008198~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~469133~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0164410	01/03/2001	MA	25.0	25		F	11/07/2000	Pt complained of soreness in left arm with pain at injection site radiating to clavical and scapular areas. Pt saw nurse at Occupational Health Center at Brigham  Women's and was told it was due to the flu shot and it should subside in 2 days or so.  Pt fully recovered.									Y	11/06/2000	11/06/2000	0		MIL	UNK	BCP	NONE				1						1	Injection site pain; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0164411	01/03/2001	IN	52.0	52		F	12/06/2000	Pt experienced hives on face, arms and knees.									Y	11/30/2000	12/01/2000	1	NONE	PUB	OTH	Ridaura, Thyroid, Procardia	NONE	Rheuarthritis, Raynauds; allergy to OSA and Celebrex		IN200044	1						1	Urticaria	FLU3~PFIZER\WYETH~4008181~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164412	01/03/2001	IN	48.0	48		F	12/06/2000	Pt experienced swelling, redness and itching on left side of face and left arm.									Y	12/04/2000	12/04/2000	0	NONE	PUB	OTH			diabetes, hypertension, hyperlipidemia		IN200043	1						1	Erythema; Oedema; Pruritus	FLU3~PFIZER\WYETH~4008181~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164413	01/03/2001	IN	57.0	57		F	12/27/2000	Pt experienced swelling, redness and streaks going under arm pit from injection site. Injection site was like a boil. Pts entire right shoulder was hot, swollen, and reddened. Body temperature was 101F for approximately two days. Pt also had feelings of fatigue and a cough. Follow up on 01/30/2001: None of this information was given to me.  Was told at open that visiting service should have given me this information.				Y					Y	12/14/2000	12/15/2000	1	NONE	UNK	PVT	Zestril, Prempro, Allegra, Hetz		hypertension, allergic to dust, mold and ragweed.			1						1	Cellulitis; Cough; Fatigue; Furuncle; Injection site erythema; Injection site oedema; Injection site warmth; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0164451	01/04/2001	NY	57.0	57		F	11/07/2002	A nurse reported that her 56 year old aunt received an injection of Flu-Shield (2000-2001 Formula) in 12/00. Two days, post vax, she collapsed and developed nausea, vomiting and dizziness. She was seen in the ER where they reportedly could find nothing wrong and was sent home. Afterwards, she was weak and did not feel well. On 12/25/00, she awoke with right-sided facial paralysis and dropping, was disoriented and did not feel well. She was taken to ER where they reportedly could find nothing wrong and was again sent home. On the way home, she seized in the car and was taken to the hospital where she was admitted into the ICU. The swelling of the brain from the tests, was undeterminable. She was unresponsive until 12/28/00; however, the reporter noted that the pt was very sedated. She developed a fever and was opening her eye briefly and was able to move her legs as of the date of this report.				Y	Y			Y	U	11/18/2000			brain scan - swelling of both sides of the brain, MRI - swelling of both sides of brain, no tumors or infection	OTH	OTH	Baycol, Sudafed	UNK	UNK		HQ5383229DEC2000	1						1	Asthenia; Brain oedema; Coma; Convulsion; Disorientation; Dizziness; Facial palsy; Malaise; Nausea; Syncope; Vomiting	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0164457	01/04/2001	SD	15.0	14		M	11/28/2000	The patient got a vaccination, a golf ball size, red, raised welt appeared. By 8PM hives, large, red welts with the largest welts on the thighs. Joints and hands became swollen (unable to hold pen on Wednesday).  The physician evaluated the patient on Wednesday 11/08/00, prescribed Prednisone, Hydrocortisone cream, soda baths.  Hives lasted approximately 9 days.  Last hives present on bilateral feet.				Y					Y	11/04/2000	11/04/2000	0		PUB	UNK	NONE	NONE	Bactrim			1						1	Injection site nodule; Joint swelling; Oedema peripheral; Rash erythematous; Urticaria	FLU3~AVENTIS PASTEUR~U0405AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0164458	01/04/2001	KS	52.0	52		F	12/26/2000	The patient has achy muscles, burning eyes, headache, and chills. Treatment: Nyquil Employee has multiple allergies: Food testing planned for 1/01.									Y	12/14/2000	12/14/2000	0	NONE	PUB	PVT	Zocor, Zertec	NONE	Environmental allergies			1						1	Chills; Eye pain; Headache; Hypersensitivity; Myalgia	FLU3~AVENTIS PASTEUR~U0434AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164459	01/04/2001	FL	73.0	73		F	12/28/2000	The pt experienced right sided facial droop, diagnosed with bells palsy.				Y					U	12/27/2000	12/28/2000	1	MRI - nml	PVT	PVT	Prevacid, Valium, Levoxyl, Zocor, ASA		hypothyroidism, hypercholesterolemia, GERD, depression			1						1	Facial palsy	FLU3~AVENTIS PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0164460	01/04/2001	ME	52.0	52		F	01/02/2001	The patient had weakness in lower limbs, loss of feeling of balance. The patient has to use a cane to maintain balance. This is new.									N	11/30/2000	12/03/2000	3	Last Flu shot 1976, after had thyroid removed.	PVT	PVT	Synthyroid, Inderal	NONE	Muscular Dystrophy 1980, irregular heart beat.			1						1	Balance disorder; Muscular weakness; Thyroid disorder	FLU3~AVENTIS PASTEUR~U0422DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164461	01/04/2001	NH	47.0	47		F	01/02/2001	The pt complained of vertigo and was unable to drive home. The pt also experienced nausea, vomiting. Vertigo is about 95% improved as of today.									Y	12/12/2000	12/12/2000	0	NONE	OTH	OTH	Premarin	NONE				1						1	Nausea; Vertigo; Vomiting	FLU3~PFIZER\WYETH~4008192~3~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164462	01/04/2001	TN	51.0	53		F	12/05/2000	1 hour post vax, the pt  had severe pain in left arm, and thought she would pass out. The pt also experienced pain at the injection site traveling to the muscles over shoulder blade and down to the wrist, later that night to her hear muscles. The pt experienced a decrease in strength and a decrease in forward range of motion.									U	10/23/2000	10/23/2000	0	NONE	PUB	PVT		NONE	can't tolerate beta blockers		TN00049	1						1	Asthenia; Injection site pain; Joint range of motion decreased; Myalgia; Pain; Syncope	FLU3~MEDEVA PHARMA, LTD.~E67950KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~SMITHKLINE BEECHAM~654A4~2~IM~RA~HEP A (HAVRIX)~1	USA		Influenza
0164471	01/05/2001	DC		43		F	12/06/2000	The pt experienced localized erythema at the site of injection 24 hours post vax. The pt also experienced pain at the injection site,, swelling of tissue with palpable nodule.									U	12/04/2000	12/05/2000	1	NONE	PUB	PUB		NONE	NONE			1						1	Injection site erythema; Injection site pain; Oedema; Skin nodule	FLU3~PFIZER\WYETH~4008180~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164472	01/05/2001	IA	38.0	38		F	12/27/2000	The patient had pain to her left upper arm and shoulder since approximately 2 hrs post administration.  The patient was seen by DR on 12/27/00 and was placed on EC Naprosyn.  The patient was diagnosed with arm soreness.				Y					U	12/13/2000	12/13/2000	0	NONE	OTH	PVT	Tetracycline	NONE	Keflex, and Voltaren allergies.			1						1	Injection site pain	FLU3~AVENTIS PASTEUR~U0447AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0164473	01/05/2001	IA	39.0	39		F	12/27/2000	The pt experienced pain at the shoulder, arm and neck on the same side of injection. The pt went to the MD 9 days post vax and was then diagnosed with muscular pain. The pt was treated for pain and heat.				Y					U	12/13/2000	12/18/2000	5	NONE	OTH	PVT	Celexa, Klonopin	NONE	seasonal allergies			1						1	Feeling hot; Myalgia; Neck pain; Shoulder pain	FLU3~AVENTIS PASTEUR~U0447AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0164474	01/05/2001	IA	53.0	53		F	12/28/2000	The patient has left arm discomfort.									U	12/13/2000	12/13/2000	0		OTH	UNK						1						1	Discomfort	FLU3~AVENTIS PASTEUR~U0447AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164478	01/08/2001	IN				F	01/03/2001	A nurse reported that a pt received an injection of 2000-2001 formula influenza virus vaccine in 2000 and subsequently, developed Guillain-Barre syndrome. This report of a serious, labeled event is being submitted in a 15-day time frame, as requested by FDA. See cancelled report, HQ4993318DEC2000. Follow-up received on 1/2/01, indicated that the pt was an elderly female who received 1999-2000 formula influenza virus vaccine. Five to 6 months, post vax, she developed Guillain-Barre syndrome. She died.	Y								N				UNK	OTH	OTH	UNK	UNK	UNK		HQ5472103JAN2001	1						1	Guillain-Barre syndrome	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0164495	01/08/2001	MS	76.0	76		F	12/21/2000	The patient received the Influenza vaccine on 12/12/00. The patient stated it was very painful when given. The patient returned on 12/20/00 and stated his arm had been painful and achy since injection was given. No edema or erythema was noted a the site, the patient stated it hurts badly to move her arm. Upon inspection the arm appeared normal, but the patient stated she had trouble using the arm but could do ROM, no numbness noted.									N	12/12/2000	12/12/2000	0	NONE	PUB	PUB		Arthritis	Arthritis		MS00055	1						1	Injection site pain; Pain	FLU3~PFIZER\WYETH~4008198~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164496	01/08/2001	NJ	52.0	52		M	11/22/2000	The patient has pain in her left arm which developed about one week following the Flu shot. The patient did not receive vaccine last year, but previously vaccinated.									U	11/03/2000			NONE	PUB	PUB	Thyroid replacement, Provacal	NONE	NONE		NJ200025	1						1	Injection site pain	FLU3~AVENTIS PASTEUR~U0409AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164497	01/08/2001	NY	58.0	58		F	11/29/2000	The patient has epigastric pain, nausea, shakiness, chills, and weakness for about 6 hours (started 18 hours approximately after injection). The patient had some lower abdominal cramping, and slight diarrhea the second day after her shot.									Y	10/30/2000	10/31/2000	1	NONE	OTH	UNK	Singular, Zyrtec, Vitamins, Minerals, and Herbs	NONE				1						1	Abdominal pain upper; Asthenia; Diarrhoea; Nausea; Tremor	FLU3~AVENTIS PASTEUR~U0408CA~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164504	01/09/2001	LA	4.0	4		M	12/26/2000	Admitted to hospital on 12/6/00 with cellulitis to left arm which was red and swollen with tenderness.					Y	2			Y	12/04/2000	12/05/2000	1		PVT	UNK		URI			LA001202	1						1	Cellulitis; Injection site erythema; Injection site pain; Injection site swelling	FLU3~AVENTIS PASTEUR~U0421AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0164505	01/09/2001	KY	74.0	74		M	01/04/2001	Guillain-Barre Syndrome and later developed acute renal failure; started as pain in feet and legs. Admitted to the hospital on 12/26/00. Received IVIG  and IV contrast which may be related to acute renal failure. Per F/U 5/1/01: BP 220/100. During her stay in the hospital, she gradually became weak and worse. Attempts to insert an IV line were made, but it was unsuccessful anf for this reason, we had asked MD to see her to insert a Port-A-Cath which was performed on 12/27/00. The pt was then given 8mg of Globulin, immunogloblin, 17 grams daily for 5 days over 16 hours. However, this was discontinued on 12/30/00 after 4 dosages, after she developed an elevated BUN and creatininie who had a history of was felt to be secondary to the immunoglobulin. Because of this, we had asked MD to see her who then started her on short-term dialysis. Slowly and gradually the rhythm failure improved. She remained stable and was then transferred to the skilled nursing facility on 1/16/01. Impression: Guillain-Barre syndrome, improving; Acute renal failure, transient secondary to the immunoglobulin therapy; hypertension.			Y		Y			Y	Y	12/09/2000	12/16/2000	7	MRI cervical spine-shows mild accentuation of cervical lordotic curve; MRI of thoric spine as well as the lumbosacral spine were nml; Cat Scan of brain-showed a small focus of low denisity signal in the posterior limb of the right internal coccal, consistent with an old lunar infarction; CT scan chest-showed 1cm in the terminate area of ill-defined density or infiltrate in the right upper lobe and another 3 to 4mm circumscribed nodule in the lingular segment of the left upper lobe; attempts to do the LP on 12/26/00 were unsuccesssful. With fluorscopic guidance, an LP was performed by the radiologist-slight elevation of the spinal fluid protein which was 4 to 7, spinal fluid chloride was 115, which were wnl; Gram stain, as well as, a smear for fungus-wnl.	PUB	UNK	Cozaar, Lopid, Procardia XL, Lasix, potassium ibuprofen	NONE	Hypertension	Arm swelling~Pneumo (no brand name)~1~74.00~In Patient		1						1	Asthenia; Blood creatinine increased; Blood urea increased; Bone disorder; CSF test abnormal; Guillain-Barre syndrome; Hypertension; Lung disorder; Nuclear magnetic resonance imaging brain abnormal; Pain; Renal failure acute	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0164506	01/09/2001	CA	77.0	77		M	12/27/2000	The morning after the injection, the pt complained of fever 100F, aches, chills and felt stiff. The next day, he had fever, was pale and weak, so went to the doctor. He was hydrated with a pint of fluids and given Tylenol. Pulse was rapid. Had a low-grade fever for the rest of the week. On 12/18/00, went to the doctor. Pulse 190, low BP. Was sent to the hospital and put in ICU for 2 days, then sent home on Coumadin, Digoxin and Cardizem. (Did not have difficulty breathing). He is feeling better and has an appointment in 2 months. 60 day follow up states patient has shortness of breath and gets tired more easily. Per review of Hospital D/C Summary add diagnosis of 2:1 AV Block./awb				Y	Y	2			U	12/11/2000	12/12/2000	1	blood tests, chest x-ray, echocardiogram, electrocardiogram	PUB	PUB	Lotensin	NONE	Hypertension. Add hyperlipidemia, BPH, heart murmur, rosacea per review of Hospital D/C Summary./awb		CA000155	1						1	Asthenia; Blood pressure decreased; Dehydration; Dyspnoea; Fatigue; Heart rate increased; Musculoskeletal stiffness; Pain; Pallor; Pyrexia	FLU3~AVENTIS PASTEUR~U0409AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0164514	01/09/2001	WY	57.0			F	12/29/2000	The patient had a hard, tender, knot appear at the injection site that has moved to the back of the deltoid area.  It is now less tender and some what smaller after the patient took several doses of Benadryl over the past 4 days and Hydrocortisone cream.  Zero redness was noted.									U		12/08/2000		NONE	PUB	PVT		NONE	NONE			1						1	Injection site induration; Injection site nodule; Tenderness	FLU3~PFIZER\WYETH~4008202~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164515	01/09/2001	CA	66.0	66		M	12/21/2000	The patient states that approximately 24 hours after receiving the Flu vaccine he began having abdominal cramping. The cramping became severe  so he went to his PDM. He was diagnosed with viral gastritis.  He is now on bedrest, clear fluids and meds for relief of symptoms, and he continues to have a low grade temperature. He has a follow up appointment on 12/21/00.				Y					U	12/15/2000	12/16/2000	1	NONE	PUB	PUB	Norvasc, Benadryl	none	Laryngectomy due to cancer, hypertension, elevated cholesterol, allergic reaction		CA000154	1						1	Abdominal pain; Gastritis; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~e73110la~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0164516	01/09/2001	WI	46.0	46		F	01/03/2001	The patient received a vaccine and seven days after receiving it the patient began sneezing and developed a hive on her wrist.  By midnight she had hives all over her whole body so she took Benadryl. The patient then developed more hives, so she went to see her doctor; where she was treated this was 25 hours after she received her vaccine. The patient went to the ER 35 hours after receiving the vaccine to be treated because the hives continued to develop. The patient was treated with Benadryl, Solu-Medrol, Zantac, Epinephrine, Albuterol nebulized inhalation, Prednisone, Ranitidine, and Zyrtec.				Y					Y	12/04/2000	12/04/2000	0		OTH	PVT			Allergies- Penicillin, Bactrim, Asprin.			1						1	Sneezing; Urticaria	FLU3~AVENTIS PASTEUR~U0447AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0164517	01/09/2001	MD	50.0	50		M	12/06/2000	The patient developed a cough, redness, swelling and soreness at the site of the injection on 11/17/00 in the PM. The patient was seen by his family physician who prescribed cough medicine with codeine. The patient states the cough was somewhat alleviated but still complains of soreness and achiness in left arm to date.  He has trouble lifting and or reaching. Pain in the shoulder still 12/29/00.									N	11/16/2000	11/17/2000	1	NONE	PUB	PUB	Hypertensive med	NONE	Diabetic Type II		MD00013	1						1	Cough; Injection site erythema; Injection site reaction; Injection site swelling	FLU3~AVENTIS PASTEUR~U0346AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164518	01/09/2001	MD	72.0	72		M	12/07/2000	The patient had soreness in his arm that soon after developed into pain in the upper arm especially when raising his arm.  A small knot still present at the site. No systemic symptoms. Plans to see PMD if no improvement.									N	11/02/2000	11/05/2000	3	NONE	PUB	PUB	NONE	NONE	NONE		MD00014	1						1	Injection site nodule; Injection site pain	FLU3~AVENTIS PASTEUR~U0346AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164519	01/09/2001	MN	23.0	23		F	12/07/2000	The patient had a fever of 102.4, swollen (the size of an orange), hard, hot, painful injection site. The patient also had achiness and feeling wiped out. On 12/7/00 the fever was 99.6 this morning feeling better. On 12/11/00 the patient recovered.				Y					Y	12/05/2000	12/06/2000	1		PUB	PUB	Insulin, Levo-Tabs, BCP	NONE	Allergic to Sulfa & Mins, Diabetes (when 13 yrs old), Sarcoid Cancer of bone (in remission).		MN0008	1						1	Fatigue; Injection site induration; Injection site oedema; Injection site pain; Injection site warmth; Pain; Pyrexia	FLU3~PFIZER\WYETH~40008183~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0945K~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0164520	01/09/2001	NY	71.0	71		F	01/02/2001	The patient had severe pain in the right arm about three hours after an injection. On 12/22/00 the patient fainted in the store. Arlington EMS was called they checked the patient out and then the patient went home, and notified her doctor that the pain continued.  By 10 PM on 12/22/00 the patient arm from elbow almost to the shoulder, was so swollen, difficult to get shirt off. Arm also had become very warm and purple color. Swelling worse the next day. Swelling and soreness finally over on 12/27/000.									Y	12/21/2000	12/22/2000	1		PUB	OTH						1						1	Contusion; Injection site pain; Injection site warmth; Oedema; Syncope	FLU3~PFIZER\WYETH~4008206~7+~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~463748~2~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0164521	01/09/2001	CO	10.0	10		F	12/28/2000	The patient had an allergic reaction at the injection site within 48 hrs.									Y	12/19/2000	12/20/2000	1	CBC-wnl	UNK	UNK	NONE	NONE	NONE			1						1	Injection site reaction	FLU3~AVENTIS PASTEUR~60444AB~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164522	01/09/2001	NY	79.0	79		F	12/29/2000	The patient had diarrhea, vomiting, severe chills, headache and whole body aching all afternoon and all night on 12/07/00. The next day all of the symptoms were gone.									Y	12/07/2000	12/07/2000	0		OTH	OTH	Trimterene, 2 baby Aspeqin					1						1	Chills; Diarrhoea; Headache; Pain; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0164523	01/09/2001	OH	8.0	8		F	12/25/2000	The patient developed a rash from her shoulder on up, following vaccination on 12/18/00. The patient saw her PCP 12/19/00, she was treated with Benadryl.  The rash increased to the trunk area through out the day, no trouble breathing, no hospitalization.									Y	12/18/2000	12/19/2000	1		PVT	OTH	Insulin	NONE	Type I Diabetes Mellitus			1						1	Rash	FLU3~PFIZER\WYETH~4008181~1~IM~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163015	01/10/2001	OH	67.0			F	11/27/2000	clinical diagnosis - Gullian Barre of lower extremities. The follow-up states that a dignosis of Wegener's granulometosis was made.							Y		Y				EMG pending	PVT	PVT	Mysoline, Klonapin	NONE	diverticulosis, borderline BS, benign tumor, spastic ?????			1						2	Guillain-Barre syndrome; Wegener's granulomatosis	FLU3~AVENTIS PASTEUR~0345AL~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0164203	01/10/2001	NM	52.0	52		U		Pt complained of LBP beginning 3 hours, post vax. No fever, rashes, nausea or vomiting or other myalgias. No radiation of pain, no bowel/bladder or other weaknesses.				Y					U	12/18/2000	12/18/2000	0	LS spine films-disc narrowing LS S1	OTH	OTH	NONE	Low back pain	Allergy to PCN		NM120002	1						2	Back pain; Cartilage development disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0164555	01/10/2001	PA	50.0	50		F	12/12/2000	Between 17:00 and 18:00, had red blotch at site (LA) and it was hot/ice applied. At 03:45 had dizziness, palpitations, face and throat were hot, sore and itchy throat and flushed. Went to ER. BP was 180/110; HR 136. About 15 minutes later, had chest pain and was given nitrodrip, Lopressor IV. Had a headache and was given Tylenol and admitted to tele. pressure down. Home x 1 week and returned with experiences same. Achy/sore throat, increased BP and was put on Toprol.				Y	Y	1			Y	11/30/2000	11/30/2000	0	EKG-showed sinus tachycardia; Stress test-nml per employee	PVT	OTH	E-Vista	NONE	menopause, arthritis	Local reactions x 2~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Chest pain; Dizziness; Feeling hot; Headache; Heart rate increased; Hypertension; Injection site erythema; Injection site warmth; Palpitations; Pharyngolaryngeal pain; Rash macular; Sinus tachycardia	FLU3~AVENTIS PASTEUR~U0440AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0164557	01/10/2001	WI	80.0	79		F	11/22/2000	Pt called the assistant director and informed her that she was hospitalized after receiving vaccines for congestive heart failure.				Y	Y	3			Y	11/09/2000	11/09/2000	0	NONE	OTH	PUB	K-Dur, aspirin, atenolol, Vasotec, furosemide, ranitidine, Glucotrol XL, allopurinol	NONE	congestive heart failure, diabetes, hypertension, arthritis, constipation, arrhythmia, angina			1						1	Cardiac failure congestive; Cardiac failure congestive; Condition aggravated	FLU3~PFIZER\WYETH~4008174~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~463717~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~U0266BA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4008174~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~463717~UNK~IM~LA~PNEUMO (PNU-IMUNE)~2|TD~CONNAUGHT LABORATORIES~U0266BA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0164558	01/10/2001	NY	63.0	63		M	11/20/2000	Right deltoid muscle red and inflammed. Pt went to local ER and was admitted with cellulitis of right arm.				Y	Y	1			Y	11/17/2000	11/19/2000	2	cellulitis	PUB	PUB	UNK	NONE	UNK			1						1	Cellulitis; Injection site erythema; Injection site inflammation	FLU3~AVENTIS PASTEUR~U0416FA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~465912~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0164563	01/10/2001	AK	74.0	74		F	11/15/2000	Hospitalized 11/3/00 for 12 days. Discharged on 11/15/00 and re-admitted on 11/19/00 with the flu. Returned home on 11/28/00. Admitted on 11/3/00 with severe respiratory distress.  Diagnosed with exacerbation of COPD, Anxiety, Depression, Chest Pain				Y	Y	12			Y	11/02/2000	11/03/2000	1		UNK	UNK	Lasix, Potassium,Lanoxin, Quinine Sulfate, Nitrglycerin, Alrovent, Albuterol, Severant, Flovent	NONE	Angina, COPD		AK200104	1						1	Anxiety; Chest pain; Condition aggravated; Depression; Influenza; Respiratory distress	FLU3~PFIZER\WYETH~4008171~5~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0164574	01/10/2001	CA	79.0	79		F	11/20/2000	Pt experienced bruising, redness, swelling and painful are at injection site.  Pt complained of burning and stinging after injection. Pt was referred to doctor.				Y					U	11/15/2000	11/15/2000	0		OTH	OTH	diabetes meds	NONE	DM, HTN			1						1	Injection site erythema; Injection site haemorrhage; Injection site oedema; Injection site pain; Pain; Skin burning sensation	FLU3~MEDEVA PHARMA, LTD.~E64330HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0164575	01/10/2001	MA	63.0	63		F	11/09/2000	Pts right arm became red and swollen.  Swelling extended to wrist, elbow and under arm. Pts arm doubled in size. Pt was seen by covering physician and then primary doctor on 11/06.				Y					Y	11/03/2000	11/03/2000	0		PUB	PUB		NONE				1						1	Injection site erythema; Injection site oedema	FLU3~AVENTIS PASTEUR~U0346AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0710K~1~SC~RA~PNEUMO (PNEUMOVAX)~1|TTOX~MASS. PUB HLTH BIOL LAB~TD70~1~IM~RA~TETANUS TOXOID, ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0164576	01/10/2001	AR				U		Pt reported that he was not feeling well over the weekend following vax. Pt began feeling very ill, with fever, chills, body aches, severe headache on Tuesday evening while at work. Pt was unable to work on Wednesday due to fever up to 102.4, chills, severe arthralgia, severe myalgia, headache, weakness, joints were hot, and dizziness. This lasted the entire day. Pt returned to work on Thursday, feeling better, but still with milder symptoms. Pt has had the flu vax the past 3 years without incident.									Y	10/27/2000	10/28/2000	1		PVT	OTH		NONE			AR0052	1						1	Arthralgia; Asthenia; Dizziness; Feeling hot; Headache; Malaise; Myalgia; Pain; Pyrexia	FLU3~AVENTIS PASTEUR~U0403AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164577	01/10/2001	NC	37.0	37		F	11/30/2000	Approximately 8 hours post vax pt began to experience itching all over and turned red. Pt took Benadryl and went to bed. The following two days the symptoms of itching and redness continued with no rash.									Y	11/21/2000	11/21/2000	0		OTH	PVT	Claritin, Prilosec, iron supplement	NONE	anemia, reflux, seasonal allergies			1						1	Erythema; Pruritus	FLU3~PFIZER\WYETH~4008171~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164578	01/10/2001	PA	71.0	71		F	12/13/2000	Pt claims extreme weakness about 3 days post vax. Pt has H/O fibromyalgia with extreme weakness and has severe depression. Physician has documented phone calls in the chart from 2 weeks prior to vax where pt complained of increased fatigue and weakness and pt had stopped several of her prescriptions prior to this incident.									N	10/12/2000	10/15/2000	3	NONE	PVT	PVT	Verapamel, ????, Nervasc, Bumex, Atenolol, Premarin	fibromyalgia, HTN	CAD, depression, fibromyalgia, DTD, chronic fatigue			1						1	Asthenia; Depression; Fatigue; Fibromyalgia	FLU3~AVENTIS PASTEUR~U0337AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164579	01/10/2001	TX	87.0	87		M	12/21/2000	One day post vax the pt developed macropapular scattered areas, scattered around right deltoid area from .5 to 1.5 cm. Diagnosis: allergic reaction. Pt was treated with Allegra									U	12/20/2000	12/20/2000	0		PVT	PVT	IsosorbMono, Toprol, Nitro Quick	increased PSA, knee pain	cholelithiosis, NN anemia, Hx Cardiac Arrythmia			1						1	Hypersensitivity; Rash maculo-papular	FLU3~AVENTIS PASTEUR~U0449AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~474937~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0164580	01/10/2001	OH	78.0	78		F		Pt complained of confusion, disorientation and aura-like symptoms following flu shot. Felt sick to stomach evening of vax. Increased anticonvulsant medication as needed.				Y					U	10/31/2000	11/02/2000	2	EEG scheduled for 11/30/2000	PUB	PUB	Dilantin, Thyroid	NONE	seizure disorder, history of thyroid surgeries			1						1	Confusional state; Disorientation; Stomach discomfort	FLU3~AVENTIS PASTEUR~U0406AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0164581	01/10/2001	IA	50.0	50		F	12/19/2000	One day post vax the pt awoke with inability to control movement in the right arm and leg for about 12 hours in the the arm and about 6 hours in the leg. Vision was also blurred in both eyes for about 12 hours.									Y	12/15/2000	12/16/2000	1	NONE	OTH	PVT	Paxil, Flovent, Prempro, Imitrex, Danocet, Maxair		PCN, Sulfonamide, scallop allergy			1						1	Movement disorder; Vision blurred	FLU3~AVENTIS PASTEUR~U0447AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164583	01/10/2001	CA	26.0	26		F	11/16/2000	Pt became itchy and sweaty. Developed hives and lump in throat. Pt was treated with Benadryl.									Y	11/15/2000	11/15/2000	0		PUB	PVT		NONE				1						1	Hyperhidrosis; Pruritus	FLU3~AVENTIS PASTEUR~U0985011~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164584	01/10/2001	WV	40.0	40		M	12/06/2000	Pt stated that one day post vax he developed generalized rash with intense itching. Pt was treated at local ER with prednisone and Benadryl. Physician stated rash from the flu shot no levoquin. Rash and itching all gone in 24 hours.				Y					Y	11/30/2000	12/01/2000	1	Blood work at ER	OTH	PVT	Levoquin starting 14 days prior to vax	NONE				1						1	Pruritus; Rash; Hypersensitivity; Pruritus; Rash	FLU3~AVENTIS PASTEUR~U0441AA~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~AVENTIS PASTEUR~U0441AA~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0164585	01/10/2001	OH	37.0	37		F	01/05/2001	Pt experienced soreness after vax. Pt complained of red, swollen area 3-4 on arm one day post vax.									Y	01/04/2001	01/05/2001	1	NONE	OTH	PVT	UNK	NONE	allergy to pollen			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~AVENTIS PASTEUR~U0455AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164587	01/10/2001	IL	70.0	70		M	11/09/2000	Pt experienced pain in left arm starting the evening of vax. Pt treated with aspirin. One day post vax, pt woke up still in pain, but minimal unless movement. Area from injection site down to elbow was swollen, red and hot. Pt treated with ice.									U	11/07/2000	11/07/2000	0		UNK	UNK					IL00072	1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~E6433QHA~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1159J~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0164588	01/10/2001	TX	33.0	33		F	12/29/2000	Pt experienced needle, prickly like, itchy sensation all over with headache. Pt also experienced some pressure/uneasiness in throat/breathing.									Y	12/20/2000	12/20/2000	0		PVT	OTH	Allegra, Celebrex	NONE	allergic to nickel, mercury compound			1						1	Dyspnoea; Headache; Paraesthesia; Pharyngeal oedema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0164589	01/10/2001	NM	77.0	77		F	11/16/2000	Pt began generalized itching of entire body the evening of vax. Pt developed rash, red, raised welts over most of body on day post vax; worse around neck and upper back. Three days post vax skin is flaking off and itching continues.									Y	11/13/2000	11/14/2000	1		PUB	PUB	Allegra, Indural, Adican, Loratab	diverticulosis-ostomy (08/21/2000); IBS; hypertension	PCN, Sulfa, Cipro, Flagyl		NM110003	1						1	Erythema; Pruritus; Rash; Skin exfoliation; Urticaria	FLU3~PFIZER\WYETH~4008173~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164590	01/10/2001	GA	11.0	11		F	12/08/2000	Pts mother states after injection pts left arm became warm, slightly swollen, and itchy. Was seen by physician due to warmth and swelling. No treatment ordered.									Y	11/14/2000	12/08/2000	24	NONE	PUB	PUB	Vanceril	NONE			GA00145	1						1	Injection site hypersensitivity; Injection site oedema; Injection site warmth; Pruritus	FLU3~AVENTIS PASTEUR~U042CCA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164591	01/10/2001	GA	69.0	69		F	12/01/2000	One day post vax pt woke up with a swollen, red and sore arm. Pt applied ice and took Tylenol. Left arm still red and sore to touch., Advised to apply warm compresses and Tylenol.									U	11/27/2000	11/28/2000	1	NONE	PUB	PUB	Tamocifin	NONE	Cancer of right breast; bee stings and green pepper allergies		GA00140	1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~AVENTIS PASTEUR~U0422DA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164592	01/10/2001	IL	46.0	46		F	12/21/2000	Pt experienced headache the evening of injection. Pt observed arm which was red, raised and tender at injection site. Pt was seen by physician one day post vax. Area at injection sit 1.5 - 2 circumference 3. Pt treated with Trimamcinolone cream.				Y					Y	12/19/2000	12/20/2000	1	NONE	PUB	PVT	BP med - Teveten and Zoloft	NONE				1						1	Headache; Injection site erythema; Injection site pain; Injection site swelling	FLU3~PFIZER\WYETH~4008219~4~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0164654	01/11/2001	FL	65.0	65		F	12/18/2000	The pt experienced extreme weakness to the point of nearly passing out, nausea and dizziness. Diagnosed with visual disturbance and increased blood sugar					Y	3			N	11/15/2000	11/17/2000	2		OTH	PUB	Coumadin, aspirin	NONE	L. occipital Lobe infarct,Meniere's DX, HTN, Mitral Valve Prolapse, Arthritis			1						1	Asthenia; Dizziness; Hyperglycaemia; Nausea; Visual disturbance	FLU3~AVENTIS PASTEUR~U00421AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0164655	01/11/2001	NY	38.0	38		F	01/09/2001	A physician reported that a 36 year old female received an injection of Flu Shield '00-'01 formula in December, 2000. Approx. 8 days, post vax, the pt developed cranial nerve neuropathy. She was hospitalized. Follow-up information received from the physician on 2/20/01, indicated that this 38 year old female underwent a lumbar puncture. Results showed an increased protein level, normal glucose and 250 white blood cells. A subsequent LP showed a decrease in protein level. Unspecified testing was negative for toxoplasmosis, meningitis, tuberculosis, cytomegalovirus, Lyme disease, herpex simplex virus, Epstein-Barre virus, cryptococcosis and diabetes. A CD4/CD8 ratio was low. The physician reported that the pt is being treated for HIV. Follow-up information received on 4/23/01 via telephone message from the reporting physician, indicated that the pt is not out of contact. Results of other tests indicate that the cause of her 3rd nerve palsy is not related to the flu vaccine.					Y	14			U	12/01/2000	12/09/2000	8	LP X 2-abn; Unspecified testing-neg; CD4/CD8 ration-low; HIV-pending	OTH	OTH	UNK	UNK	UNK		HQ5588305JAN2001	1						1	CSF test abnormal; HIV infection; Laboratory test abnormal; Neuropathy; Paralysis	FLU3~PFIZER\WYETH~4008193~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0164658	01/11/2001	PA	75.0	75		M	01/03/2001	Guillain-Barre Syndrome, weakness in legs, fall at home. Per F/U 3/23/01: The final dx was Gullain-Barre Syndrome which was made by a Neurologist. Within 4 weeks prior to the dx, the pt had cold symptoms. Per F/U 4/3/01: Pt is able to get up with moderate assistance. Gait is quite ataxic. In therapy, the pt made excellent progress. By the time of discharge, he was ambulating several hundred feet independently with a walker. Medications at discharge: Flomax 0.4mg po daily; multi-vitamins 1 po daily; Furosemide 20mg po daily; Coumadin 2mg po daily; Lanoxin 0.25mg po daily, Clorazepate 3/75mg po tid prn. The pt had received a routine flu injection and seemed to have no difficulty. About a week later, he developed upper respiratory tract infection symptoms. One or 2 weeks later, he developed some difficulty walking and weakness in the legs and ataxia and sensory dysfunction.					Y	10	Y		Y	12/01/2000	12/09/2000	8	Spinal Tap; CT of head; Per F/U 4/3/01: Coumadin therapy and INR's were therapeutic at 2.52 and 2.80, hemoglobin-14.2; hematocrit-42.4.	PVT	PVT			allergy to PCN; hx of CHF, Atrial Fibrilation, BPH, mitral valve replacement 5/98; Per F/U 4/3/01: Positive history of anxiety and prostatism; pilonida cyst removed; tonsillectomy and milignant melanoma removed from face and neck without recurrence. He also has an allergy to aspirin.			1						1	Coordination abnormal; Fall; Guillain-Barre syndrome; Influenza like illness; Muscular weakness; Sensory disturbance	FLU3~MEDEVA PHARMA, LTD.~E74060MA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0164662	01/11/2001	MD				F	01/04/2001	Pain at site, then rest of arm. Seen by PMP within 48 hours. Presently in treatment with ice, electrical stimulation ROM; under treatment.				Y					U	11/21/2000	11/21/2000	0		OTH	OTH		Crohn's disease	Crohn's disease			1						1	Injection site pain; Pain	FLU3~AVENTIS PASTEUR~UG408CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0164663	01/11/2001	CA	40.0	40		F	12/27/2000	Sick flu-like symptoms X 10 days (began on skin with fine rash off and on with hot, itchy skin X 10 day and some nausea and vomiting). History of having just started a new Estrogen replacement on 12/1/00. Referred to PMD for evaluation with regards to new HRT.									U	12/14/2000	12/24/2000	10	NONE	PUB	PVT	Hormone replacement therapy	NONE	Premature menopause with HRT since 1995.			1						1	Feeling hot; Influenza like illness; Nausea; Pruritus; Rash; Vomiting	FLU3~PFIZER\WYETH~4008202~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164664	01/11/2001	PA	79.0	79		F	01/04/2001	I became very weak and had difficulty breathing. The feeling lasted for several hours. Later in the evening, I had heart palpitations.									Y	11/08/2000	11/08/2000	0		PUB	UNK						1						1	Asthenia; Dyspnoea; Palpitations	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0164665	01/11/2001	OH				F	01/04/2001	10 days, post vax of flu vaccine, employee had enlarged lymph nodes in armpit (L) and left side of neck swollen. Swelling did not subside until 11/22/00.									Y	11/07/2000	11/17/2000	10		UNK	UNK	Levoxyl; Claritin-D		History of hypothyroidism			1						1	Lymphadenopathy	FLU3~AVENTIS PASTEUR~U0346AA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164692	01/12/2001	NY	52.0	52		F		On 11/14/00, this 52 year old female received a Fluvirin vaccination at her local drugstore. A few days later, she developed bilateral soreness/weakness of her shoulders. She also noted a rash on her right hand and on bony prominences; knuckles, ankles and elbows. The dx of dermatomyositis has been made. Pt states that dermatomyositis is sometimes involved with cancer, but that her tests have all been negative for malignancy. Additional information has been requested. The follow up received on 3/22/01 states dermatomyositis, muscle weakness, muscle soreness, and rash (November 2000).									U	11/14/2000			Blood tests revealed elevated CPK and aldolase. A muscle biopsy was positive for myositis.	OTH	PVT	NONE		NONE		MPI2001000080	1						1	Aspartate aminotransferase increased; Blood creatine phosphokinase increased; Dermatomyositis; Muscular weakness; Myalgia; Pain; Rash	FLU3~MEDEVA PHARMA, LTD.~H68800KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0164696	01/12/2001	CA	73.0	73		M	12/27/2000	The nurse who gave me the shots in the line I was in, gave me 2 shots and when I asked her why she gave me 2 shots, she mumble something that I could not understand. By 20:00, that same day, my body was covered with hives from my neck to my feet. My genitals, legs, ankles and feet were all very swollen. There was no itching, but I felt unwell and uncomfortable and very frightened, to say the least. I have been getting the flu shots every year for the past 10 years and have never had an allergic reaction before. On 11/17/00, I called the clinic and explained what had happened and she said I must have received a pneumonia shoe, as well, however, I did not sign the form for a pneumonia shot, I did not pay the extra $2.00 for a pneumonia shot and I was not in line for the pneumonia shot. My physician prescribed Benadryl, which did not help. My body was so puffed up that I gained 15 pounds in 3 days. I was then prescribed Prednisone, which seemed to help and my body weight gradually returned to normal and the hives are slowly fading. However, as of this date, 4 weeks, post vax, of the 2 flu shots, my ankles and feet are still swollen and I still have red hives on my feet and I still do not feel well. I have gone to several different doctors and none have any definitive answers as to how long this is going to last and what I can do about it. I am getting desperate. Is there someone in your organization who can help me?				Y					U	11/15/2000	11/15/2000	0		OTH	OTH						1						1	Malaise; Swelling; Urticaria; Weight increased	FLU3~MEDEVA PHARMA, LTD.~E64330HA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0164697	01/12/2001	CA	46.0	46		F	01/10/2001	Soreness at site of injection. Nerve pinched. Began to feel sore 7 days, post vax. She called me on 1/8/01 to report not complain, she said. She also felt that the injection was given too high on the arm. (She was an RN) Injection was given in the upper deltoid region and still has intermittent pain.									U	12/04/2000	12/11/2000	7		OTH	PVT		NONE	NONE			1						1	Injection site pain; Nerve compression	FLU3~MEDEVA PHARMA, LTD.~E71300LA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0164698	01/12/2001	OK	49.0	49		F	01/04/2001	Petechia appeared from knees down (bilateral) and persist to date, starting the day after vaccination.									U	12/01/2000	12/02/2000	1		PVT	PVT	Levoxyl, Prempro	NONE	Hypothyroidism; replaced			1						1	Petechiae	FLU3~AVENTIS PASTEUR~U0447AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164699	01/12/2001	MT	51.0	51		F	11/29/2000	Left arm bruised and became swollen within 1 1/2 of elbow; red, hot and sore. Pt experienced headache and chilling that evening. She visited her physician the next day and he felt it to be an allergic reaction to the flu shot and to never get another one. Treated symptoms with Motrin, fluids and rest.				Y					Y	11/08/2000	11/08/2000	0	NONE	PUB	PUB	Premarin, Synthroid	NONE	Allergy to TD shot, iodine, bees, smoke, animals and grass.	Unspecified reaction~Tetanus Toxoid (no brand name)~~44.00~In Patient	MT0104	1						1	Chills; Contusion; Headache; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~MEDEVA PHARMA, LTD.~E66350AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0164700	01/12/2001	NY	49.0	49		F	01/04/2001	Went to clinic at 17:00 on 12/30/00 with arm swollen and red, 4 below shot site, in left arm. Developed shortness of breath and swollen throat. Treated with 1 shot of Prednisone and po X 6 days and Benadryl X 2 days.				Y					Y	12/29/2000	12/29/2000	0		PUB	PUB	Claritin, Atrovent inhaler	NONE	Airborne allergies, household cleaners and perfumes.			1						1	Dyspnoea; Injection site erythema; Injection site swelling; Pharyngeal oedema	FLU3~PFIZER\WYETH~4008221~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0164701	01/12/2001	MT	87.0	87		M	12/13/2000	3 days, post vax, pt started to have tingling in both hands and feet and felt itchy all over and this lasted almost a week. Now, 1 week later, it feels better but still have a little itching/tingling in hands/feet.									Y	11/17/2000	11/20/2000	3		PUB	PUB	Lanoxin, prednisone, Lasix, Atarax, Accupril, Coumadin, Procardia, Proscar, Imdur, Actos		Atrial fibrillation, COPD, DM Type II, CAD, Arthritis		MT0103	1						1	Paraesthesia; Pruritus	FLU3~PFIZER\WYETH~4008174~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164716	01/16/2001	CA	76.0	76		U		Dizziness, ache, weakness, hands swelling, feels sandy, fingers locking on right hand, runny nose, allergic to flu shot.				Y				Y	U	11/25/2000	11/26/2000	1		MIL	OTH						1						1	Asthenia; Dizziness; Joint stiffness; Oedema peripheral; Pain; Rhinorrhoea	FLU3~MEDEVA PHARMA, LTD.~E71790LA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0164721	01/16/2001	ME	78.0	78		F	01/03/2001	Complaining of shortness of breath; laid back on table and became blue (cyanotic) around mouth and stopped breathing; CPR administered and Epi-pen injected; immediate response. Given epinephrine. Episode lasted approx. 4 minutes, no further incidence.			Y	Y					Y	12/11/2000	12/11/2000	0	NONE	PVT	PUB	Atrovent, Zoloft	NONE	Emphysema		ME01002	1						1	Cyanosis; Dyspnoea; Respiratory disorder	FLU3~MEDEVA PHARMA, LTD.~E64500HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1070K~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening	Influenza
0164733	01/16/2001	MA	45.0	45		M	12/28/2000	On 11/20/2000 it was reported to Employee Health. The patient had a raised rash, tingling in hands. ?Arthritis in the finger. The rash had gone and the patient states the arthritis in his fingers are improving.									Y	11/06/2000	11/08/2000	2		PUB	OTH	NONE	NONE	NONE			1						1	Arthritis; Injection site swelling; Paraesthesia; Rash	FLU3~AVENTIS PASTEUR~VO346AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1661J~UNK~IM~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0164734	01/16/2001	PA	34.0	34		F	01/09/2001	The patient states she had pain and burning at the site of injection, with a lump and redness over the next two weeks. The pain radiated down the wrist and up to the shoulder. The patient was given Naproxen by his PCP.									U	10/10/2000	10/10/2000	0		OTH	OTH			1993 history of left arm musculoskeletal problems			1						1	Injection site erythema; Injection site nodule; Injection site pain; Pain; Skin burning sensation	FLU3~MEDEVA PHARMA, LTD.~E64700HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0164735	01/16/2001	NY				F	11/16/2000	The patient received Aventis Influenza vaccine, and developed Bell's Palsy on the following day. The patient developed left facial droop one day after receiving the Influenza vaccine. She had also received Trastuzumab and Paclitaxel on the same day. An MRI and Lumbar Puncture were performed to rule of Leptomeningitis.				Y					U	11/15/2000	11/16/2000	1	MRI (negative), Lumbar Puncture (negative)	UNK	UNK	Taxol, Herceptin		Metastatic Breast Cancer			1						1	Facial palsy	FLU3~AVENTIS PASTEUR~UO408AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0164736	01/16/2001	MN	73.0			F	12/27/2000	The patient states 1st time was in the middle of the night around 1:30-2:00 AM. There was a rapid heartbeat, dizziness that lasted about 1/2 hour. The 2nd time was while driving, she had a rapid heartbeat, got very hot, and felt like she was going to pass out; that lasted about 15 minutes and started to subside. She does not take flu shots since then.									Y					PUB	UNK	Synthroid, Proventil inhaler, Hydrachlorathyazide	NONE	Asthma			1						1	Dizziness; Feeling hot; Heart rate increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0164737	01/16/2001	UT	74.0	74		M	01/06/2001	The patient states 45 minutes after eating bagel with egg and salsa he became very dizzy, unable to drive his car, and then threw up 4 times. He stayed in bed the rest of the day. He had symptoms of becoming dizzy for several days.									Y	11/30/2000	12/05/2000	5		PUB	OTH		NONE				1						1	Dizziness; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0164739	01/16/2001	MI	18.0	18		F	10/20/2000	The patient had a vaccine, about 6 hours after she began experiencing bruising, arm, elbow and wrist pain, left arm pit and side swelling.									U	10/19/2000	10/19/2000	0		PVT	UNK		NONE	Asthma			1						1	Contusion; Oedema; Pain	FLU3~MEDEVA PHARMA, LTD.~E61770GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0944K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0164740	01/16/2001	MI	48.0	48		F	10/20/2000	The patient had pain and swelling under her right arm, extending along the right side of her ribs. There was redness under her arm and spotty redness on her upper arm, and a bruise at the injection site.									U	10/18/2000	10/20/2000	2		PVT	UNK	Lexxel, Serevent, Prevacio	None	Asthma			1						1	Contusion; Erythema; Oedema peripheral; Pain; Rash macular	FLU3~MEDEVA PHARMA, LTD.~E61770GA~7+~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0944K~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0164755	01/16/2001	NY	51.0	51		F	10/19/2000	Following vaccination, the pt experienced a loss of taste and smell. As of 8/24/00 the symptoms persisted.				Y					N	10/25/1999			UNK	PVT	PVT	vitamins	NONE	UNK		HQ0550201SEP2000	1						1	Ageusia; Anosmia	FLU3~PFIZER\WYETH~4998239~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0164756	01/16/2001	NY	46.0			M		In the fall of 1999, the pt developed a splitting headache and an injection site reaction characterized by swelling, redness, hardness, and warmth. Later he developed malaise which lasted about 1 week followed by mild flu symptoms.									Y				UNK	OTH	OTH	acetylsalicylic acid, lansoprazole	UNK	diabetes mellitus		HQ1146118SEP2000	1						1	Headache; Influenza like illness; Injection site erythema; Injection site induration; Injection site oedema; Injection site warmth; Malaise	FLU3~PFIZER\WYETH~~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164758	01/17/2001	LA	66.0	66		M	12/21/2000	The pt experienced a heart attach and died. The pt had a hx of heart problems in the past.	Y	12/20/2000							N	12/19/2000	12/20/2000	1	UNK	PUB	PUB			History of heart problems in the past.		LA010101	1						1	Myocardial infarction	FLU3~PFIZER\WYETH~4008175~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0164768	01/17/2001	PA	47.0	47		M	01/10/2001	A pharmacy student reported that a 47 year old male received an injection of Flu Shield ('00-'01) on 12/12/00. On 1/7/01, the pt was hospitalized with elevated phenytoin (33 mcg/mL) and phenobarbital levels (no value provided).					Y				U	12/12/2000	01/07/2001	26	Drug level NOS above therapeutic level Phenytoin (Dilantin) and Phenobarbital levels.	OTH	OTH	Dilantin, Phenobarbital	UNK	UNK		HQ5758910JAN2001	1						1	Drug level increased	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0164769	01/17/2001	IN	51.0	51		F	01/09/2001	Pt received flu shot. Next morning area red and sore. Tolerated it for 1 day and then began feeling fluid move about in the shot area. Knot became grapefruit-sized so went to MD and he placed her on Keflex. Arm continued to feel worse and had aches all over body. Temperature was 100F-101F. Was advised by MD to go to ER. Admitted to the hospital for 2 days for IV antibiotics. Could not return to work until 1/4/01.				Y	Y				Y	12/23/2000	12/24/2000	1	X-rays and lab work which showed WBC-elevated; cellulitis	OTH	PUB	UNK	Cellulitis	UNK			1						1	Cellulitis; Injection site erythema; Injection site mass; Injection site pain; Pain; Pyrexia; White blood cell count increased	FLU3~AVENTIS PASTEUR~U0457AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1070K~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0164780	01/17/2001	AR	68.0	78		M	12/07/2000	About midnight the evening of the vax, the pt woke up and went to the bathroom and began to have chills for about 30-40 minutes. The pt felt bad the rest of the night and day, was weak with occasional shorter chills. Did not check temp. Feels ok today 12/7/00.									Y	12/05/2000	12/05/2000	0		PUB	UNK		NONE	NONE		AR0101	1						1	Asthenia; Chills; Malaise	FLU3~AVENTIS PASTEUR~U0447AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164781	01/17/2001	UT	73.0	73		F	01/04/2001	The pt experienced adverse reactions from the flu vaccine at the injection site which included redness, swelling (grapefruit size in diameter), rash, itching, symptoms began to resolve by 1/2/01 when she called the pharmacy.									Y	12/29/2000	12/30/2000	1	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site rash; Pruritus	FLU3~PFIZER\WYETH~4008195~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164782	01/17/2001	MI	38.0	38		F	01/08/2001	One day post vax, the pt developed a rash on upper anterior and posterior chest. Treated with over the counter medications and then resolved.				Y					Y	12/06/2000	12/07/2000	1	NONE	PUB	PVT		NONE	allergy to PCN, sulfa, Flagyl, Benadryl, Atarax, Thimerosal			1						1	Rash	FLU3~AVENTIS PASTEUR~U0399EA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0164783	01/17/2001	TN	57.0	57		F	12/20/2000	The pt experienced a localized red and warm area at the injection site. This subsided in about 3 days after it appeared. No other symptoms were experienced.									Y	11/14/2000	11/15/2000	1		OTH	PVT						1						1	Injection site erythema; Injection site warmth	FLU3~PFIZER\WYETH~4008178~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164784	01/17/2001	VA	40.0	40		F	12/15/2000	The pt experienced numbness in the right arm immediately following the vax. The pt also experienced discoloration of the arm and swelling of the right hand, and flushed face. By 10:30 am, the face became pale and a red rash appeared. BP 163/103 and a rapid pulse of 103-105. Diagnosis of anaphylactic reaction treated with Benadryl.				Y					Y	12/15/2000	12/15/2000	0		PUB	PUB		NONE	hypothyroid, allergy to sulfa	numbness in left arm~Influenza (Seasonal) (no brand name)~~39.00~In Patient		1						1	Anaphylactic reaction; Erythema; Heart rate increased; Hypertension; Hypoaesthesia; Oedema peripheral; Pallor; Rash; Skin discolouration; Anaphylactic reaction; Flushing; Heart rate increased; Hypertension; Hypoaesthesia; Injection site reaction; Oedema peripheral; Rash; Skin discolouration	FLU3~PFIZER\WYETH~4008180~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4008180~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0164785	01/17/2001	ID	39.0	39		F	11/22/2000	The pt experienced neurological symptoms which included numbness and tingling in legs and hands. The pt was diagnosed with Type I multiple sclerosis on 4/30/00. Was in remission at the time of vaccination.				Y					Y	11/06/2000	11/09/2000	3	NONE	PVT	PVT	Avonex, glucosamine		multiple sclerosis - in remission		ID00054	1						1	Hypoaesthesia	FLU3~AVENTIS PASTEUR~U0403AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0164786	01/17/2001	CA				F	01/10/2001	The pt experienced red arm inflammation which was red and sore. The arm was difficult to mobilize and was painful. The area was from the deltoid to the elbow. It was hot to the touch. The pt was treated with Tylenol and Benadryl.									N	12/13/2000				OTH	PVT						1						1	Injection site erythema; Injection site inflammation; Injection site pain; Injection site warmth	FLU3~MEDEVA PHARMA, LTD.~E71300LA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0946K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0164787	01/17/2001	MA	17.0	17		F		The pt developed localized redness, warmth, swelling and itching. The pt also experienced fever of 99.6 and dizziness.									U	01/09/2001	01/10/2001	1		OTH	PUB	NONE	NONE	NONE			1						1	Dizziness; Injection site erythema; Injection site oedema; Injection site warmth; Pruritus; Pyrexia	FLU3~AVENTIS PASTEUR~U0346AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164788	01/17/2001	MA	17.0	16		F		On 1/10/01, the pt developed localized redness, warmth, swelling, itchiness, fever of 99.6 and dizziness.									U	01/09/2001	01/10/2001	1		OTH	PUB	NONE	NONE	NONE			1						1	Dizziness; Injection site erythema; Injection site oedema; Injection site warmth; Pruritus; Pyrexia	FLU3~AVENTIS PASTEUR~U0346AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164789	01/17/2001	SC	36.0	35		F	12/14/2000	On 12/2/00 the pt complained of left arm weakness, pain in left upper arm, numbness in fingers on left hand and an aching in left arm. Constant ache continued until 12/6/00. She tool OTC Advil for pain relief on 12/2/00 and 12/3/00. She reported these symptoms to her MD.									Y	11/30/2000	12/02/2000	2		PUB	PUB	NONE	NONE	NONE		SC00091	1						1	Hemiparesis; Hypoaesthesia; Pain	FLU3~MEDEVA PHARMA, LTD.~E66350HA~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0164790	01/17/2001	CA	34.0	34		M	12/18/2000	The pt complained of discomfort to the arm pit, inner aspect, LUE when raising arm up. The pt had palpable lymph nodes X 3 in left arm pit. No neuro deficit. Neurological checks equal bilateral adequate ROM.									U	10/25/2000	10/27/2000	2		PVT	UNK	NONE	NONE	NONE			1						1	Lymph node pain; Lymphadenopathy	FLU3~PFIZER\WYETH~4008178~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164791	01/17/2001	MI	68.0	68		F	12/27/2000	The pt's left arm began to swell shortly after receiving the vaccines. The pt saw an internist on 12/20/00. The pt was treated with Benadryl and Allegra. The arm continues to itch and the swelling is decreasing.				Y					Y	12/19/2000	12/19/2000	0		PUB	PUB	Coumadin				MI2001001	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4008224~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0690K~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0163704	01/18/2001	CO	42.0	42		F	11/27/2000	Tingling, numbness on same side of body as flu shot for 3 weeks. Large, red, hot, lump at injection site for 5 days. Tingling and numbness progressed to bilateral full body. At 3 weeks, became Bell's Palsy, right-sided and still being treated with steroids and symptoms are persisting.				Y					N	11/01/2000	11/01/2000	0	CBC, CMP, MRI Brain	PVT	PVT	NONE	NONE	Allergy to sulfa medications		CO0028	1						2	Facial palsy; Injection site erythema; Injection site mass; Injection site warmth; Paraesthesia	FLU3~AVENTIS PASTEUR~U0399AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0164557	01/18/2001	WI	80.0	79		F	11/22/2000	The pt called the assistant director and informed her that the pt was hospitalized after receiving the vaccines for congestive heart failure.				Y	Y	3			Y	11/09/2000	11/09/2000	0	NONE	OTH	PUB	K-Dur, aspirin, Vasotec, Glucotrol XL	NONE	CHF, NIDDM, HTN		WI0105	1						2	Cardiac failure congestive; Cardiac failure congestive; Condition aggravated	FLU3~PFIZER\WYETH~4008174~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~463717~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~U0266BA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4008174~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~PFIZER\WYETH~463717~UNK~IM~LA~PNEUMO (PNU-IMUNE)~2|TD~CONNAUGHT LABORATORIES~U0266BA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0164784	01/18/2001	VA	40.0	40		F	12/15/2000	Immediately after vaccine, patient developed numbness in her right arm, discoloration of the arm and swelling in the right hand. Her face was flushed. By 10:30AM, a red rash had appeared on her face, ears and neck. Her blood pressure was 163/103 and she had a rapid pulse at 103-105. Her clinical diagnosis was anaphylactic reaction to flu vaccine. She was treated with Benadryl, 25mg po.				Y					Y	12/15/2000	12/15/2000	0		PUB	PUB	Synthroid	NONE	Hypothyroid, allergy to sulfa	Numbness lt arm~Influenza (Seasonal) (no brand name)~~38.00~In Patient	VA01001	1						2	Anaphylactic reaction; Erythema; Heart rate increased; Hypertension; Hypoaesthesia; Oedema peripheral; Pallor; Rash; Skin discolouration; Anaphylactic reaction; Flushing; Heart rate increased; Hypertension; Hypoaesthesia; Injection site reaction; Oedema peripheral; Rash; Skin discolouration	FLU3~PFIZER\WYETH~4008180~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4008180~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0164835	01/18/2001	MI	37.0	37		F	01/05/2001	The employee was given the flu vaccine at approximately 10:45 and within 15 minutes experienced a rash, tightening of the throat, wheezing and difficulty breathing. The pt was treated with epinephrine and Benadryl. Called 911 for transport to the hospital. After receiving medications, breathing improved. The type of reportable event was anaphylactic reaction.					Y				Y	12/12/2000	12/12/2000	0		UNK	UNK			hx of asthma (seasonal)			1						1	Anaphylactic reaction; Dyspnoea; Rash; Throat tightness; Wheezing; Anaphylactic reaction; Dyspnoea; Rash; Wheezing; Anaphylactic reaction; Dyspnoea; Rash; Throat tightness; Wheezing	FLU3~PFIZER\WYETH~4008181~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4008181~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|FLU3~PFIZER\WYETH~4008181~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~3	USA	Hospitalisation	Influenza
0164852	01/18/2001	TX	1.25	1	.3	M	01/04/2001	Patient developed a 10 cm red, indurated, warm area over the left thigh where he received the DTAP/Hib combination.									Y	12/05/2000	12/06/2000	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site warmth	DTAP~CONNAUGHT LABORATORIES~4024966(A)~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~AVENTIS PASTEUR~40428AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~CONNAUGHT LABORATORIES~4024966(B)~4~IM~LL~HIB (ACTHIB)~1|IPV~CONNAUGHT LTD.~T0471~3~~LL~POLIO VIRUS, INACT. (POLIOVAX)~1|PNC~PFIZER\WYETH~473811~1~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0164860	01/18/2001	MI	26.0	26		F	01/15/2001	In the PM of 01/11/01, patient's left deltoid area became reddened and swollen with a burning sensation. This increased overnight, and by 9AM on 01/12/01, the area involved was red and about 4cm oval. Patient took 2 ibuprofen (400mg) once on 01/12/01 and did not receive any other treatment. On 01/15/01, there was no redness, swelling, or burning sensation.									Y	01/11/2001	01/11/2001	0	NONE	UNK	UNK	Glucophage, Paxil	NONE	NONE	~Influenza (Seasonal) (no brand name)~1~23.00~In Patient		1						1	Injection site erythema; Injection site swelling; Skin burning sensation	FLU3~AVENTIS PASTEUR~UO460AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~5169A2~1~IM~RA~HEP B (ENGERIX-B)~1	USA		Influenza
0164861	01/18/2001	NY	5.0	5		F	01/10/2001	Patient developed erythematous, generalized, somewhat itchy rash 72 hours after flu vaccine. Follow-up on day 5 showed a generalized, papular macular erythematous rash that was mildly raised.				Y					Y	01/05/2001	01/08/2001	3	NONE	OTH	PUB	NONE	NONE	Asthma			1						1	Rash erythematous	FLU3~MEDEVA PHARMA, LTD.~E65630HA~4~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0164862	01/18/2001	NV	45.0	45		F	01/09/2001	Patient noted heaviness in chest and had to take deep breaths to feel she was getting any oxygen. She had an erratic heartbeat and could feel it jumping. She was pale with red eyes. Chest heaviness and erratic heartbeat were relieved by the morning of 01/06/01. Patient reported no wheezing or sore throat.									Y	01/05/2001	01/05/2001	0	NONE	PUB	OTH	NONE	NONE	NONE		NV01	1						1	Chest pain; Heart rate irregular; Hyperventilation; Ocular hyperaemia; Pallor	FLU3~AVENTIS PASTEUR~UO465AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164863	01/18/2001	IA	45.0	45		F	01/12/2001	Patient developed arm discomfort at site of injection for one month post administration. No medical treatment was sought. Patient took anti-inflammatory medication and used heat.										12/13/2000	12/16/2000	3		UNK	UNK						1						1	Injection site pain	FLU3~AVENTIS PASTEUR~UO447AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164864	01/18/2001	IA	35.0	35		F	01/12/2001	Patient developed arm discomfort at site of injection one month post administration. No medical treatment was sought. Patient took over-the-counter pain relievers. There was no disability or inability to use the arm.										12/13/2000			UNK	OTH	PVT	UNK	UNK	UNK			1						1	Injection site pain	FLU3~AVENTIS PASTEUR~UO447AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164865	01/18/2001	WI	57.0	57		M	01/01/2001	One day post vaccine, the patient felt spaced out, like in a different reality. Patient noted that he takes about 15 vitamin pills.									Y	12/14/2000	12/15/2000	1		OTH	UNK	NONE	NONE	NONE			1						1	Feeling abnormal	FLUX~UNKNOWN MANUFACTURER~~5~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0164866	01/18/2001	MD	45.0	45		F	01/08/2001	Patient noted to have rash on both arms and chest that became itchy.									Y	11/17/2000	11/18/2000	1		PUB	PUB					NJ200026	1						1	Rash pruritic	FLU3~AVENTIS PASTEUR~UO408CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164867	01/18/2001	IA	10.75	10		M	11/27/2000	11/20/00 Patient developed stiff neck. He had no fever. Upon movement, his neck was supple, but he had pain in the muscles of his neck and had a hard time holding his neck up. His leg extension test was normal. There was no adenitis. The doctor's impression was muscle inflammation from viral infection, possibly related to his recent flu shot.				Y						11/17/2000	11/19/2000	2		PVT	PVT	Flovent, Maxair	NONE	Asthma		ID00053	1						1	Musculoskeletal stiffness; Myalgia; Myositis; Neck pain; Viral infection	FLU3~PFIZER\WYETH~4008177~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0164868	01/18/2001	MA	43.0	42		M	01/09/2001	Approximately 3 hours after vaccine, patient developed filmy, blurry eyes with a slight discharge from the inner corners. Patient noted blurring of vision in both eyes and eyes felt strange. Upon awakening, eyes were crusty and very bloodshot. The symptoms lasted all day and ended within 24 hours.									Y	12/09/2000	12/09/2000	0	NONE	OTH	PVT	NONE	NONE	Annual response to poison ivy			1						1	Eye discharge; Eye disorder; Vision blurred	FLU3~AVENTIS PASTEUR~UO460AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164869	01/18/2001	OR	45.0	45		M	01/09/2001	Patient developed onset of right parascapular pain on 12/2/00. He had onset of right hand weakness and incoordination on 12/6/00. Specifically, he had weakness of the thumb and abduction of fingers with decreased pinch and grip strength. Tentative diagnosis is brachial plexitis.				Y					U	10/10/2000	12/02/2000	53	C-spine MRI not significant, brain MRI pending, considering MRI of brachial plexus.	OTH	OTH	lisinopril	NONE	Hypertension			1						1	Asthenia; Coordination abnormal; Muscular weakness; Nervous system disorder; Shoulder pain	FLU3~MEDEVA PHARMA, LTD.~E67930KA, E6794~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0164870	01/18/2001	TX	63.0	63		F	01/08/2001	Patient developed pain, discomfort and immobility in left arm and sought medical care. She was referred to a sports medicine clinic for evaluation and possible physical therapy. Patient's husband reported to County Health Dept on 1/2/01.				Y					U	11/01/2000				PUB	UNK						1						1	Discomfort; Hypokinesia	FLU3~PFIZER\WYETH~4008173~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~469133~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0164871	01/18/2001	CA	29.0	29		M	01/02/2001	Patient noted to be feeling faint and weak. Patient had questionable diagnosis of vasovagal syncope.									Y	12/28/2000	12/28/2000	0		PVT	UNK			History of mental retardation and asthma			1						1	Asthenia; Dizziness; Syncope vasovagal	FLU3~PFIZER\WYETH~4008197~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164872	01/18/2001	CT	30.0	30		F	01/12/2001	Patient developed redness, itching, and swelling from elbow to top of upper arm. Patient still had symptoms 4 days after the vaccine but was improving.									N	01/08/2001	01/08/2001	0		OTH	PUB	Allese	NONE	Bee sting, wine and champagne allergies			1						1	Injection site erythema; Injection site swelling; Pruritus	FLU3~AVENTIS PASTEUR~40460AA~4~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164873	01/18/2001	WI	8.0			F	01/08/2001	Patient noted swelling in left arm twenty four hours after receiving vaccine. During 1/6/01 exam, right deltoid showed a non-tender, red, warm circle 8cm x 6.5cm. She was treated with Benadryl and cool compresses.				Y					Y	01/04/2001	01/05/2001	1		PVT	PVT		NONE	Amox			1						1	Injection site erythema; Injection site warmth; Swelling	FLU3~PFIZER\WYETH~4008207~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0164874	01/18/2001	ID	45.0	45		F	12/20/2000	Patient developed left arm and shoulder pain.									U	12/19/2000	12/19/2000	0		OTH	PVT	NONE	NONE	NONE		ID00056	1						1	Injection site pain; Shoulder pain	FLU3~PFIZER\WYETH~4008220~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164875	01/18/2001	CA	31.0	31		M	01/02/2001	Patient started feeling dizzy and sick. While caretaker was trying to get him into the car, he had a seizure and wet himself. He recovered from the seizure. Patient was diagnosed with vaccine flu reaction, questionable seizure and vasovagal syncope.				Y					Y	12/28/2000	12/28/2000	0		PVT	UNK		NONE	History of mental retardation and expressive language disorder			1						1	Convulsion; Dizziness; Hypersensitivity; Malaise; Syncope vasovagal; Urinary incontinence	FLU3~PFIZER\WYETH~4008197~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0164876	01/18/2001	WI	85.0	85		F	12/28/2000	On the day after receiving vaccine, patient developed symptoms similar to those she had years ago when she had an allergic reaction to PNC. Her symptoms included bilateral lower leg pain and weakness. By the time she visited her doctor two days later, she was wheelchair bound and remained in this weakened state for about 1 week. Her legs are still a bit weak, but she exercises them daily and has no permanent problems.				Y						10/09/2000	10/10/2000	1	Serum sickness test	PUB	PUB	Vioxx, Tenormin, HRT, Claritin-D, Procardia	NONE	Chronic lung, cardiac and arthritis problems. Also many allergies including PNC, morphine, codeine and Lomotil		WI0102	1						1	Muscular weakness; Pain	FLU3~MEDEVA PHARMA, LTD.~E67390KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0164878	01/18/2001	MT	49.0	49		M	01/10/2001	Patient noted 20-30 flat, non-raised, red blotches on his chest, back, and legs approximately 24 hours after receiving vaccine. The spots were about 1/2 the size of a dime. Patient also reported periods of slight lightheadedness.									Y	01/09/2001	01/10/2001	1	NONE	OTH	PUB	Occasionally uses an inhaler prior to exercise	A RESOLVING COLD	Mild asthma, allergic to penicillin			1						1	Dizziness; Erythema; Rash macular	FLU3~AVENTIS PASTEUR~UO333AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164879	01/18/2001	MT	53.0	53		M	01/11/2001	Patient developed nausea and vomiting, weakness, tightness in throat, and itchy hives all over his body approximately 1.5 hours after receiving vaccine. He took 7-Up for his nausea. Patient called his doctor on 12/21/00 and was told if the hives persisted on 12/22/00 then he should call the doctor again. Patient stated the hives were gone as of 12/22/00.									Y	12/19/2000	12/19/2000	0	NONE	OTH	PUB		NONE	Left arm weakness			1						1	Asthenia; Nausea; Pruritus; Throat tightness; Urticaria; Vomiting	FLU3~AVENTIS PASTEUR~UO453AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~468136~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0165143	01/18/2001	CO	51.0	51		F	11/17/2000	Before leaving the doctors office, the pt told the clerk that her chest felt tight and the clerk notified the RN. The pt stated that the tightening occurred suddenly. They loosened clothing and had the pt lie down. The tightness continued and her throat began to feel numb. Her color remained pink. 911 was called. Treated with epinephrine and transported to the hospital.				Y					Y	11/13/2000	11/13/2000	0	P-96, BP 162/92	PUB	PUB	Serevent, Flovent, Albuterol, Verapamil, Flexeril	NONE	allergies		CO0024	1						1	Chest discomfort; Hypertension; Hypoaesthesia	FLU3~AVENTIS PASTEUR~U0416FA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0690K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0161032	01/19/2001	PA	38.0	38		F	10/13/2000	Approximately 8:40 the school nurse was called to the auditorium, the pt was unresponsive, staring, (not unconscious). At 8:45 her BP was 180/94, pulse 104 and respirations were 20. She seemed unable to speak, unresponsive to painful stimulation. No difficulty breathing was noted. The pt complained of heaviness of of arm and legs. The pt was unable to move legs, and felt a little tightness in chest. The ambulance arrived and the pt complained of nausea and she started staring and became unresponsive again. She was transported to the ER. She was then discharged home.				Y					Y	10/09/2000	10/09/2000	0	EKG, blood work, urinalysis	OTH	PVT		NONE	NONE			1						2	Chest discomfort; Coma; Hypertension; Hypokinesia; Nausea; Respiratory rate increased; Sensation of heaviness; Speech disorder; Staring	FLU3~AVENTIS PASTEUR~U0335AB~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0161979	01/19/2001	PA	69.0	69		F	11/13/2000	Patient developed a raised, red rash on her chest, neck, groin, and inner arms. This was not itchy. There were no respiratory symptoms. Patient made a telephone call and visited her physician. She was treated with prednisone. The rash was fading as of 11/13/00.				Y						11/06/2000	11/07/2000	1		PUB	PUB					PA0103	1						3	Rash erythematous	FLU3~MEDEVA PHARMA, LTD.~E59070GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~3	USA	Emergency room visit	Influenza
0162664	01/19/2001	PA	71.0	71		M	11/21/2000	On 11/16/00, at 3 AM the patient was experiencing itchiness to the groin, stomach, legs, progressing to the neck and chest; no rash. On 11/20/00, the itching continues. Calamine lotion and Benadryl over the counter items will provide temporary relief. On 11/21/00, the physician prescribed over the phone  Hydroxycine HCL, good relief provided.									Y	11/15/2000	11/16/2000	1		PUB	PUB		NONE	NONE		PA0105	1						3	Pruritus	FLU3~MEDEVA PHARMA, LTD.~E59070GA~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~3	USA		Influenza
0164917	01/19/2001	MD	60.0	60		F	01/11/2001	The pt experienced flu symptoms, shortness of breath, chest congestion, runny nose, constant cough, muscle aches etc. Still very sick.				Y	Y	2			N	01/05/2001	01/05/2001	0		PUB	PVT	NONE	NONE	NONE			1						1	Cough; Dyspnoea; Influenza like illness; Malaise; Myalgia; Nasal congestion; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0164918	01/19/2001	MD	32.0	32		F	01/09/2001	The evening of the vax, while lying down to sleep, the pt noticed itching on buttocks and feet were burning. The next day around 2:00 pm, the pt complained of feet were burning and parts of my skin all over my body was itching. She called the MD for advice. She was told to take 2 Benadryl and drink lots of water and to lay her feet on frozen bags with towels around them. The pt complied but still had itchy whelps and rashes that were huge. The follow day, the breakout began in different places on the body. The pt then experienced a swollen tongue. She called her MD, but was placed on hold for a long period of time and then decided to call an ambulance and was taken to the hospital. She was given steroids, after which the intense itching stopped. The pt then experienced boils between her legs where she sits. The boil turned into a huge abscess which had to be lanced and packed twice (different days) in which she received no medication to relieve the pain. The abscess covered a large area between her legs, about the size of a naval orange. The pain traumatized the pt. She has been a diabetic for about 2 years and has never experienced anything like this before. The pt has never had adverse reactions to vaccinations prior to this. The pt believes the flu shot was a large part of her pain because the smell of the abscess was like rotten eggs plus the MD who performed the lancing told her that the steroids would have produced the boil. In conclusion, the pt will never take the flu vaccine again.			Y	Y					Y	12/15/2000	12/15/2000	0		PUB	UNK		Diabetes	diabetes			1						1	Abscess; Furuncle; Pruritus; Rash; Skin burning sensation; Tongue oedema; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0164926	01/19/2001	MS	36.0	36		F	01/11/2001	Shortly after vax the pt felt lightheaded, became pale and nearly fainted. She sat in a chair with her head between knees for about 10 minutes then went back to work. A couple hours later it was reported that she felt much better and that it had happened last year when she got  her flu shot. She also stated she was having joint pain and swelling in her right hand and could hardly use it. She stated she could bare get up and down from sitting and had difficulty walking. It was advised that she doesn't take the vaccine again.									Y	11/21/2000	11/21/2000	0	NONE	PVT	PVT						1						1	Arthralgia; Difficulty in walking; Dizziness; Hypokinesia; Oedema peripheral; Pain; Pallor; Similar reaction on previous exposure to drug; Vaccine positive rechallenge	FLU3~PFIZER\WYETH~4008183~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164928	01/19/2001	WY	67.0	67		F		24 hours post vax the pt noticed a ver foul odor much like rotten eggs. Nothing would eradicate this nauseating odor 24 hours a day. After 24 more hours the pt experienced a severe headache and general muscle aches. These symptoms lasted about 2 weeks. The pt had a reoccurrence of the foul odor occasionally for 1 month following the vax.				Y					Y	11/20/2000	11/21/2000	1		PUB	UNK						1						1	Headache; Myalgia; Nausea; Parosmia	FLU3~AVENTIS PASTEUR~U0417AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0164929	01/19/2001	PA	59.0	59		F	12/22/2000	One day post vax, the pt started itching which lasted most of the day. It itched like dry skin, the pt used lotion. The next day, the pt woke up with itching with hives on the buttocks, sides and back, abdomen and top of legs and waist line. Ears were hot and swollen. Took Benadryl. Hives lightened. Was taken to the ER.				Y					Y	12/20/2000	12/21/2000	1		OTH	PUB	Proventil inhaler, Prempro, Celebrex	passed out at work			PA0113	1						1	Face oedema; Feeling hot; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4008224~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0164930	01/19/2001	PA	64.0	64		F	12/12/2000	The pt experienced a blotchy raised rash on chest only, with itchiness. It was irritated by clothing. No respiratory symptoms. The rash faded but did not disappear. It reoccurred on 11/26/00. The pt took Benadryl for some relief. On 12/11 the rash faded.									Y	11/17/2000	11/18/2000	1		PVT	PVT					PA0112	1						1	Erythema; Pruritus; Rash; Rash maculo-papular	FLU3~MEDEVA PHARMA, LTD.~E59070GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0164931	01/19/2001	PA	77.0	77		M	11/30/2000	The pt complained of pain in his neck approximately 20 minutes post vax as he was getting into his car. 24 hours later he still experienced pain associated with movement of his head. Has had similar pain in the past, but not this bad.									U	11/29/2000	11/29/2000	0		PUB	PUB	Allegra	NONE	NONE		PA0111	1						1	Hypokinesia; Neck pain; Pain; Vaccine positive rechallenge	FLU3~PFIZER\WYETH~4008180~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164932	01/19/2001	MO	4.0	4		M	01/08/2001	The pt experienced 8-10 episodes of blinking eyes and upward eyebrow movements without loss of consciousness without staring and without loss of continence.									U	01/04/2001	01/05/2001	1		PVT	PUB			chronic middle ear infection with bilateral tube placement	blinking eye movements~Influenza (Seasonal) (no brand name)~1~3.50~In Patient		1						1	Gaze palsy	FLU3~AVENTIS PASTEUR~U0421AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0865K~2~IM~LA~HEP A (VAQTA)~1	USA		Influenza
0164933	01/19/2001	MI	24.0	24		F	01/03/2001	5 minutes following vax while driving, the pt felt a hot burning sensation go up her arm ant hen throughout her whole body. The pt complained of a loss of peripheral vision. When getting out of her car she became dizzy and nauseated and began stumbling. The pt went to the ER by ambulance. The pt was diagnosed with an adverse flu shot reaction. No further problems as of this date.				Y					Y	12/21/2000	12/21/2000	0	NONE	PUB	PUB	Birth control pills, Paxil	NONE	NONE			1						1	Dizziness; Gait disturbance; Hypersensitivity; Nausea; Skin burning sensation; Visual field defect	FLU3~PFIZER\WYETH~4008213~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0164966	01/22/2001	CA	20.0	20		F	01/09/2001	The pt experienced a headache within 15 minutes of vax. The pt also experienced weakness in arms, injection site sore (left more than right), muscle aches, dizziness, vomiting and nausea.									Y	12/21/2000	12/21/2000	0	NONE	PVT	PVT		NONE				1						1	Asthenia; Dizziness; Headache; Injection site pain; Myalgia; Nausea; Vomiting	FLU3~PFIZER\WYETH~4008202~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~SMITHKLINE BEECHAM~5169A2~5~IM~LA~HEP B (ENGERIX-B)~1	USA		Influenza
0164967	01/22/2001	WI	25.0	24		M	01/11/2001	The pt developed a hoarse voice lasting about 12 hours, rash all over whole body, blotchy spots, noticed the next morning. Duration of 24 hours.									Y	01/10/2001	01/11/2001	1	NONE	OTH	PVT		NONE	NONE			1						1	Dysphonia; Rash; Rash macular	FLU3~PFIZER\WYETH~4008201~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0164968	01/22/2001	PA	4.0	4		M	01/15/2001	The pt experienced severe pain in his right shoulder with swelling. 2 days later it had improved. No treatment needed.									Y	01/10/2001	01/11/2001	1	NONE	PVT	UNK		NONE	asthma, chronic otitis media			1						1	Injection site oedema; Injection site pain	FLU3~AVENTIS PASTEUR~U0434AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0944K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0164969	01/22/2001	OH	68.0	68		F	01/10/2001	The pt experienced a swollen arm from shoulder to wrist. It was painful and then a day later turned red all over. Could not bend or reach with arm. Felt sick, had a fever and chills along with night sweats and coughing and some itching.				Y					Y	12/14/2000	12/14/2000	0		PVT	UNK	Zocor, synthroid, Rozimax	NONE	high cholesterol, hypothyroid			1						1	Cough; Erythema; Hypokinesia; Malaise; Night sweats; Oedema; Pain; Pruritus; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~E72410LA~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~468136~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0165073	01/23/2001	NH				U	01/19/2001	A territory representative reported that a pt received an injection and subsequently developed flu-like symptoms. The pt was hospitalized. The reporter indicated that 11 pts experienced this event however they are not presently identifiable. Additional reports will be generated when identifying information is provided.					Y				U				UNK	OTH	OTH	UNK	UNK	UNK		HQ6140219JAN2001	1						1	Influenza like illness	FLU3~PFIZER\WYETH~4998212~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0165089	01/23/2001	WA	45.0	45		F	01/19/2001	Pt developed extensive hives all over body, was relieved with diphenhydramine.									Y	01/12/2001	01/13/2001	1		PVT	PVT		NONE	Sulfa			1						1	Urticaria	FLU3~PFIZER\WYETH~4008225~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165090	01/23/2001	CA	32.0	32		F	01/11/2001	Pt experienced bruising at injection site for two weeks post vax. Pts arm is continuously sore at the site and the muscles ache constantly. Area is very sore.										12/13/2000	12/13/2000	0	NONE	PUB	UNK						1						1	Injection site haemorrhage; Injection site pain; Myalgia	FLU3~PFIZER\WYETH~4008202~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165091	01/23/2001	FL	72.0	72		M	01/08/2001	Pt experienced a sore neck for 10 days; chills/fever and congestion for 3 days; both wrists and knees were sore a swollen for 3 days; soreness at the bottom of rib cage for 21 days; constipation and loss of appetite for 14 days; and ears were plugged up for 21 days.									Y	12/08/2000	12/09/2000	1		PVT	UNK		NONE	NONE			1						1	Anorexia; Constipation; Ear discomfort; Joint swelling; Nasal congestion; Neck pain; Pyrexia	FLU3~AVENTIS PASTEUR~U0443AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0165092	01/23/2001	MN	69.0	69		F	01/16/2001	Within one day post vax, the pts left upper arm was red, swollen and warm to the touch. By that afternoon it had spread to the forearm as well. Pt treated with Riaxin for 10 days.				Y					Y	01/05/2001	01/06/2001	1		OTH	PUB		NONE				1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0165093	01/23/2001	AR	4.0	4		M	12/18/2000	Pt developed raised red bumps on face and trunk one day post vax that last for 10 days.									Y	11/17/2000	11/18/2000	1	NONE	PUB	PUB	NONE	NONE	NONE		AR0105	1						1	Rash	FLU3~AVENTIS PASTEUR~U0421AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0165094	01/23/2001	CA	77.0	77		F	11/29/2000	Pt reported experiencing difficulty lifting her left arm since receiving the vax. The arm is in a lot of pain.									N	11/06/2000				PUB	PUB	UNK	NONE	diabetes; alzheimers disease; heart problems		CA000161	1						1	Hypokinesia; Pain	FLU3~MEDEVA PHARMA, LTD.~E67380KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0165095	01/23/2001	NV	66.0	66		F	12/14/2000	Pt developed hives and a thick tongue.				Y					U	11/03/2000	11/13/2000	10		OTH	UNK						1						1	Tongue disorder; Urticaria	FLU3~AVENTIS PASTEUR~U0344AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0944K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0165096	01/23/2001	MA	53.0	53		F	01/15/2001	Approximately 24 hours post vax the pt developed a fine red rash on both forearms from the elbows to the wrists, very itchy.  Pt was seen by physician and treated with Prednisone and Benadryl for 5 days. The rash subsided in about one week with no recurrence.									Y	11/15/2000	11/17/2000	2	NONE	PUB	PUB	Pepcid; Topidol; Lipitor		cardiac cath stint; hypertension; diabetes type II; increased cholesterol			1						1	Erythema; Pruritus; Rash	FLU3~AVENTIS PASTEUR~U0346AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0165097	01/23/2001	CA	61.0	60		F		Pt developed Bells Palsy. Treated with Prednisone.				Y					Y	11/06/1999	11/22/1999	16	MRI negative	PVT	UNK	Prozac; Vicodan; Areida; MS Contin	Metastatic breast cancer	Sulfa allergy; cancer			1						1	Facial palsy	FLU3~CONNAUGHT LABORATORIES~U0167AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0165098	01/23/2001	AZ	33.0	23		F	01/16/2001	Pt experienced pain radiating from right deltoid area.									Y	01/06/2001	01/06/2001	0		MIL	MIL						1						1	Injection site pain	FLU3~PFIZER\WYETH~U0403AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163488	01/24/2001	WI	66.0	65		M	01/18/2001	The pt experienced an elevated temp of 102.4 and a very sore arm. The pt took 2 325mg aspirin.									Y	11/27/2000	11/27/2000	0	NONE	PUB	PUB	vitamin C-E, verapamil 360 mg	NONE				1						2	Injection site pain; Pyrexia	FLU3~PFIZER\WYETH~4008175~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~UNKNOWN MANUFACTURER~~UNK~IM~~PNEUMO (NO BRAND NAME)~2	USA		Influenza
0165157	01/24/2001	MO	2.2	2	.2	M	01/16/2001	On 1/7/01, the child presented at this physician's office with a temperature of 103 and a papillary rash on arms, legs, and slightly on the trunk. Additional information was received stating that while the child was in the office he required two breathing treatments for his asthma and was found to have infiltrates in his lungs. The child has since been dx with pneumonia and a bacterial infection in the blood.				Y					U	01/03/2001	01/07/2001	4		OTH	OTH	NONE		asthma		MPI2001000170	1						1	Asthma; Bacterial infection; Condition aggravated; Pneumonia; Pyrexia; Rash	FLU3~MEDEVA PHARMA, LTD.~E599600A~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0165181	01/24/2001	HI	32.0	32		M	01/07/2001	The pt experienced urticaria on face, back, neck and chest. Treated with meds.									U	01/07/2001	01/07/2001	0		MIL	MIL			NONE			1						1	Urticaria	FLU3~PFIZER\WYETH~4008215~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165182	01/24/2001	MO	62.0	62		F	01/17/2001	The pt experienced right arm swelling, pain too bad to move. The next day, the arm was red and a rash appeared from shoulder to the elbow.									Y	01/05/2001	01/05/2001	0		PUB	PVT						1						1	Hypokinesia; Injection site erythema; Injection site oedema; Pain; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0165183	01/24/2001	GA	36.0	36		F	01/17/2001	5 minutes post vax, the pt developed throat tightness, hot flushing, feeling faint, treated with epinephrine twice and also Benadryl and oral prednisone.				Y					Y	01/17/2001	01/17/2001	0		MIL	UNK	Flagyl	bacterial vaginosis	NONE			1						1	Feeling hot; Flushing; Syncope; Throat tightness	FLU3~PFIZER\WYETH~4008210~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TYP~CONNAUGHT LABORATORIES~R0300~2~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0165184	01/24/2001	OK	22.0	22		F	01/18/2001	The pt experienced a severe local reaction at the injection that was painful and with an 8 x 4 cm area of erythema and induration.				Y					U	01/16/2001	01/16/2001	0	UNK	MIL	MIL		NONE	allergy to azithromycin			1						1	Injection site erythema; Injection site induration; Injection site pain	FLU3~PFIZER\WYETH~4008287~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0165185	01/24/2001	WI	49.0	49		F	01/10/2001	30 minutes post vax, the pt complained of site redness, swelling and itching. The area was 3cm x 2 1/2cm that was warm and elevated. No systemic symptoms. Lung are clear. Treated with Benadryl.									Y	01/09/2001	01/09/2001	0	BP - 110/72, P-66	OTH	PUB	estrogen patch	NONE	NONE			1						1	Hyperventilation; Injection site erythema; Injection site oedema; Injection site swelling; Injection site warmth; Pruritus	FLU3~MEDEVA PHARMA, LTD.~E64500HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0165186	01/24/2001	CA	55.0	55		M	01/17/2001	The pt experienced a high fever on 12/28/00 to 1/1/01, chest tightness and hard to breathe from 12/28/00 to 12/29/00. The pt experienced weakness from 12/28/ to 1/13, hoarseness from 12/29 to 1/5 and muscle aches from 12/28 to 1/5.									Y	12/28/2000	12/29/2000	1		PVT	UNK		NONE	NONE			1						1	Chest discomfort; Dysphonia; Dyspnoea; Hypotonic urinary bladder; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0165187	01/24/2001	KY	68.0	68		F	01/17/2001	The pt experienced pain at the injection site which increased to pain of the entire right arm with swelling. That night had chest pain and the next day this became more severe with swelling of the face. 2 days later the pt developed swelling of the right neck, nausea, blurred vision with the right arm still aching.				Y					Y	01/08/2001	01/08/2001	0		PUB	PUB			allergy to sulfa, lupus, cirrhosis of liver, diverticulitis, asthma		KY2001004	1						1	Chest pain; Face oedema; Injection site oedema; Injection site pain; Nausea; Vision blurred	FLU3~PFIZER\WYETH~4008206~5~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0165188	01/24/2001	WI	44.0	44		F	01/17/2001	15 hours post vax the pt went to the ER with upper back pain and chest pain. Heart and lungs were checked and were ok. Was told it was muscular pain most likely from the flu shot. Was given pain medication.				Y					Y	12/20/2000	12/21/2000	1		PUB	PVT		NONE				1						1	Back pain; Chest pain; Myalgia	FLU3~AVENTIS PASTEUR~U0444AB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0165231	01/25/2001	IL	24.0	24		F	12/04/2000	The patients arm was sore 4-5 days after vaccine, 11/30. It began to hurt again to touch or lifting arm above head. The patient continues today 12/04/00. Prescribed Tylenol; the site with out warmth, redness, or edema. Did notice 15 minute episode of tingling in fingers.				Y					N	11/21/2000	11/30/2000	9		OTH	PVT	NONE	NONE	Latex gloves			1						1	Injection site pain; Pain; Paraesthesia	FLU3~AVENTIS PASTEUR~U04160A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0165232	01/25/2001	OH	65.0	65		M	01/17/2001	This patient under went a total knee arthroplasty 12/06/00. Prior to receiving the vaccine on 12/07/00 his temperature was 101F. Two hours after the vaccine his temperature was 102F. Two and a  half (2 1/2) hours after the vaccine his temperature was 105F. The patient was confused and experienced nausea and vomiting. Preadmission testing done prior to surgery revealed normal CBC and urinalysis, blood cultures done at 6:50 PM were positive for E.coli. The patient was treated with IV Rocephin and was released to home 12/09/00.									Y	12/07/2000	12/07/2000	0	CBC and urinalysis - Nml. Blood cultures - positive for E.coli.	PUB	UNK			No known allergies. Positive for arthritis, decreased thyroid disease.			1						1	Confusional state; Infection; Nausea; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~4008190~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165233	01/25/2001	MD	56.0	56		F	01/18/2001	The patient has pain in injection site since shot was given, no redness or swelling.				Y					N	11/02/2000	11/02/2000	0		PVT	PVT	Atenolol, Prilosac	Left arm pain x 2 mos	Hypertension, borderline Diabetic, borderline Lupus			1						1	Injection site pain	FLU3~MEDEVA PHARMA, LTD.~E65610HA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0165234	01/25/2001	VA	51.0	51		M	01/16/2001	This patient had vaccine administered 01/09/01 at 1:45 PM. The client noted red , slightly raised rash on knees and arms. On 01/11/01 he also noted pimplish rash on thighs and calves, lymph nodes inflammed, no temperature noted. History of cold one week prior to Christmas, progressed to sinus infection. Last dose of Amoxicillin was 01/05/01. Took Pseudoephedrine on 01/09/01 and 01/10/01.				Y					Y	01/09/2001	01/11/2001	2	NONE	PUB	PUB	Lipitor, Allopurinol. Last dose of Amoxicillin 01/05/01.	Recovering from sinus infection	Allergic to bee stings, Hay fever, History of High Cholesterol, history of gout		VA01002	1						1	Infection; Pharyngitis; Rash erythematous; Rhinitis	FLU3~PFIZER\WYETH~4008205~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0165235	01/25/2001	AL	70.0	70		F	10/20/2000	This patient was given the Flu vaccine in the left deltoid and Pneumovac in the right deltoid approximately 9:55 AM on 10/10/00. Within 3-5 minutes after injections the patient complained of bilateral sites of injection itching. There was a red area at the site of the Flu vaccine quarter size. Red area 1 1/2 inch at the site Pneumovac injection. The patient states sometimes my skin is more sensitive than other, she also states I feel fine. The patient went to see his physician who ordered ice to be applied, Benadryl 25 mg given as ordered, 2nd Benadryl 25 mg to take 4-6 hours later.									Y	10/10/2000	10/10/2000	0		PVT	UNK	Ativan, Provera, Tylenol, Estrace, Fioricet,  Keflex, Levsin, Atenolol.			Patient complains of history of arm discomfort~Tetanus Toxoid (no brand name)~~0.00~In Patient		1						1	Injection site erythema; Injection site hypersensitivity; Pruritus	FLU3~AVENTIS PASTEUR~U0345AC~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0690N~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0165240	01/26/2001	MD	65.0	65		M	01/19/2001	The pt developed Guillain Barre on 12/10. Was admitted to the hospital and remains hospitalized. On 1/23/01 the prognosis for a full recovery in 2 years. Was transferred to a rehab unit on 1/16/01. Also diagnosed with sleep apnea.  Follow up on 07/09/2001: Chronic illness before includes chronic heart disease, sleep apnea, atrial fib.  			Y	Y	Y		Y		N	12/05/2000	12/10/2000	5		OTH	PVT	Coumadin, Lanoxin, Prinivil, Zocor	NONE	MI with angioplasty, endocarditis, atrial fib, HTN, CAD			1						1	Apnoea; Guillain-Barre syndrome; Respiratory disorder	FLU3~AVENTIS PASTEUR~U0441AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0165248	01/26/2001	TN	23.0	23		F	01/18/2001	The pt experienced redness, slightly swollen area with welts. States arms are sore, and chest is red.									Y	01/18/2001	01/18/2001	0	NONE	PVT	UNK	NONE	NONE	allergies			1						1	Erythema; Injection site erythema; Injection site oedema; Injection site pain; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~1~IM~RA~HEP B (NO BRAND NAME)~1	USA		Influenza
0165249	01/26/2001	MN	60.0	60		M	12/05/2000	The pt experienced left sided bells palsy				Y					Y	11/21/2000	11/22/2000	1		PVT	OTH	Ibuprofen, Vioxx	NONE	recurrent cellulitis	swelling, clamminess~Vaccine not specified (no brand name)~1~20.00~In Patient		1						1	Facial palsy	FLU3~AVENTIS PASTEUR~U0414BB~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0165250	01/26/2001	CO	14.0	14		M	11/18/2000	The pt experienced a 20 second seizure seven hours post vax.									Y	11/18/2000	11/18/2000	0	CT scan - nml, EEG, nml	PVT	OTH	NONE	seizures	NONE			1						1	Convulsion	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0165263	01/29/2001	NC	51.0	51		F	01/24/2001	One day post vax, the pt developed flu-like symptoms and had pain on the right side of her chest. The pt noted that she then went to to an emergency facility where she was diagnosed with severe bacterial pneumonia that was confirmed by cultures. She spend 9 days in the hospital where she received unspecified IV antibiotics. Therapy was switched to Keflex for 10 days once she was discharged from the hospital. ON 1/15/01, the pt returned and was subsequently diagnosed with inflammation of the pleural cavity. She was discharged. F/U her admitting dx were R upper lobe pneumonia, COPD and asthma. The pt recovered. The hospital physician did not consider this event to be secondary to vaccine administration.					Y	9			U	12/20/2000	12/21/2000	1	UNK F/U CBC w/diff, blood gases, blood chemistry, urinalysis, blood and sputum clutures anc chest x-ray were performed. WBC -4,7000 K/UL arterial blood gas results were pH at 7.477,pCO2 at 22.5 mm/mg, pO2 at 67.9 mm/hg, HC03 at 16.3 Meq/l (22-26) with a base excess at  -5.0 and oxygen sat at 95.1% on room air. urinalysis revealed a high level of bacteria, chest x-ray showed R upper lobe consolidation with honeycombin of the lung which may have been secondary to active to TB or other bacterial infections.  PPD was performed, however results were not provided.	PVT	PVT	Serevent, Vioxx, Klonopin, Prempro, Tylenol	NONE	asthma, emphysema, cough, diverticulitis, drug hypersensitivity, intervertebral disc degeneration, osteoarthritis		HQ6270423JAN2001	1						1	Asthma; Bacterial infection; Chest pain; Influenza like illness; Laboratory test abnormal; Obstructive airways disorder; Pleurisy; Pneumonia; Bacterial infection; Chest pain; Influenza like illness; Pleurisy; Pneumonia	FLU3~PFIZER\WYETH~~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0165268	01/29/2001	NY	27.0	27		F	01/11/2001	The pt experienced generalized itching and rash. Some swelling was reported on the day after vax. On 1/11/01 the pt's extremities noted to be flushed and slightly erythemic with blanching on pressure. The pt is taking Benadryl with some relief. States previous vaccine had no adverse event.									Y	01/10/2001	01/10/2001	0	NONE	PUB	PUB		NONE	migraines			1						1	Flushing; Oedema; Pruritus; Rash	FLU3~PFIZER\WYETH~4008218~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165269	01/29/2001	NY	68.0	68		M	01/17/2001	The pt complained of hives over 80 percent of body which appeared approximately 10 hours post vax. The pt used Benadryl cream and symptoms subsided. The next day the hives returned. The pt saw an MD and was diagnosed as a drug allergy. The MD prescribed Benadryl and Claritin. The pt was called and his only complaint then was edema of the lips and hands.				Y					Y	01/16/2001	01/16/2001	0		PUB	PUB		NONE	sinus problems, heart bypass		NC00006	1						1	Face oedema; Hypersensitivity; Oedema peripheral; Urticaria; Urticaria	FLU3~AVENTIS PASTEUR~U0465AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~AVENTIS PASTEUR~U0465AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0165270	01/29/2001	NY	64.0	64		M	11/15/2000	The pt experienced achiness, stomach pain, all over aches has heart problems, mild temp, pounding headaches. No diarrhea or vomiting. Went to the ER and was checked for heart problems. The pt has had a previous heart attack and thought was flu. The pt is on Cefcil, Flonase for 7 days.									Y	11/01/2000	11/04/2000	3	Blood work, EKG	OTH	PVT	Coumadin, Vasotec, Lasix, Lipitor	NONE	NONE	flu symptoms~Tetanus Toxoid (no brand name)~1~40.00~In Patient		1						1	Abdominal pain upper; Cardiac disorder; Headache; Pain; Pyrexia	FLU3~AVENTIS PASTEUR~U0415AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0165271	01/29/2001	NY	59.0	59		F	11/07/2000	The pt experienced body aches, severe soreness in the right armpit, slight elevated temp, tiredness, took Tylenol and was better the next day.									Y	11/04/2000	11/05/2000	1	NONE	OTH	PVT	estrogen therapy	NONE	allergy to sulfates and some foods			1						1	Fatigue; Lymph node pain; Pain; Pyrexia	FLU3~AVENTIS PASTEUR~U0415AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1217J~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0165272	01/29/2001	NY		46		F	11/10/2000	The pt complained of joint pain at the shoulder, elbow, wrist. No redness or swelling. The pt hasn't taken anything. Took ibuprofen over the weekend and was better on Monday.									Y	11/10/2000	11/11/2000	1	NONE	OTH	PVT	synthroid, Cardizem	NONE	arthritis			1						1	Arthralgia	FLU3~AVENTIS PASTEUR~U0400AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0165273	01/29/2001	NY	71.0	71		M	12/14/2000	The pt complained of a sore arm, chills, achy joints, temp of 100. Tylenol was recommended.									U	12/12/2000	12/12/2000	0		OTH	UNK		NONE				1						1	Arthralgia; Injection site pain; Pyrexia	FLU3~AVENTIS PASTEUR~U0436AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0165274	01/29/2001	NY	57.0	57		F	12/13/2000	The pt felt weakness, headache, diaphoresis following the vax. The pt was still not well on the following day. It was suggested that she call her MD.									U	12/12/2000	12/12/2000	0		OTH	UNK	Wellbutrin, Depakote	NONE				1						1	Asthenia; Headache; Hyperhidrosis; Malaise	FLU3~AVENTIS PASTEUR~U0436AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0165275	01/29/2001	NY	66.0	66		M	11/10/2000	The pt experienced night chills, no fever, chest congestion, dry cough. Sweats lasted 2 days. Took Advil regularly. A little better now.									Y	11/06/2000	11/06/2000	0	NONE	OTH	PVT	Lipitor, HCT, Prinivil	NONE	NONE			1						1	Chills; Cough; Hyperhidrosis	FLU3~AVENTIS PASTEUR~U0400AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0165276	01/29/2001	NY	80.0	80		F	11/08/2000	The pt complained of arm itching, area red and raised where injection given. Had an MD appt. Said to observe and call if it gets bigger. No temp.									Y	11/01/2000	11/02/2000	1	NONE	OTH	PVT	Procrit, Agralon	NONE	glaucoma, thrombopenia			1						1	Pruritus; Rash erythematous	FLU3~AVENTIS PASTEUR~U0415AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0165277	01/29/2001	NY	77.0	77		F	10/30/2000	The pt complained of a swollen arm, painful with chills the night of the vax. The chills went away when covered up. Put ice on arm. No meds.									Y	10/28/2000	10/28/2000	0	NONE	UNK	PVT	Lipitor, Dilacor	NONE	NONE			1						1	Chills; Injection site oedema; Injection site pain	FLU3~AVENTIS PASTEUR~U0415AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1217J~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0165278	01/29/2001	NY	77.0	77		M	11/07/2000	The pt experienced a swollen and red left arm. Put cold water on it and was very sore to the touch. Took ASA. The next day was still red, but not as sore.									Y	10/30/2000	10/31/2000	1	NONE	OTH	UNK	hypertension meds	NONE	allergy to red dye			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~AVENTIS PASTEUR~U0415AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1217J~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0165279	01/29/2001	NY	76.0	76		F	10/27/2000	The pt experienced a sore injection site, shivering and nausea. The pt couldn't get warm.									U	10/26/2000	10/26/2000	0		OTH	PVT	heart meds, stomach meds	NONE	NONE			1						1	Chills; Injection site pain; Nausea	FLU3~AVENTIS PASTEUR~U0415AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0710K~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0165280	01/29/2001	NY	47.0	47		M	11/03/2000	The pt experienced tenderness to the left armpit, mild aches to the knees, elbows tiredness, eyes burning, general malaise. Pain started disappearing. 2 days later symptoms had resolved.									Y	10/29/2000	10/30/2000	1	NONE	OTH	PVT	Norvasc, Diavan	NONE	NONE	pain, swelling~Tetanus Toxoid (no brand name)~~6.00~In Patient		1						1	Arthralgia; Eye pain; Fatigue; Lymph node pain; Malaise	FLU3~AVENTIS PASTEUR~U0415AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0165281	01/29/2001	NY	47.0	47		F		The pt complained of redness, tenderness, soreness for 3 days at the injection site. The pt also experienced mild aches, fatigue, no elevated temp.									Y	10/29/2000	10/30/2000	1	NONE	OTH	UNK	synthroid	NONE	NONE			1						1	Fatigue; Injection site erythema; Injection site pain; Pain	FLU3~AVENTIS PASTEUR~U0415AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0165282	01/29/2001	NY	57.0	57		F	11/03/2000	The pt was diagnosed with shingles. Her hip started to hurt. Yellow Jacket stinging, got rash, then  herpes zoster. Treated with anti viral medication. Not vaccine related.									Y	10/26/2000	10/30/2000	4	NONE	OTH	UNK	NONE	NONE	allergy to PCN and allopurinol, diagnosed with leukemia			1						1	Herpes zoster; Infection; Rash	FLU3~AVENTIS PASTEUR~U0415AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0164835	01/30/2001	MI	37.0	37		F	12/15/2000	A healthcare professional reported that a pt received an injection of Flu Shield '00-'01 on 12/12/00. That same day, the pt developed an anaphylactic reaction. No further information was available at the date of this report. Anaphylactic reaction is considered Medically Important. Follow up information received from the physician's office on 01/12/2001 indicated the patient developed a rash, wheezing, and difficulty breathing within 15 minutes after vaccine administration. The patient was treated with epinephrine and Benadryl. The patient recovered.									Y	12/12/2000	12/12/2000	0	UNK	PVT	OTH	UNK	UNK	UNK		HQ4856714DEC2000	1						2	Anaphylactic reaction; Dyspnoea; Rash; Throat tightness; Wheezing; Anaphylactic reaction; Dyspnoea; Rash; Wheezing; Anaphylactic reaction; Dyspnoea; Rash; Throat tightness; Wheezing	FLU3~PFIZER\WYETH~4008181~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4008181~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|FLU3~PFIZER\WYETH~4008181~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~3	USA		Influenza
0165304	01/30/2001	MD	73.0	73		F	01/06/2001	The pt developed ascending paralysis and Guillain Barre			Y						U	12/13/2000	12/18/2000	5	EMG, electrophoresis protein - pos for Guillain Barre	PUB	PUB	Norvasc, Arthrotec, Prevacid		allergy to PCN and sulfa		MD01001	1						1	Guillain-Barre syndrome; Paralysis; CSF test abnormal; Guillain-Barre syndrome; Hypoxia; Laboratory test abnormal; Paralysis; Antidiuretic hormone abnormality; CSF test abnormal; Guillain-Barre syndrome; Laboratory test abnormal; Paralysis; Paralysis flaccid; Pneumonia; Urinary tract infection	FLU3~PFIZER\WYETH~4008195~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1070K~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~PFIZER\WYETH~4008195~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~MERCK & CO. INC.~1070K~1~IM~RA~PNEUMO (PNEUMOVAX)~2|FLU3~PFIZER\WYETH~4008195~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~3|PPV~MERCK & CO. INC.~1070K~1~IM~RA~PNEUMO (PNEUMOVAX)~3	USA	Life Threatening	Influenza
0165305	01/30/2001	CA	14.0	14		F	01/22/2001	The pt reports waking up with numbness in both legs on 12/30/00 which had resolved and then reoccurred on 1/9/01. No weakness. Symptoms subsided and then reoccurred again on 1/19/01. FU received states final diagnosis is myelopathy.					Y				U	12/04/2000	12/30/2000	26		PVT	PUB		NONE	NONE			1						1	Hypoaesthesia; Myelopathy	FLU3~AVENTIS PASTEUR~U0441AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0165306	01/30/2001	CA	22.0	22		M	01/26/2001	Three weeks after this patient had his Influenza shot, sickness of retro-orbital pain, headache, progressive SOB and flaccid paralysis. The patient now on a ventilator, with acute disseminated Encephalomyelitis.			Y	Y	Y	5			N	01/02/2001	01/16/2001	14	CSF culture and viral PCR - neg	MIL	MIL	NONE	NONE				1						1	Dyspnoea; Encephalitis; Headache; Pain; Paralysis flaccid	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0165308	01/30/2001	FL	75.0			F	01/25/2001	Sometime following vaccination, the pt developed [[name]] Barre Syndrome. The pt was hospitalized on 1/22/01. Further information is requested. F/U correspondence rec'd on 2/27/01 additional pt and the vaccine administrator info were provided. From faxed f/u correspondence rec'd on 6/18/01 for the doctor,stated that the pt was transferred from one hospital to another hospital on 2/8/01. Teh following info was sent to the doctor on 6/26/01. Date of admission to hospital 2/9/01, date of expiration 3/28/01 at 12:28pm. Dx at time of death Guillian-Barre' syndrome immediate cause of death due to respiratory failure due to problems associated with [[name]] -Barre' syndrome.  Follow up 07/26/2001: final diagnosis was GBS.  Diagnosis was not made by a neurologist.  it is not known if the patient experienced any other illnesses previous to GBS.	Y	03/28/2001			Y				N	12/13/2000				PVT	PVT	Tiazac, Vioxx, Cozaar, Lipitor	unspecified shortness of breath	allergy to Motrin, HPTN, OA, gastritis, diverticulosis		U2001002100	1						1	Guillain-Barre syndrome; Respiratory failure	FLU3~AVENTIS PASTEUR~U0448AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0165316	01/30/2001	MD	3.0	3		F	01/24/2001	The pt experienced erythema, induration, swelling, mottling of both the upper extremities, possible cellulitis.				Y					U	01/22/2001	01/22/2001	0	NONE	PUB	UNK	NONE	NONE	asthma	facial swelling~DTP (no brand name)~1~0.25~In Patient		1						1	Cellulitis; Injection site erythema; Injection site induration; Injection site oedema; Livedo reticularis	DTAP~PFIZER\WYETH~466022~4~IM~LA~DTAP (ACEL-IMUNE)~1|FLU3~PFIZER\WYETH~4008202~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HBHEPB~MERCK & CO. INC.~1175K~UNK~IM~RA~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~472047~1~IM~RA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0165328	01/30/2001	MN	58.0	58		F	01/25/2001	The pt had a rash, was treated with Benadryl and Medrol dose pack. MD thinks the reaction was due to preservative thimerosal.									Y	01/22/2001	01/22/2001	0		PVT	PVT		NONE				1						1	Rash	FLU3~AVENTIS PASTEUR~U0455AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0165329	01/30/2001	NH	54.0	54		F	01/19/2001	5 minutes post vax, the pt complained of a temp, rapid heart beat, dizziness, not feeling well. 50-60 minutes post vax, still didn't feel well. Fingers felt clenched and tight. Still had feeling of temp.				Y					Y	01/12/2001	01/12/2001	0	BIBE	PUB	PUB	Prempro	NONE	Pt has had similar reaction when given Novocaine for dental purposes.			1						1	Dizziness; Heart rate increased; Joint stiffness; Malaise; Pyrexia	FLU3~AVENTIS PASTEUR~U0346AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0165330	01/30/2001	OR	57.0	57		F	01/18/2001	The pt experienced a 11 cm x 6cm swollen, red, warm, and itchy area. Treated with Benadryl. 3 days later the reaction is resolving.									Y	01/12/2001	01/12/2001	0		PVT	PVT	Glucophage, NPH, Lipitor, Estrace, Zestoretic, Phentermine, Relafen, Lopid, Nasonex	allergic rhinitis	IDDM, allergy to quinine, Macrobid, niacin,			1						1	Injection site erythema; Injection site oedema; Pruritus	FLU3~PFIZER\WYETH~4008195~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165331	01/30/2001	LA	44.0	44		M	01/11/2001	Approximately 6 hour post vax, the pt felt feverish, had a fever of 102, left arm was sore tot he touch. The next evening (1/10/01) the pt noticed a 3 inch whelp on the left arm. Treated with Tylenol. Fever abated after 36 hours.									Y	01/09/2001	01/09/2001	0		PUB	PUB	Asacol	fatigue, arthritic feelings	hx of ulcerative colitis		LA010103	1						1	Injection site pain; Pyrexia; Urticaria	FLU3~PFIZER\WYETH~4008198~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~469133~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0165332	01/30/2001	IN	50.0	50		F	01/22/2001	One day post vax, the pt began to have pain in all joints. The pt continues to have problems with right knee and left ankle. The pt cannot stand or walk for any length of time. There is pain and swelling most of the time in both.									N	12/11/2000				OTH	PVT	Lotrel	slight head cold				1						1	Arthralgia; Difficulty in walking; Joint swelling	FLU3~PFIZER\WYETH~4008187~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165333	01/30/2001	PA	47.0	47		F	01/22/2001	45 minutes post vax, the pt experienced itching on arm. 1 hour post vax, the pt experienced whole body itching, red flushing. Treated with Benadryl. 4 hours later was repeated because of symptoms.									Y	12/22/2000	12/22/2000	0		PVT	UNK	Ortho Novum birth control pills	NONE	NONE			1						1	Erythema; Flushing; Pruritus	FLU3~PFIZER\WYETH~4008204~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165334	01/30/2001	NV	81.0	81		F	01/23/2001	The pt experienced a headache, fever of 101.9 for 15-20 hours. Fever began 24 hours post vax. The pt took Advil for the fever. The pt also experienced muscular aches. 3 days post vax, the pt experienced diarrhea, queeziness, nasal discharge and a cough for 2 weeks									Y	12/29/2000	12/29/2000	0		PUB	UNK	Premarin, Lipitor	NONE	NONE			1						1	Cough; Diarrhoea; Headache; Myalgia; Nausea; Pyrexia; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0165389	01/30/2001	NC	73.0			M	12/27/2000	A male, now 75 years old, reported that he received an influenza virus vaccine a couple of years ago and reportedly could not use his arms shortly afterwards. He could no lift them above his head and he reported that a virus entered my body when I received the flu shot.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ2954230OCT2000	1						1	Asthenia; Viral infection	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165390	01/30/2001	DE	53.0			F	12/22/2000	A female adult reported that she received '98-'99 formula influenza virus and Pneumovax 23 vaccines in 1998 and subsequently, developed a rash on her lower extremities. She was treated with diphenhydramine. She recovered.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ2588221OCT2000	1						1	Rash	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0165392	01/30/2001	NY	47.0			F	12/27/2000	A 47 year old female consumer reported that she received an influenza vaccine on 9/26/00. On 10/4/00, she experienced sneezing and nasal congestion.									U	09/26/2000	10/04/2000	8	UNK	OTH	OTH	Prempro, Humulin Insulin	UNK	Diabetes Mellitus NOS; Hormone replacement therapy		HQ2076111OCT2000	1						1	Nasal congestion; Sneezing	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165393	01/30/2001	MO				U	12/15/2000	A nurse reported approx. 12 pts from a single institution who received injections of Flu-Shield ('00-'01) on 11/6/00 and 11/07/00 developed injection site reactions characterized by redness, swelling and spots within a 2 diameter of injection. The reactions abated after 24 hours. The reporter indicated that approx. 12 pts experienced these events; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. Follow up information received 01/25/2001 from the original reported revealed all the patients recovered within 48 hours of the events. No patient specific information was provided.									Y	11/06/2000	11/06/2000	0	UNK	OTH	OTH	UNK	UNK	UNK		HQ3438209NOV2000	1						1	Injection site erythema; Injection site swelling; Rash maculo-papular	FLU3~PFIZER\WYETH~4008171~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165394	01/30/2001	NC				U	12/21/2000	A nurse reported that a pt received an injection of Flu Shield '00-'01 on 11/14/00 and subsequently developed an injection site reaction characterized by burning, severe pain, swelling, and redness. No further information was available at the date of this report. The reporter indicated that a total of 5 pts from this facility experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.									U	11/14/2000			UNK	OTH	OTH	UNK	UNK	UNK		HQ3851017NOV2000	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~PFIZER\WYETH~4008176~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165395	01/30/2001	MD				F	12/21/2000	A nurse reported a female pt received an injection of influenza virus vaccine on an unspecified date. Subsequent to vaccination, the pt developed a terrible cold with a tight, sore throat and an injection site reaction characterized by redness and pain.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ4080227NOV2000	1						1	Injection site erythema; Injection site pain; Nasopharyngitis; Pharyngolaryngeal pain; Throat tightness	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165396	01/30/2001	TX	39.0	39		F	12/21/2000	An MA reported that a 39 year old female received an injection of Flu Shield '00-'01 on 11/17/00 and subsequently, developed pain down her right side that extends to her toes. She is also having trouble walking.									U	11/17/2000	11/17/2000	0	UNK	OTH	OTH	UNK	UNK	UNK		HQ4082427NOV2000	1						1	Difficulty in walking; Pain	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165397	01/30/2001	VA				M	12/21/2000	On 11/22/00 the results of the tuberculin test were reportedly positive following the receipt of flu shield.									U	11/17/2000	11/22/2000	5	UNK	PVT	PVT	tuberculin - PPD	NONE	UNK		HQ4096227NOV2000	1						1	Laboratory test abnormal	FLU3~PFIZER\WYETH~4008183~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165398	01/30/2001	NC	42.0	42		M	12/21/2000	A nurse reported that a 42 year old male received an injection of Flu Shield '00-'01 on 11/18/00 and subsequently, developed a fever, hoarseness and a sore throat. On 11/22/00, she was seen by the physician. Follow up information received from the physician on 01/05/2001 indicated the patient recovered.				Y					Y	11/18/2000			UNK	PVT	PVT	Lipitor, Prevacid, vitamin E	NONE	Oesophageal reflux with history of induced laryngitis		HQ4100327NOV2000	1						1	Dysphonia; Pharyngolaryngeal pain; Pyrexia	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0165399	01/30/2001	CT	53.0	53		F	12/27/2000	A 53 year old female reported that she received an injection of Flu Shield '00-'01 on 10/26/00. Ten days, post vax, she developed an injection site reaction characterized by an indentation, pain, and tingling that radiated down her arm. She also developed neck pain. She was treated with gabapentin and celecoxib. As of 11/27/00, the symptoms persisted. Follow up information was received from an infectious disease specialist on 03/28/2001 who indicated that the patient was diagnosed with fat necrosis at the injection site.									U	10/26/2000	11/05/2000	10	UNK	PVT	OTH	Actonel, Premarin	NONE	UNK		HQ4177028NOV2000	1						1	Injection site pain; Injection site reaction; Neck pain; Necrosis; Paraesthesia	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165400	01/30/2001	NJ				M	12/22/2000	A pharmacist reported that a male received an injection of Flu Shield '00-'01 in 11/00 and subsequently, has experienced irritation of his eyes when using contact lens solution containing thimerosal. The reporter indicated that the pt had no previous history of sensitivity to thimerosal. No further information was available at the date of this report.									U	11/01/2000			UNK	OTH	OTH	UNK	UNK	UNK		HQ4338301DEC2000	1						1	Unevaluable event	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165401	01/30/2001	FL	67.0	67		F	12/22/2000	A 67 year old female reported that she received an injection of Flu Shield '00-'01 on 11/30/00 and subsequently experienced an increase in pain.									U	11/30/2000	11/30/2000	0	UNK	PVT	PVT	UNK	NONE	Atrioventricular block NOS; back pain; carpal tunnel syndrome; injury NOS; limb injury NOS; Spinal disorder NOS; valvular heart disease NOS; diabetes mellitus with peripheral neuropathy NEC		HQ4516406DEC2000	1						1	Pain	FLU3~PFIZER\WYETH~4008185~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165402	01/30/2001	NY	54.0			M	12/21/2000	A 54 year old male reported that he received an injection of Flu Shield '00-'01 on 11/30/00. On 12/1/00, he developed redness and itching over his entire body. He also developed dime-sized hives at he injection site. He was treated with methylprednisolone. The hives resolved. As of 12/4/00, the redness and itching persisted. Follow up information received from the physician on 01/05/2001 indicated that the patient recovered.									Y		12/01/2000		UNK	OTH	PUB	Ocupress	NONE	UNK		HQ4522206DEC2000	1						1	Erythema; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4008180~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165403	01/30/2001	NC	22.0	22		F	12/21/2000	A nurse reported that a 22 year old pregnant female inadvertently received an intradermal injection of Flu Shield '00-'01 instead of a tuberculin test on 11/30/00. That day, she developed an injection site reaction characterized by redness and a bruise. Follow up from the physician received 02/06/2001 indicated that the injection site reaction resolved.									Y	11/30/2000	11/30/2000	0	UNK	PVT	PUB	NONE	NONE	Pregnancy NOS (Serum)		HQ4540306DEC2000	1						1	Ecchymosis; Injection site erythema	FLU3~PFIZER\WYETH~4008179~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165404	01/30/2001	KY	49.0	49		M	12/27/2000	A healthcare professional reported that a 49 year old male received an injection of Flu Shield '00-'01 on 11/27/00 and subsequently experienced tingling in his legs and nausea. This is 1 of 2 pts from this facility who experienced this event, post vax, lot #4008185.									U	11/27/2000			UNK	PVT	PVT	UNK	NONE	UNK		HQ4632308DEC2000	1						1	Nausea; Paraesthesia	FLU3~PFIZER\WYETH~4008185~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165405	01/30/2001	NC				U	12/21/2000	A nurse reported that a pt received an injection of Flu Shield '00-'01 on 11/15/00 and subsequently developed an injection site reaction characterized by burning, severe pain, swelling and redness. This is 1 of 5 pts from this office who experienced an adverse event with Flu Shield. No further information was available at the date of this report.									U	11/15/2000			UNK	OTH	OTH	UNK	UNK	UNK		HQ4690411DEC2000	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~PFIZER\WYETH~4008186~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165406	01/30/2001	NC				U	12/22/2000	A nurse reported that a pt received an injection of Flu Shield '00-'01 on 11/16/00 and subsequently developed an injection site reaction characterized by burning, severe pain, redness and swelling. This is 1 of 5 pts from this office who experienced an adverse event with the administrating of Flu Shield. No further information was available at the date of this report.									U	11/16/2000	11/16/2000	0	UNK	OTH	OTH	UNK	UNK	UNK		HQ4690511DEC2000	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~PFIZER\WYETH~4008176~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165407	01/30/2001	CA	61.0	61		F	12/21/2000	A healthcare professional reported that a 61 year old female received an injection of Flu Shield '00-'01 on 12/06/00. Within 24 hours, the pt developed a rash with hives on her forearms, neck, and trunk, pruritus and wheezing. The pt was treated with epinephrine and Benadryl but the rash worsened. The reporter noted that Flovent therapy may also be the cause of the events.									U	12/06/2000	12/07/2000	1	UNK	PVT	OTH	Diovan, Flovent	UNK	Asthma NOS		HQ4706111DEC2000	1						1	Pruritus; Urticaria; Wheezing	FLU3~PFIZER\WYETH~4008191~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165408	01/30/2001	NC	32.0	32		F	12/22/2000	A nurse reported that a 32 year old female received Flu Shield '00-'01 on 12/4/00. On 12/5/00, she developed a red and swollen arm and was seen by her rheumatologist. A dx of infection at the injection site was made. The pt was prescribed an antibiotic.									U	12/04/2000	12/05/2000	1	UNK	PVT	PVT	Celebrex, Oxycontin, Norontin	NONE	UNK		HQ4706511DEC2000	1						1	Injection site erythema; Injection site swelling	FLU3~PFIZER\WYETH~4008188~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165409	01/30/2001	NC				U	12/29/2000	A nurse reported that a pt received an injection of Flu Shield '00-'01 on 12/4/00 and the next day, the pt developed an injection site reaction characterized by redness, soreness, swelling and itching. The reaction was managed with an unspecified antibiotic.									U	12/04/2000	12/05/2000	1	UNK	OTH	OTH	Celebrex, Neurontin, Oxycontin	UNK	UNK		HQ4760112DEC2000	1						1	Injection site erythema; Injection site pain; Injection site swelling; Pruritus	FLU3~PFIZER\WYETH~4008188~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165410	01/30/2001	NY				U	12/27/2000	A physician reported that a pt received an injection of Flu Shield '00-'01 and subsequently developed hypoglycemia. The reporter indicated that he did not believe that the pt's experience of hypoglycemia was caused by Flu Shield. Follow up states patient recovered.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ4802313DEC2000	1						1	Hypoglycaemia	FLU3~PFIZER\WYETH~4008197~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165411	01/30/2001	CA	78.0	78		F	12/22/2000	A 78 year old female reported she received an injection of '00-'01 of influenza virus vaccine on 11/7/00. Subsequently, she experienced dizziness, headache, insomnia and bone aches. The caller stated that her physician found no evidence of infection.									U	11/07/2000			UNK	OTH	OTH	Prednisone	UNK	UNK		HQ4874414DEC2000	1						1	Bone pain; Dizziness; Headache; Insomnia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165412	01/30/2001	CO				U	12/22/2000	A nurse practitioner reported that a pt received an injection of Flu Shield '00-'01. Following the immunization, the pt's INR (international normalized ratio) was increased. No further information was available at the date of this report. The reporter indicated that 2 or 3 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.									U				INR-increased	OTH	OTH	UNK	UNK	UNK		HQ4890414DEC2000	1						1	Prothrombin time prolonged	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165413	01/30/2001	IN	20.0	20		F	12/27/2000	A nurse reported that a 20 year old female with a history of asthma received an injection of Flu Shield '00-'01 on 12/12/00. On the morning of 12/13/00, she experienced numbness and tingling in her left arm and left leg. The reporter indicated the physician treated the reaction as an allergic reaction. She recovered.									Y	12/12/2000	12/13/2000	1	UNK	OTH	PUB	Proventil	NONE	Asthma NOS		HQ4900115DEC2000	1						1	Hypersensitivity; Paraesthesia	FLU3~PFIZER\WYETH~4008201~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165414	01/30/2001	VA				M	12/22/2000	A nurse reported that a male received injections of Flu Shield '00-'01 and tuberculin, PPD on 11/20/00. On 11/22/00, the results of the pt's tuberculin test were reportedly positive. This is 1 of 2 pts from this facility who developed a positive tuberculin test following receipt of Flu Shield lot 4008183.									U	11/20/2000			Tuberculin-positive	PVT	PVT	Tuberculin, PPD-positive	NONE	UNK		HQ5124420DEC2000	1						1	Laboratory test abnormal	FLU3~PFIZER\WYETH~4008183~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165415	01/30/2001	VA				F	12/27/2000	A nurse reported that a female received an injection of Flu Shield '00-'01 and within 24 hour, she developed mastitis in her right breast. She was treated with antibiotics. She recovered. No further information was available at the date of this report.									Y				UNK	PUB	OTH	UNK	UNK	UNK		HQ5158221DEC2000	1						1	Mastitis	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165416	01/30/2001	NV	34.0	34		F	12/27/2000	A nurse reported that a 34 year old female received an injection of Flu Shield '00-'01 on 11/23/00 and subsequently, developed neck and shoulder pain. She recovered after 2 weeks. This is 1 of 2 pts from this facility who had an adverse experience, post vax, Flu Shield.									Y	11/23/2000			UNK	OTH	OTH	UNK	UNK	UNK		HQ5178221DEC2000	1						1	Neck pain; Pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165417	01/30/2001	KY	52.0	52		F	12/27/2000	A healthcare professional reported that a 52 year old female received an injection of Flu Shield '00-'01 on 11/29/00 and subsequently, experienced tingling in her legs and nausea. This is 1 of 2 pts from this facility who experienced this event following receipt of Flu Shield lot 4008185.									U	11/29/2000			UNK	PVT	PVT	UNK	NONE	UNK		HQ5229422DEC2000	1						1	Nausea; Paraesthesia	FLU3~PFIZER\WYETH~4008185~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165418	01/30/2001	NV				F	12/27/2000	A nurse reported that a female pt received Flu Shield '00-'01 and Pneumovax 23 (MSD) vaccines on 11/13/00 and subsequently, developed neck and shoulder pain. She recovered after 2 weeks. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Flu Shield.									Y	11/13/2000			UNK	PVT	OTH	UNK	UNK	UNK		HQ5244727DEC2000	1						1	Neck pain; Pain; Neck pain; Shoulder pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1|FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0165419	01/30/2001	IN	45.0			M	04/04/2001	The wife of a 45 year old male reported that her husband received an injection of influenza virus vaccine. The next day, he experienced numbness and tingling of his feet extending into the pelvic area. The pt was seen by a physician who sent him to an ER. The pt was also seen by a neurologist.				Y					U				Unspecified blood tests, an MRI, X-rays and nerve conduction tests were performed; however, result were not provided.	OTH	OTH	UNK	UNK	UNK		HQ5408129DEC2000	1						1	Paraesthesia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0165420	01/30/2001	PA	33.0	33		F	01/17/2001	A nurse reported that a 33 year old female received an injection of Flu Shield '00-'01 on 11/15/00. Immediately, post vax, she developed a painful knot in her neck. She was treated with ibuprofen and it resolved after 3 hours. Later that day, she developed a swollen tongue and numb lips that felt like pins and needles. She felt strange and became pale. She was treated with oral diphenhydramine. She recovered on 11/16/00. This is 1 of 3 pts from this facility who had an adverse experience following receipt of Flu Shield '00-'01, lot 4008176.									Y	11/15/2000	11/15/2000	0	UNK	PVT	PVT	NONE	NONE	UNK		HQ5928515JAN2001	1						1	Feeling abnormal; Hypoaesthesia oral; Lymphadenopathy; Pallor; Tongue oedema	FLU3~PFIZER\WYETH~4008176~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165421	01/30/2001	VA	47.0	47		F	12/27/2000	A 47 year old female received an injection of Flu Shield '00-'01 on 10/30/00. On 10/31/00, she reportedly developed swelling at the injection site.									U	10/30/2000	10/31/2000	1	UNK	PVT	OTH	Atenolol, lorazepam, ranitidine, Zoloft	NONE	UNK		HQ3202503NOV2000	1						1	Injection site swelling	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165422	01/30/2001	CA				F	12/21/2000	A female reported that she received an injection of Flu Shield '00-'01 on 10/25/00 and subsequently developed redness at the injection site. As of 11/9/00, the redness persisted. No further information was available at the date of this report.									U	10/25/2000			UNK	OTH	OTH	UNK	UNK	UNK		HQ3506710NOV2000	1						1	Injection site erythema	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165423	01/30/2001	PA	42.0	42		F	12/21/2000	A nurse reported that a pt received an injection of Flu Shield '00-'01 on 11/15/00 and subsequently developed an injection site reaction. No further information was available at the date of this report. The reporter indicated that 3 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. Follow up states additional information received on 01/10/2001 indicated that the patient is a 42-year-old female who developed redness, swelling, and warmth at the injection site. The patient recovered after 3 to 4 days.									Y	11/15/2000			UNK	PVT	PVT	UNK	UNK	UNK		HQ3872617NOV2000	1						1	Feeling hot; Injection site erythema; Injection site reaction; Injection site swelling	FLU3~PFIZER\WYETH~4008176~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165424	01/30/2001	WA				U	12/22/2000	A nurse reported that a pt received an injection of Flu Shield '00-'01 on 11/15/00 and subsequently developed an injection site reaction. No further information was available at the date of this report. The reporter indicated that 5 pts  experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.									U	11/15/2000			UNK	UNK	UNK					HQ3874717NOV2000	1						1	Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165425	01/30/2001	IN				U	12/21/2000	A nurse reported that a pt received an injection of Flu Shield on 11/16/2000 and subsequently developed an injection site reaction characterized by a reddened area.									U	11/16/2000			UNK	PVT	PVT	UNK	UNK	UNK		HQ4089327NOV2000	1						1	Injection site erythema	FLU3~PFIZER\WYETH~4008179~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165426	01/30/2001	IA	33.0	33		M	12/21/2000	A pharmacist reported that a 33 year old male pt received Flu Shield '00-'01 and Pneumovax on 11/28/00. On that same date, the pt developed an injection site reaction characterized by a hard knot. The event has since resolved.									Y	11/28/2000	11/28/2000	0	UNK	PVT	OTH	CellCept, Neoral, Norvasc, Pepcid, Prednisone, Toprol XL	UNK	Renal transplant		HQ4284430NOV2000	1						1	Injection site mass	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~~UNK~SC~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0165427	01/30/2001	OH	39.0			F	12/21/2000	A nurse reported that a 39 year old female received an injection of Flu Shield '00-'01 on 11/16/00. On 11/28/00, she developed soreness at the injection site and pain in her arm with movement. Follow up information received on 01/03/2001 indicated the patient recovered.									Y		11/28/2000		UNK	PUB	OTH	UNK	UNK	UNK		HQ4332201DEC2000	1						1	Hypokinesia; Injection site pain	FLU3~PFIZER\WYETH~4008174~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165428	01/30/2001	NC				U	12/21/2000	A pharmacist reported that a pt received an injection of Flu Shield '00-'01 on 12/2/00 and 2 days later, the pt developed an injection site reaction characterized by a knot at the injection site.									U	12/02/2000	12/04/2000	2	UNK	OTH	OTH	UNK	UNK	UNK		HQ4518606DEC2000	1						1	Injection site mass	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165429	01/30/2001	IN				U	12/21/2000	A nurse reported a pt received an injection of Flu Shield '00-'01 on 11/16/00 and subsequently developed an injection site reaction characterized by a hard knot.									U	11/16/2000			UNK	PVT	PVT	UNK	UNK	UNK		HQ4966218DEC2000	1						1	Injection site mass	FLU3~PFIZER\WYETH~4008179~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165430	01/30/2001	IN				F	12/21/2000	A nurse reported a female pt received an injection of Flu Shield '00-'01 on 11/16/00 and subsequently developed an injection site reaction characterized by swelling. The pt also developed a pin-point rash on her chest. The pt felt the reaction was due to  the bandaid as she said it went away when she took the bandaid off.									Y	11/16/2000			UNK	PVT	PVT	UNK	UNK	UNK		HQ4966318DEC2000	1						1	Injection site swelling; Rash	FLU3~PFIZER\WYETH~4008179~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165431	01/30/2001	IL	11.0	11		M	12/21/2000	A nurse reported that an 11 year old male received an injection of Flu Shield '00-'01 on 12/15/00. That same day, the pt developed an injection site reaction characterized by pain and hives. Within 48 hours, the hives spread over his entire body. The child was treated with Benadryl and prednisone and the child seemed to be getting better. Follow up states hives resolved in one week. No residual problems at this time.									U	12/15/2000	12/15/2000	0	UNK	PVT	OTH	Adderall, albuterol	UNK	Asthma NOS; Drug hypersensitivity (environmental and codeine allergy)		HQ5096120DEC2000	1						1	Injection site pain; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165432	01/30/2001					M	12/28/2000	A consumer reported that he received an injection of Flu Shield '00-'01 on 12/14/00 and subsequently developed pain in the shoulder area of his left arm and can not raise his arm.									U	12/14/2000			UNK	OTH	OTH	UNK	UNK	UNK		HQ5274927DEC2000	1						1	Hypokinesia; Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165433	01/30/2001	PA	56.0	56		F		A nurse reported that a 56 year old female received an injection of Flu Shield '00-'01 on 11/15/00 and subsequently developed an injection site reaction characterized by redness, swelling and warmth. She recovered after 2 weeks. This is 1 of 3 pts from this facility who had an adverse experience following receipt of Flu Shield '00-'01, lot 4008176.									Y	11/15/2000			UNK	PVT	PVT	Propylthiouracil	NONE	Drug hypersensitivity		HQ5928415JAN2001	1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~PFIZER\WYETH~4008176~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163170	01/31/2001	NJ	54.0	54		F	01/23/2001	My arm hurt, then I felt like someone had punched me very hard in the chest. Then pain traveled up to my neck, jaw, teeth, eye and to the top of my head. Which I was in very bad pain all day. Then it hit my sinus and chest and I was very sick. I was ill for 3 weeks, very bad.									Y	11/18/2000	11/18/2000	0		PUB	PVT						1						2	Chest pain; Eye pain; Headache; Injection site pain; Malaise; Neck pain; Pain in jaw	FLUX~UNKNOWN MANUFACTURER~2605~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0164835	01/31/2001	MI	37.0	37		F	01/05/2001	The pt was given the flu vaccine and within 15 minutes experienced a rash, tightening of the throat, wheezing and difficulty breathing. The pt was treated with epinephrine and Benadryl. 911 was called for transport to the hospital. After receiving medications her breathing improved. The pt was reported as having an anaphylactic reaction.					Y				U	12/12/2000	12/12/2000	0		UNK	UNK			hx of asthma, not on medication, uses inhaler on occasion (seasonal)			1						3	Anaphylactic reaction; Dyspnoea; Rash; Throat tightness; Wheezing; Anaphylactic reaction; Dyspnoea; Rash; Wheezing; Anaphylactic reaction; Dyspnoea; Rash; Throat tightness; Wheezing	FLU3~PFIZER\WYETH~4008181~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4008181~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|FLU3~PFIZER\WYETH~4008181~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~3	USA	Hospitalisation	Influenza
0165434	01/31/2001	CO	59.0	59		F	12/20/2000	The same day of the vax, the pt developed hives. She was treated with antihistamines. The next day she experienced difficulty swallowing and a drop in her diastolic BP to 60. The pt was admitted to the hospital and treated with prednisone and epinephrine. As of 11/27/00 the pt had been discharged from the hospital. Follow-up information received 12/18/00 indicated that the pt was seen in the ER and then hospitalized for 5 days. Follow-up information also included the state and county of the vaccine administration and the correct phone number of the reporter.				Y	Y	5			U	11/18/2000	11/19/2000	1	UNK	PVT	OTH	Zantac, Acyclovir, Premarin	UNK	UNK		HQ4156228NOV2000	1						1	Dysphagia; Hypotension; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0165468	01/31/2001	MD	66.0	66		M		26-28 hours, post vax, had extreme diarrhea that lasted 5 days, off and on. 28-30 hours, post vax, had vomiting which returned after any solid food eaten, for 5 days. Then I got a 2 week head cold.									Y	12/13/2000	12/14/2000	1		PVT	PVT		NONE				1						1	Diarrhoea; Nasopharyngitis; Vomiting	FLU3~PFIZER\WYETH~4008187~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165469	01/31/2001	GA	36.0	36		F	01/23/2001	On 11/27/00, received vaccine in left deltoid and since that time, has had pain in arm radiating into fingers. Complained of joint pain especially at night and difficulty in lifting and opening jars.				Y					N	11/27/2000	11/29/2000	2	NONE	PVT	PVT	Reglan	NONE	GERD			1						1	Arthralgia; Asthenia; Pain; Hypokinesia; Pain; Shoulder pain	FLU3~AVENTIS PASTEUR~U04355AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~AVENTIS PASTEUR~U04355AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0165470	01/31/2001	MA	77.0			F	01/18/2001	On 12/11/00, at 14:00, pain started in shoulder of arm and went down to wrist. As of 1/10/00, pain continues. Saw MD X 2, orthopedist X 1 and received cortisone shot on 1/10/01, with good relief.									Y	12/11/2000	12/11/2000	0		PUB	PUB	UNK	NONE	Allergic to strawberries; has had a cardiac bypass.			1						1	Injection site pain; Pain	FLU3~AVENTIS PASTEUR~U0443AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0165471	01/31/2001	KY	38.0	38		F	01/19/2001	Pt developed an area of redness at the site of injection. The area was 6.25cm X 5cm. There was no itching or swelling but the area was warm to the touch.									Y	11/20/2000	11/20/2000	0		MIL	MIL	Deconamine, Nasonex, Allegra, nortriptyline, Neurontin, Gaviscon		Allergy to Erythromycin			1						1	Injection site erythema; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~1~SC~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0165472	01/31/2001	KY	53.0	53		M	01/19/2001	Following vaccination, pt developed an area of redness (15cm X 10cm) which was warm to the touch. No induration was noted. The pt noted tingling in the fingers for a 24 hour period. 11/28/00									Y	11/28/2000	11/28/2000	0		MIL	MIL						1						1	Erythema; Feeling hot; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~1~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0165473	01/31/2001	KY	42.0	42		F	01/19/2001	Post vax, on 11/28/00, the pt quickly developed a 6cm X 2cm area of redness, without induration. The are was warm to the touch but subsided quickly.									Y	11/28/2000	11/28/2000	0		MIL	MIL						1						1	Injection site erythema; Injection site warmth	FLU3~PFIZER\WYETH~400329~UNK~SC~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165474	01/31/2001	KY	43.0	43		F	01/19/2001	Five minutes, post vax, the pt reported light-headedness. She was instructed to take deep breaths and elevate feet. A physician was notified and came to review the situation. She later reported numbness in both arms, nausea and increased pressure in the back of her head, neck and lower skull. In a matter of minutes, pt progressed to a state of semi-consciousness. Pt was transported to the ER.				Y					Y	11/21/2000	11/21/2000	0		MIL	MIL			Allergy to gold sodium thiosalicylate			1						1	Depressed level of consciousness; Dizziness; Headache; Hypoaesthesia; Nausea; Neck pain	FLU3~PFIZER\WYETH~4003209~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0165475	01/31/2001	KY	53.0	53		F	01/19/2001	Within 36 hours, post vax, pt developed localized swelling at the injection site. No itching, soreness or induration noted.									Y	11/28/2000	11/28/2000	0		MIL	MIL	Celebrex, Lotensin, Estrogen					1						1	Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~1~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0165476	01/31/2001	SD	39.0	39		F	01/23/2001	Post vax, right deltoid became red, itchy and with 50 cent-sized induration. PO Benadryl taken. Thirty minutes later, throat feels swollen and harder to swallow. Escorted to ER in hospital (next door) and they were too busy to see her for 1/2 hour. She worked at the clinic. Symptoms subsided with no reoccurrence.				Y					Y	12/07/2000	12/08/2000	1	NONE	PVT	PVT	Synthroid, BCP	NONE	NONE			1						1	Dysphagia; Injection site erythema; Injection site induration; Pharyngeal oedema; Pruritus	FLU3~PFIZER\WYETH~U0985011~7+~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0165477	01/31/2001	TX	87.0	87		F	01/23/2001	Area below right deltoid became very red, warm to touch and edematous. This lasted X 2 days. Onset was 1 day, post vax.									N	01/03/2001	01/04/2001	1	NONE	OTH	PUB	Neurontin, Aricept, Coumadin, Altace, Prilosec, Effexor		Allergies to Cipro, Cortizone, PCN			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~PFIZER\WYETH~4008173~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165478	01/31/2001	PA	83.0	84		F	01/24/2001	Sudden onset of right facial paralysis on 1/8/01. Seen in ER and Rx'd prednisone, Lacrilube and Natural tears. Symptoms and facial droop are improving but not resolved at this time. Dx'd with Bell's Palsy.				Y					N	12/27/2000	01/08/2001	12	CBC; BUN; CR; Glucose-all nml; CT of brain-no stroke; Carotid US-no significant stenosis	PVT	PVT	Toprol XL, ASA, Calcium, Norvasc, multivitamins	NONE	Allergy to PCN, hypertrophic cardiomyopathy, hypertension, coronary artery disease			1						1	Facial palsy	FLU3~PFIZER\WYETH~4008221~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0165479	01/31/2001	WI	50.0	48		F	01/24/2001	On 12/29/00, had dry throat, hives on right wrist, inside of knees, buttocks and hips. On 12/30/00 and 12/31/00, had sore throat and dry cough.									Y	12/26/2000	12/29/2000	3		PVT	UNK		NONE	NONE			1						1	Cough; Pharyngolaryngeal pain; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0165480	01/31/2001	TX	68.0	68		F		Rash-like heat rash appeared around waist and spread to legs, feet and to arms last. Did not get on my face, neck, chest or bottoms of feet or scalp. Under doctor's care since onset. Treated with 2 shots, pills and cream (methylprednisolone and triamcinolone). The 2 doctors who have treated me, don't know the cause of this rash which is almost gone except for a small patch on my leg and fading spots on top of my feet. Since I had called about this and it was in the time frame of the flu shot, I completed the form.									Y	11/16/2000	11/21/2000	5	2 Blood tests-neg	PUB	UNK						1						1	Rash	FLUX~UNKNOWN MANUFACTURER~G0008~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0165497	02/01/2001	TX	23.0	23		F	01/23/2001	The mother states patient had a headache and had been vomiting and collapsed.Mom found her unrepsonsive. Went to ER found blood in head. Went by care flight and 2nd hospital for surgery attempted; didn't wake, worse bleeding from abnormal plexus of veins in cerebellum patient expired. Death certificate states cause of death to be cerebral herniation due to rupture of cerebellar arteriovenous malformation.	Y	11/26/2000							N	11/21/2000	11/26/2000	5	NONE	PVT	PVT	Celexa	depression, stress reaction	seasonal allergies, stress reaction, depression			1						1	Cerebral haemorrhage; Cerebrovascular disorder; Delirium; Headache; Vein disorder	FLU3~AVENTIS PASTEUR~40428AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0165507	02/01/2001	LA	70.0	70		F	01/24/2001	This patient's family indicates that she is now being transferred to the rehabilitation unit to continue her recovery from her neurological illness. The patient was originally transferred to medical Center on 01/01/01. The patient's symptoms actually began on 12/26/00 when she began a syndrome of nausea, emesis, and a productive cough. The patient deteriorated until 12/31/00 when her husband noticed that she was very disoriented, that she was unable to sit up, she was unable to transfer without the patient's help. Because of this and the continuing complaint of headache the patient was seen at another Hosp where she was admitted. The patient was initially given Rocephin and a lab work up was done. The patient's admitting physician noted her to be stuporous, but responsive until the night time hours when she gradually became less responsive. It was also noticed by the Physician that she was having difficulty with movement of her right eye, the right eye coming to the midline. The patient was also having a tendency to keep her head deviated to the left side, though she was moving her arms and legs. With this history she was transferred to Medical Center. Her initial physical examination revealed her to be mildly febrile, temp of 100F, with snoring respiration's and upper airway noise. She would open her eyes with pain stimulation and when deep suctions, though her eyes would not attempt to follow any commands. Her oral airway mildly compromised with oral secretions. Her neurologic exam revealed her to be unresponsive but would open her eyes briefly with pain and with strong verbal stimulation. The patient's moved both arms and legs after passive range of motion. The patient's reflexes were one to two plus and symmetrical. Plantar stimulation was flexor on the right, questionably up going on the left. It was felt that the sixth nerve palsy was a false localizing sign and so the patient under went diagnostic studies. Ct scan of the brain and an MRI of the brain was done. The MRI showed areas of abnormality in the floor of the fourth ventricle at the pontomedullary junction. Lumbar puncture was done, routine diagnostic studies showed an elevated spinal fluid protein, but more impressively showed marked elevated fluid IGG synthesis. The patient developed respiratory distress and had to be intubated to protect her airway. She was treated with antibiotics in addition to the Rocephin. Over the next several days the patient was maintained on a ventilator, then she became more arousable was able to be extubated; the released from intensive care. The patient was moved to a regular room more alert but at times confused and disoriented. The patient has finally become aware of diplopia as the right sixth cranial nerve palsy has persisted. The neuro team has been seeing the patient and has noted she is unable to sit , stand or transfer unsupported.  All medication were discontinued as felt necessary as the patients spinal fluid cell count was 0. Further  history from the patient has indicated that she had a Flu vaccine two weeks before the onset of these symptoms. The patient has been referred for a comprehensive rehabilitation program; length of stay two weeks.			Y		Y				Y	11/27/2000	12/26/2000	29	CT scan of brain, MRI of brain - abnormal, lumbar puncture - elevated spinal synthesis, bronchoscope,	PVT	PVT	Celebrex , Prinivil, Aspirin, Tenormin, Estratab.                                              Medications on Transfer: Lopressor, Lanoxin, Zestril, Dilantin, Zantac.	NONE	NONE			1						1	Coma; Cough; Delirium; Diplopia; Disorientation; Eye disorder; Eye pain; Headache; Laboratory test abnormal; Mental impairment; Movement disorder; Nausea; Nervous system disorder; Pyrexia; Respiratory distress; Stupor; Torticollis; Vomiting	FLU3~PFIZER\WYETH~400817~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0165512	02/01/2001	IL	41.0	41		F	01/04/2001	This patient complained of flu like symptoms, ie : chills, mild diarrhea, GI discomfort, back and spinal pain, severe dizziness (spinning room) for almost 12 hours, no fever. The symptoms started 3 days after her injection and lasted about 4 days. No treatment was given.									Y	12/27/2000	12/30/2000	3	NONE	OTH	OTH		NONE	Allergic to Penicillin, Bactrim, Fluoroguinolunes			1						1	Back pain; Chills; Diarrhoea; Dizziness; Gastrointestinal pain; Influenza like illness	FLU3~PFIZER\WYETH~4008221~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165513	02/01/2001	FL	52.0	52		F	01/30/2001	This patient had bilateral pedal edema.				Y					Y	12/07/2000	12/07/2000	0		OTH	OTH	Insulin, ASA, Nonase, Primivil, Glucotrol XL, Metformin.		Type II diabetes mellitus, hypertension, asthma.			1						1	Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0165514	02/01/2001	GA	89.0	89		F	01/30/2001	This patient had flu like symptoms, splotches on legs, numbness in feet, weakness, and vasculitis.									N	10/02/2000	10/02/2000	0	ESR 66, Skin biopsy And Vasculitis.	OTH	PVT		NONE	NONE			1						1	Asthenia; Hypoaesthesia; Influenza like illness; Rash maculo-papular; Vasculitis; Asthenia; Fatigue; Feeling jittery; Hypersensitivity; Influenza like illness; Myalgia; Oedema peripheral; Pyrexia; Rash maculo-papular; Red blood cell sedimentation rate increased; Vasculitis	FLU3~PFIZER\WYETH~468148~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|PPV~MERCK & CO. INC.~U0449AA~UNK~~~PNEUMO (PNEUMOVAX)~1|IPV~UNKNOWN MANUFACTURER~~UNK~IM~~POLIO VIRUS, INACT. (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0165515	02/01/2001	OH	50.0	50		F	01/17/2001	This patient had a red swollen patch 1 wide by 2 across, heat and pain in area; shortness of breath, paleness. The physician stated 1 1/2  wide by 3 across, local not systemic.				Y					Y	01/15/2001	01/15/2001	0		OTH	PVT	Synthyroid, Cytomel	NONE	NONE			1						1	Dyspnoea; Erythema; Injection site pain; Injection site warmth; Pallor; Urticaria	FLU3~PFIZER\WYETH~4008219~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0165516	02/01/2001	MO	30.0	10		F	10/15/2000	The patient had shots, ten minutes later she had light headedness, heart beating fast, hard to breathe, feels like anxiety attack. The !st dose of epi given 0.3 cc symptoms began to subside. Symptoms still occurring after another 5 minutes. She was given 2nd dose of epinephrine sq symptoms: difficulty breathing continued, administered 3rd dose of epinephrine after another 7 minutes. Emergency staff began arriving about 5-10 minutes later. Administered oxygen and a breathing treatment, transported the patient to Independence Regional Hospital Emergency room. She was released that afternoon.				Y					Y	10/15/2000	10/15/2000	0	Most ambulance and Independence Regional would have this info.	OTH	PVT	Took Allegra in the AM	NONE	NONE			1						1	Anxiety; Dizziness; Dyspnoea; Heart rate irregular	FLU3~MEDEVA PHARMA, LTD.~E59260GA~3~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0165517	02/01/2001	CA	46.0	57		M	01/09/2001	This patient had a fever, body muscle aches, headache, general symptoms of the flu, mild to moderate.									Y	12/18/2000	12/19/2000	1		OTH	OTH		NONE	NONE			1						1	Headache; Influenza like illness; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0164125	02/02/2001	MA	81.0	81		M	11/17/2000	That evening, post vax, right deltoid was swollen and he said he felt feverish. Applied ice to right deltoid. On 11/17/00, at 06:30, arm swelling dispersed. Approx. 8 X 4, mild redness and swelling and soreness. Ice applied and took Tylenol previous night and morning. Swelling subsided by 11/20/00.									Y	11/16/2000	11/16/2000	0		PUB	PUB	Norvasc, Atenolol, aspirin	NONE	hypertensive heart disease, allergy to pork		MA0018	1						2	Feeling hot; Injection site erythema; Injection site pain; Injection site swelling	FLU3~AVENTIS PASTEUR~U0435AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1217J~2~SC~RA~PNEUMO (PNEUMOVAX)~2|TD~MASS. PUB HLTH BIOL LAB~TD70~UNK~IM~RA~TD ADSORBED (TDVAX)~2	USA		Influenza
0165263	02/02/2001	NC	51.0	51		F	01/24/2001	One day post vax, the pt developed flu-like symptoms and had pain on the right side of her chest. The pt noted that she then went to an ER facility where she was diagnosed with severe bacterial pneumonia that was confirmed by cultures She spend nine days in the hospital where she received unspecified IV antibiotics. Therapy was then switched to oral Keflex for 10 days once she was discharged from the hospital. On 1/15/01 the pt returned to the ER and was subsequently diagnosed with inflammation of the pleural cavity. She was discharged.					Y	9			N	12/20/2000	12/21/2000	1	UNK	PVT	PVT	Klonopin, Prempro, Serevent, Vioxx	NONE	Asthma NOS; Emphysema		HQ6270423JAN2001	1						2	Asthma; Bacterial infection; Chest pain; Influenza like illness; Laboratory test abnormal; Obstructive airways disorder; Pleurisy; Pneumonia; Bacterial infection; Chest pain; Influenza like illness; Pleurisy; Pneumonia	FLU3~PFIZER\WYETH~~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0165525	02/02/2001	AL	4.0	4		F	12/09/2000	The pt was found in bed at home without a pulse of respirations at 8:00 am on 12/9/00. She was given a glucogon injection and CPR was started and continued until EMS arrived. The pt was intubated and 2 doses of epinephrine and 1 dose of atropine were given during transport to the ER. The pupils were fixed and dilated. At the ER, the pt received epinephrine and atropine in the ER. The pt expired at 9:30 AM on 12/9/00 with cause of death being cardiopulmonary arrest. The pt had taken the normal dose of insulin on 12/8/00 with an accucheck of 147 at 10:20PM on 12/8/00. She had received the flu vaccine at 3:00PM on 12/8/00 in the physicians office. Death certificate states cause of death to be cardiopulmonary arrest. Autopsy report states: pulmonary vascular congestion and edema.	Y	12/09/2000							N	12/08/2000	12/09/2000	1		UNK	UNK	insulin in AM and PM		type I diabetes			1						1	Cardio-respiratory arrest; Mydriasis; Pulmonary congestion; Pulmonary oedema	FLU3~PFIZER\WYETH~4008187~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0165539	02/02/2001	OR	45.0	45		M	02/01/2001	On 12/2/00, this pt developed right parascapular pain and on 12/6/00 developed right hand weakness and dyscoordination. He has specific weakness of thumb and abduction of fingers with decreased pinch and grip strength. A c-spine MR was performed and did not explain symptoms. A MRI of his brain is pending. A tentative diagnosis has been made of brachial plexitis. F/U rec'd fromreporter 6/27/01 via telephone. the reporte ? that she rec'd f/u info consisting of the following. the pt has not fully recovered and has regained 70% of his strength in the R arm and shoulder and still experiences pain in the R arm  requiring daily use of motrin. The pt is seeing a neurologist. No other info was available, further inof requested from the reporter.									U	10/10/2000	12/02/2000	53		OTH	OTH	Lisinopril		hypertension		MPI2001000310	1						1	Asthenia; Coordination abnormal; Muscular weakness; Nervous system disorder; Pain	FLU3~MEDEVA PHARMA, LTD.~E67930KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0165540	02/02/2001	WI	27.0	27		M	01/26/2001	This patient has history of [[name]] Barre' Syndrome with residual symptoms of leg pain and leg spasms. His girlfriend read Influenza information sheet after he received the Flu shot and she became concerned that the patient's residual symptoms were worse after his flu shot. The patient denies that his symptoms are worse, he was evaluated by the doctor who ruled out [[name]] Barre Syndrome or exacerbation of residual symptoms of the syndrome. Hx of GBS as teenager, residual pain in leg- spasma also tendonitis of wrists.									U	12/21/2000			NONE	PUB	UNK		NONE	history of Guillain Barre' Syndrome 1989 - 1990			1						1	Unevaluable event	FLU3~PFIZER\WYETH~4008224~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165541	02/02/2001		63.0			F		On 12/01/00, the patient received Fluvirin vaccine in the left deltoid. Immediate pruritis at the site, Prescribed Ice. At 10 PM the axillary adenopathy, left arm acne. 12/02/00, malaise and flushed from 12 thru night and day: burning of both legs, PM of 12/02/00, at 6 PM  gradually lost sensation, then strength in both legs (Sat evening). 12/3/00, unable to move legs by 12 AM, crawled to bedroom, later dragged in to be seen by MD at 10 AM (Sunday).									U	12/02/2000			NONE	UNK	UNK	Acetaminophen, Medrol		History of allergies to vaccine 30 years previously (dust, alfalfa, moth, etc), environmental allergies, Foreign protein reaction, fever, adenopathy, Polyarthralgia.			1						1	Abasia; Acne; Asthenia; Flushing; Lymphadenopathy; Malaise; Pruritus; Skin burning sensation	FLU3~MEDEVA PHARMA, LTD.~E74040MA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0165542	02/02/2001		77.0	77		F		The patient received the flu shot on a Friday approximately 12/29/2000. Saturday morning the patient's arms and under arms broke out with red spots. In 3 days she was broke out all over her body. She went to the urgent care clinic the doctor said it was hives from the flu shot. She itched badly. She took medication 4 weeks then they were all gone.				Y					Y	12/29/2000	01/17/2001	19		UNK	UNK			NONE			1						1	Pruritus; Rash maculo-papular; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0165543	02/02/2001	KY	44.0	44		F	01/19/2001	On Wednesday, 01/17/01, the patient's left arm ached from the site where the shot was given down her hand. Thursday,01/18/01, the pain was better but still sore at the injection site. Friday, 01/19/01, having numbness on the left arm down to the hand. Feels tired all over with dizziness.									Y	01/16/2001	01/17/2001	1	NONE	PUB	PUB	NONE	States slight congestion	NONE			1						1	Dizziness; Fatigue; Hypoaesthesia; Injection site pain; Pain	FLU3~PFIZER\WYETH~4008207~4~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165544	02/02/2001	CA	56.0	56		F	01/09/2001	This patient has a runny nose, persistent bronchial cough, Phlegm in throat and chest, headache, eye hemorrhage in the left eye, no vision, vision unclear.				Y					Y	11/07/2000	11/19/2000	12	Laser surgery when Hemorrhage in left eye stops.	PUB	OTH	Glucophage, Glyburide, Diovan, Levothrud	NONE	Diabetes, Thyroid, Hypertension.	~Influenza (Seasonal) (no brand name)~~64.00~In Sibling|~Influenza (Seasonal) (no brand name)~~61.00~In Sibling		1						1	Blindness; Cough; Eye haemorrhage; Headache; Nasal congestion; Rhinorrhoea; Vision blurred	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0165545	02/02/2001	AZ	21.0	51		F		Pt was seen by a local physician who recommended EMG. 07/26/01 Follow up. This information was faxed to VAERS 05/18/2001. Per health dept, the date of the adverse event was 12/21/2000 and thet time 07:30am.				Y					Y	12/21/2000	12/21/2000	0		PUB	UNK		NONE	NONE		AZ0102	1						1	Unevaluable event	FLU3~PFIZER\WYETH~U008201~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0165546	02/02/2001	AZ	61.0	61		M	01/29/2001	15 hours after receiving immunization in the left arm the patient became swollen and painful with  red splotchy rash. Within 48 hours symptoms subsided.									Y	01/26/2001	01/27/2001	1	NONE	PUB	PVT	NONE	NONE	NONE		AZ0104	1						1	Erythema; Injection site oedema; Injection site pain; Rash; Rash maculo-papular	FLU3~PFIZER\WYETH~4008236~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~3312A4~2~IM~~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~658A4~2~IM~~HEP A (HAVRIX)~1|PPV~MERCK & CO. INC.~0945K~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0165579	02/05/2001	FL	2.0	1	1	F	01/26/2001	It was reported that a female pt received a Fluzone SV '00-'01 vaccination on 12/28/00. Reportedly, on 1/20/01, the pt was admitted to the hospital with the dx of respiratory distress. The pt spent 3 days in MICU. The pt's mother states that the pt is in fragile health so does not go out. Pt's mother and her husband have not had the flu and neither have the nurses who visit the pt. The pt's physician feels it was the vaccine which caused this. The pt is still having some respiratory problems but is getting back to baseline.					Y				N	12/28/2000	01/20/2001	23		UNK	UNK	Synagis				U2001002410	1						1	Respiratory distress	FLU3~AVENTIS PASTEUR~U0440AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0165582	02/05/2001	WV	68.0	68		F	01/23/2001	The morning after the vax, the pt complained of dizziness with a fever of 101.5 and chills. Fatigue, loss of appetite, body aches all over. The pt remained in bed for 2-3 days, drank fluids and took Tylenol. The area is approximately 2-3 inches in diameter with redness and induration on the right deltoid area. The arm is red hot to the touch and sore. The pt has experienced lingering fatigue.									U	01/16/2001	01/17/2001	1		PUB	PUB	Synthroid, amitriptylline, Vaycol, hydrocodone	NONE	Fibromyalgia, irritable bowel syndrome, thyroid disease, high cholesterol		WV0103	1						1	Anorexia; Chills; Dizziness; Erythema; Fatigue; Pain; Pyrexia	FLU3~AVENTIS PASTEUR~U0455AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~469133~1~IM~RA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~U0147AA~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0165773	02/05/2001	OR				F	01/02/2001	A pharmacist reported that a female received an injection on Influenza virus vaccine (manufacturer unknown) and subsequently experienced an anaphylactic reaction. The reporter did note that this information was questionable and there is no documentation of the reported event. Anaphylactic reaction is considered medically important.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ4464605DEC2000	1						1	Anaphylactic reaction	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165774	02/05/2001	OH	53.0	53		F	12/21/2000	Seven days post vax, the pt developed an injection site reaction characterized by a welt with itching and pain. The pt recovered.									Y	10/14/1999	10/21/1999	7	UNK	PVT	OTH	calcium; Celebrex; Claritin; Cleocin T; Entex LA; Evista; Flonase; folic acid; Omega-3 triglycerides;  Synthroid; Vitamin B-12; vitamins, other combinations	NONE	UNK		HQ2984031OCT2000	1						1	Injection site pain; Injection site reaction; Pruritus; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165775	02/05/2001	MD				F	12/21/2000	Subsequent to receiving vax, the pt developed a 4 X 8 cm wheal. She recovered.									Y				UNK	PVT	OTH	Prilosec	NONE	Gastro-oesophageal reflux disease		HQ4336601DEC2000	1						1	Injection site reaction; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165776	02/05/2001	KS				F	12/28/2000	Subsequent to receiving vax, the pt developed a severe nosebleed. The pt recovered.									Y	11/01/1999	11/01/1999	0	UNK	PUB	OTH	UNK	UNK	UNK		HQ4336801DEC2000	1						1	Epistaxis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165777	02/05/2001	MI	44.0	43		F	12/22/2000	Subsequent to receiving vax, the pt experienced bloodshot eyes. Follow up information was received 01/29/2001 from the original reporting nurse that indicated that the patient received Flu Shield (2000-2001 Formula) on an unspecified date. No adverse events or bloodshot eyes resulted.									U	01/01/1999			UNK	OTH	OTH	UNK	NONE	UNK		HQ4640208DEC2000	1						1	Ocular hyperaemia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165778	02/05/2001	NH				U	01/22/2001	Subsequent to receiving vax, the pt developed flu-like symptoms. No further information was available at the date of this report. Manufacturer's Comment: The reporter indicated that 39 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ4922215DEC2000	1						1	Influenza like illness	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165779	02/05/2001	KY	10.0			F	12/21/2000	Subsequent to receiving vax, the pt developed a low-grade fever (less than 100 degrees F) and general aching that persisted for one day.									Y				body temperature <100 degrees F	OTH	OTH	UNK	UNK	UNK		HQ4940515DEC2000	1						1	Pain; Pyrexia	FLU3~PFIZER\WYETH~~4~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165780	02/05/2001	KY	9.0			F	12/22/2000	Subsequent to receiving vax, the pt developed a low grade fever (less than 100 degrees F) and general aching that persisted for one day.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ5048319DEC2000	1						1	Pain; Pyrexia	FLU3~PFIZER\WYETH~~3~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165781	02/05/2001	KY	8.0			F	12/21/2000	Subsequent to receiving vax, the pt developed a low grade fever (less than 100 degrees F) and general aching that persisted for one day.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ5048419DEC2000	1						1	Pain; Pyrexia; Vaccine positive rechallenge	FLU3~PFIZER\WYETH~~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165782	02/05/2001	KY	7.0			F	12/21/2000	Subsequent to receiving vax, the pt developed a low grade fever (less than 100 degrees F) and general aching that persisted for one day.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ5048519DEC2000	1						1	Pain; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165783	02/05/2001	NH				U	01/22/2001	Subsequent to receiving vax, the pt developed flu like symptoms. No further information was available at the date of this report. Manufacturer's Comment: The reporter indicated that 31 employees experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ5954216JAN2001	1						1	Influenza like illness	FLU3~PFIZER\WYETH~4998212~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165784	02/05/2001	NC	54.0			F	12/22/2000	Pt reported that subsequent to receiving vax, she developed Bell's Palsy. No further information was available at the date of this report.									U				UNK	OTH	OTH	Glucophage; Hydrochlorothiazide	UNK	UNK		HQ3812116NOV2000	1						1	Facial palsy	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165785	02/05/2001	PA				F	12/22/2000	Subsequent to receiving vax, the pt developed a severe local injection site reaction.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ4336401DEC2000	1						1	Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165786	02/05/2001	MI				F	12/22/2000	Subsequent to receiving vax, the pt developed an injection site reaction characterized by severe pain and swelling. As of 12/13/2000, the pts arm remained tender. No further information was available at the date of this report.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ4858814DEC2000	1						1	Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165569	02/06/2001	CA	74.0	74		M	01/18/2001	One day post vax the pt had a sore arm and some slight bruising. The aching increased up into his neck with a bad headache, and eventually to both shoulders and down the other arm. By the next day his pain was so severe, his wife drove him to the ER. FU: pt passed away at home. Cause of death: myeloid leukemia and ASHD.	Y		Y	Y	Y	8			N	11/08/2000	11/09/2000	1	Blood work, Urine test, Bone Marrow	PUB	PUB	Tylenol #3, Atrovent Inhaler, Valium, Altace, Pravachol/Azmacort		Bronchitis, asthma, back and heart surgery history with back surgery 2 months previously and hayfever. Myeloid leukemia, ASHD.		CA000163	1						1	Arthralgia; Headache; Injection site haemorrhage; Injection site pain; Neck pain; Anaemia; Contusion; Difficulty in walking; Dysphagia; Fatigue; Headache; Injection site pain; Leukaemia; Memory impairment; Neck pain; Pain; Pharyngeal oedema; Platelet count decreased; Speech disorder; Syncope; Thinking abnormal; Tremor; Weight decreased; Anaemia; Anorexia; Blood disorder; Chest pain; Headache; Hypokinesia; Hypoxia; Malaise; Memory impairment; Myeloid leukaemia; Neck pain; Oedema; Pain; Pharyngeal oedema; Platelet count decreased; Pyrexia; Speech disorder; Tremor	FLU3~MEDEVA PHARMA, LTD.~E67330KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLU3~MEDEVA PHARMA, LTD.~E67330KA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~3	USA	Results in Death	Influenza
0165586	02/06/2001		22.0			F	01/17/2001	Given Rubella and Flu vaccine and 1/2 hour, post vax, had a headache and itching which continued into facial swelling, chest tightness and wheezing. Returned to UHS with symptoms and was given epinephrine and Benadryl IM and sent to ER.			Y	Y					Y	01/05/2001	01/05/2001	0		UNK	UNK			allergy to PCN, Iodine, shellfish			1						1	Chest discomfort; Face oedema; Headache; Pruritus; Wheezing	FLU3~PFIZER\WYETH~4008225~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|RUB~MERCK & CO. INC.~1020K~UNK~IM~~RUBELLA (MERUVAX II)~1	USA	Life Threatening	Influenza
0165595	02/06/2001	OH	28.0	28		F	01/17/2001	Within 30 minutes my left arm had shooting pain down to my pinky and ring finger (which went numb for several hours) and though my left shoulder. I still have a large lump and alot of pain in my shoulder and upper arm.									Y	01/15/2001	01/15/2001	0		OTH	OTH	NONE	NONE	NONE			1						1	Hypoaesthesia; Injection site mass; Pain	FLU3~PFIZER\WYETH~4008219~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165596	02/06/2001	IL	81.0	81		F	12/05/2000	Within 3-5 minutes after receiving the flu vac pt started swaying legs at arms back and fourth in a spastic movement - appeared to happen more with the right leg left arm. Pt was staring down an did not report to verbal question. No hx of seizures or hearing problems pt did not remember anything that occurred. Lasted about 10 seconds									Y	12/04/2000	12/04/2000	0	EEG to be done on 12/6/2000 as follow up to incidence	PVT	PVT		NO	NO		IL00073	1						1	Dyskinesia; Staring	FLU3~PFIZER\WYETH~4008180~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165597	02/06/2001	MN	36.0	36		F	01/24/2001	Less than 12 hours started cold/flu signs & symptoms runny nose, sore throat, cough. Less than 48 hours was in ER due to difficulty breathing. Have been ill on and off ever since (stomach flu, colds)				Y					Y	11/15/2000	11/17/2000	2		PUB	OTH	Prozac, Pulmicox					1						1	Cough; Dyspnoea; Influenza like illness; Pharyngitis; Rhinitis	FLU3~PFIZER\WYETH~4008174~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0165598	02/06/2001	MI	53.0	53		M	01/08/2001	Injection 11:30 -6pm soreness of arm, redness and swelling of arm from elbow to shoulder 36 hours started up inner arm into axillary. Chills, fever, lost of appetite, nausea.									U	01/05/2001	01/05/2001	0		PUB	UNK	NONE	NONE	NONE		MI2001004	1						1	Anorexia; Injection site erythema; Injection site oedema; Injection site pain; Nausea; Pyrexia	FLU3~AVENTIS PASTEUR~U0460AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~09446~1~SC~LA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~U0342AA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0165599	02/06/2001	MI	54.0	54		F	01/08/2001	24 hours after injection - fatigue, generalized achiness, arm was red, swollen & painful. Fever, headache, chills, redness size of grapefruit, loss of appetite.									Y	01/05/2001	01/06/2001	1		PUB	UNK	Prempro	NONE			MI2001005	1						1	Anorexia; Erythema; Fatigue; Headache; Oedema; Pain; Pyrexia	FLU3~AVENTIS PASTEUR~C0460AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~09440~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0165600	02/06/2001	MI	65.0	65		M	01/08/2001	Left arm swelling B/W elbow and wrist 2 x normal size. Red/warm to touch. Uncomfortable, painful to touch. Family provider seen on 1/4/01. Dx reaction to immunization, question pneumonia vaccine and or tx. Resolved by 1/8/01.				Y					Y	12/28/2000	12/28/2000	0		PUB	UNK	NONE	NONE	NONE		MI2001006	1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLU3~PFIZER\WYETH~4008224~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~468147~2~SC~LA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~U0342AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0165601	02/06/2001	MI	38.0	38		M	01/12/2001	Generalized redness in 24 hours. Friday 1/5/01 upper arm red and very painful. Today began to subside.									Y	01/03/2001	01/04/2001	1	NONE	PUB	PVT					MI2001007	1						1	Injection site erythema; Injection site pain	FLU3~AVENTIS PASTEUR~U0460AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~09440K~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0165602	02/06/2001	MI	48.0	48		M	01/12/2001	1/4 nausea and GI, 1/5 stiff neck, chest pain, swollen lymph groin, 1/6 achy, more chest pain, 1/8 severe chest pain with pleurisy. MD said maybe pneumonia vax.									Y	01/03/2001	01/04/2001	1		PUB	PVT					MI2001008	1						1	Chest pain; Gastrointestinal disorder; Lymphadenopathy; Musculoskeletal stiffness; Nausea; Pain; Pleurisy	FLU3~AVENTIS PASTEUR~U0460AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~09440K~1~SC~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0165603	02/06/2001	MO	47.0	47		F	01/23/2001	Immediately after receiving vaccine client c/o ringing in ears and lightheadedness. Had client lie down, elevated feet and used ammonia inhalant. BP consistent 94/46. Felt better in approx 10 minutes and BP 100/60 after walking around before release 1/18/2000. Client had no further problem.									Y	01/21/2001	01/21/2001	0	NONE	PUB	PUB	NONE	NONE	Hx of fainting or nearly fainting after shots esp. in Doctors office.		MO2001001	1						1	Dizziness; Hypotension; Tinnitus	FLU3~PFIZER\WYETH~4008233~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165604	02/06/2001	VA	33.0	33		F	01/17/2001	Approximately 12 hours post vax area around puncture site became swollen, warm and red. Used warm compresses. Still a problem next morning. Exam done by MD 24 hours post injection. Dx as local reaction to vax. Arm did not improve and patient saw private MD, dx cellulitis placed on Amoxicillin. 1/11/01 Arm improved. Pt incidentally developed pneumonia in both lungs and pancreatitis in the early post vax period.				Y					Y	01/09/2001	01/09/2001	0		PUB	PUB			Hep C, S/P splenectomy following MVA 9/2000.		VA01005	1						1	Cellulitis; Injection site erythema; Injection site oedema; Injection site reaction; Injection site warmth; Pancreatitis; Pneumonia	FLU3~PFIZER\WYETH~4008179~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~3376A4~3~IM~RA~HEP B (ENGERIX-B)~1|PPV~MERCK & CO. INC.~1070K~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0165605	02/06/2001	NC	33.0	33		F	01/23/2001	The pt states she awoke with pain in her left axilla, left arm and left inguinal groin area. States the left arm feels numb, tingly, and swollen. It was hard to put through ROM. wonders if related to injection on left side on 1/22.									U	01/22/2001	01/23/2001	1		PUB	UNK	PPD	NONE	allergy to Amoxicillin		NC00008	1						1	Groin pain; Hypoaesthesia; Joint range of motion decreased; Oedema; Pain	FLU3~AVENTIS PASTEUR~U0465AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0690K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0165632	02/07/2001	CA	86.0	86		F	02/01/2001	A telephone report was received from a pharmacist on 01/26/01, regarding adverse events possibly related to administration of Fluvirin. Approximately one month after receiving Fluvirin, an 86 year old female developed: muscle weakness in her legs, cerebral vasculitis (confirmed at lumbar puncture) psychotic behavior, and was confused and agitated. This patient has a history of: untreated Parkinson's disease, hypertension, non-malignant brain tumor, atrial fibrillation, and has had 2 breastectomies. She has recently been diagnosed with lumbar disc disease; the brain tumor has been further identified as an acoustic tumor. Attempts to gather additional data have been unsuccessful.					Y				U	12/01/2000	01/01/2001	31	Cerebrospinal fluid - cerebral vasculitis	OTH	OTH	NONE		Hypertension, atrial fibrillation, Parkinson's disease, Non-malignant brain tumor (acoustic tumor), lumbar disc disease, 2 Breastectomies.		MPI2001000630	1						1	Abnormal behaviour; Agitation; Cerebrovascular disorder; Confusional state; Muscular weakness; Psychotic disorder	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0165642	02/07/2001	KS	50.0	50		F	02/01/2001	An RN reported that, post vax, the 50 year-old Caucasian female with lymphoma and a history of cancer (type unspecified), chemotheraoy which ended in mid-September 2000. Upper extremity edema after receiving a tetanus injection and steroid therapy (prednisone) which stopped the last week of September 2000, who on 11/16/2000 was vaccinated with pneumococcal vaccine 23 polyvalent. (Lot 3 6945K invalid) intramuscularly in the left deltoid. Concomitant vaccination on 11/16/2000 included influenza virus vaccine (E64710HA) intramuscularly in the right deltoid. The pt experienced intermittent symptoms of achy left arm and pain that radiated down the left arm. The pt told the RN that once the arm ached so bad that it made her sick to her stomach. She also reported that the outer aspect of the elbow was sore to the touch but the pt stated that the elbow is better now. The pt told the RN that she had a lump under her left arm that comes and goes. The RN reported that the pt thinks the lump under her arm had to do with her lymph system. Unspecified medical attention was sought. In follow-up, the RN reported that on 11/16/00, shortly after receiving pneumococcal vaccine 23 polyvalent, the pt's left arm became sore and radiated downward toward the hand. She reported that a month later, the outer aspect of the elbow was sore to the touch, which comes and goes. She reported that the pt had enlarged lymph nodes which ached to the point of causing nausea, which she states occurs on and off. She stated that the pt's arm swelled when touched. The RN reported that the outcome of the pt's experiences were unknown. The sore arm, elbow sore to touch, enlarged lymph nodes, nausea and arm swelling were determined to be an Other Important Medical Event. F/U In follow up the registered nurse reported that the pt was seen by her private family physician and the pt was treated with antibiotics. The symptoms persisted. The pt was sent back to her oconlogist. Lymphoma had reoccurred. The pt has since undergone a bone marrow transplant. The worsening lymphoma required hospitalization and was considered life threatening. The sore arm, elbow sore to touch, enlarged lymph nodes, nausea and arm swelling were determined to be an other important medical event.  In FOLLOW-UP, the registered nurse reported that the patient had returned to teaching and was doing well as the time of the current report. She reported that the patient had a bone marrow implant in the summer of 2001 and had recovered from her experience No further information is available.				Y					U	11/16/2000	11/16/2000	0		UNK	UNK		Malignant neoplasm	Chemotherapy which ended in mid-September, 2000; steroid therapy (prednisone) which also ended in mid-September; vaccine reaction, lymphoma		WAES00120855	1						1	Injection site pain; Lymphadenopathy; Nausea; Pain; Swelling	FLU3~MEDEVA PHARMA, LTD.~E64710HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~6945K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0165643	02/07/2001	ND	60.0	60		F	02/01/2001	On 12/5/00, post vax, the pt experienced a reaction on her arm. She presented with diffuse erythema of upper right arm extending into axilla and down to her elbow. It was tender to palpation and hard to touch. In follow-up, the PA reported that the pt was seen on 12/7/00. The pt told the PA that she thought she was having an allergic reaction to the pneumococcal vaccine 23 polyvalent. She reported that within a few hours, post vax, she noticed redness, swelling and pain in the arm. This had progressed over the past day and now she had redness down the elbow and up into the axilla and back onto the right shoulder. On exam, the PA noted she had confluent, erythematous and a somewhat fluctuant area extending from the right axilla down to the right elbow. The fluctuance was mainly over the biceps but the tenderness to palpation was more noticeable in the right axilla and right posterior arm at the base of the right shoulder. The pt stated that she had some chills on 12/6/00. The pt took some extra strength Tylenol on 12/6/00. Pt reported she did not feel ill, just occasionally felt feverish. The affected area did not blanche to palpation. At this time the PA assessed the pt's condition as an allergic reaction to pneumococcal vaccine 23 polyvalent. The pt was given Benadryl 50mg IM and was advised to take 25-50mg every 6 hours. A line of demarcation was drawn around the erythematous area. The pt was advised not to take any acetaminophen if she started to feel like she had a fever until she took her temperature and to record it. If her temperature was over 100F she was to take acetaminophen. On 12/8/00, the pt was seen again by the PA. The pt reported that she was much improved and had no further chills. Her temperature has been normal and the redness was resolving nicely. On exam, PA noted that the erythema was fading, however, it had spread down her upper arm to just below the elbow but was resolving on the shoulder area and upper arm. He noted that the area looks much better than yesterday. The PA's assessment of the pt's condition was that she had an allergic reaction to pneumococcal vaccine 23 polyvalent. The pt was advised that she should take Benadryl on an as needed basis. The pt was also advised not to be vaccinated with this vaccine in the future. Additional information has been requested. The allergic reaction, diffuse erythema of the upper right arm extending into axilla and down to her elbow, and tender to palpation were considered to be an Other Important Medical Event. F/U The pt's adverse experiences were considered to be other important medical events by the reporter. Follow -up info rec'd from the physician's assistant indicated that the pt adverse events improved with Benadryl and tylenol. It was reported that the pt recovered on 12/7/00. No further info is expected.				Y					Y	12/05/2000	12/05/2000	0	BP-147/81; Temp-99.1F; Pulse-88. On 12/8/00 BP-156/80; Pulse-81.	PUB	UNK	Combivent, Lotrel, beclomethasone dipropionate, chlorthalidone		Allergy, aspirin; COPD; rhinitis		WAES00120597	1						1	Blood pressure increased; Injection site erythema; Injection site induration; Injection site pain; Injection site swelling; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0690K~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0165645	02/07/2001	KS	46.0	46		F	11/17/2000	The patient had vaccination, 3 days after her injection she noted a rash in her lower extremities, severe abdominal pain, and diarrhea followed. She saw an immunologist on 11/07/00. The doctor did a skin test  ( had throat swelling). Diagnosed with hypersensitivity vasculitis from the Flu vaccine. Recurrence more rash in the upper abdominal area, pain, diarrhea on 11/09/00. Finally the patient was admitted on 11/11/00 for 3 days.					Y	3			Y	11/02/2000	11/05/2000	3	CBC, Compreh. Metabolic panel and amylase - WNL. WBC - 17,000.	PUB	PVT	Claritan, Rhinacort, Albuterol	NONE	Seasonal allergies	Throat swelling and paralysis~Influenza (Seasonal) (no brand name)~~0.00~In Patient	KS200026	1						1	Abdominal pain; Diarrhoea; Leukocytosis; Pain; Pharyngeal oedema; Rash; Vasculitis	FLU3~AVENTIS PASTEUR~U0333AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0165652	02/07/2001	KS		44		F	11/29/2000	On 11/22/00, this patient was nauseated and achy all over. On 11/23/00, she felt achy and feverish, her left arm reddened and edematous; a bit larger than a 1/2 dollar. The edema went down gradually over several days. The patient complained of eyes feeling itchy on 11/24/00. The patient took Benadryl for several days.									Y	11/22/2000	11/22/2000	0		PUB	PUB	Vicodin, and Percocet.	Back pain, hospitalized 11/7/00 - 11/11/00.	Allergies to Keflex, Penicillin.		KS200027	1						1	Erythema; Eye irritation; Nausea; Oedema peripheral; Pain; Pyrexia	FLU3~PFIZER\WYETH~4008186~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165653	02/07/2001	KS	66.0	66		M	12/11/2000	This patient received a Flu vaccine on 12/04/00. The patient noticed hives on his back on 12/06/00. The hives continued to worsen, no respiratory distress involved. He was seen by the Doctor on 12/08/00. The patient couldn't verify if it was flu shot or not causing the hive episode.				Y					U	12/04/2000	12/06/2000	2	NONE	PUB	UNK		NONE	NONE		KS200028	1						1	Urticaria	FLU3~AVENTIS PASTEUR~U0447AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0165654	02/07/2001	KS	37.0	37		F	12/11/2000	This patient developed hives after receiving the Flu vaccine after about 4 hours. There was no respiratory distress, nothing else new or different in her life. This was her first flu shot.									Y	12/04/2000	12/04/2000	0	NONE	PUB	PUB	NONE	Cold, no Temp.	NONE		KS200029	1						1	Urticaria	FLU3~PFIZER\WYETH~4008175~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165655	02/07/2001	KS	59.0	59		F	12/12/2000	This patient began feeling achy within 5 hours after receiving vaccine. The patient also noticed headache, chills; within 2 more hours hands felt tingly, and hands and feet felt cold. Her temperature was 100.5 the next AM and then 2 days later 101.3 in the AM, it resolved by the 3rd day. The patient still felt drug out and fatigued.									Y	12/05/2000	12/05/2000	0	NONE	PUB	PUB		NONE	NONE		KS200030	1						1	Chills; Fatigue; Headache; Pain; Paraesthesia; Peripheral coldness; Pyrexia	FLU3~PFIZER\WYETH~4008190~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165656	02/07/2001	NH	52.0	52		M	01/24/2000	This patient had tingling in his arm, pain, and inability to use his right arm.				Y					N	11/29/2000	11/29/2000	0		OTH	PVT	PPD, right forearm, lot # L0519AA	NONE	NONE			1						1	Hypokinesia; Pain; Paraesthesia	FLU3~AVENTIS PASTEUR~U0434AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0165657	02/07/2001	KS	43.0	43		M	10/21/2000	This patient has diffuse paresthesia from the chest down, numbness of the fingers and toes. Lasting continually for 2 weeks.									Y	10/14/2000	10/14/2000	0	CBC, Chem, BH - Nml	OTH	PVT	NONE	NONE	NONE		KS200025	1						1	Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0165673	02/08/2001	PA	30.0			M	02/01/2001	A pharmacist reported that a 30 year old male received an injection of Flu Shield '00-'01 on 11/1/00. On 11/3/00, the pt developed a fever, headache and shingles. On 11/13/00, he experienced numbness. An MRI showed plaques on the spinal cord that are similar to multiple sclerosis. The reporter also indicated that a neurologist believes that the pt's symptoms are a central nervous system disturbance. As of the date of this report, the pt still had a sensory disturbance of his lower extremities. Neurological disorder is considered Medically Important.				Y					U	11/01/2000	11/13/2000	12	MRI-spinal cord plaques	PVT	OTH	UNK	NONE	UNK		HQ6660331JAN2001	1						1	Headache; Herpes zoster; Hypoaesthesia; Infection; Nervous system disorder; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0165674	02/08/2001	CT	74.0	74		M	06/12/2001	A spouse reported that her 74 year old husband developed atrial fibrillation and polymyalgia rheumatica approximately 3 weeks post vax. He was then prescribed Lasix for his heart, Coumadin for his blood, prednisone for his PMR and synthroid for his thyroid. He had previously not been on any medication and had no medical problems. He has has previous flu shots in the past without any problems. His symptoms included achiness in his hips, thighs and calves. He normally works out at a club three times per week, but has not been able to return to that activity. Additional information has been requested. Follow-up information received on 4/24/01, states that the physician identified as PCP wrote: I did not administer a flu shot to this patient. Additional information received on 06/05/2001, states that the day after receiving the flu vaccine, the pt woke up with severe pain in thighs, calves, and hips. A few days later, joint pain began. This pt also had fever to 102 and lost 22 lbs. The family physician started him on prednisone, plaquenil,and NHAID with good effect. As of 06/22/2001, his positive RF has persisted.				Y					N	10/10/2000	10/11/2000	1		MIL	OTH	NONE		NONE		MPI200100047	1						1	Arthralgia; Atrial fibrillation; Pain; Polymyalgia rheumatica; Pyrexia; Thyroid disorder; Weight decreased	FLU3~MEDEVA PHARMA, LTD.~59070GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0165676	02/08/2001	NY	13.0	13		F	02/07/2001	The pt experienced a tonic-clonic seizure 2 minutes post vax, lasting a few seconds. The pt has no hx of seizure activity and no other contributing past medical hx. Additional information has been requested.									Y	01/13/2001	01/13/2001	0		PVT	OTH	NONE		NONE		MPI2001000320	1						1	Convulsion	FLU3~MEDEVA PHARMA, LTD.~E64370HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0165677	02/08/2001	MT	45.0	45		F	01/24/2001	At 7:00PM the pt experienced s cough, then severe chills, nausea and headache lasting 12 hours. Her eyes were red, no white visible for 36 hours. Went to bed and took store brand Excedrin.									Y	12/08/2000	12/08/2000	0		PUB	OTH	Allegra, Vitamins, Calcium, Gingko Biloba	NONE	allergy to dust, grass, trees, mold etc.			1						1	Chills; Cough; Headache; Nausea; Ocular hyperaemia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0165727	02/09/2001	GA	71.0	71		F	01/20/2001	On 01/19/01, this patient received her vaccinations in the PM. Her arm started to swell, sting, and she complained of pain, and severe redness for several days. The patient took Tylenol when necessary and Ibuprofen for 2 days. Today the swelling and redness is decreased.									Y	01/19/2001	01/19/2001	0		PUB	PUB	Blood pressure, Vitamin E, and all purpose Vitamins.	NONE	Allergies to bee stings, wasp stings, and insect bites. Erythema.		GA01006	1						1	Injection site erythema; Injection site pain; Injection site swelling; Pain	FLU3~PFIZER\WYETH~4008182~7+~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0710K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0165728	02/09/2001	IL	28.0	28		F	01/25/2001	This patient had a rash on her face and upper chest area, it was itchy, and she had watery eyes. The patient took Benadryl and it resolved.									Y	12/01/2000	12/01/2000	0		OTH	OTH	NONE	NONE	NONE			1						1	Lacrimation increased; Pruritus; Rash	FLU3~PFIZER\WYETH~4008184~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165729	02/09/2001	MI				F	01/12/2001	Immediately following this patient's injection she experienced numbness and tingling in her hand on the side where the injection was given. She also reports a flushed hot sensation all over. Obese sickness had completely resolved within 2 hour or less, and there were no residual effects.  Follow up:  Patient lost to follow-up, cannot contact.									Y	01/05/2001	01/05/2001	0		OTH	PUB	UNK	NONE	Migraines		MT0105	1						1	Hot flush; Hypoaesthesia	FLU3~AVENTIS PASTEUR~UO428AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0165730	02/09/2001	TX	2.0	2	.8	M	01/12/2001	This patient's mother called, the patient vomited 2 times in 6 hours after his vaccination was given. He was fine within 12 hours.									Y	01/11/2001	01/11/2001	0		PVT	PVT						1						1	Vomiting	FLU3~PFIZER\WYETH~400022C~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165731	02/09/2001	TX	42.0	42		M	01/18/2001	This patient developed a sore throat with post nasal drip, a severe cough followed with a fever; within 2 days after his vaccination.									Y	01/11/2001	01/12/2001	1	NONE	OTH	PUB		UNK			TX01004	1						1	Cough; Pharyngolaryngeal pain; Postnasal drip; Pyrexia	FLU3~PFIZER\WYETH~4008226~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165732	02/09/2001	TX	59.0	59		F	01/16/2001	On Monday, 01/08/01, at 9 PM, the patient had a rash on her body. On Tuesday, 01/09/01, the patient experienced itching, hives and throat swelling. The doctor administered Cortizone treatment lasting 7 days. The patient stated by Thursday, 01/11/01, she had no signs of hives, itching, rash or throat swelling				Y					Y	01/08/2001	01/08/2001	0	NONE	PUB	PUB	Esterol, Lipitro	NONE	NONE		TX01003	1						1	Pharyngeal oedema; Pruritus; Rash; Urticaria	FLU3~PFIZER\WYETH~4008226~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0165833	02/13/2001	PA				F	02/01/2001	Light rash of lower extremities. No hives. Returned to clinic about 15 minutes, post vax. No SOB or dyspnea. Treated with Benadryl po X 24 hours.									Y	01/18/2001	01/18/2001	0		PUB	OTH		NONE	NONE			1						1	Rash	FLU3~MEDEVA PHARMA, LTD.~E67940KA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0165834	02/13/2001	PA	12.0			M	01/29/2001	Pt given flu shot in left deltoid and Pneumovax in right deltoid on 1/26/01. He presents to office with painful left arm and axillary lymphadenopathy.									U	01/26/2001	01/28/2001	2	NONE	UNK	UNK	NONE		Questionable asthma			1						1	Injection site pain; Lymphadenopathy	FLU3~MEDEVA PHARMA, LTD.~E64300HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0165835	02/13/2001	PA	73.0	72		M	01/26/2001	Pt received flu vaccine on 12/1/00 in left deltoid. On 12/14/00, pt complained of some pain at site and returned to clinic on 1/25/01 with severe pain, needle-like feeling in the area and swelling. MD noted some irregularity in area. Comfort measures employed, NSAIDS and pt referred to physical therapy.				Y					U	12/01/2000	12/14/2000	13		UNK	UNK	Phenytoin, lansoprazole, beclomethasone, albuterol, alendronate, simvastatin		Allergy to aspirin and caines group of anesthetics			1						1	Injection site pain; Injection site swelling; Paraesthesia; Injection site pain; Injection site swelling; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E67400RA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~E67400KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0165836	02/13/2001	MS	38.0	38		F	02/01/2001	Received pneumonia and flu vaccines on 1/30/01. Complained of right arm where pneumonia shot was given as being swollen and painful to touch. Site edematous and warm to touch.									N	01/30/2001	01/31/2001	1		PUB	PUB	Accolate, Vanceril	NONE	Ibuprofen, Keflex allergies; asthma		MS01005	1						1	Injection site pain; Injection site swelling; Injection site warmth	FLU3~PFIZER\WYETH~4008226~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~472210~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0165837	02/13/2001	NM	58.0	58		M	01/21/2001	On 1/18/01, begin having right ear and neck pain. At noon, started getting leg aches. PCP Rx's with antibiotic Zithromax X 5 days; beginning swelling and again went to PCP. Dx'd peritonitis and Rx'd another antibiotic but got GI symptoms. Rx'd with steroid for swelling; stayed swollen for 4 days. Saw PCP again on 1/23/01. On 1/18/01 had fever and chills. Went to dentist for cleaning on 1/3/01 and complained of gum discomfort on left side, 5 days later.				Y					Y	01/16/2001	01/18/2001	2		PUB	PUB	NONE	NONE	NONE			1						1	Ear pain; Gingival pain; Neck pain; Pain; Peritonitis; Pyrexia; Swelling	FLU3~PFIZER\WYETH~4008204~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0165863	02/14/2001	KY	57.0	57		F	02/08/2001	This patient developed swelling of his eyes 27 days after his vaccine, followed by fever, arthralgia, and pleural effusion. She was hospitalized from 01/04 - 01/10/01 with uncertain diagnosis 1. Seronegative RA, 2. viral syndrome, 3. Adverse reaction to vaccine. She is improving. Still has joint pain.				Y	Y	6			Y	12/11/2000	12/20/2000	9	Increased Sed rate, Pulmonary Infiltrate, Pleural Effusion.	PUB	PUB	ibuprofen, Prempro	NONE	Osteoarthritis		KY2001010	1						1	Arthralgia; Eye oedema; Laboratory test abnormal; Lung infiltration; Pleural effusion; Pyrexia; Viral infection	FLU3~PFIZER\WYETH~4008201~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0165874	02/14/2001	MA	8.0	8		M	02/08/2001	It was reported that an 8 year old male pt received a Fluzone SV '00-'01 vaccination on 1/16/01. Reportedly, the pt experienced a seizure 20 hours, post vax. New onset of seizures; no fever. Pt was evaluated in ER and discharged home. Further information is requested. F/U correspondence rec'd on 4/18/01, additional pt vaccine,resposible physician vaccine administrator and lab data were provided. F/U rec'd on 5/7/01, the following information was provided: vaccine was given in the pt's deltoid. The pt had no history of seizures before the vaccination. The current medical condition of the pt is stable, no seizures.				Y					U	01/16/2001	01/17/2001	1	CT scan -negative, EEG follow-up - no further seizure activity	PVT	OTH	Creon, Tobi, Pulmozyme, Adex, Multi-vitamin		NKDA, cystic fibrosis		U2001003740	1						1	Convulsion	FLU3~AVENTIS PASTEUR~U0402DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0165882	02/14/2001	MI	78.0	77		F	12/01/2000	The patient woke up on Thursday night with a red rash, now raised or blistered, over the entire body. On 12/21/00, follow up phone call with the patient. Contacted the doctor per PHN recommendation on 12/01/00. was instructed to take OTC Benadryl which resolved the rash. Encourage follow up with the doctor before taking another Flu shot. Elevated symptoms next time.									Y	11/29/2000	11/30/2000	1	NONE	PUB	PUB	NONE	NONE			MI2001012	1						1	Blister; Rash erythematous	FLU3~PFIZER\WYETH~4008190~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165883	02/14/2001	RI	54.0	54		F	01/11/2001	This patient had bad swelling of her cheeks and lips. She received a shot on 01/05/01 at 12 noon. On 01/06/01 in the AM Benadryl every 6 hors 01/06/01 - 01/07/01.									Y	01/05/2001	01/06/2001	1		OTH	PVT	Privil, Nedral, Prednisone, Lipitor.		Kidney disease, (2) kidney transplants.			1						1	Face oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0165884	02/14/2001	WI	79.0	79		F	12/13/2000	On 12/10/00 at 4 AM, the patient woke up with symptoms of diarrhea (approx 6 episodes) in a short time. Took Immodium. Same scenarios on Monday and Tuesday (12/11 & 12/12) of 2-3 episodes in the morning and early evening. Contacted HCP: informed them of many cases of diarrhea. Advised to take 3 doses of Immodium on Tuesday. No diarrhea today 12/13/00.									Y	12/07/2000	12/10/2000	3		PUB	PUB		NONE			WI0108	1						1	Diarrhoea	FLU3~PFIZER\WYETH~4008207~7+~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165885	02/14/2001	WI	58.0	58		F	12/11/2000	On 12/05/00, Wednesday night, the patient's body ached, headache, arms red, swollen. Took Ibuprofen, Doxycycline ordered by the PMD. Today arm red all away around, swollen, itchy, painful encouraged to recall HCP. On 12/19/00 the patient states arm much better, less red and swollen, but still firm and itching at the injection site. To call for an appt with HCP when road conditions improve.				Y					N	12/05/2000	12/06/2000	1	NONE	PUB	PUB	Premarin, Inderal, Prozac, Ketrofen.		NONE		WI0113	1						1	Erythema; Headache; Injection site hypersensitivity; Injection site induration; Oedema; Pain; Pruritus	FLU3~PFIZER\WYETH~4008193~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~467415~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0165886	02/14/2001	WI	74.0	74		F	01/16/2001	Vaccine was administered 11:45 on 12/19/00. At about 8 PM on 12/19/00 she had a slight numbness in her left hand. On 12/20/00, she experienced shoulder blade pain. The pain increased and varied in different parts on the left arm. She saw her primary MD on 01/02/01 or 01/03/01, because of pain and numbness in arm and fingers .The patient reported that she had nerve damage all over her arm. Treatment continues with Vicodin, Tylenol, exercises, heating pad, follow up appointments.				Y					N	12/19/2000	12/19/2000	0	Nerve Conduction test 01/11/01	PUB	PUB	Coumadin, MVI, Ca+, Norvasc, Vitamin C.	NONE	Hypertension, ovarian cancer 20 years ago, 12/5/00 surgery for colon cancer.		WI0110	1						1	Hypoaesthesia; Nerve injury; Pain	FLU3~PFIZER\WYETH~4008224~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0165887	02/14/2001	WI	48.0	48		F	12/21/2000	This patient had a red area, swollen, hot about 4 inches in diameter. On the 5th day the area became very hard and reported to Health Dept on the 6th day for advice. Pinpoint papule noted with appearance of whitehead. The patient was sent to PMD. The patient had been using cold compresses and taking Ibuprofen. The PMD reports possible cellulitis, patient put on Keflex.									Y	12/14/2000	12/19/2000	5		PUB	PUB		NONE	Had a local reaction to TD in the past- redness and swelling.		WI0109	1						1	Cellulitis; Injection site erythema; Injection site induration; Injection site oedema; Rash papular	FLU3~PFIZER\WYETH~4008207~6~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~UO433AA~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0165888	02/14/2001	WI	39.0	39		F	12/27/2000	This patient developed black and blue left arm and into left wrist 5 cm size lump above left collar bone. Called HCP and will be seen today.				Y					Y	12/21/2000	12/22/2000	1	Chest X-ray - awaiting results.	PUB	PVT	Celexa, Ibuprofen, Lorazapan.	NONE	NONE		WI0107	1						1	Contusion; Skin nodule	FLU3~PFIZER\WYETH~4008197~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0165889	02/14/2001	NM	79.0	78		F	02/09/2001	After receiving injection Pt developed immediate aching and pain at site. Pt has experienced aching at site extending down arm.  Pt reports limitation in motion, problem on going. Pt being sent to PMD for evaluation and work-up.				Y					U	12/14/2000	12/14/2000	0		PUB	UNK	vitamins	NONE				1						1	Injection site pain; Injection site pain; Joint range of motion decreased	FLU3~PFIZER\WYETH~4008196~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4008196~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0165890	02/14/2001	AL	1.94	1	.9	F	02/02/2001	Pt has fever of 103-104 for 2 days. Diagnosed with otitis media, seen in office 2/1 9:20-10:30am - treated with Amoxil, also received 2nd influenza vaccine, has history of reactive airway disease. Pt presented on 2/1 at 14:30 to ER with 103 temp, febrile seizure lasting 7-8 minutes stiffening of extremities, eyes rolled upward. Pt received IM Rocephin for otitis media. Pt discharged from ER at 0045 2/2/2001, alert, nontoxic.				Y					Y	02/01/2001	02/01/2001	0		PVT	PUB		bilateral otitis media	reactive airway disease, former 32 week preemie, develop delay, speech delay.		AL0101	1						1	Febrile convulsion; Otitis media; Pyrexia	FLU3~PFIZER\WYETH~4008226~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0165891	02/14/2001	OH	68.0	68		F	02/15/2001	12 hours post vax for flu had substantial muscle soreness, pain in arm at injection site and most of all in whole body side, shoulder, back neck back, Got massage therapy which helped reduce pain. 3 weeks post still having residual effects.									Y	01/10/2001	01/10/2001	0		PVT	UNK	Zantac 75, Prilosec	NONE	chronic sinus problems (nasal)	1998~Influenza (Seasonal) (no brand name)~~66.00~In Patient		1						1	Back pain; Myalgia; Neck pain; Pain	FLU3~PFIZER\WYETH~4008188~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165908	02/15/2001	VA	30.0	21		F	02/13/2001	A physician reported that a 30 year old female received an injection of vaccine, in November, 1990. In January, 2001, the patient was hospitalized for the diagnosis of pneumococcal sepsis, serotype 9N. While hospitalized, the patient was ventilator dependent for 3 days and had no urine output for 2 days. The reporter did note that the patient had received and injection of pneumococcal vaccine in September, 2000. Follow up information received on 04/04/2001, indicated that this patient was 31 years old and was hospitalized for more than 30 days. Upon further medical review the code of intubation NOS was removed from the case.					Y	30			U	11/01/1990	01/01/2001	3714	UNK	PVT	PVT	Prednisone	UNK	Systemic Lupus Erythematosus		HQ7116412FEB2001	1						1	Dysuria; Pneumonia; Sepsis	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~285908~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0165924	02/16/2001	ID	66.0	66		M	01/02/2001	This patient has Guillain Barre' Syndrome, He was hospitalized.  Follow up 07/06/2001: Final diagnosis was GBS.  Patient experienced other previous illnesses or medical conditions before the onset of GBS, however, it was not stated.  Patient was previously vaccinated with INfluenza prior.	Y		Y	Y	Y				U	12/01/2000	12/15/2000	14	CT Scan head, CBC Chem panel - All Wnl	PVT	PVT	Lescol, Verapamil, Zestril, Zantac, Coumadin, ASA, Vitamins	NONE	No known allergies, CAD, PVD, HTN, PUD, Oral CA, Hyperlipidemia		ID01003	1						1	Guillain-Barre syndrome	FLU3~PFIZER\WYETH~4008181~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Results in Death	Influenza
0165932	02/16/2001	TX	1.5	1	.6	M		The child was seen by a doctor for a viral illness and diagnosed with the flu. The father requested a flu shot for the child. The child screamed, held breath, left side tonic clonic seizure lasting 2-3 minutes, post ictal axillary temp during seizure of 101.				Y	Y	2			Y	02/06/2001	02/06/2001	0	Lumbar Puncture - CSF, Gluc 90, Prot 10, no growth, 1 WBC, U/A - Nml, CBC - Wnl, Chem: Gluc 170, CXR - Clear.	MIL	MIL	NONE	Viral URI with a fever	hx of seizure, breath holding and fever			1						1	Breath holding; Convulsion; Crying; Hypoglycaemia; Influenza; Pyrexia; Screaming; Viral infection	FLU3~PFIZER\WYETH~4008200~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0165933	02/16/2001	MD	72.0	72		F	02/09/2001	On 11/9 the pt experienced dizziness and the pt was sent to the ER. Treated for high blood pressure. Stated fluid behind ear. On 11/10 began medication for elevated blood pressure. On 11/16 and 17. went to ER, blood pressure still elevated. Sent to the ER for a 3rd time treated by neurology for viral infection.				Y	Y	2			Y	11/08/2000	11/09/2000	1	CT scan - neg, echocardiogram - nml, sinus x-rays	PUB	PUB		NONE	elevated cholesterol, allergies			1						1	Dizziness; Ear disorder; Hypertension; Viral infection	FLU3~MEDEVA PHARMA, LTD.~E68790KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0165948	02/16/2001	MD	34.0	34		F	02/01/2001	A 34 year old health care worker presented 12/19/00to request the Hep B vaccination, PPD placement, and the flu shot. On 12/21/00 the patient presented complaining of swelling and tenderness in the right supraclavicular area, no previous episode. No other area of tenderness, PPD negative. The area was examined by the RN and the MD. The right supraclavicular lymph node tender, moveable, 1 cm palpable. Injection site normal. The patient was told to take Tylenol or Motrin when necessary and return if not resolved in one week. Numerous follow up phone calls made unable to reach the patient. The patient presented to the MD today for unrelated problem. Reports that right supraclavicular pain and swelling completely resolved in 1-2 weeks after the injection. Area was examined no swelling, no tenderness, no cervical lad injection site WNL.									U	12/19/2000	12/21/2000	2		UNK	UNK	PPD, left forearm, 12/19/00.		Obesity, nonsmoker, no ETOH			1						1	Lymphadenopathy; Oedema; Pain	FLU3~MEDEVA PHARMA, LTD.~E64670HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~MERCK & CO. INC.~0490K~UNK~IM~LA~HEP B (RECOMBIVAX HB)~1	USA		Influenza
0165949	02/16/2001					F	01/26/2001	The pt complained of funny taste in mouth, palate, tingling in back of head. Went to ER on 1/3/01 and 1/10/01. Complained of decreased circulation in LUE and LLE.					Y				U		01/03/2001			UNK	UNK						1						1	Cardiovascular disorder; Dysgeusia; Paraesthesia	FLU3~AVENTIS PASTEUR~U0460AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0165950	02/16/2001	ID	49.0	49		F	01/04/2001	This patient's left arm had weakness and pain.				Y					N	12/05/2000	12/06/2000	1		PUB	PVT	Ibuprofen	NONE	NONE		ID01002	1						1	Hemiparesis; Pain	FLU3~PFIZER\WYETH~4008181~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0165968	02/16/2001	MS	43.0	43		F	02/15/2001	Fatigue, severe migrating arthralgias and myalgias (sometimes with swelling and erythema) for the past 9 months. Have tried NSAIDS and steroid injections.  Follow up 06/04/2001: Patient has not recovered from adverse event.  Fatigue, migrating joing, muscle pain, confusion, digestive problems, light-headed, ears ringing... 35-40 days plus several days left work early or come in late.									N	10/24/1999	11/01/1999	8	RF-1:320; ESR-3; Bone Scan-mild arthritic type changes	MIL	MIL	Norvasc	NONE	HTN			1						1	Arthralgia; Erythema; Fatigue; Joint swelling; Myalgia; Rheumatoid arthritis	ANTH~MICHIGAN DEPT PUB HLTH~FAV024~1~SC~LA~ANTHRAX (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4998235~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165970	02/20/2001	FL	69.0	69		M	02/13/2001	Received phone from from daughter of pt requesting manufacturer and lot number. Stated that her father died at 8:30 PM the day he received the flu vaccine from a heart aneurysm.	Y	11/15/2000							N	11/15/2000	11/15/2000	0		OTH	PVT		NONE				1						1	Aneurysm; Cardiac disorder	FLU3~MEDEVA PHARMA, LTD.~E71290LA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0165976	02/20/2001	CA	70.0			U	02/08/2001	On 01/28, this patient had progressive weakness of the lower extremities, aching and pain of lower extremities, numbness, and difficulty walking. The symptoms have been ongoing for 3 months.	Y		Y		Y		Y		N				Guillain Barre Syndrome	UNK	UNK			myelodysplastic syndrome			1						1	Asthenia; Difficulty in walking; Guillain-Barre syndrome; Hypoaesthesia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0165977	02/20/2001	CA	77.0	75		M	02/08/2001	On 01/19, this patient had weakness in all extremities and inability to walk. Diagnosis - Acute Guillain Barre' Syndrome.			Y	Y	Y		Y		N	12/01/2000	01/19/2001	49		MIL	UNK		NONE	allergy to ASA			1						1	Asthenia; Difficulty in walking; Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0165978	02/20/2001	CA	71.0	71		F	02/08/2001	On 12/08/00, this patient had a sudden onset of numbness and weakness. Diagnosed with Guillain Barre' Syndrome. The follow-up reports state hypertension, arthritis, leg cramps cataract surgery benign breast tumor, appendectomy before the onset of GBS symptoms as ongoing medical conditions. And prior to the onset of GBS symptoms, the pt also experienced headache.			Y	Y	Y		Y		N	11/03/2000	12/08/2000	35		PVT	PVT		NONE	NONE			1						1	Asthenia; Guillain-Barre syndrome; Headache; Hypoaesthesia	FLU3~AVENTIS PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0165979	02/20/2001	MN	73.0	73		M	02/15/2001	Following vaccination the pt's family noticed a sudden onset of confusion and mental deterioration in 1/99. A rapid progression from short-term memory loss to death in March 2000. A diagnosis of paraneoplastic disorder was given. Further information is requested.	Y								N	10/21/1998	01/01/1999	72		UNK	UNK					U2001004120	1						1	Amnesia; Confusional state; Mental impairment; Neoplasm	FLU3~CONNAUGHT LABORATORIES~0975770~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0165988	02/20/2001	NY	65.0	65		F	11/22/2000	Puffy arm and red from elbow to shoulder.									Y	11/15/2000	11/16/2000	1		PUB	PUB					NY521005	1						1	Injection site erythema; Injection site swelling	FLU3~MEDEVA PHARMA, LTD.~E64470HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1070K~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0165989	02/20/2001	NY	83.0	83		F		Thursday and Friday had a sore arm. Saturday, muscles ached and arm was red and hot from shoulder to elbow. States allergic to eggs, but eats baked products with eggs and eats 1 egg a week.									Y	11/30/2000	12/01/2000	1		PUB	PUB	Cardiac only		Allergy to eggs		NY521003	1						1	Injection site erythema; Injection site pain; Injection site warmth; Myalgia	FLU3~MEDEVA PHARMA, LTD.~E64470HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0165990	02/20/2001	SC	57.0	77		M	01/12/2001	Pt stated his left arm felt tight about 21:00 on 1/11/01. No complaint of pain or fever but did have some difficulty raising left arm to face. Left elbow area was red, ward to touch and swollen approx. 3/4 larger than the right elbow. Checked by doctor, who recommended Benadryl. Also advised to take Tylenol if needed. Keep left arm elevated when in bed and use warm compresses.									Y	01/11/2001	01/11/2001	0	NONE	PUB	PUB	Clonidine, imipramine, Prevacid, Kacodex, Metroproterenol, Menacycline		Gastric Ulcer, surgeries for aortic (1996) and abdominal (1998) aneurysms		SC0102	1						1	Feeling hot; Hypokinesia; Swelling	FLU3~AVENTIS PASTEUR~U0465AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~474936~UNK~SC~LA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~U0267AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0165991	02/20/2001	SC	65.0	65		F	01/03/2001	Pt complaining of burning pain around neck, jaw and both collar bones. Upset stomach with nausea and vomiting, heart pounding and shortness of breath. Pt instructed not to take flu shots in the future.									Y	12/07/2000	12/07/2000	0	NONE	PUB	UNK		NONE			SC00092	1						1	Dyspnoea; Heart rate increased; Nausea; Neck pain; Pain in jaw; Stomach discomfort; Vomiting	FLU3~AVENTIS PASTEUR~U0439DA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0165992	02/20/2001	SC	59.0	59		F	01/04/2001	Pt noticed, 3 days ago, that right arm deltoid muscle area began itching. Has 2 areas approx. 2 1/2 below site of Tetanus that is red and slightly warm feeling and looks better than they did; were almost red. Possible allergic reaction to TD vaccine.									Y	12/27/2000	01/01/2001	5	NONE	PUB	PUB	BP medicine and Estrogen	NONE	HTN		SC0101	1						1	Injection site erythema; Injection site warmth; Pruritus	FLU3~AVENTIS PASTEUR~U0439DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~U0267AA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0166015	02/21/2001	MO	51.0	51		M	02/12/2001	This patient had a Influenza vaccine 01/26/01 (Friday), woke up (Sunday) 01/28/01, with numbness and cold sensation in feet and legs. Progressively increased upward to the waist over a weeks time. Describes current numbness as 80% numb from waist down. Is seeking medical care from 2 physicians. MRI is scheduled.				Y					N	01/26/2001	01/28/2001	2	NONE	PUB	PVT	NONE	NONE	Allergies to Sulfa and Penicillin.			1						1	Hypoaesthesia; Peripheral coldness	FLU3~AVENTIS PASTEUR~U0460AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0165569	02/22/2001	CA	74.0	74		M	01/22/2001	The pt reports being completely well with normal blood tests 2 months prior during back surgery, yet after flue vaccination, he developed low platelet count, anemia and recently his bone marrow results showed leukemia. He has last 40 lbs. since November, and he has periods of extreme fatigue. He has been given 3 month to 1 year to live, but he is receiving 2-3 pints of blood every 2-3 weeks, so shows increased energy and appetite following the transfusions. He had no problem the way the shot was given. According to his wife, the next day, post vax, he had a sore left arm from where the shot was given, though there was only a slight bruising. The aching increased up into his neck, a bad headache and eventually to both shoulders and down the other arm. By that Friday evening, the pain was extreme and I drove him to the ER where he was treated with several shots of Demerol. After 2 or 3 hours, we came home, but he was still very miserable. About 03:00, Saturday AM, he demanded that the EMS by called as his throat seemed to be swelling shut and he could not really open his mouth or swallow. Any movement was terribly painful. That time the ER physician treated him for pain and did a CBC and UA. When I picked him up, we were told that his blood was very strange and to see out family MD on Monday AM. The MD saw him on Tuesday, 11/14 and ordered weekly CBC's, etc. After several weeks of this, he was referred to a hematologist. On 12/14, he was called to go to the hospital for a blood transfusion of 3 units of packed cells. They admitted him for the night. He had a reaction on the 2nd unit; his left arm swelled and hurt so they asked an orthopedist to see him. It was X-rayed and an antibiotic IV was started, followed by Keflex. A culture was done of the elbow, but apparently none found. He was given Prednisone for 1 week and felt much better. He was also put on ferrous sulfate for severe anemia. The platelets were still a major concern. Saw doctor on 1/4/01 and we were ordered to have another blood typing and received 2 more units of blood (or cells) the next day. He seems to be getting weaker, his legs refuse to hold him up at times, he shakes a lot and even sunk down to the floor the other night while going to the bathroom and had to have the fire dept pick him up. He had fallen, hitting his head. He hurts in almost every part of his body. His head and scalp have been extremely sore to touch this entire time. When he is not feeling well, he often doesn't thing well, remember or talk well, This is probably lack of oxygen in his blood, they say.	Y	02/23/2001			Y				N	11/08/2000	11/09/2000	1	Several Blood tests, Urinalysis.  X-Ray of the arm. Blood typing. A culture of the Elbow.  Bone Marrow.	OTH	UNK	ASA, Altace, Pravachol, Azmacort inhalers, Atrovent, Valium, Tylenol with codeine #3		Asthma, Heart bypass, Arthritis.			1						2	Arthralgia; Headache; Injection site haemorrhage; Injection site pain; Neck pain; Anaemia; Contusion; Difficulty in walking; Dysphagia; Fatigue; Headache; Injection site pain; Leukaemia; Memory impairment; Neck pain; Pain; Pharyngeal oedema; Platelet count decreased; Speech disorder; Syncope; Thinking abnormal; Tremor; Weight decreased; Anaemia; Anorexia; Blood disorder; Chest pain; Headache; Hypokinesia; Hypoxia; Malaise; Memory impairment; Myeloid leukaemia; Neck pain; Oedema; Pain; Pharyngeal oedema; Platelet count decreased; Pyrexia; Speech disorder; Tremor	FLU3~MEDEVA PHARMA, LTD.~E67330KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLU3~MEDEVA PHARMA, LTD.~E67330KA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~3	USA	Results in Death	Influenza
0166087	02/22/2001	CA	1.08	1	.2	M		The pt developed a fever of 103.5 and had a brief seizure lasting 4 minutes.				Y					Y	02/09/2001	02/09/2001	0		PVT	PVT	Amoxil, Ventolin	slight URI, possible asthma	asthma			1						1	Convulsion; Pyrexia	FLU3~AVENTIS PASTEUR~U00414BB~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0166088	02/22/2001	KY	7.0	7		M	02/12/2001	Pt's grandmother called and stated pt took one dose of flu vaccine 1/17/01 pt now complains of stomach ache, gas and vomiting. She said that after his 1st dose of flu vaccine before Christmas, he complained numbness of left side and sore throat, he went to Dr for those complaints and was told that he did not feel it was due to flu shot. Diagnosed with positive strept throat. Took antibiotics and recovered without problems.									Y	01/17/2001	01/18/2001	1		PUB	OTH					KY2001012	1						1	Abdominal pain upper; Flatulence; Hypoaesthesia; Pharyngolaryngeal pain; Vomiting	FLU3~PFIZER\WYETH~4008197~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0166112	02/23/2001	NY	32.0	32		F	02/21/2001	On 12/25/00, reported 1st symptoms of sinus congestion and uncontrollable coughing. On 1/3/01, seen in ER with numbness and paralysis. Transferred to another hospital where she was told the dx was Guillain-Barre Syndrome. Is recovering. 60 day follow up states patient is experiencing blurred vision in the right eye. Sinus infection starting 12/21/2000				Y	Y	3			N	11/10/2000	01/03/2001	54		PUB	OTH	augmentin, nicotine patch	Mitral vavle prolapse, Depression	mitral valve prolapse, depression			1						1	Cardiovascular disorder; Cough; Depression; Guillain-Barre syndrome; Hypoaesthesia; Paralysis; Sinus congestion	FLU3~AVENTIS PASTEUR~U0422BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0165514	02/26/2001	GA	89.0	89		F	02/16/2001	Information has been received from a physician concerning a 89 year old female who was vaccinated. Within 12 hours of vaccination the patient experienced severe fatigue, fever, muscle aches, and developed a skin rash on her lower extremities. The patient was diagnosed with vasculitis. Follow up from the physician indicated that the patient had a hypersensitivity vasculitis following her vaccination and was placed on steroids. Her symptoms are slowly improving. Upon internal review the vasculitis was determined to be an Other Important Medical Event. F/U from the pt's relative indicated that on 10/20/00 the pt had severe flu like symtoms. This lasted several days. In Nov her legs and feet were covered with red splotches. Pt has had swelling in her feet and legs. Pt has had problems with weakness, being jittery and nervous. The events were reported to be disabling. The pt has not totally recovered yet. Follow-up has amended this report to include the times of vaccination and the onset of adverse events as well as labs.				Y				Y	N	10/02/2000	10/02/2000	0	1/11/01 ESR was 77, 1/19/01 ESR was 61; skin biopsy-vasculitis	PVT	OTH	UNK		UNK		WAES01012726	1						2	Asthenia; Hypoaesthesia; Influenza like illness; Rash maculo-papular; Vasculitis; Asthenia; Fatigue; Feeling jittery; Hypersensitivity; Influenza like illness; Myalgia; Oedema peripheral; Pyrexia; Rash maculo-papular; Red blood cell sedimentation rate increased; Vasculitis	FLU3~PFIZER\WYETH~468148~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|PPV~MERCK & CO. INC.~U0449AA~UNK~~~PNEUMO (PNEUMOVAX)~1|IPV~UNKNOWN MANUFACTURER~~UNK~IM~~POLIO VIRUS, INACT. (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Disabling	Influenza
0166146	02/26/2001	LA	52.0	52		M	02/13/2001	On 2/2/01, approx. 18:00, feet started to itch, then broke out in hives on trunk and right hand started to swell then had hoarseness and sore throat. Went to ER at 19:00 and was there until 23:59 and went home. Put on Zantac and Benadryl. Was given IV and shot of Benadryl at 2nd time in ER. (Was at hunting camp, Friday, when reaction occurred. Returned home at midnight after being seen in ER. On 2/3/01, Saturday AM, symptoms of itching, hives and pain and swelling in both hands had returned. He then went to local ER and was seen by ER MD and wife states he was given IV and injection and sent home. Told at both visits to the ER's that it was an allergic reaction to the flu vaccine, as this was all that was different or unusual in his routine. He has had previous flu shots in the past years. He was improved after treatments and pain and swelling started to resolve. No breathing problems. No problems Saturday or Sunday. On Monday, 2/5/01, at approx. 07:00, had started to complain of pain and swelling in right hand and left hand and feet starting to itch again. Experienced sore throat and hoarseness again. He went to his local MD and was admitted to the hospital and given Benadryl, Zantac IV and other things pain meds) He was hospitalized from 2/5/01 until 2/8/01. Discharged on 2/9/01 and told by MD that he had Rheumatoid Arthritis and given Vioxx for pain and given Z-pack for inflammation. Wife comes to health unit today, 2/13/01, to inform me of pt's adverse reactions to flu vaccine. He is still having problems. Right hand swollen and pain in right arm. Also, feet have started to itch again as of yesterday. He is not convinced that he has Rheumatoid Arthritis and feels that his symptoms are still related to adverse vaccine reaction. Went to see another doctor for a second opinion and further treatment as he is very uncomfortable. It was suggested that he go to another hospital that has an arthritis clinic. Per annual follow up: Patient has had no more complications from the influenza vaccine from last year. He has not taken any more influenza vaccine as per doctor's order.				Y	Y	4			Y	02/01/2001	02/02/2001	1		PUB	PUB	Insulin X 2 per day, Glucophage, Altace, Lipitor, ASA	NONE	diabetes, heart disease		LA010204	1						1	Dysphonia; Hypersensitivity; Oedema peripheral; Pain; Pharyngolaryngeal pain; Pruritus; Rheumatoid arthritis; Urticaria	FLU3~PFIZER\WYETH~4008226~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0166153	02/26/2001	SC	69.0	68		F	02/01/2001	Pt came to clinic complaining of rash with itching on 1/26/01. States rash developed on 1/24/01. Rash observed by nurse on back, waist and under arm. Pt states she may have run fever. Pt instructed to take OTC Benadryl for itching. Pt called back on 1/29/01. She went to ER on 1/27/01 and was given cortisone injection and sent home on oral pk cortisone. Pt was instructed by ER to found out if she was allergic to component in Flu shot.				Y					U	01/22/2001	01/25/2001	3		PUB	UNK					SC0105	1						1	Pruritus; Rash	FLU3~AVENTIS PASTEUR~U0439DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0166154	02/26/2001	AR	44.0	44		M	01/16/2001	On 1/16/01, pt in for complain of soreness at injection site on left deltoid and across back, previously between shoulder blades since flu vaccine received on 11/7/00. States pain had been across chest also but that pain has since been relieved. States he saw MD on 12/15/00 for complaints and was treated with anti-inflammatory RX. Pt was advised to return to PMD ASAP. Pt was treated with Voltaren po and Flexeril po; dx was thoracic paraspinous spasm; pt was not recommended for additional follow-up after 12/20/00 appt.				Y					U	11/07/2000				PUB	PUB	Zyrtec and Flexeril po prn		History of Hep-B and Hep-C		AR1001	1						1	Back pain; Chest pain; Injection site pain; Muscle spasms	FLU3~AVENTIS PASTEUR~U0410AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0165889	02/27/2001	NM	79.0	78		F	02/09/2001	Upon receiving injection, client developed immediate aching and pain at site. Since that time, has experienced aching at site extending down arm. Also has limited motion. Problem is ongoing. Pt being sent to PMD for evaluation and work-up.				Y					N	12/14/2000	12/14/2000	0		PUB	UNK	Vitamins only	NONE			NM120004	1						2	Injection site pain; Injection site pain; Joint range of motion decreased	FLU3~PFIZER\WYETH~4008196~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4008196~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0166186	02/27/2001	MS	81.0	81		F	02/15/2001	Pt reports having a headache X 2 days, then nausea and vomiting X 1 day. Pt reports she was afebrile. Pt also reports an outbreak of fever blisters. Pt feel weak now. Pt encouraged to see MD for continued weakness.									Y	02/06/2001	02/06/2001	0		PUB	UNK			Type II Diabetes		MS01006	1						1	Asthenia; Headache; Nausea; Oral mucosal blistering; Vomiting	FLU3~PFIZER\WYETH~4008198~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0166188	02/27/2001	KS	33.0	33		F	02/20/2001	Approx. 2 days, post vax, the pt reached down to pick up child and felt a popping sensation. Resulted in pericarditis possibly. Fluid between lung and chest wall (left). Signs and symptoms continued: Hurts when you supine. Placed on steroids and Vioxx. Pain through my rib cage on left side. Amoxicillin on 2/20/01.				Y					U	11/21/2000	11/23/2000	2	Echocardiogram; CAT Scan of chest; Chest X-ray; CBC; Lupus test	OTH	PVT	Desogen	NONE	Allergy to Biaxin			1						1	Back pain; Chest pain; Pericarditis	FLU3~AVENTIS PASTEUR~U0414BB~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0166226	02/28/2001	MI	62.0	62		F	01/30/2001	This patient was admitted to the hospital, neurology consult. He had plasmapheresis 3 times. Then he was admitted to rehab at the hospital. Diagnosed with GBS, Hyponutremia, wound infect, leukocytosis, increased temperature			Y		Y				U	12/04/2000	12/22/2000	18		PVT	PUB	Thyroid	Breast cancer	Allergy to horse serum, breast cancer, NIDDM, hypothyroidism, HTN			1						1	Blood disorder; Electrolyte imbalance; Hyponatraemia; Infection; Leukocytosis; Pyrexia	FLU3~AVENTIS PASTEUR~U0403AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0166228	02/28/2001	TX	16.0	16		F	02/05/2001	Focal seizure, (right-sided) for about 5 minutes following influenza vaccine. Parent reports EEG done at hospital.				Y	Y				Y	01/22/2001	01/22/2001	0	EEG done at the hospital - no results	PVT	PVT	Singulair, Flovent inhaler, Serevent inhaler	NONE	Stable asthma			1						1	Convulsion	FLU3~AVENTIS PASTEUR~U0448AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0166219	03/01/2001	PA	19.0	19		M	02/23/2001	It was reported that a 19 year old male pt received a Fluzone SV '00-'01 vaccination on 11/22/00 at 18:00. Reportedly, by the end of December 2000, the pt developed an onset of transverse myelitis. Treatment of 5 day burst of IV steroids and oral steroids was given. The pt required 5 days of outpatient hospitalization. The pt's recovery status was not reported. Further information is requested.				Y	Y	5			U	11/22/2000	12/01/2000	9	MRI's; Spinal Taps; Blood work-results not provided	OTH	PVT		NONE	Attention deficit		U2001004280	1						1	Myelitis transverse; Myelitis transverse	FLU3~AVENTIS PASTEUR~U0335AB~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~AVENTIS PASTEUR~U0335AB~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0166231	03/01/2001	TX	27.0	27		F	02/09/2001	On 12/31/00, pt began feeling funny. On 1/1/01, pt started feeling tingling in hands, food tasted funny. Weakness in arms and legs on 1/3/01 and taste gone. Seen by MD on 1/2/01 with headache and congestion. No fever, no ST. MD thought it was ? allergic reaction to Prilosec. Seen by MD on 1/3/01 with ptosis and weakness. Currently recovering. Subsequently, dx'd with atypical GBS involving cranial nerves in particular. Per doc 210316, patient almost completely recovered, but still with occasional extremely tingling and scalp pain.  Follow up 07/06/2001: Patient did not experience any illness with in 4 weeks prior to onset of GBS.  Possible URI 2 weeks prior to onset.  A final diagnosis of GBS has been made as : Demyelinating polyneuropathy poss atypical GBS.					Y	10			U	12/19/2000	12/31/2000	12	Influenza and mono (-) MRI (-) CSF-increased protein	PVT	PVT		NONE	Acne; GERD			1						1	Ageusia; CSF test abnormal; Dysgeusia; Eyelid ptosis; Feeling abnormal; Guillain-Barre syndrome; Headache; Muscular weakness; Nasal congestion; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~E71760LA~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0166238	03/01/2001	CA	73.0	73		F		Rapid onset of leg weakness. Transverse myelitis and Guillain-Barre like illness with persistent neuropathy. Doubts it is from vaccine. Is improving. Also diagnosed with Urinary retention and constipation.  Follow up:  Final diagnosis (+) Guillain-Barre Syndrome.  Diagnosis was made by a neurologist.  The patient did not experience any other illnesses within the 4 weeks before onset of GBS.  The patient did however experience severe subluxating joints and uneven gait before the onset of GBS.  The patient never had GBS or a related illness.  The patient has previously been vaccinated with influenza.					Y	10			N	10/18/2000			MRI spine; EMG-nml	PVT	UNK	prednisone, zantac, provera, premarin, lasix, glyburide, arover, feso4, calcium, folic acid, naproxen, glucosamine chondrotin	Rheumatoid Arthritis	Rheumatoid arthritis, NIDDM			1						1	Constipation; Guillain-Barre syndrome; Muscular weakness; Myelitis transverse; Neuropathy; Urinary retention	FLU3~AVENTIS PASTEUR~U0333AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0166259	03/01/2001		30.0			M		Fifteen to seventeen hours following the patients immunization he awakened suddenly with nausea, stiff neck and pain in back. It resolved in approximately 12-15 hours. The patient reported 12 days later.									Y	01/09/2001	01/10/2001	1	NONE	MIL	MIL	Verapansil, ASA, Atenolol, Paroxetine	NONE	Patient has known med controlled A-Fib.			1						1	Back pain; Musculoskeletal stiffness; Nausea	FLU3~PFIZER\WYETH~4008215~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~CONNAUGHT LABORATORIES~APU0343AA~7+~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0166260	03/01/2001	OK	55.0	55		F	01/29/2001	On 1/27/01 the pt experienced a sudden onset of severe abdominal pain, cramping with nausea, dizziness, weakness and headache, unable to sleep at night. On 1/28/02, the pt experienced a headache, weakness, nausea vomiting, with confusion. The pt also experienced a fast heart rate, felt like I was going into coma. The pt took Motrin for the headache. The headache continues with weakness, joint pain.									N	01/24/2001	01/27/2001	3		UNK	UNK					OK0106	1						1	Abdominal pain; Arthralgia; Asthenia; Dizziness; Headache; Heart rate increased; Insomnia; Muscle spasms; Nausea	FLU3~PFIZER\WYETH~4008205~5~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEPA~SMITHKLINE BEECHAM~651A~1~IM~LA~HEP A (HAVRIX)~1	USA		Influenza
0166261	03/01/2001	DC	52.0	51		F	02/07/2001	10 days post vaccine, broke out in rash, blistered, itchy. Rash lasted about 2 weeks. No PCP visit or tx. Patient had 2nd Varivax on 2/21/01. No reaction as of 2/28/01.									Y	11/20/2000	11/30/2000	10		PVT	OTH	HRT	NONE	Allergy to PCN			1						1	Blister; Pruritus; Rash; Erythema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~0649K~1~IM~LA~VARICELLA (VARIVAX)~1|FLU3~MEDEVA PHARMA, LTD.~E65610HA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|VARCEL~MERCK & CO. INC.~0649K~1~IM~LA~VARICELLA (VARIVAX)~2	USA		Influenza
0166262	03/01/2001	VA	66.0	66		M	01/29/2001	Pt developed new onset, severe eczema starting several days post the influenza vaccine, in Oct of 2000. Despite attempts to treat this generalized, very itching, scaling rash, very dry skin, problem remains.									N	11/15/2000	11/22/2000	7		MIL	UNK		Membrane-Sclerosis, Glomerulonephritis.	Asthma, COPD			1						1	Eczema; Exfoliative rash; Pruritus	FLU3~PFIZER\WYETH~4008209~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0166263	03/01/2001	MA	45.0	45		F	02/12/2001	L shoulder rotator cuff tendonitis, resulting in frozen shoulder.									N	11/01/2000	11/08/2000	7	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Arthropathy; Tendonitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0166264	03/01/2001	OK				F	01/25/2001	Pt reports on 1/22/01 between 2-2:30pm - at 2am SOB, itching face, stomach, arms, legs,hives. Fast heart rate, went to ER was prescribed Prednizone, O2, inhaler breathing machine, Heparin lock to slow heart rate and breathing. Also pepcid, Rx for Prednizone, Atarax for itching.				Y					Y	01/22/2001	01/23/2001	1	CxR and blood work.	PUB	UNK			Asthma		OK0102	1						1	Dyspnoea; Pruritus; Tachycardia; Urticaria	FLU3~PFIZER\WYETH~4008205~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0166265	03/01/2001	IL	73.0	73		U		This patient had a small purple-red rash (vasculitis type) on arms, legs and feet edema.				Y					U	01/23/2001	01/28/2001	5		PVT	OTH		No acute illness	CAD, HTN, Elevated Cholesterol, Osteoarthritis.			1						1	Erythema; Oedema; Rash	FLU3~PFIZER\WYETH~4008224~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0166313	03/02/2001	NC	78.0	70		M	03/01/2001	This patient had Pneumovax in 1993. He was admitted with pneumococcal pneumonia with septic shock and positive blood cultures.			Y	Y	Y		Y		Y	12/09/1993	02/19/2001	2629	Positive blood culture - Strept pneumonia	PVT	PVT	Hismanal, dexamethasone, Uniphyl, Moduretic, Ventolin, Atrovent, Azmacort	Hypertension, COPD	Hypertension; COPD			1						1	Bacterial infection; Drug ineffective; Laboratory test abnormal; Pneumonia; Sepsis; Shock	FLU3~CONNAUGHT LABORATORIES~3E41033~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1417W~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0166324	03/02/2001	CA	54.0	54		F	02/19/2001	One day of fever to 101.5F; onset mid-December of tingling in hand, arm pain on total body involvement by latter January. On February 12, dx'd with Sjogren's Syndrome. 60 day follow-up states that there is a new diagnosis of MCTD (Standford) not Sjogrens as previously reported. Doc 210790, annual follow up states the following: swelling (hands, legs, feet) athritis pain. Also states that patient was type I diabetic, had asthma and had thyroid.			Y					Y	U	11/28/2000	12/15/2000	17	In pt's file	PUB	OTH	Humalog, Premarin, Flovent, Plaquenil, Naproxen, Cortisone	NONE	Diabetes Type I, Hashimoto's Syndrome, asthma			1						1	Arthritis; Connective tissue disorder; Oedema peripheral; Pain; Paraesthesia; Pyrexia	FLU3~PFIZER\WYETH~345~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0690K~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Disabling	Influenza
0166339	03/02/2001	WV	17.0	17		F	02/21/2001	Immediately after pt received vaccine, became unresponsive - unconscious. Pt was breathing and had steady pulse. Nurse used ammonia inhalant, pt responded to. Pt feel were elevated. Pt remained very drowsy but oriented. Pt was transported to ER for evaluation and released within 1 hour with dx of vasovagal response to vaccinations.				Y					Y	02/20/2001	02/20/2001	0		PUB	PUB	Depo provera	NONE	NONE		WV0105	1						1	Coma; Loss of consciousness; Somnolence; Syncope vasovagal	FLU3~AVENTIS PASTEUR~U0455AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0926K~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0165304	03/05/2001	MD	73.0	73		F	02/26/2001	A physician reported that a 73 year old female received Flu Shield and Pneumovax vaccines on 12/13/00. On 12/18/00, the patient experienced ascending paralysis and was diagnosed with Guillain Barre' syndrome. She was hospitalized where she was put on a ventilator. On 01/12/01, the patient had a tracheotomy. The reporter considered this event to be life threatening. This report of a serious, labeled event is being submitted in a 15 day time frame, as requested by FDA. A copy of this report has been forwarded to Merck, manufacturer of Pneumovax.			Y		Y				U	12/13/2000	12/18/2000	5	EMG - Positive for Guillain Barre' Syndrome.                                                          Electrophoresis of Cerebrospinal fluid - positive for protein.	PUB	PUB	UNK	NONE	UNK		HQ7513422FEB2001	1						2	Guillain-Barre syndrome; Paralysis; CSF test abnormal; Guillain-Barre syndrome; Hypoxia; Laboratory test abnormal; Paralysis; Antidiuretic hormone abnormality; CSF test abnormal; Guillain-Barre syndrome; Laboratory test abnormal; Paralysis; Paralysis flaccid; Pneumonia; Urinary tract infection	FLU3~PFIZER\WYETH~4008195~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1070K~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~PFIZER\WYETH~4008195~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~MERCK & CO. INC.~1070K~1~IM~RA~PNEUMO (PNEUMOVAX)~2|FLU3~PFIZER\WYETH~4008195~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~3|PPV~MERCK & CO. INC.~1070K~1~IM~RA~PNEUMO (PNEUMOVAX)~3	USA	Life Threatening,Hospitalisation	Influenza
0166384	03/05/2001	CT	40.0			F	02/27/2001	A pharmacist reported that a 40 year old female received an IM injection of Flu Shield on 02/20/01. The patient was noted to have Flu symptoms at the time of the vaccination. Two days following vaccination, on 02/22/01, the patient was admitted to an ICU in an unconscious state. The reporter thought that the patient was intubated and she was unarousable. She was treated with Acyclovir and unspecified antibiotics.					Y				U	02/20/2001	02/22/2001	2	UNK	PVT	OTH	Oseltamivir, vitamins NOS	Flu symptoms	UNK		HQ7683026FEB2001	1						1	Depressed level of consciousness; Hypoxia; Influenza like illness; Loss of consciousness	FLU3~PFIZER\WYETH~4008219~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0166389	03/05/2001	NJ	47.0	46		F		Report received 2/13/00, from a physician, regarding adverse events possibly associated with Fluvirin. A 47 year old female pt received the vaccination at the end of October, 2000 and within 2 weeks, she developed severe arthritic symptoms; took ibuprofen, with relief; stopped the ibuprofen and relapsed. In mid-December, she developed ascending numbness, from feet to neckline and the sensation of stocking/glove; not complete loss of sensation. On 1/01/01, she noticed electrical-shocking spasms. She has been prescribed a 21 day course of Ceftin for Lyme Disease-like symptoms; is also being treated with Pamelor some compound (carisoprodol and aspirin preparation), and Motrin. The pt had received her 3rd and final dose of Lymerix vaccine in June of 2000. The reporting MD questions interaction between Lymerix and Fluvirin or the possibly that Fluvirin stimulated on autoimmune reaction to trigger Lyme-like reaction. Additional information has been requested.									N	10/01/2000	01/01/2001	92	CT Scan of lumbosacral spine; MRI of brain and cervical spine; EMG; Spinal Tap and Blood work, done in mid-December to mid-January-all wnl.	UNK	UNK	NONE		June 2000, Respiratory infection		MPI2001002360	1						1	Arthralgia; Drug interaction; Hypoaesthesia; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E65630HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0166392	03/05/2001	AZ	42.0	42		F	01/31/2001	On 01/03/01, this patient developed hives approximately 6 PM, tightness in the upper chest, and difficulty breathing. The patient saw the doctor on 01/04/2001, said his lungs sounded like a 70 year old smoker in stead of a 42 year old non-smoker. Given breathing treatment on 01/04/01 and 01/05/01. Medications: Prednisone, Combivent inhaler, Atarax, and Zantac.			Y	Y					Y	01/03/2001	01/03/2001	0		PVT	PVT			Drug allergy to Zithromax, Adriamycin; Medical: MVP			1						1	Chest discomfort; Dyspnoea; Urticaria; Chest discomfort; Pruritus; Throat tightness; Urticaria	FLU3~AVENTIS PASTEUR~U0446AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~AVENTIS PASTEUR~U0446AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening	Influenza
0166433	03/05/2001	TX	19.0	19		M	01/30/2001	Rash around injection site immediately after injection. Pt was instructed by physician to take Benadryl. Rash resolving before pt left the office.									Y	01/15/2001	01/15/2001	0		PVT	OTH						1						1	Injection site rash	FLU3~PFIZER\WYETH~4008191~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0166434	03/05/2001	OH	42.0	42		F	01/21/2001	Hives for 3 days; arm also sore for 3 days. Had shortness of breath and sinus problems (bloody).									U	01/04/2001	01/05/2001	1		OTH	UNK		NONE				1						1	Dyspnoea; Epistaxis; Injection site pain; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0166435	03/05/2001	NC	67.0	67		F		Flu vaccine given and 24 hours later, pt noticed hives on legs. Went to Pharmacy and got Benadryl for hives. Three days later, 12/25/00, pt's arms and hands became swollen. Pt went to medical center where the doctor put her on steroids. Pt is doing fine now, 1/25/01. Pt also mentioned that husband got red spots and a fever blister, 12 hours, post flu vaccine.				Y					Y	12/22/2000	12/23/2000	1		PUB	PUB		NONE	NONE			1						1	Oedema peripheral; Urticaria	FLU3~AVENTIS PASTEUR~U0439FA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0166436	03/05/2001	AZ	33.0	3		F	01/24/2001	Routine TD given in clinic. Returned, 2 days, later with erythemic area 5 X 3, just proximal to elbow. Tenderness, inflammation. No lesions, no drainage.				Y					Y	01/12/2001	01/14/2001	2		PUB	PUB	metformin, Zantac, albuterol, MDI	NONE	Diabetes; asthma; GERD			1						1	Injection site erythema; Injection site inflammation; Injection site pain	FLU3~MEDEVA PHARMA, LTD.~E71770L~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0820K~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~U0362AA~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0166437	03/05/2001	TN	66.0	66		F	01/25/2001	Pt states had chills and fever, the night of the injection of pneumonia and flu vaccines. Right arm was red and swollen the morning after injection but no fever.									Y	01/24/2001	01/24/2001	0		PUB	UNK		Cold				1						1	Injection site erythema; Injection site swelling; Pyrexia	FLU3~AVENTIS PASTEUR~U0460AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1070K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0166438	03/05/2001	TX	21.0	31		F	01/28/2001	45 minutes, post vax, she had hives in both legs, lasted a few hours and was gone by morning. Told us about rash on 1/27/01.									Y	12/20/2000	12/20/2000	0		OTH	OTH	Ortho Tri-Cyclen	NONE	NONE			1						1	Urticaria	FLU3~PFIZER\WYETH~4008195~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0166439	03/05/2001	IL	58.0	58		F	02/08/2001	Pt experienced redness, pain, swelling and warmth on left upper and lower arm, the night of the injection. RN was notified the next morning. Instructed pt to take ibuprofen and consult MD. On 12/18/00, she saw MD and was dx'd with cellulitis and placed on Keflex. Contact made on 12/20/00 and condition is much improved.				Y					Y	12/15/2000	12/15/2000	0	NONE	OTH	PVT	UNK	NONE	NONE			1						1	Cellulitis; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~AVENTIS PASTEUR~U0454AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0710K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0166440	03/05/2001	IL	58.0	58		F	02/08/2001	Pronounced edema, redness and itching at injection site on right arm. Ice applied. Refused antihistamine. Arm checked in 30 minutes; at 45 minutes had swelling of right eye. Chlo-Amine tablets (4) given. Arm slowly improved. Continued with ice. Instructed to take Benadryl at home and call MD if condition worsens. At 16:00, arm checked and was much improved.									Y	12/15/2000	12/15/2000	0	NONE	OTH	PVT	UNK	NONE	NONE			1						1	Eye oedema; Injection site erythema; Injection site swelling; Pruritus	FLU3~AVENTIS PASTEUR~U0454AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0710K~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0166441	03/05/2001	IL	39.0	39		F	02/08/2000	Redness, warmth and pain in right arm, noted on 12/16/00. Pt applied ice and took Tylenol on 12/16/00. Reaction lasted approx. 3 days. Required no medical attention. Follow-up call on 12/19/00, pt states fully recovered.									Y	12/15/2000	12/16/2000	1	NONE	OTH	PVT	UNK	NONE	NONE			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~AVENTIS PASTEUR~U0454AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0710K~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0166599	03/06/2001	NJ	3.0	3		M	01/27/2001	Swelling and redness on the lateral aspect of left arm about 4cm X 4.5cm. No tenderness with hard center.									Y	01/25/2001	01/28/2001	3		UNK	PUB						1						1	Injection site erythema; Injection site induration; Injection site swelling	FLU3~PFIZER\WYETH~4008219~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PNC~PFIZER\WYETH~476724~1~IM~LA~PNEUMO (PREVNAR)~1	USA		Influenza
0166642	03/06/2001	MD	38.0	37		M	02/11/2001	The pt experienced urticaria.				Y					U	02/10/2001	02/10/2001	0		MIL	MIL	NONE	NONE				1						1	Urticaria	FLU3~PFIZER\WYETH~4008287~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEPA~MERCK & CO. INC.~1182K~1~IM~~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0166643	03/06/2001	MA	71.0	79		F		The pt developed swelling, erythema and pain at the injection site.									Y	10/23/2000	10/25/2000	2	NONE	PVT	UNK		NONE	CAD, s/p stent placement, elevated cholesterol, HTN, urinary incontinence			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4008171~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0166644	03/06/2001	VA	7.0	7		M	02/19/2001	One week post vax, the pt experienced hives.									U	01/08/2001	01/16/2001	8		PVT	UNK						1						1	Urticaria	FLU3~AVENTIS PASTEUR~U0465DA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0166645	03/06/2001	MN	26.0	26		F	02/04/2001	The pt felt nausea one hour post vax, joints began to get stiff and there is a tingling in the throat when breathing. Hot flashes, increased heart rate, and shortness of breath.									U	02/04/2001	02/04/2001	0		MIL	MIL	NONE	NONE	NONE			1						1	Dyspnoea; Heart rate increased; Hot flush; Joint stiffness; Nausea; Paraesthesia	FLU3~PFIZER\WYETH~4008287~6~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TYP~CONNAUGHT LABORATORIES~R0320~3~PO~MO~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0166646	03/06/2001	PA	47.0	47		F	01/31/2001	The pt experienced severe weakness, coughing, fever, chills. The pt required antibiotics.									Y	11/13/2000	11/13/2000	0		PUB	OTH		NONE	esophageal reflux, asthma, diabetes, allergy to sulpha, PCN			1						1	Asthenia; Cough; Pyrexia	FLU3~AVENTIS PASTEUR~U0406AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~459857~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0166647	03/06/2001	MN	1.0	1	.1	M	02/06/2001	The pt experienced erythema multiforme which started approximately 1 week post vax. Started with an urticarial rash, progressed to erythema multiforme with extreme swelling.				Y					Y	01/22/2001	01/30/2001	8		PVT	PVT	Augmentin	ear infection	NONE			1						1	Erythema multiforme; Injection site oedema; Urticaria	FLU3~AVENTIS PASTEUR~U0454AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0992K~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1137K~1~IM~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0166648	03/06/2001	MO	66.0	66		M	02/02/2001	The pt experienced aching in the left arm, migrating from the wrist to forearm to the elbow and shoulder five days post vax. Seen by a physician on 1/23/01. The pt was prescribed Neurotin.				Y					Y	12/12/2000	12/17/2000	5		PUB	PUB	Micronase, Glucophage	NONE	diabetes, hay fever			1						1	Pain	FLU3~AVENTIS PASTEUR~U0457AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0166649	03/06/2001	CA	27.0	27		F	01/26/2001	The pt experienced a rash covering entire body, itching, complained of feeling cold. Treated with Benadryl. Temp - 97.2, Pulse - 88, Respirations - 20, blood pressure - 120/80				Y					U	01/26/2001	01/26/2001	0	NONE	MIL	MIL	Synthroid	NOEN	allergy to sulfa, ASA			1						1	Body temperature decreased; Feeling cold; Pruritus; Rash	FLU3~PFIZER\WYETH~408222~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0166650	03/06/2001	WI	52.0	52		F	02/12/2001	The pt experienced a rash and pruritis. The rash started on upper back and abdomen, chest and arms. MD thought it may be reaction to flu shot.									Y	12/04/2000			NONE	PUB	PVT	Prozac, Pneumarine	NONE	NONE			1						1	Pruritus; Rash	FLU3~AVENTIS PASTEUR~U043AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0166651	03/06/2001	MO	49.0	49		F	01/10/2001	Three days post vax,  the pt experienced swelling, redness, and pain, from elbow to shoulder. Treated with Ibuprofen and ice for swelling. Incident resolved by the time it was reported.									Y	12/22/2000	12/25/2000	3	NONE	PUB	PVT		NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~AVENTIS PASTEUR~U045AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1217J~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0166652	03/06/2001	ND	31.0	31		F	02/05/2001	The pt experienced pain in the left arm, achiness all over, fever, chills, nausea and headache. Used analgesics and ice to the affected area. Had allot of pain for 3 days and then it lessened. The pt also experienced a hard lump at the site and a few red blotches on the left arm.					Y				Y	01/18/2001	01/19/2001	1		PVT	OTH		NONE	NONE			1						1	Headache; Injection site mass; Nausea; Pain; Pyrexia; Rash macular	FLU3~AVENTIS PASTEUR~U0460AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1068K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0166653	03/06/2001		26.0	26		F	12/07/2000	The pt experienced flushing, dizziness, nausea 10 minutes post vax. Treated with epinephrine. Symptoms resolved within 15 minutes.				Y					Y	12/07/2000	12/07/2000	0	NONE	MIL	MIL	Depo Provera	NONE	allergy to morphine, lortab, Benadryl			1						1	Dizziness; Flushing; Nausea	FLU3~PFIZER\WYETH~4008209~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0163464	03/08/2001	WA	30.0	30		F	12/01/2000	Pt started with chest tightness within 2 minutes, post vax. Pt was in acute respiratory distress; BP 160/100; rash on chest up into face; swelling of throat; pale skin; itching; hallucinations. Given IV Solu-Medrol, Benadryl and Epinephrine, SC with 4 days in the hospital. Don't take any further flu shots.			Y	Y	Y	4	Y		Y	11/30/2000	11/30/2000	0		PVT	PVT	BCP's. PPD, Connaught, lot # C0152AA, left forearm subdermal.	NONE	Hymenoptera allergy and flu shot allergy and allergy to morphine.		WA011719	1						2	Blood pressure increased; Chest discomfort; Hallucination; Pallor; Pharyngeal oedema; Pruritus; Rash; Respiratory distress	FLU3~PFIZER\WYETH~4008183~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Life Threatening,Hospitalisation	Influenza
0166732	03/08/2001	WA	75.0	75		F	01/30/2001	1 day, post vax, very weak and unable to get out of bed for 3 days. No appetite to eat or drink. Felt dreadful but able to get up off and on. Saw MD on Wednesday. Went to hospital. BP 80/50 for 2 days. Went home after rehydration. Home overnight and then to ER. She was admitted to hospital for 4 days, for tests. She was dx'd with Guillain-Barre Syndrome and discharged. She had no further progression of the neuropathy.					Y	4			Y	10/18/2000	10/19/2000	1	EKG; Spinal Tap; Blood work	PVT	PVT	HCTZ, Zestril, Potassium, Norvasc, ASA	NONE	Arthritis		WA011714	1						1	Anorexia; Asthenia; Dehydration; Guillain-Barre syndrome; Hypotension; Malaise	FLU3~AVENTIS PASTEUR~U0402DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0166733	03/08/2001	GA	73.0	73		F		Pain in legs, beginning 10 days or so, post vax. Gradually becoming worse; unbearable by mid November; feet numb; no paralysis. Treated with prednisone and Neurontin.  Diagnosed with autoimmune peripheral neuropathy. Doc 212685, annual follow up states that patient has numb feet and problem with balance.  Follow up 06/20/2001: Patient has not recovered from adverse event.  1981: Hypothyroidism, prescribed Syntroid-stable.  Patient did not receive any prior similar conditions before this adverse event. Other immunizations for influenza was 10/19/1999.  Final diagnosis if GBS has not been made.  Diagnosis changed from GBS to chronic inflammatory demyelinating polyneuropathy after biopsy. Consents for release of medical records and hospital discharge summary will be signed and returned to VAERS.					Y	4			N	10/04/2000	10/14/2000	10	EMG	PUB	PVT	Synthroid, hormones	NONE	Contact allergies			1						1	Balance disorder; Hypoaesthesia; Neuropathy peripheral; Pain	FLU3~MEDEVA PHARMA, LTD.~E59240GA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0166735	03/08/2001	NJ	18.0	18		F	03/01/2001	Notified by parent on 2/26/01 that on 1/12/01, daughter admitted to hospital after found unconscious at home. Lyme and MS ruled out by Neuro MD. Dx'd with ADEM related to pt receiving flu vaccine. Abnormal gait; incontinence and no short term memory.				Y	Y	9	Y	Y	N	12/08/2000	01/12/2001	35	Lyme disease and MS ruled out. MRI-abnormal	OTH	OTH	NONE	NONE	High cholesterol,hypertension, hypercholesterolemia			1						1	Encephalitis; Gait disturbance; Laboratory test abnormal; Loss of consciousness; Memory impairment; Urinary incontinence	FLU3~PFIZER\WYETH~4008217~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0166737	03/08/2001	GA				F		Body aching, neck pain, headache treated with Motrin. I believe vaccinated in 1979-1980.								Y	N					MIL	MIL	NONE	NONE	NONE			1						1	Headache; Neck pain; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0166770	03/08/2001	TX	52.0	52		M	01/18/2001	This patient complains that 48 hours later he developed a blotchy rash on his head and arms with an itch to his head. The patient took over the counter Benadryl with resolution of rashy itch.									Y	01/16/2001	01/18/2001	2		OTH	PUB		NONE	Allergy to Penicillin.			1						1	Pruritus; Rash; Rash macular	FLU3~PFIZER\WYETH~4008226~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~469133~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0166771	03/08/2001	WA	49.0	59		F	12/06/2000	This patient complained of upper respiratory infection since 11/23/00 and felt better. She had flu shot on 11/28/00. Complained of headache, sore throat, body ache, cough, nausea, vomiting, diarrhea, and a fever of 100.6. This patient had sickness for 5 days, she's feeling better today.									Y	11/28/2000	11/28/2000	0	NONE	OTH	OTH	Vitamin A, Trilisate, Maxide, Ranitadine.		Arthritis, GERD		WA011727	1						1	Cough; Diarrhoea; Headache; Nausea; Pain; Pharyngolaryngeal pain; Pyrexia; Upper respiratory tract infection; Vomiting	FLU3~PFIZER\WYETH~4008175~5~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0166772	03/08/2001	WA	66.0	66		F	12/06/2000	This patient had swelling right of her injection site, red with streaking into anterior shoulder, hot to touch, red translucent, large patch 4 x 5 anterior medial middle 1/3 of upper arm. Distal ok, temp 98.4.				Y					Y	11/29/2000	12/01/2000	2		PVT	UNK	Septra	Sinusitis	Allergy to Morphine.		WA011726	1						1	Cellulitis; Erythema; Injection site oedema; Injection site warmth; Sinusitis	FLU3~AVENTIS PASTEUR~UO337AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1197K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0166773	03/08/2001	WA	44.0	44		F	12/21/2000	Approximately 1 hour after her shot, this patient's arm developed stiffness, and soreness. By 4 hours, extremely stiff and sore, involving entire left deltoid region (Sternum - backbone) and part of the left side below. Approximately 5 hours after, the patient had a period of moderately tight chest and shortness of breath, some dizziness, stiffness and pain persisted all night; now resolving.									U	12/20/2000	12/20/2000	0	NONE	PUB	UNK	Zestril, Gingko Biloba.	Arthritis, Diabetes (type II)	Arthritis and diabetes type II		WA011725	1						1	Back pain; Chest discomfort; Dizziness; Dyspnoea; Musculoskeletal stiffness; Pain	FLU3~PFIZER\WYETH~4008202~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0166774	03/08/2001	WA	31.0	31		F	12/21/2000	This patient had tightness in her chest, shortness of breath, light headedness; starting about 2 hours after her injection. The patient admits history of panic attacks and states the symptoms are consistent with those.									Y	12/07/2000	12/07/2000	0		PVT	UNK	Dimetapp 12 hour Allergy.		Food Allergies (not eggs), asthma, bee sting.		WA011724	1						1	Chest discomfort; Dizziness; Dyspnoea	FLU3~AVENTIS PASTEUR~UO400AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0166775	03/08/2001	WA	71.0	71		M	12/21/2000	This patient received both his Influenza shot and Pneumonia shot on the same day. The arm became swollen, red, and hot. The swelling extended down the arm.				Y					Y	12/13/2000	12/14/2000	1	NONE	PUB	PVT		NONE	NONE		WA011723	1						1	Erythema; Injection site warmth; Oedema peripheral	FLU3~PFIZER\WYETH~4008202~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0956K~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0166776	03/08/2001	WA	20.0	20		F	01/26/2001	Within 24 hours following Wyeth brand flu vaccine, the patient had a local reaction approximately 2 1/2 x 1 1/2 redness on her right deltoid, warmth, and itching. Started on Zyrtec. Resolved on it's own no antibiotic needed.									Y	01/09/2001	01/10/2001	1		PVT	UNK	Paxil, Depo-Provera	NONE			WA011715	1						1	Injection site erythema; Injection site reaction; Injection site warmth; Pruritus	FLU3~PFIZER\WYETH~4008225~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0166777	03/08/2001	WA	53.0	53		F	12/08/2000	Pt reports after having flu shot that evening developed redness and swelling of upper arm, became more pronounced over next 2 days. Also had defined raised hive like rash .									Y	12/04/2000	12/04/2000	0		PUB	PVT			Horse serum allergy.		WA011710	1						1	Injection site erythema; Injection site swelling; Rash	FLU3~PFIZER\WYETH~4008193~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0166778	03/08/2001	PA	53.0	53		F	01/16/2001	This patient began experiencing itching and raised areas on her face, neck, back, and trunk of body on 01/16/01. Raised areas are erythemic and splotchy in appearance. Areas are fading at the present. The patient has not discussed with her MD. Denied any new foods, changes in behavior, and changes in medications. She planned to discuss with her MD. Denies any  problems with initially from the vaccine. Immunization site no evidence of erythema, edema, extreme, irritation or other problems.									Y	01/11/2001	01/15/2001	4	NONE	MIL	PUB	Luvox, Lithium, Clonipin.	NONE	Mental health meds only; had and allergic reaction last spring or summer on arms and legs. She doesn't know from what.		PA0116	1						1	Pruritus; Rash erythematous; Rash maculo-papular	FLU3~AVENTIS PASTEUR~UO428AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0166779	03/08/2001	MA	44.0	43		F	01/08/2001	Pt reports onset of severe vertigo, tinnitus, cold sweats, nausea and vomiting, feeling of being off balance, blurry vision with nystagmus. Unable to drive times 3 1/2 weeks due to incapacitating vertigo, relieved by lying flat in quiet room.				Y						10/17/2000	10/29/2000	12	WBC 18.8	PVT	PUB	Multivitamin					1						1	Hyperhidrosis; Nausea; Nystagmus; Tinnitus; Vertigo; Vision blurred; Vomiting; White blood cell count increased	FLU3~AVENTIS PASTEUR~U0346AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0166780	03/08/2001	MA	38.0	38		F	12/14/2000	Pt experienced tightness in chest, wheezing 3 minutes post injection.									Y	12/08/2000	12/08/2000	0		PUB	PUB			Pt had allergy to eggs as a child, but eats them all the time now.		MA0020	1						1	Chest discomfort; Wheezing	FLU3~AVENTIS PASTEUR~U0441AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0166781	03/08/2001	WI	14.0	15		M	01/16/2001	Pt received vaccine, several minutes later he became diaphoretic, flushed complained of lightheadedness and some tightness in his chest. BP 128/68, P88.Ten minutes later BP 120/60, P80, flushing and diaphoresis diminished.									Y	01/15/2001	01/15/2001	0		PUB	PUB	Albuteral, Singular, Flovent, Saconent		Asthma, allergies			1						1	Chest discomfort; Dizziness; Flushing; Hyperhidrosis; Asthma; Blood pressure increased; Chest discomfort; Dizziness; Flushing; Hyperhidrosis; Injection site mass	FLU3~PFIZER\WYETH~4008197~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0690K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~PFIZER\WYETH~4008197~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~MERCK & CO. INC.~0690K~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0166782	03/08/2001	CA	45.0	45		F	11/14/2000	Pt received vaccine this am. At 1:30pm pt complained of itching covering entire left arm. Treated with benadyl, ice.										11/14/2000	11/14/2000	0		PVT	PUB						1						1	Pruritus	FLU3~MEDEVA PHARMA, LTD.~E71760LA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0166783	03/08/2001	IL	19.0	19		F	02/27/2001	Redness, mild edema 5to 6cm around injection site.										02/19/2001	02/19/2001	0		PVT	UNK						1						1	Injection site erythema; Injection site oedema	FLU3~PFIZER\WYETH~4008201~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0166784	03/08/2001	MD	46.0	46		F	12/01/2000	Pt reports post 10 minutes of vaccine he felt funny, throat dry, burning in chest. Pt was able to breathe, no swelling noted, called 911.				Y						12/01/2000	12/01/2000	0		OTH	OTH	Tofronil, Avaolria, Glucophage	Diabetes, Cardiac problems	Diabetes, HTN, Cardiac problems.			1						1	Chest pain; Dry throat; Malaise	FLU3~MEDEVA PHARMA, LTD.~E64500HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0166785	03/08/2001	AZ	4.0	4		F	01/26/2001	This patient had localized cellulitis, tenderness, redness, and a fever.									Y	01/23/2001	01/26/2001	3	NONE	PVT	PVT	NONE	NONE	Reactive airway disease - moderate.			1						1	Cellulitis; Injection site erythema; Injection site pain; Injection site reaction; Pyrexia	DTAP~CONNAUGHT LABORATORIES~UO321BA~5~~RA~DTAP (TRIPEDIA)~1|FLU3~AVENTIS PASTEUR~UO446AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~CONNAUGHT LTD.~T0484~4~~RA~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0623E~2~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0166801	03/08/2001	NY	36.0			F	04/30/2001	A physician reported that a 36 year old female received an injection of influenza virus vaccine on an unspecified date. Eight days, post vax, the pt was hospitalized with meningitis. Additional information has been requested.					Y				U				UNK	OTH	OTH	UNK	UNK	UNK		HQ6348124JAN2001	1						1	Meningitis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0166802	03/08/2001	NH	48.0	48		F	01/08/2001	On 10/29/00 onset of nausea and dizziness while in shower, felt unsteady and off balance with whoring vertigo, bilateral tinnitus broke out in a cold sweat and vomited. On 10/30/00, had severe dizziness and was unable to walk without losing balance, veering off to sides. Seen by MD where I work and was given Vistaril IM for nausea and vomiting and scopolamine patches. On 11/2/00, seen in ER as there is no improvement and now also have blurry vision, no appetite with nausea and vomiting, severe tinnitus bilaterally and decreased hearing with bilateral ear fullness. Given IV Phenergan and Antivert. Dx'd with viral labyrinthitis that could take 3 weeks to go away. On 11/10/00, saw ENT because was getting worse; feeling weak and shaky. Rx'd with Valtrex and Valium. Had 3 subsequent flu visits with ENT and Rx'd prednisone, 2 more 7 days courses of Valtrex and Dyazide to decrease fluid in inner ear. Repeat Audiogram on 12/6/00 showed improvement. Unable to drive or work for almost 4 weeks due to severe vertigo and unsteady gait. On 12/29/00, developed swelling of right jaw and neck that is tender to touch and moves when swallowing but no sore throat. I have upper back pain (feel like my head is too heavy for my neck to support. Left arm and leg weakness. On 12/19/00, pt (functions continue to deteriorate). Fatigue and tires easily from 11/01/00 to present 1/8/01. Treatment: Vitamins, Tylenol, physical therapy, rest and flu shots.				Y				Y	N	10/16/2000	11/01/2000	16	CBC & Chem profile-WNL except WBC-18.8; Audiogram-showed sensorineural hearing loss;Xray-Cervical cord disc disease; lab work-(-); MRI- Acute demyelination disorder vs MS; EEG-(-); Lumbar Puncture-(-)	PVT	PUB	Glucophage, Norvasc, Multivitamins, Folic Acid; thiamine	NONE	NIDDM; HTN			1						1	Asthenia; Back pain; Balance disorder; Bone disorder; Demyelination; Dizziness; Ear discomfort; Hyperhidrosis; Hypoacusis; Labyrinthitis; Lymphoedema; Multiple sclerosis; Nausea; Pain; Tinnitus; Tremor; Vertigo; Vision blurred; Vomiting; White blood cell count increased	FLU3~AVENTIS PASTEUR~U0346AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0166842	03/08/2001	WA	51.0	51		F		This patient had local swelling, and soreness at the injection site. Prescribed Benadryl.									Y	12/18/2000	12/21/2000	3		PVT	UNK		NONE	GERD, smoking.		WA011716	1						1	Injection site oedema; Injection site pain	FLU3~AVENTIS PASTEUR~4008196~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0166843	03/08/2001	AZ	53.0	53		F	02/23/2001	On 01/04/01, this patient was given the Influenza injection to the left arm. Within 1 1/2 hours after the injection, the patient's upper arm became warm to the touch with a discoloration of red approximately 6 x 6 inches in diameter. Tenderness at the sight. Reaction lasted for 4 days. No sickness, nausea or vomiting, headaches, difficulty breathing. Informed to take Tylenol. Also the patient was seen by a military doctor who prescribed Benadryl and Hydrocortisone cream.									Y	01/04/2001	01/04/2001	0		MIL	MIL						1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~PFIZER\WYETH~4008215~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0166844	03/08/2001	CA	50.0	50		F	03/02/2001	This patient had a flu shot on 10/30/00 AM. He went to see the eye doctor 11/01/00 for another reason, but noted right eyelid drooping. Two weeks after, complained of tingling from both arms and legs and facial weakness. Two weeks after, hospitalized under telemetry x4 days due to complaints of weakness from both the upper and lower extremities with right weaker than left, tachycardia, and palpitation.				Y					N	10/30/2000	11/01/2000	2	12/00 Nerve Conduction test - Abnormal.                                                       Brain and C-spine MRI, Brain MRA, LP, Head CT Scan, and EMG - Normal results.	PUB	PUB	NONE	NONE	NONE			1						1	Ear disorder; Hemiparesis; Laboratory test abnormal; Palpitations; Paraesthesia; Tachycardia	FLU3~AVENTIS PASTEUR~U0400~3~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0166875	03/09/2001	NY				M		Telephone report received from a consumer on 02/27/01, regarding an adverse event possibly associated with Influenza vaccination. A retired veterinarian called to report that a male friend of his developed an autoimmune disease, glomerulonephritis, approximately 1 1/2 months after receiving an influenza vaccination. The patient required hospitalization and intravenous steroids. Recovery was complete; without known relapse. Medical history is significant for hypertension and hypercholesterolemia. This patient has had two subsequent influenza vaccinations without incident. No other info is available.				Y	Y				Y	08/01/1999	10/01/1999	61	Creatine-almost 5.0	MIL	OTH	NONE		Hypertension; high cholesterol		MPI2001019100	1						1	Blood creatinine increased; Glomerulonephritis; Immune system disorder	FLUX~UNKNOWN MANUFACTURER~~4~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0166876	03/09/2001	NY	85.0			F		Telephone report received from a consumer on 2/27/01, regarding an adverse event, possibly associated with influenza vaccine. A retired veterinarian called to report that approx. 2 weeks, post vax, in late 1998, a female friend of his developed temporal arteritis. This progressed to optic neuritis, with subsequent blindness in her left eye. She was hospitalized and treated with IV steroids. She continues to take oral steroids. There has been some improvement in her vision. No other information is available.					Y				N	11/01/1998	11/15/1998	14		OTH	OTH	NONE		Emphysema		MPI2001019120	1						1	Blindness; Optic neuritis; Temporal arteritis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0166882	03/12/2001	WA	6.0	6		M	12/05/2000	The patient's left arm was swollen, warm to the touch, and painful. A temperature was noted at school and checked by the school nurse. The school nurse sent the patient home and advised the mom to contact their doctor if it continues tomorrow or worsens today. To use Tylenol for the temp and pain, Benadryl for swelling, and ice and elevation for comfort, redness and swelling. Consult with the doctor.									U	12/04/2000	12/05/2000	1	NONE	PUB	PUB	NONE	NONE	NONE	~DTP (no brand name)~4~1.00~In Sibling	WA011709	1						1	Feeling hot; Oedema; Pain; Pyrexia	DTAP~SMITHKLINE BEECHAM~922A2~5~IM~LA~DTAP (INFANRIX)~1|FLU3~PFIZER\WYETH~4008173~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|IPV~CONNAUGHT LTD.~R12512~4~SC~RA~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~1181K~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0166980	03/12/2001	DE	40.0	41		M	03/05/2001	On 02/21/00, this patient was diagnosed with severe idiopathic cardiomyopathy. He had an URI approximately 3 weeks prior. (The patient understands idiopathic but believes this can be due to the vaccine). FU indicates onset of cardiomyopathy approximately 2/1/00.			Y		Y				N	11/01/1999				OTH	UNK		NONE	URI 3 weeks prior to vaccine.			1						1	Cardiomyopathy; Upper respiratory tract infection	FLU3~CONNAUGHT LABORATORIES~U0066BA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0167001	03/12/2001	UT	10.0	10		M	12/11/2000	Immediately, post vax of his daily injection of Humatrope, he had a seizure which lasted approx. 45 seconds. Mother stated he went rigid, held his breath and went blue. No previous history of seizures. No reaction with previous doses of Flu or Humatrope. Complained of headache the next day.									Y	12/05/2000	12/05/2000	0		PUB	PVT	Humatrope (daily by injection)	NONE			UT002729	1						1	Breath holding; Convulsion; Cyanosis; Musculoskeletal stiffness	FLU3~PFIZER\WYETH~4008193~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0167002	03/12/2001	GA	42.0	41		F	03/09/2001	Rash with induration; evaluated by MD and was given Benadryl and told not to get vaccine again.				Y					Y	11/09/2000	11/09/2000	0		OTH	PVT		NONE				1						1	Injection site induration; Injection site rash	FLU3~MEDEVA PHARMA, LTD.~E66330HA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0167003	03/12/2001	CA	62.0	62		F	02/23/2001	Client complained of hair loss and states the hair loss occurred after the 2nd dose of Hep-B vaccine.									U	10/05/2000	12/01/2000	57	NONE	UNK	UNK		NONE	NONE			1						1	Alopecia	FLU3~AVENTIS PASTEUR~U0465AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SMITHKLINE BEECHAM~3351A6~1~IM~RA~HEP B (ENGERIX-B)~1|HEPA~SMITHKLINE BEECHAM~667A6~1~IM~LA~HEP A (HAVRIX)~1|TYP~CONNAUGHT LABORATORIES~R11692~1~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0167049	03/13/2001	TX	11.0	12		M	03/16/2001	45 minutes to an hour after administration, while riding home in the car, the patient complained of a headache, became weak, and by history, lost consciousness. He recovered some what when he arrived home; remained weak, required assistance in walking, went to bed, slept for several hours. Normal upon awakening and has had no further problems.									Y	11/20/2000	11/20/2000	0	NONE	PUB	UNK	Albuterol, Naprosyn.		ADHD, Speech disorder, Asthma, Erythromycin Allergy.			1						1	Asthenia; Difficulty in walking; Headache; Loss of consciousness	FLU3~AVENTIS PASTEUR~UO410AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~SMITHKLINE BEECHAM~668A2~1~IM~LA~HEP A (HAVRIX)~1	USA		Influenza
0167050	03/13/2001	NC	53.0	53		F	03/05/2001	This patient had brachial plexus neuropathy occurring without injury. Started after the flu vaccine was given.									U	01/04/2001	01/05/2001	1		MIL	OTH	Nadalol, HCTZ.	NONE	Novacane.			1						1	Neuropathy	FLU3~PFIZER\WYETH~4008222~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0167051	03/13/2001	WI	39.0	39		F	03/06/2001	This patient had soreness at the site of injection, 12/07/00. The she began to develop  muscle soreness, tightness in legs, that moved into her arms beginning 12/07/00. This continued through the end of January 2001. The patient was off of work from 01/02/01 to 01/19/01, due to severe fatigue, and weakness. The patient was never really evaluated by MD. She saw a hygienist for holistic treatment at the end of Jan 2001. Completely recovered as of 03/06/01. This report was completed only after the patient was relaying the problem to the school nurse.									Y	12/06/2000	12/07/2000	1	NONE	PUB	PVT	Metracycline, birth control.	NONE	Seasonal allergies.			1						1	Fatigue; Injection site pain; Myalgia	FLU3~AVENTIS PASTEUR~UO399CA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0167077	03/14/2001	MI	83.0	83		F	01/12/2001	On 1/12/01, telephone call received from daughter of client who relayed that her mom was transported to health dept for a flu shot on 1/2/01 by personnel from adult care facility at 13:00. When client awoke in the AM of 1/3/01, she was unable to walk, write, had swallowing difficulties and slurred speech. She was taken by the facility's staff to ER at 16:00 on 1/3/01. She was admitted to the hospital where testing was done but daughter unsure of specific tests. Daughter stated physicians said it wasn't a stroke. She is slowly recovering.					Y	7			Y	01/02/2001	01/03/2001	1		PUB	PUB	Diovan, Pepcid AC, Lanoxin, Amoril, Coumadin KCL, Lasix, Nitro-Dur, ibuprofen, Patch Mg oxide		History of 2 strokes (1996 and 3/1998); DM; 2 endarterectomies (1997 & 12/99); quadruple bypass surgery 8 or 9 years ago. Allergies to bee stings, PCN, Percodan, Percocet; adhesive tape, Macrodantin, iodine/Betadine.	Exhaustion and movements reduced~Influenza (Seasonal) (no brand name)~1~82.00~In Patient	MI2001017	1						1	Abasia; Dysarthria; Dysphagia	FLU3~PFIZER\WYETH~4008224~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0167078	03/14/2001	ID	45.0	45		F		This patient had Guillain Barre' Syndrome, vent required.			Y	Y	Y		Y		U	01/03/2001	01/12/2001	9		PUB	UNK			Allergies to Lortab. History of asthma.		ID01008	1						1	Guillain-Barre syndrome; Hypoxia	FLU3~PFIZER\WYETH~4008180~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0166261	03/15/2001	DC	51.0	51		F	02/21/2001	Isolate red dot, itch; started at stomach, then whole body, which lasted 2 weeks.									Y	11/20/2000	12/02/2000	12		PVT	OTH	PPD/Pharma Limited/C0150AA/ID/0 previously					1						2	Blister; Pruritus; Rash; Erythema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~0649K~1~IM~LA~VARICELLA (VARIVAX)~1|FLU3~MEDEVA PHARMA, LTD.~E65610HA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|VARCEL~MERCK & CO. INC.~0649K~1~IM~LA~VARICELLA (VARIVAX)~2	USA		Influenza
0167218	03/15/2001	WA	62.0	62		F	03/02/2001	Persistent pain in left deltoid (now 3 M post injection); numbness down extensor of forearm and back of hand since then. Decreased light touch dorsal/above left hand, light touch intact over forearm.									N	12/12/2000	12/12/2000	0		PVT	OTH	Levoxyl, Paxil, Diltiazem, Trazodone, Estratest		Hypertension, hypothyroidism, menopause, GERD			1						1	Hypoaesthesia; Pain	FLU3~PFIZER\WYETH~4008193~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0167219	03/16/2001	GA	41.0	41		F	02/22/2001	This patient's left arm (where the shot was given) broke out in a rash from her elbow to her shoulder. She took oral Benadryl and rubbed Cortisone cream on the rash to prevent itching. It went away in 2 1/2 days.									Y	11/07/2000	11/08/2000	1		OTH	PVT		NONE	Allergies to pollen			1						1	Injection site pain; Rash	FLU3~MEDEVA PHARMA, LTD.~E70180KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0167220	03/16/2001	MI	50.0	50		M	02/18/2001	My arm had a 3 X 2 swollen area around area where follow-up shot was given. It was warm and hurt to touch and it lasted for several days.									Y	12/15/2000	12/16/2000	1		OTH	PUB	Verelan					1						1	Injection site pain; Injection site swelling; Injection site warmth	FLU3~PFIZER\WYETH~4008183~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0167221	03/16/2001	TX	58.0	57		F	03/06/2001	On 02/19/01 - This patient had Pneumovax and Flu vaccine given . On 02/20/01- She had a fever of 102, feeling out of it, red local reaction at the injection site. On 02/21/01, more of the same very sick, rash on her arm 02/22/01 to sick to see a doctor. She went in to see the doctor on 02/23/01, severe rash, stared on Prednisone. On 02/24/01 reactions stopped , getting bigger. On 02/25/01 reaction much better, patient may stop medication. She wanted to keep taking the med. On 02/26/01, she saw the reactions again much better still recommend taking meds until Wednesday at least. Reaction at it's worse was red, itchy rash from shoulder to the elbow and half way around arm. Even blistered up with clear blisters. Later blood blisters evolved. As reaction started clearing up rash area turned yellow like bruising patient stated arm still stinging at the rash site.									Y	02/19/2001	02/20/2001	1		OTH	PVT						1						1	Blister; Contusion; Erythema; Injection site pain; Injection site reaction; Malaise; Pruritus; Pyrexia; Rash	FLU3~PFIZER\WYETH~4008233~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1197K~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0167380	03/20/2001	RI	68.0	68		M	03/13/2001	On 12/8/00, pt had clumsiness; dropping tools. On 12/9/00, had difficulty with balance and swallowing. On 12/10/00, could not move without assistance and had slurred speech. Miller-Fisher variant of Guillain-Barre. Still hospitalization. 60 day follow-up states the pt was discharged from the hospital on 5/7/01.					Y		Y		Y	12/07/2000	12/08/2000	1		PVT	PVT		NONE	NONE			1						1	Asthenia; Balance disorder; Clumsiness; Dysarthria; Dysphagia; Miller Fisher syndrome	FLU3~AVENTIS PASTEUR~0449AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0167396	03/20/2001	DE	80.0	80		F	11/14/2000	Bruise came, 2 days, post vax, on right arm with swelling that appeared on 11/12/00.									N	11/03/2000	11/05/2000	2		PUB	UNK	Blood pressure medicine; Lasix	NONE	High blood pressure			1						1	Contusion; Injection site swelling	FLU3~AVENTIS PASTEUR~U0406AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~469133~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0167584	03/21/2001	UT	39.0	39		M	03/06/2001	After the patient received his vaccine, he said it was like he had went to the dentist, the left side of his face was numb. The next day his eye was giving him trouble. On the third day his mouth was not working. They bandaged the eye up to keep it moist.					Y			Y	N	11/24/2000	11/24/2000	0		OTH	OTH			Diabetes, High blood pressure.			1						1	Eye disorder; Hypoaesthesia; Movement disorder	FLU3~PFIZER\WYETH~4008202~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0167590	03/21/2001	IN	2.0	2	.6	M	03/15/2001	5cm area of redness and swelling on left deltoid reported the evening following injection day. Doctor on call, recommended that mother give Tylenol for discomfort and ice to area. Seen the following AM. No change in treatment.				Y					Y	02/13/2001	02/14/2001	1	NONE	PVT	PUB	Tylenol for pain and fever	NONE	Mild intermittent asthma			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~AVENTIS PASTEUR~U0455AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~476724~1~IM~LA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0167597	03/21/2001	CA	78.0	78		M	03/12/2001	Fever, pleural effusion, Eosinophils in fluid and marked Eosinophils in peripheral blood.				Y					Y	11/27/2000	12/02/2000	5	CBC; CXR-Pleural fluid; multiple blood tests	PVT	PVT	Levothroid; Indocin; Valium	NONE	Allergy to PCN; Hypothyroidism, BPH			1						1	Laboratory test abnormal; Pleural effusion; Pyrexia	FLU3~PFIZER\WYETH~4008186~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0167598	03/21/2001	WA	20.0	20		F	03/15/2001	Roughly 1 hour, post vax, developed chest tightness, SOB, itchy rash, with pruritus, mild wheezing and periorbital edema but vitals stable. Received Epi, Benadryl and albuterol nebulizer. Resolved, sent home with prednisone.				Y					Y	03/15/2001	03/15/2001	0	NONE	MIL	MIL	ibuprofen	NONE				1						1	Chest discomfort; Dyspnoea; Periorbital oedema; Pruritus; Rash; Wheezing	FLU3~PFIZER\WYETH~4008215~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEPA~MERCK & CO. INC.~0313K~2~IM~RA~HEP A (VAQTA)~1|TYP~CONNAUGHT LABORATORIES~R0324~1~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|YF~CONNAUGHT LABORATORIES~UA341AA~1~SC~LA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0167623	03/21/2001	CA	76.0	77		F	03/20/2001	The pt, a 77 year old female, reported that within 3 days, post vax, she developed flu-like symptoms of general aching all over her body, weakness, loss of appetite; physical condition continued to worsen each day. By the 4th day, she experienced difficulty breathing. She was seen in the ER where, after X-ray, 1 liter of fluid was removed from her lung. Eleven days, post vax, she developed itchiness, rashes and small blisters on her back, inner thighs and ankles. The fronts of her legs had red, feverish lumps beneath the surface of skin, with fluid retention around her ankles. The rash subsided within a week, but the heavy welts on her feet and palms of hands and itching persisted for 10 more days. All adverse events, except the ankle edema have completely resolved. The ankle edema continues to be treated with HCTZ, 25 mg per day. The pt stated that the dx of pleural virus was made. No additional information is available.				Y					U	11/17/2000	11/20/2000	3	CXR-fluid in lung; CXR-neg for cancer; CT-3 small spots on liver; EKG-UNK	PVT	OTH	Lysine, multivitamin, calcium		Post right breast lumpectomy for breast cancer, treated for 4 years with Tamoxifen.		MPI2001037380	1						1	Anorexia; Asthenia; Dyspnoea; Influenza like illness; Liver function test abnormal; Oedema peripheral; Pain; Pleural effusion; Pruritus; Skin nodule; Urticaria; Viral infection	FLU3~MEDEVA PHARMA, LTD.~E71300LA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0167686	03/22/2001	KY	4.0	4		M	01/25/2001	The pt developed a temp of 103.2. The pt's mother gave him Tylenol prior to school in the AM.									Y	01/23/2001	01/24/2001	1		PUB	PUB	Digoxin, Lasix, Coumadin,		hypo-plastic left heart syndrome		KY2001005	1						1	Pyrexia	FLU3~AVENTIS PASTEUR~U0443AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~474728~1~IM~LA~PNEUMO (PREVNAR)~1	USA		Influenza
0167704	03/23/2001	PA	80.0	80		M	03/19/2001	This patient was admitted to the hospital on 11/01/00 and died on 11/12/00. The patient was examined and given a flu shot on 11/01/00, he had shortness of breath and sore legs, so the doctor wanted to do a CXR, R-Tibia X-ray, and a EKG. His diagnosis was osteoporosis. The patient was taken to the ER on 11/01/00 at 10 PM because he had terrible tremors, fever, weakness, and nausea. The patient was immediately admitted to the hospital and he told the doctor of his flu shot the doctor said he had a mild heart attack, had a high fever, and there appeared to be an infection in his lungs. The patient had two previous bouts with pneumonia treated with antibiotics an no lung problems since then. The patient was put in the ICU on a respirator. Saw an infectious disease doctor who focused on his right leg because she thought there might be an infection but there was no sign of infection. The patient was eventually put in telemetry on the 8th floor. He had a monitor that would show signs of a heart attack at the nurses station. His fever was still high and the wife was told they would watch her husband to make sure the fever goes down but there were no cold blankets, no ice packs. He was on a nose device for oxygen. The wife and friends observed a lack of activity in looking in on the patient. By Sat. there was no news as to the infection or the fever. On Sat. night the patient spent time with his wife had two visitors who thought he was bloated, he was weak, when he went to the bathroom. Prior to his trip to the bathroom the wife noticed that he did not have his oxygen nose piece in. It was carefully wrapped and hanging in the back of the patient's bed. The patient said they took it off. That evening when the wife left she asked for the nurses to help and look in on her husband because he was weak and could fall and hurt himself. That evening about 8:30 PM the wife received a phone call her husband took a turn for the worse and was being put back on a respirator and back into ICU. When she arrived she was not able to see her husband until 10:30 PM, three nurses assured her that he had been in the bathroom and had an attack, while they were with him. A female resident told the wife she had to put a tube down his throat because he could not breathe. The next three days were critical (the doctor said the next 24 hours). The patient was very weak, his kidney were slowing. By Thursday he improved and the respirator was removed. They were going to test him, he was put in a chair and strapped; he swallowed soft items; he was at first disoriented (ICU psychosis) as the nurses and doctors put it. He then wanted water and said his throat hurt. He was moved back to Telemetry on Friday afternoon was alert and talking. The doctors were told again of the patient's recent flu shot before his attack and the doctors could not believe it. They were more concerned with the patient lungs than his heart. The doctor told the wife that the patient had congestive heart failure and sometimes a bigger attack occurs after a small one. The family never knew of his congestive heart failure. To the family's knowledge he was not ordered to curtail some heavy activities.  The patient was put on an ice blanket because the fever was up. The wife requested for his move back up to the 8th floor that her husband be put across from the nurses station and not at the end of the hall, the doctor noted that.  The wife asked why he was being taken off from the monitor so fast. The patient was still weak, he could not move his arms, his speech was weak. About 9 PM on Saturday the patient's sugar was high 300+. He needed insulin, and his wife requested that they make sure he sipped some ensure or he would bottom out. The wife was worried about her husband at this point a nurse had said he was very sick so she requested to speak with the doctor in the morning (Sunday) and reminded the nurses he had a living will on file. The patient told his wife she'd better go it was getting late and that was the last time she saw her husband alive. She received a call at approximately 3 AM that he had taken a turn for the worse, same night, same staff, same floor as the previous week. The wife reminded the nurse of the living will. When she arrived at the door of her husbands room she found 25 people in the room with paddles, pumps, respirators, electronic shocks. She screamed at the same resident from the previous week that she should have know better, that they had talked. She asked why they had put her husband through that when she talked about this very thing with the nurses around 10 PM that night. The resident said oh you didn't want us to do it, she then turned around went back into the room and told everyone to stop. The resident told the wife that her husband was not breathing and they did everything to revive him. The wife stated that this is not what her husband wanted and asked everyone in the room how would they feel if it was their son or husband. The husband was dead and the wife had several questions.	Y	11/12/2000							N	11/01/2000	11/01/2000	0		UNK	UNK			Cancer, heart attack 1999, Cataract surgery 2000, pneumonia 2x.			1						1	Abdominal distension; Apnoea; Asthenia; Blood glucose increased; Cardiac failure congestive; Disorientation; Dyspnoea; Hypoxia; Infection; Movement disorder; Myocardial infarction; Nausea; Osteoporosis; Pain; Pharyngolaryngeal pain; Pneumonia; Psychotic disorder; Pyrexia; Speech disorder; Tremor	FLU3~MEDEVA PHARMA, LTD.~E6562CHA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0167729	03/23/2001	CA	31.0	31		M	03/14/2001	Left shoulder pain, post vax. Arthus reaction the next day on 11/21/00. Treated with heat and elevation.				Y					U	11/20/2000	11/21/2000	1		PVT	PVT	albuterol oral inhaler and insulin		DM			1						1	Pain; Type III immune complex mediated reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1611H~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0167753	03/26/2001	MA				M	03/21/2001	A physician reported that an adult male in his late 30's received an injection of Flu-Sheild (1999-2000 formula) in the fall of 1999. Within 1 week post-immunization, he developed cryoglobulinemia and vasculitis. He was hospitalized. Unspecified tissue biopsies are pending. No further information was available at the date of this report.					Y				U				Unspecified tissue biopsies-pending	OTH	OTH	UNK	UNK	UNK		HQ8678121MAR2001	1						1	Blood disorder; Vasculitis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0167788	03/26/2001	UT	26.0	26		F	12/20/2000	12/15/00 at 17:30, left arm was immovable, soreness and aching muscle pull type pain. Under left arm was tender. Started running a fever, chilling (significant) at 23:00. On awakening on 12/16/00 AM, continued with sore arm, felt warm with fever, shaky, tingly all over inside, chills again at 20:00, lasting all night. Sunday AM, took temperature and it was 102.9F (ear). Took Tylenol and Advil and fever decreased. Saw MD on 12/17/00 and started on prednisone.				Y					Y	12/15/2000	12/15/2000	0	NONE	PUB	PUB	Methylprednisolone started after 12/20/00	NONE	NONE		UT002729	1						1	Feeling hot; Hypokinesia; Injection site pain; Myalgia; Pyrexia; Tremor	FLU3~PFIZER\WYETH~4008202~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0690K~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~CONNAUGHT LABORATORIES~U0330AA~7+~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0167789	03/26/2001	SC	60.0	60		F	03/19/2001	Hives treated with prednisone 10mg Tabs/took 2 (48) packs before the hives were completely gone. First round of medicine did not rid pt of hives.									Y	11/29/2000	12/02/2000	3		PUB	PVT		NONE	NONE			1						1	Urticaria	FLU3~AVENTIS PASTEUR~U0439D9~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0167790	03/26/2001	CA	52.0	51		F	03/09/2001	Per pt, developed cellulitis of the right deltoid area; 2 days, post vax. Was placed on 2 antibiotics (Keflex and Biaxin) and Prednisone, per pt.				Y					Y	02/13/2001	02/15/2001	2		PUB	OTH	UNK	NONE	NONE			1						1	Cellulitis; Injection site reaction	FLU3~AVENTIS PASTEUR~U0405AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0721K~UNK~IM~LA~HEP B (RECOMBIVAX HB)~1|HEPA~SMITHKLINE BEECHAM~671A4~UNK~IM~RA~HEP A (HAVRIX)~1|PPV~PFIZER\WYETH~468136~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~U0316AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0165835	03/27/2001	PA	73.0	72		M	01/26/2001	Pt was seen in clinic on 12/14/00 with some pain and swelling on left deltoid. Pt was seen again on 1/25/01 with severe pain in the left deltoid area. Pt complained of needle-like feeling and an irregularity in one area. Pt is going to physical therapy also.				Y					U	12/01/2000	12/14/2000	13		PVT	OTH	Albuterol, Lopressor, beclomethasone, alendronate	NONE				1						2	Injection site pain; Injection site swelling; Paraesthesia; Injection site pain; Injection site swelling; Paraesthesia	FLU3~MEDEVA PHARMA, LTD.~E67400RA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~MEDEVA PHARMA, LTD.~E67400KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0167859	03/27/2001	NC	55.0	55		F	12/06/2000	On 12/6/00, red, swollen and hot area, with temperature of 100.3F. Has nausea and feels bad. Treated with Keflex. On 12/13/00, pt doing well.				Y					Y	12/04/2000	12/05/2000	1		PUB	OTH	BP med and hormone	NONE	Allergic to sulfa		NC01036	1						1	Feeling abnormal; Injection site erythema; Injection site swelling; Injection site warmth; Nausea; Pyrexia	FLU3~PFIZER\WYETH~4008188~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0946K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0168004	03/30/2001	MD	81.0	79		F		Both arms are painful and weakened at shoulder and top.  Pt is undergoing therapy.									Y	12/01/1999				PUB	UNK						1						1	Muscular weakness; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0168005	03/30/2001	VA	34.0	34		F	03/08/2001	The pt felt weak, hot and short of breath, numbness in the hands and feet. Shallow breathing, O2 given. Pt cold and shaking. Epipen given IM. Paramedics came at 11:00 am. EKG normal, pt calming down. 12:00 pt was relaxed and asleep.									Y	01/19/2001	01/19/2001	0		PVT	PVT	Nystatin, Diflucan, Thyroid					1						1	Asthenia; Dyspnoea; Feeling hot; Hypoaesthesia; Hypoventilation; Hypoxia; Tremor	FLU3~PFIZER\WYETH~4008230~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0163757	04/02/2001	WI	3.0	3		M	02/27/2001	A territory representative reported that a pt received an injection of Prevnar and subsequently, developed an injection site reaction characterized by hives and swelling. No further information was available at the date of this report. This is 1 of 4 pts from this facility who had an adverse experience following receipt of Prevnar lot 471231. The reporter was unable to specify the number of pts who experienced this event. Reports will be generated when identifying information is provided. Follow-up received on 2/21/01 from the physician, indicated that a 3 year old male received Prevnar and Flu Shield '00-'01 formula on 12/6/00. The following day, the child developed an injection site reaction characterized by a 6cm by 4cm area of hives, swelling, redness, warmth and induration at the site of Prevnar administration.									U	12/06/2000	12/07/2000	1	UNK	PVT	PVT	UNK	NONE	UNK		HQ4860814DEC2000	1						2	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth; Urticaria	FLU3~PFIZER\WYETH~4002121~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PNC~PFIZER\WYETH~471231~1~IM~RA~PNEUMO (PREVNAR)~2	USA		Influenza
0168021	04/02/2001	WV	53.0	53		M	03/07/2001	This patient lost sight in his left eye. (Nothing else attached).     The follow up received on 7/3/01 states, this is a 53 year old pt who was referred by Dr, to try to help me. I'm losing my vision; I basically lost my vision in my left eye. I first noticed the loss of vision on January 5, I took the flu shot about 2:00 in the afternoon, and about 7:30 or 8:00, I went down to read a book and it was fuzzy. He checked the eyes individually and found that the fuzziness was only OS. When he awoke the next morning, it was still fuzzy. The same morning, Saturday, January 6, he was seen by Dr, an optometrist. She basically said I needed to go see an ophthalmologist. It sounds like he was told that he had AION. On Monday, January 8, he was seen by Dr and he basically told me I had the same problem but he wanted to go ahead and run various blood tests and an MRI. The MRI scan was done on January 9. It was all good except he had sinusitis. I didn't have any vision in the upper half. This past Sunday (1/14), it started in the lower half, and since then it's just about to the point where it's all gone. There is a mild swelling-like or puffy-like sensation. There has been no real pain; no pain on motility. In driving down here yesterday, there was a lot of strain on it. It just feels like your eye is weak, it's worn out, you just want to close it. There has been no problem with vision OD. He has had some mild hypertension. It's high when I first have it tested, but by the time I leave the office, it's down to around 140/90. Four days ago he was started on Norvasc. There is no history of diabetes, ASCVD, angina, MI, CVA, focal motor weakness, or cigarette consumption. He has been on Decadron for 2 years for Meniere's disease. There was no prior MRI scan.								Y	N	01/05/2001	01/05/2001	0		OTH	UNK						1						1	Blindness	FLU3~PFIZER\WYETH~4008181~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0168026	04/02/2001	AR	55.0	55		F	01/17/2001	This patient received the flu shot on 12/20/00. No elevated discomfort at the time of the injection. Within 24 hours, the patient experienced alot of discomfort in the deltoid to elbow region. Discomfort limits range of motion at times. The patient did not have fever at anytime, but discomfort persists. The patient took Tylenol one time with some measure of relief. No redness or induration noted  at the left deltoid area. The patient referred to the PMD for evaluation.				Y					U	12/20/2000	12/21/2000	1	Pending MD visit.	OTH	PUB	HRT	NONE	Hep C		AR1801	1						1	Hypokinesia; Pain	FLU3~AVENTIS PASTEUR~UO447AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0168027	04/02/2001	IA	73.0	72		M	03/15/2001	This patient received a flu shot on 12/28/00. He presented 01/22/01 to the clinic with history of 4 weeks of left arm edema which started after the flu shot. He had edema in the arm after the flu shot 2 years prior but also cleared on its own. This time it didn't. He underwent CT Scan, and venogram to r/o DVT or a mass effect causing lymphadenoma; all were negative. Arm still very swollen.									N	12/28/2000	12/30/2000	2	Thoracic CT, Left arm venogram, - All Neg.	PVT	PVT	Prevacid, Synthroid, Catapress, Bumex, Wellbutrin, Lotensin, ASA, Paxil, Norvasc, Combivent		Allergic to Penicillin, Sulfa, Cipro, Morphine, Ceclor. Diabetic type II, Hypothyroidism, CAD, COPD, Diabetic neuropathy, BPH, Hypertension, Hiatal hernia, depression / anxiety, Paroxysmal atrial fibrillation, CHF-stable, Nephrosclerosis, S/P AAA repair, DVT, PE, CABG, umbilical hernia repair, Cholecystectomy, Small bowel obstruction, GI bleed.			1						1	Lymphadenopathy; Oedema	FLU3~AVENTIS PASTEUR~UO445CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0168028	04/02/2001	MI	21.0	21		F	12/06/2000	Severe Pain at the injection site on the left arm. The arm was warm to touch. Vitals were taken at 1:45 PM as followed Temp 97.4, P 84, R 16, B/P 72/60. On 12/11/00, per phone call; the patient complained of generalized swelling of the upper arm. On 12/06/00 she had a temp of 101 F for 2 days with pain at the injection site. On 12/05/00 she had itching for 1 1/2 days after the injection. No additional medical follow up. Treatment of cool compresses and Ibuprofen taken by the patient. Presently feeling much better. Enc medical care if needed. In later October 2000, the patient was diagnosed and hospitalized with Influenza. Complained of weakness, elevated temp, and a sore throat. Treated with antibiotics names unknown.									Y	12/05/2000	12/05/2000	0		PUB	PUB	Prednisone		Congenital adrenal hyperplasia, allergy to acetaminophen and Penicillin.	no data~Influenza (Seasonal) (no brand name)~1~21.00~In Patient	MI2001021	1						1	Asthenia; Hypotension; Influenza; Injection site pain; Oedema; Pharyngolaryngeal pain; Pruritus; Pyrexia	FLU3~PFIZER\WYETH~4008193~1~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0168088	04/02/2001	MD	1.25	2	.3	F	03/16/2001	A nurse reported that a 15 month old female received her 1st injection of Prevnar and Fluzone vaccines on 12/4/00. Later that day, the child developed an injection site reaction characterized by bruising and pain upon touching. Two days later, the child experienced viral syndrome with diarrhea and a fever of 102.5F. This report is 1 of 3 cases of injection site reactions secondary to the same lot of Prevnar reported from the same institution. See case ID #'s HQ4692111DEC2000 and HQ6902606FEB2001 for the reports on the other cases. Follow-up information received on 3/5/01 revealed the child was not receiving concomitant medications.									U	12/04/2000	12/06/2000	2	12/06/2000-Fever 102.5F	PVT	PVT	UNK	NONE	UNK		HQ6902506FEB2001	1						1	Contusion; Diarrhoea; Injection site pain; Injection site reaction; Pyrexia; Viral infection	FLU3~AVENTIS PASTEUR~U0435AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~473812~1~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0165304	04/03/2001	MD	73.0	73		F	03/29/2001	Information has been received from a physician concerning a 73 year old female pt who on 12/13/00 had vaccines. On 12/16/00 or 12/18/01, the pt experienced ascending paralysis consistent with Guillain-Barre'. Follow-up information has been received which reports the pt was hospitalized from 12/18/00 to 2/14/01 and had complications of aspiration pneumonia, SIADH and a UTI. It was noted that a LP was done which showed a CSF protein 71 and WBC 1. The pt was in a rehab facility. At the time of the report, 3/20/00, the events were considered to be immediately life threatening, disabling and Other Significant Medical Event by the reporter. The outcome was unknown. Follow-up received from a health care provider which states that as of the last doctor visit on 4/9/01, she had recovered from her experience. The pt completed rehabilitation, was functioning well and was able to perform all activities of daily living. It was reported that the only vaccine the health care provider saw reference to, was the flu vaccine. He states he could not definitely state whether or not the pt ever received pneumococcal vaccine 23 polyvalen. He also reported that he did not know if the pt's experieces were even related to her vaccines. The pt's experiences were considered to be immediately life-threatening, disabling and Other Significant Medical Events by the reporter. F/U info rec'd on 4/17/01 indicated that the pt recovered.			Y	Y	Y	58	Y	Y	Y	12/13/2000	12/16/2000	3	EMG and electrophoresis protein were positive and noted to be consistent with Guillain-Barre'; CSF-protein 71 (+) and 1 WBC	PUB	PUB	Norvasc, Arthrotec, Prevacid		Hypertension; allergy to PCN and sulfa		WAES01012522	1						3	Guillain-Barre syndrome; Paralysis; CSF test abnormal; Guillain-Barre syndrome; Hypoxia; Laboratory test abnormal; Paralysis; Antidiuretic hormone abnormality; CSF test abnormal; Guillain-Barre syndrome; Laboratory test abnormal; Paralysis; Paralysis flaccid; Pneumonia; Urinary tract infection	FLU3~PFIZER\WYETH~4008195~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1070K~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~PFIZER\WYETH~4008195~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~MERCK & CO. INC.~1070K~1~IM~RA~PNEUMO (PNEUMOVAX)~2|FLU3~PFIZER\WYETH~4008195~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~3|PPV~MERCK & CO. INC.~1070K~1~IM~RA~PNEUMO (PNEUMOVAX)~3	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0168255	04/04/2001	NY	70.0	70		M	03/26/2001	On 11/09/00, the patient had a flu vaccine. On 12/27/00, the patient had tingling and prickly feeling in his hands and feet. On 12/28/00, the patient went to the doctors office with decreased feeling in his feet. He made an appt to see the neurologist on 01/02. On 12/29/00, the patient had difficulty waking, with decreased feeling in his legs and feet, and loosing balance. On 12/30/00, the patient called the doctor because loss of sensation was progressing up his legs, arms, and hands. He had difficulty sleeping because of discomfort. 12/31/00, the patient had numbness progressing in his thighs to his hips. The doctor sent him to the ER where he was seen by a neurologist. He was sent for an MRI and return was admission to ICU. On 01/05/01, the patient improved some and was discharged. He was able to use the walker with difficulty. He was evaluated by PT. He had therapy on 01/15,01/18, 01/22 and 01/25, condition declining, he was getting weaker. 01/16/01, More medication was ordered to be given at home for 3 days, an RN came to the house and stayed during treatment. 01/20/01, he felt a little improved. 01/22 & 01/25/00, the patient had PT. 01/26/01, his condition was worse, unable to go upstairs, or walk with a walker without falling. On 01/30/01, he saw a neurologist and was taken to the ER and was admitted and evaluated by referring doctor. The patient was given plasma phoresis prescription on 02/01, 02/02, 02/03, 02/04, 02/05, and 02/07. He had a nerve testing on 02/11 no improvement. On 02/12/00, he was transferred to another hospital via w/ch van for rehab. He had 1 hour of PT in the AM and 1 hour of OT in the PM. The patient's condition continued to decline. His appetite was poor, he had difficulty swallowing, weight decreased, because he became weaker each day, not eating. 02/20/01, The doctor was notified and the patient was transferred back to the ICU at the original hospital. On 02/21/01, more meds and had a nasogastric tube inserted for feeding.  His weight declined from 175 - 137. Still no movement in his legs, moving fingers; continued to improve. On 02/28/01, the patient was transferred out of ICU to a floor unit. He was moving his hands and his arms; able to hold a newspaper. On 03/01/01, doing better, getting OT & PT. Still NPO. Test showed inversion of epiglottis. On 03/02/01, moving arms, able to make a fist, NG tube out and stomach tube inserted via abdomen, sleeping poorly, breathing test improving. On 03/06/01, very lethargic, slept most of the day. 03/08/01, depressed,  complains of weakness of arms and legs. Had a sonogram of his leg. 03/09 and 03/10/01 more meds, moving his fingers a little, voice seems stronger.03/11/01, felt like increased strength in his right arm. 03/12/01, he was moving his arms and legs, and able to reach nose. Breathing test 2.6 + 60, chest clear. 03/13/01, weight down to 122, more meds, able to move arm back and forth on tray table (PT).  03/14/01, good spirits, able to move arms and legs but no real control. 03/23/01, patient went home, improving but still unsteady, moving arms and hands, legs still very flaccid. Diagnosed with GBS.			Y	Y	Y	59	Y	Y	N	11/09/2000	12/27/2000	48	MRI; Spinal Tap; Cat Scan of abdomen; Nerve biopsy; Blood work; Doppler of legs-no clots; Colonoscopy-polyps; 24 hour UA	OTH	UNK	NONE	NONE				1						1	Anorexia; Asthenia; Balance disorder; Depression; Difficulty in walking; Dysphagia; Guillain-Barre syndrome; Hypoaesthesia; Hypotonia; Insomnia; Lethargy; Paraesthesia; Weight decreased	FLU3~AVENTIS PASTEUR~U0415AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0168256	04/04/2001	TX	64.0	63		F	03/26/2001	He was having breathing problems, bronchitis and developed influenza on 11/17/00, 1 month, post vax. Still sick but doing better as of 3/27/01. 60 day follow-up states the pt still has a slight cough and bronchitis.  Follow up:  MD's office had no further information.			Y						Y	10/16/2000	11/17/2000	32		PVT	OTH		NONE				1						1	Bronchitis; Cough; Dyspnoea; Influenza	FLU3~SANOFI PASTEUR~U0684AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0168258	04/04/2001	OH	41.0	41		F		Transverse Myelitis; Over a few days, pt developed complete plegia of legs and sensory level at T2 with bladder and bowel incontinence. This has persisted. Pt also has persistent pain at site of injection. Rash. Able to do self care. Stimulation only was walker in house. Wheelchair when goes out. Tired easily. Transverse myelitis.				Y				Y	N	11/20/2000	11/21/2000	1	MRI of T-spine; MRI brain; Wasting from T2 to T4	UNK	UNK	NONE	NONE	NONE			1						1	Cachexia; Faecal incontinence; Injection site pain; Myelitis transverse; Paraplegia; Urinary incontinence; Myelitis transverse; Paralysis	FLU3~AVENTIS PASTEUR~U0335AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~AVENTIS PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Disabling	Influenza
0168298	04/04/2001	MT	56.0	56		F		1 or 2 days, post vax, had very bad muscle pain in left arm at shoulder radiating down to elbow and under arm, causing pain, tingling and numbness. Could not lift arm without using right arm for support. Pain has become less severe since February, but is still there. Took  much Advil and got cortisone shot in shoulder on 1/12/01, but did not help.									U	11/03/2000	11/05/2000	2		PVT	PVT	NONE	NONE	NONE			1						1	Hypoaesthesia; Hypokinesia; Myalgia	FLU3~AVENTIS PASTEUR~U0400AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0166781	04/06/2001	WI	14.0	14		M	01/16/2001	Pt received the vaccines and several minutes later, he became diaphoretic, flushed, complained of light-headedness and some tightness in his chest. BP-128/68; P-88. After about 10 minutes, BP-120/60 and P-80. The flushing and diaphoresis diminished. Per telephone call, the father reports that the pt has a lump at the sight of left arm where the pneumonia shot was given. On 1/29/01, talked with parent and the allergist was very concerned about the reaction after the shots because he was thinking that the reaction could be a response to thermerisol or gelatin. He has suggested that the pt get all of his future vaccinations at this doctor's clinic and not even at another MD's office and they could then monitor him more closely. He has a follow-up appt in 6 months. The mother also feels that the pt has had more minor asthma attacks that require his inhaler use since the flu and pneumonia vaccines were given.									Y	01/15/2001	01/15/2001	0		PUB	PUB	Albuterol; Singulair; Flovent	NONE	Asthma; Many allergies (dust, mold, foods (primarily)		WI0115	1						2	Chest discomfort; Dizziness; Flushing; Hyperhidrosis; Asthma; Blood pressure increased; Chest discomfort; Dizziness; Flushing; Hyperhidrosis; Injection site mass	FLU3~PFIZER\WYETH~4008197~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0690K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~PFIZER\WYETH~4008197~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~MERCK & CO. INC.~0690K~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0168382	04/06/2001		2.0	3		F	03/05/2001	Approx. 24 hours, post vax, the pt had an unprovoked, brief syncopal episode. She recovered fully. Work-up of episode has produced no etiology. (Syncope occurred at daycare in the AM of 2/21/01).				Y					Y	02/20/2001	02/21/2001	1	Vital signs-nml; no fever; electrolytes (serum); EKG; CBC; UA-all WNL	MIL	MIL		Resolving RAD-flare (mild)	Reactive Airway Disease; recurrent otitis media			1						1	Syncope	FLU3~PFIZER\WYETH~4008210~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0168383	04/06/2001	WI	58.0	58		M	01/16/2001	States in mid December and same last year; began with macular scattered rash on entire arms, posterior popliteal to calves and lateral abdomen. Changes to papular; pruritic; open after scratched. No fever. Ruhuli gel decreases pruritus. On 2/1/01, saw MD and was put on prednisone.									Y	12/11/2000	12/13/2000	2		PUB	PUB	NONE	NONE	NONE		WI0119	1						1	Pruritus; Rash maculo-papular	FLU3~PFIZER\WYETH~4008207~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0168398	04/06/2001	IL	1.0	0	.6	F		Had febrile seizure, fevers, cyanosis after seizure which quickly resolved.				Y					Y	11/28/2000	11/30/2000	2	Blood culture-(-)	PVT	UNK	Synagis	Viral URI	Congenital heart disease with pulmonary stenosis and IVSD.			1						1	Cyanosis; Febrile convulsion	FLU3~SANOFI PASTEUR~W0114BB~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1266K~2~IM~~HEP B (RECOMBIVAX HB)~1|IPV~CONNAUGHT LTD.~T03952~3~IM~~POLIO VIRUS, INACT. (POLIOVAX)~1	USA	Emergency room visit	Influenza
0164584	04/09/2001	WV	40.0	40		M	12/06/2000	Pt stated that the next day, post vax, he developed generalized rash with intense itching and was treated at local ER and given prednisone and Benadryl. The doctor stated the rash was from the flu shot, not Levoquin. Rash and itching was all gone in 24 hours.				Y					Y	11/30/2000	12/01/2000	1	Blood work	OTH	PVT	Levaquin started 14 days prior	NONE	NONE		WV0101	1						2	Pruritus; Rash; Hypersensitivity; Pruritus; Rash	FLU3~AVENTIS PASTEUR~U0441AA~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~AVENTIS PASTEUR~U0441AA~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0168483	04/10/2001	OK	52.0	52		F	02/05/2001	The pt reports left arm swelling, redness with streaks after receiving vaccination. The pt went to the ER for treatment on 1/20/01. the pt was treated with antibiotics.			Y						Y	01/18/2001	01/18/2001	0		PUB	PUB	Synthroid, Claritin, Vioxx, Premarin, Prevacid	NONE	bronchial infections and sinusitis		OK0107	1						1	Injection site erythema; Injection site oedema; Skin striae	FLU3~PFIZER\WYETH~4008205~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0690K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening	Influenza
0168576	04/11/2001	OK	30.0	30		F	02/07/2001	The following day after her injection, the patient experienced red welts from neck down to her feet, all over her body. Still present this day. The doctor prescribed Prednisone for 2 weeks with no relief. Taking UV treatments, erythromycin, biopsy of welts with diagnosis of Pityriasis Lichenoi'des Acu'ta. Possible chemotherapy in the future.				Y					N	12/11/2000	12/12/2000	1	Biopsy of welts.	OTH	PVT	Orthocyclen B/C pills	NONE	Allergic to Codeine, Penicillin, Tetracycline, All childhood immunizations.		OK0109	1						1	Erythema; Lichenoid keratosis; Skin disorder; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0168631	04/12/2001	NY	35.0			F	04/10/2001	The pt experienced severe pain, swelling, redness at the site of injection 2 days post vax. A 7cm round area to the right deltoid was warm to the touch and swollen. The pt was treated with Benadryl, Motrin and Atarax.									U	02/01/2001	02/03/2001	2		UNK	UNK			allergy to tetracycline, aspirin, cefaclor			1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0168666	04/13/2001	NY	35.0			F	04/10/2001	Pt had severe pain, swelling and redness at injection site, 2 days, post vax. Had 7cm round area of right deltoid and was warm to touch and swollen. Treated with Benadryl po, Atarax po and Motrin po.				Y					U	02/01/2001	02/03/2001	2		UNK	UNK			Allergies to tetracycline/aspirin/cefaclor.			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0168667	04/13/2001	TX	48.0	48		F	01/31/2001	On 1/26/01, approx 10:00, throat started hurting, coughing and head hurting. On 1/27/01, states she had a fever but does not know how much. On 1/28/01, states she had a fever, chest and back was hurting she went to ER but she was not told how much fever. In ER, she had blood work x-rays done. ER doctor told her results were all ok. Told her probably virus and to go home and to recheck with her doctor in the morning. On 1/29/01, she went to MD and he told her it could be attributed to flu shot. Gave A/B for 3 weeks and gave shot and told her more like sinus infection. Please note that she has had the flu shot in previous years with no reaction.				Y					U	01/25/2001	01/26/2001	1	? blood work and x-ray. Stated ER told her everything ok and was possibly a virus.	PUB	PUB			Known to have sinus and allergy problems.		TX01010	1						1	Back pain; Chest pain; Cough; Headache; Pharyngolaryngeal pain; Pyrexia; Sinusitis; Viral infection	FLU3~PFIZER\WYETH~4008198~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0168757	04/17/2001	MO	62.0	61		F	04/11/2001	This patient had respiratory porplysis with Guillain Barre' Syndrome. The follow-up states that the pt's legs from her knees down and her feet are still numb. She has trouble wearing shoes and she states that it's very painful. Doc 212822, annual follow up, states numbness in feet and up front of legs, weakness in legs.			Y		Y				N	11/18/2000	11/19/2000	1		PVT	OTH		Angina,GERD, Hyperlipodemia				1						1	Guillain-Barre syndrome; Hypoaesthesia; Muscular weakness; Pain; Respiratory disorder	FLU3~PFIZER\WYETH~4008213~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0168772	04/17/2001	WA	49.0	49		F	03/06/2001	This patient had a headache 11/14 thru 11/18, urinary incontinence, depth perception problems, and visual blurring.									U	10/16/2000	11/14/2000	29	Neurology/ Ophthalmology evaluations, MRI of the brain.	MIL	MIL	NONE	NONE	Class I latex allergy. Allergic to Septra and Copalite.		WA011731	1						1	Eye disorder; Headache; Urinary incontinence; Vision blurred	FLU3~MEDEVA PHARMA, LTD.~E58510FA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0168853	04/18/2001	CA	3.0	2	.7	M	04/03/2001	Warmth, edema, erythema at injection site on left deltoid; induration and pain less than 24 hours, post vax.				Y					Y	12/14/2000	12/15/2000	1	NONE	PVT	UNK						1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site pain; Injection site warmth	FLU3~PFIZER\WYETH~4008196~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0168895	04/19/2001	MN	56.0	56		F	04/09/2001	I had full body aching as severe as I've ever had, with no other symptoms of the flu. This lasted 2 days.									Y	11/24/2000	11/25/2000	1		PVT	PVT		NONE				1						1	Pain	FLU3~PFIZER\WYETH~4008117~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0165569	04/20/2001	CA	74.0	74		M	04/16/2001	This patient had acute pain in his left arm, neck, head,both shoulders, slight bruising, and a fever. Went to the ER 11/10/00, twice. His throat was swelling shut he couldn't open his mouth. Any movement became very painful. Weekly CBC's, UA, Blood platelets given. Each pain occurrence his left arm swelled and he had acute pain, and fever. In January he had a bone marrow test that showed early myeloid leukemia. The patient is usually hard working around the house but the back pain kept him limited for about a year. Since the time he suffered intense pain most of the time, lost appetite, been anemic. he seemed to be getting much weaker, his legs refuse to hold him up at times, he shakes a lot, and even sunk down to the floor the other night while going tot he bathroom and had to have the fire dept pick him up. His head and scalp have been extremely tender to touch the entire time. When he wasn't feeling well he often didn't think well, remember, or talk well. This is probably lack of oxygen in his blood they say. He had transfusions about every 2 weeks, until the last blood test or so, and no one said anything. 02/12/01, after 3 1/2 weeks without blood transfusions, he developed severe pain in that arm and into his chest, fever, etc. and was taken to the hospital ER by ambulance. Twelve hours after his wife's admonition to please check his blood, they found fever and low blood (red cells and platelets) and admitted him. Again his arm was swollen up and he was put on IV antibiotics, blood platelets, etc. He was kept in the hospital for 8 days. He finally was sent home under hospice care. They checked him over and said he might not last through the night. That was 02/21/01. He lingered until the evening of 02/23/01, when he died. He felt strongly that the flu shot caused or accelerated the leukemia. It caused him a great deal of pain. Each time he got bad his arm swelled and was excruciating for him.	Y	02/23/2001	Y	Y	Y	14			N	11/08/2000	11/09/2000	1	CBC 11/11/00. Low Platelets, anemia (normal CBC 2 mos earlier.) Bone marrow test 01/11/00- showed myelodysplasia or evolving AML.	PUB	UNK	Atrovent, Altace, Pravochol, Azmacort, Valium, Tylenol with Codeine.	NONE	Asthma, ASHD, Arthritis. Had one heart bypass. Back surgery decompressive laminectomy L2-3 for spinal stenosis (10/03/00).			1						3	Arthralgia; Headache; Injection site haemorrhage; Injection site pain; Neck pain; Anaemia; Contusion; Difficulty in walking; Dysphagia; Fatigue; Headache; Injection site pain; Leukaemia; Memory impairment; Neck pain; Pain; Pharyngeal oedema; Platelet count decreased; Speech disorder; Syncope; Thinking abnormal; Tremor; Weight decreased; Anaemia; Anorexia; Blood disorder; Chest pain; Headache; Hypokinesia; Hypoxia; Malaise; Memory impairment; Myeloid leukaemia; Neck pain; Oedema; Pain; Pharyngeal oedema; Platelet count decreased; Pyrexia; Speech disorder; Tremor	FLU3~MEDEVA PHARMA, LTD.~E67330KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLU3~MEDEVA PHARMA, LTD.~E67330KA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~3	USA	Results in Death	Influenza
0166219	04/24/2001	PA	19.0			U		This patient had transverse myelitis, onset. Prescribed a 5 day burst of IV steroids, and oral steroids.				Y	Y				U	11/22/2000			MRI's; Spinal Taps; Blood work	OTH	PVT		NONE	Attention Deficit.			1						2	Myelitis transverse; Myelitis transverse	FLU3~AVENTIS PASTEUR~U0335AB~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~AVENTIS PASTEUR~U0335AB~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0168988	04/24/2001	FL	76.0	76		M	03/20/2001	Pt broke out in a rash on 12/21/00. Started on ankle area and then spread to rest of body. Rash is red, itchy, flat, and round areas, sometimes ooze. Clears some and then returns. Went to MD and then referred to dermatologist and may see allergist. Still has rash.				Y					N	12/13/2000	12/21/2000	8	Biopsies-neg	PUB	PUB	Lopressor					1						1	Erythema; Pruritus; Rash vesicular	FLU3~AVENTIS PASTEUR~U0441AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0168989	04/24/2001	PR	49.0	49		F	02/22/2001	Noted around injection site; redness, erythema, inflammation and general weakness.									N	02/13/2001	02/13/2001	0	NONE	PUB	PUB	Vasotec	NONE	Hypertension			1						1	Asthenia; Erythema; Injection site erythema; Injection site inflammation	FLU3~PFIZER\WYETH~408227~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0169030	04/25/2001	NH	19.0	19		M	04/18/2001	Impaired memory/cognition, constant headache since 1/4/00; chest pains; 3 syncopal episodes (totaled car) (lost license), fatigue, personality change, episodes of disorientation with abnormal EEG; episodic atrial fibrillation and pool balance.  Follow up report on 09/07/2001: As of 08/31/2001, his status is unchanged.			Y						N	01/04/2000	01/04/2000	0	PCPK and troponin/no cardiac cath; EEG-abn (episodic atrial fibrillation)	MIL	MIL	NONE	NONE	NONE			1						1	Atrial fibrillation; Chest pain; Disorientation; Electroencephalogram abnormal; Fatigue; Headache; Histrionic personality disorder; Memory impairment; Syncope	ANTH~EMERGENT BIOSOLUTIONS~~1~SC~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~1~IM~~HEP B (NO BRAND NAME)~1|JEVX~UNKNOWN MANUFACTURER~~1~SC~~JAPANESE ENCEPHALITIS (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~IM~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0169084	04/25/2001	NM	56.0	56		F	03/02/2001	Swelling and pain at left tricep/deltoid region. Pt complained of debilitating pain and discomfort. Has seen PCP twice and Rx'd with muscle relaxer and anti-inflammatory medication with little or no relief. Has appt with physician next week.				Y					U	12/20/2000	12/21/2000	1		PUB	PUB	Hormones	NONE			NM030002	1						1	Injection site pain; Injection site swelling	FLU3~PFIZER\WYETH~4008220~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0169085	04/25/2001	OH	49.0	49		F	03/07/2001	Pt received flu shot on 12/18/00. She notified me approx. 5 hours later, that she was having shooting pains up and down her arm. I told her to use Tylenol and ice. (Per her account, she was at the tail end of a 2 week cold and was feeling good and had no temperature.) The shooting pains progressed and radiated to her sternum by the  following day. The pain worsened, but was off and on until she sought medical care on 12/28/00. The ER doctor told her he had seen several cases of people getting this reaction after the flu shot following an infection. Her 2nd ER visit was on 1/3/01 with pain intensified in left arm and left chest and sweating. She was treated with Toprol and Vioxx but was discontinued. She was put on Xanax and Paxil. She was transferred to another hospital. After tests, she was released after 24 hours with no cardiac problems detected. She had a few faint spells and was tired. On 1/15/01 to 1/21/01 she had heavy bleeding and large clots on menstrual period. On 1/22/01, ER visit with complaint of arm numbness. She did have a panic attack going through this and saw a counselor or therapist. She was put on valium and Celexa. It was ruled that this was not a psychological problem and no situational problem present that would cause this. The doctor told her it was physiological in nature. There has been no clear cut answer as to what happened to her, only that a possible viral infection messed up her nervous system, causing a chemical imbalance. She is currently taking valium and she states if she doesn't take this medicine by 15:00, her hands start shaking.				Y					Y	12/18/2000	12/18/2000	0	EKG X 3 were normal. Her stress test, Echocardiogram, blood work-all wnl. Holter monitor-nml; arterial blood draw to rule out clots-nml; hormone tests, thyroid test-nml	OTH	PUB	NONE	End of 2 week head cold.	Allergy to dust			1						1	Chest pain; Dizziness; Fatigue; Hyperhidrosis; Hypoaesthesia; Injection site pain; Menorrhagia; Nervous system disorder; Panic reaction	FLU3~AVENTIS PASTEUR~U0417AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0169247	04/30/2001	IN	7.0			M	04/18/2001	A report received from a health professional on 04/09/01 concerning a 7 year old, male patient who experienced flu-like symptoms, severe nausea, vomiting, and lethargy one day after receiving the Fluvirin vaccine, IM on 03/01/01, which led to hospitalization. The patient has a relevant medical history of sickle cell disease. The patient received a dose of Prevnar concomitantly. On 03/02/01, the patient experienced a syndrome of events including flu-like symptoms, sever nausea, vomiting, and lethargy for the duration of one week. The patient was not fully ambulatory and required inpatient hospitalization. The reporter was unsure of the duration of hospitalization. The patient was eventually discharged without further complications. After this adverse experience the physician noticed that his current stock of Fluvirin vaccines had partially crystallized. The reporter noted that the storage temp was 33 degrees F, below the recommended 36-46 degrees F for this product. It was recommended that the remainder of the physician's stock be discarded. There was insufficient info to determine the causality assessment of the reporter.					Y				Y	03/01/2001	03/02/2001	1		OTH	OTH	Prevnar was also given, no date provided	sickle cell disease			FLU8APR	1						1	Difficulty in walking; Influenza like illness; Lethargy; Nausea; Vomiting	FLU3~MEDEVA PHARMA, LTD.~E73100LA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0169346	05/01/2001	TX	35.0	35		F	01/30/2001	The pt developed lightheadedness and wheezing, 5 and 10 minutes respectively, post vax. The pt has a medical history of asthma. Follow-up information was received and the pt was treated with asthma medications shortly after wheezing occurred. The pt recovered.									Y	11/30/2000	11/30/2000	0		PVT	OTH	Atrovent; Serevent		Asthma NOS		HQ5479803JAN2001	1						1	Dizziness; Wheezing	FLU3~PFIZER\WYETH~4008175~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0169347	05/01/2001	TX	49.0	49		F	04/18/2001	Subsequent to receiving vax, the pt developed elevated blood pressure, 210/107 mmHg.  The pt states that her blood pressure prior to receiving vax was 150/156 mmHg. On 01/03/2001 she went to see her HCP and her blood pressure was 166/110 mmHg in HCP office. The pt was treated with Micardis mg QD. Medical history includes hypertension.				Y					U	12/01/2000	12/14/2000	13	Blood pressure increased 210/107 (mmHg) Blood pressure increased 186/110 (mmHg)	PVT	OTH	Sular	UNK	Hypertension NOS		HQ5536704JAN2001	1						1	Hypertension	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0169348	05/01/2001	NV	43.0	43		F	01/25/2001	Immediately post vax, the pt developed an injection site reaction characterized by a red, itchy, welt, described as a target. Blood pressure was increased to 132/100. The pt was treated with diphenhydramine and recovered.									Y	01/02/2001	01/02/2001	0	UNK	PUB	PUB	NONE	NONE	adult respiratory distress syndrome; cholelithiasis; pancreatitis NOS; Uterine hemorrhage		HQ5708509JAN2001	1						1	Hypertension; Injection site erythema; Injection site reaction; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4008196~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0169349	05/01/2001	OR	79.0	79		U	01/25/2001	Immediately post vax, the pt developed an injection site reaction characterized by swelling and bruising.									U	01/15/2001	01/15/2001	0	UNK	OTH	OTH	NONE	NONE	UNK		HQ6012617JAN2001	1						1	Injection site haemorrhage; Injection site oedema	FLU3~PFIZER\WYETH~~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0169350	05/01/2001	CA				F	03/28/2001	Following vax, the pt developed swelling of lip and inside the mouth and a rash that is on-going since administration. No further information was available at the date of this report.									U	12/01/2000	12/01/2000	0	UNK	PVT	OTH	UNK	UNK	UNK		HQ6463126JAN2001	1						1	Face oedema; Rash	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0169351	05/01/2001	TN	58.0	58		F	04/03/2001	Subsequent to receiving vax, the pt developed an injection site reaction characterized by focal fatty atrophy in the subcutaneous tissue and numbness.									U	11/27/2000			UNK	PVT	OTH	UNK	NONE	UNK		HQ6994508FEB2001	1						1	Hypoaesthesia; Injection site reaction; Skin atrophy	FLU3~PFIZER\WYETH~4008183~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0169352	05/01/2001	NY	40.0	40		M	04/06/2001	Subsequent to receiving vax, the pt developed an injection site reaction characterized as hard, red and itchy. The pt has had the flu shot many times and has never had a reaction before. The events resolved in one week.									Y	11/28/2000	11/28/2000	0	UNK	OTH	OTH	UNK	UNK	UNK		HQ7338416FEB2001	1						1	Injection site erythema; Injection site induration; Injection site reaction; Pruritus	FLU3~PFIZER\WYETH~4008179~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0169353	05/01/2001	PA	46.0	46		M	04/24/2001	Subsequent to receiving vax, the pt developed swelling at the injection site. The pt reported that in 01/2001 a lump appeared at the injection site and was tender and sore. In 03/2001 a biopsy of the injection site tissue revealed fat necrosis with calcifications.									U	12/19/2000			Biopsy NOS - injection site: fat necrosis with calcifications	PVT	PVT	vitamin D	NONE	UNK		HQ8496616MAR2001	1						1	Injection site mass; Injection site necrosis; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0169354	05/01/2001	NY	59.0	59		F	04/18/2001	Within 1 hour post vax, the pt experienced periodic neuropathy in her feet and hands. She stated that this felt like pins and needles that moved around a bit, then resolved. The reporter also noted that she developed peripheral neuropathy in summer of 2000 while taking Baycol. Baycol was stopped and the symptoms resolved. It was also noted that the pt had taken Mevacor for 10 years and stopped, then restarted in 09/2000 as an alternative to Baycol and experienced a strange dry feeling in her throat. She stopped taking Mevacor and symptoms were resolving as of 01/04/2001.									U	12/01/2000	12/01/2000	0	UNK	PVT	OTH	Premarin	UNK	Dry throat; hypercholesterolemia; hysterectomy NOS; Peripheral neuropathy NEC		HQ5599005JAN2001	1						1	Condition aggravated; Dry throat; Neuropathy peripheral	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0169355	05/01/2001	IL	3.0	3		M	03/21/2001	9 days post vax, the pt developed hives, which extended from the trunk to legs. He was treated with Benadryl which initially resolved the hives; however, they returned by morning.									U	12/23/2000	01/01/2001	9	UNK	PVT	PVT	NONE	NONE	UNK		HQ5710909JAN2001	1						1	Urticaria	FLU3~PFIZER\WYETH~4008182~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0169356	05/01/2001	IL	60.0	60		F	01/25/2001	One day post vax, the pt experienced pain at the injection site. As of 01/12/2001 the pt continued to experience this pain.									U	12/07/2000	12/08/2000	1	UNK	PVT	PVT	NONE	NONE	UNK		HQ5965016JAN2001	1						1	Injection site pain	FLU3~PFIZER\WYETH~4008217~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0169357	05/01/2001	AR				U	04/06/2001	One day post vax, four pts developed an injection site reaction characterized by pain and swelling.  Additional reports will be generated when identifying information is provided.									U	01/23/2001	01/24/2001	1	UNK	PVT	OTH	UNK	UNK	UNK		HQ6464326JAN2001	1						1	Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4008192~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0169358	05/01/2001	SC	34.0	34		F	04/03/2001	Subsequent to receiving vax, the pt developed acute pain at the injection site. The pt was treated with unspecified steroid injections and physical therapy. The reporter indicated that the physician stated that the pain was because the injection was administered too high in the deltoid.									U	12/29/2000			UNK	OTH	OTH	NONE	NONE	UNK		HQ7066409FEB2001	1						1	Injection site pain	FLU3~PFIZER\WYETH~4008201~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0169359	05/01/2001	CA				F	02/15/2001	Subsequent to receiving vax, the pt developed a large local reaction and a diffuse uritcarial eruption all over her body. A diagnosis of allergic was made. She underwent skin testing to the same lot number of the vax, which confirmed an allergic reaction to this product. She has received influenza virus vaccine in the past without incident.									Y	12/01/2000			skin test: confirmed the diagnosis of allergic reaction.	OTH	OTH	UNK	UNK	UNK		HQ7203214FEB2001	1						1	Hypersensitivity; Laboratory test abnormal; Urticaria	FLU3~PFIZER\WYETH~4008221~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0169361	05/02/2001	AL	4.0			U	01/16/2001	A healthcare professional reported that a 4 year old child received an injection of the Flu Shield 2000-2001 formula on 12/8/00. The following day, the child died. No further information was available at the date of this report.	Y	12/09/2000							N	12/08/2000	12/09/2000	1	UNK	PVT	OTH	UNK	UNK	UNK		HQ5878312JAN2001	1						1	Unevaluable event	FLU3~PFIZER\WYETH~4008174~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0169477	05/07/2001	PA	67.0	67		F	12/18/2001	It was reported that a female pt received a Fluzone SV '00-'01 vaccination on 11/10/00. Reportedly, about 2 weeks, post vax, the pt developed progressive weakness in legs, pain in back and difficulty walking-dragging right foot. Family physician and Orthopedist saw pt. From folow-up correspondence received on 12/11/2001 states the electormyogram report:findings- Concentric needle EMG studies of selected bilateral lower and left upper extremity as well as bulbar muscles were examined with concentric needle EMG study. there were abundant changes reflecting acute and chronic denervation as well as fasciculation potentials and/or chronic denervation in bilateral lower and left upper extremities. Thoracic paraspinal muscle EMG on the left. Abnormal study consistent with bilater L4-5 radiculopathies. There are chronic and recent changes present. Multi level degenerative disc disease, disc bulding and spondylosis contributing to multi level ventral extradural ridging from C3-4 throught C6-7 as well as foraminal stenosis. Stenotic changes in the canal are present at C5-6 and C6-7. Annular bulges without significant canal compromise. There is mild bilateral neural foraminal encroachment at L4-5.				Y					N	11/10/2000	11/24/2000	14	MRI and epidural injection was done;Electromyogram-abundant changes reflecting acute and chronic denervation as well as fasciculation potentials and/or chronic denervation in bilateral lower and left upper extremities. Thoracic paraspinal muscle EMG on the left; EMG studies-increased insertional activity with +1 to +3 fibrillations and sharp waves in the left tibialis anterior, right and left peroneus longus and paraspinal muscles with many polyphasic potentials present in the vastus medialis, rectus femoris and tibialis anterior muscles; MRI-multi level degenerative disc disease, disc bulding and spondylosis contributing to multi level ventral extradural ridging from C3-4 through C6-7 as well as foraminal stenosis. Stenotic changes in the canal are present at C5-6 and C6-7. magnetic resonance imaging-annular bulges as described above without significant canal compromise. There is mild bilateral neural foraminal encroachment at L4-5.	OTH	OTH					U2001006750	1						1	Back pain; Difficulty in walking; Muscular weakness; Peroneal nerve palsy; Abasia; Paralysis; Sensation of heaviness	FLU3~AVENTIS PASTEUR~U0346AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|UNK~UNKNOWN MANUFACTURER~~UNK~~~VACCINE NOT SPECIFIED (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0169575	05/08/2001	MI	50.0			F	04/09/2001	Telephone call received from agent to field supervisor stating she received flu shot on 12/26/00 and had a seizure on 12/30/00. History of meningioma surgery removed but off since then. Seizure meds. Called PP who stated no correlation to flu shot but restarted her on seizure meds. (Tegretol). No further seizures since that date.				Y					Y	12/26/2000	12/30/2000	4		PUB	PUB	Lipitor; BP meds		Lipitor for increased cholesterol and BP meds		MI2001030	1						1	Convulsion	FLU3~PFIZER\WYETH~4008224~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0169576	05/08/2001	MI	52.0	52		F	04/03/2001	Telephone call received on 3/21/01 from client to clinic PHN stating she has continued to experience muscle soreness and some weakness of left arm off and on since receiving flu shot on 1/2/01. Saw her doctor who stated there was no infection and did not order any meds. Returned call from supervisor on 4/1/01. Client's arm is gradually getting better but still bothersome. Suggested comfort measures and to return to doctor if condition worsens.				Y					Y	01/02/2001	01/03/2001	1		PUB	PUB					MI2001031	1						1	Muscular weakness; Myalgia	FLU3~PFIZER\WYETH~4008224~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0169577	05/08/2001	TX	45.0	44		F	05/01/2001	Have had pain in left arm (muscle soreness) since receiving flu shot on 11/28/00. Pain is present on upward movement of arm and worse with lifting or pushing.									U	11/28/2000	11/28/2000	0		UNK	UNK			Chronic lymphocytic leukemia	Muscle soreness~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Hypokinesia; Myalgia	FLU3~MEDEVA PHARMA, LTD.~E67370KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0169619	05/09/2001	GA	40.0	40		F	05/02/2001	On 10/2/00, I had an appt. with my PCP and I was dx'd with acute bronchitis and prescribed Zithromax but after taking this, I still was no better. I saw my PCP again on 10/10/00 and she prescribed Cefzil and administered a flu shot. I told her that I thought a flu shot was not to be given if a pt is sick. She replied that it was ok since I was not running a high-grade fever. I did tell her that I had been feverish prior to this visit. I then told her that I had heard of cases in which a pt received a flu shot and then got the flu. To this, she replied, Well, you're sick anyway, so why does is matter? During this time, I was being treated for Insulin Resistance with Glucophage and Amenorrhea with Loestrin Fe. Three days, post vax, I awoke in the middle of the night, with excruciating pain in my left arm, between my shoulder and elbow. The pain lasted a few days but then started in my right arm, in the same location. Days later, I awoke, late at night, with my hands throbbing and swollen. My doctor prescribed Vioxx, Relafen and Darvocet for pain; with no relief. She admitted that the flu shot could have caused my symptoms. She then referred me to a Rheumatologist. After testing, this doctor was leaning toward a dx of rheumatoid arthritis. I saw 2 Allergists, as well as my Endocrinologist and all 3 doctors told me NEVER to take another flu shot. One of the allergists also dx'd me with Poisoning by antibiotic. My Endocrinologist dx'd my problem as serum sickness. I now take Plaquenil, Celebrex and prednisone. My Rheumatologist has found WBC in my right knee. One physician feels that my lymphatic system has been attacked as a result of the flu shot. In addition, I have had a flare of gout. It has been one thing after another. The 60 day follow-up report the pt states sed rate continues to be high, last reading was 45. Sed rate is coming down; however, she now has a new internist and rheumatologist; both concurr that she is experiencing an autoimmune reaction to the flu shot as the timing between the flu shot and the onset of my symptoms is too suspicious and cannot nor should not be ignored. The pain in her upper arms was studied via x-rays and MRI's. She is currently recovering from shoulder surgery; she will see her orthopedic surgen for follow up on 07/30/2001. Insulin resistence. The patient is a 41 year old white female former patient of MD. with a history of insulin resistence, hypertension, obesity and amenorrhea. The patient was initially seen because of weight gain. She was worked up, had thyroid function test, 24-hour urine for cortisol. These were apparently remarkable. She also had an insulin level which was elevated and subsequently she diagnosed as having insulin resistance. The patient returns to the clinic today and reports she is being evaluated by an immunologist because of some joint pain which started several months ago. The patient tells me that her father had diabetes mellitus. Her paternal grandfather and her paternal uncles also have diabetes mellitus. There is no history of dyslipidemia. The patient does have obesity. However she says she is not dieting and has a poor appetite for the past 4 months. She says with diet she was able to lose about 100 pounds. She currently weights 232 pounds and she is 5'8 tall. She is also on Glucophage 850mg t.i.d. The patient does report a history of (white coat hypertension). She also reports that she has irregular periods for about 6 to 9 months now. She says she is on birth control pills for about 15 years. However she was out on birth control pills because of amenorrhea rather than contraception. She says she now has very light periods (2 days only). The patient denies any galacturia, denies any dark pigmentation of the skin. She denies any headaches, denies any focal motor or sensory deficits, denies any peripheral vision cup, diplopia or blurred vision. Otherwise no complaints.				Y				Y	N	10/10/2000	10/13/2000	3	Arthritis panel; lupus test-neg; Sed rate-high; RF-high; CRP-high; nuclear bone scan-no sign of inflammatory arthritis. Per doc 214444, patient states: I continued to be treated for osteoarthritis and rheumatoid arthritis. My internist refers to me as the 'medical mystery'. I have now been referred to another physician, a rheumatologist/Immunologist, several physicians. The flu shot is the investigator in this situation, the shot and the onset of my symptoms cannot  be ignored. I have undergone surgery on my right rotator cuff and will undergo surgery on both knees this summer. Blood tests which tend to trend together are not doing so, thus, the mystery remains. Hopefully, the new physician I am scheduled to see on 06/03/2002 will have some answers. Interestingly, 2 others individuals in my hometown began experiencing the same symptoms I am. All 3 of us had flu shots around the same time at onset of symptoms closely following the vaccine. Neither has reported this to VAERS due to their physicians discouraging them to do so. I feel my situation is not uncommon but severely under-reported. A follow up report received 7/6/2001 adds that final diagnosis is rheumatoid arthritis, not Guillain-Barre syndrome.  Follow up: patient still on predisone, celebrex, prednisone, activity limited-limps, can't bend knees-chronic fatigue.	PVT	PVT	Zithromax, Cefzil, Glucophage, Loestrin Fe, Plaquenil 200 mg, Naprosyn 500 mg, Lasix, potassium, Ultram, Paxil,	Acute Bronchitis	Insulin Resistant, Amenorrhea, drug allergies. Allergies: Cephalosporine, Mepergan, Lorcet and Indocin, Mipregan, loreet plus, coflasporin antibiotics, cheddar cheese, peanuts, corn, wheat, mold, fungus			1						1	Blood creatine phosphokinase increased; Drug interaction; Gout; Immune system disorder; Myalgia; Oedema peripheral; Red blood cell sedimentation rate increased; Rheumatoid arthritis; Rheumatoid factor; Serum sickness	FLU3~AVENTIS PASTEUR~0406AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0169718	05/09/2001	LA	21.0	21		F	02/08/2000	It was reported that a 21 year old female pt received a Menomune A/C/Y/W-135 and a Fluzone SV '99-'00 vaccination on 11/11/99. Reportedly, on 11/12/99, the pt complained of night sweats, dizziness and nausea that lasted 1 day. The pt reportedly, recovered from this experience.									Y	11/11/1999	11/12/1999	1		PUB	PVT		NONE	Asthma		U2000000260	1						1	Nausea; Night sweats	FLU3~CONNAUGHT LABORATORIES~U0149AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~CONNAUGHT LTD.~7363AA~UNK~SC~LA~MENINGOCOCCAL (MENOMUNE-A/C)~1	USA		Influenza
0169736	05/09/2001	TX				U	10/18/2000	It was reported that a pt (1 of 2) received a Menomune A/C/Y/W-135, a TD adult, a Flu (unspecified) vaccination and a PPD Tubersol skin test during the time of 6/8/00 and 6/10/00 (exact date not specified). Reportedly, sometime after the vaccinations, the pt developed reactive arthritis. Further information requested. On 9/6/00, additional correspondence was received from the responsible physician, no additional information was provided.									U	06/08/2000				UNK	UNK	PPD-Tubersol 5 TU/Aventis Pasteur LTD				U2000004920	1						1	Arthritis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~CONNAUGHT LABORATORIES~UA170AA~UNK~SC~~MENINGOCOCCAL (MENOMUNE)~1|TD~CONNAUGHT LABORATORIES~~UNK~IM~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0169737	05/09/2001	TX				U	10/18/2000	It was reported that a pt (2 of 2) received a Menomune A/C/Y/W-135, a TD Adult, a Flu (unspecified) vaccination and a PPD Tubersol skin test during the time of 6/8/00 and 6/10/00 (exact date not specified). Reportedly, sometime post vax, the pt developed reactive arthritis. Further information requested. On 9/6/00, additional correspondence was received from the responsible physician, no additional information was provided.									U	06/08/2000				UNK	UNK	PPD-Tubersol 5 TU/Aventis Pasteur LTD				U2000004930	1						1	Arthritis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~CONNAUGHT LABORATORIES~UA170AA~UNK~SC~~MENINGOCOCCAL (MENOMUNE)~1|TD~CONNAUGHT LABORATORIES~~UNK~IM~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0169665	05/10/2001	NY	80.0	79		F	05/01/2001	This patient had pain in the area where her shots were administered. Saw own MD - x-rays (2 times). Orthopedic, Cortisone shot - physical therapy.								Y	N	04/21/2000	04/25/2000	4	x-ray 2 different times at the hospital.	PUB	OTH		NONE	NONE			1						1	Injection site pain	FLU3~PFIZER\WYETH~4008179~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0169666	05/10/2001	NY	59.0	59		F	01/19/2001	On 01/04/01, this patient became light headed and nauseated 24 hours after receiving Influenza vaccine. It lasted for several hours. Called PCP, and went to the Health Dept, was told to go to PCP or walk-in. The patient felt better and did not go, called PCP and made an appointment for 01/10/01. On 01/10/01, the patient was seen by PCP, he told her it sounded like a reaction, she is fine now.									Y	01/03/2001	01/04/2001	1	NONE	PUB	UNK		NONE	High blood pressure.		NYS21010	1						1	Dizziness; Nausea	FLU3~PFIZER\WYETH~4008177~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0169667	05/10/2001	NJ	53.0	53		F	05/02/2001	Employee reported onset of asthma within 2 days of the flu shot (2000), fever of 101, and it (asthma) has occurred 3 times since then. Treatment with private physician.				Y					Y	10/23/2000	10/25/2000	2		PVT	PVT		NONE	NONE			1						1	Asthma; Pyrexia	FLU3~SANOFI PASTEUR~U0402DA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0169668	05/10/2001	CA	25.0	25		M	05/03/2001	This patient had swollen axillary lymph nodes of the right arm, headache, malaise, diaphoresis, and fevers.									Y	04/27/2001	04/28/2001	1	NONE	PVT	PVT	NONE		NONE			1						1	Headache; Hyperhidrosis; Lymphadenopathy; Malaise; Pyrexia; Acute respiratory distress syndrome; Alanine aminotransferase increased; Anaemia; Apnoea; Aspartate aminotransferase increased; Blood bilirubin increased; Blood creatinine increased; Blood fibrinogen decreased; Blood urea increased; Disseminated intravascular coagulation; Encephalopathy; Fatigue; Gastrointestinal disorder; Haematuria; Hepatic enzyme abnormal; Hepatic necrosis; Hypotension; Leukocytoclastic vasculitis; Lymphadenopathy; Malaise; Myalgia; Proteinuria; Prothrombin time prolonged; Pyrexia; Red blood cell sedimentation rate decreased; Renal failure; Respiratory failure; Sepsis; Serum sickness; Thrombocytopenia; White blood cell count increased	FLU3~AVENTIS PASTEUR~UO446AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~CONNAUGHT LTD.~T05632~UNK~IM~RA~POLIO VIRUS, INACT. (POLIOVAX)~1|YF~CONNAUGHT LABORATORIES~UA440AA~1~SC~RA~YELLOW FEVER (YF-VAX)~1|FLU3~AVENTIS PASTEUR~U0446AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|IPV~SANOFI PASTEUR~T05632~UNK~IM~RA~POLIO VIRUS, INACT. (IPOL)~2|YF~CONNAUGHT LABORATORIES~UA440AA~UNK~IM~LA~YELLOW FEVER (YF-VAX)~2	USA		Influenza
0169829	05/15/2001	OK	22.0	22		M	05/07/2001	Pt remained at vaccine site for 15 minutes and before leaving the site, he began to complain of feeling dizzy and weak, with a stomach ache and SOB. He reportedly, became pale and diaphoretic. Nurse reported lying him on floor. BP was 138/70. Nurse administered 0.5cc Epinephrine SC in the left arm and also had 911 called. EMS responded and checked pt and suggested family take him to ER who then prescribed Benadryl every 6 hours, Pepcid and Medrol dose/pak until seeing PCP on 10/27/00. He a pt of an allergist who is checking allergies to preservatives.				Y					Y	10/21/2000	10/21/2000	0	NONE	PUB	PVT	Claritin po daily for allergies	NONE	Allergies of upper respiratory system.			1						1	Abdominal pain upper; Asthenia; Dizziness; Dyspnoea; Hyperhidrosis; Pallor	FLU3~AVENTIS PASTEUR~U0402EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0169830	05/15/2001	CO	69.0	69		F	01/29/2001	Developed hives (rash, welts) approx. 5 days, post vax. Before hives appeared had nausea and vomiting and diarrhea. Also complained of pruritus which still persists.				Y					Y	12/06/2000	12/11/2000	5		PUB	PUB		NONE			CO01008	1						1	Diarrhoea; Nausea; Pruritus; Urticaria; Vomiting	FLU3~PFIZER\WYETH~4008203~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0169831	05/15/2001	VA	37.0	37		F	11/09/1999	24 hours, post vax, had itching in the injection site, then development of macular eczema-like lesions on trunk and arms.									Y	10/29/1999	10/30/1999	1	Skin scraping	MIL	MIL	Birth control	NONE	History of hernia			1						1	Injection site reaction; Pruritus; Skin ulcer	FLU3~CONNAUGHT LABORATORIES~U0135AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0169880	05/16/2001	FL	38.0	38		F	05/09/2001	This patient had severe generalized fatigue, pain, numbness at many areas of her body; chronic muscle spasms, soft tissue swelling. Diagnosed with fibromyalgia / CFS. The 60 day follow-up states fibromyalgia and chronic fatigue. Per doc 214743, chronic muscle pain, fatigue, disabled, unable to move now for 2 years patient was able to work before. The follow up received on 6/13/01 states, the pt basically has the same complaints she had last time she was in. Unfortunately, other than for the sleep study and neurologic evaluation by Dr, none of the tests that were ordered at hospital were actually performed. The pt still has chronic fatigue as well as numerous musculoskeletal type pain, most notably in the neck and back. She still has trouble swallowing from time to time, however, she does not wish to undergo work up for this at this time. She has not had fever or headaches. She claims there is some element of depression, although she feels this is probably due to the way she feels. Impression: fibromyalgia, history of thyroid nodule, dysphagia, diffuse back pain most notably affecting the C-spine secondary to fibromyalgia/? concomitant degenerative joint disease or other etiology, allergic rhinitis, status post ablation of accessory pathway for Parkinson-White syndrome, menorrhagia/anemia/stopped iron due to gastirc upset, hypotension on the past couple of visits. Endocrinologic evaluation was recommended to rule out adrenocortical insufficiency. Plan: previously recommende tests will once again be ordered. Encocrinologic evaluation is once again recommended. Check labs. Begin Desipramine 1/2 of 25mg tablet qhs for a week and then 25mg tablet qhs thereafter. Reevaluate in a few weeks or prn. Missing vaccine informaton not available. Follow up: patient states she is permanently disabled, unable to work.  Still with symptoms of severe fatigue, and generalized body pain and numbness, mostly on left side of her body.				Y				Y	N	10/31/1995	10/31/1995	0	H and H low at that time; trigger points-all test positive for F/M	PVT	OTH		NONE	Allergies: Eggs, environmental allergies: pollen, trees, can't remember what else.			1						1	Fatigue; Fibromyalgia; Hypoaesthesia; Myalgia; Pain; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0170015	05/21/2001	FL	57.0	57		F	08/16/2001	A 57 year old female reported that she received Flu-Shield ('00-'01 formula) on 11/29/00. On 11/30/00, she experienced pain and numbness in her right leg and foot. She was seen by her physician who was more concerned about her elevated blood pressure. On 12/20/00, the pain reportedly intensified and had spread to her left leg. She was admitted to the hospital where a dx of vasculitis was made. She was treated with cyclophosphamide and was released. On 1/25/01, she developed kidney failure, dehydration and clots and was re-admitted to the hospital. She was told that a virus attacked her T-cells. She underwent a cardiac catheterization to look for clots. She was discharged; however, as of 5/14/01, she was still experiencing pain and numbness in both of her legs. Following changes were made: no other vaccines were given within 4 weeks, this event was considered life-threatening. Follow-up info received from the physician on 08/15/2001, indicated that the pt was diagnosed with mononeuritis multiplex, livedo reticularis, and foot drop. Test results revealed an elevated erythrocyte sedimentation rate, elevated C-reactive protein, and a positive p-antineutrophil cytoplasmic antibody.			Y	Y	Y				N	11/29/2000	11/30/2000	1	Erythrocyte sedimentation rate-increased; C-reactive protein-increased; positive p-antineutrophil cytoplasmic antibody	PVT	OTH	Dyazide, Tenormin	NONE	UNK		HQ0890815MAY2001	1						1	Blood pressure increased; Dehydration; Hypoaesthesia; Livedo reticularis; Mononeuritis; Pain in extremity; Peroneal nerve palsy; Red blood cell sedimentation rate increased; Renal failure; Thrombosis; Type IV hypersensitivity reaction; Vasculitis; Abasia; Antinuclear antibody positive; Arthralgia; Ecchymosis; Paraesthesia; Vasculitis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4008183~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Life Threatening,Hospitalisation	Influenza
0170031	05/21/2001	PA	53.0	53		F	03/19/2001	The pt was diagnosed with chest and abdominal pain. Then went into Guillain Barre Syndrome.			Y		Y	30	Y		Y	12/07/2000	12/31/2000	24		OTH	PVT	UNK	UNK	UNK		PA0134	1						1	Abdominal pain; Chest pain; Guillain-Barre syndrome	FLU3~PFIZER\WYETH~4008177~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0170039	05/21/2001	SC	50.0	50		F	05/05/2001	Within 10-12 hours, onset of diarrhea, tightness in throat, non-productive persistent cough, feeling of choking in base of throat, hot feeling in lungs, chest pains in upper left chest, laryngitis, anxiety, depression; treatment with prednisone, Diflucan, quaifenisen, codeine cough syrup, Ativan. At present, still have cough, diarrhea and anxiety. On 1/10/01 had yeast infection in mouth, throat and vocal cords; treated with Diflucan (3 rounds). On 5/8/01, had 12 day prednisone treatment begun with Diflucan in case of reoccurrence of yeast.				Y					N	12/04/2000	12/05/2000	1	Bronchoscopy on 4/2/01-no physical problem	PVT	PVT	Albuterol, Flovent, Benadryl, Estradiol, Synthroid, vitamins	NONE	Asthma, Hypothyroidism, allergies to grasses, pollens, NSAIDS			1						1	Anxiety; Chest pain; Cough; Depression; Diarrhoea; Fungal infection; Laryngitis; Throat tightness	FLU3~PFIZER\WYETH~4008203~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0170040	05/21/2001	VA	38.0	38		F	04/27/2001	I have been breaking out in rashes on my arms, legs, neck, face and hands. My eyes swell and I have constant tightness on the left side of my chest since June, 2000.				Y					N	11/03/1999	06/01/2000	211		MIL	MIL	NONE	NONE				1						1	Chest discomfort; Eye swelling; Rash	FLUX~UNKNOWN MANUFACTURER~~7+~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0170129	05/23/2001	AL	45.0	45		M	05/08/2001	This patient was admitted thru the ER on 11/04/01 with progressive SOB, chest pain in the mid-chest associated only with cough, and deep breath. According to the family the patient there were no new problems until one day after the patient received the influenza vaccine when he ran a fever and became progressively following that injection. The  influenza vaccine was given about 1 week PTA. On the day of admission, he developed severe, SOB, and developed pleuritic chest pain. RR 28, o2 Sat 50%, O2 by mask was 90% on admit. Also 1-2 + pitting pedal edema present the day of admission. Chest x-ray revealed pneumonia. Initial cardiac enzymes were negative. On admit the patient had scattered rhonchi.	Y						Y		U	10/27/2000	11/04/2000	8	RR 28, o2 Sat 50%, O2 by mask was 90% on admit. Also 1-2 + pitting pedal edema present the day of admission. Chest x-ray revealed pneumonia. Initial cardiac enzymes were negative.	UNK	UNK			Morbid obesity (411 lbs, 5'5), seizure disorder (long standing history), history of GERD, mild to moderate mental retardation, NKDA, history of medication noncompliance, and type II diabetes mellitus.			1						1	Chest pain; Cough; Dyspnoea; Hyperventilation; Hypoxia; Oedema; Pneumonia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0170185	05/23/2001	IN	12.0	10		U	05/16/2001	The pt experienced an indentation, probably necrosis of the left shoulder.									U	10/13/1999	01/05/2001	450		PVT	PUB	Adderal,		asthma, ADHD			1						1	Injection site induration; Injection site necrosis	FLU3~CONNAUGHT LABORATORIES~U0108AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1052J~1~IM~LA~HEP B (RECOMBIVAX HB)~1	USA		Influenza
0170304	05/29/2001		76.0			M	05/23/2001	Information has been received from an investigator regarding a 76 year old male who received a dose of Influenza virus vaccine trivalent, types A & B, live cold-adapted (frozen formulation) on 11/10/98 as a part of the study, a Randomized, Controlled, Blinded, Multi-Center Trial to Assess the Efficacy of Protection From Natural Influenza Virus Infection of Influenza Virus Vaccine Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) and Inactivated Influenza Virus Vaccine in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Field Trial. On 11/16/98, the patient developed an exacerbation of chronic obstructive pulmonary disease. He recovered by 12/01/98. The investigator considered the exacerbation of chronic obstructive pulmonary disease (unexpected per the investigator brochure) to be medically important and possibly related to study vaccine administration. The medical monitor's assessment was unknown.									Y	11/10/1998	11/16/1998	6	NONE	UNK	UNK	UNK		COPD		HQ1160222MAY2001	1						1	Obstructive airways disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0170333	05/29/2001	CA	20.0	20		M	05/10/2001	Pt received typhoid, flu and Hep-A vaccines and approx. 30 seconds, post vax, pt had a syncopal episode with duration of 45 seconds to 1-2 minutes.				Y					U	05/10/2001	05/10/2001	0	NONE	MIL	MIL	UNK	UNK	NONE			1						1	Syncope	FLU3~PFIZER\WYETH~4008200~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEPA~MERCK & CO. INC.~1185K~2~IM~RA~HEP A (VAQTA)~1|TYP~CONNAUGHT LABORATORIES~R08263~1~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0170419	05/31/2001	ID	52.0	52		F	01/30/2001	The pt experienced hives on the left side of the face and neck.									Y	12/12/2000	12/12/2000	0		PUB	PUB			allergy to Keflex, PCN, Cephalasporin			1						1	Urticaria	FLU3~PFIZER\WYETH~4008191~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0170459	06/01/2001	MS	40.0	40		F	05/24/2001	This patient states she had a flu shot 12/07 and took Benadryl 12/07 for a rash to her face and redness to the injection site of the left upper arm. Complains of headache onset last night, diarrhea x 32 today, some nausea, 2 cm area of induration / erythema at left brachium. The patient was discharged.				Y					Y	12/07/2000	12/08/2000	1	12/08 temp 98.8, P 92, R 32, BP 169/102, O2 Sat 100%.	UNK	UNK	Benadryl, Pepto Bismol, Motrin, Valium, and Darvocet.		Allergies: Lorcet, Toradol, Soma, Percocet, Ultram, and Duract.			1						1	Diarrhoea; Headache; Hypertension; Hyperventilation; Injection site erythema; Injection site induration; Nausea; Pyrexia; Rash; Tachycardia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0170477	06/01/2001	MA	44.0	43		F	05/02/2001	Sore shoulder pessisted many months after shot.  Now getting PT for it.  My physical therapist says I'm the 3rd person she's seen who has reported long term muscle soreness after this year's flu shot									N	11/01/2000				MIL	PUB		NONE				1						1	Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0170570	06/05/2001	SC	16.0	16		M	05/16/2001	The pt experienced swollen, erythematous, tender injection site 12 hours post vax.				Y					Y	12/05/2000	12/05/2000	0		PVT	PUB	Zyrtec, Singulair, Zithromax, Albuterol, Intal					1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~AVENTIS PASTEUR~U0408AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~474963~1~IM~RL~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0170571	06/05/2001	SC	7.0	7		F	05/31/2001	The pt experienced a swollen, erythematous and tender injection site occurring 12 hours post vax.				Y					Y	11/28/2000	11/29/2000	1		PVT	PUB	Claritin, Singulair, Intal, Volmax	NONE	allergies, asthma			1						1	Injection site oedema; Injection site pain	FLU3~AVENTIS PASTEUR~U0417AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~469133~1~IM~RL~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0170572	06/05/2001	SC	15.0	15		M	05/16/2001	The pt experienced swollen, erythematous and tender injection site, which occurred 12 hours post vax.									Y	02/21/2001	02/21/2001	0		PVT	PUB	Palmicort, Albuterol, Intal, flonase, Ceftin, Allegra, Singulair					1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~AVENTIS PASTEUR~U0465AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~474936~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0170573	06/05/2001	SC	11.0	11		M	05/16/2001	The pt experienced swollen, erythematous and tender injection site which occurred 12 hours post vax.				Y					Y	11/21/2000	11/22/2000	1		PVT	PUB	Volmax, Augmentin, Vioxx, Zantac, Claritin, Singulair, Zoloft, Ceftin		nasal allergies			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~AVENTIS PASTEUR~U0408AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SMITHKLINE BEECHAM~ENG3199D9~1~IM~LL~HEP B (ENGERIX-B)~1|PPV~PFIZER\WYETH~469133~1~IM~RL~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0170625	06/06/2001	GA	46.0	46		F	05/22/2001	11/2/00, sudden onset of severe vertigo and nausea, lasting 6 hours and lingering for several days. On 11/6/00, sudden onset severe vertigo and nausea, lasting 10 hours and lingering several days. Saw ENT MD on 11/7/00 and was prescribed valium and rest. I had follow-up with MD ENT on 11/17/00. I continue to have frequent periods of mild motion sickness and periods of feeling off balance.				Y					N	10/26/2000	11/02/2000	7		PUB	UNK	NONE	NONE	NONE			1						1	Balance disorder; Nausea; Vertigo	FLU3~MEDEVA PHARMA, LTD.~E62700HA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0170626	06/06/2001	FL	76.0			F	05/23/2001	I am listing all of the doctors we have been to and I will start with our family doctor who is an Internal Medicine doctor where I had the worst symptoms. He had a neck X-ray and an MRI of the head and brains to rule out that area of real concern. Then I went to a Gastroenterologist and had a gastroscopy and Endoscopy. Then I went to an Infectious Disease doctor and then I went to a Rheumatologist. After all of the doctors and all the tests were completed; all were negative. This all started on 12/01/00, when my wife and I went to MD for our Flu shot at 08:30 AM and at 18:00PM, that night, I started and the next day my wife started with the same symptoms I had. At that time we were both eating roast duck which we bought at a public store. These ducks came pre-cooked and frozen (you just cook them for 45 minutes). We had been eating them for some time. When we went to buy more they stated the store had a recall on them. After a time of being sick, I asked the store manager what the recall was for. He checked and could not find what the cause was, for the recall. We tried to think what we both done and the only thing was the Flu shot and the duck where there was a recall on them. I wonder if you and your associates could please help us if possible to get to the bottom of this nightmare. It has been hell on earth with all the symptoms of violent headaches (both front and rear), sore muscles, raw stomach, dry mouth, metallic test in the mouth and we feel like we are dehydrating with all the water we are drinking, runny nose, perfuse sweating and neck pains. I thank you people for anything you can do for us and will do whatever it takes.				Y					N					PVT	PVT	Synthroid 0.075mg	NONE	Hypoglycemia			1						1	Abdominal pain upper; Dry mouth; Headache; Hyperhidrosis; Myalgia; Neck pain; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0170627	06/06/2001	FL	76.0	76		M	05/23/2001	Generalized aches and pain, headache, profuse sweating, dry mouth, increased thirst, metallic taste, beginning on the evening of shot. He had eat some roast duck that had a recall and a flu shot as well as his wife, and they both had the same symptoms and he wants to know if there is a connection with the food or the flu shot that is still causing them both to be sick. Follow up on 08/08/2001: Patient believes to have a reaction to a flu shot that he received this past December.  Since his shot, he has experienced headaches, sweating, and burning in his stomach.  He apparently has been extensively worked up by another MD, ID, and rheumatology without determining any cause for his symptoms.  This includes dry mouth, sore gums.  He has myalgias.  He states that his eyes feel swollen.  He is fatigued and he also has trouble with songs running through the mind.  His weight has been stable.  He has been afebrile.  There has been no skin rash and workup thus far has been unremarkable. Simple blood tests and an MRI scan of the brain have been normal.  He has not tried any specifiec therapy and he only takes symptomatic therapy for his headaches.  This does not at all seems like a reaction to a vaccine, although he seems to date the onset to that time.  This is not typical for a vaccine reaction and it in fact is not typical for anything that I can think of.  Nevertheless, it seems persistent and the patient claims that he was doing well prior to it.  At this point, initial evaluation has been unremarkable to establish a diagnosis.  Perhaps it is possible for a vaccine to trigger an autoimmune of other type of reaction, although that does not seem to be the case here either.  In any case, the patient does not seem to be deteriorating since his weight is stable and his laboratory studies have been okay.  At this point we will pursue the evaluation to make sure we are not over looking anything more serious.				Y					N	12/12/2000	12/12/2000	0	Neck X-ray; MRI of head and brains; Gastroscopy; Endoscopy; Rheumatology check; Infectious Disease check-all nml; Cortisol PM: 10.2; ESR: 3; MRI of cervical spine;	PVT	PVT	Carafate, Coumadin, Endoet, Alternagel, Prevacid, Temazapam, Vitamins	NONE	Prostate Ca in remission, Demerol, IVP dye, Colonoscopy (05/22/1998): mild proctitis; EGD (05/22/1998): Status post nisson Fundoplication-Clo (-); Decreased hearing; Stomach surgery in 1950's for ulcer disease, Degenerative heart disease; Prostate cancer, status post radical prostatectomy followed by radiation and Lupron, followed by MD.			1						1	Dry mouth; Dysgeusia; Headache; Hyperhidrosis; Pain; Thirst	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0170628	06/06/2001	GA	45.0	44		F	05/25/2001	Vertigo-8 days; dizziness with headache-30 days.									U	10/26/2000	11/11/2000	16		UNK	UNK		NONE	NONE			1						1	Dizziness; Headache; Vertigo	FLU3~MEDEVA PHARMA, LTD.~E62700HA~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0170629	06/06/2001	MA	31.0	30		M	05/30/2001	Approx. 5 minutes, post vax, pt developed cough, profuse diaphoresis, pulse increased to 100, numbness and tingling in jaw/teeth. Given 0.3cc of epinephrine on right thigh, 911 ambulance/EMT's took pt to hospital. Rx'd IV Benadryl and some other medication. Pt cannot remember none of the other medications that he was given at the hospital. Pt had complete and uneventful recovery.				Y					Y	11/28/2000	11/28/2000	0	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Cough; Heart rate increased; Hyperhidrosis; Hypoaesthesia oral	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0171773	06/18/2001	CA	57.0	56		F	06/11/2001	The pt experienced severe vertigo, nausea, tiredness for over 1 1/2 weeks. This reoccurred several times over the next 5 months.				Y					Y	11/11/2000	11/12/2000	1	NONE	PUB	PVT	Synthroid, Premarin, Progestin, multivitamins, DHT - vitamin D	NONE	nephrectomy,			1						1	Fatigue; Nausea; Vertigo	FLU3~PFIZER\WYETH~U0409AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0171976	06/19/2001	MD	26.0	26		F	06/13/2001	Received influenza 11/30/00 and 1 week later, had right shoulder numbness that progressed into weakness, paresthesia, started bumping into things. Also, had right side weakness in right leg not as had in arm. Dx: Transverse Myelitis on 12/27/00. The 60 day follow-up states that pt last seen on 08/15/2001 and condition has improved (resolved).				Y	Y	3			Y	11/30/2000	12/06/2000	6	MRI-revealed lesion at C3; LP; Evoked potentials; multiple Blood tests (looking for infection and auto immunity)	MIL	MIL	OCP's	NONE	Seasonal allergic rhinitis; atopic dermatitis			1						1	Cerebrovascular disorder; Difficulty in walking; Hypoaesthesia; Muscular weakness; Myelitis transverse	FLU3~PFIZER\WYETH~4008210~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0172011	06/19/2001	DC	67.0	66		M	11/30/2000	Continued itching over shot site, starting 1 day post shot continuing for 3 days. Still has itching today (day #3)									N	11/27/2000	11/28/2000	1		MIL	UNK						1						1	Injection site hypersensitivity; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0172317	06/22/2001	PA	34.0	34		M	06/19/2001	A nurse reported that a 34 year old male now 36 years of age, received an injection of Flu Shield '99-'00 formula, in 10/99. Approx. 1 week later, he was dx'd with Guillain-Barre Syndrome. The pt was hospitalized and recovered. No further information was available at the date of this report. This report of a serious, labeled event is being submitted in a 15 day time frame.					Y				Y	10/01/1999			UNK	OTH	OTH	UNK	UNK	UNK		HQ2168218JUN2001	1						1	Guillain-Barre syndrome	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0172356	06/25/2001	AZ	79.0	77		F		General paralysis, cloudiness of mind, breathing difficulties, bloating, chronic colds, flu, runny nose, phlegm, aches, pains in muscles, excessive diarrhea, nervousness, headaches, fever, anaphylaxis and more, etc.				Y	Y	7	Y	Y	N	12/01/1998			electrolyte drop, and more, etc.	PVT	PVT			NONE			1						1	Abdominal distension; Anaphylactic reaction; Bradyphrenia; Diarrhoea; Dyspnoea; Electrolyte depletion; Headache; Influenza; Nasopharyngitis; Nervousness; Pain; Paralysis; Pyrexia; Rhinorrhoea	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0172367	06/25/2001	NY	44.0	44		M	06/15/2001	Patient developed pain in his right arm and had difficulty lifting his arm. He felt that he got flu symptoms, including muscular pain and weakness. He took Advil.									Y	03/21/2001	03/22/2001	1	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Asthenia; Hypokinesia; Influenza like illness; Myalgia; Pain	FLU3~PFIZER\WYETH~4008188~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0172389	06/26/2001	WA	65.0			M	01/22/2001	2 days, post vax, became ill with general malaise and short of breath. Called 911 and was hospitalized for 9 days. (Has not returned phone calls. Unable to get additional information). TX: Antibiotic and IV. Dx'd with pneumonia.			Y		Y	9			Y		01/11/2001		CXR, blood culture, metabolic panel, sed rate, respiratory culture, UA screen, theophylline level, gram stain	PUB	UNK	Atrovent, Albuterol, Cardura, Pulmocort, Theophylline	UNK	Asthma, BHP		WA011749	1						1	Dyspnoea; Malaise; Pneumonia	FLU3~PFIZER\WYETH~4008220~2~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0172391	06/26/2001	PA	69.0	68		F	05/14/2001	Two weeks following immunizations with flu vaccine developed cough, coryza, weakness over the course of week developed dysarthia, dysphagia with cranial nerve paresis on exam. Diagnosed with ALS. According to 213289, 60 day follow up, patient died 03/20/2002 from ALS, unassociated with flu vaccine.  Follow up on 09/18/2001: The patients right arm was prepped and draped in a sterile fashion.  1% Xylocaine was employed for local anesthesia.  A hand injection of contrast through a peripheral angiocath provided opacification of the deep veins of the right arm.  The right basilic vein was accessed under fluoroscopic guidance with a micropuncture set.  A cook PICC catheter was then trimmed to a length of 36cm and advanced through a peel-away sheath into the SVC.  A hand injection of contrast through the catheter reveals the tip in the superior vena cava. The catheter was flushed and sutured in place.  The catheter was then heparinized with 400 units Heparin and the patient was returned to the post-operative lounge in stable condition. 	Y	03/20/2002						Y	N	10/06/2000	10/20/2000	14	MRI - neg, Lyme - neg, EMG w/tensilon test - neg	PUB	UNK		NONE	NONE		PA0147	1						1	Asthenia; Cough; Dysarthria; Dysphagia; Paresis; Rhinitis	FLU3~MEDEVA PHARMA, LTD.~E68780KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0172521	06/27/2001	IL	89.0	89		F	06/15/2001	Patient developed a severe contusion-appearing, firm area on arm at site of injection. This lasted greater than one month.									Y	11/08/2000	11/12/2000	4	NONE	UNK	UNK			hypertension, actinic keratosis, diabetes, overweight, osteoarthritis of thumb			1						1	Contusion; Injection site induration	FLU3~PFIZER\WYETH~4008173~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0172566	06/28/2001		51.0			M	06/25/2001	Information has been received from an investigator concerning a 51 year old male who received placebo for influenza virus vaccine, trivalent, types A & B, live cold adapted (frozen)(nasal solution) along with 1998-99 formula inactivated influenza virus vaccine (mfr unk) on 11/4/98 as part of a clinical trial. The pt experienced a mild exacerbation of chronic obstructive airways disease and was hospitalized. The subject also stated his post traumatic stress disorder was acting up and if he was not admitted to the hospital at that time, he may kill himself. The investigator felt the exacerbation of chronic obstructive airways disease was possibly related to study product or concomitant vaccine administration. The medical monitor's assessment was unknown.					Y				Y	11/04/1998	02/21/1999	109	NONE	UNK	UNK	UNK		Chronic obstructive airways disease; peptic ulcer; benign prostatic hyperplasia; post-traumatic stress disorder		HQ2344421JUN2001	1						1	Anxiety; Condition aggravated; Obstructive airways disorder	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0173040	07/09/2001	MI	58.0			M	07/03/2001	Post vaccination pt presented with mental status changes and oliguria following a several day history of feeling fatigued. He also had a rash on his shins. He was admitted to the hospital approximately 2 weeks post immunization. He was afebrile but tachycardic. PE showed flaccid paralysis, decreased deep tendon reflexes and bilateral Babinski signs. A petechial rash was noted on both shins. The event was managed with plasmapheresis and hemodialysis. The pt has since recovered. It was noted that it is likely that the influenza vaccine triggered the antibody formation and immune complex deposition and led to the development of TTP.					Y				Y				Hemoglobin-11.7; blood lactate dehydrogenase-inc; platelet count-13000 cells/mm3; BUN and serum creatinine-inc; ANA-1:160 titer; non-drug dependent IgM pos; all other laboratory/diagnostic tests were normal or negative.	OTH	OTH	Glipizide, Metformin, Metoprolol, Nitro-Bid, Omeprazole, Quinine	UNK	hypertension, chronic obstructive airway disease, diabetes mellitus		HQ2574727JUN2001	1						1	Anaemia; Antinuclear antibody positive; Autoantibody positive; Blood creatinine increased; Blood lactic acid increased; Blood urea increased; Extensor plantar response; Fatigue; Immune system disorder; Immunoglobulins increased; Mental impairment; Oliguria; Paralysis flaccid; Petechiae; Rash; Tachycardia; Thrombocytopenia; Thrombotic thrombocytopenic purpura	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0169477	07/16/2001	PA	67.0	67		F	07/10/2001	Received injection on 11/10/00 and symptoms started on 11/25/00; such as paralytic legs (both) and weakness and heaviness. I am now walking with a walker with wheels in the front. I have a fear that my legs will collapse at any time and I will fall.			Y						N	11/10/2000	11/25/2000	15	x-rays, five (5) MRI's, 2 EMG's, numerous blood tests	PUB	PUB	NONE	NONE	NONE			1						2	Back pain; Difficulty in walking; Muscular weakness; Peroneal nerve palsy; Abasia; Paralysis; Sensation of heaviness	FLU3~AVENTIS PASTEUR~U0346AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|UNK~UNKNOWN MANUFACTURER~~UNK~~~VACCINE NOT SPECIFIED (NO BRAND NAME)~2	USA	Life Threatening	Influenza
0173342	07/16/2001	CA	15.0	15		F	07/10/2001	Pt had a headache and fainted after shot. The following day, she had paralysis of left side of face. Treatment was to lay down; take antiviral medicines for 5 days and steroid medicines for 10 days.				Y					Y	01/01/2001	01/02/2001	1	Neurologist consult; Cat Scan; Physical exam	PVT	UNK	NONE	NONE	NONE			1						1	Facial palsy; Headache; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0173388	07/18/2001	CA	26.0	26		F	07/11/2001	Urticaria/hives, itchy rash over much of body. Right arm paresthesias. Had a TD vaccination on 7/25/00.									Y	07/03/2001	07/09/2001	6	NONE	MIL	MIL	PPD/Connaught/C0824AA/ID/LFA/2 previous doses; oral contraceptive	NONE	NONE			1						1	Paraesthesia; Urticaria	FLU3~PFIZER\WYETH~4008287~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|IPV~CONNAUGHT LTD.~T0757~1~SC~~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0024L~2~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0173400	07/18/2001	MA	71.0	71		F	06/06/2001	By 3:00 pm post-vax, the patient was having a heavy heartbeat which lasted several hours. By 5:00 pm, the patient was not feeling well. She felt extremely warm, slightly nauseous, her heart hurt, her arm ached, and the right side of her throat felt swollen. These symptoms lasted about 30 minutes. The patient then had chills. The following day the patient felt tired and weak.									Y	01/17/2001	01/17/2001	0	NONE	PVT	OTH	Vitamins, Lorazepam, Phosphate Fluoride Rinse	NONE	NONE	10/95~Influenza (Seasonal) (no brand name)~1~66.00~In Patient		1						1	Asthenia; Chest pain; Chills; Fatigue; Feeling hot; Malaise; Nausea; Pain; Pharyngeal oedema	FLU3~PFIZER\WYETH~4008233~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0173433	07/19/2001		69.0	69		F	05/22/2001	Information has been received describing a 69 year old female with a history of osteoporosis and rheumatoid arthritis who received an influenza virus vaccine on 1/30/01, the same day that she also received her quarterly infusion of pamidronate. Concomitant therapy included Enbrel (etanercept), prednisone, omeprazole, atenolol, levothyroxine, aspirin and simvastatin. Two days later, on 2/01/01, she developed fever of 106F with joint pains. She was hospitalized and treated with amoxicillin clavulanic acid for 2 days. Therapy was discontinued when the possibility of an infection was ruled out by her physician. The pt recovered. The reporter noted that the treating rheumatologist considered the events to be temporally related to the pamidronate infusion or the influenza virus vaccine. See related Enbrel report HQ0850614MAY2001.					Y				Y	01/30/2001	02/01/2001	2	on 02/01/2001 body temperature for pt was 106 degrees F	OTH	OTH	Bayer aspirin; Atenolol, Embrel, Levothyroxine, Omeprazole, Pamidronate Disodium, Prednisone,Simvastatin	UNK	Osteoporosis NOS; Rheumatoid arthritis		HQ1063318MAY2001	1						1	Arthralgia; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0173434	07/19/2001	TX	65.0	65		M	06/01/2001	A wife reported that her 65 yr old husband received an injection of Flu Shield 2000-2001 formula in late November 2000. In January 2001, he developed facial paralysis, numbness, and dizziness. She indicated that her husband related these symptoms to the Flu-Shield. The reporter stated that her husband has recently been dx with a slight elevation in hypertension and was prescribed Atacand. Additional information received from the pt, a physician , on 05/21/2001 indicated that in addition to those symptoms reported by his wife, he is experiencing tremor, foggy memory, blurred vision, and a feeling of heaviness in his face, particularly around the orbital muscles. The pt has consulted with several physicians and stroke was ruled out.				Y					U	11/01/2000	01/01/2001	61	MRI results were atypical with white matter distant from the ventricles.	OTH	OTH	Atacand	UNK	UNK		073611	1						1	Dizziness; Facial palsy; Hypoaesthesia; Memory impairment; Tremor; Vision blurred	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0173435	07/19/2001	TX	39.0	39		F	07/12/2001	A pt who received a dose of Flu-Sheild on 12/20/2000 subsequently experienced pain in all her joints. She was seen by a physician and prescribed oral Prednisone. She indicated that she was allegedly dx with post traumatic arthritis 8 days post vaccination. As of 06/26/2001, she stated that pain persists her right ankle only. Follow-up received from the pt on 9/11/02, stated that a lymph node biopsy will be performed mid-September 2002, for possible sarcoidosis.									U	12/20/2000	12/28/2000	8	unk	OTH	OTH	none	none	unk		HQ2620428JUN2001	1						1	Arthralgia; Arthritis; Joint swelling	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4008180~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0173436	07/19/2001	MT	44.0	43		F	05/25/2001	a 44 yr old female pt received an injection of Flu Shield 2000-2001 on 12/13/2000. Subsequent to a blood drive on 02/19/2001, her blood tested positive for hepatitis C and HTLV 1 & 2. The Red Cross told the reporter that a false positive reaction laboratory test interference nos with influenza vaccine was possible. The abnormal laboratory results were received on 03/15/2001.									U	12/13/2000	02/19/2001	68	02/19/2001 antibody nos test abnormal. Blood tested positive for hepatitis C and HTLV 1 & 2.	UNK	UNK						1						1	Hepatitis C virus	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0173437	07/19/2001	CT	28.0	28		F	05/08/2001	A physician reported that a 28 yr old female received an injection of Flu Shield on 12/26/2000. On 12/28/2000. she developed  numbness in her left leg and treated with and pins and needles in her left foot. She was seen by the physician and treated with prednisone. She was later seen by a neurologist after her symptoms persisted and treated with more prednisone. She then developed tremors in both legs and received tx with Carbamazepine. Additional info received form the physician on 04/30/2001 indicated that her sx have slowly resolved. MRI imaging of her brain and spine were normal. Additional information have slow received on 04/03/2001 her sx have slowly resolved, but she only has numbness 0f the upper back.				Y					Y	12/16/2000	12/28/2000	12	MRI results Normal brain and spine images	OTH	OTH	UNK	UNK	UNK		HQ9404606APR2001	1						1	Hypoaesthesia; Paraesthesia; Tremor	FLU3~PFIZER\WYETH~4008195~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0173438	07/19/2001	NC	55.0			M	05/31/2001	Neuritis - A pharmacist reported that a 55 yo pt rec'd an injection of Flu Shield (2000-2001 Formula) vaccine and, within 48 hrs post vaccine,pt developed neuritis/neuropathy in his R arm. The condition lasted 4 wks and completely resolved. This report was received from Aventis Pasteur (U2001-004830).				Y					Y				UNK	PVT	PVT	UNK	NONE	UNK		HQ0604407MAY2001	1						1	Neuritis; Neuropathy	FLU3~PFIZER\WYETH~4008201~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0173439	07/19/2001	IL				M	06/06/2001	Injection site reaction - an adult pt rec'd an injection of Flu Shield (2000-2001 Formula) in Oct 2000, and developed soreness at the injection site. With a day or two, the injection site pain extended to his shoulder and to his elbow joint which became sore at full extension or under load. As of 5/17/01, he reported that the condition has stabilized and continues to the current time and affects both shoulders. The second shoulder is affected to a minor degree. No further information was available at the date of this report.									U	10/01/2000	10/02/2000	1	UNK	OTH	OTH	UNK	UNK	UNK		HQ1562901JUN2001	1						1	Arthralgia; Injection site pain; Injection site reaction; Tenderness	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0173440	07/19/2001					F	06/04/2001	Influenza - a consumer reported that recently her friend may have inadvertently rec'd a double dose of the influenza virus vaccine (2000-2001 Formula) and subsequently developed a bad case of the flu. The reporter declined to provide further information and declined to grant permission for follow-up investigation.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ9605112APR2001	1						1	Influenza	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0173435	07/20/2001	TX	39.0	39		F	07/16/2001	Swelling of all joints, ongoing, decreasing with time. Pt has taken flu vaccine in the past without adverse reactions.									U	12/19/2000	12/28/2000	9	UNK	OTH	PUB	NONE	NONE	NONE			1						2	Arthralgia; Arthritis; Joint swelling	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4008180~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0173600	07/25/2001	CA	79.0			F	08/17/2001	To date, 08/17/2001 the patient received a flu shot on 10/27/2000 and experienced several days of illness. The patient has had hives off and on to date. The patient never had hives prior to 11/16/2000.				Y					N		11/16/2000		Blood work	PVT	PVT	Blood pressure pills, vitamins, and aspirin	NONE	NONE			1						1	Malaise; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0173601	07/25/2001	CA	70.0	70		F	07/13/2001	The patient developed a cough, esophageal inflammation, a sore throat and hoarseness, shortness of breath, fatigue, and weakness.				Y					N	11/09/2000	11/11/2000	2	Flexible laryngoscopy, CT chest with contrast, and fiberoptic bronchoscopy	OTH	UNK	Normodyne, Zocor, premarin	NONE	HTN, ASHD, Elevated Cholesterol	~Influenza (Seasonal) (Fluzone)~1~68.00~In Patient		1						1	Asthenia; Cough; Dysphonia; Dyspnoea; Fatigue; Oesophageal disorder; Pharyngolaryngeal pain	FLU3~AVENTIS PASTEUR~U0409AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0173657	07/27/2001	OH				F	08/15/2000	A nurse reported that a female received an injection of 1985-1986 formula influenza virus vaccine, manufacturer unknown, in 1985 and subsequently developed terrible joint problems. No further information was available at the date of this report.									U	01/01/1985			UNK	OTH	OTH	UNK	UNK	UNK		HQ9056104JUL2000	1						1	Arthropathy	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0173673	07/27/2001	TX	59.0	59		F	11/12/1998	Post vax patient experienced chills, fever, headache and neck pain.				Y					U	10/23/1998	10/24/1998	1	CT Scan, lumbar puncture neuro eval	PUB	PUB	NONE	NONE	High blood pressure		SA98D	1						1	Headache; Neck pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0173802	08/01/2001	CA	40.0	39		F	07/12/2001	Bruising at site, post vax, on 6/19/01. Reports of pain in left arm since shot was given.				Y					U	12/13/2000				PUB	UNK						1						1	Ecchymosis; Injection site reaction; Pain	FLU3~AVENTIS PASTEUR~U0414BB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0173891	08/06/2001		75.0			M	08/02/2001	Information has been received from an investigator regarding a 75 year old male who received a dose of influenza virus vaccine trivalent, types A & B, live, cold adapted (frozen formulation) on 12/1/98 as part of the study, A Randomized, Controlled, Blinded, Multi-Center Trial to Assess the Efficacy of Protection From Natural Influenza Virus Infection of Influenza Virus Vaccine Trivalent, Types A & B, Live, Cold-Adapted (CAIV-T) and Inactivated Influenza Virus Vaccine in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Field Trial. On 12/5/98, the pt developed an exacerbation of chronic obstructive pulmonary disease. He recovered by 12/11/98. The investigator believed that exacerbation of chronic obstructive pulmonary disease (unexpected per the investigator brochure) was Medically Important and possibly related to study vaccine administration. The medical monitor's assessment is unknown. Follow-up information received on 6/14/01, indicated that the pt received an injection of Fluvirin along with a dose of influenza virus vaccine trivalent, types A & B, live, cold adapted (frozen formulation). On 12/5/98, he developed increased shortness of breath. On 12/8/98, the pt experienced palpitations with exertion. He was seen in an ER where a chest x-ray and an EKG show no acute changes. The assessment remained unchanged. Additional follow-up received on 8/1/01, indicated that the pt was treated with Augmentin (amoxicillin clavulanate) and prednisone. There was no change in the original assessment. This was a nasal solution.									Y	12/01/1998	12/05/1998	4	EKG-no changes; X-ray chest (NOS)-no changes	UNK	UNK	UNK		COPD		HQ1160422MAY2001	1						1	Condition aggravated; Dyspnoea; Obstructive airways disorder; Palpitations	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0164095	08/07/2001	ME	32.0	32		F	07/30/2001	Information has been received concerning a pt who post vaccination had a fever of 100-101 F. There was a .5 inches of and swelling of right arm at the injection site, tenderness and limited range of motion. The pt went to the emergency room and was given Motrin and Amoxicillin and Augmentin. On 12/11/2000 the pt recovered.				Y					Y	12/05/2000	12/06/2000	1	Temperature measurement on 12/06/00 was 100-101	PVT	PVT		pharyngitis	Medical history: contact dermatitis, poison sumac rash. Concurrent conditions: allergic rhinitis, ampicillin allergy, and asthma		WAES00120733	1						2	Injection site pain; Injection site swelling; Joint range of motion decreased; Pyrexia	FLU3~EVANS VACCINES~E617606A~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~1068K~UNK~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0165418	08/07/2001	NV				F	07/30/2001	On an unspecified date, the pt experienced neck pain and shoulder pain. The pt recovered from her experiences after two weeks. The pt did not seek medical attention. Additional information has been requested.									Y	11/13/2000				PVT	OTH			UNK		WAES01010968	1						2	Neck pain; Pain; Neck pain; Shoulder pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1|FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0174074	08/07/2001	IL				M	07/30/2001	Information has been received concerning a pt who on 10/31/00 was vaccinated and post vaccination on 11/02/00 the pt complained of redness, swelling, and induration.									U	10/31/2000	11/02/2000	2		UNK	UNK			UNK		WAES00110356	1						1	Injection site erythema; Injection site induration; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0174076	08/07/2001	MI				F	07/30/2001	Information has been received concerning a pt with myasthenia gravis, arthritis and has used a wheelchair with a history of influenza symptoms and pneumonia on 01/012000 that resulted in hospitalization. On 11/02/00 the pt experienced soreness and her nose was runny. On11/03/00 the pt reported her eyes feel funny like she was getting a cold, and has a sore throat and a tight feeling in her chest.					Y				U	11/01/2000	11/02/2000	1		UNK	UNK	aspirin w/codeine phosphate, Premarin, globulin immune, Synthroid, Provera, Vivactil		medical history influenza sx, pneumonia, concurrent conditions: arthritis, wheelchair user, myasthenia gravis		WAES00110462	1						1	Chest discomfort; Eye disorder; Influenza like illness; Pain; Pharyngolaryngeal pain; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0174077	08/07/2001	IL				F	07/30/2001	Information has been received from a Pharm. D concerning a female pt who on 10/31/00 was vaccinated. On approximately 11/02/00 the pt complained of redness, swelling and induration.									U	10/31/2000	11/02/2000	2		UNK	UNK					WAES00110505	1						1	Injection site erythema; Injection site induration; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0174086	08/07/2001	IL				U	07/30/2001	Information has been provided that a pt had been given a pneumococcal vaccine and influenza vaccine in the same syringe. The pt experienced some cellulitis at the injection site but no other symptoms were noticed.									U					UNK	UNK			UNK		WAES00110931	1						1	Cellulitis; Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0174127	08/07/2001	MA				M	07/30/2001	Information has been received concerning a pt who post vaccination, had a site reaction with pain at the injection site and redness from his shoulder to his wrist.									U	11/01/2000				UNK	UNK			UNK		WAES00111882	1						1	Erythema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0174130	08/07/2001	MN	59.0	59		F	07/30/2001	Information has been received concerning a pt who post vaccination experienced a severe local reaction, the entire upper arm was very swollen,red, hot, tight and severely painful. On 11/17/00 it was reported the pt had dizziness and unspecified medical attention was sought.  The pt recovered from her experience on 11/20/2000.				Y					Y	11/16/2000	11/16/2000	0		OTH	OTH	Atenolol, Lipitor, Prevacid		Medical history: cholecystic surgery, concurrent conditions: Amoxicillin allergy, hypercholesterolemia, and atherosclerosis		WAES00112116	1						1	Dizziness; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~PFIZER\WYETH~4008180~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0690K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0174224	08/07/2001	IL	57.0	57		M	07/30/2001	Within the hour post vaccination the pt experienced a local reaction which included erythema, warmth, which spread distally to the elbow. 20 cmX20 cm with difficulty extending the arm and right thumb.				Y					U	11/29/2000	11/29/2000	0		UNK	UNK			UNK		WAES00120139	1						1	Injection site erythema; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0174229	08/07/2001	MD	23.0			M	07/30/2001	Information has been received concerning a pt,  who after 2 days post vaccination returned to his physician with redness, swelling, and soreness in left arm and fever of 100.3 F.				Y					U	12/06/2000	12/08/2000	2		UNK	UNK			UNK		WAES00120716	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0174254	08/07/2001	TX				F	07/30/2001	Information has been recvd from a pharmacist concerning a patient. Pt's first dose of pneumococcal vaccine 23 polyvalent was administered in 1995. Pt recvd concomitant therapy in the same arm but administered with a different syringe. On 2/19/00, pt experienced a fever and redness, pain and swelling of the injection sites from the shoulder to the elbow. On 2/23/01, pt was seen by MD and was placed on prednisone. Subsequently, the symptoms are subsiding. No further info was provided. Addtl info has been requested.				Y					N	02/19/2001	02/19/2001	0		OTH	OTH			UNK		WAES01030007	1						1	Injection site erythema; Injection site pain; Injection site swelling; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~2~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0174143	08/10/2001	WV	41.0	41		F	08/03/2001	On 11/20/00, pt had upper respiratory infection associated with cough, sore throat, wheezing, low-grade temperature and chills with profuse sweating. She kept getting worse and was hospitalized on 12/29/00. On 1/25/00, she had numbness in hands and feet, trouble walking, drooping on the left side of face with slurred speech, asymmetric smile, numb tongue, blurred vision and trouble with eyelids. She was hospitalized and put on IVIG for 5 days. She is still recovering and taking physical therapy. The follow up states that: I have permanent facila damage (the left side of my face does not move); have visual problems; hand, feet and legs still go numb; also still have lung problems. This shot has left me physically and mentally impaired.			Y	Y	Y	10		Y	N	11/09/2000	11/20/2000	11	Lumbar Puncture	PVT	UNK	Coated aspirin; Lotrel; Paxil; vitamin E		Coronary anomaly			1						1	Chills; Cough; Difficulty in walking; Dysarthria; Facial palsy; Hypoaesthesia; Lung disorder; Pharyngolaryngeal pain; Pyrexia; Upper respiratory tract infection; Vision blurred; Visual acuity reduced; Wheezing	FLU3~MEDEVA PHARMA, LTD.~E71290LA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0174446	08/20/2001	KS	65.0	64		F	08/14/2001	Received Flu shot in upper back side of left arm involving the ulnar nerve on 11/21/00. By morning of 11/23/00, there was severe pain in my left arm and hand with partial paralysis of both and is continuing to present. The pain in my arm had progressed to the point of not being able to sleep. The MD prescribed steroids and ibuprofen but did not help even with wearing a sling. All the various doctors I have been shuffled to, agree that I have ulnar nerve damage but don't seem to have a clue as to how to treat me. The original doctor stated he had never had this happen and had no idea how to treat me. I've had Flu shots for 15 years without even have flu symptoms as a result of the shot! The MRI, I had approx. 2 1/2 weeks ago, dispelled the theory of my ruptured disc that I had done in 1983! When I walked into that clinic on 11/21/00, there was not one thing wrong with me. I was working and didn't even take an aspirin unless my head was falling off. Needless to say, I lost my job and most of the use of my left hand and arm. I have been to more doctors in the last 7 months than I have in my whole life. I was also prescribed Neurontin and finished this medicine even though it kept me light-headed and dizzy until it was finished. It did nothing for the pain nor bring us any closer to a solution. Then he prescribed more Neurontin and Vioxx but taking Neurontin 3 X a day, kept me feeling as if I was walking in the clouds, continually. Then he stopped the Neurontin and prescribed amitriptyline to be taken at bedtime, as it makes you tired. I was referred to an infectious control doctor. Then my regular doctor prescribed Carbamazepine and he wants to do blood work to see if any of these medications have affected my liver or kidneys. My doctor has now put me on Celexa Citalopram Hbr for the next month and he also gave me a prescription for Valium to take before the MRI to calm me down but I did not take this. The other medication made me sick to the point of hanging over the commode several times. Cancelled all my appointments with this doctor because nothing seemed to be doing any good. Follow up: received flu shot in upper back side of left arm involving the ulnar nerve on 11/21/2000. By morning of 11/23/00, there was severe pain in left arm and hand with partial paralysis of both continuing to present.				Y					U	11/21/2000	11/23/2000	2	Never conduction with electrodes X 10 and with needles-showing minimal nerve damage; X-ray of arm; MRI	PVT	PVT	NONE	NONE	Allergies to penicillin and codeine			1						1	Nerve injury; Pain; Paralysis; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0174447	08/20/2001	CA	58.0	57		F		Within 48 hours after the vaccine, I started having joint pains in my hips and shoulders, the pain went down to my elbows, and in after a few weeks the pain moved down to my hands. The pain in my elbows and shoulders has let up but my fingers are getting worse, with some swelling. It is getting difficult to do things like open jars with out alot of pain. I have never had pain like this before. There is nothing listed in the vaccine handout that gives any warnings about arthritis being a side effect of the vaccine.									N	11/01/2000	11/04/2000	3	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Arthralgia; Arthritis; Oedema peripheral; Shoulder pain	FLU3~AVENTIS PASTEUR~U0408EA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0174492	08/21/2001	FL	19.0	19		F	08/19/2001	Pt referred via consultation while she was on the Neurology Inpatient Service for evaluation of her initiation of symptoms following vaccinations during basic training. She presents with concern for development of MS symptoms, post vax, including incidental finding of persistent eosinophilia. She had a nagging toothache for 2-3 months when she joined the US Army on 2/5/01 and it worsened and a tooth abscess was drained 3 days later. A small tooth chip was removed and stitches placed and she was placed on ibuprofen for pain. On 2/12/01, she received 5 shots and within 30 minutes, post vax, she developed a sensation of her right foot falling asleep. This persisted and 2 days later, had increased to now involve her left leg but she was still able to do physical training (even passing a 1-mile run uphill). Over the next 2 weeks, the numbness sensation progressed to involve both hew lower extremities and symmetrically went up to her costal margin bilaterally. She was evaluated with the assessment of paresthesias and suspected neurological disease and neurology consult. She was admitted to the hospital on 3/12/01 but transferred to  another hospital on 3/13/01 to 3/20/01 for increasing symptoms. She was evaluated by neurology and tests. Dx at that time was encephalomyelitis secondary to vaccination. She was treated with high dose steroids. Prior to admission she also complained of headache, nausea and fatigue which almost completely resolved with steroid course. Her paresthesias also diminished although were now confined to her right leg and trunk. She was started on Elavil and Motrin for pain on 4/27/01 and Neurontin and Septra on 4/30/01. She was placed on convalescent leave although during a road march 5-6 weeks after entering basic she developed slurred speech and facial droop and was dx'd with Bell's Palsy. She also had difficulty urinating. The dx of suspected MS was made and she again was treated with IV Solu-Medrol X 5 days and then a 2 week steroid taper. After review of her labs, she was again admitted to the hospital on 7/17/01. During her admission, Allergy/Immunology was consulted to address her vaccine issues and eosinophilia. Summary of symptoms since vaccines: paresthesias X 5 month; headaches X 2 months; fatigue X 5 months; pruritus X 5 months; light-headedness X 1 month; nausea X 3.5 months; intermittent emesis with headache; intermittent Bell's Palsy 4 times. On 8/1/01, was also dx'd with spastic bladder secondary to MS and perennial rhinitis					Y			Y	N	07/22/2001	07/22/2001	0	Lab work on 3/2/01: LFT's, chemistry, CBC, RPR, TSH, B12/folate, FTA-mildly low hgb of 11.6 gm/dL, automated eosinophil % of 4 (nl 0-3; ANC=230) and mild AST elevation of 45. On 3/13/01: CSF studies; MRI head/spine-showed 2 lesions in the CNS and 2 in the spine. On 5/19/01: MRI-showed multiple white matter signal abnormalities in a pattern compatible with multiple sclerosis and also suggestive of active demyelination. On 7/17/01: WBC-5400 cells/mm3, nl hbg, nl plts, increased eosinophil count of 1242 cells/mm, nl chem 7, ESR 15 mm/hr, LDH 567 (313-648), CRP of 0.15 (0.03-5.00nl), albumin 2.8, calcium of 8.1, total protein of 5.6 g/dL. Repeat CBC, after 3 days of IV Solu-Medrol hand no change in eosinophil count; CXR PA/Lateral was nml. Bone marrow biopsy	OTH	UNK		dental abscess	GERD; varicella infection as a child; allergy to sulfa (hives)			1						1	Aspartate aminotransferase increased; Demyelination; Dizziness; Dysarthria; Dysuria; Encephalitis; Eosinophilia; Facial palsy; Fatigue; Headache; Hypocalcaemia; Laboratory test abnormal; Multiple sclerosis; Nausea; Nervous system disorder; Neuropathy; Paraesthesia; Pruritus; Rhinitis; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~UNK~SC~~MENINGOCOCCAL (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~SC~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~IM~~TD ADSORBED (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0174556	08/22/2001	MD	34.0	34		F	08/20/2001	Previously healthy 34 year old black female has had progressively worsening neuro, GI and muscular skeletal symptoms since receiving 7 Anthrax vaccines. After 1st shot, had migraines with 15 to 22 medical visits from 3/19/98 to 6/11/01. She has chronic fatigue; was a runner prior to 2/98 but now barely able to run/walk 1/4 mile. Fibromyalgia, generalized with migratory muscle spasm and pain poorly controlled. Elavil recommended on 7/12/01. Paresthesias with migratory hypesthesia. Anemia with Sickle Trait. GERD with trial of Prilosec with partial relief. She has recurrent symptoms of Vaginitis; self treated with OTC at least 10-12 times/year; candida or bacterial vaginosis documented in chart, never prior to 1998. Situational stress; fear of loss of health, job, quality of life. Anthrax vaccine temporarily exempted X 1 year starting 8/01. She also has GI pains.								Y	N	12/07/2000			ANA, Anti-DS DNA, ENA, CK-neg/nml; ESR-mildly elevated; Neurologic exam-nml; Hgb A1-low; iron studies-nml; MRI	MIL	MIL	Prilosec 20mg; Elavil 10mg; Imitrex prn	NONE	Aspirin causes hives; sulfa drugs causes facial itching and rash and penicillin causes hives/rashes. Cesarean section in 1991.			1						1	Abdominal pain; Anaemia; Anxiety; Blood disorder; Fatigue; Fibromyalgia; Gastrooesophageal reflux disease; Hypoaesthesia; Migraine; Muscle spasms; Paraesthesia; Red blood cell sedimentation rate increased; Vaginal infection	ANTH~EMERGENT BIOSOLUTIONS~~7+~SC~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0174703	08/27/2001	VA				U		Six years ago the patient received an influenza virus vaccine 1987-88 formula (manufacturer unknown) and developed a reaction at the injection site described as ulceration. On follow up, the physician noted that he did not know the patient, nor was he aware of any such reaction in his patient population.									U				UNK	OTH	OTH	UNK	UNK	UNK		8932790115	1						1	Injection site reaction; Skin ulcer	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0174704	08/27/2001	NC	52.0			F	12/27/2000	The patient reported that she received an injection of 1997-1998 formula influenza virus vaccine (manufacturer unknown) in 1997 and subsequently developed shingles. The patient recovered.									Y				UNK	OTH	OTH	UNK	UNK	UNK	Bell's Palsy~Influenza (Seasonal) (FluShield)~~54.00~In Patient	HQ5045119DEC2000	1						1	Herpes zoster	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0174766	08/28/2001	FL				M		A male pt reported that he received a dose of Adenovirus Vaccine Live Oral Type 4, Adenovirus Vaccine Live Oral Type 7, Poliomyelitis virus and Influenza Bivalent vaccines on 2/4/75 when he was in the military. The pt noted that his medical records indicate that a couple of days after vaccination, he developed nose bleeding and neck adenopathy. He also reported that he has been dx'd with chronic Hepatitis C. The reporter indicated that his neck is swollen to this day. Additional information received on 7/11/00 included the pt's medical records which indicated that the pt had recurrent nose bleeds from his right nostril, his throat was inflammed and had neck adenopathy.									U	02/04/1975			UNK	MIL	MIL	UNK	UNK	UNK		HQ8156805JUL2000	1						1	Epistaxis; Hepatitis C virus; Lymphadenopathy; Pharyngitis	ADEN~PFIZER\WYETH~~UNK~PO~MO~ADENOVIRUS (TYPE 4, NO BRAND NAME)~1|ADEN~PFIZER\WYETH~~UNK~PO~MO~ADENOVIRUS (TYPE 7, NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|OPV~PFIZER\WYETH~~1~PO~MO~POLIO VIRUS, ORAL (ORIMUNE)~1	USA		Influenza
0174767	08/28/2001	PA	25.0	24		F	01/16/2001	A nurse reported that a female, now 33 years of age, received an injection of 1992-1993 formula influenza virus vaccine in 1992 and subsequently, developed the flu. She recovered after 2 days. (This pt developed a swollen tongue, a painful knot in her neck, numb lips, pallor and felt strange following a recent receipt of Flu Shield 2000-2001 formula; see MCN HQ5928515JAN2001).									Y	01/01/1992			UNK	OTH	OTH	UNK	UNK	UNK		HQ5940615JAN2001	1						1	Influenza	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0174768	08/28/2001	OH	46.0	45		F	10/02/2000	A female, now 54 years of age with a history of allergy to eggs since childhood, reported that she received an injection of 1992-1993 formula influenza virus vaccine in 1992 and subsequently, developed a fever of 104F and generalized hives. She also developed an injection site reaction characterized by severe swelling and redness. She was seen by the physician and treated with an injection of an unidentified medication. She recovered.				Y					Y	01/01/1992	01/01/1992	0	UNK	OTH	OTH	UNK	UNK	Food allergy		HQ9125328JUL2000	1						1	Injection site erythema; Injection site swelling; Pyrexia; Urticaria	FLUX~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0174769	08/28/2001	VA	52.0	51		F	08/23/2000	A 52 year old female reported that she received 1994-1995 formula influenza virus vaccine and subsequently, developed a local reaction. She reported that it was felt that the reaction may have been related to the eggs.									U	01/01/1994	01/01/1994	0	UNK	OTH	OTH	UNK	UNK	Hypersensitivity NOS		HQ9960217AUG2000	1						1	Hypersensitivity	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0174852	08/31/2001	VA	27.0	27		F	11/21/2000	At 1:35 pm on 11/17/00, this patient arrived to the health dept complaining of hives and itching of the upper torso. Symptoms progressed. The itching intensified, restless. Complains of throat discomfort. Wheezing noted. The patient was transported to the ER via rescue unit. She received Epinephrine, Benadryl, breathing treatment, and Prednisone.				Y					Y	11/17/2000	11/17/2000	0	No Test.	PUB	UNK	PPD, Connaught, lot #C0152AA, intradermal left forearm.	NONE	Asthma			1						1	Discomfort; Pruritus; Restlessness; Urticaria; Wheezing	FLU3~PFIZER\WYETH~400873~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~SMITHKLINE BEECHAM~335294~2~IM~RA~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0162499	09/05/2001	IL	71.0	71		M	04/06/2001	A healthcare professional reported that a patient received an injection of Pnu-Imune 23 and Fluzone (Aventis Pasteur Inc.) on 11/08/00. Subsequently, the patient developed a local reaction which the reporter did not describe at the site of Pnu-Imune 23 administration. No further info was available at the date of this report. This is 1 of 3 patients who experienced this event following receipt of Pnu-Imune-23 lot 466-440. Follow up info received from the physician on 03/27/01 indicated that the patient was 71 year old male. He was seen by the physician and recovered.				Y					Y	11/08/2000			UNK	PVT	PVT	Atenolol, Dyazide	NONE	UNK		HQ6756202FEB2001	1						2	Unevaluable event	FLU3~AVENTIS PASTEUR~~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~466440~1~IM~RA~PNEUMO (PNU-IMUNE)~2	USA	Emergency room visit	Influenza
0174940	09/05/2001	VA				U	02/21/2001	Within 24 hours of vax, pt developed a severe injection site reaction characterized by swelling, redness and tenderness. No further info was available at date of this report. Manufacturer's Comment: The reporter indicated that 5 pts experienced this event; howeer, they are not presently identifiable. Addtl reports will be generated when identifying info is provided.									U				UNK	PVT	OTH	UNK	NONE	UNK		HQ4634808DEC2000	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~463013~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0174941	09/05/2001	AL	37.0	37		M	06/29/2001	The day following vax pt developed a fever of 102F and an injection site reaction at the site of Pnu-Imune-23 administration which the reporter did not describe. On 12/7/00 pt was seen by MD and treated with Motrin, Benadryl, Tylenol and applications of cold compresses. A copy of this report has been forwarded to Aventis Pasteur Inc., manufacturer of Fluzone. Follow-up info recvd 6/18/01 indicated that the pt received Pnu-Imune 23 on 12/6/00. He recovered.									Y	12/06/2000	12/06/2000	0	UNK	PVT	OTH	Allergens	NONE	UNK		HQ4720111DEC2000	1						1	Injection site reaction; Pyrexia	FLU3~AVENTIS PASTEUR~UO421AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466786~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0174942	09/05/2001	IL	66.0	66		F	12/20/2000	A nurse reported that pt received pneumococcal (manufacturer unk) and 1993-94 formula influenza (manufacturer unk) vaccines in 1993 and subsequently developed an injection site reaction characterized by redness and soreness. She recovered.									Y	07/01/1993	07/01/1993	0	UNK	OTH	OTH	UNK	UNK	UNK		HQ3065401NOV2000	1						1	Injection site erythema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~~1~~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0174943	09/05/2001	AR	67.0	67		U	02/09/2001	Two days post vax the pt developed an injection site reaction at the Pnu-Imune 23 site described as a large red wheal 3 inches in diameter that became sore radiating down to the elbow. Note: This is 1 of 2 pts reported by the same reporter. See HQ6352724JAN2001 for the report on the other pt.									U	01/20/2001	01/22/2001	2	UNK	OTH	OTH	Prilosec	NONE	UNK		HQ6999308FEB2001	1						1	Injection site erythema; Injection site pain; Urticaria	FLU3~PFIZER\WYETH~4008205~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~470593~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0174944	09/05/2001	PA	88.0	88		F	03/21/2001	Two days post vax pt developed an injection site reaction characterized by redness, pain, swelling and itching at the site of Pnu-Imune 23 administration. The MD instructed pt to treat with Motrin and applications of ice. That same day she was seen in ER and treated with an unspecified antibiotic. On 11/2/00, pt was seen by MD who noted some improvement of her symptoms. The pt had previously recvd an injection of Pnu-Imune 23 in 1993. This is 1 of 4 pts from this facility who experienced an adverse event following receipt of 2 different lots of Pnu-Imune 23. Follow-up info recvd from MD on 3/20/01 indicated the pt recovered.				Y					Y	10/26/2000	10/28/2000	2	UNK	PVT	OTH	ASA, Lanoxin, Levoxyl, Miacalcin, vitamins	NONE	UNK		HQ7135212FEB2001	1						1	Injection site erythema; Injection site pain; Injection site swelling; Pruritus	FLU3~MEDEVA PHARMA, LTD.~E64710HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~474938~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0174945	09/05/2001	TX	65.0	65		F	02/12/2001	A nurse reported that a 65 year old female received an injection of Pnu-Imune 23 and Fluzone (Aventis Pasteur Inc.) vaccines on 11/13/00. Within 24 hours of vaccine administration, the patient developed an injection site reaction characterized by redness and swelling. The specific sites of vaccine administration were not reported. This is 1 of 2 patients from this facility who experienced an adverse reaction following receipt of Pnu-Imune 23 lot 469-133.									U	11/13/2000	11/14/2000	1	UNK	PUB	OTH	UNK		UNK		HQ6774702FEB2001	1						1	Injection site erythema; Injection site oedema; Injection site erythema; Injection site swelling	FLU3~AVENTIS PASTEUR~U0410AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~469133~UNK~SC~~PNEUMO (PNU-IMUNE)~1|FLU3~AVENTIS PASTEUR~U0410AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~469133~UNK~SC~~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0174946	09/05/2001	NY	72.0	72		F	03/21/2001	A nurse reported that a 72 year old female received an injection of Pnu-Imune 23 and Influenza virus vaccine (manufacturer unknown) on 11/03/00. Subsequently,the patient developed cellulitis at the site of Pnu-Imune 23 administration. She was treated with Advil , Benadryl, and applications of warm compresses. This is 1 of 3 patients from this facility who developed an injection site reaction following receipt of Pnu-Imune 23 lot 470-588. Follow-up info received from the physician on 03/14/01, indicated that the patient experienced the adverse event on 11/04/2000. She was seen by the physician and recovered.				Y					Y	11/03/2000	11/04/2000	1	UNK	PVT	OTH	Hydrochlorothiazide, Premarin, Prinivil.	NONE	UNK		HQ6540629JAN2001	1						1	Cellulitis; Injection site reaction	FLU3~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~470588~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0174947	09/05/2001	CA				F	04/19/2001	A female reported that she received Pnu-Imune 23 and Influenzae virus vaccines on 12/02/00. That same day, she experienced a headache, feeling sick to the stomach, weakness, dizziness, and a stiff neck. She also experienced severe pain from her right shoulder extending down her hand and up to the side of her neck to her skull. In addition, her hand became purple in color and she developed an injection site reaction characterized by redness and warmth at the site of Pnu-Imune 23 administration. She was seen by a physician who reportedly attributed the events to a reaction to the Pnu-Imune 23 injection.									U	12/02/2000	12/02/2000	0	UNK	OTH	OTH	UNK	NONE	UNK		HQ4797513DEC2000	1						1	Asthenia; Dizziness; Headache; Injection site erythema; Injection site warmth; Musculoskeletal stiffness; Nausea; Pain; Shoulder pain; Skin discolouration	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0174948	09/05/2001	NJ	57.0	57		F	01/25/2001	A 57 year old female received Pnu-Imune 23 and Flu-Shield (2000- 2001 Formula) on 12/12/00. The next day, she developed an injection site reaction characterized by redness, swelling, and tenderness below the Pnu-Imune 23 injection site.									U	12/12/2000	12/13/2000	1	UNK	PVT	PVT	NONE	NONE	UNK		HQ4932515DEC2000	1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4008188~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~463015~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0174949	09/05/2001	GA	43.0	43		F	05/03/2001	A 43 year old female reported that she received Pnu-Imune 23 and Influenza virus vaccine (manufacturer unknown) on 12/14/00. Within a few hours of vaccine administration, she developed an injection site reaction characterized by a large hive that swelled to the size of a baseball, itching, and redness. The reporter indicated that both vaccines were administered in the left deltoid.									U	12/14/2000	12/14/2000	0	UNK	PVT	OTH	Allegra, Desogen Ciba-Geigy, Detrol, Inderal, Prozac, Trazodone.	NONE	UNK		HQ5024519DEC2000	1						1	Erythema; Pruritus; Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0174950	09/05/2001	UT	55.0	55		F	06/05/2001	A medical assistant reported that a 55 year old female received an injection of Pnu-Imune 23 on 01/04/01. The following day, she developed an injection site reaction characterized by tenderness, swelling, redness, and warmth. She was treated with Benadryl and applications of moist heat. The patient recovered by 01/09/01. This is 1 of 2 patients from this facility who experienced this event following receipt of Pnu-Imune 23 lot 466-440. Follow-up info received from the physician on 05/29/01, indicated that the patient received Pnu-Imune 23 and Fluzone vaccines on  01/04/2001. The patient developed the injection site reaction at the site of Pnu-Imune 23 administration.									Y	01/04/2001	01/05/2001	1	UNK	PVT	PVT	Ogen, Provera	NONE	UNK		HQ5885112JAN2001	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Injection site warmth	FLU3~AVENTIS PASTEUR~U0334AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466440~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0174951	09/05/2001	AR				U	02/09/2001	A pharmacist reported that a pt (age and gender unspecified) received injections of Pnu-Imune 23 and Flu Shield (2000-2001 Formula) on 1/19/01. On an unspecified date, the pt developed an injection site reaction at the Pnu-Imune 23 site described as a large red wheal, 3 in diameter that became sore, radiating down to the elbow. Note: This is 1 of 2 pts reported by the same reporter. See HQ6999308FEB2001 for the report on the other pt.									U	01/19/2001			UNK	OTH	OTH	Allegra, Premarin, Synthroid	NONE	UNK		HQ6352724JAN2001	1						1	Injection site erythema; Injection site pain; Urticaria	FLU3~PFIZER\WYETH~4008205~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~470593~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0174952	09/05/2001	DC	43.0	42		M	04/12/2001	A physician reported that a male pt received an injection of Pnu-Imune 23 and subsequently, developed tachycardia and a fever of 99.8F. He also developed an injection site reaction characterized by swelling and warmth. His blood pressure was 112/74. Follow-up information received from the physician on 4/3/01, indicated that a 43 year old male received Pnu-Imune 23 and Fluvirin (Evans) vaccines on 12/5/00. The following day, he developed tachycardia, fever and an injection site reaction at the site of Pnu-Imune 23 administration. The pt recovered.									Y	12/05/2000	12/06/2000	1	NONE	PVT	OTH	Albuterol, Allegra, Trazodone, Wellbutrin	UNK	Anaphylactic reaction; Urticaria NOS		HQ4658308DEC2000	1						1	Hypotension; Injection site reaction; Injection site swelling; Injection site warmth; Pyrexia; Tachycardia	FLU3~MEDEVA PHARMA, LTD.~865610HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0174953	09/05/2001	AL	70.0	70		F	04/17/2001	A physician reported that a 70 year old female received Pnu-Imune 23 and Fluzone vaccines on 11/13/00. A few minutes, post vax, the pt developed arthritis type symptoms described as arthralgia and myalgia of both arms and effusion of her right shoulder. On 11/17/00, she was seen by the physician who tapped her shoulder and treated her with ibuprofen and Tylenol. The reporter stated that blood work showed an elevated ANA and some of her CBC was abnormal. The reporter also indicated that this was a new pt and blood levels could have been elevated prior to vaccination. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Pnu-Imune 23 (lot 466786).									U	11/13/2000	11/13/2000	0	ANA-elevated; Full blood count-abn	PVT	OTH	Acetylsalicyclic acid, calcium, Levothyroxine, Prempro, Tylenol, Verapamil, Vitamins	NONE	UNK		HQ4718711DEC2000	1						1	Antinuclear antibody positive; Arthralgia; Joint effusion; Laboratory test abnormal; Myalgia	FLU3~AVENTIS PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~466786~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0174954	09/05/2001	TX	63.0	63		F	02/12/2001	A nurse reported that a 63 year old female received Pnu-Imune 23 and Fluzone vaccines on 11/13/00. Within 24 hours, post vax, the pt developed vomiting, general myalgia and alternating feelings of hot and cold. She also developed an injection site reaction characterized by redness and swelling. The specific sites of vaccine administration, were not specified. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Pnu-Imune 23 (lot 469133).									U	11/13/2000	11/14/2000	1	UNK	PUB	OTH	UNK	UNK	Multiple Sclerosis		HQ3945120NOV2000	1						1	Feeling cold; Hot flush; Injection site erythema; Injection site swelling; Myalgia; Vomiting; Injection site erythema; Injection site swelling; Myalgia; Pyrexia; Vomiting	FLU3~AVENTIS PASTEUR~U0410AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~469133~UNK~IM~~PNEUMO (PNU-IMUNE)~1|FLU3~AVENTIS PASTEUR~U0410AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~469133~UNK~SC~~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0174955	09/05/2001	CO	79.0			F	01/30/2001	A nurse reported that a 79 year old female received Pnu-Imune 23 and Fluzone vaccines on 10/26/00. The following day, she developed pain, swelling and redness of her joints. The pt was dx'd with polyarthritis.									U	10/26/2000	10/27/2000	1	UNK	PVT	PVT	Premarin, Synthroid, Voltaren, Zoloft	UNK	UNK		HQ3356708NOV2000	1						1	Arthralgia; Arthritis; Joint swelling; Polyarthritis	FLU3~AVENTIS PASTEUR~U0402AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~470588~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0174956	09/05/2001	NY	72.0			F	03/21/2001	A nurse reported that a 72 year old pt received an injection of Pnu-Imune 23 and influenza virus vaccine on 11/1/00. Subsequently, the pt developed cellulitis at the site of Pnu-Imune 23 administration. The pt was treated with an unspecified antibiotic. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23 (lot 470588). Follow-up information received from the physician on 3/14/01, indicated that a 72 year old female developed the adverse event on 11/2/00. She was seen by the physician and recovered.				Y					Y					PVT	OTH	Altace, Vioxx, Xanax, Zyrtec	NONE	UNK		HQ3380208NOV2000	1						1	Cellulitis; Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~470588~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0174957	09/05/2001	OH	75.0	75		M	02/08/2001	A nurse reported that a 75 year old male received Pnu-Imune 23 and Fluvirin vaccines on 10/24/00. The reporter stated that the vaccines were administered after being mixed in the same syringe. Approx. 6 hours later, the pt developed a fever, nausea and swelling at the injection site. He recovered by 10/27/00.									Y	10/24/2000	10/24/2000	0	UNK	OTH	OTH	NONE	UNK	UNK		HQ3696214NOV2000	1						1	Injection site swelling; Nausea; Pyrexia	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0174958	09/05/2001	VA				M	02/07/2000	A physician reported that a male pt received Pnu-Imune 23 and 1999-2000 formula influenza virus vaccines on 10/19/99. On 10/20/99, he developed cellulitis and was seen in the physician's office. He was prescribed an unspecified antibiotic. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune 23 (lot 459040); the other was serious. See related MCN HQ3303122OCT1999. Additional information received from the physician on 12/7/99, indicated that the pt recovered.				Y					Y	10/19/1999	10/20/1999	1	UNK	PVT	OTH	NONE	NONE	UNK		HQ3303322OCT1999	1						1	Cellulitis; Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~459040~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0174959	09/05/2001	RI	58.0	58		F	05/10/2002	A 58 year old female received an injection of influenza virus vaccine in 10/76. One year, post vax, she developed hypersensitivity to the following; sulfa products, penicillin, Floxin, Cipro, codeine, clindamycin, Macrobid, generic Klonopin, blue dye, red dye #40, yellow dye FC #5 and #6, eggs, beef, bacitracin, proparacaine, lidocaine, Tobrex, fluoracaine, Acular, Ocuflox, Vexol and chlorine in the drinking water. Her hypersensitivity symptoms include: nausea and diarrhea. FOLLOW-UP information received fromthe patient on 08/27/01, indicated that she also developed a hypersensitivity to Bactorban and band-aids glue. FOLLOW-UP informationreceived from the patient on 05/09/02 indicated that her symptoms have not related.									U	10/01/1976	10/01/1977	365	UNK	PUB	PUB	Klonopin, Lopressor	NONE	Mastectomy NOS		HQ2638128JUN2001	1						1	Diarrhoea; Nausea	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0170015	09/11/2001	FL	58.0			U	07/26/2001	On 12/01/00, right leg and foot was numb, tingly, pain in knee with purple spots to knees. Went to the doctor and was admitted to hospital on 12/20/00. Pt had pain in both legs, couldn't walk and was dx'd with vasculitis; cause: flu shot. I have been to a doctor every week since this time; plus to therapy 3 X a week. Now in July,2001, I am still seeing 3 doctors. follow up Information received 10/18/02 stated, My condition has stablized, leaving me still in lots of pain in feet and legs, still with cold tingling, at times numbness, still have irregular heart beat with a-fib. I must take medication for these ailments that total over $900 per month.					Y				U	11/29/2000	11/30/2000	1	While in hospital X 2 every test doctors could think of. ANCA test showed most, Sed Rate	PVT	OTH		NONE	Hypertension-controlled			1						2	Blood pressure increased; Dehydration; Hypoaesthesia; Livedo reticularis; Mononeuritis; Pain in extremity; Peroneal nerve palsy; Red blood cell sedimentation rate increased; Renal failure; Thrombosis; Type IV hypersensitivity reaction; Vasculitis; Abasia; Antinuclear antibody positive; Arthralgia; Ecchymosis; Paraesthesia; Vasculitis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4008183~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0175218	09/11/2001	KY	49.0	49		F	03/01/2002	A nurse reported that a 49 year old female NP received Flu Shield (2000-2001) vaccine on 11/3/00. The NP stated that the shot felt like a normal shot; however, within a few days, she developed muscle tenderness at the injection site. The soreness in this area continued and she received physical therapy to the area in 12/00. She was treated with rofecoxib (Vioxx) for the discomfort. On 1/4/01, an MRI was done which revealed muscle tears and irritation to posterior aspect of left rotator cuff-tendonosis. The nurse practitioner stated that this was the same area from where she had been experiencing discomfort since the immunization. She denied other injury to the area. This report was considered serious since muscle injury and injection site pain were considered Medically Important in this case. No additional information was available as of the date of this report. no additional info was added with this follow up. On 02/21/02, follow up was recieved from the reporter. The pt was continued to experience pain. On 09/06/01, arthroscopy of the shoulder was performed; the surgeon shaved bone and repaired the rotator cuff. She was hospitalized for 23 hrs. The pt gradually developed increased range of motion and slowly recovered. She is currently doing well.				Y					U	11/03/2000	06/04/2001	213	6/4/01-Nuclear MRI-muscle tears and irritation to posterior aspect of left rotator cuff-tendonosis	PUB	OTH	NONE	NONE	UNK		HQ5486904SEP2001	1						1	Injection site pain; Injury; Myalgia; Rotator cuff syndrome	FLU3~PFIZER\WYETH~U0421AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0175422	09/17/2001	FL	66.0	59		F		Symptoms began approximately 7 - 14 days after taking the injections. First symptoms were tingling in her feet and legs which quickly traveling to my hands, arms and most of my body. This followed with a weakness in my left knee which gave me a feeling that it would collapse, my right ear feeling clogged with water, every little bump or touch went right through me. Left for Florida on 11/23, and was seen by a vascular doctor who ordered an MRI of the lower spine and an arterial doppler which were negative. Went to a neurologist and initially had a lyme titer, Western Blot was positive while the ELISA was negative. Ana was positive on one occasion and then negative. Electrodiagnostic studies were performed showing slow nerve conduction velocities with absent reflexes. CBC, sed rate, thyroid profile, random glucose, B12, folate acid, VDRL, Lyme's screen, conduction velocities (electromyograms) were all performed. Started on Doxycycline. Referred to Infectious Disease doctor and had a lumbar puncture on 01/26/95 followed by motor problems and pain which lasted some 3-4 weeks. Returned to NJ and was re-examined by my neurologist there who determined polyradiculoneuropathy. He started Elavil which I could not tolerate. I have all the records from all the doctors with test, dates, and results. I still suffer with constant pins and needles which lately has become more noticeable and annoying, with stronger throbbing radiating from the feet to the legs. Most of the other symptoms have all disappeared.									N	11/07/1994	11/18/1994	11	MRI of the lower spine and an arterial doppler which were negative. Went to a neurologist and initially had a lyme titer, Western Blot was positive while the ELISA was negative. Ana was positive on one occasion and then negative. Electrodiagnostic studies were performed showing slow nerve conduction velocities with absent reflexes. CBC, sed rate, thyroid profile, random glucose, B12, folate acid, VDRL, Lyme's screen, conduction velocities (electromyograms) were all performed. Lumbar puncture on 01/26/95.	PVT	OTH	Inderal LA					1						1	Ear disorder; Hemiparesis; Nervous system disorder; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0176131	09/17/2001	KS				M	09/12/2001	Following vax, the pt developed double pneumonia. The pt also alleges that he was hospitalized and as a result of the pneumonia has experienced a loss of respiratory capacity requiring daily oxygen use. No further information has available at the date of this report. Additional info received on 9/27/01, indicated that the pt received an injection of Flu Shield (1997-1998 Formula). Therefore, this case has been canceled and a new case was created for Flu Shield (1997-1998 Formula). See HQ6758304OCT2001.					Y				U	01/14/1998	02/20/1998	37	UNK	OTH	OTH	UNK	UNK	immune system disorder		HQ5852111SEP2001	1						2	Difficulty in walking; Dyspnoea; Pneumonia; Respiratory disorder; Hypoxia; Pneumonia; Respiratory disorder	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0175571	09/21/2001	VT	4.0	7		F	09/19/2001	6 x 9 inch irregular shaped red, swollen area right upper arm.									Y	09/17/2001	09/18/2001	1		PVT	PVT		NONE	NONE			1						1	Injection site erythema; Injection site oedema	DTAP~SMITHKLINE BEECHAM~A997A2~5~IM~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UO598AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~CONNAUGHT LTD.~T0785~4~IM~LA~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~1516K~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0175768	09/27/2001	CA	50.0	50		F	07/21/2001	Pt's left arm was sore and with a walnut-sized lump X 10-13 days and disappeared. Pt had a rash on body, sores in mouth, joint and muscle pain. She was seen at Urgent Care X 2 then saw a dermatologist X 3 months. Vasculitis due to influenza was medical Dx. Pt's left and right ankles were tender, scarred and stinging. Buspar was taken.			Y	Y				Y	N	11/01/2000	11/02/2000	1	CBC; U/A; Sigmoidoscopy; Kidney Scan	PVT	UNK	Levothyroxine	NONE	NONE			1						1	Arthralgia; Injection site mass; Injection site pain; Mouth ulceration; Myalgia; Pain; Rash; Scar; Vasculitis	FLU3~PFIZER\WYETH~4008713~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Disabling	Influenza
0176038	10/04/2001		35.0			F		A report was received from a health professional on 09/14/01, concerning a 35 year old female patient who was hospitalized due to anaphylaxis after receiving a Fluvirin vaccine on 09/11/01. On 09/11/01, the patient experienced anaphylaxis including redness / itching, difficulty in breathing, and chest pain. 10 minutes after receiving a Fluvirin vaccination. Therapeutic measures taken as a result of this event included Diphenhydramine 50 mg IV and Epinephrine 1:1000, which were administered IV. The patient then became blue, developed red welts on her chest and extreme whiteness of extremities, with no breathing for about 30 seconds. Oxygen was administered and the patient was admitted to the hospital on 09/11/01, with symptoms abating but continuing through. The patient recovered on 09/13/01, and was to be discharged from the hospital on 09/14/01. The reporter has assessed the relationship of the study medication to the event as possible.			Y		Y				U	09/11/2001	09/11/2001	0		UNK	UNK			Allergy to Sulfa drugs and Metoclopramide.		PJP2001002790	1						1	Anaphylactic reaction; Apnoea; Chest pain; Cyanosis; Dyspnoea; Erythema; Pallor; Pruritus; Urticaria	FLU3~EVANS VACCINES~E00931HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0176071	10/05/2001	GA	51.0	51		F	09/29/2001	Pain (severe) and tenderness at injection site. Arm is swollen and tender from elbow to neck. No yet recovered.									N	09/26/2001	09/27/2001	1		PUB	PVT	Ziac 10mg every day	NONE	NONE			1						1	Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U0675BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176072	10/05/2001	MO	50.0	50		F	09/27/2001	Pt noticed redness, swelling and soreness last PM.									Y	09/26/2001	09/26/2001	0	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U0590AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176073	10/05/2001	PA	3.5	3		F	10/04/2001	Pt got flu shot on 10/3/01 at 11:00 and then developed a fever of 105F (R) at 03:00. Treated with Motrin and Tylenol and the fever went down to 101F by 08:00. The pt had emesis X 1 at 08:00.  A follow up report received 10/10/2001 adds: Child has recovered as of 10/08/01.									Y	10/03/2001	10/04/2001	1		PVT	PVT	Intal MD; Serevent MDI; Flovent MDI; Albuterol Syrup	Cough and cold; recovering X 2 weeks	RAD; Allergic wheal/flare Rxn to DTAP/IPV at 18 months	Wheal/flare~DTaP (no brand name)~4~1.00~In Patient		1						1	Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U0599BA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176117	10/08/2001	NY	50.0	49		F	10/05/2001	Two days, post vax, pt complained of shoulder pain and hip pain which she noticed the morning after vaccines were received. Three days, post vax, on 10/5/01, hip and shoulder pain is unchanged. Injection site is red, hard and swollen.									Y	10/02/2001	10/04/2001	2		OTH	OTH	Plaquenil; Synthroid; Zoloft		History of Lupus since 1998			1						1	Arthralgia; Injection site erythema; Injection site induration; Injection site swelling	FLU3~SANOFI PASTEUR~U0669AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176128	10/09/2001	AZ	29.0	29		F	10/05/2001	A couple of minutes, post vax, she came back to Employee Health and said it felt like her throat was swelling. She was taken to ER and given IV with epinephrine Medrol dose-pack; Pepcid; Benadryl and Cortisone. A follow up report received 10/11/2001 adds: Taken to the ER of hospital for evaluation of rapid onset of swelling of the throat after immunization for influenza and 2nd shot in series of Hep B immunization. ER chart states Dx as acute angiodema 2ndary to Hep B vaccine.				Y					Y	10/04/2001	10/04/2001	0	NONE	OTH	PVT	Singulair; Prozac; Claritin; Coumadin	NONE	Removal of melanoma and lymph nodes; Pulmonary embolism 1/00	Rash~Hep B (no brand name)~2~21.00~In Patient		1						1	Angioneurotic oedema; Pharyngeal oedema	FLU3~SANOFI PASTEUR~U0592AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0755L~2~IM~RA~HEP B (FOREIGN)~1	USA	Emergency room visit	Influenza
0176131	10/10/2001	KS				M	10/08/2001	A male patient alleges that he received an injection of Flu Shield (1997-1998 Formula) on 01/14/98. Approximately 4 hours post-vaccination, the patient stated that he was gasping for breath and could hardly walk. He reportedly was seen in an emergency room on 02/20/98 and diagnosed with double pneumonia. At that time, the patient reported he was hospitalized and received unspecified treatment. The patient also alleges that as a result of the pneumonia, he has suffered a loss of respiratory capacity requiring daily oxygen use.					Y				U	01/14/1998	02/20/1998	37	UNK	OTH	OTH	UNK	UNK	Hypogammaglobulinaemia nos; Lung disorder nos.		6758304	1						1	Difficulty in walking; Dyspnoea; Pneumonia; Respiratory disorder; Hypoxia; Pneumonia; Respiratory disorder	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0176168	10/10/2001	PA	76.0	76		F	09/26/2001	The pt complained of malaise, dizziness, diaphoresis, dyspepsia, cephalgia, extreme fatigue, general myalgia.									N	09/19/2001	09/20/2001	1		PVT	PVT	Zantac, Toprol, EC ASA, Celebrex	NONE	GERD, obesity, migraine headache, DJD, idiopathic ventricular ectopy			1						1	Dizziness; Dyspepsia; Fatigue; Headache; Hyperhidrosis; Malaise; Myalgia	FLU3~SANOFI PASTEUR~U0559BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176169	10/10/2001	MN	51.0	51		F	09/30/2001	The pt complained of sore arm from 11/00 through 3/01 and occasionally still sore at the injection site. The pt states that she can no longer reach her right arm across her back and up to her left shoulder. She states she used to be able to do this. A follow up report received 10/12/2001 adds: Pt continues to have diminished range of motion when reaching behind her back to scratch her left shoulder blade. Has not explored with her physician the usefulness of seeing a physical therapist who could suggest range of motion exercises. Pt was reassured that pts do complain after having all type injections.									N	11/11/2000	11/11/2000	0	NONE	PVT	OTH	Insulin, Humalog	NONE	insulin dependent diabetes			1						1	Hypokinesia; Injection site pain	FLU3~AVENTIS PASTEUR~U0410AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176228	10/11/2001	WA	19.0	19		M	10/03/2001	Guillain-Barre' Syndrome.			Y	Y	Y	30	Y	Y	U	12/01/2000	05/01/2001	151		MIL	MIL		NONE	NONE			1						1	Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0176229	10/11/2001	IN	33.0	33		F	10/01/2001	Within one to two weeks after receiving the Flu shot I started to become easily fatigued and progressively weaker. The I started to experience numbness and tingling to my extremities (hands and feet). By December 1999, I got to a point that I was unable to hold up my own body weight without the assist of another person or a stationary object. I began having muscle spasms that started in my legs and progressed up my entire body including my head. I still continue to experience adverse reactions.					Y	3			U	10/16/1999	12/28/1999	73	CBC; Sed rate; Electrolytes; Antinuclear antibodies serology; CPK; LP; MRI of head and spine; EMG; Thyroid; SGOT; T3, T4, ALT; Copper test; Anti-thyroid Antibodies-all results nml.	OTH	OTH	Antihistamines, Advil	NONE	Allergies-Sinus	Weakness and fatigue~Influenza (Seasonal) (Fluzone)~1~29.00~In Patient		1						1	Asthenia; Fatigue; Gait disturbance; Guillain-Barre syndrome; Muscle spasms; Paraesthesia	FLU3~CONNAUGHT LABORATORIES~U0108CA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0176237	10/11/2001	CA	42.0	42		M	10/10/2001	The pt experienced rash (hives) everywhere. A follow up report received 10/18/2001 adds: Pt reports he had same day response of blotchy-looking rash which was hot to touch and eventually covered most of his skin. He saw a physician who recommended Benadryl 150 mgs at HS, which he took until 10/16/01. His skin condition has almost cleared.									Y	10/03/2001	10/03/2001	0		PVT	OTH	Zoverax, Lipitor, Chinese herbs		AIDS			1						1	Rash; Rash macular; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0176238	10/11/2001	IL	64.0	64		M		The pt experienced a fever for approximately 24 hours with a headache.									Y	10/01/2001	10/02/2001	1	NONE	PVT	UNK	Lipitor		elevated cholesterol			1						1	Headache; Pyrexia	FLU3~SANOFI PASTEUR~U0675AB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~218A6~UNK~IM~RA~HEP A + HEP B (TWINRIX)~1|PPV~MERCK & CO. INC.~1448K~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1|RAB~NOVARTIS VACCINES AND DIAGNOSTICS~286011~UNK~SC~LA~RABIES (RABAVERT)~1|TD~SANOFI PASTEUR~U0463AA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0176271	10/12/2001	OK	5.0	5		F	09/14/2001	08/15/2001 onset joint pain wrists, ankles and back pain. Was seen by PMD X 2. 08/30/2001 seen at ER for severe joint pain. Mom reports told could be rheumatoid arthritis or possibly reactive from MMR. Has appointment 09/17/2001 with pediatric Rheumatologist. Mom reports fever off and on. On moprossyn bid.				Y					N	08/13/2001	08/15/2001	2		PUB	PVT	NONE	NONE	NONE		OK0148	1						1	Arthralgia; Back pain; Rheumatoid arthritis	DTAP~SMITHKLINE BEECHAM~991A2~5~IM~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~T08412~4~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0156L~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0169668	10/15/2001	CA	25.0			M	10/10/2001	It was reported that the patient is a 25 year old with no recent history of travel for the past six months, but prior to that has traveled back to Ecuador intermittently and has traveled to Malaysia, Indonesia, Thailand, Singapore, and Japan in the past. The patient was reportedly vaccinated on 04/27/01, with Yellow fever. Concomitantly vaccinated with Fluzone and Poliovax. On 04/29/01, about 48 hours later the patient developed the onset of symptoms of fever, gastrointestinal symptoms and severe weakness. On 05/03/01, the patient called the clinic complaining of fever, severe headache, swollen lymph node in the right axilla, malaise and fatigue. He was instructed to come in to the clinic but declined. On 05/06/01, the patient had progressively become worse and was unable to get out of bed. He eventually called EMS for transport to the ER. In the ER he was found to be hypotensive with a systolic blood pressure of 70, fever 38.7C, diffuse myalgia. Negative for abdominal pain, neck stiffness, headache and photophobia. No focal abnormalities found on the exam. Lab results revealed: Acetaminophen levels 10.9 at 09:38 AM and < 10 by 15:35 PM excluded Tylenol as likely etiology of hepatic necrosis (normal range 10-25 therapeutic). WBC 18.5 with 29 bands; Lymphs 2.6 (Low); Monos 17.5 (High); Platelets 141k (low), UA 28 RBC's, proteinuria with bilirubin and ketones no bacteria or WBC's. BUN/ Creatinine 49 / 7.4; initial LFT's AP 59, AST (SGOT) 436 enzymes peaked; SGOT 436, SGPT 362, bilirubin 1.4, alb 273; ESR 4, amylase normal, CPK22. The patient was started on IV cefuroxime for empiric treatment. During the course of hospitalization form 05/06/01 - 05/25/01, the patient had fulminant illness characterized primarily by acute hepatic necrosis and acute renal failure (requiring dialysis), respiratory failure, severe encephalopathy followed by ARDS. The initial diagnosis included acetaminophen toxicity vs serum sickness-like reaction to vaccine. F/U states on 5/7/01 at 09:00, the pt was found apneic despite previous clear CXR and seen alert and responsive at 08:00. CPR and intubation successfully resuscitated the pt. He was moved to ICU and placed on pressor therapy. All findings consistent with disseminated intravascular coagulation (DIC); the symptoms included thrombocytopenia, anemia, hematuria and proteinuria. The pt received erythropoietin to get HgB over 10. He was seen by an Infectious Disease consultant who evaluated the pt in the ICU for the following impressions: acute renal failure, liver enzyme elevation, s/p respiratory arrest and hypotension, r/o sepsis (SIRS), r/o vaccine reaction given 5 days prior, r/o allergic vasculitis, r/o serum sickness, r/o contaminated vaccine, r/o leptospirosis, r/o post streptococcal disease, r/o antigen-antibiotic complex, r/o Goodpasture's syndrome, probable aspiration syndrome noted at the time of intubation. He recommended: obtaining CXR and cover with broad spectrum antibiotics empirically including single dose vancomycin plus ceftizoxime and clindamycin, send serologies to r/o impressions, review vaccine side effects to see if there are similar syndromes listed. The pt was transferred to a rehab facility from 5/25/01-5/30/01 to recover ambulatory capacity. On 5/30/01 had an outpt visit recovering liver and renal function. On 6/7/01, the pt returned for prolonged convalescence, expected back in the US in 1/02 to resume studies. It was also reported that this case was originally sent directly to VAERS by a clinic nurse. From F/U correspondence received on 10/22/01, the correct product administered was IPOL, not Poliovax as Poliovax is not distributed in the US. Follow up e-mail correspondence was received on 5/17/02, however there is no new significant information to be reported.			Y	Y	Y	19	Y		U	04/27/2001	04/29/2001	2	Lab results revealed: Acetaminophen levels 10.9 at 09:38 AM and < 10 by 15:35 PM excluded Tylenol as likely etiology of hepatic necrosis (normal range 10-25 therapeutic). WBC 18.5 with 29 bands; Lymphs 2.6 (Low); Monos 17.5 (High); Platelets 141k (low), UA 28 RBC's, proteinuria with bilirubin and ketones no bacteria or WBC's. BUN/ Creatinine 49 / 7.4; initial LFT's AP 59, AST (SGOT) 436 enzymes peaked; SGOT 436, SGPT 362, bilirubin 1.4, alb 273; ESR 4, amylase normal, CPK22. Lab results: PT 16.7; PTT 73.4 (high); TT 15.7 (high); fibrinogen 178.8 (low); PLT 114k (low); D-dimer 5.57 (high). Work-up included anti GBM ab negative, ASO neg < 100, C3 C4 Ch50 low on 5/8 (c/w DIC), ceruloplasmin low, Hepatitis a, b,c negative. IgM and IgG, cytoplasmic and perinuclear antibody negative r/o Wegner, leptospirosis Antibody negative, admission urine culture negative, stool culture negative, sputum trach aspirate culture from 5/7 showed 2 + staph aureus (MRSA), growth only after five days. Platelets nadired on 05/11, then recovered. Creatinine peaks near 9 (ultimately controlled by dialysis), T Bilirubin peaks at 8.3 (5.7 direct bilirubin) on 5/11, Platelets nadir at 74k, CPK peaked at 789 (nl 4-161). 5/19/01 results: HCT nadirs near 25 on 05/19/01. Creatine 2.1, Hgb 10. Follow-up out patient visit on 06/06/01 - Creatinine 1.2, HCT 36, platelets returned to normal, GOT 46, GPT 70, bilirubin 1.1.	UNK	UNK			Past medical history positive for allergies to cats and pollen questionable history of Hepatitis A and possible other viral Hepatitis at earlier age (not born out by serology).		U2001010460	1						2	Headache; Hyperhidrosis; Lymphadenopathy; Malaise; Pyrexia; Acute respiratory distress syndrome; Alanine aminotransferase increased; Anaemia; Apnoea; Aspartate aminotransferase increased; Blood bilirubin increased; Blood creatinine increased; Blood fibrinogen decreased; Blood urea increased; Disseminated intravascular coagulation; Encephalopathy; Fatigue; Gastrointestinal disorder; Haematuria; Hepatic enzyme abnormal; Hepatic necrosis; Hypotension; Leukocytoclastic vasculitis; Lymphadenopathy; Malaise; Myalgia; Proteinuria; Prothrombin time prolonged; Pyrexia; Red blood cell sedimentation rate decreased; Renal failure; Respiratory failure; Sepsis; Serum sickness; Thrombocytopenia; White blood cell count increased	FLU3~AVENTIS PASTEUR~UO446AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~CONNAUGHT LTD.~T05632~UNK~IM~RA~POLIO VIRUS, INACT. (POLIOVAX)~1|YF~CONNAUGHT LABORATORIES~UA440AA~1~SC~RA~YELLOW FEVER (YF-VAX)~1|FLU3~AVENTIS PASTEUR~U0446AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|IPV~SANOFI PASTEUR~T05632~UNK~IM~RA~POLIO VIRUS, INACT. (IPOL)~2|YF~CONNAUGHT LABORATORIES~UA440AA~UNK~IM~LA~YELLOW FEVER (YF-VAX)~2	USA	Life Threatening,Hospitalisation	Influenza
0176301	10/15/2001	CA	41.0	41		F	10/09/2001	Pt's left deltoid became extremely swollen to the size of an adult fist. It was erythematous and very tender. It responded to ice.									Y	10/03/2001	10/03/2001	0	NONE	OTH	PUB		NONE	Asthmatic			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~EVANS VACCINES~E02791HA~1~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0176302	10/15/2001	TX	27.0	27		F	10/05/2001	Pt developed hives and wheezing. Treated with Benadryl and epinephrine and called EMS for transport to ER. A follow up report received 10/22/2001 adds: Reporter reports almost immediate onset of hives, wheezing after series of injections. Have been giving same shots except new lot of Flu vaccine. Pt denied egg sensitivity. Pt had no record of previous injections in previous 4 weeks. Treated and released from base ER.				Y					Y	10/05/2001	10/05/2001	0		MIL	MIL	NONE	NONE	Allergy to red dye, lobster and oranges.			1						1	Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U0674AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0523L~1~IM~RA~HEP A (VAQTA)~1|IPV~CONNAUGHT LTD.~T1153~UNK~IM~RA~POLIO VIRUS, INACT. (POLIOVAX)~1|MEN~CONNAUGHT LABORATORIES~UB080AA~1~SC~LA~MENINGOCOCCAL (MENOMUNE)~1	USA	Emergency room visit	Influenza
0176303	10/15/2001	TX	19.0	19		F	10/05/2001	Pt developed hives and wheezing and required Benadryl and epinephrine. EMS was called for transport to ER. A follow up report received 10/22/2001 adds: Reporter reports almost immediate onset of hives, wheezing after series of injections. Have been giving same shots except new lot of Flu vaccine. Pt denied egg sensitivity. Pt received IPPD at same time as other injections. Pt had no record of previous injections in previous 4 weeks. Treated and released from base ER.				Y					Y	10/05/2001	10/05/2001	0		MIL	MIL	PPD/Aventis/C063AA/LFA	NONE	NONE			1						1	Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U0674AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0523L~1~IM~RA~HEP A (VAQTA)~1|IPV~CONNAUGHT LTD.~T1153~UNK~IM~RA~POLIO VIRUS, INACT. (POLIOVAX)~1|MEN~CONNAUGHT LABORATORIES~UB080AA~1~SC~LA~MENINGOCOCCAL (MENOMUNE)~1	USA	Emergency room visit	Influenza
0176318	10/15/2001	OH	4.0	4		M	10/11/2001	On 10/05/2001, Pt received MMR #2. On 10/06/2001 pt went to OHER. Left arm swollen, red and warm from shoulder to elbow. Child put on antibiotic, ER doctor ask pt mom to call us. Mom was called 10/10/2001. better. Arm decreased in size.				Y					Y	10/05/2001	10/06/2001	1		PUB	PVT	NONE		Hi Sag & mom			1						1	Feeling hot; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U0311EA1101~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1389K9OZ~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0176337	10/16/2001	NJ	25.0	25		F	10/12/2001	Pt describes that she felt symptoms after vaccination. She felt light-headed, shaky, racy heart. Today she awoke this morning feeling numbness in the left leg. Advised her to consult her PMP. Conformation that 25 year old female had reported recovery by 10/12/01. Best information available indicates that pt has had no previous doses of flu vaccine and that she has no history of adverse events related to vaccines.									Y	10/11/2001	10/11/2001	0		OTH	PVT	BC pills	NONE	Allergies to PCN			1						1	Dizziness; Heart rate increased; Hypoaesthesia; Nervousness	FLU3~SANOFI PASTEUR~U0669AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176338	10/16/2001	KS	58.0	59		F	10/13/2001	The day after vaccine was given, the pt had a fever, weakness, joint aches (states she could barely move) and felt funny. She did miss 2 1/2 days from work but did not see a doctor and did not call a doctor's office. A follow up report received 11/1/2001 adds: Reporter states that pt did have labs drawn but didn't see her physician. She has subsequently recovered. She had no other vaccine at this visit and no other in the previous 4 weeks. She did report achy 2 years ago with flu shot then but no severe effects.									Y	10/02/2001	10/03/2001	1	CPK-247; WBC-11.2; Sed Rate-42 and all other values were WNL.	PUB	OTH	NONE	NONE	Allergies to MS, PCN.	Achey~Vaccine not specified (no brand name)~~56.00~In Patient		1						1	Arthralgia; Asthenia; Blood creatine phosphokinase increased; Feeling abnormal; Pyrexia	FLU3~SANOFI PASTEUR~U0675AB~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176339	10/16/2001	SC	55.0	55		M	10/08/2001	On 10/5/01 at 19:30, the pt hand chills, fever, flushing and shaky and at 22:30 had nausea. On 10/6/01 at 07:00, the pt had chills, fever and loss of appetite. Treated with aspirin and increased fluids. On 10/7/01 at 07:00, the pt had aching joints and weakness. Treated with aspirin and increased fluids. On 10/8/01 at 07:00, the pt had weakness and felt wrung out. On 10/9/01 at 03:00, the pt had weakness and no energy. A follow up report received 10/19/2001 adds: Nurse confirmed pt's hx of illness. Confirmed that he also has hypertension. Reporter shared that there had been a great amount of cold and flu/cough etc in area at the same time of this man's problems.									Y	10/05/2001	10/05/2001	0		PUB	PUB	Diazide; Klonopin; allopurinol; Percocet	NONE	Allergy to IVP dyes; Intestinal Bypass; Kidney stones	Fever~Smallpox (Dryvax)~1~5.00~In Patient		1						1	Anorexia; Arthralgia; Asthenia; Flushing; Nausea; Pain; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U0600AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176340	10/16/2001	MD	63.0	63		F	10/12/2001	Pt developed a localized left deltoid edema and macula erythema. A follow up report received 10/26/2001 adds: Pt received Pneumovax vaccine to left arm and Fluvirin vaccine to right arm on 9/26/01. Reaction occurred approx 3 hours after vaccination-with swelling and redness of left arm. Pt was seen in MD's office on 9/27/01. No treatment was required. Pt fully recovered.									Y	09/26/2001	09/26/2001	0	NONE	PVT	PVT	Premarin; Synthroid; Claritin-D; desipramine	NONE	Hypercholesterolemia; Hypothyroid			1						1	Injection site erythema; Injection site swelling	FLU3~EVANS VACCINES~E03481HA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1071K~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0176341	10/16/2001	CA	40.0	40		M	10/12/2001	Pt developed a temperature of 103F, swelling and redness of arm and painful to move. Treated with aspirin, Tylenol and ibuprofen. Was test for Staph and was negative at time of vaccine.									Y	10/09/2001	10/09/2001	0	NONE	PVT	PVT	NONE	NONE	Allergy to poison oak	Fever~Typhoid Vi Polysaccharide (no brand name)~~12.00~In Patient		1						1	Hypokinesia; Injection site erythema; Injection site pain; Injection site swelling; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0346K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0176395	10/17/2001	IL	40.0	40		M	10/11/2001	Pt developed chills and shivering that started at 21:00 and continued all night.									Y	10/10/2001	10/10/2001	0	NONE	OTH	OTH	NONE	NONE	Seasonal hay fever			1						1	Chills	FLU3~SANOFI PASTEUR~U0591AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176396	10/17/2001	IL	43.0	43		M	10/11/2001	Pt developed chills and uncontrollable shivering. A follow up report received 10/18/2001 adds: Reporter states pt had chills lasting several hours. Did not take temperature; went to bed and recovered with rest. No sequeale to this symptom.									Y	10/10/2001	10/10/2001	0	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Chills	FLU3~SANOFI PASTEUR~U0591AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176397	10/17/2001	FL	93.0	93		M	10/10/2001	Pt developed diffuse rash and itching X 4 days. Treated with Benadryl and Atarax. A follow up report received 10/19/2001 adds: Physician states family reported AE but not able to recall what type distress pt had; Nurse Practitioner went ahead with immunization. Symptoms did subside with 4 days of treatment with Benadryl and Atarax. He's otherwise doing well and his mind is clear.									Y	09/20/2001	10/26/2001	36	NONE	OTH	PVT	Captrapril, Lasix, Flomax		Atrial Flutter/CHF; Osteoarthritis	Rash~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U0599BA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176398	10/17/2001	FL	42.0	42		F	10/11/2001	Sore, lump, red, and itching at the site. Symptoms started 24 hours after injection. Also lumps inner aspect of the upper arm. No treatment.  A follow up report received 10/18/2001 adds: Pt reports she has almost completely recovered from site reaction. Had no other vaccine at that date; has had no other vaccines in past month. Has had flu vaccines for the last 3 years and has never had an AE previously.									U	10/04/2001	10/05/2001	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site mass; Injection site pain; Pruritus	FLU3~SANOFI PASTEUR~UO600AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176399	10/17/2001	MD	87.0	87		M	10/11/2001	Acute generalized urticaria. The patient was placed on Benadryl for urticaria which progressed as any other problems. He received no other vaccines on that day, he is on no regular meds has had 3 other recorded flu shots, but has never before had an adverse event to any vaccine.				Y					Y	10/10/2001	10/10/2001	0		PVT	PVT		NONE	NONE			1						1	Urticaria	FLU3~EVANS VACCINES~EO2761HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0176400	10/17/2001	LA	6.0	6		M	10/11/2001	This patient received a flu shot on 10/10/2001 and the following morning broke out in whelps on his back, ear, neck and chest. Saw the doctor 10/11/01. The doctor order Atarax and Patanol for eyes itching and redness. The child also complained of headache and eyes were swollen. Follow up 10/19/2001: RN confirmed that child was improving when seen in the office morning of October 11; he was given the meds to decrease the time to fully recover from the urticaria and rash.  No other vaccines at this visit, no vaccines in previous 4 weeks, no history of adverse events for child.  Reporter confirmed that child was improving when seen in the office morning of Oct 11: he was given the meds to decrease the time to fully recover from the irticaria and rash. No other vaccines at this visit, no vaccines in previous 4 weeks, no Hx of AE for child.				Y					Y	10/10/2001	10/11/2001	1	NONE	PVT	PVT	Adderall	NONE	Asthma, ADHD			1						1	Eye disorder; Eye swelling; Headache; Ocular hyperaemia; Pruritus; Rash; Urticaria	FLU3~EVANS VACCINES~EO2751HA~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0176401	10/17/2001	FL	65.0	65		F		No data entered A follow up report received 10/19/2001 adds: Became sick, weak, dizzy, lightheaded and feverish (temp 100) evening of 10/4/01. Ached all over. Took Ibuprofen before going to bed-felt much better in AM. Arm black and blue for 2 weeks.									Y	10/02/2001	10/04/2001	2		UNK	UNK	Prilosec, Ibuprofen	NONE	Rheumatoid arthritis, Gastric reflux			1						1	Asthenia; Dizziness; Pain; Pyrexia	FLU3~SANOFI PASTEUR~UO547AA~6~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176402	10/17/2001	VA	4.0	4		M	10/11/2001	Hives at the vaccine site and even all over his body within 15 minutes. Benadryl with resolution in 10 minutes.  Follow up 10/19/2001: MA who gave vaccination confirmed that child received flu shot only.  No other vaccines given in the previous 4 weeks; mother did elude to a possible egg sensitivity.  Report correct; child did clear within 10 min of receiving benadryl. MA who gave vaccination confirmed that child received flu shot only. No other vaccines given in the previous 4 weeks: mother did elude to a possible egg sensitivity. Report correct: child did clear within 10 mins of receiving benadryl.									Y	10/10/2001	10/10/2001	0		PVT	PVT						1						1	Urticaria	FLU3~SANOFI PASTEUR~UO5993A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176447	10/18/2001	IL	57.0	56		F	10/11/2001	On 10/8/01 at 18:15, pt went to ER with itching, facial flushing, throat tightness and stridor. At 18:20, she was given epinephrine 1:1000 0.2cc SC-IV and started Benadryl 25mg IV, Solu-Medrol 125mg IV and Zantac 50mg IVPB. At 18:35, Benadryl 25mg IV was repeated. At 20:20, she was discharged home. Her temperature was 97.3F (oral); HR 120; Respirations 22 and BP 168/96 on arrival.			Y	Y					Y	10/08/2001	10/08/2001	0		PUB	PVT	Drovan; Verapamil; Allegra; Singulair; Premarin	NONE	Asthma; HTN			1						1	Blood pressure increased; Flushing; Heart rate increased; Hypothermia; Pruritus; Respiratory rate increased; Stridor; Throat tightness; Erythema; Laryngospasm; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0591CA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening	Influenza
0176458	10/18/2001	IL	1.5	1	.5	M	10/16/2001	Fussiness x 2 nights after vaccine given. Inappropriate dose given, 0.5 ml instead of 0.25 ml									Y	10/15/2001			NONE	PVT	PVT	Zithromax	Resolving otitis				1						1	Irritability	FLU3~SANOFI PASTEUR~U0575AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176459	10/18/2001	CA	46.0	46		F	10/03/2001	Within 4 hours, swelling, redness and discomfort noted left upper extremity. Also noted entire body ached plus headache. Bedridden on second day. Second day redness less, swelling into left breast. Third day swelling less, discomfort at left axilla, body ache only shoulders, neck and headache.									U	10/01/2001	10/01/2001	0		PUB	PUB	Tamoxfin 20mg po daily	NONE	Breast CA, bone marrow transplant 03-29-2000		CA010108	1						1	Discomfort; Headache; Injection site erythema; Injection site oedema; Pain	FLU3~AVENTIS PASTEUR~U0592AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~5183A4~1~IM~LA~HEP B (ENGERIX-B)~1|PPV~PFIZER\WYETH~476951~1~SC~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0176491	10/19/2001	NJ	24.0	24		F	10/17/2001	Patient began feeling dizzy approximately 1 minute after receiving 0.5cc influenza vaccine. She then felt nausea and light headed. Placed patient in more reclining position with legs up. Gave water, cool cloth and blanket. Patient remained alert and conscious. Fully recovered within 20 minutes. FU phone call 10/17/2001, patient reports no problems.									Y	10/16/2001	10/16/2001	0	NONE	OTH	PVT		NONE	Denied allergy to eggs and thimersol.			1						1	Dizziness; Nausea	FLU3~EVANS VACCINES~E05231KA~1~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0176492	10/19/2001	LA	11.0	11		F	10/12/2001	Pt had pain in right hip. Follow up 10/25/2001: Reporter states child had onset of cold-like symptoms and then pain in the hip.  Physician has xrayed hip/negative.  Using tylenol, heat to area.  Flu shot given in the right deltoid, no other vaccine at time, not ill at time of vaccine, no history of adverse events in past.				Y					U	10/08/2001	10/09/2001	1	Sed rate 27 (normal 0-20) CBC wnl	PVT	PVT	Insulin		Diabetes			1						1	Pain	FLU3~SANOFI PASTEUR~U0574AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0176531	10/22/2001	NH	60.0	60		F	10/16/2001	The patient experienced cramps and diarrhea within the first 24 hours after the vaccination, lasting approximately 48 hours.									Y	10/02/2001	10/03/2001	1	NONE	OTH	OTH	Lotension, Inderol, Synthroid and Liptor.	NONE	Hypertension, unactive thyroid.			1						1	Abdominal pain; Diarrhoea	FLU3~SANOFI PASTEUR~U0599BA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176532	10/22/2001	MA	7.0	6		F	10/16/2001	Child developed local reaction to flu vaccine beginning the following morning after injection. Reaction site increased in size to baseball size on deltoid. No symptoms of abscess. Child brought to office on third day after injection.  Follow up 10/25/2001: Child had no other vaccines at this visit.  No other vaccines in prevous 4 weeks, on no medication, no history of previous adverse events.				Y					Y	10/12/2001	10/13/2001	1		PVT	PUB		NONE	Reactive Airway Disease			1						1	Injection site mass	FLU3~SANOFI PASTEUR~UO571AD~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0176533	10/22/2001	MA	73.0	73		F	10/18/2001	On 10/16/2001 vaccine given, originally no reaction noted. On 10/17/2001 about 1/2 inch localized pink area with edema and slightly warm to touch. Warm compress applied.									Y	10/16/2001	10/17/2001	1	NONE	UNK	UNK		Had reaction to neurotin.	Back surgery			1						1	Erythema; Feeling hot; Oedema	FLU3~SANOFI PASTEUR~U0571AD~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176534	10/22/2001	MA	87.0	87		M	10/18/2001	On 10/16/2001 vaccine given, originally no reaction noted. On 10/17/2001 about 1/2 inch localized pink area with edema and slightly warm to touch. Warm compress applied.									Y	10/16/2001	10/17/2001	1	NONE	OTH	UNK	Alverone, BP meds, Coumadine	NONE	Had a cold about 2 weeks prior to vaccine.			1						1	Injection site hypersensitivity; Oedema; Vasodilation procedure	FLU3~SANOFI PASTEUR~UO571AD~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176535	10/22/2001	MA	55.0	55		F	10/18/2001	On 10/16/2001, vaccine given, no reaction. On 10/17/2001 had a one and one-half inch red, slightly swollen and slightly warm reaction. Instructed to take Benadryl and put warm compresses. Did not do. On 10/18/2001 red area increased to about 2.5 inches of redness and slightly warm to touch. Instructed again to take Benadryl.									Y	10/16/2001	10/17/2001	1	NONE	OTH	UNK		NONE	UNK			1						1	Injection site reaction; Oedema; Vasodilation procedure	FLU3~SANOFI PASTEUR~UO571AD~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176536	10/22/2001	MA	57.0	57		F	10/18/2001	Originally had no reaction given on 10/16/01. On 10/17/01, area became red, swollen, warmth n4 in diameter. On 10/18/01 decreased redness and warmth putting Benadryl cream on left arm.									Y	10/16/2001	10/17/2001	1	NONE	OTH	UNK	NONE	NONE	UNK			1						1	Injection site oedema	FLU3~SANOFI PASTEUR~U0571AD~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176537	10/22/2001	MA	57.0	57		F	10/18/2001	Given vaccine left deltoid, c/o itchiness, then became red, approximately 3 area of edema and warm to touch on 10/17/01. Reaction increased in size, approximately 6 red area, swollen and warm. Put cool - warm compresses and took Benadryl. On 10/18/01 decreased redness and warmth.				Y					Y	10/16/2001	10/16/2001	0	NONE	OTH	OTH		NONE	Latex sensitivity			1						1	Injection site hypersensitivity; Injection site oedema; Injection site swelling; Injection site warmth; Pruritus; Vasodilation procedure	FLU3~SANOFI PASTEUR~U0571AD~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0176538	10/22/2001	NH	47.0	47		F	10/16/2001	Cramps. Diarrhea, within 24 hours and lasted about 2 to 5 days.									Y	10/01/2001	10/02/2001	1	NONE	OTH	OTH	Lotenseon prem; pro	NONE	hypertension			1						1	Abdominal pain; Diarrhoea	FLU3~SANOFI PASTEUR~U0599BA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176539	10/22/2001	NM	23.0	23		F	10/10/2001	Influenza administered right arm; 2 inch radius around shot, red blotched and hot with touch. Arm all the way to hand tingles (next day at 1600).									Y	10/09/2001	10/09/2001	0		MIL	MIL						1						1	Hypersensitivity; Paraesthesia	FLU3~SANOFI PASTEUR~U0674AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176540	10/22/2001	PA	66.0	66		F	10/13/2001	Pt developed nausea vomiting SOB within 24 hours of receiving influenza shot				Y					U	10/12/2001	10/13/2001	1	CBC lytes gln Buw  Normal	OTH	OTH	Synthroid, Librax	NONE	hypothyroidism, anxiety			1						1	Dyspnoea; Nausea; Vomiting	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0176541	10/22/2001	MO	54.0	54		F	10/12/2001	Pt got myalgia, fever 24 ph after vaccine. By noct am, edema, erythema and warmth at injection site.   by 4-5 days.									Y	10/08/2001	10/09/2001	1	NONE	PVT	UNK	Zanax wabab, Estrogen, Darvon Ma Ml	NONE				1						1	Feeling hot; Injection site erythema; Injection site oedema; Myalgia	FLU3~SANOFI PASTEUR~V0575A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176542	10/22/2001	NJ	27.0	27		F	09/14/2001	The pt described sensation of B/L finger swelling and shaking. No erythema, edema or bruising noted at injection site. Symptoms abated.									Y	10/13/2001	10/13/2001	0		MIL	MIL		NONE	NONE			1						1	Oedema peripheral	FLU3~SANOFI PASTEUR~U0674AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~U0377AA~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1|TYP~CONNAUGHT LABORATORIES~R1121~UNK~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|YF~CONNAUGHT LABORATORIES~UA439AA~UNK~SC~LA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0176597	10/23/2001	NE	30.0	30		F	10/18/2001	Pt developed pain, redness and heat that measured 4 1/2 by 3 1/2, at the injection site. Pt was given Diprolene cream to help with itching.									Y	10/15/2001	10/15/2001	0		PVT	PVT						1						1	Injection site erythema; Injection site pain; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U0575AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176598	10/23/2001	PA	48.0	48		M		Employee called on 10/15/01 to report that at 23:00 that evening, post vax, he developed a headache, lower back and knee joint pain. The following day, pot vax, on 10/10/01, he had a low-grade fever of 100F, muscle aches, felt very fatigued and experienced diarrhea. On 10/11/01, muscle aches improved, no diarrhea but had malaise. He took 1000mg Tylenol. On 10/12/01, myalgia was gone, had no diarrhea, no fever but felt tired. On 10/13/01, he felt fine.									Y	10/09/2001	10/09/2001	0	NONE	PUB	OTH	Niospan; ASA 1 po daily	NONE	Allergy to dust; (currently on Niospan and ASA for increased triglycerides)	Similar symptoms last year~Influenza (Seasonal) (Fluzone)~~47.00~In Patient		1						1	Arthralgia; Back pain; Diarrhoea; Fatigue; Headache; Malaise; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U0675BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176599	10/23/2001	PA	42.0	42		F	10/15/2001	Reported to Employee Health office at 12:45, indicating that she did not feel well since receiving the flu shot this morning. Complained of onset of headache and pain in the right side of her neck radiating down her back. She rated pain as a 5 on pain scale of 0-10. BP-120/72; P-70; R-16; temperature 98.2F. Injection given in left deltoid. There was no redness, swelling or warmth although she reports it does feel sore. Physician notified and she was given Motrin 400mg po at 12:55. On 10/18/01, no further complaints, it was resolved.				Y					Y	10/15/2001	10/15/2001	0	NONE	PUB	PVT		NONE				1						1	Back pain; Blood pressure increased; Headache; Hypoventilation; Injection site pain; Neck pain	FLU3~SANOFI PASTEUR~U0675BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0176600	10/23/2001	IN	75.0	75		F	10/15/2001	Swollen upper lip, edema and redness at injection site. 6X10 cus. A follow up report received 11/01/2001 adds: Reporter gave additional time line info; pt seen at local ER on 10/14/01 where she was given Decadron and Depomedrol; she was checked in the office on the 15th with some improvement. Office personnel saw her in passing today and she looks well.				Y						10/12/2001	10/13/2001	1		PVT	PVT	Premarin, calcium, Lipitor, Prilosec	NONE	Tetracycline allergy - stomach cramps with notencum.			1						1	Injection site oedema; Swelling face	FLU3~SANOFI PASTEUR~U09533AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0176601	10/23/2001	MA	70.0	70		F	10/18/2001	Local redness and edema at site of injection. A follow up report received 10/25/2001 adds: Reporter states Pt was treated with Augmentin and problem cleared within a few days.									Y	10/16/2001	10/17/2001	1		PVT	PVT	Lipitor, Tagamet, Atenolol	NONE	KNDA			1						1	Injection site oedema	FLU3~SANOFI PASTEUR~U0593AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176602	10/23/2001	MS	75.0	75		M	10/16/2001	Left arm with raised area at ? site injection below bruised in about a 12 inch area running down arm also yellowish area.				Y					U	10/10/2001	10/12/2001	2		PUB	PUB	Baby ASA and Altrace	NONE	NKDA-HTN Bypass surgery			1						1	Contusion; Injection site swelling	FLU3~SANOFI PASTEUR~U0601AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0176603	10/23/2001	IL	63.0	63		F	10/16/2001	Symptoms started 13:30 PM, unable to raise right arm. Swollen right arm. Aching on back on right arm. When arrived home after work applied ice. Then went to heat during night. Unable to sleep, taking Advil, rated pain as 9 on scale 1 to 10. Advil doesn't relieve pain. Advised to check with her doctor. 10/17/01, spoke with pt, she did not go to doctor. Pain decreased with ice, heat, Aleve, back at work. A follow up report received 10/25/2001 adds: Pt was very clear she had much improved overnight when reporter had called day after injection given.									Y	10/15/2001	10/15/2001	0		PUB	PVT		NONE				1						1	Injection site oedema; Insomnia; Pain	FLU3~SANOFI PASTEUR~U0574AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1448K~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0176604	10/23/2001	PA	46.0	46		F	10/15/2001	Reported onset of headache about 10-15 minutes after injection given. Also complained of arm aching and pain down right arm. Rated pain as a 5 on pain scale of 0 to 10. Took 2 Motrin around 9 am which has helped the headache and sore arm. Right deltoid area with swelling, redness and warmth. Physician follow up call no headache, arm just sore, but better.									Y	10/15/2001	10/15/2001	0	BP 122/68-80-16 temperature 98.2	PUB	PVT	Claritin, Pulmacort and Albuterol.	NONE	Environmental Allergies			1						1	Feeling hot; Headache; Injection site erythema; Injection site oedema; Pain	FLU3~SANOFI PASTEUR~U0675BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176651	10/24/2001	MN	74.0	73		M	10/18/2001	On 10/12 at 9 pm, presented to IC nurse who gave immunization. Rash over entire body, sent to Clinic, was put on Benadryl. States woke up with rash in morning, also had pied for sipper the night before? of reaction from olsu. Rash gone in a few days.				Y					Y	10/11/2001	10/12/2001	1		PUB	PVT	BP Medicine, cholesterol medicine, insulin and arthritis medicine.	NONE	Diabetes, high blood pressure and high cholesterol.			1						1	Rash	FLU3~SANOFI PASTEUR~U0672AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0176652	10/24/2001	FL	37.0	33		M	10/17/2001	Day after receiving vaccine, lip was swollen- 2 days later had hives on legs, 4 days later hives on arm, upper back with itching.									N	10/05/2001	10/06/2001	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Hypersensitivity; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176653	10/24/2001	MA	70.0	70		F	10/19/2001	Received call on 10/18/2001 regarding a reaction at site. The injection was given 10/16/2001, client complained of warmth at site, redness and tenderness as well as a bump. Area of redness is about the size of a half dollar. Called 10/19/2001 following heat, swelling is down, redness abating and less tender.									Y	10/16/2001	10/17/2001	1		PUB	PUB	Phenobarbital, Aldactazide and Prevachol.	NONE	High blood pressure, high cholesterol and seizures.	~Pneumo (no brand name)~1~60.00~In Sibling		1						1	Injection site erythema; Injection site mass; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U0571AD~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176654	10/24/2001	NH		55		F	10/17/2001	Onset of diarrhea after injection. (with 24 hr) Still having same discomfort so question if really related									Y	10/05/2001	10/06/2001	1	NONE	OTH	OTH	Zoloft, Tapamax for magraines.	NONE	NONE			1						1	Diarrhoea	FLU3~SANOFI PASTEUR~U0599BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176655	10/24/2001	MI		50		F	10/18/2001	Both arms, above elbows red, swollen, joints ache, red streak inside right arm by elbow. Upper arms warm to touch.									Y	10/15/2001	10/16/2001	1		PVT	PVT	Norvase, Claritin, Flovent, Aleese, vitamins, Keflex	Lt otalgia? Dental abscess	Penicillin			1						1	Arthralgia; Injection site oedema; Vasodilation procedure	FLU3~SANOFI PASTEUR~68575AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~424939~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0176656	10/24/2001	CA	50.0	50		F	10/16/2001	After receiving flu vaccine, pt felt deep ache and weakness down left arm. Injection given October 11, 2001 in left deltoid. Pt taking large amounts of Tylenol.										10/12/2001	10/13/2001	1		MIL	UNK	Synthroid, Prozac and Wellbutrin.	NONE	PCN, sulfa, depression and hypothyroid.			1						1	Depression; Hypothyroidism; Myasthenic syndrome; Pain	FLU3~SANOFI PASTEUR~U0592AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176657	10/24/2001	OH	68.0	68		M	10/17/2001	Pneumococcal vaccine RD-SQ 10/15/2001. Complained of Redness at site. High fever 103 degrees. Tx Tylenol, cool compress. Referred to family practice.									Y	10/15/2001	10/17/2001	2		OTH	PVT	NONE	NONE	NONE			1						1	Pyrexia	FLU3~SANOFI PASTEUR~U0595AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1448K~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0176658	10/24/2001	MA	80.0	80		F	10/18/2001	Small bump at injection site right arm at time of injection of flu vaccine (IM).									Y	10/18/2001	10/18/2001	0		OTH	PUB						1						1	Injection site oedema	FLU3~SANOFI PASTEUR~U0599AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176659	10/24/2001	TX	54.0	54		F	10/15/2001	After receiving flu shot, went home and went to sleep. Approximately seven hours later, awoke with rash around waist that progressed to hives all over body and swollen eyelids. No shortness of breath. Missed two days of work. Saw private MD and put on Atarax and Benadryl.				Y					Y	10/12/2001	10/12/2001	0	NONE	PVT	PUB	Benadryl, Septra, Flonase prn and also on Solu-Medtrol dosepak.	Bladder infection	Allergic to Acromycin 30 years ago, hives, SOB.			1						1	Face oedema; Rash; Urticaria	FLU3~SANOFI PASTEUR~U0681AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0176660	10/24/2001	OH	53.0	53		F	10/17/2001	Three quarters to one inch diameter lump at injection site. Raised and hot to touch with erythma. Benedryl 25mg po given. Ice applied to affected area for 15 minutes.									N	10/16/2001	10/16/2001	0		OTH	PVT	Cafeort, Prometium, Premarin and Prinivil.	NONE	Diabetes, new onset (early 2001)			1						1	Diabetes mellitus; Erythema; Injection site oedema; Vasodilatation	FLU3~SANOFI PASTEUR~U0681AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176661	10/24/2001	VA	34.0	34		F		Low grade fever, very achy. Left arm at injection site red and swollen approximately 2 inches by 2 inches.										11/20/1997	11/21/1997	1	NONE	UNK	UNK						1						1	Injection site erythema; Injection site oedema; Pain; Pyrexia	FLU3~CONNAUGHT LABORATORIES~7F81749~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176662	10/24/2001					U		Bradycardia, drug induced hypotension, weakness and respiratory depression.									U					UNK	UNK						1						1	Asthenia; Bradycardia; Hypotension; Hypoventilation	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0176721	10/25/2001	MD	49.0	49		F	10/17/2001	Pt developed a fever of 102F-103F, 24 hours, post vax. The fever lasted 6 days (101F-102F). She had extreme body/muscle aches and was dx'd with pneumonia, 5 days, post vax. Followup states coughing and wheezing, treated with Tilade			Y	Y					Y	10/03/2001	10/04/2001	1	CXR on 10/8/01-positive for RLL Pneumonia	OTH	PUB	NONE	NONE	NONE			1						1	Cough; Pain; Pneumonia; Pyrexia; Wheezing	FLU3~SANOFI PASTEUR~U0669AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0176748	10/25/2001	FL	70.0	70		M	10/18/2001	Swelly, redness and warmth right deltoid.									Y	10/10/2001	10/11/2001	1	NONE	PVT	PVT	Prinurl, Adexu, Combiveal, zeutar	NONE	CAD, COPD, Cellepc rlunetu			1						1	Feeling hot; Injection site oedema	FLU3~SANOFI PASTEUR~U068LAA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0995L~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0176749	10/25/2001	KS	54.0	54		F	10/24/2001	Back pain, swollen right arm, face swollen, right side, neck pain, nausea went to ER - Diagnosed with local reaction Taken within Demerol, amonicillin. For spider bite on foot 10 days old (left foot). Went to ER also on 10/20/2001. Taken with phenerean and Demerol.				Y					Y	10/19/2001	10/19/2001	0		PVT	PVT	Asthma curt, xopenex, rhinacort, aqua, lopio, inderol, nexium, HRT, Naprosin, Calcium, Zarter, Knonopin	Nephropathy, spider bite, copd, asthma, gerd, hyperchlov				1						1	Back pain; Face oedema; Nausea; Neck pain; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0176750	10/25/2001	CA	47.0	47		M	09/27/2001	Fever, chills times 3 days, acetaminophen 500 mg every 8 hours.									Y	09/21/2001	09/21/2001	0		PUB	PVT		NONE	NONE			1						1	Pyrexia	FLU3~SANOFI PASTEUR~U0592AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176751	10/25/2001	CA	22.0	22		F	09/27/2001	Fever, chills, nausea, body ache, headache, congestion.									Y	09/12/2001	09/21/2001	9		PUB	PVT		NONE	NONE			1						1	Chills; Nasal congestion; Nausea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U0572AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176752	10/25/2001	CA	38.0	38		F		Hives on Saturday. Asthma, SOB, fever and diarrhea.				Y					Y	09/20/2001	09/21/2001	1		PUB	PVT	Lotension; Norvasc	Lupus	Lupus			1						1	Asthma; Diarrhoea; Dyspnoea; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U0592AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0176753	10/25/2001	CA	36.0	36		F	09/28/2001	Tiredness, sneezing, stuffy nose, cough, sweating, itchy and watery eyes, headache, sensitivity to light, loss of appetite and sore throat for seven days.									Y	09/27/2001	09/28/2001	1		PUB	PVT		NONE	NONE			1						1	Anorexia; Cough; Eye irritation; Fatigue; Headache; Hyperhidrosis; Lacrimation increased; Nasal congestion; Pharyngolaryngeal pain; Photosensitivity reaction; Sneezing	FLU3~SANOFI PASTEUR~U0592AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176754	10/25/2001	OR	45.0	45		F	10/22/2001	Approximately three to four hours after administration, pt was sweating, rapid heart rate, rapid, shot breathing, low blood pressure and feeling weak.				Y					Y	10/19/2001	10/19/2001	0	BP 110/70 HR 115	OTH	PVT	Fastin, Combivent, Wellbutrin SR, and Vioxx.	NONE	Asthma			1						1	Asthenia; Heart rate increased; Hyperhidrosis; Hyperventilation; Hypotension	FLU3~SANOFI PASTEUR~U0598AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0176755	10/25/2001	IA	19.0	19		F	10/14/2001	Warm, red, raised area at injection site, 24cm in diameter, no respiratory distress, note 18.5 hours later.									Y	10/13/2001	10/14/2001	1	NONE	MIL	MIL	Orthotrycyclin	NONE	Penicillin allergy		IA01014	1						1	Feeling hot; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U0674AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176756	10/25/2001	KY	17.0	17		F	10/23/2001	Fine rash around sit ot tight deltoid. Pt reported short loss of breath all day attended school didn't visit school nurse. Called health department at 1500, referred for shortness of breath. Possibly allergic reaction. Treated 10/23/2001 with Decadrom IM and Preventil. Nebulizer treatment. Sent home with Prednisane pack and Proventil Inhaler.				Y					Y	10/22/2001	10/23/2001	1	NONE	PUB	PVT		NONE	Allergic to Motrin, Keflex, Penicillin, Phenrgan and Benedryl.		KY2001079	1						1	Dyspnoea; Rash	DTP~CONNAUGHT LABORATORIES~U0323AA~6~IM~LA~DTP (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U0590AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1422K~2~IM~RA~HEP B (RECOMBIVAX HB)~1	USA	Emergency room visit	Influenza
0176757	10/25/2001	OR	82.0	82		F	11/21/2000	Spontaneous report received on November 16, 2000, from Medical Assistant in a Dermatologist office, regarding adverse event possibly related to administration of Fluvirin. On October 06, 2000, this 83 year old female received a Fluvirin injection. Shortly after receiving the injection, she developed a temperature of 102 degrees, chills and general malaise. These symptoms lasted approximately four days. In mid October, she developed lesions on her hands and in her mouth. She was treated with an unspecified course of Prednisone, with symptom abatement. After completion of the Prednisone therapy, the symptoms reappeared. She was then treated with an injection of Kenalog and topical use of Orobase and Kenalog ointments; lesions remain at the time of this report. The diagnosis of Stevens Johnson Syndrome has been made. The reporter stated that the Dermatologist's office has treated this patient for over ten years. She indicates that the pt is normally very mentally there but that the pt hasn't been herself. She describes pt as being easily confused and forgetful.  Additional information has been requested from the physician. Follow up information from Primary care physician received on October 11, 2001 by Evans Vaccines: The additional adverse events of sore throat and swollen lip were identified. PT has resolution of symptoms by November 20, 2000. Dosages and therapy dates of concomitant medications were clarified.									Y	10/06/2000				PVT	OTH	Cozaar, Norvasc, Temazepam, Cidihiua, Chlordiazepoxide and Levothroxine, potassium		Hypertension, Pharyngitis, Hypothyroidism, G I problems, increased weight loss		MPI2000049221	1						1	Confusional state; Disturbance in attention; Malaise; Pharyngolaryngeal pain; Pyrexia; Skin ulcer; Stevens-Johnson syndrome; Swelling face	FLU3~MEDEVA PHARMA, LTD.~E6732QHA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0176758	10/25/2001	NY	30.0	30		M	10/23/2001	Pt developed sores in mouth and aching in muscles and joints and was also tired.									U	10/19/2001	10/20/2001	1	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Arthralgia; Fatigue; Mouth ulceration; Myalgia	FLU3~EVANS VACCINES~E02081HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0176768	10/26/2001	CA	52.0	52		M	10/25/2001	Fot Flu shot 10/16/2001. On 10/21/2001 had coughing, hot feeling, sweating, flem in throat, light headedness and weakness. Has lasted four days so far. Not real sick, just slightly.				Y					N	10/16/2001	10/21/2001	5		PUB	OTH	Respidal, Flucaplage, etc.	NONE	Diabetes, High Blood Pressure and bad nerves.			1						1	Asthenia; Cough; Dizziness; Feeling hot; Hyperhidrosis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0176769	10/26/2001	OK	46.0	46		F	10/25/2001	Pt had very sore left pectoral muscle, up into left armpit. Had fever at the site of the injection, mild nausea and pulsating pain in left pectoris, onset the day after injection.									Y	10/23/2001	10/24/2001	1	NONE	PVT	PVT	NONE		NONE			1						1	Injection site pain; Injection site warmth; Nausea	FLU3~SANOFI PASTEUR~U0672AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176785	10/29/2001	NY		42		F	10/24/2001	Felt chills and aches next morning. Left work to rest and slept until 3pm. Visited physician. Body aches, stomach aches. Physician advised pt she had stomach virus. Pt reports fever. Went to ER. Had diarrhea. Advised to take Tylenol and liquids.				Y					Y	10/22/2001	10/23/2001	1	NONE	UNK	UNK	Levoxil and Xelexa.		Allergic to Codeine			1						1	Abdominal pain; Diarrhoea; Myalgia; Pain; Pyrexia; Viral infection	FLU3~SANOFI PASTEUR~U00682HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0176786	10/29/2001	NY	37.0	37		F	10/25/2001	The client had injection at 13:00. Called at 15:30 and stated hives on throat, chest and right arm. Client taken by security to health office. Vital signs: temperature 98; P-64; BP-114/70; R-20. Report to MD and administered Benadryl 50mg, IM and called EMS. Pt taken to ER for evaluation. A follow up report received 10/31/2001 adds: Nurse associate of the reporter states she has followed the pt who continued to use Benadryl to control the hives which she has had following the flu shot. This pt has never had a flu shot before. Last report was that she had no worsening of her symptoms; had had hives on her back the morning after she was seen in the ER.				Y					U	10/25/2001	10/25/2001	0		PUB	PUB	NONE	NONE	NONE			1						1	Blood pressure decreased; Urticaria	FLU3~EVANS VACCINES~E102781HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0176788	10/29/2001	UT	79.0	79		F	10/17/2001	Pt reports pain, itching, H.A., warmth in right arm from shoulder to elbow 2 hours following injection of Pneumococcal vaccine. Later noticing swelling, redness. Pt notified her physician on 10/16/2001. He prescribed Benadryl 50 mg TID, cold packs, nurse advised Tylenol.									U	10/16/2001	10/16/2001	0	NONE	PUB	PVT	Beta Pace 120 Mg - 1 daily Synthroid 88 mg. 1 daily	NONE	Allergy to aspirin and inflammatory agents, heart arrhythmia			1						1	Headache; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U0573AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0944K~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0176789	10/29/2001	FL	63.0	63		F	10/17/2001	Pain in arm. A follow up report received 10/31/2001 adds: Reporter states Pt had been to Urgent Care before coming to office. Office notes indicate some warmth at site but no redness or associated symptoms. Pt received no other injection at that date and had no other vaccines in the previous 4 weeks.				Y						10/03/2001	10/03/2001	0		PVT	UNK	Aciphex, Tranzine, Bentylm, Elivil, Claritin, Feoricet, Fosamax, Prevacol, Chloral hydrate, Phenergan	NONE	Bronchoetasis			1						1	Feeling hot; Pain	FLU3~EVANS VACCINES~E02111HA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0176790	10/29/2001	PA	47.0	47		F	10/23/2001	Injection received 10/19/2001, at 1600 pm. On 10/20/2001 at 2:30 pm, noticed swelling and redness at left arm area. Also consist of biceps muscle aching. Described as the size of a 50 cent piece. On 10/20/2001, also developed headache and diarrhea which lasted approximately 1 day and then resolved.									Y	10/19/2001	10/20/2001	1		PUB	UNK		NONE	Propandol; Wellbutrin, Multivitamin			1						1	Diarrhoea; Headache; Myalgia; Oedema	FLU3~SANOFI PASTEUR~U0675BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176791	10/29/2001	MN	46.0	46		F	10/22/2001	Received a flu shot in the am (10/17/01) Within waking night slept. Went home to sleep came back to work at 10 PM that night. Felt itchy all over her body. Noticed redness but no rash or hives. Took Benadryl. It improved. Took Benadryl. It improved. Took 2 more doses of Benadryl over next 24 hours. Redness went away and 24 hours itching stopped.									Y	10/17/2001	10/17/2001	0		PUB	PVT	Insulin Hemalog	Diabetes	Asthma, Hypertension			1						1	Pruritus; Vasodilation procedure	FLU3~SANOFI PASTEUR~U0591AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176792	10/29/2001	TX	73.0	73		F	10/01/2001	Rash on arms and thighs on 9/30/01 at 22:30. Took Atarax 10mg prn itching.									Y	09/27/2001	09/30/2001	3	NONE	PUB	PUB	Insulin; Lipitor; HCTZ; Synthroid; Prempro	NONE	Diabetes		TX01148	1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U0597AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176793	10/29/2001	MA	4.0	4		M	10/25/2001	On 10/24/01 at 11:30, child was brought to ER having a seizure. Temperature was 101F and Advil was given. Seen RN in office for F/U on 10/25/01. Questionable viral illness/reaction to immunization.				Y					Y	10/23/2001	10/24/2001	1	CBS-Chemistry, Hematology and Urine analysis	PVT	PUB	Medicines for post liver transplant	Questionable viral	Liver transplant in 1997			1						1	Convulsion; Pyrexia; Vaccination complication; Viral infection	DTAP~CONNAUGHT LABORATORIES~U0537BA~5~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U0571AD~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~CONNAUGHT LTD.~T0908~4~~RA~POLIO VIRUS, INACT. (POLIOVAX)~1	USA	Emergency room visit	Influenza
0176847	10/30/2001	VA	92.0	92		F	10/19/2001	2 hours, post vax, in the left deltoid, pt developed pruritus of left upper arm. This continued to increase throughout the day and night until we saw her at 10:00 on 10/19/01. At that time, she had diffuse erythema of the left upper arm below the injection site and just above anticubital area, measuring about 10cm.									Y	10/18/2001	10/18/2001	0		PVT	PVT	Fosamax 70mg a week; diltiazem ER 180 q d; Coumadin 2mg					1						1	Injection site erythema; Pruritus	FLU3~EVANS VACCINES~E05211KA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1071K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0176848	10/30/2001	PA	68.0	68		F	10/11/2001	On 10/9/01, right arm was painful, with swelling at the injection site and developed a temperature of 102F. On 10/10/01, swelling extended to right elbow and right shoulder and was still very red and painful. She was dizzy, could not focus and needed assistance walking. She was trembling and had profuse perspiring. On 10/11/01, swelling had slightly subsided and redness had lessened. She saw an MD.				Y					Y	10/09/2001	10/09/2001	0		PUB	OTH	Premarin; Lozol; Vioxx; Prinivil 10mg; Prilosec 20mg	NONE	High BP; Diverticulitis; Stricture of esophagus			1						1	Abasia; Dizziness; Hyperhidrosis; Injection site erythema; Injection site pain; Injection site swelling; Pyrexia; Tremor; Vision blurred	FLU3~SANOFI PASTEUR~U0669AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0690K~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0176849	10/30/2001	MN	71.0	71		F	10/23/2001	Pt reported breaking out in hives all over her body a few hours after receiving the Flu Vax. She said she was also itchy. It went away about 4 days later. She did not report the event until today (10/23/01. A follow up report received 11/1/2001 adds: Confirms history of pt breaking out all over body starting a few hours after she received the flu shot. She had no treatment during the worst 4 days while the hives lasted. She failed to report the effect until the 23rd when she returned to the Dr's office for other care. Record is otherwise correct and complete.									Y	10/15/2001	10/15/2001	0	NONE	PVT	PVT	Nasonex Suspension; Trazadone; Prevachol; Zoloft; Estradiol	Abdominal and chest pain	Allergies to Penicillin V and Potassium			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0572EA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176850	10/30/2001	WI	62.0	62		F	10/19/2001	On 10/17/2001 Pt developed red area about 2 inches diameter on left upper arm where injection was given. On 10/18/2001 advised to mark around red area. use ice on arm and take Benadryl. On 10/19/2001 PC tp pt red area smaller, getting better.									Y	10/16/2001	10/17/2001	1		PVT	PVT	Prevachol, Notriptyline, Paxil, Prilosec, Premrcn and Carafati.		Hazadone, codeine and IV demerol.			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U0590AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176851	10/30/2001	SC	48.0	48		M	10/25/2001	Pneumonia and Flu vaccines given in same arm 1 inch apart. Pt experiencing severe pain at site. Low grade fever, headache, generalized artnralgia and hylgias.				Y					U	10/24/2001	10/24/2001	0	NONE	OTH	PVT	Injectible MVI Biz and folate	NONE				1						1	Headache; Injection site pain; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U0594AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1071K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0176852	10/30/2001	CA	4.0	4		M	10/24/2001	Localized allergic Rxn about about 20 cm eryth/imdurated, warm patch on upper right arm.				Y					Y	10/08/2001	10/09/2001	1		PVT	PVT		NONE	Asthma	Small Knot~DTaP (no brand name)~4~1.00~In Patient		1						1	Injection site erythema; Injection site induration; Injection site warmth	DTAP~CONNAUGHT LABORATORIES~U0532DA~5~IM~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U0595AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~PASTEUR MERIEUX INST.~T0908~4~~RA~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0599L~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0176853	10/30/2001	HI	4.0	4		M	10/17/2001	Four year old with onset of full body urticaual rash about 1 hour after receiving influenza vaccine.				Y						10/16/2001	10/16/2001	0	NONE	OTH	UNK	NONE	NONE	Intermittent Asthma			1						1	Urticaria	FLU3~SANOFI PASTEUR~U0590AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0176854	10/30/2001	HI	3.0	3		F	10/19/2001	Left arm swollen, hard and red. Warm to touch. No fever. Instructed to use ice packs, give Motrin 160mg Q6-8 degrees and Benadryl.				Y					Y	10/16/2001	10/16/2001	0		PVT	PVT	NONE	NONE	NONE		HI0111	1						1	Feeling hot; Oedema peripheral	FLU3~SANOFI PASTEUR~U0573AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0176855	10/30/2001	NC	32.0	32		F	10/24/2001	Reaction 20 minutes post receiving vaccine. Check out hives- breaking out on face, neck, chest, arms, nausea, weakness, lightheadedness.Self medicated with Tylenol and Benadryl. Did not report allergy to eggs. But states eggs made her sick when she was child 10/24/01. A follow up report received 11/1/2001 adds: Pt had long standing food sensitivity to eggs, hives still present 2 days after vaccination given. Pt's reaction has continued to subside, had no other vaccinations at that date or in the month prior. On no meds, no hx of previous AE's with vaccines. Has been advised not to take flu shot again.									Y	10/22/2001	10/22/2001	0	U/A Negative results	PUB	PVT		NONE	NONE			1						1	Dizziness; Nausea; Urticaria	FLU3~SANOFI PASTEUR~U0591DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176856	10/30/2001	PA	71.0	71		M	10/22/2001	Chest tightness, dizziness, shoulder pain. Renalog injection given in return visit.				Y					U	10/22/2001	10/22/2001	0		PVT	PVT		NONE				1						1	Chest discomfort; Dizziness; Shoulder pain	FLU3~SANOFI PASTEUR~U0594AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0176857	10/30/2001	MO	45.0	45		F	10/24/2001	Employee complained of jaw pain, slurred speech and then passed out. Difficulty in moving hands and with communicating. Occurred 15 minutes after flu shot. Pt given Benedryl, steroids, Zofran in ED. Pt observed for several hours then released.				Y					Y	10/01/2001	10/01/2001	0	CT Scan	MIL	OTH	NONE	NONE	NONE			1						1	Hypokinesia; Loss of consciousness; Pain in jaw; Speech disorder	FLU3~SANOFI PASTEUR~U0675AB~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0176858	10/30/2001	TX	18.0	18		F	10/23/2001	Pt received Fluzone at 10:15am. Returned an hour later with swollen right eyelid (upper and lower). No repiratory distress, pain or itching. Awake and alert. Benadry 50mg elixir given and ice pack applied to right eye. No fever.									U	10/11/2001	10/11/2001	0	Vitals 108/56 Pulse 70-16 No fever	OTH	OTH	UNK	Right eye swelling	UNK		TX01159	1						1	Eyelid oedema; Hypotension; Hypoventilation	FLU3~SANOFI PASTEUR~U0675AB~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176859	10/30/2001	KS	59.0	59		F	10/22/2001	Had diarrhea, vomiting, muscle aches more severe and headache. Nauseated, ill feeling. Went to Dr. on 10/17/2001 and he gave me Cedox (antibiotic for sinus infection).				Y						10/09/2001	10/10/2001	1		OTH	PUB	Zoloft, Buspar, Prilosec, Antenolol, hormonesand hydrocodone for back and legs.	Diarrhea	Fragrance, Niacin, Nizeral, Cipro and ploclyco, Morphine and Thirmersol.			1						1	Diarrhoea; Headache; Malaise; Myalgia; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0176860	10/30/2001	LA	63.0	63		F	10/22/2001	Within 2 hours, post vax, my arm was swollen and I had chills and a temperature of 101F and more, which lasted at least 2 days.									Y	10/06/2001	10/06/2001	0		PVT	PVT		NONE	Back and leg pain	Temperature and aches~Influenza (Seasonal) (no brand name)~1~35.00~In Patient		1						1	Injection site swelling; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0176889	10/30/2001	AL	32.0	32		F	10/16/2001	Post vax the patient had swelling at the injection site and severe pain to the elbow. The patient was treated with Solu Medrol and given pain medication. On 10/19/2001 the patient states her arm is better.				Y					Y	10/12/2001	10/12/2001	0	NONE	PUB	PUB	NONE	NONE	Asthma		AL0111	1						1	Injection site pain; Injection site swelling	FLU3~EVANS VACCINES~E00941HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1448K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0176917	10/31/2001	CA	36.0	36		M	10/19/2001	Pt developed red, swollen and hard area at injection site measuring 6.5cm X 9cm, with a red streak 8cm X 4cm at upper arm. Symptoms started (achy and feverish) on 10/18/01 with localized reaction beginning on 10/19/01.				Y					Y	10/17/2001	10/18/2001	1		OTH	PUB	Nasonex nasal spray; Nyquil	NONE	NONE			1						1	Cellulitis; Feeling hot; Injection site erythema; Injection site mass; Injection site swelling; Pain	FLU3~SANOFI PASTEUR~U0601AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~CONNAUGHT LABORATORIES~UA289CA~2~SC~LA~MENINGOCOCCAL (MENOMUNE)~1|PPV~MERCK & CO. INC.~0945K~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TYP~CONNAUGHT LABORATORIES~R1230~2~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0176918	10/31/2001	GA	31.0	31		F	10/30/2001	15 minutes, post vax, pt complained of arms and face tingling. Pt had local reaction of pinkness and slight edema, ice applied. Vitais WNL. No SOB. Pt observed for 2 hours after injection. No further symptoms.									Y	10/30/2001	10/30/2001	0		PVT	OTH			Allergy to bee stings			1						1	Injection site erythema; Injection site swelling; Paraesthesia	FLU3~SANOFI PASTEUR~U0599BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176919	10/31/2001	CA	28.0	27		F	10/19/2001	Within 6 hours erythematous area measuring about 2 cm in diameter was noticed on left arm at injection site. 24 hours later the erythema now measured 7 cm, area was hot to the touch and very swollen, non tender. Condition persisted for another 24 hours before, subsiding.									Y	10/11/2001	10/11/2001	0		MIL	MIL		NONE				1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U0674AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176920	10/31/2001	IA	57.0	57		F	10/17/2001	Stiffness and extreme pain, in neck, back, knees, feet. hands, started within about 2 hours of receiving shot. Pain did not start recede till 10/16/2001. Was the worst pain ever experienced by me. Could not get up without help. Ibuprofen Lortabs.				Y					Y	10/11/2001	10/11/2001	0		PVT	PVT	Cozaar, Glucophage, Premarin, Lamisil, Glucophage, Prozac	slight cold	DM, HTN, Allergy to feathers			1						1	Hypokinesia; Musculoskeletal stiffness	FLU3~EVANS VACCINES~E02111HA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0176921	10/31/2001	MN	88.0	88		F	10/24/2001	10/18/2001 5 PM resident vomiting, temp 101.3 RD had 5 cm raised area. Blotchy areas on thighs and groin. Ran a temp through 10/20/2001, vomiting noted only on 10/18/2001.				Y					Y	10/16/2001			NONE	OTH	PVT	Timoptic of drops ASA 81 mg 64.E.	NONE	dementia post CVA with allergies.			1						1	Injection site swelling; Pyrexia; Rash macular; Vomiting	FLUX~UNKNOWN MANUFACTURER~U0672AA~7+~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0176922	10/31/2001	AK	50.0	50		F	10/12/2001	Flu shot, fever/chills, myalgia, nauseated, headache and flushes.									Y	10/07/2001	10/09/2001	2	NONE	OTH	PVT		GERD			AK200161	1						1	Flushing; Headache; Myalgia; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~U0573AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176923	10/31/2001	AK	44.0	44		M	10/16/2001	Patient's left deltoid, axillae and left chest wall, swollen, red and inflamed. Painful and impedes use of left arm. Symptoms developed 3 days after receiving pneumococcal vaccine in left deltoid. Seen by MD and dx'd with infection and started on antibiotics.				Y					U	10/09/2001	10/12/2001	3		PUB	PUB		NONE			AKZ00162	1						1	Cellulitis; Hypokinesia; Injection site erythema; Injection site inflammation; Injection site pain; Injection site swelling; Swelling	FLU3~SANOFI PASTEUR~U0573AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~474936~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0176924	10/31/2001	AK	39.0	39		F	10/15/2001	Friday 9:30am given flu and pneumonia in right and left aut thighs at pt request. At 5:30pm while in a meeting, experienced sharp pain in left leg (given pneumo in LAT), left the mtg and went home and took pain meds. Slept through the night, slight pain in the morning. At about 2:30pm on Saturday while doing work outside, pt noticed a rash like hives on her upper body and back. Still red on Monday.									Y	10/12/2001	10/12/2001	0		PUB	PUB		NONE	Allergy to cats	Passed out~Vaccine not specified (no brand name)~~0.00~In Patient	AK200163	1						1	Injection site erythema; Injection site pain; Pain; Urticaria	FLU3~SANOFI PASTEUR~U0573AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~474936~1~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0176925	10/31/2001	FL	61.0	61		F	10/25/2001	Shoulder joint pain and restricted range of motion.									Y	10/22/2001	10/22/2001	0		OTH	PVT	Actigall		NONE			1						1	Arthralgia; Hypokinesia	FLU3~EVANS VACCINES~E00931HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0176926	10/31/2001	FL	40.0	40		F	10/26/2001	Light headedness, dizziness, heavy feeling and throbbing in affected arm. Treated with Benadryl 50 mg PO.									Y	10/22/2001	10/22/2001	0		OTH	PVT	Claritin and Oral contraceptive	NONE	Allergy to dust, animal fur and fragrance trees.			1						1	Dizziness; Injection site pain; Sensation of heaviness	FLU3~EVANS VACCINES~E00931HA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0176927	10/31/2001	FL				U	10/25/2001	Light headedness, dizziness followed by syncope lasting approximately 2 minutes treated with Benadryl 50 mg PO.				Y					Y	10/25/2001	10/25/2001	0		OTH	PVT	Tamoxifen and Prozac		S/P Lumpectomy for Breast Cancer treated with CMF last dose 1.5 years ago.			1						1	Dizziness; Syncope	FLU3~EVANS VACCINES~E00931HA~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0176928	10/31/2001	FL	35.0	35		F	10/25/2001	Muscular and shoulder joint pain with restricted range of motion. 11/07/01 Patient diagnosed with bursitis in shoulder of arm vaccinated.				Y					N	10/22/2001	10/22/2001	0		OTH	PVT	Lithium and Seroquel	NONE				1						1	Arthralgia; Bursitis; Hypokinesia; Myalgia	FLU3~EVANS VACCINES~E00931HA~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0176929	10/31/2001	AL	57.0			F	10/18/2001	Rash at injection site and upper left arm. Treatment with Benadryl cream.										10/16/2001	10/16/2001	0		UNK	UNK			Allergies to Steroids and Zestril.  Patient states she took Flu vaccine in 1999 and 200 without any problems.			1						1	Hypersensitivity	FLU3~SANOFI PASTEUR~U0672AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176930	10/31/2001	AL		30		F	10/18/2001	Swollen face and eyes. Treatment with 25mg Benadryl and referred to MD.										10/17/2001	10/18/2001	1		UNK	UNK			UNK allergies. No egg allergy.			1						1	Face oedema	FLU3~SANOFI PASTEUR~U0672AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176931	10/31/2001	IN	68.0	68		F	10/26/2001	Left upper arm from elbow to half way up shoulder, pink warm, and swollen and tender to touch. Family MD thought it was an allergic reaction and pt allergies. Talked with pt 10/25/2001 and she states it is almost better.									Y	10/16/2001	10/17/2001	1		OTH	OTH		NONE	Breast Cancer			1						1	Hypersensitivity; Injection site oedema; Vasodilation procedure; Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U0899BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1448K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0176933	10/31/2001	WV	35.0	35		F	10/30/2001	SOB, itching, coughing, red rash on chest, arm and face. Treated with Akid, Singulair, Prednisone and Allegra.				Y					Y	10/25/2001	10/25/2001	0	NONE	PVT	PVT	Tylenol and Prilosec	NONE	NONE	Emesis~Measles + Mumps + Rubella (MMR I)~1~0.00~In Patient		1						1	Cough; Dyspnoea; Pruritus; Rash	FLU3~SANOFI PASTEUR~U0669AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0176934	10/31/2001	FL	54.0	54		F	10/17/2001	Area of injection became reddened and it change on 10/14/2001. On 10/15/2001 and 10/16/2001 with redness and itching. Improved by 10/17/2001.									Y	10/14/2001	10/14/2001	0		PUB	PVT			Codeine allergy			1						1	Injection site erythema; Pruritus	FLU3~SANOFI PASTEUR~U0675B4~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176935	10/31/2001	NJ	65.0	65		F		Fever 102 degree, malaise, body aches and treatment.									Y	10/24/2001	10/25/2001	1		PVT	UNK						1						1	Malaise; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U0688AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0801L~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0176936	10/31/2001	NJ	36.0	36		F	10/29/2001	5 cm X 3 cm warm erythematous area at vaccination sites. Therapy with reflex 500 mg twice daily.				Y					U	10/26/2001	10/27/2001	1		OTH	UNK						1						1	Injection site erythema	FLU3~EVANS VACCINES~1504821KA~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0176937	10/31/2001	FL	34.0	34		F	10/18/2001	Aching, woke up in middle of night feeling like I was going to pass out. Feeling really flush feeling. Nauseated, Ill feeling passed in about 24 hours.									Y	10/10/2001	10/11/2001	1		OTH	OTH	Flovent, Claritin, Flonase, Cenestin		Asthma, Hypoglycemia Osteoporosis			1						1	Flushing; Malaise; Nausea; Pain	FLU3~EVANS VACCINES~E04821KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0176938	10/31/2001	CT	28.0	28		F	10/30/2001	Right nasal herpes simplex outbreak. Pt previously unexposed/symptom free. Therapy - Famvir.									Y	10/23/2001	10/25/2001	2		PVT	PVT	NONE	NONE	NONE			1						1	Herpes simplex	FLU3~SANOFI PASTEUR~V0668AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176939	10/31/2001	NH	38.0	38		M	10/24/2001	On the afternoon of 10/19/01, the arm that the yellow fever was taken in, there was itching, swelling and a large red circle with about a 4 papular rash. No fever.									Y	10/19/2001	10/19/2001	0	NONE	MIL	MIL	IPPD/PMC/C0835AA/ID	NONE	NONE			1						1	Injection site erythema; Injection site swelling; Pruritus; Rash papular	FLU3~SANOFI PASTEUR~U0674AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|YF~CONNAUGHT LABORATORIES~UB077A~UNK~SC~~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0183773	10/31/2001	UT	50.0	50		F	10/31/2001	Hive on left wrist, immunization give in left arm. 4mg chlorpheriramune give.									Y	10/31/2001	10/31/2001	0	NONE	OTH	PVT	prevacid, Zocor	NONE				1						1	Urticaria	FLU3~SANOFI PASTEUR~U0688AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176995	11/01/2001	NY	80.0	80		M	10/23/2001	3 hours after the pt received the flu and pneumococcal vaccines, the pt had a sudden onset of fever and productive cough. He called me on 10/4/01 and we began Amantadine 50mg and I saw him on 10/5/01 and heard fine, inspiratory crackles, right greater than left, at the base of the lung when present. Chest X-rays showed pulmovascular congestion with cardiomegaly and new bilateral focal infiltrates consistent with pneumonia. Continued on Amantadine and Toquin 400mg po daily was added. He is much improved on 10/15/01 exam.			Y	Y					Y	10/01/2001	10/01/2001	0	CXR-pulmonary vascular congestion and cardiomegaly	PVT	PVT	colchicine; Norvasc; Coumadin; propantheline; Zocor; hydrochlorothinzide	NONE	HTN; Bio-Pressive Aortic rep; increased PSA; gout; tremor; SSS-VVI pacemaker.			1						1	Cardiomegaly; Cough; Pneumonia; Pulmonary congestion; Pyrexia; Stridor	FLU3~EVANS VACCINES~E00941HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1071K~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening	Influenza
0176997	11/01/2001	KS	55.0	55		F	10/23/2001	The pt was seen on 10/03/01 for exam. She was well and was given Pneumovax and flu vaccine, both in the right shoulder. She then developed fever up to 102.4F on 10/5/01, had sweats, chills and a headache. She also had erythema and pain in the left shoulder.									Y	10/03/2001	10/03/2001	0		PVT	PVT	Pepcid; Naprosyn; Pepcid Complete	NONE	NONE			1						1	Erythema; Headache; Hyperhidrosis; Pyrexia; Shoulder pain	FLU3~SANOFI PASTEUR~U0454AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~476952~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0176998	11/01/2001	UT	73.0	43		F	10/19/2001	Pt developed redness, heat and slight swelling on right arm, where pneumococcal vaccine was given. Ice applied X 1.									U	10/16/2001	10/17/2001	1		PUB	PUB	Effexor; Synthroid; Premarin; Morbic; Prevacol; Bu-Scar; Zyprexa; levorex; methotrexate	NONE	Irritable bowel			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U0573AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0690K~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0176999	11/01/2001	KS	64.0	64		M	10/12/2001	About 15-20 minutes, post vax, he got real dizzy and terribly ill. He saw doctor for nausea and vomiting and got a suppository. By 10/1/01, he had to go to ER. He had inner ear infection that had turned into impetigo on ear. On 10/4/01, he was sent to ER and dx'd with Bell's Palsy. He is still suffering from vertigo and depression.				Y					N	09/24/2001	09/24/2001	0		PUB	PUB	gemfibrozil; Voltaren; Prilosec; Hyspar; Ambien; Zyrtec; orphenadrine; Accolate; garlic; Vitamin E					1						1	Bacterial infection; Depression; Dizziness; Facial palsy; Malaise; Nausea; Otitis media; Vertigo; Vomiting	FLU3~SANOFI PASTEUR~U0574AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177000	11/01/2001	WI	66.0	66		M	10/22/2001	Pt reports receiving influenza and pneumococcal vaccines on 10/16/01. Beginning on 10/18/01, a light rash developed over ankles and feet. By 10/19/01, the rash was raised, red on ankles, feet, stomach and chest. No pustules or open lesions. He reports that he has generalized pruritus but no pain. He was encouraged to see his PCP for dx.				Y					N	10/16/2001	10/18/2001	2		PUB	PVT	Paxil 20mg/day; Flonase 1-2 puffs a day		Hayfever and allergy to fresh water fish			1						1	Pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~U0575AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~476952~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0177001	11/01/2001	AS	46.0	46		F	10/13/2001	Pt was dizzy and drunk with bad taste in mouth.									Y	10/02/2001	10/02/2001	0		PUB	PVT		NONE	NONE			1						1	Alcohol poisoning; Dizziness; Dysgeusia	FLU3~SANOFI PASTEUR~U0573AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177002	11/01/2001	NY	52.0	52		F	10/31/2001	Pt had cough and shortness of breath at 10 PM. Runny nose at 4 PM and Temperature at 5 PM. Stuffiness by 8 PM. After 12 hrs all symptoms lessened.									Y	10/23/2001	10/23/2001	0	NONE	OTH	UNK		NONE	Childhood asthma-ongoing to age 15 yrs.			1						1	Cough; Dyspnoea; Nasal congestion; Pyrexia; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0177003	11/01/2001	MI	75.0	75		M	10/18/2001	flu vaccine was given on 10/18/01 at 9:30 AM in the school based Health Center. It was then discovered that the vaccine had expired on 06/01. The client was notified and he denied any symptoms or effects. The Health Dept was notified as well as the manufacturer. The client's family Dr is aware and agreed that the client should be revaccinated, client to return next week.									Y	10/18/2001			NONE	PUB	PUB	Blood pressure medication	NONE	Hypertension			1						1	Unevaluable event	FLU3~PFIZER\WYETH~4008224~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0177004	11/01/2001	TX	44.0	44		F	10/22/2001	Post vax the patient developed a knot in the left deltoid that night. The next day the patient had a hot, large swollen area and some difficulty breathing. The patient was diagnosed with a moderate allergic reaction. The patient experienced wheezing at the time seen and was treated with Medrol dose pack.				Y					Y	10/20/2001	10/20/2001	0	NONE	PVT	PVT	Premarin	NONE				1						1	Dyspnoea; Hypersensitivity; Injection site mass; Injection site swelling; Injection site warmth; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0177005	11/01/2001	MI	37.0	36		F	10/23/2001	45 minutes after the injection the patient had swelling of the upper left arm with pain. The area was 3 in x 4 in. Ice was applied to the site and the patient was referred to community care clinic where she was instructed to continue ice and was gived Motrin and Ultram for pain.				Y					U	10/08/2001	10/18/2001	10		OTH	PVT	Lo/Ovral, Ventolin, Inhaler, Levbid, Zoloft, Allegra, Pantenol	NONE	Asthma, Colitis, Seasonal Allergies, Anxiety			1						1	Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U0684AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177006	11/01/2001	WI	67.0	67		M	10/17/2001	Patient has red, warm, aching area on the right upper arm since 10/16, which measures 7 x 8. The patient had a temp. Area of redness is increasing. The patient will take Benadryl, apply ice, and start antibiotic if area gets larger. There is no temperature today.				Y					Y	10/16/2001	10/16/2001	0		PVT	PVT	ASA, Atenolol, Zocor, FeSO4, Glucosamine Chondroitin	NONE	Allergy to yellow dye, hypertention, hypothyroid, hyperlipidemia, CAD, stroke			1						1	Injection site erythema; Injection site pain; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U0590AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1448K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0177007	11/01/2001	ME				F	10/25/2001	The patient experienced an itchy, macular papular rash on her arms, back and chest.				Y					U	10/24/2001	10/24/2001	0	NONE	OTH	OTH	Vioxx, Allnatol, Paxil, Zanax	NONE	NONE			1						1	Pruritus; Rash macular; Rash papular	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1044L~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0177008	11/01/2001	SD	7.0	7		F	10/12/2001	Hives began on knees this a.m. and have spread all over her body. Patient is being treated with Epinephrine and Claritin.									Y	10/11/2001	10/12/2001	1	NONE	PVT	PVT	NONE	NONE	Strep			1						1	Urticaria	FLU3~SANOFI PASTEUR~U0672AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1197K~1~IM~RL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177009	11/01/2001	WI	78.0	78		F	10/22/2001	On 10/17/2001 the patient experienced right upper quadrant pain and gas. On 10/18/2001 in the P.M. the patient developed hives and itching of the arms and legs. This continued occasionally through 10/21/2001.									Y	10/16/2001	10/17/2001	1	NONE	PVT	PVT	Tagamet, Synthroid, Maalox, Allegra	NONE	Allergies, Sulfa, Doxycycline, Penicillin, Erythromycin, Floxin			1						1	Abdominal pain upper; Flatulence; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0590AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177010	11/01/2001	MA				F	10/25/2001	Post vax, the patient experienced a red area below the injection site the size of a silver dollar. The area was warm to the touch but was not raised. The patient feels fine.									U	10/23/2001				UNK	UNK	O'Laughlin Home Care Pharmacy					1						1	Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U0680AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177011	11/01/2001	NJ	71.0	71		F	10/19/2001	Post vax the patient developed a diffuse maculopapular rash.				Y					Y	10/11/2001	10/12/2001	1	Dermatologic Evaluation	PVT	PVT		Rash on arms and legs	Codeine			1						1	Dermatitis; Rash macular; Rash papular	FLU3~EVANS VACCINES~E02741HA~7+~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0177012	11/01/2001	MO	21.0	21		F	10/26/2001	Post vax, the patient had a large 9x9cm, red square which was tender and warm.				Y					U	10/23/2001	10/23/2001	0	NONE	PVT	PVT	Albuterol, Prozac, Coestna, Imitrex	NONE	Asthma, Migraine			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~0692AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1050L~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0177013	11/01/2001	IL	52.0	51		F	10/23/2001	The patient has pain in her upper left arm, with a burning sensation down to the elbow. The patient's temp has been 101F for 2 days. There is swelling at the injection site. The patient is breathless, and feels a weight on her chest. The patient has general body aches. The patient is self-medicated with Tylenol and has had the flu shot in the past without problems.									Y	10/16/2001	10/17/2001	1		PUB	PUB	Claritan D	NONE	Allergy to dander, dust mites and codeine			1						1	Chest discomfort; Dyspnoea; Injection site pain; Injection site swelling; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U0574AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0461L~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177014	11/01/2001	OR	58.0	58		M	10/25/2001	The patient developed knots in his legs 2 days after receiving the flu shot. The knots were gone by the next day. The patient started with a fever, headache, chills, and congestion that evening.  The patient has alot of muscle and joint soreness at the present time.									U	10/19/2001	10/21/2001	2		PUB	PVT	NONE	NONE	NONE			1						1	Arthralgia; Discomfort; Headache; Myalgia; Nasal congestion; Pyrexia	FLU3~SANOFI PASTEUR~U0688AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177015	11/01/2001	OR	73.0	73		F	10/25/2001	The patient had itching at the injection site and became anxious.  Blood pressure was 180/90 and the patient complained of tingling around the lips and a dry, tight throat. The RN contacted the MD and the patient was treated with Benadryl at the site. The patient was monitored for 30 minutes and felt better. The blood pressure reading was 134/78. The patient was instructed to see an MD if further problems or go to the ER if trouble with breathing.									Y	10/16/2001	10/16/2001	0		OTH	PVT	UNK	NONE	The patient has other allergies but none to latex, thimersol or other flu reaction.			1						1	Anxiety; Blood pressure increased; Injection site hypersensitivity; Paraesthesia; Pruritus; Throat tightness	FLU3~SANOFI PASTEUR~U0588AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177016	11/01/2001	OR	20.0			M	10/25/2001	The patient's blood pressure spiked to 190/100 within 20 minutes post vaccination. The patient's face was red and then pale. The patient saw MD at his office and was diagnosed with vasovagal response to the medication. The patient still had a headache the next day.									Y	10/23/2001	10/23/2001	0		OTH	PVT	NONE	NONE	NONE			1						1	Erythema; Headache; Hypertension; Pallor; Syncope vasovagal	FLU3~SANOFI PASTEUR~U0588AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177017	11/01/2001	MI	64.0	64		M	10/22/2001	The patient has shoulder pain, leg weakness and insomnia. The patient is being treated with Naprosyn and Klonopin.									N	09/24/2001	10/05/2001	11	Shoulder x-ray - Negative	PVT	PVT		NONE	COPD, HTN, Hypothyroidism, and High Cholesterol			1						1	Insomnia; Muscular weakness; Shoulder pain	FLU3~SANOFI PASTEUR~U0575AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177018	11/01/2001	MA	54.0	54		F	10/23/2001	Tmax 10:30				Y					Y	10/17/2001	10/18/2001	1		PVT	PVT		MS				1						1	Body temperature increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0177019	11/01/2001	NH	63.0	63		F	10/25/2001	Approximately 2 hours post vax the patient returned to the office with large hives and welts on her extremities and trunk and pruritus.				Y					U	10/24/2001	10/24/2001	0	NONE	PVT	PUB	NONE	Otitis Media	NONE			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0571AD~1~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177020	11/01/2001	UT	72.0	72		M	10/20/2001	The patient has redness and swelling over the injection site.									U	10/20/2001	10/20/2001	0	NONE	OTH	PUB		NONE	Chronic Rhinitis			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~40679BA~7+~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1465K~2~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177021	11/01/2001	FL	65.0	65		F	10/25/2001	On 10/25/01 at 8:50 AM, returned to clinic with complaints of fever, chills, nausea and diarrhea. Pt also had general muscle aching which started @ midnight. Also complained of right deltoid pain and it appears bruised and slightly swollen @ injection site. CBC was repeated.				Y					U	10/23/2001	10/25/2001	2	10/23/01 WBC 7.5 and UA was negative. On 10/23/2001 prior to injections, temperature was 99.3	PVT	PVT	Klonopin, Premarin, Vioxx, Prevacid, Percocet, Prozac, sulfa, codeine	NONE	Osteoarthritis, degenenerative disc and anxiety			1						1	Chills; Contusion; Diarrhoea; Injection site pain; Injection site swelling; Myalgia; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~U0668AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0923L~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0177022	11/01/2001	NY	71.0	71		F	10/19/2001	The patient experienced arm pain lasting all night. The patient has a headache and aches all over.  The patient had a previous reaction in 1993 to flu vaccine. The patient has received the vaccine yearly since then with no ill effects.									Y	10/16/2001	10/18/2001	2		PVT	PVT	Celebrex, Hydrodiuvil, Insulin, Inderal, Tomoxifen	Breast Cancer	Motrin, Claritin	1993~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Headache; Injection site pain; Pain	FLU3~SANOFI PASTEUR~U0682AA~7+~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177023	11/01/2001	NY	48.0	48		F	10/23/2001	Post vax, the patient experienced an anaphylactic reaction, including tightening of the throat and dizziness. The patient was treated with epinephrine with good result. Symptoms were resolved within a few hours, although some wheezing remained for a day.									Y	10/01/2001	10/01/2001	0		PVT	PVT	NONE	NONE	NONE			1						1	Anaphylactic reaction; Dizziness; Throat tightness; Wheezing	FLU3~EVANS VACCINES~EO4861KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0177024	11/01/2001	KY	23.0	23		F	10/26/2001	Approximately 12 hours post vax, the patient experienced a fever of 104, a headache, nausea, vomiting and body aches. These symptoms lasted 2 days.									Y	10/02/2001	10/03/2001	1	NONE	PUB	UNK	NONE	NONE	NONE			1						1	Headache; Nausea; Pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U0593AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177025	11/01/2001	MO	31.0	31		F	10/25/2001	30 minutes post vax the patient experienced itching, noticed a rash, and then felt her tongue getting thick. The patient was treated in the ER with an injection in the hip and was advised she probably had a reaction to some component of the vaccine.				Y					Y	10/10/2001	10/10/2001	0	NONE	OTH	PVT	Birth Control Pills, Intel Inhaler, Zyrtec, Serovent, Singulair	NONE	Asthma and hypothyroidism			1						1	Pruritus; Rash; Tongue disorder	FLU3~SANOFI PASTEUR~U0681AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177026	11/01/2001	TX	66.0	66		F	10/23/2001	Post vax, the patient experienced swelling in the left arm.				Y					Y	10/22/2001	10/22/2001	0		PVT	PUB						1						1	Injection site swelling	FLU3~EVANS VACCINES~F00931HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1071K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0177027	11/01/2001	MN	40.0	41		F	07/18/2001	The patient received vaccination 12/28/2000. On 01/01/2001 the patient developed hives all over the body and wheezing. The patient was treated with albuterol, prednisone, Tagamet, Zantac, Accolate, Zyrtec, Allegra and 2 other unspecified antihistamines.  The reporter states the hives are resolved with prednisone, but return when the prednisone is stopped.									U	12/28/2000	01/01/2001	4	UNK	PUB	PVT	Synthroid, Zyrtec	NONE	UNK		HQ2062414JUN2001	1						1	Urticaria; Wheezing	FLU3~PFIZER\WYETH~4008207~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0177028	11/01/2001	GA	61.0	60		F	09/06/2001	The patient was vaccinated 11/08/2000. Concomitant medication included Synthroid, estrogen and Prevacid. Subsequent to the vaccine, the woman developed pain at the injection site that keeps her awake. No additional information was available as of the date of this report.									U	11/08/2000			UNK	OTH	OTH	Conjugated Estrogens, Prevacid	NONE	UNK		HQ4378208AUG2001	1						1	Injection site pain	FLU3~PFIZER\WYETH~4008174~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0177029	11/01/2001	HI	20.0	19		M	04/20/2001	7 syncopal episodes lasting less than 1 minute over 11 months (last one in 6/00). Episodes began with heat exhaustion during road march in late February or early March/2000. Second episode occurred in 4/00, again with 12 mile road march. Our pt had evaluations by cardiology, pulmonary, endocrine and psychology specialists and no etiology has been identified as a cause. Another soldier in his unit was discharged and had syncopal episodes as well.				Y					U	01/11/2000	03/01/2001	415	Holter monitor; ECG; EHG; EKG; PPT's all tests were nml; Labs-all nml	MIL	MIL	NONE	NONE	NONE			1						1	Heat exhaustion; Syncope	ANTH~EMERGENT BIOSOLUTIONS~FAV044~2~SC~LA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~1~IM~~HEP A (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~1~IM~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|YF~CONNAUGHT LABORATORIES~7347AD~1~SC~~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0177030	11/01/2001	TX	39.0	39		F	02/19/2001	Started having problems with right elbow and started dropping her weapon.									U	12/03/1999	12/17/1999	14	UNK	MIL	MIL	UNK	UNK	NONE			1						1	Asthenia	ANTH~EMERGENT BIOSOLUTIONS~FAV038~3~SC~~ANTHRAX (BIOTHRAX)~1|FLU3~CONNAUGHT LABORATORIES~OU166AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177119	11/02/2001		4.0	4		M	10/21/2001	On 10/16/01, the pt's parent reported a severe cellulitis on their son's arm, located below the deltoid and above the elbow, at the site of the injection. The pt was seen by a physician on 10/17/01 when the cellulitis area was determined to be approx. 11.5cm by 12.5cm in size. The event was considered to be Medically Significant. The physician prescribed oral onphalexin antibiotic to treat the cellulitis. The event was still ongoing at the time of reporting. The reporter has assessed the relationship of study medication to the event as probable.									N	10/15/2001	10/16/2001	1		UNK	UNK	Zantac; Albuterol; Intal				PJP2001003420	1						1	Cellulitis; Injection site reaction	FLU3~EVANS VACCINES~~3~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0177122	11/02/2001	AR	10.0	10		M	10/22/2001	Post vax the patient developed a 3-4cm red induration at the injection site with a small patchy area of pruritic rash. Treated with Ibuprofen and Cortisone. Patient to call clinic if worsens.									Y	10/19/2001	10/21/2001	2	NONE	PVT	PVT			Asthma			1						1	Injection site induration; Rash pruritic	FLU3~SANOFI PASTEUR~U0594AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177123	11/02/2001	ME	40.0	40		F	11/11/2001	Post vax the patient reported heart pounding in her chest and difficulty taking a breath. The patient was treated with epininephrine. Call 911 and transferred patient to emergency dept.				Y					Y	10/30/2001	10/30/2001	0	NONE	OTH	OTH		NONE			ME01039	1						1	Dyspnoea; Palpitations	FLU3~SANOFI PASTEUR~40679AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177124	11/02/2001	ME	48.0	48		F	11/01/2001	Post vax, the patient developed a rash, hives on her back and neck, and lip swelling. The patient refused treatment. The symptoms started resolving within 45 minutes.									Y	10/31/2001	10/31/2001	0	NONE	OTH	OTH		NONE	PCN, Thimersil sensitivity		ME01038	1						1	Rash; Swelling face; Urticaria	FLU3~SANOFI PASTEUR~U0679AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177126	11/02/2001	NY	56.0	56		F	10/30/2001	The patient started a dry cough with yellowish phlegm on 10/20/2001. Treated with Guaifenex LA.				Y					Y	10/19/2001	10/20/2001	1	NONE	OTH	PVT	Glyset, Synthroid, Enapril, Avandia, Coreg, Glucovane	NONE				1						1	Cough; Infection	FLU3~EVANS VACCINES~E02081HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0177127	11/02/2001	VA	58.0	58		F	10/31/2001	The patient had chills and dizziness. The patient's arm was red and hot with fever. The patient could not raise her arm for 2 days. The patient slept all day Saturday and Sunday and was sore on Monday from laying around. It is now Wednesday and my arm is still red, hurts and has a fever.									N	10/26/2001	10/27/2001	1		OTH	OTH	Celebrex, Singulair, Premarin, Accupril, Medroxyprogesterone	NONE				1						1	Chills; Dizziness; Erythema; Joint range of motion decreased; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1448K~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177128	11/02/2001	CO	39.0	39		F	10/17/2001	Post vax the patient developed a painful area of redness and slight induration over the injection site about 8cm in diameter. The patient complained of a flare up of carpal tunnel syndrome with wrist and forearm pain, and paresthesis in the first 3 fingers.				Y					U	10/15/2001	10/16/2001	1		MIL	MIL	OCP's, Serevent, Beclovent, Proventil		Asthma, Carpal Tunnel Syndrome			1						1	Carpal tunnel syndrome; Injection site erythema; Injection site induration; Injection site pain; Paraesthesia	FLU3~SANOFI PASTEUR~U0674AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177129	11/02/2001	NY	24.0	24		F	10/23/2001	Post vax, the patient developed tingling in her fingers and numbness, swelling and pain of arm.									Y	10/18/2001	10/18/2001	0		UNK	PUB						1						1	Hypoaesthesia; Pain; Paraesthesia; Swelling	FLU3~SANOFI PASTEUR~U0670AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177130	11/02/2001	MD	66.0	66		M	10/30/2001	After receiving 2 vaccines on the same day, the patient developed a local reaction at the pneumovax site with bilateral hand swelling and a fever of 101F. The patient still has these symptoms.									N	10/25/2001	10/25/2001	0		PVT	PVT	Colchicine, Allopurinol, Visteral, Zestril, Cardura	NONE	Allergy to penicillin			1						1	Oedema peripheral; Pyrexia	FLU3~SANOFI PASTEUR~U0599BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1448K~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177131	11/02/2001	WI	55.0	55		M	10/23/2001	Two hours post vax, developed angioedema of the upper lip. Progressed despite treatment with Benadryl. ER treated with epinephrine, IV Benadryl, and prednisone.				Y					Y	10/22/2001	10/22/2001	0		PVT	PVT	Linsinopril, glucophage, lopid, lipitor, thiazide, glynase	NONE	NONE			1						1	Angioneurotic oedema	FLU3~SANOFI PASTEUR~U0712AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177153	11/05/2001	NM	59.0	59		M	10/28/2001	Around 11:30 on 10/2/01, he called his son and said he was dizzy and nauseated and was brought to MD's office with erythema, confusion and lethargy. His BP was 54/40, then 74/30. He was given epinephrine, SC, steroids and IV fluids in ER with full recovery. He also had taken 1 aspirin at 10:00. He is not allergic to eggs. He had taken flu vaccine on 1/11/01 without problem and previous aspirin also.			Y	Y					Y	10/02/2001	10/02/2001	0		PVT	PVT	ASA	NONE	High BP; ASHD; Hypothyroidism			1						1	Confusional state; Dizziness; Erythema; Hypotension; Lethargy; Nausea	FLU3~EVANS VACCINES~E02761HA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening	Influenza
0177159	11/05/2001	MA	37.0	37		F	11/02/2001	Vaccine given at approximately 10:45am. Symptoms of tingling accompanied by brief sharp pain (1-2 seconds duration) occurred intermittently within twenty minutes of injection. This has repeated 6 - 7 times until now (3pm). Pain and tingling occurs left lower pelvic region and starts to radiate to left upper thigh.									U	11/02/2001	11/02/2001	0		OTH	OTH	NONE					1						1	Pain; Paraesthesia; Pelvic pain	FLU3~SANOFI PASTEUR~U0682AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177160	11/05/2001	CA	44.0	44		F	11/01/2001	70cmx60cm red area (knot) on upper arm, warm to touch, developed about 48 hours after administration of vaccine. Treatment ice and Ibuprofen. Reported to Occupational Health Nurse.									Y	10/30/2001	11/01/2001	2	NONE	PUB	PVT		NONE	Pt had allergic reaction to Thimersal in contact lens solution about 20 years ago. Seasonal allergies, takes Claritin.			1						1	Erythema; Feeling hot	FLU3~SANOFI PASTEUR~U0573AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177161	11/05/2001	TX		69		M	10/26/2001	Flu had to get treatment from doctor.				Y					N	10/11/2001	10/14/2001	3		PUB	PVT		NONE	Emphysema			1						1	Influenza	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0177162	11/05/2001	IL	62.0	62		F	10/30/2001	Rash to upper extremities and neck. Pt not on any other meds.									Y	10/04/2001	10/05/2001	1	NONE	PUB	UNK	Avapro and questionable Allergy Shots	NONE	NONE			1						1	Rash	FLU3~SANOFI PASTEUR~U0574AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177163	11/05/2001	TX	68.0	68		F	10/26/2001	Flu had to go to ER for treatment. Got ill 3 days after receiving shot, I am still sick.				Y					N	10/11/2001	10/14/2001	3		PUB	PVT		NONE				1						1	Influenza	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0176931	11/06/2001	IN	68.0	68		F	11/01/2001	Circumferential redness, edema and tenderness in left upper arm. Treatment: Oral dose of Allegra, 180mg.				Y					Y	10/16/2001	10/17/2001	1		OTH	OTH			Post breast cancer pt			1						2	Hypersensitivity; Injection site oedema; Vasodilation procedure; Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U0899BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1448K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0177204	11/06/2001	DE	51.0	51		F	11/02/2001	GBS, onset approx. 10/30/01; currently hospitalized. Ongoing. Per doc 211932, 60 Day follow Up, GBS with rediagnosis of CIDP, also states that patient walks bu still has neuropathies and residuals. The annual follow up states, Developed CIOP, medically on disability. Last known symptom muscular weakeness although ambulatory.					Y				N	10/18/2001	10/30/2001	12	Ongoing	OTH	PVT		NONE				1						1	Guillain-Barre syndrome; Muscular weakness; Neuropathy	FLU3~EVANS VACCINES~E02741HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0177205	11/06/2001	MA	86.0	86		F	10/30/2001	Vomiting, fever, achy, loss of appetite, stomach pain. Given IV's. The discharge summary states weakness, dehydration, vertigo and nausea.				Y	Y	3			Y	10/26/2001	10/26/2001	0	Stomach X-rays	OTH	PUB		NONE	Osteoporosis; inner ear problem, dementia			1						1	Abdominal pain upper; Anorexia; Asthenia; Dehydration; Nausea; Pain; Pyrexia; Vertigo; Vomiting	FLU3~SANOFI PASTEUR~U0571AD~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0177209	11/06/2001	OR	48.0	48		F	10/25/2001	At 1000, pt feeling shaky, different, feeling like going to fall. At 1050, lips itching, pruretic macular red areas on neck, no SOB. At 1115, scratchy throat. At 1125, scratchiness gone. At 1145, symptoms have ceased. At 1105, Sdrimedrol 125mg IV, Benadryl 25mg IV. Then Prednisone 6 tabs this afternoon, then 5,4,3,2,1.				Y					Y	10/17/2001	10/17/2001	0	NONE	PUB	PVT	Pevacid 30mg, Premarin, Lamotal 200mg and vitamins.	NONE	Asthma, GERD, depression, Post menopausal and no allergies.			1						1	Dizziness; Pharyngitis; Pruritus; Rash maculo-papular	FLU3~SANOFI PASTEUR~UO596CA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177210	11/06/2001	NY		37		M	10/26/2001	Client got pneumonia shot on 10/23/2001 and right arm swelled, redness and pain.				Y					Y	10/23/2001	10/23/2001	0		UNK	PVT		NONE	NONE			1						1	Oedema peripheral; Pain; Vasodilation procedure	FLU3~EVANS VACCINES~FE02761~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0469K~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0177211	11/06/2001	MO	53.0	53		M	10/29/2001	Generalized rash.									Y	10/22/2001	10/24/2001	2		OTH	PVT	NONE	NONE	NONE			1						1	Rash	FLU3~EVANS VACCINES~E04831KA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0177212	11/06/2001	CA	58.0	58		F	10/02/2001	Swollen arm 15 minutes after administration of vaccine. Bad headaches 4 days, disrupting sleep and work.									U	09/28/2001	09/28/2001	0		OTH	PVT	NONE					1						1	Headache; Insomnia; Oedema peripheral	FLU3~SANOFI PASTEUR~UO592AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177213	11/06/2001	NY	88.0	88		M	10/29/2001	Pt present to clinic with facial swelling, edema and tenderness. Pt states he started with symptoms 1 hour after flu injection. Treatment consisted of tapering doses of Prednisone.				Y					Y	10/19/2001	10/19/2001	0		PVT	PUB	MOV, Toprolx L, Lasix, Prinivil, Cooumedin and ASA		CHF, Cardiomyopathy, Atnalfib and anemia.			1						1	Face oedema; Oedema; Pain	FLU3~EVANS VACCINES~E00951HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0177214	11/06/2001	CA	47.0	0	.1	F	10/24/2001	Swelling, painful, vomited last night, chills, fever and pain under left armpit. Saw MD (states increased stress lately).				Y					U	10/23/2001	10/23/2001	0		UNK	PUB	Medq-Myselene (seizures),  Procardia (Increased BP).	NONE	Seizure disorder and hypertension.		CA010122	1						1	Depression; Pain; Pyrexia; Swelling; Vomiting	FLU3~SANOFI PASTEUR~UO592AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~476951~1~IM~LA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0177215	11/06/2001	CA	58.0	68		F	10/25/2001	High fever, joint aches, chills (next day), left arm edema, redness, hot to touch and edema great enough to hide elbow. One week later pt still feels tired.									Y	10/18/2001	10/18/2001	0		PUB	PUB	HCTZ 25mg and potassium supplement.	NONE	Seasonal allergies, no medical conditions.		CA010121	1						1	Arthralgia; Asthenia; Injection site oedema; Pyrexia; Vasodilation procedure	FLU3~SANOFI PASTEUR~UO684AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~476951~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0177216	11/06/2001	CA	53.0	53		F	11/01/2001	Employee received flu vaccine on 10/24/2001 at around 10am. She stated when she arrived home she felt pain, redness, swelling and aching all the way down to finger tips (dull ache). She immediately applied ice pack on and off. On 11/02/2001, complained of soreness and pain to touch on RA.									Y	10/24/2001	10/24/2001	0		PUB	UNK						1						1	Myalgia; Oedema; Pain; Vasodilation procedure	FLU3~SANOFI PASTEUR~UO601AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177217	11/06/2001	WA		51		F	10/26/2001	Pt developed a 12 x 6 cm area of redness, swelling and warmth to touch on left arm.				Y					U	10/24/2001	10/24/2001	0		OTH	PVT	Lortab, Zoloft, Premarin	NONE	NONE			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U0679BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177218	11/06/2001	NJ	41.0	41		F	10/29/2001	Extreme pain in the right arm. She couldn't move her arm for 3 days.									Y	10/17/2001	10/17/2001	0		PUB	PUB	Prevacid, Vitamin E, Miralak, Coace and Claritin.	NONE	Pemphegoid,Tumor removed from spine recently.			1						1	Hypokinesia; Pain	FLU3~EVANS VACCINES~E02741HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0944K~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177219	11/06/2001	IL	71.0	71		F	10/26/2001	Rapid heart rate 4.5 to 5 hours after flu vaccine. No treatment.									Y	10/02/2001	10/05/2001	3		PVT	OTH		NONE				1						1	Tachycardia	FLU3~SANOFI PASTEUR~U0574AAA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177220	11/06/2001	VA	89.0			F		Local reaction upper arm (deltoid muscle) area appeared dark red. Was given Tylenol and cold compresses.									Y					UNK	PVT						1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U0677AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177221	11/06/2001	LA	31.0	31		F	11/01/2001	Eight hours after Fluzone, was having a disagreement with husband, out of the ordinary, throwing things, banging hands on table, driving away without shoes, some events she did not remember doing.									U	10/29/2001	10/29/2001	0		PVT	PVT	Wellbutrin and Tenormin	NONE	PMS and HTN			1						1	Aggression; Agitation; Amnesia	FLU3~SANOFI PASTEUR~UO5755AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177222	11/06/2001	CA	31.0	31		F	10/30/2001	Pt felt warm feet and numbness of lips and body. Treated with Benadryl only.				Y					Y	10/27/2001	10/27/2001	0		PVT	PVT		NONE	NONE			1						1	Paraesthesia; Vasodilation procedure	FLU3~SANOFI PASTEUR~U0592AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177223	11/06/2001	MI	38.0	38		M	10/25/2001	Generalized myalgias, arms, shoulders, legs and elevation of liver enzymes (SGOT and SGPT).				Y					Y	10/09/2001	10/11/2001	2	SGOT increased to 71 (normal 0-37) and SGPT increased to 47 (normal 0-40).	PVT	PVT	Zestril (Lisimopril)	Hypertension (controlled)	Hypertension (controlled)			1						1	Myalgia	FLU3~SANOFI PASTEUR~UO591EA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177224	11/06/2001	MO	45.0	45		M	10/31/2001	11/01/2001 Telephone call, continued to have dull headache, back to work.									Y	10/26/2001	10/29/2001	3	NONE	OTH	UNK	Avendol, Trezedone and Desipreanine.	NONE	NONE			1						1	Headache	FLU3~SANOFI PASTEUR~U0574AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177226	11/06/2001	IL	72.0	72		M	10/18/2001	Pt's right upper arm was red, swollen and hot to the touch. Pneumococcal injection given in right deltoid on 10/16/01. Pain in arm started on evening of 10/16/01.				Y					U	10/16/2001	10/16/2001	0		PUB	PUB	Toprol 50mg; Celebrex 300mg; Diovan 160mg; indomethacin		Allergy to Dawn soap			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U0590A2~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0177227	11/06/2001	IL	69.0	69		F	10/22/2001	Pt received vaccine around 10:30 and at approx. 16:00 that evening, she started feeling achy, possible fever and diarrhea started the following day (10/20/01).									Y	10/19/2001	10/19/2001	0		PUB	PVT		NONE	NONE		IL01045	1						1	Diarrhoea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U0672AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177228	11/06/2001	CT	40.0	40		F	10/31/2001	Pt received vaccine on 10/22/01. On 10/25/01 c/o flu like symptoms, cough, hoarseness, SOB upon exertion decreased energy. Afebrile. Monitor S/S, rest. Teacher to F/U with PCO if S/S persist.									Y	10/22/2001	10/25/2001	3	N/A	OTH	OTH		N/A	N/A			1						1	Asthenia; Cough; Dysphonia; Dyspnoea; Influenza like illness	FLU3~SANOFI PASTEUR~U0693AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177229	11/06/2001	TX	29.0	29		F	10/30/2001	Rash to injection site painful, edematous area approx. size of half dollar coin.									Y	09/22/2001	09/23/2001	1	NONE	PVT	PVT	Singulair 10mg dly	NONE	Asthma no drug allergies			1						1	Injection site pain; Injection site rash; Oedema	FLU3~EVANS VACCINES~~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0177230	11/06/2001	CA	26.0	26		F	10/30/2001	Vaccine given 10/23/01. On 10/25/01 F.A noted painful sensations of heat/cold numbness tingling in the left anterior/medial deltoid area. Has had past flu vaccines with reactions. NO local tenderness, erythema, heat or nodularity.									U	10/23/2001	10/25/2001	2		PUB	PUB	Servent, azmacort/allegr		NKDA, cats, seasonal pollens, grass, asthma			1						1	Feeling cold; Hypoaesthesia; Injection site pain; Injection site warmth; Paraesthesia	FLU3~SANOFI PASTEUR~U0573AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177231	11/06/2001	GA	44.0	44		F	10/31/2001	Pt c/o hard knot at injection site with slight soreness. No c/o redness or fever.									Y	10/29/2001	10/30/2001	1		PUB	PVT		NONE	Sulfa			1						1	Injection site induration; Pain	FLU3~EVANS VACCINES~EO5221KA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0177232	11/06/2001	WI	19.0	19		F	10/30/2001	1st day golf ball size lump with redness and purple with warmth around area. 2nd day lump grew to soft ball size w/redness, purple and swelling. Felt Warm to touch. 2nd started on Augmentin day 3 lump size going down.									Y	10/19/2001	10/20/2001	1	NONE	PVT	PVT	NONE	NONE	allergy to Biaxin, Crohn's disease			1						1	Injection site erythema; Injection site mass; Injection site warmth	FLU3~SANOFI PASTEUR~U0672AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177233	11/06/2001	WA	60.0	60		M	10/31/2001	Within hours of injection R arm sore, by 6 hrs later some what red, mildly, tender. TX - for comfort acetaminophen.									Y	10/22/2001	10/22/2001	0		PVT	UNK		Liver transplant, immunosuppressed	cirrhosis,  ? (resolved after transplant 6/00)			1						1	Injection site erythema; Tenderness	FLU3~SANOFI PASTEUR~U0573AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~473555~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0177234	11/06/2001	WA	42.0	41		F	10/26/2001	Pt stated there is pain since injection and began with a egg sized lump at injection site. Continues with pain and R arm is swollen form shoulder down, C/O severe pain, redness and weakness.									U	10/25/2001	10/25/2001	0	NONE	PVT	PVT	PPD- R arm					1						1	Asthenia; Injection site erythema; Injection site mass; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~UB588AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0944K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177235	11/06/2001	CA	27.0	27		M	11/01/2001	Had flu vaccine administered 10/31/01 and developed sore throat, achy, temp, sore muscles axilla area L arm. 14 hrs after vaccine given.										10/31/2001	10/31/2001	0		PVT	PVT	Hydrocodone PRN, Soma PRN	NONE	Chronic asthma			1						1	Myalgia; Pain; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U0573AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177236	11/06/2001	TX	34.0	34		F	10/29/2001	Teeth started hurting, vision blurred									Y	10/29/2001	10/29/2001	0		PUB	OTH						1						1	Tooth disorder; Vision blurred	FLU3~SANOFI PASTEUR~U0598AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177237	11/06/2001	NC	1.6	1	.7	F	10/27/2001	Lt thigh - 1/2 cm x 3cm erythema, confluent,NT area no fever. At injection site. Tx 1 - cool compress, motrin q6 hrs, f/u prn if worsens.				Y					Y	10/25/2001	10/26/2001	1	N/A	PVT	PUB	Synthyroid	NONE	Congenital hypothyroidism, piriform stenosis			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U0593AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~480898~1~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0177238	11/06/2001	IN	3.0	3		F	10/30/2001	Developed a local reaction 5cm at site of immunization.									U	10/29/2001	10/30/2001	1	N/A	PVT	UNK		NONE	NONE			1						1	Injection site reaction	FLU3~SANOFI PASTEUR~U0697AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~484134~UNK~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0177239	11/06/2001	IN	3.0	3		F	10/30/2001	4x9cm red swollen area surrounding the area of immunization appeared the did next day.									U	10/29/2001	10/30/2001	1	NONE	PVT	OTH		NONE	NONE			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U0697AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~484134~UNK~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0177293	11/07/2001	SC	53.0	53		F	11/30/2001	Information has been received on 10/23/01 from a health professional concerning a 53 year old female who on 10/11/01 was vaccinated with the standard dose, 0.5ml, of pneumococcal vaccine 23 polyvalent (lot 637487/1071K) and 1 dose of influenza virus vaccine. On 10/15/01, the pt went to the MD's office with a local reaction that was described as an area at the injection site that was swollen, red and hot. The pt also had symptoms of a sinus infection, with a cough and a fever. She was dx'd with cellulitis and was prescribed Augmentin for the sinus infection and the cellulitis, Atuss and Medrol. It was noted that the pt is fine now and has fully recovered. The reporter noted that the practice had been administering the pneumococcal vaccine 23 polyvalent vaccine for years and they have never had a problem. It was also noted that another pt (WAES 01106301) who was vaccinated from the same lot developed similar events. The reporter stated that she and another nurse are now concerned and afraid to use the rest of the lot. The reporter stated that she was grateful that a check would be done on this lot and reported that their practice would not administer any more of the vaccine until they received information on the results of the lot check. The records of testing prior to release of this lot have been checked by compliance and found to be satisfactory. This lot complies with the standards of the CDC and was released. Upon internal review, the pt's cellulitis was considered to be an Other Important Medical Event. Additional information has been requested. F/U states the pt was also prescribed Augmentin for the sinus infection.				Y					Y	10/11/2001	10/15/2001	4		PVT	PVT	Lipitor; clonazepam; Prozac; Xenical		Heavy smoking (1-2 ppd) and no allergies		WAES01103264	1						1	Cellulitis; Cough; Injection site erythema; Injection site swelling; Injection site warmth; Pyrexia; Sinusitis; Cellulitis; Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1071K~1~IM~~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~071K~1~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0177305	11/07/2001	MO	56.0	56		M	10/31/2001	Pt developed a fever of 102.4F max, several rigors, headache, nausea and severe achiness in the left arm. Treatment: Tamiflu, droperidol, Toradol and Tylenol. Pt felt better at discharge. Dx'd with viral illness (monocytosis).					Y	1			Y	12/18/2000	12/18/2000	0	On 12/19/00 WBC-3,200; Platelets-111,000; on 12/20/00 WBC-3,100; Platelets-94,000	OTH	OTH	Prevacid; Vitamin B; Multi-vitamins; ASA	Possible viral illness-monocytosis	Bladder cancer; recent viral meningitis (9/00); Status post chemo; Viral infection			1						1	Chills; Headache; Monocytosis; Nausea; Pain; Platelet count decreased; Pyrexia; White blood cell count decreased	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0177308	11/07/2001	TX	91.0	91		F	10/31/2001	The patient rapidly developed respiratory failure with oxygen desaturation days after receving the vaccination. Annual follow up states that pt did not recover. Replied to your letter dated 06/26/02 by fax on 07/17/02. Death certificate sent, as requested. Annual follow up on 11/25/03: It is unknown if the patient recovered from the adverse event. Death Certificate Info: Immediate cause: Pneumonia. Underlying cause: Advanced Dementia. Significant Conditions: Diabetes Follow up on 06/01/2004: states it is unknown if the pt recovered from the adverse event.	Y		Y						U	10/22/2001	10/29/2001	7		OTH	MIL					SA0113	1						1	Dementia; Pneumonia; Respiratory failure	FLU3~SANOFI PASTEUR~U0674AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0177309	11/07/2001	TX	84.0	84		F	10/31/2001	The patient rapidly developed respiratory failure and oxygen desaturation days after vaccination. Transferred to hospital. Per F/U on 6/25/02: immediate cause of death; respiratory failure and pneumonia.	Y	11/09/2001	Y		Y				U	10/22/2001	10/29/2001	7		OTH	MIL	Zoloft, Deparene, Phenobarbitol, Cogentin, Premarin		Dementia, Hypertension, Hypothyroidism		SA0112	1						1	Apnoea; Pneumonia; Respiratory failure	FLU3~SANOFI PASTEUR~U0674AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0177310	11/07/2001	WV	72.0	72		F	11/06/2001	The patient became lightheaded and dizzy 4 hours post vax. The patient experienced nausea and vomiting during the night, which abated by the next morning.									Y	10/18/2001	10/18/2001	0		PUB	PUB	Cholesterol Inhibitor, Hormones	NONE	Hypercholesterolemia, osteoporosis and arthritis			1						1	Dizziness; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U0670AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177311	11/07/2001	OH	35.0	35		M	10/25/2001	Post vax, the patient experienced local erythema and pain on the right deltoid.									U	10/22/2001	10/22/2001	0	NONE	OTH	OTH	Advair, Accolate, Zestril, Claritin, and Proventil	NONE	RAD, DM II, HTN, Hypercholesterolemia, SAR			1						1	Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U0679BA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1456K~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177312	11/07/2001	CA	51.0	51		F	10/22/2001	The patient experienced swelling, pain, and a fever at the injection site.				Y					U	10/19/2001	10/20/2001	1		PVT	PUB		NONE	Sulfa, Tetanus Vaccine		CA010119	1						1	Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U0682AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1449K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0177313	11/07/2001	LA	63.0	63		F	10/24/2001	Post vax, the patient experienced feeling funny, lips tingling, sore across shoulder and arm. The next day the patient experienced body pain, headache, sore throat. The next day the patient was nauseated, extra tired, had an earache, and nasal passages were stopped up. The patient also experienced coughing and feeling like she is coming out of her skin, sneezing, a bad taste in her mouth, dizzy and a stomach ache. The patient's heart was beating faster with heavy breathing. The patient was also hot then cold. The patient was treated with an antibiotic.				Y					U	09/29/2001	09/29/2001	0		OTH	PVT	Zantac, Tylenol, Excedrin, Estrace Cream, Monistat, Vagisil, Citrucil, Refresh for Eyes, Aspirin, Nasal Crom.	Herpes	Allergies, fibromyalgia, arthritis, IBS, osteoporosis			1						1	Abdominal pain upper; Cough; Dizziness; Dysgeusia; Dyspnoea; Ear pain; Fatigue; Feeling abnormal; Headache; Heart rate increased; Nasal congestion; Nausea; Pain; Paraesthesia; Pharyngolaryngeal pain; Shoulder pain; Sneezing	FLU3~SANOFI PASTEUR~U0594AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177314	11/07/2001	CA	53.0	53		F	11/01/2001	Post vax, the patient experienced injection site erythema, pain and edema. The patient was treated wtih cool compress and NSAID.									Y	10/31/2001	10/31/2001	0		PUB	UNK	Hydrocortisone		Addison's Disease, Asthma			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U06814A~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177315	11/07/2001	WA	62.0	62		M	10/31/2001	Post vax the patient developed redness, swelling, heat and pain at the injection site.									U	10/30/2001	10/30/2001	0	NONE	PVT	PVT						1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U0688AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0944K~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177316	11/07/2001	IL	6.0	6		F	10/31/2001	Post vax the patient was brought to the office with a rash. There were multiple macules 1mm, red raised areas surrounding 1 1/2 cm clearing surrounding the injection site. The site itself had redness, warmth and swelling. The patient was treated with Claritin.									U	10/25/2001	10/30/2001	5	NONE	PVT	PVT	Singulair, Proventil, Flovent	Bronchitis	Asthma			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Rash erythematous; Rash macular	FLU3~SANOFI PASTEUR~U0574AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177317	11/07/2001	KS	88.0	88		M	10/30/2001	Post vax the patient's arm was swollen from the injection site down to the elbow. The patient was treated with Benadryl.									Y	10/24/2001	10/25/2001	1	NONE	PVT	PVT		NONE	Cardiac Dsyrhythmia, CAD with CABG, Prostate Cancer			1						1	Injection site swelling	FLU3~EVANS VACCINES~E00971HA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0177318	11/07/2001	WI	58.0	58		F	10/23/2001	Post vax, the patient developed a fever, fatigue, myalgia, nausea, loose stools and chills.									Y	10/17/2001	10/19/2001	2		PVT	UNK		NONE	NONE			1						1	Diarrhoea; Fatigue; Myalgia; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~U0670AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177319	11/07/2001	WA	83.0	82		F	10/31/2001	Post vax, the patient developed pain in the left arm radiating up to the neck. The patient was treated with ice.				Y					Y	10/30/2001	10/30/2001	0		PVT	UNK	Stool Softners, MUI	NONE	Iodine, Hyperlipidemia, HTN, asbestos exposure, Right renal cell carcinoma, colon cancer, EGD			1						1	Injection site pain; Neck pain	FLU3~SANOFI PASTEUR~U0688AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0944K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0177320	11/07/2001	WI	48.0	58		F	10/30/2001	The patient experienced a fever, chills, myalgia, nausea and fatigue after vaccination.									Y	10/17/2001	10/19/2001	2	NONE	PVT	UNK		NONE	NONE			1						1	Fatigue; Myalgia; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~U0670AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177321	11/07/2001	CT	19.0	19		F	10/30/2001	Patient presented 24 hours after flu shot with a headache, fever of 100.6 and myalgia.									Y	10/25/2001	10/25/2001	0	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Headache; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U0671EA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177322	11/07/2001	SC	47.0	47		F	10/31/2001	Post vaccination the patient developed aching in all joints, especially arms and no energy.									U	10/15/2001	10/29/2001	14	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Arthralgia; Asthenia	FLU3~SANOFI PASTEUR~U0673BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177323	11/07/2001	NY	82.0	82		M	10/29/2001	After vaccination on 10/23/2001 the patient developed pruritis and a rash all over his body, except his face. The patient was treated with Benadryl.									Y	10/23/2001	10/23/2001	0		OTH	PVT		Lymphoma	diabetes, cardiac disease, myasthenia gravis, HBP			1						1	Pruritus; Rash	FLU3~EVANS VACCINES~E02761HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0177324	11/07/2001	KS	34.0	34		F	11/06/2001	Staff ARNP here received flu shot and had anaphylactic reaction. 2 other staff members had allergic reaction (itching).									Y	11/06/2001	11/06/2001	0		PUB	OTH	NONE	NONE	Allergy to ASA			1						1	Anaphylactic reaction; Dysphagia; Eye irritation; Swelling face; Throat tightness	FLU3~PFIZER\WYETH~4018033~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4018033~UNK~IM~GM~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0177375	11/07/2001	IL	53.0	53		M	10/30/2001	Pt noted a firm area below left deltoid with moderate edema down to elbow.				Y					Y	10/25/2001	10/28/2001	3	NONE	PVT	OTH		NONE	NONE			1						1	Injection site induration; Injection site oedema	FLU3~SANOFI PASTEUR~U0672AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1070K~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0177381	11/08/2001	MN	67.0	67		M	11/01/2001	The pt's son reported that the pt, a 67 year old man, received a Fluzone vaccination, lot U0673FA, on 10/30/01. On 10/31/01, the pt experienced some form of seizure activity that resulted in hospitalization in the ICU on ventilation support. The physician is conducting further testing to establish the cause. Etiology to be determined.					Y				U	10/30/2001	10/31/2001	1		OTH	OTH		CT Scan was neg. Tests conducted for myocardial infarction were neg at this time but showed cardiac arrhythmia of frequent premature ventricular contractions.			U2001011060	1						1	Convulsion; Ventricular extrasystoles	FLU3~SANOFI PASTEUR~U0673FA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0177382	11/08/2001	GA	78.0	69		M	11/01/2001	It was reported by the pt's wife that her husband, a 78 year old man received a Fluzone '01-'02 vaccination on Friday afternoon, 10/26/01. On Sunday, 10/28/01, at 03:45, the pt awoke with a large moan, had a seizure and was taken by EMS to the hospital and was admitted. F/U received on 11/26/01, reports Received letter from Vaers with release forms to send to doctors and hospital. Mailed on 11/11/01 to Vaers in Rockville, MD. (The pt) still has memory lapses and is to be follow-up by a Neurology specialist on 12/11/02. Follow-up with MD on 12/4/01. The hospital is mailing all information.  Follow up on 11/20/2001: This patient has not yet been seen in office.					Y				U	10/26/2001	10/28/2001	2	MRI; EEG; CAT Scan; EKG; X-rays; results not provided; FU states CAT scan, chest xray, EEG, and MRI all WNL	PVT	OTH	Effexor, verapamil	NONE	Degenerative joint disease, HTN, GERD; F/U states: Arthritis in knees		U2001011030	1						1	Convulsion; Memory impairment	FLU3~SANOFI PASTEUR~U0684AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0177383	11/08/2001	PA	21.0	21		F	11/05/2001	On 10/22/01, by 21:00, pt had left back muscle spasms, weakness of left arm, left arm soreness (deltoid) muscle; progressed by 10/23/01 to inability to raise left hand or arm, increased left back pain, decreased sensation on left side of body from shoulder to foot. On 10/24/01, the left leg, left foot, left chest, left back, left arm and shoulder had weakness.				Y				Y	N	10/22/2001	10/22/2001	0	Serum chemistry; ANA; Sed Rate; CBC; MRI of brain and spinal cord	PVT	PVT	Plaquenil; Prevacid; Colexa	NONE	SLE			1						1	Back pain; Hemiparesis; Hypokinesia; Injection site pain; Muscle spasms; Sensory disturbance	FLU3~SANOFI PASTEUR~U0680AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0177385	11/08/2001	GA	30.0	30		F	10/26/2001	In early AM 10/24/2001, pt's spouse states pt made gasping noise and then quit breathing. Spouse gave 2 rescue breaths and pt started gasping. Pt then stiffened up and tight hand curled inward. Pt had 2 episodes of this lasting about 25 minutes and then had period of confusion. Was transported to medical center and had CT scan that was negative. F/U with neurologist and he classified this as a non conclusive seizure.				Y					Y	10/23/2001	10/24/2001	1	Negative CT scan 10/24/2001	PUB	UNK		Brief episodes of nausea and mild dizziness w/menses 10/20/2001	Back problems		GA01099	1						1	Convulsion; Dyspnoea; Respiratory arrest	FLU3~EVANS VACCINES~E04841KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0177386	11/08/2001	GA	61.0	61		M	10/22/2001	Client received flu shot at health department in morning. Early afternoon wife called saying he was having a reaction to flu shot, dizzy, vomiting, sweaty. Referred to PMD wife called and said MD said it was reaction to flu shot. This was client's first flu shot. Has history of bronchial problems. PC 10/23/2001 pt fine, no more problems.									Y	10/22/2001	10/22/2001	0		PUB	PUB			UNK Possible bronchial problems.		GA01092	1						1	Bronchitis; Dizziness; Hyperhidrosis; Vomiting	FLU3~EVANS VACCINES~E05221KA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0177387	11/08/2001	GA	57.0	57		F	10/19/2001	After receiving vaccine the next am pt developed large amount of swelling in right arm, size of baseball, temp 103, severe headache and back pain.									Y	10/16/2001	10/17/2001	1		PUB	PUB		NONE			GA01091	1						1	Back pain; Headache; Oedema; Pyrexia	FLU3~EVANS VACCINES~E04841GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0946K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177388	11/08/2001	NY	62.0	62		F	11/05/2001	Some slight swelling at sight of flu shot. Increased swelling at sight of pneumonia shot eventually growing from size of golf ball in circumference to an orange. Difficulty in raising my arm due to some pain. Red rash covered area and although faded quite a bit, still remains. Both shots in right arm due to node dissection left arm (breast cancer). Saw internist on 10/31/2001. Diagnosis allergic reaction. 21 pack 4mg methylprednisone tabs;Benadryl and Levaquin due to shortness of breath.				Y					U	10/29/2001	10/29/2001	0		OTH	UNK	Aciphex, tamoxifen, synthroid	NONE	Mold spore, dust mite, reflux, breast cancer (radiation)			1						1	Dyspnoea; Injection site oedema; Pain; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0177389	11/08/2001	PA	32.0	32		F	11/01/2001	Employee called 11/01/2001 to report that she had developed left ear pain and achy neck accompanied by left shoulder discomfort which started Tuesday 10/30/2001. Injection given in left deltoid on Monday 10/29/2001. Also c/o left rib cage pain with a deep breath. Left arm no swelling, tenderness or redness. Physician notified, informed to take ibuprofen which she did. On 11/02/2001 she felt much better, no longer had left rib cage or shoulder pain. Still had a little ear and neck discomfort but improved since yesterday. Left deltoid looks fine, no redness or warmth, has full range of motion.									Y	10/29/2001	10/30/2001	1	NONE	PUB	PVT	NONE	NONE	Topical allergies, never tested (eg. make up)			1						1	Chest pain; Ear pain; Neck pain; Pain	FLU3~SANOFI PASTEUR~UO675BA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177390	11/08/2001	CA	72.0	72		F	11/02/2001	Pt received pneumonia vaccine on 11/01/2001. On 11/02/2001 arm hard, hot, painful, swollen and filled with fluid.									U	11/01/2001	11/02/2001	1		PUB	PVT						1						1	Injection site mass; Injection site pain; Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0177391	11/08/2001	CA	66.0	66		F	11/02/2001	Pt received pneumonia vaccine on 11/01/2001. On 11/02/2001 arm hard, hot, painful, swollen and filled with fluid.									U	11/01/2001	11/02/2001	1		PUB	PVT		NONE				1						1	Feeling hot; Oedema; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0177392	11/08/2001	KY	56.0	56		F	11/02/2001	1 inch by 3 inches warm raised area at injection site. Are is not sore or tender to touch. Area was noted 3 days after flu shot.									Y	10/31/2001	11/02/2001	2	NONE	PVT	UNK	Zoloft, Buspes	History of diabetes for 1.5 years	diabetes for 1.5 years		KY2001082	1						1	Injection site reaction	FLU3~SANOFI PASTEUR~UO676AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177393	11/08/2001	KY	30.0	30		F	11/02/2001	Left arm aches. Massaging feels good. Started after getting the vaccine. Pain from left shoulder to left hand.									Y	11/01/2001	11/02/2001	1	NONE	PVT	UNK	NONE	NONE	NONE		KY2001083	1						1	Injection site pain; Pain	FLU3~SANOFI PASTEUR~UO676AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177394	11/08/2001	PA	56.0	46		F	10/01/2001	Soreness and erythema at injection site started 10/18/2001 and developed into 8 by 5 erythema with induration. Erythema and soreness finally resolved by 10/24/2001-10/25/2001.									Y	10/17/1991				PVT	PVT	Restoril					1						1	Erythema; Pain	FLU3~SANOFI PASTEUR~UO593AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177395	11/08/2001	OK	51.0	51		F	11/01/2001	10/27/2001 Lethargy. 10/28/2001 and  10/29/2001 Emotional lability.									Y	10/26/2001	10/27/2001	1	NONE	OTH	OTH	Metferma XR, Alcutrol, Premarin, Foshpril, Zoloft, Simvastatin and Asprin.	NONE	DM2, Allergeis:Cephradine, cephalexia, ATN, Optic nerve diusen.			1						1	Affect lability; Lethargy	FLU3~SANOFI PASTEUR~UO670AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~474941~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0177396	11/08/2001	MO	60.0	60		F	11/06/2001	Reaction started  around 4 hrs after injection. Symptoms include dryness, edema, erythema of left deltoid arm. States seemed to be improving by the next day.									Y	11/05/2001	11/05/2001	0	NONE	PUB	PVT	Duratuss, Prilosec, Premarin		Allergy to sulfa and some antibiotics			1						1	Application site oedema; Dry skin; Erythema	FLU3~SANOFI PASTEUR~u0574AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1659L~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177420	11/08/2001	IL	66.0	66		F	11/01/2001	Localized allergic reaction 6-7 cm diameter of erythema and heat at injection site right deltoid. Treatment: ice, hold physical therapy, Medrol dose pack.										10/30/2001	10/31/2001	1		PVT	UNK		NONE	Pneumovax local reaction, macrodontin septra	local reaction~Pneumo (Pneumovax)~~0.00~In Patient		1						1	Feeling hot; Hypersensitivity; Injection site erythema; Injection site reaction	FLU3~SANOFI PASTEUR~UO590AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0161287	11/09/2001	OH	33.0	33		F	02/14/2001	It was reported that a female patient received a Fluzone SV '00-'01 vaccination on 10 Oct 2000. Reportedly that same day the patient complained of fatigue and muscle aches. These symptoms subsides one week later. From add. correspondence received on 7 Feb 2001, add. pt, responsible physician, vaccine administrator and the times of vaccination and adverse event onset were provided.									Y	10/10/2000	10/10/2000	0		PVT	PVT	Allegra, Flovent, Patanol, Proventil, HFA, Singular	NONE	Allergic rhinitis and conjunctivitis, asthma		U200100138	1						2	Asthenia; Myalgia	FLU3~AVENTIS PASTEUR~U0399BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0161290	11/09/2001	OH	73.0	73		F	02/14/2001	It was reported that a pt received a Fluzone SV 2000-2001 vaccination on 10/10/2000. Reportedly on 10/11/2000 the pt complained of itching and generalized rash. Further information is requested. From additional correspondence received on 02/07/2001 it was reported that the pts itching and rash subsided by 10/16/2000. The pt reportedly recovered from this experience.									Y	10/10/2000	10/11/2000	1	NONE	PVT	PVT	Toprol XL, Gamma Knife TXS, HCTZ	NONE	Asthma, HTN, Arthritis, Meningioma		U2001001400	1						2	Pruritus; Rash	FLU3~AVENTIS PASTEUR~U0399BA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0161740	11/09/2001	OH	71.0	71		M	02/14/2001	It was reported that a male pt received a Fluzone SV 2000-2001 vaccination IM on 10/10/2000. Reportedly on 10/12/2000 the pt complained of itching and generalized rash. Further information is requested. From additional correspondence received on 02/07/2001 it was reported that the pt was diagnosed with allergic dermatitis on 10/13/2000. Additional pt, responsible physician, vaccine administrator and the time of vaccination and adverse event onset time were also provided.									U	10/10/2000	10/12/2000	2	Assessed by physician on 10/13/2000	PVT	PVT	Lipitor, Lanoxin, Zestril, Hytrin, ASA, Claritin, Coreg	NONE	HTN, Hyperlipidemia, Heart Disease (LBBB), PCN Allergy		U2001001390	1						2	Dermatitis allergic; Pruritus; Rash	FLU3~AVENTIS PASTEUR~U0399BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0163568	11/09/2001	MS	50.0	50		F	01/25/2001	It was reported that a 50 year old female patient received a Fluzone SV vaccination on 11/28/2000.  Reportedly within 24 hours, the patient developed a reddened area from her chin to her inner thighs and from the base of the neck to the buttocks, like a sunburn, which is now peeling.									U	11/28/2000	11/29/2000	1		UNK	UNK					U200100226	1						2	Erythema; Skin exfoliation	FLU3~AVENTIS PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0163759	11/09/2001	TN	22.0	22		F	04/09/2001	Reportedly the patient developed a dermatitis skin reaction to the upper torso, back and both thighs. The patient noticed itching within 24 hours. These symptoms still persist.									Y	12/07/2000	12/08/2000	1	NONE	UNK	UNK		NONE	Aspirin allergy.		U200100229	1						2	Dermatitis; Pruritus	FLU3~AVENTIS PASTEUR~U0434AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0163832	11/09/2001	CA	19.0	19		M	02/22/2001	It was reported that a 19 year old male patient received a Fluzone SV vaccination on 11/25/2000. Reportedly that same day the patient complained of a pruritic macula rash and erythema on his trunk. On 11/26/2000 the patient developed a sore throat. On 11/27/2000 the patient developed myalgia and a fever. From additional correspondence received on 02/16/2001, additional lab data, patient, vaccine, adverse event onset, narrative and responsible physician information was provided. Narrative reads pruritic macular erythematous rash of BUE's/BLE's and trunk - onset 8 to 10 hours after the flu vaccine. One day after the vaccine the patient's throat was sore. Two days after the flu vaccine the patient had myalgia and a fever.				Y					N	11/25/2000	11/25/2000	0	Monospot = negative; strep throat screen = negative	PVT	UNK					U200100206	1						2	Myalgia; Pharyngolaryngeal pain; Pyrexia; Rash macular; Rash pruritic	FLU3~AVENTIS PASTEUR~U0398AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0163970	11/09/2001	MN	56.0	56		F	03/15/2001	About 1/2 hour after the vaccination, the patient developed pain across the middle of her back which still persists. The patient has no respiratory distress. From additional correspondence received on 03/13/2001, it was reported, 03/07/2001, reviewed and no additional information at this time.									N	12/13/2000	12/13/2000	0		UNK	UNK					U200100232	1						2	Back pain	FLU3~AVENTIS PASTEUR~U0440AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0164051	11/09/2001	PA	67.0	67		F	03/14/2001	The same day of the vaccination the patient developed a fever of 101.5F. Further information is requested. From additional information received on 12/14/2000, it was reported the patient was treated with Tylenol. No further information is expected. This case is closed.									Y	10/24/2000	10/24/2000	0		OTH	PVT	Oscal, Phenobarbital, Evista, Vitamin B12 and Dilantin.	NONE	Seizure disorder, anemia and osteoporosis.		U2001001560	1						2	Pyrexia	FLU3~AVENTIS PASTEUR~U0345AC~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0164195	11/09/2001	PA	50.0	50		F	02/15/2001	It was reported that a female pt received a Fluzone SV '00-'01 vaccination (IM) on 31 Oct 2000 at 11:00 AM. Reportedly on 1 Nov 2000 at 10:00 AM, the pt developed a local reaction of redness and swelling. The pt stated tp the reporter that she always had this type of reaction to vaccines.									Y	10/31/2000	11/01/2000	1		OTH	PVT	Calan, Premarin, Detrol, Proventil	NONE	Allergic: Novocaine, Iodine, sulfa, Asthma, Hypertension		U200100157	1						2	Injection site reaction	FLU3~AVENTIS PASTEUR~U0345AC~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0165269	11/09/2001	NC	68.0	68		M	02/22/2001	Post vax, the patient complained of generalized hives. The patient was treated with Benadryl and Claritin. The patient recovered in a few days.									Y	01/16/2001	01/16/2001	0		UNK	UNK					U200100300	1						2	Face oedema; Hypersensitivity; Oedema peripheral; Urticaria; Urticaria	FLU3~AVENTIS PASTEUR~U0465AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~AVENTIS PASTEUR~U0465AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0165469	11/09/2001	GA	36.0	36		F	03/14/2001	It was reported that the patient developed left arm pain from her shoulder to her fingers, general achiness, shooting pain and difficulty moving her arm persists. From additional correspondence received on 03/12/2001, additional patient, vaccine administrator and responsible facility information were provided.									U	11/27/2000			NONE	PUB	PVT	Reglan	NONE	Allergic to MS, Codeine, Sulfa and Cefzil.		U200100228	1						2	Arthralgia; Asthenia; Pain; Hypokinesia; Pain; Shoulder pain	FLU3~AVENTIS PASTEUR~U04355AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~AVENTIS PASTEUR~U04355AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0166392	11/09/2001	AZ	42.0	42		F	03/12/2001	About 8 hours after vaccination the pt developed itchy, hives below injection site. She was seen in  Dr's office next morning, at that time had tightness in chest and throat. given antihistamines and steroids and a breathing treatment, resolved in 6 weeks.				Y					Y	01/03/2001	01/03/2001	0		OTH	OTH	History of anaphylaxis after chemo treatment on 10/13/2000-takes Adriamycin for prevention of recurrence of breast cancer		History of breast cancer		U200100507	1						2	Chest discomfort; Dyspnoea; Urticaria; Chest discomfort; Pruritus; Throat tightness; Urticaria	FLU3~AVENTIS PASTEUR~U0446AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~AVENTIS PASTEUR~U0446AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0174945	11/09/2001	TX	65.0	65		F	06/07/2001	A nurse reported that pt had a reaction to vaccines within 24 hrs of administration. The pt developed redness and swelling. From mailed follow up received on 06/04/2001 it was stated, reviewed, no additional information at this time. Case is closed.									U	11/13/2000	11/14/2000	1	UNK	OTH	OTH		UNK	UNK		02001006200	1						2	Injection site erythema; Injection site oedema; Injection site erythema; Injection site swelling	FLU3~AVENTIS PASTEUR~U0410AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~469133~UNK~SC~~PNEUMO (PNU-IMUNE)~1|FLU3~AVENTIS PASTEUR~U0410AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~469133~UNK~SC~~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0174954	11/09/2001	TX	63.0	63		F	06/07/2001	A nurse reported that pt had a reaction within 24 hours of vaccinations. The pt developed vomiting, general myalagia and alternating feelings of hot and cold. She also developed an injection site reaction characterized by redness and swelling. From mailed follow up received on 06/04/01 it was stated, reviewed, no additional information at this time . This case is closed.									U	11/13/2000	11/14/2000	1	UNK	OTH	OTH		UNK	Multiple Sclerosis		02001006210	1						2	Feeling cold; Hot flush; Injection site erythema; Injection site swelling; Myalgia; Vomiting; Injection site erythema; Injection site swelling; Myalgia; Pyrexia; Vomiting	FLU3~AVENTIS PASTEUR~U0410AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~469133~UNK~IM~~PNEUMO (PNU-IMUNE)~1|FLU3~AVENTIS PASTEUR~U0410AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~PFIZER\WYETH~469133~UNK~SC~~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0177428	11/09/2001	PA	40.0	40		F	03/14/2001	It was reported that an adult female pt received a Fluzone SV '00-'01 vaccination (lot number not provided) on 20 Dec 2000. Reportedly within ten minutes of receiving vaccination the pt experienced a systemic reaction consisting of throat closing, face swelling and shortness of breath.									Y	12/20/2000	12/20/2000	0		PVT	UNK			Patient has had flu vaccine (manufacturer unknown)broke out in hives. Benadryl		U2001002500	1						1	Hypersensitivity	FLU3~AVENTIS PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177429	11/09/2001	PA				F	08/01/2000	It was reported that a female pt received a Fluzone unspecified vaccination sometime in 1998. reportedly the pt claims she has experienced left side weakness since 1998. No specifics provided. Further information requested.									U					UNK	UNK					02000005910	1						1	Hemiparesis	FLU3~CONNAUGHT LABORATORIES~0981810~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177430	11/09/2001	CT				F	08/10/2000	After receiving a vaccination, on 10/07/1999, the patient experienced persistent proximal shoulder and thigh pain similar to polymyalgia rheumatica. The patient was responsive to Prednisone greater than or equal to 10mg every day, but normal erythrocyte sedimentation rate 2 wks after the vaccination.				Y					N	09/22/1999	10/07/1999	15	Bone scan, x-ray, MRI, LABS all unremarkable.	PVT	OTH			NONE		02000006030	1						1	Pain; Polymyalgia rheumatica; Shoulder pain	FLU3~CONNAUGHT LABORATORIES~U0103AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177431	11/09/2001	CA	64.0			F	11/06/2000	It was reported that a 64 yr old female pt rec'd a flu vaccination on 11/15/99. Reportedly that same day the pt developed GI upset, cramps, diarrhea and weakness to the point of  feeling faint. Pt was treated with IV fluids at the hospital and released. Gastroenterologist evaluated pt. Sigmoidoscopy was normal with small hemorrhoidal bleeding. Pt was informed by hospital staff these reactions were not related to the flu vaccine.				Y					U	11/15/1999	11/15/1999	0	Sigmoidoscopy normal with small hemorrhoidal bleeding.	OTH	OTH					U2000007940	1						1	Abdominal discomfort; Abdominal pain; Asthenia; Diarrhoea; Haemorrhoids; Syncope	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177432	11/09/2001	NV	46.0	46		F	11/22/2000	It was reported that a 46 year old female pt received a Fluzone SV '00-'01 vaccination on 9/22/00 at 08:00 as well as having blood drawn in the same arm. The pt contacted the Center to say that her hand was swelling and the injection site was sore. The pt was referred to her physician. Reportedly, the pt recovered from this experience. Received correspondence on 2/1/01 stating nothing more to add.				Y					Y	09/22/2000	09/22/2000	0	NONE	PUB	OTH		NONE	UNK		U2000008480	1						1	Injection site pain; Oedema peripheral	FLU3~AVENTIS PASTEUR~U0336CA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177433	11/09/2001					U	01/17/2001	It was reported that a pt (1 of 5) received a Fluzone SV '00-'01 vaccination. Reportedly, sometime after the vaccination, the pt developed a local reaction of redness and warmth. No specifics provided, further information is requested.									U					OTH	OTH					U2001000790	1						1	Injection site erythema; Injection site warmth	FLU3~AVENTIS PASTEUR~U0335AB~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177434	11/09/2001					U	01/17/2001	It was reported that a pt (2 of 5) received a Fluzone SV '00-'01 vaccination. Reportedly sometime after the vaccination the pt developed a local reaction of redness and warmth. No specifics provided, further information is requested.														UNK	UNK					U200100080	1						1	Erythema	FLU3~AVENTIS PASTEUR~UO335AB~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177435	11/09/2001					U	01/17/2001	It was reported that a pt (3 of 5) received a Fluzone SV 'oo - 01 vaccination. Reportedly sometime after the vaccination the pt developed a local reaction of redness and warmth. No specifics provided, further information is requested.														UNK	UNK					U200100081	1						1	Vasodilation procedure	FLU3~AVENTIS PASTEUR~U0335AB~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177436	11/09/2001					U	01/17/2001	It was reported that a pt (4 of 5) received a Fluzone SV '00 - '0 vaccination. Reportedly sometime after the vaccination the pt developed a local reaction of redness and warmth. No specifics provided, further information is requested.														UNK	UNK					U200100082	1						1	Injection site reaction	FLU3~SANOFI PASTEUR~U0335AB~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177437	11/09/2001					U	01/17/2001	It was reported that a pt (5 of 5) received a Fluzone SV '00 - '0 vaccination. Reportedly sometime after the vaccination the pt developed a local reaction of redness and warmth. No specifics provided, further information is requested.														UNK	UNK					U200100083	1						1	Injection site erythema; Injection site warmth	FLU3~AVENTIS PASTEUR~U0335AB~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177438	11/09/2001	CA				U	01/17/2001	It was reported that a pt (1 of 10) received a Fluzone SV '00-'01 on 9 Oct 2000. Reportedly within 48-72 hours post vaccination the pt complained of pain, redness, swelling and induration at the injection site. No specific provided, further information requested.									U	10/09/2000				UNK	UNK					U200100084	1						1	Injection site mass; Injection site oedema; Pain; Vasodilation procedure	FLU3~AVENTIS PASTEUR~U0403AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177439	11/09/2001	CA				U	01/17/2001	It was reported that a pt (2 of 10) received a Fluzone SV '00-'01 on 10/9/00. Reportedly, within 48-72 hours, post vax, the pt complained of pain, redness, swelling and induration at the injection site. No specifics provided; further information requested.									U	10/09/2000				UNK	UNK					U2001000850	1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling	FLU3~AVENTIS PASTEUR~U0403AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177440	11/09/2001	CA				U	01/17/2001	It was reported that a pt (3 of 10) received a Fluzone SV '00-'01 on 10/9/00. Reportedly, within 48-72 hours, post vax, the pt complained of pain, redness, swelling and induration at the injection site. No specifics provided, further information requested.									U	10/09/2000				OTH	OTH					U2001000860	1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling	FLU3~AVENTIS PASTEUR~U0403AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177441	11/09/2001	CA				U	01/17/2001	It was reported that a pt (4 of 10) received a Fluzone SV '00-'01 on 10/9/00. Reportedly, within 48-72 hours, post vax, the pt complained of pain, redness, swelling and induration at the injection site. No specifics provided; further information requested.									U	10/09/2000				OTH	OTH					U2001000870	1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling	FLU3~AVENTIS PASTEUR~U0403AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177442	11/09/2001	CA				U	01/17/2001	It was reported that a pt (5 of 10) received a Fluzone SV '00-'01 on 10/9/00. Reportedly, within 48-72 hours, post vax, the pt complained of pain, redness, swelling and induration at the injection site. No specifics provided; further information requested.									U	10/09/2000				OTH	OTH					U2001000880	1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling	FLU3~AVENTIS PASTEUR~U0403AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177443	11/09/2001	CA				U	01/17/2001	It was reported that a pt (6 of 10) received a Fluzone SV '00-'01 on 10/9/00. Reportedly, within 48-72 hours, post vax, the pt complained of pain, redness, swelling and induration at the injection site. No specifics provided; further information requested.									U	10/09/2000				OTH	OTH					U2001000890	1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling	FLU3~AVENTIS PASTEUR~U0403AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177444	11/09/2001	CA				U	01/17/2001	It was reported that a pt (7 of 10) received a Fluzone SV '00-'01 on 10/9/00. Reportedly, within 48-72 hours, post vax, the pt complained of pain, redness, swelling and induration at the injection site. No specifics provided; further information requested.									U	10/09/2000				OTH	OTH					U2001000900	1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling	FLU3~AVENTIS PASTEUR~U0403AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177445	11/09/2001	CA				U	01/17/2001	It was reported that a pt (8 of 10) received a Fluzone SV '00-'01 on 9 Oct 2000. Reportedly within 48 - 72 hours post vaccination the pt complained of pain, redness, swelling and induration at the injection site. No specific provided, further information requested.									U	10/09/2000			Injection site reaction.	UNK	UNK					U200100091	1						1	Injection site reaction	FLU3~AVENTIS PASTEUR~U0403AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177446	11/09/2001	CA				U	01/17/2001	It was reported that a pt (9 of 10) received a Fluzone SV '00-'01 on 9 Oct 2000. Reportedly within 48-72 hours post vaccination the pt complained of pain, redness, swelling and induration at the injection site. No specifics provided, further information requested.									U	10/09/2000				UNK	UNK					U200100092	1						1	Injection site erythema; Injection site oedema; Injection site reaction; Pain	FLU3~AVENTIS PASTEUR~U0403AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177447	11/09/2001	CA				U	01/17/2001	It was reported that a pt (10 of 10) received a Fluzone SV '00-'01 on 9 Oct 2000. Reportedly within 48-72 hours post vaccination the pt complained of pain, redness, swelling and induration at the injection site. No specifics provided, further information requested.									U	10/09/2000				UNK	UNK					U2001000930	1						1	Injection site mass; Injection site oedema; Pain	FLU3~AVENTIS PASTEUR~U0403AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177448	11/09/2001	MO	34.0	34		F	03/14/2001	It was reported that a female pt received a Fluzone SV '00-'01 vaccination in the gluteal area on 11 Oct 2000. Reportedly 12 Oct 2000 the pt developed a local reaction of redness and swelling. Further information requested. Pt received the Flu-vaccine in the hip.									Y	10/11/2000	10/12/2000	1		UNK	UNK	Humulin, insulin slide scale		IDDM		U2001000940	1						1	Injection site erythema; Injection site oedema	FLU3~AVENTIS PASTEUR~U0399EA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177449	11/09/2001	ID	51.0	51		M	02/14/2001	It was reported that a 51-year old male patient received a Fluzone SV '00-'01 vaccination on 16 Oct 2000 at 10 am. At 2 pm the patient developed pain in arm, extremities and pelvic area along with fatigue. At 6 pm the pt developed shaking, chills, malaise and was achy. Pt slept from 9pm to morning the symptoms were gone. The pt recovered from the experience. No additional information was provided from correspondence received on 7 Feb 2001. No further information is expected. This case is closed.									Y	10/16/2000	10/16/2000	0		OTH	OTH		pain, asthenia, chills, malaise.	NONE		U200100099	1						1	Chills; Injection site pain; Malaise; Myalgia; Tremor	FLU3~AVENTIS PASTEUR~U0399AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177450	11/09/2001	TN				U	01/18/2001	It was reported that a pt (1 of 13) received a Fluzone SV '00-'01 vaccination on  17Oct2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested.									U	10/17/2000				UNK	UNK					U200100101	1						1	Injection site reaction	FLU3~AVENTIS PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177451	11/09/2001	TN				U	01/18/2001	It was reported that a pt (2 of 13) received a Fluzone SV '00-'01 vaccination on 17Oct2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested.									U	10/17/2000				UNK	UNK					U200100102	1						1	Injection site reaction	FLU3~AVENTIS PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177452	11/09/2001	TN				U	01/18/2001	It was reported that a pt (3 of 13) received a Fluzone SV '01-'02 vaccination on 10/17/00. Reportedly, sometime after the vaccination, the pt developed a local reaction. No specifics were provided. Further information is requested.									U	10/17/2000				UNK	UNK					U200100103	1						1	Injection site reaction	FLU3~AVENTIS PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177453	11/09/2001	TN				U	01/18/2001	It was reported that a pt (4 of 13) received a Fluzone SV '00-'01 vaccination on 17 Oct 2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested.									U	10/17/2000			Injection site reaction.	UNK	UNK					U200100104	1						1	Injection site reaction	FLU3~AVENTIS PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177454	11/09/2001	TN				U	01/18/2001	It was reported that a pt (5 of 13) received a Fluzone SV '00-'01 vaccination on 17 Oct 2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested.									U	10/17/2000				UNK	UNK					U200100105	1						1	Injection site reaction	FLU3~AVENTIS PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177455	11/09/2001	TN				U	01/18/2001	It was reported that a pt (6 of 13) received a Fluzone SV '00-'01 vaccination on 17 Oct 2000. reportedly sometime after the vaccination the pt develope a local reaction. No specifics were provided. Further information is requested.									U	10/17/2000				UNK	UNK					U200100106	1						1	Injection site reaction	FLU3~AVENTIS PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177456	11/09/2001	TN				U	01/18/2001	It was reported that a pt (7 of 13) received a Fluzone SV '00-'01 vaccination on 17 Oct 2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested.									U	10/17/2000				UNK	UNK					U200100107	1						1	Injection site reaction	FLU3~AVENTIS PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177457	11/09/2001					U	01/18/2001	It was reported that a pt (8 of 13) received a Fluzone SV '00-'01 vaccination on 17 Oct 2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested.l									U	10/17/2000				UNK	UNK					U200100108	1						1	Injection site reaction	FLU3~AVENTIS PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177458	11/09/2001	TN				U	01/18/2001	It was reported that a pt (9 of 13) received a Fluzone SV 2000-2001 vaccination on 10/17/2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested.									U	10/17/2000				OTH	OTH					U2001001090	1						1	Injection site reaction	FLU3~AVENTIS PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177459	11/09/2001	TN				U	01/18/2001	It was reported that a pt (10 of 13) received a Fluzone SV '00-'01 vaccination on 17 Oct 2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested.									U	10/17/2000				UNK	UNK					U2001001100	1						1	Injection site reaction	FLU3~AVENTIS PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177460	11/09/2001	TN				U	01/18/2001	It was reported that a pt (11 of 13) received a Fluzone SV '00-'01 vaccination on 17 Oct 2000. Reportedly sometime after the vaccination the patient developed a local reaction. No specifics were provided. Further information is requested.									U	10/17/2000				UNK	UNK					U200100111	1						1	Injection site reaction	FLU3~AVENTIS PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177461	11/09/2001	TN				U	01/18/2001	It was reported that a patient (12 of 13) received a Fluzone SV '00-'01 vaccination on 17 Oct 2000. Reportedly sometime after the vaccination the patient developed a local reaction. No specifics were provided. Further information is requested.									U	10/17/2000				UNK	UNK					U200100112	1						1	Injection site reaction	FLU3~AVENTIS PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177462	11/09/2001	TN				U	01/18/2001	It was reported that a pt (13 of 13) received a Fluzone SV 2000-2001 vaccination on 10/17/2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested.									U	10/17/2000				OTH	OTH					U2001001130	1						1	Injection site reaction	FLU3~AVENTIS PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177463	11/09/2001	CA	30.0			F	01/18/2001	It was reported that a 30 year old woman was vaccinated with a Fluzone SV '00-'01 vaccination on 13 Oct 2000. Reportedly the same day the patient experienced local pain, burning, and a red, itching rash from the shoulder to elbow. On 17 Oct 2000, the pt was starting to improve. Further info is being requested. From add. info received 01 Feb 2001, pt has recovered.									Y	10/13/2000	10/13/2000	0		PVT	PVT					U200100115	1						1	Hypersensitivity; Pain; Pruritus; Rash	FLU3~AVENTIS PASTEUR~U0402BA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177464	11/09/2001	CA	45.0			F	02/12/2001	It was reported that a pt received Fluzone SV 2000-2001 vaccination on 10/13/2000. Reportedly on 10/14/2000 the pt experienced itching, rash and pain at the injection site. She also experienced internal itching in abdomen and a stomach ache which lasted for three days. Further information is being requested. From additional correspondence received on 02/01/2001, it was reported that the pt recovered from this experience.									Y	10/13/2000	10/14/2000	1		PVT	PVT					U2001001210	1						1	Abdominal pain; Pain; Pruritus	FLU3~AVENTIS PASTEUR~U0402BA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177465	11/09/2001	FL				F	03/20/2001	It was reported that a pt (1 of 4) received a Fluzone 2000-2001 vaccination, given IM on 10/19/2000. Reportedly the pt developed numbness and tingling in the arm and hand after the injection. No specifics were provided. Further information is being requested. From additional correspondence received on 03/16/2001, it was reported, mild, short duration relived with ice application.  Reportedly the pt recovered from this experience.									Y	10/19/2000	10/19/2000	0		OTH	OTH					U2001001240	1						1	Hypoaesthesia; Paraesthesia	FLU3~AVENTIS PASTEUR~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177466	11/09/2001	FL				F	03/20/2001	It was reported that a pt (2 of 4) received a Fluzone 2000-2001 vaccination, given IM on 10/19/2000. Reportedly the pt developed numbness and tingling in the arm and hand after the injection. No specifics were provided. Further information is being requested. From additional correspondence received on 03/16/2001 it was reported, given follow-up by employer and is discharged from further intervention. Reportedly the pt recovered from this experience no residue.				Y					Y	10/19/2000	10/19/2000	0		OTH	OTH					U2001001260	1						1	Hypoaesthesia; Paraesthesia	FLU3~AVENTIS PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177467	11/09/2001	FL				F	03/20/2001	It was reported that a pt (3 of 4) received a Fluzone 2000-2001 vaccination, given IM on 10/19/2000. Reportedly the pt developed numbness and tingling in the arm and hand after the injection. No specifics were provided. Further information is being requested. From additional correspondence received on 03/16/2001, it was reported mild relieved with ice packs. The pt reportedly recovered from this experience. Additional responsible facility, vaccine and pt information was provided.									Y	10/19/2000	10/19/2000	0		OTH	OTH					U2001001270	1						1	Hypoaesthesia; Paraesthesia	FLU3~AVENTIS PASTEUR~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177468	11/09/2001	FL				F	03/20/2001	It was reported that a patient (4 of 4) received a Fluzone '00-'01 vaccination, given IM on 19 Oct 2000. Reportedly the patient developed numbness and tingling in the arm and hand after the injection. No specifics were provided. Further information is being requested. For additional correspondence received on 16 March 2001, it was reported, mild relieved with ice packs. The pt reportedly recovered from this experience. Additional responsible facility, vaccine, and pt information was provided.									Y	10/19/2000	10/19/2000	0		OTH	OTH					U200100128	1						1	Paraesthesia	FLU3~AVENTIS PASTEUR~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177469	11/09/2001	FL	55.0	55		F	02/12/2001	It was reported that a female pt received a Fluzone SV 2000-2001 vaccination on 10/23/2000. Reportedly that same day the pt experienced hives and itching which were treated with antihistamines. The experience is resolving. Further information is being requested. From additional correspondence received on 02/02/2001, it was reported that the pt recovered from this experience. Additional vaccine pt and reporter information was also provided.									Y	10/23/2000	10/23/2000	0		PUB	PUB			Phenolpthelin		U2001001320	1						1	Pruritus; Urticaria	FLU3~AVENTIS PASTEUR~O0408DA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177470	11/09/2001	PA	46.0	46		F	02/14/2001	It was reported that a pt received a Fluzone SV 2000-2001 vaccination on 10/23/2000. Reportedly that same day the pt experienced redness and swelling at the injection site, dizziness, nausea and fainting. She was sent to the ER. No specifics were provided. Further information is being requested. From additional correspondence received on 02/07/2001 additional pt, vaccine administrator and responsible physician information was provided. No further information is expected for this case. Case is closed.				Y					U	10/23/2000	10/23/2000	0		PVT	PVT		NONE	Hypothyroidism, DTD, HTN, Lupus		U2001001360	1						1	Dizziness; Injection site reaction; Nausea; Oedema; Syncope	FLU3~AVENTIS PASTEUR~U04158A~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177471	11/09/2001	PA	41.0	40		F	02/14/2001	Edema Nausea Dizziness Sweating Injection Site Reaction It was reported that a 41-year-old woman received a Fluzone SV '00-'01 vaccination on 23-Oct-2000. Reportedly, fifteen minutes after the vaccination the patient experienced redness and swelling at the injection site, dizziness, nausea and cool and clammy skin. The patient laid down for twenty minutes and the symptoms subsided. Further information is being requested. From additional correspondence received on 7-Feb-2001, it was reported that the patient recovered from this experience. Additional patient, vaccine administrator and responsible physician information was also provided. No further information is expected for this case. Case is closed.									Y	10/23/2000	10/23/2000	0		PVT	UNK		None	Hypercholestemia, Renal Calculi, Seizure disorder,Migraine Ha			1						1	Dizziness; Hyperhidrosis; Injection site reaction; Nausea; Oedema	FLU3~AVENTIS PASTEUR~U04158A~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177475	11/09/2001	MI	15.0	15		M	01/18/2001	It was reported that a pt received a Fluzone SV 2000-2001 vaccination on 10/26/2000. Reportedly the pt developed a local reaction within 24 hours of vaccination consisting of injection site warmth, redness and bruise. Further information is requested.									U	10/26/2000	10/27/2000	1		OTH	OTH					U2001001430	1						1	Injection site reaction	FLU3~AVENTIS PASTEUR~U0410AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177476	11/09/2001	SC				M	01/18/2001	It was reported that a male pt received a Fluzone SV '00-'01 vaccination on 30 Oct 2000. Reportedly the pt developed urticaria 4 hours after injection and was managed with Benadryl. Further information is requested.									U	10/30/2000	10/30/2000	0		UNK	UNK					02001001490	1						1	Urticaria	FLU3~AVENTIS PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177477	11/09/2001	ID	37.0	37		F	02/14/2001	It was reported that a pt received a Fluzone SV 2000-2001 vaccination on 10/31/2000. Reportedly 24 hours after injection the pt developed a local reaction. Four days later developed itching at injection site. Further information is requested. From additional correspondence received on 02/07/2001, it was reported that the pt recovered from this experience. Additional pt, vaccine administrator and responsible physician information was also provided.									Y	10/31/2000	11/01/2000	1	NONE	PVT	PVT		Erythema left deltoid	NONE		U2001001500	1						1	Injection site hypersensitivity; Pruritus	FLU3~AVENTIS PASTEUR~U0409AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177478	11/09/2001	OK	66.0	66		M	02/16/2001	It was reported that a male pt received a Fluzone SV '00-'01 vaccination 25 Oct 2000. Reportedly that same day the patient complained of soreness and numbness with elevation of arm at injection site. Further information is requested.									U	10/25/2000	10/25/2000	0		PVT	PVT					U200100151	1						1	Injection site pain	FLU3~AVENTIS PASTEUR~U0415AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177479	11/09/2001	IL				U	01/18/2001	It  was reported that a patient (1 of 2) received a Fluzone SV '00-'01 vaccination. Sometime after the injection the patient complained of induration, swelling and redness and injection site. Further information is requested.														UNK	UNK					02001001520	1						1	Injection site reaction	FLU3~AVENTIS PASTEUR~U0337AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~0710K~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0177480	11/09/2001	IL				U	01/18/2001	It was reported that a patient (2 of 2) received a Fluzone SV '00-'01 vaccination. Sometime after the injection the patient complained of induration, swelling and redness and injection site. Further information is requested.									U					UNK	UNK					02001001530	1						1	Injection site reaction	FLU3~AVENTIS PASTEUR~U0337AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0710K~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177481	11/09/2001	UT	38.0	38		F	03/14/2001	It was reported that a female patient received a Fluzone SV'00-'01 vaccination on 6 Nov 2000. Approximately 5 hours after vaccination the patient developed ulcers in her mouth and swelling of her tongue, no respiratory distress and pain in her jaw. Further information is requested. From additional correspondence received on 8 Mar 2001, it was reported that the pt experienced pain when attempting to open her mouth. The pt reportedly recovered from this experience with no sequelae. Add. pt, lab data and responsible physician information were also provided.				Y					Y	11/06/2000	11/06/2000	0		PVT	PVT		NONE	Medicine allergies		U200100154	1						1	Mouth ulceration; Tongue oedema	FLU3~AVENTIS PASTEUR~U0398AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177482	11/09/2001	IL		48		F	01/18/2001	It was reported that a female patient received a Fluzone SV '00-'01 vaccination on 28 Oct 2000. Reportedly the pt developed pain the same evening as dose was administered and described as grabbing pain. Turned into severe pain to where she was incapacitated. Soreness in chest from back spasms. Hurts to take a breath. Residual ache and back soreness on left, which was vaccine, site. Pt has had fibromyalgia for 15 yrs and this is not that kind of pain.				Y						10/28/2000	10/28/2000	0		UNK	UNK	Naprosyn, Medrolpack				U200100155	1						1	Muscle spasms; Pain	FLU3~AVENTIS PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177485	11/09/2001	PA	31.0	31		F	01/19/2001	One day post vax, pt complained of redness approximately 1 3/4, swelling, itching and pain at site of injection. On 11/9/00, the swelling decreased but the redness increased approximately .5. The pt complained of headache, increase of itching and pain. Further info is requested.									U	11/06/2000	11/07/2000	1		OTH	OTH					U2001001580	1						1	Headache; Injection site erythema; Injection site pain; Injection site swelling; Pruritus	FLU3~AVENTIS PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177486	11/09/2001	PA		52		F	01/20/2001	Sometime post vax (date not specified) pt complained of redness and swelling at the site of injection. Further info is requested.									U	10/01/2000				OTH	OTH					U2001001590	1						1	Injection site erythema; Injection site swelling	FLU3~AVENTIS PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177487	11/09/2001	MA	71.0	71		F	02/15/2001	Pt developed a large local reaction immediately post vax. No specifics were provided. From further correspondence recvd 2/8/01. it was reported that the pt has not recovered from this experience. Further info is requested.									N	11/08/2000	11/08/2000	0		PUB	OTH		NONE			U2001001650	1						1	Injection site reaction; Injection site hypersensitivity; Injection site oedema; Injection site pain; Injection site warmth	FLU3~AVENTIS PASTEUR~U0403AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~AVENTIS PASTEUR~U0403AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0177487	11/09/2001	MA	71.0	71		F	01/25/2001	It was reported that a 71 year old female patient received a Fluzone SV vaccination on 11/8/2000. Reportedly the patient's arm immediately hurt and became red. The vaccination was given down in the middle of the arm instead of the deltoid. The patient was advised to treat with ice. The next day the patient went to see her physician who also stated the injection was placed too low and put the patient on Benadryl for 2 days. This took the heat, swelling, redness and pain away.				Y					Y	11/08/2000	11/08/2000	0		UNK	UNK					U200100223	1						2	Injection site reaction; Injection site hypersensitivity; Injection site oedema; Injection site pain; Injection site warmth	FLU3~AVENTIS PASTEUR~U0403AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~AVENTIS PASTEUR~U0403AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0177488	11/09/2001	MA	19.0	19		F	03/09/2001	On 11/12/00, pt developed paresthesia of the right arm and leg. Pt was evaluated at college facility. MD felt symptoms were self-eliminating. Addtl info recvd 2/23/01 reported that the pt recovered from this experience. No further info is anticipated. This case is closed.				Y					Y	11/09/2000	11/12/2000	3		OTH	OTH		NONE	NONE		U2001001660	1						1	Paraesthesia	FLU3~AVENTIS PASTEUR~U0417AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177489	11/09/2001	CA	55.0	55		M	01/20/2001	It was reported that a male patient received a Fluzone SV vaccination on 10/23/2000. Reportedly 2 days after the injection, the patient developed a persistent tingling sensation from the injection site to his fingers. Further information is requested.									U	10/23/2000	10/25/2000	2		UNK	UNK					U200100167	1						1	Paraesthesia	FLU3~AVENTIS PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177490	11/09/2001	WI	27.0	26		M	01/20/2001	It was reported that a 27 year old male patient received a Fluzone SV vaccination on 11/14/2000. Reportedly that same day the patient complained of severe pain in the area of an hiatal hernia. Further information is requested.									U	11/14/2000	11/14/2000	0		UNK	UNK			Hiatal hernia		U200100168	1						1	Pain	FLU3~AVENTIS PASTEUR~U0422BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177491	11/09/2001	IA	82.0	82		F	02/12/2001	It was reported that an 82 year old female patient received a Fluzone SV vaccination on 11/14/2000. Reportedly later that day the patient's face and tongue were swollen, no respiratory distress. Further information is requested. From correspondence received on 02/02/2001 it was reported that the patient recovered from this experience. Additional patient, vaccine and the responsible physician and vaccine administator information were also provided.				Y					Y	11/14/2000	11/14/2000	0		PUB	PVT		NONE			U200101690	1						1	Face oedema; Tongue oedema	FLU3~AVENTIS PASTEUR~U0402EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177492	11/09/2001	PA	47.0	47		F	01/21/2001	It was reported that a 47 year old female patient received a Fluzone SV vaccination on 11/15/2000. Reportedly on 11/16/2000, the patient complained of redness, swelling, itching and warmth at the site of injection. The vaccine was administered in the upper arm, below the deltoid.									U	11/15/2000	11/16/2000	1		UNK	UNK					U200100170	1						1	Injection site hypersensitivity; Injection site oedema; Injection site warmth; Pruritus	FLU3~AVENTIS PASTEUR~U0345AC~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177493	11/09/2001	NC	52.0	52		F	01/21/2001	It was reported that a 52 year old female patient received a Fluzone SV vaccination on 11/15/2000. Reportedly 3-4 hours after the injection the patient developed a feeling in her throat (type of feeling not specified) and difficulty swallowing. There was no respiratory distress. These symptoms completely subsided in 12 hours.									Y	11/15/2000	11/15/2000	0		UNK	UNK					U200100171	1						1	Dysphagia; Laryngospasm	FLU3~AVENTIS PASTEUR~U0428AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177494	11/09/2001	MO	51.0	51		F	01/21/2001	It was reported that a 51 year old female patient received a Fluzone SV vaccination on 10/13/2000 at a hospital clinic. The patient developed hives with itching at the waist on 10/15/2000. The hives spread over her entire body. The patient went to the ER and was treated with Prednisone four times. The hives are now gone but the patient is still experiencing itching on her hands, feet and inner elbow areas.				Y					U	10/13/2000	10/15/2000	2		UNK	UNK			Mastectomy 4.5 years ago.		U200100172	1						1	Pruritus; Urticaria	FLU3~AVENTIS PASTEUR~U0405AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177495	11/09/2001	OH	59.0	59		F	01/21/2001	It was reported that a female patient received a Fluzone SV vaccination on 11/10/2000. Reportedly within the next day or two the patient developed swollen lymph glands under her arms. Further information is requested.									U	11/10/2000	11/11/2000	1		UNK	UNK					U200100173	1						1	Lymphadenopathy	FLU3~AVENTIS PASTEUR~U0423AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177496	11/09/2001	WI	48.0	48		F	03/08/2001	It was reported that a 48 year old female received a Fluzone SV vaccination on 11/07/2000. Approximately 2 weeks after the injection, the patient developed brachial plexus neuropathy, painful with movement. Further information is requested. From additional correspondence received on 02/21/2001, it was reported that the patient recovered from this experience. Additional patient, vaccine administrator and responsible physician information was also provided.									Y	11/07/2000	11/21/2000	14	NONE	UNK	UNK		NONE	NONE		U200100174	1						1	Neuropathy; Pain	FLU3~AVENTIS PASTEUR~U0403AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177497	11/09/2001	NJ	48.0	48		F	03/09/2001	It was reported that a female patient received a Fluzone SV vaccination on 11/10/2000. Within 18 hours of vaccination the patient developed Bell's Palsy to the left side of her face. The patient was treated in the ER and released. From additional correspondence received on 02/22/2001, it was reported that the patient recovered from this experience. Additional patient, vaccine administrator and responsible physician information were also provided. No further information is anticipated. This case is closed.				Y					Y	11/10/2000	11/11/2000	1		PVT	OTH					U200100178	1						1	Facial palsy	FLU3~AVENTIS PASTEUR~U0345AC~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177498	11/09/2001	CA	38.0			F	01/21/2001	It was reported that a female patient received a Fluzone SV vaccination on 11/20/2000. Approximately 24 hours after the vaccination, the patient developed a red area at the injection site.									U	11/20/2000	11/21/2000	1		UNK	UNK					U200100179	1						1	Injection site hypersensitivity	FLU3~AVENTIS PASTEUR~U0414BB~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177499	11/09/2001	PA	68.0	68		M	03/10/2001	It was reported that a male patient in his 40's received a Fluzone SV vaccination on 11/15/2000. Reportedly within 24 hours, the patient had flu-like symptoms and fever blisters on his lip and the septum of his nose. The symptoms resolved in a few days. From additional correspondence received on 02/28/2001, additional patient, vaccine administrator and responsible physician information were provided. No further information is anticipated. This case is closed.									Y	11/15/2000	11/17/2000	2		PVT	UNK		NONE			U200100182	1						1	Herpes simplex; Influenza	FLU3~AVENTIS PASTEUR~U0334AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177500	11/09/2001	OH	55.0	55		F	01/22/2001	It was reported that a 55 year old female patient received a Fluzone SV vaccination on 11/28/2000. Reportedly that same day, the patient complained of a rash on her neck and torso. Further information is requested.									U	11/28/2000	11/28/2000	0		UNK	UNK					U200100183	1						1	Rash	FLU3~AVENTIS PASTEUR~U0434AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177501	11/09/2001	FL				F	03/15/2001	It was reported that a patient (1 of 4) received a Fluzone SV vaccination on 11/30/2000. Reportedly the patient developed local redness within 1 hour of the injection. No specifics were provided. Further information is requested. From additional correspondence received 03/13/2001, it was reported that the patient recovered from this experience. Additional patient, vaccine, correct adverse event onset dates, vaccine administrator and responsible physician information were also provided.									Y	11/30/2000	11/30/2000	0		PVT	PVT		NONE	NONE		U200100184	1						1	Injection site hypersensitivity	FLU3~AVENTIS PASTEUR~U0435AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177502	11/09/2001	FL				U	03/15/2001	It was reported that a patient (2 of 4) received a Fluzone SV vaccination on 11/28/2000. Reportedly the patient developed local redness within 1 hour of the injection. No specifics were provided. Further information is requested. No further information was provided from correspondence returned on 03/13/2001.									U	11/28/2000	11/28/2000	0		UNK	UNK					U200100185	1						1	Injection site hypersensitivity	FLU3~AVENTIS PASTEUR~U0435AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177503	11/09/2001	FL	34.0	34		F	03/15/2001	It was reported that a patient (3 of 4) received a Fluzone SV vaccination on 11/28/2000. Reportedly the patient developed local redness within 1 hour of the injection. No specifics were provided. Further information is requested. From additional correspondence received 03/13/2001, it was reported that 48 hours post vaccine the patient experienced swelling and itching that progressed down her left arm past her elbow. Reportedly the patient recovered from this experience. Additional patient, vaccine, correct adverse event onset dates, vaccine administrator and responsible physician information were also provided.									Y	11/28/2000	11/30/2000	2		PVT	PVT		NONE	UNK		U200100186	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~AVENTIS PASTEUR~U0435AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177504	11/09/2001	FL	51.0	51		F	03/15/2001	It was reported that a patient (4 of 4) received a Fluzone SV vaccination on 12/01/2000. Reportedly the patient developed local redness within 1 hour of the injection. No specifics were provided. Further information is requested. From additional correspondence received 03/13/2001, it was reported that the patient awoke from sleep 12/01/2000 with pain, hardness and a 3cm burgundy colored area at the injection site. The patient was treated with Tylenol and Benadryl. The symptoms were resolved within 24 hours. Additional patient, vaccine, vaccine administrator and responsible physician information were also provided.									Y	12/01/2000	12/01/2000	0		PVT	PVT	Premarin	NONE	Allergic to morphine sulfate.		U200100187	1						1	Injection site hypersensitivity; Injection site induration; Injection site pain; Injection site hypersensitivity; Injection site induration; Injection site pain	FLU3~AVENTIS PASTEUR~U0435AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~AVENTIS PASTEUR~U0435AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0177504	11/09/2001	FL	51.0	51		F	03/08/2001	It was reported that a 51 year old female patient received a Fluzone SV vaccination on 12/01/2000 in the left deltoid. Reported the patient awoke from sleep later that evening with pain, hardness and a burgundy colored 3cm area at the site of injection. The patient was treated with Tylenol and Benadryl. These symptoms were resolved within 24 hours. From additional correspondence received on 02/21/2001, it was reported, reviewed, no additional information at this time. This case is closed.									Y	12/01/2000	12/01/2000	0		PVT	PVT	Premarin	NONE	Morphine Sulfate		U200100221	1						2	Injection site hypersensitivity; Injection site induration; Injection site pain; Injection site hypersensitivity; Injection site induration; Injection site pain	FLU3~AVENTIS PASTEUR~U0435AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~AVENTIS PASTEUR~U0435AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0177505	11/09/2001	MA	45.0			F	01/22/2001	It was reported that a 45 year old female patient received a Fluzone SV vaccination on 11/29/2000. Approximately one hour after vaccination the patient became wheezy, developed a fever of 102F, muscle aches and chills. Further information is requested.									U	11/29/2000	11/29/2000	0		UNK	UNK					U200100188	1						1	Asthma; Chills; Myalgia; Pyrexia	FLU3~AVENTIS PASTEUR~U0443AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177506	11/09/2001	IL				F	03/12/2001	It was reported that a female patient received a Fluzone SV on 11/29/2000. Reportedly on 12/01/2000, the patient complained of redness and pain at the injection site. The vaccination was received in the flu clinic at Walgreens. From additional correspondence received on 03/06/2001, the vaccine administrator and the address of the responsible facility were provided.									U	11/29/2000	12/01/2000	2		UNK	UNK					U200100200	1						1	Injection site hypersensitivity	FLU3~AVENTIS PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177508	11/09/2001	LA	54.0	54		F	02/28/2001	It was reported that a female pt received a Fluzone SV '00-'01 vaccination on 1/21/01. Reportedly, on 1/25/01, the pt was admitted to the hospital with flu-like symptoms. The physician does not yet know if it is a side effect of the vaccine or the actual flu. Further information requested. From additional correspondence received on 2/20/01, the responsible physician and vaccine administrator information was provided.					Y				U	01/21/2001	01/25/2001	4		PVT	OTH					U2001002340	1						1	Influenza like illness	FLU3~AVENTIS PASTEUR~U0445DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0177511	11/09/2001	NY	20.0	20		F	11/08/2001	Injection site soreness immediately which migrated to full arm then right torso and upper right thigh PM of 11/01/2001. Became dizzy, very hot (104)and numb on awakening and fell Tingling from neck down right side.				Y					Y	11/01/2001	11/02/2001	1	Blood work was normal	PUB	PUB	NONE	NONE	Seasonal Allergies			1						1	Dizziness; Hypoaesthesia; Injection site pain; Paraesthesia; Pyrexia	FLU3~SANOFI PASTEUR~UO685AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177512	11/09/2001	NY	70.0			M	11/08/2001	Bells Palsy (left sided facial weakness)				Y					U	11/06/2001	11/07/2001	1	Checking Lyme titer	PVT	UNK	NONE	NONE				1						1	Facial palsy	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0177516	11/09/2001	NJ	46.0	46		F	03/08/2001	It was reported that a 46 year old female patient received a Fluzone SV vaccination on 11/29/2000. Reportedly sometime after the vaccination the patient developed pain, redness and ecchymosis at the injection site. From additional correspondence received on 02/21/2001, it was reported that the patient recovered from this experience. Additional patient, vaccine administrator name and address were also provided.									Y	11/29/2000				OTH	PVT					U200100201	1						1	Ecchymosis; Injection site hypersensitivity; Injection site pain	FLU3~AVENTIS PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177517	11/09/2001	FL	35.0	35		F	03/08/2001	It was reported that a 35 year old female patient received a Fluzone SV vaccination on 11/30/2000 at 10:15 am in the left forearm. Reportedly one hour later the patient complained of itching all over her body. Medication was given approximately one hour later. The patient also complained of dizziness and throat closing and still itching. From additional correspondence received 02/21/2001, it was reported, reviewed, no additional information at this time - CD 02/14/2001. This case is closed.									N	11/30/2000	11/30/2000	0		UNK	UNK					U200100202	1						1	Dizziness; Pruritus; Throat tightness	FLU3~AVENTIS PASTEUR~U0435AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177518	11/09/2001	FL	37.0	37		F	03/08/2001	It was reported that a 47 year old female patient received a Fluzone vaccination on 11/28/2000 at 8:00 am. Reportedly on 11-29-2000 at 10:00, the patient developed a localized area of cellulitis 6cm. Reportedly the patient recovered from this experience. From additional correspondence received on 02/21/2001, it was reported, reviewed, no additional information at this time - CD 02/14/2001. This case is closed.									Y	11/28/2000	11/29/2000	1		MIL	UNK		NONE	NONE		U200100203	1						1	Cellulitis	FLU3~AVENTIS PASTEUR~U0435AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177519	11/09/2001	FL	44.0			F	03/08/2001	It was reported that a 44 year old female patient received a Fluzone SV vaccination. Reportedly sometime after receiving the vaccination the patient developed 3cm of cellulitis, urticaria and a sore throat. Further information is requested. From additional correspondence received on 02/21/2001, it was reported, reviewed, no additional information at this time - CD 02/14/2001. This case is closed.									N				UNK	UNK	UNK					U200100204	1						1	Cellulitis; Pharyngolaryngeal pain; Urticaria	FLU3~AVENTIS PASTEUR~U0435AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177520	11/09/2001	FL				F	03/08/2001	It was reported that a female patient received a Fluzone SV vaccination on 11/28/2000. Reportedly that same day the patient developed swelling and redness surrounding the injection site, itching and pain from the shoulder to the forearm. From additional correspondence received on 02/21/2001, it was reported, reviewed, no additional information at this time - CD 02/14/2001. This case is closed.									U	11/28/2000	11/28/2000	0		PVT	UNK		NONE	NONE		U200100205	1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Shoulder pain	FLU3~AVENTIS PASTEUR~U0435AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177522	11/09/2001	CA	29.0	29		M	01/23/2001	It was reported that a male patient received a Fluzone vaccination during Oct 1999. Approximately one month later the patient developed flu-like symptoms, feeling in his head like a head cold persisted. The patient has been seen by an Allergist and also has had an MRI. The MRI results were not provided.									U	10/01/1999	11/01/1999	31	MRI - results not provided.	UNK	UNK					0200100207	1						1	Influenza; Pharyngitis; Rhinitis	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177523	11/09/2001	TX	54.0	54		F	03/20/2001	It was reported that a patient (1 of 2) received a Fluzone vaccination. Sometime after the vaccination the patient developed leg cramps. No specifics were provided. Further information is requested. From additional information received on 12/7/2000, it was reported that the patient received the Fluzone SV vaccination on 11/30/2000 at 10:00 am. Reportedly at 12:01 pm that same day the patient developed pain and cramping of the right calf. The patient was seen in the ER. The patient's recovery status is unknown. Additional patient, vaccine, vaccine administrator and responsible physician information was also provided. From additional correspondence received on 03/20/2001 it was reported that the patient recovered from this experience.				Y					Y	11/30/2000	11/30/2000	0		OTH	PVT					U200100211	1						1	Muscle spasms; Pain	FLU3~AVENTIS PASTEUR~U0441AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177524	11/09/2001	TX				U	01/25/2001	It was reported that a patient (2 of 2) received a Fluzone vaccination. Sometime after the vaccination the patient developed leg cramps. No specifics were provided. Further information is requested.									U					UNK	UNK					U200100212	1						1	Muscle spasms	FLU3~AVENTIS PASTEUR~U0441AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177525	11/09/2001	IN	46.0	46		M	02/28/2001	It was reported that a 46 year old male patient received a Fluzone SV vaccination on 12/01/2000. Reportedly on 12/05/2000, the patient developed achy, stiff joints and some abdominal discomfort. These symptoms started on 12/05/2000 and are still continuing but the patient refused to be seen by the physician. From additional correspondence received on 02/20/2001, it was reported that the symptoms only lasted one day. Per physician, 02/13/2001, reviewed, no additional information at this time. This case is closed.									Y	12/01/2000	12/05/2000	4		UNK	UNK					U200100213	1						1	Abdominal discomfort; Arthralgia; Joint stiffness	FLU3~AVENTIS PASTEUR~U0417AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177526	11/09/2001	SC	38.0			F	03/14/2001	It was reported that a female patient (1 of 3) received a Fluzone SV vaccination. Reportedly the patient developed reaction of warmth, erythematous area around the injection site for 24+ hours, measuring more than 5cm and up to 10cm. Further information is requested. From additional correspondence received 03/06/2001, it was reported that the patient recovered from this experience. Additional patient, vaccine, vaccine administrator and responsible physician information were provided.									Y					PVT	PVT			Septra and Cortisporin otic allergies.		U200100214	1						1	Injection site hypersensitivity; Injection site warmth	FLU3~AVENTIS PASTEUR~U0435AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177527	11/09/2001	SC	41.0			F	03/12/2001	It was reported that a female patient (2 of 3) received a Fluzone SV vaccination. Reportedly the patient developed a reaction of warmth, erythematous area around the injection site for 24 + hours, measuring greater than 5cm and up to 10cm. Further information is required. From additional correspondence received on 03/06/2001, it was reported that the patient recovered from this experience. Additional vaccine, patient, vaccine administrator and responsible physician information were provided.									Y					UNK	UNK	B/P medication	NONE	NONE		U200100216	1						1	Injection site rash; Injection site warmth	FLU3~AVENTIS PASTEUR~U0435AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177528	11/09/2001	SC	30.0			F	03/14/2001	It was reported that a female patient (3 of 3) received a Fluzone SV vaccination. Reportedly the patient developed reaction of warmth, erythematous area around the injection site for 24+ hours after the injection, measuring > 5cm and up to 10cm. Further information is requested. From additional correspondence received on 03/06/2001, it was reported that the patient recovered from this experience. Additional patient, vaccine administrator and the responsible physician information were also provided.									Y				NONE	PVT	UNK		NONE	Pregnant - second trimester.		U200100217	1						1	Injection site rash; Injection site warmth	FLU3~AVENTIS PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177529	11/09/2001	TN	45.0	45		F	03/08/2001	It was reported that a 45 year old female patient received a Fluzone SV vaccination on 10/16/2000 at 8:30 am. During the evening of 10/16/2000 the patient developed a large red circle on her left arm, that was raised and hot to the touch. In the morning of 10/17 the patient developed itching all over and her knees became red. Developed redness up to mid-chest. Also developed sores from the waist down. On 10/19 physician saw the patient. The patient's  recovery status is unknown. From additional correspondence received on 02/21/2001, it was reported that the patient is still in treatment. The correct vaccination time was also provided.				Y					U	10/16/2000	10/16/2000	0	Vasculitis 11/30/2000 from biopsy.	PVT	UNK		NONE	NONE		U200100218	1						1	Erythema; Injection site hypersensitivity; Injection site swelling; Injection site warmth; Pruritus; Skin ulcer; Vasculitis	FLU3~AVENTIS PASTEUR~U0398AA~1~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177530	11/09/2001	MO	51.0	51		F	03/08/2001	It was reported that a 51 year old female patient received a Fluzone SV vaccination  on 11/29/2000. Reportedly on 12/05/2000, the patient developed systemic rash all over her body. The patient was given Xanax, Prednisone and Atarax. The rash was still persisting on 12/07/2000. The patient was diagnosed with fibromyalgia and migraine headaches and mixed tissues symptoms. The nurse stated that she is on lots of pharmaceuticals. From additional information received on 12/08/2000, it was reported the patient developed a rash approximately 48 hours after receiving the flu vaccine, not on 12/05/2000 as previously reported. Rash is pruritic and covers the majority of her body with the exception of her face, hands and feet. The patient is still complaining of symptoms on 12/07/2000. From additional correspondence received on 02/21/2001, it was reported, the patient has been previously diagnosed with fibromyalgia and migraine headaches and mixed tissue symptoms, was not diagnosed as previously reported.				Y					N	11/29/2000	12/01/2000	2		PVT	PVT	Zaroxolyn, Prednisone, Darvocet N 100, Diazepam, Zovirax, Celexa, Elavil, Combi Patch, Allegra and Plaquenil.	NONE	Fibromyalgia, hiatal hernia, seasonal allerigies, hypercholesterolemia, connective tissue disorders, fever blisters, and MVP.		U200100219	1						1	Migraine; Rash pruritic	FLU3~AVENTIS PASTEUR~U0414BB~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177531	11/09/2001	RI	77.0	77		F	01/25/2001	It was reportedd that a 77 year old female patient received a Fluzone SV vaccination on 11/29/2000. Within 30 minutes after the injection the patient developed tingling in and around her mouth, no respiratory distress and increased anxiety. The patient was transferred by rescue squad to the ER, treated and released to the family physician.				Y					U	11/29/2000	11/29/2000	0		UNK	UNK					U200100220	1						1	Anxiety; Paraesthesia	FLU3~AVENTIS PASTEUR~U0434AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177533	11/09/2001	FL	50.0	50		F	03/08/2001	It was reported that a 50 year old female patient received a Fluzone SV vaccination on 12/01/2000 in the PM. Reportedly the day after the vaccine was administered, the patient developed a 5 area of hardness, heat, redness and pain. The patient had no fever. The symptoms lasted for 3 days. the hard know remained through 12/05/2000. Reportedly the patient recovered from this experience. From additional correspondence received on 02/21/2001, it was reported, reviewed, no additional information at this time. This case is closed.									Y	12/01/2000	12/02/2000	1		PVT	PVT		NONE	Allergic to penicillin.		U200100222	1						1	Injection site hypersensitivity; Injection site induration; Injection site pain; Injection site warmth	FLU3~AVENTIS PASTEUR~U0435AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177535	11/09/2001	PA	48.0			M	01/25/2001	It was reported that a 48 year old male patient received a Fluzone SV vaccination on 12/05/2000. Reportedly sometime after the vaccination the patient developed a local reaction of redness, hardness and pain at the injection site.									U	12/05/2000				UNK	UNK					U200100224	1						1	Injection site hypersensitivity; Injection site induration; Injection site pain	FLU3~AVENTIS PASTEUR~U043DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177536	11/09/2001	WA	39.0	39		F	01/25/2001	It was reported that a 39 year old female patient received a Fluzone SV vaccination on 12/04/2000. Sometime after the vaccination the patient developed a local reaction, 4cm red, swollen tender area at the injection site which lasted for 3 days.									U	12/04/2000				UNK	UNK					U200100225	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~AVENTIS PASTEUR~U0400AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177538	11/09/2001	CA	61.0	61		F	01/25/2001	It was reported that a 61 year old female patient received a Fluzone SV and a Pneumovax vaccination on 12/05/2000. Approximately 5 hours after vaccination, the patient developed general malaise, difficulty on expiration and stomach pain, which lasted approximately 40 hours and completely subsided.									Y	12/05/2000	12/05/2000	0		UNK	UNK					0200100227	1						1	Abdominal pain upper; Dyspnoea; Malaise	FLU3~AVENTIS PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177541	11/09/2001	IN	44.0	44		F	03/10/2001	It was reported on 12/12/2000, the patient developed a fever of 101F, severe body aches and malaise for approximately 5 hours. Also developed redness and swelling at the site. The patient's muscles ached for about 12 hours. The patient was treated with Tylenol.									U	12/11/2000	12/12/2000	1		OTH	UNK		NONE	NONE		U200100230	1						1	Injection site hypersensitivity; Injection site oedema; Malaise; Myalgia; Pain; Pyrexia	FLU3~AVENTIS PASTEUR~U0454AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177542	11/09/2001	IA	45.0	45		F	03/27/2001	Reportedly about 45 minutes after vaccination, the patient complained of severe pain in the left deltoid radiating to the hand and clavicle. The patient still experiences sporadic pain, especially at night when trying to sleep. The patient was seen in the ER on 10/18, treated and released. On 11/01/2001 seen by family physician who ordered physical therapy for 1 week - no relief. On 11/14/2001 the patient was referred to an orthopedic surgeon. The patient now an appt with a neurologist next week. From additional correspondence received on 02/22/2001, it was reported neurologist appt cancelled initially due to decreased pain in arm. Approximately the second week of January 2001, numbness and tingling started from the shoulder to the fingertips with occasional pain. Rescheduled appts 02/28/2001. On 03/14/2001 the patient had her appt with the neurologist. The physician also states there is probably muscle reaction to the vaccine itself. The patient continues to have numbness and tingling in the left arm and hand occasionally with occasional pain in the deltoid, as of 03/21/2001.				Y					N	10/18/2000	10/18/2000	0	Nerve conduction study = wnl	PUB	UNK					U200100231	1						1	Hypoaesthesia; Injection site pain; Myalgia; Paraesthesia; Sleep disorder	FLU3~AVENTIS PASTEUR~U0399AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177544	11/09/2001	FL	7.0	7		M	03/14/2001	Reportedly, 15-20 minutes after the vaccination, the patient developed wheezing, itching all over and runny eyes. The patient was treated with Benadryl and Albuterol. The patient recovered from this experience.									Y	12/14/2000	12/14/2000	0		PVT	UNK			Kabuki syndrome, asthma and development delay.		U200100236	1						1	Asthma; Lacrimation increased; Pruritus	FLU3~AVENTIS PASTEUR~U0415AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177545	11/09/2001	NY				F	01/26/2001	Post vax, the patient reportedly developed Bells Palsy with left facial nerve paralysis. The patient was evaluated by a physician, underwent an MRI and a lumbar puncture. Steroid therapy was prescribed. The resolution is unknown.				Y					U	11/15/2000	11/16/2000	1	MRI and Lumbar puncture - results not provided.	UNK	UNK					U200100239	1						1	Facial palsy	FLU3~AVENTIS PASTEUR~U040AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177546	11/09/2001	CO	66.0	66		F	05/04/2001	The patient reportedly developed heartburn immediately after the vaccination. The patient took Alka-Seltzer and the heartburn was resolved. From additional correspondence received 05/01/2001, it was reported there is no additional information available at this time. This case is closed.									Y	01/05/2001	01/05/2001	0		PVT	PVT		NONE	Allergic to Epinephrine, Tylenol and Cortisone.		U200100282	1						1	Dyspepsia	FLU3~AVENTIS PASTEUR~U0444AB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177547	11/09/2001	PA	20.0	20		F	01/28/2001	Reportedly at 6:20pm the patient complained of feeling of fullness in her chest. There was no wheezing. The patient was treated with Benadryl and given instructions to follow-up. There was no induration at the injection site. Reportedly the patient recovered from this experience.									Y	10/26/2000	10/26/2000	0	UNK	OTH	PVT		NONE	NONE		U200100284	1						1	Chest pain	FLU3~AVENTIS PASTEUR~U0402CA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177548	11/09/2001	PA	14.0	14		F	03/14/2001	The evening of the injection, the injection area on the left upper arm was red, slightly raised and very sore. The erythema was approximately 3 long and 3/4 wide and felt hot to the touch. Stayed like this for 5 days. As of 01/09/2001, the area is no longer sore and the red strip is very slight but still visible on her arm. Additional correspondence received on 02/15/2001 reported that the patient recovered from this experience. It was requested on 02/12/2001 to send a copy of this report to MD. No further information was provided from correspondence returned on 03/08/2001.									Y	12/28/2000	12/28/2000	0		OTH	UNK		NONE			U200100287	1						1	Injection site hypersensitivity; Injection site pain; Injection site rash; Injection site swelling; Injection site warmth	FLU3~AVENTIS PASTEUR~UO3454AC~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177549	11/09/2001	PA	47.0	47		F	05/03/2001	It was reported that the patient experienced a local reaction the next day after the vaccination with a slightly raised, red rash the size of your hand. It was painful, itchy and she had some neuritis and numbness the length of her arm, radiating from the vaccination site. The patient also had muscle soreness. The patient was treated with Benadryl and Excedrin, which alleviated her symptoms. From additional correspondence received on 04/20/2001, it was reported that the patient recovered from this experience. This case is closed.									Y	01/04/2001	01/05/2001	1		OTH	PUB		NONE	Allergic to penicillin, sulfa, stinging insects, and all diagnostic contrast dyes.		U200100288	1						1	Hypoaesthesia; Myalgia; Neuropathy peripheral; Pain; Rash erythematous; Rash pruritic	FLU3~AVENTIS PASTEUR~U0466AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177550	11/09/2001	TX	42.0	42		M	01/28/2001	It was reported that a 42 year old male received Fluzone SV '00-'01 USP from his Employee Health on 12/7/00. Within several days, he had arthritic-like pain in his shoulder and joint where vaccine was given. The was also a round, raised rash. The doctor put him on Prednisone 6 day pack. Now, 1 month later, there is a scaly, psoriasis-looking rash that is bumpy and scabbed over and 1/2 in diameter.				Y					N	12/07/2000	12/09/2000	2		OTH	OTH					U2001002940	1						1	Arthralgia; Injection site rash	FLU3~AVENTIS PASTEUR~U0439EA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177551	11/09/2001	MI	41.0	41		F	03/10/2001	A few days after the vaccination, the patient reportedly developed a local reaction at the injection site and then developed Pityriais-Rosea. No further information is anticipated. This case is closed.									U	12/16/2000				PVT	PVT		NONE	NONE		U200100295	1						1	Injection site reaction; Pityriasis rosea	FLU3~AVENTIS PASTEUR~U0454AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177552	11/09/2001	PA	41.0	41		F	05/03/2002	From an initial report received on 01/12/01, it was reported that a 41 year old female was given Fluzone SV '00 -'01 vaccine on 01/09/01. patient reportedly developed edema and joint pain- elbow, wrists and ankles and fingers, also neck pain the evening after vaccination still persist. From additional correspondence received on 02/16/01, additional patient, vaccine, responsible physician and vaccine administrator information was provided.									N	01/09/2001	01/10/2001	1	NONE	OTH	PUB		NONE	Unspecified drug allergies.		U200100297	1						1	Arthralgia; Neck pain; Oedema	FLU3~AVENTIS PASTEUR~UO460AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177553	11/09/2001	MI	39.0	39		F	03/10/2001	The patient reportedly experienced left arm pain, a burning sensation and swelling on 01/11/2001 after being seen by a private physician. The patient was treated with ibuprofen. From additional correspondence received on 02/27/2001, it was reported the patient is currently being treated for bursitis. The Dr advised these symptoms were not caused by the flu vaccine. No further information is anticipated. This case is closed.				Y					U	12/28/2000	12/28/2000	0		OTH	PVT		NONE	UNK		U200100299	1						1	Bursitis; Injection site oedema; Injection site pain; Skin burning sensation	FLU3~AVENTIS PASTEUR~U0447AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177555	11/09/2001	MI	51.0	51		M	04/04/2001	Post vax, the patient reportedly experienced weakness in both feet and legs, uncoordinated, and swelling of both hands. The patient was evaluated by a neurologist. There was no confirmed diagnosis. The symptoms lasted 2 weeks and have resolved.				Y					Y	11/19/2000	11/26/2000	7	EMCT done, ANA/SED rate elevated	OTH	OTH		NONE			U200100302	1						1	Asthenia; Coordination abnormal; Oedema peripheral; Red blood cell sedimentation rate increased	FLU3~AVENTIS PASTEUR~U0434AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177556	11/09/2001	NY	20.0	20		F	01/29/2001	From a report received on 01/04/01, it was reported that 10 minutes after pt received her vaccine, her entire arm became itchy with redness from itching at hand between thumb and forefinger. Treatment of Benadryl given with relief after 10-20 minutes.									Y	11/15/2000	11/15/2000	0		OTH	UNK	Prevacid	NONE	Allergic to beans and peas		u200100303	1						1	Erythema; Injection site hypersensitivity; Pruritus	FLU3~AVENTIS PASTEUR~U0399BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177557	11/09/2001	CO	64.0	64		F	03/10/2001	About 6 hours after pt received vaccine she developed tachycardia-120 bpm. The pt was seen in ER. Pt was back to normal in 2 or 3 days. From additional correspondence received on 02/27/01, additional pt, responsible Dr, vaccine administrator and laboratory data were provided. No further information is anticipated. This case is closed.				Y					Y	11/21/2000	11/21/2000	0	In ER EJG -sinus tachycardia was negative, 115 BPM-89 on EKG, VQ lung scan-negative and chest x-ray negative.	PVT	OTH	Prempro	NONE	Benign positional vertigo, HTN, Palpitations & possible undocumented paroxysmal SVT		U200100320	1						1	Tachycardia	FLU3~AVENTIS PASTEUR~U0405AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177558	11/09/2001	NJ	33.0	33		F	02/12/2001	It was reported that immediately after vaccination the pt could taste the vaccine, had esophageal spasms and a burning and nasal sensation, no respiratory distress or anaphylaxis. These symptoms lasted about 1/2 hour. Pt took Benadryl and was also seen in the emergency room. Further information is requested.				Y					U	01/10/2001	01/10/2001	0		OTH	OTH					U200100397	1						1	Dysgeusia; Nasal discomfort; Oesophageal spasm	FLU3~AVENTIS PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177559	11/09/2001	PA	61.0	61		F	02/15/2001	It was reported that 3- 4 days after receiving vaccine the pt's hair fell out. Pt had same experience with Hepatitis A & B vaccines, she lost 3/4 of her hair volume in 1998. Further information is requested.									U	11/01/2000	11/04/2000	3		OTH	OTH					U200100417	1						1	Alopecia	FLU3~AVENTIS PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177560	11/09/2001	NY	42.0	42		F	03/02/2001	Right after vaccinations the pt complained of feeling hot, clammy, and woozy and a light headache, skin color flushed. Pt was sidephhoretic. Pt had blood pressure taken several times until was normal. Pt stated that she felt hot and complained of tingling in both feet. Stated throat felt slightly tight when swallowing. No erythema on right or left arm. Pt stated she felt lightheaded. Pt given Epinephrine and Claritin with samples of Claritin to take home. At 1:25 pt still complained of tingling left arm and left leg but no signs or symptoms of distress. Was discharged per Dr.				Y					Y	01/29/2001	01/29/2001	0		OTH	OTH	Naproxen	NONE	NONE		02001004430	1						1	Cold sweat; Dizziness; Feeling hot; Flushing; Headache; Paraesthesia; Throat tightness	FLU3~AVENTIS PASTEUR~U0450AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|JEV~CONNAUGHT LABORATORIES~196B~2~SC~RA~JAPANESE ENCEPHALITIS (J-VAX)~1|TYP~CONNAUGHT LABORATORIES~R1170~UNK~~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0177562	11/09/2001	OH				F	04/09/2001	Two days after vaccination pt presented with redness, swelling, warmth, and inflamed area. Seen by physician and diagnosed with cellulitis. Antibiotics were prescribed and pt is responding to treatment. Additional correspondence received on 04/06/2001, it was reported that the pt recovered from this experience.				Y					Y	03/13/2001	03/15/2001	2	NONE	OTH	PVT		NONE	NONE		U200100517	1						1	Cellulitis; Injection site erythema; Injection site inflammation; Injection site reaction; Injection site swelling; Injection site warmth	FLU3~AVENTIS PASTEUR~U0457AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177565	11/09/2001	PA	46.0	46		F	05/03/2001	From an initial report dated 04/20/01, it was reported a pt vaccinated on 01/04/2001 pt had a local reaction the next day. the pt developed a slightly raised, red, rash, the size of your hand. It was painful, itchy and she had some neuritis and numbness the length of her arm radiating from vaccination site. She also had muscle soreness. Spoke with her and she had just taken Benadryl and Excedrin on day 3. That did alleviate her symptoms. She is going to try to get the lot number from her vaccine. Pt called in 01/10/2001 with lot number.									Y	01/04/2001	01/05/2001	1		UNK	UNK					U200100678	1						1	Injection site pain; Pruritus; Rash erythematous	FLU3~AVENTIS PASTEUR~UA466AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177566	11/09/2001	PA	62.0	62		F	05/14/2001	It was reported that a 62 year old female pt received a Fluzone SV 00-01 vaccination in 11/00. Reported ten days after vaccination the pt developed painful spot on index toe on foot. After the first of the year (Jan 2001) the pt developed painful spots on right side of back-possible atypical shingles									U	11/01/2000	11/10/2000	9		OTH	OTH	NONE	NONE			02001007100	1						1	Herpes zoster; Infection; Pain in extremity	FLU3~AVENTIS PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177567	11/09/2001	CT		62		F	07/13/2001	After receiving vaccines, the pt developed numbness of the right deltoid, onset date not specified, which had progressively improved. From correspondence received on 06/29/01 it was stated shortly after vaccination pt's arm was like it was dead. To hold a cup of tea left hand had to pick right hand up-weak. Gradually gone, reported 100% return to normal on 06/12/01.									Y	01/03/2001				PVT	PVT	Accupril, HCTZ, Premarin, Fosmax, Ambien, Aspirin	NONE	Decreasing hearing-left, 5 unsuccessful pregnancies, TAHBS, seasonal allergies, HTN, GERD, LS Disc herniation, Osteoporosis, High cholesterol, Eczema		02001007340	1						1	Hypoaesthesia; Muscular weakness	FLU3~AVENTIS PASTEUR~U0449AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~463016~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0177568	11/09/2001	FL	76.0	76		M	07/13/2001	It was reported that an 76 year old male pt received a Fluzone SV 00-01 vaccination in 11/2000. Reportly sometime after the vaccination (date not specified) the pt developed headaches, diaphoresis, abdominal pain, myalgia, and mouth. No further information was provided from mailed correspondence returned on 06/29/2001.									N	11/01/2000			Negative laboratory studies	PVT	OTH		Prostate cancer, Arthritis			U200100739	1						1	Abdominal pain; Dry mouth; Headache; Hyperhidrosis; Myalgia	FLU3~AVENTIS PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177584	11/12/2001	NY	58.0	58		M	11/06/2001	Information has been received from a woman in a physician's office concerning a 58 year old Caicasian male pt with hyperlipidemia and coronary artery disease and no known allergies and a history of asbestos exposure who on 10/18/2001 was vaccinated in the right arm with a second dose of pneumococcal vaccine 23 polyvalent. Concomitant vaccinations on 10/18/01 included a second dose in the right arm of Fluvirin. Other concomitant therapy included atenol, lisinopril, aspirin and hydrochlorothiazide. Subsequently, the patient developed erythema with 3+ edema. The affected area was from the injection site(deltoid)to his wrist, affecting his upper arm and forearm. It was reported that his arm was so bad that he couldn't touch his head. He was started on prednisone over the weekend (on approximately 10/20/20010. The condition was reported to not be resolving so that patient was started on amoxicillian trihydrate (+)Clavulanate potassium 875 mg twice daily for cellulitis. The reporter indicated that she thought the patient was improving because their office had not heard anything further from him. The reporter expressed a concern with the lot since 3 patients received the vaccine and have had reaction. FOLLOW-UP information from a physician indicated that the patient developed swelling, erythema, pain of right arm from injection site to wrist, with a fever of 101. The patient was treated with antibiotics with resolutiuon of symptoms over approximately 10 days. No further information is availble.				Y					Y	10/18/2001	10/19/2001	1		PVT	OTH	aspirin; Tenormin; hydrochlorothiazide; Zestril		Asbestos exposure; Coronary artery disease; hyperlipidemia		WAES01104569	1						1	Cellulitis; Hypokinesia; Injection site erythema; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0944K~2~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0177592	11/12/2001		38.0	38		F	10/29/2001	Pt experienced an anaphylactic reaction within 15 minutes of receiving vax. Pt required medical intervention, intubation and hospitalization in ICU.			Y		Y				U	10/29/2001	10/29/2001	0		OTH	OTH			Allergy to cats, penicillin, cigarette smoke; possibly slightly allergic to eggs; asthma			1						1	Anaphylactic reaction	FLU3~SANOFI PASTEUR~U0675AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0177600	11/12/2001	ME	43.0	43		F	10/29/2001	Febrile illness with adrenal insufficiency in pt with Addison's disease.					Y	2			Y	10/26/2001	10/27/2001	1	Labs-WNL	PVT	PVT	Cortef; Florinef		Addison's disease			1						1	Adrenal insufficiency; Pyrexia	FLU3~EVANS VACCINES~E09871LA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1071K~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0177601	11/12/2001	TN	67.0	67		F	10/15/2001	Pt noted some itching at site of injection about an hour after receiving vaccine. Itched until about 8:00 pm 10/03/2001. Pt called back to state (10/04/2001, 4:00 pm) that the arm was red, hard, swollen, tender, and warm. No elevation of temperature noted. Much improved by 3 days.									Y	10/03/2001	10/03/2001	0		PUB	PUB	Thyroid medication	NONE	Thyroid condition		TN01054	1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling; Injection site warmth; Pruritus	FLU3~EVANS VACCINES~E00961HA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1456K~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177602	11/12/2001	FL	53.0	53		F	10/31/2001	The patient complained of flu like symptoms; body aches and chilly feeling. The patient developed redness at the injection site in an 3 cm area. The redness, swelling and pain increased on 10/30/2001 with swelling to the elbow.									U	10/29/2001	10/29/2001	0		PUB	PUB	Nasocort, Serevent, Albuterol, Atrovent	NONE	Emphysema		FL01014	1						1	Feeling cold; Influenza like illness; Injection site erythema; Injection site pain; Injection site swelling; Pain	FLU3~SANOFI PASTEUR~U0681AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1456K~2~IM~LL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177603	11/12/2001	IN	40.0	40		F	11/05/2001	Post vax, the patient complained her index finger and thumb on her left hand went completely numb, preceded by tingling.									Y	10/31/2001	10/31/2001	0	NONE	PVT	PVT	Glucophage, cozaar, cholestin	NONE	DM Type II, GERD, Hypertension			1						1	Hypoaesthesia; Paraesthesia	FLU3~SANOFI PASTEUR~E08791LA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177604	11/12/2001	SC	69.0	69		F	10/31/2001	The patient complained of redness, swelling, itching and warmth to the injection site.									Y	10/29/2001	10/29/2001	0		PUB	PUB		NONE			SC0156	1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U05910A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~474936~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0177605	11/12/2001	SC	70.0	70		M	10/31/2001	The patient's spouse reports the patient had a local reaction to the left arm with redness and swelling at the injection site.									Y	10/29/2001	10/29/2001	0		PUB	PUB		NONE	NONE		SC0155	1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U0591DA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~474936~UNK~IM~LA~PNEUMO (PREVNAR)~1	USA		Influenza
0177606	11/12/2001	TN	73.0	73		F	11/05/2001	The patient complained of soreness and redness at the injection site the day after the vaccination. The area around the injection site was approximately 6 long and 4 wide and was raised and red. The patient was treated with Benadryl and Tylenol.									Y	10/30/2001	10/31/2001	1		OTH	PVT	Pravachol, Verapamil	NONE	NONE			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U0691AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0995L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177607	11/12/2001	MI	79.0	79		F	11/02/2001	Approximately seven hours post vaccine the patient had a sudden onset of vertigo, near syncope and several episodes of vomiting. 911 was called by the family. The patient's vital signs were checked, but the patient declined treatment or transport to the hospital.									Y	10/29/2001	10/29/2001	0	NONE	PVT	UNK	Lipitor, HCTZ, Toprol, Persantine, ASA, Celebrex, Xalatan, Occupres, Calcium and Vitamin D, Multivitamin, Glucosamine	NONE	Environmental allergies, HTN, TIA, ASHD, Arthritis, Glaucoma, Cataracts, Hyperlipidemia			1						1	Syncope; Vertigo; Vomiting	FLU3~SANOFI PASTEUR~U0575AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177608	11/12/2001	MI	56.0	56		F	11/05/2001	The patient developed hives over her entire body starting from her feet and spreading upwards around 5:30 pm, 11/03/2001.									Y	11/03/2001	11/03/2001	0	NONE	PUB	PVT	NONE	NONE	Scoliosis, polio-post polio syndrome			1						1	Urticaria	FLU3~PFIZER\WYETH~4018023~4~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0177609	11/12/2001	TN	76.0	76		F	10/26/2001	The patient experienced soreness overnight and swelling to the elbow. The patient was seen in the office and her left arm was swollen the elbow and warm to the touch.									U	10/24/2001	10/24/2001	0		OTH	OTH	Lipitor, Lanoxin, Nifedipine, Isosorbide, Celebrex, Premarin					1						1	Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U0681AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~470592~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0177610	11/12/2001	TN	40.0	40		F	10/26/2001	Within 10 minutes post vax, the patient experienced heart arrhythmia, her airway was tight, she was nauseous and sweating. Patient was treated with Epipen and taken to ER. Doctors determined her reaction was due to lactose intolerance.				Y					Y	10/26/2001	10/26/2001	0		OTH	OTH						1						1	Arrhythmia; Hyperhidrosis; Nausea; Throat tightness	FLU3~SANOFI PASTEUR~U0681AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177611	11/12/2001	MA	29.0	29		F	11/01/2001	Post vax the patient reported itching and redness of the left deltoid.									U	11/01/2001	11/01/2001	0	Allergy tests	PUB	PVT	Ibuprofen, Allegra, Albuterol inhaler	NONE	Allergies			1						1	Injection site erythema; Injection site hypersensitivity; Pruritus	FLU3~SANOFI PASTEUR~U0678CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177612	11/12/2001	CA	57.0	57		F	11/05/2001	The patient reported redness and pain at the injection site in an area 4 in diameter. The patient complained of pain from the elbow to the shoulder. Symptoms subsided in 5 days.									Y	11/01/2001	11/01/2001	0	NONE	OTH	OTH		NONE	NONE			1						1	Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U0592AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177613	11/12/2001	WI	59.0	59		M	10/31/2001	The patient developed cellulitis one day post vax.				Y					U	10/29/2001	10/30/2001	1	NONE	PVT	PVT	Coumadin, Prevacid, Vitamin E		Aortic Valve Replacement			1						1	Cellulitis	FLU3~SANOFI PASTEUR~U0678EA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0945K~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0177614	11/12/2001	MI	82.0	82		F	10/25/2001	On 10/19/2001 the patient developed flu like symptoms which gradually worsened. The patient complained of chills, hot and cold, cough, red and sore upper palate and throat, sore tongue, sore joints and loss of appetite. The patient was treated with Xylocaine gel, Swish and Swallow, and Tylenol.				Y					Y	10/18/2001	10/19/2001	1	CXR, Labs	PVT	PVT		NONE	Allergies; sulfa, penicillin			1						1	Anorexia; Arthralgia; Chills; Cough; Glossodynia; Influenza like illness; Pharyngolaryngeal pain; Stomatitis	FLU3~SANOFI PASTEUR~U0678AA~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177615	11/12/2001	CA	76.0	76		F	11/10/2001	Post vax, the patient complained of a sick feeling, very tired, loss of appetite, leg cramps and facial flush. These symptoms lasted 7 days.									Y	10/17/2001	10/18/2001	1	NONE	PVT	PVT	Inderal, Pnemona, Provera, Plendil, ASA, Oscal, St John's Wort, Lithium, Ginko baloba	NONE	HTN, cataract, lumbar stenosis, asthma, anxiety, hyperlipidemia, peripheral neuropathy			1						1	Anorexia; Fatigue; Flushing; Malaise; Muscle spasms	FLU3~EVANS VACCINES~E02741HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0177616	11/12/2001	TX	52.0	52		F	11/04/2001	Post vax, the patient developed abdominal hives, palmar itching, swelling and angioedema of her lip.									Y	11/03/2001	11/03/2001	0	NONE	MIL	MIL	Estradiol, Actenol	NONE	Allergic rhinitis, perenial mild			1						1	Angioneurotic oedema; Pruritus; Swelling; Urticaria	FLU3~SANOFI PASTEUR~674AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177617	11/12/2001	MI	58.0	58		M	10/04/2001	Ten minutes post vax the patient complained of feeling shakey and his throat feels tight. The patient was treated with Benadryl.				Y					Y	10/04/2001	10/04/2001	0		PUB	PUB	Lipitor, Lasix, Toprol, Celebrex, Imdur, Captopril, Neurontin, ASA	CAD, Smoker, Hyperlipidemia, S/P Stent Placement			MI2001084	1						1	Throat tightness; Tremor	FLU3~SANOFI PASTEUR~U0574AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177618	11/12/2001	MI	23.0	23		F	10/19/2001	Post vax the patient developed a blister on her left arm and her left arm was swollen. There was no evidence of cellulitis.				Y					U	10/16/2001	10/18/2001	2		PUB	UNK	Prednisone, Synthroid, Procardia, Plaquenil, ASA, Calcium	Headaches, Lupus	Allergic to Penicillin		MI2001086	1						1	Injection site swelling; Injection site vesicles	FLU3~SANOFI PASTEUR~U0574AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1070K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0177619	11/12/2001	CA	61.0	61		F	11/02/2001	Post vax the patient developed swelling and reddening of the right deltoid. The patient was treated with cold compresses.									U	11/01/2001	11/02/2001	1		OTH	OTH	Fosomax, Atrovent, Tylenol 3	Chronic bronchitis, osteoporosis, post menopausal dysuria.				1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U0688AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1043L~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177620	11/12/2001	AL	36.0	37		F	10/31/2001	Post vax the patient complained of swelling arms, nausea, and headaches.									U	10/29/2001	10/30/2001	1		PVT	UNK	NONE	Pharyngitis			AL0112	1						1	Headache; Nausea; Swelling	FLU3~SANOFI PASTEUR~U0672AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~474939~UNK~IM~LA~PNEUMO (PREVNAR)~1	USA		Influenza
0177621	11/12/2001	VA	43.0	43		F	10/15/2001	Post vax the patient experienced vesicular eruptions, erythema, warmth and induration  at the injection site, a mild headache, myalgia and a low grade fever.				Y					Y	09/28/2001	10/05/2001	7	NONE	PVT	PVT	HCTZ, Serevent, Flovent, Singulair, Fiorinal, Atuss MS	NONE	Asthma, Migraines	Fever & Chills~Pneumo (Prevnar)~~42.00~In Patient		1						1	Erythema; Headache; Injection site induration; Injection site warmth; Myalgia; Pyrexia; Rash vesicular	FLU3~EVANS VACCINES~E02761HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0177622	11/12/2001	NY	78.0	78		F	10/26/2001	Post vax the patient developed a swollen arm, painful to touch. The patient was treated with Tylenol and recovered.									Y	10/12/2001	10/12/2001	0		UNK	UNK		NONE				1						1	Pain; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0177623	11/12/2001	MS	47.0	47		F	10/25/2001	Post vax the patient developed a very inflamed area 7-8 cm /809 cm in diameter, bruised in the middle. The right arm was very sore and could not be picked up without using the left arm. The patient was treated with Benadryl and ice packs.									U	10/22/2001	10/23/2001	1	NONE	PUB	UNK		NONE			MS01055	1						1	Contusion; Injection site inflammation; Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~U0601AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~472210~1~IM~RA~PNEUMO (PREVNAR)~1	USA		Influenza
0177624	11/12/2001	OR	65.0	65		F	10/18/2001	The patient felt sick for a few minutes post vax. The next day the patient had swelling that lasted a few days, the size of a baseball. The patient's arm is now bruised, but clearing.									Y	10/11/2001	10/12/2001	1	NONE	OTH	UNK		NONE			OR200142	1						1	Contusion; Injection site swelling; Nausea	FLU3~SANOFI PASTEUR~0588AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177625	11/12/2001	MN	43.0	43		F		The patient's arm was red, warm and ached after vaccination.									Y	11/02/2001	11/03/2001	1		PVT	PUB						1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U0685AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177626	11/12/2001	MN	5.0	5		M	11/01/2001	Redness, warmth and swelling developed 36 hours post vaccine with the left arm measuring 4 cm larger than the right. Probable cellulitis.				Y					U	10/30/2001	10/31/2001	1	NONE	PVT	PVT		NONE	History of viral induced bronchospasm			1						1	Cellulitis; Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U0591AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177627	11/12/2001	TN	68.0	68		F	11/05/2001	The patient complained of soreness, redness, and warmth around the vaccination site the day after injection. The affected area was 2 wide x 4 long and was slightly raised. After 3 days the area was still slightly sore, but the redness was gone.									Y	10/30/2001	10/31/2001	1		OTH	PVT	Evista, Spironolactone, Multivitamin, Echinacia	NONE	NONE			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U0691AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0995L~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177628	11/12/2001	NJ	44.0	44		F	11/05/2001	Post vax the injection site was red, hot and itchy. The patient had hives on her chest and abdomen. The patient was treated with Medrol Dispenspack and Zyrtec.									Y	09/24/2001	09/27/2001	3		PVT	PVT	Lithium	None	Sulfa and acetameniphen			1						1	Injection site erythema; Injection site hypersensitivity; Injection site warmth; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0593AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177629	11/12/2001	TX	52.0	52		F	11/01/2001	The patient developed redness and itching at the injection site in an area 50mm long x 10mm wide. The patient was treated with cold packs and Claritin.									U	10/31/2001	11/01/2001	1	NONE	PVT	PVT	Zocor, Claritin, Premarin, Flonase	High Cholesterol	Heart Murmur, Hay fever, Arthritis, High Cholesterol, Allergic to Sulfa			1						1	Injection site erythema; Injection site hypersensitivity; Pruritus	FLU3~SANOFI PASTEUR~U0682AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176911	11/14/2001		77.0	77		F	11/13/2001	On an unknown date in 1/00, the pt experienced paresthesia, pain in toes and paresis of inferior limbs, 2 months after receiving the Fluvirin vaccine. The reporter assessed the relationship of the study medication to the event as probable. A follow-up report was received from the relevant health professional on 10/20/00, which confirmed the event dx as leg neuropathy. Therapeutic measure taken as a result of the event included vitamin B and acupuncture. The pt had received a previous vaccination in 9/99.								Y	N	11/01/1999	01/01/2000	61	EMG-5/00-concluded that the pt had polyneuropathy, sensitive axonal polyneuritis type	OTH	OTH	Aldactazine, hyperium, lipanthyl, serevent and flucticasone.		Hypertension; hyperlipidaemia; scleroderma; asthma; venous insufficiency and sural phlebitis on the left limb (calf) and thrombophlebitis (lower extremities)		PJP2001002910	1						2	Neuropathy; Pain; Paraesthesia; Paresis; Polyneuropathy	FLU3~MEDEVA PHARMA, LTD.~~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Disabling	Influenza
0177324	11/14/2001	KS	34.0	34		F	11/09/2001	A physician reported that a 34 year old female received Flu-Shield (2001-2002) vaccine on 11/06/01. One hour, post vax, she experienced fullness in her throat, an inability to swallow, felt funny, had a bad taste in her mouth, strange vision, generalized itching and her lips felt swollen. She was treated with adrenaline SC (Epinephrine), diphenhydramine IM (Benadryl), fexofenadine hydrochloride (Allegra) and was started on a prednisone pack. She then fell asleep. This case was considered serious since these events required treatment with adrenaline SC (Epinephrine). No additional information was available as of the date of this report. The reporter indicated that 3 people received Flu-Shield (2001-2002) vaccine and subsequently, developed itching around the mouth and feeling funny; however, the other 2 pts are not presently identifiable. Additional reports will be generated when identifying information is provided. F/U information received on 12/3/01 from a pharmacist. Pharmacist deleted strange vision, funny feeling and generalized itching from adverse event report. Pharmacist reported that the pt developed itchy eyes. The pt recovered. The Pharmacist is the one who previously reported this, not the physician as was stated first.				Y					Y	11/06/2001	11/06/2001	0	UNK	PUB	PUB	NONE	NONE	UNK		HQ8216508NOV2001	1						2	Anaphylactic reaction; Dysphagia; Eye irritation; Swelling face; Throat tightness	FLU3~PFIZER\WYETH~4018033~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4018033~UNK~IM~GM~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0177692	11/14/2001	NJ	63.0	63		F	10/31/2001	Approximately 12 hours post vax the patient developed joint pain, muscle aches, and a mild sore throat. These symptoms resolved in 24 hours without treatment.									Y	10/23/2001	10/23/2001	0		PUB	PUB	Insulin and anxiety medicine	Bladder infection	Allergies to flies, fish, PCN, tetracycline, sulfur, etc.		NJ200120	1						1	Arthralgia; Myalgia; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U0597AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177700	11/15/2001	NY	26.0	26		F	11/13/2001	The day after receiving flu vax, pt felt weak and had muscle aches. On 11/6/01, pt fainted and lost control of limbs (arms and legs paralyzed). She was admitted to ICU. She remains in ICU at time of report. Ataxia, Dysarthria. The discharge summary states ataxia, dysarthria, paraparesis, and conversion disorder. The discharge summary states seizure disorder.				Y	Y				N	10/16/2001	10/17/2001	1		OTH	PVT	Pain medication		Heart condition, breast cyst, allergy			1						1	Asthenia; Conversion disorder; Convulsion; Coordination abnormal; Dysarthria; Myalgia; Paralysis; Syncope	FLU3~EVANS VACCINES~E0523IKA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0177701	11/15/2001	PA	63.0	63		F	11/08/2001	A report was received from a health professional on 11/1/01, concerning a 63 year old female pt who experienced cellulitis, 2 days after receiving the FluVirin vaccine on 10/30/01. On 11/1/01, the pt experienced cellulitis of the entire right arm. The FluVirin was given in the right deltoid muscle. Therapeutic measures taken as a result of this event included Clindamycin and Diphenhydramine. The pt had not recovered at the time of this report. The reporter has assessed the relationship of the study medication to the event as possible. This was considered an Other Important Medical Event.				Y					N	10/30/2001	11/01/2001	2		OTH	OTH	Topical estrogen patch, Clindamycin		Hysterectomy, osteoarthritis, hypertension		PJP2001003540	1						1	Cellulitis; Injection site reaction	FLU3~EVANS VACCINES~E06741LA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0177702	11/15/2001		72.0	72		M	11/08/2001	On 11/1/01, pt experienced cellulitis of the entire right arm. Therapeutic measures taken as a result of this event included prescription of clindamycin and Diphenhydramine. The pt had not recovered at the time of report. The reporter has assessed the relationship of the study medication to the event as possible.				Y					N	10/30/2001	11/01/2001	2		OTH	OTH	Lupron, Pepcid	Malignant neoplasm of prostate			FJP2001003550	1						1	Cellulitis	FLU3~EVANS VACCINES~E0674ILA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0177728	11/15/2001	CA	55.0	55		M	10/31/2001	USAF officer experienced dysphoria and dizziness 15 min after Flu shot. 20 year history receiving same, no problems. Resolved within hours. No problems.									Y	10/30/2001	10/30/2001	0	NONE	PUB	MIL	NONE	NONE	NONE			1						1	Dizziness; Dysphoria	FLU3~SANOFI PASTEUR~U0674AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177729	11/15/2001	CT	49.0	49		F	11/05/2001	Severe arm edema 8 by 6, red, hot to touch, irritation at injection site above, symptoms lasted 6 days.									Y	10/31/2001	11/01/2001	1		PVT	PVT	NONE	NONE	Sulfa, PCN, Codeine, E-Mycin			1						1	Erythema; Feeling hot; Oedema; Skin irritation	FLU3~SANOFI PASTEUR~EOH341LA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177730	11/15/2001	CA	30.0	40		F	11/05/2001	Flu Shot received left deltoid 10/31/2001. Spot Bandaid applied to site. Client returned to HC 11/02/2001 c/o redness, local pruritis, chest tightness has history of multiple allergies. Hydrocortisone cream to area and ice, need to see PMD ASAP.									Y	10/31/2001	11/01/2001	1		OTH	UNK		NONE	Allergy: sulfa, dust/molds, pollens and animals.			1						1	Chest discomfort; Injection site erythema; Pruritus	FLU3~SANOFI PASTEUR~UO594AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177731	11/15/2001	TX	67.0	67		F	10/26/2001	10/26/2001 On day Following vaccine admin., client came to office stating that about 2 hour after injection was given, her left arm got swollen, red and very painful. She still had minimal swelling and slight redness at time. 10/30/2001 Phone call to pt who states that she's been pain free since Friday 10/26/2001 PM after she applied warm packs to arm, has very little swelling yet though no redness.									Y	10/25/2001	10/25/2001	0		PUB	PUB	Synthroid, Zocor and Metropolol	High cholestrol, HTN and Hypothyroid	Iodine and perfume		TX01164	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~UO588A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~469133~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0177732	11/15/2001	AL	54.0	54		F	10/29/2001	On 12/27/2001 between 3 and 4 PM, PT started feeling cold and feverish, had chills and elevated temperature, had bad headache (history of migraines given). States all joints ached. Skin felt sore. Had large area of erythema, soreness and warmth at injection site. Took OTC Tylenol and Benadryl 25mg.									Y	10/26/2001	10/27/2001	1	NONE	PUB	PUB	Premarin, Zyrtec, Celebrex, Zanaflex, Effenor, Neurotin, Solatron, Excedrin PM	NONE	Fibromyalgia, Arthritis, allergies to dust, tree pollen and grass pollen.		AL0113	1						1	Chills; Erythema; Feeling hot; Headache; Pain; Pyrexia	FLU3~EVANS VACCINES~E00941EK~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1448K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177733	11/15/2001	IN	45.0	45		F	11/06/2001	Nausea, vomiting and urticarial pruritic rash on hands, legs and thorax and face. Lip swelling and erythema but no pharygial or airway obstruction.										11/01/2001	11/04/2001	3	Frequent F/U no labs	PVT	PVT	Fosamax 70 mg weekly and Premarin 0.3 mg daily	NONE	Osteoporosis and estrogen replacement therapy			1						1	Erythema; Face oedema; Nausea; Rash pruritic; Urticaria; Vomiting	FLU3~EVANS VACCINES~E02781HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0177734	11/15/2001	WI	63.0	63		M	11/08/2001	Left arm pain, primary elbow to wrist less 24 hours after injection.				Y					U	11/07/2001	11/08/2001	1	Also received B12 injection in same arm.	PVT	UNK			PCN			1						1	Pain	FLU3~SANOFI PASTEUR~UO692AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177735	11/15/2001	PA	15.0	15		F	11/07/2001	Pt had paresthesia in right forearm, right calf, as well as right hand and foot. Began 5 minutes after injection and has progressively improved over the last 48 hours.				Y					Y	11/05/2001	11/05/2001	0		PVT	OTH	Ventolin	NONE	allergy to penicillins, cephlosporins, and seasonal			1						1	Paraesthesia	FLU3~SANOFI PASTEUR~U0680AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177736	11/15/2001	PA	36.0	36		M	11/02/2001	Left arm four inches below injection site became red, warm, and sore to touch. No fever and no swelling. The reaction started approximately 8 hours post injection and peaked 24 hours after shot. Within 96 hours arm is back to normal.										10/29/2001	10/29/2001	0		UNK	UNK						1						1	Erythema; Feeling hot; Pain	FLU3~SANOFI PASTEUR~UO677AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177737	11/15/2001	PA	33.0	33		F	11/02/2001	Employee received vaccine around 10 AM. Did not notice anything wrong until following AM when looked at upper arm red 4 inches below injection site and warm. No swelling. Observed area next 4 days and each day reaction decreased until normal on Friday 11/02/2001.									Y	10/29/2001	10/30/2001	1		UNK	UNK						1						1	Erythema	FLU3~SANOFI PASTEUR~UO677AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177738	11/15/2001	UT	27.0	27		M	11/08/2001	C/O R arm feeling numb and tingling, B/P 140/82 - c/o body feeling heavy, dizziness and nausea - evaluated by paramedics @ site. Symptoms resolved 6 hrs later, returned to work took Ibuprofen.				Y					Y	11/06/2001	11/06/2001	0		OTH	OTH	Zoloft	NONE	Allergy: erythromycin - Rx for depression			1						1	Blood pressure increased; Dizziness; Hypoaesthesia; Nausea; Sensation of heaviness	FLU3~EVANS VACCINES~E08791LA~5~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0177739	11/15/2001	UT	38.0	38		F	11/08/2001	Pt had drowsiness, headache, numbness of injection site. Moderate shortness of breath started 1 hour after immunization, duration 21/2 hours. Flovent inhaler and rest and Tylenol.									Y	11/07/2001	11/07/2001	0		OTH	OTH	Proventil inhaler	NONE	Asthma			1						1	Dyspnoea; Headache; Hypoaesthesia; Somnolence	FLU3~EVANS VACCINES~E08791LA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0177740	11/15/2001	TX	3.9	3		M	11/08/2001	11/05/2001 In for rev. post nasal drip and atopic dermatitis. Diagnosis/Impression: atopic child well clinically AD. Given flu vaccine after seen by MD. Mother later called from restaurant, had hives. Benadryl given. Hives had cleared by time they returned to office. Had eaten no new food, on no medications.				Y					Y	11/05/2001	11/05/2001	0		PVT	PVT		Atopic dermatitis	NKDA/atopic child			1						1	Dermatitis atopic; Postnasal drip; Urticaria	FLU3~SANOFI PASTEUR~UO599BA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177741	11/15/2001	WI	74.0	74		F	10/23/2001	Pt developed morbilliform macular papular rash onset 24 hrs after Influenza vaccine. Treated with Benadryl.									Y	10/22/2001	10/23/2001	1		PVT	OTH		NONE	HTN, treated for  bronchitis 9/21/01 with TMP/SMZ for 10 days			1						1	Rash morbilliform	FLU3~SANOFI PASTEUR~U0670AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177742	11/15/2001	IL	33.0	33		M	11/05/2001	Generalized itching to upper chest, rash present.									Y	10/31/2001	10/31/2001	0		OTH	MIL		NONE	NONE			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~UO686AB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~U0386AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0177743	11/15/2001	NJ	47.0	47		F	11/07/2001	Fever to 101 marked myalgia low back pain.				Y					Y	10/30/2001	10/31/2001	1	Labs done in ER - and do not have results.	PUB	PUB	NONE	NONE	Chronic hepatitis C-controlled.			1						1	Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U0597AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177744	11/15/2001	AZ	69.0	69		F	11/07/2001	Fever times 7 days after administration of vaccine; arm red - lasted L48 degree.									Y	10/26/2001	10/27/2001	1		PVT	PVT						1						1	Injection site erythema; Pyrexia	FLU3~SANOFI PASTEUR~UG688AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177745	11/15/2001	MA	28.0	28		F	11/06/2001	Administered FluVac 0.5 ml IM. Within 2-4 minutes lost consciousness, stopped breathing, immediate administrative of .3 cc epinephrine. Transported to Hosp by Ambulance cl recovered. Without further treatment and returned home 11/01/2001.				Y					Y	11/01/2001	11/02/2001	1		OTH	OTH	NONE		Exercise induced Asthma.			1						1	Apnoea; Loss of consciousness	FLU3~SANOFI PASTEUR~U0571AD~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177747	11/15/2001	VA	11.0	11		M	11/08/2001	Pt developed erythema, induration, and pain right upper arm at site of injection. Site of erythema is 10 X 12 cm. Injection was given on 11/5/01 and pt developed symptoms on 11/07/01. Also had a fever to 101 F. Expect complete recovery. Pt treated with antibiotics for presumed cellulitis.				Y					Y	11/05/2001	11/07/2001	2	CBC done. (I can't understand what the numbers given mean) but here goes: 14>13>288 80P11 L                                                                                                                       ------- --                                                                                                                                          38	MIL	MIL	Advair		asthma, eczema, allergic to molds			1						1	Cellulitis; Infection; Injection site erythema; Injection site induration; Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~U0674AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1197K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0177748	11/15/2001	NY	70.0	70		F	11/05/2001	Approximately 5 minutes after receiving vaccine, pt felt like passing out and c/o of involuntary shaking and numbness-decreased speech from numbness noted. Red area noticed around the base of throat and upper chest. No c/o SOB or dyspnea. Pt lay down on cot and BP taken. Transferred to ER. Called pt at home at 2:45 PM. Pt nervous and anxious, states she had no breakfast. Had some sips of water and resting. Husband with her. Felt better, set up on cot again felt like passing out and face was flushed. She was given Motrin, Benadryl, and epinephrine but is doing fine. to call if noticed anything at all happening. Not to get any more flu shots. Pt stated she had felt a rush when she had received former flu shots.									Y	11/05/2001	11/05/2001	0		PUB	PUB	tenormin, aldactazide,	NONE	Allergy to Plavix and Pen V			1						1	Erythema; Hypoaesthesia; Nervousness; Speech disorder; Syncope; Tremor	FLU3~SANOFI PASTEUR~U0670AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177749	11/15/2001	NH	70.0			F	11/06/2001	pt had tongue and facial swelling and hives. Was prescribed Prednisone by another MD.				Y					Y	10/25/2001	10/26/2001	1	NONE	PVT	PVT		NONE	Hypertension			1						1	Swelling face; Tongue oedema; Urticaria	FLU3~SANOFI PASTEUR~U0693AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177750	11/15/2001	WA	59.0	59		F	11/05/2001	Pt had fever of 100.3 10 hrs after injection. Hives(swollen red spots size of quarter or half dollar) 24 hrs after injection. Racing heart beat and general discomfort.  Muscles aches 10 hrs after injection.				Y					Y	11/04/2001	11/04/2001	0	NONE	OTH	PVT	Levoxyl	NONE	NONE			1						1	Discomfort; Heart rate increased; Myalgia; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0177751	11/15/2001	IN	54.0	54		F	11/06/2001	On 10/31/01 very sore arm, swelling lymph nodes. On 11/01/01 large hives, continued swelling and swelling and soreness. On 11/02/01 Dr appt and he prescribed Benadryl, cold packs. On 11/03/01 symptoms gone.				Y					Y	10/30/2001	10/31/2001	1		OTH	OTH	Synthroid, Relafen	NONE	NONE			1						1	Injection site pain; Lymphadenopathy; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0177752	11/15/2001	MD	5.0	5		M	11/01/2001	Received fluvax on 10/31/01, child returned home from school on 11/1/01 stating left arm had been itching at school all day. Left deltoid was reddened, itching, and warm to touch. Advised pt to apply cool compress to site, and Benadryl as needed.									Y	10/31/2001	11/01/2001	1	NONE	PVT	OTH	Albuterol, Intal, Flovent	Asthma	NKDA			1						1	Injection site erythema; Injection site hypersensitivity; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U0682AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177753	11/15/2001	HI	27.0	27		F	11/02/2001	Presented 12 post vaccination with symptoms of fever, chills, nausea of 4 days duration, swollen neck glands for 2 days. Treated symptomatically with Tylenol and fluids. Returned 3 days later with persistent symptoms of fever, chills, neck and body aches, and swollen glands.				Y					Y	09/26/2001	10/04/2001	8	Influenza A/B antigen screen-negative and respiratory virus culture results pending. Rubeola antibody titer done on 8/13/01 and results 0.62-negative.	OTH	OTH	Albuterol, Claritin, Advair, Desogen	NONE	Asthma			1						1	Chills; Lymphadenopathy; Nausea; Neck pain; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U0543AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0896L~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0177754	11/15/2001	AZ	64.0	64		M	11/06/2001	Nausea followed by flu like symptoms.									Y	10/31/2001	10/31/2001	0	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Influenza like illness; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0177755	11/15/2001	DC	69.0	69		F	11/07/2001	Erythema noted at injection site. Rx Claritin 10 x 3-9 days with relief.									Y	10/29/2001				PVT	PVT		NONE				1						1	Injection site erythema	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177756	11/15/2001	KY	41.0	41		F		Swollen, red, and hot at injection site. No treatment. Injection at 10:00 and had a reaction at 16:00 on the day of injection.									Y	11/02/2001	11/02/2001	0	NONE	OTH	OTH	NONE	NONE	Latex allergy, depression, back problems, food allergies,			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U0676AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177757	11/15/2001	NH	52.0	52		F	11/13/2001	Post vax, the patient experienced a sore throat, rhinitis, a fever, and muscle and joint pain for 5 days. The injection site became sore, red and elevated for 24 hours once the cold symptoms were treated 6 days post vax.									Y	10/30/2001	11/05/2001	6		PUB	PUB	Cozaar, Norvasc and ASA	NONE	Angina and Hypertension		NH0123	1						1	Arthralgia; Injection site erythema; Injection site pain; Injection site swelling; Myalgia; Pharyngolaryngeal pain; Pyrexia; Rhinitis	FLU3~EVANS VACCINES~E00951HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0177758	11/15/2001	CA	24.0	24		F	10/29/2001	Post vax, the patient experienced facial flushing and palpitations.				Y					Y	10/29/2001	10/29/2001	0	NONE	PVT	UNK		NONE	NONE			1						1	Flushing; Palpitations	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0177759	11/15/2001	CA	51.0	51		F		The patient complained of dizziness, nausea and not thinking clearly within 24 hours of receiving the flu vaccination. The patient denies a fever, vomiting or loss of consciousness.									N	11/13/2001	11/14/2001	1		OTH	PUB	HCTZ and Lotensin	NONE	High blood pressure and a history of congestive heart failure.			1						1	Dizziness; Nausea; Thinking abnormal	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0177760	11/15/2001	TX	57.0	57		F	11/14/2001	After receiving the vaccination on 11/01/2001 the patient experienced redness, pain and swelling in the left upper arm. Then 2 or 3 days later the patient developed welts on her chest. When the patient returned to the Dr on 11/05/2001 she was diagnosed with shingles.									U	11/01/2001	11/03/2001	2	Shingle culture - positive	PVT	PVT	Inderal, Intal, Beconase, Premarin, Proventil, Atarax and Duratuss	Hypertension and DDD	Allergic to Sulfa, Biaxin and Donnatal. Hypertension, migraine, asthma, GERD and DDD.			1						1	Herpes zoster; Infection; Injection site hypersensitivity; Injection site oedema; Injection site pain; Laboratory test abnormal; Urticaria	FLU3~SANOFI PASTEUR~40679DA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~476952910Z~1~IM~LA~PNEUMO (PREVNAR)~1	USA		Influenza
0177705	11/16/2001	FL	71.0	71		M	11/07/2001	Pt expired at 11:30 AM on 11/3/01. Death certificate states cause of death as cardiopulmonary arrest due to congestive heart failure. Other significant conditions noted were endstage cardiomyopathy and IDDM.  Cause of Death as per Death Certificate was cardiopulmonary arrest.	Y	11/03/2001							N	10/31/2001	11/03/2001	3		PVT	PVT			End stage cardiomyopathy; chronic atrial fibrillation; IDDM; renal insufficiency			1						1	Cardiac failure congestive; Cardio-respiratory arrest	FLU3~EVANS VACCINES~E06221KA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0177708	11/16/2001		61.0	61		M	11/14/2001	The pt was institutionalized in a nursing home and received a Flurvirin injection on 11/5/01. The next evening, the pt complained of chest pain and right hand pain. He was given sublingual nitroglycerin with marginal relief and experienced increasing shortness of breath. Subsequently, the pt was transported to the hospital and was pronounced dead upon arrival on 11/6/01. The reporter stated that the pt may have experienced a massive myocardial infarction. The reporter has assessed the relationship of study medication to the event as unknown. Death certificate states cause of death to be coronary artery disease.	Y	11/06/2001							N	11/05/2001	11/06/2001	1		OTH	OTH	Aspirin; Cardura; Cardizem; Vasotec; Effexor; Imdur; Lopressor; Plavix; Prevacid;Trazadone; Nitroglycerin; Tylenol; Zantac	Hemiparesis due to CVA	CVA with hemiparesis; hypertension and coronary bypass surgery		PJP2001003870	1						1	Chest pain; Dyspnoea; Myocardial infarction; Pain	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0177725	11/16/2001	MA	47.0	47		F	11/07/2001	Pt developed severe hives, itching and redness all over body. She had hoarseness and fast heartbeat. Benadryl was administered after 8 hours.			Y						Y	10/16/2001	10/18/2001	2		PVT	PVT	Celexa, Motrin, Darvocet-N	NONE	Fibroids, headaches, high cholesterol			1						1	Dysphonia; Erythema; Heart rate increased; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0671CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0177795	11/16/2001	KY	46.0	40		F	11/09/2001	The patient states that every time she has gotten a flu vaccine since 1996 the same thing happens a few days later; the end of her nose gets red and swollen, one or two days later the skin has clear liquid beneath it which drips out and the skin comes off a couple of days later when she washes her face. The area stays raw and bleeds every time it is touched for up to 2 months before it finally heals. The dermatologist diagnosed the lesion as a brown recluse spider bite.				Y					Y	01/04/1996	01/04/1996	0		PUB	PUB			Allergic to outdoor molds, penicillin, rabbits, walnuts and nickle.			1						1	Erythema; Fluid retention; Haemorrhagic diathesis; Injection site inflammation; Injury; Nasal oedema; Skin exfoliation	FLU3~EVANS VACCINES~E2825HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0177796	11/16/2001	ME	54.0	54		M	10/15/2001	The patient has stomach cramps, diarrhea and sweats. The patient was treating this with Tums.									Y	10/02/2001	10/02/2001	0	NONE	OTH	OTH	Eye drops - FMC	NONE				1						1	Abdominal pain; Diarrhoea; Hyperhidrosis	FLU3~SANOFI PASTEUR~U0599BA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177797	11/16/2001	MI	43.0	43		F	11/07/2001	The patient developed a rash.									U	11/01/2001	11/07/2001	6		PVT	UNK		NONE				1						1	Rash	FLU3~SANOFI PASTEUR~U0672AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177798	11/16/2001	NY	89.0	89		M	11/02/2001	On 10/08/2001 the patient complained of redness, swelling and a burning sensation in the muscle of the left arm. The patient was seen on 10/09/2001 and diagnosed with cellulitis. The patient was treated with Levaquin for 10 days.									Y	10/03/2001	10/08/2001	5	NONE	PVT	PVT	Prilosec, Paxil, Lasix, digoxin, ASA, KOVR, Axid, Amitriptyline and Procrit	NONE	CAD with CHF, anticoagulation, DJD, GERD, depression and PVD			1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Injection site reaction; Musculoskeletal discomfort	FLU3~SANOFI PASTEUR~V0669AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0946K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177799	11/16/2001	NY	77.0	77		M	11/02/2001	10/11/2001 the patient was seen at the Dr's office for tenderness and pain at the injection site with associated redness and swelling. The symptoms were noted within 2 hours after receiving the injection. The patient was treated with Levaquin for 5 days.									Y	10/09/2001	10/09/2001	0	NONE	PVT	PVT	Ambien, Nexium, ASA, Tricor, folic acid, Toprol XL, Arthripower and Mycelex.	Oral candidiasis	CAD, Hyperlipidemia and GERD			1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~V0669AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0946K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177801	11/16/2001	VT	48.0	48		F	11/09/2001	The patient felt dizzy, nauseated, nervous and was very pale. The patient rested and was reassured.									Y	11/09/2001	11/09/2001	0		OTH	PVT		NONE				1						1	Dizziness; Nausea; Nervousness; Pallor	FLU3~EVANS VACCINES~E10821LA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0177802	11/16/2001	NY	19.0	19		F	11/07/2001	Twenty minutes after receiving the flu shot the patient got hives all over her body, itched, her lips and tongue were swollen and she was very shaky. She did not have any shortness of breath or wheezing.									Y	11/02/2001	11/02/2001	0		PVT	UNK		NONE	NONE			1						1	Pruritus; Swelling face; Tongue oedema; Tremor; Urticaria	FLU3~SANOFI PASTEUR~U0693AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177803	11/16/2001	NY	31.0	31		F	11/06/2001	Post vax the patient developed a red area at the injection site, blotches over her body, a headache, tight chest and shaking.				Y					Y	10/31/2001	10/31/2001	0		PVT	UNK	Synthroid and Effexor	NONE	Allergic to Novacaine, Emycin, Amoxicllin, Augmentin, Zestril and Verapamil. Diagnosed with MUP, Hypothyroid and migraines.			1						1	Chest discomfort; Headache; Injection site erythema; Rash macular; Tremor	FLU3~SANOFI PASTEUR~U0598AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177804	11/16/2001	PA	52.0	52		F	11/08/2001	Within 6 hours after vaccinations the patient's left arm was warm, with severe pain and difficulty raising her arm. The patient was treated with heat and Tylenol.									Y	11/07/2001	11/07/2001	0		OTH	PVT						1						1	Injection site pain; Injection site warmth; Joint range of motion decreased	FLU3~EVANS VACCINES~E08341LA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0946K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177805	11/16/2001	IL	35.0	35		F	11/07/2001	11/05/2001 the patient was flushed. On 11/06/2001 the patient developed malaise, redness, warmth and a raised area of the right upper arm at the injection site. 11/07/2001 the patient feels better, has an area of redness 2 1/2x 1 1/2, slightly raised with warmth at the injection site. The patient was already on Voltaren and applied ice to site. 11/08/2001 the redness and pain had decreased.									Y	11/05/2001	11/05/2001	0	NONE	OTH	OTH	Avelide and Voltaren	NONE	Arm Problems			1						1	Flushing; Injection site erythema; Injection site swelling; Injection site warmth; Malaise	FLU3~SANOFI PASTEUR~U0696BA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177806	11/16/2001	CA	60.0	60		M	11/07/2001	The patient experienced fatigue, dizziness, muscle aches in the legs and chest, nausea, night sweats, loss of appetite, loss of weight and stomach cramps.									Y	11/01/2001	11/02/2001	1	NONE	OTH	PVT	Lipitor and glucophage	NONE	Diabetes Type 2			1						1	Abdominal pain; Anorexia; Dizziness; Fatigue; Myalgia; Nausea; Night sweats; Weight decreased	FLU3~SANOFI PASTEUR~U0592AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177807	11/16/2001	MD	56.0	56		F	11/12/2001	The patient's legs felt numb, tingling and weak. The patient's tongue was tingling, she had back pain and her blood pressure was up.				Y					Y	11/09/2001	11/09/2001	0	CT Scan	PUB	PVT						1						1	Back pain; Blood pressure increased; Muscular weakness; Paraesthesia; Tongue disorder	FLU3~PFIZER\WYETH~4018033~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0177808	11/16/2001	TN	78.0	78		F	11/07/2001	The patient's left arm had a circular, raised, erythematous patch of skin approximately 5 in diameter just below the site of injection on the left arm. The area was slightly warm to the touch. The patient was treated with Tylenol and Benadryl. The patient's symptoms resolved after 3 to 4 days.									Y	10/30/2001	10/31/2001	1		OTH	PVT	Lozol, Pravachol, Synthroid, and Advil.	NONE				1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U0691AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0995L~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177809	11/16/2001	PA	63.0	63		F	11/12/2001	The patient experienced erythema, swelling, and warmth of the entire right arm within 24 hours after receiving the vaccine. This was consistent with cellulitis. The patient was treated with Clindamycin and Benadryl.				Y					Y	10/30/2001	10/31/2001	1	NONE	PVT	UNK		NONE	Allergic to penicillin. Has osteoarthritis.			1						1	Cellulitis; Feeling hot; Oedema peripheral; Rash	FLU3~EVANS VACCINES~E06741LA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0177810	11/16/2001	PA	72.0	72		M	11/12/2001	The patient experienced erythema, swelling, and warmth of the left upper extremity within 24 hours of vaccination. The symptoms were cellulitis in nature. The patient was treated with Ceflex and Benadryl.				Y					Y	10/30/2001	10/31/2001	1	NONE	PVT	UNK		NONE				1						1	Cellulitis; Feeling hot; Oedema peripheral; Rash	FLU3~EVANS VACCINES~E06741LA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0177811	11/16/2001	MO	49.0	49		M	11/13/2001	One week post vax, the patient experienced moderate shoulder pain. The patient had a normal clinical exam.									Y	10/31/2001	11/07/2001	7		OTH	PVT	NONE	NONE	NONE			1						1	Shoulder pain	FLU3~SANOFI PASTEUR~U0668AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177812	11/16/2001	IL	50.0	50		F	11/19/2001	Post vax the patient developed a raised bump on his arm about the size of an egg in circumference. His skin felt leathery with a slight itch and redness.									Y	11/07/2001	11/08/2001	1		UNK	UNK						1						1	Dry skin; Erythema; Injection site mass; Pruritus	FLU3~SANOFI PASTEUR~U0594AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177813	11/16/2001	FL	69.0	69		F	11/01/2001	The patient complained of swelling and redness of her arm. The patient applied ice. The patient also complained of electric shocks down her arm. The patient's spouse left a message on the clinic's answering machine.									Y	10/30/2001	10/30/2001	0		PVT	OTH	Premarin, Allegra and Nasonex		Allergic to morphine.			1						1	Injection site erythema; Injection site swelling; Paraesthesia	FLU3~SANOFI PASTEUR~U0600AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177814	11/16/2001	GA	35.0			F	11/08/2001	The day after the vaccination the patient woke up with aches and a rash. The patient was treated with Benadryl.									Y	11/06/2001	11/07/2001	1	NONE	UNK	UNK	Seroquel, Lithium, Wellbutrin and Ambien		Allergic to penicillin, ASA, theophyline and PPD.			1						1	Pain; Rash	FLU3~EVANS VACCINES~U0595AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0177815	11/16/2001	MA	45.0	45		F	10/31/2001	The patient experienced swelling at the injection site, redness and hot to touch. The patient had a fever, swollen glands, body aches and chills. The patient was diagnosed with left nasal turbinitis, erythema, left submandibular adenitis, right submandibular adenitis, lung sounds (rales at bases); a nonproductive cough. Still treating.				Y					N	10/29/2001	10/29/2001	0	Chest x-ray, CBC, Sed rate	PVT	PVT	Paxil and Tylenol.		Positive for Hepatitis C - treated in 2000.			1						1	Cough; Erythema; Injection site swelling; Injection site warmth; Lymphadenopathy; Pain; Pyrexia; Rales; Rhinitis	FLU3~SANOFI PASTEUR~U0668AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177816	11/16/2001	CA	56.0	56		F	11/07/2001	Three weeks post vax, the patient's upper left arm aches and is sore.									N	10/17/2001	10/20/2001	3		PUB	PVT	Prempro	NONE	NONE			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U0588AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177817	11/16/2001	IL	30.0	30		F	10/30/2001	The patient experienced a rash, fever, severe muscle aches, sore throat, weakness and was unusually nervous. The patient had a fever, pain and high blood pressure when she was seen in the ER. The patient's temperature started at 2:00 am on 10/25/2001 and ranged from 100.6F to 102.6F and finally broke on 10/29/2001 around noon. The rash was lighter in color on Thursday and Friday after the patient began taking Benadryl. The patient was off work on Friday because she was too weak to move. When seen in the ER, the patient tested negative for strep, but the physician advised not to rule out a strep infection because the rash did not itch. Benadryl did not help the rash. The patient was on antibiotics for 4 days and the rash is disappearing.				Y					Y	10/24/2001	10/25/2001	1		PUB	PUB	Celexa, Xanax and Trazadone.	UNK	Depression			1						1	Asthenia; Hypertension; Myalgia; Nervousness; Pain; Pharyngolaryngeal pain; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0177818	11/16/2001	AL	76.0	76		F		The patient developed a reddened area at the injection site two days after the vaccination.				Y					U	10/03/2001				PVT	UNK		NONE	Lipid, NIDDM, CHF.			1						1	Injection site hypersensitivity	FLU3~SANOFI PASTEUR~U0668AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~474937~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0177820	11/16/2001		3.0			U	11/14/2001	A 3-year-old was inadvertently given FluShield vaccine under the deltoid muscles, which was supposed to be given in the deltoid muscle. The area below the deltoid muscle became red and hot with a large induration on the day following the vaccination.									U	11/06/2001	11/07/2001	1		UNK	UNK						1						1	Injection site erythema; Injection site induration	FLU3~PFIZER\WYETH~4018028~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0177821	11/16/2001	NY	46.0	46		F	11/12/2001	Post vax the patient had a red raised area at the site of injection and red-swelling lesion on her arm.									Y	11/07/2001	11/09/2001	2		PUB	PVT		NONE	NONE			1						1	Injection site hypersensitivity; Injection site swelling; Oedema peripheral; Rash erythematous	FLU3~PFIZER\WYETH~4018028~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0177822	11/16/2001	NY	68.0	68		F	11/09/2001	Post vax the patient experienced extreme dizziness when she lifted her head, her eyes flickered back and forth for 2 days and then she developed high blood pressure (165/95) was (199/110) and temperature was 100F. The patient is now being treated for high blood pressure with Hyzaar.				Y					Y	10/30/2001	10/31/2001	1	Blood tests all normal.	PUB	PUB	Hormone replacement.	NONE	NONE			1						1	Dizziness; Eye disorder; Hypertension; Pyrexia	FLU3~SANOFI PASTEUR~E009514A~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0945K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0177823	11/16/2001	MA	56.0	56		M	11/19/2001	The patient had bilateral neck pain radiating to his head. The Health Unit was called on 11/07/2001 and advised the patient to contact his own MD and to treat with Tylenol and Motrin.									U	10/31/2001	11/09/2001	9		OTH	PUB		NONE	Asthma, diabetes and allergic to penicillin.			1						1	Headache; Neck pain	FLU3~SANOFI PASTEUR~U0682AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177824	11/16/2001	VT	57.0	57		F	11/05/2001	The patient was injected with a needle on a syringe. There was no air or solution in it.									Y	11/05/2001				OTH	OTH		UNK	Allergic to Thimerosol.			1						1	Injury	FLU3~EVANS VACCINES~E10821LA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0177825	11/16/2001	MA	51.0	51		F	11/02/2001	The patient call and reported right ear pain and numbness in the right foot. The symptoms occured at approximately 6 PM on 11/01/2001. The ear pain passed by the AM of 11/02/2001. The patient states she also has TMJ. The patient's MD was called and advised the patient if she is not better by 11/05/2001 to see him, and if it is worse over the weekend to go to the ER.									U	11/01/2001	11/01/2001	0		OTH	PVT						1						1	Ear pain; Hypoaesthesia; Joint dislocation	FLU3~EVANS VACCINES~E08791LA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0995L~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177826	11/16/2001	MO	87.0	87		M	10/31/2001	The patient developed a rash around the injection site. 3 days later the patient noticed the rash had spread down his arm to his back, chest and to his right arm. The rash was solid on his right arm and neck and was scattered on all other areas. The patient experienced severe itching. The patient was seen by the doctor on 10/31/2001 and treated with a cortisone injection and medication for the itching.									N	10/23/2001	10/26/2001	3		PUB	PUB	Isosorbide, Metoprolol, Baby ASA and Rantidine.	NONE	High blood pressure.		MO2001057	1						1	Injection site rash; Rash pruritic	FLU3~SANOFI PASTEUR~U0590AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177827	11/16/2001	DE				F		The patient experienced a sore throat, difficulty swallowing, a minor headache, vomited once and a low grade fever.									U	11/08/2001	11/08/2001	0	NONE	OTH	PVT	NONE	NONE	Pregnant, 2nd trimester.			1						1	Dysphagia; Headache; Pharyngolaryngeal pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U0683AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177828	11/16/2001	WI	18.0	18		F	11/08/2001	The patient experienced a migraine headache, fever, stuffiness, felt hot and her head, neck and chest aches. The patient's right arm is sore at the site of injection. The patient had nausea and vomited on 11/06 and remained ill until 11/08.									Y	11/05/2001	11/05/2001	0	NONE	PVT	OTH		NONE	Allergic to penicillin.			1						1	Chest pain; Feeling hot; Injection site pain; Migraine; Nasal congestion; Nausea; Neck pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U0591EA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177829	11/16/2001	IA	50.0	50		F	11/15/2001	The patient called and came in with complaints of redness, swelling and pain in the bicep. This began around noon Friday. Symptoms were pretty much resolved by 11/05/2001. The patient treated with Benadryl and Ibuprofen to help resolve the pain and swelling.									Y	11/01/2001	11/02/2001	1		OTH	PVT	NONE	NONE	NONE			1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U0598AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1506L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177830	11/16/2001	MD	51.0	51		F	11/12/2001	The patient developed a 4cm x 7 cm erythema that was warm and slightly tender to touch.									N	11/11/2001	11/12/2001	1		OTH	PUB	Xanax					1						1	Feeling hot; Pain; Rash	FLU3~PFIZER\WYETH~4018032~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0177831	11/16/2001	MD	72.0	72		F	11/12/2001	On 11/05/2001 the patient experienced swelling, erythema and pain of the injection site. On 11/06/2001 the pain increased and the patient also had shortness of breath. The patient went to the ER and was diagnosed with an allergic reaction to influenza and cellulitis. Treatment for the cellulitis was initiated. The patient show improvement with Benadryl and NSAID's.				Y					Y	11/05/2001	11/05/2001	0	NONE	PVT	PVT	Accupril, Premarin, ASA, HCTZ and Lipitor.	NONE	Hypertension, hypercholesterolemia, hypothyroid, history CVA and GERD.			1						1	Cellulitis; Dyspnoea; Injection site erythema; Injection site pain; Injection site swelling	FLU3~EVANS VACCINES~E04811KA~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1051L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0177832	11/16/2001	AK	45.0	45		F	11/01/2001	At 11:40AM the patient experienced visual distortions in the left eye. She saw pulsing flashes of light whether her eyes were open or closed. The left side of whatever she looked at was obscured. The patient felt lightheaded and unsteady. The patient's blood pressure was elevated. Her vision cleared after 20 minutes. At 12:30PM the patient experienced tingling and numbness in her left hand, lips and nose. This subsided in 10 minutes. At 2:00PM the patient experienced chills, a slight fever, extreme malaise, slept 15 hours, had a sore arm and a headache.									Y	10/31/2001	10/31/2001	0		MIL	MIL	IPPD	NONE	NONE			1						1	Dizziness; Headache; Hypertension; Injection site pain; Malaise; Paraesthesia; Pyrexia; Somnolence; Visual disturbance	FLU3~SANOFI PASTEUR~U0674AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177833	11/16/2001	HI	67.0	66		M	11/07/2001	The patient experienced erythema and edema on his shoulder and neck adjacent to the injection site.				Y					Y	10/06/2001	10/07/2001	1		PVT	PVT	Meclizine, Nifedipine, Singular, Ambien, Allopurinol,  Prevacid, Ventolin, Zocor, ECASA and Viagra.	NONE	Hypertension, high cholesterol, cervical myelopathy, asthma, high uric acid, high triglycerides and allergic to Cephachlor and Vicoden.			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U0573AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1449K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0177834	11/16/2001	HI	66.0	66		F	11/06/2001	The patient experienced erythema and edema on the should and neck adjacent to the injection site.									Y	10/09/2001	10/09/2001	0		PVT	PVT	Lopid, Fosamax and Synthroid.	NONE	Hypertension, decreased thyroid, osteoporosis and diverticulosis.			1						1	Injection site oedema; Rash	FLU3~SANOFI PASTEUR~U0573AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1449K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177835	11/16/2001	NC	67.0			F	11/12/2001	On 10/17/2001 the patient complained of her left arm being red and swollen after taking the flu and pneumonia vaccines. The patient states she also ran a fever. The patient's arm was painful and tender. The patient was diagnosed with cellulitis. The patient was treated with Keflex and Diflucan.				Y					Y	10/15/2001	10/16/2001	1		OTH	UNK	Alleve	NONE	Arthritis of right hip.			1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~U0681AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1197K~2~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0177836	11/16/2001	OH	81.0	81		F	11/07/2001	Post vax, both of the patient's arms were red.									Y	10/31/2001	11/02/2001	2		PVT	OTH		NONE	EES, sulfa, HTN, hypothyroid and hyperglycemia.			1						1	Injection site hypersensitivity	FLU3~SANOFI PASTEUR~U0691AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0995L~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177837	11/16/2001	UT	48.0	48		F	11/13/2001	The patient received the vaccination on Monday. Her symptoms began on Tuesday. The patient experienced puffy, redness around the injection site. On Thursday the patient saw the Dr and was started on Prednisone and Atarax. Sunday was her worst day, with a rash covering nearly all of her body, but heaviest around the injection site. On Tuesday the patient saw the Dr and was prescribed Prednisone, Zyrtec and Atarax. 12/17/2001 Site has nodule remaining.				Y					Y	11/05/2001	11/06/2001	1		OTH	PVT	Fluoxetine, Glucophage, Glucotrol XL, Alprazolam, Furosemide, Lortab, Flexeril and Prednisone.		Diabetic and allergic to codeine, iracrolide, morphine and penicillin.			1						1	Injection site erythema; Injection site nodule; Injection site swelling; Rash	FLU3~SANOFI PASTEUR~U0598AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177895	11/19/2001	AL	69.0	68		M	11/15/2001	A consumer reported that her 69 year old father received Flu Shield vaccine ('00-'01) in 11/00. According to the daughter, in 12/00, her father couldn't get (his) heart in rhythm and it was racing. His health care provider cardioverted the pt X 2 and he also had a cardiac ablation procedure. He was hospitalized. No additional information was available as of the date of this report.				Y	Y				U	11/01/2000	12/01/2000	30	UNK	OTH	PVT	Amaryl; amiodarone hydrochloride; Coumadin; Prandin Kuhn; Vasotec	UNK	Cardiac failure congestive; Lung disorder NOS		HQ8336412NOV2001	1						1	Arrhythmia; Heart rate increased	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0177908	11/19/2001		53.0			M	11/13/2001	Pt was admitted to hospital with symptoms of congestive heart failure. Pt was normally in excellent health. Cardiologist's diagnosis was active viral myocarditis.					Y				U	10/19/2001	11/13/2001	25	ECHO: left ventricle markedly dilated with severe diffuse hypokinesia and an ejection fraction of less than 20%; blood cultures: neg; BUN/SCr: 19/2.0; left heart cath: left ventricular dysfunction with dilated cardiomyopathy	OTH	OTH			Kidney stones, penicillin allergy, hypertension			1						1	Blood creatinine increased; Cardiac disorder; Cardiac failure; Cardiac failure congestive; Cardiomyopathy; Myocarditis; Viral infection	FLU3~SANOFI PASTEUR~U0672AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0177912	11/19/2001	IA	72.0	72		M	11/08/2001	Pain, erytheme at injection site in right deltoid. One week later had fever, malaise and extremely weak.									Y	10/30/2001	11/06/2001	7	WBC 4.2 CXR-N1	PVT	PVT	NONE	NONE	Horse serum			1						1	Asthenia; Injection site erythema; Injection site pain; Malaise; Pyrexia	FLU3~SANOFI PASTEUR~UO672AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177913	11/19/2001	NE	50.0	50		F	11/06/2001	Sore, tender, painful left shoulder down to elbow.									U	10/25/2001	10/25/2001	0	NONE	PVT	PVT	Premerin 0.625mg	NONE	NONE			1						1	Pain	FLU3~SANOFI PASTEUR~U0590AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177914	11/19/2001	NJ	26.0	26		F	10/26/2001	Administered 0.5 mg Flu vaccine left deltoid at 10:20AM. AT 10:35AM pt alerted staff of flushing, swallowing strange and tongue curling. At 10:40AM Benadryl 25mg given. At 12:30PM pt reports resolution of symptoms, swallowing and tongue sensation. SL. residual groggy 2 hours Benadryl.									Y	10/25/2001	10/25/2001	0		OTH	OTH	NONE	NONE	NONE			1						1	Dysphagia; Flushing; Somnolence; Tongue disorder	FLU3~SANOFI PASTEUR~U0575AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177915	11/19/2001	NJ	30.0	30		F	10/26/2001	Employee Received Flu vaccine 10/23/2001 At 2pm, 0.5 mL IM left deltoid. Reported on 10/25/2001 that half hour after injection experienced upper lip and nose area tingling, slight numbness. Persisted for one hour. No treatment resolved.									Y	10/23/2001	10/23/2001	0		OTH	OTH	NONE	NONE	NONE			1						1	Hypoaesthesia; Paraesthesia	FLU3~SANOFI PASTEUR~U0575AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177916	11/19/2001	IL	52.0	52		F	11/16/2001	The day after the Flu shot, I experienced dizzy spells. These lasted 1.5 days.									Y	11/14/2001	11/15/2001	1		OTH	OTH		NONE	Allergic rhinitis, asthma and hypothyroidism.			1						1	Dizziness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0177917	11/19/2001	KY	39.0	39		F	11/16/2001	A knot the size of baseball, red, hot where the knot is.				Y					U	11/14/2001	11/15/2001	1		OTH	OTH	NONE	NONE				1						1	Erythema; Feeling hot	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0177918	11/19/2001	NY	50.0	50		F	11/07/2001	Within minutes of Flu vaccine c/o itching. Referred to internal medicine given Benadryl 15mg PO, within 10 minutes c/o throat closing, difficult to breath, given Epi 0.3 ml, no relief. Was referred to ER.									Y	11/01/2001	11/01/2001	0		PVT	UNK	Albuterol, Flovent, Prilosec, and Seravent.	NONE	E-mycin, Propulsid and local reaction to Flu vaccines.			1						1	Dyspnoea; Pruritus; Throat tightness	FLU3~SANOFI PASTEUR~UO693AA~5~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177921	11/19/2001	WY		77		M	11/16/2001	Left upper arm red, swollen ant warm to touch from deltoid to elbow. Temperature 97.5 then elevated to 100.5 for night shift, down with Tylenol 650mg PO. On 11/16/2001 still red with decrease of swelling, afebrile.									U	11/13/2001	11/14/2001	1	NONE	OTH	PVT		NONE	(Diamox-allergies) Alzheimer's, CAD, Osteoarthritis, peripheral edema, depression disorder non-psychotic.			1						1	Erythema; Feeling hot; Oedema; Pyrexia	FLU3~PFIZER\WYETH~4018033~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1159L~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177922	11/19/2001	NJ	67.0	67		F	11/12/2001	Received flu shot at 9:20AM and 11:45AM broke out in the hives on 10/24/2001. Hives lasted about 2.5 hours.				Y					Y	10/24/2001	10/24/2001	0		PUB	OTH	Niacin 1 week no previous reaction	NONE	Penicillin			1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0177923	11/19/2001	KY	44.0	44		F	11/11/2001	Large red spot. Warm to touch.									Y	11/08/2001	11/08/2001	0	NONE	PUB	UNK	NONE	NONE	Allergic to dust, cats, trees and pollen.			1						1	Erythema; Feeling hot	FLU3~SANOFI PASTEUR~UO67AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177924	11/19/2001	TX	35.0	35		M	11/13/2001	Vaccination done on 10/26/2001. Malaise and body aches started on 10/29/2001 afternoon. Fever on 10/29/2001 night. Responded to Motrin. Muscle aches slowly improving, but currently have scratchy throat. No fever in past 4-5 days.										10/26/2001	10/29/2001	3		PUB	PUB	NONE	NONE	Allergy to bee stings; Hepatitis A.			1						1	Malaise; Pain; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~UO692AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177925	11/19/2001	NY	35.0	34		F	11/09/2001	Hives begining evening of 11/02/2001, lasting thru 11/04/2001. Took Benadryl syrup to relieve itching. Total body, except head.									Y	11/02/2001	11/02/2001	0	NONE	OTH	PVT	NONE	NONE	Hay Fever type allergies			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~UO688AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177926	11/19/2001	IN	55.0	55		F	11/13/2001	Raised, red welt half way around arm. Very hot and sensitive in same area also in underarm.									Y	10/31/2001	11/01/2001	1		OTH	PVT	Synthroid, Premarin and Provera	NONE	Hypothyroidism			1						1	Feeling hot; Rash erythematous	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0177927	11/19/2001	AL	47.0	46		F	11/08/2001	Developed Swelling around injection site extending to an area of approximately 2.5 inches in circumference, pain at site, extending to left side of neck, left upper extremity tightness reported. Treatment: took OTC Benadryl.									Y	11/07/2001	11/07/2001	0		OTH	PVT	Premarin	NONE	NONE	local reaction~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~UO690AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177928	11/19/2001	NY	65.0	65		F	11/13/2001	Swollen, red and painful to touch area (upper arm). Hives on my upper right arm. This lasted for 2-3 days.									Y	10/23/2001	10/23/2001	0		OTH	OTH	Lopressor, Premarin, Progesterone, Hyzaar, Multi Vitamin and Calcium.	NONE				1						1	Erythema; Oedema; Pain; Urticaria	FLU3~EVANS VACCINES~E00951HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0526L~1~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177929	11/19/2001	VA	40.0	40		F	11/17/2001	Approximately 20 minutes after receiving the influenza injection on 11/06/2001, client reported that her hands, especially the palms, and her feet were itchy and that her hands seemed to be somewhat swollen, requiring her to remove her rings. RN informed her supervisor and telephoned the HD MD, who advised that this was a normal variation and that client should take 25mg of Benadryl when she gets home. About an hour later, around 4:05 PM, client reported to another nurse in Clinic that her bottom lip was itchy, slightly swollen and her tongue was tingling. This nurse consulted with the supervisor, who instructed her to promptly call MD for further guidance. MD advised client to take two 25 mg Benadryl immediately and go home, which client did. By the time the client arrived home, she was experiencing some difficulty swallowing along with some soreness in her throat and was beginning to have some difficulty breathing. Her husband accompanied her to the ER, where she received epinephrine with IV fluids, an injection of Benadryl and an oral dose of Prednisone. She was observed for an hour, her symptoms improved and she was discharged with a Prescription of Zantac and Claritin, as well as continued Prednisone. Client also reports that she has had some local redness, swelling and discomfort in the left deltoid area around the injection site.				Y					Y	11/06/2001	11/06/2001	0		PUB	PUB	Zantac, Atenol, Elmiron, Triametrine/HCTZ and Aspirin.	NONE	Allergic to preservative (DMSO) used in bladder wash; Asthma; Seasonal Allergies.		VA01031	1						1	Discomfort; Dysphagia; Dyspnoea; Injection site erythema; Injection site oedema; Oedema; Paraesthesia; Pharyngolaryngeal pain; Pruritus	FLU3~PFIZER\WYETH~4018028~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0177930	11/19/2001	MD	45.0	45		F	11/01/2001	Large 12cm diameter local reaction left upper extremity.				Y					Y	10/30/2001	10/30/2001	0		PVT	PUB		NONE	PCN, Thorazine, Sulfa			1						1	Application site reaction	FLU3~EVANS VACCINES~E08791LA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0177950	11/19/2001	KY	59.0	59		F	11/09/2001	Mid-afternoon, the day of the vaccination, the patient experienced swelling and tenderness of the glands under each ear and down the side of the throat towards the thyroid. The patient did not have a fever but by mid-afternoon the next day the patient had chills for about 3 hours.									Y	10/16/2001	10/16/2001	0		OTH	UNK	Metoprolol, Dilantin, Zestril, Prazosin, Lasix, Clonidine, Norvasc and Folic Acid.		Polycystic disease of the kidneys and liver, enlarged thyroid, also some seizure activity. Implanted pacemaker in 2000.	Flu like symptoms~Influenza (Seasonal) (no brand name)~1~19.00~In Patient		1						1	Chills; Lymph node pain; Lymphadenopathy	FLU3~SANOFI PASTEUR~U0574AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177952	11/19/2001	NJ	67.0	67		F	11/07/2001	The patient developed a rash on her face, ears, backside and arm. The patient was treated with Prednisone. On 11/12 the rash is better.				Y					N	10/26/2001	10/27/2001	1		PUB	PVT						1						1	Rash	FLU3~SANOFI PASTEUR~U0596AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0177955	11/20/2001	NY	44.0			M	11/16/2001	It was reported that a 44 year old white male was vaccinated in 1995 with a dose of pneumococcal vaccine 23 polyvalent and a dose of influenza virus vaccine. At the time of vaccination, the pt's CD4 count was 250 cells/microL (19%) and he was prescribed concomitantly zidovudine, lamivudine and sulfamethoxazole/trimethoprim. It was noted that over the subsequent 2 years, there was a transient increase of his CD4 count to a maximum of 370 cells/microL and then a slow decline. The pt presented in 4/97 to the ER with a 6 day history of violent shaking chills, night sweat and malaise. The pt reported shortness of breath, occasional blood-tinged sputum and pleuritic chest pain for 3 days. The pt was known to have been HIV (+) for 8 years, with risk factors including IV drug abuse. It was noted that the pt had received medical care at the infectious disease clinic at the same hospital. It was noted that at his last appointment, 3 months prior to his presentation to the ER, the pt had a CD4 cell count of 216 cells/microL (16%) and his viral load was 1270 copies/mL. It was reported that the pt completely recovered from a hepatitis b infection, but hat a history of chronic sinusitis and hepatitis C. The pt had never suffered from the opportunistic infections common in AIDS. It was reported that in the ER, the pt was poorly cooperative, appeared pale and coughed occasionally. He was afebrile, hypoxemic and had oliguria. Septic shock with severe bacterial pneumonia was dx'd. Ceftazidime, erythromycin, sulfamethoxazole/trimethoprim and IV hydration were administered. It was reported that the pt required orotracheal intubation and mechanical ventilation. About 11 hours after presenting to the ER, the pt developed recurrent ventricular tachycardia and expired. It was noted that with the exception of minimal aseptic leptomeningitis, the neuropathological findings were unremarkable. There was no evidence that the pt had a concurrent influenza infection. It was reported that Streptococcus pneumoniae was cultured from various blood samples. The organism was sensitive to penicillin, chloramphenicol, vancomycin and erythromycin. It was noted that the pneumococcal vaccine 23 polyvalent included isotype 3.	Y			Y	Y				N	01/01/1995	04/01/1997	821	RR-40/min; BP-91/60 mmHg; HR-114/min; breath sounds over his right lung field were decreased; CXR-showed an infiltrate of the entire right lung; Autopsy-showed lobar pneumonia, pleural effusion, ascites, cardiomegaly with unremarkable valves, esophageal varices, splenomegaly and hepatomegaly with liver cirrhosis. Histopathology of the lungs revealed sheets of acute and chronic inflammatory cells diffusely filling the alveolar spaces, intra-alveolar edema and capillary congestion. Histopathology of the liver revealed cirrhotic micronodules surrounded by bridging bands of fibrosis with portal ductular proliferation and moderately periductual lymphocytic infiltrate. Histopathology of the spleen showed marked sinusoidal congestion with mild depletion of the white pulp. Lymph nodes showed mild follicular depletion. Isotyping confirmed S. pneumonia, strain type 3.	OTH	OTH	lamivudine; sulfamethoxazole (+) zidovudine	Cirrhosis; human immunodeficiency virus antigen positive; hepatitis C; drug abuse	Chronic sinusitis; hepatitis B		WAES01110449	1						1	Ascites; Cardiomegaly; Chest pain; Chills; Dehydration; Dyspnoea; HIV test positive; Haemoptysis; Heart rate increased; Hepatic cirrhosis; Hepatomegaly; Hyperventilation; Hypotension; Hypoxia; Malaise; Meningitis; Night sweats; Oliguria; Pallor; Pleural effusion; Pneumonia; Sepsis; Splenomegaly; Varices oesophageal; Ventricular tachycardia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Results in Death	Influenza
0177979	11/20/2001	WV	69.0	69		F	11/12/2001	Marked swelling, warmth, edema shoulder to elbow.				Y					Y	11/06/2001	11/07/2001	1		PVT	PVT		NONE	Penicillin and codeine			1						1	Feeling hot; Oedema; Swelling	FLU3~EVANS VACCINES~E02781HA~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1052L~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0177983	11/20/2001	SC	76.0	76		F	11/08/2001	Local reaction treated with benadryl, cool compresses, cortisone cream.									Y	10/03/2001	10/04/2001	1	NONE	PVT	OTH	Synthroid, potassium, lasix, calcium, vit E, Premarin, aldomet, lorazepam, ASA, benadryl, dilacor, Norvasc, lopid,, Cazacr, allopurinol, desyrel	NONE				1						1	Injection site reaction	FLU3~SANOFI PASTEUR~U0682AA or U060~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177984	11/20/2001	SC	8.5	8		M		Local rash erythematous maculopapular on R deltoid near and around Pneumovax site which erupted immediately after shot was given and responded well to Zyrtex 10mg and singular 5mg, benadryl.									Y	11/14/2001	11/14/2001	0	NONE	PVT	OTH		Mild viral illness	Asthma, nasal allergies			1						1	Injection site erythema; Rash maculo-papular	FLU3~SANOFI PASTEUR~U0690AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~474936~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0177988	11/20/2001	ME				F	11/13/2001	Pt called, check out warm to touch, itching, red.									Y	11/06/2001	11/08/2001	2		OTH	PVT						1						1	Erythema; Pruritus	FLU3~SANOFI PASTEUR~U0682AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177989	11/20/2001	MI				F	11/13/2001	Swelling and tenderness around injection site. Approximately 2 1/2x3 1/2.									Y	11/05/2001	11/06/2001	1		OTH	PVT						1						1	Injection site oedema; Pain	FLU3~SANOFI PASTEUR~U0682AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177990	11/20/2001	MI				F	11/13/2001	Site bruised. Pt an Coumadin. No complaints.									Y	10/24/2001	10/24/2001	0		OTH	PVT	Caumadin					1						1	Ecchymosis	FLU3~SANOFI PASTEUR~U0682AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177991	11/20/2001	MI				F	11/13/2001	Pt complained of itching, Blotches on face and hands. Went into Church service. Over the counter Benadryl, Report OK by end of service.									Y	11/04/2001	11/04/2001	0		OTH	PVT		Denies				1						1	Hypersensitivity; Pruritus; Rash macular	FLU3~SANOFI PASTEUR~U0682AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177992	11/20/2001	TX	39.0	39		F	11/14/2001	The patient experienced gradually increasing erythema, pain and itching at the injection site. The area is 3.5cm x 5cm.									U	11/12/2001	11/12/2001	0	NONE	PVT	PVT	Prozac, Alese and Glucophage XR.	Diabetes	Diabetes and depression.			1						1	Injection site hypersensitivity; Injection site pain; Pruritus	FLU3~PFIZER\WYETH~4018033~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0177994	11/20/2001	FL	71.0	71		F	11/03/2001	Swollen has and red arm from just above right shoulder to just below elbow for one week.									Y	10/20/2001	10/21/2001	1		PUB	UNK		NONE	NONE			1						1	Erythema; Oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1187K~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0177997	11/20/2001	AK	68.0	68		M	11/09/2001	Pt received pneumococcal vaccine right deltoid on 11/06/2001. 11/08/2001 telephoned PHN, notes induration  (5 cm by 3 cm) erythema, warmth, tenderness, chills w/o fever. PHN referred to MD, diagnosed with cellulitis and placed on Keflex 500mg bid for 10 days. No prior reactions to vaccines.				Y					U	11/06/2001	11/07/2001	1	NONE	PUB	PUB		NONE	NONE			1						1	Cellulitis; Chills; Erythema; Feeling hot; Injection site induration; Tenderness	FLU3~SANOFI PASTEUR~UO573AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1449K~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0177998	11/20/2001	NY	36.0	36		F	11/15/2001	Generalized urticaria 3-4 hives after vaccine.									Y	11/06/2001	11/06/2001	0		UNK	PVT						1						1	Urticaria	FLU3~SANOFI PASTEUR~U0696BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0177999	11/20/2001	GA	58.0	58		F	11/13/2001	Taste of formaldehyde for two days. Extreme pain in neck. Could not lift or turn head. Strep throat.				Y					Y	10/18/2001	10/18/2001	0		OTH	OTH		NONE	NONE			1						1	Bacterial infection; Dysgeusia; Musculoskeletal stiffness; Neck pain	FLU3~SANOFI PASTEUR~UO595AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178002	11/20/2001	NY	19.0	19		M	11/08/2001	Fever 101.3, headache, dizziness, rapid pulse, stomach ache, felt cold.									Y	11/03/2001	11/03/2001	0		OTH	PVT	NONE	NONE				1						1	Abdominal pain; Dizziness; Feeling cold; Headache; Heart rate increased; Pyrexia	FLU3~SANOFI PASTEUR~UO685AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178003	11/20/2001	WI	54.0	54		F	11/12/2001	Flu vaccine given 11/09/2001 about noon. Sunday AM rash left ear, spread to back of neck, right ear and back of right hand, itching, burning. Treatment: Benadryl by mouth, rash stopped spreading, still there.									N	11/09/2001	11/11/2001	2		PVT	PVT	Atenolol and Tricor	NONE	Sulfa, CAD, high cholesterol, HTN, arthritis.			1						1	Rash pruritic	FLU3~SANOFI PASTEUR~UO575AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178004	11/20/2001	WI	26.0	26		F		Developed fever with left arm becoming red and swollen from injection site to elbow. Arm was also very painful. Injection, 11/01/2001, Symptoms 11/02/2001 PM which progressively worsened, urgent care clinic 11/05/2001, diagnosis Staph infection and placed on antibiotics.				Y					Y	11/01/2001	11/02/2001	1		PUB	PVT						1						1	Injection site erythema; Injection site swelling; Pyrexia	FLU3~SANOFI PASTEUR~U00682AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~2456K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0178005	11/20/2001	FL	33.0	33		F	11/13/2001	Following AM on waking, noticed reddened, hot, swollen, itchy area approximately 6x4 upper arm, around site of injection. Took Benadryl with ice to area. Resolved in 3 days.									Y	11/01/2001	11/02/2001	1		PVT	PVT	Lotrel, Selexa, Elavil, Noranth, Triliptal, Bus Par, Visceral.		Bipolar			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U0670AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178006	11/20/2001	MI	21.0	21		M	11/09/2001	Pt was given vaccination (Fluzore). In 10 minute pt was flushed skin warm to touch and slightly nauseous. Sat for 10 minutes and felt slightly better and wanted to leave. Returned in 1/2 hour still queasy and flushed. Administered Epipen. Felt better in 5 minutes. Pt remained better on 11/08/2001 as well.									Y	11/07/2001	11/07/2001	0		OTH	PVT	NONE	NONE	NONE			1						1	Flushing; Nausea	FLU3~SANOFI PASTEUR~U0618AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178007	11/20/2001	OR	77.0	77		F	11/12/2001	Rapid and irregular heartbeat after retiring approx 10pm - continuing through the night keeping me awake									Y	10/15/2001	10/15/2001	0		OTH	OTH						1						1	Tachyarrhythmia	FLU3~SANOFI PASTEUR~U0571AD~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178008	11/20/2001	DC	40.0	40		F	11/19/2001	In PM after flu shot, pt check out arm swelling and hives appearing called MD told her (according pt to apply hot/cold alternating, took Benadryl 1 hours h.s. next day arm (upper) very tender to touch. R t c/o rash at RN no see one, but saw small double scratch marks (scares of 3-4) Applied Hydro Cent cream.									Y	11/14/2001	11/14/2001	0		OTH	OTH	No Reg, PRN for asthma, Therapy/Premarin.					1						1	Swelling; Urticaria	FLU3~SANOFI PASTEUR~U0682AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178009	11/20/2001	NY	55.0	55		F	10/29/2001	Nauseous, headache, aches - arms and legs, fast heart beat, sore throat, slight cough. Symptoms from 10/25/2001, 12:00 noon. Thorough weekend and still have headache and some aches.10/28/2001, 1PM.									Y	10/25/2001	10/25/2001	0		OTH	OTH						1						1	Cough; Headache; Heart rate increased; Nausea; Pain; Pharyngolaryngeal pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178011	11/20/2001	NY	86.0	86		F	11/16/2001	Nausea, dizziness, chills, fever of 102 within 2 hours of receiving flu vaccination. Was prescribed Biaifin BID on 11/14/2001. Is improving. MD felt she had lung infection. Recovery - unable to see MD only spoke by telephone.									N	11/09/2001	11/10/2001	1		PUB	PVT	Imdur, Baby Aspirin Albuterol, Atrovent and Flovent.	Recovering from Bronchitis. Had been hospitalized.	Chronic bronchitis, past history TIAs. Allergy to Keflex.			1						1	Dizziness; Lung disorder; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0177293	11/21/2001	SC	53.0	53		F	11/13/2001	Left arm local cellulitis. Office visit-antibiotics.				Y					Y	10/11/2001	10/15/2001	4	Office Visit after injection	PVT	PVT		Cough, fever, local cellulitis left arm				1						2	Cellulitis; Cough; Injection site erythema; Injection site swelling; Injection site warmth; Pyrexia; Sinusitis; Cellulitis; Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1071K~1~IM~~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~071K~1~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0178034	11/21/2001	MA	70.0	70		M	11/15/2001	The pt received Influenza 0.5ml, IM, LA at approx. 12:45. At 14:31, he was found DOA in his car at a local plaza. The fire dept report states that the pt was found slumped behind the wheel of his car. Pt was found to be pulseless/apneic and clutching a NTG bottle in his left hand. The pt was cold, mottled with pooling in the face and arms. Estimated down time 1/2 to 1 hours, according shopkeeper (maybe longer) who noticed car in space for extended time. No trauma noted. Pupils fixed/dilated, pooling in face secondary to position. Pt leaning over steering wheel; neck, arms stiff. Rigor secondary to pt pooling line in hands/forearms, extended down time. Cold, pale/mottled, dry; obvious morbidity. COD as per death certificate -- cardiorepiratory arrest	Y	11/13/2001							N	11/13/2001	11/13/2001	0		PUB	OTH			History of by-pass surgery			1						1	Apnoea; Cardiac arrest; Chills; Livedo reticularis; Musculoskeletal stiffness; Mydriasis; Pulse absent	FLU3~SANOFI PASTEUR~U0676AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0178037	11/21/2001	NY	62.0	62		F	11/14/2001	On 11/9/01, received injection in left arm at 11:30. Approx. 1 hour later, arm was very red and swollen. Later, hives appeared in different areas of the body. Then fever, difficulty in breathing soon followed. Saw my PCP on 11/12/01 as an ER visit. Symptoms are starting to subside but breathing is still impaired. Hopefully making progress.			Y	Y					Y	11/09/2001	11/09/2001	0		OTH	OTH	Voltaren; Lipitor; arava, E-vista		RA			1						1	Dyspnoea; Injection site erythema; Injection site swelling; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U0703AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0178038	11/21/2001	ID	22.0	22		M	11/13/2001	Pt developed a mild rash on face, hours after shot. He broke out in hives, 24 to 36 hours later. Hives covered 60% of skin area. Went to ER and received treatment. Hives are slowly going away.			Y	Y					Y	11/08/2001	11/09/2001	1	Allergic to Demerol.	OTH	PVT	OTC sinus decongestant		NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U0688AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0178041	11/21/2001	OH	89.0	89		F	11/15/2001	The patient's granddaughter called on 11/14/2001 to report the patient has tingling in her fingers and legs and joint aches less than 24 hours after vaccination on 11/07/2001. By day 7 the condition had resolved except for the right index finger is still tingly and the left leg is weak and achey.									N	11/07/2001	11/08/2001	1	NONE	PUB	PUB		NONE	NONE			1						1	Arthralgia; Fatigue; Paraesthesia	FLU3~SANOFI PASTEUR~U0680AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178042	11/21/2001	IL	65.0	65		F	11/14/2001	The patient's reaction set in about 3 hours post vax. The patient experienced severe heart palpatations, nausea and general malaise. The patient was very sick for two full days.									Y	10/22/2001	10/22/2001	0		PVT	PVT		NONE				1						1	Malaise; Nausea; Palpitations	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178044	11/21/2001	IL	27.0	27		F	11/12/2001	The patient complained of tenderness at the left base of the neck, the left lateral chest wall and upper arm. After a medical exam, the patient was prescribed Darvocet N-100.				Y					Y	11/08/2001	11/09/2001	1		OTH	PVT		NONE				1						1	Chest pain; Injection site pain; Neck pain	FLU3~PFIZER\WYETH~4018028~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0178055	11/21/2001	ID	14.0	14		F	10/18/2001	The patient developed cellulitis of the left deltoid. The patient had redness and swelling of the injection site. The patient also experienced a headache and vomiting.				Y					U	10/05/2001	10/06/2001	1		PUB	PUB	Singulair and Albuterol MDI.		Asthma		ID01054	1						1	Cellulitis; Headache; Injection site hypersensitivity; Injection site oedema; Injection site reaction; Vomiting	FLU3~SANOFI PASTEUR~U0597AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~468422~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0178059	11/21/2001	ID	79.0	79		F	10/24/2001	The patient experienced urticaria, 4 x 3 at the site of injection.									Y	10/15/2001	10/16/2001	1		PVT	PUB	Accupril, Premarin and Fosamax.	NONE	Hypertension and osteoporosis.		ID01061	1						1	Injection site urticaria	FLU3~SANOFI PASTEUR~U0601AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~474936~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0178077	11/21/2001	NY	56.0	56		F	11/14/2001	On 11/12 post vax, the patient experienced aching pain in her legs, arms, back and collarbone. The patient took Tylenol. The patient called her MD, who feels the patient is reacting to the vaccine. On 11/14/2001 the patient feels better.									Y	11/12/2001	11/12/2001	0		PUB	PUB	MOBIC	NONE	Arthritis, asthma, allergic to penicillin, sulfa, erythromycin and ASA.			1						1	Pain	FLU3~SANOFI PASTEUR~U0683AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178085	11/21/2001	MS	41.0	41		F	11/14/2001	Pt developed pain, redness and swelling at the injection site and fever and myalgias.									Y	11/05/2001	11/06/2001	1	Mild anemia (chronic); Steroid induced diabetes of recent onset; elevated WBC which was felt to be secondary to steroids.	PVT	PVT	colchicine; Zantac; Effexor XR; Zyrtec; prednisone		Allergy to penicillin and sulfa; possible Behcet's Syndrome vs Lupus			1						1	Anaemia; Diabetes mellitus; Injection site erythema; Injection site pain; Injection site swelling; Myalgia; Pyrexia; White blood cell count increased	FLU3~SANOFI PASTEUR~U0598AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1449K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0178096	11/21/2001	NY	40.0	40		F	11/17/2001	Pt felt weak, nausea, dizziness 1/2 hour with vaccine. She ate a meal, vomited, then felt dizzy and weak. I had her lay down 1/2 hour. Pt felt better wanted to leave, she then started to walk. I accompanied her. She fainted second time. Discharged at 9 PM from ER with diagnosis of anemia and dehydration.				Y					Y	11/17/2001	11/17/2001	0		OTH	PVT	cough syrup antibiotic(unsure type)	2 weeks with surgical procedure. No known allergy.	History of anemia, hypertension.			1						1	Anaemia; Dehydration; Dizziness; Nausea	FLU3~SANOFI PASTEUR~U0699AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178097	11/21/2001	MI	49.0	49		F	11/07/2001	Symptoms: 10/26/2001 Woke up with aches and pain (all over) with sore throat.  No fever, lasted 3 days 3 days later developed, coughing, sore throat, hot and cold temperature 100 degree. No aches took OTC Tylenol/cold for 5 days. Saw MD 11/07/2001.				Y					Y	10/25/2001	10/26/2001	1		PUB	UNK	Tenormin, Dyazine, Lescol		Hypertension			1						1	Cough; Pain; Pharyngitis; Pyrexia; Chest pain; Cough; Pharyngitis; Pyrexia; Vasodilation procedure	FLU3~SANOFI PASTEUR~U0684AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~UO684AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0178098	11/21/2001	FL	31.0	31		M	11/06/2001	Shot administered 11/2/01, headache soon followed and lasted until 11/3/01 late evening rash broke out on 11/4/01, applied benadryl cream to site of rash and took benadryl allergy pills.									Y	11/02/2001	11/02/2001	0	NONE	OTH	OTH	MVI	NONE	allergy to cat dander			1						1	Headache; Rash	FLU3~EVANS VACCINES~E04921KA~1~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0178100	11/21/2001	NJ	64.0	64		M	11/18/2001	Pt check out itchiness of bilateral arms. Abdomen and back area. Pt also noticed small red rash on above areas. Pt took Benadryl 25 mg. by mouth.									N	11/12/2001	11/12/2001	0		PUB	PVT		NONE	Allergic to PCN, keflex with left ankle osteomyelitis.			1						1	Hypersensitivity; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178101	11/21/2001	AK	77.0	77		M	10/25/2001	Felt very hot, no perspiration, felt like he was burning up. Fast respiration, shivering, felt he was hallucinating. Felt weak the next day but otherwise normal. It was very scary. had felt chilled 10/22 in the evening.									Y	10/23/2001	10/23/2001	0	NONE	PUB	PUB	Xalatan drops	Felt chilled the night before	glaucoma, allergic to tomoptic drops		AK200169	1						1	Asthenia; Chills; Hallucination; Hot flush; Respiratory rate increased	FLU3~SANOFI PASTEUR~Uo573AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178106	11/21/2001	TX	69.0	68		F	11/09/2001	2 1/2 hours, post vax, I had chills lasting for several hours. The arm, from injection site to elbow, was hot, edematous and red. The MD saw area on Monday. Rx'd Biaxin 500mg BID X 10 days. The arm was very painful for 1 full week.				Y					Y	10/27/2001	10/27/2001	0		OTH	OTH	Zinc; Premarin; Protonix	NONE	NONE			1						1	Chills; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U0694AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1456K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0178107	11/21/2001	TX	25.0	25		M	11/08/2001	Ill feeling about 2 1/2 hours, post vax. Pain was noticed to the arm around 22:00. The next AM, noticed redness at the injection site of pneumococcal vaccine. States he also had a fever (generalized). Went to health dept to see nurse but did not wait as the clinic was busy. Saw someone at a walk-in clinic. He had a fever of 100.7F and was started on an antibiotic 1 BID X 10 pills. Feels a little better. Temperature is now 99F. Redness at the injection site, 4 1/2 X 2 1/2, warm and slightly raised. Told to call back if any questions or problems. Given clinic number and nurses name.				Y					Y	11/05/2001	11/05/2001	0	NONE	PUB	PUB	NONE	NONE	NONE		TX01173	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Malaise; Pyrexia	FLU3~SANOFI PASTEUR~U0692AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~474934~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0178108	11/21/2001	TX	48.0	48		F	11/02/2001	Pt developed slight discomfort at the site of injection the next day, worsening a little each day. More pain when she lays on the side. No redness or edema.									Y	10/29/2001	11/02/2001	4		PUB	PUB	Flonase; Nexium; Accolate; Estratest; Hydrocodone	NONE	Low platelets; Splenectomy on 8/21/01; Allergic to Phenergan		TX01168	1						1	Injection site pain	FLU3~SANOFI PASTEUR~U0682AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178109	11/21/2001	TX	58.0	58		F	11/05/2001	Per pt, she states that about 20 minutes, post vax, she had onset of pain (severe) to left arm which lasted through the night. Pain subsided by the AM, the next day (10/30/01). No pain today. Also had slight swelling which has subsided since she started using warm packs.									Y	10/29/2001	10/29/2001	0		PUB	PUB	Vasotec, daily		HTN; Allergic to PCN and ASA; No birth defects		TX01172	1						1	Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U0675AB~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178110	11/21/2001	DE	53.0	53		F	11/15/2001	At 03:00 AM, on 11/15/01, the pt noted hives and complained of itching on her face, neck and upper torso. Rx'd Claritin D 1 QD PO.									U	11/14/2001	11/15/2001	1		OTH	PVT	BCP's; Acitex	NONE	NONE			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0683BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178111	11/21/2001	IL	29.0	29		F	10/31/2001	Pt felt fine after receiving flu shot; raked leaves and took her usual evening nap but woke up to get ready for work and felt very weak and throat was dry. Upon arriving at work, she felt warm and her heart was racing (BP-117/90; Pulse-135 and irregular)  which is very unusual. Her legs felt rubbery and she was taken to the ER at 23:59, midnight. Her temperature was 101.6F, she was cool to touch and body was aching. She is recovering.				Y					U	10/30/2001	10/30/2001	0	BP was 117/90 and then 117/70; Pulse was 135 and irregular and then decreased to 100; O2 sats were 93%; Temperature was 101.6F and then 102.5F; UA-neg; Metabolic Panel-OK; CXR-Clear	OTH	PUB	Birth control pills	NONE	NONE		IL01048	1						1	Asthenia; Blood pressure increased; Dry throat; Feeling hot; Heart rate increased; Heart rate irregular; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U0602BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178113	11/21/2001	TX	30.0	30		M	11/13/2001	Pt's arm became hot and inflammed on the afternoon, post vax. A rash appeared shortly afterwards, becoming pustular and traveling down the entire left arm. Rash covered entire arm and was very inflammed and uncomfortable. Pt went to PCP on 10/22/01 and was given an injection of Kenalog and a Medrol Dosepak. At completion of Dosepak, all inflammation had disappeared but evidence of the rash still remains as of 11/13/01.				Y					Y	10/19/2001	10/19/2001	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site inflammation; Injection site pain; Injection site warmth; Rash pustular	FLU3~SANOFI PASTEUR~U0597AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178115	11/21/2001	CA	35.0	35		F	11/01/2001	24 hours post vax, the pt was plagued by extreme achiness, headache, very upset stomach, no fever for a duration of 48 hours.									Y	10/16/2001	10/17/2001	1	N/A	OTH	PVT	Depo Provera	NONE	Type II Diabetes			1						1	Headache; Pain; Stomach discomfort	FLU3~SANOFI PASTEUR~U0592AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178116	11/21/2001	CA	39.0	39		F	11/07/2001	Pt experienced diarrhea and fatigue for a duration of one day.									Y	10/16/2001	10/17/2001	1	N/A	OTH	PVT	Tri-Levlen	NONE	NONE			1						1	Diarrhoea; Fatigue	FLU3~SANOFI PASTEUR~U0592AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178117	11/21/2001	OH	54.0	54		F	11/15/2001	Pt received flu shot in right arm on 11/14/01, Pneumonia in left arm on the same day. Pt awoke early the next morning with pain and swelling of right upper arm. Pt presented to physician with 6 X 4 of redness and warmth. Treated with Epinephrine and Depomedrol.									Y	11/14/2001	11/15/2001	1		PVT	PVT	Verapamil; Aldactone, Avapro, Allegra		Htn, chronic hepatitis C; Allergies			1						1	Erythema; Feeling hot; Oedema; Pain	FLU3~SANOFI PASTEUR~40703AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1051L~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0178119	11/21/2001	IL	80.0	80		F	11/14/2001	Cellulitis of right arm.									Y	10/10/2001	10/11/2001	1		PVT	OTH	Lipitor; Fosamax; Tenormin; Flurinot; Zoloft		Previously resolved pneumonia			1						1	Cellulitis; Injection site reaction	FLU3~EVANS VACCINES~E02101HA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1071K~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0178120	11/21/2001	WA	20.0	20		F	11/06/2001	Received flu vaccine at 9 am on 11/02/01, 2 hours later started sneezing and became sinus congested. In another 3 hours she had itching eyes and than started to feel more and more body itching. Did not develop rash or have trouble breathing. Around 4PM took a Benadryl tablet and started to feel better. She reported this on 11/5/01 at which time she was feeling fine.									Y	11/02/2001	11/02/2001	0		PVT	PVT			Allergy - milk, wheat			1						1	Hypersensitivity; Pruritus; Rhinitis	FLU3~EVANS VACCINES~E04851KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0178121	11/21/2001	PA	30.0	30		F	11/15/2001	Intramural reaction diffuse pruritis.				Y					Y	10/22/2001	10/23/2001	1		PUB	PVT	Sere Vent, azconical, PPD(Tinc Test)	NONE	Asthma			1						1	Pruritus	FLU3~SANOFI PASTEUR~U0669AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1047L~4~IM~RA~HEP B (RECOMBIVAX HB)~1	USA	Emergency room visit	Influenza
0178122	11/21/2001	WA	16.0	16		F	11/14/2001	Oblong, irregular pink rash that appears below vaccine site. Tender with palpation. Discomfort at the site of redness. Diffuse ill defined pinkness on the left shoulder.									Y	11/02/2001	11/03/2001	1		OTH	PVT	Zorvax		Total Anomalous Venous Repair.			1						1	Injection site erythema; Pain; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178127	11/21/2001	IA	68.0	68		F	11/08/2001	Pt starts received flu and pneumonia vaccine in left arm 10/23/01. Later that day arm became painful, swollen and unable to raise arm. Seen by Dr. on 10-24-01. Prescribed 10d course of Cephalexin and Zyrtec. Pt has completed meds. Pt states swelling is down, gets out of breath, feels weak sometimes.				Y					N	10/23/2001	10/23/2001	0		PUB	PVT			Emphysema/COPD	~Tetanus Toxoid (no brand name)~1~30.00~Patient		1						1	Dyspnoea; Injection site oedema; Pain	FLU3~SANOFI PASTEUR~U0597AA63003~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0944K42802~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0178128	11/21/2001	AK	58.0	58		M	11/07/2001	One day post vax left upper arm became pink, swollen and warm to touch from shoulder to elbow. Treated with oral Benadryl and ice. Pt seen by ER physician to make sure it was not cellulitis. Pt continued to treat with oral Benadryl and swelling started to decrease. Six days post vax the pt is doing much better but still some swelling present.				Y					N	11/01/2001	11/02/2001	1	NONE	PUB	PUB		NONE	bronchitis, pneumonia, other respiratory problems		AK200170	1						1	Erythema; Feeling hot; Oedema peripheral	FLU3~SANOFI PASTEUR~U0680AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~474936~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0178131	11/21/2001	IL	46.0	46		F	11/13/2001	Localized erythema with induration 80 by 60 mm. Treated with Benadryl and Motrin.				Y					Y	11/07/2001	11/08/2001	1		PVT	PVT		NONE	NONE			1						1	Injection site erythema; Injection site hypersensitivity; Injection site induration	FLU3~SANOFI PASTEUR~UO591DA~5~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178133	11/21/2001	UT	39.0	39		F	11/13/2001	Rash and swelling at injection site.									Y	10/23/2001	10/24/2001	1		PUB	PVT	Prozac					1						1	Injection site hypersensitivity; Injection site oedema; Injection site rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178134	11/21/2001	MA	1.08	1	.1	M	11/14/2001	On 11/07/2001 pt developed fever for 3 days. On 11/09/2001-11/11/2001 developed rash, observe. Phone follow up 11/13/2001 doing okay.									Y	10/30/2001	11/07/2001	8		PVT	PUB		URI, vomit diarrhea for 3-4 days	Horseshoe kidney with hydronephrosis, Laryngotracheomolaria			1						1	Pyrexia; Rash	FLU3~SANOFI PASTEUR~UO571AD~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~T0908~3~~RL~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0584K~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0178137	11/21/2001	IL	48.0	48		F	11/12/2001	Pt complained of tenderness left neck base and tenderness chest wall lateral to left breast. No visible palpable changes at the injection site. Pt treated with Darvocet.				Y					Y	11/08/2001	11/09/2001	1		OTH	PVT		NONE				1						1	Tenderness	FLU3~PFIZER\WYETH~4018028~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0178138	11/21/2001	TX	4.0	4		M	11/15/2001	Itching and swelling at vaccine site 1 day after, resolved 1 day later.									Y	11/06/2001	11/06/2001	0	NONE	PVT	PVT		NONE	Asthma			1						1	Injection site oedema; Pruritus	FLU3~SANOFI PASTEUR~UO676AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178139	11/21/2001	MI	72.0	72		F	11/11/2001	Checked out redness swelling of arm down to elbow started 11/13/2001, only used cold packs.									Y	11/12/2001	11/13/2001	1		PVT	PVT	Lasix activase, norvasc, synthroid, enalapril		HTW hypot			1						1	Injection site oedema	FLU3~SANOFI PASTEUR~U0698AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0923L~UNK~SC~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0178140	11/21/2001	FL	63.0	62		M	11/02/2001	Subsequent to receiving vax, the pts right upper arm red from shoulder to elbow with no pain or swelling. The next day the redness subsided in the upper arm and went to lower arm with evidence of water under the skin (not blisters).Subsequently the pt recovered.				Y					Y	10/30/2001	10/30/2001	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U0679BA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0718L~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0178141	11/21/2001	CA				F	10/24/2001	Aching increased in left arm, encompassing entire arm, axilla times 2 day gradually diminished over 1 week.									Y	10/15/2001	10/15/2001	0		PUB	PVT			NKDA			1						1	Achlorhydria	FLU3~SANOFI PASTEUR~U0592AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178142	11/21/2001	NC	80.0	80		F	11/20/2001	A physician reported that a female in her late 80's received an injection of Flu Shield ('01-'02). On 11/12/01, approx. 5 to 7 days post vax, she developed a severe, blistering, maculopapular rash on the front and back of her trunk. She was treated with valacyclovir and steroids. On 11/18/01, she died. No further information was available at the date of this report. Death certificate states cause of death as vasculitis with other significant condition of stroke.	Y	11/18/2001		Y					N	11/07/2001	11/12/2001	5	UNK	PVT	OTH	Zoloft	UNK	Aphasia; Cardiovascular disorder NOS; Cerebrovascular accident NOS		HQ8617920NOV2001	1						1	Rash maculo-papular; Vasculitis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0178144	11/21/2001	CT	37.0	37		M	11/14/2001	Pt experienced vomiting, diarrhea, muscle and joint pain and weakness.									U	11/13/2001	11/13/2001	0	NONE	PUB	PVT	NONE	NONE	NONE			1						1	Arthralgia; Asthenia; Myalgia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178145	11/21/2001	NC	31.0	31		F	11/14/2001	One day post vax the pt developed 3 liquid filled blisters approximately the size of pencil erasers. The next week the pt developed acute bronchitis with flu-like symptoms. Was seen by physician.				Y					Y	10/23/2001	10/24/2001	1	NONE	OTH	PVT		NONE	NONE			1						1	Blister; Bronchitis acute; Influenza like illness	FLU3~SANOFI PASTEUR~U0681AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178146	11/21/2001	NC	27.0	27		F	11/14/2001	Two inch diameter big, red area on arm appeared 2 days after shot, felt lethargic, headache, stomach ache. Saw doctor that day on 10/24/2001.										10/22/2001	10/24/2001	2	NONE	OTH	PVT		NONE	NONE			1						1	Abdominal pain; Headache; Injection site erythema; Lethargy	FLU3~SANOFI PASTEUR~UO681AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178149	11/21/2001	CA	95.0	95		F	11/21/2001	Pt had been to PCP on 11/8/01 for a check-up and she was healthy, no medical problems and blood work was normal. She was found on 11/13/01 per housekeeper on the floor. MD signed the death certificate as atrial fib but said COD was either heart attach or CVA. No autopsy done. Actual death certificate states cause of death as ventricular fibrillation due to coronary artery disease.	Y	11/12/2001							N	11/10/2001	11/12/2001	2		OTH	PUB	NONE	NONE	NONE			1						1	Coronary artery disease; Ventricular fibrillation	FLUX~UNKNOWN MANUFACTURER~~7+~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0178724	11/23/2001	OH	77.0	77		M	11/23/2001	Pt developed Temperature 102, shook from head to toe. Pt felt was either from flu shot or related to previous heart condition. ER doctor felt pt had a virus and put on antibiotics. Pt recovered.				Y					Y	11/01/2001	11/01/2001	0	EKG and CXR - OK in. ER 11/01/01	PUB	PVT		NONE	Previous heart attack		OH0067	1						1	Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U0595AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178151	11/26/2001	OH	53.0	53		M	11/15/2001	It was reported that a 53 year old male pt received a Fluzone SV '01-'02 vaccination, lot U0S682AA, on 10/25/01. One week later, the pt experienced tingling of his fingers and legs, leg weakness and is currently being treated in the hospital by a physician.					Y				U	10/25/2001	11/01/2001	7		OTH	OTH					U2001011460	1						1	Muscular weakness; Paraesthesia	FLU3~SANOFI PASTEUR~U0682AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0178158	11/26/2001	NY	38.0	38		M	11/02/2001	About 1 1/2 days, post vax, I suffered a seizure.					Y				U	10/05/2001	10/06/2001	1	All tests (EDG, EEG, Cat Scan) were normal.	OTH	OTH	NONE		NONE			1						1	Convulsion	FLU3~EVANS VACCINES~E02741A1J~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0178167	11/26/2001	TX	31.0	31		F		Large nodule									Y	11/07/2001				PVT	OTH		Asthma, Allergic rhinitis				1						1	Injection site nodule	FLUX~UNKNOWN MANUFACTURER~U0677AA~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1l156K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0178168	11/26/2001	TX	67.0	67		M		Pt had goose eggs bump and sore nodule.									U	11/12/2001				PVT	OTH		Acute bronchitis				1						1	Injection site nodule; Injection site pain	FLUX~UNKNOWN MANUFACTURER~U0677AA~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1071K~UNK~SC~LL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0178169	11/26/2001	AK	41.0	41		F	11/01/2001	Pt had soreness in  injection site on 10/20/01, which resolved. On 10/20/01 she had an episode of nausea, severe diarrhea, right eye felt like it was paralyzed and reports it was swollen, and her heart rate was rapid and light. Approximately 1 hour after the episode of diarrhea, she reported feeling better and the swelling in her eye went away. She did not have any further episodes.									Y	10/19/2001	10/20/2001	1		PUB	PUB			Allergy to metronidazole		AK200168	1						1	Diarrhoea; Eye swelling; Heart rate increased; Injection site pain; Nausea; Ophthalmoplegia	FLU3~SANOFI PASTEUR~U0573AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178170	11/26/2001	UT	48.0	48		F	10/31/2001	Woke up at midnight with severe chills. Took warm bath and noticed entire right arm ached and right hand joints swollen. Began vomiting X 20. At 2:00 AM temp was 101 F. and right neck gland was swollen, right ear ached , and right eye lid was swollen. Chest felt heavy and shooting pains from right side across chest, 3:30 stomach settled . At 6:00 AM all symptoms  still present but very diminished. 11:00 AM some residual knuckle swelling, other signs and symptoms gone. No difficulty breathing. Slight tenderness at injection site at injection site on right deltoid. Called hospital at 3:00 AM-told it was flu shot.									Y	10/30/2001	10/31/2001	1	NONE	PUB	PVT	inhalers, levaquin	bladder infection	Asthma		UT010621	1						1	Chest pain; Chills; Ear pain; Eyelid oedema; Injection site pain; Joint swelling; Lymphadenopathy; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U0571AD~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178171	11/26/2001	UT	51.0	51		F	10/29/2001	From nursing notes in chart per K. Ellis-benign. FWP-C 10/25/2001 had yellow fever vaccine 24 hours ago; has 1 ? at sit of immunization. 3 cm x 2 cm solid red lesion in right upper SQ area. Area is warm to touch . Pt denies any egg, latex, gelatin and sorbital allergy. Tx with ice and antihistamine.									Y	10/24/2001	10/25/2001	1	NONE	PUB	PVT	NONE	NONE	NONE		UT010620	1						1	Injection site erythema; Skin ulcer	FLU3~SANOFI PASTEUR~U0571AD~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0244L~1~IM~RA~HEP A (VAQTA)~1|TYP~CONNAUGHT LABORATORIES~R1407~1~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|YF~CONNAUGHT LABORATORIES~B045AA~1~SC~RA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0178172	11/26/2001	MA	44.0	44		F	11/15/2001	Sore Arm at injection site(painful) and hand swollen . Swelling at site locally, then felt ill and chills 5 hrs after vaccine admin.									Y	11/14/2001	11/14/2001	0	NONE	PUB	PVT	Flovent	NONE	ASthma, bursitis, had hole in heart-repaired	Same~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Chills; Feeling abnormal; Injection site pain; Injection site swelling; Swelling	FLU3~SANOFI PASTEUR~U0671CA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178173	11/26/2001	NJ	19.0	19		F	10/25/2001	According to pt, her right arm is feeling sore. On 10/23 at 12 noon the pt complained of nausea, and temp of 100.3, diaphous?. The pt complained of 2 welts size of 5 cent piece, red and swollen and hot to touch. Right upper arm tender, pt alternate hot and cold compresses to site. PHN stressed cold compresses . Pt taking Tylenol and has appt with MD.				Y					N	10/22/2001	10/23/2001	1		PUB	PUB	Vitamins	NONE	Poison Ivy		NJ200123	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Nausea; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U059AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1449K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0178174	11/26/2001	CA	52.0	52		F	11/21/2001	Pt stated she felt hot, flushed rash and itching to arms, chest, torso, and face. Also a headache to left side of head only. No respiratory distress.				Y					Y	11/16/2001	11/16/2001	0	NONE	PVT	PVT	Flonase and Allegra	NONE	Basic allergies and history of exercise induced asthma			1						1	Headache; Hot flush; Pruritus; Rash	FLU3~SANOFI PASTEUR~U0601~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178175	11/26/2001	IL	60.0	60		F	11/21/2001	Pt felt sick to stomach, had a bad headache. Went to bed during this time and face at one point felt like it was on fire from the inside out. Felt bad next day.									Y	10/09/2001	10/09/2001	0		OTH	OTH	Tenormin, Zocor, Prinivil	NONE				1						1	Headache; Nausea; Skin warm	FLU3~SANOFI PASTEUR~U0575AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178176	11/26/2001	MA	4.0	4		F	11/22/2001	Hot, red, puffy from injection site upper arm to elbow. Localized reaction to injection site. Keflex prescribed.									U	11/21/2001	11/22/2001	1		PVT	PUB		NONE	Allergy to nuts			1						1	Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U0676AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178177	11/26/2001	MI	70.0	70		M	11/02/2001	Pt broke out with rash at 6:45. Received flu shot at clinic at 2:00 pm. I've been getting flu shots for years. Describes broke out in hives and itching relieved with Benadryl. Took at 10 AM and AM Advised to call Dr.									U	11/01/2001	11/01/2001	0		PUB	PVT	UNK				MI2001089	1						1	Pruritus; Rash; Urticaria	FLU3~EVANS VACCINES~E08791LA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0178178	11/26/2001	PA	43.0	43		F	11/14/2001	Pt had fever night of vaccination. Pt also had malais and axilla rash.				Y					U	11/07/2001	11/11/2001	4	NONE	PUB	PVT	Premarin	NONE	Betadin			1						1	Malaise; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U0669AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|RUB~MERCK & CO. INC.~0183K~1~SC~LA~RUBELLA (MERUVAX II)~1	USA	Emergency room visit	Influenza
0178179	11/26/2001	LA	78.0	78		F	11/13/2001	Excessive dizziness and very white (not just pale) for 3 days. Did not want food, very weak.									Y	10/19/2001	10/23/2001	4		OTH	OTH						1						1	Anorexia; Asthenia; Dizziness; Pallor	FLU3~SANOFI PASTEUR~U0691AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178180	11/26/2001	MI	75.0	75		M	11/12/2001	Acute labrynthitis with hearing loss in left ear and acute balance disturbance.				Y					U	10/18/2001	10/20/2001	2	Audiograms X 2 and meds . MRI done. No results recorded.	PUB	OTH		NONE				1						1	Balance disorder; Hypoacusis; Labyrinthitis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0178181	11/26/2001	MO	38.0	38		F	11/13/2001	Arm went numb up into the side of my face. right side where I got shot. Dizziness, short of breath,and nausea. The next day I got sick again. I had shortness of breath and pains going up my arm and extremely weak. First day symptoms lasted around 5 hrs and 2nd day only 2 or 3 hours, till I got medicine. I was sick feeling for 5 days . i was prescribed Claritin and Vioxx.				Y					Y	11/01/2001	11/01/2001	0		OTH	PVT	Wellbutrin, Rantidine	NONE	Allergy to PCN			1						1	Asthenia; Dizziness; Dyspnoea; Hypoaesthesia; Pain	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0178219	11/27/2001	PA	50.0	50		F	12/27/2002	Severe leg strain, muscles tight, muscle weakness. Progressive and worsening. Onset 48 hours, post vax, to present. Leg stiffness, feeling of sprained tendons and ligaments, muscle tightness, muscles in legs hardened and visible. Fevers to 101F and lymph nodes. Follow up report states  Took 4 years for patient to recover. Apathy among physicians,staff & hospital. Pt now experiences stumbling spells that probably are not related but will be examined.				Y				Y	Y	10/08/1998	10/10/1998	2	Venous/arterial doppler study; bone scan; x-rays of spine; EMG; Extensive blood panels-nml; MRI; Neurologist; Rheumatologist and Orthopedics	PVT	OTH	Inderal, Augmentin; Lanoxin; Diozide; Hytrin		Cancer survivor-breast; Allergy to fish and shellfish, ephedrine; Hypertension; PAT			1						1	Lymphadenopathy; Muscle rigidity; Muscular weakness; Pyrexia	FLU3~PFIZER\WYETH~4988239~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0178223	11/27/2001	MD	42.0	42		F	11/06/2001	Pt rec'd flu shot in am, proceeded to downstairs main lobby where she said she started to feel lightheaded & clammy. Pt laid down on a sofa & felt better; proceeded to stand up & passed out. Pt denies respiratory or cardiac distress at the time of currently. States she gets worked up over getting shots & she feels that is what precipitated her adverse rx. Pt's pulse 88 & regular, respiration 18/regular & unlabored; nails & tips pink, skin warm  & dry, denies need for further medical management.									Y	11/05/2001	11/05/2001	0	NONE	OTH	OTH						1						1	Cold sweat; Dizziness; Loss of consciousness	FLU3~SANOFI PASTEUR~U0693AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178224	11/27/2001	WA	9.0	9		M	11/16/2001	L shoulder - most superior aspect, aspect with 2cm black & blue bruise. Completely inferior but centrifuge is a 12x12cm area of redness, mild induration, mild warmth, but no significant tenderness. In future consider benadryl with flu vaccine.									Y	11/13/2001	11/15/2001	2	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Contusion; Erythema; Injection site induration; Injection site warmth	FLU3~SANOFI PASTEUR~U0601AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178225	11/27/2001	PA	4.0	4		F	11/15/2001	Left arm redness, warmth, swelling, localized, and fever. Drugs: Benadryl, Keflex.									U	11/13/2001	11/14/2001	1		PVT	PVT	NONE	NONE	NONE			1						1	Injection site oedema; Pyrexia; Vasodilation procedure	DTAP~SANOFI PASTEUR~U0296AC~5~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U0677AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~T1391~4~SC~LA~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0595L~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0178226	11/27/2001	WI	75.0	75		F	11/14/2001	Next day, pt (volunteer), states she developed redness, swelling, itching, extending to elbow. Took 1 week to resolve. Did not come in to let us observe, but told us after the fact. no medical care sought.									Y	10/14/2001	10/18/2001	4	NONE	OTH	OTH		NONE	UNK no allergies to eggs			1						1	Erythema; Injection site hypersensitivity; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U0675AB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178227	11/27/2001	WI	48.0	48		F	11/14/2001	Developed baseball sized red area, hot and tender with irregular borders slightly elevated at injection site medical diagnosed as cellulitis and was put on Keflex.									Y	10/17/2001	10/18/2001	1		OTH	UNK		NONE	No allergies to eggs.			1						1	Cellulitis; Pain	FLU3~SANOFI PASTEUR~U0675AB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178228	11/27/2001	TX	6.0	6		F		Developed severe, widespread urticaria and angioedema of her face and hands. This started approximately 20 hours after receiving the vaccine (and starting zithromax) and lasted about 3 days.									Y	10/26/2001	10/26/2001	0		PVT	PVT		Mycoplasma	Asthma			1						1	Angioneurotic oedema; Urticaria	FLU3~SANOFI PASTEUR~U0676AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178229	11/27/2001	TN	65.0	65		F	11/13/2001	Pt taking ibuprophen every 4 hrs around the clock since 11/9, fever;chills 11/11 - area hot to touch, red painful 7x3 1/2 area of swelling - tender enlarged lymph nodes - give amoxicillan 500mg tid x 7 days.				Y					U	11/09/2001	11/09/2001	0		PUB	OTH		NO	NO		TN01056	1						1	Injection site erythema; Injection site pain; Injection site warmth; Lymphadenopathy; Pyrexia; Radiation injury	FLU3~EVANS VACCINES~E00951HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0944L~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0178230	11/27/2001	OH	40.0			F	11/03/2001	Pt rec'd flu vaccine on 11/1/01 and notified Sauna on 11/2/01. On L deltoid she developed 3 circular red raised area which was sore. She stated she had the same reaction to flu shot last year. She did not seek Medical attention.									Y	11/01/2001	11/02/2001	1	NONE	PUB	PVT		NONE	same reaction to flu shot 1 year ago - got shot at another site.	red raised area, sore~Influenza (Seasonal) (no brand name)~1~39.00~In Patient	OH0064	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~EVANS VACCINES~E05231KA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0178231	11/27/2001	TX	10.0	10		M	11/15/2001	1 day after rec'd flu vaccine (and 5 d after starting Pen VK for strep pharyngitis) he developed urticaria and angioedema (face & feet), lasting 7 days (hives) (angioedema x 3 d). (I have referred for testing for Pen allergy)									Y	10/26/2001	10/27/2001	1		OTH	OTH		Strep throat	Asthma			1						1	Angioneurotic oedema; Urticaria	FLU3~SANOFI PASTEUR~U0676AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178232	11/27/2001	GA	23.0	23		F	10/31/2001	Local reaction L deltoid. Red with itching. Ice to area and 2 tsp Benadryl given po.									Y	10/31/2001	10/31/2001	0		OTH	OTH		NONE				1						1	Injection site erythema; Injection site hypersensitivity; Pruritus	FLU3~EVANS VACCINES~E05221KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0178233	11/27/2001	OH	67.0	67		F	10/24/2001	Beginning 6:30pm noticed extreme soreness on 10/22/01 R deltoid and progressed over the night to soreness and erythema & edema R upper arm from deltoid to elbow. Pain and above sx's continue as of 10:20 on 10/24/2001. Took 3 advil at 9am 10/24/2001.									N	10/22/2001	10/22/2001	0	NONE	PUB	PUB	Synthroid x3 yrs	NONE	NONE		OH0061	1						1	Injection site erythema; Injection site pain; Oedema	FLU3~SANOFI PASTEUR~U0598AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1448K~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0178234	11/27/2001	NY	22.0	22		F	11/23/2001	11/20/01 - AM nausea, vomiting, temp 100F, chills. 11/21/01 started to feel better. no vomiting, no temp, ate small amounts. No reaction at site of injection									Y	11/19/2001	11/20/2001	1	NONE	OTH	OTH		NONE	NO			1						1	Nausea; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~4018045~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0178235	11/27/2001	NY	29.0	29		F	11/23/2001	11/20/2001 Vaccine 3 PM. 11/21/2001 Felt ill, warm temp 102, nausea. Went home early from work, vomiting. 11/22/2001 Temp 99.9, nausea continues, no vomiting. 11/23/2001 arm numb.									N	11/20/2001	11/21/2001	1	NONE	UNK	UNK	Mantoux Lot CO834AB Interdermal	NONE	Latex allergy			1						1	Hypoaesthesia; Malaise; Nausea; Pyrexia; Vomiting	DTAP~SANOFI PASTEUR~~UNK~~~DTAP (TRIPEDIA)~1|FLU3~PFIZER\WYETH~4018045~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0178236	11/27/2001	CA	26.0	26		F	11/02/2001	Flu vaccine administered 10/31/2001 8-10am. Pt c/o nausea, vomiting, visual disturbances, lightheaded, diarrhea. Vaccine reaction, Tx phenergan, tylenol. Referral to PDH ER and released.				Y					Y	10/31/2001	10/31/2001	0	NONE	PUB	PVT	NONE		NKA			1						1	Diarrhoea; Dizziness; Nausea; Visual disturbance; Vomiting	FLU3~SANOFI PASTEUR~U0592AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178237	11/27/2001	MO	51.0	51		F	11/01/2001	Client reports severe tenderness, warmth, and redness beyond 4 hrs after receiving injection - currently has 12cm x 4cm area of induration redness, warmth (3 days after injection) - has not used Tylenol, ibuprofen, benadryl , etc - no treatment, applied ice to R upper arm.									Y	10/29/2001	11/01/2001	3		PUB	PUB	NONE	NONE	Iodine, codeine, morquitor, NIDDM		MO2001059	1						1	Injection site erythema; Injection site induration; Injection site warmth; Tenderness	FLU3~SANOFI PASTEUR~U0574AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178238	11/27/2001	ID	41.0	40		F	11/14/2001	SOB an felt funny after flu shot. C/O feeling cold, stridor wheezing R 24/mm, sinus tachycardia, numbness & tingling in fingers. Pulse 100-120, BP 140/90 to 165/90. Pt treated with epinephrine, benadryl, o2.					Y				Y	11/14/2001	11/14/2001	0	EKG/sinus tachycardia	PVT	PVT						1						1	Dyspnoea; Feeling cold; Hypoaesthesia; Malaise; Paraesthesia; Sinus tachycardia; Wheezing	FLU3~PFIZER\WYETH~4018040~1~SC~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0178239	11/27/2001	OR		41		F	11/20/2001	Pt had fever of 101F; pain & swelling 6x4cm over site R deltoid when flu & Pneumovax given at same time and location.				Y					U	11/08/2001	11/10/2001	2	CBC: wbc 17.6 with left shift.	OTH	OTH	Paxil, Claritin, lorigl, BCC	delayed hypersensitivity reaction	Codeine, contact dermatitis 8/01			1						1	Injection site pain; Injection site swelling; Pyrexia; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~PFIZER\WYETH~~UNK~~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0178241	11/27/2001	TX	7.0	7		M	11/14/2001	The child developed a fever of 103F and a red, hot and swollen right arm, approx. 48 hours, post vax. One episode of vomiting and fever continued for 3 days. MD evaluated and stated all tests were normal. It subsided and he is back to normal.				Y					Y	11/05/2001	11/07/2001	2	all tests were normal	PVT	PUB	Nexium; hydroxychloroquine; Trental; Vioxx; baby aspirin	NONE	Mixed connective tissue disease/on Methotrexate and Prednisone		TX01174	1						1	Injection site erythema; Injection site swelling; Injection site warmth; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U0684AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~469133~1~IM~RA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0178242	11/27/2001	WA	1.5	1	.5	F	11/19/2001	Approx. 4 hours, post vax, the pt had developed swelling in her left leg, about 3 in diameter, near the left anterior and lateral thigh. She also developed a circular rash near the injection sites. On 11/10/01, the rash on the pt's left leg had spread from the thigh to below the knee. No other symptoms were observed. The pt's mother did not notify the health dept until 11/16/01. Pt follow-up was with her PCP on 11/16/01.									Y	11/09/2001	11/09/2001	0		PUB	PUB	NONE	NONE	NONE			1						1	Injection site rash; Injection site swelling	DTAP~SMITHKLINE BEECHAM~506A2~4~IM~LL~DTAP (INFANRIX)~1|FLU3~PFIZER\WYETH~4018027~1~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HIBV~CONNAUGHT LABORATORIES~UA593AA~4~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~484134~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0178304	11/28/2001	SC	72.0			F	11/21/2001	A physician reported that a 72 year old female rec'd an injection of Flu Shield (2001-2002 formula) in 10/01. Immediately following immunization, the pt felt tired, run down, feeling bad all over and achy. On 11/8/01, she was hospitalized with acute renal failure. The pt was also diagnosed with rhabdomylysis and placed on dialysis. On 11/19/01 the pt was discharged to a nsg home where she remains on dialysis.					Y	11			U	10/01/2001	11/08/2001	38	UNK	OTH	OTH	UNK	UNK	UNK		HQ8673521NOV2001	1						1	Fatigue; Malaise; Pain; Renal failure acute; Rhabdomyolysis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0178314	11/28/2001	FL	15.0	16		F	12/27/2002	Cold symptoms and lymph adenopathy prior to menstrual cycle period (menses began). Admitted to the hospital for diagnosis and treatment 11/07-11/09. Saw nephrologist. Began Predinsone. Follow up report states Continues with Nephrotic syndrome, S/P Renal Biopsy, Minimal change, Ongoing treatment required-Pediatric Nephologist.				Y	Y	2			N	11/02/2001	11/04/2001	2	Proteinuria; rapid wt gain	PVT	PVT	Alka Seltzer (prior)	Cold	NONE			1						1	Lymphadenopathy; Nephrotic syndrome; Pharyngitis; Proteinuria; Rhinitis; Weight increased	FLU3~SANOFI PASTEUR~UO599BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0178316	11/28/2001	PA	47.0	54		M	11/22/2001	Flu shot. Guillian Barre Syndrome, onset diagnosis 11/22/2001. Now in hospital on treatment. Per 1 year follow up: It is unknown if pt has recovered. Last seen 01/08/2002. Residual symptoms presented at 01/08/2002. Hyporeflexia and mild distal sensation.  Follow up 12/13/2001: Phone # of comany who gave on original report.			Y	Y	Y				N	11/06/2001	11/15/2001	9	No spinal fluid cells. Arreflexia, weakness, spinal fluid protein increased.	OTH	UNK	Zocor	NONE	Hypercholesterolemia			1						1	CSF test abnormal; Guillain-Barre syndrome; Hyporeflexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0178321	11/28/2001	NY	62.0	62		F	11/15/2001	Approximately 7 to 10 days after receiving the vaccine, the patient experienced a temperature of 104F, cough, cold, chills, and aches.				Y					N	10/17/2001			Chest x-ray	UNK	UNK		NONE	High blood pressure and stress.			1						1	Chills; Cough; Pain; Pharyngitis; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0178322	11/28/2001	MS	45.0	45		F	11/20/2001	The patient experienced raised areas bilaterally. The patient complained of pain in her neck and lymphadenopathy.				Y					U	11/14/2001	11/19/2001	5		PUB	PUB	Premarin	NONE	Uticaria			1						1	Lymphadenopathy; Neck pain; Swelling	FLU3~PFIZER\WYETH~4018030~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0178323	11/28/2001	TX	6.0	6		F	11/20/2001	Post vax the patient was seen with a 9cm x 7 cm area of erythema, swelling and warmth at the site of the flu shot.				Y					Y	11/06/2001	11/06/2001	0	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Application site oedema; Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~V0674AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1250K~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0178324	11/28/2001	AL	50.0	50		F	11/19/2001	The patient experienced redness, swelling, warmth and muscle tremors at the site of the injection. The patient also had a fever and chills.				Y					Y	11/02/2001	11/02/2001	0	NONE	OTH	PVT	Zyrtec, Glucophage, Spenolactone, Atenolol and Premarin.	NONE	Allergies and diabetes.			1						1	Chills; Injection site hypersensitivity; Injection site oedema; Injection site warmth; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~UD696BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178325	11/28/2001	NE	10.0	10		F	11/16/2001	About 2 hours after receiving Hepatitis B vaccine in the right arm, the patient experienced tingling fingers and edema.				Y					Y	11/16/2001	11/16/2001	0	NONE	PVT	PUB	Adderall	NONE	Asthma			1						1	Oedema; Paraesthesia	FLU3~SANOFI PASTEUR~U0697AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0818L~2~IM~RA~HEP B (RECOMBIVAX HB)~1	USA	Emergency room visit	Influenza
0178326	11/28/2001	MO	44.0	44		M	11/16/2001	The patient had pain at the injection site, joint pain and hives. The patient was treated with Atarax, ice to the site and Tylenol.									Y	10/24/2001	10/26/2001	2	NONE	PVT	PVT	NONE		Allergic to ibuprofen, sulfa, Cipro and EES.			1						1	Arthralgia; Injection site pain; Urticaria	FLU3~SANOFI PASTEUR~U0591AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178327	11/28/2001	WI	22.0	22		F	11/19/2001	2 1/2 hours post vaccine, the patient experienced a headache with blurred vision which lasted until the next day. 4 hours post vaccine, the patient's finger tips became numb and 5 minutes later the patient's tongue became numb. This lasted for about 15 minutes.									Y	11/15/2001	11/15/2001	0		MIL	OTH	Orthocycline	NONE	NONE			1						1	Headache; Hypoaesthesia; Vision blurred	FLU3~SANOFI PASTEUR~U0700AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178328	11/28/2001	CA	40.0	40		M	11/19/2001	The patient experienced pain in the deltoid immediately after the injection. The patient was fatigued and light-headed three hours later. The patient had a fever of 99.8F six hours later. The patient's stomach was upset 12 - 48 hours and he could not work for 2 days.									Y	11/14/2001	11/14/2001	0		OTH	PUB	NONE	NONE	NONE	Fever~Influenza (Seasonal) (no brand name)~1~30.00~In Patient		1						1	Dizziness; Fatigue; Myalgia; Pyrexia; Stomach discomfort	FLU3~SANOFI PASTEUR~U0699AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178329	11/28/2001	NH	60.0			M		The next morning, 14 hours later, the patient was very dizzy, cold sweat and vomited. One week later the patient was dizzy again in the morning.									Y					PUB	OTH	NONE	NONE				1						1	Dizziness; Hyperhidrosis; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178330	11/28/2001	MO	56.0	56		F	11/19/2001	The patient experienced a terrible headache and facial swelling, especially upper and lower eyelids. The patient experienced extreme weakness the rest of the day and evening.									Y	10/26/2001	10/27/2001	1		OTH	PVT	Allegra-D, Synthroid and Prempro.					1						1	Asthenia; Eyelid oedema; Headache; Swelling face	FLU3~SANOFI PASTEUR~U0692AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178331	11/28/2001	OR	70.0	70		F	11/20/2001	The patient experienced severe hives all over her body beginning on 10/19/2001. The patient took various anti-histamines and was given a shot in the Dr's office. The patient is now taking Zyrtec, which so far reduces the hives.				Y					N	10/18/2001	10/19/2001	1		PVT	OTH	NPH, Humulin, insulin and spironolactone.	NONE	Diabetes			1						1	Urticaria	FLU3~SANOFI PASTEUR~U0571AD~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178332	11/28/2001	NC	37.0	37		F	11/09/2001	The patient's right upper arm was swollen, firm and painful with increased heat in an area 10cm x 10cm.				Y					Y	10/25/2001	10/25/2001	0	NONE	OTH	PUB	NONE	NONE	Asthma and pneumonia.			1						1	Injection site induration; Injection site oedema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U0597AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1070K~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0178333	11/28/2001	NC	65.0	65		F	11/06/2001	The patient experienced a 5 1/2 x 4 1/2 area of erythema and edema around and below the injection site with a tender node of the left axilla.				Y					Y	10/18/2001	10/18/2001	0	NONE	PUB	PUB		NONE	Degenerative joint disease			1						1	Injection site hypersensitivity; Injection site oedema; Lymphadenopathy	FLU3~SANOFI PASTEUR~U0682AA~7+~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~474941~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0178334	11/28/2001	CA	57.0	57		F	11/12/2001	The patient developed hives within 15 minutes of receiving the vaccine. The patient was 1st treated wtih Benadryl cream or pills. After 2 weeks and they still kept appearing, the patient was treated with methylprednisolone tablets.									Y	10/23/2001	10/23/2001	0		PVT	OTH	Arava, Premarin, Folic acid, Actonel, and Methotrexate		Arthritis and osteoporosis.			1						1	Urticaria	FLU3~EVANS VACCINES~ED4861KA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0178335	11/28/2001	DE	49.0	49		F	11/16/2001	Post vaccine, the patient experienced redness, swelling, tenderness to the touch and nausea. The patient felt hot and sick after the injection. The patient was treated with Atarax and Zyrtec.				Y					Y	11/14/2001	11/14/2001	0		PVT	PVT			Cervical dysplasia and diverticulosis.			1						1	Erythema; Feeling hot; Nausea; Swelling; Tenderness	FLU3~EVANS VACCINES~E06231KA~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1449K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0178336	11/28/2001	CA	66.0	66		M	11/12/2001	The patient continues to have muscle tenderness with movement of the left upper extremity. The patient denies tenderness to touch at the injection site.									N	10/10/2001	10/10/2001	0		PVT	PVT	Prinivil, Glucophage, Calipizide, Zocor and Prevacid.	NONE	Type II Diabetes, Hypertension, elevated cholesterol.			1						1	Myalgia	FLU3~SANOFI PASTEUR~U0598AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178337	11/28/2001	CA	32.0	32		F	11/19/2001	The patient experienced a fever of 103F and severe myalgia for 3 days with malaise. The patient woke with these symptoms the morning after receiving the vaccine. The patient took time off work and still feels weak.									N	11/14/2001	11/15/2001	1		PVT	PVT	UNK	NONE				1						1	Asthenia; Malaise; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4018032~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0178338	11/28/2001	NH	52.0	52		F	11/20/2001	On 11/14/2001 at approximately 8:00 pm the patient experienced cold chills, nausea, aches and a temperature of 102F. On 11/15/2001 at 4:00 am, the patient had improved.									Y	11/14/2001				PVT	PVT	Clonidine, Plavix, Vagifem, Flonase, Patenol and Pancrease.		Hypertension.			1						1	Chills; Nausea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U0713AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178339	11/28/2001	GA	74.0	74		F		The patient's arm is swollen, inflammed and quite warm. The patient was treated with Decadron, Depo Medrol and Levaquin.									U	11/15/2001	11/15/2001	0		PVT	UNK		NONE	Allergic to iodine/shellfish, previous mastectomy and lymphoma.			1						1	Oedema peripheral	FLU3~SANOFI PASTEUR~U0599BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178340	11/28/2001	MA		31		F	11/16/2001	Within 24 hours post vax arm injection site became swollen, hot and tender. Area of redness measured 3 X 2.										11/13/2001	11/13/2001	0		PVT	UNK						1						1	Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4018030~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0178341	11/28/2001	PA	13.0	13		F	11/20/2001	The patient experienced local redness and swelling at the area of the injection and a fever.									Y	11/16/2001	11/16/2001	0	NONE	PVT	PVT		NONE	Exercise asthma and allergic to Zithromax and Augmentin.			1						1	Injection site hypersensitivity; Injection site oedema; Pyrexia	FLU3~PFIZER\WYETH~4018028~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0996L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0178342	11/28/2001	AZ	59.0	59		M	11/20/2001	The following morning after receiving the vaccines, the patient's arm hurt and turned red for 3 days. The patient's temperature was 101F for 2 days and his whole body ached for 2 days. All symptoms were resolved after 3 days.									Y	11/16/2001	11/17/2001	1		PVT	PVT	Lipitor and Claritin.		Hyperlidpidemia and smoker.			1						1	Erythema; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U0695AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178344	11/28/2001	WI	63.0	63		F	11/19/2001	Within 24 hours after the immunization the patient developed a headache, tenderness at the injection site and left sternoclavicular swelling. The patient's temperature increased. The patient denies redness over the swollen area. The patient's headache and swelling resolved completely within 24 hours of their onset.									Y	11/13/2001	11/14/2001	1	NONE	PUB	PVT		NONE	Hyperlipidemia, CAD, Hypertension and chronic back pain.			1						1	Headache; Injection site pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U0707AA~5~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178345	11/28/2001	MI	11.0	11		F	11/19/2001	The patient experienced a large local reaction of the left arm with a 5cm x 7cm red, swelling area.									U	11/12/2001	11/13/2001	1	NONE	PVT	PVT	Advair, Singulair, Proventil, Tylenol and Afrin.		Allergic to sulfa and Vonwillebrands Disease.			1						1	Injection site hypersensitivity; Injection site oedema	FLU3~SANOFI PASTEUR~U0685AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~476952~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0178346	11/28/2001	CT	62.0	62		F	11/21/2001	Three days post vax the patient complained of a sore throat and cough. The patient did not have a fever or chills. The patient saw the MD and was advised she has a viral infection associated with the flu shot.									Y	11/08/2001	11/11/2001	3		PUB	PUB						1						1	Cough; Pharyngolaryngeal pain; Viral infection	FLU3~SANOFI PASTEUR~U0701AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178347	11/28/2001	OR	50.0	50		F	11/19/2001	The patient experienced redness at each injection site two days after the injection. The patient expereinced a fever 1 hour after the injection. The patient devleoped an irregular heartbeat, light headedness and shortness of breath.									U	11/16/2001	11/16/2001	0		OTH	UNK	Adderal, Imitrex, Remeron, Premarin, Celexa and Depakote.		Asthma			1						1	Dizziness; Dyspnoea; Heart rate irregular; Injection site hypersensitivity; Pyrexia	FLU3~SANOFI PASTEUR~U06811AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1456K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0178348	11/28/2001	AZ	8.0	8		F	11/20/2001	A few hours post vaccine, the patient developed a rash under her arms. The patient was treated with Azmacort MDI. The next morning the rash had spread to the patient's stomach and back. A baking soda bath was given and 24 hours later the rash was completely gone.									Y	11/16/2001	11/16/2001	0	NONE	PVT	PUB	Albuterol and Azmacort.	15 minute wheezing attack the night before the vaccine.	Asthma			1						1	Rash	FLU3~SANOFI PASTEUR~U0600AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178349	11/28/2001	IL	71.0	71		F		Post vax the patient complained of intermittent daily pain at the injection site.									Y	10/15/2001	10/20/2001	5		PUB	PUB	NONE	NONE	NONE			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U0574AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178350	11/28/2001	NY	51.0	51		F	11/26/2001	On 11/25/2001 the patient states she was ill with muscle aches, felt feverish, sneezing, sore throat and green nasal secretion. The patient states she was feeling better on 11/25/2001. On 11/26/2001 the patient made a follow up phone call and states she is at work and feels better.									Y	11/12/2001	11/24/2001	12	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Malaise; Myalgia; Pharyngolaryngeal pain; Pyrexia; Rhinitis; Sneezing	FLU3~SANOFI PASTEUR~U07033A~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178351	11/28/2001	MN	36.0	36		F	11/19/2001	On 11/19/2001 the patient called to report having numbness and loss of feeling to the left hand and arm on 11/17/2001. The physician instructed the patient to call Dr for further follow-up.									U	11/16/2001	11/17/2001	1		OTH	PUB	Lactulose syrup, Axid, Docusate Sodium, Lasix, Spironolactone and multivitamin.					1						1	Hypoaesthesia	FLU3~PFIZER\WYETH~4018032~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0178352	11/28/2001	TX	44.0	45		F	11/26/2001	The patient states her left ear and left side of her face became hot within a few minutes post vax. The patient took Benadryl and was OK in about 15 minutes.									Y	10/26/2001	11/26/2001	31		OTH	PVT		NONE	NONE			1						1	Feeling hot	FLU3~SANOFI PASTEUR~U0689AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178381	11/28/2001	WI	44.0	44		F	11/21/2001	Pt developed redness, swelling and heat per pt. No treatment. She never had it looked at and informed us of it today (11/21/01) and that it was better.									Y	11/19/2001	11/19/2001	0		PVT	PVT		NONE	Allergy to PCN			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U0692AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0820K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0178407	11/29/2001	AR	49.0	48		F	10/31/2001	Approx. 1 3/4 hours, post vax, the pt called the Pharmacy complaining of severe headache and chest tightness. The pt was counseled to take a dose of oral Benadryl if available and seek immediate medical attention at a medical facility. She was treated and released at the ER by a physician.				Y					Y	10/30/2001	10/30/2001	0		OTH	PVT		NONE	NONE			1						1	Chest discomfort; Headache	FLU3~EVANS VACCINES~E02791HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0178408	11/29/2001	NC	50.0	50		M	11/12/2001	On 11/9/01, pt had a red area on right arm at injection site that was painful. On 11/9/01 and 11/10/01 he had nausea and 1 episode of vomiting. On 11/10/01, he had a numb sensation on right forearm and a burning on right foot. On 11/12/01, the red area was 8cm in diameter. He also had a fever of 101.2F on 11/9/01. Pt is improving. By 11/12/01, all was resolved.									Y	11/08/2001	11/09/2001	1		PVT	PVT	Zosyn; MVI; ASA; Levofloxacin; oxycodone APAP; alprazolam; Evoxac	Osteomyelitis mandible			NC01101	1						1	Hypoaesthesia; Injection site erythema; Injection site pain; Nausea; Pyrexia; Skin burning sensation; Vomiting	FLU3~EVANS VACCINES~E02751HA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1197K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0178434	11/30/2001	NY	26.0	26		F	11/26/2001	The patient experienced redness, warm to touch and slight swelling at the vaccine site in an area approximately 2 1/4 x 1 1/2 approximately 30 hours.									Y	11/23/2001	11/25/2001	2	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Injection site hypersensitivity; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U0727AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178435	11/30/2001	NY	49.0	49		F	11/26/2001	Redness, warm to touch, slight swelling under vaccine site approximately 5x2. No fever approximately 24 hours within injection.									Y	11/23/2001	11/24/2001	1		OTH	PVT	NONE	NONE	NONE			1						1	Injection site oedema; Vasodilation procedure	FLU3~SANOFI PASTEUR~U0727AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178436	11/30/2001	MI	13.0	13		M	11/21/2001	Left arm swelling, pain and heat at injection site. Fever. Some better today recovery.				Y					Y	11/20/2001	11/20/2001	0		PVT	UNK			Allergies, Asthma, ADD.			1						1	Oedema; Pain; Pyrexia; Vasodilation procedure	FLU3~SANOFI PASTEUR~60710AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0461L~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0178437	11/30/2001	KS	1.75	3		M	11/26/2001	Large swelling and redness left detoid. Pt complains of discomfort. Not using arm as well as usual.				Y					U	11/20/2001	11/20/2001	0	NONE	PUB	OTH	NONE	11/21/2001 seen, Diagnosis: Otitis	NONE		KY2001088	1						1	Discomfort; Injection site erythema; Injection site swelling; Joint range of motion decreased	FLU3~SANOFI PASTEUR~U0701AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178438	11/30/2001	KY	47.0	47		F	11/13/2001	About 1 hours after shot given, arm started (aching whole arm) and up into neck, site of where shot was given, was red and hard knot (2-3 inches) arm and neck ached all day Saturday, seemed somewhat better, but still had large, red, knot. Accidently rubbed arm against clothes dryer and arm, neck, and back around left shoulder blade started hurting like a stiff neck, used icy hot and heating pad on back and neck helped a little. Neck, back and arm are still hurting today, but a little better.									N	11/09/2001	11/09/2001	0		PVT	UNK	Arinzide, 4-Dur 20 mg, Prenarn 12.5, Multivitamin, Calcium 1,000 mg/day		Hypertension		KY2001089	1						1	Hypersensitivity; Myalgia	FLU3~SANOFI PASTEUR~U0676AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178439	11/30/2001	IA	49.0	49		M	11/28/2001	Fever, sweating, fast heart beat dizziness.									Y	11/27/2001	11/27/2001	0		PUB	PVT		NONE	Allergies to dust and mold	see 7~Influenza (Seasonal) (no brand name)~~49.00~In Patient		1						1	Dizziness; Hyperhidrosis; Pyrexia; Tachycardia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178441	11/30/2001	MO	34.0	34		F	11/26/2001	The patient started on 11/07 with a fever and headache which progressed over 9 days with malaise, hives, itching, fever up to 102F, body aches and coughing up to 9 days after the vaccine.				Y					U	11/07/2001	11/07/2001	0	NONE	PUB	PVT	NONE	NONE	Ileostomy, ulcerative colitis and allergic to sulfa and tetracycline.			1						1	Cough; Headache; Malaise; Pain; Pruritus; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U0590AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178442	11/30/2001	VT	48.0	49		F	11/05/2001	The patient felt pain after the injection and had to lie down. It was several days until the whole body pain went away.									Y	10/03/2001	10/03/2001	0	NONE	PUB	PVT		NONE				1						1	Pain	FLU3~SANOFI PASTEUR~U0600AA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178443	11/30/2001	VT				U		The patient had generalized pain, cramps, abdominal pain and dizziness for about 2 weeks.									Y	10/03/2001	10/03/2001	0	NONE	PUB	UNK						1						1	Abdominal pain; Dizziness; Muscle spasms; Pain	FLU3~SANOFI PASTEUR~U0600AA~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178444	11/30/2001	VT				F	11/21/2001	Post vax the patient's ears started popping, she felt dizzy, her equilibrium was off all weekend, middle ear was stuffed and she had pressure in the head areas.									Y	10/14/2001	10/15/2001	1		PUB	UNK						1						1	Balance disorder; Dizziness; Ear discomfort; Ear disorder; Headache	FLU3~SANOFI PASTEUR~U0600AA~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178445	11/30/2001	MD	55.0	55		F	11/27/2001	Post vax the patient stated the left deltoid was itching and red. The patient was treated with Benadryl. The patient also complained of tightness in her throat, a rash and shortness of breath. The patient became anxious, stated she needs air and wheezing started. The patient was treated with Albuterol Nebulizer. The patient's coughing decreased with the nebulizer treatment. The patient's chest and back were itching. The patient experienced hives on her neck and chest. The wheezing cleared and the patient's throat was dry.				Y					Y	11/06/2001	11/06/2001	0		PVT	UNK						1						1	Anxiety; Asthma; Cough; Dyspnoea; Injection site hypersensitivity; Pruritus; Rash; Throat tightness; Urticaria	FLU3~EVANS VACCINES~E06751LA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0178467	12/03/2001	IL	41.0	42		F	01/03/2002	A 41 year old female consumer reported that she received Influenza virus vaccine, Trivalent, Types A and B (2001-2002 formula) (manufacturer unknown) on 23-OCT-2001. Concomitant medication included Zestoctic (manufacturer unknown). On 08-NOV-2001, she developed numbness in her toes and finger, the middle of her back and the tip of her tongue. She also experienced excruciating pain. On 23-NOV-2001, she was hospitalized. Laboratory tests included EMG, MRI and spinal taps (results not reported). The reporter noted that Guillian Barre was ruled out. On 27-NOV-2001, she was discharged without a diagnosis. She is scheduled to see a Neurologist. No additional information was available as of the date of this report. Follow up info received 12/31/01. Lab test results were reported. Nuclear magnetic resonance imaging results reported aas lesion in T-spinal cord. Lumbar puncture results reported increased protein. Electromyogram results were consistent with peripheral neuropathy.				Y	Y	4			U	10/23/2001	11/08/2001	16	Laboratory tests included EMG, MRI and spinal taps (results not reported). Nuclear magnetic resonance imaging results reported aas lesion in T-spinal cord. Lumbar puncture results reported increased protein. Electromyogram results were consistent with peripheral neuropathy.	PVT	OTH	Zesrorectic Zeneca	NONE	High blood pressure		HQ8967629NOV2001	1						1	Hypoaesthesia; Neuropathy peripheral; Pain; Proteinuria	FLU3~SANOFI PASTEUR~U692AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0178470	12/03/2001	CA	70.0	71		M	11/29/2001	Pt developed body aches, chills, sore throat and increasing difficulty swallowing with swelling of lip, 1 day after receiving influenza vaccine injection and about 8 weeks after beginning Allopurinol (history of receiving influenza vaccine yearly without reaction; Allopurinol initially 100mg OD but increased to 300mg several weeks later). Pt had 80% to 90% body surface area sloughing (Toxic Epidermal Necrolysis). Admitted to the hospital, 1 day after development of above mentioned signs and symptoms; allopurinol discontinued and treated with antibiotics and steroids. After 16 days in the hospital, he was transferred to another hospital service where steroids were discontinued; treated with IVIG, silver nitrate topical. Wounds continued to slough and pt expired on 5th hospital day.	Y	11/09/2001					Y		N	11/04/2001	11/05/2001	1		UNK	UNK	Allopurinol; benazepril; burnetanide; KCI; simvastatin; warfarin; colchicine; prenatal vitamins; epoetin alpha; pamidronate; metolazone; insulin		Multiple myeloma; Rheumatic heart disease with mechanical valve; Gout; DM; HTN; decreased renal function and Obesity			1						1	Chills; Dysphagia; Pain; Pharyngolaryngeal pain; Skin exfoliation; Swelling face; Toxic epidermal necrolysis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0178473	12/03/2001	NJ	37.0	37		F	11/26/2001	Pt went into A-Fibrillation. EMT's could not regulate, therefore, ambulance took pt to ER.				Y	Y	4			Y	10/22/2001	10/26/2001	4	EKG; Echocardiogram-neg; Blood sugar-raised to diabetic lever when admitted; BP-raised	PVT	OTH	Ortho-Novum 777; Claritin-D/Serevent Paxil, Wellbutrin	NONE	Asthma; Allergy to pollen/dust and mold			1						1	Atrial fibrillation; Blood glucose increased; Blood pressure increased	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0178476	12/03/2001	MA	53.0	53		M	11/30/2001	Shot at 10:30 AM on 11/29/2001. One hour: blurry vision, numbness in both arms and hands. Weak leg (left). At 2 PM blotchy, trembling hands. Joint aches. Headache. Twenty-seven hours later, left wrist and fingers numb, burning and painful.									N	11/29/2001	11/29/2001	0		OTH	UNK	Hytrin 2.0 mg and Prilosec		Sulfa drugs (rash)			1						1	Arthralgia; Asthenia; Headache; Hypoaesthesia; Pain; Rash maculo-papular; Tremor; Vision blurred	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178477	12/03/2001	MA	55.0	54		F	11/20/2001	Flu immunization given on 10/29/01. The following day, pt discovered a rash and 1 day later, this rash covered her entire body. Allergic reaction to Flu vaccine.									U	10/29/2001	10/31/2001	2		OTH	OTH			Allergy to Penicillin			1						1	Hypersensitivity; Rash	FLU3~SANOFI PASTEUR~U0671FA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178478	12/03/2001	VT				F	11/21/2001	The pt developed pain at the injection site, initially on 10/19/01, and the pain worsened. It went up the neck and down arms to chest and down hands to 4th and 5th digits which was prickly. Cannot move right arm. Seen MD and the flu vaccine could not be ruled out. It may be related.									Y	10/10/2001	10/17/2001	7		PUB	OTH						1						1	Hypokinesia; Injection site pain; Paraesthesia	FLU3~SANOFI PASTEUR~U0600AA~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178479	12/03/2001	SC	69.0	69		F	11/20/2001	Local reaction									Y	10/09/2001	10/12/2001	3	NONE	PVT	UNK	MVI, Lovazepam, Elotris, Trimethoprim, Mevacor, Zantac Toprol Nitorpatch, Premarin, Urecholine, Paraton forte, Ultram, Lactulose, Celebrex and Bumex	NONE	Sulfa, morphine and Benadryl			1						1	Injection site reaction	FLU3~SANOFI PASTEUR~UO600AA~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178480	12/03/2001	VA	50.0	50		F	11/28/2001	About 2.5 hours after immunization client developed hives over arm, legs and trunk with itching. No other symptoms. Has taken flu shots for years.									N	11/27/2001	11/27/2001	0	NONE	PUB	OTH	Zyrtec, Diabeta and Glucophage	NONE	Diabetes			1						1	Pruritus; Urticaria	FLU3~PFIZER\WYETH~4618026~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0178481	12/03/2001	TX	60.0	60		F	11/21/2001	Extreme swelling of left arm. Flu symptoms within 2 to 3 hours and fever. Red rash on left arm. Very ill with drainage, congestion, cough, sore throat, finally saw MD who gave Zpak.									Y	10/22/2001	10/22/2001	0	MD said URI one week after onset of above symptoms.	OTH	OTH	Zocor, Cazoor, Norvasc, Depakote, Zoloft and Melaril	NONE	High blood pressure; treatment for depression.			1						1	Conjunctival hyperaemia; Cough; Injection site hypersensitivity; Malaise; Oedema; Pharyngitis; Rash	FLU3~SANOFI PASTEUR~UO588AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0178482	12/03/2001	MD	53.0	53		F	11/08/2001	Day 1: after injection itching. Day 2: wheals, rash over left upper and lower arm, intense itching.				Y					Y	11/06/2001	11/07/2001	1		PUB	UNK	Claritin 10 mg 1 tablet for 7 days. Cortisone cream topically BID. Triantherene	NONE	High blood pressure		VA01035	1						1	Pruritus; Rash; Urticaria	FLU3~PFIZER\WYETH~4018028~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0178483	12/03/2001	VA	75.0	75		M	11/15/2001	Bleeding from roof of mouth starting 11/13/2001. Is on Coumadin daily. MD told pt that flu vaccine elevated PTT and INR.				Y					Y	11/08/2001	11/13/2001	5	PTT and INT drawn 11/13/2001 and 11/15/2001.	PUB	PUB	Coumadin and Alpha-Beta blocker	NONE	Pacemaker, borderline renal failure, CVA		VA01033	1						1	Haemorrhagic diathesis; Laboratory test abnormal	FLU3~PFIZER\WYETH~4018028~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0923L~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0178484	12/03/2001	NY	60.0	60		F	11/21/2001	Pt's right arm was hot to touch and very sore shoulder and arm. She had several red, blotchy areas and spreading.				Y					U	11/19/2001	11/20/2001	1		PVT	OTH		Sinus congestion	GERD; DJD; Allergies/sinus; High cholesterol; Depression; Cardiac Catheter at age of 38.			1						1	Erythema; Injection site pain; Injection site warmth; Rash macular	FLU3~SANOFI PASTEUR~U0677AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0801L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0178485	12/03/2001	UT	76.0	76		M	11/26/2001	Pt began experiencing pain at the injection site, a few days after immunization. His whole arm has been throbbing and the pain is not relieved by any medications that he has taken.									N	11/01/2001				OTH	PVT						1						1	Injection site pain	FLU3~SANOFI PASTEUR~U0681AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178486	12/03/2001	NC	57.0	57		F	11/26/2001	Area of injection was red and swollen 35mm X 55mm.									Y	11/19/2001	11/20/2001	1		PUB	PVT		NONE				1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U0726AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178487	12/03/2001	VA	30.0	30		F	11/26/2001	Received vaccine at 2:30 PM. Symptoms began 6 PM that day, stomachache, vomiting, temp 101.3, muscle and back ache, swollen left eye, redness, asthma-had to go to PMD for asthma treatment. Recovery took 5 days. Return to work 11/12/2001. Pt had had her first flu shot last year.				Y					Y	11/06/2001	11/06/2001	0	NONE	OTH	OTH	Albuterol	NONE	Asthma			1						1	Abdominal pain; Asthma; Oedema; Pain; Pyrexia; Vasodilation procedure; Vomiting	FLU3~PFIZER\WYETH~4018026~2~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0178500	12/03/2001	OH				F	11/26/2001	Flu shot given. Approximately 9 minutes later, pt reported, felt funny, heart racing BP 174/94, P 126, R 12. Skin warm, dry, pink, ho SOB. At 6:24 AM 160/90-92-12. Nose stuffy, feels better 6:23 AM 134/90-92-12 better 6:32 AM 132/86-80-12. No heart racing, calmer. 6:38 AM 126/82-76-12, okay back to work. 6:46 AM 16/82-124-24 back hurts, racing heart and throat slight tightness. Gave Epi. 0.5cc SQ. Skin cool and dry pt fearful, medic called, arrived 6:53 AM BP 170/100-140 lungs clear. Medic feels reaction is anxiety, leave 7:11 AM. 7:13 AM 140/82-92-12. Pt back to work. 7:40 AM working, no symptoms or complaints. 140/82-88, color pink, skin warm and dry. This was the pt's first time getting a flu shot.									Y	11/23/2001	11/23/2001	0		OTH	PVT		NONE	NONE			1						1	Anxiety; Back pain; Blood pressure increased; Dry skin; Feeling hot; Heart rate increased; Laryngospasm	FLU3~SANOFI PASTEUR~UO683CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178523	12/04/2001	CT	69.0	69		M	12/03/2001	2 days, post vax, the vaccinee complained of chills, myalgias and shortness of breath. 3 days, post vax, his temperature was 102F; CXR with infiltrate and pulse ox 85%. He was admitted and rx'd with Zithromax, O2 and steroids. CXR and clinical determination to ARDS, mechanical ventilation and death. Autopsy findings state cardiomegaly and left and right ventricular hypertrophy; focally calcified mitral valve. Secondary findings: ascites.	Y	11/17/2001			Y				N	10/25/2001	10/27/2001	2	Bronchoscopy; open lung biopsy; CXR-infiltration	PVT	PVT	Prednisone 20 mg BID times 3 weeks. Discontinued same day.	Pulmonary fibrosis				1						1	Ascites; Cardiomegaly; Dyspnoea; Hypoxia; Mitral valve incompetence; Myalgia; Pyrexia; Respiratory disorder	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0178524	12/04/2001	PA	44.0	44		M	12/18/2001	It was reported by the pt that he, a 44 year old male, received a Fluzone '01-'02 vaccination on 10/26/01. The pt developed double vision on 10/28/01; the double vision is still persisting. Pt also experienced tingling in hands and feet, and a general feeling of malaise. He complained of pain in his neck and continued pressure behind his eyes and has a splitting headache. The pt has seen a neurologist, internal medical doctor and an Ophthamologist. He was dx'd by the Ophthamologist as having post viral encephalitis triggered by the flu vaccination. The pt did state that no spinal tap was performed as of yet. From follow up correspondence received on 12/14/01 additional pt, vaccine, responsible physician, vaccine administrator and laboratory data was provided. From follow up correspondence received on 12/14/01 additional patient, vaccine, responsible physician, vaccine administrator and laboratory data was provided. From follow up correspondence received on 2/11/02 the following information was provided from teh physicians notes dated 1/14/02. The patient returns reporting overall he feels much better. He feels his ptosis is completely resolved. He feels wach eye is moving much better at this time but he questions whether his eyes are crossing inwards more. The patient has previous opthalmic history with regards to his spectacles. When examining his refraction he has a marked optical diffrence between his two eyes with his right eye being much more hyperopic than his left. He is experiencing minimal if any diplopia at this time. The patient is showing a marked improvement in his overall gaze paresis. At present he has relatively full duction in both eyes. His ptosis has also improved. However, he is demonstrating an increase in his objective strabismus angle with partial sensory suppression of his right eye. The fact that this tribasic angle is overall increased at this point is not necessarily concerning. In particular, he had very limited duction in all fields of gaze before which might potentially hide his true angle of strabismus secondary to his relatively late age along with a slightly decreased acuity in his right eye all suggests ahistory of a mild anisometropic amblyopia on the right with partian sensory suppression of that eye chronically. At this time I am very comfortable with his overall progress. From the neurologist office visit notes dated 1/29/02, the opthalmologists feel that his gaze paresis is improving, his ptosis has resolved but he does have an esotropia. On exam, his right eye does tend to go in, he can make it go out by covering his left eye as can be demonstrated with the cover/uncover test. He  says he does tend to have some double vision when looking to the right. He does have a history of chronic decreased vision in the right eye but he has no history of double vision in the past and he feels that his right eye did not go in in the past. He is not having any trouble swallowing; he's not having any numbness in his extremities. He is taking TASA and 2 Advil, which the doctor recommended. The etiology of his illness is still not known although some people feel that it is related to his influenza vaccine. There is no good documentation of that nor is there any known incidence of this occurring. Whether this is an early presentation of MS is still uncertain.									U	10/26/2001	10/28/2001	2	MRI brain, Orbit cervical spine, Lyme titer, Myasthenia panel - results not provided.	PVT	UNK	Serevent, Flovent	Recent viral gastroenteritis	Asthma; Previous opthalmic history with regards to his spectacles. He has a marked optical difference between his two eyes with his right eye being more hyperopic than his left.		U2001011820	1						1	Diplopia; Encephalitis; Headache; Malaise; Neck pain; Paraesthesia	FLU3~SANOFI PASTEUR~U0679DA~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178528	12/04/2001	AL	12.0	12		F	11/24/2001	Significant reaction to flu shot taken 11/13/2001. Area around injection site had fist sized raised, red, swelling and was extremely hot to the touch, as well as sore, child vomited over 5-6 hours to the point of dehydration, headache and high fever.					Y				Y	11/13/2001	11/15/2001	2	UNK	UNK	UNK						1						1	Cellulitis; Dehydration; Headache; Injection site hypersensitivity; Injection site oedema; Pyrexia; Rash maculo-papular; Vasodilation procedure; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0178530	12/04/2001	MI	61.0	61		F	11/21/2001	Onset 11/20/01 7 AM with stomach upset, cramping, chills, diarrhea times 24 degree.									U	11/19/2001	11/20/2001	1		PUB	UNK	Pulmicort, Requip 11/19/01 increased dose Zestoretic, Premarin, Nasacort		Environmental allergies, asthma, gall bladder removed.			1						1	Chills; Diarrhoea; Dyspepsia; Pain	FLU3~PFIZER\WYETH~4018045~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0178531	12/04/2001	MI	65.0	65		M	11/27/2001	Woke up achey all over, arms sore within site of injection. Fever and achey on and off for 2 weeks after, fever up to 100.4 degree.				Y					U	11/02/2001	11/03/2001	1		PUB	OTH	11/23/01 started Biaxin B/O with visit to physician.					1						1	Arthralgia; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~4018028~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0946K~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0178532	12/04/2001	GA	83.0	83		M	11/26/2001	Client received flu vaccine 11/07/2001 approximately 2 days later he noted bruising on the inner aspect of left arm where vaccine given, no redness or swelling noted at injection site, upper arm moist heat to affected area.				Y					Y	11/07/2001	11/10/2001	3		PUB	PVT	Tylenol/600mg prn, Tylenol 400 mg TID.	NONE	Poor circulation extremities.			1						1	Ecchymosis	FLU3~PFIZER\WYETH~4018028~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0178533	12/04/2001	CA	13.0	13		F	11/26/2001	Red, raised patch overlying entire left deltoid.				Y					U	11/23/2001	11/24/2001	1		PVT	PVT						1						1	Injection site mass	FLU3~SANOFI PASTEUR~U0684AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178534	12/04/2001	NY	29.0	29		F	11/27/2001	Left upper extremity arm region 1 3/4x1 1/2 (5cm round) red area, itching. Red rash non raised area Bilateral inner forearm and back of  neck. Benadryl taking with relief. 11/27/01 rash faded, red area left upper arm faded. Occasional itching. Still taking Benadryl.									Y	11/23/2001	11/24/2001	1		OTH	PVT			Vancomycin allergy, amoxicillin allergy.			1						1	Hypersensitivity; Injection site erythema; Pruritus	FLU3~PFIZER\WYETH~4018040~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0178535	12/04/2001	IN	73.0	73		M	11/26/2001	States rec'd vaccine at 4:15 Thurs.- by 10 PM Thurs. chills causes to bed, sweats (2 blankets and elec on hi) cycled about q8h. Temp ranged from 100-103,5, achey all over. Pink rash on legs, chest, back Fri. AM Took Benadryl and ibuprofen per doctor orders. Felt OK by Sunday. Rash gone by Monday AM.				Y					Y	11/08/2001	11/08/2001	0		OTH	PVT	Allergic PCN, Sulfa	NONE				1						1	Myalgia; Pyrexia; Rash	FLU3~EVANS VACCINES~E06751LA~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0178536	12/04/2001	OR	35.0	35		F	10/05/2001	Pt was sent to ER with another employee in private car. Pt check out swollen arm from shoulder to finger tips, right arm. Pt stated that as a child, she had an allergy to mayonnaise, no egg allergy as an adult. Arm began swelling one hour after shot resolved two hours later.				Y					Y	10/05/2001	10/05/2001	0		PUB	PVT		Had just recovered from URI with ATB's.	Fibromyalgia/chronic back pain			1						1	Injection site oedema	FLU3~EVANS VACCINES~E04861KA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~SMITHKLINE BEECHAM~3066A4~UNK~IM~LA~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0178537	12/04/2001	PA	31.0	31		M	11/28/2001	13:00 nausea and vomiting times 1, 13:55 PM TPR/BP 97.2 Temp 74P 16R, BP 146/88. C/O pain at injection site. Stated in ED had same reaction to Flu vaccine last year ( Denied any past problem with flu vaccine at time of administration). TX: IV NSS and 200 mg Reglan 10 mg IV and Benadryl 25 mg IV.				Y					Y	11/15/2001	11/15/2001	0	CBC, UA, Chem	PVT	OTH	IV NSS and 2OO mg of Reglan 10 mg IV, Vitamins	NONE	Diagnosed: Gastroenteritis 2-3 days recovery.			1						1	Injection site pain; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U0668AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178538	12/04/2001	MA	77.0	77		F	12/03/2001	Nickel size redness to left arm check out itchiness. Denies hardness or pain. Explained need to keep clean, covered and put Bacitracin on.									U	11/27/2001	11/29/2001	2		PUB	OTH		NONE				1						1	Injection site erythema	FLU3~SANOFI PASTEUR~A0676AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178540	12/04/2001	WV	45.0	45		F	11/28/2001	Lump at injection site size of small hen egg appeared next evening. Area pink and warm to touch and tender. Next AM (11/26/01) was still tender and inflamed. Went to Dr. and was given erythromycin. T/D x6 days. 11/29- Per client and area is  1cc swollen and only slightly red in center. No pain with arm movement.				Y					Y	11/26/2001	11/27/2001	1		OTH	PVT			Allergy Sulfa and PCN, Toxoplasmosis-eyes; TB converter.		WV0113	1						1	Injection site inflammation; Injection site mass; Pain; Vasodilation procedure	FLU3~SANOFI PASTEUR~U0696AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178542	12/04/2001	FL	38.0	37		F	11/30/2001	Acute muscle atrophy of left arm-base on physical examination.										11/08/2001	11/29/2001	21	CPK done with a result of 70.	PUB	PVT	NONE	NONE				1						1	Blood creatine phosphokinase increased; Injection site atrophy	FLU3~SANOFI PASTEUR~U0669AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178543	12/04/2001	KY	41.0	41		M		Received immunization 10 mm at 10:15 AM. Burning at site immediately and arm continued to burn and achey after got home, temperature 101.3F. Aching all arm. Low greater fever. Fells like he's been beat-up.									Y	11/26/2001	11/26/2001	0		PUB	UNK	medication for irritation Bowel Syndrome	On medication Cipro for infection in arm.	Irritable bowel Syndrome.		KY2001090	1						1	Myalgia; Pain; Pyrexia	FLU3~PFIZER\WYETH~4018043~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0178544	12/04/2001	CA	80.0	80		M		Felt a little dizzy off balance time 3 days, emesis thus Ave without diarrhea or fever. Slight increase in Blood Pressure. No increase confusion, no tinnitus.									Y	11/16/2001	11/19/2001	3	NONE	PVT	UNK		NONE	Post CVA			1						1	Dizziness; Hypertension; Vomiting	FLU3~SANOFI PASTEUR~U0695AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178545	12/04/2001	MA	28.0	28		F	11/16/2001	8 hours after IM flu vaccine injected into left deltoid swelling, inflammation, itching, 24-48 later site measures 30x60, induration.				Y						11/14/2001	11/14/2001	0		PVT	OTH						1						1	Injection site inflammation; Injection site mass; Injection site oedema; Injection site reaction; Pruritus	FLU3~SANOFI PASTEUR~U0693AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178546	12/04/2001	OH	68.0	68		F	11/02/2001	couple of hrs after shot R upper arm became very red, ran fever.(did not take temp); arm swollen. Treated with ice and tylenol. Also had complaint chest pain and sinus problems. Did not seek medical care, came back to clinic 11/2/01,830am. Pt arm (R) red and warm to touch below injection site. Recommended she call primary MD today.									Y	10/31/2001	10/31/2001	0	NONE	PUB	PUB	Premarin, vitamins, Lipitor	denies illness	Denies, had reaction to iodine about 10 yrs ago in test		OH0066	1						1	Chest pain; Injection site erythema; Pyrexia; Sinusitis; Swelling	FLU3~EVANS VACCINES~E08341LA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1448K~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0178547	12/04/2001	OH	23.0	23		F	11/14/2001	9pm pain at injection site R arm, sore from deltoid to elbow. Redness, swelling shoulder to 3/4 way toward elbow. Hot to touch. Pt is 17 wks pregnant recommended motrin, ice, cold compresses. She will check with OB re: use of motrin.									Y	11/13/2001	11/13/2001	0	NONE	PUB	PUB			NONE		OH0065	1						1	Erythema; Injection site pain; Injection site warmth; Swelling	FLU3~SANOFI PASTEUR~U0693AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0995L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0178548	12/04/2001	MA	65.0	65		F	11/13/2001	Three hours after receiving the pneumonia shot in the left deltoid, developed severe painin upper arm to elbow to under arm pit. In 4-5 hours after injection, developed swelling, redness, hotness and hardness of upper arm. Also, chills and nausea. Lasted 2 full days then symptoms gradually decreased 3 or 4 days.									Y	11/06/2001	11/06/2001	0	NONE	PVT	PUB	Baby ASA, Cardizem, Isordil, Norvac, Visken, Zantac, Premarin, NTG patch	NONE	Heart disease, allergic to latex, dermatitis, S/P MI, Repair of left rotator cuff AUG 2001.			1						1	Chills; Injection site hypersensitivity; Nausea; Oedema; Pain; Vasodilation procedure	FLU3~SANOFI PASTEUR~UO676AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~474939~2~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0178549	12/04/2001	TN	55.0	55		F	11/13/2001	Pt states she received flu shot in clinic 11/07/2001. Pt back in clinic 11/08/2001 with aunt so aunt could get flu shot. Pt pointed out site of her flu shot received prior as being sore. Left arm above elbow red, warm and swollen. Instructed to begin cool compress today, warm tomorrow and Aleve.				Y					U	11/07/2001	11/07/2001	0		PUB	PUB		NONE	Latex		TN01061	1						1	Injection site reaction; Oedema; Pain; Vasodilation procedure	FLU3~PFIZER\WYETH~4018023~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0178550	12/04/2001	NY	52.0	52		F	11/20/2001	11/19/01 @0930 spoke with pt. C/O hives on both arms and chest area. Not sure if anywhere else don't think so. At injection site LD red, hot, swollen area 8cm around site. C/O itching no SOB, no difficulty breathing. Instructed to call MD or go to ER. Dr office called instructed to take benadryl 50mg po q/4 until itching subsides. On 11/20/01 spoke with pt rash fading, still itches, not as bad, no SOB, states did have hives over entire body. arms, chest, neck, legs and back. Instructed to call 911 or go to ER if any difficulty breathing by MD.									Y	11/16/2001	11/19/2001	3	NONE	OTH	PUB	Zoloft 50mg qd, Welbutron bid	NONE	NONE			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Urticaria	FLU3~PFIZER\WYETH~4018032~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0178551	12/04/2001	IL	39.0	0	.0	F	11/27/2001	Developed rash on face.									U	11/21/2001	11/21/2001	0		OTH	PVT		NONE	NONE			1						1	Rash	FLU3~EVANS VACCINES~E11931LA~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0178552	12/04/2001	ND	48.0	48		F	11/20/2001	Local reaction on left arm, occurred approximately 6 hours after administration. Area red, swollen and firm. Also itchy and faded after 2 days of administration. Applied aloe and green tea soothing burn cream one time only. (per pt)									Y	11/05/2001	11/05/2001	0	NONE	OTH	PVT	NONE	NONE	Allergic to gold and metal			1						1	Injection site hypersensitivity; Injection site reaction; Oedema; Pruritus	FLU3~SANOFI PASTEUR~UO598AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178553	12/04/2001	MA	42.0	42		F	11/27/2001	Fever, rash, small bumps reddened and white all over arms, legs, chest, etc. Joint pain (severe), headache, facial, neck swelling, eye swelling and nausea. MD stated classic drug or serum sickness/reaction. Symptoms for 2 weeks. Treated with Benadryl and Tylenol. Also worsening in asthma symptoms, increase in asthma meds. MD suspicious of thimersol allergy. No history of egg allergy.				Y					Y	11/23/2001	11/25/2001	2	NONE	PVT	OTH	Zoloft, Accolate, Flovent, etc	NONE	Asthma (grade 4), etc	fever, oint pain and swellin at injectin site~Hep B (no brand name)~3~32.00~In Patient		1						1	Asthma	FLU3~SANOFI PASTEUR~VO571AD~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178554	12/04/2001	CA	5.0	5		M	11/27/2001	Red, raised patch overlaying entire left deltoid.				Y					U	11/21/2001	11/22/2001	1		PVT	PVT	Penicillin					1						1	Rash maculo-papular	FLU3~SANOFI PASTEUR~4018028~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178555	12/04/2001	IN	45.0	45		F	11/27/2001	Hives on legs, some difficulty breathing (is an asthmatic), hoarseness, dizziness, weakness, headaches. Advised to call physician or go to ER if condition worsened. Seen in ER, given Motrin and sent home.				Y					Y	11/26/2001	11/26/2001	0		PUB	PUB	NONE	Asthma	Asthma and arthritis			1						1	Asthenia; Asthma; Condition aggravated; Dizziness; Dysphonia; Dyspnoea; Headache; Urticaria	FLU3~PFIZER\WYETH~4018042~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0178556	12/04/2001	MI	7.0	7		M	11/27/2001	more than 30 less than 50 varicella lesions, papules, vesicles and crusted vesicles									Y	11/02/2001	11/22/2001	20		PVT	OTH		NONE	Metabolic disorder NOS, microcophage, hearing loss, hypotonia, SOB once.			1						1	Rash vesicular	FLU3~SANOFI PASTEUR~U0672AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0788L~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0178557	12/04/2001	OR	63.0	63		F	11/04/2001	The patient broke out in rough purple-like rash approximately 22 hours after the vaccination. The patient had the rash on his arms, chest, back and buttocks. The patient did not have any breathing problems and was afebrile. The patient states she is very uncomfortable due to itching. The patient was treated with Zyrtec, Pforcone and Benadryl.				Y					Y	11/01/2001	11/02/2001	1	NONE	PUB	PVT		NONE	NONE		OR200144	1						1	Rash pruritic	FLU3~SANOFI PASTEUR~U0588AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178558	12/04/2001	MI	69.0	69		F	11/30/2001	Pt had slight pain and discovered pink rash about 11pm same day (11/26/01) 11/27 pain increased and redness increased 11/28 itching in red area, pain went to middle of forearm. 11/30 pain has dimished 75% itching has subsided but is still pink.									U	11/26/2001	11/26/2001	0		PUB	PVT		NONE	NONE			1						1	Injection site hypersensitivity; Injection site pain; Injection site rash; Pruritus	FLU3~PFIZER\WYETH~401045~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0946K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0178559	12/04/2001	MA	63.0	63		F	11/28/2001	Rec'd influenza vaccine 11/13/2001 on 1/20/2001 developed progressive generalized muscle pain, night sweats, fatigue lasting until 11/22/01. No other c/o. Reported to BOH 11/27/01.									Y	11/13/2001	11/20/2001	7	NONE	PUB	OTH	Atenolol	NONE	hypertension			1						1	Fatigue; Myalgia; Night sweats	FLU3~SANOFI PASTEUR~U0676AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178560	12/04/2001	IN	33.0	33		M	11/26/2001	High temp - 103.3F, dizziness, vomiting, weakness, ten hrs of symptoms.									Y	11/20/2001	11/20/2001	0		PUB	PUB	NONE	NONE	NONE			1						1	Asthenia; Dizziness; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~4018032~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0178561	12/04/2001	NJ		35		F	11/28/2001	Pt c/o headache, vomiting 2 times. Had Flu shot, ate lunch and then vomited about 1/2 hr later, then pt states that she began feeling lightheaded, nauseated, and headaches. Vomited only her lunch. No blood , etc. No other concommittant symptoms noted. No hives, pruritis, shortness of breath, or sensations of throat closing. Pt has a lifelong history of allergies including seasonal, animal, food and other materials. She has an epipen to use prn and takes Claritin for hay fever. Pt noted that she has had the development of a small wheal at her injection sites in the past when she has gotten the vaccine but never had any other concommittant symptoms. No wheal noted today. It should be noted that the pt who has multiple allergies has never manifested a reaction as noted above. She noted that she usually would feel her throat get tight and begin having hives. (which did not occur today). Vital signs remained stable. Treated with Benadryl 50mg/IM followed by oral Benadryl later on in the evening. Symptoms resolved. Pt was discharged in stable condition.				Y					Y	11/16/2001	11/16/2001	0		OTH	PVT		NONE	Seasonal, food, animal, and other material allergies			1						1	Dizziness; Headache; Urticaria; Vomiting	FLU3~SANOFI PASTEUR~00696BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178592	12/05/2001	MI	99.0	99		M	12/04/2001	High fever 1 AM on 11/23/2001. Taken to hospital. Diagnosis of Urosepsis.	Y	11/23/2001							N	11/20/2001	11/23/2001	3	Positive for bacteria in urine, polynephritis, WBC 40,000 +.	OTH	PVT	NONE	UNK	UNK			1						1	Nephritis; Pyrexia; Urinary retention; Urine analysis abnormal; White blood cell disorder	FLU3~SANOFI PASTEUR~UO691AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0178612	12/05/2001	WA	1.56	1	.6	M	11/27/2001	Seen 11/18/01 with progressive lower extremity weakness. By 11/30/01 could not move lower extremities: had loss of reflexes. Sent to ED where diagnostic work up began. Diagnosis of Guillain-Barre Syndrome ultimately made. Per 1 year follow up: Pt recovered. Done well with therapy time.					Y	4			U	11/06/2001	11/16/2001	10	Normal head CT scan CSF increased protein, 2 WBC /mm3	PVT	PUB		autoimmune pancytopenia, chronic atelectasis, cirrhosis	RML pneumonia, hepatosplenomegaly, hepatitis , autoimmune pancytopenia			1						1	CSF test abnormal; Guillain-Barre syndrome; Muscular weakness; Paralysis	FLU3~SANOFI PASTEUR~U0669AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0178613	12/05/2001	MO	62.0	62		M	11/26/2001	Hives within 5 minutes after flu injection, tachycardia and became short of breath and thought he was going to pass out. Sent to ER and was hospitalized for atrial fibrillation.				Y	Y	4			Y	11/16/2001	11/16/2001	0	Penicillin, sulfa and corn based substance	PVT	PVT	Synthroid 125 mg and Centrum Silver OTC.	Abnormal ECG	Hypothyroidism; hypertension; hyperlipidemia; drug depend (alcohol abuse)			1						1	Atrial fibrillation; Dizziness; Dyspnoea; Electrocardiogram abnormal; Tachycardia; Urticaria; Atrial fibrillation; Dyspnoea; Electroencephalogram abnormal; Tachycardia; Urticaria	FLU3~SANOFI PASTEUR~DO681AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~00681AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0178617	12/05/2001	NJ	23.0	23		F	11/03/2001	The pt's right upper arm was red, itchy and warm to touch, immediately after flu injection, 9 X 13. Temperature was 98.8F.									Y	11/03/2001	11/03/2001	0		MIL	MIL	Orthocycline; birth control	NONE	NONE			1						1	Injection site erythema; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~0674AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178618	12/05/2001	WY	40.0	40		F	12/03/2001	Pt developed a gross generalized pruritic rash, myalgia, headaches, dizziness and fatigue. All symptoms improved with exception of the rash. Treatments: Symptomatic treatment with Benadryl, Tylenol, several types of ointments/creams, oral steroids and antihistamines.				Y					N	11/14/2001	11/15/2001	1	NONE	PVT	OTH	NONE	NONE	Allergy to Penicillin and latex			1						1	Dizziness; Fatigue; Headache; Myalgia; Pruritus; Rash	FLU3~PFIZER\WYETH~4018030~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0178619	12/05/2001	GA	54.0	54		F	11/08/2001	Pt states she developed redness and swelling at the site of the pneumococcal vaccine, 24 hours, post vax. She was seen at Urgent Care 72 hours, post vax, and treated with steroids and antibiotics. She states that her husband, who received the vaccine on 11/2/01, had a similar reaction and was treated for the same.				Y					Y	10/31/2001	11/01/2001	1		PUB	PUB		NONE				1						1	Injection site erythema; Injection site swelling	FLU3~EVANS VACCINES~AE04851KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1448K~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0178620	12/05/2001	GA	56.0	56		M	11/08/2001	Wife presented to HD stating she saw physician for redness, swelling at pneumococcal vaccine. States husband had same reaction. States husband was treated with steroids and antibiotics just as she was.				Y					Y	11/04/2001	11/05/2001	1		PUB	PUB	UNK	UNK	NKDA			1						1	Injection site reaction; Oedema; Vasodilation procedure	FLU3~EVANS VACCINES~AE04851KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1448K~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0178621	12/05/2001	MN	31.0	31		F	12/03/2001	Severe headache lasting over 24 hours. Very large hard bump on arm from shot.									Y	11/29/2001	11/29/2001	0		PVT	OTH	Birth control and Demulen	NONE	NONE			1						1	Headache; Injection site mass	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178622	12/05/2001	VA	25.0	25		F	11/29/2001	Injection site red, a little swollen and warm (very) to touch, itchy. Taking Benadryl and ibuprofen.									Y	11/26/2001	11/27/2001	1		OTH	PVT						1						1	Injection site hypersensitivity; Oedema; Pruritus; Vasodilation procedure	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178623	12/05/2001	AK	48.0	48		F	11/27/2001	Flu shot, pt noted area of redness over major portion of upper arm including injection site. Described as flat pink, non-tender but itchy, warm. Cleared up by 1 week later. On 11/22/2001 pt diagnosed with flu and noticed that red spot on arm had returned, then disappeared.				Y					Y	10/25/2001	10/26/2001	1		PUB	PUB		NONE	NONE		AK200171	1						1	Drug ineffective; Influenza; Injection site hypersensitivity	FLU3~SANOFI PASTEUR~UO680A7~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178624	12/05/2001	NJ	60.0	60		F	11/29/2001	11:50 Am vaccine given, stated that at 12:30 PM eyes itchy, 2:15 PM presented with face swollen and itchy. No acute distress. Pt's physician uncooperative. given 0.2 epi per MD at 2:30 PM and at 2:40 better and at 4 PM much better. Fine the next day.									Y	11/01/2001	11/01/2001	0		UNK	PVT			Diagnosed with multiple allergies			1						1	Face oedema; Pruritus	FLU3~SANOFI PASTEUR~UO671CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178625	12/05/2001	WY	40.0	40		F	11/30/2001	Severe headache, neck ache, rash upper arms and legs, fever, body aches, erythema at injection site. Starting to recover 11/30 after Benadryl and Vicodin.				Y					Y	11/26/2001	11/27/2001	1		PUB	PVT	Esterase, Synthroid and Fosamax					1						1	Headache; Injection site erythema; Neck pain; Pain; Rash	FLU3~SANOFI PASTEUR~UO707AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178626	12/05/2001	CT	41.0	41		F	11/29/2001	The patient reported progressive numbness from the fingertips on her left hand, to the fingertips on her right hand, to the toes on both feet. The patient experienced a feeling of heaviness in both forearms. These symptoms began 15 minutes after the injection.									U	11/19/2001	11/19/2001	0	NONE	PUB	PVT	NONE	NONE	NONE			1						1	Asthenia; Paraesthesia	FLU3~SANOFI PASTEUR~00608AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178627	12/05/2001	WI	53.0	53		F	11/15/2001	11/13/2001 in the PM, the patient had discomfort in her right arm and hand and felt numb by midnight. The patient awakened in extreme pain and called her MD. The pain is constant down the patient's right arm and she is unable to bend her elbow. The patient was treated with Vicodin and an anti-inflammatory. The patient has pain in the right axillary region, near the anterior scapula.				Y					Y	11/13/2001	11/13/2001	0		PUB	PVT	Paxil, Arthro-7, Calcium, Vitamin E, Multivitamin and alfalfa.		Fibromyalgia.			1						1	Joint range of motion decreased; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U0575AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0690K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0178628	12/05/2001	KS	66.0	66		M	11/20/2001	The patient developed hives on both arms and behind his knees and near the joints. The patient's lip was swollen in the A.M., but the shot may not be related.									Y	11/19/2001	11/20/2001	1		UNK	UNK		NONE	Allergic to mold and pollen.			1						1	Face oedema; Urticaria	FLU3~SANOFI PASTEUR~U0702AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178629	12/05/2001	MI	32.0	32		F	11/28/2001	11/22/2001 post vax, the patient developed fiery erythema, hot to touch, palpable hardness and extreme pruritus of the lateral aspect of the upper arm from the acromiun process to the elbow. On 11/23/2001 the patient experienced body wide pruritus with diffuse, reddened blotchy areas body wide. The patient self-medicated with oral Benadryl. On 11/28/2001 the injection site had a 6cm area of diffuse redness. The patient complained of mild to moderate pain at the injection site. The other symptoms were resolved.									Y	11/21/2001	11/22/2001	1		OTH	PVT	NONE	NONE	NONE			1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Pruritus; Rash maculo-papular; Vasodilation procedure	FLU3~PFIZER\WYETH~U0986011~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0178630	12/05/2001	NH	79.0	79		F	11/29/2001	The patient experienced tremors and chills approximately 4 hours after the vaccination. These symptoms lasted 4 hours. The patient experienced lethargy the following day.									Y	11/21/2001	11/21/2001	0		PVT	PVT	Prinivil, coumadin, thyroid, and Atrovent NS.		Hypothyroidism, fibromyalgia, arthritis and hyperlipidemia.			1						1	Chills; Somnolence; Tremor	FLU3~SANOFI PASTEUR~U0713AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178631	12/05/2001	MI				F	11/28/2001	The patient developed hives/rash over her entire body. This began approximately 1 hour following the injection. The patient was treated with Medrol dose pack, oral Benadryl and Benadryl cream.				Y					Y	11/26/2001	11/26/2001	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~Uj0701AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178632	12/05/2001	IL	34.0	34		F	11/27/2001	The patient stated she developed a rash which spread over her entire body in one weeks time. This started 24 hours after the vaccine was given.				Y					Y	11/12/2001	11/13/2001	1		OTH	PVT		NONE	NONE			1						1	Rash	FLU3~EVANS VACCINES~E02791HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0178633	12/05/2001	NH	25.0	25		F	11/28/2001	The patient was seen for swelling and redness at the injection site 24 hours after the injection. The area of redness was 5cm in diameter. The patient's temperature was 99.6F. The patient was treated with Tylenol and ice.									Y	11/26/2001	11/27/2001	1	NONE	PVT	PVT		NONE	Allergic to Keflex and Bactrim.			1						1	Injection site hypersensitivity; Injection site oedema; Pyrexia	FLU3~SANOFI PASTEUR~U0591CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178634	12/05/2001	NM	43.0	43		M	11/29/2001	The patient developed swelling, fluid build-up and soreness under his left arm. The soreness went away after 48 hours. The swelling lasted for approximately 5 days. The patient took Advil for the first 48 hours.									Y	11/14/2001	11/15/2001	1	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Oedema; Pain	FLU3~SANOFI PASTEUR~U0702AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178635	12/05/2001	TX	25.0	25		F	11/30/2001	Three days post vax, the patient developed left arm and shoulder pain that occasionally radiates to the left hand. The patient was seen on 11/23/2001 by the physician for these symptoms.				Y					Y	11/13/2001	11/16/2001	3		PVT	PVT		NONE	Allergic to amoxicillin.			1						1	Pain; Shoulder pain	FLU3~EVANS VACCINES~E10821LA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0178686	12/06/2001	IL	43.0	43		F	01/09/2002	It was reported that a 43 year old female pt rec'd a Fluzone SV 00-01 vaccination on 12/5/00. Pt developed flu like symptoms (aches, congested and continuous fever). On 12/7/00 the pt was seen in the physician's office. Physician prescribed antibiotics for a week and the symptoms never resolved. The pt began to vomit frequently,. On 12/19/00 she was admitted to the hospital (St Mary's in St Louis). Pt was hospitalized for 3 wks and is now on dialysis 3 times a week. The pt is the reporter and did not believe that her physician ever reported this event. From follow up correspondence received from 1/8/02 the pt's medical history was provided. No further info is anticipated for this report. This case is closed.				Y	Y	21			U	12/05/2000	12/07/2000	2		UNK	UNK			Allergic rhinitis		U2001012100	1						1	Influenza like illness; Nasal congestion; Pain; Pyrexia; Renal failure; Vomiting	FLU3~AVENTIS PASTEUR~UO422AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0178688	12/06/2001	DE	18.0	18		F	11/29/2001	On 11/28/01 at 12:30, the pt was seen at a local ER. Right upper arm with 2 punctures with red lesion at area around injection site. Pt was treated with antibiotics and stayed overnight.				Y	Y	2			Y	11/26/2001	11/28/2001	2	MRI of upper right arm-showed cellulitis below the skin; WBC-24.1; BP-decreased; Resp-increased	MIL	MIL	Pt had 2.5mg Albuterol nebulizer that morning		Asthma			1						1	Cellulitis; Hypotension; Injection site erythema; Respiratory rate increased; Skin ulcer; White blood cell count increased	FLU3~SANOFI PASTEUR~U0679CA~1~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~472209~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0178690	12/06/2001	NJ	90.0	90		F	11/21/2001	Pt awoke 11/15/2001 with hives over entire body. Eyes swollen with feeling of sand in eye check out itchy feeling. Therapy in ER 11/17/01 with Benadryl 25 mg BID and Prednisone 20 mg BID times 3 days. 11/21/2001 rash clear and feeling well.				Y					Y	11/13/2001	11/15/2001	2		PUB	PVT	Prilosec, synthroic, Diabeta, Zoloft	NONE	CHF, hiatus hernia		NJ200124	1						1	Eye swelling; Hypersensitivity; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0572EA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178691	12/06/2001	VA	57.0	57		M	11/29/2001	Redness, swelling at site of Flu shot, painful to impact, low grade, 99 degree temperature, site is warm to touch approximately 3 diameter. Coworker slapped site of shot the next morning.				Y					U	11/26/2001	11/27/2001	1		OTH	OTH	glyburide, ibuprofen	NONE	Diabetic			1						1	Injection site oedema; Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~0699A~1~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178692	12/06/2001	MD	29.0	29		F	11/27/2001	The pt developed dyspnea and wheezing, 10 minutes, post vax. She received IV epinephrine in the ambulance. 25 minutes later, symptoms of airway tightening ceased. No further treatment required. Did not have her inhaler prescription with her.  Follow up 10/07/2002: It was reported that patient developed dyspnea and wheezing 10 minute post vaccination.  Vital signs were stable.  Patient received Epinephrine IV in the ambulance.  Symptoms of airway tightening ceased 25 minutes later.  No further treatments required.  Patient didn't have her inhaler with her at the time.  Seriousness Criteria: Medically Significant.				Y					Y	11/02/2001	11/02/2001	0	NONE	OTH	OTH	PRN inhaler, Zoloft 50 mg/day	getting over viral symptoms	Asthma, hay fever, animal alergies			1						1	Dyspnoea; Wheezing	FLU3~SANOFI PASTEUR~U0694AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178693	12/06/2001	WI	32.0	32		F	11/06/2001	Flu vaccine given 10/05/01, came in 11/5/01 - Check out tenderness, pain at injection site. Area noted to be red/indurated.									Y	10/05/2001				PVT	PVT	Glucophage Diovan, Zestril	NONE	Allergic to PCN only.			1						1	Injection site mass; Injection site pain; Pain	FLU3~SANOFI PASTEUR~U0593AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178694	12/06/2001	CA	9.0	9		M	11/19/2001	Reports raised area around injection site 2 1/2x 3 in diameter. No skin discoloration, no redness or heat.									U	11/19/2001	11/19/2001	0		PVT	PVT		NONE	Allergic to nectarine, dust mitte, berude and rve grass.			1						1	Injection site mass	FLU3~PFIZER\WYETH~4018028~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0178695	12/06/2001	OK	82.0	82		F	11/30/2001	TC from client reporting 2 quarter size erythema places at Flu ing site. Feels well - no other problems reported.									Y	11/27/2001	11/30/2001	3		PUB	UNK						1						1	Rash	FLU3~PFIZER\WYETH~4018024~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0178696	12/06/2001	TN	45.0	45		F	11/19/2001	Nauseated, diarrhea, vomiting.									Y	11/02/2001	11/02/2001	0		OTH	UNK						1						1	Diarrhoea; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178697	12/06/2001	TX				F	10/23/2001	Site of injection red and swollen, approximately 2 cm.									Y	10/09/2001	10/09/2001	0		PUB	OTH						1						1	Hypersensitivity; Injection site oedema	FLUX~UNKNOWN MANUFACTURER~U0599BA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178698	12/06/2001	MD	44.0	44		M	11/27/2001	Chills, shaking, sweating, muscle aching.									Y	11/05/2001	11/06/2001	1		OTH	OTH	Zoloft	NONE	Occasional Depression			1						1	Chills; Hyperhidrosis; Myalgia; Tremor	FLU3~SANOFI PASTEUR~U0694AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178699	12/06/2001	TX	50.0	50		F	11/12/2001	Pt states next day after injections of Flu vaccine and pneumo vac had 105 degree fever orally, did not go to ER or call provider. Each day thereafter fever decreased and local reaction at site of injection, left arm redness and swelling per patient. Pt states recovered completely. Pt stated had chills and sweating also.									Y	10/31/2001	11/01/2001	1		PUB	UNK		NONE	RSO, Hypertension, COPD			1						1	Injection site oedema; Injection site reaction; Pyrexia; Vasodilation procedure	FLU3~SANOFI PASTEUR~U0682AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~474936~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0178725	12/07/2001	CA	43.0	42		F	11/27/2001	Red sore and swollen left arm area reported to ES on 11/21/01. Treated for cellulitis left arm within  hours after 500 mg by mouth. Cold at forearm 11/27/01 pt reports finished medication and No problems.				Y					Y	11/19/2001	11/21/2001	2		UNK	UNK						1						1	Cellulitis; Oedema; Vasodilation procedure	FLU3~PFIZER\WYETH~U008223~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0178726	12/07/2001	NJ	44.0	44		M	12/03/2001	Check outfeeling dizzy, blurring vision, blood pressure systolic=80 (Pre Vaccine B/P 142/92). Slight chest pressure. Epinephrine ADM, 911 notified, transported to RWJ, evaluated and discharged.				Y					Y	11/21/2001	11/21/2001	0		OTH	OTH	Epinephrine	NONE	Denied, Reference Consent Form			1						1	Amblyopia; Chest pain; Dizziness	FLU3~SANOFI PASTEUR~U0683CA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178727	12/07/2001	PA	58.0	58		F	12/13/2001	Pain, swelling in upper arm. Pain, numbness in left 5th finger (1 day after injection. Still persisting on day four.									N	11/29/2001	11/30/2001	1		PVT	PVT	Premarin, Prevacid	NONE	None except arthritis, lumbar spine			1						1	Oedema; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U0713AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178728	12/07/2001	PA	38.0	38		F	11/30/2001	Right leg weakness, pain, tingling in right foot. Physical therapy started and continues to present time. Symptoms continue.				Y					N	10/18/2001	10/26/2001	8		PVT	OTH	Vioxx, Robaxin, Darvon 100	NONE	Celiac disease, Codeine, Percodan, Sulfa drug, allerged.			1						1	Myasthenic syndrome; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U0680AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178729	12/07/2001	WI	55.0	55		F	11/26/2001	At 1700, 11/09/01, Left arm , feet, hand and 30 later knee circle around arm then red and swollen, also chills times 2 days after within one eprsoal diarrhea, (amps).									U	11/09/2001	11/09/2001	0		PVT	OTH	Multi Pie, tegretal, tylenal, iburafen, barium, amitriptyeline, seafood	NONE	Multipie also cramp x 1 Rt/LT foot. tah, BSO nervous- R/o anxiety, possible COPD(1995) HTN			1						1	Injection site oedema; Vasodilation procedure	FLU3~SANOFI PASTEUR~U067DA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1043L~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0178759	12/10/2001	OR	59.0	58		M	11/19/2001	Pt got the flu shot on 11/2/01. A couple of days later, he felt joint aches and was feeling bad. On 11/13/01 at 14:00, he began to feel numbness and tingling in his feet and hands. Also was losing coordination. GBS? Still in ICU. 60 day follow-up information states on 1/21/03 T.V. with medical RN and client.l Under care of neurologist for GBS which occurred 2 weeks after flu vaccine 11/2/01. On Soc Sec because uncalbe to return to job as machinist. Able to ambulate now without care. Very fatigued/no stamina, feet hypersensitive and sore; numbness and tingling in fingers and left side of face and forehead. Discharge summary states GBS, sepsis, and URI. Follow up on 11/04/2003: Vaccine recipient did not recover from the adverse event.  See attached updated report based on 10/30/2003.  Telephoned client regarding her present health states and treatment.				Y	Y	60			U	11/02/2001	11/13/2001	11	CSF fluid with increased protein.	OTH	PVT	NONE		Discharge summary indicates pt has history of smoking/tobacco addiction.		OR200147	1						1	Arthralgia; CSF test abnormal; Coordination abnormal; Fatigue; Feeling abnormal; Guillain-Barre syndrome; Paraesthesia; Sepsis; Urinary tract infection	FLU3~SANOFI PASTEUR~UO688AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0178760	12/10/2001	NY	63.0	63		M	11/28/2001	Received flu vaccine on 11/16/2001. One hour and a half later began sweating, swelling in armpit (size of baseball), shaking, no pain, indigestion, weakness, laying on floor. Called doctor 3 hours after receiving vaccine was in hospital for heart attack.					Y	11			Y	11/16/2001	11/16/2001	0		PUB	PUB	Allergy shots	NONE	Allergies: mold, spores, dust and animals			1						1	Asthenia; Dyspepsia; Hyperhidrosis; Myocardial infarction; Oedema	FLU3~EVANS VACCINES~E10801LA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0178762	12/10/2001	UT	33.0	33		M	11/15/2001	Patient accidently received anthrax vaccine 5 months sooner than he was suppose to, no reported adverse effects up to this point 11/15/01.									Y	11/14/2001				MIL	MIL						1						1	Unevaluable event	ANTH~EMERGENT BIOSOLUTIONS~FAV048B~5~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U0704AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178763	12/10/2001		77.0	77		F		The pt received the influenza vaccine on 11/3/98 and 11/4/00 without incidence. The pt was dx'd with breast cancer in 1980, which is currently in remission. For the treatment of this cancer, the pt has for years been taking raloxifene Hydrochloride and megestrol acetate orally on a po basis. The pt has also, for an unspecified period, been taking hydrochlorthiazide orally on a PO QD basis, for the treatment of hypertension. On 11/20/01, the pt experienced constriction of the mouth and difficulty swallowing. On 11/21/01, the pt was seen by a physician, was dx'd with Bell's Palsy and Prednisone was prescribed with some improvement. On 11/27/01, the pt was seen by her regular physician for follow-up. The dx of Bell's Palsy was again confirmed as the pt presented with lip drooping, however, swallowing had improved. Prednisone for an additional 2 weeks, was prescribed. The reporter has assessed the relationship of Fluvirin to the event as possible. This was considered to be an Other Important Medical Event.									U	10/30/2001	11/20/2001	21		UNK	UNK	E-vista; Megace; Dyazide		Breast cancer in 1980		PJP2001004360	1						1	Dysphagia; Facial palsy	FLU3~EVANS VACCINES~E09881LA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0178764	12/10/2001	IL	35.0			M	11/27/2001	2 1/2 hours after receiving Adult Hep B + Influenza Vaccine at work developed chest pain, flushing, nausea and increased heart rate. Sent to Freeport Hospital ER. All tests were normal.				Y					Y	11/12/2001	11/12/2001	0		PUB	PVT						1						1	Chest pain; Nausea; Tachycardia; Vasodilation procedure	FLU3~SANOFI PASTEUR~UO671DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SMITHKLINE BEECHAM~5255A6~2~IM~RA~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0178765	12/10/2001	KS	58.0	58		F	11/12/2001	Pt called 7 days within  flu shot voiced that she had a rash all over her body.									Y	11/08/2001	11/08/2001	0		PUB	OTH	Actos 15 mg QD, Accupil 10 mg QD		Feline			1						1	Rash	FLU3~SANOFI PASTEUR~U0672AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178766	12/10/2001					F	11/30/2001	Hospital employee received routine influenza vaccine immediately started swelling with red rash.				Y					Y		11/26/2001			UNK	UNK						1						1	Injection site oedema; Vasodilation procedure	FLUX~UNKNOWN MANUFACTURER~4018033~6~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0178767	12/10/2001	IA	65.0	65		F	11/30/2001	About 5 hours after shot, arm hot and arm hot to touc. By the next day pt had 4 circumference of redness, swelling, hot and itchy. Today area of redness has decreased to about 3 redness. Says she has reacted to flu shots other years. Currently gets allergy shots from Clinic in Cedar Rapids. Sometimes reacts to those.									Y	11/27/2001	11/27/2001	0		OTH	PVT	NONE	NONE	Taking allergy shots; Diabetes			1						1	Hypersensitivity; Oedema; Pruritus; Vasodilation procedure	FLU3~SANOFI PASTEUR~U0596AA~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178768	12/10/2001	WI	60.0	60		M	12/03/2001	3rd cranial nerve palsy to L eye. Drooping lid. Burning eye, socket pain - severe. Watery eye. Seen by 5 ophthalmologist no treatment. Prognosis 3-6 months with 100% return of eye function & sight. Also have distorted vision that causes nausea.					Y	7			Y	10/12/2001	10/22/2001	10	MRI	OTH	OTH	Prilosec, ASA, insulin	NONE	Diabetes			1						1	Eye disorder; Eye pain; Lacrimation increased; Paralysis	FLU3~SANOFI PASTEUR~U0670AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0178769	12/10/2001	NY	54.0	54		F	12/03/2001	Received shot and W/H KeD to intake area my whole arm became numb, I felt dizzy and sat down, I felt faint and put my head on the desk. I started sweating, shaking and my heart started racing. When I started to come out of it, I felt weak, tired and shaky. I went home and slept for 2-3 hours took Advil for aches and headache behind my eye.									Y	11/30/2001	11/30/2001	0		PUB	PVT	Avalide, Atenolol	NONE	Hypertension			1						1	Asthenia; Orthostatic hypotension; Paraesthesia; Syncope; Tremor	FLU3~PFIZER\WYETH~4018043~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0178770	12/10/2001	OK	68.0	68		F	11/30/2001	11/30/01 telephone call from pt saying that she began to get a rash the evening of 11/27/01 the day she got her flu and pneumonia shots. The rash is now all over her body and is itchy. She also reports erythema at the injection site. Has had several flu shots in past without problems. Advised to contact private physician re anti pruritic.									U	11/27/2001	11/27/2001	0		PUB	PUB						1						1	Injection site erythema; Rash	FLU3~PFIZER\WYETH~4018024~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0945K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0178771	12/10/2001	TX	60.0			F	10/23/2001	Arm very sore and red									Y				NONE	PUB	OTH	Premarin					1						1	Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U0599BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178772	12/10/2001	OH	23.0	23		F	11/29/2001	Pt states that at 9pm 11/28/01 she broke out in hives, which started at the injection site & spread all over her body. By 11pm she was itching all over. At 2am 11/29/01 she put cortisone cream & alcohol on for relief of itching. Presented to H.D. at 1:45pm 11/29/01.No rash at present has had flu vaccine x last 5 yrs annually.				Y					Y	11/28/2001	11/28/2001	0		PUB	PUB		NONE	NONE			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0698AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178773	12/10/2001	PA	33.0	33		F	12/04/2001	Severe pain, induration erythema myalgias localized left UE +shoulder +chest pain, mild pruritis. Pain swelling extended from deltoid to pectoral trapezius axillary distrubtion, lymphadenopathy  within 24 hours									Y	11/29/2001	11/29/2001	0	NONE	PVT	PVT	NONE	NONE	Aspirin Allergy,Asthma			1						1	Chest pain; Injection site erythema; Injection site hypersensitivity; Injection site induration; Injection site pain; Lymphadenopathy; Myalgia; Pruritus	FLU3~SANOFI PASTEUR~UO213AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~10456~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0178774	12/10/2001	SC	33.0	33		F	11/30/2001	Soreness injection site, fever 102, 5:30-6 PM took two Goody Powders. Muscle aches up and down arm, joint pain left arm numbness and tingling fingertips developed night of injection and next day. 11/30/2001 symptom free.									Y	11/28/2001	11/28/2001	0	NONE	OTH	PUB	BCP	Healthy			SC0160	1						1	Injection site pain; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~UO673GA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178775	12/10/2001	SC	43.0	43		F	11/30/2001	One hour after flu shot given developed burning in throat, reacted to BA did not report until 12/21/2000. 11/19/2001 came for flu shot, states tongue also swelled, difficulty after flu shot 12/2000. no flu shot give 11/2001.									Y	12/01/2000	12/01/2000	0	NONE	OTH	PUB		NONE	Allergy: penecillin, sulfa, mutt foods and latex		SC0162	1						1	Oedema; Pharyngitis	FLU3~AVENTIS PASTEUR~UO439DA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178776	12/10/2001	OR	22.0	22		F	12/04/2001	Red welt developed. 4.5 cm by 6 cm, No treatment administered.									Y	11/20/2001	11/22/2001	2	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Urticaria; Vasodilation procedure	FLU3~SANOFI PASTEUR~UO699AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178777	12/10/2001	DC	44.0	44		F	12/06/2001	Pt received flu vaccine about 2 weeks ago, in the right deltoid. The deltoid pain began about 24 hours, post vax. In the past 2-3 days, she had increased pain, limited use of her shoulder, arm and hand. No erythema, inflammation, induration, masses or lesions. Positive abduction was limited to 45 degrees. Treatment: conservative; ibuprofen and cold therapy. Return if signs and symptoms increase or persist over 5-7 days.									U	11/19/2001	11/20/2001	1	NONE	OTH	PUB	NONE	NONE	Allergy to aspirin; history of anemia (1996)			1						1	Injection site pain; Joint range of motion decreased	FLU3~SANOFI PASTEUR~U0699AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178778	12/10/2001	PA	41.0	41		F	11/28/2001	Pt is having progressive numbness and weakness of left side of body including her tongue. Pt has been sent to neurologist. There is concern the pt may have Guillain Barre. Pt is in the process of treatment. FU on 12/3 from MD states pt is somewhat anxious and has some give away weakness in her legs as well as astasia abasia when walking. Will start her on steriods and ask her to come back in after getting test results. Diagnosed with acute disseminated encephalomyelitis				Y					N	11/14/2001	11/16/2001	2	MRI done on 12/3/01; cervical spine MRI 12/4/01.	OTH	OTH	OTC Estroven MSAN		Allergic to PCN			1						1	Anxiety; Asthenia; Coordination abnormal; Encephalitis; Guillain-Barre syndrome; Muscular weakness; Paraesthesia	FLU3~SANOFI PASTEUR~UO688AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178779	12/10/2001	UT	55.0	55		M	11/13/2001	Nerve pain associated with area where flut shot given. Sharp, prickly pain when use arm when lifting. Pain lasted for about 3 weeks. Took ibuprofen 600 mg intermittently.									Y	10/24/2001	10/24/2001	0		OTH	PVT	Adalat, Amaryl, Toprol, Zocor and Zestoretic	NONE	Diabetes and high blood pressure			1						1	Neuralgia	FLU3~SANOFI PASTEUR~UO598AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178780	12/10/2001	TX	50.0	50		F	11/29/2001	Redness at site with edema and warm to touch X 2-3 days. Dizziness for 10 minutes, post vax. Rash at site X 3 days with itching. Complete recovery.									Y	11/09/2001	11/09/2001	0		PVT	PVT	E-Vista; HRT	NONE	Allergy to Vicodin			1						1	Dizziness; Injection site erythema; Injection site swelling; Injection site warmth; Pruritus; Rash	FLU3~SANOFI PASTEUR~U0685AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178781	12/10/2001	FL	39.0	39		F	12/04/2001	Vaccine administered into top of arm at shoulder location. Extreme pain radiating into and down the arm. Doctor said it possibly hit the bone and/or nerve. Improperly given.				Y					N	12/04/2001	12/04/2001	0		OTH	UNK		NONE				1						1	Pain	FLU3~SANOFI PASTEUR~UO598AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178782	12/10/2001	IL	81.0	81		F	11/27/2001	States day after immunization arm very sore and swollen. remains painful, teking Tylenol every two time a day. Talked to nurse at MD's office. Told to use warm compresses. Pain (2 weeks later) from site of immunization to elbow.										10/30/2001	10/31/2001	1		PUB	PUB	Premarin, Synthroid, Verapamil, Liptor and Imdur	NONE	Heart problems, high thyroid and high cholesterol.			1						1	Oedema; Pain	FLU3~SANOFI PASTEUR~UO596DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178783	12/10/2001	OR	23.0	23		M	11/14/2001	10 minutes, post vax, the pt reported vision changes, weakness, shakiness but was coherent and oriented. He then became diaphoretic, pale and required assistance from local EMT's. He was transported to the local hospital and given fluids. He recovered.				Y					Y	11/09/2001	11/09/2001	0	NONE	OTH	PUB	NONE	NONE	NONE		OR200148	1						1	Asthenia; Hyperhidrosis; Pallor; Tremor; Visual disturbance	FLU3~PFIZER\WYETH~4018030~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0178784	12/10/2001	TX	39.0	39		F		Pt developed pain at the injection site. It was raised, red with chills and glands swollen X 5 days. Resolved now.									Y	11/09/2001	11/10/2001	1		PVT	PVT	Lodine 600mg; Synthroid; OC's	NONE	Thyroid failure			1						1	Chills; Injection site erythema; Injection site pain; Injection site swelling; Lymphadenopathy	FLU3~SANOFI PASTEUR~U0685AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0923L~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0178785	12/10/2001	SC	69.0	69		F	11/15/2001	Second arm felt sore Sunday. Six days later pt states felt tightness around muscle. Pt describes light red circle around muscle 10 day later. Pt also states pain extended down arm and into back and neck. Pt states will see private MD on 11/17/2001 for evaluation. Red circle nickel size around injection site today. Pt took 5 days of Amoxicillin.				Y						10/29/2001	10/30/2001	1		PUB	UNK			Arthritis, scoliosis, pulled chest muscle			1						1	Injection site hypersensitivity; Myalgia; Vasodilation procedure	FLU3~SANOFI PASTEUR~UO673BA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178097	12/11/2001	MI	49.0	49		F	11/07/2001	Symptoms: 10/26/2001 Woke up with chest pains (all over) with sore throat. No fever, lasted 3 days. Three days later developed coughing, sore throat, hot and cold , T 100, no aches. Took Tylenol Cold OTC for five days, saw MD 11/07/2001.				Y					Y	10/25/2001	10/26/2001	1	NONE	PUB	UNK	Tenormin, Dyazine and Lescol		Hypertension and high cholesterol		MI2001091	1						2	Cough; Pain; Pharyngitis; Pyrexia; Chest pain; Cough; Pharyngitis; Pyrexia; Vasodilation procedure	FLU3~SANOFI PASTEUR~U0684AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~UO684AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0178836	12/11/2001	MN	48.0	46		F	12/06/2001	Upon waking, on 11/12/99, the pt experienced both legs buckled and had difficulty walking. Symptoms progressed by evening and was unable to stand. By the next day, she loss use of her arms and hands. Treatment (IV solution of platelet Ig concentrate) started immediately with some return of feeling in a week. Went to inpatient after 11 days in ICU. She is using walker. Fully recovered and back to work on 3/1/00. She felt self again in 5/01.				Y	Y	27			Y	10/12/1999	11/12/1999	31		PUB	UNK	NONE	Polyneuritis/paralytic ileus	NONE			1						1	Difficulty in walking; Muscular weakness	FLU3~PFIZER\WYETH~4998223~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0178837	12/11/2001	IL	71.0	72		F	12/05/2001	Reported pt diagnosed with Guillain-Barre syndrome. Per 1 year ago: Pt has not recovered. Continues to be off-balance. Bottoms of my feet are painful and they tingle with my toes wanting to draw under. My hands still tingle.				Y	Y				U	10/25/2001	12/01/2001	37		PUB	PUB			UNK			1						1	Balance disorder; Guillain-Barre syndrome; Pain in extremity; Paraesthesia	FLU3~SANOFI PASTEUR~UO590AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0178841	12/11/2001	MI	86.0	86		M	12/03/2001	120x70 mm hematoma on right arm area. No soreness, no numbness or tingling of extremity area dark purple with yellowing with edges. To flu with pink in 1-2 days.									Y	11/26/2001	12/01/2001	5		PUB	PVT	Blood pressure medication		HTN		MI2001094	1						1	Haemorrhage; Skin discolouration	FLU3~PFIZER\WYETH~4018045~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0178842	12/11/2001	OH		39		F	12/04/2001	Check out swollen area on arm.										11/30/2001	12/03/2001	3		OTH	PVT		NONE	NONE			1						1	Injection site oedema	FLU3~SANOFI PASTEUR~U0708AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178843	12/11/2001	OH	70.0	70		F	12/03/2001	The pt complained of soreness, swelling and redness on left arm between elbow and upper arm the day after injections.									Y	11/27/2001	11/28/2001	1	NONE	OTH	PUB	NONE	NONE	NONE			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U0703AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1351J~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0178844	12/11/2001	IL	59.0	59		F		The pt complained of soreness at the site of the injection. She called on 12/31/01 and said that she had difficulty in raising her arm. She was vaccinated on 11/7/01.									U	11/07/2001	11/09/2001	2		OTH	PVT	NONE	NONE	NONE			1						1	Hypokinesia; Injection site pain	FLU3~SANOFI PASTEUR~U0681AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178845	12/11/2001	WI	57.0	57		F	11/30/2001	11/1/01 pt reported having a light red rash all over her body. Dry rash.									Y	10/28/2001	11/01/2001	4	NONE	PUB	PVT	Claritin, Prilosec, inhalers, hormones	cold 1 wk prior	sulfa, animal dander, pollen, dust mites			1						1	Rash	FLU3~SANOFI PASTEUR~U0591EA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178846	12/11/2001	NC	50.0	50		F	11/27/2001	The pt experienced a syncopal episode about 15-20 minutes after flu shot and about 5 minutes after blood was drawn complicated by difficulty accessing vein X 3 attempts. The pt felt dizzy prior to episode. The event was attributed to vasovagal reaction.									Y	11/05/2001	11/05/2001	0	NONE	PVT	PVT	Salogen; Plaquenil; Augmentin; Excedrin	Sjorgen's Syndrome	UTI; Type II Herpes Simplex; Toxoplasmosis; Chronic HA			1						1	Dizziness; Syncope	FLU3~EVANS VACCINES~E06741LA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0178847	12/11/2001	MI	21.0	21		M	12/03/2001	Rash, itching muscle aches, fatigue.				Y					Y	11/29/2001	11/29/2001	0		OTH	PVT		NONE	NONE			1						1	Asthenia; Hypersensitivity; Pain; Pruritus; Rash	FLU3~SANOFI PASTEUR~U0714AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178848	12/11/2001	MS	54.0	54		M	11/06/2001	The pt called the clinic on 11/6/01 and stated he has had stiff neck and soreness of head and ears since 11/3/01. He states he has arthritis of neck and he was referred to PMD. Called PMD but the pt did not go. Then PMD's office called and stated the pt was seen on 11/3/01 with no complaints.				Y					U	11/02/2001	11/03/2001	1		PUB	PUB		NONE	NONE		MS01053	1						1	Arthritis; Ear pain; Headache; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U0698AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178849	12/11/2001	CA	48.0	48		F	11/28/2001	11/28/01 @ 1:35 came in for swollen,painful L arm after flu shot. Ice packs and advil tabs po q 6 hrs, prn. 12/3/01 pt called, doing fine now.									Y	11/07/2001	11/28/2001	21	NONE	OTH	OTH		NONE	asthma, migraine			1						1	Injection site pain; Injection site swelling	FLU3~PFIZER\WYETH~4018049~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0178850	12/11/2001	MD	31.0	31		F	12/04/2001	Stiff neck, 11/20/2001, 6PM, 9:00AM awaking 11/21/01 vasculitis lower extremity (legs), stiff neck, headache, cold, by 11/25/01 on forearms, buttocks, stomach, lower back, but spoatic, 11/29/01 3 painless ulcers in roof of mouth.				Y					Y	11/13/2001	11/20/2001	7	Blood test to rule out SLE.	OTH	OTH	Elavil (25 mg) headache prevention, Levelin	NONE	NONE			1						1	Arthropathy; Chills; Headache; Mouth ulceration; Vasculitis	FLU3~SANOFI PASTEUR~U0699AA63002~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178851	12/11/2001	CA	1.4	1	.5	M	12/03/2001	Seven minute tonic-clonic seizure. No documented fever. Twin sibling has had 2 febrile seizures.				Y					Y	11/27/2001	11/29/2001	2	CBC-wnl, lytor, LP, head CT	PVT	PUB		Resolving otits media				1						1	Convulsion	FLU3~SANOFI PASTEUR~UO688AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0782L~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0178852	12/11/2001	HI	45.0	45		F	10/17/2001	Received influenza vaccine 10/15/2001 left upper arm. Same evening painful, warm to touch. Next day 10/16/2001 large reddened, hardened raised area 10/17/2001. Some reddened area not raised 2 inches in diameter. Took Tylenol.									Y	10/15/2001	10/15/2001	0	NONE	PUB	PVT	Premarin	NONE	Allergy-Bees			1						1	Hyperaesthesia; Pain; Rash maculo-papular; Vasodilation procedure	FLU3~SANOFI PASTEUR~U0573AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178853	12/11/2001	NE	68.0	68		M		Pt received vaccine on 10/24/2001 in AM. That evening pt experienced increased intestinal and bladder pressure for 2 days with chills, after which symptoms resolved.									Y	10/24/2001	10/24/2001	0	NONE	PUB	PVT						1						1	Chills; Sensation of pressure	FLU3~SANOFI PASTEUR~UO595AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178854	12/11/2001	NH	61.0	61		M	12/03/2001	Received flu shot left deltoid 11/15/2001. On 12/03/2001 complained of weakness in arm, difficulty raising arm, decreased strength. Saw ARNP 11/26/2001. Treated with warm compress. NKA. On 12/06/2001 improved.				Y					Y	11/15/2001	11/26/2001	11		PUB	PVT	NONE	NONE	NONE			1						1	Asthenia; Joint range of motion decreased	FLU3~SANOFI PASTEUR~60703AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178855	12/11/2001	NH	28.0	28		F	12/03/2001	Pt developed chest and throat tightness about 8 minutes after receiving flu vaccine. Epinephrine 0.3cc given.				Y					Y	11/29/2001	11/29/2001	0		PUB	PVT		NONE	NONE			1						1	Chest discomfort; Throat tightness	FLU3~SANOFI PASTEUR~UO703AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178856	12/11/2001	OH	43.0	43		F		Complained of red mark, hot area of upper arm, area is black and blue and swollen the size of a fist.									Y	12/04/2001			NONE	OTH	PVT	NONE	NONE	Esophageal reflux			1						1	Contusion; Injection site hypersensitivity; Oedema; Vasodilation procedure	FLU3~SANOFI PASTEUR~40708AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178857	12/11/2001	MI	4.0	4		F	11/30/2001	Cellulitis of left thigh. Benadryl PO q 4-6 hours. Keflex 250 mg TID for 7 days. Warm soaks.				Y					Y	11/26/2001	11/26/2001	0	NONE	PVT	PUB	Takes Creon with meals	NONE	Cystic Fibrosis			1						1	Cellulitis	DTAP~GLAXOSMITHKLINE BIOLOGICALS~513A2~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UO71AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~T1128~4~SC~RL~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0736L~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0178858	12/11/2001	FL	45.0	45		F	12/05/2001	1:30 AM woke up nauseated, vomited, had diarrhea. Continued for 2 weeks. 11/15/2001 IV for dehydration-NS. Continues to be dizzy and complains of nausea.				Y					N	10/30/2001	10/31/2001	1	CBC-wnl; Comprehensive metaboli profile-wnl	PVT	PVT	Multivitamin with iron	NONE	Blurred vision, dizzy spells. lesion, frequent headaches			1						1	Dehydration; Diarrhoea; Dizziness; Nausea; Vomiting	FLU3~SANOFI PASTEUR~UO691AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178859	12/11/2001	MI				M	12/06/2001	Allergic dermatitis and flu-like symptoms.									U	12/05/2001	12/06/2001	1		OTH	PVT		NONE	NONE			1						1	Dermatitis allergic; Influenza like illness	FLU3~SANOFI PASTEUR~UO714AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178860	12/11/2001	IL	75.0			M		The pt presented to my office quite unexpectedly on 11/20/01 with complaints of worsening ecchymosis and bleeding from his mouth and nose. A stat CBC showed a platelet count of 8,000. Two weeks earlier, his platelets were stable at 68,000 while on Danocrine 200mg daily and prednisone, 5mg daily. In taking a history from the pt, the only thing new was the fact that he had received an influenza vaccination approx. 2 weeks earlier. What was quite fascinating was the fact that the day before, another pt of mine with a history  of ITP, also presented to my office with a relapse of his disease 12-14 days after an influenza vaccination. I took the liberty of treating the pt with high dose IG IV, I raised his dose of prednisone, gave him 1 dose of Vincristine and 2 units of platelet transfusion because of his bleeding. On 11/27/01, his platelet count was still low at 6,000. He then received a dose of WinRho as an outpatient on 11/27/01. On 11/29/01, his platelets were still low. Test showed elevated Transaminases of uncertain etiology which could certainly be due to the Danocrine or to perhaps the WinRho. I will ask the pt to discontinue the Danocrine at this time and raised his prednisone to 80mg/day. Platelets were up to 40,000 on 12/3/01. In 17 years of practice, I have never seen this. This is considered to be an Other Important Medical Event.				Y					Y		11/20/2001		Chronic ITP	OTH	OTH		CBC-8,000 and 6,000	Chronic ITP			1						1	Aspartate aminotransferase increased; Ecchymosis; Epistaxis; Mouth haemorrhage; Platelet count decreased; Thrombocytopenic purpura	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0178861	12/11/2001	OH	5.0	5		M	11/29/2001	Mother of child states 11/15 size of a dime large lump with redness developed on R arm at injection site. It continued to increase in size on 11/16 became very warm to touch 3 large half dollar size blotches were present. 11/17 began to resolve and now completely gone without further complications.									Y	11/14/2001	11/15/2001	1		PUB	PUB	NONE	NONE	NONE		OH0070	1						1	Injection site erythema; Injection site mass; Injection site warmth	FLU3~SANOFI PASTEUR~U0597AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~1456K~1~IM~RA~PNEUMO (PREVNAR)~1	USA		Influenza
0178906	12/12/2001	OR	36.0	36		F	12/05/2001	Pt phoned emp hlth the last wk of 11/28/01 to report hx of possible adverse reaction post receiving vaccine 10/27/01 - states 20 min post injection had local reaction @ site within 2 hrs had back pain, spine at tailbone pain. Also notes funny taste in mouth. 11/9/01 had SOB & nausea. Tx in ER 11/14/01 for N&V. Admitted to hospital with tachycardia x 2 days 11/17/01, discharged home - has not worked since 11/12/01.				Y	Y	2			U	10/29/2001	10/29/2001	0		PVT	UNK	Synthyroid, Pepcid,Valium, Soma, Indocin, Imitrex	UNK	GERDs, Migraine & tension headache, Hx of backpain, etiology unknown, Hx of arthralgia			1						1	Back pain; Dysgeusia; Dyspnoea; Injection site reaction; Nausea; Tachycardia; Vomiting	FLU3~SANOFI PASTEUR~UO571AD~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0178908	12/12/2001	AZ	78.0	78		M	12/04/2001	Pt presented with a week's history of progressive weakness from the legs ascending up   into the upper arms and chest prior to admission. Pt rec'd influenza vaccination about 10 days prior to the onset of symptoms. 2 days prior to his admission, he was not able to get out of bed secondary to the weakness .Lumbar puncture was performed and this was unremarkable, as was MRI of the brain. It was felt that the pt likely had Guillain-Barr syndrome and was started on  plasmapheresis.				Y	Y	25			Y	10/02/2001	10/08/2001	6	Multiple labs performed	PVT	UNK	Coreg, Pyridoxine, Sodium bicarbonate, tums, Magnesium oxide, Glipizide, Albuterol nebulizer treatments, multivitamin.		cardiomyopathy, diabetes mellitus type 2, chronic insufficiency, paraesthesias in feet			1						1	Asthenia; Guillain-Barre syndrome	FLU3~SANOFI PASTEUR~U0592AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0178909	12/12/2001	AZ	79.0	79		M	12/04/2001	Rheumatology Consultation: Pt developed new onset lower extremity muscle weakness and knee pain. Gait was quite wobbly. Pt states this has been progressive over the past week and was admitted two days ago when he presented to the ER for further evaluation. Pt reports knee pains at night which have been quite painful and he describes this as aching but is not particularly bothered during the day. Pt reports some constipation over the past week.Marked weakness of the quadriceps and biceps femoris muscles bilaterally. Other possibilities include Amiodarone - induced neuromyopathy. Renal consultation: over the course of this hospitalization his symptoms have worsened and full evaluation is consistent with Guillain-Barre. I am being consulted for initiation of plasmapheresis. Pt developed the onset of some orthostasis and weakness, symptoms have progressed to marked proximal and distal lower extremity weakness. Pt has noted some paresthesia of his hands ad increasing weakness of his lower extremities. He finds it extremely difficult at this time to get out of bed. It is agreed the pt should be initiated on plasmapheresis. We will arrange to get a subclavian or IJ line placed for plasmapheresis and will use one plasma volume exchange replacing with albumin. Currently he has no evidence for marked pulmonary involvement. We will follow his FVC's. Per 1 year follow up: Pt has recovered.				Y	Y				U	11/08/2001	11/22/2001	14	white count 8400, hemoglobin 12.5, platelet count 295,000. glucose 112,TSH 1.36, CPK less than 20, pro time 2.11, PTT 71.8, sedimentation rate 92. MRI of the head showed small vessel ischemic changes along with ethmoid and maxillary sinusitis. X-ray of the knees were read as showing moderate degenerative findings. Chest x-ray showed no acute changes. CT  scan of the head showed no acute changes. MRI of the lumbar spine is pending. 12/2/01 INR 1.43, pro-time 17.7, CSF protein 112, gram stain negative. glucose 65, cell count unremarkable. 11/29/01 WBC count 8.4, hematocrit 36.6, BUN and creatinine are 16 and 0.9, respectively. Potassium 4.7, urinalysis was negative dipstick on admission.	OTH	OTH	Amiodarone, diltiazem and Coumadin, Asacol, Flomax, tylenol, Vicodin		Organic heart disease with a history of mitral valve prolapse for 8 to 10 years; new onset a couple of weeks ago with atrial fibrillation; non-Hodgkin's lymphoma 2 years ago; benign prostatic hypertrophy treated for the past 5 to 10 years; irritable bowel for 5 years; bilateral inguinal herniorrhaphies 35 years ago; eczema on the feet for many years; benign prostatic hypertrophy			1						1	Arthralgia; Constipation; Gait disturbance; Guillain-Barre syndrome; Laboratory test abnormal; Muscular weakness; Paraesthesia; Pneumonia; Respiratory disorder; Guillain-Barre syndrome; Respiratory distress	FLU3~EVANS VACCINES~E04851KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0178910	12/12/2001	FL	65.0	64		F	12/04/2001	Redness, swelling at least 70mm.									U	11/30/2001	11/30/2001	0	N/A	UNK	UNK	Albuteral, Atrovent ,azmacort, vit E,	NO	elevated BP/Ashtma			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U067909~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1160L~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0178911	12/12/2001	NY	54.0	57		F	11/20/2001	Pt developed pain and difficulty  with movement of left shoulder. Pain radiates down shoulder to lower arm. Had decreased range of motion with abduction and rotations.									N	11/01/2001	11/03/2001	2	Myopathy. CBC and CPK-wnl	PUB	OTH			NONE			1						1	Joint range of motion decreased; Myopathy; Pain	FLU3~SANOFI PASTEUR~UO670AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178912	12/12/2001	CA	33.0	33		F	12/15/2001	Red, swollen, warm to touch 45 mm X 35 mm.									Y	12/04/2001	12/05/2001	1		PVT	PVT		NONE	NONE			1						1	Oedema; Vasodilation procedure	FLU3~SANOFI PASTEUR~U0699AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178913	12/12/2001	MD	58.0	58		M	12/07/2001	Cellulitis of R upper arm, bursitis of R elbow, low grade fever. Redness evening of vaccine within 24 hrs of vac. Rx duracef 1gm x 2 days 500mg BID x 8 days 12/12 - feeling much better.				Y					Y	12/04/2001	12/04/2001	0	NONE	PUB	UNK	NONE	NO	Hay fever			1						1	Bursitis; Cellulitis; Injection site erythema; Pyrexia	FLU3~SANOFI PASTEUR~U0591CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1071K~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0178914	12/12/2001	UT	38.0	38		F	12/04/2001	1215 flu vac, 1225 complained of swelling arm, SOD, to chest. Benadryl 15 mg.				Y					U	12/04/2001	12/04/2001	0		OTH	OTH	Benadryl, Nofpi	Lupus only				1						1	Oedema	FLU3~PFIZER\WYETH~L1018027~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0178915	12/12/2001	IL	6.0	6		F	12/07/2001	Erythema of 5x8cm. Lump, mild warmth and swelling developed in R upper arm at site of flu vaccine.									Y	12/04/2001			NONE	PVT	PVT	Albuterol, Flovent	Upper respiratory infection	H/O raw eggs touched face got hives.			1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U0708AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178916	12/12/2001	PA	46.0	46		F	12/06/2001	Pt rec'd flu shot L upper extremities and developed fever to 104F, chills and a severe cellulitis VS allergic reaction requiring admission to hospital. WBC count of 25  15x7cm area of induration and erythema site of injection.					Y				Y	11/27/2001	11/27/2001	0	WBC 25	PVT	OTH	Plaquenil, Fos Anax, Buspar, Paxil	NONE	H/O of Behcet dz, ostopenia, mild COPD			1						1	Cellulitis; Hypersensitivity; Pyrexia	FLU3~SANOFI PASTEUR~U0728AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1044L~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0178917	12/12/2001	VA	22.0	22		M	12/05/2001	Left arm muscle myalgia onset date of immunization continues deep arm muscle soreness and point tenderness at injection site.				Y					U	11/13/2001	11/13/2001	0		UNK	UNK	NONE	NONE	NONE			1						1	Myalgia; Pain	FLU3~PFIZER\WYETH~4018033~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0178918	12/12/2001	VA	46.0	46		F	12/05/2001	Persistent pain over injection site with range of motion									N	11/07/2001	11/07/2001	0	NONE	OTH	PUB	NONE	NONE	Penicillin allergy			1						1	Injection site pain	FLU3~PFIZER\WYETH~4018033~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0178919	12/12/2001	CA	48.0	48		F	11/28/2001	11/28@ 1:35came in for swollen painful L arm after flu shot. Used ice packs and advil. 12/3/01 pt called doing fine now, better no redness									Y	11/17/2001	11/28/2001	11	NONE	OTH	OTH		NONE	allergies, asthma, migraines			1						1	Injection site pain; Injection site swelling	FLU3~PFIZER\WYETH~4018049~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0178920	12/12/2001	CA	46.0	2	.6	M	12/04/2001	Dizziness starting 30 minutes with flu vaccine until on 2 hours later. Patient returned to Clinic and rested under observation.				Y					Y	12/03/2001	12/03/2001	0		OTH	PVT	Tripecol, Beconase	NONE	Grand mal seizure, Dec 1993. Brain surgery Dec 1993			1						1	Dizziness	FLU3~EVANS VACCINES~E06241KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0178921	12/12/2001	KS	61.0	54		F	12/04/2001	Left arm became sore on day of injection in the evening day 2 arm became warm to touch, red with some welts from shoulder to elbow. Instructed to ice area and take Benadryl 25mg every 6 hrs and report to Dr, Friday. Friday called redness was gone welts were gone had some soreness left. will continue benadryl over weekend and call Monday. All symptoms resolved by Monday.									Y	11/27/2001	11/27/2001	0	NONE	PVT	OTH			s/p lung cancer hyperlipidema			1						1	Injection site erythema; Injection site pain; Injection site warmth; Urticaria	FLU3~EVANS VACCINES~E00971HA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1051L~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0178922	12/12/2001	KY	83.0	84		F	12/03/2001	Hives developed about 18 hours after injection and treated with Benadryl.				Y					Y	11/26/2001	11/27/2001	1		PVT	PVT		NONE	Sulfa allergy, osteoarthritis, atrial fib, hypercholesterolemia, stasis dermatitis			1						1	Urticaria	FLU3~SANOFI PASTEUR~UO707AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178923	12/12/2001	IA	51.0	51		F	12/05/2001	Received flu vaccine 12/03/2001. Woke 12/04/2001 with numbness left side of chest, by noon this has spread into left shoulder, arm, neck and face.									N	12/03/2001	12/04/2001	1	NONE	OTH	PVT	Zocor, Prilosec and Celexa	NONE	Allergic-PCN, Actifed, MVP, hyperlipidemia, restless leg syndrome and GERD			1						1	Hypoaesthesia	FLU3~SANOFI PASTEUR~UO701AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178924	12/12/2001	IL	58.0	58		F	12/06/2001	Left deltoid (site of injection0 red, inflamed, tender to touch. treated with erythromycin 333 TID for 5 days.				Y					U	12/03/2001	12/03/2001	0	NONE	PVT	PVT	Toprol XL, Estrates, Levsin Aciphex	NONE				1						1	Injection site hypersensitivity; Injection site inflammation; Vasodilation procedure	FLU3~SANOFI PASTEUR~UO708AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178925	12/12/2001	AK	26.0	26		M	11/17/2001	The pt states that he had body aches about 1 month ago and was getting better, then he got the flu shot and it all came back with body aches and fatigue. He has not seen an MD.									U	11/13/2001	11/14/2001	1		PUB	PUB	NONE	Body aches				1						1	Fatigue; Pain	FLU3~SANOFI PASTEUR~U0680AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178926	12/12/2001	TN	1.0	1	.0	F	12/04/2001	Post vax, the pt developed fever and a diffuse, discreet, papular rash on abdomen and trunk. Fever to 104F.				Y					Y	11/27/2001	11/28/2001	1		PVT	PVT		NONE	NONE			1						1	Pyrexia; Rash papular	FLU3~SANOFI PASTEUR~U0700AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0426L~UNK~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0178927	12/12/2001	OH	65.0	65		F	12/04/2001	Post vax, the pt developed chest pain, leg pain, dizziness, nausea and vomiting and a loss of appetite. Her temperature was 101F.				Y					Y	11/30/2001	11/30/2001	0	Temperature-101F	PVT	PVT	Synthroid 0.125mg qd	NONE	Hypothyroidism			1						1	Anorexia; Chest pain; Dizziness; Nausea; Pain; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~4018030~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1070K~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0178928	12/12/2001	MO	38.0	38		F	11/30/2001	Within 8 hours, post vax, the pt developed an abdominal rash, smooth skin but red spots, small and scattered.									U	11/27/2001	11/27/2001	0		OTH	OTH						1						1	Rash	FLU3~SANOFI PASTEUR~U0727AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178929	12/12/2001	MO	33.0	33		F	11/30/2001	Local reaction in 24 hours: redness, swelling, hot, itchy.									Y	11/27/2001	11/28/2001	1		OTH	OTH		NONE	Sulfa			1						1	Injection site reaction; Oedema; Pruritus; Vasodilation procedure	FLU3~SANOFI PASTEUR~UO727AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178613	12/13/2001	MO	62.0	62		M	12/05/2001	It was reported that a 62 year old male pt received a Fluzone SV '01-'02 vaccination on 11/16/01 at 12:50. Reportedly, within 5 minutes of receipt of Fluzone administration, the pt developed hives, tachycardia and shortness of breath. The pt thought he was going to pass out. He was sent to the ER and hospitalized for 4 days for atrial fibrillation. The pt recovered from this experience. From follow up correspondence received on 12/26/01, it was reported that the patient has returned to normal activity. The report has been received, no additional information at this time.				Y	Y	4			Y	11/16/2001	11/16/2001	0	EEG-abn	PVT	PVT	Synthroid; Centrum Silver	NONE	Allergy to Penicillin, sulfa and corn-based substance		U2001012310	1						2	Atrial fibrillation; Dizziness; Dyspnoea; Electrocardiogram abnormal; Tachycardia; Urticaria; Atrial fibrillation; Dyspnoea; Electroencephalogram abnormal; Tachycardia; Urticaria	FLU3~SANOFI PASTEUR~DO681AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~00681AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0178960	12/13/2001	MO	3.0	3		M	11/28/2001	The pt had no problems immediately after injection or prior to being discovered dead in crib at 05:45 on 11/28/01. On the last check of pt at 03:00 on 11/28/01, he was laughing and playing. Death certificate indicates the child died from shaken baby syndrome (suffering from this since 5 weeks old according to the dept of health).	Y	11/28/2001							N	11/28/2001	11/28/2001	0	NONE	PUB	PUB	Phenobarbital; Baclofen; Robinul; Extendryl; Zyrtec Syrup; Nasonex Spray; Senocot Children's Syrup; NaFl; Acetaminophen Solution; Atrovent Neb	NONE	Shaken baby syndrome at 5 weeks of age; Blind; CA; Seizures; 13 weeks premature; Disorder microcephaly; NPO with G-tubes		MO2001063	1						1	Child maltreatment syndrome	FLU3~PFIZER\WYETH~4018041~5~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0178964	12/13/2001	CO	1.8	1	.8	M	01/02/2002	It was reported that a 22 month old male pt received a Fluzone SV '01-'02 vaccination. Reportedly, 10-12 hours, post vax, the pt became very stiff, unresponsive and turned blue for approx. 15 minutes. The child did not recognize his parents during this time. There was no report of fever. Further information is requested. From follow-up correspondence received on 1/2/02 it was reported: MD diagnosed this as night tremors, did not feel it was a seizure. Very difficult to put mom's history together. Child checked out fine. Has had no further episodes. At this point MD did not feel it was a reaction to vaccine. Reportedly the pt recovered from this experience. The vaccination date 12/05/01 at 3:30pm was also provided.									Y	12/05/2001	12/06/2001	1	NONE	PVT	OTH		NONE	NONE		U2001012360	1						1	Coma; Cyanosis; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U0601AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178965	12/13/2001	NC	66.0	66		M	12/12/2001	Post vax, the pt developed progressive muscle and joint pain, fever, and partial paralysis in muscles (severe leg and shoulder pain). I believe this is Guillain-Barre Syndrome. No tests have been done yet. They act like GBS doesn't exist. The doctors are no help.			Y	Y	Y	10		Y	N	11/13/2001	11/13/2001	0	NONE	MIL	MIL	Potassium Chloride; ranitidine HCL; Warfarin; Allopurinol; Vitamin E; Furosemide; Ecotrin; Garlic soft gel		Congestive heart failure; Angina			1						1	Arthralgia; Guillain-Barre syndrome; Myalgia; Pain; Paralysis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~7+~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0178967	12/13/2001	ME	53.0	53		M	11/30/2001	The pt received the vaccines in his left deltoid. The site bled slightly. The pt's wife called the next day with a pt complaint of fever, achiness and fatigue. Denied swelling or redness at the site. Later that evening, it became warm to touch. The pt was hospitalized but is recovering. According to the pt's doctor, the pt was found to have underlying strept infection. Cultures performed on vaccinee came back negative in 72 hours. Pt was released from the hospital and is doing fine.					Y	2			U	11/27/2001	11/28/2001	1	Blood culture-awaiting	PVT	OTH	Albuterol Inhaler; ranitidine	NONE			ME0143	1						1	Bacterial infection; Fatigue; Injection site warmth; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U0683EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0923L~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0178968	12/13/2001	OK	55.0	55		F	12/04/2001	Client felt lightheaded and palpitations approximately 10-15 min post injection. States palpitations occurred two more times. She notified her doctor and I gave her Benadryl 50 mg by mouth.									Y	12/04/2001	12/04/2001	0		OTH	OTH	Effexor, Premarin, Timoptic		Allergic to sulfa drugs	X~Influenza (Seasonal) (Fluzone)~~30.00~In Patient		1						1	Dizziness; Palpitations	FLU3~SANOFI PASTEUR~U0699AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178969	12/13/2001	VA	41.0	41		F	12/07/2001	Felt tingling of upper lip then lip began to swell. Saw personal physician who ordered Benadryl 50 mg.				Y					Y	12/04/2001	12/05/2001	1		OTH	PVT	Humalog 75/25; Estrace	NONE	Sulfur Allergic; Diabetic			1						1	Oedema; Paraesthesia	FLU3~PFIZER\WYETH~4018052~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0178970	12/13/2001	UT	53.0	53		F	11/16/2001	Nausea, abdominal pain, headache.									Y	10/25/2001	10/29/2001	4		UNK	UNK						1						1	Abdominal pain; Headache; Nausea	FLU3~SANOFI PASTEUR~U0601AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178971	12/13/2001	NJ	65.0	65		F	12/11/2001	Palms of hands started itching 5 minutes, weakness, hot and cold, felt faint, throat closed up, blood pressure dropped.				Y					Y	12/08/2001	12/09/2001	1		UNK	UNK						1						1	Chills; Dizziness; Laryngospasm; Pruritus	FLU3~SANOFI PASTEUR~U0698AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178972	12/13/2001	TX	25.0	24		M	11/15/2001	Redness of skin; feeling of swelling and pain.									Y	10/22/2001	10/23/2001	1	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Oedema; Pain; Vasodilatation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178973	12/13/2001	TX	49.0	49		F	11/15/2001	Itching and pain at site of injection.									Y	10/22/2001	10/22/2001	0		UNK	PVT						1						1	Injection site pain; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178974	12/13/2001	TX	38.0	38		F	11/01/2001	Red and irritated size of a quarter, Like a mosquito bite.									Y	10/22/2001	10/23/2001	1		OTH	PVT						1						1	Agitation; Vasodilation procedure	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178976	12/13/2001	TX	21.0	21		F	11/01/2001	Red and irritated. Bump about the size of a quarter.									N	10/22/2001	10/23/2001	1		OTH	PVT			Penicillin			1						1	Agitation; Vasodilation procedure	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178977	12/13/2001	TX	32.0	32		F	11/05/2001	Ecchymosis approximately 1 cm 24 degree, No therapy.									Y	10/22/2001	10/23/2001	1		OTH	PVT			CIPRO			1						1	Ecchymosis	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178978	12/13/2001	TX	33.0	33		F	11/15/2001	Red, itching, heat.									Y	10/22/2001	10/22/2001	0		OTH	PVT						1						1	Hypersensitivity; Pruritus; Vasodilation procedure	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178979	12/13/2001	TX	53.0	53		F	11/15/2001	Red, itching, heat.									Y	10/22/2001	10/23/2001	1		OTH	PVT						1						1	Hypersensitivity; Pruritus; Vasodilation procedure	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178980	12/13/2001	TX	29.0	29		F	10/31/2001	Red circle, itching, hot around area where shots was injected.									Y	10/22/2001	10/23/2001	1		OTH	PVT						1						1	Hypersensitivity; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178981	12/13/2001	TX	22.0	22		M	11/01/2001	Itching, warm, comp. Red large ecchymotic area, pain.									Y	10/22/2001	10/23/2001	1		OTH	UNK						1						1	Ecchymosis; Hypersensitivity; Pain; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178982	12/13/2001	TX	29.0	29		F	10/31/2001	Red/large welt, about the size of a baseball, was hot to touch with itching/discomfort.									Y	10/22/2001	10/22/2001	0		OTH	PVT						1						1	Hypersensitivity; Pain; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178983	12/13/2001	TX	51.0	51		F	10/31/2001	Red rash, Hehing, hurting (arm when I use it), lump.									Y	10/22/2001	10/22/2001	0		UNK	UNK	Allegra D		Sinus			1						1	Injection site mass; Pain; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178984	12/13/2001	TX	49.0	49		F	10/31/2001	Dime size bright pink area at injection site time 2 days.									Y	10/22/2001	10/23/2001	1		UNK	UNK						1						1	Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178985	12/13/2001	TX	63.0			F	10/31/2001	Red, hot, small PUNP and itching.														UNK	UNK						1						1	Pruritus; Vasodilation procedure	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178986	12/13/2001	TX	23.0			F	10/31/2001	Swollen redish knot with itchiness and soreness.									Y					UNK	UNK						1						1	Injection site mass; Oedema; Pain; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178987	12/13/2001	TX	22.0	22		F	10/31/2001	Right arm (near tricep) swelling, a big lump and redness occurred with itching.									Y	10/22/2001				OTH	OTH						1						1	Injection site mass; Oedema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0178988	12/13/2001	NY	63.0	63		M	12/03/2001	About 4-5 hours after vaccine given broke out in hives-upper inner thighs, through the night hives progressively, worsened. Went to ER 7 PM. Given Benadryl IM and predinsone PO. Prescription for Medrol pack. Discharged to home. Initially hives improved. Around noon hives increased. Called PMD , told to take more Medrol. By next AM hives gone. Started to reappear. Called PMD, went to see him and given prescription antihistamine. After several hours improved. By next day completely gone and have not recurred.				Y					Y	11/27/2001	11/27/2001	0	NONE	UNK	UNK	BP medication	NONE	Hypertension. No known allergies-poss bee sting.			1						1	Urticaria	FLU3~SANOFI PASTEUR~UO703AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178989	12/13/2001	FL	43.0	43		F	12/07/2001	Immediate edema and erythema approximately 2 inches in diameter. Pain and erythema at injection site 12/07/2001. No treatment.									Y	12/05/2001	12/05/2001	0	NONE	PUB	PUB	Aciphex 20mg	NONE	History of Multiple Allergies			1						1	Injection site erythema; Oedema; Pain	FLU3~SANOFI PASTEUR~UO690AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178990	12/13/2001	OK	50.0	50		M	12/04/2001	Vaccination given in left deltoid 11/23/2001 with immediate swelling approximately 1 inch at 10 minutes. Swelling approx size of quarter. Returned to health unit 12/03/3001 with 2 inch bruise.									Y	11/23/2001	11/23/2001	0		PUB	UNK	NONE	Leukemia				1						1	Contusion; Oedema	FLU3~SANOFI PASTEUR~UO699AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178991	12/13/2001	CA	36.0	36		F	12/05/2001	Left arm became acutely red and swollen from site and down to the fingers. Associated with malaise and fever up to 104. Pt took ibuprofen and symptoms decreased 50% by 24 hours and resolved by 72 hours.									Y	11/29/2001	11/30/2001	1		PVT	PVT	NONE	NONE	Recurrent pneumonia			1						1	Malaise; Oedema; Vasodilation procedure	FLU3~SANOFI PASTEUR~UO711AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1043L~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0178992	12/13/2001	ME	43.0	43		F	12/04/2001	Immediately after the injection, pt complained of pain down entire length of left arm. When checked one hour later pain had subsided after being iced but pt still reported painful.									Y	12/04/2001	12/04/2001	0		OTH	PUB	UNK	NONE	NONE		ME01042	1						1	Pain	FLU3~PFIZER\WYETH~4018024~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0178993	12/13/2001	MA	44.0	44		F	11/18/2001	Approximately 16 minutes after flu injection client complained of itchiness all over body and upper body including face was very flushed. Epinephrine 1:1000 0.35cc injected into flu injection site approximately 18 minutes after original flu shot. 911 called at the same time, 4-5 minutes after 1st epinephrine injection. Complained of numb, tingling feeling about face, neck and hands. Second Epi 1:1000 0.15cc injected into the same area. BP 158/84 P 60 Transported to Emergency Room via ambulance approximately 25 minutes after flu vaccine given.				Y					Y	11/06/2001	11/06/2001	0		PVT	PVT	NONE	NONE	Latex Sensitive			1						1	Flushing; Paraesthesia; Pruritus	FLU3~SANOFI PASTEUR~UO682AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178994	12/13/2001	ME	41.0	41		F	12/04/2001	Immediately after receiving vaccine the pt complained about a burning sensation down the entire length of her left arm. Checked with pt 2-3 hrs later and burning had ceased.									Y	12/04/2001	12/04/2001	0		OTH	PUB	UNK	NONE	Non-specific allergies		ME0144	1						1	Pain	FLU3~PFIZER\WYETH~4018024~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0178995	12/13/2001	ME	51.0	51		F		Day after immunization, the school nurse where the pt is an employee caller to report had rash from breast to anale with raised quarter size red spots to joint pain by lateral more intense on right than left. Took Benadryl and ibuprofen.									Y	11/28/2001	11/29/2001	1		PUB	PUB	Prempro	NONE	NONE			1						1	Arthralgia; Rash	FLU3~SANOFI PASTEUR~UO683EA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178996	12/13/2001	PA	51.0	51		F	11/28/2001	Shot given 11/26/2001. Cellulitis developed 11/28/2001.				Y					U	11/26/2001	11/28/2001	2		PVT	PUB	NONE	NONE	Obesity, ETOH abuse, CUI, CLBP		PA0161	1						1	Cellulitis	FLU3~SANOFI PASTEUR~UO697AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179030	12/14/2001	PA		52		F	12/11/2001	Client does have an allergy to antibiotics so she took some Benadryl prior to getting the flu shot and denied a reaction to it before. Post vax, she became flushed but had no signs of swelling or shortness of breath. I called the pt back at 12:00 on this date and she stated her tongue swelled and that she took some more Benadryl after I left. At 13:45 on 10/31/01, telephone call to MD's office made aware of above. On 11/6/01, the pt had chills and was thought she might have URI, so a sterile catheter was done for UA.			Y						Y	10/31/2001	10/31/2001	0		OTH	PVT						1						1	Chills; Flushing; Tongue oedema; Urinary tract infection	FLU3~SANOFI PASTEUR~U0682AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0179031	12/14/2001					F	12/12/2001	Hospital employee given influenza vaccine, then went home. Injection site became red, hot, raised (about 3 by 4 inches). Reported to infection control nurse on 12/12/2001. Still red and hot.										12/10/2001	12/10/2001	0		UNK	UNK						1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~PFIZER\WYETH~4018042~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0179032	12/14/2001	CO	79.0	79		F	12/07/2001	Pt received pneumonia vaccine in right deltoid and flu vaccine in left deltoid on 11/06/2001. On 11/07/2001, pt experienced red, swollen arm. On 11/08/2001 pt went to MD and was given 5 pills.				Y						11/06/2001	11/07/2001	1		UNK	UNK						1						1	Oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1456K~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0179033	12/14/2001		20.0			F		Young African American female given flu shot and within 2 hours developed mild left posterior swelling of tongue and inflammation to left bicep. Shot administered at 1300 and reaction noted by 1500 on 12/01/2001.										12/01/2001	12/01/2001	0		UNK	UNK						1						1	Injection site inflammation; Oedema	FLU3~SANOFI PASTEUR~UO686AB~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179037	12/14/2001	MI	41.0	41		F	12/10/2001	Initial pain post-injection followed by vigorous, throbbing pain from lateral aspect of upper humerus to anterior mid-humerus and continuing to posterior aspect of forearm and hand. Visited family physician 1 week post-injection. Am now receiving physical therapy. Arm pain and limited movement left arm.				Y					N	11/06/2001	11/08/2001	2	Left shoulder X-ray negative.	OTH	UNK		NONE	NONE			1						1	Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~0685AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179038	12/14/2001	RI	68.0	68		M	12/07/2001	Typical flu symptoms, shaking, hot, temp 100.9. Treatment in hospital.				Y					Y	12/02/2001	12/02/2001	0	Blood test and X-ray	OTH	OTH		NONE	NONE			1						1	Hot flush; Influenza; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0179039	12/14/2001	IN	56.0	56		F		Chest pain and shortness of breath									U	10/19/2001	10/20/2001	1		PUB	UNK						1						1	Chest pain; Dyspnoea	FLU3~SANOFI PASTEUR~UO5968A~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179040	12/14/2001	ME	31.0	31		F	12/05/2001	Pt presents 2 days following flu vaccine with 1.5 inch diameter red firm region of deltoid left arm. No discomfort. Taking ibuprofen PRN. Instructed on use of heat.									U	12/03/2001	12/04/2001	1	NONE	PUB	OTH	NONE	NONE	NONE			1						1	Injection site hypersensitivity; Vasodilation procedure	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0179041	12/14/2001	KS	35.0	35		M		Fifteen to 20 minutes after flu shot upper left arm got numb burning sensation and numbness went down to outer two fingers. Left eye and sinuses felt dried out with pressure. Left side of neck and upper back felt tight and painful. Left hip down to ankle had pain.									Y	12/01/2001	12/01/2001	0		MIL	MIL	Claritin D			~Typhoid Vi Polysaccharide (Typhim Vi)~7~35.00~In Patient		1						1	Pain; Paraesthesia; Sensation of pressure	FLU3~SANOFI PASTEUR~UO702AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179042	12/14/2001	WI	75.0	75		M	11/30/2001	Urticaria upper arms, legs, back and abdomen 2 hours after immunization. Pruritic rash. Treated with Sarna lotion 190 hydrocortisone topical and atarax 25 mg 1/2 tablet PO q 6 hours PRN.				Y					U	11/27/2001	11/27/2001	0	NONE	PVT	OTH	Simvastin and metaformin	NONE	Diabetes mellitus and hypercholesteremia			1						1	Rash pruritic; Urticaria	FLU3~SANOFI PASTEUR~U0671DA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179043	12/14/2001	VA	38.0	38		F	12/04/2001	Five reddened, raised wheals approximately 4 cm in circumference on left deltoid that remained unchanged for 3.5 days. By the 4th day, no raised areas, but skin still reddened.									Y	11/28/2001	11/30/2001	2		PUB	PUB					VA01037	1						1	Urticaria; Vasodilation procedure	FLU3~PFIZER\WYETH~4018026~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0179045	12/14/2001	VA	44.0	44		F	12/07/2001	Inflammation and tenderness										12/05/2001	12/06/2001	1		MIL	MIL		NONE				1						1	Injection site inflammation; Tenderness	FLU3~SANOFI PASTEUR~UO704AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179046	12/14/2001	PA		74		F	12/11/2001	Chills, temp 105, swollen arm, left arm. Pain in arm, shoulder to elbow. Hot and red 0.5 inch from elbow to upper arm. Biojector used (within boundaries of reactions of adverse response to Pneumovax 23 ?).				Y					Y	10/22/2001	10/24/2001	2	Sed rate and CBC	OTH	PVT						1						1	Chills; Oedema; Pain; Pyrexia	FLU3~SANOFI PASTEUR~UO682AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1448K~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0179047	12/14/2001	CA	43.0	43		F	11/19/2001	Pt states reaction 24 hours later. Left arm red/purple bruised at injection site. No treatment. Pt came to clinic on 11/19/2001. Reaction increased down arm.									N	11/13/2001	11/14/2001	1	Pt sent direct OVMC MWI	PUB	PUB	MVI tasix, Aldaltone, Folate, Inderal, Buspar, Klongpin	Cirrhosis ETOH	NKDA, ETOH Cirrohsis		CA01035	1						1	Contusion; Injection site hypersensitivity	FLU3~SANOFI PASTEUR~UO684AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179048	12/14/2001	CA	31.0	31		F	11/30/2001	Itchy, redness at site. One diameter, headache, wheezing, elevated respiration, flu-like symptoms and swollen glands.									U	11/29/2001	11/29/2001	0	NONE	PUB	PUB	Albuterol, 2 puffs PRN and Serevent, 2 puffs PRN		Asthma		CA010132	1						1	Headache; Influenza like illness; Lymphadenopathy; Pruritus; Respiratory rate increased; Vasodilation procedure; Wheezing	FLU3~SANOFI PASTEUR~UO685AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179052	12/14/2001	NY	55.0	54		M	12/13/2001	Pt began feeling numbness in fingers, hands and feet. Also a slight irritation of the skin, all symptoms began on Sunday 12/09/2001. Pt saw MD and neurologist 12/11/2001. He phoned today 12/13/2001 to report symptoms and states he feels a slight improvement today from 12/09/2001.				Y					U	11/27/2001	12/09/2001	12	ESR, ANA, Lymetiter, FTA, SPEP, Amnio factor, AAC, FBG, Electrophoresis, Anti-Mag	OTH	PVT	NONE	NONE	NONE			1						1	Paraesthesia; Skin irritation	FLU3~SANOFI PASTEUR~UO703AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179055	12/14/2001	GA	67.0	67		F	12/05/2001	Right upper arm red, warm to touch, painful, edematous approximately 1 day after vaccine administration. Client states taking Advil, advised warm moist heat. Client states redness and pain subsiding.									Y	12/03/2001	12/03/2001	0	NONE	PUB	UNK		NONE	Codeine			1						1	Oedema; Pain; Vasodilation procedure	FLU3~PFIZER\WYETH~4018054~7+~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0946K~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0179066	12/14/2001	CA	75.0	75		F	11/13/2001	Pt complained of a sore arm. She couldn't lift arm on 11/2/01. On 11/10/01, she had a sore throat with phlegm. She denied fever. On 11/11/01, she went to the doctor and was treated with amoxicillin. She feels better.				Y					U	11/02/2001	11/02/2001	0		OTH	PUB	NONE	NONE	NONE		CA010134	1						1	Hypokinesia; Injection site pain; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U0682AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0178909	12/17/2001					M	12/12/2001	Pt diagnosed with Guillain-Barre syndrome, presumably secondary to influenza vaccine. Pt presented with respiratory distress and has no other respiratory infections or obvious inciting cause for Guillain-Barre.			Y		Y						11/25/2001			UNK	UNK	Flovent; Asacol; Tiazac; Coumadin; amiodarone		Irritable bowel syndrome; non-hodgkins lymphoma 2 years ago; organic heart disease (admitted a couple of weeks ago for atrial fibrillation).			1						2	Arthralgia; Constipation; Gait disturbance; Guillain-Barre syndrome; Laboratory test abnormal; Muscular weakness; Paraesthesia; Pneumonia; Respiratory disorder; Guillain-Barre syndrome; Respiratory distress	FLU3~EVANS VACCINES~E04851KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation	Influenza
0179077	12/17/2001	VA	60.0	60		F	11/21/2001	Fever, headache, neck stiffness. Pt hospitalized 11/20/2001.					Y				Y	11/08/2001	11/13/2001	5	CSF culture, blood culture, CBC, all results pending.	PVT	PVT	Tamiflu, Analgesics	NONE	sulfur allergy, COPD, diverticulitis		VA01038	1						1	Headache; Musculoskeletal stiffness; Pyrexia	FLU3~PFIZER\WYETH~4018033~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0179079	12/17/2001	MI	59.0	59		F	12/03/2001	Pt states 1st day hot hot, hard & itchy and 2nd day hives under L axilla and spread to breast & legs. 3rd day arm very swollen, could not bend, hot to touch and very red. Went to ER 12/1/01. Given Benadryl, Solumedrol, Prednisone packet and cortisone cream. Instructed pt to call her family Dr to make him aware, and not to get flu vaccine in the future. Pt stated she has had flu vaccine for 10 yrs except for last year when there was a shortage.				Y					Y	11/28/2001	11/28/2001	0		PUB	PUB			Asthma			1						1	Injection site erythema; Injection site mass; Injection site swelling; Injection site warmth; Urticaria; Erythema; Feeling hot; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4018043~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4018043~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0179080	12/17/2001	MI	31.0	31		F	12/04/2001	Within 15 minutes complained of numbness entire length of arm. Within 30 minutes, hot and flushed, SOB upon lying down, started to vomit twice. Within 2 hrs, diarrhea onset lasting 48 hours. Taken home. Vomited 3 times. Unable to function. At 40 hrs from onset had severe headache lasting 8 hours.									Y	11/24/2001	11/24/2001	0		UNK	OTH		NONE	Psoriasis			1						1	Diarrhoea; Dyspnoea; Headache; Hot flush; Paraesthesia; Vomiting	FLU3~PFIZER\WYETH~4016038~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0179081	12/17/2001	VA		64		F	12/07/2001	Local redness, swelling noted ? some difficulty moving arm. Took tylenol felt better. By 2/6/01 arm @ point of injection very swollen. Saw Dr who placed her on Keflex for 5 days. (6 inch swollen).				Y					Y	12/04/2001	12/04/2001	0	NKDA	PUB	PUB	Synthroid, estradiol patch	NONE	Allergic Phenobarbital, phenergan, decadron, Novocain			1						1	Injection site erythema; Injection site swelling	FLU3~PFIZER\WYETH~4018026~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1160L~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0179082	12/17/2001	MA	58.0	58		F	12/07/2001	Rec'd flu vaccine 12/5/01 4:30pm. Developed fever, chills, headache. 11am 12/6 Tx with tylenol - Sx free as of 9pm 12/6/01.									Y	12/05/2001	12/06/2001	1	NONE	PVT	OTH		NONE	NONE	~Influenza (Seasonal) (no brand name)~~0.00~In Sibling	MA0105	1						1	Headache; Pyrexia	FLU3~SANOFI PASTEUR~U0676AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179083	12/17/2001	NY	82.0	82		F	12/06/2001	Intensive itching at injection site, no rash or fever. Pt went for medical follow up. Prescribed benadryl for itching. (red around site)									Y	11/30/2001	12/01/2001	1	NONE	PUB	PVT	NONE	NO	NO			1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~A018033~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0179084	12/17/2001	ID				F	12/14/2001	Pt with increased pain, redness and fever following injection, and developed cellulitis L deltoid.				Y					U	11/20/2001	11/30/2001	10		MIL	OTH		NONE	ASA, Sulfa, PMH: asthma			1						1	Cellulitis; Injection site erythema; Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~UB071AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1159L~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0179085	12/17/2001	NY	46.0	46		F	11/19/2001	10 minutes after receiving vaccine in L deltoid arm, pt felt warm in chest and L arm itching itching of L arm then became ?. Developing a few hives on neck. Benadryl PO given with resolution of most symptoms.									Y	11/19/2001	11/19/2001	0		PUB	PVT		NONE	allergist diagnosed latex allergy			1						1	Feeling hot; Injection site hypersensitivity; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0683AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179086	12/17/2001	NC	20.0	20		F	12/07/2001	Loss of appetite no energy, breaking out in cold chills, nausea, headache - hurts when I walk and open my eyes. Took some tylenol, it suppressed the headache but it feels like it might coming back.									Y	12/06/2001	12/06/2001	0		MIL	MIL	IPPD/Conn/C0866AB/LFA-2/9/24/01		Allergic to Penicillin			1						1	Anorexia; Asthenia; Chills; Headache; Nausea	FLU3~SANOFI PASTEUR~U0702AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179087	12/17/2001	MI	71.0	71		M	12/10/2001	The pt states he felt immediate pain at the injection site and continued to have pain and then had difficulty with mobility of left shoulder. He presented to MD on 12/6/01 to evaluate. Pt dx'd with a frozen shoulder. No redness or swelling at the site. Pt sent to physical therapy.				Y					Y	11/14/2001	11/14/2001	0	NONE	PVT	PVT	Imdur; Prinivil; Prinizide; metoprolol; Zocor; glipizide; ASA		DM; CAD			1						1	Arthropathy; Hypokinesia; Injection site pain	FLU3~SANOFI PASTEUR~U0594AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179088	12/17/2001	MO	35.0	35		M	12/08/2001	2 days, post vax, the pt developed acute onset of high fevers 102F-103F, headache, mild cough, arthralgias, myalgias, near syncope, diaphoresis and tinnitus.				Y					U	12/03/2001	12/05/2001	2	Strept Screen; A, Throat-neg	OTH	OTH	NONE	NONE	NONE			1						1	Arthralgia; Cough; Headache; Hyperhidrosis; Myalgia; Pyrexia; Syncope; Tinnitus	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0179089	12/17/2001	CO	10.0	9		M	12/11/2001	While visiting with mother about another sibling, the mother mentioned that the pt had became dizzy, weak and pale, 2 hours after receiving the flu vaccine on 11/30/01. No apparent emergency care was needed. Told mother that she should mention this to the doctor the next time she was in the office.									Y	11/30/2001	11/30/2001	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Asthenia; Dizziness; Pallor	FLU3~SANOFI PASTEUR~U0711AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179090	12/17/2001	LA	10.0	10		M		The pt developed hives, 5 days, post vax. He was treated with Prednisone, Claritin and Benadryl.				Y					Y	11/14/2001	11/18/2001	4		PVT	PVT		NONE	NONE			1						1	Urticaria	FLU3~PFIZER\WYETH~4018040~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~SMITHKLINE BEECHAM~5209B9~1~IM~~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0179091	12/17/2001	ID	70.0	70		F	11/21/2001	On day 1, post vax, the pts arm was sore. On day 2, she had a stiff neck X 1 day. On day 5, she had swelling of the face with hives on face and neck X 1 day. Also on day 5, she had itching of her face X 2 days. Then on day 5, she had night sweats X 1 day.									N	11/15/2001	11/17/2001	2	NONE	OTH	PVT	Lasix; Lotensin; Premarin; Micro-K	Chronic UTI	HTN, Chronic UTI	~Influenza (Seasonal) (no brand name)~~70.00~In Sibling	ID01072	1						1	Injection site pain; Musculoskeletal stiffness; Night sweats; Pruritus; Swelling face; Urticaria	FLU3~SANOFI PASTEUR~U0706AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179130	12/18/2001	NY	40.0	40		M	12/13/2001	No symptoms of adverse reaction noted following administration of vaccine. Autopsy performed and cause of death was listed as Cardiorespiratory failure as a consequence of seizure.	Y	12/01/2001							N	11/30/2001	12/01/2001	1	Autopsy performed	PVT	PVT	Inderal; Metamucil; Ativan; Vitamin E; Cogentin; Risperdal	NONE	Development disability; severe MR; mild to moderate scoliosis; intermittent explosive disorder; PICA; history of pin worms; allergy to Navane and Nitrous Oxide			1						1	Cardio-respiratory arrest; Convulsion	FLU3~EVANS VACCINES~E04831KA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0179131	12/18/2001	NY	77.0	77		F	12/13/2001	No symptoms of adverse reaction noted following administration of vaccine. Cause of death pneumonia.	Y	12/07/2001							N	11/16/2001	12/07/2001	21		PVT	PVT		NONE	Development disability, Down's Syndrome			1						1	Pneumonia	FLU3~EVANS VACCINES~E04831KA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0179132	12/18/2001	ID	43.0	43		F	12/13/2001	A 43 year old female reported that she received a dose of Flu Shield '01-'02 vaccine on 12/10/01. Within 3 minutes, she experienced tingling and numbness in her arm which progressed to her face and left side, difficulty breathing, itching and vision was out of focus. At the date of the report, no further information was available. Tingling, numbness and difficulty breathing are considered Medically Important Events. Follow-up information received from the vaccine administrator on 01/02/2002, stated that the paitent began to feel numb and tingly in the vaccinated arm as she was leaving the room where she was vaccinated. Then while en route home, she experienced the other symtoms as stated above and went directly to a physician for evaluation. The physician allegedly told the patient that he didn't know for sure what caused her symptoms. The patient reported to the vaccine administrator that it took four days for her symptoms to dissipate and for her to feel normal again.									Y	12/10/2001	12/10/2001	0	UNK	PUB	OTH	UNK	UNK	Cow's milk intolerance, Drug hypersensitivity		HQ9434212DEC2001	1						1	Dyspnoea; Paraesthesia; Pruritus; Vision blurred	FLU3~PFIZER\WYETH~4018029~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0179133	12/18/2001	NY				U	12/14/2001	A pharmacist reported that an unidentified pt received an influenza virus vaccine, trivalent, types a and b. Within 2 days of receiving the vaccine, the pt experienced a seizure and was hospitalized. No additional information was available as of the date of this report				Y	Y				U				UNK	OTH	OTH	UNK	UNK	UNK		HQ9405612DEC2001	1						1	Convulsion	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0179151	12/18/2001	OH	57.0	57		M	12/17/2001	Guillain Barre syndrome, axonal form. Per doc 214332, 60 day follow-u, patient was discharged to a rehabilitation facility. He reportedly died several days later. I am unsure at the cause of death, though I suspect he may have suffered a massive pulmonary embolism.	Y		Y	Y	Y		Y		N	11/02/2001	11/29/2001	27	NONE	PUB	PVT	metformin; allopurinol		NONE			1						1	Guillain-Barre syndrome; Lung disorder	FLU3~SANOFI PASTEUR~U0675BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0179152	12/18/2001	GA	30.0	31		F	12/14/2001	Pt received both Pneumovax and flu vaccines in left arm. She developed erythema, requiring hospital admission and IV antibiotics. Resolved.					Y	1			Y	12/07/2001	12/09/2001	2	Blood culture negative	PVT	UNK						1						1	Erythema; Cellulitis	FLU3~PFIZER\WYETH~4018037~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~PFIZER\WYETH~4018037~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0179153	12/18/2001	TN	59.0	59		F	12/06/2001	Client received pneumonia vaccine on 12/03/2001 around 11:30 in the morning. Approximately three hours later, she started experiencing chills and a fever. The latter reached 102 and lasted for twenty-four hours. A swollen area of redness was noted about two inches below the injection site. The underside of the left arm was also tender to the touch. This tenderness lasted for two days after the vaccination.				Y					Y	12/03/2001	12/04/2001	1	On 12/06/01, the patient saw Dr., who feels that the Adverse Event was a systemic reaction. He recommended anti-inflammatory treatment, in the form of Tylenol and heat. He also recommended that the patient not receive the pneumonia vaccine in the future.	PUB	PUB		None	PCN, Erythromycin, Recently recovered from pneumonia		GA01112	1						1	Injection site erythema; Injection site pain; Injection site swelling; Pyrexia	FLU3~EVANS VACCINES~E05221KA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1071K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0179154	12/18/2001	GA	65.0	65		F	11/06/2001	The patient experienced a local reaction to the right upper arm. The slight swollen area was red and warm to the touch.				Y					Y	11/02/2001	11/03/2001	1	None	PUB	UNK	None		None		GA01106	1						1	Feeling hot; Injection site erythema; Injection site oedema	FLU3~EVANS VACCINES~E05221KA~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0995L~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0179155	12/18/2001	AL	48.0	48		F	11/05/2001	Complained of numbness around mouth, approximately 2 minutes after flu shot was administered. Exhibited difficulty talking. Pulse 100, BP 152/90. Pt also complained of very dry mouth, Was given Benadryl 50 mg IM and transported to ER by family members.				Y					Y	11/05/2001	11/05/2001	0		PUB	PUB	Synthroid, Detrol, hormone shot every month	NONE	Codeine allergy		GA01104	1						1	Dry mouth; Hypoaesthesia; Speech disorder	FLU3~SANOFI PASTEUR~UO590AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179156	12/18/2001	GA	36.0	36		F	10/13/2001	Flu shot given @ approx. 2:20pm. By approx. 3:00pm. Pt developed headache, flushing, numbness, in lips & stated  my throat feels like it's closing up.Benadryl 50mg IM given & pt transported to at ER. Pt was observed for approx. 2 hrs & released.				Y					Y	10/31/2001	10/31/2001	0	u/a done @ CRMC - ER	OTH	PUB	N/A	NO	Cipro, Amoxicillin  Dx- fibromyalgia, migraine, headaches	flu like sympoms~Influenza (Seasonal) (no brand name)~~0.00~In Patient	GA01102	1						1	Flushing; Headache; Hypoaesthesia; Throat tightness	FLU3~EVANS VACCINES~05221KA~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0179157	12/18/2001	NC	52.0	52		F	12/04/2001	Pt rec'd influenza and pneumococcal vaccines L upper arm 11/7 called 11/8 reporting pain no fever, no local warmth. Seen 11/9 c/o fever, responding to ibuprofen 2 areas erythema L upper arm slightly warm, very tender. CBC and blood culture drawn. Cephalexin 500mg bid x 7 days; resolution of fever 24 hrs resolving pain and redness 5 days.				Y					Y	11/07/2001	11/08/2001	1	CBC w differential -normal, blood culture no growth (11/9/01)	PVT	PVT	Prozac, vioxx, ibuprofen	NONE	NKDA. menopause, lumbar disc disease		NC01106	1						1	Erythema; Feeling hot; Pain; Pyrexia; Tenderness	FLU3~EVANS VACCINES~E01821LA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~09956~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0179158	12/18/2001	NJ	28.0	28		F	12/11/2001	12/07/2001 developed 3 hives on left leg. On 12/08/2001 hives itching developed arm, lower axilla, back and legs. Zyrtec D 120 mg q 12 hours for 4 days. Zyrtec 10 mg TID for 4 months.				Y					N	12/07/2001	12/07/2001	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~UO731AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179159	12/18/2001	AL	55.0	55		F	12/16/2001	Second day soreness and redness at site that got worse traveled into the arm, to the shoulder and up into the neck, all happened over a 3 week period. Still have pain in right side of neck, arm has pain to the touch and when laid on.  Hurts to pick anything up. Pain traveled from injection site into the shoulder, slight swelling in the neck area. Still having pain.				Y					N	11/06/2001	11/07/2001	1		PVT	PVT		NONE	Hypertension, asthma and diabetic.			1						1	Erythema; Pain	FLU3~EVANS VACCINES~E00931HA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0179160	12/18/2001	NE	50.0	50		F		Nausea and vomiting				Y					Y	11/06/2000	11/07/2000	1		OTH	OTH						1						1	Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0179161	12/18/2001	TX	46.0	46		M	12/14/2001	Pt rec'd immunizations 12/10/01, same day (evening) had onset of fever, chills, weakness. Symptoms resolved by next morning.									Y	12/10/2001	12/10/2001	0		OTH	OTH	gabapentin 300mg po tid	NONE	Allergic to  saccharin, bee stings			1						1	Asthenia; Pyrexia	FLU3~SANOFI PASTEUR~40699AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~474941~UNK~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0179162	12/18/2001	WA		48		M	12/11/2001	Pt called in,  reported he was having a reaction to a vaccine he received on 12/4/01 in L arm. Review of record determined it was the pneumonia vaccine. Pt c/o redness, soreness, swelling and streaking. Advised to f/u  w/MD. Saw MD - no recommendation or f/u necessary, Adverse reaction.				Y					Y	12/04/2001	12/05/2001	1	NONE	PUB	OTH		NONE	NONE			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~PFIZER\WYETH~4018037~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0802L~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0179163	12/18/2001	NY	52.0	52		M	11/20/2001	Pt received flu immunization right deltoid IM approximately 5 PM on 11/15/2001. Friday night 11/16/2001, developed itchy red spot right deltoid area. by Saturday AM 11/17/2001 developed itchy all over both arms. By 8:30 PM Saturday 11/17/2001, has itching and red blotches which pt calls hives over entire body. Took honey and oatmeal solution bath, applies ointment an this called itching. Seen 11/18/2001 4:45 PM itching and blotches reappeared. Repeat Bath and ointment helped very little. At 10 PM pt went to ER. He was given Prednisone 20 mgm bid PO for 5 days. He has appointment with PCP on Friday 11/23/2001. Pt reports he continues to have breakthrough itching and blotches between doses of Prednisone. Has occasionally taken Benadryl for itching. Pt works in a lumber yard: is exposed to wood products, insulation, paints, stains, chemicals and concrete building products. Pt also works at building construction.				Y					N	11/15/2001	11/16/2001	1	NONE	PUB	PUB	Thyroid; Bufferin		Multiple Sclerosis		NYS21023	1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~UO600UA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179164	12/18/2001	OH	39.0	39		F	11/30/2001	On 11/29/01 at 11:00, the pt felt shaky, light-headed, fever and body aches. Seen by MD at 14:40. Pt states she also feels heavy in my chest.				Y					U	11/28/2001	11/29/2001	1		PVT	PUB	Advair; Asthmacort; Univasc; resperolol; diazepam; Paxil; Remeron		Resolved sinusitis; asthma; HTN; fibroid tumors; depression; Dyslipidemia		OH0072	1						1	Chest pain; Dizziness; Pain; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U0760AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~470592~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0179165	12/18/2001	MD	29.0	29		F	11/19/2001	The injection site started to itch and she scratched it. The area is warm to the touch, reddened and slightly swollen. She is still recovering.									N	11/12/2001	11/13/2001	1		PUB	OTH		NONE	NONE			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Pruritus	FLU3~EVANS VACCINES~E08341LA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0179166	12/18/2001	AL	63.0	63		F	12/07/2001	Patient experienced a localized reaction  of 6 cm X 5 cm on the left deltoid. The area was erythemic and warm to palpitation. Treatment included observation and ice packs.									Y	11/15/2001	11/16/2001	1	N/A	PVT	PVT	Lipitor, Premarin	None	ASA-antihistamines-codeine-morphine. elevated cholesterol, menopausal			1						1	Feeling hot; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U0693AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179167	12/18/2001	MI	25.0	25		M	11/29/2001	The pt complained of left arm being limp, unable to use without increased pain. He had swelling in his left hand. He came to the clinic and was seen on 11/28/01. Ordered Benadryl  3tsp q 4-6 hours. Return to clinic if unresolved. Pt didn't return for visit or return phone calls to him.									Y	10/27/2001	10/28/2001	1	CPK; CBC; CMP-all wnl	PUB	PUB	Humulin 70/30; Nexium 40mg; Zoloft 25mg	Diabetes Mellitus	Diabetes Mellitus, GERD, Depression			1						1	Hypokinesia; Muscular weakness; Swelling	FLU3~SANOFI PASTEUR~U0701AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0923L~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0179168	12/18/2001	ND	70.0	70		M	12/11/2001	The pt said his right arm was swollen down to his elbow and real sore. He said his arm got flabby like jello and he couldn't lift his arm above his waist. He said it hurt the day the vaccine was given and the next day and then it got better.									Y	11/15/2001	11/15/2001	0		PVT	OTH	NONE					1						1	Hypokinesia; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U0675AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0945K~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0179169	12/18/2001	OH	44.0	44		F	12/06/2001	Patient received the flu vaccine at her workplace(factory). It was administrated by personnel from DeKalb Memorial Hospital. A 5 1/2 x 4 1/2 cm redness lump developed									U	11/27/2001	11/29/2001	2		UNK	UNK						1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U0671DA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179170	12/18/2001	VA	42.0			M	12/03/2001	Post vax, the pt developed diarrhea and cramping. He also had a fever, nausea and dizziness. He had a ear infection and a head cold.				Y					N	10/22/2001	10/22/2001	0		OTH	OTH	pseudoephedrine; Benadryl	NONE	Chronic sinusitis			1						1	Diarrhoea; Dizziness; Ear disorder; Infection; Muscle spasms; Nasopharyngitis; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~IM~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0179171	12/18/2001	GA	44.0	44		F	12/11/2001	Pt developed a 3 X 3 red, warm and swollen area over the injection site with some swelling around axilla. It started the morning after the injection. Treated with warm and wet compresses.									Y	12/06/2001	12/07/2001	1		PUB	PUB	UNK	NONE	Respiratory problems			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~PFIZER\WYETH~4018054~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0923L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0179172	12/18/2001	NE	0.8	0	.9	F	12/11/2001	The pt developed a fever of 102F on Sunday after receiving the Flu-Shield on Saturday, 12/8/01. It is persisting despite Tylenol alternating with Motrin q 6 hours.				Y					Y	12/08/2001	12/09/2001	1		PVT	PVT	NONE	NONE	Frequent otitis media			1						1	Pyrexia	FLU3~PFIZER\WYETH~4018033~1~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0179173	12/18/2001	SD	56.0	56		F	12/06/2001	The pt had a flu shot on 12/4/01. She called on 12/6/01 and complained of redness, swelling and tenderness in her left upper arm where the injection was given. The pt came in to the clinic and I assessed her arm. Her upper left arm had a 3 by 2 patch of redness which was swollen, warm and tender to the touch. Recommended ice to site and to see her MD if it doesn't get better or if it gets worse.									U	12/04/2001	12/06/2001	2		PUB	OTH	Allergy shot taken once a week for environmental allergies	NONE	Environmental allergies (dogs, ragweed)		SD01007	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~PFIZER\WYETH~4018027~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0179194	12/18/2001	NH	1.0	1	.1	F	12/13/2001	12/06/2001 4:40 PM Benadryl 125 mg PO given at 4:55 PM.									Y	12/06/2001	12/06/2001	0	NONE	UNK	UNK	NONE	NONE	NONE			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1084L~1~IM~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0168258	12/19/2001	OH	41.0	41		F	12/12/2001	It was reported that an adult female pt received a Fluzone SV '00-'01 vaccination at the hospital on 11/20/00. Two weeks later, the pt developed transverse myelitis and became paralyzed. No other information was provided at this time. Further information has been requested. This experience was considered to be an Other Important Medical Event.									U	11/20/2000	12/03/2000	13		UNK	UNK					U2001012620	1						2	Cachexia; Faecal incontinence; Injection site pain; Myelitis transverse; Paraplegia; Urinary incontinence; Myelitis transverse; Paralysis	FLU3~AVENTIS PASTEUR~U0335AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~AVENTIS PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0179213	12/19/2001	WA	34.0	34		F	12/12/2001	Unexplained death. Awaiting autopsy COD as per autopsy report -- combination of methadone and oxycodone intoxication	Y	12/11/2001							N	12/10/2001	12/11/2001	1	Autopsy-pending	PVT	PVT			Sulfa allergy			1						1	Overdose	FLU3~SANOFI PASTEUR~UO708AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0179214	12/19/2001	OK	41.0			F	01/02/2002	It was reported that a 41 year old female pt received a dose of Fluzone SV '01-'02 on 10/30/01. On 11/20/01, the pt experienced numbness in her hand. On 11/27/01, she went to a hospital ER with shooting pains in her hand (reporter did not know which hand or if it was the same arm the dose of Fluzone was administered in). The pt was dx'd with brachial neuritis. This was considered to be an Other Important Medical Event. From follow up correspondence received on 1/2/02, it was confirmed that the numbness in the patient's hand occurred in the same arm that the Fluzone product was administered. The vaccine administrator and responsible physician information was also provided. 8/11/03: No additional info is anticipated. AE coding was changed. Brachial plexus neuropathy is listed in the labeling for the influenza vaccine. Case is closed.				Y					U	10/30/2001	11/20/2001	21	X-rays and blood work were done (no results were provided).	OTH	OTH					U2001012610	1						1	Hypoaesthesia; Neuropathy peripheral; Pain	FLU3~SANOFI PASTEUR~U0668AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179221	12/19/2001	CT	68.0	68		F	12/13/2001	Pt stated discomfort noted in L shoulder area 3-4 days after flu shot rec'd in L arm. Pt observed bruise in area near top of shoulder, but no swelling. States she experienced limited movement of L arm. Went to Dr 12/10/01 who diagnosed tendonitis and prescribed home exercises. Pt states now w/neck pain and states MD said this is related to the shoulder pain. Small flat purple discoloration seen today by me at top of L shoulder area.				Y					U	10/23/2001	10/26/2001	3		PUB	PUB			some arthritis		CT200109	1						1	Contusion; Discomfort; Joint range of motion decreased; Neck pain; Skin discolouration; Tendonitis	FLU3~SANOFI PASTEUR~U0597AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179222	12/19/2001	OH	45.0	45		F	12/11/2001	After hot bath following day -R thigh red, welted, tender approx 2 round circle - lasted 2 wks. No treatment									Y	11/23/2001	11/24/2001	1		PVT	OTH	Eftexol, Xanax, Trazadone, Biaxin XL	Bronchitis	sulfa, CP, depression			1						1	Injection site erythema; Tenderness; Urticaria	FLU3~SANOFI PASTEUR~U0725AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179223	12/19/2001	OH	63.0	63		F	12/12/2001	pain, bruised, red									Y	12/10/2001	12/10/2001	0	not applicable	OTH	OTH	Glucophage, Lodine Tagament		diabetes			1						1	Contusion; Erythema; Pain	FLU3~SANOFI PASTEUR~U0673BA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179224	12/19/2001	SC	70.0	69		M	12/12/2001	The patient experienced a sharp pain in his right arm upon any movement. he state it feels like the bone is injured. No swelling,redness, discoloration or warth were noted at/around the injection site. There was nothing to palpitate.									Y	10/23/2001	11/06/2001	14		PUB	OTH	UNK	None	UNK			1						1	Pain	FLU3~SANOFI PASTEUR~U0673BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1456K~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0179225	12/19/2001	CA	28.0	28		F		24 hrs post injection, felt itchy all over body, rash in patches all over. 48 hrs later symptoms exist, took Claritin (10mg) tablet.									Y	12/10/2001	12/11/2001	1		OTH	OTH	yasmin		Allergies: strawberries, shrimp, minocycline			1						1	Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0179226	12/19/2001	CT	11.0	11		M	12/13/2001	The pt had an onset of a erythematous, nodule, lesion at the site of the injection progressing to vesicular eruption about 24 hours, post vax. The lesion lasted for a week. It was treated with cool compresses. He has received Influenza vaccine yearly since 1992. No known egg allergy.									Y	11/23/2001	11/24/2001	1	Vesicular fluid sent for a viral culture and a bacterial culture and both were negative. He had a Tczanck Prep which also was negative.	PVT	OTH	Albuterol MD2; Baclofen; Dulcolax Supp; Ditropan; Renacidin irrigation; Senna; Sorbital; Dical-D	NONE	Spinal cord injury; ventilator dependent; autonomic dysreflexia secondary to spinal cord injury			1						1	Injection site erythema; Injection site mass; Rash vesicular	FLU3~SANOFI PASTEUR~U0678BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179227	12/19/2001	KS	47.0			F	11/15/2001	Found pt lying on floor in room, c/o being thirsty & appears to be hyperventilating. c/o tightness and extremities stiffening up. .5 of epinephrine given & 911 called BP 92/50, 180/102 post epi. EMS on seen & taken to hospital at 07:40.				Y					Y	11/15/2001	11/15/2001	0		OTH	PVT		NONE	NONE			1						1	Blood pressure increased; Hyperventilation; Musculoskeletal stiffness; Thirst	FLU3~SANOFI PASTEUR~U06735A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179228	12/19/2001	MD	45.0	45		F	12/14/2001	The same day I rec'd vaccine the following occurred  redness, swelling, tenderness @ deltoid area, febrile 101F, nausea, vomiting. All occurred within 8 hrs also severe headache  5pm. Then developed skin lesion on side of face near nose, which had trouble healing. Continued low grade fever and generalized malaise for 2 wks. Reported incident to private physician. My R deltoid remained swollen, tender for week.									Y	10/16/2001	10/16/2001	0		MIL	OTH	Synthroid, catapril	NONE	Migraine headache, discoid lupus, Hx thyroid goiter			1						1	Headache; Injection site erythema; Injection site swelling; Malaise; Nausea; Pyrexia; Skin ulcer; Tenderness; Vomiting	FLU3~SANOFI PASTEUR~U0597AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179229	12/19/2001		25.0	25		M	12/04/2001	reactive arthritis - diffuse joint pain & malaise				Y					N	11/27/2001			CBC, ESR,Negative	MIL	MIL		NONE	NONE			1						1	Arthralgia; Arthritis; Malaise	FLU3~SANOFI PASTEUR~U0674AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179230	12/19/2001	NY		23		F	11/28/2001	Given the Flu vaccine in the early PM of 10/31/2001. By 7:30 PM that evening pt states she had severe chills and a fever about 103. Severe flu symptoms. Still ill on 11/1/2001 chills and fever. Back to work 11/02/2001, feeling better. Did not go to MD.									Y	10/31/2001	10/31/2001	0		PUB	PVT		NONE				1						1	Chills; Influenza like illness; Pyrexia	FLU3~SANOFI PASTEUR~UO591CA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179231	12/19/2001	WA	72.0	72		M	12/13/2001	The pt may have had a mild Guillain-Barre. He was weak and couldn't squat. He recovered without any paralysis or neuro-sensory changes.									Y	11/23/2001	12/04/2001	11		PVT	PVT	Allopurinol; Prilosec; colchicine; Vasotec; ASA; atenolol; procainamide	NONE	None that should do this			1						1	Asthenia; Guillain-Barre syndrome; Hypokinesia	FLU3~SANOFI PASTEUR~U0699AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179232	12/19/2001	MD	51.0	51		F	12/10/2001	Post vax, the pt complained of hives all over her body with a pruritic erythematous rash all over body.									U	11/28/2001	12/07/2001	9	NONE	OTH	OTH			PCN causes edema			1						1	Erythema; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179233	12/19/2001	NH				F	12/16/2001	The pt developed a reddened, firm, warm and elevated area. Treatment with ice application.									Y	10/30/2001	11/01/2001	2		OTH	OTH		NONE				1						1	Injection site erythema; Injection site mass; Injection site warmth	FLU3~SANOFI PASTEUR~U0602BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179234	12/19/2001	NH				F	12/16/2001	The pt developed a quarter-sized reddened, slightly firm and warm area.									Y	10/30/2001	11/01/2001	2		OTH	OTH		NONE				1						1	Injection site erythema; Injection site induration; Injection site warmth	FLU3~SANOFI PASTEUR~U0602AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179235	12/19/2001	NH	38.0	38		F	12/16/2001	The pt developed vomiting and blood-shot eyes.									Y	10/31/2001	11/01/2001	1		MIL	OTH		NONE				1						1	Ocular hyperaemia; Vomiting	FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179236	12/19/2001	NH				F	12/18/2001	The pt developed a large, red and firm area, noted to be pink and diffuse.									Y	10/30/2001	11/01/2001	2		MIL	OTH		NONE				1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179237	12/19/2001	NH	25.0	25		F	12/18/2001	The injection site was hot, red and sore for a prolonged period of time.									Y	11/01/2001	11/04/2001	3		MIL	OTH		NONE				1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179238	12/19/2001	NH	49.0	48		F	12/16/2001	The pt developed a fever, lump on arm X 2 days, headache and weakness.									U	10/30/2001	11/02/2001	3		MIL	OTH		NONE				1						1	Asthenia; Headache; Injection site mass; Pyrexia	FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179239	12/19/2001	NH				F	12/16/2001	The pt developed a 4cm X 2cm reddened and slightly firm area. Treatment with ice application.									Y	10/30/2001	11/01/2001	2		OTH	OTH		NONE				1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179267	12/19/2001					F	12/12/2001	Hospital employee given influenza vaccine, then went home. Injection site became red, hot, raised (about 3 inches by 4 inches). Reported to infection control nurse on 12/12/2001. Still red and hot.										12/10/2001	12/10/2001	0		UNK	UNK						1						1	Injection site hypersensitivity; Vasodilation procedure	FLU3~PFIZER\WYETH~4018042~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0176447	12/20/2001	IL	57.0	56		F	12/12/2001	Pt presented at ER same day as flu shot with erythema, scattered hives, pruritis, throat swelling.				Y					Y	10/08/2001	12/08/2001	61		OTH	OTH	Diovan; Singulair; verapamil; Allegra; Premarin	NONE	Hypertension; Asthma; NKDA			1						2	Blood pressure increased; Flushing; Heart rate increased; Hypothermia; Pruritus; Respiratory rate increased; Stridor; Throat tightness; Erythema; Laryngospasm; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0591CA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0179079	12/20/2001	MI	59.0	59		F	12/03/2001	Pt. states first day hot, hard and itchy. second day hives under left o-- and spread to breasts & legs. third day arm very swollen, could not bend, hot to touch and very red. Went to ER on 12/01/01. given Benadryl, so				Y						11/28/2001	11/28/2001	0		PUB	PUB			Asthma		MI2001097	1						2	Injection site erythema; Injection site mass; Injection site swelling; Injection site warmth; Urticaria; Erythema; Feeling hot; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4018043~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4018043~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0179268	12/20/2001	SD	53.0	53		F	07/10/2002	A phamacist reported that a 53 year old female received an injection of Flu Shield on 29-NOV-2001. Within one hour of vaccination, the pt developed paresthesia in her right foot which traveled up her right side. She was hospitalized where an MRI showed transverse myelitis. No further information was available at the date of this report. The follow up states MRI of her spine showed a 1cm area of plaque at the T2 level. An MRI of the brain was normal. An analysis of her cerebrospinal fluid showed no abnormalities. A diagnosis of transverse myelitis was made. A visual evoked response potential test was normal. Somatosensory evoked potential of the posterior tibial area showed no reproducible cortical activity on the right. As of March 2002, the pt had nearly complete resolution of symptoms; however, she still complains of occasional episodes of tingling in the leg.					Y	2			U	11/29/2001	11/29/2001	0	MRI showed transverse myelitis-1cm plaque at T2 level; brain-normal	OTH	OTH	Atenolo; Maxzide	NONE	Hypercholesterolaemia; hypertension NOS; rosacea		HQ9443813DEC2001	1						1	Myelitis transverse; Paraesthesia	FLU3~PFIZER\WYETH~4018027~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0179285	12/20/2001		79.0			F		In 11/00, the pt was hospitalized due to leucocytoclastic vasculitis affecting skin and kidneys. Ovarian cancer was dx'd while in the hospital and the pt had a good response to chemotherapy (pallilative). The event resolved in 4/01 and the pt recovered. There was insufficient information to determine the reporter's causality assessment.					Y				Y	11/01/2000	11/01/2000	0		OTH	OTH	NONE				PJP2001003080	1						1	Ovarian cancer; Renal vasculitis; Vasculitis	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0179288	12/20/2001	NM	49.0	49		F	12/18/2001	12/17/2001 11:30 Rapid pulse, chills, shortness of breath, fatigue, malaise and fever  of 104 .took ASA and slept.									Y	12/07/2001	12/17/2001	10	N/A	OTH	UNK		HTN	Benadryl			1						1	Dyspnoea; Heart rate increased; Lethargy; Malaise; Pyrexia	FLU3~PFIZER\WYETH~4018046~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0179289	12/20/2001	NJ	59.0	59		F	12/17/2001	11/13/2001 *:00 am-Awakened with a headache, took two Advil tablets 8:30 headache 3:00 pm received the Flu vaccine 3:30 pm took two Tylenol tablets 6:30 pm  while changing clothes had red, very raised blotched areas from armpit and below, nipple line to neckline  7:00 pm took Benedryl 8:30 pm asleep to 11/14/2001 at 7:00 am, without rash.									Y	11/13/2001	11/13/2001	0		PUB	PVT	Fosama	None	None			1						1	Headache; Rash	FLU3~SANOFI PASTEUR~U0687EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179290	12/20/2001	MD	48.0	48		F	11/27/2001	Approx. 1 hours and 45 minutes, post vax, the pt experienced rapid heart beat, wheezing, congestion, heaviness in mid-chest. No history of asthma. The pt thought the room where symptoms occurred had a strong moldy smell. The time course was 45 minutes then wheezing stopped, congestion gone and heaviness had diminished. She refused treatment.									Y	11/06/2001	11/09/2001	3	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Chest pain; Heart rate increased; Nasal congestion; Wheezing	FLU3~SANOFI PASTEUR~U0694AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179312	12/21/2001	KY	72.0	72		F	12/06/2001	The pt developed generalized rash which started at noon on 12/05/01. Flu shot given at 09:00 on 12/5/01.									U	12/05/2001	12/05/2001	0		PUB	PUB	Lipitor; Claritin; Zoloft; nadolol		Allergic to sulfa and other allergies.		KY2001093	1						1	Rash	FLU3~EVANS VACCINES~E12451MA~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0179313	12/21/2001	FL	76.0	76		F	12/14/2001	The pt developed a severe local reaction. Entire upper arm edema, induration, heat, erythema and pain. Her husband had the identical reaction from the same vial. Also, she had a systemic fever X 24 hours.									Y	12/04/2001	12/04/2001	0	NONE	PVT	PVT	Fosamax; valium	NONE	Allergy to codeine and Demerol			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U0684AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0994L~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0179314	12/21/2001	NY	47.0	47		M	12/14/2001	About 5 days, post vax, the pt developed neck pain radiating into his left scapula, left deltoid and left axilla. No symptoms in the days immediately following the administration of the vaccine. Still symptomatic.									N	11/06/2001	11/11/2001	5	NONE	OTH	PVT	Atenolol; Naproxen; Ecotrin; Vitamin B1; Multivitamins	NONE	History of CVA; history of MI; chronic cervical spine problems			1						1	Injection site pain; Neck pain; Pain	FLU3~EVANS VACCINES~E04851KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0179315	12/21/2001	PA	46.0	46		F	12/14/2001	5 minutes, post vax, the pt developed a rash to her torso (front and back). Her BP was increased at 170/90 and pulse increased at 120. Her lungs were clear and she denied shortness of breath. No pharyngeal edema noted. Her vital signs returned to baseline after 15 minutes. Observed for 45 minutes.									Y	12/13/2001	12/13/2001	0		PVT	PVT			Iodine allergy			1						1	Blood pressure increased; Heart rate increased; Rash	FLU3~SANOFI PASTEUR~U0717AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179316	12/21/2001	PA	49.0	49		F	12/16/2001	The pt developed a hot fever, throwing up and a headache. Her husband called the hospital.									Y	11/07/2001	11/08/2001	1	NONE	PUB	PUB	Advair	NONE	Asthma; allergy to penicillin, lint, dust and lima beans			1						1	Headache; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~IM~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0179317	12/21/2001	MA	52.0	62		F	12/14/2001	The pt developed chills, headache and a fast heartbeat which started last night (12/13/01). She still has a headache and chills and feel tired. Fast heart beat is resolved. Called my family physician to report and then notified Employee Health.									Y	12/13/2001	12/13/2001	0		PUB	PVT		NONE	Pt had allergy shots 2 weeks prior to vaccination; Asthma; environmental allergies (oak, pine, maple, dust and mold)			1						1	Chills; Fatigue; Headache; Heart rate increased	FLU3~PFIZER\WYETH~4018033~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0179318	12/21/2001	CO	78.0	78		M	10/26/2001	The pt developed a fever, chills, nausea and vomiting. Dx'd with labyrinthitis and rx'd meclizine and compazine.				Y					Y	10/23/2001	10/26/2001	3	CBC: WBC-8.3; S 82.6%; Bands 5%; Lymphs 4%	PUB	OTH		NONE	NONE			1						1	Labyrinthitis; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U0588AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179319	12/21/2001	TX	33.0	33		F	11/20/2001	The client attended a health clinic at a community center on 11/14/01 where she received a TD booster. She complained of swelling to the left arm, face and neck. She was seen be an RN at the office at 15:30. Her left arm had redness to the deltoid area of approx. 2 in diameter with moderate swelling. No swelling to face, neck or chest, as she had stated. Her arm was warm to touch. Advised her to apply warm and wet soaks.				Y					U	11/14/2001	11/15/2001	1		OTH	PUB	NONE	NONE	NONE		TX01180	1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U0588AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~U0147AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0179152	12/26/2001	GA	31.0	31		F	12/10/2001	Left upper extremity cellulitis immune reaction to stated vaccinations given on 12/7/01.					Y				Y	12/07/2001	12/09/2001	2	NIDDM; Dyspepsia; Irritable Bowel; Hemorrhoids; ???	UNK	UNK	Paxil, Xenical		Morbid obesity			1						2	Erythema; Cellulitis	FLU3~PFIZER\WYETH~4018037~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~PFIZER\WYETH~4018037~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0179357	12/26/2001	PA	26.0	26		M	12/18/2001	It was reported that a 26 year old male pt received a dose of Fluzone SV '01-'02 on 12/6/01 at noon. The dose was given in his right deltoid. The pt has been previously immunized with influenza vaccine once prior (2 years ago). At approx. 21:00, on 12/6/01, he began to feel numbness in his face and he could not shut his eye and had difficulty moving his facial muscles on one side. The pt was evaluated by an MD on 12/7/01. No dx as of yet. The pt now has slurred speech and is planning to see another physician for a second opinion.				Y					U	12/06/2001	12/06/2001	0		UNK	UNK					U2001012640	1						1	Dysarthria; Hypoaesthesia; Muscular weakness; Ophthalmoplegia	FLU3~SANOFI PASTEUR~~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179358	12/26/2001		11.0	11		M	12/11/2001	On 13-NOV-2001, the pt received a Fluvirin injection IM on the left deltoid muscle. On the morning of the next day, the pt experienced an asthma attack on 15-NOV-2001. The reporter provided no information on the inpatient therapy regimen. The pt was discharged from hospital on 19-NOV-2001 and has recovered. The reporter assessed the relationship of study medication to the event as possible. Also stated event may have contributed to by the pt's medical history.					Y	4			Y	11/13/2001	11/14/2001	1		UNK	UNK	Unknown (oral) asthma medication		Asthma		PJP2001004670	1						1	Asthma; Condition aggravated	FLU3~EVANS VACCINES~E06731KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0179362	12/26/2001	CA	49.0	49		F	12/18/2001	Pt received flu vaccine on 12/14/2001. Now with erythema and blistering 1.5 cm by 1.5 cm at injection site.									Y	12/14/2001	12/16/2001	2	NONE	PVT	PVT	NONE	NONE	Allergy to sulfa causes rash			1						1	Blister; Erythema; Injection site reaction	FLU3~SANOFI PASTEUR~UA682AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179363	12/26/2001	NY	51.0	51		M	12/17/2001	Several days post injection bilateral hip aches down legs, getting better.									N	12/06/2001	12/08/2001	2		OTH	PVT	NONE	NONE	NONE			1						1	Pain	FLU3~PFIZER\WYETH~4018044~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0179364	12/26/2001	SC	58.0	58		F	12/17/2001	After injection, approximately 6 hours, left deltoid began hurting, then turned red and swollen at site, raised 1/4, not hard, centered, it stayed about 18 hours. Client did not apply ice or any treatment, thereafter it went away without difficulty.									Y	11/26/2001	11/26/2001	0	NONE	PUB	PUB	Premarin	NONE	NONE			1						1	Injection site hypersensitivity; Oedema; Pain; Rash maculo-papular	FLU3~SANOFI PASTEUR~UO673GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179365	12/26/2001	CA	54.0	54		F	12/13/2001	Parasthesias left arm post flu shot.									U	11/15/2001	11/17/2001	2		PVT	PVT	NONE	NONE				1						1	Paraesthesia	FLU3~SANOFI PASTEUR~UO712AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179366	12/26/2001	MD	34.0	34		M	11/02/2001	Sore arm and throat, feverish feeling 30-45 minutes after immunizations. Temperature 100 F. No cough, no dysnea, no paresthesias and no pint swelling.				Y						11/01/2001	11/01/2001	0		UNK	UNK		NONE	NONE			1						1	Pain; Pharyngitis; Pyrexia	FLU3~SANOFI PASTEUR~UO674AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0028L~2~IM~~HEP B (RECOMBIVAX HB)~1|HEPA~MERCK & CO. INC.~0900K~2~IM~~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0179367	12/26/2001	GA	62.0	62		M	12/14/2001	Patient complained of redness and swelling at site extending to elbow. Patient received injection in right arm. Pt stated he can hardly bend his arm and it is painful. Symptoms began the same evening of receiving the injection. Instructed pt when he reported symptoms on 12/14/2001 to apply warm compresses to arm and take Tylenol or Motrin for pain.									U	12/12/2001	12/12/2001	0		MIL	MIL						1						1	Injection site hypersensitivity; Joint range of motion decreased; Oedema; Pain	FLU3~SANOFI PASTEUR~OU704AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1352L~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0179368	12/26/2001	MA	50.0	50		F	12/07/2001	Vaccine administered 11/19/2001. Symptoms began 11/20/2001; achy, feeling of coming down with something. Head cold symptoms for 2 days, weakness and pain in all four extremities for 7 days, frequent, spontaneous sweats; minor sore throat and difficulty breathing. Sweats, SOB still present on 12/07.									U	11/19/2001	11/20/2001	1	CXR-positive; PFT-negative	PVT	PVT	NONE	NONE	PCN, Sulfa and back surgery three times			1						1	Dyspnoea; Hyperhidrosis; Malaise; Pain; Pharyngitis; Rhinitis	FLU3~SANOFI PASTEUR~UO670AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179369	12/26/2001	NC	71.0	71		M		Fever 102, nausea, swollen arm/shoulder for 3 days, chills and shoulder/arm sore for 3 days.				Y					Y	10/25/2001	10/25/2001	0		PUB	PUB	NONE	NONE	NONE			1						1	Chills; Nausea; Oedema; Pain; Pyrexia	FLU3~EVANS VACCINES~E027811HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1448K~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0179370	12/26/2001	NH	45.0	45		M	12/21/2001	At 1:30 PM pt was weak and feverish. At 2:30 PM pt took Tylenol and went to sleep. Did not take temperature. At 5 PM felt fine.									Y	11/20/2001	11/20/2001	0	NONE	PUB	PUB	NONE	NONE	NONE		NH0126	1						1	Asthenia; Pyrexia	FLU3~SANOFI PASTEUR~UO690AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179404	12/26/2001	NJ	56.0	56		F	12/01/2001	The pt developed chills, muscle aches, headache, stomach pain and fever which started 18 hours, post vax, and lasted about 3 days. Then she had a lot of sweating. She relapsed on 11/26/01 and had similar symptoms with joint pain and weakening in muscles.				Y					N	11/19/2001	11/20/2001	1		PVT	PVT	Cozaar; zinc; Prilosec; Claritin; Celebrex; Flonase; Quinine sulfa; Xanax	NONE	High blood pressure; gastro-reflux; arthritis; nasal allergy; leg cramps			1						1	Abdominal pain upper; Arthralgia; Headache; Hyperhidrosis; Muscular weakness; Myalgia; Pyrexia	FLU3~EVANS VACCINES~E08341LA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0179428	12/27/2001	FL	66.0	66		F	12/06/2001	The pts were administered the flu vaccine and the pneumococcal vaccine after obtaining informed consent, between 08:30-09:00. Later that day, the ER physician called stating that 2 pts were being admitted into the hospital with hypoglycemia. It was reported that both pts blood sugars were in the 40's with signs and symptoms of hypoglycemia. The ER/hospital progress notes were unavailable at the time of this report. There was no history of diabetes in either pt.				Y	Y				U	12/06/2001	12/06/2001	0	Blood sugars-in the 40's	OTH	OTH						1						1	Hypoglycaemia	FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0501~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0179435	12/27/2001	MA				F	12/14/2001	pain and stiffness in the area where the shot was given									Y	12/14/2001	12/14/2001	0	P 72 BP 160/80 R 121 ROM intact no numbness in fingers	PUB	PUB	buffered ASA	None	None			1						1	Blood pressure increased; Injection site pain; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U0571AD~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179436	12/27/2001	DC	66.0	66		F	11/07/2001	Pt with 2 month history of intermittent shaking chills on multiple meds status post liver transplant 6 years ago. Ten minutes after shot developed lightheadedness, shaking chills similar to prior episodes associated with moderate hypotension and bradycardia, supine position, observation, self-medication with valium, resolved in one hour.									Y	11/07/2001	11/07/2001	0		MIL	UNK		NONE	Six years post liver transplant			1						1	Bradycardia; Chills; Dizziness; Hypotension; Tremor	FLU3~SANOFI PASTEUR~UO704AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179437	12/27/2001	NY	11.0	11		M	12/20/2001	half hour after receiving vaccine, the patient complained of their right thumb and index finger tingly. patient is right handed. Examined 11/21/2001. positive Tinel's sign, positive FH of Carpel Tunnel. Plays hockey and shoots left handed. also does a little computer work.				Y					U	11/01/2001	11/01/2001	0	EMG=R median neuropathy carpel tunnel syndrome	PVT	PVT	albuterol		lactase deficiency			1						1	Carpal tunnel syndrome; Neuropathy; Paraesthesia	FLU3~SANOFI PASTEUR~U0600AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179438	12/27/2001	CA				U		Right arm swelled in evening 2 times normal, fever. Went to bed. Late 2nd day felt normal. It moved from arm inside chest to back and up. 11/08/2001 3 PM Local drug store had flu and pneumonia vaccines.									Y	11/08/2001	11/08/2001	0		OTH	PUB	NONE	NONE	NONE	swelling~Pneumo (no brand name)~1~77.00~In Patient		1						1	Injection site swelling; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0179439	12/27/2001	OR	42.0	42		F	12/16/2001	Pain immediately upon injection. Severe tenderness, achy pain, swelling from shoulder to elbow within 2 hours. By 3 hours, unable to lift arm. Severe nausea difficulty breathing. Arm red, feverish to fingers. As of 12/16/2001, persistent joint pain/ache, but swelling better.									U	12/12/2001	12/12/2001	0		OTH	PVT	Alesse 28; Singulair; Zyrtd; Effexor	NONE	Inhalitory(aspegillis, phenol, rodent dander), Food (beef and mango).			1						1	Dyspnoea; Erythema; Joint range of motion decreased; Nausea; Oedema; Pain; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~UO681AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1351L~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0179440	12/27/2001	VA	59.0	59		F	12/21/2001	On 10/29/2001 at 10:30 AM administered vaccine (flu). By 10:55 AM pt became sick to stomach, weak, diarrhea, no vomiting. By 11 AM weak, warm, diaphoretic, quite pink all over. Unable to hear BP. No respiratory distress, no hives, no localized reaction at site. Poorly responsive. Sent to ER via ambulance.				Y					N	11/29/2001	11/29/2001	0	Atrial fibrillation labs and Halter monitor.	OTH	OTH	NONE	Stomach Virus	NONE			1						1	Asthenia; Stomach discomfort	FLU3~PFIZER\WYETH~4018027~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0179441	12/27/2001	MN	42.0	42		M	12/14/2001	Temp spikes to 103.5 for 24 hours. Sweats, myalgias and malaise.										12/13/2001	12/13/2001	0	WBC 8,100	PVT	PVT		NONE	No allergies, right seapular winging, atospermia, impotence, pipe smoker			1						1	Hyperhidrosis; Malaise; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~UO727AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~473566~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0179442	12/27/2001	CA	74.0	74		M	12/18/2001	Day one joint pain, sore throat, hard to breathe. Day two congestion and fever. Day three headache and cough. Symptoms continued for 20 days.									Y	12/06/2001	12/07/2001	1	NONE	PVT	PVT		NONE	Hay fever, morphine, tape, demerol and has gout.			1						1	Arthralgia; Cough; Headache; Pharyngitis; Pyrexia; Rhinitis	FLU3~SANOFI PASTEUR~UO676AA~7+~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179443	12/27/2001	MI	79.0	78		M	12/17/2001	Pt was seen by eye doctor 3 days after receiving flu shot with complaint of blurry vision. Eye doctor diagnosed pt with a swollen optic nerve. Pt treated with steroids.									Y	10/26/2001	10/29/2001	3	MRI negative for any cause for swollen optic nerve.	PUB	PUB		NONE	NONE			1						1	Oedema; Vision blurred	FLU3~SANOFI PASTEUR~UO602BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179444	12/27/2001	AL	44.0	44		F	12/19/2001	Ten minutes after the Flu shot, I had sever pain in my entire left arm. The next morning, I had swollen lymph nodes and a lot of swelling in my neck. Left side pain continued for 5-7 days. Swelling 6 weeks. Still swelling in neck.				Y					N	10/30/2001	10/30/2001	0		PVT	OTH		NONE	Codeine, Bactrium, Erytmomicin, Fibromyalgia			1						1	Lymphadenopathy; Oedema; Pain	FLU3~SANOFI PASTEUR~UO5908A~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179445	12/27/2001	IN	23.0	23		F	12/19/2001	Redness local irritation soreness at site. Onset at 3:05 PM. Gave pt cold pack to applyat site for local soreness. Informed pt to notify physician.									Y	12/19/2001	12/19/2001	0		OTH	UNK						1						1	Erythema; Injection site hypersensitivity; Pain	FLU3~SANOFI PASTEUR~UO596DA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179446	12/27/2001	IN	32.0	32		M	12/19/2001	Pt presented with rash present on neck and anterior chest at approximately 3:55 PM. Called MD. Physician instructed to give pt the chleranin tablets in Epi kit. At 4 PM save pt tabs to take. Explained to pt that it was antihistamine could present drowsiness. Call if respiratory problems occur.									Y	12/19/2001	12/19/2001	0	NONE	OTH	UNK		NONE	PCN			1						1	Rash	FLU3~SANOFI PASTEUR~UO596DA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179447	12/27/2001	WV	45.0	45		F	11/30/2001	Two hours after site became red, hot, swollen and itching. Hives developed on left arm and chest. She had URI 2 weeks prior. Has chronic smokers cough. Wheezing returned after flu shot. Advised her to see her physician, use cold packs, ibuprofen for pain, hydrocortisone for itching. By 11/29/2001 had 5 inch indurated area, had not called or seen doctor.				Y					Y	11/26/2001	11/26/2001	0	NONE	PUB	PUB	Calritin D	URI	Allergic to codeine, emycin, Benadryl, Robitussin, PPD, wools, strawberries/ Syncope			1						1	Cough; Injection site hypersensitivity; Injection site induration; Pruritus; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~UO696AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179448	12/27/2001	CA	64.0	64		F	12/11/2001	Pt called 12/10/2001 in the morning stated after few hours of flu shot pt was very sick over the weekend like hoarseness voice, fever, moderately wheezing on her lungs, coughing and body weakness for three days. Pt stated never felt like thi before with previous flu shot. Pt stated felt very sick until today 12/20/2001.										12/07/2001	12/07/2001	0		PUB	PUB	NONE	NONE			CA010137	1						1	Asthenia; Cough; Dysphonia; Pyrexia; Wheezing	FLU3~SANOFI PASTEUR~UO705AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179449	12/27/2001	MI	47.0	47		M	12/18/2001	12/08/2001 Left deltoid swollen and sore. Left ear and left side of neck swollen, painful and reddened. red, raised rash on left, neck and into hair, still apparent on 12/11/2001. No swelling on deltoid area or shoulder. Afebrile. Referred to physician.				Y					U	12/07/2001	12/08/2001	1		PUB	PUB	NONE	NONE	NONE		MI2001101	1						1	Erythema; Oedema; Pain; Rash maculo-papular	FLU3~PFIZER\WYETH~4018037~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0179502	12/27/2001	IN		25		F	12/10/2001	Twenty-five minutes after vaccination pt complained of redness at site, slight itching. Examine sight, no local swelling. Local irritation. Gave pt ice pack, re-examined pt before I left pt was fine.									Y	12/06/2001	12/06/2001	0		OTH	UNK		NONE	Allergy to PCN			1						1	Injection site hypersensitivity; Pruritus; Skin irritation	FLU3~SANOFI PASTEUR~UO596DA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179507	12/27/2001	TN	73.0	73		M		On 10/29/2001 pt received pneumococcal and flu vaccines. Developed swelling, redness, pain and fever at pneumococcal injection site. Flu vaccine was given in opposite arm without problem. Medical record flagged for no future doses of pneumococcal vaccine. Report filed with FDA.										10/29/2001	10/29/2001	0	NONE	UNK	UNK	NONE		BPH			1						1	Injection site hypersensitivity; Oedema; Pain; Pyrexia	FLU3~EVANS VACCINES~E67330KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0179524	12/28/2001	NJ	54.0	53		M	12/13/2001	See hospital records and Neurologist report. (none attached)				Y	Y	10		Y	N	12/08/2000	12/20/2000	12		PVT	UNK	Glucotrol; Atenolol; Norvasc; Minitran; Plavix; Zestril; Lipitor; Nitrostat; ASA	NONE	NIDDM; Hyperlipidemia; CAD			1						1	Demyelination	FLU3~PFIZER\WYETH~4008178~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0179526	12/28/2001	NC	54.0	54		M	12/20/2001	Pt developed severe headache 6 days after receiving flu vaccine (11/15). On 11/16 began to notice decreased vision in right eye. Went to ER. Over next several days, lost vision both eyes. Headache continued until 11/29. Hospitalized on 11/27. Treated with steroids. now beginning to regain some vision.					Y	5			Y	11/09/2001	11/15/2001	6	MRI-wnl; LP fluid-wnl; CT Scan of head-wnl (11/16/01)	OTH	PVT	NONE	Sinus infection	Arthritis			1						1	Blindness; Headache	FLU3~EVANS VACCINES~E06741LA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0179528	12/28/2001	ID	66.0	66		F		Swelling of right arm, tightness in chest, Couldn't hardly breathe, every bone in body ached, fever off and on for three days. Treatment by MD, put ice on arm and take Tylenol.				Y					Y	10/31/2001				OTH	UNK	PPV	NONE	NONE			1						1	Chest pain; Dyspnoea; Oedema; Pain; Pyrexia	FLU3~SANOFI PASTEUR~UO601AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179529	12/28/2001	WA	56.0	56		M	12/16/2001	Became ill 1 hour after receiving injection has missed 10 days of work from 11/21/2001-12/16/2001 complained of fatigue, nausea, SOB and cough. Cough causes and diminishes and breathlessness and vomiting. Still having SOB and fatigue. Body aches.									U	11/12/2001	11/12/2001	0	CXR-negative	MIL	OTH		NONE	Seasonal allergies	severely ill~Influenza (Seasonal) (no brand name)~1~31.00~In Patient		1						1	Cough; Dyspnoea; Fatigue; Nausea; Pain; Vomiting	FLU3~SANOFI PASTEUR~UO671EA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179531	12/28/2001	MD	55.0	55		F	12/13/2001	12/4/2001 Immunized. 12/10/2001 Pain in deltoid area with swelling, redness 7 cm in area. 12/11/2001 Pain returned to shoulder, elbow, clavicle and shoulder blade. 12/13/2001 Saw MD.				Y						12/04/2001	12/10/2001	6		PUB	PUB		NONE	Tuberous Sclerosis; Sixth cranial nerve palsy			1						1	Erythema; Oedema; Pain	FLU3~PFIZER\WYETH~4018043~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0179532	12/28/2001	NY	26.0	26		M	12/19/2001	Localized reaction, red, hot swollen, pain in triceps with internal rotation of arm morning of 12/13/2001. Friday 12/14/2001 saw personal physician, gave him Zyrtec, drew circle around reddened area, told pt to return if swelling extended beyond circle. Revisit to MD, put him on 3 days of antibiotic, doesn't remember name.				Y					Y	12/12/2001	12/13/2001	1	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Injection site hypersensitivity; Oedema; Pain	FLU3~SANOFI PASTEUR~UO710AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179533	12/28/2001	TX	63.0	63		F	12/20/2001	Day received 11/07/2001 Evening achy arm, itch, red, slight swelling. 11/08/2001 Same as above but with welts from inside elbow to injection site, slight fever 100. 11/09/2001 Same as abve but less so. Right arm pneumonia.									Y	11/07/2001	11/07/2001	0		PUB	OTH	Premarin; Celebrex; Neurotin; Propecia: vitamins	NONE	Thyroid surgery			1						1	Erythema; Oedema; Pruritus; Pyrexia; Urticaria	FLU3~EVANS VACCINES~E06731KA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1449K~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0179534	12/28/2001	RI	67.0	67		F	11/20/2001	11/16/2001 pt had flu hot  and within 24 hours developed Iritis. diagnosed and treated by a Opthamologist.									Y	11/16/2001	11/17/2001	1		PUB	PVT		NONE	UNK	iritis~Vaccine not specified (no brand name)~~0.00~In Patient		1						1	Iritis	FLU3~SANOFI PASTEUR~UO703AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179535	12/28/2001	NY	60.0	60		M	12/20/2001	Aches all over body, fevers, pain urinating, runny nose, frequent urination.									Y	12/17/2001	12/17/2001	0		PUB	OTH	Aldomet; Water pill	Hypertension	Hypertension			1						1	Pain; Pollakiuria; Pyrexia; Rhinitis	FLU3~PFIZER\WYETH~UO986011~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0179536	12/28/2001	MA	43.0			F	12/06/2001	Twenty-four hours after receiving shot experienced hives.									Y	12/01/2001	12/02/2001	1		PUB	PUB						1						1	Urticaria	FLU3~SANOFI PASTEUR~UO676AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179576	12/28/2001	IL	71.0	71		M		The pt had a PMH of ITP in 1998 during his adjuvant chemotherapy for colorectal cancer. , treated with IGIV. Two weeks, post vax, he presented with recurrent ITP. The pt complained of bruising. He was treated with WinRho, prednisone and platelet transfusion. He is currently taking 60mg of prednisone. In 17 years of clinical practice, I don't ever recall seeing ITP related to influenza vaccine. Seeing 2 pts in the same week was more than a coincidence for me. I thought this would be of interest to you.				Y					U	11/05/2001	11/19/2001	14	CBC-nml hemoglobin and hematocrit; platelet count-o	OTH	OTH		Follow-up adjuvant colon cancer				1						1	Contusion; Platelet count decreased; Thrombocytopenic purpura	FLU3~SANOFI PASTEUR~U0694AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179733	12/29/2001	VT	52.0	52		F	12/29/2001	Patient c/o of painful cardiac palpitations, some SOB, lightheadedness and weakness (mod), which required her to sit and rest about 15 minutes.									Y	10/31/2001	10/31/2001	0		PVT	PVT	HRT	None	Amoxicillian			1						1	Asthenia; Chest pain; Dizziness; Dyspnoea; Palpitations	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179580	12/31/2001	TN	64.0	64		M	12/19/2001	On 10/29/2001 Pt received Flu vaccine at approximately 1200. Pt has received flu immunization for many years without incident. Approximately 18 hours post flu vaccine pt has fever. Approximately 24 hours post vaccination pt becomes dizzy and has difficulty walking. Weakness progresses but pt waits until following week to see neurologist. At that office visit pt received Solu-Medrol infusion followed by 1 week of oral prednisone. Exacerbation of MS lasted in totality about 2.5 weeks and did not resolve until completion of oral prednisone. Pt's spouse decided that her husband should not receive the flu shot in the future.									Y	10/29/2001	10/30/2001	1		UNK	UNK	Avonex		Multiple sclerosis			1						1	Asthenia; Difficulty in walking; Dizziness; Multiple sclerosis; Pyrexia	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0179581	12/31/2001	CA	71.0	71		F		Fever 102.7 F, runny nose, sore throat, body aches. Had bloody nose 5 days, discontinued 81 mg aspirin per doctor instruction. Severe fatigue and body aches, no appetite, stomach upset.									Y	10/31/2001	10/31/2001	0		OTH	OTH						1						1	Anorexia; Epistaxis; Fatigue; Pain; Pharyngitis; Pyrexia; Rhinitis; Stomach discomfort	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0179582	12/31/2001	MA	56.0	56		F	12/19/2001	Swollen, red 3.5 by 4 inch induration right arm.									U	12/18/2001	12/18/2001	0		PUB	PUB	NONE	NONE			MA0106	1						1	Injection site hypersensitivity; Injection site induration; Oedema	FLUX~UNKNOWN MANUFACTURER~~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~SC~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0179583	12/31/2001	MA	53.0	53		M	12/17/2001	Two to three days after flu vaccination case developed bilateral tingling hands and feet, more pronounced when flexing neck.				Y					U	11/01/2001	11/03/2001	2	MRI cervical-diagnosis lesion C2 demyelinating; MRI brain-negative; Spinal tap pending.	PUB	PUB	Liptor, ASA	NONE	Seasonal Allergies		MA0107	1						1	Demyelination; Paraesthesia; Skin ulcer	FLU3~SANOFI PASTEUR~UO676AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179584	12/31/2001	MA	37.0	36		F	12/06/2001	12/04/2001 5:30 AM woke up with sore neck, puffy eyes; fatigue, achy, nausea, sore throat and later that day complained of chills. Took two Tylenol at 6 AM, noon and 5 PM on 12/04/2001. 12/05/2001 Still with nasal complaints, no sneezing, but neck still sore. Continued 2 Tylenol every 4 hours. Did not call PCP but did see chiropractor for sore neck with relief by Friday 12/07/2001 symptoms were gone.									Y	12/03/2001	12/04/2001	1	NONE	PUB	PUB	NONE	Sneezing and stuffy	NONE		MA0108	1						1	Eye swelling; Fatigue; Nausea; Neck pain; Pharyngitis	FLU3~SANOFI PASTEUR~UA0676AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179585	12/31/2001	MA	53.0	58		F	12/17/2001	1:05 PM Five minutes after injection complained of lightheadedness, slight numb feeling left arm. Reseolved after sitting for 20 minutes (Opened outside door to increased air in room). After 20 minutes pt wanted leave, RN walked outside. Pt states she is going to PCP for complaint of hip pain which she had prior to immunization. At 2 PM at increased numbness in left arm, white lips, swollen lips. Given O2, EKG by physician. No epinephrine given by MD. Resolved on own. Pt also had lobster salad for lunch 1/2 prior to immunization. Never had a problem before. Advised to never have flu vaccine. Telephone call on 12/19/2001, pt feeling much better.				Y					Y	12/06/2001	12/06/2001	0	NONE	PUB	PUB	Estrogen	Left hip pain	NONE		MA0109	1						1	Arthralgia; Dizziness; Hypoaesthesia; Skin discolouration; Swelling face	FLU3~SANOFI PASTEUR~UA0676AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179615	01/02/2002	WV	38.0	38		F	12/21/2001	light red rash on chest and arms. Benadryl 50 mg po given. epenephrine (1:1000)) 1 dose given IM				Y					Y	11/01/2001	11/01/2001	0	none	PUB	PUB	None	none	allergic to goose feathers			1						1	Rash	FLU3~SANOFI PASTEUR~U0682AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179616	01/02/2002	KY	69.0	69		F	12/26/2001	Approximately 5 minutes after receiving flu and pneumonia vaccine pt began hollering, Oh, Oh my neck is hurting. Feels like a knot in my throat, a medicine taste. Complained of chest pain moving to back and leg numbness.				Y					Y	12/26/2001	12/26/2001	0	BP 240/110: Resp 32: Pulse 80	PUB	OTH	UNK	NONE	NKDA			1						1	Back pain; Chest pain; Dysgeusia; Hypertension; Neck pain; Pain; Respiratory rate increased; Throat tightness	FLU3~PFIZER\WYETH~481046~2~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1160L~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0179617	01/02/2002	OH	77.0	77		M	12/21/2001	Demyelinating disease; dizziness, blurred vision; difficulty hearing and walking.					Y	7			Y	11/19/2001	12/01/2001	12	CT Scan	PVT	UNK	Lipid; Vasotec; avandia; humilin; Tylenol; Zantac		IODM; Hyperlipidemia; Anemia			1						1	Demyelination; Difficulty in walking; Dizziness; Hearing impaired; Vision blurred	FLU3~EVANS VACCINES~E06221KA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0179618	01/02/2002	CO	7.0	7		M	11/23/2001	Local swelling, redness, itching started on arm 4-6 hours after flu vaccine administration. No fever, dysphagia, wheeze, SOB or any systemic symptoms.				Y						11/21/2001	11/21/2001	0		OTH	UNK		NONE	NONE	Local reaction~Influenza (Seasonal) (no brand name)~5~4.00~In Patient		1						1	Injection site erythema; Injection site swelling; Pruritus	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0179619	01/02/2002	PA	50.0			F	12/20/2001	Pt presented to ER complaining of swelling in hands and lips; Bilateral hand paresthesia, tightness in throat and chest. Treatment: Pepcid, SoluMedrol. Home: Medrol Desepak and Zyrtec.				Y						11/30/2001	11/30/2001	0	EKG	UNK	UNK	Vioxx					1						1	Chest discomfort; Oedema; Paraesthesia; Throat tightness	FLU3~SANOFI PASTEUR~U0671FA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179620	01/02/2002	PA	74.0	74		F	12/22/2001	Immediate pain, redness. In about 1 hour shot raised about 1 inch round lump and pain continued. In a few hours 1/3 upper arm turned black and blue and pain continued. Next day and for two additional days movement in upper right arm caused radiated pain. Lump disappeared in one week. Discoloration faded and disappeared in three weeks.									Y	11/19/2001	11/19/2001	0	NONE	OTH	PUB	NONE	NONE	NONE			1						1	Contusion; Injection site erythema; Injection site mass; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0179666	01/03/2002	OK	58.0	58		F		Patient c/o very sore left arm. she states that she can't lift it without pain.									U	12/01/2001	12/01/2001	0		PUB	UNK	Thyroid	NONE	Thyroid			1						1	Hypokinesia; Myalgia	FLUX~UNKNOWN MANUFACTURER~4018024~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0179670	01/03/2002	MA	94.0	93		F	12/23/2001	Vaccinated 8 PM 11/30/2001. Retired at 10 PM. Slept until 9 AM December 1. Felt very tired and needed more sleep. Managed to get around very wobbly, light headed and sleepy. Had lunch at 12 noon, still tired and sleepy. Finally went to bed and slept soundly until 4:30 PM. After rising I felt better and was fine for remainder of night.									Y	11/30/2001	12/01/2001	1		PUB	UNK	Paxil and Cozarr					1						1	Dizziness; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0179671	01/03/2002	OK	59.0	59		M	12/21/2001	Tingling in index and second finger in left hand. Fells like fingers are asleep.									U	12/06/2001	12/09/2001	3	NONE	MIL	MIL	UNK		NONE			1						1	Paraesthesia	FLU3~SANOFI PASTEUR~UO704AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179672	01/03/2002	OK	69.0	64		F	12/21/2001	Soreness in the left arm lasting from 09-DEC-2001 and still unresolved on 21-DEC-2001.									U	12/06/2001	12/09/2001	3		MIL	MIL	UNK	NONE	NONE			1						1	Pain	FLU3~SANOFI PASTEUR~UO704AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179673	01/03/2002	MO	63.0	63		M	12/26/2001	Received vaccine on Tuesday AM. Saturday at 4 AM woke up and couldn't talk and had trouble breathing. Worst head and chest cold ever had. I am seldom sick. First cold in 15 years. I am still coughing and spitting with trouble sleeping because of breathing difficulty, one month later.									U	11/27/2001	12/01/2001	4		OTH	UNK	NONE	NONE	NONE			1						1	Cough; Dyspnoea; Pharyngitis; Rhinitis; Speech disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0179674	01/03/2002	MO	64.0	63		F	12/26/2001	Received shot on Tuesday AM. Saturday AM problems breathing and talking. Continued on to a very bad head and chest cold with fever and headaches. I am rarely sick and never this bad. Would just as soon have the flu. It's been a month now and I still have these problems. Should not give people stuff like this.									N	11/27/2001	12/01/2001	4		OTH	UNK	NONE		Some minor allergies			1						1	Headache; Pharyngitis; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0179676	01/03/2002	CA	36.0	36		F	12/21/2001	Very sore in muscles in arm and shoulder and neck swollen, tight muscles, pain in joint (shoulder) upper arm, shoulder and neck ache.									U	12/20/2001	12/20/2001	0	NONE	PUB	PVT	Celexq and Robutussin CE	NONE	NONE			1						1	Oedema; Pain	FLU3~PFIZER\WYETH~4018049~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0179679	01/03/2002	KY	80.0	80		F	12/13/2001	Swelling and redness of left upper arm from deltoid to elbow next day.				Y					Y	11/28/2001	11/29/2001	1		PUB	PUB		NONE	NKDA			1						1	Erythema; Oedema	FLU3~PFIZER\WYETH~4018043~7+~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0946K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0179681	01/03/2002	KY	64.0	64		F	12/28/2001	Flu shot given 12/10/2001. Several days later, complained of pruritis and rash over entire body that continues today 12/28/2001, despite treatment with corticosteroids (topical and IM).				Y					N	12/10/2001	12/12/2001	2	NONE	PUB	PVT	Premarin and Accupril	NONE	Hypertension			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~UO701AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179682	01/03/2002	PA	62.0	62		F	12/10/2001	At approximately 10 PM 12/06/2001 had chills lasting about 3 hours then starting vomiting and vomited about every hour from 1 AM to 6 AM. Then got headache which lasted until noon when she took aspirin. She felt welt weak and washed out until Saturday evening.									Y	12/06/2001	12/06/2001	0		PUB	PUB	Claritan; Calcium; Estropipate	NONE	Asthmatic; Allergic to PCN and Chloromycetin; Environmental allergies		PA0163	1						1	Asthenia; Chills; Headache; Vomiting	FLU3~SANOFI PASTEUR~UO690AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179683	01/03/2002	IA	35.0	35		F	12/11/2001	Left arm broke out  in hives, weakness in arm, SOB, feeling faint. Received Epi-Pen at site of vaccine then transported to ER where she was prescribed methyprednisol and Claritin.				Y					Y	12/06/2001	12/06/2001	0	UNK	OTH	PVT	NONE	NONE	Denies	~Influenza (Seasonal) (no brand name)~~0.00~In Sibling		1						1	Asthenia; Dyspnoea; Syncope; Urticaria	FLU3~SANOFI PASTEUR~UO727AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179684	01/03/2002	IL	61.0	61		F	12/20/2001	Bumps on hands, arms. Redness on hands, arms, neck, face. Itching.				Y					Y	10/31/2001	11/01/2001	1		PUB	PUB			Breast Cancer			1						1	Erythema; Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0179685	01/03/2002	PA	45.0	45		F	12/19/2001	Left arm after injection had a stinging sensation, small lump and red on 12/13/2001. On 12/14/2001 left arm inflamed up to 7 cm round. Hot to touch. Remains red 5 cm, no pain on 12/19/2001.									Y	12/13/2001	12/13/2001	0	NONE	OTH	PUB		NONE	PCN Allergy			1						1	Injection site hypersensitivity; Injection site inflammation; Injection site mass	FLU3~PFIZER\WYETH~4018047~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0179688	01/04/2002	PA	68.0	68		F	12/28/2001	On November 8, pt had strange feeling in tongue, hard to talk. On November 9, had stroke, worse than the day before. Hospitalized, as of this date speech still affected. Also coordination in the right hand affected.alxo Dysarthria. Per 1 year follow up:  Pt has not recovered. I have been left with a speexh impediment. Also a weakness in my voice and unable to sing like before. I have difficulty writing.					Y	1			N	11/07/2001	11/09/2001	2		PUB	OTH	Synthroid; Imdur; Glucosamine; Glurvarica; Estratest; Aspirin; B-6; B-12; Folic Acid; Vitamin E	NONE	Allergy to penicillin; Diabetes; hypertention; coronary art dis; hypothyroid			1						1	Cerebrovascular accident; Dysarthria; Dysgraphia; Dysphonia; Hemiplegia; Speech disorder; Tongue disorder	FLU3~SANOFI PASTEUR~UZ679AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0179699	01/04/2002	CA	66.0	66		F	01/03/2001	Patient experienced weakness in left hand, with pain from the elbow to the wrist.				Y					Y	11/30/2001	11/30/2001	0		PVT	UNK	NONE	NONE	NONE			1						1	Muscular weakness; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0179700	01/04/2002	PA	51.0	51		F	12/21/2001	The pt developed extreme flu-like symptoms. Every muscle ached and couldn't move or get comfortable for 3 days. Fever with Tylenol was 101.5F, without ? Arm at sight of shot and the whole upper arm was swollen. Both shots were given in the same arm.									Y	11/01/2001	11/01/2001	0		OTH	OTH	HRT			Soreness, slight ache~Influenza (Seasonal) (no brand name)~~50.00~In Patient		1						1	Hypokinesia; Influenza like illness; Injection site swelling; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0179703	01/04/2002	MS	49.0	49		F	12/18/2001	The pt's arm swelled up and turned red. It was swollen from the shoulder to the middle of lower left arm (pneumonia shot). Took antibiotics.				Y					Y	11/01/2001	11/01/2001	0		PUB	OTH	NONE		Fibromyalgia; eczema; stress and anxiety disorder; can't sleep			1						1	Injection site erythema; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0179704	01/04/2002	AL	59.0	58		M	12/14/2001	12/10/2001-Onset of congestion and runny nose. No fever, no sore throat, no malaise, no muscle aches. The patient went to the doctor because they were very prone to bronchitis He was told that he had a cold and was prescribed Ampicillin. The patient is aware that the vaccination doesn't protect against URI. He just followed CDC's info on us (VAERS)				Y					Y	11/15/2001	12/10/2001	25		OTH	PUB	Atendol Glucotral	NONE	HTN diabetes		CA-01-0139	1						1	Pulmonary congestion; Rhinorrhoea	FLU3~SANOFI PASTEUR~U05922A~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179706	01/04/2002	FL	36.0	36		F	11/20/2001	11/18/2001-at 1600, three hours post-vaccination, the patient's eyes and lips began to swell. She took 50 mg of Benadryl p.o. at home and then  fell asleep. She awoke at 2000 with chest and throat tightness. At 2100, she went to the ER c/o wheezing and throat tightness. She received 2 doses of epinephrine, thirty minutes apart and 50 mg Benadryl IV				Y					Y	11/19/2001	11/19/2001	0	chest and throat x-ray	OTH	PUB	Paxil 20 mg daily	NONE	sulfa, codeine, percocet		FL01029	1						1	Chest discomfort; Eye oedema; Face oedema; Throat tightness	FLU3~SANOFI PASTEUR~U0681AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179707	01/04/2002	FL	56.0	56		F	12/12/2001	Patient experienced an itchy rash on her arms and legs, along with underarm soreness in the area of her lymph nodes.									Y	12/04/2001	12/09/2001	5		OTH	PVT		NONE	NONE			1						1	Myalgia; Rash	FLU3~SANOFI PASTEUR~U0675BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179708	01/04/2002	FL	50.0	50		F	12/12/2001	Patient experienced bright red rash on both legs									Y	12/04/2001	12/09/2001	5		OTH	PVT		NONE	Not specific; sensitive skin			1						1	Rash	FLU3~SANOFI PASTEUR~U0675BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179709	01/04/2002	FL	59.0	59		F	12/12/2001	Patient experienced a rash on left arm, a fever and soreness for a day and a half.									Y	11/30/2001	12/07/2001	7		OTH	PVT		NONE	NONE			1						1	Myalgia; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0179725	01/07/2002	WI	59.0	59		F	12/26/2001	As the nurse was giving me the shot, a severe pain went creeping down my arm. When it reached my hand, it felt like an explosion going off. I have had a very painful arm for the past six weeks. At first, I had to carry my arm around. It does seem to be getting better.				Y					U	11/13/2001	11/13/2001	0		PUB	PVT	NONE	NONE	NONE			1						1	Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0179726	01/07/2002	TX	34.0	33		F	01/04/2001	Patient c/o of a warm flush feeling, tight throat and dizziness. Pulse to 146. Treated  with two 25 mg Benadryl capsules									Y	01/03/2001	01/03/2001	0		UNK	UNK	Mesacort	NONE	Penicillin			1						1	Chest discomfort; Dizziness; Hot flush	FLU3~AVENTIS PASTEUR~U0712AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179727	01/07/2002	NJ	3.0	3		M	12/20/2001	Patient experienced a 101 degree F fever, loss of appetite, head cold type symptoms (congestion, excess mucous, cough. He was treated with expectorant, cough suppressant, decongestant, antihistamine, and eventually antibiotics for an ear infection.									Y	11/06/2001	11/06/2001	0		PVT	UNK	NONE	NONE	sensitivity to Phenebarbitol at birth			1						1	Cough; Nasal congestion; Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~U0694AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179728	01/07/2002	CA	75.0			F	12/27/2001	Patient experienced flu symptoms for a period of time lasting more than 36 hours. There was no fever. She was treated with aspirin and bed rest.									Y					UNK	OTH	Tamaoxifen, effexor	NONE				1						1	Influenza like illness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0179730	01/07/2002	CA	48.0	48		F	12/23/2001	11/11/2001-Seven weeks into her pregnancy, the patient had a spontaneous abortion.				Y					Y	11/06/2001	11/11/2001	5	Sonogram	PUB	UNK	Progestrone,Estrpgen, Folic Acid, ASA	URI	NONE			1						1	Abortion	FLU3~EVANS VACCINES~E73100LA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0179731	01/07/2002	NY	41.0	41		M	12/10/2001	On 12/07/2001, patient c/o dime-sized abrasion-like local reaction. He states it baecame red and itchy.									Y	12/06/2001	12/07/2001	1	NONE	OTH	UNK		NONE	Patient had molar extraction on the same day as the vaccination.			1						1	Erythema; Pruritus	FLU3~PFIZER\WYETH~4018024~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0179732	01/07/2002	AZ	71.0	71		M	12/27/2001	Patient received the pneumococcal vaccine on 12/26/2001. They then experienced erythemia and warmth on the upper part (shoulder to elbow) of the arm which the vaccine was administered.										12/26/2001	12/27/2001	1		PUB	PUB			KNA			1						1	Feeling hot; Injection site erythema	FLU3~PFIZER\WYETH~401A028~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~475951~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0179735	01/07/2002	AZ	57.0	57		F	12/14/2001	10/24/01-Patient experienced tremors which were more severe on the right side of his body. He also had a headache and his eyes were involuntary cross-eyed.  10/26/2001-The neurologist did a lumbar puncture and a WBC. (See results below) 10/27/01- All symptoms were resolved.				Y					Y	10/16/2001	10/24/2001	8	LP-fluid clear, no blood, 88% lymph, WBC-increased	PVT	PUB			EES, Naproxen,Verapamic, Corimoxazole; SLE; MVP; Diabetes; HTN			1						1	Headache; Strabismus; Tremor; White blood cell count increased	FLU3~SANOFI PASTEUR~110573AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0109197	01/08/2002	NY	45.0	45		M	01/04/2002	A 45 year old male pharmacist reported that he received Flu-Shield (1997-1998) on 10/24/97. Within 15 minutes, post vax, he developed welts and itching on his chest and upper extremities. He was immediately seen by a Dermatologist who administered epinephrine and an inhaler (unspecified). He was also treated with prednisone and an inhaler (unspecified). The symptoms lasted about 3 weeks. The reporter noted that he has received flu shots virtually every year since 1975 and this was the 1st time he developed a reaction. This case was considered serious since hypersensitivity that required treatment with epinephrine was considered to be Other Important Medical Events in this case. No additional information was available as of the date of this report. Follow-up information received on 12/28/01 states that the pt was treated by a dermatologist who administered epinephrine, prednisone and albuterol inhaler. According to the dermatologist, the pt also developed rash, neuralgia, dyspnea, difficulty in sleeping and pain. The symptoms lasted for 4 weeks and the pt recovered.				Y					Y	10/24/1997	10/24/1997	0	UNK	OTH	PUB	NONE	NONE	Allergy to animals; drug hypersensitivity; food allergy		HQ8056506NOV2001	1						2	Dyspnoea; Insomnia; Neuralgia; Pain; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4978184~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0176999	01/08/2002	KS	64.0	64		M	01/03/2002	It was reported that a 64 year old male pt received a Fluzone SV '01-'02 vaccination administered IM in his arm on 9/24/01 between 12:55-13:00. At approx. 13:15, that same day, the pt became disoriented and was unable to drive. The pt went to the doctor's office within a few days and was dx'd with an ear infection (left side). The ear infection continued to worsen and the pt was hospitalized on 10/12/01. Tests ran had a cranial nerve infection, Bell's Palsy. Spinal tap is pending. The pt is home as of this date, 12/28/01. The pt is scheduled to see his doctor next week to discuss options.				Y	Y				U	09/24/2001	09/24/2001	0	Spinal tap-pending; MRI-showed cranial nerve infection, Bell's Palsy; Blood tests-results not provided	PUB	PVT		NONE	High blood pressure; hiatal hernia; asthma		U2002000020	1						2	Cranial nerve disorder; Disorientation; Ear disorder; Facial palsy; Infection	FLU3~SANOFI PASTEUR~U0574AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0177315	01/08/2002		62.0	62		M	01/03/2002	Information has been received from a pharmacist and an LPN concerning a 62 year old white male with a single kidney who on 10/30/01 was vaccinated with pneumococcal vaccine 23 polyvalent (lot 636849/0944K) in the right deltoid along with the influenza virus vaccine in the left deltoid. A few hours, post vax, the pt phoned the physician's office and complained of the right deltoid shot area being red, swollen and painful. The pt was instructed to take diphenhydramine hydrochloride (Benadryl), 50mg, take an unspecified anti-inflammatory and to put ice of the area and to follow-up PRN. The pt returned to the physician's office on 10/31/01 where his whole arm was red, swollen and painful. The pt was treated with methylprednisolone sodium succinate (Solu-Medrol) 125mg and was prescribed prednisone 20mg, BID X 1 day then 20mg, daily X 1 day. He was instructed to take ibuprofen 600mg TID, Benadryl 25mg q 6 hours PRN, apply cold packs and to call if not markedly improved or resolved. The pt went to the ER (no further details provided). The LPN considered the swelling, redness and pain to be disabling and an Other Important Medical Event. The pharmacist reported on another pt (WAES01110021). Additional information is not expected.				Y				Y	U	10/30/2001	10/30/2001	0		OTH	OTH	Lasix 40mg (furosemide); potassium (unspecified)		Single kidney		WAES01110662	1						2	Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0944K~UNK~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Disabling	Influenza
0179744	01/08/2002	NY	50.0	50		M	01/06/2002	The pt developed severe fever, chills 3 weeks after vaccines followed by neuritis and peripheral neuropathy in left arm and paralysis of left thumb and index finger. Annual follow up states patient's strength in thumb and index finger at about 50%. Continued pain in forearm and muscle loss near wrist.				Y				Y	N	10/27/2001	11/19/2001	23		OTH	PVT		sinus condition				1						1	Neuropathy peripheral; Pain; Paralysis; Pyrexia	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0179761	01/08/2002	AL	23.0	23		F	12/27/2001	Approx. 10-15 minutes, post vax, the pt complained of itching all over her body. Her left ear was read. Treated with Epinephrine 0.3cc, SC, followed with Benadryl 50mg. Her BP was 118/72. After 5 minutes, the pt states itching was less but weak. Referred to MD. Taken per employer.				Y					Y	12/12/2001	12/12/2001	0		OTH	PUB		NONE	NONE		AL0118	1						1	Erythema; Pruritus	FLU3~SANOFI PASTEUR~U0279AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179764	01/08/2002	NV	34.0	34		F	12/18/2001	The pt became pale and diaphoretic. BP 160/100; HR 128 and Resp 32. She was shaky, nauseated. Dextrostix-32. She was unable to keep blood sugar up X 12 hours. Treated with 50% Dextrose X 3 over the next 3 hours and 3L D5W. Returned to normal after 18 hours. She is not diabetic or hypoglycemic.				Y					Y	12/14/2001	12/14/2001	0	CBC; UA; Dextrostix-32; BP-160/100; HR-128; Resp-32	OTH	PUB	Celexa; Flexeril; Trazadone; Allegra D	Chronic Depression	Chronic Depression; Allergic to sage			1						1	Blood glucose decreased; Blood pressure increased; Heart rate increased; Hyperhidrosis; Nausea; Pallor; Respiratory rate increased; Tremor	FLU3~SANOFI PASTEUR~U0571AD~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179767	01/08/2002	VA	48.0	48		F	01/03/2002	Received vaccine on 12/20/2001 at 4:30 PM. On 12/21/2001 arm swollen and painful. Developed urticaria which lasted about 10 days.									Y	12/20/2001	12/21/2001	1		PUB	PVT	Zyrtec	NONE	History of urticaria, cause unknown.			1						1	Oedema; Pain; Urticaria	FLU3~PFIZER\WYETH~4018054~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0179768	01/08/2002	NJ	52.0	52		F	11/13/2001	Symptoms started 11/07/2001 with fatigue, malaise. On 11/08/2001 joint aches, stiff neck and lower back ache. Will contact PMD 11/13/2001 regarding symptoms which she is currently experiencing.									Y	11/02/2001	11/07/2001	5	NONE	PUB	PUB	Zoloft 100 mg OD Daily ASAT OD	NONE	History of Lyme disease 5 or 6 years ago or greater.			1						1	Arthralgia; Back pain; Fatigue; Malaise; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~UO597AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179770	01/08/2002	NY	73.0	72		M	12/20/2001	The patient experienced a local reaction in his left deltoid region. (erythema, edema and tenderness to palpitation.									Y	12/17/2001	12/18/2001	1	NONE	PVT	PVT		Local soft tissue reaction	cardiac valvalopathy			1						1	Erythema; Myalgia; Oedema	FLUX~UNKNOWN MANUFACTURER~E12451M~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1171L~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0179772	01/08/2002	VA	50.0			M		The patient received the vaccine around 1430 on Thursday. He felt lethargic that evening. On Friday, he experienced chills, followed by mild fever about a hour later. Later in the day, a coworker noticed that the patient's face was red and spotty. The patient took Benadryl and Tylenol. The fever was gone by 2100. He was still lethargic on Saturday. He was fine by Sunday									Y					PVT	OTH			allergic to Penicillin			1						1	Erythema; Lethargy; Pyrexia	FLU3~SANOFI PASTEUR~U0699AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179773	01/08/2002	NY	76.0	76		F	01/04/2002	Patient c/o of a very sore arm, with a LOM. She has improved slightly.									U	12/03/2001	12/03/2001	0		PUB	PUB						1						1	Hypokinesia; Myalgia	FLU3~SANOFI PASTEUR~U0687DA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179774	01/09/2002					U	12/18/2001	Based upon a report received from a health care professional, a patient was inadvertently given Flushield vaccine with a TB syringe and subsequently developed a red mark the size of a coffee cup at the injection site.									U					OTH	OTH					0116800121	1						1	Injection site erythema	FLU3~PFIZER\WYETH~4018028~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0179777	01/09/2002		58.0	58		F	12/27/2001	The pt received a flu vaccine on 11/5/99 without incidence. On 10/18/01 or 10/19/01, the pt received a Fluvirin vaccine on her deltoid muscle. Within 48 hours, 10/20/01, the pt was dx'd with a cerebral thrombosis and was admitted to a hospital. The pt experienced cerebral thrombosis, MCA with right hemiparesis and aneurysm on the left carotid artery. The pt was discharged on 10/29/01 and at the time of the report was undergoing rehabilitation therapy. The reporter has stated that the pt's family doctor believed that there was a possible relationship with Fluvirin. The pt did not have a risk factor for stroke per her family physician. The left carotid aneurysm found on exam was a risk factor already present, although unknown. Also, the concomitant use of Premarin would have increased the pt's risk of cardiovascular events. It is more likely that the combination of the aneurysm and the use of Premarin resulted in this event rather than the vaccination with Fluvirin. Further information regarding the other risk factors will be requested from the reporter.					Y				Y	10/18/2001	10/20/2001	2		OTH	OTH	Premarin; Flonase; Claritin		Hysterectomy 1998; osteoarthritis of right knee; menopause; glaucoma within the last year		PJP2002000010	1						1	Aneurysm; Carotid artery thrombosis; Hemiparesis	FLU3~EVANS VACCINES~E06731KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0179785	01/09/2002	MS	57.0	57		F	12/14/2001	Breast cancer diagnosed 3/2000. Multiple joint pain, stiffness and insomnia.			Y	Y	Y	5			N	11/07/1999				MIL	OTH	Premarin; Provera; Clonidine	NONE				1						1	Arthralgia; Breast cancer; Insomnia; Joint stiffness	ANTH~MICHIGAN DEPT PUB HLTH~FAV043~1~~LA~ANTHRAX (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4998235~3~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0179797	01/09/2002	OK	27.0	27		F	10/23/2001	Approx. 4 hours, post vax, a rash started and the pt complained of nausea and vomiting, severe headache and swelling in the right arm and breast. Her right jaw became very sore, stiff and tingling began in fingers of right hand. Injection site was hard, swollen and had dark bruising. It was painful to touch. She took Benadryl with only small improvement. Ice pack was used to the injection site. Is starting to feel better.				Y					Y	10/22/2001	10/22/2001	0		PVT	OTH		NIDDM	NIDDM		OK0156	1						1	Contusion; Headache; Hypertrophy breast; Injection site induration; Injection site pain; Injection site swelling; Nausea; Pain in jaw; Paraesthesia; Vomiting	FLU3~SANOFI PASTEUR~U0668AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179799	01/09/2002	MN	23.0	23		F	11/01/2001	Patient received the flu vaccine on 10/31/2001. That evening, she experienced a fever and a  sore arm. The sore throat, which the patient had prior to the vaccination, became more swollen. By the next day, the arm where the injection was given had developed a swollen, hard , itchy knot. The day of this report, 11/01/2001, the site is hot to touch, itchy, sore, swollen, and the size of a golf ball.				Y					Y	10/30/2001	10/30/2001	0		PUB	PUB	NO	Sore throat	NONE		MN01003	1						1	Feeling hot; Injection site induration; Injection site swelling; Myalgia; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~U0671BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179800	01/09/2002	FL	80.0	80		M	12/21/2001	approximately thee days post vaccination, the patient experienced dizziness, fatigue, fever, sore throat,stuffy head ans some coughing. these symptoms lasted three to four days.				Y					Y	11/06/2001	11/09/2001	3		PUB	PUB	synthroids tabs	NO	Penicillin			1						1	Cough; Dizziness; Fatigue; Nasal congestion; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U681AA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179804	01/09/2002	GA	42.0	42		F	01/08/2002	Hives (generalized) on day 4 - treated with Benadryl and Dimatap.  On 12/28/2000, right leg became hot and achy.  Following day spasms in hands and leg began and some pain.  Saw MD on 01/07-diagnosed with Myalgia from allergic reaction.  Treatment with Percocet with very little relief.  Neurology consult suggested.				Y					U	12/21/2000	12/25/2000	4	None done	UNK	PVT	Folic acid; BVL	No	Refractory megablastic anemia			1						1	Feeling hot; Muscle spasms; Myalgia; Pain; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0179805	01/09/2002	MT	1.25	1	.3	M	12/29/2001	On 12/29/2001, patient experienced a febrile seizure at 0100.				Y					Y	12/28/2001	12/29/2001	1	NONE	PVT	UNK		NONE	Previous febrile seizure X2			1						1	Convulsion	DTAP~SANOFI PASTEUR~U05360B~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~40715AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~CONNAUGHT LABORATORIES~UA637AA~3~IM~RL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~T1153~3~SC~LL~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0734L~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~483164~2~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0179806	01/09/2002	IA	14.0	14		F	01/01/2002	Following the injection (the next day), the patient broke out in hives and was itchy for about 2 1/2 -3 days. I gave her Benadryl to relieve the symptoms. She was not seen by the doctor. the hives went away after about 3 days.									Y	11/16/2001	11/17/2001	1	NONE	PVT	PVT	NONE	NONE	Diagnosed with ADHD, but not on medication. Allergies-codeine,ephedrines, cats, some trees Healed patent ductus arteriosus			1						1	Urticaria	FLU3~SANOFI PASTEUR~U0602BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179807	01/09/2002	PA	81.0	81		F	01/03/2002	PATIENT STATES: Nasal dryness,hoarseness, fatigue, colorless urine									Y	10/13/2001	10/13/2001	0		PVT	PVT	Atenolol, alprazolam, dyazide	Mild, viral-type URI	HTN, Rheumatoid Arthritis, Osteoporosis, COPD			1						1	Dysphonia; Fatigue; Nasal dryness; Urine analysis abnormal; Cough; Decreased appetite; Insomnia; Laryngitis; Pharyngitis; Rhinitis; Weight decreased; Cough; Laryngitis; Oral intake reduced; Sleep disorder; Weight decreased	FLU3~SANOFI PASTEUR~U0681AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~00681AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~U0681AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA		Influenza
0179812	01/09/2002	WI	46.0	46		F	12/21/2001	The pt developed myalgia, arthralgia, headache, photophobia, fever, local swelling, local erythema and chills, post vax.				Y					U	12/19/2001	12/19/2001	0		OTH	OTH		NONE	Allergy to erythromycin; arthritis			1						1	Arthralgia; Headache; Injection site erythema; Injection site swelling; Myalgia; Photophobia; Pyrexia	FLU3~EVANS VACCINES~E05211KA~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1052L~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0179813	01/09/2002	CA	51.0	51		F	01/02/2002	I woke up in the middle of the night itching with hives all over my body, on 11-22-01 went to my own family doctor on 11-22-01. Said he didn't know what caused the hives.				Y					Y	11/06/2001	11/22/2001	16		OTH	PVT	Estratest					1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0179842	01/10/2002		59.0			M		A 59 year old male pt experienced severe abdominal pain and pancreatitis, which resulted in prolonged hospitalization one day after receiving the Fluvirin vaccine on 08-OCT-2001. At the time of reporting the pt was recovering. There was insufficient information to determine the reporter's causality assessment.					Y				U	10/08/2001	10/09/2001	1		OTH	OTH	Meloxicam; Rantidine	NONE	Gout and osteoarthritis		PJP2002000110	1						1	Abdominal pain; Pancreatitis	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0179844	01/10/2002	TX	66.0	66		M	01/08/2002	Post vax, the next morning (12/16/01) the pt had a cramp in left shoulder with pain. He had flu-like symptoms and left extremity pain on 12/20/01. Leg were weak and had difficulty walking. On 12/23/01, his legs gave out and he fell to the ground. Went to ER and evaluated by MD who conducted nerve conduction velocity: finding consistent with Guillain-Barre Syndrome. He was started on IVIG on 12/23/01 and also on 12/24/01, 12/25/01 and 12/26/01. The pt was not improving so he was transferred to another facility on 12/27/01. On 1/2/02, dx'd with GBS; not moving anything at all but can open eyes. He will be on prolonged ventilation support.					Y			Y	N	12/15/2001	12/16/2001	1		OTH	PUB		NONE			TX02006	1						1	Asthenia; Difficulty in walking; Guillain-Barre syndrome; Muscle spasms	FLU3~SANOFI PASTEUR~UO698AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0179845	01/10/2002		73.0			M		A 73 year old male experienced polymyalgia rheumatica, which resulted in persistent or significant disability or incapacity, 5 days after receiving the Fluvirin vaccine on 05-OCT-2001. He was treated with oral steroids. The pt had not recovered at the time of reporting. There was insufficient information to determine the reporter's causality assessment.								Y	U	10/05/2001	10/10/2001	5	C-reactive protein-95mg/l	OTH	OTH	Voltarol; lisinopril				PJP2002000090	1						1	Laboratory test abnormal; Polymyalgia rheumatica	FLU3~EVANS VACCINES~760525~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0179848	01/10/2002	IL	52.0	52		M	01/03/2002	On November 20, 2001, this employee received the flu vaccine. On December 19, 2001 he was diagnosed with GBS. He was hopsitalized for one week and is recuperating at home. His completed recovery may take three months.			Y	Y	Y	8			Y	11/20/2001	12/19/2001	29		PVT	PVT		NONE	Diabetes, PCN and sulfa (allergies) and epilepsy.			1						1	Guillain-Barre syndrome; Guillain-Barre syndrome	FLU3~SANOFI PASTEUR~UO671BA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0671BA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0179858	01/10/2002	NC	74.0	74		F	12/26/2001	Three days after flu vaccine administration, developed cellulitis, inflammation at injection site adverse reaction.				Y					U	12/19/2001	12/21/2001	2		PVT	PVT	Hyzaar 125/50 T PO OD	NONE	Hypertension			1						1	Cellulitis; Injection site inflammation	FLU3~SANOFI PASTEUR~UO729AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179859	01/10/2002	CA	67.0	67		F	12/31/2001	Pt seen in our office on 12/28/2001. Stated she received flu vaccine 10 prior. Diagnosed with herpes zoster. Treated with Acyclovir, prednisone and Vicodin.										12/14/2001	12/28/2001	14		PUB	UNK	UNK	UNK	UNK			1						1	Herpes zoster	FLU3~SANOFI PASTEUR~UO705AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179870	01/11/2002	NJ	29.0	29		M	12/10/2001	I have had a reoccurring rash for two weeks. It started two days after my flu shot. I've also had chest pains every few days.				Y						11/26/2001	11/26/2001	0		MIL	MIL	Tubersol					1						1	Chest pain; Rash	FLU3~SANOFI PASTEUR~U0674AA~5~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179871	01/11/2002	CA	75.0	75		F	12/27/2001	Immediately after injection, redness appeared and proceeded to get redder As the day wore on until it was down to the elbow by 3 pm and slightly raised . Redness lasted one week.				Y					Y	10/19/2001	10/19/2001	0	NONE	PVT	UNK	B12;Lopressor;Norvasc;clonidine;asprin		Hypertension;low thyroid; high cholestrol			1						1	Rash erythematous	FLU3~SANOFI PASTEUR~U0680AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179874	01/11/2002	NY	52.0	52		M	01/04/2002	12/31/2001-Received vaccine 01/01/2002-developed red spot than red rash on inner thigh which spread upward to trunk /01/02/2002 hands swollen, lower lips swollen, no breathing problems. took Benadryl po. saw M.D. 01/02/2002-No cause of reaction determined, told to not get flu & pneumonia vaccines again.				Y					Y	12/31/2001	01/01/2002	1		PUB	PUB	NONE	NONE per patient	PCN			1						1	Erythema; Face oedema; Oedema peripheral; Rash	FLU3~SANOFI PASTEUR~U0690AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0996L~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0179876	01/11/2002		55.0			F		An ASPP (Anonymised Single Patient Print) was received from the MCA (regulatory authority) on 01/03/2002, concerning a 55 year old female patient who experienced bronchopneumonia, 2 days after receiving the Fluvirin vaccine on 10/15/2001.  The receiving was receiving diclofenac concomitantly. The patient has no other medical problems, no allergies and no previous drug reactions.   On 10/15/2001, the patient received the Fluvirin vaccine. On 10/17/2001, the patient experienced bronchopneumonia. She was treated with steroids and antibiotics. The patient recovered on 11/30/2001 after treatment.   there was insufficient information to determine the reporter's casualty assessment.														UNK	UNK	Diclofenac		The patient has no other medical problems, no allergies and no previous drug reactions.		PJP200200014	1						1	Pneumonia	FLU3~MEDEVA PHARMA, LTD.~760659~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0179877	01/11/2002		51.0			M		A report was received on 02-JAN-2002 from concerning a 51 year old male pt who was hospitalized for chest pain after receiving Fluvirin vaccine on 11-DEC-2001.					Y				U	12/11/2001	12/11/2001	0		UNK	UNK					PJP2002000080	1						1	Chest pain	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0179927	01/14/2002	SC	64.0	64		M	12/15/2000	The pt received influenza vaccine during AM hours. The pt seemed fine for several hours but was found unresponsive by a neighbor that afternoon. Resuscitation efforts failed and the pt was pronounced dead at 17:52 on 11/14/00. Her death was felt to be sudden cardiac death with a history of diabetes and hypertension. Please not the date of the event, 11/14/01, is the correct date. The pt died on the same day he received influenza immunization.	Y	11/14/2000		Y					N	11/14/2000	11/14/2000	0		PUB	UNK		NONE	PCN allergy; history of diabetes and hypertension.		SC00094	1						1	Cardiac arrest; Coma	FLU3~MEDEVA PHARMA, LTD.~E66350NA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0179940	01/14/2002	NJ	37.0	37		F	12/14/2001	The pt developed an erythematous, maculopapular rash all over her body, including her palms and soles of her feet. It was also pruritic. Treated it with cetirizine and it resolved.									Y	10/26/2001	11/01/2001	6	NONE	PVT	PVT		NONE				1						1	Erythema; Pruritus; Rash maculo-papular	FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~U0516AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0179941	01/14/2002	MI	44.0	44		F	01/08/2002	Area of injection site became red, inflammed, hard/firm, warm to touch and slightly sore. The area of induration and erythema measured approx. 3 across. Seen in a walk-in clinic by ER physician. Treatment: Benadryl.				Y					Y	12/17/2001	12/17/2001	0		PUB	OTH	NONE	NONE	Allergies to codeine, iodine, Cipro, weeds, grass and trees.			1						1	Injection site erythema; Injection site induration; Injection site inflammation; Injection site pain; Injection site warmth	FLU3~PFIZER\WYETH~4018044~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0179942	01/14/2002	TX	6.0	6		M	01/03/2002	The pt received his 1st flu shot on 12/20/01. That PM, he had a fever to 102F and a febrile seizure. The next day, he continued to have a fever plus a headache, stiff neck and vomiting. He also had neck pain and chills. At the ER, the doctor gave him an antibiotic shot and told us he did not have meningitis since his WBC was over twice the normal amount.				Y					Y	12/20/2001	12/20/2001	0	WBC-25; CSF-neg with only 3 WBC	PVT	PVT	Claritin Reditabs; Nasahist AQ	Allergic rhinitis	Febrile seizure; allergic rhinitis; EIA			1						1	Chills; Febrile convulsion; Headache; Musculoskeletal stiffness; Neck pain; Vomiting; White blood cell count increased	FLU3~SANOFI PASTEUR~U0717AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179943	01/14/2002	CA	60.0	60		F	01/07/2002	Pain in left arm, heaviness in chest, weakness, discomfort in abdomen, loss of appetite, sleeplessness, restless, sporadic trembling and shivering.				Y					N	11/27/2001	11/30/2001	3	CXR; Heart Scan; CT Scan; Ultrasound of abdomen; GI Series. All tests were normal.	PVT	PVT	Prempro	NONE	NONE			1						1	Abdominal discomfort; Anorexia; Asthenia; Chest pain; Chills; Insomnia; Pain; Restlessness; Tremor	FLU3~SANOFI PASTEUR~U0695AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179944	01/14/2002	IN	20.0	20		F		On 12/3/01, post vax, had nausea and vomited X 2. She had left arm pain from 12/3/01 through 12/6/01. On 12/5/01, she had severe left arm pain with egg-sized lymph nodes on left neck and shoulder. Also had a fever of 100.3F. She went to ER. Pt is on Keflex and Vicodin.				Y					U	12/03/2001	12/03/2001	0	CBC	PVT	PVT			Erythromycin and Bactrim allergy; avoids nuts; has endometriosis			1						1	Lymphadenopathy; Nausea; Pain; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~4018053~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0179945	01/14/2002	NJ	47.0	47		F	12/14/2001	The pt developed a rash, 2 days post vax. It was erythematous, maculopapular and pruritic. It resolved with diphenhydramine.									Y	10/29/2001	10/31/2001	2	NONE	PVT	PVT			NONE			1						1	Erythema; Pruritus; Rash maculo-papular	FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179946	01/14/2002	NY	10.0	10		F	12/28/2001	Severe local reaction with warmth, erythema, pain and a scar.									Y	11/21/2001	11/21/2001	0	NONE	PUB	PUB		NONE	NONE			1						1	Injection site erythema; Injection site pain; Injection site warmth; Scar	FLU3~PFIZER\WYETH~4018023~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0179947	01/14/2002	GA	56.0	56		F		3 days, post vax, the pt developed pain and weakness in left shoulder.									U	12/04/2001	12/07/2001	3		OTH	PUB	Estrogen; Estotest; Wellbutrin; Serzone	NONE	Scoliosis; depression; menopause; Herniated nucleus pulposus L-spine			1						1	Muscular weakness; Pain	FLU3~SANOFI PASTEUR~U0708AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179948	01/14/2002	WA	65.0	65		M		The pt's left arm experienced sensitivity after flu shot was administered and have received 2-3 months of physical therapy and has still not regained all sensitivity. The doctor felt a nerve or tendon was hit.								Y	U	10/26/2001	10/26/2001	0		OTH	OTH						1						1	Sensory disturbance	FLU3~SANOFI PASTEUR~U0681AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0179974	01/15/2002	TX	49.0	49		M	12/26/2001	The pt had chills, fever (103F) and 5 diameter of redness around the injection site.					Y	3			Y	11/28/2001	11/29/2001	1		PUB	PUB		NONE	ASCVD; CAD; elevated cholesterol			1						1	Injection site erythema; Pyrexia	FLU3~SANOFI PASTEUR~U0689AA~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1043L~UNK~SC~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0179981	01/15/2002	WA	42.0	42		M	12/03/2001	The pt received Flu shot in the left arm at work on 11/16/01. On 11/23/01, the pt had weakness of LUE and could not lift arm above shoulder. He had occasional pain in left shoulder. Will refer to neurologist. Pt was evaluated for ? nerve problems.				Y					N	11/16/2001	11/23/2001	7		OTH	OTH					WA011808	1						1	Hypokinesia; Muscular weakness; Neuropathy; Pain	FLU3~SANOFI PASTEUR~U0688AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179982	01/15/2002	WA	70.0	70		F	12/12/2001	On 12/7/01, erythema with tenderness about 3-4 hours, post vax. Edema, erythema and tenderness continued the next day. Her husband came after pt and I checked affected area. There was firmness, edema, erythema and painful upon observance. Instructed to rest, elevate, use cold compress to area and seek medical care if conditions increase after 24 hours. Treated with anti-inflammatory RX. Telephone call to pt on 12/10/01 at 08:30 and pt completely recovered.									Y	12/06/2001	12/06/2001	0	NONE	PUB	PUB	Premarin	NONE	NONE		WA011812	1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling	FLU3~PFIZER\WYETH~4018054~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0994L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0179983	01/15/2002	WA	68.0	68		F	11/08/2001	I had a flu shot and pneumonia shot. I swelled up to past my elbow. It was painful and red.				Y					U	11/06/2001	11/07/2001	1		PUB	UNK		NONE	High blood pressure; Sjogren's Syndrome		WA011809	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~PFIZER\WYETH~4018027~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1449K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0179987	01/15/2002	VA	27.0	27		F	12/20/2001	Nausea and vomiting, pain and swelling on injection site with itching.									U	11/27/2001	11/27/2001	0		MIL	MIL						1						1	Injection site pain; Injection site swelling; Nausea; Pruritus; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0179988	01/15/2002	NY	44.0	43		F	01/08/2002	Swelling of leg, feet, ankle, wrists, hands and fever on 11/14/01. Had Fluzone  on 11/13/01. Seen in ER on 11/15/01.				Y					Y	11/13/2001	11/14/2001	1	WBC-11.6	PVT	UNK	Coloca; Soma; estradiol; Darvocet-N 100; Promotrun		Vaginal bleeding; chronic back pain; anemia secondary to menorrhagia; depression			1						1	Oedema peripheral; Pyrexia; White blood cell count increased	FLU3~SANOFI PASTEUR~U0711AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0179990	01/15/2002	PA	57.0	57		F	01/09/2002	Left brachial plexus neuropathy (mostly sensory) with pain and numbness starting 2 days, post vax; weakness secondary to pain. Symptoms from left trapezius muscle to fingers. Improving. Referred to a neurologist who started Neurontin.				Y					N	10/23/2001	10/25/2001	2	EMG-no correlation; Cervical MRI-Disc bulging at C5, C6, C7 no cord compression.	PVT	UNK	Xanax; Prozac; durovan; actos; HCTZ; ASA; Norvasc; Claritin; Ca++; MVI	Routine care	DM II; HTN; Factor V (heterozygosis)			1						1	Cartilage development disorder; Hypoaesthesia; Muscular weakness; Neuralgia; Neuropathy	FLU3~SANOFI PASTEUR~U0668AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0801L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0179991	01/15/2002	MI	66.0	66		F	12/05/2001	The pt received a pneumonia shot at 11:00 on 11/30/01 in RD. By 14:00, her right arm started to swell from my shoulder to elbow and was red and painful. Continued throughout the weekend. Swelling and pain decreased on 12/3/01. She saw her doctor on 12/3/01. No treatment was recommended. No more pneumonia shots.									Y	11/30/2001	11/30/2001	0		PUB	PUB		NONE	NONE		MI2001102	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U0700AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0944K~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0179993	01/15/2002	OK	57.0	57		F	01/10/2002	Began having soreness in left upper arm approx. 2 hours, post vax. By 18:00, the pain was worse and noted swelling of the arm. It also felt hot to touch. Now is experiencing itching which started at noon today.									Y	01/09/2002	01/09/2002	0	CBC-Slightly elevated WBC at 12,600	PUB	OTH	Timoptic; timolol .5% optic; latanoprost optic solution	NONE	Glaucoma			1						1	Injection site pain; Injection site swelling; Injection site warmth; Pruritus; White blood cell count increased; Injection site hypersensitivity; Injection site oedema; Injection site pain; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U0699AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1076K~2~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U0699AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1076K~2~IM~LA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0179995	01/15/2002	NY	54.0	54		F		Pt was sick for 3 days. Pt experienced body ache and drugged feeling. 12/24/2001: As of today the pt is feeling well. This is the first time she had received the flu vaccine.									Y	11/09/2001			NONE	PVT	PVT		NONE				1						1	Malaise; Pain	FLU3~SANOFI PASTEUR~UO691AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0176787	01/16/2002	IN	47.0	46		F	01/08/2002	Day after receiving flu shot, had knot under arm that went away. Developed a knot at injection site a few days later that also disappeared. As of 08/06/2001, shoulder pain with movement, recovered from left hip/side pain, but ankles swell,									U	01/22/2001	01/23/2001	1	MRI Blood tests after patient report	PUB	PVT	UNK	UNK	UNK			1						2	Oedema peripheral; Pain; Carpal tunnel syndrome; Injection site inflammation; Musculoskeletal stiffness; Nerve injury; Paraesthesia; Skin nodule	FLU3~PFIZER\WYETH~4008196~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|FLU3~PFIZER\WYETH~4008196~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~3	USA		Influenza
0180027	01/16/2002	OH	74.0	74		F	01/08/2002	Acute Guillian-Barre syndrome. Symptoms: numbness of hands and feet. Onset approximately 12/06/2001. Neurologist attributed to vaccine reaction. Treatment: 6 plasmapheresis treatments.					Y	13			Y	11/20/2001	12/06/2001	16	CT; MRI; Nerve conduction test	PVT	PVT	HydroDiuril; Cenestin; lansoprazole		Hypertension			1						1	Guillain-Barre syndrome; Hypoaesthesia	FLU3~PFIZER\WYETH~4018038~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0180065	01/16/2002		27.0	27		F	11/13/2001	Less than 24 hours, post vax, had onset of painful aphthous oral ulcerations; punctuate, shallow erosions on inferior/lateral tongue (Seen on day #3 of symptoms). Similar reactions reported with 2 previous flu shots. (Wyatt Flu shot-lot 4008209 at age of 26 and Connaught Flu shot-lot U0135AA at the age of 25)				Y					Y	11/09/2001	11/10/2001	1	Viral CX (HSV)-neg; ESR-5; ANA-neg; RF-neg; HSV IgM-neg	MIL	MIL	Ortho 777	NONE	NONE	Painful oral ulcers~Influenza (Seasonal) (FluShield)~~26.00~In Patient		1						1	Aphthous stomatitis; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U0686AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0180066	01/16/2002	SC	52.0	52		F	12/07/2001	The pt complained of throat feels like it's closing in and of tongue thick, skin warm/dry, RR 20, HR 88, BP 137/64. Also, complained of itching/burning at site. It was slightly edematous. Ice applied and Benadryl 25mg po given.									Y	12/07/2001	12/07/2001	0		PUB	OTH	UNK	NONE	UNK			1						1	Injection site pain; Injection site reaction; Injection site swelling; Pruritus; Throat tightness; Tongue disorder	FLU3~PFIZER\WYETH~4018037~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0180067	01/16/2002	CA	82.0	82		M	12/28/2001	Both groins had sharp pain on 11/12/01, mostly gone in 3 hours. Visited doctor on 11/13/01. No other problems. Suspected shot reaction. On 11/13/01 at 17:30, both shoulders very sore; left arm at injection site, was stiff and couldn't move. It was gone in about 5 hours.				Y					Y	11/09/2001	11/13/2001	4	NONE	OTH	OTH		NONE	Quadruple Bypass 10/01			1						1	Groin pain; Hypokinesia; Musculoskeletal stiffness; Pain	FLU3~SANOFI PASTEUR~V0592AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0180068	01/16/2002	GA	32.0	32		F	01/10/2002	Pneumonia injection given in left deltoid and arm was swollen, red and streaked.									Y	01/08/2002	01/08/2002	0		PVT	OTH	Sulfa medication	Bronchitis				1						1	Injection site erythema; Injection site swelling; Skin striae	FLU3~SANOFI PASTEUR~U0669AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1067K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0180069	01/16/2002	NM	4.0	4		M	01/08/2002	Pruritic, maculopapular, generalized rash noted 4 days, post vax. Fever occurred on day 9.									Y	12/27/2001	12/31/2001	4		PVT	PUB	NONE	NONE	Mild asthma			1						1	Pruritus; Pyrexia; Rash maculo-papular	FLU3~SANOFI PASTEUR~U0711AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~T1128~4~IM~LL~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0584~2~IM~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0180070	01/16/2002	MD	51.0	51		F	12/20/2001	Reported 12/28/01, a bruise 2 X 2. The center of the bruise, on the left arm where needle was inserted, blanched area about the size of a pencil eraser. It is very tender to touch but gradually improving. Did not seek medical attention. No treatment.									Y	12/14/2001	12/16/2001	2		OTH	PUB	ASA 325mg q/day; Prednisone 5mg q d; Plaquenil; Zial 2.5mg q/day	NONE	Rheumatoid Arthritis			1						1	Contusion; Injection site discolouration; Injection site pain	FLU3~PFIZER\WYETH~4018029~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0180071	01/16/2002	MA	42.0	41		F	01/08/2002	The pt experienced pain in her shoulder beginning 1 to 2 hours, post vax. The pt has had continuing discomfort with difficulty in raising arm, lifting, etc. Presently, she is under the care of a physician. She takes ibuprofen 800mg 4 x/day, stretching, ie.									N	11/15/2001	11/15/2001	0	Pt weighs 110 lbs.	PVT	PVT	Multivitamins; Calcium		Possible allergy to iodine, Flagyl and epinephrine.			1						1	Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U0677AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0179807	01/17/2002	PA	81.0	81		F	01/10/2002	Letter rec'd from pt states she rec'd flu vaccine on 10/6/01, after which she dwindled into 4 weeks of complete misery, spending nights coughing, not eating and sleeping well, lost more than 12 lbs. A visit to the doctor on 10/6 was for a check up where pt had fallen, she had a slight cold, the Dr looked at her throat and diagnosed her with laryngitis. When she went in to see the Dr that morning she told the receptionist that she had a cold and that she did not want a flu shot, she also told the Dr but he told her this vaccine was different and could be taken anytime. As a result of the shot she lost her voice for about 6 weeks, she was given Zithromx on 10/19, pt was weak				Y					N	10/06/2001	10/07/2001	1		PVT	OTH	Dyazide, Tenormin, Xanax	slight cold, laryngitis	high blood pressure			1						2	Dysphonia; Fatigue; Nasal dryness; Urine analysis abnormal; Cough; Decreased appetite; Insomnia; Laryngitis; Pharyngitis; Rhinitis; Weight decreased; Cough; Laryngitis; Oral intake reduced; Sleep disorder; Weight decreased	FLU3~SANOFI PASTEUR~U0681AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~00681AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~U0681AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Emergency room visit	Influenza
0180074	01/17/2002	CO	11.0	11		F	05/07/2002	A HCP reported that an 11 year old female received Flu Shield vaccine on 02-JAN-2002 at 10 AM. The pt's concurrent illness includes Lupus. The pt was enrolled in an unidentified research study at the time of immunization. On 02-JAN-2002 at 2 PM she lost her vision and could only see light and dark. On 02-JAN-2002 she was admitted to the hospital and a work-up was negative. The reporter noted that this symptom may be due to a Lupus flare up but is not certain. The pt was discharged from the hospital and her vision is improving. No additional information was available as of the date of this report. Follow up info received 5/6/02, from healthcare provider via telephone. The pt recovered within three days of onset. She was discharged from the hospital on 1/5/02. The pt was re-admitted to the hospital for another episode of blindness due to another lupus flare-up. The reporter is confident the blindness was not caused by Flushield but was caused by a lupus flare-up. The pt is being treted with anti-inflammatory agents (not identified). Follow up also include dpt's date of birth.				Y	Y				Y	01/02/2002	01/02/2002	0	UNK	OTH	OTH	UNK	UNK	Systemic Lupus erythematous		HQ9886714JAN2002	1						1	Blindness	FLU3~PFIZER\WYETH~4018056~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0180076	01/17/2002	VA	77.0	77		F	11/06/2000	11-9-00 HV; ? 1990-91 Reaction to  with cardiac catherization; PMD appt. 11-13-00-routine visit; 'I'm not worried about the bruising at all, I always bruise easily so that nothing to be concerned about; swelling gone; reports arms and shoulders always hurt secondary to arthritis; called HD 11/6/00 and told to call MD by the PHN. unable to reach and later contact by women in Fred. copy to CHD NSG  supervisor. Original to FHD				Y						11/03/2000	11/03/2000	0		PUB	UNK	Cozar (BP) 1 baby aspirin a  day		Reaction PCN & codeine years ago	~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Pain; Swelling	FLU3~PFIZER\WYETH~4008173~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0180085	01/17/2002	NY	45.0	45		F	12/07/2001	On 12/3/01 PM, the pt attended Influenza Clinic and received Flu Shield vaccine. She developed sweling and discomfort. She was seen by her personal physician. She was treated and discharged to home. She did not respond to writer's request to be contacted to provide follow-up information.				Y					Y	12/03/2001	12/03/2001	0	NONE	OTH	OTH	UNK	NONE	UNK			1						1	Discomfort; Swelling; Unevaluable event	FLU3~PFIZER\WYETH~4018033~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0180086	01/17/2002	WI	40.0	40		F	10/24/2001	The pt noted that approx. 8-9 hours, post vax, a red finely dispersed rash on arms, abdomen, on back between shoulder blades, scalp and lower leg. She called ER and was instructed to take Benadryl 25mg po q 6 hours prn for rash/itching. Took at 21:00 on 10/23/01 and at 04:30 on 10/24/01. Reported incident to Employee Health at 11:00. Call to regular physician.									Y	10/23/2001	10/23/2001	0		PVT	OTH	Multivitamins; Calcium tab; Synthroid 125mg po daily	NONE	NONE			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U0672AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180091	01/17/2002	NJ	38.0	38		M	11/23/2001	Pt was feeling sick with tiredness and sinus symptoms before he got the flu shot. The day after flu shot, he had a temperature of 104F, sweating, total body ache and exhausted X 4 days. He was seen at a walk-in medical care center. Missed 1 week of work. Rx'd with Naprosyn; Tylenol and ice. Dx: concomitant Viral Syndrome and a reaction to flu vaccine.									Y	10/17/2001	10/17/2001	0	NONE	UNK	MIL	NONE	Slight cold	NONE			1						1	Fatigue; Hyperhidrosis; Hypersensitivity; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U0674AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180092	01/17/2002	OH	25.0	25		F	12/21/2001	The pt noted pain in her muscle, a few days after immunization and it has persisted for 6 weeks.									U	11/08/2001	11/10/2001	2	NONE	OTH	PVT	buspirone; paroxetine	NONE	Anxiety			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U0677AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180094	01/17/2002	IN	76.0	75		F	01/04/2002	Redness and swelling at injection site. Not completely resolved but improved as of 01/04/2002.									Y	11/27/2001	11/28/2001	1		PVT	UNK	Zoloft; Dovan; ASA; CCH		GERD; Arthritis; fibromyalgia; hypertension			1						1	Injection site hypersensitivity; Oedema	FLU3~SANOFI PASTEUR~UO726AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180095	01/17/2002	TN		31		F	11/20/2001	Requested flu shot be given in hip due to previous problem last year after giving flu shot in arm had swollen axillary lymph nodes and very sore arm. Day after receiving flu shot in hip notice golf ball size knot in groin, back and leg pain. Saw MD who ordered urinalysis which was negative. Health department was notified. No reaction of this sort had been reported. Symptoms subsided and were gone within 2 weeks. Advised to confer with MD before receiving anymore flu shots.				Y						10/25/2001	10/25/2001	0	Urinalysis-negative	UNK	UNK				swollen lymph nodes~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Oedema; Pain; Subcutaneous nodule	FLU3~SANOFI PASTEUR~UO675AB~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0180107	01/18/2002	MD				F	01/16/2002	Concomitant vaccines were IPOL, Fluzone and one unspecified vaccine. On 04-OCT-2001, the pt received her first injection of Havrix. In January 2002, 3.5 months post immunization, she developed encephalitis which required hospitalization. The reporting physician believed that the encephalitis was not related to Havrix administration. As of 07-JAN-2002, the outcome of the event was unknown.					Y				U	10/04/2001	01/01/2002	89		OTH	OTH					2002000399	1						1	Encephalitis	FLU3~SANOFI PASTEUR~~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~SMITHKLINE BEECHAM~~1~IM~~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~~1~SC~~POLIO VIRUS, INACT. (POLIOVAX)~1	USA	Hospitalisation	Influenza
0180111	01/18/2002	IN	46.0	46		F	11/07/2001	Pt had Pneumovax and influenza vaccines at 10/16/2001 then had rash, pain and itching. Pt later had Steven Johnson Syndrome. The discharge summary states headahce, coagulopathy and hepatitis C.					Y	10			Y	10/16/2001	10/18/2001	2	Allergies to NSAIDS, PCN, ASA, Morphine	OTH	PUB	Inderal; Premarin; Lamictal; Elavil	LP-neg; CBC and Chem-nml	Hypertension, osteomyelitis			1						1	Coagulopathy; Headache; Hepatitis C virus; Pain; Pruritus; Rash; Stevens-Johnson syndrome	FLU3~EVANS VACCINES~E04851KA~7+~SC~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0461L~7+~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0180115	01/18/2002	MD	72.0	72		F	11/15/2001	Pt arm became swollen, hard and aches. Chills and fever for several days following vaccination.									Y	10/10/2001	10/11/2001	1		PVT	PVT		NONE	coronary artery disease, hypercholesterolemia, CVA			1						1	Injection site induration; Injection site swelling; Pain	FLU3~EVANS VACCINES~E02761HA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0180116	01/18/2002	NY	70.0	70		F	12/12/2001	Pt rec'd immunization 12/11/01 at 9:30am later in afternoon L upper arm began to hurt and developed swelling & redness involving whole upper arm. Pt called MD and was instructed to apply warm, moist wash cloth. Arm worsened, pt called MD back per pt MD couldn't fit her in so told her to go to ER. Pt was seen at ER and given an IV and IV antibiotics for an hr. Sent home with script for Cephalexin 500mg tid x 7 days. Pt said ER dx'd arm as a cellulitis.				Y					U	12/11/2001	12/11/2001	0	Had blood work 12/12/01 - no results were given	PUB	PUB	Prilosec, Cardizem, CD, Nitropatch, tylenol w/codeine	NONE	Penicillin, aspirin			1						1	Cellulitis; Injection site erythema; Injection site pain; Injection site reaction; Injection site swelling	FLU3~SANOFI PASTEUR~U0687DA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~475388~1~IM~LA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0180117	01/18/2002	CA	37.0	37		F	12/10/2001	On 11/15/01 pt felt nerve pain, numbness in left arm and hand, pain radiating across chest. 12/4/01 no numbness less pain,pain hen raising of arm over shoulder, pain when sleeping on L arm and some decreased mobility of L arm.									N	11/15/2001	11/15/2001	0		OTH	PUB	multi vitamins	NONE	NONE			1						1	Chest pain; Hypoaesthesia; Hypokinesia; Neuralgia; Pain	FLU3~SANOFI PASTEUR~U0704AB~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180120	01/18/2002		71.0			M	01/12/2002	Flu shot at Dr office. Pt reports pain is severe and has lasted  now for 10 weeks. Reports indentation in the tricep where the shot was given. The muscle goes into spasms at times and will sometimes twitch for 10 to 15 minutes at a time, the muscle is sore to the touch. The muscle feels like it is getting weaker.									U	10/26/2001			MRT & nerve testing, MRI was normal and no nerve damage shown.	OTH	OTH						1						1	Muscle spasms; Muscle twitching; Muscular weakness; Myalgia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0180121	01/18/2002	MA	8.0	8		M	11/16/2001	2 days, post vax, vomited X 1 and was lethargic all day on 11/10/01, laying around on couch with nausea and decreased appetite. Gave fluids and was doing better by 11/10/01 afternoon. No fever. Was hoarse but no sore throat. Mom concerned that the illness was due to shot, not viral GE.									Y	11/07/2001	11/09/2001	2	NONE	PVT	UNK		NONE	RAD; Allergic Rhinitis; No drug or food allergies			1						1	Decreased appetite; Dysphonia; Gastroenteritis; Lethargy; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U0676AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180122	01/18/2002	OH	46.0	46		M	12/13/2001	The pt came to his PCP's office, the day after receiving flu injection. He had a 10cm X 12cm swelling on left lateral upper arm with tender, bullous areas over lateral arm. No adenopathy.				Y					U	12/10/2001	12/11/2001	1		UNK	UNK	NONE					1						1	Dermatitis bullous; Injection site pain; Injection site swelling	FLU3~PFIZER\WYETH~4108024~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0180123	01/18/2002	CA	77.0	77		M	11/28/2001	On 11/21/01, the pt stated his arm became very painful and he was unable to raise it up. It remained painful and difficult to lift for the next several days. Pt consulted with MD and was put on cortisone and pain meds on 11/27/01. Message on 11/18/01, indicated 10% to 15% improvement.				Y					N	11/20/2001	11/21/2001	1		PUB	PVT	UNK	NONE	NONE			1						1	Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U0593AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0180125	01/18/2002	MS	68.0	68		M	10/23/2001	On 10/19/01, the pt experienced slight diarrhea. On 10/20/01 and 10/21/01, the pt experienced severe watery diarrhea, gas, weakness and general flu-like signs and symptoms. The pt denies blood or mucous in stool. The pt did not seek medical attention. He took OTC's (anti-cholinergic and Pepto-Bismol). The pt was a drug rep for many years and feels the vaccine was not manufactured correctly and is a live virus vaccine.									Y	10/16/2001	10/19/2001	3	NONE	PUB	OTH						1						1	Asthenia; Diarrhoea; Flatulence; Influenza like illness	FLU3~SANOFI PASTEUR~U0574AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180126	01/18/2002	FL	65.0	65		F	10/25/2001	I talked to the pt on the phone and this is what she relayed to me. She said she had never had the flu vaccine before but her doctor had recommended that she get one because she had a record of getting colds and had pneumonia twice. She said she had received a pneumonia vaccine previously without complications. The vaccine was given where the pt works. She said about 1 hour, post vax, she started having a stiff neck and feeling nauseated. She went home since she had received the vaccine at her workplace. She began taking Advil. She said she never took her temperature but did feel hot. She said she started feeling hot and cold and then 2 days later, she developed a cough. She went to the doctor on 10/23/01 and he told her she had the flu. She also said she had an ear infection and possibly a respiratory infection. She had started taking OTC cough medication. The doctor gave her a prescription for an antibiotic and Flonase. He told her the antibiotic would not work on the flu. When I talked to her, she was already starting to feel better but sounded congested over the phone.				Y					Y	10/17/2001	10/17/2001	0	NONE	OTH	OTH	BP medication and OTC cough medication					1						1	Chills; Cough; Ear disorder; Feeling hot; Influenza; Musculoskeletal stiffness; Nausea; Respiratory tract infection	FLU3~SANOFI PASTEUR~U0678AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0180128	01/18/2002	MD	3.0	3		F	11/13/2001	The pt developed wheezing, desaturation and generalized urticaria, within 5 minutes, post vax. Rx'd with epinephrine, Benadryl and steroids.				Y					Y	11/12/2001	11/12/2001	0		PVT	PVT		NONE	? A-V Canal			1						1	Hypoxia; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U0688AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0180130	01/18/2002	WI	63.0	63		F	11/27/2001	developed chills late afternoon (11-26-01); 5:00-6:00 pm increased chills, body aches, 102 fever, shooting pains t/o body with breathing-continued into 1/27-no fever as of 3:30 pm & starting to feel better. mild soreness @ both injection sites.									Y	11/26/2001	11/26/2001	0	NONE	PUB	PVT	Prempro daily	NONE	NONE			1						1	Chills; Pain; Pyrexia	FLU3~PFIZER\WYETH~4018043~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~476952~UNK~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0180131	01/18/2002	SD	36.0	36		F	10/23/2001	Received influenza vaccine 1230 10/22/01. at 1500 headache, tightness in throat, wheezing & effort to breathe. continued throughout evening & nigh. still lump in throat 10-23-01 am & wheezing 1300 10/23 wheezy										10/22/2001	10/22/2001	0	10/23 1400 still symptoms	PUB	UNK						1						1	Dyspnoea; Headache; Throat tightness; Wheezing	FLU3~SANOFI PASTEUR~U0692AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180132	01/18/2002	IL	52.0	52		F	10/23/2001	Severe swelling left arm shoulder to hand pain in palmar surface near 5th digit . Qquil prescribed by PCP									Y	10/17/2001	10/18/2001	1	NONE	PUB	PUB	Dynacinc, Esgic, Levoxine, Amitryteline	NONE	fibromyalgia, hypertension, hypothyroidism			1						1	Injection site swelling	FLU3~SANOFI PASTEUR~U0574AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180139	01/18/2002	AZ	68.0	68		F	11/09/2001	given pneumonia vaccine 11/8/01 as part of flu clinic at a senior center. (by me) reported a temperature of 99.5, arm redness edema from shoulder to elbow, mylagia & arthralgia on 11/09/01, started about 5 pm 11/8/01									Y	11/08/2001	11/08/2001	0	has known positive ppd	OTH	PVT	Zocor, Fosamax	NONE	Hyperlipidemia, osteoporosis			1						1	Arthralgia; Erythema; Myalgia; Oedema; Pyrexia	FLU3~EVANS VACCINES~E04851KA~6~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1052L~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0180177	01/22/2002	CA	57.0	57		M	01/09/2002	On 1/1/02, developed inability to smile; left facial Bell's Palsy and drooping eyelids. Saw doctor on 1/2/02 and was placed on Prednisone 80mg po and decreasing dose and acyclovir 800mg po 5 X ?. Sees MD on 1/16/02. Said Bell's Palsy unrelated to flu shot but pt said the F/U sheet said to report anything unusual.									N	12/20/2001	01/01/2002	12		OTH	PVT		NONE				1						1	Facial palsy	FLU3~SANOFI PASTEUR~U0711AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180179	01/22/2002	WI	39.0	39		F	01/11/2002	Felt heaviness in feet, knees, hips and joint pain. Sought evaluation with lab work done. This vaccine was given as part of a wellness program for employees.				Y					Y	11/15/2001	11/27/2001	12	ESR; CBC	PVT	PVT	UNK	NONE	Chronic neutropenia			1						1	Arthralgia; Sensation of heaviness	FLU3~SANOFI PASTEUR~U0715AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0180193	01/22/2002	CA	76.0	76		F	01/11/2002	Less than 12 hours, post vax, the pt developed a local left arm pain, redness and tenderness that progressed over 36 hours, then began to improve. At 48 hours, she had chest tightness that began without wheezing. At 72 hours, local arm symptoms responding nicely to ice/heat. Lungs clear on exam.				Y					Y	01/08/2002	01/08/2002	0	NONE	PVT	UNK	Codorone; Lasix; Aldactone; Synthroid; Coumadin; Coreg; Lotensin; Flovent; Premarin	NONE	Sulfa allergy; Non-ischemic Cardiomyopathy; Asthma; Arrhythmias			1						1	Chest discomfort; Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U0592AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0180197	01/22/2002	AZ	75.0	74		F	01/11/2002	The pt complained of left upper arm pain with redness and swelling. Time course was about 24 hours. The treatment was ibuprofen/APAP.									Y	01/09/2002	01/10/2002	1	NONE	PVT	PVT	Levoxyl; Premarin; Rocaltrol; Ultram	NONE	Thyroidectomy			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~PFIZER\WYETH~4018046~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1351L~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0180198	01/22/2002	CA				M	01/10/2002	Acrocyanosis without fever less than twenty-four hours after moderate induration at the site.									Y	01/09/2002	01/10/2002	1	NONE	MIL	MIL	NONE	Gastroenteritis	Constipation			1						1	Cyanosis; Injection site induration	DTAP~SMITHKLINE BEECHAM~524A2~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~V0674A7~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180200	01/22/2002	AR	46.0	46		F	11/14/2001	Got the flu shot around 08:20 and then 30-40 minutes later, pt felt funny; like she had taken something too strong for her. She was lightheaded and could not drive. She called the health dept. about 10:00 and was advised to see MD. MD placed her on Depo-Medrol and instructed that if she was not better by night, to go to the ER.				Y					Y	11/08/2001	11/08/2001	0		PUB	OTH	NONE	NONE	Heart condition; High BP; Hole in heart; Liver disease		AR025	1						1	Dizziness; Tension	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0180202	01/22/2002	AR	32.0	31		F	12/03/2001	Arm reddened, hot to touch same day of injection; increased temperature of 102.6 degrees F; asking and N/V same day after shot. 12/05/01 arm continuing to hurt like swollen muscle and pain shooting to elbow when using or lifting objects.									N	10/29/2001	10/29/2001	0		PUB	UNK	NONE	NONE	NONE		AR01-49	1						1	Erythema; Feeling hot; Pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U0670AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180203	01/22/2002	AR	14.0	14		F	12/05/2001	Numbness and tingling in face, lips, tongue, arm and fingers: also swelling of tongue and lips: vomiting :HA all s/s started early am 12-04-1: saw RNP @ the doctor's office-she (per pt's gm) stated that pt had a stomach virus, probably unrelated to the flu shot.				Y					Y	11/27/2001	12/04/2001	7		PUB	PUB		NONE	NKDA		AR01-48	1						1	Hypoaesthesia; Swelling; Viral infection; Vomiting	FLU3~SANOFI PASTEUR~U0705AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0180204	01/22/2002	AR	34.0	34		F	11/30/2001	Pt stated she had a flu shot 11/27/2001 and had an allergic reaction to shot. Left upper arm reddened, inflamed, swollen and itching since shot on Tuesday. Pt's states she is now having breathing difficulty at this time, that she is allergic to latex and when comes in contact to latex, had to go to ER for breathing difficulties.				Y					Y	11/27/2001				PUB	UNK	NONE	NONE	Latex gloves		AR0150	1						1	Dyspnoea; Erythema; Hypersensitivity; Inflammation; Oedema; Pruritus	FLU3~SANOFI PASTEUR~UO705AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0180319	01/23/2002	MT	5.0	5		M	12/27/2001	Onset of symptoms 3-4 hours after injection: gasping difficulty breathing, cyanotic lips, rash on upper back				Y					Y	11/26/2001	11/26/2001	0	NONE	PUB	PVT	NONE	NONE	premature birth, RSV as infant, borderline asthma		MT0201	1						1	Cyanosis; Dyspnoea; Rash	FLU3~PFIZER\WYETH~4018033~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0180320	01/23/2002	CO	28.0	29		M	01/04/2002	On 1/3/02 in morning , pt. noticed slight swelling of lymph nodes in his neck and slight sore throat. These 2 signs & symptoms continued to 1/4/02. Pt. denies fever, cough, nasal congestion, rash and general malaise. Advised to call physician if S/S increased.  1/7/02 spoke with pt. no swollen lymph nodes, no fever, but still has slight sore throat and nasal discharge									U	12/27/2001	01/03/2002	7	NONE	PUB	PVT	Advil, cold medicine	NONE	NONE		C002001	1						1	Lymphadenopathy; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U0710AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1330K~1~IM~LA~HEP A (VAQTA)~1|TD~CONNAUGHT LABORATORIES~U0382AA~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~1338K~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0180324	01/23/2002	NY	22.0	32		F	01/13/2002	Within 1 hour of shot, I got very bodyaches & very tired. Approximately 4 hours later-vomiting stomach ache. this lasted 4 days; did not take any medicine-I just let it run its course.									Y	12/05/2001	12/05/2001	0		PVT	OTH	artho Novum-birth control	NONE	Allergic to aspirin,cats, dogs, dust mites, rabbits,-hay fever			1						1	Abdominal pain upper; Lethargy; Pain; Vomiting	FLU3~SANOFI PASTEUR~U0708AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180332	01/23/2002	MI	68.0	66		F	01/14/2002	The client complained of a sore spot and can't lift arm. She has had a history of shoulder problems. She was advised to apply heat and ice. On 11/16/01, the client stated her was better.									Y	11/11/2001	11/12/2001	1	NONE	PUB	PVT		NONE	NONE			1						1	Hypokinesia; Pain; Joint range of motion decreased; Myalgia	FLU3~SANOFI PASTEUR~U0703AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0995L~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U0703AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0995L~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0180333	01/23/2002	MI	39.0	39		M	01/14/2002	Client complained of sore arm and unable to lift arm. Applied ice packs and was instructed to see a physician if not better. Had no swelling or redness.									Y	11/16/2001	11/19/2001	3	NONE	PUB	PVT		NONE	NONE			1						1	Hypokinesia; Pain; Joint range of motion decreased; Musculoskeletal stiffness; Myalgia	FLU3~SANOFI PASTEUR~U0703AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0996L~UNK~IM~~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0180334	01/23/2002	MI	71.0	71		F	01/14/2002	The client complained of redness and swelling on 11/01/01 which got bigger than at the time of the injection. The client was seen by a physician and was prescribed an antibiotic for cellulitis. On 1/8/02, the cellulitis was completely resolved.									Y	10/30/2001	11/01/2001	2	NONE	PUB	PVT		NONE	NONE			1						1	Cellulitis; Injection site erythema; Injection site swelling; Cellulitis; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1449K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1449K~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0180336	01/23/2002	MN	36.0	36		F	11/05/2001	The pt developed multiple myalgias, arthralgias, lower extremity weakness and swollen and painful joints.				Y					Y	10/16/2001	10/17/2001	1		PVT	PVT	NONE	NONE	Iron deficiency anemia			1						1	Arthralgia; Joint swelling; Muscular weakness; Myalgia	FLU3~SANOFI PASTEUR~U0685AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0180359	01/23/2002		5.0			F		A report was received from French R agency on 01/10/2002, concerning a 5 year old female pt who experienced asthma crisis resolution in hospitalizations 5 days after receiving the second dose injection of fluvirin on 10/27/2001; the first having been on 10/03/2001. The pt had a medical history of cyctic fibrosis. During the night of 11/01/2001-11/02/2001, the pt experienced on asthma crisis. The pt was hospitalized in the Pediatric dept with fever (37.8 deg. C) and congestion. The pt recovered without sequelae following IV antibiotic and corticosteroid treatment.					Y					10/03/2001	11/01/2001	29		OTH	OTH	UNK		Cystic fibrosis		PJP200200030	1						1	Asthma; Pyrexia; Asthma; Pyrexia; Upper respiratory tract infection	FLUX~UNKNOWN MANUFACTURER~769813~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~EVANS VACCINES~759813~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Hospitalisation	Influenza
0180455	01/24/2002	WI				M	01/17/2002	It was reported that an adult male pt was administered an Influenza vaccine on 20-OCT-2001. On 21-OCT-2001 the pt experienced a temperature of 100-101F, diarrhea and myalgia that lasted 8 days. Myalgia in his back and both lower extremities persists. Pt was evaluated by both his internist and pulmonologist and given Percocet for the myalgia.				Y					U	10/20/2001	10/21/2001	1		UNK	UNK	Medication included 2 anitbiotics, Azamacort, Atrovent, Ethambutol, Premaproxal and Quinine.		Pt has current medical history of emphysema, MAI, muscle cramps and spasms.		U2002000340	1						1	Diarrhoea; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0180462	01/24/2002	OH	71.0	70		F	01/10/2002	The pt developed diffuse interstitial disease of the lungs about 10 days, post vax, Pneumonia. Annual follow up states- I do not believe the pts pneumonia was caused or related to the flu vaccine. The discharge summary states diarrhea, anxiety, hypoglycemia, hyperkalemia and hypoalbuminemia.			Y		Y				U	11/01/2001	11/12/2001	11	CXR; CT Scan; Lung biopsy	PVT	OTH	Premarin	NONE	Mild hyperlipidemia, osteoporosis.			1						1	Anxiety; Diarrhoea; Hyperglycaemia; Hyperkalaemia; Hypoproteinaemia; Interstitial lung disease; Pneumonia	FLU3~SANOFI PASTEUR~U0697AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0180464	01/24/2002	MI	68.0	68		M	01/16/2002	The pt was admitted to the hospital on 1/9/02 with complaints of sore shoulder, pain and swelling after vaccines on 12/11/01. Left shoulder septic; possible abscess. It was aspirated and cultured. All tests were negative. MD discharged the pt to home on 1/11/02.				Y	Y	2			Y	12/11/2001	01/09/2002	29	Left shoulder aspirated and cultured-neg	PUB	PVT	UNK	NONE	NIDD; hypertension			1						1	Injection site abscess; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U0575AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0690K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0180468	01/24/2002	TX	61.0	61		F	01/16/2002	One to 1.5 hours after vaccine I developed rapid heartbeat, SOB, severe pain in chest radiating out to left arm. reported tp physician on call at hospital. Advised to seek medical attention.				Y	Y	1			Y	10/31/2001	10/31/2001	0		PVT	PVT	Dilantin; Urispas; Macrobid; lactulose; clidinium; Prempro; Ocupress; Xalantan; Nasonex; Claritin	NONE	Allergies to codeine and sulfa drugs, glaucoma; IBS; hydrocephalus, CAD.			1						1	Dyspnoea; Heart rate increased; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0180469	01/24/2002	SD	3.0	3		F	01/14/2002	Pt had her first influenza injection December 5th. On January 7th the child was brought in for the second immunization and the mother reported that the site got a little sore the last time. On 01/08/2002 the child was seen at the medical clinic and was admitted to the hospital with grand mal seizures and transferred to a different hospital a later that day.					Y	3			Y	01/07/2002	01/08/2002	1		PUB	PUB	Lamictal; Tomax	UNK	Moderately abnormal EEG 8/2001. Child has elevated liver enzymes from seizure medication. Petit mal seizures since 10 months of age related to left mesial temporal sclerosis.			1						1	Grand mal convulsion; Injection site pain	FLU3~PFIZER\WYETH~4018029~2~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0180470	01/24/2002	KS	78.0	78		M	10/26/2001	Pneumonia vaccine given approximately 2 PM on 10/24/2001 in left deltoid. Arm was slightly tender. On morning of 10/26/2001, he noticed soreness and visible swelling on inner aspect above left elbow discomfort. Did not call doctor's office.									Y	10/24/2001	10/26/2001	2	NONE	PUB	PVT	NONE	NONE	NONE		KS200144	1						1	Oedema; Pain; Tenderness	FLU3~SANOFI PASTEUR~UO574AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0820K~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0180472	01/24/2002	KS	66.0	66		F	11/06/2001	The client came back to the health dept on Monday, 11/5/01. She states that on Saturday, she felt achy and just not right. Then she woke up on Monday morning and had a large red spot approx. 3-4 below the injection site. The client states that the same thing happened after her last pneumonia and tetanus shots. Instructed her to notify physician and to take Benadryl to see if that helps.									U	11/02/2001	11/05/2001	3	NONE	PUB	PUB	UNK	NONE		Redness at the injection site and achy~Pneumo (no brand name)~~0.00~In Patient	KS200147	1						1	Injection site erythema; Pain	FLU3~SANOFI PASTEUR~U0574AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180474	01/24/2002	KS	38.0	38		F	11/29/2001	15 minutes, post vax, the client's right palm became numb. It is still numb at 11:00. The vaccination was done off site. At 16:50, call to client and states the feeling has returned.									Y	11/29/2001	11/29/2001	0		OTH	PVT	NONE	NONE	NONE		KS200150	1						1	Hypoaesthesia	FLU3~SANOFI PASTEUR~U0574AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180475	01/24/2002	KS	48.0	48		F	11/23/2001	Pt states she had flu shot on Monday, 11/19/01 and chills started on that evening and has persisted along with weakness from 11/19/01 to 11/23/01. No topical reaction. Informed pt that she was most likely exposed prior to vaccination. Recovery in process.									U	11/19/2001	11/19/2001	0		OTH	PVT		NONE			KS200151	1						1	Asthenia; Chills	FLU3~PFIZER\WYETH~4018033~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0180476	01/24/2002	KS	55.0	55		F	11/20/2001	The pt received injection at 10:30 on 11/19/01 in the left deltoid. By 14:30, the pt complained of symptoms of extreme pain and inability to lift arm. On 11/26/01, the pt is able to move arm and has no pain. Physician thinks vaccination caused acute bursitis.				Y					Y	11/19/2001	11/19/2001	0		PUB	PUB	Combovent; Advair; Avolid		COPD; Hypertension		KS200152	1						1	Bursitis; Hypokinesia; Pain	FLU3~PFIZER\WYETH~4018038~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0945K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0180481	01/24/2002	NC	68.0	66		F	01/16/2002	The pt states that after the injection, she couldn't sleep that night. Went to private MD on 1/15/02 because of severe pain. She states the pain comes and goes.				Y					U	10/25/2001	10/25/2001	0		PUB	UNK		NONE	Allergy to codeine			1						1	Pain; Sleep disorder	FLU3~SANOFI PASTEUR~U0602AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0180482	01/24/2002	IA	68.0	68		F	01/14/2002	The flu shot was administered on 11/29/01 and was painful at the time of injection (RD). Immediately lost ROM and was unable to move arm towards back such as to hook bra or find seat belt. Can't reach opposite side. Can raise arm straight up. Pain in arm at night in the muscle between shoulders and elbow. The doctor thought that the injection hit a nerve. Using heat, exercises and Vioxx X 19 days. Shot given high in deltoid; 1 finger below bone. Above treatments made no difference.				Y					N	11/29/2001	11/29/2001	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Hypokinesia; Myalgia; Neuropathy	FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0180483	01/24/2002	IA	64.0	63		F	01/14/2002	Injection given on 11/29/01 in left deltoid. Immediately, shot was painful and bled a lot. Was given high on shoulder about 1 finger below the bone and was bruised after 15 minutes. Arm ached all day and night and the next day. There was a knot at the site and is still dime-sized.									Y	11/29/2001	11/29/2001	0	NONE	PUB	PUB	Hormone replacement	NONE	NONE			1						1	Contusion; Injection site haemorrhage; Injection site mass; Injection site pain; Ecchymosis; Injection site mass; Pain	FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~UO710AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0180485	01/24/2002	IL	48.0	48		F	01/15/2002	24 hours, post vax, had severe muscle weakness (lasted 48 hours), severe redness at injection site with bruising (lasting over 4 weeks), unable to lift arm (injection site) for 72 hours and fever for 48 hours.									Y	12/06/2001	12/07/2001	1		OTH	PUB	NONE					1						1	Contusion; Hypokinesia; Injection site erythema; Muscular weakness; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0180486	01/24/2002	MI	51.0	51		F	01/14/2002	Redness, swollen and painful at the injection site. Also, felt a knot. Client received flu and pneumovax in the same site. On 11/5/01, still had pin-size knot but no redness. On 1/17/02, resolved.									Y	10/27/2001	10/31/2001	4	NONE	PUB	PVT		NONE	NONE			1						1	Injection site erythema; Injection site mass; Injection site pain; Injection site swelling; Injection site erythema; Injection site pain; Injection site swelling; Rash; Skin nodule	FLU3~SANOFI PASTEUR~U0685AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1449K~UNK~IM~~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1449K~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0180487	01/24/2002	IA	51.0	51		F	01/14/2002	Flu shot given in right deltoid on 11/29/01. Shoulder and arm sore and warm. Upper forearm hurts at night. Can't lift left arm straight out or to reach to back such as to hook bra or retrieve seat belt. Saw doctor and tried ibuprofen 800mg with heat on arm with no relief. Dx'd with bursitis and then given anti-inflammatory with no help. Saw Ortho doctor and was given cortisone. Dx'd with tendonitis and to do exercises X 1 week.				Y					N	11/29/2001	11/29/2001	0	X-rays-tendonitis	PUB	PUB	Advair bid	NONE	Asthma			1						1	Bursitis; Hypokinesia; Injection site pain; Injection site warmth; Pain; Tendonitis; Feeling hot; Injection site reaction; Joint range of motion decreased; Tendonitis	FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0180491	01/24/2002	WI	39.0	39		M	01/15/2002	4 day, post vax, I noticed a large lump in my left armpit. After taking Naprosyn, it died down, after 4 days.				Y					Y	01/06/2002	01/10/2002	4		MIL	MIL						1						1	Lymphoedema	FLU3~SANOFI PASTEUR~U0674AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~CONNAUGHT LABORATORIES~UA444AA~UNK~SC~LA~MENINGOCOCCAL (MENOMUNE)~1|TD~CONNAUGHT LABORATORIES~U0464AA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1|TYP~CONNAUGHT LABORATORIES~R0826~UNK~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0180496	01/24/2002	KS	40.0	40		F	01/15/2002	Hives developing in different areas; not all at the same time. It started with gluteal area, moved to elbows, arms and waist. It disappears and reappears in different areas. No redness or irritations around the injection sites. Allergic reaction.									Y	01/12/2002	01/13/2002	1		MIL	MIL		NONE	Just seasonal allergies			1						1	Hypersensitivity; Urticaria	FLU3~SANOFI PASTEUR~U0702AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|YF~CONNAUGHT LABORATORIES~UA341AA~2~SC~RA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0180535	01/25/2002	MA	64.0	64		F	01/18/2002	A loss of hearing in right ear (complete); vertigo. Also given medication.					Y			Y	N	10/24/1998	10/25/1998	1	Hearing test *Follow-up received on 02/12/03: PT wrote, I still have virtigo, when I move too quickly. Also totally loss of hearing in my right ear. No hearing aid will help. Our family and myself will hever have another flu shot.	PUB	OTH		NONE	NONE			1						1	Deafness permanent; Vertigo	FLU3~CONNAUGHT LABORATORIES~0980570~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0180538	01/25/2002	MD	37.0	36		F	01/15/2002	Pt rec'd bone scan w/dye 12/20/01. Rec'd flu vaccine 12/21/01. Pt states arm was painful after shot, woke at 2am 12/22/01 with pain in R arm, used a heating pad. Pain worsened over the next 2 days accompanied by swelling in R axilla and palpation of a lump. Pt went to ER 12/24/01, Temp - WNL she was told she had a swollen lymph node  related to the vaccine. Pt states swelling is slowly subsiding.				Y					N	12/12/2001	12/22/2001	10		PUB	PUB	NONE	Back spasm	Asthma and environmental allergies		VA02002	1						1	Injection site mass; Injection site pain; Lymphadenopathy; Swelling	FLU3~PFIZER\WYETH~4018046~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0180540	01/25/2002	NY	19.0	19		M	01/15/2002	One hour after administration of PPD and flu shot, pt felt dizzy. Stated his skin feels hot but he is cold. No complaints of shortness of breath. Has had no new foods or detergents. Mild urticaria noted on both forearms and hands. No itching. No treatment given. Pt just wanted it documented.									Y	12/03/2001	12/03/2001	0	V/S WNL	MIL	MIL	PPD	NONE	NONE			1						1	Dizziness; Feeling cold; Skin warm; Urticaria	FLU3~SANOFI PASTEUR~U0704AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180541	01/25/2002	MA	43.0	43		F	01/20/2002	Approx. 24 hours after flu shot I became itchy and covered neck to feet in hives. Went on Benadryl.				Y					Y	12/08/2001	12/09/2001	1		PUB	PUB			NONE	Hives~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0180543	01/25/2002	WV	46.0	45		F	01/23/2002	The pt was vaccinated on 11/16/2001. Two days later she developed left shoulder, elbow and wrist joint pain. No reaction on the injection site. Pain above persists till present 01/23/2002.									N	11/16/2001	11/18/2001	2	NONE	PVT	PVT		NONE	Fibromyalgia			1						1	Arthralgia; Shoulder pain	FLU3~SANOFI PASTEUR~V0710AD~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180544	01/25/2002	IA	44.0	44		F	01/14/2002	The pt received injection on her left deltroid on 10/08/2001. Injection was immediately painful and deltoid area swelled up. Now she has decreased range of motion on her arm and she can't swing toward back or twist to hook her buckle seat belt. Arm is weak and she can't reach arm above her head. It's very painful at night and it aches all the time. Also, laying down causes more pain.				Y					N	10/08/2001	10/08/2001	0	Physical therapy for three times a month.	PUB	PUB	NONE	NONE	NKA-Mitral Valve prolapse			1						1	Hypokinesia; Injection site oedema; Injection site pain; Muscular weakness; Pain; Bursitis; Injection site pain; Injection site swelling; Joint range of motion decreased; Neck pain; Bursitis; Hypokinesia; Injection site reaction; Muscular weakness; Myalgia; Tendonitis; Injection site reaction; Injection site swelling; Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~4	USA	Emergency room visit	Influenza
0178686	01/28/2002	IL	43.0	43		F	11/30/2001	It was reported that a 43 year old female pt received a Fluzone SV '00-'01 vaccination on 12/5/00. The pt developed flu-like symptoms (aches, congested and continuous fever). On 12/7/00, the pt was seen in the physician's office. The physician prescribed antibiotics for a week and the symptoms never resolved. The pt began to vomit frequently. On 12/19/00, she was admitted to the hospital. The pt was hospitalized for 3 weeks and is now on dialysis, 3 X a week. The pt is the reporter and did not believe that her physician ever reported this event.				Y	Y	22		Y	U	12/05/2000	12/07/2000	2	Glomeruls basement membrane antibodies; IgG-positive; Increased BUN, Creatinine; Renal biopsy; Glomerulonephritis	PUB	UNK	Albuterol; Pulmicort Inhaler	NONE	Asthma; Allergic Rhinitis		U2001012100	1						2	Blood creatine phosphokinase increased; Blood urea increased; Glomerulonephritis; Immunoglobulins increased; Nasal congestion; Pain; Pyrexia; Renal failure; Vomiting; Anaemia; Apnoea; Asthenia; Faeces discoloured; Glomerulonephritis; Goodpasture's syndrome; Pharyngitis; Pulmonary oedema; Pyrexia; Rash; Renal failure; Renal failure acute; Sinus congestion; Vomiting	FLU3~AVENTIS PASTEUR~U0422AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~AVENTIS PASTEUR~U0422AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Hospitalisation,Disabling	Influenza
0180568	01/28/2002	NY	45.0	45		F	01/09/2002	3 days post vax, the pt developed progressive bilateral leg weakness, fever and cough. 5 days post vax, she developed paraplegia and sensory impairment to the T6-T7 level (pin prick, light touch, temperature). The pt was treated with IV steroids and discharged to a long-term care facility without any improvement on 12/11/01. Pt with PHH sign for MS and an episode of acute transverse myelitis and paraplegia.					Y	6		Y	N	11/28/2001	12/01/2001	3		UNK	UNK		MS	MS			1						1	Cough; Multiple sclerosis; Muscular weakness; Myelitis transverse; Paraplegia; Pyrexia; Sensory disturbance	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0180572	01/28/2002	FL	24.0	23		F	01/24/2002	Employee fainted and was incoherent approx. one hour after flu shot injection was given. On 12/12/2001- ER visit and on 12/13/2001-follow up Dr. office visit				Y					Y	12/12/2001	12/12/2001	0	NONE	OTH	PUB	BCP and Vitamins	NONE	NONE			1						1	Incoherent; Loss of consciousness	FLU3~EVANS VACCINES~E12461MA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0180574	01/28/2002	SC	66.0	66		F	10/18/2001	The pt developed swelling and erythema 11-12cm below vaccine site 3-4 hours after injection. Ice was applied and then the swelling was down slightly.									U	10/17/2001	10/17/2001	0	NONE	PUB	PUB	NONE	NONE			0153	1						1	Erythema; Swelling	FLU3~SANOFI PASTEUR~U0673BA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180576	01/28/2002	MD	60.0	60		F	01/17/2002	The pt developed left hip pain 24 hours later and 11x6cm rash at injection site.									U	01/15/2002	01/16/2002	1		PVT	PVT		NONE	Allergies			1						1	Injection site rash; Pain	FLU3~SANOFI PASTEUR~U0727AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0995L~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0180577	01/28/2002	NC	47.0	46		F	07/04/2001	Approx. 48 hrs after vaccine, pt reports shaking chils with nausea and induration at injection site that developed that night of the vaccine. Symptoms lasted a week then resolved completely. Pt also  had pneumonia in April.									Y	02/21/2001	02/21/2001	0	NONE	PVT	OTH	Ortho-cyclen Prevacid MVI	NONE	NONE			1						1	Chills; Injection site induration; Nausea; Pneumonia; Tremor	FLU3~SANOFI PASTEUR~60436AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~SMITHKLINE BEECHAM~684C6~1~IM~RA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~T0187~1~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|JEV~SANOFI PASTEUR~EJN196B~1~SC~RA~JAPANESE ENCEPHALITIS (JE-VAX)~1|PPV~MERCK & CO. INC.~1448K~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0180578	01/28/2002	MI	31.0	32		F	11/27/2001	Within 1 1/2 hours the pt broke out in hives localized to both arms and experienced tightness in chest with some difficulty in breathing. Called provider at clinic, told to take Benedryl. Pt took 2 tps. fell asleep and woke up 2 hrs. later. Hives were gone, and breathing was  okay. Next day, she feels swollen and achy.									Y	11/26/2001	11/26/2001	0		PUB	UNK	Depo birth control, Motrin 800mg	NONE	NONE		MI2001104	1						1	Chest discomfort; Dyspnoea; Pain; Swelling; Urticaria	FLU3~SANOFI PASTEUR~U0700AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0923L~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0180579	01/28/2002	PA	42.0	42		M	01/18/2002	The pt developed knee pain and stiffness in 12/06/2001. On 12/08/01 he developed some weakness in hand and had difficulty in coordination.				Y					U	12/03/2001	12/06/2001	3		OTH	OTH		NONE	UNK			1						1	Arthralgia; Coordination abnormal; Joint stiffness; Muscular weakness	FLU3~SANOFI PASTEUR~U07120A~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0180580	01/28/2002	VA	2.0	2	.3	M	01/22/2002	Vaccine was administered on 01/07/2002. On 01/21/2002, pt developed quarter sized rednes around the site of Varivax which was administered on the left thigh.				Y					Y	01/07/2002	01/21/2002	14	NONE	PVT	PUB		NONE	Reactive airway disease, allergic rhinetis			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~00690AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0985L~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0180597	01/28/2002	KY				M	11/21/2001	Post vax, the pt developed chills, congestion and fever.									U					UNK	UNK			BPH; HTN; COPD			1						1	Nasal congestion; Pyrexia	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180598	01/28/2002	IL	72.0	72		F	01/09/2002	Became sick after the flu shot, 2 years in a row. Post vax, the pt developed sinus infection, ear infection, throat infection, eye infection and headaches. Not all at the same time but continuing for about 3 months. Did no get a flu shot in 2001. Did not get sick again. The doctors did not believe the flu shots caused it.									Y	11/01/2000	11/01/2000	0		UNK	UNK	Allergy meds		Allergies; developed glaucoma in 2001			1						1	Ear disorder; Eye disorder; Headache; Infection; Pharyngitis; Sinusitis; Vaccine positive rechallenge	FLUX~UNKNOWN MANUFACTURER~~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0180605	01/28/2002	KY	54.0	54		M	11/15/2001	Hives									U	11/15/2001	11/15/2001	0		UNK	UNK			GERD; Sleep Apnea; PSTD; HTN; Diabetes			1						1	Urticaria	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180627	01/29/2002	MA	78.0	78		F	01/18/2002	The pt developed a transverse myelitis, weakness, numbness of both legs, inability to urinate and difficulty with morning bowels. She has improved.  Patient is walking without a walker, feels like his strenght is not yet fully back to normal.				Y	Y	34	Y		Y	11/27/2001	11/29/2001	2	NONE	PVT	UNK	NONE	MRI of L/S and T Spines-nml; LP and lab data	NONE			1						1	Anuria; Asthenia; Constipation; Hypoaesthesia; Myelitis transverse	FLU3~PFIZER\WYETH~4018028~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0180632	01/29/2002	PA	45.0	45		F	11/16/2001	Pt developed 1cm erythematous macular exanthem, non pruritic at injection site L arm. No fever,No previous reaction to flu vaccine. No flu or cold symptoms 2 wks prior to receiving vaccine. No allergies to eggs.									Y	11/13/2001	11/14/2001	1	NONE	PVT	PVT	Toprol XL 50mg 1/2 tab, Premarin 0.9mg	None	PCN, sulfa, codeine, Darvon		PA0203	1						1	Rash; Rash macular	FLU3~EVANS VACCINES~E04831KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0180633	01/29/2002	PA	17.0	0	.0	F	11/16/2001	Pt reports within 24 hr's after receiving vaccine they developed 5cm diameter circular, pruritic macular exanthem at injection site. No fever, no previous reaction to flu vaccines, no cold or fever symptoms 2 wks prior to receiving vaccine, No allergy to eggs. Pt was given 10 days antibiotic (Keflex) for cellulitis.									Y	11/06/2001	11/07/2001	1	11/8 - CBC/normal	PVT	PVT	NONE	NO	NO		PA0204	1						1	Rash macular; Rash pruritic	FLU3~EVANS VACCINES~E04831KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0180634	01/29/2002	PA	51.0	46		F	12/05/2001	Pt reported that on the same night she rec'd the flu vaccine (11/29/01). She developed welts to her face with itching. This persisted Thursday evening 11/29/01 and Friday 11/30/01. She considered taking Benadryl, but didn't as symptoms didn't progress, she continues to have spots on her face as of 12/4/01, but no pruritis. She also had itching to her scalp, neck and arms but did not observe any welts.									U	11/29/2001	11/29/2001	0		PUB	PUB	Levothroid, Cipro for food poisoning.	NONE	? allergy, hypothyroidism, unknown food allergy		PA0205	1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0727AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180635	01/29/2002	PA	44.0	44		F	11/19/2001	Pt rec'd flu vaccine 11/16/01. On 11/17/01 R arm at injection site developed hives, welt, itchy, redness, site warm to touch. On 11/19/01 R deltoid site size of small lemon, warm to touch and still itchy. Pt put ice on the area on 11/17 and warm compress 11/18/01. On 11/26/01 inflammation subsiding.									Y	11/16/2001	11/17/2001	1	NONE	PUB	PVT	NONE	NONE	Asthma	Swelling, tachycardia~Tetanus Toxoid (no brand name)~~30.00~In Patient	PA0206	1						1	Injection site reaction; Injection site warmth; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0706AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180637	01/29/2002	TX	62.0	62		F	01/11/2002	40 days after vaccination, pt called to report redden blister area on L upper outer arm. Approximately 4 1/2 (shoulder), outer arm area, 2 large blisters developed & has continued to have area of tiny blisters, redness and pain to L arm from her shoulder to finger tips, pain from shoulder to back. Several areas of blisters, redness down arm continue.				Y					U	12/03/2001	01/11/2002	39		PUB	PUB	antibiotics, IGM, Premarin, multi-vitamins, aspirin	NONE	1/15/02 herpes zoster		TX02012	1						1	Back pain; Blister; Injection site erythema; Injection site vesicles; Pain	FLU3~SANOFI PASTEUR~60588AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~CONNAUGHT LABORATORIES~60154AA~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0180641	01/29/2002	VA	0.5	0	.5	M	01/23/2002	Pt rec'd DTaP, Prevnar, Flu vaccine and Synagis. developed erythema multiforme 1/13/02. On 1/15/02 pt presented to office. Tx Atarax improved.				Y					Y	01/09/2002	01/13/2002	4	CBC- normal	PVT	PUB	Synagis-Med-immune-007944-LT-0	NONE	Prematurity 32 wks			1						1	Erythema multiforme	DTAP~SMITHKLINE BEECHAM~516A2~3~IM~LL~DTAP (INFANRIX)~1|FLU3~PFIZER\WYETH~4018056~1~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PNC~PFIZER\WYETH~482371~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0180642	01/29/2002	MA	53.0	53		F	01/23/2002	Approx. 20 minutes, post vax, the pt stated that she didn't feel right. She complained of being bright red all over. She complained of nausea, epigastric pain and tingling in all extremities. No SOB. BP was 91/70; Pulse was 100. She was given Benadryl 25mg at 10:00. At 10:30, there was no improvement and EMS were called. The pt was transported to the hospital at 10:50. Her eyes were bloodshot. She was treated with Zantac, Benadryl and prednisone at the hospital.				Y					Y	12/12/2001	12/12/2001	0		OTH	PVT	Naprosyn; Zocor; Vasotec		Bursitis; Hypertension; Hypercholesterolemia; Allergy to Flexeril and penicillin			1						1	Abdominal pain upper; Blood pressure decreased; Erythema; Feeling abnormal; Heart rate increased; Nausea; Ocular hyperaemia; Paraesthesia	FLU3~SANOFI PASTEUR~U0708AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0180644	01/29/2002	AZ	73.0	73		F	12/05/2001	The client states that she received Pneumovax vaccine on 12/04/01 at approx. 14:30. She states that the swelling began at approx. 18:00 on 12/04/01 and has gotten progressively worse. Her right upper arm is reddened, markedly swollen, warm and tender to touch. The client denies itching at this time but states it was itching last night. She has used Cortaid cream and ice packs with minimal relief.				Y					Y	12/04/2001	12/04/2001	0		PUB	UNK		NONE			AZ0205	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~UO696AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0094L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0180645	01/29/2002	MT	51.0	51		F	01/21/2002	Pt very poor historian. Had to wait for ER record to complete form. Tongue swelled, started itching and legs swelled. Went to ER at 14:10 on Sunday. Told ER doctor the same thing she told me; that eggs bothered her ulcer and sometimes made her nauseated. No hives or itching or anything. The doctor Rx'd as allergy with Zantac, Medrol Dose Pack and Benadryl 50mg tid. To follow-up with regular MD the next day.				Y					Y	12/07/2001	12/09/2001	2	BP 117/70	PUB	PUB	Ativan prn; Celexa; Tagamet; Prevacid; Valium prn; Flexeril prn; Lortab prn; ? Combi Patch	NONE	Migraines; Asthma; Depression; GERD; Multiple injuries		MT0203	1						1	Hypersensitivity; Oedema peripheral; Pruritus; Tongue oedema	FLU3~PFIZER\WYETH~4018052~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0180646	01/29/2002	MI	21.0	21		F	01/23/2002	30 minutes, post vax, the pt had tingling in arm. No pain or swelling. PE-nml.									U	01/22/2002	01/22/2002	0	NONE	PVT	PVT	NONE	NONE	Allergy to penicillin			1						1	Paraesthesia	FLU3~SANOFI PASTEUR~U0668AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~CONNAUGHT LABORATORIES~UB056AB~1~SC~RA~MENINGOCOCCAL (MENOMUNE)~1	USA		Influenza
0180648	01/29/2002	VA	37.0	37		F	01/22/2002	Employee received  vaccine on 10/22/2001. She went to the ER dept on 10/23/2001 with shortness of breath-dexcribed as anaphylactic reaction. Given IV pepcid, epinephrine and breathing treatment.				Y					Y	10/22/2001	10/23/2001	1	NONE	PVT	PVT	Vioxx, Paxil	NONE	codeine-Lortab			1						1	Anaphylactic reaction; Dyspnoea	FLU3~SANOFI PASTEUR~U0596BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0180649	01/29/2002	WA	84.0	84		F	12/27/2001	The pt complained of fever, diarrhea, and vomiting for 2-3 days after the second injection (first injection not verified).									Y	12/10/2001	12/11/2001	1	NONE	PVT	PVT		Diabetic	NONE			1						1	Diarrhoea; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~4018060~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0180651	01/29/2002	ME	44.0	43		F	12/15/2001	12-14 hours post flu vaccination, pt noted tenderness at injection site.										12/13/2001	12/13/2001	0	NONE	PUB	UNK	Synthroid	NONE	Latex, hypothyrocdism			1						1	Injection site hypersensitivity	FLU3~SANOFI PASTEUR~U0712AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180652	01/29/2002	ME	29.0	29		F	12/19/2001	Approx. 1 hour post vaccination, employee presented with hives on her chest and redness, soreness at injection site at the right deltoid.									Y	12/05/2001	12/05/2001	0	NONE	PUB	PVT	Elmiron	NONE	Latex, keplex, Sulfa, Cipro, PCN	11/07/2001~Hep B (Recombivax HB)~1~29.00~In Patient		1						1	Erythema; Injection site hypersensitivity; Urticaria	FLU3~SANOFI PASTEUR~U0712AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180655	01/29/2002	MI	72.0	72		F		Pt. complained of sore arm from the flu shot and had 2 red spots. Spoke with her on 01/17/2002 and the symptoms were resolved.									Y	11/12/2001	11/12/2001	0	NONE	OTH	PVT		NONe				1						1	Injection site erythema; Injection site pain; Erythema; Pain	FLU3~SANOFI PASTEUR~U0703AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0180660	01/29/2002	FL	31.0	32		F	01/24/2002	Employee experienced swelling and redness of upper extremities about one hour after flu shot administration. epinephrine 1:1000subq .5mg given and was transported to the doctor's office.				Y					Y	12/05/2001	12/05/2001	0	NONE	OTH	PUB	NONE	NONE	NONE			1						1	Injection site erythema; Injection site swelling	FLU3~EVANS VACCINES~E12461MA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0180662	01/29/2002	PA	59.0	59		F	12/11/2001	Approx. 4 hours after vaccine, right arm started to ache. By 8:30 pm, she was unable to move her right arm. Movement of the arm got extremely painful to move from 12/07/01 pm thru 12/09/01. No treatment.									Y	12/07/2001	12/07/2001	0	NONe	PUB	UNK	Aciphex, Singulair, Advair, Xanax, Anacin	NONE	Environmental Asthma, GURD		PA0201	1						1	Hypokinesia; Pain	FLU3~PFIZER\WYETH~4018029~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~474936~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0180663	01/29/2002	AK	46.0	46		F	11/15/2001	Swelling, pain and redness at right arm continued on for less than 2 weeks. Swelling of cervical lymphnodes, fever and muscle aches. Symptom onset day of injection also with ear aches, throat pain, dry cough and chest pain related to coughing.									U	11/02/2001	11/02/2001	0		PUB	PUB	Anti-hypertension	NONE	hypertension		AK200202	1						1	Chest pain; Cough; Ear pain; Erythema; Myalgia; Pain; Pharyngolaryngeal pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U0680AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0994L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0180664	01/29/2002	TX	61.0	59		F	01/07/2002	Client had a bad taste in mouth and became nauseated, vomited; severe lower back pain in less than 2 minutes following the shot. The doctor examined her medication were administered.				Y					Y	12/13/2001	12/13/2001	0	NONE	PVT	PUB	Benadryl, Decadron, Depo medrol	NONE	NONE		02009	1						1	Back pain; Dysgeusia; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U0684AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~469133~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0180687	01/29/2002	MN	27.0	27		F		Swelling, low-grade fever, induration, hot to touch, red and itching.				Y					Y	12/08/2001	12/09/2001	1		MIL	MIL	BCP's					1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~U06755AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TTOX~SANOFI PASTEUR~U0539AA~4~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0180692	01/29/2002	NM	68.0	68		F	01/24/2002	Pneumovax .5ml IM in right hip given on 1/22/02 at approx. 11:00. Had a raised area at the site. Pt began to complain of pain in the evening of 1/22/02. She saw MD at 13:30 on 1/23/02 and by the evening of 1/23/02, the area had increased. She was started on Keflex 500mg and is to see MD on 1/24/02.				Y					U	01/22/2002	01/22/2002	0		PVT	PVT		NONE	NONE			1						1	Injection site induration; Injection site pain	FLU3~SANOFI PASTEUR~U0697AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1351L~2~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0180706	01/30/2002	TN	18.0	18		M	01/24/2002	1 week after flu shot the pt had complaints of severe pain in both legs and feet. Also started to have painful nodules on legs and bottom of feet. Had flu shot for the last 2 years; administered by another co. Presently on valium, prednisone and pain med. Pt was hospitalized for 4 days from another facility. Annual follow up states pt had painful nodules that developed on his legs. Took 2 months to go away. He did not take a flu shot in 2002					Y	4		Y	U	11/20/2001	11/27/2001	7	Many blood tests; hospitalized 4 days; HIV test; Mono; Lupus; MS; STD; Leukemia and Biopsy of nodules-all neg	OTH	PVT	NONE	NONE	NONE			1						1	Pain; Skin nodule	FLU3~EVANS VACCINES~E11931LA~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0180708	01/30/2002	CA	43.0	43		M	01/24/2002	Sudden onset edema of uvula 12 hours post injection				Y					Y	01/22/2002	01/23/2002	1	NONE	PVT	OTH	NONE	NONE	allergic rhinitis off antihistamines			1						1	Tongue oedema	FLU3~PFIZER\WYETH~E119412A~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0180714	01/30/2002	MI	74.0	74		F	01/14/2002	Large red spot below injection site. Itchy redness spread almost to elbow and under arms. Not swollen. client applied ice all day. On 10-25-01, symptoms decreased, then on 10-26-01, most symptoms resolved.									Y	10/22/2001	10/24/2001	2	NONE	PUB	PVT		NONE	NONE			1						1	Erythema; Injection site erythema; Pruritus; Injection site erythema; Pruritus	FLU3~SANOFI PASTEUR~U0685AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1449K~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~637345/1449K~UNK~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0180720	01/30/2002	MO	17.0	17		F	01/24/2002	client describes red rash @ injection site with 2 days after vaccination then indentation (muscle atrophy) noted to left deltoid									Y	10/26/2001	10/28/2001	2		PVT	PUB		NONE	NONE		MO2002003	1						1	Injection site erythema; Injection site rash; Muscle atrophy; Injection site erythema; Injection site rash; Muscle atrophy	FLU3~SANOFI PASTEUR~U0574AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0574AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0180758	01/31/2002	OH	40.0			F	01/21/2002	influenza vaccine administered. patient experienced itching, hives and throat tightening.										11/06/2001	11/06/2001	0		UNK	UNK						1						1	Pruritus; Throat tightness; Urticaria	FLU3~SANOFI PASTEUR~U0676AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180759	01/31/2002	CA	58.0			M	01/23/2002	Drug interaction: Hypoprothrombinemia. Pt had received influenza vaccine 1 week earlier; INR was therapeutic before influenza vaccine. DX: elevated prothrombin time due to flu vaccine administration (probable). Treatment: Warfarin hold until INR decreased. Diagnosed with interaction between warfarin and influenza vaccine.					Y				U		10/15/2001		INR-increased	UNK	UNK			CVA; HTN; Hypercholesterolemia stabilized on long term Warfarin therapy for RUE DVT.			1						1	Prothrombin level increased	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0180760	01/31/2002	FL	73.0	66		M	12/27/2001	Taken to the hospital and admitted due to low blood sugar (40's) and felt ill. He was released the next morning.					Y	1			Y	12/06/2001	12/06/2001	0		UNK	UNK	NONE	NONE	NONE			1						1	Blood glucose decreased; Malaise	FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1050L~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0180762	01/31/2002	MD	22.0	22		M	01/08/2002	red, welts on chest, back, abdomen, arms too beginning 02/16/2001. Treated with OTC Benadryl. Cleared up on 12/17/2002									Y	12/12/2001	12/16/2001	4	NONE done	MIL	MIL	NONE		WEIGHT-147 lbs.; Height-72, BP: 122/75; Pulse 68			1						1	Erythema; Urticaria	FLU3~SANOFI PASTEUR~U0708AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0712L~2~IM~RA~HEP A (VAQTA)~1	USA		Influenza
0180784	02/01/2002	NY	71.0	71		M	01/25/2002	At 24 hours pt felt lethargic, dizzy. After dinner that night he was sweating, burping. At 48 hours pt had pain in left arm, congestion and tightness in chest. COD as per death certificate -- cardiorespiratory arrest	Y	12/28/2001							N	12/26/2001	12/28/2001	2	Last cholesterol was 225.	PVT	PVT	Atenolol; Synthroid	NONE	Chronic controlled hypertension; hypothyroidism; allergic to PCN			1						1	Apnoea; Cardiac arrest; Chest discomfort; Dizziness; Eructation; Hypercholesterolaemia; Hyperhidrosis; Lethargy; Nasal congestion; Pain	FLU3~PFIZER\WYETH~4018029~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0180786	02/01/2002	CA	60.0	59		M		Within 24 hours post vaccination, the pt developed hives, weakness, paleness, body aches, rapid heart beat, dizziness, nausea, some difficulty breathing, extreme headache and vision distortion.			Y	Y					Y	11/12/2000	11/13/2000	1	NONE	MIL	OTH	UNK	NONE	UNK			1						1	Asthenia; Dizziness; Dyspnoea; Headache; Heart rate increased; Nausea; Pain; Urticaria; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0180787	02/01/2002	MA	52.0	60		F	01/28/2002	Developed hives above injection site within 10 minutes, post vax. It spread to shoulders, neck and scalp within 30 minutes. Treated with Cortisone creme locally; Benadryl 50mg q 6-8 hours X 36 hours. Persistent scalp itching X several weeks. It is still itching.									Y	11/26/2001	11/26/2001	0	NONE	OTH	OTH	Prilosec; Salagsa levlite; BC pill	NONE	Allergy to Bactrim and various (mild response) to foods in the past	Fever and pain at injection site~DTP (no brand name)~~7.00~In Patient		1						1	Pruritus; Urticaria	FLU3~EVANS VACCINES~~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0180819	02/04/2002	PA	31.0	31		F	03/30/2000	It was reported that a 31 year old female pt received a TD Adult and a Fluzone UNSP '99-'00 vaccination on 3/20/00. Reportedly, on 3/21/00, the pt complained of redness, itching, soreness, warmth to touch and an induration of the left deltoid. From correspondence received on 3/29/00, it was reported that the pt recovered from this experience.									Y	03/20/2000	03/21/2000	1		UNK	UNK					U200000160	1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site warmth; Pruritus	FLU3~CONNAUGHT LABORATORIES~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0180847	02/04/2002	NH	74.0	74		F	01/28/2002	Progressive generalized weakness which began approx 7-10 days after administration of influenza vaccine. (Guillain Barre).					Y	60			N	10/25/2001	11/03/2001	9	CSF-increased protein; WBC-nml	PVT	UNK		CAD, CHF, DM,HTN, thrombocytosis	Allergy to PCN			1						1	Asthenia; CSF test abnormal; Guillain-Barre syndrome	FLU3~SANOFI PASTEUR~U0669AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0180849	02/04/2002	IL	67.0	66		F	01/10/2002	The pt received a flu vaccine on 10/17/01. She had no problems until around Thanksgiving, at which time, she was dx'd with pneumonia and bronchitis. Shortly after this, she began experiencing a feeling of numbness in her feet, hips, arms, face and mouth. She told her doctor about these symptoms and was hospitalized in order to figure out what was going on. Her doctor could not find anything wrong. Even though she was discharged from the hospital, she continued to have problems. At this time, the pt's daughter took her to see another doctor and according to her daughter, the dx was confirmed as Guillain-Barre after obtaining the results of a spinal tap. The pt is currently recovering in the home of her daughter.			Y	Y	Y				Y	10/17/2001			Spinal Tap - Guillain Barre	OTH	OTH						1						1	Bronchitis; Guillain-Barre syndrome; Hypoaesthesia; Pneumonia	FLU3~SANOFI PASTEUR~U0672AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0180850	02/04/2002	NY	81.0	81		F	10/29/2001	Shot Thursday, sluggish on Friday, vomited on Saturday, Monday weak, rundown, no fever.									Y	10/25/2001	10/27/2001	2	NONE	OTH	PVT		NONE	NONE			1						1	Asthenia; Sluggishness; Vomiting	FLU3~SANOFI PASTEUR~U0559BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1456K~2~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0180851	02/04/2002	NY	87.0	87		M	11/20/2001	The pt had a fever of 102 degrees F. Took extra strength tylenol. Gait unsteady so he was taken to the ER which they gave him more tylenol and some fluids. Temp went down to 99 degrees and then he was released.									Y	11/10/2001	11/10/2001	0	Blood work	OTH	PVT	Carbasoleyegtts, zypryxa for sleep	NONE	NONE			1						1	Gait disturbance; Pyrexia	FLU3~SANOFI PASTEUR~U0682AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180852	02/04/2002	MA	68.0	68		F	01/14/2002	The pt had a reaction to pneumococcal vaccine. Left arm got red, hot and swollen for five days.									Y	11/27/2001	11/28/2001	1	NONE	PUB	PUB		NONE	NONE		0201	1						1	Erythema; Feeling hot; Swelling	FLU3~SANOFI PASTEUR~U0676AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0923L~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0180853	02/04/2002	NY	71.0	71		F	10/24/2001	Faint for 1 hour by noon feeling fine.									Y	10/22/2001	10/23/2001	1	NONE	OTH	PVT	Benadryl	Allergies to trees and flowers		~Influenza (Seasonal) (no brand name)~1~50.00~In Patient		1						1	Syncope	FLU3~SANOFI PASTEUR~U0682AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180854	02/04/2002	NY	62.0	62		F	10/29/2001	Late Tuesday stomach cramps, vomited, sweats along with vomiting. On 10/23/2001 Wednesday sipped water, tea, ate little in the evening and had no problems.									Y	10/21/2001	10/23/2001	2	NONE	OTH	PVT	Fisomax	NONE	Penicillin Allergy			1						1	Abdominal pain upper; Hyperhidrosis; Vomiting	FLU3~SANOFI PASTEUR~u0599BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180855	02/04/2002	NY	47.0	48		F	10/24/2001	Monday-soreness, put on ice pack, achiness on arm, weakened. Tuesday, wiped out chest aching, nausea, loss of appetite.									Y	10/21/2001	10/22/2001	1	NONE	OTH	PVT	Vitamins, Melatonin	NONE	Arhythemia, no meds			1						1	Anorexia; Chest pain; Muscular weakness; Myalgia; Nausea; Pain	FLU3~SANOFI PASTEUR~U0599BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1456K~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0180856	02/04/2002	NY	38.0	38		F	10/17/2001	Arm red and swollen, felt lump at injection site. Went to see the doctor the next day (10/15/2001) and was prescribed Alegra, took it twice only because it made her drowsy.									Y	10/14/2001	10/15/2001	1	NONE	OTH	PVT	Vitamins, Elavil QN	NONE	Migranes			1						1	Injection site mass; Oedema peripheral	FLU3~SANOFI PASTEUR~U0703AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180857	02/04/2002	NY	74.0	74		F	10/19/2001	Flu shot on 10/10/2001. Went to the doctor's on the 14th for fever, vomiting, aches and pains. The doctor said that it's the virus, no Rx, but did blood work.									Y	10/10/2001	10/14/2001	4	Blood work-iver enzymes up, digoxin lever up	OTH	PVT	Toprol xl 100mg, BabyASA gD/Betapet, Diyoxin	NONE	High cholesterol, elevated BP, heart condition			1						1	Pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U0599BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~146K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0180859	02/04/2002	MI	62.0	62		F	02/01/2002	Lesion on back, swollen for 2 and a half months, chills everyday up to now, extreme rash, itching, difficulty breathing, vomiting, diarrhea.				Y					N	10/31/2001	11/01/2001	1		OTH	OTH						1						1	Chills; Diarrhoea; Dyspnoea; Pruritus; Rash; Skin ulcer; Swelling; Vomiting; Injection site reaction; Injection site swelling; Rash; Chills; Diarrhoea; Dyspnoea; Injection site reaction; Pruritus; Rash; Vomiting	FLU3~SANOFI PASTEUR~U0575AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0575AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~UO575AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Emergency room visit	Influenza
0180867	02/04/2002	TX	0.17			F	02/01/2002	Very hyper and agitated the day after vaccination. Four days later she started crying and crying until no apparent reason which she never used to do that before.									Y					OTH	OTH						1						1	Agitation; Crying; Psychomotor hyperactivity	DTAP~UNKNOWN MANUFACTURER~~UNK~~~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1	USA		Influenza
0180900	02/05/2002	MI	47.0	54		F	01/28/2002	Pt stated her arm bruised after receiving flu vaccine. was instructed to apply ice.									Y	10/25/2001	10/26/2001	1	NONE	PUB	PVT		NONE	NONE			1						1	Contusion; Contusion	FLU3~SANOFI PASTEUR~V0575AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0575AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0180901	02/05/2002	MI	42.0	42		F	01/28/2002	Pt stated she got sick after receiving flu vaccine. had fever of 100 degrees F. No arm soreness. Client stayed home and rested. Symptoms resolved.									Y	11/03/2001	11/05/2001	2	NONE	PUB	PVT		NONE	NONE			1						1	Pyrexia; Malaise; Pyrexia	FLU3~SANOFI PASTEUR~U0685AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0685AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0180902	02/05/2002	MI	24.0	24		F	01/20/2002	client sick all day', had emesis X 2 swollen area @ injection site, did not apply ice, On 11-5-01, no fever, but still swollen arm, was advised to see MD if not better									Y	11/03/2001	11/03/2001	0	NONE	PUB	PVT		NONE	NONE			1						1	Injection site oedema; Vomiting; Injection site swelling; Malaise; Vomiting	FLU3~SANOFI PASTEUR~U0685AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0685AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0180903	02/05/2002	MI	49.0	49		F	01/28/2002	Client c/o soreness at the injection site. was instructed to apply ice and take Tylenol. symptoms resolved.									Y	10/31/2001	11/02/2001	2	NONE	PUB	PVT		NONE	NONE			1						1	Injection site pain; Injection site reaction	FLU3~SANOFI PASTEUR~U0685AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0385AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0180904	02/05/2002	MI	55.0	55		F	01/28/2002	client c/o bruise on arm, hot to touch and itchy. instructed to aooly ice and take tylenol. Symptoms resolved.									Y	11/03/2001	11/06/2001	3	NONE	PUB	PVT		NONE	NONE			1						1	Contusion; Feeling hot; Pruritus; Contusion; Feeling hot; Pruritus	FLU3~SANOFI PASTEUR~U0685AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0685AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0180905	02/05/2002	MI	85.0	85		F	01/28/2002	Client c/o discoloration at injection site. On 11-12-01, client stated color was better and doing ok.									Y	10/31/2001	11/09/2001	9	NONE	PUB	PVT		NONE	NONE			1						1	Injection site reaction; Skin discolouration; Injection site reaction; Skin discolouration	FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0180906	02/05/2002	MI	34.0	34		F	01/28/2002	Client had reddened, itchy, puffy and nickel sized area on left cheek one hour after immunization. was given ice pack and instructed to call MD if any concerns. On 11-12-01, symptoms resolved.									Y	11/06/2001	11/06/2001	0	NONE	PUB	PVT		NONE	Pregnant			1						1	Erythema; Pruritus; Swelling face; Face oedema; Pruritus; Rash	FLU3~SANOFI PASTEUR~0685AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~0685AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0180907	02/05/2002	MI	38.0	38		F	01/28/2002	Client c/o red rash with itching (generalized) after 7 minutes of injection. She was given Benadryl 50mg IM. After 3 hrs. of observation, client was ok.									Y	11/13/2001	11/13/2001	0	NONE	PUB	PVT		NONE	NONE			1						1	Pruritus; Rash erythematous; Erythema; Pruritus; Rash	FLU3~SANOFI PASTEUR~U0703AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0703AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0180908	02/05/2002	MI	47.0	47		F	01/28/2002	Client c/o sore arm and sore neck. On 12-17-01, symptoms resolved and client felt sore neck was due to a bug.									Y	12/07/2001	12/11/2001	4	NONE	PUB	PVT		NONE	NONE			1						1	Myalgia; Pain	FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0180909	02/05/2002	MI	59.0	59		M	01/28/2002	Client c/o shoulder hurting and not being able to move aem, i.e lift without aches. Arm never red or swollen, was advised to see MD									Y	10/24/2001	11/29/2001	36	NONE	PUB	PVT		NONE	NONE			1						1	Joint range of motion decreased; Pain; Joint range of motion decreased; Pain; Shoulder pain	FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0180910	02/05/2002	MI	28.0	28		F	01/28/2001	Client c/o redness, swelling and itchy at the site of injection was instructed to apply ice. On 12-3-01, symptoms resolved.									Y	11/16/2001	11/19/2001	3	NONE	PUB	PVT		NONE	NONE			1						1	Injection site erythema; Injection site hypersensitivity; Injection site oedema; Pruritus; Injection site erythema; Injection site reaction; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U0703AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~UO703AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0180911	02/05/2002	MI	11.0	11		M	01/28/2002	Client c/o some itching a few minutes after shot. no redness, ice was applied to site and that stopped itching. On 11-06-01, arm was little sore , but still some soreness.									Y	11/05/2001	11/05/2001	0	NONE	PUB	PVT		NONE	NONE			1						1	Pruritus; Injection site hypersensitivity; Pruritus	FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0180912	02/05/2002	MI	69.0	69		M	01/28/2002	Client c/o vomiting 2 days after shot. On 11-15-01, symptoms resolved. Client felt vomiting was not associated with vaccine.									Y	11/05/2001	11/07/2001	2	NONE	PUB	PVT		NONE	NONE			1						1	Vomiting; Vomiting	FLU3~SANOFI PASTEUR~U0685AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0685AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0180914	02/05/2002	CA	74.0	74		M	01/22/2002	12/6/01 numbness of soles of feet and palms of hands. Weakness of legs and knees. 12/11 continuance of above; excruciating pain in shoulders, neck, upper arms. This was an extreme situation until second week in January. symptoms persist but milder				Y					N	12/05/2001	12/06/2001	1	blood tests, including those for muscle involvement	PUB	UNK	Trazodone-50 mg; Lisinopril-10 mg, Lostatin- 10 mg	cold	slight stroke-10/99; Prostate cancer (radiation 6/8/01)			1						1	Hypoaesthesia; Muscular weakness; Myalgia	FLU3~PFIZER\WYETH~4018042~4~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0180915	02/05/2002	WY	70.0	70		M		Violent vomiting, extreme headache, uncontrollable rise in  blood pressure-EKG cause for alarm. Emergency room in Lander, Wyoming gave medication for vomiting and headache but it didn't help. The cardiologist in Casper spent 7 hours trying to relieve the problem w/ many tests. Finally consulted a neurologist who put him on a seizure medication which he is still on, still has headaches without medications.Neurologists diagnosed a type of meningitis				Y					N	12/05/2001	12/05/2001	0		PUB	PVT	Procardia, Comadin		Polycythemia, high blood pressure	headache and vomiting~Influenza (Seasonal) (no brand name)~~68.00~In Patient		1						1	Dyskinesia; Headache; Meningitis; Vomiting	FLU3~PFIZER\WYETH~4018029~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0180916	02/05/2002	MS	40.0	40		F	01/26/2002	Approximately 2 am on 01-26-02, pt reported swelling, redness and heat at injection site. also reported large knot at injection site, c/o pain from shoulder to fingers and difficulty moving arm, these symptoms involved (R) arm. pt saw ER physician 1-28-2 and prescibed keflex due to infection at injection site, saw PMD 1-30-02 and advised no more pneumonia shots.				Y					Y	01/25/2002	01/26/2002	1		PUB	PUB			diagnosed with diabetes approximately 1 month ago		MS02004	1						1	Injection site erythema; Injection site infection; Injection site mass; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U0698AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0180918	02/05/2002	MI	67.0	67		F	12/17/2001	12/17/01 TC from Re; mother, states mother received flu shot on 11/30/2001. On the evening of 11/30 began symptoms of severe HA, nausea, vomiting temperature and extreme fatigue, was in bed all 12/1 and 12/2/01-felt better but tired and on 12/16 developed symptoms again severe HA, nausea, chills. Scheduled a physician appointment to have mother evaluated. 01/15/02 client stated went to ER x 1, diagnosis virus, saw another physician, diagnosis sinus infection, placed on Bactrim and nasal spray. He developed chest pain seeing cardiologist for a work-up.				Y					Y	11/30/2001	11/30/2001	0		PUB	UNK	history rheumatoid Arthritis, takes Tylenol 3 prn	NONE	Allergic to Penicillin		MI2002002	1						1	Fatigue; Headache; Nausea; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~4618045~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0180936	02/05/2002	MI	52.0	52		M	12/28/2001	Had flu shot last week (not sure) and complained of sore throat and rash 3-4 days after shot, mostly behind knees and on elbows. Referred to PP and given resources.									U	12/21/2001	12/26/2001	5		PUB	PUB	UNK				MI2002005	1						1	Pharyngolaryngeal pain; Rash	FLU3~PFIZER\WYETH~4018053~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0180958	02/06/2002	WA	7.0	6		M	12/05/2001	The pt developed itchy (hives) rash on face and spreading to knees and arms following day after the flu shot was given on 11/14/2002.				Y					Y	11/13/2001	11/14/2001	1		PVT	PUB	Insulin, humaloy+NPH	NONE	Type I Diabetes			1						1	Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U0588AA~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0180959	02/06/2002	WA	16.0	16		F	12/05/2001	Flu vaccine given at 6pm on 11/30/2001. She developed shakiness and chills, pain both legs along with tingliness which lasted for 4 hours. Symptoms went away on 12/01/2001 am.									Y	11/13/2001	12/01/2001	18	NONE	PVT	PUB		NONE	NONE			1						1	Chills; Pain; Paraesthesia; Tremor	FLU3~SANOFI PASTEUR~U0588AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180960	02/06/2002	IL	42.0	41		F	01/31/2002	The day after receiving the flu vaccine, the employee complained of tingling and numbness in left arm. Still has slight tingling.									N	11/20/2001	11/21/2001	1		PVT	PVT						1						1	Hypoaesthesia; Paraesthesia	FLU3~SANOFI PASTEUR~U0671BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180961	02/06/2002	IL	48.0	48		M	01/31/2002	Employee complained of weakness, tingling in left arm. Symptoms began soon after employee received the flu vaccine.									N	11/29/2001	12/04/2001	5	Nerve conductions studies done. Results showed slowing of ulnar nerve above the elbow.	PVT	PVT		NONE	NONE			1						1	Asthenia; Conduction disorder; Paraesthesia	FLU3~SANOFI PASTEUR~U0671BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0180962	02/06/2002	CA	74.0	74		F		Headaches, dizzy, high blood pressure, upset stomach for 10 days.									Y	10/31/2001	11/02/2001	2		PVT	OTH	Asprin, Hydrotin, Pepcid, Allegra, KLOR-25, Atanenol	NONE	Sinus, HBP, Hypertension, Arthritis			1						1	Dizziness; Headache; Hypertension; Stomach discomfort	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0180544	02/07/2002	IA	44.0	44		F	01/14/2002	Injection  in left deltoid on 10/8/01. Injection was immediately painful and deltoid area swelled. Now has decreased ROM; arm can't swing toward back or twist to hook bra or buckle seat belt; pain in neck and can't reach arm above head. It is painful at night and aches all the time. Laying down causes increased pain. Dx'd with bursitis and given Vioxx with no relief. Taking physical therapy from November to January 2-3 X a week. To see muscle therapist or orthopedic doctor. Sees physical therapist X 3 months with no relief.				Y					N	10/08/2001	10/08/2001	0		PUB	PUB	NONE	NONE	Mitral Valve Prolapse			1						2	Hypokinesia; Injection site oedema; Injection site pain; Muscular weakness; Pain; Bursitis; Injection site pain; Injection site swelling; Joint range of motion decreased; Neck pain; Bursitis; Hypokinesia; Injection site reaction; Muscular weakness; Myalgia; Tendonitis; Injection site reaction; Injection site swelling; Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~4	USA	Emergency room visit	Influenza
0180859	02/07/2002	MI	62.0	62		F	02/01/2002	Local reaction to entire upper arm. Swollen X 2 days. Rash over trunk and arms, off and on, for months (since receiving vaccine). States the clinic stated allergic reaction to vaccine.				Y					Y	10/31/2001	11/01/2001	1		PVT	PVT		NONE				1						2	Chills; Diarrhoea; Dyspnoea; Pruritus; Rash; Skin ulcer; Swelling; Vomiting; Injection site reaction; Injection site swelling; Rash; Chills; Diarrhoea; Dyspnoea; Injection site reaction; Pruritus; Rash; Vomiting	FLU3~SANOFI PASTEUR~U0575AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0575AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~UO575AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Emergency room visit	Influenza
0181022	02/07/2002	NJ	41.0	41		F	02/05/2002	A 41 year old female reported that she received Flu Shield ('00-'01) on 11/28/00. On that day, she reported being approx. 2 weeks pregnant. Follow-up information has been received on 2/1/02 from the now 42 year old female who reported that she had a miscarriage. The date of the event was not reported. The event was considered to be an Other Important Medical Event.									Y	11/28/2000			UNK	OTH	OTH	NONE	UNK	UNK		5538604	1						1	Abortion spontaneous	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181027	02/07/2002	LA	52.0	52		F	01/29/2002	I feel that it was encephalopathy. I had a 2 degree increase in temperature, was confused, forgetful, felt hot and dry, sensitive to light, weak, muscle aches and blurred vision. My head felt full like my brain was swollen. These lasted 1 week. I had sinusitis 11 days after onset and I still have rhinitis. Per doc 213152, patient temp is 97o,+ for a week, then was 99o from 12/17/2001 to 12/24/2001. Then was above normal for another month. Patient got a nasal infection. Report also states that encephalopathy occurred 5 days after the flu injection. Patient also has dry nose which cause bleeding.			Y						N	12/12/2001	12/17/2001	5		PUB	OTH	Serzone 25mg per day	NONE	Depression	Mild reaction~Influenza (Seasonal) (no brand name)~1~49.00~In Patient		1						1	Asthenia; Confusional state; Encephalopathy; Hot flush; Memory impairment; Myalgia; Photophobia; Pyrexia; Rhinitis; Sinusitis; Vision blurred	FLU3~SANOFI PASTEUR~U0698AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0181033	02/07/2002	WI	45.0	45		M	12/05/2001	The pt developed a confluent red and itchy rash with swelling on the anterior surface of both arms and both legs. The reaction started approx. 6-8 hours, post vax. The night after the vaccine, he had chills.									Y	11/27/2001	11/27/2001	0	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Chills; Erythema; Hypersensitivity; Pruritus; Rash; Swelling	FLU3~SANOFI PASTEUR~U0707AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0181060	02/07/2002	MI	71.0	71		M	01/29/2002	Fever, hot/cold sweats, rapid pulse, headache. Severe reaction to flu vaccine, i.e. jerking movements, spasms over entire body, head, shoulder chest, arm, hands, hips, thighs, knees, calves, ankles, feet and elbows. Still continuing but less present since flu shot on 12/31/2001.									N	12/31/2001	12/31/2001	0		PVT	UNK	Tussionex EXT-RE1, Susmede Cough Syrup	Severe Coughing; Bronchitis	NONE			1						1	Dyskinesia; Headache; Heart rate increased; Hyperhidrosis; Muscle spasms; Pyrexia	FLU3~SANOFI PASTEUR~U0685AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0181087	02/07/2002	NY	26.0	26		F	01/29/2002	30 mins post injection the pt developed chest pain, shortness of breath. Pt later developed nausea and emesis x2 with itching but no hives. Prescribed atara, pepcid, benadryl, pred.				Y					Y	01/07/2002	01/07/2002	0	NONE	PVT	PVT	proventil, HFA, MDI, allegra, zithromax	asthma, sinusitis, otitis media	asthma, anxiety, allergy			1						1	Chest pain; Dyspnoea; Haematemesis; Nausea	FLU3~PFIZER\WYETH~4018126~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0181101	02/08/2002	NC	53.0	53		F	02/02/2002	Severe pain in left arm, 1 hour, post vax. Conditioned worsened until arm was unusable. Could not raise arm. Arm throbbed with pain. Blood vessel burst on inside of elbow. Went to ER, 2 days before Thanksgiving. Had to wear a sling on arm for 10 days. Arm is better but soreness not completely gone.				Y					U	10/17/2001	10/17/2001	0		PVT	PVT	Synthroid		Hypothyroidism			1						1	Haemorrhage; Hypokinesia; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0181107	02/08/2002	MN	66.0	66		F	12/19/2001	Pt had an apparent seizure and was taken to ER. All tests were negative and pt was discharged after 2 hours of observation. No fever.				Y					Y	12/13/2001	12/14/2001	1	CBC; EKG; Chem 8; Head CT	OTH	UNK	Aricept	NONE	Alzheimer's Dementia			1						1	Convulsion	FLU3~PFIZER\WYETH~4018046~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0180544	02/11/2002	IA	44.0	44		F	08/19/2002	From coresondence recieved on 01/29/2002, it was reported that a 44 year old female pt received a fluzone vaccination administered IM-left deltoid on 10/08/2001. The injection was immediately painful and deltoid area swelled. Pt now has decreased range of motion, arm can't swing toward back or twist to hook bra or buckle seat belt. Arm is weak, can't reach arm above head. Painful at night aches all the time. Lying down increases the pain. Diagnosis Bursitis, given Vioxx for treatment with no relief. Taking physical therapy exercises from November to January 2, 3 times a week. To see therapist or orthopedic out patient. On 01/24/2002, she was diagnosed with tendonitis and bursitis. Given Methel-pred dose pack to take for 6 days starting 01/25/2002. Given Vioxx 25mg for 30 days. From faxed correspondence received on 4/23/02, pt reported that she was seen by orthopedic surgeon on 2/25/02. X-ray were taken of the left shoulder/arm area and no damage noted to the muscle. MD suggested that she continue on an additional 30 day regimen of Vioxx 25mg 1 QD for pain/inflammation as she is responding to Vioxx. Pt was instructed to stretch left arm in front of her chest and hold for one minute, then put left arm in back and try to pull up toward shoulder baldes and hold for one minute twice daily to stretch out the shoulder. Instructed to follow up with the doctor in four weeks (3/25/02) if condition did not change. From follow up received on 8/12/02 it was reported finished Vioxx dose, did recomend exercises. Pain subsided mid-April 2002. Reveiwed, no addtional information at this time. Case closed.				Y					Y	10/08/2001	10/08/2001	0	Seen physical therapist for 3 months-no relief	PUB	PUB		NONE	Mitral valve prolapse.		U200200093	1						3	Hypokinesia; Injection site oedema; Injection site pain; Muscular weakness; Pain; Bursitis; Injection site pain; Injection site swelling; Joint range of motion decreased; Neck pain; Bursitis; Hypokinesia; Injection site reaction; Muscular weakness; Myalgia; Tendonitis; Injection site reaction; Injection site swelling; Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~4	USA	Emergency room visit	Influenza
0181129	02/11/2002	MI	65.0	65		F	02/06/2002	It was reported by the pt that she received a Fluzone SV '01-'02 vaccination in her left deltoid on 11/7/01. A week later, on 11/15/01, she broke out in generalized hives, bad enough to go to the ER on 11/16/01. She was given a Depro-Medrol injection and has been on Prednisone, 4 courses since. She gets eye swelling, skin peeling on her ears, itchiness and ear infections on and off. The itchy rash appears on her neck, back, chest, under her arms and tail bone area. Her physician has reported this to the Health Dept. She states this involved 5 other pts. This was considered to be an Other Important Medical Event.				Y					U	11/07/2001	11/15/2001	8		UNK	UNK					U200200053	1						1	Ear disorder; Eye oedema; Infection; Pruritus; Skin exfoliation; Urticaria; Dermatitis; Eye discharge; Face oedema; Urticaria; Chills; Fatigue; Headache; Otitis media; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0575AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0575AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~474938~1~IM~RA~PNEUMO (PNEUMOVAX)~2|IPV~SANOFI PASTEUR~U0575AA~UNK~SC~LA~POLIO VIRUS, INACT. (POLIOVAX)~3|PPV~UNKNOWN MANUFACTURER~~1~IM~~PNEUMO (NO BRAND NAME)~3	USA	Emergency room visit	Influenza
0181131	02/11/2002					U	02/07/2002	A health care provider reported that an unidentified person received Flu Shield (2001-2002) vaccine. The pt was reported to be in a hospital bed. The pt experienced a serious reaction to Flu Shield and may die. No additional information was available as of the date of this report.					Y				U				UNK	OTH	OTH	UNK	UNK	Splenectomy; Systemic Lupus Erythematosus		HQ0555907FEB2002	1						1	Unevaluable event	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0181136	02/11/2002	LA	69.0	68		M	01/11/2002	States IZ given in late AM. He was sitting in a chair talking to someone, when his head fell to his shoulder. He became extremely dizzy and vomited X 3 and then had a hot Flash. He then perspired profusely and was not feeling well. He went to bed. He felt better in the AM.				Y					U	02/05/2001	02/05/2001	0	10/22/01-PMD visit; 10/29/01-MRI; 11/5/01 and 11/06/01-Angiogram	PUB	PUB	Baby ASA; Zyrtec; Zocor; Cotheosn; AeroBid; Verelan; Accolate; Albuterol; Indur	NONE	Severe asthma; Allergies; Heart condition; Stents		LA020201	1						1	Dizziness; Hot flush; Hyperhidrosis; Malaise; Torticollis; Vomiting	FLU3~PFIZER\WYETH~4008198~4~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0181139	02/11/2002	OH	27.0	27		M	11/09/2001	The pt developed an itchy rash that started 2 days, post vax. The rash had spread from his shoulder down his bicep and forearm.									Y	11/05/2001	11/07/2001	2	NONE	PVT	UNK		NONE	NONE			1						1	Pruritus; Rash	FLU3~EVANS VACCINES~E04851KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0181140	02/11/2002	CA	41.0	41		F	01/31/2002	On 12/4/01, the pt had pain in her right arm and injection site. On 12/17/01, she had intermittent low-grade fever and body aches X 3 weeks.									Y	12/03/2001	12/04/2001	1	SGPT-474; ANA-(+); CBC and Blood culture-nml	PVT	PVT	NONE	NONE	PCN allergy			1						1	Alanine aminotransferase increased; Antinuclear antibody positive; Injection site pain; Pain; Pyrexia	FLU3~EVANS VACCINES~E05221KA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0181184	02/11/2002	OH	22.0	22		F	03/12/2001	It was reported that a 22 year old female pt received a Menomune A/C/Y/W-135 vaccination in the left arm and a Fluzone SV '00-'01 vaccination in the right deltoid on 10/18/00. Approx. 20-25 minutes, post vax, the pt complained of swollen feeling, right side of face and tongue felt swollen. Complained of swelling of lips and nostril. Pt was evaluated by MD. The pt recovery status is unknown.				Y					U	10/18/2000	10/18/2000	0	UNK	OTH	PVT	Levlite; Claritin; Lopressor; allergy shots	Allergy shots for environmental allergies	Nuerally mediated hypotension		U200100286	1						1	Swelling face; Tongue oedema	FLU3~AVENTIS PASTEUR~U0402C~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~SANOFI PASTEUR~7188AA~UNK~SC~LA~MENINGOCOCCAL (MENOMUNE)~1	USA	Emergency room visit	Influenza
0181192	02/11/2002	NY	20.0	20		F	03/12/2001	It was reported that a 20 year old female pt received a Menomune vaccination in the right arm and a Fluzone unspecified vaccination in the left arm. Reportedly 2pm, 1/2 hour after the injections the pt developed a 2cm length x 1cm raised induration on her right arm. Pt experienced itching, no shortness of breath, no hives. Administered Benadryl 50mg per oral, cold compresses and sent to health clinic. Reportedly the pt recovered from this experience.				Y					Y	10/25/2000	10/25/2000	0		OTH	PVT	Ortho Tricycline		Allergic to sulfa and penicillin		U200100285	1						1	Injection site reaction; Pruritus	FLU3~AVENTIS PASTEUR~U0402CA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~SANOFI PASTEUR~7188AA~1~~RA~MENINGOCOCCAL (MENOMUNE)~1	USA	Emergency room visit	Influenza
0181196	02/11/2002	NJ	21.0	21		F	03/22/2001	It was reported that a 21 year old female pt received a Menomune vaccination and a fluzone vaccination both given in the left arm on 11/09/2000 at 6:17pm. Reportedly at 6:22pm, the pt developed a small area 1x1.5 inches of redness at left inner aspect elbow, not at injection site. Ice was applied for 10 mins and redness resolved. Benadryl was given. The pt reportedly recovered from this experience.									Y	11/09/2000	11/09/2000	0	NONE	OTH	OTH	Zoloft, Depakote	NONE	NONE		U200100292	1						1	Erythema; Rash	FLU3~AVENTIS PASTEUR~U0399BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~SANOFI PASTEUR~7346AA~UNK~SC~~MENINGOCOCCAL (MENOMUNE)~1	USA		Influenza
0181217	02/11/2002	NC	82.0	82		F	12/03/2001	A physician reported that an 82 year old female received an injection of Flu Shield (2001-2002 Formula) on approximately 14 Nov 2001. One week post immunization, she developed angioedema and urticaria. No further information was available as of the date of this report. Angioedema was considered medically important. FOLLOW-UP information received from the reporter on 01/15/2002 provided the Flu Shield lot number and indicated that the vaccine was administered on 10/02/2001, rather than 11/14/2001.				Y					U	11/14/2001	11/21/2001	7		OTH	OTH					HQ8977729NOV2001	1						1	Angioneurotic oedema; Urticaria	FLU3~PFIZER\WYETH~4018028~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0178044	02/12/2002	IL	27.0	27		F	01/07/2002	A nurse reported that a 27 year old female received an injection of flu shield on 11/09/2001 and the next day, experienced tenderness at her left neck base, left lateral chest wall and left upper arm. The pt was diagnosed with myositis and prescribed propoxyphene napsylate. The pt felt better the next day. The reporter spoke with the pt on 11/13/2001 and she was much better. This is 1 of 2 pts from this facility to experience an adverse event following receipt of flu shield. Additional info received on 12/20/2001 indicated that the pt recovered.				Y					Y	11/08/2001	11/09/2001	1	UNK	OTH	PVT	UNK	UNK	UNK		HQ8958929NOV2001	1						2	Myositis	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0181231	02/12/2002	FL	71.0	71		F	01/21/2002	The vaccinee was admitted to the hospital few days after the vaccine, very ill. Hospital diagnoses included fever, altered mental status					Y		Y		Y	10/10/2001				OTH	PVT	NONE	NONE	Lymphoma, chronic atrial fib			1						1	Laboratory test abnormal; Malaise; Pyrexia; Thinking abnormal	FLU3~SANOFI PASTEUR~U0681AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0181238	02/12/2002	ID	8.0	8		M	12/26/2001	12/23/01  No increase temperture, right arm red, swollen, warm to touch from shoulder to elbow, saw PMD. PMD prescibed: Allegra, Pediapred, Keflex. 12/26/01 right arm appears normal is size, decrease red in color.				Y					Y	12/21/2001	12/23/2001	2		OTH	PUB	NONE	NONE	NONE		ID02004	1						1	Feeling hot; Injection site erythema; Injection site oedema	FLUX~UNKNOWN MANUFACTURER~4018029~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0181242	02/12/2002	NC	49.0	49		F	02/06/2002	After the vaccination, the patient developed nausea, vomiting, and diarrhea with myalgias. Then she felt better then restarted even worse. Had poor appetite then felt weak for another week. She ate poorly and was back to normal about 20 days after the vaccination.									Y	01/08/2002	01/09/2002	1	NONE	PVT	PUB	Tolradex, voltaren, auphex, syntharid,Inderal, lasip, ambien, premarin	MRSA recurrent furunculosis	FCD breast, D.M., von-willie levant's Dz, M valve prologuse, hernia mesh.			1						1	Anorexia; Diarrhoea; Myalgia; Nausea; Vomiting	FLU3~EVANS VACCINES~E12461MA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0181243	02/12/2002	SC	51.0	51		M	02/02/2002	0955 given flu injection L arm (upper mid delt.) and reports after 5 min started itching and slow increased to both arms and neck after 10 mins. Pt comoplained to staff of itchying and red swelling over and neck. 50mg Beandryl given 101.5. Itching stopped 1025.									Y	02/02/2002	02/02/2002	0	NONE	MIL	MIL	NONE	NONE	Type II DM, diet controlled x 3 years.			1						1	Erythema; Oedema; Pruritus	FLU3~SANOFI PASTEUR~U0702AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0181246	02/12/2002	MI	40.0	40		F	10/22/2001	On 10/19/01 at 01:00, had severe pain in right arm. She called the doctor and he told her to take Benadryl and ibuprofen. Her arm was swollen between her elbow and her should and was red but no itching. She had red blotchy areas and was hot to touch. On 10/20/01 AM, she had increased swelling down toward her wrist and under her armpit. Her temperature was 101.4F. Nausea started and she went to ER.				Y					Y	10/18/2001	10/19/2001	1	Blood culture-neg	PUB	PUB	Multivitamins	NONE	Environmental allergies and PCN; Asthma		MI2002012	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Nausea; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U0593AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~470589~1~SC~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0181247	02/12/2002	MI	16.0	16		F	01/29/2002	Rash on bilateral arms and shoulders. Rash noticed by client on 1/5/02 around the injection site and spread across shoulders and other arm. Pt denies itching, difficulty breathing, shortness of breath or rash anywhere else on her body. PHN referred pt to PP. Follow-up call to parent on 1/10/02 finds that rash is still present but is doing fine. On 1/29/02, telephone call to parent who stated that the rash persisted until 1/21/02 (approx). The rash was never red but was raised; only on the upper body, shoulders and back primarily and somewhat itchy (but not intense). Other factors discussed; the pt had been treated and recovered from scabies but still had some lingering lesions. The pt was never taken to a doctor for care during this time. Recommended discussing this reaction with the pt's doctor and to consider checking prior to receiving future vaccines.									U	01/04/2002	01/05/2002	1	NONE	PUB	UNK	Antibacterial cream for skin infection	NONE	NONE		MI2002008	1						1	Injection site rash	FLU3~PFIZER\WYETH~4018053~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181248	02/12/2002	MI	39.0	39		F	01/02/2002	On 12/26/01 at 15:30, left arm starting feeling itchy and noticed red, warm rash. On 12/27/01, AM, started on armpit, torso and now all over body and still persisting now. No other symptoms noted. Didn't seek medical care due to no insurance and no doctor. Referral given to clinic and no MC for medical treatment. Last flu vaccine was 5 years ago. On 1/10/02, no answer for update. On 1/29/02, telephone call; no answer and no message left.									U	12/26/2001	12/27/2001	1	NONE	PUB	PUB	NONE	NONE	NONE		MI2002007	1						1	Erythema; Pruritus; Rash	FLU3~PFIZER\WYETH~401853~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181249	02/12/2002	AZ	48.0	48		F	12/03/2001	Flu vaccine given in left arm was moderately sore. Pneumonia vaccine given in right arm was extremely sore and could not raise arm for 3 days. On 11/14/01 evening, had a high fever, fatigue and sore muscles. Had the same reaction last year.									Y	11/14/2001	11/14/2001	0		PUB	OTH		NONE	Allergy to tetracycline	Pain at injection site, fever, reduced movement, fatigue and myalgia~Influenza (Seasonal) (no brand name)~~47.00~In Patient		1						1	Fatigue; Hypokinesia; Injection site pain; Myalgia; Pyrexia; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U0594AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0461L~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0181250	02/12/2002	AZ	31.0	31		M	12/13/2001	Left arm was sore for about 4-6 days. Rash with small bumps by the injection area, headache and stuffiness.									Y	11/14/2001	11/14/2001	0		PUB	OTH	NONE	NONE	NONE			1						1	Headache; Injection site pain; Nasal congestion; Rash erythematous	FLU3~SANOFI PASTEUR~U0594AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0181251	02/12/2002	AZ	55.0	55		F	12/18/2001	Temperature approx. 101F, headache, total body ache and especially joints, fatigue, sore throat, chest congestion and coughing up blood. Sought medical treatment from family MD on or about 11/20/01. Dx'd with bronchitis and put on Z-pack antibiotics. Asthma was triggered and is continuing.									Y	11/14/2001	11/14/2001	0		PUB	OTH		NONE	Asthma			1						1	Arthralgia; Condition aggravated; Haemoptysis; Headache; Pain; Pharyngolaryngeal pain; Pulmonary congestion; Pyrexia	FLU3~SANOFI PASTEUR~U0594AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0181292	02/12/2002	MA	50.0	50		M	12/20/2001	A 50 year old male nurse reported that he received an injection of Flu Shield (2001-2002 Formula) on 9 Nov 2001. On 16 Nov 2001, the patient developed optic neuritis of the left eye with symptoms of central vision loss. He was seen by several eye physicians who diagnosed an inflamed optic nerve. The patient stated that he is unable to see out of his left eye. An MRI was normal. Analysis of CSF revealed minimally elevated protein and no neoplastic cells. Unspecified blood work was negative. Testing for Lyme's Disease, HIV, syphilis, and multiple sclerosis were negative. He was treated for Lyme Disease with Ceftriaxone despite negative test result. The reported stated he is seeing several speciality physicians but none are able to pinpoint what is going on. He also developed fatigue which the physician feels may be related to the antibiotic therapy. Optic neuritis is considered medically important. FOLLOW-UP information received from the physician on 01/11/2002 indicated that the pt also developed weakness, myalgias, and other viral symptoms. Subsequently, the weakness, fatigue, viral symptoms and myalgias resolved.				Y					U	11/09/2001	11/16/2001	7	Nuclear magnetic resonance imaging (normal), Lumbar puncture (minimally elevated protein, no neoplastic cells seen.	OTH	OTH	vitamins NOS	UNK	Lyme Disease		HQ9594119DEC2001	1						1	Asthenia; Fatigue; Myalgia; Optic neuritis; Visual acuity reduced	FLU3~PFIZER\WYETH~4018033~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0181293	02/12/2002					U	11/08/2001	A physician reported that a patient received an injection of Flu Shield (2001-2002 Formula). Approximately 6 to 9 days later, the patient had an INR of approximately 4.2 to 5.6. The reporter noted that the patients INR had been stable at approximately 2.5 to 3 before immunization. No further information was available at the date of this report. Manufacturer's Comment: The reporter indicated that 8 patients experienced this event; however they are not presently identifiable. Additional reports will be generated when identifying information is provided.									U				UNK	PVT	OTH	UNK	UNK	UNK		HQ7682126OCT2001	1						1	Coagulation time prolonged	DT~SANOFI PASTEUR~~UNK~~~DT ADSORBED (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181294	02/12/2002	WA	3.0	3		M	01/03/2002	A nurse reported that a 3 year old male received FLUSHIEL. The child has a past history of asthma. Concomitant therapy included montelukast sodium, loratadine, and fluticasone propionate. The vaccine was inadvertently given under the deltoid. On 6 NOV 2001, the child developed an injection site reaction characterized by redness, heat and a large induration. As of the date of this report, the symptoms have improved. No additional information was available as of the date of this report. Follow up information received 28 DEC 2001. On 9 NOV 2001, the symptoms resolved and the patient recovered.									Y	11/05/2001	11/06/2001	1	No tests performed	OTH	OTH	Claritin, Flonase	NONE	Asthma		HQ8196808NOV20011328710	1						1	Injection site erythema; Injection site induration; Injection site reaction; Injection site warmth	FLU3~PFIZER\WYETH~4018028~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181295	02/12/2002	KS				U	12/17/2001	A physician reported that an unidentified patient received Flu Shield (2001-2002 Formula) (influenza virus vaccine, trivalent, types a & b/2001-2002 formula) on 6 Nov 2001. One hour post immunization, the patient experienced itching around the mouth and feeling funny. The patient was treated with fexofenadine hydrochloride (Allegra) and the symptoms resolved. No additional information was available as of the date of this report.									Y	11/06/2001	11/06/2001	0	UNK	PUB	PUB	UNK	UNK	UNK		HQ8216708NOV2001	1						1	Feeling abnormal; Pruritus	FLU3~PFIZER\WYETH~4018033~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181296	02/12/2002	PA				U	11/16/2001	A physician reported that a patient received a dose of Flu Shield (2001-2002 Formula) on 7 Nov 2001. The next day, the patient experienced feeling achy. No further information was available at the date of the report.									U	11/07/2001	11/08/2001	1	UNK	OTH	OTH	UNK	UNK	UNK		HQ8330512NOV2001	1						1	Pain	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181297	02/12/2002	KS	17.0	17		F	11/16/2001	A nurse reported that a 17 year old female may have inadvertently received a subcutaneous injection of Flu Shield (2001-2002 Formula) on 13 Nov 2001. The injection was administered approximately 3 inches above her right elbow and that same day, the patient developed an injection site reaction characterized by redness and swelling. As of the date of this report, no further information was available.				Y					U	11/13/2001	11/13/2001	0	UNK	PVT	PVT	UNK	UNK	UNK		HQ8484415NOV2001	1						1	Injection site erythema; Injection site reaction; Injection site swelling	FLU3~PFIZER\WYETH~4018030~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0181298	02/12/2002	TX				U	01/10/2002	A pharmacist reported via a nurse that a patient received an injection of Flu Shield (2001-2002 Formula). Subsequently, the patient experienced throat constriction, flushing, and sweating. The patient also developed an injection site reaction characterized by extreme pain and bruising. No further information was available at the date of this report. Manufacturer's Comment: The reporter indicated that several patients experienced these events; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ8612920NOV2001	1						1	Contusion; Flushing; Hyperhidrosis; Pain; Throat tightness	FLU3~PFIZER\WYETH~4018024~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181299	02/12/2002	SC				U	12/13/2001	A pharmacist reported that a patient received an injection of Flu Shield (2001-2002 Formula). Subsequently, the patient developed an injection site reaction characterized by redness and nodules. No further information was available at the date of the report. Manufacturer's Comment: The reporter indicated that 5 patients experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ8630420NOV2001	1						1	Erythema; Injection site nodule; Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181300	02/12/2002					F	01/03/2002	Info has been received from a healthcare professional concerning his wife who developed an injection site reaction characterized by redness, tenderness, and bruising, following administration of flu shield vaccine. No further info was available at the date of this report.									U				UNK	OTH	OTH	UNK	UNK	NKA		HQ8674121NOV2001	1						1	Contusion; Injection site erythema; Injection site reaction; Tenderness	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181301	02/12/2002	AR	67.0	67		F	11/29/2001	A pharmacist reported that his 67 year old wife received an injection of flu shield on 11/14/2001. That same day, she developed an injection site reaction characterized by tenderness, bruising, and redness.									U	11/14/2001	11/14/2001	0	UNK	PVT	PVT	NONE	UNK	UNK		HQ8679721NOV2001	1						1	Contusion; Injection site erythema; Injection site reaction; Tenderness	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181302	02/12/2002	PA	84.0	84		M	01/02/2002	Information has been received from an 84 year old consumer who received an injection of flu shield on 11/12/2001. Four days following vaccination, on 11/16/2001, the pt experienced diarrhea, a low grade fever, and a runny nose.									U	11/12/2001	11/16/2001	4	UNK	OTH	PVT	UNK	UNK	UNK		HQ8704321NOV2001	1						1	Diarrhoea; Pyrexia; Rhinorrhoea	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181303	02/12/2002	NH				F	01/03/2002	A nurse reported that a female pt received an injection of flu shield on 11/13/2001. Immediately post vaccination, the pt developed tingling at the injection site with extended to her fingertips. She also developed aching and was treated with Tylenol. She recovered the next day. This is 1 of 4 pts from this facility who has an adverse experience following receipt of flu shield.									Y	11/13/2001	11/13/2001	0	UNK	OTH	OTH	UNK	UNK	UNK		HQ8728426NOV2001	1						1	Pain; Paraesthesia	FLU3~PFIZER\WYETH~4018032~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181304	02/12/2002	NC	37.0	37		F	12/14/2001	A nurse reported that a 37-year old female received an injection of flu shield (2001-2002 Formula) on 19-Nov-2001. Approximately 7 hours post-vaccination, the patient developed swelling and a rash at the injection site. She was treated with Benadryl (diphenhydramine) and prednisone.									U	11/19/2001	11/19/2001	0	UNK	PVT	PVT	NONE	UNK	UNK		HQ8743426NOV2001	1						1	Injection site oedema; Rash	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181305	02/12/2002	NC	86.0	86		M	01/02/2002	A nurse reported that an 86 year old male received an injection of Flu Shield (2001-2002 formula) on 18-Nov-2001. Approximately 12 hours post-vaccination, the patient developed a rash on his chest, back and arms. He also developed a reddened face. The patient was treated with Benadryl (diphenhyramine)									U	11/18/2001	11/18/2001	0	UNK	OTH	OTH	UNK	UNK	concurrent Conditions: Hypertension		HQ8743626NOV2001	1						1	Erythema; Rash	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181306	02/12/2002	PA				U	12/21/2001	A physician reported that an elderly patient received a dose of Flu Shield (2001-2002 formula ) vaccine and subsequently developed shingles. The reporter declined to provide further information and declined to grant permission for follow-up investigation.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ8811027NOV2001	1						1	Skin ulcer	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181307	02/12/2002					F	12/28/2001	A nurse reported that a female patient received an injection of Flu Shield (2001-2002 formula) from a syringe that had been stored at a temperature higher than recommended. Subsequently, the patient developed a large amount of bleeding at the injection site.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ8913828NOV2001	1						1	Injection site reaction	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181308	02/12/2002	IL	48.0	48		F	01/07/2002	A nurse reported that a 48-year old female received an injection of Flu Shield (2001-2002 formula) on 08-Nov-2001 and the next day, experienced tenderness at her left neck base, left chest wall and laterally into her left breast. The patient was diagnosed with myositis and prescibed propoxyphene napsylate. She felt better the next day. The reporter spoke with the patient on 13-NOV-2001 and she was much better. This is 1 of 2 patients from this facility who experienced an adverse event following receipt of flu shield (2001-2002 Formula). See MSN HQ895892NOV2001. Additional information received 20-Dec-2001 indicated that the patient recovered.				Y					Y	11/08/2001	11/09/2001	1	UNK	OTH	OTH	UNK	UNK	UNK		HQ8957829NOV2001	1						1	Breast tenderness; Myalgia; Myositis	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0181309	02/12/2002	TX	43.0	43		F	01/21/2002	A pharmacist reported that a 43-year-old female received an injection of Flu Shield (2001-2002 Formula) on 26-Nov-2001 and the next day, developed redness, heat, pain,swelling and itching at the injection site. The patient was seen in the emergency room and a diagnosis of cellulitis was made. The patient was prescribed unspecified antibiotics. The reporter indicated that the administrator of the vaccine did not swab the injection site with alcohol prior to vaccine administration. This is 1 of 3 patients from this facility who experienced an adverse event following receipt of Flu shield (2001-2002 Formula) lot 4018040. Additional information received 28-Dec-2001 indicated that the condition on arm cleared, however, the patient developed infectious blisters on her face. The unspecified antibiotic that had been initially prescribed was changed. The blisters and arm swelling abated in less than a week following administration of a different (unspecified) antibiotic. See MCNs: HQ9047703DEC2001 and HQ9984821JAN2002.				Y					Y	11/26/2001	11/27/2001	1	UNK	OTH	OTH	UNK	UNK	concurrent conditions: Hypertension NOS		901603	1						1	Blister; Injection site erythema; Injection site hypersensitivity; Injection site oedema; Injection site pain; Injection site warmth; Pruritus	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0181310	02/12/2002	IN				F	01/07/2002	A nurse reported that a female inadvertently received a subcutaneous injection of flu Shield on 11/27/2001 and two days later, developed a red mar, the size of a coffee cup at the injection site. As of the date of this report, no further info was available.									U	11/27/2001	11/29/2001	2		OTH	OTH	UNK	UNK	UNK		HQ9047503DEC2001	1						1	Injection site erythema; Injection site oedema	FLU3~PFIZER\WYETH~4018028~UNK~SC~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181311	02/12/2002	AZ	45.0	45		F	01/03/2002	A 45 year old female reported that she received an injection of the flu virus vaccine on 11/30/2001. At that time, she developed injection site pain, experienced agitation, and felt hot. The following day, she experienced chest pain and pressure. The symptoms have since resolved. NO further info was available at the date of this report. FOLLOW-UP information received on 02/06/2002 revealed the patient received flu vaccine. this case has since been canceled.									Y	11/30/2001	12/01/2001	1	UNK	OTH	PUB	UNK	UNK	UNK		HQ9080104DEC2001	1						1	Agitation; Chest discomfort; Chest pain; Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0181312	02/12/2002	NY	45.0	46		F	01/02/2002	The pt developed an allergic reaction described as injection site redness and swelling, with fever. A diagnosis of cellulitis was made and the pt was treated with a 17 day course of an unspecified antibiotic. No further infomation was available at the date of this report.									U	10/01/2001			UNK	PVT	OTH	UNK	UNK	Crohn's disease; hep C		HQ9087604DEC2001	1						1	Cellulitis; Hypersensitivity; Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0181313	02/12/2002	AZ	69.0	69		F	01/02/2002	A consumer reported that her 69 year old mother received an injection of the 2001-2002 formula of an influenza virus vaccine on 11/30/2001. Later that day, she was taken to a local ER for shortness of breath. She was treated with an unspecified breathing treatment and was released. The pt has since recovered. No further info was available at the date of this report.				Y					Y	11/30/2001	11/30/2001	0	UNK	OTH	PUB	UNK	UNK	UNK		HQ9153805DEC2001	1						1	Dyspnoea	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0181314	02/12/2002	NY	38.0	39		F	01/02/2002	A nurse practitioner reported that a 38 year old female received a dose of Flu Shield on 12/06/2001 and immediately experienced neck discomfort and stiffness. The symptoms improved within approx 15 mins. At the date of the report, no further info was available. This is 1 of 2 patients from this facility who experienced an adverse reaction following receipt of flu shield. (2001-2002 formula) lot 4018041. FOLLOW-UP information received from the reporter on 02/05/2002, provided physician information, time of vaccination and stated that, within 24 hours post-immunization, there was no residual effect. (See related HQ9313710DEC2001)									Y	12/06/2001	12/06/2001	0	UNK	OTH	OTH	UNK	UNK	UNK		HQ9313510DEC2001	1						1	Musculoskeletal stiffness	FLU3~PFIZER\WYETH~4018041~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181315	02/12/2002	NY	57.0	57		F	01/02/2002	A nurse practitioner reported that a 57 year old female received an injection of flu shield on 12/06/2001 and immediately experienced a feeling of heaviness in her arm and shoulder. Later that day, her symptoms resolved. At the date of the report no further info was available. This is 1 of 2 pts from this facility who experienced an adverse event following receipt of flu shield vaccine.(2001-2002 formula)lot 4018041 FOLLOW-UP information received from the reporter on 02/02/2002, provided physician information and stated that the patient had no residual effect. (See HQ9313510DEC2001)									Y	12/06/2001	12/06/2001	0	UNK	OTH	OTH	UNK	UNK	UNK		HQ9313710DEC2001	1						1	Sensation of heaviness	FLU3~PFIZER\WYETH~4018041~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181316	02/12/2002	IN	48.0	48		F	01/03/2002	A 48 year old female reported that she received injections of Flu Shield and Pnu-Imune-23 on 12/06/2001. Medical history included multiple sclerosis and recent urinary tract infection for which she received 10 days of ciprofloxacin therapy (ending on 12/03/2001). Concomitant therapy included Avonex, (interferon beta), Celexa, baclofen, Provigil, and Uromax. On the evening of vaccination, the pt experienced flu-like symptoms of vomiting, diarrhea, and low-grade fever of 99 deg. F. She visited the physician on 12/10/2001 and was prescribed Compazine for vomiting. She was also diagnosed with another urinary tract infection for which she was prescribed Bactrim. FOLLOW-UP information was received on 01/15/2002 from the pt's physician. the pt's medical history included multiple sclerosisis, depression, andasthma. Other concomitant therapies included Topamax, Ditropan, Cylert and Advair. A complete blood countperformed on 12/06/2001 was within normal limits. The reporting physician felt that the symptoms were due to the urinary tract infection rather than an immunization reaction.				Y					U	12/06/2001	12/10/2001	4		OTH	OTH	Avonex, Baclofen, Celexa	UNK	multiple sclerosis, urinary tract infection NOS		HQ9596419DEC2001	1						1	Diarrhoea; Influenza like illness; Pyrexia; Urinary tract infection; Vomiting	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0181317	02/12/2002	MO				U	01/02/2002	A pharmacist reported that 10 to 14 nursing home pts received an injection of flu shield and subsequently, developed a rash with small blood blister appearance on the trunk and some pts developed this rash on their scalps. As of the date of this report, no further info was available. The reporter indicated that 10-14 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying info is provided.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ9612721DEC2001	1						1	Rash vesicular	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181318	02/12/2002	MD				F	01/02/2002	A pharmacist reported that a physician's wife inadvertently received two doses  of flu shield and subsequently developed an injection site reaction characterized by erythema and pain. No further information was available at the date of this report.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ9622421DEC2001	1						1	Injection site erythema; Injection site pain; Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181319	02/12/2002					F		Report from a consumer who experienced swelling and bleeding at an influenza injection site eight months after starting Enbrel.									U				UNK	OTH	OTH	Enbrel	UNK	UNK		HQ9713102JAN2002	1						1	Injection site inflammation; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181320	02/12/2002	MO				U	01/02/2002	A pharmacist reported that an unidentified pt of a nursing home received flu shield vaccine. The pt developed tingling and a sensation which felt like a vaccine was running down their arms, for a period of 20 seconds. No additional info was available as of the date of this report. The reporter indicated that 6 pts from this facility experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying info is provided.									Y				UNK	OTH	OTH	UNK		UNK		HQ8318912NOV2001	1						1	Paraesthesia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181321	02/12/2002	IA				F	11/20/2001	A nurse reported that a female pt received a dose of flu shield vaccine on 11/05/2001 and developed an injection site reaction characterized by redness, warmth, and pain. The pt recovered. The reporter indicated that 2 pts experienced this event following receipt of the vaccine; however, the second pt is not presently identifiable. An additional report will be generated when identifying info is provided.									Y	11/05/2001	11/05/2001	0	UNK	OTH	OTH	UNK	UNK	UNK		HQ8366713NOV2001	1						1	Feeling hot; Injection site erythema; Injection site reaction; Pain	FLU3~PFIZER\WYETH~4018027~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181322	02/12/2002	CO				U	11/20/2001	A pharmacist reported that a pt received a dose of flu shield on 11/06/2001 and within 6-8 hours, developed an injection site reaction measuring 6cm to 8cm in diameter characterized by redness, swelling, heat and pain. The reporter indicated that 9 pts experienced this reaction; however, they are not presently identifiable. Additional reports will be generated when identifying info is provided.									U	11/06/2001			UNK	OTH	OTH	UNK	UNK	UNK		HQ8428114NOV2001	1						1	Feeling hot; Injection site erythema; Injection site pain; Injection site reaction; Injection site swelling	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181323	02/12/2002	KY				U	12/26/2001	A pharmacy student reported that an unspecified number of pts received an injection of flu shield. subsequently, the pt developed an injection site reaction characterized by a quarter-sixed area of hot, red-wheeled indurations. No further info was available at the time of this report. The reporter was unable to specify the number of pts who experienced this event. Additional reports will be generated when identifying info is provided.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ8617020NOV2001	1						1	Injection site reaction	FLU3~PFIZER\WYETH~4018040~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181324	02/12/2002	TN				U	11/27/2001	A company representative reported that a pt received an injection of flu shield. Subsequently, the pt developed an injection site reaction characterized by redness and swelling. No further info was available at the date of this report. The reporter was unable to specify the number of patients who experienced this event. Additional reports will be generated when identifying info is provided.									U				UNK	OTH	OTH	UNK		UNK		HQ8708521NOV2001	1						1	Injection site erythema; Injection site reaction; Injection site swelling	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181325	02/12/2002	NH				F	01/07/2002	A nurse reported that a female pt received an injection of flu shield on 11/15/2001. At the time of immunization, the pt developed pain at the injection site which radiated to her fingertips. Later that same day, the pt developed nausea, vomiting, and her arm ached. On 11/016/2001, she developed a rash on her back. Her symptoms resolved in 48 hours. This is 1 of 4 pts who had an adverse experience following receipt of flu shield.									Y	11/15/2001	11/15/2001	0	UNK	OTH	OTH	UNK	UNK	respiratory disorder NOS		728126	1						1	Injection site pain; Nausea; Rash; Vomiting	FLU3~PFIZER\WYETH~4018032~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181326	02/12/2002	NH				U	01/03/2002	A nurse reported that a pt received an injection of flu shield and subsequently developed induration at the injection site. The pt recovered. This is 1 of 4 pts from this facility who had an adverse experience following receipt of flu shield. The reporter indicated that lot 4018032 had expired June, 2001; however, Product Quality has indicated that this is a valid flu shield lot number.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ8728326NOV2001	1						1	Injection site induration; Injection site reaction	FLU3~PFIZER\WYETH~4018032~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181327	02/12/2002	NH				F	01/03/2002	A nurse reported that a female pt received an injection of flu shield on 11/13/2001. That same day, the pt developed a grapefruit-sized welt at the injection site. This is 1 of 4 pts from this facility who had an adverse experience following receipt of flu shield.									U	11/13/2001	11/13/2001	0	UNK	OTH	OTH	UNK	UNK	UNK		HQ8729426NOV2001	1						1	Injection site reaction; Urticaria	FLU3~PFIZER\WYETH~4018032~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181328	02/12/2002	TX				F	12/10/2001	A nurse reported that a female pt in her fifties received an injection of flu shield on 11/15/2001 and an injection of pnuimune23 on 11/16/2001. Approx. 10 hours following pnuimune23 administration, the pt went to a local emergency with a fever of 106 deg F.; however, the pt was not hospitalized. No further info was available at the date of this report.				Y					U	11/15/2001	11/16/2001	1		OTH	OTH	UNK	UNK	UNK		HQ8752626NOV2001	1						1	Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0181329	02/12/2002	MI				F	12/17/2001	A healthcare professional reported that a female pt received an injection of flu shield on 11/27/2001. Immediately following immunization, the pt developed pain at the injection site. She was seen by a physician and treated with applications of ice to the affected area. No further info was available at the date of this report.				Y					U	11/27/2001	11/27/2001	0	UNK	OTH	PVT	UNK	UNK	UNK		HQ8956228NOV2001	1						1	Injection site pain	FLU3~PFIZER\WYETH~4018040~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0181330	02/12/2002	CT				U	01/02/2002	A physician reported that a pt received an injection of flu shield on 11/26/2001. Subsequently, the pt developed swelling at the injection site. No further info was available at the date of this report. the reporter indicated that 2 patients experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying info is provided.									U	11/26/2001			UNK	OTH	OTH	UNK	UNK	UNK		HQ8992029NOV2001	1						1	Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181331	02/12/2002	FL	71.0			F	12/10/2001	A physician reported that his 71 year old wife received an injection of flu shield on an unspecified date. On 11/24/2001, approx 2 weeks following vaccination, the pt experienced nausea, vomiting, and diarrhea. No further info was available at the date of this report.									U		11/24/2001		UNK	PVT	PVT	Lipitor	UNK	UNK		HQ8998029NOV2001	1						1	Diarrhoea; Nausea; Vomiting	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181332	02/12/2002	TX	26.0	26		F	01/21/2002	A pharmacist reported that a 26-year-old female received an injection of Flu Shield (2001-2002 Formula) on 26-Nov-2001 and the next day, developed an injection site reaction characterized by redness and minor swelling. The patient recovered within 48 hours. The reporter indicated that this event was possibly due to the reported absence of swabbing injection site prior to vaccine administration. As of the date of this report, no further information was available. This is 1 of 3 patients for this facility to experience an adverse event following receipt of flu shield (2001-2002 formula lot 4018040. See MSNs: HQ9041603DEC2001 and HQ9984821JAN2002									Y	11/26/2001	11/27/2001	1	UNK	OTH	OTH	UNK	UNK	UNK		HQ9047703DEc2001	1						1	Injection site erythema; Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181333	02/12/2002					U	01/07/2002	A pharmacist reported that 8 out of 10 patients developed injection site reactions following receipt of Flu Shield from two specific lots. The reactions following receipt of Flu Shield from two specific lots. The reactions were characterized by stinging and redness. MANFACTURER'S Comment: The reporter indicated that 8 patients experienced these events; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ9120405DEC2001	1						1	Erythema; Pain	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181334	02/12/2002					U	12/10/2001	A pharmacist reported that a child (age and gender unspecified) received an injection of Flu Shield (2001-2002 formula) on 29-Nov-2001. The following day, the child developed a lacey rash over the trunk and extremities. By 3-Dec-2001, the rash had spread to legs and became red, hot, and itchy. The child was being treated with Zyrtec  (cetirizine). No further information was available at the date of this report.									U	11/29/2001	11/30/2001	1	UNK	UNK	OTH	UNK	UNK	UNK		HQ9201706DEC2001	1						1	Erythema; Feeling hot; Pruritus; Rash	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181335	02/12/2002	MD				U	12/13/2001	A nurse reported that an employee received a dose of Flu Shield (2001-2002 formula) on 04-Dec-2001. Two days later, the patient developed an injection site reaction characterized as silver dollar size, dark, red and warm. Manufacturer's comment The reporter indicated that 15 out of 16 employees experienced this reaction following receipt of Flu shield (2001-2002 Formula) lot 4018032; however, the other employees are not presently identifiable. Additional  reports will be generated when identifying information is received.									U	12/04/2001			UNK	OTH	OTH	UNK	UNK	UNK		HQ9263607DEC2001	1						1	Injection site erythema; Injection site reaction; Injection site warmth; Skin discolouration	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181336	02/12/2002	MN				F	01/03/2002	A nurse reported that a female employee of a clinic received flu shield vaccine on 11/16/2001. On 11/16/2001, she developed an injection site reaction characterized by pain. The reporter noted that the employee may be allergic to thimerosal. No additional info was available as of the date of this report.									U	11/16/2001	11/16/2001	0	UNK	OTH	OTH	NONE	UNK	Psoriasis		HQ9354111DEC2001	1						1	Injection site pain; Injection site reaction	FLU3~PFIZER\WYETH~4018028~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181337	02/12/2002	WI	36.0			F	01/03/2002	A nurse reported that a patient received an injection of Flu Shield (2001-2002 Formula) and subsequently developed an injection site reaction characterized by a quarter to half dollar-sized area of redness and heat. The patient was treated with Tylenol (acetaminophen) and applications of ice to the affected area. NO further information was available at the date of this report. Manufacturer's Comment: The reporter indicated that 24 patients experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ9387712DEC2001	1						1	Injection site erythema; Injection site reaction; Injection site warmth	FLU3~PFIZER\WYETH~4018046~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181338	02/12/2002	PA	50.0	50		F	01/02/2002	A nurse reported that a 50 year old female received an injection of Flu shield on 12/10/2001. The next day, she developed fever, chills and generalized body aches which persisted for 3 days.									U	12/10/2001	12/11/2001	1		OTH	OTH	UNK	UNK	UNK		HQ9622821DEC2001	1						1	Pain; Pyrexia	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181339	02/12/2002					M	01/02/2002	A nurse reported that a male received an injection of Flu Shield (2001-2002 Formula) on 30 NOV 2001. That day, he developed pain at the injection site which was still present after two weeks. No further information was available at the date of this report.									U	11/30/2001	11/30/2001	0	UNK	OTH	OTH	UNK	UNK	UNK		HQ9683028DEC2001	1						1	Injection site pain	FLU3~PFIZER\WYETH~4018038~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181340	02/12/2002	DC	1.5	1	.6	M	01/07/2002	A nurse reported that an 18 month old male received an injection of Flu Shield (2001-2002 Formula) on 28 DEC 2001. Immediately following immunization, the child developed an injection site reaction characterized by a 12 mm by 13 mm reddened, raised, hive.									U	12/28/2001	12/28/2001	0	UNK	PVT	PVT	NONE	UNK	UNK		HQ9710302JAN2002	1						1	Injection site reaction; Urticaria	FLU3~PFIZER\WYETH~4018030~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181341	02/12/2002	TX	25.0	25		F	01/21/2002	A pharmacist reported that a 25 year old female received an injection of Flu Shield (2001-2002 Formula) on 26 NOV 2001 and the next day, developed an injection site reaction characterized by redness, pain, and slight swelling. The patient recovered without treatment within 48 hours. The reporter indicated that this event was possibly due to the reported absence of swabbing injection site prior to vaccine administration. As of the date of this report, no further information was available. This is 1 of 3 patients from this facility to experience an adverse event following receipt of Flu Shield (2001-2002 Formula) lot 4018040. See MCNs: HQ9047003DEC2001 and HQ9041603DEC2001.									Y	11/26/2001	11/27/2001	1	UNK	OTH	OTH	UNK	UNK	UNK		HQ9984821JAN2002	1						1	Injection site erythema; Injection site pain; Injection site reaction; Injection site swelling	FLU3~PFIZER\WYETH~4018040~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181342	02/12/2002	NY				F	03/11/2002	The patient developed a worse than normal skin reaction all over her body. The reporter noted that at the time of the vent, she attributed these symptoms to the winter weather and dry skin. The consumer reported two similar occurrences following immunizations with a flu vaccine. See Case ID HQ9120305DEC2001 and HQ8356213NOV2001. No additional information was available as of the date of this report. Follow-up info received on 02/19/2002 from consumer contained name and address of treating physician. The reporter states she has received the flu shot for over 8 years. Over the last 8 years, she has developed increasingly worsened rashes, each winter, spreading to more areas of her body, mostly her hands, arms and legs. She has also developed uncontrollable itching on the back, face and gums. The consumer stated that her legs and arms would bleed from the itching rashes. In the last few years she has developed borderline asthma. The consumer also noted htat she chose not to receive the flu shot this year and so far has not experienced any of these symptoms. Her dermatologist, determined a positive skin test to thimerosol. FOLLOW-UP information received 04/02/02. The skin test  was noted to be patch test and was performed  12/18/98.				Y					Y				Skin test-positive (thimerosol)	OTH	OTH	UNK	UNK	Eczema, Hypersensitivity, asthma NOS, bronchitis NOS		HQ9120205DEC2001	1						1	Dermatitis	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0181343	02/12/2002	MT	56.0			F	12/13/2001	A nurse reported that a 56 year old female received an injection of Flu Shield (1999-2000 Formula). Subsequently, she developed an injection site reaction characterized by redness, soreness, and warmth which extended to her elbow. The symptoms resolved in 5 days.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ9179606DEC2001	1						1	Feeling hot; Injection site erythema; Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181344	02/12/2002		31.0			M	10/17/2001	A physician reported that a 31 year old male received Flu Shield (2000-2001 formula) in November 2000. The patient subsequently developed hives and numbness in his right foot, right leg, right side of face and right arm. As of the date of this report these symptoms are continuing. He was seen by his primary HCP. A neurological exam was negative, with normal MRI and normal nerve conduction studies. The patient was referred to an allergist. No additional information was available as of the date of this report.				Y					U				Nuclear magnetic resonance imaging (normal), Nerve conduction studies (normal)	PVT	OTH	UNK	UNK	UNK		HQ6969110OCT2001	1						1	Hypoaesthesia; Urticaria	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0181345	02/12/2002	NY				F	12/10/2001	A female consumer reported that she received influenza virus vaccine, trivalent, types a&b (2000-2001 formula)(manufacturer unknown) vaccine. The patients concurrent illnesses include hypersensitivity and eczema with past history of bronchitis and asthma. Following the immunization she developed a worse than normal skin reaction all over her body. The reporter noted that at the time of the event, she attributed these symptoms to the winter weather and dry skin. The consumer reported to similar occurrences following previous immunizations with a flu vaccine. See Case ID HQ9120205DEC2001 and HQ9120305DEC2001. No additional information is available as of the date of this report. A 15-day follow up report received 5/15/2002 adds: Follow up info received 02/19/2002 from pt, contained name and address of treating physicians. The reporter states she has received the flu shot for over 8 years. Over the last 8 years, she has developed increasingly worsened rashes, each winter, spreading to more areas of her body, mostly her hands, arms and legs. She has also developed uncontrollable itching on the back, face and gums. The pt stated that her legs and arms would bleed from the itching rashes. In the last few years she has developed borderline asthma. The pt also noted that she chose not to receive the flu shot this year and so far has not experienced any of these symptoms. Her dermatologist determined a positive skin test to thimerosol.									U				UNK	OTH	OTH	UNK	UNK	Eczema, Hypersensitivity		HQ8356213NOV2001	1						1	Skin reaction	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181346	02/12/2002					U	01/02/2002	A pharmacist reported that an unidentified patient received Flu Shield (influenza virus vaccine, trivalent, types A&B)(formula year not identified). Eight weeks post immunization, the patient developed brachial neuritis and subsequently recovered. No additional information was available as of the date of this report.									Y					OTH	OTH	UNK	UNK	UNK		HQ8380313NOV2001	1						1	Neuritis	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181347	02/12/2002	MT	56.0			F	12/10/2001	A nurse reported that a 56 year old female received an injection of Flu Shield (2000-2001 Formula). Subsequently, she developed an injection site reaction characterized by redness, soreness and warmth which extended to her elbow. The symptoms resolved in 5 days. A 15-day follow up report received 5/15/2002 adds: Follow-up info received on 02/05/2002 indicated that the pt received an injection of Flu Shield (2000-2001 Formula) on 12/04/2001. That same day, the pt developed the injection site reaction.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQ8940328NOV2001	1						1	Feeling hot; Injection site erythema; Injection site reaction	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181129	02/13/2002	MI	65.0	65		F	02/05/2002	Pt broke out in hives, swelling around eyes drainage from her ears. Was put on Prednisone 4 different times and anti histamine 5 days later skin peeled. One week later antibiotics for ear infection. On Prednisone again.				Y					N	11/07/2001	11/14/2001	7	2/28/02 CBC & Sed rate-WNL. Tissue biopsy - results subq dermatitis	PVT	PVT	Premarin, multiple vitamin, calcium supplement	NONE	NONE			1						2	Ear disorder; Eye oedema; Infection; Pruritus; Skin exfoliation; Urticaria; Dermatitis; Eye discharge; Face oedema; Urticaria; Chills; Fatigue; Headache; Otitis media; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0575AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0575AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~474938~1~IM~RA~PNEUMO (PNEUMOVAX)~2|IPV~SANOFI PASTEUR~U0575AA~UNK~SC~LA~POLIO VIRUS, INACT. (POLIOVAX)~3|PPV~UNKNOWN MANUFACTURER~~1~IM~~PNEUMO (NO BRAND NAME)~3	USA	Emergency room visit	Influenza
0181358	02/13/2002	SC	63.0	63		M	01/23/2002	Pt complained  of L arm numbness from injection site down to L pinkie. Saw FMD and was given anti-inflammatory meds after better, next day, numbness sore. No office notes attached.				Y					Y	01/23/2002	01/23/2002	0		PUB	PUB	Provachol, ASA	NONE	hyperlipidemia		SC0203	1						1	Hypoaesthesia	FLU3~SANOFI PASTEUR~U0699AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~SMITHKLINE BEECHAM~705B6~1~IM~LA~HEP A (HAVRIX)~1|TD~SANOFI PASTEUR~U0268AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1|TYP~SANOFI PASTEUR~T1052~1~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0181373	02/13/2002	MI	41.0	41		F	02/08/2002	Complained of redness, 3x3 raised area around injection site. Swelling into axilla and tenderness. Temperature of 100.6.									Y	10/29/2001			NONE	PVT	PVT	MVI	Viral Upper Respiratory Infection	NONE			1						1	Injection site erythema; Injection site swelling; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~U0574AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0995L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0181404	02/14/2002		51.0	50		F	10/10/2002	A report was rec'd from a hlth professional on 1/30/02 regarding a female pt who experienced injection site reaction, acute viral illness and arm weakness which was considered disabling after receiving a Fluvirin vaccine in 10/01. The pt has had a previous influenza vaccination (brand not specified). In 10/01 the pt rec'd a Fluvirin vaccine and was on an unknown date experienced painful arm at injection site which resolved. Two months later the pt had an acute viral illness which included swollen glands. The pt's arm also became swollen and painful, her arm still remains painful especially around the site of vaccination. The pt feels her arm is weaker and is receiving physical therapy treatment. The pt had not recovered at the time of reporting the event. the reporter did not provide a causality assessment. Follow up 01/20/05: A follow up report was received on 04/16/02 stating that the patient, a 50 year ol female who had received Fluvirin on 11/02/01, had recovered from her general lack of wellbing, but was stil experiencing should pain in the left shoulder, which the reporter felt may be possible tendonitis, arm pain-tender over deltoid and bicept tendon, and exhibited a decreased range of movement. The patient was being trated with physiotherapy and NSAIDS. The painful swollen arm from the injection site reaction was still present. The reactions were still painful, although improved, on 04/10/02. The reporter has assesd the relationship of Fluvirin to the reactions as possible.								Y	U	10/01/2001				OTH	OTH	Concomitant drugs not reported				PJP200200125	1						1	Asthenia; Injection site reaction; Lymphadenopathy; Viral infection	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0181418	02/15/2002	NE	22.0	22		F		Redness, swelling, tenderness, warmth to touch at injection site lasting several days.									Y	12/02/2001	12/28/2001	26		PVT	UNK						1						1	Feeling hot; Injection site erythema; Injection site swelling; Tenderness	FLU3~PFIZER\WYETH~401803~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181419	02/15/2002	NE	4.0	4		M	02/15/2002	Redness, swelling, tenderness, warmth to touch at site of injection lasting several days.									Y	01/07/2002	02/02/2002	26		PVT	PVT		NONE				1						1	Feeling hot; Injection site erythema; Injection site oedema; Pain	FLU3~PFIZER\WYETH~4018052~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PNC~PFIZER\WYETH~483176~UNK~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0181420	02/15/2002	NE	11.0	9		F	02/15/2002	Swelling, tenderness, redness to injection site. Area felt warm to touch for several days with these symptoms.									Y	11/20/2001	12/01/2001	11		PVT	PVT		NONE				1						1	Injection site reaction	FLU3~PFIZER\WYETH~4018052~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181421	02/15/2002	NE	9.0	9		F	02/15/2002	Swelling, redness, tenderness, warm to touch at site of injection see in ER for treatment with predison and benadryl.				Y					Y	02/02/2002	02/02/2002	0		PVT	PVT	Advair		asthma			1						1	Injection site reaction	FLU3~PFIZER\WYETH~4018052~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0181423	02/15/2002	VA	58.0	58		F	02/15/2002	Took shot on Wednesday. Started to get ill on Thursday by midnight, temp 103, vomiting, diarrhea all night, swelling in the arm to elbow and very sore. All day on Friday, some what better.									Y	01/23/2002	01/24/2002	1		PVT	PVT						1						1	Diarrhoea; Myalgia; Pyrexia; Swelling; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0181457	02/19/2002	IA	68.0	67		M	10/19/2001	We were contacted by HD who received a call from a MD stating pt received flu shot on 10/09/01 and developed rigors and a fever of 103F later that night. He was seen in ER and developed cardiogenic shock and died.	Y	10/10/2001							N	10/09/2001	10/10/2001	1	C & S X 2-reported as staph aureus	PUB	PVT		NONE	Heart valve replacement; CAD		IL01053	1						1	Bacterial infection; Cardiogenic shock; Chills; Pyrexia	FLU3~SANOFI PASTEUR~U0572EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0181487	02/20/2002	TX				M	02/14/2002	It was reported that an adult male pt received a Fluzone SV '01-'02 vaccination given at his workplace on the morning of 11/2/01. At 10:00 on 11/3/01, he began vomiting violently and lost all hearing in her right ear and was extremely dizzy. He was admitted to the hospital where they were able to control the vomiting, however the deafness in his right ear and the extreme dizziness continues to this day; over 3 months later. Two specialists were consulted as well as an ENT. CT scans have been done and have found nothing that could cause this. The pt has been given oral steroids as well as an injection of steroids directly into the middle ear without any change in his condition.					Y				U	11/02/2001	11/03/2001	1	CT Scans-neg	UNK	UNK					U200200121	1						1	Dizziness; Hypoacusis; Vomiting	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0181518	02/20/2002	GA	65.0	65		F	12/04/2001	On 12/04/2001 at about 1hr after receiving flu shot her lips began to tingle, has to clear her throat frequently and her breathing is not quiet right Was advised to to to ER if symptoms get worse.									U	12/04/2001	12/04/2001	0	NONE	PUB	PUB	flovent, beclovent, hyzaar	NONE	emphysema, high blood pressure		GA020003	1						1	Paraesthesia; Respiratory disorder; Throat tightness	FLU3~EVANS VACCINES~09881LA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0181522	02/20/2002	MO	21.0	21		M	02/04/2002	Pt developed muscle tightening and numbness in deltoid down to 4th and 5th finger with cramping within 6 hours. Resolved by next morning.									Y	01/29/2002	01/31/2002	2		OTH	PUB		NONE	Allergy to Prilosec			1						1	Hypoaesthesia; Muscle spasms; Musculoskeletal stiffness	FLU3~PFIZER\WYETH~4018042~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181525	02/20/2002	TX	76.0	76		F	02/06/2002	Client states she developed back pain several days after vaccination, then big toe became numb progressive to feet and legs up to hips. By day 10 was unable to walk. continues to need a cane for stability. regained ability to walk approximately 2 weeks ago.									N	11/06/2001	11/13/2001	7		PUB	PUB		NONE reported			TX02021	1						1	Back pain; Gait disturbance; Hypoaesthesia	FLU3~EVANS VACCINES~E06731KA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0181540	02/20/2002	GA	49.0	49		F		Soreness noted on 12/6/01 at approx. 18:00. Noted swelling and redness upon getting up this morning. On 12/7/01, warm to touch. Saw PMD this AM and was instructed to take Motrin or Tylenol and continue with ice packs.				Y					Y	12/06/2001	12/07/2001	1		PUB	PUB	UNK	NONE	NONE		GA02001	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~PFIZER\WYETH~4018038~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0181582	02/21/2002	NY	29.0			F	02/11/2002	The patient states that, I have experienced persistent bilateral foot problem of unclear etiology since Feb of 2000. I do not recall the exact date of my flu shot, but I believe that I received a flu vaccine, through my employee health office, about 1-3 weeks prior to the onset of my symptoms. I have attempted to obtain the exact date of inoculation through my employer. However, the employee health and medical records staff are unable to provide me with documentation re:date of my flu shot. I have seen many physicians/specialists and have undergone many diagnostic tests in the past 2 years. Many diseases, such as multiple sclerosis, several types of neuropathies, Lyme diseases, autoimmune diseases, etc.., have been ruled out through diagnostic tests, including foot/ankle/brain/spine MRIs, x-rays, and blood tests. I still do not have a clear diagnosis. Many physicians have suggested that my symptoms and subsequent physical limitations may be related to a virus, but it is only in the recent month that a new neurologist has recommended that I formally file a VAERS form. My symptoms are localized to the bottoms of both of my feet. Prior to pain management with medication, I experienced extremely severe hot knife-stabbing pain, which restricted my ability to tolerate standing (even for 5 mins) or walking. I also experienced paresthesias/numbness even when I was not weighbearing. I also lost motor function of 2 of my toes and developed ankle weakness. I have been severely limited in function since onset of these symptoms. I was essentially housebond the first 3 months of these symptoms. I was gradually able to tolerate more walking once I started taking neurontin and with the use of crutches (which allowed me to walk maybe 200 ft before my symptoms would increase). After about one year, I was finally able to walk very short distances (and not on a daily basis) with a cane. Presently, my walking and standing tolerance is still very limited as compared to my previously active lifestyle. Because of unclear etiology of my symptoms, I have essentially been medically managed with medication. Throughout the last 2 years, I have continued to make very slow progress in terms of increased walking/standing tolerance, and my physicians are unable to offer clear explanations for the onset of symptoms and my natural progress in the absence of a clear diagnosis and treatment plan. As mentioned above, some of these physician have suggested a viral cause. I have attempted to provide you with a brief description of my situation. per  doc #213154, 60 day follow-up, incomplete, but continuing recovery from foot pain, loss of left 4th and 5th toes, ankle weakness.				Y				Y	N		02/08/2000		MRIs, x-rays, blood tests.	PUB	OTH	Ventolin	fatigue, stuffy nose	asthma			1						1	Difficulty in walking; Hypokinesia; Muscular weakness; Pain in extremity; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0181583	02/21/2002	SC	13.0	13		F	02/04/2002	Site at left deltoid, erythema, warm to touch and edema (5cm X 5cm) area. Treated with Zyrtec 10mg and Singulair 10mg both bid X 3 days. Use ice X 1 hour X 3 days and Tylenol X 3 days.									Y	01/31/2002	02/01/2002	1		PVT	UNK	Singulair; Zyrtec; cromolyn and Xopenex on nebulizer TX	Asthma and Depression	Asthma; allergies			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U0690AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~PFIZER\WYETH~479265~2~IM~RA~HIB (HIBTITER)~1|PPV~MERCK & CO. INC.~0995L~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U0375AA~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0181584	02/21/2002	SC	37.0	37		F	01/30/2002	Client called on 1/30/02 at 14:15, to report that she had 6 red, blotchy, hive-like, raised whelps on right arm where vaccine was given. The largest is 1-2 in diameter and the other 5 were 1/2 in diameter. She states the area does not itch, nor are they sore. She first noticed areas at 19:00 on 1/30/02. She has not gone to MD and don't plan to since they're not causing trouble. Called us to let us know since she didn't see this as a reaction on the form we gave her. States she doesn't have this rash anywhere else on her body.									Y	01/29/2002	01/30/2002	1		PUB	UNK			Client stated at the time of vaccine; Asthma and the beginnings of emphysema.		SC0204	1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U0708AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1160L~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0181585	02/21/2002	TX	37.0	37		M	02/11/2002	Pt was given vaccine on 1/22/02. On 2/4/02, after vigorous exercise, he developed severe proximal arm aching with gradual onset of severe headache over a 5-7 day period. He was evaluated on 2/7/02 in the office with severe elevation of CPK to 87,000. On 2/8/02 was admitted to the hospital with rhabdomyolysis, aseptic meningitis and hepatitis. He is better but is still in ICU.				Y	Y				U	01/22/2002	02/04/2002	13	Spinal Tap; CPK-87,000 (elevated)	PVT	PVT	? Rip Fuel, weaned; Zoloft; Prevacid 15 prn	NONE	GERD; Smoker; Mild cholesterol elevation-no meds			1						1	Headache; Hepatitis; Laboratory test abnormal; Meningitis aseptic; Pain; Rhabdomyolysis	FLU3~SANOFI PASTEUR~U0701AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0181586	02/21/2002	PA	27.0	27		M	01/22/2002	Approx. 1-2 hours, post vax, the pt was reported to break out in hives with severe itching. He called his MD and was given a prescription for Benadryl.									Y	12/10/2001	12/10/2001	0	NONE	PUB	OTH	NONE	NONE	NONE			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0683AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0181588	02/21/2002	CA	61.0	60		M	02/14/2002	Six hours, post vax, I came down with a light case of flu symptoms (nasal congestion and muscle pains), which increased over several days in severity. No temperature. Muscle pain increased in severity and started first in the lower back and now has moved to the arm, legs and hip joints. It took about 1 1/2 weeks for the nasal congestion to abate. The pain severity has slightly decreased, but is still persistent after 6 weeks, making it just bearable to rise from an automobile seat. Exercise helps, but rising after sitting in one place for any length of time is painful. Ibuprofen and aspirin have little effect.									N	01/03/2002	01/03/2002	0		PVT	PVT	NONE	NONE	NONE	~Tetanus Toxoid (no brand name)~~10.00~In Sibling		1						1	Arthralgia; Back pain; Myalgia; Nasal congestion	FLU3~SANOFI PASTEUR~U0699AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0181590	02/21/2002	GA	22.0	22		F	02/12/2002	Per pt hx. small (app 10mm) area of swelling and redness @ injection site noted upon working 2/7/02. Reports gradual increase in size of local reaction and itching on2/12/02 local reaction @ injection site 2 1/2 X 2 of redness with slight amount of swelling. Tender to touch and itching. Generally feels bad, feels like she is coming down with something.				Y						02/06/2002	02/07/2002	1	N/A	MIL	MIL		NO				1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Pruritus; Tenderness	FLU3~SANOFI PASTEUR~U0704AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|YF~SANOFI PASTEUR~UB102AA~2~SC~LA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0181627	02/22/2002	TX	44.0	45		M		Mild urticaria about 20 mins after immunizations 4-5 lesions on back, left arms with some mild edema of lower lip. Before patient left the clinic lesions on back disappeared and lip swelling was reduced. Benadryl 50 mg IM right deltoid , lot #019223									Y	02/14/2002	02/14/2002	0		PUB	PVT		NONE	NONE			1						1	Face oedema; Skin ulcer; Urticaria	FLU3~SANOFI PASTEUR~U0725AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0956L~2~IM~RA~HEP B (RECOMBIVAX HB)~1|HEPA~MERCK & CO. INC.~1569L~2~IM~LA~HEP A (VAQTA)~1|TYP~CONNAUGHT LABORATORIES~T10522~2~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|YF~CONNAUGHT LABORATORIES~UB077AA~1~SC~LA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0181673	02/25/2002	TX	47.0	47		F	02/05/2002	Hives and rash									Y	01/02/2002	01/09/2002	7	NONE done	PUB	PUB		NONE	UNK		SA0202	1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~UO712AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0181674	02/25/2002	WV	63.0	63		F	02/12/2002	Severe arm pain, Extreme tenderness at injection site, Very limited mobility.				Y					N	11/29/2001	11/29/2001	0		UNK	PVT		NONE				1						1	Injection site pain; Joint range of motion decreased; Myalgia	FLU3~SANOFI PASTEUR~U0708AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1160L~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0181675	02/25/2002	WV	40.0	39		F	02/12/2002	Arm pain, limited mobility, tenderness at injection site									N	11/27/2001	11/27/2001	0		OTH	PVT		NONE	Ilosone			1						1	Injection site pain; Myalgia; Rales	FLU3~SANOFI PASTEUR~U0708AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0181676	02/25/2002	OR	55.0	54		F	02/14/2002	Got Flu shot 12/5/01, Lower left forearm. Pain 2 weeks later, Pain increased arm and decreased hand with numbness and pressure on fingers, Called MD, Advised to see doctor. On 12/21/01, went to doctor, Diagnosis-pinched nerve in neck, 12/24/01-severe neck pain, Went to hospital 1/3/02, Had MRI-saw neurologist, Diagnosis -bulging disc in neck-had fall 1 week prior to flu shot.									Y	12/05/2001	12/07/2001	2	1/3/02-MRI	PUB	PVT	Lipitor, Prempro	NONE	NONE		OR200208	1						1	Hypoaesthesia; Myalgia; Neuralgia	FLU3~PFIZER\WYETH~4018028~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181677	02/25/2002	MN	52.0	52		M		Severe shoulder pain initially felt pain at site, Later in shoulder, Cracking from site, then joint persistent pain scan at 3 weeks, Cracking subsided, 6-800 mg ibuprofen for 3 X  1 day.									N	11/07/2001	11/08/2001	1	x-ray 1 wk ago-nothing was found	PVT	PVT	NONE	NONE	NONE			1						1	Injection site pain; Pain	FLU3~SANOFI PASTEUR~U0591EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0181716	02/26/2002	WY	49.0	49		F	12/06/2001	A 49 year old caucasian female received a flu vaccine and 15 minutes, post vax, she began to feel flushed, itchy and a scratching in her throat. The RN got help from the other RN. ER was called the order was given to give pt .3cc SC and 50mg Benadryl IM. Pt waited 10 minutes after meds were given and her niece picked her up and took her to ER for monitoring. Pt was monitored in ER for 1 1/2 hours. Pt called the next AM and stated she had difficulty sleeping last night and continued to feel a bit itchy, but doesn't complain of throat itchiness. Pt was recommended to follow-up with her physician before receiving further flu vaccines.				Y					Y	12/05/2001	12/05/2001	0		PUB	PUB	Epi-Pen; Benadryl prn	NONE	History of allergy testing the previous year.		WY0201	1						1	Flushing; Insomnia; Pruritus	FLU3~PFIZER\WYETH~4018040~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0181717	02/26/2002	WY	33.0	34		F	12/19/2001	On 12/18/01 at 08:00, woke up feeling weak and body felt heavy and felt feverish. At 08:30, began having hot flashes, breathing difficulty and needing to take deep breaths. At 14:00, face and hands turned red and started itching. At 15:30, went to MD's office and was developing hives, mottling and itching over entire body. On 12/19/01, continued itching but redness resolving. Received Depo-Medrol 40mg, IM. Now am taking Zyrtec 10mg 1 Tab for allergic reaction.				Y					N	12/17/2001	12/18/2001	1	NONE	PUB	PUB	NONE	NONE	Aspenia		WY0202	1						1	Asthenia; Dyspnoea; Feeling hot; Hypersensitivity; Livedo reticularis; Pruritus; Sensation of heaviness; Urticaria	FLU3~PFIZER\WYETH~4018057~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0181718	02/26/2002	WY	48.0	48		F	12/12/2001	Arm tender on 12/6/01 and 12/7/01. Then on 12/8/01, felt flu-like symptoms with runny nose, slight sore throat and achy (neck especially). On 12/9/01, symptoms continued but by 12/10/01, noticed stiffness in left arm. That night it was very stiff. On 12/11/01, the symptoms decreased (general) but left arm stiffness increased, back of shoulder area. Difficult to lift arm.				Y					Y	12/05/2001	12/08/2001	3	NONE	PUB	UNK	NONE	NONE	NONE		WY0203	1						1	Influenza like illness; Injection site pain; Musculoskeletal stiffness; Neck pain; Pain; Pharyngolaryngeal pain; Rhinorrhoea	FLU3~PFIZER\WYETH~4018040~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0181719	02/26/2002	WY	60.0	60		F	01/09/2002	Complained of pain in left upper arm, immediately post vax. Pain persisted with movement. Prescribed Prednisone taper X 1 week. States pain is better after completing Prednisone treatment. Complained of fleeting pain and weakness in right upper leg after Prednisone treatment done; also had transient muscle weakness in right lower leg. Brachial neuritis.				Y					Y	11/28/2001	11/28/2001	0		PUB	PUB	Atenolol	NONE	Fibromyalgia; Hypertension		WY0204	1						1	Injection site pain; Muscular weakness; Neuritis; Injection site hypersensitivity; Muscular weakness	FLU3~PFIZER\WYETH~4018053~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4018053~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0181720	02/26/2002	WY	75.0	75		M	01/09/2002	Complained of overall muscle aches throughout body which started about 3 days after receiving flu vaccine. It worsens after dark and causes pain and sleeplessness at noc. Treated with a 1 week course of Prednisone taper dose and now on Prednisone 1 X 1 day X 30 days and Vioxx prn. Dx'd with Polymyalgia Rheumatica. MD states that she feels that signs and symptoms are unrelated to the flu vaccine.				Y					N	11/28/2001	12/01/2001	3	Sed rate-57	PUB	PUB	Vioxx prn; Prednisone; Advil prn; Glucophage XR; ASA prn	NONE	NIDDM		WY0205	1						1	Insomnia; Polymyalgia rheumatica; Red blood cell sedimentation rate increased	FLU3~PFIZER\WYETH~4018053~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0181721	02/26/2002	WY	69.0	69		F	01/09/2002	Pt developed left upper arm pain immediately after receiving the flu vaccine. Pain persisted with movement. Doctor prescribed Prednisone taper for a week. States pain  is better with prednisone. Will be finished with the prescription on 01/14/2002.				Y					N	11/28/2001	11/28/2001	0		PUB	PUB	Prednisone; lipitor	NONE	NONE		WY0206	1						1	Pain; Injection site pain; Radiculitis brachial	FLU3~PFIZER\WYETH~4018053~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4018053~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0181729	02/26/2002	CA	34.0	43		M	01/31/2002	Complaint of left shoulder pain since immunization with flu vaccine at a flu clinic on 11/05/2001. Hurts at night, more pain with use right over deltoid tendon.									U	11/05/2001	11/07/2001	2		PUB	PUB	Flovent, Allegra, Serevent, Arbutrol	RAD	Environmental allergy; asthma		CA010143	1						1	Pain	FLU3~SANOFI PASTEUR~0682AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0181733	02/26/2002	OH	36.0	36		F	02/22/2002	Received flu shot in the morning approx. 1-1 1/2 hour later stated to feel numbness and tingling in whole body and had dizziness. No fever and no vomiting. symptoms lasted all day then gradually disappeared over 2 hours. Was fine the next day since then.									Y	12/14/2001	12/14/2001	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Dizziness; Hypoaesthesia; Paraesthesia	FLU3~SANOFI PASTEUR~0700AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0181784	02/27/2002	UT	35.0	35		M	02/06/2002	Pt noted numbness, tingling in fingers of the right hand on 01/07/2002. He visits the ER four times during the next few days after the immunizations. Admitted to the hospital on 01/13/2002. He also noted that the was unable to walk, could not open hands nor move fingers, difficulty swallowing. Pt was diagnosed with Guillian Barre syndrome.				Y	Y	5			Y	11/05/2001	01/07/2002	63	CAT scan, spinal tape, MRI of spine, neck and hand	PUB	PVT	Zoloft	NONE	Allergic to pollen		UT022501	1						1	Difficulty in walking; Dysphagia; Guillain-Barre syndrome; Hypoaesthesia; Hypokinesia; Paraesthesia	FLU3~PFIZER\WYETH~4018028~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1456K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0181819	02/28/2002	DC	37.0			M	02/19/2002	37 yo pt received a flu shot. The day after patient developed a sore throat and nasal congestion								Y			11/12/2001			UNK	UNK						1						1	Nasal congestion; Pharyngolaryngeal pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0181824	02/28/2002	CA	1.25	1	.3	F	02/12/2002	On 02/09/2002 raised mocular rash on trunk but also head, extremidies. No hives, no spots.									Y	01/29/2002	02/09/2002	11	CBC, WNL	PVT	OTH			NONE			1						1	Rash macular	DTAP~SANOFI PASTEUR~05400A~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~0601AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1521L~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0181846	03/01/2002	OH	27.0			M	01/02/2002	At approximately 7pm-arm got tight. had a cold sweat, passed out. Recovered in a few seconds. Did not see MD. nausea X 1/2 hr. Reported by his wife									Y				to get allergy testing at MD	PUB	PVT		NONE	NONE			1						1	Feeling cold; Loss of consciousness; Musculoskeletal stiffness; Nausea	FLU3~SANOFI PASTEUR~U0710AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0181856	03/01/2002	CT				U		Rapid heartbeat (only a few seconds). Only once									Y					PVT	UNK		NONE	NONE			1						1	Heart rate increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|UNK~UNKNOWN MANUFACTURER~~UNK~~~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA		Influenza
0181888	03/04/2002					F		An ASPP who rec'd from the MCA regulatory authority on 2/18/02 concerning a pt of unknown age who was hospitalized for facial palsy, altered sensation, and paraesthesia after receiving an influenza vaccine on 11/3/01. The pt also rec'd  bacillus pneumococcal vaccine on 1/12/01. In 11/01, the pt developed possible Guillain Barre Syndrome, facial palsy, paraesthesia of the limbs and feet and altered sensations on the feet leading to hospitalization in 1/02. The outcome is not known. There was insufficient information to determine the reporters causality assessment.					Y				U	11/03/2001				UNK	UNK					PJP200200153	1						1	Guillain-Barre syndrome; Paraesthesia; Paralysis; Sensory disturbance	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0181894	03/04/2002	MT	58.0	57		F	02/25/2002	About 10 hours post injection, the pt developed redness from the injection site to her elbow with moderate swelling @ injection site and very warm to touch. Redness and no swelling from 3 below injection site to elbow. symptoms lasted about 6 days. No other symptoms. No treatment other than an ice pack to swollen site  Has had this reaction for the last three years. But has gotten worse each year									Y	12/04/2000	12/04/2000	0	NONE	PUB	OTH	Premarin   .625		Possible Latex allergy			1						1	Injection site erythema; Injection site oedema	FLU3~PFIZER\WYETH~~7+~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0181896	03/04/2002	FL		71		F	02/24/2002	Imbalance-immediately after vaccine. Two hours after being in bed, pain (fierce) woke me-shoulder upper arms and wrist continues. A month later pain of shoulder and hip area began. Got worse. End of third month, legs hurt all over in am. The leg pain has ceased. Shoulder and lower back continue				Y						11/11/2001	11/11/2001	0	Subsequent to Nov 11/01, four blood tests, x-ray, bone-scan-all normal	PUB	UNK	Fossamax	diet controlled diabetes 2	NONE			1						1	Balance disorder; Myalgia; Arthralgia; Dizziness; Hypokinesia; Laboratory test abnormal; Myalgia; Pain; Polyarthritis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0181129	03/05/2002	MI	65.0	65		F	02/17/2002	Generalized hives, chills, severe itching, ear drainage with resultant ear infection, headache and tiredness, post vax. Continued rash to body. Treated with prednisone, antihistamines and ointment. Treatment continues. Antibiotics for ear infection.				Y					N	11/07/2001	11/15/2001	8	Blood work-neg; skin biopsy-neg	PVT	PVT	Premarin stopped 11/7; Multivitamin daily; ASA 81mg bid; Folic Acid 1mg qid	NONE	NONE			1						3	Ear disorder; Eye oedema; Infection; Pruritus; Skin exfoliation; Urticaria; Dermatitis; Eye discharge; Face oedema; Urticaria; Chills; Fatigue; Headache; Otitis media; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0575AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0575AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~474938~1~IM~RA~PNEUMO (PNEUMOVAX)~2|IPV~SANOFI PASTEUR~U0575AA~UNK~SC~LA~POLIO VIRUS, INACT. (POLIOVAX)~3|PPV~UNKNOWN MANUFACTURER~~1~IM~~PNEUMO (NO BRAND NAME)~3	USA	Emergency room visit	Influenza
0181896	03/05/2002	FL	72.0	71		F	02/26/2002	At 10:00, the pt received the flu shot. After sitting 5 to 10 minutes, I stood up and felt unsurefooted and odd until going to bed at 23:00. Two hours later, incredible pain woke me up, beginning with shoulders, especially down the upper arms, some in lower arms, a lot in the wrists and hands. This continued nightly. Kept it under control with Darvacet and sleep aid. On 11/13/01, a routine appt with PCP, told of shoulder pain and did strength and flexibility tests (both okay) and suggested the possibly of fibromyalgia or polymyalgia. Order blood tests. On 11/17/01, left for a 2 week trip, feeling I had aged 10 years with additional hip pain and difficulty getting out of seat. On 12/4 through 12/18/01, went for acupuncture and was told it was not frozen shoulders as it had been in 1996; nor was it tendonitis. On 12/28/01, appt with PCP who repeated strength and flexibility tests (okay). Was prescribed Metrol Dose, which knocked out all pain after the 1st day. Continued pain free until the day after the last tablet. Shoulder pain increased to painful day-time pain, with additional hip pain. On 1/23/02, MD seemed convinced that I had polymyalgia because the SMR was elevated, but few other usual symptoms. Another Metrol Dose prescribed, which again worked perfectly until the day after the last dosage. Also ordered more blood work (nml) and X-rays (mild arthritis in hips and shoulders). The pain seemed to increase daily through the body. Had to sit on 3 pillows, getting up often. Difficult to get up from a low seat. On 2/4/02, was started on 10mg, then 20mg of Prednisone. Pain seemed to increase daily. On 2/7/02, noticed unusual leg discomfort when waking. Pain increased on 2/8/02. Both legs felt odd on 2/9/02. On 2/10/02, it was hard to get out of bed, even with a Darvacet. On 2/12/02, couldn't get out of bed. Took a Darvacet and took 2 hours to get moving. On 2/13/02, leg pain mostly gone. Saw MD of Rheumatology and he ruled out the same things as my other MD and dropped me to 5mg Prednisone and ordered a bone scan (nml). On 2/23/02, shoulder pain still at night (under control with meds), still exists during the day, sometimes in just upper arms, some times in shoulder joints. Hip pain still more painful than the usual. Leg pain is gone.									N	11/11/2001	11/11/2001	0	Blood work-ruled out Rheumatoid Arthritis, Lupus but showed slightly elevated SMR rate; X-rays-mild arthritis in hips and shoulders; Bone scan-nml	OTH	PVT		NONE	NONE			1						2	Balance disorder; Myalgia; Arthralgia; Dizziness; Hypokinesia; Laboratory test abnormal; Myalgia; Pain; Polyarthritis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0181924	03/05/2002	VA	10.0	10		M		A 10 year old boy presented with a complaint of not hearing from left ear. He failed a hearing screen on that side (right is normal) and had a normal exam. ENT referral obtained and dx'd with sudden left sensorineural hearing loss. He had improvement with oral steroids but has residual drop in highest frequencies between 2000 to 8000 Hz. He has partial recovery.  F/UP report on 3/21/03: By phone conversation w/PT's mother (He has transferred out of reporting office's practice) he has regained 90% of his hearing and does have some tinnitus at times.								Y	N	10/18/2001	10/31/2001	13	Audiology evaluation with initial loss in speech and high frequencies; residual loss in highest frequencies	PVT	PVT						1						1	Aphasia; Hypoacusis; Neuropathy; Tinnitus	FLU3~SANOFI PASTEUR~U0599BA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0181927	03/05/2002	MO		0	.0	M	02/24/2002	Starting at 15-18 months of age, patient experienced developmental regression, compulsive behaviors, speech delay, pervasive developmental disorder and gross motor and sensory integrative disorders. Speech and occupational therapy began just after second birthday.									U	10/28/1998	02/01/2000	461	Mercury toxicity verified on hair and blood testing	PVT	OTH	NONE	NONE	NONE			1						1	Drug level increased; Mental retardation severity unspecified; Neurodevelopmental disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder	HEP~UNKNOWN MANUFACTURER~~1~IM~~HEP B (NO BRAND NAME)~1|DTAP~PFIZER\WYETH~457788~2~IM~LL~DTAP (ACEL-IMUNE)~2|HIBV~PFIZER\WYETH~423203A~2~IM~LL~HIB (HIBTITER)~2|IPV~SANOFI PASTEUR~N1061~2~IM~RL~POLIO VIRUS, INACT. (POLIOVAX)~2|RV~PFIZER\WYETH~4988048~2~PO~MO~ROTAVIRUS (ROTASHIELD)~2|DTAP~PFIZER\WYETH~457794~3~IM~LL~DTAP (ACEL-IMUNE)~3|HEP~GLAXOSMITHKLINE BIOLOGICALS~294172~3~IM~RL~HEP B (ENGERIX-B)~3|HIBV~PFIZER\WYETH~402203A~3~IM~LL~HIB (HIBTITER)~3|RV~PFIZER\WYETH~4988064~3~PO~MO~ROTAVIRUS (ROTASHIELD)~3|FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~4|HIBV~PFIZER\WYETH~406103A~4~IM~RL~HIB (HIBTITER)~4|MMR~MERCK & CO. INC.~0946J~1~IM~~MEASLES + MUMPS + RUBELLA (MMR II)~4|DTAP~PFIZER\WYETH~457794~4~IM~LL~DTAP (ACEL-IMUNE)~5|VARCEL~MERCK & CO. INC.~13404~1~IM~RL~VARICELLA (VARIVAX)~5|PNC~PFIZER\WYETH~471210~1~IM~LL~PNEUMO (PREVNAR)~6|PNC~PFIZER\WYETH~471655~2~IM~LL~PNEUMO (PREVNAR)~7	USA		Influenza
0181930	03/05/2002	NJ	68.0	68		M	02/07/2002	11/01/01 -After flu shot, Arm swollen & sore; 11/02/01 - Left gym early, Tired, Could not run, Legs weak while playing raquetball, 11/02/01 - 12/31/01- Became progressive tired, Been taking naps (which was unusual) + calves start bothering him; About 12/15 -12/31 Pins and needles in hands and feet, By 12/24, tingling sensation in hands and feet which became very strong by 12/25/01; 12/24/01 - Tired,Legs felt heavy, Calves felt sore; 12/25/01 - Tired, Calves sore + a little swollen, Funny tingling sensation in hands & feet; 12/26/02 -Tired, Slept long in early AM, Very restless sleep, Tingling in hands and feet intensive, Calves still sore & slighty swollen, Not walking very well, Pain in calves when walking, Restless sleep at night; 12/28/01 - 11:45 AM appt with family Dr, Could hardly walk, Tingling very bad in hands and foot, Dr did physical and took x-rays, All seems normal, Dr you was baffled; 12/29/01 - Could not stand with walker, Began falling resorted to crawling, which was painful, Could not sleep on either side of body, Could not sleep - very uncomfortable all nite and morning tried to get up kept falling; 12/30/01 - Could not stand alone or with walker, could not crawl - all too painful, Calves very swallow, Called on-call dr, Suggest waiting until next day to see our dr or to come into emergency room, Had a very bad night; 12/31/01 - called dr's office, Wanted to have him come in office, Pt's legs and hands immobile (Paralysis) Neighbors carried him into car and took him the the emergency room, Did another physical, catscan, MRI's & other tests, Did a spinal tap that revealed Guillain-Barre syndrome; 12/31/01 - Admitted to critical care unit, There for 5 days, then moved to neurological unit, Did intravesous immunoglobulin in critical care + other tests; 01/14/02 - 12/23/02 - Moved to rehabilitation center for care & physical & occupational therapy; 12/23/02 - discharged from rehabilitation center; 03/25/02-03/26/02 Did physical & occupational therapy for 2 hours/day for 2 days a week. 60 day follow up states pt has not recovered. Ambulation is still a problem. May 2002 he recovered his fine motor skills. Continues to have difficulty using his arms . 02/23/2002 pt discharged . Awaiting a return call from MD. MD will inform of discharge details. MD treating physician while pt was in rehab. 95% improved. 04/17/2003 difficulty with fine motor coordination Annual follow up states as of 04/17/2003 Spoke to MD treating physician. MD states that the pt continues to have difficulty with his fine motor coordination, but has shown 95% improvement.			Y	Y	Y	14			N	11/01/2001	12/01/2001	30	CSF-positive for Guillain-Barre	PUB	PUB	Lipitor	NONE			NJ200010	1						1	Abasia; Asthenia; Guillain-Barre syndrome; Lethargy; Neurodevelopmental disorder; Asthenia; Difficulty in walking; Fatigue; Guillain-Barre syndrome; Lethargy; Pain; Swelling	FLU3~SANOFI PASTEUR~U0588AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0588AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0181932	03/05/2002	CA	32.0	32		F	02/21/2002	Arm at injection site-became hard and swollen for two weeks									Y	10/30/2001	10/31/2001	1		UNK	UNK						1						1	Injection site induration; Injection site oedema	FLU3~SANOFI PASTEUR~U0592AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0181933	03/05/2002	CA	47.0	47		F	02/21/2002	The pt's right arm was very swollen, painful, red and could not lift arm over her head, the next day, post vax. Has had to have follow-up with a Neurologist. He wanted to let you know it was due to flu vaccine. Not yet recovered.				Y					N	10/30/2001	10/31/2001	1	EMG; Nerve conduction velocity test	PVT	PVT						1						1	Hypokinesia; Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U0592AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0181935	03/05/2002	CA	33.0	33		F	02/13/2002	Onset of sore throat, runny nose, body aches, malaise beginning 1 week after flu shot. fever 103 for three days, vomiting. Test for strep -negative. Red bumps on torso, peeling of hands. 10 days later progressed to ear infection. Eymin RX for ear infection.				Y					Y	02/01/2002	02/07/2002	6	Test for streps-negative	PUB	PUB	Premarin 1.25, Valium 5 mg	NONE	hysterectomy		CA020015	1						1	Malaise; Pain; Pharyngolaryngeal pain; Pyrexia; Rhinitis; Skin exfoliation; Vomiting	FLU3~SANOFI PASTEUR~U0705AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0181937	03/05/2002	NJ	31.0	31		F	02/26/2002	97.1 temp-131/82=BP, 80=R, localized redness, slight swelling-c/o itching upper L arm from flu shot.									Y	02/26/2002	02/26/2002	0	NONE	MIL	MIL	PPD	NONE	Sensitive to latex, strawberries, bananas			1						1	Injection site erythema; Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~SANOFI PASTEUR~U0869AA~5~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0181938	03/05/2002	MI	82.0	82		U		Blisters formed on personal part of body, legs and arms in five hours after shot, Kept itching all nite was unable to sleep . Went to emergency in am.									N	10/24/2001				PVT	UNK		NONE				1						1	Blister; Pruritus	FLU3~SANOFI PASTEUR~U0575AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0181940	03/05/2002	MI	41.0	40		F	03/01/2002	Severe myalgias and fatigue for 6 weeks, requiring the use of analgesics and muscle relaxants.				Y					N	11/06/2001	11/20/2001	14	CBC, Sedimentation Rate, CPK, liver and kidney panels-all nml	PUB	PUB	Singulair; Advair; Atrovent inhalers; Proventil as needed	NONE	Asthma; Allergies to MSG, Erythromycin and strawberries			1						1	Fatigue; Myalgia	FLU3~EVANS VACCINES~E083412A~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0178686	03/06/2002	IL	45.0	43		F	02/15/2002	We were first contacted by the pt on 11/28/01 and made aware of her illness. At that time, she requested a copy of the Flu vaccination consent sheet she had signed. She contacted me again in February requesting that an adverse reaction be reported. Events, as they were related to me by the pt on 2/25/02 at 12:00. On 12/5/00, the pt received vaccination. She complained of sinus congestion, cold symptoms and low-grade temperature at night. On 12/7/00, visit to PMD with above complaints as well as a rash to back of neck (noted prior to vaccination). Prescribed desoximetasone 0.25% cream and amantadine 100mg cap. On 12/11/00, no better and MD prescribed Biaxin 500mg. On 12/13/00, visit to PMD; no better and no further treatment. On 12/18/00, visit to PMD; CXR and Lab work ordered. Checking for Mono or pneumonia. Levaquin 500mg ordered. On 12/19/00; trimethobenzamide 200 mg supp. ordered. Vomiting from 12/15 to 12/19. On 12/19/00, went to ER after using suppository and having black/tarry stools. Transferred to another hospital early AM on the 20th when test showed kidneys had shut down. On 12/22/00, kidney biopsy and dx'd with Goodpastures's Syndrome. Dialysis required. On 1/10/02, had a kidney transplant. On 2/25/02, doing well. Making plans to return to work. *F/UP report on 3/31/03: Continues on anti reaction meds following kidney transplant. Returned to work. The discharge summary states weakness, glomerulonephritis, acute renal failure, pulmonary edema, respiratory failure, anemia, and vomiting.			Y	Y	Y				Y	12/05/2000	12/07/2000	2	CXR; lab work; kidney biopsy	OTH	OTH	Allegra; Pulmicort tubular inhaler	sinus congestion, low grade fever, cold symptoms	Allergy to mold and penicillin, sinusitis, depression, respiratory infection			1						3	Blood creatine phosphokinase increased; Blood urea increased; Glomerulonephritis; Immunoglobulins increased; Nasal congestion; Pain; Pyrexia; Renal failure; Vomiting; Anaemia; Apnoea; Asthenia; Faeces discoloured; Glomerulonephritis; Goodpasture's syndrome; Pharyngitis; Pulmonary oedema; Pyrexia; Rash; Renal failure; Renal failure acute; Sinus congestion; Vomiting	FLU3~AVENTIS PASTEUR~U0422AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~AVENTIS PASTEUR~U0422AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Life Threatening,Hospitalisation	Influenza
0182001	03/06/2002					M	10/10/2002	On 11/20/01, the pt exhibited brachial plexus palsy, 12 days after receiving the Flurvirin vaccine. The pt had received previous Influenza vaccinations but it is unknown if Fluvirin was administered. It is unknown if this developed on the same arm as the site of the Fluvirin injection. At the time of this report, the pt had not recovered. The reporter assessed the relationship of the study medication to the event as possible. Following internal medical review on 2/20/02, this case was upgraded to Serious. OMIC								Y	N	11/08/2001	11/24/2001	16		UNK	UNK	Aspirin; Multivitamins; Vitamin E				PJP200100466	1						1	Radial nerve palsy	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0182018	03/06/2002	CA	61.0	60		F	02/27/2002	It was reported that a 61 year old female pt received a Fluzone SV '01-'02 vaccination on 10/3/01. The pt was hospitalized on 12/7/01 for 12 days with a dx of transient brain swelling. The pt fully recovered.					Y	12			Y	10/03/2001	12/07/2001	65		UNK	UNK					U200200133	1						1	Brain oedema	FLU3~SANOFI PASTEUR~U0598AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0182032	03/06/2002	DC	28.0			M	02/28/2002	A few hours after receiving the flu vaccine, the pt began experiencing slurred speech and lightheadedness. These symptoms increased in occurance and severity over several weeks. He was evaluated and the symptoms have lessened but still occur.				Y					N	12/05/2001	12/05/2001	0		PVT	PVT	NONE	NONE	NONE			1						1	Dizziness; Dysarthria	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0182034	03/06/2002	IA	83.0	83		F	02/22/2002	Pt's daughter in law reports that the pt went to friend's home after the shots. She sat in chair in a stupor, after awhile states, I don't feel well. She got up from the chair, unsteady gait-drove herself home. Noticed confusion and forgetfulness. On 10/31/2001 being treated for acute diagnosis, first contact with pt since injections. Pt did not report any reaction to injections and is still suffering from demantia.									U	10/24/2001	10/24/2001	0		PVT	PUB	Norvase, Lasix, Amitrityline	NONE	Diabetes Mellitus			1						1	Confusional state; Dementia; Gait disturbance; Memory impairment; Stupor	FLU3~EVANS VACCINES~05211KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1067K~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0182035	03/06/2002	CA	82.0			M	02/27/2002	The report states scratching at ankles, arms and body like it was from poison ivy.									N		11/17/2001			MIL	OTH	Prozac	NONE	ulcer (2000)			1						1	Pruritus	FLUX~UNKNOWN MANUFACTURER~0702AA~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0182036	03/06/2002	MI	70.0	69		M	02/28/2002	Rash, swelling, eruptions and itching on head, neck underarms, hands, feet and groin area. Went to ER at 2am and left at 8am. On 11/30/2001, IV given antihistamine, antibiotic, saline and glucose.				Y					Y	11/26/2001	11/30/2001	4		PVT	OTH						1						1	Pruritus; Rash; Swelling	FLUX~UNKNOWN MANUFACTURER~0575AA~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0182039	03/06/2002	OK	61.0	61		M	03/04/2002	Pt complained of pain at injection site over an hour after the injection. No swelling or redness noted. pt says it hurts when moving his right arm.									U	03/04/2002	03/04/2002	0	NONE	OTH	OTH	Motrin		arthritis, COPD, smoker			1						1	Hypokinesia; Injection site pain	FLU3~SANOFI PASTEUR~0699AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1387L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0182085	03/06/2002	MO	57.0	57		F	02/04/2002	Case information amplified due to additional info from ENT seeing patient. Since date of report, pt has been advised she will probably not regain full hearing in left er. Additional history is tht she had sudden olfactory loss 9 years ago, thought to be sequel to viral infection. She relates problems of attempting to stay on Prednisone 80 mg x 2 weeks; dose reduced by pt w Drs knowledge. She also needed Toprol to control blood presure elevation provoked by steroid use. Pt feels she has made some improvement but still finds background noise helpful in ignoring the persisting noise she hears.  Follow up 10/07/2002: Patient reported that she was on Prednisone for approximately 8 weeks as recommended by her physician (name of a physician's assistant provided).  She experienced many adverse effects from the Prednisone - specifically high blood pressure to the point she required medication.  At her last visit to the ENT specialist.  There was an improvement to her hearing in the left ear.  However, there is still significant hearing loss and the ringing continues.  Her physician told her that full recovery of hearing is not possible.  Information has not been medically confirmed.				Y					N	11/07/2001	11/14/2001	7		OTH	PUB	Lipitor, Tricor, Premarin, Claritin, Toprol	NONE	hyperlipidemia, HTN			1						1	Hearing impaired	FLU3~SANOFI PASTEUR~0677AA~5~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0182117	03/08/2002	CA	34.0	34		F	05/16/2001	The pt had quarter-sized raised area of erythema at injection site about 1 hours, post vax, according to pt. She had a headache and occipital visual loss and congestion. MRI on 11/24/99 is consistent with ADEM. Treated with steroids. This is an addendum to the original form that I sent in on this pt on 5/16/01. It has been brought to my attention that the vaccine lot number (10163AA) written by me, may have been a misinterpretation of the actual number. The injection was given at another healthcare facility and I have been unable to talk to the nurse who actually gave the injection, to determine which of these numbers is correct. Discharge summary states brain lesion.				Y	Y			Y	N	11/11/1999	11/24/1999	13	CSF-(+) IgM index; MRI-ADEM	PVT	OTH	UNK	NONE	Migraine, asthma			1						1	CSF test abnormal; Encephalitis; Headache; Injection site erythema; Multiple sclerosis; Nasal congestion; Nuclear magnetic resonance imaging brain abnormal; Visual disturbance	FLU3~CONNAUGHT LABORATORIES~UO163AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0182120	03/08/2002		81.0			M		A report was received on 28 February 2002 concerning an 81-year old male patient who was hospitalized for COPD exacerbation on the same day he received Fluvirin vaccine, on 04 November 1998.  The causality was stated to be possibly related. No further information was provided.					Y		Y			11/04/1998	11/04/1998	0		UNK	UNK	Concomitant drugs not reported				PJP200200171	1						1	Lung disorder	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0182121	03/08/2002		77.0			M		A report was received on 28 February 2002 concerning a 77 year old male patient who experienced exacerbation of chronic obstructive pulmonary disease 8 days after receiving Fluvirin vaccine, on 29 October 1998 The event was considered medically important. No further information was provided. The causality was stated to be possibly related.										10/29/1998	11/06/1998	8		UNK	UNK	Concomitant drugs not reported				PJP200200175	1						1	Lung disorder	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0182136	03/08/2002	MI	49.0	49		F	02/08/2002	Client reports vaccines on 11/21/01 at 10:30 AM followed by slight headache, sore arm and felt tired. On 11/22/01, client reports she awoke at 02:30 with choking, very sore and swollen throat and positional apnea. Client states she took an antihistamine and improved in 1 1/2 hours.									Y	11/21/2001	11/22/2001	1	NONE	PUB	UNK	NONE	NONE	General environmental allergies and cats		MI2002019	1						1	Apnoea; Choking; Fatigue; Headache; Injection site pain; Pharyngeal oedema; Pharyngolaryngeal pain	FLU3~PFIZER\WYETH~4018033~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~SMITHKLINE BEECHAM~5239A4~UNK~IM~RA~HEP B (ENGERIX-B)~1|IPV~SANOFI PASTEUR~T13102~UNK~SC~RA~POLIO VIRUS, INACT. (POLIOVAX)~1|TYP~SANOFI PASTEUR~R14074~UNK~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0182147	03/11/2002		73.0			M		A report received on 2/28/02, is concerning a 73 year old male pt who experienced life-threatening tracheobronchitis, for which he was hospitalized, 3 days after receiving Fluvirin vaccine, on 10/20/1998. The pt died subsequently. It is unclear from the report what the cause of death was. The causality was stated to be possibly related. No further information was provided.	Y		Y		Y		Y		N	10/20/1998	10/23/1998	3		UNK	UNK					PJP200200178	1						1	Tracheobronchitis	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0182160	03/11/2002	CA	54.5	64		M	02/27/2002	The 54.5 year old male pt developed vertigo and vomiting. After brain tumor surgery 8 week coma with meningitis, stroke sepsis, respiratory and kidney failure, permanent residuals-gait ataxia, peripheral nerve damage, bronchiectasis with ehmophysis episodes, speech and swallowing difficulties, hypotension after meals, hearing and vision damage. Per follow up letter pt did not recover. Galt ataxia, chronic bronchitis, partial swallowing paralysis. Very disapponited in how my original report was handled. The interviewer was either blindly bias or severly handicapped by lack of training as an interviewer. This is being made just in case the VAERS program is not the sham it appears to be. From top to bottom, CDC and HHS should be overlooked so as not to appear to be anothe PAC for the pharmaceutical industry.			Y	Y	Y	165	Y	Y	N	01/15/1999	01/16/1999	1	x-rays, blood tests, CT's MRI's, Ultra sound.	PVT	UNK	NONE	chronic bronchitis, Herpes simplex	Brain tumor, bronchitis			1						1	Bronchiectasis; Bronchitis chronic; Central nervous system neoplasm; Coma; Coordination abnormal; Dysphagia; Hearing impaired; Hypotension; Meningitis; Nerve injury; Renal failure; Respiratory failure; Sepsis; Speech disorder; Vertigo; Visual acuity reduced; Vomiting	FLU3~MEDEVA PHARMA, LTD.~20178HB~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1339H~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0182163	03/11/2002		73.0			M		A report was received on 2/28/02, concerning a 73 year old male pt who was hospitalized for pneumonia, 1 month after receiving Fluvirin vaccine, on 11/12/98. The event was considered serious. The causality was stated to be possibly related. No further information was provided.					Y		Y		U	11/12/1998	12/12/1998	30		UNK	UNK					PJP200200176	1						1	Pneumonia	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0182166	03/11/2002	WI	37.0	37		F	10/25/2001	Pt called clinic at 3:00 pm-10/25/01 to report neck was swollen-(the middle of neck) had awakened this morning, coughing and founds neck to be swollen-breathing ok-swelling seemed to get worse.  Patient sent Immediate Care  Follow up:  02/26/2002: Since 10/25/01 unable to reach patient, no phone, moved.  Patient has appointment schedule to see how it went to immediate on ER.  Patient did not.  Patient here today for physical.  Patient did not pursue treatment of swollen neck, never any problem breathing.  Symptoms went away over night.    2/26/02-since 10/25/2001-unable to reach pt-no phone and moved. Pt was checked per appt. schedule to see if went to Immediate Care or ER. Pt did not. Pt here today for physical. reports did not pressure  treatment of swollen neck. Never any problem breathing. Symptoms went away over night.				Y					U	10/24/2001	10/25/2001	1		PVT	UNK	Zupresa, Insulin, Serzone,, Cbnipin	NONE	Haldol allergy			1						1	Oedema	FLU3~SANOFI PASTEUR~U0691AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0182192	03/11/2002		77.0			M		A report was received on 02/28/2002, concerning a 77 year old male pt who experienced shortness of breath 2 days after receiving Fluvirin vaccine on 10/09/1998. The event was considered medically important. The causality was stated to be possibly related. No further info was provided.									U	10/09/1998	10/11/1998	2		OTH	OTH	NONE				PJP200200173	1						1	Dyspnoea	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0182193	03/11/2002	TX	51.0			M	03/03/2002	Report describes rash in a 51 year old male who received hep a vaccine (havrix). The vaccinee's allergies were not specified. prior to vaccination with havrix, the vaccinee had experienced similar rash episodes without etiology. concomitant vaccines:typhoid and flu. On 02/23/2001, the vaccinee received his first dose of Havrix, and a dose of typhoid vaccine and flu vaccine. Four days later, on 02/27/2001, he developed a raised rash, firm with nodules and clusters on hands and feet and legs. As of 03/02/2001, the outcome of the event is unknown.									U	02/23/2001	02/27/2001	4		OTH	OTH					20010058471	1						1	Rash; Skin nodule	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~SMITHKLINE BEECHAM~~1~~~HEP A (HAVRIX)~1|TYP~UNKNOWN MANUFACTURER~~1~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0182221	03/12/2002	PA	47.0	47		M	03/06/2002	It was reported that a 47 year old male pt received a Fluzone SV vaccination on 10/19/2001 at a hospital. Reportedly 6 weeks later, the pt developed cognitive changes and had flu-like illness at end of December. On 01/21/2002, pt was admitted to intensive care unit at hospital. The reported diagnosis was acute disseminating encephalomyelitis(ADEM), unresolved, pt remains hospitalized.				Y	Y				N	10/19/2001				PVT	UNK					U200200157	1						1	Encephalitis; Influenza like illness	FLU3~SANOFI PASTEUR~0599BA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0182223	03/12/2002	KY	14.0			F	03/06/2002	A female 14 years and 11 months of age, was admitted to a local hospital because of ataxia and increasing lethargy. She had been treated since the age of 2 with carbamazepine for partial complex seizures. During the first 8 years of treatment, there were 23 measurements of serum carbamazepine had remained constant since she was 9 years of age. Because of persistent seizures at 13 years of age, gabapentin was added to her treatment program. The addition of gabapentin was associated with a decrease in seizure frequency of serum carbamazepine levels remained stable (range-8.2-12.4 ug/mL). During routine follow-up, 3 months before admission, seizures were well controlled. Weight was stable at 46.5kg and a serum carbamazepine level was 12.4. The child was continued on Tegretol XR 400mg in the AM and 600mg at night plus gabapentin 600mg 3 X daily. Thirteen days before hospitalization, the pt received the inactivated influenza vaccine Fluzone. The vaccine was well tolerated and no changes were made in the child's medication. On the day of admission, the child awoke, complained of nausea and subsequently vomited. She became dizzy and slept for 3 hours. On awakening, she was unsteady and had slurred speech. She became lethargic and poorly responsive. In the local ER, her serum carbamazepine level was 27.5 ug/mL and a urine drug screen was (+) for tricyclic antidepressants and cocaine. Tests of liver function were nml. The pt was intubated, transferred to an ICU and maintained on a ventilator for 19 hours. She received IV fluids and activated charcoal. Nine hours, after admission, her carbamazepine level was 24.5 ug/mL and levels continued to fall over the remainder of the hospitalization. A serum carbamazepine level, 4 days after admission was 9.1 ug/mL. At her last follow-up, 7 months later, the pt was seizure free and asymptomatic on her former dose of carbamazepine and gabapentin.					Y				Y				Urine drug screen-(+) tricyclic antidepressants and cocaine and this test was repeated 2 more times and both follow-up samples were (+) for tricyclic antidepressants but were (-) for cocaine; liver function studies were nml	UNK	UNK			Partial complex seizures since the age of 2		U200200167	1						1	Coordination abnormal; Dizziness; Drug level increased; Drug toxicity; Dysarthria; Hypoxia; Lethargy; Nausea; Vomiting	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0182228	03/12/2002	MD	57.0	57		F	03/11/2002	Pt complained of headache and respiratory distress and then soon went coma per her husband on 12/20/01 and impaired consciousness and speech at the end of February. Final dx: viral encephalitis.			Y	Y	Y		Y	Y	U	10/06/2001	12/20/2001	75	Spinal Tap; Blood cultures for numerous bacteria/viruses-all neg	UNK	UNK	Darvocet N; Premarin; Levbid; Soma; Zoloft; Ditropan; colchicine;Bumex; Slow-K; Calcet; Naldolol; Saligen; Prevacid; Ambien; Aldactone; Multi-Vitamin Pack; Zyrtec; Diflucan; Lortab; Imitrex of Opium; Flonase		Allergic to Lactose; Septra; Biaxin; Sulfa; Cipro; Miacalcin (headaches); Ceclor; Mycine; Floxin; clindamycin; PCN; Doxycycline; Cephalexin; Surgeries include T & A; deviated septum; ganglion cyst; Cadlwell-LUC; Othognethic (mouth/jaw); hysterectomy with bladder tuck; submandibular gland; Triumph I port-Rt; Calarect (L & R); sinus rebuild; YAG laser (L & R eyes); Port (Triumph I) left chest; viral gastritis with dehydration; interseal; Fx left hip (pinned x 3); colitis; headaches; fibromyalgia & extreme cramping; Behcet's Syndrome; aphthous ulcers (gastric, vaginal, oral); Shortness of breath; Reynaud's Disease; Deep vein thrombosis; Diabetes (med induced, ok now); peripheral neuropathy; Cellulitis R leg; RSD both feet; osteomyelitis			1						1	Depressed level of consciousness; Encephalitis; Headache; Respiratory distress; Speech disorder; Coma; Encephalitis; Respiratory distress; Speech disorder	FLU3~SANOFI PASTEUR~U0590AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~693A6~UNK~IM~LA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~T1310~UNK~SC~RA~POLIO VIRUS, INACT. (POLIOVAX)~1|TYP~SANOFI PASTEUR~R14072~UNK~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|FLU3~SANOFI PASTEUR~U0590AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~GLAXOSMITHKLINE BIOLOGICALS~693A6~UNK~IM~LA~HEP A (HAVRIX)~2|IPV~SANOFI PASTEUR~T1310~UNK~SC~RA~POLIO VIRUS, INACT. (POLIOVAX)~2|TYP~SANOFI PASTEUR~R14072~UNK~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0182229	03/12/2002		75.0			M		On 10/30/01, the pt received Fluvirin into his left upper arm and 3 day later, on 11/2/01, the pt experienced an inability to move his right arm and right leg for 70 minutes. The pt's right arm and leg went numb also. The reporter indicated that the reaction involved persistent or significant disability or incapacity, due to the numbness and paralysis of the right arm and leg. The pt recovered on the same day. There was insufficient information to determine the reporter's causality assessment.								Y	Y	10/30/2001	11/02/2001	3		UNK	UNK	Aspirin; Atenolol; Suscard; Benurofluazide; simvastatin				PJP200200185	1						1	Hypoaesthesia; Paralysis	FLU3~EVANS VACCINES~760705~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0182230	03/12/2002		62.0			M		A report was received on 02/28/2002, concerning a 62 year old male pt who experienced respiratory distress which involved or prolonged hospitalization on 10/22/1998 after receiving fluvirin vaccine on 10/08/1998. It is not known if the pt had recovered at the time of reporting the event. The reporter has assessed the causality as possibly related. No more info was provided.					Y		Y		U	10/08/1998	10/22/1998	14		UNK	UNK	NONE				PJP200200172	1						1	Respiratory distress	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0182235	03/12/2002		85.0			M	10/10/2002	A report received on 10/30/2001, concerning an 85 year old male pt who experienced pneumonia which was considered to be medically significant, 1 day after receiving the fluvirin vaccine on 10/04/2001. relevent concomitant medications taken include bisoprolol fumarate and leuprorelin acstate. On 10/05/2001, the patient experienced pneumonia, which was considered to be medically significant 1 day after receiving the fluvirin vaccine on 10/04/2001. The pt has recovered without sequelae. There was insufficient info to determine the reporter's causality assessment. Follow-up report received on 02/28/2002 indicated that the pt was diagnosed with left sided lobar pneumonia, viral. There were no results of investigations documented. The pt had a history of prostatic carcinoma. The pt was treated with levofloxacin and augmentin for the event. OMIC									Y	10/04/2001	10/05/2001	1		OTH	OTH	Emcor, Prostap 3, bisoprolol fumarate, leuprorelin acetate.		prostatic carcinoma		PJP200100343	1						1	Pneumonia	FLUX~UNKNOWN MANUFACTURER~760190~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0182271	03/13/2002		60.0			M		The pt received a Fluvirin vaccination on 10/23/98 and on 5/29/99 experienced pneumonia and respiratory failure and subsequently died, as a result the adverse event was considered serious. The reporter assessed the causality as possibly related. No more information has been provided.	Y								N	10/23/1998	05/29/1999	218		UNK	UNK					PJP200200177	1						1	Pneumonia; Respiratory failure	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0182273	03/13/2002	NY	21.0	21		F	02/28/2002	Muscle soreness, edema, rash left upper arm, diagnosis- upper arm cellulitis, left				Y					Y	10/25/2001	10/26/2001	1	CBC WBC 23000-rest WNL	PVT	PVT	NONE		splenectomy 1987			1						1	Cellulitis; Myalgia; Oedema; Rash	FLU3~EVANS VACCINES~E0052321KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~SMITHKLINE BEECHAM~5204A2~1~IM~RA~HEP B (ENGERIX-B)~1|MEN~SANOFI PASTEUR~UA303AA~1~IM~LA~MENINGOCOCCAL (MENOMUNE)~1|PPV~MERCK & CO. INC.~1071K~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0182277	03/13/2002	CO	33.0	32		F		Swollen , hives, itchness all over body. Hives all over. Has retained over 40 lbs of water since shot was given on 30 Oct 01. ER visit 3 Nov 01			Y						Y	10/30/2001	10/31/2001	1		MIL	MIL	albuterol inhaler	NONE	asthmatic			1						1	Pruritus; Swelling; Urticaria	FLU3~SANOFI PASTEUR~U0674AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0182279	03/13/2002	TX	41.0	41		F	02/24/2002	Pt presented to medical squandron c/o large amount of swelling on right upper arm where she received her typhoid immunization. Also with four scratch-like marks above swollen area, approximately 3 inches long									Y	02/24/2002	02/24/2002	0	NONE	MIL	MIL	Naprosyn, DMC	NONE	NONE			1						1	Oedema	FLU3~SANOFI PASTEUR~U0674AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~SANOFI PASTEUR~T12292~6~~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0182281	03/13/2002		29.0	29		M	03/01/2002	I have developed skin rashes that reoccur on a regular basis. I received my first anthrax shot on 10/21/1999 and continued the series that ended with shot 4 on 04/25/2000. My rashes began shortly there after on my torso, neck, back and arms along with soreness, swelling, itching at the site of injection.				Y					N	10/21/1999	09/01/2000	316	NONE	MIL	MIL	NONE	NONE	allergic to codeine			1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Rash	ANTH~EMERGENT BIOSOLUTIONS~FAV024~5~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0182282	03/13/2002		75.0			M		A health professional form was received on 02/28/2002 concerning a 75 year old male pt who experienced exacerbation of chronic obstructive pulmonary disease, which was considered medically significant 4 days after receiving a flvirin injection on 12/01/1998. The pt experienced exacerbation of chronic obstructive pulmonary disease on 12/05/1998 after receiving a fluvirin vaccine on 12/01/1998. The reporter assessed the causality as possibly related. No more information has been provided.									U	12/01/1998	12/05/1998	4		OTH	OTH	NONE				PJP200200179	1						1	Lung disorder	FLU3~MEDEVA PHARMA, LTD.~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0182425	03/14/2002	WA	21.0	20		M	02/25/2002	Within 10 minutes of receiving flu shot, the pt experienced itching at the injection site and over abdomen. Approx. 2 hours later, the pt had a racing heart rate of 160 and hot flashes. Aid car was called and pt was transported to ER. He complained of pain and tingling on left side of head. Currently he is experiencing heart arrhythmia. He continued to experience cardiac arrhythmia.				Y					N	11/09/2001	11/09/2001	0	Blood tests; EKG; CAT Scan of head	OTH	PVT		Chronic fatigue syndrome				1						1	Arrhythmia; Headache; Heart rate increased; Hot flush; Injection site reaction; Paraesthesia; Pruritus	FLU3~SANOFI PASTEUR~U0691AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0182432	03/14/2002	MD	19.0	19		F	03/08/2002	Light-headed, numbness all over shaky, patient monitored at office for about 2 hours, first time for flu vaccine									Y	12/18/2001	12/18/2001	0		PVT	UNK						1						1	Dizziness; Hypoaesthesia; Tremor	FLU3~SANOFI PASTEUR~U0727AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0182434	03/14/2002	NC	29.0	29		F	01/23/2002	Rash started with 1 small red spot on left arm, increased in size and pruritis developed. Over course of next 2 weeks, pinpoint size raised red rash developed into rash over entire body except neck and head. Rash consisted of vesicles and some rash areas 3 cm in size with dark scaly centers. Rash extremely pruritic. The patient was referred to MD. Placed on Zyrtec, Prednisone and cream for rash, but rash continued to progress and remained quite pruritic then saw dermatologist for skin bx 12/13. By 12/14/01, pruritis decreased and no further progression of rash.				Y					Y	11/19/2001	11/23/2001	4	12/13/01 skin bx for possible erythema multiform but bx was (-) per patient; bloodwork at MD office; final dx by md: allergic rxn triggered by flu vaccine.	PUB	PUB	NONE	NONE	NONE		NC02010	1						1	Injection site hypersensitivity; Pruritus; Rash erythematous	FLU3~PFIZER\WYETH~4018024~1~SC~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0182435	03/14/2002	NC	30.0	30		F	01/24/2002	The morning after receiving vaccine, the injection site was warm but not red. Afebrile. Left axilla was edematous secondary to lymph nodes swollen and tender. Had sharp pains experienced in axilla on arm movement (non-radiating). Edema worsened and saw MD on 12/14/01. Placed on Relafen. MD dx'd rxn to the flu vaccine. Pain and edema resolving by 12/18/01.				Y					Y	12/12/2001	12/13/2001	1	NONE	OTH	PUB	UNK	NONE			NC02011	1						1	Hypokinesia; Injection site warmth; Lymphadenopathy; Oedema; Pain	FLU3~PFIZER\WYETH~4018029~7+~SC~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0182500	03/15/2002		70.0			M		On 10/17/01, the pt received Fluvirin and Pneumovax II and 12 hours later, he experienced a convulsion. During this episode, the pt fell down and fractured his ankle. He was subsequently hospitalized. The pt was treated with Phenytoin for the convulsions. There was insufficient information to determine the reporter's causality assessment.					Y				U	10/17/2001	10/17/2001	0		UNK	UNK	simvastatin; ranitidine		Bladder cancer for which he had been receiving chemotherapy which was discontinued on 6/2/01; Convulsion occurred in 4/01		PJP200200182	1						1	Convulsion; Fall; Fracture	FLU3~EVANS VACCINES~760175~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~UNKNOWN MANUFACTURER~HN48490~UNK~IM~~PNEUMO (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0182501	03/15/2002		25.0	20		M		A report was received from a regulatory authority on 3/6/02, concerning a 25 year old male pt who had been enrolled in a (non-company clinical trial) who experienced vertigo, which was considered disabling after receiving a Fluvirin vaccine on 10/20/95 which (was not part of the clinical trial). The pt (a helicopter pilot) had received adsorbed tetanus-diphtheria vaccine (reduced dose) and a poliomyelitis booster on 9/26/95. Since 2/01, the pt had experienced paroxymal vertigo approx. once a week, lasting between 30 seconds and a minute. A full exam was performed which was normal, including ENT/neurological and psychiatric assessment and MRI evoked potentials. Further investigations are planned to rule out migraine. At the time of reporting, the pt had not yet recovered. There was insufficient information to determine the reporter's causality assessment.								Y	N	10/20/1995	02/01/2001	1931	MRI; ENT/neurological/psychiatric assessments	UNK	UNK			Bilateral otitis in 1/95 which was treated with amoxicillin from 1/20/95 to 2/15/95		PJP200200197	1						1	Vertigo	FLU3~MEDEVA PHARMA, LTD.~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0182603	03/19/2002	MO	69.0	69		M	05/23/2002	This report states that on 03/11/2002 a 69 year old male pt received a Fluzone SV '01-'02 vaccination administered on 10/29/2001 in his left arm. Nine to ten weeks later the pt developed pain in his left arm-had surger in Feb 2002 for pinched nerve. The pt was seen by a physician and was given a diagnosis of Parsonage-turner Syndrome. From follow up received at manufacturer on 5/10/02 additional pt history and lab results.				Y					U	10/29/2001			2/2/02 CBC abnormal: platelets 113,000 low (140-400 expected. Neutrophils 82-high (42-75 expected). Lymphocytes 12 low (21-51 expected). CT cerval spine and multiplanar reconstruction on 1/11/02. History: severe neurologic deficit left upper extremity. 1/31/02 myelogra, cervical ? History-severe neurologic deficit. Findings: severe multilevel degenerative disc disease and cerival spondylosis is present. Root sleeve filling abnormalities bilaterally at C7, left greater than right at C6 and on the left at C5. Further evaluation was performed with computed tomography. 2/2/02 intraopperative lateral view of the cervical spine. History: degenerative disc disease. Findings: spondylotic changes are seen at multiple levels of the cervical spine. Postoperative diagnosis: left C5 foraminal stenosis. Procedure-left posterior C4-5 foraminotomy. Rheumatoid factor DT-results 9.9 low positive. Anti-nuclear AB-results negative. Anti-centromere AB-results negative. ESR results 2. No evidence of acute fracture or dislocation. Extensive degenerative disease of the spine.	UNK	UNK			Cancer of bladder, transitional cell. 10/1/98 experienced cramping occurring at night-pt concerned my be related to his BCG instillation and his bladder. Degenerative disk disease. Severe neurologic deficit left upper extremity. 4/5/99 CA of the bladder. Pain in both wrists and some muscle pain in his shoulders-some evidence of synovitis. 12/3/99 has a chronic thrombocytopenia which has been worked up and is stable. Medications Provachol, Duravent and Celebrex for shoulder and arm discomfort. 12/29/99 pain mostly in the right upper arm and some in the trapezius area.		U200200178	1						1	Pain	FLU3~SANOFI PASTEUR~U0696BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0182605	03/19/2002	NJ	98.0	98		F	03/15/2002	A nurse reported that a 98 year old female resident in a long-term care facility received a dose of Flu Shield '01-'02 on 11/17/01. In 1/02, the resident developed a severe respiratory infection characterized by congestion and fever. On 1/22/02, a dx of influenza A was confirmed by rapid antigen testing. She was treated with Tamiflu (oseltamivir phosphate) and Tylenol (acetaminophen). According to the reporter, the pt was responding to these interventions. However, on 1/26/02, the pt died. The pt's physician indicated that the cause of death was myocardial infarction secondary to coronary artery disease. The physician didn't think her death was flu-related but noted that influenza may have been a contributory factor but not the primary cause of death. This is 1 of 8 residents from this facility who experienced adverse events following receipt of Flu Shield '01-'02 (lot 4018038); however, this is the only pt who died. The reporter also noted that 7 employees of the facility experienced adverse events following receipt of Flu Shield '01-'02 (lot 4018038).	Y	01/26/2002							N	11/17/2001	01/01/2002	45	On 1/23/02, blood chloride 97meq/L (decreased) and haemoglobin 10.5g/dL (decreased); mean cell haemoglobin 31.9pg/cell (increased) and blood thyroid stimulating hormone-pending	OTH	OTH	UNK	UNK	Agitation; Coronary artery disease NOS; Dementia of the Alzheimer's type NOS; Hypertension NOS; Hypothyroidism; Rami (unspecified) fracture NOS		HQ0814321FEB2002	1						1	Blood chloride decreased; Coronary artery disease; Haemoglobin decreased; Influenza; Myocardial infarction; Nasal congestion; Pyrexia; Respiratory tract infection	FLU3~PFIZER\WYETH~4018038~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0182609	03/19/2002	OK	7.0	7		M	02/10/2002	Pt developed breathing problems associated with asthma. He has asthma the significance of this is that he also has an egg allergy. He had the Flu vaccine last year but split into several doses.					Y	8			Y	11/09/2001	11/10/2001	1	NONE	MIL	MIL	Xopenex, advure, hydrocortisone	eczema, asthma, RAD, SAR	drug allergies, eggs, milk, soy, peanut			1						1	Respiratory disorder	FLU3~SANOFI PASTEUR~40674AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0182663	03/20/2002	NY	53.0	53		F	03/19/2002	Pt experienced low-grade fever (99.9 degrees F on oral temeperture) nausea, vomiting, dizziness and localized swelling @ left deltoid (site of pneumococcal vaccine administered 3/18/01) within hours of this injection Inadvertently previous vaccine given 5/22/01 was missed on chart. Review initially by the treating physician. Pt instructed to call 3/20.				Y					Y	03/18/2002	03/18/2002	0	Pt seen 3/17/02; stat hemoglobulin   titier WNL; BGN increased but pt ; lungs-clear; left deltoid warm and swollen; ice applied; Benadryl and Tylenol administered; Pt. alert	PVT	PUB	Avendia 9 mg PO QD	NONE	Diabetes Mellitus, type 2			1						1	Dizziness; Injection site oedema; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~40690AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0994L~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0182668	03/20/2002	IL	40.0	40		F	03/12/2002	Pt states that she had pain in her L arm radiating into her heck which began approx 2 hrs after receiving the vaccine on 10/19/01. It increased to the point of numbness in her  hand and pain radiating to her L eye, she had constant pain in arm and neck and experienced a low grade fever, 99.8-100F. She had difficulty lifting her arm She took anti-inflammatory medications (ES tylenol and on does of tylenol with codeine). She saw the doctor on 10/23/01. He felt a nerve was inflamed and prescribed Naproxen in the evening and during the day if necessary. She took on does Tuesday evening and on dose Wednesday AM but discontinued this after experiencing severe nausea. By this time she stated that the eye pain was much better and the numbness had subsided. She continued to self medicate with ES tylenol. 11/14/01 she stated she is back to normal. It got a little better each day without further treatment.				Y					Y	10/19/2001	10/19/2001	0	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Eye pain; Hypoaesthesia; Injection site inflammation; Injection site pain; Neck pain; Pyrexia	FLU3~EVANS VACCINES~EO4861KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0182676	03/20/2002	OH	43.0	43		M	03/13/2002	Approx. 17 hours post vaccination, the pt noted numbness in right arm down to middle of right thumb. This increased to include occasional coldness and numbness of whole thumb, occasional tingles of right arm. Saw a physician on 11/05/2001 and was given muscle relaxer. On 11/08/2001 he felt numbness had decreased slightly.				Y					U	10/22/2001	10/23/2001	1		OTH	PVT	Multivitamins, Zestoril, Glyburide, Tricor, Glucophage	NONE	Diabetes type 2			1						1	Feeling cold; Hypoaesthesia; Paraesthesia	FLU3~EVANS VACCINES~04861KA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0182713	03/21/2002	GU	36.0	36		M	03/07/2002	Received TD on 03/05, on 03/06 he developed body aches, subjective fevers and chills without an obvious source. Area of immunization with 2cm induration and tenderness.				Y					U	03/05/2002	03/06/2002	1		MIL	MIL	NONE	NONE	NONE			1						1	Chills; Injection site hypersensitivity; Injection site induration; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEA~MERCK & CO. INC.~0711L~UNK~~~MEASLES (ATTENUVAX)~1	USA	Emergency room visit	Influenza
0182738	03/22/2002	ME	28.0	28		F	03/15/2002	Immunized on the right deltoid on 03/14/2002 and noticed numbness, pain within 12 hrs of immunization. Numbness and tingling to right hand persists into 2nd 24 hours.				Y					N	03/14/2002	03/15/2002	1	NONE	OTH	PUB	Trilevern, Atavan PRN	NONE	asthma, allergy			1						1	Hypoaesthesia; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~00676AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0182228	03/25/2002	MD	57.0	57		F	03/15/2002	It was reported that a female pt (age not specified) received her 1st injection of Havrix and injections of IPOL, Fluzone and an unspecified vaccine on 10/6/01. On 12/20/01, 2.5 months, post vax, the pt developed encephalitis, which required hospitalization. As of 1/7/02, the outcome of the event was unknown. From follow-up correspondence received on 3/14/02, it was reported that the pt received the Fluzone, the IPOL, the Havrix and a Typhim VI vaccination on 10/6/01 (not 10/4/01 as previously reported). The adverse event onset date was reported as 12/20/01, not in 1/02 as previously reported. Reported the pt also experienced respiratory distress and was in a coma. The pt regained consciousness and speech at the end of 2/02. Pt is currently still hospitalized. It is unknown at this point, if these events will result in permanent disability for the pt. Final dx: viral encephalitis thought to be unrelated to immunizations.			Y		Y		Y		U	10/06/2001	12/20/2001	75	Spinal Tap; blood cultures (for numerous bacterial and viral organisms)-all neg	PVT	PVT	Darvocet N; Premarin; Levbid; Soma; Zoloft; Ditropan XL; Colchicine; Burnex; Slow-K; nadolol; Saligen; Prevacid; Ambien; Aldactone; Multi-Vitamin Pack; Miracle Mouth Wash; Zyrtec; Diflucan; Lortab; Imitrex or Midrin; Tincture of Opium; Flon		Colitis; Headaches; Chronic sinus disease; Fibromyalgia (& extremity cramping); Behcet's syndrome; Sjogren's syndrome; Esophageal Varices; Cirrhosis & Fibrosis (Hep w/unk etiology); Aphthous ulcers (gastric, vaginal, oral); Bronchiectasis & SOB; Cellulitis right leg (6/98); Baylor; Deep Vein Thrombosis; Diabetes (Med Induced; OK now); Peripheral Neuropathy (8/98); Duodenal ulcer (5/99); Osteopenia; Fracture left hip (12/17/99); RSD both feet; Osteomyelitis (L. F. sinus); Allergies to Lactose; Septra; Biaxin; Sulfa; Cipro; Miacalcin (headaches); Ceclor; Mycins; Floxin; clindamycin PCN (desensitized 9/95); Doxycycline Cephalexin (day 9-itching-OK with Atarax)		U200200045	1						2	Depressed level of consciousness; Encephalitis; Headache; Respiratory distress; Speech disorder; Coma; Encephalitis; Respiratory distress; Speech disorder	FLU3~SANOFI PASTEUR~U0590AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~693A6~UNK~IM~LA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~T1310~UNK~SC~RA~POLIO VIRUS, INACT. (POLIOVAX)~1|TYP~SANOFI PASTEUR~R14072~UNK~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|FLU3~SANOFI PASTEUR~U0590AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~GLAXOSMITHKLINE BIOLOGICALS~693A6~UNK~IM~LA~HEP A (HAVRIX)~2|IPV~SANOFI PASTEUR~T1310~UNK~SC~RA~POLIO VIRUS, INACT. (POLIOVAX)~2|TYP~SANOFI PASTEUR~R14072~UNK~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~2	USA	Life Threatening,Hospitalisation	Influenza
0182776	03/25/2002	NM	65.0	65		M	01/09/2002	Flu shot given on 12/04/2001. Pt has been experiencing muscle soreness to left shoulder and back once a month.										12/04/2001	12/05/2001	1		PVT	PUB		NONE			NM010302	1						1	Myalgia	FLU3~PFIZER\WYETH~18026~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~1~~~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0182777	03/25/2002	NM	43.0			F	01/10/2002	Leg swollen, inflammed area of 6x12, resp. difficulty and tightness of chest.				Y					Y	01/09/2002	01/19/2002	10		OTH	PUB		Upper respiratory infection	Allergic to codeine, asthma		NM010202	1						1	Chest discomfort; Dyspnoea; Inflammation; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~2~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~SMITHKLINE BEECHAM~3203A4~2~~RA~HEP B (ENGERIX-B)~1|HEPA~UNKNOWN MANUFACTURER~671A4~2~~LA~HEP A (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0182780	03/25/2002	KY	57.0	56		M	03/18/2002	Pain at injection site onset less than 12 hrs post vaccination. Pain lasted 3-4 weeks. No fever, no redness and no swelling. Was seen in ER 2 weeks after injection and diagnosed with cervicalgia (neck and right arm pain).				Y					Y	11/19/2001	11/19/2001	0		OTH	PUB		NONE	Allergic to Prevacid, Fexoterad ine, hypertension, GERD, Lumbago			1						1	Injection site pain	FLU3~SANOFI PASTEUR~0701AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0182781	03/25/2002	IL	46.0	46		F	03/21/2002	Redness, soreness at injection site; no fever, shaking, chills, and no evidence of cellulitis.									Y	10/26/2001	10/29/2001	3	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Injection site erythema; Injection site pain; Injection site erythema; Injection site pain; Injection site reaction	FLU3~SANOFI PASTEUR~0593AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0593AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0182782	03/25/2002	IL				U		Redness and soreness at the injection site, afebrile, 1.5 cm local reaction.									Y	10/26/2001	10/26/2001	0	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Injection site erythema; Injection site pain; Injection site reaction	FLU3~SANOFI PASTEUR~0593AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0182787	03/25/2002	NM	33.0	33		F	12/03/2001	Pt developed intense pruritis/urticaria. Treated with Benadryl then Tagamet.				Y					Y	11/29/2001	12/01/2001	2	NONE	OTH	OTH		NONE	allergic to pcn and bug bites		NM120101	1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~0588A~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~SMITHKLINE BEECHAM~204A4~1~IM~LA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~1153~UNK~SC~LA~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0182807	03/26/2002	WI	74.0	74		M	03/15/2002	The pt had lower back pain, difficulty walking and weight bearing. He did not have further complaints per daughter. Dx'd by Neurologist with Guillain-Barre Syndrome. The discharge summary states deep vein thrombosis, pulmonary embolism, and quadraparesis. A 60-day follow up report received 6/26/2003 adds: His muscles are approximately 80% of what they were before his 7 month hospitalization.				Y	Y	65	Y		N	12/17/2001	01/01/2002	15	Diagnostic testing; plasmapheresis; IG; Cellsept	PUB	PUB	UNK	NONE	Penicillin allergy, coronary artery disease, spinal stenosis			1						1	Back pain; Deep vein thrombosis; Difficulty in walking; Guillain-Barre syndrome; Paralysis; Pulmonary embolism	FLU3~PFIZER\WYETH~4018043~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0182873	03/27/2002	UT	68.0	68		F	01/15/2002	Pt developed complete paralysis and she was hospitalized for a month with physical therapy and one month in a nursing home for paralysis treatment. The discharge summary states GBS, and congestive heart failure. Annual follow up states right and left foot totally numb up to the ankle. No individual toe movement on either foot. Unable to walk properly. Contracted Guillian-Barre Syndrome after receiving the flu shot and has the above symptoms since then.			Y	Y	Y	30		Y	N	11/10/1998	01/02/1999	53		PVT	OTH	Lanoxin, Lasix KCl, Gliburide coumadin	NONE	Lymphoma, diabetes mellitus, pulmonary embolisn, depression, acute rrenal failure.			1						1	Abasia; Cardiac failure; Guillain-Barre syndrome; Hypoaesthesia; Paralysis	FLUX~UNKNOWN MANUFACTURER~9978180~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0182876	03/27/2002	NY	50.0	50		F	11/20/2001	Glassy eyes, hoarseness, vertigo and severe headaches.									Y	11/07/2001	11/08/2001	1	NONE	PVT	OTH	Norvasack, Phenobabital, Zestril, Normidyne	NONE	Hypertension, systemic lupus erythematosus			1						1	Dysphonia; Headache; Staring; Vertigo	FLU3~PFIZER\WYETH~4018023~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0182879	03/27/2002	NY	43.0	43		F	11/20/2001	Sore arm, vertigo, double vision, muscles aches, pains, nausea, severe headache									Y	11/18/2001	11/19/2001	1	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Diplopia; Headache; Myalgia; Nausea; Pain; Vertigo	FLU3~PFIZER\WYETH~4018023~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0183096	03/28/2002	GA	3.0			M	03/28/2002	the person named above sent a comment to the FDA stating that my 3 year old daughter received her first flu shot on Thursday Nov 15th, 2001 around 10AM.  On monday Nov 19th, 2001 I noticed a change in her mood and she complained that her head hurt.  I took her temp anfter feeling her body and noticed she was very hot.  This fever lasted about 3 days and she was treated with Tylenol.  On Monday Dec 17th after 11am she received her second flu shot.  On Thursday Dec 20th she complained that her head hurt, her body was hot and i treated her with Tylenol for 3 days.  The temp that i recorded was on Sat 12/22/01 2:13AM, 101.9; 4:22am, 100.9; 11:28am, 100.7.  Prior to the vaccine, she was fine.  I feel that the vacc caused some type of reaction despite the fact that I did not notice and/or take her temp for 3-4 days after the vacc was given.  She could have very well had a fever prior to her temp being taken.									Y	11/15/2001	11/19/2001	4	none mentioned	UNK	UNK	not mentioned	none	not mentioned			1						1	Headache; Mood altered; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0182951	03/29/2002	IL	37.0	36		F	03/12/2002	Pt was w/o neurologic symptoms until 12/1/01, when she recalls experiencing a funny lightheaded sensation and headache following a drill she was performing for Army Reserve training. She ret'd home and improved w/rest but subsequently noticed that when she was taking a shower and doing other activities, she would become lightheaded and dizzy and feel as though she might faint. Symptoms persissted and limited her ability to do her normal physical exercise regimen. Denies any antecedent illness but did receive flu shot on 11/15/01. She also describes a one-year history of mild headaches. Two weeks ago she began to experience numbness and tingling in her hands and feet. Initially occured only at night and then began to occur during the day. She had episodes where she had unusual paresthesias extending into the face and scalp area. Does not find any connection between her neurologic symptoms and the findings on her MRI scan of the brain. Discussed w/her treatment of her paresthesias with Ultram or Neurontin.  Diagnosed with orthostasis and sensory symptoms.				Y					N	11/15/2001	12/01/2001	16	The spinal tap results showed no abnormal protein levels in the fluid; MRI of brain abnormal due to cerebellar atrophy.	OTH	PVT	hydrochlorothiozide, Singulair, Monopril, Vanceril inhaler	NONE	asthma, mild hypertension			1						1	Cerebral atrophy; Dizziness; Headache; Hypoaesthesia; Orthostatic hypotension; Paraesthesia	FLU3~EVANS VACCINES~E09871LA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0182955	03/29/2002	VA	5.0	5		F	03/26/2002	Pt noted rash on arms around 8:23om on 03/21/2002. On 03/23/2002 at 10pm, reports rash from shoulder to forearm. Spoke with MD and was advised to take Benadryl. Rash persisted into 03/24/2002 and repeated with Benadryl.									Y	03/21/2002	03/23/2002	2		PVT	PVT	Claritin	NONE	Allergic to pcn			1						1	Rash	FLU3~SANOFI PASTEUR~U0675BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1212L~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0182957	03/29/2002			55		F		A report was received from a health professional on 01/03/2002, concerning a 55 year old female pt who experienced persistent pain in her left arm and shoulder, 2 to 3 days after receiving Fluvirin on 11/15/2001. The pt has a medical history of hypertension, hyperlipidemia and myocardial infarction and was receiving ramipril, metoprolol succinate, atorvastatin, provella-14, multivitamins and acetylsalicylic acid concomitantly. It is unknown whether or not the pt had received an influenza vaccine previously. On 11/15/2001, the pt received a fluvirin injection into her left deltoid muscle. Two to three days later the pt experienced pain in her left arm and shoulder, which was treated with meloxicam. The pt however, is sill experiencing pain in her left arm and shoulder, although the symptoms are milder. The reporter has assessed the relationship of study medication to the event as probable. Following internal review on 03/18/2002, this event was upgraded to serious.									U	11/15/2001	11/17/2001	2		OTH	OTH	Altace, Toprol HL, Lipitor, Presmerc, Multivitamin, Ecotrin				PJP200200100	1						1	Arthralgia; Shoulder pain	FLUX~UNKNOWN MANUFACTURER~E2781NA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0183046	04/02/2002					F	10/17/2001	Area of injection of flu vaccine became reddened and itchy Approximately 20-30 minutes post receiving med. Within 24 hours arm had increased redness, itching. Worse on 10/16. Hot to touch. Improved on 10/17/01									U		10/14/2001			UNK	UNK			allergic to codeine			1						1	Injection site erythema; Injection site hypersensitivity; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U0615BA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0183047	04/02/2002	WI	38.0	38		F	12/19/2001	Pain, swelling, tenderness to bilateral axilla for 5 days and chills lasted 12 hours.				Y					U	11/12/2001	11/12/2001	0	NONE	UNK	UNK						1						1	Chills; Injection site hypersensitivity; Injection site oedema; Injection site pain; Injection site reaction	FLU3~SANOFI PASTEUR~UO672AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0183052	04/02/2002	WA	3.5	1	.0	M		Pt developed Varicella zoster. Two years post immunization. Not culturd to verify whether W. lol tyle vs vaccine. Normal course of illness.				Y					Y	11/03/1999	03/21/2002	869	NONE	PVT	PUB		NONE				1						1	Drug ineffective; Herpes zoster	FLU3~CONNAUGHT LABORATORIES~Uo130AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~CONNAUGHT LABORATORIES~N1142AA~3~~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0926J~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0183091	04/02/2002		14.0			F	03/11/2002	The pt was treated with Tegretol-XR since the age of 2 yrs for partial complex seizure. Serum carbamazepine levels ranged from 4.1-13.5ug/ml. Gabazentine was added to the Tx program, which resulted in a decrease in seizure frequency. 13 days before hospitalization the pt rec'd the inactivated influenza vaccine Fluzone. On the day of admission, 13 days after vaccination the child awoke, complained of nausea and subsequently vomited. She became dizzy and slept for 3 hrs. On awakening, she was unsteady and had slurred speech. She became lethargic and poorly responsive. In  the local ER her serum carbamazepine level was 27.5ug/ml and a urine drug screen was positive for tricyclic antidepressants and cocaine. The pt was intubated, rec'd IV fluids and activated charcoal. 9 hrs after admission her carbamazepine level was 2405ug/ml, and levels continued to fall over the remainder of the hospitalization. A serum carbamazepine level 4 days after admission, was 9.1ug/ml. At her last follow up 7 months later, the pt was seizure free and asymptomatic on her former dose of carbamazepine and gabapentin. The authors considered that the influenza vaccination caused a depression of the P-450 isoenzymes which resulted in a significant rise in serum level and the observed carbamazepine toxicity. Drug toxicity NOS, drug interaction, dysarthria					Y								urine drug screen - positive for tricyclic antidepressants and cocaine.	UNK	UNK	Gabapentin				PHBS2002USA03016	1						1	Dizziness; Drug toxicity; Dysarthria; Gait disturbance; Laboratory test abnormal; Lethargy; Nausea; Vomiting	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0183092	04/02/2002	OK	43.0			M	02/26/2002	A pt with a history of depression treated with Paxil, with no family history of  Parkinson's like disorders initiated PEG-INTRON 120 MCG QWK SC and rebetol 1200 MG QD PO on 8/3/01 for the treatment of hepatitis C. It was noted that while on treatment the pt was administered a flu vaccine (exact date and specifics unknown). On 11/27/01, the pt appeared ataxic, weak and unsteady, almost parkinson-like only with more extreme spasticity. The pt also complained of no appetite, PEG-INTRON dose was decreased to 80mcg QWK and Rebetol to 800mg QD, The pt's condition worsened, he was unable to get around, sometimes only with the aid of a cane. Treatment was discontinued on 12/3/01. On 12/25/01, the pt exhibited an episode of extreme anxiety and anger and was hospitalized in a psychiatric ward for 5 days (specifics not provided). As of 2/26/2. the pt's condition had not improved and he was scheduled for an appointment with a neurologist in 3/02. Further info was requested.					Y						11/27/2001			UNK	UNK	Paxil, PEG-INTRON, REBETOL		Depression, hepatitis C		2002021967	1						1	Anger; Anorexia; Anxiety; Asthenia; Balance disorder; Coordination abnormal; Muscle spasticity	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0183106	04/03/2002	WA	44.0	44		F	03/28/2002	Started warm painful right arm noticed, painful to left arm up painful to touch, ached all over but is resolving now.									Y	03/25/2002	03/25/2002	0	NONE	OTH	PUB		Upper Resp. Infecton	Fibramyalgia, IBS (irritable bowel syndrome), asthma			1						1	Injection site hypersensitivity; Injection site pain; Pain	FLUX~UNKNOWN MANUFACTURER~4018029~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~1050L~1~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0183107	04/03/2002	NY	35.0	35		M	11/17/2001	After giving pt meningococcal he developed an immediate localized wheal at place of SQ injection in right arm. Pt lungs clear no wheezing noted. Noted a reduction in wheal in 20 mins. Was observed until 10 am area less than 2.									Y	11/17/2001	11/17/2001	0		MIL	MIL		NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U0674AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~SANOFI PASTEUR~UB058AA~1~SC~RA~MENINGOCOCCAL (MENOMUNE)~1	USA		Influenza
0183149	04/04/2002	NV	54.0	54		F	03/27/2002	It was reported that a 54 year old female pt received a fluzone vaccination administered in October 2001. The pt reports now having pneumonia two times, cracked lips, and a low grade fever since vaccination.									U	10/01/2001				UNK	UNK					U200200221	1						1	Dry skin; Pneumonia; Pyrexia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0183151	04/04/2002	CA	49.0	49		F	03/28/2002	It was reported that a 49 year old female pt received fluzone unspecified vaccination on 11/03/2000. Reportedly in November 2000 the pt experienced a muscle injury, rotator cuff syndrome, injection site reaction and injection site pain. The pt was hospitalized for surgery. The pt has recovered.					Y				Y	11/03/2000	11/03/2000	0		UNK	UNK					U200200228	1						1	Injection site pain; Injection site reaction; Injury; Rotator cuff syndrome	FLU3~AVENTIS PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0183167	04/04/2002	AR	77.0	77		F	12/04/2001	Pt stated that yesterday (12-3-01) late night arm had red streaks appearing on lower arm than noticed swelling came back 12-4-01 @ 8:30. To be seen today. Had redness and swelling on upper right arm associated with pain. Pt received pneumovax yesterday (12-3-01). Pt was seen 12-4-01 by doctor. Treatment: Claritin 10 mg and Medrol dose pack. Was treated today.				Y						12/03/2001	12/03/2001	0	NONE	OTH	UNK			Penicillin		AR0214	1						1	Cellulitis; Injection site pain; Injection site swelling	FLU3~PFIZER\WYETH~4018029~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1160L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0181927	04/08/2002	MO	3.0	0	.3	M	02/24/2002	Starting at 15-18 months of age, the pt experienced developmental regression, compulsive behaviors, speech delay, pervasive developmental disorder and gross motor and sensory integrative disorders. Speech and occupational therapy began just after his 2nd birthday.									U	02/16/1999	02/01/2000	350	Mercury toxicity verified on hair and blood testing	PVT	OTH	NONE	NONE	NONE			1						2	Drug level increased; Mental retardation severity unspecified; Neurodevelopmental disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder	HEP~UNKNOWN MANUFACTURER~~1~IM~~HEP B (NO BRAND NAME)~1|DTAP~PFIZER\WYETH~457788~2~IM~LL~DTAP (ACEL-IMUNE)~2|HIBV~PFIZER\WYETH~423203A~2~IM~LL~HIB (HIBTITER)~2|IPV~SANOFI PASTEUR~N1061~2~IM~RL~POLIO VIRUS, INACT. (POLIOVAX)~2|RV~PFIZER\WYETH~4988048~2~PO~MO~ROTAVIRUS (ROTASHIELD)~2|DTAP~PFIZER\WYETH~457794~3~IM~LL~DTAP (ACEL-IMUNE)~3|HEP~GLAXOSMITHKLINE BIOLOGICALS~294172~3~IM~RL~HEP B (ENGERIX-B)~3|HIBV~PFIZER\WYETH~402203A~3~IM~LL~HIB (HIBTITER)~3|RV~PFIZER\WYETH~4988064~3~PO~MO~ROTAVIRUS (ROTASHIELD)~3|FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~4|HIBV~PFIZER\WYETH~406103A~4~IM~RL~HIB (HIBTITER)~4|MMR~MERCK & CO. INC.~0946J~1~IM~~MEASLES + MUMPS + RUBELLA (MMR II)~4|DTAP~PFIZER\WYETH~457794~4~IM~LL~DTAP (ACEL-IMUNE)~5|VARCEL~MERCK & CO. INC.~13404~1~IM~RL~VARICELLA (VARIVAX)~5|PNC~PFIZER\WYETH~471210~1~IM~LL~PNEUMO (PREVNAR)~6|PNC~PFIZER\WYETH~471655~2~IM~LL~PNEUMO (PREVNAR)~7	USA		Influenza
0181927	04/08/2002	MO	1.5	0	.5	M	02/24/2002	Starting at 15-18 months of age, the pt experienced developmental regression, compulsive behaviors, speech delay, pervasive developmental disorder and gross motor and sensory integrative disorders. Speech and occupational therapy began just after his 2nd birthday.									U	04/20/1999	02/01/2000	287	Mercury toxicity verified on hair and blood testing	PVT	OTH	NONE	NONE	NONE			1						3	Drug level increased; Mental retardation severity unspecified; Neurodevelopmental disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder	HEP~UNKNOWN MANUFACTURER~~1~IM~~HEP B (NO BRAND NAME)~1|DTAP~PFIZER\WYETH~457788~2~IM~LL~DTAP (ACEL-IMUNE)~2|HIBV~PFIZER\WYETH~423203A~2~IM~LL~HIB (HIBTITER)~2|IPV~SANOFI PASTEUR~N1061~2~IM~RL~POLIO VIRUS, INACT. (POLIOVAX)~2|RV~PFIZER\WYETH~4988048~2~PO~MO~ROTAVIRUS (ROTASHIELD)~2|DTAP~PFIZER\WYETH~457794~3~IM~LL~DTAP (ACEL-IMUNE)~3|HEP~GLAXOSMITHKLINE BIOLOGICALS~294172~3~IM~RL~HEP B (ENGERIX-B)~3|HIBV~PFIZER\WYETH~402203A~3~IM~LL~HIB (HIBTITER)~3|RV~PFIZER\WYETH~4988064~3~PO~MO~ROTAVIRUS (ROTASHIELD)~3|FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~4|HIBV~PFIZER\WYETH~406103A~4~IM~RL~HIB (HIBTITER)~4|MMR~MERCK & CO. INC.~0946J~1~IM~~MEASLES + MUMPS + RUBELLA (MMR II)~4|DTAP~PFIZER\WYETH~457794~4~IM~LL~DTAP (ACEL-IMUNE)~5|VARCEL~MERCK & CO. INC.~13404~1~IM~RL~VARICELLA (VARIVAX)~5|PNC~PFIZER\WYETH~471210~1~IM~LL~PNEUMO (PREVNAR)~6|PNC~PFIZER\WYETH~471655~2~IM~LL~PNEUMO (PREVNAR)~7	USA		Influenza
0181927	04/08/2002	MO	1.0	1	.0	M	02/24/2002	Starting at 15-18 months of age, the pt experienced developmental regression, compulsive behaviors, speech delay, pervasive developmental disorder and gross motor and sensory integration disorders. Speech and occupational therapy began just after 2nd birthday.									U	11/04/1999	02/01/2000	89	Mercury toxicity verified on hair and blood testing	PVT	OTH	NONE	NONE	NONE			1						4	Drug level increased; Mental retardation severity unspecified; Neurodevelopmental disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder	HEP~UNKNOWN MANUFACTURER~~1~IM~~HEP B (NO BRAND NAME)~1|DTAP~PFIZER\WYETH~457788~2~IM~LL~DTAP (ACEL-IMUNE)~2|HIBV~PFIZER\WYETH~423203A~2~IM~LL~HIB (HIBTITER)~2|IPV~SANOFI PASTEUR~N1061~2~IM~RL~POLIO VIRUS, INACT. (POLIOVAX)~2|RV~PFIZER\WYETH~4988048~2~PO~MO~ROTAVIRUS (ROTASHIELD)~2|DTAP~PFIZER\WYETH~457794~3~IM~LL~DTAP (ACEL-IMUNE)~3|HEP~GLAXOSMITHKLINE BIOLOGICALS~294172~3~IM~RL~HEP B (ENGERIX-B)~3|HIBV~PFIZER\WYETH~402203A~3~IM~LL~HIB (HIBTITER)~3|RV~PFIZER\WYETH~4988064~3~PO~MO~ROTAVIRUS (ROTASHIELD)~3|FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~4|HIBV~PFIZER\WYETH~406103A~4~IM~RL~HIB (HIBTITER)~4|MMR~MERCK & CO. INC.~0946J~1~IM~~MEASLES + MUMPS + RUBELLA (MMR II)~4|DTAP~PFIZER\WYETH~457794~4~IM~LL~DTAP (ACEL-IMUNE)~5|VARCEL~MERCK & CO. INC.~13404~1~IM~RL~VARICELLA (VARIVAX)~5|PNC~PFIZER\WYETH~471210~1~IM~LL~PNEUMO (PREVNAR)~6|PNC~PFIZER\WYETH~471655~2~IM~LL~PNEUMO (PREVNAR)~7	USA		Influenza
0181927	04/08/2002	MO	1.25	1	.3	M	02/24/2002	Starting at 15-18 months of age, the pt experienced developmental regression, compulsive behaviors, speech delay, pervasive developmental disorder and gross motor and sensory integrative disorders. Speech and occupational therapy began just after 2nd birthday.									U	02/03/2000	02/01/2000		Mercury toxicity verified on hair and blood testing	PVT	OTH	NONE	NONE	NONE			1						5	Drug level increased; Mental retardation severity unspecified; Neurodevelopmental disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder	HEP~UNKNOWN MANUFACTURER~~1~IM~~HEP B (NO BRAND NAME)~1|DTAP~PFIZER\WYETH~457788~2~IM~LL~DTAP (ACEL-IMUNE)~2|HIBV~PFIZER\WYETH~423203A~2~IM~LL~HIB (HIBTITER)~2|IPV~SANOFI PASTEUR~N1061~2~IM~RL~POLIO VIRUS, INACT. (POLIOVAX)~2|RV~PFIZER\WYETH~4988048~2~PO~MO~ROTAVIRUS (ROTASHIELD)~2|DTAP~PFIZER\WYETH~457794~3~IM~LL~DTAP (ACEL-IMUNE)~3|HEP~GLAXOSMITHKLINE BIOLOGICALS~294172~3~IM~RL~HEP B (ENGERIX-B)~3|HIBV~PFIZER\WYETH~402203A~3~IM~LL~HIB (HIBTITER)~3|RV~PFIZER\WYETH~4988064~3~PO~MO~ROTAVIRUS (ROTASHIELD)~3|FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~4|HIBV~PFIZER\WYETH~406103A~4~IM~RL~HIB (HIBTITER)~4|MMR~MERCK & CO. INC.~0946J~1~IM~~MEASLES + MUMPS + RUBELLA (MMR II)~4|DTAP~PFIZER\WYETH~457794~4~IM~LL~DTAP (ACEL-IMUNE)~5|VARCEL~MERCK & CO. INC.~13404~1~IM~RL~VARICELLA (VARIVAX)~5|PNC~PFIZER\WYETH~471210~1~IM~LL~PNEUMO (PREVNAR)~6|PNC~PFIZER\WYETH~471655~2~IM~LL~PNEUMO (PREVNAR)~7	USA		Influenza
0181927	04/08/2002	MO	1.5	1	.5	M	02/24/2002	Starting at 15-18 months of age, the pt experienced developmental regression, compulsive behaviors, speech delay, pervasive developmental delay, gross motor and sensory integrative disorders. Speech and occupational therapy began at 2 years old.									U	05/11/2000	02/01/2000		Mercury toxicity verified on hair and blood tests	PVT	OTH	NONE	NONE	NONE			1						6	Drug level increased; Mental retardation severity unspecified; Neurodevelopmental disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder	HEP~UNKNOWN MANUFACTURER~~1~IM~~HEP B (NO BRAND NAME)~1|DTAP~PFIZER\WYETH~457788~2~IM~LL~DTAP (ACEL-IMUNE)~2|HIBV~PFIZER\WYETH~423203A~2~IM~LL~HIB (HIBTITER)~2|IPV~SANOFI PASTEUR~N1061~2~IM~RL~POLIO VIRUS, INACT. (POLIOVAX)~2|RV~PFIZER\WYETH~4988048~2~PO~MO~ROTAVIRUS (ROTASHIELD)~2|DTAP~PFIZER\WYETH~457794~3~IM~LL~DTAP (ACEL-IMUNE)~3|HEP~GLAXOSMITHKLINE BIOLOGICALS~294172~3~IM~RL~HEP B (ENGERIX-B)~3|HIBV~PFIZER\WYETH~402203A~3~IM~LL~HIB (HIBTITER)~3|RV~PFIZER\WYETH~4988064~3~PO~MO~ROTAVIRUS (ROTASHIELD)~3|FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~4|HIBV~PFIZER\WYETH~406103A~4~IM~RL~HIB (HIBTITER)~4|MMR~MERCK & CO. INC.~0946J~1~IM~~MEASLES + MUMPS + RUBELLA (MMR II)~4|DTAP~PFIZER\WYETH~457794~4~IM~LL~DTAP (ACEL-IMUNE)~5|VARCEL~MERCK & CO. INC.~13404~1~IM~RL~VARICELLA (VARIVAX)~5|PNC~PFIZER\WYETH~471210~1~IM~LL~PNEUMO (PREVNAR)~6|PNC~PFIZER\WYETH~471655~2~IM~LL~PNEUMO (PREVNAR)~7	USA		Influenza
0181927	04/08/2002	MO	1.9	1	1	M	02/24/2002	Starting at 15-18 months of age, the pt experienced developmental regression, compulsive behaviors, speech delay, pervasive developmental disorder, gross motor and sensory integrative disorders. Speech and occupational therapy began at 2 year old.									U	10/12/2000	02/01/2000		Mercury toxicity verified on hair and blood tests	PVT	OTH	NONE	NONE	NONE			1						7	Drug level increased; Mental retardation severity unspecified; Neurodevelopmental disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder; Abnormal behaviour; Drug toxicity; Neurodevelopmental disorder; Speech disorder	HEP~UNKNOWN MANUFACTURER~~1~IM~~HEP B (NO BRAND NAME)~1|DTAP~PFIZER\WYETH~457788~2~IM~LL~DTAP (ACEL-IMUNE)~2|HIBV~PFIZER\WYETH~423203A~2~IM~LL~HIB (HIBTITER)~2|IPV~SANOFI PASTEUR~N1061~2~IM~RL~POLIO VIRUS, INACT. (POLIOVAX)~2|RV~PFIZER\WYETH~4988048~2~PO~MO~ROTAVIRUS (ROTASHIELD)~2|DTAP~PFIZER\WYETH~457794~3~IM~LL~DTAP (ACEL-IMUNE)~3|HEP~GLAXOSMITHKLINE BIOLOGICALS~294172~3~IM~RL~HEP B (ENGERIX-B)~3|HIBV~PFIZER\WYETH~402203A~3~IM~LL~HIB (HIBTITER)~3|RV~PFIZER\WYETH~4988064~3~PO~MO~ROTAVIRUS (ROTASHIELD)~3|FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~4|HIBV~PFIZER\WYETH~406103A~4~IM~RL~HIB (HIBTITER)~4|MMR~MERCK & CO. INC.~0946J~1~IM~~MEASLES + MUMPS + RUBELLA (MMR II)~4|DTAP~PFIZER\WYETH~457794~4~IM~LL~DTAP (ACEL-IMUNE)~5|VARCEL~MERCK & CO. INC.~13404~1~IM~RL~VARICELLA (VARIVAX)~5|PNC~PFIZER\WYETH~471210~1~IM~LL~PNEUMO (PREVNAR)~6|PNC~PFIZER\WYETH~471655~2~IM~LL~PNEUMO (PREVNAR)~7	USA		Influenza
0183220	04/08/2002	MI	81.0	80		F	03/15/2002	The pt contracted Guillain Barr syndrome and was treated for three weeks at the hospital. Has been in full rehab facilities since that time. Pt is  not able to walk or sit up. On the annual report received on 04/22/2003, the reporter states, Patient is still unable to walk unassisted (uses walker). Needs assistance to dress, undress, toilet and food prep. Is homebound (90%). Has spent all savings on aides and can no longer afford them. Severe arthritis in right arm, hand, knee and ankle. Suffered hair loss due to stress.			Y		Y		Y	Y	N	11/02/2001	12/23/2001	51	Lab test confirmed GBS	PUB	UNK		NONE	Cataract removal			1						1	Alopecia; Arthritis; Difficulty in walking; Guillain-Barre syndrome	FLU3~SANOFI PASTEUR~U0575AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0183222	04/08/2002	TX	69.0	69		F	04/02/2002	Extremely rapid heart beat, very deep and constant cough; 4 degrees of fever; extreme weakness and exhaustion from 11/01 through the end of 1/02. Exhaustion easily and heart flurries inside.			Y						Y	11/20/2001			PMP ordered EKG report, but symptoms re: heart have continued on	PUB	PUB	Buspar; Armature thyroid; Claritin-D the day before vaccination	Rhinitis from allergies	Rhinitis-sinus allergy, took Claritin-D capsule the day before vaccination			1						1	Asthenia; Bundle branch block; Cough; Heart rate increased; Pyrexia	FLU3~SANOFI PASTEUR~U0682AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0183223	04/08/2002	MA	0.2	0	.2	F	04/01/2002	High fever (Temp max 103F (Ax)				Y					Y	03/26/2002	03/27/2002	1	CBC-WBC-16.6; UA-pending	PVT	PUB	NONE	NONE	RAD (Reactive Airway Disease)			1						1	Pyrexia	DTAP~SANOFI PASTEUR~U0536CA~1~IM~~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~T1446~1~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~PFIZER\WYETH~481565~1~IM~~HIB (HIBTITER)~1|PNC~PFIZER\WYETH~481544~1~IM~~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0183226	04/08/2002	TN	51.0	51		F	02/28/2002	The pt experienced soreness in her left breast and swelling in her left underarm, 24 hours later. No swelling or redness at the site of the injection but did have soreness at injection site. Swelling in her left underarm was the size of her hand. She saw her PCP whom stated that the pt had immune response (systemic).				Y					Y	02/25/2002	02/26/2002	1	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Breast pain; Injection site pain; Lymphadenopathy	FLU3~PFIZER\WYETH~4018054~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0183260	04/09/2002	ND	26.0	26		M		Acute posterior multi-focal placoid pigment epitheliopathy with minor inflammation (aseptic) meningitis; nearly complete recovery of vision.				Y	Y	1			Y	01/09/2002	01/27/2002	18	CSF-pleocytosis	UNK	UNK	NONE	NONE	NONE			1						1	Meningitis; Pigmentation disorder; Pleocytosis; Retinitis	FLU3~EVANS VACCINES~E12221MA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0183263	04/09/2002	MI	31.0	31		M	01/28/2002	Left deltoid erythema and warmth following administration on 01/27/2002.									Y	01/27/2002	01/28/2002	1		PUB	OTH						1						1	Feeling hot; Injection site erythema	FLU3~PFIZER\WYETH~4018037~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1264L~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0183268	04/09/2002	PA	0.92	0	1	M	04/03/2002	Vaccinated with Varivax on 11/29/01. Developed chicken pox on 3/30/2002									Y	11/29/2001	03/30/2002	121		PVT	PVT	NONE	NONE	NONE			1						1	Skin ulcer	FLU3~SANOFI PASTEUR~U0670AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~1826K~3~IM~~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~477171~4~IM~~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0098L~1~SC~~VARICELLA (VARIVAX)~1	USA		Influenza
0183269	04/09/2002		65.0			M		This reports concern a 65 years old male pt who experienced swollen eyes, itchy rash, swollen lips, temperature elevation and lethargy after receiving the fluvirin vaccination on 11/13/2001. On 11/13/2001, the pt received the Fluvirin vaccination and on 11/14/2001 he developed the symptoms mentioned earlier which lasted 5 days. On 11/14/2001, the pt was administered 10mg Loratadine for 7 days to treat his symptoms. The pt recovered on 11/19/2001. There was insufficient info to determine the reporter's causality assessment. Following internal review on 03/18/2002, this event was upgraded to serious.									Y	11/13/2001	11/14/2001	1		OTH	OTH	NONE				PJP200200053	1						1	Body temperature increased; Eye swelling; Lethargy; Rash pruritic; Swelling	FLUX~UNKNOWN MANUFACTURER~760846~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0183482	04/10/2002	NY	47.0	47		F	04/04/2002	Moderate swelling on the left arm from the elbow to the shoulder.  Pain in the erythematous area.  Reaction after 8 hours and lasted for 8 days.  No fever or discharge at the injection site.									Y	01/07/2002	01/07/2002	0	none	PVT	UNK	none	none	none			1						1	Erythema; Pain; Swelling	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~SMITHKLINE BEECHAM~524A2~2~IM~LA~HEP B (ENGERIX-B)~1	USA		Influenza
0183358	04/11/2002	GA				F	04/03/2002	On 4/1/02, it was reported that an adult female pt received a Fluzone SV '01-'02 vaccination (lot U0600AA) on 10/20/01. Two weeks later, she developed muscle weakness in her thighs that became progressively worse in November and December, spreading to her chest, face and neck. The pt was evaluated by a physician and had EMG and sleep apnea tests with negative results.				Y					U	10/20/2001	11/03/2001	14	EMG-neg; sleep apnea tests-neg	UNK	UNK					U200200232	1						1	Muscular weakness	FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0183365	04/11/2002	IL	47.0	47		M	12/17/2001	Pt developed brachial plexitis a few weeks following his influenza vaccine									U	11/09/2001			Neurological history and examination	MIL	UNK		NONE	NONE			1						1	Radiculitis brachial	FLU3~SANOFI PASTEUR~U0686AB~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0183412	04/12/2002	FL	83.0	83		M	03/20/2002	Pt experienced numbness and partial loss of function of lower extremities approx. two weeks following fluvax. Initially a diagnosis of Guillaine Barr syndrome was made. The pt was given IV and initially improved, but then worsened to the point he was a complete paraplegie. MRI, CT scan was suggestive of spinal tumor and fracture. Also states that he had a history of hypertension, left cva and a fib. Pt was see by his PCP on 11/1 and had no complaints of weakness or any neuro sxs. He was given flu vaccination on review of electronic notes. Pt states couple days after that appt (15-18 days) back he noted he was stumbling and getting weaker in his le. He also noted some numbness in his both feet. He continued to ambulate until last week when he had to start using wheel chair due to progressive LE weakness and truncal weakness with inability to support himself. He had several falls in the past week and came to see his PCP on 11/13 for evaluation of his LE weakness. A lumber ct spine was ordered and pt returned yesterday for the follow up. He was noted to be even weaker in his LE with complete inability to get up and transfer himself as he could even two days back. Pt's provider was advised to admit him to medicine for further work up and monitoring. Pt states his weakness has not progressed any further in the past 24 hrs since the admission. He denies any UE weakness, facial weakness, dysphagia, blurred or double vision or any breathing difficulties. NO speech impairment, dizziness, palpitations. He does report numbness in his feet and some paresthesia around his trunk and no complaints of bladder bowel impairment or incontinence.				Y	Y				U	11/01/2001	11/15/2001	14		OTH	OTH	amidodarone, chlorthalidone, diltiazem, sertraline		Hypertension			1						1	Condition aggravated; Guillain-Barre syndrome; Hypoaesthesia; Hypokinesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0183440	04/15/2002		70.0	70		F		In 10/01, the pt received Fluvirin, after which, the pt experienced a painful, burning sensation and edema in the injected arm, finding it difficult to sleep on that side. The pt then received physiotherapy and an injection of betamethasone. At the time of reporting, it was not known whether or not the pt had recovered. The reporter has assessed the relationship of Flurvirin to the event as possible.								Y	U	10/27/2001	10/27/2001	0	Echography and radiography-neg results	UNK	UNK	piacoledine (soya extract); oxaceprol; Ecazide				PJP200200237	1						1	Injection site oedema; Injection site pain; Sleep disorder	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0183601	04/17/2002	WV	18.0	17		M		CIDP; Guillain-Barre Syndrome following.								Y	N	01/01/1976	01/15/1976	14		PVT	UNK	NONE	NONE	NONE			1						1	Demyelination; Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0183603	04/17/2002	KS	50.0	50		F	04/12/2002	On 10/24/2001 injection site from flu shot red, slightly raised, itches. Pharmacist informed same day. Took Tylenol. Site was marked around area of swelling, redness. Next day, all the symptoms resolved.									Y	10/22/2001	10/24/2001	2	NONE	PVT	PVT	Prempro, Fosamax, Paxil, Prevacid	NONE	Keflex allergy			1						1	Injection site erythema; Injection site oedema; Injection site swelling	FLU3~SANOFI PASTEUR~U0590AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0183607	04/17/2002	MS	58.0	58		F	04/11/2002	Pt to ER with fever, sob started on 11/19/2001 afternoon. Congestion, headache, left arm swollen and red around injection site. Pt given Prednisone, Lortab and discharged.				Y					Y	11/19/2001	11/19/2001	0		OTH	OTH	Tylenol, Accolate, Flexeril, Albuterol prn		Bursitis right arm, smoker with lung problems			1						1	Dyspnoea; Injection site erythema; Injection site oedema; Nasal congestion; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0183656	04/18/2002	MO	21.0	20		F	10/30/2002	It was reported that a 21 year old female pt received a Typhim Vi vaccine, date not specified. The pt has been in Africa since January 2002. She was diagnosed on 4/4/2002 with malaria and typhoid. Further info is requested. From f/up #1 correspondence received at manufacturer on 8/12/02 it was reported that the patient received the Typhim VI vaccination on 11/13/01, she also received an Imovax Rabies and a Fluzone SV '01-'02 vaccination that same day. *On 11/5/01* the patient was administered a Yellow Fever vaccination and a Imovax Rabies vaccination. On 12/4/01 the patient was administered an Imovax Rabies vaccination, an IPOL vaccination and a Menomune A/C/Y/W-135 vaccination. The patient was treated with Metloquine for the Malaria. *F/UP report on 11/5/02: F/UP #2 correspondence received on 10/25/02 indicated that Fluzone SV 2001-2003 USP were administered IM in the deltoid. No further info is available since the PT was not treated at the reporting facility. This case is closed.*									U	11/13/2001	04/04/2002	142		OTH	OTH					U200200245	1						1	Drug ineffective	FLU3~SANOFI PASTEUR~U0676AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|RAB~SANOFI PASTEUR~T01612~2~IM~~RABIES (IMOVAX)~1|TYP~SANOFI PASTEUR~T10672~UNK~IM~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0183661	04/18/2002	KY	62.0	62		F	04/12/2002	Immediate severe pain, burning and throbbing sensation, followed by gradual paralysis of 1st the injected limb, then the other side, as well as her respiratory system. Pt is now on ventilator, suffering from upper body paralysis. Has permanent motor neuron disease.			Y	Y	Y			Y	N	12/13/2000	12/13/2000	0	Several ENG's and other neurological function tests	PVT	OTH		NONE				1						1	Injection site pain; Pain; Paralysis flaccid; Respiratory disorder	FLU3~SANOFI PASTEUR~V0488AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TTOX~LEDERLE LABORATORIES~466025~UNK~IM~RA~TETANUS TOXOID (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0183662	04/18/2002	NY	43.0	43		F	01/21/2002	On 12/8/01, admitted with syncope; flu vaccine 2 weeks prior; 3 days prior to admission, developed generalized myalgia, vomiting, diarrhea, fever and chills. Unable to retain fluids, no urine over 24 hours. Similar episode prior year which occurred 2 weeks after vaccine. Treatment with IV fluids, O2, IV Claforan and advised not to have the flu vaccine in the future, per contact person. Discharge diagnoses also included acute gastroenteritis and dehydration for both hospitalizations. The initial hospitalization's diagnoses also included hypovolemic shock, leukocytosis, acute renal failure, and metabolic acidosis.				Y	Y	3			Y	11/24/2001	12/05/2001	11	Initial BP-48 systolic; Temp-100.1F; Pulse-144; RR-12; BUN-30; Creatinine-3.2; Na-140, K-3.2	UNK	UNK				Acute gastroenteritis, hypokalemia, dehydration, shock and renal failure~Influenza (Seasonal) (no brand name)~~42.00~In Patient		1						1	Acidosis; Blood creatinine increased; Blood urea increased; Dehydration; Diarrhoea; Gastroenteritis; Heart rate increased; Hypokalaemia; Hypotension; Hypovolaemia; Myalgia; Pyrexia; Renal failure; Respiratory rate decreased; Shock; Syncope; Urinary retention; Vaccine positive rechallenge; Vomiting	FLU3~SANOFI PASTEUR~U0682AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0183702	04/18/2002	FL	72.0	73		F	04/15/2002	Severe pain, swelling and erythema at site of vaccination of Pneumovax booster. Known to be over 15 years since her 1st pneumovax.				Y					Y	10/05/1999	10/05/1999	0	NONE	PVT	OTH	Premarin; Paxil; Procardia; Ambien	NONE	Osteoporosis; HTN; Depression			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U0144AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~459038~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0183686	04/19/2002		30.0	30		F		A report received from a health professional on 11/05/2001, concerning a 30 year old female pt who experienced jaw pain, an injection site reaction and reduced arm movement, 3 days after receiving Fluvirin vaccine on 10/30/2001. On 11/02/2001, the pt experienced left-sided jaw pain, inflammation and pain at injection site, and reduced function of right arm, 3 days after receiving the fluvirin vaccine. At the time of this report, the injection site reaction and arm function had resolved, but the jaw pain was worsening. The pt's condition was deteriorating and she was having difficulty fully opening her jaw. The pt was treated with Analgesics, which had no effect. The pt recovered on 11/16/2001. There was insufficient info to determine the reporter's causality assessment. Followint internal review on 04/12/2002, this event was upgraded to serious.									Y	10/30/2001	10/31/2001	1		OTH	OTH	NONE				PJP200100388	1						1	Hypokinesia; Injection site inflammation; Injection site pain; Pain in jaw	FLUX~UNKNOWN MANUFACTURER~760167~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0183718	04/22/2002	PA	87.0	87		M	04/04/2002	Pt got influenza 12/01 @ family doctor. Was admitted 3/28/02 for lumbar laminectomy worked by neurosurgeon anf internist. Determined the possible reaction of post-vaccination demyelination and encephalomyelitis. Requested that Pharmacy report. The discharge summary states lumbar canal, stenosis, prostate CA, and melanoma.									N	12/01/2001	03/28/2002	117		UNK	UNK			DM, allergy			1						1	Bone disorder; Demyelination; Encephalitis; Malignant melanoma; Prostate cancer	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0183719	04/22/2002	CO	30.0	29		F	03/27/2002	Since vaccine was administered, pt has had muscle soreness originating from site of injection. Pt reports limited ROM without soreness, pain and limited strength. Pain occasionally radiates to forearm, numbness, and tingling in all fingers (rt arm). Appt with physican office on 03/25/2002.				Y					N	10/30/2001	10/30/2001	0		PUB	OTH	Birth control pills	NONE	NONE		CO02002	1						1	Hypoaesthesia; Muscular weakness; Myalgia; Paraesthesia	FLU3~SANOFI PASTEUR~U0593AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0183721	04/22/2002	NY	75.0	75		M	04/16/2002	Patient was under doctor's care for years. On October 4th, patient had an enzyme test and the numbers were low (45). He had the flu shot on October 16th. November 1st, he had stage 4 liver cancer. His enzymes were over 260. Patient died on 12/18/2001. Diagnosed at hospital with hepatomegally with liver mass, hypertention, GI bleeding/anemia. Also diagnosed with unstable angina. Pt sent to ER by MD for LUQ pain X 1 week per F/U 6/25/02 and afibrillation.	Y	12/18/2001							N	10/16/2001	11/01/2002	381	11/2/01-Glucose 147 (H); CO2-34 (H); Calcium-8.2 (L); Albumin-3.1 (L); Total bilirubin-2.0 (H); AST and ALT-109 (H) and 186 (H)RBC-3.86 (L); HGB-12.2 (L) HCT-35.2 (L); Platelets-121 (L); MPV-6.9 (L); Neutrophil-80.4 (H); Lymphocyte-8.5 (L); ESR-24 (H). On 11/1/01-BUN 30 (H); CO2-33 (H); Total bilirubin-2.1 (H); Direct bilirubin-1.0 (H); ALK phosphatase-124 (H); AST-123 (H); ALT-205 (H); RBC-3.94 (L); HGB-12.1 (L); HCT-36.0 (L); MPV-7.2 (L); SEGS-74.0 (H); Lymphocyte-7.0 (L); MONOCYTE-14.0 (H); Myelocyte-1.0 (H); PT-14.2 (H); INR-1.40 (H); PTT-22.3 (L); Lipase-151 (H); CT lung-liver is enlarged with nodules, multiple lesions compatible with metastic disease of liver; Chest PA-heart enlarged;	UNK	UNK	Lasix; Adalat; Loppressor; Lopid; MT Patch; Axid; Vioxx	NONE	Per F/U 6/25/02: heart disease, hypertension, diabetes mellitus, tuberculosis, asthma, pneumonia, bronchitis, jaundice, anemia, gall bladder disease, kidney disease, arthritis, veneral disease, mental illness, rheumatic fever			1						1	Abdominal pain upper; Alanine aminotransferase increased; Anaemia; Angina pectoris; Aspartate aminotransferase increased; Atrial fibrillation; Blood albumin decreased; Blood alkaline phosphatase increased; Blood calcium decreased; Blood glucose increased; Blood urea increased; Carbon dioxide increased; Cardiomegaly; Enzyme abnormality; Gastrointestinal haemorrhage; Haematocrit decreased; Haemoglobin decreased; Hepatic neoplasm malignant; Hepatomegaly; Hyperbilirubinaemia; Hypertension; Lymphopenia; Platelet count decreased; Red blood cell count decreased; Red blood cell sedimentation rate increased	FLUX~UNKNOWN MANUFACTURER~90659~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0183774	04/23/2002	UT	28.0	28		F	12/07/2001	Red blotchy arm with itching. Pt reports similar reaction with other vaccines. 8mg chlorphenirame given po.									Y	12/07/2001	12/07/2001	0	NONE	OTH	PVT	NONE	NONE	Several outdoor allergies			1						1	Injection site erythema; Injection site hypersensitivity; Pruritus; Rash macular	FLU3~SANOFI PASTEUR~U0711AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0183775	04/23/2002	UT	42.0	42		F	11/16/2001	5-10 mins after injection of fluzone and pneumovax. Pt complained of throat being on fire with stiffness in sinus area after BP taken complained of arm itching and burning between fingers. 8mg chlorpheneramine give 134-86. After 20 mins symptoms resolved.									Y	11/16/2001	11/16/2001	0	NONE	OTH	PVT	NONE	NONE	pcn allergy			1						1	Inflammation; Musculoskeletal stiffness; Pharyngolaryngeal pain; Pruritus	FLU3~SANOFI PASTEUR~U0711AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0802L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0183776	04/23/2002	UT	34.0	34		F	11/28/2001	itching, lightheadness, nausea and vomiting. Began at 12:10 flu shot at 11:46. Given 8mg chlorpheniramine. 13:20 pt reports vomiting -states feeling better. 13:25 8mg chlorpheniramine repeated due to vomiting.									Y	11/28/2001	11/28/2001	0		PUB	PVT	Efexir, Taprol, Welbutron	NONE	Allergic to Antivert, Augmentin, and codine.			1						1	Dizziness; Injection site hypersensitivity; Nausea; Pruritus; Vomiting	FLU3~SANOFI PASTEUR~U0711AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0183778	04/23/2002	MO	33.0	32		F	03/15/2002	Acute onset of shortness of breath and weakness. No hives or rash. Taken to the medical center. Unstable in ER with weak pulse and lethargic. Admitted to the hospital and was diagnosed pneumonia.					Y	6			Y	11/21/2001	11/23/2001	2		OTH	OTH	UNK	UNK	Latex allergy			1						1	Asthenia; Dyspnoea; Lethargy; Pneumonia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0183780	04/23/2002	MI	19.0	19		F	04/20/2002	Complained of rash behind both ears, front, neck, left arm. Rash itches slightly, scattered patches with pink papules lasted 4 days. Pt had gone in hot tub that previous weekend and had similar rash after hot tub before.									Y	02/07/2002			NONE	OTH	OTH	Desogen	NONE	NONE			1						1	Rash papular; Rash pruritic	FLU3~SANOFI PASTEUR~U0701AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~SMITHKLINE BEECHAM~711A6~UNK~IM~RA~HEP A (HAVRIX)~1|TYP~SANOFI PASTEUR~T1052~UNK~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0183890	04/25/2002	KY				F	05/20/2002	An attorney alleges that a female received an injection of Flu Shield (200-2001 formula) on or about 11/03/2000 and subsequently suffered an unspecified serious and permanent bodily injury. It is alleged that she subsequently suffered physical and mental pain, permanent bodily disfigurement, and permanent impairment of her ability to labor and earn money. No further info was available at the date of this report. The follow up states this report was determined to be a duplicate of report HQ5486904SEP2001.								Y	U	11/03/2000			UNK	OTH	OTH	UNK	UNK	UNK		HQ1939019APR2002	1						1	Emotional distress; Pain	FLU3~PFIZER\WYETH~U0421AA~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0183910	04/26/2002	CA	35.0	34		F	04/22/2002	The pt's husband reported that the pt, a 35 year old female, received a Fluzone SV '99-'00 vaccination on 11/99. Thirteen days later, the pt could not see. She was hospitalized and dx'd with DM encephalitis by a neurologist who submitted a VAERS form. The pt's husband states he is filing a lawsuit.					Y				U	11/01/1999	11/14/1999	13		UNK	UNK					U200200286	1						1	Blindness; Encephalitis	FLU3~SANOFI PASTEUR~U0163AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0183921	04/26/2002	IN	54.0	54		F	04/21/2002	The pt reports that three days after I received the I began to experience difficulty moving my left arm. I noticed the pain to be different from injection point tenderness or general muscular ache but thought it was probably just a variation of the norm. The pain increased to the point where I was barely able to abduct the arm or bear any weight and my ability to work was severely impaired. I saw my primary care physician 11/20/2001 who prescribed a nine day course pf Prednisone. That treatment gave me almost complete relief from the pain and loss of mobility. Four to five days after completing the course of Prednisone the symptoms and pain returned. The pain increased, it involved my entire shoulder and hsoulder blade area, I was not able to sleep through the night and no matter what I did I couldn't find relief. I called my primary care physician who referred me for orthopedic consultation. On 12/10/2001 the orthopod decided to retreat me with a longer course of Prenisone. Again I experienced almost full relief while on the medication, but the symptoms returned within a week of ending the medication. I did not like the side effects I had experienced on the longer course of Prednisone and since the improvement wasn't sustained, I tried to find other sources of relief from the pain. I worked with a massage therapist for over a month who subsequently advised me to return to a physician because the area was not responding to the treatment. On 02/22/2001, I returned to the orthopod who diagnosed the condition as a chemical induced neuritis and prescribed physical therapy and medication for the pain. The electric current therapy has greatly reduced the pain but I still experience swelling in my left axilla and some loss of motion. I continue to do home exercises and have regular massage therapy. I am not pain free.				Y				Y	U	11/15/2001	11/18/2001	3		PVT	PVT	NONE	NONE	NONE			1						1	Hypokinesia; Injection site oedema; Injection site pain; Injection site reaction; Neuritis; Pain; Sleep disorder	FLU3~SANOFI PASTEUR~U0678CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0183944	04/29/2002		28.0	28		M		A report was received from a consumer on 1/7/02, concerning a 28 year old male pt who experienced headaches, sore throat, tonsillitis, vomiting and numbness from the chest down, 36 hours after receiving the Fluvirin vaccine on 11/14/01, which resulted in hospitalization and disability. He also, at one point, was unable to move his right leg. 16 days, post vax, the pt was admitted to the hospital on the 11/30/01 and remained there for 3 weeks. The pt had not recovered at the time of reporting. There was insufficient information to determine the reporter's causality assessment. A follow-up report was received on 1/28/02. Further to the symptoms already noted, the pt experienced a severe reaction to the Fluvirin vaccine resulting in swelling of gums, fever, dehydration, chills (shivering) and the inability to control body temperature, tiredness and lack of energy, at the time of reporting, his vomiting meant he could not take any liquids, he suffered pins and needles/numbness all over the body below T3. His inability to move his right leg meant he could not walk for several weeks. At the time of reporting, the pt had ongoing numbness of the right leg and right side. He was dx'd with transverse myelitis. The pt was discharged from the hospital on 12/19/01. A 2nd follow-up report was received from a health professional on 4/15/02. A consultant neurologist dx'd the pt with transverse myelitis. The pt was admitted to the hospital on 12/5/01 and was discharged on 12/20/01. At the time of reporting, the pt's condition had settled to almost complete resolution but minor numbness at the front of the leg remains. The pt has no previous relevant previous history and was taking no concurrent medications at the time of the event. The reporter assessed the causality as probable.					Y	15		Y	N	11/14/2001	11/15/2001	1		UNK	UNK					PJP200200019	1						1	Abasia; Dehydration; Fatigue; Gingival hypertrophy; Headache; Hypoaesthesia; Myelitis transverse; Paralysis; Pharyngolaryngeal pain; Pyrexia; Tonsillitis; Vomiting	FLU3~EVANS VACCINES~760194~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0183952	04/29/2002	CA	67.0	67		F	04/23/2002	Right arm, neck scapula 2+ edema, redness and warmth. symptoms started on 04/22/2002 at 9pm. NO medication taken for discomfort. Prescription for Benadryl 12.5mg given. Returned to clinic on 04/25/2002 for further evaluation. Follow-up appt. on 05/22/2002 scheduled.				Y					Y	04/22/2002	04/22/2002	0	NONE	PUB	PUB	levathyroxine		Hypothyroidism, allergic to pcn			1						1	Erythema; Feeling hot; Oedema	FLU3~SANOFI PASTEUR~U0805AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~476951~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0184000	04/30/2002	CA	64.0	64		M	02/15/2002	On 02/13/2002 experienced dizziness, nausea, stomach cramps, diarrhea and headache. Went to ER and found an acute viral syndromes not due to vaccine. On 02/25/2002 left message that he was feeling well.				Y					Y	02/08/2002				PUB	OTH		NONE	Lymphoma			1						1	Abdominal pain; Diarrhoea; Dizziness; Headache; Nausea; Viral infection	FLU3~SANOFI PASTEUR~U0704AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~T0908~UNK~SC~~POLIO VIRUS, INACT. (IPOL)~1|YF~SANOFI PASTEUR~UB071AA~1~SC~LA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0181719	05/01/2002	WY	60.0	60		F	03/11/2002	A nurse reported that a 60 year old female received an injection of flu shield on 11/28/2001. Immediately after receiving the injection, she developed a sore left arm. She was treated with prednisone. She also briefly experienced weakness in her left leg after completing the prednisone. She recovered. Additional info received on 01/24/2002 indicated that she has a history of fibromyalgia and hypertension. A final diagnosis of brachial neuritis was made. The physician felt that this event was related to be flu shield vaccine administration.									Y	11/28/2001	11/28/2001	0	UNK	PUB	OTH	Atenolol	NONE	Hypertension NOS, fibromyalgia		HQ9739203JAN2002	1						2	Injection site pain; Muscular weakness; Neuritis; Injection site hypersensitivity; Muscular weakness	FLU3~PFIZER\WYETH~4018053~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4018053~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0181721	05/01/2002	WY	69.0	69		F	03/01/2002	A nurse reported that a 69 year old female received an injection of Flu Shield (2001-2002 formula) on 11/28/01. Immediately, post vax, the pt developed soreness at the injection site. The reporter indicated that 3 pts experienced this event; however, only 1 is presently identifiable. Additional reports will be generated when identifying information is provided. Follow-up information received from the reporter, indicated that the pt was seen by a physician and dx'd with brachial neuritis. She was treated with Prednisone. Additional FOLLOW-UP information received on 05/06/02 indicated that the patient recovered.				Y					Y	11/28/2001	11/28/2001	0	UNK	PUB	OTH	Lipitor	UNK	Rhinitis, seasonal		HQ9739703JAN2002	1						2	Pain; Injection site pain; Radiculitis brachial	FLU3~PFIZER\WYETH~4018053~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4018053~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0184065	05/01/2002	LA	28.0	28		F	04/24/2002	Redness, hot and induration at the injection site.				Y					U	04/23/2002	04/24/2002	1		MIL	MIL	NONE	NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site warmth	FLU3~SANOFI PASTEUR~U0686AB~5~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0518AA~2~SC~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0184111	05/01/2002	NJ				U		A nurse reported that a resident of a long-term care facility received a dose of flu shield in November 2001. In January 2002, the resident developed a severe respiratory infection characterized by congestion and fever. A rapid antigen test was negative for influenza a. The resident recovered. No further info was available at the date of this report.									Y	11/01/2001	01/01/2002	61	UNk	OTH	OTH	UNK	UNK	UNK		HQ0016822JAN2002	1						1	Respiratory tract infection	FLU3~PFIZER\WYETH~4018038~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0184112	05/01/2002	TN	51.0	51		F	02/04/2002	A 51 year old female reported that she received an injection of flu shield on 12/14/2001. Almost immediately, the pt developed pain at the injection site which resolved in 10 mins. On 12/21/2001, the pt developed swelling of both hands and achiness of her shoulders, neck and knees. The reporter described the symptoms to be like fibromyalgia. She also stated that she is only able to sleep about 1.5 hrs at a time before the pain awakens her. The pt was seen by the physician and treated with naproxen. Unspecified blood work was performed; however, results were not reported.				Y					U	12/14/2001	12/21/2001	7	UNK	OTH	PUB	Celeka, Prempro	UNK	Anxiety NEC		HQ0033922JAN2002	1						1	Arthralgia; Fibromyalgia; Injection site pain; Sleep disorder; Swelling	FLU3~PFIZER\WYETH~4018044~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0184113	05/01/2002	NJ				F	03/26/2002	A nurse reported that a female employee of a long-term care facility received a dose of flu shield in November 2001. Within 24-48 hrs, the employee developed flu-like symptoms that resolved approx. 48 hrs after onset. No further info was available at the date of this report.									Y	11/01/2001	11/02/2001	1	UNk	OTH	OTH	UNK	UNk	UNK		HQ0074323JAN2002	1						1	Influenza like illness	FLU3~PFIZER\WYETH~4018038~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0184114	05/01/2002	MN	47.0	47		F	02/04/2002	The brother-in-law of a 47 year old female reported that his sister-in-law received a dose of flu shield on 12/12/2001 and developed an injection site reaction characterized by redness and swelling 3-4 days post-vaccination. She also experienced dizziness, fluctuating blood pressure, and facial numbness. The reporter indicated that the redness and swelling at the injection site resolved; however, as of 01/22/2002, the dizziness, fluctuating blood pressure, and facial numbness persisted. NO further info was available at the date of this report.									U	12/12/2001	12/15/2001	3	UNk	OTH	OTH	Hytrin	UNK	UNK		HQ0084823JAN2002	1						1	Dizziness; Hypoaesthesia; Injection site erythema; Injection site oedema	FLU3~PFIZER\WYETH~4018036~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0184115	05/01/2002	NC	52.0	52		F	03/15/2002	A 52 year old nurse reported that on 01/25/2002, she accidentally squirted flu shield in her eyes and on her hands during administration. She immediately rinsed her eyes and hands with cold water. Follow-up info received on 03/04/2002 indicated that on 01/27/2002, she developed a sinus infection and bronchitis. The reporter noted that the events may have been a coincidence.									U	01/25/2002	01/27/2002	2	UNk	OTH	OTH	NONE	NONE	UNK		HQ0316330JAN2002	1						1	Bronchitis; Sinusitis	FLU3~PFIZER\WYETH~4018026~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0184116	05/01/2002	GA				U	02/04/2002	A nurse reported that several pts received an injection of flu shield and subsequently developed flu-like symptoms. No further info was available at the date of this report. This is 1 of four pts from this facility who had an adverse experience following receipt of flu shield. The reporter was unable to specify the number of pt who experienced this event. Additional reports will be generated when identifying info is provided.									U				UNk	OTH	OTH	UNk	UNK	UNK		HQ0408501FEB2002	1						1	Influenza like illness	FLU3~PFIZER\WYETH~4018032~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0184117	05/01/2002	IL	27.0	27		M	03/26/2002	A healthcare professional reported that her 27 year old son received an injection of flu shield on 10/31/2001. Concomitant therapy included Propecia and Flovent. approximately two weeks post-vaccination, the pt developed a cold. Sometime in November 2001, the pt travelled twice by air, and after air travel experienced some transient hearing loss and dizziness. The pt was seen by a physician who made a diagnosis of vertigo. He was treated with Bonine and exercises. The reporter indicated that as of the date of this report, the dizziness had not improved. No further info was available at the time of this report.				Y					U	10/31/2001	11/01/2001	1	UNk	PUB	OTH	Flovent, Propecia	UNK	UNK		132491	1						1	Dizziness; Hearing impaired; Pharyngitis; Rhinitis; Vertigo	FLU3~PFIZER\WYETH~i~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0184118	05/01/2002	NJ				U		A nurse reported that a resident of a long-term care facility received a dose of flu shield in November 2001. In January 2002, the pt developed a severe respiratory infection characterized by congestion and fever. A rapid antigen test was negative for influenza A. The resident recovered. No further info was available at the date of this report.									Y	11/01/2001	01/01/2002	61	UNK	OTH	OTH	UNK	UNK	UNK		HQ1332114MAR2002	1						1	Nasal congestion; Pyrexia; Upper respiratory tract infection	FLU3~PFIZER\WYETH~4018038~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0184119	05/01/2002	NJ				U		A nurse reported that a resident of a long-term care facility received a dose of flu shield in November 2001. In January 2002, the resident developed a severe respiratory infection characterized by congestion and fever. A rapid antigen test was negative for influenza A. The resident recovered. No further info was available at the date of this report.									Y	11/01/2001	01/01/2002	61	UNk	OTH	OTH	UNK	UNK	UNK		HQ1332214MAR2002	1						1	Pyrexia; Respiratory tract infection; Upper respiratory tract infection	FLU3~PFIZER\WYETH~4018038~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0184120	05/01/2002	NJ				F	03/26/2002	A nurse reported that a female employee of a long-term facility received a dose of flu shield in November 2001. Within 24-48 hrs, the employee developed flu-like symptoms that resolved approx. 48 hrs after onset. No further info was available at the date of this report.									Y	11/01/2001	11/03/2001	2	UNk	OTH	OTH	UNK	UNK	UNK		HQ1333115MAR2002	1						1	Influenza like illness; Injection site hypersensitivity; Injection site inflammation; Injection site warmth; Pruritus	FLU3~PFIZER\WYETH~4018038~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4018038~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0184120	05/01/2002	NJ				U	03/26/2002	A nurse reported that an employee of a long-term care facility received a dose of Flu Shield (2001-2002 formula) in 11/01. Within 24-48 hours, the employee developed a local reaction characterized by inflammation, warmth and itching at the site of Flu Shield administration. The symptoms resolved approx. 48 hours after onset. No further information was available at the date of this report. This is 1 of 7 employees of this facility who experienced adverse events following receipt of Flu Shield (2001-2002 formula) lot 4018038. The reporter also indicated that 8 residents of the facility experienced adverse events following receipt of Flu Shield (2001-2002 formula) lot 4018038.									Y	11/01/2001	11/01/2001	0	UNK	OTH	OTH	UNK	UNK	UNK		HQ0851421FEB2002	1						2	Influenza like illness; Injection site hypersensitivity; Injection site inflammation; Injection site warmth; Pruritus	FLU3~PFIZER\WYETH~4018038~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4018038~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0184121	05/01/2002	NJ				U	03/26/2002	A nurse reported that an employee of a long-term care facility received a dose of flu shield in November 2001. Within 24-48 hrs, the employee developed flu-like symptoms that resolved approx 48 hrs after onset. No further info was available at the date of this report.									Y	11/01/2001	11/03/2001	2	UNK	OTH	OTH	UNK	UNK	UNK		HQ1333215MAR2002	1						1	Influenza like illness	FLU3~PFIZER\WYETH~4018038~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0184122	05/01/2002	NJ				U	03/26/2002	A nurse reported that an employee of a long-term care facility received a dose of flu shield in November 2001. Within 24-48 hrs, the employee developed flu-like symptoms that resolved approx 48 hrs after onset. No further info was available at the date of this report.									Y	11/01/2001	11/03/2002	367	UNK	OTH	OTH	UNK	UNK	UNK		HQ1333315MAR2002	1						1	Influenza like illness	FLU3~PFIZER\WYETH~4018038~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0184123	05/01/2002	NJ				U	03/26/2002	A nurse reported that employee of a long-term care facility received a dose of flu shield in November 2001. Within 24-48 hrs, the employee developed flu-like symptoms that resolved approx. 48 hrs after onset. No further info was available at the date of this report.									Y	11/01/2001	11/03/2001	2	UNk	OTH	OTH	UNK	UNK	UNK		HQ1333415MAR2002	1						1	Influenza like illness	FLU3~PFIZER\WYETH~4018038~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0184124	05/01/2002	OR				F	03/26/2002	A medical assistant reported that on 03/11/2002, a female inadvertently received an intradermal injection of flu shield. The reporter indicated that the person administering the product thought it was for use in TB testing. Five minutes post-vaccination, she developed an injection site reaction characterized by redness, swelling, and itching. She was treated with hydrocortisone cream. No further info was available at the date of this report.									U	03/11/2002	03/11/2002	0	UNK	OTH	OTH	UNK	UNK	UNK		HQ1342015MAR2002	1						1	Injection site erythema; Injection site hypersensitivity; Injection site oedema; Injection site reaction; Pruritus	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0184125	05/01/2002			53		F	01/02/2002	Report from a consumer who experienced swelling and bleeding at an influenza injection site eight months after starting Enbrel.									U	02/01/2001	10/01/2001	242	UNK	OTH	OTH	Enbrel	UNK	UNK		HQ8726726NOV2001	1						1	Injection site oedema	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0184127	05/01/2002	WY	75.0	75		M	03/11/2002	A nurse reported that a 75 year old male received an injection of flu shield on 11/28/2001. Immediately after receiving the injection, he developed a soreness of left arm. He was treated with prednisone. After completion of the prednisone therapy, he complained of overall muscle aches. Follow-up info received on 02/11/2002 indicated that he was diagnosed with polymyalgia rheumatica. A sedimentation rate was 57. FOLLOW-UP information received on 05/06/02 indicated that the physician believes that there is no relationship between polymyalgia rheumatica and the vaccine administration. The physician believes that the polymyalgia rheumatica has resulted from a progression of symptoms over many months.				Y					U	11/28/2001	11/28/2001	0	Erythrocyte sedimentation rate increased-57	PUB	OTH	Advil, Aspirin, Vioxx, glucophage	UNK	diabetes mellitus non insulin-dependent		HQ9852311JAN2002	1						1	Injection site hypersensitivity; Myalgia; Red blood cell sedimentation rate increased	FLU3~PFIZER\WYETH~4018053~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0184128	05/01/2002	NY	52.0	52		M	02/04/2002	A consumer reported that he received a dose of flu shield along with Pneu-Imune 23 vaccine on 12/26/2001. On 01/03/2002, he developed coughing, sneezing, and sniffles. No further info was available at the date of this report.									U	12/26/2001	01/03/2002	8	UNK	OTH	OTH	Axid, Dilantin, folic acid, Synthroid	UNk	Convulsions NOS, malignant neoplasm NOS, malignant tumor excision NOS		09889014	1						1	Cough; Sneezing; Nasal congestion; Pelvic pain; Pharyngitis; Rhinitis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~~~PNEUMO (PNU-IMUNE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0184129	05/01/2002	NJ				F	03/26/2002	A nurse reported that a female resident of a long-term care facility received a dose of flu shield in November 2001. In January 2002, the resident developed a severe respiratory infection characterized by congestion and fever. A diagnosis of influenza A was confirmed by rapid antigen testing. She recovered. No further info was available at the date of this report.									Y	11/01/2001	01/01/2002	61	UNK	OTH	OTH	UNK	UNK	UNK		HQ0016122JAN2002	1						1	Drug ineffective; Pyrexia; Respiratory tract infection; Upper respiratory tract infection	FLU3~PFIZER\WYETH~4018038~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0184130	05/01/2002	NJ				U	03/26/2002	A nurse reported that an employee at a long-term facility received a dose of flu shield in November 2001. Within 24-48 hrs, the employee developed a local reaction characterized by inflammation, warmth, and itchiness at the site of flu shield administration. The symptoms resolved approx 48 hrs after onset. No further info was available at the date of this report.									Y	11/01/2002	11/03/2002	2	UNK	OTH	OTH	UNK	UNK	UNK		HQ0030322JAN2002	1						1	Injection site hypersensitivity; Injection site inflammation; Injection site reaction; Injection site warmth; Pruritus	FLU3~PFIZER\WYETH~4018038~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0184131	05/01/2002	GA	51.0			F	02/04/2002	A 51 year old nurse reported that she received an injection of flu shield and subsequently developed a fever and felt sick. No further info was available at the date of this report.									U				UNK	OTH	PVT	NONE	UNK	UNK		HQ0185226JAN2002	1						1	Malaise; Pyrexia	FLU3~PFIZER\WYETH~4018032~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0184132	05/01/2002	GA				M	02/04/2002	A nurse reported that a male physician received an injection of Flu Shield (2001-2002 formula) and subsequently developed a fever and felt sick. No further information was available at the date of this report. This is 1 of 4 pts from this facility who had an adverse experience following receipt of Flu Shield (2001-2002 formula) lot 4018032. See MCN: HQ0185226JAN2002, HQ0408401FEB2002 and HQ0408501FEB2002.									U				UNK	OTH	PVT	UNK	UNK	UNK		HQ0408301FEB2002	1						1	Malaise; Pyrexia	FLU3~PFIZER\WYETH~4018032~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0184133	05/01/2002	GA				F	02/04/2002	A nurse reported that an adult female received an injection of Flu Shield (2001-2002 formula) and subsequently developed a fever, vomiting, diarrhea and felt sick. No further information was available at the date of this report. This is 1 of 4 pts from this facility who had an adverse experience following receipt of Flu Shield (2001-2002 formula) lot 4018032. See MCN: HQ0185226JAN2002, HQ0408301FEB2002 and HQ0408501FEB2002.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ0408401FEB2002	1						1	Diarrhoea; Nausea; Pyrexia; Vomiting	FLU3~PFIZER\WYETH~4018032~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0184134	05/01/2002	NY	71.0	70		M	03/15/2002	A consumer reported that her 71 year old father received Flu Shield (2001-2002 formula) (influenza virus vaccine, trivalent, types A & B/2001-2002 formula) vaccine on 1/10/02. The pt experienced muscle aches for 3 weeks, post vax. No additional information was available as of the date of this report.  The FOLLOW- UP letter sent to consumer with addresas from initial report was returned undelieverable.									U	01/10/2002	01/10/2002	0	UNK	OTH	PVT	Coumadin	UNK	UNK		HQ0513906FEB2002	1						1	Myalgia	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0184135	05/01/2002	MO	3.0			U	03/26/2002	A physician reported via a company representative, that a 3 year old child received Flu Shield (2001-2002 formula) (influenza virus vaccine, trivalent, types A & B/2001-2002 formula) vaccine. At a later date, the child tested positive for influenza by an office flu test. The flu immunization was given approx. 2 months prior to dx. The child developed a high fever that measured 103-104F, lethargy, cough and runny nose. This is 1 of 6 pts from this office who developed influenza following receipt of Flu Shield (2001-2002 formula) lot 4078033. See case ID numbers: HQ1480025MAR2002, HQ1480125MAR2002, HQ1480225MAR2002 and HQ1480325MAR2002. One pt was not identified; an additional report will be generated when identifying information is provided. No additional information was available as of the date of this report.				Y					U				Culture NOS-positive for influenza	OTH	OTH	UNK	UNK	UNK		HQ0713214FEB2002	1						1	Cough; Infection; Lethargy; Pyrexia; Rhinorrhoea	FLU3~PFIZER\WYETH~4078033~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0184136	05/01/2002	NJ				F	04/01/2002	A nurse reported that a female resident of a long-term care facility received a dose of Flu Shield (2001-2002 formula) in 11/01. In 1/02, the resident developed a severe respiratory infection characterized by congestion and fever. A dx of influenza A was confirmed by rapid antigen testing. She recovered. No further information was available at the date of this report. This is 1 of 8 residents of this facility who experienced adverse events following receipt of Flu Shield (2001-2002 formula) lot 4018038. The reporter also indicated that 7 employees of the facility experienced adverse events following receipt of Flu Shield (2001-2002 formula) lot 4018038.									Y	11/01/2001	01/01/2002	61	UNK	OTH	OTH	UNK	UNK	UNK		HQ0814221FEB2002	1						1	Infection; Nasal congestion; Pyrexia	FLU3~PFIZER\WYETH~4018038~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0184138	05/01/2002	NJ				U	03/26/2002	A nurse reported that a resident of a long-term care facility received a dose of Flu Shield (2001-2002 formula) in 11/01. In 1/02, the resident developed a severe respiratory infection characterized by congestion and fever. A dx of influenza A was confirmed by rapid antigen testing. The resident recovered. No further information was available at the date of this report. This is 1 of 8 residents from this facility who experienced adverse events following receipt of Flu Shield (2001-2002 formula) lot 4018038. The reporter also indicated that 7 employees of the facility experienced adverse events following receipt of Flu Shield (2001-2002 formula) lot 4018038.									Y	11/01/2001	01/01/2002	61	UNK	OTH	OTH	UNK	UNK	UNK		HQ1326814MAR2002	1						1	Infection; Nasal congestion; Pyrexia	FLU3~PFIZER\WYETH~4018038~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0184139	05/01/2002	NJ				F	04/01/2002	A nurse reported that a female resident of a long-term care facility received a dose of Flu Shield (2001-2002 formula) in 11/01. In 1/02, the resident developed a severe respiratory infection characterized by congestion and fever. A dx of influenza A was confirmed by rapid antigen testing. She recovered. No further information was available at the date of this report. This is 1 of 8 residents of this facility who experienced adverse events following receipt of Flu Shield (2001-2002 formula) lot 4018038. The reporter also indicated that 7 employees of the facility experienced adverse events following receipt of Flu Shield (2001-2002 formula) lot 4018028.									Y	11/01/2001	01/01/2002	61	UNK	OTH	OTH	UNK	UNK	UNK		HQ1331814MAR2002	1						1	Infection; Nasal congestion; Pyrexia	FLU3~PFIZER\WYETH~4018038~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0184140	05/01/2002	MO	4.0			U	03/26/2002	A physician reported via a company representative, that a 4 year old child received Flu Shield (2001-2002 formula) (influenza virus vaccine, trivalent, types A & B/2001-2002 formula) vaccine. At a later date, the child tested positive for influenza by an office flu test. The flu immunization was given approx. 2 months prior to dx. The child developed a high fever that measured 103-104F, lethargy, cough and runny nose. This is 1 of 6 pts from this office who developed influenza following receipt of Flu Shield (2001-2002 formula) lot 4078033. See case ID numbers: HQ0713214FEB2002, HQ1480125MAR2002, HQ1480225MAR2002 and HQ1480325MAR2002. One pt was not identified; an additional report will be generated when identifying information is provided. No additional information was available as of the date of this report.				Y					U				Culture NOS-positive for influenza	OTH	OTH	UNK	UNK	UNK		HQ1480025MAR2002	1						1	Cough; Infection; Lethargy; Pyrexia; Rhinorrhoea	FLU3~PFIZER\WYETH~4078033~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0184141	05/01/2002	MO	5.0			U	03/26/2002	A physician reported via a company representative, that a 5 year old child received Flu Shield (2001-2002 formula) (influenza virus vaccine, trivalent, types A & B/2001-2002 formula) vaccine. At a later date, the child tested positive for influenza by an office flu test. The flu immunization was given approx. 2 months prior to dx. The child developed a high fever that measured 103-104F, lethargy, cough and runny nose. This is 1 of 6 pts from this office who developed influenza following receipt of Flu Shield (2001-2002 formula) lot 4078033. See case ID numbers HQ0713214FEB2002, HQ1480025MAR2002, HQ1480225MAR2002 and HQ1480325MAR2002. One pt was not identified; an additional report will be generated when identifying information is provided. No additional information was available as of the date of this report.				Y					U				Culture NOS-positive for influenza	OTH	OTH	UNK	UNK	UNK		HQ1480125MAR2002	1						1	Cough; Infection; Lethargy; Pyrexia; Rhinorrhoea	FLU3~PFIZER\WYETH~4078033~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0184142	05/01/2002	MO	12.0			U	03/26/2002	A physician reported via a company representative, that a 12 year old child received Flu Shield (2001-2002 formula) (influenza virus vaccine, trivalent, types A & B/2001-2002 formula) vaccine. At a later date, the child tested positive for influenza by an office flu test. The flu immunization was given approx. 2 months prior to dx. The child developed a high fever that measured 103-104F, lethargy, cough and runny nose. This is 1 of 6 pts from this office who developed influenza following receipt of Flu Shield (2001-2002 formula) lot 4078033. See case ID numbers: HQ0713214FEB2002, HQ1480025MAR2002, HQ1480325MAR202 and HQ1480125MAR2002. One pt was not identified; an additional report will be generated when identifying information is provided. No additional information was available as of the date of this report.				Y					U				Culture NOS-positive for influenza	OTH	OTH	UNK	UNK	UNK		HQ1480225MAR2002	1						1	Cough; Infection; Lethargy; Pyrexia; Rhinorrhoea	FLU3~PFIZER\WYETH~4078033~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0184143	05/01/2002	MO	35.0			F	03/26/2002	A physician reported via a company representative, that a 35 year old pt received Flu Shield (2001-2002 formula) (influenza virus vaccine, trivalent, types A & B/2001-2002 formula) vaccine. At a later date, the pt tested positive for influenza by an office flu test. The flu immunization was given approx. 2 months prior to dx. The pt developed a high fever that measured 103-104F, lethargy, cough and runny nose. This is 1 of 6 pts from this office who developed influenza following receipt of Flu Shield (2001-2002 formula) lot 4078033. See case ID numbers: HQ0713214FEB2002, HQ1480125MAR2002, HQ1480225MAR2002 and HQ1480025MAR2002. One pt was not identified; an additional report will be generated when identifying information is provided. No additional information was available as of the date of this report.				Y					U				Culture NOS-positive for influenza	OTH	OTH	UNK	UNK	UNK		HQ1480325MAR2002	1						1	Cough; Infection; Lethargy; Pyrexia; Rhinorrhoea	FLU3~PFIZER\WYETH~4078033~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0184145	05/01/2002	OH				U	02/04/2002	An RN reported that an unidentified pt received Flu Shield (2001-2002 formula) (influenza virus vaccine, trivalent, types A & B/2001-2002 formula) and subsequently, developed an injection site reaction characterized by redness and swelling. This is 1 of 5 pts from this facility who experienced these events following receipt of (Flu Shield 2001-2002 formula) lot 4088052. One pt (not identified) developed an injection site reaction that measured 4 to 5 inches in diameter. No additional information was available as of the date of this report.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ9898614JAN2002	1						1	Injection site erythema; Injection site swelling	FLU3~PFIZER\WYETH~4088052~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0184197	05/03/2002	TX	30.0	30		M		Silver dollar sized red mark at injection site with mild pain and on left arm pit. Pain lasted for about 5 days, red mark went away in about 3-4 days. No treatment.									Y	04/12/2002	04/13/2002	1	NONE	MIL	MIL	NONE		Allergic to ampcillin			1						1	Injection site erythema; Injection site pain	FLU3~PFIZER\WYETH~U0674AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|JEV~SANOFI PASTEUR~EJN202A~2~SC~LA~JAPANESE ENCEPHALITIS (JE-VAX)~1|TD~SANOFI PASTEUR~U0386AA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0180359	05/06/2002		5.0	5		F		A report was received on 1/10/02 concerning a 6 year old female pt who experienced asthma crisis resulting in hospitalization 5 days after receiving the 2nd dose injection of Fluvirin, on 10/27/01; the 1st have been on 10/3/01. The pt had a medical history of cystic fibrosis. During the night of 11/1/01, the pt experienced an asthma crisis. The pt was hospitalized in the pediatric dept with fever of 37.8C and congestion. The pt recovered without sequela following IV antibiotic and corticosteroid treatment. The reporter has assessed the relationship of Fluvirin to the event as unclassifiable. A follow-up report was received on 4/24/02: The reporter assessed the causality of Flurvirin to the events as possibly related.					Y				Y	10/03/2001	11/01/2001	29		UNK	UNK			Cystic Fibrosis		PJP200200030	1						2	Asthma; Pyrexia; Asthma; Pyrexia; Upper respiratory tract infection	FLUX~UNKNOWN MANUFACTURER~769813~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~EVANS VACCINES~759813~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Hospitalisation	Influenza
0184240	05/07/2002	OR	34.0	36		F	05/01/2002	It was reported that a female pt received a dose of flu vaccine in December 2000 at a flu clinic where she resides. Lot number for vaccine is not available. Pt was diagnosed with Transverse myelitis shortly after she received vaccine. This information was reported by the pt's sister in behalf of the pt. When asked to provide more information, she stated that she would prefer her sister to call directly to provide additional information. The patient reported that she was 36 years old when this event occurred. Vaccine received was fluzone lot# U0345AC, date administerted 11/21/00. On 12/17/00 symptoms of back ache between shoulder blades, massive headache bagan. By the next day, pain radiated to right hand (numbness also present), difficulty breathing, legs became numb, she thought it was ashtma attack but her inhalers would not work. She was tranported to the hospital by ambulance. She was admitted on 12/19/00 and was in ICU on ventilator for two months. She was released to a rehabilitation facility approximately two months later, still on ventilator with tracheostomy. On 7/17/01 she was released from rehabilitation. Currently she still has limited use of her arms (right is worse than her left. She can walk with a quad cane and leg brace. She has a foley catheter, and her sensory perception is very limited from her shoulders down through her legs. From correspondence received at manufacturer on 5/13/02, it was determined that the code for difficulty breathing needed to be added to the COSTART listing.					Y			Y	N	12/01/2000				OTH	OTH					U200200296	1						1	Back pain; Dyspnoea; Headache; Myelitis transverse; Paraesthesia	FLU3~SANOFI PASTEUR~U0345AC~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0184887	05/08/2002	KS	26.0	27		F	05/08/2002	Face flushed/warm & injection site warm & blotchy within 5 minutes of injection.  Gave Benadryl 25 mg at 1350 po & 40 minutes of ice to site.				Y					Y	10/16/2001	10/16/2001	0		PVT	PVT		None	PCN, Morphine			1						1	Flushing	FLU3~SANOFI PASTEUR~U0672AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0184400	05/10/2002	CA	68.0	68		F	05/09/2002	The pt developed vomiting and headache about 9 hrs after receiving the flu vaccine. By 11/05/2001, onset of severe vertigo for four days followed by intermittent vertigo for three months. Treated with unspecified medication and fully recovered.				Y					Y	11/04/2001	11/04/2001	0		OTH	OTH	Aciphex, Toprol	NONE	High blood pressure, hypercholesterolemia	Flu-like symptoms~Influenza (Seasonal) (no brand name)~0~60.00~In Patient		1						1	Headache; Vertigo; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0184429	05/13/2002	IL	68.0	67		F	05/06/2002	Same day as flu shot was administered, the pt present at ER with erythema of face, neck, upper chest, shakiness and fever. Per doc 213904, eyes watering, temp of 103, muscle pain. The discharge summary states febrile illness, reaction to vaccination.				Y	Y	1			Y	10/31/2001	10/31/2001	0	WBC-6.8 (neutrophils-76.1%, lymphocytes 17.8%); Blood and Urine cultures-no growth	OTH	OTH	Metamucil, Multi-vitamin, Vitamin C	NONE	Allergy to Cipro, Compazine, Darvon, Ceclor			1						1	Body temperature increased; Erythema; Lacrimation increased; Myalgia; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U060ZBA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0184430	05/13/2002	ND	26.0	24		F	05/09/2002	This report states that in February 2001, the pt fell while skiing. Approximately 3 days later she began experiencing numbness of the entire left side. She received an initial evaluation from local physicians who attributed the symptoms to her fall. She was diagnosed with muscle strain, put on a 2 week profile and prescribed Tylenol. The symptoms only slightly resolved with some residual numbness in the fingers of her left hand. on 06/03/2001 she presented to the medical clinic with complaints of a headache times three weeks with increasing pain in her right eye with decreased and darkened filed of vision. Within a few days she had total loss of vision in her right eye. She was evaluated locally and referred to optometry. That same day, optometry reported a +2-3 afferent papillary defect OD and severe color vision loss OD; fundus esam of healthy retinas OU with cup-to-disk ration approximately 0.4 with physiological cupping and lamina OU. She was treated with Solumedrol 1 gran /IV for five days then put on a Prednisone taper of 60 mg x 5d, 40mg x 3 days, 20 mg x 2 d. Her eyesight slowly returned-initially seeing shadows, then light and eventually full vision. She had not had a recurrence of these symptoms. During the evaluation of the optic neuritis, an MRI of the brain showed findings consistent with a demyelinating disease such as MS or Lyme disease. Further evaluation and lab tests ruled out Lyme disease. A second MRI of the brain two weeks later showed an area of hyper intensity in the spinal cord at C4-5 consistent with demyelinating plaques as in MS. One neurologist remarked that the left-sided numbness the pt experienced in February could not be attributed to a fall that happened five days prior and considered that set of symptoms the first sign of the demyelinating disease. Furthermore, combination of symptoms was definitely multiple sclerosis. During the time of this evaluation, the pt was pregnant; therefore other neurologist were hesitant to make a definite diagnosis of MS. In December 2001, she had a normal vaginal delivery without complications. A MRI done following her delivery showed the plaques were unchanged. Treatment with medication was delayed due to breastfeeding but she is currently on Avonex injections once a week for her symptoms. She has expereinced flu-like symptoms for 24-48 hrs following both of the two Avonex injections she has received. These are fairly common effects of the medication. The pt has a history of migraine headaches; however, these headaches have become more severe. Currently she experiences these pains once or twice a week at the same level of intensity. She noticed increasing fatigue and still experienced daytime somnolence. On July 5, 1999 approximately 5-6 weeks after anthrax vaccine #4, she developed pruritic papules over her entire body and began to experience swelling over her entire body.  She also has short term memory problems.				Y					N	12/07/2000	02/06/2001	61	MRI-lesion within the right frontal white matter, approximately 2.5cm in the greatest ovoid dimension. 5-6 other smaller 1-4mm focal areas of abnormal increasing intensity within the white matter. Demyelinating plaques that would be seen in multiple sclerosis.	MIL	MIL	Orthotricyclin, Imitrex prn, Avonex, Ambien, Wellburin, Naprosyn prn, Flexeril prn	NONE	Migraine headaches, TMJ (temporomandibular joint), oophorectomy			1						1	Blindness; Eye pain; Fall; Fatigue; Headache; Hypoaesthesia; Influenza like illness; Memory impairment; Multiple sclerosis; Optic neuritis; Rash pruritic; Somnolence; Swelling; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~4008209~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0184497	05/14/2002	WA	62.0	62		F	01/31/2002	A few hives-neck down to bottom of buttocks-itch occasionally. They are fading away as of 1/31/02. Joints hurt very bad. Taking an antahistamines.									Y	01/24/2002	01/25/2002	1	NONE	PUB	PUB		NONE	Heart problem, diabetes, hypertension		WA021823	1						1	Arthralgia; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4018026~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0184498	05/14/2002	WA	81.0	81		F	01/15/2002	The day after the vaccination, the pt walked into the living room and fell to the floor. She states that she blacked out. NO dizziness, headache, confusion before or after the incident. She felt fine afterwards did not go to the doctor's till two days later. Doctor started her on baby asprin 1 daily.				Y					Y	11/26/2001	11/27/2001	1		OTH	PUB	Darvocet	NONE	Osteoporosis, arthritis, mold allergy		WA021818	1						1	Fall; Loss of consciousness	FLU3~PFIZER\WYETH~4018026~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0184577	05/15/2002	NY	46.0	46		F	05/09/2002	Severe shooting pain in upper extremity, muscle pain/spasms. EMG's demonstrated bilateral plexopathies. Questionable Guillain-Barre.				Y					Y	01/24/2002	01/28/2002	4	EMG-demonstrated bilateral plexopathies; SSEP; MRI brain; MRI C-spine (open); MRI C-spine (closed) and blood work.	PVT	PVT	Synthroid	Polyneuropathy (Guillain-Barre)	Hypothyroidism			1						1	Guillain-Barre syndrome; Muscle spasms; Myalgia; Pain; Polyneuropathy	FLU3~PFIZER\WYETH~4018030~4~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0184636	05/15/2002	NJ		66		F	11/20/2000	Information has been received from a 66 year old female pt. The pt's concurrent illness included osteoarthritis NOS, previously treated with Synvisc approximately ever 6 months. Past history included a knee arthroplasty 10-12 years ago. Therapy with Synvisc for osteoarthritis NOS included one 2mL injection every week for three weeks in the left knee in Jul-2000. Additional suspect medication included Flu Shield and Pnu Imune 23 vaccine. Therapy with Flu shield included one dose injection in the right arm on 10/14/2000. Therapy with Pnu Imune 23 vaccine included one dose injection in the left arm on 10/14/2000. The pt reported swellin gin bck of the knee (joint swelling) on 10/17/2000 and asked if there had been a Synvisc interaction with the flu or pneumonia vaccine. The left knee swelling is resolving. Additional information has been requested.									U	10/14/2000	10/17/2000	3	UNK	OTH	OTH	Synvisc	UNK	Osteoarthritis NOS; joint injection; knee arthroplasty		HQ2614623OCT2000	1						1	Joint swelling	FLU3~PFIZER\WYETH~~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0184637	05/15/2002	NY	60.0			U	02/12/2002	A nurse reported that a 60 year old female received an injection of Flu Shield on 11/26/2001 from a lot that had expired 06/2001. This report was received 1 day post-immunization; No adverse experience had occurred at the time. Follow-up information received from the physicians on 02/05/2002 indicated that 2-3 wks post-vaccination, the pt developed upper respiratory symptoms. The pt recovered w/out treatment.									U	11/26/2001			NONE	UNK	UNK					HQ8888628NOV2001	1						1	Upper respiratory tract infection	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0184648	05/16/2002	AZ	48.0	47		M	05/06/2002	The pt developed fever of 102-103 deg. F, myalgia, and headache. Within a few weeks, hand and joint pain started. The pt was diagnosed with rheumatoid arthritis on 04/02.								Y	N	12/01/2001	01/01/2002	31	Rheumatoid factor-positive	PVT	PVT	Prozac, Proton pump inhibitors		Dysthymia, GERD, Headaches, Low back pain, Irritable bowel			1						1	Arthralgia; Headache; Myalgia; Pyrexia; Rheumatoid arthritis; Rheumatoid factor	FLU3~SANOFI PASTEUR~U0601AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0184657	05/16/2002	KS	68.0	68		M	10/17/1997	The pt developed swollen, red area below deltoid muscle above elbow. He also felt feverish and was slightly nauseated immediately after the injection. He also had a flew shot the same day.									Y	10/15/1997	10/16/1997	1	NONE	PUB	PUB						1						1	Body temperature increased; Injection site erythema; Injection site oedema; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0994E~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0185040	05/22/2002	IL	32.0	32		M	05/16/2002	On 11/14, the pt experienced body soreness. He could not pick up anything unless both hands were used. The symptoms gradually resolved over 1-1 1/2 weeks. He did not seek medical attention. Advised to consult MD before receiving further flu vaccinations.									Y	11/09/2001	11/14/2001	5	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Arthralgia; Asthenia; Myalgia	FLU3~EVANS VACCINES~E04821KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0185325	05/24/2002	NY	41.0	40		F	01/03/2002	The pt developed swelling in throat, tingling in tongue, flushed feeling chest and back. Pt had elevated pulse and BP. Hyperemia noted. A follow up report received on 5/30/2002 adds: Hyperemia noted on chest. Rx: IV and PO Benadryl, observed for 4 hours. Home without recurrence of problems.				Y					Y	01/01/2002	01/01/2002	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Blood pressure increased; Flushing; Heart rate increased; Hyperaemia; Paraesthesia; Pharyngeal oedema	FLU3~EVANS VACCINES~E11941LA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0179993	05/28/2002	OK	57.0	57		F	01/10/2002	The pt began having soreness in left upper arm approximately 2 hrs after receiving Pneumovax. By 6pm, pain got worse, noted swelling and felt hot to touch. Now experiencing itching that started at noon today.									Y	01/09/2002	01/09/2002	0	CBC-slight elevation	PUB	OTH	Timopic, Lantanoprost	NONE	Glaucoma		OK0209	1						2	Injection site pain; Injection site swelling; Injection site warmth; Pruritus; White blood cell count increased; Injection site hypersensitivity; Injection site oedema; Injection site pain; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U0699AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1076K~2~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U0699AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1076K~2~IM~LA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0185430	05/28/2002	OK	39.0	39		M	12/17/2001	The pt developed a local reaction. The pt had an inflamed area at site for at least one month. Doctor treated with antibiotic and that resolved. Also, the pt had joint pain in shoulder when moving arm. Not resolved yet; doctor is treating with Vioxx.				Y					Y	10/17/2001	10/18/2001	1	NONE	PVT	OTH	Indural LA 80	NONE	Mitral valve prolapse		OK0159	1						1	Arthralgia; Injection site inflammation; Injection site reaction	FLU3~SANOFI PASTEUR~U0685AA~7+~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0185431	05/28/2002	OK	55.0	55		F	12/19/2001	Trivalent influenza 0.5cc IM at approximately. Client phoned health department that after injection complained of tongue swelling. Client to ER. Treated at ER. Treated and released home.				Y					Y	12/12/2001	12/12/2001	0	NONE	PUB	OTH	UNK	NONE	Doctor long time ago told patient she was allergic to eggs. Patient eats eggs.		OK0208	1						1	Tongue oedema	FLU3~EVANS VACCINES~4018024~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0185432	05/28/2002	OK	48.0	48		F	03/07/2002	On 02/05/2002, client called complaining of pain in chest and on left arm. Referred to PMD immediately. PMD told client that the flu shot may have overtaxed her immune system.				Y					Y	02/04/2002	02/05/2002	1		PUB	PUB			Lupus; chronic bronchitis		OK0215	1						1	Chest pain; Injection site pain	FLU3~PFIZER\WYETH~4018057~2~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0185433	05/28/2002	OK	36.0	36		F	02/04/2002	Pt complained of severe headaches, numbness of arm and hands, 24 hrs later, still numbness and tingling in left hand. Pt was very flushed and feverish. Still complaining of sick feeling.									Y	01/22/2002	01/22/2002	0	NONE	PUB	PUB	NONE	NONE	NONE		OK0211	1						1	Flushing; Headache; Hypoaesthesia; Paraesthesia; Pyrexia	FLU3~PFIZER\WYETH~5018024~1~~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0185592	05/28/2002	PA	82.0	82		F	05/28/2002	11 a.m. flu vaccination 7:00 pm 3/4 wide & 4 long macule on medial aspect of arm, pruritic & warm to the touch									Y	10/29/2001	10/29/2001	0	no	PUB	PUB	Synthroid	no	environmental and PCN allergies		PA0201	1						1	Feeling hot; Pruritus; Rash macular	FLU3~EVANS VACCINES~E065751LA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0185520	05/29/2002	VA	63.0	63		M	05/24/2002	An adult male alleges that he received an injection of FluShield vaccine on or about 01/04/2000 and developed severe personal injuries, including paralysis from Guillain-Barr syndrome, 2 to 3 weeks post-vaccination. He also alleges that he suffered great physical pain and mental anguish due to such injuries and claims that he has been left with permanent residual deficits. No further info was available at the date of this report. This report of a serious, labeled event is being submitted in a 15-day time frame as requested by FDA. A 15-day follow up report received 04/23/2003 adds: Follow-up medical records received on 04/10/2003 via the pt's attorney provided medical history, concomitant medications, an event onset date, pt age at event, pt date of birth, dates of hospitalization, laboratory test results, and event course. A legal complaint was received from an attorney regarding a 63 year-old white male pt who received an injectin of FluShield vaccine on 01/04/2000. Concomitant therapy included Cozaar (Losartan potassium) and bumetanide for hypertension; Glucotrol (glipizide) for non-insulin-dependent diabetes, and Lipitor (atorvastatin) for hypercholesterolemia. The pt's medical history also includes smoking, renal insufficiency, and asthma. On 01/24/2000, the pt developed paresthesias in his legs with progressive weakness as well as tingling in this hands and facial area around his lips. On 01/26/2000, he was hospitalized in the intensive care unit to rule out Guillain-Barre syndrom/acute inflammatory demyelinating polyneuropathy, rule out cervical myelopathy. A CAT scan of the brain performed that day revealed mild cerebral atrophy with no evidence of tumor, intracranial hemorrhage, or infarct. On 01/27/2000, the pt was transferred to the intensive care unit of a second hospital facility for plasmaphoresis. An MRI of the brain performed that day was unremarkable; however, Guillain-Barre syndrom was not excluded. While hospitalized, the pt received 6 courses of plasmaphoresis and made 'slow but gradual' improvement of his numbness and weakness, with greater strength in his upper extremities than in his lower extremities. He reportedly 'responded well' to physical therapy. On 02/10/2000, he was discharged with a final diagnosis of Guillain-Barre syndrome to a rehabiitation facility for physical therapy. He was subsequently discharge home with a walker. Motor nerve conduction studies of the bilateral upper extremities and bilateral lower extremities performed on 06/12/2000 were 'markedly abnormal' and demonstrated polyneuropathy with axonal and demyelinating features. EMG of the right upper extremity was limited due to the pt's intoleerance to the examination but revealed normal right biceps and right pronator teres muscles. A physician's note dated 10/11/2000 indicated that the pt has permanent impairment of strength. This report of a serious, labeled event is being submitted in a 15-day time frame as requested by FDA. Follow up on 08/15/2003: Additional information was received from the plaintiff's attorney on 08/04/2003.  A medical consultant reviewed the patient's hospital admissions and medical records sent to him by counsel covering the time period of 01/27/2000-12/06/2000 and provided additional laboratory results.  He noted an MRI of the patient's spine on 01/27/2000 showed degenerative changes and small herniation at T8-T9.  A legal complaint was received from an attorney regarding a 63 year old white male patient who received an injection of FluShield vaccine on 01/04/2000.  Concomitant therapy included Cozaar and bumetanide for hypertension; Glucotrol for non-insulin-dependent diabetes; and Lipitor for hypercholesterolemia.  The patient's medical history also includes smoking, renal insufficiency, and asthma.  On 01/24/2000, the patient developed paresthesias in his legs with progressive weakness as well as tingling in his hands and facial area around his lips.  On 01/26/2000, he was hospitalized in the intensive care unit to rule out Guillian-Barre syndrome/acute inflammatory demyelinating polyneuropathy, rule out cervical myelopathy.  A CAT scan of the brain performed that day revealed mild cerebral atrophy with no evidence of tumor, intracranial hemorrhage, or infarct.  On 01/27/2000, the patient was transferred to the intensive care unit of a second hospital facility for plasmaphoresis.  An MRI of the brain performed that day was unremarkable; however, Guillian-Barre syndrome was not excluded.  While hospitalized, the patient received 6 courses of plasmaphoresis and made slow but gradual improvement of his numbness and weakness, with greater strength in his upper extremities than in his lower extremities.  He reportedly responded well to physical therapy.  On 02/10/2000, he was discharnged with a final diagnosis of Guillian-Barre syndrome to a rehabilitation facility for physical therapy.  He was subsequently discharged home with a walker.  Motor nerve conduction studies of the bilateral upper extremities and bilateral lower extremities performed on 06/12/2000 were markedly abnormal and demonstrated polyneuropathy with axonal and demyelinating features.  EMG of the right upper extremity was limited due to the patient's intolerance to the examination but revealed normal right biceps and right pronator teres muscles.  A physician's note dated 10/11/2000 indicated that the patient has permanent impairment of strength.  This report of a serious, labeled event is being submitted in a 15-day time frame as requested by FDA.  A 15-day follow up report received 08/14/2003 adds: Additional info was received from the plaintiff's attorney on 08/04/2003. A medical consultant reviewed the pt's hospital admissions and medical records sent to him by counsel covering the time period of 01/27/2000 through 12/06/2000 and provided additional laboratory results. He noted an MRI of the pt's spine on 01/27/2000 showed degenerative changes and small herniation at T8-T9. A legal complaint was received from an attorney regarding a 63-year-old male pt who received an injection of FluShield vaccine on 01/04/2000. Concomitant therapy included Cozaar (losartan potassium) and bumetanide for hypertention; Glucotrol (glipizide) for non-insulin-dependent diabetes; and Lipitor (atorvastatin) for hypercholesterolemia. The pt's medical history also includes smoking, renal insufficiency and asthma. On 01/24/2000, the pt developed paresthesias in his legs with progressive weakness as well as tingling in his hands and facial area around his lips. On 01/26/2000 he was hospitalized in the intensive care unit to rule out Guillain-Barre syndrome/acute inflammatory demyelinating polyneuropathy, rule out cervical myelopathy. A CAT scan of the brain performed that day revealed mild cerebral atrophy with no evidence of tumor, intracranial hemorrhage, or infarct. On 01/27/2000 the pt was transferred to the intensive care unit of a second hospital facility for plasmaphoresis. An MRI of the brain performed that day was unremarkable; however, Guillain-Barre syndrome was not excluded. While hospitalized, the pt received 6 courses of plasmaphoresis and made slow but gradual improvement of his numbness and weakness, with greater strength in his upper extremities than in his lower extremities. He reportedly responded well to physical therapy. On 02/10/2000 he was discharged with a final diagnosis of Guillain-Barre syndrome to a rehabilitation facility for physical therapy. He was subsequently discharged home with a walker. Motor nerve conduction studies of the bilateral upper extremities and bilateral lower extremities performed on 06/12/2000 were markedly abnormal and demonstrated polyneuropathy with axonal and demyelinating features. EMG of the right upper extremity was limited due the the pt's intolerance to the examination but revealed normal right biceps and right pronator teres muscles. A physician's note dated 10/11/2000 indicated that the pt has permanent impairment of strength. This report of a serious, labeled event is being submitted in a 15-day time frame as requested by FDA.  Medical records state weakness, hypotension. msv					Y			Y	N	01/04/2000	01/24/2000	20	Electromyogram (EMG) 06/12/2000 Limited due to pt's intolerance of examination; right biceps and right pronator terres muscles were normal.  Nerve conduction studies abnormal (LLT: motor nerve conduction studies abnormal) 06/12/2000 Bilateral upper and lower extremities: polyneuropathy with axonal and demyelinating features. Nuclear magnetic resonance imaging brain (LLT:MRI brain) 01/27/2000 Unremarkable; results do not exclude Guillain-Barre disease.  Scan NOS brain (LLT:CT brain scan) 01/26/2000 Mild cerebral atrophy with no evidence of tumor, intracranial hemorrhage, or infarct. Medical records state abnormal lab tests. msv	OTH	OTH	Bumetanide, Cozaar, Glucotrol, Lipitor.	UNK	Diabetes, hypertension, asthma Medical records state cerebral atrophy, cervical spondilosis, hypercholesteremia, arthritis, renal insufficiency, reactive airway disease. msv		HQ2424423MAY2002	1						1	Anger; Asthenia; Cerebrovascular disorder; Guillain-Barre syndrome; Hypotension; Laboratory test abnormal; Pain; Paraesthesia; Paralysis	FLU3~PFIZER\WYETH~4998253~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0185824	05/31/2002					U		A report was received from a health professional on 10/11/2001, concerning a pt of unknown demography who developed multiple sclerosis and neurological symptoms which were disabling/incapacitating, shortly after receiving the Fluvirin vaccine on 10/21/1996. On 10/21/1996, the pt developed multiple sclerosis and neurological symptoms, shortly after receiving the Fluvirin vaccine. The pt has not received any flu vaccinations since 1996. The pt had not recovered at time of report. The reporter has assessed the relationship of study medication to the events as unknown.								Y	U	10/21/1996	10/21/1996	0		UNK	UNK	UNK				PJP200100314	1						1	Multiple sclerosis; Neurological symptom	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0185832	05/31/2002	VI	38.0			F		Pt received flu vaccine 10/22/01 and experienced a flu like syndrome for a short while he has had recurrent herpes simplex lesion on her buttocks. episodes went from being very infrequent to 1-2 events every month. Clearly related to menstrual cycle Lesions respond to Denavir (topical).										10/22/2001	10/22/2001	0	NONE	UNK	UNK	NONE		Episodes of retained placenta in 2000			1						1	Herpes simplex; Influenza; Skin ulcer	FLU3~EVANS VACCINES~E00941HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0185833	05/31/2002		46.0	46		M	01/10/2002	Was given the flu shot on his first day of feeling better after being ill for several weeks with a virus. By evening of the same day, he had to go to bed due to feeling ill with fever, aches and malaise for the next 48 hrs.									Y	12/17/2001	12/17/2001	0		UNK	UNK						1						1	Malaise; Pain; Pyrexia	FLU3~SANOFI PASTEUR~UO713AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0186189	06/10/2002	KY				F	06/06/2002	An attorney alleges that a female received Tetanus and Diphtheria Toxoids Absorbed, Purogenated and influenza virus vaccines on 13 DEC 2000. Immediately following immunization, the patient experienced excruciating (beyond description) pain, severe burning and a throbbing/pulsating sensation, that was so bad, she was unable to sleep the entire night. The pain in her arm radiated into her neck and shoulder. She notified her physician who indicated that it was normal and would subside. The patient continued experiencing right arm and hand pain with 2 fingers on her right hand drawing. As time moved forward, she experienced weakness and twitching in both her arms. Between May and June 2002, the patient's condition began to deteriorate; she was unable to use either arm for anything. She also experienced difficulty breathing. In August 2001, she was hospitalized for respiratory failure and placed into intensive care unit. She was released in September 2001 and had lost the use of both her arms. Her neck muscles had deteriorated to the point that she need assistance to maintain head elevation. Her weakness and deterioration affected her lungs and throat. The patient could barely breathe and had difficulty swallowing. According to the attorney, her problems were so severe, she was intubated and a feeding tube was inserted. As of the date of this report, the patient required 24 hour care due to her injuries. As of the date of this report, no further information was available.				Y	Y			Y	U	12/13/2000			UNK	OTH	OTH	UNK	UNK	UNK		HQ2610505JUN2002	1						1	Dysphagia; Insomnia; Muscle twitching; Muscular weakness; Neck pain; Paralysis; Respiratory failure	DT~LEDERLE LABORATORIES~466025~UNK~~RA~DT ADSORBED (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~V0488AA~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0186198	06/10/2002	MA	72.0	72		F		Four days after receiving flu shot, Ms Katz noticed that she was having difficulty raising her left arm. She reported this to me on 11/21/01. She had no visible signs of redness or swelling and ROM was WNL. Seen by dr on 11/27/01. No signs of infection. No treatment. On 01/29/01, arm was much better.									Y	11/06/2001	11/20/2001	14	NONE	PUB	PUB	Lithium, Synthroid, Tums, vitamins	NONE	Hypothyroid		MA0203	1						1	Joint range of motion decreased	FLU3~SANOFI PASTEUR~UO676AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0186199	06/10/2002	MA	42.0	42		M	01/23/2002	On 04/05/01, states that arm bothered him right away. C/O weakness in arm, discomfort when he puts on or lifts. Cant's lift hands over his head without pain. Talked to MD's nurse who told him to take Tylenol. On 05/22/02, better now but still feels discomfort occasionally.									Y	10/22/2001	10/22/2001	0	NONE	OTH	PVT		NONE	Environmental allergies (dogwood, grass, pollen, etc)			1						1	Discomfort; Hypokinesia; Muscular weakness; Pain	FLU3~SANOFI PASTEUR~V0669AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0186283	06/11/2002	FL	55.0	55		M	05/06/2002	Pt complained of redness and swelling hard knot with pain right deltoid 05/04 yellow fever vaccine deltoid 4.0 x 6.0cm firm. Treated with ice packs, Tylenol. RTC RRN				Y					Y	05/04/2002	05/05/2002	1		MIL	MIL	PPD (C0866AB)	NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site mass; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U0675AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|YF~SANOFI PASTEUR~UB142AA~2~~RA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0186532	06/17/2002	TX	1.5	0	.0	M	07/20/2004	This report describes mercury poisoning in a male, now 4 year old, who received Hepatitis B  vaccine. It was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not provided. The child received injections of hepatitis B vaccine on 2/28/98, 5/1/98, and 9/3/98. He also received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed 5/1/98, 7/8/98, 9/3/98, and 6/22/99; Haemophilus influenzae type B conjugate vaccine 5/1/98, 7/2/98, 9/3/98, and 6/22/99; oral poliomyelitis virus vaccine 5/1/98, 7/2/98, and 6/22/99; MMR 3/16/99, and varicella virus vaccine 3/16/99. The vaccine's attorney alleged that the vaccines experienced mercury poisoning due to vaccines administrated from 02/1998 through at least through at least 06/1999. Time to onset from immunization and treatment were not provided. This report of mercury poising is considered by the manufacturer as medically serious. The following information was obtained from medical records. A mother gave birth to a nine pound male infant who was 21.5 inches in length on 28 February 1998. The mother had a history of asthma since birth. The summer of 1997, she was diagnosed with a fat pad on her heart. She claimed that she had no symptoms as a result of the fat pad. The mother was given epidural analgesia with 1% lidocaine during labor and delivery. She delivered a normal infant via vaginal delivery. The mother received oxytocin post-delivery. She was found to be positive for Streptococcus B and was given ampicillin. The infant Apgar scores at one and five minutes were 9/9. The first hepatitis B vaccine was received on 28 February 1998 and was hepatitis B vaccine recombinant (Engerix-B) given intramuscularly.  The child's developement began normally. He sat unassisted at five months of age, crawled at six months of age, walked alone at nine months of age. He spoke his first word at nine months of age and at 12-14 months of age he reported that her son stopped looking at her. At 14 months of age, he began to lose these words. His hearing was tested and found to be normal. When the patient was 18 months of age, the symptoms of autism began. He had poor eye contact, poor speech, and unfocused activity. When the child was approximately 4 years of age, his physician wrote, Due to persistent neurological aberrations as well as autistic tendencies..., I recommend he forego immunizations for MMR and DPT for the near future. The child was treated with risperidone (Risperdal) and dextroamphetamine sulfate (Dextrostat) and prescribed occupational therapy and speech therapy. On 19February03, occupational therapy was terminated due the child's aggressive behaviour. He was referred to a behavioral specialist. The most recent information received on 6/21/04, indicated that as of 05May04 the child was still undergoing speech therapy. This report of autism and mercury poisoning are considered medically serious (OMIC). Following the reported onset of autism, the pt experienced fungal infection and frequent respiratory infections. He developed an allergy to mold and yeast (onset date of allergies not reported). These were not reported as adverse events due to vaccine administration, but were found during the course of review of the pt's medical records. Therefore, they are not listed as adverse events.   Follow up on 07/12/04 states: No new information.				Y					N	02/28/1998			Urine metal screen performed 24April2004 had elevated levels of tin manifested by a value of 16mcg/g (normal value less than 6).Urine collected 29Jul03 was within normal limits for toxic metals. Tin level had decreased to 3.6 (normal less than 6).	OTH	OTH	Tuberculin PPD	UNK	Medical history and concurrent conditions and were not provided. The child developed normally through the first year of life.		A0370533A	1						1	Autism; Drug toxicity; Fungal infection; Hypersensitivity; Respiratory tract infection	FLUX~UNKNOWN MANUFACTURER~~3~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~~1~IM~~HEP B (ENGERIX-B)~1|HIBV~UNKNOWN MANUFACTURER~~3~~~HIB (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0177030	06/21/2002	TX	39.0	39		F	07/11/2001	A 39 year old female with no previous medical conditions, received the 3rd dose of Anthrax vaccine (lot #FAV038) on 03 December 1999. Relevant diagnostic tests performed are unknown because the patient was seen by a private physician at an air force base. Concomitant medications at the time of the event, any illness at the time of vaccination, and previous reactions to vaccines are unknown. On 17 December 1999, the patient began experiencing problems with her right elbow that were manifested by her dropping her weapon. The outcome of this event is unknown at this time.									U	12/03/1999	12/17/1999	14	Unk	MIL	MIL	Unk	Unk	None		BIT010026	1						2	Muscular weakness	ANTH~EMERGENT BIOSOLUTIONS~FAV038~3~SC~~ANTHRAX (BIOTHRAX)~2|FLU3~SANOFI PASTEUR~OU166AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0186816	06/21/2002		58.0			M		An anonymised single pt print was received on 06/17/2002 concerning a 58 year old male pt, who experienced myocardial infarction 4 hrs after receiving FluVirin on 11/20/2001. At the time of reporting, the pt had recovered. There was insufficient info to determine the reporter's causality assessment.					Y				Y	11/20/2001	11/20/2001	0		UNK	UNK					PJP200200354	1						1	Myocardial infarction	FLUX~UNKNOWN MANUFACTURER~760041~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0186817	06/21/2002	HI	19.0	19		M	08/16/2001	Subject BIT010006, a 19 year old male with no known previous medical conditions, received the 2nd dose of Anthrax vaccine (Lot FAV044) on 01/11/2000. Other vaccines given on this date included, yellow fever, typhoid, influenza, and hep A. The pt was taking no concomitant medications at the time of the event. No previous reactions to the Anthrax vaccine are known. In March 2000, the pt experienced the first of seven episodes which lasted less than one minute and occurred over an eleven month period. The first episode began with heat exhaustion during a road march in late February or early March 2000. The second episode occurred in April 2000 during a 12-mile road march. The last syncopal episode occurred in June 2001. The pt had evaluations by cardiology, pulmonary, endocrine, and psychology specialists and no etiology has been identified. Treatment for this event and the outcome are unknown at this time.				Y					U	01/11/2000	03/01/2000	50	Holter monitor, echocardiogram, spirometry, pulmonary function test, electrocardiogram, electroencephalogram were all unremarkable. CBC, electrolytes, tox screen, UA, LFT, TFT were normal.	MIL	MIL	NONE	NONE	NONE		BIT010006	1						1	Syncope	ANTH~EMERGENT BIOSOLUTIONS~FAV044~2~SC~LA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~1~~~HEP A (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~1~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|YF~CONNAUGHT LABORATORIES~7347AD~1~~~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0186861	06/24/2002	CA				U		Flu shot first week in October 10/98, by 10/12/98 huge infected mass forms on chest rather got flu symptoms immediately after shot. WBC doubled over night and WBC kept rising, RBC falling until dead 5 months later. March 10, 1999 cortizons injected to knee March 14, 1999 dead.	Y	03/14/1999							N					PVT	UNK		NONE	Decades of undefined anemia (in family)			1						1	Infection; Influenza like illness; Red blood cell count decreased; White blood cell disorder	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0186864	06/24/2002	TX	40.0	40		U	06/13/2002	The pt experienced shortness of breath and hives formed all over her body.					Y					01/25/2002	01/25/2002	0		UNK	UNK						1						1	Dyspnoea; Urticaria; Dyspnoea; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4018646~3~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0186864	06/26/2002	TX	40.0	40		F	06/25/2002	The pt experienced shortness of breath and hives formed all over her body. The pt was not hospitalized. She was seen in an out-patient clinic. Treatment: Kenalog 40mg IM, Atarax 25mg q 8h.									Y	01/22/2002	01/25/2002	3		PUB	PUB	Albuterol; Flonase; Nexium; Allegra		Asthma, chronic rhinitis, hypertension, iodine allergy			1						2	Dyspnoea; Urticaria; Dyspnoea; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~4018646~3~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0187108	07/02/2002	AZ	50.0	50		F	06/25/2002	Developed laryangtitis, wentinto severe bronchitis, right and left legs gone weak especially right leg. ER treatment and sent home. My own doctor dx Guillane Barre syndrome, IV human immunoglobulins treatment. The 60 day folow-up states that after going through five session of IV immunoglobulins am still experiencing painin my legs and am still under a neurologist care. The annual follow up received on 7/23/03 states, depression, anxiety, body jerks and I am still seeing a neurologist, 200mg daily of Zoloft and mild ?			Y	Y					N	12/05/2001	12/08/2001	3	Cat Scan for brain and lungs, MRI, EMT, Back xrays; 5 doses IV Human Immoglobulin.	PUB	PVT	Paxil					1						1	Anxiety; Bronchitis; Depression; Dyskinesia; Guillain-Barre syndrome; Laryngitis; Muscular weakness; Bronchitis; Contusion; Difficulty in walking; Guillain-Barre syndrome; Laryngitis; Muscle twitching; Pain	FLU3~SANOFI PASTEUR~U0696AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U0696AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0994L~UNK~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Life Threatening	Influenza
0187767	07/19/2002	WV	38.0	38		M	07/17/2002	The patient is a 38 year old male who recently had a flu shot on 2/1/01, two days later on 2/3/01 he developed weakness of both lower legs from hips to legs. He reported to the ER on 2/4/01 where he was assessed as having back pain from muscle strain and was sent home on Naproxin. He returned on 2/6/01 with progression of weakness of both lower extremities and stiffness of both shoulders, digressed vocal tone, slurred speech and worsening of generalized proximal muscle weakness. ER physician discussed with neurologist at hospital and MD suspected of Guillain Barre Syndrome, was advised to start the patient on immunoglobulin at 400 mg per kg per day. On 2/6, the patient received only 12 grams of immunoglobulin. On 2/7, he had 28 grams of immunoglobulin. When I saw him on 2/7, he felt 60% improvement of the lower extremities weakness and improvement in the speech. He had no respiratory difficulty, no palpitation. The patient stated that he had a mild URI with fever and chills about one week before the flu shot. PAST MEDICAL HISTORY: Fracture of right ankle in 4/00, symptoms of heart burn suspected of gastroesophageal reflux disease, history of bunionectomy in 1986 both sides, history of superficial isolation of the abdominal wall during childhood. FAMILY HISTORY: Mother deceased at age of 42 of CA uterus and rectum. Father deceased at age 27 with melanoma, strong family history of diabetes mellitus and stroke. The patient does not smoke, does not drink alcohol. He works at a plastic company. PHYSICAL EXAMINATION: Vital signs are stable. The patient was conscious, alert, oriented, cranial nerves intact. He complained of weakness of both legs but on the physical examination, he was ambulatory, no weakness noted, deep tendon reflexes normal, Babinski negative. Lungs are clear. Heart with regular sinus rhythm, no peripheral edema. On 2/8, the patient's symptoms recovered completely 100%. He ambulated around ICU and speech was clear. Discussed with neurology and felt that the patient can be discharged. ASSESSMENT: Diagnoses as mentioned above.			Y	Y	Y	2			Y	02/01/2001	02/03/2001	2	Urea N results, Creatinine results 1.4 MG/DL, Sodium results 140MMOL/L, Potassium results 3.7 mmol/L, Chloride results 104.1 mmol/L, CO2 results 27 mmol/L, Protein Total results 6.2, Albumin results 3.5 gm/dl, Bilirubin results .4 mg/l, AST results 19 iu/l, Alt results <24 iu/l, Alkphos results 88 IU/L, GGT Results <32 IU/L	PUB	PUB	Ranitidine, Naprofen, Prochlorphrazine maleate	NONE	Sinus bradycardia, gastroesophageal reflux disease, bunionectomy, superficial isolation of the abdominal wall during childhood			1						1	Aphasia; Back pain; Dysarthria; Guillain-Barre syndrome; Muscular weakness; Musculoskeletal stiffness; Pyrexia; Urinary tract infection	FLU3~SANOFI PASTEUR~E71740LA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0187836	07/19/2002	DC	1.3	1	.3	M	07/18/2002	In addition to the symptoms listed on the info sheets, 48 hours after the vaccinations, pt is suffering with a bad runny nose, vomiting, loss of appetite, coughing and a sore throat.  He also cries and whimpers a lot.  He also has a fever and has had had jerky spasms at night.									U	07/16/2002	07/16/2002	0		PVT	PVT						1						1	Agitation; Anorexia; Cough; Dyskinesia; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea; Vomiting	FLU3~PFIZER\WYETH~485046~4~IM~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|MMR~MERCK & CO. INC.~0736L~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0982L~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0187995	07/24/2002	MN		53		F	06/04/2002	A 54 year old female patient reported that, two years ago in October 1999, she received a dose of influenza virus vaccine, manufacturer unknown (1999-2000 Formula) and developed an injection site reaction characterized by redness, swelling and hot to the touch.  She recovered.  The reporter indicated that she has an allergy to egg whites, soy beans, multiple food allergies and multiple antibiotic allergies.  She recovered.  Follow up information received on 05/29/2002 from her physician stated that her patient has been on immunotherapy for about 15 years.  The information provided confirmed that she has a lot of allergies to foods, antibiotics EGG allergy and soybean allergy.  The patient still smokes cigarettes.  At times she has experienced tingling of her lips and tongue and her throat itches if she inadvertently eats foods to which she is allergic.  Medical notes mentioned that she develops local injection site reactions from the immunotherapy itself.									Y	10/01/1999	10/01/1999	0		OTH	OTH			Cigarette smoker; Hypersensitivity NOS		HQ841451NOV2001	1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0188092	07/29/2002	NE	62.0	62		F	07/22/2002	Information has been received from a 62 year old female consumer who on 10/10/98 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown). Concomitant therapy that same day included a dose of influenza virus vaccine (manufacturer not reported). The patient stated that she was vaccinated with a vaccine for pneumonia and flu (combination pneumonia flu vaccine). She stated that she immediately started to feel ill after taking the medication. She also stated that she died 3 times the following day and had to be revived. She noted that she was hospitalized. Additional information has been requested. Follow up information was received from the patient concerning her experience of sudden death in October 1997 after receiving pneumococcal vaccine 23 polyvalent. The patient had very possible damage to heart a year before from radiation therapy for a small breast tumor that was malignant. The patient naoted that she was also asthmatic. The patient had told her physician that she had problems with flu shots in the past. The patient stated that this experience was ruining my life and that of my families. The patient mentioned two other patients that had heart problems after vaccine. Per 60 day follow up: pt has not recovered. Heart stopped 3 times. Severly damaged.				Y	Y				Y	10/10/1998	10/10/1998	0		OTH	OTH			Heart injury; Breast cancer; Radiotherapy; Asthma		WAES0207USA01455	1						1	Cardiac arrest; Cardiac failure; Cardiomyopathy; Malaise; Respiratory arrest; Malaise; Myocardial infarction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0188105	07/29/2002	MD	30.0	29		F	07/15/2002	Additional information received from the physician 07/03/02, included recovery status of thepatient and a  further description of the adverse  events. A nurse reported that she inadvertently received a subcutaneous injection of Flu Shield instead of PPD. On 5/3/02, she developed a tender wheal at the injection site. the patient recovered approximately 72 hours later. MANUFACTURER'S Comment: Flu shield (2001-2002 Formula was maladministrered to this patient, as well as several other patient. See related report: HQ2190007MAY2002.				Y					Y	05/02/2002	05/03/2002	1	No test performed	OTH	OTH	NONE	UNK	NKA		HQ2289413MAY2002	1						1	Injection site urticaria; Medication error	FLU3~PFIZER\WYETH~~UNK~SC~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0188156	07/30/2002	AR	71.0	70		M	06/13/2002	Pt states he received flu shot 11/29/01 and then experienced decreased strength and flexibility in left arm about 2 wks post vaccine. Did not consult MD. Was in MUA 02/25/02 with resulting injury to chest and face. Has been doing weight lifting to strengthen arms and strength has improved but still c/o decreased flexibility.									N	11/29/2001	12/15/2001	16	NONE	PUB	PUB	ASA, Verapirial, HETZ, Diurelic		CVA syrsago, heart condition (atrial fib)		AR0227	1						1	Asthenia; Hypokinesia	FLU3~SANOFI PASTEUR~U0705AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178004	08/02/2002	WI	26.0	26		F	07/30/2002	Information has been received from an RN concerning a 26 year old female pt who on 11/1/01 was vaccinated IM, in the left deltoid, with the 1st dose of pneumococcal vaccine 23 polyvalent (lot 636158/1456K). Concomitant therapy that same day, included the 1st dose in the right deltoid of influenza virus vaccine (Fluzone) (lot U0682AA). On 11/2/01, the pt experienced a painful arm, developed a fever and her arm became swollen and red from the injection site to the elbow. The pt was seen by a physician on 11/5/01, dx'd with staph infection and started on antibiotics. Therapy with antibiotics was started on 11/6/01 and at the time of the report, it was unknown if the pt recovered. No culture was performed to confirm staph infection. The RN also reported that another female pt experienced pain and swelling when vaccinated with the same lot (WAES 01110739) (lot 636158/1456K). Additional information is not expected.				Y					U	11/01/2001	11/02/2001	1	NONE	PUB	PVT			UNK		WAES01111484	1						2	Bacterial infection; Injection site erythema; Injection site pain; Injection site swelling; Pyrexia	FLU3~SANOFI PASTEUR~U0682AA~1~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1456K~1~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0188297	08/02/2002		80.0			M	10/17/2002	A pharmacist reported that an unidentified 80 year old male received Flu Shield (2000-2002 formula) vaccine in December 2001. Subsequent to immunization, the pt claims he developed heart attack, stroke and pneumonia (date not identified). The caller (pharmacist) refused to provide any additional info. This case was considered serious since heart attack and stroke were considered medically important (OMIC).									U	12/01/2001			UNK	OTH	OTH	UNK	UNK	UNK		3540731	1						1	Cerebrovascular accident; Myocardial infarction; Pneumonia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0188339	08/02/2002	PA		44		F	07/30/2002	Information has been received from a female with a history of laceration and a September, 1997 diphtheria toxoid allergy resulting in muscle pain (myalgia) and inability to move her neck (neck disorder). In October, 1997, she was vaccinated with a dose of pneumococcal vaccine 23 polyvalent Concomitant therapy that same day included a dose of influenza virus vaccine. It was reported that ever since she received these three vaccines the patient has experienced a variety of health problems, including shortness of breath, flu-like symptoms, coughing w/out mucous, muscle spasms throughout her body, some swelling in her feet blurred vision, hair loss, enlarged lymph nodes, lots of chest pain, numbness in extremities and tingling in her extremities. The patient sought medical attention. Additional information has been requested.				Y					U	10/01/1997			UNK	OTH	OTH			Medical History: allergy to vaccine; laceration; Musculoskeletal disorder; Myalgia		WAES01080721	1						1	Chest pain; Cough; Dyspnoea; Hypoaesthesia; Hypotrichosis; Influenza like illness; Lymphadenopathy; Muscle spasms; Oedema peripheral; Paraesthesia; Vision blurred	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0188349	08/02/2002					F	07/30/2002	Information has been received from a health professional concerning a female patient who on 11/20/00 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the patient experienced swelling and pain where she was vaccinated. On 9/20/01, the patient reported that she was still experiencing pain and swelling where she was given pneumococcal vaccine 23 polyvalent. She also reported that she had recently been told that she had arthritis in that shoulder. Unspecified medical attention was sought. Follow up information from the registered nurse reported the office records indicate that patient received a dose of the flu vaccine in the left arm, but the patient reports that she received pneumococcal vaccine 23 polyvalent. The RN reported that the influenza vaccine could have been responsible for the reaction. No further information is available.				Y					N	11/20/2000				OTH	OTH			Unk		WAES01092369	1						1	Injection site oedema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0188356	08/02/2002	IN	14.0	14		F	07/30/2002	Information has been received from a physician concerning a 14 year old white female with mild asthma who on 09 OCT 2001 (also reported as 10 OCT 2001) was vaccinated with a seventh dose of pneumococcal vaccine 23 polyvalent (lot # 479567, invalid) IM in the right arm and influenza virus vaccine in the left arm. Concomitant therapy included fluticasone propionate, salmeterol xinafoate, and albuterol. On 09 OCT 2001 (also reported as in the evening of 11 OCT 2001), the patient developed extreme tenderness and a blotchy, erythematous rash around the injection site of the pneumococcal vaccine. By the morning of 12 OCT 2001, the patient's right arm was so sore that hte patient could not use that arm. The physician reported that the patient subsequently recovered on 19 OCT 2001. No additional information is expected.				Y					Y	10/09/2001	10/09/2001	0		PVT	OTH	Albuterol, ADVAIR		Asthma NOS		WAES01101790	1						1	Injection site oedema; Injection site reaction; Rash erythematous	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~7+~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0188360	08/02/2002		53.0	53		F	07/30/2002	Information has been received from a health care professional concerning a 53 year old female patient with allergies to ampicillin, cephalexin and cefaclor which result in canker sores and a history of hypercholesterolemia who on 17 OCT 2001 was vaccinated in the right arm with a dose of pneumococcal vaccine 23 polyvalent (lot #636158/1456K). Concomitant therapy included a dose of influenza virus vaccine given in the left arm. On 18 OCT 2001 the patient experienced chills, sweats and a temperature of 99F. on 19 OCT 2001 the patient experienced redness, slight swelling and pain from her right scapula to elbow with blotchy patches of redness on the inner aspect of her arm. The patient sought unspecified medical attention. It was reported that the patient was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown) 8 to 10 years ago without incident. There was no evidence of discomfort on the patient's left arm where she received the influenza virus vaccine. Additional information has been requested.				Y					N	10/17/2001	10/18/2001	1		OTH	OTH			Hypercholesterolaemia; Drug allergy; Specific allergy (drug)		WAES01102738	1						1	Chills; Erythema; Hyperhidrosis; Pain; Pyrexia; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1456K~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0188364	08/02/2002	HI	53.0	53		F	07/30/2002	Information has been received from a physician concerning a 53 year old white female with hypertension, hypothyroidism, Sjogren's Syndrome, fibromyalgia, GERD, allergic rhinitis and menopause who on 10/10/01 at 10:30 was vaccinated IM in the left deltoid, with a dose of pneumococcal vaccine 23 polyvalent (lot 636158/1456K). Concomitant vaccination the same day included a dose of influenza virus vaccine (Fluzone) (lot U0573AA) given IM in the right deltoid. At the time of vaccination, the pt was experiencing constipation and oral thrush. On 10/11/01, at 10:15, the pt developed erythema and induration at the left deltoid injection site. The pt sought medical attention and the pt subsequently recovered. It was also reported that another pt (WAES 0112USA02132) had a similar experience following exposure to pneumococcal vaccine 23 polyvalent. No further information is available.				Y					Y	10/10/2001	10/11/2001	1		PVT	PVT		Constipation; oral candidiasis (thrush)	Fibromyalgia; GERD; Hypertension NOS; Hypothyroidism; Menopause; Allergic rhinitis NOS; Sjogren's Syndrome		WAES01103103	1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1456K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0188365	08/02/2002					F	07/30/2002	Information has been received from an NP concerning a female pt who on approx. 10/23/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included a dose of influenza virus vaccine. Subsequently, the pt experienced nausea and vomiting. Unspecified medical attention was sought. Additional information has been requested.				Y					U	10/23/2001	10/23/2001	0		OTH	OTH			UNK		WAES01103348	1						1	Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0188375	08/02/2002					F	07/20/2002	Information has been received from a pharmacist and an LPN concerning a white female with asthma who was vaccinated IM, in the right deltoid, with a 0.5ml dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included a 0.5ml dose in the left deltoid of influenza virus vaccine. Other concomitant therapy included Serevent (2 puffs BID beginning on 10/12/01), Pulmicort, turbohaler (200mg QD beginning 10/12/01) and albuterol inhaler (2 puffs Q4hr PRN beginning 9/24/01. The pt reported that 2 hours after the immunization in her right arm, in the area where the shot was given, began to swell, become red and painful. The pt was seen in the physician's office the next day with a swollen, warm and red upper arm. The pt was treated with (Solu-Medrol) 125mg, prednisone 20mg, po, QD X 2 days, Benadryl 25mg, Q6 hours, PRN and instructed to use over-the-counter ibuprofen 400mg Q6 hours and to call if there was no improvement or if the condition worsened. The pharmacist reported on another pt (WAES 01110662). Additional information has been requested.				Y					U					OTH	OTH	Serevent; Pulmicort turbohaler; albuterol inhaler		Asthma NOS		WAES01110021	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0188381	08/02/2002	CT	42.0	42		M	07/30/2002	Information has been received from an RN concerning a 42 year old Caucasian male physician who on 11/1/01 at 10:00, was vaccinated SC in the right arm with the 1st dose of pneumococcal vaccine 23 polyvalent (lot 640981/1050L). Concomitant therapy that same day at 10:00, included the 1st dose IM in the left deltoid of influenza virus vaccine (Fluzone) (lot 00694AA). Subsequently, on 11/2/01 at 08:00, the pt developed red swelling, hot to touch, hard from injection, pain from injection, low-grade fever and general joint aches from right arm injection site to the elbow. The physician was treated with 2 tablets of Vicodin for the pain. The pt recovered on 11/5/01. The nurse felt that the physician's low-grade fever and joint aches were related to the flu vaccine. The nurse reported 2 other cases of injection site swelling and redness (lot 640981/1050L) (WAES 01111735 and 01111376). Additional information is not expected.				Y					Y	11/01/2001	11/02/2001	1		OTH	OTH			UNK		WAES01110500	1						1	Arthralgia; Injection site erythema; Injection site induration; Injection site pain; Injection site swelling; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~00694AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1050L~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0188383	08/02/2002	MN	61.0	61		F	07/30/2002	Information has been received from a pharmacist concerning a 61 year old Caucasian female pt with an allergy to Duricef and a history of a local reaction to TD in 1999 who in 1995 was vaccinated with the 1st dose of pneumococcal vaccine 23 polyvalent. On 10/30/01, the pt was vaccinated with the 2nd dose of pneumococcal vaccine 23 polyvalent IM in the left thigh (1st number 637261/1067K) and influenza virus vaccine (Fluzone) IM in the right thigh (lot U0600AA). Other concomitant therapy included glucosamine, enalapril maleate, Tums, estradiol, Darvocet and an unspecified medication. Within 24 hours, on 10/31/01, the pt developed a site reaction on the left thigh about 6 in diameter with warmth, redness, swelling, inflammation and pain. The symptoms occurred only on the left thigh, which was the injection site of pneumococcal vaccine 23 polyvalent. The pt also had a swollen face and some swelling and numbness of her mouth, tongue and lips. The pt was started on prednisone 40mg X 10 days. The pt had previously tried Benadryl with little results. The pt's symptoms resolved on 11/14/01. No additional information is expected.				Y					Y	10/30/2001	10/31/2001	1		PVT	PVT	Unspecified therapy; Darvocet N; Tums; Vasotec; estradiol, glucosamine		Injection site reaction NOS; Allergy to Duricef		WAES01110514	1						1	Hypoaesthesia oral; Injection site erythema; Injection site inflammation; Injection site pain; Injection site swelling; Injection site warmth; Swelling face	FLU3~SANOFI PASTEUR~~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1067K~2~IM~LL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0188384	08/02/2002		76.0			F	07/30/2002	Information has been received from a physician concerning a 76 year old female who on 11/1/01 was vaccinated SC with pneumococcal vaccine 23 polyvalent. Concomitant vaccination included influenza virus vaccine. On 11/5/01, the pt developed a swollen arm and on 11/6/01, the pt became nauseated and vomited. It was also reported that on an unspecified date, the pt became lightheaded and dizzy and felt tired. The pt sought unspecified medical attention. At the time of this report, the outcome of the events was unknown. Additional information has been requested.				Y					U	11/01/2001	11/05/2001	4		OTH	OTH			UNK		WAES01110692	1						1	Dizziness; Fatigue; Injection site reaction; Injection site swelling; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~SC~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0188388	08/02/2002	CT	83.0	83		F	07/30/2002	Initial and follow-up information has been received from an RN concerning  an 83 year old retired Caucasian female pt with insulin-dependent diabetes mellitus and no known allergies who on 11/2/01 at 14:00, was vaccinated SC in the right arm, with the 1st dose of pneumococcal vaccine 23 polyvalent (lot 640981/1050L). Concomitant therapy that same day at 14:00, included the 1st dose IM in the left deltoid, of influenza virus vaccine (Fluzone) (lot U0694AA). There were no illnesses at the time of vaccination. Subsequently, on 11/4/01 at 11:00, the pt developed red, hot, hard swelling 3-4 from the elbow to site of injection. The event was described as erythema 3-4 below the injection site (around elbow area) that was hot to the touch. It was noted that there was no pain and that the pt was afebrile. Cellulitis was suspected and antibiotics were prescribed. On 11/4/01, therapy with erythromycin, 500mg po every 6 hours was started for 24 hours. Therapy with dicloxacillin 250mg po every 6 hours for 7 days was also started. An X-ray of the right elbow was performed on 11/5/01, which showed no fracture. The pt recovered on 11/8/01. The nurse reported 2 other cases of injection site swelling (lot 640981/1050L) (WAES 01110500, 011111376). Additional information is not expected.				Y					Y	11/02/2001	11/04/2001	2	X-ray of right elbow on 11/5/01-no fracture	OTH	PUB		NONE	IDDM		WAES01111375	1						1	Cellulitis; Erythema; Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U0694AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1050L~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0188389	08/02/2002	CT	91.0	91		F	07/30/2002	Information has been received from an RN concerning a 91 year old Caucasian female pt with a sulfa and penicillin allergy who on 11/2/01 at 14:00, was vaccinated SC, in the right arm, with a 1st dose of pneumococcal vaccine 23 polyvalent (lot 640577/0995L). Concomitant therapy that same day, at 14:00, included the 1st dose IM in the left deltoid, of influenza virus vaccine (Fluzone) (lot U0694AA). Subsequently on 11/3/01, at 10:00, the pt developed a 5cm circular erythema about 48 hours post vax. The pt recovered from the erythema on 11/6/01. Unspecified medical attention was sought. The nurse reported 2 other cases of injection site swelling (lot number 640577/0995L) (WAES 01110500 and 011111375). Additional information has been requested.				Y					Y	11/02/2001	11/03/2001	1		OTH	PUB			Allergy to Penicillin and sulfa		WAES01111376	1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U0694AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0995L~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0188391	08/02/2002		31.0	31		F	07/30/2002	Information has been received from a health professional concerning a 31 year old female who was vaccinated with pneumococcal vaccine 23 polyvalent (dose unknown) (lot 636158/1456K). Concomitant therapy, that day, included influenza virus vaccine. On 11/7/01, the pt developed signs of bruising and a large nodule at the injection site. The pt did not complain of pain. The pt was monitored for 10 minutes while an ice park was applied and ibuprofen administered. At that time, the pt's nodule went down a little bit. As of 11/12/01, the pt's nodule was still present and there was still a small amount of bruising. Additional information has been requested.				Y					N	11/07/2001	11/07/2001	0		OTH	OTH			UNK		WAES01111423	1						1	Contusion; Injection site mass; Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1456K~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0188392	08/02/2002		67.0	67		M	07/30/2002	Information has been received from an MA concerning a 67 year old male who on 11/12/01 was vaccinated with the 1st dose of pneumococcal vaccine 23 polyvalent (lot 637487/1071K) in the arm. Concomitant therapy that day, in the opposite arm, included a flu vaccine. At the pneumococcal vaccine 23 polyvalent injection site, the pt had pain, bruising and a nodule about 20 minutes after being vaccinated. The pt sought unspecified medical attention. Additional information has been requested.				Y					U	11/12/2001	11/12/2001	0		OTH	OTH			UNK		WAES01111424	1						1	Contusion; Injection site mass; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1071K~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0188448	08/05/2002	NY	71.0	71		F	07/30/2002	Information has been received from a 71 year old Caucasian female consumer with hypertension, sulfa allergy (rash, nausea) and degenerative joint disease who on 11/14/2001 at 14:30 was vaccinated IM in the right deltoid with the first dose (lot number 1497K reported, invalid for the product) of pneumococcal vaccine 23 polyvalent. Concomitant therapy on 11/14/2001 included a dose in her thigh of influenza virus vaccine (manufacturer not reported). Additional concomitant therapy included ramipril (ALTACE) and estrogens, conjugated (PREMARIN). On 11/14/2001 at 17:00 the patient developed pain at the injection site and her arm became swollen and painful from her shoulder to her elbow, and then down into her forearm. She reported that her arm was red, inflamed and sore. She noted that as of 11/20/2001, her arm seemed to be better. Unspecified medical attention was sought. Follow up information received from a woman in the physician's office indicated that the patient developed a localized reaction characterized by redness and swelling. She also indicated that there was soreness at the injection site in the patient's right deltoid. No further information is available.				Y					Y	11/14/2001	11/14/2001	0		PVT	PVT	Premarin, Altace		Nausea, Rash NOS, Degenerative joint disease, drug hypersensitivity, hypertension NOS		WAES01112825	1						1	Erythema; Injection site inflammation; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0188453	08/05/2002	WA	72.0	72		M	07/30/2002	Information has been received from a registered nurse concerning a 72 year old Caucasian male with asthma, heart disease, a morphine allergy, an intolerance to lorezapam (Ativan), poor circulation and a history of bypass to leg. On 11/6/01 at 10:00 am the patient was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (lot # 640744/0994L), in the right deltoid. Concomitant therapy that day included a flu vaccine. There was no illness at the time of vaccination. It was reported that on 10/11/94 the patient received the first dose. The second dose does not comply with the recommended dosage schedule. The patient reportedly within one to two hours, after the second dose, felt weak and had chills with receipt of the vaccine. The patient also had chest tightness and thought a heart attack. He took two aspirin and the chest pain went away. Later that night, his arm was very sore and swollen, also described as tightly swollen. The patient developed a severe local reaction at the injection site described as red, tender, swollen and painful. It was reproted that the symptoms started to get better the next day. However, the arm began to swell and he had more painful discomfort, described as very sore. The discomfort gradually diminished over 4 days. It was reported that the entire episode lasted for two weeks. The patient sought unspecified medical attention and recovered on 11/20/01/ It was noted that when flu shots first came out the patient became very ill after the first dose of the two dose series. No further information is expected.				Y					Y	11/06/2001	11/06/2001	0		PUB	PVT			Femoral artery bypass, Asthma NOS, Cardiac disorder NOS, Specific allergy (drug), Hypersensitivity NOS, Cardiovascular disorder NOS		WAES01114250	1						1	Asthenia; Chest discomfort; Chills; Erythema; Injection site reaction; Injection site swelling; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0994L~2~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0188456	08/05/2002		47.0	46		F	07/30/2002	Information has been received from a licensed practical nurse concerning a 47 year old female patient who on 10/12/01 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy on 10/12/01 included an injection of phytonadione (dose not reported) in the right arm and a dose of influenza virus vaccine (manufacturer not reported) in the left arm. It was unknown if there were any other concomitant therapies. It was reported that the patient was treated for abut 17 days by her primary physician (event onset approximately 11/12/01), and that cellulitis was ruled out. The patient presented to the reporters office on 11/29/01 with a red rash on her left arm. Additional information has been requested.				Y					U	10/12/2001	11/12/2001	31		OTH	OTH	Mephyton		Unk		WAES01120056	1						1	Rash erythematous	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0188603	08/07/2002	HI	67.0	67		F	07/30/2002	Information has beenr eceived from a physician concerning a 67 year old white female with allergies to sulfa and celecoxib (CELEBREX), who has coronary artery disease, asthma and hyperlipidemia and a history of a myocardial infarction, a rash while on therapy with glucosamine and a dysrhythmia while on therapy with chlorpheniramine tannate, phenylephrine tannate, pyrilamine tannate (RYNTANA) who on 10/11/2001 at 09:00 was vaccinated with pneumococcal vaccine 23 polyvalet (lot #636158/1456K). Concomitant therapy, that same day, included influenza virus vaccine. On 10/12/01, the patient developed erythema, induration and increased warmth to the injection site. The patient sought medical attention in her physician's office. Subsequently, the patient recovered. Additional information is not expected.				Y					Y	10/11/2001	10/12/2001	1		PVT	PVT			Arrythmia NOS, Myocardial infarction; Rash NOS, Asthma NOS; Specific allergy (drug), coronary artery disease NOS, drug hypersensitivity; hyperlipidemia NOS		WAES0112USA02132	1						1	Feeling hot; Injection site erythema; Injection site induration	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1456K~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0187108	08/08/2002	AZ	50.0	50		F	06/27/2002	Developed laryngitis ans bronchitis 12/08/01.  Fell at work then startd exeperiencing pain in legs by 12/11.  Bronchitis worse and went to ER, had breathing treatment and IV.  Leg pains continued to become worse.  New Year's eve noticed bruise on rt. hip attributed to prednisone.  Had 4 falls in Dec.  Has had followup with Dr.  Referred to Dr. - appt. 7/23/02.  Diagnosed with perenial palsy, has leg braces, PT, poss. Guillian-Barre syndrome. Per follow up: Pt did not recover. 01/02/2003 Still recovering: Brain scan neg. Had back x-ray and MRI of back. Continues under care of neurologist who had told her he feels she will be OK. Legs continue to twitch at night. Is able to walk with assistance.			Y	Y					N	12/05/2001	12/06/2001	1	Brain scan - neg; back x-ray, MRI of back.	PUB	PUB		None	Bronchitis		AZ0218	1						2	Anxiety; Bronchitis; Depression; Dyskinesia; Guillain-Barre syndrome; Laryngitis; Muscular weakness; Bronchitis; Contusion; Difficulty in walking; Guillain-Barre syndrome; Laryngitis; Muscle twitching; Pain	FLU3~SANOFI PASTEUR~U0696AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U0696AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0994L~UNK~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Life Threatening	Influenza
0188628	08/08/2002	TX	2.25	2	.3	U		My daughter was given the following vaccines on 07/10/01: (1) DTaP, Tripedia, (2) Influenza, (3) hepatitis B. All these vaccines continued Thimerosal, the very next day after the vaccines were given, my daughter had seizures. I have a detailed contemporaneous medical record that explain in detail this vaccine injury and the medical expert linked the mercury in thimerosal vaccine or causing my daughter permanent injuries. My daughter had a serious vaccine reaction that cannot be overlooked. I was informed to contact you because you monitor the safety of licensed vaccines. The attached medical report clearly reflects that the adverse event occurring after vaccination was actually caused by the vaccination. On 07/11/01, the next day after pt received the vaccines, pt began having seizures and was admitted to hospital from 07/11/01 to 07/14/01 and treated by a neurologist. It was determined that pt was having seizures diagnosed as infantile spasms, which continued until 9/25/01 and permanently injured pt. Pt is blind in both eyes and deaf in both ears and mentally retarded caused by the infantile spasms. Diagnosis: blind, deaf, mentally retarded, autism. The dangerous mercury levels combined in all vaccines given o pt on 07/10/01 caused pt's immediate seizures the next day on 07/11/01. Pt was experiencing a normal childhood development until 07/10 & 11/2001, such drastically changed after receiving the vaccines containing Thimerosal. Pt demonstrated autistic like symptoms (infantile spasms) after receiving the injections, such infantile spasms.					Y	4		Y	N	07/10/2001	07/11/2001	1	Pt's hair was tested in which pt had a mercury level of 4.9ppm, which is well above the environmental protection agency 1ppm action level for mercury toxicity. Pt has not been exposed to any heavy metals, lead paint or consumed fish. Hair was tested via a technique called neutron activation analysis to detect various chemicals in hair.	UNK	UNK			NONE			1						1	Autism; Blindness; Convulsion; Deafness; Drug toxicity; Infantile spasms; Mental retardation severity unspecified	DTAP~SANOFI PASTEUR~~UNK~IM~~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~~HEP B (ENGERIX-B)~1	USA	Hospitalisation,Disabling	Influenza
0180332	08/12/2002	MI	68.0	68		F	07/30/2002	Information has been received from a registered nurse concerning a retired 68 year old Caucasian female patient with a history of shoulder disorder who on 11/11/01 at 09:20 was vaccinated IM in the right arm with the first 0.5 mL dose of pneumococcal vaccine 23 polyvalent (lot number 640577/0995L). Concomitant vaccination on 11/11/2001 at 09:20 included the first dose of influenza virus vaccine (FLUZONE) IM in the left arm (lot number U0703AA). The patient had no illnesses at the time of vaccination. On 11/12/01 at 13:30 the patient complained of a sore spot and stated that she could not lift her arm. The patient stated that it was immobilized. The arm was not swollen or red, and there was no lump. The patient was advised to apply ice and heat. The patient was seen by her rheumatologist and a chiropractor. On 11/15/01 the patient stated that the arm was better and that she could use her arm, however, she still had some weakness. In follow up it was reported that the patient's physician thought that the patient may have also had pruritus in the arm. No further information is expected.				Y					Y	11/11/2001	11/12/2001	1		OTH	PVT			Unspecified disorder of joint of shoulder region.		WAES0201USA02183	1						2	Hypokinesia; Pain; Joint range of motion decreased; Myalgia	FLU3~SANOFI PASTEUR~U0703AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0995L~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U0703AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0995L~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0180333	08/12/2002	MI	39.0	39		M	07/30/2002	Information has been received from a health professional concerning a 39 year old white male who on 10/17/01 at 9:00 am was vaccinated with pneumococcal vaccine 23 polyvalent in the left arm. Concomitant therapy included influenza virus vaccine (Fluzone). That evening, the patient experienced a sore left arm, stiffness, and difficulty lifting his arm. On 11/26/01, the patient reported his arm was still 'a little sore and he still had difficulty raising his arm above his head. There was no swelling, redness or a lump noted. The patient was instructed to call back or see a physician if the problem persisted. As of 01/15/02, the patient had not called back. The patient did not seek medical attention. Additional information is not expected.									U	11/17/2001	11/17/2001	0		OTH	PVT		UNK	UNK		WAES0201USA02043	1						2	Hypokinesia; Pain; Joint range of motion decreased; Musculoskeletal stiffness; Myalgia	FLU3~SANOFI PASTEUR~U0703AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0996L~UNK~IM~~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0180334	08/12/2002	MI	71.0	71		F	07/30/2002	Information has been received from a registered nurse concerning a 71 year old female patient who on 10/30/01 at 11:00 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot number 637345/1449K) IM in the left arm and a dose of influenza virus vaccine (FLUZONE) (lot number U0600AA) IM in the right arm. On 10/31/01 at 08:00 the patient developed redness and swelling in the left arm. The patient was seen by her physician and was prescribed amoxicillin trihydrate, clavulanate potassium (AUGMENTIN) 875mg, two tablets daily for cellulitis. On 1/8/02, the cellulitis resolved. Additional information is not expected.				Y					Y	10/30/2001	10/31/2001	1	None	OTH	PVT			Unk		WAES0201USA02044	1						2	Cellulitis; Injection site erythema; Injection site swelling; Cellulitis; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1449K~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1449K~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0180486	08/12/2002	MI	51.0	51		F	07/30/2002	Information has been received friom a registered nurse concerning a 51 year old female who on 10/27/01 was vaccinated with pneumococcal vaccine 23 polyvalent, IM injection  (Lot # 637345/1449K). Concurrent therapy included influenza virus vaccine (Fluzone), IM injection, with which the patient had been vaccinated in the same arm earlier that same day at a different clinic. On the evening of 10/27/01,the patient experienced redness, swelling, and pain at the injection site; she also felt a knot, and a rash appeared. The patient did not see a physician; on 11/05/01, the patient still had a pin-size knot , with no redness. On that date, the patient  was considered to be recovered with no problems. The knot,rash and injection site swelling, redness, and pain were all considered to be non-serious. Additional information is not expected.									Y	10/27/2001	10/27/2001	0		OTH	PVT			NKA		WAES0201USA02045	1						2	Injection site erythema; Injection site mass; Injection site pain; Injection site swelling; Injection site erythema; Injection site pain; Injection site swelling; Rash; Skin nodule	FLU3~SANOFI PASTEUR~U0685AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1449K~UNK~IM~~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1449K~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0180714	08/12/2002	MI	74.0	74		F	07/30/2002	Information has been received from a health professional concerning a 74 yr old female who on 10/27/2001 at 0700 was vaccinated IM in the right arm with a 0.5ml dose of pneumococcal vaccine 23 polyvalent (lot number 637345/1449K). Concomitant vaccination the same day included a dose of influenza virus vaccine (Fluzone) (lot number U0685AA) given IM in the left arm. There was no illness at the time of vaccination. On 10/23/2001 at 0900 the pt developed a large red spot below injection site. Itchy redness spread almost to her elbow and under her arms. No swelling was noted. She applied ice all day. On 10/25/2001 the symptoms decreased. On 10/26/2001, the pt recovered. Additional information has been requested. A 15-day follow up report received 8/5/2003 adds: (onset of large red spot) was on 10/24/2001 at 9 am. ...It was reported that most symptoms resolved and the pt recovered on 10/26/2001. No further info is expected.									Y	10/22/2001	10/23/2001	1	NONE	OTH	PVT			UNK		WAES0201USA03378	1						2	Erythema; Injection site erythema; Pruritus; Injection site erythema; Pruritus	FLU3~SANOFI PASTEUR~U0685AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1449K~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~637345/1449K~UNK~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0184128	08/12/2002	NY	52.0	52		M	07/30/2002	Information has been received from a 52 year old male with a history of lung cancer and no known allergies who two weeks ago (approximately 12/27/01) was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy that same day included a dose of influenza virus vaccine (manuf not reported). Other concomitant therapy included levothyroxine na (Synthroid), Dilantin, Axid, and folic acid. After he was vaccinated, the pt experienced pain in the pelvic area. It was noted that the pain eventually went away. It was reported that the pt has also been experiencing cold symptoms and a stuffy nose. Unspecified medical attention was sought. No further info is available.				Y					Y	12/27/2001	12/27/2001	0		OTH	OTH	Folic acid, Synthroid, Axid, Dilantin		Lung cancer		WAES0201USA00913	1						2	Cough; Sneezing; Nasal congestion; Pelvic pain; Pharyngitis; Rhinitis	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~~~PNEUMO (PNU-IMUNE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0188759	08/12/2002		72.0			F	07/30/2002	Information has been received from a pharmacist concerning a 72 year old female who on 12/5/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (invalid lot 8030L reported) (site unknown). Concomitant therapy on 12/5/01 included a dose of influenza virus vaccine (site unknown). The pt developed a local reaction that same day, the pharmacist referred to the reaction as an injection site reaction. It was noted that she was afebrile. No past vaccination information was available. No treatment was needed, but the pt sought unspecified medical attention. Additional information has been requested.				Y					U	12/05/2001	12/05/2001	0		OTH	OTH			UNK		WAES0202USA01360	1						1	Injection site reaction; Unevaluable event	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~8030L~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0176787	08/15/2002	IN				F	08/13/2002	A female consumer reported that she received Flu Shield vaccine on 1/22/01 in her left arm. Concomitant with vaccine administration, she experienced inflammation with stiffness on her left arm. Two hours post-immunization she felt a know (nodule under her left arm. After awhile (exact time unk) she felt two more knots under her left arm, toward her back, she has also experienced tingling and pulling sensations in her left arm. Once while driving her left arm gave out and she was seen by her physician. She now has Carpal Tunnel Syndrome, nerve damage at the left elbow and burning sensation around the left shoulder blade. She was treated at the ER with a steroid shot (medication name and dose not identified by consumer). Currently she goes to physical therapy and is on a muscle relaxant (medication not identified by consumer). This case was serious since Carpal Tunnel Syndrome and nerve damage were considered medically important in this case. No additional info was available as of the date of this report.				Y					U	01/22/2001	01/22/2001	0	UNK	PVT	OTH	UNK	UNK	UNK		HQ3658608AUG2002	1						3	Oedema peripheral; Pain; Carpal tunnel syndrome; Injection site inflammation; Musculoskeletal stiffness; Nerve injury; Paraesthesia; Skin nodule	FLU3~PFIZER\WYETH~4008196~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2|FLU3~PFIZER\WYETH~4008196~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~3	USA	Emergency room visit	Influenza
0188950	08/15/2002	CA	79.0	79		M	10/17/2002	A 79 year male consumer received Flu Shield vaccine on 12/01/01. One week post-immunization, he developed pneumonia. In early Jan 2002, he experienced a heart attack and was hospitalized. In early Mar 2002, he experienced a stroke and was also hospitalized at that time. The stroke caused left sided weakness and speech impairment. He states his left eye in now larger. He is now taking warfarin sdium. No additional info was available as of the date of this report.				Y	Y				U	12/01/2001	01/01/2002	31	UNK	OTH	OTH	NONE	UNK	Myocardial infarction		HQ3658808AUG2002	1						1	Cerebrovascular accident; Eye disorder; Hemiparesis; Myocardial infarction; Pneumonia; Speech disorder	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0188971	08/16/2002	MA	22.0	22		M	07/13/2002	On 11/10/98, sudden onset of loss of feeling right side of face with right sided facial muscle paralysis. Dx as Bell's palsy. Treated with tapered course of oral Prednisone. Symptoms improved gradually over the next several months. Still with residual symptoms that when tired.									Y	11/08/1998	11/10/1998	2		MIL	MIL	NONE	NONE	Adverse reaction-sulfa, TNC, EES & PNC			1						1	Facial palsy; Flat affect	FLU3~SANOFI PASTEUR~970170~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0189023	08/19/2002	FL	45.0	45		F	08/15/2002	It was reported that a 45 year old female pt received a Fluzone vaccination administered on 10/28/2001 two possible lot numbers were provided U0445AA or U07008AA. The pt reported experiencing flu-like symptoms in January 2002. Physician saw her; numerous tests done-possible diagnosis of chronic fatigue syndromes. Symptoms are unresolved. From follow-up report returned by the pt on 08/02/02, it was reported that she received a dose of Fluzone on 10/28/01 at a walk-in clinic. On 01/23/02, she experienced shortness of breath, fever, sore throat, swollen glands, chest pain, muscle aches, joint pain, jaw pain, and extreme fatigue. Pt also requested a copy of the report to be sent to her physician. Upon receipt of this info this report was upgraded from non-serious to 15 day.  A 15-day follow up report received 09/30/2003 adds: From additional info received on 09/15/2003 from an office administrator, the reporting physician's new address and fax number were provided. No additional relevant info was obtained. Adverse event coding was updated, and the provisional diagnosis (not confirmed) - Chronic Fatigue Syndrome - was coded. Follow up on 11/05/2003: Case closure, on 10/27/2003.  A sixth attempt for follow up information was made on 09/15/2003, at which time the responsible physician was contacted via fax.  No response has been received.  No further information is anticipated, therefore, this case is closed.				Y				Y	N	10/28/2001	01/23/2002	87	EKG; CXR; CAT Scan; ECG; Cardiac Catheterization; Blood Work and cultures; VQ Scans; HIDA Scan; Stomach scope; Respiratory tests	PVT	PVT					U200200218	1						1	Arthralgia; Chest pain; Dyspnoea; Fatigue; Influenza like illness; Lymphadenopathy; Myalgia; Pain in jaw; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0189261	08/23/2002	MD	40.0	40		F	08/21/2002	A consumer reported that his 40 year old wife, who is a nurse, received Flu Shield (2000-2001 formula) (influenza virus vaccine, trivalent, types A & B) on 11 NOV 2000. Subsequent to immunization, she experienced injection site pain for about a week and then progressive neurological problems. She developed numbness and tingling, mostly in the right arm and leg, followed by confusion and stumbling. The husband reported that in JAN 2001, a neurologist said it could be from the vaccination but tried to rule out other things. At that time in JAN 2001, she had meningitis. The patient has improved, but not as quickly as expected by her physician. The husband states that his wife has been diagnosed with post-vaccinal encephalomyelitis. Twenty-one months post-immunization she finally felt better for about a week. However, as she increased her activity, the symptoms came back. This case was considered serious since post-vaccinal encephalomyelitis meningitis and neurological problems were considered medically important in this case.				Y					N	11/11/2000	11/22/2000	11	UNK	PVT	OTH	UNK	UNK	UNK		HQ3874520AUG2002	1						1	Confusional state; Encephalitis; Gait disturbance; Hypoaesthesia; Injection site pain; Meningitis; Nervous system disorder; Paraesthesia	FLU3~PFIZER\WYETH~4008185~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0189268	08/23/2002	VA	62.0	61		M	08/14/2002	Left arm hurts, at the spot of the shot when arm is used a certain way. Since shot was given this has been a problem. Went to doctor's on 08/12/02. He did not know what problem was. He prescribed medication. Go back on 09/02/02									N	11/30/2001				OTH	PVT	Cardura 8 MG for prostate	NONE				1						1	Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0189297	08/23/2002	NY				F	12/10/2001	A female consumer reported that she received influenza virus vaccine, trivalent, types a & b (1998-1999 formula). The pt's concurrent illnesses include hypersensitivity and eczema with a past history of asthma and bronchitis. Following the immunization, she developed a worse than normal skin reaction all over her body. The reporter noted that at the time of the event, she attributed these symptoms to the winter weather and dry skin. The consumer reported 2 similar occurrences following previous immunizations with a flu vaccine. See HQ8356213NOV2001 and HQ9120205DEC2001. No additional information was available as of the date of this report.									U				UNK	OTH	OTH	UNK	UNK	Asthma; Bronchitis; hypersensitivity and eczema		HQ9120305DEC2001	1						1	Injection site reaction; Unevaluable event	FLU3~PFIZER\WYETH~~UNK~SC~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0189298	08/23/2002	MT	55.0	54		F	12/10/2001	A nurse reported that a 55 year old female received an injection of Flu Shield (1998-1999 Formula). Subsequently, she developed an injection site reaction characterized by redness, soreness and warmth which extended to her elbow. The symptoms resolved in 5 days. This pt developed an injections site reaction following receipt of Flu Shield (1999-2000 Formula) and Flu Shield (2000-2001 Formula). See HQ8940328NOV2001 and HQ9179606DEC2001.									Y	01/01/1998			UNK	OTH	OTH	UNK	UNK	UNK		HQ9179806DEC2001	1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0189482	08/28/2002	MA	63.0			F	08/01/2001	A 63 year old female (now 75 years of age) reported that she received a dose of influenza virus vaccine (manufacturer unknown) in 1988, and subsequently developed an injection site reaction characterized by redness and swelling. She recovered. No further information was available at the time of the report. (See HQ3826430JUL2001).									Y				Unk	OTH	OTH	Unk	Unk	Unk	Local Reaction~Influenza (Seasonal) (no brand name)~~0.00~In Patient	HQ3896431JUL2001	1						1	Erythema; Injection site reaction; Injection site swelling	FLU3~PFIZER\WYETH~~2~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0189483	08/28/2002	MA	60.0			F	08/01/2001	A 60 year old female (now 75 years of age) reported that she received a dose of influenza virus vaccine (manufacturer unknown) in 1985, and subsequently developed an injection site reaction characterized by redness and swelling. She recovered. No further information was available at the date of the report. (see HQ3896431JUL2001).									Y				Unk	OTH	OTH	Unk	None	Unk		HQ3826430JUL2001	1						1	Erythema; Injection site reaction; Injection site swelling	FLU3~PFIZER\WYETH~~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0189504	08/28/2002	TN	54.0	54		F	11/07/2001	A nurse reported that a 54 year old female received an injection of Pnu-Imune 23 and Flu Shield (2001-2002 formula) on 10/30/01. The following day, she developed an injection site reaction characterized by redness and swelling extending to the elbow on the left arm. The pt was treated with ibuprofen, elevation of the extremity and application of heat to the area. The specific sites of vaccine administration were not reported.									U	10/30/2001	10/31/2001	1	UNK	PVT	OTH	Ambien; Azmacort; Bentyl; Caltrate; Combivent; Flonase; ibuprofen; Lescol; NTG; Persantine; Phenergan; Prozac; Tylox; Vitamin C	UNK	Migraine NOS		HQ8104206NOV2001	1						1	Injection site erythema; Injection site swelling	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~474941~UNK~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0189506	08/28/2002	NY	42.0			F	01/15/2002	A physician reported that a 42 year old female inadvertently received pneumococcal polyvalent and influenza virus, trivalent Types A & B vaccines mixed in the same syringe on 12/10/01 at a drug store clinic. Within a day of immunization, the pt developed a large, very painful injection site reaction characterized by redness, inflammation, induration and rash. She was prescribed unspecified antibiotics and NSAIDS. Additional information received from the physician on 1/11/02 indicated that 2 to 3 days, post vax, the pt fully recovered.				Y					Y	12/10/2001			NONE	OTH	OTH	NONE	UNK	UNK		HQ9475613DEC2001	1						1	Injection site erythema; Injection site induration; Injection site inflammation; Rash	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~IM~~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0189689	09/04/2002	WI	45.0	45		M	08/27/2002	Vomiting, fever, body aches, joint soreness, lack of energy. Duration of symptoms: approx 4 days. Pt saw Dr. at approx. 1 week after vaccination given.									Y	11/08/2001	11/09/2001	1		PUB	PUB			Cardiomyopathy, asthma, CHF, allergic to bees			1						1	Arthralgia; Asthenia; Pain; Pyrexia; Vomiting	FLU3~EVANS VACCINES~E02791HA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0189760	09/05/2002	GA				M	09/13/2002	An attorney reported that a male pt received injections of Tetramune (diphtheria and tetanus toxoids and pertussis vaccine adsorbed and haemophilus b conjugate vaccine (diphtheria crm197 protein conjugate)), Flu Shield (1999-2000 formula), and Flu Shield (2000-2001 formula) vaccines as part of his childhood immunizations. It is alleged that, as a result of the toxicity from the thimerosal and the mercury and/or other heavy metal in the vaccines, he had the following symptoms: severe learning disabilities, impairments in social relatedness, language and communication difficulties, abnormal movements, sensory dysfunction, depressions, anxiety, hearing loss, severe bowel dysfunction, and other severe health disorders. The reporter also stated that the pt was exposed to heavy metals from emissions from a chemical plant. These events were considered medically important. No further info was available as of the date this was reported.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ3986528AUG2002	1						1	Antisocial behaviour; Anxiety; Cognitive disorder; Depression; Drug toxicity; Gastrointestinal disorder; Hearing impaired; Movement disorder; Neurodevelopmental disorder; Sensory disturbance	DTPHIB~PFIZER\WYETH~428036~UNK~~~DTP + HIB (TETRAMUNE)~1|FLU3~PFIZER\WYETH~4998243~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0188092	09/06/2002	NE	61.0	61		F	08/28/2002	I had shots on Friday eve. right before Drs. office closed. I went home not feeling well. I thought it would leave. I awoke at 4am not feeling well. I cancelled 9am church meeting. I must have felt a little better and went and delivered B. Day cake. As we were coming home I had major heart attack and heart permanently damaged. Long medical history since shot mainly vaccine. My husband drove me to the fire station as we were close by. Diffibulators were new and fortunate for me the fireman was trained to use one. They called a rescue squad in, and I was taken to hospital. I had two more heart attacks that day, and have been told that I legally died three times. They put me into a coma as I badly needed to rest. After studying my heart, they decided to put an experimental pacemaker-diffibulator in me to save my life. I seemed to get along for about a year and meds were making me sick and I became semi invalid. The only places I went to was to drs. and hospitals. It is my understand that one MD was to report the problem that I had with that vaccination. I understand that he did not do this. They claim to have no record of the name of the Co. or any other information. MD was notified as soon as possible about my reaction to the shot and the problems I was having. It is strange that he knowing what had happened did not make any effort to preserve the records. Needless to say my life has been ruined and that of my husband's, since he has to be with me constantly. I have proof that my heart was of normal size and taken a year earlier was normal. I know of several other people who had the same type of vaccination at that time and suffered heart damage, also. I plan on taking this up with the attorney general, as  no attorney will help me so far. There is a much more detailed story but I would like to know the ingredients in that vaccine to protect my sons and grandsons. When I phoned the gvmt. concerning this matter I was sent this paper to fill out so I hope some one can help me. I have since heard that an allergy pt should not be given the two shots together.			Y	Y	Y		Y	Y	U	10/09/1997	10/10/1997	1		PVT	OTH	Tamoxifen					1						2	Cardiac arrest; Cardiac failure; Cardiomyopathy; Malaise; Respiratory arrest; Malaise; Myocardial infarction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0189815	09/06/2002					M	06/17/2002	It was reported that a male patient, with a complex medical history that included a partial gastrectomy, received Fluzone UNSP 1998-1999 sometime in November of 1998. Within 7 days of receiving the vaccine the patient experienced a pancytopenia and was hospitalized for 6 weeks. The patient's blood counts were described as recovering. Follow up 6/17/02:  during internal review of all files, it was deemed necessary to report as a 15 day alert report. Also added to pre-existing physician diagnosed allergies, birth defects, medical conditions (specify), complex medical history including partial gastrectomy.					Y				N	11/01/1998	11/08/1998	7		UNK	UNK			Complex medical history including partial gastrectomy		U199900028	1						1	Pancytopenia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0190085	09/13/2002	SD	7.0			M	09/05/2002	Worsening of nephrotic syndrome secondary to influenza vaccine. Pt has a history of nephrotic syndrome,most commonly associated with infections. Pt presented to hospital with weight gain, dropping albumin and fluid retention. Pt reported receiving an influenza vaccine at a remote clinic several weeks prior to admission.					Y				U		01/06/2002		Worsening of nephrotic sndrome secondary to influenza vaccine. Pt has a history of nephrotic syndrome, most commonly associated with infections. Pt presented to hospital with weight gain, dropping albumin and fluid retention. Pt reported re	UNK	UNK						1						1	Blood albumin decreased; Condition aggravated; Fluid retention; Weight increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0190270	09/18/2002		68.0	68		F		Report from pt's husband. Pt experienced joint pains (knees, ankles, and elbows) after receiving Fluvirin (for the first time). Pains reported as often quite severe. Pt's husband also experienced adverse event after receiving Fluvirin. Case linked to MPU2000-00086. Follow up above case received from a practice nurse. Pt (female 69 years old, height: 155cm, weight: 62Kg) experienced pains in ankles, knees, shoulders, and wrists (onset three to four weeks), cold sore inside nose and clicking of all joints after receiving (intramuscular dose) of Fluvirin. Pains unresolved. Outcome of other AE's unknown. Medication to treat AE: paracetamol and Ibruprofen spray. X-ray taken of knees and ankles. Medical history of painful spondylosis reported to be ongoing. Pt has not received previous vaccinations for flu. Further info received from the pt's husband stated that the pt continues to suffer acutely with pains in her ankles. She has consulted a rheeumatologist, who prescribed physiotherapy and a course of drugs (details not provided), and considered that the symptoms were consistent with a reaction to the vaccine. The reporter stated that the pain has reduced but has not gone completely, and that catching a cold still brings on the same symptoms. A follow-up report from a health professional was received on 8/19/02. The 69 year old female pt experienced pains in ankles, knees, shoulders, and wrists, clicking joints and had a cold sore in the nose, which was considered to be incapacitating three to four weeks after receiving a Fluvirin vaccine on 10/19/99. The pt received betnovate cream concomitantly. The pt had a medical history of spondylosis. The pt was diagnosed with osteoarthritic change in both knee joints on 2/8/00. The pt had not been given a flu-vaccination before. Pt also treated with oral ibuprofen since November 1999. At the time of reporting it was unknown if the pt had recovered. The reporter has assessed the relation of study medication to the event as probable.								Y	U	10/19/1999	11/01/1999	13		OTH	OTH	Betnovate cream		Spondylosis - ongoing		MPU200000089	1						1	Arthralgia; Herpes simplex	FLU3~EVANS VACCINES~N07~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0179132	09/19/2002	ID	42.0	43		F	12/10/2001	12/10/01 09:30 Flu vaccine given IM LD. 10:15 T.C. complained of numbness left arm, lips, no reaction at injection. Refer to PCP if condition worsens. 10:45 T.C. numbness to right hand--recommended Benaphen Liquid 4 tsp. Referred to P.C.P. 14:00 Did not visit P.C.P.--condition did not worsen. She will contact us if further concerns.									Y	12/10/2001	12/10/2001	0		PUB	PVT		None	None		ID01082	1						2	Hypoaesthesia	FLU3~PFIZER\WYETH~4018029~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0190347	09/19/2002		60.0	60		M		Non medically substantiated report received from a male pt, who experienced pains in joints (knees, ankles and elbows) after receiving Fluvirin. Pain reported as often being quite severe. Pt's wife also experienced an adverse event after receiving Fluvirin. This case is linked to MPU-2000-00089. No further details reported. Follow up report received from doctor. Male pt (DCT, 60 years old, 77Kg, 175cm) experienced pain in joints-ankles, wrists, knees, shoulders (onset 3-4 weeks), cold sores inside nose and clicking of all joints after receiving single dose of Fluvirin IM. No previous flu vaccinations. Pain in joints not resolved. Outcome of other AE's unknown. AE reported to be incapacitating. No cattarrh-no cold/flu symptoms as reported. Medical history insignificant. No concomitant medication. Causal relationship as per reporter is probable. Further follow up received from pt. Pt reports that the pains he has been experiencing have eased considerably, though some tenderness is still present in the ankles. A follow-up report from a health professional was received on 8/19/02. The 60 year old male pt experienced pain in ankles, knees, wrists, and shoulders, clicking joints and had cold sores inside the nose, which was considered to be incapacitating, approximately three to four weeks after receiving a Fluvirin vaccine on 10/19/99. The pt did not experience cold or flu symptoms. At the time of reporting the pt had yet recovered. The reporter has assessed the relation of study medication to the event as probable.								Y	U	10/19/1999	11/01/1999	13		OTH	OTH	NONE				MPU200000086	1						1	Arthralgia; Herpes simplex; Tenderness	FLU3~EVANS VACCINES~~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0190353	09/19/2002	MI	31.0	31		F	09/18/2002	Allergic rash, hives. Began at injection site. Also on torso, neck and arms.										09/17/2002	09/17/2002	0	Tubersol	PVT	PVT	None	None	None			1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~U0927AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0190357	09/19/2002	MA	7.0	7		F	01/15/2002	3cm localized reaction with redness and swelling. No cellulitis, minimal tenderness.									Y	11/15/2001	11/16/2001	1	None	PVT	UNK	Albuterol PRN	None	Asthma, NKDA			1						1	Erythema; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U0676AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0190360	09/19/2002	WA	58.0	58		F	11/28/2001	Local reaction 5cm diameter									Y	11/26/2001	11/27/2001	1	NONE	PVT	PVT	Premarin- well batrin	NONE	Sulfa, Codiene		WA011806	1						1	Injection site reaction	FLU3~SANOFI PASTEUR~U0593AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0190361	09/19/2002	WA	78.0	78		F	11/18/2001	The pot had pain and swelling at the injection site the day after the injection. She went to ER and arrived  on Rx for generic Keflex and get some Benadryl.				Y					Y	11/01/2001	11/11/2001	10		OTH	PUB		NONE			WA011804	1						1	Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~UO681AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0190366	09/19/2002	WA	53.0	53		F	10/29/2001	Hives, swelling, redness, and tenderness around site. Tx ice, Benadryl. 11/09/2001 called PCP office for further information- chart does not indicate hives- only 10 cm patch of redness, swelling , and tenderness. Left humeral area.				Y					U	10/26/2001	10/26/2001	0		PVT	UNK		NONE	Sulfa, Telenus, Sonsihur		WA011785	1						1	Injection site erythema; Injection site oedema; Tenderness; Urticaria	FLU3~SANOFI PASTEUR~40688AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1050L~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0190367	09/19/2002	ID	42.0	42		F	12/13/2001	Symptoms: myalgia, nausea, muscle swelling, rash. Treatment: Benadryl									U	11/13/2001	11/14/2001	1	Chemisty Panel, CBC, UA	PVT	PVT	Altace, Inderal, Zyrtec	None	Unk		ID01085	1						1	Myalgia; Nausea; Rash; Swelling	FLU3~SANOFI PASTEUR~U0673DA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0190368	09/19/2002	ID	37.0	37		F	12/06/2001	On 12/06/2001 Felt disoriented immediately after vaccine (1000). Felt nauseated (1100). Felt sleepy (1230) took a 2 hour nap. Slight fever ( 1400)- advised to take ibuprofen.									Y	12/06/2001	12/06/2001	0	NONE	PUB	PUB	Alupent Unasym	NONE	Allergies: animal dander, dust, smoke, grass		DD01083	1						1	Disorientation; Fatigue; Nausea; Pyrexia	FLU3~PFIZER\WYETH~4018054~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0190369	09/19/2002	GA	63.0	63		M	12/12/2001	Pt c/o redness and swelling to right arm with itching, States it is better than yesterday, Did have some fever and chills last night, No SOB, 12/14/01 Right arm swelling decrease also went to work, No more fever chills, Feeling better per his friend.									Y	12/11/2001	12/11/2001	0	NONE	PUB	PUB	NONE	NONE	NKA		GA01117	1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Pruritus; Pyrexia	FLU3~PFIZER\WYETH~4018040~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0996L~2~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0190370	09/19/2002	GA	22.0	22		M	12/07/2001	Immunization given on 12/5 at 5 PM. Friday morning 12/7 noticed face and ears swollen, red, and itching, also both arms. No actual rash. No difficulty breathing or swallowing. Advised to go to ER or urgent care but patient decided not to go.				Y					Y	12/05/2001	12/07/2001	2	None	PUB	PVT		None	None		GA01114	1						1	Erythema; Face oedema; Pruritus; Swelling; Swelling face	FLU3~PFIZER\WYETH~4018029~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0190371	09/19/2002	GA	21.0	21		M	11/21/2001	Four hours after vaccine client felt flushed, sweating, itching, hives on upper torso. SOB (hyperventilating) HR 126. 911 called. IV started 02 Meds?- SOB resolved with reassurance. Transported to hospital ER. Was hospitalized. Returned to work in 2 days with no after affect.				Y					Y	11/14/2001	11/14/2001	0	UNK	OTH	PUB		NONE	NONE		GA01113	1						1	Dyspnoea; Flushing; Hyperhidrosis; Pruritus; Urticaria	FLU3~EVANS VACCINES~E02781HA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0190570	09/24/2002					M	04/01/2002	A pharmacist reported that a male patient received an injection of influenza virus vaccine (manufacturer unknown) ten years ago. Approximately 24 hours post vaccination, the patient developed swollen lips, a rash and hives. He was seen by  a physician. No furter information was available at the date of this report.				Y					U				UNK	OTH	OTH	UNK	UNK	NKA		HQ1462425MAR2002	1						1	Face oedema; Rash; Urticaria	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0190586	09/25/2002	NJ	52.0	52		F	09/20/2002	It was reported by a female nurse that she received a dose of Fluzone (Trivalent types A & B). The last week of October 2000 for the first time, she has developed a very severe skin condition called Bullous Pemphigoid and Linear IgA disease, which is an autoimmune disease. Currently, both of her hands and feet started to have more lesions. She has been dermatologists and also went to a hospital as well. Biopsy was taken to confirm Bullous Pemphigoid and Linear IgA disease. Follow up # 1. From the pt indicated that she has been visiting her dermotologist every 4-6 weeks in th past 2 years. the rash, which started  around Oct 17 (no year specified) on her face, is still present and spreading. She is experiencing severe itching, is extremely uncomfortable and has redness, swelling, and excessive tearing in her eyes. The lesion on both of her hands which started in 18 dec 2002, has not resolved. the center of her palms are raw, itch, and tight (contracture). She also reported that her whole body is now scar from the rash and lesions that started since Nov 2000. The Fluzone was administered IM n the left deltoid. The pt considered her skin condition resulted in permanent disability due to unable to perform duty. The follow up received on 2/27/03 from the pt reporting that since she is a nurse herself, and due to her ongoing condition since the vaccination, that she is on restrictive duty at work and to see no patients. She also reports that she has been taking many creams and ointments-prednisone, to ease her condition. Both of her hands are still affected and have gotten worse, they are oozing and itching. She has seen at least 3 dermatologists and she states that all of the doctors agree that she has autoimmune disease. Her biopsy results showed linear IgA and possible famkphogoid; pt has had to use all of her vacation time and her scheduled time off because of this condition.				Y				Y	N	10/01/2000	11/01/2000	31	Biopsy was taken to confirm Bullous Pemphigoid and Linear IgA	PUB	OTH	Premarin, Vicodin ES		Allergic to sulfa and bee stings; chronic back pain.		U200200737	1						1	Discomfort; Immune system disorder; Lacrimation increased; Oedema; Pemphigoid; Pruritus; Skin disorder	FLU3~SANOFI PASTEUR~~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0190744	09/30/2002	FL	28.0	28		M	09/20/2002	45 minutes after immunization, patient experienced right eyelid swelling and wheezing, requiring emergency anaphalaxis treatment.				Y					Y	09/19/2002	09/19/2002	0	None	MIL	MIL	None	None	None			1						1	Eyelid oedema; Wheezing	FLU3~SANOFI PASTEUR~U0880AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|YF~SANOFI PASTEUR~UB232AA~1~SC~RA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0190837	10/01/2002	MN	20.0	18		F	09/06/2002	Headache, dizziness, blurred vision, paralysis, weakness, fatigue, seizures, joint pain, lower back pain, pulling in neck, and spinal cord, weight loss, fever, tremors, Has seen multiple specialist over the last 2 years.				Y				Y	N	09/21/2000	10/15/2000	24	Ct scans, MRIS, Spinal taps, Extensive blood work, toxicity tests, X-ray, visual evoked potential tests.	OTH	OTH	Orthotricyclen	NONE	NONE			1						1	Asthenia; Back pain; Convulsion; Dizziness; Fatigue; Headache; Neck pain; Paralysis; Pyrexia; Tremor; Vision blurred; Weight decreased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0190845	10/01/2002	CA	62.0	62		M	10/28/2002	Flu shot at 11am; at 11:20am began to itch and broke out in a rash in various areas. (Like poison ivy or oison oak). Staff examined rash at their cost. No treatment except home remedies-baking soda etc. Six weeks to clear. Photo tells it all! Rash over 30% of my body-arms, legs, lower torso, belt line, buttocks and other private areas.									Y	11/22/1991	11/22/1991	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0190932	10/02/2002	SC	1.6	1	.6	M	09/30/2002	Severe hives, dizziness and little bit of weakness.									N	09/26/2002	09/26/2002	0		UNK	UNK						1						1	Asthenia; Dizziness; Urticaria	FLU3~SANOFI PASTEUR~U0877AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0190983	10/02/2002	IN	31.0	31		F	10/02/2002	Patient c/o chest tightness, dizziness and nausea approx. 20 minutes after receiving flu vaccine. Symptoms resolved 20 minutes later w/o treatment.									Y	10/01/2002	10/01/2002	0	Physical exam was unremarkable. Lungs were clear to auscultation, peak flows were normal.	PVT	UNK	Allegra180 mg, Nasaccort AQ,Patanol, Elidel cream, Albuterol MDI,	none	Eczema, Asthma,			1						1	Chest discomfort; Dizziness; Nausea	FLU3~SANOFI PASTEUR~U0882AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191030	10/07/2002	SC	23.0			M	09/30/2002	09/03/02 - Vestibulitits, encephalitis, ataxia, urinary retention. It is the opinion of the physician that these symptoms being a result of the immunization is questionable.					Y	10			Y		09/03/2002		PPD	MIL	UNK	PPD					1						1	Coordination abnormal; Encephalitis; Urinary retention; Vestibular disorder	FLU3~SANOFI PASTEUR~UO88088~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~T10982~UNK~~~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Hospitalisation	Influenza
0191031	10/07/2002	FL	75.0	74		F		Affected muscle in my neck across shoulders back, swollen right ankle. Treated for rheumatoid arthritis said to have been brought on by vaccine. had broken right arm-affected left arm where shot was given the year before. Couldn't get clothes on or off. MD gave me Sulen Dx which helped soreness swelling but I dropped everything couldn't sleep-coughed and coughed all night I had horrible headaches. Couldn't take Aspirin. My pharmacist said to get off it for 2 weeks and then take Aspirin. I had fallen three times bending my left wrist back twice and I twisted my right ankle. The third time I went down on my back and shoulders and neck. My left arm (the inside) was solid black and blue. The regular doctor had me on Celebrex and Prednisone she then sent me to a rheumatoid arthritis doctor 2/26-3/26. Last Sept 2001 I helped my neighbor take up his old deck I lifted 39 6ft x 4in deck boards. I am an outside working person. Thanks to the prednisone I went from 126lb to 113lb. All muscles. As one doctor put it about a year before, I've never seen some your age with so much muscle now I have hanging skin and ouch ouch ouch-can't and aged 10-15 years. I was walking two miles a day plus what I did around the house mowing the yard etc. They can put a man on the moon but you can't have a solution to contract the flu shot. Please help. Next day pain from right arm across shoulder to left arm Celebrex Sulindac fell fractured wrist 3/21/02, 3/23/02 fell on 3/21/03 fell fractured ribs, ankle, elbow and back. Prednisone back muscle 13of 113 rbs Oct 2002. Bextra had rash, 3/21/03 fell fractured ribs.								Y	N	11/12/2001	11/13/2001	1		OTH	OTH	Thyroid (Levoxyl)	NONE				1						1	Cough; Fall; Headache; Hypokinesia; Injury; Oedema; Rheumatoid arthritis	FLUX~UNKNOWN MANUFACTURER~90659~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0191082	10/08/2002	KS	1.75	1	.8	F	10/03/2002	30 minutes after flu vaccine (Aventis) 0.25 injected, child developed spreading, red, fine rash to chest and torso. VS 144 pulse 36-> Benadryl 12.5 mg IM, 15 mins after injection pulse 136 .									Y	10/03/2002	10/03/2002	0	NONE	PVT	OTH	NONE	NONE	NKA			1						1	Rash erythematous	FLU3~SANOFI PASTEUR~UO874AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191084	10/08/2002	CA		30		F		Severe pain, tighening, cramps, spasms in upper and lower back. Pain began 24 hours after shot (flu).				Y					N	10/22/2001	10/23/2001	1	PPD	PUB	UNK	Ditropan, Skeelaxin, Tylenol with Codeine, Bacophen		None			1						1	Chest discomfort; Muscle spasms; Pain	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0191085	10/08/2002	AK	7.0	7		F	09/23/2002	Developed chickenpox rash after varicella vaccine									Y	09/18/2002	09/20/2002	2	NONE	PVT	PUB	Advair, Singular, Nasonex, Albuterol	NONE	Asthma			1						1	Dermatitis bullous	FLU3~SANOFI PASTEUR~UO885AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0039M~1~~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0191089	10/08/2002	AK	30.0	30		F	09/30/2002	Pt describes becoming pale, shaky,nauseated like I had the flu. Pt stated she felt the flu vaccine caused her blood sugar to drop and for her to have.  Follow up: had dizziness, body ache and pain in right arm.  Prescription for Phenergan.  Seen at work next day, feeling better.				Y					Y	09/27/2002	09/27/2002	0	blood sugar < 120	PUB	PUB	Oral Hypoglycemic	type II Diabetes	Type II Diabetes	weak arm pain~Influenza (Seasonal) (no brand name)~~29.00~In Patient		1						1	Blood glucose decreased; Influenza like illness; Nausea; Pallor; Tremor	FLU3~SANOFI PASTEUR~UO885AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191094	10/08/2002	CA	41.0	41		F	10/03/2002	Patient describes that she became ill the day after receiving the vaccination. Nausea, weakness, shakiness, hurt all over and she got a severe migraine. These symptoms lasted 2 days. Also she had chills and questionable fever on 10/01/02.									Y	09/30/2002	10/01/2002	1	None	PVT	PVT	Celexa	None	Allergy, PCN, Hx of Migraine headaches.			1						1	Asthenia; Migraine; Nausea; Pain; Tremor	FLU3~EVANS VACCINES~E34112HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0191156	10/09/2002	WA	39.0	39		F	10/06/2002	I got sick in the year 2000, I believe as a result of the flu shot. I remained severely ill from the end of the year 2000, through to the month of October 2001. At that time, the severity of the symptoms began to subside a little bit therefore I thought  that I was on the road to recovery. Then in November, for and through work, I got another flu shot. Consequently the severity of symptoms has increased, and health has been a significant struggle. This include severe muscle and joint pain, headaches, burning pain in the spine, centered around the base of the skull, persistant right sided weakness, especially in the arm and leg, right side of face is drooped and lacks muscle tone and strength of the left side. Right eyelid is also droopy. I am only able to work part time instead of full time, due to persistent pain and fatigue.								Y	N	11/28/2000	12/12/2000	14	Cat scan of brain twice; MRI of brain twice; Multiple blood tests and X-rays	OTH	OTH	Wellbutrin, Tylenol, Pains meds for use PRN	Still somewhat  symptomatic from previous vaccinations. Did not realize this was  what was making me sick.	NKA, Hx: Crohn's disease - in remission, Symptomatic from previous vaccinations. Doctor thinks fibromylgia	return of sumptoms from previous~Influenza (Seasonal) (FluShield)~~39.00~In Patient		1						1	Arthralgia; Eye disorder; Headache; Hemiparesis; Hypotonia; Myalgia	FLU3~PFIZER\WYETH~4008124~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0191172	10/09/2002	NC	52.0	52		F	10/08/2002	L arm injection-within 2 hrs 4cm swelling, dark, painful, not hot.									Y	09/25/2002	09/25/2002	0		PVT	UNK	Prednisone 20mg, Actoned	NONE	Thrombophelitis, s/p PE, sarcoldoms, allergic seafood			1						1	Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U0925AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~1159L~UNK~~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0191173	10/09/2002	NC	65.0	65		F	10/08/2002	Wed-3 hrs after shot started getting tired. Thurs-felt flu like sx. Fri-dizzy in the am, ate chick salad for lunch; then threw up-called office and was told to eat dry food. Felt like arthritic pain in hip. Site reaction-red spots.									Y	10/02/2002	10/02/2002	0		PVT	UNK		NONE	HTN, DM, DA, seasonal allergies, anemia of CD, FBD			1						1	Arthritis; Dizziness; Fatigue; Influenza like illness; Injection site erythema; Pain; Vomiting	FLU3~SANOFI PASTEUR~0U925AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~1159L~1~SC~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0191211	10/09/2002	KS	55.0	55		F	10/09/2002	Injection site is inflamed with localized edema and itching.  Some tightness and slight pain, increases with movement.  Area had redness and feels hot to touch.  Cont. x 5 days.									Y	10/02/2002	10/02/2002	0		MIL	MIL		None	None			1						1	Erythema; Feeling hot; Injection site inflammation; Oedema; Pain; Pruritus	FLU3~SANOFI PASTEUR~U0880AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191213	10/09/2002	OH	41.0	41		F	10/09/2002	Began itching within 1 1/2 hours after vaccine.  Started noticing warm blotchy skin 2 hrs. after vaccine.  Notified nurse administering vaccine approximately 4 hours after vaccine.  Was sent to Emergency Room for treatment at that time.  Required 3 injections.  One of cortizone and 2 of Benedryl.  Was prescribed to take Benedryl every 4 - 6 hours hours until signs and symptoms are gone.				Y					Y	10/08/2002	10/08/2002	0		UNK	PVT	Currently taking Bextra and Duratuss.		Cipro			1						1	Feeling hot; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0191196	10/10/2002	OK	61.0	61		M	10/01/2002	Edema, redness & pain to right upper extremity, Injection site & surrounding area.				Y					U	09/26/2002	09/27/2002	1		OTH	OTH	Guaifenesin, Gatifloxacin, Paroxetine, Ipratropium, Fosinopril, Potassium. Doxazosin, Docusate Sodium, Amitriptyline, Theophylline, Furosemide, Calcium Carb, Montelukast, Rabeprazole	URI, COPd Exacerbation	Allergy-Demerol, Dx is COPd, HTN, Bipolar disorder &CAD			1						1	Injection site erythema; Injection site oedema; Injection site pain	CHOL~LEDERLE LABORATORIES~0111M~1~IM~LA~CHOLERA (USP)~1|FLU3~SANOFI PASTEUR~UO877AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191199	10/10/2002	MI	24.0	23		M	10/04/2002	Itching-Benadryl 25mg IVP.  Follow up: Generalized itching.  Patient since had itching post dialysis; center has recently changed suppliers of sulution fused in dialysis.									Y	10/04/2002	10/04/2002	0	NONE	PVT	OTH	NONE	ESRD	Fortaz Beta Loctramine			1						1	Pruritus	FLU3~SANOFI PASTEUR~U0877AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191200	10/10/2002	AR	4.0	3		F	10/04/2002	10cm x 12cm area with 10 small blisters in a 2x2cm area in middle of area. Area red, swollen, warm to touch.  Follow up: Right thigh site.  Prescribed antibiotics.									Y	09/30/2002	10/02/2002	2		PVT	PUB		NONE				1						1	Injection site erythema; Injection site oedema; Injection site vesicles; Injection site warmth	DTAP~SMITHKLINE BEECHAM~572A2~5~~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U0878AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~U1645~4~~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0737L~2~~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0191214	10/10/2002	FL	74.0	74		F	10/10/2002	Patient states had tremors, violent shaking, nausea and vomiting for 6 hours after vaccination				Y					Y	10/07/2002	10/07/2002	0	Denies prior problems	PUB	PUB		denies				1						1	Nausea; Tremor; Vomiting	FLU3~SANOFI PASTEUR~uo913aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191215	10/10/2002	NJ	37.0	37		M	10/10/2002	Sore throat									Y	10/08/2002			n/a	PVT	UNK		none	none			1						1	Pharyngolaryngeal pain	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0191255	10/10/2002	MO	69.0	68		F	10/10/2002	Within three days of administration of influenza vaccine, patient developed worsening muscle weakness especially of axial muscles.  This peaked at about two weeks post administration and is improving.  There were no other symptoms or muscle pain or tenderness.  This was significant enough that she could not climb stairs at its peak.  Concern is of possible mild Guillain-Barre (pt declined LP) Per 60 day follow up: Recovery is still unknown, weakness is improved so so but persists, and has been determined to have shot given which may contribute. The medical record states GBS, demyelinating polyneuropathy.				Y					U	09/19/2002	09/22/2002	3	CBC, TSH, liver enzymes, CK, and ESR all normal	UNK	UNK	propranolol, evista, prilosec, Premarin cream, calcium, vitamin E Aspirin, MSM, Citracal,	No	History of breast cancer, colon cancer, osteoporosis, GERD, Glaucoma,			1						1	Guillain-Barre syndrome; Neuropathy	FLU3~EVANS VACCINES~E30152GA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0191228	10/11/2002	AR	2.0	2	.5	M	10/09/2002	At 18 hrs after dose, swellen hands and feet. Generlized urticarial lesions. No bruises. Follow up: allergies type whelps-red.  Prescribed Benadryl/coolpacks.  REsolving									U	10/08/2002	10/09/2002	1	NONE	PVT	PVT	Singular qd  Acyclovir qd	NONE	Herpetic stomotitis of scalp-RAD			1						1	Oedema peripheral; Urticaria vesiculosa	FLU3~SANOFI PASTEUR~U0910AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191229	10/11/2002	GA	49.0	49		F	10/28/2002	Conjunctivitis per eye. MD instructed her to report it. 5 x after flu shot given. C/O achiness, body leg aches, back aches- stated she is better from all that now.  It only lasted a couple of days. Her eyes still slightly red. To go to MD if not better by tomorrow.									Y	10/03/2002	10/04/2002	1	NONE	PUB	PUB	NONE	NONE	Diabetes typ II (Diet controlled)			1						1	Conjunctivitis; Eye disorder; Ocular hyperaemia; Pain	FLU3~EVANS VACCINES~E31972GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0191230	10/11/2002	MA	45.0	45		F	10/16/2002	Developed hives all over the body within 1/2 hr of shot. no other symptoms.									Y	10/08/2002	10/08/2002	0		UNK	UNK	Synthroid, Duantin	NONE	Hypothyroidism, Seizure disorder			1						1	Urticaria	FLU3~SANOFI PASTEUR~UO9698A~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191231	10/11/2002	OH	83.0	83		F	10/04/2002	Red rash right middle arm. 10 x 12 cm diameter . no warmth minimal edema. Allegra 1 day sample										10/02/2002	10/03/2002	1		PVT	PVT	Several test of # 14; Vasotec, cueg, lanolin, lasix, coumadin, micro-k, thazadone, ambien, valium, prolosec, evista, colestid, coreg, qualsium, vite	NONE	Tonocard, CAD, increase cholestral, glaucoma, osteoporosis, atrialfib, history of CVAs			1						1	Rash	FLU3~SANOFI PASTEUR~U0910AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0541M~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0191232	10/11/2002	MD	21.0	21		M	10/05/2002	Immediately following vaccine patient became pale and diaphoretic lost consciousness apprx. 20-30 seconds. Patient was helped to floor placed on 100% NRB mask for 15 mins. Given p o fluids and recovered. No signs of allergic reaction noted. Injection site was benign. Patient returned to duty within 1 hr of event. Vital signs stable and after event.									Y	10/05/2002	10/05/2002	0	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Hyperhidrosis; Loss of consciousness; Skin discolouration	FLU3~SANOFI PASTEUR~U0880AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191261	10/14/2002	NY	51.0	51		M	01/02/2003	Flu shot. 10-11 days later GBS. Hospitalized for 3 months. Total paralysis-only could move eyes many complications since.			Y	Y	Y	90			U	11/08/2001	11/17/2001	9	NONE	OTH	UNK		NONE	NONE			1						1	Guillain-Barre syndrome; Paralysis	FLU3~EVANS VACCINES~EV83410N~1~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0191266	10/14/2002	NE	53.0	53		F	10/04/2002	After receiving flu shot, arm got red, inflamed, hot to touch. Size measured 3.5x2.5. n Follow up: prescribed: antibiotic, decongestant.									Y	10/02/2002	10/02/2002	0	PPD	PVT	PVT	Prinivil, Premarin, Duazise, Prilosec	None				1						1	Erythema; Feeling hot; Injection site inflammation	FLU3~SANOFI PASTEUR~U0903AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191328	10/14/2002	NJ	1.9	1	.9	M	10/14/2002	Started out with Chills as 7 PM, then she had a fever of about 101 degrees.  This lastest for 4 days.  The fever ranged from 101-104.  She had 104.5 on Wednesday night.  The doctor said this was probably a virus and had nothing to do with the flu shot because he's never seen anyone have a reaction to a flu shot.  There were no other signs of a virus though, i.e. no running nose or cough.  Then on Saturday 10/12, pt had a full body rash, spots all over her.  The spots have subsided by Monday.  Pt was taken to another doctor on Friday and she agreed it was most likely caused by the flu shot.  Pt only received half of the flu shot.				Y					Y	10/08/2002	10/08/2002	0		PVT	UNK	Pulicort through a nebulizer					1						1	Chills; Pyrexia; Rash	FLU3~PFIZER\WYETH~4020012~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0191317	10/15/2002	AZ	76.0	76		F		Ached very very badly. Skin hurt. Shortness of breath and very weak. No physician evaluation recorded with fluids received; heating pad for 5 days.								Y	Y	10/10/2002	10/10/2002	0		UNK	UNK	FLovent; Albuterol sulfate; Theophylin;	Only chronic conditions	Asthmatic emphysema; osteoporosis			1						1	Asthenia; Dyspnoea; Pain	FLU3~SANOFI PASTEUR~U091BA~7+~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0191329	10/15/2002	NY	41.0	41		M	10/15/2002	Within 16 hrs of receiving Flu shot severe muscle ache began and has lasted 6 Days. Within 28 hours High Fever estimated in excess of 102 degrees (Estimate due to hallucinogenic period) accompanied by severe headache, cold sweat, sleeplessness, frequent urination and thirst, duration approx 48 hours. Treatment was unavailable due to out of country on vacation, remained bedridden two days barely able to move due to muscle and joint pain. Doctor scene immediately upon return to military base however, symptoms were dramatically improved by this point. (*) Hospitalization is estimated at two days if one was available. (*) Would have been life threatening if my health wasn't as good as it is. (* Personal Opinion).  Still suffering from muscle and joint pain which improves with continues movement throughout the day. Doctor suggested reporting via this form.			Y	Y	Y	2			Y	10/10/2002	10/11/2002	1		MIL	MIL	N/A	none	None			1						1	Headache; Hyperhidrosis; Insomnia; Myalgia; Pollakiuria; Pyrexia; Thirst	FLU3~PARKDALE PHARMACEUTICALS~U0983AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|TD~UNKNOWN MANUFACTURER~U0526AA~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0191340	10/16/2002		50.0			F		A report was received on 10/2/02, concerning a 50 year old female pt who experienced capsulitis of the shoulder and a small sensitive lump in the armpit after receiving Fluvirin vaccine in November 2001. On an unknown date, the pt initially complained that the right arm at injection site was tender several weeks after receiving Fluvirin in November 001. On an unknown date, a small sensitive lump developed in the right armpit. More recently, the pt complained of restricted movement in the right arm and in September 2002 approximately the pt was diagnosed with capsulitis of the shoulder. At the time of reporting the pt had not recovered and was receiving physiotherapy. There was insufficient info to determine the reporter's causality assessment. Follow up on 02/12/2003: Follow up report was received from a health care professional, concerning a 52 year old vaccinee which stated that the vaccines had no history of trauma.  Within 24 hours of receiving the vaccination there was pain at the site of the injection and the vaccinee had an inability to throw objects.  There were small painful lumps in the right armpit.  Over 10 months there was increasing severity of pain, which the reporter considered to be temporarily disabling.  The pain increased particularly when the muscle was jarred and used as in, for example, attempting to throw or in chopping actions.  There was periodic throbbing pain, which was apparently spontaneous.  The vaccinee experienced sleep disturbance due to pressure on the upper arm when lying on the right side.  There was increasing, though not very severe, loss of power in the arm.  there were increasing difficulties over 10 months with the shoulder, although the reporter was unsure if this was directly related as the vaccinee had had a history of difficulties with the other shoulder.  Examination of the vaccinee on 09/16/2002, showed there was limitation of abduction of the right shoulder to 70 and some limitation of external rotation, other movements were normal.  The health care professional felt that this indicated a degree of capsulitis resulting from a chronic painful shoulder which had stiffened up because it was not being used due to pain.  It was presumed the injection was the cause of that pain, which may have become self-perpetuating as the shoulder stiffened up.  The health care professional did not feel that the vaccine would have had a direct toxic effect on the joint capsule, as the injection would have been administered in the muscle some distance from the capsule.  On 12/01/2002, the vaccinee was still unable to throw, although the pain had lessened.  There was a small indentation in the upper arm at the injection site and the vaccinee experienced sensitivity in this immediate area.  The shoulder pain and range of movement had improved due to targeted exercise.  On 01/22/2003 the vaccinee's condition had improved greatly, and her recovered almost 90% of the range of movement.  The vaccinee was still unable to throw objects without pain, but this pain was less.  There was no loss of power to the arm.  The vaccinee received a tetanus booster (brand unspecified) in 2001 and 2 hepatitis B vaccinations, one in December 2001 and the other in May 2002.								Y	U	11/01/2001	09/01/2002	304		UNK	UNK					PJP200200470	1						1	Bursitis; Injection site pain; Neoplasm	FLUX~UNKNOWN MANUFACTURER~760845~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0191349	10/16/2002	CA	41.0	41		F	10/06/2002	My arm was sore for a long time, then got a sudden pain up left arm and shoulder, Difficult to move shoulder arm and neck, Shot on left arm				Y					Y	10/05/2002	10/05/2002	0	N/A	MIL	MIL	NONE	NONE	NKA			1						1	Injection site pain; Joint range of motion decreased	FLU3~SANOFI PASTEUR~U0880AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191350	10/16/2002	IL	48.0	48		F	10/08/2002	Fever, aches, not feeling well, Had not consulted physician for 3 day since shot. Recommended patient consult with physician.									U	10/05/2002	10/06/2002	1		OTH	PVT	NA	NONE	NKA			1						1	Malaise; Pain; Pyrexia	FLU3~SANOFI PASTEUR~UO872AB~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0165M~4~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0191351	10/16/2002	IL	3.5	3		F	10/10/2002	Pt was well before Fluzone injection was given. Within 1-2 hours, the pt developed urticaria. There were no other new exposures, allergens or any viral symptoms. The hives have continued for one day at this point. There was no mucous membrane involvement and no airway compromise.				Y					U	10/08/2002	10/08/2002	0	NONE	PVT	PVT	NONE	NONE	Ex-premature triplet infant born at 27 weeks. She has no lasting problems or deficits.			1						1	Urticaria	FLU3~SANOFI PASTEUR~U0886AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191352	10/16/2002	GA	54.0	54		F	10/11/2002	Pt's R arm became red, swollen, feverish. Pt had sx of N/D/V, HA. Adv. pt to use ice packs, force fluids, rotate Tylenol and Motrin q 4 h.									Y	10/04/2002	10/06/2002	2		PVT	OTH	O2, Albuterol, Iprotop		PCN, sulfa, COPD			1						1	Headache; Injection site erythema; Injection site oedema; Pyrexia	FLU3~EVANS VACCINES~E34692HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1352L~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0191353	10/16/2002	MS	67.0	67		F	10/08/2002	PHN was talking with pt ~ 5 mins post inj. of pneu. and flu. pt stated felt lightheaded pt face was flushed eased to chair. Nurse called for assistance from aide. Pt then grabbed lower R back area described pain as grabbing and releasing also stated chest felt heavy with slight SOB. BP 120/90 phoned local MD. Pt felt better pain eased, no further c/p or SOB. Pt taken to MD office per pt vehicle per nurse. Rec'd call from RN. EKG-wnl, pt was sent home in good condition. Phoned pt-states she is doing okay no further probs or sx-dx per MD-near syncopal episode.				Y					Y	10/08/2002	10/08/2002	0	EKG-wnl	PUB	PUB	Cenestin-hormone 1.25/d				MS02028	1						1	Back pain; Chest discomfort; Dizziness; Dyspnoea; Hot flush	FLU3~SANOFI PASTEUR~U0971AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0445M~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0191354	10/16/2002	LA	29.0	29		F	10/09/2002	On 10/9/02 employee came to my office with flu like symptoms since vaccine was given on 10/1/02. Achy, chest hurting, fatigue.									U	10/01/2002	10/01/2002	0	CBC on 10/9/02	UNK	UNK			Allergic to shell fish			1						1	Chest pain; Fatigue; Influenza like illness; Pain	FLU3~SANOFI PASTEUR~U0882AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191355	10/16/2002	WA	2.0	2	.0	F	10/14/2002	Progressive cutaneous warmth/swelling/redness initially 15cm circonference at 24 hrs post vaccine then expanding across chest/arms and  concern for cellulitis no fever. Treated with antibiotics (Keflex). Site is right deltoid.									Y	10/09/2002	10/09/2002	0		PVT	PUB	NONE		NONE			1						1	Cellulitis; Injection site erythema; Injection site oedema; Injection site warmth	DTAP~SANOFI PASTEUR~U0583BA~4~IM~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U0968AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~SMITHKLINE BEECHAM~253A2~1~IM~LA~HEP A (HAVRIX)~1	USA		Influenza
0191410	10/17/2002		82.0	82		F	09/18/2002	It was reported that an 82 year old female pt with a history of arthritis in shoulder was vaccinated with Fluzone SV '01-'02 in her left arm on 10/18/01 and Pnu-Imune on 10/24/01. On 10/25/01 the pt developed a swollen arm and was hospitalized with an infection of the left shoulder. Further info is requested. 9/16/02: During internal review of all files, it was deemed necessary to amend the report by upgrading this case to a 15 day alert report due to this case being SAE and unlabeled.					Y				U	10/18/2001	10/25/2001	7		UNK	UNK			Arthritis in shoulders		U200101181	1						1	Infection; Injection site oedema	FLU3~SANOFI PASTEUR~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0191420	10/17/2002	TX	18.0	18		F	10/08/2002	Within 15 minutes of receiving vaccine, patient became short of breath, was audibly wheezing. Benadryl 50mg PO; Pulmo-Aid treatment with albuterol. Tolerated well. SOB improved. No audible wheezing except to auscultation right upper lobe only.			Y						Y	10/08/2002	10/08/2002	0	None	UNK	UNK	Albuterol Inhaler		Asthma	~Influenza (Seasonal) (no brand name)~~11.00~In Sibling		1						1	Dyspnoea; Wheezing	FLU3~SANOFI PASTEUR~U0966AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0191422	10/17/2002	NJ	44.0	44		F	10/15/2002	Gave .5cc of flu vaccine left deltoid at 09:30. Asked patient to remain in medical 5-10 minutes. 09:35 Patient complained of being hot. Advised to remove outer sweater (had on turtleneck under sweater). 09:37 Color pale turned ashen, slumped in chair to right side, eyes rolled to back of head, started to seize, back ache. Jacksonian movements noted of arms and legs. Patient supported. Called across hall to maintenance. Call 911. Gently patted face calling name. Ceased breathing; Carotid pulse absent. Eased to floor. Color: deep red; in progress of starting CPR. Head back; airway patent. Patient woke up coherent. 09:55 About 3-4 minutes unresponsive. BP 124/80. A 48 reg. 911 responded and taken to hospital via ambulance.				Y	Y				Y	10/15/2002	10/15/2002	0		OTH	PVT	None	None	None			1						1	Apnoea; Back pain; Coma; Convulsion; Eye movement disorder; Feeling hot; Hyperhidrosis; Pallor; Pulse absent; Simple partial seizures; Syncope; Vasodilatation; Vomiting	FLU3~EVANS VACCINES~E304126A~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0191426	10/17/2002	TX	67.0	67		M	10/12/2002	Severe nasal discharge with sinus congestion, Abnormal dryness of eyes and skin on hands, Plus neck, hip and elbow ache, Placed 2 tsp Colostrum under tongue, This provided relief, Shot received about 12:30 pm, Symptoms began approx 8:15 pm									Y	10/10/2002	10/10/2002	0	NONE	MIL	MIL	NONE	NONE	NKA			1						1	Arthralgia; Dry eye; Dry skin; Neck pain; Rhinorrhoea; Sinus congestion	FLU3~PFIZER\WYETH~U0880AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0191427	10/17/2002	CA	53.0	53		F	10/11/2002	1/2 hour after administration of the influenza vaccine patient developed a maculopapular rash on the upper extremities, neck and upper chest, Benadryl 25 mg every six hours prn									Y	10/10/2002	10/10/2002	0	NONE	OTH	PVT	Claritin D,  Previcid, Premarin,Darvox	NONE	Allergic Rhinitis, Rheumatoid Arthritis, GERD			1						1	Rash maculo-papular	FLU3~PFIZER\WYETH~4020017~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0191429	10/17/2002	FL	77.0	76		F	10/17/2002	Had flu shot and 1st ever dose of Altace, Developed facial, oral and throat edema after about 45minutes. Denies fever, difficulty breathing or other problems, Started Benadryl on own, Notified my office 24 hours later reported swelling much improved and only c/o sore throat. Saw in office 10/2/02 with no residual swelling									Y	09/30/2002	09/30/2002	0	CBC with differential- at baseline except increased mono 14%	PVT	PVT	Imdur, Synthroid, Lasix, KCl, Calan, Klonopin, Sinemet, Nexium, Carafate, Reglan, Vicodin, Premarin		Allergy- Sulfa, TCN. PHH:HTN, Hypothyroidism, GERD, Parkinson's, HX: Cushing's			1						1	Face oedema; Pharyngeal oedema; Swelling face	FLU3~SANOFI PASTEUR~E34692HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191433	10/17/2002	MT	92.0	92		F	10/08/2002	Pt c/o itch at injection site; area red, swollen, feverish to touch. MD informed of reaction. Claritin 5mg po, ice pack to arm, pt observed for 40 min for reaction.									Y	10/08/2002	10/08/2002	0	NONE	PVT	PVT	Albuterol med, Imdur, Bioptic, Prevacid, Duragesic patch, Ambien, Lortab, Ditropan	C/O muscle pains	Allergic feldine, iodine, sulfa, erythromycine; COPD, ASCVC, osteoporosis, diverticulitis, cystitis, DJD			1						1	Injection site erythema; Injection site hypersensitivity; Injection site oedema; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~U0880AA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191435	10/17/2002	KY	49.0	49		F	10/09/2002	Received flu shot 10/04/02 & within 20 minutes arm & shoulder hurt, PM 10/05/02 -  arm & shoulder felt like it had a fever, Sunday PM 10/06/02 rash on back, AM 10/07/2002 pustules on trunk of body, legs, neck and in throat. Went to MD AM 10/07/02 & was put on Prednisone orally and cream, Zyrtec & Keflex, Lymph nodes right neck are swollen, blood work done.				Y					Y	10/04/2002	10/04/2002	0	CBC, Pt unsure of what other labs were done.	PUB	PUB	Lipitor ,Estrastap	NONE	Allergic to PCN, States contact lens solution (Thimeresol) caused eyes to swell, burn & get red.			1						1	Injection site pain; Injection site warmth; Lymphadenopathy; Myalgia; Rash pustular	FLU3~SANOFI PASTEUR~UO886AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191567	10/17/2002	OH	33.0	33		M	10/17/2002	VACCINE ADMINISTERED ON 10/14/02.  ON 10/15/02 THE PATIENT DEVELOPED FEVER, MALAISE AND CHILLS. LATE IN THE DAY, THE PATIENT DEVELOPED A VESICULAR RASH.  ON 10/16/02, A GENERALIZED VESICULAR RASH WAS NOTED.  ON 10/17/02, A RASH, MALAISE, AND CHILLS STILL PRESENT.				Y					U	10/14/2002	10/15/2002	1		PUB	PVT	NONE	NONE	NONE			1						1	Chills; Malaise; Pyrexia; Rash vesicular	FLU3~EVANS VACCINES~E34102HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0191523	10/18/2002	CT	75.0	75		F	10/16/2002	On 10/12/02 rash on abdomen. On 10/13/02 rash was covering her back , neck, buttocks, and both arms and stomach, not on legs. Raised sunburn in appearance. Itching. Diagnosis of acute allergic reaction to Pneumovax or flu vaccine. Headache. Difficulty breathing; treatment with Benadryl, Prednisone and Oxygen. Patient instructed never to receive flu vaccine in the future.					Y	3			Y	10/11/2002	10/12/2002	1		OTH	PVT	Azmacort; Clarinex; Uniphyl	None	Asthma; Allergies to trees and grasses; Amoxicillin; Bactrim			1						1	Headache; Hypersensitivity; Pruritus; Rash; Rash erythematous; Rash	FLU3~SANOFI PASTEUR~U0911BA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0445M~2~~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U0911BA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0191527	10/18/2002	FL	77.0			F	10/11/2002	Forty-five minutes after receiving influenza shot, spouse of client phoned stating wife complained of chills, had vomited x T and had fever of 102.8. Fever abated after dose of Tylenol.									Y	10/11/2002	10/11/2002	0	Urinalysis: negative	PUB	OTH	Diazide, Zestoril	NONE	HTN			1						1	Chills; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U0881AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191528	10/18/2002	CA	50.0	50		F	10/11/2002	Continues to have pain L deltoid after flu shot on 10/4/02 at 1600. On scale 1-10, rates pain as 4 today 10/11/02.									N	10/04/2002	10/04/2002	0		PVT	UNK	NONE	NONE	NONE			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U0968AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191529	10/18/2002	MD	7.0	7		M	10/15/2002	Fever to 104.8 (axil) x 24 hrs following vaccine. Temp normal by ~ 36 hrs.									Y	10/11/2002	10/11/2002	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Pyrexia	FLU3~SANOFI PASTEUR~U0971AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191530	10/18/2002	IL	48.0	48		F	10/10/2002	Muscle stiffness, redness surrounding vaccine site 3 1/2 x 5 sl raised.									Y	10/08/2002	10/09/2002	1		PVT	PVT	Claritin, Flovent	NONE	Allergic rhinitis, asthma			1						1	Injection site erythema; Injection site swelling; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U0924EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0461L~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0191531	10/18/2002	CT	52.0	52		F	10/16/2002	L arm red from deltoid to elbow on 10/16/02. Pain is reported for the L arm as well as a heavy feeling in the arm. Will see PMD for those complaints 10/16/02.				Y					U	10/14/2002				UNK	UNK		NONE	NONE			1						1	Injection site pain; Sensation of heaviness	FLUX~UNKNOWN MANUFACTURER~~7+~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0191532	10/18/2002	CA	67.0	67		F	10/15/2002	Arm swelled up on the pneumococcal side. Was able to go to work the next day but went home early because got sicker and sicker. Still don't feel well. Blood suger is up over 200, diabetic.									U	10/14/2002	10/14/2002	0		UNK	UNK	Insulin; Zestril		DM; HTN			1						1	Blood glucose increased; Injection site oedema; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0191533	10/18/2002	GA	55.0	55		F	10/17/2002	Shortness of breath, back pain, stayed up all night, headache. Still has headache and shortness of breath.									N	10/16/2002	10/16/2002	0		UNK	UNK						1						1	Back pain; Dyspnoea; Headache; Insomnia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0191544	10/18/2002	MD	21.0	20		F	10/10/2002	Headache, neck pain, chills, inc 103, body aches.									N	10/09/2002	10/09/2002	0		PUB	PUB	Synthroid	NONE	Pregnancy 13 weeks-advised to received vaccine			1						1	Chills; Headache; Neck pain; Pain; Pyrexia	FLU3~PFIZER\WYETH~4020025~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0191599	10/19/2002	WI	45.0	45		M	10/19/2002	Recieved Pnuemonia and influenza injections on Thurs 10/17 at 3pm. My upper arm was mildly sore but not red upon awakening friday AM. By friday 10 PM it was extremely sore, to the point brushing it lightly was painful- however area was not red, at about 11:30 pm I suddenly developed severe chills, to the point where I crawled in my -20 f northface sleeping bag, despite the room temp being 72 f.  The chills continued until about 6AM, I was sore all over, and had a low grade headache.  After that, the chills abated, and I got up to examine my upper arm which is extremely sore.  At present the area of my right upper arm has 3 50cent sized red blotches surrounding the vaccination area, and a Temp of 100f, with a continued low grade headache and some stiffness.  I don't consider these symptoms serious, however, thought due to the fact the symptoms were appearing  a day and a half after the vaccination, or more it may be of some limited interest.  I recieved one vaccination in each shoulder, with the right being inflamed, and no reaction in the left....I appologize that I do not know which of the two vaccinations was given in the right, or the left..  I was given these injections, due to the fact that I am recently recovering from severe clotting in my lungs, with further complications of fluid building up several times in my lungs, after clotting was controlled. I am currently taking 12 mg of Coumadin, and 10 mg of adderall per day... I was recently on predlesone and Tequin to clear up the after effect lung infection/fluid problem, however that regimen ended several weeks ago.  I know its no big deal, I was just reading how these symptoms usually appear shortly after injection, and last a day or two...I really had almost no symptoms till well after 24 hrs...and several continue rather painfully 42 hours later.  The chills are gone.  muscle sorenss improved, but outer tricep still extremely sore over much of it's area, with the blotches I described.  I									U	10/17/2002	10/18/2002	1		PVT	PVT	Comadin 12mg Adderall 10mg		see symptoms description			1						1	Chills; Coagulopathy; Erythema; Headache; Lung disorder; Musculoskeletal stiffness; Pain; Pyrexia; Rash macular; Body temperature increased; Chills; Erythema; Headache; Inflammation; Musculoskeletal stiffness; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~2	USA		Influenza
0191599	10/19/2002	WI	45.0	45		M	10/19/2002	Recieved Pnuemonia and influenza injections on Thurs 10/17 at 3pm. My upper arm was mildly sore but not red upon awakening friday AM. By friday 10 PM it was extremely sore, to the point brushing it lightly was painful- however area was not red, at about 11:30 pm I suddenly developed severe chills, to the point where I crawled in my -20 f northface sleeping bag, despite the room temp being 72 f.  The chills continued until about 6AM, I was sore all over, and had a low grade headache.  After that, the chills abated, and I got up to examine my upper arm which is extremely sore.  At present the area of my right upper arm has 3 50cent sized red blotches surrounding the vaccination area, and a Temp of 100f, with a continued low grade headache and some stiffness.  I don't consider these symptoms serious, however, thought due to the fact the symptoms were appearing  a day and a half after the vaccination, or more it may be of some limited interest.  I recieved one vaccination in each shoulder, with the right being inflamed, and no reaction in the left....I appologize that I do not know which of the two vaccinations was given in the right, or the left..  I was given these injections, due to the fact that I am recently recovering from severe clotting in my lungs, with further complications of fluid building up several times in my lungs, after clotting was controlled. I am currently taking 12 mg of Coumadin, and 10 mg of adderall per day... I was recently on predlesone and Tequin to clear up the after effect lung infection/fluid problem, however that regimen ended several weeks ago.  I know its no big deal, I was just reading how these symptoms usually appear shortly after injection, and last a day or two...I really had almost no symptoms till well after 24 hrs...and several continue rather painfully 42 hours later.  The chills are gone.  muscle sorenss improved, but outer tricep still extremely sore over much of it's area, with the blotches I described.  I									U	10/17/2002	10/18/2002	1		UNK	UNK	Comadin 12mg Adderall 10mg		see symptoms description			1						2	Chills; Coagulopathy; Erythema; Headache; Lung disorder; Musculoskeletal stiffness; Pain; Pyrexia; Rash macular; Body temperature increased; Chills; Erythema; Headache; Inflammation; Musculoskeletal stiffness; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~2	USA		Influenza
0191600	10/20/2002	MA	65.0	65		M	10/20/2002	As I was driving home after having my flu shot, I noticed I was having trouble hearing my car radio. I did not pay much attention to this.  After entering my house approximately 30-45 minutes after getting the shot, I had a severe dizzy spell. I had to sit down to keep from falling. After approximately five minutes, the dizziness went away.  I went outside and cut my lawn. About an hour later I came into the house, turned on the TV and had severe trouble hearing the sound.  This continued throughout the day. By evening all I could hear was squeaks and crackling sounds. It sounded like a cell phone breaking up. This remained the same at any volume. I could no longer distinguish words or music. When I woke up the next morning, conditions had not changed.  My wife made an appointment to see an ear, nose, throat doctor at Hospital. My ears were examined and tested. They could find no reason for my hearing loss and had no knowledge of this being a possible reaction to the flu shot. I contacted Dr.'s office and reported my problem.  He got back to us later in the day and left a message stating that he knew of nobody having this type of reaction from the shot, but if it was a reaction it would probably clear up within 24-48 hours. Condition did not change throughout the rest of the day and evening (Friday). On Saturday morning upon waking, my hearing was returning, but I had loud ringing in my ears. As the day wore on, my hearing continued to improve. As of now, Sunday evening, my hearing seems to have returned completely and may even have improved some.				Y					Y	10/17/2002	10/17/2002	0	None since recovery	PVT	UNK		Prostrate Cancer				1						1	Dizziness; Hypoacusis	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0191552	10/21/2002	MA	68.0	68		M	10/17/2002	68 year old male reported to have received two vaccines (flu and pneumonia). Ambulance was called. Pt was purple from neck up. Medical examiner declined autopsy.	Y	10/15/2002							N	10/15/2002	10/15/2002	0		OTH	UNK			HTN, DM			1						1	Skin discolouration	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Results in Death	Influenza
0191554	10/21/2002	KY	2.0	1	1	M	10/14/2002	Onset of temperature low grade, after shots. Seizure 4 minutes with apnea, requiring 1 day hospitalization; after ER visit.				Y	Y	1			Y	10/11/2002	10/12/2002	1	Seizure,all labs normal	PVT	PVT	None	None	None			1						1	Apnoea; Convulsion; Pyrexia	FLU3~EVANS VACCINES~E31872A~1~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HBHEPB~MERCK & CO. INC.~0452M~3~IM~RL~HIB + HEP B (COMVAX)~1|IPV~SANOFI PASTEUR~U1234~3~SC~LA~POLIO VIRUS, INACT. (IPOL)~1	USA	Hospitalisation	Influenza
0191555	10/21/2002	IN	46.0	46		F	10/15/2002	Deltoid area of R arm has 2 very small red raised areas at injection site, larger red area about 1 below injection site and an even larger approximately 2 1/2 x 4cm/red area on anterior aspect of upper arm-all areas red/warm to touch, arm from elbow to shoulder sore.									Y	10/15/2002	10/15/2002	0	NONE	PUB	PVT	Femlirt	NONE	Had implant replacements 6 wks prior to vaccination.			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~EVANS VACCINES~e31825GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0165M~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0191556	10/21/2002	AZ	26.0	26		F	10/16/2002	12 post vaccination-awoke from sound sleep unable to breathe progressed to coughing disorientation, blurred vision, vomiting.									Y	10/14/2002	10/14/2002	0		MIL	PVT	Clarinex, Multi-vit, Sansone dietary supplement	NONE	Treatment: otitis media (Sept)-seasonal allergies			1						1	Cough; Dyspnoea; Vision blurred; Vomiting	FLU3~SANOFI PASTEUR~U0968A2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191558	10/21/2002	IL	78.0	78		F	10/16/2002	Pt c/o feeling feverish and weak on Saturday 10/12 R arm at site of vaccination and extending to elbow was red, swollen and itchy. She stated she did call the local ER for advice but was not seen by a physician. Saw personal physician 10/14/02.									Y	10/11/2002	10/12/2002	1		PVT	UNK		NONE	NONE			1						1	Asthenia; Injection site erythema; Injection site hypersensitivity; Injection site oedema; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~U0903AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1159L~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0191559	10/21/2002	WA	55.0	55		F	10/16/2002	Swollen, raised lump-painful.									Y	10/07/2002	10/08/2002	1	NONE	PVT	PVT	Nifedipine caps 10mg 2 a day, Penioxifylline tabs 400mg 2 a day, Prilosec caps 20mg 1 a day, Verapamil tabs 240mg 1 a day, Prednisone 14mg once a day, Methotrexate tabs 2.5mg 8 tablets once a week, Zyrtec 10mg once a day, Flonase nasal spra	NONE	Hypertension, polomyositis			1						1	Oedema; Pain; Rash maculo-papular; Skin nodule	FLU3~PFIZER\WYETH~4020018~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~SANOFI PASTEUR~U0816AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0191561	10/21/2002	OK	77.0	77		F	10/14/2002	Pt woke up 10/10/02 with pain, swelling, erythema and induration of lateral aspect of left upper arm.									Y	10/09/2002	10/10/2002	1		PVT	PVT	Diovan hct, Zoloft, Boxtra	NONE	NKA			1						1	Injection site erythema; Injection site induration; Injection site oedema	FLU3~EVANS VACCINES~E35472HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0358M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0191562	10/21/2002	ME	61.0	61		M	10/15/2002	Erythema, tenderness at site. Patient states that the soreness involved his entire deltoid. He was treated with Keflex and states that the arm wsa back to normal by 10/8/02.				Y					U	09/30/2002	10/02/2002	2	NONE	PVT	UNK						1						1	Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U0904CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1161L~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0191563	10/21/2002	IA	13.0	13		M	10/14/2002	L arm allergic reaction with cellulitis 10/6/02. Emycin 333 tid x 10d. Prednisone 10mg 2 x day until gone x 7 days.				Y					Y	10/03/2002	10/06/2002	3	WBC inc 13,000 L arm swelling, redness; CRP 87.2  17.2	PVT	UNK	Clarinex Vioxx, Singulair, Tylenol	URI within 2 weeks	Allergic pcn, Kawasaki's disease-age 2.			1						1	Cellulitis; Hypersensitivity; Injection site reaction; White blood cell count increased	FLU3~EVANS VACCINES~E33472HA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0445H~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0191564	10/21/2002	PA	21.0	21		F	10/14/2002	Pt reported injection site to be red, puffy, swollen, hot to touch 24 hours post injection. Advised Tylenol or Motrin, OTC Benadryl and cool compresses call if worsening. Symptoms reported by pt.									U	10/10/2002	10/11/2002	1	NONE	PVT	PVT	Prednisone, Singulair, Flexril, Carafate, Urocet, nexium, Rhinocort, Reckee		Midepigastric pain-chronic, hx of def. anemia			1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U0929AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191565	10/21/2002	IL	32.0	31		F	10/09/2002	Pt felt bad and began running a fever. The next morning she called the pharmacy and stated she was feeling ill. Pt went to ER on Wednesday night and received IV antibiotics and a prescription for 5 days of oral antibiotics. Talked to pt on 10/9 and she is doing better. Arm is still sore and said the ER physician diagnosed cellulitis.				Y					Y	10/02/2002	10/02/2002	0		OTH	PVT						1						1	Cellulitis; Injection site pain; Injection site reaction; Malaise; Pyrexia	FLU3~SANOFI PASTEUR~U0875AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1352L~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0191566	10/21/2002	PA	65.0	65		F	10/10/2002	Day one-approximately five hours after vaccination swelling-upper right arm from shoulder to elbow-approximately the size of a football-slight rash at site-severe pain and restricted movement of arm. Pt took 2 aspirin for pain prior to bedtime. No relief. Pt believes she ran high fever during night because in morning believed she had been hallucinating throughout night. Day two-pain, swelling, rash and restricted movement of arm persists. Nurse at physicians office advised (over phone) tylenol and icing swollen arm. Pain and rash subside, swelling does not. Day 3-AM pt pain free, has full movement of arm. Swelling remains. Pt stops tylenol and icing. Approximately 48 hours after vaccination pt feels severe restriction around right elbow. Swelling has now extended from right shoulder to a point midway between right elbow and right wrist. Pt also feel swelling in right ring finger and numbness in right little finger. Swelling and numbness also in right upper lip. Rash from right arm pit extending throughout swollen area. Pt visits doctor who states it is an allergic reaction to vaccine. Temperature 99.3. Prescribed #21 methylpredisolone dosepak, 4mg. and antihistamine (pt took Allegra D120mg) 2x per day. Day 4-all symptoms subside except for swelling which remains through day 6.				Y					Y	10/01/2002	10/01/2002	0		PVT	OTH	Synthroid, Fosomax	NONE	Uneractive thyroid, thyroid nodule not yet biopside, osteocuenia			1						1	Hypoaesthesia; Injection site oedema; Injection site pain; Injection site rash; Joint range of motion decreased; Pyrexia	FLU3~SANOFI PASTEUR~U0928AA~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1052L~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0191603	10/21/2002	MI	66.0	66		F	10/21/2002	RAPID  HEART  BEAT.........3:A.M.    B/P   UP SLIGHTLY..........3:A.M.									Y	10/08/2002	10/09/2002	1		PVT	UNK	Lanoxin  .25  mg.  Coreg   12.5  mg. Vasotec  10   mg. aspirin   81  mg.	unknown.. on 10-08-02 sinus infection  10-09-02	high blood pressure cardiomyopathy,which recovered sinus allergies			1						1	Blood pressure increased; Heart rate increased	FLU3~SANOFI PASTEUR~U0873AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~O541M~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0191709	10/21/2002	NV	70.0	70		F	10/21/2002	Vaccine administered about 3PM.  About 11PM got out of bed and experienced vertigo which occurred several more times during the night.  Since I had experienced labryntitis in the late 1980's, I was cautious with my movements until Friday, the 11th when I sought help at the Health Center.  I received a prescription for MECLIZINE 25MGM TAB,(1/2) and DIAZEPAM 5MG TAB (1/4)for my trip home. When back in Reno 10/14, I experienced explosive diarrhea and vomiting for about 5 hours.  In a few days with no other symptoms I gradually returned to normal. On this day, 10/21 I have residual symptoms.				Y					Y	10/09/2002	10/09/2002	0	None	PUB	PVT	None	None	Blood Presure Meds.			1						1	Diarrhoea; Vertigo; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0191604	10/22/2002	FL	90.0	90		F	10/28/2002	Pneumonia worsened: lack of appetite, lethargy, coughing blood on 12/15/01 and adm. to hosp.	Y	12/19/2001							N	12/13/2001	12/15/2001	2		OTH	PUB	NONE	Pneumonia	Alzheimer's, Alcohol Abuse, Varicose Veins			1						1	Condition aggravated; Decreased appetite; Haemoptysis; Lethargy	FLUX~UNKNOWN MANUFACTURER~90658~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~90732~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Results in Death	Influenza
0191618	10/22/2002	IN	75.0	75		F	10/06/2002	Both flu and pneumonia shots given on 10/4/02 in different arms. One day later arm became very swollen and sore R arm where pneumonia shot given. She became very weak and fell x 2. Went to MD and he placed in hospital x 2 days with IV antibiotics. Vomiting, diarrhea, and dehydration.				Y	Y	2			Y	10/04/2002	10/05/2002	1		PUB	PVT	Norvase; Synthroid; Evista; Orthotec	NONE	Hypothyroidism; HTN; Arthritis; Fluid Retention			1						1	Asthenia; Cellulitis; Dehydration; Diarrhoea; Fall; Injection site oedema; Injection site pain; Pyrexia; Vomiting; Asthenia; Fall; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U0911AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1160L~2~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~PARKDALE PHARMACEUTICALS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~MERCK & CO. INC.~1160L~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0191620	10/22/2002	KY	45.0	45		F	10/21/2002	Nausea, flushed face, difficulty swallowing, short of breath. Seen in ED, treated with Solumedrol, Pepcid IV, Discharged home with Prednisone dose pack and Tagamet. Seen in ED again 10/16 then hospitalized 10/17 for continued					Y	2			Y	10/15/2002	10/15/2002	0		PVT	PVT	Effexor, Tagamet, Lasix, Zyrtec, Lotril		Bactrim, Tetanus			1						1	Dysphagia; Dyspnoea; Flushing; Nausea; Dysphagia; Dyspnoea; Flushing; Leukocytosis; Nausea; Thrombocythaemia	FLU3~SANOFI PASTEUR~U0910AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0910AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0191628	10/22/2002	GA	75.0	75		F	10/03/2002	Patient reports after getting home, noticed redness and swelling. States swelling occurred from injection site to elbow. Redness, swelling and warmth noted to elbow today. Patient states improving since 10/02/02.									Y	10/01/2002	10/01/2002	0		PUB	PUB	B-12; Asthma corticoid; Albuterol inhaler; Hyzaar	Diabetes; Asthma			GA02113	1						1	Feeling hot; Injection site erythema; Injection site swelling	FLU3~EVANS VACCINES~34682HA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1352L~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0191629	10/22/2002	GA	69.0	69		F	10/11/2002	Has swelling at injection site R arm. Redness as well.									Y	10/10/2002	10/10/2002	0	NONE	PUB	PUB	Tamoxifer, Plaquanel, Platol, Thedir, vitamins	NONE	Some antibiotics pcn, codeine, udocaine		GA02112	1						1	Injection site erythema; Injection site oedema	FLU3~EVANS VACCINES~34682NA~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1159L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0191630	10/22/2002	GA	5.0	5		M	10/10/2002	Fever and swelling at site of injection.									Y	10/07/2002	10/09/2002	2		PUB	PUB	None	None	Lorabid		GA02111	1						1	Feeling hot; Injection site swelling	DTAP~SMITHKLINE BEECHAM~574A2~5~IM~LA~DTAP (INFANRIX)~1|FLU3~EVANS VACCINES~E34682GA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0191631	10/22/2002	GA	34.0	34		F	10/08/2002	On the after post receiving flu vaccine, pt began feeling dizzy. By 3-4 hours later pt woke up and eyes were swollen shut. By am, pt was feeling generalized fatigue, neck was stiff, arm where shot was administered was very sore.				Y					Y	10/01/2002	10/01/2002	0		PUB	PUB	Foloft 100mg po	NONE	Depression		GA02110	1						1	Dizziness; Eye oedema; Fatigue; Injection site pain; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U0925AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191632	10/22/2002	GA	67.0	67		F		Reddened area quarter size; soreness; warm to touch.									U	10/01/2002	10/02/2002	1		PUB	PUB		None	None		GA02109	1						1	Feeling hot; Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U0925AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0923L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0191633	10/22/2002	GA	42.0	42		M	10/03/2002	Flu shot given 9/30/02 at 3:30pm. 10//02 around 3pm arm began to become sore and warm to touch. Arm check 10/3/02 area slight warm to touch with no swelling. Cold to area, to take Advil and Benadryl.									Y	09/30/2002	10/01/2002	1		PUB	PVT	NONE	NONE	NONE		GA02108	1						1	Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U0925AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191634	10/22/2002	CA	46.0	46		F	10/15/2002	Cellulitis left arm, extreme swelling left arm and fever of 100.4. Discomfort lasted approximately 1 week. Note: reported 10/10/02 to us.				Y					Y	10/08/2002	10/09/2002	1		PVT	PVT	Nexium; Cyclessa	None	None			1						1	Cellulitis; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U0968AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1050L~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0191635	10/22/2002	AR	77.0	77		M	10/15/2002	Hives/urticaria. Treatment = Claritin 10mg #10.									Y	10/11/2002	10/12/2002	1	None	OTH	OTH	Procardia					1						1	Urticaria	FLU3~PFIZER\WYETH~4020022~5~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0191636	10/22/2002	SC	30.0	29		F	10/14/2002	Soreness of index and middle finger of the left hand. Difficult to bend index finger. Fingers are still sore but not difficulty in bending. No numbness. Circulation fine.									Y	10/11/2002	10/12/2002	1	NONE	PUB	UNK	Occ ultram	NONE	NONE			1						1	Arthralgia	FLU3~SANOFI PASTEUR~U0877AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191637	10/22/2002	PA	32.0	32		F		Pt seen 10/16/02 12x8cm erythema/induration at site of injection, developed over lost 24 hours since injection. Resolving as of 10/18/02.				Y					Y	10/15/2002	10/16/2002	1	NONE	PVT	PVT	Levothproxne 0.05mg	NONE	HYpothyroidism			1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U0905FA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191638	10/22/2002	SC	67.0	67		F	10/15/2002	Half-dollar size swelling and itching at injection site. Accompanied with fever at injection site noticed about 3 hours after vaccine administered. Treated with Allegra 180mg PO QD for 7 days prescribed by PMD.				Y					Y	10/15/2002	10/15/2002	0		PUB	OTH	Coumadin; Nadadol; Pamalar 25mg	None	NKA, Blood clot left leg			1						1	Feeling hot; Injection site hypersensitivity; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U0921DA~7+~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1353L~2~~LA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U0524AA~5~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0191639	10/22/2002	FL	72.0	72		F	10/17/2002	Pt denies fever, chills. Shortly after injection site red, arm swollen. Next day still with swelling redness to affected arm. Two days after injection couldn't raise arm, eyes swollen, cheeks inflammed. Three days some SOB. Seen 10/14/02-face swollen, swelling pain left arm. Tx: Madrol dose pak and Benadryl. Still resolving.				Y					Y	10/10/2002	10/10/2002	0	NONE	PVT	PVT	Enalapril maleate, Armour thyroid, hydrochlorot, potssium chloride, Prevacid, quinine sulfate, Proctosol HC, Elocon, Multivitamins, Lorazepam, Medrol	NONE	Synthroid, E-mycin, sulfa, IVP dye; depression; lumbago; venous insufficiency; arthralgias; allergic reaction; abnormal mammogram; hypertension; thyrotoxicosis NOS			1						1	Dyspnoea; Eye oedema; Face oedema; Hypokinesia; Injection site erythema; Injection site oedema; Pain	FLU3~EVANS VACCINES~E32982Ga~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0358M~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0191640	10/22/2002	FL	76.0	76		F	10/17/2002	Patient denies fever or chills. Swelling of left arm above elbow to the shoulder. Initially 3 circle at affected area, redness, itching, swelling. Received Solumedrol injection 125mg. 10/17/02 Still itches; faded bruising yellow/green				Y					Y	10/10/2002	10/10/2002	0		PVT	PVT	Monopril; Maxzide, Lopressor; Lipitor; Xanax; Tavist; Protonix; Citrucel; Colyte Recon Sol; Kenalog; Vitamin E; Vitamin C; Mag-Oxide; Melatonin; Bion Tears; Trimo-San; Westcort; Kenalog in Orabase;	Ear pain/pressure	Demerol; Morphine; Thorazine; Ampicillin; Macrodantin; Mycostatin; Flagyl; Stelazine; Compazine; Dulcolax; Reglan; Procardia; Tuss-Ornade; Motrin; Naprosyn; Feldene; ASA; Midrin; Symmetrel; Phenazopyridine; Prilosec; Chronulac Syrup; Pred G Drops; Bacitracin Opth Ointment; Dicyclomine; Zithromax; Ultracet; Pneumovax			1						1	Contusion; Erythema; Injection site swelling; Pruritus	FLU3~EVANS VACCINES~E329926A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0358M~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0191641	10/22/2002	CA				F	10/18/2002	Client Employee called to say today that her Lt arm above the elbow is red, sore and swollen since site had the flu vaccination Monday 10/14/02.				Y					U	10/14/2002				OTH	PVT						1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U0921DA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191642	10/22/2002	CA	59.0	59		F	10/21/2002	Chills. Arm (left) continues to swell down to elbow and around inside arm-almost completely circles arm. Arm extremely sore to touch where swollen. Swollen area of arm very hot. Thurs. was freezing and by afternoon had the shakes. I was so cold, my hands were numb. Took bath to get warm. Took my temperature-it was 104. Had sweats. Missed work on 10/18/02.									U	10/16/2002	10/16/2002	0		PVT	PVT	Nexium, Premarin, Thypoxine	NONE	Asthma as a child			1						1	Chills; Hyperhidrosis; Hypoaesthesia; Injection site oedema; Injection site pain; Injection site warmth; Pyrexia; Tremor	FLU3~EVANS VACCINES~E30422GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~O165M~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0191643	10/22/2002	FL	40.0	40		M	10/21/2002	Diarrhea starting 48 hours after vaccine, lasting 3 days, untreated, no nausea or other discomfort.									Y	10/15/2002	10/17/2002	2		OTH	PVT		NONE	NONE			1						1	Diarrhoea	FLU3~SANOFI PASTEUR~U0922AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191644	10/22/2002	LA	62.0	62		F	10/21/2002	Red rash.									U	10/17/2002	10/18/2002	1		UNK	UNK						1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0177610	10/23/2002	TN	40.0	40		F	11/05/2001	It was reported that a 40 year old female patient received a Fluzone SV '01-'02 vaccination, lot number U0681AA, on 10/26/01 at 6:20PM administered in her left deltoid. Within ten minutes the patient experienced heart arrythmia, her airway became tight, she was nauseous and sweating. Patient was administered EpiPen 0.3mg and 911 was called. Patient taken to emergency room. The employee of the pharmacy that administered the product spoke with the patient and the patient stated the doctors at the ER determined her reaction was due to lactose intolerance. She recovered from this experience.				Y					Y	10/26/2001	10/26/2001	0		OTH	OTH					U200101114	1						2	Arrhythmia; Hyperhidrosis; Nausea; Throat tightness	FLU3~SANOFI PASTEUR~U0681AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0177628	10/23/2002	NJ	44.0	44		F	11/28/2001	It was reported that a 44 year old male patient received a Fluzone SV '01 -02 vaccination, Lot number U0593AA, administered on 09/24/01. The patient was seen in physician's office on 09/28/01 with a large local reaction - 17 X 10 cm reddened area at the injection site and also small hives on her chest. Upon examination, the patient's lungs were clear.				Y					U	09/24/2001	09/28/2002	369		UNK	UNK					U200101024	1						2	Injection site reaction; Urticaria	FLU3~SANOFI PASTEUR~U0593AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0178784	10/23/2002	TX	39.0	39		F	12/26/2001	From correspondence received on 11/12/01, it was reported that a 39 year old patient received a Fluzone SV '01-'02 vaccination lot #UO685Aa, exp. 06/02. Patient received the dose on 11/09/01. She experienced a local reaction consisting of site very red with red streaks. The patient also received a pneumonia vaccine.									U	11/09/2001	11/09/2001	0		UNK	UNK					U200101141	1						2	Cellulitis; Injection site erythema	FLU3~SANOFI PASTEUR~UO685AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0923L~UNK~~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0179163	10/23/2002	NY	52.0	52		M	12/26/2001	It was reported that a 52 year old male patient received a Fluzone SV 2001-2002 vaccination on 11/15/01 at 17:00 administered in his right deltoid. On 11/16/01 the patient developed itchy red spots on the right deltoid area. By 11/17/01, the patient developed itching all over both arms. By 20:30 Saturday 11/17/01, patient has itching and red blotches which the patient calls hives over entire body. Took honey and oatmeal solution bath, applied anti-itch ointment and this calmed itching. Seen 11/18/01, 16:45 itching and red blotches reappeared. Repeat bath and ointment helped very little. At 20:00 patient went to ER. HE was given Prednisone 20mg bid PO x5 days. He has an appointment with primary physician on Friday 11/23/01. Patient reports he continues to have break-through itching and blotches between doses of Prednisone. Has occasionally taken Benadryl for itching. Patient works in a lumbar yard; is exposed to wood products, insulation, paints, stains, chemicals and concrete building products. Patient also works at building construction.				Y					N	11/15/2001	11/16/2001	1		PUB	PUB	Thyreoid	None	Multiple Sclerosis		U200101310	1						2	Erythema; Injection site hypersensitivity; Pruritus; Rash macular; Urticaria	FLU3~SANOFI PASTEUR~U0600UA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0179807	10/23/2002	PA	81.0	81		F	04/15/2002	It was reported by the patient that she; an 81 year old female received a Fluzone SV 2001-2002 vaccination on 10/6/01. The patient states, I dwindled into 4 weeks of complete misery, spending nights coughing my head off, not eating and sleeping well, and losing more than 12 pounds. The patient reportedly also lost her voice, which is finally slowly coming back after 6 weeks. The patient was prescribed antibiotic Zithromax on the 19th (month not specified) which helped. The patient's current recovery status is unknown. From additional correspondence received at manufacturer on 1/28/02 additional patient, vaccine, responsible physician and vaccine administrator information was provided. From follow up telephone conversation on 1/30/02 with the office manager at clinic, it was confirmed that the patient did receive Fluzone as reported and did experience laryngitis but all symptoms have resolved since then. Correction of vaccination date to 10/13/01.				Y					N	10/13/2001				PVT	PUB	Diazide, Tenormin, Xanax	Slight Cold; Laryngitis	HBP		U200101317	1						3	Dysphonia; Fatigue; Nasal dryness; Urine analysis abnormal; Cough; Decreased appetite; Insomnia; Laryngitis; Pharyngitis; Rhinitis; Weight decreased; Cough; Laryngitis; Oral intake reduced; Sleep disorder; Weight decreased	FLU3~SANOFI PASTEUR~U0681AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~00681AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~U0681AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Emergency room visit	Influenza
0179848	10/23/2002	IL	52.0	52		M	03/01/2002	From faxed correspondence received on 1/4/02 it was reported that a 52 year old male patient received a Fluzone SV 2001-2002 vaccination on 11/20/01. On 12/19/01 the patient was diagnosed with Guillain Barre Syndrome. He was hospitalized for eight days and is recuperating at home. His complete recovery may take three months. It is not expected that the patient will have any permanent disability. From additional correspondence received on 2/20/02 at manufacturer, it was reported: 2/6/02 I was notified that this person was readmitted to the hospital for 6 days for relapse of Guillain Barre. I have been in contact with the FDA. I believe they have a copy of this report.				Y	Y	8			N	11/20/2001	12/19/2001	29		PVT	PVT		None	Allergies to PCN, Sulfa, Epilepsy, Diabetes		U200200004	1						2	Guillain-Barre syndrome; Guillain-Barre syndrome	FLU3~SANOFI PASTEUR~UO671BA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0671BA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0180483	10/23/2002	IA	64.0	64		F	02/06/2002	From faxed correspondence received 01/17/2002, it was reported that 64 year old  female received a Fluzone SV '01-'02 USP injection on 11/29/01 in left deltoid. Immediately shot was painful, bled a lot. Given high on shoulder, one finger below bone. Bruised within 15 minutes. Arm ached all day, night and next day Knot at side still dime-sized. Administered IM in left deltoid.									U	11/29/2001	11/29/2001	0		PUB	PUB					U200200076	1						2	Contusion; Injection site haemorrhage; Injection site mass; Injection site pain; Ecchymosis; Injection site mass; Pain	FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~UO710AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0180487	10/23/2002	IA	51.0	51		F	02/06/2002	From correspondence received at manufacturer on 1/17/02 it was reported that a 51 year old female patient received a Fluzone SV 01-02 vaccination administered IM in her right deltoid on 11/29/01. That same day the patient's shoulder and arm became sore and warm. Upper forearm hurt Saturday night. Can't lift arm straight out or back such as to unhook bra or retrieve seat belt. Patient was seen by physicians and tried Ibuprofen (800mg) with heat on arm but no relief. Bursitis and Hergein anti-imflammatory and ice tried without relief. Seen by physician and was given Cortizone injection and diagnosed with tendonitis.				Y					U	11/29/2001	11/29/2001	0		UNK	UNK					U200200075	1						2	Bursitis; Hypokinesia; Injection site pain; Injection site warmth; Pain; Tendonitis; Feeling hot; Injection site reaction; Joint range of motion decreased; Tendonitis	FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0180544	10/23/2002	IA	44.0	44		F	02/06/2002	From correspondence received at manufacturer on 1/17/02 it was reported that a 44 year old female patient received a Fluzone SV 01-02 vaccination administered in her left deltoid, IM on 10/8/01. The injection was immediately painful and deltoid area swelled. Patient now has decreased ROM. Arm can't swing towards back and unhook bra or buckle a seat belt. Arm is weak, can't reach arm above head. Painful at night, aches all the time. Lying down causes increase in pain. Bursitis, given VIOXX with no relief. Per patient...now January, two to three times a week she sees muscle therapist or the doctor.				Y					N	10/08/2001	10/08/2001	0		UNK	UNK					U200200077	1						4	Hypokinesia; Injection site oedema; Injection site pain; Muscular weakness; Pain; Bursitis; Injection site pain; Injection site swelling; Joint range of motion decreased; Neck pain; Bursitis; Hypokinesia; Injection site reaction; Muscular weakness; Myalgia; Tendonitis; Injection site reaction; Injection site swelling; Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~4	USA	Emergency room visit	Influenza
0180655	10/23/2002	MI	72.0	71		F	02/06/2002	From correspondence received at manufacturer on 1/17/02 it was reported that a 72 year old female patient received a Fluzone SV 01-02 vaccination administered on 11/12/01. That same day the patient developed a sore arm and had two red spots. Fluzone was administered IM in right arm. Reportedly the patient recovered from this experience.									Y	11/12/2001	11/12/2001	0		UNK	UNK					U200200073	1						2	Injection site erythema; Injection site pain; Erythema; Pain	FLU3~SANOFI PASTEUR~U0703AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0180720	10/23/2002	MO	17.0	17		F	04/15/2002	From mailed correspondence received at manufacturer on 2/6/02 it was reported that a 17 year old female patient had received an influenza vaccination (Fluzone SV 01-02 USP lot number U0574AA) on 10/26/01. Reportedly client describes a red rash at injection site (IM, left deltoid) 2 days after vaccination, then reports indentation (muscular atrophy) that was noted on patient's left deltoid. Reportedly the patient recovered from this experience.									Y	10/26/2001	10/28/2001	2		PUB	PVT		None	None		U200200270	1						2	Injection site erythema; Injection site rash; Muscle atrophy; Injection site erythema; Injection site rash; Muscle atrophy	FLU3~SANOFI PASTEUR~U0574AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0574AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0180859	10/23/2002	MI	62.0	62		F	02/06/2002	From correspondence received on 02/01/02, it was reported that a 62 year old white female is reporting her own Adverse Events although she states her doctor's office completed a VAERS form today. She was administered Fluzone Lot # UO575AA on 10/31/01. She reports that her arm became red and swollen the same day. The next day her breathing was difficult. Two days later she had chills and itchy rash. The rash came about three times a day, then went away. She has bouts of vomiting and diarrhea on and off. She has been seen at a clinic and told that vaccines can cause an auto immune response. She was also told never to get this vaccine or she can die.									U	10/31/2001	11/01/2001	1		UNK	UNK					U200200051	1						3	Chills; Diarrhoea; Dyspnoea; Pruritus; Rash; Skin ulcer; Swelling; Vomiting; Injection site reaction; Injection site swelling; Rash; Chills; Diarrhoea; Dyspnoea; Injection site reaction; Pruritus; Rash; Vomiting	FLU3~SANOFI PASTEUR~U0575AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0575AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~UO575AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA		Influenza
0180900	10/23/2002	MI	47.0	54		F	02/06/2002	From correspondence received at manufacturer on 1/28/02 it was reported that a 47 year old female patient received a Fluzone SV 01-02 vaccination, administered IM in the left arm. Reportedly, the patient state her arm bruised after receiving the flu vaccine. She was instructed to apply ice. The patient recovered from this experience.				Y					Y	10/25/2001	10/26/2001	1		UNK	UNK					U200200079	1						2	Contusion; Contusion	FLU3~SANOFI PASTEUR~V0575AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0575AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0180901	10/23/2002	MI	42.0	42		F	02/06/2002	From correspondence received at manufacturer on 1/28/02 it was reported that a 42 year old female patient received a Fluzone SV 01-02 vaccination administered IM in the left arm. The patient stated she got sick after receiving flu vaccine. Had fever of 100 degrees, no arm soreness. Patient stayed home and rested. Symptoms resolved.									Y	11/03/2001	11/05/2001	2		UNK	UNK					U200200080	1						2	Pyrexia; Malaise; Pyrexia	FLU3~SANOFI PASTEUR~U0685AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0685AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0180902	10/23/2002	MI	24.0	24		F	02/06/2002	From correspondence received at manufacturer on 1/28/02 it was reported that a 24 year old female patient received a Fluzone SV 01-02 vaccination administered IM in the left arm. Reportedly the same day the patient felt sick all day. Has emesis x2 and swollen injection site area. Did not apply ice. on 11/5/01 no fever, but still swollen arm. She was advised to see doctor if not better.				Y					U	11/03/2001	11/03/2001	0		UNK	UNK					U200200081	1						2	Injection site oedema; Vomiting; Injection site swelling; Malaise; Vomiting	FLU3~SANOFI PASTEUR~U0685AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0685AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0180903	10/23/2002	MI	49.0	49		F	02/06/2002	From correspondence received at manufacturer on 1/28/02 it was reported that a 49 year old female patient received a Fluzone SV 01-02 vaccination on 10/31/2001, administered IM in the left arm. Reportedly on 11/2/01 the patient complained of soreness at the injection site. Patient was instructed to apply ice and take Tylenol. Symptoms resolved.				Y					Y	10/31/2001	11/02/2001	2		UNK	UNK					U200200082	1						2	Injection site pain; Injection site reaction	FLU3~SANOFI PASTEUR~U0685AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0385AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0180904	10/23/2002	MI	55.0	55		F	02/06/2002	From correspondence received at manufacturer on 1/28/02 it was reported that a 55 year old female patient received a Fluzone SV 01-02 vaccination on 11/3/01, administered IM in the left arm. Reportedly on 11/6/01 the patient complained of a bruise on her arm that was hot to the touch and itchy. Patient was instructed to apply ice and take Tylenol. Symptoms resolved.				Y					Y	11/03/2001	11/06/2001	3		UNK	UNK					U200200083	1						2	Contusion; Feeling hot; Pruritus; Contusion; Feeling hot; Pruritus	FLU3~SANOFI PASTEUR~U0685AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0685AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0180905	10/23/2002	MI	85.0	85		F	02/06/2002	From correspondence received at manufacturer on 1/28/02 it was reported that an 85 year old female patient received a Fluzone SV 01-02 vaccination on 10/31/01, administered IM in the left arm. Reportedly on 11/9/01 the patient complained of discoloration at the injection site. On 11/12/01, the patient stated color was better and she was doing ok.									Y	10/31/2001	11/09/2001	9		UNK	UNK					U200200084	1						2	Injection site reaction; Skin discolouration; Injection site reaction; Skin discolouration	FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0180906	10/23/2002	MI	34.0	34		F	02/06/2002	From correspondence received on 01/28/02, it was reported that a 34 year old female patient received a Fluzone SV '01-'02 vaccination on 11/06/01, administered IM in left arm. Reportedly, the patient developed a reddened, itchy,puffy and nickle-size area on her left cheek one hour after immunization. She was given an ice pack and instructed to call physician if any concerns. On 11/12/01, symptoms resolved				Y					Y	11/06/2001	11/06/2001	0		UNK	UNK					U200200085	1						2	Erythema; Pruritus; Swelling face; Face oedema; Pruritus; Rash	FLU3~SANOFI PASTEUR~0685AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~0685AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0180907	10/23/2002	MI	38.0	38		F	02/07/2002	From correspondence received at manufacturer on 1/28/02 it was reported that a 38 year old female patient received a Fluzone SV 01-02 vaccination on 11/13/01 administered IM in the left arm. Reportedly the patient complained of a red rash with itching (generalized) 7 minutes after injection. She was given Benadryl 50 mg. After 3 hours of observation, client was ok.				Y					Y	11/13/2001	11/13/2001	0		UNK	UNK						1						2	Pruritus; Rash erythematous; Erythema; Pruritus; Rash	FLU3~SANOFI PASTEUR~U0703AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0703AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0180908	10/23/2002	MI	47.0	47		F	02/07/2002	From correspondence received at manufacturer on 1/28/02 it was reported that a 47 year old female patient received Fluzone SV 01-02 vaccination on 12/7/01, administered IM in left arm. Reportedly on 12/11/01 the patient complained of a sore arm and sore neck. On 12/17/01 the symptoms resolved and client felt sore neck was due to a bug.									Y	12/07/2001	12/11/2001	4		UNK	UNK						1						2	Myalgia; Pain	FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0180909	10/23/2002	MI	59.0	61		M	02/07/2002	From correspondence received at manufacturer on 1/28/01 it was reported that a 59 year old male patient received a Fluzone SV 01-02 vaccination on 10/24/01, administered IM in the left arm. Reportedly on 11/29/01, the patient complained of his shoulder hurting and not being able to move his arm (i.e. lift without aches). His arm was never red or swollen. Patient was advised to see a doctor.									U	10/24/2001	11/29/2001	36		UNK	UNK					U200200088	1						2	Joint range of motion decreased; Pain; Joint range of motion decreased; Pain; Shoulder pain	FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0180910	10/23/2002	MI	28.0	28		F		From faxed correspondence received  on 01/28/02, it was reported that a 28 year old female patient  a Fluzone SV '01-'02 vaccination on 11/16/01 administered IM in left arm. Reportedly, on 11/19/01, the patient  complained  of redness , swelling and itching at the site of injection. The patient was instructed to apply ice. On 12/03/2001, symptoms resolved.				Y					Y	11/16/2001	11/19/2001	3		UNK	UNK					U200200089	1						2	Injection site erythema; Injection site hypersensitivity; Injection site oedema; Pruritus; Injection site erythema; Injection site reaction; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U0703AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~UO703AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0180911	10/23/2002	MI	11.0	11		M	02/07/2002	From correspondence received at manufacturer on 1/28/02 it was reported that an 11 year old male patient received a Fluzone SV 01-02 vaccination on 11/5/01 administered IM in the left arm. Reportedly the patient complained of some itching a few minutes after vaccination. No redness was noted. Ice was applied to site and that stopped the itching. On 11/6/01 arm was still a little sore.									U	11/05/2001	11/05/2001	0		UNK	UNK					U200200090	1						2	Pruritus; Injection site hypersensitivity; Pruritus	FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0600AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0180912	10/23/2002	MI	69.0	69		M	02/07/2002	From correspondence received at manufacturer on 1/28/02 it was reported that a 69 year old male patient received a Fluzone SV 01-02 vaccination administered on 11/5/01, IM in left arm. The patient complained of vomiting 2 days after vaccination. On 11/15/01 symptoms resolved. Patient felt vomiting was not associated with vaccine.									Y	11/05/2001	11/07/2001	2		UNK	UNK					U200200091	1						2	Vomiting; Vomiting	FLU3~SANOFI PASTEUR~U0685AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0685AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0181930	10/23/2002	NJ	68.0	68		M	04/01/2002	It was reported by an RN from a health department that a 68 year old male patient received a Fluzone SV 2001-2002 vaccine administered on 11/1/2001. The RN obtained information from the wife of patient who stated that several days after the flu shot, her husband noticed weakness, became tired and lethargic. On 12/26/01, legs became painful. On 12/28/01, calves of legs became swollen and difficulty walking. On 12/29/01 could only lay flat. On 12/31/01, couldn't walk and couldn't use his hands, was admitted to hospital that day, remained in ICU for one week, total hospital stay was 2 weeks duration. Patient was diagnosed with GBS. Currently in rehab. The RN stated that this patient was taking daily doses of Lipitor. From additional correspondence received at manufacturer, on 4/1/02 it was reported: Progressive lethargy and weakness, no ability to walk or use arm. Diagnosed with GBS by spinal tap. Hospitalized 12/31/01 to 1/14/02. Transferred to rehab on 1/14/02--still there. Patient discharged from rehab late February. As of this date 3/18/02 still unable to tie shoes, ambulatory with assistive device--still undergoing OP therapy.			Y	Y	Y	14			N	11/01/2001	12/01/2001	30	CSF - positive GBS	PUB	PUB	Lipitor	None			U200200095	1						2	Abasia; Asthenia; Guillain-Barre syndrome; Lethargy; Neurodevelopmental disorder; Asthenia; Difficulty in walking; Fatigue; Guillain-Barre syndrome; Lethargy; Pain; Swelling	FLU3~SANOFI PASTEUR~U0588AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0588AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0182781	10/23/2002	IL	46.0	46		F	04/01/2002	From correspondence at manufacturer on 3/28/01 it was reported that a 46 year old female patient received Fluzone SV 01-02 vaccination on 10/26/01. Reportedly on 10/29/01 the patient developed a local reaction of redness and soreness. No fever, shaking, chills, no evidence of cellulitis. Reportedly the patient recovered from this experience. This report is linked with case #U200101092 abd U200200237.									Y	10/26/2001	10/29/2001	3		OTH	OTH			NKDA		U200200238	1						2	Injection site erythema; Injection site pain; Injection site erythema; Injection site pain; Injection site reaction	FLU3~SANOFI PASTEUR~0593AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0593AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0191715	10/23/2002	IN	50.0	50		M	10/07/2002	Patient received Flu and Pneumonia shot in left deltoid. Arm became extremely swollen and painful. Patient was told to seek medical advice. Patient was placed on Augmentin 500mg and moist heat and Tylenol.				Y	Y	3			Y	10/02/2002	10/03/2002	1		PUB	PVT	Effexor; Lipitor	None	Hypercholesterolemia; Depression			1						1	Pain; Swelling; Injection site oedema; Injection site pain; Muscular weakness	FLU3~SANOFI PASTEUR~U0911AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~1160L~1~IM~LA~PNEUMO (PNU-IMUNE)~1|PPV~MERCK & CO. INC.~1160L~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0191729	10/23/2002	GA	37.0	37		F	10/16/2002	10/16/02 Client phoned to state left arm was sore and very swollen. Requested client to come in for an assessment. 5:00 PM on 10/15/02 noticed soreness and swelling to left arm at injection site. Today 10/16/02 at 11:00 AM, there is redness noted from deltoid to elbow region--area is edematous and tender to touch. Looks like cellulitis. Temperature is 95.8 degrees F. Client was referred to MD for evaluation. Client saw MD today and was given a steroid shot for inflammation and placed on Keflex 500mg for 1 one.				Y					Y	10/15/2002	10/15/2002	0		PUB	PUB	Allegra; Rhinecort Nasal Spray; Max-air inhaler	None	Seasonal allergies			1						1	Body temperature decreased; Injection site erythema; Injection site pain; Injection site swelling; Tenderness	FLU3~EVANS VACCINES~E33482HA~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0923L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0191730	10/23/2002	CO	6.0	6		M	10/11/2002	6cm area of redness, induration and swelling at 48 hours after shot; right deltoid.									Y	10/09/2002	10/09/2002	0	None	PVT	PVT	None	None	NKDA			1						1	Erythema; Injection site induration; Injection site swelling	DTAP~SMITHKLINE BEECHAM~553A2~5~IM~RA~DTAP (INFANRIX)~1|FLU3~EVANS VACCINES~E31902HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~MERCK & CO. INC.~1558K~1~IM~RA~HEP A (VAQTA)~1	USA		Influenza
0191731	10/23/2002	TX	1.7	1	.7	F	10/15/2002	Fever 39 degrees C 3 hours after administration accompanied by urticarial rash.									Y	10/15/2002	10/15/2002	0	None	PVT	PUB	Pulmocort; Albuterol	None	Asthma			1						1	Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U0877AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191732	10/23/2002	TN	37.0	37		F	10/14/2002	Pt became nauseous approximately 5 minutes after receiving the influenza vaccine. She also felt heart racing. Began itching about 10 minutes following innoculation. Gave 25mg diphenhydramine po. Felt better within 20 minutes.									Y	10/14/2002	10/14/2002	0		OTH	PVT		NONE	NONE			1						1	Heart rate increased; Nausea; Pruritus	FLU3~EVANS VACCINES~E31902HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0191733	10/23/2002	TX	68.0	68		F	10/13/2002	Redness and swelling at injection site with area feeling hot to touch.									U	10/12/2002	10/13/2002	1		UNK	PVT		None				1						1	Feeling hot; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U0877AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191734	10/23/2002	IN	72.0	72		M	10/17/2002	Pt developed edema from shoulder to elbow, erythema, soreness, had difficult sleeping that night. Instructed to apply cold compresses (swelling lasted 2 days).									Y	10/09/2002	10/09/2002	0	NONE	PUB	PUB	BP meds, Lanoxin, Jacerone, Coumadin	NONE	HTN, atrial fib			1						1	Injection site erythema; Injection site oedema; Injection site pain; Insomnia	FLU3~SANOFI PASTEUR~U0912AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0165M~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0191735	10/23/2002	AL	7.0	7		F	10/17/2002	Mom presented to office within 24 hrs post Pneumovax and Flu vaccine injections with c/o pain redness and slight swelling to Rt upper arm. Upon examination MD found fine morbelli form rash around pneumovax injection site with redness and tenderness. Pt tx with Claritan 10mg and Children's Tylenol. No acute distress noted.				Y					Y	10/15/2002	10/16/2002	1	NONE	PVT	PUB	NONE	URI	S/P cochlear implant/deafness			1						1	Injection site erythema; Injection site oedema; Injection site pain; Rash morbilliform	FLU3~SANOFI PASTEUR~U0918AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0996L~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0191736	10/23/2002	CO	53.0	53		F	10/17/2002	3-4 hours post vaccine noticed small red welt on right arm by morning the raised area was gone but redness had spread across upper arm and was hot to touch. Went to urgent care and received IV antibiotics x2 doses. Redness not spreading.				Y					Y	10/16/2002	10/16/2002	0		OTH	PVT	None	None	None			1						1	Feeling hot; Rash erythematous; Urticaria	FLU3~SANOFI PASTEUR~U0968AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191737	10/23/2002	GA	68.0	68		F	10/15/2002	Vertigo. Flu shot received.									N	10/03/2002	10/03/2002	0		UNK	UNK						1						1	Vertigo	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0191738	10/23/2002	NY	21.0	21		F	10/21/2002	Itchy bumpy rash all over chest and back.									Y	10/19/2002	10/20/2002	1		UNK	UNK						1						1	Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0191739	10/23/2002	TN		78		F	10/21/2002	Per patient, could not breathe, tongue had swollen up; went to ER. The discharge summary states angioneurotic edema.				Y					Y	10/16/2002	10/16/2002	0		OTH	OTH	Mycoloq; Dyazide; Medrol Dose pack; Butalbital		Osterarthrtiis, peripheral neuropathy, migraine			1						1	Angioneurotic oedema; Dyspnoea; Tongue oedema	FLU3~SANOFI PASTEUR~U0875AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191740	10/23/2002	AZ	50.0	50		M	10/21/2002	Hours after injection, developed red skin rash on both forearms and face (? related to sun exposure?). No redness at injection site. Advised oral Benadryl. Next am, took Benadryl, began itching, scratchy throat. Seen in ER. Given IV's, Cortisone, Hydroxizine, Cinetadine.				Y					Y	10/18/2002	10/18/2002	0	UNK	OTH	PVT	Lisonopril	NONE	NONE			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U0922AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191776	10/23/2002	IN	65.0	65		M	03/14/2002	It was reported that 65 year old male patient received a Fluzone SV ' 01- 02 vaccination on 10/26/01 at 5:00 pm administration in his left deltoid. Twelve hours following the injection, the patient awakened with severe itching and was covered with large hives/red rash-similar to erythema multiform. Patient was seen in the emergency room. Treatment required of kenalog injections, oral steroids, H1 & H2 blockers, racemic epinephrine treatment. Symptoms continue to persist.  From additional correspondence received on 03/11/02, it was reported: Patient is currently well. He did require an addition to the previous treatment documented, additional oral steroids and H1 & H2 Blockers for approximately 10 days following the reaction.				Y					Y	10/26/2001	10/27/2001	1	|CBC-WBC, Neutrophil 90.8,Absolute neutrophil 12.7H	PVT	PVT	Lopid, Coumadin, Lipitor, Timolol, Cardura, ASA, vitamin E, MVI, Vitamin C, Dulcolax		Hx: Aortic Valve replacement, Lateral Sclerosis, Hyperlipidemia		U200101291	1						1	Hypersensitivity; Rash erythematous; Urticaria	FLU3~SANOFI PASTEUR~UO575AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191780	10/23/2002	IN	61.0	61		F	03/08/2002	It was reported that a 61 year old female patient received a Fluzone SV '2001-'2002 vaccination on 10/25/01. Reportedly, 10/26/01, the patient experienced hives on her chest, shoulders, back , waist and hip area. Patient was treated in ER (at an undisclosed hospital) and prescribed Medrol pack and Benadryl for itching. Patient has a history of pulmonary fibrosis.  Reportedly, the patient experienced flu last week (Feb 2000 exact date not specified) during that time, began breaking out in hives again and put on the Medrol pack again.  patient states sbe had received flu vaccinations before.				Y					U	10/25/2001	10/26/2001	1		UNK	UNK			Patient has a hx of pulmonary fibrosis.		U2000200153	1						1	Influenza; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~UO590AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191781	10/23/2002	TX				F	03/01/2002	From mailed correspondence received at a manufacturer. on 02/21/02, it was reported by a physician that a female patient (age not specified) received a Fluzone vaccination in 2000. date not specified. Reportedly, the patient developed a Bell's palsy two months after (receipt) of the flu vaccine on two occasions. She does have other neurological findings, with a peripheral neuropathy as well, but the first episodes occurred in 2000 and came two months after having received the flu vaccine. She skipped the flu vaccine last year, and then took it flu vaccine this year, and two months later developed Bell's palsy. Further information is requested.									U					UNK	UNK			HX of Bell's Palsy past a flu vaccine in 2000, two months after  receiving vaccine.	Facial Paralysis~Influenza (Seasonal) (Fluzone)~~0.00~In Patient	U2000200156	1						1	Facial palsy; Neuropathy	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191782	10/23/2002	CA	70.0			F		From telephone contact with patient's daughter, it was stated that a 70 year old female patient received a Fluzone Sv '00-'01 vaccinatiuon on 11/09/00. Reportedly, the patient developed pain at the injection site, duration time not specified. Patient also experienced flu like syndrome altered voice, coughing, chest pain, shortness of breath. Later three symptoms persist. No confirmed diagnosis after numerous tests conducted07/13/2001.									N	11/09/2000			Numerous test confirmed-no confirmed diagnosis	UNK	UNK					U2000100870	1						1	Influenza; Injection site pain	FLU3~SANOFI PASTEUR~U0409AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191783	10/23/2002	CA	66.0	66		F	08/02/2001	From telephone contact with reporting physician, it was stated that 66 year old female patient received a Fluzone SV '00 - '01 vaccination on 12/08/00. On 12/20/00, the patient developed redness around the eyes that progressed into a bilateral asymmetrical rash/papular eruption of the extremities, hairline, neckline and scalp. The doctor, who considers the condition as chronic, performed a biopsy.									U	12/07/2000	12/20/2000	13		UNK	UNK					U200100913	1						1	Rash maculo-papular	FLU3~SANOFI PASTEUR~UO446AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191785	10/23/2002	KY				U	11/28/2001	It was reported that a patient (1of 6) received a Fluzone SV '01-02 vaccination, Lot Number UO590AA administered IM on 09/26/01.  Reportedly, the patient developed a local reaction consisting of pain, redness and warmth at the injection site.  Patient was treated symptomatically and the symptoms resolved. Linked cases U2001-01195, U2001-01196, U2001-01197, U2001-01198 & U2001-01199.				Y					Y	09/26/2001				UNK	UNK					U200101025	1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~UO599AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191786	10/23/2002	CA	30.0			F	11/29/2001	It was reported that a 30 year old female patient received aFluzone SV '01 -'02 vaccination, lot UO588AA, date of administration not specified. Sometimes after the vaccination, the patient developed a very sore shoulders on same side as injection with swelling and redness				Y					U					UNK	UNK					U200101031	1						1	Oedema peripheral; Pain; Rash	FLU3~SANOFI PASTEUR~UO588AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191787	10/23/2002	MO	45.0	45		F	11/29/2001	It was reported that a 45 year old female patient received a Fluzone SV '01 -02 vaccination, administered on 10/01/01. Approximately 15 minutes after injection the patient stood up complained of left jaw pain, was unable to speak without slurring and passed out. She was transferred to ER; all test results were normal. Patient was discharged to home, Patient recovered. from this experience.				Y					Y	10/01/2001	10/01/2001	0	All test were normal.	UNK	UNK					U2000101035	1						1	Dysarthria; Pain in jaw; Syncope	FLU3~SANOFI PASTEUR~UO678AB~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191788	10/23/2002	OH	22.0	22		F	12/04/2001	It was reported that a doctor administered a 0.5cc Fluzone SV '01-'02 vaccination, lot# U0600AA in the left deltoid of her 22 year old MA on 1/05/01. Within 10 minutes, the patient felt tightness in her left deltoid. A half-hour later, the patient developed numbness and tingling in her left hand. Further information is requested.									U	10/05/2001	10/05/2001	0		PVT	UNK	Depo, Provera, Zoloft				U200101042	1						1	Injection site pain; Paraesthesia; Peripheral vascular disorder	FLU3~SANOFI PASTEUR~UO600AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191789	10/23/2002	TX	30.0			M	11/30/2001	It was reported that an adult male patient received a Fluzone SV vaccination lot UO677AA administered in his right deltoid, date of vaccination not specified. Within minutes of receiving Fluzone, the patient expressed feeling tightness in his chest with itching sensation over his body. Within 45 minutes, he had numbers in hands and feet. Hives broke out over chest area than extremities. Treatment of 50mg Benadryl was given. Followed up with primary care physician who prescribed Benadryl 50 mg every 4 hours. Patient denied being allergic to eggs.				Y					U					UNK	UNK					U200101049	1						1	Chest pain; Paraesthesia; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~UO677AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191790	10/23/2002	TX	40.0	40		F	12/04/2001	It was reported that a 40 year old  female patient received a Fluzone SV '01-'02 vaccination on 10/11/01 administered in her right arm. Within 45 minutes of administration, the patient experienced severe pain in her right shoulder and neck. Warm packs and Tylenol were used  as treatment. Further information is requested.									U	10/11/2001	10/11/2001	0		UNK	UNK					U20010150	1						1	Abdominal pain upper; Neck pain	FLU3~SANOFI PASTEUR~UO677AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191791	10/23/2002	NJ	38.0	38		F	12/04/2001	It was reported that a 38 year old female patient received a Fluzone SV '01-'02 vaccination administered on 10/01/01.  On 10/06/01, the patient went to an Er with complaints of joints pain, body aches and a fever of 100.6 F patient was diagnosed with viral syndrome, nausea and vomiting, she was discharged from the HR with medications (specifies not provided). On 10/10/01, the patient returned to the ER with complaints of fever temp 97 F, headache, nausea, weakness, dizziness and nosebleed, she was diagnosed with serum sickness possible labyrinthitis. Patient was discharged from ER. Symptoms are unresolved and the patient is to follow up with her family physician.				Y					U	10/01/2001	10/06/2001	5		UNK	UNK					U200101051	1						1	Arthralgia; Asthenia; Dizziness; Epistaxis; Headache; Myalgia; Nausea; Pyrexia; Serum sickness; Vomiting	FLU3~SANOFI PASTEUR~UO591CA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191792	10/23/2002	TX	68.0	67		F	12/04/2001	It was reported that a 68 year old female patient received a Fluzone SV '01 -'02 vaccination, lot #UO677AA in her right deltoid on 08/11/01. Approximately thirty minutes, later she came back to the clinic with severe right shoulder pain radiating to her elbow. The RN recommended a warm pack and Tylenol. Further information is requested.									U	08/11/2001	08/11/2001	0		UNK	UNK					U2001-00152	1						1	Abdominal pain upper	FLU3~SANOFI PASTEUR~UO677AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191793	10/23/2002	MT	50.0	50		F	12/05/2001	It was reported that a 50 year old female patient received a Fluzone SV '01-'02 vaccination administered on 10/11/01. The next day, the patient contacted the physician's office to report she was experiencing severe stomach cramping. Further information requested.									U	10/11/2001	10/12/2001	1		UNK	UNK					U200101053	1						1	Abdominal pain	FLU3~SANOFI PASTEUR~UO588AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191794	10/23/2002	CA				U	12/04/2001	it was reported that a patient ( 1 of 6) received a Fluzone SV '01-02 vaccination (administration date  and site information was not provided). Sometimes after vaccination, (exact date not specified) the patient developed a local reaction at the injection site. Further information is requested. Linked cases: U2001-01225, U32001-01226, U2001227, U200101228 & U200101229									U					UNK	UNK					U200101055	1						1	Injection site reaction	FLU3~SANOFI PASTEUR~UO601AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191795	10/23/2002	IN	52.0	51		F	12/18/2001	It was reported that a 52 year old female patient received a Fluzone SV '01-'02 vaccination lot #UO682AA was administered on 10/16/01 in the left deltoid. On 10/17/2001, the patient experienced a local reaction of redness, swelling, knot formation and soreness in the lymph nodes under the left arm. Physician evaluation was obtained and no therapy prescribed.				Y					U	10/16/2001	10/17/2001	1		UNK	UNK					u200101060	1						1	Injection site erythema; Injection site mass; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~UO682AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191796	10/23/2002	IN				F	12/18/2001	It was reported that a female patient (1 of 4) was vaccinated with Fluzone SV '01 -'02 vaccine, lot number UO682AA on 10/16/2001. Reportedly, the a patient developed a local reaction of redness and swelling at the injection site. Patient evaluated by a physician and no therapy was prescribed. The case is linked with reports U2001-01278, U200101279 & U2001-01280.				Y					U	10/16/2001				UNK	UNK					U2000101061	1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~UO682AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191797	10/23/2002	PA	48.0	48		F	12/19/2001	It was repported that a 48 year old female patient received a Fluzone SV '01 -'02 vaccination administered on 10/19/01. Sometimes after the vaccinations (date not specified), the patient developed flu-like symptoms, HA, muscle aches, malaise and itching all over. Patient took Benadryl and feel better now.									Y	10/19/2001				UNK	UNK					U200101070	1						1	Headache; Influenza; Malaise; Myalgia; Pruritus	FLU3~SANOFI PASTEUR~UO669AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191798	10/23/2002	LA	36.0	36		F	12/21/2001	From correspondence received on 10/25/01, it was reported that a 36 year old female received a Fluzone SV '01 -'02 vaccination administered 10/22/01. Approximately 8-10 hours after vaccination, the patient developed a headache, nausea, myalgia, lips very dry and mild diarrhea, temperature 97.7 deg F.  These symptoms resolved 24 hours later except for mild headache.									Y	10/23/2001				UNK	UNK					U200101078	1						1	Diarrhoea; Dry mouth; Headache; Myalgia; Nausea	FLU3~SANOFI PASTEUR~UO672AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191799	10/23/2002	MA	16.0	16		F	12/21/2001	From telephone call received on 1/25/01, it was reported that a 16 year female patient received  a Fluzone SV '01-'02 vaccination administration on 10/17/01. four days later, it was reported the patient became pale, sweaty, and experienced nausea and body aches. The patient had been seen in physician's office on 10/16/01 and was diagnosed with viral pharyngitis. Reportedly, the symptoms resolved.				Y					Y	10/17/2001	10/21/2001	4		UNK	UNK					U200101079	1						1	Hyperhidrosis; Nausea; Pain; Pallor; Pharyngitis; Viral infection	FLU3~SANOFI PASTEUR~UO571AD~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191800	10/23/2002		77.0	77		F	12/21/2001	From correspondence received on 10/26/01, it was reported that a 77 year old female patient received a Fluzone SV '01-'02 vaccination on 10/19/01. 12-16 hours later the patient developed generalized hives and felt tightness in her throat. Treated with over the counter Benadryl and symptoms resolved.				Y					Y	10/19/2001	10/20/2001	1		UNK	UNK					U200101085	1						1	Pharyngitis; Urticaria	FLU3~SANOFI PASTEUR~UO590AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191801	10/23/2002		49.0	49		F	12/21/2001	From correspondence received on 10/26/01,it was reported that a 49 year old female patient received a Fluzone vaccination on 10/18/01. The patient stated bad smelling odor at the injection site - no odor detected by physician.				Y					U	10/18/2001				UNK	UNK					U200101086	1						1	Injection site reaction; Skin odour abnormal	FLU3~SANOFI PASTEUR~Uo592AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191802	10/23/2002	NY	55.0	55		F	12/26/2001	From correspondence received on 10/29/01, it was reported that a 55 year old female patient received a Fluzone SV '01-'02 vaccination administered on 10/25/01. On Saturday, 10/27/01, the patient developed generalized, itchy rash. She was seen in physician's office today (10/29/01).				Y					U	10/25/2001	10/27/2001	2		UNK	UNK					U200101089	1						1	Rash pruritic	FLU3~SANOFI PASTEUR~UO685AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191803	10/23/2002	IL	57.0	57		F	04/01/2002	It was reported that a patient received a Fluzone vaccination, Lot # UO593AA, date not specified. Reportedly, the patient developed a local reaction. Reportedly 14 other people also developed with local reactions after receipt of a Fluzone vaccination. From additional correspondence received on  03/28/01, it was reported that the patient was 57 year old female that received a Fluzone SV'01-'02 vaccination on 10/26/02 and developed a local reaction within two hours after administration. Additional vaccination was given was also provided. This case is linked to reports U2002-00237 and U2002-00238.									U	10/26/2001	10/26/2001	0	NONE	OTH	OTH					U200101092	1						1	Injection site reaction	FLU3~SANOFI PASTEUR~U0593AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191804	10/23/2002		45.0	45		F	12/26/2001	It was responded that a 45 year old female born 09/27/56 received a Fluzone injection administered IM in the deltoid on 10/30/. On 10/31/01, she complained of hot, painful, swollen arm at injection site, and that Tylenol was not helping. Today 11/01/01, patient went home from job ill with achiness, fatigue and congestion.									U	10/30/2001	10/31/2001	1		UNK	UNK					U200101105	1						1	Asthenia; Injection site pain; Injection site swelling; Injection site warmth; Rhinitis	FLU3~SANOFI PASTEUR~UO671BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191805	10/23/2002	NY	5.0	6		M	12/26/2001	From telephone call received on 11/02/01, it was reported that a 6 year old male patient received a Fluzone SV '01 -'02 vaccination administered on 10/29/2001. Twenty-four hours after vaccination, the patient developed a local reaction 3' in diameter at the injection site that was red and hot to the touch. Reportedly the reaction resolved and the patient recovered.									Y	10/29/2001	10/30/2001	1		UNK	UNK					U200101108	1						1	Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U0594AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191806	10/23/2002	NE	9.0	9		M	12/16/2001	from correspondence received on 11/02/01, it was reported that a 9 yer old patient received a Fluzone SV '01-'02 vaccination administrated on 10/22/01. Twenty-four hours later, the patient reportedly experienced a large local reaction-Treated symptomatically-resolved.									Y	10/22/2001	10/23/2001	1		UNK	UNK					U200101109	1						1	Injection site reaction	FLU3~SANOFI PASTEUR~UO594AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191807	10/23/2002		76.0	76		F	12/26/2001	It was reported that a 76 year old female patient received a Fluzone SV '01-'02 vaccination administered on 10/24/01. Within 24 hours, the patient develops shortness of breath, wheezing, achiness, a temperature (not specified). Patient reported these events on 11/03/01 on her routine visit. Th symptoms completely resolved and the patient recovered.									Y	10/24/2001	10/25/2001	1		UNK	UNK					U200101112	1						1	Asthenia; Dyspnoea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U0671DA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191808	10/23/2002	MD	23.0	23		F	12/26/2001	It was reported 11/05/01 that Fluzone was administered 11/01/01. Patient developed shortness of breath, diaphoresis, throat tightness and fainted, 10-15 minutes post vaccination. Patient was evaluated in an emergency department and treated with IV Benadryl. Symptoms resolved and patient was discharged. Patient is a known asthmatic and is on bronchodialtors as needed.				Y						11/01/2001	11/01/2001	0		UNK	UNK			Asthma, Allergies to pet dander, hayfever and mice, Patient is a known asthmatic and is on bronchodialtors as needed.		U200101113	1						1	Dizziness; Dyspnoea; Hyperhidrosis; Laryngospasm; Syncope	FLU3~SANOFI PASTEUR~UO694AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191809	10/23/2002	AR	30.0	30		M	12/26/2001	From correspondence received on 11/06/01, it was reported that a 30 year old male patient received a Fluzone SV '01-'02 vaccination administered on 11/04/01. Reportedly, the patient developed a raised red area 3 inches across at the injection site. Patient was seen in clinic.				Y					U	11/04/2001	11/04/2001	0		UNK	UNK					U200101120	1						1	Rash erythematous	FLU3~SANOFI PASTEUR~U0670AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191810	10/23/2002		19.0	19		M	12/26/2001	From correspondence received on 11/07/01, it was reported that a 19 year old patient had Fluzone SV '01-'02 administered on 11/05/01 in the afternoon at the college health center. That night, the patient stated he had severe chills, sweats, dizziness, and thinks he fainted or fell onto bed. He also developed body aches, felt very weak and tired. Patient felt okay in the morning but still was a little weak and tired.									U	11/05/2001	11/05/2001	0		UNK	UNK					U200101123	1						1	Asthenia; Chills; Dizziness; Hyperhidrosis; Pain	FLU3~SANOFI PASTEUR~UO590AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191811	10/23/2002	SD	24.0	23		M	12/26/2001	From correspondence received on 11/07/01, it was reported that a 24 year  old male patient a Fluzone SV '01-01 vaccination administered on 11/05/01 at 1 pm. Twenty-one days later at approximately 6 pm, he developed excessive achiness in joints and long muscles, and nausea. Patient was seen in student health office, vital signs were stable.				Y					N	11/05/2001	11/26/2001	21		UNK	UNK					U2000101126	1						1	Nausea; Pain	FLU3~SANOFI PASTEUR~UO590AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191812	10/23/2002	IN	43.0	43		F	12/26/2001	From correspondence received on 11/08/01, it was reported that a 43 year old femalepatient receiveda Fluzone SV '01-'02 vaccination administered IM in her left deltoid to 11/07/01.reportedly that same day the patient developed larangitis, shortness of breath and soreness in the back of her neck. the patient has not been evaluated by a physician. Past mediucal history - asthma, Medications-allegra and Previcid.				Y					U	11/07/2001	11/07/2001	0		UNK	UNK	Allegra and Previcid		Asthma		U200101127	1						1	Dyspnoea; Laryngitis; Neck pain	FLU3~SANOFI PASTEUR~U0594AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191813	10/23/2002	IA				U	12/26/2001	From correspondence received on 11/08/01, it was reported that Fluzone SV '01-'02 vaccine are administered to two patients (no identifiers provided) administered on 11/05/01 in am. Reportedly, the patients developed gastrointestinal cramping and diarrhea in afternoon. Completely resolved.									Y	11/05/2001	11/05/2001	0		UNK	UNK					U200101128	1						1	Abdominal pain; Diarrhoea	FLU3~SANOFI PASTEUR~U0681AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191814	10/23/2002	MD	48.0	48		F	11/12/2001	It was reported that a 48 year old female patient received a Fluzone SV '01-'02 vaccination administered on 10/11/01. Two hours a after the vaccination, she developed a reddened area at the injection site. The next day, she developed a reddened area on her neck  and now has an area on her face (the size of a dime). The patient was seen by her family physician and a dermatologist. The dermatologist prescribed the patient Triamcinolone acetonide 1% cream. The symptoms are unresolved.									N	10/11/2001	10/11/2001	0		UNK	UNK					U200101130	1						1	Injection site reaction; Rash	FLU3~SANOFI PASTEUR~UO669AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191815	10/23/2002	FL	44.0			F	03/08/2002	It was reported that a 44 year old female patient received a Fluzone SV '01-'02 vaccination administered in left deltoid. The patient reported 11/07/01, she developed swollen lymph nodes that became painful. A physician evaluated patient and it was felt that the patient had lymphadenopathy with possible lymphadenitis. No treatment prescribed resolved.				Y					Y	11/05/2001	11/07/2001	2		UNK	UNK			Past Medical History-pre cancerous lesions of the left breast.		U200101132	1						1	Lymphadenitis; Lymphadenopathy; Pain	FLU3~SANOFI PASTEUR~UO671EA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191816	10/23/2002	IA	37.0	36		F	11/12/2001	It was reported that a 37 year old female patient was vaccinated 11/05/01 with Fluzone SV'01 -'02 , lot number UO681AA. On 11/08/01, the patient called health care facility to report that she had body aches, headaches and a temperature of 99.5 F-100 F. Patient was not evaluated by a physician.									U	11/05/2001	11/08/2001	3		UNK	UNK					U2000101134	1						1	Headache; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~UO681AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191817	10/23/2002		54.0	54		F	12/26/2001	From telephone call received on 11/12/01, it was reported Fluzone was administered on 11/07/01. Two hours after vaccination patient developed generalized. Patient was seen by physician 11/09/01 and treated with Benadryl and Prednisone.				Y					N	11/07/2001	11/07/2001	0		UNK	UNK					U200101136	1						1	Urticaria	FLU3~SANOFI PASTEUR~UO691AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191818	10/23/2002		61.0	61		F	12/26/2001	from correspondence received on 11/12/01m it was reported that a 61 year old female patient received a Fluzone SV '01-'02 vaccination administered on 10/18/01 in Savannah, Ga while traveling to Florida. the patient developed a rash at the injection site the same day. The next day developed hives - one at a time over her body-the size of a grapefruit. She was seen in ER and treated with cortisone injection and oral medications -still unresolved.				Y					N	10/18/2001	10/18/2001	0		UNK	UNK					U200101137	1						1	Pain; Urticaria	FLU3~SANOFI PASTEUR~UO596BA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191819	10/23/2002	AL	50.0	50		F	12/26/2001	From correspondence received on 11/12/01, it was reported that a 50 year female patient received a Fluzone SV '01-'02 vaccination on Friday 11/02/01. Over the weekend, the injection site(right deltoid) became red, swollen and she developed muscle tremors and a low grade fever. She saw the doctor , Nov 8th. She was put on an anti-inflammatory and antihistamine which have helped. Today when nurse called her, she still has muscle tremors.				Y					N	11/02/2001	11/04/2001	2		UNK	UNK					U200101138	1						1	Injection site erythema; Injection site swelling; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U0696BA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191820	10/23/2002	KY	83.0	83		F	03/08/2002	It was reported that an 83 year old female patient received a Fluzone SV '01-'02 vaccination, given IM in the left deltoid and a Pneumococcal vaccination given IM in the right deltoid on 11/02/01. Reportedly, on 11/03/01,the patient developed a band rash around her left arm that was red and hot to the touch. The patient reportedly recovered from this experience.									Y	11/02/2001	11/03/2001	1		PVT	PVT		NONE	DVT recurrent right leg		U200101139	1						1	Injection site erythema; Injection site warmth; Rash	FLU3~SANOFI PASTEUR~UO694AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191821	10/23/2002	TX	50.0	50		F	12/26/2001	From phone call received on 11/12/01, it was reported that a patient received  Fluzone vaccination on 11/10/01. Patient had a local reaction consisting of red area the size of quarter which was warm to touch. Patient also complained of palpitations for 5 minutes (palpitations began approximately 10 minutes after vaccination. No further information.									U	11/10/2001	11/10/2001	0		UNK	UNK					U200101140	1						1	Injection site erythema; Injection site warmth; Palpitations	FLU3~SANOFI PASTEUR~UO685AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191823	10/23/2002	PA	48.0	48		M	12/26/2001	It was reported that a 48 year old male patient received his Fluzone vaccination in his left deltoid on 11/06/01. pain in left auxilla and chest started right away and has lasted 5-6 days. Patient has swelling of the left auxillar and chest area as well as his left hand. Patient has been diagnosed with carpel tunnel in his left hand so the numbness and tingling may be the result of that. Further information is requested.									U	11/16/2001	11/16/2001	0		UNK	UNK					U200101149	1						1	Chest pain; Oedema; Pruritus	FLU3~SANOFI PASTEUR~UO687AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191824	10/23/2002	WI	64.0	65		F	12/27/2001	From correspondence received on 11/13/01, it was reported that a 64 year old female patient received a Fluzone SV '01 - '02 lot # UO602BA and a Pneumovax lot 470-393 vaccination administered on 10/30/01 in the right deltoid. On 10/31/01, the patient called and reported she developed an orange size area of redness and swelling 2 inches below injections. On 11/01/01, patient was seen in physician's office the reaction was irregular and the red area was the size of a softball (4' X 5.25).				Y					U	10/30/2001	10/31/2001	1		UNK	UNK					U200101153	1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~UO602BA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~470393~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0191825	10/23/2002	WI	65.0			M	12/27/2001	From correspondence received on 11/14/01, it was reported that a 65 year old male patient received a Fluzone SV '01 -'01 vaccination on 10/29/01. Approximately 3 days post vaccination, the patient experienced severe myalgia in neck, shoulder and pelvic region ,mainly in proximal muscles of the body. Had difficult getting up in morning due to stiffness. After he got up and moved around an hour or two later would be more functional but some discomfort was still present. Symptoms persisting until the present with little improvement in the neck muscles at this time.									N	10/29/2001	11/01/2001	3		UNK	UNK					U200101157	1						1	Hypertonia; Myalgia	FLU3~SANOFI PASTEUR~UO574AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191826	10/23/2002		26.0	26		M	12/27/2001	From correspondence received on 11/14/01, it was reported that a 26 year old patient received a Fluzone SV '01 -'02 vaccination on 11/14/01 at 1:30 pm. By 2 pm, he had developed urticaria. Antihbistimine relieved. Patient has many allergies, one allergy to horses.									U	11/14/2001	11/14/2001	0		UNK	UNK			Patient has many allergies, one allergy to horses		U200101158	1						1	Urticaria	FLU3~SANOFI PASTEUR~U0675AB~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191827	10/23/2002	FL	55.0	55		F	12/26/2001	It was report that a 55 year old female Speech Language Pathologist working at a hospital received her Fluzone SV ;01-'02 injection on Thursday 11/01/01 at 3pm. That evening, she noticed red small dots on her abdomen which spread thru out the evening to her torso (belly, chest, back, neck, both arms, especially the anticubital area of inner arms and groin area). On Friday 11/02/01, the rash looked more like hives. On Saturday, 11/03/01, patient also felt nauseous. She denies raking anything for it. By Sunday 11/04/01, rash, hives were not as bad. Monday 11/0501 there was still a trace but fading to dots again and itchy. On Tuesday11/06/01, skiin was clear, rash gone.									Y	11/01/2001	11/01/2001	0		UNK	UNK					U200101159	1						1	Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191828	10/23/2002	MD	48.0			F	12/26/2001	It was reported that a 48 year old female received a Fluzone SV '01-'02 vaccination, lot # U0694Aa on 11/06/01 at 1;15 pm. By 3pm, she reported a rapid heart beat, heaviness & tightness in mid-chest and wheezing She is not, nor ever has been asthmatic. This lasted 45 minutes until 3:45 pm. Patient refused any follow-up. She said that the room where it was administered smelled moldy and this might have triggered a reaction.									Y	11/06/2001	11/06/2001	0		UNK	UNK					U200101160	1						1	Asthma; Chest pain; Tachycardia	FLU3~SANOFI PASTEUR~uo964aa~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191829	10/23/2002	MH	44.0			M	12/26/2001	It was reported that a 44 year old male patient received a Fluzone SV vaccination Lot # UO694AA administered on 11/05/01. Twelve hours later reported the patient developed chills, shaking, aching and sweating. Patient did not return to office for further evaluation.									U	11/05/2001	11/05/2001	0		UNK	UNK					U200101161	1						1	Chills; Hyperhidrosis; Pain; Tremor	FLU3~SANOFI PASTEUR~UO694AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191831	10/23/2002		40.0	40		F	12/26/2001	It was reported that a 40 year old female patient was administered a Fluzone SV '01-'02 vaccination, Lot U0862AA in 11/01 at work. Later that evening she reported a burning swollen arm and developed a rash. She reports using Benadryl, which alleviated it somewhat.  Nurse reported she has allergies to sulfur penicillin and milk products. When the nurse saw her, she stated that the rash was gone and all she observed was little scratch marks where patients was probably scratching She gave her cortisone cream.				Y					U	11/01/2001	11/01/2001	0		UNK	UNK			Allergies to sulfur, penicillin and milk products		U200101165	1						1	Oedema peripheral; Rash; Skin burning sensation	FLU3~SANOFI PASTEUR~UO682AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191832	10/23/2002					F	01/03/2002	It was reported by the patient that she received a Fluzone SV '01-'02 vaccination in her right deltoid and a pneumococcol administered in her left deltoid. The patient stated she felt hoarseness, nausea, cold and chills & ran low grade temp overnight of 100.5 F.  Her left arm was as she described paralyzed for 3 days afterwards.									U					UNK	UNK					U200101173	1						1	Dysphonia; Nausea; Paralysis; Pyrexia	FLU3~SANOFI PASTEUR~~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0191833	10/23/2002	MN				F	12/26/2001	It was reported that an adult female patient received a Fluzone SV '01 - '02 vaccination. Lot # UO693AA on 11/11/01. Patient received vaccinet at place of employment by outside health clinic. Patient notified clinic on 11/13/01 that she developed hoarseness that resolved by 11/13/01. Patient not evaluated by physician. No known treatment.									Y	11/11/2001				UNK	UNK					U200101174	1						1	Laryngitis	FLU3~SANOFI PASTEUR~Uo693AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191834	10/23/2002		46.0	46		F	12/28/2001	From telephone call received, it was reported : Patient received Fluzone vaccine administered 10/21/01 in her left deltoid. Within 2-3 days, congestion started. She reported large clumps of mucus. In the middle of the night, she couldn't breathe. Her doctor saw her to evaluate and put her on Clariton 10mg daily and Flonase once a day. Albuterol Inhaler PRN. Her doctor told her she had an allergic reaction to something in the Fluzone. Then she saw on TV last evening that this year's flu was causing 'Flu-Like symptom and feels that this exacctly what happened to her. One month later she is still experiencing these problems.				Y					N	10/22/2001	10/25/2001	3		UNK	UNK					U200101177	1						1	Dyspnoea; Hypersensitivity; Rhinitis	FLU3~SANOFI PASTEUR~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191835	10/23/2002	NY	43.0	43		F	12/27/2001	It was reported that a 43 year old female patient received a Fluzone SV '01-'02 vaccination on 11/13/01 administered in her right deltoid. The next day, patient developed generalized edema. Weight increased  11 pounds. Patient was given Lassix with Potassium 20mg PO for 5 days. Patient left for Florida next day so no follow up.				Y					U	11/13/2001	11/14/2001	1		UNK	UNK					U200101178	1						1	Generalised oedema; Weight increased	FLU3~SANOFI PASTEUR~UO711AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191836	10/23/2002					M	12/28/2001	From telephone contact received on 11/26/01, it was reported by the patient that he was immunized with Fluzone on 11/09/01 and on 11/10/01 developed these spots that started on his hands and spread to other areas of his body. He was evaluated by his physician who informed him what he had was folloculitis-bacterial infection of the skin and was not related to the flu vaccine. The patient feels it was triggered by the flu vaccine. Patient also stated he swims and uses a hot tub in the YMCA which is a public facility. These spots lasted for one week. A dermatologist was not consulted.				Y					U	11/09/2001	11/10/2001	1		UNK	UNK					U200101186	1						1	Rash	FLU3~SANOFI PASTEUR~UO677AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191837	10/23/2002	PA	25.0	25		F	12/26/2001	It was reported that a 25 year old female patient was immunized 11/25/01 at 1:30 pm with a Fluzone SV '01-'02 vaccine. That same day, the patient developed hives on her legs at 3:30 pm. She was seen in employee health clinic and treated with Benadryl.  Patient was seen on Nov 27th by medical manger-hives still present. First time receiving flu vaccine for the patient. Prior allergies reaction to Augmentin.									U	11/26/2001	11/26/2001	0		UNK	UNK			Prior allergies reaction to Augmentin		U200101187	1						1	Urticaria	FLU3~SANOFI PASTEUR~UO951DA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191838	10/23/2002	PA	24.0			F	12/26/2001	It was reported that a 24 year old female patient received a dose of Fluzone SV '01-'02 administered IM on 11/26/01 in her left deltoid by a doctor. The night after dose was received, the patient experienced pain and redness at the administration site, fever and was unable to sleep due to the pain. Physician stated that on 11/27/01 a massive warm lump was present at the site of injection or just slightly above injection site. Patient took Tylenol for the pain. Patient stated that she was not able to use her left arm the day following vaccination. Used warm compresses for pain. Physician will be following up with patient to see when symptoms resolve.				Y					U	11/26/2001	11/27/2001	1		UNK	UNK					U200101189	1						1	Injection site mass; Injection site pain; Injection site reaction; Pyrexia	FLU3~SANOFI PASTEUR~U0678CA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191839	10/23/2002	KY				U	11/28/2001	It was reported that a patient  (2 of 6) received a Fluzone SV '01-'02 vaccination, Lot number UO590AA administrated IM on 09/26/01. Reportedly, the patient developed a local reaction  consisting of pain, redness and warmth at the injection site. Patient was treated symptomatically and the symptoms resolved. Linked cases U2001-01025, U2001-01196, U2001-01197, U200101198 & U2001-01199.				Y					Y	09/26/2001				UNK	UNK					U200101195	1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~UO590AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191840	10/23/2002	KY				U	11/28/2001	It was reported that a patient (3 of 6) received a Fluzone SV 01'02 vaccination. Lot number U0590AA administered IM on 09/26/2001. Reportedly, the patient developed a local reaction consisting of pain, redness and warmth at the injection site. Patient was treated symptomatically and the symptoms resolved. Linked cases: U2001-01025, U2001-01195, U2001-01197 & U2001-01199.				Y					Y	09/26/2001				UNK	UNK					U200101196	1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~UO590AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191841	10/23/2002	KY				U	11/28/2001	It was reported that a patient (4 of 6) received a Fluzone SV '01-'02 vaccination, Lot number UO590AA administered IM on 09/26/01. Reportedly, the patient developed a local reaction consisting of pain, redness and warmth at the injection site. Patient was treated symptomatically and symptoms resolved. Linked cases: U2001-01025, U2001-01195, U2001-01196, U2001-01198 & U2001-01199.				Y					Y	09/26/2001				UNK	UNK					U200101197	1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~UO590AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191842	10/23/2002	KY				U	11/28/2001	It was reported that a patient (5 of 6) received a Fluzone SV '01-'02 vaccination. Lot number UO590AA administered IM on 09/26/2001. Reportedly, the patient developed a local reaction consisting of pain, redness and warmth at the injection site. Patient was treated symptomatically and the symptoms resolved. Linked cases:U2001-01025, U2001-00195, U2001-96, U2001-01197 & U2001-01199.									Y	09/26/2001				UNK	UNK					U200101198	1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~UO590AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191843	10/23/2002	KY				U	11/28/2001	It was reported that a patient (6 of 6) received a Fluzone SV '01-'02 vaccination, Lot number U)590AA administered IM on 09/26/01. Reportedly, the patient developed a local reaction consisting of pain, redness and warmth at the injection site. Patient was treated symptomatically and the symptoms resolved. Linked cases: U2001-01025, U2001-01195, U2001-01196, U2001-01197 & U2001-01198.				Y					Y	09/26/2001				UNK	UNK					U200101199	1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~UO590AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191844	10/23/2002	NJ	43.0	43		F	12/28/2001	From correspondence received on 11/28/01, it was reported that a 43 year old female patient received a Fluzone SV '01-'02 vaccination administered approx. one month ago (Oct,2001). Within 48 hours, the patient developed a rash and pruritus on her back and spread over entire body. patient was seen by two dermatologists- unresolved.									N	10/01/2001	10/03/2001	2		UNK	UNK					U200101201	1						1	Rash pruritic	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191845	10/23/2002					F	12/28/2001	It was reported 11/29/01 that Fluzone  (lot # Uo692AA) was administered on 11/27/01. On 11/29/01, recepient reported to school nurse with a local reaction of redness and swelling. Patient advised to see her physician for follow up 11/29/01. School nurse instructed to take either ibuprofen or acetomenophen for any side effects. PMH-sulfa allergies.				Y					U	11/27/2001	11/29/2001	2		UNK	UNK					U200101202	1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~UO692AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191846	10/23/2002	CA	46.0			U	11/29/2001	It was reported that a 46 year old patient received a Fluzone SV '01-'02 vaccination, lot UO588AA, date of administration not specified. Sometime after the vaccination, the patient developed a very sore shoulder on same side as injection with swelling and redness at the shoulder area but no reaction at the injection site. Patient was seen in physician's office.				Y					U					UNK	UNK					U200101204	1						1	Oedema peripheral; Pain; Rash	FLU3~SANOFI PASTEUR~UO588AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191847	10/23/2002	CA	29.0	29		F	11/29/2001	It was reported that a 29 year old female patient received a Fluzone SV '01-'02 vaccination, lot UO601AA administered IM in the deltoid on 10/01/01 at 1:00 pm. Reportedly on 10/02/01 at 10:00 am, the patient experienced pain, redness, heat, swelling and a delayed rash at the injection site. Reportedly, the patient recovered from this experienced.									Y	10/01/2001	10/02/2001	1	NONE	PVT	PVT		NONE	NKA		U200101208	1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site rash; Injection site warmth	FLU3~SANOFI PASTEUR~UO601AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191848	10/23/2002		30.0			F	12/28/2001	From telephone contact received on 11/29/01, it was reported that an employee developed a red papular rash the same day she received a vaccination of Fluzone. Patient not evaluated by a physician. Self medicated with Benadryl 25 mg as directed Rash resolved in 24 hours.									Y					UNK	UNK					U200101213	1						1	Rash papular	FLU3~SANOFI PASTEUR~UO696BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191849	10/23/2002	IL	53.0	53		F	12/27/2001	It was reported by the patient she was administered Fluzone SV '01-'02 on 11/28/01. Later that evening, she stated she felt very agitated and sleepless. Her upper arm at the injection site became very red, hot and swollen. She reports taking Ibuprofen and applying cold packs. The area included 3 above elbow to 1 below shoulder. The site is down to 3 x 3 now. General Malaise and bone ache was also part of the symptoms.									U	11/28/2001	11/28/2001	0		UNK	UNK					U200101217	1						1	Agitation; Arthralgia; Injection site erythema; Injection site swelling; Injection site warmth; Insomnia; Malaise	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191850	10/23/2002	MI	50.0			M	12/28/2001	From correspondence received on 12/03/01, it was reported that a 50 year old male patient received a Fluzone SV '01-'02 vaccination administered on 10/10/01 That same day the patient developed pain at the injection site. X-rays negative - pain unresolved.									N	10/10/2001	10/10/2001	0	X-rays - negative	UNK	UNK					U200101219	1						1	Injection site pain	FLU3~SANOFI PASTEUR~UO713AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191851	10/23/2002		55.0	56		F	12/28/2001	From a telephone call received on 12/03/01, it was reported that a patient was administered Fluzone on 11/05/01 in her left deltoid. The next morning, patient awoke with bilateral conjuctivitis. The eye doctor dismissed viral conjuctivitis. She also had facial flushing, swelling and itching of face and neck. The doctor prescribed Allegra and Opcona eye drops for eye allergy. All symptoms resolved within 72 hours.				Y					Y	11/05/2001	11/06/2001	1		UNK	UNK					U200101220	1						1	Conjunctivitis; Face oedema; Pruritus; Vasodilatation	FLU3~SANOFI PASTEUR~UO701AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191852	10/23/2002			54		F	12/28/2001	From telephone call recived on 12/04/02, it was reported that on 11/08/01, Fluzone vaccine was administered and patient developed swelling at injection site the same day. The next day, the injection site was grossly swollen.  Patient  was seen by physician, who ordered warm soaks, Symptoms completly resolved.				Y					Y	11/08/2001	11/08/2001	0		UNK	UNK					U200101222	1						1	Injection site swelling	FLU3~SANOFI PASTEUR~UO6969AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191853	10/23/2002	IN	48.0	48		F	12/28/2001	From correspondence received at manufacturer on 12/4/01 it was reported that a 48 year old female patient received a Fluzone SV 2001-2002 vaccination administered on 11/20/01. Within 6-9 hours that patient developed aching joints and dull ache at the injection site--unresolved.									N	11/20/2001	11/20/2001	0		UNK	UNK					U200101224	1						1	Arthralgia; Injection site pain; Pain	FLU3~SANOFI PASTEUR~U0687AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191854	10/23/2002	CA				U	12/04/2001	It was reported that a patient (2 of 6) received a Fluzone SV 2001/2001 vaccination (administration date and site was not provided). Sometime after the vaccination (exact date not specified), the patient developed a local reaction at the injection site. Further information is requested. Linked cases: U200101055, U200101226, U200101227, U200101228 and U200101229.									U					UNK	UNK					U200101225	1						1	Injection site reaction	FLU3~SANOFI PASTEUR~U0601AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191855	10/23/2002	CA				U	12/04/2001	It was reported that a patient (3 of 6) received a Fluzone SV 2001-2002 vaccination (administration date and site information was not provided). Sometime after the vaccination (exact date not specified), the patient developed a local reaction at the injection site. Further information is requested. Linked cases : U200101055, U200101225, U200101227, U200101228, and U200101229.									U					UNK	UNK					U200101226	1						1	Injection site reaction	FLU3~SANOFI PASTEUR~U0601AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191856	10/23/2002	CA				U	12/04/2001	It was reported that a patient (4 of 6) received a Fluzone SV 2001-2002 vaccination (administration date and site information was not provided). Sometime after the vaccination (exact date not specified) the patient developed a local reaction at the injection site. Further information is requested. Linked cases: U200101055, U200101225, U200101226, U200101228, and U200101229.									U					UNK	UNK					U200101227	1						1	Injection site reaction	FLU3~SANOFI PASTEUR~U0601AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191857	10/23/2002	CA				U	12/04/2001	It was reported that a patient (5 of 6) received a Fluzone SV 2001-2002 vaccination (administration date and site information was not provided). Sometime after the vaccination (exact date not specified) the patient developed a local reaction at the injection site. Further information is requested. Linked cases: U200101055, U200101225, U200101226, U200101227 and U200101229.									U					UNK	UNK					U200101228	1						1	Injection site reaction	FLU3~SANOFI PASTEUR~U0601AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191858	10/23/2002	CA				U	12/04/2001	It was reported that a patient (6 of 6) received a Fluzone SV 2001-2002 vaccination (administration date and site information was not provided). Sometime after the vaccination (exact date not specified) the patient developed a local reaction at the injection site. Further information is requested. Linked cases: U200101055, U200101225, U200101226, U200101227 and U200101228.									U					UNK	UNK					U200101229	1						1	Injection site reaction	FLU3~SANOFI PASTEUR~U0601AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191859	10/23/2002	NE	26.0	26		F	12/28/2001	From correspondence received at manufacturer on 12/4/01 it was reported that a 26 year old female patient received a Fluzone SV 2001-2002 vaccinated administered on 11/27/01. The next morning the patient noticed red bumps from neck to tops of ankles which itched and burned. Patient taking over the counter medication--unresolved.									N	11/27/2001	11/28/2001	1		UNK	UNK					U200101230	1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0706AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191860	10/23/2002					M	12/28/2001	Patient administered Fluzone in right deltoid on 11/13/01. 36 to 48 hours began with severe pruritis, small raised lesions after itching began. No red, just raised began at the site on right arm but developed and spread distally. Then erupted in various locations such as right leg to cover 80% of his body. It is worse at night and still persists. Doctor has tried antihistimines. Solumedrol dose pack. Going to see dermatologist on 12/10.				Y					N	11/13/2001	11/15/2001	2		UNK	UNK					U200101233	1						1	Injection site swelling; Pruritus; Skin ulcer	FLU3~SANOFI PASTEUR~U0683AE~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191861	10/23/2002		33.0	34		F	12/28/2001	From correspondence received at manufacturer on 12/5/01 it was reported that a 33 year old female patient received a Fluzone SV 2001-2002 vaccination administered on 12/5/01. Patient developed a local reaction 2 hours after vaccination--3.5cm red swollen area.									U	12/05/2001	12/05/2001	0		UNK	UNK					U200101234	1						1	Injection site erythema; Injection site reaction; Injection site swelling	FLU3~SANOFI PASTEUR~U0714AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191862	10/23/2002					F	12/28/2001	RN reported second hand that an adult female patient, had received Fluzone through RN's company who give public flu shots. It was reported by the patient's husband that she had a seizure during the night just 4 days after receiving Fluzone. Their doctor could find nothing wrong.				Y					U					UNK	UNK					U200101235	1						1	Convulsion	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191863	10/23/2002	PA	55.0			F	12/28/2001	It was reported that a 55 year old female patient received a dose of Fluzone administered in her right deltoid, lot # U0729AA, the date of administration is not known at this time. Within 5 minutes of receiving vaccination, the patient became flushed and had increased heart rate. Benadryl was administered and within a couple of hours symptoms subsided.									Y					UNK	UNK					U200101260	1						1	Flushing; Heart rate increased; Vasodilatation	FLU3~SANOFI PASTEUR~U0729AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191864	10/23/2002	FL	45.0	45		F	12/28/2001	It was reported that a 45 year old patient received a Fluzone SV 2001-2002 vaccination on 10/30/01 at approximately 4:30 PM. At 1:30 AM the next morning the patient awoke with nausea, vomiting, diarrhea and feeling shaky inside. She also has bouts of vertigo. The patient was evaluated by her physician and received an IV for dehydration. The patient 3 years ago was evaluated for dizziness and headaches with vertigo. She does have something in the pons of her brain and has a history of febrile convulsions from the age of 5. She also experienced bouts of vertigo after other vaccinations and has prescription medication for that.				Y					U	10/30/2001	10/31/2001	1		UNK	UNK			Dizziness and headaches with vertigo		U200101263	1						1	Diarrhoea; Nausea; Vertigo; Vomiting	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191865	10/23/2002	IN	45.0	45		F	12/28/2001	It was reported that a 45 year old female patient received a Fluzone SV 2001-2002 vaccination, administered on 11/19/01. The patient developed pain in upper and lower arm and shoulder area one week after vaccination. These symptoms are currently unresolved.									N	11/19/2001	11/26/2001	7		UNK	UNK					U200101265	1						1	Pain	FLU3~SANOFI PASTEUR~U0687AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191866	10/23/2002	MI	47.0	47		F	12/28/2001	It was reported that a 47 year old female patient received a Fluzone SV 2001-2002 vaccination, administered on 12/12/01. The patient experienced itching immediately and redness (8cm) at the injection site.									U	12/12/2001	12/12/2001	0		UNK	UNK					U200101270	1						1	Injection site erythema; Injection site hypersensitivity; Pruritus	FLU3~SANOFI PASTEUR~0708AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191867	10/23/2002	TN	73.0	72		M	12/28/2001	It was reported that a 73 year old male patient received a Fluzone SV 2001/2002 vaccination, administered on 10/8/01. On 10/24/01 the patient was seen in physician's office with a cystic like area at the injection site 1.3x2 area. This reaction is currently unresolved.									N	10/08/2001				UNK	UNK					U200101271	1						1	Injection site cyst	FLU3~SANOFI PASTEUR~U0593AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191868	10/23/2002	IN				F	12/18/2001	It was reported that a female patient (2 of 4) was vaccinated with Fluzone SV 2001-2002 vaccine, lot number U0682AA on 10/16/01. Reportedly the patient developed a local reaction of redness and swelling at the injection site. Patient was evaluated by a physician and no therapy was prescribed. This case is linked with reports U200101061, U200101279 and U200101280.				Y					U	10/16/2001				UNK	UNK					U200101278	1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U0682AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191869	10/23/2002	IN				F	12/18/2001	It was reported that a female patient (3 of 4) was vaccinated with Fluzone SV 2001-2002 vaccine, lot number U0682AA on 10/16/01. Reportedly the patient developed a local reaction of redness and swelling at the injection site. Patient was evaluated by a physician and no therapy was prescribed. This case is linked with reports U200101061, U200101278 and U200101280.				Y					U	10/16/2001				UNK	UNK						1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U0682AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191870	10/23/2002	IN				F	12/18/2001	It was reported that a female patient (4 of 4) was vaccinated with Fluzone SV 2001-2002 vaccine, lot number U0682AA on 10/16/2001. Reportedly the patient developed a local reaction of redness and swelling at the injection site. Patient was evaluated by a physician and no therapy was prescribed. This case is linked to reports U200101061, U200101278 and U200101279.				Y					U	10/16/2001				UNK	UNK					U200101280	1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U0682AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191871	10/23/2002	ND	40.0	40		F	12/18/2001	It was reported that a 40 year old female patient received Fluzone SV 2001-2002 vaccinated on 10/10/01 at 12 PM. Reportedly within one hour of vaccination the patient developed pruritus and hives that lasted for 48 hours. Treated with Prednisone, Triamunolone cream and Atartar. The patient recovered from this experienced.									Y	10/10/2001	10/10/2001	0		OTH	OTH		None	Possible Sulfa--skin reaction		U200101282	1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0672AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191874	10/23/2002	MN	54.0	53		F	12/27/2001	It was reported that a 54 year old female received a Fluzone SV 2000-2001 vaccination on 11/08/00 administered IM in her left deltoid. The patient claiming vaccine was administered incorrectly. Nurse stated feels like I hit something soft and spongy. The patient developed immediate pain in the anterior deltoid. Diagnosed with Bursitis, physical therapy was used. Doctor feels the vaccine caused the adverse event not the nurses technique. The patient has recovered approximately 90% per doctor.									Y	11/08/2000	11/08/2000	0	MRI - tendonitis posterior cuff.	PVT	UNK					U200101326	1						1	Bursitis; Injection site pain; Tendonitis	FLU3~SANOFI PASTEUR~U0398AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191875	10/23/2002	IL	58.0	58		M	05/24/2002	From mailed correspondence received on 03/11/02 regarding a 59 year old received Influenza (Fluzone SV '01-'02) vaccine on 10/18/01 at 4 pm, it was reported by the patient that on 12/24/01 he developed rapid onset flu symptoms consisted of 103.5 degree F fever, chills, sweats. Patient did not see a physician. Strain of Flu was not confirmed by culture. These symptoms are currently unresolved. Patient receive vaccine at local Osco drug store. Additional information received on 03/11/02 from mailed correspondence patient reported that he developed flu symptoms on 12/2/01. He developed fever (103 degrees F orally), chills, sweat, body aches, light cough and no nasal discharge. Symptoms lasted above 4 days easing. Flu not confirmed by culture. Patient recovered. The case is closed.									Y	10/18/2001	12/24/2001	67		OTH	PVT	zocor		Non-smoker, Does not work in high risk environment, Has been taking flu vaccine for7 years.		U200101327	1						1	Cough; Hyperhidrosis; Pain; Pyrexia	FLU3~SANOFI PASTEUR~VOB81AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191876	10/23/2002	MO				F	01/16/2002	It was reported that an adult female patient, date of birth unknown, received a Fluzone SV 2001-2002 vaccination, lot # U0705AA on 12/10/01 at the health department. For the past 3 weeks she has experienced severe pain and stiffness in the arm of injection from injection site to her hand. She is going to be evaluated by her doctor.									U	12/10/2001				UNK	UNK					U200101346	1						1	Injection site pain; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U0705AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191877	10/23/2002	GA				M	01/14/2002	It was reported by the patient that he an adult male patient, received a Fluzone SV 2001/2002 vaccination administered in 11/01. Approximately one week later the patient developed a rough rash inside his mouth and lower lip, patient also developed urethritis--these symptoms are currently unresolved.									N	11/01/2001	11/08/2001	7		UNK	UNK					U20020006	1						1	Rash; Urethritis	FLU3~SANOFI PASTEUR~U0706AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191878	10/23/2002	WA	49.0	49		F	01/14/2002	It was reported that a 49 year old female patient received a Fluzone SV 2001-2002 vaccination, administered on 12/26/01. That evening the patient developed pain in her deltoid shoulder area. Patient has limited range of motion due to the pain--unresolved. (Not sure which lot # - U0711AA or U0592AA exp 6/20/02).									N	12/26/2001	12/26/2001	0		UNK	UNK					U200200007	1						1	Joint range of motion decreased; Shoulder pain	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191879	10/23/2002	VA	44.0	43		F	02/07/2002	From telephone call received at manufacturer on 1/8/02 it was reported that a 44 year old female patient received a Fluzone SV 01-02 vaccination administered on 10/30/01. Somtime after the vaccination (date not specified) the patient developed pain that continues in deltoid area; interferes with range of motion. This event is unresolved.									N	10/30/2001				UNK	UNK					U200200010	1						1	Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~U0677AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191880	10/23/2002	IL				F	01/14/2002	It was reported that a female patient received a dose of Fluzone SV 01-02 vaccine on 11/20/01 administered in her left deltoid, lot # U0671BA. Sometime after the vaccination (date not specified) the patient developed tingling in her left arm. Symptoms persisted for approximately 2 weeks, described as a painful tingling, Motrin was prescribed. Currently the tingling is still present, appears to be positional, comes and goes, somewhat alleviated by movement, more noticeable if leaning on arm for period of time.									U	11/20/2001				OTH	OTH					U200200012	1						1	Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U0671BA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191881	10/23/2002	IL	49.0	49		F	01/14/2002	It was reported that by the patient that she , a 49 year old female patient, received a Fluzone SV '01-'02 vaccination on 12/03/ at 1:50 pm. Within 24 hours after vaccination the patient developed a metal taste in her mouth. Reportedly, the symptoms have resolved and the patient recovered from this experience.									Y	12/03/2001	12/03/2001	0		OTH	PVT	Glucotrol, Zestril, Lipiotor, Claritin, Mobic	NONE	Allergy to Penicillin & Iodine, Ulcerative Colitis, High blood Pressure, Diabetes		U200200032	1						1	Dysgeusia	FLU3~SANOFI PASTEUR~UO700AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191882	10/23/2002	WV	45.0			F	02/07/2002	From telephone call received at manufacturer on 1/22/02 it was reported that a 45 year old female patient received a Fluzone SV 01-02 vaccination, lot # U0710AA on 11/16/01. On 11/18/01 she experienced muscular pain from the shoulder to the wrist. The patient was treated symptomatically by the physician with Lortab, Tylenol, Medrol pack, NSAIDS and cortisone. Symptoms persist. The physician plans on prescribing tests to rule out other causes. The patient required no hospitalization nor ER visits.				Y					N	11/16/2001	11/18/2001	2		UNK	UNK					U200200040	1						1	Myalgia	FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191884	10/23/2002	IA	68.0	68		F	02/06/2002	From correspondence received at manufacturer on 1/17/02, it was reported that a 68 year old female patient received a Fluzone SV 01-02 vaccination administered on 11/29/01. Painful at the time of injection. Immediately the patient lost range of motion of the right arm, unable to move arm towards back and unhook bra or fasten a seatbelt. She can't reach side (opposite), can raise arm straight up. Experiences pain in arm at right in muscle between shoulder and elbow. Physician thought injection hit a nerve. Treatment of using test exercises and prescribed VIOXX for 19 days. Flu shot was given high in deltoid, one finger below bone. Above treatments made no difference.				Y					N	11/29/2001	11/29/2001	0		PUB	PUB		None	NKDA		U200200074	1						1	Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~U0710AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191901	10/23/2002	WA	81.0	81		M	05/24/2002	From telephone contact received on 2/12/02 at manufacturer, it was reported that an 81 year old male received Influenza (Fluzone SV 2001-2002) vaccine on 11/12/01. Patient reported that he went to the ER on 11/16/01 with a fever of 105, red face and neck, fatigue and dry cough. Patient was instructed to force fluids, take Tylenol and to follow up with his family physician. Patient returned to his physician on 11/28/01 and informed him of the ER visit. Symptoms resolved.				Y					Y	11/12/2001	11/16/2001	4		UNK	UNK	Cozar, Daily Multivitamin, Atenolol, Prilosec, VIOXX		CAD, Heart Palpitations, Hypertension, Arthritis, GERD		U200200115	1						1	Cough; Fatigue; Flushing; Pyrexia	FLU3~SANOFI PASTEUR~U0676AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191902	10/23/2002	FL	69.0	69		F	03/12/2002	From telephone correspondence received on 12/26/02, it was reported that 69 year old female patient received a Fluzone SV '01-'02 vaccination administered on 10/08/01. The patient developed generalized hives about 1week later. She was seen in physician's office 3 weeks later, treatment of Benadryl and Prednisone was prescribed. Patient was seen by physician on 11/27/01, symptoms still persists she was prescribed Atarax as treatment. The patient was seen by allergist in December, 2001 then seem by a dermatologist in January and February 2002. Intermittent hives still persist.				Y					N	10/08/2001	10/15/2001	7		UNK	UNK					U200200134	1						1	Urticaria	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191903	10/23/2002	CA				M	05/24/2002	From telephone contact received at manufacturer on 4/1/02, it was reported that a male received Fluzone on 1/3/02. patient experienced flu-like symptoms six hours later. Next, he developed muscle pains occurring in different parts of his body making walking and sleeping painful. He is working with a rheumatologist. Diclofenine 75mg BID is not effective so far. He was then injected with Cortizone in the gluteals with no relief.				Y					N	01/03/2002				OTH	OTH					U200200234	1						1	Influenza like illness; Insomnia; Myalgia	FLU3~SANOFI PASTEUR~U0699AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191904	10/23/2002	IL				F	04/01/2002	From correspondence received on 03/28/01, it was reported that a female patient received a Fluzone SV '01-'02 vaccination on 10/26/2001. Reportedly, that same day, the patient developed a 1.5 cm local reaction of redness, soreness and a fever. Reportedly, the patient recoved from this experience. This report is linked with case # U200101092 and U200200328									Y	10/26/2001	10/26/2001	0	NONE	OTH	OTH		NONE	NONE		U200200237	1						1	Injection site erythema; Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~UO593AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191907	10/23/2002	IA	60.0	60		M	05/24/2002	From telephone contact received on 04/22/02, it was reported that a 60 year old male received Fluzone vaccine on 12/04/01. Patient felt pain at injection after injection. Patient seen in doctor's office on 03/26/02. Symptoms unresolved.				Y					N	12/04/2001	12/04/2001	0		OTH	OTH					U200200303	1						1	Injection site pain	FLU3~SANOFI PASTEUR~U0172AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191908	10/23/2002	IL	58.0	58		F	10/23/2002	Hives on chest near breast bone and on right shoulder.  First appeared two days following shot and continue presently.  Have taken antihistimine										10/18/2002	10/20/2002	2		UNK	UNK		None				1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0191909	10/23/2002	MD	37.0	37		F	10/23/2002	Immediate reaction, within 15 min of vaccination = dizzy, very dry mouth, slight swelling of throat, altered attention level Delayed reaction, starting approximately 3 hr after vaccination = soreness at site of vaccination (upper R arm) extending downward to fingers, and radiating to back and chest; alternating chills and sweating; dizzy and weak feeling; nausea 12-36 hr post vaccination = continued dizzy and nausea; tingling and numbness of R arm; back pain and minor chest pain. Missed work the day after vaccination, able to report to work the following day. Did not seek medical attention as of this writing.									N	10/21/2002	10/21/2002	0		UNK	UNK	Celebrex, Plaquenil, Protonix, Provigil, Prednisone, albuterol inhaler, Pulmicort inhaler, triphasic birth control pills	None	Asthma, SLE	To Hep B/tetanus~Vaccine not specified (no brand name)~1~36.40~In Patient		1						1	Asthenia; Back pain; Chest pain; Chills; Dizziness; Dry mouth; Hyperhidrosis; Hypoaesthesia; Injection site pain; Nausea; Paraesthesia; Pharyngeal oedema	FLU3~SANOFI PASTEUR~U0913AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191910	10/23/2002	OH	60.0	60		F	10/23/2002	weak, bodyaches										10/21/2002				UNK	UNK						1						1	Asthenia; Pain	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0191523	10/24/2002	CT	75.0	75		F	11/06/2002	Information has been received from a health care professional concerning a 74 year old female was vaccinated with a dose of Fluzone (lot number U0911BA) on 10/11/02. The next day, patient noticed a small rash on her abdomen. On 10/13/02, the sunburn like rash extended from the back of her neck to the buttocks and from both of her shoulders down to the wrists. She was presented to hospital and hospitalized for 3 days with the treatment of antibiotics and Benadryl. The rash resolved. Patient also received a dose of pneumonia vaccine. Per reporter, this information has been reported verbally tot he FDA. Follow up correspondence received on 11/4/02 confirmed that the pt's date of birth is 8/11/27. The pt's age is 75 years, not 74 years as previously reported. This case is closed. Follow up on 11/18/2003: From additional correspondence received on 08/27/2003, the route and site information for both products were provided, as well as the lot number and manufacturer of the pneumococcal vaccine.  The responsible physician information was also provided.  No further information is anticipated, this case is considered closed.  From additional information received on 11/07/2003 from another manufacturer (Merck), no new medical information was provided.  The other manufacturer reference number is WAES0309USA00237.  No further information is anticipated, this case is considered closed.					Y	3			Y	10/11/2002	10/12/2002	1		OTH	OTH					U200200837	1						2	Headache; Hypersensitivity; Pruritus; Rash; Rash erythematous; Rash	FLU3~SANOFI PASTEUR~U0911BA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0445M~2~~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U0911BA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0191918	10/24/2002	CA	48.0	48		M	10/17/2002	10/17 Weakness progressing to complete flacidity in legs. Diagnosis - acute transverse myelitis. No CNS involvement. 10/22 Some recovery noted, not fully recovered yet. Pt began it experience same back pain/ weakness within 2-3 days at injection (oct 3-4th) Discahrged from hospital 11/29/2002.					Y	5			U	10/01/2002			MRI, Spinal	OTH	OTH	None	None	None			1						1	Asthenia; Pain	FLU3~SANOFI PASTEUR~U0968AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0191919	10/24/2002		45.0	44		F		A report was received a health professional on 10/15/02, concerning a 45year old female patient who experienced no cartoid pulse, stopped breathing and collapsed, immediately after receiving Fluvirin on 10/15/2002. The patient had no relevant medical history and was not taking any other medications. She had receive the influenza vaccine in the past  ( Fall 2001) but could not confirm whether or not it had been Fluvirin. On 10/15/02, the patient received Fluvirin. Immediately after, the patient complained that she felt very warm. The patient's face then turned ashen and she slumped over. The nurse administering the Fluvirin could not detect a cartoid pulse and noted that the patient had stopped breathing for approximately one minute. At that time, emergency paramedics were called. the nurse was initiating CPR when the patient roused and asked what was going on. She was then taken by the paramedics to hospital for observation. The patient recovered without sequalae on the same day. The patient was described as being healthy and an endurance runner, and had a baseline blood pressure of 127/80 with a pulse of 48. The reporter has assessed the relationship of Fluvirine to the event as probable. The follow up states apical rate dropped to 42, and the vaccinee was transported to hospital by ambulance. The vaccinee was admitted to a coronary care unti under the care of a cardiologist for 1.5 days. An EKG, MRI, and EEG were performed. The diagnosis was of severe vasodilation leading to shock resulting in lack of oxygen to the brain, which resulted in the vaccinee's heart stopping. At the time of the report the vaccinee had recovered. There was insufficient info to determine the reporter's causality assessment.			Y		Y				Y	10/15/2002	10/15/2002	0		UNK	UNK	Concomitant drugs not used.				PJP200200492	1						1	Apnoea; Feeling hot; Pallor; Pulse absent; Syncope	FLU3~EVANS VACCINES~E30412GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0191920	10/24/2002	TN		46		F	10/07/2002	Dose given 10/4/02 about 17:00. On 10/05/02, awoke with local reaction at site of injection approximately 2 inches in diameter. Extreme soreness in shoulder muscle treated with Acetaminophen 1000mg. 17:00-18:00--Nausea, diarrhea 3 times, excessive sweating followed by chills and rigors. Rigors continued until about 20:00 with treatment of hot bath, acetaminophen 1000mg, and bed rest. Excessive sweating continued until 03:00. Local reaction at site with swelling approximately 5 inches in diameter continues as of reporting time with shoulder soreness and tenderness at site of injection. No fever reported at any time.										10/04/2002	10/05/2002	1	None	UNK	UNK	Synthyroid; Heredia; E.C ASA; Wellbutrin		Allergies to iodine, betadine, cephalosporin, Obesity, hypothyroidism			1						1	Chills; Diarrhoea; Hyperhidrosis; Injection site reaction; Injection site swelling; Nausea; Shoulder pain	FLU3~SANOFI PASTEUR~U0872AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191922	10/24/2002	OR	89.0	89		F	10/18/2002	Red, swollen, hot to touch band across width of left arm above elbow approximately 4 below where vaccine was given.									U	10/08/2002	10/10/2002	2		OTH	UNK			Masectomy-right side			1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U0875AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1352L~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0191923	10/24/2002	OR	78.0	78		M	10/18/2002	Red, swollen, hot 4 band across width of arm (right) above elbow. Approximately 3 below hwere Pneumovax was given. 1 week later, it is gone.									Y	10/08/2002	10/10/2002	2		OTH	UNK			Stitches in left arm day before, vaccine given.			1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U0875Aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1352L~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0191924	10/24/2002		34.0			M		A report was received from a health professional on 10/15/02, concerning a 34 year old male patient who experienced pinching chest pain and neck pain after receiving Fluvirin on 10/14/02. the patient had been in excellent health and has no known drug allergies. At 09:15 on 10/14/02, the patient experienced pinching chest pain and neck pain, after receiving the Fluvirin vaccine 15 minutes earlier. The patient complained of severe pinching  chest pain on the upper left chest and severe pain on the left side of the neck. The patient had a weak pulse and was admitted to the ER. At the time of the ambulance arriving the patient's heart rate was 146/100. At the ER the patient was given four tablets of aspirin and one tablet of Nitroglycerin which relieved the chest discomfort. On the same day, the patient recovered and was discharged from the ER. The reporter has assessed the relationship of study medication to the event as possible.				Y						10/14/2002	10/14/2002	0		UNK	UNK					PJP200200495	1						1	Blood pressure increased; Chest pain; Neck pain	FLU3~EVANS VACCINES~E30132FA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0191925	10/24/2002	CA	64.0	64		F	10/16/2002	Hoarseness (one-day after I received the vaccine) on the 3rd day I began to take Bactrim DS because of asthma condition. One week later I am still hoarse.									U	10/09/2002	10/10/2002	1		PUB	OTH		NONE	Asthma			1						1	Condition aggravated; Dysphonia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0191927	10/24/2002	WA	14.0	14		F	10/22/2002	8 hours post inj. temp 102.6 x 3 days. Rapid pulse, fatigue, day 4 temp down 99.8 c/o extreme fatigue x 4 days. 10/21/02 saw pediatrician-no diagnosis other than let it run its course child back in school still c/o fatigue and rapid pulse. To f/u with provider within 48 hours.				Y					N	10/14/2002	10/14/2002	0	NONE	PUB	PUB	NONE	NONE	Seasonal allergies, EEs, Benzane			1						1	Fatigue; Heart rate increased; Pyrexia	FLU3~SANOFI PASTEUR~UO971AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~1353L~1~IM~RA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0191928	10/24/2002	TN	34.0	34		F	10/23/2002	Five minutes after vaccine (flu) given in L deltoid, severe pain show down from site of injection to L ring finger. Complains of severe pain, hypersensitivity, tingling and some numbness. Has seen PCP, ortho. Now pt is on Neurontin and Mohic, unable to use left arm.  As per follow up: Neurologist diagnosed of brachial neuritis . On Vioxx and Percocet. Excruciating pain, numbeness, and tingling in left side of the neck. Doing physical therapy three times a week. Could last up to one year.									N	10/02/2002	10/02/2002	0	Sed rate normal, evaluation done	PVT	OTH	Flonase nasal spray	NONE	Allergic to Toradol			1						1	Hypoaesthesia; Hypokinesia; Injection site hypersensitivity; Injection site pain; Pain; Paraesthesia; Radiculitis brachial	FLU3~EVANS VACCINES~E33362GA~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0191931	10/24/2002	MO	62.0			F	10/18/2002	Hives and wheezing. Received shot in morning; went to hospital at 12:30AM; received cortisone shot and allergy pill to take at home.				Y					Y		10/11/2002		None	PUB	OTH			Diabetes, HBP			1						1	Urticaria; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0191953	10/25/2002	PA	43.0	43		F	10/21/2002	Received vaccine Wednesday; light itchy only Thursday. Friday evening, site was hard, red, itchy and swelling 4 inches in diameter. Rx with ice. Yesterday and today, site is itchy, red, and very warm. Advised to continue to observe. No systemic symptoms reported.									Y	10/16/2002	10/18/2002	2	None	PVT	PVT	Synthroid	none	Shellfish, Iodine			1						1	Feeling hot; Injection site erythema; Injection site hypersensitivity; Injection site induration; Injection site swelling; Pruritus	FLU3~PFIZER\WYETH~4020011~UNK~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0191954	10/25/2002	FL	22.0			F	10/18/2002	Approximately one hour after vaccine administration, pt c/o numbness and tingling of R cheek and jaw along with numbness and tingling of R shoulder extending to R elbow. Symptoms disappeared post 24 hours.									Y					PVT	PVT	NONE	NONE	NONE			1						1	Hypoaesthesia; Paraesthesia	FLU3~SANOFI PASTEUR~U0878AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191955	10/25/2002	MA	43.0	43		F	10/21/2002	Received dose from pre-filled syringe provided by manufacturer. Returned to clinic site approx 20 min later, c/o pain in upper shoulder, neck area with tingling in face and jaw, side of injection. BP, HR wnl for pt. Evaluated throughout day. No resp symptoms. Status checked 10/21 resolved.									Y	10/18/2002	10/18/2002	0		PVT	PVT			Migraine			1						1	Pain; Paraesthesia	FLU3~EVANS VACCINES~E33092HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0191956	10/25/2002	NJ	49.0			F	10/19/2002	I work as a nurse. I took the annual flu shot offered by our hospital for employees. Several hours after the injection I developed some soreness to injection site and upper arm-which I expected. Later in evening as I was working in the hospital I felt my left arm going numb and some tingling. I mentioned this to other workers at the time. During the night I awakened many times due to numbness in my arm and the inability to lie on my left side due to arm pain, severe swelling of deltoid area. I went to a mirror to check on the site and the area was swollen greatly and a large-size of a Progresso soup can-reddened circular area at injection site was highly visible. My fingers went from tingling during the day t complete numbness by day's end on the 12th of October. The numbness resolved on Tuesday the 15th. I was very nervous about this, called my personal physician on Saturday morning, the MD on call returned my phone call and told me it would just resolve itself-and offered me pain killers. I told him the discomfort was NOT the problem, I just needed reassurance that my arm would be okay. He told me to keep an eye on it. I have received the flu shot other years since the age of 25 or so. I have never had any reaction before to a flu shot other than minor discomfort at injection site for a few hours Never had a bullseye mark either.									Y		10/11/2002		NONE	UNK	UNK						1						1	Discomfort; Hypoaesthesia; Injection site erythema; Injection site oedema; Injection site pain; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0191957	10/25/2002	TX	32.0	32		F	10/24/2002	Had difficulty breathing.									Y	10/23/2002	10/23/2002	0		UNK	UNK						1						1	Dyspnoea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0191958	10/25/2002	MD	33.0	33		F	10/16/2002	Patient was given flu shot at 13:58 and instructed to wait 20 minutes in the clinic rest area in case of any reactions. Patient came back at 14:15 with complaints of itching on the face, around the nose and at vaccine site. Vital signs checked: temperature 98.9; pulse 63; respiratory rate 20; BP 109/53. Benadryl 50mg PO given. No respiratory distress. Patient told to wait 30 minutes and was discharged.									Y	10/16/2002	10/16/2002	0	None	OTH	OTH	Depeprovera	None	None			1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~4020024~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0191959	10/25/2002	MD	60.0	60		M	10/18/2002	Left arm red, grapefruit size area, slight itching, not warm to touch. Treatment with cool compresses, Benadryl and Tylenol.									U	10/16/2002	10/17/2002	1		PVT	UNK			Diabetes			1						1	Erythema; Pruritus	FLU3~PFIZER\WYETH~4020024~7+~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0541M~2~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0191960	10/25/2002	MD	62.0	62		F	10/18/2002	Left arm red; lemon size. Few other areas. Slight warmth to touch. Patient booked with doctor.									U	10/16/2002	10/18/2002	2		UNK	UNK						1						1	Erythema; Feeling hot	FLU3~PFIZER\WYETH~4020024~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0191961	10/25/2002	SC	83.0	86		F	10/23/2002	10/22/02 Received pneumococcal vaccine right deltoid. Came in on 10/23/02 right arm swollen from shoulder down to elbow. Red and warm to touch. Had fever last night. Husband stated all this started last night. Gave Zyrtec in office. Took Tylenol last night. Prescription written for antibiotic, Zyrtec and Tylenol.									Y	10/22/2002	10/22/2002	0	None	PVT	PVT	Zyrtec, Verapan, Digotin, Coumadin	None	Sulfa, CMA, Irritable bowel syndrome			1						1	Feeling hot; Swelling	FLU3~SANOFI PASTEUR~U0880AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1050L~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0191981	10/25/2002	NY	71.0			F		A report was received from a health professional on 10/15/02, concerning a 71 year old female patient who experienced injection site redness, infection and fever requiring medical intervention, after receiving Fluvirin on 10/8/02. On 10/11/02, the patient experienced redness at left arm, injection site and fever after receiving Fluvirin in the left arm on 10/8/02. On examination the left arm was red and swollen, with a streak running down her entire left arm. The patient had a temperature of 38.33 degrees C. The patient was treated with an unknown dose of oral ciprofloxacin and was sent home. At the time of this report the patient had not recovered. The reporter has assessed the relationship of study medication to the event as probable.				Y						10/08/2002	10/11/2002	3		UNK	UNK					PJP200200496	1						1	Injection site erythema; Injection site infection; Pyrexia; Swelling	FLU3~EVANS VACCINES~E35732HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0192034	10/25/2002	KS	62.0	62		F	10/25/2002	c/o redness and swelling in the arm she got the injection with a line going down into armpit.  Described as very tender and hurts if I reach for something.										10/23/2002	10/25/2002	2		PVT	PVT	Celebrex, Estropipate, Imitrex (PRN)	None	NKDA			1						1	Erythema; Oedema	FLU3~SANOFI PASTEUR~U0882AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0111M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192035	10/25/2002	KS	70.0	70		F	10/25/2002	Pt c/o right arm being red, swollen and painful from her shot.										10/21/2002	10/23/2002	2		PVT	PVT	Zebeta, Ambien		NIDDM, Hypertension, Hyperlipidemia			1						1	Erythema; Oedema; Pain	FLU3~SANOFI PASTEUR~U0882AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0111M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192036	10/26/2002	IL	2.0	2	.0	F	10/26/2002	Urticaria without respiratory distress within 8 hours of Fluzone vaccine.  Persisted for days. Widespread giant urticaria without joint symptoms.				Y					Y	10/21/2002	10/21/2002	0	None	PVT	UNK	None	None	None			1						1	Urticaria	FLU3~SANOFI PASTEUR~UO924FA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192038	10/27/2002	CA	66.0	66		M	10/27/2002	Mild Hives on left side of torso: 1 A.M. 10/27/02 Mild Hives on right side of torso and inside  upper arm:10:00 A.M. 10/27/02										10/26/2002	10/27/2002	1		PVT	UNK	Lipitor diovan toprol celebrex lantus ( insulin )					1						1	Urticaria	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0192039	10/27/2002	TX	34.0	34		F	10/27/2002	PATIENT EXPERIENCED VOMITING AND DIARRHEA LATER IN THE EVENING AFTER RECEIVING THE INFLUENZA VACCINE									Y	10/26/2002	10/26/2002	0		UNK	PVT						1						1	Diarrhoea; Vomiting	FLU3~SANOFI PASTEUR~U0932AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0191990	10/28/2002	ND	25.0	25		F	10/15/2002	Had a local reaction at time of immunization, i.e. hives, itching. Reported to MD and given EPI.2m1on on site and instructed patient to take Benadryl 25mg at home. Less than 24 hours later, had episode of seizure brought to clinic per ambulance and sent to hospital for follow up tests.				Y	Y	1			Y	10/09/2002	10/09/2002	0		PUB	UNK	None	None	None		ND0215	1						1	Injection site reaction; Pruritus; Urticaria	FLU3~EVANS VACCINES~E31872CA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0191991	10/28/2002	IL	14.0	14		F	10/21/2002	Patient with mild gastroenteritis including mild abdominal pain and diarrhea; received influenza vaccine 10/15. Next day, patient experienced severe abdominal pain/tenderness. Exploratory laparoscopy revealed no perforation or significant inflammation of appendix. Post laparoscopy, patient's pain resolved. Per 60 day follow up: Pt has not recovered. Pt still with ongoing abdominal pain, bloody urine, fatigue. No other additional comments.				Y	Y	2			N	10/15/2002	10/16/2002	1	Pelvic U/S - large amounts of free fluid in pertonial cavity. Appendix (removed during laparoscopy) without inflammation.	PVT	PVT	Levsin	Gastroenteritis	Irritable bowel syndrome			1						1	Abdominal pain; Blood urine; Diarrhoea; Fatigue; Gastroenteritis	FLU3~PFIZER\WYETH~4020003~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0191995	10/28/2002	TX	7.0	7		F	10/20/2002	Sore, stiff arm, knot at injection site, red and fevered. Treated with ice pack, heat and Motrin.									Y	10/09/2002	10/09/2002	0		MIL	MIL	Creon 10 and 20, ADCKS, albuterol, TOBI		Cystic fibrosis			1						1	Injection site erythema; Injection site mass; Injection site pain; Injection site warmth; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U0880AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~489470~1~~RA~PNEUMO (PREVNAR)~1	USA		Influenza
0191996	10/28/2002	MI	64.0	64		F	10/23/2002	Three days after administration of vaccine developed redness/swelling/itching which progressed from shoulder to elbow.				Y					Y	10/15/2002	10/18/2002	3	NONE	PVT	PVT		NONE	NONE			1						1	Injection site erythema; Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~EVANS VACCINES~E31882GA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~SANOFI PASTEUR~U0521AA~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0191997	10/28/2002	WV	33.0	33		F	10/22/2002	On evening of receiving flu immunization developed temporary blindness in right eye. Symptoms resolved after starting medrol pack. No symptoms by evening of 10/16/02. Developed temporary blindness in right eye after vaccine 10/01 with symptoms lasting until 6/02. Connection not linked to vaccine until pt received vaccine this year and developed blindness.				Y					Y	10/15/2002	10/15/2002	0		OTH	PVT		NONE				1						1	Blindness transient; Blindness	FLU3~SANOFI PASTEUR~U0966BA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~40966BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0191998	10/28/2002	NC	1.5	1	.5	U		Within 2 hrs of DTaP, IPV, flu vaccine child became lethargic, whiney, inconsolable with forceful episode of emesis.									Y	10/18/2002	10/18/2002	0	NONE	PVT	UNK		NONE	Asthma			1						1	Crying; Irritability; Lethargy; Vomiting	DTAP~SMITHKLINE BEECHAM~8546LA2~4~IM~LL~DTAP (INFANRIX)~1|FLU3~PFIZER\WYETH~4020022~1~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|IPV~SANOFI PASTEUR~U0907~3~SC~RL~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0191999	10/28/2002	VA	67.0	67		F		Local erythema and swelling, scattered areas of erythema and swelling on trunk and extremities.									U	10/14/2002	10/15/2002	1	NONE	PVT	PVT		NONE	Allergy to aspirin and amoxicillin			1						1	Erythema; Injection site erythema; Injection site oedema; Oedema	FLU3~EVANS VACCINES~E3352GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~445M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192000	10/28/2002	CA	5.0	5		M	10/24/2002	Bilateral deltoids and sq areas are slightly swollen, red and fine red bumps. Currently pt only c/o itching. Is walking, playing and verbalizing needs. (Currently is hungry). Also per mom no motrin given.				Y					Y	10/18/2002	10/20/2002	2		PUB	PUB	PPD	NONE				1						1	Injection site erythema; Injection site oedema; Pruritus; Rash	DTAP~SANOFI PASTEUR~U0584AA~5~IM~LA~DTAP (TRIPEDIA)~1|FLUX~UNKNOWN MANUFACTURER~U0877AA~3~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~SANOFI PASTEUR~U1428~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1215L~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0192001	10/28/2002	CA	40.0	40		F		Vaccine given at 1pm, pm started to get fatigue 1am chills, fever, malaise.									U	10/16/2002	10/16/2002	0	NONE	PUB	PVT	NONE	NONE				1						1	Chills; Fatigue; Malaise; Pyrexia	FLU3~SANOFI PASTEUR~U0926EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192002	10/28/2002	CA	61.0	61		F	10/24/2002	Sore throat. Laryngitis. Hoarsness.									N	10/22/2002	10/23/2002	1		UNK	UNK						1						1	Dysphonia; Laryngitis; Pharyngolaryngeal pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192003	10/28/2002	NC	75.0	83		M	10/18/2002	Pt received Pneumovax SQ notl arm. Sxs of red and swelling started 12 hrs post receiving injections. Pt states that redness and swelling was 2-3 width. Started antibiotics. Within 24 hrs and sxs started to improving. Pt states sxs cleared.				Y					Y	10/08/2002	10/09/2002	1	NONE	UNK	UNK	Tylenol #3, clavil 25mg #4 tabs	NONE	NONE			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U0429AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1159L~7+~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192004	10/28/2002	NC	69.0	69		F	10/18/2002	Pt states reaction started 3-4 hrs post getting injection . had itching, redness and swelling started size of orange. Then redness moved down Lt arm warm to touch. Keflex 500mg tid #21, Allegra 180mg. Sxs resolved with 6 days post injection and tx.				Y					Y	10/08/2002	10/08/2002	0		UNK	UNK	Vaseretic, Lipitor, Vioxx, Premprn	NONE	Motrin, Codeine, Advil			1						1	Injection site erythema; Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~SANOFI PASTEUR~U0929AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1159L~2~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192005	10/28/2002	NC	76.0	76		F	10/18/2002	Redness, swelling, warm to touch painful to move arm.									Y	10/10/2002	10/10/2002	0		PVT	UNK	NONE					1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U0989AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0111M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192006	10/28/2002	FL	22.0	22		M		Rash to R arm and forearm L forearm, both hands and later over face 10/23/02. Claritin-rx 10mg #10 medrol dose pack 4mg #211 tabs and Depo Medrol 80mg at 1745pm				Y					N	10/18/2002	10/23/2002	5		UNK	PVT	NONE	NONE				1						1	Rash	FLU3~SANOFI PASTEUR~U0872AB~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192007	10/28/2002	IL	54.0	54		F	10/24/2002	Pt had dizziness, paleness, diaphoresis, slight trouble breathing and weakness 3-4 hrs after receiving the flu vaccine. Went to ER treated and released same day.				Y					Y	10/23/2002	10/23/2002	0		PUB	UNK		NONE	Hypertension and hyperlipidemia			1						1	Asthenia; Dizziness; Dyspnoea; Hyperhidrosis; Pallor	FLU3~SANOFI PASTEUR~U0903AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192008	10/28/2002	MT	54.0	54		M	10/24/2002	S/S-difficulty breathing, wheezing, weakness, increase HR; diaphoresis. Symptoms started at 10pm and lasted for 6.5 hrs. 10/23/02 Lantus insulin 10ml #30 (30 days) inject 100 units at bedtime.									Y	10/23/2002	10/23/2002	0	NONE	PUB	PUB	Diphenhydramiine, Furosemide, Trazodone, Zocor, Norvasc, Prinzide, Viagra, Avandia, Avapro, comfort curve test strips, Triamcinolone, Albuterol, Clonidine, Coreg, Novolin	NONE	NONE			1						1	Asthenia; Dyspnoea; Heart rate increased; Hyperhidrosis; Wheezing	FLU3~SANOFI PASTEUR~U0871AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192009	10/28/2002	VA	42.0	42		F	10/18/2002	Left arm red/swollen evening of 10/16/02. By next day, diffuse arthralgias bilateral arms, hands, knees, hips, jaw. Not red at site of injection. No fever, rash and petiache.										10/16/2002	10/16/2002	0	Basic metabolic panel, CPK, Sediate	PVT	UNK		None	Hypertension, Eczema, Inactive asthma			1						1	Arthralgia; Erythema; Swelling	FLU3~EVANS VACCINES~E35712~4~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~SANOFI PASTEUR~U0943AA~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192028	10/28/2002	NC				F	07/31/2002	A female consumer reported that she was given influenza virus vaccine, trivalent, types A & B 2001-2002 formula. Subsequent to immunization, her arm became swollen. No further information was available at the date of this report. This report was received from manufacturer.									U				Unk	OTH	OTH	Unk	Unk	Unk		HQ3307017JUL2002	1						1	Injection site swelling	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0192029	10/28/2002	MD	26.0			F	10/16/2002	A healthcare professional reported that a 26 year old female patient received an injection of Flu Shield on an unspecified date. Approximately 12 hours after receiving the injection she developed an elevated temperature and an injection site reaction characterized by redness and swelling. The reporter indicated that the patient was treated with Tylenol and ice packs. The patient's concomitant medications include a birth control shot for contraception.									U				Unk	OTH	OTH	Unk	Unk	Unk		HQ4477102OCT2002	1						1	Injection site erythema; Injection site reaction; Injection site swelling; Pyrexia	FLU3~PFIZER\WYETH~4018041~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0192230	10/28/2002	MO	0.0			F	10/28/2002	Redness, warmth approx 3inchesx2inches below site of injection				Y					Y	10/22/2002	10/22/2002	0		PUB	UNK						1						1	Erythema; Feeling hot	FLU3~EVANS VACCINES~E35462HA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0192048	10/29/2002		45.0			F	10/25/2002	A nurse reported that a 45 year old female received an injection of influenza virus vaccine (manuf unk). Subsequently, the pt developed paralysis which lasted for three days. No further info was available at the date of this report. Paralysis is considered medically important (OMIC).									Y				UNK	OTH	OTH	UNK	UNK	Hypersensitivity NOS		HQ4680717OCT2002	1						1	Paralysis	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0192049	10/29/2002	NJ	78.0			M	10/25/2002	A healthcare professional reported that a 78 year old male, with a history of myelodysplastic syndrome received an injection of Flu Shield on an unspecified date. Concomitant therapy included Flomax, aspirin, Cardizem, Procrit, and Cipro. On 10/16/02, the pt was hospitalized with chills, fever and shortness of breath. It was later determined that the pt experienced an exacerbation of yelodysplastic syndrome. Lab test results were not provided. The pt also stated he developed renal failure. According to the pt, his attending physician felt the exacerbation of myelodysplastic syndrome may have caused renal stone (calculus renal nOS) which in turn caused hyperkalemia and renal failure. The pt's experience of renal stones and hyperkalemia leading to renal failure was considered medically important (OMIC).					Y				U		10/16/2002		UNK	OTH	OTH	ASA, Cardizem, Cipro, Flomax, Procrit	UNK	Myelodysplastic syndrome NOS		HQ4728021OCT2002	1						1	Chills; Condition aggravated; Dyspnoea; Pyrexia; Renal failure	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0192055	10/29/2002	OH	80.0	80		M	10/22/2002	Redness, warmth to arm. Levaquin 500mg IV for 3 doses.					Y	1			Y	10/16/2002	10/17/2002	1	CBC WBC 13.40	PUB	PUB	Tisin opril, Amitriptyline, Toprol, Prilosec, Claritin, Zocor, Celebrex, Ambien	NONE	Penicillin			1						1	Erythema; Feeling hot	FLU3~PFIZER\WYETH~4020003~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0675M~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0192056	10/29/2002	OH	67.0	67		M	10/22/2002	Redness and swelling of injection site. Progression of inflammation with use of antibiotics. Admitted for IV antibiotics (Zosyn).					Y	3			Y	10/16/2002	10/17/2002	1	CBC-WBC 5.80	PUB	PUB	Zocor, Priniril, ASA	NONE	NKA			1						1	Injection site erythema; Injection site inflammation; Injection site oedema	FLU3~PFIZER\WYETH~4020003~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0675M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0192058	10/29/2002	IA	52.0	51		M	10/21/2002	Told by private doctor in day prior to vaccination it was okay to get the flu vaccine. Legs weak 10/11 pm, worse 10/12-hospitalized. 10/12, couldn't walk. 10/13 Did CAT, MRS, CSF. Doctor Dx as Guillain-Barr‚ syndrome. Due to rapid onset of symptoms, doctors do not feel it's related to flu vaccine. Being treated for colon cancer. Had a virus sev. weeks earlier.  Per 60 day follow up: It is unknown if the pt has recovered.. Pt's phone is disconnected. Follow up on 6/2004: No information reported.					Y				Y	10/10/2002	10/12/2002	2	CAT, MRS, CSF	PUB	PUB	Antibiotics; Pain meds	Draining operative abscess	Being treated for colon cancer; virus			1						1	Abasia; Guillain-Barre syndrome; Muscular weakness	FLU3~SANOFI PASTEUR~U0908AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0192070	10/29/2002	MT	54.0	54		F	10/21/2002	One day post immunization, pt had nickel sized bruise at injection site on L delt. Next day developed three more slightly swollen bruises in line at slight angle down from injection site about 2 apart. Bruises resolving 10 days later. No other injuries at that time noted by pt.									Y	10/11/2002	10/12/2002	1		OTH	PVT		NONE	NONE			1						1	Contusion; Injection site oedema	FLU3~PFIZER\WYETH~4020027~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0192071	10/29/2002	GA	72.0	71		F	10/18/2002	Pt called pharmacist, evening of 10/16/02. She told her right arm was hurting and painful. Was informed her to contact her doctor. Pt went to the ER later that evening.				Y					Y	10/15/2002	10/16/2002	1		OTH	PUB						1						1	Injection site pain	FLU3~SANOFI PASTEUR~V0875AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0111M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192072	10/29/2002	VA	39.0	39		M	10/25/2002	Alleged (pt called and reported over the telephone) T 102, chills, body aches that began ~ 6hrs post vaccine was given; referred him to PCP.				Y					U	10/23/2002	10/23/2002	0	NONE	OTH	PVT		NONE	NONE			1						1	Chills; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U0922AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192073	10/29/2002	IL	69.0	69		F	10/22/2002	Pt stopped at clinic 10/22/02 14:30-states on 10/18/02 approx 20:00 L upper arm became reddened and tender. On 10/19/02 redness spread and had a lump on arm below bandaid that covered inj. site. Unable to contact MD by phone so pt went to ER 10/20/02-dx with cellulitis from Pneumovax in L deltoid. Started on Keflex. Today on exam red circle quarter size about 3/4 inferier to inj site.				Y					Y	10/18/2002	10/18/2002	0	NONE	PVT	OTH		Low back pain	Novocaine, srawberries, walnuts			1						1	Cellulitis; Injection site erythema; Injection site mass; Injection site pain; Injection site reaction	FLU3~SANOFI PASTEUR~U0908AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0210M~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192074	10/29/2002	NC	72.0	72		F	10/18/2002	Immediate redness not only at site but distally with tenderness and erythema. Dx Cephalepan 500 bid x 7 days.									U	10/16/2002	10/16/2002	0	NONE	PVT	PVT	Celebrex, Fosanox, Potassium	NONE	Pazet's disease, orteoporosis		NC02105	1						1	Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U0927AA~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1353L~2~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192075	10/29/2002	NV	51.0	50		F	10/23/2002	Localized skin reaction at injection site. Treatment Benadryl 50mg IM									Y	10/22/2002	10/23/2002	1	None	PVT	PVT		None	None			1						1	Injection site reaction	FLU3~SANOFI PASTEUR~U0968AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0675M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192076	10/29/2002	WY	28.0	28		F	10/18/2002	7cm x 4.5cm swollen, reddened area at injection site which was warm to touch. Sharp intermittent pain from R shoulder elbow to R fingers. Saw PMD morning of 10/18/02 who instructed pt to take Benadryl. Redness and swelling minimal by pm or 10/18 but pain persists.									Y	10/16/2002	10/17/2002	1	Nasal swab at PMD visit	PUB	PUB	NONE	Sore throat	PCN			1						1	Injection site erythema; Injection site oedema; Injection site warmth; Pain	FLU3~PFIZER\WYETH~4020024~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0192077	10/29/2002	NY	46.0	46		F	10/24/2002	Pt states arm got swollen and red at site of injection the day after shot. States in 2001 had slight redness at injection site.									Y	10/15/2002	10/16/2002	1	NONE	PVT	PVT	Neurontin, Zomig, Celexa, ZInderal LA, Claritin, Aciphex, Effexor, Fiorinal,	NONE	Migraines, GERD, parathyroid adenoma, L breast cancer	Redness at site~Influenza (Seasonal) (no brand name)~1~45.00~In Patient		1						1	Injection site erythema; Injection site oedema	FLU3~EVANS VACCINES~E25802KA~2~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0192078	10/29/2002	NY	39.0	39		M	10/24/2002	Increase in blood pressure and heart rate, slight shortness of breath. (Within 5 minutes of shot) (passed in about 30 minutes) Weakness and slight fever the following day.				Y					Y	10/23/2002	10/23/2002	0		UNK	PVT		NONE	Allergy to penicillin, sulfer, demerol			1						1	Asthenia; Blood pressure increased; Dyspnoea; Heart rate increased; Pyrexia	FLUX~UNKNOWN MANUFACTURER~E30122FA~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0192079	10/29/2002	GA	59.0	59		F	10/22/2002	Significant redness, swelling and fever at injection site (left shoulder/arm).				Y					Y	10/17/2002	10/17/2002	0	NONE	OTH	OTH		NONE				1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U0875AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0111M~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192080	10/29/2002	MO	0.75	0	.8	F	10/22/2002	Vomiting, lethargy, wt loss in two days, metabolic acidosis. Hospital x 24 hrs.					Y	4			Y	10/15/2002	10/17/2002	2	UTI (-), UA ph 8-0, nl CBC, serum AA organic aci-pending	PVT	PVT	NONE	Loose stools x 2	NONE			1						1	Acidosis; Lethargy; Vomiting; Weight decreased	FLU3~SANOFI PASTEUR~U0888AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0705M~3~IM~LL~HEP B (RECOMBIVAX HB)~1|IPV~SANOFI PASTEUR~W0013~3~SC~LL~POLIO VIRUS, INACT. (IPOL)~1	USA	Hospitalisation	Influenza
0192081	10/29/2002	NJ	37.0	37		M	10/21/2002	Generalized edema L arm from elbow to shoulder and torso itching, diaphoretic, no SOB. Heart 90, resp 20 B/P 142/6/. 25mg Benadryl PO, 60mg Prednisone PO.				Y					Y	10/16/2002	10/16/2002	0	NONE	PVT	PVT		NONE	Latex allergy (anaphylaxis)			1						1	Hyperhidrosis; Oedema; Pruritus	FLU3~EVANS VACCINES~E35792K~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0192082	10/29/2002	CA	68.0	68		F	10/24/2002	I was feeling relaxed and sleepy, began getting nervous, heart palpitations, unable to sleep, hallucinations during hours of 12:30 midnight and 5 am. Slightly elevated temp 2 days. Recovered 5th day.									Y	10/10/2002	10/11/2002	1		OTH	OTH	NONE	NONE	NONE			1						1	Hallucination; Insomnia; Nervousness; Palpitations; Pyrexia; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192083	10/29/2002	OH	71.0	71		M	10/23/2002	10/22/02 pt developed severe pain in right arm radiating from shoulder to fingertips. Later same day as vaccination, vaccine was Pneumovax. Pt contacted MD and was told to go to ER. ER MD ordered x-rays and administered ? 10/23 pt had f/u appointment with orthopedist. Ortho's impression was local rx. to vaccine and prescribed Celebrex. Improving 24 hours later.				Y					Y	10/22/2002	10/22/2002	0	Shoulder x-ray	OTH	OTH	NONE	NONE	Osteo-arthritis, lymphosarcoma			1						1	Injection site pain; Injection site reaction	FLU3~SANOFI PASTEUR~U0905FA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0111M~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192085	10/29/2002	MI	33.0	33		F	10/24/2002	10/21/02 was at work. Received Td right arm. Received pneumovax and influenza vaccines left arm. 2 hours later felt general unease. By 8 PM was running a fever and left arm swollen, painful and hard to move. 10/22 Fever 103.5, chills, left arm still red, swollen. 10/23 fever 100.5 early morning--lost fever, heavy feeling in chest, slight coughing started 10/24. Feels light-headed, arm still very painful. Seen here; left arm with 3 indurated area left upper arm. Positive erythema of posterior pharynx. Negative strept screen. As per acknowledgement letter: as I wrote on my VAERS form, I did not give any of the vaccines (they were given  at work) and therefore have no lot #'s or manufact.										10/21/2002	10/21/2002	0	Negative strept A screen.	OTH	OTH	None	None	MVP, Allergy to Nickel; Vitromycin			1						1	Chest discomfort; Cough; Injection site induration; Pain; Pyrexia; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0192086	10/29/2002	PA	31.0	31		F	10/23/2002	8cm area of erythema, induration, tenderness and heat in upper left arm after receiving flu vaccine on 10/21/02. Treated with Benadryl 25mg po q 9 prn, ice packs.				Y					U	10/21/2002	10/22/2002	1	NONE	PUB	OTH	EES, Dimatane DC	NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U0910AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192087	10/29/2002	NY	68.0	68		F	10/22/2002	On 10/16 received Fluzone and allergy shots. On 10/18 developed rash over entire body, papular, red. Faded with Lorataine over 2-3 days.									Y	10/18/2002	10/18/2002	0	NONE	PVT	PVT	Norvase, Atenole, HCT2, synthroid, Cozaar, Premarin, Vioxx	NONE	GERD, hyper			1						1	Erythema; Rash; Rash papular	FLU3~SANOFI PASTEUR~U0930FA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192088	10/29/2002	SC	66.0	66		F	10/16/2002	Shot at app 2pm. Red cheeks at 3 (1 hr pr) hot face (a little). 8pm very blotchy face (6hr pr) 1am very red swollen face (11hr pr). 10/11/02 dermatologist prescribed 20mg preomsone.				Y					Y	10/09/2002	10/09/2002	0	10/4/02 Dermatologist prescribed prednisone 20 mg.	PUB	PVT	Lipitor 20mg	10 day old very slight ???	NONE			1						1	Erythema; Face oedema; Rash macular	FLU3~SANOFI PASTEUR~U0928AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192089	10/29/2002	OR	5.0	5		M	10/24/2002	Shot given 10/16/02-on 10/18/02 pt returns to office with swollen arm L with moderate redness and tenderness over deltoid area of L arm (upper 2/3 of upper arm).				Y					Y	10/16/2002				PVT	PVT		NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~402020~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0192090	10/29/2002	FL	72.0	71		F	10/28/2002	Severe intolerable pain from clavicule to ear and from back to skull to the spinal bone. Fever of 103. Still have a fever of 100, sweats, flu-like symptoms, total debilitation.									U	10/17/2002	10/21/2002	4		UNK	UNK						1						1	Back pain; Bone pain; Ear pain; Hyperhidrosis; Influenza like illness; Pyrexia; Anorexia; Asthenia; Musculoskeletal stiffness; Nausea; Neck pain; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~E34672HA~3~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0192091	10/29/2002	GA	21.0	71		F	10/28/2002	10/25/02 two days post vaccine developed hives, swelling of face, lip and throat. No difficulty with breathing. Swallowing hurts also had flu-like illness. Treated in ER 10/26/02 Solumedrol, Benadryl and Pepcid IV, Toradol IM for pain. Rx: Lortab prn, discharged post treatment.				Y					Y	10/23/2002	10/25/2002	2	metabolic panal  decrease bun of 6; hemogram wnl; diff H neut, lymph; ptt: wnl; protive; wnl	PVT	PVT	Pepcid daily	NONE	NONE			1						1	Dysphagia; Face oedema; Influenza like illness; Laryngeal oedema; Urticaria	FLU3~SANOFI PASTEUR~U0924BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192092	10/29/2002	AL	73.0	73		M	10/28/2002	Diarrhea for 8 days 2 days after the vaccines.				Y					Y	10/15/2002	10/17/2002	2	Stool culture obtained	PVT	OTH	Cardra, Maxzide	NONE	HTN			1						1	Diarrhoea	FLU3~SANOFI PASTEUR~U0882AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1352L~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192093	10/29/2002	OH	74.0	74		F	10/30/2002	The day after receiving her flu shot. The patient noted the injection site was red, warm, tender, swollen. Site was examined and had a 5mmX10mm area of erythema, induration, and warmth.									Y	10/18/2002	10/19/2002	1		PVT	PVT	Tricor 200mg QD	None	Hypertryglycerdemia, Post-menopausal			1						1	Feeling hot; Injection site erythema; Injection site induration; Injection site swelling; Tenderness	FLU3~EVANS VACCINES~E35472AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0192094	10/29/2002	KY	54.0	54		M	10/25/2002	Awoke during the night 10/18/02 with pain and weakness both arms right arm worse than right. Developed fever and cough over the weekend. Has developed rash around the waist the past 1-2 days. No improvement as of 10/25/02.				Y					N	10/17/2002	10/18/2002	1	CT scan, MIR and blod work	PUB	PUB			R shoulder pain/cortizone IM in past MD, lower back problems		KY2002040	1						1	Cough; Muscular weakness; Pain; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U0886AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192095	10/29/2002	CA	32.0	32		M	10/25/2002	10/21/02 started oral typhoid-c/o high fever, chills, diarrhea and slight rash on face. 10/23/02 another dose of oral thphoid with c/o immediate severe diarrhea, high temp, chills and rash on face spreading. 10/24/02 advised pt to descontinue oral typhoid.  F/U both MD if needed.									Y	10/21/2002	10/22/2002	1		PUB	PVT						1						1	Chills; Diarrhoea; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U0885AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~SMITHKLINE BEECHAM~711B6~UNK~IM~RA~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0344M~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TD~CONNAUGHT LABORATORIES~U0530AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1|YF~CONNAUGHT LABORATORIES~UB234AA~UNK~SC~LA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0192114	10/29/2002	GA		62		F	10/15/2002	Received pneumonia shot Wednesday 10/9. One hour after shot, arm started hurting. By bedtime left arm started swelling from shoulder to elbow, red. Client went to ER.				Y					Y	10/09/2002	10/09/2002	0		PUB	PUB		NONE				1						1	Erythema; Pain; Swelling	FLU3~SANOFI PASTEUR~U0925AA~6~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0923L~2~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192128	10/29/2002	PA	69.0	70		F	10/25/2002	Rash developed along right arm after pneumovax shot.				Y					Y	10/22/2002	10/22/2002	0	None	PVT	PVT	Plavix, Paxil, Claritin	None	PCN			1						1	Rash	FLU3~EVANS VACCINES~E34672HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0676M~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192234	10/29/2002	MT	0.0	24		F	10/29/2002	Pt.called to report numbness and tingling in her mouth and over-all itching.Advised to see HCP,and went right away. Was RX'd Zyrtec. On 10/29/02 reports no symptoms.				Y					Y	10/22/2002	10/23/2002	1		PUB	PVT						1						1	Hypoaesthesia; Paraesthesia; Pruritus	FLU3~PFIZER\WYETH~40023~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1353L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192235	10/29/2002	MT	24.0	24		F	10/29/2002	15 minutes post vaccination,client reported having a thick tongue,trouble swollowing.With in 5 minutes she reported feeling hot and chest flushed bright red.Epinephrine,.3ml was administered,911 was called.O2 was given when paramedics arrived(10 more minutes)with SATS @ 100,BP 120/90,chest was clear.Pt.was shakey.She went home that night,and went to MD the next day.She advided she stay home from work,and did not perscribe anything.Today, 10/29,client reports still feeling weak and having a sore throat. Advised client to see provider again today.				Y					Y	10/24/2002	10/24/2002	0		PUB	PVT						1						1	Asthenia; Dysphagia; Pharyngolaryngeal pain; Tongue disorder	FLU3~PFIZER\WYETH~4020023~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0192237	10/29/2002	TX	44.0	44		F	10/29/2002	Day 1:  Red, swollen, sore area (circle over 3 in diameter)around the injection point.  Day 2:  fatigue body achiness, headache, but no fever.  Day 4:  swelling and redness began to subside somewhat, leaving a large doughnut-shaped green bruise with a reddish interior...and a lot of itching. Day 5 (today):  still bruised and itchy.									Y	10/25/2002	10/25/2002	0	n/a	PVT	PVT	Zoloft (150 mg/day)	None	Systemic Lupus Erythematosis			1						1	Contusion; Fatigue; Headache; Injection site erythema; Injection site oedema; Pain; Pruritus	FLU3~EVANS VACCINES~E35472HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0192239	10/29/2002	MD	65.0	65		F	10/29/2002	The patient had a severe swelling and redness around entire arm, reaching to scapula, accompanied by fever from this pneumovax.									Y	10/08/2002	10/08/2002	0	None	PVT	PVT						1						1	Erythema; Oedema; Pyrexia	FLU3~EVANS VACCINES~E31172^A~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~UNKNOWN MANUFACTURER~~1~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0192160	10/30/2002	CA	24.0	24		F	10/24/2002	Bumps on L breast.									U	10/22/2002	10/24/2002	2	NONE	MIL	MIL	Xenadun, oral contraceptive	NONE	NONE			1						1	Abscess	ANTH~MICHIGAN DEPT PUB HLTH~FAV063~1~SC~~ANTHRAX (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U0880AA~5~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192164	10/30/2002	IA	30.0	30		F	10/25/2002	10/22/02 Localized reaction - redness, swelling at injection site. Improved on 10/24/02.									N	10/22/2002	10/23/2002	1	None	PUB	PUB	Paxil, Orthonovum daily	None	NKDA, Mental Retardation			1						1	Injection site erythema; Injection site swelling	FLU3~EVANS VACCINES~E31882GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0192165	10/30/2002	OH	51.0	51		F	10/24/2002	Approximately 24 hours after pneumonia injection in left deltoid, the arm became very red, hot and swollen. Patient described swelling as cottage cheese-like lumps in upper arm muscle. Took aspirin, arms less red and swollen today. Area is not hot to touch.									Y	10/22/2002	10/23/2002	1		OTH	PVT		None	Hx of Bronchitis, Pneumonia			1						1	Feeling hot; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U0933AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1351L~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192166	10/30/2002	MN		56		F	10/25/2002	10/21/02 Patient called clinic to inform provider that she was sick after getting Pneumovax. Had a 4x4 size local reaction in the left arm and temperature at 100 degrees F. Also lost several days at work.										10/15/2002				PVT	PVT	Allegra, Prometrium, Estrate	None	Endometriosis, HTN, Neuroma, Cyst resection in right forearm.			1						1	Pyrexia	FLU3~SANOFI PASTEUR~U0903AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1352L~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192167	10/30/2002	MN	65.0	65		F	10/23/2002	10/12/02 Swelling began in left arm where Pneumovax was given. Local swelling in left upper arm from shoulder to elbow. No redness or fever. 10/13/02 Spread to proximal upper forearm on left. Seen in urgent care. Given Meclizine. Also started on prednisone. 10/15/02 Seen at provider's office. Swelling down per patient, at its worst swelling was about 6 diameter in upper arm. Usual is 2.5. Redness developed in left cheek. Continue prednisone until 17th.				Y					U	10/11/2002	10/12/2002	1	None	PVT	PVT	NTG, ASA, Lipitor, Synthroid, Amerge, Verapannil, Zantac		Vasospatic, Migraine, Hypothyroid, Fibromyalgia, GERD			1						1	Erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U0903AA~4~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1352L~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192168	10/30/2002	NC	5.6	5		M	10/24/2002	Child received first ever flu vaccine and aobut 24 hours later developed tactile fever, warm with vomiting 4 episodes over 10 hour period. Some of these episodes provoked by meals.									Y	10/19/2002	10/20/2002	1	None	PVT	PVT	None	None	Allergic Rhinitis			1						1	Feeling hot; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U0880AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192169	10/30/2002	GA		10		F		Right deltoid site red, swollen (baseball size) since yesterday. 10/22/02 Headache, body aches, nausea since 10/22/02.				Y					Y	10/21/2002	10/22/2002	1		PVT	UNK		Hx of asthma				1						1	Erythema; Headache; Nausea; Pain; Swelling	FLU3~PFIZER\WYETH~4020023~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0923L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192170	10/30/2002	KY	3.5	3		M		Approximately 15 minutes after receiving flu vaccine, child return complaining of elevated wheezing, palms itching and stomach ache. He developed some perioral cyanosis. He was given oral Benadryl, epinephrine, xopenex mininebulizer and oxygen. He was taken by EMS to hospital where he received systemic steroids and ongoing nebulizer treatment.				Y					Y	10/22/2002	10/23/2002	1	Oxygen saturation 88%	PVT	PUB	Albuterol, Amoxil, Gentamicin					1						1	Abdominal pain upper; Cyanosis; Pruritus; Wheezing	FLU3~SANOFI PASTEUR~U0874AA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192171	10/30/2002	FL	75.0	75		F	10/24/2002	Fine red, itching rash began on 10/17/02 11:30pm on arms and feet. Gradually progressed over most of body. No urticaria. Went to ER on 10/19/02 3am. Given Rx: Atarax and Prednisone. Red rash progressed to bruising in groin area.				Y					Y	10/17/2002	10/17/2002	0		PUB	PVT	Premarin, Allegra, Prilosec, Corcide, Detrol LA, KCE	NONE	Hypertension			1						1	Contusion; Erythema; Rash	FLU3~PFIZER\WYETH~4020007~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0192172	10/30/2002	OH	38.0	38		F	10/23/2002	Pt immunized with Fluvirin about 1015A; pt came back about 12N with c/o feeling faint and itching. Pt's eyes were glass-like and she was pale. HR 80bpm and regular. No SOB. No resp. difficulty noted but pt stated her throat felt funny. Pt medicated with Benadryl 50mg IM at 1210P, EMS called and pt transported to  ER at 1220pm.				Y					Y	10/23/2002	10/23/2002	0		OTH	PVT	NONE	NONE	NONE			1						1	Dizziness; Pallor; Pruritus; Staring	FLU3~EVANS VACCINES~E34102HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0192173	10/30/2002	MN	64.0	64		M	10/24/2002	10/18/02 provider saw pt at church event and noticed pt swelling, redness and pain in right arm. Pt started on Keflex. 10/21/02 provider saw pt in clinic. Pt reports fever and swelling was worse on Sunday. Redness improving swelling improving. Pt to continue on Keflex, ice and heat area.				Y					Y	10/16/2002	10/18/2002	2	NONE	PVT	PVT	Glyburide, Primivil, Nowasc, ASA, Melformin, Avandia, Zocor, Motrin	NONE	Hyperlipidemia, diabetes, HTN, sleep apnea, heart murmur, proteinuria, right side flaute, back pain, neck problem with disc			1						1	Injection site erythema; Injection site oedema; Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~U0903AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0111M~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192174	10/30/2002	CA	9.0	9		M	10/24/2002	Approximately 12-14 hrs after vaccine administration, pt developed urticarial rash all over body and mom denied any other new exposures (food, deterg) etc. in pt's environment. Pt treated with Benadryl 2-3d course and Prednisone.				Y					Y	10/22/2002	10/23/2002	1	NONE	PVT	PVT	Digoxin, Xanitidire, Enalapril, Polyvisol, folic acid, FE sulfate, sulfasalazine, ladesonide, allaternl prn	NONE	Asthma, Down's Syndrome, h/o heart prob now with pacemaker, b/l undescende , h/o seire, h/o GI bleeds, has G-tube			1						1	Urticaria	FLU3~SANOFI PASTEUR~U0885AA~5~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192175	10/30/2002	MS	23.0	23		F	10/22/2002	30 mins after shot I had welps all over my body.				Y					Y	10/18/2002	10/18/2002	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U0888AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192176	10/30/2002	FL	76.0	76		M	10/23/2002	Fever, chills, bodyache, 1wk co-incident with Altace starting increase WBC 24k. Serum sickness.				Y					Y	10/08/2002	10/08/2002	0	WBC 24K sed rate 33	PVT	PUB	Altace	NONE	NKA			1						1	Chills; Pain; Pyrexia; Serum sickness; White blood cell count increased	FLU3~SANOFI PASTEUR~U0879AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192177	10/30/2002	ID	56.0	55		F	10/24/2002	Received Flu injection at 8am on 10/8/02. On 10/11/02 at 8:30am I became very hot and my skin felt like I was on fire/upon looking in the mirror. I was as red as a beet. I felt like hot led pouring all over me-this lasted 45mins. It happened again on 10/12/02 and again on 10/13/02 and last on 10/14/02.									Y	10/08/2002	10/11/2002	3	NONE	PUB	OTH				~Influenza (Seasonal) (no brand name)~1~47.00~In Patient		1						1	Erythema; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192178	10/30/2002	ME	65.0	64		F	10/25/2002	Hives/itching all over body. Chest and jaw tightness. Decrease blood pressure. Tx Benadryl, Epinephrine and steroidal injection then oral steroids.				Y					Y	10/23/2002	10/23/2002	0	NONE	OTH	OTH		NONE	Environmental allergies			1						1	Chest discomfort; Pruritus; Urticaria; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0904CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0904CA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0192179	10/30/2002	MT	51.0	51		F	10/24/2002					Y					U	10/23/2002	10/23/2002	0		PUB	UNK		NONE				1						1	Unevaluable event	FLU3~PFIZER\WYETH~1159L~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~4020025~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192180	10/30/2002	OK	31.0	31		F	10/24/2002	Influenza vaccine administered 2pm.4:45pm began to itch all over. 9pm took Benadryl 50mg. Worse in morning. Took Dph 50g at 9am.				Y					U	10/23/2002	10/23/2002	0	NONE	UNK	UNK		NONE	NONE			1						1	Pruritus	FLU3~SANOFI PASTEUR~U0888AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192181	10/30/2002	VA	66.0	66		F	10/23/2002	Flu shot admin. Pt denied any allergies. 1hr 45 mins pt came back to health dept. arm swollen, warm to touch and painful. Inst. to use ice compresses x 24hr then heat. Call MD or call 911 if resp. symptoms. 10/23 pt states has rash. 10/23 MD notified. Pt inst. to call MD and make an appt.									U	10/21/2002	10/21/2002	0		PUB	OTH		NONE	NONE			1						1	Injection site oedema; Injection site pain; Injection site warmth; Rash	FLU3~SANOFI PASTEUR~U0922AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0923L~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U0524AA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0192182	10/30/2002	VA	56.0	56		F	10/23/2002	Pt with 2 x 4 1/2 bruise around injection site down arm. Yellow in color with dark purple at bottom states feeling better. Encouraged to call LMD. No ASA that am.									U	10/16/2002	10/19/2002	3		PUB	OTH	ASA QDD	NONE				1						1	Contusion	FLU3~SANOFI PASTEUR~U0881AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192183	10/30/2002	CA	63.0	63		F	10/17/2002	Patient had vaccine administered at 6PM. Noticed a red circle and slight swelling at 10AM the following morning. Red circle was quarter-sized when first noticed and has since grown to 4.5 inches wide and is warm and mildly itchy and sore 2 days later (48 hours).									U	10/15/2002	10/16/2002	1		OTH	UNK	Levoxyl		Penicillin allergy			1						1	Feeling hot; Injection site erythema; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U0875AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192184	10/30/2002	DE	68.0	68		F	10/24/2002	Itching and small hives 16 hours after shot. Took 2 Benadryl tablets and put cortisone ointment on hives.									Y	10/15/2002	10/16/2002	1		OTH	OTH	Zocor, Prilosec, Librax, Allegra		Seasonal allergies			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0922AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192185	10/30/2002	MN	3.25	3		M	10/22/2002	Wheezing started approx 4pm by 5pm wheezing worsened, rapid respirations. Mom gave Pulmicort, Xopenex neb. Sx Continued, was given Prednisolone 4ml oral. Treatment continued with Pulmicort and Xopenex through Sun 10/20/02.									Y	10/19/2002	10/19/2002	0	NONE	PVT	PVT	Xopenex, Zyrtec	NONE	Asthma, allergies			1						1	Dyspnoea; Wheezing	FLU3~SANOFI PASTEUR~U0888AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192186	10/30/2002	WI	72.0	72		M	10/21/2002	Patient experienced left arm swelling from mid-arm to wrist approximately 24 hours after receiving both vaccines. Swelling persisted for about 3 days and then gradually resolved. Patient could not touch his nose because the swelling in elbow/forearm was so bad.				Y					Y	10/17/2002	10/18/2002	1		PVT	UNK	Glipizide, HCTZ, Lotrel, Glucophage	None	Diabetic, Hypertension, Hyperlipidemia			1						1	Joint range of motion decreased; Swelling	FLU3~SANOFI PASTEUR~U0888AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0172M~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192187	10/30/2002	DE	55.0	55		F	10/24/2002	12 hours following 2002 flu shot, extreme body pain, chills, 102 fever. 36 hours 100 degree fever. Next 2 days, headache, body aches.									Y	10/18/2002	10/19/2002	1	None	OTH	OTH		None	None			1						1	Chills; Headache; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192188	10/30/2002	MD	30.0	30		F	10/27/2002	Influenza virus received on 10/18/02. Immediately after the injection, the site was itchy. After about 10 minutes, itching subsided. The following day, the injection site developed a hardened spot around it. The spot (area) is still hard today, measuring approximately 1x1.									N	10/18/2002	10/18/2002	0	None	PUB	UNK	Orthocycline	None	Silk, Dust Mite, Pollen Allergies			1						1	Injection site induration; Pruritus	FLU3~SANOFI PASTEUR~U0904CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192189	10/30/2002	TN	37.0	37		F	10/23/2002	Patient received flu vaccine on 10/21/02. Starting itching on 10/22/02. Still itching 10/23/02 and a knot appeared at injection site. Told patient to take Benadryl. Call back if blood pressure changes, nausea, or rash.									Y	10/21/2002	10/22/2002	1		OTH	PVT		None	None			1						1	Injection site nodule; Pruritus	FLU3~EVANS VACCINES~E31872GA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0192190	10/30/2002	IN	7.0	7		F	10/22/2002	Hive-like rash on left arm and neck with itching on both arms, neck and face. No SOB, no LOC, no lethargy. Treated with Benadryl.									Y	10/22/2002	10/22/2002	0		PVT	PVT						1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~U0921CA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192191	10/30/2002	NC	30.0	30		F	10/28/2002	Fever/chills starting 10/23/02. Night sweats 10/23 through 10/25. Red rash all over body for 2 days starting yesterday. No sore throat, some abdominal cramping. Hasn't seen doctor yet.									U	10/21/2002	10/23/2002	2		PUB	OTH	Prenatal vitamins. BC Pills					1						1	Abdominal pain; Chills; Night sweats; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192192	10/30/2002	CA	60.0	0	.7	F	10/28/2002	Acute nausea, vomiting and diarrhea starting 15 minutes after injection. Elevated WBC 24,00.				Y					Y	10/23/2002	10/23/2002	0		PVT	PVT		None	Codeine Allergy, Elevated cholesterol, hypertension			1						1	Diarrhoea; Nausea; Vomiting	FLU3~EVANS VACCINES~E31212GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0192193	10/30/2002	FL	1.0	0	1	F	10/28/2002	Next day a lump was on left and right leg.									Y	10/17/2002	10/18/2002	1		PVT	PVT	None	None				1						1	Injection site mass	DTAP~SANOFI PASTEUR~U0581CA~3~~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U0877AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0641M~3~~LL~HIB + HEP B (COMVAX)~1	USA		Influenza
0192194	10/30/2002	MI	50.0	50		F	10/28/2002	Localized reaction--bright red, swollen, hot to touch, sore--approximately 4x2.5. Increase in size for 36 hours after injection.										10/26/2002	10/26/2002	0		OTH	OTH	Tenormin	None	None	localized reaction~Influenza (Seasonal) (no brand name)~1~45.00~In Patient		1						1	Feeling hot; Injection site erythema; Injection site swelling	FLU3~EVANS VACCINES~E31902HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0192195	10/30/2002	MD	54.0	54		F		Redness of left upper arm; edema of arm.									U	10/24/2002	10/25/2002	1		PVT	OTH		Abdominal pain	Diabetes, HTN			1						1	Erythema; Oedema peripheral	FLU3~PFIZER\WYETH~4020024~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0541M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192196	10/30/2002	LA	68.0	68		F	10/28/2002	Oedema; swelling of entire arm										10/14/2002	10/14/2002	0		PVT	PVT	Lotrel, Lipitor, Aterolol, Vioxx, TUMS	HTN				1						1	Oedema; Oedema peripheral	FLU3~EVANS VACCINES~E320726A~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1161L~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192218	10/30/2002	OH	66.0	66		F	10/22/2002	Red area RUE at injection site, site warm to touch (+) edema. Tx: Beandryl 25mg bid x 3d, Augmentin 875 bid x 5d.				Y					Y	10/21/2002	10/22/2002	1	NONE	PVT	PUB	Rythmol, Synthroid, Actonel, Advair, Ventolin HFA, Singulair, Clarinex, Prednisone, Nasonex		COPD, osteoporosis, PND			1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U0945AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1353L~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192242	10/30/2002	GA	44.0	45		F	10/30/2002	experienced tachycardia, difficulty sleeping and difficulty breathing.  It started within several hours of receiving the vaccination and persisted for more than 24 hours									Y	10/29/2002	10/29/2002	0		UNK	PVT	None	None	general hay fever			1						1	Dyspnoea; Insomnia; Tachycardia	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192286	10/30/2002	NH	51.0			U	10/30/2002	11 hours preceeding injection,high fever, chills, dry mouth,ache, large muscle cramps in legs weak feeling. low grade fever after.									Y				na	PUB	UNK		none				1						1	Asthenia; Chills; Dry mouth; Muscle spasms; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192287	10/30/2002	AZ	26.0	26		M	10/30/2002	1.5 hours after receiving vaccine pt began having pain from shoulder to waist on the side of body where he received the vaccination, felt nauseated and was having hot flashes, was mildly diaphoretic with flushed skin and began erperiencing rhinorrhea.  B/P ranged 130-80 to 114-80 with HR 72-82, RR 20.  Denied dizziness or dyspnea.  Pt was observed for approximately 30 minutes, and began feeling better.  Advised to take tylenol, not ASA, for back pain, and Benadryl 25 mg and was sent home for the rest of the day from work.									Y	10/28/2002	10/28/2002	0		PVT	PVT						1						1	Flushing; Hot flush; Hyperhidrosis; Nausea; Pain; Rhinorrhoea	FLU3~EVANS VACCINES~334102HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0192288	10/30/2002	MA	52.0	52		F	10/30/2002	Patient complained of tightness in throat and face after receiving vaccine.  benadryl given. VSS. No other symptoms.  Symptoms resolved automatically.									Y	10/23/2002	10/23/2002	0		PUB	PVT		none	unknown			1						1	Throat tightness	FLU3~SANOFI PASTEUR~vo969AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192290	10/30/2002	NE	41.0	35		F	10/30/2002	Received flu vaccine on Oct. 25,2002 at 0910am in the Rt. Gluteus Max.  Awakened at 1100am (works nights) with severe muscle and body aches, esp. in the lower part of body.  Was unable to move legs briskly and felt like a load of bricks were sitting on legs.  Felt restless and could not get comfortable because of body pain and soreness.  Has chills and was dozinf off and on.  Had some confusion, found self running down the halway at home very dizzy, lightheaded.  Had sensation of blacking out, did not fall.  HR 120 - 130  BP 112/88 T- 99.4 - 101.8 Has audible wheez  wiht exertion.  Severe weekness, fatique. No discomfort at injection site.  Hve feeling of heart pounding.  Nausea wiht dry heaves, loss of appitite.					Y	1			Y	10/25/2002	10/25/2002	0	Cardiac Workup was negative for cardiac involvement (King of Hearts test is pending) UA SPg 1.020 Many Bacteria rare yeast Not a clean catch was treated for UTI Chem Panel was normal	PVT	PVT	Celebrex 200mg BID Tylenol PRN	None (Possible UTI)	Hx of Palpitations/PVCs over the past year or so			1						1	Anorexia; Asthenia; Chills; Dizziness; Fatigue; Nausea; Pain; Restlessness; Retching; Syncope; Wheezing	FLU3~SANOFI PASTEUR~U0882AA~1~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0192292	10/30/2002	NE	51.0	51		F	10/30/2002	Vaccine received on October 25, 2002 in the AM at 1600 was chilling, had severe aches, very tired, felt Ice Cold (did not take a temp)  Felt better by the evening of the 27th.									Y	10/25/2002	10/25/2002	0	None	PVT	PVT	Ziac 2.5 Mg QD	None	Hypertension			1						1	Chills; Fatigue; Pain	FLU3~SANOFI PASTEUR~U0882AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192293	10/30/2002	CA	43.0	43		F	10/30/2002	Generalized flushed feeling, tachycardia, dizzyness									Y	10/29/2002	10/29/2002	0	none	PVT	PVT	Synthroid Progestin	none	PCN Tetanus Toxoid			1						1	Dizziness; Flushing; Tachycardia	FLU3~SANOFI PASTEUR~00905FA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192295	10/30/2002	CA	38.0	38		F	10/30/2002	Pain, itching, swelling, hot area approximately 10cm surrounding injection site									Y	10/29/2002	10/29/2002	0	none	PVT	PVT	Celexa	none	Reglan Serazone Sulfa			1						1	Feeling hot; Oedema; Pain; Pruritus	FLU3~SANOFI PASTEUR~00905FA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192296	10/30/2002	NJ	16.0	16		F	10/30/2002	Hives on the next day on the arms and legs.										10/29/2002	10/30/2002	1		PVT	UNK		cold				1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0191620	10/31/2002	KY	45.0	45		F	10/28/2002	From faxed correspondence received at manufacturer on 10/22/02, it was reported by a health care professional that a 45 year old female, who on 10/15/02 at 15:00 was vaccinated Fluzone (lot # U0910AA) IM in the left deltoid. Five minutes after vaccination, the patient experienced nausea, flushed face, difficulty swallowing, and shortness of breath. She was seen in the ER and treated with Solu-medrol IV, Pepcid IV, and oxygen. She was discharged to home with Prednisone dose pack and Tagamet. On 10/16/02, the patient presented in the ER again and was hospitalized on 10/17/02 for two days. Patient recovered. From additional information received on 10/2/03 from the employee health deparmtent at a hospital, it was reported that the patient was hospitalized for two days. (admitted on 10/17/02 and discharged on 10/19/02) for having a fairly severe allergic reaction to the FLUZONE vaccine. The patient experienced a persistent flushing, but it was unclear if it was a persistent allergic reaction as opposed to a pyrogenic response to the vaccine. No definite allergic reactions were noted, although she did have an episode of flushing and felt poorly. Treatment included steroids and H2 and H1 blockade. The patient was discharged on 40mg of Prednisone for four days, then tapered off of it, Zyrtec once daily and 400mg of Tagamet twice a day. on the day of discharge, there was no evidence of any severe end-organ damage, such as shock, bronchospasm or stridor. The patient was eating, walking and desired to be discharged. The patietn was discharged in improved contidion, but did not have a headache, for which Advil and/or Ultracet were not very effective. It was not reported whether the patient recovered from these events.				Y	Y	2			Y	10/15/2002	10/15/2002	0	Per the discharge diagnosis, leukocytosis and thrombocytosis, likely secondary to steroids and acute phase reaction from stress. The patient was to follow up with a physician one to two weeks after discharge and it was being considered to repeat the lab findings including BMP and CBC.	PVT	PVT	Effexor, Tagamet, Lasix, Zyrtec, Lotril		Allergic to Batrim and Tetanus. From follow up on 10/2/03: The patient has a history of hypertension, depression, midly low potassium and status post cholecystectomy and Nissen fundoplication.		U200200863	1						2	Dysphagia; Dyspnoea; Flushing; Nausea; Dysphagia; Dyspnoea; Flushing; Leukocytosis; Nausea; Thrombocythaemia	FLU3~SANOFI PASTEUR~U0910AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0910AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0192247	10/31/2002	CA	81.0	81		F	10/28/2002	Information has been received from an 81 year old female pt, born on 12/27/1920, who was vaccinated with Fluzone SV '2002-'2003 USP on 10/17/02. The day after vaccination, she felt weak-had no strength. She was admitted to hospital on 10/20/02 and was discharged the next day. The outcome of the event was not reported.					Y	1			U	10/17/2002	10/18/2002	1		OTH	OTH					U200200861	1						1	Asthenia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0192252	10/31/2002	MO	72.0	72		F	10/29/2002	On 10/10/02 pt noticed red spots on calf, by 10/12/02 pt had wide spread rash, physician on-call notified by pt andwas placed on medrol pk. Hosp admit on 10/15/02 for urticaria.					Y	2			Y	10/08/2002	10/10/2002	2		PVT	UNK						1						1	Erythema; Rash; Urticaria	FLU3~EVANS VACCINES~E35722NA~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0192254	10/31/2002	TX	1.25	1	.3	F	10/22/2002	Pruritic rash to face and body.				Y					Y	10/18/2002	10/18/2002	0		PVT	PVT	None	None	None			1						1	Rash pruritic	FLU3~PFIZER\WYETH~4020004~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0192257	10/31/2002	OH				U	10/24/2002	The infection control nurse at hospital received reports of two employees--one male and one female--with localized red, hot reaction at the site of an influenza vaccine injection. The male reported additional pain under the arm. A third employee reported a rash 12 hours after receiving the vaccine plus shortness of breath. Our nurse contacted the manufacturer about her concern that the 5/8 inch needle on the pre-filled syringe was too short in most cases for proper administration of this IM preparation. If the vaccine was being delivered into the SC tissue instead of muscle, would adverse reactions be increased and would clinical efficacy be diminished. Response from manufacturer quoted that decision on needle size must be individualized and that 1 to 1.5 inch need length is recommended for IM injection into the deltoid muscle in all adults. Based on this information, we are puzzled why manufacturer chose to package their products with a 5/8 inch needle.										10/21/2002	10/23/2002	2		PUB	UNK						1						1	Dyspnoea; Feeling hot; Injection site erythema; Pain; Rash	FLU3~EVANS VACCINES~E33092HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0192259	10/31/2002	GA	43.0	43		F	10/30/2002	Soreness and weakness in left arm since shot.									Y	10/16/2002	10/16/2002	0		PVT	PVT						1						1	Injection site pain; Muscular weakness	FLU3~SANOFI PASTEUR~40924DA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192260	10/31/2002	IL	69.0	69		M	10/29/2002	Chills-sore throat-cough-wheezing and some fast heart beat-was all gone in 3 days, doing fine now.									Y	10/24/2002	10/25/2002	1		MIL	MIL		NONE	NONE			1						1	Chills; Heart rate increased; Pharyngolaryngeal pain; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192261	10/31/2002	IN	51.0	51		M	10/29/2002	Received flu shot 10/17/02. Early Fri morning felt achy all over, but resolved. On 10/22/02 felt 'bad in general. Wed 10/23 became achy again; flushed that evening. Thurs aft. 10/24/02 noticed L side of face drooping, mouth feeling funny. Unable to blink L eye or drink well mouth not closing completely. Saw MD dx. with Bell's palsy. Given eye oint. on 10/31/02. Also c/o pain L ear.				Y					N	10/17/2002	10/24/2002	7	NONE	PUB	PUB	NONE	NONE	Allergy: sulfa, Demeral; otherwise no meds, healthy.			1						1	Ear pain; Eye disorder; Facial palsy; Feeling abnormal; Hot flush; Pain	FLU3~PFIZER\WYETH~4020025~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0192262	10/31/2002	FL	21.0	21		M	10/29/2002	Headache, sweating, nausea, vomiting, diarrhea.									U	10/28/2002	10/28/2002	0	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Diarrhoea; Headache; Hyperhidrosis; Nausea; Vomiting	FLU3~EVANS VACCINES~33392GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0192263	10/31/2002	TN	26.0	26		F	01/29/2002	45 min after to receiving IM flu vaccine noticed itching at injection site, arm and trunk. Blurred vision and cognitive impairment. Went to hospital ER.				Y					Y	01/26/2002	10/26/2002	273	NONE	PUB	PVT	Delexa, Depo	NONE	Naproxn allergy			1						1	Cognitive disorder; Injection site hypersensitivity; Pruritus; Vision blurred	FLU3~SANOFI PASTEUR~U0955A~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192264	10/31/2002	MO	74.0	74		F	10/29/2002	Pt had lethargy, body aches, chilled and slight increase of temp. no appetite.									Y	09/27/2002	10/03/2002	6	NONE	PVT	UNK		NONE	Anemic iron def., restless leg syndrome, hypertension			1						1	Anorexia; Body temperature increased; Lethargy; Pain	FLU3~EVANS VACCINES~33142GA~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0192267	10/31/2002	NJ	82.0	82		M	10/15/2002	10/09/2002 evening- temp 100-102.7, muscles aches , headache, 10/10/2002- temp increase 102.7. pt has had increase of temp for 7 days since 10/08/2002. Last pt seen by MD on day 6 given antibiotics and Allegra. Last night temp 103.7. Pt took 2 ASA BID- History triple bypass. 05/01 concerned with notting. MD examined pt. No apparent infection on OE				Y					N	10/08/2002	10/09/2002	1		PUB	UNK		NONE	Triple bypass 05/2001		200226	1						1	Body temperature increased; Headache; Myalgia	FLUX~UNKNOWN MANUFACTURER~U0881AA~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0192268	10/31/2002	NJ	55.0	55		M	10/23/2002	Wife reported within 1 hour of receiving vaccine, severe h/a. During that night, achy , chills, sweats, temp 101 degrees. Remained in bed for 19 hrs. Notified MD- Tylenol and liquids- treatment . 2nd day after vaccine. sweating, nausea, dizzy. Last flu vaccine apprx. 10 yrs									Y	10/17/2002	10/17/2002	0		PUB	PUB	NONE	NONE	NONE		200227	1						1	Chills; Dizziness; Headache; Hyperhidrosis; Nausea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U0881AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192270	10/31/2002	SC	55.0	55		M	10/28/2002	10/25/2002 Pt received flu shot and pheumonia shot . Arm received pheumonia shot in QT red and warm to touch. Started on 10/26/2002									Y	10/25/2002	10/26/2002	1	NONE	PVT	PVT	Nexiom	NONE	PUD			1						1	Erythema; Feeling hot	FLU3~SANOFI PASTEUR~U0880AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1050L~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192271	10/31/2002	GA	31.0	31		F	10/30/2002	Nausea, vomiting, dry heaves, tachycardia until 5am 10/17/02. Pt noted similar reaction from previous hep B vaccination. (Possible reaction preservative component?)									Y	10/16/2002	10/16/2002	0		PVT	PVT						1						1	Nausea; Tachycardia; Vomiting	FLU3~SANOFI PASTEUR~40924DA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192272	10/31/2002	CA	80.0	80		F	10/29/2002	Dizziness. Couldn't move and get up. Muscle aches. Patient recovered within 3 days. Has not seen or called physician. Change to non-serious.									Y	10/25/2002	10/26/2002	1		UNK	UNK	Adalet; Glucophage; Starlic eye drops; Cozoar		Glaucoma; Hypertension; NIDM; Chronic allergic rhinitis; Bronchitis.			1						1	Dizziness; Hypokinesia; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192277	10/31/2002	OH	47.0	47		F	12/12/2002	Sudden onset vertigo, nausea, vomiting followed by facial swelling and red blotches went to ER given o2 and Phenergan.				Y					Y	10/23/2002	10/23/2002	0		OTH	PVT	Synthroid, Prevacid	NONE	Allergy sulfa, hypothyroid-on replacement, GERD			1						1	Erythema; Nausea; Rash macular; Swelling face; Vertigo; Vomiting	FLU3~SANOFI PASTEUR~UO881AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192279	10/31/2002	OH	54.0	54		F	10/21/2002	On 10/18/02 bruising at site of injection then redness/itching started on 10/19/02.									Y	10/17/2002	10/18/2002	1	NONE	PVT	PVT		NONE	Allergy pcn, hypertension			1						1	Contusion; Injection site erythema; Injection site hypersensitivity; Pruritus	FLU3~SANOFI PASTEUR~U0904CA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192280	10/31/2002	MD	51.0	49		F	10/25/2002	Cellulitis R arm given Dynabac 250mg #16.									Y	10/24/2002	10/24/2002	0	NONE	PVT	PVT		NONE	Asthma			1						1	Cellulitis; Injection site reaction	FLU3~EVANS VACCINES~328526A~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0445M~2~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192281	10/31/2002	VA	67.0	67		M	10/28/2002	Hives on trunk, Benadryl 25-50 q 4-6h. Prednisone 40mg T QD x 5 days.				Y					Y	10/21/2002	10/22/2002	1		PVT	PVT	Prilosec 40mg, Nevatin, Lisonpril 5mg, ASA, Dicoxin	Non-hodgkins lymphoma	Allergic to pcn. DX MVP, GERD, hx of Tia asthma (mild)			1						1	Urticaria	FLU3~SANOFI PASTEUR~U0921EA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192283	10/31/2002	OH	20.0	20		F	10/25/2002	Influenza vaccine administered at library. Client denied allergy to eggs. Had never experienced contact with thimerosal. Denied allergy to latex. Reported never having had a flu vaccine. Flu vaccine administered as prescribed by CDC. Instructed to stay for 20 minutes. As client walking to chair, client collapsed. Right side of face and body to midline turned red. Shallow respirations and weak or no pulse. 911 activated. 0.3mg epinephrine x2 administered IM right thigh. Client regained consciousness and was transported to hospital. Called 10/24/02 and spoke with father of client and he reported that client was discharged from ER at 5:00PM and was resting. Called 10/25/02 and spoke with father of client and he reported that client was sore in neck and chin but was doing OK. Suggested that client should see her family MD and not take any more flu vaccine in future.				Y					Y	10/24/2002	10/24/2002	0	None	PUB	PVT	None					1						1	Asthenia; Dyspnoea; Erythema; Pulse absent	FLU3~SANOFI PASTEUR~U0881AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192284	10/31/2002	SC	76.0	76		M	10/25/2002	Injection site right upper arm. Patient reported swelling from elbow to lower arm next day. Area from elbow down was red, warm to touch, swollen, discoloration noted on elbow. State slight soreness at injection site. Questionnable cellulitis.									Y	10/22/2002	10/23/2002	1		PUB	PUB	Prevacid, Bextra, Cycline	None	Iodine; Arthritis rheumatoid; Asbestosis			1						1	Erythema; Feeling hot; Injection site pain; Injection site swelling; Skin discolouration	FLU3~PFIZER\WYETH~4020021~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0996L~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192297	10/31/2002	CA	38.0	38		M	10/31/2002	itching, redness & slight soreness in injection area along left arm, slight nervousness, mild scratchy throat/cough post injection.  Patient took P/O Ephedrine hydrachloride & Diphenhydramine hydrachloride									Y	10/29/2002	10/29/2002	0		UNK	PVT	primatene (after injection)		Allergy to tetanus toxoid	Swelling/redness/soreness at injection site. Shaking/nervousness/coughing~Tetanus Toxoid (no brand name)~1~21.00~In Patient		1						1	Cough; Erythema; Injection site pain; Nervousness; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192355	10/31/2002	MD	59.0	59		M	10/31/2002	Time: 13 hours after administration of flu vaccine.  Patient awoke 1 hour after going to sleep and experienced episode of extreme full-body shivering.  Went on for about 1/2 to 1 hour or so and then subsided.									Y	10/30/2002	10/31/2002	1	N/A	UNK	PUB	Lipitor Prevacid Doxicyline Urocit-K	N/A	N/A			1						1	Chills	FLUX~UNKNOWN MANUFACTURER~Unknown~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192178	11/01/2002	MI		64		F	10/30/2002	Hives all over her body, itching, chest, and jaw tightness occurred less than 45 minutes after shot. 10/23 still on oral steroids because of itching.				Y					Y	10/23/2002	10/23/2002	0		OTH	PUB	Allegra		Environmental allergy		ME02004	1						2	Chest discomfort; Pruritus; Urticaria; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0904CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0904CA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0192299	11/01/2002	OR	25.0	25		F	10/30/2002	It was reported that approximately 23 year old female received Fluzone SV '2002-'2003 (lot U0919AA) in the left deltoid on 10/17/02. Ten to fifteen minutes post-vaccination, the pt developed redness and itchiness on her left deltoid where the injection was administered. She then experienced nausea and vomiting. She was medicated with Benadryl, a shot of methodexozone and was given epinephrine within a half hour of receiving the vaccination. It was reported that the pt recovered and is doing well. Seriousness criteria: other medically significant (OMIC).  A 15-day follow up report received 9/9/2003 adds: From additional info received on 09/02/2003 from a registered nurse, it was reported that the pt is a 25-year-old female who had hay fever at the time of the vaccination. The pt received Fluzone SV '2002-'2003 USP on 10/17/2002 at 10:00 AM, which was her first dose. The pt did not receive any other vaccinations at that time. The onset of adverse events was noted to be at 10:01 AM, 60 seconds after the vaccine was administered. The pt's date of birth was provided. No further info is anticipated, this case is considered closed.				Y					Y	10/17/2002	10/17/2002	0		OTH	OTH					U200200866	1						1	Injection site erythema; Injection site hypersensitivity; Nausea; Pruritus; Vomiting	FLU3~SANOFI PASTEUR~UO919AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192308	11/01/2002	OH	68.0	68		F	10/25/2002	5x5 cm indurated area									Y	10/23/2002	10/23/2002	0	NONE	PVT	PVT	KCL 10mg QD, Premarin 0.625mg, Furosemide 40 mg QD, Synthyroid 0.2mg QD, Avapro 150 mg QD, Glucophage 850mg TID, Tenovate Ovant 0.5%, Elavil 25mg , Amaryl 8mg, Glucephe x R 50,  amcryl, Acterol,Actos	NONE	PCN Allergy/HTN, DMII. hypothyroid			1						1	Injection site induration	FLU3~SANOFI PASTEUR~U0937AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192309	11/01/2002	GA	55.0	55		F	10/24/2002	10/22/02 10pm-tep 99.2 degrees. 10:30 99.4. 11:00-100.2. 11:30-100.1. Chills accompanied temperature elevation beginning at 10pm. Temp spiked again on 10/23 at 6pm-99.2.									Y	10/22/2002	10/22/2002	0		UNK	UNK	Multivitamin, calcium, baby aspirin					1						1	Chills; Pyrexia	FLU3~SANOFI PASTEUR~U092244~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192310	11/01/2002	VT	51.0	52		F	10/25/2002	Severe headache x 36-48 hrs. (migraine- like- acute onset 12 hrs after vaccine- awoke pt from sleep)									Y	10/22/2002	10/23/2002	1	NONE	PVT	UNK		NONE	History of migraines			1						1	Early morning awakening; Headache	FLU3~EVANS VACCINES~E35492KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0192311	11/01/2002	LA	63.0	63		F	10/25/2002	Large red raised area 3inches x 3 inches with streaking to inner arm									U	10/22/2002	10/22/2002	0		PVT	OTH	Lozol, DTU, Toprol,Arthrotec	NONE	Sulfa- HBD, Hypothyroid- Osteo Arthritis			1						1	Cellulitis; Rash erythematous	FLU3~SANOFI PASTEUR~U0903AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192312	11/01/2002	MO	58.0	58		M	10/24/2002	Felt well at time of injection. Next AM woke up with whole body aching esp shoulders. by 4pm very hot, early AM cold and shaking. The next day hot and cold. Temp 103 to MD 10/21. Doxycycline 50 BID prescribed. 10/24/02 better best day since shot.				Y					Y	10/18/2002	10/19/2002	1	Chest x-ray, urinalysis, blood work-wnl	PUB	PVT	NONE	NONE	NONE			1						1	Pain; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U0903AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192313	11/01/2002	MA	73.0	73		F	10/21/2002	Received flu shot on 10/10 sometime between 9am and 11am. Apprx. 6pm on 10/10, complained of very intense headache, nausea with dry heaves, profuse perspiration, and temp. Symptoms lasted 12 hrs.									Y	10/10/2002	10/10/2002	0		PUB	PUB		NONE				1						1	Headache; Hyperhidrosis; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~U0879AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192314	11/01/2002	CA	66.0	66		F	10/22/2002	C/O dizziness, dry mouth, sweating, and vomited X T. C/O blood shot eyes today. Two days late,r pt c/o headache x 4 days but now resolved. Pt states above symptoms resolved but states not feeling my normal good self.				Y					U	10/14/2002	10/14/2002	0	NONE	PVT	PVT	Prempro, Fosamax, levoxyl	NONE	Allergic to codeine			1						1	Dizziness; Dry mouth; Headache; Hyperhidrosis; Malaise; Ocular hyperaemia; Vomiting	FLU3~PFIZER\WYETH~4020028~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0192315	11/01/2002	OK	51.0	51		F	10/25/2002	Redness, swelling in L arm, chills.									Y	10/22/2002	10/22/2002	0		PUB	OTH						1						1	Chills; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U0911BA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0210M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192316	11/01/2002	NY	41.0	40		F	10/25/2002	c/o pain in the left ear, left side of neck, left upper motor area pains. Erythema and induration in his left arm (deltoid) injection site.									N	10/23/2002	10/24/2002	1	NONE	PVT	UNK		NONE	NONE			1						1	Ear pain; Injection site erythema; Injection site induration; Pain	FLU3~PFIZER\WYETH~4020003    exp~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0192317	11/01/2002	MA	62.0	60		M	10/25/2002	Pain, swelling, tenderness R arm.				Y					U	10/18/2002	10/18/2002	0		PVT	PVT			DM, HTN, DJD, DDD			1						1	Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4020013~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0192318	11/01/2002	OR	32.0	32		F	10/24/2002	Pain, swelling at injection site. Exam at one week later; only redness and slight discomfort, no induration.				Y					N	10/16/2002	10/16/2002	0	NONE	PVT	PVT	Levoxyl, HCT2, Glucophage, Ranitidine, Nexium, Dexamethasone, Micro K	NONE	Polycystic ovarian disease, GERD, hypothyroidism, asthma, irritable bowel syndrome, obesity			1						1	Discomfort; Injection site erythema; Injection site oedema; Injection site pain	FLU3~EVANS VACCINES~30412GA~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0192319	11/01/2002	MI	43.0	43		F	10/16/2002	Employee received flu vaccine at 2:10 10/11/2002. Took Albutrol. Adverse effect at 2:25pm. SOB and tightness throat, hoarseness, diaphoresis, headache. Health Service called MD called .02 Benadryl 50 mg IM. to Er IV's prednisone IV, Pepcid, Albutrol, Benadyl RX. Discharged with Prednisone dose pack. See her MD 10/14/2002 received second dose pack. Antibiotics and inhaler continued				Y					Y	10/11/2002	10/11/2002	0	NONE	OTH	PVT		Has asthma	Eclor, Generic theodur			1						1	Dysphonia; Dyspnoea; Headache; Hyperhidrosis; Throat tightness	FLU3~SANOFI PASTEUR~U0905FA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192320	11/01/2002	TN	84.0	84		F	10/15/2002	Vomiting, shaky, hyperventilation, resp 42, checked at ER and returned. Slept well, no ill effects next day.				Y					Y	10/15/2002	10/15/2002	0		OTH	OTH		NONE	NONE			1						1	Hyperventilation; Tremor; Vomiting	FLU3~SANOFI PASTEUR~U0886AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192321	11/01/2002	WA	28.0	28		F	10/28/2002	Fever, difficulty breathing, dizziness, weakness. High blood pressure-155/86, fast heart beat-pulse 98. Flusing of the face. I took a Zyrtec (antihistamine) and after 1/2 hour I started to feel better.									Y	10/25/2002	10/25/2002	0	NONE	OTH	PVT	NONE	NONE	NONE	Welt on site~Influenza (Seasonal) (Fluzone)~~27.00~In Patient		1						1	Asthenia; Blood pressure increased; Dizziness; Dyspnoea; Flushing; Heart rate increased; Pyrexia	FLU3~SANOFI PASTEUR~U0883AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192322	11/01/2002	CA	66.0	66		M	10/30/2002	Swollen innoculation site (about 4 diameter of discoloration and soreness). Chills (uncontrollable shivering) approximately 9 hours after the innoculation and lasting 18 hours. Fever and malaise keeping the patient in bed 3 full nights and days following the innoculation. (All adverse reactions from pneumonia shot.)									Y	10/15/2002	10/15/2002	0		OTH	OTH		None	None			1						1	Chills; Injection site swelling; Malaise; Pyrexia; Skin discolouration	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0192324	11/01/2002	ID	37.0	37		M	10/30/2002	Lg lump formed, high temp, streak running from injection site to inner arm.				Y					Y	10/25/2002	10/28/2002	3		PVT	PVT		NONE				1						1	Injection site discolouration; Pyrexia; Skin nodule	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0675M~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192325	11/01/2002	AL	35.0	35		F	10/10/2002	Patient took flu and pneumonia shot 10/03/02. Patient developed temperature of 104, malaise, and flu type symptoms. She was hospitalized at hospital on Saturday/Sunday and did not return to work until Wednesday 10/09/02 by MD release.				Y					Y	10/03/2002			UNK	UNK	UNK		NONE	NONE			1						1	Influenza like illness; Malaise; Pyrexia	FLU3~SANOFI PASTEUR~U0877AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0172H~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192326	11/01/2002	IA	63.0	61		F	10/17/2002	This is a time course of events that occurred after her influenza virus vaccine was administered 12/7/00. Pt was admitted into the clinic from 12/28/00, through 12/31/00, for extensive heart tests for extreme pain in chest and back. Nothing was found to be wrong with her heart. She returned home only to have further deterioration in her condition. 1/2/01, pt was admitted into hospital for loss of mobility as she could not walk at all. It started with drop foot and ended with total paralysis. She had no control over her extremities with excruciating pain in her back and chest. She was placed into intensive care after a full body MRI was done a few days after her admission. There she laid in pain, kept alive until the specialists visited approximately one week after admission. At this time it was determined by the specialists that they were treating an extreme case of Guillain-Barre Syndrome. The paralysis that had begun in her feet, crept up to the top of her head, leaving pt totally immobile but with excruciating pain. She remained in hospital until 3/19/01. 3/19/01, pt was admitted into hospital under the care of the original physician whose nurse had administered the influenza virus vaccine and pneumonia vax on 12/7/01. It was under the subsequent care of MD it was mentioned that the flu shot might have been the cause of reaction to the flu shot that was responsible for pt's Guillian-Barre Syndrome. It was also mentioned at that point that there was a vaccine adverse event reporting system available to injured parties. Pt was hospitalized at hospital until 4/19/01. Her hospitalization would have been longer had her private insurance not run out. Pt's physical therapy after hospitalization was continued within a month of her discharge down at the local swimming pool until June of 2001. All of the above has documentation behind it from the various hospitals, available upon request. Pt's current condition is confinement to a wheel chair and slight use of her hands and upper torso. Per 60 day follow up: Pt' records were released to VAERS on 11/22/2002. This is a time course of events that ocurred after her influenza virus was administered Dec. 7, 2000. Pt was admitted into the clinic, from Dec. 28, 2000, through Dec. 31, 2000, for extensive heart test for extreme pain in chest and back. Nothing was found to be wrong with her heart. She returned home only to have further deteioration in her condition. Jan. 2, 2001, Pt was admitted into hospital for loss of mobility as she could not walk at all. it started with drop foot and ended with total paralysis. She had no control over her extremities with excrucuating pain in her back and chest. She was placed into intensive care after a full body MRI was done a few days after her admission. There she laid in pain, kept alive until the specialist visted apprx. one week after admission. At this time it was determined by the specialists that they were treating an extreme case of Guillian Barre Syndrome. The paralysis that had begun in her feet, crept up to the top of herhead, leaving pt totally immobile but with excruciating pain. She remained in hospital until March 19, 2001.  March 19, 2001, pt was admitted into hospital under the care of MD, the original physician whose nurse had administered the influenza virus vaccine and pneumonia vax on Dec. 7, 2001. It was under the subsequent care of MD it was mentioned that the flu shot might have been the cause or reaction to the flu shot that was responsible for pt's Guillian- Barre Syndrome. It was also mentioned at that point that there was a VAERS available to injured parties. Pt was hospitalized at hospital until April 19, 2001. Her hospitalized would have been longer had her private insurance not run out. Pt's physical therapy after hospitalization was continued within a month of her discharged down at the local swimming pool until June of 2001. This report is the result of an inquiry to VAERS several weeks ago. All of the above has documentation behind it from the various hospital, available upon request. Annual follow up on 11/18/2003: Vaccine recipient did not recover from the adverse events that were reported for this vaccination.  Chronic weakness lower extremities wheel chair bound for life. Annual follow up on 11/25/2003: Vaccine recipient did not recover from the adverse events that were reported for this vaccination.  Chronic weakness lower extremities wheel chair bound for life.			Y		Y	111	Y	Y	N	12/07/2000	12/21/2000	14		PVT	OTH	Insulin-daibetes type II; HBP-medicine, cholesterol medicine	NONE	Diabetes- controlled blood pressure-controlled Cholesterol; neuropathy; hypothyroid			1						1	Abasia; Back pain; Chest pain; Depression; Guillain-Barre syndrome; Movement disorder; Paralysis	FLU3~SANOFI PASTEUR~U0399CA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~467415   exp 09~UNK~~~PNEUMO (PNU-IMUNE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0192327	11/01/2002	NV	71.0	71		F	10/30/2002	Redness/swelling/tenderness at injection site.									U	10/29/2002	10/29/2002	0	NONE	PVT	PVT	Levoxyl, Celebrex, Actonel, Imitrex, Prilosec		PCN, osteoporosis, hypothyroid, anemia			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4020023~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0192328	11/01/2002	MO	67.0	67		F	10/25/2002	Client taking antibiotic macrobia 100mg q 12 hrs; now c/o vomiting, decrease appetite, sluggish, aches/pains, decrease taste, soreness at injection site; redness in knee at site of old scar; states she is improving; encourage to see her physician; client's mother also reporting adverse effects.									U	10/15/2002	10/19/2002	4		PUB	PVT	UNK	NONE	NONE		MO2002035	1						1	Ageusia; Decreased appetite; Erythema; Injection site pain; Pain; Sluggishness; Vomiting	FLU3~SANOFI PASTEUR~U0886AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192329	11/01/2002	MO	86.0	86		F	10/25/2002	Move difficulty in mobilization/ambulation; swelling of hands bilaterally; more difficulty breathing; soreness at injection site; is taking now pain meds and alkaselzer; improving; client's daughter also reporting adverse effects.									U	10/15/2002	10/19/2002	4		PUB	PVT	UNK	NONE	UNK		MO2002036	1						1	Dyspnoea; Hypokinesia; Injection site pain; Oedema peripheral	FLU3~SANOFI PASTEUR~U0886AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192330	11/01/2002	TX	71.0	71		M	10/31/2002	Larger, hot, localized reaction at injection site right arm.				Y					Y	10/23/2002	10/24/2002	1	NONE	PVT	PVT		NONE				1						1	Injection site warmth	FLUX~UNKNOWN MANUFACTURER~V0G2AA~4~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1353L~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192331	11/01/2002	AZ	13.0	13		M	10/31/2002	Broke out in hives on Sat. itching all over.				Y					Y	10/17/2002	10/19/2002	2	NONE	PVT	PVT	Benadryl	NONE	Truncus ateriosus			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0885AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0008M~3~IM~RA~HEP B (RECOMBIVAX HB)~1|HEPA~MERCK & CO. INC.~0689M~1~IM~RA~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0192333	11/01/2002	AZ	63.0	63		F		Dizzy- pale- from 7pm No rx- resolved									Y	10/28/2002	10/30/2002	2		PVT	PVT	NONE	NONE	All Sulfa			1						1	Dizziness; Pallor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192334	11/01/2002	OH	76.0	76		M	10/31/2002	Dizzy after getting out of bedroom, fell to the floor- Severe case of diarrhea. No Rx									Y	10/30/2002	10/31/2002	1		OTH	PUB	Flutamide	NONE	Prostate CA			1						1	Diarrhoea; Dizziness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192337	11/01/2002	TX	66.0	66		F	10/31/2002	Large, hot localized allergic rxn at injection site left arm.				Y					Y	10/28/2002	10/29/2002	1		PVT	PVT	Vioxx, Premarin	NONE	Codeine only; Scleroderma, Raynaud's			1						1	Injection site reaction; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~U0982AA~4~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MM~MERCK & CO. INC.~0358M~UNK~~LA~MEASLES + MUMPS (MM-VAX)~1	USA	Emergency room visit	Influenza
0192338	11/01/2002	PA	55.0	55		F	10/28/2002	Approx. 5 hours post injection-fire red welts on anterior trunk, lasted approx 3 hours. 24 hours post injection, rash on arms, chest, back, no respiratory problems.									Y	10/23/2002	10/23/2002	0	NONE	OTH	PVT	Micordis, Cardizem CD, hydrochlorothiazide, Arista	NONE	Allergy-Nyquil, sulfa, nitrfuranderivatres, Dextremethoprom			1						1	Ascites; Erythema; Urticaria	FLU3~SANOFI PASTEUR~U0928AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192340	11/01/2002	MA		57		F	10/30/2002	The night of the flu vaccination, patient was up all night pacing and wheezing with shortness of breath with some difficulty breathing. Achy from head to tow. Afebrile.									Y	10/28/2002	10/28/2002	0	None	PUB	PUB	Zyrtec, Lovoxy	Slight cold afebrile	Allergies environmental			1						1	Dyspnoea; Pain; Sleep disorder; Wheezing	FLU3~SANOFI PASTEUR~U0879AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192342	11/01/2002	MO	54.0	53		F		Redness, swelling, soreness L deltoid Rocephin 500 mg x 1 dose 10/25/02.				Y					Y	10/24/2002	10/24/2002	0		PVT	PVT	Glucatrol, Lipitor	NONE	Demerol, PCN; diabetes, high cholesterol			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~EVANS VACCINES~30142GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0735M~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192468	11/01/2002	MD	57.0	57		F	11/01/2002	< 30 minutes after injection patient developed erythema of hands, face, back and within moments of examining her lungs, she became dizzy, Blood pressure was 80 palp. She was administered Benadryl 50mg IM and Epi 0.3cc subq. and while transferring her to a stretcher, she passed out momentarily. Rushed her to ER- they took over.			Y	Y					Y	11/01/2002	11/01/2002	0	pending- she's still in the ER  Pt reports flu shots for 15 + yrs with never a reaction	PVT	PVT	Motrin  - otherwise don't know her current meds	none	Von Willebrands			1						1	Anaphylactic reaction; Blood pressure increased; Dizziness; Erythema; Loss of consciousness	FLU3~SANOFI PASTEUR~UO949AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0192470	11/01/2002	NY	30.0	30		F	11/01/2002	It is not clear if this reaction was a direct result of the flu vaccine, but no other cause was found.  Patient developed significant swelling on the right side of her face on the next morning following administration of the vacccine.  She awoke with this swelling.  There were no other associated symptoms or complaints, and the swelling resolved without incidence throughout the day.  Patient was advised to seek consultation with the physician, however because her condition continued to improve, she did not see a physician.									Y	10/24/2002	10/25/2002	1		UNK	PVT	None	None	None			1						1	Face oedema	FLU3~SANOFI PASTEUR~U0931AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192471	11/01/2002	CA	63.0	63		F	11/01/2002	LEFT UPPER ARM, LARGE AREA AT DELTOID WARM TO TOUCH, ITCHES, SLIGHTLY SWOLLEN, RED									N	10/31/2002	10/31/2002	0	NONE	PVT	PVT	ESTRACE SYNTHROID AMIDEX	NONE	HYPOTHYROID HTN			1						1	Injection site erythema; Injection site hypersensitivity; Injection site oedema; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U0968AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192472	11/02/2002	PA	14.0	14		F	11/02/2002	Fiery red patch on upper left arm where pneumonia vaccine was administered. Also prominent swelling at infection site.  Pt was administered the vaccine on 10/31/02 at 11 am and started having symptoms at about 11 pm that night.  She has generalized body aches and a fever of 103.									N	10/31/2002	10/31/2002	0		PVT	PVT	Flovent 110mcg inhaler twice daily Albuterol inhaler 17g as needed Serevent 6.5g inhaler twice daily OTC Gas X 125 mg (simethicone) as needed OTC loperamide hydrochloride 2 to 4 mg)as needed Zyrtec 10 to 15mg daily	Chronic Asthma	Chronic Asthma; General Pollen Allergies	Nausea/Vomiting/Low Grade Fever~Hep B (no brand name)~1~3.00~In Patient		1						1	Injection site erythema; Injection site infection; Injection site oedema; Pain; Pyrexia; Injection site erythema; Injection site induration; Injection site warmth; Nausea; Oedema; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~IM~LA~PNEUMO (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U0934FA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0111M~1~IM~LA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0192476	11/02/2002	FL	51.0	51		F	11/02/2002	After 24 hrs:  severe burning throat all night, awoke with sore neck, sneezing. Arm felt like it was hit by a baseball bat.  The entire day, extreme exhaustion, heavy eyes, sore throat, mild runny nose.  That evening, sneezing, runny nose, coughing, scratchy, bright red throat.  Today, symptoms continue. Feel exhausted.  Prior to the vaccine, vibrantly healthy.										10/30/2002	10/31/2002	1		UNK	UNK	cenestin, prometrium (HRT) celebrex (knee injury)	Vibrant health.  No illnessness at all, not even a sniffle, for over a year.	Allergic to sulfa. Mild rash with some generic forms of penicillin (probably fillers). HRT.			1						1	Cough; Erythema; Eye disorder; Fatigue; Injection site pain; Mucosal inflammation; Pharyngolaryngeal pain; Rhinorrhoea; Sneezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192414	11/04/2002	WV	79.0	79		F	10/28/2002	Lightheaded, weakness, choking. Patient was put on oxygen in hospital					Y	3			Y	10/22/2002	10/22/2002	0	Blood work; EKG; X-rays	PVT	PVT						1						1	Asthenia; Choking; Dizziness	FLU3~EVANS VACCINES~E35712KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0192416	11/04/2002	AK	3.0	3		F	10/23/2002	Anaphylaxis-cardiovascular collapse 15 minutes after influenzae vaccine. Medical record states crying, cough, pale, limp, lethargic and loss of consciousness. msv				Y	Y	1			Y	10/19/2002	10/19/2002	0	NONE Medical records state abnormal lab tests. msv	OTH	PUB	NONE	NONE	NONE			1						1	Circulatory collapse; Cough; Hypotonia; Laboratory test abnormal; Lethargy; Pallor; Screaming; Syncope	FLU3~SANOFI PASTEUR~U0885AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0192417	11/04/2002	MA	66.0	65		F	10/17/2002	Angioedema involving entire arm. Began within 12 hours of shot. Needed oral prednisone to resolve. Medical records states headache, hypersenativity to flu A. msv			Y	Y					Y	10/15/2001	10/16/2001	1	Influenza antibodies type A-8, type B-<8.	PVT	OTH	Estsace; Astellin	NONE	Delayed large local-after Pneumovax	Argioedemas involving entire arm began within 12 hrs of shot~Pneumo (Pneumovax)~1~64.00~In Patient		1						1	Angioneurotic oedema; Headache; Hypersensitivity; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U0684AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0192424	11/04/2002	CA	53.0	53		M	02/18/2003	It was reported by a physician concerning a 53 year old male vaccinated with a dose of Fluzone SV 2002-2003 USP (lot number E31972GA) IM on 9/28/02. On 10/14/02, the patient developed sepsis. The physician also indicated that the patient developed pancytopenia due to polyclonal gammopathy, which required plasmaphoresis to remove the gamma globulin. The concomitant medications include Glucophage XR, Nizoral, Glucotrol XL, and Daypro. The lot number provided for Fluzone is not an valid lot number. Further information is requested. A 15-day follow up report received 02/20/2003 adds: From follow-up #1 correspondence received on 02/12/2003: The correct lot number for Fluzone is U0981AA, not E31972CA as previously reported. The pt's name and responsible physician's name was provided. No additional information was received. A 15-day follow up report received 9/30/2003 adds: From additional info received on 09/12/2003 from the reporting physician, it was reported that the duration of the adverse event lasted one month and that the pt has fully recovered. Reportedly, no hospital records or lab work could be obtained at this time. No further info is anticipated, this case is considered closed.			Y	Y					N	09/28/2002	10/14/2002	16	Pancytopenia due to polyclonal gammopathy	OTH	OTH	Daypro, Glucophage XR, Glucotrol XL, Nizoral		NONE		U200200881	1						1	Pancytopenia; Sepsis	FLU3~SANOFI PASTEUR~U0981AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0192434	11/04/2002	WA	45.0	45		M	10/24/2002	12PM Pain at site, neck, back, chest - dyspnea. Fever 102, confused, weakness on left, nausea.									Y	10/24/2002	10/24/2002	0	None	OTH	PVT	Norvasc, Atenolol	None	Hypertension			1						1	Back pain; Chest pain; Confusional state; Dyspnoea; Hemiparesis; Injection site pain; Nausea; Neck pain; Pyrexia	FLU3~EVANS VACCINES~E33402HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1161L~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192438	11/04/2002	VA	43.0	43		F	10/24/2002	Fever 101.5, nausea, chills, arm red, swollen and hot.									Y	10/18/2002	10/21/2002	3	None	PVT	PVT		Clogged ear	IBS, Chronic eustacian tube dysfunction, Seasonal allergies			1						1	Chills; Erythema; Feeling hot; Nausea; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U0931AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192439	11/04/2002	FL	81.0	81		F	07/29/2002	it is now almost a year since the health department offered influenza and pneumonia shots. I received mine on 11/08/01. I was a healthy person who walked 2 miles a day, strong back, strong bones and muscles. Since the shots, I've been crippled with sciatica up to mid-September of this year, and left with a weakened back forever. The shots were particularly painful. For two nights, I ran a fever, and for a week, could not turn in bed for the pain of rolling onto either shoulder. Within two to three weeks, my feet felt peculiar, as if with a circulation problem. A daily two-mile walk did not clear the sensation. Then something was starting to happen in my lower back. There started to be a twinge in the lumbar region with every step. I attributed it to the vaccine shots, and trusted it to wear off. But it got worse. As luck would have it, in March this year I was treated to a massage by a licensed physical therapist. She believed I had sciatica. By then, I was having trouble getting out of bed and trying to walk, and could only do so by bending over and limping onto my good right leg. For seven months I could sleep only on my right side in the fetal position. Frequency became a problem, not only as if an internal pressure or swelling were the cause, but the sheer pain of trying to get to the bathroom, sometimes crawling, three or four times a night was a nightmare. By May, and the next several months, I was crippled with pain in a very limited life. A neighborhood doctor prescribed Darvocet and rest. I did not open the bottle. A friend insisted that I have chelation. Another doctor was assigning me to get an epidural cortisone shot. Instead, I went to a health food store to ask if there was a product able to remove toxins from the body. A jar of Liverclean and another of ecchinacea was suggested. I asked my doctor to assign me to a physical therapy clinic where the first two weeks in September consisted of electrical stimulation and heat. These did nothing. I managed to walk in, but departed, limping. I asked to use the machines, especially the stationary bicycles. Miraculously, the sciatica in my left leg was gone in two weeks after doing these work outs and dosing with the detox formula. As an uneducated guess, I suspect the vicious neurotoxin, mercury, in the two vaccine shots as having gone directly to the nerve center and attacking the soft tissue of the L4-L5 vertebrae (shown in MRI) in my spine. The best response from three doctors, when asked about mercury, was that I must be allergic to mercury. Even though I'm free of sciatica, there is permanent damage done to my spine. I now must move cautiously, carefully load and unload groceries, get in or out of the car, avoiding twisting while bending, or pushing a sweeper, mop , or vacuuming. Walking at my old pace is no longer possible, and standing for any length of time begins to hurt. I am grateful, however, for finally being able to sleep on either my left or right sides.									N	11/08/2001	11/09/2001	1	MRI; Hip X-Ray - Normal	PUB	PUB	None	None	None	Flu-like symptoms~Influenza (Seasonal) (no brand name)~~59.00~In Patient		1						1	Difficulty in walking; Hypotonia; Pyrexia	FLU3~SANOFI PASTEUR~U0690AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1448K~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192440	11/04/2002	IN	6.0	6		M	10/25/2002	Anaphylactoid purpura - Patient received influenza vaccine on 10/14. He began with abdominal pain 10/20. He progressed to joint swelling and pain on 10/23. On night of 10/24 - purpura observed bottom of feet.				Y					Y	10/14/2002	10/20/2002	6	ESR - 18; CNUM 12 WNL	PVT	PVT	Zyrtec, Rhinocort	None	Allergic Rhinitis			1						1	Abdominal pain; Arthralgia; Joint swelling; Purpura	FLU3~PFIZER\WYETH~4020003~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0192441	11/04/2002	WA	61.0	61		F	10/24/2002	Breathing problems 24 hours after injection. Peak flow ok. I felt as if there was a coating on my lungs which made breathing more difficult. It took 2 weeks to feel ok.									Y	10/08/2002	10/09/2002	1	None	PUB	PVT	HRT; Vitamin, Serevent, Nasacort, Allegra, Covera, Vioxx	None	Respiratory allergies, sulfa allergies, Asthma	Sore site~Influenza (Seasonal) (no brand name)~~55.00~In Patient|~Smallpox (Dryvax)~~2.00~In Sibling		1						1	Dyspnoea	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192442	11/04/2002	NY	45.0	45		F	10/23/2002	Spot sore on injection. Later in PM, felt very sore. Upon exam saw reddened area felt hot. Put ice pack on. Reported in AM at work.									Y	10/22/2002	10/22/2002	0		PUB	PUB		None	HBP			1						1	Feeling hot; Injection site erythema; Injection site pain	FLU3~PFIZER\WYETH~4020027~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0192444	11/04/2002	MO	19.0	19		F	10/24/2002	Warm, fine, itchy maculopapular rashes all over body, extremities and face two days after flu vaccine was received. (1st time received)				Y					Y	10/21/2002	10/23/2002	2		PUB	PVT	None	None	None			1						1	Feeling hot; Pruritus; Rash maculo-papular	FLU3~SANOFI PASTEUR~U0924DA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192446	11/04/2002	TN	79.0	79		F	10/24/2002	Next morning after injection the site was red, sore and beginning to swell and continued being more painful throughout the day. Was seen by MD and was given Allegra and pain med. Feels much better 10/25/02 today. Arm, shoulder, and neck pain.				Y					Y	10/22/2002	10/23/2002	1		OTH	PVT		NONE	NONE			1						1	Arthralgia; Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U0886AA~7+~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192456	11/04/2002	WI	48.0	47		M	10/28/2002	On 10/25/02 employee received flu shot in ER per above mentioned student under the guidance above listed Rn with reportedly correct technique and with sterile procedure. On 10/28/02 developed blister at injection site with redness and soreness. Emp had area drained in the ER and the next day debrided. No fever or other adverse reactions noted or reported by employee.				Y					Y	10/25/2002	10/26/2002	1	NONE	PVT	PVT	UNK	NONE	NKA			1						1	Injection site erythema; Injection site pain; Injection site vesicles	FLU3~SANOFI PASTEUR~U0958AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192457	11/04/2002	MI	37.0	37		F	10/25/2002	Tenderness-blotchy rash around site L arm-dry throat, nausea. Discontinues red plaques, tender, not itchy. Shoulder aches.									U	10/23/2002	10/24/2002	1		OTH	PUB	Rebif		Multiple sclerosis			1						1	Dry throat; Injection site pain; Injection site rash; Nausea; Pain; Rash macular	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0192458	11/04/2002	IN	58.0	58		M	10/21/2002	58 year old white male who received Influenza vaccine 10 days prior who developed non-painful swelling of left ankle that has persisted. pt has had influenza vaccine from various manufacturers without side effects. Non painful arthritis. Probably post infections. As per acknowledgement letter: arthritis resolved on own after 6 weeks									U	10/08/2002	10/08/2002	0	CRP normal, mic an, RF and ANA normal	UNK	UNK	Zocor, Lotral		BP high and cholesterol			1						1	Arthritis; Injection site oedema	FLU3~SANOFI PASTEUR~U0910AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192459	11/04/2002	TX	47.0	47		F	10/29/2002	10/24/02-sluggish. 10/25/02-weak, fever (Motrin). Headaches, chills, cold sweat, back ache, and sore throat, no energy.									U	10/23/2002	10/24/2002	1		PUB	UNK		Heart and lung	Sarcoibosis	~Influenza (Seasonal) (no brand name)~1~45.00~In Patient		1						1	Asthenia; Back pain; Chills; Headache; Hyperhidrosis; Pharyngolaryngeal pain; Pyrexia; Sluggishness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192464	11/04/2002	OR	83.0	83		F		R arm swelling, red, pain for less than or equal to 48 hrs. Tx: ice no md.									Y	10/25/2002	10/25/2002	0		PUB	PUB		NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0192465	11/04/2002	MA	20.0	20		F	10/29/2002	Pt received flu vaccine on 10/21/02. On 10/24/02 the pt returned to the clinic complaining of a headache and dizziness, room was spinning and loss of concentration.									U	10/21/2002	10/22/2002	1		OTH	OTH		NONE	Lupus, fibromyalgia, arthritis, spondyloarthropathy			1						1	Disturbance in attention; Dizziness; Headache	FLU3~SANOFI PASTEUR~U0879AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192520	11/04/2002	FL	31.0	31		F	11/04/2002	beginning 2 days after vaccination - experienced sore throat, hoarseness, labored breathing. The follow up received on 4/21/03 states condition eventually diagnosed as bronchitis with sinusitis.										10/30/2002	11/01/2002	2		PVT	PVT	no	no	sulfa drug allergy			1						1	Bronchitis; Dysphonia; Dyspnoea; Pharyngolaryngeal pain; Sinusitis	FLUX~UNKNOWN MANUFACTURER~E32072GA~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192521	11/04/2002	PA	4.0	4		M	11/04/2002	10/27 swelling of arm slightly below site of vaccine administration; 10/28 sent to ED for worsening symptom; 10/31 seen in Primary Care Center for f/u ED visit for cellulitis L arm, improving; placed on keflex 250 mg for 10 days at time of ED visit				Y					Y	10/26/2002	10/27/2002	1	none	PVT	UNK	albuterol prn	none	multiple otitis, sinusitis, RAD, seasonal allergies			1						1	Cellulitis; Oedema	FLU3~PFIZER\WYETH~4020016~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0192523	11/04/2002	PA	42.0	42		F	11/04/2002	chills, fever, diarrhea, nausea, headache				Y					Y	10/23/2002	10/23/2002	0	None	PUB	PVT	Immuran, azulfidine, atenolol, HCTZ, Protonix, Multivitamin	None	Ulcerative colitis			1						1	Chills; Diarrhoea; Headache; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~U0969AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192524	11/04/2002	AK	36.0	36		M	11/04/2002	Headache developed by 2 PM on 10-22-02.Progressively feeling worse and developed stomacheache with diarrhea by that evening. Missed the subsequent 2 days of work with diarrhea a couple times per day and headache that persisted, pressure in ears, sinus, tightness in throat, no SOB. Use of Albuterol inhaler relieved some of tightness in throat and sinus pressure.									Y	10/22/2002	10/22/2002	0		PUB	PUB	Zertec 10 mg QD (Had taken the night before)	Specifically feeling well until after immunization.	Allergies to dust/pollens per patient. No allergy testing has been done.			1						1	Abdominal pain upper; Diarrhoea; Headache; Sensation of pressure; Sinusitis; Throat tightness	FLU3~SANOFI PASTEUR~UO885AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192525	11/04/2002	NY	47.0	47		F	11/04/2002	Sever local reaction.  Arm in which shot was administered quickly ballooned up and turned bright red over a patch approximately 8 inches in length.  Extreme pain and restricted mobility for two days, accompanied by unremitting severe headache and dizziness.				Y					Y	11/01/2002	11/01/2002	0		UNK	UNK						1						1	Dizziness; Erythema; Headache; Injection site reaction; Joint range of motion decreased; Oedema; Pain	FLU3~SANOFI PASTEUR~Aventis UO933AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192526	11/04/2002	ME	12.0	12		F	11/04/2002	Pt developed a single 6mm wheal w/ surrounding erythema between eyebrows 15 /p flu vax given, w/o response @ inj site w/ sl upper face flushing. Pt denied difficulty breating & w/o observed SOB. 1 hour post inj pt exhibited 2 additional facial (approx 15mm ea) & one lower back area of erythema (25mm)w/ facial flushing sl increased. Pt continued to deny difficulty breating. Benadryl 25 mg po given w/ decrease in sym. Pt discharged to home w/ mother w/ instructions to call w/ questions or if symptoms return.									U	11/04/2002	11/04/2002	0		UNK	PUB	Ranitidine HCL 150 mg po BID	Rt ear pain	Allergies: Ceclor, Codeine, S/P Appendectomy, Hx irregular heart rate			1						1	Dyspnoea; Erythema	FLU3~SANOFI PASTEUR~U0904CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192527	11/04/2002	WI	44.0	44		F	11/04/2002	RECEIVED FLU VACCINE AT 1515 ON 10/27/02, AT APPR 2320 ON 10/27/02 WOKE UP WITH CHILLS FEVER AND BODY ACHES AND PAINS, LASTED THRU 10/29/02									Y	10/27/2002	10/27/2002	0		PVT	PVT		NO	NONE			1						1	Chills; Pain; Pyrexia	FLU3~SANOFI PASTEUR~UO888AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192528	11/04/2002	NM	47.0	47		F	11/04/2002	Flu shot given RUA and covered with Band Aid. When Band Aid removed at bedtime, employee noted a wheal, approximately 10 mm, like a positive TB skin test.  Subsided by next morning.									Y	10/03/2002	10/03/2002	0	None	PVT	UNK		None	Allergy to Amoxicillin.  Seasonal allergies -- spring.			1						1	Urticaria	FLU3~EVANS VACCINES~E34682HA~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0192529	11/04/2002	CA	52.0	52		M	11/04/2002	Received at approximately 12 noon on November 2, 2002.  Approximately 14 hours later had shaking chills with a temperature of 100 degrees (oral).  In AM, took shower with a resulting increase in pulse to 120 bpm.  Achey all over and a feeling of exhaustion.  Chills again approximately 34 hours after immunization.   AM of 2nd day, November 4th,  felt ok - no fever, chills or achiness.  Left arm has a raised red area approximately 2 inches in circumference.									Y	11/02/2002	11/03/2002	1	none	PVT	UNK	Plavix, aspirin, Niaspan, Lipitor, Vasoheal, Paxil, Lisinipril, Atenolol	none	hypertension, athrosclerosis			1						1	Chills; Fatigue; Heart rate increased; Pain; Pyrexia; Rash erythematous	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192531	11/04/2002	WY	27.0	27		F	11/04/2002	Painful injected area aroun injection g-te 8cm x 8cm.  Is taking bendryl									Y	11/02/2002	11/02/2002	0	None	MIL	MIL		None	None			1						1	Injection site pain	FLU3~PFIZER\WYETH~402003E~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0192532	11/04/2002	NC	52.0	52		M	11/04/2002	Patient became very pale, with chills and weakness, some tingling in arms.  After calling doctor, patient ingested one Benadryl table, and within 30 minutes felt normal. As per follow up: There is no employee by that name. We have never completed a VAERS form.									Y	10/11/2002	10/11/2002	0		PUB	PUB						1						1	Asthenia; Chills; Pallor; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192090	11/05/2002	FL	72.0	71		F	10/29/2002	103 temp x 5 days, achiness in R arm and R side of neck, nausea, loss of appetite, weakness, starting feeling neck pain and stiffness on 10/21/02 with fever starting on 23rd. Had flew 2 days prior on the 15th. Has hep C-was on interferon last year.									Y	10/17/2002	10/21/2002	4	Taken for chest x-ray 10/29/02	OTH	PVT	NONE		NONE			1						2	Back pain; Bone pain; Ear pain; Hyperhidrosis; Influenza like illness; Pyrexia; Anorexia; Asthenia; Musculoskeletal stiffness; Nausea; Neck pain; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~E34672HA~3~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0192477	11/05/2002	WA	22.0	22		F	11/01/2002	Pt died of distributive shock and multisystem organ failure on 10/26/02.	Y	10/26/2002							N	10/17/2002	10/21/2002	4	Pathelogy studies at AF17 now	MIL	MIL	NONE	NONE	NONE			1						1	Multi-organ failure; Shock	FLU3~SANOFI PASTEUR~U0983AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|YF~CONNAUGHT LABORATORIES~U0253AA~1~SC~~YELLOW FEVER (YF-VAX)~1	USA	Results in Death	Influenza
0192503	11/05/2002	TX	55.0	55		F	10/30/2002	Pounding severe headache, intractable vomiting, high blood pressure, high respiration rate, high heart rate. Needing hospitalization 2 days.				Y	Y	2			Y	10/09/2002	10/11/2002	2	Decrease K, dehydration	PUB	PUB	None	None	None			1						1	Dehydration; Headache; Heart rate increased; Hypertension; Respiratory rate increased; Vomiting	FLU3~SANOFI PASTEUR~U0913AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0192507	11/05/2002	CA	10.0	10		F	10/17/2002	10/15 Stomach cramp, vomiting, diarrhea. 10/16 Fever, pain at injection site. left shoulder redness, swelling edema. 10/17 hospitalized and treated with APAP. rehydration and ABX.					Y				Y	10/15/2002	10/15/2002	0	C-Reactive protein, Blood/Urine culture, CBC WNL	PUB	PUB	Prednisone, Valcite, Prograf	None	NKA, Renal transplant			1						1	Abdominal pain; Diarrhoea; Erythema; Injection site pain; Oedema; Pyrexia; Swelling; Vomiting	FLU3~SANOFI PASTEUR~U0968AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0541M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0192508	11/05/2002	MN	73.0	73		F	10/30/2002	To ED 7 hrs post vaccine with muscle aches, spasms, chills, nausea. Developed R shoulder/upper arm cellulitis (location of vaccine), L3-4 vertebral osteomyelitis due to group B strep septicemia.				Y	Y	13	Y		Y	10/06/2002	10/06/2002	0	10/8 WBC 34,000 with L shift. 10/8 blood culture group B beta strep x 2 cultures.	OTH	UNK	Premarin, Synthroid, Albuterol, Advair, Nasonex, Zyrtec	None	Hypothyroid, allergic rhinitis, chronic sinusitis, asthma, osteoarthritis.			1						1	Cellulitis; Chills; Injection site reaction; Muscle spasms; Myalgia; Nausea; Osteomyelitis; Sepsis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0192519	11/05/2002	TX	0.5	0	.5	F	10/23/2002	Severe urticaria starting within 2 hrs. Treated with oral Benadryl and Prednisone.									Y	10/15/2002	10/15/2002	0	10/23/2002 tested for egg allergy	PVT	UNK	NONE	Mild nasal congestion	NONE			1						1	Hypersensitivity; Urticaria	DTAP~SANOFI PASTEUR~U0543LA~3~~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U0913AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~U1233~3~~RL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~485978~3~~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0192533	11/05/2002	CA	9.0	9		M	11/05/2002	Rash on torso, especially on lower back. Small red pimples.										11/02/2002	11/04/2002	2		PUB	UNK	n/a	n/a	none			1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~3~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192537	11/05/2002	CA	2.0	2	.2	M	10/30/2002	After patient left clinic, patient was drowsy (he was in his stroller, the while time; the reaction was noted by mom). He was turned to one side as if he was limp. After 2 hours, he was his old self. Patient came back to the clinic. He was fine.				Y					Y	10/30/2002	10/30/2002	0		PVT	OTH	UFC	URI	Hx of RAD			1						1	Hypotonia; Somnolence	FLU3~SANOFI PASTEUR~U0938AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SMITHKLINE BEECHAM~5346A2~4~~RL~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0192539	11/05/2002	TN	76.0	76		F	10/14/2002	Patient states around 14:30 on day of flu shot, patient stated she became dizzy, unable to walk, fever, chills, and vomiting. Had a HA, pain down right arm, and lower back pain. Could not lift arms. Had flu shot in left arm. Stayed in recliner most of the day; took Tylenol and drank green tea. Felt some better the next day. Still today, feels achy especially in lower back, HA, and sick to her stomach. Patient advised to see private physician for evaluation. Seen local physician PM Friday on 10/14/02. Diagnosed with bladder infection. Treated with antibiotics. To return to see doctor for follow up on 10/22/2002.				Y					N	10/11/2002	10/11/2002	0	Urine specimen	PUB	PUB	Timpotic eye drops 1 drop BID right eye. Centrum Silver vitamin daily.	None	None except glaucoma right eye		TN02033	1						1	Back pain; Chills; Cystitis; Difficulty in walking; Dizziness; Headache; Joint range of motion decreased; Nausea; Pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U0925AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192540	11/05/2002	NM	64.0	64		F	10/25/2002	Flu vaccine given 10/21/2002. Noticed rash this am 10/25/2002. Rash on hand, face, chest, arms, and hands. Rash was red and not well defined. States rash itches, but does not burn and is not painful. Denies dyspnea, blurred vision or change in mortal status or fever/chills.									Y	10/21/2002	10/25/2002	4	Referred to PMD for follow-up	PUB	UNK	Humulin Humolog, Pravachol, Altase, Hot3, Celbrex, Pravacid, Metoclotrimide	NONE	Diabetic, Right hip dysplasia due to polio.		NM100102	1						1	Erythema; Rash; Rash pruritic	FLU3~PFIZER\WYETH~4020008~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0192541	11/05/2002	UT	47.0	47		F	10/30/2002	Immunized 10/28/02 08:30. That evening soreness of injection site with lump. Next morning, sore and redness with increase in size over next 24 hours. Felt warm to touch on 10/30/02--size of swelling diminshing; redness diminishing and discomfort increasing.									Y	10/28/2002	10/28/2002	0	None	OTH	OTH	None	None	None			1						1	Feeling hot; Injection site erythema; Injection site mass; Injection site pain	FLU3~PFIZER\WYETH~4020015~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0192542	11/05/2002	OR	16.0	15		F	10/29/2002	2 days post vaccination (flu) red rash down left arm; minimal swelling; no warmth.									Y	10/23/2002	10/25/2002	2		PVT	PVT		None	None			1						1	Erythema; Rash; Swelling	FLU3~PFIZER\WYETH~402020~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0192544	11/05/2002	RI	50.0	50		M	10/24/2002	Hives, itching and red rash									Y	10/22/2002	10/23/2002	1	NONE	UNK	PVT	NONE	NONE	NONE			1						1	Erythema; Pruritus; Rash; Urticaria	FLU3~PFIZER\WYETH~400234~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0192545	11/05/2002	FL	24.0	24		F	10/24/2002	At approx. 1pm, client received Flu one vaccine. 5cc-- 2 hours later came to report itching all over.				Y					U	10/24/2002	10/24/2002	0		OTH	OTH	NONE	NONE	NONE			1						1	Pruritus	FLUX~UNKNOWN MANUFACTURER~U0879AA~2~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0192546	11/05/2002	PA	41.0	41		F	10/30/2002	Pt is an employee and had flu vaccine administered. She then came to employee health with complaints of itchiness, dizziness, nausea, headache within 15 minutes of receiving vaccine. She then was noted to have hives and large wheals reaction at left deltoid region.				Y					U	10/30/2002	10/30/2002	0	NONE	OTH	OTH	NONE		NONE			1						1	Dizziness; Headache; Nausea; Pruritus; Urticaria	FLU3~PFIZER\WYETH~4020029~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0192547	11/05/2002	CA	32.0	31		F	10/29/2002	Immediate headache followed by chills and low grade temperature.				Y					Y	10/25/2002	10/25/2002	0	Normal EKG, Urine test in ER	PVT	PVT		NONE	NONE			1						1	Headache; Pyrexia	FLU3~SANOFI PASTEUR~U0944AA  exp 06~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192548	11/05/2002	CA	38.0	38		F	10/31/2002	Severe edema of surrounding skin. 10 cm area of erythema and edema									Y	10/15/2002	10/15/2002	0	NONE	PVT	PVT		Diarrhea	Codeine/ Day Pro,  has seasonal asthma	erythema and edema at site~Tetanus Toxoid (no brand name)~~0.00~In Patient		1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U0875AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192550	11/05/2002	FL	75.0	75		F	10/28/2002	Reported fever (100.9), chills, aches, cough, hives on right arm and upper abdomen. Symptoms over period of approximately 36 hours. Treatment consisted of bed rest, anacin, fluids. Vaccine information not available as the vaccine was not administered by reporter.									Y	10/22/2002	10/22/2002	0	None	OTH	OTH	Methotrexate; Supartz, Prednisone	Giant Cell Arteritis	Giant Cell Arteritis			1						1	Chills; Cough; Pain; Pyrexia; Urticaria	BCG~SANOFI PASTEUR~~UNK~~~BCG (MYCOBAX)~1|FLU3~SANOFI PASTEUR~U0911BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1353L~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192551	11/05/2002	FL	61.0	61		F	10/31/2002	Fever, cold like symptoms, redness on right arm site.									N	10/29/2002	10/31/2002	2	None	PVT	PVT		None				1						1	Injection site erythema; Pharyngitis; Pyrexia; Rhinitis	FLU3~SANOFI PASTEUR~U0905FA~UNK~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0735M~UNK~~RL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192552	11/05/2002	GA	43.0	43		F	11/01/2002	Left arm pain started day of vaccine; symptoms diarrhea, vomiting, cough. Left arm was red, swollen, indurated. Patient treated with IV--normal saine, Phenergan, and Rocephin.				Y					Y	10/30/2002	10/30/2002	0	CBC elevated WBC 13.8	PVT	PVT	Coumadin, Prevacid, Celebrex, Lithium, Neurontin, Allegra, Zocor, Lasix, Tenormon	Cold symptoms	Hx of DVT, Pulmonary Embolism, Allergies, BiPolar, GERD, CAD			1						1	Cough; Diarrhoea; Injection site erythema; Injection site induration; Injection site swelling; Pain; Vomiting; White blood cell count increased	FLU3~SANOFI PASTEUR~U0925AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0923L~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192554	11/05/2002	TN		79		F	11/01/2002	Flu vaccine administered 10/16/02 in the office. Approximately 40 minutes to 1 hour after injection, patient presents with severe chills, SOB, nausea, shaking. Patient admitted to hospital immediately.					Y				Y	10/16/2002	10/16/2002	0	None	PVT	PVT	Coreg 2.5 mg PO BID, Catapress TTs 2mg per week, Preparation H PRN, Baby ASA QD, Multi vitamin QD, Oscal PO QD, Miacalcin nose spray, spary alt nostril QD, Albutrol nebulizer PRN, Azamacort MDI PRN, Combivent MDI PRN, Lasix 20mg PO QD, Prav	None	Allergic to PCN, Hypertention, Benign positional vertigo, Asthma, severe copp, coronary artery disease status post CABG, osteoporosis, degenerative joint disease, GERD, chronic renal insufficiency, low back pain, peripheral vascular disease, diet controlled diabetes			1						1	Chills; Dyspnoea; Nausea; Tremor	FLU3~SANOFI PASTEUR~U0886AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0192556	11/05/2002	MD	76.0	76		F	10/30/2002	Above child received a flu vaccine injection on 10/23/02. On PM 10/24/2002 had sharp pain in left arm and noticed swelling and left arm became discolored from shoulder to elbow. Was seen by MD on 10/25/02 and 10/26/02.				Y					N	10/23/2002	10/24/2002	1		OTH	OTH	Baby ASA QD; Provera; Lanoxin; Multi-vitamins	Atrial Fib	Atrial Fib			1						1	Injection site swelling; Pain; Skin discolouration	FLU3~PFIZER\WYETH~4020017~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0192557	11/05/2002	TN	46.0	45		F	11/01/2002	Left arm got sore night of injection, by next morning 10/31/02, had throbbing pain up into neck, took Tylenol for 4 hours and took Benadryl 10/31/02. Arm remains sore 11/01/02 but pain in neck gone.									Y	10/30/2002	10/30/2002	0	None	OTH	OTH	Celexis, Premarin, Levaquin	UTI	None			1						1	Injection site pain; Neck pain	FLU3~SANOFI PASTEUR~U0955AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192558	11/05/2002	MN	40.0	40		F	11/01/2002	Patient stated she became flushed after injection. She developed abdominal cramps, diarrhea, and dizziness. Throughout the evening into the next day the patient developed nausea, vomiting, fever, malaise. She stated she is now experiencing itching (generalized and a raised rash). Referred to her family physician. Patient states she had a problem with the flu shot in the past.										10/30/2002	10/30/2002	0		UNK	PUB		None				1						1	Abdominal pain; Diarrhoea; Dizziness; Flushing; Malaise; Nausea; Pruritus; Pyrexia; Rash	FLU3~PFIZER\WYETH~A820033~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0192561	11/05/2002	SD	72.0	72		F	10/31/2002	30 minutes after Pneumovax was given in right deltoid and flu vaccine was given in forearm, she had swelling and redness in the forearm injection site. She felt all right. Ten to 12 hours later, she had dry heaves and intermittent chest pain. No shortness of breath. Did have chills. Hardness and redness at injection sites persisted as of the next day. We had given 1/2 dose of flu shot IM on advice from her allergist.									Y	10/15/2002	10/15/2002	0	History of positive skin test for egg allergy but no clinical inolerance to eggs.	PVT	PVT	Synthroid, Lipitor, ASA, Mulit-vitamin		Latex allergy, nuts/mango/mold allergy. Prinzmetal's angina			1						1	Chest pain; Dyspnoea; Injection site erythema; Injection site induration; Injection site swelling; Retching	FLU3~EVANS VACCINES~E33902HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1161L~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192562	11/05/2002	MA	70.0	70		M	10/31/2002	Patient had chills, fever, felt not well on Thursday night. 10/24/02; went to concert and home to bed. Friday felt uckey, 10/25/02. Saturday 10/26, upper right arm, red; called clinic and sent to see MD. Placed on IV Cephalexin and 10/27 placed on Cephalexin 500 PO QID.				Y					Y	10/24/2002	10/24/2002	0		PUB	PUB						1						1	Chills; Erythema; Malaise; Pyrexia	FLU3~SANOFI PASTEUR~U0879AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0923L~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192563	11/05/2002	OH	78.0	78		F		Husband notified agency that patient admitted to hospital on 10/05/02 with CHF. Patient has history of CHF, COPD, asthma, IDDM. Patient's husband feels the only thing different was that the patient received a flu shot on 10/04/2002. The discharge summary states chronic obstructive pulmonary disease.					Y	5			U	10/04/2002	10/05/2002	1		OTH	PVT	Celexa, Impur, Lescol XL, Lopressor, Diazepam, Albuterol, Hydyalazine, Glucophage, Oxygen, K-dur, Vitamin C	CHF	CHF, Asthma, COPD, Allergy, Diabetic, Depression, hypertension, anxiety, CVA, coronary artery disease		OH0038	1						1	Cardiac failure congestive; Lung disorder	FLU3~EVANS VACCINES~E32072GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0192564	11/05/2002	OH	76.0	76		F	10/18/2002	2 days after patient received a flu shot, she developed a 3x3 red, hot, hard area at injection site. Patient also developed redness below her D.D. and right breast. Family was instructed to call physician.									Y	10/10/2002	10/12/2002	2		OTH	PVT	Synthroid, Vitamin C, Zoloft, Mobic, Zantac, Neurotin, Elavil, Lipitor, Tylenol, Zanaflex	CVA	CVA, Allergy-Penicillin		OH0039	1						1	Feeling hot; Injection site erythema; Injection site induration	FLU3~EVANS VACCINES~E32072GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0192565	11/05/2002	MD	79.0	79		F	11/01/2002	Lost hearing in right ear, severe imbalance problem. treated at hospital in Er 10/14/2002 by ear, nose, and throat specialist 10/21/2002. still suffering cannot walk without losing balance.				Y					N	10/05/2002	10/06/2002	1	Catscan(head) EKG, Hearing test	OTH	PUB	NONE	NONE	High blood pressure, breast cancer, depression			1						1	Difficulty in walking; Hypoacusis	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0192566	11/05/2002	MT		28		F	10/30/2002	Within 20 minutes of injection, patient was itching, swollen and had 10cm.									Y	10/23/2002	10/23/2002	0		OTH	UNK	Prilosec, Effexor	None	NKA			1						1	Pruritus; Swelling	FLU3~SANOFI PASTEUR~U0875AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192567	11/05/2002	MO	67.0	67		F	10/28/2002	Client reports hives on face, neck, stomach with severe itching. Spoke with client on phone who stated the itching. Referred to PMD. Client stated ha received flu vaccine of year with no prior allergies.										10/25/2002	10/27/2002	2		PUB	UNK						1						1	Pruritus; Urticaria	FLU3~PFIZER\WYETH~4020027~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0192568	11/05/2002	MT	63.0	63		F	10/18/2002	Patient complained of lump, swelling, redness, itching at injection site.									Y	10/07/2002	10/07/2002	0	None	PVT	PVT	Synthroid		Allergic: PCN, Bactrim; Hypothyroidism			1						1	Injection site erythema; Injection site hypersensitivity; Injection site mass; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U0880AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192569	11/05/2002	SC	80.0	80		F	10/27/2002	In early evening of vaccination date pt suffered chills and shaking. took hot shower before retiring, then suffered high fever. Took buffered aspirin and still had 103 degree fever in morning plus nausea. MD advised Tylenol liquids plus anti-nausea (Promethazine 25mg). Pt remained in bed past noon when fever receded to 89.7 degrees. By Sun am pt was near normal and able to consume some food.									Y	10/25/2002	10/25/2002	0		PUB	UNK		NONE	NONE			1						1	Chills; Nausea; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192570	11/05/2002	NY	44.0	44		F	10/27/2002	Patient had dime size area of redness within one hour of injection. 24 hours later was 7cm diameter with warmth; no induration.										10/24/2002	10/24/2002	0		PUB	OTH		none	Allergy to latex			1						1	Feeling hot; Injection site erythema	FLU3~SANOFI PASTEUR~U0910AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192571	11/05/2002	NY	22.0	22		F	10/29/2002	Left deltoid reddened, swollen, and pain just hours after flu vaccine.									N	10/28/2002	10/28/2002	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~EVANS VACCINES~E30122FA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0192572	11/05/2002	DC	26.0	26		F	10/19/2002	Vasovagal episode after receiving influenza and PPD. Referred to ED and released to duty.				Y					Y	10/19/2002	10/19/2002	0	Negative HCG; PPD	MIL	MIL		None	None			1						1	Syncope vasovagal	FLU3~SANOFI PASTEUR~U0880AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192573	11/05/2002	OR	78.0	78		F	10/29/2002	Acute swelling, erythema, tenderness of right deltoid exquisite tenderness with moderate erythema, swelling				Y					Y	10/24/2002	10/24/2002	0	NONE	PVT	PVT	Vioxx 25mg, Deltrol, Norvas 5mg, Diovan, Iron pill	NONE	Spinal stenosis, HTN, Hx CVA, Myelodysplasia			1						1	Injection site erythema; Injection site oedema; Tenderness	FLU3~SANOFI PASTEUR~U0872AB~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192574	11/05/2002	TN	79.0	79		M	10/29/2002	Patient received a flu and pneumonia vaccine on 10/24/02. On 10/29/02, he informed me his arm had swollen up and turned red over the previous few days. 10/29 Today he said it had subsided mostly but still a little swollen.									Y	10/24/2002	10/24/2002	0	None	OTH	OTH	Norvasc; Plaqnevil; Naproxen; Medezine; Lorazepam		Sjogren's Syndrome			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U0905FA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0210M~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192575	11/05/2002	PA	42.0	42		F	10/29/2002	Hives on arms. chest extremely pruritis.									Y	10/24/2002	10/25/2002	1	Uricaria	PVT	PUB		NONE				1						1	Rash pruritic; Urticaria	FLU3~SANOFI PASTEUR~U0971AA  exp 06~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192576	11/05/2002	NY	51.0	52		F	10/29/2002	Localized redness and swelling just days after vaccine in left deltoid. Since Monday, pain is gone and rash almost gone.									Y	10/22/2002	10/22/2002	0	NONE	PVT	PVT		NONE				1						1	Injection site erythema; Injection site oedema; Pain	FLU3~EVANS VACCINES~E30122FA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0192577	11/05/2002	TX	34.0	34		M	10/28/2002	Apprx. 24 hours following Influenza vaccination, pt experienced syncope and possible seizure activity (stiffness arms, thrashing, bit tongue and lip)				Y					Y	10/10/2002	10/11/2002	1	EKG, MRI brain, EEG-normal, CBC, CMP, Thyroid, Arthritis Panel all normal	OTH	OTH	Claritin D as needed for allergies	NONE	Hypercholesterolemia; Allergic Rhinitus			1						1	Convulsion; Musculoskeletal stiffness; Syncope	FLU3~SANOFI PASTEUR~U0911AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192578	11/05/2002	MS	36.0	36		F	10/28/2002	Approximately 24 hours after injection, 50 + mm raised area, red and hot to touch, pain, down arm and up shoulder, neck stiff, hip and knee joints achy x 72 hours. Temp 102 x 48 hrs. Fatigue, H/A. Took Benadryl x 24 hrs and Ibuprofen q 4 hours.									U	10/25/2002	10/26/2002	1	NONE	PVT	PVT	Celexa, Xanax prn	NONE	NONE			1						1	Arthralgia; Headache; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Musculoskeletal stiffness; Pyrexia	FLU3~EVANS VACCINES~E30132FA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0192579	11/05/2002	MS	75.0	75		F	10/29/2002	Within an hour, I had a severe attack of tachycardia, lasting approx 5 hrs,, incapacitating me to the extent I was too weak to move and when I did, would all but black out. I have had previous mild attacks but never with such severity and length. I have had the flu year annually for years. Consulted doctor following day and was advised to never had flu shot again.									Y	10/22/2002	10/22/2002	0		UNK	UNK						1						1	Asthenia; Loss of consciousness; Tachycardia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192580	11/05/2002	MI	47.0	47		F	10/21/2002	10/17/02, had pneumovax, tender that day. 10/18/02 swollen, red, inflamed 2x2 inches. Saw family MD-apply ice, cortizone cream, Advil, Benadryl-fever, chills, nausea, vomiting. 10/19/02 fever and chills 3 x 4 inches. 10/20/02 4 x 6 inches. 0/21/02 6 x 6 1/2 inches, extreme achiness shoulder to wrist.				Y					Y	10/17/2002	10/18/2002	1		PUB	PVT	Cozaar, synthroid, Premarin, Prevacid	NONE	Penicillin, asthma, hypertension	~Varicella (Varivax)~1~18.00~In Sibling		1						1	Chills; Injection site inflammation; Injection site oedema; Injection site pain; Nausea; Pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U0881AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0995L~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192581	11/05/2002	MT	65.0	65		F	10/18/2002	Pt c/o redness, swelling, lump at injection site 7 ours after injection.									Y	10/09/2002	10/09/2002	0	NONE	PVT	PVT	Fosamax, Prednisone, folic Acid, MTX	RA	RA, Osteoporosis			1						1	Injection site erythema; Injection site mass; Injection site oedema	FLU3~SANOFI PASTEUR~U0880AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192582	11/05/2002	IL	16.0	16		M	10/21/2002	Dizziness, blurred vision, headache, lethargy.				Y					U	10/21/2002	10/21/2002	0	NONE	PVT	UNK	Minocyclene	NONE	NONE			1						1	Dizziness; Headache; Lethargy; Vision blurred	FLU3~SANOFI PASTEUR~U0926FA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192583	11/05/2002	CT	73.0	73		F	11/04/2002	Had red, swollen arm after pneumonia shot. Treated at clinic.									Y	10/30/2002	11/02/2002	3		PUB	UNK						1						1	Unevaluable event	FLU3~EVANS VACCINES~531222GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0445M~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192584	11/05/2002	FL	67.0	67		M	11/04/2002	Malaise, fatigue, pain in left shoulder, temp elevation, muscle aches, sweats, Advil.									Y	11/01/2002	11/01/2002	0		PUB	PUB	NONE	NONE	NONE			1						1	Body temperature increased; Fatigue; Hyperhidrosis; Malaise; Myalgia; Pain	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0192646	11/05/2002	VA	73.0	73		F	10/31/2002	RA red, swollen, feverish. Localized Rt upper arm deltoid-cellulitis/local allergic rxn treated with 6 days of Zyrtec, warm soaks and mobic-resolved.									Y	10/20/2002	10/20/2002	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Cellulitis; Injection site erythema; Injection site oedema; Injection site reaction; Pyrexia	FLU3~EVANS VACCINES~53502KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1051L~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192784	11/05/2002	OH	53.0	53		F	11/05/2002	Itching,Wheezing, blotchy rash on face and neck,Swelling in throat  Started one hour after injection.  Took 25 mg Benadryl PO  when no relief repeated the Benadryl. 1:00 went to ED where she had Decadron, Breathing treatment with Albuterol and Atrovent. Prednisone 60 mg Po X4 days.				Y					Y	11/01/2002	11/01/2002	0	Information not available	PVT	PVT	unknown	None Known	None Known			1						1	Pharyngeal oedema; Pruritus; Rash; Wheezing	FLU3~SANOFI PASTEUR~U0909AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192785	11/05/2002	OH	60.0	60		M	11/05/2002	Received injection 10/24/2002 without incident.  Became ill on 10/25/2002 with severe diarrhea - denied fever, body aches or other symptoms.  Because is diabetic and has hx of CHF, was admitted to the hospital for hydration and monitoring of glucose and electrolytes.  D/C on 10/27/2002, but remains on bland diet as diarrhea returns otherwise.  Stool cultures completed did not isolate other bacteria or causative agents.  Pt saw PMD 10/30/2002 who, according to the patient, advised him to avoid flu shots in the future. Nurse follow up on 06/28/04 states: ADD: Nausea, Dehydration, Gastroenteritis.					Y	2			Y	10/24/2002	10/25/2002	1	Stool cultures negative for other bacteria or causative agents.	PUB	PUB	Meds unknown - on insulin	Denied allergy to eggs, drug neomycin and previous reaction to flu shots.  Denied fever or feeling ill.  Denied history of Guillian Barre Syndrome.	Diabetes, CHF We do not ask about allergies other than to eggs or the drug neomycin.  CHF, ASHD, Hypertension.			1						1	Dehydration; Diarrhoea; Gastroenteritis; Nausea	FLU3~SANOFI PASTEUR~U0933AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0192786	11/05/2002	OH	59.0	59		F	11/05/2002	Injection given Left Deltoid without incident or complaint.  Pt. left health department and traveled to Walmart where she received a flu shot in her Right Deltoid (this vaccine information is not available).  Approximately 30 to 60 minutes later, the pt's left arm began to hurt and became red at the injection site.  The symptoms progressed to swelling, then the area became hard and warm to touch.  Patient states she had difficulty sleeping that night because of the pain.  Pt. also states the area had a welt like appearance at the injection site; denied respiratory difficulties. States that after two sleepless night, due to the arm discomfort, symptoms diminished.  States by the third day, she has full functioning and mobility of the arm, denies any residual numbness or pain.  This was the patient's second shot, previous one was seven years prior, so it is not necessary for the injection to be repeated in the future.  Patient did not see her physician for these complications.									Y	10/17/2002	10/17/2002	0	N/A	PUB	PVT	Unknown, had just completed antibiotic for URI, received flu shot sometime later that afternoon, but symptoms had started while was waiting in line.	Denies illness or fever	Denies allergy to medications contraindicated by pnemovax vaccine and denied problems with previous pneumonia shot given more than seven years previously.			1						1	Injection site erythema; Injection site oedema; Injection site pain; Insomnia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~F0376M~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192787	11/05/2002	KS	77.0	77		M	11/05/2002	Red, swollen left upper arm, especially on its medial surface just above the elbow.  Tender to pressure.									U	10/30/2002	10/31/2002	1		PVT	PVT	Accupril, Proscar, Protonix, Albuterol inhaler, Serevent, Combivent	None	COPD, BPH, HTN, GERD, OA, PUD			1						1	Erythema; Oedema; Tenderness	FLU3~SANOFI PASTEUR~U0882AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0111M~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192789	11/05/2002	VA	0.0	71		F	11/05/2002	Localized reaction at injection site on left arm extending 3 to 4 inches from site.  The reaction began that night and continued into the next day.  It was treated with benadryl and the symptoms resolved.									Y	10/31/2002	10/31/2002	0		UNK	PVT						1						1	Injection site reaction	FLU3~EVANS VACCINES~E33502HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0445M~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192663	11/06/2002	MA	69.0	69		M	10/29/2002	Weak feeling. Referral to MD. Refused testing at ER visit 10/7/02. The follow up received on 11/18/03 states cont with burning sensation bil legs. pt also has decreased strength inboth arms and cont's with numbness and tingling when he walks.			Y						N	10/04/2002	10/05/2002	1		PVT	PVT			High cholesterol, hypertension, CAD, NIDDM type @ hypothyroid			1						1	Asthenia; Guillain-Barre syndrome; Hypoaesthesia; Paraesthesia	FLU3~SANOFI PASTEUR~U0879AA~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0192665	11/06/2002	CA	63.0	63		F	10/30/2002	Headaches, vomiting, ?, weakness, falling. This 63 yr old female is here for (dem) dizzy, head pressure walked 5 k -endorphin flow yesterday felt good (had trouble walking to mailbox months ago). Yesterday-room tilting with walking. Pressure front to back head. Lists to left falls into walls. No spinning.				Y	Y	2			Y	10/21/2002	10/27/2002	6	MRI Brain - normal	PVT	PVT	Tagamet, Atenolol, Bellergal, Betamethasone dipropionate, Claritin, Ecotrin, Flonase, Kenalog, Motrin, Nitroglycerin, pravachol, Sulfacet R, Westcort	NONE	Floxin, antihistamines, decongestants, prednisone.			1						1	Asthenia; Difficulty in walking; Dizziness; Headache; Vomiting	FLU3~SANOFI PASTEUR~U0883AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0192667	11/06/2002	LA	43.0	43		M	10/31/2002	Swelling and redness at site of injection. After reviewing the chart, it was noted that the pneumo shot was in the arm that reacted. The influenza shot had been in the other arm. It was the right arm that reacted.					Y	1			Y	10/22/2002	10/23/2002	1	CBC, Med. profile - all WNL	PVT	PVT	Enbrel, Arava, Dyszode	Reiter's Syndrome	NONE			1						1	Injection site erythema; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PNC~PFIZER\WYETH~490365~UNK~~~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0192668	11/06/2002	IN	12.0	12		M	10/31/2002	Patient developed idiopathic thrombocytopenia purpura with 1st symptoms noted 10/28/02. Platelet count 9,000 10/29/02. Symptoms: bruising and petechiae. Treated 10/29/02 with Winnho IV. Per 60 day follow up: pt has recovered. His recovery was rapid but treatment was costly. An annual follow-up report received 11/24/2003 adds: (Pt recovered). I never received a follow-up from VAERS with an opinion as to whether this reaction was from the flu vaccine.			Y	Y					Y	10/10/2002	10/28/2002	18	Hbg 15.3, WBC 4,800, platelet count 9,000, peripheral smear consistant with ITP per hematologist.	PVT	PVT	Concerta	NONE	ADHD			1						1	Contusion; Laboratory test abnormal; Petechiae; Thrombocytopenic purpura	FLU3~PFIZER\WYETH~4020020~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening	Influenza
0192672	11/06/2002	CA				M	11/04/2002	Violent itching, swelling of hand, buttock and legs.				Y					Y	10/30/2002	10/31/2002	1		UNK	UNK	PPV					1						1	Oedema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0192673	11/06/2002	IL	65.0	65		M	11/04/2002	My hands started to itch, became hot all of a sudden stomach started to hurt. These things happened in about an hour.									Y	10/24/2002	10/25/2002	1	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Abdominal pain upper; Body temperature increased; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192674	11/06/2002	NJ	70.0	70		F	11/05/2002	Terrible pain, fever, swelling, arm was really hard and red very very painful.				Y					U	11/01/2002	11/01/2002	0		UNK	UNK						1						1	Injection site erythema; Injection site induration; Oedema; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0192675	11/06/2002	MO	61.0	61		F	11/05/2002	Onset of chest pain armed 8pm eve of 11/2, around 1am 11/3 developed shortness of breath. Went to ER-cardio work up, observed for 12 hrs. Dx with possible arthritis rxn related to flu vaccine, cardiac workup negative, placed on antiinflammatory meds.				Y					U	10/30/2002	11/02/2002	3	Cardiac workup, including lab, EKG, treadmill	OTH	PVT	Paxil, Premarin, Atenadol	NONE	HTN, menopause, depression			1						1	Arthritis; Chest pain; Dyspnoea	FLU3~EVANS VACCINES~E32182KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0192676	11/06/2002	AR	33.0	33		F	10/31/2002	One to two hours after receiving injection complained of generalized hives with sl difficulty breathing, took OTC Benadryl. No problems with breathing today 10/31/02 and only a few hives.									Y	10/30/2002	10/30/2002	0		OTH	PVT		NONE				1						1	Dyspnoea; Urticaria	FLU3~EVANS VACCINES~E37182KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0192677	11/06/2002	MI	32.0	32		F	11/05/2002	Fine red, raised rash, itching, muscle/joint pain, fatigue. Rash was not only at injection site but arms and knees.									Y	11/01/2002	11/01/2002	0	NONE	OTH	OTH	Synthroid 50 mcg QO	NONE	Allergies-pcn, sulfa, hypothyroid disease			1						1	Arthralgia; Fatigue; Injection site rash; Myalgia; Rash erythematous	FLU3~EVANS VACCINES~E35822KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0192678	11/06/2002		67.0	68		F		A report was received from a consumer on 10/09/02 reporting a 67 year old female patient who experienced convulsions, loss of consciousness and headache requiring hospitalization after receiving Fluvirn vaccine in 10/05/02. At 5:00 am on 10/07/02,the patient experience a severe convulsion, with foaming at the mouth after receiving Fluvirin on 10/05/02. The patient became unconscious and was taken to hospital by ambulance. The patient was kept in the A & E department for tests before she could be discharged. All blood tests were reported as normal. The patient was given paracetamol. On the same day, the patient was discharge to treat the headache. which developed when the patient regained consciousness. On the same day, the patient was discharged from hospital. The patient has received flu vaccine previous without any problems and has had no history of convulsions in the past. The patient recovered on the same day. There was insufficient information to determine the reporter's causality's assessment. UPDATE: A follow-up received on 10/24/02 from the health professional which stated the batch number and confirmed that the patient was not taking other medication and had no past medical history. On 10/09/02, the patient experienced grand mal seizure requiring hospitalization. A  CT-scan of the brain was included. This report showed a mild degree of atrophy, which mainly affected the temporal lobes. No other focal intracranial abnormality was seen. there was no abnormal intracranial enhancement. A little basal ganglia calcification was noted, which is felt to probably be of no significance. The patient received previous flu vaccinations in 2000 and 2001. At the time of reporting, no cause has been found and the patient had recovered. The patient was discharged the same day, 10/09/02.there was insufficient information to determine the reporter's causality assessment.					Y	1				11/05/2002	11/09/2002	4	CT-scan	UNK	UNK	Concomitant drugs not used				PJP-2002-00478	1						1	Grand mal convulsion	FLU3~EVANS VACCINES~763454~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0192679	11/06/2002	PA	68.0	68		U		12 hours post injection, high temp 105 deg, cough, some weakness.									Y	11/01/2002	11/02/2002	1		PVT	OTH			HTN, DJD R knee, osteoporosis			1						1	Asthenia; Cough; Pyrexia	FLU3~SANOFI PASTEUR~U0957AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0820AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0192680	11/06/2002	NH	60.0	60		F	11/01/2002	Pt called RN on 11/1/02 to report she experienced a rash on her legs approx. 3 hrs after receiving flu shot on 10/31/02. Denies other s/s. She took Benadryl and rash subsided. She reports she was wearing new slacks. Client reported that rash developed one hour post wearing slacks and looked like measles. She states she felt as if her legs were on fire.									Y	10/31/2002	10/31/2002	0		PUB	PUB	Avapro		Allergic to sulfa drugs and iodine.		NH026	1						1	Rash	FLU3~SANOFI PASTEUR~U0943AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192681	11/06/2002	TX	57.0	57		F	11/04/2002	Swelling et redness 10cm to L arm. Area warm to touch, x 2 days of administration. Treated with Medrol dose pack.									Y	10/29/2002	10/31/2002	2	NONE	PVT	PVT	Allegra D12, Premarin, Zocor, Vitamins	NONE	Allergies: pcn et Xylocaine			1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~EVANS VACCINES~E30112GA~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~SANOFI PASTEUR~U0529AA~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0192682	11/06/2002	TX	62.0	62		F	11/04/2002	Pt experienced itching and redness at the injection MD gave Allegra pt stayed 30 min at the office and left with no adverse effets.									Y	10/25/2002	10/25/2002	0	NONE	PVT	PVT		Pt c/o fatigue				1						1	Injection site erythema; Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~4020016~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0192683	11/06/2002	WI	12.0	12		M	10/31/2002	12cm area of redness, induration, warmth on the left deltoid area at site of influenza vaccine two days ago. No stridor. No axillary lymphadenopathy.				Y					Y	10/26/2002	10/26/2002	0		PVT	PVT			ADHD, asthma, allergies			1						1	Injection site erythema; Injection site induration; Injection site warmth	FLU3~SANOFI PASTEUR~U0903AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192684	11/06/2002	ND	80.0	80		F	10/23/2002	Local area red and swelling. Tylenol-antihistamines prn.				Y					U	10/22/2002	10/22/2002	0		PVT	OTH	NONE	NONE	NONE		ND0216	1						1	Injection site erythema; Injection site oedema	FLU3~EVANS VACCINES~E35712KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1050L~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192685	11/06/2002	FL	4.3	4		M	10/31/2002	Left leg swelling, limping, increased warmth. Tx supportive like compress/elevation/NS.									Y	10/30/2002	10/31/2002	1		PVT	PVT	NONE	NONE	NONE			1						1	Feeling hot; Gait disturbance; Injection site oedema	DTAP~SMITHKLINE BEECHAM~528A9~5~~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U0904CA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W0196~4~~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0773M~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0192686	11/06/2002	CA	39.0	39		F	10/29/2002	Received flu vaccine in mass screening clinic. Walked back to office felt funny dizziness, felt throat discomfort, monitored. No SOB, stable vx. Benadryl 25mg po. stable. No rash, no SOB. Previous admits to feeling anxious prior to shot so took Xanox-because of anxiety about getting a vaccine. Known diabetic did not take blood sugar. Walked to ED in f/u for monitoring. Left after 15 mi didn't want to and not further problem Called 10/29/02 no further problems.				Y					Y	10/22/2002	10/22/2002	0	NONE	PVT	PVT	Xanax	NONE	Diabetes			1						1	Discomfort; Dizziness; Feeling abnormal	FLU3~SANOFI PASTEUR~U0919AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192687	11/06/2002	WI	76.0	76		U		Red, raised, erythematous areas (hives) to arms, torso, legs per pt family reported.									U	10/28/2002	10/29/2002	1	NONE	PVT	UNK						1						1	Erythema; Rash erythematous; Urticaria	FLU3~SANOFI PASTEUR~U0937AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0735M~3~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192688	11/06/2002	KS	58.0	58		F	10/29/2002	Red, swollen, warm to touch left arm.									Y	10/28/2002	10/29/2002	1	NONE	PVT	OTH		NONE	ASA, Compazine, Anti-Inflamm, Steroids, Percocet, Asthma, Diabetes, Osteoarthritis			1						1	Erythema; Feeling hot; Oedema	FLU3~SANOFI PASTEUR~U0882AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0709M~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192689	11/06/2002	IL	70.0	70		F	10/31/2002	Client states ~ 9pm on 10/29/02 L arm sore, swollen, had a knot and redness at site of injections. Wed am noted redness and swelling of entire arm from shoulder to elbow. Wed evening developed abdominal cramping and diarrhea. Thursday am she states redness/swelling of arm decreasing. Few abdominal cramps. Advise to see physician if symptoms worsen.									Y	10/29/2002	10/29/2002	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Abdominal pain; Diarrhoea; Injection site erythema; Injection site mass; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U0903AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1353L~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192690	11/06/2002	IL	68.0	68		F	10/31/2002	Evening of 10/29/02 client with fever, chills, body aches, neck ache. Also noted redness and some swelling below site of injections Wed am symptoms continued with increased swelling/redness from injection site to elbow. Thurs am noted redness/swelling spread. Red and swollen ~ 4 band circling arm below injection site and ~ 2 above elbow. Tricep area only area not involved. Advised to see physician. Client state latex allergy. 11/1/02 spoke with client who saw MD 10/31/02 started on Keflex and steroid on arm. Redness decreased intensity but swelling same.									Y	10/29/2002	10/29/2002	0	NONE	PUB	PUB	NONE	NONE	Latex allergy, pcn, sulfa, steorids, h/o diverticulitis			1						1	Chills; Injection site erythema; Injection site oedema; Neck pain; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U0903AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1353L~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192691	11/06/2002	CO	2.0	2	.0	M	11/01/2002	Red erythematous region, 3-4cm at site of injection. Local reaction.									Y	10/28/2002	10/29/2002	1	NONE	PVT	PVT		NONE	NONE			1						1	Injection site erythema; Injection site reaction	DTAP~SANOFI PASTEUR~C0889AA~1~~~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U0945AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192692	11/06/2002	NY	5.0	5		M	10/30/2002	About 6 hrs after vaccines were administered child developed generalized rash and swelling of lips.				Y					Y	10/28/2002	10/28/2002	0		PUB	PUB	NONE					1						1	Face oedema; Rash	FLU3~SANOFI PASTEUR~U0877AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1351L~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192694	11/06/2002	CA	88.0	88		F	10/28/2002	Felt tingling after injection. Began to swell and increase pain that same day. Unable to move arm L. Applied ice on/off for 15 min each time. Pain and swelling lasted 6-7 days.									Y	10/22/2002	10/22/2002	0	NONE	OTH	UNK			Pt blind (partial) ambulates with walker.			1						1	Hypokinesia; Injection site oedema; Injection site pain; Paraesthesia	FLU3~SANOFI PASTEUR~U0919AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192696	11/06/2002	FL	74.0	74		F	10/25/2002	Pt got flu and pneumovax shot at 10:30am by 4:00 felt L arm heavy by 6pm felt hot L arm soreness, neck and shoulder were stiff, hurt in bed, got up at 1am and temp was 102 degrees. Took ASAT po helped after one hour ease sx's and at 5am went back to bed.				Y					Y	10/24/2002	10/24/2002	0	NONE	PVT	PVT	Norvasc 10mg, Diazide 37, Toprol XL 100mg, ASAOD		NKA			1						1	Injection site pain; Joint stiffness; Musculoskeletal stiffness; Pyrexia; Sensation of heaviness	FLUX~UNKNOWN MANUFACTURER~E32072GA~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0358M~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192697	11/06/2002	MN	65.0	65		F	10/31/2002	Approx. 8 hrs following vaccines administered developed flu-like symptoms, followed by pain, swelling and rash to upper arm around injection site. Given steroid ointment and po meds plus pain meds.									U	10/29/2002	10/29/2002	0	NONE	PVT	PVT	Fiarinal, Imitrex, Evista, Medrol, Motrin		Occasional migraines, hypercholesterolemia, osteoarthritis, migraines			1						1	Influenza like illness; Injection site oedema; Injection site pain; Injection site rash	FLU3~SANOFI PASTEUR~U0982AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1050L~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192704	11/06/2002	WI	5.0	5		F	10/31/2002	Arms red, swollen Rt Lt, crying 3-4 hrs. Treated with Benadryl, better next day.									Y	10/29/2002	10/29/2002	0	NONE	PVT	PVT	Omnicef, Nexium, Singulair, Reylin, Zyrtec, Palmocort		Sinusitis, asthma, GERD			1						1	Injection site erythema; Injection site oedema; Screaming	DTAP~SANOFI PASTEUR~U0846CA~5~IM~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U0886AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W0013~4~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0624M~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0192705	11/06/2002	OR	78.0	78		F	10/30/2002	Pt's husband called our office at 4:30pm on 10/16 and reported her R arm was swollen and quite painful. It resolved in a few days with ice and ibuprofen.									Y	10/16/2002	10/16/2002	0		PVT	PVT		NONE	OM			1						1	Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U0872AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1352L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192706	11/06/2002	NY	39.0	39		F	10/31/2002	Vaccine given at 2:50pm, employee noted itching, hives by 6:30pm same evening, took Benadryl when arrived home, took Benadryl again next am, came into work at 9pm with some itching, hives, by 5pm covered with hives, sent home, took Benadryl, seen by own MD next am (10/30) given Rx for Atarax and Prednisone.				Y					Y	10/28/2002	10/28/2002	0	NONE	OTH	OTH	NONE	NONE	Latex allergy; asthma/allergies to dust, grass, etc.			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0904CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192707	11/06/2002	TX	51.0	50		M	10/28/2002	One day post receiving flu vaccine noticed ear ache/pressure bilateral that progressed to pain behind rt ear on 10/23/02. Started having numbness to rt side of face. Was dx with Bell's palsy.				Y					U	10/17/2002	10/18/2002	1	Had CBC and other lab done on 10/23/02	PVT	PVT	Lisinapril, Gemfibrozil, Gluconamin	NONE	Hx of hypertension, high triglycerides			1						1	Ear pain; Facial palsy; Hypoaesthesia	FLU3~SANOFI PASTEUR~U0949AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192708	11/06/2002	MO	29.0	29		F	10/31/2002	Client vaccinated at call bank at flu clinic at 8:50am. Approx. 25 mins later fellow employee came up to where nurses were given shots and told us above was having trouble breathing-went down to clients office-had head down on desk, c/o dizziness, anxious, pale. Epi given 911 called-ambulance responded in 6 mins-taken to hosp for monitoring. Was discharged at 10:40am.				Y					Y	10/31/2002	10/31/2002	0		OTH	OTH	Allergy shots		PCN, Ultram			1						1	Anxiety; Dizziness; Dyspnoea; Pallor	FLU3~PFIZER\WYETH~4020025~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0192709	11/06/2002	FL	81.0	81		M	10/29/2002	The pt developed a large area of erythema/swelling/and tenderness around the injection site which spread into the forearm. There was no fever, and treatment with antibiotics for presumed cellulitis had no effect on it.									Y	10/22/2002	10/25/2002	3	NONE	PVT	UNK		NONE				1						1	Cellulitis; Injection site erythema; Injection site oedema; Injection site pain; Injection site reaction	FLU3~SANOFI PASTEUR~U0934EA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192710	11/06/2002	WI	79.0	79		F	10/30/2002	Bell's palsy onset 10/26/02.				Y					N	10/23/2002	10/26/2002	3	Lyme titer pending	PVT	PVT	B12, nitroglycerin-prn, Gemfibrozil, Lopressor, Aspirin	NONE	Hyperlipidemia, hypertension, perniclous anemia, coronary artery disease			1						1	Facial palsy	FLU3~SANOFI PASTEUR~U0882AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192711	11/06/2002	NY	46.0	46		F	10/31/2002	L arm-vaccine given 10/30/02 has swelling, warmth and redness from fingers to vaccine site.				Y					U	10/30/2002	10/30/2002	0	NONE	PVT	OTH	Nevrontin, Singulair, Vioxx, Prilosec, Primidone, Tylanclaoline, Intal, Percoset, Zyban, Keflex		COPC/convulsions/eczema, allergies to sulfa, indomethmia			1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U0913AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0111M~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192712	11/06/2002	NV	72.0	72		M		Per wife, the pt had a seizure at home. Unable to give a time as to how long pt had what was a seizure at home. She called 911 and husband transported to ER. Arrived at ER-CT done-discharged at 4:30pm husband has had a seizure last year 9 days after flu vaccine given.				Y					Y	10/15/2002	10/26/2002	11		PUB	UNK	O2	NONE				1						1	Convulsion	FLU3~PFIZER\WYETH~4020025~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0192713	11/06/2002	MO	19.0	19		F	10/25/2002	By report from mother: day after vaccines, pt developed a red area around left arm vaccine site and also a blistery ring of lesions around injection site. Went to different medical facility who gave her Keflex and Valtrex for infection and shingles.									Y	10/10/2002	10/11/2002	1		UNK	PUB						1						1	Herpes zoster; Infection; Injection site erythema; Injection site vesicles	FLU3~SANOFI PASTEUR~U0924DA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0172M~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192714	11/06/2002	OR	61.0	61		F	10/31/2002	L arm started to swell and was painful 10/29 in am 100.5 by 12 noon 10/29/02 + H/A + sweats. Arm cont. to swell until 10/29/02 in pm evening. L arm still swollen painful and red.									Y	10/28/2002	10/29/2002	1		PUB	UNK	Premarin, Paxil, vitamins	NONE	NONE			1						1	Headache; Hyperhidrosis; Injection site erythema; Injection site oedema; Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~U0920AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192716	11/06/2002	TX	4.0	4		M	10/29/2002	3cm induration at site of MMR and erythema.									Y	10/29/2002	10/29/2002	0		PVT	PUB	Nasalcrom, Singulari, Flovent	NONE	Asthma, Premie-extreme, G tube, GERD			1						1	Injection site erythema; Injection site induration	DTAP~SANOFI PASTEUR~U0582DA~5~~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U0877AA~5~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~U14284~4~~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1207L~3~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0192717	11/06/2002	NV	65.0	65		F	10/28/2002	Chills, uncontrollable shaking, severe muscle aches, lost use of right arm-48 hours.									Y	10/21/2002	10/21/2002	0	NONE	PUB	UNK	Oxygen	NONE	NONE			1						1	Chills; Hypokinesia; Myalgia; Tremor	FLUX~UNKNOWN MANUFACTURER~U0926E17~4~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~1264L~1~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0192718	11/06/2002	ME	25.0	25		F	10/28/2002	Staff person received flu vaccine and approx. 2 1/2 hrs later c/o fatigue pain in neck in upper chest and felt SOB appeared anxious. P130-140, R 20 then fewlminutes later c/o numbness and tingling in fingertips skin normal color and temp. Observation only in ER. Tx with Benadryl po IV and 25 mg po Q 6 x 48 hours at home.				Y					Y	10/22/2002	10/22/2002	0		OTH	PUB	Orthotrycycline	NONE	NONE			1						1	Chest pain; Dyspnoea; Fatigue; Hypoaesthesia; Neck pain; Paraesthesia	FLU3~SANOFI PASTEUR~U0904CA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192720	11/06/2002	KS	33.0	33		F	10/24/2002	8:45am flu vaccination given, reports she had dull headache by 1 hr after injection, c/o weakness, nausea, flush fleeing. By 2 hrs report she had vomiting, increased headache. 10:50 pt describing symptoms, no SOB, hives, swelling of throat. Advised to take po Benadryl. 2:45pm reports feeling flushed. No headache. Did not take Benadryl.									N	10/22/2002	10/22/2002	0		OTH	PVT		C/O headahe. Children have colds at home.				1						1	Asthenia; Headache; Hot flush; Laryngeal oedema; Nausea; Urticaria; Vomiting	FLU3~SANOFI PASTEUR~U087AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192721	11/06/2002	TX	18.0	18		F	10/31/2002	Had itching, redness, and pain at injection site within ~ 15 min. progressed to dry throat that felt swollen within 2 hrs.				Y					Y	10/30/2002	10/30/2002	0	NONE	UNK	PVT		NONE	NONE			1						1	Dry throat; Injection site erythema; Injection site hypersensitivity; Injection site pain; Laryngeal oedema; Pruritus	FLU3~SANOFI PASTEUR~U0881AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192722	11/06/2002	FL	68.0	68		F	10/30/2002	From pneumonia shot: within 1 hr of injection arm became very sore, then achy, then painful to use. At site of injection arm slightly swollen, very painful to touch. Symptoms lasted approx 6 days.									Y	10/17/2002	10/17/2002	0		PUB	PUB		NONE	NONE			1						1	Injection site oedema; Pain	FLUX~UNKNOWN MANUFACTURER~0735M~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0192723	11/06/2002	NC	52.0	52		F	10/30/2002	She developed local reaction at the injection site. Right arm with pain, swelling and erythema (Pnuemovax site)				Y					U	10/29/2002	10/29/2002	0		PVT	PVT		No acute illness - has ovarian cancer & hypothyroidism	Penicillin, Kiflex, Tetracycline, Baxin, Emycin, Dextram, Nethogen, Telactia			1						1	Erythema; Injection site reaction; Pain; Swelling; Hypokinesia; Injection site erythema; Injection site oedema; Pyrexia	FLU3~SANOFI PASTEUR~U0933AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0995L~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~3	USA	Emergency room visit	Influenza
0192724	11/06/2002	MI	65.0	65		F	10/25/2002	Leg red, warm, hard lump to left deltoid, rash and red to neck, throat. Face red.				Y					Y	10/23/2002	10/24/2002	1	NONE	PVT	UNK		NONE	NONE			1						1	Erythema; Rash	FLU3~SANOFI PASTEUR~U0949AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0923L~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192725	11/06/2002	IL	47.0	46		F	10/24/2002	Local redness, itching, tenderness to right arm. Red blotches on arms and chest. Benadryl 25mg tablet given.									Y	10/24/2002	10/24/2002	0		PUB	UNK	NONE	NONE				1						1	Injection site erythema; Rash macular; Tenderness	FLU3~SANOFI PASTEUR~40888AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192726	11/06/2002	CA	59.0	59		F	10/29/2002	Complain of arm hurting and sore red hot area approximately 4cm. Prescription for medrol dose.   Use benedryl oral care.										10/28/2002	10/28/2002	0		PVT	OTH		NONE	Codeine & Sulta			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U0875AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192727	11/06/2002	MN	26.0	26		F	10/28/2002	Hives within 2 hours after injection at site. Influenza - pain into axilla Left arm & back x 24 hours. Prescribed w/ tylenol & ibuprofen, gave in 48hrs.									Y	10/24/2002	10/24/2002	0		OTH	OTH	Celexa, Alegral, albuterol, Loestrin, Flovent	NONE	Reglen			1						1	Pain; Urticaria	FLU3~PFIZER\WYETH~H020020~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0192743	11/06/2002	OR	52.0	52		F		had pneumonia vacc 10am Sat on 10/26/02 some slight swelling immediately-continued to swell more and inflamed.									U	10/26/2002	10/26/2002	0		UNK	UNK		NONE	NONE			1						1	Injection site inflammation; Injection site oedema	FLU3~EVANS VACCINES~E30112GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0192790	11/06/2002	PA	55.0	55		F	11/06/2002	Sudden onset of vomiting, ached all over.Took Tylenol. Fine on Saturday.									Y	10/23/2002	10/25/2002	2	Temp of 100 orally	PUB	PVT	Unknown	None	Unknown			1						1	Pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U0969AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192791	11/06/2002	WA	51.0	51		M	11/06/2002	HI FEVER  BODY CRAMPS  INDIGESTION SEVERE HEADACHE HEARTBURN STARTED EARLY EVENING AND RECOVERED BY 6 AM.									Y	11/05/2002	11/05/2002	0		UNK	UNK						1						1	Dyspepsia; Headache; Muscle spasms; Pyrexia	FLU3~SANOFI PASTEUR~UO932AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192792	11/06/2002	MO	37.0	37		F	11/06/2002	Ringing in ears upon waking up the morning after adminstration, tinnitus.  Patient was treated with Benadryl and Antivert									Y	11/04/2002	11/05/2002	1		PUB	PVT		None	None			1						1	Tinnitus	FLU3~SANOFI PASTEUR~U0906BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192843	11/06/2002	WI	18.0	18		F	11/06/2002	Tired, dizzy, headache, slight fever									Y	11/06/2002	11/06/2002	0		UNK	PVT	Allegra, Allegra-D, Singulair, Centrum Peformance	none	Food Allergies (tree nuts) and Asthma			1						1	Dizziness; Fatigue; Headache; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192844	11/06/2002	IL	1.2	1	.2	M	11/06/2002	Influenza vaccine given 10/14/2002. Pt not showing any significant symptoms at that time. Pt returned to office 10/15/2002 due to significant crying episodes since previous day. Mom reported that pt had some mildly rhinorrhea and congestion the previous week and pt's brother has a URI with OM recently. On exam pt was noted to have an erupting tooth and some mild nasal crusting but no other findings. Pt returned to the office 10/17/2002 with persistent crying and was crying non stop yesterday according to the mother. pt had normal liquid intake but had limited solid intake. Nothing other than the erupting tooth and mild nasal congestion were found on exam. On 10/19/2002 the pt was taken to a local hospital after calling this physician due to leg pain and limp, no tenderness with passive movement noted. At hospital pt had no x-rays and was diagnosed with Transient Synopis. With in 1-2 days pt had normal ambulation and no week presumed to be due to teething. Pt returned to the office on 10/28/2002 after developing mild diarrhea, significant anorexia and several episodes of vomiting over the prior weekend. Pt had no solid intake the entire weekend but drank some Pedialyte and some milk. Pt's irritability persisted. On 10/28/2002 pt had a rectal exam which showed a questionalbly positive hemoccult on 1 small area of the card. On 10/30/2002 pt returned to the office again with irritability. This time pt was noted in the office to have episodic irritability. Pt was monitored in the office for several hours and eventually sent to hospital with concern for intussusception. Pt was found to have slightly decreased bowel gas on the right with small air fluids levels within the right lower quadrant. Pt had a barium enema which showed a small ilececal intussusception which was hydrostatically reduced. Pt was monitored overnight and sent home the next afternoon. Within 1-2 days pt was acting perfectly normal. The discharge summary states abdominal pain.				Y	Y	1			Y	10/14/2002	10/19/2002	5	10/30/02--normal CBC 10/30/02  abnormal abd. x-ray 10/30/02  barium enema--intussusception	PVT	PVT		Questionable mild URI symptoms. Two upper primary 1st molars erupting.	Nasolacrimal duct stenosis s/p surgical probing 2/2002.			1						1	Abdominal pain; Anorexia; Crying; Diarrhoea; Intussusception; Irritability; Nasal congestion; Pain; Rhinorrhoea; Tenderness; Tooth disorder; Vomiting	FLU3~SANOFI PASTEUR~UO918AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0192801	11/07/2002	MD	82.0	82		F	11/01/2002	Patient had flu shot on 10/23/02 in left arm pt came in on Saturday 10/25/02 with massive hematoma from shoulder to elbow.  I referred pt immediately to family doctor. Doctor said artery was nicked. I contacted the vaccine provider and also gave patient's doctor the info as well as the patient. I contacted the visiting nurse association and the vaccine's manufacturer.  Massive hematoma did not appear until Thursday evening as per patient.				Y						10/23/2002	10/23/2002	0		OTH	UNK						1						1	Injection site haemorrhage	FLU3~PFIZER\WYETH~4020017~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0192802	11/07/2002	NY	20.0	20		F	10/30/2002	Patient received flu shot at 1:30 PM on 10/23/02. About 4PM of that day, reported developing hives. Called to report. Told to take Benadryl for relief. Seen by doctor 10/28/02; still complains of occasional itching. No rash SOB, etc at visit. To continue Benadryl.									N	10/23/2002	10/23/2002	0	None	OTH	OTH	Birth Control Pills	Mild URI Symptoms	None			1						1	Dyspnoea; Pruritus; Rash; Urticaria	FLU3~PFIZER\WYETH~4020027~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0192803	11/07/2002	KY	44.0	44		F	11/01/2002	Patient reports 10/25/02 18:00 to approximately 23:30, itching all over her body with no rash or fever. 10/26/02 face bright red with rash and itching of face. Face also hot to touch. The rash and itching of face only occurs in the evenings according to the patient. No rash or itching of any other part of her body. Patient has been referred by her doctor to see dermatologist today. 11/1/02.				Y					U	10/25/2002	10/25/2002	0	None	PUB	PUB	Altace; Singular; Celebrex; Trileptal; Fibercon; Topomax; Vitamin E; Ecotrin; Multivitamin; Loestrin; Glucophage; Clonidine; Flovent inhaler		Diabetes, HBP, IBS, Asthma, Sleep apnea, Neuropathy, Fibromyalgia, Bipolar			1						1	Erythema; Pruritus; Rash	FLU3~SANOFI PASTEUR~U0886AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192804	11/07/2002	VA	43.0	43		F	11/01/2002	09:45 Stiff neck; approximately 10:15 tightness in throat; 10:30 tightness in chest; 10:45 pressure/weight on chest making it a little difficult to breathe. 1st reported to nurse at 11:00; recheck at 1:00. Manufacturer notified 1:45; doctor notified 2:00. Ambulance 2:20 to ER.				Y					Y	10/31/2002	10/31/2002	0	EKG	OTH	UNK	ASA, Zocor, Novalog	Laryngitis	Type I Diabetes, MVP			1						1	Chest discomfort; Dyspnoea; Throat tightness	FLU3~EVANS VACCINES~E34662HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0192805	11/07/2002	AZ	53.0	53		F	10/31/2002	Patient complained of left arm rash after receiving the flu vaccine. Stated it felt hot at first. Patient seen by clinician and given Benadryl 25mg IM to left deltoid. Patient experienced no shortness of breath.									U	10/31/2002	10/31/2002	0		PUB	OTH	None	Hives to left deltoid	None			1						1	Dyspnoea; Feeling hot; Rash	FLU3~SANOFI PASTEUR~U0883AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192806	11/07/2002	FL	72.0	72		M	10/31/2002	Right arm swollen and painful.									U	10/30/2002	10/30/2002	0		PUB	PVT		None	Legally blind			1						1	Swelling	FLU3~SANOFI PASTEUR~U0925AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0735M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192807	11/07/2002	FL	47.0	47		F	10/28/2002	Pain into chest area, shoulder blade, neck area on left side down left arm.									Y	10/24/2002	10/24/2002	0		PUB	PVT		Couple day prior cold symptoms	NONE			1						1	Chest pain; Neck pain; Pain	FLU3~SANOFI PASTEUR~U0925AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192808	11/07/2002	NE	73.0	73		M	10/20/2002	Pain-local redness-fever.				Y					U	10/28/2002	10/28/2002	0	NONE	PVT	UNK	Synthroid	NONE	ASA-GI upset			1						1	Injection site erythema; Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~U0888AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0172M~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192809	11/07/2002	VA	45.0			F	11/01/2002	Redness warmth back of arm 11x8cm.									Y		11/01/2002		NONE	PVT	PVT		NONE	NKA			1						1	Injection site erythema; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~E33162GA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192810	11/07/2002	IL	39.0	39		M	10/24/2002	Very sore arm-joint sore-limits comfortable arm movements. Did not even feel shot at next day sore arm. Progressing worse until 10/20/02 then subsided slightly. Now constant ache in upper arm and joint.									N	10/01/2002	10/02/2002	1		OTH	PUB	NONE	NONE	NONE			1						1	Arthralgia; Hypokinesia; Injection site pain; Pain	FLU3~SANOFI PASTEUR~U0906BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192811	11/07/2002	IL	47.0	47		M	10/24/2002	Sore arm and shoulder joint area. Started the day after the shot was given. Pain and soreness still felt today.									N	10/01/2002	10/02/2002	1		OTH	OTH	NONE	NONE	Allergic to pcn			1						1	Arthralgia; Injection site pain	FLU3~SANOFI PASTEUR~U0906BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192812	11/07/2002	CA				U		Impossible to breathe deeply. Dizziness and pain in the back.									U	11/04/2002	11/04/2002	0		UNK	UNK						1						1	Back pain; Dizziness; Dyspnoea; Hypoventilation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192813	11/07/2002	PA	81.0	81		F	11/01/2002	Redness, tenderness, edema, urticaria at site.									Y	10/31/2002	11/01/2002	1	NONE	PVT	UNK	Sular, Detral, Eviate, Antivent, Celexa, Celebrex, Ambien, Cipro					1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0735M~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192814	11/07/2002	WV	63.0	63		F	10/30/2002	C/O itching on the site of injection about 10 min after rec. the vaccine. Red, warm, swelling area on the site of injection about 25-60 cm in size.				Y					Y	10/28/2002	10/28/2002	0	NONE	PUB	PUB		NONE			WV0212	1						1	Injection site erythema; Injection site hypersensitivity; Injection site oedema; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U0922AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192815	11/07/2002	WI	66.0	66		F	11/06/2002	On 10/23/02, the pt received the influenza vaccine as described. On 10/26/02 at around 4-5pm, the pt began feeling weak and described being wiped out. She began having diarrhea, nausea and weakness and stomach cramps. She was bed ridden for five days. She also described having blood in the stools and cramping. She had little or no appetite and only consumed water and fluids. She also described having a foul odor of rotten eggs for 2 days that was associated with her bowel movements. She recently is back on her feet and beginning to feel better but still looks pale. She also has lost 10 pounds during this recent illness. Onset fatigue, nausea, malaise, diarrhea x 5 days. Had some blood in stool. Taste and smell of rotten eggs x 2 days. Bed rest- fluids only- did not see her MD									N	10/23/2002	10/26/2002	3		OTH	OTH	Glucotrol XL, Lotensin, Metformin, Avandiay		Type II Diabetes			1						1	Abdominal pain; Anorexia; Asthenia; Diarrhoea; Dysgeusia; Fatigue; Gastrointestinal disorder; Haematochezia; Malaise; Nausea; Pallor; Parosmia; Weight decreased	FLU3~PFIZER\WYETH~40020012~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0192816	11/07/2002	TX	19.0	19		F	11/06/2002	(11-2) Hives the next morning after shot; increased (more and itching) on 11/30-took Benadryl tablets to relieve-3rd day(11/4) hives decreased.									Y	11/01/2002	11/02/2002	1		OTH	UNK	Paxil	NONE	NONE			1						1	Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192845	11/07/2002	SC	46.0	46		F	11/07/2002	Given the shot at approx. 3:45 p.m. on Monday, October 28.  By 7:00 p.m., I noticed that my arm was very sore and itching around the site where I'd had the shot.  Upon examination, I noticed that my whole upper arm was red to the elbow and my entire arm was swollen to my wrist.  I called my sister-in-law who is a neurosurgical nurse, who suggested that I take Tylenol and put an ice pack on the site.  I sent my husband to the store to buy Benadryl, which I took around 8:30 and then again at 12:30 a.m.  The next morning, my arm was swollen, sore, and red again, so I took the Benadryl and Tylenol again, taking every 4 hours the next day.  I called the Health Dept and talked to someone in immunizations who basically did not seem concerned at the reaction I'd had.  She thought it sounded like a latex allergy and said since it seemed better, that it would probably be ok.  I reminded her that I was only better because I was taking Tylenol and Benadryl every 4 hours.  By Wednesday, I noticed that the site was reduced to a quarter sized red spot of inflammation around the injection site.  This remained through Thursday.									Y	10/28/2002	10/28/2002	0	none	PUB	PVT	None	None	Allergy to Sulfa suspected, but not proven (both children are allergic to Sulfa).			1						1	Erythema; Oedema; Pain; Pruritus	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192923	11/07/2002	SC	62.0	62		F	11/07/2002	Patient received vaccine on 11/5/02.  Returned with erythema and enduration at vaccine site 15*10 cm.  Very tender.  No fever.  Patient does complain of Headache.									U	11/05/2002	11/05/2002	0	None	PVT	PVT	Lipitor, Ziac, Premarin, Altace, Prilosec, Librium, Aspiring, Vit E, Oscal, MVI	Hypertension, IBS, Hyperlipidemia	Allergic to adhesive tape			1						1	Headache; Injection site erythema; Injection site induration; Tenderness	FLU3~EVANS VACCINES~E30112GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0445m~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192927	11/07/2002	OR	26.0	26		F	11/07/2002	Low grade fever, body aches, sorethroat, headache, and nausea.				Y					Y	10/28/2002	10/28/2002	0	None	PVT	PVT	Ortho tri cyclen, Topamax	None	None			1						1	Headache; Nausea; Pain; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~UO921DA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192723	11/08/2002	NC		52		F		Edema, erythema, low grade temp, unable to flex at elbow 2 hours, severe edema.				Y					Y	10/29/2002				PVT	UNK			Post chemotherapy for CA			1						3	Erythema; Injection site reaction; Pain; Swelling; Hypokinesia; Injection site erythema; Injection site oedema; Pyrexia	FLU3~SANOFI PASTEUR~U0933AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0995L~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~3	USA	Emergency room visit	Influenza
0192848	11/08/2002		88.0			F		It was received from a regulatory authority on 10/29/00, concerning an 88 year old pt who experienced cardiac failure and ventricular hypertrophy which led to death 16 days after receiving the Fluvirin vaccine on 10/1/02. The pt had a medical history of dementia, lower respiratory tract infection in June 2002, influenza and anaemia. The pt had been receiving the flu vaccination since 1993. On 10/17/02, 16 days after vaccination, the vaccinee developed an acute cardiac failure following left ventricular hypertrophy and subsequently died. A post mortom examination was performed and cardiac failure was reported as the probable cause of death. The reporter has assessed the relationship of the vaccine to the events as having a direct or indirect association.	Y								N	10/01/2002	10/17/2002	16		UNK	UNK	NONE				PJP200200544	1						1	Cardiac failure; Hypertrophy	FLU3~EVANS VACCINES~763353~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0192855	11/08/2002	TX	62.0	62		F	10/16/2002	Itching all over-difficulty breathing, shaking, tachycardia. Hospitalized for 7 days after influenza shot.				Y	Y	7			Y	10/09/2002	10/09/2002	0		PUB	OTH	Isosorbide Mononitrate; Levothroid, Lonixin, Provera; K-Dur	5 By-passes, CHF, MI	CHF, History of MI		TX02116	1						1	Dyspnoea; Pruritus; Tachycardia; Tremor	FLU3~SANOFI PASTEUR~U0925AA~7+~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0192856	11/08/2002	GA	58.0	58		M	11/07/2002	Respiratory asthma. Achiness which went away.			Y						U	10/07/2002	10/12/2002	5		UNK	UNK	Albuterol					1						1	Asthma; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0192859	11/08/2002		45.0	45		M	10/24/2002	Pt experienced achiness on date of shot. Today elbow is red (~10 inches in length from top of arm to elbow), swollen and hot/warm to touch. Pt has been taking Motrin since Monday. This is pt's 5th vaccination.				Y					Y	10/21/2002	10/24/2002	3		MIL	MIL	NONE	NONE	NONE			1						1	Injection site oedema; Injection site warmth; Pain	ANTH~EMERGENT BIOSOLUTIONS~FAV064~5~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~EVANS VACCINES~E34692HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0192861	11/08/2002	VA	38.0	38		M	11/01/2002	Large localized, swollen, reddened area at injection site, followed by a generalized rash on abd, trunk, back and arms. Started approximately 12 hrs post injection. Treated with Benadryl.									Y	10/22/2002	10/22/2002	0	NONE	PUB	UNK			Asthma, Ehlers Doulos Syndrome		VA02035	1						1	Ascites; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U0877AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192862	11/08/2002	MS	54.0	54		F		Fever, swelling at arm, nausea, slept for 32 hrs. Still sore after two weeks. Fatigue and headache also. Redness rt arm.									Y	10/14/2002	10/14/2002	0		PUB	PVT	NONE					1						1	Fatigue; Headache; Injection site erythema; Injection site oedema; Injection site pain; Nausea; Pyrexia; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0192863	11/08/2002	SD	61.0	61		F	10/30/2002	Cellulitis L arm. Rx Cephaloxin tid x 10 days. Warm, moist packs.				Y					Y	10/23/2002	10/23/2002	0		PVT	PVT	Norvase, Claritin, Zocor, Estrogen patch	NONE	HTN, hyeprlipidemia			1						1	Cellulitis	FLU3~PFIZER\WYETH~4020035~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0675M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192864	11/08/2002	MA	34.0	34		F	11/01/2002	10/30/02, Pt received pneumococcal shot 0.5 ml IM left arm and Flu vaccine o.5 ml IM RA 11/1/02 called  health clinic w c/o left arm red, blotchy unable to lift, Hives on face, itchy welts on face and chin, She called her allergist took Clariton itching resolved welts resolving-advised to take Tylenol. Pt left clinic  some redness and cellulitis, Will call back Monday.										10/30/2002	11/01/2002	2		PVT	PUB		Annual Physical	NSAIDS, ASA, Motrin, Codeine, Oxycodone, Demerol,Sulfa, Cefoxidine			1						1	Cellulitis; Injection site erythema; Injection site reaction; Joint range of motion decreased; Pruritus; Rash macular; Urticaria	FLU3~EVANS VACCINES~UO953AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1116L~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192870	11/08/2002	OH	82.0	82		F	12/18/2002	11 X 16 cm area of local erythema on the right deltoid. Nonpainful, nonindurated patch of erythema over right deltoid.				Y					Y	11/04/2002	11/05/2002	1	NONE	PVT	PVT	Provan HCT, Dynacite, Lipitor,		Leukemia, Allergy			1						1	Injection site erythema	FLUX~UNKNOWN MANUFACTURER~U0929AA~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0192874	11/08/2002	OK	62.0	62		M	11/07/2002	Extreme erythema & increased temperature & palpitation to whole upper right arm where injection given -aches, sore										11/05/2002	11/05/2002	0		PVT	PVT	Soma, Lipitor, ASA, Darvocet, Capaten, Norvasc	NONE	CAD, Allergic to hydrocodone			1						1	Injection site erythema; Injection site warmth; Palpitations	FLU3~EVANS VACCINES~31902HA~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1351L~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192877	11/08/2002	MS	81.0	81		M	10/31/2002	81 year old white male in for flu and pneumonia. About 45 minutes later, patient began to feel sick at stomach (at friend's house), left to go home. When wife came home, he was lying on bed, cold and wet with sweat to touch, lips gray looking. complained of nausea and weakness. Wife called health department and was told to go to ER and call PMD and to let PHN know. She called back to say PMD told her to take patient to ER. PHN called patient back at 2:#0 PM. Wife said patient refused to go to hospital but is much better now; sitting up and eating. Stressed to her to take him to hospital if conditions worsens.									Y	10/31/2002	10/31/2002	0		PUB	PUB	None	None	None		MS02029	1						1	Asthenia; Hyperhidrosis; Nausea	FLU3~PFIZER\WYETH~4020030~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0445M~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192878	11/08/2002	LA	3.0	3		F	11/05/2002	Urticaria evening of office visit on legs and lower back. No SOP, no dyphagia. Rx - Benadryl.									Y	10/29/2002	10/29/2002	0		PVT	PVT		Possible URI	Atopic Child			1						1	Urticaria	FLU3~SANOFI PASTEUR~U0886AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192879	11/08/2002	MD	33.0	39		F	11/05/2002	24 hours after innoculation, chills, malaise, erythema at injection site, dizzy. Left deltoid pain 24 hours post injection on 11/02/2002. 11/03/2002 pain, chilled and miserable. 11/04/2002 site started to get red, slight dizziness. Took tylenol and slept.									Y	11/02/2002	11/03/2002	1	CBC with diff 11/5/02	PVT	PVT	Coumadin, Celexa	None	Mitral valve replacement, Depression, Obesity			1						1	Chills; Dizziness; Injection site erythema; Injection site pain; Laboratory test abnormal; Malaise	FLU3~SANOFI PASTEUR~U0872AB~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~3052L~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192880	11/08/2002	KY	27.0	26		F	11/04/2002	Received vaccine 10/07/2002 IM left deltoid. No swelling, redness or bruising at site. Pain progressively worse, tender over deltoid muscle--painful range of motion. DX: Left deltoid neuropathy, brachial neuritis. See by physician 11/4/02. Rx: Medrol dose pack, VIOXX.				Y					U	10/07/2002	10/15/2002	8		MIL	PVT	None	None	None			1						1	Injection site pain; Joint range of motion decreased; Neuropathy; Radiculitis brachial; Tenderness	FLU3~SANOFI PASTEUR~U0888AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192881	11/08/2002	IL	42.0	42		F	11/04/2002	Within 2 hours of vaccine administration, had metallic taste in mouth. At about 20 hours, left arm slightly sore, right arm very sore and worse with movement. 30 hours--weak, chills, no temperature, quarter size welt on right arm. By 40-48 hours, palm size arm, raised area on right arm. 68 hours - raised area from shoulder to elbow affected on right.										11/01/2002	11/01/2002	0	None	PUB	PUB	Allegra D, VIOXX	None	Hay fever, carpal tunnel			1						1	Asthenia; Chills; Injection site swelling; Urticaria	FLU3~SANOFI PASTEUR~U0903AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1353L~1~IM~RA~HEP B (FOREIGN)~1	USA		Influenza
0192882	11/08/2002	MD	83.0	83		F	11/04/2002	Left arm: 20cmx17cm area of erythema; increased heat, non-tender, NL strength and pulse. No edema, no fever or chills. Mild achiness; treated with Keflex, Benadryl. Dx - left arm skin reaction after flu/pneumovax. Cellulitis vs allergic reaction.				Y					Y	10/28/2002	10/29/2002	1	None	PVT	PUB	Zinc, Toprol, ASA, Evista, MVI, Zocor, Valium, Celebrex, Glucatrol XL, Trental	None	HTN, Hyperlipidemia, Type II DM			1						1	Feeling hot; Injection site erythema; Cellulitis; Injection site erythema; Injection site hypersensitivity; Injection site reaction; Injection site warmth	FLU3~SANOFI PASTEUR~U0930F~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0675M~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U0930F~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0675M~1~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0192883	11/08/2002	OH	45.0	44		F	11/04/2002	Swollen, red and itchy at injection site.									Y	10/23/2002	10/24/2002	1		PVT	UNK		None				1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U0930FA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192884	11/08/2002	WI	2.0	2	.0	M	10/15/2002	Took shot at 11:30AM. Went home and took a nap 10 minutes. Upon awaking he broke out in a severe case of hives. Took him back to doctors office. Was told to give him Benadryl every 6 hours. Break out lasted 3 days. Complete recovery.				Y					Y	10/08/2002	10/08/2002	0	None	PVT	OTH	None	Very mild cold	None			1						1	Urticaria	DTAP~UNKNOWN MANUFACTURER~~4~~~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0192885	11/08/2002	OH	56.0	54		F	10/30/2002	2:52pm went to get a drink of water-came back feeling faint-sat down checked BP 64/40 pulse 84. Cold compresses applied-skin clammy. Gave water to drink. 3:03pm feeling better BP 86/50. 3:10pm light-headed-laid down on floor-ice to neck. 3:12pm I'm okay now. -wants to sit. Advised to stay laying tx with feet up. 3:32pm sitting  BP 128/80 pule 96. Standing up feels ok now. 3:38pm pt left ambulatory with friend driving.									Y	10/30/2002	10/30/2002	0		OTH	UNK	Claritan, Synthroid, Memarin, Zartec	NONE	PCN			1						1	Cold sweat; Dizziness	FLU3~PFIZER\WYETH~4020012~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0192886	11/08/2002	TX	73.0	73		M	11/01/2002	Left arm red from elbow to deltoid. Area swollen and warm to touch.									Y	10/31/2002	10/31/2002	0	None	OTH	PVT		None	None			1						1	Feeling hot; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U0955AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1161L~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192887	11/08/2002	MO	54.0	54		F	11/04/2002	Sore throat/nausea in pm, joints swollen. 10/30 BP increase to 145/87. Last year flu shot had red whelp on arm at site of shot.				Y					U	10/17/2002	10/17/2002	0		PUB	PVT	Celebrex, Calexa	Root canal 10/10/02	Guillain Barre 1958		MO2002038	1						1	Joint swelling; Nausea; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U0882AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192889	11/08/2002	WI	57.8	57		M	11/06/2002	48 hrs after flu shot employee complained of fever T102 that lasted for 4 days (normal body temp 97). Relief only with Ibuprofen. Also complained of body aches and chills. Denied complaints of chest, lung or sinus congestion. Saw primary MD who did not do any testing.									Y	10/18/2002	10/20/2002	2	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Chills; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U0918AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192915	11/08/2002		76.0			F		It was received from a regulatory authority on 10/29/00, concerning a 76 year old female pt who experienced ischaemic heart disease resulting in death 2 days after receiving the Fluvirin vaccine on 10/13/02. On 10/15/02, two days after vaccination, the pt experienced ischaemic heart disease and died. A post mortem examination was performed and coronary artery disease was reported as the probable cause of death. The reporter has assessed the relationship of the vaccine to the events as having a direct or indirect association.	Y								N	10/13/2002	10/15/2002	2		UNK	UNK	NONE				PJP200200543	1						1	Myocardial ischaemia	FLUX~UNKNOWN MANUFACTURER~763459~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0192928	11/08/2002	GA	34.0	34		F	11/08/2002	pt received flu vaccine and 1 hour later had hive on back of hand approx 2-3 cm,itchy.No other complaints. Went to dr office, had redness at nape of neck Received Decadron and Medrol pack									Y	10/30/2002	10/30/2002	0		UNK	PVT	none	none	none			1						1	Erythema; Urticaria	FLU3~PFIZER\WYETH~4020019~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0192929	11/08/2002	VA	23.0	23		F	11/08/2002	Local reaction at injection site (Severe swelling, purple in color, hot to touch, extremely painful), Nausea and Vomiting, Diarrhea, Fever of 101.3 at highest, Dizziness, Headache, Body Pain, Weakness and Fatigue, Chills. All symptoms have lasted, at this time of report, for almost 48 hours so far.									U	11/06/2002	11/06/2002	0		PUB	UNK	None	None	NKDA, No other known allergies			1						1	Asthenia; Chills; Diarrhoea; Dizziness; Fatigue; Feeling hot; Headache; Injection site reaction; Nausea; Oedema; Pain; Pyrexia; Skin discolouration; Vomiting	FLU3~SANOFI PASTEUR~UO921AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192930	11/08/2002	CA	44.0	43		M	11/08/2002	Flu shot received around 10:15 am (11/6/02).  Aches noted by 3:00pm, chills by 4:00pm.  Went home early from work.  Sour stomach, threw up at midnight. Slept poorly. Tired and achy next day, able to hold down food and worked 4 hours. Never had such a reaction to a flu shot before.									Y	11/06/2001	11/06/2002	365		UNK	PVT	I take a multivitamin and mineral  supplement daily.	I felt fine,perfectly healthy	none			1						1	Chills; Pain; Stomach discomfort; Vomiting	FLUX~UNKNOWN MANUFACTURER~?~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192996	11/08/2002	OH	31.0	30		M	11/08/2002	Ringing in ears within weeks. Fatigue within weeks. Headaches. Nausea Hearing loss Balance disorders (Meniere's Syndrome) Memory loss.  Muscle pain Fatigue Vision Problem Treatment- Antivert, dizipan, water pills.				Y	Y	3		Y	N	06/06/1996	06/14/1996	8	MRI Balance test Shows Vistibular disorder Cat scan	MIL	MIL	B-Complex E IU 400	Problem started mild and became severe in July 2000 Dr. did not enter the shots in my records	Shellfish, Iodine			1						1	Amnesia; Fatigue; Headache; Hypoacusis; Meniere's disease; Myalgia; Nausea; Tinnitus; Visual disturbance	CHOL~UNKNOWN MANUFACTURER~~UNK~~~CHOLERA (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|MEN~SANOFI PASTEUR~~UNK~~~MENINGOCOCCAL (MENOMUNE)~1|YF~UNKNOWN MANUFACTURER~~UNK~~~YELLOW FEVER (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0192997	11/08/2002	CO	45.0	45		F	11/08/2002	Very swollen lymph glands in armpit, neck, and under jaw on same side as shot received.				Y					Y	11/02/2002	11/03/2002	1		PUB	UNK	Levoxyl, Loestrin 1.5/30, Lipitor,  Paxil, Trazodone	None	None			1						1	Lymphadenopathy	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0192998	11/08/2002	CA	50.0	49		M	11/08/2002	Got a flu shot in early January 2001.  Got the flu about third week in February 2001.  Took two weeks to recover from severe flu.  Mid-March (about a weeks after symptoms were gone) arms and legs started tingling and going numb with increasing severity.  Hospitalized and diagnosed with Guillain-Barre syndrome.  Treated blood with immunoglobins.  Some nerve damage in arms.				Y	Y	1		Y	N	01/07/2001	03/10/2001	62	Guillain-Barre Syndrome	UNK	PVT	Lipitor	None	High cholesterol			1						1	Guillain-Barre syndrome; Hypoaesthesia; Influenza; Paraesthesia	FLU3~SANOFI PASTEUR~E11941LA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0193004	11/09/2002	OH	53.0	53		U	11/09/2002	I was initially sick to my stomach so I went to bed early.  I suddenly received a severe bout of vertigo, which I had never experienced before. My bed seemed as if it was turning and falling, the whole room seemed to spin.  I closed my eyes to try to stop the spinning, but it continued and I felt like I was going to get sick. This happened several times during the night if I turned my head.  I tried not to move during the night.  I do not know if it had anything to do with the vaccine, but since I had taken the vaccine that morning and had never been sick like that from taking the Influenza Vaccine, or any other time,I thought I would report it.  The next day, (today) I am a little dizzy but nothing like how I felt last night.    I did not go to the hospital or doctor and probably won't unless I get another case of the severe dizziness.									Y	11/08/2002	11/08/2002	0		UNK	UNK		No				1						1	Dizziness; Stomach discomfort; Vertigo	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193006	11/10/2002	CO	26.0	26		F	11/10/2002	10 minutes after flu shot patient complained of warmth in her total body.  Patient became dizzy and felt like her hands were swelling. Patient became nauseated and then vomited.  She then felt like her airway was closing.  RN evaluation found the patient vomiting, face flush, Hear rate 144, resp rate 22.  Benadryl 50mg po given per standing orders.  911 called due to patients describing the feeling her throat was swelling.  No acute resp distress evident.  Vital signs recheck P 92, R 20 B/P 132-100.  Paramedics arrived and transported patient to Hospital ED for evaluation.  Patient evaluated and released on 11/8 with diagnosed of Allergic Reaction.				Y					Y	11/08/2002	11/08/2002	0		PUB	PVT	unknown	None	unable to reach patient unknown			1						1	Dizziness; Feeling hot; Hypersensitivity; Nausea; Oedema; Respiratory distress; Vomiting	FLU3~SANOFI PASTEUR~UO920AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193007	11/10/2002	CO	58.0	58		F	11/10/2002	Patient received her flu shot prior to her appointment for a screening mammography.  She has received flu shots yearly without problems.  During her mammogram procedure, she suddenly felt lightheaded and nausea.  Thought she was going to get sick.  She sat for a few minutes, drank some juice and then felt better.  Client did not appear to be anxious about her mammogram.  Vital signs were normal.  Spoke to patient today 11/10, she is feeling fine.  Denies any symptoms or adverse affects today.  VAERS form submitted due to the sudden onset on feeling light headed and nausea.									Y	11/07/2002	11/07/2002	0	none	PUB	PVT	Unknown	None	Unknown			1						1	Dizziness; Nausea	FLU3~SANOFI PASTEUR~UO920AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193008	11/10/2002	CO	39.0	39		F	11/10/2002	Patient received her flu shot, then her daughter received her shot.  They sat in the lobby for 15-20minutes due to first time flu shot for her daughter.  They had checked back in with the nurse and was released to go.  They were outside when she suddenly had chest discomfort/tightness, began to sweat and became very nauseated.  911 called, client evaluated 12 lead EKG negative, released to go home.  Spoke to client today 11/10, she stated that yesterday she develop a rash on her left shoulder and back, the rash later disappeared and she developed some swelling to the left side of her neck and burning sensation in her left shoulder.  She still has the burning sensation slightly today and mild swelling in her neck.  Denies difficulty breathing or swallowing.  She also has mild sore throat, low grade fever and body aches today. Denies any chest discomfort. Client has received flu shots in 2001 & 2000 without problems.  Denies feeling ill that day, no allergies to eggs									N	11/07/2002	11/07/2002	0	None	PUB	PVT	Niacin 500mg daily, Lasix, Vitamin B & E, Gignko, grapeseed extract & CoEnzyme 10.  Has been taking these medications for 5 years	None	Meniere's Disease			1						1	Chest discomfort; Hyperhidrosis; Nausea; Oedema; Pain; Pharyngolaryngeal pain; Pyrexia; Rash	FLU3~SANOFI PASTEUR~UO920AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193009	11/10/2002	CO	29.0	29		F	11/10/2002	1.5 hours after receiving her flu shot she developed sudden tingling and numbness in her chin and lower jaw. No hives or rash. No symptoms of throat swelling. No hoarness or wheezing.  Symptoms isolated to her jaw.  Spoke with client today 11/10.  She is doing fine symptoms are gone.  They lasted for several hours after her flu shot.  She last had a flu shot 4 years ago									Y	11/07/2002	11/07/2002	0	none	PUB	PVT	Unknown	None	None			1						1	Hypoaesthesia; Paraesthesia	FLU3~SANOFI PASTEUR~UO920AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192931	11/11/2002	IL	11.0	11		F		Administered 10/18/02. Developed URI 10/23 migraines with headache, vomiting. Progressed to encephalitis with hospital admission 10/25. Doing fairly well. Onset seizures 10/26. Transferred to another facility. Recurrent seizures. Herniation brain. Death.	Y	10/28/2002							N	10/18/2002	10/23/2002	5	CSF 114 94%, CIE-nl, original nl CT/MRI brain. 10/27 herniation.	PVT	PVT	OTC, Afrin, Valine	NONE	History of recurrent sinusitis. Asthma, Meningoencephaitis Viral			1						1	Convulsion; Encephalitis; Headache; Migraine; Upper respiratory tract infection; Vomiting	FLU3~SANOFI PASTEUR~U0910AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0192934	11/11/2002	NM	27.0	27		M	11/01/2002	Swelling, redness, rash, unable to straighten arm completely, skin is hard, redness in bicep and upper chest area.										10/30/2002	10/30/2002	0		MIL	MIL		No				1						1	Erythema; Injection site induration; Joint range of motion decreased; Rash; Swelling	ANTH~EMERGENT BIOSOLUTIONS~FAV063~7+~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U0783AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192935	11/11/2002	FL	46.0	46		M	11/10/2002	Within twelve hours of receiving the vaccine, low ? followed by fever up to 104 accompanied by chills, ? headache peaking on the fourth post-vaccine days a ? Vaccine manufacturer, type is unknown. Infl?									Y	10/26/2002	10/26/2002	0		PUB	UNK	Allopurinol, Bactrim, ASA, Multivitamin	None	None			1						1	Chills; Headache; Pyrexia	FLU3~PFIZER\WYETH~~4~IM~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0192936	11/11/2002	TX				F	11/08/2002	Dizziness and numbness and headaches shortly after receiving immunization. No SOB or rash. Given Benadryl and EMS called. Patient transported to ER. Back to regular work time next day.				Y					Y	11/07/2002	11/08/2002	1		OTH	PVT		None	None			1						1	Dizziness; Headache; Hypoaesthesia	FLU3~EVANS VACCINES~E330704HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0192938	11/11/2002	UT	31.0	31		F	11/08/2002	Hives on upper arm where shot given 2nd lower torso.									Y	11/07/2002	11/07/2002	0		OTH	PVT						1						1	Urticaria	FLU3~SANOFI PASTEUR~U0920AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192939	11/11/2002		40.0			F		An ASSP was received from a regulatory authority on 10/29/00, concerning a 40 year old female patient who experienced a metallic taste at the back of her mouth and a tingling sensation on the tip of the tongue which was considered to be medically significant after receiving the Fluvirin vaccine on 10/10/02. The patient has a medical history, a penicillin allergy and an allergic reaction to aspirin. The patient was also received solpadol concomitantly. On 10/10/02, 10-20 seconds after the vaccination, the patient complained of a metallic taste at the back of the mouth and tingling sensation on the tip of her tongue. There as insufficient information to determine the reporter's causality assessment. The reporter considered the metallic taste and tingling sensation to be medically significant as further immunization could cause problems.										10/10/2002	10/10/2002	0		UNK	UNK	Solpadol				PJP200200546	1						1	Dysgeusia; Paraesthesia	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0192940	11/11/2002	WY	48.0	48		F	10/31/2002	Patient was experiencing same feeling in my throat that I had when I ate shrimp and found out I was allergic to it. Benadryl IM administered. Lung sounds clear bilaterally. No relief from Benadryl. Adrenaline SC. Lung sounds remains clear. Experienced shaky feeling, headache and high blood pressure over next hour. Went from 180/110 to 200/90 to 140/60 with a constant pulse of 100. Went home with friend and told to contact a911 if any symptoms reappeared.									Y	10/30/2002	10/30/2002	0	None	PUB	PUB		None	Diabetes, Asthma, Lung problems, Allergies to shrimp, Niacin and others.			1						1	Headache; Hypersensitivity; Hypertension; Tremor	FLU3~PFIZER\WYETH~4020034~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0192941	11/11/2002	IA	58.0	58		F		Pt was very fatigued the day after she received the pneumo shot. On Sunday, 2 days after receiving the shot she woke up with severe hives, fatigue, very sore arm and believed shortness of breath. Md advised and steroid shot was given after no success with Benadryl.				Y					N	10/25/2002	10/26/2002	1		OTH	PVT		NONE				1						1	Dyspnoea; Fatigue; Injection site pain; Urticaria	FLU3~PFIZER\WYETH~4020018~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0735M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192942	11/11/2002	MD		76		F		Patient had flu shot 10/23/02 in left arm. Pt came in on Saturday 10/26/02 with massive hematoma from shoulder to elbow. This hematoma did not appear until thursday evening as per pt.  I referred pt immediately to family doctor. Doctor said artery was nicked. I contacted Health Events on Saturday and also gave pt's doctor the info, as well as the pt. I contacted the visiting nurse association and the Wyeth Drug company.										10/23/2002	11/01/2002	9		UNK	UNK						1						1	Injection site haemorrhage	FLU3~PFIZER\WYETH~4020017~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0192943	11/11/2002	WI	11.0	11		F	11/05/2002	11 year old walked into clinic to receive flu vaccine. Denies any allergies to eggs or prior problem with flu shots. 15 minutes following injection, patient complained of body aches, tingling in feet, and fever 99.5 oral; BP - 110/80. Patient was flushed in appearance. Patient given diphenhydramine 50mg orally and sent to ER.					Y					10/30/2002	10/30/2002	0	None	PUB	UNK	Albuterol; Cyclocort		Latex allergy/Rash			1						1	Flushing; Pain; Paraesthesia; Pyrexia; Flushing; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U0928AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~UO928AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0192944	11/11/2002	VA	39.0	39		F	11/05/2002	Received a flu shot--Influenza Virus Vaccine - Fluzone and within 24 hours of shot, the soreness went away, but was replaced by muscle pain and an uneven reddened area appeared below the site, approximately 3-4 in length and widened throughout 11/01/02. Saw medical doctor who prescribed Keflex								Y		10/30/2002			Unk	UNK	UNK						1						1	Injection site erythema; Injection site pain; Myalgia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0192945	11/11/2002	IL	32.0	32		F	10/28/2002	Dizziness, lightheadedness, nausea, vomiting, sensitive to light, headache, ear ache, unsteady gate. Treated with Valium, Prednisone, Mecklizie, bed rest.				Y					N	10/09/2002	10/17/2002	8		PUB	PVT		None	None			1						1	Dizziness; Ear pain; Gait disturbance; Headache; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U0888AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192946	11/11/2002	MA	24.0			F	11/04/2002	After receiving influenza vaccine, she reported significant erythema and multiple hives around the injectionsite. No other systemic effects noted.										10/22/2002	10/22/2002	0		UNK	UNK	Micro-loestrin		Latex Allergy			1						1	Injection site erythema; Urticaria	FLU3~EVANS VACCINES~E34102HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0192947	11/11/2002	MA	57.0	57		F		Patient came to clinic status post ER cellulitis of the left arm. Received PCV23 and flu shot on left arm. Patient stated it was very swollen and painful.				Y					U	11/01/2002	11/01/2002	0	CBC ESR	PUB	OTH	None		Diabetes, HTN, Sceroderma			1						1	Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U0969AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0923L~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192948	11/11/2002	IN	38.0	38		M	11/03/2002	Received shot in left arm 10/6 about 10:30AM. By that evening 100 degree temperature, left arm throbbing. Arm continued to throb the entire next day. Temperature 99-100. By Monday 10/8 spoke to family doctors office. Monday evening, noticed rash on left upper chest. On 10/11 diagnosed with herpes zoster.				Y					Y	10/06/2002	10/08/2002	2	None	MIL	MIL	None	None	None			1						1	Herpes zoster; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U0880AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192949	11/11/2002	ME	68.0	68		F	10/30/2002	Received Pneumonia vaccine right deltoid 10/29/02 @ health department, Developed warmth, redness and swelling @ injection site within 4-6 hours after injection, states was size at egg, When examined on 10/30//02, had redness, increased warmth and slight swelling @ injection site. Redness was approx 2 inches diameter.									Y	10/29/2002	10/29/2002	0		PUB	PUB		NONE			MS02030	1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~PFIZER\WYETH~402002L~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0735M~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0192950	11/11/2002	PA	52.0	52		M	11/01/2002	Less than 20 minutes following administration of influenza vaccine, individual complained of feeling funny in the head, face and arms became rosy red and small hives began appearing. Gave epinephrine  in left arm SC. Took to ER for evaluation. Per ackn. letter: took to ER as precaution, but when family members advised they took him home woithout being seen by ER physician.				Y					Y	10/31/2002	10/31/2002	0		OTH	OTH	9 medications	None	Diabetees, HBP, depression		PA0235	1						1	Erythema; Urticaria	FLU3~SANOFI PASTEUR~U0874AB~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192951	11/11/2002	KY	82.0	82		M	11/04/2002	Immediate pain to left shoulder, Saw private physician, Tests to determine any damage shoulder, Physical therapy weekly				Y					U	10/07/2002	10/07/2002	0		OTH	OTH		NONE Known				1						1	Injection site pain	FLU3~SANOFI PASTEUR~U0886AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192952	11/11/2002	MI	78.0	78		F	10/31/2002	Redness, swelling, tenderness to site, ? early cellulitis vs leg local reaction				Y						10/29/2002	10/31/2002	2		PUB	UNK						1						1	Cellulitis; Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U0881AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0134M~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192953	11/11/2002	SC				U		Client received Td and flu on 10/11/02 around 11 AM or 1 PM. At 9 pm, she experienced slight fever, slight swelling & itching of arm where Td was given. These symptoms were more pronounced 24 hours later. She presented at health department on 10/15/02 with left arm red & swollen to elbow. She was referred her private doctor who diagnosed cellulitis and advised Keflex and a topical ointment 10/16/02. She reports improvement and will see doctor on Monday.				Y					Y	10/11/2002	10/11/2002	0		PUB	PUB		NONE	NKA		SC0246	1						1	Injection site erythema; Injection site reaction; Injection site swelling; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~UO921DA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TTOX~SANOFI PASTEUR~UO524AA~UNK~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0192954	11/11/2002	TX	68.0	68		F	11/04/2002	Left upper arm swollen onset Saturday am 11/02/2002. Left upper arm from shoulder to elbow swollen, warm, and painful. ER sweeny 11/03/2002- warm compresses Rx Keflex Tylenol PrN				Y					U	11/01/2002	11/02/2002	1	NONE	PVT	OTH	Premarin, Calcium, Zantac, HCT2, Lipitor	NONE	HTN, Increase cholestrol, allergies Codeine and PCN			1						1	Feeling hot; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U0954AA~5~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0172M~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0192955	11/11/2002	MI	59.0	59		M	11/04/2002	Dizziness, Fainting feeling, Could not focus eyes for 2-3 min									Y	10/28/2002	10/28/2002	0	NONE	PVT	OTH	NONE	NONE	NKA			1						1	Dizziness; Staring	FLU3~PFIZER\WYETH~~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0192956	11/11/2002	FL	1.0	1	.0	F	11/04/2002	Vaccinated 10/09/2002. On 10/15/2002 macules papular rash on thighs and abdomen with ? candela dermatitis. Tx with Benadryl po and Lotrimin topically. 10/22 rash noted that comes and goes along with tinea capitis Tx with Griseofulvin 10/28 seen with rash- told to stop Grisenfulvin. Papules with vesicles that come and go. Thought to have varicella 2 hours after vaccine. Refer to I. D. Dr. 10/30/ Infectious Disease consulted who Dx varicella vaccine adverse event along with Tinea Capitis. Rash presented still on 10/30/2002, but was resolving.				Y					N	10/09/2002	10/15/2002	6	Refer to I.D. for consult on rash.	PUB	UNK	Tegretol 4mg TID, Augmentin, Griseofulvin	Billotitis Media, Diarrhea, Tinea Capitis	Complex partial seizures			1						1	Dermatitis; Infection; Rash macular; Rash papular	FLU3~PARKDALE PHARMACEUTICALS~877AA~1~~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|HIBV~SANOFI PASTEUR~1689AA~4~~RA~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~1486L~1~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0326M~1~~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0192957	11/11/2002	GA	70.0	70		F	11/02/2002	Had chills, Mon, Tue nights, Felt bad, sluggish, Neck sorta stiff, Fever (Mon) 101.2, Dull Headache, 3 lumps behind right ear (gone 2 days later)									Y	10/21/2002	10/21/2002	0		PUB	PUB	Hormones. Synthroid only	NONE	NKA			1						1	Headache; Lethargy; Lymphadenopathy; Musculoskeletal stiffness; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192958	11/11/2002	IN	4.5	4		F	10/31/2002	Mother took child to ER d/t swelling right deltoid area, MD wrote right deltoid region warm to touch, erythematous, mildly indurated, no streaking, Dc'd with instructions to apply ice, hydrocortisone cream 2X 5 qd and may give Benadryl orally.				Y					Y	10/25/2002	10/27/2002	2		PUB	PUB	Alb prn/ Neb, None that day	NONE	NKDA, RAD, Vesicoureteral reflux, uretaral implants			1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth	DTAP~SMITHKLINE BEECHAM~574A2~5~IM~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UO909AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~U0010~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~063TM~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0192959	11/11/2002	CO	1.0	1	.0	F	11/04/2002	Raised 3cm x 3cm area at injection site									Y	10/29/2002	10/30/2002	1	NONE	PVT	PVT		NONE				1						1	Injection site swelling	DTAP~SANOFI PASTEUR~C0889AA~1~~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U0945AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0389M~3~~RA~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0023M~1~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0419M~1~~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0192960	11/11/2002	ND	22.0	22		F	10/31/2002	22 hours after receiving the flu vaccine she experienced a headache, weakness, achiness, and paleness with nausea. I saw her the next day, approx. 48 hours after adm. of the flu vaccine. At that time the headache was improved. She still felt shaky and was pale. No local reaction was experienced. Called the health dept said that symptoms were unrelated to flu vaccine. Will reevaluate next fall before getting the flu vaccine. No allergy to eggs.									Y	10/23/2002	10/24/2002	1		PUB	PUB	NONE	NONE	NONE		ND0218	1						1	Asthenia; Headache; Nausea; Pain; Skin discolouration	FLU3~PFIZER\WYETH~4020025~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0192961	11/11/2002	IA	79.0	79		F	11/04/2002	2 days after receiving flu injection, pain down left arm; Tried heat, elevation, also started getting discomfort in neck, Osteopathic treatment to cervical area									U	10/17/2002	10/19/2002	2	NONE	PVT	PVT	Verapamil 180 mg qd,Baby ASA, Lasix 20mg qd	NONE	Niaon/sulfa, Necxium allergies,colon CA			1						1	Injection site pain; Neck pain	FLU3~SANOFI PASTEUR~UO882AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192962	11/11/2002	IL	36.0	36		F	10/26/2002	Vaccine was administered 10/9/02 at approximately 2pm. On 10/10/02 when I got up, I had severe vertigo. The vertigo worsened. On 10/12/02 I went to the emergency room. I had rotational & horizontal nystagmus, nausea, vomiting, inability to ambulate. Positive nylonberone manuever (per neurologist). To date (10/26/02) I still have a degree of vertigo, imbalance and nystagmus.				Y					N	10/09/2002	10/10/2002	1	CT Head, MRI and IAC were done, both were normal. See Documentation from neurologist and emergency room.	PUB	PVT		NONE	UNK			1						1	Nystagmus; Vertigo	FLU3~SANOFI PASTEUR~U0888AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192963	11/11/2002	AL	60.0	60		F	11/01/2002	Reddened hot area around injection site, approx 3 x4									N	10/30/2002	10/31/2002	1	Doctor ordered Zyrtec & ice 11/01/02, On 11/04/02, area no longer reddenned or hot.	PVT	PVT	NONE	NONE	NKA			1						1	Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~UO888AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192964	11/11/2002	MA	73.0	73		F	11/01/2002	Pt reported 11/01/02 AM, Pt c/o pain to upper arm and weakness in arm and hand grasp. Pt had soreness in upper arm after injection given but it has increased over the last two weeks. Swelling or redness in upper arm. Right hand grasp weakness than left. pt had take Tylenol and warm compresses to upper arm.									U	10/08/2002	10/10/2002	2	NONE at this time	OTH	PUB	Glucophage 1 gm po qd, Lipitor 10 mg qd po, Glucotrol XL 5 mg PO qd, Norvasc 5 mg po qd	NONE	NKA			1						1	Injection site erythema; Injection site pain; Muscular weakness	FLU3~SANOFI PASTEUR~UO879AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0923L~UNK~IM~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0192965	11/11/2002	GA	62.0	62		F	10/29/2002	1055am 4-5cm area of erythema. Ice applied 1cm hematoma. 1125am expanding are of erythema and edema 10cm, ice held. 1135 less erythema, no tenderness, no warmth.									Y	10/29/2002	10/29/2002	0		PVT	UNK		NONE	HTN, hypocholesteremia, schizophrenia, HA			1						1	Erythema; Haematoma; Oedema	FLU3~EVANS VACCINES~E34722HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0192967	11/11/2002	IA	64.0	64		F	10/24/2002	This is an adult patient of Dr. who is coming in today with receiving the flu vaccine yesterday. At 2:00am she woke up complaining of left axilla pain. She also has red streaks going down her left arm. She was out picking tomatoes yesterday, so it is hard to know what is actually triggering this. The actual injection site is not red. It is slightly swollen. Female in no acute distress. Weight 130. Temp 96.5 BP 164/92. Pulse 80. I do believe more of the elevated BP is due to her dsicomfort and worry about the streaks on her arm. She has red streaks that start on the top of her hand, go up her forearm, and up underneath her axilla. She does have a swollen lymph node up under there. We did draw a black circle around this. We don't actually see a site on her hand. I would suspect there is somethin microscopic there. We did see the site for the flu shot. It is swollen but no redness. Cellulitits. Keflex 500mg TID for 10 days and Zyrtec just to insure there is not an allergic reaction going on. She will follow-up with Dr. or us on Friday and sooner if it starts to spread, swell or anything gets worse. She was instructed to ether see us or go to the ER.				Y					Y	10/21/2002	10/22/2002	1		PUB	PUB	NONE	NONE	NONE		IA02016	1						1	Injection site swelling; Pain	FLU3~SANOFI PASTEUR~U0929AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192968	11/11/2002	OH	51.0	51		F	11/08/2002	Woke up around 3:00 am with swollen chin and lower face. Took an Allegra tablet. face started to go down around 09:00am the same day.									N	11/07/2002	11/08/2002	1		PUB	OTH		Low grade cold	On going problem with allergic reactions esp to preservatives			1						1	Face oedema	FLU3~SANOFI PASTEUR~U0958AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192971	11/11/2002	TX	63.0	63		F	11/08/2002	Fever, difficulty breathing, large red sore area around shot area. Red sore spots away from shot area. Muscles aches. Coughing. Started trying to call MD 3rd day after shots. It was the weekend, MD called on Sunday asked for antibiotics and said that If I has the flu- there was nothing he could do . Monday his office called and said I could come in. I saw no reason to go in if there was nothing they could do. Both shots were given in same place. I don't know which one I had a reaction from.									U	10/30/2002	10/31/2002	1		PVT	PVT	NONE		NONE			1						1	Cough; Dyspnoea; Injection site erythema; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0192973	11/11/2002	ME	34.0	33		F	11/08/2002	2 inch X 3 inch area, Swollen, warm to touch, painful									Y	11/07/2002	11/07/2002	0		OTH	PUB	NONE	NO	sinus allergies			1						1	Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~UO904CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193012	11/11/2002	CA	47.0	47		M	11/08/2002	Within one hour a headache. Within two hours-weakness, dizziness and fatigue. Within 4 hrs-passed out. On Mond. October 10-donated plasma. On Tuesday noticed a bump under right arm pit. On Wednesday- bump was reduced to half the size.									U	10/21/2002	10/21/2002	0		UNK	UNK						1						1	Asthenia; Dizziness; Fatigue; Headache; Loss of consciousness; Subcutaneous nodule; Dizziness; Fatigue; Headache; Hyperhidrosis; Loss of consciousness; Nausea; Pollakiuria	FLU3~EVANS VACCINES~E35722HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|UNK~UNKNOWN MANUFACTURER~~UNK~~~VACCINE NOT SPECIFIED (NO BRAND NAME)~2	USA		Influenza
0193013	11/11/2002	CA	62.0	62		F	11/11/2002	Developed a cold and rash. Hives on back of leg. Tiredness.									N	11/08/2002	11/08/2002	0		UNK	UNK						1						1	Fatigue; Pharyngitis; Rhinitis; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193014	11/11/2002	OR	48.0	48		F		Eyes bloodshot, headache, achy-diff breathing-sinus swelling. Slept-hives on face, stiff neck. Tx Benadryl.				Y					U	10/23/2002	10/23/2002	0		PVT	UNK	Topramax	NONE	? disroder, seizures, food allergies			1						1	Dyspnoea; Headache; Musculoskeletal stiffness; Ocular hyperaemia; Oedema; Urticaria	FLU3~SANOFI PASTEUR~U0920AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193015	11/11/2002	NY	38.0	38		F	11/08/2002	Radiating pain from shot location down into elbow-started within 4-5 hrs.									U	11/04/2002	11/04/2002	0		OTH	PVT	Asthar, Flovent, Vits, Neuronton, Alupent and Allegra	NONE	Asthma, allergy sulfa/pcn			1						1	Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193024	11/11/2002	GA	19.0	19		F	11/06/2002	Swelling of entire arm, hands, face; rash on arm; complete stiffness of arm, neck and head (loss of movement) and fever.				Y					Y	11/06/2002	11/06/2002	0	NONE	UNK	UNK	Ortho-Tricyclen; Effexor	NONE	Sonata			1						1	Face oedema; Hypokinesia; Joint stiffness; Oedema; Oedema peripheral; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U0922AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0111M~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193029	11/11/2002	TN	41.0	41		F	11/08/2002	Large red welt on arm at site where vaccination (pneumo shot) was administered. Slight fever. Physician's diagnosis cellulitis. Site is warm and sore to touch.				Y					U	11/05/2002	11/06/2002	1	NONE	UNK	UNK		NONE	Allergic rhinitis, GERD, depression, Sciatica			1						1	Cellulitis; Injection site pain; Injection site reaction; Injection site warmth; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U0875AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0735M~2~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193034	11/11/2002	CT	42.0	42		F	11/11/2002	Itchy rash developed over entire body 2 1/2 hours after receiving flu immunization.  Pt. took 50 mg Benadryl with no effect.  Continued taking 50-75mg Benadryl every 4-6 hours with relief but rash kept recurring after 4-6 hours.  Patient was treated with prednisone dosepak.  It got worse the following day, and she was given more prednisone but it caused stomach pain.  Five days after receiving the shot, she went to the ER and was given cortisone IV with very little improvement.  Was seen by allergist who increased prednisone to 40mg x 5 days and taper off.  8 days after shot, patient feeling better but still symptomatic.				Y					Y	10/30/2002	10/30/2002	0		UNK	UNK			Seasonal allergies			1						1	Abdominal pain; Rash pruritic	FLU3~EVANS VACCINES~E32972GA~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0193035	11/11/2002	CO	73.0	73		F	11/11/2002	RN was conducting a call back on her husband who had received a flu shot and had complained of a tingling/pain in his arm, he has MS.  (Adverse form not submitted).  During the conversation, patient had indicated that his wife had not felt well after her flu shot.  Information related as follows to RN.  24 hours after receiving her flu shot patient stated she had bumps on the base of her tongue and a strange feeling in her throat and the roof of her mouth.  States she very much felt like something was wrong.  Call back took place on 11/7/02, patient stated at that time her symptoms were gone.  Attempted to reach client 11/10/02 unsuccessfully.  Succesfully reached the client today. In revewing her syptoms she indicated that she had itching on her back on the evening of 11/6/02, they were gone by the morning of 11/07.  Approximately around 8am on 11/7, as they were driving, her throat suddenly became scratchy and tight, denies difficulty breathing or swallowing.  She drank water, took a mint to help but she felt like something was caught in her throat, she felt like she needed to clear her throat frequently.  She was frighten and almost turned back.  Eventually the symptoms disappeared but came back later that night.  Today her throat is still a little scratchy but is able to drink and talk without difficutly.  On 11/7, she was advised to take Benadryl which she did and it help.  Advised client to call  if symptoms become worse or to call 911 if her throat feels tight.  This was her first flu shot.  She denies an allergy to eggs, but the smell of eggs nauseate her.  She received a pnuemonia vaccine one year ago without problems									Y	11/06/2002	11/07/2002	1	none	PUB	PVT	takes several medications	none	none,  several allergies to medications, Valium, Darvon Iodine			1						1	Pain; Paraesthesia; Throat tightness	FLU3~SANOFI PASTEUR~UO920AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193037	11/11/2002	CO	31.0	31		F	11/11/2002	High fever, nausea, headache, extreme joint and muscle pain. Took 1000 mg of Tylenol twice daily for pain (slightly reduced pain). Symptoms lasted 48 hours.									Y	10/31/2002	11/01/2002	1		PUB	UNK	Loestrin, Levbid	No	Allergies- cow milk			1						1	Arthralgia; Headache; Myalgia; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193030	11/12/2002	CA	81.0	81		M		On 11/7 had flu vaccine. On 11/8 brought by pneumoia post grand mal episode. Brain CT, cardiac w/u neg. Observed for 24 hours no previous episodes.					Y	1			Y	11/07/2002	11/08/2002	1	Brain CT- normal, Cardiac enzymes, EKG- normal, CMP- normal	PVT	UNK	HCTC, allergy medicine	NONE	HTN, gout, NKDA			1						1	Grand mal convulsion	FLU3~SANOFI PASTEUR~U0875AA~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0193043	11/12/2002	GA	1.5	1	.5	F	11/11/2002	Both thighs all the way to feet red and swollen, crying, irritable.									Y	11/11/2002	11/11/2002	0	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Agitation; Erythema; Irritability; Oedema peripheral	DTAP~SMITHKLINE BEECHAM~573F9~4~IM~RL~DTAP (INFANRIX)~1|FLU3~EVANS VACCINES~E35732HA~1~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~W0010~3~IM~RL~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0193044	11/12/2002		28.0			F		A report was received from a consumer on 10/11/02, concerning a 28 year old female who experienced a painful, swollen and red hot elbow which was considered medically significant, 2 hours after receiving Fluvirin on 10/9/02. The vaccinee reported that she had no history of joint pain. On 10/9/02, the vaccinee received Fluvirin in the deltoid region of her arm. Her arm became painful after 2 hours, and continued to be painful, red and hot despite the application of ice packs to the area. The area also began to swell, which made it difficult for her to bend her arm. The vaccinee attended an ER  where she was prescribed an anti-inflammatory agent. By 10/11/02, the swelling had reduced but she was still experiencing pain with the area remaining red and hot. The vaccinee was planning to see her doctor again on 10/12/02. The vaccinee had not recovered at the time of reporting. The reporter has assessed the relationship of study medication to the event as possible. The vaccinee has not provided details of her physician.  Follow up on 01/29/2003: A report was received from the consumer indicating that the injection site was very painful for 24 hours following vaccination and that the left elbow was swollen with fluid.  The vaccinee received ER treatment with steroids on 10/12/2002.  Symptoms were reported as resolved on the 10/15/2002 after 48 hours treatment with steroids.									N	10/09/2002	10/09/2002	0		UNK	UNK	Ortho-tricyclin				PJP200200494	1						1	Feeling hot; Injection site erythema; Injection site pain; Injection site swelling; Joint range of motion decreased	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0193046	11/12/2002	NY	66.0	66		F	11/12/2002	Shot was administered at 11:30 a.m. At 3:30 p.m. my left upper arm experienced intense pain.  The pain came on IMMEDIATELY and SEVERELY.  The muscle has been frozen and pain has been experienced since.  Now it is Tuesday 11/12/02 and the area is tender touch, still frozen in movement and pain is still severe.  A doctor has been called today, 11/12/02, and a visit is scheduled for 2:45 p.m. this afternoon. The follow up states adverse reaction-pain, and lack of mobility. 11/8/02 the pain is gone and mobility returned after use of ibuprofen andmuscle relaxent for several weeks 12/16/02. There was no adverse reaction where the influenza vaccine was administered.				Y					U	11/08/2002	11/08/2002	0	unknown (Doctor visit scheduled for 11/12/02 at 2:45)	PUB	PUB	Lopid, Colestid, Fosamax, Multi-Vitamin, Calcium, low dosage asprin	NONE	Hyper-cholesteral			1						1	Hypokinesia; Pain; Tenderness	FLUX~UNKNOWN MANUFACTURER~unknown~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0873M~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193047	11/12/2002	NY	26.0	26		F	11/12/2002	dizziness, hearing  and vision (tunnel vision) impairment, speaking impediment (stuttering, etc.), thought processes are unclear and hazy, memory affected, flushed, cold hands, nervousness and unsteady walking										11/12/2002	11/12/2002	0		UNK	PUB	none	no	no			1						1	Cognitive disorder; Dizziness; Flushing; Gait disturbance; Hearing impaired; Nervousness; Peripheral coldness; Speech disorder; Visual disturbance	FLU3~SANOFI PASTEUR~U0879AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193048	11/12/2002	KS	82.0	82		F	11/12/2002	shot given in left del. 24 hours later patient had redness and warm in whole upper arm.  patient seen by doctor on 11-12-02 pt was put on keflex and predisone									Y	11/11/2002	11/12/2002	1		PVT	UNK	calcium, questran and fosamax	none	allergic to motrin pseudothrombocytopenia--11-21-00 pud			1						1	Erythema; Feeling hot	FLU3~SANOFI PASTEUR~u0946aa~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0873m~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193185	11/12/2002	ND	31.0	31		F	11/12/2002	Patient developed a painful lump at the site of injection, which persisted for four weeks.				Y					Y	10/01/2002	10/02/2002	1	None	MIL	MIL	None	None	None			1						1	Injection site mass; Pain; Injection site mass	FLU3~SANOFI PASTEUR~U0880AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0880AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0193186	11/12/2002	AL	38.0	38		F	11/12/2002	Experienced dizziness, nausea, and drowsiness.									N	11/07/2002	11/10/2002	3		UNK	UNK	Prozac	None known	NKDA	Tetanus~Tetanus Toxoid, adsorbed (no brand name)~1~25.00~In Patient		1						1	Dizziness; Nausea; Somnolence	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193187	11/12/2002	PA	46.0	46		M	11/12/2002	Shot administered on 6 November 2002 Swelling left arm joint pain left arm.  Swelling started to go down after 48 hours. After swelling went down lump remained at site of vaccination. member is now itching at the site of swelling.									N	11/06/2002	11/08/2002	2		MIL	MIL	None		None			1						1	Oedema; Pain; Pruritus	ANTH~EMERGENT BIOSOLUTIONS~FAV 064~7+~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~uo983aa~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192943	11/13/2002	WI	11.0	11		F	11/13/2002	Patient came to clinic to receive flu vaccine.  Denied any allergies to eggs or prior problems with receiving flu vaccine.  Patient reported feeling in good health prior to vaccine.  Fifteen minutes following injection, patient complained of body aches, tingling in feet, and fever (99.5 F- oral).  BP = 110/80.  Patient was flushed in appearance.  Patient was given diphenhydramine 50 mg orally and sent to emergency department.  Upon presentation in the emergency department, her temperature rose to 102.3 F.  Patient was given acetaminophen 650 mg orally in the emergency department, in addition to oral fluids. Both were tolerated well.  The emergency department did not feel this event was related to the flu shot/allergic reaction.  They diagnosed her with an unrelated viral etiology.  Later in the emergency department, the patient appeared to be feeling better, her fever improved, and she was discharged home.				Y					Y	10/30/2002	10/30/2002	0	See #7 above.	PVT	PVT	None	Feeling healthy prior to vaccination.	Asthma, eczema			1						2	Flushing; Pain; Paraesthesia; Pyrexia; Flushing; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U0928AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~UO928AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0193064	11/13/2002	GA				M	11/08/2002	Information has been received from a physician concerning a male pt with history of hypercholesterolemia, coronary artery disease and squamous cell carcinoma of the right eye, who on 10/27/02 was vaccinated with a dose of Fluzone SV '2002-'2003 (lot number unspecified). The pt developed hematochezia, thrombocytopenia, and platelet refractory one week after vaccination. On 11/4/02 at 8pm. Bone marrow aspiration and biopsy were performed. The pt was reportedly hospitalized. It was not reported whether the pt recovered.  Reported on 03/04/2003: From follow-up #1 correspondence received on 02/26/2003 it was reported that the patient was hospitalized for 14 days.  Bone marrow results provided - normal marrow elements; abundant megakaryocytes.  The patient reportedly recovered from this experience.  This case is closed.			Y	Y	Y				U	10/27/2002	11/04/2002	8	Bone marrow aspiration and biopsy were performed (no results provided)  F/u #1: (02/26/2003): Normal marrow elements: abundant megakaryocytes.	PVT	OTH	NONE	NONE	Hypercholesterolemia, coronary artery disease and squamous cell carcinoma of the right eye.		U200200974	1						1	Haematochezia; Platelet disorder; Thrombocytopenia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0193068	11/13/2002	FL	72.0			F	11/13/2002	Information has been received from a registered nurse concerning a 72 year old female patient with multiple allergies who on 10/10/02 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent (lot # 643249/0358M). Concomitant vaccination included a dose of influenza virus vaccine in the right arm. Post vaccination the patient developed redness, swelling of her left arm, swelling of her cheeks and swelling of her eyes. On 10/12/02 the swelling increased and the patient developed shortness of breath. The patient was treated with a methylprednisolone sodium succinate benzyl alcohol pack and diphenhydramine HCl. Upon internal review, shortness of breath was determined to be an other important medical event. Additional information has been requested. The follow up states on 10/28/02 the pt had a follow-up visit and the physician documented that she had recovered from her reaction to the pneumococcal vaccine 23 polyvalent. Additional info is not expected.				Y					Y	10/10/2002	10/10/2002	0	UNK	OTH	OTH			Multiple allergies		WAES0210USA02303	1						1	Dyspnoea; Eyelid oedema; Injection site erythema; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0358M~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193088	11/13/2002	PA	64.0	64		F	11/06/2002	Febrile reaction, hospitalized for 2 days after receiving vaccine. Patient discharged with no limitations after 3 days. Highest temperature 104 degrees F.					Y	3			Y	10/16/2002	10/18/2002	2		PUB	PVT		None				1						1	Pyrexia	FLU3~SANOFI PASTEUR~U0908AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0193089	11/13/2002	OR	55.0	54		F	10/16/2002	Patient had immediate swelling of right arm directly after injection into deltoid. Benadryl given in left deltoid 25mg. Patient observed/vitals taken after 15 minutes. 45 minutes after injection, patient had difficulty breathing. Epi .3ml given SC. Patient continued to be monitored. EMS called. EMS arrived; patient transported to hospital. Follow up - Patient was admitted after presumed heart attack. Released one day later. She was then referred to a cardiologist who did an angiogram of her heart. patient released after procedure and home recovering. She will be back to work in 1 week. Slight memory loss noted as well as weakness. 60 day follow up states pt has recovered. The discharge summary states anaphylactic reaction, chest discomfort, and lab test abnormality. Follow-up with clinet 10/30/03. She has completely recovered from heart attack & anaphylactic symptoms post flu shot 1 year ago. Cardiologist did enzyme test & angiogram post heart attact to verify positively that she had one. Ultrasound test done 1 month post heart was done- She hasn't experienced any cardiac symptoms since. No restricitions on activities - Doctor felt incident was contradicition to future flu vaccination.				Y	Y	1			Y	10/16/2002	10/16/2002	0		PUB	PVT	None	None	PCN, Mastoiditis		OR200240	1						1	Amnesia; Anaphylactic reaction; Chest discomfort; Dyspnoea; Laboratory test abnormal	FLU3~EVANS VACCINES~E33352GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0193090	11/13/2002	TX		7		M	11/04/2002	Arm was swollen.									Y	11/04/2002	11/05/2002	1		PVT	PUB		None				1						1	Swelling	FLU3~EVANS VACCINES~E35502KA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0165M~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193091	11/13/2002	TN	66.0	65		F	11/01/2002	Patient in clinic 10/10/02 at 12:57 PM Thursday. Next day, began swelling/hardness and red at site. Also tenderness and pain at site. 10/21/02-Patient states is better but still swelled at site some. Has been very uncomfortable. Went to ER 10/11/02. Has appointment with doctor 10/22/02.				Y					Y	10/10/2002	10/11/2002	1	None	PUB	PUB		None	None	Reaction Uneval~Tetanus Toxoid (no brand name)~~0.00~In Patient	TN02040	1						1	Injection site erythema; Injection site induration; Injection site swelling; Tenderness	FLU3~SANOFI PASTEUR~U0925AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1026m~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193092	11/13/2002	TN	46.0	46		F	10/23/2002	Approximately 10 minutes after vaccination, nose started itching, chest tightness, and dizzy; used inhaler. Nurse administered Epi.; did not improve. EMS arrived and transported to ER. Arrived at ER at 11 AM.				Y					Y	10/22/2002	10/22/2002	0		OTH	UNK	Albuterol, Flovent, Singulaire, Synthroid, Premarin, Lipitor, Diazepam, Paxil, Asthma medication	None	Allergy to aspirin		TN02037	1						1	Chest discomfort; Dizziness; Pruritus	FLU3~SANOFI PASTEUR~U0945AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193093	11/13/2002	TN	45.0	45		F	10/23/2002	Immediately after shot, felt chest tightness, and the resolved immediately. Approximately 2 hours post vaccination, hands started burning, itching and redness appears. Spread to face and arms. Complained of chest tightness. Epi pen administered--improved after 15 minutes. Symptoms returned 15 minutes later. 2nd Epi administered; improved. Returned 10 minutes later. Benadryl 50mg PO given. EMS arrived and transported.				Y					Y	10/22/2002	10/22/2002	0		OTH	OTH	Trileptel; Zanaflex, Zyrtec; Vitamins B12, E, C, B6	None	Allergy to tetracycline		TN02036	1						1	Chest discomfort; Erythema; Pruritus; Skin burning sensation	FLU3~SANOFI PASTEUR~U0945AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193094	11/13/2002	TN	75.0	75		F	10/10/2002	Received flu vaccine IM LD and Pneumonia vaccine IM LD on 10/7/02 per LPN. Patient returned to clinic on 10/9/02. 4 band, swelling, erythema, tenderness left arm. Well demarcated. Reported pain, no rash, left breast and left buttock. Called on 10/10/02 and reported resolved after Benadryl.									Y	10/07/2002	10/08/2002	1		PUB	PUB		none			TN02035	1						1	Injection site erythema; Injection site swelling; Pain; Tenderness	FLU3~SANOFI PASTEUR~U0882AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~996L~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193095	11/13/2002	NC	30.0	29		F	11/04/2002	Symptoms began as achiness then progressed to muscle cramps, then weakness, especially in extremities; fatigue. Symptoms worsened and peaked on 10/30/02. 10/31/02 symptoms began to dissipate. Treatment involved Ibuprofen QID, Braxin, Tylenol.				Y					U	10/15/2002	10/17/2002	2	CK; Rheumatoid Arthritis factor, ESR, TSH, Mono	PVT	PVT	Toporol, Diovan, HCTZ	None	Hypertension, Murmur			1						1	Asthenia; Fatigue; Muscle spasms; Pain	FLU3~EVANS VACCINES~E30112GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0193096	11/13/2002	MI	66.0	66		F	11/04/2002	Patient complained of immediate pain in deltoid muscle after injection. Ongoing discomfort in left arm. Here for evaluation 1 month later.									U	10/04/2002	10/04/2002	0	None	PVT	PUB		None				1						1	Discomfort; Injection site pain	FLU3~SANOFI PASTEUR~U0927AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193097	11/13/2002	NJ	29.0	29		F	10/19/2002	Pruritis, edema, shortness of breath				Y					Y	10/19/2002	10/19/2002	0		MIL	MIL		None	None			1						1	Dyspnoea; Oedema; Pruritus	FLU3~SANOFI PASTEUR~U0983AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193098	11/13/2002	MO	20.0	19		M	11/01/2002	2 hours after injection, patient experienced reduced sensation in lower arm with reduced ?. Injection area was edematous with redness and heat.				Y					Y	10/24/2002	10/24/2002	0	None	PVT	PVT	None	None	Allergy to Penicillin			1						1	Feeling hot; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U0886AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193099	11/13/2002	MD	61.0	61		F	11/04/2002	Complaints of left arm pain, redness and swelling to immediate care center 11/02/02. Treatment with Allegra and antibiotic.				Y					Y	11/01/2002	11/02/2002	1	None	PUB	PUB	Insulin	None	Diabetic			1						1	Erythema; Injection site swelling; Pain	FLU3~PFIZER\WYETH~4020026~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1051L~2~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193100	11/13/2002	MD	57.0	57		F	11/04/2002	Woke up 10/31 with severe pain in left arm, upon movement. 11/1/02 Reddened, warm to touch with continued pain and swollen. To PMD 11/1/02; Placed on antibiotic and Clarinex.				Y					Y	10/30/2002	10/31/2002	1		PUB	PUB	Lopressor, Atarax	None	HBP, Hx of cellulitis, Allergy to sulfa; Environmental allergies			1						1	Feeling hot; Injection site erythema; Injection site swelling; Pain	FLU3~PFIZER\WYETH~4020026~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1051L~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193101	11/13/2002	VA	75.0	75		F	12/27/2002	2 hours after immunizations, right arm became very sore. During the night, cold sweats. Next day right arm swollen, erythematous shoulder to elbow. Day 2, a little less edematous/erythematous. Denies numbness and itchiness.									Y	11/05/2002	11/05/2002	0		PUB	PVT		NONE	NONE			1						1	Hyperhidrosis; Injection site erythema; Injection site oedema; Injection site swelling	FLU3~PFIZER\WYETH~4020029~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0111M~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193102	11/13/2002	PA		61		F	11/07/2002	Received vaccine 10/31/02. Wakened with nausea/vomiting 4AM 11/01/02; gone by 8AM 11/01/02. Chills, headache, upper body aches remainder of 11/01/02. Woke on 11/2/02 completely recovered.									Y	10/31/2002	11/01/2002	1		OTH	OTH	Actonel, Synthroid, Altace, Rilafen		Osteopenia, HBP, Arthritis, Hypothyroid			1						1	Chills; Headache; Nausea; Pain; Vomiting	FLU3~EVANS VACCINES~E37182KA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0193103	11/13/2002	GA	37.0	37		F	11/06/2002	Left arm sore; can move it.										11/06/2002	11/06/2002	0		OTH	UNK						1						1	Pain	FLU3~SANOFI PASTEUR~0922AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193104	11/13/2002	OH	59.0	59		F	11/08/2002	Pneumoccal vaccine given 11/06/2002. Within 5 mins site at right deltoid- throbbed, continued to hur that day. Arm swelled by that evening, 9-10 hours later, decrease pain and swelling on Thursday. Area of arm near elbow, front and back- red, warm, entire arm painful. Went to MD 11/08/2002				Y					U	11/06/2002	11/06/2002	0	TB Mantoux C0833AA Lt Fa	PUB	PVT	Prevacid, Detrol, Macrobid, Le dose Antibiotic per QD	NONE	Hypertension			1						1	Feeling hot; Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U0925AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0165M~2~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193105	11/13/2002	OH	31.0	31		F	11/04/2002	Pt began experiencing nausea and felt as though she was going to pass out. She experienced slight light headache and dizziness. Symptoms began apprx. 2 hours after vaccination and lasted about one hour.									Y	10/31/2002	10/31/2002	0		PVT	PVT	NONE	NONE	NONE			1						1	Dizziness; Headache; Nausea	FLU3~SANOFI PASTEUR~U09040A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193106	11/13/2002	OH	43.0	43		F	11/04/2002	Approximately 45 mins-1hr, she became lightheaded and dizzy. She also reported a sore throat. The day after she reported a temperature of 101 deg F and body ache. Said she spent most of the weekend in bed. 11/4 reported L ear pain, chest tightness, runny nose.									U	10/31/2002	10/31/2002	0		PVT	PVT		NONE	Allergies to cats, dogs, trees, grass, weeds			1						1	Chest discomfort; Dizziness; Ear pain; Pain; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~U0904DA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193107	11/13/2002	OH	39.0	39		F	11/04/2002	Within 45 mins of receiving Fluzone lot #U09040A exp 6/30/03. Pt became lightheaded, dizzy, experienced body aches and alternted between hot and cold. She described her face as feeling pluckly (like it was asleep). her symptoms resolved in the evening.									Y	10/31/2002	10/31/2002	0		PVT	PVT	NONE	NONE	MVP, hypoglycoma			1						1	Dizziness; Facial palsy; Pain	FLU3~SANOFI PASTEUR~U09040A~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193108	11/13/2002	NE	7.0	7		M	11/04/2002	Severe induration, weeping, has puritic rash, swelling shoulder - elbow.									U	10/29/2002	10/30/2002	1		PVT	PVT	Atenolol	NONE	Marfans			1						1	Crying; Injection site induration; Oedema; Rash pruritic	FLU3~SANOFI PASTEUR~U0950AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193109	11/13/2002	KS	47.0	47		F	11/04/2002	Itching noted @ site with injection given lasting 1-2 mins 10-15 min post injection, Felt left side tongue go numb lasting approx 10 minutes. 24 hours post injection - is soaking in hot bathtub, Noted local reaction-very large , red, raised warm to touch,but no pain. lasted till 11/04/02 -now appears slightly raised and bruised.									Y	11/01/2002	11/02/2002	1	N/A	PVT	PVT	Prozac, Herbal supplements,Vitamin supplements,A llegra, Mircatte, Nexium	NONE	Allergic to PCN, boric acid & betadine	Local reaction~Tetanus Toxoid (no brand name)~~15.00~In Patient		1						1	Contusion; Hypoaesthesia; Injection site reaction; Injection site warmth; Pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~UO888AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193110	11/13/2002	OH	44.0	44		F	11/04/2002	Sore joints in upper arm. Patient also works in meat/deli department. Lifts and slices meats so also wondered if from this. Site looks fine.				Y					U	10/25/2002	10/25/2002	0	None	OTH	UNK						1						1	Arthralgia	FLU3~SANOFI PASTEUR~U0922AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193111	11/13/2002	KY	62.0	62		M	11/07/2002	11/04/2002 at 07:15 am received flu vaccine. 11:30 am felt hot and had tenderness in sinus area. 07:00pm had nausea, abdominal cramping and diarrhea. On 11/05/2002 called MD, pt advised to take Tylenol and increase water.									Y	11/04/2002	11/04/2002	0	NONE	UNK	OTH	Nexium, Fiber-Con, Temolol, Multi-Vit	NONE	Glaucoma, Osteo arthritis COPD			1						1	Abdominal pain; Diarrhoea; Injection site warmth; Nausea; Tenderness	FLU3~EVANS VACCINES~E31882GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0193112	11/13/2002	CA	65.0	65		F	11/05/2002	Swelling elbow to neck right; pain; fever; skin hot to touch.									U	11/04/2002	11/04/2002	0	CBC	PVT	PUB	None	None	Hyperthyroid			1						1	Feeling hot; Pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U0885AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0872M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193115	11/13/2002	NY	60.0	60		M	11/07/2002	Left elbow redness, swelling from just above left elbow into mid forearm, warm to touch. Levaquin 500MG PO QD for 7 days.				Y					U	11/06/2002	11/07/2002	1	CBC normal; no elevated WBC; Because of unrelated fall, X-ray left elbow negative.	PUB	OTH		None	PCN< NIDDM, Elevated cholesterol, asthma			1						1	Feeling hot; Injection site erythema; Injection site swelling; Cellulitis; Oedema; Pain	FLU3~EVANS VACCINES~E33402HA~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0541M~UNK~~LA~PNEUMO (PNEUMOVAX)~1|FLU3~EVANS VACCINES~E33402HA~6~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~0541M~1~SC~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0193116	11/13/2002	IN	79.0	79		F	11/07/2002	Heat, pain and redness to affected site of left upper arm.									Y	11/04/2002	11/04/2002	0	None	PVT	PVT						1						1	Feeling hot; Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U0924DA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1160L~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193117	11/13/2002	MS	68.0	68		M	11/04/2002	Redness and swelling right arm from elbow to shoulder area. Painful to touch. To ER at 9:30pm 10/30/2002. No Tx. To MD 10/31/2002. Diphenhydramine prescribed. Allergic reaction diagnosed. 11/04/2002 phone call from client. He cancelled flu appt for  Seen by MD 11/01/2002- today 11/04/2002. He stated mu arm is better today, no swelling or pain.				Y					Y	10/30/2002	10/30/2002	0		PUB	PUB		NONE	Hypertension		MS02032	1						1	Hypersensitivity; Injection site erythema; Injection site oedema; Pain	FLU3~PFIZER\WYETH~4020030~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0445M~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193118	11/13/2002	OR	81.0	81		M		Approximately 14 hours after immunization, patient woke up with nausea, vomiting, diarrhea, anorexia, and increased fatigue. Symptoms lasted for 7 days.									Y	10/28/2002	10/30/2002	2	None	PVT	PVT	Unk	Unk	Unk			1						1	Anorexia; Diarrhoea; Fatigue; Nausea; Vomiting	FLU3~PFIZER\WYETH~4020020~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0193119	11/13/2002	WA	46.0	46		F	11/07/2002	Area has localized erythema, discomfort, and itching in shoulder; arm and neck aching.										11/05/2002	11/06/2002	1		PUB	PUB		None	PCN, Sulfa			1						1	Discomfort; Injection site erythema; Pain; Pruritus	FLU3~SANOFI PASTEUR~U0951AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193120	11/13/2002	WI	30.0	30		F		Redness, swelling of arm extending down into left elbow & lower arms, difficulty using  left arm and discomfort				Y					Y	10/30/2002	10/30/2002	0	NONE	UNK	OTH	NONE	NONE				1						1	Discomfort; Injection site erythema; Injection site swelling; Joint range of motion decreased	FLU3~SANOFI PASTEUR~UO958AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193121	11/13/2002	WI	58.0	58		F	11/06/2002	Apprx. 1 month following vaccine- thighs, upper arms, lower buttocks hurt. Comes and goes.									N	11/13/2001	01/01/2002	49	UA-nl, CPK. ESR.AIK PNOS, TSH, CBC, FT4, RA, GLU CA - ANK, Cat Scan, Lumbar spine-neg, Pelvis- neg, Bone scan- neg	PVT	PVT	Euista		Allergic to Sulfa/Dx Osteoarthritis, Raynauds, Minimal Arthritis			1						1	Pain	FLU3~SANOFI PASTEUR~U0683BA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193122	11/13/2002	LA	56.0	56		F	11/04/2002	Vaccine given 10/30/02. Now some itching, rash (urticaria) on 11/2/02.									U	10/30/2002	11/02/2002	3		PVT	UNK	Premarin, Zucor	None	None			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0937AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0710M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193178	11/13/2002	WA	69.0	69		F	10/31/2002	Pt received Pneumo shot on 10/29/02. Slowly developed redness at injection site, tender also developed fever, lightheaded and syncope for less than minute yesterday (husband witness). Pt was also given flu-shot same day on other arm.									N	10/29/2002				PVT	UNK						1						1	Dizziness; Injection site erythema; Injection site pain; Pyrexia; Syncope	FLUX~UNKNOWN MANUFACTURER~4020019~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0445M~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193189	11/13/2002	PA	81.0	81		F	11/11/2002	Right deltoid (site of injection) swelled and became erythematous starting about 12 hours after injection. Patient then developed fever, N/V, dehydration, confusion--was admitted. The discharge summary states local reaction to pneum. vaccine.					Y	3			Y	11/06/2002	11/06/2002	0	Blood and urine cultures negative; CXR negative	PVT	PVT		NONE	Asthma, hypertension, GERD			1						1	Confusional state; Dehydration; Injection site erythema; Injection site swelling; Pyrexia	FLU3~EVANS VACCINES~E31952GA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0376M~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0193191	11/13/2002	NY				F	11/13/2002	Rash slightly remaining. Slight swollen and sensitive to touch.									U	11/12/2002	11/12/2002	0		UNK	UNK						1						1	Oedema; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0193192	11/13/2002	CO	44.0	44		F	11/11/2002	Migratory monoarthritis.				Y					U	11/07/2002	11/08/2002	1	B and P; WESR-70	PVT	PVT	Lipitor, Prolomax, Prolamarin	NONE	Tetracychon, sulfa, GERD, hyperlipidemia			1						1	Arthritis	FLU3~SANOFI PASTEUR~U0875AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193193	11/13/2002	VA	46.0	46		F	11/12/2002	Approx 2 hrs after receiving flu vaccine pt presented c/o hot flashes, flashing and generally not feeling well. BP 164/110, P 102 reg R 20 unlabored. Skin of face and legs red and very warm to touch. No facial swelling or dyponia. Advised to go to ER across the street. Seen treated sent home ER.				Y					U	11/12/2002	11/12/2002	0		OTH	PUB	Lopid, Allegra D	NONE	Sulfa drugs, pcn			1						1	Erythema; Feeling hot; Hot flush; Malaise	FLU3~SANOFI PASTEUR~U0913AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193194	11/13/2002	TX	73.0	73		F	10/08/2002	Pt developed erythema (6cm x 6cm) and mild induration at site of influenza vaccine over a time course of 24 hrs. No respiratory symptoms. Pt treated with oral Prednisone x 2 days and steroid, given oral antihistamine x 3 days.									Y	11/04/2002	11/05/2002	1	NONE	PVT	UNK		NONE	COPD, breast cancer, allergy to tetanus			1						1	Injection site erythema; Injection site induration	FLU3~EVANS VACCINES~E3573HA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0193197	11/13/2002	FL	68.0	68		F	11/13/2002	itching rash on arms and neck, began morning after pneumonia and flu shot									Y	11/07/2002	11/08/2002	1		UNK	UNK	Lisinopril, Calan, Tricor	none	HTN, elevated triglyceride			1						1	Rash pruritic	FLU3~SANOFI PASTEUR~U0945AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0675M~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193198	11/13/2002	MD	49.0	49		M	11/13/2002	Administered Fluzone vaccine to patient around 2:30 pm on 11/12/02.  Patient left health unit and returned to office.  Approximately 30 minutes later, a co-worker of the patient entered health unit and stated I think one of my co-workers is having a seizure.  Entered patient's office around 3 pm and found him sitting in his chair, A&Ox3.  No apparent seizure activity.  Answered all questions appropriately.  +PEARRL.  Gait steady.  MAE x4.  BP 136/96, HR 80's.  States he had taken his medication as usual today (for seizure disorder).  Also states he believes he did have a seizure prior to my arrival.  Co-workers state there was no physical activity, but a change in LOC and orientation.  No seizure activity noted by nurse upon arrival.  No treatment needed.  Discussed possible relation between flu vaccine and seizure with patient.  Unable to determine if there is a correlation.									Y	11/12/2002	11/12/2002	0	None.	PUB	PUB	Currently taking Tegretol and Keppra.	none	Seizure disorder; arthritis.			1						1	Convulsion	FLU3~SANOFI PASTEUR~UO959AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193199	11/13/2002	VA	50.0	50		M	11/13/2002	Starting Nov 8, experience severe sore throat, low grade fever, terrible cough, and stuffy nose. Very tired and in bed 5 days. Saw physician on Nov 9.				Y					Y	11/06/2002	11/08/2002	2		PUB	PVT		No fever or acute illness	None			1						1	Cough; Nasal congestion; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U0881AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193200	11/13/2002	DC	28.0	28		M	11/13/2002	Fever,achiness,stomach upset and headache.Recovered about 5 days									Y	10/29/2002	10/29/2002	0		PUB	PVT		No fever or other acute ilness	None			1						1	Headache; Pain; Pyrexia; Stomach discomfort	FLU3~SANOFI PASTEUR~U0881AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193204	11/13/2002	NH	71.0	71		M	11/13/2002	Site of injection swollen to size of half an orange, painful R deltoid.									U	11/11/2002	11/11/2002	0	NONE	PVT	PVT	Combivent, Zamacort, vit. E, multivitamin, Aspirin	NONE	Penicillin allergy, COPD, hyperlipidemia, gout, arthritis			1						1	Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4020004~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1387L~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193205	11/13/2002	GA	72.0	71		F	11/13/2002	Flu vaccine administered 10/11/02. 10/13/02 developed brown discoloration. Slightly red injection site and swollen.									Y	10/11/2002	10/13/2002	2		PVT	PUB			ASN, DM, DJD, lipedimis			1						1	Injection site erythema; Injection site oedema; Skin discolouration	FLU3~SANOFI PASTEUR~V0908AN~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193281	11/13/2002	OH	49.0	49		F	11/13/2002	I was dizzy about five minutes after the shot, and the dizzyness increased through the day.  When active or eating, the dizzyness went away a little.  When I went to bed at night, as I began to relax more, the room began to spin.  I could not take my medication - Prilosec - before I ate in the evening, because I was afraid that it would make me more dizzy.  I could not drive in the evening.  Also, the pain I suffer in the rest of my abdomen from chronic endometriosis increased greatly.  My abdomen swelled, making my clothing tight at the waist.  This was not because I had skipped taking the Prilosec, because this occured in a different part of the abdomen.  Due to recent endometriosis symptoms (prior to this vaccine), I have been eating less, and my clothing has been loose at the waist, before yesterday.  Even though endometriosis is a condition that I usually must deal with, I need to know just how vaccinations affect it.  I had the flu last spring, and my internist had strongly suggested that I get a flu shot this year, but I am not sure if my endometriosis will increase.  I also suffer from chronic excema problems, but today, my entire face is red and itchy, much more than usual.  I am less dizzy today.  However, my abdomen is still more swollen than usual.  I am seeing my gynecologist tomorrow.  I have had no other vaccines recently.  I have had recent abdominal pain, probably due to a return of endometriosis, but adding stress from any source can cause further problems.  Stress increases hormone levels, which increase the growth of endometriosis tissue at locations where it should not be.  Although I am most concerned about the abdominal stress, I am also concerned about the dizzyness, and I do not know the source of that.									U	11/12/2002	11/12/2002	0	I was not tested for anything related to this flu shot.	UNK	UNK	Prilosec	endometriosis, slight asthma	endometriosis (diagnosed by laparoscopy) slight asthma (diagnosed by a respiratory therapist)			1						1	Condition aggravated; Dizziness; Erythema; Oedema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0191715	11/14/2002	IN	50.0	50		M	12/10/2002	Information has been received from a registered nurse concerning a 50 year old white male who on 10/02/02 was vaccinated IM in the left deltoid with the first dose of pneumococcal vaccine 23 polyvalent. On 10/3/02, the pt was vaccinated IM in the left deltoid with a dose of concomitant suspect therapy influenza virus vaccine (Fluzone), which was last administered in 2001. On 10/3/02, the pt's arm became extremely swollen and painful. The registered nurse reported that the pt was instructed to seek medical attention. The pt was treated with Augmentin, Tylenol and moist heat. The pt continued to be in pain and became very weak. The pt was admitted to the hospital for three days (dates not reported), and was treated with IV antibiotics. The registered nurse reported that the pt was home and recovering. *In follow-up, the registered nurse reported that the PT had recovered from the experience.* No further info is expected. A 15-day follow up report received 7/15/2003 adds: The pt was admitted to the hospital for 3 days (dates not reported) and was treated with IV antibiotics. The registered nurse reported that the pt was home and recovering. In folow-up the registered nurse reported that the pt had recovered from the experience. It was noted that the pt and the pt's sibling had no adverse events following prior vaccination. The case is closed, no additional info is anticipated. This is an amended report. The adverse event onset date and time (10/02/2002 at 4:00 PM) have been updated and the date and time of administration of secondary suspect vaccination (10/02/2002 at 4:00 PM) has been updated. This is a corrected report, as amended.				Y	Y	3			Y	10/02/2002	10/02/2002	0		PUB	PVT			UNK		WAES0211USA00612	1						2	Pain; Swelling; Injection site oedema; Injection site pain; Muscular weakness	FLU3~SANOFI PASTEUR~U0911AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~1160L~1~IM~LA~PNEUMO (PNU-IMUNE)~1|PPV~MERCK & CO. INC.~1160L~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0193012	11/14/2002	CA	47.0	47		M	11/04/2002	Mon 10/21/02 9:15am IM flu vaccine. 10am headache. 10:30am nausea, dizziness. 1:00 fatigue. 1:00-6 at work at home exhausted passed out at home under three blankets, sweating, up, down from bed to urinate slept till 7am Tue 10/22/02.									U	10/21/2002	10/21/2002	0	NONE	PUB	UNK		NONE	Bi-polar no med's			1						2	Asthenia; Dizziness; Fatigue; Headache; Loss of consciousness; Subcutaneous nodule; Dizziness; Fatigue; Headache; Hyperhidrosis; Loss of consciousness; Nausea; Pollakiuria	FLU3~EVANS VACCINES~E35722HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|UNK~UNKNOWN MANUFACTURER~~UNK~~~VACCINE NOT SPECIFIED (NO BRAND NAME)~2	USA		Influenza
0193216	11/14/2002	CO	76.0	75		M		Two weeks after flu-pneumonia shots I got flu like symptoms and skin rash. Gradually the rash on my legs turns in vasulitis and foot drop. In December of last year I contracted unusual and extremely severe skin rash and flu like symptoms, just two weeks after my flu-pneumonia shots. One week later, I got typical flu like symptoms, with joint pain, fevers with temperatures over a 100 deg. F. This condition went on for five weeks. I spent five days in a local hospital. I was treated with antibiotic Augmentum and eventually my temperatures came down to normal by 1/20. However, the rash which started before the flu gradually spread all over my body. It was of very unusual character, extremely irritating burning and itching to a point where I was not able to sleep. Eventually the rash spread all over my body. The dermatologist ordered a biopsy, which was done and came back negative, so no pathogen was found responsible and that condition was diagnosed as eczema. A variety of cortisone ointments were prescribed with little or no healing effect. In early February, I noticed swelling on my ankles and some strange pinching sensation when I pressed with my finger the soft tissue. MD, who was subtitling for my primer physician did not make any conclusion and simply said it is common for older people. Later the same month, I again went to see my primer physician MD and I was started on ointments Triamcinolone Acenonide cream 0.025%. This was the first cream which started to reduce the rash and itching. However, the rash persisted to stay on both legs. Under the skin patches of very painful strips developed along the tibia bone. In late May 2002 this condition worsened even more and then started a pinching and stabbing sensation. Also both legs and ankles got more swollen and the swelling gradually has spread further up to the knee. The reddish spots were inflamed and sensitive to touch and it started to appear around the front leg bone and some dark blue spots occurred on the right leg. This condition was getting worse and w...The medical records state thrombophilebitis, and edema of leg.			Y	Y	Y	6		Y	N	11/20/2001	12/07/2001	17	Biopsy of sural nerve	PVT	UNK		Bronchyestacy, MDS Syndrome	Poor appetite, weight loss, Hypothyroid-BPH			1						1	Arthralgia; Asthenia; Eczema; Hypoaesthesia; Influenza like illness; Marrow hyperplasia; Oedema; Oedema peripheral; Pain; Paralysis; Peroneal nerve palsy; Pruritus; Pyrexia; Rash; Sleep disorder; Thrombophlebitis; Vasculitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0945K~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0193222	11/14/2002	MI	66.0	66		F	11/07/2002	Apprx. 6 inches below and forward of inject site is sore, swollen, hot , hard and discolored are apprx. 3 in long x 1 in wide. Afebrile. Hx Slint (rt coronary artery) 11/2/2000. Treated 10/09/2002 for abcessed tooth and subsequently 3 courses of antibiotics due to degree of infection.									Y	11/05/2002	11/05/2002	0		PVT	PVT		RECOVERING FROM ABCESSED TOOTH	RT CORONARY ARTERY SLINT ON 11/02/2000			1						1	Injection site induration; Injection site oedema; Injection site warmth; Pyrexia; Skin discolouration	FLU3~EVANS VACCINES~E33402HA exp 06~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0193223	11/14/2002	OH	72.0	72		M	10/30/2002	10/24/02 Felt tired with aches in PM following exercise (swimming). 10/25/02 Right arm with swelling and redness extending from site to wlbow on outer arm in 3 width; fever 101. 10/26/02 Redness worsened, site warm; fever down; felt better. 10/28/02 Still some redness, less swelling. 10/29/02 Some redness but no swelling.									Y	10/23/2002	11/24/2002	32	None	OTH	PVT		None				1						1	Fatigue; Feeling hot; Injection site erythema; Injection site swelling; Pain; Pyrexia	FLU3~EVANS VACCINES~E31882GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1449K~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193224	11/14/2002	MO	46.0	46		M		Severe shakes & chills, Sore throat, Mild headache, Severe backache - To bed									Y	11/06/2002	11/06/2002	0	NONE	PUB	PVT	NONE	NONE	Back problem 4 years ago			1						1	Back pain; Chills; Headache; Pharyngolaryngeal pain; Tremor	FLU3~SANOFI PASTEUR~UO446AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193225	11/14/2002	CA	42.0	42		F	11/01/2002	Patient has 17.5cm long by 9cm high induration with erythema to right lower deltoid/upper arm. Area tender to palpitation. Right shoulder with reduced range of motion. Malaise/Myalgia.									U	10/30/2002	10/30/2002	0	PPD	PVT	PUB	None	None	Hypercholesterolemia			1						1	Injection site erythema; Injection site induration; Joint range of motion decreased; Malaise; Myalgia; Tenderness	FLU3~SANOFI PASTEUR~U0933AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1159L~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U0530AA~4~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0193226	11/14/2002	WI	38.0	38		F	11/07/2002	Developed large red, raised wamr to touch area were shot was given, approximately 6cm by 5-7cm. Area was sore, employee able to use arm, no hives, rashes or other problem. Area resloved within couple of days. No residual problem.									Y	10/28/2002	10/29/2002	1		OTH	OTH	UNK	NONE	NONE			1						1	Feeling hot; Injection site erythema	FLU3~EVANS VACCINES~E33092HA~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0193228	11/14/2002	ID	62.0	62		F	11/05/2002	11-4-02 Lili complained of tenderness under the arm by armpit and breast area. I sent her to urgent care to be examined. She came back with a keflex prescription for infection, which she later decided not to take because she had an allergic reaction to the Rocephin. Shot in the E.R. The keflex was swtiched to Augmentin				Y					U	11/02/2002	11/04/2002	2		OTH	UNK	Prempro 2.5					1						1	Tenderness	FLU3~SANOFI PASTEUR~U0922AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0675M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193229	11/14/2002	CA	50.0	50		F	11/04/2002	Very high fever, nausea, pounding and rapid heart rate, intense headache, inability to sleep. My arm became swollen, red and sore over an area about the size of my hand. I became very upset when my husband went out to take care of our dogs and didn't come right back. I imagined he had died, and I cried uncontrollably.									Y	11/01/2002	11/01/2002	0		PVT	UNK	Toprol XL, Digoxin, Dyazide, Potassium, Coumadin, Triestrogen, Testosterone, Clonazepam, Vitamin D, Magnesium, Multi-vitamin	None	Congestive heart failure, Artificial Mitral Valve	Flu-like symptoms~Influenza (Seasonal) (no brand name)~~48.00~In Patient		1						1	Erythema; Headache; Heart rate increased; Nausea; Pain; Pyrexia; Sleep disorder; Swelling	FLU3~SANOFI PASTEUR~U0883AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0735M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193230	11/14/2002	SC	56.0	57		F	11/08/2002	Right arm deltoid swollen & red, Meds given				Y					N	11/01/2002	11/08/2002	7	NONE	PVT	OTH	Veropamil, Lescol XL, HCTZ	NONE	NKA			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~UO891AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193231	11/14/2002	NY	72.0	73		F	10/25/2002	Flu administered 10/22/02. On 10/24/02 patient woke up with a sore left arm, very red.									Y	10/22/2002	10/24/2002	2	Cellulitis of left arm	PVT	PVT	Altace 2.5mg Lipitor Albuterol	NONE	CAD, high cholesterol			1						1	Cellulitis; Erythema; Myalgia	FLU3~SANOFI PASTEUR~V0910AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193232	11/14/2002	OK	57.0	57		F	11/05/2002	Rash all over body. Still have it, First noticed 11/05/02 5:30 am, Using hydrocortisone cream.									Y	10/30/2002	11/05/2002	6	NA	OTH	OTH	NONE	NONE	NKA			1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193233	11/14/2002	IN	25.0	25		F	11/06/2002	8 cm radius induration - tender, red				Y					Y	10/30/2002	11/01/2002	2	NONE	PVT	PVT	NONE	NONE	NKA			1						1	Injection site erythema; Injection site induration; Injection site pain	FLU3~SANOFI PASTEUR~UO955AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193234	11/14/2002	NY	36.0	36		F	11/05/2002	Pain in left deltoid with radiation to neck, throbbing.									N	10/28/2002			NONE	UNK	UNK		NONE				1						1	Pain	FLU3~SANOFI PASTEUR~U0934AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193235	11/14/2002	WI	50.0	50		F	11/04/2002	Got the chills very bad, Lasted from about 4:00 PM threw (sic) the night. Couldn't get warm, Shook all night, My bones hurt and muscles. The next day, I was very tired and slept most of the day. The next day, I was very weak and couldn't do much without having to lay back down. I was unable to do much for 2 days.									Y	10/23/2002	10/23/2002	0		PUB	PVT		NONE				1						1	Asthenia; Chills; Tremor	FLU3~SANOFI PASTEUR~UO954AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193236	11/14/2002	CA	48.0	48		F	10/31/2002	Left upper arm swollen due to flu shot.									Y	10/22/2002	10/22/2002	0	NONE	PVT	OTH		NONE				1						1	Swelling	FLU3~SANOFI PASTEUR~~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193237	11/14/2002	OH	73.0	73		M	11/06/2002	Shot administered at 13:30 PM Saturday 11/2/2002. Chills and fever at 02:00 Sunday. Patient noticed severe rash and elbow/shoulder swelling in arm. Fever 102. Forearm still tender. Grip strenth poor still.									Y	11/02/2002	11/03/2002	1	None	PUB	PUB	Various					1						1	Chills; Pyrexia; Rash; Swelling; Tenderness	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0820N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193238	11/14/2002	MO	32.0	32		F	11/06/2002	Localized reaction approximately 5cm circumference. Hot to touch. Client state is allergic to latex(could possibly be allergic reaction from that)									U	11/05/2002	11/06/2002	1		PUB	UNK		NONE				1						1	Injection site warmth	FLU3~PFIZER\WYETH~4020027~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0193239	11/14/2002	FL	72.0	72		M	10/31/2002	Low grade fever, Malaise, Myalgia; TX: Ibuprofen 400mg q 6 hours									Y	10/29/2002	10/30/2002	1	NONE	PVT	OTH	Toprol 50 mg 1/2 qd	NONE	NKDA, Increased Chol, HTN			1						1	Malaise; Myalgia; Pyrexia	FLU3~EVANS VACCINES~E30132FA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0210M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193240	11/14/2002	CA	58.0	58		F	10/30/2002	Left arm 3 below site of injection. 3 red area warm to touch, sore; started 10/28/02 increasing. Complained of body aches, headache, temperature 97.5. Ibuprofen given. Ice pack to arm.										10/28/2002	10/28/2002	0		OTH	OTH		None	PCN, Novacaine	Redness/Achiness left arm~Influenza (Seasonal) (Fluzone)~~57.00~In Patient		1						1	Body temperature decreased; Feeling hot; Headache; Injection site erythema; Pain	FLU3~SANOFI PASTEUR~U0883AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193241	11/14/2002	NM	33.0	33		F	10/21/2002	Within 10-15 minutes of injection, patient became hot and flushed all over. Took benadryl 25mg PO and symptoms subsided.									Y	10/21/2002	10/21/2002	0	None	PVT	PVT	None	None	Niacin			1						1	Hot flush	FLU3~SANOFI PASTEUR~U0905FA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193242	11/14/2002	IA	65.0	65		F	11/01/2002	Given vaccine approximately 03:15PM. About an hour later, I began to feel weak and tired, developed a headache, the muscle aches in neck and body; got very tired and slept most of the next day and a half.									Y	10/20/2002	10/20/2002	0	None	PUB	PVT			Diabetic, Asthmatic			1						1	Asthenia; Fatigue; Headache; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193243	11/14/2002	ND	60.0	60		M	11/04/2002	Injection given 10/11/02, right Arm IM, On 10.12/02 noted swelling & redness around injection site. On 10/13/02, skin was red, Swollen skin stretched, Pt took Benadryl & Bufferine. On 10/13/02, went to ER because the swelling was moving to forearm & down toward wrist. On 1/15/2002, returned to ER and was put on antibiotics. At present, pt is fine with no effect.				Y						10/11/2002	10/12/2002	1	Not known	PUB	PUB	NONE	NONe	NKA			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~UO882AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0526L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193244	11/14/2002	OH	59.0	59		M	11/07/2002	Received flu vacine 8A-215P developed numb lips, swollen lips and tough-scratchy throat-felt like it was closing. Rx ER steroids and antihistamines.				Y					Y	11/06/2002	11/06/2002	0		OTH	PVT		NONE	NKA			1						1	Face oedema; Hypoaesthesia; Throat tightness	FLU3~SANOFI PASTEUR~U0881AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193245	11/14/2002	MO	72.0	72		F	11/06/2002	Patient states lips swollen and tongue numb and legs weakened approximately five minutes after flu vaccine administered. On advice of nurse went to ER given generic pepcid AC and prescribed for pepcid AC. When brand name pepcid AC taken, allergic reaction exacerbated. Went back to ER and give presciption for generic pepcid AC.				Y					N	11/05/2002	11/05/2002	0		PUB	PUB	Inderol 50mg qid, Isoptin SR 240mg O.D.		M.V.P., HPTN, Migraine, multiple allergies to binders in medications			1						1	Hypoaesthesia; Muscular weakness; Swelling face	FLU3~PFIZER\WYETH~4020033~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0193246	11/14/2002	NM		33		F	11/04/2002	Broke out in hives starting on her back then to buttocks and legs. Took Benadryl tabs for next 24 hours.									Y	10/31/2002	10/31/2002	0	None	PVT	PVT	Triazidone, Menest, Baclafen, Soma	None	Migraines	Hives~DTP (no brand name)~~0.00~In Patient		1						1	Urticaria	FLU3~SANOFI PASTEUR~U0905FA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193247	11/14/2002	MD	81.0	81		F	11/05/2002	Cellulitis left arm. Pain and little itching.									Y	10/30/2002	10/30/2002	0		PVT	PVT	Prinivil, Paxil, Ditropan XL	Gall Stones	PCN, Phenobarbital			1						1	Cellulitis; Pain; Pruritus	FLU3~EVANS VACCINES~E32852GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0445M~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193248	11/14/2002	GA	54.0	54		F	11/04/2002	Area on left deltoid approximately (4cm); red and warm, slightly sore to touch.									Y	10/30/2002	11/01/2002	2		PVT	PVT		None	HTN, Mitral regurgitation, No allergies.			1						1	Feeling hot; Injection site erythema; Pain	FLU3~EVANS VACCINES~E34682HA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0193249	11/14/2002	DE	46.0	46		F		Flushing noted by pt -  face,arms, legs, No hives, Vital signs WNL, DX by doctor dermatitis medicamentosus, Given Allegra 60 mgm po,Then this evening & BID if necessary.				Y					Y	10/10/2002	10/10/2002	0	NONE	PVT	OTH		NONE	NKA			1						1	Drug eruption; Flushing	FLU3~SANOFI PASTEUR~UO888AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193250	11/14/2002	WI	40.0	40		F	10/31/2002	Nausea, facial swelling, and neck discomfort 30 minutes after injection. Shortness of breath with treatment in ER 3 hours later.				Y					Y	10/28/2002	10/28/2002	0		OTH	PUB	Levsinex	None	Sulfa			1						1	Dyspnoea; Face oedema; Nausea	FLU3~PFIZER\WYETH~4020027~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0193252	11/14/2002	OH	28.0	28		F	12/23/2002	Swollen, red, and warm. Itching at temperature site. Itching after injection with large red, warm area size of orange at injection site withitching.									Y	11/11/2002	11/12/2002	1		OTH	OTH		NONE				1						1	Feeling hot; Injection site erythema; Injection site hypersensitivity; Injection site swelling; Pruritus	FLU3~EVANS VACCINES~E35812KA~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0193253	11/14/2002	PA	56.0	56		F	11/12/2002	Redness and sore right arm. Chills, shakes, woozy, nerve syncope. Right arm swelled, spackled; episodes of diaphoresis.									Y	11/08/2002	11/09/2002	1		PVT	OTH	HCTZ, Prilosec, Premarin					1						1	Chills; Erythema; Hyperhidrosis; Pain; Somnolence; Swelling; Syncope; Tremor	FLU3~SANOFI PASTEUR~U0988A~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0872M~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193254	11/14/2002	NC	29.0	29		M	10/23/2002	beginning 10/16/2002 6:30 am upon wakening had dizziness Began Bonine that night, Saw Med One MD  for eval, 10/19/02 Continue Bonine, Dx: could be reaction to the vacc or Labrinthitis ,11/22/02 Saw ENT specialist for eval ,RX: Antivert BID, Poss reaction to flu vaccine, Labrunthitis  may last 2-3 or longer				Y					U	10/14/2002	10/16/2002	2		OTH	OTH	NONE	NONE	NKA			1						1	Dizziness; Labyrinthitis	FLU3~SANOFI PASTEUR~UO922AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193255	11/14/2002	VT	40.0	40		F	11/13/2002	24 hours influenza vaccination first time recipient reports itching at site x 3 days.									Y	11/08/2002	11/09/2002	1	NONE	OTH	PVT	NONE	NONE	shellfish allergies			1						1	Injection site hypersensitivity; Pruritus	FLU3~SANOFI PASTEUR~UO951AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193286	11/14/2002	MS	41.0	41		F	11/14/2002	Injection in L arm began to burn after completed night of 11/05/02 pt noted swollen area under arm. Swelling lasted 3-4 days. Treated with hot compress.				Y					Y	11/04/2002	11/04/2002	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Injection site inflammation; Injection site oedema	FLU3~SANOFI PASTEUR~U0903AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193288	11/14/2002	CA	79.0	79		F	11/14/2002	Dizzy spells, nausea and lose bowels spells, diarrhea.									N	11/02/2002	11/05/2002	3		UNK	UNK						1						1	Diarrhoea; Dizziness; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193293	11/14/2002	TX	56.0	56		F	11/14/2002	Pt felt a warm feeling upon leaving the immunization department.  No other significant reactions were noted.  V/S taken, patient observed for 20 minutes.									Y	11/14/2002	11/14/2002	0	N/A	MIL	MIL	Lipitor 40 Mg Glucophage 500 Mg Relafen 500 mg		NKDA			1						1	Feeling hot	FLU3~SANOFI PASTEUR~UO88OAA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0817AA~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0193294	11/14/2002	UT	1.0	0	.9	F	11/14/2002	Febrile 39C 26 hours after injections.  Uncontroled, unconsolable crying dring the night (11/13-11/14).  Tylenol 10mg/kg q6  alternating with Children's Motrin 5mg/kg q8.									Y	10/12/2002	10/13/2002	1		PVT	UNK	none	none	none			1						1	Crying; Pyrexia	DTP~UNKNOWN MANUFACTURER~~UNK~IM~LA~DTP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~UNK~IM~RL~HIB (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~IM~RA~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~IM~LA~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|PNC~PFIZER\WYETH~~UNK~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~UNKNOWN MANUFACTURER~~1~IM~LL~VARICELLA (NO BRAND NAME)~1	USA		Influenza
0193363	11/14/2002	VA	43.0	43		F	11/14/2002	Continued vomiting until administered phenergen.  High fever, diarrhea and sever body shaking from the feeling of being very cold.  My wife took me to Hospital Emergency Room.  Was adminstered Toradol, phenergen, Motrin, Tylenol, mylanta and multiple IVs.				Y					Y	11/07/2002	11/07/2002	0		UNK	MIL		None	Cats and Russian Thistle			1						1	Diarrhoea; Feeling cold; Pyrexia; Tremor; Vomiting	FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0193364	11/14/2002	NY	42.0	42		F	11/14/2002	On 11/13/02, pt. woke up with c/o left arm feeling sore & heavy.  C/o swollen gland in left axilla.  States she fainted at home in the bathroom.  Was seen at Hospital E.D. at 8:15 am, was evaluated and treated with benedryl 50 mg. p.o. Per 60 day follow up: Pt has recovered. 01/20/2003 spoke with pt- finally recovered.				Y					N	11/12/2002	11/13/2002	1	CBC w/ differential:unremarkable	PVT	PVT	Pt routinely takes HCTZ for high blood pressure.  On no other routine medications.	None.	Allegy: codeine Birth defects: none Medical condition(s: high blood pressure			1						1	Myalgia; Oedema; Syncope	FLU3~SANOFI PASTEUR~UO969AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193297	11/15/2002	NH	3.0	3		F	11/04/2002	2 day tactile temp/brought to ER 10/28/02 for intractable vomiting. Admitted hospital for exacerbation asthma, ? of RLL pneumonia, vomiting/discharged 10/31/02/treated with oxygen, IV fluids, IV Ceftriaxone, Phenergan supp. oral amoxicillin.					Y	3			Y	10/24/2002	10/26/2002	2		PVT	PUB	Zyrtec, Vanceril, Singular, Albuterol	NONE	Asthma, global developmental delays, recent onset silent seizures			1						1	Condition aggravated; Pneumonia; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U0904CA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0193298	11/15/2002	OR	78.0	78		F	11/06/2002	Pt had flu shot on 10/16/02 then had nausea/vomiting, diarrhea, feeling weak. Apparently collapsed in apt-found down post three days. Was treated in ICU for pneumonia. Also weak in LE (but reflexes present). Still recovering.  Nurse follow up on 07/21/04 states: Aspiration, DVT  rt upper ext, Mental status change, Bronchospasm, Rash, flu reaction, dehydration, ecchymosis,			Y		Y				Y	10/16/2002	10/21/2002	5	abnorm chest film, Labs abnormal	PVT	OTH		NONE	hypertension, hyperlipidemia, hypothyroid, COPD, Alcoholism, Allergy, Malnutrition, Edema, tobacco abuse,			1						1	Asthenia; Asthma; Deep vein thrombosis; Dehydration; Diarrhoea; Ecchymosis; Fall; Influenza; Laboratory test abnormal; Nausea; Pneumonia; Rash; Respiratory distress; Vomiting	FLU3~SANOFI PASTEUR~U0968AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0193303	11/15/2002	VA	68.0	68		F		Pt stated that on the evening of receiving her flu & pneumococcal vaccination that her right arm  (pneumococal) because swollen from elbow to shoulder. This swelling was painful and lasted 3 days.									Y	11/05/2002	11/05/2002	0		PUB	PUB	ASA prn		NKA		VA02036	1						1	Injection site pain; Injection site swelling	FLU3~PFIZER\WYETH~4020029~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1171L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193304	11/15/2002	CO	71.0	71		F	11/08/2002	Rt arm edematous erythema and warm to touch from shoulder to elbow. Reported by pt-dizziness after inj. 2-3 hrs later pain upper arm with swelling.									U	11/06/2002	11/06/2002	0	NONE	PVT	UNK	Fosomax, multivits	NONE	Osteoporosis, rectal ca, ?		CO02040	1						1	Dizziness; Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U0951AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0172M~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193305	11/15/2002	NC	55.0	55		F	10/31/2002	States she developed headache (top area head) light-headedness, nausea, arm injection site red warm and swollen x 3 days. Pt reports allergies to pcn and amoxicillin but is sensitive to all medications, especially antibiotics. States previous physician always called her in 24 hrs after starting any new medications to make sure she was not having any reactions. Pt reports has hypertension, restless leg syndrome and hypothyroidism. States this was first flu vaccine she received since about 20 years ago. States used to react similarly to vaccine in past. States was born  with part of 2 vertebras missing but has had surgery to correct this. Pt instructed to come to health dept to see nurse practitioner for complaint but she refuses. States feels better now.									Y	10/28/2002	10/28/2002	0		PUB	PUB	Multivitamin, calcium, Neurontin, Synthroid, Premarin, Carbidopa, Chlorthialidone		Restless leg syndrome, hypertension, hypothyroidism, pt states sensitive to all medications, pcn amoxicillin allergy.		NC02107	1						1	Dizziness; Headache; Injection site erythema; Injection site oedema; Injection site warmth; Nausea	FLU3~PFIZER\WYETH~4020022~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0193306	11/15/2002	TX	16.0	16		F	11/08/2002	Left arm red, swollen, injurated area at site, fever and body aches 48 hours after vaccine.				Y					U	11/06/2002	11/06/2002	0	NONE	PVT	PVT	Zyrtec	NONE	NONE			1						1	Erythema; Injection site swelling; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U0909AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1050L~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193308	11/15/2002	AL	56.0	57		F	11/07/2002	Redness, swelling, warmth in 24 hrs after injection, RX; 2cc (8mg) Decadron, Time course rechecked 11/07/02, Resolved				Y					Y	10/30/2002	10/31/2002	1	NONE	PVT	OTH	Premarin, Vapo Cream, lLtensin, Calcium	NONE	NONE			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~EVANS VACCINES~E30152GA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0210M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193309	11/15/2002	IN	43.0	43		F	11/06/2002	Pt developed generalized itching and erythema and hives on neck, arms, and upper torso after receiving vaccine. No respiratory distress. Was given 0.3cc Adrenalin 1:1000 SQ and benadryl 50mgmpo and observed for one hour. Symptoms subsided after treatment.				Y					Y	11/05/2002	11/05/2002	0		OTH	OTH	Zyrtec, Nexium, Orthotricyclen	NONE	Allergy to pcn, Emycin, seasonal allergies			1						1	Erythema; Pruritus; Urticaria	FLU3~EVANS VACCINES~E33092HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0193310	11/15/2002	AL	51.0	51		F	11/07/2002	Reddened hot area approx 2 x 2 warm around injection site. Zyrtec x 5 days and ice to site.									Y	11/05/2002	11/06/2002	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U0588AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193311	11/15/2002	IL	65.0	65		F	11/05/2002	Pain in Muscular Arch in upper left arm (Between elbow and shoulder) in vicinity where flu shot was given hurts when I move my arm in different position.									N	10/08/2002	10/08/2002	0		OTH	OTH	Premarin (?), Diurectic - Water Pills	NONE	Allergy to cat hair or dander, HTN			1						1	Injection site pain	FLU3~SANOFI PASTEUR~UO906BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193312	11/15/2002	OH	87.0	87		M	11/07/2002	Pt had large knot at injection site. Arm is bruised from shoulder to elbow. Pt was seen by his family physician. Pt was told by MD that vaccination just needed to dissolve.									U	10/29/2002	10/30/2002	1	NONE	OTH	OTH						1						1	Contusion; Injection site mass	FLU3~SANOFI PASTEUR~U0922AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193313	11/15/2002	NY	54.0	54		F	11/08/2002	5cm warm red area 24 hours after injection at site of injection.									Y	11/07/2002	11/08/2002	1		PUB	OTH		NONE	Allergic to PCN, Entex LA			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U0910AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193314	11/15/2002	CA	62.0	62		F	10/22/2002	Patient experiences pain from head to shoulder, arm to hand, wrist & thumb, Feels tightness & weak, Flu like symptoms patient was treated with methylprednisolone, From doctor - pain seems to relief by taking two Advil				Y					Y	10/16/2002	10/17/2002	1		OTH	PVT	NONE	NONE/patient	NKA			1						1	Asthenia; Influenza like illness; Pain	FLU3~SANOFI PASTEUR~UO875AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193315	11/15/2002	OR	72.0	72		F	11/04/2002	Left upper arm severe swelling at injection site.									Y	10/16/2002	10/17/2002	1		PVT	PVT	Lithium, Premarin	NONE	BiPolar, Lithium Treatment			1						1	Injection site swelling	FLU3~SANOFI PASTEUR~U0883AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0676M~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193317	11/15/2002	UT	19.0	19		M		Fever, nausea, achy-can't sleep									Y	11/05/2002	11/05/2002	0		OTH	PVT			Seasonal allergies			1						1	Nausea; Pain; Pyrexia; Sleep disorder	FLU3~SANOFI PASTEUR~~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193318	11/15/2002	NV	43.0	43		F	11/04/2002	Approx 2 mins after flu vaccine administered to left deltoid employee reports the following s/s: warm rush, tightness in chest, diaphoresis, fever, anxiety, heart palpitations. She also reports prolonged adverse effects (3-4 days) of fever, diarrhea, nausea, and dizziness.									Y	11/01/2002	11/01/2002	0	NONE	PUB	PVT	NONE	NONE	Asthma, mitral valve prolapse, murmur			1						1	Anxiety; Chest discomfort; Diarrhoea; Dizziness; Feeling hot; Hyperhidrosis; Nausea; Palpitations; Pyrexia	FLU3~SANOFI PASTEUR~U0951Aa~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193319	11/15/2002	TN	45.0	45		M	12/19/2002	On 11/1 pt reports that during the night he noticed a rash and this morning he has rash on trunk. Says no other symptoms. Has not taken any additional medication. He had flu shots for several years without problem. Complete recovery by 11/2/02.									Y	10/29/2002	11/01/2002	3		OTH	PVT	NONE	NONE	NONE			1						1	Rash	FLU3~EVANS VACCINES~E35452NA~7+~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0193320	11/15/2002	IN	62.0	62		F	11/06/2002	Pain and swelling in arm. High blood pressure and high pulse rate. Given 100mg of Atarax ea day and 250mg Keflex 3 times a day. This was done by med check.				Y					Y	11/04/2002	11/04/2002	0		PVT	UNK			Sulfur			1						1	Blood pressure increased; Heart rate increased; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~W0982AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~676M~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193321	11/15/2002	MN	49.0	49		M	11/08/2002	Chills, fever, joint aches, body aches. Onset: 12 hrs after injection duration 72 hrs.									Y	11/04/2002	11/04/2002	0	NONE	UNK	PVT		NONE	NONE			1						1	Arthralgia; Chills; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U0945AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193323	11/15/2002	OK	23.0	23		F	11/08/2002	Small local reaction with erythema and localized tenderness less than palm of hand one hour after injection. There is increased warmth, no systemic symptoms. Pt is very dermatographic. No history of egg allergy.				Y					Y	11/07/2002	11/07/2002	0	NONE	MIL	MIL	NONE	NONE	Naprosyn-hives			1						1	Injection site erythema; Injection site pain; Injection site reaction; Injection site warmth	FLU3~SANOFI PASTEUR~U0704AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193325	11/15/2002	AZ	67.0	67		F	11/08/2002	The day after receiving a flu vaccine and a pneumonia vaccine pt c/o temp 99.6, chills shaking, feeling cold. The left arm, which received the pneumonia vaccine, was extremely sore. She vomited once .A day later, she felt back to normal  after rest and fluids.									Y	10/31/2002	11/01/2002	1		PVT	PVT		NONE	HTN, Osteoporosis			1						1	Injection site pain; Pyrexia; Tremor; Vomiting	FLU3~SANOFI PASTEUR~UO875AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0035M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193326	11/15/2002	VA	60.0	60		F	11/08/2002	Fever, Aching bones, Sore skin, HA, Blurry vision, Severe coughing,Very tired, Ttightness in chest, Large volume green phlem, Sweating, chills, Runny nose and eyes. Most symptoms subsided in 7 days. Coughing continues into 3rd week									Y	10/25/2002	10/28/2002	3		PUB	PUB	Diovan	NONE	Blood Pressure only			1						1	Chest discomfort; Cough; Fatigue; Headache; Hyperhidrosis; Injection site pain; Lacrimation increased; Pain; Pyrexia; Rhinorrhoea; Vision blurred	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193327	11/15/2002	MD	46.0	46		M	11/08/2002	Generalized rash, itching, swelling. Seen in ED 11/3/02 0300. Tx'd with steroids and Benadryl. Esophagitis 2 hrs steroids used to tx sx. Followed up with family doc 11/5-11/6. Still experiencing itching, rash. Now c/o muscle and joint aches.				Y					N	11/01/2002	11/02/2002	1		OTH	PVT		NONE	NONE			1						1	Arthralgia; Myalgia; Oesophagitis; Pruritus; Radiation injury	FLU3~SANOFI PASTEUR~UA0904CA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193328	11/15/2002	CT	69.0	69		F	11/08/2002	L sore red swollen arm very tender T101.4 nauseated muscle weakness and muscle ache. Dr stated was due to antigens battling. Pt has history of strep from which she developed pneumonia. Dr advised Tylenol fluids and heat to arm. Denies celluliis as had sweats feels better 11/8/02. Has a little muscle weakness 11/8/02.									Y	11/04/2002	11/05/2002	1	NONE	PUB	PVT	Lipitor, Actonel, Vioxx, Diazide	NONE	History of strep infection, pneumonia			1						1	Hyperhidrosis; Injection site erythema; Injection site oedema; Injection site pain; Muscular weakness; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~U0911BA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0210M~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193329	11/15/2002	CT	69.0	69		F	11/08/2002	Did not feel well going to bed woke up during the night and could only walk to bathroom with difficulty weakness loss of feeling in legs and she felt nauseated lasted 3 hrs had muscle pain the following day and by the 7th she was feeling better.									Y	11/04/2002	11/05/2002	1	NONE	PUB	PVT	Levoxyl, Diovan	NONE	Fibromyalgia, mitral prolapse			1						1	Asthenia; Malaise; Myalgia; Nausea; Paralysis	FLU3~SANOFI PASTEUR~U0911BA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193330	11/15/2002		0.5	0	.5	M	11/13/2002	Information has been received from an investigator regarding a 6 month old male who received his third dose of study vaccine along with DTaP (manuf unk), IPV, and influenza virus (manuf unk) vaccines on 10/29/02 as part of the study, A Phase III Randomized Study to Evaluate the Safety of the 9-Valent Pneumococcal, Meningococcal Group C Saccharide-CRM197 Conjugate Combination Vaccine Comparred to Licensed 7-Valent Pneumococcal Conjugate Vaccine (Prevnar) Administered to Healthy Infants. The reporter noted that at the time of immunization, the infant had viral gastroenteritis with excessive weight loss. Approximately 15 to 20 minutes post-vaccination, the infant developed  limb shaking and his eyes rolled back. He also developed hives on his face and was crying intermittently. Emergency services were called and the infant was seen in an ER. Urinalysis and serum electrolyte test results were normal. A CBC showed a slightly high white blood cell count of 18.7. A CT scan was normal. A physician exam revealed no abnormalities and a diagnosis of seizure was made. The family physician suspected an allergic reaction to egg protein in the influenza vaccine. On 10/30/02, the infant was seen by an allergist who indicated the possibility that the infant had aspirated and developed laryngospasm mimicking like seizure activity. Results of egg allergy skin tests performed that day were negative. The investigator considered the events to be medically important (OMIC). Both the medical monitor and the investigator agreed that seizure and hives (both expected per the investigator brochure) were possibly related to study vaccine and concomitant vaccine administration.									U	10/29/2002	10/29/2002	0	Blood electrolytes NOS normal; computerized tomogram normal; full blood count WBC-slightly high at 18.7; skin test negative for eggs; urine analysis normal	UNK	UNK	UNK		Gastroenteritis viral NOS, weight decreased		HQ5050205NOV2002	1						1	Agitation; Convulsion; Eye movement disorder; Tremor; Urticaria; White blood cell count increased	DTAP~UNKNOWN MANUFACTURER~~UNK~IM~RL~DTAP (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|IPV~SANOFI PASTEUR~~UNK~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|UNK~UNKNOWN MANUFACTURER~~3~~LL~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA		Influenza
0193342	11/15/2002	NC	15.0	1	.5	M	11/07/2002	2 days after the vaccines, a warm splotchy rash developed distal to the injection site left thigh, The child had no fever or signs of illness. We recommended Benadryl and Motrin.				Y					U	11/05/2002	11/07/2002	2	NONE	PVT	PUB	NONE	NONE	NKA			1						1	Feeling hot; Rash; Rash maculo-papular	DTAP~SANOFI PASTEUR~UO583DA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UO879AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UA727AA~4~IM~LL~HIB (ACTHIB)~1	USA	Emergency room visit	Influenza
0193355	11/15/2002	MS	5.0	5		M	11/08/2002	Child presented to Health Department for DTap, was given Flu vaccine and DTap. Child cried 45 minutes after vaccine saying his right arm hurt. The next day the vaccine site developed a knot the size of a haf-dollar, was erythematous and hot to the touch. Child ran temperature of 99-100 degrees. 48 hours later, site increased in size to silver dollar area with pain. ER MD diagnosed as allergic reaction. Prescribed Pediamed steroids and a topical steroid cream.				Y					Y	11/06/2002	11/07/2002	1		PUB	UNK		NONE	NONE			1						1	Hypersensitivity; Injection site erythema	DTAP~SANOFI PASTEUR~U0584CA~5~IM~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U0971AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193362	11/15/2002	CA	43.0	43		F	11/13/2002	Felt cold, was shivering and shaking. Breathing but not normal.									U	11/13/2002	11/13/2002	0		UNK	UNK						1						1	Chills; Feeling cold; Respiratory disorder; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0193365	11/15/2002	MN	50.0	50		M	11/15/2002	I received the vaccine on Nov 5th at 8:30 AM.  At 9:15 PM on November 6th, I had an episode of severe dizziness. What I was looking at was percieved to be spinning rapidly as if on a disc. Standing was impossible.  This has continued through today, Nov 15, 2002, although slightly letting up in intensity. The percievd motion now is a back and forth rather than a spinning disc. It is most prevalent in the morning and evening when getting up or laying down, although it does occur during the day, but less intensly.  Additionally, there is a constant, but low level, sense of dizzyness (although no spinning is associated with this)-- similar to a light headedness sensation.									Y	11/05/2002	11/06/2002	1		UNK	PVT	None	None	None			1						1	Dizziness	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193366	11/15/2002	OH	30.0	30		F	11/15/2002	Patient developed itching (felt like bugs crawling all over skin), no rash, redness, edema, nausea or warmth at injection site.  Rx'd with PO Benadryl				Y					Y	11/13/2002	11/13/2002	0		MIL	PUB		dx: endometrosis, IBS, arthritis	all: aspirin, sulfa, codeine			1						1	Pruritus	FLU3~SANOFI PASTEUR~U0958AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193368	11/15/2002	PA	36.0	36		M	11/15/2002	3x2 inch Rash on inside of left upper arm.									U	11/06/2002	11/08/2002	2		MIL	MIL	None	None	Same reaction occurred after Anthrax shot number 5	10 July 1999~Anthrax (Biothrax)~5~33.20~In Patient		1						1	Rash	ANTH~EMERGENT BIOSOLUTIONS~FAV063A~7+~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~UO983AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193369	11/15/2002	WV	27.0	27		F	11/15/2002	Patient received a Flu shot in one deltoid and Pneumonia in the other.  Both arms were red and swollen.  Arms were slightly pink and had raised sores.  Patient was treated with ice packs. Chest Heavy- Heart jumping out of chest. Discharge summary states neck pain, nausea, vomiting, headache, urinary tract infections, gastroenteritis. msc					Y	1			Y	11/13/2002	11/13/2002	0		UNK	UNK	NONE	NONE	NONE			1						1	Chest pain; Erythema; Gastroenteritis; Headache; Nausea; Neck pain; Oedema; Vomiting	FLU3~SANOFI PASTEUR~U0937AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0358M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0193370	11/15/2002	GA	54.0	54		F	11/15/2002	After administration of Pneumovax in Right Deltoid and Flu Vacc in Left Deltoid, both areas bruised, but the right arm later that day began swelling and hurting.  Today, pt states arm has gotten better, but still has swelling ,tenderness and redness with central bruising.No shortness of breath or chest pain.									U	11/11/2002	11/11/2002	0	none	PVT	UNK	Vioxx, premarin cream, aspirin	none, routine pap smear	chronic back/neck pain, h/o breast cancer, migraines			1						1	Erythema; Oedema	FLU3~EVANS VACCINES~E3052GA~2~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0445M~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193460	11/15/2002	MA	24.0	24		F	11/15/2002	Received statement from clinical support licensed practical nurse that she had spoken to a volunteer who coordinated a public flu vaccine clinic site that a woman who had received the flu vaccine on 11/13/02 had called to say that she had hives all over her body.  She added that she has had hives for 2 years and is taking Zyrtec every day with good control until she had the flu shot. Staff nurse phoned the individual at 3:20pm on 11/13/02.  The nurse determined that the woman does not have a primary care provider.  She denied shortness of breath, swelling or difficulty swallowing.  Nurse recommended that the woman go to  emergency treatment center, and if she developed any of the above symptoms, she should go by ambulance/rescue.  Telephoned individual on 11/14/02 and again on 11/15/02.  She did go to minor emergency room, received treatment, and the hives resolved.				Y					Y	11/13/2002	11/13/2002	0		PUB	PUB	Zyrtec		Individual has had hives for 2 years			1						1	Urticaria	FLU3~SANOFI PASTEUR~U0904CA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193461	11/15/2002	CA	55.0	55		F	11/15/2002	Had shot on Oct. 30th. Started(Oct 31st) with Headace next day and a temp. of 102-101 for 3days! Called Dr. on Fri. night(Nov. 1st) 1-530-742-1394. He gave me a RX for Rimantadine 100mg-Twice a day!! took that for 10 days. Fever was finally done to 97.5 on Tuesday(Nov. 5th)				Y					Y	10/30/2002	10/31/2002	1		PUB	UNK	URSO 250mg	No	PBC(Primary Billary Cirrosis) Stage4 I am on the Transplant list at a Hospital			1						1	Headache; Pyrexia	FLUX~UNKNOWN MANUFACTURER~?~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0675m~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193466	11/17/2002	NC	27.0	27		F	11/17/2002	Symptoms:  local erythema, induration at the injection site within 24 hours; followed by the progression of the erythema to include the entire dorsal surface the the left arm;  patient was diagnosed with cellulitis and begun on keflex 500 mg po QID this evening by a local emergency room				Y					Y	11/15/2002	11/16/2002	1		PVT	UNK		none	Asthma, allergy to thimerosal (not anaphylaxis)			1						1	Cellulitis; Erythema; Injection site induration	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0193467	11/17/2002	MO	2.0	2	.0	F	11/17/2002	Fever approx. 100.5 degrees from 3:00, 11/15/02 until 11/17/02, treated with Children's Ibuprofen; Vomitting 2:30AM 11/16/02; Acted dizzy 11/15/02;									Y	11/13/2002	11/15/2002	2		PUB	PUB	Albuterol, Pulmacort	Cough (asthma-related)	Asthma			1						1	Dizziness; Pyrexia	FLUX~UNKNOWN MANUFACTURER~unknown~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193378	11/18/2002	MA	53.0			F	11/14/2002	A 63 year old female reported that she had a reaction to the influenza virus vaccine (manuf unk) in approximately 1992 when she was 53 years old. Within 45-60 minutes of receiving the vaccine, she experienced chest tightness, wheezing, bronchospams, hives, itching, and some cramping and diarrhea. She described the reaction as mild anaphylaxis. In later years, she received several smaller doses of the flu vaccine, but still reacted with the same symptoms. One year, she received 1/4 of a normal dose, along with prednisone, and did not experience a reaction. Another year, she received a skin test with the Parke-Davis flu vaccine, and she also reacted. She is normally treated with hydroxyzine HCl for the reaction. The pt noted that she was allergic to antibiotics and to sulfites. Anaphylaxis was considered medically important. No further info was available as of the date of this was reproted.									Y				UNK	OTH	OTH	UNK	UNK	Asthma NOS; hypersensitivity NOS; rheumatoid arthritis; ovarian cyst		HQ5197812NOV2002	1						1	Anaphylactic reaction; Bronchospasm; Chest discomfort; Diarrhoea; Muscle spasms; Pruritus; Urticaria; Wheezing	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0193385	11/18/2002		81.0			F		An ASPP (Anonymised Single Pt Print) was received from the regulatory authority on 11/4/02, concerning an 81 year old female pt who collapsed and was hospitalized after receiving a Fluvirin vaccine on 10/18/02. On 10/18/02, the pt collapsed after receiving a Fluvirin vaccine on 10/18. At the time of reporting the pt had recovered without any neurological sequelae. The reporter assessed the event as possibly vasovagal in origin. No further info was given. There was insufficient info to determine to reporter's causality assessment.					Y				U	10/18/2002	10/18/2002	0		UNK	UNK					PJP200200660	1						1	Syncope; Syncope vasovagal	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0193386	11/18/2002	MN	26.0	26		F	11/15/2002	Approx. 30 seconds after injection became unresponsive and stopped breathing. Cyanotic and seizure activity. Rescue breathing administered, carotid pulse present. Began cheyne-stokes breathing and gradually became responsive to verbal stimuli approx 3-4 minute after injection.			Y	Y					Y	11/12/2002	11/12/2002	0		OTH	OTH	Allegra, Propanolol	NONE				1						1	Coma; Convulsion; Respiratory disorder; Apnoea; Coma; Convulsion; Cyanosis	FLU3~SANOFI PASTEUR~U0924EA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0924EA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening	Influenza
0193390	11/18/2002	WI	43.0	43		F		Patient complained of burning and aching at site immediately after injection. Returned to health center 2 hours later with flushed face and hot feeling. Rash localized to cheeks and chin (erythema). No other rashes/hives present.				Y					Y	11/14/2002	11/14/2002	0		PVT	PVT	Ibuprofen, Diclofenac	Tendonitis left knee	ASA, PCN			1						1	Flushing; Injection site reaction; Pain; Rash; Skin burning sensation	FLU3~PFIZER\WYETH~U0987~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0193393	11/18/2002	FL	3.5	3		M		High fever of 105. Spent most of night in bath tub. Fever lasted 3 days. No antibiotic Tylenol/Advil only									Y	10/31/2002	11/01/2002	1		UNK	UNK	NONE	NONE	Failure to thrive			1						1	Pyrexia	FLU3~SANOFI PASTEUR~U0925AA~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193394	11/18/2002	NC	8.0			F	11/13/2002	10/21/02 Patient complained of feeling funny, blurred vision/went black, complete loss of vision. No loss of postural tone or LOC. Shaking per school staff. Pallor noted when mom arrived. Continued with complaints of vision loss at office but positive response to visual threat and other visual challenges, though also claimed unable to see at times.				Y					Y	10/16/2002	10/21/2002	5		PVT	PVT		None				1						1	Blindness; Malaise; Tremor; Vision blurred	FLU3~SANOFI PASTEUR~U0880AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193395	11/18/2002	KY	40.0	40		F	11/14/2002	Flu vaccine given left deltoid. 15 minutes later, patient complained of left shoulder - red rash noted on back and shoulder. Emergency protocol followed. Benadryl PO per MD ordered. Ice applied.										11/14/2002	11/14/2002	0	None	OTH	PUB	Appendix; Diet meds	None	NKA		KY2002048	1						1	Erythema; Rash	FLU3~SANOFI PASTEUR~U0886AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193396	11/18/2002	AL	39.0	39		M	11/07/2002	Employee was given flu shot on 10/4/02. About a week after that he developed some mild flu-like symptoms that lasted about 4 days. He improved and felt normal but around October 30 he began to have stomach  pain and aching of body, no fever or unrelated symptoms. he went home from work early went to bed and felt some better in the morning. In 2 days he was back to normal health, feels symptoms were related to flu vaccine.										10/04/2002				UNK	UNK			NONE			1						1	Abdominal pain upper; Influenza like illness; Pain	FLU3~SANOFI PASTEUR~U0888AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193397	11/18/2002	WI	82.0			M		Left elbow red, swollen and painful to touch													NONE	UNK	UNK						1						1	Erythema; Joint swelling; Pain	FLU3~SANOFI PASTEUR~U0888AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193398	11/18/2002	WI	50.0	50		F	11/04/2002	Patient had fluzone on 10/19/02. Presented to urgent care on 10/21/02 with left arm swelling and redness radiating up left side of neck. Swollen glands in neck.										10/19/2002	10/21/2002	2	CXR with Iordotic view	UNK	UNK						1						1	Erythema; Lymphadenopathy; Swelling	FLU3~SANOFI PASTEUR~U0888AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193400	11/18/2002	WA	5.0	5		M	11/15/2002	Upper arm redness, swelling from top of shoulder to elbow. Evaluated 11/13/2002. Chart states reaction to immunization. Benadryl q 6 hour, Duracef x 10 days				Y					Y	11/11/2002	11/12/2002	1		PVT	PUB	Miralax	None	Constipation, Febrile Seizure history, Allergy to amoxicillin			1						1	Erythema; Swelling	FLU3~SANOFI PASTEUR~U0883AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193401	11/18/2002	OK		58		F	11/17/2002	Large cellulitis / exanthem, warm to touch at site of vaccination, Left arm pain, Numbness									U	11/05/2002	11/07/2002	2		PUB	PVT		NONE	NKDA, Hypothyroidism, HTN			1						1	Cellulitis; Hypoaesthesia; Injection site pain; Injection site reaction; Injection site warmth; Rash	FLU3~SANOFI PASTEUR~UO943AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0872M~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193402	11/18/2002	GA	37.0	37		F	11/12/2002	Patient reports had feelings of feeling high as if she had received Stadol 1.5 hours after flu vaccine. Lasted 24 hours; went to ER at time feeling started. MD thought it could be reaction with other meds.				Y					Y	11/02/2002	11/08/2002	6	Elevated blood glucose	PUB	PUB	Glucophage, VIOXX, Lipitor, Welchol, NTO, Zoloft	None	Diabetes, Heart disorder, Hyperlipidemia			1						1	Blood glucose increased; Euphoric mood	FLU3~PFIZER\WYETH~4020025~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0193403	11/18/2002	GA	32.0	32		F	10/31/2002	Pt noticed soreness, redness, and swelling of arm this am while dressing. Noticed few whelps around site also. Insisted pt to apply ice pack x 15 minutes Q20 PRN Benadryl 25-50 mg by PO now. Call 911 if develops wheezing or SOB									U	10/30/2002	10/31/2002	1	NONE	PUB	PUB	NONE		NONE			1						1	Injection site erythema; Injection site oedema; Injection site pain; Urticaria	FLU3~PFIZER\WYETH~4020025~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0193404	11/18/2002	IL	68.0	68		F	10/30/2002	Received Td on Monday 10/21/02. Received flu vaccine 10/25/02. Monday 10/28/02 noticed area of bumps and egg size swelling on left arm; sites of both injections. Area sore and hot to touch. Per patient, seen in ER and diagnosed with cellulitis 10/29/02. Put on antibiotic and better today 10/30/2002.				Y					Y	10/25/2002	10/28/2002	3		PUB	PVT	None	Healing Burn on right hand	Hx of breast cancer; Right side mastectomy		IL02058	1						1	Cellulitis; Feeling hot; Injection site swelling	FLU3~SANOFI PASTEUR~U0946AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193405	11/18/2002	LA	65.0	64		F	11/04/2002	Patient called 10/30/02 stating had large local reaction after pneumonia vaccine last year with redness, swelling and red streaks coming from site. States also had headache for 2 days, stiff neck and some breathing problems. Had headache a few hours after shot. Within 48 hours went to hospital for Celestone shot. Within 1 hour, symptoms relieved.				Y					Y	11/13/2001	11/13/2001	0		PUB	PUB	None		History of asthma, Allergic to codeine, PCN, environmental allergies		LA021101	1						1	Cellulitis; Dyspnoea; Headache; Injection site erythema; Injection site swelling; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U0698AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~469133~2~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0193407	11/18/2002	CA	6.5	6		M	11/11/2002	Received flu shot 11/06/2002, next day after had large area of erythema on upper left arm and trunk. Worsened over next 24 hours, fever 101.8 on 11/08/2002. Tx for possible cellulitis on 11/08/2002									Y	11/06/2002	11/07/2002	1	CBC,ESR,BiD,Cx--all negative	PVT	PVT		NONE	Ex 30 week premie, Asthma			1						1	Injection site erythema; Pyrexia	FLU3~SANOFI PASTEUR~U0905FA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193408	11/18/2002	MA	73.0	73		F	10/29/2002	Arm became red & swollen day following immunization, Very sore worse next day, Saw PCP 3rd Day Infection? cellulitis?, Rx Cephalexin 500 mg TID  10/16/2002 at 07:77 am when she woke up, day after she received flu shot noticed redness and swelling.				Y					Y	10/15/2002	10/16/2002	1	NONE	PVT	PUB		NONE	NKA			1						1	Cellulitis; Infection; Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~UO87AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193409	11/18/2002	NC	16.0	16		F	11/11/2002	Red swollen area at site of flu shot. Complained of arm pain. 4x4 swollen area. Local reaction. Temp 97				Y					Y	11/08/2002	11/08/2002	0	NONE	PVT	PUB	Numerous medications, patient is multi handicap child		Ampicillin, Bactrim, Vancomycin			1						1	Injection site erythema; Injection site swelling; Pain	FLU3~PFIZER\WYETH~4020024~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0193410	11/18/2002	NY	57.0	57		F	11/09/2002	6 hours after receiving vaccine became very achy with pain in left upper arm radiating to back and up to neck.				Y					Y	10/25/2002	10/25/2002	0		PVT	PVT		NONE	NONE			1						1	Pain	FLU3~EVANS VACCINES~E32072GA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0193411	11/18/2002	MN	74.0	74		F	11/09/2002	About 4-5 hrs after vaccine was given I developed a sore throat and was hoarse for approximately 5 days (2 days of this I had no voice)									Y	10/25/2002	10/25/2002	0		PUB	UNK	Atenolol, Glucotrol, Vit E & Multivitamin, Lipitor, Lisinopril, Coated Aspirin	NONE				1						1	Dysphonia; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U0938AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193412	11/18/2002	MI	51.0	51		F	10/31/2002	Left arm numbness for 1 day. Shoulder pain for 2 days. Hips and both knees pain and difficulty walking days 4 through 11. Treatment: Motrin, rest, heat to joints.									Y	10/21/2002	10/22/2002	1		PUB	OTH	Lopressor, Cenestin, Prometrium	Root canal in progress	Sulfa, Menopause, SurapVentricular Tachycardia	Flu Symptoms~Influenza (Seasonal) (no brand name)~1~41.00~In Patient		1						1	Arthralgia; Difficulty in walking; Hypoaesthesia; Shoulder pain	FLU3~SANOFI PASTEUR~U0911AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193413	11/18/2002	TX	32.0	32		F	11/07/2002	Hives, swelling in hands, face, feet. Went to hospital for treatment.									Y	10/28/2002			None	PVT	PVT	None	None	None			1						1	Face oedema; Oedema peripheral; Urticaria	FLU3~SANOFI PASTEUR~U0966BA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193414	11/18/2002	WA	33.0	33		F	11/05/2002	Pins and needles back of arm. Itchy skin. Some SOB; no fast or deep breathing. Treatment: Epinephrine right deltoid SC									Y	11/05/2002	11/05/2002	0		OTH	PVT	Effexor	None	None			1						1	Dyspnoea; Paraesthesia; Pruritus	FLU3~PFIZER\WYETH~U0897012~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0193415	11/18/2002	NY	58.0	58		F	11/01/2002	10cm erythema, warmth, slight induration. Left upper arm from shoulder to elbow swollen. Treatment: cool compresses, elevation, Clarinex, Prednisone				Y						10/29/2002	10/30/2002	1	None	PVT	PVT	Flexor, Claridine, Olsakid	NOne	Hay fever, Sulfa, PCN			1						1	Feeling hot; Injection site erythema; Injection site induration; Swelling	FLU3~SANOFI PASTEUR~00311AA~3~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193416	11/18/2002	WI	24.0	24		F	11/11/2002	Within 1-2 minutes after receiving influenza vaccination, client felt dizzy, weak, felt like going to pass out. Diaphretic and pale. BP taken; pulse.									Y	11/11/2002	11/11/2002	0	BP, Pulse	PUB	PUB	Advir, Rhinocort	None	Mold, Pollen, Cats			1						1	Asthenia; Dizziness; Pallor	FLU3~SANOFI PASTEUR~U0886AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193417	11/18/2002	ME	48.0	48		F	11/08/2002	Flu shot given 10/31/02. Within 1 hour, experienced wheezing, SOB. Used Albuterol inhaler. Symptoms cleared within 15 minutes. Very large welt on left upper arm where injection given.									Y	10/31/2002	10/31/2002	0		PVT	PVT	Seravent inhaler	None	Asthma			1						1	Dyspnoea; Urticaria; Wheezing	FLU3~EVANS VACCINES~E34682HA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0193418	11/18/2002	NC	72.0	72		F	11/11/2002	Upper left arm very sore for 2 weeks after vaccine given. Some swelling also.									Y	10/28/2002	10/28/2002	0		PUB	UNK						1						1	Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193419	11/18/2002	TN	70.0	70		F	11/05/2002	Began having itching, swelling and pain at injection site 1 hour after immunized. Local reaction spread down left arm, swelled, reddened and painful down elbo. Saw MD next day who said was allergic to the vaccine or something in it.				Y					Y	11/01/2002	11/01/2002	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Erythema; Injection site swelling; Pain; Pruritus	FLU3~SANOFI PASTEUR~U0925AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0111M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193434	11/18/2002	OR	11.0	11		F	11/08/2002	Left arm swollen, red, area size of golf ball, feels warm to touch, no difficulty breathing, but state does not feel well, no emesis. All info by report to triage line at clinic.									U	11/07/2002	11/07/2002	0	NONE	PVT	OTH	Keflex, Ritalin	NONE	ADHD			1						1	Injection site erythema; Injection site oedema; Injection site warmth; Malaise	FLU3~SANOFI PASTEUR~U0883AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~SMITHKLINE BEECHAM~755A2~UNK~IM~LA~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0351M~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0193578	11/18/2002	GA	55.0	55		F	11/18/2002	pt returned to vaccine area 1 hr after receiving flu vaccine.Complained of funny taste in mouth,throat tightening,trouble swallowing,entire left arm sore.Pt took sips of water with Benadryl. Emergency rescue team called,pt stated she was feeling better and did not require hospitalization									Y	11/06/2002	11/06/2002	0		UNK	PVT	Prevacol,Lisonopril		High BP,cholesterol			1						1	Dysgeusia; Dysphagia; Pain; Throat tightness	FLU3~PFIZER\WYETH~4020019~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0193579	11/18/2002	PA	32.0	32		M	11/18/2002	Felt pain in shoulder in PM hours. Pain migrated to elbow and then onto the hand. Numbness in right hand. Index,middle finger and thumb are all numb.									N	11/15/2002	11/17/2002	2		MIL	MIL						1						1	Hypoaesthesia; Pain	FLU3~SANOFI PASTEUR~UO983AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193580	11/18/2002	MI	56.0	55		F	11/18/2002	Dizzy, temperature, hot/cold through Wed and part of Thur.  Then, diahrea as well as continued headache....in other words the flu.  I do understand that the shot probably did not cause this, but felt I should report anyway.									Y	11/11/2002	11/11/2002	0	Vaccine code: 90658 Administration Code: 90471 TAXID: 382-693-137	UNK	UNK		none	none			1						1	Diarrhoea; Dizziness; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193472	11/19/2002	LA	70.0			F	11/14/2002	It was reported by a health care professional concerning an approximately 70 year old female who resides in a nursing home, and was administered Fluzone SV 2002-2003 USF (Lot number not reported). The patient was inadvertently administered 5 cc  of the vaccine instead of 0.5 cc in the deltoid approximately 10 days ago. Approximately 4-6 hours after administration, the patient experienced vomiting and other unspecified symptoms. A family member brought the patient to the physician's office. She then went to the emergency room and was admitted to the hospital and at some point was placed on a ventilator. Additionally, there were several episodes over an eight day period while on the ventilator where the patient's heart stopped beating. A temporary pacemaker was used for a few days before a permanent pacemaker was inserted. The patient's lips were swollen during the hospital stay. This information was provided to the  reporter by the patient's great niece. As per the reporter, the niece did not know what the impression of the treating physician was at the hospital. The patient's son can provide time more information if unable to obtain from the nursing home. It was not reported whether the patient recovered.				Y	Y	8			U	10/01/2002				OTH	OTH					U200200972	1						1	Face oedema; Medication error; Myocardial infarction; Respiratory disorder; Vomiting	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0193473	11/19/2002	MA	62.0	62		F	11/12/2002	Nausea, vomiting, SVT. Rx'ed with Digoxin and Cardiazem. Medical records states bradycardia. msv				Y	Y	3			Y	11/05/2002	11/05/2002	0	Abd CT pending to R6 pancreatic abn or ret. UGI with widened horizontal route of duodenal scap	PVT	PUB		NONE	Sulfa Medical records state hypertension, hypothyroid. msv			1						1	Bradycardia; Laboratory test abnormal; Nausea; Supraventricular tachycardia; Vomiting	FLU3~SANOFI PASTEUR~U0897AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0193475	11/19/2002	TX	42.0	42		F	11/12/2002	Arthus-type and fever 101-102 degrees, body aches, unable to raise arm over head, severely red and swollen, tender arm. Sx lasted ~ 4-5 D.				Y					N	11/07/2002	11/08/2002	1	NONE	PVT	PVT	Loestrin and estradiol, Urivasc	NONE	Anesthesia			1						1	Hypokinesia; Injection site erythema; Injection site oedema; Injection site pain; Pain; Pyrexia; Type III immune complex mediated reaction	FLU3~EVANS VACCINES~E33702HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1353L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193476	11/19/2002	MA	33.0	33		F	11/14/2002	Pt became weal, pale, diaphoretic, shallow breathing and dizzy- unable to converse, stand, or hold head up. BP 102/58 pulse- unable to feel at first Epinephrine given P58-64. Ambulance called- follow up at hospital.				Y					Y	11/14/2002	11/14/2002	0	Tuberculin PPD Aventis (L)  C0834AB  left forearm  11/12/2002	PUB	PUB	UNK	NONE	UNK			1						1	Dizziness; Flushing; Hyperhidrosis; Hyperventilation; Hypokinesia; Urticaria	FLU3~SANOFI PASTEUR~U0953AA  exp 06~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193477	11/19/2002	NC	64.0	64		F	11/13/2002	Reported to us 11/13/02. Received Td 11/5/02 left deltoid. Started with rash over left shoulder on 11/8/02. States lips and face also swelled and turned red. Denied any problems breathing at that time. Used hydrocortisone cream. Better today. Patient to continue cream on rash; seek attention if breathing problems develop. Instructed to inform other health care providers of reaction. She has a scheduled MD appointment on 11/15/02.										11/05/2002	11/08/2002	3		PUB	PUB		None				1						1	Erythema; Face oedema; Rash; Swelling face	FLU3~PFIZER\WYETH~4020027~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~SANOFI PASTEUR~U0528AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0193478	11/19/2002	MS	41.0	41		F	11/08/2002	Influenza vaccine given 11/5/02 L deltoid. Became red and swollen in pm-14cm x 10 1/2cm itchy-warm to touch. Looks better todday. No PMD visit made or desired. Taking Benadryl/Tylenol.									Y	11/05/2002	11/05/2002	0		PUB	PUB	Hydrocodone	NONE	Three buldging spinal discs		MS02033	1						1	Injection site erythema; Injection site hypersensitivity; Injection site oedema; Injection site warmth; Pruritus	FLU3~PFIZER\WYETH~4020030~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0193479	11/19/2002	OR	40.0	40		F	11/18/2002	14x14 swelling, hot, painful over 24 hours. Patient can't move arm at all.									U	11/14/2002	11/14/2002	0	None	PVT	UNK		None	None			1						1	Feeling hot; Joint range of motion decreased; Pain; Swelling	FLU3~SANOFI PASTEUR~U0919AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0165M~7+~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193480	11/19/2002	MS	66.0	66		F	11/08/2002	11/6/02 pneumonia vaccine given. R arm 14xmc 17cm red, raised area. 11/6/02 flu vaccine given L arm 5cmx 4cm red, raised area. Was splotchy red day of imm. Today all areas remained-but not getting any larger.									Y	11/06/2002	11/06/2002	0		PUB	PUB	Celebrex, Nitroglycerine, Flextra DS, Lipitor, Fossamax, HCT 2	NONE	HTN, asthma, angina		MS02034	1						1	Injection site erythema; Injection site swelling; Rash maculo-papular	FLU3~PFIZER\WYETH~4020030~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0445M~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193482	11/19/2002	CA	52.0	52		F	11/11/2002	Pain at vaccine site with extensive redness and streaking. Pain started immediatley after vaccination. Redness started 24 hours post vaccine.				Y					Y	11/06/2002	11/07/2002	1		PVT	UNK		NONE	Splenectomy - traumahc			1						1	Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U0885AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1353L~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193483	11/19/2002	ND	49.0	49		F	11/12/2002	States had flu shot about 11am and started not feeling well about 3pm-felt chilled, achy, tired, throat felt raspy. States also had lower back discomfort (pre-existing problem). Took Tylenol about 7pm and checked her temp at about 8pm and temp was 100.8 degrees. States L arm felt hard and hot and sore. States her sx. reminded her of times she reacted at times to past allergy injections. Did not seek medical attention. States OK next day except for feeling tired.									Y	11/08/2002	11/08/2002	0		PUB	PUB	Celebrex, Neurontin, Claritin, Gulfedisen	NONE	Asthma-good control, fibromyalgia, soft tissue injury, spinal injury, allergies to meds and environmental		ND0219	1						1	Chills; Dry throat; Fatigue; Injection site induration; Injection site pain; Injection site warmth; Malaise; Musculoskeletal discomfort; Pain; Pyrexia	FLU3~PFIZER\WYETH~4020025~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0873M~2~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193484	11/19/2002	SC	59.0	59		F	10/28/2002	Received Td 10/23/2002. Next day pt noticed pain, redness, swelling right deltoid area that spread down right arm over next few days. Seen MD on 10/28/2002 to evaluate reaction. Right upper arm was warmer than left with redness and induration over middle  1/3 of upper arm. Had taken Benadyl.				Y					Y	10/23/2002	10/24/2002	1		PUB	OTH	Substitue for Ogen, Atenolol, HcT2	NONE	increase blood pressure		SC0250	1						1	Feeling hot; Injection site erythema; Injection site induration; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~4020021~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~SANOFI PASTEUR~U0524AA~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0193485	11/19/2002	AL	56.0	56		F	11/12/2002	Within 1 hour of vaccine started having prickly like feeling in hands, arms, legs, spreading to enter body. Itching then raised red rash covering arms more then entire body. Started Benadryl 25mg every 4-6 hours. Became slightly SOB 11/9/2002. Continue to take Benadryl 25mg every 4-6 hours. Has not called to see MD. 11-15-02 talked with client - saw Dr.; gave rx for Medrol park still complained of prickly sensation, rash present as then before.									N	11/07/2002	11/07/2002	0		PUB	PUB	Synthroid .75mg qdp, Vidol .5mg qdp	NONE	hypothyrodism			1						1	Pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~U0877AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193486	11/19/2002	OH	63.0	63		M	11/05/2002	Client received flu shot on 11/3/02. On 11/5/02 he noticed his left arm was sore and reddened (size of baseball) and swollen below where he got his flu shot. He called his physician and was told to take Ibuprofen if painful and use ice. If no better, he was to see the doctor. 11/4/02 pt called and rednessless and less soreness of arm.									Y	11/03/2002	11/05/2002	2	NONE	OTH	PVT	Nasocort, BP meds	NONE	HTN, allergies		OH0043	1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~EVANS VACCINES~E32072GA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0193488	11/19/2002	MI	66.0	66		F	11/19/2002	Became diaphoretic, weak, shaky within 15 minutes of vaccination. Face flushed. pre temp 96.8 degrees up to 98.2 degrees-decreased 97.3, decreased 97.2 degrees.									Y	11/14/2002	11/14/2002	0	NONE	OTH	OTH	Atenolol, calcium, Zantac, Attace, Leuothyroxine, Ditropah, ferrous sulphate, Paxil Cr, Zestril		S/P hip replacement; allergies (alcohol, Darvon, fish, dairy, tea, tangerines, raw apples, tape (surgical), Talwin, all nacarotics, Demerol, morphine, Tylenol #3, sulfa)			1						1	Asthenia; Hot flush; Hyperhidrosis; Tremor	FLU3~EVANS VACCINES~E35822KA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0193489	11/19/2002	GA	67.0	67		F	11/11/2002	Pt had flu vaccine in left deltoid 10/29/02. She reports that the next day she began to have some swelling and redness of the arm. She is here today for assessment. There is redness, about a 3x3in. circle toward the inner aspect of the left arm just above the elbow along with a little swelling and slight tenderness. The redness is below where the shot was given. Advised her that this can happen sometimes and that she needs to apply a cool compress as needed and take Tylenol q 4-5 hrs. Inst. to let us know if this does not improve.									Y	10/29/2002	10/30/2002	1	NONE	PUB	UNK		NONE				1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~EVANS VACCINES~34682HA~3~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0193490	11/19/2002	MA	19.0	19		F	11/14/2002	Pt returned to site of clinic with c/o I don't feel good. It was warm and she had a fleece jacket on. Evaluated for s/s. No difficulty breathing. No redness at site. BP 110/60 P68 Reg and strong. At 4:15 Left feeling better. cold pack to site and 1 to take with her.									Y	11/08/2002	11/08/2002	0	NONE	PUB	PVT		NONE	NONE			1						1	Feeling abnormal	FLU3~SANOFI PASTEUR~U0931AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193491	11/19/2002	KY	40.0	40		F	11/14/2002	Flu vax 0.5 mg given left deltoid, 15 min later, pt c/o pain left shoulder, Red rash noted on back & shoulder, Emergency protocol followed. Benadryl 75 mg po per MD orders, Ice applied. Denied any Resp symptoms									Y	11/06/2002	11/06/2002	0	NONE	OTH	PUB	Appedix diet Meds	NONE	NKA			1						1	Injection site pain; Rash erythematous	FLU3~SANOFI PASTEUR~UO886AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193492	11/19/2002	OH	79.0	79		F		Swelling within 2 hour at site of injection. Ice applied swelling continued for 3 days. Swelling from site of injection to mid forearm. Red and warm to the touch. Ice and elevation continued. No systemic symptoms. Improved day 4. No symptoms by day 6.									Y	10/22/2002	10/22/2002	0		PUB	UNK		NONE	NONE			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U0966AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1351L~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193493	11/19/2002	OH	37.0			F	11/15/2002	Erythema and wheal. Localized reaction left upper arm.									Y				NONE	OTH	PVT	Zyprexa, Klonagin, Deparote	Local Cutaneous	Manic depression/ Anxiety disorder			1						1	Injection site erythema; Urticaria	FLU3~SANOFI PASTEUR~U0931AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193494	11/19/2002	NC	72.0	71		F	11/13/2002	Left arm local reaction at injection site. Not spreading. No systemic symptoms.									Y	10/23/2002	10/24/2002	1		PVT	PVT	NONE	NONE	NONE			1						1	Injection site reaction	FLU3~PFIZER\WYETH~4020016~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0193495	11/19/2002	GA	35.0	35		M	11/13/2002	Pt recovering from cold on day of vaccination. 5 days later kept feeling worse. Went to ER. Examined and given prescription for 2-pak. pt appears to be fully recovered. Puffiness of lymph node above left collar.				Y					Y	11/06/2002	11/13/2002	7		OTH	UNK	NONE	Recovering from cold	NONE			1						1	Lymphadenopathy; Malaise	FLU3~SANOFI PASTEUR~U0922AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193496	11/19/2002	FL	69.0	69		F	11/05/2002	Pt states she developed hives and a rash with pimples, about 3 1/2 hrs after flu shot. Went ot PMD 10/22 and received steroid shot without effect. Saw dermatologist 10/23 and given Clarinex and Medrol (unable to td. po. steroid). Saw allergist 10/24, given Allegra, Zantac, and steroid injection with relief.				Y					Y	10/21/2002	10/21/2002	0	Blood-no results yet	PUB	PUB	Zertec, Prevacid, Nasonex, Analapril, Evista, Valtrex, Lipitor, Detrol	Had been on flaggyl until 10/18/02	Numerous allergies, primarily environmental and to iodine.			1						1	Acne; Rash; Urticaria	FLU3~SANOFI PASTEUR~U0911BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193497	11/19/2002	UT	74.0	74		F		Pneumovax administered 11/07/2002. Right deltoid. Within 4 hours-local reaction of erythema, swelling proceeding distally- increasing over 72 hours. treated with Commenes, Benadryl, and Keflex.									Y	11/07/2002	11/07/2002	0	NONE	PVT	PVT	Levotoroid, Avandia	NONE	Gluophage			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U0981AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0358M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193498	11/19/2002	MI	21.0	21		F	11/14/2002	Fluvirin Vaccine - administered at 1045am left deltoid. 1230pm S/S left arm weak, nausea, diaphoresis, arm sore, SOB, fine rash at chest and pruritis and on neck. Presented back to clinic at 12:45				Y					Y	11/14/2002	11/14/2002	0		OTH	UNK	oral contraceptives, orthotricycline	NONE	NKA			1						1	Dyspnoea; Hyperhidrosis; Muscular weakness; Nausea; Rash pruritic	FLU3~EVANS VACCINES~E35822KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0193499	11/19/2002	NC	74.0	74		F	10/25/2002	Per pt states on 10/19/02 she woke up feeling ill and R arm hurting and red at injection site. Fever of 100.2 degrees either 10/19/02 or 10/20/02. Took Tylenol for fever, pt also says she too ? which did not relieved redness or swelling. Per phone report by pt. Pt states she was examined by MD 10/23/02 and was prescribed Cipro 500mg po bid x 10 days. Per call pt reports on 10/21/02 she called her PMD office and talked with his nurse. Pt says her swelling and redness of R arm had worsened and spread to axilla, within 1 inch of her elbow and to back and shoulder. Pt says she did not describe in detail to PMD nurse. Pt says she used ice pack on 10/21/02. On Wed. 10/23/02 pt reports she had not improved and she went to MD at 4pm and was diagnosed with cellulitis and was prescribed Cipro 500mg po bid x 10 days which she is taking. 10/25/02 approx 1-1:15pm pt called HD and talked to RN. Pt says swelling and discoloration of R arm is down today. Says discoloration is dark and diffuse. pt reports R upper arm (mid arm to shoulder) is sore and tender. Pt also reports tingling of her R hand. Pt advised to call PMD office and follow up with PMD regarding these symptoms. Pt voices desire to following with MD and understanding to do so. Pt advised that PHN is completing a vaccine adverse event report. 10/25/02 3:15 pm call to pt to complete question 17 and 19 on form. Pt says she did call MD office and talked with nurse. Pt says she was assured that she has not given enough time for antibiotic to work. Pt says she was advised to call office back on Monday and to go to hospital ER if needed over weekend.				Y					Y	10/18/2002	10/19/2002	1		PUB	PUB	Diovan, Premarin, Vioxx	NONE	Allergies-radioactive iodine, sulfa, Demaroe, has HBP		NC02108	1						1	Cellulitis; Injection site erythema; Injection site oedema; Injection site pain; Injection site reaction; Malaise; Paraesthesia; Pyrexia	FLU3~SANOFI PASTEUR~U0921FA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0111M~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193500	11/19/2002	TX	41.0	41		F	11/05/2002	Itch & rash over chest & back									Y	11/05/2002	11/05/2002	0		PUB	PVT		NONE				1						1	Rash pruritic	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193501	11/19/2002	NC	58.0	58		M	11/04/2002	Both arms 4x swollen, red, warmth at site if flu and pneumovax right left site				Y					Y	10/22/2002	10/24/2002	2		PVT	UNK		NONE	CABG- HL- HBP- COPD-Thyroid disease			1						1	Feeling hot; Injection site erythema; Injection site oedema	FLU3~PFIZER\WYETH~4020016~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1448K~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193502	11/19/2002	NC	54.0	54		F	11/04/2002	Left arm swollen and red 48 hrs after vaccination. Rx with Benadryl-recovered ~ 48 hrs.				Y					Y	10/29/2002	10/31/2002	2		PVT	UNK			PCN, Vibramycin, ceclor, COPD-anxiety, OA			1						1	Injection site erythema; Injection site oedema	FLU3~PFIZER\WYETH~4020016~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0193503	11/19/2002	CO	7.0	7		F	11/07/2002	Tips burning, lips swollen 4-5 mins after flu shot. Sent to ER Started on Predisone.				Y					Y	11/05/2002	11/05/2002	0	NONE	PVT	UNK	Maxair Inhaler	NONE	UNK			1						1	Face oedema; Skin burning sensation	FLU3~SANOFI PASTEUR~U0968AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193504	11/19/2002	CO	11.0	11		M	11/07/2002	Lips burning, & swollen, 45 mins post flu shot, Sent to ER , Started  Prednisone				Y					Y	11/05/2002	11/05/2002	0	NONE	PVT	UNK	Advair, Zyrtec	NONE	08/02 allergies, Tx with Zrytec			1						1	Skin burning sensation; Stomatitis; Swelling	FLU3~SANOFI PASTEUR~UO968AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193505	11/19/2002	CO	9.0	9		F	11/07/2002	Lips burning, lips swollen 45 mins post flu shot. Sent to ER and started on Prednisone.				Y					Y	11/05/2002	11/05/2002	0	NONE	PVT	UNK	Clarinex	NONE	UNK			1						1	Face oedema	FLU3~SANOFI PASTEUR~U0968AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193506	11/19/2002	OK	30.0	30		F	11/11/2002	Tingling with numbness R hand. Scheduled for EMG 11/11/02 and neuro consult with MRI of brain ordered.									N	10/15/2002	10/24/2002	9		PVT	PVT	progesterone, Inderal, Xanax, DCN	NONE	Anxiety, headaches, estrogen deficiency			1						1	Hypoaesthesia; Paraesthesia	FLU3~SANOFI PASTEUR~U0918AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193507	11/19/2002	WA	3.0	3		M	11/08/2002	Approx 1 hour after vaccine given developed red face, sneezing then sweating. Given benedryl. Now 2 hours later seems ok.									Y	11/08/2002	11/08/2002	0	has Aperts Syndrome	PVT	PUB	Augmentin 11/7/02 Finished, Tylenol 11/8/02	NONE	Aperts Syndrome only			1						1	Erythema; Hyperhidrosis; Sneezing	FLU3~SANOFI PASTEUR~U0968AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193508	11/19/2002	CO	53.0	53		F	11/08/2002	Vaccines 10/28/2002. By 10/30/2002 entire right upper arm swollen, very tender and 5cm red blotches to elbow. Injection site un remarkable, no adenopathy. 11/01/2002 transient bruises right upper arm, no redness, still very sore. Pneumovax given right arm 10/28/2002- returned 10/30/2002 on set with rash 10/28/2002 night.									Y	10/28/2002	10/28/2002	0	NL CBC 11/01/2002	PVT	PVT						1						1	Contusion; Injection site erythema; Injection site oedema; Tenderness	FLU3~SANOFI PASTEUR~40971AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0172M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193510	11/19/2002	NJ	53.0	53		F	11/09/2002	Woke up in the middle of night/early Thursday am-did not feel well. Nauseous. Index finger on hand of arm of injection site was blistered. Thursday/Friday still nauseous/diarrhea.									Y	11/06/2002	11/07/2002	1		MIL	OTH			PCN, sulfa, Benadryl, latex			1						1	Blister; Diarrhoea; Malaise; Nausea	FLU3~SANOFI PASTEUR~U0880AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193511	11/19/2002	ME	70.0	70		M		~18hr after vaccine: pain, swelling , stiffness, inflammation, and limited motion of left hand and wrist; D/C lipitor, hold allopurinol 2 weeks after vaccine: Sx persistent: restart allopurinol, continue indocin. 3 weeks after vaccine: Sx persistent; Levaquin 500mg 1QD.				Y					N	10/15/2002	10/16/2002	1		PVT	PVT		NONE	NONE			1						1	Joint range of motion decreased; Musculoskeletal stiffness; Pain; Swelling	FLU3~SANOFI PASTEUR~U0880AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193512	11/19/2002	OR	12.0	12		M	11/04/2002	Fever local reaction tender, redness 20 hours after pneumovax. Responded to Benadryl. Temp increase to 105 degrees.				Y					Y	10/31/2002	11/01/2002	1	NONE	PVT	PUB		NONE	Asthma, Suraur? Stenosis			1						1	Body temperature increased; Injection site erythema; Injection site pain; Pyrexia	FLU3~EVANS VACCINES~E31182GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0872M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193514	11/19/2002	IL	45.0	45		F	11/18/2002	Fever began Tues 11/5. Saw PCP 11/7. MD seen in ER 11/11. Dx flu and bronchitis with diff breathing, chest pain, joint pain. Tx-Biaxin, Benzotaten, Vicoclen.				Y					Y	11/04/2002	11/05/2002	1	CXR, blood work	OTH	PVT						1						1	Arthralgia; Bronchitis; Chest pain; Dyspnoea; Influenza; Pyrexia	FLU3~SANOFI PASTEUR~U0905FA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193515	11/19/2002	CA	9.0	9		F	11/18/2002	Rash on face, neck and ears									Y	11/04/2002	11/08/2002	4		UNK	UNK						1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193516	11/19/2002	CA	12.0	12		F	11/18/2002	rash on her arm									Y	11/04/2002	11/08/2002	4		UNK	UNK						1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193517	11/19/2002	OK	45.0	45		F	11/18/2002	10 minutes following injection began to have pain at site and tingling down arm. Aching pain has continued. no redness, edema at site									U	11/01/2002	11/01/2002	0	NONE	OTH	PUB	Thyroid meds	NONE	Migraines			1						1	Injection site oedema; Injection site pain; Pain; Paraesthesia	FLU3~PFIZER\WYETH~4020026~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0193518	11/19/2002	NY	39.0	39		F	11/18/2002	Received vaccine 11/07/02 @ 2 pm, 11/08- 98 AM noticed single skin eruption on face, Progressed to red, swollen lump @ injection site, Developed boil type lesions, upper back, back of neck				Y						11/07/2002	11/08/2002	1	NONE	OTH	OTH	NONE Routine Ibuprofen prn	NONE	NKA			1						1	Furuncle; Injection site erythema; Injection site mass; Skin ulcer	FLU3~PFIZER\WYETH~4020025~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0193522	11/19/2002	GA	51.0	50		F	11/18/2002	11/18/2002 States arm is less sore and decrease in redness. Decrease in joint pain and fever									Y	11/13/2002	11/15/2002	2		UNK	UNK		NONE	MVP, Environmental allergies			1						1	Arthralgia; Injection site erythema; Injection site pain; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U0933AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193523	11/19/2002	NJ	1.75	1	.9	M	11/04/2002	Mom called 11/01/02 to inform us that (her son) had an axillary temp of 101.5 with swelling of left arm from shoulder to elbow. Redness @ injection site only. Tender to touch. Mom gave Tylenol. Mom took (her son) to ER on 11/02/02. Dx of shoulder cellulitis ( prob. staph) and put on Keflex. Much improved today 11/04/02.				Y					Y	10/31/2002	11/01/2002	1	NONE	PUB	PUB	NONE	NONE	Asthma		200228	1						1	Cellulitis; Injection site erythema; Injection site pain; Injection site swelling; Pyrexia	DTAP~SMITHKLINE BEECHAM~525A2~3~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UO906BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~U0063~3~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0234M~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0193524	11/19/2002	GA	51.0	49		F	11/15/2002	11/15/2002 c/o pain, redness, and itching at injection site. injection site red around 4.5 x 2, hot, tight. temp 95.8										11/13/2001	11/15/2002	367		OTH	UNK		NONE	MVP, Environmental allergies			1						1	Feeling hot; Injection site erythema; Injection site pain; Injection site reaction; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~U0933AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193526	11/19/2002	NJ	75.0	75		F	10/25/2002	Pruritis diffusely.									Y	10/11/2002	10/14/2002	3	NONE	PVT	PVT			Diabetes type II			1						1	Pruritus ani	FLU3~SANOFI PASTEUR~U0877AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193527	11/19/2002	PA	45.0	45		M	11/08/2002	Severe pain in left arm in lymphnodes under arm (arm pit) and at elbow swelling and redness, heat. Still being treated.				Y					N	11/01/2002	11/03/2002	2		OTH	OTH		NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth; Lymphadenopathy	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0193528	11/19/2002	WI	50.0	50		M	11/08/2002	Severe chills, fever, body aches, syncope, sharp pain, intermittent L side of back, fatigue.									U	11/06/2002	11/07/2002	1		PVT	OTH	ASA, Tikosyn, Zocor, Lysine, HCT Z, Indocin, Lisnosix		URI			1						1	Chills; Fatigue; Pain; Pyrexia; Syncope	FLU3~SANOFI PASTEUR~U0931AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0735M~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U0818AA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0193529	11/19/2002	IL	18.0	18		F	11/11/2002	Within 25 mins of receiving vaccine, face flushed and generalized itching appeared. No breathing difficulties at any time. Flushing lasted 6 hrs, itching lasted 2 days. Meds: took 50mg Benadryl 3 hrs after onset of sx. No further medication or rx necessary.									Y	10/29/2002	10/29/2002	0	NONE	PVT	PVT		NONE	Ceclor			1						1	Flushing; Pruritus	FLU3~SANOFI PASTEUR~U0906BA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193548	11/19/2002	MN	1.5	1	.5	F	11/14/2002	Right anterior thigh swelling of entire thigh to nearly double the normal size per parent report. Area warm to touch. Anterior portion hard. Parents to watch and have evaluated for any exacerbation. Note: Afebrile, circulation good, playful.									Y	11/11/2002	11/12/2002	1	None	PVT	PVT	Topical Bactroban for impetigo	None	Hives x2 of unknown etiology.			1						1	Feeling hot; Injection site induration; Injection site swelling	DTAP~SMITHKLINE BEECHAM~574A2~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U0954AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SMITHKLINE BEECHAM~5358A2~3~IM~LL~HEP B (ENGERIX-B)~1|HIBV~SANOFI PASTEUR~UA753AA~4~IM~RL~HIB (ACTHIB)~1	USA		Influenza
0193552	11/19/2002	UT	1.3	1	.3	M	11/13/2002	Redness, induration, swelling of injection site. Developed about 36 hours after injection.									Y	11/11/2002	11/12/2002	1	None	PVT	PVT	None	None	None			1						1	Injection site erythema; Injection site induration; Injection site swelling	DTAP~SANOFI PASTEUR~U0585DA~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U0988AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UA737AA~4~IM~LL~HIB (ACTHIB)~1	USA		Influenza
0193555	11/19/2002	LA	41.0	41		F	10/20/2002	Right arm sore that evening. Left arm OK. Continued to become more swollen and tender- fever 102.6 last night (Tues. night into Wed.) Today painful to lift arm, sore under arm and into neck. Looks pale and in pain. 10/30/2002 7pm Pt had an appt with MD so mom went with her and asked MD to look at her arm. She did and advised PT she was developing a cellulitis 2 degree to one of the vaccines- Gave her a Rx for an antibiotic. 11/06/2002 PC to P- Improving although her right arm is still sore, but not tender like it was. She continued to run fever of 102 degrees until Fri. Was able to see her PMD on Fri. He concurred that she had a local reaction to a vaccine and cellulitis. As she was on an antibiotic he did not advise any additional treatment. He thought the vaccine that created the problem was Td. The antibiotic she took was Omnicef- She continued to run a low grade temperature during the early am and late pm until Sun. and has been afrebile since.				Y					Y	10/28/2002	10/28/2002	0	NONE	PUB	PUB	B12 shots Hormone	NONE			LA021102	1						1	Cellulitis; Injection site oedema; Injection site pain; Injection site reaction; Pallor; Pyrexia	FLU3~SANOFI PASTEUR~U0943AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~469133~1~IM~LA~PNEUMO (PNU-IMUNE)~1|TD~SANOFI PASTEUR~U0520AA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0193572	11/19/2002	MA	31.0	31		F	11/07/2002	Right arm swelling, redness at shot area. Numbness of right and little finger. Infection at shot site and entire arm.				Y					Y	11/03/2002	11/04/2002	1		MIL	MIL		NONE	NONE			1						1	Hypoaesthesia; Injection site erythema; Injection site infection; Injection site oedema	FLU3~SANOFI PASTEUR~U0983AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0814AA~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0193583	11/19/2002	MD	42.0	42		F	11/14/2002	Two days after pt received several vaccines, she presented with a 10cm x 7cm edematous erythematous welt posterior R arm.									U	11/12/2002	11/14/2002	2	NONE	MIL	MIL	PPD	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Urticaria	FLU3~SANOFI PASTEUR~U0983AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0086M~1~IM~~HEP A (VAQTA)~1|TD~SANOFI PASTEUR~U0518AA~4~IM~LA~TD ADSORBED (NO BRAND NAME)~1|TYP~SANOFI PASTEUR~U0704~UNK~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|YF~SANOFI PASTEUR~UB231AA~2~IM~RA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0193584	11/19/2002	PA	40.0	40		F	11/19/2002	Fore arms were very itchy - both right and left Large hives on right cheek -facial and left jawline									Y	11/05/2002	11/07/2002	2		UNK	PUB	BCP, Claritin D, Advil, vitamins	N/A	Pyridium			1						1	Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193694	11/19/2002	OH	45.0	45		F	11/19/2002	Receive influenza vaccine on 11/15/02. 24 hours later, she developed total body hives. Saw physician 48 hours later and given steroid shot in same arm as flu shot. Developed severe immediate pain and passed out. Upon awakening, had intense arm pain (still does today), heavy extremities, was very hot/perspiring and was fatigued.				Y					U	11/15/2002	11/16/2002	1	None	PUB	PUB	Zyrtec	None	Allergic to molds			1						1	Fatigue; Hyperhidrosis; Pain; Sensation of heaviness; Syncope; Urticaria	FLU3~SANOFI PASTEUR~UO933AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193695	11/19/2002	GA	21.0	21		F	11/19/2002	Difficulty breathing,  I felt like my throat was closing up, very fast heart beat, hives, shaking, and dizziness. Immediately, contacted my physcian and she advised me to come to her office.  She determined that I was having an allergic reaction to the flu shot.  She adminstered shots to counteract the symptons and give me to prescriptions to have filled. They are:  Prednisone 10mg and Diphenhydramin HCL 50 100.				Y					Y	11/19/2002	11/19/2002	0		UNK	PVT						1						1	Dizziness; Dyspnoea; Heart rate increased; Hypersensitivity; Tremor; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0193605	11/20/2002	MS		72		M	11/13/2002	On 11/9/02 at 8PM, patient was unsteady on feet, had no pain or discomfort. On 11/10/02 3AM complained of muscle weakness, unsteady gait. At 10:30AM complained of unable to walk. Seen by MD on 11/10, blood work order. On 11/12 seen by neurologist and was admitted to hospital.					Y				Y	11/09/2002	11/09/2002	0		OTH	PVT	Maxzide; Prevacid; Med Plus; Centrum; Baby ASA; Tums, Vitamin C; Vitamin E; Cogentin; Tylenol; Risperdal; Buspar; Elocon	None	NKA, GI Distress, Circulation disoder, Schizophrenia, Rash on ankles			1						1	Abasia; Gait disturbance; Guillain-Barre syndrome; Muscular weakness	FLU3~EVANS VACCINES~E31912HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0193606	11/20/2002	AR	44.0	44		F	11/14/2002					Y	Y	1			Y	11/04/2002	11/04/2002	0	None	OTH	PUB	Tylenol	Recovering from Kidney Infection	Recent Kidney Infection			1						1	Unevaluable event	FLU3~PFIZER\WYETH~4020008~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0193610	11/20/2002	CO	64.0	64		M	11/14/2002	Abd pain, hospitalized for bowel obstruct. Symptoms included nausea, vomiting, diarrhea.					Y	8			Y	10/31/2002	11/02/2002	2		PUB	UNK			Minor scarring on appendix and large intestine.			1						1	Abdominal pain; Diarrhoea; Intestinal obstruction; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U0919AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0193611	11/20/2002	PA	74.0	74		F	11/13/2002	Received influenza vaccine and received pneumovax vaccine on 11/6/02. Complained of redness in right arm on 11/7/02. Redness in right arm, with pain to elbow on 11/7/02. The discharge summary states cellulitis, and edema.					Y	4			Y	11/06/2002	11/07/2002	1	Physical exam 11/7/02 -  erythema left arm to elbow.	PVT	PVT		None	No allergies, HTN, Hypercholesterolemia, ASCVD (aorta)			1						1	Cellulitis; Erythema; Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~0880AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0165M~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0193618	11/20/2002		72.0	72		F	11/19/2002	Extreme chill for about 12 hours. Then felt extremely hot for about 24 hours. Whole body ached. Shakiness for bout 3 days.									Y	11/09/2002	11/09/2002	0		UNK	UNK						1						1	Chills; Hot flush; Pain; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0193619	11/20/2002	OH	43.0	43		M	11/11/2002	Woke up 2 days later with very sore muscles, fatigue, sore arm. No headache, sore throat, fever or GI symptoms.				Y						11/01/2002	11/04/2002	3	None	OTH	UNK						1						1	Fatigue; Myalgia; Pain	FLU3~SANOFI PASTEUR~U0922AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193620	11/20/2002	WA	54.0	54		M	11/09/2002	3-5 mins after injection I became dizzy, a feeling of weakness accompanied this. The affect lasted from early am through the day and night. Disappearing by next morning or I would have called my family doctor.									Y	10/24/2002	10/24/2002	0	NONE	PUB	PVT	Darvacet, Inwaltr, Procaroid XL, Nitrobid, potassium, oral prednizone	NONE	?, cardiac arrhythmia, HBP, chronic sinusitis			1						1	Asthenia; Dizziness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193621	11/20/2002	WA	48.0	48		F	11/12/2002	Right shoulder: erythema, induration, tenderness (6cmx3cm)									Y	11/08/2002	11/08/2002	0	None	PVT	OTH	HCTZ, Insulin, Paxil, Clemastine, Glyburide, Cimridine	None		Erythema/Induration~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Injection site erythema; Injection site induration; Tenderness	FLU3~PFIZER\WYETH~4020019~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0193622	11/20/2002	CA	48.0	48		M	11/08/2002	Received the vaccine at 1:00 and began feeling ill about an hour later. Began having diarrhea around 5pm which lasted, with slight nausea (no vomiting) through the night until 6am. Felt achy and slight feverish. No painor discomfort at the injection site. States he feels this way when his sugar is low. It was 95 11/7 pm. Ha shad low food but feeling better pm. 11/8/02 no diarrhea or nausea and joint achiness. Feels pretty good now.				Y					Y	11/07/2002	11/07/2002	0	NONE	PUB	PUB	Incodin and Tylenol, Glucophage, Zocor, Lotensin, Plentil	NONE	Diabetes, hiatus hernia, high cholesteral, high BP, hx o three strokes, intermittent episodes of diarrhea.			1						1	Diarrhoea; Malaise; Nausea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U0919AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193623	11/20/2002	CT	72.0	71		F	11/13/2002	Lethargy, weakness, tremor				Y					U	10/03/2002				PVT	PVT			Sinusitis, Anitibiotics			1						1	Asthenia; Lethargy; Tremor	FLUX~UNKNOWN MANUFACTURER~E31212GA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0193624	11/20/2002	MI	4.0	4		M	11/08/2002	Hive like welts around immunization site appeared 10-15min after injection. Also hives started spreading down arm. Doctor informed & 1.5 tsp Benadryl given per doctor.										11/08/2002	11/08/2002	0		PVT	PVT	NONE	Cough	Fish			1						1	Urticaria	FLU3~SANOFI PASTEUR~UO950AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193625	11/20/2002	MI	2.0	2	.5	F	11/08/2002	Fever started 11/7/02. Rash on abdomen, back and legs.										11/05/2002	11/07/2002	2		PVT	PVT	Albuterol, Pulmicort	URI, RAD				1						1	Pyrexia; Rash	FLU3~SANOFI PASTEUR~U0950AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193626	11/20/2002	NY	83.0	83		F	11/15/2002	C/O soreness and swelling and pain in L arm using ice and Advil prn, sometimes with good effect, sometimes not.									U	11/11/2002	11/12/2002	1		PVT	UNK		Slight cold	NKA			1						1	Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U0879AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193627	11/20/2002	MN	20.0	20		F	11/13/2002	L sided focal seizure (1st time) in same side as vaccine given 3 1/2 hrs post vaccine.				Y					Y	11/07/2002	11/07/2002	0	Nl CT scan, nl MRI, EEG pending	PUB	PVT	Ovcon 35	NONE	NONE			1						1	Convulsion	FLU3~SANOFI PASTEUR~U0926BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193628	11/20/2002	CA	19.0	19		M	11/08/2002	Redness, Edema to right arm, Tricep area, prescribed.  Dicloxacillin 500 mg Q 6 hrs.									N	11/04/2002	11/06/2002	2		MIL	MIL			Allergic to sulfa			1						1	Injection site erythema; Oedema peripheral	FLU3~PFIZER\WYETH~4020032~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEPA~MERCK & CO. INC.~0408M~2~IM~~HEP A (VAQTA)~1|TTOX~SANOFI PASTEUR~U0841444~1~SC~~TETANUS TOXOID (NO BRAND NAME)~1|TYP~SANOFI PASTEUR~U1073~1~SC~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0193629	11/20/2002	UT	27.0	27		F	11/11/2002	Deltoid swollen-red moved to area under arm and into rib area. MD seen/allergic reaction.				Y					Y	11/07/2002	11/07/2002	0		PUB	PVT						1						1	Erythema; Hypersensitivity; Injection site erythema; Injection site oedema; Oedema	FLU3~SANOFI PASTEUR~U0920AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193630	11/20/2002	CA	41.0	40		F	11/14/2002	Patient complained of rash and itching on left and right arm. Also a pale rash on chest area. Complaints of dry throat with difficulty swallowing. Instructed to notify personal physician. Seen in doctor's office. Patient reports that she was given Dexamethasone IM. Symptoms subsided 30 minutes to 1 hour after injection.				Y					Y	11/07/2002	11/07/2002	0		UNK	UNK		None	Allergic to spider bites and bee stings.			1						1	Dry throat; Dysphagia; Pruritus; Rash	FLU3~EVANS VACCINES~E33152GA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0193631	11/20/2002	WI	31.0	31		F	11/13/2002	Pt given flu immunization approximately 10 mins after giving-she stated she was having some tightness in her throat like a lump. Also some difficulty breathing. States has asthma at 305pm she was given Benadryl .25mg IM LD and was taken to EHS for observation. She also gave herself 2 puffs of inhalers.				Y					Y	11/13/2002	11/13/2002	0	NONE	PVT	OTH	Albuteral		Asthma			1						1	Dyspnoea; Throat tightness	FLU3~EVANS VACCINES~E34102HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0193632	11/20/2002	MO	58.0	58		M	11/14/2002	Rash bil forearms, slightly raised small bumps, no itching but rash feels hot to touch. Also has same rash on left side of neck.				Y					U	11/13/2002	11/13/2002	0		PUB	PVT		NONE	Taking accutane for 3 months prior for oily skin		MO2002039	1						1	Rash	FLU3~PFIZER\WYETH~4020022~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0193633	11/20/2002	NJ	65.0	65		F	12/01/2002	On Wednesday, had itching between fingers. On Thursday hands were itching. Didn't realize anything was wrong until 7pm that day. By 715pm, left side of tongue swelled up. Hives and welts over 20-25% of body.				Y					N	11/12/2002	11/13/2002	1		UNK	UNK	NONE	NONE	NONE			1						1	Pruritus; Tongue oedema; Urticaria	FLU3~SANOFI PASTEUR~U0909AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193634	11/20/2002	MD	20.0	20		M	11/14/2002	Reported not feeling well at midnight 11/9/02 before going to bed; reports achiness, headaches, and nasal congestion, which began earlier in the evening. Awoke at 05:00 with itching and hives. The hives were present to bilateral arms, bilateral thighs, lower abdomen and left flank area. No respiratory distress noted. Treated with IM Benadryl 50mg x1 to left gluteus. Then continued with PO Benadryl for 2 days per package directions. A decrease in redness and itching was not after IM Benadryl administration.									Y	11/07/2002	11/09/2002	2	None	OTH	OTH	Advair, Albuterol	None	Sulfa allergy, environmental allergies			1						1	Headache; Malaise; Nasal congestion; Pain; Pruritus; Urticaria	FLU3~EVANS VACCINES~E33092HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0193635	11/20/2002	IL	69.0	69		F	11/12/2002	Pt received pneumo 11/9/02. On 11/10/02 noc pt had swelling with bruising from R shoulder to R elbow-went to hospital-given Levaquin 500mg qd x 6d.				Y					Y	11/09/2002	11/10/2002	1		PUB	PUB	NONE		HTN, chronic HA's d/t meningone, allergy to pcn.			1						1	Contusion; Injection site oedema	FLU3~SANOFI PASTEUR~U0932AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0358M~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193636	11/20/2002	FL	48.0	48		M	11/12/2002	At 48 hrs pain in left arm to hand. Tingling pain in neck and face. Blurring vision in left eye. Memory confusion. Paralysis in left arm and left side of face. Saw doctor after 6 days of getting worse and was given urgent appt. to see neurologist. Diagnosed as nerve damage. Must be alert to possible progression of paralysis. No treatment available.				Y					N	10/23/2002	10/25/2002	2		MIL	OTH		NONE	Hepatitis C			1						1	Confusional state; Injection site pain; Memory impairment; Nerve injury; Paraesthesia; Paralysis; Vision blurred	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193637	11/20/2002	NY	75.0	75		F	11/06/2002	Left arm red, warm, edema from deltoid to wrist.									Y	10/14/2002	10/15/2002	1	None	PVT	PVT		None	None			1						1	Erythema; Feeling hot; Oedema	FLU3~EVANS VACCINES~E33362GA~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1050L~2~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193638	11/20/2002	IA	51.0	51		F	11/14/2002	Dizziness, sweating, chills, vomiting. T 98.6, HR 64, R 20.									U	11/14/2002	11/14/2002	0		OTH	PVT		NONE	Allergic to bee stings			1						1	Chills; Dizziness; Hyperhidrosis; Vomiting	FLU3~SANOFI PASTEUR~U0903AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193639	11/20/2002	CA	62.0	62		M	11/01/2002	Swelling in lower right forearm, warm/hot to the touch, red, no tenderness. Swelling started in right tricep area with redness.				Y					U	10/28/2002	10/29/2002	1		MIL	UNK	Lopressor, Lotensin, Aspirin, Niacin, Zocor, Prednisone, Plaqenil, Multivitamin, Saw Palmento, Milk THistle, Coenzyme, Omega-3, Glucosamine, Ultra Energy, Garlic	None	HBP, Rheumatoid Arthritis, Emphysema			1						1	Erythema; Feeling hot; Swelling	FLU3~SANOFI PASTEUR~U0880AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0111M~1~SC~RA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U0816AA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0193640	11/20/2002	FL	24.0	24		F	11/06/2002	On Sunday, 11/3 stated with dizziness, lighthead throughout the day, nausea. On 11/5 Tuesday again with the same symptoms. Could not stand, shortness of breath, dizzy and nausea.				Y					Y	11/02/2002				MIL	MIL						1						1	Dizziness; Dyspnoea; Nausea	FLUX~UNKNOWN MANUFACTURER~4020032~5~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~SANOFI PASTEUR~UB185AB~2~~~MENINGOCOCCAL (MENOMUNE)~1|TYP~SANOFI PASTEUR~U0704~2~PO~MO~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0193641	11/20/2002	GA	43.0	43		M	11/13/2002	Flu vaccine received at 15:00 at my place of work. No reaction noted at time. At about 22:00, I noticed a rash/pustules around neck/upper shoulder. Pustules are small with white fluid inside. About 100 to 150. Took 25md Diphenhydramine; no effect.									U	11/12/2002	11/12/2002	0		OTH	PVT		Recovering from stomach flu previous week	Hay fever			1						1	Rash pustular	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193642	11/20/2002	UT	21.0	22		F	11/11/2002	Swollen, red, raised area 4 inch diameter.				Y					Y	11/07/2002	11/07/2002	0		PUB	UNK						1						1	Rash erythematous; Swelling	FLU3~SANOFI PASTEUR~U0920AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193643	11/20/2002	KS	51.0	51		F	10/23/2002	10/18/02 flu vaccine administered. 10/19/02 site red, itchy and hot at injection site. Site was marked around area of swelling redness. 10/21/02 swelling s/s all gone.									Y	10/18/2002	10/19/2002	1	NONE	PUB	PVT	Prempro, Fosamax, Paxil, Prevacid	NONE	Keflex	Erythema~Influenza (Seasonal) (no brand name)~1~49.00~In Patient		1						1	Injection site erythema; Injection site hypersensitivity; Injection site oedema; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U0882AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193644	11/20/2002	MN	55.0	55		M	11/14/2002	Patient stats vision is blurry and getting worse, decreased appetite, feels tired, pulse elevated.									N	10/25/2002	10/26/2002	1	NONE	OTH	PVT	Lisinopril, etodolac, propanolol	UNK	UNK			1						1	Decreased appetite; Fatigue; Heart rate increased; Vision blurred	FLU3~SANOFI PASTEUR~U0938AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193646	11/20/2002	TX	20.0	20		F	11/08/2002	7cm are of erytema, warmth, mild itching around injection site at left deltoid 48 hours after injection.									Y	11/06/2002	11/07/2002	1		PUB	UNK	NONE	NONE	NONE			1						1	Injection site erythema; Injection site hypersensitivity; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U0903AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193647	11/20/2002	PA	58.0	58		F	11/13/2002	Stiffness in hips, knee, and generalized body aches; felt like arthritis and frozen joints in hips and knees. Patient walked three miles at 1 PM. She normally walks 3 miles a day. Symptoms resolved 11/7/02.									Y	11/04/2002	11/05/2002	1	None	OTH	OTH	Calcium	None	Osteopenia			1						1	Joint stiffness; Musculoskeletal stiffness; Pain	FLU3~SANOFI PASTEUR~U0922AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193648	11/20/2002	TX	37.0	37		F	11/13/2002	Received flu shot about 8am. One hour later, R hand shaking, tingling, sharp pain at site. Went home from work, called MD on the way home-he told her that her ?. Take Motrin 3x/day, ice over R arm. She was bettter on Sunday. 11/10 except for bruised arm.									Y	11/07/2002	11/07/2002	0	nONE	PUB	PVT		NONE				1						1	Contusion; Injection site pain; Paraesthesia; Tremor	FLU3~SANOFI PASTEUR~U0936FA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193649	11/20/2002	WV	45.0	45		F	11/13/2002	On 11/06/2002 received pneumonia shot in left arm and flu vaccine in the right arm. Later that evening, patient complained of right arm aching. On 11/7/02 she did not feel good all day and on 11/8/02 she broke out in bright, red hives on her legs, chest, lower back and neck. She saw a doctor and was given an injection of Kenalog. She was also given methylprednisolone and hydroxyzine to take.									N	11/06/2002	11/06/2002	0		OTH	OTH		None	Tetanus vaccine and penicillin			1						1	Malaise; Pain; Urticaria	FLU3~EVANS VACCINES~E35732HA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0710M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193703	11/20/2002	FL	44.0	44		M	10/15/2002	Within minutes of receiving a flu shot, the pt developed tingling, flushedhands, palpitations, dyspnea and chest and arm pressure. He had been fasting the entire day before and moring of the shot. Brought to the observation room and given oxygen. EKG showed tall pisked p-wave. Pt also had a murmur he denied having in the past or abd EKG-referred to ER. Seen in local ER and referred to cardiologist. EKG at our facility was with tall pisked p-wave-pt had a murmur.				Y					N	10/08/2002	10/08/2002	0	EKG-tall pisked p-wave	OTH	OTH	Allegra	NONE	NONE			1						1	Cardiac valve disease; Chest pain; Dyspnoea; Electrocardiogram abnormal; Hot flush; Palpitations; Paraesthesia	FLU3~SANOFI PASTEUR~U0874AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193704	11/20/2002	MA	2.0	2	.1	M	09/27/2002	Within 1 hr stuffy nose, edema of eyelids and marked edema of loose skin of shaft of penis, Benadryl.				Y					Y	09/27/2002	09/27/2002	0		PVT	UNK		R otitis media	Tretralogy of fallot	~Varicella (Varivax)~~1.80~In Patient		1						1	Eyelid oedema; Nasal congestion; Oedema	FLU3~SANOFI PASTEUR~U0879AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193711	11/20/2002	MD	54.0	54		F	11/12/2002	Initially injection site soreness and quickly led to swelling to elbow on L side.									U	11/04/2002	11/04/2002	0		PUB	UNK	Glucophage, Lipitor, Vasotec, Zyrtec, Ambien	NONE	Diabetes, hypertension, dysplimidemia			1						1	Injection site oedema; Injection site pain	FLU3~EVANS VACCINES~E33672HA~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~UNKNOWN MANUFACTURER~0165M~1~~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0193712	11/20/2002	IL	90.0	90		F	11/06/2002	Right arm pneumonia vaccine left arm influenza vaccine given. Next day right arm had bruise and bruising continued down the arm. Saw pt on 11/4/02 at another clinic and talked with client and referred to Dr. Had bleeding time completed at Dr office and was taken off Coumadine for three days.				Y					Y	10/31/2002	11/01/2002	1		PUB	PUB	Coumadin		Liver cancer		IL02062	1						1	Contusion	FLU3~SANOFI PASTEUR~U0924GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1353L~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193714	11/20/2002	OH	78.0	78		F	11/04/2002	Reported 11/4/02 approximately 3-4 hrs after injection pt had chills for 2 hrs, then became warm, pain throughout back and weakness. Pt states she had a racing heart beat about 7 hrs after the shot. States by morning 11/1/02 at 8am heart rate was better. Pt discussed with nurse at MD's office on 11/1/02 her symptoms. Advised to contact MD office or go to ER if symptoms persist. MD office notified by RN.									Y	10/31/2002	10/31/2002	0	NONE	PUB	PUB	Trandate, Zocor, Coumadin,Vasotec	NONE	CVA 1999, hypertension, high cholesterol	Chills, weakness, racing heart beat~Influenza (Seasonal) (no brand name)~1~73.00~In Patient		1						1	Asthenia; Back pain; Chills; Feeling hot; Heart rate increased	FLU3~SANOFI PASTEUR~U0938AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193715	11/20/2002	CA		59		F	11/06/2002	11/6/02 client c/o upper and lower lip swelling, achey all over, c/o clearing throat more than usual c/o face swelling. Denies shortness of breath, no difficulty breathing. Client is slightly improving as time passes.									Y	11/05/2002	11/05/2002	0	NONE	PUB	UNK	NONE	NONE	NONE			1						1	Face oedema; Pain	FLU3~SANOFI PASTEUR~U0919AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193716	11/20/2002	MD	60.0	60		U		Welt and red rash.									U	11/18/2002	11/19/2002	1		UNK	UNK						1						1	Erythema; Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193717	11/20/2002	MI	36.0	36		F	11/20/2002	Right arm red, swollen, painful, hives at injection site.				Y					Y	11/13/2002	11/13/2002	0		PUB	PVT						1						1	Injection site erythema; Oedema; Pain; Urticaria	FLU3~SANOFI PASTEUR~U0937AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193718	11/20/2002	VA	39.0	39		F	11/20/2002	Received Influenza vaccine at approx 9:00AM.  Indicated approx 9:00PM (12 hours post vaccination) had severe itching of arms, greater on right than left and itching of upper abdomen.  Vaccine administered in left deltoid.  Self treated with OTC Bendadryl and symptoms resolved.									Y	10/15/2002	10/15/2002	0		PVT	PVT	None	NONE	Asthma, Allergic to bird feathers			1						1	Pruritus	FLU3~EVANS VACCINES~E 34102HA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0193720	11/21/2002	TX	42.0	42		F	11/01/2002	Patient received flu vaccine and a Rocephin injection after office visit. She developed an anaphylactic reaction and subsequently respiratory failure. Despite resuscitation attempts, patient died. Anaphylactic reaction.	Y	11/01/2002							N	11/01/2002	11/01/2002	0	NONE	PVT	PVT	Rocephin TGM IM, Albuterol, Atrovent, xalatian, Advair, Seravent, Lasix, Ambien, Iron, Zanaflex, Lexapro, Elavil, Respirdol, Potassium, Cipro, Floxin, Penicillin, Levaquin, Adhesive Tape, Naprosyn, Timoptic	Asthma	Nail-patella syndrome, glaucoma, hematuria, hep C, personaltiy disorder, bipolar, narcotic dependence, asthma, hypercholesterolemia, chronic pain.			1						1	Anaphylactic reaction; Respiratory failure	FLU3~SANOFI PASTEUR~U0982AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0193723	11/21/2002	MI	57.0	57		F	11/14/2002	Patient presented with complaints of weakness and tingling in arms and legs. She became progressively weak and required intubation. She was diagnosed with GBS. Intubated, ended up trached, required Pheresis. Developed pneumonia, anemia. No definate etiology for the GBS was noted, except that patient reports having a flu shot in October--not sure exact date. The MICU team felt the GBS was due to the flu shot.			Y						Y	10/01/2002	10/28/2002	27	Normal CPK, BUN, SOR, Elestight, Catz, MGT2, Po4, WHL	UNK	UNK						1						1	Anaemia; Asthenia; Guillain-Barre syndrome; Paraesthesia; Pneumonia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0193724	11/21/2002	TX	42.0			M	11/15/2002	Patient developed paralysis of legs and cervical spine swelling as appreciated on an MRI 1 week after receiving the flu vaccine.   The discharge summary states actue demyelinated encephalomylitis, transverse myelitis.					Y			Y	N	11/01/2002	11/08/2002	7	MRI done on 11/8 shows moderate broad-based disc bulging at C6-7 that is diffuse	UNK	UNK	NONE		NONE			1						1	Anaemia; Apnoea; Arthralgia; Encephalitis; Headache; Laboratory test abnormal; Malaise; Myalgia; Myelitis transverse; Paralysis; Pleural effusion; Swelling	FLU3~SANOFI PASTEUR~U0958AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0193731	11/21/2002	OK	45.0	45		F	11/12/2002	Both elbows painful, tender to palpation, red, rashy areas over both ante? areas left knee tender.				Y					Y	11/08/2002	11/08/2002	0		OTH	OTH	NONE					1						1	Erythema; Injection site pain; Rash	FLU3~SANOFI PASTEUR~U0913AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193732	11/21/2002	OH	68.0	68		F		Received influenza and pneumonia vaccine on 10-25-02 at 9:30am, pneumonia given in right shoulder; influenza in left shoulder. 10-27-02 in morning, scattered red itchy pimples observed. 10-31-02 entire body covered with red itchy rash. Doctor was notified. Rx: methypremisolone 4mg PO dose pak ordered. 21 tabs was taken over a period of six days with good effect.				Y					Y	10/25/2002	10/27/2002	2	NONE	PUB	PUB	Glucophage 500mg twice daily, taprol 25mg daily	NONE	Diabetes Type 2, High Cholesterol, High blood pressure; allergic to asprin, penicillin, sugar drugs.			1						1	Pruritus; Rash erythematous	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0193734	11/21/2002	CO	49.0	49		F	11/06/2002	Tuesday pm reaction size of grapefruit swollen, hard and red. Wednesday, redness and swelling to elbow, Thursday/Friday underlying bruise. Some hoarsness of lungs Real lose cough. Used ice and benedryl. Reaction in right arm.									Y	10/29/2002	10/29/2002	0	Refused to see doctor or notify VNA. School nurse called VNA	PUB	PVT	Benedryl po	NONE	weak lungs OCC wheezing		C002-041	1						1	Dysphonia; Injection site erythema; Injection site oedema	FLU3~PFIZER\WYETH~4020028~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0709M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193735	11/21/2002	AZ	62.0	64		F	11/20/2002	Eggsized rash the day after injection. Resolved on its own in a few days.									Y	11/13/2002				PVT	UNK		NONE	Hyper cholesterol,  eczema, Osteoppathy			1						1	Rash	FLU3~PFIZER\WYETH~4020036~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0193736	11/21/2002	AZ	30.0	30		F	11/20/2002	Raised, red, egg-sized area on arm. Resolved in a few days.									Y	10/31/2002	10/31/2002	0		PVT	UNK		NONE				1						1	Injection site erythema; Injection site swelling	FLU3~PFIZER\WYETH~4020036~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0193737	11/21/2002	NC	50.0	50		M	11/20/2002	Light dizziness and nausea. Reaction to wearing glasses.									N	10/26/2002	10/28/2002	2		UNK	UNK						1						1	Dizziness; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193738	11/21/2002	NJ	62.0	62		M	11/15/2002	Pt called insisting that he had reaction to flu vaccine. Sx include nausea starting in evening and con't throughout the night. Improved somewhat by am of 11/07/2002									Y	11/06/2002	11/06/2002	0		PUB	PVT						1						1	Nausea	FLU3~SANOFI PASTEUR~U0921BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193739	11/21/2002	NC	28.0	28		F	11/08/2002	Starting feeling extremely nauseated 20 minutes after receiving vaccine. My right arm(lower) became itchy and red about 9:45am. I went to see Nurse to ask if symptoms were normal at 10am. I began vomiting and getting dizzy while talking the nurse. 10:05 am I was driven by friend to ER at 10:30am. Was seen by emergency room physician at 11am. My temperature was 99.15, dizzy, nauseated, rash on lower right arm and extreme need to urinate while at Hospital. I was given a shot in my left hip to counter act the Flu vaccine. I was observed for about 2-3 hours. I became clear minded and some what normal after 3 hours. I was given a prescription and order for bed rest for 24hours. After 24hours I felt back to my normal self, except continued bowel irritation and a cyst found(small) on my left shoulder where shot was given, and frequent need to go to the restroom to urinate.				Y					Y	11/01/2002	11/01/2002	0		OTH	PVT					02109	1						1	Cyst; Dizziness; Erythema; Nausea; Pollakiuria; Pruritus; Pyrexia; Vomiting	FLU3~EVANS VACCINES~E35452HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0193740	11/21/2002	MD				M	11/13/2002	Bell's Palsy- Diagnosed Treatment Steriods. Abated in 2 months. Symptoms- left sided facial paralysis resulting in left side drooling, inability to smile symmetrically and difficulty chewing									Y		02/27/2002			MIL	UNK	NONE	NONE	Gout, hypertension, tasticular cancer	H/A, joint pain~Anthrax (Biothrax)~3~0.00~In Patient		1						1	Drooling; Facial palsy; Hemiplegia; Hypokinesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193741	11/21/2002	CA	45.0	45		F	11/08/2002	Note- did not eat breakfast 1. Symptoms: difficulty breathing, fats heart beat, dizziness, extremely weak, sweaty palms, shaking 2. With in 5 minutes of injection (reaction occurred) 3. Sat with legs up and drank juice/ ate crackers. took apprx. 10 hours (began to feel better apprx. 09:00 pm Went home rested had lots of fluids.									Y	11/07/2002	11/07/2002	0		OTH	UNK	Synthroid- did not take that day	NONE	PCN/ Sulfa  Menopause: bouts of dizziness			1						1	Dizziness; Dyspnoea; Heart rate increased; Hyperhidrosis; Muscular weakness; Tremor	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193742	11/21/2002	PA	29.0	29		M	11/19/2002	Within 48 hrs of receiving flu vaccine, pt develped sharp chest pain,non-productive cough. No fever/chills/SOB. CXR-neg. Dx. ?				Y					U	11/15/2002	11/17/2002	2	CXR-neg	PUB	OTH			PCN allergy			1						1	Chest pain; Cough	FLU3~EVANS VACCINES~E37182KA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0193743	11/21/2002	WV	44.0	44		F	11/14/2002	Weakness 24 hours. Body shakes with standing. Fatigue 10 days after. Chills alternating with hot flashes. Increase BM. Early onset menstraul by 1 week. right roof mouth and right tongue feels burned									Y	11/04/2002	11/05/2002	1	NONE	PUB	PUB	NONE	NONE	NONE		WV0215	1						1	Chills; Fatigue; Hot flush; Intestinal ischaemia; Menstruation irregular; Muscular weakness; Paraesthesia oral; Tremor	FLU3~EVANS VACCINES~E34722HA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0193744	11/21/2002	MO	49.0	49		F	11/18/2002	Pt presented with cough/wheezing. The next day post receiving flu vaccine was treated with Albuterol neb/prednisone.				Y					Y	11/13/2002	11/14/2002	1	NONE	PVT	UNK		Pt had slight sore throat				1						1	Cough; Wheezing	FLU3~SANOFI PASTEUR~U0955AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193745	11/21/2002	NJ	51.0	51		F	10/28/2002	Sore arm 1 hour after shot- pain became worse went to ER on 10/21/2002. X-rays done. Feel nerve irratation- given Naprasyn and muscle relaxant (Flexeril). Also seen by MD group, Rx for Bextra. Going back to gruop, Wed 10/31/2002. States still has knot at injection. 10/28/2002 At 09:30 am, we received a telephone call from pt stating her left arm became very sore with radiating pain to her shoulder immediately after receiving her flu shot on Thursday, October 17, 2002. She states that she applied ice to her upper arm, and later heaat. However, paon became worse and she went to the emergency room at JFK on Monday, October 21,2002. She was given muscle relaxants and the doctor felt she developed a pinched nerve, advised her to see her private medical doctor. The pt states sh eonly has a cardiologist whom she has spoken to and he advised her to go to group. She was seen by MD, who also felt her spine was in spasm. She will be seeing another doctor in the group tomorrow. Pt states she has been out of work since 10/17/2002 as she could not use her left arm. i informed her that I did not feel the flu injection would cause a pinched nerve. Advised her to keep her appointment at the group and follow their instructions. I stated that I would speak to the nurse supervisor and call her back. RN.  10/28/2002 returned call to pt, she states that she didn't call sooner then 10/28/2002 as she felt the pain would go away. However, she has a knot in arm and shoulder is still painful. She states the arm never became red or swollen. Pt si an Orthrodontist Assistant and attending school. She states she hasn't been able to go to work and does not have any more sick time. Concerned she would not be able to complete her course, as it requires using both hands. She does have health insurance. Advised her to call the health depatment after her doctor appointment on Wednesday 10/30/2002. RN 10/30/2002 Telephone call to pt, states she was seen by MD, pain management physician, at group. Pt states MD stated injection caused problem with nerve in upper arm and pain in shoulder is due to muscle inflammation secondary to injection. MD ordered physical therapy for 3 weeks, 2-3 times a week. She will start therapy on Friday, November 1,2002 with . Pt stated she is going to try to return to work this afternoon. She questioned if she would be compensated finacially for money she was required to spend due to this incident. I advised her I would speak to my supervisor and get back to her. Also requested she call the health department to let us know how she was feeling after therapy. Per acknowlegdement letter- All missing information is already on form.				Y					N	10/17/2002	10/17/2002	0		PUB	PUB	Folic Acid	NONE	Mitral Valve Prolapse		200231	1						1	Injection site mass; Injection site pain; Muscle spasms; Neuralgia	FLU3~SANOFI PASTEUR~U0911BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193746	11/21/2002	NJ	65.0	65		F	11/13/2002	Chills beginning approximately 3 hrs after immunization. Temperature unknown. Developed sore throat during night. Throat still sore on 11/13/02, but no chills. Still with chills and head cold as of 11/15/02.									N	11/12/2002	11/12/2002	0	NONE	PUB	PUB	NONE	NONE			NJ200229	1						1	Chills; Feeling cold; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U0949AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193747	11/21/2002	OK	22.0	21		F	11/14/2002	Employee was given flu shot. Arm where injection given became very red/raised area. She did not complain of pain. SOB, etc. Slight rash did appear.									Y	11/14/2002	11/14/2002	0	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site swelling; Rash	FLU3~EVANS VACCINES~E33402HA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0193748	11/21/2002	MD	57.0	57		F	11/16/2002	Within 6-7 hrs, I developed a violent diarrhea, cramps, headache, muscle pain, joint pain and a 4 hour elevation in temperature. My MD saw me Monday. He believed that my reaction came either from the flu shot or a dormant virus which activated due to lowered immune response due to the shot.				Y					Y	10/19/2002	10/19/2002	0		OTH	PVT	Zestril, Chrduva, Crestin, PrilosecClaritiv	NONE	Ceclor, codeine, some antibiotics, sulfa, tobacco smoke, dust, mold	Reaction unspecified~Influenza (Seasonal) (no brand name)~~27.00~Patient		1						1	Abdominal pain; Arthralgia; Body temperature increased; Diarrhoea; Headache; Myalgia	FLU3~EVANS VACCINES~E33482HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0193749	11/21/2002	CA	47.0	47		F	10/22/2002	3 hours after injection, felt burning. Next am, had swelling and redness approx. 2 diameter which was present for a week.									Y	10/22/2002	10/22/2002	0		PVT	PVT		NONE	Iodine, latex, shellfish, bees	Burning, swelling, red inj site (larger area)~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Injection site erythema; Injection site inflammation; Injection site oedema	FLU3~SANOFI PASTEUR~U0968AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193750	11/21/2002	OR	57.0	57		F	11/15/2002	Reddened/painful arm followed by the hand and arm going numb. ER Rx'd antibiotics, Benadryl and ASA.				Y					Y	11/04/2002	11/05/2002	1	UNK	OTH	PVT	Claritin, Serzone, premarin, Flovent, Albuterol	NONE	Vicodin, asthma, allergic rhinitis			1						1	Hypoaesthesia; Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U0951AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0735M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193751	11/21/2002	NC	74.0	74		F	11/15/2002	Severe hives, itching and burning over whole body 4 hrs after flu shot. Took Benadryl 50mg every 6 hrs continued to get worse. Big red splotches all over. On 4th day, went to urgent care center, got injection of Kenilog and Keflex 80mg. Rx for prednisone and Keflex.				Y					Y	11/05/2002	11/05/2002	0		PVT	PVT	Glucophage, Amaryl, Mavik		Diabetes type II, hypertension			1						1	Pruritus; Rash maculo-papular; Urticaria	FLU3~SANOFI PASTEUR~U0971AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193768	11/21/2002	PA	5.0	5		M	11/21/2002	Urticaria on back and site of injection 36 hours after injection				Y					Y	11/19/2002	11/21/2002	2	n/a	PVT	PUB	Zyrtec, Pulmicort, Albuterol	none	asthma			1						1	Urticaria	FLU3~SANOFI PASTEUR~110936FA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193769	11/21/2002	CT	43.0	43		F	11/21/2002	About 10-15 minutes after the vaccine was administered, itchiness began at the site of the injection.  Over the next hour and a half the itching spread down the left arm and to the entire upper body.  The intensity of the itching also increased.  Hives developed.  MD examined me, checked my pulse and BP.  Both were normal.  He gave me a 12.5 mg tablet of Benadryl.  About 1 hour and 10 minutes later, the itching started to decrease.  About 3 hours later the itching started to increase again.  I took 2 Benadryl Allergy/Sinus Headache tablets (12.5 mg Diphenhydramine Hydrochloride,30 mg Pseudoephedrine Hydrochloride, 500mg Acetaminophen).  The itching competely stopped about 3 hours later. The follow up states, I forgot to include in my summary that the physician who gave me the vaccine and responded/monitored my reactin recommended that I not take the flu vaccine again.									Y	11/08/2002	11/08/2002	0	N/A	UNK	UNK	Glucophage, 500mg bid Clarinex, 5 mg qd (a.m.) Sudafed, 30mg, (q 6hrs prn) Multivitamin	None	Medical conditions: -Mild Diabetes Mellitus/Glucose Intolerance -Small Thyroid Goiter -Polycystic Ovary Syndrome Medication Allergies: -Morphine (Wheal at injection site) -Clindamycin (Itchy, raised hives) -Secanol (Rash) Severe Adverse Reactions to Medications: -Regalin (Severe Muscle dystonias) -Talwin (Dizziness, weakness, sudden onset severe vomiting for 4 hours) Other allergies: -PABA (Itchy raised hives) -Pineapple (Large, severe mouth ulcers) -Dust, molds, mildew, eucalyptus, various pollens (Hayfever type reaction)			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0944AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193770	11/21/2002	AL	26.0	26		M	11/21/2002	the pt received an injection in his right arm.  he began to notice increasing pain and swelling of his right arm and chest muscles on the right side.  he presented to our emergency room and was found to have significant muscle swelling and tenderness of his right arm and right anterior chest wall.  he was also noted to be in rhabdomyolysis with ck's greater than 15,000.					Y	8			Y	10/25/2002	10/27/2002	2	as above,  the manufacturer of the vaccine was wyeth	UNK	UNK	none	none	none			1						1	Oedema; Pain; Tenderness	FLUX~UNKNOWN MANUFACTURER~v0932aa~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0193771	11/21/2002	MI	2.0	2	.0	M	11/21/2002	Pt died 4 days after administration of vaccine	Y	10/21/2002							N	10/17/2002	10/21/2002	4		PVT	UNK	1.  Claritin syrup 5 mg once a day. 2.  Zantac 9 mg twice a day. 3.  Reglan 1 mg 3 times a day. 4.  Multivitamin 1 mL 1 times per day. 5.  Iron 90 mg 3 times per day. 6.  Pulmicort 0.5 mg twice a day. 7.  Inhaled tobramycin 300 mg twi	1.  Hypoxic-ischemic encephalopathy. 2.  Seizure disorder. 3.  Cerebral palsy. 4.  Recurrent aspiration. 5.  Diffuse lymphad	1.  Hypoxic-ischemic encephalopathy. 2.  Seizure disorder. 3.  Cerebral palsy. 4.  Recurrent aspiration. 5.  Diffuse lymphadenopathy and hepatosplenomegaly of unknown etiology. 7.  Chronic urticaria. 8.  Failure to thrive, improvement after G-tube placement.			1						1	Congenital anomaly; Pneumonia; Unevaluable event	FLU3~SANOFI PASTEUR~U0911aa~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0193842	11/21/2002	UT	25.0	25		F	11/21/2002	Breathing difficulties, wheezing, coughing, tightness of chest for 3 hours after immunization, until medical help was sought.   Redness, heat and swelling at injection sight for 96 hours after immunization.				Y					Y	11/18/2002	11/18/2002	0		PVT	PVT						1						1	Chest discomfort; Cough; Dyspnoea; Erythema; Feeling hot; Oedema; Wheezing	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0193386	11/22/2002	MN	26.0	26		F	11/19/2002	It was reported that a 26 year old female received Fluzone SV 2002-2003 USP (lot number U0924EA) administered IM in the left deltoid. Approximately 30 seconds after injection, the patient developed seizure activity, stopped breathing, and became unresponsive and cyanotic. Rescue breathing administered and the carotid pulse was present. The patient began Cheyne-Stokes breathing and gradually became responsive to verbal stimuli approximately 3-4 minutes after the injection. The patient recovered.  Reported on 03/04/2003: From follow-up (follow-up #1) received from manufacturer on 02/24/2003, it was reported that the patient had a history of migraines.  No further information is provided. A 15-day follow up report received 9/12/2003 adds: From additional info received on 09/02/2003 from the reporter, no additional info is available. No further info is anticipated, this case is considered closed.			Y	Y					Y	11/12/2002	11/12/2002	0	NONE	OTH	OTH	Allegra, Propanolol	None	History of migraines		U200201021	1						2	Coma; Convulsion; Respiratory disorder; Apnoea; Coma; Convulsion; Cyanosis	FLU3~SANOFI PASTEUR~U0924EA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0924EA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening	Influenza
0193782	11/22/2002	NY	64.0	64		F	11/19/2002	Information has been received from a physician concerning his wife, a 64 year old white female with hay fever and a pcn allergy who on 10/18/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 641532/1353L). Concomitant therapy included Lipitor, Niaspan, Volmax, Mavik, Allegra, influenza virus vaccine and Foltx. Within six hours after the administration of her first dose of pneumococcal vaccine 23 polyvalent. On 10/18/02, the pt experienced pain and her right upper arm had swollen two to three times its size. She also develped erythema and heat with immobility of her right arm. The pt felt warm and may have had a low grade fever but measurements were not taken. The physician also noted that a blood test following the injection indicated that the pt's serum creatine kinase (CPK) was elevated to 512. Subsequently on 10/18/02, the pt was treated with rofecoxib 50mg tablet, 50mg once a day for two days. Thereafter, the dose of rofecoxib was decreased to 25mg once a day along with Vicodin. On 10/21/02, a complete blood count, SMA-20, serum creatine kinase test, urinalysis and a serum immunoglobulin E test were all within normal limits. On 10/22/02, after four days of oral therapy, a heating pad four times a day and elevation of the right arm, the pt recovered from the pain, swelling, erythema, and heat with immobility of her right arm as she had remobilization of her right arm and the swelling was 80% down. The pt sought unspecified medical attention. The pain, swelling, erythema, and heat with immobility of her arm were considered to be disabling for 96 hours and other important emdical events (OMIC) by the physician. Additional info is not expected.				Y				Y	Y	10/18/2002			Blood test following the injection indicated that the pt's serum creatine kinase (CPK) was elevated to 512. On 10/21/02, a complete blood count, SMA-20, serum creatine kinase test, urinalysis and a serum immunoglobulin E test were all within normal limits.	OTH	OTH	Volmax, Lipitor, Foltx, Allegra, Niaspan, Mavik		Hay fever, pcn allergy		WAES0210USA02195	1						1	Blood creatine phosphokinase increased; Body temperature increased; Hypokinesia; Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1353L~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0193788	11/22/2002	IL	7.0	7		M	11/15/2002	Rec'd vaccine Sunday @ 11:30AM, Reaction Tuesday @ 19:30, Arms started trembling,increased temperature,BP, HR,RR, Notified MD, 911 called , taken to hospital, Seizure continus, Rectal temp at hosp - 104.6@ 9:45PM. Motrin liquid & Tylenol suppository given, X-ray,cultures done - all neg				Y	Y	3			Y	11/10/2002	11/12/2002	2	X-ray 11/12 negative; Blood cultures negative	OTH	PVT	Naftin, Ritalin, Tegretal, Aldectone, Lasix, Metadate CD		PCN allergy; lactose intolerance; seizure disorder; congential heart disease; prematurity			1						1	Convulsion; Heart rate increased; Hypertension; Respiratory rate increased; Tremor	FLU3~EVANS VACCINES~E31842GA~2~IM~GM~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0193793	11/22/2002	AR	17.0	17		M	11/15/2002	Patient go pale, severely hypotensive and bradycardia (84/40 & 36) soon after the vaccine. History of egg allery as an infant. Now he is fine and eats eggs all time				Y					Y	11/15/2002	11/15/2002	0		PVT	PUB	NONE	NONE	egg allergy as an infant, syp juvenile diabetes mellitis	passed out~Vaccine not specified (no brand name)~~0.00~In Patient		1						1	Bradycardia; Hypertension	FLU3~PFIZER\WYETH~4020036~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~MERCK & CO. INC.~0216M~1~IM~LA~HEP B (RECOMBIVAX HB)~1	USA	Emergency room visit	Influenza
0193794	11/22/2002		60.0			F		aliterature report was receivced on 11/11/92, concerning a 60 year old female patient who experienced relapse of severe plasti anemic afterreceiving fluvirin in 11, 1998. the patient's illness was proceede by an influenza-like condition . the patient was diagnosed as having severe aplastic anemia in january,1996 when she was presenterd to the hospital with profound pancytopenia (Hb 3.9 g/dl. WBC 2.2X 10-9.L, Neutrophil count.  Follow up on 02/05/2003: A follow up report was received from a health care professional indicating that the 6 year old female vaccinee experienced a relapse of aplastic amnesia 3 months after receiving Fluvirin on 10/14/1998.  The vaccinee was first diagnosed in 01/1996 with aplastic anaemia and want into remission in October 1998.  The vaccinee had had a previous Fluvirin vaccination on 10/20/1997.  Concomitant medication reported included cyclosporine which she had been taking due to transplant for 3 months prior to the relapse.  On 01/06/1999 the vaccinee experienced a relapse of aplastic anaemia.  The reporter indicated that the vaccinee seemed to have recovered by July 2000.  There was insufficient information to determine the reporter's causality assessment.									Y	11/01/1998	11/01/1998	0	Hemoglobin: 13.7 g/dl; Neutrophil count: 3.8x10^9/L; Platelet count: 175x10^9/L; White Blood Count: 5.9x10^9/L;	UNK	UNK	Concomitant drugs were not reported		severe aplastic anemia 1996		PJP200200755	1						1	Anaemia; Influenza like illness; Laboratory test abnormal; Pancytopenia; Platelet count increased	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0193795	11/22/2002	PA	45.0	45		F	11/09/2002	Flu vaccine given between 9-10 am. Apprx. 12 noon, RN noted pt in cafeteria c/o pain in injection area. About 1pm pt came to clinic area c/o itchy eyes, swollen red. Generalized body urticaria- no hives visible. Sent to health office									Y	11/07/2002	11/07/2002	0		PUB	PUB	Lamisil 250mg/ 1day, Accupuril 20mg/1day	NONE	High blood pressure			1						1	Eye irritation; Eye swelling; Injection site pain; Ocular hyperaemia; Urticaria	FLU3~PFIZER\WYETH~4020022~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0193796	11/22/2002	PA	46.0	46		M	11/18/2002	Patient telephoned on 11/13/02 10am to describe twitching of the right eye at 9pm on 11/12/02. At 4am on 11/13/02 he awoke with numbness of the right side of the face. He stated that it feels like it is full of novocaine.				Y					N	11/12/2002	11/13/2002	1		PUB	PVT						1						1	Hypoaesthesia; Muscle twitching	FLU3~PFIZER\WYETH~4020022~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0111M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193797	11/22/2002	NH	78.0	78		F	11/18/2002	Hives									Y	11/03/2002	11/06/2002	3		PUB	OTH	Paxil	NONE	has celia sprue			1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193798	11/22/2002	MA	32.0	32		F	11/08/2002	c/o Pain in left shoulder radiating up neck. 11/12- Saw private physician who diagnosed neck sprain from ? gym equipment.									Y	10/30/2002				PUB	PUB	NONE	NONE	Chronic Fatigue Syndrome		MA0206	1						1	Neck pain; Pain	FLU3~SANOFI PASTEUR~U0879AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193799	11/22/2002	SC	51.0	51		F	11/13/2002	1hr after receiving injection patient experience itching at site. Site was white and swelling at the size of a 50c with red circle around that. White area with edematous tissue grew larger to cover 3/4 upper arm. Took benedryl po.									Y	11/04/2002	11/04/2002	0		PVT	OTH	Prednisone 2-pak, Entex, FemHrt, Xioxx	URI	Asthma			1						1	Hypersensitivity; Injection site oedema; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U0909AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1352L~2~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193800	11/22/2002	OH	62.0	62		F	11/15/2002	Redness and swelling injection site about 4-5 cm area erythema									Y	11/01/2002	11/12/2002	11		PVT	PVT	Synthroid .175 mg,Nortryptyline 50mg, Diovan 160mg, Inderel LA 160mg, Lasix 20mg, Fioicet, Ibuprofen 800 mg, Luinine 260mg, Allegra 60mg, Initex 25g, Norvon 5 g, Litrel 5/20mg,  Antiovt 25g	NONE	HTN, hypothyroid with surgical migraines			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U0937AA~4~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193801	11/22/2002	NC	37.0	37		F	11/18/2002	Patient developed N/V diarrhea during night after vaccine. Next morning had rigors, chills, sever pain in right arm, myalgia, headache. All symptoms continued with worsening pain, eyrethema, induration of arm (extended down einterie length of arm by 11/17), and fever to 103 despite continued NSA ID, benedryle, claritin rx. Cough developed 11/18 started on Augmentin for cough. Cellulitis. Arm simply improving by 11/18, but cough worsened, started on zithromax. Not yet recovered at time form completed.				Y					N	11/13/2002	11/14/2002	1		OTH	PVT	NONE		uritcaria to unknown agents in last 2 years	~Measles + Mumps + Rubella (no brand name)~~0.00~In Sibling|~DTP (no brand name)~~0.00~In Sibling		1						1	Cellulitis; Chills; Cough; Erythema; Myalgia; Pain; Pyrexia	FLU3~EVANS VACCINES~E35472HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1050L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193802	11/22/2002	NY	78.0	78		M	11/16/2002	Severe pain and swelling of arm above left elbow. This lasted about 3 days. Lessened general energy, poor appetite, occassional dizziness. This lasted 5 to 6 days. Gradual returned pre- vaccination status in 7 days.									Y	11/07/2002	11/07/2002	0	NONE	PUB	OTH	Atenalol, Lovastatin	NONE	NONE			1						1	Anorexia; Dizziness; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~407C030~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~6709M~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193803	11/22/2002	CA	13.0	14		M	11/15/2002	10-15 mins after flu shot, pt in car with father and brother who report he c/o numbness in one arm, then LOC, gagging resps, Tonic/Clonic generalized movements approximately 30 secs. Pt amnesic for events.				Y					Y	11/01/2002	11/01/2002	0	NONE of note, Father reports backflow into syringe during injection.	PVT	PVT	Albuterol, Flovent, Amoxicillin	bilateral otitis	Asthma			1						1	Convulsion; Hypoaesthesia; Loss of consciousness; Retching	FLU3~PFIZER\WYETH~402004~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0193805	11/22/2002	MD	36.0	36		M	11/18/2002	Pt c/o open sore on left arm at injection site. Pt stated it was itching this am. Pt adds he started feeling bad friday the 15th in the evening and was in bed all weekend. Pt reaction was 4 x 5 mm open sore, 10 x 10 cm in redness. CTL									Y	11/15/2002	11/17/2002	2		MIL	MIL						1						1	Contusion; Feeling abnormal; Injection site erythema; Injection site hypersensitivity; Injection site reaction; Pruritus	FLU3~PFIZER\WYETH~4020040~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0193806	11/22/2002	MD	65.0	65		F	10/28/2002	Received pneumoccal vaccine in right deltoid 10/25/2002 about 10:30am. Apprx.  at 3:30pm ,she experienced severe pain in her right arm extending down to her fingers to the point she could not use her arm. She was taken Tylenol- Ibuprofen- applied moist heat. On 10/28/2002 when she reported it, pain had improved somewhat although she still had significant pain from her deltoid muscle to her elbow with limited use of her arm. No numbness or tingling. No bruising or redness at the sight. No fever. Gradually improved over a two week period.									Y	10/25/2002	10/25/2002	0		OTH	UNK	Synthroid .008mg, Clarinex 5mg, Triam + HCTZ 75/50 mg	NONE	Hayfever, HTN, Thyroid condition			1						1	Hypokinesia; Injection site pain	FLU3~PFIZER\WYETH~4020022~4~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0358M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193807	11/22/2002	IL				F	11/15/2002	Phoned me at 09:37am- c/o swollen arms, hot denied breathing problem, denied hives, was working at Census Bureau- Nurse came in and gave flu shots on Tues. 11/12/2002.										11/12/2002	11/15/2002	3		OTH	OTH						1						1	Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U0933AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193835	11/22/2002	OH	3.0	3		M	11/21/2002	Shortly after receiving vaccine, the patient was not acting like himself. Next morning, he vomited 4 times, had 2 loose stools, increased fatigue. Took to physician's office; was found to be obtunded. Transferred to ER where he had decreased mental status and was unable to protect his airway and was intubated, stabilized and transferred to PICU. Patient received 10day supply of Rocephin, 1 week of cithromax. Received FFP and cyro for discharge.			Y	Y	Y	11	Y		Y	11/07/2002	11/07/2002	0	11/8/02 blood cx-positive for bacilus, head CT-neg x 2, MRI neg, EEG-diffuse encephalopathy.	PVT	PUB	Amoxicillin	None	NKDA, sickle cell			1						1	Diarrhoea; Encephalopathy; Fatigue; Mental impairment; Vomiting	FLU3~SANOFI PASTEUR~U0925AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0193848	11/22/2002	MD	18.0	18		F	11/18/2002	c/o itching 25 mins after Influenza vaccine given. Itching at left deltoid. No rash or breathing difficulty. Influenza vaccine given at 3:30pm. Benadryl 50mg po at 3:45. Vital signs checked and monitored by RN. Discharged from medical dept at 4:45pm. Ice packed applied left deltoid. Pusle Ox checked at 100 % B/P and heart rate and respiratory normal.									Y	11/15/2002	11/15/2002	0		UNK	OTH	Albutrol Inhaler	NONE	Asthma			1						1	Injection site hypersensitivity; Pruritus	FLU3~PFIZER\WYETH~4020024~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0193849	11/22/2002	AZ	49.0	49		F	11/22/2002	Intial localized golf-ball sized swelling in left arm with generalized flu-like symptoms. Lingering diffuse pain and muscle spasms in left arm, shoulder, underarm area breast and pectorals. Sentfor mammogram/utrasound with negative results. I am worried and in pain. Please respond.									N	11/05/2002	11/06/2002	1		UNK	UNK						1						1	Influenza like illness; Injection site oedema; Injection site pain; Muscle spasms	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0193851	11/22/2002	CA	1.1	1	.1	M	11/22/2002	Patient received the vaccine at about 5:30PM. Within 10 minutes he changed his behavior and became fussy ( which is uncommon for him). By 6:15 his checks began to become beat read followed by his ears, watery eyes, red chest, stomach, arms, legs, followed by hives covering his body. He began to kick and scream w/ irritaton. He also had a fever of 102. He could not walk due to dizziness and agitaton. At this point I knew he was having a reaction and gave him his medication of Hydarax ( dose 1.875). It took apx 40 after giving the Hydarax that he became calm, redness, hives and fever went away. The symptoms did not continue through tha night. I do believe had I not had the medication needed on hand i would of had to take patient to the local emergancy room or if the medication given did not work.									Y	11/21/2002				PVT	UNK		NONE	Milk Protein, allergy; Food Allergy, Hole Milk allergy;			1						1	Abasia; Abnormal behaviour; Agitation; Dizziness; Erythema; Irritability; Lacrimation increased; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~1~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~1~~~VARICELLA (NO BRAND NAME)~1	USA		Influenza
0193881	11/22/2002	KY	38.0	38		F	11/22/2002	Pt received Influenza vaccine at 8:30AM. began itching @ 9AM. Notified RN @ 10:15AM. Benadryl 50mg IM @ 10:18. C/O itching, rash around neck, dry mouth, Itching in throat. No difficulty breathing at this time  Pulse 60, Resp. 18. patient pale. Repeat VS Pulse 100, Resp 24 @ 10:25AM. EMS on scene at 10:27AM. Transported patient to ER.   Taken to Emergency Room by EMS.				Y					Y	11/21/2002	11/22/2002	1		PUB	PUB		None known	Allergy to Cipro			1						1	Dry mouth; Pruritus; Rash	FLU3~SANOFI PASTEUR~U0946aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193883	11/24/2002	CA	57.0	54		F	11/24/2002	UPPER ARM IS HARD & SWOLLEN, TENDER TO THE TOUCH, LIMITED RANGE OF MOTION WHEN RAISING ARM.MEDICAL XRAY SHOWED NOTHING. PT TAKING IBUPROFEN 600MG TID & IS RESPONDING.				Y					U	10/08/2002	11/01/2002	24		UNK	PVT	GLUCOPHAGE, GLUCOTROL XL, ACTOS,LIPITOR, SYNTHROID, BABY ASA		DIABETIC			1						1	Joint range of motion decreased; Oedema; Tenderness	FLU3~EVANS VACCINES~E33472HA~6~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0193860	11/25/2002	NC	86.0	86		F	11/15/2002	Erythema and puffiness of site surrounding injection on left shoulder, mild itching at lower arm.									N	11/13/2002	11/13/2002	0	NONE	PVT	PVT	Prelone, Eczor, Plavix, Actonel	NONE	allergy to keflex, had conditions hyperlipidemia, GERD, osteoarthritis			1						1	Injection site erythema; Pruritus	FLU3~SANOFI PASTEUR~U0872AB~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0541M~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193862	11/25/2002	NY	71.0	71		F	11/08/2002	Pain in right arm beginning about two hours after receiving the vaccine. The pneumonia vaccine was given in the right arm. Reports limited range of motion. Four fingers of right hand cool to touch.				Y					Y	11/08/2002	11/08/2002	0		PUB	UNK		NONE	NONE			1						1	Joint range of motion decreased; Pain	FLU3~PFIZER\WYETH~4020026~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0923L~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193863	11/25/2002	WI	54.0	54		F		Influenza vaccine given 11/11/02. Patient developed total body urticaria for which she was evaluated on 11/19/02. Hives were resolving well. Canadryl oly was needed. She developed total body urticaria. It cleared with benadryl.										11/11/2002	11/12/2002	1		PVT	PVT	Sinermet, Soma,		Demerol, Sinermet, Soma, Protonix,Prempro, Zantac,Trazadone,Prevacid, Wellcovorin SR, Plavix, Qxycodone, Duragine Patch, Oxycontin			1						1	Urticaria	FLU3~SANOFI PASTEUR~U0888AA   exp 0~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193873	11/25/2002	KS	67.0	67		F	11/22/2002	11:30am began to feel like had needles in her tongue. Head down while sitting in waiting room. Took to exam table to lay down. B/P 190/96, 180/100. 11:48am sitting on edge of exam table. Reports feeling better-generally and with hot tongue. Face and neck flushed. 11:50am c/o 200/110. Pt to ER via WIC 12:15pm. In ER ex nurse B/P 200/96.				Y					Y	11/14/2002	11/14/2002	0	NONE	PUB	PUB	Benadryl, Premarin, Inderal, Nixcin, multi vit, Zinc, Glyceramine	NONE	Numerous pain pills, antibiotics, nutr sweet, HTN, high cholesterol, sinus problems			1						1	Blood pressure increased; Glossitis; Glossodynia; Hot flush	FLU3~SANOFI PASTEUR~U0943AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193874	11/25/2002	MD	65.0	65		F	11/22/2002	Call rec'd at 9:30am 11/22/02. pain from rt side of neck to wrist (incl. upper knot at wrist, rt side. No redness. Had pneumonia that in rt arm delt. In 11/21/02 allergic reaction, lymph glands in chest and under arm Rx Benadryl q 4 hrs. To return if no improvment by tom. 11/23/02.									U	11/21/2002	11/21/2002	0		PUB	UNK	NONE	NONE	Allergy to Alevo			1						1	Hypersensitivity; Pain; Skin nodule	FLU3~SANOFI PASTEUR~U0921EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0541M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193877	11/25/2002	CA	54.0	54		F	11/22/2002	Hives on the inside of elbow and arms.				Y					N	11/13/2002	11/14/2002	1		UNK	UNK						1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0193884	11/25/2002	CO	19.0	19		F	11/25/2002	Received Influenza Vaccine 10/17/2002.  Seen by PCP 10/22/02 with c/o severe HA.  DX with migraine, treated with Compazine IV.  Later referred to Neurologist for F/U secondary to continued HA.  MRI and spinal tap done.  Per pt., dx with adverse reaction to Influenza vaccine.  Seen in ED 11/09/2002 for c/o HA and backache after spinal tap done 11/07/2002. Demerol/Phenergan given IM.				Y					N	10/17/2002	10/22/2002	5	MRI - unknown results S. Tap CSF Panel:Appearance normal, WBC:0, RBC:0, T Prot.:38, Glucose:57  CNS/MS Panel: Olig Bands: 0, MBP: 0.1, IGG Index: 0.50, Albumin: 17.10, IGG CSF: 2.37, Alb. Serum: 3620, IGG Serum 1010, IGG/Alb.Serum CSF: 0.14, IGG/Albumin Ser.: 0.3, VDRL CSF: nonreactive	PVT	PVT	Loestrin, Tagamet		Allergy to Sulfa, Morbidly Obese,			1						1	Back pain; Headache	FLU3~SANOFI PASTEUR~UO905FA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193885	11/25/2002	MA	52.0	52		F	11/25/2002	Extreme Redness, swelling and Pain at site also with heart palpatations for four days following shot. Dr.'s office visit said site was infected and antibiotic is being taken for 10 days.				Y					Y	11/19/2002	11/19/2002	0		PUB	UNK		none	allergy codeine , penicillin			1						1	Erythema; Infection; Oedema; Pain; Palpitations	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0194072	11/25/2002	MD	29.0	29		M	11/25/2002	Mild headache Restlessness/irritability (treatment not required at this time).									Y	11/25/2002	11/25/2002	0		UNK	UNK		Common cold				1						1	Headache; Irritability; Restlessness	FLUX~UNKNOWN MANUFACTURER~E33922HA~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193115	11/26/2002	NY	60.0	60		M	11/26/2002	arm swollen 2 hours after the injection, arm ached, next day he fell down 10 stairs, went to ER because of the fall, he did hurt the same arm. ER MD stated he had a cellulitis of the arm from the injection. treated with Levaquin X 7 days									Y	11/06/2002	11/06/2002	0		PUB	PUB	zoloft, lipitor	none	diabetes			1						2	Feeling hot; Injection site erythema; Injection site swelling; Cellulitis; Oedema; Pain	FLU3~EVANS VACCINES~E33402HA~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0541M~UNK~~LA~PNEUMO (PNEUMOVAX)~1|FLU3~EVANS VACCINES~E33402HA~6~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~0541M~1~SC~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0193889	11/26/2002	NJ	11.0	10		F	11/21/2002	It was reported that an 11 year old female received Fluzone SV '2002-'2003 (lot number U0958AA), administered on 11/13/02. The next day on (11/14/02), the pt developed redness, swelling, and pain at the injection site. She presented to the ER on 11/15/02 and was admitted hospital. She was discharged from the hospital on 11/16/02 with the diagnosis of cellulitis. It was not reported whether the pt recovered from the event.   Reported on 03/04/2003: From follow-up #1 correspondence received at Aventis Pasteur Inc. On 02/24/2003, it was reported that the 10-year-old patient was hospitalized for one day.  No other vaccines were given within 4 weeks.  Patient has a history of asthma and seasonal allergies.  Concomitant medications include albuterol nebulizer, advair, zyrtec and singulair.  Patient had no illnesses at the time of vaccination. A 15-day follow up report received 12/16/2003 adds: On 12/08/2003, the hospital discharge summary and office notes were received. The lot # of the product was reported as U0969AA, not U0958AA, as initially reported. The discharge diagnosis was cellulitis vs. allergic reaction. She was prescribed Augmentin 5cc 3 times daily for 10 days and was advised to follow-up with her family physician. No other info was provided. No further info is anticipated, this case is considered closed.				Y	Y	1			Y	11/13/2002	11/14/2002	1	Any diagnostic studies done at the hospital.	OTH	OTH	Albuterol nebulizer, Advair, Zyrtec, Singulair	NONE	Asthma, seasonal allergies.		U200201023	1						1	Cellulitis; Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U0969AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0193901	11/26/2002	GA	75.0	75		F	11/20/2002	Complained of soreness and large reddened area left arm(sq). State had rapid heartbeat and low blood pressure Saturday 11-16-02. State arm looks much better Monday 11-18-02 but still hurts some and patient feels like she getting chills. Encouraged to see MD. Saw Dr. and he said it look like an infection and gave Augmentin 1000mg po BID v 6 days.				Y					Y	11/15/2002	11/15/2002	0	NONE	PUB	PUB	Pravachol QD, Tomoachen BID, Synthroid QD, Allegra BID, Diltiazem	NONE	This lady has had right mastectomy and is unable to get injection on right arm; was allergy shots 12 years ago		GA02125	1						1	Chills; Heart rate increased; Myalgia	FLU3~PFIZER\WYETH~4020029~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0872M~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193902	11/26/2002	GA	65.0	65		F	10/30/2002	Fever 101; instructed to take Tylenol per instructions on bottle. Soreness and swelling right arm, deltoid area, instructed to apply cold compresses. Oct 30, 2002, 14:45 temp 100, swelling decreasing. Oct 31, 2002 resolved per TC.									Y	10/29/2002	10/29/2002	0	NONE	PUB	PUB	leubid 375mg BID, Lotenson 20mg qd, HRT patch, Destradem	NONE	HTN, Reflux		GA02123	1						1	Myalgia; Oedema; Pyrexia	FLU3~SANOFI PASTEUR~U0921FA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0172M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193903	11/26/2002	GA	65.0	65		F	10/29/2002	Received pneumonia vaccine LD, flu vaccine rd around 9:30 on 10-28-02. Around 17:00 noted LD was reddened, sore and warm to touch, shoulder very sore. 10-29-02, returned to health dept erythema, edeam, induration 4in by 3in noted, skin very warmt to touch. Phoned her Dr.; was seein in his office about 10:30, was given Keflex 500mg Tid, Benadryl 25mg every 3-4 hours, cortison cream Tid. Phoned patient around 16:45 she states she feels a little better, will report further problems. Was better by 16:45 10-29-02.				Y					Y	10/28/2002	10/28/2002	0		PUB	PVT	Keflex 500mg Tid, Benadryl 25mg Q 3-4hrs, Cortisone Cream to LD PRN, Neurontin 100mg Bid, Calcim 600mg Bid, Lopressor 100mg Bid, Amaryl 2mg Qd, Menest 625mg Qd	NONE	Diabetes, irregular heart rate		GA02121	1						1	Erythema; Injection site induration; Injection site warmth; Myalgia; Oedema; Vasodilation procedure	FLU3~PFIZER\WYETH~4020024~7+~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1160L~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193904	11/26/2002	GA	6.0	66		F	10/07/2002	10-3-02 received flu, pnue and TDA immunization at approximately 4:15pm; state approximately 8pm right arm(pnue given) was warm, red; arm hurting and did not sleep well. RTC 10-4-02 at noon, temp 97.8, complained of chills. Right arm red/warm approximate 6in long and 7in around arm, bruise at injections site. 10-7-02 phoned client, state better (arm red) but over weekend red, high temperature, chills, right arm very sore, was very sick per husband also. 10-7-02 arm red only.									Y	10/03/2002	10/03/2002	0		PUB	PUB	Premarin, Alenol, Prevacid	NONE	NONE		GA02117	1						1	Chills; Contusion; Injection site warmth; Myalgia; Pyrexia; Vasodilation procedure	FLU3~EVANS VACCINES~34682HA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0111M~3~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U0525AA~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0193905	11/26/2002	GA	28.0	28		F	10/18/2002	BP 120/80  9:50am red splotchy area on chest, arms, stomach. Client feels hot. Pulse 68  10:15 vomited x 2. Benadryl Elixer 50mg PO given prior to vomiting. 10:45 red splotchy areas disappeared. client sleepy- co worker drove client home.									Y	10/18/2002	10/18/2002	0		PUB	PUB	NONE	NONE	Deaf		GA02116	1						1	Feeling hot; Rash maculo-papular; Somnolence; Vomiting	FLU3~EVANS VACCINES~E34682HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0193906	11/26/2002	GA	69.0	69		F	10/15/2002	Pt phoned 10/11/2002 at 10:30 am. Pt states on 10/08/2002 around 12:30 - 1:00 pm she received Flu vaccine; on 10/08/2002 around 4-4:30 pm she noticed shortness of breath, throat felt swollen, scratchy, she took Benadryl 25mg PO at 4:30 pm.  with in 20 min. Symptoms decrease, 4 hours later took another Benadryl all symptoms gone. on 10/09/2002 took her allergy injection around 9-9:30 am at MD's office; 1-1:30 had same symptoms as 10/08/2002. Went to ER but had taken Benadryl 25mg at 1:30pm. Was in Er from 4:30-6 observed. Only sent home.				Y					Y	10/08/2002	10/08/2002	0	NONE	PUB	PUB	Zestoratic 10/12.5 1 qd, Meclizine 12.5 prn, Nasalnex  2 sprays prn, Lorazepam 1 prn Qx2; Tylenol: allergy injections 1 a week	NONE	Hypertension, Vertigo since 1992, Allergy, Rhinititis, Anxiety attacks		GA02115	1						1	Dyspnoea; Throat tightness	FLU3~PFIZER\WYETH~4020021~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0193907	11/26/2002	TN	33.0	33		F	11/12/2002	Respiratory distress increasing over next several minutes after vaccines. Per MD orderss - Epinphrine 1mg given SQ and 25mg Benadryl given IM. 911 called and oxygen via mask placed at 6L min. EMS takes over at this point. Patient to ER.				Y					Y	11/07/2002	11/07/2002	0		PUB	OTH	hyroxapam, glucophage, pulmacort, topomax, albuterol, prozac, triliptol, effexer	NONE	Diabetes, Asthma, Depression		TN02049	1						1	Respiratory distress	FLU3~PFIZER\WYETH~4020029~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEPA~MERCK & CO. INC.~0701M~1~IM~LA~HEP A (VAQTA)~1|PPV~MERCK & CO. INC.~0210M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193909	11/26/2002	TX	61.0	61		F	10/14/2002	Pt c/o pain and some swelling and reddness at injection site on Sat 10/12/2002: it continued to get worse with the swelling going from shoulder to elbow, pain got worse- went to ER- Dx with cellulitis and put on Cipro (cellulitis of left arm)				Y					U	10/11/2002	10/12/2002	1		PUB	PUB	Breathing Tx z albuterol	NONE	COPD		TX02127	1						1	Cellulitis; Injection site erythema; Injection site infection; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U0925AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0995L~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193910	11/26/2002	DE	15.0	15		M	11/17/2002	Had a reaction to flu, hep A shot given on 11/16/02. Rash on both arms along with chest.				Y					U	11/16/2002	11/17/2002	1		MIL	MIL		NONE	NONE			1						1	Rash	FLU3~SANOFI PASTEUR~U0880AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1105I~UNK~~~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0193911	11/26/2002	NY	84.0	84		F	11/16/2002	Woke up the next morning feeling, I didn't have 5 mins to live. All my children had gone to school they are teachers. I finally got a hold of my grand daughter who gave me some tea-ice bag.									Y	10/21/2002	10/22/2002	1	I took a CT of head, blood tests-all neg	PVT	OTH		NONE				1						1	Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193912	11/26/2002	WI	47.0	47		F	11/19/2002	10/27/02 sx began with numbness, tingling, pain. Dx-transverse myelitis of spinal cord. Pt under treatment-improving.				Y					U	10/20/2002	10/27/2002	7	Negative head MRI, negative cervical cord/thoracid MRI	PUB	PUB	Estrate	NONE	NKA			1						1	Hypoaesthesia; Myelitis transverse; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U0921CA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193913	11/26/2002	ND	51.0	51		F	11/11/2002	Burned after having the shot-20min. given 11/5/02. Evening-sore arm, weak legs, tired, legs ached. 7th-all day ache, warm area 3 x 15/8-red-raised. Saw MD that afternoon. Stayed home Fri-flu symptoms. Returned to work Mon 11/11/02.									Y	11/05/2002	11/05/2002	0	BP-high 140/90 at clinic/ White count done at clinic-was high	PUB	UNK	Paxil, thyroid, synthroid, Premarin, Busbar	NONE	NONE		ND0220	1						1	Blood pressure increased; Fatigue; Injection site erythema; Injection site pain; Injection site swelling; Muscular weakness; Pain; Skin burning sensation; White blood cell count increased	FLU3~PFIZER\WYETH~4020022~5~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0193915	11/26/2002	LA	63.0	63		F	11/13/2002	Began experiencing spasms in right deltoid muscle am after receiving PPV. Later in the evening she experienced shoulder pain radiating to neck and increase scapular area of back. She describes pain as a burning, searing. Has right arm paresis- unable to lift above waist level. Had cortisone injection into shoulder joint 11/4 and 11/09. Took Medrol dose pack x 7 days. Having pt treatments. 3 x 1 wk (2 x to date)				Y					N	11/01/2002	11/02/2002	1		PUB	PUB	NONE	NONE	NONE		LA021104	1						1	Hypokinesia; Muscle spasms; Pain; Paresis; Shoulder pain	FLU3~SANOFI PASTEUR~U0939AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1051L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193916	11/26/2002	OR	1.0	1	.5	M	11/19/2002	Patient has been fine all evening, then parents observed him to be unresponsive, drooling and grunting; face flushed, rash appearing; duration of approximate three minutes at time of call. Advised to go to ER. Temp 101				Y					U	11/19/2002	11/19/2002	0	Previous EEg Abnormal 6/28/02, Normal 7/23/02, MRI normal 6/29/01	PVT	PVT	NONE	NONE	Previous history abn EEG and SZ - none sine 7/02			1						1	Coma; Drooling; Grunting; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U0833~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~48097~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0193917	11/26/2002	OR	42.0	42		F	11/20/2002	Day after receiving immunizations experienced several bouts of vomiting- no advance nausea, no fever, some sweating. Lasted apprx. 12 hours.									Y	11/12/2002	11/13/2002	1		PVT	PVT		NONE	NONE			1						1	Vomiting	FLU3~SANOFI PASTEUR~U0951AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193919	11/26/2002	MA	56.0	56		U		24 hours after injection of vaccine, client complained of sore arm. Noted to have moderate erythema and warmth of lower par tof upper arm (below injection site0 from subcantaneus swelling palpuble.									Y	11/18/2002	11/19/2002	1		PUB	PUB			clindamycin, penicillin, mycolog cream			1						1	Erythema; Myalgia; Oedema	FLU3~SANOFI PASTEUR~U0969AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193921	11/26/2002	CA	53.0	52		F	11/06/2002	Localized reaction to IM injection of influenza vaccine, reddness, swelling, pain lasted approximately 3-5 days.									Y	10/23/2002	10/25/2002	2		OTH	PVT		NONE	UNK			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~EVANS VACCINES~E34722HA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0193922	11/26/2002	CA	47.0	47		F	11/06/2002	Localized reaction to IM injection of influenza vaccine - redness, swelling, discomfort lasted about 3 days.									Y	10/08/2002	10/08/2002	0		OTH	PVT		NONE	UNK			1						1	Discomfort; Injection site erythema; Injection site oedema	FLU3~EVANS VACCINES~E34722HA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0193923	11/26/2002	GA	40.0	40		M	11/08/2002	Site of injection was tender for first two days then became very sensitive/painful to touch on Wed/Thurs. Site began swelling and skin was blotch redy. Took Advil. Saw primary Dr. on Friday 11/8/02. Dr said probably cellulitis infection. Patient go IM Rocephin Fri/Sat/Sun patient well. Follow up with Dr. Monday 11/11/02.				Y					Y	11/04/2002	11/06/2002	2		OTH	PVT	Effexor	NONE	sulfa allergy			1						1	Erythema; Injection site hypersensitivity; Injection site oedema; Rash macular	FLU3~SANOFI PASTEUR~U0875AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0111M~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193924	11/26/2002	MD	33.0	33		F	11/06/2002	Patient developed a red/itchy rash within 24 hours that progresed the next day. Patient treated with atanoy and prednisone									Y	11/04/2002	11/05/2002	1		PUB	PUB						1						1	Erythema; Pruritus; Rash	FLU3~PFIZER\WYETH~4020028~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0193925	11/26/2002	IL	41.0	41		M		Right leg warm to touch, red and swollen.									Y	11/13/2002	11/15/2002	2		PUB	OTH		NONE	NONE			1						1	Erythema; Oedema peripheral	DTAP~SANOFI PASTEUR~U0584AA~UNK~IM~~DTAP (TRIPEDIA)~1|FLU3~PFIZER\WYETH~4020007~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0193927	11/26/2002	GA	43.0	43		F	11/22/2002	Pt developed pain left forearm and left calf day after influenza vacc. Also had swollen left calf. We believe that vaccination cause exacerbation of membrane corrective tissue disorder.									Y	11/13/2002	11/14/2002	1	Doppler U/S left calf	PUB	PUB	Prilasec and Papaya enzymes	GERD	CREST syndrome			1						1	Injection site pain; Oedema	FLU3~SANOFI PASTEUR~U0934AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193928	11/26/2002	NV	77.0	76		M	11/25/2002	Barely able to walk at time. Chills, muscle aches, cough and sore throat occasionally. Headaches									N	11/11/2002	11/12/2002	1		UNK	UNK						1						1	Abasia; Chills; Cough; Headache; Myalgia; Pharyngolaryngeal pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193929	11/26/2002	IL	71.0	71		F	11/25/2002	Swelling. Lot of pain. very red. some limited use of the arm where the pneumonia shot was given.									U	11/21/2002	11/21/2002	0		UNK	UNK						1						1	Hypokinesia; Injection site erythema; Injection site oedema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0193930	11/26/2002	MO	38.0	37		F		The day following the vaccines, the left upper arm was red and hot to touch. The day after that, the redness was gone but there was petechiae an inner aspect of L forearm. Remained 24 hrs.									Y	11/06/2002	11/07/2002	1	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Injection site erythema; Injection site warmth; Petechiae	FLU3~SANOFI PASTEUR~~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193932	11/26/2002	OH	26.0	26		U		Rash on face only. Some remains body no Rx no evaluation.									U	11/18/2002	11/20/2002	2		UNK	UNK						1						1	Rash	FLU3~SANOFI PASTEUR~U0905FA~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193933	11/26/2002	MI	83.0	83		F	11/19/2002	Presented in ER with numbness in feet with difficulty walking-admitted to ICU. Became totally paralized. Dx GBS- per EMG, MRI, increase CSF Protein. No seroxy or motor functions from head to feet, intubated, Rx plasma phoresis. Now some movement in upper arm. The 60 day follow up received on 8/9/03 states she required intermittent ventilatorassistance as of Feb. 2003. Feb. 2003, family had the pt transferred.  Annual follow up on 12/12/03: Vaccine recipient is unknown to recovery status.				Y	Y				N	10/31/2002	11/07/2002	7		PVT	PVT	Prinvil, Lanoxin, Lasix, Kloreon, Paxil, Zocor, Fosamax		HTN, CHF, CAD, hyperlipidemia, osteoarthritis, allergic to pcn and sulfa			1						1	CSF protein increased; Electromyogram abnormal; Endotracheal intubation; Gait disturbance; Guillain-Barre syndrome; Mechanical ventilation; Paralysis; Plasmapheresis; Sensorimotor disorder; Unevaluable event	FLU3~SANOFI PASTEUR~U0945AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0193934	11/26/2002	MA	79.0	68		M	11/18/2002	Diffuse erythema, swelling, warmth on R arm extending from shoulder (deltoid) area to forearm below elbow on both flexor at extensor surfaces-to axilla on flex or aspect forearm. No palpable adenopathy; sweats/chills, resolving.				Y					Y	11/15/2002	11/16/2002	1		PUB	PUB	Norvasc, Synthroid	NONE	NKA			1						1	Chills; Hyperhidrosis; Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U0969AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0923L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193935	11/26/2002	SC	38.0	38		F	11/15/2002	Rec'd flu vaccine 11/6. Notes swelling, pain, redness at site. Exam shows 2cm area of erythema at site and 8x8 area erythema anterior and medial to injection site. Some warmth and purplish area. No nodes.				Y					U	11/06/2002	11/08/2002	2	NONE	PVT	PVT	Xanax, Prevacid, Dalmane, Celexa, Premarin, Bellergal, Cephadryne	NONE	NONE			1						1	Contusion; Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLU3~EVANS VACCINES~E33352GA~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0193936	11/26/2002	IL	76.0	76		F	11/19/2002	Redness, warmth and tingling at site and right upper arm. No systemic symptoms.				Y					Y	11/15/2002	11/15/2002	0	NONE	PVT	PVT	Detrol XL, ASA, Micardis,Citracal D	NONE	NKA			1						1	Injection site erythema; Injection site warmth; Paraesthesia	FLU3~PFIZER\WYETH~4020017~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1160L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193937	11/26/2002	UT	66.0	66		F	11/15/2002	Pt came to clinic on 11/15/02 at 4:25pm reporting that she received a pneumonia and flu shot on 11/11/02 at this clinic: pt c/o of redness, swelling in left tricep following these shots.									U	11/11/2002	11/12/2002	1		PUB	UNK	Lavaste, protonics, La Voxel, Furosmide, Fentermine, Celebrix, Celexcia, Diazapam, Oxyodone, Loritabs, Tums	NONE	Opthalmic ointments ending in cin, hypertensive, thyroid			1						1	Injection site erythema; Injection site oedema	FLU3~PFIZER\WYETH~1139~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1039~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193938	11/26/2002	OH	44.0	44		F	11/19/2002	One day post immunization: localized pain at injection site, no tx. One week post immunization: decreased ROM in L arm due to increased pain, no redness or swelling, tx with ibuprofen; continued for 5 wks and evaluated 11/19/02. Symptoms and treatment ongoing as of this date.									U	10/15/2002	10/16/2002	1		PVT	PVT	Synthroid, Paxil	NONE	Asthma, seborrhed/eczema			1						1	Hypokinesia; Injection site pain; Pain	FLU3~EVANS VACCINES~E34102HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0193940	11/26/2002	IL	21.0	21		F	11/15/2002	Itchy rash on neck the next am. Lasted for 12 days- no Tx to it. Now resolved. no temperature									Y	10/30/2002	10/31/2002	1	NONE	OTH	PVT	Detrol 2mg, Topomax 300mg, Keppra 2000mg, Allegra 180mg	NONE	Seasonal Allergies, seizure disorder			1						1	Rash pruritic	FLU3~SANOFI PASTEUR~U0886AA  exp 06~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193942	11/26/2002	MI	41.0	41		M	11/07/2002	Nausea, cramps, diarrhea, aching, dizziness, headache									Y	11/03/2002	11/03/2002	0	NONE	MIL	MIL	Nexium, Prinivil	NONE	High Blood Pressure			1						1	Diarrhoea; Dizziness; Headache; Muscle spasms; Nausea; Pain	FLU3~SANOFI PASTEUR~U0983AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193943	11/26/2002	NE	86.0	86		F	11/18/2002	Received phone call from RN who works with patient in cardiac rehab at hospital. RN reported patient had redness from left chest wall down left arm to left wrist with some ecchymossi. RN also noted some wheezing.									U	11/16/2002	11/16/2002	0	Contacted Health Care Provider	PUB	PVT	UNK	NONE	NONE			1						1	Ecchymosis; Erythema; Wheezing	FLU3~SANOFI PASTEUR~U0946AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0541~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193944	11/26/2002	FL	50.0	50		F	11/14/2002	Within 2 hours of injection, soreness right upper arm, then began to feel weak and fever 100-101. Next day palpitation and chest pain worsened by pressure/palpation. Review of systems shows erythema around site and edema to end of mid humerus. Treament H2 blocker. Better by 11/11/02.									Y	10/29/2002	10/29/2002	0		PVT	PVT	Claritin, Monocril, HCTZ, Atenolol		Allergic to Penicillin; Hypertension, renal insufficiency, anemia			1						1	Asthenia; Chest pain; Erythema; Myalgia; Oedema; Palpitations; Pyrexia	FLUX~UNKNOWN MANUFACTURER~4020011~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0210M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0193945	11/26/2002	MI	43.0	43		U		Pt received pneumonia vaccine and 2 hours after receiving the injection he started experiencing stiffness in the arm. At 3:00am on 11/05/2002 he was experiencing excruciating pain. Unable to lift his right arm and went to the ER. He was given an Rx for Lorcet.				Y					Y	11/04/2002	11/04/2002	0	NONE	PUB	PVT	Nasprasyn insulin, Antihypertensives		Rheumatoid Arthritis, Hypertension, Diabetes			1						1	Hypokinesia; Musculoskeletal stiffness; Pain	FLU3~PFIZER\WYETH~4020028~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~011M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193946	11/26/2002	CA	58.0	58		F	11/19/2002	Paleness, weakness, fast heartbeat, Dizziness									U	11/19/2002	11/19/2002	0		OTH	UNK	Extra Strength Tylenol, Buspar (mg)	Headache	Asthma, Migraines			1						1	Asthenia; Dizziness; Heart rate increased; Pallor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193947	11/26/2002	CA	50.0	49		F	11/14/2002	Red blotchy skin around chest/neck area. Difficulty breathing immediately after PPV injection. Flu injection administered at around 8am. Returned same day after 10:30 for pneumonia vaccine									Y	11/05/2002	11/05/2002	0		UNK	UNK	Wellbutrin SR 75mg	NONE	NONE			1						1	Dyspnoea; Erythema; Rash macular	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0193948	11/26/2002	TX	63.0	63		F		With in 24 hours. Experienced flu like symptoms, including pain behind the right ear. Muscle pain increased to the point pt believed she had a stroke. Dx by MD was Bell's Palsy. Tx began 48 hours after shot.				Y					N	10/29/2002	10/31/2002	2	NONE	PVT	PVT		Type 2 Diabetic	Type 2 Diabetic			1						1	Ear pain; Facial palsy; Influenza like illness; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0193949	11/26/2002	MS	2.0	2	.5	M	11/13/2002	Rash on face only									Y	11/08/2002	11/08/2002	0		PVT	OTH			NONE			1						1	Rash	FLU3~SANOFI PASTEUR~U0882AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193950	11/26/2002	CA	70.0	70		F	11/15/2002	Dizziness, muscle ache and fatigue. Fever and chills. Condition lasted through 11/09/2002									Y	11/05/2002	11/05/2002	0		PVT	UNK	Advair, Tylenol		Asthma			1						1	Chills; Dizziness; Fatigue; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193951	11/26/2002	IA	69.0	69		M	11/18/2002	Client reports fever 101 degrees (oral) on evening of 10/15/02. Redness and swelling at injection site (pneumococcal) upper right arm and extending into right forearm. He called the physician-inst to take Benadryl 25mg q 4 hrs, apply ice. To MD 10/17-continue ssame treatment.				Y					Y	10/15/2002	10/15/2002	0		PUB	PUB		NONE	NONE			1						1	Injection site erythema; Injection site oedema; Pyrexia	FLU3~SANOFI PASTEUR~U0882AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1161L~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0193952	11/26/2002	WA	30.0	30		M	11/17/2002	Fever- in 24 hrs, b/w 99.9 and 102.5. CHills, nausea/1 vomit spell, brief. Cough-productive, aches, fatigue. Most severe symp gone in 36 hrs; approx 24 hrs more to totally done.									Y	11/12/2002	11/12/2002	0	NONE	PVT	PVT	NONE	NONE	Penicillin; slight to peanuts			1						1	Cough; Fatigue; Nausea; Pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U0952AA~4~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0193953	11/26/2002	MO	71.0	71		M	11/19/2002	High fever 102 degrees, chills, coughing. Referred to PMD.  Per acknowledgement letter, box 8 should be marked none of the above.									U	11/07/2002	11/17/2002	10	NONE	PUB	UNK		NONE	NKA			1						1	Chills; Cough; Pyrexia	FLU3~PFIZER\WYETH~4020027~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0193954	11/26/2002	TX	30.0	40		F	11/12/2002	Emp rec'd vaccine to L arm, 45 mins later return to nurse c/o rash to R arm, blotching red skin to face, rapid pulse, swelling of face. Given .2 Epi. Then to put MD office.				Y					Y	11/12/2002	11/12/2002	0	UNK	OTH	OTH	NONE		NONE			1						1	Erythema; Face oedema; Heart rate increased; Rash; Rash macular	FLU3~SANOFI PASTEUR~U0933AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193955	11/26/2002	RI	69.0	69		M	11/19/2002	Pt reported that about 1 month ago 10/10/02 he had a flu shot which he believes resulted in stiffness which began 2-3 days following. Affects his right arm, shoulder and hand. Also his hand is nunbness. Denies pain except for soreness 1-2 days following injection.				Y					U	10/10/2002	10/12/2002	2		PUB	PVT	UNK	NONE	UNK			1						1	Hypoaesthesia; Injection site pain; Joint stiffness	FLU3~SANOFI PASTEUR~U0929AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193956	11/26/2002	MA	68.0	68		F	11/05/2002	10/30/02 SOB, headache, dizzy-felt sick.									Y	10/29/2002	11/02/2002	4		PUB	PVT	Medicine for thyroid, arthritis, not sure	NONE	Hyperthyroid, hypoglycemia, arthritis			1						1	Dizziness; Dyspnoea; Headache; Malaise	FLU3~SANOFI PASTEUR~U0969AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194012	11/26/2002	MA	56.0	56		F	11/25/2002	Numbness in left arm extending to thumb, index and middle finger at night especially. Very, very severe rash all over body; feel as if skin is on fire. Have not been able to sleep.									N	11/09/2002	11/09/2002	0		UNK	UNK						1						1	Hypoaesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0194017	11/26/2002	NY	4.0	4		M	11/18/2002	Approximately 5 minutes after vaccinations, patient began coughing and gagging and complaints of pain in feet. Looked pale. 5 minutes later, developed erythroderma and was scratching his ears and crying. Given Benadryl 25mg. Observed for 40 minutes. Pruritus and paleness resolved.									Y	11/15/2002	11/15/2002	0	None	PUB	PUB		None	None			1						1	Cough; Crying; Dermatitis exfoliative; Pain in extremity; Pallor; Pruritus; Retching	DTAP~SMITHKLINE BEECHAM~548A2~5~~LA~DTAP (INFANRIX)~1|FLU3~PFIZER\WYETH~4020026~1~~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|IPV~SANOFI PASTEUR~U0823~4~~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~O0141~2~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0194055	11/26/2002	FL	1.4	1	.5	M	11/08/2002	R leg with swelling, erythemaous, and warm to touch. 2 days ago shots were given.				Y					U	11/06/2002	11/06/2002	0	NONE	PVT	PUB	Augmentin 2W 15ml, Poly-Vi, Tussi-12DS, Floxin, elidel CR		OM, OE chronic			1						1	Injection site erythema; Injection site oedema; Injection site warmth	DTAP~SMITHKLINE BEECHAM~572A2~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U0936FA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~U1275~3~SC~LL~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0194074	11/26/2002	NM	25.0	25		F	11/26/2002	Morning after receiving immunization member's mother called.  Member started having stomach pains, headache, felt like chest was being compressed.  Member escorted to ER at Loveless. Given Tylenol & Tylenol#3.  Advised to not get flu vaccine again.  This was member's first flu shot.				Y					Y	11/23/2002	11/23/2002	0	N/A	MIL	MIL						1						1	Abdominal pain upper; Headache	FLUX~UNKNOWN MANUFACTURER~U0987~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0194077	11/26/2002	MA	5.0	5		M	11/26/2002	red pinpoint papules in plaques primarily over left back from hips to neck, sparse on right side of back, sparse on axillary line left upper arm, barely crosses midline of chest, goes just over mandible of cheek.  rash started on day after admin of vaccines									Y	11/19/2002	11/20/2002	1		PVT	UNK	albuterol inhaler	none - here for well child visit	mild intermittant asthma			1						1	Rash papular	DTAP~UNKNOWN MANUFACTURER~U0548db~5~IM~LA~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~U953AA~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~SANOFI PASTEUR~U0903~4~IM~LA~POLIO VIRUS, INACT. (POLIOVAX)~1|MM~MERCK & CO. INC.~0545M~2~IM~RA~MEASLES + MUMPS (MM-VAX)~1	USA		Influenza
0194177	11/26/2002	WI	47.0	47		F	11/26/2002	Administration site reaction-Red and warm 3 diameter with hard lump in middle about 1 in diameter. L Deltoid region.									Y	11/04/2002	11/04/2002	0		UNK	PVT	Synthroid 220 mg QD Acifex 20 mg QD Multivit 1 tab QD Vit E 400 IU QD Vit C 500 MG QD Calcium 500 with Vit D 200 QD Actifed 1 tab QD	None	Thyroid Cancer -Surgically treated and cured. Seasonal allergies			1						1	Injection site erythema; Injection site mass; Injection site warmth	FLU3~SANOFI PASTEUR~U088AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194096	11/27/2002	NH	103.0			F	11/11/2002	10/7/02 received flu vaccine. 10/14/02 reported visual problems. 10/22/02 cranial neuropathies believed to be flu vaccine demyelinating polyneuropathy or G.B.S. Follow-up received on 02/12/03: received vaccine at work - mft and lot # unavailable. there. Medical records state nystagmus. msv					Y				Y	10/07/2002	10/22/2002	15	10/22/02 normal MRI	UNK	UNK			Allergies codeine, hypertension, Raynaud's syndrome, saccoid in remission.			1						1	Demyelination; Guillain-Barre syndrome; Neuropathy; Nystagmus; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0194101	11/27/2002	CT	20.0	20		F	11/20/2002	Numbness bilat hands, loss of grip strength, left arm cramps and stiffness. General malaise, nausea, headache 1-10(4) loss of appetite, sluggish, fatigue.									U	11/16/2002	11/17/2002	1	NONE	MIL	MIL	NONE	Congestion	NONE			1						1	Anorexia; Asthenia; Fatigue; Hypoaesthesia; Malaise; Musculoskeletal stiffness; Nausea; Somnolence	ANTH~EMERGENT BIOSOLUTIONS~066~1~SC~~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~4020032~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194104	11/27/2002	IL	55.0	55		M	12/19/2002	Client has reddened area at injection site approximately 3/4 in diameter. From this area radiating around back of arm is a reddened streak approximately .5 wide and 6 long. Injection site is site of pneumonia vaccine.									Y	11/19/2002	11/20/2002	1		PUB	PUB		None	None			1						1	Cellulitis; Injection site erythema	FLU3~SANOFI PASTEUR~U0946AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1353L~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194105	11/27/2002	NY	36.0	35		F	11/21/2002	11-12-02 to MD for sinus infection. Rx for Avelex. Given Flu shot. 11-13-02 felt general aches. 11-14 Increased soreness, difficulty moving. Pain especially in neck, back. 11-15 increased pain, mobility. Avelex D/C. 11-16 sever pain continued. 11-20 unable to work. 11-21-02 patient returnd to work. Taking muscle relaxant and Aleve for pain. Feels better but not completely recovered.									U	11/12/2002	11/13/2002	1		PVT	PVT	Avelex, Birth Control Pills	Sinus Infection	NONE			1						1	Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0194106	11/27/2002	OH	54.0	54		F	11/08/2002	Got flu vac Tues morn, 11/05/02, By eve 11/05/02 lt upper arm swollen & inj site red, warm + tender 5 cm diameter, Some itching around area. Used ice and Benadryl. Has imporoved but I was encouraged to report event. 2) Past-erythema S/p PPD had 2nd step which was neg, / Thimerosal H/D rash to merthiolate. DX : Hematoma, focal cellulitis										11/05/2002	11/05/2002	0		UNK	UNK			allergy- Mold, Gentamycin + bad reaction to netro/vascular headache.			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~UO877AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194107	11/27/2002	NY	62.0	61		F	11/20/2002	Adverse reaction to influenza vaccine. Induration of injection site 4cm diameter. Redness, induration of 2.5cm; tender to palpitation. Fever, chills.										11/13/2002	11/14/2002	1	None	UNK	UNK			Allergic to penicillin and sulfa. Gout, Nephrolithiosis			1						1	Chills; Erythema; Injection site induration; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~U0910AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194108	11/27/2002		28.0	28		F	11/05/2002	High blood pressure, heart palpitations, light headed, numbness and tingling in arms, cotton-mouth, feverish very hot, shakey										11/01/2002	11/01/2002	0	EKG- Normal	UNK	UNK						1						1	Dizziness; Dry mouth; Hypertension; Palpitations; Paraesthesia; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U0882AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194109	11/27/2002	AK	39.0	39		M	10/17/2002	Erythema & swelling approx 2' inferior to chromium process extending to just superior of antecubital space. Tenderness to touch, Left upper arm.									U	10/15/2002	10/16/2002	1		OTH	OTH			NKA		AK200246	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~UO885A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1161L~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194110	11/27/2002	AK	36.0	36		F	10/17/2002	Tenderness, redness right upper arm developed about 18 hours after injection. Area does not appear swollen. Patchy pink areas noted above injection site but seem superficial and not uniform in size or shape.									Y	10/05/2002	10/16/2002	11	NONE	PUB	UNK			NONE		AK200247	1						1	Erythema; Myalgia	FLU3~SANOFI PASTEUR~U0885AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1161L~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194111	11/27/2002	AK	57.0	57		F	10/21/2002	Vaccine given in left deltoid. Two hours after immunization, extreme soreness, redness, and hot to touch. Redness 3 to 4 inches below injection site continues.									Y	10/18/2002	10/18/2002	0	NONE	PUB	PUB	HTN Meds, Verapamil, Atenolol	Sinus	High blood pressure, allergy; sulfa, horses	Hives~Td Adsorbed (no brand name)~~16.00~In Patient	AK200248	1						1	Injection site hypersensitivity	FLU3~SANOFI PASTEUR~U0885AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1351L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194112	11/27/2002	AK	58.0	58		F	10/24/2002	Rec'd Pneumovac RD on 10/22/02, Return to clinic today 10/24/02 presenting with warm, pink, painful area measuring 12.0 cm X 4.0 cm + is 4.0 cm below injection site. Also has right middle finger with infection (no streak)									U	10/22/2002	10/23/2002	1	Picture taken and sent via Tele Med to MD in Bethel	PUB	PUB		Cut finger, right hand, middle finger	NKA, Hard of hearing		AK200249	1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~UO885AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1161L~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194113	11/27/2002	AK	41.0	41		F	10/14/2002	Hard, red swollen in deltoid area and 5 inches wide band. Spoke with another that afternoon same day of flue shot. Used Benadryl PO and ice. Was clearly looking better by bedtime and gone next morning.									Y	10/09/2002	10/09/2002	0		PUB	PUB	NONE	NONE	NONE		AK200244	1						1	Injection site oedema	FLU3~SANOFI PASTEUR~U0885AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0735M~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194114	11/27/2002	AK	61.0	61		F	10/02/2002	Redness and swelling of upper arm, pain at injection site. Redness continues up over shoulder ending before scapula. Low temperature reported.									Y	09/30/2002	09/30/2002	0		PUB	PUB		NONE	NONE		AK-2002-41	1						1	Body temperature decreased; Erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U0885AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1160L~3~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194115	11/27/2002	AK	59.0	59		F	10/08/2002	Swollen,red area, size of grapefruit on left arm,  fever, area was tight and red, saw FNP, dx sterile cellulitis, abx rxd, r/t fever, 5/8' needle used for IM injections. I was notified by the pt about the Dr visit and the FNP has called				Y					Y	10/03/2002	10/04/2002	1		PUB	PUB		NONE	NKA		AK200242	1						1	Cellulitis; Injection site erythema; Injection site induration; Injection site swelling; Pyrexia	FLU3~SANOFI PASTEUR~UO885AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1161L~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0194116	11/27/2002	SC	27.0	27		F	11/18/2002	Employee state that event of receiving Flu vaccine, broke out in rash around injection site of right side of body. States she took Benadryl. No respiratory problems per employee.									Y	11/12/2002	11/12/2002	0		OTH	PUB		NONE	NONE		SC0253	1						1	Injection site hypersensitivity	FLU3~SANOFI PASTEUR~U0935BA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194117	11/27/2002	CA	60.0	60		M	11/19/2002	I received an Influenza Vaccination at approximately 10:00am on Tuesday, 12 Nov 02. I noticed immediatley after the shot, that this was more painful than the ones in the past. At around 1:00pm that afternoon, I started feeling lightheaded and faint. I was still feeling lightheaded when I left work that afternoon. I thought maybe I was coming down with the Flu. When I arrived home, I noticed my arm was extremely swollen and ver sore. After dinner, around 6:00pm, I sat down to read and watch TV. All of a sudden, everything in the room started spinning. I would move my eyes from the paper I was reading to the TV and back, and it would make it worse. I started getting nauseated. This spell lasted approximately 2-3 minutes. The spinning episodes occurred again 3 or 4 more times before I decided to go to bed. This was approximately 9:00pm. When I laid down in bed, this is when it (spinning) hit me the hardest along with getting nauseated again. Nothing I did could make it go away. It never dawned on me to call my doctor, since I was not aware of any adverse effects from a flu shot and I had not had any effects in the past. This last spinning/nauseated episode lasted approximately 5 minutes, then I dozed off to sleep. In the morning, I awoke with a tremendous headache. By Friday, November 15, the swelling and soreness were gone. The headache would come and go fro the next few days. Saturday, November 16, 2002, the headache turned into a migraine. As of today, Monday, November 18, 2002, my head is still a little sore from all those headaches. i feel a little weak and as though I am getting sick (the Flu?)									U	11/12/2002	11/12/2002	0		OTH	PVT		NONE	Type II Diabetes			1						1	Dizziness; Headache; Nausea; Oedema; Pain; Vertigo	FLU3~SANOFI PASTEUR~U0940AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194118	11/27/2002	MD	37.0	37		F		Severe pain at shoulder when vaccine was injected. Tingling in arm. Some of pain went away but still soreness of arm. Mother suffered the same reaction. Took mother 3 days for her arm to recover. Most painful inoculation patient got.									N	11/26/2002	11/26/2002	0		UNK	UNK						1						1	Injection site pain; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0194119	11/27/2002	UT	66.0	66		F	10/28/2002	AM of 1/12 noticed hives like rash on right arm at site of injection. Rash spread to trunk, back, shoulders, then face. Stated it took 6 days to resolve. Experienced no difficulty breathing. No fever, No medications taken for relief of rash. Did not consult a physician. Called & requested a VAERS report submitted.									Y	10/11/2002	10/12/2002	1	NONE	PUB	PUB	Baclofen	NONE	allergy to sulfa, HX of hives-cause unknown		UT022520	1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~UO883AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~)11M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194120	11/27/2002	ND	44.0	44		F	11/20/2002	2 hours after vaccine, temp 102 for 4 hours. 24 hours after vaccine hives for 12 hours. Treatment Tylenol and Benadryl.									Y	11/15/2002	11/15/2002	0		PUB	UNK		NONE	Penicillin, Codiene, Chronic sinus			1						1	Pyrexia; Urticaria	FLU3~PFIZER\WYETH~4020034~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0735M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194121	11/27/2002	OH	26.0	26		F	11/20/2002	Painful, swollen(right deltoid area) site noted next AM. Temp as high as 102 degrees F on the 18th + 100 to 100.8 19th. The 20th (3rd day post injection) temp still about 99-100, Right arm very painful as well as site swollen, red and painful to touch. Dr was notified.									Y	11/17/2002	11/18/2002	1		PUB	PVT		NONE	HX of splenectomy several years ago			1						1	Injection site erythema; Injection site pain; Injection site swelling; Pyrexia	FLU3~PFIZER\WYETH~4020016~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1351L~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194122	11/27/2002	GA	50.0	50		M	10/30/2002	Immediate local reaction, quarter size red swollen area around injection site, heat around read area, patient denies symptoms of systemic reaction, monitored patient in HO for 30 minutes after injection.									Y	10/16/2002	11/16/2002	31		PUB	UNK		NONE	NONE			1						1	Injection site oedema	FLU3~EVANS VACCINES~E34682HA~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0194123	11/27/2002	GA	5.0	5		F	11/21/2002	Pt rec'd Fluzone vaccine in same arm as IPV on 11/10/02. that night, side red + swollen. Today, entire upper arm swollen, hot + red localized reaction w/ second degree cellulitis									Y	11/19/2002	11/19/2002	0	NONE	PVT	PVT	NONE	BOM	NKA			1						1	Cellulitis; Injection site erythema; Injection site swelling; Injection site warmth	DTAP~SMITHKLINE BEECHAM~576A2~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UO925AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~U1234~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0194124	11/27/2002	GA	68.0	68		F	10/16/2002	10/10/02 pt at health dept with c/o redness and inflammation in L arm below flu shot area with itching. No other complaints. Area appeared red and inflamed approx 1 inch below from shot area. Referred to PMD for evaluation and recommendation for future flu shots. 10/11/02 call from pt went to ER and received antibiotics and med for itching. Was told unsure of cause of inflammation and swelling but could continue flu shots in future.				Y					Y	10/08/2002	10/08/2002	0		PUB	PUB		NONE				1						1	Injection site erythema; Injection site hypersensitivity; Injection site inflammation; Pruritus	FLU3~EVANS VACCINES~34682HA~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0194125	11/27/2002	TN	74.0	74		F		Rash on body, Ears, turned red and burned, Face felt flushed, Dr prescribed Prednisone, Rash left in about 5 days, No ill effects afterwards, Have no previuous reactions to influenza vaccine prior to this.				Y					Y	11/05/2002	11/07/2002	2		PUB	OTH		NONE	Acid Reflux			1						1	Erythema; Flushing; Rash; Skin burning sensation	FLU3~PFIZER\WYETH~4020023~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0194126	11/27/2002	WV	49.0	49		M	11/22/2002	Pt with chronically elevated CK levels before vaccine S/P GSW RUE 4/87 noted increase myalgias at site of injection acorss both shoulders. Pt rec'd Lyme vac 5/99-7/00.				Y					N	10/08/2002	10/08/2002	0	Elevated CK level	PVT	PVT	Tricor, Tydrocyzine, Prilosec, Vioxx, Effexal, Niacur, ASA, Toprol, Diovan	NONE				1						1	Blood creatine phosphokinase increased; Myalgia	FLU3~SANOFI PASTEUR~U0872AB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0194127	11/27/2002	WI				M	11/20/2002	C/O chills for past week, shaky and feverish not feel well since got the shot. Did not see MD. No other vaccines taken.									Y				NONE	PUB	UNK						1						1	Body temperature increased; Chills; Malaise	FLU3~PFIZER\WYETH~4020022~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0194128	11/27/2002	NY	61.0			F	11/21/2002	Received flu shot at 10:35 11/21/02. Returned at 10:45-lightheaded, nausea P64 10:50 drinking water 130/100 P68, 11:00 eating small danish. No trouble swallowing. 11:10 120/80, 56, chatty. 11:20 ambulated to front upstair area in building. 11:25 diaphoretic, pale, lightheaded 130/82 52 0.5cc Epi SQ. 11:35 EMT's arrive report given and received transported to ER.				Y					U	11/21/2002	11/21/2002	0		OTH	PVT	NONE	NONE	Sinus allergies, osteo			1						1	Blood pressure increased; Dizziness; Hyperhidrosis; Nausea; Pallor	FLU3~PFIZER\WYETH~4020011~2~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0194129	11/27/2002	MO	1.0			M	11/20/2002	MMR 11/14/01. On 11/25/01 seen in ER for increase diarrhea temp 11/21/01-11/23/01 to 102.5 (max) and viral exanthem noted in ER. Seen in office 11/26/02. Pt had history of chronic diarrhea x mos and had been previously seen by ped GI specialist-worse after vaccine initially parents feel he has been pickier eater/less wiling to eat textures since. Is diagnosed with sensory integration. No at this time.				Y					U	11/14/2001	11/21/2002	372	NONE	PVT	PVT			Chronic diarrhea x mos; initial food alleriges-further testing revealed none			1						1	Condition aggravated; Decreased appetite; Pyrexia; Rash	FLU3~SANOFI PASTEUR~40597AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1092L~1~IM~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0194130	11/27/2002	MD	16.0	16		F	11/15/2002	Received flu vaccine on 11/4/02-3 days later pt felt tingling in hand, pain radiated down arm to fingers, dropping pen, limited range of motion. Referred to neurologist for nerve conduction studies.									N	11/04/2002	11/08/2002	4	Referred to neurologist for nerve conduction studies.	PVT	PVT	Advair inhaler	NONE	Asthma			1						1	Joint range of motion decreased; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U0930FA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194131	11/27/2002	GA	49.0	49		M	11/19/2002	Rash, welts, itching noted 11/14/02 4pm. Went to physician 11/15/02-symptoms got worse after Decdron-relief with Benadryl. Went to ER 1pm 11/16/02. On Medrol dose pack.				Y					Y	11/13/2002	11/14/2002	1		PUB	PUB	Multivitamin		NKA			1						1	Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U0925AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0194132	11/27/2002	LA	46.0	46		F	11/19/2002	Fever, chills for approx. 3 days. Rapid pulse (110), rapid breathing and wheezing. I got hoarse. I considered going to hospital, but felt there was nothing they could do. Your website does not indicate if there was any remedy.									Y	11/01/2002	11/01/2002	0		OTH	OTH		NONE	NONE			1						1	Chills; Dysphonia; Heart rate increased; Pyrexia; Respiratory rate increased; Wheezing	FLUX~UNKNOWN MANUFACTURER~~4~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0194133	11/27/2002	OH	57.0	57		F	11/16/2002	C/O Lt arm very sore-Lg red area (6 diameter). Both legs and arms hurt, achy, 24 hrs later sx's worsened-felt very weak. Ended up (post being seen in our office 11/6 and 11/7) in ER 11/7/02 evening.				Y					Y	11/05/2002	11/06/2002	1		PVT	PVT	Vioxx, ASA, Premarin, folic acid, methotrexate	NONE	Sulfa allergy; R.A.; GERD			1						1	Asthenia; Injection site erythema; Injection site pain; Pain	FLU3~EVANS VACCINES~E35812KA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0445N~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0194134	11/27/2002	MI	71.0	72		M	11/20/2002	Severe pain to entire L arm; no local reaction, a single dot where needle entered; spasms to entire shoulder 7 hrs after injection given.				Y					U	10/11/2002	10/11/2002	0	NONE	PVT	OTH	Allopurwol, protonix, Zovirax	NONE	NONE			1						1	Muscle spasms; Pain	FLU3~SANOFI PASTEUR~U0928AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1050L~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0194135	11/27/2002	MI	57.0	58		F	11/20/2002	Arm sore and swollen after shot for two days locally, then progressed to sore entire arm, neck and past shoulder/back area. Still bruised 6 days later when in office 11/12/02.				Y					U	11/06/2002	11/06/2002	0	NONE	PVT	UNK	Lipitor, Zostell, Premarin, Rotlat	NONE				1						1	Contusion; Injection site oedema; Injection site pain; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0194136	11/27/2002	MI	68.0	68		F	12/27/2002	Pain and stinging at inj. site-later radiating pain into back and shoulder, mild spasms. Tx Clebrex 200 #30 tqd seen 11/12/02.									N	10/30/2002	10/30/2002	0	NONE	PVT	OTH	Zantac, Synthroid, Toprol, K-our, Prinizide		Zestril			1						1	Back pain; Injection site pain; Muscle spasms; Pain	FLU3~SANOFI PASTEUR~U0928AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194137	11/27/2002	CA	65.0	65		F	11/14/2002	Pneumovax L deltoid 11/5/02. 11/6/02 afternoon injection site hot, swollen-myalgia, cold, headache-continued spread redness swelling warmth L upper arm. Exam 11/8/02 6 area L upper arm.									Y	11/05/2002	11/06/2002	1	NONE	PVT	OTH	Zocor, Premarin, Naponcen, hydrochlorotheozide, Lasinoprol	NONE	Penicillin allergy, hypertension, hyperlipidemia, obesity			1						1	Feeling cold; Headache; Injection site erythema; Injection site oedema; Injection site warmth; Myalgia	FLU3~EVANS VACCINES~E34702HA~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0709M~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194138	11/27/2002	TN	10.0	10		M	11/20/2002	Pt seen 24 hrs later with c/o itching pain and erythema at site. On PE had 4x5cm area of erythema, tenderness, pruritus, no wheezing.									N	11/19/2002	11/19/2002	0	NONE	PVT	UNK			Asthma, allergic to Cersil			1						1	Injection site erythema; Injection site hypersensitivity; Injection site pain; Pruritus	FLU3~SANOFI PASTEUR~U0882AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194140	11/27/2002	CA	73.0	73		F	11/18/2002	Excessive urination throughout the night-every 1-1 1/2 hr.									Y	11/06/2002	11/06/2002	0		OTH	OTH	Synthroid, Evista, Cozaar		Lactose intolerant, hypothyroidism, hypertension, scoliosis, osteoporosis, hives from some foods, food additives, allergic to pcn, aspirin, acidic foods will cause heartburn, osteoarthritis, anterior wall infarction (indeterminated) simpleR.			1						1	Pollakiuria	FLU3~SANOFI PASTEUR~U0919AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194178	11/27/2002	CA	56.0	56		F	11/27/2002	I felt perfect before I had flu shots in Clinic.  I started having flu symptoms such as soul throat. headache, muscle ache, short breath, cough, stuffing nose during the night. It has been already one week, still have not recovered yet. My husband had flu shot a month ago at same place, also afterwards had same symptoms as me. I had flu shots in the past years never had such sickness I'm wondering the quality of the flu vaccine.									N	11/21/2002	11/22/2002	1		UNK	UNK						1						1	Cough; Dyspnoea; Headache; Influenza like illness; Myalgia; Nasal congestion; Pharyngolaryngeal pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0194206	11/27/2002	MI	49.0	48		F	11/20/2002	Pain at inj site-radiating to back and down to elbow, continuing 27 days after inj. Tx-ice area, shower massage.				Y					N	10/24/2002	10/24/2002	0	NONE	OTH	OTH	Prilosec	NONE	NONE			1						1	Back pain; Injection site pain; Injection site pain; Shoulder pain; Tendonitis	UNK~UNKNOWN MANUFACTURER~U0928AA~UNK~~~VACCINE NOT SPECIFIED (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U0910AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0194210	11/27/2002	AZ	34.0	33		M	11/26/2002	11/16/02 seen in clinic for diarrhea, vomiting, jaundice, elevation of liver enzymes. 11/17/02 hospitalized for severe hypoxia, tachycardia, fever 104, rash, diarrhea. On ventilator for respiratory failure.			Y		Y				Y	10/16/2002	11/16/2002	31	Blood cultures negative, HIV negative, stool negative for shingella, salmonella and campylobacter, eelvated Igg for mycoplasma. *Follow-up received on 2/12/03: Hantauirus serology borderline high and is being repeated.	MIL	MIL		NONE	NONE			1						1	Diarrhoea; Hypoxia; Jaundice; Liver function test abnormal; Pyrexia; Rash; Respiratory failure; Tachycardia; Vomiting	FLU3~SANOFI PASTEUR~U0880AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|YF~SANOFI PASTEUR~UB171AB~2~SC~LA~YELLOW FEVER (YF-VAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0194212	11/27/2002	PA	34.0	34		F	11/27/2002	Left arm red swollen from shoulder to elbow. Area had multiple scattered raised papular rash. Low grade fever.				Y					U	11/19/2002	11/19/2002	0	none	PUB	PUB	none	none	none			1						1	Erythema; Oedema; Pyrexia; Rash papular	FLU3~PFIZER\WYETH~4020026~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0194213	11/27/2002	NM	58.0	58		F	11/27/2002	A flu and pneumonococoal vaccine were administered in the upper left arm on 11/13/02.  The arm became red swollen with pain.  Pt experiened a burning sensation from the elbow and up into my shoulder area.  Returned to the Dr. who administered the shot on 11/18/02 and was told that it was a reaction to the pneumonococoal vaccine.  The arm had developed a large bluish and odd yellowish white blister looking area.  Understand it was not a blister but sort of reminded me of what a small pox vaccine sort of looked like.  No culture was ever taken.  Pt was given an antibiotic and cortisone shot in the hips on this date and began taking 500 mg doses of Cephalexin orally.  Pt was to return on 11/20 for a follow up.  The arm continued to bother pt.  Pt returned to Dr. on 11/20.  Dr. said it looked better (to pt it did not).  Dr. said to return on 11/25 if not better and he would refer pt to a specialist.  Pt was feeling badly and explained this to him.  Pt had a headache and felt weak.  Pt told him pt didn't know if this was from the shots or if it was sinus.  He gave me alegra samples.  Pt felt very weak at this point and spend the day in bed after taking an Alegra tablet.  Arising once to eat some soup.  Around 4-4:30 p.m. Pt called his office to report that pt was really feeling badly.  Pt spoke with his medical assistant who had administerd the shot and again explaned I didn't know what it was but I just felt very very weak.  I was told by the medical assistant that I was thinking to much about the injections.  I assurd her that I would not bother them again.  The following day, I made an appointment at another medical clinic here and saw a CN.  She increased the Cephlaxen dosage to 4 times and instructed me to apply moist heat 3 times a day for about 30 minutes each time.  I was to return on Monday, 11/25.  The office receptionist informed me that the Dr. (CN) I had seen would not be there on 11/25.  So an appointment was made for 11/26.  On 11/25/02, I was feeling very - Nov 12. Called clinic regarding flu shot. I was told that they were only administered during times of the day, during the morning and early afternoon. At the time of my call deadline had already passed and I would have to go in the next day. Nov 13. I went to the clinic at the appointed time that morning. I waited but was told they could not administer the shot until a doctor was there. I was frustarted having taken off work. I waited but no doctor arrived so went back tothe office. When I returned, I signed a release form for the flu shot at the front desk. The copy was very poor and difficult to read. The MD's assistant called me to the pt lobby area. This is where the pts are weighted, temperatures and blood pressures taken before being put in a pt room. i was never placed in a pt romm and never saw a doctor. I thought this was odd since they made such a big deal about having a doctor there before they would administer the shot. The assistant asked if I wanted a pneumonia shot also. I said I had never heard of a pneumonia vaccine and yes, I also wanted it. She administered one shot (Iassumed the flu) vaccine in theupper left arm. She asked where I wanted the second shot. I replied I didn;t care, she said do you want in the same arm? I asked if this is okay and she said it didn't matter. So, I agreed to administer it in the same arm (thinking I would only have one sore arm instead of two). When I left I asked the young jokiingly, if I have a problem, who was I to see, the invisible doctor or who? She said herself. Nov 14-15 I began experiencing periodic burning from the elbow up into my neck area. This was pretty severe burning, the shot area became red, swollen, and hard. I got on the web and it appeared that these symptoms were normal and usually disappeared after a couple of days. on Thursday or Friday, the injection sites began to turn odd colors. A bluish area (like a bruise) appeared in what I think was the injection areas. A yellowish white bliste looking area appeared. It was not a blister but looked like one, it reminded me of a smallpox blister. on Saturday, the 16th, he injection sie was hurting and pretty sore and I decided I had better check with the doctor. I went to the clinic but it was not opened. Nov 18. I went to the clinic and said that I wanted to see a doctor, not one of his staff regarding my injection site. I saw a doctor and he looked at the arm said it was a reaction to the pneumonia shot and that he was going to report it. (I wondered how one could tell which shot the reaction could be from since they...should apply moist heat to the arm 3 times a day for about 30 minutes each time. She increased the Cephalexin to 4 times a day (2000mg/day). She wrote a new prescription for this increased dosage. I was to return to see her on Monday afternoon Nov 25. She would not be in that morning had another commitment. During this visit she explained that if the center of the inflamed area would soften up that it could be lanced but she felt that the body would just absorb the inflammation. A large are around the shot area was very hard to the touch. ...returned home and immediately called to see the doctor explaining that I was feeling weak and she had instructed me to see her that afternoon. She was in and they told me to come on out. Pt husband drove and I saw a doctor who said that the inflammed area had gotten bigger. She said she wanted another doctor to look at it. The doctor looked at it and he said he wanted another doctor to look at it. The doctor was not in and a second doctor looked at it. He said that the reaction could not be predicted. It was agreed that they would run blood work and refer me to a surgeon next door. The blood was drawn and the white count was very slightly elevated. The surgeon was called and he would see me right away. I left their office and went to the surgeons office. He used Novocain to deaden the area and removed the dark brown leathery scab. I was nformed that the wound would require a skin graft, once it was sufficiently healed. the wound was dressed and I was sent home and was to return the following day. Nov 26 Returned to doctor. He removed the dressing and showed me how to soak gauze pads in a saline solution and pack the wound. i was instructed to change the dressing 3 times daily. The wound is about 1 1/2 diameter circle and about 1/2 inch deep. I was to cleanse the wound with soap and water each morning. He wrote me a prescription for a bottle of the saline solution. He provided me with one bottle and a box of gauze pads. I followed these instructions dressing the wound about 4 times a day, since i found it would hurt when the dressing became dry. i was to return to his office on Friday, Nov 29. Nov 27 I awoke and removed the dressing and cleaned it. Some white fibrous tissue appeared to be forming on the wound. I didn't know what this was and decided to call and make sure it was not a problem. I called doctor's office and was told that this was fatty tissue forming and was normal. Nov 29 I returned to the doctor who asked if I was keeping the wound moist. He asked me how often I changed the packs. I said about 4-5 times a day. he said I should keep ot moist and to pay particular attention to the packing at night, since I would be asleep and it was the longest period when it was not receiving attention. He told me I could get more of the saline solution if neede. I left his office and got another bottle of the saline solution and more gauze pads. I was to return to his office on Monday. I made a real effort to insure the packs did not dry out over the weekend. Dec 2 Saw doctor today. He cleansed the wound of the yellow fatty tissue. Was not a very pleasant experience. but there is a good pink tissue beneath this fatty tissue. Arm pretty painful following the procedure. I am to return Wednesday and he will cleanse the wound. May be able to do skin graft end of the week. I asked how long it would be before I could drive off road on the job and he said likely another 7-10 days following the graft. Then would have to be careful not to pump the wound. Will have to wait and see. Dec 3 Arm very sore today. Took 800mg Ibuprofen 3 times for pain. Dec 4 Did not sleep well last night. Soreness got better as this day went on. Saw doctor at 2:30. He again cleansed the wound. Cleansing was much less painful today. He said graft would not be done this week, maybe next. I am to return home on Friday. Dec 5 Went to work at 12:30 today after being up all morning. Felt stronger today and yesterday afternoon as the day progresses. Starting feeling weak around 3:30, left office at 4pm. Had to drive car to dealer for recall repairs. Felt weaker and weaker. Came home dressed wound and went to bed around 5pm. Slept, awoke at 7:30 and was feeling very weak. Arm was hurting on the inside left, painfull to the touch. Stayed up in order to take the last dose of antibiotics. Awoke at 1:20 with bad headache. Took 800 mg ibuprofen typed on computer pretty much he entire 4 hours yesterday at work. Felt like muscle tension pain radiates up the arm across shoulder to my neck and into head. I've worked around 4 hours each day since Monday and have done okay. Returning home and resting in afternoon. Yesterday is the only day I have done so much typing at computer. Will talk to doctor about this tomorrow. Dec 6. No headache when I awoke. Worked morning. Visited doctor today. Temp 99.1. I told him about last night. he said he didn't know, maybe getting flu. I explained that I thought maybe was from working on computer. He said he would be glad to refer me to another doctor if I wanted. I didn't understand where he was coming from. I was just asking about the incident last night. I won't bring up any other questions to him. Can't understand this. He cleaned the wound today (no Novocain used). I am to return Monday. Dec 7-8 Weekend uneventful. Took it easy. Dec 9 First time doctor did not remove any fatty tissue from the wound. He said it was looking good, I was doing a good job in cleansing it. To return friday. Dec 9-10 Worked 8 hours and most of the day Tuesday. Left 45 minutes early on Tuesday, the wound hurting. Kept changing bandage more and keeping the woung moist. Finally, changed the bandage after going to bed earlier and was able to sleep through the night. Dec 11 Worked 8 3/4 hours today. Good day, wound only bothering when dressing dried out. Dec 13 Saw doctor today, arm ready for skin graft. To return on 12/17  Dec 17 Saw doctor, sent to hospital for some pre-ops tests. Dec 20 Entered hospital. Skin graft completed. took graft from upper thigh of left leg. Surgery done as an out-patient retumed home following surgery. Dec 23 Saw doctor, dressing left in place. i am to return on Dec 26. Dec 26 Saw doctor and he changed the dresing. Jan 1 Feeling better more like old self. Jan 5 Saw doctor and he released me. Feb 25 Wound continues to heal but gets these hard tissue areas that sort of split and bleed then disappear and another forms. this has gone on during the last month or so. So, I made an appointment to see a doctor. She says this is Keloid scarring and gave me steroid injections under the scar tissue. She explained I would likely have to return. She did not want to administer shots more frequently than 1 time a month. Wound is still healing. March 31 Arm seems to be better. Hard tissue is minimal now. i have an appointment with a dermatologist in April and think that there is not much more that can be done. Healing is much better than I ever thought possible.									U	11/13/2002	11/15/2002	2		PVT	UNK						1						1	Asthenia; Blister; Erythema; Headache; Oedema; Pain; Injection site necrosis	PPV~MERCK & CO. INC.~~1~~~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U0883AA  exp 06~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0445M  exop 03/~UNK~~LA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0194337	11/29/2002	IL	46.0			F	11/29/2002	8 days post-injection, developed shooting pains down left arm with tinglin sensation to fingers. Injection site soreness for 3 days.Induration but no erythema noted at injection site 11 days post-injection.									Y	10/28/2002	10/28/2002	0		PVT	PVT	none	none	none			1						1	Injection site induration; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U0935CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194338	11/29/2002	IL	51.0			M	11/29/2002	Experienced bilateral lower extremity weakness, mid-thigh down to feet, with numbness. No chills, no fever, no other bodyache. Restless and could not sleep that night.Symptoms resolved in 1 day. No injection site reaction									Y	10/28/2002	10/28/2002	0		PVT	PVT	none	none	none			1						1	Asthenia; Hypoaesthesia; Restlessness	FLU3~SANOFI PASTEUR~U0935CA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0178178	12/02/2002	PA	43.0	43		F	11/27/2002	Information has been received from a physician concerning a 43 year old White female EKG technician with an allergy to betadine who on 11/7/01 was vaccinated with the first dose of rubella virus vaccine live (second generation) (lot # 631088/0183K) in the left deltoid, and influenza virus vaccine (Fluzone) (lot #U0669AA) in the right deltoid. Concomitant therapy included diphenhydramine (Benadryl), vitamins, and estrogens, conjugated (Premarin). The patient had no illness at the time of vaccination and no prior history of reactions to vaccinations. On the evening of 11/7/01 the patient developed fever of 103 degrees F. The patient also developed diffuse itchiness that was reported to be in a symmetrical pattern. The itching involved the axilla region in the upper extremities. The patient noted the onset of a red, well-defined erythematous, raised lesion that had persisted. The area was quite itchy and extremely sensitive to water or any type of irritating substance. Within a few days, the patient also experienced some itching on her chest and legs. She noted some erythema on her left leg that had resolved. The patient had some chest tightness which had also improved. The patient reported no lip or tongue swelling, periorbital edema, or dyspnea. The patient had no coughing. The patient reported that the itching was quite severe and she used diphenhydramine (Benadryl) without relief. The patient was also noted to have malaise and a decreased appetite. There was no nausea or diarrhea. On 11/14/01 the patient was seen by a physician in the occupation health center and upon examination, the patient's vital signs revealed a blood pressure of 106/70 mm/HG, heart rate of 84, respiration rate of 18, and a temperature of 97.9.  The patient's torso showed a large erythematous rash that was raised in both axilla regions. her skin appeared raw and there was no evidence of any type of urticarial type reactions elsewhere. The rash was felt to be contact dermatitis. Inspection of the remainder of the upper extremities and lower extremities showed no other rash-like lesions. It was also reported that the patient had complaints of chills. The patient was placed on therapy with citirizine hydrochloride (Zyrtec), hydroxyzine hydrochloride (Atarax), and was to use cool compresses or burrow compresses to the axilla region and was to use a mild soap and an oil-based moisturizer, and avoid any type of deodorant. On 11/20/01 the patient reported an overall improvement. She had a moderate reduction in the itching and stated that the rash had nearly resolved. The patient noted that there was some dryness at the location and reported that she was using a mild soap and an oil-based moisturizer. She had not resumed the use of deodorant. There was no new rashed at that time. The patient reported diffuse arthralgias which responded to ibuprofen (Motrin) and reported episodes of elevated temperature including 11/19/01. She was continuing therapy with cetirizine hydrochloride (Zyrtec). Inspection of the patient's back showed resolution of all rashes. Inspection of the axilla showed resolution of the red raised lesions and there was some dryness of the skin but no new lesions were noted. Therapy with cetirizine hydrochloride (Zyrtec) was discontinued and the patient was to resume the use of deodorants and use ibuprofen (Motrin) as needed. On 11/27/01, the patient presented to her physician with complaints of arthralgias (from 11/14/01) and myaglias and general malaise. The patient reported that on 11/24/01 she developed diarrhea, and that on 11/26/01 she developed redness along the palmar aspect of both hands along with diffuse arthralgias involving the PIP and MP joints of both hands, more prominent on the left wrist, elbows, knees, and ankles. The symptoms appeared worse on the left than the right. There was also diffuse muscle ache, general malaise, and upper abdominal chest pain. The patient denied chills. The patient's temperature was approximately 101. The patient reported no itching at that time, however reported having bluish discoloration of the left eye with frequent episodes of the eye watering and burning. At that time the patient reported no recurrence of skin rashes. The patient did however report that her hands felt swollen. Inspection of the hands no loss of architecture. Vital signs at that time revealed a temperature of 97.9, respirations of 18, an unlabored pulse of 72. Inspection of the face showed no facial erythema or edema including periorbital edema. There was no discoloration of the eye. Inspection of the oropharynx showed no discoloration, exudates, or erythema. The neck was supple without any adenopathy or JVD and her lungs were clear. Inspection of the back showed no rashes, and inspection of the hand showed a diffuse erythema. There was tenderness to palpitation over the left MP and PIP joints. There was tenderness involving the left wrist and elbow. No crepitus was noted. There was diffuse myalgias invovling the upper extremities and tenderness to palpitation of the abdomen but no rebound or guarding. Examination of the extremities showed no petechiae, edema, or erythema. There was minimal tenderness over the knee and ankle joints. The patient was instructed to resume therapy with cetirizine hydrochloride (Zyrtec), and to continue use with acetaminophen (Tylenol) and ibuprofen (Motrin). On 12/4/01 the patient was seen in the occupational health center concerning her diffuse symmetrical arthralgias involving her hands, upper extremities, and lower extremities. It was reported at that time that her personal physician had placed her on therapy with prednisone on 11/30/01. Laboratory findings from 11/27/01 were reviewed and showed a sedimentation rate of 14, a negative rheumatoid factor, C1, estrace inhibitor 15 normal, ANA negative, and C3 121 and C4 16.8 both considered normal. At the time of the 12/4/01 visit, the patient reported generalized stiffness in the morning upon awakening. She had difficulty getting out of bed but improved with activity. She noted significant pain and stiffness involving her hands with difficulty using her hands for any type of forceful repetitive motion. She stated though that activity decreased the pain. She still had arthralgias involving the elbows, knees, and ankles which was most pronounced after resting. She noted a response to the acetaminphen (+) hydrocodone bitartrate (Lortab) that she had been prescribed. She denied any fever or chills and her swelling had slightly gone down. She reported no other symptoms at that time. Inspection of the patient's hands showed some slight fullness but no loss of architecture. There was tenderness to palpitation over the MP and PIP joint and full range of motion of the knees. The patient was prescribed rofecoxib (Vioxx) 50mg for four days, then 25mg, acetaminophen (+) hydrocodone bitartrate (Lortab) and therapy with prednisone was discontinued. The patient was placed on senna for constipation (incidental finding) that was considered to be secondary to acetaminophen (+) hydrocodone bitartrate (Lortab). On 12/10/01, the patient presented back to the occupational health center at the request of her supervisor due to concerns of functional difficulty. The patient reported no overall change at that time, however she reported that she had recently experienced diffuse arthralgias and myalgias involving the right upper extremity extending from the scapula to the head. She reported having swelling in the hand and she was unable to tightly grip, grasp, or perform any type of fine activity. She also reported having difficulty sleeping at night. The patient was continued on her medication treatment regimen, however, reported some gastrointestinal discomfort. She stated that acetaminophen (+) hydrocodone bitartrate (Lortab) helped the pain but made her goofy. Upon physical examination, the patient was in mild discomfort. She had a flat affect but no guarding. Inspection of the right hand showed slight fullness but no significant loss of architecture. There was tenderness to palpitation along the right scapula and right rotator cuff, right bicep belly, the elbow, the right forearm including the flexor and extensor muscle, the wrist, and the MP and PIP joints. The patient had decreased power grip and hook grip on the right. Therapy with rofecoxib was discontinued and the patient was palced on celecoxib (Celebrex), lansoprazole, tramadol hydrochloride, and tizanidine hydrochloride. The patient was removed from patient care activities and also from motor tasks that required fine or repetitive gripping of the right hand. Occupational therapy with aqua therapy was continued. At the time of this report, the patient had not recovered. Upon internal review, the events of arthralgia and myaglia were considered to be other important medical events. (OMIC) No further information is available.				Y					N	11/07/2001			Blood pressure 106/70mmHG; Urinalysis - trace ketones , SC 1.025, pH 6.5, Urobil 0.2 eu/dl, crystals: 1+ amorphous urates; Aytpical Lymphocyte - 0.12x, 1.7%; Basophil count 0.05x, 0.7%; Eosinophil count 0.13x, 1.9%; Hemoglobin 12.6 gm/dl; Component C1-INH Test 15 mg/dl; RDW 12.6%; RBC 4.26x; Mean platelet volume 10.4 fl; Mean corpuscular volume 86.5 fl; Mean corpuscular 34.2 g/dl, 29.6pg; Erythrocyte 14 mm/hr; Component C4 test - 16.8 mg/dl; Component C3 test 121mg/dl; Hematocrit 36.9%; WBC count 6.78x; Pulse rate 72; Respiratory rate 18; Pulse rate 84; Temperature measurement 103F, 97.9F, 101F, 97.9F; Serum rheumatoid factor negative; Serum immunoglobulin Rubella AB; Serum ANA negative; Lymphocyte count 1.79x, 26.4%; Monocyte count 4.5%, 0.31x; Neutrophil count 4.40x, 64.8%; Platelet count 211x	PVT	PVT	Benadryl, Premarin, Vitamins		Specific allergy (drug)		WAES01120238	1						2	Abdominal pain; Arthralgia; Chest discomfort; Chest pain; Chills; Conjunctival discolouration; Decreased appetite; Diarrhoea; Erythema; Eye irritation; Hyperaesthesia; Insomnia; Lacrimal disorder; Malaise; Myalgia; Pruritus; Pyrexia; Rash; Skin ulcer; Swelling	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|RUB~MERCK & CO. INC.~0183K~1~~~RUBELLA (MERUVAX II)~2	USA	Emergency room visit	Influenza
0191997	12/02/2002	WV	33.0	33		F	11/29/2002	Lost vision right eye, treated with 8 day course of tapering prednisone.									Y	10/15/2002	10/15/2002	0		PUB	PUB						1						2	Blindness transient; Blindness	FLU3~SANOFI PASTEUR~U0966BA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~40966BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0194225	12/02/2002	NY	77.0	77		M	11/18/2002	Brochial plexus neuropathy R arm started 6 hrs after injection and now 3 weeks later, has pain, weakness in hand grip and resolved sensation.  Seeing neurology for nerve conditions studies.  Follow-up information received on 3/4/2003 states; slight imporvement.  Still a lot of arm, wrist and hand pain and swelling. Follow up on 01/14/04: Vaccine recipient did not recover from the adverse events that were reported for this vaccination.  Diagnosis: Brachail neuritis, still with numbness right hand and fingers, symptoms unchanged.								Y	N	11/01/2002	11/01/2002	0		PVT	UNK	Metformin, Glucotrol XO, Monopril, Verapamil, Prazocin, HCT 2	NONE	NONE			1						1	Muscular weakness; Neuropathy; Pain	FLU3~SANOFI PASTEUR~U0909AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0194227	12/02/2002	WI	76.0	76		F		Severely fluctuating blood pressure, chills, heart rhythm irregularities, muscle weakness, numbness face, hand, arm than legs-pins-needle sensation-then stiffness-paralized flu shot at 8a, appt-symptoms hit within 10 mins. Drs. felt I was having a heart attack or stroke-BP hitting 198/100 and more-had CAT scan, MRI-ruled out, heart tests, blood tests, symptoms stayed-told to rest take it easy.				Y	Y	3			Y	10/30/2002	10/30/2002	0	CAT scan, MRI-ruled out, heart tests, blood tests	PVT	UNK						1						1	Blood pressure increased; Chills; Heart rate irregular; Hypoaesthesia; Joint stiffness; Muscular weakness; Pain; Paralysis	FLU3~SANOFI PASTEUR~U0934GA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0194229	12/02/2002	OR	26.0			F	11/25/2002	Pt red'd flu vaccine which caused a local reaction in her arm She denies being allergic to eggs. She is currently being treated for an abcess in her arms with antibiotics. She does not have a rash or edema. The patient is a 26-year-old woman with Devic's disease who experienced recurrence of right-sided weakness and paresthesia with severe weakness of the right leg of new onset and exacerbation of right optic neuritis with loss of vision in the right eye.  This was temporarily associated with the development of an area of erythema and tenderness consistent with cellulitis at the site of recent immunization in the right deltoid.  The patient is on immunosuppresant therapy with chronic prednisone, recent courses of high-dose methylprednisolone, and mitoxantrone treatment.  In spite of this rather aggressive treatment, she has had problems with recurrent bouts of myelitis everytime that her steroids have been reduced.  Because of the cellulitis and her worsened symptoms, she was admitted for evaluation and treatment.  The patient received an initial dose of methylprednisolone given the appearance of cellulitis with possible abscess.  Attempts were made to obtain culture by needle aspiration.  There was no discrete fluctuant mass, however and no pus could be obtained in spite of an area of considerable swelling and erythema.  Ultrasound did not demonstrate an abscess.  Cultures were negative.  Treatment with high doses of intravenous antibiotics eventually resulted in the marked improvement.  This took several days in spite of the 250-mg dose of methylprednisolone that she received initially.  Because of the possible effects of her multiple sclerosis and her recalcitrant course, famciclovir and atorvastatin were begun.  The patient was discharged on these medications, in addition to her usual prednisone and an oral course of ceftriaxone and metronidazole.  The patient was to return to clinic for outpatient followup.  Annual follow up on 12/23/03, 12/24/03:  (Completed by) person is not known to hospital.					Y				U	11/19/2002	11/22/2002	3		OTH	OTH	UNK	UNK	Pt has multiple sclerosis			1						1	Blindness; Cellulitis; Injection site abscess; Myasthenic syndrome; Paraesthesia	FLU3~SANOFI PASTEUR~UO875AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0675m~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0194231	12/02/2002	CA	52.0	52		M	11/21/2002	52 year old male received flu shot 11/9/02. 11/14 developed fever, chills, flu like illness. 11/15 developed abnormal mental status. On 11/15 he was admitted to hospital for encephalitis; etiology unknown. Possible adverse reaction. A 60-day follow up report received 6/10/2003 adds no new info.  Annual follow up on 03/17/04: It is unknown if the pt recovered from adverse events.			Y		Y				U	11/09/2002	11/14/2002	5	11/15 CSF glucose 70 protein 123, 15 WBC, ORBC 50c 50m. Cultures negative C95, AFB, farci pending. 11/16 HSV 1 & 2 PCR negative. 11/16 varicella PCR pending. 11/15 urine tox screen negative. 11/15 CATS nl	UNK	UNK						1						1	Chills; Encephalitis; Influenza like illness; Mental impairment; Pyrexia	FLU3~EVANS VACCINES~E34702HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0194240	12/02/2002	VA	54.0	54		F	11/19/2002	c/o painful right upper arm x 2 weeks. Pain began after flu shot and continues with decrease use of right limb (only due to pain). requires assistance dressing and other activities. Pt tried aspirin x 3 days no help Adv: heat, advil. See PMD if sx persist. States  no swelling or discoloration at sit (right arm). Has full range of motion, normal tempature normal use of hand/ fingers.									N	11/05/2002	11/05/2002	0		PUB	PUB	Zintec- Lisinopril	NONE	Increase Blood Pressure		VA02038	1						1	Hypokinesia; Pain	FLU3~PFIZER\WYETH~4020021~3~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0194241	12/02/2002		88.0	88		M	11/20/2002	Received vaccine on 11/12. Reported evening of 11/13 a rash. Reported to provider on 11/14. Rash on both legs, no temperature, no itching or swelling.										11/12/2002	11/12/2002	0		UNK	UNK						1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0194259	12/02/2002	FL	33.0	33		M	10/11/2002	Vomiting, diarrhea, nausea, general aches 1 day following flu shot/ anthrax vaccination (possible reaction) IV fluid administered / toradol given improvement.				Y					Y	10/09/2002	10/10/2002	1	BMP - normal	MIL	MIL			HTN			1						1	Diarrhoea; Nausea; Pain; Vomiting	ANTH~EMERGENT BIOSOLUTIONS~~UNK~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0194260	12/02/2002	PA	35.0	35		F	11/26/2002	I first felt swelling and burning in my left arm the next day. On Saturday 11/9/02, I experienced severe nausea, vomiting and diarrhea till 11/16/02. I also had hives, dizziness and weakness. I went to my doctor and they stated I had a reaction to the flu shot and that I was dehydrated. I also had a high temperature. On 11/22/02 I was take to the ER with the same symptoms. The ER took blood work. Again I was told I was dehydrated. I needed two IVs and Phenaphen at the ER on 11/22/02. I was sick for 16 days.				Y					Y	11/07/2002	11/08/2002	1		UNK	UNK		NONE	Allergies to sulfa drugs; fibromyalgia			1						1	Asthenia; Dehydration; Diarrhoea; Dizziness; Nausea; Oedema; Pain; Pyrexia; Urticaria; Vomiting	FLU3~EVANS VACCINES~E37202~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0194261	12/02/2002	NM	38.0	38		F	11/04/2002	Left axillary tenderness, onset 24 hours after injection, persisting now for 3 days.									U	10/31/2002	11/01/2002	1	NONE	PVT	UNK		NONE	Hashimoto Thryroiditis			1						1	Tenderness	FLU3~SANOFI PASTEUR~U0971AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194262	12/02/2002	WY	71.0	71		F	10/23/2002	About 4 hours after receiving Pnuemonia vaccine, patient's left deltoid started to hurt and she took Ibuprofen. Area from left elbow to left breast nipple line became progressively red, puffy and sore. After 24 hours area started to itch and redness faded. Did not notify doctor or seek medical treatment.									Y	10/18/2002	10/18/2002	0		OTH	PUB		NONE	NONE			1						1	Erythema; Pain	FLU3~PFIZER\WYETH~4020024~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0995L~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194263	12/02/2002	WY	67.0	66		F	11/01/2002	Left arm began to ache that afternoon as if it would fall off. By 9pm discovered that arm was hot, red, swollen - went to ER - received IV antibiotics, discharged around midnight - sent home on Augmentin for 6 days.				Y					Y	10/17/2002	10/17/2002	0		PUB	PUB		NONE	HTN - takes Inderne, HCTZ, Synthroid,			1						1	Oedema; Pain; Vasodilation procedure	FLU3~SANOFI PASTEUR~U0919AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0541M~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0194265	12/02/2002		31.0			M		A report was received from a regulatory authority on 11/18/02, concerning a 31 year old male vaccinee who experienced headache, collapse, and neck pain which were considered to be medically significant, 2 minutes after receiving the Fluvirin vaccine on 10/11/02. The patient had no known allergies and no known previous adverse reactions. On 10/11/02, the vaccinee collapsed within 2 minutes of receiving the Fluvirin vaccine and injured himself in a fall. Since then, the vaccinee has had persistent occipital headaches and some pain on moving his neck, especially rotation to the right. He had a week off work and has received treatment with non-steroidal anti-inflamamatory drugs. The headaches and the pain on movement have considerably improved. There was insufficient information to determine the reporter's causality assessment.										10/11/2002	10/11/2002	0		UNK	UNK					PJP200200788	1						1	Headache; Loss of consciousness; Neck pain	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0194266	12/02/2002		76.0			F		A report was received from a health care professional on 10/25/02, concerning a vaccinee of unknown demography who experienced short term memory loss, two hours after receiving Fluvirin IM in 10/02. It was reported initially on 10/25/02 that in October,2002, the vaccinee experienced memory loss for approximately 24 hours after receiving 0.5ml Fluvirin IM in October, 2002. The symptom was reported to be self-limiting'. It was reported that the vaccinee did not receive medical intervention and recovered without sequelae. follow-up information received on 11/06/02;an addendum was received which reported that the vaccinee was a 76 year old female who was vaccinated on 10/19/02 with Fluvirin (batch # E34692HA) and experienced short term memory lose for two days and injection site local reaction of pain, redness and swelling and had resolved within 2 days of onset. All symptoms were self-limiting. On an unknown date, the vaccinee was admitted to hospital due to memory loss and underwent a MRI examination, the results of which were found to be normal. The reporter did not have information on the past medical and drug history of the patient. There was insufficient information to determine the reporter's causality assessment.  Follow up on 12/23/2002: Follow up information received on 12/11/2002: a follow-up was received which reported that the vaccinee experienced stinging when she received the vaccine followed later by pain in the right arm.  The redness was the size of a jar lid/large lump.  It was also reported that the redness and swelling lasted for 7 days and the vaccinee was hospitalized for 3 days.  It was reported that no other medical diagnosis was made and the vaccinee has had no symptoms since.  The outcome was reported as resolved.  The batch number has been confirmed as E3469244A and not E24692MA as previously reported which is not identified as a batch number.  It was reported that the vaccinee had a previous incident of memory loss following pneumovax administration.  The reporter did not have information on drug history of the patient.  There was insufficient information to determine the reporter's causality assessment.					Y					10/19/2002	10/19/2002	0		UNK	UNK					PJP200200655	1						1	Amnesia; Injection site erythema; Injection site pain; Injection site swelling	FLU3~EVANS VACCINES~E34692HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0194267	12/02/2002	OH	72.0	72		F	11/13/2002	Client here complaining of left arm pain which continues since she received her influenza vaccine on 10/16/02. Client states that immediately at the time of the shot, she felt a strong pressure all the way down her arm to her wrist. The pressure quickly started leaving, but the pain continued at the site, radiating down to her wrist. Client discussed it with doctor on Thursday, while in the office for a routine visit. He advised client to apply hot compresses to the site, but to continue to use the arm like normal. Client states she discontinued using hot compresses after 2 days, but the pain continued to radiate down to the wrist for 2 weeks. At present, client states that she still has stabbing pain at the injection site, which radiates down to her elbow, when she raises her left arm or moves it into certain positions. The pain no longer extends to the wrist. Client indicates a spot on her left, uppar arm, about 2 fingerbreadths below the acromion process as the still painful, injection site. No redness, bruising or swelling noted at this time. Advised client to follow up with her family doctor if pain continues.										10/16/2002	10/16/2002	0		PUB	PUB		NONE	Chronic bronchitis; Allergies; Asthma			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U0905FA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194268	12/02/2002	MI	67.0	67		F	11/21/2002	Left arm became swollen, red, and sore 2 hours after getting Pneumonia shot--no trouble breathing pain controlled with Tylenol and ice to injection site.									Y	11/15/2002	11/15/2002	0	NONE	PVT	PVT		NONE	NONE			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~EVANS VACCINES~E35732HA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0172M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194269	12/02/2002	ID	36.0	36		F	11/22/2002	Patient said she felt weak for 30 seconds and then passed out and them came to. This occurred 12 hours later. Didn't go to ER.									Y	11/08/2002	11/08/2002	0	NONE	OTH	OTH		NONE	NONE			1						1	Asthenia; Loss of consciousness	FLU3~SANOFI PASTEUR~U0952AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194270	12/02/2002	NC	53.0	53		M	11/22/2002	Elevated BP. Normal prior to shot; detected elevated day after shot. Values have ranged from 170/90 to 208/110. Norvasc prescribed on 11/20/2002. Moderate edema of face and neck. Lasted about 5 days. Excess gas, flatulence. Lasted about 5 days. Shortness of breath, decreased ability to exercise. Symptoms reduced considerably over 5-10 days.				Y					U	11/12/2002	11/13/2002	1	BP elevated.	PUB	PUB	Bextra; Oral Allopurinol; Testosterone	NONE	Gout; hypogonadstrophic hypogonadism; Cervical arthritis			1						1	Blood pressure increased; Dyspnoea; Face oedema; Flatulence; Swelling	FLU3~SANOFI PASTEUR~U0933AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0194272	12/02/2002	WY	48.0	48		M	11/16/2002	I received vaccine at 2:45 PM at my jobsite and at approximately 9:00 PM, I began to get chills and at 11:00 PM took my shower at the end of my 8 hour shift and had chills while taking hot shower. I arrived home at 11:45 PM on evening of 11/07/02 and was extremely chilled and short breathed and wrapped up in blankets and went to bed and woke up approximately 7:00 AM on morning of 11/8/02 and was soaked from sweat and had severe headache.									Y	11/07/2002	11/07/2002	0		OTH	OTH	NONE	NONE	One kidney has low function.			1						1	Chills; Dyspnoea; Headache; Hyperhidrosis	FLU3~SANOFI PASTEUR~U0940AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194273	12/02/2002	UT	55.0	55		F	11/20/2002	Within 24 hours, arm became very painful and swollen. Thought she had fever, then developed redness around injection site that spread to cover most of upper arm; very warm and painful for four days.									Y	11/15/2002	11/16/2002	1	NONE	PVT	PVT	Premarin, Protonix, Allegra	NONE	Cardiac arrythmia with pacer; Elevated lipids, II Melanoma			1						1	Feeling hot; Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U0875AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0820M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194274	12/02/2002	WI	60.0	60		F	11/20/2002	Left arm swollen and itchy at injection site. She is diabetic. Now blood sugars are out of control. Has red area 3-4 inch diameter on arm. Used ice and ibuprofen.				Y						11/12/2002	11/13/2002	1		PUB	PUB	UNK	IDDM				1						1	Blood glucose increased; Erythema; Injection site hypersensitivity; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U0886AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0817AA~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0194275	12/02/2002	WI	0.75	0	.8	M	11/19/2002	Influenza vaccine given 11/14. That night had fever 104.05 and extreme irritability 11/15. Still very irritable; no fever.									Y	11/14/2002	11/14/2002	0	NONE	PVT	PVT	Advil	3 days of URI; Temperature of 100.6; Irritable	NONE			1						1	Irritability; Pyrexia	FLU3~SANOFI PASTEUR~U0354AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194276	12/02/2002	MD	44.0	44		F	11/25/2002	Marked cellulitis L arm.									Y	11/21/2002	11/22/2002	1		PVT	PVT		NONE	Asthma			1						1	Cellulitis; Injection site reaction	FLU3~EVANS VACCINES~31862GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0541M~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194277	12/02/2002	MA	51.0	51		F	11/21/2002	Circumscribed area on left deltoid at shot site location-center of area dark purple surrounded by red area, raised, warm to touch. Occurred within 3 hrs. No fever noted. Gradually subsided over 1 week period.									Y	11/14/2002	11/14/2002	0	NONE	OTH	PUB	Asthmacor, Zythromax, Nasalcort, Zoloft	Recovering from sinus infection	Lupus			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U0969AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194278	12/02/2002	MD	73.0	73		F	11/18/2002	Client states she got hives from head to toe early Thursday morning 10/31/02. She went to family physician. He gave her a shot and prescription for steroid pack. She began to feel fine on second day. Symptoms disappeared by third day.				Y					Y	10/30/2002	10/31/2002	1	NONE	OTH	PUB	Estradid; Lipitor; Atenolol; Zestoretic	NONE	NONE			1						1	Urticaria	FLU3~PFIZER\WYETH~4020022~7+~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0194279	12/02/2002	MD		13		M	11/25/2002	Cellulitis right arm.									Y	11/21/2002	11/22/2002	1	NONE	PVT	PVT	Albuterol	Pharyngitis/Epistaxis	Asthma			1						1	Cellulitis	FLU3~EVANS VACCINES~E318626A~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0541M~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194282	12/02/2002	NH	30.0	30		M		Constant headache, fever, shakes, disoriented, dry mouth, watery/itchy eyes. Started 2  days after shot.										11/04/2002				PVT	PVT		NONE	No egg allergy; No reaction to vaccine 2001			1						1	Disorientation; Dry mouth; Eye irritation; Headache; Lacrimation increased; Pyrexia; Tremor	FLU3~EVANS VACCINES~E55492KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0194283	12/02/2002	NC	71.0	71		M	11/19/2002	Around 11/13 developed hives on body, arms, and legs. itching and swelling in mouth. This condition improved and worsened till 11/19 when it was worse and he saw doctor. Was given Zyrtec and condition improved after 1 dose. His HCTZ and baby ASA was also stopped at that time.				Y					Y	10/30/2002	11/13/2002	14	NONE	PUB	PVT	Baby aspirin, HCTZ, Irbesartan, Simvastatin, Atenolol; Metformin, Glipiside, Nifedipine, Vitamin E; Multivitamin; Cilostazol	NONE	Elevated BP; Elevated Cholesterol, heart problems; Niacin allergy; angioplasty; aneurysm.		NC02116	1						1	Pruritus; Swelling; Urticaria	FLU3~SANOFI PASTEUR~U0925AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0194284	12/02/2002	OH	58.0	58		M	11/25/2002	Nausea, muscle aches, chills, lightheadedness, flushing (warm) feeling, headache, increased heart rate. Intermittent and varying symptoms for the last 18 days.				Y					N	11/07/2002	11/08/2002	1	EKG and Blood tests normal.	OTH	OTH	Accupril, Cardura, Proscar	NONE	Hypertension, Benign Prostate Hyperplasia			1						1	Chills; Dizziness; Flushing; Headache; Heart rate increased; Myalgia; Nausea	FLU3~SANOFI PASTEUR~U0922AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0194285	12/02/2002	MA	38.0	38		M	11/22/2002	Received flu vaccine in left deltoid muscle at approximately 2:30 PM. At approximately 3:25 PM, reported red spots and itching of both arms. Minimal site swelling (approximately 3cm), non raised rash on inner right antecubital area and similar on left arm. Denied difficulty breathing. Benadryl 25mg given with resolution of rash in 40 minutes. BP and P stable. BP 150/100 and Pulse 68.									Y	11/21/2002	11/21/2002	0	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Erythema; Injection site swelling; Pruritus; Rash	FLU3~SANOFI PASTEUR~U0931AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194286	12/02/2002	PA	51.0	61		F	11/14/2002	Client presented to nurse requesting explanation of redness on left arm. She also expressed concern about the use of sterile needles in clinic environment. RN observed client's left deltoid area, where she had received flu vaccination two days earlier on 11/12/02. Site was notable for an erythematous area that was warm to touch. There was not swelling or discharge. Area was approximately 1.5 below injection site, and approximately 2x4 wide with an irregular border. Client denied pain or discomfort and stated I'm not so worried about my arm, but whether or not you used sterile needles. Nurse explained use of Universal Precautions to client. Client was advised that she could have a local reaction to vaccine. She reported that she didn't think it was necessary to see a doctor, and just needed to be assured that sterile technique and Universal precautions were used. Nurse offered reassurance, education and counseling to client. Client was advised to apply cold compresses to site and return for observation tomorrow. Client appeared to be without distress when she left. Client presented to nurse this day for observation of injection site on left deltoid. Client reports she applied cold compresses last night that provided some relief. Client also stated she thought site looked less red and denied pain or discomfort. RN observed client's left deltoid area. Site was found to be cool to touch, redness was present but diminished and more diffuse. No swelling or discharge was noted. Area now appearing as pink band with irregular border, beginning approximately 1.5 below injection site and approximately 3x5 wide from lateral aspect to posterior aspect of left upper arm. Client denied pain or discomfort. Client requested reassurance again from nurse regarding sterile technique. Nurse provided education regarding Universal Precautions and the transmission of HIV virus. Client stated she was relieved and felt better and appeared without distress when she left.										11/12/2002	11/12/2002	0	NONE	PUB	UNK	Synthroid	NONE	Hypothyroidism			1						1	Feeling hot; Injection site erythema	FLU3~PFIZER\WYETH~4020026~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0194287	12/02/2002	VI	65.0	65		M	11/21/2002	Left deltoid with edema, painful, and tender to touch. Duration approximately 3 days, fever and chills. Client start analgesics and Panadol. Used cold compress and alcohol solution.									Y	11/15/2002	11/15/2002	0	NONE	OTH	PUB			NONE			1						1	Chills; Oedema; Pain; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~U0881AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0358M~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194288	12/02/2002	CA	26.0	25		F	11/21/2002	Bruised site 1.75 within 48 hours. Hot to touch, painful and burning for 3 days. Slightly raised and in perfect circle. ER visit x 2 for check up and pain medication. Increased to 3 diameter. 11/21/02 resolving with pain and is itchy.				Y					Y	11/15/2002	11/16/2002	1	NONE	PUB	PUB	Prevacid; Metronadazole	Allergy; H-Pyloric bacteria in stomach				1						1	Contusion; Feeling hot; Injection site swelling; Pain; Skin burning sensation	FLU3~SANOFI PASTEUR~U0885~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~M0541~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0194306	12/02/2002	CA	0.5	0	.5	M	11/27/2002	Per mom, child given DTaP, IPV, Comvax, Flu and Prevnar and had redness on 11/25/02. Later that day temp increased 102.5 and has been up and down all night and day. Today noted that area LVL inj where flu vacc given with induration.				Y					Y	11/25/2002	11/25/2002	0		PVT	PUB	NONE		URI	Erythema~DTaP (no brand name)~1~0.25~In Patient		1						1	Injection site erythema; Injection site induration; Pyrexia	DTAP~SANOFI PASTEUR~U0583AA~2~IM~RL~DTAP (TRIPEDIA)~1|FLU3~PFIZER\WYETH~4020034~1~IM~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HBHEPB~MERCK & CO. INC.~1392L~2~IM~RL~HIB + HEP B (COMVAX)~1|IPV~SANOFI PASTEUR~U1645~2~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~489838~UNK~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0194307	12/02/2002	CA	1.0	0	1	M		Gave SQ MMR and within 5-10 min, noted 1 x 3 induration/erythema.				Y					Y	11/25/2002	11/25/2002	0	NONE	PVT	PUB	None	None	Amoxicillin			1						1	Injection site erythema; Injection site induration	FLU3~PFIZER\WYETH~A020C84~1~IM~LL~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|HBHEPB~MERCK & CO. INC.~1392L~3~IM~RL~HIB + HEP B (COMVAX)~1|IPV~SANOFI PASTEUR~U1645~3~SC~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0545M~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~4893838~3~IM~LA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0194308	12/02/2002	WY	50.0	50		F	11/07/2002	Large (grapefruit sized) local redness which spread to elbow and chest. Joint soreness. Elbow and shoulder. Fever 101 degrees. did not see phy. Taking Benadryl, Ibuprofen and cold packs (feel better than warm packs).									Y	11/05/2002	11/05/2002	0	NONE	PUB	PVT	UNK	NONE	Asthma, pneumonias		WY0213	1						1	Arthralgia; Injection site erythema; Pyrexia	FLU3~SANOFI PASTEUR~4020028~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1353L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194310	12/02/2002	WY	66.0			F	10/24/2002	Swelling, redness on inner aspect of R arm. Redness had a streking effect to it.				Y					Y	10/21/2002	10/23/2002	2	NONE	PUB	PUB		NONE			WY0217	1						1	Injection site erythema; Injection site oedema	FLU3~PFIZER\WYETH~4020027~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~476954~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0194311	12/02/2002					U		Celulitis of left arm (shoulder to wrist).				Y					U	11/14/2002	11/16/2002	2		UNK	UNK			Heart murmur			1						1	Cellulitis; Injection site reaction	FLUX~UNKNOWN MANUFACTURER~4020008~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0194340	12/02/2002	PA	1.5	1	.5	M	11/27/2002	Temperature developed with temperature max of 105.4 and then febrile seizure x 2 on 11/23/02. Seen in ER and subsequently admitted. Febrile until 11/25. (unknown)LOM; (unknown) Pharyngitis. Medical records state otitis media, and pharyngitis.				Y	Y	3			Y	11/22/2002	11/22/2002	0	CBC, Blood culture, LP with CSF Cx; Catheritized;Lab test abnormal	PVT	UNK		NONE	NONE			1						1	Febrile convulsion; Laboratory test abnormal; Otitis media; Pyrexia	DTAP~SANOFI PASTEUR~C0813AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U0904CA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0194343	12/02/2002	FL	27.0	27		U		Started feeling a little sick on 11/28. Missed one day of work. Still recovering from flu.									Y	11/25/2002	11/28/2002	3		UNK	UNK						1						1	Influenza; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0194352	12/02/2002	CT	63.0	63		F	11/26/2002	Information has been received from a registered nurse concerning a 63 year old white female with diabetes mellitus and allergies to codeine and IPV dye who on 10/23/02 was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent in the right deltoid (lot 642749/0111M). On 10/25/02, the pt developed an area of redness at injection site that was hot from the top of arm to elbow. The pt was unable to move her arm. She also developed a fever, nausea and a headache. The pt was treated with Medrol.  It was reported the pt had a severe headache and her face was flushed from the methylprednisolone which stopped after 2-3 days. Additional info was received from the nurse and an ER report. The nurse reported that on 10/23/02, the pt's right arm was red and swollen. On 10/25/02, the pt contacted the office and reported that the pt's arm was swollen, red, and painful. The pt was told to go to the ER. The ER report indicated that in the ER, the pt denied any fever or chills. On the left arm, there was an area of erythema measuring 10cm x 8cm of the left arm. There was swelling with pain on movement of the left arm. The pt had an IV established and was given Rocephin 1g. It was reported that the pt did receive a flu shot on 10/23/02. The pt's symptoms were thought to be a localized reaction versus early cellulitis. The pt was treated for presumed early cellulitis and sent home. The nurse reported that the primary care nurses in the practice always administer the pneumococcal vaccine in the right arm and the influenza vaccine in the left arm. She stated that she thought the documentation from the ER report was incorrect and should have read in the right arm. On 10/26/02, the pt returned to the ER for follow-up. On physical examination, the cellulitis had receded from the outer margins of the previous day's visit. The pt stated that she was feeling somewhat better; however, she did continue to have mild pain in the left arm. The pt had no fever. The pt had an IV established and was given ceftriaxone 2mg IV. The pt was started on therapy with Duricef and was sent home. The nurse indicated that she followed up with the pt, and she had subsequently recovered. Upon internal review, the pt's cellulitis was considered an other medical event (OMIC). The nurse also reported that a pt developed injection site swelling, inflammation, erythema, pain and drug hypersensitivity (WAES0210USA02661) and another pt developed injection site erythema and inflammation (WAES0210USA02662) post-vaccination with pneumococcal vaccine 23 polyvalent. No additional info is expected.				Y					Y	10/23/2002	10/23/2002	0	UNK	PVT	PVT			Diabetes Mellitus; Drug hypersensitivity		WAES0210USA02344	1						1	Cellulitis; Headache; Hypokinesia; Injection site erythema; Injection site oedema; Injection site pain; Injection site reaction; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0111M~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0194404	12/02/2002	MS	13.0	13		F	12/02/2002	Pts mother, called reporting on 11/18/02 that patient was very weak and had temp of 102.5 over the weekend of the 15th through 17th.  On 11/19/02 Dr. called to report patient was ok.									Y	11/13/2002	11/15/2002	2	Not applicable.	PVT	PUB	Conarta 54 mg	none	asthma/Bronchitis fall season		MS02038	1						1	Asthenia; Pyrexia; Asthenia; Pyrexia	FLU3~SANOFI PASTEUR~40971AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0735m~2~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U0971AA~6~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0735M~2~IM~RL~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0194506	12/02/2002	OK	17.0	17		M	12/02/2002	Given Td/Influenza (same syringe)on 11/6, already had flu like symptoms at time of vacination. 11/9 showed increased signs of flu like symptoms, pain in neck and chest. 11/10 began vomiting, complained of chest pain rapid heart beat, had fever. 11/11 was given antibiotics at job corp center and sent home w/complaints of chest pain and coughing up green and black stuff. Continued to vomit thru 11/12, had appointment to go to private doctor on 11/13. 11/13 0500 am collapsed. Taken to emergency room. BP low and continued to decrease. Showed enlarged heart and liver, kidneys shutting down. Dignosed with myocarditus, inflamation of heart muscle. Placed on ventilator for three days. Survived illness at this point heart functioning at 30%. Continued treatment indefinite at this point in time.			Y	Y	Y	10		Y	N	11/06/2002	11/09/2002	3	heart biopsy 11/15. various blood and labs done throughout hospital stay.	PUB	UNK	none	Flu Like, nausea, sinus, diahrea, coughing up flem.	n/a			1						1	Blood pressure decreased; Cardiomegaly; Cough; Heart rate increased; Hepatomegaly; Influenza like illness; Myocarditis; Pain; Pyrexia; Renal failure; Syncope; Vomiting	FLUX~UNKNOWN MANUFACTURER~F31202GA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~SANOFI PASTEUR~n/a~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0193185	12/03/2002	ND	31.0	31		F	10/31/2002	Patient developed painful lump at the site of injection, which persists 4 weeks later.				Y					Y	10/01/2002	10/02/2002	1		MIL	MIL		NONE	NONE			1						2	Injection site mass; Pain; Injection site mass	FLU3~SANOFI PASTEUR~U0880AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0880AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0194408	12/03/2002	PA	56.0	56		F	11/19/2002	Red, inflamed, size of silver dollar, with swelling size of small apple; area tender, warm with upset stomach				Y					Y	11/12/2002	11/13/2002	1		PUB	PUB	BP medicine, Reemerin	NONE	Benadryl - Darvon			1						1	Dyspepsia; Oedema; Vasodilation procedure	FLU3~SANOFI PASTEUR~U0958AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0194409	12/03/2002	WY	1.5	1	.5	F	11/27/2002	Broke out in rash starting 11-19-02. Seen PAC on 11-22-02 with diffuse rash covering face, neck, abdomen and shoulders. Spotty on legs. Rx: Tapering dose Redi-Pred. 11-27-02 almost gone.									U	11/18/2002	11/19/2002	1		PUB	UNK						1						1	Rash	FLU3~PFIZER\WYETH~4020037~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0194414	12/03/2002	MO	45.0	44		M	11/19/2002	10 days after receiving a flu shot, the pt developed severe muscle pains in the legs and shoulders, followed by bilateral leg weakness and inability to stand unassisted. He demonstrated areflexic quadriparesis, dysarthria, and bifacial weakness, resting tachycardia, hypertension and intermittent diaphoresis. The pain required neurontin.					Y	30			Y	10/16/2002	10/24/2002	8	Spinal fluid protein 168, glucose, WBC normal. NCS/EMG showed 3 of 4 motor nerves with conduction block and evidence of demyelination of MRspine normal. CPK normal.	PUB	UNK		Schizophrenia	Previous Guillain -Barre 1989 after flu shot	Guillain Barre~Influenza (Seasonal) (no brand name)~~3.00~In Patient		1						1	Demyelination; Dysarthria; Guillain-Barre syndrome; Hyperhidrosis; Hypertension; Laboratory test abnormal; Muscular weakness; Myalgia; Pain; Paresis; Tachycardia; Vaccine positive rechallenge	FLU3~EVANS VACCINES~E35462HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0194415	12/03/2002	OR	72.0	71		F	11/24/2002	24 hrs after administration-pt's arm became erythematous, swollen, painful.					Y	2			Y	11/06/2002	11/08/2002	2	WBC 14,000, 80% sezs 2% bond	OTH	PVT	Synthroid, Vasotec, Sosamax	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~EVANS VACCINES~E34682HA~5~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~541M~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0194416	12/03/2002	NJ	56.0			F	11/28/2002	Seen 11/14/02 with 2 week history of numbness of left leg and right, arms left and right. Spreading recently to right side of face. Started 1 week after flu vaccine. 12/13/2002 pt here for routine check-up and follow up. s/p					Y	3			Y		11/01/2002		Negative MRI of Brain; Spinal Cord negative	PVT	UNK		NONE	None			1						1	Hypoaesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0194423	12/03/2002	CA	41.0	41		F	11/29/2002	Developed rash on stomach, back, legs, butt, arms that was raised bumps.									Y	11/18/2002	11/19/2002	1		UNK	UNK		NONE	Allergic to composite and aristocort			1						1	Rash maculo-papular	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0194425	12/03/2002	MS	65.0	65		F	11/20/2002	Phone call from patient stated afternoon 11-19-02 very achy muscle bone, weak, slight nausea, quarter size local reaction right deltoid. Sore to touch, red. Referred patient to PMD. Stated she would go if no improvement or worsens; patient went to PMD in p.m., given shot and cephalexin 500mg potid to take home. 11-21-02 patient states feel fine today.				Y					Y	11/19/2002	11/19/2002	0	UNK	PUB	PUB	Prinzide 20-2mg poqd, Premarin 3-4 days a week	UNK	Codiene		MS02037	1						1	Nausea; Pain	FLU3~PFIZER\WYETH~4020030~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0445M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0194426	12/03/2002	CT	38.0	38		F		Deltoid sore for 6 weeks. Pain with movement. No swelling, redness or warmth.				Y					N	10/16/2002	10/16/2002	0	MRI Left shoulder - pending.	PVT	UNK	Detrol, Metrofurantoin	left ear pain & sinusitis				1						1	Hypokinesia; Myalgia; Pain	FLU3~SANOFI PASTEUR~U0927AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0194427	12/03/2002	OH	72.0	72		M	10/28/2002	Arm that received pneumonia shot became red, swollen, painful and warm to touch the evening after the shot was given. The area of inflammation extended from deltoid to wrist. This lasted 3-4 days then resided. nurse recommended cold compress, elevation, Advil.									Y	10/08/2002	10/08/2002	0		PUB	PUB		NONE	NONE		OH0045	1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~60913AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0445M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194428	12/03/2002	OH	57.0	57		F	11/06/2002	Client received flu shot and then developed a localized rash and warmness at injection site. She took Benadryl and put Lotrisone Cream on it. If symptoms don't subside, she will go to ER. Redness and rash cleared the following day.									Y	11/05/2002	11/05/2002	0	NONE	OTH	PVT	Dyazide, Welchol	NONE	HTN, High Cholesterol		OH0044	1						1	Feeling hot; Injection site erythema; Injection site rash	FLU3~EVANS VACCINES~E3202072GA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0194429	12/03/2002	OH	75.0	75		M	10/25/2002	Pt developed redness, swelling of right arm from deltoid muscle down to wrist involving all but inner aspect of upper arm. Fluid accumulation around elbow and discomfort on moving started evening after shot lasted 3-4 days. Advised elevation, ice, Advil.									Y	10/01/2002	10/01/2002	0		PUB	PUB		NONE	NONE		OH0047	1						1	Discomfort; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U0913AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0445M~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194430	12/03/2002	CA	8.0	8		F	11/22/2002	Swelling, redness, and induration on right arm at site of injection.									Y	11/19/2002	11/21/2002	2		PVT	PUB	NONE	URI and Pharyngetis	Allergic to PCN			1						1	Injection site erythema; Injection site induration; Injection site oedema	FLU3~SANOFI PASTEUR~E331526A~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194431	12/03/2002	MN	44.0	44		F	11/20/2002	11/14/2002 Flu shot given. 11/18/2002 Jr stooped at CPHS Toreport that 11/15 at 10:30 while laying in bed felt dizzy for a few seconds and then passed, reported drank glass of colna but that didn't make the dizzy before. On 11/17 reports she got up at 6:30 and fell back in bed with c/o feeling dizzy, stated she did get up fast 11/18 at 01:00 am states to have gotten up at HS and again felt dizzy, no dizziness in am but reports to have gotten up slowly. No c/o dizziness now or at other times on the weekend. Discussing c/o dizziness from others in the community that had not gotten flu shot, questioned others S+S. c/o hand hurting when riping out some parts also c/o a thickness in voice when talking but no one else noticed this. 11/20/02 TC to JR no home or work. 11/20/2002 TC to manufact reported above, TC message left with manufact to return call. 11/21/2002 TC to JR no c/o dizziness now. Reports by 11/18 felt better after work. Reports hands felt like she had too much salt over weekend had taken  ASA qd on Sat- Sun no relief. Did not expand on thickness in speech except felt funny in hand. Again denied any S+S of thick tongue, swollen lips. Encouraged her to call her MD and report everything. She had to me and discuss recommendations for getting that flu shot in the future.									Y	11/14/2002	11/15/2002	1	NONE	PUB	PVT	Ativan 0.5 mg last dose 11/19/2002, Synthroid 150 mcg  qd	NONE	Hypothydrodism			1						1	Dizziness; Dysphonia; Pain	FLU3~PFIZER\WYETH~4020022~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0194432	12/03/2002	NV	52.0	52		F	11/20/2002	Fever, chills, dizziness, difficulty breathing, swelling at site of injection, fast heartbeat, muscle aches									Y	11/09/2002	11/09/2002	0		PUB	OTH		NONE	Post polio, Degenerative Bone Disease			1						1	Chills; Dizziness; Dyspnoea; Heart rate increased; Injection site oedema; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0194433	12/03/2002	WA	60.0	60		F	11/25/2002	Flu shot received on 10/29/2002- painful initially and pain in left upper arm persisting. Sharp pain present especially with reaching or extension of left arm.									N	10/29/2002	10/29/2002	0	NONE	OTH	OTH	Hormone Replacement Therapy	NONE	Codine			1						1	Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U0906AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194434	12/03/2002	NY	37.0	37		F	11/25/2002	Migraine headache, fever for 3 hours. Took Advil. Diarrhea for 12 hours. Took Immodium									Y	11/14/2002	11/14/2002	0		PVT	OTH	Celexa40mg	NONE	NONE			1						1	Diarrhoea; Migraine; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0194435	12/03/2002	CO	79.0	79		F	11/14/2002	Trouble breathing while sleeping, dry throat, red itchy eyes, very tired, cough and runny nose									Y	10/31/2002	11/05/2002	5		PUB	OTH						1						1	Cough; Dry throat; Dyspnoea; Fatigue; Ocular hyperaemia; Rhinorrhoea	FLU3~SANOFI PASTEUR~U0688AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194436	12/03/2002	AL	64.0	64		F	11/25/2002	Flu shot received on 10/21/2002. Initial medical exam on 11/04/2002: blood test initiated: no diagnosis made at time. Examined by neuroligist on 11/12/2002: diagnosed was Guillain-Barre Syndrome: more blood test. Continues normal activities when possible with assistance. Loss of reflexes. Test results unknown at this time									Y	10/21/2002	10/26/2002	5	Electrical test of nerve and muscle function/ hands and feet. Spinal tap. Additional blood test	OTH	UNK	NONE	NONE	NONE			1						1	Guillain-Barre syndrome; Hyporeflexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0194437	12/03/2002	GA	61.0	61		M	11/25/2002	Transient global amnesia. Occurred four days after shot. Lasted approximately 8 hours, recovered completely.				Y					Y	11/16/2001	11/21/2001	5	CT scan (negative)	OTH	PVT	NONE	NONE	NONE			1						1	Amnesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0194438	12/03/2002	PA	48.0	48		M	11/08/2002	Pt received influenza vaccine and PPV-23 vaccine on 11/4/02. Requested vaccine be given in Lt arm. Wife stated pt developed fever 105 degrees and swollen lymph glands Lt axilla, headache, chills later that evening.				Y	Y	2			Y	11/04/2002	11/04/2002	0	Blood cultures-negative; WBC increase 31,000	PUB	UNK	Prevacid, Claratin, Anapril, Lipitor, Nesipan, ASA, Ind, Metalapralol	None	Environmental allergies		PA0243	1						1	Chills; Headache; Lymphadenopathy; Pyrexia; White blood cell count increased	FLU3~SANOFI PASTEUR~U09377AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0445M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0194439	12/03/2002	PA	29.0	29		F	11/06/2002	Received influenza vaccine at approximately 3pm on 11/5/02. At around 5:30pm, began experiencing weakness of the right arm and tingling in the fingers of the right hand. This continued through the evening and today 11/6/02 - with swelling of the right arm, numbness and tingling in right arm. Took Ibuprofen 11/5 morning and 11/6 morning. Referred to physician.				Y					N	11/05/2002	11/05/2002	0		PUB	OTH	NONE	NONE	NONE		PA0242	1						1	Hypoaesthesia; Myasthenic syndrome; Oedema; Paraesthesia	FLU3~SANOFI PASTEUR~U9037AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0194440	12/03/2002	WI	60.0	60		F	11/25/2002	Pain in right arm after 4 days. Pain in both arms above elbow and in shoulders - some muscular discomfort in right leg - pain intense at times.				Y					N	10/23/2002	10/23/2002	0	Blood tests done 11/15/2002; Elevated white count; Elevated SEO rate	PUB	OTH	NONE	NONE	Penicillin allergy			1						1	Myalgia; Pain	FLU3~PFIZER\WYETH~4020022~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0194441	12/03/2002	MA	66.0	66		F	11/23/2002	Six hours after injection developed severe chills, muscle pain, nausea and headache. Lasted through the night.									Y	11/05/2002	11/05/2002	0		UNK	UNK		NONE				1						1	Chills; Headache; Nausea; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0194442	12/03/2002	VA	73.0	73		F	11/23/2002	Very severe pain, aching, throbbing, stabbing, burning on whole upper arm shoulder area. It is still very intense and is almost 4 weeks now. Doctor recommended heat and Tylenol. Didn't help. Stronger pain killers do not help. Doctor gave Bextra samples to try.				Y					U	10/28/2002	10/28/2002	0		OTH	UNK	Synthroid, Imdur, Pepcid, Dilitzem HSL, Amitriptyline, Estaderm, Aspirin		Fibromyalgia, Heart disease			1						1	Myalgia; Pain	FLU3~EVANS VACCINES~E3572HA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0165M~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0194443	12/03/2002	CA	75.0	69		F	11/22/2002	Local erythema, induration at site. Right upper extremity SQ. Malaise, sub, fever and headache.									Y	11/21/2002	11/22/2002	1		PUB	PUB		HTN, OA	NONE			1						1	Erythema; Headache; Injection site induration; Malaise; Pyrexia	FLU3~SANOFI PASTEUR~U0971AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0172M~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194444	12/03/2002	CA	68.0	68		F	11/26/2002	Pneumonia shot early morning (along with flu shot). 10-28-02 by afternoon could not lift right arm. Continued to swell, by Wednesday twice normal size. Hot and achy. Friday swelling began to decrease. Last pneumonia shot 11/95 no problems.									Y	10/28/2002	10/28/2002	0		OTH	OTH	NONE	NONE	NONE			1						1	Hypokinesia; Myalgia; Oedema; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0194445	12/03/2002	CA	45.0	45		F	12/03/2002	Noticed redness/soreness/ had hard lump(very slight) at injection site next afternoon of injected flu vaccine (11/18/02). Used cold packs every couple of hours for next day during waking time period (8:30am-11pm) Swelling gone next day 11/20/02 and redness completely gone by 11/22/02 but still complains of mild pain, but getting progressively better. Temperature was 96.7 and steady at this rate for 24-36 hours.										11/18/2002	11/19/2002	1		OTH	OTH			Born with Cerebral Palsy but mentally challenged not physically; hepatitis B carrier			1						1	Injection site mass; Oedema; Pain; Vasodilation procedure	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0194446	12/03/2002	WI	5.0	5		F	11/16/2002	November 2000 first shot, December 2000 second shot within a couple of days after second shot patient broke out with pitariasis itching. She saw doctor for this who then referred her to dermatology. After almost a year of fight with the rash she was about clear. She again had the flu shot October 2001 again within a couple of days was coated with the rash from head to toe. Went almost another year all clear again. On October 22/23, 2002 had a flu shot and in 2 days has broke out again from head to toe with pitariasis.									N	10/23/2002	10/25/2002	2		PVT	OTH	Singulair 4mg 1x Dq; Zyrtec 10mg 1xDq	NONE	Asthma, allergic to grass, trees, dust, ragweed, erithramiacin	itchy rash~Influenza (Seasonal) (no brand name)~2~3.00~In Patient		1						1	Rash pruritic	FLU3~SANOFI PASTEUR~U0888AA~4~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194447	12/03/2002	TN	1.5	1	.5	M	11/20/2002	Marked edema and erythema of left thigh with well demarketed edges. Normal modes, normal CBC. No pain or tenderness. Rx'd with Atarax. As per acknowledgemnet letter, an correction needed in MDs				Y					Y	11/18/2002	11/20/2002	2	WBC=11.0, 49L, 7M, 435, HgB=11/1, Pit=384	PVT	PVT	NONE	NONE	NONE			1						1	Erythema; Oedema	DTAP~SANOFI PASTEUR~U0583CB~4~~LL~DTAP (TRIPEDIA)~1|FLU3~PFIZER\WYETH~40200076~1~~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|MMR~MERCK & CO. INC.~0629M~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0194448	12/03/2002	NC	51.0	51		F	11/25/2002	Swelling of extremities and joints; numbness in fingers and toes. Symptoms began 11/6/02 when patient went to ER. Dx: Lyme disease, allergic reaction, arthritis or Lupis.									U	10/12/2002	11/06/2002	25		OTH	PVT	Tyzack, Nadalow, Nexium, Cynthroid, Astrodyal, Clarinex	NONE	High blood pressure, Underactive Hypothyroid, Acid Reflux			1						1	Oedema peripheral; Paraesthesia	FLU3~SANOFI PASTEUR~U0872AB~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194449	12/03/2002	VA	32.0	32		M	11/26/2002	Started itching Friday night - Itches off and on. If doesn't scratch, won't pop up. Started taking Benadryl 11/23/02. Continuing - States has hives - Denies any allergies to eggs or other components.									Y	11/21/2002	11/22/2002	1		PUB	PUB	Claritin q day					1						1	Pruritus; Urticaria	FLU3~PFIZER\WYETH~4020029~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0194450	12/03/2002	OR	51.0	51		F		Vaccine administered up/mid left arm. Muscle fatigue resulted approximately 2.5-3 hours after. Inability to move arm between shoulder and elbow. Able to move elbow, hand and fingers. Second day able to move arm only if palm of hand turned skyward. Aching, deep pain in forearm and tingly fingers. Lasting more than 3 weeks.				Y					U	11/01/2002	11/01/2002	0		PVT	OTH	Zyrtec, Estrogen	NONE				1						1	Hypokinesia; Myasthenic syndrome; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U0953AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0194507	12/03/2002	NY	47.0	47		M	12/03/2002	Flu shot given 29Oct02 in right arm, was hurting for a couple of days and then wasn't noticed for a couple more days and then the pain returned. The pain has lasted until this date. Also as of last night a bruise on the forearm about 8inches long and 3inches in width appeared.				Y					U	10/29/2002	11/05/2002	7		UNK	MIL	Reflux meds (rab?) (pt did not know the complete name)	cold without the presence of a fever	None			1						1	Contusion; Pain	FLU3~SANOFI PASTEUR~U0905FA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0194508	12/03/2002	MS	10.0	10		M	12/03/2002	on 11/08/02, patients mother, called reporting  patient had rash and big red knot. no fever reported.  Stated appeared over the weekend of 11/15/02.  On 11/19/02 Dr.reported  patient was doing fine									Y	11/13/2002	11/15/2002	2	None	PVT	PUB	Cencerta 3e	None	Recurrent bronchitis ( drug allergies)		MS02039	1						1	Erythema; Injection site mass; Rash	FLU3~SANOFI PASTEUR~U0971AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0735M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194563	12/03/2002	NY	45.0	45		F	12/03/2002	hoarseness, cough, mild fever, chills, phlegm				Y					Y	10/24/2002	10/25/2002	1		PVT	UNK		none	hay fever, ragweed			1						1	Chills; Cough; Dysphonia; Pyrexia	FLU3~PFIZER\WYETH~basic flu shot~UNK~SC~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0194565	12/03/2002	NY	40.0	40		M	12/03/2002	2nd day right arm where shot given, paralyzed partially betweeen elbow and shoulder, bright red, low grade fever-101f. Told by nurse this is normal. 3rd day fever of 102.5 arm now black and blue and red with pickly heat or scaretina signs. Went to Dr. Given keflex antibiotic, and told to take ibuprofen as needed to treat fever. Patient not fully recovered until following Monday 12/24. Update 12/03/02 Arm still slightly weak, and itchy once in a while at site of injection. Continuing prescribed antibiotics. Fever gone.				Y					U	11/18/2002	11/19/2002	1		PVT	PVT	Avodart 0.5mg, Xanax 0.5mg as needed, Zoloft 100mg 1X per day, Nexium.	None	Seasonal allergies, mold, dust. Kidney Stones, Enarged prostate, Diverticulum.			1						1	Asthenia; Contusion; Erythema; Paralysis; Pruritus; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0194518	12/04/2002	KS	13.0	13		M	12/03/2002	Muscle aches < 24 hrs post vaccine. Difficulty with strength and balance (pulling self up the stairs) day 3 or 4 post vaccine. Seen by MD 11/1/02. Did have muscle soreness in area and neck the night of the vaccine. Still balance/muscle sx. EMG-finding consisted with Guillain Barre-strahl synd. Rec'd IVIG tx. x 5 days. Follow-up information received on 3/4/2003 states that large motor coordination not back to baseline.  Pt's energy level is improving but he still tires at school, especially by the end of the week.  Patient continues to make slow progress eventhough he is not back to his baseline.  Annual follow up on 12/24/03: Vaccine recipient has recovered from adverse events that was reported for this vaccination.					Y	4			N	10/29/2002	10/30/2002	1	EMG findings consistent with Guillain Barre Strahl Syndrome. Received IVIG tx for 5 days.	PVT	PVT	Albuterol, Creon, MV, Vitamin E, Pulmozyine, Zantac	None	Cystic Fibrosis			1						1	Asthenia; Balance disorder; Guillain-Barre syndrome; Myalgia	FLU3~SANOFI PASTEUR~U0911BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0194519	12/04/2002		63.0			M		A report was received from a regulatory authority on 11/25/02, concerning a 63 year old male vaccinee who experienced a frozen shoulder which was considered to be disabling or incapacitating and required hospitalization 2 days after receiving the Fluvirin vaccine on 10/04/02. The vaccinee was receiving lisinopril concomitantly. On 10/6/02 the vaccinee experienced a frozen shoulder which lasted for 5 days and required hospitalization. The vaccinee recovered on 10/14/02. There was insufficient information to determine the reporters causality assessment.					Y			Y		10/04/2002	10/06/2002	2		UNK	UNK	Lisinopril				PJP200200813	1						1	Joint stiffness	FLU3~EVANS VACCINES~763604~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0194520	12/04/2002		54.0			M		A report was received from a regulatory authority on 11/25/02 concerning a 54 year old male vaccinee who experienced a cold (3 days post vaccination), muscle pains (7-10 days post vaccination), decreased urinary output (9 days post vaccination), diagnosed as rhabdomyolysis with acute renal failure after receiving the Fluvirin vaccine on 10/18/02 which involved or prolonged hospitalization, involved persistent or significant disability or incapacity and was medically significant. The vaccine had a history of deep vein thrombosis, inferior vena cava obstruction, hypertension, renal allograft and end stage renal failure. The vaccinee was receiving ciclosporin, prednisolone, sirolimus, atenolol, doxazcsin, simvastatin, omeprazole and warfarin concomitantly. On 10/21/02, the vaccinee experience cold symptoms. Seven to 10 days later the vaccinee had muscle pains and on 10/27/02, decreased urinary output. A renal biopsy was performed and nothing abnormal was detected, that is, no rejection of the allograph. A diagnosis of rhabdomyolysis with acute renal failure in the transplant kidney was made which required dialysis treatment. The vaccinee had not recovered. There was insufficient information to determine the reporters causality assessment.					Y		Y	Y		10/18/2002			Renal Biopsy - nothing abnormal detected, is not rejected	UNK	UNK	Cyclosporin, Prednisolone, Sirolimus, Atenolol, Doxazosin, Simvastatin, Omeprazole, Warfarin		Vein thrombosis deep, Inferior vena caval obstruction, hypertension, renal allograft, end stage renal failure secondary membranous glomerulonephritis		PJP200200812	1						1	Anuria; Myalgia; Pharyngitis; Rhabdomyolysis; Rhinitis	FLU3~EVANS VACCINES~763674~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0194528	12/04/2002	KY	32.0	32		F	11/21/2002	Rapid heart beat, dizziness, headache, vomited. Transported to ER.				Y					Y	11/18/2002	11/18/2002	0		PUB	PUB		NONE	Multiple general allergies		KY2002049	1						1	Dizziness; Headache; Heart rate increased; Vomiting	FLU3~SANOFI PASTEUR~U0882AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0194530	12/04/2002	WI	1.4	1	.4	M	11/25/2002	6cmx8cm area of non-tender redness and swelling left thigh.				Y					Y	11/20/2002	11/21/2002	1		PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U0939AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~485985~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0194531	12/04/2002	OH	75.0	75		F	11/24/2002	Upper arm became painful shortly after receiving vaccine. By evening arm was swollen from elbow on up. Next morning it was not only quite painful, it hurt to move it, wa swollen and red. The doctor prescribed Lorabit/prednisone and return visit the next day.				Y					Y	10/30/2002	10/30/2002	0		PUB	UNK	Lactulose; Eye drops		Allergic to amoxicillin			1						1	Erythema; Joint range of motion decreased; Pain; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0194532	12/04/2002	MO	76.0	76		F		Severe chills, fever for 24 hours after shot. Saw doctor 11/14/02; antibiotics given.				Y					Y	11/13/2002	11/13/2002	0	NONE	PUB	PVT		NONE				1						1	Chills; Pyrexia	FLU3~SANOFI PASTEUR~U0946AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0194533	12/04/2002	AR	74.0	74		F	11/22/2002	Received flu vaccine 10/30/02 at 12PM. Went home feeling ill with chills by 14:00. At 16:00, developed hives, posterior and anterior chest, axilla, and bilateral legs. Experienced generalized burning and stinging in area of rash.									Y	10/30/2002	10/30/2002	0		UNK	UNK	NONE	NONE	Previous asthma			1						1	Chills; Malaise; Rash; Thermal burn; Urticaria	FLU3~EVANS VACCINES~E33902HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0194534	12/04/2002	UT	41.0	41		F	11/22/2002	Patient received shot in right deltoid at 08:00 on 11/17/02. Reaction began at 15:00 same date: swelling, red welts, difficulty moving arm from soreness, body aches. Patient stated all better by 11/21/02, except small amount of body aches.									Y	11/19/2002	11/19/2002	0		PVT	PVT	NONE	NONE	NONE			1						1	Erythema; Injection site swelling; Joint range of motion decreased; Pain; Urticaria	FLU3~SANOFI PASTEUR~U0875AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0820M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194535	12/04/2002	UT	37.0	37		F	11/22/2002	Patient received vaccination 1/20/02 at 12:00. By 17:00, patient had fever, chills, right arm was frozen to shoulder, welts, rash and difficulty sleeping. By 11/21/02, patient still achy, but better. Took some Benadryl. By 11/22/02 swelling and aching gone; still some welts present.									Y	11/20/2002	11/20/2002	0		PVT	PVT	NONE	NONE				1						1	Chills; Insomnia; Musculoskeletal stiffness; Pain; Pyrexia; Rash; Urticaria	FLU3~SANOFI PASTEUR~U0875AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0820M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194536	12/04/2002	MN	57.0	57		F	11/25/2002	Excess fluid hands, legs, feet, when received vaccine. Had instant sting and burn in spine; center of shoulders and then all over for a couple of seconds. Seems to be going away.										11/21/2002	11/22/2002	1		PUB	PUB						1						1	Fluid retention; Pain; Thermal burn	FLU3~PFIZER\WYETH~4020027~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0194537	12/04/2002	UT	59.0			F	11/27/2002	Developed area of redness, warm to touch, elevated area approximately 3 inch diameter. Referred to PCP for treatment.														UNK	UNK			Childhood allergy to eggs			1						1	Feeling hot; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U0953AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194538	12/04/2002	CA	74.0			F	11/26/2002	Patient was administered a flu and pneumonia vaccination on Wednesday 11/20/02. Patient phoned HCP on 11/22/02 and stated she had fever, redness, and swelling at injection site and felt pain in glands under left arm and left side of neck. LVN at HCP referred patient to MD immediately.				Y					U	11/20/2002	11/22/2002	2		OTH	OTH	UNK	UNK	UNK			1						1	Injection site erythema; Injection site swelling; Neck pain; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U0883AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0872M~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0194539	12/04/2002	CA				F	11/22/2002	Redness, pain at injection right deltoid. Raised rash from neck to middle of back. Referred to MD immediately.				Y					U	11/07/2002	11/11/2002	4	UNK	OTH	OTH	UNK	UNK	UNK			1						1	Injection site pain; Injection site swelling; Rash erythematous	FLU3~SANOFI PASTEUR~U0883AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0111M~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0194540	12/04/2002	MI	55.0	55		F	11/26/2002	Received flu and pneumovax on 11/18/02. At approximately 11PM on 11/18/02, began to feel achy, back hurt, sweating, ribs hurt, swelling in abdomen. ER on 11/19/02. Advised rest, Tylenol. CXR and labs done.				Y					N	11/18/2002	11/18/2002	0	CXR and CBC done on 11/19/02 in ER	PVT	PVT		NONE	PCN			1						1	Abdominal distension; Back pain; Chest pain; Hyperhidrosis; Pain	FLU3~SANOFI PASTEUR~U0950AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|RUB~MERCK & CO. INC.~0872M~1~IM~RA~RUBELLA (MERUVAX II)~1	USA	Emergency room visit	Influenza
0194561	12/04/2002	NJ	29.0			F		A report received on 10/9/02 from a consumer, concerning a 29 year old female vaccinee who experienced severe pain and swelling in the big toe after receiving a Fluvirin vaccine on 10/1/02. On 10/3/02 the pt experienced severe pain and swelling in the big toe after receiving one dose of Fluvirin vaccine IM on 10/1/02. The pt was seen by a physician in an emergency room. The physician took blood samples and suspected gout. The following day the pt was seen by her primary physician who also suspected gout. On 10/5/02 the pt was seen by a rheumatologist and states that the preliminary diagnosis appears to be gout, even though the pt's age, medical history and life style were not typically associated with gout. The rheumatologist checked the uric acid levels, which were not elevated. The physician prescribed oral anti-inflammatory medication and injected an unknown drug into the affected joint at the time of the appointment. The physician has not diganosed the pt with gout. It was unknown if the pt received flu vaccines in the past. At the time of reporting the pt had recovered. On 11/1/02 a follow up report was received. It was reported that the onset of symptoms began on 10/2/02. On 10/3/02 the vaccinee went to her doctor who suspected gout and took blood for uric acid levels. A foot x-ray was performed and was negative. The affected joint was injected on 10/5/02 and the pt experienced relief by the 10/6/02. The pt was concomitantly receiving the oral contraceptive pill orally. On 11/22/02 a follow up report was received confirming that the Fluvirin batch number was this manufacturer's batch number.				Y					Y	10/01/2002	10/02/2002	1	uric acid levels normal; x-ray normal	UNK	UNK	Oral contraceptive pill				PJP200200481	1						1	Pain	FLU3~EVANS VACCINES~E30442GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0194569	12/04/2002	CT	0.0	62		F	12/04/2002	10/28/02  Recieved a flu vaccine at between 11:00am-1:00 at a flu clinic in L deltoid, that evening at 8:00pm taken to an ER for throat swelling hives and overall reaction to something, treated and watched till 3am.  11/14/02 saw an allergist				Y					Y	10/28/2002	10/28/2002	0		UNK	PVT	Verapamil, nexium, Prempro, Viox	No				1						1	Pharyngeal oedema; Urticaria	FLU3~EVANS VACCINES~E31172GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0194604	12/04/2002	WI	43.0	43		F	12/04/2002	Hives appeared on upper chest and breast area, and on lower middle back approximately 27 hours after receiving both the influenza and pneumonia vaccines.									Y	10/11/2002	10/12/2002	1		PVT	PVT	Patient has been diagnosed with MS and is currently taking Copaxone, Estraderm, Clarinex, and Flonase	None	Multiple Sclerosis Sinusitis Complete Clinical Hysterectomy			1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~unknown~1~SC~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~unknown~1~SC~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0194605	12/04/2002	DE	39.0	39		F	12/04/2002	On the day following the administration of the Influenza Vaccine on the left arm, I again noticed significant swelling in the left axilla, coming down to the top of my left breast. Touching of the swollen glands in the area was indicative of swelling in the lymph nodes of the area. Additionally, at the site of the injection there was an elevated, red swelling of approximately 2.5 inches in diameter. This is the second time I have had the influenza vaccine administered. The first time was last year, 2001, in which I had more severe swelling of the inside upper arm, axilla, and full swelling of the left breast.									Y	11/18/2002	11/19/2002	1		UNK	PVT	None	None	Fibromyalgia (Diagnosed 2000)	Same as above but more severe with significant inflamation of the left breast and axilla.~Influenza (Seasonal) (no brand name)~1		1						1	Injection site erythema; Injection site oedema; Lymphadenopathy	FLU3~PFIZER\WYETH~U0910AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0194606	12/04/2002	MS	64.0	64		F	12/04/2002	Patient called 11/22/02 stated she received flu shot on the morning of 11/18/02 in right arm.  By that evening she had extreme pain in right hip pain was better on 11/22.									Y	11/18/2002	11/18/2002	0	None	PUB	PUB	none	not applicable	not applicable		ms 02 040	1						1	Pelvic pain	FLU3~SANOFI PASTEUR~U0971AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194574	12/05/2002	CA	65.0			F	11/19/2002	The discharge summary states decubiti.			Y						Y	11/05/2002	11/13/2002	8		UNK	UNK			GERD, depression, degenerative disc disease			1						1	Guillain-Barre syndrome; Hypoaesthesia; Hypokinesia; Muscular weakness; Pain; Paraesthesia; Rhinorrhoea; Skin ulcer; Sneezing	FLU3~EVANS VACCINES~34662HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening	Influenza
0194575	12/05/2002	NM	49.0	48		F	11/26/2002	Cerebellar encephalitis, cerebellar syndrome incoordination. Patient experienced 4/10 pain in the hands, arms, feet, back and hips. Patient also had an unsteady/disturbed gait and blurred vision/double vision-horizontal nystagmus; she also experienced dizziness, malaise, achiness, and a fever up to 100F. The patient also had episodes of incontinence. The discharge summary states encephalopathy and urinary tract infection					Y	5			Y	11/02/2002	11/09/2002	7	Lumbar puncture - CSF cell count WBC 13/mm3, 96 mononuclear; MRI - negative, unremarkable, HSV by PCR - not detected. Lumbar Puncture, MRI, HSV by PCR	PVT	OTH		NONE	NONE			1						1	Back pain; Balance disorder; Cerebellar syndrome; Coordination abnormal; Diplopia; Dizziness; Encephalitis; Encephalopathy; Gait disturbance; Malaise; Nystagmus; Pain; Pain in extremity; Pyrexia; Urinary tract infection; Vision blurred	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0194576	12/05/2002	NJ	40.0	50		F	12/04/2002	Left arm sore immediately; difficulty moving/raising left armfrozen shoulder 2-3hours. Later patient reported this 11/22/02. Given Naprosyn 500mg BID for 3 days. Reports almost complete improvement									Y	10/31/2002	10/31/2002	0	NONE	PVT	UNK	Multivitamin, Calcium E	NONE	NONE			1						1	Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U0926CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194577	12/05/2002	AR	3.0	3		M	12/04/2002	Erythema Rash macropapular with swelling, induration, high local temp. Right thigh (site of flu shot IM .5ml)									Y	12/02/2002	12/03/2002	1	NONE	PVT	PVT		URI	Amoxil, Antibidric, EM, OM, RAD			1						1	Erythema; Rash maculo-papular	FLU3~PFIZER\WYETH~4020036~1~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0194578	12/05/2002	TX	56.0	56		F	12/03/2002	Approximate ten minutes after receiving injection, complained of wave-like feeling inside body and need to clear throat. Later (several days) cold chills, prespiring, feeling of water in lungs with difficulty breathing off and on.									Y	11/13/2002	11/13/2002	0	NONE	OTH	OTH		NONE	UNK			1						1	Dyspnoea; Feeling cold; Hyperhidrosis	FLU3~SANOFI PASTEUR~U0958AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194579	12/05/2002	TX	52.0	52		M	12/03/2002	Sore arm dull ache for four days after injection. Chills off and on, body aches and gets hot intermittently, flu-like symptoms, little energy. 11/28 and 11/29 sweated heavy, stomach cramps. 11/29 and 12/1  unable to eat.  12/3 feeling better.									Y	11/04/2002	11/04/2002	0		OTH	OTH	Glucovance	NONE	Heart attack January 1998			1						1	Chills; Decreased appetite; Hyperhidrosis; Influenza; Myalgia; Pain	FLU3~SANOFI PASTEUR~U0913AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194600	12/05/2002	CA	5.0	5		M	12/04/2002	Redness over immunization site with swelling around 10cm in diameter negative systemic symptoms.									Y	12/02/2002	12/04/2002	2	NONE	PVT	PVT		NONE	NONE			1						1	Injection site hypersensitivity; Injection site oedema	FLU3~PFIZER\WYETH~4020014~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0194602	12/05/2002	CA	19.0	19		M	12/04/2002	70mm red area, tenderness in that area and fever.									N	12/02/2002	12/03/2002	1		UNK	UNK						1						1	Pain; Vasodilation procedure	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0194603	12/05/2002	GA	1.4	1	.4	M	11/15/2002	Within ten minutes of receiving DTaP #4, Prevnar #1 and Influenza #1 facial hives, erythema, several on back and two on abdomen. Site immediately at prevnar injection site slighty swollen and red. Rubbing face. Given orapred in office, Benadryl at home.									Y	11/14/2002	11/14/2002	0		PVT	PUB	Amoxicillin	Resolving cm	NONE			1						1	Erythema; Injection site hypersensitivity; Injection site oedema; Urticaria	DTAP~SMITHKLINE BEECHAM~572A2~4~~LL~DTAP (INFANRIX)~1|FLU3~PFIZER\WYETH~4020033~1~~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PNC~PFIZER\WYETH~490367~1~~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0194609	12/05/2002	OH	1.0	1	.0	M	12/04/2002	Atypical measles rash following MMR vaccine									Y	11/25/2002	12/03/2002	8		PVT	PVT	NONE	NONE	NONE			1						1	Rash	FLU3~SANOFI PASTEUR~UO956AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0770M~1~~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0788M~1~~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0194611	12/05/2002	UT		66		M	12/05/2002	Intense chills, muscles and joints, pains which lasted through the night and ended in the morning. headache									Y	12/03/2002	12/03/2002	0		UNK	UNK						1						1	Arthralgia; Chills; Headache; Myalgia	FLU3~SANOFI PASTEUR~UO883AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~080M~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194612	12/05/2002	MI	50.0	48		F	12/04/2002	At 9:10 AM, after receiving flu vaccine, patient stated that itching at the site almost immediately. Shortly thereafter, patient complained of 'itching around nose and mouth' and subsequent itchy throat and tongue. 9:25 am administered 0.3mm Epinephrine  1:1000 at site of flu vaccine injection SC. (* times approximate)				Y					Y	11/14/2000	11/14/2002	730	NONE	OTH	OTH	diovan	NONE	NONE			1						1	Injection site hypersensitivity; Pruritus	FLU3~SANOFI PASTEUR~UO958AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192882	12/06/2002	MD	83.0	83		F	12/02/2002	Information has been received from a registered nurse concerning an 83 year old retired White female with hypertension NOS, hyperlipidemia NOS, Type II diabetes mellitus, no known drug allergies and no illness at the time of the vaccination who on 10/28/02, was vaccinated with her first dose of pneumococcal vaccine 23 polyvalent, IM, in the left arm (lot 643782/0675M) and her second dose of influenza virus vaccine, IM, in the right arm (lot U0930F). Concomitant therapy included bisoprolol/HCTZ, metoprolol succinate, aspirin, raloxifene, vitamins, simvastatin, diazepam, celecoxib, glipizide, and pentoxifylline. On 10/29/02, the pt develoepd left arm cellulitis at the site of injection. The reaction size was shoulder to elbow 20x17cm, ruber, tumor and local aches. Additional information was received from the registered nurse who reported that the pt's left proximal arm developed an area of erythema measuring 20x17cm with increased heat, non-tender, normal strength and pulse. The pt did not develop a fever, chills or edema. The pt was diagnosed with elft arm skin reaction (cellulitis verses allergic reaction) after vaccination with pneumococcal vaccine 23 polyvalent and influenza virus vaccine. The pt was treated with Keflex, 50mg, four times a day and Benadryl, 25mg, every eight hours, as needed. On 10/31/02, the pt followed up with the physician and the left arm skin reaction (cellulitis versus allergic reaction) was much improved with only minimal erythema. The registered nurse reported that the pt required a doctor visit. The registered nurse reported the left arm skin reaction were considered to be other important medical events (OMIC). The registered nurse reported that there were three cases of site reactions. Two were unremarkable in nature (WAES0211USA01074).  No further info is available.				Y					N	10/28/2002	10/29/2002	1	UNK	PVT	PUB	Aspirin, Ziac, Celebrex, Valium, G0lucotrol XL, Toprol XL tablets, Trental, Evista, Zocor, vitamins (unspecified)		Hypertension, hyperlipidemia, type II diabetes mellitus		WAES0211USA00352	1						2	Feeling hot; Injection site erythema; Cellulitis; Injection site erythema; Injection site hypersensitivity; Injection site reaction; Injection site warmth	FLU3~SANOFI PASTEUR~U0930F~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0675M~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U0930F~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0675M~1~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0194213	12/06/2002	NM	58.0	58		F		Site of injection 2 in x 2.5 in  necrotic area- surgically removed 2 weeks later										11/13/2002	11/18/2002	5		PVT	UNK						1						2	Asthenia; Blister; Erythema; Headache; Oedema; Pain; Injection site necrosis	PPV~MERCK & CO. INC.~~1~~~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U0883AA  exp 06~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0445M  exop 03/~UNK~~LA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0194404	12/06/2002	MS	13.0	13		F	11/24/2002	Patients mother, which is a doctor, called reporting on 11/18/02 that patient was very weak and had temperature of 102.5 over weekend of the 15th - 17th of November 2002. On 11/19/02 doctor reported patient was doing much better and temperature in normal range.									Y	11/13/2002	11/15/2002	2	NONE	PVT	PVT	concerta	NONE	ADD, Asthmatic bronchitis		MS02038	1						2	Asthenia; Pyrexia; Asthenia; Pyrexia	FLU3~SANOFI PASTEUR~40971AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0735m~2~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U0971AA~6~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0735M~2~IM~RL~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0194613	12/06/2002	PA	40.0	40		M	12/04/2002	A nurse reported that a 40 year old pt received an injection of FluShield in the right arm on 10/28/02. On 10/31/02, the pt developed Bell's Palsy. This event is considered medically important (OMIC). No further info was available at the date of this report.									U	10/28/2002	10/31/2002	3	UNK	PVT	OTH	UNK	UNK	UNK		HQ5568902DEC2002	1						1	Facial palsy; Ear discomfort; Facial palsy	FLU3~PFIZER\WYETH~4020022~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4020022~7+~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0194613	12/06/2002	PA	40.0	40		M	12/04/2002	On 11/03/02, patient noticed symptom of blocked ear. On 11/13/02, patient consulted personal physician because blocked ear continued and got worse. Treated with antibiotic and decongestant. Contacted physician on 11/18 because symptoms continued. Personal physician prescribed Medrol dose pack. 11/19/02. patient experienced paralysis on right side of face. Patient visited family physician and was diagnosed with Bell's palsy. did improve gradually until today when patient states it has resolved. He states the only symptomn he has now is distorted taste.				Y					Y	10/28/2002	11/13/2002	16	HIV; Lyme disease test due to Bell's palsy	PUB	PUB	NONE	NONE	Seasonal allergies, retinoskesis			1						2	Facial palsy; Ear discomfort; Facial palsy	FLU3~PFIZER\WYETH~4020022~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|FLU3~PFIZER\WYETH~4020022~7+~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0194615	12/06/2002	CA	69.0	68		F	12/01/2002	Patient attended by her physicians; admitted to hospital. We are not aware of diagnosis.					Y				U	10/28/2002	11/01/2002	4		OTH	PVT		UNK				1						1	Myelitis; Unevaluable event	FLU3~EVANS VACCINES~30432GA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0194617	12/06/2002	CA	58.0	58		F	11/22/2002	Fever & aches developed around 2 pm, Lasted thru 9 pm approx. Injection site inflammed and swollen. took Ibuprophen for fever, liquids to flush system, sleep & rest.									Y	11/17/2002	11/17/2002	0		OTH	OTH	Potassium, Vitamin E, Multivitamin (Centrum, HZT 25 mg, Adalat CC	Cough, Congestion	Cough congestion, Upper Respiratory illness			1						1	Injection site inflammation; Injection site oedema; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0194631	12/06/2002	FL	76.0	76		F	11/27/2002	Light headed, nausea/vomiting upon arrival at home. 10/29/2002 after vaccine given in office- family called 911- Pt's daughter called later next day and said pt did not have to be transported to ER- felt better when paramedics arrived. No further symptoms.									Y	10/29/2002	10/29/2002	0	NONE	PVT	PVT		NONE	Allergic to Penicillin			1						1	Dizziness; Nausea; Vomiting	FLU3~EVANS VACCINES~E32072GA~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0194632	12/06/2002	AZ	80.0	80		F	10/22/2002	Left upper had redness, hot, cellulitis										10/21/2002	10/21/2002	0	NONE	PUB	PVT	NONE	NONE	Multi allergy shots		AZ0223	1						1	Cellulitis; Injection site erythema; Injection site reaction; Injection site warmth	FLU3~SANOFI PASTEUR~U0883AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1051L~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194633	12/06/2002	AZ	40.0	40		F	10/22/2002	Body rash, increased itching all over body									U	10/12/2002	10/18/2002	6	NONE	PUB	PVT	NONE	NONE	NONE		AZ0224	1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U0883AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194634	12/06/2002	NJ	72.0	72		F	11/30/2002	Arm swelled with fluid and pain. Had to go to family doctor and was put on antibiotic for 10 days. Had cellulitis. It was pneumonia shot.  Follow up on 01/03/2002: This was given at church.  do not have any other information.				Y					Y	11/07/2002	11/07/2002	0	Cellulitis	PUB	UNK		NONE	NONE			1						1	Cellulitis; Fluid retention; Injection site oedema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0194635	12/06/2002	MI	54.0	54		M	11/20/2002	Prolong pain (slight) at injection site. Muscle soreness from injection site to above elbow. Worse when I awake, gets better as the day goes on.									N	10/06/2002	10/06/2002	0		MIL	UNK		NONE	NONE			1						1	Injection site pain; Myalgia	FLU3~SANOFI PASTEUR~U0983AA~1~SYR~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194636	12/06/2002	SC	54.0	54		M	11/25/2002	c/o burning at injection site (1030); c/o dizziness, pale, diaphoretic, BP 92/60, p 38 (1040); Feet increase , BP 102/68, P 44, R20 (1042); P48R118, BP120/80 (1045);P60, R18BP140/92 (1047); Client with continued c/o dizziness, no diaphoresis; Client taken to MD office by son; Client denies Hx diabetes- reports didn't eat breakfast; Client reports Hx hypertension and currently has hiatel hernia that causes pain. 11/25/2002 Client did not complete consent for physician records to be obtained; Client did not agree for his RN to phone physician office and request a written documentation stating he couldn't receive the Flu vaccine; Client did report that MD instructed him not to take the Flu vaccine in the future; Client reports that MD told client that he remembered client coming to the MD office after receiving last years dose of the Flu vaccine and having a problem with the vaccine; When this RN questioned client, he couldn't recall what type of problem he had last year with the vaccine; Client did not indicate any problems with past Flu vaccines at the time of vaccine administration on 10/18/2002; When this RN spoke with MD office nurse on 10/18/2002, she also verbalized that MD instructed client not to receive the Flu vaccine in the future since client had a similar episode with injection in the past; Client has had continued problems with hypertension during the past month requiring his medication to be changed and / or adjusted 3 times; Client also had hypoglycemic episode that MD office identified on 10/18/2002 during his visit just after the Flu vaccine; Client reports no further episodes of hypoglycemia; Client is under continued care of family physician, related to his health issues, including blood pressure regulation.				Y					Y	10/18/2002	10/18/2002	0		PUB	PVT	Atenolal	Hiatel Hernia with pain awakening client at night	hypertension		SC0256	1						1	Dizziness; Hyperhidrosis; Injection site pain; Pallor	FLU3~SANOFI PASTEUR~U0926CA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0194637	12/06/2002	WI	3.0	3		M	11/21/2002	Received 1st flu vaccine on 11/20/2002 at apprx. 2:15pm. Developed red pin-point raised itchy rash to entire back area on 11/21/2002 at apprx. 1:00pm. Rash extending from scapula to low back. No breathing difficulties. Rash resolving after Benadryl. Responded well to Benadryl									Y	11/20/2002	11/21/2002	1		PVT	UNK	Patanol opthalmic	Allergic Conjunctivitis	Allergy- PCN Asthma			1						1	Rash erythematous; Rash pruritic	FLU3~SANOFI PASTEUR~U0909AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194638	12/06/2002	SC	69.0	69		F		Client received Td in left deltoid on 11/19/2002. Soreness noted day following injection. Also some slight body achiness and some itching in injection area. On 11/23/2002 client noticed redness extending from deltoid area to interior side of arm covering area from axilla to six inches below. Recovering; client spoke with her MD. they advised to just watch.										11/19/2002	11/23/2002	4	NONE	PUB	UNK					SC0255	1						1	Injection site erythema; Injection site hypersensitivity; Injection site pain; Pain; Pruritus	FLU3~PFIZER\WYETH~4020027~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~SANOFI PASTEUR~U0820AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0194640	12/06/2002	PA	52.0	52		M	11/26/2002	Complained of dizziness, nausea and headache after receiving flu shot.  10:35 BP Right 120/86, Left 130/86 Pulse 80. 11:00 BP Left 120/86, Right 140/80, Pulse 70									Y	11/07/2002	11/07/2002	0	NONE	OTH	PUB	UNK	NONE	NONE		PA0248	1						1	Dizziness; Headache; Nausea	FLU3~PFIZER\WYETH~4020026~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0194641	12/06/2002	PA	29.0	29		F	11/26/2002	Fellow employee called for client complained of dizziness, arm pain and feeling like she could pass out. Went to smoke cigarette - heart rate increased, nausea, and lightheadedness. Advised to call police to evaluate. Tylenol or Ibuprofen for sore arm. Suggest ER.									U	11/19/2002	11/19/2002	0	NONE	OTH	PUB	UNK	NONE	UNK		PA0247	1						1	Dizziness; Heart rate increased; Malaise; Nausea; Pain	FLU3~PFIZER\WYETH~4020026~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0194642	12/06/2002	PA	27.0	27		F	11/26/2002	10:15 Complained of throat feeling numb; able to speak; no lightheadedness. Had shot 45 minutes prior to episode. 11:30 no shortness of breath or palpitations. Numbness on left side of throat only. Feeling a little better since she took an advil.									Y	11/12/2002	11/12/2002	0	NONE	OTH	PUB	UNK	NONE	UNK		PA0246	1						1	Hypoaesthesia	FLU3~PFIZER\WYETH~4020026~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0194643	12/06/2002	PA	43.0	43		F	11/26/2002	Complained of not feeling well; site sore and swollen, little itchy, heart racing. HR 100; BP 150/80 Right; EMT called. 9:50 HR 120; 9:55 BP 140/80 Right; 10:00 BP 144/82, HR 88. Oxygen mask on - feels faint. Heart rate up when ambulance arrived; transferred to ER via ambulance.				Y					Y	11/12/2002	11/12/2002	0	NONE	OTH	PUB	Yentolin inhaler, Uniphyl	NONE	Asthma, Allergy to iodine and shellfish		PA0245	1						1	Heart rate increased; Injection site oedema; Injection site pain; Malaise; Pruritus	FLU3~PFIZER\WYETH~4020026~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0194644	12/06/2002	FL	55.0	55		F	12/02/2002	11/5/02 Patient had complaint of dizziness and flu-like symptoms; denied rash, fever or difficulty breathing.									Y	11/05/2002	11/05/2002	0	NONE	PUB	UNK	Celexa	Depression	Depression, Suicidal ideation			1						1	Dizziness; Influenza like illness	FLU3~SANOFI PASTEUR~U0591BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0445M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194646	12/06/2002	CO	2.7	2	.7	F	11/09/2002	Patient received DTaP #4 in right thigh IM and flu vaccine in left thigh IM on 11/6/02. Local reaction vs. celulitis due to DTaP. Presented to office 11/8/02 with complaints of 2.5 inch diameter redness and swelling at injection site right thigh.									Y	11/06/2002	11/08/2002	2	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Cellulitis; Injection site erythema; Injection site reaction; Injection site swelling	DTAP~SMITHKLINE BEECHAM~575A2~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U0940AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194647	12/06/2002	CA	54.0	54		F	11/25/2002	Localized urticaria, pruritis around immunization site occurring within 48 hours of injections.									Y	11/05/2002	11/07/2002	2	NONE	PVT	PVT	Fosomax	NONE	Sulfa, Penicillin			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0920AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~SMITHKLINE BEECHAM~710A4~1~~RA~HEP A (HAVRIX)~1|TD~SANOFI PASTEUR~U0524AA~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0194648	12/06/2002	AZ	51.0	51		F	11/30/2002	Hives. Doctor treated with antibiotics.									Y	11/13/2002	11/14/2002	1	NONE	OTH	PVT		NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U0879AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194649	12/06/2002	RI	7.0	7		M	11/27/2002	12 hours after injection, fever, chills, aches, headache, nausea, vomiting, sore throat lasting for 3 days.				Y					Y	11/19/2002	11/20/2002	1		PVT	UNK	Singular		Asthma			1						1	Chills; Headache; Nausea; Pain; Pharyngolaryngeal pain; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0194650	12/06/2002	PA				F	11/27/2002	Lump and soreness right arm injection site after 2 weeks.														PVT	OTH						1						1	Injection site mass; Injection site pain	FLU3~SANOFI PASTEUR~U0945AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194651	12/06/2002	VA		60		M	11/25/2002	Received shot on 11/12. On evening 11/19 developed pain and swelling in hands, wrists and left knee. When became painful, saw doctor Thursday afternoon 11/21. Diagnosed as Reactive Synoidritis, prescribed Zorprin. Severe symptoms until 11/23. Friday evening 11/22 left deltoid swelled.				Y					U	11/12/2002	11/19/2002	7		UNK	UNK		NONE	NONE			1						1	Joint swelling; Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~V0913AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0194652	12/06/2002	OR	41.0	41		F	11/14/2002	Joint pain and swelling the following day. Continued through 11/12/02.									Y	11/06/2002	11/07/2002	1		OTH	PVT	NONE	NONE	NONE			1						1	Arthralgia; Joint swelling	FLU3~EVANS VACCINES~E33402HA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0194653	12/06/2002	MD	64.0	64		F	11/26/2002	Patient developed hives after flu shot. To ER; Benadryl given. To PMD; steroid and medication given. To dermatologist.				Y					Y	11/15/2002	11/18/2002	3	NONE	PUB	PUB	Thyroid	NONE	Hypothyroidism			1						1	Urticaria	FLU3~PFIZER\WYETH~4020026~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0194654	12/06/2002	SD	40.0	42		F		5 hours after I got flu shot, I was changing my shirt and seen rash on front of torso. They got worse 10/29/02. I went to friend again that same evening; I got more on back of legs. I called to report on 10/30/02.									Y	10/28/2002	10/28/2002	0		PUB	UNK		NONE	NONE			1						1	Rash	FLU3~PFIZER\WYETH~4020030~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0194655	12/06/2002	KY	59.0	59		F	12/01/2002	Patient called 1 week after receiving injection, started experiencing pain and tingling in left arm, lower back and left hip and leg. Received steroid Rx from physician and symptoms are still persisting at this time.				Y					U	11/08/2002	11/14/2002	6		PUB	PUB	Cardizen, Premarin, ASA, Prilosec, Zoloft, Xanax, Pepcid, Sleeping Pill, Prednisone	Lupus	PCN, Tetracycline, Latex			1						1	Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U0886AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0194692	12/06/2002	TX	4.0	4		M	12/06/2002	CHEST TIGHTNESS  SOB, SWELLING OF THROAT, DIFF BREATHING  HIVES AND ITCHING  EPINEPHRINE 1:1000  .2CC SUBQ  AT ER BENEDRYL 25MGS Q 4-6 HOURS				Y					Y	12/06/2002	12/06/2002	0		PVT	PVT						1						1	Chest discomfort; Dyspnoea; Pruritus; Urticaria	DTAP~SANOFI PASTEUR~U0848DA~5~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U0945AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0364M~1~IM~LA~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~W0196~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0858M~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0194697	12/09/2002	NY	2.75	2	.8	M	12/05/2002	Per mom eyelids and ears were swollen. Pt had a generalized urticarial rash over the body and face. Per mom she gave Tylenol at 6am on 12/5/02 because pt felt real hot. Benadryl was given at office visit on 12/5/02. Vaccine administered was 1st half of split dose.				Y					Y	12/04/2002	12/05/2002	1		PVT	PVT	Albuteral sulfate, Pulmocort	NONE	NONE			1						1	Body temperature increased; Eyelid oedema; Oedema; Urticaria	FLU3~SANOFI PASTEUR~U0951AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0194738	12/09/2002	WA	31.0	30		M	12/09/2002	I had immediate swelling in the proximate lymph node (left armpit) up to approximately grape size.  Swelling and localized pain did not abate until 3 days later.  Lymph node returned to normal size one week later.									Y	11/26/2002	11/26/2002	0	n/a	UNK	UNK	None.	None.	None.			1						1	Lymphadenopathy; Oedema; Pain	FLU3~SANOFI PASTEUR~U0958AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194704	12/10/2002	WA	1.3	1	.4	F	12/09/2002	Rash, fever, petechiae--scattered throughout body; pruritic lesions. 1 hour after shots started fever, fussy. Woke up during night noted a fever and spots scattered throughout body. Meningococcemia.			Y	Y	Y				Y	12/06/2002	12/06/2002	0	Spinal tap, CBC, Blood culture negative to date.	PVT	PUB	NONE	NONE	NONE			1						1	Arthritis; Cryptococcosis; Meningitis; Petechiae; Pyrexia; Rash; Skin ulcer	DTAP~SMITHKLINE BEECHAM~573A2~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U0932AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0194705	12/10/2002	HI	56.0	56		M		Severe pleurisy. Complication of bacterial pneumonia.			Y	Y					Y	11/30/2002	12/03/2002	3		UNK	UNK	Allegra, Naproxin	Recovery from pneumonia	Bronchiectasis, Aspergellosis, Rheumatoid acid			1						1	Bacterial infection; Pleurisy	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0194724	12/10/2002	OR	82.0	82		M	12/02/2002	Probably Guillen Barre onset 11/26/02. Upper respiratroy tract infection approximately 1 week prior to admit, was febrile illness with sore throat. Resolved for 3-4 days prior to onset of symptoms. 11/23-24 normal health. 11/26 upper extremity tingling, felt weak. 11/27 upper extremity tingling, extremely weak, lots of phlegm, admit to hospital with presumed Guillen Barre. 11/28 intubated secondary to unable to protect airway. 11/29 significantly weaker. 11/30 communicates with notds, blinks, able to move arms, legs, some grip. Hypertension becoming a problem. 12/3 hypertension still a problem, probably secondary to agitation, as blood pressure decreases significantly with versed and morphine. 11/27 IVIG 400 mg/kg/day x 5 days started. 12/3 hypertensive meds nitropaste half inch q6h, zestril 80mg qday, lopressor 100mg po bid, clonidine .2mg po qday, Morphine and versed IV prn. Still paralyzed, intubated, unable to eat = tube feedings, DC to long term nursing home. Follow up states: Pt has not recovered. Still paralized, intubated, unable to eat- tube feedings, DC to long term nursing home. Annual follow up on 12/24/03: It is unknown if the vaccine recipient has recovered from the adverse events that were reported for this vaccination.			Y	Y	Y				N	11/02/2002	11/26/2002	24	11/27 sed rate 37; 11/29 CSF negative for malignant cells, glucose 90, protein 37, WBC 3, segs 100%, CSF culture negative; 11/27 spinal CT C6-7 partial fusion, probably congential, degenerative spondyloisis C4-5, no observed cord abnormalit	OTH	PVT	Procardia XL, Toprol XL, Maxzide, sulfasalazine, Zestril		Previous medical history includes malignant lymphoma; lumbar region lytic lesions; Associated with right lower extremity weakness; mastoid surgery with decreased hearing on left; prostate resection; angioplayst; ulcerative colitis.			1						1	Guillain-Barre syndrome; Hypertension; Paraesthesia; Paralysis; Pyrexia; Upper respiratory tract infection	FLU3~EVANS VACCINES~E34112HA~1~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0194725	12/10/2002	MO	41.0	41		F	11/15/2002	Received vaccine at 14:00. At 14:35, felt dizzy, weak, some tingling of face and upper trunk, tongue felt thick and had difficulty swallowing. No frank urticaria. Given epinephrine, Benadryl and Solu-Medrol and admitted for observation.				Y	Y				Y	11/05/2002	11/05/2002	0	P 92, BP 110/52; Lungs,clear; Head, eyes, ears, nose, throat normal.	PUB	PUB	NONE	NONE	NONE			1						1	Asthenia; Dizziness; Dysphagia; Paraesthesia; Tongue disorder	FLU3~EVANS VACCINES~E35802KA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0194726	12/10/2002	OR	67.0	67		M	11/29/2002	Death certificate received on 2/5/2003 indicates GBS as the cause of death.	Y	12/04/2002	Y	Y	Y				N	10/19/2002	11/08/2002	20		PVT	UNK						1						1	Balance disorder; Dysphonia; Guillain-Barre syndrome; Hypoaesthesia; Hyporeflexia	FLU3~SANOFI PASTEUR~U0875AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0194727	12/10/2002	OH	71.0	71		F		Have received 5 previously and no adverse reaction. Flu shot was administered on Saturday morning, November 1, 2002, at about 10:30am. About 8:30pm had a hard time breathing and tightness in the chest. Slight fever and nausea. Took two aspirin and went to bed about 10:00p.m. Sunday morning. got up about 7:00am felt fine. About 3:00pm the tightness started in my chest. Slight fever and nausea. Read instruction for flu shot and symptoms sounded like reaction. Relieved a little in afternoon. Started again about 8:00pm. Took two aspirin went to bed. Monday morning felt fine. Called the Doctors office. told the nurse what had happened and she said she would tell the doctor and get to me. I felt fine all day. About 2:00am the tightness was so bad it woke me up. Took two aspirin and it finally relieved in about three hours. Tuesday, went to the doctors office at 2:40pm. Checked over and had EKG. Things looked normal. Given a prescription for Nitro pills. he said if it happens again to take 1 pill and if not relieved, take another five minutes if not relieved take another one and if not relieved in 5 minutes call 911. felt fine rest of day. Wednesday, felt fine. Went to work and about 4:00pm it started again. Went home about 5:00 and fell asleep. Husband woke me about 5:45pm I still had tightness which was worse. Took one pill, not better, took another one, and still not better. Took the third and when it did not get better, my husband called 911. The rescue squad said I was not having a heart attack, but with pressure so great, the took me to Mount Carmel Emergency Room. They put me on IV and Nitro IV and monitored me. Started to get relief about 12:30am. Was admitted and was scheduled to have a Cardiolite treatment on Thursday morning. November 21, 2002 I have felt alright. For about a week after I have been nauseous and very tired and weak. Started feeling better about Saturday, November 30.				Y	Y	1			Y	11/16/2002	11/16/2002	0		OTH	UNK	Hmulin, Metromin, Norvasc, Indapamide	NONE	Hayfever, Diabetic, high blood pressure, Demerol - makes n/v			1						1	Angina pectoris; Chest discomfort; Dyspnoea; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~U0938AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0194733	12/10/2002	IL	53.0	53		F	11/27/2002	Our patient had a flu shot on 10/25/02. On Sunday night, 10/27/02 she went out to eat for her meal. She ordered chili and a double cheeseburger. Later that evening she started throwing up. Patient said she vomited so much and so many times, patient felt she lost 8 pounds from all her vomiting. Our patient also developed some nasal congestion and a raspy sounding voice. She went to work on Monday, developed a fever which lasted for 24 hours. Tuesday patient felt better and returned to work. Patient wonders if this was allergic reaction or some type of reaction or if she is allergic to virus.									Y	10/25/2002	10/27/2002	2	NONE	OTH	PVT	NONE					1						1	Dysphonia; Nasal congestion; Pyrexia; Vomiting	FLU3~EVANS VACCINES~E31192HA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0194734	12/10/2002	OH	48.0	48		M	11/25/2002	Flu shot administered in right deltoid--sore at injection site same day. Next day progressed to swelling under arm at right axillary--generalized swelling, not large nodule. Patient stated not hot or red; just painful and swollen. Encourage patient to see physician.									Y	11/22/2002	11/23/2002	1		PUB	PUB	NONE	NONE	Allergy PCN, Anaphylactic, Hives from sulfa drugs		OH0049	1						1	Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U0938AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194735	12/10/2002	NV	73.0	73		F	12/04/2002	Patient complained of progressive pain and weakness in right arm starting about 1 week after flu shot. Patient is now unable to hold her arm up away from her body higher than elbow level without support. The pain now radiates to right shoulder, neck and lateral chest. No fever or redness at injection site; mild persistent swelling noted.				Y					N	11/15/2002	11/22/2002	7	11/30/02 X-rays of right shoulder, neck and arm - diagnosis arthritis per patient.	OTH	PVT	NONE	NONE	Allergy to prednisone			1						1	Arthritis; Asthenia; Pain; Swelling	FLU3~SANOFI PASTEUR~U0926EA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0194736	12/10/2002	AZ		56		F	12/05/2002	Woke up sick on 11/21/02, day after shot, felt sick and weak and warm. Stayed in bed for 2 days. Took Tylenol x2. Also had upset stomach; didn't vomit. Also had 3 years ago and got sick like that (flu shot).									Y	11/20/2002	11/21/2002	1	NONE	OTH	PUB	Potassium; Glyburide; Hydrochlorothimide; Lisinopril, Calcium	NONE	NKA; DM, HTN	Same as above~Influenza (Seasonal) (no brand name)~~52.00~In Patient		1						1	Asthenia; Feeling hot; Malaise; Stomach discomfort	FLU3~PFIZER\WYETH~4020033~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0194737	12/10/2002	KY	36.0	36		M	11/26/2002	Tingling in extremities; redness all over face, neck, etc... Client complained of tightness in throat. The symptoms developed over 3 hours. Patient was treated at ER for allergic reaction to flu shot.									Y	11/21/2002	11/21/2002	0	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Flushing; Hypersensitivity; Paraesthesia; Throat tightness	FLU3~SANOFI PASTEUR~U0886AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194740	12/10/2002	MS	83.0	83		F	12/06/2002	approx 3 min after flu and pneumonia injections, patient had nausea and headaches, nail beds cyanotic Blood pressure 250/120 pusle 120				Y					Y	12/06/2002	12/06/2002	0		PUB	PUB	zestrel	Hypertension	HVD		ms 02 042	1						1	Cyanosis; Headache; Nausea	FLU3~SANOFI PASTEUR~U0971AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0710M~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0194741	12/10/2002	KY	46.0	46		F	11/26/2002	Burning when shot was given. Later a blister formed at the site of injection and fluid drained from the site. Client developed a rash over her arm and stomach. Private doctor treated patient for allergic reaction to flu shot and recommended no flu shots in the future.									Y	11/21/2002	11/21/2002	0	NONE	PUB	PUB	UNK	NONE	NONE			1						1	Hypersensitivity; Injection site inflammation; Injection site vesicles; Rash	FLU3~SANOFI PASTEUR~U0886AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194744	12/10/2002	CA	41.0	41		F	11/13/2002	URI symptoms began on or about 11/6 progressing to asthmatic bronchitis on 11/13/02 with known history of asthma. Continue with asthma symptoms and swollen left thigh for ? exposure. Fever at times.									Y	10/23/2002	11/06/2002	14	NONE	PVT	UNK		NONE	Asthma			1						1	Asthma; Pyrexia; Swelling; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~U0968AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194748	12/10/2002	VA	3.0	3		F		Flu like symptoms with aches, fever, stomach ache, fatigue, congestion, cough.									Y	11/18/2002	11/19/2002	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Abdominal pain upper; Cough; Fatigue; Influenza like illness; Nasal congestion; Pain; Pyrexia	FLU3~PFIZER\WYETH~4020024~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0194750	12/10/2002	TX	78.0	79		F	12/03/2002	3.5 cm X 5 cm, erythema induration, left deltoid, red, hot itchy									Y	12/02/2002	12/02/2002	0	NONE	PVT	PVT	Atacano, Levoxyl, Miacalcum, Antivert, Levoxyl	HTN	Celebrex			1						1	Injection site erythema; Injection site hypersensitivity; Injection site induration; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~UO982AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194753	12/10/2002	IA	81.0	81		F	11/13/2002	Rash and hives starting 8 days after flu shot on arms and trunk. Still has hives-started last night.									N	11/04/2002	11/12/2002	8	NONE	PUB	PUB	Ticlid, ASA, Combivent inhaler-all same/unchanged	NONE	TIA, COPD			1						1	Rash; Urticaria	FLU3~PFIZER\WYETH~4020004~5~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0194754	12/10/2002	NY	43.0	43		F	12/02/2002	Hives for 4 days. My doctor prescribed Hydroxyzine HCL 25mg tb. 1 tablet every 8 hrs.				Y					Y	11/13/2002	11/14/2002	1		OTH	OTH	Advair, Diskus 250/50, Depoprovera	NONE	Mitral valve prolapse, asthma			1						1	Urticaria	FLU3~SANOFI PASTEUR~U0936FA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0194759	12/10/2002	FL	4.0	4		F	12/04/2002	Redness, swelling L arm noted this AM low grade fever.				Y					U	12/03/2002	12/04/2002	1		PVT	PUB	NONE	NONE	Asthma			1						1	Injection site erythema; Injection site oedema; Pyrexia	DTAP~SMITHKLINE BEECHAM~571A2~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U0936FA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~U0199~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0351M~3~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0194876	12/10/2002	NY	39.0	39		F	12/10/2002	Pt reported localized discomfort at the injection site and swollen gland in the left axilla.  Discomfort was eased with advil and discomfort and swelling gradually subsided.									Y	11/06/2002	11/07/2002	1	none	PVT	PVT	none	Pt stated she was nearly over a cold.	none			1						1	Discomfort; Injection site reaction; Lymphadenopathy	FLU3~SANOFI PASTEUR~00969AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194811	12/11/2002	TX	22.0	22		F	12/05/2002	Patient's arm was tingling, chest began to tighten. She began to black-out. Gave two 0.3 EPI pen shots. The adverse events began 3-4 minutes after the shot.				Y					Y	12/05/2002	12/05/2002	0		OTH	OTH	Orthotrycycline	NONE	NONE			1						1	Chest pain; Paresis; Syncope	FLU3~SANOFI PASTEUR~U0922AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0194812	12/11/2002	OH	49.0			M		Developed erythema at site of injection. Site indurated and tender. Blanches. Given Tylenol. 6cm erythema. Applied thin film of cortinzone to area. 11/23/02 right upper arm erythema faded and down in cm. Overall about 1cm on each side less comfort.											11/18/2002			OTH	OTH			Diabetes, HTN, Paralyzed vocal cord, cardiac surgery, Pneumonia 5/2002; allergy to demerol			1						1	Injection site hypersensitivity; Injection site mass	FLU3~SANOFI PASTEUR~U0877AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194813	12/11/2002	NE	56.0	56		F	12/06/2002	Headache, low grade temp (101.4 highest), diarrhea. Had injection Tues. 10/22, symptoms began Monday 10/28 with persistence 10/30 and 10/31. Treatment; Motrin. Worked Monday, returned to work Thursday with complete recovery.									Y	10/22/2002	10/28/2002	6	NONE	PUB	PUB	PremPro	NONE	NONE	same~Influenza (Seasonal) (no brand name)~~55.00~In Patient		1						1	Diarrhoea; Headache; Pyrexia	FLU3~SANOFI PASTEUR~U0928AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194814	12/11/2002	AR		26		F	11/04/2002	Apprx. 10 min after receiving the flu vaccine in her left arm, pt c/o itching. Her injection site was hot, red apprx. 8cm around site. No other c/o. No respiratory distress, N+ V. R 18-20 P72/80. Ice pack to site. Tylenol tab 500mg /tab. Benadryl 50mg-po observed for 30 mins.									Y	11/04/2002	11/04/2002	0	NONE	OTH	PUB		NONE	NONE		AR0263	1						1	Injection site erythema; Injection site hypersensitivity; Injection site warmth; Pruritus	FLU3~PFIZER\WYETH~U09870102~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0194815	12/11/2002	AR	18.0	18		F	11/07/2002	Got Influenza vaccine at 3:15pm 11/06/2002. Started itching at 6:30 pm and rash noticed 7:30pm. First developed small red hive left inner knee then it got larger in circular size and right knee hives appeared. took Benadryl 25mg at 11 pm. 11:30 rash over body, arms , and legs.				Y					Y	11/06/2002	11/06/2002	0	NONE	OTH	PUB	Antibiotic 2 weeks- UTI. Ortho Tricyclen	NONE	Penicillin, Wasps		AR0264	1						1	Pruritus; Rash; Rash erythematous; Urticaria	FLU3~PFIZER\WYETH~4020008~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0194816	12/11/2002	OH	42.0	42		F	11/18/2002	11/13/2002- day following flu shot, client reported that she developed a 2in circular red area at injection site- warm to touch, no pain. On allergy shots and weaning off at time of injection. Took Benadryl BID and used Cortisone Cream on area. 11/14/2002 c/o generalized aching, low grade temp, and flu like symptoms and took Tylenol. 11/15/2002 Feels better and redness in arm subsided. 11/20/2002 completely recovered.									Y	11/12/2002	11/13/2002	1		PUB	UNK	Clarinex, Citranal D	NONE	Allergies- ragweed, pollen, codeine		OH0048	1						1	Influenza like illness; Injection site erythema; Injection site warmth; Pain; Pyrexia	FLU3~EVANS VACCINES~E32072GA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0194817	12/11/2002	VA	75.0	75		F	12/05/2002	Red rash, large swelling on right arm from elbow to shoulder and almost around arm. About 1 in from touching- very sore, painful. Temp 101.5 degrees- chills, felt very ill- To doctor 2 days.									Y	10/21/2002	10/21/2002	0		PUB	PUB	Cozaar, Synthroid, Prem, Nornasc	Heart, High Blood Pressure, Hythroid hypo	High blood pressure, Thyroid, Heart (ETR)			1						1	Chills; Injection site erythema; Injection site oedema; Injection site pain; Injection site rash; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0194818	12/11/2002	FL	71.0	71		F	11/25/2002	Blurry vision, severe sweating, weakness- passed out. Rapid breathing/wheezing- very weak- very itchy skin (on hands only). Pt started feeling a little better about 09:30pm on 11/20/2002. About 2 days ;later Pt was ok.									Y	11/20/2002	11/20/2002	0		PVT	UNK	Enalprit, Maroxen, Quinine Sulfate	NONE				1						1	Asthenia; Hyperhidrosis; Respiratory rate increased; Vision blurred; Wheezing	FLU3~SANOFI PASTEUR~U0931AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194819	12/11/2002	AK	4.0	4		F	12/05/2002	Swollen, red, warm right arm									U	11/25/2002	11/26/2002	1	NONE	PVT	PVT		NONE	Hearing loss, Recurrent UT, decrease muscle tone trubnk			1						1	Feeling hot; Injection site erythema; Injection site oedema	DTAP~SMITHKLINE BEECHAM~575A2~5~IM~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U0885A2~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W0010~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0194820	12/11/2002	IN				F	12/02/2002	Persistent right shoulder pain for at least 1 week. Decreased range of motion				Y					N	11/26/2002	11/26/2002	0		PUB	PUB		NONE	NONE			1						1	Joint range of motion decreased; Shoulder pain	FLU3~SANOFI PASTEUR~U0911BA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0194821	12/11/2002	CA	47.0	47		F	11/27/2002	Injection site was red and warm. Pt felt cold and also complained of body aches. Swelling at injection site.									Y	11/25/2002	11/25/2002	0	NONE	PUB	PVT	Prozac	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site warmth; Pain	FLU3~EVANS VACCINES~E35462HA~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0194822	12/11/2002	IL	65.0	65		M	12/04/2002	With in 5-10 mins of receiving vaccine, pt became extremely nauseated and tired. bottomed out. He vomited in the ER, broke out in a cold sweat. ER MD said episode was not related to vaccine.				Y					Y	12/04/2002	12/04/2002	0	EKG, BS, BP all wnl	PUB	PUB	Prilosec, KCI, Glucatrol XL, Coumodin, Glucophage, HCTZ, Monopril, Furosemide, Norvac	NONE	Diabetes, TIA's, Hypertension			1						1	Fatigue; Hyperhidrosis; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U0886AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0194823	12/11/2002	MA	9.0	9		F	12/04/2002	Three hours after vaccine administered developed hives generally; afebrile, hive for one week even on Benadryl. Zyrtec stared day six with better results; arm swollen at injection site.									U	11/25/2002	11/25/2002	0		PVT	PVT	Singulair, Flovent, Rhinocort, Albuterol, Zyrtec	NONE	Asthma, Environmental and dust allergies			1						1	Injection site oedema; Urticaria	FLU3~SANOFI PASTEUR~U0879AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194824	12/11/2002	OH	1.0	1	.0	M	12/05/2002	Swelling of eyelids and upper lip thirty minutes after immunizations. Hives four hours after shots. Received Benadryl thirty minutes after beginning of symptoms. No respiratory distress, ul VS				Y					Y	12/02/2002	12/02/2002	0		PVT	PVT	Tylenol	NONE	Eczema			1						1	Face oedema; Urticaria	FLU3~SANOFI PASTEUR~U0941AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0632M~1~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0803M~1~SC~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0194825	12/11/2002	IL	67.0			M	10/29/2002	About supper time arm felt sore and started swelling, redness to elbow right arm, three fingers feeling numb. About 10pm started chills, no temperature, hallucinating, thought he was in shed at work although he is retired. Thought he had respiratory problem. Wanted to take him to emergency room about 3am, but he refused. He was better by morning and only felt tired and weak but did not call ? related by wife. 10/29/02									Y				NONE	PUB	PVT		NONE	NONE			1						1	Hallucination; Myalgia; Oedema; Paraesthesia	FLU3~SANOFI PASTEUR~U0903AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1159L~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194826	12/11/2002	IL	27.0	27		F	12/04/2002	Patient was given Pneumo vaccine left arm 12/3/02. Patient called clinic 12/4/02 next day stating left arm red with rash and hurt a lot. Patient was told to apply ice pack, take Tylenol. If not better RTC.									Y	12/03/2002	12/04/2002	1		PVT	UNK						1						1	Pain; Rash; Vasodilation procedure	FLU3~EVANS VACCINES~E33902HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0955M~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194827	12/11/2002	MI		45		F	12/02/2002	Began vomiting intensely on evening of 11/26/02. Aspirated and then went to ER.				Y					Y	11/26/2002	11/26/2002	0		PVT	UNK	Prilosec, Motrin, Ambion, Zestoretic	Back Pain	GERD, HTN, edema			1						1	Vomiting	FLU3~SANOFI PASTEUR~U0950AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0194828	12/11/2002	WI	36.0	36		F	12/04/2002	Partial facial numbness on the left middle of face starting 11-6-02 evening. ENT eval & MRI showed no signs of sinuse infection and MRI was normal.				Y					U	11/06/2002	11/06/2002	0		OTH	PVT	Multivitamins	NONE	NONE			1						1	Hypoaesthesia	FLU3~EVANS VACCINES~E35742KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0194829	12/11/2002	MN	34.0	34		M		12/4/02 Patient reports Pneumovax and flu shot given in left deltoid 12/2/02. He then had fever of 102, left shoulder pain, erythema, swelling and nausea.									U	12/02/2002				UNK	UNK						1						1	Erythema; Nausea; Oedema; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~SYR~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~SYR~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194830	12/11/2002	MA	71.0	71		F	12/05/2002	Red sore swollen right arm were PPV vaccine given (11/15/02) followed by few days later URI and cold cough, muscle aches and pains lasted ten days.									Y	11/15/2002	11/15/2002	0		PVT	UNK	URSO, Klonopin		Liver Disease, PBC, Osteoarthritis, osteoporosis			1						1	Cough; Injection site hypersensitivity; Injection site oedema; Myalgia; Pain; Upper respiratory tract infection	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0194831	12/11/2002	CA	49.0	49		F	10/29/2002	Within 15 minutes of vaccination, severe itching around vaccine site (4 diameter). Then sever itching on entire arm to fingertips. Thirty minutes later, small red dots on entire inside of arm. Itching and dots disappeared by next morning.									Y	10/23/2002	10/23/2002	0	NONE	OTH	PVT	NONE	NONE	Seasonal allergies			1						1	Injection site hypersensitivity; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0194832	12/11/2002	MN	62.0	62		F	11/29/2002	Dizziness and nausea around 8pm, 12 hours after vaccine. Effects lasted 1.5 days. No treatment									Y	11/18/2002	11/18/2002	0		PUB	UNK						1						1	Dizziness; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0194833	12/11/2002	NM	26.0			U		Severe pain radiating down arm and up to neck, starting ondate of injection 10/22/02 to the present (6 weeks) weakness 20/0 pain with lifting.									N					PUB	UNK	NONE	NONE	NONE			1						1	Hypokinesia; Injection site pain; Muscular weakness; Pain	FLU3~SANOFI PASTEUR~v0885AA~5~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194834	12/11/2002	IA	91.0	91		F	11/20/2002	Rash and hives on buttocks.									N	10/30/2002	11/02/2002	3	NONE	OTH	PUB	Avandia, Atenol, Imdur, synthorid, ASA, Lasix, Pepcid, Nitropatch, Aricept, Miconase		Diabetis, heart disease, CHF			1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~U0918AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194835	12/11/2002	MD	53.0	53		M	12/04/2003	Vaccine on 11/27/02. Starting next day, back aches (mid-back, below shoulders). Both sides, aches continued until today, 1 week later. Applied heat (heating pad), took Advil once, both gave temporary relief. Last two days, flu-like symptoms. No fever, no URI symptoms.									U	11/27/2002	11/28/2002	1	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Back pain; Influenza like illness; Pain	FLU3~SANOFI PASTEUR~U0958AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194836	12/11/2002	RI	3.0	3		F	12/04/2002	Redness and induration apprx. 2 in in diameter at site of injection. Resolved in 1 week.									Y	11/02/2002	11/02/2002	0		PVT	PUB		NONE				1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U0911BA  exp 06~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194837	12/11/2002	OH	57.0	57		F	12/04/2002	Pt states that L upper arm has ached like the toothache since she received the flu vaccine on 11/8/02.									Y	11/08/2002	11/08/2002	0	NONE	OTH	OTH	Anti-inflammatory	NONE	NONE			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U0921FA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194890	12/11/2002	TN	47.0	47		F	12/10/2002	Pt experienced a twinge as injection began followed by soreness, edema, lymphadenopathy, pain and numbness. Pt visited her doctor and symptoms improved with range of motion, heat ahd Naproxen, but did not resolve and have worsened as of 12/6/02.				Y					N	11/07/2002	11/07/2002	0	CBC performed-white cells not elevated.	PUB	PUB	Indurol, Aspirin (1x day)	Ear infectionand strep two weeks prior	Mitral valve prolapse, heart murmur, med llergies-sulfa, codeine, morphine, mepergam, Prednisol, metronidezole			1						1	Hypoaesthesia; Injection site erythema; Injection site oedema; Injection site pain; Lymphadenopathy	FLU3~PFIZER\WYETH~4020021~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0194891	12/12/2002	MA	73.0	73		F	11/25/2002	3 d. post immunization noted aches in both legs-progressing to arms and legs. Tx with ASA with relief. Pt advised by MD to d/c HCT 2.25mg qd started 1 mo age as well as notify health dept. Pt states is very sensitive to meds. Pt has rec'd flu vaccine x many years without effect.									N	11/09/2002	11/12/2002	3	NONE	PUB	PUB	HCT2 25mg qd	Back pain	NONE		MA0208	1						1	Pain	FLU3~SANOFI PASTEUR~U0879AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194907	12/12/2002	MS	35.0	35		F	11/23/2002	Headache, body chills, fever, body aches, sore throat, ears ringing/hurting, nausau				Y					Y	11/14/2002	11/16/2002	2	DX upper respiratory infection, fluid inboth ears.	UNK	UNK	none	none	none		ms 02 041	1						1	Chills; Ear pain; Headache; Nausea; Pain; Pharyngolaryngeal pain; Pyrexia; Tinnitus; Upper respiratory tract infection	FLU3~PFIZER\WYETH~4020030~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0194957	12/12/2002	SC	19.0	19		F	12/12/2002	Vaccines administered. Seen 2 days later with pain, swelling, erythema to right arm from shoulder to elbow.Vitals BP118/50,P85,R16,T98. RX- Zyrtex, Naproxan, Benadryl.Patient monitored-then dc'd. Bedrestx24 hrs. Seen for f/u next day with decreased symptoms.				Y					Y	12/09/2002	12/11/2002	2		MIL	MIL	none	none	none			1						1	Erythema; Oedema; Pain	FLU3~SANOFI PASTEUR~U957AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~234B6~1~IM~LA~HEP A + HEP B (TWINRIX)~1|MMR~MERCK & CO. INC.~0491M~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PPV~MERCK & CO. INC.~0710M~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0194958	12/12/2002	SC	19.0	19		F	12/12/2002	Vaccines administered. Seen 2 days later at 4th BAS with pain, swelling, erythema to right arm from shoulder to elbow. Vitals BP 192/86, P 104, R 16, T 99.1.RX- Ciproflaxin, Naproxan, Benadryl, Patient monitored-then dc'd.  Bedrestx24 hrs. Seen for f/u next day with decreased symptoms.				Y					Y	12/09/2002	12/11/2002	2		MIL	MIL	none	none	none			1						1	Erythema; Hypertension; Oedema; Pain	FLU3~SANOFI PASTEUR~U957AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~234B6~1~IM~LA~HEP A + HEP B (TWINRIX)~1|MER~MERCK & CO. INC.~0491M~2~SC~LA~MEASLES + RUBELLA (MR-VAX II)~1|PPV~MERCK & CO. INC.~0710M~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0194959	12/12/2002	SC	19.0	19		F	12/12/2002	Vaccines administered. Seen 2 days later at 4th BAS with pain, swelling, erythema to right arm from shoulder to elbow. Vitals BP 166/100, P 87, R 16, T 98.6. RX- Cephalexin, Atarax. Patient monitored-then dc'd.  Bedrestx24 hrs. Seen for f/u next day with decreased symptoms.				Y					Y	12/09/2002	12/11/2002	2		MIL	MIL	none	none	none			1						1	Erythema; Oedema; Pain	FLU3~SANOFI PASTEUR~U957AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~234B6~1~IM~LA~HEP A + HEP B (TWINRIX)~1|MER~MERCK & CO. INC.~0491M~2~SC~LA~MEASLES + RUBELLA (MR-VAX II)~1|PPV~MERCK & CO. INC.~0710M~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0194914	12/13/2002	CA	43.0	43		M	12/11/2002	2 days following the flu shot, developed numbness in right foot, numbness in both feet, hands legs. Weakness progressed to upper extremities, headache, pain over chest wall, rib cage, muscle across abdominal all and low back. Intubated and on ventilator.     60 Day Follow up States: Sorry do not have any follow up information on this pt post discharge from hospital     Per acknowledgement letter: Please note-this information was not available from the physician who gave the vaccine. Discharge summary states atrial fib.msv Medical recordsstates cellulitis, pneumonia, urinary tract infection, pancreatitis, aggrevation of previous condition, decreased reflexes, respitory failure, pleural effusion, abdomenal distention. msv			Y		Y				U	11/20/2002	11/28/2002	8	Medical records state bacterial infection, leukocytosis. msv	PVT	PVT		NONE	Asthma Medical records state alcohol dependance, pancreatitis. msv			1						1	Abdominal distension; Abdominal pain; Apnoea; Asthenia; Bacterial infection; Cellulitis; Condition aggravated; Guillain-Barre syndrome; Headache; Hypoaesthesia; Hyporeflexia; Leukocytosis; Muscular weakness; Pancreatitis; Pleural effusion; Pneumonia	FLU3~EVANS VACCINES~~2~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0194915	12/13/2002	AR	65.0	65		F	11/20/2002	Pt was given flu vaccine 10/30/02 in an outpatient setting. Pt admitted to hospital 11/8/02 with progressive ascending paralysis. Pt diagnosed as having developed Guillain Barr‚ syndrome. Per aclnowledgement letter: I do not have any way of obtaining this information. pt did not receive the vaccine at our institution. 60 Day Follow up States: Pt expired (exact date unknown) Death affiliated to GBS	Y	12/23/2002	Y		Y				N	10/30/2002	11/08/2002	9		UNK	UNK	Methadone		BMH: chronic back pain-on Methadone program; gastric bypass 1992, left knee surgery 1997, volvulus repair 1994			1						1	Guillain-Barre syndrome; Paralysis; Guillain-Barre syndrome; Paralysis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Results in Death	Influenza
0194921	12/13/2002	AZ	24.0	24		F	11/20/2002	Large local reaction. About 100x80mm red and tender (very), injection site hot/warm to touch. Hard lump. Had migraine about 15 min after shot. Lasted for day and a half. No fever.				Y					U	11/18/2002	11/18/2002	0		MIL	MIL	PPD	NONE				1						1	Injection site erythema; Injection site mass; Injection site pain; Injection site reaction; Injection site warmth; Migraine	ANTH~EMERGENT BIOSOLUTIONS~FAV066~4~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~PFIZER\WYETH~4020032~6~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|MEN~SANOFI PASTEUR~UB095AA~1~SC~RA~MENINGOCOCCAL (MENOMUNE)~1	USA	Emergency room visit	Influenza
0194922	12/13/2002	PA	0.5	0	.5	M	12/11/2002	8-10PM on 12/9/02, patient had three episodes of vomiting and was difficult to arouse, was seen in ER. Labs and CT of brain (normal) done 12/10/02. Also rechecked in office 12/10/2002.				Y					Y	12/09/2002	12/09/2002	0	CBC with diff; Electrolytes, CT Brain; EEG pending.	PVT	PVT	NONE	NONE	Piforic stenosis 8/02; dairy intolerance			1						1	Depressed level of consciousness; Laboratory test abnormal; Vomiting	DTAP~SANOFI PASTEUR~C0947AA~3~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U0910AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0657M~1~IM~LL~HEP B (RECOMBIVAX HB)~1|HIBV~SANOFI PASTEUR~UA773AA~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~490532~2~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0194923	12/13/2002	WI	29.0	29		F	11/11/2002	Client reported a rash on back of both legs the evening after vaccine was given. Following day others around patient noticed she had a flushing of her face.									Y	10/15/2002	10/15/2002	0	NONE	PUB	PVT	Prozac	NONE	NONE			1						1	Flushing; Rash	FLU3~PFIZER\WYETH~4020022~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0194924	12/13/2002	ND	22.0	22		F	12/03/2002	Patient called into Family Healthcare 11/26/02 reporting she got a flu shot 11/21/02. On 11/22/02 she woke up with hives on her upper thighs and feeling warm. Patient had no trouble breathing or any other reported symptoms. The hives were gone by 11/23/02 patient stated.									Y	11/21/2002	11/22/2002	1	NONE	UNK	PVT	NONE	NONE	NONE		ND0222	1						1	Feeling hot; Urticaria	FLU3~PFIZER\WYETH~4020027~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0194925	12/13/2002	AR	49.0	49		F	12/07/2002	1/4 nickel size lump grew on top inboard of left wrist. I watched it grow from 5:00 - 5:30 PM.									N	11/21/2002	11/21/2002	0		PUB	PUB						1						1	Injection site mass	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0194926	12/13/2002	UT	53.0	53		F	12/15/2002	Severe nausea, fever-103 degrees, chills, aches									Y	11/19/2002	11/20/2002	1		PUB	PVT				~Pneumo (no brand name)~1~53.00~In Patient		1						1	Chills; Nausea; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0194927	12/13/2002	MN	38.0	48		F	12/09/2002	Pt related pain for approximately 10- 11 days when seen on 12/06/02. Related a deep aching in arm from shoulder to elbow left arm, middle of area especially.				Y					U	11/12/2002	11/24/2002	12	NONE	PUB	OTH	UNK	NONE Known	NONE Known			1						1	Injection site reaction; Pain	FLU3~SANOFI PASTEUR~UO946AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0194928	12/13/2002	MI	53.0	53		F	12/13/2002	11/28 - local redness, swelling @ injection site left deltoid, 11/29 -Swelling  from injection site to sternum, Palpable sub-clavicular node. Tylenol PO taken, 12/03 swelling gone, Area tender									Y	11/27/2002	11/29/2002	2	NONE	PUB	UNK	ASA, Persantine, Calcium, Estrase, Glucosamine		Anti-Thrombin - 3 deficit			1						1	Injection site erythema; Injection site pain; Injection site swelling; Subcutaneous nodule	FLU3~SANOFI PASTEUR~UO950AA~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194929	12/13/2002	CA				U		Very dizzy and had an unusual headache on & off for two days after vaccination									Y	11/06/2002	11/15/2002	9		UNK	UNK	May be allergic to sulfur, PCN	NONE	Heart problems-valve repaired, Atrial fibrillation			1						1	Dizziness; Headache	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0194930	12/13/2002	OH	58.0	58		F		Difficulty breathing the evening of 11/21/02. The next day, developed into wheezing without a  cough. At 1st, thought, it was just nasal drainage, a bad case of it. But after I got into see my doctor, it was asthma + he gave Augmentin script to fill. I haven't had a bout of asthma alone for years. I need to call doctor again and see what else he wants me to be on.				Y					N	11/21/2002	11/21/2002	0	Chest X-ray taken in Dr's office showed asthma	OTH	UNK		NONE	NONE (Was just in for check up 11/?/02 + checked out perfect)			1						1	Asthma; Cough; Dyspnoea; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~ICD9~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0194934	12/13/2002	TN	1.0	1	.1	F	12/09/2002	Red, warm, lesion antimedial aspect left thigh. No temp 1.5cm x 2cm firm, red, non tender lesion				Y					Y	12/03/2002	12/06/2002	3		PVT	OTH	NONE	NONE	UNK			1						1	Rash; Vasodilation procedure	FLU3~SANOFI PASTEUR~0199M~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~1077L~3~~RL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0027M~1~~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~483168~3~~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0199M~1~~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0194938	12/13/2002	CA	72.0	72		F	12/02/2002	Hive localized to left arm - Malaise, dizziness, general flu symptoms - extreme arm and joint pain.									Y	11/06/2002	11/06/2002	0		PVT	PVT		NONE	NONE			1						1	Dizziness; Influenza; Malaise; Myalgia; Urticaria	FLU3~EVANS VACCINES~E30422GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0165M~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0194946	12/13/2002	ME	3.0	3		F	12/09/2002	Mother states off balance, falling backwards. Referred to neurologist for evaluation; failed to keep appointment. Treated by Pediatrician with cough medicines, etc. Otherwise, physical findings unremarkable.				Y					U	11/22/2002	11/29/2002	7		PVT	PUB	Singulair, Claritin		NKDA; Primary communication disorder; Multiple Features consistent with autistic spectrum disorder			1						1	Balance disorder	FLU3~SANOFI PASTEUR~U0928AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1148L~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0194948	12/13/2002	CA	61.0	61		F	12/12/2002	Pt received IM Influenza vaccine 0.5cc in right deltoid at 10:18AM 12/11/02. She woke up this morning at 03:00 with swollen, hives on neck, upper arms and chest walls									Y	12/11/2002	12/12/2002	1		MIL	MIL	HRT, Monopril, Calcium	NONE	NKA, birth defects, Pt has HTN			1						1	Oedema; Urticaria	FLU3~PFIZER\WYETH~4020032~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0194963	12/13/2002	PA	34.0	34		F	11/14/2002	On 11/09/02 developed abdominal and leg cramps, sore throat and L arm pain. Noticed L arm redness, hot to touch. Had limited range of motion of L arm. Symptoms persisted. Began with nausea and vomiting on 11/11/02 and sought treatment at medical center. Hospitalized one day. 11/14/02, L arm remains reddened, warm to touch from mid-upper arm to elbows. Normal range of motion.					Y	1			Y	11/09/2002	11/09/2002	0		PUB	UNK		NONE				1						1	Abdominal pain; Injection site erythema; Injection site pain; Injection site warmth; Joint range of motion decreased; Muscle spasms; Nausea; Pharyngolaryngeal pain; Vomiting	FLU3~SANOFI PASTEUR~U0935CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0996L~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0194965	12/16/2002					M	12/12/2002	A consumer reported that a male adult received Influenza Virus vaccine, Trivalent, Types A & B (1995-1996 formula) vaccine (date of immunization not identified). Subsequent to immunization he experienced paralysis and the patient died in connection with a flu vaccination. The consumer also reported that this individual experienced adverse events following immunization with smallpox in 1950. See Case ID HQ5610404DEC2002. This report was received from a department at a manufacturer. No additional information was available as of the date of this report.	Y								N				UNK	OTH	OTH	UNK	UNK	UNK		HQ5595503DEC2002	1						1	Paralysis	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Results in Death	Influenza
0194966	12/16/2002	NC				M	12/12/2002	A legal complaint was received on 12/03/02 from an attorney alleging that a child received series of Engerix B, Tripedia, Tetramune, Hib-Titer, Tri-Immunol and Flu Shield vaccines from 12/31/92 through 11/12/98 and subsequently experienced toxic neurological effects of mercury poisoning. The legal complaint also stated that the pt experienced mental and intellectual incapacity, developmental incapacity, learning disabilities, and affect disorders and impairments. The pt's symptoms resulted in persistent or significant disability/incapacity. Vaccine info contained in the legal complaint indicated that the child received Engerix B, Tripedia, Tetramune, Hib-Titer, Tri-Immunol, and Flu shield vaccines during the first years of life.								Y	N	11/12/1998			UNK	OTH	OTH	UNK	UNK	UNK		HQ5638006DEC2002	1						1	Drug toxicity; Mental retardation severity unspecified; Neurodevelopmental disorder	FLU3~PFIZER\WYETH~4988235~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0194970	12/16/2002		1.7	1	.2	M	12/11/2002	Follow-up info received 11/20/02 from investigator. The subject experienced asthma exacerbation on 10/13/02 and was subsequently hospitalized on 10/14/02. He was treated with Ventolin, Atrovent, paracetamol and prednisolone. He recovered and was discharged on 10/16/02 with Flixotide inhalers for preventative therapy. The investigator, who remains blinded, has changed his assessment to probably not related to the study vaccine. The original assessments made by the medical monitor remain unchanged. An investigator reported that a 20 month old male received a 2nd dose of influenza virus vaccine on 3/26/02, when he was 14 months old, as part of the study entitled: A Randomized, Placebo-Controlled, Trial To Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A & B, Live, Cold Adapted (FluMist) and MMR II, and Varivax Vaccines Administered Concurrently To Healthy Children. On 2/4/02, the subject received a 1st dose of FluMist, along with Varivax and MMRII. On 5/9/02, the subject also received Placebo. Medical history includes tow previous hospitalizations on 6/20/02 and 7/1/02, for asthma exacerbation and an emergency department visit on 8/21/02 for asthma. On 10/1/02, the pt was re-admitted for asthma exacerbation. On 10/3/02, he was discharged following a complete recovery. The investigator (who remains blinded) assessed the event as severe and probably not related to the study vaccine and definitely not related to MMR II and Varivax. The medical monitor considers the event probably not related to the study vaccine due to the lack of a temporal relationship between vaccination and event onset.					Y				Y	03/26/2002	10/01/2002	189	NONE	UNK	UNK	Placebo for influenza virus vaccine		Asthma		HQ5396719NOV2002	1						1	Condition aggravated	FLU3~PFIZER\WYETH~~2~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation	Influenza
0194982	12/16/2002	NY	50.0	50		M	12/10/2002	Dx transverse meylitis 12/7/02. Sudden onset. Etiology not known. Received two flu vaccines 10/08/2002, 11/07/2002. 60 day follow up states pt has not recovered. Transverse myelitis- no change in symptoms. The annual follow up received on 1/13/04 states persistent paralysis. Discharge summary states deep vein thrombosis. msv Medical records state anemia, urinary retention, urinary infection. msv					Y				N	11/07/2002	12/07/2002	30	CT scan/MRI spine/LP Medical records state decreased plateletts, anemia, hyperglycemia. msv	PVT	PVT		NONE	Mental Retardation			1						1	Anaemia; Deep vein thrombosis; Hyperglycaemia; Myelitis transverse; Paralysis; Thrombocytopenia; Urinary retention; Urinary tract infection	FLU3~EVANS VACCINES~E32072GA~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0194987	12/16/2002	IN	55.0	55		F	11/26/2002	Early am 11/15/02 awoke to terrible itching on hands. Hives were prominent. Before 11:00am, hands were very swollen, 11/15/02 Went to doctor, Got medicine for itching hives. Sunday evening 11/11/1987 went to ER-Excessive pain in shoulders and wrists, Could not move arms, Pain medication given, Checked by physician on Wed 11/20, still signs of swelling, From that time to present have had swelling and pain in joints of both hands, Right  hand has numbness.				Y					U	11/14/2002	11/15/2002	1	going for allergy test	OTH	PVT	Zestorectic- High Blood Pressure, Premarin, Zocor, Allegra, Vioxx, Had been on Amoxicillin for tooth infection					1						1	Arthralgia; Hypersensitivity; Hypokinesia; Oedema peripheral; Pain; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U088@AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0194988	12/16/2002	WI	59.0	59		F	11/26/2002	11/18/02 Employee received flu shot and had an adverse reaction 1 hour later. She returned to the flu clinic complained of swelling, intense aching of left arm where flu shot was administered. Employee sent to occupational health services and seen by RN who sent employee to ER for further treatment. No SOB or respiratory problems were present. Area was ? free of redness or firmness. Sent home after treated without further problems.				Y					Y	11/18/2002	11/18/2002	0	NONE	PVT	PVT		NONE	Allergy to bee and wasp stings			1						1	Myalgia; Oedema	FLU3~EVANS VACCINES~E31902HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0194989	12/16/2002	MO	39.0	38		F	12/09/2002	Less than 10 minutes, patient report itching and burning at injection site. Left deltoid red, warm and swollen approximately 40-50mm. No SOB or hives. Ice applied. One hour later patient reports mild SOB and scratchy throat. Antihistamine given. No hives.									Y	12/06/2002	12/06/2002	0		OTH	PVT	Efexor 75mg, Xanax 1mg	NONE	NONE			1						1	Dyspnoea; Injection site hypersensitivity; Oedema; Pruritus	FLU3~EVANS VACCINES~ES7182KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0194991	12/16/2002	CA	47.0	47		F	12/07/2002	Allergy to eggs, severe shock, stuffiness ? shot. Benadryl				Y					Y	11/14/2002	11/14/2002	0		UNK	UNK						1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0194992	12/16/2002	CA		1	.1	M	12/08/2002	Patient visiting from Sacramento area. Seven days after receiving MMR(11/15/02) Had 2.5 hours of high pitched screaming inconsolable. Next day fine. Normal									Y	11/15/2002	11/22/2002	7		PVT	PVT	Amoxicillin	Otitis Media, URI	NONE			1						1	Screaming	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~1~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~1~~~VARICELLA (NO BRAND NAME)~1	USA		Influenza
0194996	12/16/2002	IA	45.0	45		F	12/13/2002	Pressure behind right ear radiating alongside of right neck area, pressure of right ear, facial mask of right side.				Y					N	12/02/2002	12/03/2002	1		PUB	OTH	Premarin	NONE	NONE			1						1	Ear pain	FLU3~EVANS VACCINES~E37182KA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0195043	12/16/2002	WA	24.0	24		F	12/16/2002	Patient flushed, dizzy - left ear flushed.  Patient felt very hot, then chills.									Y	10/25/2002	10/25/2002	0		UNK	UNK	Orthocyclin - patient takes on own	None	None known			1						1	Chills; Dizziness; Feeling hot; Flushing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0195111	12/16/2002	FL	6.0	6		M	12/16/2002	Flu Vaccine given, extreme soarness at site and swelling in armpit lasting 9 days									Y	10/01/2002	10/02/2002	1		PVT	UNK	allegra, sodium flouride, multi-vitamin		allergy patient, asthmatic			1						1	Injection site pain; Oedema	FLUX~UNKNOWN MANUFACTURER~?~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0195042	12/17/2002	NC	9.0	9		F	12/06/2002	Within 2-3 days of flu shot, developed symptoms of diabetic which progressed over 3 weeks to diabetic ketoacidosis.			Y	Y	Y			Y	Y	10/29/2002	10/31/2002	2	Hyperglycemia/ketones/acidosis	PVT	PVT		NONE	NONE			1						1	Acidosis; Hyperglycaemia; Ketoacidosis	FLU3~SANOFI PASTEUR~U0880AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0195047	12/17/2002	CA	47.0	47		F	12/02/2002	After injection, left arm very sore. 8:30PM, stomach upset; took Pepcid AC. 11:30PM, woke up fever, severe chills, shaking violently. Tried to call for help but no one heard her. 300AM woke up; fever broke, was soaking wet, stopped shaking. The next day (Thursday) very weak, dehydrated, headache, nausea. Went to doctor. BP 60/40; given Phenergan and Tordel. had to drink Gatoraide; was disoriented. Sent home on clear liquids. Saturday 11/23/02, started feeling better.				Y					Y	11/20/2002	11/20/2002	0	NONE	PUB	PUB	Valium; Estrogen; Pepcid AC; Vicodin compounded with ginger		Hepatitis C, Liver Fibrosis, Rheumatoid Arthritis, Fibromyalgia, Sinus Problems		CA020098	1						1	Asthenia; Blood pressure decreased; Chills; Dehydration; Headache; Hyperhidrosis; Nausea; Pyrexia; Stomach discomfort; Tremor	FLU3~SANOFI PASTEUR~U0920AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0195048	12/17/2002	CO		5		F	12/12/2002	Patient seen 12/4/02 for routine physical. Office administered DTaP (right thigh IM) and flu vaccine (left thigh, IM). Patient presented to office 12/6/02 with redness, swelling and heat at site on right thigh at DTaP site.									Y	12/04/2002	12/06/2002	2	Strept throat culture performed on 12/6/02. Results positive for Strept; not group A.	PVT	UNK		Vaginitis	NONE			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Viral infection	DTAP~SANOFI PASTEUR~C0947AA~5~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U0940AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195049	12/17/2002	IL	58.0	48		F	11/25/2002	Patient complained of 4 inch diameter of redness, edema encircling entire upper arm and it includes axilla, weakness, and states, couldn't move arm for 2 days. Patient currently taking Ibuprofen and is seeing some slight daily improvements.									Y	11/22/2002	11/23/2002	1	NONE	PUB	PUB	Ultracet; Multi-vitamin	NONE	NONE		IL02066	1						1	Asthenia; Injection site erythema; Injection site oedema; Joint range of motion decreased	FLU3~SANOFI PASTEUR~U0946AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0111M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0195050	12/17/2002	IL	58.0	58		F	12/09/2002	Cellulitic type reaction in right arm 6cm proximal to 8cm distal to injection site. Neatly circumferential.				Y					U	12/05/2002	12/05/2002	0		PVT	UNK	NONE	NONE	NONE			1						1	Cellulitis; Injection site reaction	FLUX~UNKNOWN MANUFACTURER~1026M~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~E6592KA~1~IM~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0195051	12/17/2002	MO	22.0	22		F	11/19/2002	11/16/02 Complained of edema and redness at site; slight yellow discharge from site where vaccine given; describes as if pimple burst. Applied warm compresses. Notified physician and seen on 11/18/02. Was told area was slightly infected. No antibiotics given. Rx warm compresses and observe.									Y	11/15/2002	11/16/2002	1		PUB	PUB	OBC, Claritin; Celexa	NONE	Allergy to oranges		MO2002040	1						1	Injection site erythema; Injection site oedema	FLU3~EVANS VACCINES~E37202LA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0195052	12/17/2002	AZ	32.0	32		M	12/17/2002	Developed chills, nausea, severe body ache day after receiving Pneumovax, flu and Td booster. Vomited once. Improving the following day. Felt febrile but did not check temperature. No further vomiting. Tylenol i-ii q 6h. Patient did not got o work on 12/11/02.									Y	12/10/2002	12/10/2002	0	NONE	PVT	PVT		Type I Diabetes - controlled	NKDA, Type I Diabetes (controlled)			1						1	Chills; Nausea; Pain; Vomiting	FLU3~PFIZER\WYETH~4420002~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0445~UNK~IM~~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U0816AA~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0195053	12/17/2002	SC	37.0	37		F	10/28/2002	On Saturday evening, began feeling achy, had chills and sweats, felt feverish. Did not take temperature. Right arm was sore soon after injection. However on Saturday, right arm at injection site was red, swollen and hot to the touch.									Y	10/25/2002	10/26/2002	1		PUB	PUB					SC0257	1						1	Chills; Feeling hot; Hyperhidrosis; Injection site erythema; Injection site swelling; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U0926CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1353L~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0195054	12/17/2002	IL	76.0	76		F	12/03/2002	Noted redness, itching at site of Pneumovax injection after 1 week. Seen by nurse practitioner in office. Diagnosed local allergic reaction. Prescribed Medrol dose pack and to pick up Cortaid. Erythema had increased the following day. Zyrtec added.									Y	11/18/2002	11/26/2002	8		PVT	PVT	Aciphex, Celebrex	NONE	NKDA			1						1	Erythema; Injection site erythema; Injection site hypersensitivity; Injection site reaction; Pruritus	FLU3~PFIZER\WYETH~4020017~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1160L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0195055	12/17/2002	MD	68.0	68		F	12/10/2002	Complained of increased pain in left arm with muscle and nerve involvement. Area ecchymotic, patient a nurse (increased upset) state I'm giving at wrong area to PMD if no better.									Y	11/22/2002	11/23/2002	1		PUB	PVT	NONE	NONE	NONE			1						1	Ecchymosis; Pain	FLU3~PFIZER\WYETH~U020022~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0195056	12/17/2002	CA	51.0	51		M	12/09/2002	Evening after flu vaccine bump on arm itchy; faded away, then rash on chest pinhead size pustules, then now around neck. No fever, no swelling, redness arm, no malaise.									N	11/26/2002	11/26/2002	0		OTH	OTH	Sustiva, Epivir, Videx, Lotensin	HIV				1						1	Rash maculo-papular	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195057	12/17/2002	AR		70		F	10/30/2002	Complained of joint aches and swelling. Worsened arthritis sx.									Y	10/15/2002				PVT	OTH	Cozaar, Glucophage, ?, Glucotrol, Zoloft, levothyroxine, hydroxyzine, Detrol, ambein, aricept, Darvocet-N 100	NONE	NIDDM, depression, arthritis			1						1	Arthralgia; Oedema	FLU3~SANOFI PASTEUR~U0904CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195105	12/17/2002	WA	37.0	37		F	12/04/2002	2 weeks, persistent, Left deltoid, pain + painful, range of motion since the vaccine on 11/14/02.									N	11/04/2002	11/15/2002	11		PVT	PVT	Birth Control Pills		History of sarcoidsis -  1990, Not active now			1						1	Hypokinesia; Injection site pain; Pain	FLU3~SANOFI PASTEUR~UO951AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195106	12/17/2002	AZ	44.0	44		F	05/06/1958	Rapid HR 92, in 4-6 hours after injection. That nite or the next nite, dizziness with turning side to,  Head fells fuzzy, Worse after yoga (last nite-not better today.									N	12/02/2002	12/02/2002	0		PVT	OTH	NONE	NONE	Augmentin, betadine, tinnutis, took ABx X 9 yrs			1						1	Dizziness; Feeling abnormal; Heart rate increased	FLU3~SANOFI PASTEUR~UO921CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195115	12/18/2002	KY	47.0	47		F	12/16/2002	A pharmacist reported that a 47 year old female received Flu Shield on 11/6/02. Medical history includes a mental handicap. Subsequent to immunization, the pt experienced neurological symptoms. She was described as less responsive with loss of ability to move her lower extremities. The pt was taken to an acute care facility (where the pharmacist is employed) and then transferred to a medical center. Tests (not identified) were performed with negative results. As of the last report received from the hospital, the pt was unable to move her legs.  A 15-day follow up report received 02/19/2003 adds: Medical history includes 'mild' mental retardation, epilepsy and obsessive compulsive disorder. Concomitant medication included fluvoxamine, valproate semisodium (Depakote), acetaminophen (Tylenol), vitamin C (Centrum Vitamin C), multivitamins with minerals, and Falvit (calcium/vitamins). On 11/6/2002, the pt was brought to the ER. A day or two prior, she was noted to be increasingly lethargic, with a rapid heartrate and a distinct change in her mental status. On 11/8/2002, she was admitted to the hospital, started on intravenous fluids and maintained on 'Fluxomine'. Initial Depakote levels were 139. She was diagnosed with Depakote toxicity and Depakote was withheld. Depakote levels returned to normal though the pt's mental status remained unchanged. A neurology consultation was obtained and she was treated with Atenolol for a persistent increased heart rate. The pt developed a fever. A diagnosis of encephalitis was suspected. A lumbar puncture was performed (unremarkable) and acyclovir sodium (Acyclovir) was started. A central line was placed to facilitate intravenous access of medications. The pt's condition remained essentially unchanged, with persistent restlessness, confusion, change in mental status, intermittent tachycardia, and intermittent fever. No definite neurological diagnosis was made. Discharge medications included ceftazidime (Fortaz), hydroxyzine hydrochloride (Atarax), lorazepam (Ativan), valproate semisodium (Depakote) and atenolol (Tanormin). On 11/26/2002, the pt was transferred to a University Medical Center for further neurological evaluation. At the University Medical Center she was diagnosed with fever of unknown origin, possible immunodeficiency, anemia and hypertension. Laboratory tests and procedures include the following: On 12/2/2002, a Computerized Tomogram of chest, abdomen and pelvis revealed nodule opacity in the apex of the right lung, less than 1 mm; noncancerous appearing right middle lobe nodule, borderline, pretracheal node, simple left renal cyst. A chest X-ray also noted nodular density. On 12/28/2002, blood culture results revealed 'MRSA grew and was thought to be nosocomial'. She was treated with vancomycin hydrochloride (Vancomycin) for 14 days. A Nuclear Medicine Bone Scan was normal though 'slight increase turnover in her right shoulder'. CD4 lymphocytes were 173 (abnormal). A CDS lymphocytes were 108 and CD3 were 320. A blood Immunoglobulin G was 1932 (slightly high). A Immunodeficiency Cell Marker Study resulted in abnormal findings as follows: 60% mature T cells, 12% natural killer cells, 22% mature B cells, 22% mixture of mature and immature B cells. D cell population had a CD4-CD8 ratio or 4:1. CD4 helper cells consist of 60% hemoxy cells and 40% naive cells. CD8 cells were classified according to their CD28 markers. The B cell population was classified according to HR8-DR and the CD19 markers 8-9% of the B cells had surface immunoglobulins and was noted to have decreased expression of IgM and IgD expression. This was variable. It could possibly indicate immunodeficiency such as common variable hypogammaglobulinemia, although this is not clear. Additional tests were performed with negative findings (see source document for details). The pt's fever was noted to be a 'mystery even after every test available to us was done'. She was treated with vancomycin hydrochloride, co-trimoxazole (Bactrin) and gancioclovir sodium with no change in temperature. She was treated with suppression therapy with acetaminophen (Tylenol) and then naproxen sodium. She improved though continued to have 'minor' fevers. The pt's mental status never changed. She was never alert or oriented. She never spoke in a meaningful way or responded in a meaningful way to any verbal commands or noxious stimuli. The pt was noted to be anemic (iatrogenic anemia) on admission as a result of continuous blood draws for a month and a half. The blood draws were reduced; she stabilized and improved. During the second hospitalization, the pt developed hypertension. She was treated with metoprolol fumarate and was controlled well. The CD4 and CD8 counts were normal on January 22, 2003 and Bactrin for PCP prophylaxis was discontinued. The pt received a PEG tube for tube feeds, on January 23, 2003 without any complications. She was discharged on 01/28/2003 in stable condition, to a long term care facility. On follow-up, a physician reported 'we have no hard evidence to suspect that the immunization had anything to do with her rather bizarre neurological problem'.				Y	Y				U	11/06/2002	11/08/2002	2	negative results: Antinuclear antibody; aspiration bone marrow; blood culture; blood immunoglobulin A, G and M, CD4, CD8, Complement factor; Computerized tomogram; Cytomegalovirus serology; electrocephalogram; HIV test; Haemoglobin; Lumbar puncture; nuclear magnetic resonance imaging; polymerase chain reaction; Scan; bone scan; syphilis test; ultrasound scan; X-ray chest.	OTH	OTH	Centrum vitamin C, Depakote, Falvit, Fluvoxamine, multivitamins with minerals	UNK	Mental retardation severity unspecified		HQ5674409DEC2002	1						1	Heart rate increased; Hypokinesia; Lethargy; Neurological symptom	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0195117	12/18/2002	AR	85.0	85		F	12/16/2002	A consumer reported that her 85 year old mother received Flu Shield on 11/8/02. Concomitant medication included triamterene/hydrochlorothiazide (manuf unk), Inderal, calcium and vitamin E. Medical history includes rheumatoid arthritis, hypertension, heart problems and broken hip 4 years ago. On the evening of 11/9/02, her mother did not sleep well, had dreams all night and didn't look right in her eyes. On 11/12/02 she seemed confused and has been confused since. On 11/22/02, a MRI of the head was performed with negative results. The pt was living independently prior to the immunization but is now in senior facility. This case was serious since the event of confusion was considered medically important in this case (OMIC).				Y					U	11/08/2002	11/12/2002	4	Nuclear magnetic resonance imaging 11/22/02 MRI of the head, results normal	PUB	OTH	Inderal	NONE	Cardiac disorder NOS; Hypertension; Rheumatoid arthritis; Hip fracture		HQ5709210DEC2002	1						1	Confusional state; Sleep disorder	FLU3~PFIZER\WYETH~402008~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0195123	12/18/2002	NC	82.0	82		F	12/17/2002	Joints in arm became really painful. Couldn't move arm. Still has soreness where shot was given. *Follow-up report on 3/3/03: Still have pain in arm, especially where punctuated on the upper arm. Barely recovered. Still have some pain in shoulder. Same as when I received the shot last November. Received a flu shot now at doctor's office and have had no pain whatsoever.								Y	Y	11/14/2002	11/14/2002	0		UNK	UNK						1						1	Arthralgia; Injection site pain; Joint range of motion decreased; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0195126	12/18/2002	OR	61.0	61		F	12/10/2002	One hour minor itching on hands. 12 hrs some hives on body. 24 hrs hives all over, swollen lip, tongue and eye lids. Emergency room. Found no pulse. Anaphylaxic shock. 2 days in ICU, 3rd day-reoccurrence of reaction-ER.   60 day follow up states pt has recovered. It took a good 2-3 months to fully recover. An annual follow up report received 01/14/2004 adds: (from pt): Thank you for your recent inquiry into my health - and since you asked - I would like to report some very uncommon medical problems I've experienced this last year. Prior to my adverse reaction to the flu shot I have been healthy as a horse and never hospitalized. In March 2003 I was diagnosed with an abscess on my liver - cause unknown. It was drained and all was well. Then in June I had a twisted bowel or something - they didn't know exactly what it was, but that was drained too. I was just released from the hospital for premature atrial contractions...further testing to follow because the cause is unknown. I am reporting this because the cause of all my conditions seem to be unknown and curious if there could be any connection to the flu shot complications...my husband thinks I've taken out a time-share at the hospital...Thank you for any light you can shed on this.			Y	Y	Y	2			N	11/15/2002	11/16/2002	1		PUB	PVT	Levoxyl, Tenormin	NONE				1						1	Nonspecific reaction	FLU3~EVANS VACCINES~E35462HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0195127	12/18/2002	VA	6.0	6		M	11/07/2002	Within one hour of administration began with shortness of breath. Progressed to swelling of eyelids, lips. Due to history of asthma, admitted to ICU for monitoring. Given steroids and nebulizer treatments.				Y	Y				Y	11/06/2002			Pulse Ox decreased to 89% after administration	MIL	MIL		URI	Asthma			1						1	Dyspnoea; Eyelid oedema; Face oedema	FLU3~SANOFI PASTEUR~U0983AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0195128	12/18/2002	FL	66.0	66		F	11/30/2002	Injection at 6pm 11/23/02. Next morning noticed tongue black in color and teeth stained but teeth brushed clean. Tongue could not be cleaned. no pain or swelling. By 11pm tongue back to normal.									Y	11/23/2002	11/23/2002	0	NONE	OTH	UNK	Lipitor	NONE				1						1	Tongue discolouration	FLU3~PFIZER\WYETH~4020002~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~09994L~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0195129	12/18/2002	WA	6.0	8		F	12/10/2002	Periorbital swelling (bilateral) Hives. Diphenydramine Hcl 25mg given in office; rx given for home administration. Assessed by physician.				Y					Y	12/10/2002	12/10/2002	0		PUB	UNK		Eczema		hives~Influenza (Seasonal) (no brand name)~~4.00~In Patient		1						1	Oedema; Urticaria	FLU3~SANOFI PASTEUR~U0909AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0195130	12/18/2002	FL	79.0	79		M	11/05/2002	10/30/02 woke up at 6 AM with thick tongue. By 12 noon 10/30/02, symptom of thick tongue was gone. Did not see MD or take any treatment. Had same symptoms previously after an insect bite, but never from flu shot.									Y	10/29/2002	10/30/2002	1		PUB	PUB	NONE	NONE				1						1	Tongue disorder	FLU3~SANOFI PASTEUR~U0909AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195131	12/18/2002	MI	52.0	52		F		Immediately became syncopal at time of injection. No c/o SOB, itching only state faint feeling. Became diaphoretic, nauseated, BP 90/0, pale. Amonia cap helped relieved symp. Layed client flat BP up 145/84, cool cloth applied, rested, BP 126/78 after 10 minutes.				Y					Y	11/21/2002	11/21/2002	0	NONE	PUB	PUB		NONE	UNK		MI2002092	1						1	Hyperhidrosis; Nausea; Syncope	FLU3~PFIZER\WYETH~4020023~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0195132	12/18/2002	MI		56		F	11/26/2002	Arm got swollen and very painful with range of motion.									U	11/08/2002	11/09/2002	1		PUB	UNK					MI2002091	1						1	Hypokinesia; Oedema	FLU3~PFIZER\WYETH~4020021~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0195133	12/18/2002	MI	4.0	4		M	12/12/2002	Patient broke out with hives.									Y	12/03/2002	12/04/2002	1		OTH	UNK						1						1	Urticaria	FLU3~SANOFI PASTEUR~U0941AA~UNK~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195134	12/18/2002	IN	76.0	76		F	12/07/2002	All joints in fingers, wrists, elbows, shoulders, neck; shot given in left shoulder hurt bad, blood ran down arm. Very exhausted rest of day. Unbelievable pain on arising. Went to internist regular doctor couldn't explain. Been 7 weeks and still suffering, never had this kind of pain before shot.									N	11/19/2002	11/20/2002	1		PUB	UNK	Prednasone, Prilosec, Zoloft	NONE	Fibromyalgia, Polymyalgia			1						1	Asthenia; Pain	FLU3~EVANS VACCINES~E32972GA~2~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0195138	12/18/2002	MA	56.0	56		F	12/12/2002	Right arm warm to touch, some swelling, painful to move, pain goes from shoulder joint down to fingers.				Y					U	12/11/2002	12/11/2002	0		PVT	OTH		NONE				1						1	Oedema; Pain; Vasodilation procedure	FLU3~SANOFI PASTEUR~U0879AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0358M~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0195139	12/18/2002	WA		30		F	11/13/2002	Reddened, swollen and hot to the touch. With rash look around the edge for 1 next day and better today.									N	11/07/2002				OTH	UNK		NONE				1						1	Oedema; Rash; Vasodilation procedure	FLU3~SANOFI PASTEUR~U0968AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195140	12/18/2002	VA	1.0	0	1	M	11/29/2002	11/18 onset of fever (103 or greater) 8 hours after vaccination, diarrhea, and some vomiting for 72 hours, achiness, crying, change in temperament, fussier and irritable, night waking. Red bump at injection site on right leg.				Y					U	11/18/2002	11/18/2002	0		PVT	UNK				~Measles + Mumps + Rubella (no brand name)~~1.00~In Sibling		1						1	Agitation; Diarrhoea; Injection site mass; Myalgia; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U0939AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0632M~1~~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0599M~1~~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0195141	12/18/2002	MI	39.0	39		F	12/11/2002	Mon 12/09/02 -Right increased arm, sore & achy, Tues 12/10/02 right increased arm, sore,red, warm and swollen, white patches (hives) Called dr, Benadryl taken, Arm red, rashy on 12/11/02 has dr appt 12/11/02				Y					Y	12/09/2002	12/09/2002	0		PUB	UNK		NONE	PCN/ASA			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pain; Rash; Urticaria	FLU3~SANOFI PASTEUR~UO881AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0676M~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0195142	12/18/2002	PA	9.0	9		M	12/12/2002	Mother called 12/12/02 stating child had right deltoid (site of flu shot) swollen  1.5 in to 2 in wheal, red + raised. Area raised-size small apple. Mother gave Benadryl at hs 12/11/02 applied cool compresses to area, giving Tylenol prn for pain.									U	12/10/2002	12/11/2002	1	NONE	PVT	PVT	Started on Ceftin 250mg BID 12/10/2002	LOM +sinussitis-symptoms started week ago				1						1	Injection site erythema; Injection site swelling; Urticaria	FLU3~SANOFI PASTEUR~UO924EA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195172	12/18/2002		74.0			F		A report was received from a regulatory authority on 12/6/02 concerning a 74 year old female vaccinee who experienced thrombocytopenic purpura which lead to hospitalization, 21 days after receiving the Fluvirine vaccine on 10/9/02.  The vaccinee had a history of hypertension, hypertrophic cardiomyopathy, hypercholesterolemia and asthma. The vaccinee was receiving spironelactose, verapamil, formeterol fumerate, pravastatin, beclometasone and naftidrofuryl oxalate concomitantly. During October 2002, the vaccinee took arthrotec 2 or 3 times for arthritic knee pain and on 10/16/02, fluoxetine was commenced for depression. On 10/30/02, the vaccinee experienced general purpuric lesions on all 4 limbs, complicated with oral hemorrhagic lesions and epistaxis. The vaccinee was hospitalized on 11/1/02. The vaccinee had a platelet count of 2000/mm^3 which led to the diagnosis of thrombocytopenic purpura. All drugs were discontinued. Treatment with IV corticotherapy and normal human immunoglobulins was given for 5 days. Platelets were transfused. A myelogram seemed to show a peripheric thrombocytopenia (rich spina; no malignant cells; normal and heavy megakaryocytes). On 11/6/02, the IV corticotherapy was replaced by prednisone. The purpura decreased and the platelet count increased (64,000/mm^3 on 11/6/02; 212,000 mm^3 on 11/7/02. On 11/8/02 verapamil and formoterol fumarate were restarted. On 11/15/02 the platelets were 616,000/mm^3. The anti-nuclear antibody, HIV, Hepatitis B and C tests were all negative and the direct Coomb's tests was positive. The vaccinee had a positive serology for Parvovirus B19. The vaccinee was considered to have recovered on 11/15/02. The reporter has assessed the relationship of the vaccine to the event as possible.					Y				Y	10/09/2002	10/30/2002	21	Antinuclear antibody negative; Direct Coombs Test positive; Hepatitis B serology negative; Hepatitis C serology negative; HIV serology negative; Myelogram - peripheric thrombocytopenia (rich spinal; no malignant cells, normal and heavy megakaryocytes; Parvovirus B19 positive; Platelets 2000, 64,000, 212,000, 616,000	UNK	UNK	Spironone Microfine, Artotec, Fluoxetine, Isoptine, Foradil, Vasten, Nexxair, Di-actane		Hypertension, hypertrophic cardiomyopathy, hypercholesterolemia, asthma		PJP200200834	1						1	Arthralgia; Laboratory test abnormal; Platelet count increased; Skin ulcer; Thrombocytopenia; Thrombocytopenic purpura	FLU3~EVANS VACCINES~~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0194206	12/19/2002	MI	49.0	48		F	12/12/2002	Shot was given at the top of the left shoulder; painful when administered. Soreness began within minutes, very painful, went to doctor 3 weeks later and told it was Tendonitis. Prescribed Celebrex and ice pack.				Y						10/24/2002	10/24/2002	0		PUB	OTH	NONE	NONE	NONE			1						2	Back pain; Injection site pain; Injection site pain; Shoulder pain; Tendonitis	UNK~UNKNOWN MANUFACTURER~U0928AA~UNK~~~VACCINE NOT SPECIFIED (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U0910AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0195177	12/19/2002	CA	49.0	48		M	12/17/2002	Follow-up info received on 12/9/02 provided pt details, dates of vaccination and event onset, recovery status, and treatment. A medical assistant reported that a 49 year old received an injection of Flu Shield on 10/15/02. Within two minutes of immunization, clamminess and lightheadedness. An electrocardiogram was normal. The pt's blood pressure was 152/95mm Hg and his pulse ox was 98% on room air. He was treated with Benadryl, oxygen, Proventil, and unspecified steroids. The pt was seen in an ER where he was treated with methylprednisolone. The pt also developed a 3 inch by 1 inch area of edema at the injection site. He recovered. Dyspnea, tongue edema, and throat tightness were considered medically important (OMIC) in this case. As a result of follow up info, this report has been reclassified as serious, unlabeled. This is one of two reports concerning pts from this facility who experienced an adverse event following receipt of Flu Shield. See related case HQ4782423OCT2002.				Y					Y	10/15/2002	10/15/2002	0	Electrocardiogram: normal	PVT	OTH	NONE	NONE	Immunodeficiency NOS; Reiter's Syndrome		HQ4773523OCT2002	1						1	Cold sweat; Dizziness; Dyspnoea; Injection site oedema; Throat tightness; Tongue oedema	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0195178	12/19/2002	TX	44.0	44		F	12/17/2002	A healthcare professional reported that a 44 year old female received an injection of Flu Shield in November 2002. Subsequently, she developed arthritis, joint pain, arthralgia, and hives. On 11/29/02, she was seen by a physician and a diagnosis of serum sickness was made. Treatment with Celebrex, Vicodin, and Allegra was started. On 12/2/02, she was seen by another physician who confirmed the diagnosis of serum sickness. Celebrex was discontinued and Zantac was added to her therapeutic regimen. No further info was available at the date of this report. This event is considered medically important (OMIC). Additional info was received on 1/13/03, from a physician provided revised symptoms, additional treatment medication, and event outcome. A healthcare professional reported that a 44 year old female received an injection of Flu-shield (2002-2003 Formula) in November 2002. Twenty-four hours post vaccination, she developed right eye swelling (almost swelled shut), which progressed to hives, chills, cough, and joint pain. On 11/29/02, she was seen by a physician and a diagnosis of serum sickness was made. Treatment with Celebrex,, Vicodin, and Allegra was started.On 12/2/02, she was seen by another physician who confirmed the diagnosis of serum sickness. Celebre was discontinued and Zantac was added to her therapeutic regimen. Her symptoms resolved gradually after a course of prednisone. She recovered. This event was considered medically important (OMIC).									Y	11/01/2002	11/29/2002	28	UNK	OTH	OTH	UNK	UNK	UNK		HQ5676409DEC2002	1						1	Arthralgia; Arthritis; Eye oedema; Serum sickness; Urticaria	FLU3~PFIZER\WYETH~4020003~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0195180	12/19/2002	TX	49.0	49		M	12/13/2002	Had appointment at 09:45 on 12/3/02 at clinic. Was given 2 vaccines at approximately 10:30; same day - pneumococcal and influenza. By 13:00, I was running 103 fever with joint and body pain and severe headaches. I called clinic that gave shots on 12/4/02 to talk to nurse about problems and she said come in on 12/5/02 about 13:00 and she would try to work me in. I've been through this before so I didn't go, since also I was on crutches and had so much swelling and soreness on right arm below arm pit where they gave both shots in some place I could not use crutch. By late Thursday night, 12/5/02, I started getting rash from right arm, arm pit, across entire back to waist, around sides and started to go to chest. The lowest I got my fever was 102.8 taking Tylenol every 4 hours, and my lower back, kidneys started hurting real bad and hard to urinate, and or burning. Early 12/6/02 Friday morning, I had bad sweats to where my night clothes were sopping wet and then my fever went down to 99.5, the lowest it had been since I had shots. I called the ask a nurse at hospital where I had got shots from  their clinic that morning and the RN said I need to be seen. So I was there by 10:00AM on 12/6/02 Friday after being seen at the hospital clinic, I was sent to ER, after being seen by their RN and waiting longer I was sent back to another part of the ER to see a doctor. When the nurse saw my rash and other things and said I needed to be admitted to ER about 15:30, they put IV's in my arm, took blood, gave shots in IV and left arm, EKG, X-Rays. By about 22:00, my fever was down and headache better and they let me go saying I had the flu. That is BS; they just didn't want to file paper work as required by law. My BP was 175/96 at first clinic and temperature was 99.5; this was never either one again all night long. By 03:00 Saturday, 12/7/02, my fever was up to 99.5 again and my rash rash was burning, itching and hurting. This was until Sunday afternoon. My fever is down, my kidney's are finally not hurting but till this day, I still have leftovers of the rash though its not hurting and getting better. I know now why you show a low percent of problems these affects are never reported by doctors.				Y					U	12/03/2002	12/03/2002	0		PUB	UNK	Erythromycin					1						1	Arthralgia; Back pain; Dysuria; Headache; Hyperhidrosis; Pain; Pruritus; Pyrexia; Rash; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0195181	12/19/2002	MN	55.0	55		F	12/13/1947	Within approximately 48 hours, started feeling achy. Joints started hurting; first feet and ankles and progressed to knees, lower back, shoulders, wrists, and fingers. Headache front portion of head; lasted about 1 month. Advil helped but did not take away full joint/body aches.									U	11/05/2002	11/07/2002	2	NONE	OTH	OTH	Advil	NONE	Sleep Apnea			1						1	Arthralgia; Back pain; Headache; Pain; Shoulder pain	FLU3~EVANS VACCINES~E37182KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0195182	12/19/2002	MD	46.0	46		F	12/16/2002	12/9/02 Flu shot. 12/11/02 Developed scratchy throat. 12/12/02 Developed hoarseness, runny nose, sneezing and slight cough. 12/14/02 Developed hives on left side of face. No vital signs taken. Client did not see MD nor report to RN.									Y	12/09/2002	12/11/2002	2	NONE	PUB	PUB	NONE	NONE	Fibromyalgia			1						1	Cough; Dysphonia; Pharyngolaryngeal pain; Rhinorrhoea; Sneezing; Urticaria	FLU3~SANOFI PASTEUR~U0958AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195184	12/19/2002	AR	42.0	42		F		Rash over entire body.									Y	11/13/2002	11/21/2002	8	NONE	PUB	PVT	PPD					1						1	Rash	FLU3~EVANS VACCINES~E33162GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0195201	12/19/2002	NY	44.0			F		A report was received from a vaccinee's family member on 12/10/02 concerning a 44 year old female vaccinee who experienced transverse myelitis 10 days after receiving Fluvirin on approximately 11/19/02. The vaccinee's past medical history was reported to be unremarkable and no concomitant medication was reported. The vaccinee had never previously received a flu vaccine. On 11/29/02 the vaccinee was hospitalized secondary to loss of the use of both legs, paralysis and numbness below the waist. A neurologist diagnosed the vaccinee with transverse myelitis. It was reported that the vaccinee had good bilateral reflexes and that her muscles were fine, however, the vaccinee could not feel anything in both legs below the waist. It was reported that the vaccinee was being treated by a neurologist and was unresponsive currently to unspecified therapy.					Y			Y		11/19/2002	11/29/2002	10		UNK	UNK					PJP200200843	1						1	Coma; Hypoaesthesia; Myelitis transverse; Paralysis	FLU3~EVANS VACCINES~E35822KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0195212	12/19/2002	TX	42.0	42		M	12/19/2002	Severe pain in joints of shoulders & elbows; chest pain (muscular); sleepiness, weakness started during the evening the vaccines were given, then worsened over the next two days.  Saw personal physician on the 3rd day - tests done, including EKG.  All tests wnl. Symptomatic treatment with ibuprofen, increased liquids.									Y	11/19/2002	11/19/2002	0	CBC, STRESS EKG NORMAL	UNK	PVT	ACTOS	NONE -TEMP 98.1	TYPE II DIABETES			1						1	Asthenia; Pain; Somnolence	FLU3~PFIZER\WYETH~4020011~4~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~236A6~1~IM~RA~HEP A + HEP B (TWINRIX)~1|IPV~SANOFI PASTEUR~W0063~1~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|TD~SANOFI PASTEUR~UO817AA~3~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0195257	12/19/2002	OK	75.0	75		F	12/19/2002	Patient developed abcess of tooth and high blood pressure 2 days after receiving vaccine.  After getting blood pressure treated, pt had tooth removed.  Pt developed headache, stiffness in neck and upper back.  Pt went to personal physician who prescribe physical therapy.  Pt went to physical therapy X2.  Pain is better at this time, but unresolved.  Headache continue.  Pt taking Motrin for pain and headaches.				Y					U	10/28/2002	11/05/2002	8		PUB	PUB	Amoxicillin prescribed for tooth abcess					1						1	Abscess; Headache; Hypertension; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~UO911BA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0191618	12/20/2002	IN	75.0	75		F	12/17/2002	Information has been received from a physician concerning a 75 year old white female who on 10/4/02 at 16:00 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent IM in the right deltoid (lot 641115/1160L). On 10/4/02 at 16:00, the pt was concomitantly vaccinated with a dose of influenza virus vaccine (Fluogen) IM in the left deltoid (lot U0911AA). It was reported that the pt received the vaccinations in a grocery store. On 10/5/02 at 12 noon, the pt's right arm became very swollen and sore. The pt became very weak and fell two times. The pt was seen by the physician and was admitted to the hospital. The pt was hospitalized for two days and was treated with IV antibiotics. Subsequently, the pt recovered. Additional info is not expected.				Y	Y	2			Y	10/04/2002	10/05/2002	1	UNK	PUB	PUB			UNK		WAES0212USA00274	1						2	Asthenia; Cellulitis; Dehydration; Diarrhoea; Fall; Injection site oedema; Injection site pain; Pyrexia; Vomiting; Asthenia; Fall; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U0911AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1160L~2~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~PARKDALE PHARMACEUTICALS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUOGEN)~2|PPV~MERCK & CO. INC.~1160L~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0192472	12/20/2002	PA	14.0	14		F	12/10/2002	Day after injection, red patch size of .50 piece increased to 3 in diameter by day 4. Fever for 2 days (temp 103 degrees). Nausea 2 days. Swelling, redness 6 days; Hard 4 days; Hot to touch 3 days.									Y	10/31/2002				PVT	PVT		NONE	Asthma			1						2	Injection site erythema; Injection site infection; Injection site oedema; Pain; Pyrexia; Injection site erythema; Injection site induration; Injection site warmth; Nausea; Oedema; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~IM~LA~PNEUMO (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U0934FA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0111M~1~IM~LA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0195230	12/20/2002	WA	15.0	15		F	12/10/2002	Weakness LE> UE worsening over the day x 6 days				Y					Y	11/01/2002	11/27/2002	26	NL  CBC, ESR, Screen, TSH, CPK,	PVT	UNK		URI 2 weeks prior				1						1	Asthenia	FLU3~SANOFI PASTEUR~U0932AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0195239	12/20/2002	UT	47.0	47		M		Local rash and pruritis. Treated with Benadryl (PO) and topical cortaid. Developed painful swelling and redness.									Y	12/04/2002	12/06/2002	2	NONE	PVT	PVT	Zyrtec	NONE	NONE			1						1	Erythema; Rash; Rash pruritic; Swelling	FLU3~SANOFI PASTEUR~U0981AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0165M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0195240	12/20/2002	GA	20.0	20		F	12/11/2002	Severe headache radiating to back, nausea, meningismus. Treated with Toradol initially; no relief; Subsequently treated with Flexil and Tylenol #3. Symptoms lasting 21 week.				Y					Y	12/08/2002	12/08/2002	0	CBC; differential count; ESR	PVT	PVT	NONE		NONE			1						1	Headache; Meningism; Nausea	FLU3~SANOFI PASTEUR~UO872AB~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~5305BU~3~IM~LA~HEP B (ENGERIX-B)~1|MEN~SANOFI PASTEUR~UB244AA~1~SC~RA~MENINGOCOCCAL (MENOMUNE)~1	USA	Emergency room visit	Influenza
0195252	12/20/2002	NH	36.0	36		F	12/16/2002	Individual experienced pain in right muscle and arm 45 minutes after receiving influenza immunization, Took Ibuprofen and exercise and applied cold compresses after calling Health Dept. later that day. Later still experiencing muscle pain and some weakness in right arm, Symptoms are off and on, NO redness swelling or bruising observed, Presently mild tenderness over injection site with pressure. Pain with movement and positioning of arm.									N	12/06/2002	12/06/2002	0	NONE; Individual called the doctor who called the immunization program. Was informed by her doctor after (?) should resolved in few weeks to few months.	PUB	PUB	Zyrtec, Orhotric-cyelene	NONE	No Hay fever, environmental allergies		NH028	1						1	Injection site pain; Muscular weakness	FLU3~SANOFI PASTEUR~UO937AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195287	12/23/2002		3.0			F	12/18/2002	Information has been received from the mother of a 3 year old female patient who on approximately 11/26/02 was vaccinated with a dose of varicella virus vaccine live. That same day, approximately 11/26/02, the patient was concomitantly vaccinated with a dose of influenza virus vaccine. No other concomitant medications or concurrent conditions were noted. Subsequently, the patient was losing her ability to walk, had weakness on the right side of the body, was unable to sleep at night, developed some coughing and was digging at her ear as if she had pain. Unspecified medical attention was sought. According to the mother, the patient was getting worse. At the time of this report, the patient was to be seen by a neurologist. Upon internal review, the patient's abasia was considered an other medical event (OMIC). Additional information has been requested.				Y					N	11/26/2002			UNK	OTH	OTH			UNK		WAES0212USA00708	1						1	Asthenia; Cough; Difficulty in walking; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~~UNK~~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0195292	12/23/2002	LA	62.0	62		F	12/02/2002	Pt states was out of it for three days post flu vaccine. States was tired and not up to par. Started after that had thick throat with swollen glands, back and neck pain, dry membranes x 1 month. Has not been to MD. Pt states has had previous flu vaccines without any problems.									U	10/30/2002	10/30/2002	0		PUB	PUB	ASA, Nyquil	NONE	Feathers, milk, dust, pcn, Mastectomy 1987, tonsilectomy, polio,tarmatic shock syndrome 68.		LA021202	1						1	Back pain; Fatigue; Lymphadenopathy; Mucous membrane disorder; Neck pain	FLU3~SANOFI PASTEUR~U093AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195293	12/23/2002	MO	91.0	91		M	12/18/2002	Fever, chills, muscle aches, scartchy throat, poor appetitie x 2 weeks.									Y	11/02/2002	11/04/2002	2	NONE	OTH	UNK			Non-Hodgkins lymphoma	Pneumonia and CHF~Pneumo (no brand name)~1~0.00~In Patient		1						1	Chills; Decreased appetite; Dry throat; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0195294	12/23/2002	ME	10.0	10		M	12/13/2002	Large (3 1/2x3inches) raised red swollen red area surrounding injection site.									Y	12/11/2002	12/12/2002	1	NONE	PVT	PUB	Zyrtec		Sinusitis-amox; seasonal environmental allergies			1						1	Injection site erythema; Injection site oedema; Injection site swelling	FLU3~SANOFI PASTEUR~U0904CA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195295	12/23/2002	UT	2.75	2	.8	F	11/18/2002	10/11/02 woke up from sleep crying. L arm red, swollen with lump. Taken to instacare, dx. cellulitis. Rx with Cephalexis.				Y					Y	10/09/2002	10/11/2002	2	NONE	PUB	PUB	NONE	Cold, no fever	NONE		UT022723	1						1	Agitation; Cellulitis; Injection site erythema; Injection site mass; Injection site oedema; Injection site reaction	DTAPH~SANOFI PASTEUR~U04855C~UNK~IM~LA~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~U0883AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0195296	12/23/2002	MD	74.0	74		M	12/19/2002	Pt had a flu shot at a community clinic 11/7/02. On 12/19/02 pt's wife called that pt developed itching at site on day following flu shot. Has seen family doctor on 2 occasions since, still itching. Will see dermatologist 12/20/02 as itching now involves much of bout.									U	11/07/2002	11/08/2002	1	UNK	PUB	UNK		UNK	UNK			1						1	Injection site hypersensitivity; Pruritus	FLU3~SANOFI PASTEUR~U0882AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195481	12/23/2002	CA	9.0	9		F	12/23/2002	Patient received vaccine for Influenza A/B on 11/5/2002.  Upon recent admission, respiratory culture was obtained and came back positive for Influenza A by FA.									Y	11/05/2002	11/19/2002	14	Viral Respiratory Antigens:  Positive for influenza A by FA Source:  nasal washings	PVT	PUB	Sporonox 100mg, Albuterol, Creon MT 20, ADEK vitamins, Zantac, Actigall	Cystic Fibrosis	Cystic Fibrosis, NKDA			1						1	Influenza	FLU3~SANOFI PASTEUR~U0943AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0194915	12/26/2002	AR	65.0			U	12/13/2002				Y	Y	Y			Y	U	10/30/2002	11/05/2002	6		OTH	OTH						1						2	Guillain-Barre syndrome; Paralysis; Guillain-Barre syndrome; Paralysis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0195346	12/26/2002	NY	83.0	83		F	12/12/2002	12/25/02 at 12 noon; tongue noted to be edematous and unable to swallow food. Given Benadryl and transported to ER c/o throat swelling and erythema to upper arms bilaterally. Dehydrated with hyponatremia. Rx: hydration, antibiotic-steroid IV. Diagnosed Stevens Johnson syndrome to drug reaction.	Y	11/23/2002			Y	10			N	10/23/2002	10/25/2002	2	Leukocytes 19,500, 92 cegs, 4 lymphs, 4 mono K: 5.6 NA: 119 K: 516 BUN 32 CHL 90	UNK	UNK	Paxil, Vioxx, Inderol, Premarin, Norvasc, Ativan	Infected total knee 5/02	DM, HTN, SIADH, osteoarthritis, malnurishment, bipolar disorder			1						1	Anxiety; Gastrointestinal disorder	FLU3~EVANS VACCINES~E35812CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0195371	12/26/2002	MD	38.0	37		M		Bells Palsy 2/27/02. Treated at hospital. 60 day follow up states pt has recovered.				Y	Y	1			U	12/03/2001	02/27/2002	86		MIL	MIL		Bells Palsy	Gout, Hypertension, Testicular Cancer			1						1	Facial palsy	FLUX~UNKNOWN MANUFACTURER~U0704AA~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0195376	12/26/2002	TN	31.0	31		F	12/16/2002	Left deltoid (upper arm) discoloration (eczematous skin patch)- 2 weeks post vaccination & resolved Returned again 12/10/02, Tx: Fluocinonide AM BID 2weeks.									U	11/07/2002	11/21/2002	14	NONE	UNK	PUB	NONE	NONE	Seasonal Allergy			1						1	Eczema; Skin discolouration	FLU3~SANOFI PASTEUR~UO926GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195377	12/26/2002	CA	25.0	25		M	12/06/2002	Positive puncture erythematous papules over B/L anticubital spaces, elbows RLQABD, Axilla, Atarax PRN									Y	12/04/2002	12/06/2002	2		MIL	MIL		NONE	NONE			1						1	Erythema; Rash papular	ANTH~EMERGENT BIOSOLUTIONS~~2~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~3~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~3~~~HEP A (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~2~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0195378	12/26/2002	MN	76.0	76		F	12/06/2002	Dizziness,nausea, exhaustion, chills lasted for 2 days, Was exhausted for 2 more days									Y	11/06/2002	11/18/2002	12	NONE	PUB	OTH	synthroid	NONE	DM, Hypothyroid			1						1	Chills; Dizziness; Fatigue; Nausea	FLU3~SANOFI PASTEUR~U0939AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195380	12/26/2002	MO		58		F	12/11/2002	Developed weakness in both legs. Could hardly walk approximately five days post vaccination. Gradually got better after approximately one month. Muscles in legs remain slightly tingly. *F/UP report 4/1/03: A doctor's note has the following: Fatigue, malaise, hypertension, pre-diabetic state, hypothiroiditis, polymyalgia after flu shot.*									Y	10/17/2002	10/22/2002	5	Urinary frequency	PUB	UNK						1						1	Asthenia; Fatigue; Gait disturbance; Hypertension; Hypothyroidism; Malaise; Myalgia; Paraesthesia	FLU3~SANOFI PASTEUR~U0924DA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195381	12/26/2002	CA	34.0	34		F	10/31/2002	Thirty minutes after vaccine administration developed palpitations, sweating, diaphonesis, dizziness and pruritus on her chest. Treated with Propranalol 20mg PO. Benadryl 50mg PO, Decadron 4mg IM				Y					Y	10/29/2002	10/29/2002	0		PUB	PUB	Zestoretic	NONE	NONE			1						1	Dizziness; Hyperhidrosis; Palpitations; Pruritus	FLU3~PFIZER\WYETH~U0885AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0195383	12/26/2002	CA	84.0	84		F	12/16/2002	Local rash and raised bumps for 3 days. Resolving 12-16-02.									Y	12/13/2002	12/14/2002	1		PVT	UNK	Vicodine, Sinemex	Leukemia, Chronic Lymphocytis	Allergic to NSAIDS, Reglan, Miacalcin, Derum			1						1	Rash maculo-papular	FLU3~PFIZER\WYETH~U0987012~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0195384	12/26/2002	OH	43.0	43		F	12/16/2002	Approximately 20 hours after vaccine she got up to go to work and felt extremem pain from shoulders to mid-thighs (bone pain). Also had numbness and tingling in hands, feet and forehead. On 10/24/02 appointment was made with MD. Medrol dose pack prescribed, off work 4 days. Flexoril for final relief of pain on 10/28/02.				Y					Y	10/21/2002	10/22/2002	1	NONE	PVT	PVT		NONE				1						1	Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U0929AA~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0195385	12/26/2002	NY	58.0	58		M	12/10/2002	One week after influenza vaccination, developed headache, flu-like symptoms and double vision. Seen by op				Y					N	11/01/2002	11/08/2002	7		PVT	PVT	Liptor, Altace	NONE	Spinal fusion for (unknown)6/14/01; Hx 6th nerve palsy			1						1	Diplopia; Headache; Influenza	FLU3~SANOFI PASTEUR~U0934CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0195388	12/26/2002	GA	45.0	45		F	12/10/2002	Swelling, hard nodule size of a quarter immediately following injection. Gave Benadryl.									Y	12/10/2002	12/10/2002	0		OTH	OTH		NONE	NONE			1						1	Injection site mass; Oedema	FLU3~SANOFI PASTEUR~U0922AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195389	12/26/2002	NV	76.0	76		F	12/18/2002	Patient complained of immediate pain in right arm after flu shot. No numbness or tingling. Range of motion of right arm was limited due to pain, however, she now has almost full range of motion without pain most afternoons. She still complains of intermittent swelling and pain in morning; relieved by rubbing arm, Ibuprofen, and ROM exercises.				Y					N	11/15/2002	11/15/2002	0	NONE	PVT	UNK	Ibuprofen only since flu shot.	NONE				1						1	Joint range of motion decreased; Pain; Swelling	FLU3~SANOFI PASTEUR~U0926EA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0195390	12/26/2002	TN	65.0	65		F	11/12/2002	Patient received flu and pneumonia shot on 11/6/02. At 10PM that night, right arm red and swollen. Came to health department 3:30PM 11/7/02 for evaluation; sent to ER, private MD notified by CFNP. told to take Benadryl by mouth and put cold compresses on site.				Y					U	11/06/2002	11/06/2002	0	Accucheck 213mg/dl non-fasting.	PUB	UNK	Insulin, BP medicine, heart medicine, thyroid medicine	NONE	IDDM, Hypertension, CAD		TN02050	1						1	Erythema; Swelling	FLU3~SANOFI PASTEUR~U0925AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0111M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0195391	12/26/2002	TN	65.0	65		F	10/30/2002	Complained of left arm redness, heat at site, inflammation, 1/4 elevation approximately 3x3. Instructed to use cold compresses 24 hours then heat 24-48 hours and Benadryl PO as directed. 24 hours, call PCP if no improvement.									Y	10/28/2002	10/29/2002	1		PUB	PUB	NONE	NONE			TN02054	1						1	Injection site erythema; Injection site inflammation; Injection site warmth	FLU3~PFIZER\WYETH~4020020~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0675M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0195392	12/26/2002	TN	67.0	67		F	10/28/2002	Patient called clinic 10/25/02. Had flu shot on 10/23/02. Had reaction at site; red, swollen, itching around site. 5-6 diameter. Applied ice 10/24/02 and heat 10/25/02. Told her to take Tylenol for fever and Benadryl for itching and to call 10/28/02 and let us know how she's doing.									Y	10/23/2002	10/24/2002	1		OTH	PUB			Sulfa, Mercury, Bee Stings		TN02056	1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Pruritus	FLU3~PFIZER\WYETH~4020030~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0195393	12/26/2002	TX	63.0	63		F	11/15/2002	11/9/02 1/2 below injection site red area 1.5 by 2 with itching. Patient rubbed area with alcohol; took Benadryl. Area faded and disappeared within 2 days. 11/15/02 Same area became red with some itching. Benadryl (PO) rubbed area with cortisone ointment 11/18/02. No other problems.									Y	11/08/2002	11/09/2002	1		PUB	PUB					TX02132	1						1	Injection site erythema; Injection site hypersensitivity; Pruritus	FLU3~SANOFI PASTEUR~U0911BA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0527AA~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0195394	12/26/2002	TX	39.0	39		F	12/12/2002	Red areas to arm of injection site; warm to touch. Reports arm was approximately 1 to 1.5 larger than other arm. Firm and tender to touch. Had 1x1 bruise to injection site. Below that, there was a 1x1/2 red mark below that there was a 3/4x1/8 red mark.				Y					U	12/09/2002	12/09/2002	0	NONE	PUB	PUB	Avonex 30mg IM weekly	NONE	MS		TX02136	1						1	Contusion; Feeling hot; Injection site erythema; Injection site induration; Tenderness	FLU3~SANOFI PASTEUR~U0877AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0995L~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0195395	12/26/2002	AK	50.0	50		F	12/10/2002	Reports red, swollen, very sore local reaction. Redness and swelling extended to elbow. Soreness was very intense. On 12/2/02 reports experiencing asthma attack, was very SOB/difficult breathing. Was seen by NP and prescribed erythromycin. Was bed ridden the entire week and seen again last in ER 12/8/02. Diagnosed with pneumonia. Was doubled in dosage. Local reaction resolved.				Y					N	11/27/2002	11/28/2002	1		PUB	PUB			Asplenia		AK200258	1						1	Dyspnoea; Injection site erythema; Injection site oedema; Injection site pain; Injection site reaction; Pneumonia	FLU3~SANOFI PASTEUR~U0885AA~4~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0735M~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0195396	12/26/2002	WI	54.0	54		F	11/12/2002	Hives developed on left cubital area, left fore arm, left deltoid, left side of neck. Areas red/rounded approx. 1/2cm in circular formation. Beandryl and ice pack for tx ordered by Dr.									Y	11/06/2002	11/08/2002	2		OTH	UNK	NONE	NONE	NONE		WI0225	1						1	Erythema; Urticaria	FLU3~PFIZER\WYETH~4020036~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0195397	12/26/2002	WI	0.5	0	.5	F	11/05/2002	Vaginal bleeding occurred 11/3/02.									Y	10/30/2002	11/03/2002	4	NONE	PVT	PVT	NONE	NONE	NONE		WI0224	1						1	Vaginal haemorrhage	DTAP~SMITHKLINE BEECHAM~572A2~3~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U0911AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~U0614~3~SC~LL~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0195398	12/26/2002	WI	55.0	55		F	10/08/2002	Pt states that R arm became red, swollen and warm approx 2 hrs after the inj. This did not happen when she received her first pneumonia inj 8-10 ago. She also states that her arm had much of the same reaction from the flu inj last year, but not this year.									Y	10/04/2002	10/04/2002	0		PUB	PVT	3 inhalers, Synthroid, Prempro, Nasocort, Zoloft, Pepcid	NONE	Asthma, depression, hypothyroid and hyperacidity		WI0217	1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U0886AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1352L~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0195399	12/26/2002	WI	1.08	1	.1	M	11/25/2002	On 11/16, child woke up with fever-102 degrees. Fever off and on x 3 days. On 11/19-developed rash; red; flat rash on trunk, red, hairline, sl on arms/legs, buttocks. Rash lasted 6 days. Given Benadryl, Tylenol, Motrin.									Y	11/07/2002	11/16/2002	9	NONE	PUB	PUB	NONE	NONE	NONE		WI0229	1						1	Erythema; Pyrexia; Rash	FLU3~PFIZER\WYETH~4020036~1~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|MMR~MERCK & CO. INC.~0635M~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0563M~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0195400	12/26/2002	WI	56.0	56		M	11/14/2002	Developed hives, itching on 11/4/02, occurring over sporadic areas: started top of his head, varying in duration. Reports ankle furion surgery on 10/28/02 by MD, described as a repeated surgery after a curshing ankle injury 7/99 and history of treatment for osteophlebitis.									Y	10/22/2002	11/04/2002	13		PUB	PUB	Pain pill after ankle furion done 10/28/02		Sulfa allergy; history of osteomyelitis; ankle surgery 10/28/02		WI0228	1						1	Pruritus; Urticaria	FLU3~PFIZER\WYETH~4020015~3~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0195401	12/26/2002	WI	76.0	76		F	11/04/2002	11/4/02 total body itching. Rash all over body-not raised. Took Alpraxolamo any swelling or difficulty breathing. Resolved by 11am. Started 6:30pm. No call HCP.									Y	10/29/2002	10/29/2002	0	NONE	PUB	PUB	ASA, iron, Dilftiazem, Buroscmide, Levatoid, Hatapropol	NONE	CabPG 12/01, allergies Benadryl, iodine, codeine	~Vaccine not specified (no brand name)~~0.00~In Sibling	WI0227	1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U0879AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195402	12/26/2002	GA	55.0	55		F	11/21/2002	Onset generalized urticaria 1 wk post receiving flu and pneumonia vaccines not responding to Zyrtec. No respiratory, swallowing, breathing problems-no fever, chills, NVD. Required Medrol dose pack.				Y					Y	10/16/2002	10/23/2002	7		PUB	PUB	Furasemide, Zyrtec, Aceon, Premarin	NONE	Urticaria episodic, seasonal allergies, HTN, OA, reflux		GA02127	1						1	Urticaria	FLU3~EVANS VACCINES~33482HA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1160L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0195403	12/26/2002	GA	53.0	53		F	11/26/2002	Client states she received the flu vaccine on 11/19/02 and on Fri 11/22/02 she noted a rash on the top of her thigh close to the hip joint. She bathed it with water as it itched. On Sat 11/23/02 the rash had gotten and she applied on antifungal cream x 2 that day. Had no fever Fri or Sat. On Sun 11/24/02 she still had the rash and applied on antifungal cream x 2 that day. No fever. On Mon 11/25/02 the rash had increased to the size of a quarter and see had no fever but the increased warmth to area and it continued to itch and she applied Bacitracin cream to it. States the rash really concerns her as well as the itching. Client states she was treated for a urinary tract infection on Sat. 11/16/02 at the health center. States the doctor prescribed an antibiotic named Septra one tablet po BID #14 and she took the last tablet on Fri 11/22/02. States she was also given a prescription for Pyridium one tablet po QID for bladder pain and discomfort and she stopped taking it on Thurs. 11/21/02 and she has nine pills left. States she was treated for bronchitis with an antibiotic on last year but she can not remember the name but she had no problems with it. Client states after she received the flu vaccine on 11/19/02 in her right arm she noted that the area was red for a couple of days but it went away. Client states she has no primary care physician. RN discussed signs and symptoms of local and possible systemic reactions to influenza vaccine and advised use of Tylenol tablets (if she can take it) for pain and discomfort and may apply a cool wet cloth or ice pack to rash fifteen minutes at a time only and then she needs to seek MD evaluation of the rash as it could be a possible allergic reaction to the Septra tablets on the Pyridium tablets that she had taken. Client verbalized understanding and stated she would seek MD evaluation.									U	11/19/2002	11/22/2002	3	NONE	OTH	PUB	Septra tablet po BID, Poridurn talbet po QID	Under treatment for dx of URI on 11/16/02	NONE		GA02128	1						1	Injection site erythema; Pruritus; Rash	FLU3~EVANS VACCINES~E31172GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0195404	12/26/2002	ID	44.0	44		F	11/14/2002	Red itchy blotch at site approx 4 hrs (warm site). Itching all over approx 10 hrs until Benadryl took effect.									Y	11/05/2002	11/05/2002	0	NONE	OTH	OTH	Zyrtec, Estradinlen, Auphex, Lesapro, Tmgadrin	NONE	Mold allergy, sulfa allergy, tetanus allergy, depression, asthma, gastric reflux	Sore iste, red swollen~Tetanus Toxoid (no brand name)~~26.00~In Patient	ID02071	1						1	Injection site erythema; Injection site hypersensitivity; Injection site warmth; Pruritus; Rash macular	FLU3~EVANS VACCINES~E31892HA~4~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0195405	12/26/2002	ID	43.0	43		F	10/29/2002	Had influenza vaccine 10/28/02. On 10/29/02 developed hives all over-especially in warm areas of body. Tried Benadryl-stated continued to get worse. Instructed to see MD stat. Follow up TC 11/5/02. Seen at hosp ER x 2 2 hrs on 10/29 then again 11:15pm 10/29 and observed til 5am 10/30/02. Given Benadryl, Epenipherine and steroids in ER.				Y					Y	10/28/2002	10/29/2002	1	NONE	PUB	PVT		NONE	NONE		ID02073	1						1	Urticaria	FLU3~PFIZER\WYETH~4020026~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0195406	12/26/2002	FL	8.0	8		F	12/09/2002	Bullous vesicles 48 hrs post injection at injection site with mild surrounding erythema. Tenderness-txed with Keflex x 10 days.				Y					U	12/04/2002	12/06/2002	2	NONE	PUB	UNK	PPD	NONE	Allergy PCN			1						1	Dermatitis bullous; Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U0881AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W0010~5~IM~RA~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0195409	12/26/2002	ID	46.0	46		F	11/26/2002	Client took 1st dose of oral typhoid at 9:30am on 11/24/02-experienced nausea, dizziness, some diarrhea c/o feeling drugged passed out at 6:30pm-was seen in the ER. They sent her back to health dept for follow up R/T immunizations.				Y					Y	11/24/2002	11/24/2002	0		PUB	PVT					ID02072	1						1	Diarrhoea; Dizziness; Loss of consciousness; Nausea	FLU3~PFIZER\WYETH~4020037~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEPAB~SMITHKLINE BEECHAM~235A4~UNK~IM~RA~HEP A + HEP B (TWINRIX)~1|IPV~SANOFI PASTEUR~U1233~UNK~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|TD~UNKNOWN MANUFACTURER~U0528AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~3000021~1~PO~MO~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0195474	12/26/2002	KS	33.0	33		F	12/18/2002	10/20/02 Generalized tonic/clonic seizure			Y	Y					Y	10/15/2002	10/20/2002	5	All negative	PVT	PVT						1						1	Convulsion	FLU3~SANOFI PASTEUR~U0918AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0195476	12/26/2002	CA	3.0	3		F	12/18/2002	Guillain Barre type neuropathy with paralysis of lower limbs. 60 DAY FOLLOW UP STATES THAT IT IS UNKNOWN IF PT HAS RECOVERED. THIS PT DOES NOT COME TO OUR OFFICE ANYMORE SINCE THE INCIDENT. SHE HAS CHANGED HER PRIMARY CARE PHYSICIAN.				Y	Y	10		Y	U	12/09/2002	12/12/2002	3		PVT	PVT						1						1	Guillain-Barre syndrome; Neuropathy; Paralysis	FLU3~PFIZER\WYETH~4020034~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0195478	12/26/2002	CO	2.0	2	.0	F	12/13/2002	2 Injections (DTAP and Hep A) given right upper thigh 12/09/2002. Pt developed erythematous and bluish rash and swelling approx. 3 x 5 inch area. Seen in clinic 12/12/2002. No fever, started Benadryl and ice. Decreased symptoms 12/13/2002.									Y	12/09/2002	12/09/2002	0		PUB	PUB	Augmentin	Right serious otitis, diaper rash, left lower lobe pneumonia			CO02046	1						1	Injection site erythema; Injection site oedema	DTAP~SANOFI PASTEUR~U0848BA~4~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U0877AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0582M~1~IM~RL~HEP A (VAQTA)~1	USA		Influenza
0195480	12/26/2002	TX	5.0	5		F	12/17/2002	Given Influenza vaccination on 12/12 0.5 cc. client has had no previous flu shots. Mom gave 1 tsps. Children's Motrin after injection. Client had no fever that night or at all. on 12/13 pm rash began on face and chest; red, itchy bumps appearing as chill bumps. Injection site red , swollen like a ball, no fever. Seen in ER on 12/14/2002, Sat night0 was given po Benadryl, injection of unknown med and Rx for pills, mom did not meds available at this time. 12/17/2002 rash almost gone.				Y					Y	12/12/2002	12/13/2002	1	PPDT 12 mm on 07/07/2002	PUB	PUB	07/30/2002 INH 300mg po qd	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Pruritus; Rash; Rash erythematous	FLU3~SANOFI PASTEUR~6083AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0195488	12/26/2002	OH	51.0	51		M	12/18/2002	Three hours after injection, developed headache, throat sore, no fever, no sweats, no rash, no cough, no diarrhea, no redness. Joints, knees, fingers, elbow aching. Symptoms x 5 days				Y					U	11/22/2002	11/22/2002	0	NONE	PVT	PVT	Glucophage 500 mg  BID, Celexa 20 mg qd, Prevacid 30 mg QD	Fatigue	DM 2, Sleep Disorder, GERD, COPD			1						1	Arthralgia; Fatigue; Headache; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U0924DA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0541M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0195489	12/26/2002	DE	37.0			F	12/18/2002	Severe malaise, myalgias, light headedness, sinus pressure, chills and sweats for 16 hours.									Y	12/10/2002	12/10/2002	0	NONE	PVT	PVT	Ortho Erra, Eflexon, Sorata	NONE	NONE			1						1	Chills; Dizziness; Hyperhidrosis; Malaise; Myalgia; Sinus congestion	FLU3~PFIZER\WYETH~4020015~7+~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0195490	12/26/2002	MI	68.0	68		F	12/17/2002	Less than 24 hours after injection, pt noted more that normal soreness to left upper arm. Increased pain/ aching on movement. Left arm felt warm. Arm was ore for about 3 days, then felt much improved.									Y	12/09/2002	12/09/2002	0	NONE	PUB	PUB	Fosamax	NONE	NONE			1						1	Feeling hot; Hypokinesia; Injection site pain; Pain	FLU3~SANOFI PASTEUR~U0946AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0165M~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0195491	12/26/2002	WI	43.0	43		F	11/19/2002	Both arms, pain in arms lot, Flu had more 1st. Twisted feeling, heavy arms- 3 to 4 days. No sight pain, poor grip, no tingling, couldn't lift . unable to sleep for 3 days.				Y					Y	10/18/2002	10/19/2002	1	NONE	PUB	UNK	NONE	NONE	NONE			1						1	Abdominal pain; Injection site pain; Insomnia; Sensation of heaviness	FLU3~PFIZER\WYETH~4020025~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~SANOFI PASTEUR~U0521AA~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0195492	12/26/2002	MN	60.0	60		F	12/16/2002	Faint spell and leg pain the morning after a flu shot.									Y	12/03/2002	12/04/2002	1	EKG- block and ST changes- increase	PVT	UNK	Verapamil, Ambien	NONE	Atrial fibrillation			1						1	Pain; Syncope	FLU3~SANOFI PASTEUR~U0946AA  exp 06~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195493	12/26/2002	VA	65.0	65		F	12/21/2002	At time of vaccination, it felt like she had thrown a dart into my upper arm and shoulder that was loaded with all the vaccine. The next day my arm was sore but with each day it kept getting worse not better. I called my doctor, and she suggested 600mg Ibuprofen 3-4x/day. Still recovering.				Y					N	11/07/2002	11/08/2002	1		PUB	UNK	Premarin, Norvasc, HctZ, Fosamax		Hypertension, osteoporosis			1						1	Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0195494	12/26/2002	CA	37.0	37		F	12/02/2002	Shot given about 12:30pm. AT 16:30 started to have sweaty palms, chet tightness, lightheaded-went to urgent care at 17:30. EKG-labs done all neg. Has strong maternal hx CAD with mother having MI at 15 y/o and three inches dead CAD. No meds or tx given in ER. MD felt panic atttack. Pt admitted having stress-two toddlers, in-laws in town, delivery person felt her reaction not from the flu shot.				Y					Y	11/23/2002	11/23/2002	0	EKG-neg; TSH negs, CK+LDH neg, O2 sats 100% on admit	PUB	PUB		NONE	Allergic codeine-Temerol			1						1	Chest discomfort; Dizziness; Hyperhidrosis; Panic reaction	FLU3~SANOFI PASTEUR~U0940AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0195496	12/26/2002	FL	43.0	43		F	12/18/2002	Broke out in bad rash and had severe itching. Rash went away after about a week, but continue to itch.				Y					U	10/07/2002	11/04/2002	28		PUB	PVT		NONE	NONE			1						1	Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~1~~~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~1~~~HEP A (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~~UNK~~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0195497	12/26/2002	CA	25.0	25		F	12/06/2002	Cellulitis R arm. Warm to touch, + erythemia, + edema, from shoulder to elbow.									Y	12/04/2002	12/04/2002	0		MIL	MIL	Demorol/Vicodine	NONE				1						1	Cellulitis; Injection site erythema; Injection site oedema; Injection site reaction; Injection site warmth	ANTH~EMERGENT BIOSOLUTIONS~FAV063~6~SC~~ANTHRAX (BIOTHRAX)~1|FLU3~PFIZER\WYETH~4020032~6~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0195498	12/26/2002	CO	82.0	82		F	12/17/2002	11/15/02 0.25cc Fluvirin IM L deltoid. 11/18/02 call from answering service. Call to pt stated she had extreme saliva production post vaccine, slurred speech. Had episode of being unable to lift arm. Denied rash, itching, throat tightening. Referred to hospital ER, to rule out CVA. Normal neuro exam at ER.				Y					Y	11/15/2002	11/15/2002	0		PVT	PVT	Laroxin, T4, T3, Doxepin, Klonepin, Ambien, Trazadone	NONE	S/P lung CA, hypothyroid, polyarthralgia, incomplete R BBB, trace mitral valve			1						1	Dysarthria; Joint range of motion decreased; Salivary hypersecretion	FLU3~EVANS VACCINES~E33402HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0195499	12/26/2002	OR	37.0	37		F	10/29/2002	Diffuse 1/2 circle red rash below injection site. Hard and warm to the touch.									Y	10/25/2002	10/26/2002	1		OTH	PVT						1						1	Injection site induration; Injection site rash; Injection site warmth	FLU3~SANOFI PASTEUR~U0875AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0675M~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0195500	12/26/2002	OR	56.0	56		F	10/29/2002	Diffuse 1/2 circle red rash below injection site. Hard and warm to touch. Reaction had cleared up by 10/30/02.									Y	10/25/2002	10/25/2002	0		OTH	PVT						1						1	Injection site induration; Injection site rash; Injection site warmth	FLU3~SANOFI PASTEUR~U0875AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195501	12/26/2002	OR	65.0	65		F	12/01/2002	Diffuse 1/2 circle red rash below injection site. Hard and warm to the touch.									Y	11/26/2002	11/27/2002	1		OTH	PVT						1						1	Injection site induration; Injection site rash; Injection site warmth	FLU3~SANOFI PASTEUR~U0932AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195541	12/27/2002	LA	79.0	79		F	11/26/2002	Severe sore throat, flu-like symptoms, severe cough, breathing difficulty, pneumonia of left lung. Admitted to hospital 11/14/01; discharged 11/24/01. Readmitted 11/25/01 and discharged 11/30/01. The discharge summary states congestive heart failure, and hypernatremia. Annual follow up on 01/28/04: Pt died on 03/25/03, unrelated to vaccine.			Y	Y	Y	14	Y		U	10/30/2001	11/14/2001	15	X-rays, Swan Cath; Echocardiogram; EKG's; Heart Cath.	UNK	PUB	Atenolol		Penicillin; Keflex; Lasix, HBP	Similar to this but less severe~Influenza (Seasonal) (no brand name)~1~75.00~In Patient		1						1	Cardiac failure; Cardiomyopathy; Cardiovascular disorder; Cough; Dyspnoea; Hypernatraemia; Influenza like illness; Pharyngolaryngeal pain; Pneumonia	FLU3~SANOFI PASTEUR~U0594AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0195543	12/27/2002		36.0			F	12/09/2002	Patient received pneumovax and flu vaccine in left deltoid on 12/3/02. (Hx received flu vaccine in past without reaction). Within 8 hours of vaccines reported fever 104. Left arm swollen, hot, painful and unable to use arm. 12/6/02 exam. Afebrile slight swelling deltoid. No warmth. Quite painful with minimal movement of shoulder.								Y		12/03/2002	12/03/2002	0		UNK	UNK			Allergy to PCN, erythromycin			1						1	Hypokinesia; Oedema; Pain; Pyrexia; Vasodilation procedure	FLU3~SANOFI PASTEUR~U0927AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1353L~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0195545	12/27/2002	OK	48.0			F	11/25/2002	Swollen arm- breast and armpit. Fever 72 hours of 103 degrees. Bronchitis. CBC with 58 seq and 15 esimophils x 3 weeks then Bells Palsey on side of injection				Y					Y				CBC	PVT	PVT		NONE	NONE		OK0254	1						1	Bronchitis; Facial palsy; Oedema; Pyrexia	FLU3~EVANS VACCINES~E35582HA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~476956~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0195546	12/27/2002	VA	73.0	73		M	12/16/2002	Flu vaccine was administered right deltoid 12/09/2002. Soreness at injection site intensified and progressed to right shoulder by 12/11/2002 and into left shoulder and arm by 12/13/2002. No improvement noted by 12/16/2002. 12/19/2002 Improved per pt.									Y	12/09/2002	12/09/2002	0	NONE	PUB	PUB	NONE	NONE	Arthritis		VA02039	1						1	Injection site pain	FLU3~PFIZER\WYETH~4020021~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0195547	12/27/2002	TX	64.0	64		F	12/17/2002	On 12/17/2002, pt reports Influenza vaccine administered on 12/10/2002 at injection site redness/ swelling size of silver dollar on 12/14/2002. No meds required. used compresses to site. Resolved 12/16/2002.									Y	12/10/2002	12/14/2002	4	NONE	PVT	PVT	Amaryl, Nifedipine, ASA, Plavix, Altar, Zocor, Antivert, Paxil	TIA, NIDDM II	NONE			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U0982AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195578	12/27/2002	UT	7.0	7		M	12/16/2002	Left deltoid swelled about 40% greater than right deltoid. Erythema of entire area of deltoid muscle. Positive blanching; positive pain to touch; positive warm to touch. No line of lymphatic extention.									Y	11/11/2002	11/12/2002	1	NONE	PVT	PVT						1						1	Erythema; Feeling hot; Injection site discolouration; Pain; Swelling	FLU3~PFIZER\WYETH~4020035~1~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0195588	12/27/2002	CA	4.8	4		M	12/26/2002	Child presented 3 D post IZ's given. Mom states that he had swelling, redness and pain of his L arm on day of IZ's than day presented. Hot to touch.									Y	12/06/2002	12/06/2002	0		PUB	PUB	NONE	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	DTAP~SANOFI PASTEUR~U0583AA~5~IM~RA~DTAP (TRIPEDIA)~1|FLU3~PFIZER\WYETH~4020036~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|IPV~SANOFI PASTEUR~U1645~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0545M~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0195631	12/27/2002	CA	56.0	56		F	12/27/2002	Complained of severe headache on 11-19-02. Seen in Emergency Room on 11-22-02. Cat Scan & Lumbar puncture done. Hospitlized 11-22-02 to 11-29-02 at hospital.					Y	7			Y	11/13/2002	11/19/2002	6		UNK	PVT	Neurontin	None. Received vaccine thru community outreach clinic.	Allergies: Diflucan, No other conditions			1						1	Headache	FLU3~EVANS VACCINES~E37182KA~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0195597	12/30/2002					M	12/26/2002	A female reported that her adult brother received an injection of influenza virus vaccine  on 12/5/02. The pt was seen in the ER for fever and rash, white blood count was increased. No medications were prescribed; however, the pt was admitted to the psychiatric ward. The reporter declined to provide a specific reason or diagnosis and was held until 12/10/02. At that time he was seen by another physician who released him. That physician felt he should have never been in the psychiatric ward. Since that time he has had episodes of excessive eating and drinking, difficulty sleeping, and severe pain in the groin. He has been to the ER three times since and a diagnosis of epididymitis was made; however, they could not find any cause for his other symptoms. The reporter declined further info.				Y	Y	4			U	12/05/2002	12/06/2002	1	White blood cell count increased 12/6/02	OTH	OTH	UNK	UNK	UNK		HQ5852019DEC2002	1						1	Epididymitis; Groin pain; Hyperphagia; Insomnia; Pyrexia; Rash; Thirst; White blood cell count increased	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0195598	12/30/2002	AZ	33.0			F	02/07/2003	A pharmacist reported that a 33 year old female received an injection of Flu Shield on 12/6/02. *On 12/7/02,* she developed severe back pain. She was hospitalized on 12/12/02 because of her complaints of severe back pain, severe abdominal pain, and severe headache. She was worked up for some sort of neurological problem, but as of 12/16/02, were unable to determine the cause of her severe pain. The reporter noted that the pt had neither a fever, nor any local reactions to the vaccine. *She recovered.* No further info was available as of the date of this report. *F/UP report on 2/12/03: Info received from the reporter indicated that the PT recovered and that the first symptom onset was 12/7/02.*					Y				U	12/06/2002	12/07/2002	1	UNK	PVT	OTH	UNK	UNK	Overweight; smoker; subdural haematoma		HQ5815917DEC2002	1						1	Abdominal pain; Back pain; Headache; Nervous system disorder	FLU3~PFIZER\WYETH~4020006~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0195602	12/30/2002	AZ	26.0	26		M	11/08/2002	Redness severe swelling R arm past elbow.									Y	11/05/2002	11/06/2002	1	NONE	MIL	MIL						1						1	Injection site erythema; Injection site oedema	ANTH~EMERGENT BIOSOLUTIONS~FAV062~1~~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195605	12/30/2002	NC	24.0	24		M	12/20/2002	Pt has flu like symptoms, vomiting, diarrhea, chills, loss of appetite.				Y					Y	12/19/2002	12/20/2002	1	NONE	MIL	MIL	NONE	NONE	Penicillin			1						1	Anorexia; Chills; Diarrhoea; Influenza like illness; Vomiting	ANTH~EMERGENT BIOSOLUTIONS~FAV066~1~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U0984AA~5~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0195610	12/30/2002	VA		48		F	11/04/2002	Received a call from above employee stating that she received Flu shot yesterday 11/4/02 and towards the evening, noticed itchy-like reddish spots all over her body. Plans to contact MD about this reactions today.									Y	11/04/2002	11/04/2002	0		PUB	PUB	Baxtra					1						1	Erythema; Pruritus	FLU3~SANOFI PASTEUR~U0913AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195611	12/30/2002	SC	51.0	0	.7	F	12/27/2002	Within one day-swelling-half dollar size- around site of vaccine. Beginning 12/10/02-much gastrointesfinal discomfort and pelvic pain-resulting in trips to gynecologist and ER.				Y					U	12/07/2002	12/08/2002	1	Blood work-up, urinary vaginal cultures, pelvic ultrasound (all negative)	PVT	OTH	Azelastine, HCL, macrobid, nasal spray	Chronic Lyme disease	Chronic Lyme disease; immune responses to Acacia, gum, Latex, mercury, metallic catalysts; mitral valve prolapse; allergies to silk feathers, animal hair, dust, tree; fibroid uterus	Flu symptoms~Influenza (Seasonal) (no brand name)~~33.00~In Patient		1						1	Gastrointestinal disorder; Injection site oedema; Pelvic pain	FLU3~SANOFI PASTEUR~4751~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0195612	12/30/2002	OK	40.0	40		M	12/16/2002	One day after flu shot c/o SOB. Saw PCP on third day after shots. Treated with Proventil. Condition improved within 4 days.				Y					Y	12/08/2002	12/09/2002	1	NONE	MIL	MIL		NONE	NONE			1						1	Dyspnoea	FLU3~PFIZER\WYETH~4020032~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0195613	12/30/2002	OK	19.0	19		M	12/16/2002	Carbuncle lesions on right arm, lower abdomen and lower extremities, Onset 3 days after shot Still present 9 days later. Tx with Keflex (began today) 500mg PID X 10 days.				Y					N	12/07/2002	12/10/2002	3	NONE	MIL	MIL		NONE	NONE			1						1	Carbuncle; Skin ulcer	FLU3~PFIZER\WYETH~4020032~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0195614	12/30/2002	NY	1.46	1	.5	M	12/02/2002	High temperature, Cough. c/o low grade fever and cough which appeared on 11/16/2002. 2 days after vaccination. Pt was seen on 11/18/2002. He was in satisfactory condition. No fever. Physical findings: nasal congestion and erythema of posterior wall of pharings. Dx URI, pharyngitis. Rx: Rediscare 3/4 t sp Q ID, Motrin QID PRN				Y					Y	11/14/2002	11/15/2002	1	Blood Test	PVT	PVT	Roudec OM 1disp. QID	Respiratory infection no fever	NONE			1						1	Cough; Erythema; Nasal congestion; Pharyngitis; Pyrexia; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~U0966BA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0195615	12/30/2002	WA	43.0	43		M	12/14/2002	I was working in the ER. At the end of my shift, I asked the OB nurse to give me my flu shot. She did and 1 - 1.5 hours after I broke out in hives all over. this has never happened prior.				Y					Y	11/15/2002	11/15/2002	0	Hives	MIL	PUB		NONE	Hypothyroid, DMII			1						1	Urticaria	FLU3~EVANS VACCINES~U089188~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0195628	12/30/2002	CA	62.0	62		M	12/23/2002	After i received the flu shot in early Nov 2002, I became nauseous and dizzy. Today is Mon. Dec. 23,2002 and I continue to be nauseous, dizzy and my balance is bad. When I close my eyes, i spin , I also got a severe sinus infection. I was quite and felling very good until I received the flu shot									N	11/09/2002	11/11/2002	2		PUB	UNK		NONE	Injury to nerves in left foot in April 2000 (and leg)			1						1	Balance disorder; Dizziness; Nausea; Sinusitis	FLU3~SANOFI PASTEUR~U0940AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195650	12/31/2002	KS	40.0	39		F	12/30/2002	Pt reported to ER c/o wheezing, fever and erythema/swelling of L upper extremity. Pt seen in ER 11/5/02. Admitted to inpatient medical unit for IV normal saline, Rocephin, Levaquin, Benadryl, Tylenol and Solu-Medrol. Annual follow up on 02/04/04: It is unknown if the pt recovered from the adverse events.  We have ad no further communication with this pt. Discharge summary states dyspnea, pneumonia, wheezing, anxiety, increased drug effect, weak, chest pain. msv				Y	Y				U	11/04/2002	11/05/2002	1	Chest x-ray in ER indicated R lower lobe infiltrate Discharge summary states leukocytosis, bacterial infection. msv	PUB	PVT		Bronchitis	COPD, asthma, tobaccoism Discharge summary states depression, panic attack. msv			1						1	Anxiety; Asthenia; Bacterial infection; Chest pain; Drug effect increased; Dyspnoea; Injection site erythema; Injection site oedema; Leukocytosis; Pneumonia; Pyrexia; Wheezing	FLU3~SANOFI PASTEUR~U0946AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0172M~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0195651	12/31/2002		33.0	33		F		A report was received from a health care professional on 12/17/02 concerning a 32 year old female vaccinee who experienced serum sickness one day after receiving Fluvirin on 11/15/02. It was reported that the vaccinee had received an influenza vaccine for the past five years with the date of last vaccination reported as 2001. Concomitant medication reported included unspecified birth control pills. On the 11/16/02 the vaccinee developed hives and was treated with methylpredinisolone for seven days with improvement. After treatment with methylprednisolone was complete on approximately 11/23/02 the hives returned and the vaccinee was treated with prednisone (dose unk). On 12/6/02 the vaccinee began to experience swelling in the ankles, knees and shoulders and experienced a fever (temp unk). On 12/6/02 the vaccinee was hospitalized where the attending physician diagnosed serum sickness. The vaccinee was treated with unspecified IV steroids, methylprednisolone and ciprofloscin for five days. The vaccinee was discharged from hospital on 12/8/02. It was reported that the symptoms had improved but had not resolved. The reporter has assessed the relationship of the vaccine to the event as probable.   Follow up on 02/27/2003: A report was received from a health care professional which stated that the vaccinee had also experienced wrist swelling and had a fever of 101C approximately 2 weeks following vaccination.  The vaccinee had recovered at the time of the report.					Y				U	11/15/2002	11/16/2002	1		UNK	UNK	Contraceptive pills (unspecified)				PJP200200891	1						1	Joint swelling; Pyrexia; Serum sickness; Urticaria	FLU3~EVANS VACCINES~E31902HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0195653	12/31/2002	IN	56.0	55		M	11/05/2002	Left deltoid immediately swelled once flu vaccine was administered. Ice pack given. (Pt) said he was okay and insisted on returning to his desk									Y	11/05/2002	11/05/2002	0		OTH	UNK			NONE			1						1	Injection site swelling	FLU3~SANOFI PASTEUR~UO935AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195654	12/31/2002	IN	46.0	46		F		after injection of influenza vaccine into leftdeltoid, immediate swelling occurred. Ice pack again									Y	11/01/2002	11/01/2002	0		OTH	UNK			NONE	Topical redness~Influenza (Seasonal) (no brand name)~~21.00~Patient		1						1	Injection site swelling	FLU3~SANOFI PASTEUR~UO935BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195655	12/31/2002	IN	44.0	44		M		Right deltoid immediately swelled once flu vaccine was administered. Ice pack applied.										11/08/2002	11/08/2002	0		UNK	UNK			PCN			1						1	Injection site swelling	FLU3~SANOFI PASTEUR~UO935BA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195656	12/31/2002	IN	45.0	45		F		right deltoid immediately swelled once flu vaccine was administered. ice pack given/applied. (The pt) released to go home. Swelling reduced.										11/19/2002	11/19/2002	0		OTH	UNK			NKA			1						1	Injection site swelling	FLU3~SANOFI PASTEUR~UO935BA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195657	12/31/2002	IN	49.0	49		M		After injection of influenza vaccine into the left deltoid, imnmediate swelling occurred. Ice pack given										11/08/2002	11/08/2002	0		OTH	UNK			Cherries			1						1	Injection site swelling	FLU3~SANOFI PASTEUR~UO935BA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195658	12/31/2002	IN	33.0	33		F		1;25 pm left deltoid small amount of swelling noted hardened area around swelling. Bruise noted 3:45 pm, swelling reduced area not as hardened.										11/06/2002	11/06/2002	0		OTH	UNK			Aspirin			1						1	Injection site induration; Injection site swelling	FLU3~SANOFI PASTEUR~UO935BA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195659	12/31/2002	MN	39.0	39		F	11/15/2002	11/15/02 09:45 AM: Client called in with c/o nausea + hot flashes, Stated she just did not feel good. 11:00 AM: Did leave work early + went to her mom's house because client was not feeling well + did not want to drive home to Nassau, States went home later that evening + was feeling somewhat better, 11/15/02: States is doing fine now									Y	11/14/2002	11/15/2002	1		PUB	PUB	Effexor, Synthroid, Nortriptalin		Amoxiciliin, Keflex			1						1	Hot flush; Malaise; Nausea	FLU3~PFIZER\WYETH~4020023~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0195660	12/31/2002	FL	68.0	68		F	12/20/2002	Small many petechiae in 1/3 inferior of the legs  X 3 days									N	12/17/2002	12/18/2002	1	NONE	UNK	UNK		H.B.P.-O.A, Gastritis, (?)	PCN/Sulfa/Tetrcycline			1						1	Petechiae	FLU3~EVANS VACCINES~E3390216A~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0195661	12/31/2002	TX	44.0	44		F	11/01/2002	Pain at injection site, 50 cent size, pink + hot. Pain down arm up back of neck, Ice park topically, Declines Benadryl makes her drowsy. 11/01/2002  client out wk, States went home, took Benadryl,  Red area did not not increased in size. Tired with soreness in neck & arm.									Y	10/30/2002	10/30/2002	0		PUB	OTH	Effexor + Lipitor	NONE	NONE			1						1	Fatigue; Injection site pain; Injection site warmth; Neck pain; Skin discolouration	FLU3~SANOFI PASTEUR~UO913AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195662	12/31/2002	IL	40.0	40		F	12/24/2002	Had vaccine 10/28, 3:15pm. On 10/29/02 late in day noticed site hot and tender, no redness or fever. Also had pain into neck and numbness in right arm. Saw MD who prescribed antibiotic - Amoxiclau 875mg BID and Meclizine 12.5mg TIO. Began to feel better after 2 doses of antibiotic. 11/1/02 stated everything ok.				Y					Y	10/28/2002	10/29/2002	1	X-ray of chest and neck; Bloodwork	PVT	PVT	NONE	NONE	NONE			1						1	Neck pain; Paraesthesia; Vasodilation procedure	FLU3~EVANS VACCINES~E35732HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0195663	12/31/2002	IL		55		F	12/24/2002	11/21/02 sudden onset of n/v, chills, muscle ache, HA, fatigue. 11/22/02 felling much better. Does not intend to seek medical attention.									Y	11/21/2002	11/21/2002	0	NONE	OTH	PVT	Atenolol 50mg	NONE	Hypertension			1						1	Chills; Fatigue; Headache; Myalgia	FLU3~EVANS VACCINES~E33502HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0195664	12/31/2002	IN	62.0			F	10/29/2002	Noticed right arm red after taking band aid off today. Received flu vaccine yesterday. No pain. Right arm feels warm and hard lumps present.									U		10/29/2002			OTH	OTH		NONE				1						1	Vasodilation procedure	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0195678	12/31/2002	CA	4.0	4		M	12/23/2002	Left arm with erythema, edematous, warm to touch from axilla level to 3/4/ or arm.				Y					U	12/18/2002	12/20/2002	2		PVT	PVT	PPD		Asthma			1						1	Injection site erythema; Injection site oedema; Injection site warmth	DTAP~SANOFI PASTEUR~C0948AA~5~~RA~DTAP (DAPTACEL)~1|FLU3~PFIZER\WYETH~4020057~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|IPV~SANOFI PASTEUR~U1234~4~~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0771U~4~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0195692	12/31/2002		82.0	82		F		A report was received from a health care professional on 12/17/02 concerning a 82 year old female vaccinee who experienced slurred speech, increased saliva production, and was unable to lift her arm 20 minutes after receiving Fluvirin and required treatment in the ER on 11/18/02. The event was considered medically significant (OMIC). Concomitant medication reported included digoxin, thyroxine sodium, liothyronine sodium, doxepin hydrochloride, klonopin, zolpidem tartrate and trazodone hydrochloride. It was reported that the vaccinee had also received virus influenza (brand unspecified) on 11/1/02. The pt has a history of lung cancer, hypothyroidism, polyarthralgia, incomplete right bundle branch block and mild mitral valve regurgitation. On 11/15/02 the vaccinee experienced symptoms which the reporter felt were consistent with cerebral vascular accident (CVA). Symptoms reported included slurred speech, increrased soliva production and episodes whereby the vaccinee was unable to lift her arm. It was also reported that the vaccinee did not experience a rash, itching or throat tightening. The vaccinee was referred to a hospital ER on the 11/16/02 in order to rule out a CVA as per the reporter. It was reported that the vaccinee underwent a normal neurological examination in the ER of the hospital. It was reported that the vaccinee had recovered at the time of the report. The reporter has assesed the relationship of the vaccine to the event as unclassified.  Follow up on 01/29/2003: A follow up report was received from a health care professional.  The vaccinee received a 0.25ml Fluvizin booster intramuscularly into the left deltoid.  Additional concomitant medication reported included vezopomil, nystatin, testostelone, progesterone, vitamin B12, and sortesline.  The vaccinee has a past medical history of lung caner which began in 1967, incomplete right bundle branch block, lone paroxysmal atrial fibrillation, chronic fatigue, fibromyalgia, immune deficiency, valve regurgitation, insomnia, depression and hypertension.  The vaccinee has an allergy to penicillin and other medications.  The vaccinee also had mild tricuspid valve regurgatation (previously reported as mitral).  The vaccinee requested to receive a flu vaccine in a divided dose, 2 weeks apart.  The vaccinee initially received 0.25ml influenza virus (brand unspecified) on 10/31/2002 followed by a booster of 0.25ml flovirin on 11/15/2002. The vaccines was admitted to an emergency room with acute onset of slurred speech and a thick tongue approximately five minutes after vaccination.  The vaccinee denied any other acute complaints.  Upon physical examination the vaccinee had blood pressure of 126/61mm/Hg and a pulse of 81 beats/minutes.  The vaccinee was also reported to be anxious.  There were no cartid bruits and coronae examination indicated a regular rate and rhythm without any murmurs.  Neurological examination indicated all granial nerves through to MII were intact with the exeption of some very slight dysphasis.  The vaccinee's gait was within normal limits.  Fromberg test was reported as negative.  the vaccinee's electrocardiogram indicated normal sinus rhythem at 68 beats per minute with left atrial enlargement and an incomplete right bundle branch block.  This was reported as unchanged from a previous electrocardiogram taken on 03/19/2001, CBC, Coagulation, CPK and treponin I were all reported as normal.  Digoxin was reported to be in the therapeutic range.  The reporter assessed the speech difficulties to be of unclear etiology.  The reporter indicated that the vaccinee was instructed to continue her current medications no previously prescribed and to follow up with her PCP.  The vaccinee was discharged from hospital on 11/18/2002.  The reporter assessed the causal relationship of the event to fluvirin for saliva production, slurred speech, and inability to lift arm as possibly related, and impaired gait as unclassifiable.  The other event's causality were not reported.									Y	11/15/2002	11/15/2002	0	Blood pressure: 126/61mmHg; CBC: Normal; Coagulation: Normal; CPK: Normal; Electrocardiogram: NRep; Trofonin I: Normal;	UNK	UNK	Lanoxin, T4, Liothyronine sodium, Doxepin, Klonopin, Ambien, Trazodone		The pt has a history of lung cancer, hypothyroidism, polyarthralgia, incomplete right bundle branch block and mild mitral valve regurgitation.		PHP200200892	1						1	Cerebrovascular accident; Dysarthria; Joint range of motion decreased; Salivary hypersecretion	FLU3~EVANS VACCINES~E33402HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0195742	12/31/2002	CA	47.0	47		M	12/31/2002	Within 2-3 days of vaccination the soreness at the administration site in my right arm was gone, but I began to feel pain in my right elbow when lifting objects.  Also, within 3 weeks I developed a prostate infection (I don't know if this is related to the vaccination, but it also a strange coincidence, if it is not).  The manufacturer of the influenza vaccination is Adventis, Lot #UO938AA.				Y					N	11/13/2002	11/15/2002	2	Urinanlysis- test for infection from prostate.  Blood found in urine by urologist.  Have not had arm examined.	UNK	UNK	n/a	None	None			1						1	Infection; Pain	FLUX~UNKNOWN MANUFACTURER~U0938AA~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0195743	12/31/2002	GA	1.15	1	.2	F	12/31/2002	My daughter's pediatrician does not believe that the flu vaccine caused my daughter's seizures, which occurred 14 days after the vaccine was given, approx. on 11/15/02 at 10:30am. My daughter was perfectly healthy with no colds or illness prior to the flu shot being given. 14 days later we have been in and out of the hospital(s) with her seizures and have had tests including: Catscan, spinal tap, EEG, and an MRI run at the hospital, where they could find no cause for the seizures. There is no family history of epilepsy or seizures on either parent's side. My daughter has stopped breathing for 5 mins. with her first seizure in which I called 9-1-1 and she was taken by ambulance to the Medical Center and released that afternoon. She returned home, had more seizures and was taken to The Hospital where she stayed 5 days.  She has since had to ride in an ambulance due to the seizure two more times.  She is on a very high dose of Phenabarbitol for her seizures and is still having trouble controlling them. I would like this to be investigated because I feel that the flu shot may have caused the seizures, because she did not have them before. Medical record states shaking, limp, mental retardation, irritable. msv			Y	Y	Y	7			N	11/01/2002	11/15/2002	14	Medical record states abnormal EEG. msv	UNK	UNK						1						1	Convulsion; Electroencephalogram abnormal; Hypokinesia; Mental retardation severity unspecified; Nervousness; Tremor	FLU3~PFIZER\WYETH~4020017~1~SC~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0195704	01/02/2003	NY	62.0	61		M	12/19/2002	Patient developed right subconjuctival hemorrhage 3 hours after receiving vaccine. Patient reportedly received no other medication prior to event. Patient was given artificial tears to keep eyes moist. 60 day follwow up states assume yes that pt has recovered.								Y		11/25/2002	11/25/2002	0	Patient was told to report to eye clinic for evaluation on 11/27/02 but lost to follow up.	UNK	UNK	NONE		Hearing loss October 2002. Otherwise reportedly healthy male. No allergies reported. Social history unavailable.			1						1	Conjunctival haemorrhage	FLU3~SANOFI PASTEUR~40956AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0195712	01/02/2003	WI	39.0	39		F		Redness, edema on both injection sites.									Y	12/16/2002	12/17/2002	1	NONE	PUB	PVT	Effexor, Advair, Singular, Accupril		PCN; Sulfa; Emycin; Tetracycline			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U0926OA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0111M~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0195713	01/02/2003	GA	37.0	37		F	12/18/2002	Received flu shot 11/7/02 during shot clinic. Developed decreased range of motion. No swelling. Saw doctor 12/9/02 X-ray was done. Celebrex was prescribed. Saw doctor again on 12/11/02. Has completed Celebrex; still having soreness in right shoulder.				Y					U	11/07/2002	11/07/2002	0	X-ray left shoulder 12/9/02.	PUB	PUB	NONE	NONE	NONE		GA02132	1						1	Joint range of motion decreased; Myalgia; Shoulder pain	FLU3~PFIZER\WYETH~4020033~6~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0195714	01/02/2003	OR	32.0	32		F	12/03/2002	Patient received flu vaccine and about 7 minutes later, she complained of blurred vision, dizziness, and tight chest. EMS was called. NP was 104/88, Pulse 80. EMS arrived and assessed patient at about 16:12. Patient was feeling better; believed she was having an anxiety attack. Patient stated all symptoms were gone. She signed a consent to refuse transport. Patient was released to her husband, a deputy sheriff.									Y	12/03/2002	12/03/2002	0		PUB	PUB		NONE	Asthma, Anxiety		OR200246	1						1	Chest discomfort; Dizziness; Vision blurred	FLU3~PFIZER\WYETH~4020024~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0195715	01/02/2003	CA	50.0	49		F	02/21/2003	I woke up the next morning with cold sweats, nauseated, very weak feeling. Lasting until the morning of 12/6/02.									Y	12/04/2002	12/05/2002	1		UNK	OTH	Acyclovir	NONE				1						1	Asthenia; Hyperhidrosis; Nausea	FLU3~PFIZER\WYETH~4020034~2~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0195734	01/02/2003	MA	42.0	42		F	12/24/2002	Developed generalized itching two hours after receiving fluzone. Notified employee health at 4:30pm. Benadryl 25mg ordered. Asumptematic on 11/5/02.				Y					Y	11/04/2002	11/04/2002	0		UNK	PUB						1						1	Pruritus	FLU3~SANOFI PASTEUR~U0949AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0195741	01/02/2003	SD	25.0			F	12/31/2002	Severe low abdominal pain; weak, blacked out, sat down. Seen in ER. Rx painkillers.				Y					Y					UNK	UNK	Orthotricycline	NONE	NONE			1						1	Abdominal pain lower; Asthenia; Loss of consciousness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0195476	01/03/2003	CA	3.0	3		F	12/31/2002	A medical assistant reported that a 3 year old female received Flu Shield on 12/9/02. The infant developed Guillain Barre syndrome and was hospitalized for approximately 10 days. No additional info was available as of the date of this report. This report of a serious labeled event is being submitted in a 15 day time fram as requested by the FDA. Follow up info received 1/14/03 from physician provided ptdetails, description of course of illness, hospitalization dates, treatment, and discharge diagnosis. A medical assistant reported that a 3 year old feamle received Flu Shield/2002-2003 formula on 12/9/02. Medical history includes birth by caesarean section and apnea. On 12/11/02, she returned to the office with abdominal pain and vomiting and difficulty having a bowel movement. While examining the child it was noticed that her legs were limp, with no strength or movement. It was decided for her to go to the ER. On 12/12/02, she was admitted to the hospital for further evaluation of the condition and for possible Guillain-Barre syndrome. She also has been unable to urinate and cannot walk. The neurological exam was essentially negative except for the deep tendon reflexes which are 3+ and Babinski is negative. Lab tests include a blood culture (negative), urine culture (positive organism not specified) and a renal ultrasound (positive). She was diagnosed with a urianry tract infection and treated with Bactrim. On 12/19/02, she was discharged from the hospital. The discharge diagnosis was BGS 2 hr. to Flu vaccination, Lower Ext., UTI. The discharge instructions provide for physical therapy 3x per week for 3 weeks, then the pt will be re-evaluated. This report of a serious labeled event is being submitted in a 15-day time frame as requested by the FDA.				Y	Y	6			U	12/09/2002	12/09/2002	0	The neurological exam was essentially negative except for the deep tendon reflexes which are 3+ and Babinski is negative. Lab tests include a blood culture (negative), urine culture (positive organism not specified) and a renal ultrasound (positive).	PVT	PVT	NONE	UNK	Apnoea		HQ5911526DEC2002	1						2	Abasia; Abdominal pain; Gastrointestinal disorder; Guillain-Barre syndrome; Laboratory test abnormal; Urinary tract infection; Vomiting	FLU3~PFIZER\WYETH~4020034~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Hospitalisation	Influenza
0195749	01/03/2003	IA	0.67	0	.7	M	12/02/2002	Paralysis affecting left arm, leg and facial features. Hospitalized after Dr's office visit on 11/11/02. Parents told two blood clots in brain. Treatment-physical therapy one baby aspirin daily. Diagnosed with opening between atria of heart. Being treated for mitochondrial defect and blood clotting disorders. In process of recovery. On 60-day followup report received 04/25/2003, reporter states, Patient was tested at facility after Vx and they found a hole in his heart and said it was not Vx-related. Pt is going back to facility in 5 months to see if hole in heart has closed.  Annual follow up on 04/21/04: Pt has recovered from adverse event.				Y	Y				Y	11/07/2002	11/11/2002	4	MRI x2; Echocardiogram EKG's x2; Numerous blood tests.	PUB	PUB		NONE	NONE		IL02067	1						1	Paralysis; Thrombosis	FLU3~SANOFI PASTEUR~U0946AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0195751	01/03/2003			68		F	10/21/2002	Pr received a Pneumovax & flu injection during her office visit.  Pt states that 6 hours after receiving the  injection,she presented with sx - chills, sweats, lowgrafe fever, nausea, arm pain, localized redness and swelling @ injection site, Also c/o some left sided joint pain (arm & knee), Poor appetite Sx: resolved in approx 3 days.				Y					Y	10/17/2002	10/17/2002	0	NONE	UNK	UNK			Pt is allergic to Motrin& Sulfamethox & IVP Dye, History of benign Htn, Diverticulosis, Mitral valve prolapse, Hyperlipedmia			1						1	Arthralgia; Chills; Hyperhidrosis; Injection site erythema; Injection site pain; Injection site swelling; Nausea; Pyrexia; Chills; Hyperhidrosis; Injection site erythema; Injection site oedema; Pain; Pyrexia	FLU3~SANOFI PASTEUR~UO968AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1264L~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~1264L~1~~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0195752	01/03/2003	OH		22		F	12/27/2002	Developed HA, nausea, about 9:30 pm same day as vaccine. Vomiting started 10:45 am Friday 11/22/02 went to emergenv room that  evening, Seen by family physician doctor, Sunday 11/24/02 diarrhea lasting one day, Symptoms subsided Monday				Y					Y	11/22/2002	11/22/2002	0		OTH	PVT		NONE Known	Leukemia, as child, Has been in remission > 5 yrs			1						1	Diarrhoea; Headache; Nausea; Vomiting	FLU3~SANOFI PASTEUR~UO881AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0195753	01/03/2003	CA	55.0	55		M	12/29/2002	Loss of equilibrium,ringing in the ears, pain in right eye and in right side of brain, sensation of bubbles in my right ankle,, mild chest, heart papitation, gritty grinding noise like sand in my neck joint when I turn my head									Y	11/20/2002	11/20/2002	0	No tests done	UNK	PVT	(NONE taken on that day)		Redness of eyes, Aspergers Syndrome, hearing voices			1						1	Arthropathy; Balance disorder; Eye pain; Heart rate increased; Injection site pain; Tinnitus	FLU3~SANOFI PASTEUR~V0919AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195754	01/03/2003	OR	52.0	52		F	12/30/2002	Flu vaccine  given  8-9 am on 11/07/02 15 mins later- HA,Vertigo,nausea, ''cold sweats + advancing edema of hand on arm , 15 mins after above vomiting,very unsteady on feet, Sent to hospital ER				Y					Y	11/07/2002	11/07/2002	0		OTH	PVT	Protonix, Monopril 40mg	NONE	High B/P, Allergies, Codeine, Hydrocodone			1						1	Balance disorder; Feeling cold; Headache; Hyperhidrosis; Nausea; Oedema peripheral; Vertigo; Vomiting	FLU3~SANOFI PASTEUR~UO981AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0195765	01/03/2003	ND	22.0	22		F	01/03/2003	Pt developed fever of 102 with swelling in Left arm 3 by 3 inches. Was on her way to London mother called on 1-2-03 with report and swelling increasing saw Dr in airport and was given Benadryl.Mother called this am and pt arm swollen to elbow now and is seeing a physician in another country.				Y					U	12/30/2002	12/31/2002	1	None known	PUB	PVT	Alesse Lexapro	None	Depression Allergy to Cephalexin			1						1	Oedema; Pyrexia	FLU3~EVANS VACCINES~E33162GA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0873M~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0195795	01/03/2003	SC	60.0	60		M	01/03/2003	PATIENT RETURNED TO OUR OFFICE TODAY WITH REDNESS & SWELLING AT INJECTION SITE. ALSO COMPLAINED OF EXTREME NECK AND SHOULDER PAIN. NSAID,ANTISPASMOTIC,STERIOD GIVEN IN OFFICE TODAY				Y					U	12/31/2002	01/01/2003	1		PVT	PUB	PRAVACHOL,ATENOLOL,ASA,LISINOPRIL,  HYZAAR		HYPERTENSION,HYPERCHOLESTEROLIMIA, SPASTIC PARAPLEGIA,OBESITY			1						1	Erythema; Injection site oedema; Pain	FLU3~PFIZER\WYETH~4020027~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0195771	01/06/2003	MA	59.0	59		F	12/27/2002	Pain swelling induration at injection site diagnosed as cellultiis. Negative blood cultures temp 100 deg-101.8 deg F. Clinically toxic. Treated with IV Kefzol. Discharged on Augmentin. The discharge summary states chills, anorexia, nausea, and pain.					Y	3			Y	11/25/2002	11/26/2002	1	WBC 34,300; 80 polys, 10 bands	PVT	PVT	Fosamax 70mg weekly, Paxil 30mg po qd		Wellbutrin, depression			1						1	Anorexia; Cellulitis; Chills; Injection site induration; Injection site oedema; Injection site pain; Nausea; Pain; Pyrexia; White blood cell count increased	FLU3~SANOFI PASTEUR~U0932DA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0195772	01/06/2003	WI	50.0	50		F	12/30/2002	Low grade fever, pain. Shot received on 11/4/02. On 11/11/02 shot boosted immune system. Could not use arm, shoulder shot was given in. MD removed fluid-? of infection. Had arthroscopic surgery on 11/14/02-surgeon MD. Still has pain from shoulder.				Y	Y	5			Y	11/04/2002	11/11/2002	7	WBC 19.6, no bacteria from site on 11/13/02; WBC increased 150,000.	PVT	OTH	Synthroid, prednisone, Methotryal	Rheumatoid arthritis	Thyroid removal, Skin Folliculitis			1						1	Hypokinesia; Infection; Pain; Pyrexia; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~6~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0195775	01/06/2003	ME	12.0	12		M	12/27/2002	Left shoulder swelling, redness, tenderness, nausea, malaise, fever to 102. Treated with IV and PO antibiotics as cellulitis both complete improvement.				Y					Y	12/18/2002	12/20/2002	2	CBC, Blood culture, Throat culture,	PVT	PUB	Albuterol, Singulair, Flovent, Immunotrigger	NONE	Asthma, Allergies			1						1	Cellulitis; Malaise; Nausea; Oedema; Pyrexia; Tenderness; Vasodilation procedure	FLU3~SANOFI PASTEUR~V09524A~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0111M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0195779	01/06/2003	IL	73.0	74		F	12/25/2002	Patient was given pneumococcal vaccine 11/22/02. Patient stated after leaving the office she experieince a red itchy rash and bumps. Area affected was chest, back and both arms. Patient did not report this adverse reaction until a month later. Patient felling better. Rash is clearing.									Y	11/22/2002	11/22/2002	0		UNK	UNK			IDDM, HBP, Angina			1						1	Rash maculo-papular	FLU3~EVANS VACCINES~E33902HA~2~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0955M~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0195782	01/06/2003	FL		1	.0	M		Broke out in chicken pox.				Y					Y	12/10/2002	12/29/2002	19		PVT	PVT						1						1	Infection	FLU3~SANOFI PASTEUR~U0954AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0202M~1~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0813M~1~~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0195872	01/06/2003	IA	82.0	82		F	01/06/2003	PATIENT'S WHOLE BODY STARTED ITCHING THE MORNING AFTER RECEIVING HER FLU SHOT									Y	11/12/2002	11/13/2002	1	N/A	UNK	PVT	UNKNOWN	NONE PER PATIENT'S DAUGHTER	NONE			1						1	Pruritus	FLU3~PFIZER\WYETH~4020024~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0195810	01/07/2003	IL	74.0	74		F	12/23/2002	Pt states she awakened morning after getting flu shot with tightness in chest, severe headache and chills for 2 days. Breathing difficulties persisted over the next 30 days. Hospitalized 12/14.				Y	Y	5			Y	10/22/2002	10/23/2002	1	Nuclear lung scan to r/o blood clot in lungs. Cardiac consult to r/o cardiac cause multiple labs drawn.	PVT	PUB	Thyroid, BP medicine, Water pill, Potassium, Advair	Under extreme stress	Hypothyroidism; Asthma; History of CABG x3		IL02068	1						1	Chest discomfort; Chills; Dyspnoea; Headache	FLU3~SANOFI PASTEUR~U0888AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0195813	01/07/2003	NY	49.0	49		F	12/31/2002	3 days after vaccine administered, patient had severe flu like illness with severe headache; 3 days (72 hours) after vaccination. Patient developed herpes zoster of right forehead and scalp.  Reported on 04/03/2003 (Discharge Summary): Preorbital cellulitis until recently herpes zoster on her right forehead.  Final Diagnosis: Pre-orbital cellulitis and herpez zoster with balour SLE.  Medications: Atovea: 25mg prn; Predmisor 30mg; Lennar 500mg; Pralain 40mg; Bactraboul 2% oint.  Patient had fever, chills, mild headache, shortness of breath, abdominal pain, nausea, vomiting.					Y	2			Y	11/20/2002	11/22/2002	2		PVT	PVT	Prednisone, Cell-cept	Bullous lupus erythema	Bullous Lupus Erythematosis			1						1	Abdominal pain; Chills; Dyspnoea; Headache; Herpes zoster; Influenza like illness; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U0937AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0195816	01/07/2003	TX	28.0	28		F	12/09/2002	Rash--both arms, chest, both legs, red face. Neck and face felt like it was on fire; itchy. Taking Benadryl.									Y	12/06/2002	12/06/2002	0		OTH	PUB	Advair	NONE	Chronic bronchitis		TX02140	1						1	Flushing; Pruritus; Rash	FLU3~SANOFI PASTEUR~U0922AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0526M~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0195817	01/07/2003	TX	56.0	56		F	12/09/2002	Rash on right arm above wrist; 2.5 inch area, blotchy.									Y	12/04/2002	12/09/2002	5		OTH	PUB	Clarinex, Zocor, Nasocort, Lisinopril, Albuterol, Ultracet, Zelnorm, Dicyclomine, Doxepin, Estratab		IBS; Botox treatment on back		TX02139	1						1	Rash; Rash macular	FLU3~SANOFI PASTEUR~U0922AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195821	01/07/2003	IL	51.0	51		M	12/27/2002	Heart rate increase, chills, upset stomach, weak.									Y	12/02/2002	12/02/2002	0		PUB	PVT		NONE	Heart problem			1						1	Asthenia; Chills; Heart rate increased; Stomach discomfort	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0195824	01/07/2003	MA	24.0	24		F	12/13/2002	I received a flu shot. When I got the shot, my arm bled. I received a bump and a bruise. Soon after my shot, I received a large dark bruise and a welt. My arm hurt. 12/16/02 Patient saw both her school nurse and a physician. The physician saw the injury 3 days after the shot. His diagnosis was that her arm was infected, but that the antibiotics she was already taking probably helped with the arm infection.									Y	12/03/2002				PUB	PUB	Pill antibiotic, Zoldot	NONE	Allergies			1						1	Contusion; Injection site infection; Pain; Urticaria	FLU3~SANOFI PASTEUR~U0879AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195826	01/07/2003	PA	32.0	32		F	01/22/2002	09:45 Patient complained of left side of face feeling tingly, ear felt clogged; stated she didn't have this before; BP 128/80, Pulse 88. 10:45 No change; BP 130/78 and P 74. 11:30 Patient stabilized. I feel better; referred to family doctor. 11:45 I feel like it is resolving; only arms have a little tingling.									Y	11/19/2002	11/19/2002	0	NONE	PUB	UNK	NONE	NONE	NONE		PA0301	1						1	Ear discomfort; Heart rate increased; Paraesthesia	FLU3~PFIZER\WYETH~4020026~UNK~~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0195827	01/07/2003	PA	62.0	62		M	11/20/2002	Within 30 minutes developed firm red rash, chest, neck. By afternoon, rash became raised with vesicles. Temp 102.4, joint aches and nausea. Saw MD late that afternoon who Dx'd adverse reaction to immunization. Rx'd medrol dose pack and Benadryl. Rash markedly improved after treatment, fever, aches improved 11/19/02. Pt developed urinary retention, thought by family physician to be related to Benadryl.				Y					N	11/18/2002	11/18/2002	0	NONE	PUB	PUB	Naciolol, HCTZ, baby aspirin	NONE	Hypertension		PA0303	1						1	Arthralgia; Blister; Nausea; Pyrexia; Rash erythematous; Urinary retention	FLU3~SANOFI PASTEUR~U0943AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0195830	01/07/2003	IL	76.0	76		F	10/24/2002	Localized swelling at injection site. Cool to touch. Client denies any SOB, itchy or pain.									Y	10/24/2002	10/24/2002	0		OTH	PUB	UNK				IL02070	1						1	Injection site swelling	FLU3~PFIZER\WYETH~40200022~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0195831	01/07/2003	MN	1.3	1	.4	F	12/31/2002	DTaP-HIB and Flu shot #2 (booster) in left thigh 12/30/02. Awoke 12/31/02 with red, swollen thigh; erythema 5x6 and swelling. Circumference of left thigh 2 larger than right thigh. Walking well and afebrile. Not acting ill.									Y	12/30/2002	12/31/2002	1		PVT	PVT	Poly-vi-sol	NONE	NONE			1						1	Injection site erythema; Injection site swelling	DTAP~SANOFI PASTEUR~U0585DB~4~~LL~DTAP (TRIPEDIA)~1|FLU3~PFIZER\WYETH~4020037~2~~LL~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|HIBV~SANOFI PASTEUR~UA736AA~4~~LL~HIB (ACTHIB)~1	USA		Influenza
0195900	01/08/2003	MA		72		F		Case's palms and soles of feet became very itchy on 10/21/02. Several hours later her arms became itchy and blotchy. Went to dermatologist. No food eaten that may have caused itch and rash. MD suggested it was flu shot. Benadryl and Allegra prescribed									Y	10/17/2002	12/21/2002	65		PUB	PUB	Diovan, Lopressor	Mild cold symptoms	UNK			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U0879AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195901	01/08/2003	IA	62.0	62		F	11/19/2002	Patient reports that she developed anxiety 3 days after receiving influenza vaccine at store clinic. Was seen by her physician - began on buspirone 10/29/02. Anxiety not improving and seen by physician 11/18 and dosage increased. Patient states has had short, mild episodes of anxiety in past - no treatment required.				Y					U	10/22/2002	10/25/2002	3		OTH	OTH			Chronic cough - etiology UNK			1						1	Anxiety	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0195902	01/08/2003	SD	31.0	31		F	11/09/2002	Numbness and tingling occurred in upper left arm within a few minutes. Approximately 5-10 minutes later had swelling in whole let arm, wrist and hand. States numbness and tingling progressed through whole arm. On 11-11-02 she returned to EHS states all symptoms have resolved.				Y					Y	11/09/2002	11/09/2002	0		PVT	OTH	NONE	NONE	NONE			1						1	Oedema; Paraesthesia	FLU3~SANOFI PASTEUR~U0954AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0195903	01/08/2003	KS				M	12/12/2002	A physician reported that a male patient in his forties received an injection of Flu Shield (2002-2003 Formula) on 10/30/02. When he received the injection, he immediately felt a burning sensation described as feeling like a hot poker. Within 3 days, his arm was throbbing and advanced to shoulder pain. As of 11/26/02, the patient had severe shoulder pain with limited range of motion, 45 degrees flexion and 45 degrees abduction. He has no cross body pain; however, he experiences knifelike pain in his anterior and top shoulder. The pain has gotten worse over time. This is 1 of 3 patients from this facility who developed pain at the injection site following administration of lot 4020029. The reporter noted that they suspected lot 4020029 was administered, but were not sure. This lot was the product in the office as of 11/29/02. See related HQ5549927NOV2002 and HQ550627NOV2002.									U	10/30/2002	10/30/2002	0	UNK	PVT	PVT	UNK	UNK	UNK		HQ5549427NOV2002	1						1	Joint range of motion decreased; Shoulder pain; Thermal burn	FLU3~PFIZER\WYETH~4020029~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0195904	01/08/2003	KS				F	12/12/2002	A physician reported that a female patient in her twenties received an injection of Flu Shield (2002-2003 formula) (influenza virus vaccine, trivalent, types a & b) on 11/1/02. The patient's mother contacted the physician's office to report the patient was experiencing arm pain that had started since she received the injection. She was seen on 11/18/02 and she was noted to have difficulty with range of motion. She could move her arm back and forth, but experienced pain moving it laterally. This is 1 of 3 patient's from this facility who developed pain at the injection site following administration of lot 4020029. The reporter noted that they suspected lot 4020029 was administered, but were not sure. This lot was the product in the office as of 11/29/02. See related HQ5549427NOV2002 and HQ5549927NOV2002.				Y					U	11/01/2002	11/01/2002	0	UNK	OTH	OTH	UNK	UNK	UNK		HQ5550627NOV2002	1						1	Joint range of motion decreased; Pain	FLU3~PFIZER\WYETH~4020029~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0195905	01/08/2003	KS				F	12/12/2002	A physician reported that a female patient received an injection of Flu Shield (2002-2003 Formula) on 10/29/02. She subsequently developed pain in her shoulder and difficulty moving her arm 2 to 2.5 weeks after receiving the vaccine. She was instructed to see her primary physician who diagnosed her with bursitis. This is 1 of 3 patients from this facility who developed pain at the injection site following administration of lot 4020029. The reporter noted that they suspected lot 4020029 was administered, but were not sure. This lot was the product in the office as of 11/29/02. See related HQ5550627NOV2002 and HQ5549427NOV2002.				Y					U	10/29/2002	10/29/2002	0	UNK	PVT	PVT	UNK	UNK	UNK		HQ5549927NOV2002	1						1	Bursitis; Joint range of motion decreased; Shoulder pain	FLU3~PFIZER\WYETH~4020029~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0195906	01/08/2003	MD	65.0	65		F	12/30/2002	Shoulder pain, aching getting worse as time went on. Rash broke out approximately 22nd or 23rd then got much worse. Went to doctor on 26th was told it is shingles - given medication.				Y					U	12/17/2002	12/18/2002	1		PVT	PVT	Vitamins	NONE				1						1	Herpes zoster; Pain; Rash; Viral infection	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0195907	01/08/2003	MA	64.0	64		F	12/31/2002	12/17/2002 patient awoke in morning with bilateral shoulder pain, left greater than right, headache, neck pain and chest pressure. Left shoulder tender and swollen. Right shoulder also slightly swollen. Rx with ice paks and Tylenol. Feels better.				Y					Y	12/16/2002	12/17/2002	1	BP 129/63, P-100, RR-20, T-99, O2SAT 94%	PVT	PVT			Asthma, Hypothyroid, HTN, Hepatitis B, S/P CVA SVT; Allergy to PCN, E-mycin, sulfa, lovenox, codiene, NSAIDS			1						1	Chest pain; Headache; Oedema; Pain; Tenderness	FLU3~EVANS VACCINES~E35502KA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0358M~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0195908	01/08/2003	CA	44.0	44		F	12/18/2002	Fifteen minutes later began to pass out. Took Benadryl. Slept 12 hours. Two days later also dizzy while walking.									Y	12/11/2002	12/11/2002	0		PVT	PVT		NONE	Passed out during desensitization (allergy shots) needed adrenaline; Anaphylactic shock; Erithromycin, codeine, morphine, ceclor, cipro			1						1	Dizziness; Syncope	FLU3~SANOFI PASTEUR~U0949AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195909	01/08/2003	PA	33.0	33		F	01/02/2003	Patient states the left arm hurt badly the evening of 11/19/02. The left arm continued to be painful over the next month. She states the pain is in the joint, so that it hurts to lift her arm over the head, put on clothing. She phoned health dept on 12/19/2002 and was advised to see a physician.									U	11/19/2002	11/19/2002	0		OTH	PVT						1						1	Arthralgia; Pain	FLU3~SANOFI PASTEUR~U0909AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195941	01/08/2003	MA	77.0	77		F		3 X 4 red, painful, swelling. Temperature 100F.									Y	12/05/2002	12/06/2002	1	NONE	PVT	PUB	Effexor extended release; doxepin HCL; Tylenol 3; Propranolol; calcium; Levoxine; multivitamins; Ecasa (aspirin enteric coated); tamoxifen; lithium;	NONE	Depression; Hypothyroidism; heart murmur; tremor (essential); Melanoma on the forearm; OA of knees; Breast Cancer Stage IIA; Fungal fingernail infection; Acrodermatitis Continua of Hallopeau; SP Colle's FX from a fall; Spinal stenosis at 14-15, marked on MRI 8/01; Mastoid surgery; ankle fracture; OA ankle; lichen planus (mouth); hearing impairment; sleep apnea; peripheral neuropathy; breast biopsy; allergies to penicillins (facial swelling); Ultram (CNS); antihistamines (rash); Bactrim; NSAID's (rash); pneumovax (erythema, swelling at site of inj to elbow and slight fever of 100F.			1						1	Injection site erythema; Injection site pain; Injection site swelling; Pyrexia	FLU3~SANOFI PASTEUR~U0935BA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0710M~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0195985	01/08/2003	SC	18.0	18		M	01/08/2003	20 minutes after recieving vacinnes, patient fell onto padded matting with tachypneic respirations in apparent respiratory distress with hives only on forehead, awake and responsive with generalized twiching of upper extremities, C/O chest pain.  50mg Benadryl IM and 0.3mg Epinephrine IM given, place on O2 10L NRB.  Lungs with diffuse wheezes but moving air with patent airway.  Code Blue called, placed on monitor-NSR with sinus tach. Vitals 135/97, P-100, R-75, SAO2 99% NRB, with strong pulses. IV started.  Patient given 5 mg valium IVP and 5mg albuterol via HHN.  Taken to hospital ER via ACLS.  Admitted overnight for observation.  Discharged 1200 the following day.				Y	Y				Y	01/07/2003	01/07/2003	0	None significant	MIL	MIL	Tubersol (PPD)MFR-Aventis  LOT CO986AB placed left forearm at time of immunizations	None	worked with a cardiologist for 5 years to determine cause of 6 syncope episodes.  No resolution			1						1	Anaphylactic reaction; Chest pain; Muscle twitching; Respiratory distress; Tachycardia; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~UO957AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~SANOFI PASTEUR~UB211AA~1~SC~RA~MENINGOCOCCAL (MENOMUNE)~1|TTOX~SANOFI PASTEUR~UO528AA~2~IM~RA~TETANUS TOXOID, ADSORBED (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0196007	01/08/2003	NY	44.0	44		F	01/08/2003	Hot, erythematous, three inch diameter macular rash on area of vaccination (posterior deltoid of left arm).  She also had accompanying burning sensation along the ventral forearm and weakness in the hand.  All symptoms and signs resolved completely within four days.  She was treated with cold packs.  She refused benadryl P.O.									Y	01/03/2003	01/03/2003	0	None	MIL	MIL	None	None	None			1						1	Injection site erythema; Injection site inflammation; Injection site rash; Injection site warmth; Muscular weakness	FLU3~SANOFI PASTEUR~40956AA~7+~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195988	01/09/2003	MI	52.0	51		M	01/03/2003	Severe left shoulder and chest pain. Diagnosed as acute brachioplexitis 2 hours after flu shot. required IV, Dicandin and hospitalization for four days to control the pain and to rule out MI. Complete recovery after oral steroids and physical therapy one month later.				Y	Y	4			Y	10/09/2002	10/10/2002	1	Cervical and Left Brachioplexis, MRI	PVT	UNK	Hyzaar, Zocor, Prevacid, Avandia, ASA	NONE	HTN, Hypercholesterol, Diabetes Type II, RBBB, Allergic PCN			1						1	Chest pain; Shoulder pain	FLU3~EVANS VACCINES~E35722HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0195990	01/09/2003	OH	55.0	55		M	01/08/2003	The employee had his flu vaccine given on 10/21/2002. On 10/22/2002, he returned complainy of his arm being reddened, warm to touch, and swollen at injection site.									Y	10/21/2002	10/22/2002	1	NONE	PUB	OTH	NONE	NONE	Allergic to Sulfa			1						1	Feeling hot; Injection site erythema; Injection site oedema	FLU3~EVANS VACCINES~E33092HA~7+~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0195991	01/09/2003	OH	49.0	49		F	01/08/2003	On 11/01/2002 pt was given the flu vaccine. She returned on 11/04/2002 stating she developed a rashy red area at injection site. She denied pain and itchy. This disappeared within 2 days.									Y	11/01/2002	11/02/2002	1	PPD C1114AA left lower arm 3 doses 11/01/2002	PUB	OTH		NONE	NONE			1						1	Injection site erythema; Rash	FLU3~EVANS VACCINES~E33092HA~4~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0195992	01/09/2003	OH	67.0	67		M	12/30/2002	12/13/2002 Pt presented with MO after receiving flu shot 11/13/2002. C/O soreness in arm, espec. when he lifts it.  Note attached---12/13/2002 Client presented at health dept. Nurses were not present. client stated to secretary that his arm is still sore with flu shot on 11/13/2002, especially when lifting arm or to shave. States he applied warm compresses x 1 for 1 minutes. Advised to see PMD if continues. 12/13. I phoned pt's home. He was not available. Spoke with his wife. Re- interated that he should see his private physician; also that I would file a VAERS form. To call me back when he comes home.  12/30/2002 To date, no response from client. VAERS form filed.									U	11/13/2002	11/13/2002	0		PUB	PUB		NONE	NONE		OH0001	1						1	Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~U0925AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0195993	01/09/2003	PA	71.0	71		M	01/02/2003	Pt c/o only a slightly sore arm for 1-2 days after receiving vaccine. however, he c/o being  very tired and blisters and having no energy since receiving the vaccine. Pt was advised to consult his MD for advise. Pt states he is due for lab work and a check up.									U	11/26/2002	11/26/2002	0		PUB	PVT						1						1	Blister; Fatigue; Injection site pain	FLU3~EVANS VACCINES~E33142GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0196012	01/10/2003	NM	79.0	79		M	01/06/2003	Information has been received from a registered nurse concerning a 79 year old white male pt with cardiomyopathy, anemia and a penicillin allergy, and a history of congestive heart failure, skin cancer, and mylaogenous leukemia who on 10/29/02 at 13:30pm was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (643784/0676M) SC in the left arm. Concomitant vaccine therapy included an eighth dose of influenza virus vaccine (Fluzone lot U0883AA in the right arm). There were o adverse events following prior vaccinations. Other concomitant therapy included synthroid, Coreg, temazepan, allopurinol, hydralazine, ferrous sulfate and epostin alfa 60,000 untis every two weeks. On 10/31/02 at 9am, the pt developed redness, edema and heat over the left deltoid and pain at the injection site. The discolored area was reported to be 12cm x 29cm. A diagnosis of cellulitis was made. The pt was treated with Levaquin 500mg daily for seven days. The pt was to have been seen for follow up two days after the antibiotics were started. It was reported that on 11/2/02, the pt recovered. The pt's cellulitis was considered to be an other important medical event (OMIC). Additional info is not expected.				Y					Y	10/29/2002	10/31/2002	2		PVT	PVT	Synthroid, Coreg, temazepan, allopurinol, hydralazine, ferrous sulfate and epostin alfa	Anemia NOS; Penicillin allergy; Cardiomyopathy NOS	Cardiac failure congestive; Leukemia myelogenous; Skin cancer		WAES0211USA00182	1						1	Cellulitis; Injection site erythema; Injection site oedema; Injection site pain; Injection site reaction; Injection site warmth	FLU3~SANOFI PASTEUR~U0883AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0676M~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0196020	01/10/2003	CA	48.0	58		F	12/04/2002	Patient claimed having body malaise, not feel good and had been vomiting.				Y					U	12/03/2002	12/03/2002	0		PUB	PUB		Malaise, Vomiting	History of uterine fibrods, HRT		CA020104	1						1	Malaise; Vomiting	FLU3~SANOFI PASTEUR~U0920AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0196021	01/10/2003	IN	34.0	34		F	01/08/2003	Patient called our office on 1/5/03. Patient complained of rash that started on 1/4/03. Pat had flu vaccine on 1/3/03. Patient complained of pruritis and rash. Patient to take Benadryl. Patient denies other symptoms. Afebrile, no SOB.									Y	01/03/2003	01/04/2003	1	NONE	PVT	UNK	BCPs	NONE	UNK			1						1	Pruritus; Rash	FLU3~EVANS VACCINES~E33702HA~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0196022	01/10/2003	AR	8.0	8		M	01/06/2003	Multiple circular vesicular lesions on the arm that influenza vaccine was given. These lesions also had an impetigous component to them. Right axillary node also.									U	12/31/2002	01/01/2003	1	CBC - normal	PVT	PVT		NONE	Codeine			1						1	Dermatitis bullous	FLU3~EVANS VACCINES~E34692HA~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0196023	01/10/2003	CA	55.0	55		M	12/26/2002	Ringin in head - high pitched noise 17 days after flu vaccine.				Y					U	12/06/2002	12/23/2002	17		PUB	PUB					CA020102	1						1	Tinnitus	FLU3~SANOFI PASTEUR~U0919AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0196024	01/10/2003	NC	26.0	26		F	11/20/2002	Injection side sore night of injection and following morning with redness. On 11/19 noted soreness under left arm. 11/20 left lower axilla edematous and tender. Afebrile - Painful with movement. Saw MD on 12/20/02, advised Ibuprofen 200mg every 8 hours. Took Ibuprofen for 2 days. Swelling and redness gone in 2 days.				Y					Y	11/15/2002	11/19/2002	4	NONE	PUB	PUB	NONE	NONE	Allergic to Penicillin		NC02124	1						1	Hypokinesia; Injection site pain; Oedema; Pain	FLU3~PFIZER\WYETH~4020022~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0196025	01/10/2003	NY	51.0	61		F	01/03/2003	Patient developed right subconjunctival hemorrhage approximately 3 hours post vaccine. Patient given artificial tears and was told to follow-up with a visit to eye clinic.									U	11/25/2002	11/25/2002	0		PUB	UNK	NONE	Non-specific hearing loss	UNK			1						1	Conjunctival haemorrhage	FLU3~SANOFI PASTEUR~40956AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0196026	01/10/2003	TN	59.0	58		F	01/02/2003	10/25/02 Date of vaccine: loss of feeling in right arm all the way to right hand; loss of feeling in left hand 2 days later; Increased anxieties. (No treatment by that physician.) Ongoing loss of feeling. The follow up states my right arm continues to ache and have loss of feeling as well as my left hand and the back of my right leg and the balls of my feet are sensitive and ach. This is not getting any better 1/22/03.								Y	N	10/25/2002	10/25/2002	0	EMG, Neuropahty Paripheral	PVT	PVT	Nexium; Xanax; Aspirin Free/ Excedrin	NONE				1						1	Hypoaesthesia; Pain; Paraesthesia; Hypoaesthesia; Nerve injury; Oedema; Paraesthesia	FLU3~SANOFI PASTEUR~U0910AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0735M~1~~RA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~0735M~UNK~~~PNEUMO (PNEUMOVAX)~2	USA	Disabling	Influenza
0196034	01/10/2003	MN	0.5	0	.5	F	01/09/2003	Pt received influenza vaccine on 11/6/02 for the first time on the evening of 11/7/02. She had an episode of seizure like activity for 20 minutes. She had repeated flexion of her arms and head that looked like a sneeze but she was not sneezing. No breath holding. NO post ictal behavior afterward. She vomited once prior to the episode. No further episodes. She was sent to neurologist.				Y					Y	11/06/2002	11/07/2002	1	EEG normal	PVT	PVT	Iboprofen	NONE	NONE			1						1	Convulsion; Vomiting	DTAP~SANOFI PASTEUR~U0584CA~3~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U0939AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~U1428~3~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~489469~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0196100	01/11/2003	OK	59.0	59		F	01/11/2003	Shot was quite painful and swelling was within 30 minutes.  Swelling continued until a large area in the muscle developed.  After approximately 2 weeks, my arm was nearly paralyzed.  I couldn't lift it away from my body.  It continued to worsen.  I couldn't sleep at night because of the severe pain.  I finally went to my doctor and he thought it might be a hemmatoma.  However, an ultra sound test did not confirm that.  I am presently in physical therapy to regain use of my arm.  The swelling is still there, but it has subsided.  I still experience pain and have a prescription that I find it necessary to use at night.  I did report this to the VNA				Y					N	11/07/2002	11/07/2002	0		PUB	UNK	None  A pain medication (Darvocet) was prescribed when I visited my doctor to help me sleep at night.  However, I was not on any medication when I received the shot.	None	None			1						1	Haematoma; Insomnia; Movement disorder; Oedema; Pain	FLUX~UNKNOWN MANUFACTURER~90658/VO4.9~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0196051	01/13/2003		1.3	1	.4	M	01/08/2003	From telephone contact received on 12/26/02, it was reported that a 16 month old male received Fluzone SV '2002-'2003 (lot number U0927) on 10/23/02 and 12/2/02. Sometime after receiving the vaccination, the child developed a fever and croup. The reporter, who is the mother of the child, stated that her son also has autism; he does not look at her and does not hear her. The lot number reported is incomplete. Further info has been requested. Seriousness criteria: other medically significant (OMIC). Follow up on 08/22/2003: From telephone contact with the reporter on 08/15/2003: the mother was reluctant to release any information but stated she would foward AP's phone number and contact information to her son's physician, which was provided, in addition to a change in the reporter's phone number. Follow up on 01/21/04: No further informationw as obtainable for this case. No further information is anticipated, this case is considered closed.									U	12/02/2002				OTH	OTH					U200201149	1						1	Cough; Dyspnoea; Laryngitis; Pyrexia	FLU3~SANOFI PASTEUR~U0927~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0196052	01/13/2003	NC	33.0	33		F	01/10/2003	Arm swelled from flu shot at injection site. Hard lump about the size of a quarter at flu site injection. Still have the lump. Received Pneumovax a second before flu vax. Extremely painful could not sleep on arm for a month.				Y				Y	N	12/19/2002	12/19/2002	0		UNK	UNK						1						1	Injection site induration; Injection site mass; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U0925AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1|TTOX~SANOFI PASTEUR~U0528AA~UNK~~~TETANUS TOXOID (NO BRAND NAME)~1	USA	Disabling	Influenza
0196053	01/13/2003	NM	53.0			M	01/06/2003	Bell's Palsy			Y						Y	10/18/2002	10/21/2002	3	Medical record states hyperglycemia. msv	UNK	UNK	Insulin; Actace; Vitamins	NONE	Insulin resistant DM; MVP			1						1	Facial palsy; Hyperglycaemia	FLU3~SANOFI PASTEUR~U0971AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0196057	01/13/2003	MI	86.0	86		F	11/05/2002	Received Flu vaccination on 11/4/02 around 13:00. At 19:00, that evening, she was feeling very cold, shaky and thirsty. She went to Urgent Care at 21:30 and was examined by MD. She was sent home with instructions to follow-up with her doctor. When she was at Urgent Care, she was told that a young man had came in with similar symptoms. Pt called her son, who is a doctor, and he told her the Flu shot may be a contaminated batch. Pt's symptoms subsided without intervention around 23:00 and she slept like a log for 8 hours. She stated that she did not eat anything from noon until 19:00 on 11/4/02. She drank a couple cans of pop when she was feeling very thirsty.				Y					U	11/04/2002	11/04/2002	0	Urine testing-result not known	PUB	PUB	Lanoxin; Avapro; Lasix; K-dur; Fosamax; Coumadin; ?	NONE	High blood pressure; heart problems; history of skin cancer in remission		MI2002094	1						1	Feeling cold; Oral intake reduced; Thirst; Tremor	FLU3~PFIZER\WYETH~4020021~2~SC~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0196058	01/13/2003	AR	37.0	37		F	11/25/2002	Received Flu vaccine on 11/22/02 and has bruise and swelling. She used ice packs. No medical care required.									Y	11/22/2002	11/22/2002	0		PUB	PUB					AR0266	1						1	Contusion; Injection site swelling	FLU3~PFIZER\WYETH~4020008~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0196059	01/13/2003	WI	54.0	53		F	11/13/2002	Received flu shot on 10/30/02. Went to Occupational Health on 11/01/02 for c/o tenderness and aching in injection area and had a large reddened area approx. 20cm per RN's nursing notes. Tylenol used/recommended. No further problems. Thought to have been administered incorrectly. Numerous flu shots given throughout the past with on problems.									Y	10/30/2002	11/01/2002	2	NONE	PUB	PVT	Prevacid	NONE	Gastric Reflux			1						1	Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U0958AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0196060	01/13/2003	AL	0.6	0	.6	M	12/20/2002	Large welts all over his body, temperature of 100.1F, eyes swollen together, blood vessels popped and caused bruising. States he had some swelling X 2 weeks. Medication was given. Mom does not know what was given.				Y					Y	11/22/2002	11/23/2002	1		PUB	PUB	NONE	NONE	Reflux; questionable baby asthma		AL0232	1						1	Contusion; Eye swelling; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U0198AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0196061	01/13/2003	WI	30.0	30		F	01/06/2003	Pt had swollen arm that was hot and itching which lasted 3 days.									Y	12/27/2002	12/28/2002	1		PUB	PUB	Atenolol; Ortho-Cyclen	NONE	High BP			1						1	Injection site hypersensitivity; Injection site swelling; Injection site warmth; Pruritus	FLU3~PFIZER\WYETH~4020027~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0196062	01/13/2003	OR	64.0	64		F	01/02/2003	Received flu shot on 10/11/02, just before noon. By evening, I had hives all over my body. I still have the hives as of this date.				Y					N	10/11/2002	10/11/2002	0		PVT	UNK		NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U0883AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0196087	01/13/2003	FL	1.08	1	.1	F	01/02/2003	Bumps on back and itching.									Y	12/12/2002	01/02/2003	21	NONE	PVT	PVT		NONE				1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U0954AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0813M~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0202M~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0196098	01/13/2003	CA	58.0	58		F	01/10/2003	Pain at injection site on left deltoid, immediately following vaccination. Febrile X 3 days and off work X 3 days following vaccination. Advil taken daily. Two weeks, post vax, developed swollen left deltoid, hot to touch with redness. Saw MD and Dx'd with cellulitis. Rx'd Zithromax, Becstra and Ultracef. Infection resolved. Pain has diminished but not resolved.				Y					N	11/19/2002	12/06/2002	17		PUB	PUB	Estrace; vitamins				CA020106	1						1	Cellulitis; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U0953AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0196169	01/13/2003	WA	2.0	2	.8	M	01/13/2003	swelling, redness, itching, and warmth of entire forearm after administration of influenza vaccine and dT vaccine. No fever or other systemic signs.				Y					U	01/10/2003	01/11/2003	1		PVT	PUB	Amoxicillin low dose chronic therapy	None	multiple food allergies including egg, asthma, GU reflux			1						1	Erythema; Feeling hot; Oedema; Pruritus	DT~BSI~v0306ac~3~IM~RA~DT ADSORBED (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~v0909aa~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0196120	01/14/2003	IL	4.0	4		M	01/09/2003	Administered DTaP, MMR, IPV and flu vaccines at approx 2:15pm. By 4:15pm was breaking out in tichy rash on trunk. By approx 5pm when sought medical attention at local ER was experiencing urticaria over entire body, including face, neck, extremities, and trunk.			Y	Y					Y	12/31/2002	12/31/2002	0	NONE	PUB	PUB	NONE	NONE	Asthma		IL03001	1						1	Pruritus; Rash; Urticaria	DTAP~SMITHKLINE BEECHAM~553A2~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U0922AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~U1082~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0339M~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Life Threatening	Influenza
0196122	01/14/2003	TN	2.0	2	.1	M	01/13/2003	5 min after vaccine; Rash on face; 1 tsp Benadryl									Y	01/13/2003	01/13/2003	0		PVT	UNK						1						1	Rash	FLU3~PFIZER\WYETH~4020017~1~IM~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0196127	01/14/2003	OH	66.0	66		F	12/09/2002	C/O severe pain (8 on 1-10 scale) in biceps and triceps which began three days post receiving flu vaccine. Pain has interfered with normal ROH-no redness, swelling at any time. Ice provided short-term relief-has taken no medication. Not seen physician.									N	11/13/2002	11/16/2002	3	NONE	PUB	PUB		NONE	MS			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U0938AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0196128	01/14/2003	OH	74.0	74		M	12/09/2002	C/O pain in arm at time of injection-stated he felt injection was given too high. C/O soreness in deltoid area which has led to decreased ROM. Denies redness, swelling, warm at injection site. Has not taken any medication. Not used ice/heat treatment, not sought medical care.									N	11/13/2002	11/16/2002	3	NONE	PUB	PUB		NONE				1						1	Injection site pain; Joint range of motion decreased	FLU3~SANOFI PASTEUR~U0938AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0196129	01/14/2003	TN	60.0	60		F	01/08/2003	Pt called 1/4/03 to let us know about the event. The site was sore a few days after but a knot formed at the site. Continued to be sore until the knot left this past week.									Y	12/02/2002	12/03/2002	1		OTH	PVT						1						1	Injection site mass; Injection site pain	FLU3~EVANS VACCINES~E33502HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0196130	01/14/2003	CA	1.8	1	.9	M	01/03/2003	Influenza given 11/25/02-achy only. Influenza given 1/3/03 hives on leg where IZ given, now all over, come and go.									U	01/03/2003	01/03/2003	0	NONE	PVT	UNK	NONE	NONE	NONE	Achy only~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Urticaria	FLU3~PFIZER\WYETH~4020034~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0196131	01/14/2003	MA	5.0	4		F	01/08/2003	Bell's palsy-Lt sided pacial paralysis.  Bell's Palsy occurred 1 week after flu vaccine. Medical record states drooping of eye, edema of face. msv									U	12/30/2002	01/06/2003	7	CBC normal, momo-ng, lyme titer neg	PVT	PUB						1						1	Face oedema; Facial palsy; Ophthalmoplegia	FLU3~SANOFI PASTEUR~U0953AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0196132	01/14/2003	PA	48.0	48		F	01/07/2003	Pt states the flu vaccine site became sore almost immediately. She stated the injection felt different from other flu injections she had gotten previously. Soreness radiated from the injection site. Pt calls our office complaining that the L arm from the shoulder to upper arm is still sore. She states there was no ? redness, swelling or bruising. Advised to see MD 1/6/03. The follow up states pt was advised to see her doctor.									U	12/12/2002	12/12/2002	0		OTH	PVT						1						1	Injection site pain	FLU3~SANOFI PASTEUR~U0909AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0196133	01/14/2003	MS	23.0	23		M	01/06/2003	Vaccine 18 Oct and 2nd 2 wks later. Symptoms 11/13/02=SOB and increased heat rate. Pt sent for full work up. Dia: anxiety. Pt did have similar sx's one year prior. Feels better but not 100%.				Y					U	11/01/2002	11/13/2002	12	Echo, Holte,r GXT, PFT labs Hdger=sinus tochy	MIL	MIL	NONE	NONE	Seasonal and ASA			1						1	Anxiety; Body temperature increased; Dyspnoea	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~2~~~MENINGOCOCCAL (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0196134	01/14/2003	WA	22.0	22		F	12/31/2002	Muscle soreness, swelling and pain which began shortly after vaccine and lasted over a week. Same symptoms affected the 2 other marines that I live with, neither of which filed a report.									Y	11/09/2002	11/09/2002	0		MIL	MIL	Ortho-Cyclen	NONE	NONE			1						1	Injection site pain; Injection site swelling; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0196135	01/14/2003	OK		48		F	01/06/2003	Affected deltoid ached from right away after getting injection. Pain continued to increase for several hours until the next morning. Pain still present but mild 1 month later. Patient complaining of difficulty at times moving arm from flexed position to extended position.									N	12/05/2002	12/05/2002	0		PVT	PVT		Allergic Rhinitis with acute sinusitis	HTN, Hypertriglyceridemia, Post menopausal, Breast cancer, Mastectomy			1						1	Injection site pain; Joint range of motion decreased	FLU3~PFIZER\WYETH~4020018~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0196026	01/15/2003	TN	58.0	58		F	01/10/2003	Information has been received from a 58 year old female pt who on 10/25/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 643504/0735M). Concomitant therapy included Nexium, Xanax 2mg four times a day, aspirin free Excedrin three times a day, vitamin E and ascorbic acid. Subsequently on 10/25/02, the pt lost all feeling in her right arm and right hand. One week later on approximately 11/1/02, the pt lost feeling in her left hand. The pt also stated that her hands were swollen and tingly. The pt had a neuropathy test that showed she had nerve damage. Medical attention was sought through an office visit. Upon internal review, the pt's loss of feeling has been determined to be an other important medical event (OMIC). Additional info has been requested. The follow up received on 2/25/03 states medical attention was sought through an office visit. On 1/13/03 the pt reported that since vaccination, this has spread to the left arm and to the back of the right leg. Additional info is not expected.				Y					N	10/25/2002	10/25/2002	0	Diagnostic laboratory neuropathy test showed nerve damage	OTH	OTH	Aspirin free Exedrin; Xanax; Ascorbic acid; NEXIUM; Vitamin E		Drug hypersensitivity		WAES0301USA00123	1						2	Hypoaesthesia; Pain; Paraesthesia; Hypoaesthesia; Nerve injury; Oedema; Paraesthesia	FLU3~SANOFI PASTEUR~U0910AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0735M~1~~RA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~0735M~UNK~~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0196190	01/15/2003	UT	85.0	85		M	12/23/2002	Client came to clinic on this date. Had redness, slight swelling, some warmth to the touch and ecchemosis down his entire right arm and into the wrist, especially on the interior aspect of his forearm.										12/19/2002	12/20/2002	1	NONE	PUB	PUB	UNK	NONE	UNK			1						1	Ecchymosis; Erythema; Feeling hot; Swelling	FLU3~PFIZER\WYETH~4020027~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1161L~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0196194	01/15/2003	NH	1.2	1	.2	M	12/31/2002	12/31/02 After both immunization with Fluzone, patient developed high fever to 104 degrees within 24 hours after vaccination. Fever persisted for 4 days with cough, congestion, malaise, irritability, diarrhea, vomiting. 1/2/03 Still with high fever 104 degrees. Treated with Rocephin and Suprax.				Y					Y	12/26/2002	12/27/2002	1	CBC showed normal results on 12/30/02; CXR WNL	PVT	PUB	NONE	NONE	NONE			1						1	Cough; Diarrhoea; Irritability; Malaise; Nasal congestion; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0196195	01/15/2003	NM	77.0	77		M	01/06/2003	Within on day of getting flu vaccine a rash started on the torso which caused itching and then spread over the whole body. The severe itching and scratching has caused sores and scabs, almost 3 months now.				Y					N	10/22/2002	10/23/2002	1		PVT	UNK						1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U0833AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0196196	01/15/2003	NM	76.0	76		F	01/06/2003	Within one day of getting flu vaccine a rash started on the torso which caused itching and then started spreading over the whole body. The severe itching and scratching has caused sores and scabs, this has been going on for almost 3 months now.				Y					N	10/22/2002	10/23/2002	1		UNK	UNK						1						1	Rash pruritic	FLU3~SANOFI PASTEUR~U0883AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0196197	01/15/2003	MN	0.5	0	.6	F	01/06/2003	Parents went into pt's room around 5:30pm, noticed face red and swollen. Called on-call MD. No medical attention needed. This was reported to us 1 week after vaccine.									Y	12/10/2002	12/10/2002	0		PVT	PUB		NONE	NONE			1						1	Face oedema; Flushing	DTAP~SMITHKLINE BEECHAM~A574A2~3~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U0958AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W0013~3~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~489701~3~IM~~PNEUMO (PREVNAR)~1	USA		Influenza
0196198	01/15/2003	NE	63.0	63		F	01/09/2003	Got flu shot left arm on 01/02/2003. Reaction started right away. Swollen/ puffy measured 7 1/2 cm by 7 cm									Y	01/02/2003	01/02/2003	0		PVT	PVT		NONE	NONE			1						1	Oedema	FLU3~SANOFI PASTEUR~U0903AA  exp 06~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0196201	01/15/2003	VA	25.0	25		F	12/29/2002	C/O itching at injection site, and chest tightness: No wheezing or hives: Arm swollen. Benadryl 50mgm IM given left deltoid. ER Tx STeroids, Histamine Blocker (Zantac), NEB Tx  in hospital for 5 days				Y					Y	11/22/2002	11/22/2002	0		OTH	PVT	UNK	UNK	NONE			1						1	Chest discomfort; Injection site hypersensitivity; Pruritus	FLU3~SANOFI PASTEUR~U0988BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0196202	01/15/2003	VA		59		F	12/27/2002	Sudden onset severe nausea and vomiting 1 hour after receiving shot. Called 911 after 90 mins of severe vomiting. Eval. by ER--Tx with IV's and antiemetics Went home with several hours. No additional. Tx nec. Er feels probably not   to flu shot.				Y					Y	11/01/2002	11/01/2002	0	UNK	OTH	UNK	UNK	NONE	Allergic to shellfish			1						1	Nausea; Vomiting	FLU3~SANOFI PASTEUR~U0911AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0196203	01/15/2003	VA	33.0	33		F	12/27/2002	C/O dizziness, sweating, shakiness apprx. 15 mins after flu shot. Face flushed. No hives, SOB or wheezing. (Only went to ER because another client was also going) ER states was vasovagal Rx IV fluids				Y					Y	11/22/2002	11/22/2002	0		OTH	UNK		NONE	No allergies			1						1	Dizziness; Flushing; Hyperhidrosis; Tremor	FLU3~SANOFI PASTEUR~U0988BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0196204	01/15/2003	VA	31.0	31		M	01/03/2003	C/O left arm feeling numb 30 mins after receiving flu shot. States same thing happened last year. The follow up states resolved without tx post 4-5 hrs.									Y	11/06/2002	11/06/2002	0		OTH	PVT	UNK	UNK	UNK	C/O left arm feeling numb 30 mins after receiving flu shot~Influenza (Seasonal) (Fluzone)~~30.00~In Patient		1						1	Hypoaesthesia	FLU3~SANOFI PASTEUR~U0911AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0196205	01/15/2003	VA	22.0	32		F	12/29/2002	C/O thick tongue, hard to swallow anxious. No SOB, wheezing, no erythema at injection site									Y	11/01/2002	11/01/2002	0		OTH	PVT	UNK	NONE	No allergies			1						1	Anxiety; Dysphagia; Tongue disorder	FLU3~SANOFI PASTEUR~U0911AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0196206	01/15/2003	VA	33.0	33		M	12/27/2002	Complained of tingling in fingers of left hand, shoulder and side mouth approximately 1 hour after shot. Neuromus v to hand/arm/mouth wnl; Resolved spontaneously within 5 hours.									Y	10/31/2002	10/31/2002	0		UNK	PVT	UNK	NONE	NONE			1						1	Paraesthesia	FLU3~SANOFI PASTEUR~U0911AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0196210	01/15/2003	OK	1.0	1	.0	F	12/18/2002	Induration for 2 weeks on left leg. + erythematous pustule on left thigh for one day, 2 weeks after vaccines.									U	12/03/2002	12/18/2002	15	CBC, BC	MIL	MIL		NONE	NONE	pustule~Varicella (Varivax)~~1.00~In Patient		1						1	Injection site mass	FLU3~SANOFI PASTEUR~40984AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~4829M~1~~RL~HIB + HEP B (COMVAX)~1|IPV~SANOFI PASTEUR~40425~1~~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0773M~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~491168~1~~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0588M~1~~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0196229	01/15/2003	FL	1.5	1	.3	M	01/08/2003	Mom states within 2 days post MMR vaccine, lost verbal intelligence skills and babbles away (non?).									U	10/23/2002	10/25/2002	2	NL MRI of brain; NL lead, mercury levels	PVT	PVT		NONE	Cystic adenomatoid mal?			1						1	Cognitive disorder	FLU3~SANOFI PASTEUR~U0977AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0694M~3~IM~RA~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0609M~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0196290	01/15/2003	CA	45.0	45		M	01/13/2003	Red swollen arm at injection site, spreading erythema to distance of 10x10cm									Y	12/11/2002	12/12/2002	1	none	MIL	MIL	lopid	none	sulfa, shellfish			1						1	Erythema; Injection site hypersensitivity; Oedema	FLU3~PFIZER\WYETH~4020032~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TYP~SANOFI PASTEUR~na~UNK~IM~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|YF~SANOFI PASTEUR~UB171AB~UNK~SC~~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0196284	01/16/2003	KY	38.0	38		M	12/18/2002	Pt presented with edema, tenderness to right upper arm, significant swelling noted with area of erythema around injection site. Motor/neuro muscular function normal in extremity. Treated with st?? dose pack, Benadryl and heat with resolution in 72 hours.									Y	12/12/2002	12/13/2002	1		MIL	MIL	PPD	NONE	NONE		KY2003002A	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site erythema; Injection site pain; Injection site swelling	ANTH~EMERGENT BIOSOLUTIONS~FAV065~6~SC~RA~ANTHRAX (BIOTHRAX)~1|ANTH~EMERGENT BIOSOLUTIONS~FAV05~6~SC~RA~ANTHRAX (BIOTHRAX)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0196284	01/17/2003	KY	38.0	38		M	12/18/2002	Pt presented with edema, tenderness to right upper arm and significant swelling noted in an area of erythema around injection site. Motor/neuro/vascular function normal in extremity. Treated with steroid dose pack, Benadryl and heat with resolution in 72 hours.									Y	12/12/2002	12/13/2002	1		MIL	UNK	PPD	NONE	NONE		KY2003005	1						2	Injection site erythema; Injection site pain; Injection site swelling; Injection site erythema; Injection site pain; Injection site swelling	ANTH~EMERGENT BIOSOLUTIONS~FAV065~6~SC~RA~ANTHRAX (BIOTHRAX)~1|ANTH~EMERGENT BIOSOLUTIONS~FAV05~6~SC~RA~ANTHRAX (BIOTHRAX)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0196298	01/17/2003					F		A report was received from a regulatory authority on 1/6/03, indicating that a female vaccinee was hospitalized for a productive cough, increased SOB and sweating, after receiving Fluvirin on 10/31/2002. After vaccination (time of onset not provided) the vaccinee experienced a productive cough with clear sputum, increased SOB and sweating and was hospitalized (date not provided). The vaccinee recovered after 3 days on 11/3/02. There was insufficient information to determine the reporter's causality assessment.					Y				Y	10/31/2002				UNK	UNK	ipratropium, salbutamol, budesonide, paracetamol and dihydrocodeine				PJP200300004	1						1	Cough; Dyspnoea; Hyperhidrosis; Productive cough	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0196299	01/17/2003	MS	40.0	40		F	12/16/2002	Mild headache 10/17/02 until 11/18/02 when had onset very severe headache unresponsive to multiple meds. Progressed to Rt 3rd cranial nerve palsy which persists. 10/16/02-had flu shot. 10/17/02-bad headaches on Rt side of head only (started on Rt side 10/17/02. 11/21/02 with unreal severe headache). 11/18/02-middle of night, woke up to a severe headache on Rt side and faint feeling. 11/21/02-middle of night, woke up to the unreal severe headache. Had to go get medicine. Fainting, nausea, hot/cold sweats, pain was unbearable. 11/25/02-saw MD-got two temple injections-did not help pain. 11/27/02-got 1 shot immetrex in leg and prescriptions filled. 11/28/02-Thanksgiving day-eye started closing. 12/2-5/02-in hospital and eye closing more. By 12/5/02-eye closed. 12/10/02-appt with MD. 12/11/02-muscles around eye seems to be loosening up, causing less headaches and can seem to move eye today. 60 day follow up states pt has not recovered. Has CNS vascular with severe headaches and total ? 3rd C N palsy which has improved with large doses of steroids. Headaches started day after injection. (unknown) any realtionship					Y	4			N	10/16/2002	11/18/2002	33		PVT	PVT	NONE	NONE	Allergic bronchitis, mild (not active); milk, nuts; kidney stones right side; 1995 gallbladder surgery; 1997-pneumonia			1						1	Dizziness; Eye disorder; Headache; Hyperhidrosis; Nausea; Pain; Paralysis	FLU3~EVANS VACCINES~E30442GA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0196309	01/17/2003	VA	57.0	57		F	12/09/2002	Injection painful at time of administration with bleeding and bruising occurring immediately. Shortly thereafter, site observed to be hot to touch with silver-dollar sized redness and swelling at site. In ensuing days, starting very soon, experienced muscle and joint aching. Heat persisted until 12/09/02. Some nausea, intermittently. Redness and swelling persisted for about 5 days and associated soreness at site.									Y	11/27/2002	11/27/2002	0	NONE	PVT	UNK		NONE				1						1	Arthralgia; Contusion; Injection site erythema; Injection site haemorrhage; Injection site pain; Injection site swelling; Injection site warmth; Myalgia; Nausea	FLU3~PFIZER\WYETH~4020036~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0196312	01/17/2003	NY	36.0	36		F	01/16/2003	Delayed anaphylactic reaction with severe hives, difficulty breathing, fever, nausea, dizziness, neck pain and spasms, shakiness, weakness in both arms and blurred vision. Made 3 trips to ER for Epinephrine and several meds; eye drops; and physical therapy is still on-going.				Y					N	12/04/2002	12/05/2002	1	Lots of blood work; Cat Scans; X-rays and eye tests	OTH	OTH	Oral contraceptive	NONE	NONE			1						1	Anaphylactic reaction; Dizziness; Dyspnoea; Muscle spasms; Muscular weakness; Nausea; Neck pain; Pyrexia; Tremor; Urticaria; Vision blurred	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0196313	01/17/2003	NJ		70		M	01/12/2003	Cough, congestion, low-grade fever and body aches. Recovery in progress.									U	01/06/2003	01/10/2003	4		PVT	PVT		NONE				1						1	Cough; Nasal congestion; Pain; Pyrexia	FLU3~EVANS VACCINES~E329726A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0196314	01/17/2003	MS	1.3	1	.4	M	01/11/2003	Pt had hives and hand swelling of both hands.				Y					Y	01/10/2003	01/10/2003	0	NONE	PVT	PVT	Protopic	NONE	Eczema			1						1	Oedema peripheral; Urticaria	FLU3~SANOFI PASTEUR~U0886AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0196315	01/17/2003	OH	31.0	31		M	01/09/2003	12/26/02 (02:00) numbness on right side of face and about midnight went to ER. Face paralyzed on right side speech and eyes. Prescribed Prednisone (30 of them) 10mg for 12 days. Dx: Bell's Palsy. No recovery yet. Would not have taken the Flu shot if I had known there was mercury preservative in it because my nephew has autism after childhood vaccinations.				Y					N	12/16/2002	12/26/2002	10		OTH	OTH	NONE	NONE	NONE			1						1	Facial palsy	FLU3~SANOFI PASTEUR~U0934AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0196344	01/17/2003	NY	51.0	51		F	01/13/2003	As per pt, received a flu shot on Thursday 11/14/02. Pt noted hives on the back of neck and hands the next afternoon. She took Benadryl for the itching. On 11/16/02 she continued to take Benadryl x 2 for hives. 11/17/02 pt woke up with welts all over her body and legs. She had facial swelling-face was twice its normal size and tongue started to swell. Pt went to ER-received Epinephrine, steroids and Tagamet. Monday 11/18 she feel better but then noted hives-lips started to swell-pt went back to ER got Benadryl injection. She experienced chest pressure and received Nrg without relief. Cardiac w/u was negative. The medical record states dizzy.				Y	Y	2			Y	11/14/2002	11/15/2002	1	For chest pressure had EKG, stress test, echocardiogram. All tests were wnl. Blood work up wnl as per pt.	PUB	OTH	MVI, Vit C, Vit E, calcium 600 po bid with Vit D.	NONE	NONE			1						1	Chest discomfort; Dizziness; Face oedema; Pruritus; Tongue oedema; Urticaria	FLU3~EVANS VACCINES~E35492KA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0196345	01/17/2003	NJ	59.0	59		M	01/16/2003	Pain and swelling in the left arm for 5 days. He did yard work after episode.									Y	10/14/2002	10/15/2002	1		PVT	PVT						1						1	Injection site pain; Injection site reaction; Injection site swelling	FLU3~PFIZER\WYETH~4020023~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0819M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0196533	01/17/2003	WA	29.0	29		M	01/17/2003	Pt received anthrax left arm at 1030 and flu-vaccine at 1300. By 1900 hours he developed pruritic red rash, initially beginning on his arm, and then progressing overnight to also iclude face, trunk, back, palms. Also asscoiated with mild fever, but no other systemic symptoms. On exam the next day he had multiple 1-2cm red, indurated lesions on his upper arms, forehead, palms, trunck, back. The remainder of his exam was normal. Pt was treated with course of prednisone and antihistamines and rash eventually resolved several days later.				Y					Y	12/13/2002	12/13/2002	0	Biopsy performed 14NOV02: superficial and deep perivascular and peri-adnexal lymphocytosis with extenstion into subcutaneous and adipose tissue (panniculitis). Scattered eosinophils. Features c/w drug reaction or autoimmune reaction. Lab tests to include CBC, chemsitries, LFT's, ESR, C3/4 were al normal.	MIL	MIL	None	None	None			1						1	Eosinophilia; Erythema; Lymphocytosis; Pyrexia; Rash pruritic; Skin ulcer	ANTH~EMERGENT BIOSOLUTIONS~FAV063~3~SC~LA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~Unknown~UNK~SC~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0196491	01/21/2003	NY	55.0	55		M	01/08/2003	Thrombocytopenia					Y					10/18/2002	10/24/2002	6	PLT Results : L 37 K/cmm; H: 450/L:150	UNK	UNK	Lisinopril; Docusate Sodium; Calcium Acetate; Sildenafil Citrate; Therapeutic Multivitamin; Folic Acid; Furosemide; Efavirenz; Glyburide; Metoprolol Tartrate; Sulfanethoxazole; Magnesium Oxide;					1						1	Thrombocytopenia	FLUX~UNKNOWN MANUFACTURER~~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0196493	01/21/2003	CA	67.0	67		F	01/16/2003	Pt received vaccine at approx. 16:00-17:00 on Thursday, 1/2/03. At 12:01 AM, Saturday, 1/4/03, she developed nausea, dizziness and vomiting every hour. She also developed headache, back ache and blurred vision and chest pressure.				Y					Y	01/02/2003	01/04/2003	2	EKG	PVT	PVT	Aspirin twice a day	NONE	Sinusitis			1						1	Back pain; Chest pain; Dizziness; Headache; Nausea; Vision blurred; Vomiting	FLU3~SANOFI PASTEUR~U0958AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0196496	01/21/2003	MO	48.0	48		F	01/17/2003	On 1/14/03, reported symptoms over the phone: Right arm is weak, can't lift items like pots and pans. Arm is sore and has pain when lifts arm above ear level. Also, pain if she lays on it. Complained of soreness at site and swollen right hand. No swelling noted.									N	12/20/2002	12/20/2002	0		PUB	OTH	UNK	NONE	NONE			1						1	Hypokinesia; Injection site pain; Oedema peripheral; Pain	FLU3~PFIZER\WYETH~4020025~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0196497	01/21/2003	IA	46.0	46		F	01/14/2003	Hives				Y						01/03/2003	01/03/2003	0		PVT	UNK		NONE				1						1	Urticaria	FLU3~SANOFI PASTEUR~U0950AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0196498	01/21/2003	MN	57.0	57		M	01/03/2003	About 1 week after flu shot, pt noted pruritus in left deltoid area. Pruritus has spread to dorsal trunk. Shortly after the pruritus started, he developed erythematous macular-papular rash which continues to spread. Seen on 12/19/02 at clinic with rash/itching on dorsal trunk and LUE. No SOB or fever.				Y					N	11/05/2002	11/12/2002	7	NONE	PVT	UNK	Sulindac; cholestyramine; allopurinol; Asacol; HCTZ	NONE	Crohn's Disease; ? necrosis of hip on prednisone; HTN			1						1	Injection site reaction; Pruritus; Rash maculo-papular	FLU3~SANOFI PASTEUR~U0938AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0196499	01/21/2003	WI	60.0	60		M	01/10/2003	Moderate to intense itching and fatigue.									Y	01/03/2003	01/03/2003	0	NONE	PVT	PVT	Allegra D; Protonix	NONE	Multiple allergies: environmental, food and chemical			1						1	Fatigue; Pruritus	FLU3~SANOFI PASTEUR~U0958AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0196500	01/21/2003	FL	50.0	49		M	01/06/2003	Numbness and tingling of left pinky and ring finger and extending to left wrist. TX: Physical Therapy.				Y					N	10/31/2002	11/17/2002	17	X-ray-left hand	OTH	OTH	Lotensin 10mg q d; Catapres 1mg q d; Lescol 80mg q d	NONE	Hypertension			1						1	Hypoaesthesia	FLU3~SANOFI PASTEUR~U0921EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0196501	01/21/2003	UT	59.0	59		M	01/10/2003	Noon shot; went back to work. Arm was sore and I was tired. Went home and went to bed. Had fever and shakes the next morning at 09:00. Went to doctor's office and fever was 104F but shakes had stopped. Benadryl, Celebrex and Bextra given by doctor. Pt improved. DX: Anaphylactic/allergy to either Pneumonia or Infanrix.				Y					Y	12/04/2002	12/04/2002	0		OTH	PVT	Vitamins	NONE	NONE			1						1	Anaphylactic reaction; Fatigue; Injection site pain; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U0981AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0955M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0196517	01/21/2003	TX	64.0	64		F	01/18/2003	Redness, swelling of right deltoid (site of shot), starting 5 hours, post vax. Required admission for cellulitis.					Y				Y	10/22/2002	10/22/2002	0	WBC-15,000; Cultures-neg; venous angiosyn right arm-neg	PVT	PVT	Flumadine; Premarin; Cardizem; Isordil; Synthroid; Zocor; ASA; K-tabs, Co Q 10	Resolving flu-like illness	Allergy to Bactrim and Zithromax			1						1	Cellulitis; Injection site erythema; Injection site swelling; White blood cell count increased	FLU3~EVANS VACCINES~E35452HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0196518	01/21/2003	KS	74.0	74		F	11/12/2002	11/3/02, began to feel ill with fever, severe headache, coughing and chest congestion. 11/10/02, went to ER and got an injectable antibiotic and Legaquin 500mg, po q d.				Y					Y	10/30/2002	11/03/2002	4		PUB	PVT		NONE	NONE		KS200229	1						1	Cough; Headache; Pulmonary congestion; Pyrexia	FLU3~SANOFI PASTEUR~U0877AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0196572	01/21/2003	NC	26.0	26		M	01/21/2003	Pt. died 2 days after receiving vaccines. Autopsy resutls pending. Specimens to be sent to CDC for testing. Autopsy report received on 2/12/2003 indicates overdose.	Y	01/10/2003							N	01/08/2003	01/10/2003	2	Autopsy performed by Dr. Results pending. Specimens to be sent to CDC for testing.	MIL	MIL	NONE	NONE. HIV test done on 1-8-03. Results pending.	History of IV drug abuse including heroin prior to military enlistment			1						1	Overdose	FLU3~SANOFI PASTEUR~4020032~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~SANOFI PASTEUR~U0704~1~~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|YF~SANOFI PASTEUR~UB307AB~1~~~YELLOW FEVER (YF-VAX)~1	USA	Results in Death	Influenza
0196579	01/22/2003	CA	42.0	42		F	01/20/2003	Information has been received from a 42 year old female consumer. In Nov-2001, she received a dose of Flu-shield (2001-2002 formula). Six weeks post-vaccination, she developed blurry vision. In Jun-2002, at 43 years of age, she was diagnosed with multiple sclerosis. She indicated that she has received injections of influenza vaccine in 1999 and 2000 without problems. No further info was available at the date of this report. These events were considered medically important (OMIC).									U	11/01/2001	06/01/2002	212	UNK	PVT	PVT	NONE	UNK	UNK		HQ6224316JAN2003	1						1	Multiple sclerosis; Vision blurred	FLU3~PFIZER\WYETH~4018023~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0196581	01/22/2003	VA	21.0	20		M	01/02/2003	Severe headaches, back tightness and pain, tingling, pneumonia, tired, swollen glands, double vision, paralysis, mono. 11/19/01 flu shot. 12/17/01 collapsed. 12/18/01-12/12/24/01 critical care. 12/25/01-1/3/02 intermediate care. 1/4/02-1/17/02 rehab. hospital out patient. 1/18/02-3/18/02 rehab. Thorocic nerve continues to heal.			Y	Y	Y	33	Y		Y	11/19/2001	11/20/2001	1	Spinal Tap 12/16/01	OTH	OTH	NONE	Not feeling 100%	High cholesterol			1						1	Back pain; Circulatory collapse; Diplopia; Fatigue; Headache; Lymphadenopathy; Musculoskeletal discomfort; Paraesthesia; Paralysis; Pneumonia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0196592	01/22/2003	OH	46.0	47		F	01/21/2003	Pain and decreased mobility that is continuing.				Y					N	11/01/2003	11/01/2003	0		UNK	UNK						1						1	Joint range of motion decreased; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0196593	01/22/2003	TX	30.0	30		F	01/14/2003	1/10/03 elevated temp 102.4 and headache, left deltoid swollen and purple. 1/11/03 still elevated temp 103.5 came down with Tylenol and Motrin. 1/12/03 temp normal and arm normal by pm.									Y	01/09/2003	01/10/2003	1		PUB	PUB			NONE			1						1	Contusion; Injection site oedema; Pyrexia	FLU3~SANOFI PASTEUR~U0925AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0527M~UNK~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TD~SANOFI PASTEUR~U0527AA~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0196594	01/22/2003	NM	78.0	78		M	01/08/2003	Received flu vaccine Oct-2002 L DIM-client states in two days that pain and couldn't lift his arm.									N	10/25/2002	10/27/2002	2		PUB	PUB	Icy hot salve	NONE	Arthritis		NM010103	1						1	Hypokinesia; Pain	FLU3~PFIZER\WYETH~4020008~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0196595	01/22/2003	MA	71.0	71		F	12/30/2002	I have been receiving flu shots for years. I received a pneumonia shot about 1991. I haven't had any reaction to either type, on any of those occasions. This 11/22/02, I was advised by those offering innoculations at the senior center that now, all those that had pneumonia shots before they were 65 if 5 or more years have passed, they should have a second shot. On 11/22/03 at about 2:30PM, I was given both the flu shot and the pneumonia shot in the shoulder of my left arm. I was told that both shots were given in the same arm with no problem. About 4PM, first symptoms: increasing pain in the area of where the shots were given. About 5 to 6PM, increased pain and couldn't lift my arm; upper arm hard at touch and white. About 7:30PM increase in pain in arm and shoulder, headache and sick to my stomach. Was very cold and couldn't get warm even with additional clothes. At 9PM, went to bed in a lot of pain. 10PM couldn't put any weight on arm. Shivering constantly even under multiple blankets; temperature of 101 and couldn't move arm. Very sick all night and fever continued, but was too ill to bother taking temperature and go to the hospital. Just wanted to stay in bed. 11/23 AM brought relief from fever, somewhat; arm hard and now red from shoulder to inner elbow; still extremely painful.  Called CDC and couldn't get to talk to anyone. Was in pain all weekend and Monday called CDC again and was told to call VAERS. I was told that I should fill out a form to report the experience and it would be mailed to me, which I received a few weeks later. I went to the visiting nurse association to get the vaccine information requested on the form sent to me, but had to wait until after the director came back from days off. I am still having weakness and at times pain and soreness in upper arm and shoulder. I am concerned now as to if I should continue to receive either of these types of innoculations, as I have no idea which vaccine was the problem. Nurse follow up on 06/08/044 states: swelling.				Y				Y	Y	11/22/2002	11/22/2002	0	NONE	PUB	OTH	Synthroid; Lipitor, Avapro, Nadalol; Hydrochort; Ranitidine; Folic Acid	NONE	High BP; cardiac ischemia  ISCHEMIA MYOCARD     hypertension   HYPERTENS     hypothyroid   HYPOTHYR       esophageal reflux  GI DIS     anxiety    ANXIETY     depression   DEPRESSION     bilateral carpal tunnel  TENOSYNOVITIS     hypercholesterolemia  HYPERCHOLESTEREM			1						1	Chills; Erythema; Headache; Injection site induration; Injection site pain; Joint range of motion decreased; Nausea; Oedema; Pyrexia; Shoulder pain	FLU3~SANOFI PASTEUR~U0969AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0923L~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0196596	01/22/2003	SC	72.0	72		F	01/15/2003	12/17/02 for 11/25/02. Pt called to say that Td from clinic had made her arm very painful, some redness-no temp. Advise warm or cold compress and to check with MD. Advil or pain/antiinflam prn. Then 11-2n I called her for f/u seems better with warm comp. and Advil. Still hurts some. Did  not ever call MD. Advise, RTC prn. 1/10/03 pt called to report that her arm is still sore. Not at the Rt shoulder joint but mid right upper arm. She says that she has limited ROM and pain. She denies redness or swelling and says it does not feel hot to the outside touch, but feels hot to her inside. Pt says that she has been to her family doctor on 12/17/02 once for this problem. She is taking Rx: Bextra with diagnosis of Bursitis. 1/13/03 I called pt for follow up. She says her arm is a little better, but still sore. She is NKA, has osteoporosis, hypertension and diabetes mellitus. She takes Atlace for HTN and no Rx for diabetes. I explained the VAERS reporting system and told her that we would continue to follow up.				Y					U	10/29/2002	10/30/2002	1		OTH	PUB	Altace, Bextra	NONE	Hypertension, diabetes mellitus, osteoporosis		SC0264	1						1	Hypokinesia; Injection site erythema; Injection site inflammation; Injection site pain; Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~U0921DA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0524AA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0196597	01/22/2003	SC	44.0	44		F	12/20/2002	Client reported had redness, swelling L upper arm; spasms in back of head and down neck which began on 12/17/02. Client at HD 12/20 for PPD read and no redness, swelling observed. Hx panic/anxiety attacks and client takes Paxil for. Client reports has had spasms before if doesn't take Paxil regularly.				Y					Y	12/16/2002	12/17/2002	1	Consent obtained to get note from MD re: 12/17/02 assessment.	PUB	PUB	Paxil		Panic attacks/anxiety per client report. Spasms.		SC0262	1						1	Injection site erythema; Injection site oedema; Muscle spasms	FLU3~PFIZER\WYETH~4020027~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0196598	01/22/2003	AR	30.0	30		F	11/08/2002	Pt is the high school nurse and she received her flu vaccine at the school 11/05/2002 at 08:30. Apprx. 1 hour later she began to break out and itch all over. She took Benadryl that day and didn't report for work the following day. The rash was much better by 11/07/2002. She states she has been on a increased carb. diet and eating lots of eggs and had a earache the night before (11/04/2002) and used Floxin ear drops. Denies allergies									Y	11/05/2002	11/05/2002	0	NONE	OTH	OTH	Floxin eardrops used the night before	earache	NONE		AR0302	1						1	Rash pruritic	FLU3~PFIZER\WYETH~4020021~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0196599	01/22/2003	FL				F	01/03/2003	Swelling, erythema, pruritis, large swollen area at site, warm, tender, itchy.									Y	11/13/2002	11/14/2002	1		OTH	PUB	Sertraline, Fexofenadine		Sulfa, Neomycin Ointment			1						1	Feeling hot; Injection site erythema; Injection site oedema; Injection site pain; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0196600	01/22/2003	MI	82.0	82		F	12/26/2002	3-4 days after vaccination, she developed a rash which started on her legs and has spread to her back, arms, and hands. Rash consist of quarter size red- purple blotchy spots which are not raised and do not itch.				Y						12/05/2002	12/08/2002	3	Blood work drawn- all normal	PUB	PVT		NONE	NONE		MI2002095	1						1	Erythema; Rash; Rash maculo-papular	FLU3~PFIZER\WYETH~4020027~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0196601	01/22/2003	WI	41.0	40		M	01/10/2003	Moderate to severe pain in shoulder. Weakness in the tricep.										12/26/2002	12/26/2002	0	Shoulder X-ray. CBC- increase WBC    ESR	PVT	PVT		NONE	Allergic rhinitis			1						1	Muscular weakness; Pain	FLU3~EVANS VACCINES~E37182KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~SANOFI PASTEUR~U0818AA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0196602	01/22/2003	NY	42.0	32		F	01/13/2003	Redness and swelling, developed into lymphadenopathy									Y	10/08/2002	10/09/2002	1	NONE	PUB	OTH						1						1	Erythema; Lymphadenopathy; Oedema	FLU3~SANOFI PASTEUR~U0969AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0196603	01/22/2003	MD	42.0	41		F		Right arm red and fever				Y					N	01/08/2003	01/09/2003	1	CBC  WBC 9.2  Polys 80 Lymph 11	PVT	PVT	Flovent	NONE	Asthma Allergies			1						1	Erythema; Pyrexia	FLU3~EVANS VACCINES~E33152GA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1026M~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0196604	01/22/2003	NV	67.0	67		F		Flu symptoms- severe headache. Stayed prone for 2 solid days. Could hardly move- recovery- 4 days									Y	12/18/2002	12/18/2002	0		PUB	PVT			NONE			1						1	Headache; Influenza like illness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0196605	01/22/2003	KS	1.0	0	1	F	12/13/2002	11 hours after influenza shot had fever with seizures. Emesis x 3. Went to ER- received Motrin. No further treatment.				Y					Y	12/05/2002	12/05/2002	0		PVT	PUB						1						1	Convulsion; Pyrexia	FLU3~SANOFI PASTEUR~U0949AA~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0196606	01/22/2003	NY	13.0	13		F	01/10/2003	Swollen lips= symptoms Red, raised rash= symptoms									Y	01/09/2003	01/10/2003	1	NONE	PVT	OTH		Pharyngitis	Asthma			1						1	Face oedema; Rash erythematous	FLU3~SANOFI PASTEUR~U0934DA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0196689	01/23/2003	VA	92.0	92		M	01/22/2003	Numbness in right hand. Unsteady gait and bilateral leg weakness.				Y					N	11/05/2002	11/19/2002	14	NONE	MIL	PUB	NONE	Macular degeneration of Retina	Sulfa Drugs, History of Weakness			1						1	Asthenia; Gait disturbance; Hypoaesthesia	FLU3~SANOFI PASTEUR~U0959AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0196693	01/23/2003	OK	28.0	28		F	01/14/2003	1/11/03 Took Anthrax vaccine and influenza vaccine. 1/12/03 Nausea, upset stomach, cold chills. 1/13/03 Weak, back and muscle aches, tired, cold chills. 1/14/03 Dizziness, cold chills, aches. Seen doctor on 1/14/03 and gave me nausea medicine.				Y						01/11/2003	01/11/2003	0		OTH	MIL	NONE					1						1	Asthenia; Back pain; Chills; Dizziness; Fatigue; Myalgia; Nausea; Stomach discomfort	ANTH~EMERGENT BIOSOLUTIONS~FAV069~1~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0196696	01/23/2003	AZ	64.0	64		F	01/13/2003	Turner Parsonage Syndrome = vaccination associated acute left brachial plexopathy. Treatment: inflammatories, Physical therapy.									N	11/08/2002	11/09/2002	1	EMG 12/5/02; C-Spine x-ray and left shoulder x-ray 12/3/02.	PVT	UNK						1						1	Lung disorder	FLU3~SANOFI PASTEUR~U0968AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0196697	01/23/2003	GA	37.0	37		F	01/22/2003	Dizziness, migraine, blurred vision. On 12/20/02 had vomiting and diarrhea. Could not drink water or keep anything down. Severe abdominal cramping. *Follow-up report received on 2/5/03: Vomiting, diarrhea, abdominal cramping, migraine headache, blurred vision, dizziness, couldn't keep down or keep water in stomach for 24 hrs.									Y	12/17/2002	12/18/2002	1		PVT	UNK	Antibiotics for ear infection	Ear infection	Hay fever, pollen, pine			1						1	Abdominal pain; Diarrhoea; Dizziness; Migraine; Vision blurred; Vomiting	FLU3~PFIZER\WYETH~4020037~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0196747	01/23/2003	KS	65.0	65		F	11/06/2002	The pt called on 11/1/02, complaining of a sore arm. Call returned by RN and she states her arm still sore and having difficulty raising arm to comb her hair. States she was at MD's office yesterday and the nurse looked at her arm and states it looked normal. The pt stated she did not want to go to MD and would call if arm not improved. Pt states arm still hurts but relieved with Tylenol.				Y					N	10/09/2002	10/09/2002	0		PUB	PVT		NONE	NONE		KS200231	1						1	Hypokinesia; Pain	FLU3~EVANS VACCINES~E34712HA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0196757	01/23/2003	NY	3.0	2	1	M	01/23/2003	Fever to 105, generalized febrile seizure within 24 hours of vaccine administration.				Y					Y	12/23/2002	12/24/2002	1		PVT	PVT		Left ottitis media with effusion				1						1	Febrile convulsion; Pyrexia	FLU3~SANOFI PASTEUR~UO937AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192477	01/24/2003	WA	22.0			F	01/22/2003	From information received at manufacturer on 1/13/03, it was reported that a 22 year old female was administered FLUZONE SV 2002-2003 (lot # U0983WA) IM in the deltoid and YF-VAX (lot # U0253AA) SC in the deltoid on 10/17/02. On 10/21/02 at 08:05AM she experienced fever, nausea, vomiting, diarrhea and mildly elevated liver function tests. She was admitted to hospital. A spinal tap was performed on 10/23/02, which was within normal limits except for an elevated CSF glucose level 72.0 (normal range 40-70mg/dL). On 10/25/02, an exploratory laparotomy, partial colectomy, and lymph node biopsy were performed. Path results showed areas of colon and terminal ileum with mucosal acute inflammation, epithelial erosion and necrosis, as well as marted submucosal edema with acute and chronic inflammation. The muscularis propria and serosa showed mild acute and chronic inflammation, which were interpreted as being consistent with ischemic bowel disease. There were rare mucosal and submucosal lymphoid follicles with evidence of hemophagocytosis. No vascular emboli or evidence of vasculitis were identified. No parasite, granulomas or neoplastic changes were identified. Colonic and terminal ileum surgical margins were inflammed, margins viable. The appendix showed mild acute and subacute appendicitis. Lymph node biopsy showed marked interfollicular hyperplasia and sinus histiocytosis with hemaphagocytosis, suggestive of hemophagocytic syndrome. 30cc of bile was also removed for analysis. Pre and post-operative diagnoses were sepsis of unknown origin. On 10/26/02, aerobic and anaerobic blood cultures were positive for gram negative rods and grew bacterium klebsiella pneumoniae. The patient died on 10/26/02 of distributive shock and multisystem organ failure. An autopsy was performed at the hospital; results are pending. A section of formalin fixed liver was submitted to the CDC for evaluation of hepatic failure and suspected Yellow Fever. This report was previously submitted to VAERS by the reporter. This case is closed.  Reported on 02/27/2003: Follow-up #1 correspondence received on 02/11/2003- A pathology report received from the CDC indicated that Immunohistochemical (IHC)tests using a two-step indirect immunoalkaline phosphatase technique were performed.  The primary antibodies used in the tests include a monoclonal mouse anti-yellow fever virus D-17 strain antibody* and a polyclonal rabbit anti-K pneumoniae antibody.  Appropriate positive and negative controls were run in parallel.  No immunohistochemical staining of yellow fever virus antigen was found in multiple organs, including liver, lung, heart, spleen, kidney and lymph node.  Abundant and widespread antigens were present in mononuclear phagocytic cells and mesenchymal cells of these organs, including liver.  In comparison, smaller amounts of antigen were observed in hepatocytes.  The distribution of viral antigen is different from the pattern seen in fatal wild-type yellow fever virus infection, in which viral antigens are usually present in hepatocytes and Kupffer cells and never in our experience seen outside the liver.  Electron microscopic examination of spleen and lung tissues revealed cells with foci of smooth membrane vesicles compatible with flavivirus replication complexes.  The viral nature of these vesicles was further confirmed by immunogold label experiments using the same anti-yellow fever virus antibody.  In conclusion, the abundance and widespread distribution of viral antigens as well as the ultrastructural findings indicate yellow fever virus infection was a major cause of death in this case.  Confirmation with serology and molecular techniques is highly recommended. Correction of info reported 02/11/2003, Page 4; follow-up #1, line 5-6: Should have stated No immunohistochemical evidence of Klebsiella pneumonia infection was found in the heart and lung. Positive immunohistochemical staining of yellow fever virus antigen was found in multiple organs, including liver, lung, heart, spleen, kidney and lymph node. Code for death removed as it is an outcome and a MedDRA term was added for Multi organ failure. From additional info received on 09/10/2003, the U.S. military will not release autopsy results. This case is closed as no further info is anticipated. Follow up on 03/30/04: From information received at manufacturer on 01/13/03 from the CDC, it was reported that a 22 year old female was administered Fluzone SV '02-03 USP (Lot # U0983WA) IM in the deltoid and YF-VAX (Lot # U0253AA) SC in the deltoid on 10/17/02.  On 10/21/02 at 8:05AM she experienced fever, nausea, vomiting, diarrhea and mildy elevated liver function tests.  She was admitted to the medical center.  A spinal tap was performed on 10/23/02, which was within normal limits except for an elevated CSF glucose level 72.0 (normal range 40-70 mg/dl).  On 10/25/02, an exploratory laparotomy, partial colectomy, and lymph node biopsy were performed.  Pathology results showed areas of colon and ternimal ileum with mucosal acute inflammation, epithelial erosion and necrosis, as well as marked submucosal edema with acute and chronic inflammation.  The muscularis propria and serosa showed mild acute and chronic inflammation, which were interpreted as being consistent with ischemic bowel disease.  There were rare mucosal and submocusal lyphoid follicles with evidence of hemophagocytosis.  NO vascular emtoli or evidence of vasculitis were identified.  No parasites, granulomas or neoplastic changes were identified.  Colonic and terminal ileum  surgical margins were inflammed, margins viable.  The appendix showed mild acute and subacute appendicitis.  Lymph node biopsy showed marked interfollicular hyperplasia and sinus histiocytosis with hemophagocytosis, suggestive of hemophagocytic syndrome.  30cc of bile was also removed for analysis.  Pre-and post-operative diagnosis were sepsis of unknown origin.  On 10/26/02, aerobic and anaerobic blood culture were positive for gram negative rods and grew bacterium klebseilla pneumoniae.  The pt died on 10/26/02 of distributive shock and multisystem organ failure.  An autopsy was performed at the medical center, results are pending.  A section of formalin fixedliver was submitted to the CDC for evaluation of hepatic failure and suspected Yellow Fever.  This report was previously submitted to VAERS by the reporter (192477-1).  The case is closed.	Y	10/26/2002		Y	Y				N	10/17/2002	10/21/2002	4	Segs 75; Bands 15; Lymphs 5, 7.0, 2.9; Glucose 118.3, 114.9, 123, 72.0, 120; Urea Nitrogen 17.1; WBC 13.9, 3.1; Lymph % 4.5, 1.8; Gran % 88.6, 86.6; Sodium 133, 131, 132; Potassium 3.4, 3.3, 3.0; Osmolality, Calc 269, 263, 265; Albumin 3.8, 2.4; Alanine Aminotr 75, 69, 72, 85; Aspartate Amino 51, 89, 111; Alk Phos 131; MPV 11.0, 10.8; Neut % 92.7, 97.3; Chloride 96; Calcium 7.6, 7.1; Phosphorus 1.3, 2.4; Albumin 3.4, 2.8; Gamma Gluty 136, 117; Magnesium 1.4; Anion Gap 4-9; PLT 121; Mono % 0.6; Pathology results from 10/25/2002 (exploratory laparotomy, partial colectomy, lymph node biopsy): COLON, PARTIAL COLECTOMY:  Sections of colon and terminal ileus with mucosal acute inflammation, epithelial erosion and necrosis, marked submucosal edema with acute and chronic inflammation.  The muscularis propria and serosa show mild acute and chronic inflammation, which are consistent with ischemic bowel disease.  There are rare mucosal and submucosal lymphoid follicles with evidence of hemophagocytosis.  No vascular emboli or evidence of vasvulitis were identified.  No parasites, granulomas or neoplastic ohanges were identifed.  Colonic and terminal ileum surgical margins were inflammed, margins viable.  The appendix showed mild acute and subacute appendicitis.  LYMPH NODE BIOPSY: Lymph node with marked interfollicular hyperplasia and sinus histiocytosis with hemophagocytosis, suggestive of hemophagocytic syndrome.  Results of autopsy on 10/28/2002: Sinus tissue: positive for light amounts of candida albicens, citrobacter freundii and chryscobacterium.  Lung tissue: no aerobic or anaerobic growth, gram stain showed no organisms.  Liver tissue: viral culture pending.  Blood Culture: gram negative rods, aerobic and anaerobic cultures grew bacterium klebaiella pneumoniae.	MIL	MIL	NONE	NONE	NONE		U200300017	1						2	Diarrhoea; Laboratory test abnormal; Liver function test abnormal; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U0983WA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|YF~SANOFI PASTEUR~U0253AA~1~SC~~YELLOW FEVER (YF-VAX)~2	USA	Results in Death	Influenza
0196777	01/24/2003	CT	66.0	66		F	01/24/2003	Patient recieved the vaccine at 11:30 am on 1/21/02 in our clinic setting. She stayed about 15 minutes with no reaction. This was her first flu shot. At 5:00 pm she developed a solid, pink, itchy rash beginning at the navel spreading to her back and then to her shoulders. She went to a local walk-in center and received p.o. benadryl, IM Steriod and methylprednisolone p.o. to take at home. At 11:00 pm she felt her throat was closing up. She went to the E.R. and was treated with two benadryls and watched for 1 1/2 hours. Symptoms subsided. She was discharged from the E.R. and was to take benadryl q 6 hours for 48 hours. She was fine until 1/22/03 in the evening and her feet broke out into a rash and were itchy. She took a benadryl and it subsided. 1/23 and 1/24 she has been fine. Please let me know any thoughts you have. I told the patient I would get back to her with any feedback you have. Would you suggest any precautions with future vaccinations? I am very interested in your thoughts. Thank you.				Y					Y	01/21/2003	01/21/2003	0		PUB	PVT	Zocor 20mg q H.S. Multivitamin p.o. Calcium p.o.	None	Elevated Cholesterol			1						1	Rash pruritic; Throat tightness	FLU3~SANOFI PASTEUR~U0921CA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0195609	01/25/2003	TN	0.3	0	.2	M	01/25/2003				Y	Y	Y	11			Y	12/07/2002	12/07/2002	0		PVT	PVT						1						2	Convulsion; Irritability; Mydriasis; Screaming	DTAP~SMITHKLINE BEECHAM~574A2~1~SC~~DTAP (INFANRIX)~2|FLU3~SANOFI PASTEUR~W0063~1~SC~~INFLUENZA (SEASONAL) (FLUZONE)~2|HEP~MERCK & CO. INC.~0830M~1~SC~~HEP B (FOREIGN)~2|PNC~PFIZER\WYETH~489468~1~SC~~PNEUMO (PREVNAR)~2	USA	Life Threatening,Hospitalisation	Influenza
0196789	01/27/2003	CA	60.0	60		F	01/23/2003	Employee reports with c/o excruciating pain on left should/arm after 10 days, post vax, with the Flu vaccine. Went on vacation and reports having pain during all that time. Denies tingling/numbing in upper extremities, redness, swelling, hematoma or rash on left deltoid or arm. Was taking Motrin with no relief. Denies trauma or injury to left arm. Called PHP with left arm pain. MD told her it was probably bursitis. Neurology referral by PMD. DX: Brachial neuritis. Pain control with Neurontin, Trileptal and Lamictal.									N	11/26/2002	11/27/2002	1	Left shoulder and axillary lateral view per employee.	PVT	UNK		NONE	NONE			1						1	Bursitis; Pain; Radiculitis brachial	FLU3~SANOFI PASTEUR~U0921AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0196790	01/27/2003	WY	65.0	65		F	01/17/2003	The pt received both pneumonia and flu immunizations in the AM. Later that day, her daughter brought her to see PHN because she was refusing to go to ER and NP's office was closed. Her left arm was marked swollen from shoulder to past her elbow and she was somewhat dyspneic. Encouraged pt to follow her daughter's suggestion of taking a Benadryl and to go to ER because of her shortness of breath. TC to her daughter and also to pt, 2 days later; she had consented to use Benadryl, continued to refuse going to the ER and symptoms subsided within 24 hours. Swelling of arm went down after a few days.									Y	10/23/2002	10/23/2002	0		PUB	PUB		NONE				1						1	Dyspnoea; Injection site reaction; Injection site swelling	FLU3~SANOFI PASTEUR~U0883AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1353L~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0196796	01/27/2003	IL	4.0	4		M	01/15/2003	Left arm was red and swollen from shoulder to elbow. Entire area was so swollen due to fluid accumulation.									Y	01/13/2003	01/14/2003	1		PUB	PUB	NONE		PCN allergy	Fever of 106F~Rotavirus (RotaShield)~~0.00~In Patient	IL03002	1						1	Injection site erythema; Injection site oedema	DTAP~SANOFI PASTEUR~U0585CA~5~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1428~4~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0343M~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0196817	01/27/2003	MI	8.5	8		F	01/23/2003	Pt developed a rash that started with red bumps at injection site and then traveled down arm and then to whole body. Total time of rash, lasted 1 week. No treatment.									Y	12/12/2002	12/13/2002	1	NONE	PVT	PVT	NONE	NONE	Sulfa allergy			1						1	Injection site rash	FLU3~SANOFI PASTEUR~4020034~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0196826	01/27/2003	CA	32.0	32		M	01/04/2003	L/H upper back of arm had a softball-sized purple ring with raised (round) red/pink center within 48 hours of vaccination. These symptoms lasted approx. 48 hours, when purple ring subsided and red/pink area remained. Area itched through the duration.									Y	12/07/2002	12/08/2002	1	NONE	MIL	MIL	NONE	NONE	PCN allergy	Similar syptoms~Yellow fever (no brand name)~~18.00~In Patient		1						1	Injection site erythema; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U0956AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~SANOFI PASTEUR~UB124AA~2~SC~LA~MENINGOCOCCAL (MENOMUNE)~1|YF~SANOFI PASTEUR~UB254AA~2~SC~RA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0193620	01/28/2003	WA	54.0	54		M		Dizzy, weak and flushed for 2-3 minutes after vaccine until the next AM. 24 hour duration of symptoms.									Y	10/24/2002	10/24/2002	0		PUB	UNK	Procardia; Provera; oxycodone; Zantac; Potassium	NONE	NSAIDS sensitivity			1						2	Asthenia; Dizziness; Flushing	FLU3~PFIZER\WYETH~489588~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0196840	01/28/2003		50.0			M	01/24/2003	From faxed information received at manufacturer on 1/13/03 it was reported: this is in follow up to a report(s) previously submitted on 8/11/02 and 10/12/02. Information has been received from a registered nurse concerning a 50 year old white male who on 10/02/02 was vaccinated IM in the left deltoid with the first dose of pneumococcal vaccine 23 polyvalent (lot # 641116/1160L). On 10/3/02, the patient was vaccinated IM in the left deltoid with a second dose of concomitant suspect therapy influenza virus vaccine (FLUZONE) (lot #U0911AA), which was last administered in 2001. On 10/3/02, the patient's arm became extremely swollen and painful. The registered nurse reported that the patient was instructed to seek medical attention. The patient was treated with amoxicillin trihydrate (+) clavulanate potassium (Augmentin), 500mg, acetaminphen (Tylenol) and moist heat. The patient continued to be in pain and became very weak. The patient was admitted to the hospital for three days (dates not reported, and was treated with IV antibiotics. The registered nurse reported that the patient had recovered from the experience. No further information is expected. The case is closed. A 15-day follow up report received 7/16/2003 adds: 06/25/2003: Administrative case closure (no additional info anticipated). 07/07/2003: This version was created to correct the dates that this case was previously submitted by manufacturer to 11/08/2002 and 12/10/2002 (the dates were incorrectly typed as 08/11/2002 and 10/12/2002); and to correct the lot number for PNEUMOVAX 23 in Box 14. The correct lot number is 641116/1160L. From additional info received on 7/14/03, it was reported this is an amended report. The adverse event onset date and time have been updated and the date and time of administration of secondary suspect vaccination has been updated. The case is closed, no additional info is anticipated.				Y	Y	3			Y	10/02/2002	10/02/2002	0		PUB	PVT			Fluzone was last administered in 2001.		U200300054	1						1	Asthenia; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U0911AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1160L~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0196849	01/28/2003	VA	32.0			M	01/21/2003	Urticarial rash developed several days after 3rd Anthrax vaccination.									Y					MIL	MIL	PPD/Aventis/C1257AA/ID/LFA/4 previously	NONE	NONE			1						1	Urticaria	ANTH~EMERGENT BIOSOLUTIONS~FAV067~5~SC~~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U0956AA~5~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0196850	01/28/2003	CT	60.0	60		F		Received vaccine on 10/17/02. Soreness and redness at site was noted on 10/18/02. Persistent and worsening discomfort of whole arm over neck for a couple of months. MD evaluation and Rx'd antibiotic med. Problem continued. Orthopedic evaluation on 1/21/03.				Y						10/17/2002	10/18/2002	1		OTH	UNK						1						1	Injection site erythema; Injection site pain; Neck pain	FLU3~EVANS VACCINES~E35472HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0196852	01/28/2003	CA	37.0	36		M	01/22/2003	Pt came in on 1/8/03. States about 3 days after Flu shot, his left arm started hurting down to the elbow. Hurts to move it and can't sleep on the left side. Says arm was slightly swollen for 2 days after shot. He recalls no fevers. States it's difficult to lift his arm up over his head. He has soaked it in warm water and Epsom salt with no improvement. T/C, who suggested vitamin B6, 50 mg 1 q d. Pt to get some. Also, suggested to keep moving arm as much as possible. He called HD on 1/21/03 to say his arm is still the same, even with vitamin B6 used. States has no money to go see a MD.									N	12/12/2002	12/15/2002	3		PUB	PUB	Takes a One A Day vitamin	NONE	NONE			1						1	Hypokinesia; Injection site pain; Injection site swelling; Sleep disorder	FLU3~SANOFI PASTEUR~U0919AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0196854	01/28/2003	NY	52.0	52		F		Constant prolonged pain, soreness, burning, throbbing sensation, hoarseness, persistent coughing, shooting pains in arm, hand, shoulder, neck and head, etc. Also, had persistent nausea and vomiting AM and PM, problems with use of arm plus pain in fingers all through the day and night. Problems with lightheadedness, coordination and balance problems, aches, body fever 1 day, attacks of pain attacking all body parts except my buttocks. Problems with weakness, fever again, slight rash on both sides of neck, redness on front of neck, pain in lower back and kidney area, knee's throbbing and on 2 different days, I suffered some weird stinging, sort of heated pain from left arm into my whole left side neck and my left breast. I had pain right above my eyes. Constant pain medication still not helping. Constant blurry vision and burning sensation in both eyes. (Going to make eye clinic appt to have eyes checked). My joints hurt sometimes so bad that I can't walk or move.									N	10/28/2002				PUB	PUB	Zestril; Theophylline; Prilosec; Flovent; prednisone; stool softener; Serevent; Proventil as needed; Ambien; Tylenol; Neurontin; Celebrex		Multi-system sarcoidosis; asthma; thyroid problems; airway obstruction; enlarged heart	Throat sore with swelling tongue swelling, difficulty breathing~Pneumo (no brand name)~~50.00~In Patient		1						1	Arthralgia; Asthenia; Back pain; Coordination abnormal; Cough; Dizziness; Dysphonia; Headache; Joint range of motion decreased; Nausea; Neck pain; Pain; Pyrexia; Rash; Vision blurred; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0196895	01/28/2003	TX	72.0	72		F	11/12/2002	Acute back pain; possible Guillain-Barre?					Y				U	10/27/2002	11/04/2002	8		PVT	PVT			Diabetes			1						1	Back pain; Guillain-Barre syndrome	FLU3~EVANS VACCINES~E34692HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0196915	01/29/2003	VA	60.0	60		F		Discharge summary states Guillain Barre Syndrome. Medical record states ptosis.   A follow up report received 8/5/2003 adds: Final diagnosis still is Guillain-Barre Syndrome (GBS), made by a neurologist.			Y	Y	Y	4			Y	12/21/2002	01/01/2003	11		MIL	MIL						1						1	Asthenia; Cough; Difficulty in walking; Eyelid ptosis; Guillain-Barre syndrome; Hypoaesthesia; Influenza like illness; Lymphadenopathy; Malaise; Pharyngitis; Pyrexia; Rhinitis	FLU3~SANOFI PASTEUR~U0957AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0196920	01/29/2003	WI	48.0	48		F		Burning pain with administration of vaccine. Persistent discomfort in left arm with redness. Examined on 12/13/02 by MD and had a 6cm erythematous, warm area. Seen on 12/17/02 and there was no erythema evident. Full ROM.				Y					Y	12/09/2002	12/09/2002	0	NONE	OTH	PVT	Cozide, hormone, ?	NONE	Hayfever			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~EVANS VACCINES~E35462HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0196921	01/29/2003	UT	19.0	19		F	11/20/2002	Pt stated she had a mild stomach to eggs as a child. After 5 minutes, came back to say she felt a tightening in her throat. Chlorpheniramine tab given. Pt with parents. Instructed to watch for increased signs and symptoms of difficulty breathing and go to ER if worsening; T/C pt at home.									U	11/20/2002	11/20/2002	0		OTH	PVT						1						1	Throat tightness	FLU3~EVANS VACCINES~E34692HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0196934	01/29/2003	IL		53		M	01/23/2003	The following day I had mild stomach cramps and chills.									Y	01/07/2003	01/08/2003	1	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Abdominal pain; Chills	FLU3~SANOFI PASTEUR~U0906BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0530AA~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0196947	01/29/2003	DE	27.0	27		M	01/22/2003	Sharp shooting pain in left arm since typhoid injection two weeks ago.									N	01/09/2003	01/09/2003	0		MIL	MIL	NONE	NONE	NONE			1						1	Injection site pain	FLU3~SANOFI PASTEUR~4020032~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~SANOFI PASTEUR~U1073~3~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0196960	01/30/2003	WI	52.0			M	01/27/2003	From information received via fax at manufacturer on 1/20/03, it was reported that a 52 year old male received FLUZONE UNSP on an unspecified date. Reportedly, the patient developed transverse myelitis (unknown date of onset) and was hospitalized. An MRI and lumbar puncture were performed, but no results were available at the time of this report. The patient's recovery status was reported as not recovered. Additional information was received at manufacturer on 1/23/03 from the reporting physician. He reported that the patient received Fluzone, but he did not administer the product and does not know when the patient was vaccinated. The physician saw when he was admitted to the hospital on 1/17/03. At that time the patient had been having symptoms for approximately 2.5 months. The reporter does not have access to the patient's medical records at this time. No further information was provided.  Follow up on 07/07/2003: From additional information received on 06/25/2003 and 06/30/2003, it was reported that the patient was treated by the reporting physician in the emergency room.  The physician does not have access to the patient's medical records.  The patient experienced transverse myelitis following the administration of Fluzone on an unspecified date.  It was previously reported that the patient also had transverse myelitis at the time of vaccination, however this was reported as being incorrect by the physician's office nurse.  No further information is anticipated, this case is considered closed.					Y				N				MRI, lumbar puncture were performed (no results available at the time of this report).	OTH	OTH		Transverse myelitis	NONE		U200300044	1						1	Myelitis transverse	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0196963	01/30/2003	SC	69.0	69		F	10/30/2002	Pneumonia RA-Redness from RA to R elbow, felt hot, minimal amount of swelling. At 17:00, it got hotter and took Benadryl and applied ice pack and it felt better but area remained hot and about the same amount of swelling. The next day, it started itching. Took Benadryl before bed, the night before and took Benadryl and Tylenol about 2 days. Mid-day, the heat was less but redness remained. The swelling took about 4 days to go down. Redness stayed until the 5th day. By the 5th day, stopped Benadryl and Tylenol and then it gradually went away.									Y	10/21/2002	10/21/2002	0		OTH	PUB	Lopressor 50mg; Vitamin E and C		Allergic to grass and ?		SC0265	1						1	Injection site erythema; Injection site swelling; Injection site warmth; Pruritus	FLU3~PFIZER\WYETH~4020027~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0445M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0196973	01/30/2003	OH	28.0	28		F	01/29/2003	Pt with rash located between breasts, some diffusely inferior lymphadenopathy, papular rash associated. Pt was treated with ? dose pack and Benadryl and Allegra for seasonal allergic rhinitis. Symptoms X 5 day progression.									U	01/21/2003	01/28/2003	7	CBC	MIL	MIL	Birth control	NONE	SAR; GERD			1						1	Lymphadenopathy; Rash papular; Rhinitis allergic	ANTH~EMERGENT BIOSOLUTIONS~FAV070~1~SC~~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U0956AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~SANOFI PASTEUR~UB185AB~1~SC~~MENINGOCOCCAL (MENOMUNE)~1|RAB~SANOFI PASTEUR~U0961~1~IM~~RABIES (IMOVAX)~1	USA		Influenza
0196974	01/30/2003	MD	65.0	65		F	11/25/2002	Approximately 12 hours post vaccination of pneumovax 23, patient developed swelling left arm were pneumovax was given. Swelling extended into underarm and that night developed bloody discharge from left nipple which last a few days and seeking medical advice on 10/23.				Y					Y	10/16/2002	10/17/2002	1	Ultrasound of Breast; Needle biopsy-negative	PUB	PVT	BP meds, Aciplex, Synthroid					1						1	Haemorrhage; Oedema	FLU3~SANOFI PASTEUR~U0927AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0165M~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0196975	01/30/2003	FL	56.0	56		F	01/29/2003	Two days of chills and fever. Arm swelled a little, itched and had a rash for about 5 days on the arm.									Y	01/04/2003	01/05/2003	1		UNK	UNK						1						1	Chills; Oedema; Pruritus; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0196976	01/30/2003	MD	2.4	2	.4	M	11/25/2002	24 hours post vaccination with 1/2 dose of fluzone, child developed fever of 103F. Could not keep Tylenol down. Required visit to ER. Parents refused remaining booster dose of vaccine.				Y					Y	10/05/2002	10/06/2002	1	UNK	PUB	UNK		NONE				1						1	Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U0927AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0196977	01/30/2003	OH	28.0	28		M	01/28/2003	Generalized rash began four days ago. Redness at site <5mm, frontal sinus HA after getting shots. Rash progressively getting worse-diffuse scartina form rash.									U	01/21/2003	01/24/2003	3	TC rapid strep, CBC	MIL	MIL	NONE	NONE				1						1	Headache; Injection site hypersensitivity; Rash	ANTH~EMERGENT BIOSOLUTIONS~FAV070~1~~~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U0956AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~5330A6~3~~~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~724B6~3~~~HEP A (HAVRIX)~1|RAB~SANOFI PASTEUR~U0961~1~~~RABIES (IMOVAX)~1	USA		Influenza
0196998	01/30/2003		72.0	72		M		A report was received from a regulatory authority on 1/22/03, concerning a 72 year old male vaccinee who experienced a recurrence of pemphigoid reaction which led to hospitalization 2 days after receiving Fluvirin on 10/8/02. The vaccinee had a medical history of vitiligo phase bullous pemphigoid which was treated since July 2001 with mycophenotate mofetil and clobetasol propionate and then mycophenocate mofetil only, since March 2002 and finally stopped in July 2002. The disease was stable. There was no recurrence or pruritus. The vaccine also had a medical history of insulin dependent diabetes for 20 years and right eye cataract surgery. On 10/10/02, the vaccinee experienced a relapse of bullous pemphigoid with bulla on the right wrist and left knee. There was also significant pruritus and the vaccinee was hospitalized. The vaccinee was treated with mycophenocate mofetil, clobetasol propionate, descloradadine and hydroxyzine hydrochloride. Indirect immunofluroescence revealed circulating antibodies, anti-membrane type to bullous pemphigoid. In early December the vaccinee developed new bulla and numerous post-bullous erosions. The vaccinee also experienced oedema of the right leg. The mucous membranes were not affected. This led to the vaccinee being hospitalized again. Treatment with mycophenocate mofetil was continued along with local care and anti-histamines if required. At the end of December 2002 there was no new bullous eruption, and the erosions were on the way to scarring. There was a decrease in the oedema of the right leg. The vaccinee had not recovered at the time of the report. Laboratory data revealed important glomerular hematuria (urinary red blood cells 385 mega/l), proteinuria of 2.32 g/l and hypochromic, microcytic anemia 101 g/l with anisocytosis and poikilocytosis. The opinion of the nephrologist and a haemotologist is pending. The reporter has assessed the relationship of the vaccine to the recurrence of pemphigoid reaction as possible and there was insufficient information to determine the reporters causality assessment to the haematuria.  Follow up on 05/05/2003: A follow up report was received from the regulatory authority giving haematology results and the nephrologist's opinion.  the vaccinee was diagnosed with renal problems in 1984 with a proteinuria of 1.13 g/L.  A renal biopsy revealed at that time IgA nephropathy with 40% sclerosed glomeruli and interstitial fibrosis compatible with Berger's disease for a diabetic patient.  The vaccinee is currently showing no deterioration in renal function (lower limit for his age).  Renal echography shows normal size kidneys, well differentiated and without dilatation.  Renal doppler showed no anomaly.  There is criteria for glomerular nephropathy as there was high albuminuria and microscopit haematuria in strip.  The nephrologist found it difficult to be connect the current proteinuria of 2 g/L only with the vaccinee's Berger's nephropathy.  The cause of the glomerular hawmaturia and anemia was due to persistence of hypochronic, microcytic anemia with normal serum iron and high ferritin.  Haemoglobin was at 105 g/L and mean corpuscular volume (MCV) was 61 fl. No marrow karyotype or myelogram was performed as the vaccines had no history of thrombopenia or white cell abnormalities.  As the vaccinee is North African and has a sister with microcytic anaemia tests for thalesomia are planned.  Results are not yet available.  On 03/31/2003 there were scars on the trunk and upper limbs with post-bullets erosions on the left lower limb.  The vaccinee experienced 1 or 2 bullae every 2 days on this same limb.  The vaccinee was being treated with corticotherapy, 40g/day and mycophenocate mofetil 2 g/day at the time of reporting.					Y					10/08/2002	10/10/2002	2	FBC - hypochromic microcytic anaemia with anisocytosis and poikilocytosis; Indirect immunofluroescence - circulating antibodies positive for anti-membrane type Bullous Pemphigoid; Red blood cells in urine - 385; Proteinuria - 2.32	UNK	UNK	Concomitant drugs not reported.		Bullous Pemphigoid; Vitiligo phase; Insulin-dependent diabetes for 20 years; Right eye cataract surgery		PJP200300038	1						1	Anisocytosis; Haematuria; Microcytic anaemia; Oedema peripheral; Pemphigoid	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0197045	01/30/2003	CA	42.0			M	01/30/2003	3 week h/o left arm pain  beginning as radial nerve pain and generalizing.  Onset few days after flu  shot. MRI pos bilat brachial plexitis L>R (verbal report). Unable to sleep at night yesterday started vicodin No evidence of paralysis. Clinic deferred recommendation re: steroids and recommended				Y					U				Lab:         ESR 6         HCV Ab negative          ALT 69         Total protein 7 albumen 4.4	PUB	PUB	aspirin prn	none documented	unknown			1						1	Neuralgia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0197011	01/31/2003	MI	0.5	0	.5	M	01/03/2003	Parent called clinic on 1/3/03 to report ongoing symptoms for child that began on 12/26/02 around 22:00. Child developed blotches-red on both thighs that spread to arms, feet, neck, chest and back. Child had an axillary temperature of 101.4F. Parent reports both eyes and lips were bright red. On the 27th, the rash on feet became bumpy. Extremities were swollen, itchy and hard. Physician recommended Tylenol and Benadryl. On the 28th, child was taken to the ER when child's eyes were bloodshot and lips were red and bleeding. Child was given drops for eyes to prevent infection. Temperature decreased but redness and swelling in extremities continued throughout 1/3/03. T/C to mom on 1/6/3; child doing much better. Swelling and redness down but fingertips are peeling.				Y					N	12/16/2002	12/26/2002	10	On 12/28/02 at ER, had blood drawn and cultures were negative.	PUB	PUB	Vitamins; Poly-Vi-Sol	NONE	NONE		MI2003001	1						1	Erythema; Mouth haemorrhage; Ocular hyperaemia; Oedema peripheral; Pruritus; Pyrexia; Rash macular; Skin exfoliation	DTAP~GLAXOSMITHKLINE BIOLOGICALS~576A2~3~IM~RL~DTAP (INFANRIX)~1|FLU3~PFIZER\WYETH~4020037~1~IM~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0197012	01/31/2003	IA	34.0	34		F	11/08/2002	Flu shot given at approx. 11:10. At 11:50, noticed nose, then eyes and then mouth began to itch. Notified pt's MD. Benadryl 50mg, IM, given at 12:45. Mouth still itched at 13:30. Taker to ER for evaluation and discharged. On 11/7/02, client back to work on 11/6/02.				Y					U	11/05/2002	11/05/2002	0	UNK	PUB	UNK		NONE	Sulfa allergy			1						1	Pruritus	FLU3~EVANS VACCINES~E31952GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0197013	01/31/2003	CA	0.8	0	.9	M	01/17/2003	Had IZ's about 09:00. Developed hives about 18:00. No respiratory symptoms or oral lesions. Most of the hives were on left leg, increasingly spread on to whole body. On examination: erythematous wheals on extremities/trunk; CTA (B)-all clear.									U	01/17/2003	01/17/2003	0		PVT	UNK		NONE	Asthma			1						1	Urticaria	FLU3~PFIZER\WYETH~4020034~1~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~5361A2~3~IM~RL~HEP B (ENGERIX-B)~1|HIBV~SANOFI PASTEUR~UA741AA~3~IM~LL~HIB (ACTHIB)~1	USA		Influenza
0197014	01/31/2003	UT	31.0	31		F	11/12/2002	Flu shot given on 11/12/02 at 11:15. Pt returned at 11:25 complaining of throat being tight, a burning feeling in ears and neck and dizzy. Chlorpheniramine 8mg was given. Vital signs were stable. Pt states I feel better and returned to work in this bldg at 11:37.									Y	11/12/2002	11/12/2002	0		OTH	UNK		NONE				1						1	Dizziness; Ear pain; Neck pain; Throat tightness	FLU3~PFIZER\WYETH~4020036~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0197015	01/31/2003	DC	28.0	28		F	11/25/2002	After injection with influenza vaccine, noticed erythema around site of injection. Shortly thereafter, noticed hive across upper back. Resolved on it's own.									Y	11/22/2002	11/22/2002	0	NONE	OTH	OTH	Nordette	NONE	NONE			1						1	Injection site erythema; Urticaria	FLU3~SANOFI PASTEUR~U0929AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0197052	01/31/2003	NY	36.0	36		F	01/31/2003	Employee received vaccine at work on 10/28/02. Employee came to work 10/30/02 with complaint of edema and pain rt arm a few hours after pnuemococcal vaccine. On inspection sig. edema with sl increase pinkness noted from just below elbow rt arm up to neck/shoulder area. Saw PMD 10/30/02 and put on Medro-dose pack. On 11/1/02 spoke with employee and observed sig decrease in edema in the arm in general but elbow remains edematous but is improving. 11/4/02 spoke with employee and asymptomatic except mild tenderness.				Y					Y	10/28/2002	10/28/2002	0	N/A	PVT	PVT	Elavil 100mg qd Celebrex 200mg bid Yasmin 250mg qd Lortab 5mg prn pain usually bid	denies	Allergic to Procadia and Erythromycin- both cause hives Hx Irritable Bowel Syndrome and is currently being worked up for Mitochondrial Miosis			1						1	Erythema; Oedema	FLU3~SANOFI PASTEUR~U0904CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0376M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0197062	02/01/2003	CA	30.0	30		M	02/01/2003	Within 12 hours of vaccination, noticed lathargy, increased fever, and development of a red rash surrounding the injection site.  Rash increased bilaterally to include posterior scapular, humeral, radio-ulnar regions along with rash at the dorsal digital region of the hand extending between the fingers.				Y					U	01/21/2003	01/21/2003	0		MIL	MIL	none	none	none			1						1	Injection site erythema; Injection site rash; Lethargy; Pyrexia	FLUX~UNKNOWN MANUFACTURER~PMC UO984AA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TYP~SANOFI PASTEUR~PMC UI073~1~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0197077	02/03/2003	OK	63.0	63		F	01/23/2003	Pt states that the right arm, where she received her Flu vaccine, started to hurt about 4 hours after the injection. The pain was so severe, it kept her up all night and the next day, she couldn't move the affected arm and had severe pain. MD advised her to use warm compresses. Pt is unable to take NSAIDS.										01/22/2003	01/22/2003	0		PVT	PVT	Albuterol; Endocet; Captopril; Theophylline; Lasix; Atrovent; KT		Allergy to PCN; Dx'd HTN; Asthma; History of CABA 2001			1						1	Hypokinesia; Injection site pain; Injection site reaction; Insomnia	FLU3~PFIZER\WYETH~4020018~1~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0955M~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0197125	02/03/2003	MS	73.0	73		M	01/31/2003	Fever greater than 101 degrees F, chills, shortness of breath, Hospitalized 10/11/02 through 10/16/02 and 10/19/02 through 10/24/02. Death certificate received on 2/19/2003 indicates end stage COPD as the cause of death.	Y	10/24/2002		Y	Y	12			N	10/09/2002	10/10/2002	1	none	PVT	PVT	prednisone, albuterol,hytrin, xanox,fosomax, axid, icar-c, roxcodore	COPD	COPD, lung cancer, hypertension		MS03005	1						1	Chills; Dyspnoea; Lung disorder; Pyrexia	FLU3~SANOFI PASTEUR~UO908AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0197135	02/04/2003	MO	80.0	80		F		Dysphagia; Odynophagia				Y	Y	2			Y	10/01/2002	10/04/2002	3		PVT	PVT		NONE	Type II Diabetes; Hyperparathyroid; HTN; Comp Fx			1						1	Dysphagia; Odynophagia	FLU3~SANOFI PASTEUR~U0888AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0197145	02/04/2003	VA	34.0	33		M	01/27/2003	Lt arm swelling and redness in biceps and triceps (shoulder to elbow).				Y					Y	01/08/2003	01/09/2003	1		MIL	MIL	PPD/Aventis/C1115AB/SC/LFA	soreness in arm	Seasonal allergies; GERD			1						1	Injection site erythema; Injection site swelling	ANTH~EMERGENT BIOSOLUTIONS~FAV064~2~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U0957AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0197147	02/04/2003	TN	48.0	48		M	01/13/2003	20 min after vaccine pt with SOB and nearly collapsing. He was wheezing. As directed by a physician 1 mg epinephrine along with 50 mg of Benadryl given. Relief was obtained, the with chest pain. IV started then 125 mg Solu-Medrol. Chest pain resolved two to three minutes. Paramedics arrived and he was transferred to Erlanger Hospital for observation.				Y					Y	12/02/2002	12/12/2002	10		PVT	PVT	NONE	Check-up; pain mgmt	NKDA; COPD; Asthma; Anxiety; Alcoholism		TN03002	1						1	Chest pain; Dyspnoea; Syncope; Wheezing	FLU3~SANOFI PASTEUR~U0950AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0197154	02/04/2003	WA	35.0	35		F	11/07/2002	About 10 min after vaccine, arm began to ache from shoulder to wrist. Progressed to severe pain (7/10) X 36 hours, gradually improved. Some tenderness with palpation remains at time of report.									Y	11/04/2002	11/04/2002	0		PUB	UNK	PPD/C0983AA/ID/LFA/1/03/2002	Slightly sore throat	Betadine; Cipro			1						1	Pain	FLU3~SANOFI PASTEUR~U0920AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0197155	02/04/2003	WA	36.0	36		M	01/24/2003	Approximately 4-6 hours after immunization, noted edema, erythema to deltoid (lt). After 24 hours noted superficial erythematous streaking of the skin with lymph node enlargement and tenderness (lt) axillary. Fever 99.6F on 1/24. Symptoms hadn't worsened and was examined with recommendation to cold compress and anti-inflammatory prn. On 1/28/03 TC from pt - symptoms resolved.				Y					Y	01/22/2003	01/22/2003	0		PUB	PUB		NONE	UNK			1						1	Injection site erythema; Injection site oedema; Lymphadenopathy; Pyrexia; Skin striae; Tenderness	FLU3~SANOFI PASTEUR~U0919AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~720A4~1~IM~RA~HEP A (HAVRIX)~1|PPV~MERCK & CO. INC.~0955M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0197156	02/04/2003	CA	51.0	51		F	01/23/2003	+ redness, swelling of rt arm, hand, with decreased ability to move rt arm and numbness, tingling in rt hand X 6 days. Seen in Clinic 2 days after vaccine given, pt stated vaccination was 50% better. Treated with Zyrtec.									Y	10/22/2002	10/22/2002	0	NONE	PUB	PUB	Synthroid	NONE	allergy - timerosal; epoxy; caine mixes		CA020110	1						1	Erythema; Hypoaesthesia; Hypokinesia; Swelling	FLU3~SANOFI PASTEUR~U0934BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0172M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0197157	02/04/2003	CA	59.0	59		U		Local area erythematous, warm to the touch.									Y	12/30/2002	12/31/2002	1		OTH	PVT						1						1	Feeling hot; Injection site erythema	FLU3~SANOFI PASTEUR~U0922AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0197250	02/04/2003		52.0			M	11/17/2002	Pt received flu shot at works on Friday. That evening, pt began having hives and also chest pain. Pt eventually admitted for chest pain to r/o cardiac and GI events. No other changes in meds or food except this flu shot. Pt has had flu shot previously with no adverse effects. An event occurred that contributed to or resulted in temporary harm to the pt and required treatment or intervention.				Y	Y				U	11/15/2002	11/15/2002	0		UNK	UNK						1						1	Chest pain; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0197268	02/05/2003	TX	53.0	53		F	11/12/2002	On 11/8/02, at 16:05, client contacted me and gave me a verbal report of the signs and symptoms she experienced after she received the Influenza vaccination on 11/4/02. The client reported the following: itching, hives, swollen tongue and blisters on lips and tongue which started on 11/5/02 and lasted until 11/8/02. She stated that she also had some difficulty breathing. On 11/8/02, went to ER because of increased difficulty breathing. Dx'd as an allergic reaction and they gave her a shot and 2 pills, and also a prescription for Benadryl 50mg po q 6 hrs. On 11/8/02, she stated I am doing better, no hives, no fever, my tongue is decreased by 75% and my swallowing and breathing is better.				Y					Y	11/04/2002	11/05/2002	1		OTH	PVT	NONE	NONE	NONE			1						1	Dyspnoea; Hypersensitivity; Oral mucosal blistering; Pruritus; Tongue oedema; Urticaria	FLU3~SANOFI PASTEUR~U0955AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0197269	02/05/2003	CA	56.0	56		F	01/12/2003	Tingling down to fingers immediate on injection now has no grip, unable to raise L arm or to take off pull over shirt.				Y					N	11/06/2002	11/06/2002	0		PUB	PUB	Premarin	NONE	NONE		CA020111	1						1	Asthenia; Joint range of motion decreased; Paraesthesia	FLU3~SANOFI PASTEUR~U0919AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0197304	02/05/2003	HI	5.0	5		F	02/04/2003	Hives, facial swelling that improved with Benadryl.									Y	02/03/2003	02/03/2003	0	NONE	PVT	PUB	Tylenol	NONE	Asthma			1						1	Swelling face; Urticaria	DTAP~SANOFI PASTEUR~U0849DA~5~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U0885AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0529M~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0197342	02/05/2003	NY	75.0	74		F	02/05/2003	My mother received the flu shot on October 4, 2002 and two days later was having problems walking.  This progressed until the end of Dec. when she became sick and dehydrated and had double vision. The 60 day follow up states pt is in intensive care with encephalitis and as of today is not responding well.			Y					Y	N	10/04/2002	10/06/2002	2	She ended up being diagnosed with encephalitis and vertigo.	PUB	PVT		none	thryoid and high cholesterol;Osteoarthritis, degenerative joint disease	encephalitis~Influenza (Seasonal) (no brand name)~~75.30~In Patient		1						1	Dehydration; Difficulty in walking; Diplopia; Encephalitis; Vertigo	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Disabling	Influenza
0197345	02/05/2003	NY	42.0	42		F	02/05/2003	Shot was given up high on my right shoulder. Soreness from shot continued. 3/14/00: I discussed pain in shoulder with Dr.  while in the office for other purpose-he thought immunization might have hit the bursas in my right shoulder. Tried 3 ibuprophin twice daily in Sept/Oct 2001.  10/29/01: Dr. referred me to physical therapy for right should pain.  11/16/01-12/27/01: went to physical therapy.  The therapist suggested that there might be other problems beyond what therapy could do for me.  1/21/02: x-ray of right shoulder. 2/4/02: Dr.  diagnosed osteoartritis in my right shoulder and gave me my 1st cortisone shot.  11/11/02: Returned to Dr. and received a 2nd cortosone shot.  Shoulder is still painful from the arthitis in the same location as I had received the flu shot. The follow up states the date of the flu immunization is incorrect in the letter and on the authorizations for release of info. It should be 10/8/99, not 10/8/02. I changed the date. I didn't provide the following info when I filed the original report. I was taking a prescription medication for cyclobenzaprine 10mg after seeing physician's assistant. This was also for the right shoulder (muscle strain). I received physical therapy from 11/16/01-12/27/01. I didn't give you the name of the provider in the original report. I'm mailing the authorizations for release of info today. Degenerate AC joint change.								Y	N	10/08/1999	10/08/1999	0		PUB	PVT	Birth Control Pills; Claritin; Flonase	N/A	Allergies:  Seasonal, dust mites, mold, tree/grass pollens			1						1	Arthritis; Arthropathy; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0197381	02/06/2003	DC	34.0	34		M	02/06/2003	SORENESS AND REDNESS (APPROX 5 IN DIAMETER AROUND INJECTION SITE) CONTINUING AFTER 3 1/2 DAYS SINCE ADMINISTRATION.									N	02/03/2003	02/03/2003	0		MIL	MIL	NONE	NONE	NONE			1						1	Injection site erythema; Injection site pain	ANTH~EMERGENT BIOSOLUTIONS~FAV 067~4~IM~LA~ANTHRAX (BIOTHRAX)~1|FLU3~PFIZER\WYETH~4020032~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0197385	02/07/2003	WI	89.0	89		M	01/17/2003	Pt received influenza vaccine on Tuesday and complained of chills and lethargy the following afternoon. Family was instructed to take him to a doctor as he had a terminal illness, but pt refused to go as he feared he would be placed in a nursing home. Nurse contacted family today and again encouraged he go to hospital as he was not eating, bed-bound and less responsive. He died when he got to hospital 1/17/03. Death certificate received on 3/5/2003 indicates CHF as the cause of death.	Y	01/17/2003		Y					N	01/14/2003	01/14/2003	0		OTH	PUB	Ascriptin, Lasix, Lanoxin, Flomax, Tylenol	c/o of chills - was in a w/c	PT was terminally ill, was not expected to live > Oct. 02.  CHF, renal insufficiency			1						1	Anorexia; Cardiac failure; Chills; Lethargy	FLU3~EVANS VACCINES~312026A~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0197401	02/07/2003	SC	75.0	75		F	01/28/2003	Complained of left arm pain after flu shot; was admitted to hospital due to questionable stroke. Received cardiac/pacemaker work-up (negative). Then saw doctor in pain clinic and was referred to neurologist. Rx for PT, Trileptol and Darvocet. Still having pain. Thinks shot was given too high. The 60 day follow up residual weakness, numbness with occasional flare-ups of pain related to certain positions. Pt feels that flu shot was given too high in her deltoid muscle. Neurology report shows encapsulitis.  Follow up 9/10/04: Pt doing so well, just had battery replaced on pacemaker. No longer a volunteer at this hospital. Discharge summary states TIA, facial paralysis, urinary tract infection, degenerative joint disease, abdomenial pain. msv				Y	Y	3			Y	10/21/2002	10/21/2002	0	X-ray negative; Labs negative; Venous U/S negative Discharge summary states CT abnormal, bacterial infection. msv	MIL	OTH	Inderal; Insulin	NONE	Pacemaker; DM; HTN Discharge summary states coronary artery disease, congestive heart failure, urinary tract infection. msv			1						1	Abdominal pain; Arthropathy; Asthenia; Bacterial infection; Cerebral ischaemia; Cerebrovascular accident; Facial palsy; Hypoaesthesia; Injection site pain; Laboratory test abnormal; Urinary tract infection	FLU3~SANOFI PASTEUR~U0908AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0197407	02/07/2003	CA	48.0	48		M	01/10/2003	Fever, chills, sweats, body aches, left arm red, swelling & pain.				Y					U	01/08/2003	01/09/2003	1	NONE	PVT	PVT	Glucophage	Diabetes mellitus	PCN, codeine			1						1	Chills; Hyperhidrosis; Myalgia; Oedema; Pain; Pyrexia; Vasodilation procedure	FLU3~SANOFI PASTEUR~U0953AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1027M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0197408	02/07/2003	CA	49.0	49		F	11/15/2002	Four hours later immediate: back pain, malaise, arm sore. 24 hrs later: rash on face and neck, arm sore. Took ibuprophen and Tylenol.									U	11/14/2002	11/14/2002	0		OTH	PVT		NONE	sulfa, Compazine, Kanomycine, Sporins	Swollen site~Influenza (Seasonal) (no brand name)~1~44.00~In Patient		1						1	Back pain; Injection site pain; Malaise; Rash	FLU3~SANOFI PASTEUR~U0913AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0197409	02/07/2003	SC	61.0	61		F	01/28/2003	C/O pain L arm post flu shot. Did not report for three months D/T she thought it would get better. Sending for neurology consult. Took Advil without relief. Thinks shot was given too high.				Y					N	10/21/2002	10/21/2002	0	NONE	MIL	OTH	Zocor, Estratest, Corzide, Detrol LA, Serzone	NONE	HTN, depression, high chol.			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U0908AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0197410	02/07/2003	SC	50.0	50		F	01/28/2003	C/O L arm pain post flu shot. Saw family MD D/T knot on side of neck L. Ordered Sulfa x 10 days. Refused neurology consult-took Medrol dose pack with relief. Thinks shot was given too high.				Y					Y	10/21/2002	10/21/2002	0	Vascular ultrasound-neg	MIL	OTH	Lotensin, Prozac, HCTZ, Celebrax, Soma, Zyrtec	NONE	HTN, high chol, depression			1						1	Injection site pain; Subcutaneous nodule	FLU3~SANOFI PASTEUR~U0908AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0197411	02/07/2003	SC	29.0	28		F	01/28/2003	C/O R arm pain post flu shot. C/O decreased ROM. Took Advil without relief. Saw family MD-given stronger anti-inflammatory. Thinks show was given too high.				Y					Y	10/21/2002	10/21/2002	0	NONE	MIL	OTH	Effexor, Atenolol, Cenestin, Bextra	NONE	Cervical neck inj-requiring surgery			1						1	Injection site pain; Joint range of motion decreased	FLU3~SANOFI PASTEUR~U0908AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0197412	02/07/2003	SC	59.0	59		F	01/28/2003	C/O L arm pain post flu shot. C/O decreased ROM and pain into shoulder and neck. Took Advil without relief. Refused Medrol dose pack. Referred to neurologist. Ordered Mobic and MRI, labs. Never had MRI. Thinks shot was given too high.				Y					Y	10/21/2002	10/21/2002	0	MRI-neg, labs-neg.	MIL	OTH	NONE	NONE	NONE			1						1	Injection site pain; Joint range of motion decreased; Neck pain	FLU3~SANOFI PASTEUR~U0908AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0197413	02/07/2003	SC	55.0	55		F	01/28/2003	C/O severe pain during flu shot inj and immediately burning/throbbing down arm. Sent to MD-Rx for Pucocet. Referred to neurologist. Dx=axillary neuropaxic inj. Rx-pt and purcocet. Thinks show was given too high.				Y					Y	10/24/2002	10/24/2002	0	NONE	MIL	OTH	Premarin, Zoloft, Zyrtec	NONE	Asthma, L rotator cuff tear in past.			1						1	Injection site inflammation; Injection site pain	FLU3~SANOFI PASTEUR~U0908AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0197414	02/07/2003	SC	22.0	22		F	01/28/2003	C/O L arm pain post flu shot. Took Motrin without relief. Referred to neurologist. Dx=myalgia. Ordered PT with relief. Thinks shot was given too high.				Y					Y	10/21/2002	10/21/2002	0	NONE	MIL	OTH	NONE	NONE	NONE			1						1	Injection site pain; Myalgia	FLU3~SANOFI PASTEUR~U0908AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0197415	02/07/2003	SC	47.0	49		F	01/28/2003	C/O L arm pain post flu shot. Took Celebrex, Advil, Medrol dose pack without relief. Pt 2x weekly with Biofreeze at imtophoresis. Did not want to see neurologist. Thinks shot was given too high.				Y					N	10/21/2002	10/21/2002	0	NONE	MIL	OTH	Singulair, Allegra, Lipitor	NONE	Lung problems, ortho surgeries			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U0908A~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0197416	02/07/2003	SC	51.0	51		F	01/28/2003	C/O L arm pain post flu shot. C/O decreased ROM and catch. Tried Motrin and Medrol dose pack without relief. Referred to neurologist. Ordered Vioxx, Neurontin, MRI and PT. Thinks shot was given too high.				Y					Y	10/21/2002	10/21/2002	0	X-ray-neg, MRI-neg.	MIL	OTH	Premphace	NONE	Various surgeries			1						1	Injection site pain; Joint range of motion decreased	FLU3~SANOFI PASTEUR~U0908AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0197417	02/07/2003	SC	55.0	55		F	01/28/2003	C/O L arm pain post flu shot. C/O numbness/tingling and decreased ROM. Took Advil without relief. Medrol dose pack without relief. Referred to neurologist. Ordered Bextre, Neurontin and PT> Stopped taking Neurontin. Thinks shot was given too high.				Y					Y	10/21/2002	10/22/2002	1	MRI-neg	MIL	OTH	Premarin, Lipitor	NONE	DM, HTN			1						1	Hypoaesthesia; Injection site pain; Joint range of motion decreased; Paraesthesia	FLU3~SANOFI PASTEUR~U0908AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0197418	02/07/2003	SC	48.0	47		F	01/28/2003	Complained of left arm pain after flu shot. Took Tylenol/Motrin/Aleve for relief. Saw MD. Rx for Naprosyn, PT, and x-ray. Told she has tendonitis. Thinks shot was given too high.				Y					N	10/21/2002	10/21/2002	0	X-ray negative	MIL	OTH	Ambien; Protonix; Aciphex	NONE	NONE			1						1	Pain; Tendonitis	FLU3~SANOFI PASTEUR~U0908AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0197419	02/07/2003	SC	46.0	46		F	01/28/2003	Complained of left arm pain after flu shot. Took Advil for relief. Took Medrol dose pack for relief. Referred to neurologist. Diagnosed with Brachial Plexitis and ordered P. T. , Vioxx, Iontophoresis with Dexamethasone. Back to work 12/11/02 (full duty). Referred to orthopedist and scheduled EMG study. Thinks shot was given too high.				Y					N	10/24/2002	10/24/2002	0	X-ray negative; MRI negative	MIL	OTH	Xanax; Fiorinal; Vitamin E; Multivitamin	NONE	NONE			1						1	Injection site inflammation; Injection site pain	FLU3~SANOFI PASTEUR~U0908AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0197420	02/07/2003	SC	56.0	56		F	01/28/2003	Complaints of shoulder pain after flu shot and couldn't sleep due to pain. Also complained of limited ROM. Rx for Medrol dose pack for relief. Rx for PT 2 times weekly and Bextra for relief. Referred to neurologist; ordered more PT and Prednisone. Thinks its frozen joint. Referred to orthopedist. Giving cortisone injections. Also getting iantophoresis in PT. Thinks shot was given too high.				Y					N	10/21/2002	10/21/2002	0	MRI normal	MIL	OTH	Celexa; Wellbutrin; Klonopin; Restoril; HCTZ	HTN, Depression, Back Problems L4-5	HTN, Depression, Back Problems L4-5			1						1	Arthropathy; Joint range of motion decreased; Shoulder pain	FLU3~SANOFI PASTEUR~U0908AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0197421	02/07/2003	SC	48.0	47		F	01/28/2003	Complaints of right arm pain, numbness and tingling after flu shot. Rx of Percocet and Ibuprofen and told to rest. Missed several days of work due to could not lift arm. Referred to neurologist. Dx of ? fascitis. Ordered PT with iontophoresis, Relafen, Protonix, Neurontin. Also scheduled EMG study. Patient now on Celexa. Thinks shot was given too high.				Y					Y	10/24/2002	10/24/2002	0	MRI normal; Arm X-ray normal.	MIL	OTH	NONE	NONE	NONE			1						1	Hypoaesthesia; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U0908AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0197422	02/07/2003	SC	41.0	40		M	01/28/2003	Complaints of paint to right arm 2-3 days after flu shot. Also complaints of pain to right shoulder, under arm, and side of neck. Tx with Medrol dose pack with no improvement. Referred to neurologist. Tx with physical therapy for pain syndrome. Thinks shot was given too high.				Y					N	10/21/2002	10/23/2002	2	NONE	MIL	OTH	NONE	NONE	Sciatica			1						1	Neck pain; Pain; Shoulder pain	FLU3~SANOFI PASTEUR~U0908AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0197423	02/07/2003	AL	40.0	40		F	01/28/2003	Painful, swelling in left arm with itching, redness and burning, hot to touch 1/23 at night. Seen at emergency room on 1/26 and received a prescription for Prednisone 60mg a day and reduced by 10mg each day down to 10mg on day 6. Benadryl and Motrin PRN. Headache, elevated blood pressure and high heart rate; eyes were sensitive to light. Symptoms subsided after receiving Prednisone. Sight slightly tender/discolored below site.				Y					N	01/23/2003	01/23/2003	0	NONE	PUB	PUB	Metronidzaole; Prevacid; Inhaler; Cimetidine	NONE	Anansiad; Asthma; GERD; Stomach disease; HBP; Trichomonias	~Td Adsorbed (no brand name)~4~13.00~In Patient	AL0303	1						1	Headache; Hypersensitivity; Hypertension; Injection site erythema; Injection site hypersensitivity; Injection site pain; Injection site warmth; Pruritus; Skin discolouration; Thermal burn	FLU3~EVANS VACCINES~E33482HA~2~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~SANOFI PASTEUR~U0524AA~2~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0197469	02/10/2003	TX	34.0	34		M	01/26/2003	Right deltoid injection uneventful. Awoke from sleep at 02:00, the following day, with a moderately severe headache that has persisted for several hours. Also has body aches and leg cramp. No fever, nausea or vomiting. Injection site normal.									Y	01/25/2003	01/26/2003	1		MIL	MIL	NONE	NONE	NONE			1						1	Headache; Muscle spasms; Pain	ANTH~EMERGENT BIOSOLUTIONS~FAV070~2~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U0983AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0197472	02/10/2003	NY	63.0	63		F	02/07/2003	Macular, papular rash on torso and bilateral arms that appeared 2 hours after receiving Influenza vaccine and a PPD.									Y	01/29/2003	01/29/2003	0	NONE	PVT	OTH	Estrace; PPD/Aventis/C1113AA/SC/LA	NONE	NONE			1						1	Rash maculo-papular	FLU3~SANOFI PASTEUR~U0931AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0197473	02/10/2003	DC	7.0			F	10/22/2002	3 wheal on right arm.									Y	10/21/2002	10/22/2002	1		MIL	MIL			Asthma			1						1	Urticaria	FLU3~SANOFI PASTEUR~U0880AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0197474	02/10/2003	SD	44.0	44		M	02/07/2003	Optic Neuritis Rt. Has seen opthomologist Neurology. Seen at clinic. IV Steroids. The 60 day follow up states optic neuritis in my right eye. My vision has not improved in 6 months. I still have optic neuritis in my right eye optic nerve. It doesn't look like the vision will come back. My night vision is very poor. Always blurry and cloudy. I received a letter from VAERS that mentioned possible compensation. I had almost $8, 000 in medical bills because of that flu shot. Do I qualify for that? Please let me know. Thanks				Y					N	10/31/2002	11/02/2002	2		OTH	PVT	Proscar, ASA	NONE	Prostate Prob. neg			1						1	Optic neuritis; Vision blurred; Visual disturbance; Optic neuritis; Vision blurred	FLUX~UNKNOWN MANUFACTURER~~5~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U0910AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0197475	02/10/2003	NY	47.0	47		M	02/03/2003	Right deltoid extensive swelling, tender, warm, erythermatris, lymphoid streaking toward pictural region. Tx: Prednizone 40mg  tape 10mg no 3D, Augemntin 875 mg  BID x 7 days.									Y	01/28/2003	01/29/2003	1	NONE	PVT	UNK	Pulimeont, Advair, Albutrol inhaler, Atrovent inhaler	NONE	Asthma			1						1	Erythema; Feeling hot; Injection site oedema; Injection site pain; Lymphadenopathy	FLU3~EVANS VACCINES~3392GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1353L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0197494	02/10/2003	CA	34.0	34		M	02/10/2003	1 week after 2nd Anthrax shot: Severe swelling of left wrist, aches in right shoulder and lower back.  Nose swollen and painful to the touch.									U	02/02/2003	02/04/2003	2		MIL	MIL						1						1	Oedema; Pain	ANTH~EMERGENT BIOSOLUTIONS~FAV069~2~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U0674AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0197597	02/10/2003	CA	81.0	81		F	02/10/2003	Radiation recall from radiation I had from breast cancer (DCIS) on Oct. 23, 2000. Very rare said my doctor and an oncologist friend.....also had flu, chills for about 24 hrs.  The Sunburn  radiation lasted about 4/5 days....Mr. Dr. suggested I take antihistamine which I did.									Y	11/15/2002			None	PUB	UNK	Tamoxifen,Nifidipine,Atenolol	none	BP under control			1						1	Chills; Condition aggravated; Influenza; Radiation injury	FLUX~UNKNOWN MANUFACTURER~No  vaccines~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0197504	02/11/2003	CO		79		F	02/05/2003	Within 2 hours, high fever, brown spot size of nickel at injection site, ache all over, stopped eating and drinking. 3 Advil for 3 hours for unrelieved pain. 2 weeks - abdominal pain and nausea. One week - chest pain and right shoulder pain.	Y	11/23/2002		Y	Y	8			N	10/29/2002	10/29/2002	0	WBC 20,000 - 40,000; Severe metabolic acidosis; Heart attack; CT Scans negative	PVT	PUB	Advil; Lomotil	NONE	Topical allergic reactions; Bypass surgery	Illness~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Abdominal pain; Anorexia; Chest pain; Injection site reaction; Metabolic acidosis; Nausea; Pain; Pyrexia; Shoulder pain; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~7+~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0197515	02/11/2003	CA	20.0	20		M	12/12/2002	PT received 0.5 cc of anthrax vaccine in left deltoid SQ, at 12 p.m. At 5:30 p.m. PT noticed his face, back, and chest had large red patches.									U	12/09/2002	12/09/2002	0	NONE	MIL	MIL						1						1	Rash	ANTH~EMERGENT BIOSOLUTIONS~FAV066~1~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~PFIZER\WYETH~4020032~4~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0197526	02/11/2003					U		Temperature 102.7F, headache, generalized body weakness for 2 days (12/28 - 12/29). Swollen on left side (injection side). Six days (12/28/02 - 1/3/03). Patien is a medical student; took augmentin 875mg po BID for ? days (prescription by his private doctor). Report this after he returned from India vacation 1/3-1/26. Reported to me on 2/6/03.									Y	12/27/2002	12/28/2002	1		PUB	OTH		NONE	UNK			1						1	Asthenia; Headache; Injection site oedema; Pyrexia	FLU3~EVANS VACCINES~E37182UA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0134M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0197527	02/11/2003	AK	43.0	43		F	01/14/2003	Vaccine given on 9/19/02 in village - was on way to Anchorage - next day arm was swollen (at deltoid area), redness, checked in with MD at clinic. pt is HIV positive.				Y					Y	09/19/2002	09/20/2002	1	NONE	PUB	PUB		HIV +	HIV +		AK200304	1						1	HIV infection; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U0885AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1351L~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0197528	02/11/2003	AK	81.0	80		F	01/13/2003	Seen by Dr on 10/30/02, Rt arm deltoid area swollen, bruised, red streaks, sore. MD said it was an immune response a good thing wait over 8 yrs before next shot  ? happened last time moderately.				Y					Y	10/28/2002	10/29/2002	1	NONE	PUB	PUB		NONE			AK200305	1						1	Cellulitis; Contusion; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U0885AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1351L~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0197529	02/11/2003	SC	45.0	45		F		Clinic called 1/14/03 and reported that the TD shot she got in her arm was red and swollen down her arm, she stated that it was painful and can not lay on the arm at night. Pt was encouraged to see PMD or ER for treatment. Follow up states: Have not received forms back from reviewing medical authority.									U	01/09/2003	01/14/2003	5		PUB	PUB	NONE	NONE	NONE		SC0303	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U0935BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0820AA~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0197530	02/11/2003	MS	73.0	73		F	01/31/2003	Pt stated on 1/28/03 she developed coldness in left leg after vaccination on 12/17/02.									Y	12/17/2002	12/18/2002	1	Nerve conductive study, EMG of left leg	OTH	PVT	hydrochlorate 25mg, Ranitidine 150mg	DJD L knee, hypertension	DJD L knee, Hypertension, allergy to tylenol #3, ASA			1						1	Feeling cold	FLU3~EVANS VACCINES~E33482HA~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0197531	02/11/2003	FL	69.0	69		F	02/02/2003	Pt rec'd the flu shot on 1/23/03, she was getting ready for bed at 10:30pm on Friday, 1/24 when she noticed a large lump-like swelling near the area of the flu shot. It was the size of half a lemon. On Sat 1/25 at 9:00am she called the Hlth Dept where she rec'd the shot and explained why she was calling and was told they would call me back, within 15 min. a Dr called and asked me about my symptoms. He told me to put ice on the area and if I was running a fever or if the area changed colors to go to the ER. He said it was too soon to think about an infection. He also mentioned something about a hematoma. On Monday went back to Hlth Dept to have someone look at the swollen area (swelling gone down somewhat) a nsg checked it out and had someone else look at it also and they agreed it looked ok to them that it did not look swollen to them. she was given a paper on the influenza shot.										01/23/2003	01/24/2003	1		PVT	UNK	Zetia 10mg, lescol XL 80 mg	NONE	Allergic to penicillin and sulfur			1						1	Injection site mass; Injection site swelling	FLU3~SANOFI PASTEUR~V0926EA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0197532	02/11/2003	IL	52.0	52		F	01/28/2003	Intense headache plus recurrent ones (back of head) nerve endings tingling (several weeks) like contact with H.D. bug killer, dizziness, slower to act, spacey , slight fever went away. headache recurrent and slowness to act. ?? No meds taken that day due to strange feeling, etc.									U	12/13/2002	12/13/2002	0		PUB	OTH	Bextra, furosemide, iopydone, singular	NONE	HBP, Sjordgen's disorder, glaucoma, COPD, dust, mole allergies			1						1	Dizziness; Headache; Lethargy; Paraesthesia; Pyrexia	FLU3~SANOFI PASTEUR~U0951AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0197562	02/11/2003	PA	54.0	54		M	02/04/2002	Diarrhea, stomach cramps, dizziness, weakness, fever.									Y	01/08/2003	01/08/2003	0	NONE	UNK	UNK			Back problems			1						1	Abdominal pain; Asthenia; Diarrhoea; Dizziness; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0197589	02/11/2003	MN	1.0	1	.1	M	02/03/2003	Per parent report - woke up around 2 a.m. with 102.6 deg., skin bright red all over, shaking, eye swelling, sent? to ER. Developed few hives on wrist and cheek, heat rash laver? extremities, feet swelling. Dx at ER with om, rash Dx viral Rx'd Zithromax. Return to normal skin color around 4:30 a.m. Temp decreased with Tylenol.				Y					Y	01/29/2003	01/30/2003	1		PVT	UNK	NONE		Innocent murmur			1						1	Face oedema; Oedema peripheral; Pyrexia; Tremor; Urticaria; Vasodilation procedure	FLU3~PFIZER\WYETH~4020037~2~IM~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|IPV~SANOFI PASTEUR~W0197~3~SC~LL~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0633M~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~491183~3~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0595M~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0197594	02/11/2003	AL	42.0	42		M	02/09/2003	Pt had not eaten breakfast. Reports taken this AM. Had flu-typhoid vax administered. Upon giving IM hep A began to feel faint. Los consciousness and supported pt in chair while without consciousness. Pale. Consciousness and color returned after given sugar and .5cc epinephrine at 10:15 AM. Medic on site responded with oxygen applied right upper extremity.									Y	02/09/2003	02/09/2003	0		MIL	OTH						1						1	Dizziness; Loss of consciousness; Pallor	FLU3~SANOFI PASTEUR~U0941AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~719B6~UNK~~RA~HEP A (HAVRIX)~1|TYP~SANOFI PASTEUR~W09092~UNK~~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0197627	02/12/2003	FL	24.0	24		F	12/20/2002	Large local reaction with erythema and edema left upper arm, 10x19 cm induration, erythema, color, L > R 2 cm in circumference.				Y					Y	12/17/2002	12/18/2002	1	NONE	MIL	MIL	Depo-Provera right arm (18 sec?)	NONE	Allergy to sulfa, flacyl, artificial strawberries, sizing			1						1	Injection site mass; Injection site oedema; Injection site rash; Injection site reaction	ANTH~EMERGENT BIOSOLUTIONS~FAV065~4~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U0956AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0197643	02/12/2003	NY	1.45	1	.5	M	02/07/2003	Shots were given on Fri. 1/24/03 at 11am from Fri. into Sun my son started loosing his appetite. 1am Mon. morning he ran a high fever and started seizing and again at 9am. Medical records states cough, viral syndrome, rhinnitis, complex febrile seizure. msv				Y	Y	2			Y	01/24/2003			CBC and blood work	PUB	OTH	Pumicort, Xopenex		Asthma			1						1	Convulsion; Cough; Decreased appetite; Febrile convulsion; Pyrexia; Rhinitis; Viral infection	DTP~UNKNOWN MANUFACTURER~~UNK~~~DTP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0197644	02/12/2003	SC	3.0	3		M	02/05/2003	15cm soft warm erythematous at L thigh at injection site. sent home for observation by mom. Tx with OTC benadryl or tylenol. Return if not resolved in 2-3 days or worsens.									U	02/03/2003	02/05/2003	2		PUB	PUB		allergic rhinitis				1						1	Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~60956BA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~491165~4~IM~LA~PNEUMO (PREVNAR)~1	USA		Influenza
0197645	02/12/2003	MS	66.0	66		F	01/03/2003	Pt started hurting after about 36 hrs. Every other day my arm, legs,head ached badly, my ears bled pt had difficulty hearing. Was seen by Dr pt Rt eardrum has a hole in it - now it is crusted with blood. Pt was Tx with antibiotics and drugs.				Y					N	12/10/2002	12/12/2002	2		MIL	MIL		NONE				1						1	Ear disorder; Headache; Hypoacusis; Pain; Tympanic membrane perforation	FLU3~PFIZER\WYETH~4020032~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0197659	02/12/2003	RI	10.0	10		F	02/04/2003	Minor erythema at both arms.									Y	01/29/2003	01/29/2003	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Erythema	DT~SANOFI PASTEUR~U0819AA~UNK~~RA~DT ADSORBED (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U0936FA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W0197~1~~LA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0197722	02/13/2003	AZ	34.0	34		M		Steven Johnson syndrome x 2 wks-inpt tx required. Discharge summary states rash.			Y						Y	01/10/2003	01/12/2003	2	Physical exam; lab tests abnormal	MIL	MIL	NONE	NONE	NONE			1						1	Laboratory test abnormal; Rash; Stevens-Johnson syndrome	DT~UNKNOWN MANUFACTURER~~UNK~~~DT ADSORBED (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~U0957AA~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0197730	02/13/2003	NY	62.0	62		F	12/03/2002	Rash on face & arms & genital area. Felt sun bound, itchy - hive like. Consult w/MD given Prednisone & Benadryl.									Y	11/12/2002	11/12/2002	0		PUB	PVT		NONE	Seasonal allergies			1						1	Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U0925AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0197731	02/13/2003		22.0	22		M	02/05/2003	After receiving immunizations, PT went pale and passed out in chair, corpsman providing care helped PT to floor. PT recovered shortly after. PT was monitored VS and 2kg. Was released after about 30 mins.									Y	02/05/2003	02/05/2003	0		MIL	MIL		NONE	NONE			1						1	Pallor; Syncope	FLU3~PFIZER\WYETH~U020032~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEPA~UNKNOWN MANUFACTURER~0710L~2~IM~LA~HEP A (NO BRAND NAME)~1|JEV~SANOFI PASTEUR~EJN207A~1~SC~RL~JAPANESE ENCEPHALITIS (JE-VAX)~1|TYP~UNKNOWN MANUFACTURER~U07042~1~IM~RA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0194231	02/19/2003	CA	52.0	52		M	12/14/2003	Encephalitis.			Y						U	11/09/2002	11/14/2002	5		UNK	UNK	Benadryl		Hep B Surface AG carrier			1						2	Encephalitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening	Influenza
0197843	02/19/2003	AZ	21.0	21		M	02/11/2003	Left elbow and forearm vesicular bulbous lesions spreading to left neck and head, spreading across midline to right forearm. No oropharyngeal lesions. No fever, chill. Good smallpox vaccine take. The pt is a 21 year old male , who received a smallpox vaccination, as well as PPD skin test, hepatitis A and B vaccines, influenza vaccine, anthrax vaccine and yellow fever vaccine on, or about Jan. 29th of this year. Two or three days ago, the pt developed left elbow and forearm vesicular/ bullous lesions. These subsequently appear on the left neck and head, and spread across the midline to involve the right forearm. The brachial areas were not reported. The pt has had no fever, chills, diarrhea, or vomiting. Infectious disease is consulted for eczema vaccinatum.					Y	2			Y	01/29/2003	02/06/2003	8	PPD test,  Skin biopsy, Electron Microscopy, DFA for VZ and HSV	MIL	MIL	PPD		Penicillin allergy		AZ0303SM	1						1	Dermatitis bullous; Vaccination complication	ANTH~EMERGENT BIOSOLUTIONS~~UNK~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~HEP A + HEP B (TWINRIX)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0197861	02/19/2003	NJ	43.0			M	03/28/2003	About 6 days after receiving flu shot, PT developed body aches, sore throat, low grade temp. Details unknown. This pt had flu vaccine in an area where they live. Information of vaccine are unavailable. Possible reaction/viral illness. Treated in MD office 11/21/2002									Y		11/16/2002		NONE	UNK	UNK		UNK	Asthma, hypertension, seafood allergies, obesity			1						1	Myalgia; Pharyngitis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0197862	02/19/2003	WA	59.0	59		F	02/05/2003	More pain than usual at inject site. Persistent pain 3.5 mts later. Site looks ok. No abnormality palpable.									N	10/14/2002	10/15/2002	1	N/A	PVT	UNK	Metoprolol, hctz, zestril	NONE	Hyzaar-rash, Tiazac - red face; HBP			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U0883AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0197863	02/19/2003	ID	6.0	6		M	01/10/2003	Intense erythema/edema of skin overlying inject site. Extended to involved entire lateral arm. No fever, no tenderness.				Y						01/07/2003	01/07/2003	0		PVT	PUB					ID03004	1						1	Erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U0950AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0197893	02/19/2003	NE	55.0	55		M	01/29/2003	Got flu shot 11/12/02. Had subsequent tremendous nasal congestion to point of creating inability to breathe through nose started Prednisone taper.									Y	11/12/2002			NONE	OTH	OTH	Gentamicin spray; Claritin D	UNK				1						1	Nasal congestion	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0197907	02/19/2003	CA	73.0	72		M	02/14/2003	Encephalitis.  A 60-day follow up report received 6/10/2003 adds no new info.  Annual follow up on 03/17/04: It is unknown if pt recovered from adverse events.			Y		Y				U	11/01/2002	12/31/2002	60		UNK	UNK	Armour thyroid, terazidsin (hytrin) casodex, lupron		Prostate cancer, hypothyroidism, shingles (2 yrs ago), bad lower back			1						1	Encephalitis	FLU3~PFIZER\WYETH~4020004~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation	Influenza
0197908	02/19/2003	CA	53.0			F	02/14/2003	Encephalitis.  A 60-day follow up report received 6/10/2003 adds no new info. Annual follow up on 03/17/04: It is unknown if pt recovered from adverse events.			Y						U		01/24/2003			UNK	UNK	Prozac		Depression			1						1	Encephalitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0197909	02/19/2003	CA	57.0			F	02/14/2003	Encephalitis. Annual follow up 03/17/04: It is unknown if pt recovered from adverse events.			Y						U		11/06/2002		A 60-day follow up received 6/10/2003 changes Patient recovered to Unknown from No (Box 9).	UNK	UNK			H/O colon CA, s/p R hemicolectomy, H/D rheumatoid arthritis			1						1	Encephalitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0197911	02/19/2003	CA	66.0	66		M	02/14/2003	Encephalitis. Fever, elthargy, alt. conscious, personality, stiff neck, somnolence, seizures, sore throat.  A 60-day follow up report received 6/10/2003 adds no new info. Annual follow up on 03/17/04: It is unknown if pt recovered from adverse events.			Y						U	12/05/2002	12/06/2002	1		UNK	UNK			NONE			1						1	Convulsion; Encephalitis; Lethargy; Musculoskeletal stiffness; Pharyngolaryngeal pain; Pyrexia; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0197912	02/19/2003	CA	68.0	68		F	02/14/2003	Encephalitis. Fever, lethargy, extreme irritability, stiff neck, somnolence. The discharge summary states contusion of skull, thrombophlebitis, altered level of consciousness, bacteruria, and meningoencephalitis.  A 60-day follow up report received 6/10/2003 adds no new info. Annual follow up on 03/17/04: It is unknown of the pt recovered from the adverse events.			Y						U	10/18/2002	10/21/2002	3		UNK	UNK			Osteoarthritis, hypothyroidism, Depression, alcohol use			1						1	Encephalitis; Injury; Irritability; Lethargy; Musculoskeletal stiffness; Pyrexia; Somnolence; Stupor; Thrombophlebitis; Urinary tract infection	FLUX~UNKNOWN MANUFACTURER~U0949AA~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0197913	02/19/2003	CA	72.0	72		M	02/14/2003	Encephalitis. Lethargy, alt. conscious, personality, extreme irritability, somnolence, seizures. A 60-day follow up report received 6/10/2003 adds no new info. The discharge summary states CVA.  Annual follow up on 03/17/04: It is unknown if the pt recovered from the adverse events.			Y		Y				U	11/14/2002	11/30/2002	16		UNK	UNK			HTN			1						1	Cerebrovascular disorder; Convulsion; Encephalitis; Irritability; Lethargy; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0197914	02/19/2003	CA	79.0	79		M	02/14/2003	Encephalitis. Lethargy, alt. conscious, personality, extreme irritability, hallucinations, stiff neck, ataxia, somnolence, focal neuro, URI, CV, rash.  A 60-day follow up report received 6/10/2003 adds no new info. Annual follow up on 03/17/04: It is unknown if the pt recovered from the adverse events.			Y		Y				U	10/11/2002	11/01/2002	21		UNK	UNK	ARB, lamoxin, ASA. Lasix, antibiotic (Cipro), antihistamine, oral ant viral.		CAD, CABG, s/p dual chamber procine aortic valve, s/p dual chamber, HTN, neuropathy			1						1	Coordination abnormal; Encephalitis; Hallucination; Irritability; Lethargy; Musculoskeletal stiffness; Rash; Upper respiratory tract infection	FLU3~EVANS VACCINES~33702HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0197917	02/19/2003	CA	73.0			F	02/14/2003	Encephalitis									U		12/01/2002			UNK	UNK	Vits, Prozac, Norvasc, Amapro, Synthroid, Diplophenic		Arthritis, HTN, GERD, Hyperlipidemia			1						1	Asthma; Confusional state; Encephalitis; Meningitis; Thinking abnormal; Urinary retention	FLU3~SANOFI PASTEUR~U0949AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192441	02/20/2003	WA	61.0	61		F	11/27/2002	24 hrs later had less respiratory function than previously - lasted 2 wks. No rash. Did not report event to her PMD. Received allergy injection on 10/7/02. Saw an MD at a clinic for allergic reaction. Did not report difficulty breathing to that MD. Has subsequently seen three other MD's. Has not reported event.									Y	10/08/2002	10/09/2002	1	None	PUB	PUB	Sereventiahales nathecort nasal spray, Robeca HS, Allegra, Vioxx, HRT/Premasin, Oxybutonin, Aygista	NONE	Allergies - trees, cat, grass, molds; asthma, hypertension, reflux, arthritis.	Lemponame~Influenza (Seasonal) (no brand name)~~0.00~In Patient	WA021884	1						2	Dyspnoea; Hypersensitivity; Respiratory disorder	FLU3~SANOFI PASTEUR~U0857AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0197963	02/20/2003		26.0	26		M	12/11/2002	Over three days developed moderate Rx of redness, warm, induration approx 8x12cm area.									Y	12/07/2002	12/09/2002	2		MIL	MIL	NONE	NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site warmth	ANTH~EMERGENT BIOSOLUTIONS~FAV069~1~SC~LA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0197966	02/20/2003	WA	55.0	55		F	12/30/2002	Onset asthma symptoms without usual stimuli-(dust/cats). Persistent x 4 days at time of report. Not controlled with prn inhaler. Using nebulizer with some relief. Still symptomatic. Sx persisted through 1/1/03.									Y	12/26/2002	12/27/2002	1	NONE	UNK	UNK			Asthma well controlled with prn albuteral inhaler		WA021900	1						1	Condition aggravated	FLU3~PFIZER\WYETH~4020037~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0197967	02/20/2003	WA	46.0	45		M	12/22/2002	Pt reports last night noticing redness, swelling to L upper arm today 12/22/02 L deltoid is very swollen, red and warm 4x4 area of swelling and redness present-administered Benadryl 50mg po apply heat and f/u this week.				Y					U	12/20/2002	12/21/2002	1		PUB	PVT	PPD	NONE	Encephalitis, HTN		WA021899	1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~EVANS VACCINES~E30422GA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~SANOFI PASTEUR~U0816AA~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0197968	02/20/2003	WA	72.0	72		F	12/23/2002	12/12/02 three vaccines administered. Pneumococcal subq. 12/14/02, red, hot, swollen, infected in subq area seen in Er. Given 10 days Keflex and better in 24 hours. Seen her PMD this week.				Y					Y	12/12/2002	12/14/2002	2		PUB	PUB					WA021897	1						1	Injection site erythema; Injection site infection; Injection site oedema; Injection site warmth	FLU3~PFIZER\WYETH~4020037~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0541M~2~SC~~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U0463AA~UNK~IM~~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0197969	02/20/2003	WA		75		M	11/29/2002	Pt was given influenza vaccine and Pneumovax on 11/20/02. Pt c/o dizziness, 2 days later did not contact this office until 11/29/02 sx resolved. Decreased energy level until 11/25/02 when felt fully recovered.									Y	11/20/2002	11/22/2002	2	NONE	PVT	PUB	HCTZ 25mg qd	NONE	HTN`		WA021894	1						1	Asthenia; Dizziness	FLU3~SANOFI PASTEUR~U0913AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0675M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0197970	02/20/2003	WA	32.0	32		F	11/15/2002	Anaphylaxis with widespread urticarial rash, difficulty breathing, agitation, itching all over body. Given Epinephrine 0.3mg SC Claritin 10mg po. Solumedrol 80mg IV, HCT ringer's 1 liter IV, Ibuprofen 800mg po.				Y					Y	11/14/2002	11/14/2002	0	NONE	PVT	UNK	Ranitidine, Allegra	NONE	Asthma		WA021892	1						1	Agitation; Dyspnoea; Pruritus; Urticaria	FLU3~PFIZER\WYETH~420019~3~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0197971	02/20/2003	WA	5.0	4		F	11/15/2002	1 and 2 days after DTaP vax, left upper arm red, swollen, painful, and itchy.									Y	11/13/2002	11/14/2002	1	NONE	PVT	PUB	NONE	Recent cold	Asthma, ear infections.		WA021891	1						1	Oedema; Pain; Pruritus; Vasodilation procedure	DTAP~SANOFI PASTEUR~U0549AA~5~~LA~DTAP (TRIPEDIA)~1|FLU3~PFIZER\WYETH~4020019~1~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|IPV~SANOFI PASTEUR~U1233~4~~LA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0197972	02/20/2003	WA	13.0	13		F	11/19/2002	Swelling redness very painful down to elbow									Y	11/12/2002	11/12/2002	0		PUB	PVT	NONE	NONE	Asthma, allergy to dust		WA021890	1						1	Oedema; Pain; Vasodilation procedure	FLU3~PFIZER\WYETH~4020025~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0709M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0197973	02/20/2003	WA	9.0	9		M	11/19/2002	Down to elbow redness & streaks painful & swollen.									Y	11/12/2002	11/12/2002	0		PUB	PVT	NONE	NONE	Asthma		WA021888	1						1	Oedema; Pain; Vasodilation procedure	FLU3~PFIZER\WYETH~4020025~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0709M~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0197974	02/20/2003	WA	8.0	7		M	11/19/2002	Left arm upper swelling redness & pain down to wrist. Extremely painful x 4-5 days. Slight wheezing whole arm swollen, vomiting x2 days.									Y	11/12/2002	11/12/2002	0		PUB	PVT		NONE	Allergic to corn rice and molds, asthma		WA021889	1						1	Asthma; Oedema; Pain; Vasodilation procedure; Vomiting	FLU3~PFIZER\WYETH~4020025~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0709M~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0197975	02/20/2003	NY	68.0	68		F	02/12/2003	Received Influenza vaccine on 11/15/02. W/in 2 days developed sore arm. Left from shoulder to elbow - continued to have pain / soreness 3 months later.									N	11/15/2002	11/17/2002	2		PUB	PUB		N/A	N/A			1						1	Myalgia; Pain	FLU3~EVANS VACCINES~31192HA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0197976	02/20/2003	WA	54.0	54		F	02/05/2003	Have had upper and lower gastrointestinal distress, nausea, persistent diarrhea since Nov. 2002. All Dx studies WNL. Neg. upper GI, Abd. Ct., EGD, Colonoscopy, Blood work normal diarrhea loose stools continue daily.										11/05/2002	11/18/2002	13		PUB	UNK	Femhrt	NONE			WA021886	1						1	Diarrhoea; Gastrointestinal disorder; Nausea	FLU3~SANOFI PASTEUR~U0951AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0197978	02/20/2003	MI	21.0	21		M	02/13/2003	Pt felt diaphoretic, pale and nauseated 10 mins after receiving the shot.									Y	11/05/2002	11/05/2002	0	NONE	OTH	PVT	NONE					1						1	Hyperhidrosis; Nausea; Pallor	FLU3~SANOFI PASTEUR~U0910AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0197979	02/20/2003	MI	38.0	38		F	02/06/2003	11/14/02 - Left arm painful to lift after receiving shot, spoke w/PT on 2/6/03. Arm is fine - took a couple of wks to get better - case closed.									Y	11/14/2002	11/14/2002	0	NONE	OTH	PVT		NONE	N/A			1						1	Pain	FLU3~SANOFI PASTEUR~U0937AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0197980	02/20/2003	IL	33.0	33		M	10/28/2002	PT experienced mild case of Guillain Barr‚ syndrome.									Y	10/28/2002	11/14/2002	17	Blood work, physical exam, R/O (no spinal tab needed)/ MRI x2	OTH	OTH	NONE	NONE	NONE			1						1	Guillain-Barre syndrome	FLU3~SANOFI PASTEUR~U0872AB~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0198225	02/25/2003	CA	56.0	56		F	01/23/2003	Fever and cough 24 hrs post flu vaccine. Took Sudafed and had headaches and numbness of legs and hands. Also had chest, abdominal pain and thoracic back pain. Started to have right facial numbness on 11/22/02 which progressed to the whole face. (See note on neurological consult/possible Guillain Barre). I was called by MD to see this pt for emergency neurology consultation of bilateral hand, state numbness, nausea and vomiting and facial weakness. The pt developed some fever and coughing within 24 hrs after the flu shot injection. She presented to the ER on 11/22/02. ER workup including head CT, chest x-ray, thoracic spine x-ray which was unremarkable except chest CT showed minor bilateral atelectasis/infiltrate.  The pt deny urine and bowel incontinence but do complain of some shortness of breath.				Y	Y				Y	11/07/2002	11/08/2002	1	Possible GBS following flu shot. ER workup including head CT, chest x-ray, thoracic spine x-ray which was unremarkable except chest CT showed minor bilateral atelectasis/infiltrate.	OTH	PUB	Insulin; Glyburide; Usinopril	NONE	Diabetes		CA020114	1						1	Abdominal pain; Back pain; Chest pain; Cough; Dyspnoea; Facial palsy; Guillain-Barre syndrome; Headache; Hypoaesthesia; Laboratory test abnormal; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U0953AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0198226	02/25/2003	SC	68.0	68		F	02/14/2003	Administered at 12/31/02. Patient developed right upper lung lobe pneumonia with sinus tachycardia and right upper extremity tremors. Patient hospitalized. The discharge summary states hyperkalemia and elevated platelets.				Y	Y	13	Y		Y	12/31/2002			MRI, Brain, CXR, EKG, Chest CT, Labs	PVT	OTH	Cozaar; Synthroid, Evista; Zocor; Prilosec; ASA	NONE	Hyperlipidemia; HTN; Hypothyroidism; Chest pains; NKA			1						1	Hyperkalaemia; Pneumonia; Sinus tachycardia; Thrombocythaemia; Tremor	FLU3~SANOFI PASTEUR~U0949AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0198227	02/25/2003	UT	55.0	55		M	02/12/2003	Symptoms similar to meningitis; severe headache, stiff neck, aching. No evidence.				Y	Y	2			Y	11/22/2002	11/30/2002	8	CT Scan; Lumbar puncture; MRI	OTH	PVT	NONE	Achy	History of polio as a child			1						1	Headache; Infection; Laboratory test abnormal; Lactic acidosis; Musculoskeletal stiffness; Myalgia; Pain; Viral infection	FLU3~PFIZER\WYETH~4020036~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0198236	02/25/2003	MI	40.0	40		F	02/19/2003	Nov - chest cold, achy, fever, extremely tired, felt like someone hit her in back. Dr treated for respiratory infection. Took Rx and felt good off and on until Jan 03; saw Dr in Jan because teeth hurt so much - treated for infection with Zithromax. Took meds and continued mouth pain with low grade fever; saw Dr Feb 12.									U	10/04/2002	10/08/2002	4	Chest x-ray 2/19/2003 Epstein Barr Virus	PUB	UNK		NONE	NONE			1						1	Fatigue; Pain; Pyrexia; Respiratory tract infection; Tooth disorder	FLU3~PFIZER\WYETH~4020022~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0198237	02/25/2003	SC	59.0	59		F	01/06/2003	PT received flu and Td vaccines on 11/6/02. Had pain x 6 days. Return to HD on 11/12/02. Swelling and bruising noted on left arm (had Td in left arm, flu in right arm) and pain. To MD on 1/6/03, light swelling and bruising gone but still having pain. To be treated with anti inflammatory x 2 wks and return to PMD in 2 wks.				Y						11/06/2002	11/12/2002	6		PUB	PUB		NONE	NONE		SC0270	1						1	Contusion; Oedema; Pain	FLU3~SANOFI PASTEUR~U0935AA~4~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0820AA~1~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0198238	02/25/2003	SC	62.0	62		F	02/11/2003	10/14/2002 recv'd Td and Flu Vaccine in left deltoid. two days latter arm sore from shoulder to elbow and was swollen and hot from shoulder to elbow. Saw private MD 1/27/2003 and advised her to use hot compresses and to see MD again 4/28/2003.									Y	10/14/2002	10/16/2002	2		PUB	UNK	diazoxide; Norvase	diabetic; hypertension	diabetic; hypertension		SC0271	1						1	Injection site pain; Injection site swelling; Pyrexia	FLU3~SANOFI PASTEUR~U0926AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0524AA~UNK~IM~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0198239	02/25/2003	SD	0.9	0	.8	F	12/27/2002	Symptoms started the night she got the shot. Had sleepless nights and was very fussy for one week. No cough, no fever, no site redness. Mom refused to given child the second shot. Mom states child got better for a couple of days and then got sick again with cold symptoms. Has not taken child to MD. Did have a call into him today to have him call her back about symptoms.									Y	11/08/2002	11/08/2002	0		PUB	PUB	NONE	NONE	NONE		SD02022	1						1	Insomnia; Irritability; Pharyngitis; Rhinitis	FLU3~PFIZER\WYETH~4020033~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0198240	02/25/2003	SD	51.0	51		M	11/13/2002	Ill-scratchy throat, stuffy head, tired, cough settled in chest. Green phlegm and called MD. Zithromax ordered and completed. 12/17/02 states twk 2nd antibiotic and new bronchitis subsiding. Some SOB and cough yet hx of bronchitis.				Y					Y	10/30/2002	11/01/2002	2		PUB	PUB	Avondia; Glucovaye; Accupril; Tiazac; Lipitor; Vioxx		Bronchitis		SD02021	1						1	Bronchitis; Cough; Dyspnoea; Head discomfort; Throat tightness	FLU3~PFIZER\WYETH~4020023~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0198241	02/25/2003	TN	49.0	49		F	11/21/2002	Received pneumonia vaccine R deltoid. Few cm below injection site-red raised hot to touch 25 cent size now but approximately 50 cents on Mon 11/18. Area sore has gradually ? H/A all over head, photophobia, occ. blurred vision, heart racing 1 1/2 hr felt weird.									Y	11/18/2002	11/18/2002	0	BP 110/70; HR 842; RR 20, T 976	PUB	PUB	Allergy shots, ASA chol, Zyrtec, 3 inhalers, Premarin		PCN/sulfa/EES/Lorcet and adhesive tape allergies		TN03004	1						1	Feeling abnormal; Headache; Heart rate increased; Injection site erythema; Injection site swelling; Injection site warmth; Photophobia; Vision blurred	FLU3~PFIZER\WYETH~4020033~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1352L~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0198242	02/25/2003	TN	60.0	60		F	11/20/2002	Flu shot L/ pneumonia R-became red and swollen, tender to touch, hot to touch. had gotten pneumonia maybe two year ago. No SOB. Tx with Medrol dose pack/Cephalexin 500 bid. Pt called 11/20/02 re: adverse reaction. Add: when pt asked Re: notifying clinic re: adverse reaction. She stated I thought it would pass.									Y	11/18/2002	11/18/2002	0	NONE	PUB	PUB	Atenolol	NONE	All. sulfa, mitral valve replacement		TN03005	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~PFIZER\WYETH~4020002~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1352L~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0198243	02/25/2003	TN	42.0	42		F	11/20/2002	Received flu shot L deltoid (bandaid applied) became red and warm to touch, itchy and stung, later that day (4x3 area) used ice and hydrocortisone cream to area and Benadryl one cups-full recovery next day reported some malaise next day.									Y	11/18/2002	11/18/2002	0	nONE	PUB	PUB	WEllbutrim, Celexa, Nexeum, Skelaxin, Levabid	NONE	Food allergies, morphine, Demerol, Betadine, tape		TN03006	1						1	Injection site erythema; Injection site hypersensitivity; Injection site pain; Injection site warmth; Malaise; Pruritus	FLU3~PFIZER\WYETH~4020033~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0198245	02/25/2003	TN	44.0	47		F	01/07/2003	Pt reports a pimple over injection site one week after shot - went away one month later. Pain at injection site one day post shot. Never relieved - now pain with movement of shoulder in all directions, numbness in lt arm, pain awakened pt at night.									N	11/18/2002	11/28/2002	10		PUB	OTH					TN03007	1						1	Arthralgia; Hypoaesthesia; Injection site pain; Injection site swelling	FLU3~PFIZER\WYETH~4020033~UNK~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0198246	02/25/2003	IA	51.0	51		M	01/10/2003	Initially noted soreness in R arm within 48-72 hrs. On around 11/5 noticed a red crusty area on R arm and then on chest/stomach area. To this date 1/10/03 noted 12 round lesions on both arms and chest/abdominal area.									Y	11/02/2002				MIL	MIL	PPD	NONE	NONE			1						1	Injection site pain; Skin ulcer	FLU3~SANOFI PASTEUR~U0983AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0600L~3~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TD~SANOFI PASTEUR~U0524A~4~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0198247	02/25/2003	IA	44.0	44		F	02/06/2003	Approximately three weeks after immunizations had dizziness, itchiness, flu like symptoms 2/6/03 mild urticaria noted in both upper arms abdomen and both inner thigh area.									Y	12/07/2002	12/31/2002	24		MIL	MIL	PPD	NONE	year around-mold dust			1						1	Dizziness; Influenza like illness; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0983AA~6~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0600l~3~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1|TD~SANOFI PASTEUR~U0524AA~4~IM~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0198298	02/25/2003	MD	32.0	32		F	02/24/2003	Pt woke up the following morning with a swollen lt arm and lt side of face. She also developed diarrhea, but symptoms resolved within 24-48 hrs.				Y					Y	02/14/2003	02/15/2003	1		PVT	UNK	could not read; Glucophage, aspirin	NONE	Diabetes; Obesity			1						1	Diarrhoea; Swelling	FLUX~UNKNOWN MANUFACTURER~04036aa~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0198299	02/25/2003		71.0			F		A report was received from a regulatory authority on 2/17/03 concerning a 71 y.o. female vaccinee who developed chronic diarrhea which was considered disabling for an unspecified length of time after receiving Fluvirin on 10/12/02. Concomitant medications taken included thyroxine and hydroxocobalamin. The vaccinee has a history of hypothyroidism and Addisonian pernicious anaemia. On an unreported date the vaccinee developed chronic and frequent diarrhea. Stool culture was negative. No cause was found. The vaccinee had not recovered at the time of the event. There was insufficient info to determine the reporter's causality assessment.								Y		10/12/2002			Stool culture, date unknown, result negative	UNK	UNK	Hydroxocobalamine, thyroxine		Hypothyroidism, Addisonian pernicious anaemia.		PJP2003000670	1						1	Diarrhoea	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0198357	02/26/2003	MI	64.0	64		M	02/19/2003	Complained of sore and stiff lung and pressure on left side lung; hx of emphysema from smoking 2 packs a day. Called on 11/25/02; doing fine. Case closed. The discharge summary states COPD, and alcohol withdrawal.					Y				Y	10/28/2002	10/28/2002	0		OTH	PVT		NONE	Coronary artery disease, hypertension, hypercholesteremia, DM II, tobacco abuse, alcohol abuse			1						1	Chest discomfort; Delirium; Lung disorder	FLU3~SANOFI PASTEUR~U0937AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0111M~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0198359	02/26/2003	MI	73.0	72		F	02/19/2003	Had achy muscles, cough and dizziness. Went to hospital; had pneumonia. Hospitalized 11/18 for 7 days. Discharge summary states short of breath, fever. msv					Y	7			Y	10/20/2002	10/21/2002	1	Discharge summary states abnormal lab test, H&H decreased. msv	OTH	UNK	Antibiotics in hospital		Discharge summary states allergy. msv			1						1	Anaemia; Cough; Dizziness; Dyspnoea; Laboratory test abnormal; Myalgia; Pneumonia; Pyrexia	FLU3~SANOFI PASTEUR~U0910AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0198360	02/26/2003	MA	68.0	67		F	02/20/2003	Received vaccine 10/21/2002 and Dec 7 2002. Flu symptoms, aches, pains, swollen joints. On 12/08/2002 into 12/09/2002 awoke with generalized body pain admitted 12/09 -012/10 rheumotoid symptoms. W/U awful. Increase sedrate. Dx'd acute arthrytic inflammation. The 60 day report states she recovered from the acute event fro which she was hospitalized. She still had arthritic complaints. She continues with follow up care and does continue to (unknown) to work.  She was hospitalized in summer 03 in the midwest with fevers of unknown origin. I really don't believe that this has anything to do with vaccine but pt questioned it. Nurse follow up on 05/18/04 states: Malaise, aches, back pain, stiffness,				Y	Y	1			Y	10/21/2002	12/07/2002	47	Sedrate elevated at 79.  Nurse follow up on 05/18/04 states: Lab values abnormal, sed rate elevated.	PVT	PVT	Fosomax, Vitamins	NONE	Hx of diverticulitis, hx of osteoporosis			1						1	Arthritis; Back pain; Hypertonia; Laboratory test abnormal; Malaise; Pain; Pyrexia; Red blood cell sedimentation rate increased	FLU3~SANOFI PASTEUR~U0904CA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0198361	02/26/2003	FL	43.0	43		F	02/13/2003	Lump in left axillary. Sensitivity to cold. Pain radiating in left arm. Chronic pain in left breast and under left arm.  Per 60 day follw up: pain neurological symptoms including burning, tingling, sensations throughout body. Still have lump from flushot and presently under dis care for possible auto-immune damage and neurological damage. Thank you for your help and consideration : )					Y	1			N	10/09/2002	10/30/2002	21	Surgical biopsy 12/10/02 in left axillary	PVT	UNK		NONE	Hay fever only			1						1	Breast pain; Immune system disorder; Injection site mass; Nervous system disorder; Pain; Paraesthesia; Skin burning sensation	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0198363	02/26/2003	MI	31.0	31		M	02/19/2003	PT stated throat a little tight, and had a little headache. Reports improved throat in AM. Denies breathing difficulties, rash or fever at this time. Annual follow up on 04/14/04: It is unknown if pt recovered from adverse events.					Y	2			U	11/04/2002	11/04/2002	0	Cat scan of head - neg.	PUB	PVT						1						1	Headache; Laryngospasm	FLU3~SANOFI PASTEUR~U0937AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0198371	02/26/2003	MI	72.0	72		F	02/19/2003	Right arm tender and red, aching after receiving pneumonia shot. She called her MD, took Benadryl and Motrin, put ice pack on it - 11/1/02 called PT - redness resolved feeling fine. Case closed.									Y	10/29/2002	10/29/2002	0		OTH	PVT		NONE				1						1	Pain; Vasodilation procedure	FLU3~SANOFI PASTEUR~U0910AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0995L~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0198372	02/26/2003	MI	46.0	46		F	02/13/2003	Had welt on flu shot site with small blisters. Blister and welts cleared up. Doing fine. Case closed. 11/25/2003									Y	11/03/2002	11/03/2002	0		OTH	PVT		NONE				1						1	Blister; Urticaria	FLU3~SANOFI PASTEUR~U0937AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0198373	02/26/2003	MI	61.0	61		F	02/19/2003	Had swelling after pneumonia shot. Size of ? and felt faint, applied ice. Swelling resolved. Case closed.									Y	11/02/2002	11/02/2002	0		OTH	PVT						1						1	Injection site oedema; Syncope	FLU3~SANOFI PASTEUR~U0937AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0111M~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0198374	02/26/2003	MI	33.0	33		F	02/19/2003	Had some nausea and vomiting x 1. Arm a little sore. Left arm size of quarter. Tenderness. 10/31/2002 Feeling better. Case closed.									Y	10/30/2002	10/30/2002	0		OTH	PVT						1						1	Injection site pain; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U0910AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0198375	02/26/2003	MI	38.0	39		F	02/19/2003	1/2 hour after receiving pneumonia shot, right arm swollen, hot, and hurt. Couldn't lift over head. Went to M.D. On antibiotics and had Cortisone shot 11/22/2002. Stated arm doing alot better. Case closed.				Y					Y	11/19/2002	11/19/2002	0		OTH	PVT						1						1	Injection site oedema; Injection site pain; Injection site warmth; Joint range of motion decreased	FLU3~SANOFI PASTEUR~U0937AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0111M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0198379	02/26/2003	MI	79.0	79		F	02/19/2003	Felt warm and cold and had runny nose and headache, took Tylenol 11/11/02 client fine. Case closed.									Y	10/30/2002	10/30/2002	0		OTH	PVT						1						1	Feeling cold; Feeling hot; Headache; Rhinorrhoea	FLU3~SANOFI PASTEUR~U0937AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0198380	02/26/2003	MI	72.0	72		F	02/14/2003	Felt dizzy the evening of receiving flu shot. Took a day and a half for dizziness to go away. Doing fine. Case closed. 11/13/2002									Y	11/06/2002	11/06/2002	0		OTH	PVT		NONE				1						1	Dizziness	FLU3~SANOFI PASTEUR~U0910AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0198381	02/26/2003	MI	33.0	33		F	02/19/2003	After receiving IM shot for flu c/o pain going up left side. Tenderness at site. Spoke with pt on 2/5/03 arm fine, no adverse relations. Case closed.									Y	11/11/2002	11/11/2002	0		OTH	PVT						1						1	Injection site pain; Pain	FLU3~SANOFI PASTEUR~U0910AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0198382	02/26/2003	MI	76.0	76		F	02/19/2003	Had bad diarrhea 2-3 days. Went to Dr, gave her pills - stools back to normal 10/23/2002.  Case closed.				Y					Y	10/18/2002	10/19/2002	1	Went to Doctor's	OTH	PVT		NONE				1						1	Diarrhoea	FLU3~SANOFI PASTEUR~U0910AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0198384	02/26/2003	MI	58.0	58		F	02/19/2003	Lt arm hot, red and swollen after flu shot. Took Motrin, applied moist compress - arm is fine on 10/31/2002									Y	10/18/2002	10/18/2002	0		OTH	PVT		NONE				1						1	Feeling hot; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U0910AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0198390	02/26/2003	OK	63.0	63		F	02/17/2003										Y	01/22/2003	01/22/2003	0		PVT	PVT	Captopril, Lasix; Singulair; Theophyline, Albuterol, Atrovent, Indocet, Metaprolol	Costochondritis	HTN, Asthma			1						1	Unevaluable event	FLU3~PFIZER\WYETH~4020018~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0955~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0198433	02/26/2003	VA	30.0	29		F	02/11/2003	Pt vaccinated with smallpox vaccine 1/29/03.  (Pt is vaccinee) developed macular-papular rash 5 days ago 2/5/03. Also immunized with several vaccine on same day. The progress note per description of rash. Rx Allegra 180mg and Moisturizer cream with stroid. Rash fading. Received Anthrax #3 2/3/03.									Y	01/29/2003	02/05/2003	7	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Rash maculo-papular	FLU3~SANOFI PASTEUR~U1957AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1018M~UNK~~~HEP B (FOREIGN)~1|HEPA~MERCK & CO. INC.~0827M~UNK~~~HEP A (VAQTA)~1|SMALL~PFIZER\WYETH~4020071~1~SC~LA~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~U1073~UNK~~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0198434	02/26/2003	GA	24.0	24		F	02/19/2003	Approximately 1 min post vaccination pt reported tingly all over for started to swell, chest became tight and throat swelling EMS contacted given Epi 0.3 and 25mg, Benadryl IM and throat swelling on around minimal wheezing Solu/Tosant/Benadryl monitoring x 4 no insult.				Y					Y	02/18/2003	02/18/2003	0	NONE	UNK	UNK	PPD					1						1	Chest discomfort; Oedema; Paraesthesia; Pharyngeal oedema; Wheezing	ANTH~EMERGENT BIOSOLUTIONS~~UNK~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1|YF~SANOFI PASTEUR~~UNK~~~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0198440	02/27/2003	IL	9.0	8		M	02/18/2003	Pt's family reports was diagnosed with chickepox 12/2002. Normal cause of disease.				Y					Y	12/20/2001				PUB	PUB		NONE	Asthma, estaopia/strabismus			1						1	Infection	FLU3~EVANS VACCINES~609871WA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARCEL~MERCK & CO. INC.~9311506~1~~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0198551	02/27/2003	PA	19.0	19		M	02/27/2003	On 2/22/03, pt c/o syncope,dizziness,lightheadedness,headache,neck pain,fever,generalized weakness, and urinary retention.  Now with weaknes and numbness in legs. Diagnosed: acute disseminated encephalomyelitis likely secondary to anthrax vaccine.  Treated with steroids and physical therapy. Awaiting transfer to Hospital . The 60 day follow up states pt was transferred to hospital.  Annual follow up on 03/24/04: It is unknown if the pt recovered from adverse events.  Please contact the US Army.					Y	5			U	02/20/2003	02/22/2003	2	MRI 2/24:white matter changes in R posterior,bilateral parietal and occipital regions.  Ischemia,gliosis, or demyelination. 2/22 CSF: WBC=159, Protein:73; CSF: good IgM response by MAC-ELISA (OD ratio 9.8)(negative to West Nile, St. Louis, and Powassan), neutralization antibody assay not done for CSF, negative virus culture on Vero cells, TaqMan PCR for yellow fever was not done; Serum: good IgM response by MAC-ELISA (OD ratio 9.8)(negative to West Nile, St. Louis, and Powassan), plaque-reduction neutralization test to yellow fever virus was positive at a 1:320 titer, negative virus culture on Vero cells, negative TaqMan PCR for yellow fever.	MIL	MIL	Placed on amoxicillin 2/21/03	Sore throat	No allergies			1						1	Asthenia; Dizziness; Encephalitis; Headache; Hypoaesthesia; Laboratory test abnormal; Neck pain; Pyrexia; Syncope; Urinary retention; Difficulty in walking; Encephalitis; Headache; Hypoaesthesia; Infection parasitic; Laboratory test abnormal; Micturition urgency; Pharyngolaryngeal pain; Pyrexia; Sensory disturbance; Urinary retention; Asthenia; Depressed level of consciousness; Difficulty in walking; Encephalitis; Headache; Hypoaesthesia; Laboratory test abnormal; Pharyngolaryngeal pain; Pyrexia; Urinary retention	ANTH~EMERGENT BIOSOLUTIONS~~2~IM~~ANTHRAX (BIOTHRAX)~1|ANTH~EMERGENT BIOSOLUTIONS~~1~~~ANTHRAX (BIOTHRAX)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEP~UNKNOWN MANUFACTURER~~2~~~HEP B (NO BRAND NAME)~2|HEPA~UNKNOWN MANUFACTURER~~1~~~HEP A (NO BRAND NAME)~2|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~2|MMR~UNKNOWN MANUFACTURER~~2~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~2|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~2|YF~UNKNOWN MANUFACTURER~~UNK~~~YELLOW FEVER (NO BRAND NAME)~2|ANTH~EMERGENT BIOSOLUTIONS~~1~~~ANTHRAX (BIOTHRAX)~3|HEP~MERCK & CO. INC.~~2~~~HEP B (RECOMBIVAX HB)~3|HEPA~MERCK & CO. INC.~~1~~~HEP A (VAQTA)~3|MMR~MERCK & CO. INC.~~2~~~MEASLES + MUMPS + RUBELLA (MMR II)~3|VARCEL~MERCK & CO. INC.~~UNK~~~VARICELLA (VARIVAX)~3|YF~UNKNOWN MANUFACTURER~~UNK~~~YELLOW FEVER (NO BRAND NAME)~3	USA	Hospitalisation	Influenza
0198477	02/28/2003		49.0	49		M	02/26/2003	It was reported that a pt was vaccinated with an influenza vaccine in November 2002 by the army. Three weeks later he experienced cerebellitis and was hospitalized. As a cause wasn't found, the treating physician felt a possible relationship with the influenza vaccination. He is treated with methylprednisone IV and slowly improving. At the time of this report he is not recovered yet. We asked for the hospital report. Further info is expected.  A 15-day follow up report received 04/17/2003 adds: The pt was hospitalized from 12/09/2002 till 12/17/2002 for further investigations. First symptoms as feeling unsteadiness while walking and clumsiness of speech occurred on 12/05/2002. These symptoms progressed during the following days and necessitated a neurologic consultation. The cranial MRI showed no abnormalities. Physical examination showed a gaze-evoked nystagmus to the left, marked cerebellar dysarthria, dysdiadochokinesis on the right, on the left, moderate broad-based gait ataxia, slightly dysmetric finger-to-nose test and heel-to-shin test, slight action tremor, markedly hypermetric finger-finger-test. No tremor at rest, no myoclonus. No sensory abnormalities. No vegetative dysfunction. Exam of heart, vessels, lymphnodes, lung, abdomen, thyroid, skin unremarkable. The pt was treated with corticosteroid (500 mg methyprednisolone/day IV from 12/12 till 12/14/2002. After this treatment there seemed to be a slight improvement of dysarthria and gait ataxia. The diagnosis of cerebillitis due to a viral disease or immunization or a paraneoplastic mechanism was discussed to be the cause of the cerebellar syndrome, but none could be verified. At the time of this report the symptoms improved slowly but the pt was not yet recovered. No further info is expected. File closed.					Y			Y	N	11/01/2002	12/01/2002	30		MIL	MIL					U200300076	1						1	Cerebellar syndrome; Coordination abnormal	FLU3~SANOFI PASTEUR~U0984AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0198480	02/28/2003	RI	82.0	82		M	02/25/2003	Pt received influenza vaccine 10/19/02 and since that evening pt felt tired, weak, had difficulty walking due to weakness and fever of 100-101 degrees; decreased appetite, lethargy.					Y	3			Y	10/19/2002	10/19/2002	0	NONE	OTH	OTH	Enaldpril 10mg tid, Atenolol 50mg bid, HCTZ 25mg qd, Lenoxin .25mg qd	NONE	Hypertension, bell's palsy, hx s/p colon adenocarcinoma, cardiovascular disease. Documented allergies: Aspirin, caffine, prednisone.			1						1	Asthenia; Decreased appetite; Difficulty in walking; Fatigue; Lethargy; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0198484	02/28/2003	MD	50.0			M	02/24/2003	PT states: I received a flu vax in my left arm. I noticed some tenderness in the area of my left deltoid 2 days [post vax] that was especially pronounced when I did push-ups, pull-ups or swimming. This tendonitis is still present after several months, although milder. Otherwise my health is excellent. Is it possible that local inflammation from the fax predisposes people to tendonitis? Or is the timing and location of the tendonitis coincidental?											10/25/2002		NONE	UNK	UNK	Tendonitis		NONE			1						1	Tenderness; Tendonitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0198576	02/28/2003	GA	20.0	20		M	02/20/2003	Patient presented to emergency room with chief complaint of chest pain. MI ruled out diagnosis of myocarditis associated with smallpox vaccination 2/5/03. Patient was initially admitted to cardiac ICU, but then discharged to home in stable condition on 2/16/03. Echo normal. Patient will be followed up in 2 weeks by doctor.			Y	Y	Y	3			Y	02/05/2003	02/13/2003	8	Echocardiogram, Cardiac enzymes, EKG's	MIL	MIL	Motrin	NONE	NONE			1						1	Chest pain; Myocarditis; Headache; Myocarditis; Laboratory test abnormal; Nonspecific reaction	FLU3~SANOFI PASTEUR~U0957AA~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020071~1~~~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~U1203~2~IM~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|ANTH~EMERGENT BIOSOLUTIONS~~2~~~ANTHRAX (BIOTHRAX)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|SMALL~PFIZER\WYETH~~1~~~SMALLPOX (DRYVAX)~2|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~2|SMALL~PFIZER\WYETH~~1~~~SMALLPOX (DRYVAX)~3	USA	Life Threatening,Hospitalisation	Influenza
0197474	03/03/2003	SD	44.0	44		M	02/17/2003	2 days after the flu shot, my vision in my right eye starting getting blurry. After various tests (MRI) (spinal tap) the doctors decided I have optic neuritis. My vision is still blurry.								Y	U	11/01/2002	11/02/2002	1	MRI; Spinal tap checked for MS; Eye exams; Blood work	OTH	PVT	Apirin; Proscar; Vitamins	NONE	NONE			1						2	Optic neuritis; Vision blurred; Visual disturbance; Optic neuritis; Vision blurred	FLUX~UNKNOWN MANUFACTURER~~5~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U0910AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Disabling	Influenza
0198599	03/03/2003			29		M	02/19/2003	1) Headaches - > 3 yrs. These have become daily occurrences that are of insidious onset, any time/location and can last several hrs. These headaches are occipital, 4/10, radiating slightly to neck, no provocative measures, palliated w/OTC Excedrin. No aura, no N/V, no photo/+phonophobia, no N/T/W. No previous H/A hx. 2) Dizziness - @ 4 yrs. These Sx are intermittent from once a month to twice per week. They can last seconds to 1.5 days. PT feels room spinning, disoriented, can't focus, +N/-V, no syncopal episodes. Sx Tx'd with Meclizine. 3) Heart Murmur - PT was told he had palpitations. A holter monitor was performed, which was apparently benign and PT was given reassurance. These Sx occur at once/month, last secs to mins. No CP, SOB, lightheaded, diaphoretic. 4) Fatigue x @ 3 yrs. This Sx has been increasing. They are intermittent, least weekly occurring any time throughout the day. PT sleeps well. He does admit to snoring, but not bad enough to wake himself. +cold intolerance which occurs when not wearing ear protection. 10 lbs wt gain last 1.5 yrs no constipation. Diet average, +exercise. 5) SOB - X ___. PT feels when going to sleep, either upright or lying feels winded and has to take 7-8 breaths to get back to normal breathing. No Sx w/exercise. No LE edema. No tobacco, no asthma, hx. Rash R>L eyelids X 1.5 yrs. Rash occurs just below eyelid. +pruritic. Uncertain of past Tx. PT has been a German OTC cream with so-so relief. No hx eczema/atopic dermatitis. 7) Short-term memory loss. PT states he has to write everything down - i.e. apts, conversations. No problems w/long-term memory. No previous prob's. 8) Chronic sinusitis since 98. PT states he is chronically stuffy, no ocular Sx, +post-nasal drainage, no sneezing, slight cough, no F/C. No hx AR. Tx'd w/Benadryl w/out significant relief. Complete. PE to include HEENT, neck, heart, lungs, abdomen, and neurologic exam notable only for slight nasal mucosa bogginess w/scant clear rhinorrhea. Current Tx: we are monitoring headaches as they seem to be tension-type headaches and at last visit improving. Monitoring vertigo as we work on his sinuses to see if related. Monitoring palpitations given already had w/u - consider beta blocker if persists and negative SOB w/u. For fatigue check labs, CBC, Met Panel, TSH, EBV, CMV, ANA improving diet and increasing regular cardiovascular exercise. SOB likely d/t sinuses and post-nasal drainage - further w/u pending results of Tx. Dermatitis consistent w/seb derm or eczematous - we are doing a trial of hydrocortisone 1% to AA BID/PRN. Subjective short-term memory loss - monitoring w/nl PE - may need neuro eval if persist/worsen. Chronic sinusitis - currently starting Allegra, Deconsal II, and Biaxin.				Y					U	09/21/1998			Complete. PE to include HEENT, neck, heart, lungs, abdomen, and neurologic exam notable only for slight nasal mucosa bogginess with scant clear rhinorrhea.	MIL	MIL	Current tx: we are monitoring headaches as they seem to be tension-type headaches and at last visit improving. Monitoring vertigo as we work on his sinuses to see if related. Monitoring palpitations given already had w/u - consider beta blo					1						1	Amnesia; Dizziness; Dyspnoea; Fatigue; Headache; Palpitations; Rash; Rash pruritic; Sinusitis	ANTH~EMERGENT BIOSOLUTIONS~FAV017~3~SC~~ANTHRAX (BIOTHRAX)~1|FLU3~PFIZER\WYETH~4958247~5~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0198601	03/03/2003	GA	7.0	7		M	02/05/2003	04:50 p. Here for PNU and Flu requested per M.D. PNU RD and Flu Ld. ppeared pale and both arms started jerking 10 minutes after imm. given. 5:00  BP 113/67 P 104 R20  5:05p all called. 05:08  BP 107/58 P 97 R 18 Skin warm and dry. Alert still pale but a little greenish in appearance. EMT's arrived 05:10p BP 113/64 P 100 R 20. Mother agreed to have EMT transport child to ER for evaluation. Child walked out with assistance. All info. sent with pt.				Y					N	02/04/2003	02/04/2003	0		PUB	PUB			Allergies to mold mildew.		GA03009	1						1	Dyskinesia; Pallor; Skin discolouration	FLU3~PFIZER\WYETH~4020033~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0955M~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0198603	03/03/2003	MO	29.0	29		F	10/24/2002	2x2 swollen lump at vaccination site, hot to touch, very itchy, sore to touch. (Above symptoms started about 1.5-2 hours after vaccine administered). Lasted for 4 days.									Y	10/10/2002	10/10/2002	0	NONE	OTH	PVT	Prozac; Orthotricyclen	NONE	Mitral valve prolapse			1						1	Injection site hypersensitivity; Injection site mass; Injection site pain; Injection site warmth; Pruritus	FLU3~EVANS VACCINES~E31912HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0198609	03/03/2003	PA	42.0			F	11/24/2002	After receiving 3 Lyme vaccines, I started having Lyme symptoms including joint pain, vertigo and fainting.				Y					N		08/03/2000			PVT	UNK	NONE	NONE	NONE			1						1	Arthralgia; Syncope; Vertigo	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0198682	03/04/2003	NY	44.0	44		F	02/28/2003	Over the course of a week, pt developed profound sensory loss and weakness of legs and bladder. Was hospitalized for several weeks and given treatment with steroids and IVIG. Pt has slowly recovered. Can now walk but still with sensory loss pain in legs. Still recovering.   The medical record received on 3/3/04 states transverse myelitis and anxiety. Annual follow up on 03/17/04: The pt has not recovered from adverse events.  Still has numbness and tingling from toes up to hips. Feet range from completely numb to very painful.  Never have normal feeling in feet and legs.  Balance is off and cannot run. Must always watch feet, especially on stairs or uneven walkways. Still have no idea of my space in relation to feet and sometimes legs.					Y	21			N	11/19/2002	11/23/2003	369	MRI negative, lumbar puncture (+) oligoclonal band	OTH	PVT	NONE	NONE	NONE			1						1	Anxiety; Difficulty in walking; Laboratory test abnormal; Muscular weakness; Myelitis; Pain; Sensory disturbance	FLU3~EVANS VACCINES~E35822KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0198698	03/04/2003	WA	65.0	65		F	02/22/2003	Urticaria onset 11/27/02; newtropenia onset 12/8/02 (ANC 300)				Y						11/12/2002	11/27/2002	15	Bone marrow biopsy - cytogenic abnormality detection long arm chromosome 21 @ band Q 22	PVT	PVT	Prednisone, diclofenac, arara, prevacid, lotensin, adrair	NONE	Rheumatoid arthritis, allergy, - lodiniaye (?) to rash, metho aezate (?), interstitial lung disease			1						1	Neutropenia; Urticaria	FLU3~SANOFI PASTEUR~U0951AA~1~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0709M~2~SC~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0198699	03/04/2003	CA	45.0	45		F	12/04/2002	PT had a flu shot on 11/4/02. That evening, she developed hives on torso and both arms, next day both legs with intense itching. Hives and itching lasted 3 days then subsided. 12/13/02 PT used Aveno lotion - did not go to MD or take antihistamines. Now says hives occurred 48-50 hrs later on 11/6/02. Says this was flu 12 #2.									Y	11/04/2002	11/04/2002	0		PUB	UNK		NONE				1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U0919AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0198739	03/04/2003	NY	65.0	65		F	01/09/2003	Approx 30 min after injection pt experienced pain in rt upper arm.  Swollen from elbow to shoulder. Next day this area was very hard and painful. Swollen 2 weeks and pain. Even to today's visit pt still has lots of pain in injection site.				Y					Y	10/23/2002	10/23/2002	0	X-Rays; Lab work	PVT	OTH	Premarin; doxepin 150mg; Xanax 1mg; Didronel 400mg	NONE	anxiety/depression; chronic neck pain; rt shoulder adhesions			1						1	Injection site induration; Injection site pain; Swelling; Injection site erythema; Injection site induration; Injection site oedema	PPV~MERCK & CO. INC.~O111M~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0198793	03/04/2003	CO	52.0	52		M	03/04/2003	Pt states LT deltoid spasmed @ time of injection; numbing pain radiated down the LT arm.  Since that time, the pain has persisted, sometimes severe.									N	12/17/2002	12/17/2002	0		UNK	UNK		Chest congestion and cough.	COPD			1						1	Hypoaesthesia; Muscle spasms; Pain	FLU3~PFIZER\WYETH~4020021~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0198809	03/05/2003	IL	5.0	5		M	02/14/2003	Pt seen 10/23/03 with chronic cough moist likely asthma tx'd wiht Zyrtec and Advair, and given flu shot. Fever and joint c/o began 10/30/03. Persisted and developed pericardial effusion and ventricular dysfxn. Dx'd with systemic JRA later. Seeing rheumatologist. Difficult to tx. The medical records state epiglottitis.					Y	10			N	10/23/2002			ANA (-), RF (-), pericardial effusion R pneumonia with pneural eff, ng CT	PVT	PVT	Zyrtec 5mg qd, Advair 100mg bid	Chronic cough	Recurring bronchitis probable atopy			1						1	Arthralgia; Arthropathy; Cardiomegaly; Epiglottitis; Hepatomegaly; Pericardial effusion; Pyrexia; Rheumatoid arthritis	FLU3~SANOFI PASTEUR~UB903AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0198816	03/05/2003	IA	23.0	23		F	02/09/2003	Mild itching, redness, mild irritation. Now specific site redness. Limited to back, axillary, mid sternal area, no dyspnea, or other symptoms noted.									Y	02/08/2003	02/08/2003	0		MIL	MIL	Hydrocortisone	Back surgery 1 month prior				1						1	Erythema; Pruritus; Skin irritation	FLU3~SANOFI PASTEUR~U0905FA~6~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~SANOFI PASTEUR~U1073~1~IM~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0198890	03/05/2003	LA	18.0	18		F	01/20/2003	It was reported that a pt rec'd Menomune A/C/Y/W-135 (lot#UB245AA) and a Fluzone SV '02-'03 (lot #U0926BA) vaccination at 11:25am on 11/14/02. At 12:40pm that same day, a rash developed at the injection site of the L arm with itching. The pt also complained of lightheadedness. Benadryl 25mg was given by mouth. Th pt was monitored for 30 minutes. At 1:15pm, the pt's vital signs were stable and the rash was fading. The pt also denies any itching. the pt was instructed to notify a physician or be seen in ER if reaction became worse. The pt reportedly recovered from this experience and was released. This case is closed.									Y	11/14/2002	11/14/2002	0	NONE	OTH	OTH		NONE	NONE		U200201174	1						1	Dizziness; Injection site hypersensitivity; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U0926BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~SANOFI PASTEUR~UB245AA~1~SC~LA~MENINGOCOCCAL (MENOMUNE)~1	USA		Influenza
0198936	03/06/2003	GA	4.0	4		M	11/27/2002	From info received at manufacturer on 11/15/02, it was reported that a 4 y.o. male was administered Daptacel, Fluzone SV '02-'03 USP, IPOL, and MMR on 11/12/02. The child was seen in the ER later that night w/a fever of 104 deg F, and swelling and redness in both legs at the inject sites. He was diagnosed w/cellulitis. It was not reported whether the PT recovered.  Follow up on 12/03/2003: From correspondence received on 04/14/2003 from the reporter, no further information was provided.  No further information is anticipated, this case is closed.  Follow up on 01/22/04: No further information was provided. No further information is anticipated, this case is closed.				Y					U	11/12/2002	11/12/2002	0		OTH	OTH					U200201015	1						1	Cellulitis; Injection site erythema; Injection site oedema; Pyrexia	DTAP~SANOFI PASTEUR~C0890AA~UNK~~~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U0927AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W0290~UNK~~~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0770M~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0198961	03/06/2003		30.0	30		M	02/26/2003	Two spots on same shoulder auto-inoculated, likely caused by raw spots due to bandage change.									Y	02/18/2003	02/26/2003	8	NONE	MIL	MIL			NONE			1						1	Vaccination complication	FLU3~SANOFI PASTEUR~U0905FA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020071~1~~LA~SMALLPOX (DRYVAX)~1	USA		Influenza
0199055	03/07/2003	WI	18.0	18		M	03/07/2003	2/26/2003 Painful bullous rash on skin and mucous membranes.  3/1/2003 Fevers, conjunctivitis, malaise, myalgias, central headache. Diagnosed with Steven's Johnson Syndrome. Annual follow up on 03/30/04: Pt has recovered from adverse events.				Y	Y	6			U	02/06/2003	02/26/2003	20	Bulla/skin cultures negative for vaccinia, VZV, HSV, gram stain, bacterial culture, fungal smear. Fungal cultures still pending. Skin biopsy consistent with erythema multiforme, special stains negative for GMS, Gram, Fite.	MIL	MIL	patient denies	patient denies	severe nickel skin allergy			1						1	Dermatitis bullous; Erythema multiforme; Headache; Malaise; Myalgia; Pyrexia; Stevens-Johnson syndrome; Stevens-Johnson syndrome	ANTH~EMERGENT BIOSOLUTIONS~~UNK~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~unknown~1~ID~LA~SMALLPOX (DRYVAX)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~~TETANUS TOXOID, ADSORBED (NO BRAND NAME)~1|ANTH~EMERGENT BIOSOLUTIONS~~UNK~~~ANTHRAX (BIOTHRAX)~2|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~2|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0199061	03/10/2003	SD	0.75	0	.8	F	02/27/2002	Admitted to hospital with difficulty breathing, fever, croupy cough, inspratory stridor, acute bronchitis.	Y	02/10/2002			Y	1			N	11/21/2002	12/08/2002	17	Autopsy-laryngotracheitis, bronchopneumonia, ischemic brain changes.	PVT	PVT					03002	1						1	Bronchitis acute; Cerebral ischaemia; Cough; Dyspnoea; Laryngitis; Pneumonia; Pyrexia; Stridor	FLU3~EVANS VACCINES~E33472HA~1~UN~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~5355A2~3~UN~RL~HEP B (ENGERIX-B)~1	USA	Results in Death	Influenza
0199175	03/11/2003	CA	43.0	42		F	02/25/2003	Pt c/o pain upper R arm at time of injection. Increase two days later, also c/o redness and heat-lasted one week. States pain continued called 1/6/03 health dept. Was told to take Motrin, if no relief. To see physician called again 2/25/03 c/o of continuing pain outer aspect length of upper arm, difficulty raising arm. Has not seen physician even though advised to do so. Referred to clinic for medical attention.				Y					U	12/09/2002	12/11/2002	2		PUB	PUB	NONE	NONE	NONE		CA020115	1						1	Injection site erythema; Injection site pain; Injection site warmth; Joint range of motion decreased	FLU3~SANOFI PASTEUR~U0919AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0199210	03/11/2003	NY	56.0	56		F	03/04/2003	Pt got 2 shots around 11:15am. One for flu vaccine and one for pneumonia. By 2:00 or 3:00pm, pt felt listless and mentally dull. By 06:00pm, pt felt stiff in right arm and shoulder (site of shot). By 7:00pm, pt was in so much pain that she wept. This intense pain continued throughout the night. The next day, the pain in my armpit and rib cage had lessened, but still had intense pain near where she had the shots. Now about 4 days later, pt mental state has improved, but still have tenderness in my arm where she had the 2 shots to the extent that she cannot sleep on that side.									Y	02/28/2003	02/28/2003	0		PVT	PVT	HRT, Nasal Steroid, Synthroid	NONE	NONE			1						1	Musculoskeletal stiffness; Pain; Tenderness	FLU3~PFIZER\WYETH~420036~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1027M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0199311	03/12/2003	TX	53.0	53		M	03/11/2003	Body ache, flu-like symptoms that rapidly progressed. Was diagnosed with polymyositis and desquamative interstitial pneumonitis. The discharge summary states polymyositis, pulmonary fibrosis, pneumonia, staph aureus, bacteremia, cholecystitis, respiratory failure, anxiety disorder, and leukocytosis. The 60 day follow up received states polymyositis, interstial lung disease-receiving chemotherapy and steroids. Required to use oxygen 24/7. Readmitted to hospital-3 wk stay-8 days in ICU on ventilator. Must now consider medical retirement. The follow up received on 3/31/03 states, triggered: polymyositis, interstitial lung disease, MRSA, respiratory failure, original diagnosis congestive heart failure, 94 days in hospital.			Y	Y	Y	94	Y	Y	Y	11/19/2002	11/20/2002	1	Several negative-will provide data upon request	MIL	MIL		NONE	NONE			1						1	Anxiety; Apnoea; Cholecystitis; Goitre; Influenza like illness; Leukocytosis; Lung disorder; Myositis; Otitis media; Pain; Pharyngitis; Pneumonia; Pneumonitis; Polymyositis; Pulmonary fibrosis; Rhinitis; Sepsis	FLU3~SANOFI PASTEUR~U0983AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0199326	03/12/2003	UT	75.0	75		M	03/05/2003	Pain at site of injection.									N	10/28/2002	10/28/2002	0		PVT	PVT		NONE	NON			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U0981AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0199328	03/12/2003	MS	0.6	0	.6	F	02/28/2003	Pt was given IPV, DTaP, HBV, Prevnar and Flu vaccine on 2/27/03. That night she was taken to ER for 102 temp. She also experienced a seizure witnessed by mother. She has history of seizure disorder and is on Tegretol.				Y					Y	02/27/2003	02/27/2003	0	CBC, CXR in ER	PVT	UNK	Pulmicort; Xopenex; Tegretol		Asthma, seizures, status post herpes encephalitis			1						1	Convulsion; Pyrexia	DTAP~SANOFI PASTEUR~C0950AB~3~~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U0941AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~5374A2~3~~RL~HEP B (ENGERIX-B)~1|IPV~SANOFI PASTEUR~W0332~3~~RA~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~491574~3~~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0199449	03/13/2003		1.9	1	.9	M	02/27/2003	Left leg edema, erythema, ecchymosis 48 hrs post vax.				Y					Y	02/24/2003	02/25/2003	1		MIL	MIL		NONE	NONE			1						1	Ecchymosis; Erythema; Oedema	DTAP~GLAXOSMITHKLINE BIOLOGICALS~582A2~3~IM~LL~DTAP (INFANRIX)~1|FLU3~PFIZER\WYETH~402004D~2~IM~LL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|IPV~SANOFI PASTEUR~W0332~3~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|VARCEL~MERCK & CO. INC.~0865M~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0199649	03/17/2003		3.5			F		A report was rec'd concerning a child vaccinated who experienced mycobacterium avium complex (MAC) osteomyelitis an unspecified length of time after receiving influenza vaccine (brand unspecified), DTaP with hepatitis B (brand unspecified), inactivated polio vaccine (brand unspecified), oral polio (brand unspecified), and varicella vaccine (brand unspecified) on an unknown date. No BCG was administered. On an unspecified date the pt presented with a 3 month history of L lower leg pain and a 3 wk history of fevers up to 38.9C. the leg pain was constant dull ache that had increased gradually. Her pain localized over the anterior L lower leg but there was no swelling or erythema. She had a noticeable limp and avoided walking. There was no improvement with non-steroidal anti-inflammatory drugs. The was no history of previous leg pain, trauma, lymph node swelling, rash, insect bite, viral infection or joint swelling. the pt's mother had a history of recurrent MAC osteomyelitis. The pt was not toxic on physical exam but was anxious and guarded her left leg. Her temp was 38.5C, pulse 120 beats/minute, respiratory rate 28 breaths/minute, and blood pressure 85/45. the exam was remarkable for  1X1cm non tender, soft, mobile, L submandibular lymph node. Her L tibia was tender to palpation without visible edema or erythema. There was no lymphadenopathy or organomegaly. Laboratory date initially revealed a leukocyte count of 17,500 cells/mm3 with 50% lymphocytes, 37 % neutrophils and 1% eosinophils. The haemoglogin was 7.3 g/dl and the platelet count was 583,000 cell/mm3. Erythrocyte sedimentation rate (ESR) and C-reactive protein were elevated at 105 mm/hr and 8.1 mg/dl, respectively. Plain X-rays demonstrated lytic lesions of the tibia and femur. In the opinion of the reporters, the dx was unlikely to have been growing pains as massage and acetaminophen did not help. In addition, growing pains are intermittent, and she had progressive unilateral lower leg pain. Cellulitis was ruled out as there was a lack of localized swelling AND ERYTHEMA OVER THE SYMPTOMATIC AREAS. The pt's newborn screen was negative for sickle cell disease and titers were no sickle cells on the peripheral blood smear thereby excluding sickle cell disease. The presence of the lutic lesions sad the absence of joint symptoms, make JRA unlikely. There was insufficient information to determine the reporters causality assessment.				Y				Y					Chest X-ray- abnormal,purified protein derivative skin test - positive, Bronchoscopy grew acid-fast bacilli, gastric aspirate positive for MC,Radiology findings were absent for bone tumors, leukemia was unlikely since there was a lack of organomegaly and there was a relatively norm 1 complete blood cell count, even though the pt had fever and lytic lesions. The reporters felt that the pt's presentation with fever, bone pain, leukocytosis, elevated ESR, and lytic bone lesion was concerning for osteomyelitic.	UNK	UNK	Concomitant drugs not reported		2 otitis media infections, mild eczema controlled with non-steroidal cream, thigh furuncle, R lower lobe consolidation, MAC, 3mo history L lower leg pain, 3 wk fever up to 38.9C,mycobacterium avium infection.		PJP200300094	1						1	Difficulty in walking; Gait disturbance; Laboratory test abnormal; Lymphadenopathy; Osteomyelitis; Pain; Pyrexia	DTAPH~UNKNOWN MANUFACTURER~~UNK~IM~~DTAP + HIB (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|OPV~UNKNOWN MANUFACTURER~~UNK~PO~MO~POLIO VIRUS, ORAL (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~UNK~SC~~VARICELLA (NO BRAND NAME)~1	USA	Disabling	Influenza
0199740	03/18/2003	MN	68.0	67		M	02/24/2003	Received vaccine 11/6/02. Saw physician 11/8/02 with localized pain. Large area of erythema, warmth, tenderness and edema affecting the upper extremity. Pt states symptoms have slightly improved over last 12-24 hrs. Pt noticed tingling in arm on evening 1/6/02 felt like a warm fluid. Symptoms stayed constant 2 days going away on 3rd day. Now arm really really tender. Has hot flashes of arm being hot. Always tingly. The information entered in box #13 is from the documentation in the pt's medical record. However, the pt insists he was given the pneumonia shot in the right arm and that is what he reacted to. He stated the nurse told him which arm each was injected into-states he remembers his left arm bled after the flu shot and he didn't bleed after the pneumonia shot. Per 60 day follow up: It is unknown if the patient has recovered. The patient has not been seen at clinic since 11/08/2002.  Pt. returned for an influenza vaccination 11/20/03. He had no other physician visits since 11-08-02.				Y				Y	U	11/06/2002	11/07/2002	1	NONE	PVT	PVT	Tylenol with codeine 2 prn day, Elavil at HS 25mg, Triamt/HTZ 5 day	NONE	Heart surgery at age 35 ? ductus arterosus; 1986 injury to neck C5-6 followed by ?, shoulder dislocation 1983			1						1	Hot flush; Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth; Paraesthesia	FLU3~SANOFI PASTEUR~U0950AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0445M~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0199741	03/18/2003	FL	7.25	7		M	03/10/2003	A 5cm in diameter area of redness and warmth at site of Pneumovax on left upper arm.									Y	03/06/2003	03/10/2003	4		PVT	PUB	NONE	NONE	NONE			1						1	Injection site erythema; Injection site warmth	FLU3~PFIZER\WYETH~4020015~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0872M~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0199757	03/18/2003	NY	69.0	69		F	01/15/2003	Developed weakness on legs the day vax received. Continued w/weakness of legs, no strength in legs. Saw an internist. Sx's persisted and became worse on 1/14/03. Was able to see neurologist another day following internist visit. States that an MD told her that the weakness of legs is probably due to the flu shot. Being treated w/meds and PT 3x week.				Y					U	12/11/2002	12/13/2002	2		PUB	PUB		NONE	UNK		NYS23005	1						1	Constipation; Hypothyroidism; Myalgia; Myasthenic syndrome; Skin disorder	FLU3~PFIZER\WYETH~4020026~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0199759	03/18/2003	NY	52.0	52		F	11/19/2002	Client stated immediately after injection she experienced spasm pain up and down left arm (inject site), felt arm got weak. Stated it lasted approx 5 mins and Sx's went away. Stated about 11:00 weakness returned; pain returned - stated pain was spasm-like up to shoulder. Currently pain continues. Currently states she is able to move left arm - c/o shoulder hurts with movement. Denies fever, denies redness at inject site. States she has mobility of arm.									U	11/19/2002	11/19/2002	0		PUB	OTH	Rifambin and Tetracycline		Knee		NYS23002	1						1	Hypertonia; Injection site reaction; Myasthenic syndrome; Pain	FLU3~PFIZER\WYETH~4020023~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0199817	03/18/2003	MD	26.0	26		F	03/18/2003	Swollen glands (axilla) of arm where vaccine was received, 2 remote papules with central white head distant to site of vaccine (abd and left anterior chest).										03/10/2003	03/16/2003	6	NONE	MIL	UNK	NONE	NONE	History of SAR			1						1	Lymphadenopathy; Rash papular	ANTH~EMERGENT BIOSOLUTIONS~~1~SC~LA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~1~SC~RA~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~~2~IM~LA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0199846	03/19/2003	MA	86.0	86		F	11/15/2002	Two hours after she received flu shot, her arm began to hurt. Later that night, she reports severe pain in her arm. Pain lasted 3 days.				Y					Y	10/25/2002	10/25/2002	0	CXR - negative - may have shown calcium deposits	OTH	PVT	BP medication ASA	NONE	HTN, history of codeine and PCN allergy			1						1	Pain	FLU3~SANOFI PASTEUR~U0908AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0199889	03/19/2003	NJ	56.0	55		M	03/11/2003	Next day after flu shot, pt felt pain about 1 square inch around the injection point. Later in a week, the pain area expanded, but no more intense. Now the whole upper left arm feel pain if lifting or moving.									N	11/18/2002	11/19/2002	1		OTH	OTH						1						1	Injection site pain; Joint range of motion decreased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0199959	03/20/2003	MN	38.0	38		F	03/13/2003	Vaccine was given around 2 pm, by 6 am felt extremely achy, headache, wanted to stay in bed, flu like. By 11 am symptoms were completely gone.									Y	11/21/2002	11/22/2002	1		OTH	OTH						1						1	Headache; Influenza like illness; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0199977	03/20/2003	OK	47.0	46		M	03/17/2003	Large rash around shot area, prolonged rash and swelling with soreness.				Y						03/15/2003	03/19/2003	4	UNK At this time, neg, as of now, 3/18/03.	MIL	MIL				Unspecified reaction~Anthrax (Biothrax)~~47.00~In Patient		1						1	Injection site pain; Injection site rash; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~UNK~SC~~MENINGOCOCCAL (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~IM~~TETANUS TOXOID (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~IM~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0200046	03/21/2003	AK	13.0	13		M	03/21/2003	Large (4 inches in diameter)red, tender, indurated area on left deltoid where PPV 23 given. Temperature elevation of 100.4 F. Seen by medical provider 3/20 and hot packs prescribed with appointment for follow up in one or four days.				Y						03/17/2003	03/18/2003	1		PUB	PUB	No	None	None			1						1	Injection site erythema; Injection site induration; Injection site pain; Pyrexia; Unevaluable event	FLU3~SANOFI PASTEUR~OU885AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1027M~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~OU885AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1027M~1~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0200078	03/24/2003	TN	25.0	25		M	02/07/2003	Dyspnea, chest tightness, odynopliagia									Y	01/30/2003	01/30/2003	0	NONE	MIL	MIL	NONE	NONE	Saborchic Dermatitis		KY2003025A	1						1	Chest pain; Dyspnoea	ANTH~EMERGENT BIOSOLUTIONS~~1~IM~~ANTHRAX (BIOTHRAX)~1|FLU3~EVANS VACCINES~1892HA~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0200082	03/24/2003	KY	35.0	35		M	03/16/2003	2nd Anthrax vax administered ?? at 14:00. Noted to have short swelling 24 hrs later. Presented today with moderated edema/erythema to upper arm from shoulder to elbow. Warmth right = 35 cm, left = 30 cm red arm measure? circulatory/ ?? implement Treated w/steroid, Benadryl.										01/14/2003	01/15/2003	1		MIL	MIL	NONE				KY2003024A	1						1	Erythema; Oedema; Vasodilation procedure	ANTH~EMERGENT BIOSOLUTIONS~~3~SC~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0200137	03/25/2003	IN	62.0	63		M	03/12/2003	This pt came to office for flu and pneumonia shot. Within 24 hrs pt had red blotches all over with itching he assumed it was from flu/Pneumo shot. Rash continue to get worse seen primary care doctor on 12/8/02 has had numerous office visit with primary care MD. Today's date 3/11/03-pt continues to have a rash but is seeing dermatologist agreed on a strict diet. Pt ahs not been able to work for three months due to rash.										12/05/2002	12/06/2002	1	UNK	UNK	UNK			Only allergy is to Penicillin. No food allergies. History of coronary artery disease and had coronary artery bypass.			1						1	Rash	FLU3~SANOFI PASTEUR~U0928AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0541M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0200141	03/25/2003	CA	76.0			F	03/11/2003	Pain in Rt arm on at injection site continues can still see puncture at site pain from shoulder to elbow unable to lift or carry or sweep no fever chills or redness site jerks red when heat applied. Pt has seen PMD x 3.				Y					U				X-ray of arm neg.	OTH	PUB	Procardia Advil	NONE	NONE			1						1	Hypokinesia; Injection site pain; Pain	FLU3~SANOFI PASTEUR~U0885AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0200161	03/25/2003	SC	20.0	20		F	03/12/2003	Client at ACHD for immunizations for foreign travel.  History of fainting. Lay down for injections for 20 minutes past vaccine then sat in chair for 10 minutes. Became pale and  diaphoretic. Reclined 30 min then ambulatory with BP 104/64 pulse 68 versus 82/54 pulse 64. Discharged to home accompanied by mother.									Y	03/11/2003	03/17/2003	6		PUB	PUB	NONE	NONE			SC0308	1						1	Hyperhidrosis; Hypotension; Pallor	FLU3~PFIZER\WYETH~4020027~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~SMITHKLINE BEECHAM~5299A4~1~IM~RA~HEP B (ENGERIX-B)~1|HEPA~SMITHKLINE BEECHAM~720A4~1~IM~RA~HEP A (HAVRIX)~1|TD~SANOFI PASTEUR~U0821AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0200046	03/26/2003	AK	13.0	13		M	03/26/2003	Follow up reporting. Seen by MD and hotpacks ordered. Contacted staff at place of residence and was informed that symptoms releved with hot packs for three days.				Y					Y	03/17/2003	03/18/2003	1		PUB	PUB	nONE	nONE	nONE			1						2	Injection site erythema; Injection site induration; Injection site pain; Pyrexia; Unevaluable event	FLU3~SANOFI PASTEUR~OU885AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1027M~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~OU885AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1027M~1~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0200255	03/26/2003	AZ	64.0	64		F	03/18/2003	Polymyalgia rheumatica, temporal arthritis - approx 2 wks after influenza vax.				Y					U	10/18/2002	11/01/2002	14	Sed rate 47; C-Reactive Protein 59.6	OTH	PVT			HTN, Osteoporosis			1						1	Arteritis; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0200308	03/26/2003	CO	39.0	39		M	03/26/2003	8 days after immunization had erythema surrounding site with axillary adenopathy and fever 102F.				Y					Y	03/18/2003	03/24/2003	6		MIL	UNK		none	allergy to penicillin			1						1	Injection site erythema; Lymphadenopathy; Pyrexia	ANTH~MICHIGAN DEPT PUB HLTH~~UNK~~~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0200453	03/27/2003	GA	63.0	63		F	03/27/2003	Extreme pain, loss of ROM in left arm/shoulder,loss of strength in left arm, radiating pain to neck & fingers. Tx. ASA & heating pad										11/07/2002	11/07/2002	0		PVT	UNK						1						1	Asthenia; Joint range of motion decreased; Pain; Asthenia; Joint range of motion decreased; Pain	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|FLU3~PFIZER\WYETH~4020002~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0198739	03/28/2003	NY	65.0	65		F	03/21/2003	Within 15 minutes after shot-the area swollen to the size of 1/2 dollar. Arm was red swollen from elbow to over top of shoulder. Pain very bad that evening. The swelling was double in size and hard as a rock. Next day went to MD. Nurse said swelling is expected but would go down. Don't worry about it. Swelling did not start going down as well as redness until 2 wks later. During that time I called the office and they assessed me all was OK. Finally was able to see a MD 12/09/2002 - 01/02/2002  01/05/2003 ER  MD again 01/09/2003 - 01/22/2003. Ungodly pain from day one. Orthopedic 01/13/2002, 01/27 and 02/28/2003.				Y					U	10/23/2002	10/23/2002	0	12/13/2002 shoulder x-ray (inflammation) ER 01/5/2003 x-ray (inflammation shoulder) 01/13 MRI (Excessive amount of fluid) 01/05/2003 Blood test (some infection in blood)	PVT	OTH		Back, neck pain				1						2	Injection site induration; Injection site pain; Swelling; Injection site erythema; Injection site induration; Injection site oedema	PPV~MERCK & CO. INC.~O111M~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0200430	03/28/2003	CO	51.0	51		F	03/19/2003	Upset stomache, headache, achy all over, metallic taste in mouth. All for a couple days.									Y	11/21/2002	11/22/2002	1		OTH	OTH	UNK	UNK	UNK			1						1	Dysgeusia; Headache; Pain; Stomach discomfort	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0200498	03/30/2003	MO	33.0			M	03/30/2003	Chest pain, onset upon wakening. Treated at a military Community Hosp, transferred to a Hospital. Elevated troponin. ECG changes. Catheter--normal coronaries. Recovered after 2-night hospitalization.					Y	3			Y	02/28/2003	03/12/2003	12		MIL	MIL						1						2	Chest pain; Laboratory test abnormal; Myocarditis; Chest pain	ANTH~EMERGENT BIOSOLUTIONS~FAV072~UNK~~~ANTHRAX (BIOTHRAX)~1|FLU3~PFIZER\WYETH~4020040~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~SMITHKLINE BEECHAM~5305A6~UNK~~~HEP B (ENGERIX-B)~1|HEPA~SMITHKLINE BEECHAM~746A2~UNK~~~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~W0620~UNK~~~POLIO VIRUS, INACT. (IPOL)~1|MEN~SANOFI PASTEUR~UB273AA~UNK~~~MENINGOCOCCAL (MENOMUNE)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1|SMALL~PFIZER\WYETH~4020071~1~~~SMALLPOX (DRYVAX)~2	USA	Hospitalisation	Influenza
0200533	03/30/2003	PA	55.0	55		F	03/29/2003	prolonged soreness at injection site.  Entire body muscle ache within one week, lasting one week.  Both upper arms remained painful.  Treated with MOTRIN, with no effect.  Cortisone injections had no effect.  Condition subsequently diognosed as  Bi-Lateral rotator cuff tendonitis.  Currently undergoing PT.									N	10/02/2002	10/02/2002	0	MRI, X-rays,Lab work(R.A., Lyme, etc.)	PVT	PVT		None	None			1						1	Injection site pain; Myalgia; Pain; Tendonitis	FLU3~PFIZER\WYETH~4020012~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0200498	03/31/2003	MO	33.0	33		M	03/21/2003	Smallpox related myocarditis, chest pain, Troponin up to 20 day 12 of smallpox. See executive summary 3/13/03.			Y	Y	Y	3			Y	02/28/2003	03/12/2003	12	Troponia up to 20; Cardiac cath negative; Positive EKG's; PPD	MIL	MIL	PPD	NONE	NONE			1						1	Chest pain; Laboratory test abnormal; Myocarditis; Chest pain	ANTH~EMERGENT BIOSOLUTIONS~FAV072~UNK~~~ANTHRAX (BIOTHRAX)~1|FLU3~PFIZER\WYETH~4020040~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEP~SMITHKLINE BEECHAM~5305A6~UNK~~~HEP B (ENGERIX-B)~1|HEPA~SMITHKLINE BEECHAM~746A2~UNK~~~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~W0620~UNK~~~POLIO VIRUS, INACT. (IPOL)~1|MEN~SANOFI PASTEUR~UB273AA~UNK~~~MENINGOCOCCAL (MENOMUNE)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1|SMALL~PFIZER\WYETH~4020071~1~~~SMALLPOX (DRYVAX)~2	USA	Life Threatening,Hospitalisation	Influenza
0200511	03/31/2003	TX	44.0	44		M	11/03/2002	Chills and subjective fever which began 10 hours after administration. During; 5 hours.									Y	10/19/2002	10/19/2002	0	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Pyrexia	FLU3~SANOFI PASTEUR~0984AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0199055	04/01/2003	WI	18.0	18		M		Steven's-Johnson Syndrome reaction to smallpox vaccine. Follow up on 06/04/2004: states it is unknown whether pt recovered from the adverse events. I believe pt was transferred and heard that he did recover but am not absolutely positive.				Y	Y		Y		U	02/06/2003	02/26/2003	20	CH 50, C3, C4, CIQ, and Raji cell assay; CBC, CMP, Chest X-ray	MIL	MIL	NONE	NONE	NONE			1						2	Dermatitis bullous; Erythema multiforme; Headache; Malaise; Myalgia; Pyrexia; Stevens-Johnson syndrome; Stevens-Johnson syndrome	ANTH~EMERGENT BIOSOLUTIONS~~UNK~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~unknown~1~ID~LA~SMALLPOX (DRYVAX)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~~TETANUS TOXOID, ADSORBED (NO BRAND NAME)~1|ANTH~EMERGENT BIOSOLUTIONS~~UNK~~~ANTHRAX (BIOTHRAX)~2|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~2|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0200598	04/01/2003	MA	48.0			F	03/24/2003	Pt called on 3/24/03 to state she believes to have acquired arthritis as a result of receiving the flu vaccine.									U				Unsubstantiated	PUB	PVT		NONE	NONE			1						1	Arthritis	FLU3~SANOFI PASTEUR~U0924DA~1~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0200669	04/01/2003	IL	19.0	19		M	03/25/2003	VAsovagal syncope, orthostatic hypotension, dehydration.				Y					Y	01/28/2003	01/28/2003	0		MIL	MIL						1						1	Dehydration; Orthostatic hypotension; Syncope vasovagal	ANTH~EMERGENT BIOSOLUTIONS~FAV073~UNK~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~HEP A + HEP B (TWINRIX)~1|SMALL~PFIZER\WYETH~4020071~UNK~~~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|YF~UNKNOWN MANUFACTURER~~UNK~~~YELLOW FEVER (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0200670	04/01/2003	IL	38.0	38		F	03/25/2003	Probable viral URI/sinusitis. Possible delayed reaction to immunizations. Follow up information received 04/21/2003 states: left axillary pain, lymphadenitis, etiology unknown.				Y					Y	02/16/2003	02/23/2003	7		MIL	MIL						1						1	Lymphadenitis; Pain; Sinusitis; Upper respiratory tract infection	ANTH~EMERGENT BIOSOLUTIONS~FAV070~UNK~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|SMALL~PFIZER\WYETH~4020071~UNK~~~SMALLPOX (DRYVAX)~1|YF~UNKNOWN MANUFACTURER~~UNK~~~YELLOW FEVER (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0200671	04/01/2003	IN	38.0	38		F	03/25/2003	Fever, headaches (most likely viral resp. infection/sinusitis).				Y					Y	02/14/2003	02/21/2003	7		MIL	MIL						1						1	Headache; Pyrexia; Sinusitis; Upper respiratory tract infection	ANTH~EMERGENT BIOSOLUTIONS~~UNK~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1|YF~UNKNOWN MANUFACTURER~~UNK~~~YELLOW FEVER (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0200719	04/02/2003	WI	86.0	86		F	03/26/2003	Pt was hospitalized with acute onset thrombocytopenia one day after receiving flu vaccine. She had bruising around vaccine site, petechial rash and platelet count < 5,000. She was treated with IVIG x 6 days plus steroids. She had been previously very healthy.			Y	Y	Y	11			Y	11/03/2002	11/04/2002	1	11/4/02 platelets < 5,000, normal morphology 11/12 plt 8,000 11/15 plt 39,000	OTH	OTH	Acetaminophen tabs qd occasional aspirin use	NONE	NKDA. History of arthritis, hysterectomy, toe removal			1						1	Contusion; Petechiae; Platelet count decreased; Thrombocytopenia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0200721	04/02/2003	VA	26.0	25		M	03/24/2003	Pt states dx of rt. sided encephalitis; subsequent LLE DVT. 12/11/03 received flu immunization at workplace setting. Note: MD remembers this as being given on 12/18/02. Our consent form and clinic tracking records all clearly state 12/11/02. MD states he felt he had a kind of a cold several days prior to the clinic, as well as on the day of the clinic. Denies any fever or congestion, but did have a sore throat and blocked nose. States he has a history of frequent colds. After screening, the nurse told him it was appropriate to have the immunization. 12/19/03 developed a fever. Did not take temperature, but felt hot. Self-treated with Tylenol. Note: MD feels this was actually one day after he received the immunization. 12/22/03 developed shivering hands, fell down/collapsed. Also complained of feeling dizzy and having a fever. Drove to urgent care center for treatment, transferred to hospital. Was in a coma for the next seven days; eventually diagnosed with encephalitis on the right side of the brain. Hospitalized for total of 9 days. One week post-discharge, readmitted to hospital for left lower leg DVT. Hospitalized for total of 10 days. Post-hospitalization required a month of home physical therapy to regain strength in left leg. Was on coumadin therapy, but switched to heparin injections on 3/20/03. Leg remains swollen and is unable to walk long distances. Has returned to work but has decreased stamina. The discharge summary received on 1/2/04 states chills, weakness, seizure, psychosis.					Y	9			Y	12/11/2002	12/22/2002	11	Patient states diagnosis of Right sided encephalitis; subsequent LLE DVT. Labs abnormal.	OTH	PVT	UNK		Mental changes			1						1	Asthenia; Chills; Coma; Convulsion; Deep vein thrombosis; Dizziness; Encephalitis; Laboratory test abnormal; Loss of consciousness; Myalgia; Psychotic disorder; Pyrexia	FLU3~SANOFI PASTEUR~U0938AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0200723	04/02/2003	KS	62.0	62		M	12/27/2002	Weakness, pain, numbness in left leg. Spread up leg into groin; diagnosed by neurologist as Guillian Barre. Treatment: IVIG 400mg/kg/day for 4 days, then plasmaphoresis for 6 treatments, Neurontin, Tegretol, Narcotic pain control. The discharge summary states Staphylococcus sepsis.					Y	23			Y	11/15/2002	12/02/2002	17	CSF Protein 59mg/dl	PUB	PUB	Mevacor; Glucophage; Lisinopril; Avandia; Aspirin; Folic Acid; Multivitamin		Diabetes Type II, Coronary artery disease, sleep apnea		KS200302	1						1	Asthenia; Guillain-Barre syndrome; Hypoaesthesia; Pain; Sepsis	FLU3~SANOFI PASTEUR~U0946AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0200738	04/02/2003	WI	41.0	41		M	03/25/2003	Possible reaction to immunization (jittery, heart racing, possible anxiety rx)				Y						02/08/2003	02/10/2003	2		MIL	MIL						1						1	Anxiety; Feeling jittery; Heart rate increased	ANTH~EMERGENT BIOSOLUTIONS~FAV073~UNK~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0200780	04/02/2003	MO	34.0	34		F	03/25/2003	Generalized inflammatory response to immunization (nausea, sore neck, flushed, blurred vision, chills)				Y					Y	02/02/2003	02/02/2003	0		MIL	MIL						1						1	Amblyopia; Chills; Nausea; Pharyngitis; Vasodilation procedure	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0200843	04/03/2003	KS	1.8	1	.5	F	03/24/2003	Raised, red, vesicular rash in patches over left cheek, left side of neck, upper left posterioir, or shoulder around left ear.									Y	12/06/2002	02/27/2003	83	NONE	PVT	PVT					KS200319	1						1	Rash erythematous; Rash vesicular	FLU3~SANOFI PASTEUR~U0929AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0813M~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~490368~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0490M~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0201022	04/07/2003	PA	33.0	33		F	04/07/2003	One hour after receiving hepatitis B vaccine and flu vaccine, patient became agitation, with mental status changes with no clear cause, headache with a stiff neck, overall malaise, myalgia and a fever. Patient admitted for observation. Given acetaminophen and tests were performed to rule out an infectious process.					Y	3			Y	10/15/2002	10/15/2002	0	All cultures were negative, lab values were esentiallynormal.	UNK	UNK		HIV positive x 8 years	HIV positive x 8 years, asthma			1						1	Agitation; Headache; Malaise; Mental impairment; Musculoskeletal stiffness; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~Not Known~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~Not Known~1~~~HEP B (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0200453	04/09/2003	GA	63.0	63		F	03/31/2003	Extreme pain left arm, radiating to neck and fingers. Loss of strength and degree of range of motion to left shoulder for 6 months. Treatment: ASA and heating pad.									N	11/07/2002	11/07/2002	0		PVT	UNK	Premarin; HCTZ		NONE			1						2	Asthenia; Joint range of motion decreased; Pain; Asthenia; Joint range of motion decreased; Pain	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|FLU3~PFIZER\WYETH~4020002~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA		Influenza
0201145	04/09/2003	WI	31.0			F	04/01/2003	An initial report was received at manufacturer on 3/26/03 from a patient from the USA. Two provisional diagnoses are reported: asthma attack and just co-incidental event according to the Pulmonologist; systemic possible allergic reaction according to the patient's physician. The patient, 31 year old female, developed chest tightness, headache and disorientation, wheezing, and a 50mmx70mm area of redness with pain at injection site the evening after the injection of Fluzone, requiring 2.5 days of hospitalization. The patient received a flu shot in December 2002 with no reactions. The patient's physician feels that she had a systemic possible allergic reaction. Pulmonologist opinion is that the symptoms were an asthma attack and just co-incidental. She received oral and IV steriods, tenalog, breathing treatments, xanax for spasms and Vicoden for pain. Chest tightness, wheezing and shortness of breath continue. Local burning and pain at injection site at time of administration. Outcome not reported.				Y	Y				U	02/03/2003	02/03/2003	0		MIL	UNK			Asthma		200300016	1						1	Chest discomfort; Disorientation; Dyspnoea; Headache; Hypersensitivity; Injection site erythema; Injection site pain; Wheezing	FLU3~SANOFI PASTEUR~U0988AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0201164	04/09/2003	OH	49.0	49		F	03/27/2003	Pain in arms, drowsiness.			Y	Y				Y	Y	03/20/2003	03/21/2003	1		PUB	PUB	NONE	Flu	Tuberculosis, Diabetes, HBP, GERD hyperliperdemia. Glaucoma COPD psychosis			1						1	Pain; Somnolence	FLU3~SANOFI PASTEUR~U0909AA~4~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Disabling	Influenza
0201209	04/09/2003	ME	8.0	9		F	04/07/2003	No fever. 4-5 rash on the site. Sites flat. Difused together (as of 04/08/2003) and scar by a bug bit spot.									Y	03/26/2003	04/07/2003	12		PUB	PUB	L-Buterol, Advair, Zertec,	NONE	Allergy		ME03013	1						1	Rash	FLU3~SANOFI PASTEUR~U0904CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0450M~UNK~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0201338	04/11/2003	RI	1.0	1	.1	M	04/02/2003	Rash noted 9 days after vaccine. Multiple discrete erythematous macular, slight raised lesions post neck, post auricular, torso, and back. Fading lesions upper arms, thigh.									Y	03/03/2003	03/12/2003	9	NONE	PVT	UNK	NONE	Fever 3 days prior	Hydrocephalus			1						1	Rash erythematous; Rash macular; Rash maculo-papular	FLU3~SANOFI PASTEUR~U0911BA~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~2071M~UNK~~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0201412	04/12/2003	TX	25.0	25		M	04/12/2003	Approximately 2-3 days after first vaccination I had started to have frequent urination, uncontrollable thirst, headaches, trouble sleeping. Before second vaccination on 21 January 2003,I had notified Chief at Clinic that I was having these symptoms, and I had asked him if the anthrax vaccine could possibly cause these symptoms. He stated no, but it sounded like I may have diabetes. He suggested I make an appointment to be seen. After the second vaccination I started to have blurred vision,and noticed considerable weight loss within the past two weeks. The first vaccination was on the 6th of January,and the second on the 21st of January. I was seen on the 23rd of January by Maj. He notified me that my Blood Glucose Level was considerably high, and I needed to be sent to a hospital right away. I was then driven by my squad leader to hospital where I was taken to the emergency room for evaluation and treatment. I was then admitted to the hospital from the 23rd of January until the 27th of January. I met with numerous doctors,and diabetic educationers. I was released with a P3 profile,and instructed to come back to see my doctor Dr. approximately two weeks later. Currently I am on Gluboride, Pioglitizone, metphormine, lisinopril, and NPH(Insulin).				Y	Y	3			N	01/06/2003	01/08/2003	2	I have had numerous tests to include test of the liver,and pancreas both test were normal. Blood was also taken from the artery to determine acid levels. Currently I was given tests to determine how my pancreas is working, and also another test to check my circulation in my legs I don't know the names of these tests,but they are all documented by my current doctor.	UNK	MIL		Just Recovered From Flu like symptoms from Field Training exercises to include laryngitis.				1						1	Blood glucose increased; Diabetes mellitus; Headache; Insomnia; Pollakiuria; Thirst; Vision blurred; Weight decreased	ANTH~EMERGENT BIOSOLUTIONS~FAV066~1~SC~~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U0984AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0201469	04/15/2003		49.0	49		M		Within 24 hours of influenza virus vaccine, developed ataxia and slurred speech - progressive over 72 hours. Admitted 9 days local hospital and transferred to another hospital for 3 additional days. Numerous nl ct and MRI, head, numerous labs and procedures to include LP - grossly normal - improving with outpatient speech and physical therapy.					Y	12			U	12/03/2002	12/04/2002	1		MIL	MIL	Motrin	NONE	Allergy to PCN			1						1	Coordination abnormal; Dysarthria	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0201556	04/15/2003	CA	47.0	47		F	04/15/2003	Shortly after the vaccine, I noticed a darkening in gums.  I went to the dentist and a dental oral surgeon to have lichen planus diagnosed in the gum area.  This was I also have a rash on my stomach that has not been diagnosed.									N	12/01/2001	01/10/2002	40	Oral lichen planus	UNK	PVT		None known.	Breast cancer			1						1	Rash	FLU3~SANOFI PASTEUR~VO694AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0201576	04/16/2003	UT	84.0	84		F	04/08/2003	On 04/07 patient received pneumonia and flu shot in left arm IM. That same day, patient's arm swelled from site of injection to elbow turning red and skin warm.									U	04/07/2003	04/07/2003	0	NONE	PUB	PUB	Monopril; HCTZ; Baby Aspirin	NONE	HBP			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~PFIZER\WYETH~4020026~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1196M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0201690	04/17/2003	WI	43.0	43		F	04/12/2003	Left CVA - headache, weakness, numbness, speech slurring, left face asymmetry.				Y						03/21/2003	03/30/2003	9	Temp 96.5	MIL	MIL	Vioxx, Premarin		Rheumatoid arthritis			1						1	Asthenia; Headache; Paraesthesia; Pyrexia; Speech disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0201709	04/18/2003	NY	88.0	88		M	11/15/2002	PT visited office on 11/14/02 at 14:30. Presented with c/o itching and rash to lower extremities. He received the influenza vax on 11/12/02. His daughter called a health department on 11/13 and talked to the OD. He presents today and feels that the itching and rash are related to the influenza vax. He has not taken any Benadryl as recommended by the OD. The rash is restricted to the lower extremities. He states when the areas of rash first break out white raise pustules are visible. Reporter did not see any during this visit. PT has prickly red raised patches ranging in size from 1 cm round to 6 cm round on his lower extremities, more so on his ankle areas than upper leg areas. There is no visible reaction near inject site of flu vax. PT denies any difficulty w/breathing. PT also denies having contact w/any plant, animal, new soap, etc, that may have caused a rash to lower extremities. PT was seen by an MD who could not rule out the potential of a reaction to the flu vax. PT was instructed to take Benadryl for the itching and should his condition worsen return for evaluation. He does admit that the rash he is experiencing does seem better than the previous day.										11/12/2002	11/13/2002	1	NONE	UNK	UNK			NKA, hypothyroidism, esophageal reflux, Schizophrenia			1						1	Pruritus; Rash; Rash maculo-papular; Rash pustular	FLU3~PFIZER\WYETH~4020027~UNK~IM~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0201710	04/18/2003		80.0	80		M	04/04/2003	Typed note: We received a flu shot on 10/16/02. About 1 mt after the shot, the muscle at the point of shot became very painful, eminating burning and stinging of the arm from the muscle down to the hand. Had pain in the left neck, on the side of the head, a light fever. After a couple of months fever and headache subsides. Almost 6 mts still have muscle pain, stinging burning of arm. Nothing showed on x-ray or blood test...										10/16/2002	10/16/2002	0	X-ray, blood test - nothing showed	UNK	UNK						1						1	Injection site inflammation; Injection site pain; Neck pain; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U0919AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0201780	04/18/2003	CO	19.0	19		M	04/14/2003	Myalgia, malaise left axillary adenopathy				Y					Y	01/28/2003	02/01/2003	4	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Lymphadenopathy; Malaise; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0201943	04/22/2003	CA	28.0	28		M	04/11/2003	On 12/23/02 c/o abdominal pain but not much change till sent out to hosp 1/2/03 due to ascending weakness. Dx by MD as Guillain Barr‚ syndrome. Given IVIG 2 gram/kilo over five days. Returned to prison. Currently paralyzed but no breathing problems and can wiggle fingers and toes. Some improvement. Follow up: No additional information reported.				Y	Y	6		Y	Y	12/02/2002	12/23/2002	21	Lumbar puncture done. CSF consistent with GBS	OTH	PUB	Phenytoin, Cipro, Enoxaparin, Tylenol, Sevelamen, Epocrit, Nepro, Nifidipine, Atenolol	End stage renal disease; on dialysis since age 11.	Congenital urologic abnormality; Chronic anemia; Pancreatitis; Seizure history			1						1	Abdominal pain; Asthenia; Guillain-Barre syndrome; Paralysis	FLU3~SANOFI PASTEUR~U0883AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0202012	04/22/2003	RI	78.0	77		F		During the routine visit on 3/7/03 she reportedly experience fever and weakness in both legs for 2 months.  Pt had no explanation why she didn't contact me.  That resolved since.  On 3/7/03 initiated tx for depression with somatic components.									Y	10/25/2002				PVT	OTH	Capoten, Praveclus, aspirin	NONE	Codeine allergy			1						1	Depression; Muscular weakness; Pyrexia; Depression; Muscular weakness; Pyrexia	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~~2~IM~~PNEUMO (PNEUMOVAX)~1|FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~~UNK~SC~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0202088	04/23/2003	OH	55.0	54		F	04/16/2003	I have continued to have a deep burning sensation in my left upper arm - mild to moderate discomfort.  As the months have gone by the area is slightly larger. The discomfort about the same.									N	10/16/2002	10/17/2002	1		MIL	MIL		NONE	High blood pressure, high cholesterol			1						1	Discomfort; Skin burning sensation	FLU3~EVANS VACCINES~E35452HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0202154	04/24/2003	MD	32.0	32		F	04/24/2003	Denies unusual local or systemic reaction between 3/19 and 3/30/03. On 3/31/03, patient had new onset seizure-like activity lasting approximately 3 minutes. Witness described patient becoming unresponsive, with legs extended out and stiffened, and arms flexed, upright and shaking. Eyes rolled straight back in head, not deviated. No neck deviation. On 4/17/03 (10 days after 2nd Anthrax), patient had 2nd similar episode of witnessed seizure like activity, only L) leg was bent and both arms were flexed with fists above head, shaking. Pt. evaluated by Neuro on 4/18/03 - Impression: Seizure, likely GTC/recent vaccination may play a role. No suggestion of encephalitis. MRI and EEG ordered (pending). Started on Carbamazepine 200mg BID and given 6 month profile limiting duties. Follow up: Pt has not received additional anthrax vaccines. She has experienced two additional seizures episodes since her last VAERS was reported; both episodes had precipitating factors.  Current problem list: Seizure disorder, left shoulder pain.									U	03/19/2003	03/31/2003	12	On 3/31/03, patient seen in ER: Head CT, ECG and drug screen were neg. CBC, UA and chem panel NL. EEG and MRI with Gad, pending.	MIL	MIL	Carbamazepine	Mild URI	Vitiligo Irregular menses Allergic to dust and pollen (patient states, not physician diagnosed)			1						1	Coma; Convulsion; Eye movement disorder; Musculoskeletal stiffness; Pain; Tremor	ANTH~EMERGENT BIOSOLUTIONS~FAV069~1~SC~RA~ANTHRAX (BIOTHRAX)~1|DT~BSI~40523AA~UNK~~~DT ADSORBED (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~015M~UNK~~~MENINGOCOCCAL (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4020071~1~~~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~U1511~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0202260	04/28/2003	IN	40.0	40		M	04/14/2003	4/4/03: heartburn in AM, resolved after eating small portion of milk and crackers. 4/5/03: Awaken shortly after midnight with SOB, chest pain and diaphoresis. Transferred to ER, had V-tach episode in ER. Transferred to hospital.			Y	Y	Y	3			Y	03/25/2003	04/04/2003	10		MIL	MIL	Celebrex (PRN)	NONE	NONE			1						1	Chest pain; Dyspepsia; Dyspnoea; Hyperhidrosis	ANTH~EMERGENT BIOSOLUTIONS~~1~~RA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~1~~RA~HEP A (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4020071~3~~LA~SMALLPOX (DRYVAX)~1|TD~UNKNOWN MANUFACTURER~~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~RA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0202285	04/29/2003	AR	13.0	12		M	03/05/2003	Eczematous rash appeared at injection site the day after the injection. Remained for 4 months.									Y	11/04/2002	11/05/2003	366	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Eczema; Injection site rash	FLU3~EVANS VACCINES~E30422GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0202323	04/29/2003	NY				F	01/14/2003	A pharmacist reported that a female patient received an injection of FluShield (influenza virus vaccine, trivalent, types A & B (2002-2003 formula) on 03-JAN-2003 in the left arm.  On 04-JAN-2003, the reporter indicated the patient was seen in an emergency department; a diagnosis of cellulitis was made.  The pharmacist stated that the cellulitis was coincident with the FluShield administration.  The patient was instructed to apply warm compresses to the area  and take Keflex (cefalexin monohydrate) as directed.  No further information was available at the date of this report.				Y					U	01/03/2003	01/03/2003	0	UNK	PUB	OTH	UNK	UNK	UNK		HQ6054807JAN2003	1						1	Cellulitis	FLU3~PFIZER\WYETH~4020019~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0202324	04/29/2003	NY				M	04/14/2003	Additional information received on 03-FEB-2003 from a healthcare professional provided additional adverse event information, concomitant vaccine therapy, and recovery status.  Information was received from a nurse concerning a male patient who received FluShield (influenza virus vaccine, trivalent, types A & B (2002-2003 formula) on 19-NOV-2002.  On 18-NOV-2002, he received a booster dose of tetanus toxoid (Aventis).  On 20-NOV-2002, he developed a red, itchy rash beginning on both arms, that progressed to all areas of the body below the neck.  the patient was treated with Claritin (loratadine) which provided fair results.  the patient was subsequently examined by a dermatologist.  Skin testing and a lesion biopsy were performed.  The physician's evaluation failed to identify the cause of the dermal eruption.  The patient recovered.				Y					Y	11/19/2002	11/20/2002	1	Biopsy NOS (LLT: Biopsy NOS) Biopsy of a lesion was unable to identify etiology of dermal eruption. Skin test (LLT: Skin test) Unable to identify etiology of dermal eruption.	PVT	OTH	UNK	UNK	UNK		HQ6055407JAN2003	1						1	Erythema; Pruritus; Rash	FLU3~PFIZER\WYETH~4020021~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0202325	04/29/2003	DE				F	02/13/2003	Information has been received from a healthcare professional concerning a female patient who received a dose of flu-Shield (influenza virus vaccine, trivalent, types A & B 2002-2003 formula) on 23-OCT-2002.  On 24-OCT-2002, one day post-immunization, the patient developed an injection site reaction which consisted of massive discoloration extending from the injection site to the elbow of the affected arm.  The patient went to the emergency room.  the reporter had no further information at the date of this report.				Y					U	10/23/2002	10/24/2002	1	UNK	OTH	OTH	UNK	UNK	UNK		HQWYE093230JAN03	1						1	Injection site reaction; Skin discolouration	FLU3~PFIZER\WYETH~4020017~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0202326	04/29/2003	TX				M	01/06/2003	A healthcare professional reported that he received a dose of influenza virus vaccine (manufacturer unknown) in November, 2002.  he subsequently developed hives which have persisted for the past 8 weeks.  He was seen by his physician who prescribed Zyretec which has improved but not resolved this condition.  At the date of the report no further information was available.				Y					U	11/01/2002	11/01/2002	0	UNK	OTH	OTH	UNK	UNK	UNK		HQ6027006JAN2003	1						1	Urticaria	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0202327	04/29/2003	MT	56.0			F	02/06/2003	A nurse reported that on 13-NOV-2002, A 46-year-old female received injections of Flu-Shield (2002-2003 Formula), and PneumoVax 23 (MSD) vaccines.  On 14-NOV-2002, she developed a fever of 103 deg. F.  She recovered.  this is 1 of 3 patients from this facility who experienced fever following receipt of Flu-Shield (2002-2003 Formula) lot 4020024.									Y	11/13/2002	11/14/2002	1	UNK	PUB	OTH	UNK	UNK	UNK		HQWYE230506FEB03	1						1	Pyrexia	FLU3~PFIZER\WYETH~4020024~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0735M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0202328	04/29/2003	MT	55.0			F	02/06/2003	A nurse reported that on 13-NOV-2002, a 55-year-old female received injections of Flu-Shield (2002-2003 Formula) and PneumoVax 23 (MSD) vaccines.  On 14-NOV-2002, she developed a fever of 103 deg. F.  She experienced fever following receipt of Flu-Shield (2002-2002 Formula) lot 4020024.									Y	11/13/2002	11/14/2002	1	UNK	PUB	OTH	UNK	UNK	UNK		HQWYE230606FEB03	1						1	Pyrexia	FLU3~PFIZER\WYETH~4020024~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0735M~UNK~IM~LL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0202329	04/29/2003	MD	55.0	55		F	03/11/2003	A 55-year-old female consumer reported that she received influenza virus vaccine, trivalent, types A & B (2002-2003 formula) (manufacturer unknown) on 24-OCT-2002.  Concomitant therapy included levothyroxine sodium (Synthroid), estradiol (Estrace) and medroxyprogesterone acetate (Provera).  Medical history included allergies to sulfa drugs and sulfites, and hypothyroidism.  Within 2 days of receiving the flu vaccine, the patient experienced intense itching all over body, such that she scratched her skin raw.  Treatment included oral and topical steroids, but the patient stated the steroids made it worse.  She discontinued treatment after one week.   The patient stated the itching resolved spontaneously in mid-December 2002.									Y	10/24/2002			UNK	OTH	PVT	Estrace Provera Synthroid	UNK	CONCURRENT CONDITIONS: Drug hypersensitivity (LLT: Drug hypersensitivity) Hypersensitivity NOS (LLT: Hypersensitivity NOS) Hypothyroidism (LLT: Hypothyroidism)		HQWYE964110MAR03	1						1	Pruritus	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0202330	04/29/2003		55.0	55		F	03/18/2003	Information has been received from a business partner via a consumer regarding a 55-year-old female with a history of rheumatoid arthritis who had been receiving injections of Enbrel (etanercept) since 01/01/2000. Concomitant medications included: methotrexate, folic acid, calcium, nabumetone, estradiol, medroxyprogesterone acetate, and hydrocodone. In Sept 2002, the pt developed an unspecified intervertebral disc disorder requiring epidural treatment. In Dec 2002 the pt developed bronchitis which resolved. One week later she developed urticaria on her abdomen and lower extremities following the receipt of an influenza vaccine (manufacturer unknown). The urticaria resolved within 6 days. See related case, HQWYE606224FEB03.									Y	12/01/2002	12/01/2002	0		OTH	OTH	Calcium, Enbrel, Estradiol, folic acid, Hydrocodone, Medroxyprogesterone acetate, methotrexate, nabumetone	Rheumatoid arthritis	Unknown		984711	1						1	Bronchitis; Urticaria	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0202610	05/06/2003	CA	31.0	31		M	04/06/2003	Received flu shot as an outpatient 12/12. Came to ER at 21:26 with SOB, wheezing, severe hypoxia. Received 6 respiratory treatments with albuterol, solumedrol, and Alocort. Almost required intubation. Severe hypoxia with asthma attack. Felt dizzy, fainting/no seizure disorder. Wheezing. Continue corticosteroids at high dosage for treatment.				Y	Y	3			Y	12/12/2002	12/12/2002	0	Theophberol 12/14 = 7.6  Bun/Su 12/12 and 10/1.1	OTH	OTH		Bronchial asthma	NKA; History of asthmatic bronchitis.			1						1	Dizziness; Dyspnoea; Hypoxia; Syncope; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0202616	05/06/2003	TX	61.0	61		F	04/12/2003	Client came to clinic on 01/29/2003-complaining pain in left upper arm.  Client states that after she received flu vaccine her arm hurt x1 week.  After 3 mnths the arm hurts to move up and down and backwards.  She can't disconnect bra without hurting.  No redness seen, no lung felt, no visible signs or distress.  Soreness in deltoid following flu vaccine 10/29/2002.  Copy of immunization record given to client along with Influenza VIS form.  See PMD for evaluation.  Will let clinic know outcome.  04/02/2003: Returned to clinic for some pain in left shoulder-has not improved-did not see PMD in 01/03.  No visible changes to arm-moderate to sever pain in left arm when she raises her arm or reaches toward back-pain at injection site when she does these things.  Continued pain in left arm after Influenza.  Will send a copy of this report to client.  Follow up evaluation by MD. 04/15/2003:  Client called to let nurse know she saw Dr. at left shoulder and uppoer arm pain.  He referred her to another Dr. who did x-rays and tests and determined she has bursitis of left shoulder and gave her injection in shoulder and medications.  She will return to him for follow-up.				Y						10/29/2002	11/05/2002	7	Patient reports was seen by Dr. and was told has Brusitis in left shoulder.	PUB	PUB	Glucotrol, Premarin	UNK	Diabetes			1						1	Hypokinesia; Injection site pain; Joint range of motion decreased; Pain; Shoulder pain	FLU3~SANOFI PASTEUR~U0925AA~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0202812	05/09/2003	KS	68.0	68		F	04/25/2003	Peripheral neuropathy documented by EMG with symptomatic onset 7-14 days after 2000 flu vaccine and worsened 7-14 days after 2002 flu and pneumococcal vaccine (1 wk after urinary infection)>. The 60 day follow up received on 8/11/03 states mild length-dependent primarily axonal peripheral neuropathy.								Y	N	11/01/2002			(+) EMG diagnosis of peripheral neuropathy	PVT	OTH	Unknown medication for urinary infection	Urinary infection	NONE			1						1	Neuropathy peripheral	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA	Disabling	Influenza
0202869	05/12/2003	WV	37.0	37		F		Pt was admitted to hospital on or about 01/04/2003 and was Dx'd with Guilliam Barre Syndrome on or about 01/06/2003 (Confirmed by spinal tap) Discharge summary states numbness. msv							Y		Y	11/04/2002	01/04/2003	61	Spinal Tap Discharge summary states CSF abnormal. msv	OTH	PVT	UNK	NONE	unk		wv0303	1						1	CSF test abnormal; Guillain-Barre syndrome; Hypoaesthesia; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U0966AA~4~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0202960	05/13/2003	TX	3.0	4		F		High pitched screaming, crying.  Very aggitated, unable to calm down.  Lasted for hours until late in evening.									U	10/23/2002	10/23/2002	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Crying	FLU3~SANOFI PASTEUR~U0428MA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0203060	05/14/2003	NV	18.0	18		M	05/07/2003	20 yo male unknown history transferred with AMS. Pt experienced a seizure in the field. Brought to ED with temp 102.3. Intubated. Seized during sedation with etomidate . Given Decadron and Dilantin. Admitted. Vented overnight.				Y	Y				U	03/18/2003	03/19/2003	1	Brain MRI nl, EEG wnl, Urinalysis negative	MIL	MIL						1						1	Convulsion; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~HEP A + HEP B (TWINRIX)~1|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~UNK~~~MENINGOCOCCAL (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0203066	05/14/2003	OH	47.0	47		M	12/27/2002	Hives (size of bug bites) on hands started about 1 week following vaccine and has exponentially spread over entire body. Denies any other symptoms of illness pre-post vaccine. Rx - Axid, Zyrtec D (both started 12/5), Prednisone (started 12/19).				Y					N	11/07/2002	11/14/2002	7	MD ordered blood test to rule out bacterial/viral infection.	PUB	PVT	Allegra	NONE	Seasonal allergies			1						1	Urticaria	FLU3~SANOFI PASTEUR~U0966BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0203067	05/14/2003	OH	69.0	69		M	02/18/2003	Pt's right upper arm became red, swollen and painful to move. Symptoms started AM after shots were given. Redness and swelling extended from shoulder to below elbow. Symptoms began improving 4 days after shot given.									Y	02/14/2003	02/15/2003	1		PUB	PUB	NONE	NONE	NONE			1						1	Injection site erythema; Injection site swelling; Pain; Erythema; Joint range of motion decreased; Oedema; Pain; Hypokinesia; Injection site erythema; Injection site oedema; Pain	FLU3~SANOFI PASTEUR~U0949AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0445M~2~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0445M~2~IM~~PNEUMO (PNEUMOVAX)~2|FLU3~SANOFI PASTEUR~U0949AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~0445M~2~IM~RA~PNEUMO (PNEUMOVAX)~3	USA		Influenza
0203088	05/14/2003	MS	31.0	31		F		Fine rash noted on back, abdomen and arms.									Y	10/17/2002	10/17/2002	0	NONE	PUB	OTH	UNK	NONE	NONE			1						1	Rash	FLU3~SANOFI PASTEUR~U0888AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0203155	05/14/2003	GA	43.0			M	05/14/2003	PERIORBITAL ANGIOEDEMA, HIVES, GENERALIZED URTICARIA.  REQUIRED HOSPITALIZATION.  TREATED WITH PREDNISONE, ALLEGRA 180 AND BENADRYL.  AS OF 9 APRIL 2003 (18 DAYS AFTER VACCINATION), PATIENT STILL HAS A PATCH OF ELEVATED ERYTHEMA.					Y				Y	03/22/2003	03/23/2003	1		MIL	MIL						1						1	Angioneurotic oedema; Erythema; Urticaria	ANTH~MICHIGAN DEPT PUB HLTH~~1~~~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~2~~~HEP B (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~1~~~MENINGOCOCCAL (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0203274	05/19/2003	TX	61.0	61		F		Severe allergic type respiratory condition. Weakness and fatigue.			Y						N	12/16/2002	12/16/2003	365		UNK	UNK	Albuterol, Maxaire, Astrovent		COPD epilepsy (past), asthma, bronchitis, emphysema			1						1	Asthenia; Fatigue; Hypersensitivity; Respiratory disorder	FLU3~EVANS VACCINES~U0874AA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1026M~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening	Influenza
0203565	05/23/2003	OH	74.0	74		F	05/19/2003	From initial information received on 5/16/03 from the patient's relative, regarding an adverse event, it was reported that a 74 year old female patient received FLUZONE SV 2002-2003, lot number U0930FA, given on 10/23/02. About one week later, the patient developed a sore throat and weakness in her legs, was seen by a health care professional. On 11/27/02, the patient was admitted to the hospital for three months and was diagnosed with GBS. Reportedly, it is unknown if the patient recovered. The patient had triple bypass surgery in 200 and has allergies to Penicillin and Protamine. The reporter will send additional information.  Follow up on 07/08/2003:.  Follow up on 01/21/04: No additional information is anticipated. Case is closed.					Y	99			U	10/23/2002	10/30/2002	7	From follow up information received on 06/24/2002:	PVT	OTH	Insulin, Potassium, Lasix, Zantac, Aspirin, Lanoxin, Synthroid, Altace,		2001 had Triple Bypass; Has allergies to Penicillin and Protamine		200300676	1						1	Asthenia; Guillain-Barre syndrome; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U0930FA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0203685	05/28/2003					M	05/21/2003	Information has been received regarding a case in litigation concerning a male who was vaccinated with a dose of hepatitis A virus vaccine inactivated. In 2001, the patient received the vaccination due to a work assignment outside the country. From November 2001 to January 2002, the patient became seriously ill. Medical tests determined that he had contracted hepatitis A and had suffered severe liver damage. At the time of the report, the patient continued to suffer symptoms of the disease and has been unable to work. The patient claimed the vaccine he received failed to protect him from the debilitating liver disease. It was reported that hepatitis A virus vaccine inactivated pre-filled syringes were recalled after 5/29/01. The patient was notified of the recall in December 2001; however the patient did not return from his work assignment until more than one month later. Upon internal review, hepatitis A and severe liver damage were considered to be other important medical events. Additional information has been requested.  Received on 06/03/2003: Follow up information indicated that the patient left the country on 11/03/2001 and returned to the country on 01/28/2002.  It was noted that the patient became very ill while he was away.  It was indicated that he began experiencing symptoms of hepatitis A in early December 2001.  He experienced fatigue, and had no appetite, frequently vomited after eating and his skin appeard slightly yellow.  The patient treated his symptoms with over the counter medications, believing that he was suffering from dysentery.  On 03/10/2002, the patient was again assigned to work outside of the country.  The patient continued to experience extreme illness while he was out of the country and sought medical attention once he returned home in May 2002.  Blood tests, urine tests, and chest x-rays were ordered, and the patient was diagnosed with hepatitis A and it was noted that his liver was severely damaged as a result.  It was noted that as a result of the vaccine's failure, the patient contracted hepatitis A and became ill in December 2001 and continues to experience symptoms presently, as of 05/20/2003.  Upon internal review, hepatitis A and severe liver damage were considered to be other important medical events. Additional information has been requested.  (OMIC) Follow up on 10/28/2003: Follow up information received from medical records indicated that the patient presented to the physician's office on 09/09/2002 with a history of general malaise, pains, fatigue, and some dark urine for approximately 10-11 months.  According to the patient, he out of the country in 12/2001 due to job related issues.  Prior to his travel, he was vaccinated with a dose of hepatitis A virus vaccine inactivated and also received malaria prophylaxis.  While out of the country, the patient started feeling sick and mostly his symptoms were described as some fevers, sweats, chills, dark urine, yellow stools, depression, generalized fatigue, not feeling well, and malaise.  The patient's symptoms have been persistent since then without any significant improvement.  Since the patient has returned to the country three to four months ago, he has been persistently short of breath with fatigue and cough.  He has some abdominal pains, diarrhea, yellow stool, dark urine and stiffness in his joints.  The patient had a significant work up done by his primary care physician including hepatitis B and C serolgies, which were negative.  It was noted that the patient was vaccinated with a first and second dose of hepatitis b vaccine (manufacturer unknown).  His hepatitis C antibody was negative.  Hepatitis A IgM was negative but IgG was positive.  The patient was found to have increased LFT's in 100 range, below 200 range, and also was found to have lymphocytosis on CBC.  His chest x-ray was negative.  There is no record of blood cultures drawn at that time.  The patient had a clarithromycin (Biaxin) tiral and he apparently did not resond.  Also, the patient had an ultrasound done in June of his right upper quadrant, which showed some fatty liver, otherwise no significant findings.  He had an EGD done and he also had a colonoscopy done.  All were negative.  His stool studies were negative for ova and parasites and his CD also was done.  The patient does not have any significant headaches, no visual changes, but has very generalized malaise.  He still had feelings of fevers, and some chills and sweats.  The patient has shortness of breath and persistent cough, mostly dry.  He has no sore throat. The patient has diffuse abdominal pain.  He has yellow stool and dark urine, stiffness in his joints, and tremors in his hands.  The patient also reported that he had PPD placed in the past, which was negative.  The physician indicated that the patient comes with long-standing symptoms of generalized fatigue, weakness, questionable fevers, and abnormal LFT's suggesting hepatitis.  The physician noted that he doubts that hepatitis virus is the cause of his symptoms.  He was negative for hepatitis B and C.  His IgG that was positive for hepatitis A was mostly due to prior vaccinations.  Also, hepatitis A is not usually the cause of such extensive persistent symptoms.  Other concerns included to rule out other hepatitis, especially hepatitis E, to rule out other herpes viruses such as CMV and Epstein-Barr virus, especially with a history of lymphocytosis.  The physician was also concerned about other causes of possible hepatitis such as possible autoimmune disease such as autoimmune hepatitis.  It was also mentioned that the LFTs were not significantly elevated, which is atypical for the disease.  Also, infection-wise, there is a possibility of brucellosis, which can affect the liver and cause a variety of syndromes, and TB needs to be considered.  The patient was negative for PPD in the past, and his chest x-ray was negative, but miliary TB can present like this.  The physician noted that the patient had been sick for 10 months so it would be unusual for TB to present like this.  Information was received which pertained to events which occurred after vaccination with hepatitis A virus vaccine inactivated.  This information contained the following adverse experiences: shortness of breath (approximately 09/09/2002); persistent cough, mostly dry (approximately 09/09/2002); stiffness in his joints (approximately 09/09/2003); tremors in his hands (approximately 09/09/2002); and depression (approximately 09/09/2002).  Upon internal review, hepatitis A, severe liver damage, and a positive Epstein-Barr virus IgG were considered to be other important medical events (OMIC).  Additional information has been requested.  All available medical records will be provided upon request. Follow up on 11/05/2003: Follow up information received on 10/22/2003 indicated that dose of hepatitis A virus vaccine inactivated that the patient received was recalled.  It was noted that the patient contracted hepatitis A due to the hepatitis A virus vaccine inactivated ineffectiveness which caused him severe pain and suffering.  In addition, the illness prevented him from working as he was unable to fulfill the usual and normal duties of his profession.  The patient also suffered from emotional distress due to the fear of the damage caused by the illness and the lasting effects on his health.  The combined physical, mental and emotional injuries caused by the failure of the vaccine to adequately provide the patient with protection from hepatitis A also resulted in depression which continued to preclude him from working.  Although the exact date is not know, the patient began to suffer from hepatitis A symptoms in approximately December 2001.  On 06/13/2002, the patient was tested for hepatitis A, and the results showed that the patient was positive for hepatitis A.  The patient has suffered, presently suffers, or will suffer pain and suffering due to the physical effects of hepatitis A, fear of future effects of the virus on his health, mental distress, mental anguish, inconvenience, and/or loss of capacity for the enjoyment of life.  The patient's last day working was 05/09/2002.  He was incapacitated from this date through April 2003.  The patient was hospitalized from 10/23/2003-10/26/2002 and from 12/11/2002-12/14/2002.  The patient has been prescribed two doses of hepatitis B vaccine (manufacturer unknown) which were administered on 06/21/2002 and 08/16/2002, clarithromycin (Biaxin) purchased on 07/16/2002 and 07/26/2002, polyethylene glycol 3350 (+) potassium chloride (+) sodium bicarbonate (+) sodium chloride (+) sodium sulfate (Colyte) purchased on 07/16/2002, pantoprazole sodium (Protonix) purchased on 07/23/2002, hyoscyamine purchased on 07/30/2002, sertraline hydrochloride (Zoloft) purchased on 07/30/2002, paroxetine hydrochloride (Paxil) purchased on 10/14/2002 and 11/21/2002 and 12/14/2002, zolpidem tartrate (Ambien) purchased on 11/21/2002, and mirtazapine (Remeron) purchased on 12/14/2002.  Upon internal review, hepatitis A, severe  liver damage, and a positive Epstein-Barr Virus IgG were considered to be other important medical events (OMIC).  Information was received which pertained to events which occurred after vaccination with hepatitis A virus vaccine inactivated.  This information contained the following adverse experiences: shortness of breath (approximately 09/09/2002); persistent cough, mostly dry (approximately 09/09/2002); stiffness in his joints (approximately 09/09/2002); tremors in his hands (approximately 09/09/2002); and depression (approximately 09/09/2002).  Additional information has been requested.  All available medical records will be provided upon request.									N		11/01/2001		Chest x-ray (5/??/2002); Diagnostic laboratory (05/??/2002); Urinalysis (05/??/2002); Abnormal laboratory data include: (06/13/2002: MCH was elevated at 33.9 PG, MPV waslow at 7.4 FL, HAV AB (total) was positive; on 07/02/2002: cholesterol was high at 214 H mg/dl, protein was high at 8.4 g/dl, AST and ALT were high at 178 u/l and 122 u/l.  On 06/17/2002, a chest x-ray showed prominent bronchovascular markings and prominent left hilum.  On 07/16/2002, an ultrasound of the gall bladder and biliary systems showed fatter liver otherwise essentially normal.  On 07/23/2002, a biopsy of the esophagus showed changes consistent with reflux esophagitis and the rectal biopsy showed benign submucosal gastrointestinal scromal tumor (leiomyoma).  On 09/09/2002, the Epstein-barr virus test IgM was negative at <0.91, the Epstein-barr virus test IgG was positive at 6.81.  On 09/19/2002, the hepatitis E virus IgG was non reactive.  On 10/16/2003, a CT of the abdomen showed diffusely fatty liver and cortical renal cysts otherwise normal with no evidence of cirrhosis or portal hypertension.	OTH	OTH	UNK		Smoker		WAES0305USA01615	1						1	Drug ineffective; Hepatitis A; Hepatocellular damage; Laboratory test abnormal	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~MERCK & CO. INC.~~UNK~~~HEP A (VAQTA)~1	USA		Influenza
0203849	05/28/2003	MI	4.0	4		F	05/14/2003	A nurse reported the occurrence of redness at the injection site in a 4-year-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt's medical history included environmental allergies. Other relevant medical history and concurrent conditions were not provided. Concurrent medications included loratadine (Claritin) and fluticasone nasal spray (Flonase). On 10/03/2002 the pt received his 4th injection of Infanrix. On that date, he also received injections of inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and influenza virus vaccine (manufacturer unknown). The nurse stated that immediately after receiving the injection, the pt developed slight redness at the injection site. By 10/06/2002 the injection site redness increased in size to about 10 in diameter with a white center. The nurse stated that the site had not been painful or feverish. The pt was treated with diphenhydramine with improvement. On 10/07/2002 the pt was seen by the pediatrician who noted that the injection site redness had decreased to about 5 in diameter and there was no hardness, tenderness or cellulitis. The physician recommended cold compresses and diphenhydramine as needed. The event had almost resolved on 10/07/2002.				Y					N	10/03/2002	10/06/2002	3		OTH	OTH					A0382677A	1						1	Injection site erythema	DTAP~GLAXOSMITHKLINE BIOLOGICALS~57A2~4~~~DTAP (INFANRIX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~SANOFI PASTEUR~T0234~UNK~~~POLIO VIRUS, INACT. (POLIOVAX)~1	USA	Emergency room visit	Influenza
0203933	05/29/2003	CO	60.0	60		F	05/21/2003	Within hrs., shot site was large, red/pink oval at 4 inches in diameter by 2 inches high.  Lasted 4 days.  In one week, upper arm (site of shot) muscle was throbbing in pain.  Pain so strong patient was unable to use arm for 2 1/2 months.  Now 6 months, after shot, patient occasionally has pain in that upper arm-minor pain. The follow up states, Dr's nurse said I just had a plain flu shot-not BCG type of shot.									Y	10/16/2002	10/16/2002	0	NONE	PVT	OTH	Lisinopril, Spironocactone, Warfarin	NONE	Codeine/Porosyn.  On Wartorin			1						1	Injection site pain; Rash erythematous	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0192331	06/03/2003	AZ	13.0	13		M	05/28/2003	Information has been received from a physician and a nurse concerning a 13 year old white male with a history of truncus arteriosus persistent who on 10/17/2002 was vaccinated with the first doese of hepatitis A virus vaccine inactivated given intramuscularly in the right arm (lot #643695/0989M).  Concomitant therapy, that same day, included the third dose of hepatitis B vaccine recombinant (yeast) given intramuscularly in the right arm (lot # 642483/0008M) and the seventh dose of influenza virus vaccine given intramuscularly in the left arm (lot # U0885AA).  On 10/19/2002 the patient developed hives and itching all over.  It was noted there were no laboratory tests performed and the patient did not have an illness at the time of vaccination.  The physician also provided information regarding other patients (WAES#0210USA02857 & 0210USA02798).  The reporter expressed a concern regarding the lot number.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  This lot complies with the standards of the Center for Biologics and Research and was released.  The patient required a visit to his physician.  No further information is available.				Y					U	10/17/2002	10/19/2002	2	NONE	PVT	PVT	UNK	UNK	Truncus arteriosus persistent		0211USA00109	1						2	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|HEP~MERCK & CO. INC.~0008M~3~IM~~HEP B (RECOMBIVAX HB)~2|HEPA~MERCK & CO. INC.~0689M~1~IM~~HEP A (VAQTA)~2	USA	Emergency room visit	Influenza
0204160	06/03/2003	NC	51.0	51		M	05/28/2003	05/27/2003 states after received shots, face tingled, eyes burned, and felt dizzy. States when got home tongue swelled and throat felt like it was swelling. States took a nap and it resolved. BP 05/27/2003 received at health dept and waited 20 mm   BP 124/70 and stated was felling better when left  no complaints today 05/28/2003									Y	05/27/2003	05/27/2003	0	NONE	PUB	PUB	Prozac, Blood pressure med, Blood sugar med		Type 2 DM, Hypertension, depression		NC03065	1						1	Dizziness; Eye irritation; Paraesthesia; Throat tightness; Tongue oedema	FLU3~SANOFI PASTEUR~U0925AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0675M~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U0528AA~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0193014	06/04/2003	OR	48.0	48		F	01/23/2003	Hives post-infection, diff. breathing, HA, malaise, stiff neck with ? decrease effectiveness of anti-epileptic drug- to do max; we are now increasing drug to see if can recapture control									U	10/23/2002	10/23/2002	0		PVT	PVT	Topamax 100mg/day; Aloactazine/ synthroid	NONE	Food allergies, those to certain meds seizure disroder, hypothyroidism			1						2	Dyspnoea; Headache; Malabsorption; Musculoskeletal stiffness; Urticaria	FLU3~SANOFI PASTEUR~U0920AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0204243	06/04/2003	NM	74.0	74		F	05/27/2003	L upper arm above elbow erythema with swelling. Tx-Keflex 500mg q 6 hr x 7 days, Benadryl 25mg q 6 hr x 3-5 days.				Y					Y	01/08/2003	01/08/2003	0		PVT	PVT						1						1	Erythema; Oedema	FLU3~SANOFI PASTEUR~V0940AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0873M~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0204514	06/05/2003	PA	53.0	53		F	05/20/2003	53 year old adm 12/2. 4 weeks ago, the patient given the flu vaccine (1st time) and developed a productive cough, myalgias, fevers (as high as 100), and a sore throat. Patient given azithro. Symptoms continued so patient we to ED. CXR (+); ? pneumonia. Patient given another course of azithro and felt better. Approximately 1.5 weeks PTA, patient noticed a pruritic area on the back of her right arm and right thigh. The lesions started to swell to approximately 1 cm in size. PMD increased her prednisone. Lesions became purple and patient diagnosed with new anemia. Patient awoke on 12/1 with painful LE lesions. Patient started on stress dose steroids. Morphine given for pain. ESR=76. Systemic vasculitis secondary to the influlenza vaccine suspected. Bx: c/w hemorrhagic skin necrosis. Most likely antiphospholipid precipitated by the flu vaccine.					Y				Y	11/01/2002	12/02/2002	31		UNK	UNK	Glipizide; Prednisone, Nizatidine; Monopril; Hydrocodone; MVI; Calcium Carbonate; B12; Vitamin C; Soylecithin; Netformin		NDA; NIDDM; Polymyositis; HTN; RA; Ventra Hernia; C-Section; Gum Surgery			1						1	Anaemia; Cough; Myalgia; Pain; Pharyngolaryngeal pain; Pruritus; Pyrexia; Skin necrosis; Skin ulcer; Vasculitis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0191862	06/10/2003	CA	44.0	44		F	06/05/2003	A registered nurse reported second hand that an adult female pt, had received Fluzone through company who give public flu shots. It was reported by the pt's husband that she had a seizure during the night just 4 days after receiving Fluzone. Their doctor could find nothing wrong. From additional info received on 4/14/03 from the pt, it was reported that the 44 year old received the Fluzone SV'2000-'2001 USP at 12:30PM on 11/14/01. She also reported that no tests found that the flu shot caused the onset of the seizure. She had another seizure after she stopped the medicine, three days after starting a lower dose of birth control pills. She went back on Depakote. She is still under a physician's case, a neurologist and still on Depakote. Reportedly, she has not had any seizures since the second incident occurred after taking Estrogen. Upon internal review, on 6/4/03, it was decided to upgrade this case to serious (OMIC) from non-serious based on medical judgment.				Y					Y	11/14/2001	11/18/2001	4	No tests found that the flu shot caused the onset of the seizure.	OTH	OTH	Motrin	NONE	Motrin once a month for cramps.		U200101235	1						2	Convulsion	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0204724	06/10/2003	TX	61.0	61		F	06/09/2003	None stated.									U	12/12/2002				OTH	OTH						1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U0874AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1026M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0204787	06/11/2003	TN	60.0	60		F	11/21/2002	A 60-year-old female reported that she received pneumococcal polyvalent (manufacturer unknown) and influenza virus (manufacturer unknown) vaccines on 10/04/2002.  The following day, she developed an injection site reaction characterized by swelling, redness, and soreness.  The patient also experienced chills, nausea, a headache, coughing, arm cramping, and sore throat.  She was seen in an emergency room where she was treated with an unspecified steroid and instructed to apply ice to the injection site area.  Approximately 1 week later, the patient was seen by her physician who prescribed a cough medicine.  Results of a chest x-ray found nothing clinically significant.  As of the date of this report, the reporter states that her arm is still tender and will cramp occasionally and that the nausea, sore throat, and cough have not resolved.  This is 1 of 2 patients from this facility who had an adverse experience following receipt of Pnu-Imune 23 vaccine.  See MCN HQ4898728OCT2002.				Y					U	10/04/2002	10/05/2002	1	X-ray NOS chest (LLT: X-ray NOS chest): nothing clinically significant	PVT	OTH	Diovan HCT, Synthroid	UNK	Hypertension NOS (LLT: Hypertension NOS)		HQ4900828OCT2002	1						1	Chills; Cough; Headache; Injection site erythema; Injection site oedema; Injection site pain; Muscle spasms; Nausea; Pharyngolaryngeal pain; Chills; Cough; Hyperhidrosis; Injection site oedema; Pain; Pharyngolaryngeal pain; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~~LA~PNEUMO (PNU-IMUNE)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0204871	06/13/2003	TX	76.0	75		F	04/22/2003	Guillain-Barr‚ syndrome. IVIG, plasma phresis. The 60 day follow up received on 9/3/03 states, still suffering with Guillain-Barre syndrome. Breathing difficulty continues. Can not walk due to weakness and arthritis problems. Has improved some, but at a very slow rate. Lot # for pneumonia vaccine is unknown-no record at Dr. office. 12/20/05 Reviewed medical records. Add accident with injuries.					Y	30	Y		N	11/19/2002	11/21/2002	2		PVT	PVT		NONE	Penicillin allergy; hypertension; hypercholesterolemia			1						1	Abasia; Arthritis; Asthenia; Dyspnoea; Guillain-Barre syndrome	FLU3~SANOFI PASTEUR~U0899AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~2~IM~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0204897	06/13/2003	IL	23.0	23		F	06/10/2003	A nurse reported the occurrence of a rash in a 23-year-old female who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) for prophylaxis. The pt's medical history included asthma and allergies to grass and dust. The pt had no adverse experiences following receipt of previous immunizations. Concurrent medications included albuterol as needed. On 01/29/2003 the pt received her first injection of Twinrix (lot HAB235A4). On that date, she also received an injection of influenza virus vaccine (manufacturer unknown). Four days post-immunization, on 02/02/2003, the pt developed an itchy rash on her abdomen and back. The rash and itching resolved after approximately one week. The Twinrix immunization series was delayed.									Y	01/29/2003	02/02/2003	4	UNK	OTH	OTH	Salbutamol sulphate		Asthma, dust allergy, grass allergy		A0399989A	1						1	Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~235A4~1~~RA~HEP A + HEP B (TWINRIX)~1	USA		Influenza
0202012	06/17/2003	RI	78.0	77		U		Flu vaccine and Pneumovax booster given 10/25/2002. During 03/07/2003 visit, patients reports fever initially and weakness in both legs that resolved completely over next 2 months. Patient chose not to communicate it to me at the time. Overall healthy treated for depression. (by myself-Zoloft) with good response. The follow up received on 7/1/03 states pt reported trouble during office visit 3/7/03. Please noticed she is treated for ? and ? feeling better ? at the time of vaccination, has a lot of ? to accept therapy for depression.									Y	10/25/2002			NONE	PVT	PVT	Capoten, Procacet, ASA, Zoloft	NONE	Codeine Allergy			1						2	Depression; Muscular weakness; Pyrexia; Depression; Muscular weakness; Pyrexia	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~~2~IM~~PNEUMO (PNEUMOVAX)~1|FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~~UNK~SC~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0205035	06/17/2003	MO	35.0	35		F	06/17/2003	Generalized body aches Dry mouth Frequent urination									U	06/11/2003	06/11/2003	0	None indicated	MIL	UNK		None	Neg			1						1	Dry mouth; Pain; Pollakiuria	FLU3~PFIZER\WYETH~U0956AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~235A4~UNK~IM~RA~HEP A + HEP B (TWINRIX)~1|TD~GLAXOSMITHKLINE BIOLOGICALS~u0828aa~UNK~IM~LA~TD ADSORBED (DITANRIX)~1|TYP~SANOFI PASTEUR~u1073~UNK~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0205267	06/20/2003	NY	61.0	61		F	06/20/2003	sore, aching arm which has continued to date. Referred for physical therapy due to shoulder impingement.  Began physical therapy in early June 2003 and continuing treatment.				Y						11/14/2002	11/15/2002	1		UNK	UNK						1						1	Joint range of motion decreased; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0205222	06/23/2003	NY	68.0	68		M		A 68 year old male received RSV vaccine or Placebo and Influenza Vaccine on 10/16/02 and 205 days later died on 5/9/03. Investigator was notified by patient's family that he died at home. Will speak to family in a couple of weeks. The Investigator assessed the event as unrelated to the study product. Follow up on 07/08/2003: A 68 year old male received RSV vaccine or Placebo and Influenza vaccine on 10/16/2002 and 205 days later died on May 9, 2003.  Investigator was notified by patient's family that he died at home.  Will speak to family in a couple weeks.  The investigator assessed the event as unrelated to the study product.  Follow up information received 07/01/2003.  Investigator spoke with family members regarding death.  Death certificate lists CHF as cause of death.  Subject went from a lengthy hospitalization to a nursing home where he died approximately 1 week later.  Prior hospitalization in File # 2003-00364.  The Investigator assessed the event as unrelated to the study product. HISTORY OF PRESENT ILLNESS:  The patient is a 68 year old white male well known to me who is being admitted to hospital for acute syncope with resultant facial contusions and left knee contusion.  The patient was seen by myself last week in the ofice for his usual followup and also had an episode of either slipping vs. syncope with resultant left facial contusion and left conjuctival hemorrhage.  He was back to his baseline status and saw doctor at hospital today who is his cardiologist.  He suggested placing him on a Holter monitor because of the facial ontusion and questionable syncopal episode.  The patient left the hospital.  Apparently, the patient became lightheaded and passed out.  He landed on his face and chest and does not recall any events thereafter until he was at the hospital.  He was complaning of chest discomfort which he felt was due to contusing his chest but was treated as if it was cardiac in origin with aspirin, Nitroglycerin paste and morphine.  He also was placed in a left knee immobilizer.  He underwent a CAT scan of his head which was normal.  Chest x-ray revealed questionable mild congestive heart failure.  His labs are notable for his usual chronic renal insufficiency, hypoatremia, hypoalemia and an elevated white count of 14,000.  It was determined that the patient needed to be further evaluated due to his complicated history as well as syncope and possible cardiac issues.  He has since been transferred to a other hospital where he is presently complaining left knee discomfort and mild palpable chest discomfort.  He is not short of breath and is frustrated with the overall situation.	Y	05/09/2003							N	10/16/2002	05/09/2003	205	BP: 109/59;  Pulse: 81;  Respirations 16;  Pulse oximetry: 95% on 3 liters;  alert and oriented x 3;  CT of head: negative for bleed or stroke;  ENG: Consistent with atrial flutter with irregular ventricular response ranging from 80-90;  Blood glucose: 224;  BUN and creatinine: 64/1.8;  Sodium: 131;  Potassium: 3.3;   Chloride: 84;  CO2: 37;  Alkaline Phosphatase: 341;  CK: 34;  LDH: 709;  Lipase: 301;  White count: 14;  Hematocrit: 39.7;  Platelets: 330,000;  Neutrophils: 8.5%;  Lymphs and 0.4% eosinophils;	UNK	UNK	K-Dur, Enteric coated aspirin, Zaroxolyn, Prevacid, Lasix, Atenolol, Allopurinol, 2 liters of oxygen, Lantus, Humalog, Quinine, Combivent,		Type 2 diabetes poorly controlled, Recent HB1C of 8.8; Congestive heart failure felt more to be diastolic with recent ejection fraction of 55% and chronic ascites; Coronary artery disease status post coronary artery bypass grafting; Chronic bilateral leural effusions status post decortication; History of gout; Chronic renal insufficiency, Baseline BUN and creatinine recently 72/2.1; Ventral hernia; Glaucoma; GERD, COPD, Right bundle branch block;		200301034	1						1	Laboratory test abnormal; Unevaluable event	FLU3~SANOFI PASTEUR~U0921DA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0205223	06/23/2003	NY	71.0	70		M		A 71 year old male received RSV Vaccine or Placebo and Influenza Vaccine on 10/14/02 and 243 days later died on 6/14/03. Patient obituary discovered in newspaper, the investigator will contact family in a couple of weeks. Signs/Symptoms/Diagnosis: No data at present time. The Investigator assessed the event as unrelated to the study product. Follow up on 07/08/2003: A 71 year old male received RSV vaccine or Placebo and Influenza vaccine on 10/14/2002 and 243 days later died on 06/14/2003.  Patient obituary discovered in newspaper, the investigator will contact family in a couple of weeks.  Signs/Symptoms/Diagnosis: No data at present time.  The investigator assessed the event as unrelated to the study product.  Follow up information received 07/01/2003.  Investigator spoke with family members, regarding death.  They stated that subject died in bed.  Family physician thought cause of death was heart attack.  Autopsy was performed.  Results of the autopsy are not known yet.  Diagnosis: MI?.  The investigator site assessed the event as unrelated to the study product.  Further information is expected.  Follow up on 02/09/04: Additional information received 02/02/04.  After multiple attempts, unable to obtain autopsy results.	Y	06/14/2003							N	10/14/2002	06/14/2003	243		UNK	UNK	Duoneb; Flovent; Combivent; Slow-Bid; Lanoxin; Tenormin; Prevacid; Zestril; Lasix; Aldactone; Coumadin; Allopurinol; Zithromax		COPD; CAD; CHF; Bypass x2; Hypertension; MI; Emphysema; Gout; Indigestion; Dysrhythmia; Respiratory Infection; Ischemic Heart Disease		200301033	1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0205224	06/23/2003	DC	78.0	76		M		A 78 year old male received RSV vaccine or Placebo and Influenza Vaccine on 10/12/02 and experienced congestive heart failure and was admitted to the hospital (unknown date). Patient was discharged on 3/7/03. Patient has a history of Chronic Ischemic Heart Disease and COPD. The Investigator assessed the event as unrelated to the study product. Follow up information received on 6/13/03: A request for patient's records has been requested from hospital. Other records requested from the primary physician. The information received from the patient's primary doctor did not include any information regarding his hospitalization. An attempt will be made to contact the patient for information. The investigator assessed the event as a possible relationship to the study product.  Follow up on 06/27/2003: Progress notes: 03/06/2003.  2nd Echo with Doppler 1) Technically difficult study. 2) NL LV site with mild conc. LVA, with NL overall LV function, est EF is 55%. 3) LA and RA enlargment 4) Dilated RV 5) Echo dense ascending aorta may reflux atherosclerotic plaque or calcium deposits. 6) Thickened aorta leafuts with mild AI, no AS by Doppler.  NP B Cardiology: 77 year old male with PMB of HTN, CAD - S/P CABG -99, A.Fib, NHL -'91, asthma type 2 DM.  Admitted 03/05/2003 with several day history of SOB and LE edema, + ocassional wheeze.  Pulmonary consult per doctor in ER.  Patient admitted for further evaluation.  S: I'm feeling better; O: 97.2 - 73-20  780/75 Tele. A. Fib; W: S1, S2 irregular/irregular;Weight 232.3lbs; Resp. -bilateral crackles; Abdomen: soft/nontender; Ext: 4 edema + distal pulses; Neurological: alert and oriented x 3.  A: #1 CHF - diuresing start Diovan - on Lasix. #2 Asthma - as per pulm. #3 NL LV function with EF = 55% per Echo 03/06/2003. #4 HTN - BP stable. #5 CAD - s/p CABG '99. #6 NHL - '91. #7 Lumbar pain - as per ortho.  2nd MLI of lumbar spin to lg. spinal stenosis.  Type 2 DM - on Prandin,  Diovan 80mg po qd; Decrease Norvasc to 5 mg po qh; K-Dur 40mg po x 1 for K + 3.6; MRI of lumbar spine; Continue med. prescription.  03/07/2003: Paitent discharged to home via wheelchair with all belongings.					Y					10/29/2002				UNK	UNK	Diovan; Norvasc; Atenolol; Advar; Singulair; Pranolin; Celexa;		Chronic Ischemic Heart disease; COPD		200300302	1						1	Cardiac failure congestive	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0205263	06/23/2003	IL	67.0	66		F	06/21/2003	Sore arm-swollen, red, hot									Y	10/25/2002	10/25/2002	0	She had no labs prior to shot (no hint of infection)	PVT	PVT	Vioxx 125mg OD, (had before hx)	NONE	Allergic codeine			1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~EVANS VACCINES~30432GA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1353L~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0198551	06/25/2003		19.0			M	06/20/2003	From initial information received on 6/12/03, it was reported that a 19 year old male patient received yellow fever, anthrax (dose one), typhoid, IPV, influenza, hepatitis A (dose one), Hepatitis B (dose two), MMR (dose two) and possibly varicella vaccinations (lot numbers, route, sites, and manufacturers not reported), administered 2/2/03. The patient also received a second anthrax vaccination on 2/20/03. Two days later, the patient was hospitalized with complaints of fever of 100.4F, sore throat, headache for five days, numbness from the knees down, weakness and difficulty walking. He also had pressure on genitalia and urge to urinate. The patient was diagnosed with acute disseminated encephalomyelitis and urinary retention. He was treated with high dose steroids and physical therapy. The patient was discharged to another hospital on 3/1/03. His condition regressed to inability to walk, decrease in sensation, inability to void after being off steroids for days. The patient did improve. He was put on oral steroids for three weeks. He was discharged from the hospital on 3/19/03 with discharge diagnosis of unspecified infectious and parasitic diseases, retention of urine, and post-infectious encephalitis. On 3/21/03, the patient stated that he still had some numbness in his feet, but is otherwise greatly improved. He also stated that he had been ill with an upper respiratory infection about mid-February and was taking amoxicillin, Sudafed, Motrin and Tylenol at the time of the anthrax vaccination on 2/20/03. Within one to two days afterwards, the symptoms of encephalomyelitis were noted and he was admitted to a local hospital until being transferred to a second hospital on 3/1/03.  Follow up on 12/19/03: From additional information received on 12/09/03 from the Yellow Fever vaccine meeting group it was reported that the pt had clinical, radiological and laboratory evidence of ADEM with IGM in CSF of 9.8.  This case was voted by the Yellow Fever Case Classification Group to be a probable yellow fever vaccine associated neurotropic disease with autoimmune involement.  No other information was provided.				Y	Y	18	Y		N	02/02/2003	02/22/2003	20	LP was done on 2/23/03. CSF results: glucose 77, protein 73, WBC count 159, RBC count 4, mononuc 90% (lymphs 78, monos 12). Lyme screen was negative. Blood and urine cultures had no growth. Throat culture was negative for strep group A. Testing was performed from two samples--a CSF sample and a serum sample, both collected on the 12th day of illness onset (03/06/03). The patient's illness onset day was 2/22/03. Results of the CSF: Good IgM response by MAC-ELISA; neutralization antibody assay not done for CSF; negative virus culture on Vero cells; TaqMan PCR for yellow fever was not done. Results of the Serum: Good IgM response by MAC-ELISA; plaque-reduction neutralization test to yellow fever virus was positive at a 1:320 titer; negative virus culture on Vero cells; negative TaqMan PCR for yellow fever.	OTH	OTH		The patient stated that he was ill with an upper respiratory infection in mid-February and was taking amoxicillin, Sudafed, Tylenol and Motrin at the time of the second dose of Anthrax on 2/20/03.	NONE		200301005	1						2	Asthenia; Dizziness; Encephalitis; Headache; Hypoaesthesia; Laboratory test abnormal; Neck pain; Pyrexia; Syncope; Urinary retention; Difficulty in walking; Encephalitis; Headache; Hypoaesthesia; Infection parasitic; Laboratory test abnormal; Micturition urgency; Pharyngolaryngeal pain; Pyrexia; Sensory disturbance; Urinary retention; Asthenia; Depressed level of consciousness; Difficulty in walking; Encephalitis; Headache; Hypoaesthesia; Laboratory test abnormal; Pharyngolaryngeal pain; Pyrexia; Urinary retention	ANTH~EMERGENT BIOSOLUTIONS~~2~IM~~ANTHRAX (BIOTHRAX)~1|ANTH~EMERGENT BIOSOLUTIONS~~1~~~ANTHRAX (BIOTHRAX)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEP~UNKNOWN MANUFACTURER~~2~~~HEP B (NO BRAND NAME)~2|HEPA~UNKNOWN MANUFACTURER~~1~~~HEP A (NO BRAND NAME)~2|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~2|MMR~UNKNOWN MANUFACTURER~~2~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~2|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~2|YF~UNKNOWN MANUFACTURER~~UNK~~~YELLOW FEVER (NO BRAND NAME)~2|ANTH~EMERGENT BIOSOLUTIONS~~1~~~ANTHRAX (BIOTHRAX)~3|HEP~MERCK & CO. INC.~~2~~~HEP B (RECOMBIVAX HB)~3|HEPA~MERCK & CO. INC.~~1~~~HEP A (VAQTA)~3|MMR~MERCK & CO. INC.~~2~~~MEASLES + MUMPS + RUBELLA (MMR II)~3|VARCEL~MERCK & CO. INC.~~UNK~~~VARICELLA (VARIVAX)~3|YF~UNKNOWN MANUFACTURER~~UNK~~~YELLOW FEVER (NO BRAND NAME)~3	USA	Hospitalisation	Influenza
0205507	06/26/2003	CO	39.0	39		F		Within 10 minutes of receiving flu vaccine, pt reported itching and redness at injection site. Redness 3 diameter around injection site. No systemic symptoms reported at that time. After cool pack applied, she stood up and unsteadily walked towards me, looking highly anxious. She stated I feel terrible and I'm going to faint after being assisted to lie down, she stated she had difficulty breathing 3 times. Stated I cannot feel my arms. BP not heard on left arm. Continued to tell us she had a hard time breathing. Never lost consciousness. Tx: Cool gel pack to injection site. Close observation. Assisted to floor in safe manner. BP attempted without success. 911 called as she was going down. Epinephrine .4cc subcu. of 1:1000 solution given in right arm. She stated I can breathe easier now about <1 minute after epinephrine injection - right deltoid. BP 110/88 right arm. Pulse, respirations attempted as paramedics arrived. (O2 by nasal canula, heart monitor, BP 110/58. revealed PVC's and HR = 46. Tx by emergency personnel) Transported to hospital at 9:45 AM.										11/05/2002	11/05/2002	0		PUB	OTH						1						1	Dizziness; Dyspnoea; Injection site erythema; Pruritus	FLU3~EVANS VACCINES~E31172GA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0205508	06/26/2003	CO	22.0	22		F		Initially, she felt weak and warm. She complained of headache, tingling of fingers, burning up. Then she broke out in reddened blotches on neck, chest and face. No difficult swallowing or respiratory distress noted. Did not lose consciousness, but eyes were rolling to top. Tx: Placed pt in Trendeleburg position after initial vital signs then vital signs repeated several times, as nurse continued to question and reassure pt until EMT's arrived. They took over from there. (Pt's mother works there too, so she was present throughout the incident). Pt called at home on 11/7/02. She said she developed a rash on her back that day and received Benadryl and MD suggested she have an allergy test done before a follow-up appointment.										11/04/2002	11/04/2002	0		UNK	UNK						1						1	Asthenia; Eye movement disorder; Feeling hot; Headache; Paraesthesia; Rash; Rash macular	FLU3~EVANS VACCINES~E31172GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0205552	06/26/2003	KS	41.0	41		F	06/26/2003	Patient admitted for cc of progressive weakness and numbness for 1 week prior to admission.  She had hx of scleroderma, Raynaud's phenomenon, glaucoma, pulmonary fibrosis, hypothyroidism, and had received the influenza vaccine 2-3 weeks prior to admission.  Along with hx of progressive weakness and numbness, pt showed elevated protein in CSF consistent with Guillain-Barre Syndrome  Pt was treated with 5 days of intravenous immune globulin in addition to supportive care.  Her weakness slowly resolved with IVIG therapy and she was discharged to rehab hospital. Infoiration received from discharge summary states vision change. msv			Y		Y	8			Y	10/26/2002	11/03/2002	8	11/11 CSF showed 15.6 protein Information from Discharge summary states elevated WBC. msv	UNK	UNK	Reglan, neurontin, synthroid, nexium, amitritpyline, ranitidine, bextra, diltiazem, diovan, prednisone, pulmicort.	None noted	scleroderma, raynaud's syndrome, pulmonary fibrosis, glaucoma, hypothyroidism, Raynauds phenomenon			1						1	Asthenia; CSF test abnormal; Guillain-Barre syndrome; Hypoaesthesia; Leukocytosis; Visual disturbance	FLU3~SANOFI PASTEUR~U0903AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0205555	06/26/2003	CA	48.0	48		M	06/26/2003	12/18/1998 Influencia Vaccination given at Kaiser 12/26/1998 Hospitalized at Kaiser Hospital with severe case of Guillain-Barre Syndrome (GBS).  I was given plasmapheresis (blood exchange) treatment at Kaiser Hospital.  Recovery took over 2 years.  Physical recovery after 2 years was about 90% of before GBS disease. The 60 day follow up received on 9/3/03 states after 2 years, pt was 90% recovered. Residual symptoms that remained were partial paralysis of face, toes and finger not working right, nerve damage, speech problems.   Nurse follow up on 08/31/04 states: Headache, pain lower extremities, urinary retention,			Y	Y	Y	19		Y	Y	12/18/1998	12/24/1998	6	Spinal tap test and blood tests were done. CSF abnormal;	PUB	PVT	None	Sinusitis, Bronchitis	Perennial Allergic Rhinitis; Anxiety; Depression; Hypertension; irritable bowel; degenerative joint disease; allergy;			1						1	Facial palsy; Guillain-Barre syndrome; Headache; Nerve injury; Pain; Speech disorder; Urinary retention	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0205575	06/30/2003	DC	75.0	75		M		A 75 year old male patient received RSV Vaccine or Placebo and Influenza Vaccine on an unspecified date. The patient was admitted to the hospital on 3/10/03 for pneumonia (both lungs). The investigator assessed the event as possibly related to study product. Follow up information received on 4/3/03: The patient was put on antibiotic therapy and there is a good chance he will be going to a rehab center when he is discharged. Diagnosis: Pneumonia in both lungs. Follow up information received 6/20/03: Investigator spoke to family members who refused to provide any information on patient. Plan to request records from hospital.					Y				U	10/03/2002	03/10/2003	158		UNK	UNK	Advair; Prednisone, Combivent; Verapamil		Emphysema; Palpitations		200300046	1						1	Pneumonia	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0205576	06/30/2003	CT	68.0	68		F		A 69 year old female received RSV Vaccine or Placebo and Influenza Vaccine on 10/10/03 and 205 days later on 5/21/03 developed acute Pancreatitis and was admitted to the hospital on 5/21/03. Patient experienced increasing abdominal pain and back pain, and was treated with Nexium, oxycontin and Colace. Discharged 5/25/03. Outcome: Recovered with residual effects (residual pain). The investigator assessed the event as possibly related to the study product. Follow up information received on 6/12/03: Patient was admitted to hospital 5/21/03 with severe epigastric pain, which was intermittent for several weeks. Given IV fluids and pain medications. During hospital stay patient had a MRI and ERCP performed. Hospital Course: The patient is a 68 year old white female with a significant past medical history for COPD and status post cholecystectomy who arrived from her primary care physician's office with abnormal pancreatic enzyme on the day of admission. She had been having severe epigastric pain off and on for the previous several weeks. The patient had been previously treated with nexium for this epigastric pain, however the pain continued effectively ruling out GERD. On the day of admission the pain was noted to be 10:10 in intensity. It worsened after a fatty meal. The patient had denied any nausea, vomiting, changes in stools, no melena, no blood per rectum, and no changes in skin color. However, she did have this worsening epigastric pain and some peritoneal signs. The patient was admitted on the evening of the 21st, was evaluated by myself on the morning of the 22nd. She was noted to have nausea, but no vomiting. No chest pain or shortness of breath. No diarrhea or constipation. Labs revealed a picture consistent with acute pancreatitis. The patient was made n.p.o treated with IV fluids, electrolytes were monitored and she was given pain management with morphine. Her triglyceride level was checked, which was normal. She was unable to be assessed by ultrasound on admission secondary to her obesity. CT was unable to be performed secondary to her severe contrast allergy. She received a MRI and ERCP. On the 22nd in the afternoon the patient underwent an ERCP performed by the doctor. THe procedure was performed without complication or difficulty. Multiple sweeps of iliac duct were performed finding a dilatation of the duct and distal duct debris. The patient was treated with prophylactic antibiotic of Zosyn prior to the procedure. The patient was changed to clear liquids in the evening of the 23rd. Her enzymes drifed down. Continually, the patient did not have a white count, was afebrile and tolerated her PO intake well. On the morning of the 25th the patient was reporting a completely resolved picture with only mild epigastric tenderness to deep palpitation. She had no more pain episode and felt to be in better health at this time. Review of her labs on the 24th showed continued drift downwards in all of the pancreatic enzymes. The patient was afebrile without a white count. Physical exam was noted only for a very mild tenderness in her epigastrium. She was tolerating her diet well and is to be discharged home on a low-fat diet. In discussion with the doctor and myself, the patient is in agreement with her discharge. This was discussed with doctor covering for doctor.					Y	4			Y	10/28/2002	05/21/2003	205		UNK	UNK	Aerobid; Nexium; Percocet; Colace; Senokot		Gall bladder; Allergy: IV Contrast Dye; COPD		200300826	1						1	Abdominal pain; Back pain; Dyspepsia; Nausea; Pancreatitis acute	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0205637	07/01/2003		42.0			M	12/05/2001	42 year old female health care worker (physician) who experienced onset of severe unremitting generalized headache, severe head-to-toe myalgias and profound malaise with onset 24-28 hours after influenza vaccine. The pt has no medical history of note. Headache was not positional, no hypersensitivity to light, no N/V/ocular abril. No relief with Tylenol, Motrin or sleep. Onset head-toe severe myalgia - no muscles spared. Muscles not painful to touch. No dark urine or change in stool color. Pt reports even toes hurt him. Profound malaise - no stamina or endurance. The pt has run a marathon and the severity of malaise exceeded the weakness after marathon. Denies fever, cough, coryza, URTI, diarrhea. Triad of headache, myalgias and fatigue lasted approx 2 weeks.										11/16/2000	11/17/2000	1		UNK	UNK	Beconate, Triamcinolone inhaler					1						1	Fatigue; Headache; Malaise; Myalgia	FLUX~UNKNOWN MANUFACTURER~4008173~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0198551	07/02/2003		19.0			M	06/27/2003	Information has been received from an agency concerning a 19 year old male who on 2/2/03 was vaccinated with a second dose of MMR (second generation). Concomitant therapy on 2/2/03 included a first dose of anthrax vaccine (manufacturer unknown), a dose of yellow fever virus vaccine live (manufacturer unknown), a dose of poliovirus vaccine (manufacturer unknown), a dose of typhoid vaccine (manufacturer unknown), a dose of influenza virus vaccine (manufacturer unknown), possibly a dose of varicella virus vaccine live, a first dose of hepatitis A vaccine (inactive) (manufacturer unknown) and a second dose of hepatitis B virus vaccine (manufacturer unknown) (there was no lot #'s provided for any vaccine). ON 2/20/03, the patient received a second dose of anthrax vaccine (manufacturer unknown). On 2/22/03, it was reported that the patient was hospitalized with complaints of fever 100.4 degrees F, sore throat, headache for five days, numbness from the knees down, weakness and difficulty walking. He also had pressure on genitalia and urge to urinate. The patient was diagnosed with acute disseminated encephalomyelitis and urinary retention. The patient was treated with high dose steroids and physical therapy. The patient was discharged to another hospital on 3/1/03. It was reported that his condition regressed to an inability to walk, decrease in sensation, inability to void after being off steroid for about three to five days. He was given another course of high dose steroids for five days and IVIG for two days. The patient did improve. He was put on oral steroids for three weeks. He was discharged from the hospital on 3/19/03 with a discharge diagnosis of unspecified infectious and parasitic diseases, retention of urine and post-infectious encephalitis. It was reported that on 3/21/03, the patient stated that he still had some numbness in his feet but was otherwise greatly improved. The patient stated that he had been ill will an upper respiratory infection about mid-February and was taking amoxicillin, pseudoephedrine hydrochloride, ibuprofen, and acetaminophen at the time of the anthrax vaccination on 2/20/03. The reporter indicated that within one to two days afterwards, the symptoms of encephalitis were noted. Lab testing included a lumbar puncture (LP) done 2/23/03. The CSF results were as follows: glucose 77, protein 73, WBC 159, RBC 4, mononuc 90%, lymphs 78, monos 12. The lyme screen was negative and the blood and urine cultures showed no growth. The throat culture was negative for strep group A. Testing was performed from two samples, a CSF sample and a serum sample, both collected on the 12th day of illness onset (3/6/03). Results of the CSF included: Good IgM response by MAC-ELISA (OD ratio 9.8), negative for West Nile, St. Louis and Powassan; neutralization antibody assay not done for CSF (there is no standard for this); negative virus culture on Vero cells and TagMan PCR for yellow fever was not done. Results of the serum included: Good IgM response by MAC-ELIZA (OD ratio 9.8), negative for West Nile, St. Louis Powassan; plaque reduction neutralization test for yellow fever virus was positive at a 1:320 titer; negative virus culture on Vero cells and negative TagMan for yellow fever. Additional information has been requested.				Y	Y	18	Y		N	02/02/2003	02/22/2003	20	Lab testing included a lumbar puncture (LP) done 2/23/03. The CSF results were as follows: glucose 77, protein 73, WBC 159, RBC 4, mononuc 90%, lymphs 78, monos 12. The lyme screen was negative and the blood and urine cultures showed no growth. The throat culture was negative for strep group A. Testing was performed from two samples, a CSF sample and a serum sample, both collected on the 12th day of illness onset (3/6/03). Results of the CSF included: Good IgM response by MAC-ELISA (OD ratio 9.8), negative for West Nile, St. Louis and Powassan; neutralization antibody assay not done for CSF (there is no standard for this); negative virus culture on Vero cells and TagMan PCR for yellow fever was not done. Results of the serum included: Good IgM response by MAC-ELIZA (OD ratio 9.8), negative for West Nile, St. Louis Powassan; plaque reduction neutralization test for yellow fever virus was positive at a 1:320 titer; negative virus culture on Vero cells and negative TagMan for yellow fever.	OTH	OTH		Upper respiratory tract infection	NONE		WAES0306USA02828	1						3	Asthenia; Dizziness; Encephalitis; Headache; Hypoaesthesia; Laboratory test abnormal; Neck pain; Pyrexia; Syncope; Urinary retention; Difficulty in walking; Encephalitis; Headache; Hypoaesthesia; Infection parasitic; Laboratory test abnormal; Micturition urgency; Pharyngolaryngeal pain; Pyrexia; Sensory disturbance; Urinary retention; Asthenia; Depressed level of consciousness; Difficulty in walking; Encephalitis; Headache; Hypoaesthesia; Laboratory test abnormal; Pharyngolaryngeal pain; Pyrexia; Urinary retention	ANTH~EMERGENT BIOSOLUTIONS~~2~IM~~ANTHRAX (BIOTHRAX)~1|ANTH~EMERGENT BIOSOLUTIONS~~1~~~ANTHRAX (BIOTHRAX)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEP~UNKNOWN MANUFACTURER~~2~~~HEP B (NO BRAND NAME)~2|HEPA~UNKNOWN MANUFACTURER~~1~~~HEP A (NO BRAND NAME)~2|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~2|MMR~UNKNOWN MANUFACTURER~~2~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~2|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~2|YF~UNKNOWN MANUFACTURER~~UNK~~~YELLOW FEVER (NO BRAND NAME)~2|ANTH~EMERGENT BIOSOLUTIONS~~1~~~ANTHRAX (BIOTHRAX)~3|HEP~MERCK & CO. INC.~~2~~~HEP B (RECOMBIVAX HB)~3|HEPA~MERCK & CO. INC.~~1~~~HEP A (VAQTA)~3|MMR~MERCK & CO. INC.~~2~~~MEASLES + MUMPS + RUBELLA (MMR II)~3|VARCEL~MERCK & CO. INC.~~UNK~~~VARICELLA (VARIVAX)~3|YF~UNKNOWN MANUFACTURER~~UNK~~~YELLOW FEVER (NO BRAND NAME)~3	USA	Hospitalisation	Influenza
0205802	07/03/2003	GA	46.0	45		M	06/27/2003	Received 4 vaccines on 01/25/2003 and developed flare in pemphigus vulgaris.  See attached summary.  Patient first developed blistering facial lesions in 06/2002.  Patient assumed it was sunburn and sought no medical care.  Over the next 2 months, patient developed blistering lesions over back, chest, shoulders and scalp.  This prompted evaluation by MD where the diagnosis of pemphigus vulgaris was made after 3 biopsies.  Patient was treated with prednisone 20 mg qd and the lesions reportedly calmed down, but did not resolve.  On 01/31/2003, patient had developed pustules, crusting, bleeding and erosions on the scalp, face, back and chest.  Patient's pain was rated at a 7/10.  The prednisone was continued and temovate ointment prescribed.  At a follow up appointment 3 weeks later, patient was noted to have improved with no new lesions.  The prednisone was decreased to 10mg qod, temovate cream continued and keflex 500mg bid x 10 days was added.  On the next 3 subsequent visits patient was treated with another course of keflex and/or bactroban ointment.  Ketoconazole shampoo was added and the prednisone dose changed to 5mg qd.  Patient's has pain from the erosive lesions most of the time.  Presently, patient reports 20 or more lesions on chest, back and arms.  Patient cannot lay on back without discomfort.  Patient's activities have been curtailed due to disfiguring lesions particularly on face.  Patient believes other shy away from him and that they believe patient has a communicable disease such as AIDS.									N	01/25/2003	01/28/2003	3	NONE, Previous positive biopsy for prephigus vulgaes.	MIL	MIL	Prednisone 10-20mg	Scattered lesions from PV	Pemophigus vulgaris, Hypertension, Onychomyosis, Hypercholesterolemia (untreated), Left ACL repair 2001			1						1	Pain; Skin ulcer	ANTH~EMERGENT BIOSOLUTIONS~FAV070~1~SC~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~UNK~~~MENINGOCOCCAL (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0205849	07/07/2003	NJ	1.0	0	.9	M	09/07/2002	Pt had negative reactions to previous vaccines, but the reaction to the MMR was immediate and severe. He experienced chronic (daily) vomiting, diarrhea, and gastrointestinal distress. The gastrointestinal problems continue and are unresolved other than vomiting.									N	10/11/1999	10/17/1999	6	Many - allergy, asthma, milk scan, blood, stool, digestion. Results indicate poor digestional health and immune system dysregulation.	PVT	PVT		Recent fever, respiratory infection	Allergies, eczema, asthma	immune system decline~DTaP (no brand name)~1~0.00~In Patient		1						1	Diarrhoea; Gastrointestinal disorder; Vomiting	FLU3~SANOFI PASTEUR~V0136AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0554J~1~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0206019	07/10/2003					U	07/08/2003	A psychologist reported that one of his parents received an injection of Flu Shield (2001-2002 formula) in 2001. Approximately 10 days post-immunization, the patient became very ill. The reporter stated that his patient lost nerves in the left leg and has lost complete use of the left leg. The reporter indicated that his patient has recovered to some degree. The reporter declined to provide additional information. This event was considered medically important (OMIC).									U				UNK	OTH	OTH	UNK	UNK	UNK		HQWYE842203JUL03	1						1	Lower motor neurone lesion; Nerve injury	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0193610	07/11/2003	CO	64.0	64		M	07/07/2003	Several days after flu shot, experienced severe abdominal pain, diarrhea, extended abdomen.  After 3 days of progressively worse symptoms changed into emergency room.  Had abdominal surgery.  Spent 8 days in hospital.  Had intestinal blockage.				Y	Y	8			U	10/31/2002	11/03/2003	368	NONE	PUB	PVT	NONE	NONE	NONE			1						2	Abdominal discomfort; Abdominal pain; Diarrhoea	FLU3~SANOFI PASTEUR~APU0919AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0206182	07/15/2003		80.0	79		F		A 80 year old female received RSV vaccine or Placebo and Influenza vaccine on 9/28/02 and 171 days later died on 3/18/03 of respiratory failure secondary to COPD. Death certificate states immediate cause was respiratory failure due to or a consequence of chronic obstructive lung disease due to or as a consequence of tobacco. The investigator assessed the events as unrelated to study products. On 10/17/02 the pt had been hospitalized with pneumonia, treated with Biaxin 10/29/02 to 11/2/02, Suprex 10/29/02 to 11/2/02 and Medrol Dose Pack 10/29/02. The pt recovered 10/29/02 (the date of discharge). The investigator assessed the events as unrelated to the study products. On 12/2/02 the pt was hospitalized for signs and symptoms of CHF and COPD. The pt was discharged on 12/5/02 and the condition was on going. On 12/9/02 the pt was hospitalized for COPD/AECB/bilateral pedal edema and CHF. A chest x-ray was done which showed pulmonary edema. The pt was discharged on 12/11/02 and the condition was on going. Follow-up info received 3/25/03. Discharge summary received for 12/2/02 to 12/5/02. Admission diagnosis date: chronic obstructive pulmonary disease, emphysema exacerbation, congestive heart failure. Discharge diagnosis date 12/5/02: 1. Chronic obstructive pulmonary disease exacerbation, emphysema. 2. Congestive heart failure with hypersensitive episodes. 3. Intermittent claudication. Diagnostic studies: Chest x-ray which shows marking consistent with chronic obstructive pulmonary disease and mild cardiomegaly. White blood count elevated throughout hospital stay secondary to high dose steroid use. This is a 79 year old female with long standing chronic obstructive pulmonary disease that has been having shortness of breath for a couple of days. She has a history of pacemaker and congestive heart failure. The pt was started on high dose Solu-Medrol and also Lasix diuresis and given Rocephin and Azithromycin in the hospital stay. The pt's symptoms improved each day with her breathing better and her pitting edema subsequently also diminished. Condition on discharge: The pt is stable and breathing much improved with no more chest tightness. The pt is stable for discharge. Discharge medications: Azithromycin 250mg po qd x 5 days and tapering Prednisone 20mg bid x 3 days and then qd x 3 days. The pt is to continue home medicines. The pt is to follow up with doctor in 5 to 7 days and encourage to ambulate at home and also use her incentive spirometry. Manufacturer number 2003-00031 was previously reported as number 2003-03-1109. Additional info received 7/8/03. Correction on administration date of vaccine to 9/28/02 for cases crossed referenced with this SAE, Linked cases for this pt-SAE 2002-10-10793, 2002-12-0874, 2002-12-0875	Y	03/18/2003							N	09/28/2002	03/18/2003	171	Chest x-ray which shows marking consistent with chronic obstructive pulmonary disease and mild cardiomegaly. White blood count elevated throughout hospital stay secondary to high dose steroid use.	UNK	UNK	Pletal; Acron; Allergan D; Ambien; Oxygen; Albuterol; Prednisone; Pulmicort; Biaxin; Suprex, Medrol Dose pack; Lasix; Accupril; Rocephin; Azithromycin; Solumedrol; Trental; Flovent; Celexa; Xopenex; humabid LA; Plavix; Lrazepam; K-Dur; Atro		Emphysema (diagnosed 2000), chronic bronchitis (diagnosed 1980), COPD (diagnosed 2000), allergies (diagnosed 2000-allergies to sulfa, iodine, oxycontin, oxycodone), HTN (diagnosed 2000), dizziness (diagnosed 2002), ASHD (diagnosed 2000), circulatory insufficiency (diagnosed 2002), depression/anxiety (diagnosed 2002), insomnia (diagnosed 2002), cataract L eye (diagnosed 2002), spinal stenosis. Pt had a right breast masectomy for Ca in 1992, cataract in R eye removed in 2002, pacemaker in 1990, carotid endart. Rt in 1993, TIA 9remote) in 1994.		200300031	1						1	Cardiomegaly; Condition aggravated; Dyspnoea; Emphysema; Intermittent claudication; Laboratory test abnormal; Oedema; Pneumonia; Pulmonary congestion; Respiratory failure; White blood cell count increased	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0206292	07/16/2003	UT	33.0	33		F	07/08/2003	Left shoulder bursitis 2 hours vaccine administered too high in arm.									Y	11/22/2002	11/22/2002	0	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Bursitis	FLU3~SANOFI PASTEUR~U0932AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0206325	07/17/2003	PA	98.0	98		F		A 98 year old female received RSV vaccine or Placebo and Influenza Vaccine on 11/4/02 and 212 days later died. Records have been requested and will send follow-up when more information received. The Investigator assessed the event as unrelated to the study product. Follow up information received 7/11/02. Subject expired 5/6/03 at nurse home. Diagnosis: Respiratory failure, chronic obstructive pulmonary disease, congestive heart failure, myocardial infarction, pneumonia, acute coronary syndrome, esophageal stricture. Follow up on 08/22/2003: Hospice Services RN Admission Assessment 05/06/03: DNR signed: Yes; Terminal Diagnosis: ES, CHF; Other Diagnosis: Acute Coronary Syndrome, Esophageal Stricture, Dyspnea, COPD; Radiation TX: None; Functional Limitations: Bowel/Bladder Incontinence, Ambulation, Speech; Activities permitted: Total bedrest; Mental Status: Unresponsive; Physical Assessment: Skin: Cool, Dry, Skin tugor: fair; Wound Care Record: Cleanse skin tear to R arm with NSS, apply triple antibiotic ointment, cover with dry dressing BID, D/C when healed; Sensor: hearing unknown, speech: nonverbal; Cardiovascular: Pulse-weak, Pedal Pulse-absent left and right.  Fingers and feet cyanotic; Respiration: shallow at rest, cough: non, non-smoker; Lung sounds: diminished, crackles.  Oxygen 4 L/min; Nutrition/Hydration: No intake; Gastrointestinal: Abdomen soft.  Bowel sounds: x4 Quadrants, Hypoactive, Bowel incontinence; Genito-urinary: Urine amber, clear, indwelling catheter; Abuse screen: no suspected abuse/neglect; Pain assessment: no indication of pain; Additional Assessment: no labwork scheduled; Activities of Daily Living: unable to ambulate, transfer, dressing, eating, toileting, bathing; Psycho social status: Caregiver understands illness is terminal: Yes; Care Needs: Symptom management; Caregiver's emotional response to current health status: continue with plan for symptom managment; Spiritual issues: last rights given 05/06/2003.  Interval History and Physican Exam: 06/01/2003.  History of Present Illness: 98 year old female treated for Resp. Failure, and DJD and now here for further managment.  Past Medical History: CHF, DJD, Pneumonia, Dysphagia, Dementia; We are unable to obtain a death certificate for subject.  Our site has made several phone calls to the son of the deceased subject referenced above and have received no response to our calls for a death certificate.  We have no other contact person and we are not aware that an autopsy was performed.  The only information that we have was received from the Health Center and was faxed to you on 07/11/2003.  The note written by the Dr. states that the subject expired in this facility on 05/06/2003.  You should already have this for your file.  If you need us to fax it again, please let us know.	Y	05/06/2003							N	11/04/2002			Physical Exam: Temp: 97.6, Pulse 72, R 24, BP 112/78; HEENT: Pupils reacting to light.  Resident is free of communicable disease including active Tuberculosis: Yes.	UNK	UNK	Albuteral; Lasix; Klor-Con; Tylenol PM; Roxanol; Levsin; Ativan		Coronary Artery Disease; Triple Coronary Bypass; Unstable Angina; Myocardial Infarction; Congestive Heart Failure; Acute Coronary Syndrome; Esophageal Stricture; Dyspnea; COPD; DJD; Pneumonia; Dysphagia; Dementia		200300899	1						1	Cardiac failure congestive; Coronary artery disease; Lung disorder; Myocardial infarction; Oesophageal disorder; Pneumonia; Respiratory failure	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0206530	07/23/2003	FL				M	11/05/2002	A male consumer reported that he received an injection of Flu Shield (influenza virus vaccine, trivalent, types A & B) (1996-1997 formula) (manufacturer unknown) in November 1996.  48 hours post-immunization, he developed a rash on numerous parts of his body.  The patient's physician prescribed a three week tapering dose of prednisone.  The patient indicated that he developes the rash five times a year and is treated with prednisone.  No further information was availabe at the date of this report.									U	11/01/1996	11/01/1996	0	UNK	OTH	OTH	UNK	UNK	UNK		4919429OCT2002	1						1	Rash	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0206531	07/23/2003					F	06/05/2003	Follow up information received on 05/09/2003 from the physician previously reported as the vaccine provider indicated that the patient did not receive a flu vaccine from this facility.  A medical assistant reported that a 67 year old female received a flu vaccine (manufacturer unknown) earlier this year and experienced nausea and vomiting post-vaccination.									U				UNK	OTH	OTH	UNK	UNK	UNK		756918APR03	1						1	Nausea; Vomiting	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0206590	07/24/2003	NV	38.0	37		M	07/21/2003	Transverse myelitis with progressive paraplegia. Pt developed numbness in left 4th and 5th toes 1-2 weeks after receiving the influenza vaccine in Nov 02. The numbness radiated down the lateral side of the left foot and the pt thought it was due to his boots. Within a few days he had similar symptoms in the right foot. The numbness progressed to the ankles in Dec 02, and then to the calves and by Jan 03 he experienced numbness from the knees down to the toes bilaterally. He had no associated pain, no tingling. He was able to walk but no longer able to run. He was in the process of changing duty, which delayed his seeking medical care. In March 03 he went to ER after the numbness progressed to the waist and he was occasionally losing his balance. He was seen by a PA and treated for gout. He followed up with the PA without improvement and was given a stronger medicine for gout. By the end of March he was seen in neurology and underwent outpatient testing but he did not receive the results. In mid-Apr 03 he awakened one morning and my knees gave out from under me and he fell to the floor. He was taken to the ER and was admitted to hospital for 2 weeks. He was diagnosed with Guillain-Barr‚ syndrome and received IVIG on 4/18/03. He reports that he initially re-gained movement of the knees but that the improvement didn't last.  However, when he was transferred to rehabilitation hospital on May 1 03 he reports making steady improvement during the first few weeks and began to walk using a walker. However, a week before his scheduled discharge in mid-June he relapsed. Noteworthy medical history includes new onset cough and dry rash on the neck, chest, back, abdomen, arms and thighs in Feb 00 while in over-seas. He states the rash looked like ringworm and was treated with a cream after which it resolved. The cough was non-productive and continuous and was treated with inhalers. The cough lasted for 2 years the member reports. In Mar 00 intermittent hoarseness began. By Apr 00 the hoarseness became constant and on bro. Follow up on 10/28/2003: Vaccine recipient did not recover from adverse events.  I have sent in an update on this patient already and we have determined that his condition is not vaccine-related.  He had neurologic complications of sarcoidosis.					Y	90		Y	N	11/06/2002	11/13/2002	7	MRI brain normal study; MRI lumbar spine degenerative dsk disease at L5-S1 with a diffuse dsk bulge effacing the epidural fat. No spinal stenosis. No neural impingement, multi-level degenerative facet arthropathy. MRI C, T and L-spine no	MIL	MIL	NONE	NONE	Cough; Dry rash on neck, chest, back, abdomen, arms and thighs; Hoarseness; Atropy of the right supraspinatus muscle; Beta Thalassemia, sickle cell trait; Vocal cord dysfunction; Vocal cord surgery			1						1	Balance disorder; Cough; Difficulty in walking; Dysphonia; Guillain-Barre syndrome; Hypoaesthesia; Laboratory test abnormal; Paraplegia; Pyrexia; Rash; Sarcoidosis; Urinary incontinence	FLU3~SANOFI PASTEUR~U0983AA~5~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0206635	07/25/2003	OH	24.0	24		F	07/16/2003	Patient presented to ER via ambulance with an anaphylactic reaction to a flu shot. Shortly after receiving a flu shot at work, patient experienced itching, numbness to extremities, weakness, shortness of breath, and eventually became cyanotic. Epipen was administered and life squad called. IV was started and aerosols were given en route. Upon arrival to ER patient was blue and hypotensive. Treatment included hydration, Solumedrol, Pepcid, Benadryl, and aerosol treatments. Patient was still short of breath and was admitted to ICU for observation. History and physical revealed that patient had a similar reaction to iodine IVP dye two years ago. Reaction resolved and patient was discharged the next day. A follow up report received 11/21/2003 adds: (in hospital) Pt improved and was discharged 2 days later.			Y		Y	2			Y	10/08/2002	10/08/2002	0	NONE	OTH	OTH	Allegra and birth control pills	NONE	Iodine IVP dye; asthma, endometriosis			1						1	Anaphylactic reaction; Asthenia; Cyanosis; Dyspnoea; Hypoaesthesia; Hypotension; Pruritus	FLU3~SANOFI PASTEUR~U0087~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0206662	07/25/2003	MO	22.0	22		M	07/25/2003	This was a series of 6 shots. 1st shot was 17March98. Swelling/soreness @ injection site. Nasal/sinus congestion with muscle burning in back and neck. Weakness over whole body. All symptoms lasted approximately 6 days. The 4th injection was on 10/13/98. I recieved flu-vaccine and Hepatitis B vaccine shots with the 4th injection of Anthrax. Five hours later I began to have fever, muscle aches over entire body, headache, chills, head congestion, nausea, diarrhea, stomach pain, and fatigue. These symptoms lasted a week. I felt like I was dying. On 29Oct99 I received 5th Anthrax shot with 3rd Hep. B shot. Lot #'s FA044, 7953A4. Four weeks later I had a Flu shot. I had flu-like symptoms for 2 weeks starting 29Oct99, and for another week after the flu shot the following month.									N	10/13/1998	10/13/1998	0		MIL	MIL	flexiril, tylenol, midrin, ibuprofen, naproxen sodium		chronic pain in neck and back, migraine headaches	Pain, Swelling, flu-like~Anthrax (no brand name)~1~22.10~In Patient		1						1	Abdominal pain upper; Asthenia; Chills; Diarrhoea; Fatigue; Head discomfort; Headache; Injection site oedema; Injection site pain; Musculoskeletal discomfort; Myalgia; Nasal congestion; Nausea; Pyrexia; Sinus congestion	ANTH~MICHIGAN DEPT PUB HLTH~FAV017~4~SC~RA~ANTHRAX (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~0970170~3~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~2506A4~2~IM~LA~HEP B (ENGERIX-B)~1	USA		Influenza
0206717	07/29/2003	ME	70.0	70		M	07/24/2003	Awoke 13th day after flu shot paralyzed from waist down. Never recovered. In wheelchair; perfectly healthy before this. In 11/91 13 days after a flu shot, I awoke paralyzed from the waist down. Went to our doctor then to hospital ER. Called it acute ideopathic polyneuropathy fter x-rays and cat scan. Finally went to the hospital and then to another clinic where they thought it was GBS. Later transverse myelitis. From there to nursing home where I've been in a wheelchair ever since. Completely paralyzed from waist down with incontinence. The hospital discharge summary received on 1/2/04 states congenital malformation, spasticity, and neurogenic bladder.								Y	N	11/02/1991	11/15/1991	13		PUB	PUB	Kerlon; Baby aspirin	NONE	NONE			1						1	Congenital anomaly; Hypertonia; Paralysis; Polyneuropathy; Urinary incontinence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0206890	08/01/2003	AZ	75.0	74		M		A 75 year old male received RSV vaccine of Placebo and Influenza vaccine in the RSV 11 study on Oct 10, 2002 and on June 18, 2003, 251 days later was admitted to impatient hospice for pain management of spinal stenosis OA. Patient's wife called to site to say patient had passed away July 11, 2003, 274 days after vaccination. The investigator assessed the event as unrelated to the study product. Further information has been requested.  On March 7, 2003 148 days after vaccination the patient developed pneumonia and was admitted to hospital on March 7, 2002. The patient was given steroids. From follow up information received April 4, 2003 the pneumonia symptoms were ongoing.Discharge summary for March 7, 2003 to March 12, 2003. Diagnosis: left lower lobe pneumonia, chronic obstructive pulmonary disease, coronary artery disease, diabetes, hyperlipidemia. Hospital course: The patient was admitted with shortness of breath. He was found to have a left lower lobe infiltrate on chest x-ray. He was treated with oxygen and IV tequin. Blood cultures werenegative. Sputum culture grew out only usual oral flora. The patient continued to have shortness of breath. Steroids were added. He had hyperglycemia related to that, but did ultimately improve. He leaves here with normal white count. He ias being discharged to home with medications as prior to admit. He was told that his blood sugars will improve as he is rapidly tapered off of his Prednisone. He will be on Tequin 400mg po qd for five more days and Prednisone 20/20,10/10,5/5 and then off. He will follow up with his primary care ohysician. It is recommended that in one to two weeks, he have a follow up chest x-ray to assure clearing of his infiltrate. From follow up information received June 6, 2003-Diagnosis left lower lobe pneumonia,COPD outcome recovered. From follow up information received June 22, 2003 : Emergency dept report 03/07/2003. This is a 75 year old male who presents to the emergency dept with his wife. He states that he has had a fever every night for the last two weeks. He was diagnosed with oneumonia in the first on March and just finished a Z pack and really dose not feel any better. He says he has been coughing up some grayish brownish sputum but today he has not been able to cough anything up. He just really feels miserable. He feels more miserable today than he has. He denies any chest pain. He denies any abdominal pain, denies any nausea, vomiting, diarrhea. He denies any extremity swelling. He feels generally weak and bad. Review of system: The review of sytems is otherwise negative. This is a well developed well nourished elderly male, resting on the cart. He appears tachypneic with some conversational dyspnea. Skin is warm and dry. There are no rashes or lesions. He appears well hydrated. HEENT Normocephalic, atraumatic. Eyes, ears, nose and mouth normal. Neck Supple and non tender. No obvious asymmetry or palpable mass. He has no increased jugular venous pressure noted. Hearts: regular rate and rythm. Lungs: significant for decreased air movements in his bases bilaterally. Abdomen Normoactive bowel sounds, soft, no palpabe masses or tenderness. No rebound, guarding or peritoneal signs. Extremities: no clubbing, cyanosis or edema.  Here in the emergency dept, chest x-ray, CBC comprehensive metabolic panel, blood cultures x 2. EKG were performed. His chest x-ray interpreted by myself was significant for right hilar infiltrate as well as what looks like a left lower extremity pneumonia. His white count is 10,200, hemoglobin and hematocrit 13.4 and 39.6 respectively with 211,000 platelets 77.2 % granulocytes, 7.9 absolute granulocytes on his differential. His glucose is elevated at 140 and otherwise all values on his comprehensive metabolic panel are within normal limits. EKG interpreted by myself is a normal sinus rhythm, rate 90, axis normal. Itervals are within normal limits. No evidence of acute injury, ischemia or infarction. Emergency dept course and interventi	Y	07/11/2003							N	10/10/2002	06/18/2003	251	Medical procedures, medications: Oxygen March 7, 2003, Tequin March 7, 2003, Blood cultures negative, Tequin March 12-16, 2003, Prednisone tapor 20mg-DC March 12, 2003---Blood pressure 123/83, pulse 92, respirations 28, temp 101.6 orally, O2 sat 93% on three liters	UNK	UNK	Furosemide, Aldactone, potassium chloride, Verapamil, HCL, Glyburide, Leva Thyroxine, Simvastatin, Ibuprofen, ASA, vitamin E, vitamin C, visicer formula, Albuterol, Atrovent, Vancenase, SVN albuterol/Atrovent, Tequin, Prednisone, oxygen, hy		CABG x 5, CHF, HTN, CAD, hypercholesterolemia, L ventricular dysfunction, COPD, pulmonary fibrosis, diabetes-type 2, spinal stenosis, severe OA.		200301447	1						1	Asthenia; Cold sweat; Coronary artery disease; Cough; Diabetes mellitus; Dyspnoea; Hyperlipidaemia; Lung disorder; Pain; Pallor; Pneumonia; Tachypnoea	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0191523	08/05/2003	CT	75.0	75		F	07/30/2003	Info has been received from a registered nurse concerning a 75 year old female pt with no known allergies, who on 10/11/2002 was vaccinated in the arm with a 2nd dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). The 1st dose of pneumococcal vaccine 23 polyvalent was administered in approx 1993. Concomitant vaccination with the 2nd dose included a dose of influenza virus vaccine in the other arm. On 10/12/2002 the pt developed a rash on her abdomen. By 10/13/2002 the rash was on her back from her neck to her buttocks, and on both of her arms down to her wrists. Medical attention was sought. On 10/13/2002 the pt was hospitalized, but no diagnosis was given. The pt was treated with antibiotics and was discharged from the hospital on 10/16/2002. The nurse reported that the pt was told, never to have a flu shot again. Additional info has been requested.				Y	Y	4	Y		U	10/11/2002	10/12/2002	1	UNK	OTH	OTH			UNK		WAES0210USA01813	1						4	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~4|PPV~MERCK & CO. INC.~0445M~2~~~PNEUMO (PNEUMOVAX)~4	USA	Hospitalisation	Influenza
0191531	08/05/2003	CT	52.0	52		F	07/30/2003	Info has been received from a registered nurse concerning a 52 year old female employee with no known allergies and a past medical history of pneumonia, who on 10/14/2002 was vaccinated in the left arm with a 2nd dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). The 1st dose was administered in approx 1993. Concomitant vaccination with the 2nd dose included a dose of influenza virus vaccine in the right arm. By 10/16/2002 the pt had developed a rash and cellulitis on her left arm. The pt went to her doctor who prescribed antibiotics and cortisone cream, but she did not use the cream. Additional info has been requested.				Y					U	10/14/2002	10/16/2002	2	UNK	OTH	OTH			Pneumonia		WAES0210USA01866	1						2	Cellulitis; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0445M~2~~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0192079	08/05/2003	GA	59.0	59		F	07/30/2003	Info has been received from a pharmacist and a woman in a medical office concerning a 59 year old female who on 10/17/2002 at 10:00 was vaccinated in the left deltoid with a dose of pneumococcal vaccine 23 polyvalent (lot #642749/0111M). Concomitant therapy included influenza virus vaccine (FLUZONE) (lot #V0875AA). On 10/17/2002 at 16:00 the pt developed significant redness and swelling at the injection site (left shoulder/arm). It was noted that there was also fever at the injection site. The health professional reported that an ER/doctor visit was required, and subsequently, the pt recovered from the experience. No additional info is expected.				Y					Y	10/17/2002	10/17/2002	0	UNK	OTH	OTH			UNK		WAES0210USA02678	1						2	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~V0875AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0111M~UNK~~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0192167	08/05/2003		65.0	65		F	07/30/2003	Information has been received from a pharmacist concerning a 65 year old female who on 10/11/02 was vaccinated in the left arm with a first dose of pneumococcal vaccine 23 polyvalent (641531/1352L). Concomitant therapy included a dose of the influenza virus vaccine. On approximately 10/12/02, within 24 hours of the vaccine administration, the pt developed an injection site reaction and her face swelled. The pt sought medical attention and was treated with meclizine and prednisone. Additional info has been requeste.				Y					U	10/11/2002	10/12/2002	1	UNK	OTH	OTH			UNK		WAES0210USA02312	1						2	Face oedema; Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~1352L~1~~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0192206	08/05/2003		90.0	89		F	07/30/2003	Info has been received from a pharmacist concerning a 90 year old female who on 12/17/2001 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent (lot #637093/0802L). Concomitant therapy included a dose of the influenza virus vaccine (manufacturer unknown). Subsequently, the pt developed itching and swelling at the injection site in the left arm. The pt sought medical attention and was treated with fexofenadine (ALLEGRA) and ice. Additional info has been requested.				Y					U	12/17/2001	12/17/2001	0	UNK	OTH	OTH			UNK		WAES0210USA02429	1						2	Injection site oedema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0802L~UNK~~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0192573	08/05/2003	OR	78.0	78		F	07/30/2003	Information has been received from a RN concerning a 78 year old female pt with spinal stenosis, hypertension, myelodysplasia and a history of a cerebrovascular accident who on 10/24/02 at 14:30pm was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (641531/1352L or 643504/0735M). Concomitant vaccine therapy included a dose of influenza virus vaccine (Fluzone) in the left deltoid (U0872AG). Concomitant therapy included Vioxx 25mg daily, Norvasc 5mg dialy, diovan HCT, Detrol and iron pills. There was no illness at the time of vaccination. On 10/24/02 at 16:00 pm, the pt developed acute swelling, exquisite tenderness and moderate erythema of the right deltoid. Subsequently, the pt recovered. Unspecified medical attention was sought. Additional info has been requested.				Y					Y	10/24/2002	10/24/2002	0	NONE	PVT	PVT	Norvasc; Diovan HCT; iron; Vioxx; Detrol		Cerebrovascular accident; hyypertension NOS: myelodysplasia; spinal stenosis NOS		WAES0212USA01738	1						2	Erythema; Oedema peripheral; Tenderness	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1352L~UNK~~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0192705	08/05/2003	OR	78.0	78		F	07/30/2003	Information has been received from a RN concerning a 78 year old female pt with diabetes mellitus who on 10/16/02 at 10am was vaccinated IM in the right deltoid with a first dose of pneumococcal vaccine 23 polyvalent (641531/1352L or 643504/0735M). Concomitant vaccine therapy included a dose of influenza virus vaccine (Fluzone) given IM in the left deltoid (UC892AS). There was no illness at the time of vaccination. On 10/16/02 at 16:30pm the pt's husband called her physician's office and reported that at 14:00pm her right arm became swollen and quite painful. It was reported that it resolved in a few days with ice and ibuprofen. Subsequently, the pt recovered. Additional info has been requested.									Y	10/16/2002	10/16/2002	0	UNK	PVT	PVT			Diabetes mellitus NOS		WAES0212USA01739	1						2	Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~UC892AS~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1352L~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0192723	08/05/2003	NC	52.0	52		F	07/30/2003	Information has been received from an office worker and physician concerning a 52 year old white female with hypothyroidism who just finished treatment for ovarian cancer and has allergies to penicillin, cephalexin, tetracycline, clarithromycin, erythromycin, Dextran, Methogen and Telectin. During exercise the patient does not flush or get hives but feels very itchy, which her physician determined may be some sort of histamine release. On 10/29/02 the patient was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent IM in the right deltoid (640577/0995L). On the same day the patient was vaccinated with the influenza virus vaccine 0.5cc, IM, in the left deltoid (U0933AA). On 10/29/02 the patient developed erythema, redness, soreness, edema, and weakness in the injected arm. She further reported that the injected arm was painful to move for four days. The patient reported a fever of 100 degrees F. On 10/30/02 the patient was seen in the office. Her blood pressure was 106/68, pulse 64 and temperature 98.3. The upper aspect of the right arm had some swelling and erythema. No axillary nodes noted. The area was tender to touch, no bruising. It was painful for the patient to lift her arm. No high fever and no prior pneumonia vaccine was administered. The patient was treated with ice, ibuprofen 600mg three times a day and fexofenadine 60mg twice a day. By 11/6/02, or sooner, the patient recovered without incident. The physician felt the events were related to the pneumonia vaccine. No further information is expected.				Y					Y	10/29/2002	10/29/2002	0	BP 106/68; Body temp 100F	OTH	OTH			Pruritus; Drug Hypersensitivyt; Hypothyroidism; Ovarian Cancer		WAES0211USA00326	1						2	Blood pressure decreased; Injection site erythema; Injection site pain; Injection site swelling; Joint range of motion decreased; Pyrexia	FLU3~SANOFI PASTEUR~U0933AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0995L~1~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0192743	08/05/2003	OR	52.0	52		F	07/30/2003	Information has been received from a registered nurse concerning a 52 year old female patient with no medical history and no allergies who on 10/26/02 at 10AM was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent. Concomitant vaccine therapy included a dose of influenza virus vaccine (lot # E301126A) IM in the right deltoid. There was no illness at the time of vaccination. One hour after the patient received the injection her arm immediately developed some slight swelling. It continu8ed to swell and became hot and inflamed. The patient was diagnosed with cellulitis. On 1/27/03, it was reported that the patient was evaluated at a physician's office on 10/20/02 and treated with dicloxacillin for one week and had not called regarding this matter since that day. Additional information has been requested.				Y					U	10/26/2002	10/26/2002	0	UNK	OTH	OTH			NONE		WAES0211USA00085	1						2	Cellulitis; Injection site inflammation; Injection site swelling; Injection site warmth	FLU3~EVANS VACCINES~E301126~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~~1~~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0193637	08/05/2003	NY	75.0	75		F	07/30/2003	Info has been received from a physician concerning a 75 year old (previously reported as 73 year old) female with no past medical history and no known allergies who in 1997 and on 10/14/2002 (previously reported as 10/15/2002) was vaccinated with the 1st and 2nd doses respectively of pneumococcal vaccine 23 polyvalent in the left deltoid (lot #640981/1050L). Concomitant therapy, that same day, included a dose of influenza virus vaccine (FLUVIRIN) given in the right deltoid (lot #E33362GA). Other concomitant therapy included warfarin sodium (COUMADIN), diltiazem hydrochloride (CARDIZEM CD), terazosin hydrochloride (HYTRIN), oxybutyninCl (DITOPAN), and atorvastatin calcium (LIPITOR). There was no illness at the time of vaccination. On 10/15/2002, the pt developed severe swelling and soreness which was hot to touch at the injection site. The left arm was red and warm with edema from the deltoid to the wrist. On 10/17/2002, the pt presented to her physician's office with cellulitis. On 10/20/2002, the pt recovered. No further info is available.				Y					Y	10/14/2002	10/15/2002	1	NONE	PVT	PVT	Lipitor, Cardizem CD, Ditropan, Hytrin, Coumadin		NONE		WAES0210USA01937	1						2	Injection site erythema; Injection site oedema; Injection site warmth; Pain	FLU3~EVANS VACCINES~E33362GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~1050L~2~~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0193944	08/05/2003	FL	50.0	50		F	07/30/2003	Info has been received from a 50-year-old female with hypertension and a penicillin allergy who on 10/29/2002 was vaccinated in the right arm with a dose of pneumococcal vaccine 23 polyvalent. Concomitant vaccination the same day included a dose of influenza virus vaccine given in the left arm. Other concomitant therapy included hydrochlorothiazide (manufacturer unknown), atenolol and fosinopril sodium (MONOPRIL). On 10/29/2002 on the return home from her vaccination, the pt developed extreme swelling, fever and chills. Unspecified medical attention was sought. As of 11/06/2002, the pt had not recovered. On 11/11/2002 the pt reported that her right arm was getting better but still had some bruising. The swelling had gone down. The pt reported that she was having these reactions in the arm that was vaccinated with pneumococcal vaccine 23 polyvalent. Additional info has been requested.				Y					N	10/29/2002	10/29/2002	0	UNK	OTH	OTH	Atenolol, Monopril, Hydrodiuril		Hypertension, penicillin allergy		WAES0211USA00684	1						2	Injection site oedema; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~UNK~~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0194276	08/05/2003	MD	44.0	44		F	07/30/2003	information has been received from a health professional concerning a 44 year old female patient with a history of asthma and no illness at time of vaccination who on Nov 21, 2002 was vaccinated subcutaneously in the left arm with a first doe of pneumococcal vaccine 23 polyvalent (lot #643503/0541M). Concomitant therapy on Nov 21, 2002 included an intramuscular dose in the right arm influenza virus vaccine (Fluvirin) (lot # E8162GA) (it was noted that the patient had several previous doses). On Nov 22, 2002, the patient developed cellulitus in the left arm at the injection site for two days. The patient was treated with antibiotics and subsequently recovered. It was also reported that one male (WAES0212USA00380) and two other female patients (WAES0211USA02439) developed cellulitus at the injection site. The symptoms of two of the patients cleared up without event. Two patients were seen over the weekend within a day or two of injections and at the time of this report follow up had not occurred. No further information is expected.				Y					Y	11/21/2002	11/22/2002	1	UNK	PVT	PVT			Asthma NOS		WAES0302USA00556	1						2	Cellulitis	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~0541M~1~SC~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0194404	08/05/2003	MS	13.0	13		F	07/30/2003	Info has been received from a licensed practical nurse concerning a 13 year old pt who on 11/13/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #643504/0735M). On 11/15/2002 the pt developed weakness and a fever of 102.5. Unspecified medical attention was sought. The pt's experience resolved in a few days. The reporter mentioned that a 2nd pt also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (MSD) (Lot #643504/0735M) (WAES #0301USA00179). Additional info has been requested. Follow up: The reporter mentioned that the pt's subling also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (MSD) (Lot #643504/0735M) (WAES #0301USA00179). Additional info is not expected.				Y					Y	11/13/2002	11/15/2002	2	Body temp (11/15/02) 102.5	OTH	PVT	UNK		Attention deficit/ hyperactivity disorder	~Pneumo (no brand name)~~10.00~In Sibling	WAES0211USA02555	1						3	Asthenia; Pyrexia	FLU3~SANOFI PASTEUR~~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~0735M~3~IM~~PNEUMO (PNEUMOVAX)~3	USA	Emergency room visit	Influenza
0194427	08/05/2003	OH	72.0	72		M	07/30/2003	Info has been received from a registered nurse concerning a 72 year old male on therapy with aspirin, a history of a pneumococcal vaccination (manufacturer unknown) (date unspecified) and with no other past medical history who on 10/08/2002 was vaccinated IM in the left deltoid with a dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0045M) and vaccinated, in the same arm, with concomitant suspect therapy tetanus toxoid. On 10/09/2002, 24 hours after administration, the pt developed redness and swelling in the arm that was injected. The pt was treated with a cold compress and diphenhydramine (BENADRYL), oral administration. The outcome of the pt's redness and swelling was unknown. The reporter expressed a concern regarding the lot number. Conflicting info has been received from a registered nurse. The registered nurse reported that on 10/08/2002 the pt was vaccinated IM in the left deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent and vaccinated IM in the right deltoid with a dose of influenza virus vaccine (FLUZONE) (lot #U0913AA). The nurse also reported that on 10/08/2002, in the evening after the vaccination, the pt's arm that received the pneumococcal vaccine 23 polyvalent injection became red, swollen, painful and warm to touch. The area of inflammation extended from the deltoid to the wrist. The nurse recommended cold compresses, elevation and ibuprofen (ADVIL) to the pt, and subsequently, the symptoms lasted 3-4 days, then subsided. No additional info is expected. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The nurse also reported on 2 other patients that experienced a similar reaction (WAES #0210USA01284) and (WAES #0210USA01872).				Y					Y	10/08/2002	10/08/2002	0	UNK	PUB	PUB	Aspirin				WAES0210USA01873	1						2	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U0913AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0445M~1~IM~LA~PNEUMO (PNEUMOVAX)~2|TTOX~UNKNOWN MANUFACTURER~~UNK~~~TETANUS TOXOID (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0194429	08/05/2003	OH	75.0	75		M	07/30/2003	Information ahs been received from a registered nurse concerning a 75 year old male with no known drug allergies and no past medical history who on Oct 01, 2002 at 02:00pm was vaccinated IM in the right deltoid with a second dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M), and vaccinated IM in the left deltoid with a dose of influenza virus vaccine (Fluzone) (Lot #U0913AA). There was no illness at the time of vaccination. It was reported that the patient received a prior dose of pneumococal vaccine 23 polyvalent a long time ago. On Oct 02, 2002, at 07:00pm, 24 hours after administration, the patient developed redness and swelling in the arm that was injected. The patient was treated with a cold compress and diphendramine HCL (Benadryl),oral administration. The outcome of the patient's redness and swelling was unknown. The reporter expressed a concern regarding the lot number. Conflicting information has been received from a registered nurse. The registered nurse reported that on Oct 01, 2002 at 07:00pm, in the evening after the injection, the patient developed redness and swelling of his right arm, from the deltoid muscle down to his wrist, involving all but the inner aspect of his upper arm. The registered nurse also reported that there was fluid accumulation around the elbow, some tenderness of the elbow, and discomfort on moving. The patient was advised elevation, ice and ibuprofen (Advil). The patient's experience lasted 3-4 days, and subsequently , the patient recovered. It was reported to be unknown if laboratory diagnostics were performed. No additional information is expected. The records of testing prior to release of this lot have been checked by compliance and found to be satisfactory. The lot complies with the standards of the evaluation and research and was released.				Y					Y	10/01/2002	10/01/2002	0	UNK	PUB	PUB			NONE		WAES0210USA01284	1						2	Injection site erythema; Injection site oedema; Tenderness	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0445M~2~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0194454	08/05/2003	OH	71.0	71		F	07/30/2003	Info has been received from a registered nurse concerning a 71 year old female with a history of pneumonia and vaccination with a pneumococcal vaccine (manufacturer unknown) (date unspecified) who on 10/08/2002 was vaccinated IM in the left deltoid with a dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M) and vaccinated, in the same arm, with a dose of concomitant suspect therapy tetanus toxoid. On 10/09/2002, 24 hours after administration, the pt developed redness and swelling in the arm that was injected. The pt was treated with a cold compress and diphenhydramine HCl (BENADRYL), oral administration. The outcome of the pt's redness and swelling was unknown. The reporter expressed a concern regarding the lot number. Conflicting info has been received from a registered nurse. The registered nurse reported that on 10/08/2002 the pt was vaccinated at 14:00 IM in the left deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M) and vaccinated IM in the right deltoid with a dose of influenza virus vaccine (FLUZONE) (lot #U0913AA). The nurse also reported that on 10/08/2002 at 19:00 in the evening after the vaccination, the pt's arm that received the pneumococcal vaccine 23 polyvalent became red, swollen, painful and warm to touch. The affected area extended from the deltoid muscle to the elbow. The pt was treated with cold compresses, and subsequently, the pt recovered. No additional info is expected. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The nurse also reported that 2 other patients experienced similar reactions (WAES #0210USA01873) and (0210USA01284).				Y					Y	10/08/2002	10/08/2002	0	UNK	PUB	PUB			Pneumonia		WAES0210USA01872	1						2	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U0913AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0445M~1~IM~LA~PNEUMO (PNEUMOVAX)~2|TTOX~UNKNOWN MANUFACTURER~~UNK~~LA~TETANUS TOXOID (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0194508	08/05/2003	MS	10.0	10		M	07/30/2003	Information has been received from a licensed practical nurse concerning a 10 year old male patient with ADHD and allergies to cefaclor (Ceclor), cefprozil (Cefzil),lorcarbef (Lorabid) and cefpodoxime proxetil (Vantin) who on Nov 13, 2002 at 10:15 was vaccinated intramuscularly in the right anterior thigh with a first dose of pnemococcal vaccine 23 polyvalent (lot#643504/0735M). Concomitant vaccination included an intramuscular seventh dose in the left anterior thigh of influenza virus vaccine (Fluzone) (lot #U0971AA). There was no illness at the time of vaccination. On Nov 15, 2002 in the am, the patient developed a big red welt also described as a knot at the injection site on the right anterior thigh. The patient also developed a rash on the left anterior thigh. the patient was afebrile. The patient was treated at home by the mother who is a medical doctor. On Nov 19, 2002, the patient recovered. The reporter mentioned that the patient's sibling also had a experience following vaccination with pneumococcal vaccine 23 polyvalent (lot #643504/0735M) (WAES0211USA02555). Additional information is not expected.				Y					Y	11/13/2002	11/15/2002	2	UNK	PVT	PVT			Attention deficit/hyperactivity disorder: drug hypersensitivity	~Rubella (Meruvax II)~~13.00~In Sibling	WAES0301USA00179	1						2	Injection site erythema; Injection site mass; Rash; Urticaria	FLU3~SANOFI PASTEUR~U0971AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0735M~1~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0194826	08/05/2003	IL	27.0	27		F	07/30/2003	Information has been received from a woman in a physician's office concerning a 27 year old female patient who on Dec 03, 2002 at 2:00 pm was vaccinated by intramuscular injection in the left deltoid with a dose of pneumcoccal vaccine 23 polyvalent (lot #644107/0955M). Concomitant therapy given at same time included vaccination by an intramuscular injection in the right deltoid with a dose of influenza virus vaccine (Fluvirin) (lot # reported as E33902HA). The reporter indicated the patient called the clinic office at 14:30 on Dec 4, 2002 and reported her left arm was red with rash, and she had pain in the vaccinated arm, which was described as left arm hurt a lot. It was also indicated she had swelling in the vaccinated arm. it was noted the physician office told her to apply an ice pack and take acetaminophen (Tylenol). The reporter indicated the patient was instructed to return to the clinic if she was not better. It was reported that the patient recovered. the reporter has requested a lot check. The records of testing prior to release of this lot have been checked by compliance and found to be satisfactory. The lot complies with the standards of the center for evaluation and research and was released. The reporter mentioned another patient also had experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES021201636).									Y	12/03/2002	12/04/2002	1	UNK	PVT	OTH			UNK		WAES0212USA02009	1						2	Injection site erythema; Injection site oedema; Pain; Rash	FLU3~EVANS VACCINES~E33902HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~0955M~UNK~IM~LA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0195751	08/05/2003		68.0	68		F	07/30/2003	Info has been received from a registered nurse concerning a 68 year old female pt who was vaccinated with the first documented dose of pneumococcal vaccine 23 polyvalent (lot #641329/1264L). Subsequently, 6 hours after administration, the pt developed chills, sweating, low grade fever, arm pain, swelling and redness. The swelling reportedly remitted 3 days later, but still had joint pain. The pt sought unspecified medical attention. It was also reported that 2 other pts (WAES #0210USA02453 and 0211USA01412) experienced symptoms after vaccination with pneumococcal vaccine 23 polyvalent. Additional info has been requested.				Y					N	10/17/2002	10/17/2002	0	UNK	OTH	OTH	UNK		UNK		WAES0211USA01411	1						2	Arthralgia; Chills; Hyperhidrosis; Injection site erythema; Injection site pain; Injection site swelling; Nausea; Pyrexia; Chills; Hyperhidrosis; Injection site erythema; Injection site oedema; Pain; Pyrexia	FLU3~SANOFI PASTEUR~UO968AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1264L~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~1264L~1~~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0203067	08/05/2003	OH	69.0	69		M	07/30/2003	Information has been received from a registered nurse concerning a 69 year old male with no medical history and no allergies who on Feb 14, 2003 at 14:30 was vaccinated intramuscularly in the right deltoid with a second dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M). Concomitant vaccination given intramuscularly in the left deltoid included a dose of influenza virus vaccine (Fluzone) (lot #U0949AA). There were no other concomitant medications. There was no illness at the time of vaccination. There were no adverse events following priori vaccinations. On the morning of Feb 15, 2003 the patient's right upper arm became red, swollen, and painful to move. The redness and swelling extended from the shoulder to below the elbow. The symptoms began improving 4 days after the shot was given on Feb 18, 2003. It was noted that the patient recovered. Additional information is not expected.									Y	02/14/2003	02/15/2003	1	UNK	PUB	PUB			NONE		WAES0302USA02515	1						2	Injection site erythema; Injection site swelling; Pain; Erythema; Joint range of motion decreased; Oedema; Pain; Hypokinesia; Injection site erythema; Injection site oedema; Pain	FLU3~SANOFI PASTEUR~U0949AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0445M~2~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0445M~2~IM~~PNEUMO (PNEUMOVAX)~2|FLU3~SANOFI PASTEUR~U0949AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~0445M~2~IM~RA~PNEUMO (PNEUMOVAX)~3	USA		Influenza
0203067	08/05/2003	OH	69.0	69		M	07/30/2003	Info has been received from a registered nurse concerning a 69 year old male pt with no known allergies, no relevant medical history and no illness at time of vaccination who had first dose of pneumococcal vaccine 23 polyvalent in 1997 and on 02/14/2002 received a 2nd dose of pneumococcal vaccine 23 polyvalent (643251/0445M) intramuscularly in the right deltoid. Concomitant therapy that day at 2:30 PM included a dose of influenza virus vaccine (Fluzone) (lot #U0949AA) intramuscularly in the left deltoid. On 02/15/2003 the pt developed a red arm, swollen from upper shoulder to and including the elbow. The pt's arm was very painful and difficult to move. On 02/17/2003 (day 4) when the pt contacted the office, the reaction was beginning to subside. It was noted that ibuprofen (Advil) was suggested, but probably not taken. The reporter had a concern about the lot and was hesitant to use the remainder of the vials. The reporter requested that lot be looked at. Follow up info revealed that the pt had no symptoms following prior vaccination and on 02/15/2003 in the AM, the morning after shots were given, the pt's right upper arm was red, swollen and painful to move. The redness and swelling extended from shoulder to below elbow. No diagnostic tests were reported. It was noted that symptoms began improving 4 days after shots were given and subsequently the pt recovered. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.				Y					Y	02/14/2003	02/15/2003	1	UNK	PUB	PUB			NONE		WAES0302USA02154	1						3	Injection site erythema; Injection site swelling; Pain; Erythema; Joint range of motion decreased; Oedema; Pain; Hypokinesia; Injection site erythema; Injection site oedema; Pain	FLU3~SANOFI PASTEUR~U0949AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0445M~2~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0445M~2~IM~~PNEUMO (PNEUMOVAX)~2|FLU3~SANOFI PASTEUR~U0949AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~0445M~2~IM~RA~PNEUMO (PNEUMOVAX)~3	USA	Emergency room visit	Influenza
0204787	08/05/2003	TN				F	07/30/2003	Info has been received from a female with no known drug allergies and no past medical history who on 10/04/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown). The pt was unsure if it was the pneumococcal vaccine 23 polyvalent. Subsequently, the pt developed a cough, fever, sore throat, cold sweats, chills and her arm that she got the shot in became swollen and painful. Subsequently, the pt went to the ER and since that time has reported to continue to feel sick. The pt sought unspecified medical attention. Additional info has been requested. The wife also reported info on her husband's experience (WAES #0210UA02854).				Y					N	10/04/2002	10/04/2002	0	UNK	OTH	OTH	UNK		NONE		WAES0210USA02582	1						2	Chills; Cough; Headache; Injection site erythema; Injection site oedema; Injection site pain; Muscle spasms; Nausea; Pharyngolaryngeal pain; Chills; Cough; Hyperhidrosis; Injection site oedema; Pain; Pharyngolaryngeal pain; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~PFIZER\WYETH~~UNK~~LA~PNEUMO (PNU-IMUNE)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0207009	08/05/2003	WV	51.0	51		M	07/28/2003	He had fever and weakness about three hours after vaccinated on 10/16/00 and never received treatment until 3/24/01 and was not drained in the spine. Abdominal pain, along with constipation. At this time, he has an ileus, and his other complaint is left groin pain, which has be undiagnosed. He kept going into shock up until December. I think his sed rate was still high even though it was in the normal range because his heart was infected, and they didn't send him home with no antibiotics. GBS caused from the vaccines.			Y	Y	Y	45	Y	Y	N	10/16/2000	10/16/2000	0		MIL	MIL	Albuteral, Metrobedrol	Fever, weakness	Asthma, sleep apnea, polyps in nose			1						1	Abdominal pain; Constipation; Groin pain; Guillain-Barre syndrome; Ileus; Infection; Red blood cell sedimentation rate increased; Shock	FLU3~SANOFI PASTEUR~~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~471865~2~~RA~PNEUMO (PNU-IMUNE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0207095	08/05/2003	TX	36.0	36		F	07/30/2003	Info has been received from a physician and a 36 year old female medical assistant who on 08/27/2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #641532/1353L) intramuscularly in her left arm. Concomitant vaccination included a dose of influenza virus vaccine administered in the right arm. That night the pt developed swelling from her shoulder to her elbow. The injection site had an inner red circle that was surrounded by a larger wheal of redness. The physician reported that the pt experienced a severe local reaction; arthralgia and malaise. The pt also experienced severe arm pain and heat. The pt immediately took acetaminophen (TYLENOL) and diphenhydramine HCl (BENADRYL). Subsequently, she was treated with diphenhydramine HCl (BENADRYL) 50 mg HS. On 09/05/2002 it was reported that the symptoms were subsiding. The reporter expressed a concern with the lot. Five other pts (WAES # 0209USA00030 and 0209USA01591 through 0209USA01594) had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.				Y					N	08/27/2002	08/27/2002	0	UNK	OTH	OTH			UNK		WAES0209USA00016	1						1	Arthralgia; Injection site erythema; Malaise; Oedema; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1353L~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207096	08/05/2003	TX				M	07/30/2003	Information has been received from a male physician who on 8/27/02 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (lot # 641532/1353L) IM in the left arm. Concomitant vaccination included a dose of influenza virus vaccine in the right arm. On approximately 8/29/02 the physician experienced a severe local reaction, swelling from his elbow to his armpit, severe arm pain, redness, heat, arthralgia and malaise. The symptoms radiated to his neck. The physician was treated with a methylprednisone acetate pack for 6 days. On 9/5/02 it was reported that the symptoms were subsiding. The reporter expressed a concern with the lot. Five other patients had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. The records of testing prior to the release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested. Additional information has been requested.				Y					N	08/27/2002	08/29/2002	2	UNK	OTH	OTH			UNK		WAES0209USA00030	1						1	Arthralgia; Erythema; Feeling hot; Malaise; Pain; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1353L~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207105	08/05/2003	TX	55.0	55		F	07/30/2003	Information has been received from a physician concerning his wife who on 8/27/02 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (641532/1353L) IM in the left arm. Concomitant vaccination included a dose of influenza virus vaccine in the right arm. On approximately 8/29/02 the wife experienced a severe local reaction, swelling from her elbow to her armpit, severe arm pain, redness, heat, arthralgia and malaise. The wife was treated with a Depo Medrol pack for 6 days. On 9/5/02 it was reported that the symptoms were subsiding. The reporter expressed a concern with the lot. Five other patients (WAES0209USA00016, 0209USA00030 and 0209USA01592 through 0209USA01594) had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.				Y					N	08/27/2002	08/29/2002	2	UNK	OTH	OTH			UNK		WAES0209USA01591	1						1	Arthralgia; Injection site erythema; Injection site oedema; Injection site pain; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1353L~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207106	08/05/2003	TX	48.0			M	07/30/2003	Information has been received from a physician concerning an approximately 48 year old male pt, who on 8/26/02 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (641532/1353L) in the arm. Concomitant vaccination included a dose of influenza virus vaccine in the other arm. On approximately 8/27/02 the pt experienced an injection site reaction with swelling, warmth and redness the size of a hand. The injection site was painful for 3 to 4 days. The pt was treated with Tylenol and cold compresses. The reporter expressed a concern with the lot. Five other patients (WAES0209USA00016, 0209USA00030, 0209USA01591, 0209USA01593 and 0209USA01594) had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.				Y					Y	08/26/2002	08/27/2002	1	UNK	OTH	OTH			UNK		WAES0209USA01592	1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1353L~1~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207107	08/05/2003	TX	36.0	36		M	07/30/2003	Information has been received from a healthcare professional concerning a 36 year old male pt, who on 8/27/02 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (641532/1353L) IM in the left arm. Concomitant vaccination included a dose of influenza virus vaccine in the right arm. On approximately 8/29/02 the pt experienced a severe local reaction, swelling from his elbow to his armpit, sever arm pain, redness, heat, arthralgia, and malaise. The pt was treated with a Depo Medrol pack for 6 days. On 9/5/02 it was reported that the symptoms were subsiding. The reporter expressed a concern with the lot. Five other patients (WAES0209USA00016, 0209USA00030, 0209USA01591, 0209USA01592 and 0209USA01594) had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.				Y					N	08/27/2002	08/29/2002	2	UNK	OTH	OTH			UNK		WAES0209USA01593	1						1	Arthralgia; Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1353L~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207108	08/05/2003	TX	41.0	41		F	07/30/2003	Information has been received from a healthcare professional concerning a 41 year old female pt, who on 8/27/02 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalnet (641532/1353L) IM in the left arm. Concomitant vaccination included a dose of influenza virus vaccine in the right arm. On approximately 8/29/02 the pt experienced a severe local reaction, swelling from her elbow to her armpit, severe arm pain, redness, heat, arthralgia and malaise. The pt was treated with Depo Medrol pack for 6 days. On 9/5/02 it was reported that the symptoms were subsiding. The reporter expressed a concern with the lot. Five other patients (WAES0209USA00016, 0209USA00030 and 0209USA01591 through 0209USA01593) had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.				Y					N	08/27/2002	08/29/2002	2	UNK	OTH	OTH			UNK		WAES0209USA01594	1						1	Arthralgia; Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1353L~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207116	08/05/2003	NJ	80.0	80		M	07/30/2003	Information has been received from a registered nurse and the wife of an 80 year old male with arthritis NOS and penicillin allergy who on 9/30/02 was vaccinated in the right arm with pneumococcal vaccine 23 polyvalent. Concomitant vaccination on 9/30/02 included influenza virus vaccine in the left arm. Other concomitant therapy included Norvasc, Celebrex, Lipitor, Prilosec. The nurse reported that following the vaccination, the pt felt achy, and tired and had a temp of 102.8. It was also reported that by the next day, the injection site was red and swollen, then the pt's whole arm became red, hot and swollen and the pt had a fever of 103 deg. The pt was seen by a physician and was treated for cellulitis and given Levaquin. The pt's wife reported that the physician believed that the cellulitis was caused not by the vaccine, but by the way it was administered. It was reported  that the vaccine was given without the injection site being swabbed with alcohol. Also, the injection site was not bandaged or covered afterwards. It was also reported that the pt had previously received vaccination with pneumococcal vaccine 23 polyvalent more than 5 years ago without incident. At the time of this report, the outcome of the events was unknown. No further details were available. No further info is expected.				Y					U	09/30/2002	09/30/2002	0	Temp 102.8 9/30/02, 103 10/01/02	OTH	OTH	Norvasc, Lipitor, Celebrex, colchicine, Prilosec		Arthritis NOS; penicillin allergy		WAES0210USA00251	1						1	Cellulitis; Fatigue; Injection site erythema; Injection site oedema; Injection site warmth; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~2~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207129	08/05/2003	AL	76.0	76		F	07/30/2003	Information has been received from a health professional concerning a 76 year old female with no known allergies and no past medical history, who on Oct 07, 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #640981/1050L). Concomitant therapy included influenza virus vaccine (Fluzone). On the night of Oct 07, 2002 the patient developed a local reaction, reported as swelling at the site of injection. When the patient was seen in the physician's office the next day (Oct 8, 2002), it was reported the entire area, from front to back of upper arm, shoulder to elbow was red. Subsequently, the patient recovered. It was noted the patient called the physician office on Oct 11, 2002 and reported her arm was fine and the condition resolved. Unspecified medical attention was sought. The health professional also reported another patient who had an experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES0210USA01291).				Y					Y	10/07/2002	10/07/2002	0	UNK	OTH	OTH			NONE		WAES0210USA01141	1						1	Erythema; Injection site oedema	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1050L~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207136	08/05/2003	AL	45.0	45		F	07/30/2003	Info has been received from a 45-year-old female pt, a registered nurse with questionable drug hypersensitivity to sulfa who on 10/09/2002 in the AM was vaccinated by intramuscular injection in the right deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). Additional therapy given in the AM on 10/09/2002 included an intramuscular injection in the left deltoid with a dose of influenza virus vaccine. The reporter indicated she has a flu vaccine every year. Concomitant therapy included antiinflammatories. On 10/11/2002 the pt developed a reaction over half the arm between the elbow and shoulder, described as redness 4-5 inches from mid bicep to mid tricep, she could not raise her arm, had joint aches, fever of 100.6, blister type appearance of arm, swelling of arm and severe pain. The pt went to her physician on 10/11/2002 and was treated with prednisone, and cephalexin (KEFLEX) (total daily dosage, and stop date not reported). The reporter indicated she did not have any illness at the time of vaccination, and had not experienced any adverse events following prior vaccinations. The reporter requested a lot check. It was noted the pt recovered on 10/18/2002. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter mentioned 13 other patients who also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES #0210USA01734, 0211USA02240, 0211USA02241, 0211USA02242, 0211USA02243, 0211USA02244, 0211USA02245, 0211USA02246, 0211USA02247, 0211USA02248, 0211USA02249, 0211USA02250 and 0211USA02251).				Y					Y	10/09/2002	10/11/2002	2	Body temp 100.6	OTH	OTH			Drug hypersensitivity		WAES0210USA01524	1						1	Arthralgia; Injection site erythema; Injection site oedema; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0445M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207144	08/05/2003	AL				M	07/30/2003	Info has been received from a health professional concerning a male pt who in approximately October 2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). Additional therapy at the same time in the opposite arm included a dose of influenza virus vaccine, flu vaccine. The reporter indicated the pt had a reaction to the pneumococcal vaccine 23 polyvalent. Subsequently, in approximately October the pt developed severe soreness to arm, the pain was rated 10 on a pain scale of 1-10. It was noted he had to go to bed and take pain medication for 48-72 hours. The reporter requested a lot check. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Unspecified medical attention was sought. Additional info has been requested.				Y					U	10/01/2002			UNK	OTH	OTH			UNK		WAES0210USA01734	1						1	Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0445M~1~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207152	08/05/2003	FL	50.0			M	07/30/2003	Info has been received from a physician concerning an approximately 50 year old male physician with Hodgkin's disease diagnosed in 1980 and a history of splenectomy in 1980 who in 1985 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent. No adverse symptoms were noted. In 1990 the pt was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. On the same day, the pt was concomitantly vaccinated with a dose of influenza virus vaccine. Subsequently, the pt developed severe muscle pain and fatigue for 3 days. Unspecified medical attention was sought. No treatment was needed: the condition resolved and no hospitalization was required. No additional info is expected.				Y					Y				UNK	OTH	OTH			Splenectomy; Hodgkin's disease		WAES0210USA01934	1						1	Fatigue; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207160	08/05/2003	NY	60.0			U	07/30/2003	Information has been received from a physician concerning an approximately 60 year old patient who in approximately Oct 2002, was vaccinated in the arm with a dose of pneumococcal vaccine 23 polyvalent (lot# 642722/0165M). Concomitant therapy, that same day, included a dose of influenza virus vaccine in the opposite arm. Within hours of vaccination, in approximately Oct 2002, the patient developed a big time reaction from the deltoid to the elbow. The reaction persisted for 3 to 5 days. The patient received palliative treatment. The physician reported that the patient had priori vaccination with pneumococcal vaccine 23 polyvalent over 5 years ago. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by compliance and found to be satisfactory. The lot complies with the standards of the evaluation and research and was released. The patient sought unspecified medical attention. Additional information has been requested.				Y					Y	10/01/2002	10/01/2002	0	UNK	OTH	OTH			UNK		WAES0210USA02060	1						1	Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0165M~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207170	08/05/2003	PA				U	07/30/2003	Information has been received from a medical assistant concerning a pt who recently, in 2002 was vaccinated with pneumococcal vaccine 23 polyvalent. Concomitant therapy possibly included infleunza virus vaccine. In 2002, the pt developed a local site reaction after vaccination with pneumococcal vaccine 23 polyvalent. This is one of two reports concerning a total of four patients. It was noted that this pt was a re-vaccinee. It was also reported that three of the patients possibly received a flu vaccine in the opposite arm on the same day (WAES0210USA02648). The pt sought unspecified medical attention. Additional info has been requested.				Y					U				UNK	OTH	OTH			UNK		WAES0210USA02347	1						1	Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207171	08/05/2003	NE	84.0	84		F	07/30/2003	Information has been received from a registered nurse concerning an 84 year old female pt with no allergies and no medical history, who on 10/21/02 was vaccinated IM in the right deltoid with a first dose of pneumococcal vaccine 23 polyvalent (640981/1050L). Concomitant vaccination included a first dose of influenza virus vaccine (Fluvirin) (E34722HA) IM in the left deltoid. The pt stated to the nurse that she had received both vaccines in the left arm. However, the nurse confirmed that pneumococcal vaccine 23 polyvalent was administered in the right deltoid. There was no illness at the time of vaccination. On 10/22/02, the pt developed a 10 1/2 by 7 1/2 centimeter area, left arm erythematous, which developed  into mild case of cellulitis, warm to touch. The area was also described as red, raised with induration and swelling was also reported. The pt sought unspecified medical attention and was treated with cephalexin 250mg orally three times a day for 10 days. Subsequently, the pt recovered. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. It was also reported that a second pt experienced an adverse event following vaccination with pneumococcal vaccine 23 polyvalent (640981/1050L) WAES0210USA02516 and a third pt experienced an adverse event following vaccination with pneumococcal vaccine 23 polyvalent (637345/1449K) WAES0210USA02517. Additional info is not expected.				Y					Y	10/21/2002	10/22/2002	1	UNK	PVT	PVT			NONE		WAES0210USA02350	1						1	Cellulitis; Erythema; Feeling hot; Oedema peripheral	FLU3~EVANS VACCINES~E24722HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1050L~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207172	08/05/2003					U	07/30/2003	Information has been received from a pharmacist concerning a pt who on approximately 10/21/02 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent. Concomitant vaccination included a dose of influenza virus vaccine in the right arm. Post vaccination the pt developed swelling of the left arm. Unspecified medial attention was sought. Additional info has been requested.				Y					U	10/21/2002	10/21/2002	0	UNK	OTH	OTH			UNK		WAES0210USA02407	1						1	Oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207174	08/05/2003		56.0	56		F	07/30/2003	Info has been received from a pharmacist concerning a 56 year old female who on 10/15/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #641531/1352L). Concomitant therapy included a dose of the influenza virus vaccine (manufacturer unknown). On approx 10/15/2002, the pt developed a local reaction at the injection site and a fever of 100F. Unspecified medical attention was sought. Additional info has been requested.				Y					U	10/15/2002	10/15/2002	0	Body temp (10/15?/02) 100F.	OTH	OTH			UNK		WAES0210USA02430	1						1	Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1352L~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207175	08/05/2003	FL	76.0			F	07/30/2003	Info has been received from a registered nurse concerning a 76 year old female pt with multiple allergies who on 10/10/2002 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent (Lot #643249/0358M). Concomitant vaccination included a dose of influenza virus vaccine in the right arm. Post vaccination the pt developed a swollen left arm from her elbow to her shoulder, with 3 inch swollen diameter, itchy, red. Subsequently, the pt was treated with methylprednisolone sodium succinate benzyl alcohol (SOLU-MEDROL). Additional info has been requested.				Y					U	10/10/2002	10/10/2002	0	UNK	OTH	OTH			Multiple allergies		WAES0210USA02431	1						1	Injection site erythema; Injection site oedema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0358M~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207183	08/05/2003					U	07/30/2003	Info has been received from a pharmacist concerning a pt who on approximately 10/21/2002 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent. Concomitant vaccination included a dose of influenza virus vaccine in the right arm. Subsequently, the pt developed a high fever and swelling of the left arm. Unspecified medical attention was sought. Additional info has been requested.				Y					U	10/21/2002	10/21/2002	0	UNK	OTH	OTH			UNK		WAES0210USA02563	1						1	Injection site oedema; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207187	08/05/2003	CT	73.0	73		F	07/30/2003	Info has been received from a registered nurse concerning a 73 year old female with severe asthma, allergies to tetanus and prochlorperazine (COMPAZINE) and no illness at the time of vaccination who on 10/15/2002 was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent (lot 64279/0111M) IM in the right deltoid. On 10/15/2002, the pt was concomitantly vaccinated with the 3rd dose of influenza virus vaccine (FLUZONE) (lot U0881AA). On 10/15/2002, the pt developed a reddened, swollen area 3 times size of silver dollar at the site of injection. The area was hot to the touch. The arm was extremely sore and difficult to move. Ice was applied and the pt was given acetaminophen (TYLENOL) for the pain. On 10/17/2002, the symptoms became worse. The pt was treated with methylprednisolone (MEDROL). The pt had a reaction to the methylprednisolone, and therapy with methylprednisolone was discontinued on 10/20/2002. The pt's symptoms were better and resolved on 10/21/2002. The nurse also reported that a pt developed cellulitis, flushing, pyrexia, headache, injection site erythema, injection site inflammation, movement disorder, and nausea (WAES #0210USA02344) and another pt developed injection site erythema and inflammation (WAES #0210USA02662) post vaccination with pneumococcal vaccine 23 polyvalent. No additional info is expected.				Y					Y	10/15/2002	10/15/2002	0	UNK	PVT	PVT			Asthma, drug hypersensitivity, hypersensitivity		WAES0210USA02661	1						1	Hypokinesia; Injection site erythema; Injection site oedema; Injection site warmth; Pain	FLU3~SANOFI PASTEUR~~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0111M~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207188	08/05/2003	CT	73.0	73		F	07/30/2003	Info has been received from a registered nurse concerning a 73 year old female with allergies to penicillin and sulfa and was noted to be healthy at the time of vaccination who on 10/23/2002 was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent (lot 642749/0111M) IM in the right deltoid. On 10/22/2002, the pt was concomitantly vaccinated with a 7th dose of influenza virus vaccine (FLUZONE) IM in the left deltoid (lot U0881AA). On 10/23/2002, the pt developed a large reddened area at the injection site. The area was warm to the touch. The pt had a body temperature measurement of 98.2. Ice was applied and the pt was given acetaminophen (TYLENOL) as needed and methylprednisolone (MEDROL) as directed. On 10/25/2002, the pt was contacted and was improving. The pt was to continue methylprednisolone as directed. Subsequently, the pt recovered. The nurse also reported that a pt developed cellulitis, flushing, pyrexia, headache, injection site erythema, injection site inflammation, movement disorder and nausea (WAES #0210USA02344) and another pt developed injection site erythema, inflammation, swelling, pain in limb and drug hypersensitivity (WAES #0210USA02661) post vaccination with pneumococcal vaccine 23 polyvalent. No additional info is expected.				Y					Y	10/22/2002	10/23/2002	1	Body temp 10/23/02 98.2	UNK	PVT			Drug hypersensitivity; penicillin allergy		WAES0210USA02662	1						1	Feeling hot; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U0881AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0111M~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207189	08/05/2003	CT				M	07/30/2003	Info has been received from an office manager concerning a male pt who was vaccinated in his left arm with a dose of pneumococcal vaccine 23 polyvalent. Concomitant vaccination included a dose of influenza virus vaccine in the right arm. Post vaccination the pt developed swelling and difficulty lifting his left arm. The reporter indicated that a pt was treated with antibiotics, but did not specify if it was this pt or a second pt (WAES #0210USA02466) that experienced an adverse event post pneumococcal vaccine 23 polyvalent vaccination. Unspecified medical attention was sought. Additional info has been requested.				Y					U				UNK	OTH	OTH			UNK		WAES0210USA02676	1						1	Hypokinesia; Oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207192	08/05/2003	IN				M	07/30/2003	Info has been received from a male physician who on 10/25/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 642719/0376M). On 10/25/2002, the pt was concomitantly vaccinated with a dose of influenza virus vaccine in the opposite arm. Approx 24 hours post vaccination on approx 10/26/2002, the physician reported that his arm was sore and tender. At 36 hours post vaccination, he had a red, triangular, raised area at the site of the injection. He also developed chills and malaise. On 10/28/2002, he was beginning to feel more normal. He took acetaminophen for the symptoms. Additional info is not expected.									N	10/25/2002	10/26/2002	1	UNK	OTH	OTH			UNK		WAES0210USA02718	1						1	Chills; Injection site erythema; Injection site swelling; Malaise; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0376M~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0207196	08/05/2003	OR	78.0			F	07/30/2003	Info has been received from a registered nurse concerning a 78 year old female who on 10/24/2002 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot #643504/0735M).  That same day, the pt also received an influenza virus vaccine. In October 2002, the pt experienced swelling and developed tenderness in the injected arm. The pt was diagnosed with right shoulder and arm cellulitis and was treated with cephalexin (KEFLEX). As of 10/29/2002, the nurse reported that the pt was better. The nurse also provided info regarding other pts' experiences (WAES #0211USA00085, 0211USA00086 and 0211USA00087). The pt sought unspecified medical attention. Additional info has been requested.				Y					N	10/24/2002	10/26/2002	2	UNK	PVT	OTH			UNK		WAES0210USA02837	1						1	Cellulitis; Injection site oedema; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0735M~1~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207214	08/05/2003		42.0	42		F	07/30/2003	Information has been received from a registered pharmacist concerning a 42 year old female with no known allergies who on 10/29/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot # 643782/0675M). Concomitant therapy that day included a dose of influenza vaccine. On 10/30/02 the patient developed a 6 inch induration, tingling in the arm and difficulty using the arm. The patient sought unspecified medical attention. Additional information has been requested.				Y					U	10/29/2002	10/30/2002	1	UNK	OTH	OTH			UNK		WAES0211USA00189	1						1	Injection site induration; Joint range of motion decreased; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0675M~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207215	08/05/2003		72.0	72		F	07/30/2003	Information has been received from a registered nurse concerning a female adult patient with a ciprofloxacin hydrochloride allergy and no other past medical history who on 10/30/02 was vaccinated with pneumococcal vaccine 23 polyvalent (lot # 643784/0676M). Concomitant therapy that day included a flu vaccine and estrogens, conjugated. On 11/1/02 the patient developed redness and erythema area on her right arm which measured 4 inches. The patient was treated with diphenhydramine hydrochloride and warm compresses. The patient sought unspecified medical attention. Additional information has been requested.				Y					U	10/30/2002	11/01/2002	2		OTH	OTH	Premarin		Drug Hypersensitivity		WAES0211USA00197	1						1	Injection site erythema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0676M~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207219	08/05/2003	FL	71.0	71		F	07/30/2003	Information has been received from a physician and a woman in a physician's office concerning a 71 year old white female with hypertension, a seizure disorder and allergies to carbamazepine, phenytoin, and cefazolin sodium who on 10/25/02 (previously reported as 10/24/02) was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot # 642750/0210M). Concomitant therapy included phenobarbital, metoprolol tartrate and possibly influenza virus vaccine. On 10/25/02, the patient presented to a physician with right arm swelling (previously reported as swollen arm), chills, fever, joint pain, redness in her hand and heat from her shoulder down to her hand. Subsequently, the patient recovered from the right arm swelling, joint pain, redness in her hand and heat from her shoulder down to her hand. It was noted that the patient was vaccinated somewhere else and then presented to the reporting physician's office. The patient sought unspecified medical attention. Additional information is not expected.				Y					Y	10/25/2002	10/25/2002	0	UNK	OTH	OTH	Lopressor; Phenobarbital		Convulsion; Drug hypersensitivity; Hypertension		WAES0211USA00321	1						1	Arthralgia; Chills; Erythema; Feeling hot; Injection site swelling; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0210M~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207221	08/05/2003	MI	74.0	74		M	07/30/2003	Information has been received from a 74 year old white male with no known allergies and an LPN. The patient was vaccinated with the first dose of pneumococcal vaccine 23 polyvalent on 10/31/95 and the second dose on 10/22/02 SQ in the right arm (lot # 643249/0358M). On 10/22/02 the patient was also vaccinated with influenza vaccine (FLUZONE) IM in the left arm. Concomitant therapy included simvastatin, diltiazem hydrochloride, isosorbide, atenolol, omeprazole, amlodipine besylate, aspirin, vitamin E, fluticasone propionate, and imipramine. On approximately 10/22/02 the patient developed redness in his arm from the shoulder to the elbow and fluid retention and pain in his arm. Subsequently, the patient went to his physician and received a steroid shot. The patient's reaction lasted for 2 days. No further information is expected.				Y					Y	10/22/2002	10/22/2002	0	UNK	PVT	PVT	Norvasc; Aspirin; Atenolol; Diltiazem hydrochloride; Flonase; Imipramine; Isosorbide; Prilosec; Zocor; Vitamin E		UNK		WAES0211USA00518	1						1	Erythema; Fluid retention; Pain	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0358M~2~SC~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207225	08/05/2003		20.0			F	07/30/2003	Info has been received from a registered nurse in a clinic concerning an approx 20 year old female with no known drug allergies and asthma who on 11/05/2002 was vaccinated with pneumococcal vaccine 23 polyvalent. That same day medication included a dose of the influenza virus vaccine in the opposing arm. Subsequently the pt developed a small number of reddened welts that were approx 10 cm in diameter and were hot to touch. The pt sought unspecified medical attention. Additional info has been requested.				Y					U	11/05/2002			UNK	OTH	OTH			Asthma		WAES0211USA00815	1						1	Injection site warmth; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207230	08/05/2003	NY	56.0	56		F	07/30/2003	Info has been received from a registered nurse concerning a 56-year-old female registered nurse with arthritis and environmental allergies who on 10/29/2002, in the AM, was vaccinated with the 1st dose of pneumococcal vaccine 23 polyvalent (lot #641532/1353L) (also reported as Pnu-immune) administered in the left deltoid. There was no illness at the time of vaccination. On that same date, in the AM, the pt was also vaccinated with a dose of influenza virus vaccine (FLUSHIELD) (lot #4020025) administered in the right deltoid. Concomitant therapy included rofecoxib (MSD) (12.5 mg daily) and montelukast sodium (MSD) (100 mg daily). On 10/29/2002, in the evening, the pt developed redness, a lot of erythema of the whole upper arm, a lot of warmth of the whole upper arm, tenderness and significant swelling under the left arm and axilla. The pt was unable to participate in exercise classes. The pt sought unspecified medical attention. Within 72 hours, the pt's symptoms resolved and as of 11/01/2002 she had recovered. There were no diagnostic tests or laboratory results. Additional info is not expected.				Y					Y	10/29/2002	10/29/2002	0	NONE	OTH	PUB	Singulair, Vioxx		Arthritis; environmental allergy		WAES0211USA00917	1						1	Feeling hot; Injection site erythema; Injection site oedema; Pain	FLU3~PFIZER\WYETH~~UNK~~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~1353L~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207234	08/05/2003					M	07/30/2003	Info has been received from a Pharm D concerning a male who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot number not reported). Concomitant vaccination on the same day included a dose of influenza virus vaccine in the opposite arm. Subsequently the pt developed itching, swelling and redness on the underside of his arm that was injected with pneumococcal vaccine 23 polyvalent. The outcome of the pt's itching, swelling and redness was unknown. The Pharm D reported that the pt sought unspecified medical attention. A product quality complaint was not involved. Additional info has been requested.				Y					U				UNK	OTH	OTH			UNK		WAES0211USA00943	1						1	Injection site erythema; Injection site oedema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207238	08/05/2003	VA	59.0	59		F	07/30/2003	Info has been received from a health care professional concerning a disabled 59 year old female pt with no known drug allergies who on 11/11/2002 was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent intramuscularly in the bicep (lot #643785/0872M). Concomitant vaccination the same day included a dose of influenza virus vaccine. After administration, the pt went to the ER because her arm was swollen and painful. She was treated with diphenhydramine hydrochloride (BENADRYL) and unspecified steroids. Follow-up info from a health care professional reported that on 11/11/2002 at 6:30 PM the pt called to report she had developed a rash with no itching and swelling the size of an egg that was extremely tender to the touch. She went to the ER where her arm was extremely painful with burning to the shoulder. It was also reported that this arm pain caused her blood pressure to go up. Subsequently, the pt recovered. It was also reported that a 62 year old male was vaccinated with a dose of pneumococcal vaccine 23 polyvalent and extremely sore and painful arm. (WAES #0211USA01581). No further info is expected.				Y					Y	11/11/2002	11/11/2002	0	UNK	PVT	PVT			Disability		WAES0211USA01408	1						1	Injection site oedema; Pain; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0872M~2~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207240	08/05/2003		44.0	44		F	07/30/2003	Info has been received from a registered nurse concerning a 44 year old female who on 10/16/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #641115/1159L). Concomitant therapy that day included a dose of an influenza virus vaccine and interferon beta-la (AVONEX). Subsequently, the pt developed severe swelling above elbow, and entire posterior left arm was red and hot. The pt was also reportedly short of breath, light headed. The reporter considered this as an allergic reaction to pneumococcal vaccine 23 polyvalent. The pt sought medical attention and was treated with cetirizine (Zyrtec). Additional info has been requested.				Y					U	10/16/2002	10/16/2002	0	UNK	OTH	OTH	AVONEX		UNK		WAES0211USA01412	1						1	Dizziness; Dyspnoea; Injection site erythema; Injection site oedema; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1159L~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207241	08/05/2003					U	07/30/2003	Info has been received on 11/13/2002 from a physician's assistant concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent, in the arm. Concomitant therapy that day included a dose of influenza virus vaccine, in the opposite arm. Subsequently the pt developed a site reaction characterized by pain, swelling and redness. It was described as an Arthrus reaction with a fever of 101 to 102 degrees F. The pt sought unspecified medical attention. Additional info has been requested.				Y					U				Body temp 101 F.	OTH	OTH			UNK		WAES0211USA01423	1						1	Injection site erythema; Injection site oedema; Pain; Pyrexia; Type III immune complex mediated reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207254	08/05/2003					M	07/30/2003	Information has been received from a pharmacist concerning a male patient who was vaccinated in the arm with a dose of pneumococcal vaccine 23 polyvalent.  Concomitant vaccination on the same day included a dose of influenza virus vaccine in the other arm.  Subsequently, the patient developed an injection site reaction that included itching, swelling and redness on the underside of the arm that was injected with pneumococcal vaccine 23 polyvalent.  Additional information has been requested.									U					OTH	OTH	UNK	UNK	UNK		0211USA01830	1						1	Injection site erythema; Injection site oedema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0207255	08/05/2003	GA	22.0	22		F	07/30/2003	Information has been received from a medical assistant concerning a 22 year old female patient with asthma, which is currently under control, who on 11/13/2002 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M) in the left deltoid.  Concomitant vaccine therapy included a dose of influenza virus vaccine.  There was no illness at the time of vaccination.  Concomitant medication included montelukast sodium (MSD), fluticasone propionate (+) salmetrol xinafoate (ADVAIR), loratadine (CLARITIN), and albuterol.  On 11/14/2002 the patient presented to the physician;s office with a hot, swollen, painful rash at the injection site with a red and tender area that measured 1 3/4cm in diameter.  On 11/14/2002 a CBC revealed an elevated WBC count of 12.9 and the patient was diagnosed with cellulitis of the left deltoid.  On 11/15/2002, a raised red lesion measuring 2.5cm x 2.5cm was noted and the WBC was 16.5.  See laboratory section for additional test results.  It was noted that the patient received a second opinion about the reaction.  Additinoal information has been requested.				Y					U	11/13/2002	11/14/2002	1	Diagnostic laboratory: 0.0-1.8 MID-includes rare cells and precursor white cells; Diagnostic laborabory: 0.7%M-MID; Blood granulocyte count: 8.5%G 2.0-8.6; Blood granulocyte count: 12.7%G; Hemoglobin: 13.9g/dl, 12.0-18.0;  Mean corpuscular: 28.8; Mean corpuscular: 34.3; Mean corpuscular volume: 83.9 fl; Hematocrit: 41.0%- 37.0-51.0; WBC count: 16.5 K/ul-elevated; WBC count: 12.9- 4.1-10.9 - elevated; RDW: 12.7%; RDW: 12.6%- 11.5-14.5; RBCC: 4.52 M/ul; RBCC: 4.75M/ul - 4.20-6.30; Mean Platelet volume: 8.3fl; Mean Platelet volume: 9.2fl- 0.0-99.8; Hematocrit: 37.9%; Mean corpuscular volume: 86.4fl - 80.0-97.0; Mean corpuscular: 31.0-36.0; Mean corpuscular: 26.0-32.0; Lymphocyte count: 3.3%/l-0.6-4.1; Lymphocyte count: 3.1%L; Platelet count: 252k/ul- 140-440; Platelet count: 274K/ul;	PVT	PVT	albuterol, advair, claritin, singulair		Asthma NOS		0211usa01889	1						1	Cellulitis; Feeling hot; Injection site erythema; Injection site oedema; Injection site pain; Injection site rash; Laboratory test abnormal	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0445m~1~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207259	08/05/2003	IL	69.0	68		M	07/30/2003	Information has been received from a registered nurse concerning a 69 year old male patient, who on 11/18/2002 was vaccinated in the right arm with a dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M).  Concomitant vaccination included a dose of influenza virus vaccine in the left arm.  On 11/20/2002, the patient called the doctor's office reporting that he had developed a rash from his elbow to his shoulder on his right arm.  No other symptoms were reported.  The patient was expected to be seen at the doctor's office.  Subsequently, the patient fully recovered.  The reporter indicated that two other patients (WAES #'s 0212USA01969 & 0212USA01970) received pneumococcal vaccine 23 polyvalent from the same lot and also experienced worse than usual local reactions.  The reporter also noted that This office has given [pneumococcal vaccine 23 polyvalent] for over 10 years and we have never had the type of reactions that these 3 (and subsequent) patients experienced (WAES # 0303USA00344).  The reporter stated that she was uncomfortable using the rest of the vial or other vials from the same lot.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additional information is not expected.				Y					Y	11/18/2002	11/20/2002	2	UNK	OTH	OTH	UNK	UNK	UNK		0211USA01991	1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0445M~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207262	08/05/2003	AL				F	07/30/2003	Information has been received from a health professional concerning a female patient who in approximately October 2002, was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M); additional therapy included a dose of influenza virus vaccine flu vaccine, which was given in the opposite arm.  The reporter indicated the patient had a reaction to the pneumococcal vaccine 23 polyvalent.  In approximately October 2002, the patient developed soreness at the injection site.  The pain was described as a 4 on the pain scale and lasted 48-72 hours.  The reporter requested a lot check.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Unspecified medical attention was sought.  Additional information has been requested.				Y					U	10/01/2002	10/01/2002	0	UNK	OTH	OTH	UNK	UNK	UNK		0211USA02240	1						1	Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0445M~1~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207263	08/05/2003	AL				F	07/30/2003	Information has been received from a health professional concerning a female patient who was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M).  Additional therapy given at the same time, in the opposite arm included a dose of influenza virus vaccine, flu vaccine.  The reporter indicated the patient had a reaction to the pneumococcal vaccine 23 polyvalent, which was described as a silver dollar size raised red area at the injection site, and injection site soreness, rated 4 on a pain scale.  It was noted the raised red area lasted 72 hours.  The reporter requested a lot check.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Unspecified medical attention was sought.  Additional information has been requested.  The health professional mentioned 13 other patients who also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES #'s: 0210USA01524, 0210USA01734, 0211USA02240, 0211USA02242, 0211USA02243, 0211USA02244, 0211USA02245, 0211USA02246, 0211USA02247, 0211USA02248, 0211USA02249, 0211USA02250, 0211USA02251).				Y					Y	10/01/2002	10/01/2002	0	UNK	OTH	OTH	UNK	UNK	UNK		0211USA02241	1						1	Injection site pain; Rash erythematous	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0445m~1~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207264	08/05/2003	AL				F	07/30/2003	Information has been received from a health professional concerning a female patient who in approximately October 2002 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M).  Additional therapy given at the same time, in the opposite arm included a dose of influenza virus vaccine, flu vaccine.  The reporter indicated the patient had a reaction to the pneumococcal vaccine 23 polyvalent.  In approximately October 2002 the patient developed redness with swelling to inside of arm, joint aches, fever-101.2, pain rated 5 on a scale of 1-10 and was unable to raise her arm.  The reporter requested a lot check.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Unspecified medical attention was sought.  Additional information has been requested.  The health professional mentioned 13 other patient's who also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES#'s:  0210USA01524, 0210USA01734, 0211USA02240, 0211USA02241, 0211USA02243, 0211USA02244, 0211USA02245, 0211USA02246, 0211USA02247, 0211USA02248, 0211USA02249, 0211USA02250, 0211USA02251).				Y					U	10/01/2002	10/01/2002	0		OTH	OTH	UNK	UNK	UNK		0211USA02242	1						1	Erythema; Hypokinesia; Oedema; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0445M~1~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207265	08/05/2003	AL				U	07/30/2003	Information has been received from a health professional concerning a patient who in approximately October 2002 was vaccinated in the left arm with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M).  Additional therapy given at the same time, in the opposite arm included influenza virus vaccine, flu vaccine.  The reporter indicated the patient had a reaction to pneumococcal vaccine 23 polyvalent.  In approximately October 2002 the patient developed severe pain in the left arm, and could barely lift the arm.  The reporter requested a lot check.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Unspecified medical attention was sought.  Additional information has been requested.				Y					U	10/01/2002	10/01/2002	0	UNK	OTH	OTH	UNK	UNK	UNK		0211USA02243	1						1	Hypokinesia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0445m~1~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207266	08/05/2003	AL				U	07/30/2003	Info has been received from a health professional concerning a pt who in approx Oct 2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot 3643251/0445M). Additional therapy given at the same time, in the opposite arm included influenza virus vaccine, flu vaccine. The reporter indicated the pt had a reaction to the pneumococcal vaccine 23 polyvalent. Subsequently, in approx Oct 2002, the pt developed soreness in the arm, and it was warm to touch 6 days after the injection. It was also noted, the pt had enlarged axillary lymph node with soreness. The reporter requested a lot check. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Unspecified medical attention was sought. Additional info has been requested.				Y					U	10/01/2002	10/08/2002	7	UNK	OTH	OTH			UNK		WAES0211USA02244	1						1	Feeling hot; Lymphadenopathy; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0445M~1~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207267	08/05/2003	AL				F	07/30/2003	Info has been received from a health professional concerning a female pt who on 10/09/2002 was vaccinated in the left arm with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). Additional therapy given on 10/09/2002 in the opposite arm included influenza virus vaccine, flu vaccine. The reporter indicated the pt had a reaction to the pneumococcal vaccine 23 polyvalent. Subsequently on 10/10/2002 (also reported as the next day) the pt developed soreness in the left arm at the injection site, on 10/15/2002 she developed a sore throat. On 10/17/2002, she called sick with a sore throat, lethargy and head cold. It was noted the pt had not had a cold or flu in 5 years. The reporter requested a lot check. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Unspecified medical attention was sought. Additional info has been requested.				Y					U	10/09/2002	10/10/2002	1	UNK	OTH	OTH			UNK		WAES0211USA02245	1						1	Lethargy; Pain; Pharyngolaryngeal pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0445M~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207268	08/05/2003	AL				F	07/30/2003	Info has been received from a health professional concerning a female pt who on 10/09/2002, was vaccinated in the arm with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). Additional therapy on 10/09/2002 given in the opposite arm included a dose of influenza virus vaccine, flu vaccine. The reporter indicated the pt had a reaction to pneumococcal vaccine 23 polyvalent . Subsequently on approx 10/09/2002 the pt developed severe pain in arm and under arm, and she was unable to lift her arm for 3 days (approx 10/12/2002). It was noted, the arm was warm and a little swollen, but felt better by Tuesday, 10/14/2002. It was noted the pt rated the pain 8 on a pain scale, and took ibuprofen (ADVIL) for the pain. The reporter requested a lot check. The records of pain testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested. The health professional 13 other pts who also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES #0210USA01524, 0210USA01734, 0211USA02240, 0211USA02241, 021USA02242, 0211USA02243, 0211USA02244, 0211USA02245, 0211USA02247, 0211USA02248, 0211USA02249, 0211USA02250, and 0211 USA02251.				Y					Y	10/09/2002	10/09/2002	0	UNK	OTH	OTH			UNK		WAES0211USA02246	1						1	Feeling hot; Hypokinesia; Injection site oedema; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0445M~1~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207269	08/05/2003	AL				F	07/30/2003	Info has been received from a health professional concerning a female pt who in approximately Oct 2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). Additional therapy given at the same time, in the opposite arm, included a dose of influenza virus vaccine, flu vaccine. Subsequently, in approx Oct 2002 and pt developed chills that night after receiving the vaccine, and small amount of soreness in both arms. The reporter requested a lot check. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Unspecified medical attention was sought. Additional info has been requested.				Y					U	10/01/2002	10/01/2002	0	UNK	OTH	OTH			UNK		WAES0211USA02247	1						1	Chills; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0445M~1~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207270	08/05/2003	AL				F	07/30/2003	Info has been received from a health professional concerning a female pt, who in approx Oct 2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot 3643251/0445M). Additional therapy given at the same time, in the opposite arm included a dose of influenza vaccine, flu vaccine. The reporter indicated the pt had a reaction to the pneumococcal vaccine 23 polyvalent. Subsequently in approx Oct 2002, the pt developed severe pain, very swollen armpit with throbbing, sore to the bone and she could not raise her hand. It was noted the soreness lasted for 2 days. The reporter requested a lot check. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Unspecified medical attention was sought. Additional info has been requested. The health professional mentioned 13 other pts who also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES #0210USA01524, 0210USA01734, 0211USA02240, 0211USA02241, 0211USA02242, 0211USA02243, 0211USA02244, 0211USA02245, 0211USA02246, 0211USA02247, 0211USA02249, 0211USA02250 and 0211USA02251).				Y					U	10/01/2002	10/01/2002	0	UNK	OTH	OTH			UNK		WAES0211USA02248	1						1	Hypokinesia; Oedema; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0445M~1~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207271	08/05/2003	AL				F	07/30/2003	Info has been received from a health professional concerning a female pt who was vaccinated with a 1st dose pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). Additional therapy given at the same time in the opposite arm, included a dose of influenza virus vaccine, flu vaccine. Subsequently in approx Oct 2002, the pt developed a sore arm, and pain under right armpit. It was noted she could not lay on that side for a couple of days. The reporter requested a lot check. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Unspecified medical attention was sought. Additional info has been requested.				Y					U	10/01/2002	10/01/2002	0	UNK	OTH	OTH			UNK		WAES0211USA02249	1						1	Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0445M~1~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207272	08/05/2003	AL				F	07/30/2003	Info has been received from a health professional concerning a female pt who in approx Oct 2002 was vaccinated in the left arm with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). Additional therapy given at the same time in the opposite arm included a dose of influenza virus vaccine, flu vaccine. Subsequently in approx Octo 2002, the pt developed soreness in her left arm, and she couldn't raise her arm. It was noted she took antiinflammatories for the pain. The soreness and inability to raise her left arm lasted for 2 days. The reporter requested a lot check. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Unspecified medical attention was sought. Additional info has been requested. The health professional mentioned 13 other patients who also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES #0210USA01524, 0210USA01734, 0211USA02240, 0211USA02241, 0211USA02242, 0211USA02243, 0211USA02244, 0211USA02245, 0211USA02246, 0211USA02247, 0211USA02248, 0211USA02249 and 0211USA02251).				Y					Y	10/01/2002	10/01/2002	0	UNK	OTH	OTH			UNK		WAES0211USA02250	1						1	Hypokinesia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|RUB~MERCK & CO. INC.~0445M~1~~LA~RUBELLA (MERUVAX II)~1	USA	Emergency room visit	Influenza
0207273	08/05/2003	AL				F	07/30/2003	Info has been received from a health professional concerning a female pt who in approx Oct 2002, was vaccinated in the right arm with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). The reporter indicated the pt had a reaction to pneumococcal vaccine 23 polyvalent. Subsequently in approx Oct 2002, the pt developed right arm soreness and mild edema. The reporter requested a lot check. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Unspecified medical attention was sought. Additional info has been requested.				Y					U	10/01/2002	10/01/2002	0	UNK	OTH	OTH			UNK		WAES0211USA02251	1						1	Injection site oedema; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0445~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207274	08/05/2003					F	07/30/2003	Info has been received from a Pharm. D. concerning a female who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot number not reported). On the same day, the pt was vaccinated in the opposite arm with a dose of concomitant therapy influenza virus vaccine. Subsequently the pt developed itching, swelling and redness on the underside of her arm that was injected with pneumococcal vaccine 23 polyvalent. The outcome of the pt's itching, swelling and redness was unknown. The Pharm. D. reported that the pt sought unspecified medical attention. Additional info has been requested.				Y					U				UNK	OTH	OTH			UNK		WAES0211USA02269	1						1	Injection site erythema; Injection site oedema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207294	08/05/2003	MD	13.0	13		M	07/30/2003	Information has been received from a physician concerning a 13 year old male pt with a history of asthma and pharyngitis and epistaxis at the time of vaccination who on 11/21/02 was vaccinated SC in the right arm with a first dose of pneumococcal vaccine 23 polyvalent (643503/0541M). Concomitant therapy on 11/21/02 included a first dose of influenza virus vaccine (Fluvirin) IM in the left arm (E31862GA). On 11/22/02 the pt developed cellulitis of the right arm (at the injection site) for two days. The pt was treated with antibiotics. It was noted that the pt recovered on 11/24/02. It was also reported that two female patients developed cellulitis at the injection site (WAES0211USA02439) and one female pt (WAES0302USA00556) developed cellulitis in the left arm at the injection site that resolved in two days. The symptoms of two of the patients cleared up without event. Two patients were seen over the weekend within a day or two of injection and at the time of this report follow up had not occurred. It was reported that the pt had recovered. Additional info has been requested.									Y	11/21/2002	11/22/2002	1	UNK	PVT	PVT			Epistaxis; pharyngitis; asthma  NOS		WAES0212USA00380	1						1	Cellulitis	FLU3~EVANS VACCINES~E31862GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0541M~1~SC~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0207300	08/05/2003	MI	29.0	29		M	07/30/2003	Info has been received from a licensed practical nurse concerning a 29-year-old male volunteer firefighter with no known drug allergies and no past medical history who on 12/02/2002 at 7:00 PM was vaccinated IM in the deltoid with a first dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). Concomitant therapy that day at 7:00 PM included a dose of influenza virus vaccine (FLUZONE) (Batch #U0925AA) given IM in the deltoid. There was no illness at the time of vaccination. No adverse events following prior vaccinations for the pt or his siblings were reported. Two hours after receiving the vaccination, the pt was called out on a major structure fire and spent the next 20 hours at the fire scene engaged at times in heavy physical labor. On 12/03/2002 at 9:00 PM the pt developed induration and redness from his elbow to his shoulder, along with swelling, hot to touch, and pain. He did not require medical care as a result of this. The reporter indicated that she suspects the heavy physical activity in the fire played a major role in their reactions. It was noted that the pt recovered on 12/09/2002.The reporter indicated that 9 other pts received a dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M) and developed induration at the injection site (WAES #0212USA00729, 0212USA01192, 0212USA01193, 0304USA02075, 0304USA02076, 0304USA02077, 0304USA02078, 0304USA02079 and 0304USA02081). No further info is expected.									Y	12/02/2002	12/03/2002	1	Body height measurement (12/02?/02) 72 inches. Body weight measurement (12/02?/02) 140 pounds.	OTH	PVT			NONE		WAES0212USA00825	1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site warmth; Pain	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0445M~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0207303	08/05/2003	NY	41.0	41		M	07/30/2003	Info has been received from a physician concerning a 41 year old male pt with no known allergies and a medical history of non-hodgkins lymphoma who on 12/05/2002 at 14:00 was vaccinated intramuscularly in the left deltoid area with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #642722/0165M). On 12/05/2002, the pt was concomitantly vaccinated with influenza virus vaccine. On 12/05/2002 at 5:00 PM. 3 hours post vaccination, the pt developed erythema, tenderness and edema at the injection site (left deltoid area) of the pneumococcal vaccine 23 polyvalent. Erythema and edema progressed to the elbow over the next 48 hours. There was no relevant diagnostic laboratory data. The pt was treated in the ER with antibiotics (unspecified therapy) for possible cellulitis and diphenhydramine HCl (Benadryl) and steroids (unspecified therapy) for an allergic reaction. There were no sensory or muscle damage reported and the pt did not develop fever or chills at any time. Subsequently, the pt recovered. No further info is expected.				Y					Y	12/05/2002	12/05/2002	0	Body temp (12/05?02) afebrile.	PVT	PVT			Non-Hodgkin's lymphoma		WAES0212USA00844	1						1	Injection site erythema; Injection site oedema; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0165M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207305	08/05/2003	PA	62.0	62		F	07/30/2003	Info has been received from a registered nurse concerning a 62-year-old female pt with dilated cardiomyopathy and no known allergies and no acute process who on 12/09/2002, also reported as 12/06/2002, was vaccinated IM in the left arm with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #644104/0873M). Concomitant therapy that day, also reported as 12/06/2002, included a 2nd dose of influenza virus vaccine (FLUSHIELD) (Lot #400-0011) given IM in the right arm. There were no chronic medications. On 12/10/2002, also reported as 12/07/2002, the pt developed a local reaction described as a very painful and swollen arm. The pt was seen at an ER where her HCP saw her and recommended warm compresses. It was reported that the pt was scheduled to be seen 12/10/2002, but has not been heard back from since 12/07/2002. Follow up info received from a registered nurse indicated that on 12/10/2002, the pt developed redness and edema below the injection site. There was no acute distress. It was reported that the MD impression was a chemical reaction which was due to either irritation, questionable allergic reaction, or TMT. Initially in the ER the pt was given diphenhydramine hydrochloride (BENADRYL) and ice. The pt was instructed to continue with cool compresses for 24 hours, then switch to warm compresses, and to elevate her arm. She was prescribed antihistamines and antiinflammatories prn, and instructed to follow up with her PCP. The report indicated that the pt recovered. No further info is expected.				Y					Y	12/09/2002	12/10/2002	1	Blood pressure (12/10/02) 120/6. Body temp: 97.6. Body weight measurement: 130 pounds. Total heartbeat count: 76. Vital sign: 16 respirations.	PVT	PVT			Dilated cardiomyopathy		WAES0212USA00996	1						1	Injection site oedema; Pain	FLU3~PFIZER\WYETH~~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0873M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207308	08/05/2003	MI	46.0	46		M	07/30/2003	Info has been received from a licensed practical nurse concerning her 46-year-old husband who is a machinist and volunteer firefighter and who has allergies to penicillin (unspecified), dustmites and some trees and weeds who on 12/02/2002 at 7:00 PM was vaccinated IM in the deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). There was no illness at the time of vaccination. No adverse events following prior vaccinations for the pt or his siblings were reported. Concomitant therapy that day at 7:00 PM included a 1x every 10 year dose of influenza virus vaccine (FLUZONE) (Batch #U0925AA) given IM in the opposite deltoid. Additional concomitant medications included cetirizine hydrochloride (+) pseudoephedrine hydrochloride (ZYRTEC-D) given q12h and budesonide (RHINECORT) nasal spray. Subsequently, the pt developed redness and induration from his elbow to his shoulder. It was reported that symptoms resolved without treatment in a couple of days. Follow up info received from a licensed practical nurse indicated that on 12/03/2002 at 9:00 PM the pt developed pain, redness and swelling, and it was noted that the area from the shoulder to the elbow was hot to the touch. No medical care was required as a result of the reaction. It was noted that 2 hours after receiving the vaccination, the pt was called out on a major structure fire and spent the next 20 hours at the fire scene engaged at times in heavy physical labor. The reporter indicated that she suspects that this activity played a major role in their reactions. It was noted that on 12/09/2002 the pt recovered. No diagnostic tests or laboratory data were reported. The reporter indicated that 9 other pt received a dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445) and developed induration at the injection site (WAES #0212USA00729, 0212USA00825, 0212USA01193, 0304USA02075, 0304USA02076, 0304USA02077, 0304USA02078, 0304USA02079 and 0304USA02081). No further info is expected.									Y	12/02/2002	12/03/2002	1	Body height measurement (12/02?/02) 72 inches. Body weight measurement: 250 pounds.	OTH	PVT	Rhinocort, Zyrtec-D		Penicillin allergy		WAES0212USA01192	1						1	Injection site erythema; Injection site induration; Injection site warmth	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0445M~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0207309	08/05/2003	MI	14.0	14		M	07/30/2003	Info has been received from a licensed practical nurse concerning her 14-year-old son who is a student with allergies to sulfa, bee stings, grass, molds and trees who on 12/02/2002 at 7:00 PM was vaccinated IM in the deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). There was no illness at the time of vaccination. Concomitant therapy that day at 7:00 PM included a 1x every 5 year dose of influenza virus vaccine (FLUZONE) (Batch #U0925AA) given IM in the opposite deltoid. Additional concomitant medications included cetirizine hydrochloride (ZYRTEC) and an allergy injection for bees, grass, trees and mold. Subsequently, the pt developed redness and induration from his elbow to his shoulder. It was reported that symptoms resolved without treatment in a couple of days. Follow up info received from a licensed practical nurse indicated that on 12/03/2002 at 8:00 AM the pt developed pain, redness and swelling, and the area from the shoulder to the elbow was hot to the touch. No medical care was required as a result of the reaction. It was noted that on 12/09/2002 the pt recovered. There were no adverse events following prior vaccinations. The reporter indicated that 9 other pts received a dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M) and developed induration at the injection site (WAES #0212USA00729, 0212USA00825, 0212USA01192, 0304USA02075, 0304USA02076, 0304USA02077, 0304USA02078, 0304USA02079 and 0304USA02081). No further info is expected.									Y	12/02/2002	12/03/2002	1	Body height measurement (12/02?/02) 68 inches. Body weight measurement: 190 pounds.	OTH	PVT	Allergenic extract; Zyrtec		Bee sting; drug hypersensitivity; mycotic allergy		WAES0212USA01193	1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site warmth; Pain	FLU3~SANOFI PASTEUR~U0925AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0445M~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0207315	08/05/2003					F	07/30/2003	Info has been received from a pharmacist concerning a female pt who was vaccinated in the arm with a dose of pneumococcal vaccine 23 polyvalent. Vaccination on the following day included a dose of influenza virus vaccine in the other arm. Subsequently, the pt developed an injection site reaction that included itching, swelling and redness on the underside of the arm that was injected with pneumococcal vaccine 23 polyvalent. The pharmacist reported 2 other pts who had similar experiences following vaccination with pneumococcal vaccine 23 polyvalent (MSD) (WAES #0211USA01830 and 021USA01470). Additional info has been requested.									U				UNK	OTH	OTH			UNK		WAES0212USA01469	1						1	Erythema; Oedema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0207318	08/05/2003	NY	67.0	67		F	07/30/2003	Information has been received from a physician concerning a 67 year old female pt with a touch of insomnia, a history of a recent cold and no allergies who in October 2002, was vaccinated IM with a dose of pneumococcal vaccine 23 polyvalent (640744/0994L). Concomitant vaccine therapy included a dose of influenza virus vaccine (Fluzone). There was no illness at the time of vaccination. Concomitant therapy included alendronate sodium, Ceftin and azithromycin. Subsequently, the pt developed nausea that started 7-10 days after the injection and lasted for 30 days (previously reported as being present since right after the pt received the shot). The pt also had difficulty sleeping and had a cold. The physician feels as if the cold was unrelated to the shot but questioned if the injection could possibly cause the nausea. On 12/17/02, no intervention was reported. On 1/10/03, it was reported that the pt had a GI consult, unspecified blood tests and an MRI of the head, all of which were negative. Subsequently, on 12/23/02, the pt recovered. Additional info is not expected.				Y					Y	10/01/2002			Diagnostic lab-blood tests negative; doctor visit gastro intestinal consult; MRI negative (head)	PVT	PVT	Fosamax; azithromycin; Ceftin				WAES0212USA01617	1						1	Insomnia; Nasopharyngitis; Nausea	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0994L~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207319	08/05/2003	TX	67.0	67		M	07/30/2003	Information has been received from a RN concerning a 67 year old retired male with sinusitis and no prior medical history who on 12/16/02 at 11:45 was vaccinated SC in the right arm with a second dose of pneumococcal vaccine 23 polyvalent (643783/0709M). Concomitant vaccination on 12/16/02 included a dose of influenza virus vaccine in the left arm. The pt was reported as afebrile at the time of the vaccination. There were no other concomitant medications. On 12/17/02 at 10:00, the pt developed increased warmth, edema, and erythema in his right upper arm. The pt was seen in the physician's office with fever of 100.6 F and localized swelling and redness at the injection site. The pt had full ROM in his hands and fingers bilaterally. It was also noted that there was no SOB and no wheezing for 2-3 days post vaccination. The pt was treatted with Clarinex 5mg daily as needed. Subsequently the pt recovered. Additional info is not expected.				Y					Y	12/16/2002	12/17/2002	1	Body temp-100.6 F  12/17/02	PVT	PVT			Sinusitis NOS		WAES0212USA01619	1						1	Erythema; Feeling hot; Injection site erythema; Injection site oedema; Oedema peripheral; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0709M~2~SC~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207326	08/05/2003	CA	48.0	48		F	07/30/2003	Information has been received from a medical assistant concerning a 48 year old female housewife with no known drug allergies, and a viral infection at time of vaccination who on 10/15/02 at 10am was vaccinated SC in the right deltoid with a first dose of pneumococcal vaccine 23 polyvalent (643782/0675M). On 10/15/02 at 10:05am the pt was concomitantly vaccinated with a SC dose of influenza virus vaccine (Fluvirin) (E30132FA) and at 10:15am an IM dose of diphtheria toxoid/pertussis vaccine/teta (Acelluvax DTP) (U0521AA). Subsequently the pt developed a metallic taste in her mouth, which progressed to no taste and then became a sweet taste. The physician reported that the pt developed a virus of her trigeminal nerve which caused her metallic taste that was discussed with ENT physicians and was not associated with her vaccine. However, the pt stated that this metallic taste did occur after she received her influenza and pneumococcal shots. It was noted that the pt recovered. No further info is requested.				Y					Y	10/15/2002			UNK	PVT	PVT			UNK		WAES0212USA01789	1						1	Ageusia; Dysgeusia; Viral infection	DTAP~SANOFI PASTEUR~U0521AA~UNK~IM~~DTAP (TRIPEDIA)~1|FLU3~EVANS VACCINES~E30132FA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0675M~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207334	08/05/2003	IL	67.0	67		F	07/30/2003	Information has been received from a registered nurse concerning a 67 year old female patient, who on Nov 18, 2002 was vaccinated in the right arm with a dose of pneumococcal vaccine 23 polyvalent (lot#643251/045M). Concomitant vaccination included a dose of influenza virus vaccine in the left arm. On Nov 20,2002 the patient called the doctor's office reporting that she had developed a rash from her elbow to her shoulder on her right arm. No other symptoms were reported. The patient was expected to be seen at the doctor's office. Subsequently, the patient fully recovered. The reporter indicated that two other patients (WAES0212USA01991 and 0212USA01970) received pneumococcal vaccine 23 polyvalent from the same lot and also experienced worse than usual local reactions. The reporter also noted that This office has given (pneumococcal vaccine 23 polyvalent) for over 10 years and we have never had the type of reactions that these 3 (and subsequent) patients experienced (WAES0303USA00344). The reporter stated that she was uncomfortable using the rest of the vial or other vials from the same lot. The records of testing prior to release of this lot have been checked by compliance and found to be satisfactory. The lot complies with the standards of the center for evaluation and research and was released. Additional information is not expected.				Y					Y	11/18/2002	11/20/2002	2	UNK	OTH	OTH	UNK	UNK	UNK		WAES0212USA01969	1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0445M~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207353	08/05/2003	TX	72.0	72		F	07/30/2003	Information has been received from a 72 year old female patient with a drug allergy to penicillin and a history of open heart surgery who on approximately Dec 6, 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. The patient was concomitantly vaccinated with influenza virus vaccine. Subsequently the patient developed severe pain and immobility in her left arm where she received the pneumonia shot and it is almost better now. The physician treated her with celecoxib (Celebrex) for the pain, but it did not help. He switched her rofecoxib (MSD) and it helped her pain. No further information is expected.				Y					N	12/06/2002	12/06/2002	0	UNK	OTH	OTH			Open heart surgery, drug hypersensitivity		WAES0301USA01008	1						1	Joint range of motion decreased; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0207365	08/05/2003	MD	81.0	81		F	07/30/2003	Information has been received from a registered nurse concerning an 81 year old white female with allergies to penicillin and phenobarbital who on 10/30/2002 was vaccinated in the left arm with a second dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M).  Concomitant vaccination on 10/30/2002 given IM in the right arm included a dose of influenza virus vaccine (FLUVIRIN)(Lot # E32852GA).  It was reported that the patient had several previous doses of the latter vaccine.  The patient had gallstones at the time of vaccination.  On 10/30/2002 the patient developed cellulitis of the left arm.  The patient had pain, redness, itching and swelling in the injected arm.  She was given cephalexin (KEFLEX) 500mg one four times daily.  The symptoms subsided in a few days.  It was reported that the patient recovered on 11/02/2002.  It was also reported that one other patient received the same vaccine and developed a cellulitis-type reaction (WAES # 0301USA02553).  No further information is expected.				Y					Y	10/30/2002	10/30/2002	0	UNK	PVT	PVT	NONE	Cholelithiasis	Drug hypersensitivity		0301USA02039	1						1	Erythema; Oedema; Pain; Pruritus	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0445M~2~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207372	08/05/2003	PA	9.0	9		F	07/30/2003	Information has been received from a physician concerning a 9 year old female patient with a diagnosis of nephrotic syndrome and no known drug allergies who on Feb 3, 2003 was vaccinated in the left arm with a first dose of pneumococcal vaccine 23 polyvalent (lot# 644107/0955M). Concomitant vaccinations the same day included influenza virus vaccine (Flushield) in the right arm. Other concomitant medication included prednisone. There was no illness at the time of vaccination. In the am of Feb 4, 2003 the patient experienced intermittent numbness and tingling of both feet for one day. Unspecified medical attention was sought. It was unknown if intervention was required. Follow up information from the physician indicated that no treatment or evaluation was necessary and that spontaneous resolution occurred. There were no diagnostic tests or laboratory results. The patient recovered on Feb 4, 2003. No further information is expected.									Y	02/03/2003	02/04/2003	1	NONE	PVT	OTH	prednisone		nephrotic syndrome		WAES0302USA00514	1						1	Hypoaesthesia; Paraesthesia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0955M~1~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0207403	08/05/2003	CA	75.0	75		F	07/30/2003	Info has been received from a physician concerning a 75 year old female who on 10/30/2002 was vaccinated intramuscularly in the left deltoid with a dose of pneumococcal vaccine 23 polyvalent (Lot #643504/0735M). On 10/30/2002 concomitant therapy included an intramuscular dose of influenza virus vaccine (FLUZONE) (lot number U0920AA) in the right deltoid. On 10/30/2002 in the PM, the pt developed a local reaction at site of the pneumococcal vaccine 23 polyvalent with redness and itching, that was reported on 11/01/2002. Subsequently, the pt recovered. The physician also reported on 4 other pts (WAES #0302USA02179, 0303USA01861, 0303USA01728 and 0303USA01730). No further info is expected.									Y	10/30/2002	10/30/2002	0	Body weight measurement (10/?/02) 151 pounds.	PVT	PVT			UNK		WAES0303USA01727	1						1	Injection site erythema; Pruritus	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0735M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0207421	08/05/2003	MI	40.0	40		M	07/30/2003	Info has been received from a licensed practical nurse concerning a 40 year-old male volunteer firefighter with no known drug allergies and no known medical conditions who on 12/02/2002 at 19:00 was vaccinated intramuscularly in the deltoid with a first dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M). There was no illness at the time of vaccination and no symptoms following prior vaccination with the pt or his siblings. Concomitant therapy on 12/02/2002 at 19:00 included an intramuscular dose in the opposite deltoid of influenza virus vaccine (FLUZONE) (Batch #U0925AA). Both doses were given with a 25 guage, 1 needle. It was noted that 2 hours after the vaccine was given he spent 20 hours at a fire scene and was engaged at times in heavy physical labor. On 12/03/2002 at 21:00, the pt developed swelling, pain, erythema and induration from elbow to shoulder. The duration was 1 week and he did not require medical care as a result of this. It was also noted that the nurse had suspected that this activity played a major role in their reactions. The pt recovered on 12/09/2002. The nurse also reported on 9 other pts that were vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M) and developed induration (WAES #0212USA01192, 0212USA01193, 0212USA00729, 0212USA00825, 0304USA02076, 0304USA02077, 0304USA02078, 0304USA02079 and 0304USA02081). No further info is expected.									Y	12/02/2002	12/03/2002	1	Body height measurement: 75 inches. Body weight measurement: 218 lbs.	OTH	OTH			NONE		WAES0304USA02075	1						1	Injection site erythema; Injection site induration; Injection site oedema; Pain	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0445M~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0207424	08/05/2003	MI	45.0	45		M	07/30/2003	Info has been received from a licensed practical nurse concerning a 45 year old male volunteer firefighter with no known drug allergies and no known medical conditions who on 12/02/2002 at 19:00 was vaccinated intramuscularly in the deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M). On 12/02/2002 at 19:00 concomitant therapy included an intramuscular dose in the opposite deltoid of influenza virus vaccine (FLUZONE) (Batch #U0925AA). There were no other concomitant medications. Both doses were given with a 25 guage, 1 needle. There was no illness at the time of vaccination and no symptoms following prior vaccinations with the pt or his siblings. It was noted that 2 hours after the vaccine was given, he spent 20 hours at a fire scene and was engaged at times in heavy physical labor. On 12/03/2002 at 21:00, the pt developed extremity stiffness, pain and induration from elbow to shoulder. The duration was 24 hours and he did not require medical care as a result of this. It was also noted that the nurse had suspected the activity played a major role in their reactions. The pt recovered on 12/05/2002. The nurse also reported on 9 other pts that were vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (643251/0445M) and developed induration (WAES #0212USA01192, 0212USA01193, 0212USA00729, 0212USA00825, 0304USA02075, 0304USA02076, 0304USA02077, 0304USA02079 and 0304USA02081. No further info is expected.									Y	12/02/2002	12/03/2002	1	Body height measurement: 69 inches. Body weight measurement: 210 lbs.	OTH	OTH			NONE		WAES0304USA02078	1						1	Injection site induration; Musculoskeletal stiffness; Pain	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0445M~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0207425	08/05/2003	MI				M	07/30/2003	Information has been received from a LPN concerning a male firefighter who on 12/02/2002 at 19:00 was vaccinated IM in the deltoid with a first dose pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M).  On 12/02/2002 at 19:00 concomitant therapy included an IM dose in the opposite deltoid of influenza virus vaccine (FLUZONE) (Batch # U0925AA).  Both doses were given with a 25 guage, 1  needle.  It was noted that 2 hours after receiving the vaccine, he spent the next 20 hours at a fire scene and was engaged at times in heavy physical labor.  It was noted that the patient was unable to be contacted for a complete interview and the patient's fire department captain reported the symptoms.  On 12/03/2002 at 21:00 the patient developed pain, redness, swelling at the injection site, induration from elbow to shoulder and did not require medical care as result of this.  It was also noted that the nurse had suspected the activity played a major role in their reactions.  The nurse also reported on 9 other patients that were vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (LOT #: 643251/0445M) and developed induration (WAES #'s: 0212USA01192, 0212USA01193, 0212USA00729, 0212USA00825, 0304USA02075, 0304USA02076, 0304USA02077, 0304USA02078, 0304USA02081).  No further information is expected.									U	12/02/2002	12/03/2003	366	UNK	OTH	PVT	NONE	NONE	UNK		0304USA02079	1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0445M~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0207426	08/05/2003	MI	41.0	41		M	07/30/2003	Information has been received from a LPN concerning a 41 year old white male volunteer firefighter with no known allergies and no known medical conditions who on 12/02/2002 at 19:00 was vaccinated IM in the deltoid with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M).  On 12/02/2002 at 19:00 concomitant therapy included an IM dose in the opposite deltoid of influenza vaccine (FLUZONE) (Batch # U0925AA). Both doses were given with a 25 guage 1 needle.  Other concomitant medications were propranolol HCl (INDERAL), doxepin HCl and alprazolam (XANAX).  There was no illness at the time of vaccination and no symptoms following prior vaccinations with the patient or his siblins.  It was noted that 2 hours after the vaccine was given, he spent 20 hours at a fire scene and was engaged at times in heavy physical labor.  On 12/03/2002 at 21:00 the patient developed pain, redness, swelling, induration from elbow to shouler and did not require medical care as result of this.  It was also noted that the nurse had suspected the activity played a major role in their reactions.  The patient recovered on 12/09/2002 after 1 week.  The nurse also reported on 9 other patients that were vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M) and developed induration (WAES #'s: 0212USA01192, 0212USA01193, 0212USA00729, 0212USA00825, 0304USA02075, 0304USA02076, 0304USA02077, 0304USA02078, 0304USA02079).  No further information is expected.									Y	12/02/2002	12/03/2002	1	Body height: 61 inches; Body weight: 200lbs;	OTH	PVT	Xanax, Doxepin hydrochloride, indernal	UNK	NONE		0304USA02081	1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0445M~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0207457	08/05/2003	NY	60.0			U	07/30/2003	Information has been received from a physician concerning an approximately 60 year old patient who in approximately October 2002 was vaccinated in the arm with a dose of pneumococcal vaccine 23 polyvalent (Lot # 642722/0165M).  Concomitant therapy, that same day, included a dose of influenza virus vaccine in the opposite arm.  Within hours of vaccination, in approximately October 2002, the patient developed a big time reaction from the deltoid to the elbow.  The reaction persisted for 3 to 5 days.  The patient received palliative treatment.  The physician reported that the patient had prior vaccination with pneumococcal vaccine 23 polyvalent over 5 years ago.  The reporter expressed a concern with the lot.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  The patient sough unspecified medical attention.  Additional information has been requested.  This is one of a total of four patients.  Three other patients had similar reactions after vaccinations with pneumococcal vaccine 23 polyvalent (WAES # 0210USA02060, 0306USA02765, 0306USA02766).				Y					Y	10/01/2002	10/01/2002	0	UNK	OTH	OTH	UNK	UNK	UNK		0306USA02764	1						1	Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0165M~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207458	08/05/2003	NY	60.0			U	07/30/2003	Information has been received from a physician concerning an approximately 60 year old pt who in approximately October 2002, was vaccinated in the arm with a dose of pneumoccocal vaccine 23 polyvalent (lot# 642722/0165M). Concomitant therapy, that same day, included a dose of influenza virus vaccine in the opposite arm. Within hours of vaccination, in approximately October 2002, the pt developed a big time reaction from the deltoid to the elbow. These reaction persisted for 3 to 5 days. The pt received palliative treatment. The physician reported that the pt had prior vaccination with pneumococcal vaccine 23 polyvalent over 5 years ago. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by GMP compliance and found to be satisfactory. The lot complies with the standards of the CBER and was released. The pt sought unspecified medical attention. Additional information has been requested. This is one of a total of four patients. Three other patients had similar reactions after pneumococcal vaccine 23 polyvalent (WAES numbers 0210USA02060, 0306USA02764 and 0306USA02766).				Y					Y	10/01/2002	10/01/2002	0	UNK	OTH	OTH			UNK		WAES0306USA02765	1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0165M~2~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0207459	08/05/2003	NY	60.0			U	07/30/2003	Information has been received from a physician concerning an approximately 60 year old pt who in approximately October 2002, were vaccinated in the arm with a dose of pneumococcal vaccine 23 polyvalent (lot# 642722/0165M). Concomitant therapy, that same day, included a dose of influenza virus vaccine in the opposite arm. Within hours of vaccination, in approximately October 2002, the pt developed a big time reaction from the deltoid to the elbow. The reaction persisted for 3 to 5 days. The pt received palliative treatment. The physician reported that the pt had prior vaccination with pneumococcal vaccine 23 polyvalent over 5 years ago. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by GMP compliance and found to be satisfactory. The lot complies with the standards of the CBER and was released. The pt sought unspecified medical attention. Additional information has been requested. This is one of a total of four patients. Three other patients had similar reactions after vaccination with pneumococcal vaccine 23 polyvalent (WAES 0210USA02060, 0306USA2764 and 0306USA02765).				Y					Y	10/01/2002	10/01/2002	0	UNK	OTH	OTH			UNK		WAES0306USA02766	1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0165M~2~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0198576	08/12/2003	GA	21.0	20		M	08/12/2003	Client completed 4 week follow-up with cardiologist - no complaints of chest pain/tightness, dyspnea or other cardiac related symptom of myocarditis; does continue to have headaches intermittently			Y	Y	Y				Y	02/05/2003	02/13/2003	8	Echocardiography,exercise stress test and ECG are WNL	MIL	MIL	None	Strep Throat developed within 72 hours of vaccination	None			1						2	Chest pain; Myocarditis; Headache; Myocarditis; Laboratory test abnormal; Nonspecific reaction	FLU3~SANOFI PASTEUR~U0957AA~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020071~1~~~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~U1203~2~IM~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|ANTH~EMERGENT BIOSOLUTIONS~~2~~~ANTHRAX (BIOTHRAX)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|SMALL~PFIZER\WYETH~~1~~~SMALLPOX (DRYVAX)~2|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~2|SMALL~PFIZER\WYETH~~1~~~SMALLPOX (DRYVAX)~3	USA	Life Threatening,Hospitalisation	Influenza
0207834	08/14/2003	CA	18.0	18		M	08/11/2003	From initial information received on 8/7/03 from a medical professional, regarding an adverse event occurring in the US, it was reported that an 18year old male patient received MENOMUNE, lot number UB245AA, FLUZONE (lot number not reported), TUBERSOL (lot number not reported), HEPATITIS A VACCINE (lot number and manufacturer not reported, HEPATITIS B VACCINE (lot number and manufacturer not reported), MMR (lot number not reported), and PNEUMOVAX (lot number not reported) administered on 11/14/02. All vaccines were administered on the same date. The patient died on 12/15/02. The CDC investigation confirmed that the patient was positive for serogroup C, Meningococcal infection. The onset date of signs and symptoms were not reported. An autopsy was performed, however, results were not available at the time of this report. Follow-up information: Information has been received from a health professional concerning an 18 year old male patient who was healthy with no adverse entry who on 11/14/2002 was vaccinated with a dose of MMRII (Lot # not reported).  Concomitant therapy on 11/14/2002 included a dose of hepatitis A vaccine (inactive) (manufacturer unknown) (Lot # not reported), a dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) (Lot # not reported), a dose of pneumococcal vaccine 23 polyvalent (MSD) (Lot # not reported), a dose of tuberculin in purified protein derivative (TUBERSOL) (Lot # not reported), a dose of influenza virus vaccine (FLUZONE) (Lot # not reported) and a dose of meningococcal polysaccharide vaccine (MENOMUME-A/C/Y/W-135) (Lot # UB245AA).  Subsequently the patient died on 12/15/2002.  It was confirmed that the patient was positive for serogroup C Meningococcal infection.  The onset date of signs and symptoms were not reported.  An autopsy was performed; however, the results were not available at the time of the report.  From additional information received on 08/12/2003 from a pathology department, it was reported that the patient presented with an acute onset of a rash on his feet that spread to his face over a period of a few hours, after a 3 day history of a cough and sore throat.  The symptoms progressed rapidly to severe respiratory distress and shock.  The patient was treated with advanced cardiac life support in the ICU (intensive care unit) and died within three hours of presenting to the hospital.  The patient died at 1:01 pm on 12/15/2002; the autopsy was done the following day and showed that the cause of death was Neisseria Meningitidis Septicemia (Meningococcemia).  Gross autopsy findings included evidence acute shock syndrome with diffuse petechia and hemorrhage to multiple organs, visceral congestions, shock kidneys, and a blothcy erythematous rash to the organs and a few scattered foci of acute inflammation within the myocardium and meninges.  The clinical presentation, autopsy findings, and laboratory PCR results were consistent with Neisseria Meningitidis (meningococcal) Septicemia (special pathogens branch # M10158).  The manner of death was natural.  The CDC confirmed that the patient was positive for serogroup C Meningococcal infection.  Final anatomical diagnosis from the autopsy report included:  Diffuse discrete petechiae and small hemorrhages involving multiple organs, serosa and mucosal surfaces (intestines, mesentery, epicardium, myocardium, renal cortex, adrenals, lungs, pharynx, bronchi, skeletal muscle and conjuctica), pulmonary edema and visceral congestion, bilateral pleural and pericardial effusions, blotchy erythematous rash on face, trunk, arms and legs, shock kidneys with diffuse pale cortices.  there was no purulent meningeal exudates present.  The PCR results were positive for Neisseria Meningitidis Serogroup C.  Microscopic findings included: Numerous fibrin micro thrombi in heart, lungs, liver, glomeruli, brain and oropharynx and scattered small foci of acute inflammation in meninges and myocardium associated with hemorrhage and focal myocyte necrosis.  Microscopic descriptions included:  Trachea-diffuse mucosal and submucosal hemorrhage without inflammation.  Lung-diffuse alveolar damage with numerous scattered fibrin and conspicous granulocytes present in red pulp.  Liver-sinusoidal congestion with sinusoids distended by granulocytes and scattered fibrin micro thrombi.  Prostate and bladder-mucosal and glandular autolysis, no pathologic diagnosis.  There were no radiographs taken.  Toxicology results included: Volatiles-the blood and vitereous fluid were examined for the presence of ethanol at a cutoff of 20 mg/dl.  No ethanol was detected.  The following drugs were detected: Positive Lidocaine-Lidocaine was detected in the liver by gas chromatography and confirmed by gas chromatography/mass spectrometry.  Positive Atropine-Atropine was detected in the liver by gas chromatography/mass.	Y	12/15/2002							N	11/14/2002			Diagnostic Laboratory: PCR was positive for Neisseria Meningococcal infection serogroup C.	MIL	UNK	PPD		NONE		200301574	1						1	Bacterial infection; Cough; Drug ineffective; Dyspnoea; Laboratory test abnormal; Pharyngitis; Rash maculo-papular; Respiratory distress; Sepsis; Shock; Infection; Laboratory test abnormal; Meningitis	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|MEN~SANOFI PASTEUR~UB245AA~UNK~~~MENINGOCOCCAL (MENOMUNE)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|HEP~MERCK & CO. INC.~~UNK~~~HEP B (RECOMBIVAX HB)~2|HEPA~MERCK & CO. INC.~~UNK~~~HEP A (VAQTA)~2|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~2|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~2|TTOX~SANOFI PASTEUR~~UNK~~~TETANUS TOXOID (NO BRAND NAME)~2|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~3|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~3|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~3|MEN~SANOFI PASTEUR~UB245AA~UNK~~~MENINGOCOCCAL (MENOMUNE)~3|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~3|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~3	USA	Results in Death	Influenza
0207865	08/15/2003	CO	1.5	1	.5	M	07/01/2003	The night after our son started waking up at 2:00am screaming hysterically and unable to go back to sleep until 5am. This pattern continued. He started not eating well and unable to nap. A month later he had a grand mal seizure. Three months later he had another and then another.				Y	Y		Y		U	11/04/2002	11/06/2002	2	EEG; MRI's, etc.	PVT	PVT	NONE	NONE	NONE	~DTaP (no brand name)~1~0.50~In Patient		1						1	Grand mal convulsion; Insomnia; Oral intake reduced; Screaming	DTAP~SANOFI PASTEUR~U0584AA~4~~~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U0883AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0208035	08/18/2003	CA	40.0			F	08/18/2003	THIS R.N. SINCE THE TIME OF THE INFLUENZA INJECTION HAS HAD A LARGE DIMPLE IN HER ARM WHICH HAS CONTINUED TO ITCH.													N/A	PUB	PVT		N/A	N/A			1						1	Pruritus; Skin necrosis	FLU3~EVANS VACCINES~E 35462HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0207986	08/19/2003	NY	69.0	69		M	05/31/2005	A 70 year old male received RSV vaccine or Placebo and Influenza vaccine on 11/05/2002 and 251 days later died.  Obituary stated patient died suddenly, no further information at this time.  The investigator assessed the event as unrelated to the study product.  Follow up information received 08/12/2003.  Subject # 00100989.  The investigator spoke with family member regarding patient's death.  Patient was found by his wife sitting in a chair.  Autopsy was performed and cause of death was listed as massive myocardial infarction.  Investigator assessed the event as unrelated to the study product.  Additional information received 09/03/2003.  Certificate of Death: Date of death: 07/14/2003.  Manner of Death: Natural cause.  Immediate Cause: Arrythmia/MI.  Approximate interval between onset and death is 1 day.  Due to or as a consequence of: End state emphysema.  Approximate interval between onset and death is years.  Did tobacco use contribute to death: Yes.  Preliminary Anatomic Diagnosis: 07/16/2003.  Diagnosis: Coronary Artery Atherosclerosis: Left circumflex 75% narrowed (left dominant circulation).  Cardiomegaly, 500 grams.  Severe Centriacinar Emphysema, bilateral.  Subsidiary Diagnosis: Nodular hypertrophy of prostate.  Simple renal cyst, left.  Small pulmonary embolus.  Meckel's diverticulum.  Colonic diverticula.  Probable cause of death: Cardiac Arrhythmia secondary to coronary artery disease.  Autopsy Limitations: none.  Embalmed: no.  Pending studies: Toxicology-blood, vitreous humor, bile, liver, stomach contents. Medical Records received on 8/27/2003 states arrythmia and coronary artery disease.	Y	07/14/2003							N	11/05/2002	07/14/2003	251	Pending studies: Toxicology-blood, vitreous humor, bile, liver, stomach contents.	UNK	UNK	Placebo, RSV, Lipitor, Unaretic, Combivent, Atrovent		COPD; HTN; Colon cancer 1992		200301328	1						1	Arrhythmia; Coronary artery disease; Myocardial infarction	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0207987	08/19/2003	NY	84.0	83		M		An 83 year old male received RSV 11 Vaccine or Placebo and Influenza Vaccine on 10/16/2002 and 267 days later died on 07/10/2003. The pt's obituary was seen in the paper. No further info is available at this time but site will contact the family for further details. The Investigator assessed the event as unrelated to the study product. The pt had 3 prior hospitalizations, in 12/31/2002 admitted with a diagnosis of pneumonia (sputum culture pseudomonas), in March for a respiratory illness which did not improve after 2 courses of antibiotics. While in the hospital he had Oxacillin resistant Staph. Aureus and Pneumonia was diagnosed. He was also hospitalized on 04/04/2003 with symptoms of vomiting, diarrhea, abdominal pain, temperature of 103 F. and an oxygen saturation of 82%. A 15-day follow up report received 8/29/2003 adds: Additional info received 8/12/2003. The Investigator spoke with family member regarding pt's death. Pt was admitted to hospice on 07/01/2003 due to increased SOB and respiratory problems. Pt remained in hospice until death on 07/10/2003. Death certificate states Severe COPD as cause of death. Investigator assessed the event as unrelated to the study product. Follow up on 09/17/2003: Additional information received 09/08/2003.  Copy of Certificate of Death: Cause of Death: Severe Chronic Obstructive Pulmonary Disease.  Other Significant Conditions Contributing to Death But Not Related to Cause: Recurrent Pneumonia. Death Certificate received on 9/12/2003 states COD was COPD.	Y	07/10/2003							N	10/16/2002				UNK	UNK	Duoneb, Flovent, Zoloft, Guaifenesin, Ativan, Tylenol Extra strength, Inhaled gentamicin		COPD, O2 Dependent, CHF, Aortic Stenosis, Osteoarthritis, Angioplasty 1996.  Relevant history from previous hospitalizations:  On 12/20/2002 the patient was cultured for illness 65 days after vaccination.  On 12/23/2002 he went to MD and was placed on Zithromax.  Patient was recultred and placed on Levaquin 12/27/2002. On 12/31/2002 the patient went to visit MD (scheduled visit), and was admitted to the hospital, 76 days after vaccination, with initial symptoms of a sore throat, hoarseness, nasal stuffiness, cough, tiredness.  Patient became short of breath as cold progressed.  He had a chest x-ray done twice with a diagnosis of Pneumonica-Sputum culture-pseudomonas.  He was treated with one dose of Ciprofloxacin and a course of Levaquin and required supplemental oxygen.  Outcome-Recovered with Residual Effects on 01/10/2003.  Patient never fully returned to baseline.  Investigator assessed the event as unrelated to the study product.  He was admitted to the hospital again on 04/08/2003.  On 02/19/2003, 126 days after vaccination, he was cultured for respiratory illness.  He complained of increased sputum, cough with chills and feverishness, while on antibiotics per MD.  He did not get better after 2 courses of antibiotics, became increasingly SOB and was admitted to the hospital on 03/08/2003 (143 days after vaccination) due to increased shortness of breath.  He was placed on increased oxygen, ahd 2 chest x-rayx and was started on inhaled Gentamicin.  While in the hospital had ORSA (Oxacillin Resistant Staph Aureaus) and Pneumonia was diagnosed.  Patient had 3 chest x-rayx, MRI, CAT scan.  He was released from hospital after 7 days on inhaled Gentamicin and Prednisone, home oxygen and use of Acapella flutter valve.  The investigator assessed the event as unrelated to the study products.  Date Discharged 03/14/2003.  The third hospitalization occurred on 04/04/2003, 170 days after vaccination.  He experienced vomiting, diarrhea, abdominal pain, a temperature of 103 F, oxygen saturation of 82% and was admitted to the hospital.  Questionable ischemic bowel or diverticulitis.  Patient transferred to ICU for observation.  Thought to be septic.  NG tube placed. Received multiple blood transfusions.  The investigator assessed the event as unrelated to the study product.		200301313	1						1	Abdominal pain; Cough; Diarrhoea; Dysphonia; Dyspnoea; Fatigue; Feeling cold; Lung disorder; Nasal congestion; Pharyngolaryngeal pain; Pneumonia; Productive cough; Pyrexia; Respiratory disorder; Vomiting	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0207834	08/22/2003		18.0			M	08/18/2003	Information has been received from a health professional concerning an 18 year old male patient who on 11/14/2002 was vaccinated with a dose of MMRII (Lot # not reported).  Concomitant therapy on 11/14/2002 included a dose of hepatitis A vaccine (inactive)(manufacturer unknown)(Lot # not reported), a dose of hepatitis B virus vaccine rHBsAg (yeast)(manufacturer unknown)(Lot # not reported), a dose of pneumococcal vaccine 23 polyvalent (MSD) (Lot # not reported), a dose of tuberculin purified protein derivative (TUBERSOL)(Lot # not reported), a dose of influenza virus vaccine (FLUZONE)(Lot # not reported) and a dose of meningococcal polysaccharide vaccine (MENOMUNE-A/C/Y/W-135)(Lot # UB245AA).  Subsequently the patient died on 12/15/2002.  It was confirmed that the patient was positive for serogroup C Meningococcal infection.  The onset date of signs and symptoms were not reported.  An autopsy was performed; however, the results were not available at the time of the report.  Other business partner numbers include 2003-01574.	Y								N	11/14/2002			Diagnostic lab: Patient was positive for serogroup C Meningococcal infection.	OTH	OTH			UNK		WAES0308USA01211	1						2	Bacterial infection; Cough; Drug ineffective; Dyspnoea; Laboratory test abnormal; Pharyngitis; Rash maculo-papular; Respiratory distress; Sepsis; Shock; Infection; Laboratory test abnormal; Meningitis	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|MEN~SANOFI PASTEUR~UB245AA~UNK~~~MENINGOCOCCAL (MENOMUNE)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|HEP~MERCK & CO. INC.~~UNK~~~HEP B (RECOMBIVAX HB)~2|HEPA~MERCK & CO. INC.~~UNK~~~HEP A (VAQTA)~2|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~2|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~2|TTOX~SANOFI PASTEUR~~UNK~~~TETANUS TOXOID (NO BRAND NAME)~2|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~3|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~3|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~3|MEN~SANOFI PASTEUR~UB245AA~UNK~~~MENINGOCOCCAL (MENOMUNE)~3|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~3|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~3	USA	Results in Death	Influenza
0208170	08/22/2003	NY	73.0	73		F		This subject is a 73 year old female who was admitted to the hospital due to increased dyspnea, cough and sputum on 8/7/03 while enrolled in the RSV 11 study with RSV vaccine. The subject received RSV vaccine or placebo and Influenza vaccine on 10/16/02. The subject developed lung cancer 6 months post immunization (diagnosed in April 2003) and presented with increased dyspnea, cough and sputum 295 days post immunization and was admitted to the hospital 295 days later on 8/7/03. Subject died in hospital 6 days later on 8/13/03. The event was reported by the investigator as not related to the study product. A follow up report received 8/26/2003 adds: This subject is a 73 year old female who was admitted to the hospital due to increased dyspnea, cough and sputum on 08/07/2003 while enrolled in the RSV 11 study with RSV Vaccine. The pt received RSV Vaccine or Placebo and Influenza vaccine on 10/16/2002.  The subject developed lung cancer 6 months post immunization (diagnosed in April 2003) and presented with increased dyspnea, cough and sputum 295 days post immunization and was admitted to the hospital 295 days later on 08/07/2003. Pt died in hospital 6 days later on 08/13/2003.  The event was reported by the Investigator as not related to the study product. Medical Records received on 8/26/2003 states pallor and unresponsive.	Y	08/13/2003			Y	6			N	10/16/2002	04/01/2003	167	Sodium 136; K 4.7; Chloride 98; CO2 28; BUN 22; Creatinine 1.2; Glucose 124; White count 12.7; Hematocrit 39; Platelet count 558; O2 saturation 91% on two liters nasal cannula; Chest x-ray: right lung basilar opacity with effusion; EKG: sin	UNK	UNK	Placebo, RSV, Vicodin, Combivent, Pulmicort, Serevent, Duragesic, Ativan		Lung cancer diagnosed April 2003. Chronic obstructive pulmonary disease, osteoarthritis, osteoporosis. Lung cancer with bone metastasis. No known allergies.		200301615	1						1	Cough; Dyspnoea; Laboratory test abnormal; Lung neoplasm malignant; Pallor; Productive cough; Stupor	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0208171	08/22/2003	FL	75.0	75		M		This subject is a 76 year old male who died on 7/24/03 due to his emphysema while enrolled in the RSV 11 study with RSV vaccine. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/10/02. The subject died 287 days post immunization. The subject's family phoned on 8/15/03 to notify the investigator that the subject expired from emphysema on 7/24/03. The event was reported by the investigator as unrelated to the study product. A 15-day follow up report received 8/26/03 adds: Additional info received 08/22/2003. Previous medical history received and available in source documents. Discharge Summary: 04/24/2002. History and Physical: 04/24/2002. Progress Notes: 1/4/00, 1/25/00, 3/6/00, 3/1/01, 6/29/02, 7/8/02. Final diagnoses: 1. Exacerbation of chronic obstructive pulmonary disease with bronchitis. 2. Gastrointestinal bleed secondary to polyps. He will be discharged on Atrovent metered dose inhaler two puffs p.o. q6h. Ventolin metered dose inhaler two puffs spo q6h. Theophylline 300mg po bid, Ceftin 500mg po bid for the next five days and Prednisone 6mg po once a day to be tapered as an outpatient. Diet and activity can be as tolerated. He will follow-up with myself and with Dr. Hospital Course: He was admitted for exacerbation of COPD. He was placed on bronchodilators, antibiotics, oxygen and IV Theophylline and steroids. He showed a steady improvement as his medication was tapered on the final hospital day. He was back to his baseline and did not have dyspnea on exertion. While in the hospital, he had an episode of GI bleeding. Dr. was consulted. Colonoscopy was done. He had noted to have a rectal mass and multiple colon polyps and anal stenosis. Biopsies were done. H&H remained stable. At this time, no further in-hospital management is planned and he can be followed as an outpatient. Impression: 1. Severe COPD. 2. Weight loss. Maintain Prednisone at 20mg per day. Continue on Pulmicort, Atrovent, and Albuterol. Follow-up again in one month. Death certificate states congestive heart failure. Additional info received 9/19/03. Follow up report. Diagnosis: Emphysema, chronic obstructive pulmonary disease, congestive heart failure. Progress notes: 9/19/03. Patients certificate of death received and noted. Immediate cause linked as COPD and congestive heart failure. Review reveals no evidence of cong. failure in this facility. Pt received his injection of RSV vaccine in Oct. 2002. Deceased July 24, 2003. Death certificate received. Cause of death: End stage chronic obstructive pulmonary disease, congestive heart failure. The investigator assessed the events as unrelated to the study products. Follow up on 09/17/2003: Additional information received 09/05/2003.  Family reports death certificate states: A-End stage of chronic osbructive pulmonary disease.  B-Congestive heart failure.  Copy pending.  Diagnosis: Chronic Obstructive Pulmonary Disease, Emphysema.  The death was reported by the investigator as not related to the study product.	Y	07/24/2003							N	10/10/2002			First CPK was negative.  Blood gas revealed hypoxia. However, he was not acidotic.  Chem-7 was okay. CBC and elevated white blood count of 17.  Theophylline was 10.	UNK	UNK	Lasix, Theophylline, Combivent, Oxygen, Aerobid, Guaifenesin, Rabeprazole, Prednosone		Emphysema, Chronic Obstructive Pulmonary Disease, Additional information received 08/22/2003.  Previous history: Discharge Summary: 04/24/2002.  Date of Admission: 04/15/2002.  Date of Discharge: FINAL DIAGNOSIS: 1) Exacerbation of chronic obstructive pulmonary disease with bronchitis. 2) Gastrointestinal bleed secondary to polyps.  PLAN: He will be discharged on Atrovent metered dose inhaler two puffs p.o. q6h, Ventolin metered dose inhaler two puffs p.o. q6h.  Theophylline 300 mg p.o. three times daily, Ceftin 500 mg p.o. three times daily for the next five days and Prednisone 6 mg p.o. once a day to be tapered as an outpatient.  Diet and activity can be as tolerated.  He will follow up with myself and with MD.  HOSPITAL COURSE: He was admitted for exacerbation of COPD.  He was placed on bronchodilators, antibiotics, oxygen and IV Theophylline and steroids.  He showed a steady improvement as his medication was tapered on the final hosptial day.  He was back to his baseline and did not have dyspnea on exertion.  While in the hospital, he had an episode of GI bleeding.  MD was consulted.  Colonoscopy was done.  He had noted to have a rectal mass and multiple colon polyps and anal stenosis.  Biopsies were done.  H&H remained stable.  At this time, no further in-hospital management is planned and he can be followed as an outpatient.  H&P: Chief complaint: Dyspnea.  HISTORY: A 76 year old male who developed several days of increasing shortness of breath with chills. He had not been keeping up with his medications.  He presented to the ER where treatment there did not resolve his symptoms and he was referred to me for exacerbation of chronic obstructive pulmonary disease with probable underlying bronchitis.  He has had a productive cough.  MEDICATIONS: Emphysema, Theophylline, Combivent, Albuterol.  PAST MEDICAL HISTORY: Emphysema, Back pain.  FAMILY HISTORY:  Non contributory.  SOCIAL HISTORY: He is a former smoker but has not smoked in several years.  REVIEW OF SYSTEMS: Chiefly remarkable for the chronic back pain, otherwise not remarkable. PHYSICAL EXAMINATION: General: appeared well.  Vital signs: Pulse 136, Respirations 36, blood pressure 160.82.  Temperature: 98.6.  HEENT: Not remarkable.  Neck: No JVD or bruit.  Heart: Had a regular rate and rhythm.  Abdomen: soft, good bowel sounds.  Lungs: Crackles an wheezing in all fields.  Neurological: not remarkable.  Extremities: no edema.		200301625	1						1	Bronchitis; Cardiac failure; Condition aggravated; Lung disorder; Polyp; Weight decreased	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0208175	08/22/2003	AR				F	01/09/2003	A consumer reported that she received a dose of flu vaccine (manufacturer unknown) in 1995 and subsequently developed a runny nose for a week. No further information was available at the date of this report.									U					OTH	OTH	UNK	UNK	UNK	Tired, draggy, Not feeling well~Influenza (Seasonal) (no brand name)~~0.00~In Patient	HQ6074008JAN2003	1						1	Rhinorrhoea	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0208176	08/22/2003	NJ				F	12/03/2002	A female consumer reported that she received a dose of influenza virus vaccine, trivalent, types A & B in 1999. Medical history included allergy to sulfonamides. Subsequent to immunization, she experienced soreness at the injection site oh her arm, which lasted 1-2 days. The caller reported she had the same reaction she after she received the influenza virus vaccine in 1998, 2000 and 2001. No further information was available at the date of this report.									U				UNK	OTH	OTH	UNK	UNK	Drug hypersensitivity	Same reaction~Influenza (Seasonal) (no brand name)~~0.00~In Patient	HQ5559502DEC2002	1						1	Injection site pain	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0208199	08/22/2003	NC	59.0			M	08/18/2003	Urticaria. Neomycin clipped into vaccine, unbeknownst to me.									Y					PVT	PVT			Neomycin			1						1	Urticaria	FLU3~EVANS VACCINES~E36592KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0208279	08/26/2003	CO	72.0	72		F		This subject is a 73 year old female who died at home 240 days post immunization on 7/11/03 while enrolled in the RSV 11 study. The subject received the RSV vaccine or Placebo and influenza vaccine on 11/13/02. The subject was diagnosed with pneumonia a few days before her death. Subject was not admitted to hospital and was found in her home on 7/11/03. The death was reported by the investigator as not related to the study product. Death certificate states cause of death as Probable complications of hypertensive heart disease. Other significant conditions, chronic obstructive pulmonary disease, obesity. No autopsy performed. Additional documents received and with source documents: Certificate of Death: 8/20/03.	Y	07/11/2003							N	11/13/2002				UNK	UNK	RSV, Placebo, Micronase, Glucophage, Inderal, Prinivil, Combivent, Mobic, Celexa, vicodin, Oxybutynin, Estring, oxygen		COPD, hypertension, diabetes type II, neuropathy, depression, obesity, spinal stenosis		200301742	1						1	Cor pulmonale; Hypertension; Pneumonia	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0208284	08/26/2003	WI	83.0	83		F		Burning in bilateral feet began within 1 week after receiving the flu shot. Burning in bilateral hands on fire started the end of January. Difficulty using arms, walking, and speaking progressed to point now of barely being able to use arms, walk and speak. In last month, diagnosed with Motor Neuron Disease. The medical record received on 1/2/04 states anxiety, depression, parkinsonism, cerical radiculitis, shoulder pain, dizziness and hands cold. 60 day follow up on 11/26/03: Vaccine recipient did not recover from adverse events that were reported for this vaccination.  Diagnosed with ALS.  Recipient can't walk and can't move arms.  Speech ability is poor.  Progressively getting worse.  This information collected from recipients daughter. Information from Discharge summary states neuropathy, anorexia, weight loss, dysphagia, urinary tract infection; from medical record, herniated disc, twitching. msv			Y	Y	Y	7			N	11/06/2002	11/13/2002	7	From medical records abnormal lab values. msv	OTH	PUB		NONE	Hypertension, glaucoma  Information from discharge summary states depression, anxiety, macular degeneration, osteoarthritis, hydronephrosis; from medical records, herpes zoster. msv			1						1	Anorexia; Anxiety; Bone disorder; Depression; Difficulty in walking; Dizziness; Dysphagia; Extrapyramidal disorder; Hypokinesia; Muscle contractions involuntary; Neck pain; Neuropathy; Paraesthesia; Shoulder pain; Skin burning sensation; Speech disorder; Urinary tract infection; Weight decreased	FLU3~SANOFI PASTEUR~U0954AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0208330	08/26/2003	CA	41.0	40		F	08/14/2003	Pt states within seconds of receiving flu shot, she felt flushed, dizziness and nausea. Had one prior flu shot few years before with no problem. Since then states health has deteriorated. Has intermittent episodes of a variety of ? Fibromyalgia, headache, wt. loss (50 lbs.), memory loss, blurred vision, jerking facial muscles and other muscles. Has seen MD with no particular diagnosis other than the flu and fibromyalgia. Was hospitalized in March 2003 for 7 1/2 days with dehydration and fatigue. Believes her health problems  began after receiving flu shot and was healthy before.				Y					N	11/03/2002	11/03/2002	0	UNK	PUB	PUB	NONE	NONE	NONE		CA030101	1						1	Amnesia; Dehydration; Dizziness; Dyskinesia; Fatigue; Fibromyalgia; Flushing; Headache; Nausea; Vision blurred; Weight decreased	FLU3~SANOFI PASTEUR~U0919AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0208404	08/27/2003	PA	54.0	53		F	07/30/2003	Patient transferred from hospital with fever and rash. Patient got flu shot 1st time 4 weeks prior. Patient developed cough. Antibiotics given. Approximately 1.5 weeks PTA, patient noticed lesions on right hip and pruritic area on back of right arm. Patient on prednisone. Systemic vasculitis 2 hours to flu vaccine. Still rash on 12/6/02. Nurse follow up on 05/26/04: fever, systemic lupus erythematosus, Cough. Medical records state purpura, anemia. msv					Y				N	11/04/2002	11/20/2002	16	ESR 76 Medical records stateabnormal lab test, RBCs decreased, PT-PTT decreased. msv	PVT	OTH	Glipizide, Nizatidine; Monopril; MVI; Vitamin C; Hydrocodone; Vitamin B2	UNK	NKDA; DM; HTN; RA; Polymyositis Medical records states ostopenia, hernia.msv			1						1	Anaemia; Coagulation time shortened; Cough; Laboratory test abnormal; Purpura; Pyrexia; Rash; Rash pruritic; Skin ulcer; Systemic lupus erythematosus; Vasculitis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0208463	08/28/2003	AR	27.0			F	01/09/2003	A consumer reported that she received a dose of flu vaccine in 1964 and subsequently became very sick. No further information was available at the date of this report.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQ6073908JAN2003	1						1	Unevaluable event	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0208464	08/28/2003	NJ				F	12/03/2002	A female consumer reported that she received a dose of influenza virus vaccine, trivalent, types A & B in 1998. Medical history included allergy to sulfonamides. Subsequent to immunization, she experienced soreness at the injection site on her arm, which lasted 1-2 days. She reported that she experienced the same reaction after she received influenza vaccine in 1999, 2000, and 2001. No further information was available as of the date of this report.									U				UNK	OTH	OTH	UNK	UNK	Hypersensitivity		HQ5504525NOV2002	1						1	Injection site pain	FLU3~PFIZER\WYETH~~1~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0208465	08/28/2003	MI	74.0			F	04/23/2003	A 78 year old female reported that she received 1/3 of a normal dose of a flu vaccine in 1998 at 74 years of age. Her medical history includes diabetes, stent placement for blocked arteries, an unspecified thyroid condition, and allergies to eggs, nuts, shellfish, and penicillin. Concomitant medications at the time of the event included Synthroid and Premarin. Following vaccination, she developed redness at the injection site. She recovered. No further information was available at the date of this report.									Y				UNK	OTH	OTH	Premarin; Synthroid	UNK	Diabetes mellitus; Drug hypersensitivity; Food allergy; Menopause; Thyroid disorder; Coronary arterial stent; Coronary artery occlusion		HQWYE711816APR03	1						1	Injection site erythema	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0208638	08/31/2003	LA	21.0	20		F	08/15/2003	PREGNANCY AFTER SMALLPOX/ANTHRAX VACCINES									U	02/27/2003	04/27/2003	59	POSITIVE HCG TEST	MIL	MIL	NONE	NONE				1						1	Unintended pregnancy	FLUX~UNKNOWN MANUFACTURER~WO057AA~1~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~MERCK & CO. INC.~0835M~1~IM~UN~HEP B (FOREIGN)~1|HEPA~MERCK & CO. INC.~0834M~1~IM~UN~HEP A (VAQTA)~1|SMALL~PFIZER\WYETH~4020071~1~ID~UN~SMALLPOX (DRYVAX)~1	USA		Influenza
0208570	09/02/2003		75.0			M		A report was received on 2/28/02 concerning a 75 year old male pt who experienced exacerbation of chronic obstructive pulmonary disease on 10/20/98 after receiving Fluvirin vaccine on 10/10/98. The event was considered serious as the pt was hospitalized. It is not known if the pt had recovered at the time of reporting the event. The reporter has assessed the causality as possibly related. No more info has been provided. ID no. HQ1160922MAY2001					Y				U	10/10/1998	10/20/1998	10		UNK	UNK					PJP200200174	1						1	Condition aggravated; Lung disorder	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0208855	09/05/2003	WA	66.0	66		M		Pt received RSV/Placebo and Influenza vaccine on 10/15/02 and 4 hrs later developed severe dyspnea with minimal activity and COPD exacerbation. Pt reported difficulty in sleeping due to dyspnea. On 10/17/02, the pt reported symptoms to the pulmonary physician, principal investigator, and study coordinator. On 10/18/02, pt was diagnosed with COPD exacerbation at the ER. On 10/19, pt reported sleeping more comfortably, but labored breathing and decreased volume capacity continues as of 10/24. On 10/24, reported difficulty in sleeping (sleeping in chair). Treatment included Albuterol Nebulizer and Prednisone tapering. Currently on Prednisone 30mg per day. On 10/29/02, pt visited pulmonary physician who provided the following additional info: Pt has a progressive hisotry of worsening SOB on exertion for past 2-3 years. Became more pronounced after an episode of pneumonia in April 2001 and 2nd episode April 2002. Became very SOB when carrying any weight e.g. boxes. Not prednisone dependent and never intubated. On 8/20/02, pt called and complained of SOB and cough and sputum. Resolved with antibiotics. On 10/29/02 complained of severe SOB. Denied worsening cough, increased sputum or fever. Dramatic deterioration of pulmonary status with decrease in FEV 1 from 0.9 to 0.52 and severe SOB. No evidence of acute bacterial infection, no increase in cough, sputum, (recent CXR after symptoms showed no infiltrates). Prescribed higher dose of prednisone for longer period 40mg daily for 2 weeks. On 11/12/02 pt saw pulmonary physician who reports that there is no improvement with prednisone in fact breathing may be slightly worse this week. Has developed minimal lower extremity edema with the prednisone. Pt denies chest pain. Pulmonary physician states concerned of a rapidly progressive obstructive disease other than COPD; a possibility would be constructive bronchiolitis or even panbronchiolitis. Due to new onset of pitting edema, cardiac function will be evaluated. CT of the chest with high resolution cuts, and echocardiogram will be scheduled. Follow-up info received 11/26/02: CT chest W&W/O Contrast: In the left lower superior segment, image 28, there is nodular hazy ground glass opacity peripherally located. This area has some bronchiectasis on high resolution images and may be a focal area of fibrosis. However, findings are non-specific and a BAC nodules or masses are seen. There are multiple, small, less than 1cm mediastinal lymph nodes. Extensive coronary artery and vascular calcifications are noted. There are no significant focal areas of air trapping. There is mild bronchiectasis. No pleural effusions. No suspicious bony lesions. Images of the upper abdomen appear grossly normal. Impression: 1. Small, hazy peripheral opacity in the left lobe superior segment with postinflammatory scarring. However given a bronchial alveolar cell carcinoma could appear similar, a 3 month follow-up study is recommended. Severe centrilobular eymphysema and mild bronchiectasis. Extensive coronary artery calcifications. Cardio echo preliminary report: The aortic root and valve appear normal without AI. The left atrium appears dilated by 20 apical imaging. The left ventricle appears normal in wall thickness, chamber size and systolic function. The right heart appears normal in size and function. There is tract TR. There is no pericardial effusions. Pulmonary function test 11/12/02: Summary: severe airflow obstruction and improvement after inhaled bronchodilators. No significant change since last testing. Follow-up info received 12/5/02: Pulmonary physician visit of 12/3/02-Physician states This fall pt experienced a dramatic worsening in symptoms, associated with a significant decrease in FEV 1. He failed a trial of prednisone, but after we initiated treatment with nebulized albuterol and Atrovent BID and Fluticasone BID, he now feels better, and interestingly the FEV 1 has increased to 0.60. Comes today for routine f/u. HEENT: Nasal and oral mucosa moist; lung: moving more air than on previous visits. B/L rales. Heart: RRR no murmurs. EXT: no cyanosis, 1+ edema b/l. FEV 1 has established with current treatment. Will continue present regime and repeat a CT scan in 3 months as suggested by radiology. Will also refer to ophthalmology at pt's request. Site coordinator reports on 12/5/02, subject called to report a constant dull deep pain behind right shoulder blade in the right lung area. Subject denies URI or any physical activity that would cause this pain, denies chest pain, neck pain or pain down either arm. Subject reports continued difficulty breathing. Was advised to see physician. Subject called site coordinator to report that he has an appointment 12/5/02. Follow-up info is expected. Follow-up info received 12/13/02/PCP progress notes: 12/3/02-CXR-no pneumonia. WBC is 23-wondering if pt was on steroids or any other RX. He is responding to nebulizer well, will continue to monitor. 2/5/02-experiencing sharp pain in right scapular area with deep breathing. Speaking in whole sentences. Has good 02 sat. (92% on room air). Chest is clear to auscultation. T 98; P 66; BP 158/70; PO2 92% RA. CXR reveals emphysema-no infiltrates. Pleuritic chest pain, prescribed Celebrex 200mg-qid and oxycodone 3/Acet 1q 4-6h prn. Follow-up info received 3/31/03: Pulmonary function test. Interpretation: Spirometry: severe reduction of airflow rates (FEV1 and FEF 25-75) and FEV1/FVC, indicating airflow obstruction. Bronchodilator response: airflow improves by 13% after inhaled bronchodilators. Lung volumes: reduced SVC, indicating either restriction, or air trapping. Other lung volumes were not measures. Blood gases: none. Summary/impression: Severe airflow obstruction and improvement after inhaled bronchodilators. Pulmonary phone contact note 3/20/03: Pt went to his primary MD, who prescribed home oxygen. His oxygen sat was 89 to 90 at rest, and then about 89 when walking. Both the pt and his caretaker, think that he is feeling better with the oxygen. The physician will put a consult to home O2 at the VA (clinic), although in the clinic he has not met criteria for home O2. From CT chest 3/26/03: clinical history: 66 year old smoker with COPD would like to perform a follow-up CT scan; pt had a previous CT in December read as images that could be c/w BAC, suggest follow-up in 3 months. Report: comparison: CT of thorax performed 11/15/02. Findings: As before, there is severe centrilobular emphysema diffusely and bilaterally. Previously noted are of high attenuation in left lower lobe superior segment is unchanged in size and has a centrally located 5mm nodule as well as multiple linear components, which are consistent with fibrosis or intersititial disease. In addition there are new focal linear areas of consolidation, likely scar or atelectasis in right lower lobe and the lingula, which favor radiographic appearance of fibrosis more than airspace disease. As before, there are multiple small sub-centimeter mediastinal lymph nodes. In addition there is a soft tissue nodule in the subcarinal region measuring 14mm, previously 13mm, which may represent scar and/or lymph nodes. No pleural effusion. Heart size is normal. NO pericardial effusion. Once again, there is extensive coronary artery and vascular caldification. The bones are unremarkable. visualized portions of the upper abdomen are normal. The pt is status post cholecystectomy. Impression: 1. Stable left lower lobe linear interstitial scarring with mild centrilobular component. New right lower lobe and lingular interstitial disease and fibrosis. If continued clinical concern, additional imaging to demonstrate stability over 24 months is recommended. An imaging schedule of 6 months, 12 months and 24 months after initial scan would be reasonable. No evidence of progression of left lower lobe nodule to suggest bronchioalveolar carcinoma. 2. Severe centrilobular emphysema. 3. Extensive coronary artery and vascular calcification, indicating atherosclerosis. The investigator assessed the event as probably related to the study product. Follow-up info received 4/9/03. Pulmonary outpatient visit note 6/4/02: 66 y/o man with hx of emphysema whose care is being transferred to the VA from HMC, where he was being followed by physician. Also has a primary care MD. The pt is currently at his respiratory baseline and comes to establish care here at the VA. Background: Smoking history of 100pack/years, quit 4/4/02 with hypnosis. Has had progressive history of worsening SOB on exertion for the past 2-3 years, which has become more pronounced after an episode of pneumonia in 4/01 and a second episode in April 2002. Otherwise has never been intubated and is not of pneumonia in April 2001 and a second episode in April 2002. Otherwise has never been intubated and is not prednisone/dependent. Bronchodilator requirements: Combivent PRN, uses 1 canister/month approx. Prednisone responsiveness: FEV 1 increased from 0.910L to 1.110L after 2-week prrednisone trial in April 2001; not associated with symptomatic improvement. Has also postnasal dripping controlled with Claritin and Flonase; no symptoms of GERD. Baseline: currently can walk on flat ground without stopping, can do one flight of stairs but becomes very SOB when carrying any weight like boxes etc. Has no night symptoms, minimal cough/ sputum not prednisone/O2 dependent. Meds: Combivnet 2 puffs qid prn, Claritin, Flovent 2 puffs BID. All: NKDA. PMH: COPD, FEV1=0.9, cholecystectomy 1984, TIA 1996, heart flutter. Social: pets: 1 dog, no cats, no birds. Allergic to pollens. Retired. Physical exam: no actute distress. Mild SB when walking to the office from waiting room. Wt 147 lbs BP 157/76 HR83 Pox 95% RA. HEENT: oropharynx and nasopharynx clear without discharge/ lesions. Neck: soft, supple, no bruits/masses. Heart: no gallop, murmurs. Lungs: diffusely decreased breath sounds. Abd soft nontender. Et: no edema. No cyanosis, clubbing. COPD major goals are: 1. decrease breathlessness if possible; 2. prevent additional loss of lung function. Goal: 1. will continue present treatment with combivent and Fluticasone. The pt has not been using the fluticasone regularly because of problems of access to the medication, now he will receive it thru the VA. If the current therapeutic regime results in no symtomatic improvement, will consider low dose theophylline during the next visit. Will check oxymetry on exertion next visit. Goal 2: prevent additional loss of lung function. Will give a course of antibiotics to the to keep at home and use in the event of another exacerbation. Encouraged the pt to use regularly his medications for post-nasal drip (flonase and claritin) which he has been using sporadically. Will check PFT and CXR prior to next visit as a baseline for our clinic. Next appointment: 6 months. Pulmonary phone contact note 8/20/02. Pt called to day reporting increase in coughing and more phlegm being produced in gray color. Per doctor he has been instructed to start taking azithromycin and call me on Friday with update on how he is feeling. If he is getting worse he should go to the PEC. If feeling better he needs to come to pulmonary clinic on 9/3 for follow up. Pulmonary phone contact note 4/4/03. Called the pt to notify him of the official CT results. He is aware of his appointment next week. He has stopped all his oral medications-including metoprolol and theophylline-because they were doing nothing, and he says that he now feels better. He would like me to write a letter to the utilities companies, which are threatening with cutting his services. I will place a request for a primary care physician here at the VA, because it appears that his contacts with his MD are minimal and he definitely needs a PCP coordinating his care. Follow up info received 4/29/03: Medical records of subject covering period 3/2701 to 3/12/02 prior to the event in the study are attached. Follow up info received 5/5/03. Medical records of subject covering period 1989t o 3/25/03 are attached. Follow up info received 6/16/03: Pulmonary outpatient visit note on 6/14/03. This is a routine follow-up for this 67 year old male followed up for severe COPD. Previous clinic visit: 3/7/03. Recent events: Today pt says that his breathing is worse. He mentioned that his former caretaker, is no longer with him, and complains that caretaker left a stole money from him. Pt also complains that some of his pills from the VA were stolen. He is very upset because we are giving him an antidepressant, referring to the trazodone. When I explained that the trazodone was being prescribed to help with anxiety and with sleep, he said that he had never had problems with anxiety of sleep-despite having mentioned the opposite in previous visits. Pt also asked me about his recent appointment with social services, and mentioned the he had always been compliant with all his medications, and denied having ever stopped taking any meds. PE: BP: 154/64, HR 72, Pox=99% RA. NAD: Today pt can speak full sentences without SOB. Lungs: breath sounds bilaterally, scattered rales. Heart: ERR no murmurs. EXT: no cyanosis. Echo 11/15/02: N1 LV function, no PASP noted. CT chest 11/15/02: 1. Small hazy peripheral opacity in the left lobe superior segment with areas of bronchiectasis. Imaging findings are nonspecific; however, likely represent fibrosis or postinflammatory scarring. However, given a bronchial alveolar cell carcinoma could appear similar, a three-month follow up study is recommended. 2. Severe centrilobular emphysema and mild bronchiectasis. 3. Extensive coronary artery calcifications. A/P: 1. Severe COPD without hypoxemia or pulmonary hypertension. FEV1 is markedly improved today. After his last visit, we had consider adding serevent-however I am a little unsure about modifying his medication regime, not only because his FEV1 is improving, but also to avoid further complicating his medication regime. I am concerned that over time, there has been discrepancies re. the medications that pt admits to be taking, and also that the pt has again declined home help. Will follow up in 3-4 months. Repeat CT scan is due in Sep/Nov. Pulmonary function test from 6/10/03 with source documents. Additional info received 8/27/03. Pulmonary telephone contact note: 7/21/03. Subject called today. He has visited doctor, a community pulmonologist, who repeated the PFT and prescribed some new medications, including QVAR and  other medications. Subject has requested doctor to get in contact with us. Otherwise, he is feeling very well today. Health promotion screening note 7/31/03. 67 y/o male seen at VA cooperative health screening by internist who documented the following per his chart note as follows: PMH: COPD. Denies h/o htn, cancer, etoch abuse, DM, PVD, subs abuse. PSHx: chole, pinal cyst removed. Meds: Albuteral MDI, Atrovent MDI, ALL: NKA. SHx: 1pppd smoker. Fhx: mother w/DM. ROS: dyspnea, ?nocturia, otherwise neg. O:T: 96.6 BP: ras 176/118 LAS 200/102 P: 69R: 24 HT 147 lbs HT 68. PE: CVS: S1S2, tachy RR, no m/g/r. C/L: symmetrical chest expansion, harsh exp wheezing. Ext: DP 2+, no c/c, 3mm edema. Rectal: deferred. ECG today-NSR; PR 166 QRSD 67 QT 387 QTc 411 P 84 QRS 76 T 83. A/P 1. Severe COPD, recommended close plum f/u, may required O2 in future, f/u plum VA 26th as planned, Pneumovac today, needs PCM. 2. blepharitis, Augmentin 500mg bid #20. 3. Eczema, f/u w/ PMD as planned. Concur w/ above, Augmentin 500mg bid x 10 days ordered to be mailed ASAP. Pharmacy general progress note 8/1/03: Saw subject for pharmacy care. Allergy info: NKDA; says he was injected with something and his breathing capacity went below 15%. Meds: Augmentin 500mg BID-Rx from clinic, pls mail to pt ASAP; pls contact pharmacy finish the Rx when the order in placed in the computer to expedite delivery. A/P: pt says that he also gets Foradil form outside, not sure the name exactly. Informed pt to call in to the pharmacy and let me know what other meds he is on from outside. Pulmonary outpatient visit note 8/26/03: Same as for 6/14/03 with addition of FEV1 ranges from 0.49 to 0.99. Not Prednisone/O2 dependent. Medications: Medications prescribed available in source documents. Recent events: Last visit, we noticed the subject FEV1 had improved to 0.99 up from 0.49 in April. We had initially planned to start him on Serevent, but didn't do so because FEV1 was improving, and I did not want to make his medication regime more confusing because I have been extremely concerned about his compliance with medications. At any rate, following his last visit subject visited pulmonologist. Pulmonoglosit's impression was end-stage emphysematous lung disease and prescribed QVAR, Formoterol and DuoNebs. As per their notes, which were faxed to me, Pulmonologist was aware that subject has prescribed nebs and fluticasone. Comes today to a routine visit. Today he is very pleasant. He continues to be worried about the sudden increased in FEV1 from 0.49 to 0.99 because he thinks that such as abrupt change must be a technical mistake and complained that he continues to be very sick, even though the test suggest he is getting better. I emphasized that his COPD is severe in either test, and that there will be variability from test to test, and in any case his treatment remains the same. Subject also mentioned that he has noticed some improvement with the combination of Albuterol and Atrovent, and also mentions that he is requiring less Albuterol MDI with the Formoterol. He has not been using the QVAR. Today subject can speak full sentences without SOB. Lungs: breath sounds bilaterally, scattered rales, today has wheezing on left lung field. Heart: RRR no murmurs. EXT: no cyanosis. A/P 1. Severe COPD without hypoxemia or pulmonary hypertension. Now that he has two pulmonologist, I am even more concerned that before re: medication compliance, although he mentions that his primary pulmonary care will remain with us. Will add Formoterol and Atrovent/Albuterol nebs, because these seem to have improved. Abnormal CT scan with possible BAC. Bronchiectasis stable. Follow up on 02/13/04 states: Additional information received 02/05/04.  No further information is available on this subject at this time. This subject was withdrawn from the study on 05/07/03 and last date of contact was dated 10/08/03.  The consent form did not allow further access to medical records.  Additional information received and available in source file: letter from department dated 02/03/04. Follow up 12/06/04: Patient recovery status unknown.				Y					N	10/15/2002	10/15/2002	0	CXR: Acute bronchitis, no pneumonia; PFT Interpretation: Spirometry: severe reduction of airflow rates and FEV1/FVC, indicating airflow obstruction, Bronchodilator response: airflow improves by 13% after inhaled bronchodilators; Lung volumes: reduced SVC, indicating either restriction, or air trapping. Other lung volumes were not measured; Blood gasses none; CT of thorax performed, severe centrilobular emphysema diffusely and bilaterally. Previously noted are of high attenuation in left lower lobe superior segment is unchanged in size and has a centrally located 5mm nodule as well as multiple linear components, which are consistent with fibrosis or interstitial disease. In addition there are new focal linear areas of consolidation, likely scar or atelectasis in right lower lobe and the lingula, which favor radiographic appearance of fibrosis more than airspace disease. As before, there are multiple small sub-centimeter mediastinal lymph nodes. In addition there is a soft tissue nodule in the subcarinal region measuring 14 mm, previously 33mm, which may represent scar and/or lymph nodes. No pleural effusion; Heart size normal, no pericardial effusion; Extensive coronary artery and vascular calcification; Bones are unremarkable; Visualized portions of the upper abdomen are normal;	UNK	UNK	RSV/Placebo, combivent, Albuterol, Corgard, Azithromycin, Fluticasone, Trazodone		Emphysema; tobacco use (pact a day-quit April/2002); alcohol (2-3 beers per night); seasonal allergies, cholecystectomy 1984; TIA 1996; Heart murmur; allergies-NKDA-pt states he was injected with something (does not know what it was) and his breathing capacity went to below 15%.		C200200607	1						1	Cough; Dyspnoea; Insomnia; Laboratory test abnormal; Lung disorder; Oedema peripheral; Productive cough	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0207834	09/11/2003		18.0			M	08/07/2003	From initial info received on 8/7/03 from a medical professional, regarding an adverse event. It was reported that an 18 year old male pt received Menomune, lot number UB245AA, Fluzone, Tubersol, Hep A vaccine, Hep B vaccine, MMR, and Pneumovax administered on 11/14/02. All vaccines were administered on the same date. The pt died on 12/15/02. The Center for Disease Control investigation confirmed that the pt was positive for serogroup C, Meningococcal infection. The onset date of signs and symptoms were not reported. An autopsy was performed; however, results were not available at the time of this report.	Y	12/15/2002							N	11/14/2002	12/15/2002	31	Positive for serogroup C, Meningococcal infection. An autopsy was performed; however, results were not available at the time of this report.	UNK	UNK	Tubersol					1						3	Bacterial infection; Cough; Drug ineffective; Dyspnoea; Laboratory test abnormal; Pharyngitis; Rash maculo-papular; Respiratory distress; Sepsis; Shock; Infection; Laboratory test abnormal; Meningitis	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|MEN~SANOFI PASTEUR~UB245AA~UNK~~~MENINGOCOCCAL (MENOMUNE)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|HEP~MERCK & CO. INC.~~UNK~~~HEP B (RECOMBIVAX HB)~2|HEPA~MERCK & CO. INC.~~UNK~~~HEP A (VAQTA)~2|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~2|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~2|TTOX~SANOFI PASTEUR~~UNK~~~TETANUS TOXOID (NO BRAND NAME)~2|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~3|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~3|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~3|MEN~SANOFI PASTEUR~UB245AA~UNK~~~MENINGOCOCCAL (MENOMUNE)~3|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~3|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~3	USA	Results in Death	Influenza
0209117	09/11/2003	IL	83.0	82		F		This subject is a 83 year old female who died 6/15/03 in the hospital while enrolled in the RSV 1I study with RSV vaccine. The subject received a dose of RSV vaccine or Placebo and Influenza vaccine on 10/03/2002. The subject developed congestive heart failure and COPD with acute exacerbation 254 days post immunization and was admitted to the hospital 254 days later on 6/14/03. The subject died 255 days post immunization on 6/15/03. The investigator has assessed the events as unrelated to the study products. Medical Certificate of Death: Immediate cause resulting in Death - Congestive heart failure. Further information has been requested.	Y	06/15/2003							N	03/10/2002	06/14/2003	461		UNK	UNK	Placebo/ RSV		Cough; Shortness of breath; Hemoptysis; Pneumonia; COPD		200301835	1						1	Cardiac failure congestive; Condition aggravated	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0209178	09/15/2003	DC	82.0	81		M		This subject is an 82 year old male who was admitted to the hospital on 8/13/03 and died 2 days later on 8/15/03 while enrolled in RSV 11 study, with RSV vaccine or Placebo and Influenza vaccine. The subject received study vaccine on 10/31/02. Subject developed nausea, vomiting, abdominal distention and pain 286 days post immunization and was admitted to the hospital 286 days later on 8/13/02. Subject was diagnosed with gangrene of small bowel, congestive heart failure, chronic atrial fibrillation, embolus of the superior mesenteric artery. Treatment included the medication, Restoril, Remeron, Protonix, Lasix, Lisinopril and IV antibiotics. Subject died 2 days later on 8/15/03. The causality has not been assessed by the investigator as of yet, additional information has been requested. On examination, he was mentally alert. He was complaining of quite a bit of pain. His abdomen was distended. At first, bowel sounds were absent. Note, he gave a history of passing flatus on the day prior to admission and having a bowel movement, but none on the day of admission. The patient was given IV fluids. He was not given antibiotics at first. His Coumadin was discontinued. His other medications continued were appropriate. On the morning of 8/14/03, the patient had had nasogastric suction overnight, which was fairly profuse. He was still complaining of abdominal pain but stated that he had passed some flatus during the night. His white count became elevated. He was therefore placed on broad spectrum antibiotics. We discussed the possibility of proceeding with surgery with him. He said he wanted to avoid this if at all possible. A CT of the abdomen was obtained, and this suggested proximally dilated bowel and collapsed distal bowel. Our impression at this time was on of an incomplete small bowel obstruction, particularly in view of the fact that he recently passed flatus, and there was a considerable amount of gas in the colon. The patient was treated overnight. On the morning of 8/15/03, however, his white count had dropped only minimally. He was still complaining of pain. His abdominal distention had not decreased. His nasogastric suction was quite profuse. We recommended surgery. He discussed this with his daughter in some detail and considered not giving permission but finally relented. He was aware that he was at high risk and that even offered his comment that he thought he would not survive the surgery. He was taken to the surgical area where an A line and a Swan-Ganz catheter was placed. He already had a Foley catheter in situ. He was taken to surgery. At the time of surgery, ischemia of the entire bowel was found in the distribution of the superior mesenteric artery. The bowel was clearly not viable. The abdomen was therefore closed. The patient returned to recovery room where he was kept on large doses of vasopressors but was maintaining inadequate blood pressure. He was kept on a ventilator. Later, after discussion with his daughter and on our advice, we discontinued the vasopressor, and within just a few minutes, he developed cardiac asystole. He was pronounced dead as 2:30 pm on 8/15/03. An autopsy was declined by the family.  A 15-day follow up report received 09/30/2003 adds: Final Diagnosis: 1. Gangrene of the small bowel. 2. Probable embolus of the superior mesenteric artery. 3. Chronic atrial fibrillation. 4. Congestive heart failure. 5. Recurrent pleural effusions.	Y	08/15/2003			Y	2			N	10/31/2002	08/13/2003	286		UNK	UNK	Coumadin, Restoril, Remeron, Protonix, Lasix, Lisinopril, Coymadin		Surgery a few years ago for a small bowel obstruction, chrome atrial fibrillation , CHF, recurrent pleural effusions, open cholecystectomy		200301863	1						1	Abdominal distension; Atrial fibrillation; Cardiac failure congestive; Coronary artery embolism; Intestinal gangrene; Nausea; Pain; Pleural effusion; Vomiting; White blood cell count increased	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0209338	09/17/2003	FL	0.2	0	.2	F	09/11/2003	7/8/03 received 5 vaccine shots. On 7/21/03 rash. Called doctor 7/22/03. Said viral infection. Doctor got bloodwork done on 7/22/03. On 7/24/03 doctor said neutrophils very low. Sent me to a hematology specialist, redid blood work, neutrophils went from 350 to 900. Dr. said probably from vaccines. We got back in 1 month.									U	07/08/2003	07/21/2003	13	Blood work on 7/22/03. Neutrophils at 350 (negative), redid blood work on 7/24/03, neutrophils at 900.	PVT	OTH						1						1	Rash; Viral infection; White blood cell count decreased	DTAP~SANOFI PASTEUR~U0849AA~1~IM~~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UA771AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~5320A9~2~IM~~HEP B (ENGERIX-B)~1|IPV~SANOFI PASTEUR~W0869~1~IM~~POLIO VIRUS, INACT. (POLIOVAX)~1	USA		Influenza
0209373	09/17/2003	IL	65.0	65		F	09/10/2003	Red rash about 3 inches in diameter around site of injection, non-warm, no swelling, minor itching. First noticed 2+ hours after injection. No other symptoms. No topical or oral meds taken for treatment. Pt seen incidentally for another purpose.									Y	09/05/2003	09/05/2003	0		PVT	PVT	Lisinopril, Lorazepam, Zoloft		High blood pressure, Type II diabetes, high cholesterol, depression, glaucoma			1						1	Injection site erythema; Pruritus; Rash	FLU3~SANOFI PASTEUR~U1074AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0841AA~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0209417	09/18/2003	TX	36.0	36		M	09/17/2003	Headache, greater than 15 aphthous ulcers cervical LAD (Lymphadenopathy)									Y	09/10/2003	09/12/2003	2	NONE	OTH	PVT	NONE	NONE	SULFA			1						1	Aphthous stomatitis; Headache	FLU3~SANOFI PASTEUR~U1074AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0209462	09/22/2003	NC	73.0	73		F		The medical record states chest pain, hypertension and heart failure. Aditional info received 9/26/03. A death certificate was obtained for the subject. Date of death: 6/8/03. The cause of death was due to ischemic cardiovascular disease. Relevant hisotry section contains cardiology consultation and 2D Echo and Doppler study 2/11/03 and medical history notes 4/23/03 and 2/28/03. The ischemic cardiovascular disease was reported by the investigator as unrelated to the study product. Cardiology consultation 2/11/03. Pt presents today for evaluation prior to undergoing total hip replacement scheduled for 2/20/03. Dr has requested prior to pt undergoing a surgical procedure. Presently pt seems to be doing quite well, with her primary complaint being of hip pain that is now limiting her mobility. Specifically she denies chest discomfort, shortness of brreath, dyspnea on exertion (although she is not able to probably do enough to develop dyspnea), lower extremity swelling, orthopnea, PND, chest discomfort or palpitations. She seems to be complying with her medications fairly well although, as usual, she expresses a desire to get off them. Current medications: Coumadin, Spironolactone 26mg qd, Lasix 40mg qd, KCI 20meg qd, Coenzyme Q10, 50mg qd, Atacand/HCT 16/12.5mg qd, Triamterene 100mg qd. Physical examination: she is a lean female in no acute distress. Wt was not recorded today, but in late January it was 126.25lbs. P 84 and irregularly irregular.  BP146/72 in the left arm in the seated position using a normal size cuff. HEENT exam reveals normocephatic, atraumatic head. Conjunctiva and lids are clear. Mucus membranes are dry but pink. Neck is supple without lymphadenopathy or thryromegaly. JVP is 9cm with negative HJR. Carotids are 2+ bialterally without brutis. Lungs are clear to auscultation and there is no accessory muscle use in her respiratory effort at rest. Cardiac exam reveals on enlarged an dlaterally displaced apical impulse with an irregularly irregular rhythm and a normal S1, S2. There are no gallops or rubs. There is a 11/V1 systolic murmur at the left lower sternal border which is unchanged. Extremities reveal no edema, and the peripheral pulses are 2+ and symmetric throughout. A 12-lead lectrocardiogram was obtained at hte time of her visit. This revealed atrial fibrillation with a controlled ventricular response of 80 beats/minute. She has a left anterior fascicular block, and LVH with secondary QRS widening and repolarization abnormalities. Since her last tracing dated 4/12/02 her heart rate was decreased by 10 beats/minute, but otherwise there are no significant changes. Also at the time of her visit, she underwent a 2D echo and doppler study which is reported separately. Impressions: 1) hypertension iwth hypertensive cardiomyopathy. The hypertension is relatively well controlled at this time. In addition, it is noted that her heart failure, which was rather severe back in April of last year, has improved significantly since then. More than likely this is due to the addition of Spironolactone and Atacand to her medical regimen. 2) Bialteral hip osteoarthritis with the left being worse than the right. She is scheduled to undergo surgery for hip replacement in ten days. I will forward a letter the Dr with specific recommendations regarding ways to minimize potential adverse events related to the pt's cardiac dysfunction perioperatively. Plan: 1) Continue current medications at their current dosages with the exception of Coumadin which will be discontinued seven days prior to this surgery with the substitutionof IV heparin for the Coumadin three days prior to the surgery. 2) Start Toprol XL 12.5 mg qhs today, and continue for at least one month following this surgery. 3) Return for follow-up with me in six to eight weeks. 2D echo and doppler study 2/11/03. Indication: heart failure. Bialteral atrial enlargement with a left atrial internal dimension of 48mm in the parastenal long axis view. Concentric left ventricular hypertrophy with left ventricular enlargement and moderately severe systolic dysfunction which is likely due to hypertensive cardiomyopoathy. The LVEF today is measured at 37 percent which is an improvement from 10 to 15 percent measured approxximately ten months ago. Right ventricular enlargement with normal systolic function. Aortic valve with normal leaflets but annular calcification. There is mild AR but no AS. Mitral valve with normal anterior mitral leaflet, but the posterior leaflet is somewhat limited in its mobility. There is mitral annular calcification and moderate mitral regurgitation which is due to the abnormal posterior leaflet. Normal tricuspid valve with moderate TR and moderately elevated PA systolic pressure of 51mm/Hg. Medical history notes: 4/23/03. Pt returned for follow-up of heart failure and hypertension. Actually follow-up was specifically requested by Dr due to worsening symptoms of chest pain. Sine her last visit the pt reports the occurrence of chest pain about once a week at random times. There is no relationship to exercise or time of day. She denies SOB, dyspnea on exertion, rhythm disturbance, orthopnea, PND, anorexia, early satiety and lower extremity swelling. She does report chest pain/discomfort. She denies nausea, vomiting, diarrhea, diaphoresis or pleuritic pain. She is planning a trip on 5/9/03. Current medications: Coumadin, Spironolactone 25mg qd, Lasix 40mg qd, KCI 20meg qd, Coenzyme Q10, 50mg qd, Atacand/HCT, 16/12.5mg qd, multivitamin one qd, Synthroid 25mcg qd. A 12-lead electrocardiogram was obtained at the time of her visit which revealed atrial fibrillation with a ventricular response at 80, normal axis, a left anterior fascicular block and normal QT interval. Sine her last tracing dated 2/11/03 there are no significant changes. Impression: chest pain. Given atypical pattern and character, suspect non-cardiac etiology. Heart failure. Remarkably stable. Hypertension. Relatively well controlled on current medications. Plan: samples of Protonix 40mg one po qam. Follow up on Monday 4/28/03 at 8:30am. If chest pain is unimproved with the addition of proton pump inhibitor, will likely refer for adenosine sestamibi vs dobutamine echo (non-exercise due to severe osteoarthritis). Medical history notes: 4/28/03: Pt returned for follow-up of chest pain. At her last visit (4/23/03) I started her on Protonix, 40mg qd, based on the suspicion that the chest pain might be due to GERD. Since her last visit she reports definite decrease in her chest pain. Current mecication: Coumadin, Spironolactone 25mg qd, Lasix 40mg qd, KCI 20mcg qd, Coenzyme Q10, 50mg qd, Atacand/HCT 16/12.5mg qd, multivitamin one qd, Synthroid 25mcg qd, Protonix 40mg qd. Impression: chest pain. Improved significantly after five days of Protonix. Plan: continue Protonix, 40mg qd for four weeks (total), then 40mg qod for four weeks, then discontinue. Follow up in two months. Note to Dr. Autopsy report received on 10/01/2003 states COD was cardiovascular disease.	Y	06/01/2003							N	10/30/2002	06/01/2003	214		UNK	UNK					200301995	1						1	Cardiac failure; Cardiovascular disorder; Chest pain; Hypertension	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0209565	09/24/2003	IN	60.0	60		F	09/17/2003	The pt developed an exaggerated localized reaction with hyperemia and induration incompassing over area of 8.5 x 8cm to Lt brachium (shoulder).									Y	09/16/2003	09/17/2003	1		OTH	PVT		NONE	NONE			1						1	Hyperaemia; Injection site induration	FLU3~EVANS VACCINES~765484~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0209658	09/24/2003	UT	1.8	1	.8	M	09/24/2003	RASH, WARM, INDURATED, REDNESS. KEFLEX WAS USED AS TREATMENT.				Y					U	09/22/2003	09/24/2003	2	NONE	PVT	PVT		NONE	NONE			1						1	Feeling hot; Injection site erythema; Injection site induration; Rash	DTAP~SANOFI PASTEUR~C1526AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1256AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE012AA~4~IM~RL~HIB (ACTHIB)~1	USA	Emergency room visit	Influenza
0209660	09/24/2003	FL	34.0	34		F	09/24/2003	Received ?? vaccine to L arm on 9/13/03.  Provider ordered Pneumovax & Flu vaccine, however, it was documented on my immunization card that I received a Flu vaccine & Varivax on 9/13/03 @ approximately 10:20am.  When I returned to the doctor's office on 9/15/03, no one could tell me what I had actually received. On 9/13/03 in the afternoon, I experienced soreness to my L arm.  By nightfall, the soreness turned to pain.  On 9/14/04, I experienced redness, warmth, swelling to my L deltoid area & excruciating pain to my L arm, L shoulder & L breast area.  When I looked at my immunization card to see what I had received, I noticed that Varivax was documented.  On 9/15/03 @ 8:35am I returned to the doctor's office for an eval & to confirm what Immunization had been given.  The MD could not tell me what had been administered, as there was no documentation-just initials by what the pac ordered. I was given an RX for Prednisone & instructed to follow up on 9/19/03.  On follow up on 9/19/03, the cellulitis to my L arm had resolved.				Y					Y	09/13/2003	09/13/2003	0	None	PVT	UNK	Allegra-D 12 hr 1 PO BID Ortho Tri-Cyclen 1 PO Daily Singulair 10 mg PO qHS Rhinocort AQ Nasal Spray 1 puff each nostril qHS	None	Asthma Allergic Rhinitis Hx + varicella @ 9 yrs old			1						1	Cellulitis; Drug administration error; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~7+~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0209691	09/26/2003	DC	76.0			F	09/22/2003	Pt had a flu-like syndrome with sore throat, cough, subjective fever, back pains.									Y				NONE	PVT	OTH			NONE			1						1	Back pain; Cough; Influenza like illness; Pharyngolaryngeal pain; Pyrexia	FLU3~EVANS VACCINES~765138~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0209699	09/26/2003	IL	1.25	1	.3	M	04/07/2002	1/7/97: fever and vomit, crabby, congestion, not sleeping. 1/13/97: crabby, fever, congestion, not sleeping. 1/21/97: ear-fluid. 1/30/97: fever, not sleeping, bad breath. 2/3/97: rash on abdomen-red dots spread to the rest of the body over the week.				Y					Y	01/02/1997	01/03/1997	1		PVT	OTH		NONE	NONE	~Measles + Mumps + Rubella (no brand name)~~2.00~In Sibling		1						1	Breath odour; Insomnia; Irritability; Pyrexia; Rash; Vomiting	FLUX~UNKNOWN MANUFACTURER~6H71194~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0392D~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0209731	09/29/2003	TX	59.0	59		F	09/26/2003	Right arm swollen, hot to touch, pain when touched. Red spots on deltoid. Took Benadryl and Cortisone.				Y					U	09/24/2003	09/26/2003	2		PVT	PVT	Bextra, Azmacort, CAH, Proventil, Nasonex		Codeine			1						1	Injection site oedema; Injection site warmth; Pain; Rash	FLU3~SANOFI PASTEUR~U1094AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1079M~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0209801	09/30/2003	NY	57.0	57		F	09/28/2003	Swelling of deltoid. Ice applied after 15 minutes. No further swelling noted.									Y	09/28/2003	09/28/2003	0		PVT	PVT	NONE	NONE	NONE			1						1	Injection site oedema	FLU3~SANOFI PASTEUR~U1139AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0209868	10/01/2003	GA	43.0	43		F	09/24/2003	24 hours after vaccination (influenza) pt developed low grade fevers (99-100), diffuse joint pain, myalgias, nausea, diarrhea and localized induration and erythema at injection site (4cm x 3cm).				Y					Y	09/22/2003	09/23/2003	1	CBC WNL	PVT	PVT	Zoloft, Orcon, Zyrtec	NONE	Allergic rhinitis			1						1	Arthralgia; Diarrhoea; Injection site erythema; Injection site induration; Myalgia; Nausea; Pyrexia	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0209869	10/01/2003	WV	55.0	55		F	09/25/2003	Rash on forearms, face, legs. Returned to clinic day after injection. Decadron 8mg IM and Benadryl OTC.				Y					U	09/24/2003	09/24/2003	0		OTH	PVT	ASA, Prinizide, HCTZ, Lipitor, Synthroid, Elavil, Toprol	S/P CABG, ASHD, GERD	Allergy to codeine			1						1	Rash	FLU3~EVANS VACCINES~765141~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0209881	10/01/2003	RI	3.0	3		F	09/24/2003	5cm induration, 2cm erythema right anterior thigh. Fever, tremors at site of IPV.									Y	09/23/2003	09/23/2003	0		PUB	PUB		URI				1						1	Injection site erythema; Injection site induration; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U1088AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W0906~5~IM~RL~POLIO VIRUS, INACT. (POLIOVAX)~1|PPV~MERCK & CO. INC.~0675M~UNK~IM~LL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0209965	10/01/2003	WI	30.0	30		M	10/01/2003	I REC'D DURING A HEALTH FAIR AT MY PLACE OF EMPLOYMENT (A YEARLY EVENT) ON 10/12/02.  I HAVE HAD FLU SHOTS FOR THE PAST 2 YEARS.  APPROX. 4 HOURS AFTER RECEIVING THE FLU SHOT, I DEVELOPED A SEVERE DOUBLE VISION PROBLEM.  I VISITED MY EYE DOCTOR SEVERAL TIMES AND HAD A CAT SCAN AND MRI.  THE PROBLEM WENT AWAY ABOUT 2-3 WEEKS AFTER THE FLU SHOT.  RECORDS FOR EXACT VACCINE TYPE WOULD BE AVAILABLE FROM MY EMPLOYER. Medical records state eyes reddened. msv				Y					Y	10/12/2002	10/12/2002	0	DOCTORS' OBSERVATIONS/TESTS, MRI, CT SCAN	UNK	UNK	NONE	NONE	NONE Medical records state allergy, blurred vision. msv			1						1	Conjunctivitis; Diplopia	FLU3~SANOFI PASTEUR~53692HA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0209929	10/02/2003	LA	71.0	70		M		This subject is a 71 year old male who was admitted to the hospital for an exploratory laparotomy and was found to have metastatic adenocarcinoma while enrolled in RSV 11 study. The subject received RSV vaccine or Placebo and Influenza Vaccine on 10/14/02. The subject developed stomach pain and weight loss and 185 days post-immunization on 4/17/03 was admitted to the hospital for an exploratory laparotomy and liver biopsy and was found to have metastatic adenocarcinoma consistent with pancreatic origin. Oncologist recommended palliative chemotherapy. Investigator is awaiting more records and will send when received. Patient was discharged on 4/22/03. Outcome is ongoing. Diagnosis: Metastatic Adenocarcinoma to the liver from the pancreas. The investigator assessed the event as unrelated to the study product. Follow up information received on 5/23/03. MediPort insertion was done on 5/8/03. On the 5/6/03 chemotherapy was initiated with Gemzar, 1000mg IV on day one and day eight, also Xeloda 650mg BID for 14 days. This cycle it to be repeated every 21 days as long as blood counts tolerate. Subject was also started on Pancrease 2 to 3 tablets before meals for indigestion and Duragesic 50mcg every 72 hours for pain relief. Additional information received on 9/24/03. The subject died 344 days after receiving RSV vaccine or Placebo and Influenza vaccine. Death: 9/23/03. The death was reported by the investigator as unrelated to the study vaccine. Further information has been requested.	Y	09/23/2003			Y	5			N	10/14/2002	04/17/2003	185		UNK	UNK	Serevent; Thyroid; Slo-Bid; Flovent; Ambien; Claritin; Viag; Vioxx; ASA; Afrin; Rhinocort; Protonix; Lorate		Mass: body of pancreas		200300447	1						1	Abdominal pain upper; Adenocarcinoma; Weight decreased	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0209941	10/02/2003		43.0	43		F	09/24/2003	Pt received influenza vaccine injection on 9/22/2003. The following morning, 9/24/03 pt noted raised wheal with erythema, urticaria and warmth at the injection site. Reaction subsided as the day progressed and no other problems noted.									U	09/22/2003	09/24/2003	2	NONE	UNK	UNK			NKA. Pt has received influenza vaccine annually for 20+ years without previous reaction.			1						1	Feeling hot; Injection site erythema; Injection site swelling; Urticaria	FLU3~SANOFI PASTEUR~U1144AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210035	10/03/2003	MI	80.0	80		M	10/03/2003	Vaccine administered at approximately 9:45 am.  Approx. 1 hour later patient felt weak, felt like heart was palpitating, had the shakes, was breathing hard and felt faint.  Wife states she took him to ER.  He was discharged with Benadryl and a steroid pack.				Y					Y	10/01/2003	10/01/2003	0	Unsure?	PUB	PVT	?	?	?			1						1	Asthenia; Dizziness; Dyspnoea; Palpitations; Tremor	FLU3~SANOFI PASTEUR~u1102aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210042	10/03/2003	CA	0.0	45		M	10/03/2003	urticaria developed approx 10 hours after exam									Y	09/30/2003	10/01/2003	1		MIL	MIL	none	none	none physician diagnosed			1						1	Urticaria	FLU3~SANOFI PASTEUR~u1098aa~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210044	10/05/2003	DE	37.0	37		M	10/05/2003	15 minutes after vacination of Anthrax and Flu, patient developed macular-papular puretic rash circumflexing his chest and upper extremities.  No angioedema, SOB, respiratory difficulty, or tachycardia.  Alert and orientient X 3, vital signs stable (115/72, 122/80) during entire event.  Only complaint was itchiness.  Given 50mg IM Benadryl and 4mg of Dexamethasone.  After 1/2 hour rash resolving, puritis resolving, and remained stable.  Patient released accompanied by co-worker.									Y	10/05/2003	10/05/2003	0	None	MIL	MIL	None	None	Nothing reported.	None~Anthrax (Biothrax)~2~0.00~In Patient		1						1	Pruritus; Rash maculo-papular; Rash pruritic	ANTH~EMERGENT BIOSOLUTIONS~FAV071~3~SC~RA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~765412~4~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0209988	10/06/2003	GA	67.0	66		M		This subject is a 67 year old male who died at home from Ateriosclerotic Cardiovascular Disease while enrolled in the RSV 11 study with RSV vaccine. The subject received RSV Vaccine or Placebo and Influenza Vaccine on 11/1/02. The subject died from Arteriosclerotic Cardiovascular Disease on 9/13/03, 316 days post immunization. Death Certificate 9/17/03: The cause of death was Arteriosclerotic Cardiovascular Disease. No autopsy was performed. The death was reported by the investigator as unrelated to the study vaccine. A 15-day follow up report received 10/22/2003 adds: Additional info received 10/09/2003. Pt, 67 year old male seen 08/12/2003 in cardio clinic reporting doing well overall, blood sugars were stable, CHF stable with medications. Echocardiography performed on 09/03/2003 revealing marked concentric LVH, marked left atrial enlargement, mild mitral regurgitation, mild tricuspid regurgitation with normal pulmonary pressure. No other info is available as pt died at home and no autopsy performed. Diagnosis: Arteriosclerotic Cardiovascular disease. List of additional info received and available with source file: Death certificate: 9/22/2003. Medication Record: 10/16/2002-08/12/2003. Doctors notes: 08/12/2003. Echocardiography report: 09/03/2003. A 15-day follow up report received 10/23/2003 adds no new info.	Y	09/13/2003							N	11/01/2002	09/13/2003	316		UNK	UNK	Digoxin; Simethicone; Simvastatin; Polyvinyl alcohol; Spironolactone; Losartan; Pyridoxine HCL; Folic Acid; Cyanocobalamin; Insulin Glargine; Isosorbide Dinitrate; Torsemide; Insulin Glargine; Rabeprazole		Patient has history of myocardial infarction, valvular heart disease, congestive heart disease, hypertensive heart disease and diabetes mellitus. On 12/10/02 the patient was admitted to the hospital for chest pain that worsened on ambulation. The patient was diagnosed with angina pectoris (atypical), unknown etiology and was discharged the following day 12/11/02. Patient recovered as of 12/22/02.		200302207	1						1	Arteriosclerosis; Cardiovascular disorder	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0209989	10/06/2003	GA	76.0	75		M		This subject is a 76 year old male, who died at home of carcinoma of unknown primary origin while enrolled in RSV11 study with RSV vaccine. The subject received RSV vaccine or placebo and Influenza vaccine on 10/31/02. The subject died of carcinoma of unknown primary origin on 8/8/03, 281 days post immunization. Death Certificate 8/17/03: The cause of death was carcinoma of unknown primary with ascites and pleural effusion. Approximately interval between onset and death: 5 months. Other significant conditions were COPD, anorexia/malnutrition. The death was reported by the investigator as unrelated to the study vaccine. Further information has been requested. A 15-day follow report received 10/23/2003 adds: Additional info received 10/09/2003. Death occurred at home. Upon researching recent history, 4 additional hospitalizations, SAE's found unreported to site with some medical history and relevance to this will be forthcoming. Reference hospitalization SAE of 7/17-7/23/03 as last medical info available. Pt released in stable condition in care of hospice on 7/23/03. No further data available other than Discharge Summary of 7/23/03. Diagnosis: Carcinoma of UNK primary with ascites and pleural effusion. Cross Reference SAE hospitalization for CHF symptoms 01/05/2003. Hospital Discharge Summary: 07/17-07/23/2003. The pt presented to the Emergency Dept with mental status changes after taking 0.5 mg of Ativan also with a concomitant increase in his Duragesic patch to 50 micrograms. He was admitted for evaluation and continued treatment of his mental status changes and also due to some increase in his shortness of breath and dysphagia type symptoms. A therapeutic paracentesis was performed x2. Due to his dysphagia, speech therapy was consulted for a swallowing evaluation. A barium swallow showed a normal swallowing mechanism. Computed tomographic scan showed air in the esophagus, which was consistent with some sort of mass lesion in the mediastinum, although this was not apparent on the computed tomographic scan done previously. An esophagogastroduodenoscopy was consistent with mild esophagitis, otherwise was WNL without strictures or other obstructions seen. The pt continued to be at his baseline during his hospital stay with no definite etiology of the globus sensation, his dysphagia and swallowing difficulties that the pt was having. He was given no apparent etiology from an esophagogastroduodenoscopy, barium swallow or computed tomographic scan. After discussing the risks and benefits of total parental nutrition and ventral line, the pt declined that therapy at this time. The pt's medications were changed to add Megace, Morphine Sulfate as needed and the pt was instructed to call his Primary Care Provider if his symptoms returned for a repeat therapeutic paracentesis as well as other interventions as needed. Additional info received and available in source file: Medication Record: 10/29/2002-07/24/2003. Death Certificate: 08/17/2003. Discharge Summary: 07/17-07/23/2003.	Y	08/08/2003							N	10/31/2002	08/08/2003	281		UNK	UNK	Clopidogrel; Aspirin Enteric Coated; Carvedilol; Furosemide; Nitroglycerin; Amlodipine; Albuterol Inhalor; Enalapril Maleate; Spironolactone; Megestrol Acetate; Ipratropium Bromide.		Other significant conditions of COPD, anorexia/malnutrition. History of myocardial infarction, CHF, and HTN. Relevant history from previous hospitalizations: On 1/5/03 patient was admitted with dyspnea and chest discomfort associated with CHF 66 days after vaccination. He recovered and was discharged one day later.		200302206	1						1	Ascites; Neoplasm malignant; Pleural effusion	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0210031	10/06/2003	OH	0.58	0	.6	F	10/01/2003	None known. Reported since Fluviron vaccine given 0.25 ml (and not FDA approved) in 4 year old although studied.									Y	09/29/2003			NONE	PVT	PVT	NONE	NONE	NONE			1						1	Medication error	DTAP~GLAXOSMITHKLINE BIOLOGICALS~610A2~3~~LL~DTAP (INFANRIX)~1|FLU3~EVANS VACCINES~765669~1~~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~MERCK & CO. INC.~0025N~3~~LL~HEP B (FOREIGN)~1|HIBV~MERCK & CO. INC.~0025N~3~~LL~HIB (PEDVAXHIB)~1	USA		Influenza
0210046	10/06/2003	OH	29.0	29		F	10/06/2003	24 hrs. after injection I had aches without a fever. That next am (4-6am)I had a low grade fever which was relieved with Tylenol. I continued to have aches again the next day-48 hrs. after injection. I noticed a red raised rash on my right arm from my axilla to wrist that was itchy intermittently. By the next day the rash remained(after treatment with Benadyl)and spread only to one small area on my abdomen-the right side. I recieved the injection in my right arm. The aches were gone by 72 hrs. Rash continues but has not changed in definition.									N	10/02/2003	10/03/2003	1	none requested	PUB	UNK	levoxyl 150mcg multivitamin(advanced natalcare) (maybe one OTC sinus med-generic Walmart brand)	12 days recovering from possible viral illness with symtoms of nasal congestion, cough(productive-yellow sputum), h/a, hoarse voice. At the time of injection only nasal congestion  and occasional cough.	I have Graves disease treated with radioactive iodine-now hypoactive thyroid.  I live in Ohio--we all have sinus related issues during the change of season.	mild aches less than 24hrs.  don't remember which dose it occured.~Influenza (Seasonal) (no brand name)~~27.00~In Patient		1						1	Pain; Pruritus; Pyrexia; Rash erythematous	FLU3~EVANS VACCINES~765670~5~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210048	10/07/2003	WA	56.0	55		M	10/06/2003	10/02 vaccine administered. 10/02 Evening: patient began running fever. 10/03 Patient unable to walk due to dizziness; dyspnea on and off since 10/02. 10/05 Mother thought bloated; gave suppository and he died.	Y	10/05/2003		Y					N	10/02/2003	10/02/2003	0		PVT	PUB	Tegretol; Cough medicine; Phenobarbital; Dilantin	NONE	Severe mental handicap; Obesity; Seizure disorder	Site redness~Influenza (Seasonal) (Fluzone)~~54.00~In Patient		1						1	Difficulty in walking; Dizziness; Dyspnoea; Pyrexia; Unevaluable event	FLU3~SANOFI PASTEUR~U1093AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1093AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0210094	10/07/2003	IN	52.0	52		F	09/26/2003	8 x 8.5 cm erythema and swelling left deltoid at injection site.				Y					Y	09/24/2003	09/25/2003	1	NONE	PVT	PVT	Calcium, Vitamin D	NONE	Erythromycin-rash			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~41074AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210180	10/07/2003	MS	69.0	69		F	10/02/2003	Heart rqate up, red edema at site of vaccination, joint pain began approximately 6-8 hours after injection, saw PMD he prescribed benedryl.  Allergic reaction to shot according to PMD									Y	10/01/2003	10/01/2003	0	none	PUB	PUB	none	none	none		MS03076	1						1	Heart rate increased; Hypersensitivity; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U1094AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1026M~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210184	10/07/2003	NJ	39.0	39		F	10/07/2003	Rash on extremities, maculopapular with erythema and pruritis. Taking Benadryl and topical Benadryl.									U	10/02/2003	10/03/2003	1		UNK	PVT	Allegra D, Singulair, Lexapro, Prinzide, Vitamins	Asthma	Grass, trees, dogs, cats, horses			1						1	Erythema; Pruritus; Rash maculo-papular	FLU3~EVANS VACCINES~765413~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0198576	10/08/2003	GA	21.0	20		M	10/08/2003	Pt has done very well. He denies any on-going cardiac sequelea. He completed a cardiology appointment on 19 August 2003 Cardiology.  He exhibits normal cardiac function as demonstrated by echocardiogram, myocardial perfusion scan and Cardiolyte Exercise Stress Test.			Y	Y	Y				Y	02/05/2003	02/13/2003	8	Test Date/Result  His 6-12 week follow-up should have been completed between 28 March and 05 May 2003, but was not completed secondary to client being TDY.  CKMB 9/15/03 - 0.0   Troponin I Not Done   CPK 9/15/03 - 1025   BNP Not Done         ECG 9/19/03 - Normal Sinus Rhythm W/O ectopy  Echo 9/08/03 - No change from 02/27/03 except decrease in LA size, No effusions or RWMA - LVEF = 58%  Myocardial Perfusion Scan 09/12/03 -No significant motion artifact; soft tissue artifact without evidence of ischemia or previous infarction  Stress Test 9/12/03 - Reach 93% of MPR -  16.3 METS - No chest pain - No significant ST segment Shift seen   9/12/03 - Gated Spec Data = Brisk/symmetrical contractile pattern - EF 53% by QPS/QGS software and 64% by the EC Toolbox software - No focal wall motion abnormalities - NORMAL CARDIOLYTE STRESS TEST	MIL	MIL	None	Strep Throat Developed within 72 hours	None			1						3	Chest pain; Myocarditis; Headache; Myocarditis; Laboratory test abnormal; Nonspecific reaction	FLU3~SANOFI PASTEUR~U0957AA~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020071~1~~~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~U1203~2~IM~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|ANTH~EMERGENT BIOSOLUTIONS~~2~~~ANTHRAX (BIOTHRAX)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|SMALL~PFIZER\WYETH~~1~~~SMALLPOX (DRYVAX)~2|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~2|SMALL~PFIZER\WYETH~~1~~~SMALLPOX (DRYVAX)~3	USA	Life Threatening,Hospitalisation	Influenza
0210124	10/08/2003	NY	37.0	37		F	10/07/2003	9:10 vaccine 0.5 LT deltoid, c/o pain, site w/ 4(+) edema, hand with numbness, tingling, followed by resp distress. 10:05 Benadryl 10:27 solu-cortef 250IV 10:10A epinephine 0.3.			Y	Y					Y	10/06/2003	10/06/2003	0		OTH	UNK	NONE	NONE	PCN-rash			1						1	Hypoaesthesia; Injection site oedema; Pain; Paraesthesia; Respiratory distress; Dyspnoea; Oedema peripheral; Pain; Dysphagia; Laryngeal oedema; Oedema peripheral; Rash	FLU3~SANOFI PASTEUR~U1268AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U12688A~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Life Threatening	Influenza
0210127	10/08/2003	CO	73.0	73		M	10/01/2003	Within less than five minutes aft4er receiving the influenza injection in the left arm I lost most the hearing in the left ear. I used a cell phone before leaving my car in the parking lot and could hear fine. I went into the building, got the shot, returned to my car and tried to use the cell phone again but couldn't understand the other party as the voice seemed distorted or muffled. Prior to this event, I have always had excellent hearing. I have received flu shots for many years probably since they were first available with no reactions. After losing hearing in the left ear I immediately made an appointment with doctor. He conducted test and then referred me to another doctor. He conducted tests, gave me drugs to take and made injections through the ear drum. None of these things helped. The 60 day follow up received on 12/16/03 states loss of hearing in the left ear. This occurred immediately upon receiving the innoculation, 2nd there has been no improvement since then. More info concerning this incident is in the report sent 10/1/03.								Y	N	10/27/2002	10/27/2002	0	Medical record states abnormal lab test. msv	PUB	OTH	NONE	NONE	NONE			1						1	Hearing impaired; Laboratory test abnormal	FLU3~SANOFI PASTEUR~40928B~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0210130	10/08/2003	CA	21.0	21		F	10/06/2003	After being injected with the Evans Flu Vaccine, Lot # 765412, the patient's arm became swollen and ached.  That evening the patient experienced flu like symptoms, i.e. body aches and sore throat.  The MD and a co-worker were also given the same injection and both experienced the same symptoms.									Y	10/03/2003	10/03/2003	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Influenza like illness; Pain; Pharyngolaryngeal pain	FLU3~EVANS VACCINES~765412~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210131	10/08/2003	CA	28.0	28		F	10/06/2003	After being injected with the Evans Flu Vaccine, Lot # 765412, the patients arm became swollen and ached.  That evening the patient experienced flu-like symptoms, i.e. body aches and sore throat.  The MD and a co-worker were also given the same injection and both experienced the same symptoms.									Y	10/03/2003	10/03/2003	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Influenza like illness; Injection site oedema; Pain; Pharyngolaryngeal pain	FLU3~EVANS VACCINES~765412~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210132	10/08/2003	CA	36.0	36		F	10/06/2003	After being injected with the Evans Flu Vaccine, Lot # 765412, the patient's arm became swollen and ached.  That evening the patient experienced flu like symptoms, i.e. body aches and sore throat.  The MD and a co-worker were also given the same injection and both experienced the same symptoms.									Y	10/03/2003	10/03/2003	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Influenza like illness; Injection site oedema; Pain; Pharyngolaryngeal pain	FLU3~EVANS VACCINES~765412~UNK~IM~GM~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210143	10/08/2003	HI	19.0	19		M	09/29/2003	Pt with fever, chills, viral protrome. Requiring quarters for 24 hours.									Y	09/25/2003	09/27/2003	2	Throat culture	MIL	MIL		NONE	NONE			1						1	Chills; Pyrexia	FLU3~PFIZER\WYETH~765141~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|SMALL~PFIZER\WYETH~4020074~1~~~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~W1366~1~IM~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0210150	10/08/2003	NY	65.0	65		F	10/07/2003	Severe body aches with onset on evening of 10/06.  Also experienced transient spasms around the right knee.  Pain was not relieved by Tylenol and Ibuprofen last night.  Patient could not reach her PMD on 10/07.  Symptoms now lessened but patient still sore in vaccinated arm.  Body aches much decreased.  No knee spasms.									N	10/06/2003	10/06/2003	0	NONE	PUB	PUB	Temomin 25 mg/day	NONE	Left breast masectomy (1983 or 1984), arthritis			1						1	Muscle spasms; Pain	FLU3~SANOFI PASTEUR~U1088AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0710M~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210188	10/08/2003	MS	81.0	80		M	10/03/2003	Wife called clinic 10/03/03.  Reports 2 and half hours after flu vaccine patient c/o, n/v, bpv.  Symptoms not improved next day, instructed patient to see PMD ASAP.  Patient went to hospital from residence 10/4/03 via ambulence, expired that night.	Y	10/04/2003							N	10/02/2003	10/02/2003	0	na	PUB	PUB	none	cancer, severe anemia	see 18		MS 03  077	1						1	Nausea; Vertigo; Vomiting	FLU3~SANOFI PASTEUR~U1271AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0210214	10/08/2003	TX	29.0	28		F	10/08/2003	Itching on face/ears/mouth/buttocks and arms/hands started 5 minutes after injection.  Shortness of breath, itchy eyes, crying, dizziness and voice pitch changed started 20-30minutes after injection. Took tylenol.									Y	10/06/2003	10/06/2003	0		PVT	PVT		None	none	flu like symptoms~Influenza (Seasonal) (no brand name)~1~92.80~In Patient		1						1	Crying; Dizziness; Dysphonia; Dyspnoea; Pruritus	FLU3~EVANS VACCINES~765499~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210217	10/08/2003	MT	58.0	58		F	10/08/2003	Chills and fever within 3 hours of vaccination, temperature reached 101 degrees F.  Sore arm but no swelling or redness at site.  No upper respiratory symptoms.  Dull headache, body aches.  No GI problems or rash.  Temperature normal this morning at 7 AM.  Body aches gone, but still has headache and feels blah.									Y	10/07/2003	10/07/2003	0	None	UNK	UNK	Inderal, depakote, vioxx, OTC antihistamine	None	diabetes (no meds), migraines, allergic to HCTZ, sulfa, and IVP dye.	Severe redness and swelling at injection site~Influenza (Seasonal) (no brand name)~~0.00~In Sibling		1						1	Chills; Headache; Injection site pain; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1070AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210190	10/09/2003	AZ	83.0	82		F		This subject is an 83 year old female, who was admitted to hospital due to acute renal failure while enrolled in RSV11 study. The subject received RSV Vaccine or Placebo and Influenza Vaccine on 10/22/02. The subject developed generalized weakness, low grade fevers, low intake and decreased urinary output for 24 hours and was brought to the emergency room by the family on 7/25/03, and was admitted to hospital on 7/25/03, 276 days post immunization. She was diagnosed with renal failure which was thought to be superimposed on an underlying chronic renal failure. Treatment included IV fluid with infusion of normal saline and put on oral fluid restriction to one liter per day and Lasix was hold. The subject's hyponatremia recovered and dehydration was resolve with IV infusion. During her admission it was suspected that she had Parkinsonism. She was started on a low dose Sinemet to be followed up by the primary care physician. Discharge diagnosis: Hyponatremia recovering, Suspicion of Parkinsonism, History of coronary artery disease, stable, Acute renal failure secondary to dehydration superimposed on chronic renal failure, Dehydration, resolved, Diabetes Mellitus, on insulin, Hypertension controlled, Mild chronic anemia of chronic disease. After subject was stable she was discharged home for hospice home care visits. While at home she got a severe upper respiratory infection. Subject and family only wanted good comfort interventions. The subject expired on 9/28/03 at home. The event was reported by the Investigator as unrelated to the study vaccine. Additional information received and available in the source file: History and Physical for admission 7/25/03, Discharge Summary for 7/25 to 7/27/03, Summary of Lab tests from 5/31/02 to 7/27/03, Chest X-ray 7/25/03, Hospital Discharge Notification, Hospice Plan of Care 9/1/03, Hospice Physician Admission Orders 9/1/03. A 15-day follow up report received 10/22/2003 adds no new info. A 15-day follow up report received 10/23/2003 adds: Additional info received 10/07/2003. Subject was a hospice pt. No autopsy was done. Confiemed that pt wasn't hospitalized on 09/08/2003. 10/17/2003: No further info is anticipated, case is closed.	Y	09/28/2003			Y				N	10/22/2002	07/25/2003	276	Glucose 245, BUN 27, Sodium 127, Potassium 3.8, Chloride 93, Bicarbonate 26, Creatinine 1.8. The rest of the comprehensive metabolic profile is within normal range. Complete blood count revealed white blood cell count 11.2, Hemoglobin 10.9, Hematocrit 32.2, MCV 94, and Platelets 243,000. Urinalysis with micro is normal. Basic metabolic profile on discharge, glucose 151, blood urea nitrogen 21, sodium 134, potassium 4.0, chloride 104, total bicarbonate 26, creatinine 0.3, calcium 8.0, and magnesium 1.6. Prior to her discharge, the subject on 2g of magnesium sulfate IV infusion). CBC: WBC 11.2, hemoglobin 10.9, hematocrit 33.2, mean corpuscular volume 94, platelet 243. Cardiac enzymes were negative. Urinalysis, protein +2 and nitrates and leukocyte esterase are negative. White blood cell is only 224.	UNK	UNK	Potassium Hydralazine; Ranitidine; Isosorbide mononitrate; Macrobid; Atenolol; Quinine sulfate; Sinemet; Lasix; Insulin; Imdur; ASA; Synthroid		Patient has a history of congestive heart failure, hypertension, angina, coronary heart disease, stent placement and angioplasty, left ventricular dysfunction, hyperlipidemia, diabetes type II, chronic renal failure, mild anemia, degenerative joint disease, hypothyroidism. Allergies: Penicillin, Sulfa.		200302227	1						1	Asthenia; Dehydration; Hyponatraemia; Laboratory test abnormal; Oral intake reduced; Pyrexia; Renal failure; Urine output decreased	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0210195	10/09/2003	WA		61		U		Rash, itching 1 day post treatment.  Patient went to MD-received prescription for cyproheptadine 4 mg 2 times daily.									U	09/30/2003	10/01/2003	1	NONE	OTH	PUB	Tricor 160 mg; Atenolol 50 mg; Norcase 5 mg; Prolenix 20 mg; allganinol 300 mg;	NONE	Hyperlipidemia; Hypertension; Gout			1						1	Rash pruritic	FLU3~SANOFI PASTEUR~U1256AA~5~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210205	10/09/2003	IN	88.0	87		F	10/07/2003	At 16:00 on 10/06/2003, patient noticed soreness in left arm.  About 20:00 she noticed left arm was warm to touch and swollen.  Unable to sleep off discomfort of arm.  Today 10/07/2003, evident edema from just above anticubital space extending to about 6 inches below left shoulder.  Generalized redness and warmth.  No lumps, knots, or bruises noted.  Able to use left hand.  No numbness or tingling noted.									U	10/06/2003	10/06/2003	0	NONE	OTH	PVT	Potassium, Lotrel	NONE	NONE			1						1	Erythema; Feeling hot; Oedema; Pain	FLU3~EVANS VACCINES~765688~UNK~ID~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0257N~UNK~ID~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210207	10/09/2003	CA	63.0	63		F	10/08/2003	Patient states: I woke up at 03:00 with a charlie horse in my right leg and it got worse and now it is in my right arm.  difficulty moving.				Y					U	10/07/2003	10/08/2003	1	NONE	PVT	PVT	ZOCOR	TENDONITIS	TENDONITIS			1						1	Hypokinesia; Muscle spasms	FLU3~SANOFI PASTEUR~U1137EA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210259	10/09/2003	GA	68.0	68		F	10/09/2003	Late Tuesday afternoon, patient started having pain at injection site of pneumonia vaccine. Patient has swelling, reddness, and heat to affected site. Swelling in the inner aspect of left upper arm.  Patient is unable to abduct left arm. Appointment scheduled for patient with her PCP today at 11:30 a.m.				Y					Y	10/07/2003	10/07/2003	0		PUB	UNK		none	nkda			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~EVANS VACCINES~765707~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0564N~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210262	10/09/2003	GA	67.0	67		F	10/09/2003	On the afternoon of immunization, patient experienced pain at the site of pneumococcal vaccine which progressed to swelling and reddness with heat.  Swelling, reddness, and heat extends from axillary to wrist of left inner arm. Client notified MD day of onset and was instructed to take benadryl.  Client called today and instructed to come in for assessment.  Inner aspect of left arm with reddness from elbow to wrist, noted hot to touch and swelling. Client is post polio patient with residuals in this arm. Appointment made with MD to be seen today.  Per MD office will call client with appoint time.  Client instructed to call this nurse after visit with MD.  Will follow up with client on Monday.				Y					Y	10/07/2003	10/07/2003	0		PUB	UNK		none	nkda post-polio			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~EVANS VACCINES~765707~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0564N~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210265	10/09/2003	IL	0.0	31		F	10/09/2003	uticaria near site of immunization, inflammed axillary lymph node.				Y					Y	10/07/2003	10/09/2003	2		PVT	PVT	Synthroid Effexor Prenatal Vitamins	6 wks post partum	Allergy to penicillin			1						1	Lymphadenopathy	FLU3~SANOFI PASTEUR~U1144AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0257N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210267	10/09/2003	FL	53.0	53		F	10/09/2003	Less than 24 hours after vaccine administration of 10/7/03, client describes severe headache like no other before. Pulse 68, B/P 144/94, Temp 97.7, c/o photosensitivity. Referred to Emergency Room, CT head negative,tx with pain medications, scheduled for MRI 10/10/03				Y					Y	10/07/2003	10/08/2003	1	CT head negative	PUB	PUB	Premarin	None	none			1						1	Headache; Photosensitivity reaction; Pyrexia	FLU3~SANOFI PASTEUR~U1081AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0193006	10/10/2003	CO	26.0	26		F	10/07/2003	A VAERS report received concerning a 26 year old female who was administered an influenza vaccine (manufacturer and lot number not reported) on 11/7/02. It was reported, 10 minutes after the flu shot patient complained of warmth in her total body. Patient became dizzy and felt like her hands were swelling. Patient became nauseated and then vomited. She then felt like her airway was closing. RN evaluation found the patient vomiting, face flush, heart rate 144, and respiration rate 22. Benadryl 50mg PO given per standing orders. 911 called due to patient's describing the feeling her throat were swelling. No acute respiratory distress evident. Vital signs recheck P 92, R 20, BP 132/100. Paramedics arrived and transported patient to hospital ED for evaluation. Patient evaluated and released on 11/8 with diagnosis of allergic reaction. Patient was recovered on 11/10 at 5 PM. She is doing fine. Last vaccine was 8 weeks ago. No other vaccines in the last 4 weeks. She is allergic to chicken feathers. From additional information received on 10/3/03, it was confirmed by the initial reporter that the patient received FLUZONE SV 2002-2003 USP, lot number U0920AA, administered IM in the left deltoid. The reporter also stated that the patient was sent to ER and had an acute allergic reaction to the flu shot, and this could be related to feathers. The reporter also stated that there is a history of allergies to various medications, but she did not have a listing of them. A fax number and contact person was provided for the medical records department. A release of information was requested from medical records. From additional information received on 10/6/03, the time of onset was clarified. It was also noted that the patient got a very red, itchy arm at the site of vaccination. Medical history and allergy information was provided. A copy of the emergency department record was also provided. At the time of the patient's admission to the emergency department the patient was awake and alert, normal mentation. Vitals were stable. Patient was afebrile. Room air sat of 91%. There was no redness around the injection site and no other hives or rash. There was no angioedema. Oropharynx examination was normal. Lungs were clear, work of breathing normal. Heart rhythm was regular, no murmur or rub. (OMIC)				Y					Y	11/07/2002	11/07/2002	0		PUB	PVT	Nexium; Unspecified inhaler	NONE	She is allergic to chicken feathers. From additional info received on 10/6/03: Pt is allergic to PCN, Bactrim, codeine, Keflex, Sudafed, sulfa, Ultram and Vicodin. Pt has a history of anemia, tibal ligation, asthma and some esophageal reflux.		U200201043	1						2	Dizziness; Heart rate increased; Hypersensitivity; Injection site erythema; Injection site hypersensitivity; Nausea; Oedema peripheral; Pharyngeal oedema; Pruritus; Vomiting	FLU3~SANOFI PASTEUR~U0920AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0210048	10/10/2003	WA	56.0	55		M	10/01/2004	From initial information received on 10/6/03 from a pharmacist, regarding a death occurring in the USA, it was reported that a 55 year old male patient died three days after receiving a dose of FLUZONE, lot numberU1093AA (route/site not reported) on 10/2/03. The patient died on 10/5/03. the reporter will fax the completed report at a future date. Follow up on 10/20/2003: From additional information received on 10/09/2003, through a telephone call from the reporting pharmacist, it was stated that no VAERS report will be faxed to AvP and any information can be obtained from the FDA.  A completed VAERS report was sent to the FDA and they have been in contact with the FDA by phone.  It was also stated that preliminary reports show no cause from flu vaccine.  A 15-day follow up report received 10/20/2003 adds no new info. 16Jan04: No further information is anticipated, this case is considered closed. No relevant additional information is provided for the adverse experience; this specific information is not submitted to health authorities.	Y	10/05/2003							N	10/02/2003	10/05/2003	3		UNK	UNK					200302250	1						2	Difficulty in walking; Dizziness; Dyspnoea; Pyrexia; Unevaluable event	FLU3~SANOFI PASTEUR~U1093AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1093AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0210248	10/10/2003	MA				U		Patient complained of a sting upon injection and red and sore around the site.  Patient called 10/03/2003 at 14:00.									Y				NONE	OTH	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site pain; Pain	FLU3~SANOFI PASTEUR~U1253AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210257	10/10/2003	TX	43.0	43		F	10/09/2003	L arm site pain with point tenderness at perimeter of deltoid muscle. Onset 24 hrs post injection. A follow up report received 10/23/2003 adds: Diagnosed as deltoid bursitis related to the tetanus vaccination per Dr. Rx with Vioxx, rest, has not lost work.				Y					U	10/01/2003	10/02/2003	1		PUB	PVT	Zestoretic, Prilosec	NONE	Allergic to codeine/Reglan			1						1	Bursitis; Injection site pain; Tendon disorder	FLU3~SANOFI PASTEUR~U1074AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0845AA~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0210269	10/10/2003	PA	33.0	33		F	10/10/2003	12:30 AM 10/10/03 patient woke with fever 103 F, shaking chills, and severe myalgia especially of vaccine site but also other major muscle groups.  7:00 AM 10/10/03 patient attempted to stand, developed acute onset pounding headache, dizziness,nausea and tinnitus - unable to walk or stand due to symptoms 7:45 AM 10/10/03 patient obtained glass of water and 600 mg ibuprofen 9:00 AM 10/10/03 fever down to 99.7 F, patient feeling much better. Still sore and dizzy, but able to function.									U	10/09/2003	10/10/2003	1		UNK	UNK	none	none	allergic airway disease, atopy, penicillin allergy, migraine			1						1	Abasia; Chills; Dizziness; Headache; Myalgia; Nausea; Pyrexia; Tinnitus; Tremor	FLU3~SANOFI PASTEUR~U1141AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210270	10/10/2003	IN	30.0	30		F	10/10/2003	Approximately 3 hours after vaccination patient was urinating - arose from the toilet and passed out (was in her daughter's hospital room - elective admission for IVIG).  Had felt well before - no prodromal symptoms.  Found pulseless - required CPR and intubation.  Extubated and well 2 hours later.  Patient had history of multiple ICU admissions for severe asthma, opiate withdrawl and prior syncope attributed to SVT.  NO rash, wheezing, angioedema seen during event.			Y	Y	Y	3			Y	10/09/2003	10/09/2003	0	None known to me.	PVT	PVT	Many - do not know list	Was well - out of ICU for 3 weeks	No history of allergies to eggs or antibiotics.			1						1	Asthma; Loss of consciousness; Pulse absent; Syncope	FLU3~SANOFI PASTEUR~U1253AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0210323	10/10/2003	CO	66.0	66		F	10/10/2003	Malaise within 5 hours, low fever within 12 hours,high fever (102.5) within 20 hours, headache, joint pain. Itching. Rx-Allegra, chlortremiton, calomine lotion.									U	10/08/2003	10/08/2003	0		PUB	PUB	Allegra   Synthroid Effexor    Nasonex	none	Allergies:  pollens, peanuts, watermelon, corn			1						1	Arthralgia; Headache; Malaise; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~UI069AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0256N~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210324	10/10/2003	MS	73.0	73		F	10/06/2003	Client in today to report local reaction from pneumococcal vaccination given 10/03.  Rt forearm today with erythema, redness swelling and warm to the touch.  Patient reported feeling bad and fatiqueed.  Saught tx from PMD									Y	10/03/2003	10/03/2003	0	none	PUB	PUB	none	none	none		MS03078	1						1	Fatigue; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1094AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0872M~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210326	10/10/2003	TX	12.0	12		M	10/10/2003	Mother states that around noon on Thursday, 10/9/03 her son had red, itchy blotches on his face and torso.  She used some cortisone spray to help relieve the symptoms.  Later in the evening around 9:00 to 9:30 p.m., the itching had gotten worse and she went next door to get some Bendadryl.  By the time she got back, his face appeared very red and blotchy, which appeared to be hives.  She called a minor emergency clinic at 10:00 pm, but the doctor had already left; the nurse told the mother to take her son to the hospital emergency room.  The parents took him to Hospital.  By the time they arrived the benadryl had started working and some of the symptoms had decreased.  Did not have any respiratory symptoms.  They treated him for an allergic reaction.  I spoke with the mother and recommended that she call her son's medical provider to inform her of the reaction.				Y					Y	10/08/2003	10/09/2003	1		PUB	PVT	Takes .25 cc of Saizen (growth hormone) 6 days/week, also takes 25 mg. of Strattera for ADD 1 capsule every day.	No illness.	Cleft palate and scoliosis.			1						1	Erythema; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1140AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210327	10/10/2003	NY	32.0	32		F	10/10/2003	PT REPORTED VAGINAL SPOTTING TODAY. DENIES S/SX OF UTI. MENSTRUAL PERIOD DUE IN ABOUT A WEEK AND A HALF. NOT COMMON FOR PT. TO SPOT. PT. GIVEN FEMININE NAPKIN									Y	10/09/2003	10/10/2003	1	N/A	UNK	UNK	BIRTH CONTROL PILLS	NONE	NONE			1						1	Vaginal discharge	FLU3~EVANS VACCINES~765413~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~SANOFI PASTEUR~U0839AA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0210329	10/12/2003	CA	56.0	56		M	10/12/2003	Hoarseness									Y	10/11/2003	10/11/2003	0		UNK	PVT	Synthroid, Wellbutrin SR, Singulair					1						1	Dysphonia	FLU3~SANOFI PASTEUR~U1256AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210283	10/13/2003	MO	18.0	18		F	10/09/2003	Redness, warmth, swelling, pain around vaccination site right shoulder. Fever, malaise, aches, fatigue.									U	10/07/2003	10/07/2003	0		PVT	OTH	Wellbutrin, Peg-intran, Reddatol	NONE	Hepatitis C, depression			1						1	Fatigue; Feeling hot; Injection site erythema; Malaise; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1142AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0257N~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210284	10/13/2003	LA	65.0	65		F	10/10/2003	Vaccination given 10/6/03 LD. ER visit on 10/7/03 with c/o pain, swelling, bruising. Given cephalexin, Darvocet, Benadryl. Return to clinic 10/7/03 PM, given Decadron and Prednisone 30 qd x10. 10/8/03 improving. 10/10/03 swelling lower with extensive bruising.				Y					Y	10/06/2003	10/06/2003	0	NONE	PVT	PVT	NONE	NONE	NKDA, CVA 1995 recovered, TAH 1979			1						1	Contusion; Injection site oedema; Pain	FLU3~SANOFI PASTEUR~U1267AA~3~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1119M~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210306	10/13/2003	MD	57.0	57		F	10/07/2003	Burning at site with swelling 9.5 cm by 6 cm.									U	10/06/2003	10/07/2003	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site oedema; Skin burning sensation	FLU3~EVANS VACCINES~765178~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210314	10/13/2003	CA		3		M	10/09/2003	Febrile illness, flu-like illness									N	10/07/2003			NONE	OTH	OTH	NONE	NONE	NONE			1						1	Influenza like illness; Malaise	FLU3~SANOFI PASTEUR~U1139AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210315	10/13/2003	CA		2	.0	F	10/09/2003	Febrile illness, flu-like syndrome?									N	10/07/2003			NONE	OTH	OTH	UNK	UNK	UNK			1						1	Influenza like illness; Malaise	FLU3~SANOFI PASTEUR~U1139AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210316	10/13/2003	PA	41.0	41		F	10/10/2003	Patient states hives on body.  Not seen by MD or nurse.  States received flu vaccine on 10/18/2003.  Patient referred assessment by nurse and MD-walked out of clinic while attempting to complete form.									U	10/08/2003	10/08/2003	0	NONE	PUB	OTH	NONE	NONE	Seasonal allergies (zyrtec)			1						1	Urticaria	FLU3~EVANS VACCINES~765414~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210317	10/13/2003	NY	36.0	36		F	10/10/2003	No swelling. Pain at site of injection that progressed along entire arm and down to wrist.  No fever.									N	10/10/2003	10/10/2003	0	NONE	PUB	PUB	Depo-Provera; Flonase; Zyrtec	NONE	Allergic (cat, dog, grass, mold), eczema			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U1088AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210337	10/13/2003	TN	4.0	4		M	10/13/2003	Large area of swelling in right arm with extention to elbow and shoulder, are warm. Whitish color surrounding area of vaccine administration, clear fluid at site of injection. Began 1 day after injection, not improved after 24hours of benadryl, zyrtec,and cold compress. Added Augmentin after day 2 of reaction worsening				Y					U	10/08/2003	10/09/2003	1		PVT	PVT			Allergy to peanuts			1						1	Injection site oedema	FLU3~SANOFI PASTEUR~u1255aa~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210340	10/13/2003	IN	30.0	30		M	10/13/2003	Approximately 5-10 minutes following injection I became extremely dizzy and lightheaded and was unable to see clearly.  Voices were muffled and seemed distant.  My family helped me into our home where I lied down for approximately 20-30 minutes.  After that time, I was still stomewhat lightheaded but was beginning to feel somewhat better.  I have received flu vaccination for the past 8 years and have never had any experience remotely similar.									Y	10/13/2003	10/13/2003	0		PUB	UNK	Propecia	None	Allergic to Penecillin			1						1	Dizziness; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0210330	10/14/2003	CA	74.0	74		F	10/13/2003	Had flu vaccine 100303. C/O N & V after vaccine. Deceased 100703 AM cause of death not known. The autopsy report states cardiac arrhythmia and hypertensive heart disorder. Medical Record received on 10/20/2003 states gastritis.	Y	10/07/2003							N	10/03/2003				PVT	UNK						1						1	Arrhythmia; Gastritis; Hypertension; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0210417	10/14/2003	NC	6.0	66		M	10/14/2003	Muscular aching, diahrea and nausea for 2 1/2 days.									Y	10/08/2003	10/11/2003	3		UNK	UNK		None	None			1						1	Diarrhoea; Nausea; Psychomotor hyperactivity	FLU3~SANOFI PASTEUR~V1268 AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210423	10/14/2003	TN	58.0	58		F	10/14/2003	patient came into clinic 10/8 for follow up of hypertension, diabetes.  No symptoms reported.  Agreed to take influenza vaccine.  Medical resident who saw her was call by the medical examiner the next day.  she was found dead in bed by family.  Apparently c/o soreness at injection site; no other symptoms.  Medical examiner signed case out as hypertensive cardiovascular disease, but only did external exam, not full autopsy. The autopsy states hypertensive cardiovascular dx.	Y	10/09/2003							N	10/08/2003	10/09/2003	1	none	UNK	UNK	lisinopril	none	hypertension h/o pneumonia diet controlled diabetes smoker			1						1	Cardiovascular disorder; Injection site pain	FLU3~EVANS VACCINES~765705~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0210426	10/14/2003	MN	28.0	28		F	10/14/2003	Numerous erythematous hives with edema on trunk and upper extremities.   Treatment- Epinephrine-SQ, Benedryl, Prednisone, Atarax				Y					Y	10/08/2003	10/08/2003	0		PUB	PUB		none	Aspirin			1						1	Oedema; Rash erythematous; Urticaria	FLU3~EVANS VACCINES~765669~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~SANOFI PASTEUR~UO841AA~4~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0210349	10/15/2003	NY	57.0	57		M	10/14/2003	1-2 hours after vaccine, complaints of flushing, being hot, weakness through day 4. 10/12/03 shortness of breath, chest tightness. Rx Benadryl, Epi and Solucatf IV. Discharged home. Returned to clinic 10/12; admitted with shortness of breath, my throat is swelling, Epi, Benadryl. Solumedrol and hospitalized.			Y	Y	Y				N	10/11/2003	10/11/2003	0	Blood culture	OTH	OTH	Ceftriaxone; Azithromycin; Simvastatin Tab; Gabapentin Cap; Divalproex; Fosinopril; Trazodone; Magnesium Oxide; Rofecoxib; Ranitidine; Warfarin; Prednisone; Albuterol; Ipratropium;	NONE	NKA			1						1	Asthenia; Chest discomfort; Dyspnoea; Feeling hot; Hot flush; Pharyngeal oedema; Pharyngeal oedema; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U1268AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation	Influenza
0210350	10/15/2003	IA	62.0	62		F	10/08/2003	Day after injection site was tender to touch. Second day after it was red and feverish under the site. More tender to touch and itchy.									Y	10/06/2003	10/07/2003	1	NONE	PVT	PVT	Aldactone, Quinamm, Ibuprofen, Vit C, niacin, K-Dur, folic acid, Vit E, Centrum, Cal w/Vit D, Paxil, Excedrin Migraine, Tagamet, Vit B6, Depo-Estradiol, Provera, Diflucan, Fiorinal	NONE	Allergies: sulfa, Darvon, Amerge and any Triptan migraine medication, tetanus vaccine, flu vaccine. Physiological murmur; history of ulcers; HBP; hyperlipidemia; gastritis and erosions; some hearing loss; menopausal syndrome; chronic sinusitis; rheumatic fever?; hypokalemia; iron def anemia; onychomycosis; family hx osteoporosis; chronic yeast inf; osteopenia; migraine headache; left cataract surgery with intraocular implant; ben endometrial biopsy	redness~Influenza (Seasonal) (Fluzone)~~56.00~In Patient		1						1	Injection site erythema; Injection site warmth; Pain; Pruritus	FLU3~EVANS VACCINES~765484~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210351	10/15/2003	GA	26.0	26		F	10/08/2003	10/7: Awakened with lower arm pain. 10/8: lower arm swelling with redness and increased heat also red, splotchy area over injection site in upper left arm (deltoid). Saw private MD who stated probably allergy reaction and prescribed prednisone.				Y					Y	10/06/2003	10/07/2003	1	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Hypersensitivity; Injection site erythema; Injection site oedema; Injection site warmth; Pain; Rash maculo-papular	FLU3~EVANS VACCINES~765707~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0210352	10/15/2003	NH	64.0	64		M	10/07/2003	Injection given about 10 AM, sx began about 8-10 hours later with left sided facial swelling, numbness, swollen cervical (L) glands, tenderness, swelling improved by following morning (?) also improved.									U	10/06/2003	10/06/2003	0	NONE	PVT	PVT	Celebrex, Ambien, Lipitor, HCTZ, ASA, Altace, Betapace, Tetracycline	NONE	NKDA; HTN, PAF, BPN, recurrent UTI, hyperlipidemia, OA			1						1	Face oedema; Hypoaesthesia; Lymphadenopathy; Pain	FLU3~EVANS VACCINES~765484~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210353	10/15/2003	VA	1.0	1	.0	F	10/09/2003	4cm x 2cm area of redness and swelling around area of injection with warmth. Instructed to apply warm compress and observe. To return to office if worsening of Sx. The follow up received on 10/16/03 states left thigh (Prevnar site) problem area.									U	10/07/2003	10/08/2003	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Feeling hot; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1097AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~492396~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0336N~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0210354	10/15/2003	FL	36.0	36		M	10/01/2003	Pain, fever, within 48 hours. Vomiting at 72 hours.				Y					Y	09/25/2003	09/27/2003	2	NONE	PVT	PVT	NONE	NONE	Psoriasis			1						1	Pain; Pyrexia; Vomiting	FLU3~EVANS VACCINES~765495~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0210355	10/15/2003	NY	55.0	55		M	10/07/2003	Localized soreness immediately after shot. Within 48 hours exhibited soreness in joints and fatigue not related to any other possible causes.									Y	10/04/2003	10/06/2003	2	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Arthralgia; Fatigue; Pain	FLUX~UNKNOWN MANUFACTURER~765141~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0210356	10/15/2003	GA	31.0	31		F	10/06/2003	Left eyelid angioedema about 3 hours after vaccine administration.				Y					Y	10/06/2003	10/06/2003	0	NONE	PVT	OTH		NONE	Diabetes, increased cholesterol, childhood asthma			1						1	Angioneurotic oedema	FLU3~EVANS VACCINES~765703~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0210357	10/15/2003	NY	49.0	49		M	10/06/2003	Symptoms onset within hours of receiving vaccine, complained of: ache at shot site, arthralgias, malaise, fatigue, ?fever/chills (temp not checked), lymph nodes tender and swollen, nausea, vomiting x1, missed work 3 days.				Y					Y	10/03/2003	10/03/2003	0	NONE	PVT	OTH	ASA, Atenolol, Levotmyroxin, Lipitor	NONE	CAD, increased cholesterol, hypothyroid, smoker			1						1	Arthralgia; Fatigue; Lymphadenopathy; Malaise; Nausea; Pain; Pyrexia; Vomiting	FLU3~EVANS VACCINES~765178~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1196M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210358	10/15/2003	IL	78.0	78		F	10/14/2003	Stated she had redness and swelling from shoulder to elbow of right arm beginning Friday PM 10/10/03 and continuing through Saturday 10/11/03. Applied ice packs to area.									Y	10/10/2003	10/10/2003	0		PUB	UNK		NONE				1						1	Injection site erythema; Injection site oedema	FLU3~EVANS VACCINES~765712~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0256N~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210376	10/15/2003	TN	70.0	70		M	10/10/2003	Silver-dollar size, red and swollen around site.									U	10/08/2003	10/09/2003	1		PVT	PVT		NONE	Hypertension, depression			1						1	Injection site erythema; Injection site oedema	FLU3~EVANS VACCINES~765667~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0873M~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210391	10/15/2003	NJ	41.0	41		M	10/04/2003	Local swelling and local itching concerned for potential allergy.				Y					Y	10/04/2003	10/04/2003	0		MIL	UNK	PPD					1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~SANOFI PASTEUR~765412~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210392	10/15/2003	MI	87.0	87		F	10/07/2003	10/3/03 ER report-acute allergic reaction, erythema face, edema eyelids x 1 week. ER meds: Solumedrol IM, Benadryl. 10/7/03 PC from hospital.				Y					Y	09/25/2003	09/26/2003	1		PVT	OTH	Elavil x 4; Warfarin; Bebimax; Clonedien	NONE	NONE			1						1	Erythema; Eyelid oedema; Hypersensitivity	FLU3~EVANS VACCINES~765180~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0210395	10/15/2003	WI	26.0	26		M	10/06/2003	C/O nausea, vomiting, neck stiffness, fever and red swollen arm. A follow up report received 10/22/2003 adds: left arm involved, cough. No temp. Vitals WNL. No intervention.				Y					Y	10/01/2003	10/05/2003	4		PVT	UNK	Proventil, Albuterol	NONE	Asthma			1						1	Cough; Erythema; Musculoskeletal stiffness; Nausea; Oedema peripheral; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1136AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0820M~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TTOX~SANOFI PASTEUR~U0839AA~UNK~IM~RA~TETANUS TOXOID, ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0210396	10/15/2003	MI	1.0	1	.0	F	10/02/2003	Local erythema and induration.									Y	09/22/2003	09/22/2003	0	NONE	PVT	UNK		NONE	Egg allergy			1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U1068AA~1~ID~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0538N~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0210411	10/15/2003	CO		67		U		Vaccine received 14:00, 10/07.  Severe muscular pain down left side if back and left leg felt very tired at 14:30 (10/08).  Very runny, stuffy nose, could not breathe afternoon and all evening.  All night went to MD 10/09 @ 11:00.				Y					N	10/07/2003	10/08/2003	1	BP: 190/90, Sinus problem, Urinalysis: blood in urine	PVT	OTH	Prednisone, Prevachol, Actinol, Protonix, Flovent	NONE	Estrogen, Pine, Immuran, Sjodrens, RA, BOOP, Syndrome	muscle pain~Pneumo (no brand name)~~66.00~In Patient		1						1	Blood urine; Dyspnoea; Myalgia; Nasal congestion; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1091AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210412	10/15/2003	LA	71.0	71		F	10/14/2003	Started with hurting underneath of left arm, then radiating top of arm, into shoulder with weakness.  Big night tume pain into neck.  Next day pain behind hear and dull headache.  Treatment: observe.				Y					U	10/08/2003	10/08/2003	0	as of 10/14/2003 still with some pain.	PVT	PVT	Atenolol, Protonix, Ansaid, Cortor, Detrol, Lasix pm	NONE	HTN, Arthritis, GERD, Urinary incontinence, leg cramps.			1						1	Asthenia; Headache; Pain	FLU3~SANOFI PASTEUR~U1142AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0068N~2~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210413	10/15/2003	LA	51.0	51		F	10/13/2003	Hives on forehead, head and trunk.  Mild headache.  Used Benadryl over the counter.									U	10/13/2003	10/13/2003	0	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Headache; Urticaria	FLU3~EVANS VACCINES~765138~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210530	10/15/2003	PA	38.0	38		F	10/15/2003	Cold, sweat, nausea, significantly elevated blood pressure, dizziness, faint, variable temperature.				Y					Y	10/14/2003	10/14/2003	0		UNK	UNK	Clarinex, Nasacort, Astelin, Prempro (low dose)	N/A	Latex allergy			1						1	Dizziness; Feeling cold; Hyperhidrosis; Hypertension; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0210531	10/15/2003	MI	43.0	43		F	10/15/2003	Have hives on forearms, top of right leg, couple on stomach and couple on left leg at the top. May have some in hair.  Dizzy feeling.									Y	10/08/2003	10/11/2003	3	Vaccine manufacturer wasn't listed.  It was ASD-emerisource bergen specialty group. exp date 6/2004 per Hospital.	UNK	UNK						1						1	Dizziness; Urticaria	FLUX~UNKNOWN MANUFACTURER~765499~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0210533	10/15/2003	CA	56.0	56		F	10/15/2003	Severe burning, aching pain in entire shoulder area 30 minutes following injection given high in left shoulder at 5:00pm 10/13/03. Took acetamenaphen with codeine at 6:00pm, with very little relief. By midnight, slightly improved but extremely sore in shoulder area, unable to lift arm. After approximately 54 hours, severe relapse with constant burning, aching pain in entire shoulder joint area and stiff neck. Two days post-injection, cannot lift injection site arm. However, no visable inflamation or swelling present. Mild to moderate general body aches and headache starting 18 hours post-injection and continuing to present time (72 hours post-injection).									Y	10/13/2003				UNK	UNK	levothyroxin, hydroxyzine Hcl	None	Adverse reaction to sulfa, erythramycin, & Talwin.  Severe allergic reaction to all corn products. Allergic to broccali, cauliflower, lettuce, peas, mushrooms, melon, apple & pear. Numerous contact allergies.  Hoshimoto's thyroiditis - diagnosed 1982. Interstitial cystitis - diagnosed 1988.			1						1	Headache; Joint range of motion decreased; Musculoskeletal stiffness; Pain; Headache; Joint range of motion decreased; Pain; Skin burning sensation	FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0210124	10/16/2003	NY	37.0			F	10/10/2003	It was reported that a 37-year-old female pt received Fluzone '2003-'2004, lot number and site of administration not reported, administered on 10/6/03 at 9:10am. Within five to ten minutes of receipt, the pt complained of severe pain in the deltoid. Her arm swelled from shoulder to elbow. The pt also had shortness of breath. She was treated in the ER with Benadryl, Solu-Cortef and epinephrine and released. On the evening on 10/7/03, the pt again experienced SOB. She was treated in the ER on the morning of 10/8/03 with Solu-Cortef and epinephrine. The pt was hospitalized at 2pm that day for observation. The recovery status of the pt is unknown.  Follow up on 10/22/2003:  From additional information received on 10/15/2003 from Medical Information Services at AvP, the lot number for the FLUZONE SV '2003-2004 USP product is U1268AA.  The reporter of this case is also the reporter of case 2003-02363. Follow up on 10/28/2003: From additional information received on 10/15/2003 from Medical Information services at AvP, the lot number for the FLUZONE SV '2003-2004 USP product is U1268AA.  The reporter of this case is also the reporter of case 2003-02363. Follow up on 05/19/04 states: No additional information was obtained. No further information is anticipated, this case is considered closed. Follow up 01/26/05: Medical assesment: In the absence of another etiology, the occurence of shortness of breath within five to ten minutes following the vaccination could be compatible with the hypothesis of an allergic like reaction. However, there were no allery tests reported in order to identify a potential sensitization to one of the vaccine components. Additioally, the occurrence of a subsequent episode of shortness of breath may also incite to evoke another etiology, but there were not investigations reported and the patient's recovery status is unknown.				Y	Y				U	10/06/2003	10/06/2003	0		UNK	UNK			Allergy to penicillin		200302308	1						2	Hypoaesthesia; Injection site oedema; Pain; Paraesthesia; Respiratory distress; Dyspnoea; Oedema peripheral; Pain; Dysphagia; Laryngeal oedema; Oedema peripheral; Rash	FLU3~SANOFI PASTEUR~U1268AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U12688A~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Hospitalisation	Influenza
0210451	10/16/2003		47.0			F		A report was received from a health care professional on 10/03/2003 concerning a 47 year old female vaccinee who experienced systemic skin rash, moon face, and eosinophilia requiring hospitalization one day after receiving Fluvirin on 09/24/2003.  The vaccinee has a history of hypertension and long term medication control, but no history of allergies.  Concomitant medications taken included nifedipine, irbesartan, acetylsalicylic acid, atorvastatin, allopurinol, and otenolol and chlorthelidone.  All were started at least one year ago except allopurinol which was started at the end of August 2003.  On 09/25/2003 the vaccinee developed a systemic skin rash which progressively worsened, moon face and eosinophilia.  The vaccinee was hospitalized on an unspecified date.  The vaccinee had not recovered that the time of the report.  There was insufficient information to determine the reporter's causality assessment.  Follow up to be requested: Diagnosis, treatment, date of onset of moon face and eosinophilia ? Outcome? The reporter has assess the relationship of the vaccine to the event as possible. Update 1, 23 February 2004: A follow up report was received from a distributor on 23 February 2004, which indicated that the vaccinee was dischaged from hospital on an unspecified date when her systemic skin rash was under control. The outcome of the moon face and eosinophilia was not reported. The batch number of the vaccine was also provided.					Y				U	09/24/2003	09/25/2003	1		UNK	UNK	Racten, Aprovel, Iapal, Target, Lipitor, Zyloric, Target		Hypertension, long term medication control. No allergies.		PJP200300743	1						1	Cushingoid; Eosinophilia; Rash	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0210453	10/16/2003		29.0	29		M		Shortness of breath, cough, dyspnea on exertion, tachycardia and verified acidosis found by blood test.  Symptoms started two weeks after shot administered, with mild shortness of breath, cough and progressed to respiratory acidosis.  Patient was treated with Prednisone.  Still some residual shortness of breath with exertion.				Y					U	02/04/2003	02/20/2003	16	HCD3 was significantly elevated.  PFT results were (+).  DLCO test was abnormal.  Holter showed chronic sinus tachycardia.	MIL	MIL	NONE	NONE	NONE			1						1	Acidosis; Cough; Dyspnoea; Laboratory test abnormal; Tachycardia	ANTH~EMERGENT BIOSOLUTIONS~fav069~1~SC~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~7+~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0210455	10/16/2003	NJ	23.0	23		F	10/07/2003	Swelling, redness, warmth, joint pain in left arm.									U	10/04/2003	10/05/2003	1	NONE	MIL	MIL	Birth Control	Sore throat	NONE			1						1	Arthralgia; Erythema; Feeling hot; Oedema	ANTH~EMERGENT BIOSOLUTIONS~FAV071~4~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~765412~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210457	10/16/2003	NY	63.0			F	10/07/2003	Patient received injection 10/08/2003 TC to office on 10/09/2003 to state large red, raised area at injection site.  Measures 5m wide by 2 in tall.  Also complained of vomiting sudden onset this AM.  Benadryl 25mg three times a day, and cold pack to area.  Advised to call office if any further problems.									Y				Benadryl (25 mg per mouth three times a day), ice pack to arm	PVT	PVT	Metaglip, Nexium, lasex, Zistril	NONE	NONE			1						1	Rash erythematous; Vomiting	FLU3~EVANS VACCINES~765181~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210458	10/16/2003	NY		49		F	10/01/2003	Patient developed erythema and swelling at site approximately 8mm across and 5 mm vertical.  Reported mild itching within 24 hours of injection.									Y	10/01/2003			Ice pack to area prn	PVT	PVT	NONE	Being treated for allergies	Multiple allergies receives weekly allergy shots			1						1	Injection site erythema; Injection site oedema; Pruritus	FLU3~EVANS VACCINES~765181~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210459	10/16/2003	NY	67.0	67		F	10/08/2003	Patient called office 10 AM 10/08/2003 to state site where she received flu shot was very red and swollen states not painful but did concern her.  Area is raised, slightly red, approximately 2.5 inches wide by 1.5 inches tall.									Y	10/07/2003	10/07/2003	0	Benadryl 25mg, three times per day as needed.  Ice pack to skin reaction	PVT	PVT	Lopressor, HCT2, Levothyroxine, Zestril	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site swelling	FLU3~EVANS VACCINES~765181~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210460	10/16/2003	TX	4.0	4		M	10/15/2003	On 10/06, patient developed rash on legs/feet, annular rash (with urticarial component described by mom, improved by time seen in office).  Seen 10/09 with couple dozen annular macular, erythematous lesions.  Some coalesing up to 3 cm each, no target lesions, or urticaria on 10/09.  Lesions were only on lower extremities, and beginning to fade on 10/09.									U	10/01/2003	10/06/2003	5	NONE	PVT	PVT	FLOVENT	History of asthma	Asthma			1						1	Erythema; Rash macular; Skin ulcer; Urticaria	FLU3~SANOFI PASTEUR~U1267AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210461	10/16/2003	AZ	55.0	55		F	10/15/2003	Hot, red, localized 4 cm x 2 cm area at injection site with chills, headaches, stiff muscles, stiff neck within 1 hour.									Y	10/14/2003	10/14/2003	0	NONE	PVT	PVT	Lipitor	NONE	NONE			1						1	Feeling cold; Headache; Injection site erythema; Injection site warmth; Musculoskeletal stiffness	FLU3~EVANS VACCINES~765665~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210462	10/16/2003	MA	74.0	74		F	10/15/2003	Syncope at home-transported to ER via ambulance-Temperature 95 degrees, pulse 50				Y					Y	10/10/2003	10/10/2003	0	NONE	PVT	PUB	Atenolol ASA, Zantac	NONE	Seasonal, GERD, GAD			1						1	Pyrexia; Syncope	FLU3~SANOFI PASTEUR~U1048AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210463	10/16/2003	TN	18.0	18		M	10/06/2003	Patient fainted, felt dizzy, and saw spots.  He was given orange juice and sat down for 5-10 minutes.  He states that he felt better and his color returned. 18:25: patients mother called and stated he has always been afraid of shots and gets lightheaded whenever he gets a shot.									Y	10/06/2003	10/06/2003	0	NONE	OTH	PVT	Minocycline for dermatol	NONE	NONE			1						1	Dizziness; Hallucination, visual; Syncope	FLU3~SANOFI PASTEUR~U1079AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210464	10/16/2003	VA	0.6	0	.5	M	10/10/2003	1 hour after vaccine, patient developed swelling and redness at injection site of Fluzone.  Hives, wheezing.  Patient returned to office treated with epinphrine, Benadryl, Albuterol reb, symptoms resolved within 15 minutes after epinphrine.  Patient observed for 2 hours with no further symptoms.									Y	10/09/2003	10/09/2003	0	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Urticaria; Wheezing	DTAP~SANOFI PASTEUR~C1527AA~3~~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1098AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE031AA~3~~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~493262~3~~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0210465	10/16/2003	NY	2.0	2	.2	F	10/08/2003	Onset facial swelling and diffuse macular, non-urticarial rash within 24 hours of vaccination.				Y					Y	10/06/2003	10/07/2003	1	NONE	PVT	PVT	NONE	NONE	Poor weight gain, delayed speech development			1						1	Face oedema; Rash macular; Urticaria	FLU3~SANOFI PASTEUR~U1145AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210466	10/16/2003	NJ	61.0	61		F	10/06/2003	Injection site (deltoid) erythema, edema and pain. A follow up report received 10/20/2003 adds: Right deltoid (injection site) (caused by Pneumo shot). Rx ice, Benadryl, elevation, Motrin.				Y					Y	10/02/2003	10/02/2003	0		PVT	OTH	Lopressor, Imdur, Protonix	NONE	HTN, CAD, GERD			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U1253AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1026M~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210467	10/16/2003	WA	44.0	44		F	10/06/2003	Developed rash on forearms, forehead, trunk, legs. Self resolving, no Benadryl taken.									Y	10/06/2003	10/06/2003	0	NONE	PVT	PVT	Premarin, Vioxx, Provera, vitamins	NONE	NONE	flu-like~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Rash	FLU3~EVANS VACCINES~765670~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210468	10/16/2003	NE	86.0	86		F	10/06/2003	5 minutes after flu shot pt experienced nausea, lightheadedness, diaphoresis, BP 89/50, slurred speech, confused.				Y					U	10/06/2003	10/06/2003	0		OTH	OTH						1						1	Confusional state; Dizziness; Dysarthria; Hyperhidrosis; Nausea	FLU3~EVANS VACCINES~765667~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0210469	10/16/2003	AL	64.0	64		F	10/10/2003	Developed some swelling, erythema and pruritus at and around the site of her left arm. These symptoms began the next day after the injection. She did not have fever or chills. Treatment: Tylenol 500mg PO every 4 hours PM if the symptoms worsen notify MD.				Y					Y	10/02/2003	10/03/2003	1	NONE	PVT	PVT	Atenolol, Maxide, Lipitor, aspirin, multi vitamins, calcium, Activella, Univase, Paxil	NONE	Arterial hypertension			1						1	Injection site erythema; Injection site oedema; Pruritus	FLU3~EVANS VACCINES~765412~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0210470	10/16/2003	KS	39.0	39		F	10/09/2003	Localized fever, redness measuring 3 in diameter, area is hardened, tenderness. Instructed to use Benadryl and ibuprofen or Tylenol.									U	10/07/2003	10/08/2003	1		PVT	OTH	Toprol XL, Norvasc	NONE	Sulfa, Rocephin; HTN			1						1	Injection site erythema; Injection site induration; Pain; Pyrexia	FLU3~EVANS VACCINES~765501~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210471	10/16/2003	TX	66.0			F	09/29/2003	Caught influenza. Sick 4 days. Was I injected with live virus or no time to develop immunity? While sick I saw MD.				Y					Y	09/18/2003	09/26/2003	8		UNK	UNK						1						1	Influenza	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0210533	10/16/2003	CA	56.0	56		F	10/16/2003	Severe burning, aching, debilatating pain in and around site of injection, starting approximately 30 minutes following vaccination and continuing for about 7 hours. No relief with 350mg acetaminophen-codeine. Symptoms improved during following day, then reoccured upon arising at approximately 54 hours post-injection and continued to present.  Pain in shoulder includes both severe pain without movement, as well as inability to raise or move arm without extreme pain and stiffness.  No edema, rash, or inflamation is present.  However, mild to moderate body and headache occured during first 48 hours post-injection.									U	10/13/2003	10/13/2003	0	None	PUB	PVT	levothyroxin, hydroxyzine Hcl	None	Severe corn allergy. Moderate allergy to broccoli, cauliflower, lettuce, cabbage, peas, apple, pear, melon, peanuts, and grapes.  Severe allegic reaction to sulfacetamide, erythromycin, Talwin (pentazocine), and Macrodantin (nitrofurantoin).			1						2	Headache; Joint range of motion decreased; Musculoskeletal stiffness; Pain; Headache; Joint range of motion decreased; Pain; Skin burning sensation	FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0210535	10/16/2003	NY	41.0	41		F	10/16/2003	broke out in hives 2-3 days after receiving vaccine.									Y	10/09/2003	10/11/2003	2		UNK	UNK		none	allergic to penicillin			1						1	Urticaria	FLU3~EVANS VACCINES~1306A~1~ID~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210568	10/16/2003	NC	56.0	56		F	10/14/2003	As the needle was being withdrawn after injection, blood started to come out of the arm and I noticed a little swelling and bruising to the area surrounding the site about 1 in. in diameter. procedure for injection was followed and done correctly. I as the patient how she felt, and if she was currently on coumadin or aspirin products, she felt fine and she was not doing any of those meds.  We gave benadryl for the swelling and watched her for a while until we were sure the swelling had stopped. We informed her of what side effects to look for after having the influenza vaccine and told her what to do if the swelling started back.  We also told her that we would call later in the afternoon to see how she was doing.  I spoke to a medical Dr. at the maker of the vaccine, just to see if a rxn such as this is reported frequently or not.  Dr agreed that we did the right things for the patient and advised as I did to tell the patient to see her local dr. and get get her blood count check to assess whether there are any bleeding disorders, etc.  I called the patient back in the afternoon and she was still fine and I informed her of my conversation with dr. at manufacturer and she agreed that she would go visit her Dr. for the blood count assessment. get a									Y	10/14/2003	10/14/2003	0	n/a	UNK	UNK	NONE	NO- SEE ATTACHED SCREENING TOOL MAILED  WITH THIS FORM	N/A			1						2	Contusion; Injection site oedema; Contusion; Injection site oedema; Contusion; Injection site oedema	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U12708A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA		Influenza
0210592	10/16/2003	IL	40.0	40		F	10/16/2003	erythmia,warm to touch, increases swelling, soreness, mild fever.				Y					Y	10/15/2003	10/15/2003	0		MIL	MIL	Prozac, Zyrtec		allergies- cats, molds, dust  mites			1						1	Erythema; Feeling hot; Oedema; Pyrexia	FLU3~SANOFI PASTEUR~u1147aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210594	10/16/2003	GA	46.0	46		F	10/16/2003	Swollen lymph node on left clavicle.  Patient given Keflex 500mg qd for 5 days.  Swelling decreased.									Y	10/08/2003	10/10/2003	2		MIL	MIL	None	none	None			1						1	Lymphadenopathy	FLU3~EVANS VACCINES~765416~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210595	10/16/2003	UT	33.0	33		M	10/16/2003	Vaccine given in early afternoon. Pt. went home and laid down.  Reported rigors and extreme muscle tremors all night.  Currently complaining of joint aches and locked knees.  Fiancee administered tylenol and benedryl.									U	10/15/2003	10/16/2003	1	None done at time of report.	UNK	UNK	None	None	None			1						1	Arthralgia; Chills; Tremor	FLU3~SANOFI PASTEUR~u1122aa~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210596	10/16/2003	NY	3.0	47		M	10/16/2003	Extreme dizziness upon waking at 5:45 a.m. the day after injection.  Dizziness reduced and gone by 2:00 p.m.									Y	10/15/2003	10/16/2003	1		UNK	UNK						1						1	Dizziness	FLU3~EVANS VACCINES~765416~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210597	10/16/2003	MS	69.0	69		F	10/08/2003	Slight redness noted on right deltoid with swelling.  area felt warm to the touch.  oral temp 99.2 on 10/8, BP 110/60 patient going to pmd for check up				Y					Y	10/07/2003	10/07/2003	0	none	PUB	PUB	noves,topeal, clariden, benecar, trycore	none	hypertention		MS03081	1						1	Erythema; Feeling hot; Oedema; Pyrexia	FLU3~SANOFI PASTEUR~U1094AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1026M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210599	10/16/2003	CA	55.0	55		M	10/16/2003	Approx. 2 days following vaccination, pt. experienced minor systemic fatigue and muscle ache. At day 3, pt. developed a cough with continued fatigue. At day 4, pt. developed a worsening cough with yellowish, thick sputum, 100.7 fever and urinary hesitancy. On days 4-6, productive cough persisted with fever ranging 100.7-101.4. By day 7, pt. reported improving condition and temperature within normal limits.									U	10/09/2003	10/11/2003	2	none taken	PUB	PUB	none	none	NKDA; medical history is unremarkable			1						1	Cough; Fatigue; Myalgia; Pyrexia; Urinary hesitation	FLU3~EVANS VACCINES~765145~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210600	10/16/2003	GA	65.0	65		F	10/16/2003	Daugher of patient called stating patient had a reaction to the pneumonia vaccine.  Patient in to the clinic.  Right arm with swelling at sight, heat, pain on abduction and to the touch.  Patient putting alcohol on site.  Swelling, heat, pain, and reddness with induration noted.  Patient instructed to take motrin and apply ice to site.									Y	10/15/2003	10/15/2003	0		PUB	UNK		none	nkda			1						1	Feeling hot; Injection site erythema; Injection site oedema; Pain	FLU3~EVANS VACCINES~765707~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0564N~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210563	10/17/2003	VA	2.0	2	.5	M	10/14/2003	He devloped febrile seizure following day after he received influenzae shot. Child was taken to ER, blood work and physical exam were normal. Child was sent home. Medical records state atelectacis, cold, rhinnitis. msv			Y	Y					Y	10/07/2003	10/08/2003	1		PVT	UNK		Cold	Anemia			1						1	Atelectasis; Febrile convulsion; Pharyngitis; Rhinitis	FLU3~SANOFI PASTEUR~U1139AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0210566	10/17/2003	AZ	4.0	4		F	10/16/2003	Per school personnel, pt has red rash over face									Y	10/14/2003	10/15/2003	1		PVT	PUB	NONE	NONE	NONE			1						1	Rash	FLU3~SANOFI PASTEUR~U1091AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0138M~5~IM~RA~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0134N~1~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0210567	10/17/2003	FL	58.0	58		M	10/14/2003	Feels cruppy, wobbly and weak and thinks he may have a fever, but has no thermometer. Lasted approx 12-14 hours.									Y	10/13/2003	10/13/2003	0		PVT	PVT	Avandia, Pannion, Captopril, Lipitor, Tricor, Hestinon, Mestinon, Levsin, Attelin, Metronin, HCTZ, Trileptal, B12 and multivitamins		Diabetes mellitus, HTN, multiple sclerosis, myasthenia gravis, triglinal neuralgia			1						1	Balance disorder; Malaise; Pyrexia	FLU3~SANOFI PASTEUR~U1141AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210568	10/17/2003	NC	56.0	56		F		As the needle injected was being removed from arm, pt began to bleed and bruise around area of injection about 1 in diameter, and slight swelling occurred. Pt felt fine, we gave Benadryl oral and (unreadable). Advised her on what to do if swelling started again. And we called later that evening to see what the status of her condition was and she was fine.									Y	10/14/2003	10/14/2003	0		UNK	UNK		NONE	No allergies			1						1	Contusion; Injection site oedema; Contusion; Injection site oedema; Contusion; Injection site oedema	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U12708A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA		Influenza
0210569	10/17/2003	DE	51.0	51		F	10/13/2003	Large area of redness, denies SOB									Y	10/09/2003	10/10/2003	1		PVT	PVT	Allegra	NONE	NKA			1						1	Erythema	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210570	10/17/2003	DE	47.0	47		F	10/13/2003	Large area redness, denies SOB.									Y	10/10/2003	10/11/2003	1		PVT	PVT	NONE	NONE				1						1	Erythema	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210579	10/17/2003	WV	2.2	2	.2	M	10/13/2003	Patient received Pneumovax 23 on 10/09/2003 in right thigh.  By the next day, entire lower leg/knee on that side swollen to size of large orange; also red/warm.  No obvious infection.  Initially patient limping; seen today and now ambulatory normally end swelling about gone.				Y					Y	10/09/2003	10/10/2003	1	NONE	PVT	PVT	Xopenex, Pulmocort, Regenlies, Singulair, Zyrtec	Asthma	Asthma			1						1	Feeling hot; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1102AA~5~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0740N~1~IM~RL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210649	10/17/2003	MO	40.0	40		F	10/17/2003	PATIENT DEVELOPED FEVER TO 102F, MYALGIAS, CHILLS AND ARM SWELLING AND SORENESS, BEGINNING DAY OF VACCINE (GIVEN SUBCUTANEOUSLY IN RIGHT ARM).  PATIENT IS DIABETIC, AND HAD SIGNIFICANT HYPERGLYCEMIA WITH ILLNESS.  PATIENT WAS SEEN 2 DAYS AFTER VACCINE, AND HAD LARGE, RED, ERYTHEMATOUS INJECTION SITE, FEVER, AND LEUKOCYTOSIS.  CLINICAL IMPRESSION IS CELLULITIS.				Y					U	10/14/2003	10/14/2003	0	WBC 27.3K	PVT	PUB	LIPITOR, PREMARIN, BELLAMINE, HCTZ, SPIRONOLACTONE, HUMALOG INSULIN, ASA	NONE	DIABETES, HYPERLIPIDEMIA, ENDOMETRIOSIS, SYMPTOMATIC EDEMA, HISTORY OF MANDIBULAR MALIGNANCY IN CHILDHOOD;ALLERGIES: DIFLUCAN, FLUORESCEINE DYE			1						1	Cellulitis; Chills; Injection site erythema; Injection site pain; Leukocytosis; Myalgia; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U1136AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~O531N~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210650	10/17/2003	CA	21.0	21		M	10/17/2003	Patient's symptoms include swollen throat				Y					Y	10/16/2003	10/16/2003	0		UNK	PVT	none	none	none			1						1	Pharyngeal oedema	FLU3~SANOFI PASTEUR~U1093AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210652	10/17/2003	CA	62.0	62		F	10/17/2003	Arm was red, hot and swollen within an hour after injection.Called MD and was told to watch. Swelling and heat spread down to elbow & caused old smallpox scar on arm to become outlined. Applied ice & took a non-aspirin tab. Arm continues to be red and sore after 8 days, but swelling is gone.									N	10/09/2003	10/09/2003	0		PVT	UNK	Trimetherene Atenol	none.	High blood pressure.	Fever, site inflammation~Smallpox (Dryvax)~~3.00~In Patient		1						1	Erythema; Feeling hot; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0210653	10/17/2003	CA	77.0	76		F	10/17/2003	pt experienced 10/10 lower back pain across her upper buttocks, bilaterally and extending across the spine, 30 seconds after administration of flu and pneumovax.  Never had similar pain before.  Lasted about 5 minutes.  Normal vitals during attack, including O2 sat, exept rapid shallow respirations due to the pain.  After that, noted mid upper chest pressure for about 3 minutes, without SOB, diaphoresis or radiation.  Symptoms occurred while seated; made her squirm and moan and very distressed, due to the intensity of the pain.  Significant PMHx:  yearly flu shots without reaction, osteoporosis on Fosamax.				Y					Y	10/16/2003	10/16/2003	0	see #7	PVT	PVT	fosamax,atenolol, lipitor, dyazide, probably aspirin	none	hyperlipidemia, rheumatoid arthritis, hypertention, osteoporosis, CVA, colon polyp, s/p ORIF right hip, mild memory loss			1						1	Back pain; Chest discomfort; Hypoventilation	FLU3~EVANS VACCINES~765142~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0676M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210656	10/17/2003	NJ	43.0	42		F	10/17/2003	Pt returned to Mobile Health Unit 10 mins after vaccine administered with SOB, and heaviness in chest area. VS BP 120/80, P-140, R-26. EMS activated. Pt transported to SIUH-N ED. Follow up call made and pt verbalized that ED administered Benadryl. Spoke to pt at home and she stated she no longer has any acute distress				Y					Y	10/17/2003	10/17/2003	0		UNK	PVT	None	None	None			1						1	Chest pain; Dyspnoea; Heart rate increased	FLU3~EVANS VACCINES~765142~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0210657	10/17/2003	IA	9.0	9		M	10/17/2003	Right deltoid area red, swollen, and warm to touch.				Y					Y	10/15/2003	10/17/2003	2		PVT	PVT	Lexapro, Strattera, OTC cough meds					1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1095AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210661	10/18/2003	WA	60.0	60		F	10/18/2003	Extreme swelling around eyes. Three days before returning to normal. I have eaten eggs on numerous occasions since with no adverse effects.									Y	11/12/2002	11/13/2002	1		UNK	PVT	Levoxyl	No	Codeine-Tylenol, IVP dye, Aspirin, Sulfacetamide			1						1	Eye swelling	FLUX~UNKNOWN MANUFACTURER~~6~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0210662	10/18/2003	NC	64.0	64		F	10/18/2003	Inactivated Influenza Vaccine received October 17, 2003 between 12 and 1:00 PM.  Approximately 1 hour later patient was sitting in chair on our driveway talking to a friend when he experienced a moderately strong dizzy spell which lasted about 15 minutes and then subsided.  No other adverse symptoms noted.  Patient did not feel it necessary to contact either the clinic or the doctor.									Y	10/17/2003	10/17/2003	0	Vaccine received on October 17, 2003 - first and only time he has experienced any reaction to vaccine shots	PUB	UNK	Atenolol 100mg;:Lisinopril 20 mg;Multi vitamin;Aspirin 81mg taken daily and Prilosec 20 mg as needed and he had taken one at lunch approximately 45 minutes before vaccine administered	None	allergy to penicilline and existing high blood presure problems.  Has had heart by-pass surgery approximately 6 years ago			1						1	Dizziness	FLU3~EVANS VACCINES~765178~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210663	10/18/2003	OH	43.0	43		F	10/18/2003	Fatigue,myalgias. Area of erythema and tenderness at injection site and pruritis. Treated with NSAIDs and antihistamines.									Y	10/15/2003	10/16/2003	1		PVT	PVT	Paxil, Cestin, Synthroid	None.				1						1	Fatigue; Injection site erythema; Injection site pain; Myalgia; Pruritus	FLU3~SANOFI PASTEUR~U1089AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210664	10/18/2003	MN	40.0	40		F	10/18/2003	Immediately after receiving the flu vaccine, became sick with the flu. Serious fatigue, fever, headache, elevated temperature. A follow up report received 10/22/2003 adds: Plus ringing in ears.									U	10/15/2003	10/15/2003	0		UNK	UNK		None	None			1						1	Fatigue; Headache; Influenza like illness; Pyrexia; Tinnitus	FLU3~SANOFI PASTEUR~U1267AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210666	10/18/2003	FL	33.0	33		F	10/18/2003	2 days after recieving vaccine I began to experience a mild cough, a twitchy feeling that didn't go away.  After appr. 12 days, I started to experience shortness of breath, severe fatigue, feeling like I had a moderate case of the flu, along with mild headache, dry cough, chest pain, sore eyes, muscle weakness,  and loss of appetite. A prescription for Z-Pack was called in, and I am on this medication at the present time.									U	10/03/2003	10/05/2003	2		PVT	UNK	Multi Vitamin		Dx. of Asthma at 17 years of age.			1						1	Anorexia; Chest pain; Cough; Dyspnoea; Eye pain; Fatigue; Headache; Influenza like illness; Muscle twitching; Muscular weakness	FLU3~SANOFI PASTEUR~U1068AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210667	10/19/2003	WA	38.0	38		F	10/19/2003	After eight hours from the time of the flu shot, I experienced a rapid heat beat and increased resperation.  Normal sitting pulse for me is 70 to 80 per minute, I was experiencing a pulse rate from 135 to 145 per minute.  Normal sittting resperation is 12 per minute, resperation increased to 21 per minute.  I have a persciption for Trazadone, I took a 20 mg tablet, at that point pulse was reduced to 90 beats per minute and resperation was reduced to 14 per minute, after 20 minutes after taking trazadone.  I fell a sleep after that.  12 hours later I woke up, feeling okay, skin was iching the night before as well.									Y	10/16/2003	10/17/2003	1		PUB	PVT	celexa 20mg 3x per week flexeral 20 mg 2 x per week trazadone 20 mg 1/2 per week	none	none			1						1	Heart rate increased; Pruritus; Respiratory rate increased	FLUX~UNKNOWN MANUFACTURER~97007~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0210604	10/20/2003		70.0			M		A report was received from a distributor on 10/06/2003 concerning a 70 year old male vaccinee who felt uncomfortable on the same day as receiving Fluvirin vaccine on 09/25/2003 and developed Stevens-Johnson syndrome with mouth ulceration requiring hospitalization an unspecified length of time after receiving Fluvirin vaccine.  On the evening of 09/25/2003 the vaccinee felt uncomfortable.  An unspecified length of time after vaccination the vaccinee experienced mouth ulcerationand Stevens-Johnson syndrome was diagnosed.  The vaccine was admitted to an intensive care unit on an unspecified date in order to prevent infection.  The outcome of the events was not reported. There was insufficient information to determine the reporter's causality assessment.  Follow up pending. Update 1, 23 February 2004: A follow up report was received from a distributor which indicated that the vaccinee had ulceration of the urological system making it difficult for him to control his urine. The vaccinee had cataracts before he received Flurivin and his vision is now worse thatn before vaccination. The operation to rectify the cataracts cannot go ahead of the ulcerations.					Y				U	09/25/2003				UNK	UNK					PJP200300757	1						1	Aphthous stomatitis; Stevens-Johnson syndrome; Urinary incontinence; Urinary tract disorder; Visual acuity reduced	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0210605	10/20/2003					F		A report was received from a health care professional on 10/6/03 concerning a female vaccinee of unspecified age who experienced a red, sore arm with swelling and frozen shoulder with muscle wastage, was considered medically significant an unspecified length of time after receiving Fluvirin on an unspecifieed date in October 2002. On an unspecified date the vaccinee experienced a red, sore arm with swelling which lasted 4 to 6 weeks. The vaccinee had an orthopaedic referral which diagnosed a frozen shoulder with muscle wastage. The outcome of the event was not reported. There was insufficient info to determine the reporter's causality assessment. Follow up pending.								Y	U	10/14/2002	02/11/2003	120		UNK	UNK	Gliglazide, Zalbutamol, Gaviscom Liquid, Mizatidine, Adalai, Metformin, Guinine Sulfmate, Peppermint Oil, Frosemde		Hypertension, Diabetes Mellitus, Diverticular Disease		PJP200300756	1						1	Erythema; Oedema; Pain	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0210606	10/20/2003	GA	49.0	49		F	10/15/2003	Small red area on right arm with increased warmth 2 days after injection. Pt given 5 day treatment of antibiotics in case it was infection.									Y	10/13/2003	10/15/2003	2	V04.8	PVT	OTH	Lipitor, Premptaze	Thoracic strain	NKDA; hyperlipedmia, migraine headaches			1						1	Feeling hot; Injection site erythema	FLU3~EVANS VACCINES~765180~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210607	10/20/2003	VA	48.0	48		M	10/17/2003	Received flu vaccine on Wed. 10/15/03. On Thurs. 10/16/03 he noted welts on both arms from shoulders to wrist, area and a few on his neck. Today noted red bumps on his left side.									U	10/15/2003	10/16/2003	1		OTH	PVT	Allegra	NONE				1						1	Rash erythematous; Urticaria	FLU3~SANOFI PASTEUR~U1077AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210608	10/20/2003	PA	0.5	0	.5	M	10/10/2003	Right thigh became dark red and hard 28 hours after vaccine administered. Began resolving within 12 hours.									Y	10/08/2003	10/09/2003	1		PVT	PVT	Zithromax	Bilateral otitis media				1						1	Injection site erythema; Injection site induration	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~21882B2~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1097AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~493262~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0210611	10/20/2003	CA	4.0	4		M	10/12/2003	Right deltoid - well demarcated area of erythema, not raised, blanchable, no increased warmth, nontender, no oozing, no bleeding. Pt afebrile. Pt nontoxic in office and alert/playful/cooperative. No tx given.									Y	10/10/2003	10/11/2003	1	NONE	PVT	UNK		NONE	NONE			1						1	Injection site discolouration; Injection site erythema	DTAP~GLAXOSMITHKLINE BIOLOGICALS~610A2~UNK~~LA~DTAP (INFANRIX)~1|FLU3~EVANS VACCINES~765667~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~W0334~UNK~~LA~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~1180M~UNK~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0210612	10/20/2003	TX	50.0	50		M	10/16/2003	Redness of face, arms, bilateral hand swelling, tingling. Lips tingling.									Y	10/16/2003	10/16/2003	0		PVT	UNK						1						1	Erythema; Oedema peripheral; Paraesthesia	FLU3~EVANS VACCINES~765308~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210613	10/20/2003	IL	48.0	48		M	10/16/2003	Received flu vaccine on 10/14/03. Complained of chills/fever/lethargy approx 4-6 hours after receiving vaccine. Symptoms lasted 24-36 hours.									Y	10/14/2003	10/14/2003	0		OTH	OTH	Tiazac	NONE	Allergic to aspirin and cortisone, Dx heart disease			1						1	Chills; Lethargy; Pyrexia	FLU3~SANOFI PASTEUR~U1094AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210617	10/20/2003	FL	71.0	71		F	10/17/2003	Pt received pneumonia vaccine at supermarket at about 12 PM. 4 hours later, swelling, pain at site of vaccine Left deltoid muscle. Treatment: ice, rest, antiinflammatory, etc.				Y					Y	10/17/2003	10/17/2003	0		OTH	OTH	Lipitor, Premarin, Atenolol, Aleve	NONE	NONE			1						1	Injection site oedema; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0210628	10/20/2003	AZ	69.0	69		F	10/06/2003	30 minutes after injection started shaking and had chills.  Had hourglass hives on face.  Next morning tongue was swollen and developed hives all over body.  Throat and mouth was beet red saw family MD on 10/09/2003, was given Prednisone 20 mg one time a day for 1 week and Benadryl 25mg, `1 tab every 4 hours.  Had chills again today 10/13/2003 right knee is swollen since 2 days after injection.  History of right knee surgery, history of breast cancer.									Y	10/06/2003	10/09/2003	3	NONE	OTH	PVT	Vioxx, AST, Blood pressure medication, Tomoxifen	NONE	PCN, Breast Cancer, Right knee surgery			1						1	Chills; Erythema; Tongue oedema; Tremor; Urticaria	FLU3~EVANS VACCINES~765709~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0564N~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210629	10/20/2003	OR	76.0	76		F	10/09/2003	Vaccine (influenza) administered at 13:00 on 10/08/2003-patient developed high fever (105 F) with rigors beginning around 16:00.				Y					Y	10/08/2003	10/08/2003	0	NONE	OTH	OTH	UNK	UNK	UNK			1						1	Chills; Pyrexia	FLU3~SANOFI PASTEUR~U1142AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210630	10/20/2003	MI	56.0	56		F	10/08/2003	Tongue swelling, difficulty breathing, rash on inner thighs bilateral.				Y					Y	10/06/2003	10/07/2003	1	NONE	PVT	OTH	NONE	NONE	ALLERGIC TO COMPAZINE, HISTORY OF BREAST CANCER - 1985			1						1	Dyspnoea; Rash; Tongue oedema	FLU3~SANOFI PASTEUR~U1080AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210635	10/20/2003	NJ	34.0	34		F	10/09/2003	Swelling right arm for 5 days.									U	10/04/2003	10/04/2003	0	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Injection site oedema	FLU3~SANOFI PASTEUR~765412~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~CONNAUGHT LABORATORIES~W13662~1~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0210637	10/20/2003	IL	68.0	68		M	10/13/2003	Red, warm area 3-4 inches in diameter.  Treatment Diphenhydramine 50 mg every 6 hours; Ibuprofen 400 mg every 4-6 hours; around pneumonia vaccination site.									Y	10/09/2003	10/10/2003	1	NONE	OTH	PUB	NONE	NONE	NONE			1						1	Feeling hot; Injection site erythema	FLU3~EVANS VACCINES~765138~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0709M~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210643	10/20/2003	RI	9.0	9		M	10/09/2003	Blotchy rash, itchy over all body, mostly on neck and face.  No respiratory problems.  Adviced to use Benadryl, however parents used some home remedies and the rash and swelling went away.  His eyes remained injected and his skin in the neck area was itchy the next day in the office. A follow up report received 10/22/2003 adds: Conjunctivitis treated with Benadryl/Tetanol eye drops.				Y					Y	10/08/2003	10/08/2003	0	NONE	PUB	PUB	NONE	Occasional right heel pain	NONE			1						1	Conjunctivitis; Rash macular; Rash pruritic	FLU3~SANOFI PASTEUR~126DAA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210696	10/20/2003	NY	50.0	50		M	10/20/2003	I received the shot about 4:45 pm on Thursday, October 16.  I was not feeling well that afternoon and evening: sneezing and some coughing.  I woke about 1 am the morning of Friday, October 17 with a high fever and a great deal of coughing. I was listless.  The site of the injection was painful (right arm, medial, shoulder)  I did not take my temperature until about 3 am and at that time it was 100.6 and climbing.  The fever increased to 101.2 by about 4:14 am at which time I took 1 table of 800 mg of Ibuprofen and 4, 500 mg capsules of amoxicillin that I am prescribed to take as a pre-medication for dentist visits.    I fell asleep and woke about 4 hour later and the fever was down, but the other symptoms persisted.    I continued to take 1 tablet / 1 capsule of the ibuprofen and amoxicillin at 4 hour intervals over Friday, Saturday, Sunday and into today (Monday).  The fever is under control and I am slowly improving.  Additional information for part 13, line 1.  The vaccine manufacturer is Evans									Y	10/16/2003	10/17/2003	1		PUB	PVT	none	none	heart murmur, mild			1						1	Cough; Injection site pain; Pyrexia; Sneezing	FLUX~UNKNOWN MANUFACTURER~765500~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0210697	10/20/2003	OH	43.0	43		F	10/20/2003	Severe pain in legs and hip joints, light headed feeling.									U	10/14/2003	10/16/2003	2		PUB	PUB	Prozac, Premerin	None known	allergic to Pencillin, sulfa, and Zomax			1						1	Arthralgia; Dizziness; Pain	FLU3~SANOFI PASTEUR~U1270AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210699	10/20/2003	NJ	49.0	49		M	10/20/2003	Patient dropped in this a.m. stating that he awoke the morning of 18 October 2003 with malaise, general achiness, and crankiness ( per a close friend). This has continued until this a.m. No fever. Has slight pain at injection site, but no swelling or heat over area.									U	10/17/2003	10/18/2003	1		UNK	PVT		no	frequent sinusitis			1						1	Injection site pain; Irritability; Malaise; Pain	FLU3~SANOFI PASTEUR~U1087AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210700	10/20/2003	CA	42.0	42		F	10/20/2003	PATIENT STATES THAT SHE HAD REDNESS,SWELLING,WARM TO TOUCH AND SORENESS BELOW SITE OF INJECTION ON 10/16/03. SHE STATES THAT SIGNS AND SYMPTOMS HAD INPROVED BY 10/17/03 AND THAT SHE HAD TAKEN IBUPROFEN FOR TREATMENT. LOCAL REACTION ONLY.									U	10/15/2003	10/16/2003	1		PVT	PVT	TAPAZOLE	NONE	GRAVES DISEASE			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1078AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210709	10/20/2003	MI	55.0	55		U	10/20/2003	HUSBAND AND I BOTH RECEIVED FLU AND PNEUMONIA SHOTS, AND THAT EVENING WE BOTH STARTED TO GET ILL.  CHILLS, FEVER, DRY HEAVES, RASH, REDNESS, I ALSO HAD BILLIONS OF PUSS FILLED BLISTERS AT THE INJECTION SITE.  THIS STARTED AFTER THE SHOTS ON 10-9.  WE WERE BOTH SEEM AT THE CLINIC ON SATURDAY, THE 11TH.  THEN I HAD TO BE SEEN AT THE EMERGENCY ROOM ON NEXT TUESDAY NIGHT, 10-14.  WE WERE TOLD WE HAD CELLULITIS, AND NEEDED TO BOTH GO ON ANTI-BIOTICS.  WE ARE STILL TAKING THEM.  WE WERE GIVING OUR SHOTS BOTH IN THE SAME ARM.  WE UNDERSTAND WE WERE NOT SUPPOST TO GET THEM IN THE SAME ARM.  MY ARM STILL HAS BLACK SCABS AT THE INJECTION SITE. MY HUSBAND ALSO NEEDED A BREATHING TREATMENT WHILE WE WERE IN THE CLINIC.				Y					Y	10/09/2003	10/10/2003	1		PVT	PVT		NONE	Diabetic, high lipids, hypertension, retanopathy			1						1	Cellulitis; Chills; Erythema; Injection site vesicles; Pyrexia; Rash; Retching	FLU3~EVANS VACCINES~765179~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~6564N~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210670	10/21/2003	NC	81.0	80		F		An 81 year old female received RSV vaccine or placebo and Influenza vaccine on 10/30/02 and 107 days later came into the office with weakness, shortness of breath, malaise. She presented with BP 92/50 and weight loss of 20 lbs over the last month. She had not been eating very well. She was sent by ambulance to the hospital and admitted on 2/14/03. Signs/Symptoms/Diagnosis included esophageal dysfunction 9scheduled to have barium swallow in hospital), CHF, depression. The patient was treated with IV fluids and Prevacid. There was one episode of CHF due to over vigorous hydration which resolved. She refused to eat. Evaluated by psychiatry, transferred to psychiatry 2/20/03. The patient was prescribed Remeron from 2/20/03 until death. Patient was not responding in treatment program for depression. Found unresponsive in bed 3/1/03. CPR initiated there was no response and she was pronounced dead. Diagnosis was : Depression, Anxiety, Atrial Fib, Mitral Regurgitation. Cause of death was given as probable myocardial infarction. No autopsy will be performed. The investigator assessed the events as unrelated to the study products. Further information is expected. Additional information received on 10/7/03: Copy of death certificate: signed 3/1/03; date of death:3/1/03. Cause of death: lethal arrythmia - approximate interval between onset and death - 30 minutes. Secondary cause: atrial fib - approximate interval between onset and death - 5 years. Other significant conditions contributing to death but not resulting in the underlying cause given in Part 1 - Mitral valve regurgitation. No autopsy performed. A 15-day follow up report received 10/23/2003 adds: 10/17/2003: No new info is anticipated. Case is closed. Death Certificate received on 10/27/2003 states COD was arrthymia and atrial fibrillation.	Y	03/01/2003			Y				N	10/30/2002	03/01/2003	122	All lab tests normal; Barium swallow all normal. Abdominal ultrasound 16/2/03.	UNK	UNK	RSV/Placebo, Coumadin, Diltiazem, Lasix, Lanoxin, Altace, Prevacid		CHF; History of diverticulitis; Temporal arteritis; Polymyalgia rheumatic		200300247	1						1	Arrhythmia; Asthenia; Atrial fibrillation; Blood pressure decreased; Cardiac failure congestive; Coma; Depression; Dyspnoea; Malaise; Myocardial infarction; Weight decreased	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0210671	10/21/2003	NC	81.0	81		F		An 81 year old female received RSV vaccine or Placebo and influenza vaccine in the RSV 11 study on 10/15/02; and on 7/16/03 died at home of congestive heart failure, 274 days after vaccination. The subject had been placed on hospice for severe CHF not responding to treatment. The pt was hospitalized 3 times in February 2003, May 2003 and June 2003 for CHF, atrial fibrillation and ischemic cardiomyopathy. A death certificate and other pertinent record will be sent as soon as available. The investigator assessed the events as unrelated to the study products. Additional info received 10/7/03. There is no hospital summary since subject died at home. Copy of certificate of death received. Cause of death: congestive heart failure-approximate interval between onset and death-5 years. Secondary cause: atrial fibrillation-approximate interval between onset and death-2 years. Other significant conditions contributing to death but not resulting in the underlying cause given-breast cancer. No autopsy performed. A 15-day follow up report received 10/23/2003 adds: No further info is expected. Case is closed.	Y	07/16/2003							N	10/15/2002	07/16/2003	274		UNK	UNK	RSV/Placebo				200301350	1						1	Atrial fibrillation; Cardiac failure congestive; Cardiomyopathy	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0210672	10/21/2003	NY	56.0			M	10/15/2003	From initial info received on 10/14/03 from a health care professional regarding an adverse event occurring, it was reported that a 56 year old male pt received Fluzone SV '2003-'2004, lot U1268AA on 10/10/03 at 12:30pm. One hour later, the pt's legs felt funny and he had difficulty breathing. The pt used albuterol inhalers. He developed a harsh cough throughout the evening and experienced progressive weakness on 10/11/03. The pt went to the ER and was given Benadryl, epinephrine and prednisone. The pt returned to the ER on 10/12/03 after experiencing difficulty breathing and was admitted to the hospital. The recovery status of the pt was not reported. The reporter of this case is also the reporter of case 2003-02308. A 15-day follow up report received 10/23/2003 adds: From additional info received on 10/17/2003 from a health care professional, it was reported that the pt felt achy and weak one hour after receiving the vaccine. 4 1/2 hours later, at 5:00 PM, the pt began coughing and left work to go home. At home, he noted his arms and chest were red and he also experienced chest tightness. He became red all over and was achy. He ate dinner and went to sleep. The following day, the pt stated that he felt a little better, but was still red all over. He went to the ER that night, where he was given Benadryl, prednisone and respiratory therapy for his wheezing. He was then sent home. The next day, 10/12/2003, the pt experienced increased respiratory difficulty and cough and once again went to the ER, where a chest x-ray showed a right upper lobe infiltrate. The pt was admitted to the hospital with a diagnosis of pneumonia. It was not reported whether the pt recovered. Follow up on 05/19/04 states: No further information is anticipated, this case is considered closed.			Y	Y	Y				U	10/10/2003	10/10/2003	0	Chest x-ray: showed a right upper lobe infiltrate (10/12/2003)	UNK	UNK			COPD; Asthma		200302363	1						1	Asthenia; Chest discomfort; Cough; Dyspnoea; Erythema; Feeling abnormal; Pain	FLU3~SANOFI PASTEUR~U1268AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0210675	10/21/2003	RI	39.0	39		F	10/17/2003	2 days after receiving flu vaccine, patient was hospitalized for seizures and a possible stroke. Note that she had taken flu vaccine in the past without reaction. The medical record received on 12/11/03 state tremulous, fatigue, and arm pain. The patient has returned to work and normal activities.				Y	Y				Y	10/08/2003	10/10/2003	2	UNK	OTH	PVT	Flonase	NONE	Benign breast mass, alopecia areola, headaches, decreased appetite.			1						1	Cerebrovascular accident; Convulsion; Fatigue; Pain; Tremor	FLU3~SANOFI PASTEUR~U10766A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0210676	10/21/2003	FL	75.0	75		M	10/14/2003	On 09/30/2003, I visited my MD and had a complete physical with excellent results overall.  I do have controlled high blood pressure via 40 mg Zestril, 25 mg HCT, and 2 mg Cardura 1 day.  On 10/01/2003, I received the flu shot from MD, nurse at which time I did not receive a CDC Vaccine Info Statement-nurse in a rush at other patients in office at that time.  On 10/02/2003, I played 2 hours of Tennis (doubles) with (0) zero ill effects-felt a little muscle aches and another 2 hours tennis (doubles on Saturday, 10/04/2003), but, following that session I really felt ill.  Ie: I experienced intermittent high fever, was very hoarse (almost lost voice entirely) had chills, high heart rate and very high blood pressure (205/115), muscle aches (neck, back and legs), got dizzy each time I stood up or turned around.  I was very weak and each time I ate I broke out in a profuse sweat-also following taking a shower on relieving my bowels all these reactions (?) lasted on a slowly diminishing basis for approximately 7-10 days before I began to actually feel any where near normal again.  I was confused and concerned enough at 3 specific times (during this seige on the nights of 4,5,6 10/03), to consider calling 911, however, I did not.  I did call MD office and reported my plight to his nurse and also to another RN found at cardiovascular clinic (she had been my clinical nurse in an earlier high blood pressure study a couple years ago).  When I felt better I telephoned VAERS and reported this adverse event (using the telephone # indicated on the CDC info statement form my wife had received when she received her flu shot at the clinic. The follow up received on 11/11/3 states, I reported events (adverse) previously I felt too weak to go to emergency room for 2-3 days. My wife nourished me back to normal.									Y	10/01/2003	10/04/2003	3	NONE	PVT	OTH	Zestail, Het, Cardura	NONE	Norvasc			1						1	Asthenia; Blood pressure increased; Chills; Dizziness postural; Dysphonia; Faecal incontinence; Heart rate increased; Hyperhidrosis; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0210677	10/21/2003	AL	50.0	50		F	10/14/2003	10/09/2003: Nausea, dizziness, diarrhea, right arm rubbery, right leg and left foot numb, red, splotchy face, bad taste in mouth, ears felt funny. 10/08/2003: Immediately after vaccine itching, ears felt funny, PMD advised atarax. 10/14/2003: All symptoms much improved.									Y	10/08/2003	10/08/2003	0	NONE	OTH	PUB	Prozac, Synthroid, Ogen, Hyzarrlantus	NONE	Sleep apnea, Diabetec, Demorol morphine, Codeine, Valium, Pneorgen, Vicoxx, MUP, Fibromyalgia, Zantac, Seftin, Cefecel, Novalaine, Lortab, Floven		AL0325	1						1	Diarrhoea; Dizziness; Dysgeusia; Ear disorder; Erythema; Hypoaesthesia; Nausea; Rash macular	FLU3~EVANS VACCINES~765181~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210678	10/21/2003	NY	72.0	72		F	10/16/2003	Cellulitis at injection site.									U	10/15/2003	10/16/2003	1	NONE	PVT	OTH	Lnellral, Liputor, Nextru, Premarin, Ecotrice	NONE	Epipherine phenobarbital			1						1	Cellulitis; Injection site reaction	FLU3~SANOFI PASTEUR~U1124AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1026M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210679	10/21/2003	NY	53.0	53		F	10/17/2003	Swollen right upper arm-tender to touch, area is 10 x 5 inch area-tenderness with arm motion radiating into neck.				Y					U	10/15/2003	10/15/2003	0	NONE	PVT	PVT	NONE	NONE	Hypertension, Diabetes Mellitus, Seasonal allergic rhinitis, Hypothyroid			1						1	Hypokinesia; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U1139AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0865N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210680	10/21/2003	FL	54.0	54		F	10/07/2003	Swelling, erythema, pruritis at site.									Y	10/06/2003	10/07/2003	1	NONE	OTH	OTH	Effexor; Xanax; Zocor; Bextra	NONE	Mentally retarded, Depression			1						1	Injection site erythema; Injection site oedema; Pruritus	FLU3~SANOFI PASTEUR~U1068AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210683	10/21/2003	AL	41.0	41		F	10/10/2003	Red streaks on legs;Difficulty breathing;Heart racing;Sinus Drainage; Several attempts have been made to speak directly with patient. Voicemail messages were left on 10/09/2003, 10/10/2003, 10/13/2003.  No calls have been returned.				Y					Y	10/08/2003	10/08/2003	0	EKG, chest x-ray	OTH	PVT	NONE	NONE	NONE			1						1	Cellulitis; Dyspnoea; Heart rate increased; Rhinorrhoea	FLU3~EVANS VACCINES~765664~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0210684	10/21/2003	IA	59.0	59		F	10/14/2003	Left arm sore 1 hour after shot-tossed and turned at night.  Edismfen of muscle swollen on the day after shot-red, hot, arm and shoulder and back hurts.  Arrigin deltoid region-very red and hot.  Sent to MD.  Achy feeling don't feel good , redness tender to neck.  10/15/2003: Ill today.  Didn't see MD yesterday, just went home.  Today called MD and he was not in.  Has diarrhea today, still achy, has headache, arm very sore, still a little red but not bright red and dies non-extended up neck like yesterday.  Still planning on seeing MD to follow up with another MD if can't see primary MD. Denies illness prior to flu shot.  I'm never sick.  10/16/2003: Back at work, feeling better now, arm not swollen, only a little pink, soreness much better.  Did not see MD at her own decision.				Y					Y	10/13/2003	10/14/2003	1	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Back pain; Headache; Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLU3~EVANS VACCINES~765853~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0210685	10/21/2003	CA	42.0	42		F	10/09/2003	Nausea, vomiting, diarrhea, fever 101.4, whole body ache, heat at injection site.				Y					U	10/07/2003	10/08/2003	1	NONE	PUB	PVT	NONE	NONE	NONE			1						1	Diarrhoea; Injection site warmth; Nausea; Pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1256AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210686	10/21/2003	CA	78.0			F	10/09/2003	Redness/swelling at site of injection within 4-5 hours after injection. Instructed by MD to apply ice pack, take tylenol if needed.									Y	10/08/2003	10/08/2003	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1093AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210687	10/21/2003	WI	62.0	62		M	10/14/2003	10/13/2003 @ 9:30 AM: Started to swell at 14:00.  Swelling from shoulder to elbow.  Hot to touch red, pain.									Y	10/13/2003	10/13/2003	0	NONE	PUB	PUB	Inhaler	NONE	Asthma-severe			1						1	Injection site erythema; Injection site oedema; Injection site warmth; Pain	FLU3~SANOFI PASTEUR~U1140AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0740N~3~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210688	10/21/2003	CT	17.0	17		M	10/15/2003	10 after injection, numbness left arm radiating to neck, numbness included throat, head (+) difficulty breathing, arm appeared red and swollen.				Y					Y	10/14/2003	10/14/2003	0	NONE	PVT	OTH	NONE	NONE	ALLERGIC PCN			1						1	Dyspnoea; Hypoaesthesia; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1145AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210690	10/21/2003	MI	57.0	57		M	10/20/2003	Fever 99.3; pharyngitis productive cough, chest pain. Prescribed keflex 500 mg 3 times a day for 7 days.									Y	10/14/2003	10/17/2003	3	CXR	PVT	PVT	HBP MEDS	NONE	HBP			1						1	Chest pain; Cough; Pharyngitis; Pyrexia	FLU3~SANOFI PASTEUR~U1087AA~3~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210691	10/21/2003	PA	18.0	18		F	10/14/2003	Began to get red blotches that turned into hives with severe itching. Called the d/o and spoke with receptionist.  Was told to take 2 Benadryl and wait to see if the itching dissipated.  Took the Benadryl a within 2 hours symptoms gone.									Y	10/13/2003	10/13/2003	0	NONE	PVT	PUB	Combivent/Darvocet	NONE	Asthma, Migrane headaches			1						1	Erythema; Pruritus; Rash macular; Urticaria	FLU3~SANOFI PASTEUR~U1088AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210710	10/21/2003	CA	0.8	0	.8	M	10/21/2003	Diffuse urticaria				Y					Y	10/02/2003	10/02/2003	0		PVT	PVT	None	None	None			1						1	Urticaria	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210725	10/21/2003	IN	65.0	65		F	10/16/2003	8 1/2 x 10cm lump RVE inner aspect of arm above elbow, slightly warm and slightly pink (pt reports slightly warm and red on 10/15/03). Area is not located at injection site.				Y					U	10/13/2003	10/14/2003	1		PVT	PVT	Estraderm, Pietal, ASA, Duratuss, Periactin, Limbitrol	Strep throat	Fibromyalgia, GERD			1						1	Feeling hot; Injection site erythema; Injection site mass	FLU3~SANOFI PASTEUR~U1074AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0675M~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210829	10/21/2003	CO	39.0	39		F	10/21/2003	Pt received flu shot at work by Maxim health care nurses in flu shot clinic, no previous h/o problems or reactions to flu shot. Pt notes receives every year, no allergies to eggs.  40 min post injection, started with puritis and urticaria.  Treated in my office.				Y					Y	10/20/2003				UNK	PVT		None	Fibroids			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1076AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210834	10/21/2003	IL	59.0	59		F	10/21/2003	Received flu vaccine October 16,2003 around 5:30 PM.  Around Noon the next day began to feel achy - all over. Denies fever.  Saw her MD Monday 10-20-2003.  He ruled out meds and other causes per client and told her it was from the flu vaccine.  Client still has aching today, but feels it is improving.  Has had flu vaccine before without problems.				Y					U	10/16/2003	10/17/2003	1	Denied having any tests done	PUB	PUB	Unknown	None	None			1						1	Pain	FLU3~EVANS VACCINES~765796~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0210836	10/21/2003	VA	4.0	4		F	10/21/2003	Pt was given influenza vaccine on 10/17/03 then noted to have some reddness and swelling of the right thigh around the vaccination site on 10/18/2003.  Parents spoke with doctor on call that day and then came in for office visit on 10/20/2003 as instructed.  She continued to have a swollen/red/hot/tender right thigh with surrounding the vaccination site.  Pt did have some limping in the first couple days but otherwise was acting and playing normally.				Y					U	10/17/2003	10/18/2003	1		PVT	UNK		none	History of Febrile Seizures			1						1	Gait disturbance; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~EVANS VACCINES~765179~4~IM~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0210839	10/21/2003	WY	73.0	73		F	10/21/2003	Chilling, shivering, fever, headache, muscle ache for 12 hours, followed by 12 hours of extreme weakness.  A follow up report received 10/28/2003 adds: No Rx, no Dx.									Y	10/16/2003	10/17/2003	1	none	PUB	PUB		None	None			1						1	Asthenia; Chills; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1122AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210840	10/21/2003	VA	37.0	37		F	10/21/2003	8/10 sudden-onset frontal sinus headache approx. 4 hours after administration of YF & flu vaccines(and immediately following 1.5 mile run).  Decreased to 4/10 after 500mg Tylenol, but headache was still present 7 hours after onset.  No hx of rxn to flu vaccines or cephalgia following physical activity.									Y	10/19/2003	10/19/2003	0		MIL	MIL	sam-E (OTC); daily MVI	None	seasonal grasses, neomycin, clotrimazole			1						1	Cluster headache	FLU3~SANOFI PASTEUR~U1098AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|YF~SANOFI PASTEUR~UV396AA~1~SC~LA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0210764	10/22/2003	CA	0.78	0	.8	F	10/20/2003	Patient received influenza .25cc on 10/7/03 and also received Synagis same day. No illness/fever reported. Patient put to bed; last checked at 3AM 10/08. Found dead in crib on 10/8 about 9 AM. No autopsy done. Hospital discharge summary received on 11/21/03 states cardiopulmonary arrest. Death Certificate received on 10/29/2003 states pneumonia and chronic lung disease.	Y	10/08/2003							N	10/07/2003	10/08/2003	1	NONE	PVT	OTH	Albuterol; Lasix; Pulmicort; KCL; Iron	NONE	Chronic lung disease; Recurrent pneumonia; Microcephaly; Developmental delay			1						1	Cardiac arrest; Lung disorder; Pneumonia	FLU3~SANOFI PASTEUR~UI078AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0210765	10/22/2003	MA	51.0	51		M	10/21/2003	6:30 PM felt chills, aches, headache throughout night-chills. Several bouts diarrhea Wed and Thurs, missed 1 day work.									Y	10/15/2003	10/15/2003	0	NONE	OTH	PVT			NONE			1						1	Chills; Diarrhoea; Headache; Pain	FLU3~SANOFI PASTEUR~U1068AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210775	10/22/2003	IN	5.0	4		M	10/14/2003	Pt c/o itching and then vomited and became pale lethargic and could not stand up. The medical record received on 2/10/04 states abdominal pain. Medical record states allergy, myalgia. msv				Y	Y	1			Y	10/13/2003	10/13/2003	0	Test abnormal	PVT	PVT	Digoxin; Carvedilol; Lasix; Reglan; Coumadin; Vasotec; Aldactone; Zantac	Muscular pain	Hypoplastic left heart, allergy, regurgitation			1						1	Abdominal pain; Laboratory test abnormal; Lethargy; Myalgia; Pallor; Pruritus; Vomiting	FLU3~SANOFI PASTEUR~U1136AA~6~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0210777	10/22/2003	TX	25.0	25		M	10/21/2003	Myopericarditis. Patient cared for by doctor involved in ? pertaining to myocarditis status post smallpox vaccine.					Y	3			U	10/13/2003	10/15/2003	2		MIL	MIL	NONE	NONE	NONE			1						1	Myocarditis; Pericarditis; Back pain; Chest pain; Chills; Dizziness; Dyspnoea; Hyperhidrosis; Injection site pustule; Laboratory test abnormal; Nausea; Palpitations; Pericarditis; Pharyngolaryngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1|FLUX~UNKNOWN MANUFACTURER~765141~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|SMALL~PFIZER\WYETH~4020071~1~SC~LA~SMALLPOX (DRYVAX)~2|TYP~SANOFI PASTEUR~W0909~2~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~2	USA	Hospitalisation	Influenza
0210778	10/22/2003	KY	57.0	57		F	10/21/2003	For 3 days: loss of balance, nausea, dizziness.									Y	10/15/2003	10/16/2003	1		PUB	PVT	Lipitor	NONE	NONE			1						1	Balance disorder; Dizziness; Nausea	FLU3~SANOFI PASTEUR~U1140AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210779	10/22/2003	ME	77.0	77		M	10/17/2003	Edema and erythema to right extremity (in entirety) within several hours of vaccine with gradual increase in severity involving entire distal extremity. Tx elevation, ice, compress and Keflex tid.									Y	10/15/2003	10/15/2003	0		PVT	PVT	Hytrin, Norvasc, Proslar	NONE	HTN, BPH, tobacco abuse			1						1	Injection site erythema; Injection site oedema	FLU3~EVANS VACCINES~765703~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1026M~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210780	10/22/2003	NE	40.0	40		F	10/13/2003	Local swelling at injection site about 2 diameter. Hives on face, legs and itching face, arms, legs. Slightly thick feeling in throat, back of pharynx. Give Benadryl 25mg po at about 13:15.									Y	10/13/2003	10/13/2003	0		PUB	PUB	Hormone replacement, thyroid/Synthroid	NONE	Environmental allergies; Hypothyroidism; S/P pan hysterectomy			1						1	Injection site oedema; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1135FA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210781	10/22/2003	MI	51.0	51		F	10/15/2003	Itching, raised and warm whelts, started on injection arm and chest 6 hours after vaccine, 24 hours after whelts on stomach, back, shoulders, neck. Felt fluish, feverish, sore throat, headache, achey, tired, little nauseous. Had Benadryl 25mg, 2 Tylenol x-strength in ER at 10:30 AM, then 50 mg Benadryl every 4-6 hours till next AM. Oct 9: felt better, little tired, went to work. 10/10/03: still having occasional hives popping up randomly in different areas.				Y					Y	10/07/2003	10/07/2003	0	NONE	PUB	UNK	Humalog, Horvasc, Nexium, Premarin, Toprol XL, Altace, Hydroflorothiazide, Zetia, multi vitamin, fish oil	NONE	Diabetic, CAD, Allergy-aspirin, monopril, Celebrex. Also Leukopenia diagnosed.			1						1	Fatigue; Feeling hot; Headache; Influenza like illness; Injection site swelling; Nausea; Pain; Pharyngolaryngeal pain; Pruritus; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U1253AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210782	10/22/2003	CO	22.0	22		F	10/17/2003	Worked until 5:30 PM as Infant/Toddler Childcare staff. 5:45 PM attended exercise class, began stretching because back felt stiff, sudden onset of sharp pains in upper back under scapula. Difficulty sleeping that night, treated with ibuprofen and heat with some relief. Called to report pain, advised to call Public Health. No other symptoms such as wetness, rash, vomiting.				Y					U	10/15/2003	10/15/2003	0		PUB	PUB	Alesse	NONE	NONE			1						1	Back pain; Insomnia	FLU3~SANOFI PASTEUR~U1091AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210783	10/22/2003	CA	80.0	80		M	10/16/2003	Pt c/o skin redness, SOB and nausea. Taken to urgent care by wheelchair.				Y					Y	10/09/2003	10/09/2003	0		PVT	PVT						1						1	Dyspnoea; Injection site erythema; Nausea	FLU3~SANOFI PASTEUR~U1088AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210784	10/22/2003	WA	4.0	4		M	10/15/2003	Pt got shots in our office last week in the evening and by the next AM, his left leg was very swollen. I can't even see his knee. We brought him back to see Dr. Dx: acute local reaction to DTaP.				Y					N	10/13/2003	10/14/2003	1		PVT	PUB	Atarax		Amoxicillin allergy-rash/molluscum contagiosum/dyshydrosis			1						1	Injection site oedema	DTAP~SANOFI PASTEUR~C1385AA~5~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1069AA~4~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~759A2~2~IM~RL~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~W0906~4~SC~RL~POLIO VIRUS, INACT. (POLIOVAX)~1	USA	Emergency room visit	Influenza
0210785	10/22/2003	IL	28.0	28		F	10/15/2003	Pain in right shoulder, arm, neck. Tingling in right arm and hand. Felt pain in neck and arm when vaccine was injected. Will see a Dr if numbness does not resolve in 7-10 days.									N	10/09/2003	10/09/2003	0		OTH	OTH	NONE	NONE	Hayfever			1						1	Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U1135FA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210786	10/22/2003	AZ	24.0	24		F	10/17/2003	Experienced body aches, congestion, weakness, nausea 72 hours post vaccination.									Y	10/14/2003	10/17/2003	3	NONE	OTH	PVT	Valporic acid	NONE	Epilepsy; allergy to Tegretol			1						1	Asthenia; Nasal congestion; Nausea; Pain	FLU3~SANOFI PASTEUR~U1266AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210787	10/22/2003	MI	79.0	79		F	10/16/2003	Left arm from elbow to shoulder very red, swollen, warm and tender to touch. C/o numbness and tingling in left forearm. Fever reported evening after received injections. Pt presented at clinic today with above symptoms. Seen by Dr and given Rx for prednisone. Awaiting outcome. Pt to be seen for follow-up evaluation on 10/20/03.				Y					U	10/14/2003	10/14/2003	0		PVT	UNK	Albuterol, Atrovent, Advair, HCTZ, KCl, Lisinopril		COPD, HTN. Allergy listed: hydrogen peroxide causes itching			1						1	Feeling hot; Hypoaesthesia; Injection site erythema; Injection site oedema; Pain; Paraesthesia; Pyrexia	FLU3~EVANS VACCINES~765670~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0541~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210788	10/22/2003	UT	67.0	67		F	10/14/2003	Hematoma left arm after injection of flu shot.				Y					Y	10/09/2003	10/09/2003	0		PUB	PVT		NONE	CAD, MI 1997, HTN			1						1	Injection site haemorrhage	FLU3~EVANS VACCINES~765797~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0210789	10/22/2003	TX	62.0	62		M	10/15/2003	Shot administered 10/3/03. Arm started swell and hurting very bad Friday night. Sat morning arm was swollen and very red/hot. Sun morning arm was swollen, ? towards wrist. Monday went to Dr, he prescribed anti-inflammatory and Benadryl.				Y					Y	10/03/2003	10/03/2003	0		PVT	PVT	Allopurinol, Zestril, Zocor, Prilosec	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site warmth; Pain	FLU3~EVANS VACCINES~765667~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0210793	10/22/2003	WV	15.0	15		F	10/15/2003	Swelling left deltoid with pain, no erythema.				Y					U	10/14/2003	10/15/2003	1	NONE	PVT	PUB	Zyrtec, Proventil, Rhinocort, Ibuprofen, Zoloft, Orthotricycline	NONE	Environmental allergies			1						1	Injection site oedema; Pain	FLU3~SANOFI PASTEUR~U1089AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210794	10/22/2003	SC	68.0	68		F	10/17/2003	Received pneumodical vac sub q right arm. Pt reports swelling, redness, pain started 10/16/03 PM. Today arm red from elbow up arm, very warm to touch, swollen around elbow area.									U	10/16/2003	10/16/2003	0		PUB	OTH						1						1	Feeling hot; Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U1145AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0445M~2~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210823	10/22/2003	VA	70.0	70		F	10/21/2003	Bruise-deep purple approximately 2 by 3 circular area below injection site L arm below deltoid muscle but above elbow. Bruised area was surrounded by one inch red margin. No pain was noted. C/O swelling-none on injection. Bruises still there decreased redness.									U	10/15/2003	10/15/2003	0		OTH	PUB	UNK	NONE	UNK			1						1	Contusion; Injection site erythema; Oedema	FLU3~SANOFI PASTEUR~U1269AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210824	10/22/2003	OH	43.0	43		F	10/21/2003	Received vaccine at 0800-hot flash, flushing, rash, little spoits, -EMS called-observed-no treatment-pt remained at work-was symptom free at 1000.									Y	10/21/2003	10/21/2003	0	NONE	OTH	PVT	Diaspan; Actos; Tricor; Lipitor	NONE	High lipids, diabetes			1						1	Flushing; Hot flush; Rash	FLU3~SANOFI PASTEUR~U1147AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210844	10/22/2003	MS	69.0	69		M	10/15/2003	Gave Pneumo vaccine in Left deltoid muscle IM. Deltoid are aswollen and warm to touch, no blistering or broken skin.  Client stated it feels like I have been burned, like it ahas a blister.  Client advised to take antiinflammatory as needed.  If swellling and fever continueu, see PMD or ER.									U	10/13/2003	10/13/2003	0	None	PUB	PUB	ASA	none	PCN, codeine, sulfa		MS 03 082	1						1	Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1271AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0872m~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210845	10/22/2003	MS	64.0	64		F	10/16/2003	Client in today 10/16 complaining of sore, redness, hot to touch from Pneumococcal vaccination on 10/14/03.  Client reports  pain upon elevating arm. Advised client to see PMD or ER if problem persists.									Y	10/14/2003	10/15/2003	1	none	PUB	PUB	pepcid, tylenol, estrace, viox glucose	none	none		MS03083	1						1	Injection site erythema; Injection site pain; Injection site warmth; Joint range of motion decreased	FLU3~SANOFI PASTEUR~1281AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0872M~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210848	10/22/2003	KY	24.0	24		F	10/15/2003	Red circle about 50-cent in size, raised, slight brusing at needle entry site.									U	10/13/2003	10/13/2003	0		PVT	PVT	Tri-vora, Flonase	N/A	Enviormental allergies		KY2003093	1						1	Contusion; Erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U1139AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210849	10/22/2003	OH	22.0	22		F	10/16/2003	Rt upper arm with 80mm redness, firmness, mod swelling, afebrile c/o body aches									Y	10/14/2003	10/15/2003	1	n/a	PVT	PVT		none	asthma, diabeties, autoimmune hepatitis, hypertention.		KY2003094	1						1	Erythema; Injection site induration; Injection site swelling; Pain	FLU3~SANOFI PASTEUR~U1139AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210853	10/22/2003	IL	46.0	46		F	10/22/2003	I was sick to my stomach before leaving for work and had to leave work after 2hrs due to feeling sick to my stomach again.  Vomitted on the way home in my car.  Still feel sick to my stomach  during the day of 10/22/03.									N	10/20/2003	10/21/2003	1		UNK	PUB	Insulin.	None	Diabetic. Penicillin allergy.			1						1	Stomach discomfort; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0210885	10/22/2003	VT	0.0			M	10/22/2003	MUSCLE ACHES AND PAIN, GENERAL MALAISE AND EXTREME  WEAKNESS.OUT OF WORK FOR 3 1/2 DAYS. HAD HAD VACCINE TWICE BEFORE AND HAD MODERATE LOCAL REACTIONS WITH ARM SWELLING AND PAIN.									Y	10/07/2003	10/08/2003	1	NONE KNOWN	PUB	PUB	UNKNOWN	UNKNOWN	UNKNOWN			1						1	Asthenia; Myalgia; Pain; Swelling	FLU3~EVANS VACCINES~765748~3~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210886	10/22/2003	NM	10.0	10		M	10/22/2003	Parent reported within one hour of getting flu vaccine, developed raised, red, itchy rash and in the following hour, the rash was worse.									Y	10/20/2003	10/20/2003	0	None	PVT	UNK	Albuterol Flovent	RAD	allergic rhinitis			1						1	Pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~41099AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210887	10/22/2003	MO	14.0	14		M	10/22/2003	Pt. c/o itching and hives on back, torso and arms Sunday 10/12/03 at aprox. 10:00am.  Pt was given Benadryl by his parents on Suday at aprox. 10:00 am and parent-pt- reports that pt noticed a decrease in itching and hives.  Pt along with father presents today 10/14/04 at 9:00am with c/o of red raised areas  noted on Rt upper arm and upper back.  Encouraged parent to take pt to Doctor.  10/22/03 T.C. to fatherl and he reports that child was seen by Dr. on 10/16/03 and was put on Alegra180 mg one tablet x4days.  Father of child reports hives gone on 10/18/03.				Y					Y	10/09/2003	10/12/2003	3	none	PUB	UNK	none	none	none			1						1	Pruritus; Rash erythematous; Urticaria	FLU3~SANOFI PASTEUR~U1260AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210888	10/22/2003	MO	56.0	56		M	10/22/2003	Minimal soreness at site with injection. Next day had Flu like symptoms, he stated. Muscles ached all over , chills, and fever. Missed 1 day of work. Better, but still feels achy at present, 5 days post vaccination. Resolving slowly.									Y	10/17/2003	10/18/2003	1	None. Pt. stated didn't visit a Physician or take any medications for his symptoms.	MIL	MIL	Zantac (Stomach acid) Expril (BP med) Lipitor (cholesterol) EC ASA (Hx MI) Vitamins- Multi, E, B6	Seasonal sinus problem with clear sinus drainage in throat, no cough, no fever, or feel ill otherwise.	Hx of sinus problems with seasonal allergies. Hx of MI 4 yr.s ago. NKA to Medications or egg/products. Seasonal allergy to molds.			1						1	Chills; Influenza like illness; Injection site pain; Myalgia; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1098AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210890	10/22/2003	MO	67.0	67		M	10/21/2003	Wife called 10-15-03 and stated that patient right arm was red, swollen, hot and painful from deltoid to elbow.  Advised the use of heat and ibuprofin and call doctor if not better tomorrow.  Called 10-16-03 and is less painful, less swollen, and red.  Wife states it is much better than yesterday.									Y	10/14/2003	10/14/2003	0		PUB	UNK					MO200385	1						1	Erythema; Injection site warmth; Pain; Swelling	FLU3~SANOFI PASTEUR~U1103AA~1~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0068M~1~ID~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210856	10/23/2003		75.0			F		A report was received from a consumer on 10/10/2003 concerning a 75 year old female pt who experienced aches, (2 days after receiving Fluvirin on 10/02/2003), sore throat, congestion, and cough 3 days after vaccination and passed out and had tremors an unspecified length of time after vaccination and was hospitalized on 10/09/2003. On 10/04/2003 the pt experienced aches and then on 10/05/2003 the pt experienced flu symptoms including aches, congestion, sore throat and coughing but no fever. The pt contacted a hospital and was advised to take ibuprofen. She also took saline nasal drops for nasal congestion, menthol, camphor and eucalyptus oil applied topically at bedtime, and zinc salts every 6 hours for symptom relief. On 10/09/2003 the pt's symptoms worsened. Diazepam, chlorpheniramine, paracetamol and Protothazine with dextromethorphan were prescribed by the pt's physician. The pt passed and had tremors. Paramedical personnel treated the pt with diphenhydramine and she was taken to hospital. The pt had returned home at the time of the report. The pt had not recovered at the time of the report. No follow up. Permission not granted to contact treating physician.			Y	Y	Y				U	10/02/2003	10/09/2003	7		UNK	UNK	Concomitant drugs not reported.				PJP200300794	1						1	Cough; Influenza like illness; Loss of consciousness; Nasal congestion; Pain; Pharyngolaryngeal pain; Tremor	FLU3~EVANS VACCINES~765501~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0210865	10/23/2003	NJ	4.0	4		M	10/17/2003	10/15/03 9:05 left arm 3 redness/swelling. 10/15/03 2:55 left arm 4 redness/swelling. 10/16/03 9:20 left arm 5-6 redness/swelling. Mother taking child to ER. Had steroid injection and placed on Augmentin in ER-swelling gone, redness gone.				Y					Y	10/14/2003	10/15/2003	1		PVT	PVT	NONE	NONE	Reactive airway disease			1						1	Erythema; Oedema peripheral	DTAP~SANOFI PASTEUR~U1007DA~5~~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1097AA~3~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W1624~4~~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0297N~2~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0210868	10/23/2003	PA	4.0	4		M	10/17/2003	L arm swollen, red, itchy, no pain no fever. Red ring present around immun. site. Was on Amoxicillin far OM and switched to Augmentin po bid.				Y					U	10/15/2003	10/16/2003	1		PVT	PVT		Recovering OM				1						1	Erythema; Injection site erythema; Oedema peripheral; Pruritus	FLU3~SANOFI PASTEUR~U1139AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210876	10/23/2003	IA	77.0	77		F	10/22/2003	Vaccine given 10/21/03 AM Pt complaint right arm hurt and swollen. 10/21 PM Pt came in store. 10/22/03 AM right arm (upper) was swollen red tender and had fluid. Looks like cellulitis. Sent pt to urgent care.				Y					U	10/21/2003	10/21/2003	0		OTH	OTH	NONE	NONE	NONE			1						1	Cellulitis; Injection site erythema; Injection site oedema; Pain	FLU3~SANOFI PASTEUR~U1253AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0864N~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210877	10/23/2003	IA	39.0	39		M		Dizziness 6:00 PM. Nausea/vomiting 7:00 PM.				Y					Y	10/20/2003	10/20/2003	0	NONE	PUB	UNK		NONE	NONE			1						1	Dizziness; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U107488~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210878	10/23/2003	ME	54.0	54		M	10/22/2003	Pt was given flu vaccine at 9:45 AM. He waited for his wife and after she had her shot at 10:30 they waited together until 11 AM when he told her as they were leaving he did not feel well. He was feeling faint. He was diaphoretic, c/o dyspnea and numbness in his left arm. 80/60, P 60, Resp 24. Pt was taken to ER via ambulance. He had Benadryl IV, ? 1 minute. Stayed for observation for awhile and then was discharged. Today 10/22/03 at work feels over 70% of functioning and not feeling that good yet. Has Benadryl to take if needs it.				Y					Y	10/21/2003	10/21/2003	0	NONE	PUB	UNK	Depakote, Dilantin, Tegretol	NONE	Allergy to penicillin; seizure disorder due to GSW			1						1	Dizziness; Dyspnoea; Hyperhidrosis; Hypoaesthesia; Malaise	FLU3~SANOFI PASTEUR~U1269AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210879	10/23/2003	OH	50.0	50		M	10/20/2003	Pt called clinic complaining of shortness of breath, frequent coughing to point he could not talk, and chest heaviness. Pt stated he had been experiencing these symptoms for 90 minutes. Pt reported he had none of these symptoms prior to receiving influenza vaccine.				Y					Y	10/14/2003	10/14/2003	0		OTH	OTH	Albuterol inhalerr, Bactrim, Viagra, Flurisolide nasal spray, Nortriplyline, Divalpro, Actifed	Sinus infection with secondary asthmatic bronchitis and underlying allergies	Smokes 1/2 pack per day, allergic rhinitis			1						1	Chest pain; Cough; Dyspnoea; Chest pain; Cough; Dyspnoea	FLU3~SANOFI PASTEUR~U1268AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1268AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0210880	10/23/2003	OH	62.0	62		M	10/20/2003	Pt complained of shortness of breath 15 minutes after influenza vaccination. This was relieved with oxygen 2L. Pt also developed large indurated bump, bigger than golf ball, tender to touch 15 minutes after vaccination. 20 minutes after vaccination the indurated bump was 4 cm in diameter. Pt sent to ER.				Y					Y	10/20/2003	10/20/2003	0		OTH	OTH	Vicodin, Albuterol nebulizer, Ipratroprium nebulizer, Daritidine, Gabaputin, Hydroxyzine	NONE	Fatty liver, hyperlipidemia, peripheral neuropathy, COPD			1						1	Dyspnoea; Injection site induration; Injection site oedema; Injection site swelling; Pain	FLU3~SANOFI PASTEUR~U1145AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210881	10/23/2003	MI	41.0	41		F	10/22/2003	Raised, red warm to touch. Tender lesion approx 3 cm in size, round at site of injection.				Y					Y	10/20/2003	10/22/2003	2	NONE	PVT	PUB		NONE	Allergies-environmental, diabetes			1						1	Feeling hot; Pain; Rash erythematous; Skin ulcer	FLU3~SANOFI PASTEUR~U1141AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210882	10/23/2003	CA	73.0	73		M	10/22/2003	Sterile cellulitis LVE, red, indurated with +3 edema extending to wrist from sites of immunizations in deltoid.				Y					Y	10/14/2003	10/15/2003	1	NONE	PVT	PVT	Lotrimin, Lipitor	NONE	HBP, dyslipidemia			1						1	Cellulitis; Injection site oedema	FLU3~SANOFI PASTEUR~U1068AA~6~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MUR~MERCK & CO. INC.~0740N~2~IM~LL~MUMPS + RUBELLA (FOREIGN)~1	USA	Emergency room visit	Influenza
0210944	10/23/2003	SC	62.0	62		M	10/23/2003	Symptoms started 24 hours later.  Lasted 36 hours.  Took Tylenol. 1 - fever, chills 2 - joint stiffness 3 - extreme tenderness 4 - left upper arm showed hot, reddened area -   approx. 4x5									Y	10/17/2003	10/18/2003	1		PUB	PUB	Takes arthritis and B/P medications	None	Arthritis and high B/P		SC0339	1						1	Injection site erythema; Injection site pain; Injection site warmth; Joint stiffness; Pyrexia	FLU3~SANOFI PASTEUR~U1260AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0445M~1~SC~LA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U0991AA~3~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0210945	10/23/2003	SC	45.0	45		F	10/23/2003	Received Td in right deltoid - arm swollen, red area - 2x3 Received PPV23 - left arm - swollen, warm and red									Y	10/20/2003	10/20/2003	0		PUB	PUB	None	NONE	NONE		SC0340	1						1	Feeling hot; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1260AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~O445M~1~SC~LA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~Uo991AA~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0210947	10/23/2003	KS	4.0	56		F	10/23/2003	Notice site warm, red, swollen day after injection									Y	10/21/2003	10/22/2003	1		MIL	MIL	Zocor, Aciphex, Atenolol, Doxipen Vioxx	None	Htn, Hypercholesterolemia, Arthritis			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~u1098AA~1~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210948	10/23/2003	FL	53.0	53		F	10/23/2003	5-6 hours after administration - Developed sore arm with erythema at site of injection developing over next several hours to cover upper 1/2 of front of upper arm with swelling to elbow.  Developed swelling of tongue with small blister type formation and upper respiratory congestion.  Mouth swelling resolved within 12 hours with respiratory congestion for 24 hours and upper arm developing mild cellulitus - Bendryl given over first 24 hours with antibiotic (Keflex) for arm - Missed 2 days of work				Y					Y	10/07/2003	10/07/2003	0	None	UNK	PVT	BP Medication Ziac	None	Hypertension			1						1	Blister; Cellulitis; Injection site erythema; Injection site oedema; Injection site pain; Nasal congestion; Tongue oedema	FLU3~SANOFI PASTEUR~U1270AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210949	10/23/2003	FL	32.0	32		F	10/23/2003	Within 4 hours of administration developed local reaction of erythema with progession of site to cover upper 1/3 third of upper arm with swelling to elbow.  Developed swelling at back of throat with upper respiratory congestion lasting approxmiately 2 days.  Given Benedryl for symptoms				Y					Y	10/16/2003	10/16/2003	0	None	UNK	PVT	Ansyn-BP Medication	None	Asthma - Hypertension			1						1	Injection site erythema; Injection site oedema; Nasal congestion; Tracheal oedema	FLU3~SANOFI PASTEUR~U1270AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210950	10/23/2003	WY	37.0	37		F	10/23/2003	Flu vaccine administered around 4:15pm. Around 4:25pm, pt. reported hand tingling and racing heart. BP144/100 Pulse 92. Lungs clear. Pt. reported feeling worse. States breathing became more difficult, and throat felt like it was closing. Per protocol,.5cc adrenaline administered s.q. Oxygen 2 liters administered at 4:35pm. Pulse 100 Pt. still reported throat tightness and was transported to emergency room				Y					Y	10/22/2003	10/22/2003	0	Was monitored in ER, then released	PUB	PUB						1						1	Dyspnoea; Heart rate increased; Paraesthesia; Throat tightness	FLU3~SANOFI PASTEUR~Ap U1277AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210951	10/23/2003	NJ	39.0	0	.6	F	10/23/2003	received shot on Friday by Monday night had 101 temp.  Chills, Headache, body aches, fever reached 102.6  called Dr. received Zithromax. Every syptom of the flu.  Now have cough. Out of work 2 days (should have stayed out longer, couldn't).									Y	10/17/2003	10/20/2003	3	Received Inactivated Influenza Vaccine 5/6/03 at my job Gusmer, 1 Gusmer Dr. Lakewood, NJ 08701 #13 may not be accuracte I could not find this in the drop down list.However I kept the paperwork given by our Human Resource dept.	UNK	UNK	Birth control		allergic to sulfur			1						1	Headache; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~2~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0210952	10/23/2003	NJ	18.0	18		U	10/23/2003	One hour after injection of pneumovax into the deltoid- patient had significant local swelling.  This progressed to the point of severe deltoid swelling and pain, and inability to move the arm without pain.  It was warm/red.  Required prednisone for therapy (pt is allergic to benadryl)				Y					U	10/15/2003	10/15/2003	0		PVT	PVT	aleve prn, zantac prn, albuterol prn, vit C, flaxseed oil qd	increased GERD, and some sore throat	ALl- pcn, benadryl, codeine. PMH-high chol, TMJ, migraines, carpal tunnel, GERD, oral ulcers, asthma, cervical dysplasia			1						1	Feeling hot; Hypokinesia; Injection site erythema; Injection site oedema; Injection site pain	FLU3~EVANS VACCINES~785161~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1026M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210954	10/23/2003	MI	37.0	37		M	10/23/2003	Approximatelt an hour after injection, I experienced some dizziness and a change in vision.  The peripheral vision was distorted (kind of a tunnel vision).  I waited it out.  After about two hours, the dizziness subsided and the vision returned to normal.									Y	10/23/2003	10/23/2003	0		UNK	PVT	Advair 100/50, Pravachol 20mg, Cefadroxil 500mg	A possible skin infection at a wound received about 1 month ago. (Reason for Antibiotic)	Asthma, High Cholesterol  (P.S. Where's the instructions?)			1						1	Dizziness; Visual disturbance	FLU3~EVANS VACCINES~765709~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210955	10/23/2003	NY	38.0	38		M	10/23/2003	Hives and itching of the eyes third and forth day after vaccine administered.									U	10/18/2003	10/22/2003	4		MIL	UNK		NONE	NONE			1						1	Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0210568	10/24/2003	NC	56.0	56		F		As the needle injected was being removed from arm, pt began to bleed and bruise around area of injection about 1 in diameter, and slight swelling occurred. Pt felt fine, we gave benadryl oral and watched for a while, asked about meds she may be on such as coumadin or ASA, she wasn't on any. Advised her on what to do if swelling started again. And we called later that evening to see what the status of her condition was and she was fine.									Y	10/14/2003	10/14/2003	0		UNK	UNK		NONE	No allergies			1						3	Contusion; Injection site oedema; Contusion; Injection site oedema; Contusion; Injection site oedema	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U12708A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA		Influenza
0210896	10/24/2003	PA	68.0	68		M		This subject is a 69 year old male who died of natural causes while enrolled in RSV S & I study. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/9/02. The subject died 255 days post immunization on 6/21/03. The death was reported by the investigator as not related to the study vaccine. Cause of death was not reported. Additional info is requested. Subject developed a cough, chest congestion and SOB 30 days post immunization and was admitted to the hospital on 11/8/02. A chest x-ray showed patchy bibasilar infiltrates superimposed upon fibrotic changes. Treatment included IV Solumedrol, antibiotics, Levaquin, Lanoxin, Surfak, and oxygen. The subject recovered and was discharged from the hospital six days later on 11/14/02. The event of an acute exacerbation of COPD was reported by the investigator as unrelated to the study vaccine. A 15-day follow up report received 11/13/2003 adds: Additional info received 10/21/2003: Copy of Death Certificate dated 06/25/2003. Cause of Death: Emphysema, due to tobacco abuse, coronary artery disease, insulin dependent diabetes mellitus. No autopsy was performed.	Y	06/21/2003							N	10/09/2002	06/21/2003	255		UNK	UNK	Placebo/RSV, NPH and Humulin-R insulin, Humabid LA, Digitek, potassium chloride, Theophylline, Zyrtec, Aspirin, Protonix, Lisinopril, Imdur, Lasix, Flonase, Serevent, Atrovent, Albuterol, Flovent, and Prednisone.		Chronic obstrictive pulmonary disease; Congestive heart failure.  Information from previous hospitalization received 11/11/2002: Past medical history includes:  Congestive heart failure, which requires oxygen at 3 L/m at night, Type 1 Diabetes, Coronary Artery Disease, chronic sinusitis, hypertension, hearing loss, T & A, cholecystectomy, left orchiectomy, ventral hernia repair and a benign colon polyp removal.  The subject is a former smoker.  Subject developed a cough, chest congestion and shortness of breath 30 days post-immunization and was admitted to the hospital on 11/08/2002.  A chest x-ray showed patchy bibasilar infiltrates superimposed upon fibrotic changes.  Treatment included intravenous Solumedrol, antibiotics, Levaquin, Lanoxin, Surfak and oxygen.  The subject recovered and was discharged from the hospital six days later on 11/14/2002.  The event of an acut exacerbation of chronic obstructive pulmonary disease was reported by the Investigator as unrelated to the study vaccine.		200302373	1						1	Condition aggravated; Cough; Dyspnoea; Emphysema; Lung disorder; Pulmonary congestion	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0210911	10/24/2003	WI	39.0	39		F	10/23/2003	About 9 hours after receiving vaccine (she was feeling well at the time of vaccination).  Patient developed body aches, fever (to 101), nausea, vomiting.  Unable to keep any liquids down became dehydrated.  Hospitalized overnight 10/22-23/2003 and anticipated to send home 10/23/2003.  Improving well now. The medical records received on 1/12/04 states abdominal pain. The medical records received on 1/28/04 states headache, lightheaded and cramping in legs.				Y	Y	1			Y	10/20/2003	10/20/2003	0	Abdominal CT negative, WBC 9.4; Urine negative hormones; Na: 135; K: 4.0;Urinalysis abnormal	PUB	OTH	NONE	NONE	Mettelschmerz, renal stent secondary to stone.	nausea~Influenza (Seasonal) (no brand name)~~38.00~In Patient		1						1	Abdominal pain; Dehydration; Dizziness; Headache; Muscle spasms; Nausea; Pain; Pyrexia; Urine analysis abnormal; Vomiting	FLU3~EVANS VACCINES~765876~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0210914	10/24/2003	FL	49.0	49		F	10/16/2003	Hives. Treatment with Benadryl and Solumedrol.				Y					Y	10/06/2003	10/06/2003	0	NONE	PUB	PVT						1						1	Urticaria	FLU3~SANOFI PASTEUR~U1068AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210915	10/24/2003	VA	57.0	57		F	10/06/2003	10/16 vaccine subq RA. 10/17 painful, mild edema and erythema. 10/18 pain with itching, hot, edema, erythema (12cm x 11.5cm), Ibuprofen 800mg, Benadryl 25mg q 4d. 10/19 S/A continue Benadryl and Ibuprofen. 10/20 S/A measures 17cm x 20cm, consult with PCP, continue Benadryl, Ibuprofen, etc. If edema increases post markers, begin Prednisone.									U	10/16/2003	10/17/2003	1		PUB	UNK			Type 2 diabetes; allergy mold, dust, trees, grasses, and codeine			1						1	Injection site erythema; Injection site oedema; Injection site warmth; Pain; Pruritus	FLU3~EVANS VACCINES~765621~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0735M~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210917	10/24/2003	MS	63.0	63		F	10/16/2003	Rash on chest - Benadryl. Sore arm. Possible fever.									Y	10/14/2003	10/14/2003	0		OTH	PVT	NONE	NONE	NONE			1						1	Pain; Pyrexia; Rash	FLU3~EVANS VACCINES~765485~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0740N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210918	10/24/2003	MS	65.0	65		F		Localized swelling approximately 5 from injection site (bicep area) and to include fever in area.									N	10/07/2003	10/08/2003	1		UNK	UNK		NONE	NONE			1						1	Injection site oedema; Pyrexia	FLU3~EVANS VACCINES~765485~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0740N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210919	10/24/2003	MA	66.0	66		F	10/19/2003	Cold like symptoms started 3-4 days after the flu immunization.									U	09/30/2003	10/05/2003	5		OTH	PVT	NONE	NONE	NONE			1						1	Nasopharyngitis	FLU3~EVANS VACCINES~765485~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210920	10/24/2003	VA	12.0	12		M	10/15/2003	Painful inflammation at injection site (left deltoid), advised to take Advil and use local heat.									U	10/14/2003	10/15/2003	1		PVT	PVT	Insulin, Albuterol		Diabetes, asthma			1						1	Injection site inflammation; Pain	FLU3~SANOFI PASTEUR~U1097AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210921	10/24/2003	MA	9.0	9		M	10/17/2003	Td was administered on 10/14/03. After 24 hours the pt developed swelling from the top of the arm (deltoid area) to the area above the elbow. (Left arm induration 10cm x 8cm). The area was also erythematous.									U	10/14/2003	10/15/2003	1		PVT	PUB		NONE	Allergic to penicillin	~DTaP (no brand name)~5~4.00~In Patient		1						1	Injection site erythema; Injection site induration; Injection site oedema	FLU3~SANOFI PASTEUR~U1139AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~MASS. PUB HLTH BIOL LAB~99~UNK~IM~LA~TD ADSORBED (TDVAX)~1	USA		Influenza
0210922	10/24/2003	NY	74.0	74		F	10/15/2003	Left arm where vaccine administered became extremely painful, swollen to almost double in size. Ran temperature 101 degrees. Called 911 at 12:30 AM and ER. Spoke to nurse. Fri: left arm (blood drawn for test) became swollen and red. Being treated with antibiotics, 10 days, Cephalexin 500mg.				Y					Y	10/08/2003	10/08/2003	0		PVT	UNK		NONE				1						1	Erythema; Injection site oedema; Pain; Pyrexia	FLU3~EVANS VACCINES~765138~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1212M~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210924	10/24/2003	TX	69.0	69		F	10/23/2003	Redness, warmth, cellulitis left upper arm and swelling from elbow to shoulder. Rx: oral and IM antibiotics. As of 10/23 all symptoms in remission.				Y					Y	10/13/2003	10/14/2003	1	NONE	PUB	PVT	Neurontin, several meds for arrhythmia	NONE	Allergies, post-menopausal on hormones		SA0314	1						1	Cellulitis; Feeling hot; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1074AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0685N~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210935	10/24/2003	UT	3.0	3		F	10/23/2003	3 inch redness, swelling, and warmth started.				Y					U	10/21/2003	10/22/2003	1	NONE	PVT	PVT	NONE	NONE	Allergic sulfa			1						1	Feeling hot; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1093AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210936	10/24/2003	UT	68.0	68		F	10/23/2003	10/21 22:00:  Nausea, chills (temperature 100) achy; 10/22 afternoon: Red blotched-lower arm; 10/23 9:00:  large swollen area (size of orange), 5 inch below injection site, hot, red, itchy.  Limited mobility elbow; 10/20 PM: saw MD, started on Antibiotics, Motrin, Claritin and Codeine for pain.				Y					U	10/21/2003	10/21/2003	0	NONE	PUB	PVT	BP Meds, ASA	NONE	Hypertension	1993~Td Adsorbed (no brand name)~~58.00~In Patient		1						1	Chills; Erythema; Hypokinesia; Injection site oedema; Nausea; Pain; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~U1142AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0675M~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210937	10/24/2003	OH	31.0	31		F		Neck began itching and rash appeared.  The next morning my face was extremely swollen and also the second morning after the shot was given, the same reactions still occurring.				Y					N	10/21/2003	10/21/2003	0	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Face oedema; Pruritus	FLU3~SANOFI PASTEUR~u10734ab~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210938	10/24/2003	CA	34.0	34		F		Arm swelled and was red.  Size of orange.  Fever of 101.  Hoarseness.									Y	10/16/2003	10/17/2003	1	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Dysphonia; Erythema; Oedema; Pyrexia	FLU3~SANOFI PASTEUR~U1093AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210939	10/24/2003	NY	52.0	52		F	10/23/2003	Patient received flu and pneumonia vaccine at public clinic 10/17/2003 PM.  That PM (7-8 PM) noted itchy and redness with a raised, red, firm area 3-4 inches in diameter.  Left upper extremity around injection area.  Itching and raised firm area continued until her call to us 10/22/2003.  RN observation area 10/22/2003.  No systemic symptoms.  Patient used cool then warm compresses to area and topical benadryl for itching.									Y	10/17/2003	10/17/2003	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U1137GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~8675M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210940	10/24/2003	MN	4.5	4		M	10/23/2003	2 days post flu shot, patient developed itchiness around neck then woke up the next day with hives on his body/face.  Has had flu shot 3 times before.  Prednisone 20mg per mouth three times a day 3 days given.									Y	10/20/2003	10/22/2003	2	NONE	PVT	OTH	Benadryl PRN	NONE	Speech delay			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~u1103aa~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210957	10/24/2003	WA	55.0	55		M	10/24/2003	Flu symptoms: Vomiting 10/19/03 2:30PM - 10/19/03 8:30 PM Fever measured 10/19/03 @8:00PM about 100 Diarhhea 10/20/03 8:00 AM - 10/20/03 4:00 PM Muscle soreness & fatigue 10/19/03 2:00PM -    10/22/03									Y	10/17/2003	10/19/2003	2		PVT	UNK	Zocor 20mg.	None				1						1	Diarrhoea; Fatigue; Influenza like illness; Myalgia; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~765670~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211028	10/24/2003	FL	76.0	76		F	10/24/2003	(Approx.times)10:35am vaccinated;11:35 reported itching,welts on arms,auxilla,waist, abodmen/pelvic area;11:40Benadryl 50mg orally taken;12;05 some relief of itching;12:30 itching less,welts less red;4:11 felt better, itching confined to feet, welts lighter,repeated Benadryl 50mg.at 4:15pm and 8:00pm with 25mg at bedtime. On 10/24/03 at 10:30 reported no itching, welts almost gone. Client at no time experienced respiratory or other difficulties.									Y	10/23/2003	10/23/2003	0	none	UNK	PUB	Thyroid .88, nerve pill, name not remembered.	none given	Codeine allergy			1						1	Erythema; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1147AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211029	10/24/2003	OR	32.0	32		F	10/24/2003	whelt, red and inflammed									Y	10/22/2003	10/22/2003	0		UNK	UNK						1						1	Erythema; Injection site inflammation; Urticaria	FLU3~SANOFI PASTEUR~U1076AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1027M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211031	10/24/2003	MI	44.0	44		F	10/24/2003	50 mm erythema noted at injection site, no other S/S.									Y	10/20/2003	10/21/2003	1		PVT	PVT		n/a	n/a			1						1	Injection site erythema	FLU3~EVANS VACCINES~765798~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211032	10/24/2003	MI	55.0	55		F	10/24/2003	55 mm erythema noted at injection site, no other S/S.									Y	10/20/2003	10/21/2003	1		PVT	PVT		n/a	n/a			1						1	Injection site erythema	FLU3~EVANS VACCINES~765798~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211034	10/24/2003	LA	51.0	51		F	10/24/2003	Pt. was given the Flu vaccine at approximately 1000 and developed generalized hives and erythema at approximately 1100.  Report to the ER and received Allergia and returned to work.				Y					U	10/24/2003	10/24/2003	0	N/A	UNK	PUB		None	None			1						1	Erythema; Urticaria	FLU3~EVANS VACCINES~765670~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0211035	10/24/2003	AZ	56.0	56		F	10/24/2003	severe buring pain upon administration swelling and discomfort at site 8-12 hrs later 24-36 hrs later redness swelling and tiny white pustular lesions scattered over the red raised base- about 4.5-6 cm2 No fever chills or Lymph node involvement but did have pretty svere lowewr back pain concurrently									Y	10/16/2003	10/16/2003	0		MIL	UNK						1						1	Back pain; Discomfort; Injection site erythema; Injection site swelling; Skin ulcer; Thermal burn	FLUX~UNKNOWN MANUFACTURER~u1099AA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211036	10/24/2003	CO	66.0	65		F	10/24/2003	Patient had an excessively sore arm the day after Pneumovax injection.  She reported to an acute care clinic the following day and was diagnosed with cellulitis in the right arm. She was given IV Ancef and sent home.  Two days later, she was admitted to the hospital and given IV clindamycin followed by an oral course of clindamycin.  Her arm is improving.				Y	Y	3			Y	10/10/2003	10/11/2003	1	Discharge summary states lab test abnormal. msv	UNK	UNK	Thyroid Medication		Thyroid disorder Discharge summary states hypothyroid, diverticulitis, meniers syndrome. msv			1						1	Cellulitis; Injection site pain; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U1069AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0863N~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0211037	10/24/2003	MA	77.0	77		F	10/24/2003	Pt had been having cold symptoms x ~3 weeks prior to vaccine administration, including a persistent cough.  Received vaccine 3 days prior to admission to hospital.  1 day after administration became achy all over and cough was worse.  Denies fever.  On day of admission pt began having fainting spells and came to ER.  In ER pt was found to be in A Fib w/ RVR and had periods of asystole.  (no previous cardiac history).  Pt spontaneously converted to normal sinus rhythem.  Cardiac work-up has been negative for any cardiovascular disease and pt has been diagnosed with sick sinus syndrome and a pacemaker placed.  Pt has also received antibiotics for a pneumonia.  She has remained afebrile.  Pt has been in hospital x 5 days and remains hospitalized.  NOTE:  unknown how many times pt has previously received this vaccine - she has received it at least once previously in 2002. Nurse follow up on 06/28/04 states:  ADD: tachycardia, atrial fibr, hypokalemia, infiltrate, Upper GI bleed, sick sinus syndrome.					Y	5			Y	10/16/2003	10/19/2003	3	IN ED on 10/19: K+ = 3.1.  EKG= A.fib w/ RVR and occasional asystole.  CXR = Left lower lobe infiltrates.  10/20:  PT in normal sinus rhythem.  Echo: normal.  K+ 3.8.	PVT	UNK	Requip 25mg/day divided in 3 doses; Sinemet 25/100 every 3 hours; Klonopin 0.5mg 1/2 tab bid; Motrin prn	Cold x 3-4 weeks	1. Parkinsons Disease 2. History of hypertension after previous hospitalization approx 1 year ago - however pt reports BP has been normal and pt has not been taking Cardizem CD 180mg q day as previously prescribed. 3.  Macrolide allergy 4. Gastric Ulcer 5. Cardiomegaly 6. CHF			1						1	Atrial fibrillation; Cough; Gastrointestinal haemorrhage; Hypokalaemia; Laboratory test abnormal; Lung disorder; Pain; Sinus bradycardia; Syncope; Tachycardia	FLUX~UNKNOWN MANUFACTURER~765853~2~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0211038	10/24/2003	FL	69.0	69		M	10/24/2003	Hives in left foot, around the toes.  Received shot at 9:30 AM reaction at 3:30 PM.									Y	10/24/2003	10/24/2003	0		PVT	UNK	None	None	None			1						1	Urticaria	FLU3~EVANS VACCINES~765874~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211039	10/24/2003	WA	47.0	47		F	10/24/2003	Immediate swelling and itching of the injection site. Area of erythema approximately 3 inches in diameter.  Tachycardia to 120 bpm. Ice applied. Swelling and itching subsided by the next morning (20 hours later).   Area of induration still palpable 44 hours later.									Y	10/21/2003	10/21/2003	0		PUB	PUB			pollen			1						1	Injection site hypersensitivity; Injection site induration; Injection site swelling; Pruritus; Tachycardia	FLU3~EVANS VACCINES~765670~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211040	10/24/2003	WA	47.0	37		F	10/24/2003	Some soreness at injection site the evening after the injection. 20 hours later noted itching and selling at the site. 44 hours later stated that all symptoms had resolved									Y	10/22/2003	10/23/2003	1		PUB	PUB			Hayfever			1						1	Injection site hypersensitivity; Injection site pain; Injection site swelling; Pruritus	FLU3~EVANS VACCINES~765670~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211041	10/25/2003	AZ	26.0	26		F	10/25/2003	I developed a 3 inch raised red welt around the injection site within 12 hours of receiving the vaccine. The entire upper arm was tender and hot to the touch. Hot flashes, chills, and upset stomach followed.				Y					U	10/22/2003	10/23/2003	1	None.	PVT	UNK	Atarax, Prednisone		Allergic rhinitis			1						1	Chills; Hot flush; Injection site pain; Injection site swelling; Injection site warmth; Stomach discomfort; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0210967	10/27/2003	NM	52.0	52		F	10/16/2003	Day of shot right arm had soreness.  Next day golf ball size welt on right arm.  20 day swelling went down but very large hot red area.  Some fever since shot.  Axillary lymph adenopathy.				Y					Y	10/14/2003	10/14/2003	0	NONE	MIL	MIL	Inderal	NONE	Coronary Artery Disease			1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth; Lymphadenopathy; Pyrexia; Urticaria	FLU3~EVANS VACCINES~765754~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1027M~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210968	10/27/2003	KY	48.0	48		F	10/15/2003	Swelling, tenderness, red induration around injection site with aching.									Y	10/14/2003	10/15/2003	1	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site pain; Pain	FLU3~EVANS VACCINES~765497~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0287N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210969	10/27/2003	KY	32.0	32		F	10/15/2003	Complained of swelling, warmth, pain in left arm from shoulder to elbow complained of generalized aching in arm.									Y	10/14/2003	10/14/2003	0	NONE	OTH	PVT	NONE	NONE	Codiene			1						1	Feeling hot; Injection site oedema; Injection site pain; Pain	FLU3~EVANS VACCINES~765497~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0287N~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210970	10/27/2003	KY	52.0	52		F	10/15/2003	Redness, warmth at injection site.  Pain under left arm very tender in axillary area.  10/16/2003: Developed whelps from deltoid radiates under arm.									Y	10/15/2003	10/16/2003	1	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Feeling hot; Injection site erythema; Injection site pain	FLU3~EVANS VACCINES~765497~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0287N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210971	10/27/2003	KY	43.0	43		F	10/15/2003	Complained of arm swelling from shoulder to elbow red, tender to touch.  Pain in arm joint and muscle pain body pain for 2 days.									Y	10/08/2003	10/09/2003	1	NONE	OTH	PVT	Ternormin, Tegental, Premarin, Accupine	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site pain; Myalgia	FLU3~EVANS VACCINES~765497~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0287N~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210972	10/27/2003	VA	47.0	47		F	10/24/2003	Patient reports noticing a rash that encircles the area of the left arm where the vaccine was given.									U	10/20/2003	10/23/2003	3	Physical exam per MD/Physicians assistant	OTH	PVT	Combivent, Advair, Calcium, Albuterol, Singulair, Vicatin	NONE	Low back pain, Recurrent adult asthma			1						1	Rash	FLU3~SANOFI PASTEUR~U1124AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210973	10/27/2003	MN	24.0	24		F	10/24/2003	Flu shot given 10:30.  Ate lunch and took 500mg zithromycin at 11:30.  Within 20 minutes now lightheadness, nausea, shortness of breath, tachycardia.									U	10/24/2003	10/24/2003	0	NONE	PVT	PVT	BCP	NONE	Bronchitis-very mild			1						1	Dizziness; Dyspnoea; Nausea; Tachycardia	FLU3~EVANS VACCINES~u765955~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210974	10/27/2003	CT	55.0	55		F	10/24/2003	Patient was administered vaccine into left deltoid.  Patient had vaccine previously without incident.  Patient had left deltoid and tricep pain that profounding worsened.  Pain wakes patient from sleep.									N	10/10/2003	10/11/2003	1	Diagnosis ultrasound	OTH	PVT	NONE	NONE	NONE			1						1	Pain	FLU3~SANOFI PASTEUR~U1270AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210975	10/27/2003	DC	58.0	58		M	10/22/2003	Patient received flu shot in left deltoid on 10/10.  Patient developed pain and swelling in her right deltoid for 3 days.  Tenderness in the left thigh.  Patient noticed 2cm blister on left deltoid. Discomfort in left buttock and left thigh.  On patient, the blister is noticeably swollen and some ? with 2cm blister. Pt received flu shot in left deltoid 10/20/03. Developed pain and swelling in left buttock, 36 hrs later. Pt noted weakness and tenderness in left thigh. 2cm blister on left buttock noted 10/22/03. Currently resolving. On exam swollen left buttock, tender, 2cm overlying blister treated by pt's PMP. Dx zoster. Rx ? not known.									U	10/20/2003	10/21/2003	1	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Blister; Herpes zoster; Injection site oedema; Muscular weakness; Pain; Tenderness	FLU3~SANOFI PASTEUR~U1271AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210977	10/27/2003	IA		61		M	10/24/2003	Received flu shot Tuesday-on Wednesday AM developed hives, type rash on legs, waist arm and red and itchy.									U	10/21/2003	10/22/2003	1	NONE	OTH	PVT	Lipitor, Omeprazole	NONE	NONE			1						1	Injection site erythema; Rash pruritic; Urticaria	FLU3~SANOFI PASTEUR~U1087AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210978	10/27/2003	FL				U		Employee health nurse administering flu vaccine.  Had multiple complaints of burning soreness/swelling/ heat from site.									Y				NONE	PUB	PVT	NONE	NONE	NONE			1						1	Injection site pain; Injection site warmth; Skin burning sensation	FLU3~SANOFI PASTEUR~U1127AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210979	10/27/2003	OK	92.0	92		F	10/01/2003	Patient with pain in arm night of vaccination, red was and pain at 24 hours.  Cellulitis changes below area of vaccine at 48 hours.  Both shots + b12 gone in sauce left deltoid region.  Prescription with Cefobid 300 three times per day.				Y					Y	10/20/2003	10/22/2003	2	NONE	PVT	PVT	NONE	NONE	NONE (history of biz defficiency)			1						1	Cellulitis; Erythema; Pain	FLU3~EVANS VACCINES~765703~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0676M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210980	10/27/2003	OR	55.0	55		F	10/23/2003	Had flu shot and approximately 45 minutes later mouth, tongue and throat feels numb able to swallow ok.									Y	10/23/2003			NONE	PUB	PVT	NONE	NONE	Tetracycline			1						1	Hypoaesthesia	FLU3~EVANS VACCINES~765796~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210981	10/27/2003	ME	52.0	52		M	10/24/2003	Patient noted that his left arm was very sore and achy the day after receiving the shot.  He came to the office today and stated he's experienced a rash all over his body and extreme itchiness the day after the shot was administered.  He has a few itchy lesions left 3 days after administration.									Y	10/21/2003	10/22/2003	1	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Injection site pain; Pain; Rash; Rash pruritic; Skin ulcer	FLU3~SANOFI PASTEUR~U1097AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210982	10/27/2003	GA	37.0	38		F	10/23/2003	Rash on chest, neck, under breast.  Dryness around legs and face.  Also had fever 72 hours after injection.  Rash increased over last few days, not getting better.									U	10/15/2003	10/18/2003	3	NONE	PUB	OTH	NONE	NONE	NONE			1						1	Dry skin; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U1081AA~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210983	10/27/2003	TN	70.0	70		F	10/18/2003	10/10/2003: Right arm -got red, extremely swollen, hot and hurting.  Kept getting bigger and redder.  Went to ER and they gave her Zyrtec 10mg and told her to pack in ice.  Blood pressure increased and patient instructed to take additional bp pill.  Totally resolved by 10/16/2003.				Y					Y	10/10/2003	10/10/2003	0	NONE	OTH	PUB	NONE	NONE	NONE			1						1	Blood pressure increased; Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U1095AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0772N~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210984	10/27/2003	MN	20.0	20		F	10/21/2003	At injection site a welt with red line going up pt arm. Pt starting vomiting and running low grade fever.									Y	10/17/2003	10/18/2003	1		PVT	UNK						1						1	Cellulitis; Pyrexia; Urticaria; Vomiting	FLU3~SANOFI PASTEUR~U1137FA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210985	10/27/2003	PA	61.0	61		F	10/20/2003	10/17/03: 48 hours later started with itching and hives lower abdomen, thighs, back. 10/18/03: legs, mid back-hives. 10/19/03: palms of hands red, back of neck and arms-hives. 10/20/03: abdomen, back-hives. Back of legs and thighs-hives. Still taking Benadryl.									U	10/15/2003	10/17/2003	2	NONE	PVT	PVT	Lipitor	NONE	High cholesterol			1						1	Pruritus; Urticaria	FLU3~EVANS VACCINES~765670~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210986	10/27/2003	PA	20.0	20		F	10/19/2003	(?) red itchy papules on arms, anterior abdomen and chest and legs less than 24 hours after vaccine.									U	10/16/2003	10/17/2003	1	NONE	OTH	UNK		NONE	Allergies to cats, dogs, peanuts			1						1	Erythema; Pruritus; Rash papular	FLU3~SANOFI PASTEUR~U1131AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210987	10/27/2003	CO	76.0	76		F	10/16/2003	Right arm swelled from armpit to elbow. Although injection was on deltoid, redness and swelling was on inner arm. Pt showed arm 2 days after pneumo injection. 1st 24 hours was very red and swollen, 2nd 24 hours was pain radiating from elbow down to hand. Dark redness and swelling still occurred 48 hours later. Pt went to ER 10/12/03. By 10/13, swelling down, redness turned to yellow. Left arm pneumococcal site problem.				Y					Y	10/11/2003	10/11/2003	0		OTH	OTH		NONE				1						1	Erythema; Oedema; Pain	FLU3~SANOFI PASTEUR~U1069AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0863N~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210988	10/27/2003	FL	74.0	74		F	10/20/2003	Pneumo injection site right deltoid on 10/15/03. Bruising 4 cm circle next day, then swelling at site, down arm to midforearm erythema extending 15 down arm, hot to touch. Also swelling into right shoulder and neck. Solemedrol 125mg IM on 10/17/03, Sx decreased in about 1 hour and resolved by 10/19/03.									Y	10/15/2003	10/16/2003	1	NONE	PVT	OTH	Premarin, ACTZ, Synthroid, Persantine, Fosamax, Vasotec, Arthrotec, Lipitor	NONE	Diverticulitis, HTN, hypothroidism, high cholesterol, angina, anxiety, osteoporosis. Allergies to sulfa, Flaxavin, Darvocet, Macrodantin			1						1	Contusion; Injection site erythema; Injection site oedema; Injection site warmth	FLU3~EVANS VACCINES~765854~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0531N~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0210989	10/27/2003	CA	31.0	31		F	10/23/2003	Pt received the pneumovax vaccine in her right deltoid on 10/21/03 which resulted in an allergic reaction of a red, raised area of 55 x 50mm, circular formation. Pt c/o hotness and pain to red area.									U	10/21/2003	10/23/2003	2		PUB	OTH	PPD Aventis C1259AA right forearm		NONE			1						1	Hypersensitivity; Injection site warmth; Pain; Rash erythematous	FLU3~EVANS VACCINES~765145~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~NE980~1~~RA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U1011AA~1~~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0210990	10/27/2003	NV	31.0	31		F	10/16/2003	1 hour after injection started itching at vaccination site, cheeks became bright red and by morning had mosquito type bumps face, arms, legs.									Y	10/14/2003	10/14/2003	0	NONE	PUB	PVT	Flagyl	NONE	NONE			1						1	Erythema; Pruritus; Rash	FLU3~EVANS VACCINES~765499~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0210991	10/27/2003	GA	10.0	10		M	10/20/2003	Local swelling and redness from shoulder to elbow. Treated with Benadryl, resolved.									Y	10/17/2003	10/18/2003	1	NONE	PUB	PUB	Albuterol inhaler, Advair, Zyrtec, Singulair	NONE	Asthma			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1127AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210992	10/27/2003	NC	83.0			M	10/16/2003	Long term care pt received vaccination on 10/14/03. On 10/15/03, he developed nausea/vomiting and complained of a general poor feeling.									U	10/14/2003	10/15/2003	1	10/15/03: BUN 62 mg/dL, Cr 2.8 mg/dL -Chronic renal insufficiency. H&H 11.1 g/dL, 33.8% - chronic anemia - WBC 14.4 K/cmm	UNK	UNK	NONE		NKDA Nonsmoker, non alcohol user. Chronic renal insufficiency, chronic anemia, HTN, PVD, DM-Type II.			1						1	Malaise; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U1268AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210993	10/27/2003	WI	36.0	36		F	10/17/2003	Pt presents ambulatory post influenza vaccine 30-35 minutes. C/o numbness right upper extremity and tingling right wrist. Shot administered in right upper arm. Pt provided Ketorolac 10mg po for pain.									U	10/15/2003	10/15/2003	0		UNK	UNK	NONE					1						1	Hypoaesthesia; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U1144AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0210994	10/27/2003	OR	25.0	25		F	10/19/2003	After flu shot she waited 15 minutes and said she felt fine but by the time she got home her throat felt constricted. She called. I told her to call 911. She didn't want to and came here. I game 2 Epipens #7 10 minutes apart, I called 911, fire crew and ambulance arrived, they took vitals and told her she should go to ER. She signed a waiver that she didn't want (unreadable). She drove herself to (unreadable)...She then told me she was feeling awful when she left but wanted to leave, not sure if from shot.									Y	10/18/2003	10/18/2003	0		OTH	PVT		NONE	Asthma			1						1	Malaise; Throat tightness	FLU3~SANOFI PASTEUR~U1069AD~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211000	10/27/2003	CA	49.0	49		M	10/20/2003	Swollen glands - posterior cervical. Diffuse macular papular rash. Diarrhea x2 days.				Y					U	10/07/2003	10/18/2003	11	NONE	PVT	PVT		NONE	Hypertension, allergy to PCN			1						1	Diarrhoea; Lymphadenopathy; Rash maculo-papular	FLU3~EVANS VACCINES~765668~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~265A6~2~IM~~HEP A + HEP B (TWINRIX)~1|MMR~MERCK & CO. INC.~0180M~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0211066	10/27/2003	UT	68.0	68		M	10/27/2003	Moderate hives on sole of foot,(with severe itching) palm of hand, underarms.  Never experienced any allergic reactions from previous (20 years) flu vacines.									Y	10/20/2003	10/21/2003	1		UNK	UNK						1						2	Chest pain; Hypertension; Pruritus; Rash; Urticaria; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0211135	10/27/2003	LA	46.0	46		M	10/27/2003	Dizziness, Lightheaded, generalized weakness									Y	10/23/2003	10/23/2003	0	Blood pressure monitoring--106/82mmHg Pulse: 90bpm RR:  20 bpm Sat: 99% room air	PUB	PUB	None	No	No			1						1	Asthenia; Dizziness	FLU3~SANOFI PASTEUR~U1128AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211137	10/27/2003	VA	21.0	21		M	10/27/2003	stating adverse event to influenza vaccination. Right Deltoid area at injection site, red, warm, swollen and painful to the touch (5/10) and while at rest (2/10). Patient concerned that this is an adverse reaction to influenza vaccination. He has had 3 previous vaccinations with influenza without adverse event.									Y	10/22/2003	10/23/2003	1	None	MIL	MIL	HCTZ, Norvasc	Hypertension	PCN, E-mycin, Tetracycline			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~4~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211138	10/27/2003	TX	41.0	41		F	10/27/2003	numbness of tongue, lip swelling, itching around eyes, chest heaviness, tacchycardia c rrr@100bpm				Y					Y	10/24/2003	10/24/2003	0		UNK	UNK						1						1	Chest pain; Eye irritation; Face oedema; Hypoaesthesia; Tachycardia	FLU3~SANOFI PASTEUR~U1099~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0604N~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211140	10/27/2003	WI	9.0	9		F	10/27/2003	REDNESS AT SITE, FEVER OF 101 NEXT DAY.  MUSCLE ACHES. Follow up on 11/17/2003: Both vaccinations given in same arm; unable to determine which caused reaction.									Y	10/09/2003	10/10/2003	1	none	PUB	PUB						1						1	Injection site erythema; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~u1145aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~4915777~UNK~IM~LA~PNEUMO (PREVNAR)~1	USA		Influenza
0211142	10/27/2003	FL	60.0	60		F	10/27/2003	Patient experienced severe headache along with facial numbness on her left side									Y	10/21/2003	10/21/2003	0	Possible Belles Palsy	PVT	UNK						1						1	Facial palsy; Headache; Hypoaesthesia	FLU3~EVANS VACCINES~765874~3~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211143	10/27/2003	IA	35.0	35		F	10/27/2003	Had a temperature of about 103, shaking, very achey and hard to walk and my arm hurt where I received the shot.  Took one dose of Vicks cold/flu tablets (2) and took Tylenol (1 - 650 mg.) the next day.  Recovered in about a day and a half.									Y	10/24/2003	10/25/2003	1		UNK	PVT	Ortho-Tricyclen Lexapro - 10mg.	None that I know of.	Hayfever			1						1	Difficulty in walking; Pain; Pyrexia; Tremor	FLU3~EVANS VACCINES~765501~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211144	10/27/2003	WI	68.0	65		F	10/27/2003	Small rash developed on left arm two days after receiving vaccine.  The next day the rash was 5 inches in diameter and hot to the touch.  Patient saw doctor and was prescribed cephalexin 500mg BID for ten days.  Rash cleared by end of treatment.				Y					Y	10/14/2003	10/16/2003	2		UNK	PVT		None	Hypertension, hyperlipidemia, depression			1						1	Feeling hot; Rash	FLU3~SANOFI PASTEUR~u1047AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0710m~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211145	10/27/2003	MN	22.0	22		F	10/27/2003	Influenza vaccine given at 0900, employee reported history of anxiety with shots.  Sat for 2 minutes after shot, reported feeling fine.  After walking back to the unit, employee reported feeling dizzy, weak and lightheaded for about one and a half hours.  BP was 70/? when checked. Employee does not remember diastolic.  Employee reports symptoms resolved spontaneously and at 12:30pm when speaking with employee to f/u no symptoms noted at all.									Y	10/27/2003	10/27/2003	0	None	PVT	PVT						1						1	Asthenia; Blood pressure decreased; Dizziness	FLU3~EVANS VACCINES~765502~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211146	10/27/2003	NY	80.0	80		F	10/27/2003	Within 10 minutes of vaccination, pt. experienced facial flushing and swelling that was observed by self and others. Right arm tender, very swollen, bruised.  Friday night face felt hot, swollen.Did not sleep well that night; felt hot, aching all over. Symptoms of feeling hot, swollen continued all weekend. States she thought she must be runny a fever but upon checking found it to be 98.2.Made appt to see MD on Monday 10/27 and was told she had hives over face, chest, back, most likely due to influenza shot. MD recommended benadryl 25 mg STAT and then q 4-6 hrs. until rash resolves. Pt has had numerous flu shots in the past without problem.				Y					Y	10/24/2003	10/24/2003	0	None	UNK	PVT	Monopril (suspended for one week due to hives) HCTZ Levoxyl ASA 1 qd Celebrex	Arthritis (diagnosis not yet confirmed) Hypertension	Amoxicillin			1						1	Contusion; Feeling hot; Flushing; Injection site pain; Pain; Swelling; Urticaria	FLU3~EVANS VACCINES~765621~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0210879	10/28/2003	OH	50.0	50		M		From initial info received on 10/15/2003 from a pharmacist, regarding an adverse event occurring in the USA, it was reported that a 50-year-old male pt received Fluzone SV '2003-'2004 USP, lot number U1268AA (route and site not reported) at 8:44 AM on 10/14/2003. At 2:30 PM, the pt experienced shortness of breath, cough and feeling heaviness in his chest. The pt called the clinic nurse one hour after experiencing these symptoms and he was advised to call 911. The reporting pharmacist spoke with the pt the following day (10/15/2003) and the pt stated that he did not call 911, but took a hot shower and used Vicks. The pt stated that he now feels fine. The pt's recovery status was not reported. The pt had slight wheezing and allergic rhinitis prior to injection. From additional info received on 10/16/2003, from the reporting pharmacist, it was reported that the pt was seen in the clinic on 10/14/2003 for complaints of pain in his right ear, ear infection and a cough. The pt was diagnosed with a sinus infection and possible asthmatic bronchitis. He was prescribed Bacrim DS twice a day, albuterol inhaler two puffs twice a day and Actifed one tablet twice a day. It was recommended that he attend smoking cessation classes as well. At the time of his visit, the pt received the influenza vaccine and there is no documentation that the pt had ever received one in the past. Reportedly, the pt does not have any known food or drug allergies. The pt did not go to the ER after experiencing the reported adverse events and stated that the events resolved after he took a shower and used Vicks. The reporter stated that the pt's recovery status is recovered. 10/17/2003: During internal review of this file, it was noted that the Required emergency room/doctor visit box was inadvertently clicked. Per the source documentation for this case, it was noted that the pt was not seen in an ER or by a physician for the adverse events he experienced on 10/14/2003. A new version of this case was created for the purpose of correcting this error.									Y	10/14/2003	10/14/2003	0	From follow-up 10/16/2003: No lab work or diagnostic tests were performed.	MIL	UNK		Pt had slight wheezing and allergic rhinitis prior to injection. The pt was seen in the VA clinic at the time of vaccination for complaints of right ear pain and cough. He was diagnosed with a sinus infection and possible asthmatic bronchitis.	Pt has a history of allergic rhinitis. The pt does not have any known food or drug allergies. The pt has a history of tobacco use, headaches and erectile dysfunction. He has an occasional cough and experiences occasional wheezing, mostly at night. It is not known whether this pt had ever had a previous influenza vaccine.		200302381	1						2	Chest pain; Cough; Dyspnoea; Chest pain; Cough; Dyspnoea	FLU3~SANOFI PASTEUR~U1268AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1268AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0211044	10/28/2003	CA	79.0	79		F	10/23/2003	From initial info received on 10/22/03, from a health care professional, regarding a death occurring, it was reported that a 79 year old female pt died of a heart attack on 10/19/03, two days after receiving a dose of Fluzone SV '2003-'2004, lot number U1260AA, given IM in the left deltoid on 10/17/03. The reporter stated that the case of death indicated on the death certificate was cardiac arrest. A 15-day follow up report received 11/04/2003 adds: From additional info obtained on 10/27/2003, from a telephone conversation with the reporter, it was stated that the responsible physician is waiting for follow-up documents. The reporter also stated that she was not sure if there will be an autopsy report and that they had not yet received any hospital records or test results. The correct spelling of the responsible physician's last name was also provided. A 15-day follow up report received 11/13/2003 adds: From additional info received on 11/06/2003 from faxed correspondence from the reporter, it was reported that the pt had pre-existing conditions of hypertension, hyperlipidemia, osteoarthritis, spinal stenosis, acromegaly and Parkinson's disease. The pt received the influenza vaccine on 10/17/2003 and expired on 10/19/2003 at 9:31 AM. Per the reporter, the pt's death was not caused by the vaccine. The death certificate was also provided and the immediate cause of death was listed as cardiac arrest . Both hypertension and hyperlipidemia were listed as underlying cause. No other info was reported. Case is closed.	Y	10/19/2003							N	10/17/2003	10/19/2003	2		PVT	PVT			Hypertension, hyperlipidemia, osteoarthritis, spinal stenosis, acromegaly and Parkinson's disease		200302675	1						1	Myocardial infarction	FLU3~SANOFI PASTEUR~U1260AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0211046	10/28/2003	AZ	83.0	82		M		This is a 83 year old male who died on August 21, 2003 while enrolled in RSV S and I study with RSV vaccine. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/21/02. The subject died 304 days post immunization while in hospice care. The event was reported by the investigator as not related to the study vaccine. A 15-day follow up report received 10/31/2003 adds: The subject died 305 (corrected) days post immunization while in hospice care. Additional info received 10/24/2003: Date of death is 08/22/2003, changed from 08/21/2003. Diagnosis: Pt died at hospice on 08/22/2003 from CHF and ESRD.	Y	08/22/2003							N	10/21/2002	08/21/2003	304		UNK	UNK	RSV/Placebo, Celexa, Aspirin, Prevacid, Nephrocap, Amiodarone, Coreg, Metoclopramide, Miralax, Alphagan, Lumigan, Flonase		Information received October 17, 2003 regarding previous hospitalizations: Discharge Summary: 5/29/03-6/4-03. The subject developed respiratory distress and wheezing 220 days post immunization and was admitted to the hospital on 5/29/03. He was diagnosed with possible pneumonia or bronchitis along with reactive airways disease and also volume overload state. The pt received dialysis with fluid removal as tolerated. he was hypotensive on dialysis and received dialysis several days in a row. The pt was treated with IV antibiotics along with oral Biaxin and has been maintained on oral Biaxin. Also, the pt has received supplemental oxygen and small volume nebulizer bronchodilator therapy. His respiration status has improved significantly throughout the hospitalization. Repeat chest x-ray showed interval decreases in the bilateral perihilar opacities, with a small pleural effusion. Dialysis will be continued 3 times a week. Subject's condition is ongoing and he was discharged from hospital to a nursing facility 7 days later on 4/6/03. The event was reported by the investigator as not related to the study vaccine. Admission/ Discharge Summary 7/22/03-7/25/03. The subject developed increased shortness of breath over the last five days and was admitted 274 post immunization on 7/22/03 with SOB, CHF, fluid overload and pleural effusion. Treatment underwent a thoracenteses of the right pleural effision. The fluid studies were consistent with a transudative effusion likely secondary to fluid overload with this end-stage renal disease and congestive heart failure. He continued on hemodialysis during the hospital course and his fluid status improved as well as his respiratory status. After undergoing hemodialysis the pt experienced some episodes of hypotension but remained asymptomatic without any chest pain, shortness of breath, lightheadedness or dizziness. He was started on Proamatine 2.5mg po bid to be increased as needed. Pt also experienced some diarrhea. A c. diff stool study done on the 6/25/03 was noted to be positive for C. diff. He was started on Flagyl 500mg po tid for 10 days. Pt was discharged to a nursing home 3 days later on July 25. He was comfortable at rest and ambulated with oxygen 2 liters nasal cannula. The pt will continue on hemodialysis on a three times a week basis and will continue on his medications including Coreg and Amiodarone. Labs include a white count of 10.3, hemoglobin of 11.7, platelets of 230,000, sodium 136, potassium 3.9, chloride 98, bicarb 28, BUN 43, creatinine 4.5, glucose 123, calcium 8.9, total bilirubin 1, AST 37, ALT 47, Alk phos 135, CK 34, Troponin 0.07, chest x-ray shows a right-side pleural effusion as well as bilateral perihilar consistent with CHF. The EKG shows sinus rhythm with ST depression findings in the lateral leads and inferior leads. C. diff stool study done on the 6/25/03 was noted to be positive for C. diff. The event was reported by the investigator as not related to the study vaccine. Admission/ discharge 8/4/03. Hx-CHF, pneumonia, pleurisy, pleural effusion, RAD, ESRD, prostate surgery, quit smoking 20 years ago. The subject developed SOB and a productive cough 287 days post immunization and was admitted to the hospital on 8/4/03. Pt apparently had been having similar problems which had cleared up after a course of treatment, however symptoms resumed over the next couple of days. Treatment included oxygen, SVN and IV antibiotics and he was placed on IV Invanz. Chest x-ray revealed diffuse infiltrates and bilateral pleural effusions. Cocci serology report is pending. CPK 27l, sodium 136, potassium 4.5, chloride 99, CO2 29, glucose 137, BUN 23, creatinine 4.4, SGOT 83, SGPT 124, alkaline phosphatase 208, Troponin negative, white count 7.5, hemoglobin 12.3, platelets 531. No manual differential available. EKG shows sinus rhythm without any acute ischemic changes. The subject's condition is ongoing and he was discharged the same day. The event was reported by the investigator as not related to the study vaccine. Admission/ Discharge 8/11-8/15-03. The subject developed SOB 294 days post immunization and was admitted to the hospital on 8/11/03 with chronic obstructive pulmonary disease exacerbation. He was started on Solu-Medrol 120mg IV, then 60mg IV q. 12H, SVN. Treatments of Albuterol and Atrovent were started q. 4h. while awake. Pulmonary consultation was arranged. He was started on his home medication as well as Flagyl 500mg one po tid x 5 days which had been started prior to admission. He was seen in consultation and assessment was respiratory insufficiency, mental status change, right pleural effusion and COPD. At this point his medications were continued as previously ordered. He was seen by a Nephrologist for continued dialysis. On the 13th he remained stable. Speech evaluation is ordered for evaluation of his swallowing. CT scan of his chest was noted to show possible right upper lobe mass. CT scan of head show atrophy, with nothing acute. At this point there are no further plans for further evaluation of the mass. On the 15th Dr. did discuss the mass at length with the family and they decided on a hospice evaluation. The subject's condition is ongoing and he was discharged with hospice to the nursing home 4 days later on 8/15/03 to hospice. Lab: sodium 138, potassium 5.0, chloride 101, CO2 30, glucose 147, BUN 27, creatinine 4.8, albumin 2.5, alkaline phosphatase 125, white count 6.6, hemoglobin 11.6, platelet count 362,000, blood gases 7.46/43/76 four liters. The event was reported by the investigator as unrelated to the study vaccine.		200302461	1						1	Cardiac failure congestive; Renal failure acute	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0211053	10/28/2003	IN	69.0	68		M	10/21/2003	Information has been received from a pharmacist and a RN concerning a 68 year old male with no known allergies who during a vaccination clinic at a pharmacy on 10/5/03 between 1400 and 1500 was vaccinated IM in the right arm with a dose of pneumococcal 23v polysaccharide vaccine (644219/1079M). On 10/8/03 the pt was also vaccinated in the left arm with a dose of influenza virus split virion 3v vaccine inactivated (Fluzone). Concomitant therapy included Flovent and Serevent. The pt's wife reported to the pharmacist that on 10/8/03, about 6 hrs after administration, the pt developed a lump at the site of injection in the right arm. It continued to get worse and worse. On the morning of 10/9/03 the pt went to the ER because the arm had become so swollen and painful and he was unable to move it. A venous ultrasound revealed a hematoma at the injection site. The pt was diagnosed with cellulitis and treated with Rocephin and Keflex. On the afternoon of 10/9/03 the pt was seen by his primary care physician and started on Keflex, Vicodin, and ibuprofen. As of 10/10/03, the pt was doing better. It was also reported that the wife had indicated that her husband developed a 'bad reaction in the arm to the pneumococcal 23v polysaccharide vaccine because the product was contaminated. On 10/10/03 the pt's wife called the pharmacist to obtain the lot number for the pneumococcal 23v polysaccharide vaccine and that the pt was going for a second visit to his PCP. On 10/11/03 the pt was again seen in the physician's office and was considered to be much improved. It was also reported that this pt lives about an hour away from the pharmacy and is not a regular customer of this pharmacy. A product quality complaint is involved. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards and was released. Upon internal review, cellulitis and hematoma at the injection site were determined to be other important medical event (OMIC). Additional info has been requested.  Follow up on 11/26/2003: No futher information is expected.				Y					Y	10/08/2003	10/08/2003	0	Venous ultrasound-hematoma at injection site 10/9/03	OTH	OTH	Flovent, Serevent		UNK		WAES0310USA01491	1						1	Cellulitis; Haematoma; Hypokinesia; Injection site haemorrhage; Injection site mass; Pain	FLU3~SANOFI PASTEUR~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1079M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211058	10/28/2003	WA	50.0	50		M	10/23/2003	Pt apparently had his first shot for influenza at Dr's office on 10/14/03 in the morning at 11 am up to 12 noon. That evening of 10/14/03 had sore throat. Became more ill upon awakening on 10/15/03 Wednesday. Sore throat, cough and fever, ached all over, not eating, intense headache. Did attempt to go to work but felt worse and went home at 3:30pm. Shaky, uncontrolled chills, and his temp was 103. Cough somewhat productive, not colored. He tried taking ibuprofen and Day Quil but his fever progressed up to 105. Admitted to hospital on 10/16/03-indication: chills, fever, pneumonia, cough and congestion, headache, muscular aches and pains. X-ray indicated no radiographic evidence of acute cardiopulmonary disease. Pt was hospitalized until 10/19/03. Discharge 10/19/03 with instructions to follow up with his physician in 7-10 days. Wellbutrin 150mg take twice a day. Continue any other home meds.				Y	Y	3			Y	10/14/2003	10/14/2003	0	Blood culture-no growth 1 day, 2 days. Respiratory culture: specimen description-sputum. Gram stain-moderate gram positive cocci rare gram positive rods, few gram negative rods, rare epithelial cells, few WBC's seen, group 5.	PVT	PVT			PCN, sulfa, pneumonia in the past, hypertension, hypercholesterolemia, bronchitis			1						1	Anorexia; Chills; Cough; Headache; Laboratory test abnormal; Lung disorder; Myalgia; Nasal congestion; Pain; Pharyngolaryngeal pain; Pneumonia; Pyrexia	FLU3~EVANS VACCINES~765667~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0211060	10/28/2003	IL	58.0	58		F	10/27/2003	10/25/2003 @ 20:00: Chills, body aches; 10/26/2003 @ 11:00: Hives (palms of hands, torso, thighs)									Y	10/25/2003	10/25/2003	0	NONE	PUB	PUB	NONE	NONE	Treatment for Cancer-Remedex			1						1	Chills; Pain; Urticaria	FLU3~EVANS VACCINES~765854~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0664N~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211061	10/28/2003	IA		78		M	10/27/2003	Blazing case of hives.  Treated with cortisone and antihistamines.				Y					U	10/20/2003	10/23/2003	3	NONE	OTH	OTH	UNK	UNK	UNK			1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0211062	10/28/2003	GA	46.0	46		F	10/16/2003	Client developed pain and swelling five hours after receiving Pneumonia vaccine in the left shoulder and arm.  Shoulder is warm to touch.									U	10/15/2003	10/15/2003	0	NONE	PUB	PUB	Prozac, Estertase, Beetra	NONE	Codeine, Morphine, Fibromyalgia		GA03104	1						1	Feeling hot; Hypoxia; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U1089AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~0872N~1~IM~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0211063	10/28/2003	MO	88.0	88		F	10/15/2003	Twenty minutes after flu shot given patient returned complaining of severe headache, sick to her stomach, hot and clammy.  Patient taken to ER.				Y					U	10/15/2003	10/15/2003	0	Both nurses felt this was not flu shot related.  It was more like a heart attack.  Ambulance people said the same.	PUB	PVT	NONE	NONE	NONE			1						1	Cold sweat; Headache; Hot flush; Nausea	FLU3~EVANS VACCINES~765176~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0211064	10/28/2003	WA	56.0	56		F	10/27/2003	Localized urticaria noted right upper arm. The follow up received on 11/17/03 states onset redness.									Y	10/23/2003	10/24/2003	1	NONE	PUB	OTH	ASA, Thyroid, BP meds, and diabetic med	NONE	Hypertension, Cholethyroid CA'87, Diabetes Mellitus			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1132AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211065	10/28/2003	PA	75.0	76		M	10/27/2003	Right arm swelling at site reported to be pneumovax.									U	10/21/2003	10/23/2003	2	NONE	OTH	OTH	Levoxyl 0.075	NONE	Emycon			1						1	Injection site oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0211066	10/28/2003	UT		68		M		Rash/hives on palms and soles, intensive itching peaked 3-4 days after vaccination, high blood pressure (155/90) for 4 days and chest pain (never had before).									U	10/20/2003	10/21/2003	1	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Chest pain; Hypertension; Pruritus; Rash; Urticaria; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0211067	10/28/2003	CT	35.0	35		F	10/24/2003	Headache, erythema, wheal 6cm x 4.5 cm.  Warm to touch, patient applied hand to region.  Patient went to ER and was given antibiotics for the cellulitis.									Y	10/22/2003	10/23/2003	1	Cellulitis	PUB	PVT	NONE	NONE	Cervial sprain lumbar,			1						1	Cellulitis; Erythema; Feeling hot; Headache; Urticaria	FLU3~SANOFI PASTEUR~U1270AA~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211068	10/28/2003	TX	24.0	24		F	10/23/2003	She felt light headed, general sense of being unwell, nausea.  We had her rest about 20-25 minutes.									Y	10/22/2003	10/22/2003	0	BP: 131/94; Pulse: 55-65;	PVT	PVT	NONE	NONE	NONE			1						1	Dizziness; Malaise; Nausea	FLU3~SANOFI PASTEUR~U1123AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211070	10/28/2003	NY	39.0	39		F		1) Raised, red, warm to the touch, inflammation at injection site (about 3 inches in diameter) 12 hours after injection. 2) Severe joint pain with about 6 hours after injection.  Treatment: Benadryl about 36 hours after injection.  All symptoms resolved within 48 hours of injection.									Y	10/15/2003	10/15/2003	0	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Arthralgia; Feeling hot; Injection site erythema; Injection site inflammation; Injection site swelling	FLU3~SANOFI PASTEUR~U1253AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211071	10/28/2003	NY	41.0	41		F	10/21/2003	Dizziness, nausea, chills started within 1 hour of vaccine.  Dizziness and chills subsided after 3 hours, nausea persisted for approximately 24 hours.									Y	10/15/2003	10/15/2003	0	NONE	PVT	OTH	Methylphenidone, Topanax, Trazodone	NONE	NONE			1						1	Chills; Dizziness; Nausea	FLU3~SANOFI PASTEUR~U1253AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211072	10/28/2003	NY	50.0	50		F	10/15/2003	Swelling, redness and itching.  After a week it still has a little pain at sight.									Y	10/15/2003	10/15/2003	0	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Erythema; Injection site pain; Oedema; Pruritus	FLU3~SANOFI PASTEUR~U1268AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211073	10/28/2003	NY	48.0	48		M	10/21/2003	Nausea, irratio heart beat, headache, sweating lasting 2 days.									Y	10/15/2003	10/15/2003	0	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Arrhythmia; Headache; Hyperhidrosis; Nausea	FLU3~SANOFI PASTEUR~A1253AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211074	10/28/2003	NY	29.0	29		F	10/21/2003	Nausea, red, swollen									Y	10/15/2003	10/15/2003	0	NONE	PUB	OTH	NONE	RED, SWOLLEN	NONE			1						1	Erythema; Nausea; Oedema	FLU3~SANOFI PASTEUR~U1253AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211075	10/28/2003	ID	62.0	62		F	10/20/2003	Spoke to patient on 10/16/2003.  Patient states having stepped on staple on 10/11/2003 for which she was seen in ED on 10/12/2003 and received Td injection. Patient then saw MD on 10/14/2003, and on that day received pneumococcal and flu vaccines.  Patient states that 2 hours after the injection she developed aching, chills, temperature to 101, joints hurt, shoulder also.  patient had difficulty sleeping and awoke with diaphoresis and nausea/diarrhea.  States she was sitting on commode and passed out.  Could not estimate timeframe of LOC.  States woke up leaning against wall still on commode.  Patient then noted that she was very, very, weak and slowly improved over the course of the day.  Noted in the shower that she had some sore nodes under her left armpit (same arm as she got injection).  Patient pushed fluids and ate solids; voiding QS and was continuing to feel better when I spoke with her on the 16th.  Patient denies shortness of breath, chest pain, palpatations.  Patient informed that she had quite the reaction to the vaccines but was unlikely she was allergic to hem and should be able to receive them in the future although she shouldn't require pneumococcal v.  Patient to take it easy and follow up should she not continue to improve.  Will send VAERS to CDC.  Patient stated verbal understanding and had no further questions at this time.   Patient had bad reaction to flu shot.  Patient is fine now, but would like to know if she is allergic and would like to know if she should not get it again.  This was her first flu shot, and also received shots for pneumonia.									Y	10/14/2003	10/14/2003	0	NONE	MIL	MIL	Lisinopril, Zocor, Folic acid, ASA, Vitamin C,E; Ca2; Focamax, Vioxx	NONE	Coronary Artery Disease, Hypertension, Morphine sulfate, Hyperlipoproteinemia;			1						1	Arthralgia; Chills; Diarrhoea; Insomnia; Loss of consciousness; Nausea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1098AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0165M~2~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211076	10/28/2003	TN	56.0	56		F	10/15/2003	Rash over entire upper trunk except underneath bra. Facial edema. Nail beds cyanotic. Rash appears to be progressing. Oxygen given as well as 50 mg Benadryl IM. Transferred to ER. Was given Phenergan and Steroid IV and Benadryl IM around 2:30 PM. Discharged around 4 PM. Was told not to have vaccinations together anymore, because could not tell which one caused the allergic reaction. 10/15/03: Call to pt. She states had mild difficulty swallowing last PM and some itching today but generally improved. She called her MD and was advised to continue Benadryl until asymptomatic.				Y					Y	10/14/2003	10/14/2003	0		PUB	PUB	Accupril, Advacone, Cerezone, Coumadin, Neurotin, Xanax	Chronic depression	Being txd for chronic depression; Hx Carotid artery dissection 1996, light stroke. Allergies to codeine, Vioxx, Celebrex, Naprosyn, Bextra, Mobic		TN03064	1						1	Dysphagia; Face oedema; Nail discolouration; Pruritus; Rash	FLU3~EVANS VACCINES~765797~4~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TYP~SANOFI PASTEUR~6710M~UNK~IM~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0211077	10/28/2003	GA	52.0	52		F	10/14/2003	Symptoms: sweating, dizzy, lightheaded, pale. Pt experienced these symptoms within 1-2 minutes following vaccination. EMTs took pt to hospital. Dr described event as vasovagal reaction (Pt had recently eaten).				Y					Y	10/13/2003	10/13/2003	0		PUB	PVT						1						1	Dizziness; Hyperhidrosis; Pallor; Syncope vasovagal	FLU3~SANOFI PASTEUR~U1138AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211078	10/28/2003	FL	56.0	56		F	10/22/2003	Pneumovax shot given yesterday on left arm; this morning noticed redness around site and also itchiness. At around mid-morning, site still itchy and redness spread approx 2 inches down (in elongated fashion). Pt took 12.5mg of Benadryl and 400mg of Ibuprofen.									U	10/21/2003	10/22/2003	1		PUB	PUB		NONE				1						1	Injection site erythema; Pruritus	FLU3~SANOFI PASTEUR~U1147AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1079M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211079	10/28/2003	PA	37.0	37		M	10/23/2003	On 10/22/03 AM had about 3 hours of front sided tinnitus and partial deafness. Took aspirin 325mg, went to bed, woke up completely symptom free.									Y	10/20/2003	10/22/2003	2	NONE	PUB	PVT	Strattera, MVI, Prilosec	NONE	GERD			1						1	Deafness; Tinnitus	FLU3~EVANS VACCINES~765710~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211080	10/28/2003	GA	2.0	2	.6	M	10/22/2003	Pt vaccinated on 10/20/03. Received PCV-7 to RL and Fluzone to LL. Pt RTC on 10/22/03 with localized reaction on right thigh. Onset of reaction was 10/21/03. Mom stated it was swollen, red and warm to touch 1 day after PCV-7. Dr made aware of reaction after shot. No recommendation given states parent. 10/22/03 observation: noted 5cm x 2cm reddened area on right thigh. Not warm to touch. Child no c/o pain with examination of area. Advised warm compress to site, seek MD recommendations on Benadryl. Exam performed by RN.									U	10/20/2003	10/21/2003	1		PUB	PUB	NONE	NONE	NKA			1						1	Feeling hot; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1114AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~492854~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0211081	10/28/2003	TX	79.0	79		M	10/22/2003	Erythema and edema arm.									Y	10/20/2003	10/21/2003	1		PVT	PVT	Vioxx, Zocor, Zestril, Proscar, Norvasc, Levothroid, Imdur, Coumadin	HTN, BPH, Hypercholesterol, Hypothyroidism	Sulfa			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1068AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0664N~2~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211082	10/28/2003	WA	44.0	44		F	10/15/2003	Nausea and stomach cramping									Y	10/10/2003	10/11/2003	1		PUB	PVT						1						1	Abdominal pain; Nausea	FLU3~EVANS VACCINES~765670~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211083	10/28/2003	WA	39.0	39		F	10/13/2003	10/6 evening began to have flu-like lower GI symptoms. 10/7 woke up with severe lower backache and joint pain, cramping and nausea. This continued thru the day with low grade fever. 10/8 same symptoms but less severe. 10/9 no symptoms.									Y	10/06/2003	10/06/2003	0	NONE	PVT	PVT	Vitamins	NONE	NKA			1						1	Arthralgia; Back pain; Influenza like illness; Muscle spasms; Nausea; Pyrexia	FLU3~EVANS VACCINES~765670~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211084	10/28/2003	PA	24.0	24		M	10/22/2003	Nausea and vomiting 1 1/2 hours after receiving vaccines. Compazine 10mg stat and tid will follow injection site. Examined abdomen, lungs, heart.									Y	10/22/2003	10/22/2003	0		MIL	UNK						1						1	Nausea; Vomiting	ANTH~EMERGENT BIOSOLUTIONS~FAV076~2~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1098AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211085	10/28/2003	CT	35.0	35		F	10/23/2003	Large red welts on arm flu shot given. Temp 101.									Y	10/20/2003	10/21/2003	1		UNK	UNK		NONE	NONE			1						1	Injection site erythema; Pyrexia; Urticaria	FLU3~EVANS VACCINES~765410~2~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0257N~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211086	10/28/2003	MD	5.0	5		M		Pt return to clinic c/o swollen reaction possibly due to flu vac. Treatment f/u or 24-48 hours or return (?) if symptoms worsens. The follow up received on 11/18/03 states Rx monitor/ comfort measures has recovered.									Y	10/20/2003	10/22/2003	2	NONE	PUB	PUB		NONE		swollen leg~DTP + Hib (no brand name)~1~1.00~In Patient		1						1	Oedema	FLU3~SANOFI PASTEUR~U1268AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211087	10/28/2003	GA	22.0	22		F	10/21/2003	Pt lost consciousness, went into a seizure, stopped breathing, had no pulse. Called 911. Approx 30 seconds went by and pt began breathing on her own. She was checked by EMTs and mom insisted that she go home.									Y	10/17/2003	10/17/2003	0		OTH	PVT	Adderail, Tenormin	Heart condition	Heart condition			1						1	Apnoea; Convulsion; Loss of consciousness; Pulse absent	FLU3~SANOFI PASTEUR~U1087AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211088	10/28/2003	NY	12.0	12		M	10/20/2003	3 minutes after given influenza vaccine, noted to be pale by nurse. C/o lower chest/abdominal discomfort. I was called to room. Child was pale, sweaty, c/o being tired and was saying I feel funny. HR 40 and irregular, got equipment to get BP and O2 sat, when he vomited a large amount, then improved O2 sat 98%. HR 80-82, BP 88/60, monitored 10-15 minutes. Remained stable and states felt so went home.				Y					Y	10/20/2003	10/20/2003	0		PVT	PVT	NONE	NONE	NONE	syncope~Influenza (Seasonal) (no brand name)~~10.00~In Patient		1						1	Abdominal discomfort; Fatigue; Feeling abnormal; Hyperhidrosis; Pallor; Vomiting	FLU3~SANOFI PASTEUR~U1102AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211089	10/28/2003	GA	46.0	46		F	10/27/2003	Rash arms, legs, hands, torso, face began 10/21/03. Tx: Rx Steripred DS Dose pack for 12 days, Rx: Benadryl.									Y	10/16/2003	10/21/2003	5		PUB	PVT		NONE	Asthma			1						1	Rash	FLU3~SANOFI PASTEUR~U1124AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211090	10/28/2003	TX	27.0	27		F	10/09/2003	Vaccine admin around 9:30 AM. NKDA. 1st time to receive vaccine. No food allergies. Pt came to me around 11:30 AM with c/o itching all over. No hives. Noted on body. VS BP 102/76. HR 120 SPO2 98%. Also c/o sore throat, she did not have prior to vaccine. 1 Benadryl 25mg given orally (at 11:35). She started c/o not being able to swallow the Benadryl. Husband notified. At 11:45 pt c/o more difficulties swallowing. 911 notified. .3cc of epinephrine given subq. BP 104/76 99.2 temp, 97%  SPO2 HR 96. Ambulance arrived pt taken to ER.				Y					Y	10/08/2003	10/08/2003	0		OTH	UNK	NONE	NONE	NONE			1						1	Dysphagia; Pharyngolaryngeal pain; Pruritus; Pyrexia	FLU3~EVANS VACCINES~765179~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0211091	10/28/2003	IL	70.0	70		F	10/21/2003	Received influenza vaccine on Friday 10/17/03, left upper arm, some redness developed on Saturday but extended down and around anterior reaching 2 width and 3 length. Pt called our office 10/20/03 and was instructed to check with her doctor. He ordered warm packs to area and it's improved 10/21/03.									Y	10/17/2003	10/18/2003	1	NONE	PUB	PUB		NONE	Previous stroke			1						1	Injection site erythema	FLU3~EVANS VACCINES~765854~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211092	10/28/2003	WI	34.0	34		F		2100 received injection by 2125 took 50mgs PO Benadryl for throat itchiness and tightening, called to ER. By 2200 Dr on unit referred me to ER for additional Benadryl as was red and itching all over entire body. Seen in ER for additional IV Benadryl, Solu-Medrol 125mg. Discharged to home on 10/16/03 about 0030 on 40mg Prednisone for 5 days, 20 mg Zyrtec qd, 50mg PO Benadryl q 6 hours. F/U by another MD 10/16, add 125mg Solu Medrol IM for continued itching, difficulty breathing.				Y					Y	10/15/2003	10/15/2003	0	NONE	PVT	PVT	Zyrtec, Lexapro, Dicyclomine	NONE	Several environmental allergies/milk/pork			1						1	Dyspnoea; Erythema; Pruritus; Throat tightness	FLU3~EVANS VACCINES~765502~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0211093	10/28/2003	AK	69.0	69		F	10/17/2003	Hives below injection site, severe pain in arm and under arm radiating to shoulder blade at 48 hours, couldn't raise arm. Nausea, severe headache, fever for 24 hours, had to stay in bed. Right arm affected.									Y	10/13/2003	10/13/2003	0	NONE	PVT	OTH	Dyazide, Prozac	NONE	PCN; hypertensive cardiomyophy; depression/anxiety			1						1	Headache; Nausea; Pain; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U1141AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0735M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211094	10/28/2003	WA	51.0	51		F	10/10/2003	Joint, bone aching (head, neck, back). Gastric distress. Some chills. Lasted 24-30 hours, reducing over time period.									Y	10/06/2003	10/07/2003	1	NONE	PVT	PVT		NONE	Hayfever, eczema			1						1	Arthralgia; Chills; Pain; Stomach discomfort	FLU3~EVANS VACCINES~765670~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211095	10/28/2003	VA	3.0	3		M	10/17/2003	Fever 103-105 degrees for 4 days. Left arm red, swollen, bluish discoloration elbow to shoulder, pain with movement. Resolved 10/4.									Y	09/30/2003	09/30/2003	0	NONE	PVT	UNK	Claritin, Singulair	NONE	Recurrent otitis media; asthma			1						1	Injection site erythema; Injection site oedema; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1139AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0872M~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211100	10/28/2003	NJ	1.25	1	.3	M	10/27/2003										Y	10/20/2003	10/22/2003	2	NONE	UNK	UNK						1						1	Unevaluable event	DTAP~SANOFI PASTEUR~C1386AA~4~IM~~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1075AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211127	10/28/2003	GA	61.0	61		M		Chills, sweating (fever unknown, did not take temperature). Local swelling, lymph nodes swelled under right arm.									Y	10/21/2003	10/22/2003	1		OTH	PVT						1						1	Chills; Hyperhidrosis; Injection site oedema; Lymphadenopathy	FLU3~SANOFI PASTEUR~U1124AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0872M~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211150	10/28/2003	NY	62.0	62		M	10/28/2003	Running eye, slurred speech, drooping of left side of face. Symptoms appeared appx. 72 Hrs. after flu shot.     CAT scan to rule out stroke.   Famvir 500mg for virus, AKWA tears for eye problem. Medical record states pain. msv				Y					Y	10/22/2003			CAT Scan	UNK	UNK	Glynase 3 Metformin HCL 1000	none	diabetic			1						1	Dysarthria; Facial palsy; Lacrimation increased; Pain	FLU3~SANOFI PASTEUR~unknown~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211153	10/28/2003	TX	45.0	45		F	10/28/2003	PATIENT FAINTED APPROXIMATELY 1 MINUTE AFTER BEING ADMINISTERED THE INFLUENZA VACCINATION.  NO S/S WERE PRESENT TO ME (THE VA) PRIOR TO BEING GIVEN THIS SHOT.  PT WAS PLACED ON THE FLOOR, AND AFTER ABOUT 2 MINUTES, SHE AWAKENED.  PATIENT HAD NO RECOLLECTION OF THE EVENT.  HER PULSE WAS TAKEN AT THIS TIME, AND IT WAS 54 BPM.  AMBULANCE WAS CALLED, AND PATIENT WAS CHECKED OUT BY THE PARAMEDICS, BUT SHE REFUSED TO GO TO THE HOSPITAL.  SHE WAS GIVEN A SODA AND ASKED TO SIT IN OUR WAITING ROOM FOR A FEW MINUTES.  HER HUSBAND WAS CALLED TO COME AND PICK HER UP.  I BELIEVE SHE WENT TO THE DOCTOR 2 DAYS LATER AND WAS TOLD THAT SHE WAS VERY FATIGUED AT THE TIME THE VACCINE WAS ADMINISTERED.  PT HAS RECEIVED FLU SHOTS IN THE PAST WITH NO PROBLEMS.				Y					Y	10/15/2003	10/15/2003	0		UNK	PVT		NO	NO			1						1	Fatigue; Syncope	FLU3~SANOFI PASTEUR~U1095AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211155	10/28/2003	MO	65.0	65		M	10/22/2003	Dizzy, nauseated, shaking, difficulty breathing apporx.  1-2 hours after receiving vaccine.  Taken by ambulanc to Heartland ER.  Symptoms had subsided by the time they reached the ER.				Y					Y	10/22/2003	10/22/2003	0		UNK	UNK					MO200387	1						1	Dizziness; Dyspnoea; Nausea; Tremor	FLU3~EVANS VACCINES~765854~2~ID~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0211156	10/28/2003	MT	56.0	56		F	10/28/2003	Intense itching in upper L arm. Area hot, some swelling, red, blotchy.  sweaty/clamy.  No shortness of breath, swelling of lips,tongue.  Refused Benadryl. Refused epinephrine injection. Area iced and patient observed closely. Itching, warmth, reddness disappeared approximately 45 minutes after flu injection									Y	10/23/2003	10/23/2003	0		PUB	PUB	Blood pressure medication Heart medication	None	asthma, high blood pressure, heart problems			1						1	Cold sweat; Face oedema; Hyperhidrosis; Injection site erythema; Injection site swelling; Injection site warmth; Pruritus; Rash macular; Tongue oedema	FLU3~SANOFI PASTEUR~U1122AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211157	10/28/2003	TX	72.0	72		F	10/28/2003	PATIENT WAS GIVEN BOTH THE FLU SHOT AN PNEUMONIA SHOTS ON 10/15/03.  A FEW HOURS AFTER SHE RECEIVED THEM, SHE WENT HOME AND HER RIGHT ARM BEGAN SWELLING (RIGHT ARM-FLU/LEFT ARM-PNEUMONIA).  SHE CLAIMS THAT IT WAS DOUBLE THE SIZE THAT IT IS NORMALLY.  SHE ALSO STATED THAT SHE FELT WEAK.  LATER ON IN THE AFTERNOON, BETWEEN 4 AND 5 PM, SHE WENT TO EAT DINNER WITH A NEIGHBOR AND BEGAN FEELING VERY ILL.  THEY LEFT THE RESTAURANT AND WHEN SHE GOT HOME, SHE FAINTED.  THE PARAMEDICS WERE CALLED BUT DID NOT FIND ANYTHING ON EXAMINATION. SHE CONTINUED TO FEEL VERY BAD FOR THE NEXT 4 DAYS, AND ON 10/20/03 SHE WENT TO HER PHYSICIAN.  HE ALSO EXAMINED HER AND FOUND NOTHING. I SPOKE WITH HER TODAY, AND SHE STATED THAT SHE STILL DOES NOT FEEL WELL. PATIENT HAS RECEIVED FLU VACCINES IN THE PAST WITH NO PROBLEM.  I ALSO ASKED HER IF THE SHOT HURT WHEN IT WAS ADMINISTERED.  SHE CLAIMS THAT THERE WAS A SLIGHT STINGING SENSATION BUT NO SEVERE PAIN.				Y					N	10/15/2003	10/15/2003	0	NOTE: TIMES OF VACCINATION AND ADVERSE EVENT ONSET ARE ESTIMATES.  THEY ARE NOT EXACT.	UNK	PUB	NONE AT THE TIME	NO	NO			1						1	Malaise; Oedema peripheral; Pain; Syncope	FLU3~SANOFI PASTEUR~U1095AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0445M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211238	10/28/2003	WV	23.0	23		M	10/28/2003	History of Present Illness:  Patient developed pleuritic chest pain two weeks after receiving his primary SPV, typhoid vaccination, and influenza vaccination and was admitted to Medical Center with a diagnosis of myopericarditis.  See table below. Primary Smallpox Vaccination (L arm) Influenza, Typhoid PPD  10 Oct 03 No problems on this date.  Reports he had received the briefing on smallpox vaccination. 18 Oct 03 While shooting at the 9mm range, he began experiencing a headache, ringing in his ears, and chest pain.  He described the chest pain as localized to his left side.  Rated it as a 5-6 on a 0 (no pain)  10 (worst pain ever) scale.  Took Advil with slight relief. After leaving the rifle range, his headache persisted but the chest pain had eased off.  He was able to fall asleep but was awakened from his sleep around 1 AM with chest pain.   19 Oct 03 Chest pain continued and at approximately 7:30 am, he was experiencing sharp, stabbing pain that had increased to a 7-8 on a pain scale.  Pain also radiated down his left arm.  Worse with inspiration.  Noted the pain even without exertion.  Experienced shortness of breath with the pain.  Also complained of a dry cough. Service member reports that he has had episodes of chest pain in the past but they were not similar to this chest pain.  Previously it was centered on the left side of his chest with no radiation.  At times, the pain could increase to a 5-6 on the pain scale.  No change with breathing or exertion.  No complaints of heartburn.  Has not been medically evaluated in the past for chest pain. Went to Medical Center Emergency Room and was admitted with a diagnosis of myocarditis.  EKG normal but cardiac enzymes elevated.  Initial CXR was normal. 20 Oct 03-23 Oct 03 Remained hospitalized at Medical Center.  Medications included aspirin 325 mg po QID, Morphine 2 mg prn pain, Percocet prn pain, Ibuprofen 800 mg q 8 hr, and Lovenox 100 mg q 12 hr.  He also had some temperature spikes while in the hospital.  Blood and urine cultures were negative.  He was placed on Tylenol 650 mg q 4-6 hours prn.  Through the course of hospital stay, patient's chest pain and headache resolved.  No further shortness of breath.  Follow-up CXR showed small left pleural effusion.  Echocardiogram showed LVEF =45-50%.  Cardiac enzymes decreased and patient was discharged home on 23 Oct 2003.  He was placed on a 6-month convalescent leave. 27 Oct 03 Follow-up conducted with patient at home.  No further complaints of chest pain or shortness of breath.  He was discharged on Motrin prn but has not needed it.  He has a follow-up appointment with the Hospital tomorrow. 60-day follow up 2/17/04:  He continues to experience occasional exertional chest pain approximately once every 3 days, along with some dyspnea on exertion. He is now due for his 6-12 month follow up. Once the evaluation is completed, I will file a follow up report.			Y	Y	Y	4			Y	10/10/2003	10/18/2003	8	Diagnostic Tests: EKG-Per report-WNL with no ST changes Echocardiogram:  20 Oct 2003 oMildly reduced LVEF = 45-50%, Mild global hypokinesis.  No left ventricular hypertrophy or enlargement.  No pericardial effusion.  Normal left atrium.  Normal mitral valve.  No aortic stenosis or regurgitation.  No tricuspid regurgitation.  Normal right ventricle.  Chest PA/LAT: o22 Oct 2003-Impression:  There has been interval development of a small left pleural effusion.  Findings:  There has been no interval change in the cardiac size.  There is blunting of the left costophrenic angle suggestive of a small effusion. o19 Oct 2003-Impression:  Normal PA and Lateral Chest.  Findings:  The lungs are normal in appearance without evidence of active disease.  The cardiac silhouette and great vessels are within normal limits.  The mediastinum, pleura, diaphragm, and bony thorax are unremarkable.  Head CT without contrast:  19 Oct 2003:  Normal noncontrast CT of the head.   Laboratory Data:  Cardiac Enzymes: Date CK (22-269) CK-MB(2.3-9.5) Relative Index(0-2.5) Troponin I (0-1.5) 10/23/03 @ 0604 108   1.62 H 10/21/03 @ 1830 326 H 5.8  4.97 H 10/20/03 @ 0032 591 H 13.4 H 2.3 7.48 H 10/19/03 @ 1820 635 H 14.7 H 2.3 14.36 H 10/19/03 @ 1215 559 H 12.2 H 2.2 7.76 H 10/19/03 @ 0949 476 H 7.2  1.58 H  CBC:   o21 Oct 03:  WNL except RBC = 4.25 L (4.4-5.9), HGB = 12.3 L (13.0-17.2), HCT = 36.0 L (39-52) o19 Oct 03:  WNL except WBC = 4.0 L (4.4-11.0), HCT = 37.9 L (39-52), Mono% = 12.1 H (0.0-12), Lymph # = 0.5 L (0.6-3.4)  Chemistry: o19 Oct 03:  WNL except CA 8.5 L (9.0-10.5)  ESR (10/21/03) = 21 H (0-15)  Urinalysis:   o22 Oct 03-WNL except 20 RBC, 250/UL Blood o19 Oct 03- WNL except 38 RBC, 150/UL Blood, Occasional Bacteria Urine Culture:  21 Oct 03-No growth Blood Culture:  No growth  Lyme AB:  Pending Rickettsi IGM:  <1:64-Negative C Burnet AB:  <1:16-Negative E Chaffee IGG:  Negative E Chaffee IGM:  Negative HGE IGG Titer:  Negative HGE IGM Titer:  Negative ASAP Myoglobin:  87.30 (0-110)  Urine Drug Screen:   oNegative Amphetamines, Barb, Benzodiaz, THC, Cocaine, Opiates, Phencyclidine, TCA. oPositive:  Opiates  ASAP Ethanol Level (19 Oct 03):  < 5 (<5 = Below detectable limits) Acetaminophen (19 Oct 03): < 10 (10-30) Salicylates (19 Oct 03):  < 4.0 (10-30)	MIL	MIL	None	None	Past Medical History: oHistory of frequent heat injuries (no hospitalizations for the heat injury) oFrequent Nosebleeds oHTN-Previously on medication but no HTN meds recently. oChronic knee and back pain oPast history of chest pain-See HPI, denies heartburn or GERD symptoms. oDenies any history of asthma, DM, heart murmur, cancer, immunosuppression, skin disorder, or thryroid dysfunction.  Allergies/ Adverse Drug Reaction History: oNo known food or drug allergies			1						1	Chest pain; Cough; Dyspnoea; Headache; Laboratory test abnormal; Myocarditis; Pleural effusion; Pleurisy; Tinnitus; Chest pain; Dyspnoea; Fatigue; Headache; Laboratory test abnormal; Nausea; Pericarditis; Vision blurred	FLU3~PFIZER\WYETH~~1~IM~UN~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|SMALL~PFIZER\WYETH~~1~ID~LA~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~W0909~1~IM~UN~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|SMALL~PFIZER\WYETH~~1~ID~LA~SMALLPOX (DRYVAX)~2|TYP~UNKNOWN MANUFACTURER~W0909~1~IM~UN~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation	Influenza
0211239	10/28/2003	MT	74.0	74		F	10/28/2003	c/o nausea, vomiting, R upper arm very sore, swelling in this arm, hot, red, sweaty, achy, dizzy.  no shortness of breath, swelling of tongue, wheezing.  Refused to go to ER.  Recommended icing area for short period, being quiet, ibuprofen/tylenol and if things changed to go to the ER.  Arm was swollen approx 3x the size of the other arm on day 2.  Also had fluid which extended down to elbow.  Very red, very hot.  On day 5 fluid was disappearing, swelling down, and heat and redness disappear.									Y	10/23/2003	10/23/2003	0		PUB	PUB	unknown	none	unknown			1						1	Dizziness; Erythema; Feeling hot; Hyperhidrosis; Nausea; Pain; Swelling; Vomiting	FLU3~SANOFI PASTEUR~U1122AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0530N~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211241	10/28/2003	CA	51.0	51		F	10/28/2003	Temp: 103.3; extreme pain in vaccinated arm resulting in inability to move or lift arm; nausea, headache; symptoms unset less than 24 hrs after injection. TX: Tylenol and bedrest									Y	10/20/2003	10/21/2003	1		PVT	UNK	Allegra, Singulair	none	asthma, steroid allergy			1						1	Headache; Joint range of motion decreased; Nausea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~HU1078AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~P0604N~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211242	10/28/2003	MS	76.0	76		M	10/21/2003	10/14 slight soreness in arm that night 10/16 redness and swelling on underside of L upper arm				Y					Y	10/14/2003	10/16/2003	2	none	PUB	PUB	none	none	none		MS03086	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1094AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0820M~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211243	10/28/2003	PA	65.0	65		F	10/11/2003	diffuse erythema around injection site of pneumovax				Y					U	10/08/2003	10/09/2003	1	none	PVT	UNK		none	none			1						1	Injection site erythema	FLU3~EVANS VACCINES~765416~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0068N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211245	10/28/2003	VA	20.0	20		F	10/28/2003	RECD ANTHRAX #4 ON 10/22/03, ON 10/25/03 ARM SWOLLEN, HARD RED, HOT, PRURITIC FROM ARM PIT TO ELBOW. ARM WAS ALSO PAINFUL 5/10. WNET TO ER AND WAS GIVEN MOTRIN, BENADRYL, AND VICODIN. FOLLOWING MORNING SOMEWHAT RESOLVED. NOT COMPLETELY RESOLVED AS OF YET 10/28/2003.				Y					Y	10/22/2003	10/25/2003	3		MIL	MIL	NONE	NONE	ALLERGY TO PENICILLIN			1						1	Erythema; Injection site induration; Injection site warmth; Oedema peripheral	ANTH~EMERGENT BIOSOLUTIONS~UNKNOWN~4~SC~RA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~UNKNOWN~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0211247	10/28/2003	AZ	0.0	56		F	10/28/2003	generalized hives and pruritis; onset within 10-15 post injection.  Diphenhydramine 25mg administered within 30 minutes of injection.  Patient monitored for 2 hours with symptoms mostly resolving with only slight redness upon discharge.									Y	10/15/2003	10/15/2003	0		PUB	UNK	unknown	unknown	post polio syndrome--  otherwise unknown			1						1	Pruritus; Urticaria	FLU3~EVANS VACCINES~765798~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211248	10/28/2003	WI	48.0	48		F	10/28/2003	36 hr. after vaccine. Mild rash and itching developed. By 48 hr. rash was severe widespread. Treated with 40 mg. predisone X 4 days along with benedryl. Symtoms gone after 3 days.				Y					Y	10/22/2003	10/24/2003	2		PUB	UNK		none				1						1	Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~765854~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0211249	10/28/2003	UT	12.0	12		M	10/28/2003	RED, TENDER SWELLING ON RIGHT LATERAL DELTOID 2 1/2 X 1 3/4									Y	10/24/2003	10/26/2003	2		PVT	PVT	ADVAIR	NONE	NONE			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1142AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1196M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211250	10/28/2003	CA	70.0	70		U	10/28/2003	Had flu shot at noon on 21st of October.  By noon next day had body aches.  Pulse was 100 and body temperature was 99.8.  The fever subsided by midnight.  I still feel fatigued although it has been one week since I had the shot. Vaccine lot No. U1256AA, Manufacturer Adventis									Y	10/21/2003	10/22/2003	1		UNK	UNK		None	Type 2 diabetes			1						1	Fatigue; Heart rate increased; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1256AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211160	10/29/2003	WA	69.0	68		M		This subject is a 69 year old male who died while enrolled in RSV11 S & I study with RSV vaccine. The subject received RSV vaccine or Placebo and influenza vaccine on 10/22/02. The subject died 342 days post immunization on 10/01/2003. Subject was admitted on 9/29/03. He was transferred from ICU post AKA for decrease MS and possible CHF exacerbation. He was volume overloaded on admission and IV diuresis was started. Pt showed bilateral DVT's and was placed on Heparin and then Lovenox the same day. He remained stable until October 1, 2003 in the evening when he was found unresponsive and pulseless. Subject expired more than 30 minutes of unsuccessful resuscitation. Diagnosis: DVT with presumed PE, cardiopulmonary failure secondary to DVT, CHF exacerbation, DM, GRI, and altered MS. The death was reported by the investigator as not related to the study vaccine. Follow up on 11/26/03: Initial SAE report received on 10/22/03.  This subject is a 69 year old male who died while enrolled in RSV11 S & I study with RSV vaccine.  The subject received RSV vaccine or Placebo and Influenza vaccine on 10/22/02.  The subject died 342 days post immunization on 10/01/2003.  Subject was admitted on 09/29/03.  He was transferred from ICU post AKA for decreased MS and possible CHF exacerbation.  He was volume overloaded on admission and IV diuresis was started.  Patient showed bilateral DVT's and was placed on Heparin and then Lovenox the same day.  He remained stable until 10/01/03 in the evening when he was found unresponsive and pulseless.  Subject expired after more than 30 minutes of unsuccessful resuscitation.  Diagnosis:  1) DVT with presumed PE. 2) Cardiopulmonary failure secondary to #1. 3) CHF exacerbation. 4) DM. 5) GRI. 6) Altered MS. The death was reported by the Investigator was not related to the study vaccine.  Additional information received 11/18/03.  Death certificate: Cause of death: Pulmonary Embolism due to deep vein thrombosis due to congestive heart failure.  The pulmonary embolism secondary to deep vein thrombosis secondary to congestive heart failure was reported by the investigator as not related to the study vaccine.	Y	10/01/2003			Y	3			N	10/22/2002	09/29/2003	342		UNK	UNK	RSV/Placebo, Allopurinol, Atenolol, Furosemide, Simvastatin, ASA, insulin, Mirtazapine, Doss, Loperamide, Simethicone		DM, CHF, CAD, PVD, gout, UTI (recurrent). Above the knee amputation		200302676	1						1	Cardiac failure; Coma; Condition aggravated; Deep vein thrombosis; Fluid overload; Mental impairment; Pulse absent	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0211172	10/29/2003	TX	55.0	55		F	10/23/2003	4 hours after shot, shaking both arms, no loss of consciousness, no biting tongue, not aware of situation.				Y	Y	1			Y	10/15/2003	10/15/2003	0	EKG; Brain Scan	PUB	PUB	Norvasc 5mg; Lipitor 20mg; Centrum vitamins; Calcium plus Vitamin D; Garlic; Vitamin C; Vitamin E; B100 complex.	Allergy	Thyroid; HTN			1						1	Tremor	FLU3~SANOFI PASTEUR~U1074AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0211174	10/29/2003	CA	76.0	76		M	10/20/2003	Left hand numb, upper lip, left cheek, left foot/toes numb. Left hand cold compared to right. Told to report to local ER. Went to clinic this hospital. Admitted for CVA. Discharged 10/18/03 as reported by patient. 60-day follow up on 02/02/04: No new information received.				Y	Y	2			U	10/14/2003	10/15/2003	1		MIL	OTH	Metformin; Atenolol; Lovastatin; Lisinopril; Flanisolide; HCTZ		Tinea Veriscolor; Hyperlipidemia; Tremor; Hyperglycemia; Hypertension; Hemorrhoids; Benign prostatic hypertrophy			1						1	Cerebrovascular accident; Hypoaesthesia; Peripheral coldness	FLU3~SANOFI PASTEUR~U1260AA~UNK~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0211175	10/29/2003	OR	46.0	46		F	10/22/2003	Dizziness, no loss of consciousness. 1 event was fine within a few minutes. Pt has no underlying disease and currently in good health.									Y	10/14/2003	10/21/2003	7		OTH	PVT		NONE	NONE	passed out~Vaccine not specified (no brand name)~1~36.00~In Patient		1						1	Dizziness	FLU3~EVANS VACCINES~765144~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211176	10/29/2003	IL	39.0	39		F	10/21/2003	On 10/17/03 around 12 noon she began feeling aches. At around 3pm she began feeling feverish and flushed. At 7pm her temperature was 102 orally. The fever, chills, aches, pains and lack of appetite lasted for 48 hours. On 10/18/03 at 7am her temp was 99.8 and at 8pm her temp was 101.5. She had also experienced dizziness, this started on 10/18/03 and lasted through this am 10/21/03. She also noted two hard nodules at the base of her skull; these are still present but have improved. Overall she feels 100% better as of this afternoon 10/21/03. She admits to a history of asthma, but currently not having any symptoms. Also, she is breast-feeding her 10-month-old baby. The Monday (10/13/03) before she got the flu shot her baby had been sick with a three-day viral condition, which included vomiting, fever, and minimal diarrhea.									Y	10/16/2003	10/17/2003	1		OTH	OTH	Singulair, Fenugreek	NONE	Allergy to dust mite, sulfur dioxide, bee stings			1						1	Anorexia; Chills; Dizziness; Flushing; Pain; Pyrexia; Skin nodule	FLU3~SANOFI PASTEUR~U1094AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211177	10/29/2003	GA	4.0	4		F	10/20/2003	Area around injection site red and swollen 14.5 x 9cm.									U	10/16/2003	10/17/2003	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site oedema	DTAP~SANOFI PASTEUR~C1527AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1097AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W1440~4~IM~RL~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0171N~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0211179	10/29/2003	AZ	57.0	57		F	10/17/2003	Fever, chills, muscle aches starting 48 hours after shot. Diarrhea and headache also prominent.									Y	10/03/2003	10/05/2003	2		OTH	PVT						1						1	Chills; Diarrhoea; Headache; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1090AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211180	10/29/2003	AK	70.0	70		F	10/15/2003	Returned day after vaccine given with swelling and tender in left upper arm. 3 x 4cm area of swelling.				Y					Y	10/14/2003	10/14/2003	0		PVT	UNK		NONE	Dilitazem and Elavil			1						1	Injection site oedema; Pain	FLU3~SANOFI PASTEUR~U1141AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0541M~3~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211181	10/29/2003	AZ	4.0	4		M	10/22/2003	Day after vaccine admini - allergic reaction, sterile abscess. Red, swollen, hot to touch arm.				Y					U	10/20/2003	10/22/2003	2	NONE	PVT	PVT		Asthma exac.-mild	NKDA			1						1	Abscess; Hypersensitivity; Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U1093AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211182	10/29/2003	PA	49.0	49		F		Reported onset of cough, sore throat, fever, weakness on 10/23/03, states symptoms are somewhat better today (10/24), but remains weak with lingering cough.									U	10/21/2003	10/23/2003	2		MIL	MIL		NONE	NONE			1						1	Asthenia; Cough; Pharyngolaryngeal pain; Pyrexia	FLU3~EVANS VACCINES~765795~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211183	10/29/2003	CO	73.0	73		F	10/22/2003										Y	10/16/2003	10/18/2003	2		PVT	PVT	Accolate, Lotensin, Climara	NONE	PCN; chronic bronchitis, hx pneumonia			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~41099AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0256N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211184	10/29/2003	OH	80.0	80		F	10/21/2003	Nausea and vomiting starting 10/18/03, pt to PCP started on antiemetic. Still having nausea and vomiting, poor food/fluid intake.									Y	10/15/2003	10/18/2003	3		PUB	OTH		NONE	NKA			1						1	Nausea; Vomiting	FLU3~SANOFI PASTEUR~U1098AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211185	10/29/2003	NE	46.0	46		F	10/23/2003	Temp 101, chilling, muscle aches, headache									Y	10/15/2003	10/15/2003	0		OTH	PVT		NONE				1						1	Feeling cold; Headache; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1078AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211186	10/29/2003	NY	5.0	4		M	10/22/2003	Pt reported legs/feet were numb, unable to wiggle toes or move feet, was able to stand but c/o dizziness. Deny pain/injury. Pt seemed confused to mother. Taken to ER by parents. Medical records state allergic reaction, foot pain. msv				Y					U	10/20/2003	10/20/2003	0		PVT	UNK	Singulair, Albuterol, Pulmicort, Cefzil	Cough, RAD, sinusitis	Sensitivity reaction Amox rash. Asthma, RAD			1						1	Confusional state; Dizziness; Hypersensitivity; Hypoaesthesia; Pain in extremity	FLU3~SANOFI PASTEUR~U1075AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W1440~4~SC~LA~POLIO VIRUS, INACT. (POLIOVAX)~1	USA	Emergency room visit	Influenza
0211187	10/29/2003	TX	30.0	30		F	10/24/2003	Immunized at 11:00 AM. About 2:00 PM had local reaction at injection site. About 5:00 PM had difficulty breathing. Took Albuterol nebulizer then and every 4-6 hours. Saw doctor 10/23/03 at noon and was told she had allergic reaction. Told to use nebulizer and Aleve. Had temp 104 degrees.				Y					Y	10/22/2003	10/22/2003	0		PUB	PUB	Zoloft, Advair, Toprol, Albuterol, Lotril, Singulair	NONE	Asthma, HTN, depression. Allergic to: PCN, sulfa, steroids, Tricyclen, codeine			1						1	Dyspnoea; Hypersensitivity; Pyrexia	FLU3~SANOFI PASTEUR~U1092AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211188	10/29/2003	OH	45.0	45		F	10/22/2003	Hoarseness then hives that ended that night (on face). Wheezing started 10/15/03, used Albuterol inhaler and Claritin-D and reg. until Dr visit 10/19/03. Rx Prednisone Z-Pak.				Y					Y	10/15/2003	10/15/2003	0	Asthma	PUB	UNK	Paxil	NONE	Seasonal allergies			1						1	Asthma; Dysphonia; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U1098AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211189	10/29/2003	PA	15.0	15		M	10/24/2003	Pt received his 1st flu shot, went to waiting room to check out. He felt funny while sitting, then fell forward onto the floor, hitting his head and possibly having a brief seizure. He was incontinent, but got up into chair. He did not respond to voice for about 1 minute but then was helped onto the floor in a recovery position. BP and pulse were low initially then nl. Accucheck 103 (after Gatorade).									Y	10/23/2003	10/23/2003	0	Accucheck 103	PVT	PVT		NONE	Tourette's syndrome			1						1	Convulsion; Fall; Feeling abnormal; Heart rate decreased	FLU3~SANOFI PASTEUR~U1269AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211190	10/29/2003	CA	42.0	42		F	10/22/2003	Reports about an hour after getting her vaccine she noticed raspiness in voice. Noticed at lunch she felt some mild difficulty swallowing. Voice became increasingly hoarse. Did not seek medical care. Did not take antihistamine. Sx lessened. Slight residual hoarseness today.									Y	10/21/2003	10/21/2003	0	NONE	MIL	UNK	Effexor	Reports allergy sx this season	Allergies to ragweed, cats, other unknown seasonal allergies			1						1	Dysphagia; Dysphonia	FLU3~EVANS VACCINES~765140~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211191	10/29/2003	NC	2.0	2	.8	M	10/27/2003	Hives started evening of flu shot. Covering legs, back, arms, feet. Received 10/17/03. Itchy. Treated with Benadryl and Calamine cream/lotion.									N	10/17/2003	10/17/2003	0		PVT	PUB	Xopenex, Pulmicort	Rash on both thighs before shot	Asthma, allergic to peanuts			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1088AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211192	10/29/2003	IL	66.0	66		M	10/28/2003	Fever of 101 degrees for 2 days post injection. Redness, warmth, swelling at injection site. Equilibrium off.				Y					U	10/24/2003				OTH	PUB		NONE	Sulfa; hypertension			1						1	Balance disorder; Feeling hot; Injection site erythema; Injection site oedema; Pyrexia	FLU3~EVANS VACCINES~765854~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0358M~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211193	10/29/2003	AK	57.0	57		M	10/28/2003	Flu shot given 10/24 about 2 PM. No unusual sx noted until 8:30 AM after intense yoga. Pt felt over exerted, achy, fatigue, mild malaise. Sxs continued, not worsening, until 10/27/03. On 10/26, pt noted burning on left side of neck, superficial. Pt noted a pain and ache from left neck down to injection site on left arm. Pt did not examine himself until 10/27/03 at 6 PM, he saw a scattered groupings of pin like pustules, raised. No bleeding. No discharge. More itching, less heat. Discussed case with MD, ruled out shingles.				Y					U	10/24/2003	10/25/2003	1		UNK	UNK		NONE	Allergy to gasoline, hx migraine.			1						1	Fatigue; Injection site swelling; Malaise; Pain	FLU3~SANOFI PASTEUR~U1141AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211194	10/29/2003	MN	76.0	76		M	10/27/2003	c/o soreness at site. Upper arm swollen. Took pain medication, applied ice.									Y	10/20/2003	10/20/2003	0	NONE	PVT	UNK	Lipitor, Prinivil, Xalatan, fiber, Trazadone, ASA, insulin, Fosamax, Advair, Naconex, vitamins, Amatyl Detrol, Bactrim, Prednisone		NKA. Diabetes, asthma, osteoporosis, lowered vision & hearing, GERD, CAD, HTN, glaucoma, hyperlipidemia			1						1	Injection site oedema; Pain	FLU3~SANOFI PASTEUR~U1073AB~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0604N~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211195	10/29/2003	MN	75.0	75		F	10/28/2003	Limited mobility of arm. Arm swollen, red, hot to touch. Applied ice, took pain medication.									Y	10/20/2003	10/20/2003	0	NONE	PVT	PVT	Citrucel, multivit, cranberry	NONE	Scoliosis, degenerative joint disease, lung nodule, splenic artery aneurysm			1						1	Injection site erythema; Injection site oedema; Injection site warmth; Joint range of motion decreased	FLU3~SANOFI PASTEUR~U1073AB~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0604N~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211196	10/29/2003	OH	45.0	45		F	10/28/2003	10/21: flu shot given. 10/22: localized mild soreness with mild inflammation and 3 hives near site. 10/23: seen in clinic for the above and it was noted as a localized reaction. 10/24: pt reports waking with itching to face and extremities with NO rash/SOB noted. Resolved.									Y	10/21/2003	10/22/2003	1		OTH	OTH	Bextra, Inderal, Prevacid, Duratus	NONE	Floxcin, Ceftin, Duricef, Biaxin			1						1	Injection site inflammation; Pain; Pruritus; Urticaria	FLU3~EVANS VACCINES~765139~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211197	10/29/2003	CA	56.0	55		F	10/28/2003	Developed Bell's Palsy two days after Fluzone vaccine. The medical record received on 12/10/03 states laryngitis. Medical records sttes ear pain. msv									U	10/22/2003	10/24/2003	2		PUB	PUB	Steroids 2 weeks before	Arthritis	Arthritis			1						1	Ear pain; Facial palsy; Laryngitis	FLU3~SANOFI PASTEUR~U1093AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211198	10/29/2003	CO	60.0	60		F	10/28/2003	Whole body felt hot (continuous hot flash) all night, next day swelled arm from injection area to elbow and really red. Doctor treated with Allegra (for 1 day) and then with medrol and benadryl. Even today have ache around elbow. Sick to stomach while taking medication. Problem with left arm (pneumococcal).				Y					U	10/15/2003	10/16/2003	1		UNK	UNK	NONE	NONE				1						1	Hot flush; Injection site erythema; Injection site oedema; Nausea; Pain	FLU3~EVANS VACCINES~765601~UNK~~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0955M~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211199	10/29/2003	CT	5.0	5		M	10/15/2003	Received flu vaccine IM 6:00 PM, 15 minutes later mother noted cough, wheeze, itchy neck, hive-like rash x 2mo. Mom gave albuterol puffs, less rash.									Y	10/13/2003	10/13/2003	0		PVT	PVT	Albuterol, MDI		Preemie; CP, congenital heart defect (VSD s/p repair), asthma			1						1	Cough; Pruritus; Rash; Wheezing	FLU3~SANOFI PASTEUR~U1097AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211200	10/29/2003	MI	48.0	48		F	10/23/2003	At 4 AM woke up during night with nausea. Then during next day 10/22 felt light headed and difficulty concentrating and just felt weak and not well. Then on 10/23 developed localized reaction red, raised area on arm approx 2.5mm and developed cough. No fever or any other symptoms.									U	10/21/2003	10/22/2003	1		PUB	PVT	Lipitor, Prilosec	NONE	PCN, Septra, Nubain			1						1	Asthenia; Cough; Disturbance in attention; Dizziness; Malaise; Nausea; Rash erythematous	FLU3~SANOFI PASTEUR~U1078AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211201	10/29/2003	ND	51.0	51		F	10/22/2003	States she has shot anxiety. States she normally has sinus and allergy problems. Sinuses cleared after the shot until 4 PM when they filled and she became itchy all over. Benadryl didn't work well. The sxs subsided about 24 hours later. Left with dry and itchy skin. No local reaction. Has not seen a Dr.									Y	10/20/2003	10/20/2003	0	NONE	PUB	PUB		None acute	Allergies, sinus problems		ND0316	1						1	Dry skin; Pruritus; Sinus congestion	FLU3~EVANS VACCINES~765180~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211202	10/29/2003	NC	48.0	48		F	10/23/2003	Approx 20 minutes after injection I experienced a feeling of lump in my throat, following this I began to have a tingling of both upper extremities and a feeling of anxiety, then a surreal feeling. I went to ER to report possible adverse response but I was only tx'd with Ativan. HR was increased to 150, very anxious feeling.				Y					Y	10/18/2003	10/18/2003	0	Cardiac monitoring in ER (no known abnormality except tachycardia)	PVT	PVT	Synthroid	NONE	Allergy to PCN, codeine; hx of hypothyroidism	local reaction~Influenza (Seasonal) (no brand name)~~45.00~In Patient		1						1	Anxiety; Paraesthesia; Throat tightness	FLU3~SANOFI PASTEUR~U1132AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211203	10/29/2003	PA	55.0	55		F	10/24/2003	Swelling of left leg and calf (7 hours post injection)									U	10/21/2003	10/21/2003	0		OTH	PVT		NONE	UNK			1						1	Injection site oedema	FLU3~SANOFI PASTEUR~U1269AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211204	10/29/2003	MI	63.0	63		F	10/23/2003	Received influenza vaccine 10/16/2003, 3-4 days later developed intense itching - palms of hands, under arms, no external rash, has received influenza vaccine past 3 years, no new meds, no new environmental changes, no egg, latex or thimerosal allergies.									Y	10/16/2003	10/18/2003	2	B/P was elevated when taken 10/22/03.	PUB	PUB	Prempro, hydrochloride	Cold symptoms at time of vaccine	High blood pressure			1						1	Pruritus	FLU3~SANOFI PASTEUR~U1145AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211222	10/29/2003	KS	8.0	8		F	10/20/2003	Deltoid muscle is swollen with erythema 4 1/2 long x 4 wide. Very warm to touch and painful. Severe redness from shoulder to elbow. Skin is tight.									Y	10/17/2003	10/18/2003	1		PVT	PVT		NONE				1						1	Feeling hot; Injection site erythema; Injection site oedema; Pain	FLU3~SANOFI PASTEUR~U1271AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0845AA~4~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0211251	10/29/2003	PA	3.0	3		M	10/29/2003	* entire upper arm (above elbow) became swollen. * upper arm skin became bright red and hot. * upper arm skin was tender, possibly sore, and itchy. * swollen, bright red, hot area of arm steadily increased in size to approx 6 inches by 4 inches by 48 hours after shot. * initial symptoms developed within 24 hours after shot was given. * doctor recommended benedryl allergy formula every 6 hours. Seen in office confirmed reaction as related to flu vax.				Y					U	10/25/2003	10/26/2003	1		PVT	PVT	pulmicort respules		asthma			1						1	Erythema; Injection site pain; Injection site warmth; Oedema peripheral	FLU3~SANOFI PASTEUR~U1269AA~3~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211308	10/29/2003	WA	41.0	41		F	10/29/2003	12 hours after flu shot, felt light-headed and had abdominal pain.  Chills soon followed and kept me awake for ~3 hours.  The abdominal pain peaked about 14-16 hours after the shot and remains now, about 24 hours after the shot; am also feeling warm and appear flushed 24 hours later.									U	10/28/2003	10/28/2003	0	None	UNK	UNK	81 mg baby aspirin 4 hours prior to vaccination	tail-end of mild head-cold				1						1	Abdominal pain; Chills; Dizziness; Feeling hot; Flushing; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0211311	10/29/2003	MO	55.0	55		F	10/29/2003	Rt. arm sore and range of motion was linited. Arm was throbbing.									U	10/10/2003	10/20/2003	10		UNK	UNK						1						1	Joint range of motion decreased; Pain	FLU3~EVANS VACCINES~765876~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211312	10/29/2003	GA	67.0	67		F	10/24/2003	Muscle weekness 1 hr. after injection. Next day went to ER. Temp: 103. c/o diarrhea,vomited x 1. Stated arm was red and deep purple from shoulder to elbow. Next day she went to PMD. Temp 102. Stated ER or PMD did not look at arm. They told her if it was a reaction that there was nothing they could do. Was given tylenol in ER.  Knot today the size of a jawbreaker. Patient called us 2 weeks after this occurred.				Y					Y	10/08/2003	10/08/2003	0	no	PUB	PVT	tylenol and diabetic meds daily, mv	no	fibromyalgia			1						1	Contusion; Diarrhoea; Erythema; Muscular weakness; Pyrexia; Vomiting	FLU3~EVANS VACCINES~765415~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0068n~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211314	10/29/2003	WA	0.0	54		F	10/29/2003	WITHIN 12 HOURS OF ADMINISTRTION, ONSET OF HEADACHE, MUSCLE ACHE AND FATIGUE. 36 HOURS AFTER ADMINISTRATION: SAME SYMPTOMS BUT LESS. 60 HOURS AFTER ADMINISTRATION: FATIGUE AND MUSCLE ACHE. aSPIRIN TAKEN X 4 A DAY FOR RELIEF. SYMPTOMS NOT SEVERE ENOUGH TO SEE PHYSICIAN.									Y	10/15/2003	10/16/2003	1		PUB	PUB			ALLERGIES: SULFA PENICILLIN			1						1	Fatigue; Headache; Myalgia	FLU3~EVANS VACCINES~765670~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211315	10/29/2003	AK	45.0	45		F	10/29/2003	TWENTY-FIVE HOURS AFTER ADMINISTRATION NOTED INJECTION SITE RED ITCHY WITH A BUMP UNDER THE SKIN. FIFTY TWO HOURS AFTER ADMINISTRATION VERY ITCHY AND BUMP BIG iMPROVED THE NEXT DAY AND RESOLVED THE DAY AFTER THAT.									Y	10/23/2003	10/24/2003	1		PUB	PUB						1						1	Injection site erythema; Injection site hypersensitivity; Injection site mass; Pruritus	FLU3~EVANS VACCINES~765670~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211316	10/29/2003	MA	3.0	55		F	10/29/2003	Hives, itching around site of the shot									Y	10/27/2003	10/28/2003	1		UNK	UNK						1						1	Injection site hypersensitivity; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211322	10/29/2003	MO	52.0	52		F	10/29/2003	I had the shot given 10-23-03 in the evening. Broke out in rash 10-25-03,itching was minimum other than under arms and scalp it like to have drove me crazy.I used Gold Bond Medicated Anti-itch Cream to help easy the itch,still itching some.But is beginning to clear up.I can't afford to go to doctor for just a rash.									Y	10/23/2003	10/25/2003	2		PUB	UNK		None	(penicillin)And any medicine of the same type.			1						1	Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211323	10/29/2003	TX	4.0	4		M	10/29/2003	pt. left office- returned within 3 minutes s.o.b., coughing, facial swelling, hives, bp: 90/50 hr:140's O2 stat:98 pt. was given benadryl 15mg IM and EMS was called.  Pt. was taken to hospital where he stayed for 4-5 hrs for observation. The follow up received on 11/3/03 states upper chest edema, no admission, reaction to flu. Medical records state sleepy. msv				Y	Y				Y	09/30/2003	09/30/2003	0		UNK	UNK		none	nkda			1						1	Cough; Dyspnoea; Face oedema; Pulmonary oedema; Somnolence; Urticaria	DTAP~SANOFI PASTEUR~uo997ca~5~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~w1156~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~w1095~4~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0097n~2~IM~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Hospitalisation	Influenza
0211324	10/29/2003	TX	5.0	5		M	10/29/2003	PT. WAS GIVEN FLU VACCINE LEFT OFFICE- MOM CALLED APPROX. 15MIN LATER STATING PT WAS HAVING FACIAL SWELLING- MOM DENIED SOB, DROOLING, FEELING FEARFUL.  ADVISED MOM TO RTO UNLESS PT HAD SOB OR WORSENED THEN SHE WOULD GO TO ER.  PT RTO AND PRESENTED WITH FACIAL SWELLING MAINLY AROUND THE EYES.  DR. EXAMINED PT- THEN PT WAS GIVEN BENADRYL 15 MG IM.  PT WAITED IN OFFICE FOR 30 MIN AND THEN WAS ALLOWED TO LEAVE.				Y					Y	10/28/2003	10/28/2003	0		UNK	UNK		NONE	NKDA			1						1	Swelling face	FLU3~SANOFI PASTEUR~U1095AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210124	10/30/2003		37.0			F	10/06/2003	Rash, swelling of throat, swallowing difficulty, swelling in arms.			Y						U		10/06/2003			UNK	UNK						1						3	Hypoaesthesia; Injection site oedema; Pain; Paraesthesia; Respiratory distress; Dyspnoea; Oedema peripheral; Pain; Dysphagia; Laryngeal oedema; Oedema peripheral; Rash	FLU3~SANOFI PASTEUR~U1268AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U12688A~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Life Threatening	Influenza
0211270	10/30/2003		75.0			M		A report was received from a state department immunization co-ordination on 10/20/03 concerning a 75 year old male vaccinee who experienced respiratory failure and was hospitalized an unspecified length of time after receiving Fluvirin on an unspecified date. The vaccinee has a history of chronic obstructive pulmonary disease and cardiac failure. On an unspecified date the vaccinee experienced respiratory failure. The outcome of the event was unknown at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.					Y				U					UNK	UNK			Chronic obstructive pulmonary disease and cardiac failure		PJP200300835	1						1	Respiratory failure	FLU3~EVANS VACCINES~765496~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0211271	10/30/2003		39.0	39		F		A report was received from a consumer on 10/22/03 concerning a 39 year old female vaccinee who experienced Guillain-Barre syndrome requiring hospitalization, with nausea, weakness of the arms and legs with difficulty controlling her muscles, and difficulty speaking 3 days after receiving fluvirin on 10/9/01. On 10/12/01 the vaccinee felt sick and her arms and legs became weak and she had difficulty controlling her muscles. By 10/26/01 the vaccinee was completely paralyzed and she was hospitalized. She was admitted to hospital and was diagnosed with Guillain Barre syndrome. During the 17 days in hospital the vaccinee received two and a half weeks of inpatient rehabilitation, with another 7 months outpatient rehabilitation. The vaccinee has not recovered and she still has residual effects of the Guillain Barre syndrome including difficulty speaking. No follow-up. Permission not granted to contact physician.					Y				U	10/09/2001	10/12/2001	3		UNK	UNK					PJP200300859	1						1	Guillain-Barre syndrome; Muscular weakness; Nausea; Paralysis; Speech disorder	FLU3~EVANS VACCINES~E04861KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0211274	10/30/2003	PA	8.0	8		F	10/28/2003	10/23/03 9 PM crying with discomfort. 10/24/03 Fever 100.4 PO; increased discomfort; 25 cent size redness at site, right arm. Redness and fever increased. Seen in ER and admitted. Temp 104 for 48hours. Erythema increased to 20cmx15cm size, warm, tender, decreased ROM. The discharge summary states pain, inflammatory swelling, nausea, and vomiting.					Y	4			Y	10/23/2003	10/23/2003	0	Lab test abnormal.	PVT	PVT	Flovent	NONE	Asthma			1						1	Crying; Discomfort; Injection site erythema; Injection site pain; Injection site warmth; Joint range of motion decreased; Laboratory test abnormal; Nausea; Pyrexia; Vomiting	FLU3~EVANS VACCINES~765664~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0740N~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0211275	10/30/2003	NY	94.0	94		F	10/03/2003	Patient developed stridor, laryngeal edema, myocardial infarction, within 24 hours after receiving influenza vaccine. The medical record received on 1/23/04 states stress and reaction to flu vax. The 60 day follow up received on 01/13/04 states pt experienced MI following vaccination. She is 94 y/o although I do not have further info it is unlikely she completely recovered from this event.			Y		Y				U	10/01/2003	10/02/2003	1	10/02/03 CKMB 7.7; Troponin 0.84; Lab test abnormal, EEC abnomal	UNK	UNK			Rib fx, compression fx of spine, anxiety.			1						1	Anxiety; Electrocardiogram abnormal; Laboratory test abnormal; Laryngeal oedema; Myocardial infarction; Stridor	FLU3~SANOFI PASTEUR~U1081AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0211277	10/30/2003	GA	50.0	50		F		Left deltoid red and warm to touch. Pt evaluated by MD.									Y	10/15/2003	10/17/2003	2		PVT	UNK		NONE	IVP dye, codeine			1						1	Feeling hot; Injection site erythema	FLU3~EVANS VACCINES~765495~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211278	10/30/2003	PA	26.0	26		F	10/24/2003	55mm x 45mm raised erythemic localized reaction, hot to touch noted 2 days post vaccine (to left deltoid area). Adv: Advil, cool compresses, report reaction to PMD. C/o itching but no pain at site. Gone in 5 days.									Y	10/22/2003	10/23/2003	1	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Injection site warmth; Pruritus; Rash erythematous	FLU3~EVANS VACCINES~765485~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211279	10/30/2003	MI	20.0	21		F	10/22/2003	At injection site, 2 diameter reddened area, warm to touch. C/o tenderness right injection site with hard lump at vaccine site cluster, warm to touch. 10/27/03: redness, itching entirely gone now.				Y					Y	10/20/2003	10/21/2003	1		PVT	PVT	Lortab, Zovarax	NONE	Latex powder			1						1	Feeling hot; Injection site erythema; Injection site mass; Pain; Pruritus	FLU3~SANOFI PASTEUR~765876~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211280	10/30/2003	CA	70.0	70		F	10/21/2003	Pt is 70 years old. She received an influenza vaccine and pneumococcal vaccine on 10/11/2003 at drug store. Flu vac in right arm; pneumovac left arm. Within 6-8 hours pt developed fever to 100 degrees. swelling of right upper extrem extending to right neck and right anterior chest wall. She was seen in ER 10/12/03 and treated with Dicloxacillin for cellulitis. The timing does not fit occurrence of cellulitis. ?Significant local reaction to flu vac.				Y					U	10/11/2003	10/11/2003	0		UNK	UNK	NONE		No egg allergy. Has gotten annual flu vac. Had previous pneumovac 1/99. No meds. No injuries to UE.			1						1	Cellulitis; Oedema; Pyrexia	FLU3~SANOFI PASTEUR~1256AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0253N~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211281	10/30/2003	RI	23.0	23		F	10/22/2003	Flu shot was received from clinic on the afternoon of 10/21/2003. Upon arising the next morning, the pt had a headache, had decreased ROM in arm where shot was administered, pain, erythema, and edema around site of injection. This was reported to be worse than other flu shots that had been received in the past.									U	10/21/2003	10/22/2003	1		UNK	UNK	Ortho Tri Cyclen, Fastin		Asthma, fatigue. Allergies: grass, cats, sulfa medications, strawberries, Oxi-Clean			1						1	Headache; Injection site erythema; Injection site oedema; Joint range of motion decreased; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211282	10/30/2003	FL	43.0	40		U	10/24/2003	We are using Aventis flu vaccine, Fluzone, Lot #U1127AA administered by employee health nurse caused extreme burning and pain. Many patients swell with heat coming off it. Some patients had welts and streaking. Called company.									U	10/21/2003	10/21/2003	0		UNK	UNK						1						1	Injection site oedema; Injection site warmth; Pain; Thermal burn; Urticaria	FLU3~SANOFI PASTEUR~U1127AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211283	10/30/2003	TN	65.0	65		F	10/18/2003	Pt received vaccination on 10/08/03 and on 10/09/03. Pt experienced swelling above (on arm vaccinated) elbow region and radiating toward (vaccinated arm) to wrist.				Y					Y	10/08/2003	10/12/2003	4	Ultrasound - unremarkable	OTH	OTH	Premarin, Lisinopril, hydrochlorotenazide, Synthroid, Lipitor		Hemophilia, hypertension, hypercholesterolemia			1						1	Injection site oedema	FLU3~SANOFI PASTEUR~U1074AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211284	10/30/2003	IL	65.0	65		F	10/30/2003	Right upper extremity swelling, redness, tenderness, swelling at injection site. Consistent with cellulitis.				Y					Y	10/18/2003	10/29/2003	11	Xray - no soft tissue air	PVT	OTH	Rispernel, Premarin	NONE	HTN, shingles 1998			1						1	Cellulitis; Injection site erythema; Injection site oedema; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0211285	10/30/2003	NH	53.0	53		F	10/29/2003	3 hours after administration complained of head stuffiness, dry cough, and nasal congestion and drainage.									N	10/27/2003	10/27/2003	0	NONE	PUB	OTH	NONE	NONE	NONE			1						1	Cough; Nasal congestion	FLU3~EVANS VACCINES~765798~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211287	10/30/2003	GA	24.0	24		F	10/29/2003	Pt has Rheumatoid Arthritis and Lupus and is on several meds, including Avara, Methotrexate, Leucororan, Placueril, Prednisone. Pt given Pneumovax on right deltoid. Had some soreness and nodules develop, in right deltoid area only, about 24 hours later. Seen in office 2 days after injection. Right deltoid region had <7 tender papules, suggestive of erythema nodosum. Pt given darvocet prn pain.									U	10/21/2003	10/22/2003	1		PVT	PVT	Avara, MTX, Leucororan, Prednisone, Placquenil, Actonel, folic acid, Ortho Tri Cyclen	NONE	Allergy to PCN; RA, SLE			1						1	Erythema nodosum; Injection site nodule; Pain	FLU3~EVANS VACCINES~765178~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211288	10/30/2003	MI	42.0	42		F	10/20/2003	Wheezing after 45 minutes administration, continued shortness of breath and dizziness after 10/15/03.				Y					Y	10/15/2003	10/15/2003	0	Xrays, Pulse ox	PUB	OTH		NONE	Asthma			1						1	Dizziness; Dyspnoea; Wheezing	FLU3~SANOFI PASTEUR~U1287AA~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211289	10/30/2003	NY	31.0	31		M	10/24/2003	Swollen, painful glands/neck area lasting over 1 week. Flu-like symptoms (lethargy, chest pain, uneasy breathing). Tuesday evening the pain was so bad, I took 50 mg Vioxx and 20 mg Ambien to fall asleep.									N	10/17/2003	10/21/2003	4		OTH	PVT						1						1	Chest pain; Dyspnoea; Influenza like illness; Lethargy; Lymphadenopathy; Pain	FLU3~EVANS VACCINES~765667~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211299	10/30/2003	IL				F	09/16/2003	Information regarding influenza virus vaccine (manufacturer unknown) was received from a consumer regarding a female patient who experienced symptoms of a head cold with a runny nose and nasal congestion.  The patient received a dose of an unspecified date in 2001.  No additional information was available at the date of this report.									U				UNK	OTH	OTH	UNK	UNK	UNK	head cold with a runny nose and nasal congestion following receipt of a flu vaccine on a unspecified date in 2002.  See HQWYE5	HQWYE584309SEP03	1						1	Malaise; Nasal congestion; Rhinorrhoea	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0211300	10/30/2003	IL	50.0			F	09/16/2003	Information regarding influenza virus vaccine (manufacturer unknown) was received from a consumer regarding a 50 year old female patient who experienced symptoms of a head cold with a runny nose and nasal congestion.  The patient received a dose on an unspecified date in 2002.  No additional information was available at the date of this report.									U				UNK	OTH	OTH	UNK	UNK	UNK	Head cold with a runny nose and nasal congestion following receipt of a~Influenza (Seasonal) (no brand name)~~0.00~In Patient	HQWYE521605SEP03	1						1	Malaise; Nasal congestion; Rhinorrhoea	FLU3~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0211334	10/30/2003	PA	53.0	53		F	10/28/2003	Flu vaccine given at 0900. Pt states at 1900 developed rapid pulserate of 100, developed body aches. Went to bed with pulse of 100, when Patient awoke the following morning pulse was normal.									Y	10/26/2003	10/26/2003	0	n/a	UNK	PVT		none	none			1						1	Heart rate increased; Pain	FLU3~SANOFI PASTEUR~u1123aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211335	10/30/2003	KY	45.0	45		F	10/29/2003	HIVES; SWELLING; HOT TO TOUCH; PAIN FROM NECK TO HAND; ITCHING  TREATMENT: ANTIHISTAMINES									Y	10/28/2003	10/28/2003	0		UNK	PVT	CELEXA,ALLEGRA,ARMOUR THYROID	NONE	HYPOTHYROID, MILD DEPRESSION, SEASONAL ALLERGIES, THORACIC OUTLET SYNDROME AFFECTING LEFT ARM AND NECK			1						1	Injection site swelling; Injection site warmth; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1079AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211336	10/30/2003	MS	66.0	66		F	10/28/2003	Lt forearmarea red swollen and sore 10/17/03.  Worse on 10/18/03 had to go to ER given antibiotic injection and rx for anitbiotics for cellulitis, benedryl no reaction at injection site.				Y					Y	10/16/2003	10/17/2003	1	none	UNK	UNK						1						1	Cellulitis; Erythema; Pain; Swelling	FLU3~SANOFI PASTEUR~U1094AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1026M~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211338	10/30/2003	NC	37.0	37		M	10/30/2003	History of Present Illness:  Patient was admitted to hospital on 20 October 2003 with a diagnosis of rhabdomyolysis.  Consulted the HC as this patient had received several vaccinations on 16 October 2003. Medical record states nausea.   Anthrax #1 Hep B #1 Hep A #2 Influenza IPV MMR TD PPD Typhoid Smallpox 16 Oct 2003 Received immunizations on this date.  No problems except the patient states he had had a cold for about a week.  Of note, he had undergone a tooth extraction on the previous day 14 Oct 2003 and was taking Tylenol #3 for pain (one every 4-6 hours prn pain #15). 20 Oct 2003 Patient reports that he participated in PT that morning as usual.  He ran 2 miles and did approximately 20 push-ups.  After this he went to work, and after lunch, he noted muscle pain in bilateral upper extremities.  He experienced stomach cramps, and when he got up to go to the restroom, he began feeling dizzy.  He also noted that his urine was dark brown.  A co-worker later took him to the emergency room, and he was admitted with a diagnosis of rhabdomyolysis. He reports no significant increase in exercise recently-just the typical required PT (running 2 miles/day and push-ups/sit-ups).  He believes that he kept himself adequately hydrated.  No report of excessive alcohol intake.  He had 3 ½ beers the night prior to his admission.  No illegal drug use.  He reports a past use of creatine supplements but states that he has not taken creatine since May 2003.  He is concerned that the water he has been drinking may have contributed to his illness as he was told by some medics that the water was contaminated and that they should not be drinking it. 22 Oct 2003 Patient enrolled in HC services and history obtained.  Reports that he is feeling better.  The muscle pain in bilateral upper extremities is improving.  Abdominal cramping has resolved.  No shortness of breath or chest pain.  Patient does note that he was experiencing pain throughout his upper chest, neck, and back initially, but this has resolved with the exception of back pain, which he attributes to the hospital bed.  No pain in lower extremities. 23 Oct 2003 Follow-up visit conducted with patient while still hospitalized.  Reports that he is slowly starting to feel better.  However, his laboratory results continue to show elevated CK, LFTs, and myoglobin. 27 Oct 2003 Phone call to follow-up with patient.  He reports no further muscle pain but continues to feel more tired and weak than usual.  I'm at 50% of my usual.  Will be discharged this afternoon.  CK, LFT, and myoglobin values have decreased and will be rechecked tomorrow.				Y	Y	7			U	10/16/2003	10/20/2003	4	Laboratory Data:   Date CK (22-269) CK-MB (2.3-9.5) Relative Index (0-2.5) Troponin I(0-1.5) 10/28/03 3869 H 30.9 H 0.8 Medical records state lab test abnormal, CK increased, hypocalemia, ASPT increased.  10/27/03 6445 H 67.4 H 1.0  10/26/03 9806 H 91.6 H 0.9  10/25/03 @ 0955 21617 H 172.8 H 0.8  10/25/03 @ 0543 2193 H 23.7 H 1.1  10/24/03 @0615 49278 H 711.2 H 1.4 <0.07 10/23/03 @2320 3764 H 113.7 H 3.0 H <0.07 10/23/03 @1049 78355 H 581.1 H 0.7  10/22/03 @ 1630 96990 H 1169.2 H 1.2 <0.07 10/22/03 @ 0615 111909 H 763.3 H 0.7  10/21/03 @ 0700 66840 H 490.0 H 0.7 <0.07 10/21/03 @ 0119 3365 H 837.8 H 24.9 H   Chemistry: 10/25/03:  WNL except BUN < 5 (9-20), CA 8.4 L (9.0-10.5), MG 1.6 L (1.8-2.5) 10/24/03:  WNL except BUN < 5 (9-20), CA 8.7 L (9.0-10.5), MG 1.7 L (1.8-2.5) 10/23/03:  WNL except BUN < 5 (9-20), CA 8.5 L (9.0-10.5), MG 1.6 L (1.8-2.5) 10/22/03:  WNL except  NA 135 L (136-145), BUN <7 (9-20), CA 8.2 L (9.0-10.5), MG 1.6 L (1.8-2.5) 10/21/03:  WNL except K 3.3 L (3.6-5.0), BUN 8 L, CA 8.7 L  CBC: 10/25/03:  WBC 3.7 L (4.4-11.0), RBC 3.96 L (4.4-5.9), HGB 12.4 L (13.0-17.2), HCT 36.3 (39-52), Platelets 159 (142-424), Neut # 1.8 L (2.0-6.9) 10/24/03:  WBC 4.1 L, RBC 4.16 L, HGB 13.4, HCT 38.2 L, Platelets 171 10/24/03:  WBC 6.1, RBC 4.17 L, HGB 13.6, HCT 38.6 L, Platelets 163 10/21/03:  WNL  Liver Function: 10/25/03:  AST 353 H (10-42), T BILI 1.1 (0.2-1.0), ALT 198 H (7-47), Total Protein 5.3 L (6.4-8.0), Albumin 2.8 L (3.2-4.9) 10/24/03:  AST 597 H, T BILI 1.2, ALT 249 H, Total Protein 5.36 L, Albumin 3.1 L  10/23/03:  AST 775 H, T BILI 1.2 H, ALT 262 H, Total Protein 5.4 L, Albumin 2.8 L 10/22/03:  AST 829 H, T BILI 1.0, ALT 244 H, Total Protein 5.7 L, Albumin 2.9 L 10/21/03:  AST 582 H, T BILI 2.0, ALT 164 H, Total Protein 6.0 L, Albumin 2.9 L  Uric Acid:  10/22/03:  5.7 (2.6-7.2)          10/21/03:  7.7 H   Sickle Cell Screen:  10/22/03:  Negative  Myoglobin:  10/25/03:  261.42 H (0-110)   10/24/03:  488.24 H   10/23/03:  952.20 H   10/22/03:  3560.33 H  G-Globulin:  10/21/03:  5.4 UPE Albumin FRA 10/21/03:  21.6 % A1-FRACT UPE 10/21/03:  4.0% A2-FRACT UPE 10/21/03:  10.7% B-FRACT UPE 10/21/03:  58.3%  G6PD   10/21/03:  Normal  Amylase:   10/25/03:  52 (20-120)   10/23/03:  69   10/21/03:  100  Lipase:   10/25/03:  25 (7-58)   10/24/03:  27   10/23/03:  24   10/21/03:  25  TSH:  10/21/03:  1.97 (0.35-5.50)  C Reactive Protein:  1.2 (0.0-2.2)  U/A:  10/22/03:  WNL except 250/UL Blood           10/21/03:  2 + Protein, Trace Ketones, 1 mg/dl urobilinogen, 250/ ul Blood                 Urine Drug Screen:  10/21/03:  Negative for amphetamines, barbiturates, benzodiazapines, THC, cocaine, phencyclidine   Positive for opiates.  Urine Quantitative  UR Myoglobin 10/21/03:  603 H Medical record states increase in CKMB, CK increased, hypocalemia, ASPT increased.	MIL	MIL	Medications: oNone oHe had taken Tylenol #3 after his tooth extraction.  Complementary & Alternative Medicine Use: oPast use of a multi-vitamin and creatine supplement-but denies use since May 2003.	None Medical record states pharyngitis.	None			1						1	Abdominal pain; Back pain; Blood alkaline phosphatase increased; Blood creatine phosphokinase increased; Chest pain; Chromaturia; Dizziness; Hypocalcaemia; Laboratory test abnormal; Myalgia; Nausea; Neck pain; Rhabdomyolysis	ANTH~EMERGENT BIOSOLUTIONS~~1~SC~UN~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~5444A4~1~IM~UN~HEP B (NO BRAND NAME)~1|HEPA~MERCK & CO. INC.~0065N~2~IM~UN~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~U0460~1~SC~UN~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0970M~1~SC~UN~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|SMALL~PFIZER\WYETH~~1~ID~LA~SMALLPOX (DRYVAX)~1|TD~SANOFI PASTEUR~U0829AA~1~IM~UN~TD ADSORBED (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0211342	10/30/2003	CA	50.0	50		M	10/30/2003	nausea, vomiting, fever, red skin									U	10/28/2003	10/28/2003	0		MIL	UNK	baclofen, nifedipine, percocet	none	allergy to Levaquin. h/o low back pain, GERD			1						1	Erythema; Nausea; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211347	10/30/2003	MO	11.0	11		M	10/24/2003	hands started burning, itching, peeling.  Reddness spots around arm.  Sat. AM started having asthma signs and mom startied albuterol inhaler.  This continued through the day.  By Sunday peeling spread to knees and reached feet, by Monday toes.  Full asthma attack Tuesday night at hospital.  Wed diarehea, vomiting. Continued until Friday 10-24-03.				Y					Y	10/17/2003	10/17/2003	0		UNK	UNK	none	none	dx with strep 10-10-03, dx 2000 allergy to nickel and themerisol (parents forgot)		MO200389	1						1	Asthma; Diarrhoea; Erythema; Pruritus; Skin exfoliation; Vomiting	FLU3~EVANS VACCINES~765854~1~ID~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0211348	10/30/2003	CA	55.0	55		F	10/30/2003	(Inactivated Influenza) Vaccine administered at 1:00pm, at 2:00am the following morning I suffered from stomach cramps and vomitting (although limited since my stomach was empty). The following day I was dizzy and weak with stomach ache.									Y	10/29/2003	10/30/2003	1		UNK	UNK	Prevacid, Tramadol		acid reflux and fibromyalgia allergies to some foods and weeds			1						1	Abdominal pain; Abdominal pain upper; Asthenia; Dizziness; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211349	10/30/2003	MD	0.0	71		M	10/30/2003	swollen right wrist									Y	10/28/2003	10/30/2003	2		UNK	UNK						1						1	Swelling	FLU3~SANOFI PASTEUR~U1271AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211326	10/31/2003	WA	81.0	81		M		This subject is an 81 year old male who according to his wife was admitted to the hospital due to an acute myocardial infarct while enrolled in the RSV 11 study. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/17/02. Subject was admitted to the hospital 284 days post immunization and died 13 days later. Investigator has requested a discharge summary. The myocardial infarction was reported by the investigators as not related to the study vaccine. The death certificate received on 11/20/03 states cardiomyopathy. Follow up on 11/26/03:  Additional information received 11/18/03.  Death Certificate: Date of death: 08/10/03.  Cause of death: PEA arrest due to Global Dilated Cardiomyopathy.  The PEA arrest secondary to Global Dilated Cardiomyoptahy was reported by the Investigator as not related to the study vaccine.	Y	08/10/2003			Y	13			N	10/17/2002	07/28/2003	284	Information received from previous hospitalization 11/25/02-11/28/02: The subject developed back and shoulder pain, 36 days post-immunization and 3 days prior to admission into hospital.  The pain increased and became associated with chest pressure and radiation of pain down his left arm. NTG did not relieve the pain.  Subject did not want to go to the hospital until the evening of 11/25/02 when pain became very severe with associated nausea.  He was admitted to hospital on 11/25/02 and started on NTG gtt, morphine and b-blocker and when stabilized was transferred to another hospital.  At transfer subject was pain free, enzymes were essentially negative and EKG had no new changes.  He was unable to tolerate a nuclear stress test secondary to claustrophobia.  Physical exam was within normal limits except for decreased breath sounds at lung bases.  Renal U/S showed no hydronephrosis or renal calculi w/in either kidney with mild parenchymal thinning.  Initial troponin was 0.1.  ECG showed RBBB with ST seg depression in V1 and V2, left axis deviation and sinus tachycardia.  Chest x-ray showed cardomegaly with no infiltrates.  Reported labs were HCT 31.8, platelets 203, creatinine 3.2, BUN 43, CPK 101, CKMB 4.6, and troponin 0.15.  Creatinine increased from 3.2 to 3.5.  Urine protein/creatinine ratio and renal U/S were both obtained and were normal.  Subject was started on ASA and continued on digoxin, dilitiazem and started low dose of carvedilol and continued on outpt inhalers for severe COPD based on PFT's.  UTI was diagnosed by U/A with >30 WBC HPF and treated w/ Levofloxacin.  A sudden onset of pain and swelling on the lateral left ankle was treated with Tylenol.  He was discharged home w/diagnosis of atypical chest pain in setting of known CAD on ASA and b-blocker.  Symptoms/Diagnosis: Chest pain, intermittent A-fib, CHR class II-III, Acute Renal Failure, UTI.  The subject recovered.  He has a follow up appointment with cardiology in 1-2 months.  Information received from previous hospitalization 05/05-08/03.  Subject was hospitalized 200 days post immunization for diaphoresis, with chest pressure, palpitations, nausea, diaphoresis, tachycardia.  He has had difficulty with variable heart rates in a fib/flutter/jxnal since 04/03. On digoxin/carvedilol for a fib rate control and heart failure.  Developed bradycardia with apparent accelerated jxnal rhythm when seen in clinic by doctor on 04/10/03.  He has been off and on his digoxin and carvedilol since, with alternating episodes of tachycardia and bradycardia.  Stopped Digoxin 04/27/03.  Continued on carvedilol 3.125 mg bid.  Plan for OP permanent pacer to treat bradycardia assoc with tx of atrial tachycardia.  EKG-aflutter, rate about 150, extreme LAD, RBBB, info Q, Q V3-4 after 10 mg Diltiazem-rate 102, freq PVC's o/w unchanged.  CxR 05/05-Although the left lung base was excluded in the image, there may by opacity obscuring left hemidiaphragm possibly atelectasis or pneumonia. Cardiomegaly unchanged w/out sign of interstitial edema.  05/06-Cardiomegaly and pulmonary vascular engorgement w/out overt failure.  New cardiac pacer in satisfactory position.  05/07-PA/LAT-continued satisfactorypostoperative appearance following single-lead left transvenous pacemaker placement, w/pacemaker components in customary position.  No pneumothorax of other complication is seen, and no change observed from yesterday's film  Moderate to severe cardiomegaly is again noted, w/out evidence of CHF.  Hospital course: 1) Tachy/Brady Syndrome: patient admitted to tele for monitoring and rate control. Diltiazem boluses brought rate from 140s to 90s readily.  Initially increased long acting Diltiazem to 240mg qd from 180mg qd in rsponse.  Also increased Carvedilol from 3.125 mg bid to 6.125 mg bid.  However, patient became relatively hypotensive on these med increases with SBP 80s-90s on hosp day #2.  Thus decreased back to OP doses of Carvedilol and Diltiazem and restarted Digoxin with IV load as rate had been in 40s as OP on this regimen.  Subject received pacemaker on 05/06/03 w/out complication.  Pacing appropriately below rates of 70.  2) NSTEMI-patient admitted with CP assoc w/tachycardia.  Had small bump in troponin to 0.43 from baseline of 0.18 or so.  Experienced no further CP in house.  Thought that small NSTEMI was rate related.  Patient was continued on CAD risk modification meds, including ASA, Carvedilol, Losartan.  Patient rqstd to PharmD on d/c that ASA be discontinued.  3) Ischemic Cardiomyopathy-EF 35-40% 04/01.  No signs of volume overload on CxR or exam and osygenation fine, thus diuresis was not pursued.  CO likely worsened by tachycardia, causing worsening renal function and acidosis, but improved with rate control.  Continued Losartan, Carvedilol, ASA, Lasix 40mg qd restarted on d/c.  4) Renal failure-Experienced worsening of Cr from recent baseline of 2.8-2.9 to 3.7 recently, likely due to tachycardia resulting in worsened cardiac output. Decreased to and stabilized at 3.1 on discharge.  Following with Renal as outpatient to determine when and whether to start dialysis. Continued on Losartan.  5) Gap metabolic acidosis-subject presented with bicarb of 18 and AG 16, resolved over hospital stay.  Presumed due to decreased CO and lactic acidosis and better now that rate is better controlled  Bicarb 24 on d/c.	UNK	UNK			Trachy Brady Syndrome; A-fib; CAD; CHF; COPD; Sprain; Actinic Keratosis; Gastroesophageal Reflux Disorder; Colonic Polyps; Iron Deficiency Anemia; Obstructive Lung Disease; Hypertension; Glaucoma; Cataract; Hypothyroidism; Renal insufficiency; Anticoagulation assoc bleeding; Allergy;		200302677	1						1	Cardiomyopathy; Myocardial infarction	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0211356	10/31/2003	NJ	56.0	56		F	10/24/2003	It was reported that a 56 year old female pt received a dose of Fluzone SV '2003-'2004, lot #U1135EA, administered IM in the left deltoid on 10/15/03. Two days later, the pt developed rash on her back, arms and torso for which she took Benadryl and steroids. On 10/19/03, the pt was admitted to the ER due to generalized rash, for which she was given Zyrtec, Prednisone, and Rantidine and then discharged. The following day, the pt reported bilateral leg swelling and was hospitalized the next day due to persistent symptoms and remains hospitalized. Reportedly, the pt is vaccinated with the flu shot every year. Due to previous cellulitis of the legs 10/2/03, cause dby insect bites, the pt was recently treated with 500mg of Duricef.  Follow up on 11/17/2003: From additional information received through a telephone call on 11/10/2003 from the primary reporter, the patient's primary physician's information was reported.  The reporter indicated that all the information available has been provided.  A call was made to patient's primary physician, who was out of the office that day.  The secretary provided the patient's full name and correct physician information, as well as the fax number for the office.  No additional information was given at this time. From additional information received on 17/Jan/2004 from a physician, it was reported that the case was reviewed and there is no additional information at this time. Further information is not anticipated, this case is considered closed. Follow up 01/06/05: Medical assessment: There were no investigations reported. The amount of availabe data is not sufficient to readly assess the case. In the absence of another etiology, the hypothesis that skin eruption and leg swelling correspond to clinical manifestations of a serum sickness like reaction after administration of cefadroxil or due to insect venom could be evoked.					Y				U	10/15/2003	10/17/2003	2	UNK	UNK	UNK		NONE	Sulfa allergy-previous history of cellulitis of legs due to insect bites 10/2/03. Treated with Duricef.		200302694	1						1	Oedema peripheral; Rash	FLU3~SANOFI PASTEUR~U1135EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0211357	10/31/2003	FL	7.0	7		M	10/24/2003	Seizure (partial complex) occurred approximately 5 hours after immunization. Off and on seizure for 2 hours; active seizure witnessed by physician. Patient has known seizure disorder/developmental delay.				Y	Y				Y	10/23/2003	10/23/2003	0	EEG-abnormal	PVT	PVT	Topamax	NONE	Developmental Delay; Seizure Disorder; Microcephaly; GERD; G-Tube feeds, cerebral palsy.			1						1	Convulsion; Electroencephalogram abnormal	FLU3~SANOFI PASTEUR~U1097AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~493475~1~IM~LA~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0211359	10/31/2003	AK	58.0	58		M	10/29/2003	Patient received Amevive from MD, for psoriasis AM of 10/28/2003 (IV).  Also had external Oxsoralen ultra treatment that AM (10th or 11th Amevive tx).  Had flu shot about 2-3 hours later.  Approximately 14:00 on 10/28, experienced itching.  When patient got home from work about 17:00, noted hives on legs, trunk, arms and groin.  Felt nervous and took Benadryl x 1 at 18:00.  Minor relief and repeated Benadryl at 21:30.  Slept OK, and reported to our office at about 08:20 10/29/2003.  Currently only feels drugged and head pressure.									Y	10/28/2003	10/28/2003	0	NONE	PVT	PUB	Amevive IV; Oxsoralan Ultra	NONE	Psoriasis			1						1	Headache; Pruritus; Sedation; Urticaria	FLU3~SANOFI PASTEUR~U1271AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211360	10/31/2003	NY	28.0	28		F	10/30/2003	Severe periorbital edema, pruritis, mild facial edema.  Onset approximately 15 hours after vaccination.  Patient instructed by provider to take Benadryl 25mg every 6 hours as needed.  Symptoms subsiding.									Y	10/28/2003	10/29/2003	1	NONE	PVT	PUB	Depoprovera injection; Combivent inhaler	NONE	NONE			1						1	Face oedema; Periorbital oedema; Pruritus	FLU3~SANOFI PASTEUR~U1068AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211361	10/31/2003	CA	77.0	77		M	10/30/2003	Erythema upper and lower arm (left).									Y	10/28/2003	10/29/2003	1	NONE	PVT	PVT	NONE	NONE	Asthma, Chronic obstructive pulmonary disorder			1						1	Erythema	FLU3~EVANS VACCINES~765873~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0947N~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211362	10/31/2003	WA	68.0	68		F	10/30/2003	Administered both vaccines 10/21/2003.  Burned at time of injection. 10/22/2003: Arm swelling/hot/lack of sleep; 10/23/2003: Area shouting red streaks.  Visit to MD, given Clarinex.  Since then, patient has felt very nauseous, severe headache, while body aches and heartburn with is worse today.				Y					U	10/21/2003	10/21/2003	0	NONE	OTH	PVT	NONE	NONE	Previous reaction to Td at 14 years old?			1						1	Cellulitis; Dyspepsia; Headache; Injection site oedema; Injection site warmth; Insomnia; Nausea; Pain; Skin burning sensation	FLU3~SANOFI PASTEUR~U1256AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0564N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211363	10/31/2003	IN	41.0	41		F	10/30/2003	Received IM flu vaccine at 10:00 approximately 1.5 hours later, began itching took Benadryl per mouth.  Approximately 15-20 minutes later, vision blurred, legs weak, layed down on floor.  Transported to ER, received solumedrol IV.				Y					Y	10/29/2003	10/29/2003	0	CBC and CMP	PVT	PVT	NONE	NONE	Hypothyroidism			1						1	Muscular weakness; Pruritus; Vision blurred	FLU3~SANOFI PASTEUR~U1099AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211364	10/31/2003	VA	12.0	12		F	10/29/2003	Patient had chills, fever, nausea, headache.  Patient to take Benadryl 25mg 3 times a day for 1 day then as needed.				Y					Y	10/28/2003	10/28/2003	0	WBC: Decreased; Rest of CBC: Normal comprehensive metabolic panel: normal;	PVT	PVT	NONE	NONE	Peanut allergy			1						1	Headache; Nausea; Pyrexia; White blood cell count decreased	FLU3~SANOFI PASTEUR~U1088AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211365	10/31/2003	TX	57.0	57		F	10/03/2003	Dizziness, Palpatations, severe fatigue for 3 days.									Y	09/26/2003	09/26/2003	0	NONE	PUB	PUB	Tylenol 500mg as needed	NONE	Arthritis (2 weeks ago diagnosed)		TX03128	1						1	Dizziness; Fatigue; Palpitations	FLU3~SANOFI PASTEUR~U1140AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211366	10/31/2003	VA	9.0	9		F	10/27/2003	Approximately 4-5 minutes after receiving Fluzone vaccine, client fell and hit head on floor.  Client appeared to exhibit seizure-like activity (eyes rolling back of head, p?) for approximately 20 seconds.  After 20 seconds, client tried to focus eyes but could not.  EMS called and arrived in 5 minutes.  Speak coherently for 1-2 minutes.  Pulse 100, Respiratory 20.				Y					Y	10/27/2003	10/27/2003	0	UNK	OTH	PUB	Anaplex cough syrup	NONE	NONE			1						1	Convulsion; Eye movement disorder; Staring	FLUX~UNKNOWN MANUFACTURER~765793~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0211367	10/31/2003	GA	4.0	4		M	10/27/2003	Mother reports reaction from vaccine causing swelling, redness and rash to left upper arm requiring treatment by ER.  Prescribed Cephalexin 250mg 1.5 tsp twice a day for 10 days and Zyrtec syrup 1 tsp everday.				Y					Y	10/24/2003	10/26/2003	2	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Rash	DTAP~SANOFI PASTEUR~U0997BA~5~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1145AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W1582~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0130N~2~SC~RA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA	Emergency room visit	Influenza
0211368	10/31/2003	KY	66.0	65		F	10/21/2003	10/21/2003: Noticed right upper arm red, warm and swollen.  given decadron 10mg IM.  Better on 10/22/2003.				Y					Y	10/20/2003	10/21/2003	1	NONE	PVT	PVT	Premarin, Atenolol, Alprazalem, Syntroid, Enalapril, Relaten	NONE	NONE			1						1	Erythema; Feeling hot; Oedema	FLU3~EVANS VACCINES~765712~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0531N~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211369	10/31/2003	WI	1.5	1	.6	M	10/24/2003	On 10/23, patient had DTAP, MMR & Flu vaccine.  Mom called 10/24/2003 stating that left thigh was hard, red, and warm to touch.  Appointment made and seen by NP.  Left thigh 15 inch circumference area with edema, erythematous, firmness and warm to touch.  Right thigh 11.5 inch circumference same reaction.  Started on Zyrtec 1/1 2.5 mL per mouth every day.  Cephalexin 250/5 4mL.				Y					Y	10/23/2003	10/24/2003	1	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Feeling hot; Injection site erythema; Injection site induration; Injection site oedema	DTAP~SANOFI PASTEUR~C1387AA~4~~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1081AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0273N~1~~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA	Emergency room visit	Influenza
0211370	10/31/2003	CT	67.0	67		M	10/16/2003	Patient received pneumococcal vaccine 10/14/2003.  Following day developed fever, chills, severe pain from elbow to shoulder on affected arm.  Area extremely tender to touch.									Y	10/14/2003	10/15/2003	1	NONE	PUB	PUB	Diazepam	NONE	NONE			1						1	Injection site pain; Pain; Pyrexia	FLU3~EVANS VACCINES~765745~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0358M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211371	10/31/2003	CT	68.0	68		F	10/16/2003	Patient received Pneumococcal vaccine 10/14/2003.  Following morning developed severe pain in affected arm from elbow to shoulder.  Area very tender to touch.									Y	10/14/2003	10/15/2003	1	NONE	PUB	PUB	Vioxx	NONE	NONE			1						1	Injection site pain; Pain	FLU3~EVANS VACCINES~765745~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0358M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211372	10/31/2003	CT	81.0	81		M	10/28/2003	Received influenza 0.5mg IM left arm 10/21/2003.  On 10/26/2003 observed a non-itchy purple rash on left great toe left 2nd, 3rd toe, both legs extending to groin area, chest underneath both arms extending from wrist to elbows.  Notified MD.  No treatment at this time.  If not resolved in one week (11/03/2003) to see MD.  Has had flu vaccine annually with no ill effects. The follow up received on 11/11/03 states approximately five weeks ago, pt had tick bite on his right upper arm with a bull's eye rash which resolved without treatment. After receiving the flu vaccine on 10/21/03, his spouse noticed increased agitation while awake, but would readily fall asleep when sitting, loss of appetite and decreased interest in reading. He was seen by his dermatologist on 11/3/03 who diagnosed vasculitis and prescribed Cortisone cream 0.25% to the affected areas. On 11/4/03, pt was seen for a routine cardiology appointment and he was beginning to show signs of tremors and unsteady gait. He c/o chills and on 11/5/03 his T was 102 F. An appointment was made with his primary care physiican for 11/6/03. After being seen by his doctor, pt was admitted to hospital. Extensive blood work, neurology consult, leg lesion biopsy and medical consults have been done. He continues with unsteady gait and agitation.									N	10/21/2003	10/26/2003	5	NONE	PUB	PUB	Coumadin, ASA, Hyzaar, Lipitor, Imout, Tenormin, Zyloprim, Proscale, MVI	Hemochromatosis, Status post triple bypass	Bacitracin, Neomycin-Polygram, Lotmar eye drops			1						1	Agitation; Decreased appetite; Gait disturbance; Rash; Vasculitis	FLU3~SANOFI PASTEUR~U1102AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211373	10/31/2003	MA	64.0			F		Patient given pneumococcal vaccine polyvalent pneumovax 23 0.5cc sub cutaneously in left arm 10/23/2003.  Patient called 10/24/2003 AM to wake with left arm should be swollen and painful.  Nurse had patient come in for evaluation.  Fount 98.4 temperature.  Left arm swollen, painful, red and warm to touch.  Swelling left deltoid to pain upper arm.									Y	10/23/2003	10/24/2003	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Feeling hot; Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U106AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0358M~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211374	10/31/2003	SC	72.0	72		F	10/27/2003	Left upper arm swelling, red, warm to touch, painful to move arm, nausea, fever 100 degrees after shot.									Y	10/24/2003	10/24/2003	0	NONE	PVT	PVT	NONE	NONE	Arteriosclerotic cardiovascular renal disease; Hypertension, Insullin-dependent Diabetes mellitus;			1						1	Feeling hot; Hypokinesia; Injection site erythema; Injection site oedema; Nausea; Pain; Pyrexia	FLU3~EVANS VACCINES~765851~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0740N~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211375	10/31/2003	MO	28.0	28		F	10/27/2003	Received fluvirin at 09:00 on 10/17/2003.  Developed hives around 16:00 that day.  Hives started at ankles then spread up legs and trunk.  Hives resolved in 36 hours.  Patient took Benadryl for hives.									Y	10/17/2003	10/17/2003	0	NONE	PVT	PVT	Septra DS-took 7th final dose 10/17/2003	UTI (last day of treatment 10/17/2003)	NONE			1						1	Urticaria	FLU3~EVANS VACCINES~765670~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211376	10/31/2003	OH	62.0			F	10/23/2003	4 cm erythema with mild induration at injection site.  Improvement over 24 hours.									Y				NONE	PVT	PVT	Zestril, HCTZ, Maxair, Slow K	NONE	Hypertension, Asthma, Fatigue			1						1	Injection site erythema; Injection site induration	FLU3~EVANS VACCINES~765854~3~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0664N~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211377	10/31/2003	TX	54.0			M	10/16/2003	Received influenza vaccine on 10/10/2003.  States when woke up next day on 10/11/2003, approximately about 7:30 AM, felt shortness of breath, wheezing, headache and rapid heartbeat lasting 2 days.  Resolved on it's own.									Y	10/10/2003	10/11/2003	1	SHORTNESS OF BREATH-NONE	PUB	PUB	Glucophage 5mg/500mg; Monopril 40mg; Toprol; Paxil 20mg	NONE	NONE			1						1	Dyspnoea; Wheezing	FLU3~SANOFI PASTEUR~U1074AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211414	10/31/2003	CA	1.17	1	.2	M	10/30/2003	14 days after vaccination, 2 cm induration/tenderness, diffuse swelling.									Y	10/15/2003	10/16/2003	1		PVT	UNK						1						1	Injection site induration; Injection site oedema; Pain	FLU3~EVANS VACCINES~592B9~4~~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PNC~PFIZER\WYETH~492410~4~~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0211507	10/31/2003	TX	67.0	67		F	10/31/2003	very large swelling and high temperature at site of injection. Difficult Breathing, wheezing, fast heart beat. Blood preasure 130 over 87  Patient refused to seek medical attention. I had a reaction like this seven years ago and should not have gotten the shot. I will live.									Y	10/30/2003	10/30/2003	0		PUB	UNK	Toporol xl 10mg Norvask 10 MG Lipitor 20 mg	None	none	Similar to above~Influenza (Seasonal) (no brand name)~~60.00~In Patient		1						1	Blood pressure increased; Dyspnoea; Heart rate increased; Injection site swelling; Injection site warmth; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0211508	10/31/2003	CO	63.0	63		F	10/31/2003	Very sore arm, lymph node tenderness in armpit area and on rib cage area adjacent to injected arm site.									Y	10/29/2003	10/30/2003	1		PUB	PVT	synthroid estradiol	none	penicillin, ceftin, naprosine, codeine.	same~Influenza (Seasonal) (Fluvirin)~~62.90~In Patient		1						1	Injection site pain; Lymphadenopathy	FLU3~EVANS VACCINES~765959~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211511	10/31/2003	NH	33.0	33		U	10/31/2003	24 hours after the administration of the vaccine 10/14/03 the employee complained of asthma type symptoms including shortness of breath and chest tightness. He was seen in the ER on 10/15/03, oxygen was administered and he was released. Employee reported on 10/28/03 that following the ER visit he developed hives on chest, back, arms and hands. States he has been taking benedryl prn for symptoms. Employee denied egg allergy at the time of vaccination but stated on 10/28/03 that he did have a sensitivity to chicken feathers. Employee states that he is still experiencing mild asthma type symptoms. He was advised to follow up with his MD.				Y					U	10/14/2003	10/15/2003	1		PVT	UNK		No				1						1	Asthma; Chest discomfort; Dyspnoea; Hypersensitivity; Urticaria	FLU3~SANOFI PASTEUR~U1134BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211514	10/31/2003		36.0	36		F	10/31/2003	Flu Vaccine recieved on 28Oct2003-no immediate reaction. 24h later, arm bright read 1 inch around injection site, itching, cutaneous skin pain, minimal muscle pain. Progressed to 2 inch bright red area around injection site. Hot to touch severe itch resolves with Benadryl.				Y					U	10/28/2003	10/29/2003	1	Please note: Influenza was manufacturer was PowerJect Pharmaceuticals	MIL	MIL	ppd skin test	Just over mild GI sx	na			1						1	Injection site erythema; Injection site hypersensitivity; Injection site warmth; Myalgia; Pain; Pruritus	FLUX~UNKNOWN MANUFACTURER~76516~7+~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~SANOFI PASTEUR~U0819AA~7+~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0211515	10/31/2003	MA	67.0	67		F	10/31/2003	DIZZINESS, WEAKNESS ,OUT OF SORTS ,SLEEPY ,  WENT TO HOSPITAL     CHECK ME FOR HEART, ANEMIA AND SUGAR, ALL OK, STILL FEEL SYMPTONS FEEL OUT OF SORTS WEAK VERY TIRED				Y					Y	10/29/2003			BLOOD TESTS  ALL NEGATIVE EKG NEGATIVE	UNK	UNK		NO				1						1	Asthenia; Dizziness; Fatigue; Incoherent; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0211516	10/31/2003	CO	14.0	14		M	10/31/2003	Appx 30 mins after recieving flu shot (Aventis LOT#U1075AA Exp 6/30/04) and Hepatitis A (Merck  LOT# 1411L Exp 3/14/2004) patient had appx 30 second grand mal seizure. This was observed by mother only who wheeled pt back to dept for appx 90 min observation. No further seizure activity was noted by medical personel or mother. Patient has severe CP, non-verbal, seizure disorder. Has been on Lamictal daily for several years. The medical record received on 2/3/04 states postictal. sleepy.				Y					Y	10/27/2003	10/27/2003	0	VSS throughout observation period.	PVT	PVT	Lamictal   Acyclovir	Herpatic lesions of lip that appeared that morning per mother	Severe CP, Seizure disorder, Allergic conjunctivitis, Hip dysplasia, HSV			1						1	Grand mal convulsion; Somnolence	FLU3~SANOFI PASTEUR~U1075AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1411L~1~IM~RA~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0211518	10/31/2003	MN	70.0	70		M	10/31/2003	Approx. 12 hrs after vaccine I suffered chills which lasted several hours but no fever. Following day was weak and stiff and developed fever about 9 PM day after vaccine. After a good night's sleep I returned to normal and remain well.									Y	10/28/2003	10/28/2003	0		UNK	UNK	Lipitor Claretin Atenonol	None	penicillin			1						1	Asthenia; Chills; Musculoskeletal stiffness; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211520	11/01/2003	FL	50.0	50		F	11/01/2003	When I recieved the injection there was a slight sting. My arm swelled at the injection site. I had a whelp 1.5 by 2.5 with burning,itching at sight for 5 days now. It is starting to clear. I had recieved a flu vacination last December for the first time, this is my second flu shot. I did have some tightness in my chest for 1-2 days. Since I have asthma, I just used my inhaler and was not overly concerned, I did call the wellness center and also my allergy specialist just to have it documented.									Y	10/27/2003				PVT	PVT		None	Allergies,Asthma			1						1	Chest discomfort; Injection site hypersensitivity; Injection site swelling; Pruritus; Thermal burn	FLU3~EVANS VACCINES~765137~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211521	11/01/2003	TX	50.0	50		M	11/01/2003	Immediate left arm soreness, traveling into left arm and into neck.  Now, after over 9 hrs. pain exists;  General tiredness occured about 2 hrs. later;  Approx. 4 hrs. after injection, severe nausea, dizziness, headache, paleness and clamminess, profuse sweating, extreme muscle weakness.  Patient sat on edge of bed for about 5 minutes with fan directly on.  Then laid down in bed and slept for 3 hrs.  After awakering, nausea, tiredness and weakness still present.  Next morning, nausea (though not severe), muscle tiredness, and fatigue continues.  Soreness in arm, shoulder and neck continues.									U	10/31/2003				UNK	UNK		None	Pennicillin.  Patien bipolar. Diabetic type 2 non-insulin.			1						1	Cold sweat; Dizziness; Fatigue; Headache; Hyperhidrosis; Muscular weakness; Nausea; Neck pain; Pain; Pallor	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0211526	11/02/2003	ND	52.0	52		F	11/02/2003	Muscle aches around the neck area dizziness starting the next morning after shot administered. Muscle aches gone 4 days later but dizziness persists. I have not goe in for any treatment.									Y	10/29/2003	10/30/2003	1		PVT	PVT	none	none	none			1						1	Dizziness; Myalgia; Neck pain	FLU3~SANOFI PASTEUR~U1103AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211528	11/02/2003	CA	0.9	60		F	11/02/2003	My right arm became very swollen, red and painful from the injection site down to below the elbow. Clinic does mention whether or not vaccine contains thimersol when they ask about allergic reactios.				Y					N	10/30/2003	10/31/2003	1		UNK	UNK		none				1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211529	11/02/2003	WA	43.0	43		M	11/02/2003	Patient felt dizzy, eyes were burning, and he had mild respiratory distress.  Patient was seen 2 hours later, and was feeling much better.  His blood pressure was normal.									Y	11/01/2003	11/01/2003	0	No treatment necessary.	MIL	MIL		None	None			1						1	Dizziness; Eye irritation; Respiratory distress	ANTH~EMERGENT BIOSOLUTIONS~FAV076~2~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1098AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211530	11/02/2003	OH	24.0	24		F	11/02/2003	10 hours after vaccination at place of employment, patient experienced rigors, fever of 101 degrees, dizziness, fatigue, myalgias, and shortness of breath. Patient's symptoms resolved two days after vaccination, self-administration of acetaminophen, and plenty of sleep.									Y	10/31/2003	10/31/2003	0	None	PUB	UNK	Kariva (oral contraceptive)	No	Allergy to sulfonamides (rash)			1						1	Chills; Dizziness; Dyspnoea; Fatigue; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~Unknown~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211462	11/03/2003	SC	40.0	40		F	10/28/2003	Within 15 minutes of injection, rash, tingling of tongue/ lips and wheezing developed. Pt has asthma and was on a medrol dose pak. Given po Benadryl total of 50mg with improvement within 30 minutes got worse take to ER intubated and on ventilator x 2 da. Now home and OK. Throat remains sore due to respirator. Discharge summary states vomiting, sweat, apnea, facial edema. msv				Y	Y	3			Y	10/16/2003	10/16/2003	0	NONE Discharge summary states abnormal lab tests. msv	OTH	PVT	Medrol dosepak		Asthma Discharge summary states headache, depression, allergy, hypertension, paralysis of face, GI disorder, Kidney stone. msv			1						1	Apnoea; Face oedema; Hyperhidrosis; Laboratory test abnormal; Paraesthesia; Rash; Vomiting; Wheezing	FLU3~SANOFI PASTEUR~U1076AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0211463	11/03/2003	LA	40.0	40		F	10/30/2003	L arm-sore next morning. Induration 15mm x 20mm, erythema 25-30mm									Y	10/28/2003	10/29/2003	1		PUB	PUB	Panmist LA	NONE	NONE			1						1	Erythema; Pain	FLU3~SANOFI PASTEUR~U1271AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211464	11/03/2003	LA	55.0	55		F	10/30/2003	Onset red mark on arm (noted by husband). Induration 36x38mm, erythema 50x50mm L arm.									Y	10/28/2003	10/29/2003	1		PUB	PUB	Premarin	NONE	Allergic-Clarulagic; knee ?			1						1	Erythema	FLU3~SANOFI PASTEUR~U1271AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211465	11/03/2003	LA	55.0	55		F	10/30/2003	L arm induration 15x18mm, erythema 30x40mm.									Y	10/28/2003	10/30/2003	2		PUB	PUB	Allegra, Phosomax	NONE	Diarrhea (resolved)-3 weeks before			1						1	Erythema	FLU3~SANOFI PASTEUR~U1271AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211466	11/03/2003	LA	51.0	51		F	10/30/2003	Itching and pain on evening of shot L arm. Induration 20x25mm, erythema 40x40mm.									Y	10/28/2003	10/28/2003	0		PUB	PUB	Premarin	NONE	NONE			1						1	Erythema; Pain; Pruritus	FLU3~SANOFI PASTEUR~U1271AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211467	11/03/2003	LA	47.0	47		F	10/30/2003	Soreness of muscle noted same evening. Warm and tenderness in L biceps 70x70mm (skin above not red or erythematous).									U	10/28/2003	10/28/2003	0		PUB	PUB	NONE	NONE	NONE			1						1	Feeling hot; Myalgia; Tenderness	FLU3~SANOFI PASTEUR~U1271AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211468	11/03/2003	LA	39.0	39		F	10/30/2003	Onset pain approximately 39 hours after shot R arm induration 16x18mm, erythema 25x45mm.									Y	10/28/2003	10/30/2003	2		PUB	PUB	Premarin, Lodine, Arava, Atapro, lasix, bactrium, ?	NONE	Tetanus vaccines, Sjogren's syndrome, HTN, aveitis, rheuamtoid arthritis, ambylosing spondylitis	Red swell x 6 weeks~Tetanus Toxoid (no brand name)~3~28.00~In Patient		1						1	Erythema; Pain	FLU3~SANOFI PASTEUR~U1271AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211469	11/03/2003	LA	38.0	38		M	10/30/2003	Began as sore arm L arm induration 20x25mm, erythema 30x50mm.									Y	10/28/2003	10/29/2003	1		PUB	PUB	NONE	NONE	NONE			1						1	Erythema; Pain	FLU3~SANOFI PASTEUR~U1271AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211470	11/03/2003	LA	47.0	47		F	10/30/2003	Noticed severe itching an dpain. Hot feeling L arm indurated 30x34mm, erythema 50x55mm.									Y	10/28/2003	10/28/2003	0		PUB	PUB	Maaich, Trigac	NONE	Allergic pecoplan, LB pain, HTN, had IM shot for back pain one month ago.			1						1	Erythema; Pain; Pruritus	FLU3~SANOFI PASTEUR~U1271AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211471	11/03/2003	LA	54.0	54		U	10/30/2003	Severe skin rash L arm induration 53x65mm, erythema 90x110mm.									Y	10/28/2003	10/29/2003	1		PUB	PUB	Tagamet	NONE	NONE			1						1	Erythema; Rash	FLU3~SANOFI PASTEUR~U1271AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211472	11/03/2003	LA	60.0	60		F	10/30/2003	L arm induration 34x36, erythema 60x70mm.									Y	10/28/2003	10/30/2003	2		PUB	PUB	NONE	NONE	Allergic rhinitis, breast cancer 2 years ago (XRT)			1						1	Erythema	FLU3~SANOFI PASTEUR~U1271AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211473	11/03/2003	LA	53.0	53		F	10/31/2003	Itching began same evening. Red and swollen 24 hrs L arm induration 10x12mm, erythema 25x30mm not measured until 96 hrs after (10/31/03).									Y	10/27/2003	10/27/2003	0		PUB	PUB	Atarax, HCTZ, Advair, Albuterol	NONE	Allergic inhalents, allergic rhinitis, asthma, HTN	Rendess~Influenza (Seasonal) (no brand name)~~48.00~In Patient		1						1	Erythema; Oedema peripheral; Pruritus	FLU3~SANOFI PASTEUR~U12711AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211474	11/03/2003	LA	56.0	56		F	10/30/2003	Onset itching approximately 24 hrs. Then developed swelling and redness L arm induration 20x22mm, erythema 30x36mm.									Y	10/28/2003	10/29/2003	1		PUB	PUB	Deaven, Glinase, Glucophage, Celexa, Wellbutrin, Atendol, insulin	NONE	AODM, HTN, depression			1						1	Erythema; Oedema peripheral; Pruritus	FLU3~SANOFI PASTEUR~U1271AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211475	11/03/2003	LA	46.0	46		F	10/30/2003	Noted pain and swelling in arm next morning L arm 60x65mm swelling in muscle (skin above minor erythema only).									Y	10/28/2003	10/29/2003	1		PUB	PUB	Toprol, Norvasc, Tenex, Avapro, Suonolacton					1						1	Erythema; Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~U12711AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211476	11/03/2003	LA	53.0	53		M	10/30/2003	Noted arm lesion only after asked ? L arm induration 18x18mm, erythema 25x25mm.									Y	10/28/2003	10/30/2003	2		PUB	PUB	Amprol, Glucophage, babyaspirin, Lesinopril, Norvasc	NONE	HTN, AODM			1						1	Erythema; Skin ulcer	FLU3~SANOFI PASTEUR~U12711AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211477	11/03/2003	LA	36.0	36		F	10/30/2003	Onset soreness at 18 hrs l arm induration 27x29mm, erythema 40x55mm.									Y	10/28/2003	10/30/2003	2		PUB	UNK	NONE	NONE	NONE			1						1	Erythema; Pain	FLU3~SANOFI PASTEUR~U1271AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211478	11/03/2003	CA	2.08	2	.1	M	10/31/2003	Pt had swelling of the L thigh which has increased over 24 hrs.									Y	10/29/2003	10/30/2003	1		PVT	UNK						1						1	Oedema peripheral	FLU3~SANOFI PASTEUR~U1122AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~494314~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0211479	11/03/2003	NY	53.0	53		M	10/31/2003	Macular papular erhthemic rash over creases in skin, started evening after pt got the flu shot. Pt given medrol dose pack.									U	10/27/2003	10/27/2003	0	NONE	PVT	UNK	Monopril, Ecolhn, ?	NONE	PCN, Ceclor, Tetracycline			1						1	Rash erythematous; Rash maculo-papular	FLU3~EVANS VACCINES~765670~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211480	11/03/2003	NY	40.0	40		F	10/31/2003	Sweats, fever, emesis treated by personal physician with Benadryl and Cipro x 3 days.				Y					Y	10/27/2003	10/29/2003	2	UNK	OTH	OTH		NONE	NONE			1						1	Hyperhidrosis; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1127AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0863N~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211481	11/03/2003	TX	62.0	62		M	10/31/2003	Pt c/o Rt arm started hurting later that evening. The pain radiates from Rt shoulder down to hand. Pain is intermittent. No redness or swelling at site or arm was noted by pt and family members. Pain intermittent x 1 week. Spoke to pt several times during week but did not mention during those times.				Y					U	10/23/2003	10/23/2003	0	RUE pain-likely secondary flu shot.	PVT	PVT	Predrotle, Xalaton, Truspot, metformin, Neurontin, Zoloft, Diovan, Soma, Ronitrl, Nortriptyline		Propanotol, DM, abd hernia, glaucoma, cataract, insomnia, HTN, OA, depression			1						1	Pain	FLU3~EVANS VACCINES~765484~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0211482	11/03/2003	MI	7.0	7		M	10/31/2003	Hives occurred about one hour after flu vaccine administered. No shortness of breath. Treated with Benadryl.				Y					Y	10/29/2003	10/29/2003	0	NONE	PVT	PUB	Singulair		Asthma			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1088AA~5~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211483	11/03/2003	DC	26.0	26		F	10/30/2003	Reports ? swelling, hives palms, legs evening of 10/29.  Resolving when seen 10/30 by provider.									Y	10/29/2003	10/29/2003	0	NONE	PVT	PVT	NONE	NONE	PCN			1						1	Oedema; Urticaria	FLU3~SANOFI PASTEUR~u1089aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~u1001aa~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0211484	11/03/2003	WA	53.0	53		F	10/30/2003	Nausea, metallic taste in throat, lasted 5 minutes.									Y	10/03/2003	10/30/2003	27	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Dysgeusia; Nausea	FLU3~SANOFI PASTEUR~U1277AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211485	11/03/2003	CA	49.0			M	10/22/2003	Patient complained of severe achy arm left and left shoulder for 5 days. Concerned regarding 3mm pink area with clear dried serous droplet at puncture site.  No signs of swelling, nodular area, redness.  Denies any pain today denies fever at any time.									Y	10/13/2003	10/14/2003	1	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Injection site erythema; Pain	FLU3~EVANS VACCINES~765497~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211486	11/03/2003	MO	5.0	5		F	11/01/2003	Right thigh 6-7 inch area with irregular edges sup erythema.									Y	10/16/2003	10/17/2003	1	NONE	PVT	OTH	NONE	Abdomen pain?; Lactose intolerance?	NONE			1						1	Erythema	DTAP~GLAXOSMITHKLINE BIOLOGICALS~610A2~5~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1266AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~U1619~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0359N~2~SC~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA		Influenza
0211489	11/03/2003	GA	34.0	34		F	10/08/2003	Complained of pain, redness and swelling at injection site; some itching at site also.  Redness and swelling size of silver dollar.  Is taking Tylenol and Benadryl.  To put ice on site also.									Y	10/06/2003	10/07/2003	1	NONE	PUB	PUB	NONE	NONE	NONE		GA03106	1						1	Injection site erythema; Injection site oedema; Injection site pain; Pruritus	FLU3~EVANS VACCINES~765664~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211491	11/03/2003	GA	53.0	53		F	10/08/2003	10/07/2003: Client reported severe headache during the night.  Did not take any medication.  Headache this AM is moderate.  Injection site swollen with bruising noted at site.  Swelling approximately 3 inches in diameter.  Instructed to take Tylenol and use ice packs on area.  To consult with MD about Benadryl since has glaucoma.				Y					Y	10/06/2003	10/07/2003	1	Reaction to swine flu vaccine 25 years ago or so.  No problem with last flu shot.	PUB	PUB	ASA 81mg; Glaucoma medications; High blood pressure meds	NONE	Hypertension, Glaucoma	numbness in legs~Influenza (Seasonal) (no brand name)~~0.00~In Patient	GA03108	1						1	Contusion; Headache; Injection site oedema	FLU3~EVANS VACCINES~765664~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0211492	11/03/2003	GA	47.0	47		F	10/08/2003	2.5 to 2 3/4 inch area of redness and swelling at injection site.  To take Tylenol, Benadryl and apply ice to site.									Y	10/06/2003	10/07/2003	1	NONE	PVT	PVT	NONE	NONE	NONE		GA03109	1						1	Injection site erythema; Injection site oedema	FLU3~EVANS VACCINES~765664~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211495	11/03/2003	AK	38.0	38		F	10/24/2003	Shot given on Friday 10/17/2003.  Immediately following shot had metallic taste in mouth that lasted all day, dizziness on and off and shortness of breath on and off all day.  By evening had back ache, on saturday, back, legs and hips; sunday whole body ache that continued until wednesday.									Y	10/17/2003	10/17/2003	0	NONE	OTH	OTH	PPD (AP) (Lot # C1615AA) (IM/LFA) (5 previous doses)	NONE	NONE			1						1	Dizziness; Dysgeusia; Dyspnoea; Pain	FLU3~SANOFI PASTEUR~U1141AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211506	11/03/2003	WA	75.0	75		M		This subject is a 76 year old male who died while enrolled in the RSV11 study. The subject received RSV vaccine or Placebo and influenza vaccine on 11/13/02. The investigator was informed by one of the family members that the subject had died in July, 2003. Specific dates not reported. Causality was not reported. Further info from the investigator has been requested. The death certificate received on 11/20/03 states myocardial infarction and CAD. Follow up on 11/26/03: Efforts are being made to contact next of kin and to obtain a death certificate through the State.  No details are known at this time. Additional info received 11/18/03.  The subject died on 07/08/03, 237 days post immunization.  Death Cert: Cause of Death: Acute MI due to CAD.  The acute MI was reported by the investigator as not related to the study vaccine. Follow up on 12/16/2003: Additional information received 12/01/2003: Complementary Information Form: Diagnoses at Enrollment: COPD, Bronchiectasis, Ischemic heart disease.  Medication: Psyllium oral power, Ranitidine, Furosemide, Nitroglycerin, Albuterol, Beclomethasone NS, Hydrocodone/Acetaminophen, Tamazepam, Ipratropium bromide inhaler, Lisinopril, Salmeterol inhaler, Prednisone, Theophyline.	Y								N	11/13/2002	07/01/2003	230		UNK	UNK	RSV/Placebo; Psyllium oral power, Ranitidine, Furosemide, Nitroglycerin, Albuterol, Beclomethasone NS, Hydrocodone/Acetaminophen, Tamazepam, Ipratropium bromide inhaler, Lisinopril, Salmeterol inhaler, Prednisone, Theophyline				200302689	1						1	Coronary artery disease; Myocardial infarction	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0211589	11/03/2003		33.0			M	11/03/2003	Within 1 hour of vaccination with both smallpox and flu vaccine, he began to feel shortness of breath and then progressed to throat and chest tightness.  Mild dizziness and weakness.  No syncope or hives noted.  some pruritus				Y					Y	10/24/2003	10/24/2003	0	Flu vaccine was by powerject Pharm	MIL	MIL		None	No significant illnesses			1						1	Asthenia; Chest discomfort; Dizziness; Dyspnoea; Pruritus; Throat tightness	FLUX~UNKNOWN MANUFACTURER~765141~7+~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4020071~1~SC~LA~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0211590	11/03/2003	OH	43.0	43		F	11/03/2003	Within a period of an hour or so after receiving the immunization, the vaccinee developed itching, flushing, chest discomfort, and breathing difficulty.  She was at work as an RN in a hospital so, as she collapsed and began to seize, a code was called.  She was intubated and taken to the ICU where she remains at this time.  She has been extubated. Nurse follow up on 06/28/04 states: ADD: Anaphylactic reaction, respiratory failure, pseudo seizure, gastritis, left sided weakness.			Y	Y	Y				Y	10/31/2003	10/31/2003	0	normal head CT X 2 normal EEG Serum electrolytes (wnl)	PVT	PVT	None	None	Allergies to grass, molds, ragweed, dogs and cats; all causing eye, nose and throat irritation; post traumatic stress syndrome; Endometriosis;			1						1	Anaphylactic reaction; Apnoea; Chest discomfort; Convulsion; Dyspnoea; Flushing; Gastritis; Loss of consciousness; Pruritus; Anaphylactic reaction; Convulsion; Gastritis; Hemiparesis; Rash; Respiratory arrest	FLU3~EVANS VACCINES~765877~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation	Influenza
0211591	11/03/2003	IA	5.0	71		M	11/03/2003	Pain in right deltoid, decreased mobility of right shoulder, nausea, chills and fatigue all on 10/31/03 Above symptoms continued and redness approx 8 inches surrounding injection site noted on 11/01/03 Treatment: Ice to injection site and tylenol for the pain									Y	10/31/2003	10/31/2003	0	None	PUB	PUB	Adalat 30 mg HS Asa 81 mg QD	NONE	NKA, MI in 1984, Raynaud phenomenon in 1995			1						1	Chills; Fatigue; Injection site erythema; Joint range of motion decreased; Nausea	FLU3~EVANS VACCINES~766050~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0256N~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211592	11/03/2003	OH	68.0	68		F	11/03/2003	Became nauseated, dizzy and had muscle weakness.  Next morning 10/30 continued to have severe muscle weakness, greater on L side of body.  Went to ER.  All tests WNL.  Went home prior to recommended overnight stay for stress test.  No diagnosis made at ER.  Muscle weakness continues to date.  Personal physician retired and has appt. with new doctor on 11/17.				Y					N	10/29/2003	10/29/2003	0	10/30 blood work and CXR at ER. All WNL.	PUB	PUB	None reported	None reported	None reported other than hx of muscle aches in legs.			1						1	Dizziness; Muscular weakness; Nausea	FLU3~SANOFI PASTEUR~U1098AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211593	11/03/2003	NC	31.0	31		M	11/03/2003	23 Oct 2003 Received vaccinations on this date.  Reports he attended the briefings on smallpox and anthrax vaccinations and received the brochures.No complaints on this date except he had cold symptoms-runny nose, stuffy head. 28 Oct 2003 Noticed approximately 4 bumps like zits on his right thigh.  No itching, no pain.  Went away on their own after a couple of days. 01 Nov 2003 Noticed red streaking from smallpox vaccination site to approximately 2 inches medial to left axillary area.  Also noted tender knot on neck.  No headache, no dizziness.  Neck pain only localized to swollen lymph node.  Had a fever of 102 that normalized after Motrin.  Feels a little more tired than usual.Also noted a canker sore on tip of tongue.Denies any chest pain or palpitations.  Shortness of breath noted only after a long run but not with normal activities or at rest.  No cough. 02 Nov 2003 Continued symptoms as above.  Fever of 99.7 that normalized after Motrin. 03 Nov 2003 Referred to the VHC.  No fever today.  Continued erythematous streaking from SPV to approximately 2 inches medial to left axillary area.  Continued tender, swollen lymph node in posterior cervical neck area and axillary area.  Continued oral canker sore.  No other oral lesions.  No lesions on palms or soles.  Few discrete bumps noted on left upper arm and one on chest.  Lesions non-pruritic.  However, patient does complain of itching at SPV site.No complaints of pain, numbness, tingling, or edema at location of anthrax or other vaccinations.  ASSESSMENT:  1. Lymphadenopathy-Left posterior cervical and axillary- Normal side effect associated with smallpox vaccination 2. Lymphangitis-Normal variant associated with smallpox vaccination 3. Robust smallpox vaccination with erythema and edema surrounding vaccination site. 4. Non-viral pustulosis  5. Aphthous ulcer  Treatment Plan: 1. Motrin 800 mg po tid #30 with no refills for comfort. 2. Allegra 180 mg po qd #30 with no refills to relieve itching. 3. Provided patient education and reassurance regarding expected side effects and normal variants of the smallpox vaccination.  Reinforced education on care of the SPV vaccination to prevent transfer of the Vaccinia virus. 4. In a pre-event setting, he should be exempt from all future smallpox vaccinations unless direct exposure occurs. 5. Return visit x 2 days to reassess lymphangitis and lesions. 6. Discussed other symptoms to watch for: instructed patient if he has any chest pain, palpitations, increased shortness of breath, he should go to the emergency room immediately.				Y					U	10/23/2003	10/28/2003	5	None	MIL	MIL	None	Upper Respiratory Infection	No known food or drug allergies. PMH:  o Knee injury o Otherwise good health.  Specifically denies any history of asthma, allergic rhinitis, hypertension, heart murmur, heart disease, or any past skin diseases.  Surgical History: o  Vasectomy o Tooth extraction			1						1	Aphthous stomatitis; Injection site erythema; Injection site swelling; Lymphadenopathy; Lymphangitis; Neck pain; Pharyngitis; Pyrexia; Rhinitis; Rhinorrhoea; Skin ulcer	ANTH~EMERGENT BIOSOLUTIONS~FAV077~1~SC~RA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~unknown~7+~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~unknown~2~IM~RA~HEP B (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4020074~1~ID~LA~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~unknown~3~IM~RA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0211595	11/03/2003	VA	44.0	43		F	11/03/2003	ABOUT 10 MIN POST INJECTION A HALF DOLLAR SIZE RASH APPEARED OVER INJECTION SITE. WAS ITCHY SO EMPLOYEE APPLIED BENADRYL CREAM AND RETURNED TO EMPLOYEE HEALTH OFFICE. I HAD HER SIT FOR ANOTHER 10 MIN. NO FURTHER ENLARGING OF RASH OR COMPLAINTS OF OTHER SYMPTOMS. EMPLOYEE RETURNED TO HER JOB. SUDDENLY FELT VERY ODD AND BEGAN HAVING SOME BREATHING DIFFICULTY. COWORKER TOOK HER TO EMERGENCY ROOM WHERE EMPLOYEE RECEIVED A BREATHING TREATMENT AND STEROID MEDICATIONS AND A NEBULIZER. EMPLOYE RETURNED TO WORK.				Y					Y	10/31/2003	10/31/2003	0	NONE	PUB	PVT						1						1	Dyspnoea; Injection site hypersensitivity; Malaise; Pruritus; Rash	FLU3~EVANS VACCINES~765795~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0211596	11/03/2003	NY	33.0	33		F	11/03/2003	Shortness of breath				Y					Y	11/03/2003	11/03/2003	0		PUB	UNK			Asthma			1						1	Dyspnoea	FLU3~SANOFI PASTEUR~41076AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211597	11/03/2003	MN	71.0	71		M	11/03/2003	Patient developed lower extremity rash 4 days 10/26 after vaccine administered on 10/22.  Presents to clinic now on 11/03 with confluent lower extremity rash and mac/papular on trunk and upper extremities. Lower extremities with non-pitting edema and bullae forming and pt c/o lower ext. joint pain.				Y					Y	10/22/2003	10/26/2003	4		UNK	UNK		None	None			1						1	Arthralgia; Oedema; Rash; Rash maculo-papular	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0211599	11/03/2003	NE	24.0	24		M	11/03/2003	Lump developed under axilla of left arm where vaccination was given.  Seen by physician.				Y					Y	10/24/2003	10/25/2003	1		PUB	UNK				Lump developed under axilla of arm~Influenza (Seasonal) (Fluzone)~~0.00~In Patient		1						1	Injection site mass	FLU3~SANOFI PASTEUR~U1094AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211600	11/03/2003	GA	44.0	44		M	11/03/2003	102.7 fever, severe body aches, nausea, began 24 hours after shot.  Saw Doctor, was told I had flu like sickness but had not gotten it from the shot.  Treated with pain medication and nausea medication.  Symptoms subsided at approx 84 hours later.  Shot Thurs afternoon, sick friday afternoon, sick saturday and Sunday, began recovery Monday morning.				Y					Y	10/30/2003	10/31/2003	1	Dr's visit on Nov 1.  Discussed symptoms, temp, blood presure, general exam.	PUB	PVT	None	None	None			1						1	Influenza like illness; Nausea; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0211601	11/03/2003	CA	32.0	32		F	11/03/2003	Patient complained of itching @ injection site(Right Deltoid), approximately 15 minutes after administration of Fluvirin Vaccine.  Noted mild redness & rash at injection site.  Patient denied shortness of breath. Diphenhydramine 25mg(2 tabs) given P.O. with good results. Rash and redness resolving in 15 minutes. Patient dismissed to home at 9:35am									Y	10/29/2003	10/29/2003	0	None	PUB	PUB	Albuterol Inhaler - 2 puffs	None	History of Asthma			1						1	Injection site erythema; Injection site hypersensitivity; Injection site rash; Pruritus	FLU3~EVANS VACCINES~765851~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211602	11/03/2003	AZ	47.0	47		F	11/03/2003	Injection rec'd 10/26/2003 administered by nurse as part of group immunization. After one week, the skin on the palms of my hands and the soles of my feet is extremely sensitive and red.  I rec'd the Swine flu vaccine 10/1976 and three wks later all the skin on my palms and soles peeled off in sheets, making these areas very sensitive--like a burning sensation.  Now this is happening again!  I have not rec'd a flu shot since 1976 because of what happened.  This year I tried again because I thought maybe things have changed.									U	10/26/2003	11/02/2003	7		UNK	PVT	Lisinopril	none		burning/peeling skin palms and soles~Influenza (Seasonal) (no brand name)~~20.80~In Patient		1						1	Erythema; Hyperaesthesia; Skin burning sensation; Skin exfoliation	FLUX~UNKNOWN MANUFACTURER~unknown by me~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211604	11/03/2003	FL	15.0	15		F	11/03/2003	Loss of consciousness, convulsive syncope or seizure (2 episodes) immediately following the administration of the flu and diptheria-tetanus booster vaccinations.  The patient was transported by ambulance to the hospital.  She is seeing a neurologist for further tests.				Y					Y	10/19/2003	10/19/2003	0	MRI, CAT scan, EEG	UNK	UNK	Accutane	None	Birth defects-Tracheo-esophageal fistula and Esophageal atresia (surgically corrected after birth) Atypical asthma			1						1	Convulsion; Loss of consciousness; Syncope	DT~SANOFI PASTEUR~61000A~4~IM~LA~DT ADSORBED (NO BRAND NAME)~1|FLU3~EVANS VACCINES~765710~1~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0211605	11/03/2003	CO	79.0	79		F	11/03/2003	immediately following administration of Pneumovax, patient became flushed and reported a racing heart and chest tightness.  She described it as like receiving an aminophylline shot.  The patient was given 25mg of liquid Benadryl.  She was observed for 30 minutes until her symptoms resolved completely.  The patient was told to follow up with her physician and to report to the ER if symptoms recur.									Y	10/02/2003	10/02/2003	0		PUB	PVT	Lisinopril, Albuterol, Pulmicort, Synthroid	None known	High blood pressure, asthma			1						1	Chest discomfort; Flushing; Heart rate increased	FLU3~SANOFI PASTEUR~U1069AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0256N~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211534	11/04/2003	CA	67.0	67		M	10/29/2003	(10/29) S: received yellow fever L post. tricep on 10/21. Next day noticed more redness 6 in from inj site. site warm. On 10/22 area increased in size and began to feel painful. No N/V, slight itchiness, no rash. (10/24) - present to clinic with of pain (3-4/10), red, warm area. O: 4x8cm erythmic, high temp plague (L) bicep ending 2-3 on above antecubital. No tx wanted to phone call to client. Arm all clear be seen by PCP.									Y	10/21/2003	10/22/2003	1		PUB	PVT						1						1	Erythema; Injection site erythema; Injection site pain; Injection site warmth; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~U1092AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~SMITHKLINE BEECHAM~745A6~UNK~IM~RA~HEP A (HAVRIX)~1|PPV~MERCK & CO. INC.~0256N~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|YF~SANOFI PASTEUR~UB422AA~UNK~SC~LA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0211535	11/04/2003	NY	59.0	59		M	10/29/2003	Death approx 6 to 7 hrs after vaccine administration. The death certificate state cardiopulmonary arrest and CAD.	Y	10/15/2003							N	10/15/2003	10/15/2003	0	NONE	PVT	PVT	Hyzaar, Advair	NONE	HTN, probable emphysema			1						1	Cardio-respiratory arrest; Coronary artery disease	FLU3~EVANS VACCINES~765874~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1212M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U1001AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Results in Death	Influenza
0211541	11/04/2003	MI	85.0	84		M	10/29/2003	From initial information received on 10/27/03 from a hospital clinic regarding an adverse event occurring in the USA, it was reported that a female patient received FLUZONE, lot number U1081AA, administered IM in the left arm on 10/10/03. The patient also received an unspecified allergy injection that same day. The next day, the patient experienced general malaise, fatigue, nausea, and vomiting and weakness. She also experienced fever, but the reporter was unsure of the exact reading. The patient was hospitalized on an unspecified date. The recovery status was reported as unknown and it was noted that the patient was still in the hospital at the time of this report. Follow up on 11/13/2003: From additional information received through a telephone call on 11/06/2003 from a health care professional, the patient's date of birth was provided.  The patient was an 84 year old female, who received the influenza vaccine on 10/10/2003.  On 10/13/2003, the patient was seen in the ER, released, and saw her primary physician.  She was hospitalized from 10/20/2003 to 10/23/2003 for a diagnosis of pneumonia.  The primary physician's information was provided.  Reportedly, the patient recovered from this event.  A phone call was made to the patient's primary physician requesting a discharge summary, which was to be faxed if available.  No further information was provided.  From additional information received through a telephone call on 11/07/2003 from a health care professional, the patient's gender was clarified.  The patient is a male.  No further information was provided. Follow up on 05/17/04 states: No additional information was obtained. No further information is anticipated, this case is considered closed. Follow up 01/06/05: Medical Assessment: The amount of availabe data is not sufficient to assess this case.				Y	Y				U	10/10/2003	10/11/2003	1		PVT	PVT		NONE	NONE		200302790	1						1	Asthenia; Fatigue; Malaise; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1081AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0211549	11/04/2003	PA	74.0	73		F		This subject is a 74 year old female who was diagnosed with right lung carcinoma while enrolled in RSV11 study. The subject received RSV vaccine or Placebo and influenza vaccine on 10/15/02. The subject's start date for the lung cancer was 4/18/03, 185 days post immunization. He was diagnosed 4/03 (specific date not reported). Treatment included chemotherapy and radiation. The subject is not recovered and will not continue in the study as of 10/28/03. The event was reported by the investigator as not related to the study vaccine.			Y						N	10/15/2002	04/18/2003	185		UNK	UNK	RSV/Placebo		COPD		200302802	1						1	Lung neoplasm malignant	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0211550	11/04/2003	NY	72.0	72		M		This subject is a 72 year old male who died while enrolled in the RSV11 study. Subject received RSV vaccine or Placebo and influenza vaccine on 10/15/2003. The subject developed shingles 10/19/03, 4 days post immunization and 7 days later, on 10/26/03 he had increasing shortness of breath and died while on the way to the hospital. The death was reported by the investigator as possibly related to the study vaccine.  Follow up on 12/10/03: Additional info received 12/01/03.  Death cert received with the date of death being 10/28/03 not 10/26/03 as stated in the initial report . Cause of death was CHF w/approximate interval of 2 weeks between onset and death.  Due to or as a consequence of CAD w/appropriate interval of years between onset and death.  Due to or as a consequence of Idiopathic Pulmonary Fibrosis w/approximate interval of months between onset and death. Follow up on 02/09/04: The causality has been changed by the investigator from possible relationship to unrelated.	Y	10/28/2003							N	10/15/2003	10/26/2003	11		UNK	UNK	Norflex, Aspirin, Diltiazem, Zocor, Vioxx, folic acid, Actonel, Prednisone, Nystatin		COPD, pulmonary fibrosis-end stage-diagnosed 6/2003. Angioplasty and stent 2001.		200302804	1						1	Dyspnoea; Herpes zoster	FLU3~SANOFI PASTEUR~U1137HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0211554	11/04/2003	UT	55.0	55		F	11/03/2003	CP received with sl NTG. Required admit r/o MI. NI cardiolyte study. All one hr post vaccine. Back to nl by next am. Discharge summary states chest pain. msv			Y	Y	Y	3			Y	10/16/2003	10/16/2003	0		PVT	PVT	Vioxx	Muscle spasms R calf Discharge summary states hypertonia. msv	Osteoarthritis, high cholesterol Discharge summary states hypercholestoremia. msv			1						1	Chest pain	FLU3~SANOFI PASTEUR~U1256AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0211557	11/04/2003	WA	85.0	85		F	10/24/2003	Developed swollen left arm, fever 12 hrs post vaccination. Hospitalized, on high doses antibiotics recovered in 2 days.					Y	3			Y	10/06/2003	10/06/2003	0		PVT	PVT						1						1	Oedema peripheral; Pyrexia	FLU3~SANOFI PASTEUR~U1091AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0554M~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0211562	11/04/2003	NY	28.0	28		F	10/30/2003	At 13:45, 15 minutes after vaccination developed tingling and numbness of sore with itching at ear itching.  No shortness of breath or wheeze.  Benadryl, Prednisone.  At 15:15, developed several papules of arms, otherwise no new symptoms.									Y	10/30/2003	10/30/2003	0	BP: 149/76; Pulse: 96; Temperature: 97.1	OTH	OTH	NONE	NONE	Idiopathic thrombocytopenic purpura; Status post cholecystectomy-2003			1						1	Hypoaesthesia; Pain; Paraesthesia; Pruritus; Rash papular	FLU3~EVANS VACCINES~765795~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211563	11/04/2003	NY	31.0	31		F	10/28/2003	On 10/25/2003 became ill.  Body aches, severe pain of right arm where fluvirin was given down the arm.  Fever of 101.  10/28/2003: Still feels ill and have sore throat.  Referred to MD.									Y	10/23/2003	10/25/2003	2	NONE	PVT	OTH	NONE	Subclinical hyperthyroidism	Allergy to reglan, seasonal			1						1	Injection site pain; Malaise; Pain; Pharyngolaryngeal pain; Pyrexia	FLU3~EVANS VACCINES~765795~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211564	11/04/2003	OR	26.0	26		F	11/03/2003	Woke up next morning: pain and swelling where injection was given.  Numbness in arm.  Mild to moderate swelling in under arm. Lymph nodes in axillary area very swollen and painful  Fevers 99-100.7 degrees.  Pain, numbness and swelling in left axilla radiates to hand and into left breast.  Advil 800mg every 6-8 hours.  Trying Z-pack 2 per mouth for 5 days.									N	10/31/2003	11/01/2003	1	NONE	OTH	OTH	NONE	NONE	Mitral valve prolapse, migraine headaches			1						1	Hypoaesthesia; Injection site oedema; Injection site pain; Lymphadenopathy; Pyrexia	FLU3~SANOFI PASTEUR~U1080AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211565	11/04/2003	CA	46.0	46		F	10/31/2003	Local swelling at injection site about 50 cent piece size 10/06/2003.  Next day 10/07/2003, about 13:00 complained of shortness of breath, generalized itching and rash bilateral arm, chest, neck.  Prescribed: Benadryl at employee health.  Complained of 2nd shortness of breath.  Required albuterol rehab, 5 day prednisone 40mg.				Y					Y	10/06/2003	10/06/2003	0	Latex RAST (-) 10/31/2003: Spirometry normal without reversibility with broncholation.	PVT	OTH	Keflex, Zoloft, Zocor, ASA 81mg; Vit E/D;	Infection wound site from lymph node removal-left groin	Asthma only with upper respiratory infection-mild intermittent.	hives/rash~Td Adsorbed (no brand name)~~45.00~In Patient|~Influenza (Seasonal) (no brand name)~~72.00~In Sibling		1						1	Dyspnoea; Injection site oedema; Rash pruritic	FLU3~SANOFI PASTEUR~U1134BA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211566	11/04/2003	CA		33		F	11/03/2003	Flu-like symptoms, coughing (like if out of breath), exhausted, tired.  Cough could be worsened by fire.									N	10/28/2003	10/29/2003	1	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Cough; Fatigue; Influenza like illness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211567	11/04/2003	NE	37.0	37		F	11/03/2003	Inside of arm (elbow to armpit) and left side of body with hives and itching.  Have been using medicated powder to stop itching.									N	10/27/2003	10/29/2003	2	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211568	11/04/2003	CO	50.0	50		F	11/03/2003	15:15: Voice became hoarse.  Went home.  She noticed welts above left hip.  Felt throat was closing.  She called clinic at about 16:30, nurse called back.  Recommended to come in, took 4 t. childrens Benadryl.  Saw MD.  She was given Benadryl and a white pill.  She developed more welts was slightly lightheaded.				Y					Y	10/22/2003	10/22/2003	0	NONE	OTH	OTH	Acid blocker	NONE	Allergy: Sulfa			1						1	Dizziness; Dysphonia; Throat tightness; Urticaria	FLU3~SANOFI PASTEUR~U1271AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211583	11/04/2003	NV	62.0	62		F	10/27/2003	3 inch red reaction: red, swollen, hot, feverish, tired.  Used ice packs, Benadryl as needed.									Y	10/15/2003	10/15/2003	0	NONE	PVT	OTH	NONE	NONE	NONE		NV0325	1						1	Fatigue; Injection site erythema; Injection site oedema; Injection site warmth; Pyrexia	FLU3~EVANS VACCINES~765779~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1196M~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211619	11/04/2003	TX	1.33	1	.3	M	10/15/2003	Left thigh very red, warm, swollen approx 24 hours after shot. Child refusing to stand or walk. At office visit still red and swollen but showing signs of improvement with less warmth and swelling.									Y	10/13/2003	10/14/2003	1		PVT	PVT		NONE	Allergy to Omnicef (rash)			1						1	Feeling hot; Injection site erythema; Injection site oedema	DTAP~SANOFI PASTEUR~C1526AA~5~~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1111AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211621	11/04/2003	TX	60.0	60		F	10/25/2003	Extreme chills, drowsy, fatigue. All lasted about 5 hours but still some fatigue 10/5/03.									Y	10/03/2003	10/04/2003	1	NONE	OTH	OTH	Prempro, calcium	NONE	NONE			1						1	Chills; Fatigue; Somnolence	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211626	11/04/2003	GA	62.0	62		M	10/27/2003	Very sick Fri night pain, swelling. Received PPV on 10/24/03 around 10:00 AM. Severe posterior arm pain and headache by PM with swelling. Swelling and pain included upper and lower arm muscle (severe). Joint pain started on 10/26/03. Arm still very swollen 10/28/03. Pt states some better.									U	10/24/2003	10/24/2003	0	NONE	PUB	PVT	B/P meds, Vioxx	NONE	Hypertension			1						1	Arthralgia; Headache; Injection site oedema; Pain	FLU3~EVANS VACCINES~765875~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0988N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211627	11/04/2003	GA	61.0	61		F	10/28/2003	Sat. 1/2 dollar size red area at injection site. By Sunday, four finger size wrapped around arm. Severe headache Sunday with vomiting.									U	10/24/2003	10/25/2003	1		PUB	UNK		NONE	NONE			1						1	Headache; Injection site erythema; Injection site oedema; Vomiting	FLU3~EVANS VACCINES~765875~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0988N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211629	11/04/2003	CA	28.0	28		F	10/24/2003	0.5 ml flu vaccine Aventis Pasteur U1093AA IM left deltoid given approx 12 noon 10/22/03. Rash/itching began 6 PM 10/22/03. Rx'd with antihistamine topical/oral.									Y	10/22/2003	10/22/2003	0		PUB	PUB	Flonase	UNK	Hay fever			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U1093AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211630	11/04/2003	WV	66.0	66		F	10/29/2003	Seven hours after the flu vaccine was administered I experienced extreme dizziness. I was forced to hold to furniture and walls to get to bed. I slept very little and when I awakened I was still somewhat dizzy. The dizziness gradually subsided and was gone by 2:30 PM.									Y	10/23/2003	10/23/2003	0		PVT	PUB	Actonel, Ranitidine	NONE	Sulfa drug			1						1	Dizziness; Insomnia	FLU3~EVANS VACCINES~765955~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211632	11/04/2003	MO	0.5	0	.5	M	10/24/2003	Came into clinic hives on face, upper chest and knee area. Benadryl PO given.									Y	10/24/2003	10/24/2003	0		PVT	PVT			Premature			1						1	Urticaria	DTAP~SANOFI PASTEUR~C1624AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1253AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W1002~3~IM~RL~POLIO VIRUS, INACT. (POLIOVAX)~1|PNC~PFIZER\WYETH~494313~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0211634	11/04/2003	GA	72.0	72		F	10/31/2003	By 5:00 PM upper arm was quite uncomfortable. By 9:00 it was extremely painful. Took Advil (3)- no help at all. Pain extended throughout right arm and into shoulder. Did not sleep at all. Went back to Dr. Examined arm - no redness or swelling but felt shot. My temp at 9 PM on 20th was 100.8, at 7:00 AM was 99.1. Dr took temp and said it was up. I had used moist heat during the night. At home the 29th, I used the moist heat off and on. They gave me a shot in the buttocks while I was at the doctors and to take 2 tablets daily of Biaxin XL 500 mg. Arm and shoulder remained painful throughout the day. Slept in a reclining chair night of 29th. Temp normal. Thursday 30th hand and lower arm pain free. Upper arm and shoulder still quite painful. Couldn't lift anything. Again, slept in recliner as upper arm and shoulder are more painful in flat bed. Follow up on 12/10/2003: Previous reactions were written on the paper I filed on 10/03/03.  this was to and including 10/30/2003.  10/31/03-The arm and shoulder was worse today.  MD gave me ambin so I could sleep.  Did sleep in bed.  11/01-11/02/03- Pain still as bad.  11/03/04-Back to MD.  Was put on a med pack.  Prednisone 10mg, Mon, Tues, Wed, etc until finished and Vioxx 25mg.  By Friday 11/07/03 there was a noticeable difference in the pain.  I could use my arm and shoulder.  It has remained this way.  There still is pain when I lift or use it excessively.  I try to ignore it!  I have finished the Vioxx and am anxious to see what happens now.  At night, if I roll over on that arm, it still wakes me up.  I don't feel I should even take another pneumonia shot!  I have had pneumonia 3 times in the past 7 years-but-it wasn't as this experience has been.  Can I ever expect this arm to be back to normal?				Y					N	10/28/2003	10/28/2003	0		PVT	OTH			Seasonal sinus problems			1						1	Pain; Pyrexia; Sleep disorder	FLU3~SANOFI PASTEUR~U1132AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0944N~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211635	11/04/2003	AL	33.0	33		F	10/16/2003	Received vax at 8:20 AM. By 8:50 c/o pain at site then radiating down arm. Progressed to numbness in both arms, then legs. C/o dizziness, flushing, progressed to SOB. Received Epinephrine 1:1000 0.3ml SQ. Paramedics summoned. To ER.				Y					Y	10/09/2003	10/09/2003	0		OTH	PUB	UNK		Multiple allergies, allergy shots 2 x/week		AL0326	1						1	Dizziness; Dyspnoea; Flushing; Hypoaesthesia; Pain	FLU3~EVANS VACCINES~765181~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0211639	11/04/2003	PA	87.0	87		M	10/29/2003	Itching left arm - elbow to wrist and inside of forearm is bright red and warm; both ankles red and swollen. These symptoms started on 10/28/03, 13 days after flu shot. Treated with 2cc Kenalog in RD on 10/28/03; on 10/29 given Diprolene 0.1% cream tid to area.				Y					Y	10/15/2003	10/28/2003	13		PUB	UNK	Coumadin, Beccaroia(?), Maxide, Zocor, Avandia, KCl	NONE	Sulfa allergy. DM, CVA, Hypertension, right carotid stenosis, prostate cancer, anemia		PA0322	1						1	Erythema; Feeling hot; Oedema peripheral; Pruritus	FLU3~SANOFI PASTEUR~U1088AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211643	11/04/2003	MI	65.0	65		F	10/17/2003	Approx 8 PM 10/16/03 right arm (RD) area began itching, some redness and swelling noticed. 9 PM took Advil. Reports sleepless night due to pain. Repeated Advil 8 AM 10/17/03. 10/17/03 4:30 PM called HD to request swelling now down to 1 1/2 above elbow joint with swelling to medial site of arm as well. Hot to touch. Plans to call PMD yet today. 10/20/03 TC to pt - seems better, swelling down, used ice packs and Advil.									Y	10/16/2003	10/16/2003	0		PUB	UNK	Prilosec, Utracept	NONE			MI2003053	1						1	Injection site erythema; Injection site oedema; Injection site warmth; Insomnia; Pruritus	FLU3~SANOFI PASTEUR~U1287AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0872M~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211646	11/04/2003	MN	31.0	31		F	10/23/2003	As the influenza shot was placed in arm, left arm and hand went numb. My hand remained numb and tingled for an hour and a half, then my left arm started improving. Still has numbness on forearm and base of palm. Large egg shaped lump around injection site.									U	10/22/2003	10/22/2003	0	NONE	PUB	UNK	BCP, Differingel	NONE	NKA		MN03007	1						1	Hypoaesthesia; Injection site mass	FLU3~SANOFI PASTEUR~U1267AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211647	11/04/2003	MN	50.0	50		F	10/23/2003	Sore throat and chills started about 2 days after shot (10/18). Temp not taken. Cough began 10/21. Had neg rapid strep test, culture not back yet. Bruise at injection site.									N	10/16/2003	10/18/2003	2	Strep rapid test - negative. Culture not back yet.	PUB	PUB	ASA, Prempro	NONE	NONE		MN03006	1						1	Chills; Contusion; Cough; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U125AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211651	11/04/2003	CT	29.0	29		M	10/31/2003	Within 15-30 minutes of receiving injection, client c/o headache and stiffness in right arm, was seen in ER on 10/27/03. Prescribed Vicodin.				Y					N	10/27/2003	10/27/2003	0	NONE	PUB	PVT	Milk of magnesia, Clarinex	NONE	Scoliosis, hx of headaches; allergies to perfume, dust, ibuprofen	temp~DTaP (no brand name)~3~1.00~In Patient		1						1	Headache; Musculoskeletal stiffness	FLU3~EVANS VACCINES~765413~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0211653	11/04/2003	GA	71.0	71		M	10/29/2003	10/29/03 Pt stated that the night 10/27/03 after shot right arm began to ache and swell. Next morning arm was hurting worse and swollen more. Area red and swollen above elbow and below elbow, warm to touch. Instructed to keep warm towels on arm and keep taking Motrin. Understanding to RTC or ER if condition gets worse.									Y	10/27/2003	10/27/2003	0	NONE	PUB	PUB	BP med, Motrin, Benadryl, breathing machine and Albuterol	NONE	NKDA			1						1	Feeling hot; Injection site oedema; Pain	FLU3~EVANS VACCINES~765704~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0869N~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211655	11/04/2003	WA	39.0	39		F	10/28/2003	Generalized arthralgias. The follow up received on 12/23/03 states arthralgia-joint pain, total body. No fever, no muscle pain, h/a 2 days post admin. of flu vaccine. Prednisone-40mg qd x 5 days.				Y					Y	10/23/2003	10/25/2003	2	NONE	PUB	PUB		NONE	NONE		WA031976	1						1	Arthralgia; Headache; Pain	FLU3~EVANS VACCINES~76575.~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0211658	11/04/2003	NV	57.0	57		F	10/23/2003	Chills, painful left arm, extreme aching and pain throughout body, shaking, heavy chest.									Y	10/19/2003	10/20/2003	1		PUB	UNK		NONE	NONE			1						1	Chest pain; Chills; Pain; Tremor	FLU3~SANOFI PASTEUR~U1069AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211660	11/04/2003	TX	50.0	50		F	10/24/2003	Became very ill within 24 hours. Flu-like symptoms. Arm swollen and red.									U	10/20/2003	10/20/2003	0	NONE	OTH	UNK						1						1	Influenza like illness; Injection site erythema; Injection site oedema	FLU3~EVANS VACCINES~765957~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~9028912~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211667	11/04/2003	IA	55.0	55		F	10/18/2003	Red, swollen, sore at injection site. Fever. Aches, painful muscles. She took Tylenol and rest. Recovered in 2-3 days per husband.									Y	10/03/2003	10/04/2003	1		MIL	UNK	Lipitor, Effexor, Sinenet, Aciplex	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Myalgia; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1074AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1079M~2~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211668	11/04/2003	IL	67.0	67		F	10/24/2003	Right arm below injection site red, warm, swelling 4 x 5. Pt did not inform provider right mastectomy. MD notified and appt made for 10/24/03. Benadryl and Tylenol given.									Y	10/23/2003	10/23/2003	0		PUB	PVT			PCN, sulfa, adhesive, Td			1						1	Feeling hot; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1126AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0256N~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211669	11/04/2003	OK	78.0	78		F	10/24/2003	Pt had flu-like symptoms post immun/vaccination that lasted 4 days and ended in a macular rash over trunk and bilat lower extremities.									U	10/13/2003	10/15/2003	2		PUB	PUB	Macrodantin	UTI	Anxiety			1						1	Influenza like illness; Rash macular	FLU3~SANOFI PASTEUR~U1092AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211671	11/04/2003	CO	49.0	49		F	10/27/2003	Began to itch all over body with back and right shoulder worse. Took 50 mg Benadryl at 7:00, 8:30 and 11:30 PM. Had visible hives on back, right shoulder. No fever but did have diarrhea 9x in 6 hours. Continued to take Benadryl for 2 days due to itching and rash.									Y	10/22/2003	10/22/2003	0	NONE	OTH	PUB	Paxil		Compozine, Toredal, Doxicycline			1						1	Diarrhoea; Pruritus; Urticaria	FLU3~EVANS VACCINES~765707~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211672	11/04/2003	MI	64.0	64		F		Left arm upper bruised and painful on 10/21/03. On 10/22/03 developed a hematoma.				Y					Y	10/21/2003	10/22/2003	1		PVT	OTH						1						1	Contusion; Haematoma; Pain	FLU3~SANOFI PASTEUR~U1080AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0863N~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211673	11/04/2003	RI	51.0	51		F	10/27/2003	Had shot Wed., 10/22/03. Thurs AM (10/23) experienced mild sore throat, progressive weakness, joint and muscular pains, chills (fever), slight cough, malaise and lethargy, poor appetite. 4 days severe distress. By Oct 27 improving.									Y	10/22/2003	10/23/2003	1	NONE	PUB	PVT	NONE	NONE	NONE			1						1	Arthralgia; Asthenia; Cough; Decreased appetite; Lethargy; Malaise; Myalgia; Pharyngolaryngeal pain; Pyrexia	FLU3~EVANS VACCINES~765138~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211676	11/04/2003	WI	21.0	21		F	10/27/2003	Site became red, itchy and warm on 10/25/03 and remains warm and red on 10/27/03.									Y	10/24/2003	10/25/2003	1		PVT	PVT		NONE				1						1	Feeling hot; Injection site erythema; Pruritus	FLU3~EVANS VACCINES~765958~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211677	11/04/2003	IN	42.0	42		F	10/24/2003	7 1/2cm erythematous swelling with warmth. Tenderness at site of injection.									Y	10/22/2003	10/23/2003	1		PVT	PVT		NONE	NONE			1						1	Feeling hot; Injection site erythema; Injection site oedema; Pain	FLU3~SANOFI PASTEUR~U1079AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211678	11/04/2003	KS	47.0	47		F	10/27/2003	Red area around injection site, warm to touch, faded away just as quickly as showed up.									Y	10/24/2003	10/26/2003	2	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Feeling hot; Injection site erythema	FLU3~SANOFI PASTEUR~U1266AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211679	11/04/2003	KS	48.0	48		F	10/27/2003	Headache and nausea for 3 days after getting vaccine.									Y	10/23/2003	10/24/2003	1	NONE	PUB	OTH	NONE	NONE	NONE			1						1	Headache; Nausea	FLU3~SANOFI PASTEUR~U1266AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211681	11/04/2003	CO	64.0	64		F	10/28/2003	Two hours later almost passed out. Everything black with sparks, nausea, weak, bowel movement, felt like vomiting. Cold compresses applied, drank a coke, continued to feel weak and uneasy. Left work, rested at home. Vomited during the night about 6 times (a lot!). Slept and read the next day. Up and about the 2nd day after.									Y	10/24/2003	10/24/2003	0		OTH	OTH	Hyzaar	NONE	NONE			1						1	Asthenia; Dizziness; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211682	11/04/2003	NV	81.0	81		M	10/26/2003	Had flu vaccine and pneumococcal vaccine in right arm. Next day arm swelled up and became red down past elbow. Called and was directed to call my own doctor's office. Nurse advised iced compress be applied to stop swelling and redness. I complied for 2 days and swelling and redness left me. Seems OK now.									Y	10/14/2003	10/15/2003	1	NONE	PUB	OTH		NONE	Ragweed allergy			1						1	Injection site erythema; Injection site oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0211683	11/04/2003	NJ	63.0	63		M	10/28/2003	Swollen arm pain for 2 days. Redness for 6 days.									Y	10/21/2003	10/21/2003	0		PUB	UNK		NONE				1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1078AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0256N~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211685	11/04/2003	MO	43.0	43		F		MVA one hour post flu vaccine. Possible black out spell.									Y	10/22/2003	10/22/2003	0	CBC, sed rate	PVT	PVT		NONE	NONE			1						1	Loss of consciousness	FLU3~EVANS VACCINES~765138~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211689	11/04/2003	CA	4.0	4		F	10/25/2003	Cellulitis left deltoid area.									U	10/23/2003	10/24/2003	1	NONE	OTH	PVT	NONE	NONE				1						1	Cellulitis	FLU3~SANOFI PASTEUR~U1080AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211690	11/04/2003	MS	66.0	66		F	10/20/2003	10/10 - Pneumonia and Flu administered 10/17 - Called HD said rt arm numb, instructed her to go to see PMD				Y					Y	10/10/2003	10/17/2003	7	None	PUB	PUB	unknown	none	unknown		MS03090	1						1	Hypoaesthesia	FLU3~SANOFI PASTEUR~U1094AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0735M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211691	11/04/2003	MO	51.0	52		F	10/16/2003	started breaking out at 3:30 - noticed this when patient came home from store at 4:05.  Has rash on arms, fac red and slightly warm.  Rash has started on back 4:10 Benadryal 4:15 rash started to fade.  4:20 instructed patient on use of benadryal. Will follow up with patient next day.									Y	10/15/2003	10/15/2003	0		UNK	PUB					MO200390	1						1	Feeling hot; Flushing; Rash	FLU3~SANOFI PASTEUR~U1074AA~4~ID~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211692	11/04/2003	MO	71.0	71		F	11/04/2003	Guillain-Barre Syndrome. The hospital discharge summary received on 12/15/03 states apnea/respiratory failure.	Y	10/31/2003			Y	8			N	10/14/2003	10/23/2003	9		PVT	PVT		None	Type 2 Diabetes, COPD, Hypertension, Hyperlipidemia, Peripheral Vascular Disease, TIA, osteoarthritis.			1						1	Apnoea; Guillain-Barre syndrome	FLU3~SANOFI PASTEUR~U1255AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0211693	11/04/2003	SC	57.0	57		M	11/04/2003	INJECTION SITE: swollen with blister' within same day - scaly rash 1 from injection site started same day - still has rash at present (approx 2 weeks from injection date)									Y	10/16/2003	10/16/2003	0		PUB	UNK		NONE	No known allergies, degenerative disc disease, COPD		SC0342	1						1	Injection site swelling; Injection site vesicles; Rash	FLU3~SANOFI PASTEUR~U1260AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211695	11/04/2003	MI	23.0	23		F	11/04/2003	Vaccine given at 3:15pm.  At 3:50 she c/o feeling warm or flushed and her back itched.  Upper back had hand sized area that was red.  B/P 120/82.  Five minutes later she vervbalized feelings of anxiety and concern over her asthma.  C/o SOB.  0.5 cc Epinephren given sub q at 4:05.  Dose repeated at 4:25 and 911 called despite protest of client.  4:30 transported to ER.				Y					Y	10/30/2003	10/30/2003	0		PUB	PVT						1						1	Anxiety; Asthma; Erythema; Feeling hot; Flushing; Pruritus	FLU3~EVANS VACCINES~765415~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0211778	11/04/2003	MI	21.0	22		F	11/04/2003	Vaccine given at 3:20pm.  At 3:45pm she c/0 nausea.  B/P - 120/78, face mildly flushed.  Refused ambulance.  4pm c/o chest tightness.  Then denied it.  c/0 nausea, lightheadedness, dizziness.  Mother arrived and client ambulated to car without help.  Agreed to go to ER.									Y	10/30/2003	10/30/2003	0	Found out the next day that client did go to doctor and that she is fine.  Still experiencing nausea	PUB	PVT						1						1	Chest discomfort; Dizziness; Flushing; Nausea	FLU3~EVANS VACCINES~765415~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211779	11/04/2003	DC	55.0	55		M	11/04/2003	General malaise from day 2 through 4.  Severe sore throat day 5 through 7.  Sinus congestion  day 7 through 10. Treatment: Tylenol. No fever. No reaction at injection sight.									Y	10/20/2003	10/21/2003	1	None	PUB	PUB	None	None	None			1						1	Malaise; Nasal congestion; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U1089AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211780	11/04/2003	IL	85.0	85		F	11/04/2003	states injection site for flu vaccine hurt since it was given. firmness at injection site that eve. redness the next day, under the arm not at the site. still red today, approx 6 redness under left arm. referred to dr.				Y					U	10/31/2003	10/31/2003	0		UNK	PUB	cardizem daily, arthrotec daily, tylenol					1						1	Injection site erythema; Injection site induration; Injection site pain	FLU3~SANOFI PASTEUR~u1092aa~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0287n~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211783	11/04/2003	KY	66.0	66		F	11/04/2003	Patient called today (11/04/2003) states that approximately one week after she received her flu shot her arm began to hurt so badly that she had to go to the Emergency Room and to her family doctor.  She was told by her doctor that she had a hematoma where she got her shot (per patient)				Y					U	10/06/2003	10/13/2003	7	none	PUB	PUB	Unknown	Unknown	Unknown			1						1	Haematoma; Pain	FLU3~SANOFI PASTEUR~U1140AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211784	11/04/2003	NJ	60.0	60		F	11/04/2003	Indurated injection site.  Facial urticaria.									Y	10/27/2003	10/28/2003	1		PUB	PVT		none	none			1						1	Injection site induration; Urticaria	FLU3~EVANS VACCINES~765851~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211785	11/04/2003	NJ				F	11/04/2003	Painful left axilla. No swelling, erythema, or induration noted.									Y	10/28/2003	10/29/2003	1		UNK	UNK	unknown	none	none known			1						1	Pain	FLU3~EVANS VACCINES~765851~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211716	11/05/2003	IL	4.0	4		M	11/04/2003	Received influenza vaccine on 10/17/03 approximately 12:00. By evening the mother states that repetitive eye blinking started to occur over the next 2 days. Episodes worsened and became more frequent. He was then brought to the ER on 10/20/03 for evaluation and treatment. He was then admitted to the hospital for work up to rule out seizures. The ER/discharge summary received on 11/7/03 states movements involuntary and tic. 60-day follow up on 02/10/04: It is unknown if the pt recovered from adverse events. Since 10/17/03, pt has been evaluated by a neurologist. Workup has included CT scan, MRI and sleep study. He is now being treated for Tourettes and on Risperdal. It is felt that he may have had an underlying disorder at the time of the influenza vaccine which then aggravated his disorder.				Y	Y	1			N	10/17/2003	10/17/2003	0	CBC; Amino and organic acids; ASO; anti-DNA ASL; Sed rate; Complete chemical panel; EEG; MRI. MRI wnl, EEG wnl.	PVT	PVT	NONE	NONE	ADHD, developmental delay			1						1	Dyskinesia; Eye disorder; Muscle twitching	FLU3~SANOFI PASTEUR~U1079AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0211717	11/05/2003	FL	42.0	42		F	10/29/2003	Within minutes after receiving vaccine experienced flushing of face and upper chest. Complained of feeling funky. Was taken to ER after approximately 15 minutes with improvement. In ER she experienced chest pain, SOB, and nausea. After receiving IV Benadryl and Decadron without complete resolution of symptoms, she was admitted. The discharge summary received on 3/23/04 states restrictive lung disease.				Y	Y	4			Y	10/22/2003	10/22/2003	0	Glucose elevated (Patient is diabetic). Blood sugar elevated, lipids elevated.	PUB	PVT	Glucophage; Amaryl; Actose; Diavan; Corgard; Lasix; Zoloft; Multivitamin	NONE	Penicillin; Codeine; Radiographic dyes; Compazine; Demerol; Diabetes; One kidney; Brain tumor/cyst; Uterine disorder; hypertension; hypothyroid			1						1	Blood glucose increased; Chest pain; Dyspnoea; Flushing; Lipids increased; Lung disorder; Malaise; Nausea	FLU3~EVANS VACCINES~765499~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0211720	11/05/2003	FL	31.0	31		F	10/30/2003	10/3/03 received vaccine. Followed up with doctor at work the following Monday. 2 weeks later pain worse; went back to work. Physician told possible nerve damage. One week ago, severe pain; went to own physician. The medical records received on 12/31/03 states numbness, multiple sclerosis, and demyelinating plaque. 60-day follow up on 01/12/04: The vaccine recipient is unknown to have recovered from the adverse events that were reported for this vaccination.  You may want to follow up with her employer.  I sent you their information when I reported.  She has not been back to our facility.					Y				U	10/03/2003	10/03/2003	0	MRI abnorm.	OTH	OTH	Synthroid; Prenatal vitamins	NONE	Erythromycin; PCN; Sudafed; Naprosen; Soma; sciatica; Bell's palsy; peptic ulcer disease; depression; pilonidal cyst; hypothyroid			1						1	Hypoaesthesia; Laboratory test abnormal; Multiple sclerosis; Nerve injury; Neuropathy; Pain	FLU3~SANOFI PASTEUR~U1134BA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0211721	11/05/2003	MO	1.28	1	.3	F	11/04/2003	Fever day after immunization. Gone that night, but then developed moaning and grunting. Went to ER; looked shocky and then arrested. Died several hours later despite repeated resuscitation efforts. The autopsy received on 11/11/03 states pseudomomas sepsis. The autopsy report received on 2/4/04 states shock and cholangitis.	Y	10/23/2003	Y	Y	Y				N	10/21/2003	10/22/2003	1	Blood cultures; Autopsy report; Pseudomonas sepsis (possible infected liver cyst).	PVT	PVT	Norvase; Vasotec; Lasix		Polycystic Kidney Disease; Hypertension; Previous E. Coli bacteremia			1						1	Bacterial infection; Cholangitis; Grunting; Laboratory test abnormal; Pyrexia; Sepsis; Shock	DTAP~GLAXOSMITHKLINE BIOLOGICALS~616A2~4~IM~LL~DTAP (INFANRIX)~1|FLU3~PFIZER\WYETH~4020017~2~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HIBV~PFIZER\WYETH~494759~4~IM~LL~HIB (HIBTITER)~1	USA	Results in Death	Influenza
0211722	11/05/2003	SC	31.0	31		F	10/27/2003	Allergic reaction to smallpox vaccination. Red streak going from vaccine area to the underarm. Keflex for skin infection.				Y					Y	10/14/2003	10/23/2003	9		MIL	MIL	Aciphex, Ortho Novum	NONE	NONE			1						1	Cellulitis; Hypersensitivity	ANTH~EMERGENT BIOSOLUTIONS~FAV076~6~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1147AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020071~1~~~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~U1203~4~~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0211723	11/05/2003	MN	36.0	36		M	10/26/2003	Anthrax immunization site swollen, red, 70cm, warm to touch for 3 days.									Y	10/23/2003	10/24/2003	1		MIL	MIL	NONE	NONE	NONE			1						1	Feeling hot; Injection site erythema; Injection site oedema	ANTH~EMERGENT BIOSOLUTIONS~FAV078~4~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1266AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211724	11/05/2003	TX	68.0	68		M	11/04/2003	On 10/23: temp 101 F and body aches. On 10/24: 4 diameter red area on arm. On 10/26: All symptoms in remission.									Y	10/22/2003	10/23/2003	1	NONE	PUB	OTH	For blood pressure and thyroid	NONE				1						1	Injection site erythema; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1123AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0257N~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211725	11/05/2003	SC	55.0	55		F	11/03/2003	Received flu vaccine on Fri 10/24/03 and c/o Sat with flu-like symptoms and Sunday developed a rash, felt like pins and needles coming out of her arms.									Y	10/24/2003	10/25/2003	1		PVT	PVT		NONE				1						1	Influenza; Rash	FLU3~EVANS VACCINES~765873~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211726	11/05/2003	VA	35.0	35		F	11/04/2003	Vaccine given 11/3/03. States by 5 PM, diarrhea, nausea, dry heaves, malaise, headache, arms and shoulder ache. Continues on 11/4/03. No temp.									N	11/03/2003	11/03/2003	0	None at this time	MIL	OTH		NONE	Shellfish, e-mycin			1						1	Diarrhoea; Headache; Malaise; Nausea; Pain	FLU3~SANOFI PASTEUR~W147AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211727	11/05/2003	NY	49.0	49		F	11/04/2003	Severe fatigue, headache-severe (+) painful neck, back.  Both wrists was shaking, chills, malaise.  Temperature 100.6.									U	10/31/2003	10/31/2003	0	CBC/ESR/CMP/RF/ANA	PVT	PVT	NONE	NONE	NONE/Allergic to sulfa drug			1						1	Fatigue; Headache; Malaise; Pain; Pyrexia; Tremor	FLU3~EVANS VACCINES~765178~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211733	11/05/2003	OH	49.0	49		M	10/28/2003	Telephone call from client: Nickel to eraser size hives around pneumonia injection site (6-7).  Doctor said to take Benadryl and not to ever repeat pneumonia shot.									Y	10/25/2003	10/25/2003	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1098AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~107AM~2~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211736	11/05/2003	OR		53		F	10/30/2003	Swelling and itching at both eyes.  Right eye almost swollen shut.  2 inch purple bruise at injection site.									Y	10/22/2003	10/22/2003	0	NONE	PUB	PUB	Zoloft 100mg daily	NONE	Mild allergy to eggs, has tolerated flu vaccines well in past		OR200343	1						1	Eye oedema; Pruritus	FLU3~SANOFI PASTEUR~U1093AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211738	11/05/2003	WA	68.0	68		M	10/30/2003	Vaccine 10/28/2003-Pneumococcal sore ness the same day, painful could not lay on right arm.  10/29 @ 17:00: noticed redness elbow to mid upper arm, very warm circulation good.  Advised to see MD if becomes worse and to call tomorrow to report.									U	10/28/2003	10/28/2003	0	NONE	PUB	PVT	NONE	NONE	NONE			1						1	Erythema; Feeling hot; Injection site pain	FLU3~EVANS VACCINES~765753~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0675M~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211740	11/05/2003	MD	41.0	41		F	11/03/2003	11 AM pt reported feeling throat tightness, increased dry cough, raspy voice. Pt states she took Mestinon tablet. Administered Benadryl 25mg PO per adult Influenza vaccine (1105). Dr notified and examined pt. BP 122/76 P 72/min, oxygen sat RA 99%. 1107 Am administered Epinephrine (1:1000) 0.3cc SQ in R arm. Pt alert denies SOB. At 11:20 am pt reports feeling much better, no throat tightness. Pt discharged with Rx for Prednisone taper and instruction.				Y					Y	11/03/2003	11/03/2003	0	NONE	PVT	OTH	QVAR, Singulair, Nasarel; Zantac; Ti radol; Mextrom		Myasthenia gravis; asthma			1						1	Cough; Throat tightness	FLU3~SANOFI PASTEUR~U1147AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211744	11/05/2003	FL	55.0	55		F	10/29/2003	10/20/2003: Bright white patches tip right thumb, 3 digits left hand, patches palm left hand; 10/21/2003: Tingling both hands; 10/22/2003: Tingling hands, both facial cheeks, and lower lips sporadic tingling arms, legs. 10/23/2003: Glove effect both hands upward to wrist (tingling).   No symptoms.  Prednisone 20mg thursday 10/23/2003; Prednisone 10 mg Friday 10/24/2003.  Physician diagnosis: Polyneuritis.				Y					Y	10/16/2003	10/20/2003	4	10/23/2003: CBC, ANA, Sedimentation rate: all negative	OTH	OTH	UNK	NONE	Allergy IVP dye, NKMC			1						1	Paraesthesia; Polyneuropathy	FLU3~SANOFI PASTEUR~U1081AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211745	11/05/2003	WI	41.0	41		F	10/30/2003	Redness-dime sized area at injection site, noticed shortly after receiving injection.  By the AM of 10/30/2003, the redness had increased to 1 by 2 inches, slightly swollen, warm to touch.  Painful when touched.  Took 2 Tylenol this AM-still sore.  Able to function ok.									Y	10/29/2003	10/29/2003	0	NONE	OTH	PUB	Oxycontin for back injury	NONE	Back-related injury			1						1	Feeling hot; Injection site erythema; Injection site oedema; Injection site pain	FLU3~EVANS VACCINES~765797~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211746	11/05/2003	CT	41.0	41		F	10/31/2003	5 hours after injection, complained of stinging at site.  Ice applied.  1 hour later, 25 cent size reddened area on left deltoid.  WTT.  Ice applied again.									Y	10/31/2003	10/31/2003	0	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Injection site erythema; Pain	FLU3~EVANS VACCINES~765483~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211753	11/05/2003	WI	60.0	60		M	10/31/2003	Pt developed a very large area of erythema (redness) measuring approx 14 to 16 long and approx 4 to 5 wide. Area extended from in front of armpit to below elbow on inner aspect of arm. No itching. Arm a little sore. Was seen by PMD on 10/31/03, treated with Allegra, ice to area and Tylenol.				Y					Y	10/29/2003	10/30/2003	1		PVT	OTH		NONE	Bee allergy			1						1	Injection site erythema; Pain	FLU3~SANOFI PASTEUR~U1148CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0988N~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211756	11/05/2003	CA	97.0	97		F	10/27/2003	Had influenza vaccine. Seen by MD for left outer arm 7 x 7cm erythema with warmth at site and 5 papules. Pt states, received injection same arm, left deltoid area. Seen by MD 10/24/03.									N	10/21/2003	10/22/2003	1		OTH	UNK						1						1	Feeling hot; Injection site erythema; Rash papular	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211757	11/05/2003	WA	31.0	31		F	10/30/2003	Softball size raised area and blotchy. Redness on arm and neck. Area very hot and sore. Hurts to lift arm.									U	10/28/2003	10/28/2003	0		OTH	UNK		NONE	NONE			1						1	Erythema; Injection site oedema; Injection site warmth; Pain; Rash maculo-papular	FLU3~SANOFI PASTEUR~U1133AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211760	11/05/2003	WV	42.0	42		F	10/29/2003	Local swelling and redness and mild tenderness at pneumovax injection site.									U	10/28/2003	10/28/2003	0		PVT	PVT		NONE	Penicillin			1						1	Injection site erythema; Injection site oedema; Pain	FLU3~EVANS VACCINES~765143~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0740N~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211761	11/05/2003	NY	4.0	4		M	10/24/2003	Child seen by PNP for 4 year old well visit and given DTaP in left arm. Parent returned to office about 10 minutes after shot given crying due to pain at site. Hives, erythema in 3 diameter circle surrounding injection site. Site tender, no swelling and slight erythema about 1/2 at IPV site. Benign flu site. Ice applied. Advil given. Parent informed to give Benadryl if erythema increased.									Y	10/23/2003	10/23/2003	0		PVT	PVT	Flovent, Albuterol	NONE	NONE			1						1	Agitation; Crying; Injection site erythema; Pain; Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~616A2~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1089AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W0816~UNK~IM~RA~POLIO VIRUS, INACT. (POLIOVAX)~1	USA		Influenza
0211763	11/05/2003	NM	55.0	55		F	10/22/2003	Itching at injection site, swelling at injection site, pain at injection site.									Y	10/21/2003	10/21/2003	0		PUB	PUB	Prempro	NONE	Seasonal allergies treated with OTC meds			1						1	Injection site oedema; Pain; Pruritus	FLU3~SANOFI PASTEUR~U1271AA~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211764	11/05/2003	GA	2.0	2	.3	M	10/28/2003	Red swollen right leg, non tender.									U	10/24/2003	10/27/2003	3	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1097AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~494313~4~~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0211765	11/05/2003	KY	51.0	51		F	10/26/2003	Bruising 2 x 2 with redden hot area around injection site. Redness and heat remained 3-4 days, pain from inflammation for 3-4 days.									Y	10/18/2003	10/18/2003	0	NONE	PVT	PVT		NONE	HTN, increased lipids, obese	same~Influenza (Seasonal) (no brand name)~~50.00~In Patient		1						1	Contusion; Injection site erythema; Injection site inflammation; Injection site warmth; Pain	FLU3~EVANS VACCINES~265669~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211767	11/05/2003	MA	14.0	14		M	10/29/2003	Pt received flu vaccine in office in am-went to school. Felt sweaty and weak in school. Had conference in ? personality changed-was ? to mom. Then developed T 101 degrees briefly, vomited later with headache. Temperature headache and vomiting resolved. On 10/29 he was fine and went to school. Personality returned to normal. He was apologetic for his ? behavior.									Y	10/28/2003	10/28/2003	0	NONE	PVT	PUB	NONE	NONE	Allergies to amoxicillin, Ceclor, Clindamycin, Ceftriaxone, Erythromycin			1						1	Asthenia; Headache; Hyperhidrosis; Personality disorder; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1145AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211768	11/05/2003	GA	81.0	81		M	10/22/2003	L arm red and warm to touch. Area approx size of golf ball noted in the inner aspect of L arm above elbow area.				Y					U	10/21/2003	10/22/2003	1		PUB	PVT		NONE				1						1	Erythema; Feeling hot	FLU3~EVANS VACCINES~765710~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0604M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211770	11/05/2003	TX	63.0	63		F	10/28/2003	Several hours after vaccine, pt had a red bard around arm. The next day she had  hives all over her body. She called a 24 hr pharmacy and was told to take Benadryl. She made an appt with her Dr. in the morning and was prescribed a Medrol dose pak.				Y					Y	10/17/2003	10/17/2003	0		OTH	OTH						1						1	Erythema; Urticaria	FLU3~SANOFI PASTEUR~U1079AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0883N~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211771	11/05/2003	CA	49.0	49		M	10/29/2003	Claims felt drained on the afternoon following vaccination with severe headache lasting 19 hrs. Seen by PMD for headache.				Y					Y	10/21/2003	10/21/2003	0	NONE	OTH	PVT	NONE	UNK	UNK			1						1	Asthenia; Headache	FLU3~SANOFI PASTEUR~U1069AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211772	11/05/2003	MO	45.0	45		F	10/31/2003	On 10/22/03 a representative from the dept came to schools, where I work to administer flu vaccination at approximately 12:30pm. Around 8 that evening, I noticed my feet were starting to swell. By Thursday morning, October 23, my feet were swelling quite a bit and my knees started aching a lot. As the day went on my knees and calves were hurting a lot-a tight achy feeling. By 8pm Thursday evening, my hands started swelling. During the night around 2am (Fri morning), I awoke with tremendous pain in both hands. When I got up at 6am, my finger were completely swollen that I was unable to close my fists. My complete hands, from the wrists down, were so swollen that they were aching severely. I called the dept at 8am Friday morning to ask them if it could be an allergic reaction. The nurse informed me that they've giving 1500 flu shots and have not had any allergic reactions. She said that it was very unlikely that it was an allergic reaction. At 10am Friday, October 25, I went to my dr's office and saw a nurse practitioner who asked me several questions about the vaccination, but then proceeded to run blood tests checking for lupus, as well as my sodium and potassium levels. All blood tests were negative. The nurse practitioner put me on Lasix to try and reduce the swelling. By Saturday morning, October 26, there was no relief in the swelling. The pain from the swelling in my hands was very severe. I called my doctor's office again and spoke with the doctor on call. I explained everything to him. He told me to take Benadryl and Pepcid together. If it was an allergic reaction, the swelling should go down after a few doses. By Sunday evening, October 26, all the swelling was completely gone. My hands and legs continued to ache a little through Monday morning. But there was much relief. On Monday, October 27, I went back to my regular doctor out of concern of all the blood tests run and the whole incident. After checking my records, my doctor informed me that my swelling was caused by the flu shot. He told me that it might take a few more days to get completely out of my system. He also informed me to notify the dept or the number listed (VAERS). On Tuesday, October 28, I started getting nausea and a bad headache-throwing up all day Tuesday, Tuesday night and part of Wednesday. It was Thursday, October 30, before I could go back to work and feel better. I'm not sure if the vomiting and headache had anything to do with the vaccination.				Y					Y	10/22/2003	10/22/2003	0	Blood tests to r/o lupus and other diseases	OTH	PVT		NONE	NONE			1						1	Headache; Hypersensitivity; Nausea; Oedema peripheral; Pain; Vomiting	FLU3~EVANS VACCINES~765797~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0211773	11/05/2003	OR	66.0	66		F	10/30/2003	Approx 6 hrs post injection pt stated sudden onset SOB. No other symptoms. Denied N/V, rash, headache or fever at this time. Used albuterol inhaler-symptoms resolved. Approx 2 am woke up with fever (did nto take temp) muscle aches Ibuprofen helped. Duration pain, fever 2 days.									Y	10/22/2003	10/22/2003	0	NONE	PUB	PVT	Alberterol inhaler, Synthroid, BP med		environmental allergies, astma, sarcooidosis.			1						1	Dyspnoea; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1091AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211775	11/05/2003	MI	20.0	20		F	10/28/2003	Right upper arm pain, elbow to neck swelling, heat in area of injection.				Y					Y	10/27/2003	10/27/2003	0	NONE	PVT	PVT	Triphasil	NONE	NONE			1						1	Injection site warmth; Oedema; Pain	FLU3~SANOFI PASTEUR~U1133AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211776	11/05/2003	IL	51.0	51		M	10/27/2003	Acute nausea, fever and headache 3 hours after vaccination. Fever up 2 degrees until 5 AM 10/21/03. All of this could have been due to immune system response!									Y	10/20/2003	10/20/2003	0		OTH	OTH	Protonix	NONE	NONE	headache~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Headache; Nausea; Pyrexia	FLU3~EVANS VACCINES~765876~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211789	11/05/2003	MO	49.0	49		M	10/29/2003	Redness around site about 5, eventually went around arm. No fever, SOB, pain. Later felt hot and headache, arm sore. Reported 10/29/03.									Y	10/28/2003	10/29/2003	1		OTH	PVT		NONE	NONE			1						1	Headache; Injection site erythema; Injection site warmth; Pain	FLU3~SANOFI PASTEUR~U1079AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0864N~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211791	11/05/2003	VA	50.0	50		F	10/31/2003	Pt was given flu vaccine at approximately 10 AM. She noted an intense rash around 4 PM. Advised pt to take Benadryl and go to emergency room if condition changed.									U	10/30/2003	10/30/2003	0		OTH	PVT						1						1	Rash	FLU3~EVANS VACCINES~765483~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211794	11/05/2003	MN	44.0	44		F	10/30/2003	15 minutes after vaccine was given, right hand developed a hive. It itched and got bigger. After I got home, I called the clinic. When they called back, hive was getting better.									Y	10/29/2003	10/29/2003	0		PVT	PVT	Wellbutrin SR	NONE	NONE			1						1	Pruritus; Urticaria	FLU3~EVANS VACCINES~765502~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211795	11/05/2003	SD	71.0	71		F	10/29/2003	Pt states she started symptoms 9:00 PM 10/28/03 vomiting, body pain aching down arms to fingertips to top of head. Increased temp 101 at night all night. No dypsnea, no rash, no swelling of left arm. Pt states primary complaint stomach pain, body pain, left arm pain, no diarrhea. Provider noted mild edema left arm, left eye swollen red. Pt sent with Allegra 60mg and Benadryl 50mg prn. Pt to take Tylenol prn for pain. Flu pack 10/31/03 13:00. Pt's condition improved.				Y					Y	10/28/2003	10/28/2003	0	Pulse oximetry 02 sat 93, Rmar	PVT	PVT	Prilosec, Hzyaar, Norvasc	NONE	ASA, PCN; HTN, hyperlipidemia, GERD			1						1	Abdominal pain upper; Eye oedema; Injection site oedema; Pain; Pyrexia; Vomiting	FLU3~EVANS VACCINES~765502~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1197M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211798	11/05/2003	NC	47.0	47		F	10/29/2003	Pt had flu shot and cholesterol finger stick. Went to massage chair and reportedly passed out while getting massage. Pt cool and clammy skin, face and lips pale. Checked BP and HR, client sweating and slow to respond. Gave 0.5ml sq epi 1:1000 to right arm. Pt reported feeling better. First responders arrived. Pt denied ER visit. 10/28/03 15:00 feels fine, no c/o. 17:22 BP 164/92 88-22. 17:27 122/76 80. 17:30 126/76 pt drinking soda, feeling better. 17:50 HR 104 after epi. 18:00 132/84 108 eating snack. 18:30 132/162 108 feeling better, spouse to pick up.									Y	10/28/2003	10/28/2003	0		OTH	PVT		NONE	UNK			1						1	Cold sweat; Hyperhidrosis; Loss of consciousness; Pallor	FLU3~EVANS VACCINES~765412~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211799	11/05/2003	PA	57.0	57		F	10/27/2003	Low grade temp. Diffuse muscle aches, swelling, headache, nausea, anxiety, elevated BP, bruise at injection site.				Y					U	10/24/2003	10/25/2003	1		PVT	PVT		NONE	Allergic to Keflex (rash)			1						1	Anxiety; Blood pressure increased; Contusion; Headache; Injection site oedema; Myalgia; Nausea; Pyrexia	FLU3~EVANS VACCINES~765180~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0604N~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211802	11/05/2003	FL	78.0	78		M	10/30/2003	Chills about 9 PM 10/28 to 4 AM 10/29. Upset stomach 9 PM 10/28 to 4 AM 10/29. Frequent urination, every hour 10 PM 10/28 to 4 AM 10/29. Rash appeared, upper body 4 AM 10/29. Slept most of 10/29 during day.									U	10/28/2003	10/28/2003	0		OTH	UNK	Diltiazem CD, aspirin	NONE	Emphysema			1						1	Chills; Pollakiuria; Rash; Somnolence; Stomach discomfort	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211804	11/05/2003	NC	64.0	64		F	10/31/2003	Awoken about 7 AM Oct 20 while working arms noticed small rash. That nite Oct 20 took hot shower. Next day Oct 21 rash had increased to stomach and each day it kept increasing. By Oct 26 rash covered arm, leg, stomach and on Oct 26 that night hives on arms and stomach about the size of a dime.				Y					Y	10/15/2003	10/20/2003	5		PUB	PVT	Insulin, Lasiz, Teporal, Metrpomittl		Cepholexin, Lotrinor			1						1	Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0211807	11/05/2003	NY	38.0	38		M	10/30/2003	Patient got the shot on Friday 10/24/03 and Saturday he had a fever 101 and sick to stomach and on Sunday he passed out on the toilet and stopped breathing for 3-5 minutes.									Y	10/24/2003	10/25/2003	1		PVT	UNK	Acephex; Tegretol; Gemfibrozil; Darvocet; Maalox	NONE	Left hemniplegia; Birth defect; Status post subdural hematoma.			1						1	Apnoea; Loss of consciousness; Pyrexia; Stomach discomfort	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211808	11/05/2003	GA	35.0	35		F	10/27/2003	Given pneumovax right arm 10/17/03. Reports 12 hours later developed severe pain, redness and whelps. Seen in our office 10/20/03, right deltoid swollen, red with nodules x3 about 2cm.				Y					Y	10/17/2003	10/18/2003	1	NONE	PVT	PVT	Paxil; Synthroid; Imitrex	Costochondritis	Fibromyalgia; Hyperlipidemia; Hypothyroidism; Migraines			1						1	Erythema; Pain; Skin nodule; Swelling; Urticaria	FLU3~EVANS VACCINES~765178~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0256N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211809	11/05/2003	FL	40.0	40		F		At 2:45 PM, noted left hand felt heavy and tingly. Felt short of breath, heart rate faster/pounding. Lasted 3 minutes and arm swelling at site; brown in color. Shortness of breath for about 16 hours. Took over the counter Benadryl - total 6 pills.									Y	10/16/2003	10/16/2003	0	NONE	PUB	OTH	Tegretol; Toprol	NONE	NONE			1						1	Dyspnoea; Heart rate increased; Injection site swelling; Palpitations; Paraesthesia; Sensation of heaviness; Skin discolouration	FLU3~SANOFI PASTEUR~U1081AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211810	11/05/2003	AR	33.0	33		F	10/24/2003	Local reaction at injection site, red, hot, tender, induration approximately 10cmx8cm. Given 10/22/03 at 15:00; started turning red at 18:30. Sunday AM 10/26, redness gone, induration remained with soreness. 10/29 09:00, redness induration, soreness resolved. Had some intermittent diarrhea.									Y	10/22/2003	10/22/2003	0	NONE	PVT	PVT	Home meds; Atenolol; Levilite BC; Parotonox; Spironolactolase; HCTZ	NONE	NKDA; No birth defects; HTN; Premature heart beat			1						1	Diarrhoea; Injection site erythema; Injection site induration; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U1075AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211812	11/05/2003	NY	2.0	2	.2	F	10/24/2003	Patient received 0.25cc of influenza vaccine on 10/21/03. Developed fever that night which increased to 104 degrees that next night.				Y					Y	10/21/2003	10/21/2003	0		PUB	UNK		URI	ISAD; Seizure disorder; Seasonal allergies			1						1	Pyrexia	FLU3~SANOFI PASTEUR~U1088AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211813	11/05/2003	CA	38.0			M	10/27/2003	Patient developed headache, myalgias, increased temperature, and fatigue 5 days after receiving influenza vaccine injection. See by physician 2 days after onset of symptoms and he will treat with acetaminophen and follow patient (Physician doubted that symptoms were due to influenza vaccine). No further information available.									U	10/16/2003	10/21/2003	5	NONE	PUB	UNK						1						1	Fatigue; Headache; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211814	11/05/2003	MA		51		F	10/28/2003	Onset diffuse papular rash 24 hours after flu vaccine (Evans # 765670) given.				Y					Y	10/22/2003	10/23/2003	1	NONE	OTH	UNK	Toprol; Estrogen	NONE	Allergy to sulfa, demoral, NSAIDS			1						1	Rash papular	FLU3~EVANS VACCINES~765670~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0211815	11/05/2003	MN		26		F	10/30/2003	Tachycardia, pale, sweating for 5 hours.				Y					Y	10/23/2003	10/23/2003	0	BP checked	PVT	PVT	Nortriptyline; Celexa; Cyclessa	NONE	NONE			1						1	Hyperhidrosis; Pallor; Tachycardia	FLU3~SANOFI PASTEUR~U1266AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211817	11/05/2003	MO	11.0	11		M	10/21/2003	Pustules on left shoulder and left leg. Ruptured pustules on left wrist. Developing rash on right shoulder.									Y	10/20/2003	10/20/2003	0	NONE	PUB	UNK		NONE				1						1	Blister; Rash pustular	FLU3~SANOFI PASTEUR~U1260AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211818	11/05/2003	OH	47.0	47		F	10/29/2003	Within two days, fever (low-grade), muscle aches, extremely sore throat, sinus congestion, fatigue, inability to work or function at home. Congestion, fatigue continue as of today (10/29/03).				Y					N	10/17/2003	10/18/2003	1		PUB	OTH	NONE	NONE	NONE			1						1	Fatigue; Myalgia; Nasal congestion; Pharyngolaryngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0211820	11/05/2003	DE	1.7	20		F	11/05/2003	Local reaction on right arm at site of vaccination.  Red, raised area.  On day of vaccination member ran a low grade temperature. No treatment was given.  Patient was evaluated by provider and was released.  Local reaction to flu vaccine.									Y	11/02/2003	11/03/2003	1		MIL	MIL	Birth Control Orthotrycycline Skeleton	None	None			1						1	Injection site erythema; Injection site reaction; Injection site swelling; Pyrexia	FLUX~UNKNOWN MANUFACTURER~765754~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211822	11/05/2003	NY	51.0	51		F	11/05/2003	diarrhea, severe vomiting every 15 minutes for 24 hours. neck pain, stiff neck and headache.									N	10/29/2003	10/31/2003	2		UNK	UNK	Allegra		penicillin			1						1	Diarrhoea; Headache; Musculoskeletal stiffness; Neck pain; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211858	11/05/2003	TN	70.0	70		F	11/05/2003	Patient complained of swelling, tenderness, and red stricks from injection site(RD)to arm pit.  Patient visited her primary care doctor on care whom felt that the shot had gone quickly to her lymph nodes.  Told pt to continue Benadryl and should resolve in a few days.				Y					Y	10/08/2003	10/09/2003	1		UNK	UNK		None	None Known			1						1	Injection site erythema; Injection site pain; Injection site swelling; Skin striae	FLU3~SANOFI PASTEUR~U1079AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0257N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211859	11/05/2003	KY	69.0	69		F	10/27/2003	Red, swollen, warm to touch, antiboitics.									Y	10/24/2003	10/24/2003	0	N/A	PUB	PUB		edema	Sulfa/HTN, Allergies, Asthma, COPD		KY2003095	1						1	Erythema; Injection site warmth; Swelling	FLU3~SANOFI PASTEUR~U1092AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~11119M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211860	11/05/2003	TN	69.0	69		F	11/05/2003	Patient complained of swelling, tenderness, and red streaks of/from injection site (LD).  Told patient to take Benadryl.  Spoke to Patient on 11/05/03 and she said she was feeling better.									Y	10/29/2003	10/31/2003	2		UNK	UNK						1						1	Injection site pain; Injection site swelling; Skin striae	FLU3~SANOFI PASTEUR~U1074AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0287N~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211861	11/05/2003	MD	43.0	43		F	11/05/2003	received injection to right deltoid oin 10/20/03; barely felt it go in, stung a little bit later, next day, her shoulder between the shoulder and the lateral neck surface felt painful, not the site of the injection and on 10/28/03 when she reported it to me, it still was tender at that area, not at the injection site. There was no redness there at all, never was, according to patient. She said she used Motrin but it didn't go away. I sent her to be evaluated. A doctor examined her and said he didn't know what relation there was of symptoms to the injection, but he coded it myositis right shoulder. He said it could have been that the needle hit a nerve, but pt told him that area never did hurt and when the injection was given, there was no pain there at all. A few minutes after injection she reported feeling the usual sting from a vaccine but did not report any sharp or immediate pain, tingling, numbness etc. She is able to move her arm and every day reports improvement. I spoke with her on 10/31/03, and by then she had a head cold, nasal stuffiness, no fever. She reported that her upper shoulder/neck area was improving.				Y					Y	10/20/2003	10/21/2003	1	none	UNK	PVT		none	anti-inflamatory meds			1						1	Myositis; Nasal congestion; Pain; Pharyngitis; Rhinitis; Tenderness	FLU3~SANOFI PASTEUR~U1139AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211863	11/05/2003	MA	57.0	57		F	11/05/2003	PT RECEIVED PCV23 AND INFLUENZA ON R ARM PER PT REQUEST SECONDARY TO LEFT ARM NERVE ISSUES AND PAIN.  24 AFTER ADM. PT CC: BODY ACHES, N/V, PAIN.  PT CAME TO HEALTH CENTER AND ASSESSED BY NP-FINDING INCLUDED ERYTHEMA, PAIN RADIATED TO NECK AS WELL.  AREA RED SWOLLEN (R DELTOID) PT UTILIZED ADVIL FEELING BETTER, +CMS.				Y					U	10/31/2003	11/01/2003	1		UNK	UNK						1						1	Erythema; Nausea; Pain; Vomiting	FLU3~EVANS VACCINES~765795~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0358M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211865	11/05/2003	IL	6.0	73		F	11/05/2003	Heat & pain in right arm during overnight hours on 10-31-03. Itching began approximately 1-2 days later. Treated at physicians office on 11-5-03 with Medrol dose pak & Atarax for itching.									Y	10/31/2003	10/31/2003	0		PUB	PVT	None noted	None reported by patient	None reported by patient			1						1	Feeling hot; Pain; Pruritus	FLU3~EVANS VACCINES~765712~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0564N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211866	11/05/2003	CA	49.0	49		F	11/05/2003	Swelling at site of vaccine and nausea, vomiting									Y	11/04/2003	11/04/2003	0		MIL	MIL	Previcid;Evista	None	asthma; eucalyptus; pollen			1						1	Injection site swelling; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~765753~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211828	11/06/2003	VA	9.0	8		F	11/04/2003	From initial information received on 10/31/03 from a health care professional regarding an adverse event occurring in the USA, it was reported that an 8 year old female patient received FLUZONE, lot number U1090AA, administered in the left thigh at 3:30 PM on 10/20/03. The next day, on 10/21/03, at 7:15 AM, the mother noticed that the patient, who was lying in bed, suddenly started shaking (upper torso), rolling her eyes and had a clicking noise from the mouth. The patient was taken to the ER immediately and she was hospitalized for one day. The patient recovered from these events. No other information was reported.  Follow up on 09/28/2004: Despite continued attempts to obtain follow-up, no further information was provided. No further information is anticipated, this case is considered closed.				Y	Y	1			Y	10/20/2003	10/21/2003	1	CT head, CBC, chem, U/A and EEG were done, however, no results were provided.	OTH	PVT		NONE	NONE		200302850	1						1	Eye movement disorder; Tremor	FLU3~SANOFI PASTEUR~U1090AA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0211829	11/06/2003	TN	82.0	81		M		This subject is a 82 year old male who died from a choking episode while enrolled in RSV 11 S & I study with RSV vaccine. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/31/2002. The subject died 353 days post immunization on 10/19/03. The subject choked on some food and 911 was called. Subject was taken to the hospital and pronounced dead on arrival. The subject's death was reported by the Investigator as unrelated to the study vaccine. A 15-day follow up report received 11/13/2003 adds: Additional info received on 11/3/03: Diagnosis: Cardiac arrest. According to discharge summary, pt was gasping for air more than choking. When intubated by the paramedics they did not see any food obstructing his airway. Resuscitation attempted in ER, but arrived there pulseless and remained pulseless. Family reported pt complained of intermittent chest pain over the past week. Etiology suspected arrythmia related. Cause of death: Cardiac arrest/pulseless electrical activity/idioventricular rhythm. Additional documents available with source file: ER note: 10/19/2003.	Y	10/19/2003							N	10/31/2002	10/19/2003	353		UNK	UNK	Imdur; Buspar; Mobic; ASA; Protonix; Pulmicort; Norvasc; Astelin; Atrovent; Advair; Cardura		Angina; Asthma; GERD; Anxiety; BPH; HTN: Arthritis		200302580	1						1	Cardiac arrest; Choking; Dyspnoea; Pulse absent	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0211831	11/06/2003	MI	75.0	75		F	10/30/2003	10/24/03 received vaccine around 10 AM. Had bad asthma attack at 12. At 3 Pm, became nauseous with pains in stomach; had numerous emesis and diarrhea. Lasted 24 hours.			Y						Y	10/24/2003	10/24/2003	0		PUB	UNK	Levaquin; Nebulizer; Xopenez; Ipratropium; Nitroglycerine; Verapamil; Ambien; Furosemide; Prevacid; Premarin; Baby aspirin; Inahler; Ormacort; Hypotears; Vitamin C; Multivitamin	Lung infection	Asthma; Emphysema; Hypertension; Hiatial hernia; Allergy to penicillin, Keflex, X-ray Dye, Thorazine medical record states colitis. msv			1						1	Abdominal pain upper; Asthma; Diarrhoea; Nausea; Vomiting	FLU3~EVANS VACCINES~765874~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening	Influenza
0211833	11/06/2003	WV	4.0	4		M	10/29/2003	10/15/03 Fever 101, arm sore. 10/16/03 Fever all day, arm sore/red. 10/19/03 Fever 104, arm red, sore and swollen.				Y					Y	10/15/2003	10/15/2003	0	NONE	PUB	PVT	Ritalin	NONE	Developmental delays/ADHD		WV0311	1						1	Erythema; Pain; Pyrexia; Swelling	FLU3~EVANS VACCINES~765146~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1027M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211834	11/06/2003	AZ	39.0	39		F	11/05/2003	Bright red, painful area at injection site upper arm (had received Pneumovax 10 years prior).									Y	10/29/2003	10/29/2003	0	NONE	PVT	PVT		NONE	NONE			1						1	Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U1093AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0564N~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211835	11/06/2003	LA	8.0	8		F	11/05/2003	Noticed redness and warmth 11/5/03 while at school in AM. Area 4cmx6cm approximately 1/2 below injection site. No welts, non-pruritic, afebrile.				Y					U	11/03/2003	11/05/2003	2	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Erythema; Feeling hot	FLU3~SANOFI PASTEUR~U1080AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211836	11/06/2003	VA	43.0	43		F	11/05/2003	Left arm parathesis.									U	11/05/2003	11/05/2003	0	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Paraesthesia	FLU3~EVANS VACCINES~765757~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211845	11/06/2003	VA	53.0	53		F	10/30/2003	12 hrs post vaccine developed itching and hives that worsened over the next 2 days-self medicated with Benadryl. Saw MD on day 3 and was put on Prednisone x 2 wks. Condition immediately improved with prednisone and has now resolved. Plans to see allergiest before future flu shots.				Y					Y	10/15/2003	10/16/2003	1		PUB	PUB	Sectral		Mitral valve prolapse; allergies-codeine, sulfa		VA03023	1						1	Pruritus; Urticaria	FLU3~EVANS VACCINES~765621~7+~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0211846	11/06/2003	NY	28.0	28		F	10/28/2003	10/23-arm swollen, large lump, sore, warm and red at site. Monday moving to armpit are sore and achy. Saw MD Tuesday 10/28 better. MD prescribed anti-inflammatory and took Advil. Md diagnosed as not adverse event just ?				Y					Y	10/22/2003	10/23/2003	1		PUB	PVT		NONE	Diabetic; PCN allergy			1						1	Injection site erythema; Injection site mass; Injection site oedema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U1269AA~5~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0740N~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211847	11/06/2003	KY	19.0	19		F	11/03/2003	Pt received flu vaccine 10/7/03. Reports developed itchy rash 3 days later. Did not report or seek medical attention due to child in hospital. Reports was told 10/30/03 by child's doctor to take Benadryl and use OTC cortisone cream. Presents to clinic today with red macular rash and multiple areas or ? on all limbs. Has not yet used meds.				Y					Y	10/07/2003	10/10/2003	3		PUB	UNK	NONE	NONE	NONE			1						1	Erythema; Pruritus; Rash macular	FLU3~SANOFI PASTEUR~U1099AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211848	11/06/2003	MA	66.0	66		F	11/01/2003	Severe diarrhea from 6am on 10/24/03 until 8am on 10/25/03.									Y	10/22/2003	10/24/2003	2	NONE	PUB	OTH	Fosamax, Premarin, Prilosec, Atenolol	NONE	NONE			1						1	Diarrhoea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211849	11/06/2003	MD	85.0	85		F	11/03/2003	Dizziness started 5:30pm 10/29/03 to 11pm 10/30/03 weakness started 5:30pom 10/29/03 to midnight 10/30/03. Irritability started 5:30pm 10/29/03 to midnight 10/30/03, nausea started 2:30pm 10/29/03 to midnight 10/30/03.									Y	10/29/2003	10/29/2003	0		PUB	PUB	HCTZ, Plavix, Benicar, Coreg, Synthroid, Zocor, Axid, Amoxicillin, Gaviscon, Tylenol 500mg		Hypertension, IBS, osteopenia, heart condition, sensitive to most antibiotics	Inflamed arm~Influenza (Seasonal) (no brand name)~~84.00~In Patient		1						1	Asthenia; Dizziness; Irritability; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211850	11/06/2003	WA	29.0	29		F	10/31/2003	Feet flushed, itchy chest, shaky, hives. Was treated with Solumedrol 125 mg IM, Benadryl 50mg IM. Discharged at 6:30pm feeling much better. She was seen and found to be having  an allergic reaction (hives, redness itching on anterior chest).									Y	10/28/2003	10/28/2003	0		PUB	PVT	Depo Provera, Diclox, Propranolol, Imitrex		Seizure disorder, depression, hx of methamd, migranes			1						1	Erythema; Hot flush; Hypersensitivity; Pruritus; Tremor; Urticaria	FLU3~EVANS VACCINES~765139~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211851	11/06/2003	WI	37.0	37		F	10/30/2003	Burning from shot site to elbow, tingling from elbow to fingers. Burning from injection site into neck area. Seems to be more painful with movement. Symptoms mild last evening, seem more pronounced today. Took 3 Advil this am-4:30am.									Y	10/29/2003	10/29/2003	0		OTH	PUB			NONE			1						1	Hypokinesia; Injection site inflammation; Pain; Paraesthesia	FLU3~EVANS VACCINES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211852	11/06/2003	TX	69.0	69		F	10/30/2003	Redness, swelling and heat on arm Pneumovax was administered. Redness and swelling lasted approximately 4 days. Treatment recommended oral Benadryl and ice packs on swollen area. Pt called Dr. was told allergic reaction-did not seek additional care.									Y	10/28/2003	10/28/2003	0		OTH	PVT		NONE				1						1	Erythema; Feeling hot; Hypersensitivity; Oedema peripheral	FLU3~SANOFI PASTEUR~U1253AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1027M~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211853	11/06/2003	IL	49.0	49		M	10/29/2003	Flu shot 4pm. By 3am I had chills, could not get warm, and was achy. Temperature of 100.4 within 24 hrs felt better.									Y	10/27/2003	10/28/2003	1		OTH	OTH		NONE				1						1	Chills; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1135FA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211867	11/06/2003	SC	75.0	75		F	11/06/2003	Rash on right arm around where injection given.  Some redness.  Treated with Benadryl and warm packs.  Instructed to see PMD if does not improve or becomes worse.									U	10/21/2003	10/22/2003	1	NONE	PUB	PUB		None	NONE		SC0343	1						1	Injection site erythema; Injection site rash	FLU3~SANOFI PASTEUR~U1145AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0445M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211868	11/06/2003	SC	54.0	54		F	11/06/2003	Elevated heart rate, some balance problems, sore throat.  General feeling of being weak.  Denied fever.  Difficulty walking on Sunday.  Ears blocked.  Symptoms relieved Sunday pm except for blocked ears.									Y	10/31/2003	11/01/2003	1		UNK	PUB	Lotril, ASA	Oral surgery on 10/28/03	Allergic to codeine		SC0344	1						1	Balance disorder; Difficulty in walking; Heart rate increased; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U1260AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211869	11/06/2003	MO	86.0	86		F	11/03/2003	5 pm 10-30-03 achy, fever, chills 10-31-03 symptoms continue - fever 102, heart racing.  11-01-03 & 11/02/03 remains in bed. Did not check temp. but feverish, chills continue.  11-03-03 temp to 99. feeling stronger.  Can eat.									Y	10/30/2003	10/30/2003	0		PUB	PUB	baby asprin				MO200392	1						1	Chills; Heart rate increased; Pain; Pyrexia	FLU3~EVANS VACCINES~765876~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211870	11/06/2003		50.0			F	11/06/2003	Patient describes a rash that tracked from the injection site to he whole back.  It presented 24 hours after injection.  No signs or irritation at the site of injection.  No fevers or other symptoms.  Rash was not hives and was decribed as a lacy type rash on back.  At time of evaluation --- 4 days later -- no rash				Y					Y	11/02/2003	11/03/2003	1	None	MIL	MIL	Plaquenil	None --- has history of SLE				1						1	Rash; Skin irritation	FLUX~UNKNOWN MANUFACTURER~765416 (PowerJe~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0211872	11/06/2003	GA	27.0	27		F	10/29/2003	Patient came in c/o right arm where flu vaccine was received.  Red whelp noted on right arm 21/4 inch x 3 inch . c/o no pain. but extreme itching.  Sent pt. to pmd. pt. called back and stated doctor said her arm was infected and put her on augmentin875mg bid. She is to f/u with him on Monday if not any better.  He stated she had adverse reaction to something in the vaccine				Y					Y	10/29/2003	10/29/2003	0		PUB	PUB	FASTIN QD	NO	NO			1						1	Injection site hypersensitivity; Injection site infection; Pruritus; Urticaria	FLU3~EVANS VACCINES~765415~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0211873	11/06/2003	MS	53.0	53		F	10/31/2003	Patient reports nose began swelling and turning red early AM 10/30/2003.  Small earaser size blisters appeared, present at time of complaint.  Patient denies any recent contact with plants, new products, animals.  Denies any pain, itching,  or problems on site.  Reports slight tickle on nose at blister site.  Patient given HC creme as well as the doctor instructed to use benedryl creme if needed.									Y	10/29/2003	10/30/2003	1	none	PUB	PUB	mvi and calcium supplement	none	none		MS03092	1						1	Blister; Erythema; Nasal oedema	FLU3~SANOFI PASTEUR~U1094AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211874	11/06/2003	MS	56.0	56		F	10/31/2003	Muscle spasms in right side of neck, weakness, nausea, lethargy.  Missed two days of work									Y	10/17/2003	10/19/2003	2	none	PUB	PUB	none	none	none		MS03093	1						1	Asthenia; Lethargy; Muscle spasms; Nausea	FLU3~SANOFI PASTEUR~U1094AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211875	11/06/2003	GA	56.0	56		F	11/06/2003	Felt uncomfortable in the evening after being given immunization injection. Had difficulty sleeping. Injection site is hot, red, swollen (area is approximately 11x3 cm.). Have felt generally uncomfortable. Never had a reaction to flu shot before this.									Y	11/04/2003	11/04/2003	0	None	PVT	UNK	Synthroid, Lotrel 5/20, Hctz, Aspirin.	NONE				1						1	Injection site erythema; Injection site swelling; Injection site warmth; Insomnia	FLU3~PFIZER\WYETH~~UNK~~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0211932	11/06/2003	CA	3.0	64		F	11/06/2003	Nausea, stomach pain, diarrhoea, weakness.									U	11/05/2003	11/06/2003	1		PUB	UNK	None	None	Allergy to wheat and tetanus vaccine			1						1	Abdominal pain upper; Asthenia; Diarrhoea; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211934	11/06/2003	WI	38.0	38		F	11/06/2003	11/03/2003. INFLUENZA VACCINE RECEIVED.  RASH DESCRIBED AS PEA SIZE, THEN BLOTCHY RED, ITCHY, HOT, PRICKLY.  STARTED ON WRISTS, PROCEEDED TO HANDS, TRUNK, LEGS, FEET.  11/06/2003.  THE RASH WAS NEARLY GONE.									Y	11/03/2003	11/05/2003	2		PUB	PVT	METABOLIFE EPHIDRA FREE	NONE	NONE			1						1	Erythema; Feeling hot; Rash; Rash macular	FLU3~SANOFI PASTEUR~U1099AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211936	11/06/2003	MN	4.0	3		F	11/06/2003	Patient given Immunaztion at 12:25pm.  father oc child's S/O picked child up at daycare.  Provider stated child seeemed tired starting around 3:00pm and remained that way all afternoon, S/O took tempature of child around 6:30pm when child felt warm, temp was 104F. S/O called nurse line on insurance card, Patient given Motrin per nurse instructions and told to watch for hives, and administer benadryl if hives seen.  Patient given bath around 7:30pm  3-4 hives noticed on trunk and face, benadryl given.  Patient had no appetite in the evening.  Patient awoke around 10:45pm, with a fever 104.5F and all over body redness.  Given another dose mortin and benadryl, and taken to ER by father.				Y					U	11/05/2003	11/05/2003	0	Unknown	PVT	PVT	none	No fever, in the past 24 to 48 hours per patients father.	Periodic Fever Syndrome			1						1	Anorexia; Erythema; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U1125AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211938	11/06/2003	FL	38.0	38		F	11/06/2003	RECEIVED FLU SHOT 11/2/03 AROUND 1430. AFTER AROUND AN HOUR C/O FEELING STUFFY HEAD, DIZZY, SHAKEY FEELING,AND BODY WEAKNESS.BENEDRYL 25MG PO. DOCTOR ORDERED 24MG MEDROL PO GIVEN @ 1634. WENT TO ER @ 1640. 1900 IV NS 1000CC BOLUS, BENEDRYL 25MG IVP, ZANTAC 50MG IVP. 1915 ORTHOSTATIC BPS 139/94 HR 92 LYING, BP 144/90 HR 84 SITTING, STANDING 112/65 HR 96. 1915 C/O CHEST TIGHTNESS EKG DONE. ADMITTED 23HOUR OBSERVATION @ 2248. D/C'D FROM HOSPITAL 11/3/03 @ 1230. The medical records received on 1/12/04 states achey, body pain, headache and SOB.				Y	Y	1			Y	11/02/2003	11/02/2003	0	Lab test abnorm.	UNK	PVT	ZOLOFT,	NO	NO			1						1	Asthenia; Blood pressure increased; Chest discomfort; Dizziness; Dyspnoea; Headache; Laboratory test abnormal; Nasal congestion; Pain; Tremor	FLU3~EVANS VACCINES~765875~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0211939	11/06/2003	TN	46.0	46		F	11/06/2003	Patient had some swelling in the arm around where the shot was given.  It was hot to the touch.  She complained it was painful to move.  The redness and irritation started about 24 hours after vaccination.  She was advised to take Benadryl by mouth.									N	11/04/2003	11/05/2003	1	negative	UNK	PVT	unknown	None	Unknown			1						1	Erythema; Injection site warmth; Pain; Skin irritation; Swelling	FLU3~SANOFI PASTEUR~U1254AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0257N~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211940	11/06/2003	IL	67.0	66		F	11/06/2003	11/04/03- Throbbing pain L upper arm- pain continues. 11/06/03 Devoloped red flat warm area approximately 2.5 long and 0.5 wide approximately 7 away from vaccine injection site									U	11/04/2003	11/04/2003	0	None	PUB	PUB	Celebrex, Hydrochlorothiazide, Timoptic eye drops	NO	Arthritic			1						1	Erythema; Injection site warmth; Pain	FLU3~EVANS VACCINES~766050~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0947N~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211941	11/06/2003	NJ	74.0	74		M	11/06/2003	Within 1-2 hours of receiving flu shot, I started to get aches, irritation and stiffness in the first and second joints of first and middle fingers of my left hand (shot in left arm).  After several days, same in middle finger of right hand. This has lasted 10 days to date. This is my first flu shot and my fingers definitely do not feel the same as they were before the shot.  I am convinced these strange symptoms were due to the shot and would like to know whether they will disappear in time.									Y	10/28/2003	10/28/2003	0		UNK	UNK	monopril		high blood pressure			1						1	Joint stiffness; Pain; Skin irritation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211878	11/07/2003	OH	48.0	48		F	11/04/2003	From initial information received on 11/3/03 from a health care professional, regarding an adverse event occurring in the USA, it was reported that a 48 year old female patient received FLUZONE, lot number U1271AA, administered IM in the left deltoid on 10/31/03 at 7:50 AM. Immediately following administration of the product, the patient complained of feeling faint. Approximately one minute after sitting her down, she went into anaphylaxis and had a loss of pulse and breathing. She was pale, cool and clammy. Epinephrine .2 cc was administered SC and the patient responded in approximately 30 seconds. The patient was transported to the hospital and was seen in the ER. The patient reportedly did recover from this event. (OMIC)  Follow up on 01/09/04: From additional information received on 12/29/03 from mail correspondence received from the initial reporter, the ER physician and telephone number where the pt was treated was provided.  It was also reported that the ER records were not available and that this pt had no previous influenza immunizations.  The adverse reaction lasted approximately three minutes.  The reporter states that this pt initially stated there were no known allergies, but in a recent conversation stated she had an allergy to sulfa drugs.  No allergy testing was performed.  The reporter stated, Reviewed, no additional information at this time.  No additional information is expected, therefore, this case is considered closed. 60-day follow up on 02/11/04: Pt has recovered from adverse event. Per conversation, she has been monitored (by her family doctor) for a possible irregular heartbeat-the results being inconclusive.				Y					Y	10/31/2003	10/31/2003	0		OTH	OTH	Synthroid	NONE	The patient has a history of hypothyroidism, for which she takes Synthroid. Prior to receiving the influenza vaccine on 10/31/03, the patient denied any allergies.		200302865	1						1	Anaphylactic reaction; Apnoea; Cold sweat; Dizziness; Pallor; Pulse absent; Anaphylactic shock; Apnoea; Cold sweat; Pallor; Pulse absent; Urinary incontinence	FLU3~SANOFI PASTEUR~U1271AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1271AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0211884	11/07/2003	FL	76.0	76		M	11/04/2003	Became ill with acute bronchitis shortly after receiving injection. Did not respond to treatment as quickly as he usually does.  60-day follow up on 01/28/04: Pt has recovered from adverse events. Nurse follow up on 05/18/04: shortness of breath, wheezing, pneumonia, chest pain, cough, anxiety, fatigue.			Y						N	10/02/2003	10/07/2003	5	Culture positive Pseudomonas; Increased WBC	PVT	PVT		COPD; CAD	COPD; CAD; HTN; CHF			1						1	Anxiety; Bronchitis acute; Chest pain; Condition aggravated; Cough; Dyspnoea; Fatigue; Laboratory test abnormal; Pneumonia; Wheezing; White blood cell count increased	FLU3~EVANS VACCINES~765669~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening	Influenza
0211885	11/07/2003	WI	46.0	46		M	11/06/2003	Diarrhea and upset stomach (mentioned first).  Feverish feeling; fever not verified; patient didn't have thermometer.  Fatigue.  Time course that evening, next day.  Recommended APAP (OTC) and fluids.  (Diarrhea is not a side effect of vaccine).									Y	11/05/2003	11/05/2003	0	NONE	OTH	PVT	APAP (OTC)	NONE	NONE			1						1	Diarrhoea; Fatigue; Pyrexia; Stomach discomfort	FLU3~EVANS VACCINES~765798~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211886	11/07/2003	MN	22.0	22		F	11/06/2003	Panic attack like symptoms.  Tightness in chest.  Wheezing, dizziness, nausea.				Y					Y	11/05/2003	11/05/2003	0	NONE	PUB	PVT	Maxiair, Flovent	NONE	Prednisone, Dime tepp allergy			1						1	Chest discomfort; Dizziness; Nausea; Panic reaction; Wheezing	FLU3~EVANS VACCINES~765878~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0211887	11/07/2003	WV	49.0	48		F	10/31/2003	Patient received flu clinic at am off-site clinic at school on 10/24/2003 afternoon Sat.  Noted welt and redness.  Later saturday evening-noted more redness around site.  No fever or other steady state noted.  Went to ER.  Instructed to take Benadryl, ice and ret if worsen.  Patient recovered completely.  No other complaints.									N	10/24/2003	10/25/2003	1	NONE	OTH	PUB	NONE	NONE	NONE		WV0313	1						1	Erythema; Urticaria	FLU3~SANOFI PASTEUR~U1271AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211888	11/07/2003	WV	55.0	55		F	10/29/2003	Received flu vaccine yesterday 10/28/2003.  Patient had a little stomach ache before cause for vaccination.  None since receiving.  Has noticed slight headache, some chilling.  Local redness and warmth noted at site (left deltoid) and slight tenderness today.  Referred to MD (family) per follow up.  To report back to health department.									N	10/28/2003	10/29/2003	1	NONE	OTH	PUB	NONE	Slight nausea, getting over a cold	Bowel problems, urinary tract infection, arthritis		WV0314	1						1	Feeling cold; Feeling hot; Headache; Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U1260AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211889	11/07/2003	NC	40.0	40		F	11/06/2003	Approximately 10 minutes after receiving vaccine, patient reports feeling very hot-this started gradually and escalated to the point where I felt like I was on fire.  She soon developed weakness of her lower extremities (within 20 minutes), making standing difficult.  She reported trouble with her thought processes and verbalization.  Within 30-40 minutes, she became somnolent; difficult to engage in any conversation, but answered simple questions appropriately.  She was taken to the ER at that time.				Y					Y	10/23/2003	10/23/2003	0	Glucose: 198; Calcium: 7.8;	PUB	PVT	Insulin Humalog/ Lantis	Diabetes	Diabetes, Allergic to shellfish	Stiffness/joint~Pneumo (no brand name)~1~39.00~In Patient		1						1	Asthenia; Hot flush; Somnolence	FLU3~SANOFI PASTEUR~U1132AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211890	11/07/2003	NC	38.0	38		F	11/06/2003	Patient states that almost instantaneously she began feeling something strange in her cheeks and below her eyes.  She could not move her facial muscles as usual.  She then felt a pressure-like feeling at top of her neck and her left arm became weak and insensitive to touch.  States both legs were jelly-like and wobbly.  She denied any shortness of breath, diaphoresis at that time.  She was taken to the ER at that time.  Vital signs were stable (slightly tachycardic).				Y					Y	10/17/2003	10/17/2003	0	NONE	PUB	PVT	NONE (Vitamins)	NONE	Endocrine disorder, Low blood sugar			1						1	Muscular weakness; Sensation of pressure; Tachycardia	FLU3~EVANS VACCINES~765795~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0211892	11/07/2003	GA	77.0	77		F		Patient began feeling chills, achy and pain under ribs shortly after returning home from receiving influenza vaccine.  Patient also began to feel chest tightness next day and went to hospital next morning (10/18/2003).  Patient reports feeling much better but still feels chest tightness (10/28/2003).					Y	1			U	10/17/2003	10/17/2003	0	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Chest discomfort; Chills; Pain	FLU3~EVANS VACCINES~765496~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0211893	11/07/2003	AR	64.0	64		M	11/03/2003	Headache, dizziness, fever, chills, body aches.				Y					Y	11/03/2003	11/03/2003	0	CBC	PVT	PVT	Lopressor, Prevacid	NONE	Hypertension, Dyspepsia, Retroperitoneal hemorrhage			1						1	Chills; Dizziness; Headache; Pain; Pyrexia	FLU3~EVANS VACCINES~765273~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0211894	11/07/2003	NY	89.0	89		F	10/29/2003	Patient lost consciousness became diaphorec.  Blood pressure 90/60.  Pulse 60.  Patient diabetic as per niece. Paramedics called blood sugar. 247 patient transported to ER.				Y					U	10/29/2003	10/29/2003	0	Blood sugar 247	PUB	PUB	NONE	NONE	Diabetic			1						1	Blood glucose increased; Blood pressure decreased; Heart rate decreased; Hyperhidrosis; Loss of consciousness	FLU3~SANOFI PASTEUR~U1126AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211896	11/07/2003	NY	23.0	23		F	10/31/2003	Employer received flu vaccine left arm 10/30/2003 in AM. Complained of pain in right arm in afternoon and went to the ER.  No redness or swelling noted.  MD believes it is neuropathy of brachiol pleause.  To go to neurologist.									N	10/30/2003	10/30/2003	0	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Pain	FLU3~EVANS VACCINES~765855~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211897	11/07/2003	WA	70.0	73		F	11/01/2003	3-4 minutes after immunization.  Tingling arms, back and lightheadedness so patient was reclined.  Then complained of worsening arm, neck, back and chest pain.  Continued to worsen over 5 minute period.  Ambulance called.  Crew reported hypertensive both laying down and sitting and high blood glucose.  Patient transported by family to ER for follow up.				Y					Y	10/29/2003	10/29/2003	0	NONE	OTH	PVT	NONE	NONE	Diabetes			1						1	Blood glucose increased; Dizziness; Paraesthesia	FLU3~SANOFI PASTEUR~U1256AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1079M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211898	11/07/2003	FL	65.0	65		F	11/01/2003	Gave flu and pneumo shot in same left arm.  Arm was sore that night.  Started to feel achy that night.  Had fever and chills next day.  Arm couldn't move.  Red and swollen arm.  Took Aspirin.  Large 4 inches.									Y	10/29/2003	10/29/2003	0	NONE	OTH	OTH	NONE	NONE	Very allergic person			1						1	Erythema; Hypokinesia; Injection site pain; Oedema; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1079AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0944N~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211899	11/07/2003	IL	70.0	70		M	11/01/2003	Badly swollen right arm near shoulder - very painful between shoulder and elbow on muscle at rear of arm.  Nurse gave shot on back of arm in this muscle-shot was painful, fever of 101.  Also ached over entire body.  Call doctor, he started to take Tylenol.  Stay in bed and drink warm chicken soup, which I did.  It took almost three days for the swelling to go down though I only stayed in bed one day.									Y	10/23/2003	10/23/2003	0	NONE	PUB	OTH	NONE	NONE	NONE			1						1	Injection site oedema; Injection site pain; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0211900	11/07/2003	TX		76		F		Fever and chills same day after vaccine given.  Also localized reaction in the right deltoid/arm.  Red/tender/warm down arm.  Localized inflammation.									U	09/30/2003	09/30/2003	0	NONE	PVT	OTH	NONE	NONE	PCN, SULFA			1						1	Feeling hot; Injection site erythema; Injection site inflammation; Injection site pain; Pyrexia	FLU3~EVANS VACCINES~765497~3~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0068N~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211901	11/07/2003	WI	75.0	75		F	11/01/2003	Approximately 2 hours after shot, I began to feel dizzy and kinda weak.  Sat down.  Finally laid down to see if dizziness would car up (missed class).  Approximately 7 hours later the dizziness was clearing and returned to normal shortly thereafter.									Y	10/28/2003	10/28/2003	0	NONE	OTH	OTH	General health meds including thyroid etc.	NONE	NONE			1						1	Asthenia; Dizziness	FLU3~SANOFI PASTEUR~U1075AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211902	11/07/2003	WI	75.0	75		F	10/31/2003	Adverse reaction was only to pneumococcal vaccine.  Swelling was excessive and covered approximately a 4 inch length in muscle area above elbow.  Redness was excessive and covered the entire swollen area.  There was itching, soreness and pain in this area.  It took approximately 5 days before all symptoms cleared up.  I used hydrocortisone and Wal-iton recommended by pharmacist.  I had one pneumonia shot 5 years prior to this one with no reaction.  Follow up on 11/25/03: I had no problem with the Influenza vaccine.									Y	10/18/2003	10/18/2003	0	NONE	PUB	OTH	Ibuprofen; Cozaar	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site pain; Pruritus	FLU3~SANOFI PASTEUR~411141HH~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0675M~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211903	11/07/2003	VA	3.0	3		M	11/03/2003	Father reports that the evening that patient received the vaccine he complained of pain at injection site.  Thigh became edematous and red from the left groin to left knee.  Patient sought medical treatment on 11/03/2003.				Y					U	10/31/2003	10/31/2003	0	NONE	PVT	PVT	NONE	NONE	Small ventricular septal defect			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U1145AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211904	11/07/2003	NY	53.0	52		M	10/30/2003	Upon waking on 10/23/2003, he complained of right sided chest pain on deep breath, pain in back of throat, feeling flushed and fatigued.  Has history of spinal compression.  Complains of feeling increased spastic and unsteady on feet.  Symptoms resolved 10/26/2003.				Y					Y	10/21/2003	10/23/2003	2	NONE	PVT	OTH	Colace; Trileptal; Diaziac; Pravacol	NONE	PCN ALLERGY			1						1	Chest pain; Fatigue; Flushing; Gait disturbance; Throat tightness	FLU3~SANOFI PASTEUR~U1147AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211905	11/07/2003	OH	61.0	61		M	11/02/2003	Shot taken on Wednesday (Oct 15). 4 days later started having congestion, coughing and sore throat. Very aching body. Loss of appetite. Lung area very tender and painful. (Temperature).									N	10/15/2003	10/19/2003	4		OTH	OTH		NONE		~Influenza (Seasonal) (no brand name)~~51.00~In Patient		1						1	Anorexia; Cough; Nasal congestion; Pain; Pharyngolaryngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211906	11/07/2003	OH	60.0	60		F	11/02/2003	Shot taken on Wednesday (Oct 15). 4 days later started having congestion, coughing and sore throat. Very aching body. Loss of appetite. Lung area very tender and painful. One round (10 days) of Tequin tablets 400 mg. Need another. (Temperature).									N	10/15/2003	10/19/2003	4		OTH	OTH		NONE		~Influenza (Seasonal) (no brand name)~~50.00~In Patient		1						1	Anorexia; Cough; Nasal congestion; Pain; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U1138AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211907	11/07/2003	WV	55.0	55		F	10/03/2003	Right side body numbness, 5 episodes to date, recover in 10 minutes from each episode. Flu and pneumonia shots received on 10/22/2003. First episode 10/25/03. Numbness starts in face and works down the body, right side only.				Y					U	10/22/2003	10/25/2003	3	Carotid artery test, EKG, echocardiogram, blood work	PUB	OTH	NONE	NONE	NONE			1						1	Hypoaesthesia	FLU3~SANOFI PASTEUR~U1145AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0819M~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0211908	11/07/2003	IL	25.0	25		F	11/02/2003	Severe chest pain, extreme dizziness.				Y					Y	10/23/2003	10/23/2003	0	EKG	PVT	UNK	NONE		Allergic to penicillin			1						1	Chest pain; Dizziness	FLU3~EVANS VACCINES~765707~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0211924	11/07/2003	CA	4.0	4		F	10/30/2003	Within 2 minutes of injections, pt said she wanted to go home. Lay down on ground in exam room; mom lifted her up, noted blue-tinged lips. MD assessment at about 5 minutes: unresponsive, eyes closed, heart rate 40-48, clear breath sounds, pulse ox 100%. Given O2 and SQ epinephrine - HR to 70-80, opened eyes, still lethargic, more responsive, verbal response at 15-20 minutes. Full recovery at about 1 hour, after transport to ER.				Y					Y	10/30/2003	10/30/2003	0		PVT	PVT	NONE	NONE	NONE			1						1	Coma; Cyanosis; Lethargy	DTAP~SANOFI PASTEUR~C1527AA~5~~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1139AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0619N~1~~LA~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~Y0148~4~~LA~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0274N~2~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0211929	11/07/2003	UT	5.0	5		F	11/06/2003	Swollen, red, hot, bruised.									U	11/04/2003	11/05/2003	1		PVT	PVT	NONE	NONE	NONE			1						1	Contusion; Injection site erythema; Injection site oedema; Injection site warmth	DTAP~SANOFI PASTEUR~U1027CA~5~IM~~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1133AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~079M~2~IM~~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~W1156~4~IM~~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~1229M~2~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0211942	11/07/2003	TX	64.0	64		F	11/07/2003	Broke out in hives on legs,feet and hips 6 days after vaccination.  Treated the rash with Lidex Cream 0.05% that my dermatologist had prescribed previously.  The hives lasted 2 days.									Y	10/29/2003	11/04/2003	6		PUB	PUB	I had taken a 35mg Actonel tablet several hours earlier and had applied Carac fluorouracil cream 0.5% topical to a spot on my nose for the previous 6 days	none	Many years ago I was tested as mildly allergic to eggs, but was not allergic when tested in 1999.  However, I did show a mild allergy to chicken in 1999.  For years I have had a rash of small bumps on my abdomen, but it is completely different from the hives I experienced this week.			1						1	Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211943	11/07/2003	VA	19.0	0	.0	F	11/07/2003	PATIENT COMPLAINED OF NAUSEA AND VOMITTING, ALSO SWELLING AND ITCHING AT THE SITE OF INJECTION. ON EXAM THERE WAS A 5CM INDURATION ON THE DELTOID OF LEFT ARM. PATIENT WAS TREATED WITH DIPHENHYDRAMINE 25MG				Y					Y	11/04/2003	11/06/2003	2	NONE	MIL	MIL	ALLEGRA, SINGULAIR	SEASONAL ALLERGIC RHINITIS	SEASONAL ALLERGIC RHINITIS			1						1	Injection site hypersensitivity; Injection site swelling; Nausea; Pruritus; Vomiting	FLU3~SANOFI PASTEUR~UNKNOWN~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~UNKNOWN~2~IM~RA~HEP A + HEP B (TWINRIX)~1	USA	Emergency room visit	Influenza
0211947	11/07/2003	MI	47.0	47		F	11/07/2003	Within 2 hours patient experienced moderate headache, with visual disturbances specifically depth perception problems and weakness.  Left arm also extremely sore. Patients vitals taken and stable but placed in bed and allowed to rest and then sent home.									Y	11/03/2003	11/03/2003	0	none	PUB	PVT	none	none	none			1						1	Asthenia; Headache; Visual disturbance	FLU3~SANOFI PASTEUR~U1124AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211948	11/07/2003	VA	32.0	32		M	11/07/2003	Patient received Anthrax #5 and influenza on 3 June 2003.  The evening following vaccination, aproximately 6-8 hours, he developed multiple papule/urticaria lesions on the lower extremities that progressed to the lower back,abdomen,arms and shoulders. The rash non-erythematous and pruritic lasting 15 minutes.  The rash reoccurred one week later around the same time in the evening.  He was treated with benadryl and zyrtec.  Symptoms resolved.  Two weeks later, he was deployed.  During his deployment, he experienced 3 more episodes of urticaria.  The third episode consisted of facial swelling of the lips, eye lids and testicular area lasting several hours.   Since his return from deployment in August, he has not had any further outbreaks.				Y					Y	07/03/2003	07/03/2003	0	Referred to Allergy/Immunology for skin testing	MIL	MIL		None	None			1						1	Eyelid oedema; Face oedema; Rash; Scrotal oedema; Skin ulcer; Swelling face; Urticaria	ANTH~EMERGENT BIOSOLUTIONS~Unknown~5~SC~UN~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~Unknown~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0211949	11/07/2003	MN	73.0	73		F	11/07/2003	Shot give at 11:30 Am at 7:30 PM arm swollen and red tightening in throat and got funny  Went to ED and received benadryl and epi				Y					Y	11/06/2003	11/06/2003	0		UNK	PVT			Allergies PCn and Erythromycin			1						1	Erythema; Pharyngeal oedema; Throat tightness	FLU3~EVANS VACCINES~765485~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0211950	11/07/2003	OH	39.0	38		F	11/07/2003	DEVELOPED REDNESS, SWELLING, & ITCHING AT VACCINATION SITE APPROXIMATELY 12 HOURS AFTER RECEIVING FLU SHOT.  SHE TOOK DIPHENHYDRAMINE  EVERY 4-6 HOURS FOR 24 HOURS BUT BY NEXT DAY (10/22 AM) REPORTED HIVES OVER ENTIRE LEFT ARM AND ACROSS CHEST AND LOWER LIP SWOLLEN.  WAS TREATED AT CLINIC WITH ATARAX AND STEROID INJECTION AND PRESCRIBED ZYRTEC FOR 7 DAYS.				Y					Y	10/20/2003	10/21/2003	1	NONE	PVT	PVT		NONE	ALLERGIES: BACTRIM, CODIENE, DARVOCET,& MORPHINE			1						1	Face oedema; Injection site erythema; Injection site hypersensitivity; Injection site swelling; Pruritus; Urticaria	FLU3~EVANS VACCINES~765704~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212017	11/07/2003	OR	32.0	32		F	11/07/2003	Classic flu-like symptoms - headache, body ache, sore throat, dry cough, low grade fever, fatigue									Y	11/05/2003	11/06/2003	1		PUB	UNK		none		flu-like symptoms~Influenza (Seasonal) (Flu-Imune)~~28.00~In Patient		1						1	Cough; Fatigue; Headache; Influenza like illness; Pain; Pharyngolaryngeal pain; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|HEP~UNKNOWN MANUFACTURER~~2~~~HEP B (NO BRAND NAME)~1	USA		Influenza
0212021	11/07/2003	TX	3.0	3		M	11/07/2003	Received vaccine at approx 1430 on 11/6/03.  Hives noticed at 0800 11/7/03. Greatest concentration noted on extremity where vaccine administerd				Y					Y	11/06/2003	11/07/2003	1		MIL	MIL		upper respiratory	asthma, eczema			1						1	Urticaria	FLU3~SANOFI PASTEUR~~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212023	11/07/2003	NY	73.0	73		F	11/07/2003	Pneumovax administered in right arm on 11/5 in the morning.  By that evening, patient's right arm from her shoulder and one half way to her elbow was swollen.  She felt so much pain there that she couldn't lift her arm.  She had a fever of 102 degrees. On 11/6, her fever was 101.8 degrees.  Her arm still hurt, but less.  She spent the day in bed. Today, 11/7, she is still recovering, but feels a little better.  Though her arm is still tender, it is functional.  She is afebrile today.									Y	11/05/2003	11/05/2003	0		PUB	PUB						1						1	Joint range of motion decreased; Oedema peripheral; Pyrexia	FLU3~EVANS VACCINES~765851~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0988N~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212024	11/07/2003	NC	57.0	56		F	11/07/2003	rash, malaise, syncope; The follow up received on 11/12/03 states onset of rash same day; treated in office 11/5/03 with Zantac/Solucottep. 11/4/03 returned to office with syncopy, hypotensive-to hospital ICU-remains in hospital 11/11/03.			Y	Y	Y				Y	11/04/2003	11/04/2003	0	Lab test abnormal.	UNK	UNK			Hypertension			1						1	Hypotension; Laboratory test abnormal; Malaise; Rash; Syncope	FLU3~EVANS VACCINES~765668~7+~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0212028	11/08/2003	TX	61.0	61		U	11/08/2003	First day after shot..... had a slight headache, arm ached where shot was given,sore throat and fever of 99.6.  Second day after shot.... had a bad headache, whole body ached, worse sore throat, chills all day and fever of 100.1.  Then last night.... I was up all night with chills and such a sore throat that I could not swallow. I have a headache, my whole body aches, my nose is burning and running hot water. My ears are hurting and itching terribly. My are where I got the shot is so sore that I can bearly lift it.									U	11/05/2003	11/06/2003	1		UNK	UNK	celebrax premarin nexium		lots of food intolerances, but not to eggs to my knowledge			1						1	Chills; Dysphagia; Ear pain; Headache; Joint range of motion decreased; Pain; Pharyngolaryngeal pain; Pruritus; Pyrexia; Blister; Chills; Cough; Headache; Pharyngolaryngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0212029	11/08/2003	VA	47.0	47		M	11/08/2003	Erythma Multiforma (oval bulls-eye rashes around midsection and under arms) - potential immune response to Flu Shot				Y					Y	10/22/2003	10/24/2003	2		UNK	PVT	None	None	Amoxycillin			1						1	Erythema multiforme	FLU3~SANOFI PASTEUR~U1127AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212030	11/09/2003	MI	4.0	4		F	11/09/2003	Redness and swelling of arm where vaccine was administered with area of redness measuring 12X8 cm.				Y					U	11/07/2003	11/08/2003	1		PVT	PVT	none	none	none			1						1	Erythema; Swelling	FLU3~EVANS VACCINES~765799~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212031	11/09/2003	GA	46.0	46		F	11/09/2003	Muscle aches, fever spikes, loss of appetite, lethargy				Y					Y	11/07/2003	11/07/2003	0		UNK	PVT		None	Allergies to Cat and Dust mites			1						1	Anorexia; Lethargy; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0212033	11/09/2003	PA	19.0	0	.2	F	11/09/2003	about two days after the vaccine, patient began to experience dizziness and headaches.  after several days of worsening, she went to the infirmary.  she received medication for motion sickness, which seemed to relieve the dizzines, to some degree.  after two days the medication was used up, but the symptons persisted.  she went to the hospital and received the same anti motion sickness medication.  it has been about 10 days since she had the vaccine, and the problems still persist.				Y					N	10/28/2003	10/30/2003	2	don't know	UNK	UNK		none	TMJ			1						1	Dizziness; Headache	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0212034	11/09/2003	DC	47.0	46		M	11/09/2003	Patient is a health 47 year old male physician.  Annual attenuated virus flu vaccination received for the past five years without any sequelae. 36 hours post flu-mist innoculation, Patient developed persistent, extremely bothersome rhinitis and fatigue.  No fever, myalgia, or other symptoms.									U	11/07/2003	11/09/2003	2		UNK	UNK		none	none			1						1	Fatigue; Rhinitis	FLUN3~MEDIMMUNE VACCINES, INC.~500013P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|PPV~MERCK & CO. INC.~~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211958	11/10/2003	MN	50.0	50		F	10/21/2003	Cellulitis left upper arm.					Y				Y	10/16/2003	10/17/2003	1		PVT	UNK	HCTZ, Wellbutrin, Metopicolol, Lisinopril	Anxiety/Depression	Penicillin, sulfur, HTN,			1						1	Cellulitis	FLU3~SANOFI PASTEUR~U1126AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~490909~1~~LA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0211959	11/10/2003	CT	51.0	51		F	11/03/2003	4:30 PM started itching. Approximately 8 PM, hives noted on back, arms and chest. In AM, hives over entire body so called MD; went to ER. Received IV medication, O2, and Breathing prescription. Sent home on anti-puritic and cortisone. Nurse follow up on 06/08/04 states: Bronchspasm, wheeze, rash.			Y	Y					Y	10/28/2003	10/28/2003	0	UNK	OTH	PUB		NONE	Asthma	Not sure~Vaccine not specified (no brand name)~~42.00~In Patient		1						1	Bronchospasm; Pruritus; Rash; Urticaria; Wheezing	FLU3~EVANS VACCINES~765146~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening	Influenza
0211963	11/10/2003	MD	45.0	45		M	11/07/2003	On 10/31/03 received flu vaccine; around 6 PM on 10/31/03 felt pain in left arm/hand; pt took Advil and had difficulty sleeping due to pain; no redness; arm was normal color and temperature; on 11/3 and 11/4 felt less pain; on 11/5 at gym when lifting 40 lb weight felt sharp pain, worse than on 10/31/03. Continues to have pain when lifting and moving arm; no fever.									N	10/31/2003	10/31/2003	0		UNK	OTH	Wellbutrin		Depression			1						1	Insomnia; Pain	FLU3~SANOFI PASTEUR~U1089AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211964	11/10/2003	MN	60.0	60		F	11/07/2003	Chest pains, headache, fever, bones ached.									Y	11/04/2003	11/04/2003	0		OTH	PVT	NONE	NONE	NONE			1						1	Chest pain; Headache; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211968	11/10/2003	CA	61.0			M	11/07/2003	Week post flu vaccination the patient developed bilateral lower extremity weakness. Nerve conduction study was compatible with the diagnosis of GBS> Bilateral weakness was present with absence of deep tendon reflexes. Patient was admitted to ICU; given 5 doses of IVIG and transferred to rehab.					Y	7			Y	10/20/2003	10/28/2003	8	MRI: no abnormal findings; Nerve conduction test consistent with GBS; Lumbar puncture negative	PVT	PVT		NONE	NONE			1						1	Areflexia; Guillain-Barre syndrome; Immunoglobulin therapy; Intensive care; Lumbar puncture abnormal; Muscular weakness; Nerve conduction studies abnormal; Nuclear magnetic resonance imaging normal; Back pain; Guillain-Barre syndrome; Hypertension; Hyporeflexia; Laboratory test abnormal; Muscular weakness; Oedema peripheral; Urinary tract infection	FLU3~SANOFI PASTEUR~U1078AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1078AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0211969	11/10/2003	AK	37.0	37		M	10/29/2003	c/o body aching with hot and cold feelings since yesterday evening and nasal drainage and diarrhea. Left arm and shoulder tender and painful. Small reddened area, size of quarter, over left arm injection site. No swollen nodes at neck/axilla area.									U	10/27/2003	10/28/2003	1	Tympanic temperature 97.4	PUB	UNK	Immodium, Thermo Flu drink		Denied known allergies at administration		AK200338	1						1	Diarrhoea; Feeling cold; Injection site erythema; Pain; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1141AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~719B6~2~IM~LA~HEP A (HAVRIX)~1|PPV~MERCK & CO. INC.~1212M~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211970	11/10/2003	AK	67.0	67		M	10/16/2003	Telephone from the client, reporting an episode of feeling dizzy, falling and losing consciousness this AM. He reported that it took him a few minutes to clear his head, but feels fine now. Contacted PHN 20 minutes after it occurred. Episode occurred after his morning walk. He reports eating breakfast before the walk. He denies that anything like this has ever occurred before. He wanted to know if it was related to the Flu and Td immunization that he received yesterday 10/15/03. PHN recommended that he contact his PMD, for she did not think it was related to Td and Flu immunization. He reports contacting MD who informed him that he thought it was related to the immunizations. PHN has been unable to get a hold of pt to check status.									Y	10/15/2003	10/16/2003	1	NONE	PUB	PUB	Antihypertensive		History high blood pressure		AK200337	1						1	Dizziness; Fall; Loss of consciousness	FLU3~SANOFI PASTEUR~U1141 AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0820AA~1~~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0211971	11/10/2003	AK	66.0	66		M	10/30/2003	Scratchy throat, fever (felt very hot, didn't take temp), chills for 4 days. Joint pain, every joint in body (still having joint pain). Non-productive cough, deep, causing dry heaves. Last year had exact same symptoms, more severe starting 3 weeks after shot.									N	10/03/2003	10/16/2003	13		PUB	PUB	NONE	NONE	NONE	same~Influenza (Seasonal) (Fluzone)~3~65.00~In Patient	AK200336	1						1	Arthralgia; Cough; Dry throat; Feeling cold; Pyrexia	FLU3~SANOFI PASTEUR~U1141AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211972	11/10/2003	WA	58.0	58		F	10/27/2003	Red and swollen and hard also feverish to touch. Slightly painful (didn't notice until change of clothes). Lesion approximately 20mm in size or she described as the size of a quarter.									Y	10/20/2003	10/21/2003	1		PVT	PVT	Armour thyroid, Bexttra, Prempro	NONE	Post polio syndrome, low back pain, fibromyalgia, menopausal, hypothyroidism			1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site warmth; Pain; Skin ulcer	FLU3~SANOFI PASTEUR~U1076AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211973	11/10/2003	IN	79.0	79		F	11/01/2003	8cm raised area warm, round red lesion, faded red area around red warm area with no heat, not raised.									Y	10/31/2003	10/31/2003	0	NONE	PVT	UNK		NONE	NONE (legally blind)			1						1	Feeling hot; Rash erythematous; Skin ulcer	FLU3~SANOFI PASTEUR~U1079AA~4~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211974	11/10/2003	NC	90.0	90		F	10/30/2003	Client received Td injection right deltoid. Reports redness, itching, warm to touch at site for 2-3 days. Reports she followed up with PMD 10/23/03. Sole complaint at time of report is (pain comes and goes) at injection site. Plans to follow up with PMD if pain contines.				Y					U	10/16/2003	10/16/2003	0	NONE	PUB	PUB	UNK	UNK	NONE			1						1	Injection site erythema; Injection site hypersensitivity; Injection site pain; Injection site warmth; Pruritus	FLU3~EVANS VACCINES~765704~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~SANOFI PASTEUR~U0831AA~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0211975	11/10/2003	NJ	39.0	39		F		Had this flu shot was ok.  The next day was ok, the day after that had full blown flu symptoms.  Coughing, aching neck, back, foot, upset stomach, sore throat.  kept on sleeping.  Felt utterly horrible.  Called the doctor, he did not prescribe medicine. He said it just has to run it's course.  He said you probably got ill from the shot.  Still ill at this time.									N	10/23/2003	10/25/2003	2	UNK	PVT	PVT	NONE	NONE	NONE			1						1	Cough; Influenza like illness; Pain; Stomach discomfort	FLU3~SANOFI PASTEUR~U1076AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211976	11/10/2003	NC	3.0	3		F	10/31/2003	Mild erythematous rash left deltoid.									Y	10/30/2003	10/31/2003	1	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Rash erythematous	FLU3~SANOFI PASTEUR~U1088AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211977	11/10/2003	AZ	89.0	89		F	11/05/2003	Patient developed itchy rash all over body bright red 5 hours after flu shot.  Has had flu shots in past with no reaction.  Patient denies edema.  Saw MD twice so far was on Zyrtec, now on Prednisone and Benadryl.				Y					U	11/02/2003	11/02/2003	0	UNK	OTH	PVT	Diovan; Diltiazem; Covmadin; Levoyxl; Furosimide;	NONE	Had lumpectomy 3 weeks ago.  Diagnosis: Breast Cancer			1						1	Rash pruritic	FLU3~EVANS VACCINES~765140~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0211978	11/10/2003	PA	60.0	60		F	11/05/2003	On 11/05/2003-employee reported 15 day history of swelling in right deltoid where influenza vaccine was administered; expressed concern.									Y	10/21/2003	10/22/2003	1	NONE	OTH	PVT	NONE	NONE	Diabetes			1						1	Injection site oedema	FLU3~SANOFI PASTEUR~U1076AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211979	11/10/2003	CA	44.0	44		F	10/28/2003	Complained of sore right arm, chest pain, rib pain, pain on inspiration.  On right side of body ache all over legs arched.  10/24: Headache general achy pain.  Moved to left and right side of chest and back.  Sunday headache severe.  Had temp to 103 saw MD.  11/02/2003: feeling better had flu per patient.				Y					Y	10/22/2003	10/22/2003	0	NONE	PUB	PUB	NONE	Sinus problem; Migraine	NONE			1						1	Headache; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1091AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211980	11/10/2003	MO	33.0	33		F	10/23/2003	Broke out in a sweat, like a hot flash per patient.  Lasted approximately 2 hours then developed general itching.  Woke up next morning with goose bump like lesions on chest, inner/upper arms and neck, face, jaw and nose.  Stated is now decreasing.  Instructed to notify her physician.									Y	10/22/2003	10/22/2003	0	NONE	PUB	PVT	Prednisone fortunor	NONE	Uterine tumor diagnosis 6 months prior			1						1	Hot flush; Hyperhidrosis; Pruritus; Skin ulcer	FLU3~EVANS VACCINES~765707~7+~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211981	11/10/2003	NC	26.0	26		M	10/30/2003	Local swelling, erythema, and pruritis.  No systemic reaction.									Y	10/28/2003	10/30/2003	2	Physical exam only	MIL	MIL	NONE	Local reaction	NONE			1						1	Injection site erythema; Injection site oedema; Pruritus	FLU3~SANOFI PASTEUR~U1270AA~6~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211982	11/10/2003	AZ				U		Very sick for 36 hours following shot.  Vomiting chills/fever.									Y	10/21/2003	10/21/2003	0	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1142AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211983	11/10/2003	NY	43.0	43		F	10/30/2003	Got flu shot 10/28, 11:30, broke out in hive-like rash on torso. Head and back then eruptions on arms and legs. Recovering at present.									Y	10/28/2003	10/28/2003	0	NONE	PVT	PVT	NONE	NONE	Raynauds Syndrome			1						1	Rash	FLU3~EVANS VACCINES~60872AB~7+~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0211984	11/10/2003	TX	38.0	38		F	10/30/2003	Swelling in area of injection and redness/soreness.									Y	10/16/2003			NONE	OTH	OTH	NONE	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0211985	11/10/2003	NM	54.0	54		F	10/31/2003	Patient states that she received flu shot 10/27 and waited in clinic after it (while getting x-rays).  She states she passed out in car on the way home and got into a motor vehicle accident.  She has not been examined since then-declined office visit and refused triage.  I'm not sure about if she sustained injuries in the MVA.									U	10/27/2003	10/27/2003	0	NONE	PVT	OTH	NONE	Right knee injury	Allergic rhinitis; Arthritis; Obesity; Darvon; Demerol allergies			1						1	Loss of consciousness	FLU3~SANOFI PASTEUR~U1143AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211986	11/10/2003	IL	57.0	58		F	11/03/2003	Patient called into health department stating that within 30 minutes of taking influenza vaccination, developed hives.  RN who took call instructed to take Benadryl and call family MD.									Y	10/21/2003	10/21/2003	0	Patient has PMR which is in remission.  Taking prednisone.	PUB	PVT	Predisone	NONE	PMR in remission			1						1	Polymyalgia rheumatica; Urticaria	FLU3~SANOFI PASTEUR~U1126AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211987	11/10/2003	MI	42.0	42		F	10/29/2003	Swelling in face, lips, eyes, heat-felt like worse sun burn over face.  Now peeling, saw physician 10/28/2003.  Prescribed prednisone.  No difficulty breathing, but would not blow nose.  Not debilitating, but looked terrible.  On 10/23/2003-10/25/2003: used cleaning voy suppositories.  Said reaction was not typical of antibiotic or flu, felt it was more like food.  Felt food, first, then eleocin, lost flu vaccine.				Y					Y	10/23/2003	10/26/2003	3	Medical Center: None	PUB	PVT	Cleocin vag suppositories	Vaginal infection	NONE			1						1	Eye oedema; Face oedema; Pyrexia; Skin exfoliation	FLU3~SANOFI PASTEUR~U1076AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0211988	11/10/2003	CA	69.0	69		F	11/01/2003	36 hours after the flu vaccine, felt intense muscular aches and pain, had fever and chills for 2 days.  Lesser aches and pain lasted for 2 more days.  It was exactly like having a caose of the flu with the exception of the absence of a sore throat and cough.  I was very ill the 1st few days.  Finally felt ok after 5 days.  Follow up: Don't have that info.									Y	10/23/2003	10/24/2003	1	NONE	OTH	OTH	NONE	NONE	Pollen allergies, Asthma, Gout			1						1	Myalgia; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211989	11/10/2003	TX	49.0	49		F	11/03/2003	Next day-arm swollen, vomiting, 101F temperature.  Resolved by following day.									Y	10/21/2003	10/22/2003	1	NONE	OTH	PVT	NONE	NONE	Had milder reaction to flu shot previously	milder reaction to flu shot previously~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Injection site oedema; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1144AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1119M~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0211990	11/10/2003	OH	22.0	22		F	11/03/2003	Swelling, hives, itching, low grade fever, throat. Starting friday morning. Went to urgent care saturday afternoon.  Diagnosis with allergic reaction.  Prescribed prednisone and Zyrtec.				Y					Y	10/30/2003	10/31/2003	1	Strep test: negative	PUB	OTH	NONE	NONE	NONE			1						1	Oedema; Pruritus; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U1131AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212001	11/10/2003	WI	66.0	66		F	11/03/2003	10/25/03 Came to immediate care. Received influenza and pneumonia vaccine 10/23/03; both in left upper arm. On 10/25 came to IC with complaints of redness, pain, 9cmx14cm area of erythema. Slight tender axillary lymphadenopathy. Given keflex 50mg QID for 7 days. On same day of influenza/pnuemonia; got Td in other arm (left); no complaints. Had initial pain at injection site, but on 10/25 developed redness and increasing pain. Vaccines given at her PCP; reaction on weekend so came to I.C.				Y					U	10/23/2003	10/25/2003	2		PVT	UNK	Tylenol; Allegra; Ibuprofen; Lavoxyl; Chlorcon; Zoloft; Desipramine; Deltiazem; Vioxx; Triantenane		PCN			1						1	Injection site erythema; Injection site pain; Lymphadenopathy	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0212009	11/10/2003	TX	42.0	42		M	10/29/2003	Patient received vaccine Monday morning and developed soreness to arm by afternoon with increased swelling and redness by Tuesday. Patient to office Wednesday morning. The follow up received on 11/11/03 states affected area of L arm was 4 x 3. he was treated successfully with Keflex, Advil and ice pack.				Y					Y	10/27/2003	10/27/2003	0	CBC	PVT	UNK		NONE	Recurrent cellulitis; Recent hip replacement			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~07704AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212038	11/10/2003	MS	70.0	70		M	11/03/2003	Swelling and pain in arm when touching it, red splotches on the arm fading now.  Denies fever systemically or in site.									Y	10/31/2003	10/31/2003	0	none	UNK	UNK	none	none	none		MS03095	1						1	Erythema; Pain; Rash maculo-papular; Swelling	FLU3~SANOFI PASTEUR~U1271AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0635N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212142	11/10/2003	TX	56.0	56		F	11/10/2003	Around 10:00p.m. I was going to bed, when removing my clothes I begin shaking out of control, got dizzy /bad headache, then the chills. Had my son take me to the E.R. Was in the hospital for 3 hours also had fever with a very sore arm.  Gave me a shot of Benadryl and med. to bring down fever.  Since fever would not come down started IV. Went home was sick for 1 1/2 days. Toke Tylenol then 4 hours later Motrin to bring fever down and Lortab for pain.				Y					Y	10/28/2003	10/28/2003	0	I don't have these	PUB	PVT	take daily--Paxil,furosemide,avandamet,zestril,tricor,premarin,prevacid,norvasc,aspirin,ambien	none	high blood pressure,depression,diabetes,heart,stomach			1						1	Chills; Dizziness; Headache; Pain; Pyrexia; Tremor	FLU3~EVANS VACCINES~765703~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0865N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212143	11/10/2003	CT	76.0	76		M	11/10/2003	guillan barre-patient is currently in a medical ICU. 60-day follow up on 01/22/04: The pt has not recovered from the adverse events. Pt has still not regained the ability to breath on his own, and still cannot more his lower extremities. Pt can move upper extremities, but not on a constant basis.  He is still in our medical intensive care unit and will be transferred to a long term care facility in the near future. Discharge summaries state vomit, abdominal pain, pneumonia, asthenia, paresthesia, facial paralysis, speech disorder, fever, heart arrest, apnea;  Corneal ulcer, conjunctivitis, keratitis, rsh, ventricular tachycardia. msv					Y	10			N	10/15/2003	10/29/2003	14	EMG Discharge summary states hypokalem, CSF abnormal. msv	UNK	UNK			Discharge summaries state angina, hyperlipedemia, arterial anomaly, prostate disorder, hypertension;  Choelithiasis, acute brain syndrome. msv			1						1	Abdominal pain; Apnoea; Asthenia; CSF test abnormal; Cardiac arrest; Conjunctivitis; Facial palsy; Guillain-Barre syndrome; Hypokalaemia; Keratitis; Paraesthesia; Pneumonia; Pyrexia; Rash; Speech disorder; Ulcerative keratitis; Ventricular tachycardia; Vomiting	FLUX~UNKNOWN MANUFACTURER~U1270AA~1~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0212144	11/10/2003	AL	26.0	26		F	11/10/2003	I suffered extreme pain in the arm where vaccine given that radiate to the shoulder and then the neck area.  All became sore to the touch and the neck pain hendered daily activity.  The neck pain resulted in a trip to mu chiropractor today for adjustment.  The arm is still sore to the touch.  I also suffered from mild aches which I had been advised about.  I did have fluxuations ffrom hot to cold.  Mostly on the cold side. I also had to use my albutoral inhaler to ellivate the tightness in my chest									Y	11/08/2003	11/08/2003	0		UNK	PVT	albutorla inhaler	none	Allergies to erithomyacin, shellfish, molds and pollens, milk but not other dairy			1						1	Chest discomfort; Injection site pain; Neck pain; Pain; Shoulder pain	FLUX~UNKNOWN MANUFACTURER~~1~ID~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212146	11/10/2003	AR	36.0	36		F	11/10/2003	Mild difficulty breathing, dizziness and slight nausea.  VERY similar to reactions I have had to anticoagulants...except no fainting at least not yet.  Minor chest pain also.									U	11/10/2003	11/10/2003	0		PUB	PVT	Ortho Tri-Cyclen	None				1						1	Chest pain; Dizziness; Dyspnoea; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212147	11/10/2003	MO	53.0	53		M	11/03/2003	C/O vomiting/diarrehea approx. 4 hours after receiving flu shot.  Fever, aches, same evening. Fever, vomiting resolved 11-02-03 evening. Imodium AD controlling diarrhea, still some aches.									Y	10/31/2003	10/31/2003	0		UNK	UNK	singular, combivent, advair, flonase', guarfenesin	none known	asthma, emphysema, COPD		MO200393	1						1	Diarrhoea; Pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1094AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212150	11/10/2003	MD	55.0	55		F	11/10/2003	heavy rash on upper body with hives.  Treatment with prednisone 10 mg tablets for 9 days.  Total tablets - 21				Y					Y	11/06/2003	11/07/2003	1		PUB	PUB						1						1	Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0212055	11/11/2003	MI				F		Inflammation of arm at site of injection.									Y	10/14/2003	10/14/2003	0		PVT	PVT	Imitrex; Vioxx;	Left arm swelling	Polycystic kidneys; HTN; Kypokinesia			1						1	Injection site inflammation	FLUX~UNKNOWN MANUFACTURER~763484~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212056	11/11/2003	OR	60.0	60		F	11/10/2003	Initial: redness, heat and swelling at injection site with induration 10 cm. Weakness of arm/hand grip. Late: Following morning: dizzy, diaphoresis, followed by syncope. Fell and injured ankle.				Y					Y	11/07/2003	11/07/2003	0	Ankle film, EKG normal	PVT	OTH	Motrin, Norvasc	Cold-like illness within 2 weeks	Sjogren's, hypertension, Allergy: sulfa, lidocaine			1						1	Dizziness; Fall; Hyperhidrosis; Injection site erythema; Injection site induration; Injection site oedema; Injection site warmth; Muscular weakness; Syncope	FLU3~SANOFI PASTEUR~U1127AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1196M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212057	11/11/2003	MT	38.0	38		F	11/10/2003	Grapefruit sized localized swelling with redness, pain, heat at injection site, duration 4 days. Responded to antiinflammatories.									Y	11/06/2003	11/06/2003	0		OTH	PVT	NONE		Crohn's			1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLU3~EVANS VACCINES~765852~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212058	11/11/2003	IA	71.0	71		F	11/06/2003	Received first ever flu shot. Next day felt ill, chilled, tachycardia. Following day broke out in classic whole body drug-rash, and was seen in office. No further treatment needed.				Y					Y	11/03/2003	11/04/2003	1	NONE	PVT	PVT		NONE	NONE			1						1	Feeling cold; Malaise; Rash; Tachycardia	FLU3~SANOFI PASTEUR~U1079AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212059	11/11/2003	FL	69.0	69		F	11/10/2003	24 hours after vaccination administered right arm became red, swollen, warm, and sore down into her elbow.				Y					Y	11/06/2003	11/07/2003	1		PVT	PVT	Glucophage, Zyrtec, Glucotid XL, Lopressor, Mobic, Magox, Synthroid, Pravachol, Bestril, ASA, B12 inj.	NONE	Hypothyroidism, menopausal syndrome, HTN, diabetes, B12 deficiency; allergies to Bextra			1						1	Erythema; Feeling hot; Oedema peripheral; Pain	FLU3~EVANS VACCINES~765143~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0869N~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212060	11/11/2003	WA	4.0	4		F	11/07/2003	Right shoulder 4.5 x 6cm red and warm to touch, + ROM.				Y					Y	11/04/2003	11/06/2003	2		PVT	UNK		NONE	NONE			1						1	Erythema; Feeling hot	DTAP~SANOFI PASTEUR~C1385AA~UNK~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1091AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W1002~UNK~IM~LA~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~1237M~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0212062	11/11/2003	MD	71.0	71		F	11/10/2003	Pt c/o throat feeling tight. Epinephrine 0.3cc of 1:1000 sq left arm. 911 call for ER for evaluation, via ambulance. Released with meds.				Y					Y	11/07/2003	11/07/2003	0		OTH	PVT						1						1	Throat tightness	FLU3~EVANS VACCINES~765796~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212063	11/11/2003	NY	46.0	46		F	11/10/2003	Approx 5-6 hours post flu vax, pt experienced generalized body itching and burning sensation, no rash. Itching and burning worsened during the night. Pt self-medicated with Benadryl PO. From 10/29 to 10/31 pt unable to attend work because itching worsened, especially palms and soles on fire with itching. On 11/1 pt developed rash on both arms and on back. Rash looked like chickenpox-type rash. Rash was very painful but resolved on evening of 11/2. Itching became intolerable on 11/3 (pt missed work) and pt developed joint pain in knees, wrists and hands (pt unable to drive). Pt went to ER on 11/4 and was given Prednisone (40mg) po for 5 days. 11/4 knees became swollen. On 11/8 and 11/9 right wrist pain. On 11/10 no meds, no itching.				Y					Y	10/28/2003	10/28/2003	0	Whole count=10.9, ESR=normal. AMA=negative, other results pending. Tests done: CBC, ESR, AMA, rheumatoid factor, Coxackie A and B, Parovirus FSM.	PVT	OTH	Aleve and Lamisol	NONE	Allergic to: penicillin, Cephoxatin, Streptomycin			1						1	Arthralgia; Oedema; Pain; Pruritus; Rash vesicular; Skin burning sensation	FLU3~EVANS VACCINES~765795~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212064	11/11/2003	MO	68.0	68		F	11/10/2003	Shot given 10/16. 10/17 Rash developed. 10/20 Rash was worse - upper back, bilateral and upper arms and right thigh. Pt went to Dr office and was prescribed some medicine. Went back to Dr office on 10/27 Rash, felt hot to pt. Biopsy was done at site of reaction.				Y					U	10/16/2003	10/17/2003	1	See attached documents.	OTH	OTH	UNK	NONE	NONE			1						1	Feeling hot; Rash	FLU3~EVANS VACCINES~765146~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212065	11/11/2003	WV	42.0	42		M	11/04/2003	24 hours after receiving #4 dose Anthrax, developed oral sores, perhaps Lichen planus or candidiasis.				Y					Y	11/01/2003	11/02/2003	1	NONE	MIL	MIL	Zoloft, Nexium, Clarinex	NONE	NONE	~Anthrax (Biothrax)~~41.00~Patient		1						1	Mouth ulceration; Arthralgia; Fatigue; Headache; Mouth ulceration; Vision blurred	ANTH~EMERGENT BIOSOLUTIONS~FAV076~4~~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1269AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|ANTH~EMERGENT BIOSOLUTIONS~FAV076~4~~RA~ANTHRAX (BIOTHRAX)~2|FLU3~SANOFI PASTEUR~U1269AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0212065	11/11/2003	WV	42.0	42		M	11/04/2003	Fatigue, headache, joint pain, blistering in mouth, blurred vision.				Y					U	11/01/2003	11/02/2003	1		MIL	MIL	Zoloft, Nexium, Clarinex			~Anthrax (Biothrax)~~41.00~In Patient		1						2	Mouth ulceration; Arthralgia; Fatigue; Headache; Mouth ulceration; Vision blurred	ANTH~EMERGENT BIOSOLUTIONS~FAV076~4~~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1269AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|ANTH~EMERGENT BIOSOLUTIONS~FAV076~4~~RA~ANTHRAX (BIOTHRAX)~2|FLU3~SANOFI PASTEUR~U1269AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0212067	11/11/2003	IN	67.0	67		M	11/10/2003	Diffuse swelling and redness of left upper extremity, down to wrist.				Y					U	11/07/2003	11/07/2003	0	NONE	PVT	OTH	Glucophage, Lipitor, Monopril, Protonix, Sinemet	NONE	DM, Hyperlipidemia, Parkinsons			1						1	Erythema; Oedema peripheral	FLU3~EVANS VACCINES~765851~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0869N~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212068	11/11/2003	WA	19.0	19		F	11/06/2003	Throat swelled up and had difficulty breathing. Required 0.5cc Epi, Benadryl, Zantac, Prednisone.				Y					Y	11/05/2003	11/05/2003	0		PUB	PUB			NONE			1						1	Dyspnoea; Pharyngeal oedema; Throat tightness	FLU3~EVANS VACCINES~765139~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212069	11/11/2003	MA	47.0	47		F	11/10/2003	Follow up on 11/13/2003: Rash started as red dot on left hand, progressed to right forearm was itchy.  Prescribed Benadryl/Prednisone/resolved 1 week.				Y					Y	11/03/2003	11/04/2003	1		PUB	PVT			PCN			1						1	Rash pruritic	FLU3~SANOFI PASTEUR~U1137FA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212070	11/11/2003	NC	38.0			F	11/07/2003	Follow up on 11/17/2003: Became lightheaded, dizzy, became short of breath-lips, tongue became swollen.  Given O2, Benadryl injection-to ER where she recovered with more medical intervention.  Diagnosis: Anaphalysis.				Y					Y	11/07/2003	11/07/2003	0	At ER	PVT	PVT	Has had multiple vaccinations	Her son with viral syndrome	NONE			1						1	Anaphylactic reaction; Dizziness; Dyspnoea; Face oedema; Tongue oedema	FLU3~EVANS VACCINES~765484~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212071	11/11/2003	WV	8.0	8		M	11/07/2003	Redness and soreness at left deltoid administration site. Oral area of involvement, 18cm x 16cm. No respiratory distress. No orofacial swelling.									U	11/05/2003	11/06/2003	1	NONE	PVT	PVT	NONE	NONE	Attention deficit disorder			1						1	Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~C1134BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0947N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212072	11/11/2003	OH	50.0	50		F	10/27/2003	Patient states approximately 5 minutes after received shot her hands started itching, developed hives on arms and abdomen, eyes and lips swollen, fingers swollen to twice their size. She states her throat felt like it was closing. Went immediately to ER, treated and released. Instructed her to follow up with own physician.					Y				U	10/24/2003	10/24/2003	0		UNK	UNK						1						1	Eye swelling; Face oedema; Oedema peripheral; Pruritus; Throat tightness; Urticaria	FLU3~SANOFI PASTEUR~U1079AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0212073	11/11/2003		49.0	49		F	10/24/2003	Patient received Pneumovax (23 valent to left arm).  Lot # 0676M, 0.50cc 10/22/2003.  Patient developed arm pain and swelling.									U	10/22/2003	10/22/2003	0		OTH	OTH	NONE	NONE	Diabetes Mellitus			1						1	Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~U1266AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0676m~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212074	11/11/2003	DC	51.0	51		F	10/31/2003	Prolonged soreness left upper arm 12 days post flu vaccine.  Intermittent localized soreness 5-6/10 pain scale.  Increased to 10/10 at night.  Wakes her from sleep.  No decreased range of motion, no nausea, fever, chills, arthralgias/myalgias.  Normal appetite and activity.  Prescription with Motrin 600mg every 6-8 hours.  Symptoms relieved in 3-4 days.				Y					Y	10/16/2003	10/17/2003	1	NONE	MIL	MIL	Lasix; Cardizem	NONE	Hypertension			1						1	Injection site pain; Sleep disorder	FLU3~SANOFI PASTEUR~U1078AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212075	11/11/2003	WA	40.0	40		F	11/05/2003	Right side of face and head: Gradual severe pain persisted for a number of days leading up to the onset of Bells Palsy-visited GP and neurologist and is on Prednisone and Valocyclovin now.  Hopefully recovering. The medical record received on 3/23/04 states weakness rt eye closure, numbness, difficulty speaking, eye tearing, taste diminished, headaches, and anxiety.				Y					U	10/21/2003	10/21/2003	0	NONE	OTH	PUB	NONE	NONE	Sinus headaches, type one oral herpes			1						1	Anxiety; Dysgeusia; Eye disorder; Facial palsy; Headache; Hypoaesthesia; Lacrimal disorder; Pain; Speech disorder	FLU3~EVANS VACCINES~765670~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212076	11/11/2003	NY	65.0	65		F	11/05/2003	Patient developed warmth and redness surrounding injection sites on left arm.  Started 11/04/2003.				Y					Y	11/03/2003	11/04/2003	1	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Feeling hot; Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U1081AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0530N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212077	11/11/2003	CA	0.2	0	.7	M	10/29/2003	Around 16:30, mom noticed that he had problems with balance while sitting between her legs.  Couldn't sit alone, not able to bring to stand, went to sleep at 19:00.  At 21:00 able to site up by self and acting normal.				Y					Y	10/28/2003	10/28/2003	0	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Balance disorder	FLU3~SANOFI PASTEUR~U1134BA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212078	11/11/2003	OH	63.0	63		U		Baseball size lump-red around injection site.  Left deltoid pneumonia.									U	10/28/2003	10/29/2003	1	Did not return call	PUB	OTH	NONE	NONE	NONE			1						1	Injection site erythema; Injection site mass	FLU3~SANOFI PASTEUR~U1098AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1740N~2~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212081	11/11/2003	NY		60		M	11/06/2003	Began with pain immediately when he got the vaccination.  Had redness develop about 12 hours later.									Y	11/04/2003	11/04/2003	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Erythema; Pain	FLU3~SANOFI PASTEUR~U1139AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0864N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212082	11/11/2003	NY	38.0	34		U		Redness and pain with swelling in right upper arm.				Y					Y	10/30/2003	10/31/2003	1	NONE	PVT	PVT	Nexium; Effexor XR	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U1139AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0864N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212083	11/11/2003	MD	28.0	28		F	11/04/2003	Large red area that was warm and painful for approximately 72 hours.									Y	10/31/2003	11/01/2003	1	NONE	PUB	PUB	Lexapro 10mg; Zantac 300mg	NONE	NONE			1						1	Erythema; Feeling hot; Pain	FLU3~EVANS VACCINES~765797~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212085	11/11/2003	NE	35.0			M	11/03/2003	MD reported patient experienced a migrating arthritis, muscle spasms of the forearm and an inability to grasp anything.  Resolved in 1 day.  Started hours after flu shot.				Y					Y	10/20/2003	10/20/2003	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Arthritis; Asthenia; Muscle spasms	FLU3~EVANS VACCINES~765273~2~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212086	11/11/2003	IA	56.0	56		F	11/04/2003	Client states arm was red from injection site to elbow, edema, sore, itchy first day, denies any fever or chills.									Y	10/28/2003	10/28/2003	0	NONE	PUB	OTH	NONE	NONE	NONE			1						1	Injection site erythema; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus	FLU3~EVANS VACCINES~765854~6~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0256N~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212087	11/11/2003	IL	29.0	29		F	11/03/2003	Approximately 15 minutes after vaccine was administered, received a call from personnel that patient stated that her chest felt heavy with increased respirations, lightheadedness.  Brought to clinic and put into main surgery room.  Complained of feeling very hot.  Right leg numb and feels very tired now.  Client presents with assist of x1 face increased flushed.  Respiratory of 30.  Client put on table with legs elevated.  Blood pressure 126/78.  Pulse apical: 92 reg; Radial 80 reg.  RN called for assistance if needed.  Husband called.  10:50, client states chest still feels a little heavy offered to call ambulance to have her transported to ER.  Client declined.  BP: 120/80; Respiratory 16; Pulse 72 reg (radial); Color good at this time; Skin warm and dry; Alert/oriented x 3.  Capillary refill in 3 sec/client sitting drinking H2O.  Husband here at 11:00 assisted out and going to see physician.  Husband advised of incident.  Client walk out with husband-advised them to call me sometime tomorrow.  11:10: RN notified via phone.									Y	11/03/2003	11/03/2003	0	NONE	PUB	OTH	NONE	NONE	NONE			1						1	Chest pain; Dizziness; Dry skin; Fatigue; Flushing; Respiratory rate increased	FLU3~EVANS VACCINES~765712~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212088	11/11/2003	CA	15.0			M	11/06/2003	Patient received flu vaccine at this facility during a flu clinic open to the public.  Three days later he experienced fever, headache, nausea/vomiting, diarrhea, muscle aches.									Y	11/01/2003	11/04/2003	3	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Diarrhoea; Headache; Myalgia; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1271AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212090	11/11/2003	NY	56.0	56		F	11/04/2003	7cm x 3.5cm cellulitis at injection site.  24 hours after vaccine administered.									Y	11/03/2003	11/04/2003	1	NONE	PUB	OTH	Caltrate; Bextra; Toprol XL; Citruel; Prempro	NONE	NONE			1						1	Cellulitis; Injection site reaction	FLU3~EVANS VACCINES~765875~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212091	11/11/2003	WA	3.0	3		M	11/04/2003	Vomiting, fever 103; back pain; wheezing.									Y	10/29/2003	10/29/2003	0	Urinalysis: Normal;	PVT	PUB	Albuterol	NONE	Asthma			1						1	Back pain; Pyrexia; Vomiting; Wheezing	FLU3~SANOFI PASTEUR~U1091AA~4~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212092	11/11/2003	CO	72.0	72		F	10/30/2003	Lt deltoid red, swollen c/o fever and HA.				Y					Y	10/29/2003	10/30/2003	1		PVT	PVT	Lipitor, Estradol, Epiear	NONE	PCN			1						1	Erythema; Headache; Oedema peripheral; Pyrexia	FLU3~EVANS VACCINES~765957~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0256N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212094	11/11/2003	WA	8.0	8		F	11/04/2003	Recurrent vomiting, low grade fever, muscle pains, leg numbness and weakness.									Y	10/29/2003	10/30/2003	1	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Hypoaesthesia; Muscular weakness; Myalgia; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1091AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212095	11/11/2003	CA	57.0	57		F	10/31/2003	Approximately 24 hrs after flu vaccination L deltoid, experienced tenderness to glands-neck bilat-and L upper arm tenderness. Mild tenderness to L armpit. Tenderness to all areas resolved 10/30/03.									Y	10/23/2003	10/24/2003	1		PVT	PVT		NONE	NONE			1						1	Tenderness	FLU3~EVANS VACCINES~765876~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212096	11/11/2003	IA	2.0	2	.2	F	11/03/2003	Onset middle of night crying-by am favoring R leg with no hx of injury or cold sx's or break in skin-no hx of fever. Resolution 48 hrs.				Y					Y	10/28/2003	10/31/2003	3	CBC wnl, ESR 30	PVT	PVT	NONE	Follow up for OM	Asthma			1						1	Agitation	FLU3~SANOFI PASTEUR~U1080AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212097	11/11/2003	LA	5.0	5		M	10/31/2003	Temp of 103-105 orally. Hurts all over, trouble keeping fever down mom states.									Y	10/30/2003	10/31/2003	1		PVT	PUB	NONE	NONE	NONE			1						1	Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1094AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212098	11/11/2003	WA	50.0	48		F	11/04/2003	L arm red, hot 24 hrs x inj.									Y	11/01/2003	11/02/2003	1	NONE	OTH	PVT	Clonazepam, Warfaun, Fluoxetine	NONE	NONE			1						1	Erythema; Feeling hot	FLU3~SANOFI PASTEUR~U1139AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212099	11/11/2003	CA	72.0	72		F	10/31/2003	Reports soreness/redness at shot site arm, wheezing, SOB began approx 3 hrs post IZ continuing throughout night-is recovering this am.									Y	10/30/2003	10/30/2003	0	NONE	PUB	PUB	Inhaler	NONE	Asthma	Prolonged arm soreness~Td Adsorbed (no brand name)~1~72.00~In Patient		1						1	Dyspnoea; Injection site erythema; Injection site pain; Wheezing	FLU3~EVANS VACCINES~765143~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212100	11/11/2003	PA	50.0	50		F	11/03/2003	After receiving the flu with Pneumovac shots, approximately 36 hrs I began having severe foot and ankle pain and swelling, was bed ridden, could not walk or stand because of pain and swelling. Had chills, no appetite. Went to ER, gave pain shot started on Neurontin. Had visiting nurse. Still have home PT 2xwk. Still after 1 mo having foot pain and swelling.  Follow up on 12/03/03: My PCP would have that info.				Y					N	10/07/2003	10/08/2003	1		PVT	OTH	Aldactone, Bumex, Dexamethason, Prevacid, Lopressor, baby Aspirin, Percocet, Slow-Mag, multivitamin, Omega, CranActin		Diabetes type II insulin dependent, congenital adrenal hyperplasia, anxiety/panic disorders, depression, hypothyroidism, fibromyalgia, neuropathy left leg and two left toes, carpal tunnel syndrome both wrists and arms, angina pectoria, eating disorder, GERD, frequent bladder infections and cellulitis of the abdominal skin area, high cholesterol. Allergies: Thiazide elevated LFTs, Luvox elevated LFTs, Stelizine severe visual changes with instability. Adverse reactions: Zocor severe muscle pain, Rezulin, Frandin, Keflex, Coozar, Cardizem, Celebrex, Wellbutrin, Vioxx, Tequin, Avelox and Actos			1						1	Abasia; Anorexia; Arthralgia; Chills; Hypokinesia; Oedema peripheral; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212101	11/11/2003	FL	53.0	51		F	10/30/2003	Next day red ring around site R arm-10/29/03 red area increased swelling, hot, pain shoulder into neck. MD-Keflex ordered.				Y					Y	10/21/2003	10/22/2003	1		PUB	PVT	Paxil, multivit					1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth; Neck pain	FLU3~SANOFI PASTEUR~U1147AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0740N~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212102	11/11/2003	FL	69.0			F	10/30/2003	States both arms hurt-ache to bones. L arm-flu bruised R arm-Pneumonia warm to touch-pt states knot-none-felt-went to MD.				Y					U					PUB	PVT	Actose qd, Cardizem, reg insulin, Lortab		DM, HTN			1						1	Bone pain; Contusion; Feeling hot; Pain	FLU3~SANOFI PASTEUR~U1147AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0740N~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212103	11/11/2003	MO	77.0	77		F	11/03/2003	10/28/03 received influenza vaccine c/o feeling nauseated during car trip home at 4:30pm. Next day, c/o nausea, chills, fever increase 101 deg, extreme fatigue, muscle aches. 11/3/03 still feels dizzy, nauseated, joint pain.									N	10/28/2003	10/28/2003	0		OTH	OTH	Cortisone, Acetate, Flonef, Thyroid, vit D		Addison's disease, hyperthyroid disease			1						1	Arthralgia; Chills; Dizziness; Fatigue; Myalgia; Nausea; Pyrexia	FLU3~EVANS VACCINES~765181~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212104	11/11/2003	CT	77.0	77		F	11/03/2003	Pt developed pain on the left arm/shoulder on the following day, followed by nausea, dizziness, profound weakness, hot/cold seats; no fever no chills, no SOB, no cough.									Y	10/30/2003	10/31/2003	1	Pending	PVT	PVT	Insulin, synthroid, Zestril, Lipitor	NONE	Diabetes mellitus, HTN, hyperlipidemia, hypothyroidism, allergy			1						1	Asthenia; Dizziness; Hyperhidrosis; Nausea; Pain	FLU3~EVANS VACCINES~765710~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212105	11/11/2003	ND	4.0	4		F	11/03/2003	10/28 hands and feet swollen, few hives-itchy. 10/22, 10/24-diarrhea, vomiting. 10/27 diarrhea.				Y					Y	10/21/2003	10/22/2003	1	Neg rapid strep 10/28	PVT	PUB		NONE	NONE			1						1	Diarrhoea; Oedema peripheral; Pruritus; Urticaria; Vomiting	FLU3~SANOFI PASTEUR~U1095AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212106	11/11/2003	MI	69.0	69		F	11/01/2003	Swelling, erythema, induration, fever 102.5 began treatment with Keflex 1000mg tid for cellulitis/fasculitis. The follow up received on 12/23/03 states the pt comes in today for follow-up visit after having had a local reaction to her Pneumovax vaccination. She had been seen on November 1 at our office by Dr who diagnosed a mild cellulitis. The pt had episode of fever with chills prior to her arm swelling and having increasing area of erythema along her right upper arm. She was treated with Keflex 1g t.i.d. for ten days. She said that she has tolerated this medicine well and that she has noticed marked improvement in her right upper arm. She now just has very small area of mild erythema present on her right upper arm.  Cellulitis of right upper extremity, resolving with current treatment.				Y					U	10/29/2003	10/30/2003	1		PVT	OTH						1						1	Cellulitis; Erythema; Oedema; Pyrexia	FLU3~EVANS VACCINES~765855~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0819M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212107	11/11/2003	HI	1.25	1	.3	M	10/31/2003	2 days following receipt of immunization developed palpable fevers. The 3rd night had generalized seizure associated with fever 102.5. Seen in ER, no source of fever found. Since discharge from ER, no further seizures or fever. Blood cultures still pending. Treated symptomatically.				Y					Y	10/27/2003	10/30/2003	3	Urinalysis normal, Na 132, Glu 115, Ca 9.4	PVT	PUB	Flouride	NONE	35 wk prematurity, otherwise negative			1						1	Convulsion; Pyrexia; Red blood cell abnormality	DTAP~SANOFI PASTEUR~U0996CA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1141AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UA877AA~4~IM~LL~HIB (ACTHIB)~1	USA	Emergency room visit	Influenza
0212108	11/11/2003	MI	4.0	4		F	10/31/2003	1 day after vaccine, pt developed hives all over her entire body. Mother called ER who recommended Benadryl. She presented to PCP office for evaluation, confirmed Benadryl 25mg qid through 10/27/03.				Y					Y	10/21/2003	10/22/2003	1	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Urticaria	FLU3~EVANS VACCINES~765502~1~IM~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212109	11/11/2003	VT	30.0	30		F	11/04/2003	Pt presented 45 minutes after vaccination was at her work place. Reports discomfort/pain in chest and right axilla, throat tightness, and is very pale. Medicated with Benadryl 50mg IM at 1245 by RN. Color improved. throat tightness lessened within 5 mins. Reports first onset of symptoms was within 20 mins of dose. Improved by 1330.									Y	11/04/2003	11/04/2003	0		OTH	PVT	Depoprovera	NONE	One sibling has egg allergy. Pt tolerate eggs.			1						1	Chest pain; Pain; Pallor; Throat tightness	FLU3~EVANS VACCINES~765954~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212115	11/11/2003	ND	49.0	49		F	11/04/2003	Redness and swelling, pain from injection site to within 1-2 of elbow. Pt used cold packs and Tylenol, lasted up to 1 week.									Y	10/22/2003	10/22/2003	0	NONE	PVT	UNK		NONE	PCN, codeine, ASA		ND0318	1						1	Injection site erythema; Injection site oedema; Pain	FLU3~SANOFI PASTEUR~U1076AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212151	11/11/2003	NV	43.0	43		F	11/11/2003	I had soreness at the site of the flu-shot injection (left arm) which soon spread to include the entire arm and hand by the following day, lasting for one day, then subsided but *moved* to the right arm, with pain being so severe I could almost scream if I didn't exert so much so control over such things - it seems to be moving from limb to limb - the pain is migratory and SEVERE! It is continuing right now.									U	11/05/2003	11/06/2003	1		UNK	UNK	I take these drugs for my thyroid: Synthroid and Cytomel and Toprol-XL for high blood pressure.	Hypo-thyroidism and High Blood Pressure (no other illnesses) it is important to note however, that I have had the flu shot in previous years with no reaction (and I'm not allergic to eggs)	Hypo-thyroidism and HBPressure			1						1	Injection site pain; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212153	11/11/2003	CA	78.0	78		U		This subject is a 79 year old male who died while enrolled in the RSV 11 study. The subject received RSV vaccine or Placebo and influenza vaccine on 10/25/02. Investigator is waiting for medical records. The death was reported by the investigator as not related to the study vaccine. A 15-day follow up report received 11/13/2003 adds no new info. The hospital discharge summary received on 11/20/03 states pneumonia, and pulmonary hypertension. A follow-up received 11/20/2003 adds: Acute pneumonia, pulmonary HTN.	Y								N	10/25/2002				UNK	UNK	RSV/Placebo; Prednisone; Lasix; Spironolactule; Arpamil, Fosamax, Septha		Emphysema, CHF, COPD, interstitial lung fibrosis, diabetes type 2.		200302839	1						1	Lung disorder; Pneumonia; Pulmonary hypertension	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0212167	11/11/2003	OH	44.0	44		M	11/11/2003	Arm soreness at site of flu shot still persists after 6 days									N	11/05/2003	11/05/2003	0		UNK	PVT	Zoloft, Antebuse	None	None			1						1	Injection site pain	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212168	11/11/2003	NY	60.0	60		F	11/11/2003	In 24 hrs had very large melon size indurated lesion that was purpuric in nature warm but not tender to the touch at the site of the injection. Looked like an arthus reaction seen in immune complex disorders involved only the skin at the injection site Not uricarial.				Y					Y	10/28/2003	10/29/2003	1		PVT	PVT	Multiple including Insulin Asthma meds	None	Asthma  Diabetes			1						1	Injection site induration; Injection site warmth; Skin ulcer; Type III immune complex mediated reaction	FLU3~SANOFI PASTEUR~U1139AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212169	11/11/2003	IL	80.0	80		F	11/11/2003	monday  - pt was given flu shot tuesday - pt awaken with swollen face and top lip         - dr was called and dr prescribed benadryl wednesday - swelling continued and spreaded to bottom lip.  swelling was very very large. pt was taken to the emergency room.  Drs there started pt on a steroid for 7 days. Meds currently taking are : 1. Amiodarone   200mg 2. Metoprolol   100mg 3. Warfarin Sod  7.5mg 4. Triamterene  37.5mg 5. Monopril     40mg 6. Reminyl       8mg 7. Zyprexa     2.5mg 8. Levoxyl     0.25mg pt had also been taking aricept 5mg the prior week.  pt discontinued the use of aricept due to severe nausea.				Y					Y	09/01/2003	09/02/2003	1		UNK	UNK						1						1	Face oedema; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0212170	11/11/2003	IN	40.0	40		M	11/11/2003	Patient expired 11/9/03  Cause of death  following autopsy:  Fatal Heart Disease (Athero- sclerotic heart disease) Fatal Arrythmia Diabetic Related	Y	11/09/2003							N	11/07/2003	11/08/2003	1		UNK	UNK	Insulin Oral diabetic agents Calcium Channel blocker?	None reported	Diabetes Hypertension			1						1	Coronary artery atherosclerosis	FLU3~EVANS VACCINES~765797~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0212172	11/11/2003	TX	32.0	32		F	11/11/2003	I recieved the Influenza Vaccine yesterday, November 10, 2003 @ 12:00 pm. Within the hour the site of injection was red, swollen, hot, and itching. I have had a temperature of 100-101.4 with serious nausea, and my face feels very flushed. I have taken anti-nausea med. and Tylenol. Nothing seems to help. It has been aproximately 31 hours.									N	11/10/2003	11/10/2003	0		PVT	PVT	Prevacid 30mg Zyrtec D Celexa 40mg x 2 Adderal XR	None	seasonal allergies			1						1	Flushing; Injection site erythema; Injection site hypersensitivity; Injection site swelling; Injection site warmth; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212173	11/11/2003	TX	40.0	40		F	11/11/2003	localized swelling, site raised warm to touch, itches and is painful to touch									Y	11/09/2003	11/09/2003	0		PUB	PUB						1						1	Injection site pain; Injection site swelling; Injection site warmth; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212158	11/12/2003	MD	47.0	47		M	11/11/2003	Mild cellulitis right shoulder.									Y	11/05/2003	11/05/2003	0		PVT	PVT	Glucotrol; Glucophage; Estril; Tricor; Actos; Aciphex	Depression; DM; Hyperlipidemia	Depression; DM; Hyperlipidemia; Sulfa; Tussionex			1						1	Cellulitis	FLU3~SANOFI PASTEUR~U1090AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0740N~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212159	11/12/2003	WI	79.0	79		F	11/11/2003	Pustular rash clustered on back of legs, dorsally on both feet, toes, arms, and back. Required dermatology consult and course of oral steroids (Prednisone).				Y					Y	10/02/2003	10/07/2003	5	WBC baseline 6.7; elevated to 11.4 on 10/7/03.	PVT	PVT	Coumadin	NONE	Atrial fib; All: ACE inhalants			1						1	Rash pustular; White blood cell count decreased	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212160	11/12/2003	WI	89.0	89		M	11/11/2003	Small, red, macular rash on arms, back, and chest. Follow up clinic visit. No treatment; resolved.									Y	10/09/2003	10/23/2003	14		UNK	PVT	Coumadin	NONE	Atrial fib; NKDA			1						1	Erythema; Rash macular	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212161	11/12/2003	WI	32.0	32		M		32 year old male with lung cancer vaccinated on 10/16/03. Given Taxol/Carboplatin on 10/16/03. Presented to ED with urticaria, eyes swollen shut on 10/30/03. Unclear association with flu vaccine. No other new meds.				Y					Y	10/16/2003	10/30/2003	14		PVT	PVT	Taxol; Carbo; Coumadin	Lung Carcinoma	NKDA			1						1	Eye swelling; Urticaria	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212162	11/12/2003	CA	52.0	52		F	11/10/2003	Received flu shot Thursday. We saw patient 10/29/03 with fever, sore throat. Left arm where she got flu shot is very sore and is unable to lift left arm at all. Tender to touch. On exam, serious otitis media. Positive pain posterior bursa left arm.									Y	10/23/2003	10/26/2003	3	Throat culture negative; CXR WNL	UNK	UNK		NONE	Templar Pubs			1						1	Injection site pain; Joint range of motion decreased; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U1099AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212176	11/12/2003	TN	44.0	44		F	11/12/2003	Runny nose, stuffy nose, sneezing, fatigue, scratchy throat									U	11/08/2003	11/10/2003	2		UNK	PVT	FloNase	None	Allergic to sulfa and thimersol			1						1	Fatigue; Nasal congestion; Rhinorrhoea; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~unknown~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0212258	11/12/2003	IL	46.0	46		F	11/12/2003	DIZZINESS									U	11/12/2003	11/12/2003	0	N/A	UNK	PUB	NONE	NONE	NONE			1						1	Dizziness	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212259	11/12/2003	MN	0.0	56		F	11/12/2003	the afternoon after the shot, tingling itching in areas I have had previous cold sores, plus the outside left side of nostril. By the next day cold sore appearing vesicals occured, by evening the nose was swollen and red, as well as a sort of channel area from the eye to nose, and a swelling under the left jaw area.  The area on my shoulder where I had shingles over 10 years ago was experiencing some shooting pains.  Treated with Zovirax per advice of my dentist as Dr. was out of town.  Did go to clinic Monday was given diagnosis of Rosecia and prescribed a tube of ointment.   Did get a 2nd opionion due to severe itching and pain, who thought it was herpes and said to continue Zovirax.									Y	10/22/2003	10/22/2003	0		PVT	UNK						1						1	Blister; Erythema; Herpes simplex; Pain; Paraesthesia; Pruritus; Rosacea; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212260	11/12/2003	NC	43.0	43		M	11/12/2003	10/7/03- received anthrax #1, together with influenza, typhoid, hep B #1, Hep A #2, and repeat smallpox vaccines 10/16/03- started to feel a burning, itching sensation on his lower left calf- noticed a large blister surrounded by multiple small blisters on his lower left calf- lesions nontender, moderately pruritic, eryematous and edematous- no c/o f/c or malaise. 10/17/03- size and number of lesions decreased- most blisters got popped and some have already crusted over- no longer c/o burning sensation- less edema, erythema, and pruritus noted- patient seen at the clinic - denied any other blisters on body or having any lesions in his mouth- h/o chronic dry skin o/w unremarkable- FH insignificant- no h/o allergies- on no meds- no recent exposure to poison ivy or Chicken pox- no field exposure- no recent h/o friction/trauma to the area- no recent new skin product use- patient in NAD- afeb 10/20/03- no c/o sx/sx of infection 10/27/03- Lesions now replaced by dry black-colored scabs- no c/o sx/sx of infection- will obtain sera for the presence of pemphigus antibody  A copy of the patient's summary mailed to VAERS via FedEx on 11/12/03				Y					Y	10/07/2003	10/16/2003	9	Pemphigus antibody- pending	MIL	MIL	None	None	Chronic dry skin			1						1	Blister; Erythema; Pruritus; Skin burning sensation; Skin ulcer; Blister; Injection site erythema; Injection site reaction; Oedema; Pruritus; Skin burning sensation; Skin ulcer	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~FAV075~2~~RA~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|HBPV~UNKNOWN MANUFACTURER~~UNK~~~HIB POLYSACCHARIDE (NO BRAND NAME)~2|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~2|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~2|SMALL~PFIZER\WYETH~FAV075~2~~RA~SMALLPOX (DRYVAX)~2|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0212261	11/12/2003	IL	44.0	44		F	11/12/2003	Extreme fatigue Bell's Palsey				Y					Y	10/27/2003	10/27/2003	0	none	UNK	PUB	none	no	none			1						1	Facial palsy; Fatigue	FLU3~SANOFI PASTEUR~U1127AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212265	11/12/2003	NV	73.0	73		F	11/12/2003	Severe chills  High Fever ( too sick to get thermometer) Muscle aches Headache Shooting pains Delerium Weak Pale Nauseous Had shot at aprox. 1:30 p.m.  At 10;00pm all these symptoms began.  By 10:00 a.m. I was back to normal. Weak									Y	11/04/2003				UNK	UNK		None	None			1						1	Asthenia; Chills; Delirium; Headache; Myalgia; Nausea; Pain; Pallor; Pyrexia	FLU3~PFIZER\WYETH~u1143AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0211968	11/13/2003	CA	61.0			M	11/10/2003	From initial information received on 07/Nov/2003 from a health care professional regarding an adverse event, it was reported that a 61-year-old male patient (birth date not reported) received a dose of FLUZONE, lot number U1078AA, on 20/Oct/2003. The route and site of administration were not reported. Eight days later, the patient developed bilateral lower extremity weakness. A nerve conduction study was compatible with the diagnosis of Guillain-Barre. Examination showed the presence of bilateral weakness and the absence of deep tendon reflexes. The pt was admitted to the hospital and given five doses of immunoglobulins intravenously. He was then transferred to a rehabilitation center. A MRI was performed, which had no abnormal findings and a lumbar puncture was negative. The patient was still recovering at the time of this report. Discharge summary states hypertension, infection urinary tract, pain in back, pherial edema; GBS not confirmed. msv					Y	7			N	10/20/2003	10/28/2003	8	Lumbar puncture - negative; MRI - no abnormal findings; Nerve conduction Study Test - consistent with Guillain-Barre. Discharge summary states .Lab test abnormal. msv	PVT	PVT		No	No Discharge summary states back pain, dyspnea, arthritis. msv		200302926	1						2	Areflexia; Guillain-Barre syndrome; Immunoglobulin therapy; Intensive care; Lumbar puncture abnormal; Muscular weakness; Nerve conduction studies abnormal; Nuclear magnetic resonance imaging normal; Back pain; Guillain-Barre syndrome; Hypertension; Hyporeflexia; Laboratory test abnormal; Muscular weakness; Oedema peripheral; Urinary tract infection	FLU3~SANOFI PASTEUR~U1078AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1078AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0212178	11/13/2003	KY	18.0	18		M		Pericarditis was considered medically important (OMIC). A mother reported that her 18 year old son received a dose of Flumist solution on 10/11/03. The pt's concurrent illnesses include an unspecified nerve disorder, allergies, and GERD. The pt also has a history of pericarditis and urinary tract problems as a result of a car accident in March 2003. Indication for Flumist was immunization. Product was administered on 10/11/03. Dose regimen was one dose. Concomitant therapy included Paxil, Detorl LA, Protonix, guaifenesin, Advair, and Clarinex. On 10/14/03, the reporter's son experienced sores in his mouth (stomatitis). The pt returned to his physician on 10/15/03 and received Valtrax to treat the mouth sores; however, it was reported the Valtrex did not help. On 10/20/03, he developed fever of 102-104 deg F and chest pain. The mother believed that her son's pericarditis (condition aggravated) might have returned as a result of receiving Flumist. Her son had not returned to his physician since experiencing the fever and chest pain. All events were unresolved at the time of this report. No additional info was available at the time of this report.  The medical records received on 11/20/03 state pharengitis.				Y					N	10/11/2003	10/14/2003	3	UNK	PVT	PVT	Advair, Detrol LA, guaiphenesin, Paxil, Protonix, Paxil, Valtrex	UNK	GERD, hypersensitivity, urinary tract disorder, pericarditis, road traffic accident, sinus dis, anxiety, depression and shoulder injury.		HQWYE380221OCT03	1						1	Chest pain; Condition aggravated; Pericarditis; Pharyngitis; Pyrexia; Stomatitis	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0212184	11/13/2003	NV	61.0	61		F	11/05/2003	Approximately 4 hours after vaccine patient became chilled, felt numbness and tingling at fingers. At 8 hours after the vaccination patient had temperature of 102. Temperature up and down all week. On 10/17 went to Internist and temperature 104. Labs and CT ordered stat. The discharge summary received on 11/21/03 states adeno carcinoma.				Y	Y	6	Y		Y	10/13/2003	10/13/2003	0	Pelvis US resulted in TAH/BSO when endo CA noted.	PVT	PVT	Motrin; ASA; Prevacid; Synthroid; Tavist	NONE	Patient diagnosed approximately 1 week post event with endomentrial CA.			1						1	Chills; Hypoaesthesia; Neoplasm malignant; Paraesthesia; Pyrexia	FLU3~EVANS VACCINES~765854~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0212187	11/13/2003	NC	1.0	1	.0	M	10/10/2003	4:35 PM localized reaction right and left deltoid injection sites, redness and welt approx 5 minutes after varicella and MMR given. Dr made aware. 4:40 PM Applied cold compresses to bilateral deltoid areas. Checked per Dr. No other adverse reaction noted. Benadryl 4ml PO given at 5 PM. Checked every 5 minutes. Redness decreased and welt resolved. Checked per Dr. Pt home with parents, may give 4 ml Benadryl PO tonight every 6 hours PRN.									Y	10/10/2003	10/10/2003	0	NONE	PVT	PUB		NONE	NONE		NC03126	1						1	Injection site erythema; Urticaria	FLU3~SANOFI PASTEUR~U1088AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UA862AA~4~IM~RL~HIB (PROHIBIT)~1|MMR~MERCK & CO. INC.~1229M~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~493476~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0558N~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0212188	11/13/2003	NC	66.0	66		F	10/31/2003	10/29/03: Pt called health dept in the AM to report right arm a little swollen and red at injection site, reported increased pain. Advised pt to hold ice to arm and take antiinflammatory, e.g. ASA, Ikotrin as tolerated and to call back or see MD PM. 10/30/03: Pt to health dept, reports increased pain, increased redness, increased swelling. This nurse noted increased redness, increased swelling and hot to touch from site of injection at right deltoid to elbow. Referred to MD. 10/31/03: Nurse phoned pt, she reports she did see doctor and was Dx'd with infection. Is taking antibiotic (Keflex) and Benadryl per doctor's order. It states she ran a fever last night of 102 degrees. She states she is feeling better today, swelling is decreased and pain decreased.				Y					U	10/28/2003	10/28/2003	0	NONE	PUB	PVT	Celebrex, Ionto-photesis; allergy shots	NONE	Arthritis; allergies: dog/cat, dust mites, grass		NC03127	1						1	Infection; Injection site erythema; Injection site oedema; Injection site warmth; Pain	FLU3~SANOFI PASTEUR~U1127AA~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1027M~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212189	11/13/2003	NC	26.0	26		F	10/24/2003	Pt states, hard knot developed at site of injection, size of large lemon. Site was red and fevered. Could barely move arm. Knot had decreased in size by time of Dr visit. Reaction occurred approx 6 hours after injection. Tx'd with med for soreness.				Y					Y	10/20/2003	10/21/2003	1		PUB	UNK	Levoxil, Rexopriosi	NONE	ASA		NC03129	1						1	Injection site erythema; Injection site mass; Injection site oedema; Injection site warmth; Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~U1089AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212190	11/13/2003	IN	4.0	4		F	11/11/2003	Multiple clusters of up to 5mm vesicular lesions on left anterior, medial and lateral thigh with a few lesions on anterior knee. Itching. c/o leg hurting since shots given 3 weeks ago, but mom just looked at skin, noted rash today. No tx given yet, I am prescribing hydroxyzine for itching and topical 1% hydrocortisone today.									U	10/20/2003	11/11/2003	22		OTH	PUB						1						1	Injection site vesicles; Pain; Pruritus; Rash; Skin ulcer	FLU3~SANOFI PASTEUR~U1088AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1171M~UNK~IM~LL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212191	11/13/2003	DE	58.0	58		M	11/01/2003	Member came into immunizations clinic on Saturday, 11/01/03 in the morning. He received 2 shots. Early in the afternoon, he began to feel lightheaded, dizzy, warm and sweaty with mild nausea. He came into the clinic and was assessed by the provider.				Y					Y	11/01/2003	11/01/2003	0		MIL	MIL	PPD Aventis C1113AA arm	NONE	Hypertension			1						1	Dizziness; Feeling hot; Hyperhidrosis; Nausea	FLU3~SANOFI PASTEUR~765754~5~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212192	11/13/2003	NM	28.0	28		F	11/12/2003	Pt woke up in AM with foot pain. 10/26/03 No known injuries. 10/29/03 pain has moved into ankle, neuroma vs cellulitis/phlebitis. 11/3/03 4th day of antibiotic, tendon ROM ligs stable. Tendon anterior tib 1/3 up pain on palp arch of foot plantar dorsal.									U	10/16/2003	10/26/2003	10	X-ray on foot/ankle, arthritis/gout panel referral, viral synovitis, further lab needed.	PVT	MIL	NONE	NONE	PCN allergy			1						1	Cellulitis; Neuroma; Pain in extremity; Phlebitis	FLU3~SANOFI PASTEUR~U1097AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212193	11/13/2003	CA	4.0	4		F	11/12/2003	10 minutes after injections, PPD left forearm, flu vaccine left deltoid, #1 Hep A right deltoid, developed red cheeks with small hives, spread to forearms and upper arms. Left worse than right.									Y	11/12/2003	11/12/2003	0	NONE	PVT	PUB		NONE	NONE			1						1	Erythema; Urticaria	FLU3~SANOFI PASTEUR~U1139AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0039N~1~~RA~HEP A (VAQTA)~1	USA		Influenza
0212194	11/13/2003	AK	80.0	80		M	10/30/2003	Pt reports no significant reaction or problem until about 3 days ago when he began experiencing difficulty raising left arm above head. Denies swelling, heat, tenderness to touch or fever.									Y	10/23/2003	10/27/2003	4		PUB	PUB	Alleve, Fosamax, Vioxx, HCTZ, APAP	NONE	Osteoarthritis			1						1	Joint range of motion decreased	FLU3~SANOFI PASTEUR~U1141AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0820AA~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0212195	11/13/2003	NJ	39.0	39		F	10/17/2003	Approx 1 hour after vaccine pt developed foggy vision, numbness/tingling mouth and lips, facial flushing, neck and head ached.									Y	10/16/2003	10/16/2003	0		PVT	UNK	Dilantin	NONE	Lyme disease 6/03, seizure disorder			1						1	Flushing; Headache; Hypoaesthesia; Paraesthesia; Vision blurred	FLU3~SANOFI PASTEUR~U1137CA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212196	11/13/2003	NY	43.0	43		F	11/06/2003	6 x 3cm cellulitis at site of administration warm to touch.									Y	11/03/2003	11/04/2003	1		PUB	PVT	Avapro, Triamterene					1						1	Cellulitis; Feeling hot	FLU3~EVANS VACCINES~765875~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212197	11/13/2003	WA	64.0	64		F	11/07/2003	Bilateral, high-pitched tinnitus beginning approx 2 weeks after flu vaccine. Has now had symptoms for 10 days. Otherwise well and no other identified etiology.									N	10/17/2003	10/30/2003	13		PVT	UNK	Multivitamins (no changes)	NONE	NONE			1						1	Tinnitus	FLU3~EVANS VACCINES~765670~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212198	11/13/2003	OH	55.0	55		M	11/07/2003	States had flu vaccine 10/6/03 at vocational school during public clinic, states developed pain right arm and hand shortly after, few hours, seen per MD, put on antibiotics. On Celebrex at present. C/o continued pain, not feel ROM, reported to agency on 11/05/03. No redness or edema RD.									U	10/16/2003	10/16/2003	0		PUB	PVT		NONE				1						1	Pain	FLU3~SANOFI PASTEUR~U1088AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212199	11/13/2003	MI	4.0	4		F	11/04/2003	Came to office 10/30/03 AM. Left upper arm very red measuring 8 cm x 9 cm., hot to touch, swollen. Put on Zyrtec tsp per day and Keflex susp 1 tsp tid for 1 week. 10/31/03 Pt brought in, site started blistering all over last night, was still very red. According to mom much better this AM. Rx for Prelone syrup given.				Y					Y	10/28/2003	10/29/2003	1		PVT	PVT	NONE	NONE				1						1	Blister; Injection site erythema; Injection site oedema; Injection site warmth	DTAP~SANOFI PASTEUR~C1707AA~5~~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1089AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X0148~4~~LA~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0133N~2~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0212200	11/13/2003	CA	4.0	4		M	11/05/2003	Swelling and erythema of left upper arm.									Y	11/03/2003	11/04/2003	1	NONE	PVT	UNK		URI	NONE			1						1	Injection site erythema; Injection site oedema	DTAP~GLAXOSMITHKLINE BIOLOGICALS~592A9~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1134BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212201	11/13/2003	MN	51.0	51		F	11/06/2003	Very serious headache - lasted 5 days.									Y	10/23/2003	10/23/2003	0		PVT	PVT	NONE	NONE	NONE			1						1	Headache	FLU3~SANOFI PASTEUR~U1144AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212202	11/13/2003	FL	65.0	65		F	11/06/2003	Received shot approximately at 3:30 PM. At around 9:00 PM the same day developed hives to bil forearms and then to bil upper thighs progressing to waist and trunk. Did not have welts or respiratory symptoms. Eyelids swollen next morning. Went to see a nurse practitioner next day and then to a dermatologist. Prescribed Prednisone for 17 days.				Y					Y	11/05/2003	11/05/2003	0		PUB	OTH	Cozar, Elavil, Premarin, Actos, Pulmacort, Clarinex, HCTZ, KCl	Cold	Asthma, eczema, hypertension			1						1	Eyelid oedema; Urticaria	FLU3~SANOFI PASTEUR~U1141AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212203	11/13/2003	OR	65.0	65		M	10/29/2003	Approximately 5 hours after receiving flu shot, I came down with fever and body aches. The next day still had same problem with heavy drainage, weakness and headaches and plugs sinus. These symptoms have continued for over 7 days with slow recovery since also during this period, stomach uneasy and loose bowel.									N	10/14/2003	10/14/2003	0		PVT	OTH	Advair	Emphysema	Emphysema			1						1	Diarrhoea; Headache; Pain; Pyrexia; Sinus congestion; Stomach discomfort	FLU3~EVANS VACCINES~765670~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212204	11/13/2003	IN	36.0	36		M	10/31/2003	2 days after shot, started with sore throat, coughing, chest pain (from coughing), fever, congestion, runny nose that continued for just over one week. Taking antibiotics.									U	10/22/2003	10/24/2003	2		OTH	UNK			NONE			1						1	Chest pain; Cough; Nasal congestion; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1135FA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212205	11/13/2003	GA	40.0	40		F	11/01/2003	Pt felt dizzy/shaky after receiving vaccine and sat down. She fainted approximately 3 minutes after receiving vaccine. She was unconscious for 1-2 minutes. Ammonia inhalant was used to regain consciousness. Paramedics arrived within 10 minutes. While waiting for paramedics, I used ammonia inhalant 2-3 times because she looked as if she might faint again. She had the urge to vomit, but did not vomit. When paramedics arrived her pulse was fine, and pt was alert. Her blood pressure was low but that is normal for the pt. Her blood sugar reading was 102. Pt was fine at 8:00 that night when I called to check on her and again she was fine on Saturday, November 1.									Y	10/31/2003	10/31/2003	0	Normal pulse, blood pressure and blood sugar	OTH	PVT	Claritin, Imitrex	NONE	Penicillin allergy; migraine			1						1	Dizziness; Loss of consciousness; Syncope; Tremor	FLU3~SANOFI PASTEUR~U1076AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212208	11/13/2003	PA	69.0	69		F	11/06/2003	Started with light-headedness within 1 hour, decreased tiredness next day, above continued, plus got headache (severe) by 3rd day, blood pressure and pulse became elevated.  Rash started on arms and chest, headache severe, paleness 4th day-red, blotchy rash all over (except legs) and blood pressure and pulse continued to increase and low fever (on and off).				Y					U	10/28/2003	10/28/2003	0	NONE	OTH	OTH	Lopressor; Altace; Lanoxin; ASP; Xanax; Kour; Lasix; Zucor; Tanoxifen	NONE	Heart Disease; Supra ventricular tachycardia; Mitral Valve Prolapse; Hypertension; Multi drug allergies			1						1	Blood pressure increased; Dizziness; Erythema; Fatigue; Headache; Pyrexia; Rash; Rash macular	FLU3~SANOFI PASTEUR~U1133AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212209	11/13/2003	LA	70.0	70		F	11/06/2003	Approximately 8 cm erythema in area of injection.  Getting better at the time she came in to let MD check it.  Diagnosis per MD: local reaction to Pneumovax.  Patient to monitor and come back if size increases or gets fever.				Y					Y	11/03/2003	11/03/2003	0	NONE	PVT	PVT	Celebrex; Premarin (07/03)	NONE	Codeine			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U1139AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1079M~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212210	11/13/2003	ME	76.0	75		F	11/06/2003	8 days after injection's, patient complained of nausea, vomiting, diarrhea (also had med changes during that time).  No fever.									Y	10/20/2003	10/28/2003	8	Labs Pending	PVT	OTH	Lipitor; Dyazide; Metformin	NONE	NONE			1						1	Diarrhoea; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U1138AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0256N~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212212	11/13/2003	NJ	80.0	80		F	10/31/2003	Approximately 30 hours after vaccination, patient developed rash over her entire body.				Y					U	10/20/2003	10/21/2003	1	NONE	PUB	PUB	Prilisec; Fosamax	NONE	Gastroesophageal reflux Disease and requires medication for bone density.			1						1	Rash	FLU3~SANOFI PASTEUR~U1137HA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212213	11/13/2003	MS	8.0	8		M	11/05/2003	Patient had an onset of 103 fever just a couple of hours after the vaccine.  His fever lasted 5 days an arm swelling up with soreness for over 2 weeks.  His speech became slurred and lasted over 30 days.  He is still having problems concentrating/body aches. MD will not have patient vaccine again.				Y					N	10/01/2003	10/01/2003	0	Urine 24 hour catch; Mercury test after 30 days because lab lost first specimen for test had to redo test.	PVT	PUB	Prevacid for reflux; Albuterol; Ritalin; Claritin; Singulair; Carafete	NONE	Allergic reaction to Pertussis vaccine/Mercury; Asthma; ASHB; Barretts Esophagas	1996-report on file at VAERS~DTaP (no brand name)~~1.00~In Patient		1						1	Disturbance in attention; Injection site oedema; Injection site pain; Pain; Pyrexia; Speech disorder	FLU3~EVANS VACCINES~765670~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0865N~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212214	11/13/2003	CA	1.6	1	.5	F	11/05/2003	Mom noticed swelling and redness tuesday evening at bath time.  Redness and swelling-half inch above injection site to half way to elbow.  3-4 fingers in width.  Tender to touch.  Feels hot/warm to touch.  Fever up to 101.  Has been using Tylenol.  Recommended Motrin.  Call back as needed.									U	11/03/2003	11/04/2003	1	NONE	PVT	PVT	NONE	Runny nose	Posterior descending (coronary) artery surgery 11/02; Atrial Septal Defect			1						1	Injection site erythema; Injection site oedema; Injection site warmth; Pyrexia; Tenderness	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~21885C9~4~IM~RA~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1099AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212215	11/13/2003	MN	38.0	38		F	11/04/2003	Rash on body-resembling hives									Y	10/30/2003	11/01/2003	2	NONE	OTH	PVT	NONE	NONE	Aspirin, Sulfa, Percocet, Z-pack			1						1	Rash	FLU3~SANOFI PASTEUR~U1146BA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212216	11/13/2003	NV	38.0	38		M	11/03/2003	Welts 2 at injection site, edemetous, red, hot to touch x 24 hours.									Y	10/30/2003	11/01/2003	2	NONE	MIL	OTH	NONE	NONE	Hepatitis C; Hydrocele			1						1	Erythema; Injection site warmth; Oedema; Urticaria	FLU3~SANOFI PASTEUR~U1093AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0604N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212217	11/13/2003	CA	23.0	23		F	11/05/2003	Progressive numbness from eyelid to nose to face to entire body, beginning 3 days after vaccination.									U	10/29/2003	11/01/2003	3	NONE	PVT	PVT	Viracept; Combivir; Tegretol; Acyclovir;	NONE	Sulfa, Codeine allergies; HIV positive; Seizure disorder			1						1	Hypoaesthesia	FLU3~SANOFI PASTEUR~U1078AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212218	11/13/2003	NJ	77.0	77		M	11/04/2003	Received vaccine shot at 10:30, and by 14:00 was feeling sick-with fever, chills, headache, symptoms lasted several days.  No appetite for several days-lost weight.				Y					Y	10/28/2003	10/28/2003	0	NONE	PUB	OTH	Insulin; Propranolol 10mg; Digiteck 250mg;	NONE	NONE			1						1	Anorexia; Headache; Pyrexia; Weight decreased	FLU3~SANOFI PASTEUR~U1146DA~7+~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212219	11/13/2003	CA	64.0	64		F	11/03/2003	Allergic Reaction, went to ER.  Arm swollen, hot				Y					Y	10/22/2003	10/23/2003	1	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Hypersensitivity; Injection site oedema; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0212220	11/13/2003	PA	35.0	35		M	11/05/2003	Blotch on chin-ecchymalis 17mmx3mm.  Denies any trauma.  Violaceous 16:00 (11/04/2003), No respiratory distress, S1 S2 (-), M-B.  Temperature 98.1-98.7.  Blood pressure: 124/80, Pulse: 80; Respiratory: 16;									Y	11/05/2003	11/05/2003	0	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Ecchymosis; Rash macular	FLU3~SANOFI PASTEUR~U1141AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212221	11/13/2003	TX	28.0	28		F	10/30/2003	Onset evening of flu shot-redness and swelling to site, tender.  No abscess, no fever, no streaking, no respiratory or other problems.  Treatment: Local heat, advil. Unable to contact person @ home.  Left messages.				Y					U	10/14/2003	10/14/2003	0	NONE	PVT	PVT	Maxair, Advair, BCP	NONE	SULFA			1						1	Injection site erythema; Injection site oedema; Tenderness	FLU3~SANOFI PASTEUR~U1094AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212222	11/13/2003	TX	3.0	4		M	11/03/2003	3x3cm redness, no streaks, tender with palpation to right lateral thigh.  Reaction 24 hours post injection. Parent noticed about 19:30.  Treatment: Benadryl, Tylenol.				Y					Y	11/02/2003	11/03/2003	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Tenderness	FLU3~SANOFI PASTEUR~U1128AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212223	11/13/2003	TX	48.0	48		F	11/03/2003	I had the flu shot on Monday 10/20/2003, after that I had a low grade fever with muscle ache, running nose, coughing for 2 weeks.  (I have had flu shot every year for more than 10 years, but I have never felt sick for so long like this before).									U	10/20/2003	10/21/2003	1	NONE	PVT	PVT	NONE	NONE	Latex allergy			1						1	Cough; Myalgia; Pyrexia; Rhinorrhoea	FLU3~EVANS VACCINES~765795~7+~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212224	11/13/2003	NM	67.0	67		F	11/04/2003	Pneumovaccine give 10/28/2003 on 10/29/2003, site red, swelling, warm to touch,painful.  Saw MD 11/03/2003.  Prescribed Atarax.				Y					Y	10/28/2003	10/29/2003	1	NONE	PVT	PVT	Lipitor 10mg; Amdizem CD 120mg; Zoloft 50mg;	NONE	NONE			1						1	Feeling hot; Injection site erythema; Injection site oedema; Pain	FLU3~EVANS VACCINES~765852~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0564N~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212225	11/13/2003	NV	51.0	51		F	11/05/2003	Approximately 12 hours after vaccination, patient complained of chills, diaphoresis, and was shaking.  Symptoms continued at least 24 hours. Before patient took temp (oral) 103.4.  Medical attention sough 10/23 Theraflu and Tylenol prescribed.				Y					Y	10/21/2003	10/21/2003	0	NONE	PVT	PVT	Zocor, Niaspan, vivelle, OTC MV, Wellbutrin	NONE	NONE			1						1	Hyperhidrosis; Pyrexia; Tremor	FLU3~EVANS VACCINES~765854~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212226	11/13/2003	OR	7.0	7		F	10/21/2003	Generalized hives lasting one days, started 18 hrs post vaccine.									Y	10/15/2003	10/16/2003	1		PVT	UNK		NONE	NONE			1						1	Urticaria	FLU3~EVANS VACCINES~765670~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212267	11/13/2003	TN	71.0	71		F	11/13/2003	13:20 received IM injection of fluzone. 13:25 pt told husband she was going to pass out. 13:30 pt not responsive to sternal rub to floor legs in air, pt then responded. A and O x3, pt flushed. 13:35 pt sitting up, nausea noted. 13:37 transferred to stretcher, BP 156/90. 14:00 pt sitting up. 14:04 DC'd ambulatory. Refused wheelchair. Instructed to call PCP.									Y	10/20/2003	10/20/2003	0		PUB	UNK			Allergic to latex			1						1	Dizziness; Nausea	FLU3~SANOFI PASTEUR~U1095AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212268	11/13/2003	TN	75.0	75		F	11/13/2003	Approx 15 minutes after injection husband stated he couldn't wake his wife up. Pt not verbally responsive. Skin cold/clammy. Pupils dilated. BP 80/50 Epi .3cc given. Pt vomited approx 1500cc coffee-ground emesis. Pt placed on stretcher cool cloth to head. BP 90/70 pulse 88. Pupils returned to normal. Pt verbally responsive. EMS present 11:30.				Y					Y	11/04/2003	11/04/2003	0		PUB	UNK						1						1	Cold sweat; Coma; Depressed level of consciousness; Mydriasis; Vomiting; Blood pressure decreased; Cold sweat; Coma; Depressed level of consciousness; Mydriasis; Vomiting	FLU3~SANOFI PASTEUR~U1253AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1253AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0212271	11/13/2003	OH	35.0	35		M	11/13/2003	Approx. 5 hours after vaccination, developed swelling around eyes & earlobes, eyes irritated. To quick care facility, given x2 injections. Next am, hives around waistline, itching, nose swelled. Went to local MD, given x2 injections & Predisone and Allegra Rx's.				Y					Y	11/04/2003	11/04/2003	0		UNK	PUB	n/a	no	no			1						1	Eye irritation; Eye oedema; Nasal oedema; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1098AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212273	11/13/2003	NY	28.0	28		M	11/13/2003	Generalized Vaccinia, lessions on back- abdomen, arm, head, and bridge of nose/eye lid, and testicle.  Lessions occured 8 days post vaccination and sm reported to health clinic at day 10. Reportsfatigue, malaise, dizziness. Sleeping 18 hours per day, feeling feverish.  Lessions itch but are generally painless.  First lession scabbed rapidly, new lessions are red on arm and bridge of nose/eyelid.  Exam done in clinic, given consult to optometry where an eye exam was conducted. Was directed to his quarters, where his roomate (seperate sleeping arrangements) is prior vaccinated. Was instructed to care for each site the same as his original smallpox site. Given 21 days quarters, and a follow up appointment tomorrow.				Y					N	11/03/2003	11/11/2003	8		MIL	MIL	Motrin	None	None			1						1	Cow pox; Dizziness; Fatigue; Malaise; Pyrexia; Somnolence	ANTH~EMERGENT BIOSOLUTIONS~fav078~3~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~765754~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~0464n~2~IM~RA~HEP A (HAVRIX)~1|SMALL~PFIZER\WYETH~4020071~1~ID~LA~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0212275	11/13/2003	TN	14.0	14		F	11/13/2003	Local erythema and swelling at injection site 2 hours after administration; swelling of lips, gums, and around eyes at 4-6 hours; facial swelling with left arm and hand (shot given in left deltoid) after 12 hours; maximal facial and lip swelling occurred at approximately 24 hours; patient did not have difficulty breathing.  She took alleve x 1 the morning after injection, as well as 2 mornings after injection.  She took benadryl x 1 24 hours after symptoms began.  Symptoms were largely resolved by the time she was seen by a physician approximtely 36-40 hours after reaction began.  No further treatment was given.  No emergency room visit occurred.									Y	11/11/2003	11/11/2003	0	None.	PVT	UNK	Kelfex, Allegra, rhniocort, ibuprofen, MVI	None.	History of knee pain with effusion, patellofemoral syndrome, anxiety disorder/depression, allergic rhinitis			1						1	Eye oedema; Face oedema; Injection site erythema; Injection site swelling; Oedema peripheral	FLU3~SANOFI PASTEUR~U1077AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~UNKNOWN MANUFACTURER~1208M~3~IM~RA~HEP B (NO BRAND NAME)~1	USA		Influenza
0212306	11/13/2003	CO	41.0	41		F	11/13/2003	Thurs. Nov 6, 2003 Received Influenza vaccine for the first time.  Monday, Nov. 10, 2003 client started noticing Headache, stuffiness in nasal passage, then runny nose, cough at first was a dry cough, progressed to slightly productive. That same evening she began itching.  First her face and scalp, then her left thigh.  She described bumps on her forehead and chin that look similar to bug bites - white in the center and red surrounding.  These bumps come and go as does the itchiness at various sites.									N	11/06/2003	11/10/2003	4	None - so far.	UNK	PUB	Advair - inhaler (borderline Asthma)	None	Seasonal allergies			1						1	Cough; Erythema; Headache; Nasal congestion; Pruritus; Rhinorrhoea	FLU3~SANOFI PASTEUR~U113AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212310	11/13/2003	MO	51.0	51		F	11/10/2003	Flu like symptoms with aches and chills.  Mouth broke out (roof of mouth) with a rash, tender.  Also rash on left breast and both buttocks.  Throat became irritated and scratchy.  Stroke like effects to both eyes with rainbow effect for 45 minutes.									Y	11/07/2003	11/09/2003	2	none	PUB	UNK			Allergy to PCN and sulfa		MO200395	1						1	Cerebrovascular accident; Chills; Influenza like illness; Pain; Pharyngolaryngeal pain; Rash; Tenderness	FLU3~SANOFI PASTEUR~766049~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212312	11/13/2003	AZ	28.0	28		M	11/13/2003	approximately 9 hours from time of injection patient presented back to ER with signs and symptoms of angioedema.				Y					Y	10/28/2003	10/29/2003	1		PVT	UNK		No				1						1	Angioneurotic oedema	FLU3~EVANS VACCINES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212315	11/13/2003	TN	69.0	69		M	11/13/2003	Started feeling unwell the evening of the day of the shot. Continued to get worse with congestation, cough and very tired.  At first the cough was dry and couldn't cough up congestation. After a day it loosened up.									N	11/05/2003	11/05/2003	0		UNK	UNK		none				1						1	Cough; Fatigue; Malaise; Nasal congestion	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212277	11/14/2003	NC	44.0	43		F	10/01/2004	It was reported that a 43 year old female pt received Fluzone on 10/23/03. An unspecified amount of time later, the pt developed a fever of 104 deg F and was taken by ambulance to the hospital. She was diagnosed with Stevens-Johnson syndrome. The pt died on 11/3/03. The reporter stated that the death certificate lists the cause of death as toxic epidermal necrolysis and severe respiratory failure. No other info was reported. A telephone call was placed to the reporter on 11/7/03, to request copies of the death certificate and autopsy report if available and any additional info. Later that day, the reporter provided the lot number info. The product was administered IM in the left deltoid on 10/22/03. The pt was admitted to the hospital on 10/25/03. The primary physician's info and vaccine supplier were also provided. On 11/7/03, during telephone contact with the primary physician, it was reported that the pt was on several other medications at the time of vaccination, including amoxicillin and two new neurological medications. He could not provide any additional info at this time. Follow up on 11/17/2003: From additional information received on 11/10/2003 from the initial reporter, it was reported that the patient died at a university medical center on 11/03/2003 at 8:38AM.  A copy of the death certificate was provided and the causes of death are listed as toxic epidermal necrolysis and Stevens-Johnson Syndrome.  The approximate interval between the onset of symptoms and death was noted to be one week.  No autopsy was performed.  The vaccine administrator and responsible physician's information were also provided, as well as the attending physician's name and contanct information from the hospital where the patient was treated.  The patient received the influenza vaccine on 10/22/2003 in the left deltoid.  E-mail correspondence with the attending physician at the hospital that same day stated that he felt that the physicians who were part of the original attending team admitting the patient to the hospital would best be able to answer requests for additional information.  He provided the names of the doctors and stated that the forwarded the request from AP, Inc. to these same physicians.  No other information was provided.  Follow up on 05/18/04 states: Despite several attempts to obtain follow up information, no additional information was provided. This case is considered closed.	Y	11/03/2003			Y	9			N	10/22/2003			No autopsy was performed.	UNK	UNK	Amoxicillin, two neurological medications		The patient was a teacher and received the vaccine at her school.  At the time of vaccination, the patient was reportedly taking amoxicillin and two new neurological medications however, the indications for each were not specified.		200302904	1						1	Respiratory failure; Stevens-Johnson syndrome; Toxic epidermal necrolysis	FLU3~SANOFI PASTEUR~U1123AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0212284	11/14/2003	CA	50.0	50		F	11/05/2003	2-4 hrs after vaccine administration, the pt developed gradually worsening chest pain and dyspnea. Eventually admitted and dx with non-malignant, large, bloody pericardial effusion. Discharge summary states abdominal pain, anemia. msv			Y	Y	Y	3			Y	09/23/2003	09/23/2003	0	Pericardial centesis; Echo; Liver enzymes elevated.	PVT	PVT	Estradol, Maxaimdi, Allegra, Imipramine	Headache	Migraine, asthma, ADHD, allergic rhinitis, gen. anxiety Discharge summary states cardiovascular disease. msv Medical records state.hypertension. msv			1						1	Abdominal pain; Anaemia; Chest pain; Dyspnoea; Hepatic enzyme abnormal; Pericardial effusion	FLU3~SANOFI PASTEUR~U1253AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0212287	11/14/2003	SC	65.0	65		F	11/05/2003	Vaccination 11/4/03, injection at 10 AM, redness and itching at 6 PM, no rash. 11/5/03 a red streak had appeared where pneumonia shot was given, downward and backward under my arm. It is warm to touch and pain (mild). No swelling, no fever, no N/V, no other symptoms. No Tx used.									Y	11/04/2003	11/04/2003	0		PUB	UNK	Maxzide, Ziac, Bestra, Evista, Zoloft	NONE	Hypertension			1						1	Feeling hot; Injection site erythema; Pain; Skin striae	FLU3~SANOFI PASTEUR~U1260AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0445M~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212288	11/14/2003	FL	66.0	66		F	10/30/2003	Approximately hours after vaccine administered, deltoid area left arm began to become painful, swollen, and warm to touch. Patient applied ice and took Motrin. She repeated this and around 15 hours post immunization, area began to be less painful. THe discharge summary received on 3/3/04 states cellulitis and allergic reaction.					Y	3			Y	10/29/2003	10/30/2003	1		PUB	PUB		NONE	Sulfa; Morphine; Codeine; Tetracycline; hypertension; hyperlipidemia; hypothyroid			1						1	Cellulitis; Injection site pain; Injection site swelling; Injection site warmth; Erythema; Feeling hot; Pain; Swelling	FLU3~SANOFI PASTEUR~075AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0873M~2~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~075aa~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0873m~2~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0212289	11/14/2003	VA	70.0	70		F	11/06/2003	Starting hurting, couldn't move it, so sore. Left arm 100mm wide, 75mm long, redness 35mm, cellulitis. Has asthma and allergies, emphysema. Takes a lot of meds.									Y	11/06/2003	11/06/2003	0		PUB	PUB	Asthma, allergy, sinuses	NONE	Allergies to penicillin, denied allergies to eggs, chicken			1						1	Cellulitis; Injection site erythema; Joint range of motion decreased; Pain	FLU3~EVANS VACCINES~765878~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0864N~2~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212290	11/14/2003	NY	31.0	31		F	11/10/2003	Had shot 11/7/03. 11/08/03 AM noted itching, swelling, redness at injection site LUE. Seen by nurse 11/10/03. No induration noted, redness at site measures 6 cm, area warm to touch, itching, redness reported.									Y	11/07/2003	11/08/2003	1		OTH	PVT	NONE	NONE	Chronic sinus infection			1						1	Feeling hot; Injection site erythema; Injection site oedema; Pruritus	FLU3~EVANS VACCINES~765753~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212291	11/14/2003	NY	56.0	56		F	11/07/2003	Tingling sensation started in lower legs, moved up through body to arms and head, lips. Tongue felt swollen. Radial pulse rapid 100. BP 94/70. Benadryl liquid 4 tsps po with relief in 10 minutes.									Y	11/06/2003	11/06/2003	0		PUB	PUB	Prempro	NONE	Penicillin			1						1	Heart rate increased; Paraesthesia; Tongue oedema	FLU3~EVANS VACCINES~765797~4~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212292	11/14/2003	AZ	69.0	69		F		Top of left arm swollen very tight from shoulder to elbow and broke out with a rash, almost looked like blisters (but was not). That night I was very ill. Took 5 or 6 days for arm to be back to normal.									Y	10/31/2003				OTH	UNK		NONE				1						1	Injection site oedema; Malaise; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0212293	11/14/2003	CA	5.0	5		F	11/07/2003	Local rx 3x4 inch red raised area with pain and malaise.									Y	11/06/2003	11/07/2003	1	NONE	PVT	PVT	NONE	Allergic rhinitis, Eczema	Sulfa allergy			1						1	Injection site pain; Malaise; Rash erythematous	FLU3~EVANS VACCINES~765178~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212294	11/14/2003	IL	57.0	57		M	11/06/2003	Severe chills and shaking for 5 hours.  Did not take temperature.  After 23:00 had sweating all night.  Next day has about 1/3 energy, body aches, stuffy nose, sore throat.  On 11/04/2003 started taking Zinc tablets and Claritin 10mg daily as needed.  Started both in evening.  Did not contact doctor or hospital.  Told nurse on 11/06/2003.									N	11/03/2003	11/03/2003	0	NONE	OTH	PVT	Zinc tablet prn; Claritin prn	NONE	NONE	No energy~Influenza (Seasonal) (no brand name)~1~48.00~In Patient		1						1	Asthenia; Chills; Hyperhidrosis; Nasal congestion; Pain; Pharyngolaryngeal pain; Tremor	FLU3~SANOFI PASTEUR~U1126AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212295	11/14/2003	CT	46.0	46		F		Localized erythema to injection site.  Suspect cellulitis.  Prescribed Keflex 800mg 1 pill three times a day for 10 days.				Y					U	11/06/2003	11/06/2003	0	NONE	OTH	PVT	Celexa	NONE	PCN allergy			1						1	Cellulitis; Injection site erythema	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0212296	11/14/2003	CA	79.0	78		F	11/07/2003	Lost strength and control of right hands and arm for several seconds.  Then it cleared up and I was ok.  Thought I was having a stroke so I coughed really hard several times.									Y	11/03/2003	11/03/2003	0	NONE	PUB	OTH	NONE	NONE	NONE			1						1	Asthenia; Hypokinesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212297	11/14/2003	OH	43.0	43		F	11/07/2003	Patient felt hot, flushed then lightheaded.  Patient was made to lie down with feet elevated.  Patient never lost consciousness.  Patient's pulse was fine.  All symptoms resolved within 15-20 minutes.									Y	11/05/2003	11/05/2003	0	NONE	PUB	PVT	NONE	Multiple Sclerosis	Penicillin, Macrodantin, Sulfonamides			1						1	Dizziness; Hot flush	FLU3~SANOFI PASTEUR~U1088AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212299	11/14/2003	IL	68.0	68		M	11/06/2003	Red, itchy rash/hives appeared buttocks and thigh areas.  Applied Caldyphen and reaction was relieved and disapeared only to recur to a lesser degree.  Same situation thru this writing.									U	10/30/2003	10/30/2003	0	NONE	OTH	OTH	High Blood Pressure, Daily pill Anthenol	NONE	Hypertension			1						1	Hypertension; Injection site erythema; Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212300	11/14/2003	UT	27.0			F	10/31/2003	Received flu in left arm.  Swollen glands in armpit, into breast in bicep area as well.  2 days ago received.									U				NONE	PUB	OTH	Imiran; Methadone; Asacol; Lortab	NONE	Chrones			1						1	Lymphadenopathy	FLU3~EVANS VACCINES~765874~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212301	11/14/2003	VA	54.0	54		F	11/04/2003	Broke out with a rash.  Started Friday on arms, chest.  Sat now spread to her neck, thighs.  Sat 11/01, called clinic for appointment, schedule at 11/02/2003 @ 13:00.  Told to use Benadryl and Oatmeal bath.  MD appointment received Hydroxygen-PC 25mg Tab/Medrol Dose Pack 4mg.				Y					Y	10/29/2003	10/31/2003	2	NONE	PUB	OTH	NONE	NONE	NONE			1						1	Rash	FLU3~SANOFI PASTEUR~U1089AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212302	11/14/2003	MA	58.0	58		F	10/20/2003	Awoke on 10/15/2003 with headache and much lower abdominal gas.  Rested the day, approximately 19:00 felt achy without low grade temp.  Awoke Thursday 10/16/2003 with headache gone, fever droke around noon.  MD was notified.  Patient was happy with my concern.									Y	10/13/2003	10/15/2003	2	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Flatulence; Headache; Pain; Pyrexia	FLU3~EVANS VACCINES~765485~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212303	11/14/2003	WI	79.0	79		F	11/06/2003	Severe redness entire left arm and much of left chest, general tiredness and some faintness occurred.  Rash lasted about 10 days weariness lasted 7-10 days.  Improving.									Y	10/23/2003	10/25/2003	2	NONE	PVT	PVT	NONE	NONE	COCAINE			1						1	Dizziness; Erythema; Fatigue; Rash	FLU3~EVANS VACCINES~765876~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212304	11/14/2003	TX	75.0	75		F	11/13/2003	Patient states developing large dark spots on skin, around back of neck, chest, arms and inner thighs about 2 days after receiving vaccines.  Patient presented with doctor with darkening of skin, peeling.  Patient states affected areas are itchy.  Aristocrest cream, Atarax 25mg, someration solution prescribed.  Patient is to return 1-2 weeks.				Y					U	10/02/2003	10/04/2003	2	NONE	PUB	PUB	Norvasc, Furosemide, ASA, Lisidrol	NONE	Hypertension, Coronary Artery Disease, Diabetes Mellitus Type 2, Diabetec Nepropathy			1						1	Pruritus; Rash maculo-papular; Skin discolouration; Skin exfoliation	FLU3~SANOFI PASTEUR~U1074AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0828AA~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0212305	11/14/2003	CA	31.0	34		F	11/07/2003	50mmx30mm red, painful area on left upper arm at injection site.									U	11/04/2003	11/06/2003	2	NONE	PUB	OTH	PPD (AP) (Lot # C1262AA) (Left forearm/ID); Lipitor, ASA	NONE	Hyperlipidemia			1						1	Injection site erythema; Injection site pain	FLU3~EVANS VACCINES~765165~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TTOX~SANOFI PASTEUR~U1011AA~1~IM~RA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0212316	11/14/2003	NY	49.0	49		M	11/13/2003	Patient developed Bell's Palsy left.  3 days after influenza vaccine was given. Follow up on 11/17/2003: Eye tearing, can close eyes-facial droop on Prednisone.  Follow up in office in 2 weeks.				Y					N	11/06/2003	11/10/2003	4	NONE	PVT	PVT	Atenolol 100mg; Plendielo; Diovan; HCT 225; Cataprid;	NONE	Hypertension			1						1	Facial palsy; Lacrimation increased	FLU3~SANOFI PASTEUR~U1068AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212317	11/14/2003	CO	57.0	56		F	11/13/2003	Redness with inflammation at injection site that became the size of a fist.  Patient used ice packs and Motrin.									Y	10/21/2003	10/21/2003	0	NONE	PVT	PVT	Synthroid; Albuterol	NONE	Flagyl; Vicodin			1						1	Injection site erythema; Injection site inflammation	FLU3~SANOFI PASTEUR~U1069AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1027M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212318	11/14/2003	MI	24.0	24		M	11/13/2003	Mother called office next day.  Approximately 1-1.5 hours after immunization given, raised rash on neck, back, flank, thighs.  Nothing noted at immunization sites.  Mother gave Benadryl with rash vanishing later in evening and no recurrence.									Y	11/10/2003	11/10/2003	0	NONE	PVT	OTH	Fiber Pill	NONE	Autism, Hyperlipidemia			1						1	Rash erythematous	FLU3~SANOFI PASTEUR~U1255AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0981M~2~IM~LA~HEP A (VAQTA)~1	USA		Influenza
0212319	11/14/2003	NY	33.0	33		M	11/13/2003	2 hours after flu shot, complained of feeling weak, flushed, thick tongue.  Blood pressure: 112/80; Pulse: 60; diffuse erythematous maculopapular rash arms, chest, back.  Non pruritic.									U	11/13/2003	11/13/2003	0	NONE	PUB	PUB	Lipitor 10mg	NONE	High Cholesterol			1						1	Asthenia; Erythema; Flushing; Rash macular; Rash papular; Tongue disorder	FLU3~SANOFI PASTEUR~U1126AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212320	11/14/2003	IL	47.0	46		F	11/13/2003	About 20 minutes after injection, noticed scratchy throat.  Approximately 40 minutes after, severe itching to arm, tightening of throat, hives in mouth.  Benadryl 1cc IM given.  Relief within 15 minutes. The follow up received on 12/23/03 states adverse event onset date was 11/19/03 that evening.									Y	10/24/2003	11/19/2003	26	1cc Benadryl IM given per standing orders	OTH	PUB	Allegra; Synthroid; Lipitor	NONE	Thyroid; Allergies			1						1	Dry throat; Pruritus; Throat tightness; Urticaria	FLU3~EVANS VACCINES~765854~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212321	11/14/2003	IL	57.0	57		U		Day after vaccination, pneumonia injection site, very sore developed red line around site to post chest call.  Stated it even hurt to lift up my arm.									Y	11/03/2003	11/04/2003	1	NONE	OTH	PUB	NONE	NONE	NONE			1						1	Cellulitis; Hypokinesia; Pain	FLU3~EVANS VACCINES~765876~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0358M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212322	11/14/2003	CA	6.0	6		M	11/12/2003	1 day after flu shot administered to right thigh, developed redness, progressing with pain, tenderness, warmth consistent with cellulitis.  Treated with Keflex.									Y	11/10/2003	11/11/2003	1	NONE	PVT	PVT	NONE	Thigh cellulitis	NONE			1						1	Cellulitis; Feeling hot; Injection site erythema; Injection site pain; Tenderness	FLU3~SANOFI PASTEUR~U10927AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212341	11/14/2003	MI	69.0	69		M	11/14/2003	Patient was admitted with bleeding into colsotomy bag after taking influenza shot 7 days earlier.He was admitted to ICU where he received FFP and blood transfusions.			Y	Y	Y	5			Y	11/04/2003	11/11/2003	7	Patients INR on admission was 219 and hemoglobin was 9 gm.	PVT	PVT	Coumadin	None	Atrial fibrillation, HTN, CVA, DM			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U1089AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0212342	11/14/2003		21.0			M	11/14/2003	Patient reports hives appearing 4 hours after vaccine.  Went to sleep and 12 hours later awoke short of breath, diffuse hives, and throat tightness.  Taken to ER and treated with epinephrine, benadryl, and prednisone				Y					Y	10/31/2003	10/31/2003	0	None	MIL	MIL	Manufacturer is Powerject Pharm	None	None -- however was taking minocin at same time of reaction but has continued to take it daily since the reaction as well without problems			1						1	Dyspnoea; Throat tightness; Urticaria	FLUX~UNKNOWN MANUFACTURER~765141~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0212344	11/14/2003	OH	40.0	40		F	11/14/2003	Lump at site of vaccine 24 hours after receiving and a smaller lump behind the site.									U	11/10/2003				PUB	PUB	None	None	None			1						1	Injection site mass	FLU3~SANOFI PASTEUR~U1270AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212345	11/14/2003	TX	40.0	41		F	11/14/2003	Temperature of 103F for three days - ongoing Aches/sweating/Shivers				Y					U	11/11/2003	11/11/2003	0		UNK	PVT		none	none			1						1	Chills; Hyperhidrosis; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~5/6/03 inactive~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0212346	11/14/2003	MI	31.0	31		F	11/14/2003	Received Influenza vaccine 10/3/03. Arm became very swollen and bruised. This lasted approx. 3 weeks. Arm is still sore and slightly discolored 5 weeks after vaccine given.									Y	10/03/2003	10/03/2003	0		PUB	PVT	None	No	No			1						1	Contusion; Pain; Skin discolouration; Swelling	FLU3~PFIZER\WYETH~U1268AA~1~IM~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0212411	11/14/2003	CA	74.0	74		F	11/14/2003	Pt staes she felt dizzy and weak with intermintent trembles in hte evening after receiving flu shot. Pt states she has received vaccine in recent years with no adverse effects. Pt had temp of 101.3F when admited to ER.				Y					Y	11/12/2003	11/12/2003	0	none	MIL	MIL	Zocor, nebulizer	none	Asthma			1						1	Asthenia; Dizziness; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U1098AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212413	11/14/2003	CA	39.0	39		F	11/14/2003	Symptoms and Electromyelogram results consistent with Guillain-Barre Syndrome. Medical records state decreased reflexes, asthenia, otosis, ataxia. msv				Y					N	10/22/2003	11/03/2003	12	Electromyelogram. Medical records state abnormal lab test. msv	UNK	UNK	Multi-Vitamin	NONE	NONE			1						1	Coordination abnormal; Eyelid ptosis; Guillain-Barre syndrome; Hyporeflexia; Laboratory test abnormal	FLU3~EVANS VACCINES~765751~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212414	11/14/2003	MN	70.0	70		F	11/14/2003	Patient Recieved Vaccine at 11:00 am on 10-13-03 at 1:30pm Patient noticed a sore arm and Muscle stiffness and reports can't lift arm without pain.									Y	11/13/2003	11/13/2003	0		UNK	PUB						1						1	Joint range of motion decreased; Musculoskeletal stiffness; Pain	FLU3~EVANS VACCINES~765485~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212416	11/15/2003	MA	28.0	28		F	11/15/2003	High Fever with shivering body ache specially in the back									Y	11/14/2003	11/14/2003	0		PVT	UNK						1						1	Back pain; Chills; Pain; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0212417	11/15/2003	IL	1.3	1	.3	M	11/15/2003	1 day after receiving the flu shot my son had flu like symptoms, low grade fever, runny nose, irratable.  He also seems to have a lot of balance problems and is extemely irratable.									Y	10/14/2003	10/15/2003	1		UNK	UNK						1						1	Balance disorder; Irritability; Pyrexia; Rhinorrhoea	DTAPH~UNKNOWN MANUFACTURER~~UNK~~~DTAP + HIB (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212418	11/15/2003	TX	0.0	42		F	11/15/2003	headache, fever, listless, aches in back, arms, legs, upset stomache, burning eyes occured soon after still continuing after 24 hrs									U	11/14/2003	11/14/2003	0		UNK	UNK	none	none	none			1						1	Back pain; Eye irritation; Headache; Listless; Pyrexia; Stomach discomfort	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212420	11/16/2003	NJ	27.0	27		M	11/16/2003	While waiting for record completion after four shots were administered, Patient experienced lightheadedness and lost his balance. Patient landed in a seated position.				Y					Y	11/15/2003	11/15/2003	0		MIL	MIL	None	None	None			1						1	Balance disorder; Dizziness	FLUX~UNKNOWN MANUFACTURER~PJW765754~UNK~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~5377A4~UNK~IM~RA~HEP B (ENGERIX-B)~1|MEN~SANOFI PASTEUR~UB493AA~UNK~ID~LA~MENINGOCOCCAL (MENOMUNE)~1	USA	Emergency room visit	Influenza
0212421	11/16/2003	TX	0.0	64		F	11/16/2003	Vaccinated between 12: and 1:00pm on 11/13/03.  On 11/14/03 around noon, began to get a sore throat, got progressively worse that day; 11/15 developed fever, sleepiness, dizziness, throat congestion; today (11/16) have all same symptoms plus feeling faint, have  body aches, and cold symptoms including bad headache, nasal drip, and upper respiratory congestion including wheezing.  (NATURALLY THIS WOULD HAPPEN ON THE WEEKEND, CANNOT CONTACT THE CLINIC)... taking OTC cold medications.									Y	11/13/2003	11/14/2003	1		PUB	UNK	Synthroid, Premarin	None	None			1						1	Dizziness; Headache; Nasal congestion; Pain; Pharyngitis; Pharyngolaryngeal pain; Pyrexia; Rhinitis; Rhinorrhoea; Somnolence; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212422	11/16/2003	DC	59.0	59		F	11/16/2003	REDNESS AT SITE  BY EVENING HAD HIVES ON BOTH FOREARMS - INSIDE BETWEEN WRIST AND ELBOW AND THEN AT ELBOW -- LARGE AND RESEMBLED CELLULITIS WITH ITCHING, HOT, SWOLLEN AND SPREADING  ELEVATED HEARTRATE = 113  TOOK CLARITIN AND ASPIRIN; APPLIED COLD COMPRESSES; RESTED - MUCH REDUCED THE NEXT DAY									Y	11/15/2003	11/15/2003	0	NA	PVT	UNK	PREMPRO COZAAR		HAD CELLULITIS FROM BEE STING IN AUGUST, 2003;			1						1	Heart rate increased; Injection site erythema; Injection site warmth; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212423	11/16/2003	MA	53.0	53		F	11/16/2003	Light headed, dizzy, nauseous, pins and needles in fingers, burning sensation at top of throat, difficulty swallowing - golf ball sensation on right side of throat, sensation up to right ear.				Y					Y	10/27/2003	10/27/2003	0	had labs and ecg done	UNK	UNK			Allergic to cats and oxytocin			1						1	Dizziness; Dysphagia; Nausea; Paraesthesia; Pharyngolaryngeal pain	FLU3~EVANS VACCINES~765669~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212260	11/17/2003	NC	43.0	43		M	11/12/2003	10/7/03: received anthrax #1, together with influenza, typhoid, hep B #1, Hep A #2 and repeat smallpox vaccines. 10/16/03: started to feel a burning, itching sensation on his lower left calf, noticed a large blister surrounded by multiple small blisters on his lower left calf, lesions nontender, moderately pruritic, erythematous and edematous, no c/o f/c or malaise. 10/17/03: size and number of lesions decreased, most blisters got popped and some have already crusted over, no longer c/o burning sensation, less edema, erythema and pruritis noted. Pt seen at health center, denied any other blisters on body or having any lesions in his mouth. H/o chronic dry skin o/w unremarkable, FH insignificant, no h/o allergies, on no meds, no recent exposure to poison ivy or chicken pox, no field exposure, no recent h/o friction/trauma to the area, no recent new skin product use. Pt in NAD, afebrile 10/20/03, no c/o sx/sx of infection 10/27/03. Lesions now replaced by dry black-colored scabs, no sx/sx of infection. Will obtain sera for the presence of pemphigus antibody. A copy of the pt's summary mailed to VAERS on 11/12/03.				Y					Y	10/07/2003	10/16/2003	9	Pemphigus antibody - pending	MIL	MIL	NONE	NONE	Chronic dry skin			1						2	Blister; Erythema; Pruritus; Skin burning sensation; Skin ulcer; Blister; Injection site erythema; Injection site reaction; Oedema; Pruritus; Skin burning sensation; Skin ulcer	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~FAV075~2~~RA~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|HBPV~UNKNOWN MANUFACTURER~~UNK~~~HIB POLYSACCHARIDE (NO BRAND NAME)~2|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~2|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~2|SMALL~PFIZER\WYETH~FAV075~2~~RA~SMALLPOX (DRYVAX)~2|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0212351	11/17/2003	CT	71.0	70		F	11/10/2003	Dizziness and nausea 4 hours. To ER; given Benadryl and chest pain 6 hours. Nitro patch; EKG and blood work negative for MI. Medical records state vertigo, vestibular disorder. msv				Y	Y	1			Y	10/24/2003	10/28/2003	4	Medical records state alk phos increased. msv	OTH	UNK	Tenormin, Lipitor	NONE	Hypertension, hypercholesterolemia, breast cancer & reconstruction of eardrum Medical record states allergy. msv			1						1	Blood alkaline phosphatase increased; Chest pain; Dizziness; Nausea; Vertigo; Vestibular disorder	FLU3~EVANS VACCINES~765745~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0212353	11/17/2003	MA	7.0	7		M	11/10/2003	Left arm redness, edema, tenderness beginning morning after flu shot. Admitted to hospital on 11/8/03 for 48 hours for cellulitis IV therapy.				Y	Y	2			Y	11/06/2003	11/07/2003	1	Culture done; result not yet known.	MIL	MIL	NONE	NONE	Asthma			1						1	Injection site erythema; Oedema; Tenderness	FLU3~EVANS VACCINES~765756~2~ID~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0212355	11/17/2003	PA	2.0	2	.2	M	11/14/2003	Diffuse swelling of LUE with minimal swelling LLE and hand area hot to touch (LUE). Not inflamed. Painful-child not moving arm. Seen in ER prescribed antibiotic treating pos cellulitis. Mother has been advised child has an egg allergy not known to her. Medical records state anemia, bacterial infection				Y	Y	1			Y	10/31/2003	11/04/2003	4	nONE Medical records state leukocytosis, lab test abnormal. msv	OTH	PVT	NONE	NONE Medical records state fever. msv	NONE			1						1	Anaemia; Bacterial infection; Cellulitis; Feeling hot; Hypokinesia; Laboratory test abnormal; Leukocytosis; Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~U11348A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0212363	11/17/2003	CA	48.0	48		F	11/14/2003	Painful, swollen, itchy eye; mild facial swelling, tight chest, lethargy and fatigue; mild nausea. Eye pain and swelling 2-3 hours after vaccine.									N	10/13/2003	10/13/2003	0		OTH	OTH			Seasonal allergies, penicillin			1						1	Chest discomfort; Eye oedema; Face oedema; Fatigue; Lethargy; Nausea; Pain; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212364	11/17/2003	PA	8.0	8		F		Local swelling, pain, fever									Y	11/12/2003	11/13/2003	1	NONE	PVT	UNK		NONE	NONE			1						1	Injection site oedema; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1264AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1026M~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212365	11/17/2003	TX	66.0	66		F	11/14/2003	Only symptom was painful left arm when moved. Onset approx 45 minutes after immunization. Tx: Tylenol and cold compresses. As of 11/12, left arm remains painful to move.									Y	11/10/2003	11/10/2003	0	NONE	PUB	PUB	Glucophage, Toprol, thyroid med	NONE	NONE		SA0316	1						1	Pain	FLU3~SANOFI PASTEUR~U1123AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0947N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212366	11/17/2003	IA	66.0	66		F	11/13/2003	C/o of left arm being red and swollen, warm to touch. Denies fever. Told to use ice to arm and take Tylenol.									Y	11/03/2003	11/04/2003	1		PVT	PVT	Fosamax, Zyrtec	NONE	Osteoporosis, cancer of breast			1						1	Feeling hot; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1136AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1026M~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212367	11/17/2003	IA	81.0	81		F	11/13/2003	Our office was closed on 10/22/03 so pt didn't report until 10/23/03. C/o of redness and swelling at injection site. Denied fever. Told to ice arm and take Tylenol.									Y	10/21/2003	10/22/2003	1		PVT	PVT	Actonel, Coumadin, Avandia	NONE	TIA, arthritis hand			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1136AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1026M~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212368	11/17/2003	IA	65.0	65		F	11/13/2003	101 temp, achy body, 3 x 5 area red and warm to touch. Pt didn't report to us until 10/27/03.									Y	10/21/2003	10/22/2003	1		PVT	PVT	Erista, Atenolol, Celebrex, Darvocet	NONE	Rheumatoid arthritis			1						1	Feeling hot; Injection site erythema; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1136AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1026M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212369	11/17/2003	OR	46.0	46		F	11/13/2003	Diagnosed in ER as an allergic reaction. Released same day, given epinephrine and Benadryl.				Y					Y	11/13/2003	11/13/2003	0	None	PUB	PUB	Tylenol, allergy medication	No	Hives from sulfa drugs			1						1	Hypersensitivity	FLU3~SANOFI PASTEUR~U1090AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212370	11/17/2003	PA	9.0	9		F	11/14/2003	Fever to max of 104 by oral thermometer. Extremely tender left arm and injection site with redness locally, mild induration, and no fluctuance. Given Augmentin orally/antipyretics.									U	11/12/2003	11/12/2003	0	NONE	PVT	UNK		NONE	NONE			1						1	Injection site erythema; Injection site induration; Pain; Pyrexia	FLU3~SANOFI PASTEUR~1264AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1026M~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212371	11/17/2003	WI	33.0	33		F	11/12/2003	Approx 10 minutes after receiving flu shot into left deltoid, began c/o strange sensations in left underarm and left breast. No resp Sx, no egg allergy. Denies pain. Likens sensation to engorgement with increased sensation of warmth.									U	11/11/2003	11/11/2003	0		OTH	OTH	NONE	NONE	NONE			1						1	Breast engorgement; Feeling hot	FLU3~EVANS VACCINES~765707~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212372	11/17/2003	CT	1.5	1	.5	M	11/14/2003	3 circumference, reddened area, warm, pruritic noticed guestimate 24 hours after receiving injection. PCP office notified 48 hours, pt to receive ibuprofen (100mg/5ml) 1/2 tsp every 6-8 hours prn, Benadryl (12.5mg/5ml 1 tsp every 6 hours prn. No fever noted, local reaction observed by mom.									N	11/12/2003	11/13/2003	1		PVT	PUB		NONE	NONE			1						1	Feeling hot; Injection site erythema; Injection site oedema; Pruritus	DTAP~GLAXOSMITHKLINE BIOLOGICALS~616A2~4~IM~LL~DTAP (INFANRIX)~1|FLU3~EVANS VACCINES~766052~1~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~W1233~3~IM~RL~POLIO VIRUS, INACT. (POLIOVAX)~1	USA		Influenza
0212373	11/17/2003	MD	89.0	89		M	11/12/2003	Pt reported he received Flu vaccine at 12:00 PM. At 4 PM developed left shoulder pain (bursitis) lasting 3 days then developed severe right UE pain (opposite of injection site). Pain moves joint to joint.									Y	11/03/2003	11/03/2003	0		PUB	PUB	NONE	NONE	PCN, cancer bladder			1						1	Arthralgia; Bursitis	FLU3~EVANS VACCINES~765416~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212374	11/17/2003	OH	61.0	61		M	10/13/2003	Onset of muscular and joint pain stiffness aching. Time course of 7 days, treated with aspirin.									Y	10/02/2003	10/05/2003	3	NONE	PUB	PVT	Aspirin, Prevacid	NONE	NONE			1						1	Arthralgia; Joint stiffness; Musculoskeletal stiffness; Myalgia; Pain	FLU3~SANOFI PASTEUR~U1141AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212375	11/17/2003	UT	74.0			F	10/28/2003	Pt received a flu vaccine at 2:15. Had itchy face, head, chest within 10-15 minutes. It became progressive. Gave Benadryl approx 35 minutes after vaccine. Itchiness subsided within 10 minutes.									Y	10/27/2003	10/27/2003	0	NONE	PUB	PUB		NONE	Allergies vancomyicin			1						1	Pruritus	FLU3~EVANS VACCINES~765874~4~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212376	11/17/2003	MA	18.0	18		M	11/11/2003	Fever 101.7 F to 101.4 with malaise for 24 hours then resolved. No erythema, no induration at injection site.				Y					Y	10/24/2003	10/30/2003	6		OTH	PVT	Levoxyl, Genotropin, Cortef, Testisclone, ASA, Depakote, Ramitidine		S/P intercranial tumor; pituitary insufficiency; visual and hearing deficits; seizure disorder; allergy to Dilantin			1						1	Malaise; Pyrexia	FLU3~SANOFI PASTEUR~U1068AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212377	11/17/2003	IL	53.0	53		F	11/07/2003	11/01/2003 @ 16:00, starting itching on trunk and upper limbs and had red blotching for one week.									Y	10/30/2003	11/01/2003	2	NONE	OTH	OTH	NONE	NONE	Bronchial pneumonia 6 weeks before	itching~Influenza (Seasonal) (no brand name)~1~52.00~In Patient		1						1	Erythema; Pruritus; Rash macular	FLU3~SANOFI PASTEUR~U1128AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212378	11/17/2003	OH	67.0	67		F	11/06/2003	11/05 @ 23:00: Onset of dizzyness, took antivert. 11/06 @ 08:00: Vertigo continued, slightly hoarse.									U	11/04/2003	11/05/2003	1	NONE	PUB	PUB	Synthroid; Toprol	NONE	History of vertigo; Viral Infection - 1 month prior			1						1	Dizziness; Dysphonia; Vertigo	FLU3~SANOFI PASTEUR~U1098AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212379	11/17/2003	WV	30.0	30		M	10/16/2003	Patient states that he's developed numbness of right arm and fingers.  12 hours after immunization in same arm  Lasted two hours.  Later developed shaking, chills, and flu-like symptoms and nausea.									Y	10/15/2003	10/15/2003	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Hypoaesthesia; Nausea; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U1074AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212380	11/17/2003	WV	49.0	49		M	10/16/2003	Tingling fingers 20 minutes after immunization in same arm which lasted about 5 minutes.  Developed chills during night.  Didn't temperature.									Y	10/15/2003	10/15/2003	0	NONE	PVT	PVT	NONE	Sore throat prior to immunization	NONE			1						1	Chills; Paraesthesia	FLU3~SANOFI PASTEUR~U1074AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212381	11/17/2003	NV	70.0	70		F	11/06/2003	Patient received injection at 17:30 her head started itching at 19:00 her hands, wrists were itching at 21:00.  She noted blotches and itching on her trunk, hips and legs and upper lip was swollen.  She visited her physician on 10/30 and received Allegra for the symptoms.  This alleveated her symptoms.				Y					Y	10/29/2003	10/29/2003	0	NONE	PVT	PVT	Lotensen; Lipitor; Synthroid; Prilosec; Elmiron;	NONE	Allergic to PCN.			1						1	Oedema; Pruritus; Rash macular	FLU3~SANOFI PASTEUR~U1092AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212382	11/17/2003	VA	2.0	2	.0	F	11/11/2003	Flu shot 11/04/2003.  Today temperature 100.3, congestion, cold increased left arm, reddened, hard, hot to touch (left arm).  According to mom, no reaction last night when bathed.  11/07/2003: MD from mom analisc's arm, swelling decreased not as hot to touch.									Y	11/04/2003	11/06/2003	2	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site warmth; Nasal congestion; Pyrexia	FLU3~SANOFI PASTEUR~U1147AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212383	11/17/2003	VA	31.0	31		F	11/10/2003	30 minutes after flu vaccine left deltoid.  She began to itch in nose IM Benadryl 25mg left hip.  125 mgm solu medial IM right hip.  Tagamet 400mg.  O2 2<min canned.  Hard to swollen blood pressure 28/74, pulse: 75; respiratory 18; 11:40: feeling better. Pulse Ox 99%.  Stable to home.				Y					Y	11/10/2003	11/10/2003	0	Systemic reaction to flu vaccine today.	MIL	MIL	Allegra; Norapamil; Paxil; Trazadone;	NONE	Doxycyclin, ASA, Demerol, Cornpazine, Robitussin, Morphine, Aciplex, Motrin; Triloutaline, Darvacet.			1						1	Pruritus	FLU3~SANOFI PASTEUR~U1269AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212384	11/17/2003	WI	92.0	92		F	11/08/2003	No inflammation at injection site.  Tingling in the arm and fingers IM injection. Within 15 minutes of injection, shortness of breath and tightness of chest, bloating of lateral area. Treatment x 1 epipen with patient laing down with head elevated. Immediately upon administration all symptoms resolved.				Y					Y	11/08/2003	11/08/2003	0	Patient sent to ER to follow-up with EMT team.  ER physician and daughter called me.  Confirmed.  No abnormalities on all lab tests.	OTH	OTH	Hyoseyamine; Prilosec; Isosorbide dN	NONE	NONE			1						1	Abdominal distension; Chest discomfort; Dyspnoea; Paraesthesia	FLU3~EVANS VACCINES~76550~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0869N~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212385	11/17/2003	GA	25.0	25		F	11/10/2003	Shortly after receiving the vaccine (approximately 5-10 minutes).  She felt warm similar to how she felt when she had received an epidural for labor pains.  She developed a metallic taste (mouth full of nickels) which subsided 15 minutes later without treatment.									Y	10/07/2003	10/07/2003	0	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Dysgeusia; Feeling hot	FLU3~EVANS VACCINES~765412~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212386	11/17/2003	CA	14.0	14		M	11/08/2003	Rash-hives occurred with some eye swelling the morning after injection given.									Y	11/07/2003	11/08/2003	1	NONE	PVT	PVT	NONE	NONE	Mild asthma			1						1	Eye oedema; Rash; Urticaria	FLU3~EVANS VACCINES~U1143AA~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212388	11/17/2003	LA	1.2	1	.2	F	11/06/2003	Rash all over body.  Small red dotes/whelps in some areas.  Epi injection per ER.  Prescribed Benadryl, now Atarax.				Y					U	11/03/2003	11/03/2003	0	NONE	PVT	PVT	Robitussin CF; Zyrtec	Upper Respiratory Infection	AR			1						1	Erythema; Rash	FLU3~SANOFI PASTEUR~U1266AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212389	11/17/2003	MT	47.0	47		F	11/04/2003	By 17:00: redness, hot lump and skin starting, sore.  At bedtime, sore, hot and chills.  11/04/2003 @ 08:15am: 90cm diameter welt-red, hot, sore.  No itching, aching no difficulty breathing.  11/06/2003: Welt red but going down.									Y	11/03/2003	11/03/2003	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Chills; Erythema; Injection site mass; Injection site pain; Injection site warmth; Urticaria	FLU3~EVANS VACCINES~765952~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212390	11/17/2003	IL	43.0	43		F	11/07/2003	States complained of sore left arm (deltoid area) approximately 18:00 on 11/06/2003.  Awoke at 13:30 on 11/07/2003 with complaints of increased soreness and itching in left lower arm and fingers.  States took antihistamine and Estylenol at 13:30.									Y	11/06/2003	11/07/2003	1	NONE	OTH	PVT	Necon; Levoxyl	NONE	Seasonal allergies/PCN, PMH-hypothyroidism			1						1	Injection site pain; Pruritus	FLU3~SANOFI PASTEUR~U1094AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212391	11/17/2003	VA	48.0	48		F	11/10/2003	Complained of tongue/lip tingling and numbness evening of date receiving flu shot (11/04/2003).  Progressed over next 2 days to left sided facial paralysis.  Diagnosis: probable Bell's Palsy by PMD; placed on steroids.				Y					U	11/04/2003	11/04/2003	0	NONE	OTH	PVT	UNK	UNK	UNK			1						1	Facial palsy; Hypoaesthesia; Paraesthesia	FLU3~EVANS VACCINES~765495~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212392	11/17/2003	VA	58.0	58		M	11/10/2003	C/O dizziness, malaise, pain, L arm 2 hrs post rec flu shot. BP increased 180/100-155/90 over next several hrs. HR wnl. No hx HPTN or CAD. Eval by PMD at 4:30 that day-placed on HPTN meds. BP remained high in MD office according to client.				Y					Y	11/07/2003	11/07/2003	0	BP 180/100-155/90; HR wnl.	OTH	PVT	UNK	NONE	UNK			1						1	Blood pressure increased; Dizziness; Malaise; Pain	FLU3~SANOFI PASTEUR~U1077AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212424	11/17/2003	MI	56.0			F	11/17/2003	none Medical records state dehydration, chest pain, decresed coag time,anemia, asthenia, diarrhea, myalgia. msv									Y	10/17/2003			INR-116.13 PT-99.2 PTT-200 Medical records states leukocytosis, hypokalemia. msv	UNK	UNK		NONE	HYPOTHYROIDISM,S/P MITRAL AND AORTIC VALVE REPLACEMENT-1998,GASTRIC BY-PASS-1975,PACEMAKER PLACEMENT-1992 Medical records state cerebrovascular accident. msv			1						1	Anaemia; Asthenia; Chest pain; Coagulation time shortened; Dehydration; Diarrhoea; Hypokalaemia; Leukocytosis; Myalgia; Unevaluable event	FLU3~EVANS VACCINES~765601~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212425	11/17/2003	NC	70.0	70		F	11/17/2003	Pneumococcal (Left arm)Influenza (Right arm) 05 Nov 2003 Received vaccinations on this date.  No complaints.    07 Nov 2003 Presented to VHC for evaluation.  Reports left arm sore from pneumococcal vaccination.  Concerned regarding the red ring surround site.  Last received the pneumococcal vaccination 5 years previously at the age of 65 after having had pneumonia.  No problems noted after that vaccination.  Feels fine except for tender, red arm. Denies fever, chills, chest pain, or shortness of breath.  Assessment:  1. Arthus reaction to Pneumococcal vaccination.  Plan/ Recommendations:  1.  Discussed etiology of arthus reaction.  The redness does not indicate a bacterial infection, and no antibiotics are needed. 2. Meds:  Kenalog 0.1% cream apply tid x 5 days. 3. May use Tylenol or Motrin (with food) for comfort. 4. Heating pad for 20 minutes four to five times a day to affected area for comfort. 5. If any signs of infection develop, such as drainage, red streaking, fever, or chills, call or return to our office or the ER. 6. Current guidelines recommend the pneumococcal vaccination as a one-time dose with a one-time revaccination booster 5 years after the first dose for high risk people and those >= 65 if the first dose was given prior to age 65.  As this was her second dose, she does not require any further boosters at this time.  ***However, should immunization guidelines change with a recommendation for further pneumococcal boosters, it is strongly recommend that patient have pneumococcal titers drawn prior to receipt of further vaccination to assess for residual immunity.  We also recommend evaluation by a provider with expertise in adverse vaccine management if further pneumococcal vaccinations are needed.				Y					U	11/05/2003	11/07/2003	2	None	MIL	MIL	Medications: o Tenormin 50 mg QD o HCTZ 25 mg QD o Synthroid 125 mcg o Allegra 180 mg QD o Motrin prn  Complementary & Alternative Medicine Use: o Glucosamine & Chondroitin	None	Past Medical History: o HTN, Hypothyroidism, OA, Allergic Rhinitis   Allergies/ Adverse Drug Reaction History: o No drug or food allergies. o No past reactions to vaccinations.			1						1	Injection site erythema; Injection site pain; Type III immune complex mediated reaction	FLUX~UNKNOWN MANUFACTURER~Unknown~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~Unknown~2~IM~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0212427	11/17/2003	OH	30.0	0	.6	F	11/17/2003	Received influenza vaccine in L deltoid (posterior/superior aspect) 10/29/03.  Reports that she had immediate pain with numbness/tingling radiating down her L arm to palmar aspects of all digits. Symptoms waned in about 1 hour, but persisted.  Presents 11/17/03 with one day of increased tenderness/pain at injection site with decreased range of motion L shoulder (abduction & elevation)and L arm/hand numbness & tingling.									U	10/29/2003	10/29/2003	0		PVT	PVT	Allegra, Ibuprofen		Allergy to Amoxicillin, History IBS (irritable bowel syndrome)			1						1	Hypoaesthesia; Injection site pain; Joint range of motion decreased; Paraesthesia	FLU3~EVANS VACCINES~765876~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212429	11/17/2003	CO	72.0	72		F	11/17/2003	Nov. 4: ER for pain, edema at vacc. site, bruising to elbow. heat with ibuprofen Nov. 6: visit to Clinic.  edema of entire arm, bruising to wrist, large indurated area at vacc. site.				Y					Y	10/27/2003	11/01/2003	5		UNK	UNK	Coumadin, Captrotil, Gemfibrozil,HCTZ, K-Dur, Lasix,ASA, Spironolactone, Lanoxin, Welchol, Zocor, Coumadin, Premarin, Fosamax		Myocardial infarct. CABG 1979, 1998 AAA 1990 paradoxical embolus-optic nerve L eye affected 2000			1						1	Contusion; Injection site induration; Injection site pain; Injection site swelling; Injection site warmth; Oedema peripheral	FLU3~SANOFI PASTEUR~U1076AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212430	11/17/2003	IN	39.0			F	11/17/2003	Approx. 10 min. after recieving flu vaccine began feeling 'funny-nausea, darkened vision, hot, hearing muffled--no c/o difficulty breathing or swallowing.  Face reddened across cheeks similar to rash.  Skin warm and dry, color pale with red cheeks, resp. unlabored but fast. 911 called and .8 mg Epinephrine 1:1000  administered. Began feeling better--color improved within 5 minutes-rash disappeared, vision improved. Transported to Emergency Room per EMS.				Y					Y	11/12/2003	11/12/2003	0		UNK	PVT	Paxil extended relase	none	Environmental allergeis			1						1	Dry skin; Feeling hot; Flushing; Hypoacusis; Nausea; Pallor; Respiratory rate increased; Visual disturbance	FLU3~EVANS VACCINES~765883~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212431	11/17/2003	SC	47.0	47		F	11/17/2003	ON 11/05/03, PATIENT DESCRIBED SEVERE RIGHT ARM PAIN WITH LARGE AMOUNT OF REDNESS AND SWELLING - SEEN AT LEXINGTON MEDICAL CENTER ER (PRIOR TO ER VISIT,VOMITED-ARM POUNDING AND TURNING RED ON 11/04/03, 2 HOURS POST IMMUNIZATION ADMINISTRATION). GIVEN DILAUDID AND BENADRYL. INSTRUCTED TO USE ICE ON ARM X 2 HOURS, THEN HEAT.				Y					Y	11/04/2003	11/04/2003	0		PUB	PUB	Procronic, Quinine sulfate, Duragesic patch, Lorcet/Baclosen, hormone therapy	NONE	Anti-inflammatory meds/ ASA (GI symptoms)  Fibromyalgia		Sc0345	1						1	Injection site erythema; Injection site pain; Injection site swelling; Vomiting	FLU3~SANOFI PASTEUR~U1145AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~6685N~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212434	11/17/2003	NJ	65.0	65		F	11/17/2003	Supraclavicular swelling and adenopathy to left side (side of the vaccine)				Y					Y	10/20/2003				UNK	UNK						1						1	Lymphadenopathy; Swelling	FLU3~SANOFI PASTEUR~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212533	11/17/2003	MA	23.0	23		M	11/17/2003	The vaccine was administered on 11/13/2003 at the advertised Free Flu Shot Clinic. I started getting a headache and felt a sore throat by 11/15. Right now I experience headaches, occasional fevers, dry mouth, sore throat no cough, muscle pain, general weakness.									U	11/13/2003	11/15/2003	2		PUB	UNK						1						1	Dry mouth; Headache; Pharyngolaryngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212534	11/17/2003	LA	76.0	76		F	11/17/2003	Patient presented to ED with weakness and shaking at 10pm. Temperature 100.5 F. Denies SOB, cough, diarrhea. Mild crackles at LLL. CXR shows atelactasis vs. mild pneumonia. Started on Omnicef and Liquibid. Admitted to hospital for observation. on 10/9/03 pt was to be discharged, progress notes state reason for admission was immunologic reaction to flu vaccine. While preparing patient for discharge, she become hypoxic with a PO2 of 56. Discharge canceled and patient placed on O2, Rocephin and Zithromax.  CT of thorax to rule out PE was negative. Pt. discharged 48 hours later with no further problems. The discharge summary states viral syndrome, and imunologic reaction flu.				Y	Y	3			Y	10/07/2003	10/07/2003	0	CXR- mild vascular congestion CBC-90.9% neutrophils Blood and Urine cultures- negative Comprehensive Metabolic Panel- negattive	UNK	UNK	Colace, Duragesic, Lexapro, Reglan, Pacerone, Demadex, Lipitor, Coumadin, Aldactone, Percocet	Unknown	Hypertension, Hypercholesteremia, Arthritis, Pacemaker (dual), CABG with valve replacement, Kidney removed,Depression, CAD, neurogenic pain			1						1	Asthenia; Atelectasis; Hypoxia; Laboratory test abnormal; Pyrexia; Tremor; Viral infection	FLU3~SANOFI PASTEUR~1255AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0212535	11/17/2003	NY	34.0	34		F	11/17/2003	Patient stated that she had disconfort in right arm 30 minutes after administration. Pt states her arm hurt later that night that I could not lift it to take my blouse off. The next morning pt states her arm where the injection was administered was red and hot and that under her arm was red, hot and slighly swollen. Pt was seen and examined on 11/11/03 and he told her she had a reaction to the pneumonia vaccine. He prescribed Cefadroxil 500mg PO BID X 7 days and Methylprednisone 4mg PO QD X 21 days.				Y					Y	11/11/2003	11/11/2003	0		UNK	PVT	None known	none known				1						1	Injection site erythema; Injection site swelling; Injection site warmth; Joint range of motion decreased	FLU3~EVANS VACCINES~766050~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0257N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212437	11/18/2003	LA	51.0	50		F	11/13/2003	Information has been received from a physician concerning a 51 year old female patient with hepatitis C who on 10/30/02 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included influenza virus vaccine (unspecified) on 10/30/03, ribavirin and peginterferon alfa-2b for hepatitis. On 11/1/03 the patient had respiratory difficulties and on 11/3/03, she was hospitalized in the ICU and intubated. It was noted that the patient had ARDs symptomatology. It was also noted that she had multiple lab work and x-rays and was seen by a pulmonologist. This report did not involve a product quality complaint. No further information is available.				Y	Y				U	10/30/2002	11/01/2003	367	UNK	OTH	OTH	Peg-Intron; Rebetol		Hepatitis C		WAES0311USA00663	1						1	Acute respiratory distress syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0212438	11/18/2003	KS	39.0	39		F	11/13/2003	Information has been received from a 39 year old female consumer with allergies to bees and amoxicillin (+) clavulanate potassium who on 10/31/03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine in the right arm. Concomitant therapy included montelukast sodium and Ester dial patch. By the afternoon on 10/31/03, her right arm began to swell from her shoulder to a little below the elbow. She says that her arm was so swollen that she could not move her right arm or do her daily routine. The pain was so intense that she was unable to move. She felt that she was going to die. Her daughter in law's father is a physician who told her to take an antihistamine, which did not work. In the morning of 11/1/03, her arm was very swollen three times its normal size and she had a fever, headache and nausea. As of 11/03/03, her arm was still swollen and she was still complaining of a headache. She also reported that she had a raised white spot on her arm. She reported that her physician is a friend of hers and he is already aware of her situation. Unspecified medical attention was sought. There was no product quality complaint involved. On 11/6/03 the nurse reported that they had no information to add. The patient's events were considered to be immediately life threatening and disabling. Additional information has been requested. A 15-day follow up report received 12/10/2003 adds: Follow-up info received 11/25/2003 from the nurse indicated that on 10/31/2003 at 3 PM, the pt experienced redness, swelling and discomfort in the IM site which lasted for 5 days. The pt recovered and her events were not considered to be life-threatening or disabling by the reporting health care professional. The pt considered her events to be immediately life-threatening and disabling. No further info is expected.			Y	Y				Y	Y	10/31/2003	10/31/2003	0		PVT	PVT	Singulair, Proventil, estradiol, Allegra	Right upper quadrant pain	Allergic reaction to bee sting; Drug hypersensitivity		WAES0311USA00151	1						1	Erythema; Headache; Joint range of motion decreased; Nausea; Oedema peripheral; Pain; Pyrexia	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Disabling	Influenza
0212462	11/18/2003	TX	84.0	84		F	10/20/2003	Pt given pneumovac on 10/15/03 with her Influenza on different arms. Later the same afternoon c/o redness, swelling and pain at the site of pneumovac. Was instructed to take Tylenol, Benadryl and apply warm compress to site. On 10/16/03 pt went to ER. Site marked per ER doctor, to return to clinic in AM, was given Rx for Tylenol 650mg. Pt came in to clinic on 10/17/03 to see NP, Dx local reaction to pneumovac. No change in site marked per ER doctor. On 10/23/03 called pt for follow up, no redness, doing fine.				Y					Y	10/15/2003	10/15/2003	0	NONE	PVT	PVT	NONE					1						1	Injection site erythema; Injection site oedema; Pain	FLU3~SANOFI PASTEUR~U1081AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0944N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212463	11/18/2003	TX	59.0	59		F	10/24/2003	Became very dizzy, severe nausea and vomiting				Y					Y	10/14/2003	10/14/2003	0	UNK	PVT	PVT		NONE	Claritin, Amaryl			1						1	Dizziness; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U1081AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0944N~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212464	11/18/2003	TN	42.0	42		F	11/06/2003	Received flu and pneumonia shots in left arm on 10/27/03. RTC 10/31/03 with c/o left arm swollen, feverish, itching and sore. Told to see MD. Phone call to clinic 11/6/03, states went to MD on 10/31/03. Had increased WBC count. Placed on antibiotic for 10 days. States look better today, still sore.				Y					U	10/27/2003	10/30/2003	3		PUB	UNK		NONE	NONE		TN03069	1						1	Injection site oedema; Pain; Pruritus; Pyrexia; White blood cell count increased	FLU3~EVANS VACCINES~765797~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0675M~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212465	11/18/2003	TN	50.0	50		F	10/23/2003	Fever ranging from 101-103 degrees beginning the PM that pneumonia and flu vaccines were administered. Denies local reaction. Follow up on 04/21/04: Spoke with caregiver regarding fever noted after receiving Flu and Pneumovax injections on 10/21/03.  Caregiver stated that later that evening after receiving vaccines, pt developed a fever ranging from 102 to 103 degrees.  The caregiver did not, she stated take pt to the doctor for a consultation, but, the fever did break by the next day.  The caregiver stated that there was on inflammation noted at the injection site, and pt is better now.									U	10/21/2003	10/21/2003	0		PUB	PUB			Past history: breast cancer, traumatic brain injury		TN03068	1						1	Pyrexia	FLU3~EVANS VACCINES~765797~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1026M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212466	11/18/2003	TN	77.0	77		F	10/16/2003	Pt developed a raised red rash from sternum to spine on left side of body, underneath left breast, no pain or itching associated with rash. Pt received Flu and Td vaccine on Monday, 10/13/03, noticed rash on Wednesday, 10/15/03. States did not do anything different except worked in yard and looked for hickory nuts. No rash on arms. Right arm (tetanus) slight swelling (local reaction), suspect Herpes Zoster/see attached pictures. Sent pt to family physician. Physician confirmed Herpes Zoster and treated with Acyclovir. Does not appear to be vaccine reaction.				Y					U	10/13/2003	10/15/2003	2		PUB	PUB	Multivitamins, Glucosamine, Calcium	NONE	NONE		TN03066	1						1	Herpes zoster; Injection site oedema; Rash erythematous	FLU3~EVANS VACCINES~765797~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~SANOFI PASTEUR~40833AA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0212467	11/18/2003	MI	45.0	45		F	11/17/2003	Had flu shot 10/20/2003 during day. Went to ER that night for itching, redness, urticaria (generalized). Received Solu Medrol and Benadryl. Returned to ER on 10/22 for return of red rash, itching, hives. No resp. problems. Received Solu Medrol 125mg IM, Phenergan 50mg IM, Tramerlone cream 0.625.				Y					Y	10/23/2003	10/23/2003	0		PUB	OTH	Lisinopril/HCTZ, Prozac, Premarin, Synthroid, Lipitor, Iodine Nexium, B12, Mag/calcium, multivitamin	NONE	HTN, Hypothyroid, cystic ovary			1						1	Injection site erythema; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1268AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212468	11/18/2003	WA	62.0	62		F	11/11/2003	Shot arm swelling and throbbing to fingertips. Stiff neck and back of head hurt. Extreme diarrhea and violent vomiting. Started bedtime on 24th to the 26th. Felt bad for a week afterwards. Husband starting feeling same few days later. Last year I had a shot and it didn't react the same. Shot arm throbbed though, for days.									Y	10/22/2003	10/24/2003	2		PUB	OTH		NONE	NONE			1						1	Diarrhoea; Feeling abnormal; Injection site oedema; Musculoskeletal stiffness; Pain; Vomiting	FLU3~SANOFI PASTEUR~U1139AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212469	11/18/2003	MA	33.0	33		F	11/10/2003	11/9/03 12 AM left arm swelled up and pain down arm into hand, visible red line on arm and nausea. No temp. ER visit: given Rx for Cephalexin and sent home.				Y					Y	11/08/2003	11/09/2003	1	No lab tests done	PUB	PUB		NONE	Asthma			1						1	Cellulitis; Injection site oedema; Nausea; Pain	FLU3~SANOFI PASTEUR~U1098AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212470	11/18/2003	CO	39.0	39		F	11/08/2003	2 1/2 hours after vaccination I had a bad headache and slight fever. Took 2 Advil and felt better. 30 hours after vaccination I felt very nauseous, vomited fiercely, dry heaves, fever 101 degrees, severe dizziness, fatigue. Couldn't make it upstairs to bed. 72 hours after I vomited I still don't feel normal (3 days later).									N	11/04/2003	11/05/2003	1		PVT	UNK	Addevall					1						1	Dizziness; Fatigue; Headache; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1143AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212471	11/18/2003	OH				M	10/23/2003	25 minutes after injection, pt came to me complaining of swelling in hands. I noted lips were slightly swollen also. Pulse 88 reg, respires unlabored. Advised Benadryl 50 mg PO and ER if Sxs worse.				Y					Y	10/22/2003	10/22/2003	0		OTH	PVT		NONE				1						1	Face oedema; Oedema peripheral	FLU3~EVANS VACCINES~765875~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212472	11/18/2003	WA	6.0	6		F		Red, 8 x 2 area covering upper arm. Warm to touch. Gave Benadryl and sent to ER for further evaluation.				Y					U	11/07/2003	11/08/2003	1		OTH	UNK						1						1	Feeling hot; Injection site erythema; Injection site oedema	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0212473	11/18/2003	IL	64.0	64		M		Weakness in my legs, hard breathing, bad digestion, sleepless, constipating, anxiety, depression, swollen stomach especially by my right side where the liver and gallbladder is located. Want to let you know that in 2001, 2002 years I did not have any side effects. I don't know why I have side effects with this flu shot.									U	10/31/2003	11/03/2003	3		UNK	UNK	NONE		NONE			1						1	Anxiety; Asthenia; Constipation; Depression; Dyspepsia; Gastritis; Hyperventilation; Insomnia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212474	11/18/2003	NJ	70.0	70		F	11/10/2003	Site of vaccination became hot, red and itchy. The redness extended around arm about 4 in length and 2 in width.									Y	10/21/2003	10/21/2003	0		PVT	PVT	Neurontin	NONE	NONE			1						1	Injection site erythema; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U1097AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212475	11/18/2003	OH	71.0	71		F	11/05/2003	101.3 temp, excessive sweating, blurred vision, weakness when standing (extreme dizziness/sharp pain in front head), sick stomach, all over aches for about 30 hours. Could not stay out of bed!!!									Y	10/08/2003	10/08/2003	0		OTH	OTH	Lantus, Amaryl, Actos, Toproxil, Zestril, hydrochlorot	NONE	Diabetic, hypertension			1						1	Asthenia; Dizziness; Hyperhidrosis; Pain; Pyrexia; Stomach discomfort; Vision blurred	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212476	11/18/2003	NY	3.0	3		M	11/10/2003	Developed redness, warmth, swelling, tenderness at vaccine site 5 days after vaccination appeared consistent with cellulitis/erysipelas.				Y					U	11/03/2003	11/08/2003	5	NONE	PVT	PVT	Albuterol; Flovent; Singulair	Viral Upper Respiratory Infection	Congenital Nystagmus; Ocular Albiuisom			1						1	Cellulitis; Erysipelas; Feeling hot; Injection site erythema; Injection site oedema; Tenderness	FLU3~SANOFI PASTEUR~U1127AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212477	11/18/2003	TN	56.0	56		F	11/07/2003	Rash/Itchy entire body presented to ER on 11/01/2003.  Flu shot given 10/29/2003.  Rash appeared 10/30/2003.  Given Solunadrol 125mg (IM).  Diplenhydratine and Prednisone.  Rash resolved 11/06/2003.				Y					Y	10/29/2003	10/30/2003	1	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Rash pruritic	FLU3~EVANS VACCINES~765484~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212478	11/18/2003	MA	40.0	40		F	11/10/2003	Macupapular rash face, left arm (site of shot) and chest wall.				Y					U	11/06/2003	11/09/2003	3	NONE	PVT	PVT	Prednisone; Atarax	NONE	PCN, Sulfa			1						1	Rash macular; Rash papular	FLU3~SANOFI PASTEUR~U1102AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212479	11/18/2003	MN	57.0	57		F		Felt like she had a rush type feeling in arm then became light headed and in general didn't feel good.  Blood pressure taken 170/106 (left) sitting.  Said it would come and go in waves lasting several minutes.  Also said her arm feels disconnected from body.  11/06/2003: PC made to patient and she said by a few hours she felt well until 01:00 am then had the same feeling for about 2 hours.  Today has felt well.									Y	11/05/2003	11/05/2003	0	NONE	PUB	OTH	NONE	NONE	NONE			1						1	Blood pressure increased; Dissociation; Dizziness; Flushing	FLU3~SANOFI PASTEUR~U1092AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212480	11/18/2003	NC	68.0	68		M	11/11/2003	Left shoulder-size of baseball at injection site, very hot, red to purple and some swelling and down towards elbow.  Sore and painful.				Y					Y	11/05/2003	11/05/2003	0	Oxygen, blood pressure checked level.	PUB	OTH	Centrum Silver Vitamins; Vit K; Glucosamine	NONE	UNK			1						1	Injection site erythema; Injection site mass; Injection site oedema; Injection site pain; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0029N~2~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212481	11/18/2003	TX	61.0	61		F	11/06/2003	6 hours after injection, patient noticed sore arm by 21:00.  Arm painful to touch and swollen, edematous 1 hour later, took Tylenol, edematous and tender shoulder to elbow, soreness, swelling and aching all over for 3 days.									U	11/03/2003	11/03/2003	0	NONE	PUB	PVT	NONE	NONE	NONE			1						1	Injection site oedema; Injection site pain; Pain	FLU3~SANOFI PASTEUR~U1144AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0541M~6~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212482	11/18/2003	NY	2.8	2	.8	M	11/08/2003	24 hours after Fluzone, developed minimal redness at injection site; 36 hours after Fluzone, site redness increased 8cmx9cm, indurated/warm/itchy.  Given Zyrtec 2.5mg twice daily within 24 hours, redness decreased/swelling.  No further itching.									Y	11/06/2003	11/08/2003	2	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Feeling hot; Injection site erythema; Injection site induration; Injection site oedema; Pruritus	FLU3~SANOFI PASTEUR~U1076AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212483	11/18/2003	NE	39.0	39		F	11/12/2003	1st day post experienced generalized achiness, no temperature, no family members ill, developed diarrhea x 3 days, when reported (10-20) states has beginnings of a cold.  All other symptoms have resolved.									Y	10/14/2003	10/15/2003	1	NONE	PVT	PVT	NONE	NONE	Hayfever			1						1	Diarrhoea; Pain	FLU3~SANOFI PASTEUR~U1092AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212485	11/18/2003	MT	77.0	77		F	11/06/2003	At 13:00 (11/06/2003) noted some pain and warmth in right upper arm. By 15:00 pain was more intense and it felt hotter (to touch and within right arm as well).  Pain from top of right arm where meets shoulder to middle of forearm.  No loss of feeling or tingling noted. 11/06/2003 @ 16:00: RN Advised patient to apply cold compress, and repeat hourly if she notes improvement from compresses; take per mouth dose Benadryl now, and Ibuprofen/Advil in 1 hour.  Can call this RN At home (# given).  With questions or concerns or call MD/ER if symptoms worsen.  Patient to call health department in AM to update condition.  11/07/2003: Patient called.  Arm remains sore not worse, no redness or swelling.  Will report.  11/10/2003: Patient reports no arm soreness to touch or with movement, no erythema or edema.  RN advised not to take Pneumococcal shot in future and that RN would submit this report as an adverse reaction to the vaccine.									Y	11/06/2003	11/06/2003	0	NONE	PUB	OTH	Niacin 500mg per mouth 4 times a day; Y2gr thyroid per mouth 4 times a day; Tagameter or Pepcid for reflux	NONE	High cholesterol; Decreased thyroid; Reflux			1						1	Feeling hot; Injection site warmth; Pain	FLU3~SANOFI PASTEUR~U1143AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~094N~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212486	11/18/2003	SC	58.0	58		F	11/12/2003	11/04 @ 11:00: Td and Influenza.  Sore couple of hours later (hurt when given).  No treatment but moved arm.  All symptoms went away by 11/09.  Symptoms were gone.  Symptoms returned 11/11.  Very sore to touch, got worst.  No redness, but pink at site of injection.  Difficulty lifting right arm, no swelling, no fever.									U	11/04/2003	11/04/2003	0	NONE	PUB	OTH	Depakote; Evesta; Vitamins E,B,C, Multiple vitamins	NONE	NONE			1						1	Hypokinesia; Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U1260AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0833AA~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0212487	11/18/2003	NC	55.0	55		F		Pneumovax given in right arm in AM.  Patient came back approximately 25 hours with redness, swelling, tenderness and itching to deltoid muscle.  Patient seen by MD.				Y					U	10/31/2003	10/31/2003	0	NONE	PVT	OTH	NONE	NONE	Codeine, Naprosin, Glaucoma, Hypertension			1						1	Injection site erythema; Injection site oedema; Pruritus; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0257N~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212488	11/18/2003	MI	70.0	70		F	10/29/2003	10/29/2003: Walking in to health department, states 1 week after flu shot given experiencing thru today, upset stomach with burping/acid like reflex and bad taste in mouth.  Also left hip hurting (had to see chiropractor).  Feels like something is in my throat and states had same complaints last year after flu shot.  Normal sought medical evaluation.  Had breast cancer 20 years ago-currently under gone for epigastric problems with MD.  Denies derm soreness or redness in site or fatigue.									U	10/16/2003	10/23/2003	7	Referred to PMD for evaluation.  Note: Had eyebrowns (tattoo-permanent coloring to eyebrows) touched up 09/2003 and 10/28/2003.	PUB	OTH	Blood pressure; GI meds	NONE	Esophagus problems; High blood pressure, Allergy to milk (drinks soy products)		MI2003057	1						1	Dysgeusia; Eructation; Stomach discomfort	FLU3~SANOFI PASTEUR~U1287AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212489	11/18/2003	NY		21		F	11/13/2003	Redness, swelling, warmth, pain.									Y	11/11/2003	11/12/2003	1	NONE	PVT	PVT	BCP's	NONE	NONE			1						1	Feeling hot; Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U1264AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~0947N~1~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0212490	11/18/2003	PA	83.0	83		M	11/14/2003	Called physician-symptoms-runny nose, sore throat and hoarseness.  No treatment, recovered.									Y	11/03/2003	11/06/2003	3	NONE	OTH	PUB	NONE	NONE	NONE			1						1	Dysphonia; Pharyngolaryngeal pain; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1088A~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212491	11/18/2003	GA	65.0	65		F	11/11/2003	Within 24 hours of the vaccine, patient developed a fever that went up to 102 and body aches that lasted for one week.									Y	10/14/2003	10/15/2003	1	NONE	PVT	PVT	Glucophate; Aetos; Lipitor; Zoloft; Darvocet Nico; Furoremide; Klor; Sotalol HCC;	NONE	Diabetes Type 2; Hypertension; Hyperlipidemia; Anxiety, Depression, Arthritis			1						1	Pain; Pyrexia	FLU3~EVANS VACCINES~765486~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212492	11/18/2003	VA	68.0	68		F	11/13/2003	Approximately 6 hours after receiving influenza and pneumococcal vaccine; patient became severaly nauseated with chilling and increased heart rate.  Later in evening, chills alternated with burning up.  Appetite decreased and remains poor.  Symptoms lasted 3 days.				Y					Y	11/04/2003	11/04/2003	0	NONE	PUB	OTH	NONE	NONE	Codeine allergy; Hypertension			1						1	Chills; Decreased appetite; Heart rate increased; Nausea; Pyrexia	FLU3~EVANS VACCINES~765852~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0869N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212493	11/18/2003	PA	40.0	40		F	11/07/2003	Patient initially noted soreness at injection site (left arm) one-half hour later she noted numbness from the elbow to the fingers of the left arm.  Patient states this feels like carpal tunnel syndrome feels.  Patient took ibuprofen per mouth, applied ice to injection site.  Patient states that by 15:00 all numbness has resolved.   Patient states injection site still remains sore.									Y	11/06/2003	11/06/2003	0	NONE	OTH	OTH	Lidine at bedtime; Orthotricyclen	NONE	Seasonal allergies; right carpal tunnel			1						1	Hypoaesthesia; Injection site pain	FLU3~SANOFI PASTEUR~U1268AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212494	11/18/2003	FL	39.0	38		F	11/10/2003	Right arm-painful and swollen at site became itchy white and hard.  Later that evening pain and swelling spread to shoulder and beneath arm-as swelling progressed arm became redder and redder and more painful.  Till she came into clinic.  Lymph nodes swollen.  Received antibiotic Keflex, Medrol on 11/10/2003.  Client doing well.									Y	11/06/2003	11/06/2003	0	NONE	PUB	PVT	Premarin	NONE	Grasses, trees, pets, mold, chronic obstructive pulmonary disease			1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site pain; Pruritus	FLU3~SANOFI PASTEUR~U1075AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0029N~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212495	11/18/2003	SC	1.3	1	.3	M	11/17/2003	Child with birth asphyxia and history of questionable previoius seizure with no abnormalities on previous EEG.  Had fever of 101 possible unilakial seizure 2 days after administration of above vaccines.  Child also has history of recurrent high fevers without previous febrile seizure. The medical record received on 3/23/04 states staring, jerking of arm, and shivering.				Y					Y	11/11/2003	11/13/2003	2	EEG done 11/17/2003, gallium scan 11/18/2003. EEG normal (hx of abnormal MRI).	PVT	PVT	Augmentin	11/06/2003: Sinusitis-symptoms resolved at visit	Birth asphyxia, adverse reaction to tegretol; atypical movement; GERD; hyperactive airway disease; failure to thrive; feeding difficulties			1						1	Chills; Convulsion; Dyskinesia; Pyrexia; Stupor	FLU3~SANOFI PASTEUR~U1253AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0283M~3~IM~RL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0512N~1~SC~LL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|VARCEL~MERCK & CO. INC.~0195N~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0212496	11/18/2003	IL	68.0	68		F	11/17/2003	Symptoms experienced immediately after I have the flu: weakness, could barely walk, fever, lethargy, chills, nausea, pain.				Y					N	11/12/2003	11/12/2003	0		UNK	UNK	Thyroid		Cerebral spinal fluid leak; hypothyroid			1						1	Asthenia; Chills; Difficulty in walking; Lethargy; Nausea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1256AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212526	11/18/2003	PA	38.0	38		M	11/17/2003	Noticed numbness and stabbing pain at injection site and around the site. Over the next 24-36 hours, there was pain when anything came in contact with the arm. On 11/14/03, after being grabbed by co-worker in such a manner that his arm came in contact with co-worker's chest, the deltoid region proximal to shoulder from approximate injection site with numbness. No loss of sensation below injection site or fingers.									U	10/27/2003	10/27/2003	0	Forwarded to urgent care under Will Call.	PUB	PUB	Denies	No/denies	No/denies		VA03025	1						1	Hypoaesthesia; Pain	FLU3~EVANS VACCINES~765753~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212655	11/18/2003	KY	53.0	53		F	11/18/2003	Red rash, hives, itching all over entire body. Going to take benedryl liquid and use benedryl creme. We are given the Flu shot free for state workers.									Y	11/17/2003	11/17/2003	0		PUB	PUB	synthroid, celebrex, femhrt	sinusitis/ear infection				1						1	Pruritus; Rash; Urticaria	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0212656	11/18/2003	UT	2.0	2	.5	M	11/18/2003	moderate leg swelling, redness				Y					Y	11/03/2003	11/06/2003	3	None performed	MIL	MIL	TYLENOL	NO	NONE			1						1	Erythema; Swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~601A2~UNK~IM~UN~DTAP (INFANRIX)~1|FLU3~EVANS VACCINES~765754~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~770A2~UNK~IM~UN~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0212658	11/18/2003	MD	5.0	5		M	11/18/2003	2 days after vaccination, vaccinee had profuse rhinorrhea that lasted approximately 3 days. Vaccinee also had conjunctival injection. No fever was noted.  3 days after vaccination, father had prostration without fever or rhinorrhea which lasted 24 hours. 4 days after vaccination, mother had prostration without fever or rhinorrhea which lasted 24 hours.									Y	10/22/2003	10/24/2003	2		PVT	PVT	Flovent, Singulair	None	Mild asthma			1						1	Prostration; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0212659	11/18/2003	IL	72.0	72		F	11/18/2003	Pt. reported swelling, erythema, palpitations.				Y					Y	10/27/2003	10/27/2003	0	Observation based, no specific tests, no hospitalization. Pt. treated with ibuprofen and diphenhydramine per MD.	PUB	UNK	-N/A-	-N/A-	-N/A-			1						1	Erythema; Palpitations; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0772N~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212660	11/18/2003	SC	63.0	63		M	11/18/2003	Became lightheaded in pm after receiving flu vaccine in am.  Experienced light headedness and dizziness on Wednesday, Thursday, and Friday.  had B/P checked on friday: 116/82 sitting and 110/84 standing.									Y	11/03/2003	11/03/2003	0		UNK	PUB	Vitamin D, Cholesterol medications, Benadryl HS	NONE	NONE		SC0347	1						1	Dizziness	FLU3~SANOFI PASTEUR~U1260AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212661	11/18/2003	OH	40.0	40		F	11/18/2003	Upper left arm sore; at time soreness increases and thumb feels numb. Nee to take ES Tylenol 2 tabs to help relieve soreness.  Have had to get up at night to take Tylenol due to unable to sleep due to soreness.									U	10/29/2003	11/07/2003	9	None	PUB	PVT		none	none			1						1	Hypoaesthesia; Insomnia; Pain	FLU3~EVANS VACCINES~765877~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212662	11/18/2003	FL	79.0	79		F	11/18/2003	Received flu vaccine on 10/18/2003. Developed severe joint pains in ankles, knees, hips, wrists, elbos and shoulders on 10/19/2003.  Seen by physican and treated with Vioxx 12.5 mg qd.  Reported to the on 11/13/2003.  Contacted clinic and requested vaccine and site information.  Clinic has not returned request for information.				Y					N	10/18/2003	10/19/2003	1	n/a	UNK	UNK		None	None			1						1	Arthralgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0212663	11/18/2003	IL	57.0	72		M	11/18/2003	Pt reported erythema, swelling, arm weakness and numbness.				Y					Y	10/08/2003	10/08/2003	0	Observation based. Md prescribed PO steroid = resolution of symptoms.	PVT	UNK	-N/A-	-N/A-	-N/A-			1						1	Erythema; Hypoaesthesia; Muscular weakness; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0029N~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212664	11/18/2003	SC	77.0	77		M	11/18/2003	Received vaccinations at Health Department at 10:00 am on 10/23/03.  Began having left shoulder pain at 8:00 pm on 10/23/03, radiating down left arm.  Pain became worse during the night and the next day was unable to move arm. Noted swelling and redness of left shoulder.  went to doctor at 12:45 pm on 10/24/03.  Was sent to orthopedic surgeon and the MD drew fluid off left shoulder.  Was admitted to hospital on 10/24/03. Aspirated more fluid from left shoulder on 10/26/03.				Y	Y	4			Y	10/23/2003	10/23/2003	0	Blood sugars; complete blood count, synovial fluid cultures; blood cultures; chemistry panel; sed rate medical records include abnormal lab tests, hyperglycemia. msv	UNK	PUB	Avandia, Relafen, Alphogen	NONE	Asthma, type II DM, glaucoma, CA of prostate		SC0348	1						1	Aspiration; Erythema; Hyperglycaemia; Laboratory test abnormal; Shoulder pain; Swelling	FLU3~SANOFI PASTEUR~U1260AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0735M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0212665	11/18/2003	IL	71.0	71		F	11/18/2003	Pt. reported swelling & erythema. Pt was seen in the ER- no hospitalization.  Tx'ed with Keflex & Bactroban and instructed to elevate extremity. Follow up on 11/26/03: Rt arm affected-completed resolved.				Y					Y	10/07/2003	10/07/2003	0	Observation based, no specific tests performed.	PVT	UNK	-N/A-	-N/A-	-N/A-			1						1	Erythema; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0029N~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212666	11/18/2003	NJ	29.0	29		F	11/18/2003	Redness, swelling, raised area that extends from below elbow to shoulder. Achy feeling all over and tiredness.									Y	11/15/2003	11/15/2003	0		MIL	MIL	none	none	none			1						1	Erythema; Fatigue; Oedema peripheral; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~UNK~IM~RA~MENINGOCOCCAL (NO BRAND NAME)~1	USA		Influenza
0212667	11/18/2003	IL	73.0	73		F	11/18/2003	Pt. reported swelling, erythema, tenderness. Was seen by MD- recommended diphenhydramine @HS and cool compress. No hospitalization.				Y					Y	10/19/2003	10/19/2003	0	Observation based, no specific tests	PVT	UNK	-N/A-	-N/A-	-N/A-			1						1	Erythema; Swelling; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0772N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212670	11/18/2003	OH	43.0	42		F	11/18/2003	Developed pain L shoulder radiating down L arm to hand immediately following administration.  Pain persists L deltoid region despite use of Ibuprofen.  Has pain with elevation and abduction of L shoulder.  Tenderness persists at injection site which is somewhat proximal to the main body of the deltoid. Initiating physical therapy and Celebrex.									U	10/28/2003	10/28/2003	0		PVT	PVT	synthroid	none	thyroid disease			1						1	Injection site pain; Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~u1269aa~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212672	11/18/2003	NH	24.0	24		M	11/18/2003	POST VACCINATION DAY #8 PATIENT WAS HOSPITALIZED 15NOV2003  AT HOSPITAL WITH FEVER, SWELLING IN LEFT ARM, GENERAL MALAISE, AFTER SUCCESSFUL VACCINATION. PATIENT WAS DISCHARGED ON 18NOV2003. PATIENT STATES ONE LARGE ULCER ON THE LEFT DELTOID.				Y	Y	3			Y	11/07/2003	11/15/2003	8	ALL BLOOD WORK AND SPINAL TAP VALUES WERE NEGATIVE	MIL	MIL	NONE	NONE	Heart burn, acne rash			1						1	Malaise; Pyrexia; Skin ulcer; Swelling	FLU3~SANOFI PASTEUR~U1271AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020071~1~ID~LA~SMALLPOX (DRYVAX)~1	USA	Hospitalisation	Influenza
0212673	11/18/2003	AZ	52.0	52		M	11/18/2003	app 2-3 weeks after vacc, developed strong flu-like symptoms, after two weeks with no improvement, went to Doctor and diagnosed with pneumonia.  Medicated - antibiotic, 2 inhalers, cough syruo w/ coedine				Y					N	10/04/2003	10/15/2003	11	blood tests, cxr	UNK	PVT	OTC COLD/FLU	NONE	NONE			1						1	Influenza like illness; Pneumonia	FLU3~SANOFI PASTEUR~41090aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0257N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212676	11/18/2003	TN	40.0	40		F	11/18/2003	Pt called to report that she was experiencing, hives, a rash all over.  This rash started on Sunday, 11/16/03, twelve days post vaccine administration.  Pt states no other possible environmental factors, or lifestyle changes that might has caused this rash, she is sure that it is from the influenza vaccine.  Pt has taken the vaccine before w/o adverse effects & related no know allergies to us.  She reports that she has an app't to see her MD today.  This nurse requested pt to stop by the Health Dept. while she was in town today so I could see the rash she is experiencing, but she did not return to the office.  Outcome of MD visit unknown.				Y					U	11/04/2003	11/16/2003	12		PUB	PUB	unknown	None related to public health nurse	none known			1						1	Rash; Urticaria	FLU3~EVANS VACCINES~765980~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212680	11/18/2003	MI	77.0	77		F	11/18/2003	Had flu shot on 11-14-03 and next morning while getting out of bed felt real dizzy. Went away but periodically felt thru the day and next few days lightly.									Y	11/14/2003				UNK	UNK						1						1	Dizziness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212682	11/18/2003	OR	72.0	73		F	11/18/2003	Fatigue, and echimosis in left elbow, down to hand.  (Vaccine injected into Right arm IM.)  Pt. was not seen by doctor until 11/17/2003.  Vital signs at time of Dr. Visit BP 144/70, T 97.0, P 84, R no info.				Y					Y	11/04/2003	11/07/2003	3	CBC, PT/PTT, CMP	PUB	PUB	Ogen, Xana, Celexa, Klonipin, Triamcinolone, Nexium, Vit. B-12, Centrum Silver.	Pt denies illness at time of vaccination.	Fatigue, depression, hypothyroidism, headache.  The drug, Lipitor, has caused simular bleeding in the past.			1						1	Blood pressure increased; Ecchymosis; Fatigue	FLU3~SANOFI PASTEUR~u1260aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212028	11/19/2003	TX	61.0	61		U		Within 12 hours-had fever, cough, headache, chills, sore throat with blisters, missed 4 days work. Do not get dressed for 5 days. Doctor's visit. Not completely.				Y					N	11/05/2003	11/06/2003	1		OTH	OTH			Some food allergies			1						2	Chills; Dysphagia; Ear pain; Headache; Joint range of motion decreased; Pain; Pharyngolaryngeal pain; Pruritus; Pyrexia; Blister; Chills; Cough; Headache; Pharyngolaryngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0212546	11/19/2003	CA	58.0			F	11/07/2003	58 year old female with previous history of flu vaccination, developed severe pain and ecchymosis from site of injection from right arm to upper portion of arm (above elbow starting 5 hours after injection). The pain was severe requiring treatment with Vicodin. After 20 days, pain subsided, but ecchymosis still present.								Y	U	10/20/2003	10/20/2003	0	NONE	UNK	UNK			End state renal disease; No known allergies; Had flu shots in the past without problems.			1						1	Injection site haemorrhage; Injection site pain	FLU3~EVANS VACCINES~765799~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0212547	11/19/2003	NJ	37.0	37		M	11/10/2003	Guillain-Barre syndrome with motor and sensory deficit.			Y		Y			Y	U	11/07/2001	04/01/2002	145	EMG decreased in nerve conduction.	UNK	UNK	NONE		NONE			1						1	Guillain-Barre syndrome; Hypokinesia; Sensory disturbance	FLU3~SANOFI PASTEUR~U0696BA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0212552	11/19/2003	NC	62.0	62		F		Pt given .5ml flu vaccine left deltoid. Had received flu vaccine in past without problems. Went shopping with spouse. About 1 hour after vaccine was given, per husband, pt became very flushed and began to itch all over. Drove pt back to base to ER. No shortness of breath, wheezing or airway problems observed. (See attached)				Y					Y	10/31/2003	10/31/2003	0		OTH	MIL		Rheumatoid arthritis, acid reflux			NC03133	1						1	Flushing; Pruritus	FLU3~SANOFI PASTEUR~U1147AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212553	11/19/2003	OH	38.0	38		F	11/18/2003	1st flu vaccine for this pt. Was given in AM. Pt developed dizziness, lightheadedness, and increase of BP. When seen in my office in mid afternoon BP was still 160/98. Pt was observed and monitored in office until BP returned to normal.				Y					Y	11/12/2003	11/12/2003	0		UNK	UNK		NONE	Hypertension controlled by med			1						1	Blood pressure increased; Dizziness	FLU3~SANOFI PASTEUR~U1076AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212554	11/19/2003	NY	80.0	79		M	11/17/2003	Patient who is health center employee received Fluzone on 10/2/03 to left deltoid. He experienced some discomfort following injection (mild). Approximately 7-10 days later, he developed vesicular lesions in dermatomal distribution consistent with a shingles outbreak. Rash reported to nursing department on 10/27/03.				Y					Y	10/02/2003	10/10/2003	8		PUB	PUB	Medical for urine control.	NONE	NONE			1						1	Discomfort; Herpes zoster; Rash vesicular; Skin ulcer; Viral infection	FLU3~SANOFI PASTEUR~U1271AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212555	11/19/2003	CA	71.0	71		F		Feeling well when she got her flu shot. 24 hours later, had fever to 102, profound fatigue, non-productive cough. No myalgias, rhinorrhea, headache. ESR done 10/17/03 (18); repeat one week later (87). Considered to be reactivation of polymyalgia.									U	10/17/2003	10/18/2003	1	ESR	PVT	UNK		NONE	Polymyalgia			1						1	Condition aggravated; Cough; Fatigue; Pyrexia	FLU3~SANOFI PASTEUR~U1122AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212556	11/19/2003	NC	67.0	67		M	11/06/2003	Nausea, diarrhea 2 hours after administration of vaccine. Tiredness, chills, nausea and diarrhea for 48 to 72 hours.									Y	10/29/2003	10/29/2003	0	NONE	PUB	UNK	Synthroid; Clonazepam	NONE	Thyroid condition; Restless legs		NC03132	1						1	Chills; Diarrhoea; Fatigue; Nausea	FLU3~SANOFI PASTEUR~U1123AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212557	11/19/2003	NC	66.0	66		F	11/06/2003	Sore throat, fever 100, chills, body aches, weakness for 48 to 72 hours.									Y	10/23/2003	10/24/2003	1	NONE	PUB	PUB	Methotrexate; Synthroid; HCTZ; Leukovorin	NONE	Inflammatory Rheumatoid Arthritis		NC03131	1						1	Asthenia; Chills; Pain; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U1123AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212558	11/19/2003	TX	71.0	71		M	11/01/2003	Was vaccinated 10/11/03. 36 hours later had fever of 101.01; called ER at hospital and nurse said spit not colored; he has virus and to give Tylenol every 4 hours. Called nurse 2 times daily. Pulmonary doctor Monday, Tuesday, and Wednesday and they all said the same (virus). Wednesday night, fever 103.1, lost 10 pounds, weak and could not get out of bed. Had pneumonia and in hospital for 8 days. The hospital discharge summary received on 1/13/04 states dyspnea. 60-day follow up on 01/29/04: Pt has recovered from adverse events.					Y				N	10/11/2003	10/12/2003	1		PUB	UNK	mevacor, Livisom, Digoxin, ASA, Huma bid, Advair	Severe emphysema	Emphysema, heart attack 1987, aortic aneurysm 2000			1						1	Dyspnoea; Pneumonia; Pyrexia; Viral infection; Weight decreased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0212560	11/19/2003	UT	51.0	51		F	11/06/2003	Shot administered at 1:40 PM. RN approached patient about 15 minutes later to inquire about how she was feeling. At that time patient stated she felt shaky and that immediately following the shot, she felt a warm flash in her chest. Patient was given 8mg of Chlorpheniramine at 1:58 PM and a sucker. 1:50 PM, BP 132/90, 2:30 120/84. Patient stated she felt better and would be able to drive herself home. Patient released about 2:40 to return home.									Y	11/06/2003	11/06/2003	0		PUB	UNK		NONE	Hay fever			1						1	Hot flush; Tremor	FLU3~SANOFI PASTEUR~U1256AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212561	11/19/2003	UT	30.0	30		F	11/12/2003	Patient received flu shot for 1st time. Answered no to all screening questions. 10 minutes after vaccine, she was itching on face, legs, arms and chest. Redness on left eyebrow, chin and chest. Stated no respiratory symptoms. She was given 2 tabs (4mg each) of chlorpheniramine.									U	11/12/2003	11/12/2003	0	NONE	PUB	OTH	NONE	NONE	PCN			1						1	Erythema; Pruritus	FLU3~EVANS VACCINES~765704~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212562	11/19/2003	UT	28.0	28		F	10/22/2003	Immediate bruise at injection; rash/redness around area within 15 minutes. Patient complaining of joint aching.									Y	10/22/2003	10/23/2003	1	US nl	OTH	UNK		NONE	NONE			1						1	Arthralgia; Contusion; Erythema; Injection site rash	FLU3~EVANS VACCINES~765704~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212563	11/19/2003	TN	46.0	46		F	11/13/2003	Patient experienced pain at the time of injection. Increasing discomfort and decreasing mobility everyday since. Some swelling in the area; no redness. Unable to lift arm against gravity.									Y	11/07/2003	11/07/2003	0	NONE	PVT	PVT	Ambien; Astelin; Avinza; Estrace; Reglan; Tagamet; Lexapin; Lisinopril; Lorcet; Phenergan	Hypertension; Reynaud's Syndrome	Calcium channel blockers; Beta blockers; Naproxen			1						1	Discomfort; Hypokinesia; Injection site swelling; Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~U1079AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212565	11/19/2003	MI	13.0	13		F	11/06/2003	Received Fluzone 11/4/03. On 11/6/03 developed Bell's Palsy with right facial droop. The medical records received on 1/12/04 states talking funny, droop of mouth, and rt sided facial paralysis.				Y					U	11/04/2003	11/06/2003	2		PVT	PVT	NONE	NONE	NONE			1						1	Facial palsy; Speech disorder	FLU3~SANOFI PASTEUR~VO1088AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212566	11/19/2003	IL		48		F	11/10/2003	Raised rash upper left arm with lots of pain; warm and tender to touch.									Y	11/06/2003	11/07/2003	1	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Injection site pain; Injection site rash; Injection site warmth	FLU3~SANOFI PASTEUR~U1253AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0819M~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212567	11/19/2003	CA	4.0	3		F	11/10/2003	Per parents, soon after vaccine administration, patient had blisters (3) around injection site and approximately 3-4cm2 area of redness for several days.									Y	10/02/2003	10/02/2003	0	NONE	PVT	PVT	NONE	NONE	History of asthma	Cyanosis, discoloration of thigh~Pneumo (Prevnar)~1~0.00~In Patient		1						1	Blister; Injection site erythema	FLU3~SANOFI PASTEUR~U1136AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212568	11/19/2003	TX	70.0	70		F	11/07/2003	Patient reports that arm had red patch of erythema that evening from shoulder to elbow. Today (day 2) arm is swollen, red, warm to touch and painful.									U	11/06/2003	11/06/2003	0		PUB	PUB		NONE	NONE			1						1	Erythema; Feeling hot; Pain; Swelling	FLU3~SANOFI PASTEUR~U1091AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0256N~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212570	11/19/2003	NY	34.0	34		F	11/04/2003	Wheezing, very congested in chest area, hard to take a full breath. Pale in color approximately 4.5 hours following the vaccine.									Y	10/24/2003	10/24/2003	0		PUB	OTH		NONE	NONE			1						1	Dyspnoea; Nasal congestion; Pallor; Wheezing	FLU3~EVANS VACCINES~765874~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212571	11/19/2003	NY		28		F	11/11/2003	Developed generalized hives 6-7 hours after the influenza vaccine. Had to see nurse practitioner; given Kenalog shot and Prednisone and Benedryl. Studies done by nurse practitioner.				Y					Y	10/31/2003	10/31/2003	0	CBC; Mono test; Liver function test all negative.	PVT	PVT	BCP	NONE	Codeine			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1132AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212572	11/19/2003	WI	48.0	48		F	11/10/2003	In 24 to 48 hours, temperature 103, weakness, fatigue. Used Tylenol; temp to 101.5 after Tylenol.									Y	11/07/2003	11/08/2003	1	NONE	PVT	PVT		NONE	Penicillin; Tetracycline; GERD; Skin issues			1						1	Asthenia; Fatigue; Pyrexia	FLU3~SANOFI PASTEUR~U1136AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212573	11/19/2003	IA	4.0	4		F	11/10/2003	Vaccine given 10/30/03. Mom noticed hives on 11/1/03 and 11/2/03. Hives were gone by 11/3/03. Mom states may have had hives on Friday 10/31; doesn't know since was with dad that day.									Y	10/30/2003	11/01/2003	2	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1080AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212574	11/19/2003	AR	31.0			F	11/11/2003	Received flu vaccine on 10/21/03 2PM. Noted some discomfort 10/22/03 about 5:30PM to injection site. Noted to be red and indurated at site and was swollen.									Y	10/21/2003	10/22/2003	1	NONE	MIL	PVT	NONE	NONE	Pollen allergies			1						1	Discomfort; Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U1075AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212575	11/19/2003	CA	44.0	44		F	11/10/2003	5x7cm area of redness which is tender to touch-no treatment done.				Y					U	11/07/2003	11/09/2003	2	NONE	PVT	UNK	NONE	NONE	NONE			1						1	Erythema; Tenderness	FLU3~EVANS VACCINES~765978~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212576	11/19/2003	TX	42.0	42		M	11/10/2003	Pt exhibited signs of a panic attack, sweating, dizziness, coldness. Pt has history of panic attacks symptoms subsided after 20 minutes.				Y					Y	11/10/2003	11/10/2003	0	Blood pressure taken 138/68	OTH	OTH	Paxil	NONE	Panic attacks			1						1	Dizziness; Feeling cold; Hyperhidrosis; Panic reaction	FLU3~SANOFI PASTEUR~1254AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212577	11/19/2003	NY	40.0	40		F	11/13/2003	C/O nausea, light headedness approx. 20 min after flu shot. 2:30p BP 128/88, 2:50p BP 124/84-given cookies and juice. 3:25p feeling much better.									Y	11/12/2003	11/12/2003	0	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Blood pressure increased; Dizziness; Nausea	FLU3~EVANS VACCINES~765710~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212578	11/19/2003	NC	36.0	42		F	11/10/2003	Pt experienced local reaction post pneumonia shot to R arm redness et induration approx 6cm by 20cm increased warmth, temp increased 101 deg, increased soreness to touch.									Y	11/05/2003	11/05/2003	0		PUB	PVT	NONE	NONE	Allergy to Compezine-dystonic reaction			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site reaction; Injection site warmth; Pyrexia	FLU3~EVANS VACCINES~765196~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0068N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212579	11/19/2003	NC	58.0	53		F	11/14/2003	5x7cm-reddened area (+) deltoid with induration < .5cm increased warmth et tenderness at site. Advised to apply warm compresses et report to MD of worsened.									U	11/13/2003	11/14/2003	1	NONE	PUB	PVT	Lipitor, Zoloft, Zyrtec, HCTZ	NONE	Seasonal allergies, HTN, high cholesterol, thyroid			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site warmth	FLU3~EVANS VACCINES~765196~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212580	11/19/2003	CA	63.0	63		M	11/13/2003	Chills, fever, pain in back and both legs, headache, loss of balance, it lasted 24 hrs.				Y					Y	10/28/2003	10/29/2003	1	Blood work inclosed	OTH	PUB		NONE	Spinal cord damage C4-C5.			1						1	Back pain; Balance disorder; Chills; Headache; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212581	11/19/2003	CA	65.0	65		F	11/18/2003	Site of injection began itching rather intensely within 10 min of administration. A six-inch oval real of raised, redness developed within 24 hrs. Hot to the touch. Remained reddened from 10/24/02 until approx 11/19/02. Never had a fever nor any respiratory symptom.  Follow up on 12/03/03: nothing answered.									Y	10/24/2002	10/24/2002	0		PVT	OTH	Premarin, Actonel, Famotidine		Osteoporosis, GERD			1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Injection site warmth; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212582	11/19/2003	FL	24.0	24		F	11/03/2003	Nausea and vomiting within 1 hr of shot-went home from work slept and nurse called next day-pt stated she was fine.									Y	11/03/2003	11/03/2003	0	NONE	OTH	OTH	NONE		NONE			1						1	Nausea; Vomiting	FLU3~SANOFI PASTEUR~U1087AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212583	11/19/2003	AZ	24.0	24		M	11/10/2003	C/O's feeling flushed, dizzy 20 minutes after receiving flu shot. (+) face, neck flushing four hrs later. Dizziness four hrs later. V.S.S. no SOB. Tx: Benadryl 50mg po q 6 hrs s/s lasted 24 hrs.									Y	11/02/2003	11/02/2003	0	NONE	OTH	OTH	Allegra	NONE	Allergies-ragweed (seasonal and some foods)			1						1	Dizziness; Flushing	FLU3~EVANS VACCINES~765855~4~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212585	11/19/2003	CT	1.06	1	.1	F	11/13/2003	Ataxia starting within 30 minutes of vaccine administration. Difficulty standing up unsteady gait, frequent falling down. Pt improving. Cough developed after vaccine.									U	11/12/2003	11/12/2003	0		PVT	PVT	PPD	Runny nose-cough developed after vaccine	RAD Medical records state exzema. msv			1						1	Coordination abnormal; Cough; Fall; Gait disturbance	FLU3~SANOFI PASTEUR~U1270AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0577N~1~SC~~VARICELLA (VARIVAX)~1	USA		Influenza
0212586	11/19/2003	OR	73.0	76		F	11/11/2003	Received flu shot 10/22/03. 10/23/03 I broke out in hives all over my body. ARm swollen and red at the site of injection size of orange. Continued to get worse. 10/24/03 soon Dr put me on Viotaril. 10/28/03 clinic Prednisone and Zyrtec. No new spots 10/31/03. 11/11/03 still blotchy and peeling. Follow up on 12/10/2003: 									Y	10/22/2003	10/23/2003	1	NONE	PVT	UNK	Atenolol, Diovan, teranosin, Lipitor, Paxil	NONE	PCN, sulfa, morphine			1						1	Injection site erythema; Injection site oedema; Rash macular; Skin exfoliation; Urticaria	FLU3~SANOFI PASTEUR~U1093AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212587	11/19/2003	GA	15.0	15		M	11/14/2003	On 10/14/03 pt began having acute double vision. The morning after receiving injection awakened with eye, slightly swollen and red which resolved post 12 hrs. Did not report double vision to parents until 10/22/03. At this time they made appt with opthamalogist who comfirmed dx of diplopia. Continue to have double vision and has follow up appt 12/10/03 with neuro opthamalogist. The medical record received on 2/3/04 states double vision.									N	10/09/2003	10/10/2003	1	MRI was done 10/24/03 with other testing which was negative.	PUB	UNK	NONE	NONE	Myopia Medical records state pneumonia, fever, cough, asthenia, headache. msv			1						1	Diplopia; Eye oedema; Ocular hyperaemia	FLU3~EVANS VACCINES~765707~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212588	11/19/2003	CA	64.0	64		M	11/13/2003	Flu shot 10/24/03 flu symptom 10/27 fever, cough, etc. FEver 1 day cough 1 wk. Flu shot in 2002-no r/u but cough/cold followed. Flu shot in 2001-no r/u but cough/cold followed. Follow up on 12/03/03: you will have to get this info from the pharmacist wher ethe vaccine was administered.									Y	10/24/2003	10/27/2003	3		OTH	PVT	Lisinopril			Cough/cold followed~Influenza (Seasonal) (no brand name)~~63.00~In Patient		1						1	Cough; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212589	11/19/2003	WA	32.0	32		F	11/13/2003	5cm x 3.5cm erythematous non pruritic, slightly raised slightly tender and warm to touch, dry rreaction over vaccination site. Appeared within 24 hrs post injection. No systemic signs or symptoms found/noted. Other vaccinations from same vial without incident.									Y	11/12/2003	11/13/2003	1		OTH	UNK	Generic Lo Estrin	NONE	NONE			1						1	Erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~EVANS VACCINES~765496~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212590	11/19/2003	PA	37.0	36		F	11/06/2003	Generalized hives beginning about 12 hrs after injection. Injection site slightly hyperemic but no swelling. Lasted 4 days.									Y	11/05/2003	11/06/2003	1	NONE	OTH	PVT		NONE	Mushrooms, PCN			1						1	Hyperaemia; Urticaria	FLU3~EVANS VACCINES~765851~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212591	11/19/2003	MT	2.7	2	.7	M		Pt had a grand mal seizure, lasting 4-5 mins, according to mother. Was taken to ER had CBC and CT scan of head (both wnl)-then saw neurologist on 10/23/03 and EEG done (also wnl). No further work-up or follow-up recommended unless pt has another seizure. The medical records received on 1/21/04 states lethargy, and bite tongue.				Y					Y	10/16/2003	10/19/2003	3	CBC, CT scan, EEG all reported wnl by mother;Labs abnormal.	PVT	PVT	NONE	NONE	NONE			1						1	Convulsion; Glossitis; Laboratory test abnormal; Lethargy	FLU3~SANOFI PASTEUR~U1099AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212592	11/19/2003	GA	59.0	59		M	10/21/2003	Nausea, loss of appetite, fever, chills, dizziness.									Y	10/13/2003	10/14/2003	1		PUB	UNK	Glucotrol, Actos, Synthroid, Paxil	NONE	Reg meds only-diabetes, hypothyroid, hypertension			1						1	Anorexia; Chills; Dizziness; Nausea; Pyrexia	FLU3~EVANS VACCINES~765137~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212593	11/19/2003	WA	32.0	32		F	10/22/2003	Pt reports she had symptoms of congestion, sneezing and fatigue on 10/19/03 prior to vaccination. Vaccinated with flu and Pneumovax on left deltoid at 3pm on 10/20/03. Continued to have more fatigue, arm pain and cold symptoms 10/21/03 she was in bed, not feeling well, fever of 102 deg F with Tylenol. 10/22/03 fatigue and myalgia and red warm arm at vaccination site. 10/23/03 pt seen and treated with antibiotics for infection. Resolved by 10/29/03.				Y					Y	10/20/2003	10/21/2003	1		PUB	UNK		Cold s/s-sneezing, congestion, fatigue				1						1	Condition aggravated; Fatigue; Infection; Injection site erythema; Injection site warmth; Malaise; Myalgia; Pain; Pharyngitis; Pyrexia; Rhinitis	FLU3~EVANS VACCINES~76579~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0820M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212594	11/19/2003	WA	6.0	6		F	11/05/2003	Red, warm, swollen R deltoid, measuring 2 in diameter. Temp of 99 deg with Tylenol. Swelling in axilla. AH symptoms began 10/22/03j am and ended by 10/24/03 am.									Y	10/20/2003	10/22/2003	2		PUB	PUB		NONE				1						1	Erythema; Feeling hot; Oedema peripheral; Pyrexia	FLU3~SANOFI PASTEUR~U1122AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0820M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212596	11/19/2003	UT	36.0	36		F	11/11/2003	Pt noticed burning left arm following vaccination with pneumonia. This increased by the next day to burning in chest and neck to left ear. She was advised to contact MD and subsequently went to ER Tx'd with Epinephrine, steroids x1 week. Noted difficulty breathing when weaned off, steroids restarted and continued Tx until 11/6/03.				Y					Y	10/15/2003	10/16/2003	1		OTH	PVT	UNK	NONE	UNK			1						1	Chest pain; Neck pain; Skin burning sensation	FLU3~EVANS VACCINES~765670~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0445M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212597	11/19/2003	UT	45.0	45		F	11/07/2003	Approx 30 minutes after receiving injection had tingling from top of her head to bottom of her feet, and broke out in a rash and became itchy. 8mg chlorpheniramine PO given and v/s taken. Within 10-15 minutes symptoms decreased, only tingling remained in head.									Y	11/07/2003	11/07/2003	0		OTH	OTH	Anti-depressant, vitamins	NONE	NONE			1						1	Paraesthesia; Pruritus; Rash	FLU3~SANOFI PASTEUR~U1256AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212598	11/19/2003	GA	23.0	23		F	11/12/2003	Received 2nd dose Varivax and influenza vaccine in left arm on 11/6/03. On 11/11/03 developed mild pruritic rash on neck. Today is diffuse pruritic allergic fine rash on arms, neck, chest and back. Tx: Allegra and Zyrtec.									U	11/06/2003	11/11/2003	5		PVT	PVT		NONE	NONE	localized rxn~Varicella (Varivax)~1~23.00~In Patient		1						1	Rash pruritic	FLU3~SANOFI PASTEUR~U1134BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0548N~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0212599	11/19/2003	GA	77.0	77		F	10/20/2003	Received flu shot 10/15/03 left arm, started hurting by lunch, with small amount of bruising at injection site. By 10/16/03 left arm down to elbow was blue and purple, with pain upon movement. Went to ER Sat AM 10/18/03. ER MD advised her to lift arm and apply heat or ice. She said that heat made it hurt worse so she would apply ice and raise arm. Gave her percocet for pain. Went to NP 10/20/03. Advised to lift and apply ice.				Y					N	10/15/2003	10/15/2003	0	Not done	PUB	PUB	Tambicor, Cardizem, Remeron, Lorcet Plus, Coumadin	NKA	Stroke, HTN			1						1	Contusion; Joint range of motion decreased; Pain	FLU3~EVANS VACCINES~765704~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212600	11/19/2003	NY	36.0	36		F	10/23/2003	Noticed hives - neck/arm/legs about 30 minutes after vaccination. Benadryl OTC 50mg 6PM, resolves 24 hours later, no trouble breathing. Irritation, left arm ache - resolved.									Y	10/22/2003	10/22/2003	0	NONE	PUB	PVT	Allegra, weekly allergy shots	NONE	Multiple drug (Keflex, sulfa, Albuterol, codeine) and environmental allergies			1						1	Pain; Skin irritation; Urticaria	FLU3~EVANS VACCINES~765705~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212601	11/19/2003	MA	38.0	38		F	11/10/2003	36-48 hours after dose given, T up to 100.4, 4 raised red/hot to touch lesion, hives on upper torso. Resolved with Benadryl. Occurred on 11/7/03. Did not seek medical attention. Flu vaccine received.									Y	11/05/2003	11/07/2003	2	NONE	PUB	UNK		NONE	Hypothyroidism, hx: eczema, Hashimoto's syndrome			1						1	Injection site warmth; Pyrexia; Rash erythematous; Skin ulcer; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212603	11/19/2003	NE	72.0	72		M	11/13/2003	6 x 6 red raised area, hot, hurts to touch right deltoid.									U	11/10/2003	11/10/2003	0		PVT	PVT		NONE	NONE			1						1	Injection site oedema; Injection site warmth; Pain; Rash erythematous	FLU3~EVANS VACCINES~765956~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0986N~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212609	11/19/2003	OH	68.0	68		F	11/12/2003	3 hours after the vaccination I thought the room looked strange and started fainting over and over. This was real bad. Went to hospital, sat in waiting room. Went to my Dr next day and heart Dr in day or 2. (Fainted for 4 days). BS 120, BP 120/70, P 68. Started Icmeclizine 25 mg 1 at 3 a day the next day, manager told me not to take it that day.				Y					U	10/28/2003	10/28/2003	0		PUB	UNK	Insulin, IC Propranolol, Avapro, IC Famotidine, Bumex, IC potassium		Allergies: sulfa, iodine dye, penicillin. Diabetic, heart COPD, CHF kidney, stent in heart			1						1	Syncope	FLU3~SANOFI PASTEUR~U1270AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212642	11/19/2003	CA	4.0	4		M	11/13/2003	Erythema, warmth enlarging around area of injection left deltoid since given 11/11.				Y					U	11/11/2003	11/11/2003	0	NONE	PVT	PUB	NONE	NONE	Morbid obesity			1						1	Feeling hot; Injection site erythema	DTAP~GLAXOSMITHKLINE BIOLOGICALS~616A2~UNK~IM~LA~DTAP (INFANRIX)~1|FLU3~EVANS VACCINES~765143~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|MMR~MERCK & CO. INC.~0100~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0212646	11/19/2003	NC	68.0	68		F	11/10/2003	Right deltoid muscle-pain at injection site extending down arm to wrist-painful nodule 3x3cm at site with warmth-pt developed symptoms later that day after injection.									U	10/27/2003	10/27/2003	0	NONE	PUB	PUB	NONE	NONE	NONE		NC03134	1						1	Injection site nodule; Injection site pain; Injection site warmth	FLU3~EVANS VACCINES~765704~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~SANOFI PASTEUR~U0831AA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0212651	11/19/2003					F		A report was received from a health care professional on 11/7/03 concerning a female vaccinee in her early 20's who experienced pins and needles in her arm, followed by total arm numbness 13 days after vaccination, and was hospitalized an unspecified length of time after receiving Flurvirin on 10/14/03. On 10/27/03, the vaccinee began to experience pins and needles in her arm, followed by total arm numbness. Soon thereafter the vaccinee was hospitazlized on an unspecified date and diagnosed with myelitis. The reporter did not have a personal medical history for the vaccinee. The vaccinee had not recovered at the time of the report and remains hospitalized. There was insufficient information to determine the reporter's causality assessment. Follow up pending.					Y				N	10/14/2003	10/27/2003	13		UNK	UNK	NONE				PJP200301021	1						1	Hypoaesthesia; Myelitis; Paraesthesia	FLU3~EVANS VACCINES~765878~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0212683	11/19/2003	CA	3.0	3		F	11/18/2003	High fever of 102.5 occured seven hours after shot was given. Fever of 100-102.5 occured over next 24 hours. Body aches, paleness and fast heart beat.  Child had no appetite and very little thirst. Child was extremely fatigued and seemed delirious at times.  Tylenol was given at times throughout the day to reduce fever.									N	11/17/2003	11/17/2003	0		UNK	UNK		none	none			1						1	Anorexia; Delirium; Fatigue; Heart rate increased; Pain; Pallor; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212684	11/19/2003	MA	43.0	43		M	10/29/2003	Flu like symptoms, fever, chills, lethargy. Still sick.									N	10/02/2003	10/05/2003	3		OTH	OTH	Valtrex	NONE	PCN allergy			1						1	Chills; Influenza like illness; Lethargy; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0212729	11/19/2003	PA	67.0	67		M	11/19/2003	Flu vaccination: Nov 3, 4 p.m. Symptom: Fainted and fell from chair to the right side on Nov 5, 10 a.m.									Y	11/03/2003	11/05/2003	2	Nov 3: checked pulse rate. Nov 4: EKG showed heart beat rate of 56 instead of anormal of 70 Nov 7: Carotid sonogram, Echo Cardiogram, Holter Monitor (24 hrs) Result: Normal	UNK	PUB	None	None	None			1						1	Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212735	11/19/2003	NV	74.0	74		F	11/19/2003	Patient c/o excessive soreness in left shoulder joint beginning 1 week after injection and persisting to date. Most painful with forward mvmt vs. lateral lifting. Patient states she has impaired muscle movement.									U	10/15/2003	10/22/2003	7	none	PUB	PVT			Pt. states she has 2 valves that leak. She has regular echocardiograms to monitor for changes and takes proph. antibiotics prior to dental work.  Pt. did have tendonitis years ago in that shoulder, but claims this muscle pain is different.			1						1	Hypokinesia; Shoulder pain	FLU3~SANOFI PASTEUR~U1142AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212738	11/19/2003	OR	79.0	79		M	11/19/2003	Pt developed rash, puritis, redness, swelling in left deltoid (injection site) five days after injection				Y					Y	11/04/2003	11/09/2003	5	CBC, Chem 12, (CK< Tryponin T to rule out cardiac)	PUB	PUB	Vasotec, Indapamide, Zantac, Protonix, Nitrostat SL.	Pt denied illness at time of vaccination.	None noted by his doctor			1						1	Injection site erythema; Injection site swelling; Pruritus; Rash	FLU3~SANOFI PASTEUR~U1260AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212739	11/19/2003	NC	24.0	24		M	11/19/2003	10/07/03- received smallpox vaccine along with 8 other vaccines 10/20/03 (02:00)- developed chest pain and shortness of breath 10/20/03 (06:00)- was taken to ER- EKG (? result not available at this time)-elevated cardiac enzyme studies- normal CXR- blood pressure elevated 10/22/03- discharged in stable condition- given prescription for antihypertensive meds 10/24/03- chest pain reappeared- 6-7x/d and each episode lasted 1-1 ½ hours- occurs suddenly without any aggravating factors- alleviated by resting- also c/o sob on mild exertion 11/12/03- went to ER for insomnia- also c/o fatigue and lack of energy (d/t insomnia), mild transient dizziness and mild depression- no change in intensity/frequency of cp- bp still elevated- EKG ST changes but improving- cardiac enzyme studies and CXR normal- bp med dosage increased- given ambien- scheduled for weekly assessment at a clinic for bp check and continued evaluation of sx- f/u with Cardiology in 2 wks scheduled. A copy of the patient's clinical summary sent to VAERS via FedEx on 11/19/03. Clinical summary states myo-pericarditis.				Y	Y	3			N	10/07/2003	10/20/2003	13	3.LABS: 03/03/02  Chol: 165 (140-200)  10/20/03 (0721) CK-MB: 10.1 (2.3-9.5) Relative Index: 4.7 (0-2.5) MB: 13.9 (0-5) CK: 213 (22-269) Troponin: 3.24 (0-1.5)  10/20/03 (1310) CK-MB: 27.8 (2.3-9.5) Relative Index: 4.5 (0-2.5) MB: 45.70 (0-5) CK: 612 (22-269) Troponin: 20.62 (0-1.5)  10/22/03 (0615) CK-MB: 4.3 (2.3-9.5) CK: 153 (22-269) Troponin: 3.26 (0-1.5)  11/12/03 (0946) CK: 94 (22-269) Troponin: <0.07 (0-1.5)  DIAGNOSTIC TESTS: 10/20/03 EKG- result unknown- no copy of the EKG report available at this time CXR- portable AP; no gross abnormalities  11/7/03 MUGA scan; the ventricles are grossly normal in size, and there is normal left ventricular wall motion.  The left ventricular ejection fraction is 56% Impression; normal LV function  11/12/03 CXR- AP and Lat; normal EKG-ST changes but improving (according to pt's clinician's note)- no copy of   the EKG report available at this time	MIL	UNK	None	None	Asthma- childhood- moderate- now gone			1						1	Blood pressure increased; Chest pain; Depression; Dizziness; Dyspnoea; Fatigue; Insomnia; Laboratory test abnormal; Myocarditis; Pericarditis	ANTH~MICHIGAN DEPT PUB HLTH~FAV075~2~~RA~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~1~~~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~1~~~HEP A (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~1~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~1~~LA~SMALLPOX (DRYVAX)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0212741	11/19/2003	FL	64.0	64		F	11/19/2003	Fever, pain at injection site (left arm) Dull headache, Throat raw and swollen, fatigue, erythema, edema, limited ROM. Dx:  Cellulitis Left Upper arm, Prob allergy to Pnuemonia Vaccine.  Tx:  Decadron 8mg IM,  Rocephin 500 IM, Augmentation XR 1000 BIDX10 days,  Mederol Dose pak.				Y					U	11/17/2003	11/18/2003	1		PVT	PUB	B complexProtonix Celexa Synthroid Thazadone Pravachol Estradial Tiam/Hctz ASA 81mg Plavix 75mg Exelon 6mg Alprazolam .5 Patanol Opth  1% Aleve Centrum vits.	Recovering from bilateral upper lobe pneumonia, sepsis, septic shock, COPD, bilateral bronchiectasis.	Albuteral,   Beta Blockers			1						1	Cellulitis; Erythema; Fatigue; Headache; Injection site pain; Joint range of motion decreased; Oedema; Pharyngolaryngeal pain; Pyrexia	FLU3~EVANS VACCINES~765409~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0988N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212742	11/19/2003	IN	39.0	38		M	11/19/2003	Began with numbness in lower left arm, tingly left side of face, dizziness with blurred vision.  I had severe migrane headaches that evening at the hospital.  I was completely fine before the shot.  I have never had migrane headaches before.  I underwent several tests to find a reason and none of the findings could explain why I was having these symptoms. The medical record received on 12/23/03 states lightheadedness. The medical record received on 3/23/04 states photophobia and nausea.				Y	Y	1			Y	11/05/2003	11/06/2003	1	MRI - Head and neck Xray - Chest Ultrasound - coroughted arteries (neck) CT scan - head Lumbar puncture - tested for menengitius Bloodpatch for Lumbar Puncture - to close leak from original LP.	UNK	UNK	Glucophage XR 500mg Amaryl 4mg Prilosec 20 mg		Type II diabetes,G.E.R.D.,Hypertension, depression, sleep apnea			1						1	Dizziness; Hypoaesthesia; Migraine; Nausea; Paraesthesia; Photophobia; Vision blurred	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0212743	11/19/2003	VA	40.0	40		F	11/19/2003	Pt awoke approximately 13 hours after administration with difficulty beathing.  Felt as if something was blocking her airway. After taking po Benedryl, patient drove herself to the ER, . O2 SAT =90.  Pt was given steroid injection and steroid nebulizer.  Pt states that the diagnosis was Pharangitis and edema of the uvula.  Pt was d/c'd home and recovered within 3 days. The ER summary received on 1/12/04 states difficulty swallowing, sore throat, edema of uvula and anxiety.				Y					Y	11/14/2003	11/15/2003	1	o2 SAT on admission to ER was 90%	UNK	PVT	unknown	none	Asthma, osteoarthritis.			1						1	Anxiety; Dysphagia; Dyspnoea; Oedema; Pharyngitis; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~u1077AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212744	11/19/2003	MO	43.0	43		F	11/19/2003	Angry, Red, raised area, hot to touch 2.5 inches by 1.5 inches, painful  treated with ice, tyenol, benedryl if needed									Y	11/18/2003	11/18/2003	0		PUB	PVT	Arthrotec	no	Lupus  Rhuematoid Arthritis			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~EVANS VACCINES~765880~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212745	11/19/2003	AL	52.0	52		F	11/19/2003	Flu shot administered on 11/13/03, woke up on 11/14/03 approx. 7 a.m. could not get any air into lungs. gasping for air. Husband call 911, went to hospital in ambulance.  ER administered shot, and breathing treatments. Gave me two prescriptions: Prednisone 20mg 1,3x's a day (Q-15) and Doxycycl 100 mg 1, 2x's a day (Q-20).  If symptons persist follow up with Dr.				Y					Y	11/13/2003	11/14/2003	1	COPD, emphysema	PUB	UNK	Ms Contin, Neurontin, Synthroid, Nexium	None	Penicyllin, injected iodine			1						1	Dyspnoea; Emphysema; Lung disorder	FLUX~UNKNOWN MANUFACTURER~Unknown~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0212746	11/19/2003	NY	5.0	39		F	11/19/2003	After a flu shot, I develope a alergic reaction (skin rash)on my right arm (shot was given on this arm)around my abdomen and my back, also some in my legs.The flu shot was given to me at 10:45 am and the alergic reaction start around 3:00pm when my body start to itch, by 6:00pm I took 2 capsule of Benadryl and also apply Benadryl cream on my skin.After an hour and a half the redness on my skin starting to go away.I will check with my doctor tomorrow.									U	11/19/2003	11/19/2003	0	none	PUB	PVT	none	none	none			1						1	Erythema; Hypersensitivity; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212268	11/20/2003	TN	75.0	75		F	11/17/2003	From initial information received on 11/13/03 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 75 year old female patient received a dose of FLUZONE SV 2003-2004 USP, lot number U1253AA, administered IM in the left deltoid on 11/4/03 at 11:05 AM. Approximately 15 minutes later, the patient's husband stated that he could not wake her up. The patient was not verbally responsive and her skin was cold and clammy. Her pupils dilated. The patient's blood pressure was 80/50. She was given 0.3cc of Epinephrine, after which she vomited approximately 1500cc coffee ground emesis. The patient was placed on a stretcher and a cool cloth was applied to her head. Her blood pressure was now 90/70 and pulse at 88. The pupils returned to normal state and the patient became verbally responsive. Emergency health services were present at 11:30. The patient recovered from these events. From additional information received on 19/Feb/2004 from a health care professional, it was reported that no additional information is available at this time. No further information is anticipated, this case is considered closed. The reporter of this case is the same reporter of case 2003-02987. Follow up 01/06/05:Medical Assessment: IN the absence of another atiology the hypothesis of either an allergic like reaction or a vasovagal syncope could be evoked. However, there were no allerty tests reported and the heart rate, or pulse, at the time of the event is unknown.				Y					Y	11/04/2003	11/04/2003	0	BP 80/50 and later 90/70; Pulse 88.	PUB	UNK					200302988	1						2	Cold sweat; Coma; Depressed level of consciousness; Mydriasis; Vomiting; Blood pressure decreased; Cold sweat; Coma; Depressed level of consciousness; Mydriasis; Vomiting	FLU3~SANOFI PASTEUR~U1253AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1253AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0212685	11/20/2003	TX	61.0	61		M	03/05/2004	Information has been received from a health professional and a physician concerning a 61 year old male with a history of coronary bypass surgery who on 9/30/03 was vaccinated with a dose of penumococcal 23v polysaccharide vaccine (645246/0029N). Concomitant therapy included influenza virus vaccine and Coumadin. For several days after the vaccine the pt had a fever and chills. On 10/8/03 the pt was brought to the ER with chills, sweats and a fever. The report indicated that they did tests. It was also reported that he had a chest x-ray and CBC and was given an injection of Rocephin and Phenergan. He was diagnosed with mild renal failure. He was discharged with a prescription for Keflex and went home. The next day, on 10/9/03, the pt died of pneumonia. The reporter expressed a concern with the lot. There was no product quality complaint involved. Pneumonia was considered to be immediately life-threatening and disabling. Additional info has been requested.  The autopsy report states septic endocarditis. Follow up on 12/04/03: The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Follow up information from a physician and medical records indicated that the pt had open heart surgery on 23Dec2002 which consisted of one by-pass and a valve replacement. It was reported that the operation went well and the pt had a remarkable recovery. He first had a heart murmur which felt to be benign. He followed up with his primary who ordered an echodardiogram and the problem with his heart valve was discovered. He was sent for a cardiac cathaterization and they recommended immediate replacement of his aortic valve together with a repair of the aneurysm. On 30Sep2003 the pt was seen by a physician and reported to be in good health, and would probably live to be 100. His physical exam was negative at that time. That day he received te pneumococcal 23v polysaccharide vaccine and the influenza virus vaccine. On 02Oct2003 the pt had his monthly labwork done for a a warfarin sodium level. The result was 3.3 and he was instructed to stay on the same dose. On 04Oct2003 the pt was feeling a bit under a the weather, was coughing and did not act up to par. On 05Oct2003 the pt felt the same way, but he had a slight cough and was hoarse. By 07Oct2003 the pt began to run a temperature of 103 and was having uncontrollable chills, sweating, vomiting and diarrhea. The symptoms were only temporary and he took acetaminophen which broke the fever. He had a good appetite and was eating three meals a day. On 08Oct2003 the pt felt good, but had a bout with uncontrollable chills and reported that he was so cold he couldn't get warm. He took two acetaminophen and felt better, but later had the sweating, vomiting and diarrhea.  At 8:30PM he was again having uncontrollable chills and the lobes of his ears looked blue. He was not running a temperature. He was seen in the ER and was told he had symptoms of pneumonia. His temperature was normal and his blood pressure was a little low. He was told by a physician that this was because he was sick. A chest x-ray and bloodwork were done and were reported to be normal, however his blood sugar was 184. He was told that this may make him a little confused. His wife reported that he was confused after taking it. It was reported that the doctor also ordered an injection of something for nausea and an injection of an antibiotic. The pt's wife was assured by the nurse that these medications would not interact with anything the pt was currently taking. He was given IV to replace body fluids since his blood presure was low. While he was on the IV he had to go to the bathroom with diarrhea and vomiting. It was reported that he was very weak and almost fell off the commode. The pt was released from the ER with a diagnosis of a viral infection and was given prescriptions for dicyclomin hydrochloride 10mg capsule, cephalexia 500mg capsule and diphen/atrop 2.5mg tablet. It was reported that he rested well that night, but did a lot of night sweating. He felt better than the day before, but was still experiencing diarrhea and vomiting. ON 09Oct03 at 7:37AM the pt's blood pressure was 91-56-117 and his temperature was 96. He tried to eat and drink and his blood pressure at 8:25 was up to 101-54-112. The pt indicated that he would be ok so his wife left the house. She found him at 10:30AM sitting on the floor. He had gotten up to go to the bathroom, but felt sick so he sat there to vomit in the trash can. His wife put him in bed, he took his medications and drank some water and reported that his throat burned. At 10:41AM his blood pressure was 80-44-68 and his nails were blue so the pt's wife called 911. The pt reported that his neck hurt, so his wife removed pillows and the pt turned his head and stopped breathing. The wife started CPR. With no reponse after a few minutes, she ran out and screamed to a neighbor. The neighbors gave CPR until the ambulence arrived. The pt was taken to the ER where the family was told the pt passed away. An autopsy was performed and the cause of death was listed as septic paravalvular leak due to dehiscence of prosthetic aortic valve due to prosthetic valve endocarditis with ring abscess. The death was reported as natural.  Pneumonia, sepsis, endocarditis, abscess and leakage were considered to be immediately life-threatening and disabling.  Additional information is not expected.	Y	10/09/2003	Y	Y				Y	N	09/30/2003	10/08/2003	8	Blood pressure 10/8/03, little low, Blood pressure, 10/9/03, 91 7:37AM, Blood pressure, 10/9/03, 101 8:25AM,  Diagnostic laboratory, 10/8/03 normal,  Chest x-ray 10/8/03 normal,  Blood pressure 10/09/03, 80 10:41AM.   Body temp 10/8/03 fever,  Complete blood cell 10/8/03 unknown. INR, 06/23/03, 2.3 Prothrombin time, 06/23/03, 24.4 seonds 12.2-14.8 High Serum alanine, 05/12/03, 42U/L, 21-72 SCPT Serum creatinine, 05/12/03, 1.0mg/dL, 0.5-1.5 Serum cholesterol/HDL-C, 05/12/2003, 2.9, 1.7-6.7 Low Serum cholesterol, 5/12/03, 150mg/dL, 120-200 Serum chloride, 05/12/03, 103mmol, 98-110 Serum calcium, 05/12/03, 9.4mg/dL, 8.4-10.2 Serum blood urea, 05/12/03, 15mg/dL, 9-20 Serum aspartate, 05/12/03, 37U/L, 15-46, GOT Serum alkaline, 05/12/03, 92U/L, 38-126 Serum albumin, 05/12/03, 3.7g/dL, 3.6-5.0 Total serum protein, 05/12/02, 7.2g/dL, 6.3-8.2 Total serum carbon, 05/12/03, 30mmol, 22-32 Total serum bilirubin, 05/12/03, 0.8mg/dL, 0.2-1.3 Temperature measurement, 10/9/03, 96, 7:37AM Serum VLDL-C, 05/12/03, 11mg/dL, 5-51 Serum triglyceride, 05/12/03, 55mg/dL, 40-160 Serum sodium, 05/12/03, 137mmol, 137-145 Serum prostate specific, 05/12/03, 1.66ng/mL, 0.0-4.0 Serum potassium, 05/12/03, 4.4mmol, 3.5-5.3 Serum LDL-C calculated, 05/12,03, 87mg/dL, 0-135 Serum HDL-C, 05/12/03, 52mg/dL, 30-90 Serum glucose, 05/12/03, 85mg/dL, 75-115 Serum glucose, 05/12/03, 85mg/dL, 75-110 PT control, 06/23/2003, 13.5 second Serum direct bilirubin, 05/12/03, 0.1mg/dL, 0.0-0.5 Body temp, 10/08/2003, afebrile; normal Body temp, 10/07/03, 103 Blood drug screen, 10/02/03, 3.3, Coumadin level Body temp, 10/08/03, fever Blood glucose, 10/08/03, 104	PVT	PVT	Coumadin Lipito aspirin acetaminophen		Coronary bypass surgery; Aortic valve replacement; Lumbar vertebral fracture; Aortic aneurysm; Cardiac murmur; Haemorrhoids; Smoker; Iodine allergy; Hyperlipidaemia; social alcohol drinker; hearing loss		WAES0311USA00578	1						1	Abscess; Apnoea; Cardiac valve disease; Chills; Confusional state; Cough; Cyanosis; Diarrhoea; Endocarditis; Hyperhidrosis; Neck pain; Pharyngolaryngeal pain; Pneumonia; Pyrexia; Renal failure; Vomiting	FLU3~SANOFI PASTEUR~~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~5452460029N~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Results in Death	Influenza
0212695	11/20/2003	OH	73.0	72		M	11/17/2003	From initial information received on 11/14/03 from a health care professional regarding an adverse events occurring in the USA, it was reported that a 72 year old male patient received a Fluzone SV 2003-2004 USP vaccination, lot number U1126AA, administered IM on 10/20/03 at 10:00AM. Three days later on 10/23/03 at 6:00 AM, the patient developed suspected myocarditis with congestive heart failure, atrioventricular block and cardiomegaly. The recovery status of the patient is unknown. No other information was reported.  Follow up on 09/29/04 states: Despite continued attempts to obtain follow-up, no further information was provided. No further information is anticipated, this case is considered closed.					Y	5			U	10/20/2003	10/23/2003	3	Serology for Influenza A/B and Coxsackie A/B: no results provided.	PVT	OTH	Aspirin; Lipitor; Lasix; Ambien; Humulijn	NONE	NONE		200303014	1						1	Atrioventricular block; Cardiac failure congestive; Cardiomegaly; Myocarditis	FLU3~SANOFI PASTEUR~U1126AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0212699	11/20/2003	MI	49.0	49		F	10/27/2003	Localized reaction to flu vaccine at site of injection-discoloration, edema, soreness extending under the arm. Treatment: ice packs prn, Benadryl 50mgm q 4-6 hrs prn.				Y					Y	10/21/2003	10/22/2003	1		OTH	OTH	NONE	NONE	NONE			1						1	Injection site oedema; Injection site pain; Skin discolouration	FLU3~SANOFI PASTEUR~U1081AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212700	11/20/2003	LA	0.5	0	.5	M	11/17/2003	11/8/03 Went to ER 9:15 AM with fever, bulging fontanel, vomiting came  after Tylenol and/or Motrin. Admitted for 1 day. 11/13/03 In doctors office; states swelling to head had gone down but now swollen face and temperature of 99.5. 11/13/03 To ER (temperature 105), fever and otitis media. 11/14/03 Saw doctor and admitted to hospital; fever 105 for 3 days (positive influenza A on 11/14/03). The discharge summary received on 12/24/03 states influenza A.				Y	Y	4			Y	11/07/2003	11/08/2003	1	Positive influenza A on 11/14/03.	PVT	PUB	Reglan; Zantac; Benedryl; Tylenol	Faint, red rash under arm; lower abdominal and upper legs by groin.	Reflux			1						1	Face oedema; Fontanelle bulging; Laboratory test abnormal; Otitis media; Pyrexia; Viral infection; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~21895A2~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1108AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UA861AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~493269~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0212701	11/20/2003	OK	36.0	36		M	11/14/2003	Guillain-Barre Syndrome following influenza vaccine.					Y				U	10/21/2003	10/24/2003	3		MIL	MIL	NONE	NONE	NONE			1						1	Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0212702	11/20/2003	PA	75.0	75		M	11/18/2003	Left arm numbness, then L leg numbness, foot felt heavy and could not lift foot. L shoulder and neck muscles tight and sore to area under L ear. Blood pressure elevated to 170/90.				Y					U	11/05/2003	11/17/2003	12	CT head negative	PVT	PVT			PCN			1						1	Blood pressure increased; Hypoaesthesia; Musculoskeletal stiffness; Sensation of heaviness; Tenderness	FLU3~SANOFI PASTEUR~U1089AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212703	11/20/2003	NC	72.0	72		M		Rash on inside of each arm at elbow. At injection point-cyst (pussed, than scabbed over) (noted that nurse had never seen a cyst like this one before).									Y	11/05/2003	11/06/2003	1		OTH	PVT			Psoriasis, arthritis			1						1	Injection site cyst; Rash	FLU3~EVANS VACCINES~765795~7+~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212704	11/20/2003	AL	0.5	0	.5	F	11/19/2003	Th pt received vaccines on 11/14/03 at 0935. On 11/15/03 developed fever of 101, which continued until 11/17/03 then went to 103 that morning. The pt was irritable and continued to have fever until 11/18/03. The pt was seen in our office on 11/17/03 and 11/18/03.				Y					Y	11/14/2003	11/15/2003	1	CBC-normal limits.	PVT	PVT	Albuterol inhalation solution, Pulmicort respules, Vigamox opitol drops		Asthma, dacryostenosis			1						1	Irritability; Pyrexia	DTAP~SANOFI PASTEUR~C1606AA~3~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1267AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~VE028AA~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~493476~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0212705	11/20/2003	AL				U		Dizzy and off balance for 2 days, 1st day worst than 2nd day.									Y	11/05/2003	11/06/2003	1	Normal	PUB	OTH	Bextra, potassium, Lasix, ferrous	NONE	NONE			1						1	Balance disorder; Dizziness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212706	11/20/2003	VA	38.0	38		F	11/12/2003	Client called 11/12/03 and stated after receiving flu vaccine on 11/10/03 took two reg strength Tylenol and went home about 5:30pm, c/o having tingling-numb like feeling from upper lip to chest that lasted approx 45 min.									Y	11/10/2003	11/10/2003	0	NONE	PUB	PVT	NONE	NONE	Allergy to Monistat and sulfa			1						1	Hypoaesthesia; Paraesthesia	FLU3~EVANS VACCINES~765753~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212707	11/20/2003	CA	77.0	77		F	10/28/2003	Shot 9:45am 10/18 Sat. Monday 10/20 am-onset of cold/flu symptoms. Pm-feeling worse. Tuesday-no food, drank one glass of water. Midday threw up immediately. Wed-midday-1 pc to as T. Thursday-feeling better but runny nose and sore throat and continue symptoms continue Friday, Sat, Sun, Mon-begin to feel better after six days. But nasal cong. continues.									Y	10/18/2003	10/20/2003	2		PUB	UNK		NONE	PCN-anaphylactic shock, burns on thighs for several months.			1						1	Decreased appetite; Influenza like illness; Nasal congestion; Pharyngitis; Pharyngolaryngeal pain; Rhinitis; Rhinorrhoea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212708	11/20/2003	NY	54.0	54		M	11/13/2003	Pt diagnosed with Bell's palsy facial weakness left side of the face corticosteroids, maisbuy ey drops neurology f/u.				Y					N	10/09/2003	11/06/2003	28		PVT	UNK	Glucophage, Gyburid, Enalapril	Flu like symptom	DM			1						1	Facial palsy	FLU3~SANOFI PASTEUR~U1088AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212709	11/20/2003	NY	80.0	80		F	11/11/2003	Became light headed, weak, shaking, flushed with rapid heart rate 3 hr 45 min after receiving flu shot.									Y	11/09/2003	11/09/2003	0	NONE	OTH	PVT	Thyroid, Atenolol, Captapril, Actosal, vitamins	NONE	Arthritis, rapid heart beat			1						1	Asthenia; Dizziness; Flushing; Heart rate increased; Tremor	FLU3~EVANS VACCINES~765959~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212710	11/20/2003	NY	65.0	65		F	11/11/2003	Immediately after receiving injection felt light headed and arm ached-15-20 min after injection continued c/o feel faint vital signs within normal limits. Rested and to car-felt faint-not diaphoretic but heart rate elevated transported to emergency dept.				Y					Y	11/03/2003	11/03/2003	0	EKG, chest x-ray, blood work-IV Benadryl.	OTH	PVT	Cardizem, Plaxil, Lipitor, Plavid	NONE	Coro bypass surgery in 2002.			1						1	Dizziness; Heart rate increased; Pain	FLU3~EVANS VACCINES~765959~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212725	11/20/2003	ME	0.1	0	.8	U	11/11/2003	1st dose of fluzone 3 days after shot onset of pruritis for 1 hour, lethargy and fever 100-103 for 2 days.  2nd dose onset 4 days later similar onset and fever but also needed meds for cough and congestion.  Follow up on 01/12/04: Mom would like you to call.  PT was seen on friday screaming for 1/2 hour and then went limp.  Had temp then after 24 hrs was fine.  Then other 2 bros/sist got it and now another bro has it.  She would like to talk to you for just a minute.  Called mom.  3rd child now about to come down with same syndrome - 24 hour fever and fussiness. Doubt from imm.									Y	10/07/2003	10/10/2003	3	NONE	PVT	PUB	NONE	NONE	Asthma			1						1	Cough; Lethargy; Nasal congestion; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~U1088AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212726	11/20/2003	ME	0.1	0	.8	U	11/10/2003	1st dose of fluzone 3 days after shot onset of pruritis for 1 hour, lethargy and fever 100-103 for 2 days.  2nd dose onset 4 days later similar onset and fever but also needed meds for cough and congestion. Follow up on 01/12/04: The triplets did the same thing 4 days after this flu shot.  Belly pain, then screaming, then limp and sleeping and temp.  Mom insists that you call her.  Talked with mom, with first dose of fluzone, the triplets sequentially developed (at 1 day intervals) beginning 3 days after 1) screeching for an hour 2) lethargy 3) fever 100-103 that lasted 2-3 days.  Second dose onset 4 days after.  All three at once.  Similar onset and fevers, but this time also needing some nebs for coughing and congestion.									Y	10/07/2003	10/10/2003	3	NONE	PVT	PUB	NONE	NONE	Asthma			1						1	Cough; Lethargy; Nasal congestion; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~U1088AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212727	11/20/2003	ME	0.76	0	.8	U	11/10/2003	1st dose of fluzone 3 days after shot onset of pruritic for 1 hour, lethargy and fever 1001-03 for 2 days.  2nd dose onset 4 days later similar onset and fever but also needed meds for cough and congestion. Medical records state viral infection. msv									Y	10/07/2003	10/10/2003	3	NONE	PVT	PUB	NONE	NONE	Asthma Medical records state bronchiolitis. msv			1						1	Cough; Lethargy; Nasal congestion; Pruritus; Pyrexia; Urinary tract infection	FLU3~SANOFI PASTEUR~U1088AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212748	11/20/2003	MO	67.0	67		F	11/12/2003	A hours after receiving injection paitents arm became very swollen, red and painful about 2 below where shot was given extending to elbow.  Called me at home the next day to report-advised ibuprofin and heat as swelling had decreased but still c/o pain.  I called 11-12-03 and patient said arm was much improved did not seek medical attention.									Y	11/10/2003	11/10/2003	0		PUB	PUB					MO200397	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1103AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0068N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212752	11/20/2003	IL	25.0			F	11/15/2003	Chronic urticaria since about April 2003.  (Exact date of onset not clear)				Y					N				Allergy skin test to foods, contactants and blood and urine work all was negative	MIL	MIL	NONE	NONE	NONE			1						1	Urticaria	ANTH~EMERGENT BIOSOLUTIONS~~UNK~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1|YF~UNKNOWN MANUFACTURER~~UNK~~~YELLOW FEVER (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0212756	11/20/2003	CA	63.0	63		F	11/20/2003	10/27  VACCINATION 10/30  GENERAL MALAISE FIRST FOLLOWED BY SEVERE        VOMITING. 10/31  FEVER OF 99.6. ACHINESS LOWER EXTREMITIES        JOINTS AND MUSCLES ONLY. 11/01  DISCOMFORT LEFT LEG, PRIMARILY IN LEFT         CALF 11/02  DISCOMFORT LEFT CALF AND LEFT ANKLE  11/03  INCREASING DISCOMFORT LEFT CALF AND ANKLE        SAW SPECIALIST PHYSICIAN FOR UNRELATED        MATTER.  ULTRSOUND OF LEFT LEG ORDERED. 11/04  ULTRASOUND OF LEFT LEG: UNREMARKABLE. 11/05  INCREASING PAIN, LEFT LEG, PRIMARILY        LEFT ANKLE AND CALF. 11/07  SAW FAMILY PHYSICIAN. UNABLE TO SIT, STAND        OR LIE.  WALKING ONLY RELIEF.  PAIN         SEVERE LEFT LEG HIP TO ANKLE.  MEDICATION:        BEXTRA AND SKELAXIN PRESCRIBED. 11/08  PAIN CONTINUES. UNABLE TO TURN IN BED         WITHOUT SEVERE PAIN. MEDICATION OF NO         BENEFIT. 11/10  PAIN SUBSIDING SOMEWHAT BY EVENING. 11/12  PAIN RETURNS FULL STRENTH, UNABLE TO BEND        AT HIP.  NEED ASSISTANCE TO DRESS.  WALKING        /PACING STILL ONLY RELIEF. LEFT HIP AND         CALF PRIMARILY.   11/13  PAIN SUBSIDING 11/14  SAW FAMILY PHYSICIAN. PAIN REDUCED TO         DISCOMFORT IN AFTERNOON.  11:00 PM PAIN        MOST SEVERE YET.  CONTEMPLATED TRIP TO         EMERGENCY ROOM.  TOOK A VIOCIN.  SLEPT 4        HOURS. 11/17  PAIN SUBSIDED TO ACHE LEFT HIP, TIGHTNESS        LEFT CALF. 11/18  SAME 11/19  ACHE AND CALF LESS UNCOMFORTABLE. 11/20  INTERMITTENT SLIGHT DISCOMFORT LEFT HIP.  PLEASE NOTE:  I HAD NO REACTION TO THE FIRST VACCINATION RECEIVED OCTOBER 8TH (I THINK).  SECOND VACCINATION ON OCTOBER 27TH WAS A MISTAKE ON MY PART.				Y					U	10/27/2003	10/30/2003	3	SOME BLOOD WORK DONE.  DON'T KNOW WHICH.  RESULTS UNREMARKABLE, I THINK.	PVT	UNK		NONE	POSSIBLE LUNG DISEASE			1						1	Discomfort; Malaise; Pain; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0212757	11/20/2003	NJ	73.0	73		M	11/20/2003	Weakness, cough, dehydration, muscle soreness, spiking temperatures, low blood pressure (90/50). I took the flu shot on Oct 21,2003. Vaccine manufacturer is Aventis-Pasteur Lot #U1076AA(Exp. date 6/30/04. I started experiencing symptoms listed beginning October 23. I was ordered by my physician to the emergency room on October 31,2003. I was admitted and remained in the hospital until 11/8/03. I was treated with antibiotics and steriods. Discharge summary states anemia. msv Medical recoirds state anorexia. msv					Y	3			N	10/21/2003	10/23/2003	2	Discharge summary states increased SGOT, alk Phos. msv Medical records state leukocytosis, hyponatremia, hypokalemia, abnormal lab tests. msv	UNK	UNK	None	None	None Medical records state hyperlipedemia, prostte disease. msv			1						1	Anaemia; Anorexia; Aspartate aminotransferase increased; Asthenia; Blood alkaline phosphatase increased; Blood pressure decreased; Cough; Dehydration; Hypokalaemia; Hyponatraemia; Laboratory test abnormal; Leukocytosis; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1076AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0212758	11/20/2003	MS	68.0	68		F	11/12/2003	Patient had Tetanus toxiod in right deltoid as well as flu and Pneumo in the left deltoid.  Later in the day patient experienced lump in left axilla also pain in left arm.  Today, 11/13, Left arm is discoloredeschemic and reddened area.									Y	11/10/2003	11/10/2003	0	None	PUB	PUB	None	none	none		MS03096	1						1	Erythema; Injection site mass; Injection site pain; Skin discolouration	FLU3~SANOFI PASTEUR~U1271AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1026M~2~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U1010AA~2~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0212760	11/20/2003	IL	65.0	65		M	11/20/2003	Awakened with pain and swelling on the underside of the left arm all the way down to the elbow.  Became progressively difficult to bend elbow.  The swelling progressed to the wrist and finally resolved about 5 days later with the use of tylenol and ice packs.									Y	11/03/2003	11/04/2003	1	None done	PUB	PVT	None	None	None			1						1	Joint range of motion decreased; Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~u1092AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0287N~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212761	11/20/2003	CA	38.0	38		F	11/20/2003	@ 0730 Received flu Shot   0830 Complained of arm pain (deltoid area)        Chills and diarrhea  @ 0900 light headed        pain and tingling down arm @ 0915 Taken to hospital Treatment: Received I.V. for about an hour and released.				Y					Y	11/02/2003	11/02/2003	0		MIL	MIL						1						1	Chills; Diarrhoea; Dizziness; Pain; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~765754~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0212763	11/20/2003	AZ	46.0	46		M	11/20/2003	Redness, induration, pruritic Reaction on left deltoid at site of 4th Anthrax immunization, began 1 day after vaccination. Was seen in ED, treated with Benadryl.  Redness has decreased, itching is now tolerable, induration persists.				Y					Y	11/17/2003	11/18/2003	1	None	MIL	MIL	Nortryptilline Gabapentin Oxycodeine/Hydrocodeine	Had been in hospital the week prior for removal of kidney stone.	No allergies to medications.			1						1	Injection site erythema; Injection site induration; Pruritus	ANTH~EMERGENT BIOSOLUTIONS~FAV078~4~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212764	11/20/2003	VA	32.0	32		M	11/20/2003	Local tenderness as moderate starting 1 hr after vaccine given.  At 24 hrs post-vaccination an enlarged, tender supraclavicular lymph node was palpable on the ipsilateral side.  No other nodes present at 48 hrs.  Mild myalgias, Afebrile at 48 hrs.  Patient is physician reporting- lot number can be verified at a later time.									N	11/18/2003	11/18/2003	0		MIL	UNK	None	None	NKDA, No PMH, No PFSH			1						1	Injection site pain; Lymphadenopathy; Myalgia	FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212765	11/20/2003	NJ	41.0	41		F	11/20/2003	Woke up with hives in AM, also cold like symptoms, coughing,congestion,mild dizziness									U	11/18/2003	11/19/2003	1	none	PUB	PUB		onset of cold				1						1	Cough; Dizziness; Nasal congestion; Pharyngitis; Rhinitis; Urticaria	FLUX~UNKNOWN MANUFACTURER~unknown~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212767	11/21/2003	TN	66.0	66		M		This subject is a 66 year old male who was taken to the emergency dept after collapsing in his home while enrolled in RSV11 study. The subject received his second dose of RSV vaccine or Placebo and influenza vaccine on 10/22/03. Subject collapsed at home on 11/12, 21 days post immunization. Subject's wife and stepson attempted CPR. An ambulance was called and subject was taken to the emergency dept. There was little EKG activity on arrival and subject died in the ER on 11/12/03. Cause of death was not reported. The death was reported by the investigator as not related to the study vaccine.  Follow up on 12/16/2003: Additonal information received 12/01/2003, CIF and ER report.  CIF: Cause of death-cardiac arrest w/secondary underlying cardiac disease.  Additional information received 12/03/2003.  Subject attempted to get out chair at home in the AM of 11/12/2003, and collapsed, hit a wall and landed on the cough.  EMS notified and responded.  Subject in asystole, CPR was started, IV fluids, intubated and sent to ER for further management, but remained asystole. Cause of death, cardiac arrest with secondary underlying cardiac disease.  The cardiac arrest with secondary underlying cardiac disease was assessed by the investigator as unrelated to the study vaccine.  Additonal information available with source documents. ER report	Y	11/12/2003							N	10/22/2003	11/12/2003	21	Admission: 2/19-23/2003. Reported labs were as follows: postop day one-PCV 35.9, INR 1.27, BUN 50 and creatinine 1.7. Day two INR was 2.41. Day 2: BUN 54, creatinine 1.8, PCV 34.8 and INR 2.55. Post operative day four room air sat was 93% and INR was 2.22. Admission on July 10-13/2003. Creatinine 4.0 BUN 137, potassium 5.4. Post treatment: creatinine 1.2, BUN 71.	UNK	UNK	Bumez; Zaroxolyn; Coreg; Zocor; Zestril; Bufferin; Salsalate; Doxycycline; Milk of Magnesia; Dimetapp; Albuterol, Atrovent; Zocor; Lasix; Lanoxin; K-lor; Colace; ASA; Toprol; Amoxicillin; Antivert; Hydrodiuril; Lortab; Quinine; Pepcid; Ativ		CHF, bronchitis, COPD, leg cramps, gout, acute renal failure. Information from previous hospital admissions. Admission February 19-23/2003. Subject was admitted for bilateral knee replacement 96 days post-immunization. Reported labs were as follows: postop day one-PCV 35.9, INR 1.27, BUN 50 and creatinine 1.7. Day two INR was 2.41. Day three urine output was 550cc in 8 hrs, BUN 54, creatinine 1.8, PCV 34.8 and INR 2.55. He also had 1+ pitting pedal edema. Post operative day four room air sat was 93% and INR was 2.22. Treatment post surgery included infusion of two units packed red blood cells. The subject recovered and was discharged on 2/23/03 and continued in the trial. The event of bilateral knee replacement surgery was reported by the investigator as unrelated to the study vaccine. Past medical history includes use of quad cane for ambulation, arthritis, leg cramps, gout, COPD, renal insufficiency, HTN, CHF with cardiomyopathy, hyper cholesterolemia, obesity, rotator cuff tear, back surgery and chronic bronchitis. Past radiography demonstrated advanced arthritis in both knees. Concurrent medications include Bufferin, SAlmalate, Doxycycline, milk of Magnesia, Dimetapp, Albuterol, Atrovent, Zocor, Lasix, Zestril, Lanoxin, K-Lor, Colace, ASA, Toprol, Amoxicillin, Antivert, Hydrodiuril, Lortab, Quinine, Pepcid, Ativan, Colchicine, vitamin E, One a day multi vitamin, Selenium, Lorazepam and Bextra. Admission 6/25-27-2003. Over the last two months the subject experienced intermittent severe dyspnea, peripheral edema and paroxysmal nocturnal dyspnea which became progressively worse and on 3/25/03, 223 days post immunization he was admitted to the hospital. Subject underwent a right heart catheterization on the day of admission and was found to have a right atrial pressure of 16 and a wedge pressure of 25. Subject was aggrressively diuresed with IV Lasix with symptomatic improvement and was discharged from hospital 2 days later on 6/27/03. The event was assessed by the investigator as unrelated to the study vaccine. Previous history: Diagnosed with dialated cardiomyopathy in 1992. In 1995, the ejection fraction was 15% to 25%. He underwent cardiac catheterization in February 1999, and was found to have an ejection fraction of 20% and no significant coronary disease. Over the last two years, he had intermittent severe dyspnea and peripheral edema. Admission 7/10-13/03. Subject was admitted 238 days post immunization for congestive heart failure and acute renal insufficiency. This subject had been admitted approximately two weeks prior secondary to volume overload, was diuresed and sent home on Bumex and Zaroxolyn of which the pt took both q.d. Despite previous advised to take Zaroxolyn on a prn basis per his weight. During this time he had also been on escalated doses of Neurontin for his peripheral neuropathy. Just prior to be being admitted his dose was 3600mg q.d. He presented at the clinic for evaluation with a one week history of increasing fatigue, sleepiness, increasing tremor and shakiness, difficulty walking, swelling in his feet bilaterally. It was felt he had Neurontin toxocity. Subject had his Neurontin held and neurological symptoms improved. Routine labs demonstrated that his initial creatinine was 4.0 with a BUN of 137 and a potassium of 5.4 indicating acute renal insufficiency likely secondary to volume depletion and he had become toxic on his Neurontin doses. A renal ultrasound was obtained which was normal. Post multiple 500cc fluid boluses, his renal function returned to his baseline. At the time of discharge he was reinstituted on his ACE inhabitor and beta-blocker, continued on Digoxin, Zocor and his diuretic was changed to Bumex 3mg p.d. without Zaroxolyn. He was placed on fluid restriction for his peripheral neuropathy, which he continued to complain about. He was started on Elavil at 25mg p.o q.d. Medications Bumex 2mg p.o. q.d., potassium chloride 30mEq p.o. q.d., Zestril 5mg p.o. bid, Lanoxin 0.25mg p.o. q.d., Metoprolol extended release 50mg p.o. q.d., sublingual Nitroglycerin prn., Zocor 4mg p.o. q.d., Enteric coated aspirin 325mg p.o. q.d., Pepcid 20mg p.o. bid, vitamin E and C q.d., Elavil 25mg p.o. q.d. Albuterol and Atrovent metered-dose inhalers. Subject was discharged 3 days later on 7/13/03. The event was assessed by the investigator as unrelated to the study vaccine.		200302974	1						1	Circulatory collapse; Laboratory test abnormal	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0212771	11/21/2003	OH	73.0	73		F	11/07/2003	Patient received flu shot 10/27/03 and on 10/29/03 developed unusual sensations of lower extremity and right sided twitching. Taken to ER where had witnessed episode of global aphasia and confusion. CT there showed white spot found right lateral ventricle. Transferred to another hospital after 1 further episode, but MRI was normal. EEG showed rare suspicious left temporal sharp waves. Questioned of patient had TIA versus SE of vaccine. The medical records state lightheaded, slurred speech and flushing.					Y				Y	10/27/2003	10/29/2003	2	CT there showed white spot R lateral ventricle. MRI was normal. EEG showed rare suspicious left temporal sharp waves. Tests abnormal.	PVT	UNK			PVD; Increased cholesterol; Hypertension; Osteoarthritis; artrial fib; GERD			1						1	Aphasia; Confusional state; Dizziness; Dysarthria; Electroencephalogram abnormal; Flushing; Muscle twitching	FLU3~EVANS VACCINES~765876~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0212773	11/21/2003	WA	49.0	49		F	10/31/2003	Sat: onset of cold, through the week more sneezing, mucus in nose/sinus. Cough. Fever. No headache. Shoulder bones ached last 2 nights.									U	10/16/2003	10/25/2003	9		PUB	PVT	Wellbutrin, Depakote	NONE	Allergic to iodine - can't eat shellfish	cold~Influenza (Seasonal) (no brand name)~~39.00~In Patient	WA031972	1						1	Cough; Feeling cold; Pain; Pyrexia; Rhinorrhoea; Shoulder pain; Sneezing	FLU3~SANOFI PASTEUR~U1277AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212774	11/21/2003	NJ	56.0	56		M	10/31/2003	Flu vaccine administered 11 AM 10/30/03. Generalized itching approx 4 PM 10/30/03. Hives appeared that evening on posterior upper arms, trunk, buttocks, legs and waist area. Took Benadryl pills approx 8 PM 10/30/03. Hives reduced 10/31/03.									Y	10/30/2003	10/30/2003	0		PUB	PUB	Insulin, Humilog, Atenolol, diuretic	NONE	Diabetes			1						1	Pruritus; Urticaria	FLU3~EVANS VACCINES~765413~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212775	11/21/2003	CA	52.0	52		M	11/20/2003	3 days after flu vaccine administration, experienced rash on lower abdomen, shoulders and back. Next hoarseness, lost voice, runny nose, fever, chills, sore throat. Tx: cold remedies.									Y	10/21/2003	10/24/2003	3	NONE	OTH	PVT		NONE	NONE			1						1	Dysphonia; Laryngitis; Pharyngolaryngeal pain; Pyrexia; Rash; Rhinorrhoea	FLU3~EVANS VACCINES~765712~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212776	11/21/2003	AZ	39.0	39		F	11/20/2003	Severe nausea, vomiting, diarrhea. Onset within 24 hours of injection. Required IV fluids.				Y					Y	10/30/2003	10/31/2003	1		OTH	PVT			None indicated			1						1	Diarrhoea; Nausea; Vomiting	FLU3~EVANS VACCINES~765688~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212777	11/21/2003	NJ	30.0	30		F	11/19/2003	C/o SOB. Stated she had similar symptoms when she had anaphylactic reaction to eggplant/legumes. Breath sounds clear, no wheeze, rhonchi. Given Benadryl 25mg PO. Epi-pen administered. 911 called. Ambulance to hospital.				Y					U	10/30/2003	10/30/2003	0		OTH	PVT	Duolin inhaler, Combitide inhaler, Tenoclor, Elina, Singulair, Paxil, Nuvaring		Asthma, HTN, severe food allergies to legumes, peas, beans, peanuts, soya bean, aubergine (eggplant). Anaphylactic reaction to legumes and peas.			1						1	Dyspnoea	FLU3~SANOFI PASTEUR~U1137HA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212778	11/21/2003	MI	7.0	7		M	11/14/2003	Had flu shot 11/10/03. On 11/11/03, mom reported pain, redness, swelling and warmth. Examined by Dr 11/11/03. At that time, no warmth, 4 x 5cm area, slightly firm/indurated area of left upper arm. Placed on Keflex 250 mg/5ml 1 1/2 tsp tid for 10 days. Rechecked on 11/12/03 by PAC, noted erythema at left shoulder. No hardness or tenderness.				Y					Y	11/10/2003	11/11/2003	1		PVT	UNK		NONE	NONE			1						1	Feeling hot; Injection site erythema; Injection site induration; Injection site oedema; Pain	FLU3~SANOFI PASTEUR~U1139AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212779	11/21/2003	IL	1.36	1	.4	F	11/14/2003	In AM had shots (Hib, Prevnar, Influenza). Low grade fevers in day. 7:30-8 PM had seizure. Called 911. Temp 104 in ambulance. 2nd seizure in ambulance and 2 more in ER. Treated with Valium, fosphenytoin and Rocephin. CBC, blood culture, U/A, urine culture, lumbar puncture: normal. Head CT: normal. Awake EEG: normal. Sleep deprived EEG pending. Was observed in hospital with no more seizures. Seen by neurology Dx with complex febrile seizure. Day after fevers resolved pt developed a rash, possibly roseola. medical records state cyanosis. msv				Y					Y	11/06/2003	11/06/2003	0	See above (Box 7). All normal to date. Medical record states abnormal lab test. msv	PVT	PVT	NONE		NONE			1						1	Convulsion; Cyanosis; Laboratory test abnormal; Pyrexia; Rash; Roseola	FLU3~SANOFI PASTEUR~U1099AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE028AA~5~IM~LL~HIB (PROHIBIT)~1|PNC~PFIZER\WYETH~493480~5~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0212780	11/21/2003	OK	43.0	43		F	11/16/2003	Jittery, nausea, no vomiting, felt warm (face). Site of injection: hot to touch to 1/2 length of arm, tender and sore.									Y	11/16/2003	11/16/2003	0		MIL	MIL	Diuretic, Ibuprofen	Sore throat, coughing	Meniere's disease, migraines, bunions on feet, testing for arthritis			1						1	Feeling hot; Feeling jittery; Injection site warmth; Nausea; Pain	FLU3~SANOFI PASTEUR~U1147AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212781	11/21/2003	MI	28.0	28		F	11/07/2003	10/11: Dizzy, fatigue, redness at injection site. 10/12: Very red, pain, knot at site. Reported to provider at 10/13 appt. 10/13: Appointment: less red, pain same level as previous day. Area of edema, no fluctuant mass, tender to palpation. Assessment: aseptic abcess, rxn to immunization. Tx: 40mg Prednisone qd for 5 days; Motrin PRN, cold compresses PRN.				Y					Y	10/10/2003	10/11/2003	1	No tests ordered	OTH	OTH	Zolot, Clonazepan	NONE	NONE			1						1	Dizziness; Fatigue; Injection site erythema; Injection site mass; Injection site oedema; Pain	FLU3~SANOFI PASTEUR~U1090AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212782	11/21/2003	CA	46.0	46		F	11/11/2003	Got shot on Friday, had hives on Monday. Took Benadryl, didn't help, went back to (primary) Dr who prescribed Atarax on Tuesday, didn't help. He prescribed Prednisone, that worked, it went away. Hives in all warm areas, tops of legs, underarms, arms, behind ears, behind knees. Follow up on 12/10/03: Please let me know if I need any kind of follow up on influenza shot.									Y	10/03/2003	11/03/2003	31		PUB	PUB	Albuterol, Levoxyl, Soma, Flovent, Elavil, Darvocet, Rhinocort		Chronic pain with spine, asthma			1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0212810	11/21/2003	MT	44.0	44		F	11/21/2003	Day 4 following vaccination patient experienced 12 hours of chills. Day 9 patient experienced muscle aches which progressed to severe joint pain and severe swelling of wrists, hands and knees. This subsided on Day 12 following vaccination.									Y	10/28/2003	11/06/2003	9		PUB	PVT	Protonix 40 mg daily Orthocept daily					1						1	Arthralgia; Chills; Myalgia; Oedema peripheral	FLU3~SANOFI PASTEUR~U1127AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212867	11/21/2003	AZ	45.0	44		M	11/21/2003	PPV Vaccine administered at 11:00am 11/17/03 11/18/03 - redness & swelling near and above elbow 11/19/03 - swelling increases, elbow pain, rash across back, shoulders and chest. Antibiotic & antihistamine administered 11/20/03 - swelling and pain diminished some, antibiotic discontinued 11/21/03 - swelling and pain continue to decrease, rash still present.									Y	11/17/2003	11/18/2003	1	None	PVT	PVT			pollen			1						1	Erythema; Rash; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0212869	11/21/2003	WV	54.0	54		M	11/21/2003	Patient was referred to report his recent Myocardial Infarction (10/03/03).  The patient reports that he last received numerous immunizations in February 2003.  He denies any known problems that occurred around the time of the immunizations but is concerned that the vaccinations may have contributed to his cardiac problems.  He was deployed 08 April 2003 and denies any chest pain, heart burn symptoms occurring during the deployment.  He states that he sometimes became short of breath after exercise, but this was baseline for him.  On 10/02/03, he recalls resting in his room and feeling like he had heartburn.  He felt a strong urge to burp but was unable to do so.  He describes the sensation as a burning feeling in the middle of his chest.  He rates it as a 6/10 on a pain scale.  He did not experience any radiation to his neck, shoulder, or down his arm.  His medical records report that he had experienced intermittent chest pain/pressure at rest x 2-3 weeks.  He denies any palpitations, diaphoresis, headache, dizziness, cough, pedal edema, shortness of breath, or nausea/vomiting.  He went to Emergency Department and after elevated cardiac enzymes, initial EKG with ST elevation in Lead III, and subsequent T wave inversion in leads II, III, and AVF, he was diagnosed with an MI.  He was later transferred to a hospital and underwent a cardiac catheterization with stent placement. Since his discharge from the hospital, he denies any further chest pain or heartburn type symptoms.  He has just started the process of evaluation for a medical board based on his cardiac history and degenerative joint disease/osteoarthritis.  He is scheduled for another stress test on 11/15/03.			Y	Y	Y	3			U	02/15/2003	10/02/2003	229	Diagnostic Tests: oEKG:  NSR with T wave inversion in leads II, III, AVF, Q wave in Lead III oEchocardiogram:  o10/06/03:  Normal LVSF/ EF 55-60%, mild posterior lateral wall hypokinesis, no LV hypertrophy or enlargement, Normal Left Atrium.  Normal Mitral Valve with trace mitral regurgitation.  No aortic stenosis or regurgitation.  No tricuspid regurgitation.  Normal Right Ventricle. oMyocardial Perfusion Scan (Cardiolite) o10/07/03:  Abnormal myocardial perfusion study with ischemia in the inferolateral wall region. oCardiac Catheterization:  o10/10/03:  Summary:  1.  Severe two-vessel coronary disease with right coronary being the culprit of his recent non-Q myocardial infarction.  2.  The left anterior descending is very small caliber, not optimal for surgical intervention.  3.  Normal left ventricular systolic function.  (Estimated LVEF = 60-65%) oStent Placment:10/10/03:  Indication:  Patient with 95% mid RCA lesion and with a recent non-Q myocardial infarction.  Summary:  Successful PTCA/stent of the mid RCA lesion with 3.0/28 mm Penta stent with 0 residual. oChest X-Ray o10/09/03:  2 view chest demonstrates cardiomediastinal silhouette and pulmonary vascularity normal in appearance.  Mild prominence of infrahilar markings.  No infiltrate.  No effusion.  Impression:  Overall appearance may be due to mild chronic changes seen centrally but otherwise unremarkable. o10/03/03:  Findings:  Compared to 22 September 2003, portable frontal view of the chest shows no acute pathology. o09/22/03:  Lungs are mildly hyperinflated, but clear of infiltrate.  Heart and pulmonary vessels appear normal size.  Impression:  Non-specific hyperinflation.  Focal degenerative changes of the left distal clavicle of the AC Joint.   ***Chest X-ray had been order due to patient complaint of L sided chest pain intermittent x 1 week radiating along axilla to L post scapular region.  Laboratory Data: Cardiac Enzymes Date & Time CK    CK-MB  Rel Index  Troponin I 10/04/03 @ 0716 146   5.87 H 10/03/03 @ 1454 330 H 17.3 H 5.2 H 15.42 H 10/03/03 @ 0815 231 11.1 H 4.8 H 5.65 H 10/03/03 @ 0257 112   0.58  oChemistry Panel 10/10/03-WNL 10/09/03-WNL 10/04/03-WNL except CA 8.9 L (9.9-10.5), Anion Gap 9 L (10-20) 10/03/03-WNL  oStool 10/05/03-Negative for Occult Blood oCBC 10/10/03-WNL except MCH 31.6 10/09/03-WNL except MCH 31.8 10/04/03-WNL 10/03/03-WNL except WBC 11.2 H (4.4-11.0), Mono # 1.2 H (0.0-0.9) oUrinalysis 10/03/03- WNL oLFT  10/03/03-WNL oLipid Panel 10/03/03  Cholesterol 255 H (140-200) LDL  188 H (66-130) HDL  29  (27-67) VLDL  38 (0-42) Chol/HDL  8.9 Triglyceride  192 H (30-160)  oPT/INR   10/09/03:  PT  14.0, INR 1.0, PTT 33.7 10/03/03:  PT 12.7 (12.3-15.1), INR 1.0, APTT 31.5 (24.7-39.	MIL	MIL	Medications: oPlavix 75 mg po QD oImdur 30 mg po QD oLopressor 25 mg po BID oAspirin 325 mg po QD oLipitor 10 mg po QHS oAltace 2.5 mg po QD	None	Past Medical History: oHyperlipidemia oDJD bilateral ankles oPast history of migraines-now resolved oDenies any past history of  HTN, Angina, CHF, CVA, valvular heart disease, diabetes, asthma, cancer, or thyroid disease.  Surgical History: oL shoulder surgery			1						1	Chest pain; Dyspepsia; Dyspnoea; Laboratory test abnormal; Myocardial infarction; Laboratory test abnormal; Myocardial infarction; Chest pain; Myocardial infarction; Chest pain; Dyspepsia; Laboratory test abnormal; Myocardial infarction; Myocardial ischaemia	ANTH~EMERGENT BIOSOLUTIONS~Unknown~2~SC~LA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~Unknown~3~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~5377AA~1~~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~0980M~1~IM~UN~HEP A (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~UB269AA~1~SC~UN~MENINGOCOCCAL (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4020071~2~ID~LA~SMALLPOX (DRYVAX)~1|YF~UNKNOWN MANUFACTURER~UB358AA~1~SC~UN~YELLOW FEVER (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~3~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|MEN~SANOFI PASTEUR~UB269AA~1~SC~~MENINGOCOCCAL (MENOMUNE)~2|SMALL~PFIZER\WYETH~4020071~2~ID~LA~SMALLPOX (DRYVAX)~2|YF~SANOFI PASTEUR~UB358AA~1~SC~~YELLOW FEVER (YF-VAX)~2|ANTH~EMERGENT BIOSOLUTIONS~~2~SC~LA~ANTHRAX (BIOTHRAX)~3|FLUX~UNKNOWN MANUFACTURER~~3~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|HEP~UNKNOWN MANUFACTURER~5377AA~1~IM~UN~HEP B (NO BRAND NAME)~3|HEPA~MERCK & CO. INC.~0980M~1~IM~~HEP A (VAQTA)~3|MEN~SANOFI PASTEUR~UB269AA~1~SC~~MENINGOCOCCAL (MENOMUNE)~3|SMALL~PFIZER\WYETH~4020071~2~ID~LA~SMALLPOX (DRYVAX)~3|YF~SANOFI PASTEUR~UB358AA~1~SC~~YELLOW FEVER (YF-VAX)~3|ANTH~EMERGENT BIOSOLUTIONS~~2~SC~~ANTHRAX (BIOTHRAX)~4|FLUX~UNKNOWN MANUFACTURER~~3~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~4|HEP~MERCK & CO. INC.~~1~IM~~HEP B (RECOMBIVAX HB)~4|HEPA~MERCK & CO. INC.~0980M~1~IM~~HEP A (VAQTA)~4|MEN~SANOFI PASTEUR~~1~IM~~MENINGOCOCCAL (MENOMUNE)~4|SMALL~PFIZER\WYETH~~2~SC~~SMALLPOX (DRYVAX)~4|YF~SANOFI PASTEUR~~1~SC~~YELLOW FEVER (YF-VAX)~4	USA	Life Threatening,Hospitalisation	Influenza
0212871	11/21/2003	UT	36.0	36		M	11/21/2003	Headache, focusing problems									U	11/20/2003	11/20/2003	0	none	MIL	MIL	Effior, Prevacid, Altasenone	none	hypertension, acid reflux, depression			1						1	Disturbance in attention; Headache	FLU3~EVANS VACCINES~765757~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212872	11/22/2003	PA	49.0	49		M	11/22/2003	Rash on lowerlimbs began at day two.No likage was made with injection. On day five rash was disseminated across  torso and limbs. Rash resided. Malaise continues to day 7.Day 7 mid day fever reaches 102. Next three days peraks near 104 despite TYenol then Advil every 4 fours across all 24. Faint unprodcutive cough commences at day 9. Productive cough commences on day 12. Fever reduces to 102 on day 12 and is still present (peaks at 101 each day). at day 15 post injection. Neever any muscle pain or aches GI symptoms except some anorexia from days 7-11.				Y					N	11/07/2003	11/09/2003	2		PVT	PVT	Toprol, lipitor.	NONE	Iodine in cardiac imaging agent.			1						1	Anorexia; Cough; Malaise; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0212873	11/22/2003	TX	16.0	16		F	11/22/2003	onset hives 14 hours after vaccine.  72 hours later she is covered head to toe in hives. every inch of her body.  severe itching.				Y					N	11/19/2003	11/20/2003	1	blood test to rule out any bacterial or viral infection	UNK	UNK	Minocycline for acne	none	none			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212875	11/23/2003	IN	0.6	6		M	11/23/2003	11 days after receiving influenza vaccine in the L deltoid and varivax in the L upper arm he had a fever of 100-102, swelling and tenderness of the arm, and some groin tenderness.  No skin lesions developed.  Tenderness was around the varivax site.  It improved with motrin and lasted about 2 days.  No other treatment given.									Y	11/05/2003	11/16/2003	11	XR of arm nl	PVT	UNK	None at time of onset - put on Augmentin initially for cellulitis	None	Rash due to augmentin in past.			1						1	Injection site pain; Injection site swelling; Pyrexia	FLU3~SANOFI PASTEUR~U1255AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0569N~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0212876	11/23/2003	WI	68.0	68		F	11/23/2003	received shot 11/18/03 - 11:30                  Received  pnuemonia shot 11/18/03 - 11:30  AM -  about 1 hr later noticed arm was itching/didn't check it until about 5 hrs later - was swollen,painful,beet red from below shoulder to elbow - saw doctor next afternoon - Took antihistamine and pain pill / took a couple days for symptons to disappear  Not sure of the correct vaccines are listed below, know it was a pneumonia shot and the flu vaccine, but not which ones.									Y	11/18/2003	11/18/2003	0		PUB	UNK						1						1	Erythema; Oedema peripheral; Pain; Pruritus	FLU3~PFIZER\WYETH~~UNK~~LL~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|PPV~MERCK & CO. INC.~~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212877	11/23/2003	NC	54.0	54		F	11/20/2003	PT. RECEIVED VACC. ON 11-18-03, AT THAT TIME NO ADVERSE EVENTS WERE NOTED. SHE CALLED 2   DAYS LATER AND STATED THAT SHE WAS GETTING SOME REDNESS AND A LITTLE SWELLING AROUND THE INJECTION SITE AND IT WAS WARM TO TOUCH. WE ADVISED HER ON HOW TO CARE FOR THE SITE AND MONITOR, IF THINGS SHOULD GET WORSE, TO SEE SEE HER PHYSICIAN. WE INFORMED HER THAT WE WOULD REPORT THIS INCIDENT TO VAERS AND WHY WE HAVE TO DO THIS AND TOLD HER THAT WE WOULD FOLLOW UP WITH A PHONE CALL IN A COUPLE OF DAYS.									Y	11/18/2003	11/20/2003	2	N/A	UNK	UNK	N/A	NONE	ALLERGIES TO PENICILLINS AND DARVON			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Feeling hot; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1270AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1270AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0212815	11/24/2003	IL	69.0	69		F	11/17/2003	10 days after flu vaccine, pt developed rt sided face and HA pain, tenderness over temporal artery. High ESR > 5 responding to Prednisone. Porbable arteritis. 60-day follow up on 02/11/04: Pt has not recovered from adverse events. Persistant vasculitis-on Prednisone.			Y						U	10/04/2003	10/14/2003	10	High ESR >5, CRP 320	PUB	PUB						1						1	Arteritis; Headache; Pain; Tenderness	FLU3~EVANS VACCINES~765499~5~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening	Influenza
0212817	11/24/2003	CA	66.0	65		M	11/21/2003	Increased weakness since 10/31/03, starting with feet and numbness. 11/11-started with numbness of fingers. Hospitalized 11/03, 2 days in ICU, then out to unit. 11/21-still weak, definite dx of GBS. Still hospitalized.					Y				N	10/16/2003	11/04/2003	19	11/6/03 WBC 3.5, platelets 78,000, Hgb 9.6, HCT 29.6, CSF-protein 147, glucose 221 medical record states alk phos increased, SGOT inc, NPN increased, hyperglycemia and abnormal CSF. msv	PUB	UNK	Bizinjections, Zantac, Prinivil		Diabetes, ETOH abuse Medical records state hypertension, dyspnea, anemia, GIdisorder, GI bleading, hyperlipidemia, thrombocytopenia. msv			1						1	Aspartate aminotransferase increased; Asthenia; Blood alkaline phosphatase increased; Blood urea increased; CSF test abnormal; Guillain-Barre syndrome; Hyperglycaemia; Hypoaesthesia	FLU3~EVANS VACCINES~765143~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0212821	11/24/2003	WV	30.0	30		F	11/21/2003	Tenderness, swelling, induration and increased warmth right injection site increasing over 24 hours post injection.									Y	11/20/2003	11/20/2003	0		PVT	PVT		NONE				1						1	Feeling hot; Injection site induration; Injection site oedema; Pain	FLU3~EVANS VACCINES~766054~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212822	11/24/2003	CA	21.0	21		M		10-12 mm induration, 25mm inflammation in left arm. Attached page adds (after giving immunization record):  Pt reports to BMC c/o rash to left shoulder, + pruritic, + inflammation with approx 10-12 mm induration. Inflamed area is 25mm, pt scratched area slightly yesterday. A) Allergic reaction x 1099. P) 1) Consult with pt; 2) Obtain numbers to contact; 3) Benadryl 25mg PO TID for 3 days #9; 4) RTC PRN.									U	11/12/2003	11/13/2003	1		MIL	MIL		NONE	NONE			1						1	Hypersensitivity; Injection site induration; Injection site inflammation; Injection site oedema; Rash pruritic	FLU3~SANOFI PASTEUR~U1270AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212823	11/24/2003	IN	58.0	58		F	11/14/2003	Approx 20 minutes after injection, redness right inner forearm radiating to right deltoid, itching. Given ice and hydrocortisone cream for area. Called employer - pt fine.									U	11/02/2003	11/02/2003	0		OTH	OTH						1						1	Injection site erythema; Pruritus	FLU3~EVANS VACCINES~765883~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212824	11/24/2003	IL	70.0	70		F	11/16/2003	Both arms painful and disabled. Chills, vomiting, fever (101 degrees), aches. Symptoms subsided 11/12/03. Follow up on 12/03/03: Received follow up letter has no additional information to add to report (re: lot and manufacturer name).									Y	11/10/2003	11/10/2003	0		OTH	UNK	Synthroid, Enapril, Microzide, Lexapro, Aspirin	NONE	NONE			1						1	Chills; Pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1254AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0865N~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212825	11/24/2003	OK	49.0	49		M	11/16/2003	Vasovagal reaction - hypotension, brief syncope, thready pulse, nausea and dizziness. Place on oxygen at 2L/min vic NC. Pulse ox = 98-100% Sat. Improved with rest. 09:50 Sat = 99% on RA, BP 110/82, P 60.									Y	11/16/2003	11/16/2003	0	BP initially 80/60. BP 100/60 after 5 minutes. BP 110/8 at 10:11.	MIL	MIL	Ibuprofen	NONE	Previous similar reaction to influenza			1						1	Dizziness; Heart rate irregular; Hypotension; Nausea; Syncope; Syncope vasovagal	FLU3~SANOFI PASTEUR~U1147AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212826	11/24/2003	MA				M	10/24/2003	Inflamed right deltoid, painful, erythema 10cm, central induration, right axillary lymphadenopathy.									U	10/20/2003	10/21/2003	1		UNK	PVT		URI possible	Cystic fibrosis			1						1	Injection site erythema; Injection site induration; Injection site inflammation; Lymphadenopathy; Pain	FLU3~SANOFI PASTEUR~U1102AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1212M~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212827	11/24/2003	TX	42.0	42		F	10/31/2003	15 pox - arms, back neck, thighs (legs).									Y	10/28/2003	10/28/2003	0		PUB	PUB	NONE	NONE	NONE			1						1	Infection	FLU3~SANOFI PASTEUR~U1140AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0327N~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0212828	11/24/2003	WI	58.0	58		F	11/17/2003	Severe headache, chills, fever of 101.2 degrees, commencing 2 days after shot and lasting 3 days. Followed by severe headache for additional 6 days (total of 9 days). Treated with aspirin, no doctor called.									Y	11/06/2003	11/08/2003	2		PUB	PVT		NONE	Hypertension, allergic to sulfa and IV iodine			1						1	Chills; Headache; Pyrexia	FLU3~SANOFI PASTEUR~61143AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212829	11/24/2003	WI	77.0	77		M	11/18/2003	Hives on upper arms, chest appeared 5 days after receiving shot for flu. No treatment. Follow up on 12/10/03: 									Y	11/05/2003	11/10/2003	5		PUB	PVT	NONE	NONE				1						1	Urticaria	FLU3~SANOFI PASTEUR~U1103AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212830	11/24/2003	MI	45.0	45		F	11/17/2003	Headache, body aches, upset stomach (nausea; no vomiting); flushed, low grade fever. Began 1 day post vaccination, lasted 2 days.									Y	11/13/2003	11/14/2003	1		OTH	PVT		Runny nose, slight cough	NONE			1						1	Flushing; Headache; Nausea; Pain; Pyrexia; Stomach discomfort	FLU3~SANOFI PASTEUR~U1255AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212832	11/24/2003	IL	11.0	11		M	11/14/2003	Serum sickness; giant urticaria, fever 104 F, swollen wrist, body aches, cough (history of asthma). Swelling at site of Pneumovax but not flu shot.				Y					Y	10/23/2003	10/25/2003	2	PFT: FVC 2.88 (114%), FEV, 2.20 (96%) rates 76, FEF 25-75, 1.94/69%).	PVT	UNK	Singulair, Advair, Ventolin	NONE	Asthma, tree and grass pollen allergy			1						1	Cough; Oedema peripheral; Pain; Pyrexia; Serum sickness; Urticaria	FLU3~SANOFI PASTEUR~U1128AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0530N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212833	11/24/2003	CA	3.0	3		M	11/21/2003	1 day of redness, swelling, tenderness and warmth at the site of injection.									Y	11/19/2003	11/20/2003	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Feeling hot; Injection site erythema; Injection site oedema; Pain	FLU3~SANOFI PASTEUR~U10977AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212834	11/24/2003	TX	34.0	34		F	11/21/2003	Got flu shot 11/12/2003 and by 11/14/2003 broke out in hives, went to dermatologist and prescribed Zertec but still get hives every night even to this day 11/21/03.				Y					N	11/12/2003	11/14/2003	2		OTH	OTH	NONE	NONE	NONE			1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~5~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0212835	11/24/2003	GA	23.0	23		F	10/29/2003	Mild urticaria and macular rash arms and stomach, lasted 40 minutes. No wheezing, no change in VS/BP.				Y					Y	10/29/2003	10/29/2003	0	NONE	OTH	PVT	Pulmacort, Singulair, Clarinex					1						1	Rash macular; Urticaria	FLU3~SANOFI PASTEUR~U1134BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212837	11/24/2003	GA	40.0	40		F	11/18/2003	1 hour after receiving the Td and flu vaccine, I started itching around my neck. I looked in the mirror and notice I had hives on my neck, face, arms and legs. I took two Benadryl pills and went to bed. I woke about 4 hours later and notice the hives were gone.									Y	11/17/2003	11/17/2003	0		PUB	UNK	Advil	NONE	NONE			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1138AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0831AA~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0212838	11/24/2003	TX	9.0	9		F	11/17/2003	Flu vaccine given in left deltoid. Later that PM, left deltoid swollen to golf ball size per mother. Examined by Dr 11/6/03 at 10:50 AM area left deltoid about 0.6cm erythema, slightly warm to touch.				Y					Y	11/05/2003	11/05/2003	0		PVT	PVT	NONE	NONE	NONE			1						1	Feeling hot; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1094AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212839	11/24/2003	MI	70.0	70		F	11/17/2003	Pain and redness left deltoid area day after immunization. Was a little better by 2nd day. Pt given Augmentin 500, TID.									Y	11/11/2003	11/12/2003	1	NONE	PVT	PVT	Altace, Zyrtec, glucovance, Lipitor	NONE	High cholesterol, Nid DM, HTN, peripheral vasc disease			1						1	Injection site erythema; Pain	FLU3~SANOFI PASTEUR~U1127AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212840	11/24/2003	MI	46.0	46		F	11/17/2003	Right deltoid pain and redness, body aches, diarrhea, nausea. Augmentin 500 TID.									Y	11/04/2003	11/05/2003	1	NONE	PVT	PVT	Flonase, Celebrex	NONE	Allergies; osteoarthritis, high cholesterol	arm sore, red~Influenza (Seasonal) (no brand name)~~45.00~In Patient		1						1	Diarrhoea; Injection site erythema; Nausea; Pain	FLU3~SANOFI PASTEUR~U1127AA~3~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1026M~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212879	11/24/2003	CA	11.0	11		M	11/19/2003	4 vaccines on Friday, 11/11/2003. On Monday morning (11/17/2003) patient's mother phoned and said that patient was not feeling well on Saturday morning and that he had swollen lymph glands under his left arm and on left side of neck.  Patient did not have a fever.									Y	11/14/2003	11/17/2003	3	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Lymphadenopathy; Malaise	FLU3~EVANS VACCINES~765979~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~777A2~1~IM~RA~HEP A (HAVRIX)~1|TYP~SANOFI PASTEUR~W1582~1~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|YF~SANOFI PASTEUR~UB492AA~1~SC~LA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0212881	11/24/2003	FL	24.0	24		M	11/24/2003	Person states:   Localized rash to Rt. Deltoid,   Fever greater than 102 F,   Muscle aches,   General Malaise.									Y	10/10/2003	10/10/2003	0	N/A	PUB	PUB	None	None	Asthma General environmental allergies			1						1	Malaise; Myalgia; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U1125AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0664N~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U0842AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0212882	11/24/2003	PA	66.0	65		M	11/24/2003	Patient expired on 11/18/03 due to ruptured Aorta.  Presented at ER 11/14/03 after not feeling well, for a few days, complaining of tiredness and loss of appetite. Discharge Summary received on 12/01/2003 states change in mental status.	Y	11/18/2003							N	10/30/2003			none known	UNK	UNK	None known	Per patient, denied any illness at the time of administration of Flu vaccine.	Patient denied any allergy to eggs or Thimerisol.  No other medical information available.			1						1	Aneurysm; Anorexia; Fatigue; Malaise; Thinking abnormal	FLU3~EVANS VACCINES~765955~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0212885	11/24/2003	GA	74.0	74		M	11/24/2003	Vaccine given 11/19/03 approx 10:30 am. Came in the next day and c/o pain in right arm that had begun that night after vaccine to swell and was painful.  Still swollen 3 1/2 inches below vaccine site and hot to touch the next day.									Y	11/19/2003	11/19/2003	0		PUB	PUB	Sotalol hcl 80mg  felodipine 2.5mg sa-tab mexiletine hcl 150mg cap lisinopril 40mg tab simvastatin 40mg clonazepam 1 mg ecotrin 325mg	no	pacemaker defrilator hbp			1						1	Feeling hot; Pain; Swelling	FLU3~SANOFI PASTEUR~61132aa~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0869n~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212886	11/24/2003	VA	74.0	74		M	11/24/2003	PT HAS PROLONGED LOCAL DISCOMFORT GREATER THAN 4 WEEKS. BEGAN MORNING FOLLOWING VACCINATION CONTINUING DAILY. ATTEMPTED MASSAGE AND ASPIRIN-BOTH INEFFECTIVE. ABLE TO DO FULL RANGE OF MOTION									U	10/27/2003	10/28/2003	1	NONE	MIL	MIL	TETRACYCLINE	NONE	ROSCEA, ALLERGIC TO PENICILLIN, CODEINE, BEE STINGS			1						1	Discomfort; Joint range of motion decreased	FLU3~SANOFI PASTEUR~U1147AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211878	11/25/2003	OH	48.0	48		F	11/03/2003	After receiving 0.5cc Fluzone, the employee complained of feeling faint (approximately  30 seconds after). After sitting her down and approximately 1 minute after, the she went into anaphylactic shock (no pulse, respirations, pale, cool/clammy, loss of bladder control). I administered 0.2cc epinephrine and she responded in approximately 30 seconds. Meanwhile, EMT arrived for transport to hospital.  Follow up on 12/03/2003: Patient is a 48 year old healthy, white female.  She has a history of hypothyroidism and is taking Synthroid.  After reviewing her Pt acknowledgement for Influenza form, I asked her if she had any allergies, including those to eggs, chicken, or thimersol, and if she could be pregnant.  I also asked her if she ever got the flu vaccine.  Her response to all those questions was no.  She stated that she was afraid of needles but has gotten more used to them since she has periodic blood draws for her thyroid levels.  She stated that she has a tendency to faint.  I gave her the flu vaccine (.5cc, Aventis U1271AA) into her left deltoid.  Approximately 30 seconds later she said she was feeling faint, and I had her sit down and then put her head down between her knees.  Approximately 1 min. after that, I noticed that she was sitting upright and back into the chair and unresponsive.  Her skin was pale, cool and clammy, she felt rigid, pulse was barely palpable.  There was loss of bladder function.  While I sliding her to the floor, I could not feel a pulse, I yelled for help (we were in a isolated area), I prepared to give her CPR first, I injected her with .2cc epinephrine - right outer arm.  A person appeared and I told her to call 911 - quickly.  Meanwhile, pt appeared to be responding, feeling a pulse, I rolled her to her side and she became coherent at that time, EMT appeared at approximately 8:00am and VS were monitired-pulse ox98%, BP 100/68, P82.  By this time, pt was talkative and was asking what had happened, she agreed to be transported to the hospital.  After discussion with staff in the office, and gratitude for quick thinking and level-headedness.  I left for the office and notified my PC with a vm at 10:30am on 10/31/03 to inform them about the incident.  At 10:50am I received a call from the MD asking questions concerning the incident, I reiterated as the above sequence of events.  He informed me that he will be releaseing pt shortly.  At 11:00am I called the office and spoke about the events.  I plan to follow up on Monday on pt's status.			Y		Y			Y	U	10/31/2003	10/31/2003	0		UNK	UNK			Hypothyroidism			1						2	Anaphylactic reaction; Apnoea; Cold sweat; Dizziness; Pallor; Pulse absent; Anaphylactic shock; Apnoea; Cold sweat; Pallor; Pulse absent; Urinary incontinence	FLU3~SANOFI PASTEUR~U1271AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1271AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0212288	11/25/2003	FL	66.0	66		F	10/30/2003	Approximately hours after vaccine administered deltoid area left arm began to become painful, swollen and warm to touch. Patient applied ice and took Moltrin.  She repeated this, and around 15 hours post immunization area began to be less painful.					Y	3			Y	10/29/2003	10/30/2003	1	Now 18 hours after Immunization are warm, red, and measures 11 x 14mm	PUB	PUB		none	Sulfa, Morphine, Cestiene, Tetracycline			1						2	Cellulitis; Injection site pain; Injection site swelling; Injection site warmth; Erythema; Feeling hot; Pain; Swelling	FLU3~SANOFI PASTEUR~075AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0873M~2~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~075aa~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0873m~2~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0212877	11/25/2003	NC	54.0	54		F	11/20/2003	Patient received vaccination on 11/18/2003 at that time, there were no adverse events reported/seen.  3 days later, she called and said that she was starting to experience redness and swelling around injection site and the area was warm to touch.  We advised her on what to do to care for the site and also advised her to see a physician if things worsened; will call in 2 days.									Y	11/18/2003	11/20/2003	2	NONE	OTH	OTH	NONE	NONE	PCN/Darvin			1						2	Injection site erythema; Injection site swelling; Injection site warmth; Feeling hot; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1270AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1270AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0212907	11/25/2003	OH	20.0	20		F	11/14/2003	Fever to 104 deg, pain, swelling, redness R arm with development of localized severe sterile abscess R deltoid.					Y	3			Y	11/04/2003	11/05/2003	1		PVT	PVT		Sinusitis-mild, afebrile	Asthma, Aspirin sensitivity, sulfa, Eryth, Demsiol			1						1	Abscess; Erythema; Oedema peripheral; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1068AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0287N~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0212911	11/25/2003	SC	31.0	31		F	11/17/2003	Marked local reaction on arm with axillary tenderness, no node increase, redness measuring 3 long x 2 wide, area raised and warm. Denies fever/malaise. Has Hx other allergies. 1st flu vaccine! Tx: Zyrtec tabs given by Corp Health MD. Seen by MD for discomfort. Follow up on 12/10/03: Less than 24 hours after vaccination, began AM of 10/30/2003.				Y					U	10/29/2003	10/30/2003	1	None, seen by Employee Health MD on 10/31/03 x T, no last time.	UNK	UNK	NONE		Hx allergies, not to eggs/thimersol			1						1	Discomfort; Feeling hot; Injection site erythema; Injection site swelling; Pain	FLU3~SANOFI PASTEUR~U1137GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212912	11/25/2003	NC	72.0	72		F	10/27/2003					Y					Y	10/17/2003	10/21/2003	4	NONE	PUB	PVT		NONE	UNK			1						1	Unevaluable event	FLU3~EVANS VACCINES~765852~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0709M~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212913	11/25/2003	NC	53.0	53		M	11/20/2003	No significant adverse reaction. Myalgia 2 hours to flu vaccine, local reaction. Fuce ROM.									Y	10/31/2003	11/01/2003	1	NONE	PUB	PVT	None given	NONE	NONE			1						1	Joint range of motion decreased; Myalgia	FLU3~SANOFI PASTEUR~765797~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212914	11/25/2003	NC	78.0	78		F	10/24/2003	This pt received a flu and pneumonia vaccine on 10/23/03. Pain, swelling and bruising to right deltoid, elbow and forearm. Treated with Ibuprofen. Resolved as of 11/14/03.									Y	10/23/2003	10/24/2003	1	NONE	PUB	PVT	NONE	NONE	NONE			1						1	Contusion; Injection site oedema; Pain	FLU3~EVANS VACCINES~765852~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0864N~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212915	11/25/2003	NC	57.0	57		F	11/20/2003	Left deltoid with 2-4 cm bruising. C/o pain and tenderness at site. Impression: minor injection site reaction. Symptoms resolved as of 11/14/03.				Y					Y	10/31/2003	11/01/2003	1	NONE	PUB	PVT	None	NONE	Arthritis			1						1	Contusion; Pain	FLU3~EVANS VACCINES~765852~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212916	11/25/2003	NC	46.0	46		F	11/20/2003	<30mm pump knot and bruise to left deltoid at injection site. No site bleeding, no systemic Sx's. Full ROM. Impression: traumatic injection with bruising.				Y					Y	10/31/2003	11/02/2003	2	NONE	PUB	PVT	NONE	NONE	NONE			1						1	Contusion; Injection site mass	FLU3~EVANS VACCINES~765797~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212917	11/25/2003	NC	32.0	32		M	11/20/2003	11/5/03: Right deltoid full ROM, no fever, rash or bruising, no system symptoms, sensation WNL equal strength. Advised Ibuprofen for muscle tenderness. RTC on 11/14/03 with continual symptoms. Continue same care.				Y					Y	10/31/2003	11/03/2003	3	NONE	PUB	PVT	NONE	NONE	NONE			1						1	Myalgia	FLU3~EVANS VACCINES~765852~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212918	11/25/2003	NC	58.0	58		F	11/20/2003	10/27/03 Pt c/o blisters and itching of scalp for 2 days. Rash moved to neck and forehead, rash and swelling. Next AM hives over body, lips swollen, joint swelling and pain. Impression: Possible adverse flu vaccine reaction. Symptoms resolved as of 11/10/2003.				Y					Y	10/23/2003	10/27/2003	4	11/04/03: CBC - WNL. Basic metabolic panel - WNL.	PUB	PVT	NONE	NONE	NONE			1						1	Arthralgia; Blister; Face oedema; Joint swelling; Oedema; Pruritus; Rash; Urticaria	FLU3~EVANS VACCINES~765852~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212919	11/25/2003	CA	4.0	4		M	10/21/2003	Erythema, swelling and tactile warmth. The pt not seen by provider. Grandfather left with child before he could be seen by provider. 10/29/03 TC to grandmother. All symptoms resolved.									Y	10/19/2003	10/20/2003	1	NONE	PUB	PUB	NONE	NONE	Asthma		CA030133	1						1	Feeling hot; Injection site erythema; Oedema	DTAP~SANOFI PASTEUR~C1387AA~5~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1112AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0422N~2~IM~LA~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~W1233~4~SC~RA~POLIO VIRUS, INACT. (POLIOVAX)~1	USA		Influenza
0212920	11/25/2003	CA	26.0	26		F	10/10/2003	Pt returned to STD clinic, appeared anxious, stating upper lip quivering at times. NP examined pt, noted upper lip intermittent twitching. Gave Benadryl 50mg oral dose. Sx subsided. Pt given instructions to take Benadryl 25mg orally every 6 hours for 24 hours. Sx resolved.									Y	10/10/2003	10/10/2003	0		PUB	PUB		NONE	NONE		CA030132	1						1	Anxiety; Muscle twitching	FLU3~EVANS VACCINES~765143~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212921	11/25/2003	AZ	36.0	36		F	11/20/2003	Six hours after injection developed hives all over body. Face became swollen, was itchy. Pt was seen in urgent care, was given a steroid injection and prescriptions for prednisone and Atarax.				Y					U	11/19/2003	11/19/2003	0	UNK	OTH	PVT	Claritin D	NONE	Environmental allergies, has had hives after Ibuprofen in the past.			1						1	Face oedema; Pruritus; Urticaria	FLU3~EVANS VACCINES~765707~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212922	11/25/2003	OR	66.0	66		F	11/19/2003	Right arm red, swelling. Rx of Keflex given if Sx worsen/cellulitis.				Y					U	11/18/2003	11/18/2003	0	Physician exam: Rx of Keflex given if Sx worsen/cellulitis.	PVT	PVT		NONE	NONE	red, swelling~Pneumo (Pneumovax)~~0.00~In Patient		1						1	Cellulitis; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~765667~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0287N~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212923	11/25/2003	OR	23.0	23		F	11/19/2003	Cellulitis left arm. Rx given of Keflex.				Y					U	11/16/2003	11/16/2003	0		PVT	PVT		NONE	No spleen			1						1	Cellulitis	FLU3~SANOFI PASTEUR~766055~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0287N~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212924	11/25/2003	VA	38.0	38		F	11/19/2003	90 minutes after receiving flu shot returned to clinic c/o swollen right eye, hoarse voice and slight itching right leg. Rx with 50mg Benadryl IM, evaluated by 911 but refused transport to ER. Better by next AM.									Y	10/29/2003	10/29/2003	0	NONE	OTH	OTH	UNK	NONE	No allergies			1						1	Dysphonia; Eye oedema; Pruritus	FLU3~EVANS VACCINES~765601~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212925	11/25/2003	VA	33.0	33		F	11/19/2003	20 minutes after receiving flu shot c/o throat closing. Given 50 mg Benadryl IM, after 10 minutes still c/o tightness, given 1:000 Epi. Transported via 911 to ER for observation and eventual discharge after several hours.				Y					Y	10/28/2003	10/28/2003	0	NONE	OTH	OTH		NONE	UNK			1						1	Throat tightness	FLU3~EVANS VACCINES~765601~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0212926	11/25/2003	DC	36.0	36		F	11/19/2003	5 minutes after flu shot, c/o tightness/thickness in throat. Rx with 0.3cc Epinephrine SQ, Benadryl 50 mgm IM and 0.2cc Epheph. Within next 45 minutes; evaluated by 911 but refused to go with them; transported by family to private MD. Pt states was better by next AM after 2 more doses of po Benadryl.				Y					Y	11/14/2003	11/14/2003	0	NONE	MIL	PVT	UNK	UNK	UNK, states has no allergies			1						1	Throat tightness	FLU3~SANOFI PASTEUR~U1287AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212927	11/25/2003	WA	61.0	61		F	11/17/2003	I noticed around noon on Sat. 11/15/03 that my bicep not only hurt, but was sensitive to touch. By that evening red streaks had started from armpit to below the elbow. By morning, sensitivity was great and streaks were angry They continued below the elbow.				Y					Y	11/10/2003	11/15/2003	5		OTH	PVT		NONE	Penicillin, aspirin			1						1	Cellulitis; Injection site pain; Myalgia	FLU3~SANOFI PASTEUR~U1256AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212928	11/25/2003	MS	62.0	62		F		Pt received flu shot on 11/11/03 in AM. The next day felt bad. After 24 [hours] developed fever up to 104 degrees F., chills, cough, headache and started having (unreadable) local reaction. Left gluteal area with localized redness. Went to ER. Found to have CXR abnormality and given Zithromax for apparent pneumonia and sent home. Pt has been having fever for 2 days and came to my office 4 days after a flu shot. She had no fever, her physical exam was remarkable for wheezing (she is chronic COPD pt) and localized redness (measuring 16 x 10cm in the left gluteal region where flu shot was administered. Pt was given Avelox 400, po for 5 more days and Bartoban cream to apply on a red skin area. Pt is now recovering well (no fever, localized redness disappearing as of 11/18/03).									Y	11/11/2003	11/12/2003	1	See attached lab from 4 days after a shot.	PVT	OTH	Zocor, Prevacid, Adibic, Weltrin, nebulizer, No histologic abnormalities stopped sign med	None known	NKDA; COPD, DM, HM, hyperlipidemia, SP angioplasty with FP, SP pneumonotomy(?)			1						1	Chills; Cough; Feeling abnormal; Headache; Injection site erythema; Pneumonia; Pyrexia; Wheezing	FLU3~EVANS VACCINES~765670~UNK~IM~GM~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0702M~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212929	11/25/2003	KS	33.0	33		F	11/10/2003	C/o pain in right deltoid when raising arm to adduction or rotating arm internally. Very painful at night, wakes me up at night hurting.									U	10/29/2003	11/02/2003	4		PVT	UNK			PCN and latex; hx of melanoma of skin			1						1	Pain; Sleep disorder	FLU3~EVANS VACCINES~765196~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212930	11/25/2003	MO	25.0	25		F		States broke out in nickel size hives over entire body 4 hours after getting shot. Took Benadryl and states they appear to be going away. Instructed to notify her MD.									U	11/06/2003	11/06/2003	0		PUB	PUB	NONE	NONE	NONE			1						1	Urticaria	FLU3~EVANS VACCINES~765707~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212931	11/25/2003	NE	5.0			M		Localized reaction: arm where injection was given became warm, red, felt hard, swollen to size of grapefruit.									Y					PVT	OTH		NONE				1						1	Feeling hot; Injection site erythema; Injection site induration; Injection site oedema	FLU3~SANOFI PASTEUR~U1267AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212932	11/25/2003	CA	29.0	29		M	11/17/2003	Moderate swelling of area where shot was given, redness, tingling, aching and numbness in fingers and elbow, aching in armpit, pain.				Y					Y	11/12/2003	11/14/2003	2		OTH	UNK	PPD Aventis C1262AA, ID, left forearm; Levaquin	NONE	Allergic to penicillin	swelling~Anthrax (Biothrax)~6~27.00~In Patient		1						1	Hypoaesthesia; Injection site erythema; Injection site oedema; Pain; Paraesthesia	ANTH~EMERGENT BIOSOLUTIONS~FAV078~7+~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~EVANS VACCINES~765756~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|MEN~SANOFI PASTEUR~UB18SAB~UNK~SC~RA~MENINGOCOCCAL (MENOMUNE)~1	USA	Emergency room visit	Influenza
0212933	11/25/2003	MO	39.0	39		F	11/13/2003	Returned to clinic area after 15 minutes with SOB and loss of voice. Had administered albuterol prior to coming in room. 911 called. Administered .3 cc epinephrine. Right arm after tourniquet placed above injection site left arm. Felt better 2 minutes later. EMS arrived and took pt to hospital.									Y	11/13/2003	11/13/2003	0		UNK	UNK	Albuterol					1						1	Aphasia; Dyspnoea	FLU3~EVANS VACCINES~765707~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212934	11/25/2003	PA	55.0	55		F	11/17/2003	Hives - started 10/29/03 lasted 2 weeks. Shot given 10/27/03. Steroids administered - pill form and Benadryl. Inside throat swollen.				Y					Y	10/27/2003	10/29/2003	2		MIL	MIL		NONE	Fibromyalgia, rosacea, sinus, other allergies			1						1	Throat tightness; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0212935	11/25/2003	WI	72.0	72		F	11/13/2003	Onset 1 hour after injection noted pain upper right arm - shoulder - couldn't lift shoulder, arm - very painful. Redness evening of injection upper right arm. Pain better now. Redness inner aspect upper arm/anticubetal area now.				Y					Y	11/11/2003	11/11/2003	0	NONE	PVT	PVT	Fosamax, Clonazepam, Aleve	NONE	Allergic: Biaxin; Osteoporosis			1						1	Erythema; Joint range of motion decreased; Pain	FLU3~EVANS VACCINES~765797~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0947N~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0212936	11/25/2003	MN	62.0	62		F	11/17/2003	45 minutes after receiving flu shot pt developed hives - upper chest, face, neck and some chest heaviness. Pt has numerous food allergies and had eaten at Wendy's after injection. Treatment: Benadryl 50 mg IM, Zyrtec 10 mg PO suspension and Diprosone 0.05% cream.									Y	10/22/2003	10/22/2003	0	NONE	PVT	PVT	Levoxyl, Glybenide, Protonix, K+, HCTZ, Zyrtec, Neurontin, Premarin, Pravachol, Monopryl	NONE	Allergies: Penicillin, Lexapro, Keflex, Novacaine; Diabetic, hypertension neuropathy			1						1	Chest pain; Urticaria	FLU3~EVANS VACCINES~765875~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0212937	11/25/2003	NC	38.0	38		M	11/18/2003	Swelling from just below shoulder to just above elbow (left arm). Tricep was red, hot to the touch, accompanied by low grade fever (101 degrees for 36 hours). Followed by bruising. (Recovering 6+ days).									Y	11/13/2003	11/13/2003	0		MIL	MIL		NONE	NONE			1						1	Contusion; Injection site erythema; Injection site oedema; Injection site warmth; Pyrexia	ANTH~EMERGENT BIOSOLUTIONS~FAV080~5~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1129AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212938	11/25/2003	WA	55.0			F	11/12/2003	Pt had 3 diameter band swath around upper arm - inch below injection site, edematous and red for 3 days post vaccination.									Y					OTH	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1142AA~UNK~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0564N~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212939	11/25/2003	ND	4.0	4		F	11/20/2003	1 minute generalized seizure. Follow up 12/08/2003: Occurred while sleeping with mother.  1 min shaking, followed by brief flacid period.  There were no postictal drowsiness.  Child under tx for cough, prurulent runny nose, sinusitis.  During or immediately before the seizure, the patient had a fever.  It is unknown what the temperature was before the seizure.  The seizure lasted approximately 1 minute. Augmentin-started day before.  Tylenol 9 hours before seizure onset.  Date of first clinic/ER hospital visit for the reported seizure: 11/18/2003.  Diagnosis was made by ER physician.				Y					Y	11/10/2003	11/18/2003	8	NONE	PVT	PUB	Augmentin	Sinusitis	NONE			1						1	Convulsion; Pyrexia	FLU3~SANOFI PASTEUR~U1142AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212940	11/25/2003	IL	55.0	55		F	11/11/2003	Itching, mild flushing 11:00 p.o. Zyrtec 10mg administered. Rx: Epi Pen given to pt with instructions if needed.									Y	11/11/2003	11/11/2003	0	NONE	PVT	PVT	Mantoux Tubersol-Aventis Pasteur-C1260AA-left forearm	NONE	Allergy: NSAIDS	tongue swelling~Influenza (Seasonal) (no brand name)~~52.00~In Patient		1						1	Flushing; Pruritus	FLU3~SANOFI PASTEUR~U1094AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212941	11/25/2003	MA	61.0	61		F	11/06/2003	12 hours after vaccination, severe joint and muscle pain, fever, lower abdominal pain lasting 38 hours.  Still having abdominal pain and intermittent hot flashes-temperature normal at 96.									Y	11/04/2003	11/04/2003	0	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Abdominal pain lower; Arthralgia; Hot flush; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1102AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212942	11/25/2003	AL	5.0	5		M	11/19/2003	Right arm with large area erythema, urticaria extending from mid upper arm to elbow.				Y					U	11/17/2003	11/17/2003	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Erythema; Urticaria	FLU3~SANOFI PASTEUR~U1145AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212943	11/25/2003	CA	6.0	6		M	11/18/2003	Per mom received flu vaccine at 15:40, nothing during evening-not sure what time-hives developed.  Gave Benadryl per mouth, no distress.									Y	11/17/2003	11/17/2003	0	NONE	PVT	PVT	NONE	Nasal congestion	Nasal allergies; Heart murmur, Exercise Induced Bronchospasm			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1256AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212944	11/25/2003	WI	18.0	18		M	11/06/2003	Received influenza vaccine-2003 on 11/04/2003 at 09:00.  Noticed he was breaking out with a rash to arms by around 16:00.  On 11/04/2003, continued to break out with rash to arms, trunk and legs.  Rash pinpoint raised and red.  Also complained of rash being itchy.  Seen at medical center on 11/06/2003 by MD and advised to take Benadryl 50mg, every 4 hours as needed and to return for re-check on 11/07/2003.  Does state he had a cold about 1 week ago which is almost gone.									Y	11/04/2003	11/04/2003	0	NONE	OTH	PVT	Multi-vitamin Daily	NONE	NONE			1						1	Pruritus; Rash; Rash erythematous	FLU3~SANOFI PASTEUR~U1267AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212945	11/25/2003	MN	29.0	29		F	10/24/2003	Significant pain and swelling at injection site extending to shoulder and entire upper arm (right).									Y	10/21/2003			NONE	PVT	OTH	NONE	Anxiety	Allergy/Hydrocodone			1						1	Injection site oedema; Injection site pain	FLU3~EVANS VACCINES~765670~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0564N~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212946	11/25/2003	PA	57.0	56		F	10/23/2003	1) Burning sensation dorsum of hands; 2) Redness of face, neck, chest, ear; 3) Lightheadedness; (Accidentally took PCN tab - not took same pill again and had anaphylactic reaction)				Y					U	10/14/2003	10/15/2003	1	NONE	OTH	OTH	Lopessor; HTZ, K+	NONE	Hypertension; PCN			1						1	Dizziness; Erythema; Skin burning sensation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0212947	11/25/2003	CA	55.0	55		M	11/17/2003	10/09-flu shot given first time getting a flu shot.  Dull, slight burning, soreness left deltoid.  Hurts when moving the arm a certain way and pain with palpation of the left deltoid.  Left deltoid-normal appearance-no systemic reaction.									N	10/09/2003	10/10/2003	1	NONE	OTH	PUB	Lipitor; ASA; Aciphex	NONE	NONE			1						1	Hypokinesia; Injection site pain; Sedation; Skin burning sensation	FLU3~SANOFI PASTEUR~U1260AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0212948	11/25/2003	CA	2.0	2	.0	F	11/24/2003	Right leg area red spots, hard and hot, went to clinic.									Y	11/21/2003	11/23/2003	2	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Erythema; Injection site induration; Injection site warmth	FLU3~SANOFI PASTEUR~U1078AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~494311~4~IM~~PNEUMO (PREVNAR)~1	USA		Influenza
0212949	11/25/2003	NH	81.0	81		F	11/24/2003	Pain at injection site, fever.  19x9cm erythema, heat, tenderness at left lateral arm.									U	11/20/2003	11/20/2003	0	NONE	PVT	OTH	Plarix; Aciphex; Zestoretic; Altos	NONE	Type 2 Diabetes Mellitus; History of circumflex artery, hypertension, mild dementia			1						1	Injection site erythema; Injection site pain; Injection site warmth; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~U1254AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0945N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0212950	11/25/2003	MA	55.0	55		F	11/24/2003	Redness at site, warmth, swelling.  Tylenol as needed for discomfort.									U	11/19/2003	11/21/2003	2	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Feeling hot; Injection site erythema; Injection site oedema	FLU3~EVANS VACCINES~764955~2~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213037	11/25/2003	SD	0.8	0	.9	M	11/25/2003	Flu Vaccine (Aventis #U1264AA) 0.25 cc given IM at 1655 on November 20, 2003.  Mom reports that about 24 hours later, he developed a raised red rash on his forehead, but no other symptoms.  No fever and no apparent itching; no difficulty breathing.  The next 48 hours, the rash became lighter on his forehead and then appeared on his chest, arms, and legs.  On November 25th mother reports that he now is having nasal congestion with green nasal discharge and a temperature of 100.5; says that he may have had a runny (watery) nose the day of the vaccine.  She has contacted her physician's office and says that they advised her the child should not have the second dose of the flu vaccine.									Y	11/20/2003	11/21/2003	1		PUB	PUB						1						1	Nasal congestion; Pyrexia; Rash erythematous; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1264AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213038	11/25/2003	KY	38.0	38		M	11/24/2003	Approx 5-15min after shot, pt c/o while in care with wife sensation in arm- felt medicine gown arm, tongue felt funny throat scratchy, Patient not with her when wife called and gave the report.									U	11/24/2003	11/24/2003	0		PUB	PVT	not known	no	no		KY2003098	1						1	Feeling abnormal; Pharyngitis	FLU3~SANOFI PASTEUR~U1254AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213039	11/25/2003	MS	46.0	46		F	11/25/2003	I TOOK THE FLU SHOT AT ABOUT 10:00 AM ON NOVEMBER 10, 2003.  THAT AFTERNOON ABOUT 1:00 I STARTED TO HAVE SEVERE STOMACH CRAMPS WHICH CONTINUE ALL AFTERNOON AND NIGHT.  I DID NOT GO TO THE DOCTOR AT THIS TIME. ON WEDNESDAY MORNING THE 12TH MY FINGERS ON MY RIGHT HAND BEGAN TO TINGLING. THIS EVENTALLY CONSUMED MY WHOLE RIGHT HAND WITH THIS SENSATION AND THEN I START TO FILL IT IN THE RIGHT SIDE OF MY FACE.  AT THIS POINT I HAVE BEEN TO THE EMERGENCY ROOM, A CLINIC, FAMILY PHYSICAN AND A NEUROLOGIST.  I AM SCHEDULED TO HAVE A SPINAL TAP DONE ON MONDAY TO CHECK FOR MS AND I SUGGESTED ALSO TO CHECK FOR GBS.				Y					U	11/10/2003	11/10/2003	0	EEG MRI MRA  SPINAL TAP (SCHEDULED NOV. 1, 2003)	PUB	UNK	CLIMARA HARMONE PATCH	NONE PRESENT	NONE			1						1	Abdominal pain; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0213063	11/26/2003	VA	82.0	81		F	11/20/2003	30 minutes after receiving flu shot (patient was at home by then), complained of feeling lightheaded. After 2 hours told her daughter, who noted left sided weakness. Patient admitted to hospital with diagnosis of right CVA; hospital for 7 days, then in rehab facility. The discharge summary state diabetic, and hypertensive. Recover partially (according to daughter) has residual weakness- uses a walker, needs 24 personal care assistance.				Y	Y	7		Y	N	10/25/2003	10/25/2003	0	UNK	OTH	PVT	UNK	UNK	UNK			1						1	Cerebrovascular accident; Diabetes mellitus; Dizziness; Gait disturbance; Hemiparesis; Hypertension	FLU3~EVANS VACCINES~765707~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0213064	11/26/2003	ID	52.0	51		F	11/20/2003	11/5/03 Pain right kidney spreading midsection front and back. Skull felt on fire; front chest pressure. 11/7/03 ED; told injection from flu shot; week in hospital.  No pain.  11/15 back home. 11/16 ED; testing done; nothing found. So question flu shot. The discharge summary state myalgia and gastric erosion. Annual follow up on 02/10/04: Pt has recovered from adverse events.				Y	Y	5			U	11/03/2003	11/05/2003	2	Platelets/Liver enzymes elevated. All other tests negative from heart. Gastroscopy: r/o CA.	PUB	OTH		NONE	CA; Leukemia; Hypertension; Allergy to Penicillin and Codeine.			1						1	Chest discomfort; Gastritis; Laboratory test abnormal; Myalgia; Renal pain	FLU3~SANOFI PASTEUR~U1093AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0213067	11/26/2003	NJ	4.0	4		M	11/25/2003	Right arm 11 1/2cm x 18 1/2cm redness without warmth.				Y					Y	11/17/2003	11/17/2003	0		PVT	PVT						1						1	Injection site erythema	DTAP~SANOFI PASTEUR~U1606AA~5~IM~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U10761AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X0148~4~SC~RA~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0381M~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0213068	11/26/2003	NJ	4.0	14		M	11/25/2003	Right upper arm with about 10cm redness, induration and warmth.				Y					Y	10/23/2003	10/25/2003	2		PVT	PVT						1						1	Feeling hot; Injection site erythema; Injection site induration	DTAP~SANOFI PASTEUR~U1406AA~5~IM~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1076AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W1624~4~SC~RA~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0608N~2~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0213069	11/26/2003	NH	58.0	58		M	11/25/2003	Pt c/o very sore arm after receiving the flu shot. Sometimes he could not lift arm. States it's lasted for 2 weeks. Did not have any bruising of swelling. Will see personal physician on 11/26/03.									U	11/12/2003	11/12/2003	0		PUB	PUB	Serzone	NONE	NKA, prostate cancer (had Lupron-Depo shot in August 2003)			1						1	Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~U1088AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213070	11/26/2003	CA	4.0	4		M	11/13/2003	On 9/13/03, 4 x 11cm area of erythema, 7 x 9cm area induration, 4 x 6cm central clearing area with tiny papules noted left lateral thigh per Dr. C/o bilateral hip discomfort, fever (T 99.0), malaise, nausea, vomiting.									Y	11/10/2003	11/11/2003	1	NONE	PVT	OTH	NONE	Ongoing mild cough for 2 weeks	Achrondroplaysia			1						1	Discomfort; Injection site erythema; Injection site induration; Malaise; Nausea; Pyrexia; Rash papular; Vomiting	DTAP~SANOFI PASTEUR~C1527AA~5~~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1264AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W0703~4~~RL~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0178N~2~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0213071	11/26/2003	CT	14.0	14		F	11/20/2003	40 hours post Pneumococcal vaccine: Temp 101.1, injection site with erythema, mild hives				Y					U	11/18/2003	11/20/2003	2		PVT	UNK		NONE	Lactose/exercise-induced bronchospasm, asthma			1						1	Injection site erythema; Pyrexia; Urticaria	FLU3~EVANS VACCINES~765796~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1212M~1~IM~LL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0213072	11/26/2003	VA	58.0	58		F	11/20/2003	Within several hours of receiving flu shot started having hives on face, back, tops of arms and legs. Also has severe itching/discomfort of both eyes. Self medicating with Benadryl PO and Visine, strongly encouraged on 11/19 to see PMD ASAP! Still has hives.									U	11/14/2003	11/14/2003	0		OTH	PVT	UNK	NONE	UNK			1						1	Eye pain; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1077AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213073	11/26/2003	NY	66.0	66		F	11/19/2003	Swollen (area of the site of injections) at the site area and even below the arm it hurt!!! Warmth and a pinkiness, 4 x 1, meandering. Then on Day 3 and for 24 hours, never-before-experienced severity of diarrhea, to dehydration and fainting twice.									Y	10/13/2003	10/13/2003	0		PUB	UNK	Niacin and aspirin, Estradiol, Progenderone	NONE	NONE			1						1	Dehydration; Diarrhoea; Feeling hot; Injection site erythema; Injection site oedema; Syncope	FLU3~SANOFI PASTEUR~765709~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~2557W~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213074	11/26/2003	MO	26.0	26		F	11/14/2003	Injection 11/10/2003 received flu vaccine.  Next day, felt run down lightheadness (Tuesday).  Friday in PM had diarrhea and nausea and felt like tongue was swelling.  Went to ER diagnosis with panic attack.  Also had one 9 days later just feels like she is getting the flu.  2nd time she had flu shot, 1st time felt bad all winter.				Y					Y	11/10/2003	11/14/2003	4	NONE	PUB	PUB	BC pills	NONE	Allergic to penicillin			1						1	Diarrhoea; Dizziness; Nausea; Panic reaction; Tongue oedema	FLU3~SANOFI PASTEUR~U1128AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213075	11/26/2003	WI	14.0	14		U		6 hours after administration, developed localized rash right arm that progressed and generalized to bilateral arms/chest/anterior thighs.  Patient complained of severe burning and pruritis.									U	11/20/2003	11/20/2003	0	NONE	PVT	PVT	Albuterol	NONE	Asthma			1						1	Pruritus; Rash; Skin burning sensation	FLU3~EVANS VACCINES~765851~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213076	11/26/2003	WA	61.0	61		M	11/20/2003	Patient developed diffuse myoclonic activity 2-5 days after vaccine with subsequent full resolution.									Y	11/12/2003	11/15/2003	3	Chem panel	PVT	PVT	Cozaan; Metoprolol; Levoxyl	NONE	NONE			1						1	Myoclonus	FLU3~SANOFI PASTEUR~U1260AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213077	11/26/2003	IL	81.0			F	11/19/2003	Redness and swelling on both arms one day after flu shot.  Treated with Benadryl, soluMedrol, Pepcid.									U	10/13/2003	10/14/2003	1		OTH	OTH	Risperdal	Tremor	NONE			1						1	Erythema; Oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213078	11/26/2003	IL	92.0			F	11/19/2003	Pruritic rash, 4 days after flu shot.  Medrol dosepak, allegra and zantac administered.									U	10/13/2003	10/17/2003	4		OTH	OTH	Vioxx	Arthritis	NONE			1						1	Rash pruritic	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213080	11/26/2003	CA	87.0	87		F	11/20/2003	Entire facial area flush on color.  Bilateral wrist redness and slightly raised.									U	11/14/2003	11/15/2003	1	NONE	OTH	OTH	Aricept; Colace; MVI; Tums; Miacalcin	Demcama BJD	NONE			1						1	Flushing; Rash erythematous	FLU3~SANOFI PASTEUR~U1078AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213082	11/26/2003	WV	71.0	71		F	11/21/2003	Length 13cm by Width 15cm.  Redness warm to touch, limited range of motion to arm.  Treatment: Medrol dose pak, Allegra 180mg, cool compresses.  Return to office if no improvement.				Y					Y	11/20/2003	11/20/2003	0	NONE	PVT	PVT	NONE	Well visit	Hypertension; Hyperlipidemia; Coronary Artery Disease			1						1	Feeling hot; Hypokinesia; Injection site erythema	FLU3~SANOFI PASTEUR~U1130AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213083	11/26/2003	MO	73.0	73		F	11/20/2003	Right deltoid started itching 11/19.  Redness, swelling and warmth.  Went to MD today 11/20.  MD prescribed Allegra 180mgm 1 daily for 4 days.									Y	11/12/2003	11/19/2003	7	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Feeling hot; Injection site erythema; Injection site oedema; Pruritus	FLU3~SANOFI PASTEUR~U1103AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0991AA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0213084	11/26/2003		4.0	4		F	11/12/2003	104.2 Temperature (the high).  Treated with Tylenol for increased temperatures.  Temperature increased and decreased for 2 days.									Y	11/06/2003	11/08/2003	2	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Pyrexia	DTAP~GLAXOSMITHKLINE BIOLOGICALS~601A2~5~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1269AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X0146~4~SC~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0296N~2~SC~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA		Influenza
0213085	11/26/2003	MI	33.0	33		F	11/21/2003	Received a phone call from patient to report that she has been having a problem with her arm since she received her flu shot on Friday 11/07/2003.  Got it about noon then went and worked a 12 hour shift.  By the time she got home it was very tender, hot and swollen.  Tried to just wait for it to get better but on Monday called her care provider and went in to get it checked on Tuesday 11/11.  Was put on Keflex three times a day and Motrin 800mg three times a day.  Went back to provider again this week and Keflex was increased to 4 times per day and Vicoden was added.  Has an EMG scheduled for 11/26.  Reports it remains swollen and if she does not take pain pills she can't lift her arm to put on deodorant or other such moves.  Will give update after she has the EMG and knows more about what's going on.				Y					U	11/07/2003	11/07/2003	0	EMG is scheduled on 11/26/2003	PUB	PUB	Depoprovera	NONE	NONE		MI2003065	1						1	Hypokinesia; Injection site oedema; Injection site warmth; Tenderness	FLU3~SANOFI PASTEUR~U1269AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213086	11/26/2003	SD	1.3	1	.3	F	11/18/2003	103.9 axillary temperature, O2 sat 92-94% on room air seizure. Follow up on 12/10/03: Date and time of first seizure after flumist administration: 11/13/2003 after 6PM, child in bed at time.  Time interval between flumist vaccination and onset of seizure: 12 hours.  The seizure was generalized in both sides of the body.  There was postictal drowsiness.  Parents report: unresponsive, eyes rolled back in head, tonic-clonic contractions of extremities lasting several minutes.  Child felt warm at 6PM given Tylenol.  Seizure lasted several minutes.  Tylenol medicine was administered before the seizure started.  Date of first clinic/ER/hospital visit for the reported seizure: 11/13/2003.  Diagnosis made by ER physician.  Non recorded in seizure activity in ER.  Diagnosis noted either on the date of first clinic/ER/hospital visit following the seizure episode or within 4 weeks afterwards: Upper Respiratory Infection; Acute Sinusitis; Acute Bronchitis; Febrile Seizure;				Y					Y	11/13/2003	11/13/2003	0	BMP normal; Sodium 134 (decreased); Bicarb 20; Glucose: 190 (elevated); Creatinine: 0.3; HgB: 11.8; WBC: 19, 100 (mildly increased); Segs 40; Bunds: 8; Lymphs: 36; Atypical lymphs: 3; Monos: 11; Head CT with contrast: normal; CXR: increased markings in right base.	PVT	PUB	NONE	Upper respiratory infection				1						1	Blood glucose increased; Blood sodium decreased; Bronchitis; Convulsion; Febrile convulsion; Laboratory test abnormal; Pyrexia; Sinusitis; Upper respiratory tract infection; White blood cell count increased	DTPHIB~SANOFI PASTEUR~U06540C~4~IM~LL~DTP + HIB (DTP + ACTHIB)~1|FLU3~SANOFI PASTEUR~U1094AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W0907~3~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0131N~1~IM~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA	Emergency room visit	Influenza
0213087	11/26/2003	CA	65.0	65		M	11/17/2003	Extreme fatigue, intestinal pain, appendix area too.									Y	11/07/2003	11/07/2003	0	NONE	MIL	OTH	Ranitadine; Zoloft; Wellbutrin	NONE	Depression			1						1	Fatigue; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213088	11/26/2003	IL	62.0	62		F		States fever that same night 23:00 10/15-next AM, arm red from shoulder half way to elbow.  Hot to touch, swollen.  Called MD office-instructed to take aspirin.  I then reported to the health department.  10/17/2003: Called client-improving decreased in redness and swelling.									U	10/15/2003	10/15/2003	0		OTH	OTH	Fosamex; Levoxyl	NONE	Allergic to codeine, tylenol/cellulitis right foot 1 year ago.			1						1	Injection site erythema; Injection site oedema; Injection site warmth; Pyrexia	FLU3~EVANS VACCINES~765854~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0257N~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213089	11/26/2003	IL	81.0	81		M	10/17/2003	Woke up next day (10/16/2003) after vaccination, right arm swollen, red, hot to touch, no fever.  Hot packed arm 2 times that day.  On 10/17/2003, arm still somewhat swollen from injection site to wrist, warm to touch, red.  Able to use arm.  10/17/2003, but could not on 10/16/2003.  Doing better today 10/17/2003.									U	10/15/2003	10/16/2003	1		PUB	PUB	Albuterol inhaler; Nebulizer with albuterol	NONE	Chronic obstructive pulmonary disorder uses O2 at night.			1						1	Hypokinesia; Injection site erythema; Injection site oedema; Injection site warmth	FLU3~EVANS VACCINES~765854~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0257N~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213090	11/26/2003	IL	61.0	61		M	10/17/2003	10/16/2003: Awakened 06:30-red band around shoulder-in afternoon, redness (deep red) to right side of chest.  Saw MD 15:00 10/16/2003.  Did not receive any prescription.  10/17/2003, redness increased to left side of chest.  Up to arm pit.  Stopped to see nurse in MD office-she suggested taking Benadryl 1 tab every 4-6 hours.  No improvement at this time 15:45, 10/17/2003.									Y	10/14/2003	10/16/2003	2	NONE	PUB	PUB	Proscan; Metoprolol; Nexium; Multivitamin; Vitamin C; Vitamin E; Hytrin;	NONE	Allergy to PCN.			1						1	Erythema	FLU3~EVANS VACCINES~765854~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0257N~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213091	11/26/2003	OH	49.0	49		F	11/19/2003	Evening of shot very tired and achy.  11/06-site of shot red and sore, size of 2 inch diameter.  Morning of 11/07, red rash on chest at base of throat to breasts.  Itching on neck, arms, shoulders.  Called MD to report. Purchased generic Benadryl, took twice and itching and rash went away.  Knot in arm where shot given gone by 11/09.  First time I had flu shot. Follow up on 12/08/2003: Unknown to me, please contact health department.									Y	11/05/2003	11/07/2003	2	NONE	PUB	PVT	NONE	NONE	Mitral Valve Prolapse; Hypoglycemia; Chronic obstructive pulmonary disorder			1						1	Erythema; Fatigue; Injection site erythema; Injection site mass; Injection site pain; Pain; Rash	FLUX~UNKNOWN MANUFACTURER~90658~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213092	11/26/2003	CA	2.0	2	.4	M	11/14/2003	Sudden onset within 10-15 minutes or vomiting, chills, myalgia, and general malaise that lasted 36-48 hours.  This information was given to me over the phone by mom-I did not see him.									Y	11/12/2003	11/12/2003	0	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Feeling cold; Malaise; Myalgia; Vomiting	FLU3~SANOFI PASTEUR~U1133AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0178N~2~SC~LL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|TYP~SANOFI PASTEUR~W13662~1~IM~LL~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0213093	11/26/2003	CA	60.0	60		F	11/20/2003	Injection at 15:00 by 17:00 dull pain up arm to neck with headache by next AM, patient so weak she could not move also pain to entire body, taken to ER.				Y					Y	11/11/2003	11/11/2003	0	Testing done at hospital	PVT	PVT	Prempro; Levocyl	NONE	Codeine, Streptomycin			1						1	Asthenia; Headache; Hypokinesia; Pain	FLU3~EVANS VACCINES~765753~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0213095	11/26/2003	CA	40.0	40		F	11/19/2003	Left shoulder redness, pain, warmth.  Possible cellulitis.  Keflex 500mg 4 times a day for 7 days.									Y	11/15/2003			NONE	OTH	OTH	NONE	NONE	NONE			1						1	Cellulitis; Feeling hot; Injection site erythema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213096	11/26/2003	OH	51.0	51		M	11/20/2003	Approximately 48 hours after vaccine administration patient experienced red splotches on chest with itching.  72 hours later, the red splotches increasing as welts increased intensity of itching.  Feeling hot, slight headache.  Temperature 97.6 F (oral), Blood pressure 107/70.				Y					U	11/17/2003	11/19/2003	2	NONE	PUB	PUB	Triclor; Celebrex, Clarinex	NONE	Seasonal allergies to grass, pollen			1						1	Blood pressure decreased; Erythema; Feeling hot; Headache; Pruritus; Rash maculo-papular; Urticaria	FLU3~SANOFI PASTEUR~1270AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213097	11/26/2003	CO		47		M	11/17/2003	Erythema, pain shot site.  Extending an area of 8 inches.  Also had tinuitus and fatigue.									Y	11/15/2003	11/15/2003	0	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Fatigue; Injection site erythema; Injection site pain; Tinnitus	FLU3~SANOFI PASTEUR~U1130AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0287N~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213100	11/26/2003	IL	80.0	80		F	11/14/2003	hives.									Y	10/07/2003	10/09/2003	2	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1267AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213101	11/26/2003	NE	0.3	3		M	11/13/2003	Flu shot 0.5cc IM given left deltoid 10/15/2003.On 11/07/2003, mom called and stated that on 11/06/2003 took patient in to ER for a g-tube replacement-they noticed left deltoid red, swollen, warmth.  The rash was macular-papular. No axillary or cervical nodes.									U	11/05/2003	11/06/2003	1		PUB	UNK	Presently on Augmentin	NONE	Recurrent aspiyation, severe scoliosis, multiple congenital anomalies			1						1	Feeling hot; Injection site erythema; Injection site oedema; Rash macular; Rash papular	FLU3~SANOFI PASTEUR~U1074AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0820M~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213102	11/26/2003	LA	45.0	45		F	11/01/2003	November 1st while at work and before work, I felt exaberated and very dizzy.  Nov 2nd continued to feel nausea and dizzy and between legs weak, losing feeling in my legs, unable to work.  By Nov 7th, increased dizziness, increased weakness in legs and now my back and arms.				Y					U	10/21/2003	11/01/2003	11	CBC with diff; UA, BMP 11/04/2003.  MRI Brain 11/19/2003	PVT	OTH	NONE	NONE	NONE			1						1	Asthenia; Dizziness; Hypoaesthesia; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~LA~HEP B (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0213103	11/26/2003	IL	2.0	2	.5	M	11/21/2003	Generalized tonic/clonic seizure lasting 1-2 minutes while in bed with parents. No fever. Short postiltal phase. No prior history. Follow up on 12/10/03: The seizure was generalized. The pt did not have a fever. Seizure lasted 1-2 minutes.  Neurologist putting on Trileptal. Medical records states viral infection, stupor. msv				Y					Y	11/18/2003	11/21/2003	3	CBL: Normal; Electrolytes: Normal; CT-Head: Normal;Pt underwent a resting 19-channel EEG w/added channels of EKG and respiratory rhythm activity.  No ECG or respiratory abnormalities were seen.  There was a 6 to 7 Hz medium voltage, posterior basic rhythm that occasionally reached 6 Hz.  There were normal awake and asleep background rhythms seen.  No focal slowing was seen.  There were frequent sharp waves and rare spikes accompanied by after-going slow waves that were maximal over the left anterior temporal central regions.  No organized seizure activity was seen.  No ECG rhythm abnormalities were seen.  No hyperventilation was performed.  No abnormalities were seen with photic stimulation.  IMPRESSION: Moderately abnormal EEG indicative of a potential epileptogenic focus that was maximal over the left anterior temporal central regions.  Clinical correlation is advised.	PVT	PVT	NONE	Diaper rash; Peri-uritherma erythema Medical recordss state increased cough. msv	Expressive speech delay			1						1	Convulsion; Stupor; Viral infection; Convulsion; Electroencephalogram abnormal	FLU3~SANOFI PASTEUR~U1094AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1094AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0213114	11/26/2003	CA				U		Behavior-emotional outburst (no treatment). Normally get flu like symptoms that are controlled with ibuprofen.  I took 3 200mg tablets at 11:00 and 22:00 day of vaccination.									Y	11/20/2003	11/21/2003	1	NONE	UNK	UNK	Ibuprofen (see #7)	NONE	NONE			1						1	Abnormal behaviour	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213143	11/26/2003	VA	44.0	44		F	11/26/2003	I received the flu vaccine on Tues. 11-25-2003. The following day, Wed. 11-26-2003, I was very sick. I had the symptoms of the flu(whole body aches, feverish, congestion in head) except I was also vomiting. I am still very achy and feverish. I have had the flu vaccine before but I have never any symptoms from it. I don't know if this was a coincidence or if I got sick from the vaccine. I called the physicians office and was told that they had had several reports of this after the vaccine was administered and there was nothing they could do, they advised to get bed rest, take something like acetominiphen for pain and drink lots of fluids. So now I wonder if something is wrong with the vaccine. I don't know how many people have gotten sick from it.									Y	11/25/2003	11/26/2003	1	I think I will recover but I am still sick.	PVT	PVT	Atenolol 50mg and Valium 5mg. Valium had not been taken that day.	I had had a migraine headache but was getting over that at time of flu vaccine.	Am allergic to penicillin and sulfa antibiotics.			1						1	Influenza like illness; Nasal congestion; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213144	11/26/2003	LA	43.0	43		F	11/26/2003	Started about 5pm yesterday, pain, redness, swelling, warmth, 1 inch from injection site, Red redness 8X15 cm; low grade fever (99.3).  Tx. Extra strength Tylenol , cold packs  Returned to clinic  this am for further evaluation and to report occurence.				Y					U	11/25/2003	11/25/2003	0		PVT	PVT	Argin-Max (supplement), Lisinopril 10 mg, Zanaflex, Aspirin, Chlorpheniramine (daily)	No	Shellfish (oysters, crabs); hypertension, back pain, obesity			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~u1074AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0944n~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0213147	11/26/2003	MT	9.0	9		M	11/26/2003	Patient fainted several minutes after getting the shot.  In the fall, the patient tore his ear and the doctor used glue to repair it.				Y					Y	11/18/2003	11/18/2003	0		PVT	PVT			Allergy to Bactrim			1						1	Injury; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0213150	11/26/2003	FL	39.0	39		F	11/26/2003	Client complained of discomfort when vaccine injected from vaccine not the needle stick.  Within 30 minutes presented with arm at site of injection red/swollen/warm with redness radiating up shoulder and neck. No SOB at this point. BP132/84. Benedryl 50mg IM in opposite deltoid and cold compresses applied to injection site.  Fifteen minutes post Benadryl complains of nausea/dizziness,slight SOB sensation. BP120/82 P88; redness on neck reduced in size/color. Unable to locate family to transport client, PMD called and advised EMS transport. Approx. 70min. after injection client transported to hospital. Redness in all sites reduced and site swelling slightly reduced.  Follow-up conversation on 11/26/03 with client who reports spent several hours in ER due to fluctuation in BP. Received IV fluids while there. Seen two days after incident in PMD office; was advised not to take flu vaccinations in the future. Client reports slept most of weekend after vaccination which is out of ordinary for her.  Returned to work on 11/24 still feeling fatigued.  However, by time of follow-up conversation was feeling fine.				Y					Y	11/19/2003	11/19/2003	0	NONE PERFORMED	UNK	PUB	NONE	DENIED	NONE INDICATED			1						1	Discomfort; Dizziness; Dyspnoea; Injection site erythema; Injection site swelling; Injection site warmth; Nausea	FLU3~SANOFI PASTEUR~U1147AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213151	11/26/2003	CO	29.0	29		F	11/26/2003	Onset of severe HEADACHE on 11/09/03 after Flu Vaccine on 10/29/03 Ultimately she had MRI(brain) CT (brain), ER visits *3+ ,Hospitalization with LP. Still has residual HA although is less and she is able to partially function. The medical records state visual disturbance and dizziness. 60-day follow up on 02/05/04 and 02/09/04: Pt has not recovered from adverse events. Persistent headache.				Y	Y	3			N	10/29/2003	11/09/2003	11	MRI brain CT brain CBC Chem Lumbar Puncture;Labs abnormal.	PUB	PUB		None	None			1						1	Dizziness; Headache; Laboratory test abnormal; Visual disturbance	FLU3~SANOFI PASTEUR~U1126AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0213152	11/26/2003	TX	47.0	46		F	11/26/2003	This patient was vaccinated with the flu shot by another nurse/friend.  It was a on a Monday or Tuesday (Oct. 20 or 21) that she was given the shot, and towards the end of the week, she began feeling unusual symptoms such as weakness, back and leg pain, feeling ill, and numbness in arms and legs.  The Sunday after she had the shot, she came home from work and was not feeling like herself.  That afternoon, she collapsed and was paralyzed.  She was taken to the Hospital to have tests done the following day.  Early the next morning, she was unable to breathe and was then airlifted to the Hospital.  She was then put on a respirator, and was then diagnosed with Guillain Barre Syndrome.  She was taken into another Hospital on October 27, 2003, and is still currently in ICU.  She is still unable to breathe on her own, and also had a tracheostomy done on her.  She can move her head and shoulders somewhat, but is still unable to move anything else. The medical records received on 1/12/04 states respiratory failure. The medical record received on 3/23/04 states basilar atelectasis, decubitus ulcer, anemia, depression and urinary tract infection. She is still paralyzed and cannot fully move on her own. She can move her right arm, but without much control. She was just moved to a long term Rehab Center as of February 2, 2004.			Y	Y					N	10/20/2003	10/26/2003	6	Gram neg rods urine culture.	UNK	UNK	Celebrex, do not know of any others.	None	Low back pain, arthritis.			1						1	Anaemia; Apnoea; Asthenia; Atelectasis; Back pain; Depression; Dyspnoea; Guillain-Barre syndrome; Hypoaesthesia; Loss of consciousness; Malaise; Pain; Paralysis; Skin ulcer; Urinary tract infection; Urine abnormality	FLU3~PFIZER\WYETH~~UNK~~UN~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Life Threatening	Influenza
0213153	11/26/2003	FL	50.0	50		M	11/26/2003	Pt received a flu shot (Fluzone,lot # U1147AA, 0.5ml/IM/Rt. Deltoid) at approximately 07:45am.  Client had reported receiving previous flu shots and denied allergies at time of administration.  Approximately 2hrs later, at 09:50am, presented at the Health Dept., stating his co-worker noticed his lip was swollen.  Client's supervisor sent him the the HD for follow-up.  Client was in no discernable distress, and apart from a swollen lower lip, showed no other allergic signs or symptoms.  The above-named MD examined pt and ordered Benadryl 50mg, IM, which was given at approximately 09:55am.  Client was instructed to remain at HD for 30 min. for further observation, and left without further incident at 10:25am.									Y	11/10/2003	11/10/2003	0	N/A	UNK	UNK	None	Denied	Denied			1						1	Face oedema	FLU3~SANOFI PASTEUR~U1147AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213155	11/26/2003	OK	31.0	31		F	11/26/2003	Vaccine administered early afternoon of 11/25/03. In late evening, I had an asthma attack. I feel general achiness today but have no fever and do NOT feel sick. Each (especially the asthma attack since I have had asthma for years and don't know for sure what set it off) could be coincidental. At this point, the asthma attack has long passed. I am still a bit achy, but it is not severe. Mild aches in arms, legs, back, buttocks, etc. It feels like how I think I would feel if I had never exercised and then worked out for an hour.  In regard to the asthma attack, at the time, I had no epinephrine on hand, which has stopped my worst attacks dead in their tracks. I used a little too much of my albuterol inhaler, but the attack did subside without my having to administer epinephrine or visit the ER.  I have completely recovered from the asthma attack, and it seems that my achiness has improved somewhat over the course of today, so I expect it will be gone soon. Therefore, I am marking yes on question #9.  Also, in regard to question #13, I am not sure about the route, but I suspect it was intramuscular. I list 9 as # of previous doses, as I have received flu vaccine every year for AT LEAST the last 10 years.									Y	11/25/2003	11/25/2003	0	none	PUB	PUB	Metformin, zyrtec, proventil inhaler, birth control pill	none	asthma, mainly due to allergic reactions; non- diabetic insulin resistance (which may have resolved by now)  I have NO food allergies that I am aware of, but I have numerous environmental allergies- various plant. tree, grass pollens, molds, animals, dust mites, etc.			1						1	Asthma; Pain	FLUX~UNKNOWN MANUFACTURER~unknown~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213156	11/27/2003	GA	47.0	48		M	11/27/2003	I RECENTLY GOT A FLU SHOT ON 11/04/2003. A COUPLE OF WEEKS LATER, I DEVELOPED A CRONIC ACHING PAIN IN MY RIGHT SHOULDER (SAME ONE WHERE I GOT THE SHOT) THAT CONTINUES TO THIS DAY.  THE PAIN IS SIGNIFICANT ENOUGH THAT IT KEEPS ME FROM BEING ABLE TO SLEEP AT NIGHT WHICH RESULTS IN LOST TIME AT WORK.  I HAVE BEEN GETTING FLU SHOTS NOW FOR THE PAST 3 YEARS.  I EXPERIENCED A SIMULAR PROBLEM IN THE PAST BUT NEVER MADE A CONNECTION TO THE FLU SHOT. I HAD AN ACHING PAIN IN MY RIGHT EAR AND JAW THAT LASTED FOR 60-90 DAYS. IT APPEARS THAT THIS PAIN IN MY SHOULDER WILL LAST JUST AS LONG.  EVERTHING THAT I HAVE READ SAYS THAT THE FLU SHOT CAN CAUSE ACHES AND PAINS FOR 2-3 DAYS. I WANT IT TO BE ON THE RECORD THAT THEY CAN LAST FOR SEVERAL MONTHS.  I AM NOT ALLERGIC TO EGGS.  I WILL NEVER GET ANOTHER FLU SHOT. I WOULD RATHER DIE FROM THE FLU THAN SUFFER THE PAIN.									U	11/04/2003				UNK	UNK						1						1	Ear pain; Pain in jaw; Shoulder pain; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213157	11/28/2003	CO	8.0	8		F	11/28/2003	PT BROUGHT IN 24 HOURS POST INJECTION WITH LOCAL REACTION OF 3 X 5 PATCH RED RAISED HIVES OVER RIGHT DELTOID AND PRURITIS AT SITE.  NO RESPIRATORY S/S.				Y					Y	11/24/2003	11/25/2003	1	NOT APPLICABLE	PUB	PUB		ASTHMA MAINTENANCE F/U (CONTROLLED)	REACTIVE AIRWAY DZ (ASTHMA)			1						1	Injection site hypersensitivity; Injection site reaction; Pruritus; Rash erythematous; Urticaria	FLU3~SANOFI PASTEUR~766051~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0863N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0213158	11/28/2003	CA	46.0	46		F	11/29/2003	FATIGUE, SORE THROAT, VERTIGO/DIZZINESS, HEADACHE.   RESTED, DRANK FLUIDS, TOOK TYLENOL FOR 24 HOURS AFTER ONSET OF SYMPTOMS.   SYMPTOMS STARTED WITH FATIGUE AND SORE THROAT AROUND 9PM ON 11/21 (DATE OF VACCINE) AND I WOKE UP ON 11/22 WITH VERTIGO/DIZZINESS/HEADACHE AND THOUGHT I WOULD FAINT IF I TRIED TO GET OUT OF BED. SYMPTOMS RESOLVED BY THE TIME I WOKE UP ON 11/23									Y	11/21/2003	11/21/2003	0	NONE	UNK	PVT	BEXTRA 20MG		HERNIATED DISC WITH EPIDURAL INJECTION ON 11/11/2003.			1						1	Dizziness; Fatigue; Headache; Pharyngolaryngeal pain; Vertigo	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0213160	11/29/2003	NH	3.0	3		F	11/29/2003	Pt received her second flu shot on 11/26/03 at 2:45.  Her first shot was received one month earlier (this was her first year with the flu shot).  After her first shot she seemed to have a wheeze, but we all assumed it was a cold.  After the second flu shot, she woke up at 3:00 on 11/27/03 with a strange sounding cough.  She coughed all day and seemed tired.  Again we assumed she was coming down with a cold.  At 7:30 pm I noticed she was breathing funny.  At 10:00 pm we noticed her breathing was even worse and labored.  We immediately called the on call physician from Medical Office and then rushed her to Hospital. Doctors in the ER advised she was in respatory distress.  She was placed on a nebulizer for 3 treatments, given steroids orally, and received a chest x-ray to rule out pneumonia.  After being stabilized she was discharged from the hopsital at 2:30 am on 11/28/03.  It is suspected that Arianna may be allergic to something on the list that would indicate she should not get flu shots.  She will be tested for allergies shortly to help us determine what it is she may be allergic to.  We know it is not eggs.  Pt will be on oral seroids for the next 3-5 days and now has an inhaler.				Y					Y	11/26/2003	11/27/2003	1	Chest X-Ray	PVT	PVT	None	None	None			1						1	Cough; Dyspnoea; Respiratory disorder; Respiratory distress; Wheezing	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0213161	11/29/2003	TX	38.0	38		F	11/29/2003	Redness and swelling since vaccination limited to vaccination area less than 1 cm wide. I have applied neosporin.  Vaccination administered at work through Centro Med and paid by employer.									U	11/18/2003	11/18/2003	0	none	UNK	UNK	none	none	none	rednessa and swelling~Influenza (Seasonal) (no brand name)~~38.80~In Patient		1						1	Injection site erythema; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213162	11/30/2003	PA	3.0	3		F	11/30/2003	Influenza vaccine administered on 11/28/2003 at 3:30 pm.  Patient developed spreading erythema, induration, pain and warmth at intramuscular injection site (left anterior thigh)first noticed on 11/29/2003 at 9:30 am.  Oral Augumentin started on 11/29/2003 at 11:30 pm.				Y					U	11/28/2003	11/29/2003	1		PVT	PVT	none	none	none			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~1~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0213163	11/30/2003	AZ	75.0	75		M	11/30/2003	Vaccine Administered 9:30 AM Nov 28 Developed sore throat, cough, and headache two hrs later. Condition worsened during day. Experienced intermittent pain in neck, arms, legs. Developed red rash on buttocks.  Applied anti itch ointment, and antibiotic cream. No benefit. Condition same Nov29. Took 50 mg Benadryl every 4 hrs. Took two Tyanol. Condition about same on Nov 30 Slight improvment in headache, no change in rash, cough, and sore throat. Neck pain continues									N	11/28/2003	11/28/2003	0	N/A	UNK	UNK	Dilantin 300mg, Covera 180mg, Lipitor 10mg, Propecia 1mg           Taken evening every day	None	Seizures, high blood pressure, high Cholesterol			1						1	Cough; Headache; Neck pain; Pain; Pharyngolaryngeal pain; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213164	11/30/2003	CA	30.0	30		F	11/30/2003	Within about 18 hours of receiving the shot:  Hives on scalp, ears, eyelids, throat/neck, chest, hips, back, legs, wrists.  Swollen eyelids.  Chills.  Treatment:  Patient took Benadryl and used Benadryl cream before seeing the doctor (recommended by the advice nurse.)  The doctor recommended that the patient take Claritin, and the patient took the generic equivalent (Loratadine).  The treatment temporarily eased some of the itching, and the hives appeared to flatten out and spread in diameter.   As of 11/30/03: Hives are still present, large, and are even darker pink than before.				Y					U	11/28/2003	11/29/2003	1	NONE.  Patient was seen at Urgent Care on 11/29/03.	UNK	UNK	Patient had just ended a course of antibiotics (amoxicillin capsules)which she had taken on several previous occasions without any reaction.  Patient has never had any similar allergic reaction to any medication or substance. ALSO Nasarel h	Recent sinus infection, which had been treated with amoxicillin.	NONE			1						1	Eyelid oedema; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0213165	11/30/2003	AR	7.0	7		F	11/30/2003	She broke out with extreme hives all over her body. We went on vacation and had to take her to a doctor out of state 2 days after the vaccine for steroid meds and allergy meds because benadryl was not working.  When the hives started it was just a few and I called clinic after hours #.  They told me to use cortisome cream and if it got worse Benadryl. 2 days later she was worse & we ended up at a drs. office.  At that time she had also started running a low grade temp.  The pricked her finger and ran a blood test and said she had some type of bacterial infection.				Y					Y	11/22/2003	11/22/2003	0		UNK	UNK	Cefzil	She was finishing Cefzil for strep throat which she had been diagnoised with on week prior to the vaccine.				1						1	Bacterial infection; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0213103	12/01/2003	IL	2.0	2	.5	M	11/24/2003	It was reported that a 2 year old male pt received Fluzone administered IM in the right arm on 11/11/03 at 10:40 am. Three days later the pt experienced a generalized tonic/clonic seizure lasting one to two minutes while in bed with his parents. The pt did not have a fever. Short post-ictal phase. The pt has no prior history. The pt reportedly did recover from this event. From additional info received on 11/24/03 from reporter: The dose of Fluzone given wsa.25ml. This child was seen by a neurologist, who stated that the test results were coming back within normal limits. An EEG was scheduled, and the results will be forwarded. He felt the causality will be determined after the EEG report was obtained. The name and contact info of the neurologist was provided.  Follow up on 12/12/03: From additional information received on 12/08/03 from the reporting physician, the results of the EEG report were provided.  On 12/02/03, the pt underwent a resting 19-channel EEG.  The impression was moderately abnormal EEG indicative of potential epileptogenic focus that was maximal over the left anterior temporal central regions.  Clinical correlation is advised.  No other information was provided at this time.				Y					Y	11/18/2003	11/21/2003	3	Normal CBC; electrolytes, normal CT-head; 12/02/03: The pt underwent a resting 19-channel EEG with added channels of EKG and respiratory rhythm activity.  No EEG or respiratory abnormalities were seen.  There were normal awake and asleep background rhythms seen.  No focal slowing was seen.  There were frequent sharp waves and rare spikes accompanied by after-going slow waves that were maximal over the left anterior temporal central regions.  No organized seizure activity was seen.  No EEG rhythm abnormalities were seen.  No hyperventilatin was performed.  No abnormalities were seen with photic stimulation.	PVT	PVT		Diaper rash, peri-urethral erythema	Expressive speech delay		200303204	1						2	Convulsion; Stupor; Viral infection; Convulsion; Electroencephalogram abnormal	FLU3~SANOFI PASTEUR~U1094AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1094AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0213182	12/01/2003	MN	0.67	0	.7	M	11/26/2003	Mom noticed rash on stomach, back, neck, face, arms 2 days after immunization. Mother called clinic on 11/26/03 to speak to MD who instructed her not to have pt vaccinated with 2nd dose.									Y	11/20/2003	11/22/2003	2	NONE	PVT	PVT		Low grade fever, teething	Eczema			1						1	Rash	FLU3~SANOFI PASTEUR~U1264AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213183	12/01/2003	CA	61.0	61		M	11/29/2003	Pruritis and urticaria one day after Influenza vaccine. Petechiae developed over the next 24 hours to most of body except face and neck, worst on legs. He otherwise felt fine. Probable vasculitis Dx.				Y					Y	11/12/2003	11/13/2003	1	Mild anemia (13.4/40.1) and mild thrombocytopenia (140) with mild worsening of renal insufficiency (1.6 creat)	PVT	UNK	Avapro, Celebrex, ASA, multiple vitamins/minerals	NONE	Penicillin; prostate cancer, IBS, HSVI, diastolic dysfunction			1						1	Petechiae; Pruritus; Urticaria; Vasculitis	FLU3~SANOFI PASTEUR~U0193AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213184	12/01/2003	PA	73.0	73		F	11/18/2003	Noticed swelling around site and around arm 2 days after getting vaccinated. Swelling began moving down to elbow area, also had some tenderness and redness. Started to get better 11/16/03, 11/17/03. Advised warm soaks and call if no better 48 hours. Tylenol/Advil prn.									Y	11/14/2003	11/15/2003	1	NONE	PVT	UNK		Sinus congestion, some drainage	CAD, HTN, Meniere's disease, high cholesterol, +ANA, MI (1997), ASA, Ativan; allergic to Septra			1						1	Erythema; Injection site oedema; Pain	FLU3~SANOFI PASTEUR~U1089AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0947N~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213185	12/01/2003	NC	3.0	3		M	11/26/2003	Hypersensitivity to flu vaccine. Large edematous area left upper arm 14 x 13cm.									Y	11/25/2003	11/25/2003	0	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Hypersensitivity; Injection site oedema	FLU3~SANOFI PASTEUR~U1129AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213186	12/01/2003	NM	56.0	56		F	10/31/2003	Swelling, redness at site right deltoid.  Complained of body aches.  Patient was prescribed Cipro 500mg 2 times a day for 7 days.  Tylenol 500mg every 4 hours as needed.									Y	10/27/2003	10/28/2003	1		OTH	PVT	AM Lotipin; Lantus Insulin; Lasix; Zestril; Lipitor; Ultramin	NONE	Diabetes Mellitus; Hypertension; Coronary artery disease		20031101	1						1	Injection site erythema; Injection site oedema; Pain	FLU3~EVANS VACCINES~765852~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0564N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213187	12/01/2003	WA	75.0	75		F	11/20/2003	Upper arm became red, hot, itchy, hard per patient.  Now resolved.									Y	11/13/2003	11/13/2003	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site warmth; Pruritus	FLU3~EVANS VACCINES~766049~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1119M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213202	12/01/2003	SD	45.0			F		A report was received from a health care professional on 11/18/2003 concerning a 45-year-old female pt who developed transverse myelitis with numbness and weakness in the lower extremities, and paralysis from the waist down approximately 12 days after receiving Fluvirin on 10/14/2003. On 10/26/2003, approximately 12 days after vaccination the pt began to experience symptoms of numbness and weakness in the lower extremities. This progressed to the point of paralysis from the waist down. The pt was hospitalized on an unspecified date. A spinal tap and a magnetic resonance imaging scan failed to reveal an infection or any other process. The attending neurologist diagnosed the condition as transverse myelitis. The pt had not recovered at the time of the report, and remains hospitalized. There was insufficient info to determine the reporter's causality assessment. The reporter indicated that the attending neurologist informed her that she (the neurologist) would be reporting this event to CDC. Follow up pending.					Y				U	10/14/2003	10/26/2003	12	Magnetic Resonance Imaging: No infection. Spinal tap: No infection.	UNK	UNK	Concomitant drugs not reported.				200301105	1						1	Asthenia; Hypoaesthesia; Myelitis transverse; Paralysis	FLU3~EVANS VACCINES~765180~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0213209	12/01/2003	FL	26.0	27		F	12/01/2003	2 HOURS AFTER RECEIVING THE FLU VACCINE ON 11/19/03, CLIENT EXPERIENCED ITCHING AND SORENESS AT THE SITE.  ON 11/20 CLIENT NOTICED REDNESS AND SWELLING AND PAIN IN RIGHT ARM.  CLIENT SEEN IN CLINIC 11/20.  INJECTION SITE SWOLLEN, RED AND WARM TO TOUCH.  AREA APPROXIMATELY 2 INCHES WIDE.  MD WROTE PRESCRIPTION FOR KEFLEX 500MG PO TID X 10 DAYS AND BENADRYL 50 MG TID X 5 DAYS.  CLIENT WAS CALLED ON 12/1 AND REPORTS SWELLING AND REDNESS WERE COMPLETELY GONE BY 11/29.									Y	11/19/2003	11/19/2003	0		PUB	PUB	UNIRETIC, ALBUTEROL INHALER, FLOVENT, YASMINE, ASA	LOW BACK PAIN, URI	ASTHMA, HTN, GERD, LOW BACK PAIN			1						1	Injection site erythema; Injection site hypersensitivity; Injection site pain; Injection site swelling; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U1147AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213210	12/01/2003	MI	84.0	83		F	12/01/2003	PT IS ON COUMDIN AND INR LEVEL WENT UP OVER 100			Y	Y	Y	4			Y	10/20/2003	11/11/2003	22	ELEVATED INR AFTER FLU VACCINE	PVT	PVT	COUMDIN					1						1	Laboratory test abnormal; Prothrombin level increased	FLU3~SANOFI PASTEUR~U1087AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0213214	12/02/2003	IA	65.0	65		M	12/01/2003	Anaphylactic reaction and subsequent shock. ACLS Protocol: Epi, Benadryl, Solu-cortef, Atropine, Sod. Bicarb, Cricothyrotomy. The hospital discharge summary received on 1/28/04 states cyanotic, dyspnea, apneic and limpness.	Y	11/30/2003							N	11/30/2003	11/30/2003	0		PVT	PVT	Toprol XL	NONE				1						1	Anaphylactic reaction; Apnoea; Cyanosis; Dyspnoea; Hypotonia; Shock	FLU3~EVANS VACCINES~765705~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0213215	12/02/2003	MI	0.56	0	.6	M	12/01/2003	DOA 11/27/03. The autopsy states cardiorespiratory arrest.	Y	11/27/2003							N	11/26/2003	11/27/2003	1		PVT	PUB		NONE	Joubert Syndrome			1						1	Cardiac arrest	DTAP~GLAXOSMITHKLINE BIOLOGICALS~9610A2~3~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1089AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W1440~3~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~493265~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Results in Death	Influenza
0213219	12/02/2003	FL	82.0	82		M		An 82 year old male with past history of hypertension and diabetes but no prior cardiac history. He had no previous documented allergies. He had previously received flu vaccine in my office in 2001 and in 2002. He received the Fluvirin on 10/10/03. He was found at home expired with a presumed sudden cardiac death on 10/15/03. The death certificate received on 12/3/03 states cardiac arrhythmia and myocardial infarction.	Y	10/15/2003							U	10/10/2003	10/15/2003	5		PVT	PVT	Bextra; Glucotrol; Metformin; Zesteretic; Felodipine	NONE	Hypertension; Diabetes			1						1	Cardiac arrest; Myocardial infarction	FLU3~EVANS VACCINES~765180~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0213220	12/02/2003	FL	68.0	68		F		A 68 year old female with a past history of hypertension and hypercholesterolemia but no prior cardiac history. She had a documented allergy to PCN. She had also received flu vaccine in my office in 2001 and in 2002. She received her Fluvirin dose on 10/02/03. The pt was found dead at home of a presumed sudden cardiac death on 10/20/03. The death certificate received on 12/3/03 states cardiac arrhythmia and cardiac arrest.	Y	10/20/2003							N	10/02/2003	10/20/2003	18		PVT	PVT	HCTZ; KCL	NONE	Hypertension; Hypercholesterolemia; Allergy to PCN			1						1	Arrhythmia; Cardiac arrest	FLU3~EVANS VACCINES~765180~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0213221	12/02/2003	FL	84.0	84		M		An 84 year old male with a past history of diabetes but no other medical problems, no lipid abnormalities and no prior cardiac history. He had a documented allergy to Iodine. This pt had received flu shots in my office every year since 1997. He received his Fluvirin dose this year on 1/18/03. He was found dead at home of a presumed sudden cardiac death on 11/20/03. The death certificate received on 12/3/03 states sudden cardiac death.	Y	11/20/2003							N	11/18/2003	11/20/2003	2		PVT	PVT		NONE	Allergy to Iodine; Diabetes Melitus Type 2; Colon Cancer 1998; Early Alzheimer's			1						1	Cardiac arrest	FLU3~EVANS VACCINES~765180~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0213223	12/02/2003		45.0			F		An anonymised single patient print report was received from a regulatory authority on 11/19/03 concerning a 45 year old female vaccinee who experienced lupus erythematous, which was considered to be disabling, on the same day as receiving Fluvirin and Pneumovax II vaccine on 10/22/03. The vaccinee has a medical history of systemic lupus erythematous, penicillin allergy and allergic reaction to iodine, terbinafine and buprenorphine. On 10/22/03, the vaccinee experienced lupus erythematous. The vaccinee recovered 6 days later, on 10/28/03. There was insufficient information to determine the reporter's causality assessment. No follow up pending.								Y	Y	10/22/2003	10/22/2003	0		UNK	UNK	Concomitant drugs not used.		Systemic lupus erythematosus; Penicillin allergy; Allergic reaction NOS to iodine, torbinafine and buprenorphine.		PJP200301162	1						2	Condition aggravated; Systemic lupus erythematosus	FLU3~EVANS VACCINES~765312~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~HT48650~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Disabling	Influenza
0213226	12/02/2003	MI	4.0	4		M	11/25/2003	From initial information received on 11/21/03 from a pharmacist regarding an adverse event occurring in the USA, it was reported that a four year old male patient received a dose of FLUZONE, lot number, route and site of administration not reported, on 11/14/03. That night, the patient developed soreness in his arm and shoulder. The Monday following vaccination, the patient developed a local rash around the injection site, some redness to the arm down below the elbow, and generalized pain between his shoulder and elbow. By 11/18/03, the rash was spreading down to the arm and on the chest and the child complained of many aching joints. The child was taken to a physician and received prescriptions for Zyrtec and Oraped. He also had some wheezing, but does have a history of asthma and normally takes Proventil syrup. By 11/20/03, the rash was getting worse and his joints were painful and swollen down to the knees. The child also had a swollen neck and slurred speech. He was brought to the emergency room and was admitted to the hospital. The patient's recovery status was not reported.  Please note the original date of vaccine!!!  If I sent anything to you only a year ago it was because you continued to pester us about the reaction and I probably told you we have no idea.  This is the inpatient pharmacy which oversees patients coming through the E.R. and we have no continuing contact with patient.  It is a wast of tax dollars for you to continually contact us about this matter.  Patient's physician is the only one who may know.  Per 60 day follow up: 60 days someone from your office contacted me! If you will please note I contacted you 3 1/2 years ago when the incident happened. I have no clue what happened to the child. Seems this is a little late to be following up!				Y	Y				U	11/14/2003	11/14/2003	0		UNK	UNK	Proventil syrup		Child does have asthma and normally takes Proventil syrup. Child does not take Proventil full time 24-7 as per the reporter. Most of his acute episodes that need treatment are in the spring and the fall. No allergies were reported and the patient will not eat plain eggs, but can eat cake and other things made with eggs.		200303213	1						1	Arthralgia; Dysarthria; Injection site erythema; Injection site rash; Joint swelling; Local swelling; Musculoskeletal pain; Pain in extremity; Swelling; Wheezing	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0213229	12/02/2003	PA	4.0	4		F	11/23/2003	Pt woke up with rash from waist up 11/20/03. circular urticarial lesions at injection site and elsewhere. Seen in ER for worsening rash 11/21/03 and in office. Dx erythema multiforme. rx Atarax was on Benadryl. Fever 103.1 (ax) on 11/21/03. 104 on 11/22/03. The discharge summary received on 3/22/04 states vomiting, gastroenteritis, fever, abdominal pain, and runny nose.				Y	Y	1			Y	11/19/2003	11/20/2003	1	Ches tfilm abnormal	PVT	PVT			RAD, seasonal allergies, frequent sinusitis, chronic diarrhea			1						1	Abdominal pain; Erythema multiforme; Gastroenteritis; Injection site rash; Laboratory test abnormal; Rash; Rhinorrhoea; Urticaria; Vomiting	FLU3~SANOFI PASTEUR~U1264AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0213231	12/02/2003	GA	0.2	0	.2	F	11/06/2003	11/6/03 this 2 month was given flu vaccine in error. Immunization coord. was informed of this error manufacturer and immunization hotline was contacted and they advised there should be no ill effects from this but the infant would not develop antibodies from the vaccine. They advised that mom should contact such as soreness at the site of immunziation and see MD if any adverse reactions occur. She had been instructed on this and given after the vaccine literature. 11/7/03 1105am received phone call from infant's mother who states infant won't take formula. Last bottle was about 3am and she took 2oz. then she states infant had fever last night of 102.4, she gave Tylenol and fever broke. I called kidsmed and explained the vaccine error and infant's symptoms. Talked with PA, she recommended mom bring infant in to be checked. PA said infant could be getting sick with something else but needs to be checked anyway, due to vaccine error, if she was having problems. Appt. was obtained for 2pm today. Infant's mother was contacted and informed of appt. time. I explained to her that I had given pt flu vaccine in error. She stated that pt seemed okay but she just won't take her milk. Imm. coord., informed of these developments. 3pm received phone call from kidsmed requesting copy of imm. record. This was faxed to them. 305pm received phone call from Dr who saw infant. He said he was going to admit her because she needs fluids til she started eating again. He said that he didn't know whether her symptoms (not eating, decreased urine output) were from the flu vaccine of other vaccines but he was admitting her to give her fluids. Dr also stated that he didn't feel she would have any permanent damage. 11/8/03 at my request imm. coord., called medical center and talked with charge nurse on pt's floor. Charge nurse said infant was taking formula and keeping it down. She was doing well and would probably be discharged that afternoon. 11/10/03 phone call to mother of infant. Mom states baby was discharged 11/8/03 from hospital. Has a return appt with Dr. states infant is doing fine. The medical recoreds state irritable.					Y	1			Y	11/06/2003	11/07/2003	1	Labs abnormal	PUB	PUB	NONE	NONE	NONE		GA03119	1						1	Anorexia; Irritability; Laboratory test abnormal; Medication error; Oliguria; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~21883B2~1~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1114AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0799L~1~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~492854~1~IM~RL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0213232	12/02/2003	TX	10.0	10		F	11/20/2003	Unable to walk, hurts all over, loss of appetite. The medical records state sore throat, rash, weakness and headache. The medical record received on 1/28/04 states leg pain, rash and viral myalgias.				Y	Y				U	10/30/2003	11/20/2003	21	Head CT negative, LP negative, normal CBC and CMP. Labs abnormal.	OTH	PUB	NONE	NONE	Migraine			1						1	Abasia; Anorexia; Asthenia; Headache; Laboratory test abnormal; Myalgia; Pain; Pharyngolaryngeal pain; Rash; Balance disorder; Dizziness; Rash	FLU3~SANOFI PASTEUR~U1092AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1092AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0213233	12/02/2003	TN	12.0	12		F	11/24/2003	Pt presented to my office one week after her flu shot with lower extremities paralysis and loss of bladder control. She was hospitalized for one week on high dose steroids and is currently in a rehab facility. MRI of spine-transverse myelitis. Neurogenic bladder lower extremity weakness.				Y	Y	7		Y	N	11/06/2003	11/11/2003	5	MRI of spine-transverse myelitis.	PVT	OTH	Naprosyn	Muscle strain	Back pain.			1						1	Muscular weakness; Myelitis transverse; Neurogenic bladder; Paralysis; Urinary incontinence	FLU3~SANOFI PASTEUR~U1140AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0213235	12/02/2003	OH	61.0	60		F	10/30/2003	Client states had headache 7 PM 10/28/03. Took Tylenol and 1/2 Ambien and went to sleep. 10/29/03 7 PM, noticed hives on upper right arm and axilla. Complained of tender, swollen lymph glands in right axilla. Used hydrocortisone cream. 10/30/03 12:55 PM into health department to show RN the hives on right upper arm. Complains that it is swollen (arm upper) and complains that she things she is somewhat short of breath; no cyanosis noted. Encouraged her to seek medical attention in light of her increasing apprehension. Client states she felt ok to drive to physician's office. 11/17/03 Client came into health department to complete report. States that she went to the doctor's office on 10/30/03. She states that she became ill and started heaving, vomiting and hyperventilating while waiting in the lobby to be seen by the doctor. She states that they gave her solumedrol and then transported her to the hospital by emergency squad. She was kept in the hospital for one day. States no ill effects following release from hospital. The medical record received on 12/31/03 states anxiety, weakness, achy, itching, tightness in chest and nausea.				Y	Y	1			Y	10/28/2003	10/28/2003	0	NONE	PUB	PVT	Celexa; Neuronton; Vioxx; Hydrocodone; Xanax	NONE	Lower back injuries; Skin allergy to liquid thorazine; spinal stenosis; chronic back pain; GERD; depression; anxiety			1						1	Anxiety; Asthenia; Chest discomfort; Dyspnoea; Hyperventilation; Lymphadenopathy; Myalgia; Nausea; Pruritus; Retching; Urticaria; Vomiting	FLU3~SANOFI PASTEUR~U1089AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~U0864N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0213236	12/02/2003	NH	11.0	11		M	11/13/2003	Eyes rolled back into head, turned pale with blueness around lip area, lost consciousness, dizziness. Doctor called immediately, still in office. Rapid heartbeat, quickened pulse, chest pain, hard to breathe.				Y					Y	11/11/2003	11/11/2003	0		PVT	PVT	Amitriftyline HCl, Flovent	NONE	Asthma, migraine headaches			1						1	Chest pain; Cyanosis; Dizziness; Dyspnoea; Eye movement disorder; Heart rate increased; Loss of consciousness; Pallor	FLU3~SANOFI PASTEUR~U1145AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213237	12/02/2003	FL	46.0	46		F	11/26/2003	11/30/03: Sore throat, dry cover, nasal congestion, fever, chills, hoarseness, SOB, difficulty swallowing. 11/26/03: Depo Medrol ice injection. Medrol dose pack.  12/1/03: Dry cough and hoarseness. No SOB, fever or chills.				Y					U	11/19/2003	11/20/2003	1		PVT	UNK		NONE	Allergies: sulfa/Flagyl. Asthma, obesity			1						1	Chills; Cough; Dysphagia; Dysphonia; Dyspnoea; Nasal congestion; Pharyngolaryngeal pain; Pyrexia	FLU3~EVANS VACCINES~765669~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0213238	12/02/2003	CA	66.0	66		M		6 hours after shot temp went to 104, then to 105. Cold shower 104 + 1 hour. 105. Back to shower for about 5 cycles approx 10 hours. 24 hours later severe asthma-like attack for about 4 hours, then cleared up.									Y	11/17/2003	11/17/2003	0		OTH	PUB		NONE	NONE			1						1	Asthma; Pyrexia	FLU3~SANOFI PASTEUR~U114288~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0648N~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213239	12/02/2003	WI	23.0	23		F	11/24/2003	Swelling of left arm; dizziness, numbness around the mouth, decrease in blood pressure. Tx: Benadryl 25mg po x 2. Cold pack.									Y	11/21/2003	11/21/2003	0	NONE	PVT	UNK	NONE	NONE	Bipolar disorder.			1						1	Blood pressure decreased; Hypoaesthesia; Injection site oedema	FLU3~SANOFI PASTEUR~U1266AA~1~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213240	12/02/2003	NE	48.0	48		M	11/18/2003	Hives: pt now remembers he had this same reaction to the injection years ago, not as bad.									Y	11/03/2003	11/03/2003	0		PVT	OTH		NONE				1						1	Urticaria	FLU3~SANOFI PASTEUR~U1267AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213241	12/02/2003	AZ	42.0	42		M	11/17/2003	Hives, to mouth, hands, feet and upper back of legs.									Y	11/12/2003	11/13/2003	1		PUB	OTH		NONE	Hay fever; allergic to penicillin			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1148BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213242	12/02/2003	NC	37.0	37		F	11/14/2003	Chills, weakness - congestion. Visit to Dr revealed viral; no meds, Nasocort nasal spray. II episode chills and weakness 11/13/03.									Y	10/10/2003	11/07/2003	28		PVT	PVT	NONE	NONE	NONE			1						1	Asthenia; Chills	FLU3~SANOFI PASTEUR~U1253AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213243	12/02/2003	NC	42.0	42		F	11/20/2003	Sore throat, loss of voice, fever up to 104, malaise lasted 7 days. Treated with Zithomax.									Y	10/10/2003	10/17/2003	7		PVT	PVT	NONE	NONE	NONE			1						1	Aphasia; Malaise; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U1253AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213244	12/02/2003	NC	46.0	46		F	11/20/2003	Loss of voice, shortness of breathe, chest pain, fever, weakness, malaise. Treated with Zithromycin (Z-pack) x 2.									Y	10/13/2003	10/17/2003	4		PVT	PVT	NONE	NONE	NONE			1						1	Aphasia; Asthenia; Chest pain; Dyspnoea; Malaise; Pyrexia	FLU3~SANOFI PASTEUR~U1253AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213245	12/02/2003	NY	94.0	94		F		Temperature, felt very weak, food repulsive: following morning, lasted all day. Felt slightly better next day.									Y	10/01/2003	10/02/2003	1		OTH	UNK	Synthroid, Triampterine, Ocuvite	NONE	Penicillin			1						1	Asthenia; Decreased appetite; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213246	12/02/2003	MA	69.0	69		F	11/21/2003	Day after vaccine, redness, heat, pain, itching. On 2nd day redness 17 x 9cm, tender, decreased with antihistamine.									Y	11/18/2003	11/19/2003	1		PVT	PVT			Augmentin leads to diarrhea			1						1	Erythema; Injection site warmth; Pain; Pruritus	FLU3~EVANS VACCINES~765979~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1212M~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213247	12/02/2003	NJ	69.0	69		F	11/28/2003	Severely cold for approx 3 days. Completely exhausted and falling asleep early. My right arm swelled severely and couldn't be even touched lightly. Couldn't do anything but go to bed - should have called my doctor or gone to emergency ward. Anxiety. Lethargic mentally. Note: I believe both vaccines shouldn't be given at same time.									Y	11/06/2003	11/06/2003	0		PUB	UNK	Fosamax	NONE	NONE			1						1	Anxiety; Fatigue; Feeling cold; Injection site oedema; Injection site pain; Lethargy; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0213248	12/02/2003	MN	70.0	70		F		Terrible achiness, chills, mild headache. The aches and chills (on and off) lasted 3 weeks. Treatments, reflexology, acupuncture, Quartine, bedrest.									Y	10/20/2003	10/24/2003	4		PUB	PVT	Advair	Breathing problems	COPD			1						1	Chills; Headache; Pain	FLU3~SANOFI PASTEUR~U1094AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213249	12/02/2003	OK	60.0	60		F	11/24/2003	After 5 PM 11/13/03 broke out in hives - legs, trunk of body. Called PP, was prescribed Medrol dose pack (received flu shot around 10 AM 11/13/03).				Y					Y	11/13/2003	11/13/2003	0		PUB	OTH	NONE	NONE	NONE			1						1	Urticaria	FLU3~EVANS VACCINES~765852~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0213250	12/02/2003	AR	4.5	0	.6	F	11/28/2003	She had picked up virus in doctors office.  Sorry for inconvenience! Thank you.									Y	11/16/1999				PVT	PVT	NONE	NONE	NONE			1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213251	12/02/2003	NC	1.3	1	.3	F	11/20/2003	The day after patient received 1st 1/2 of her dose (on 11/13/2003) patient developed diffuse erythematous macular rash from nape of neck down her torso and extremities.  Also developed diarrhea.									U	11/13/2003	11/14/2003	1	NONE	PVT	OTH	Zyrtec and Duoneb	NONE	Allergic rhinitis and Asthma			1						1	Diarrhoea; Erythema; Rash macular	FLU3~SANOFI PASTEUR~U1230AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213253	12/02/2003	CA	2.0			F	11/21/2003	Round, red, swollen area around vaccine.									Y				NONE	PVT	OTH	NONE	NONE	NONE			1						1	Injection site erythema; Injection site oedema	DTAP~SANOFI PASTEUR~U1027AA~2~~RL~DTAP (TRIPEDIA)~1|FLU3~PFIZER\WYETH~U1069AA~2~~LL~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|HEPA~MERCK & CO. INC.~0739N~2~~LL~HEP A (VAQTA)~1	USA		Influenza
0213254	12/02/2003	PA	1.6	1	.5	F	11/24/2003	Fever (101F) for 4 days following administration.				Y					Y	11/19/2003	11/20/2003	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Pyrexia	DTAP~GLAXOSMITHKLINE BIOLOGICALS~1606AA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1111AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~UNKNOWN MANUFACTURER~1618~3~SC~LL~POLIO VIRUS, INACT. (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0213255	12/02/2003	AR	33.0	33		F	11/24/2003	Fluzone given 10/09-arm red, swollen, painful (right arm).  Lasted 3 days, stand day after injection (given in right arm)-arm swollen from shoulder to elbow and red.  Had large induration-grapefruit size.									Y	10/09/2003	10/10/2003	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U1075AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213256	12/02/2003		53.0	53		F	11/19/2003	10:10: Left deltoid (+) edema, (+) erythema (+) pain.  Administered Benadryl 50mg IM left deltoid.  11:00: Discharge to home with resolution of symptoms (-) shortness of breath, (-) no respiratory distress.				Y					Y	11/19/2003	11/19/2003	0	NONE	MIL	MIL	NONE	NONE	Percocet; Crab; Gentamycin; IVP Dye; Mushrooms; Darvon; Erythromycin; Vancomycin; Penicillin			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~EVANS VACCINES~765710~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0213257	12/02/2003	IL	70.0	70		U		Severe arm pain for 2 days (right) gradual decrease in pain for 3 weeks, still cannot sleep on affected arm, difficulty raising arm over head.									U	11/06/2003	11/06/2003	0		OTH	OTH						1						1	Hypokinesia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0213258	12/02/2003	TN	38.0	38		M	11/24/2003	He was given flu vaccine Friday 11/21/2003. He awakened on 11/22/2003 with hives on legs which then moved up progressively trunk-arms.  Cetestone soluspan 2 ce.  Deep Benadryl 25mg each 6 hours with 50mg HS.  Follow up 11/26/2003 if hasn't cleared.									U	11/21/2003	11/22/2003	1	Referred to dermatologist MD 13:50 today.  At 14:30 she gave him prescription for Atarax.	PVT	PVT	NONE	NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1136AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213259	12/02/2003	IL	30.0	30		F	11/19/2003	Symptoms: 13x20 cm area of redness, swelling, warmth and pruritis over left arm.  Occurred approximately 24 hours post vaccination.									N	11/17/2003	11/18/2003	1	NONE	MIL	MIL	NONE	NONE	Polycystic Ovarian Disease			1						1	Injection site erythema; Injection site oedema; Injection site warmth; Pruritus	ANTH~EMERGENT BIOSOLUTIONS~FAV080~5~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~EVANS VACCINES~765754~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213260	12/02/2003	MD	38.0	38		M	11/25/2003	Headache ( (1-10), Nausea: 6 hours after influenza vaccine.  No treatment, resolved 48 hours.									Y	10/30/2003	10/30/2003	0	NONE	OTH	PVT	Albuterol Inhaler	NONE	Asthma			1						1	Headache; Nausea	FLU3~SANOFI PASTEUR~U1075AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213261	12/02/2003	CA	1.6	1	.5	F	11/26/2003	Patient received DTAP #4 in left deltoid on 11/24/2003.  That evening, patient starting having redness, warmth in left upper extremity.  From 11/24-11/26 (when patient was seen at PMD), patient with increased warmth, erythema, pruritis.  In clinic, patients temperature: 100 rectally F.  Heart rate: 130; Respiratory Rate: 20-25.  Patient given Keflex.				Y					U	11/24/2003	11/24/2003	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Feeling hot; Injection site erythema; Pruritus; Pyrexia; Respiratory rate increased	DTAP~GLAXOSMITHKLINE BIOLOGICALS~574A2~4~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1291AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213262	12/02/2003	WA	43.0	43		M	11/21/2003	Left check swollen and tender.				Y					U	11/16/2003	11/17/2003	1	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Oedema; Tenderness	ANTH~EMERGENT BIOSOLUTIONS~MAV080~5~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~765757~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~W09091~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0213263	12/02/2003	MI	67.0	67		F	11/24/2003	Severe left arm pain at/around vaccine site.  Slowly improving over the last few weeks.									Y	10/24/2003			NONE	PUB	OTH	NONE	NONE	NONE			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U1124AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213264	12/02/2003	MD		39		F	11/25/2003	Experienced generalized itching (no rash) and swelling of the eyes 5 days after vaccines listed below.  Itching lasted several days.  Ocular swelling resolved in 4-6 hours.									Y	11/06/2003	11/11/2003	5	NONE	MIL	MIL	NONE	NONE	Seasonal allergies			1						1	Periorbital oedema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|JEV~SANOFI PASTEUR~~UNK~~~JAPANESE ENCEPHALITIS (JE-VAX)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0213265	12/02/2003	UT	4.0	4		F	11/21/2003	Temperature 101 orally on 11/20/2003, after day care at 16:30.  Lethargic yesterday morning.  Complained of headache, backache heart hurt.  Temperature 102 @ 6:00 on 11/21/2003 and given Tylenol then seems to feel better 10:00 on 11/21/2003.  Referral to provider of choice.  11/24/2003-lasted one day.									U	11/14/2003	11/20/2003	6		PUB	PUB	NONE	NONE	NONE			1						1	Back pain; Chest pain; Headache; Lethargy; Pyrexia	FLU3~EVANS VACCINES~766049~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~770A2~1~IM~RA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~0805M~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0213266	12/02/2003	CA	84.0	84		F	11/21/2003	Bronchitis, cough, pain in chest.  MD shook in ER, said was on the verge of pneumonia.  Antibiotics Levaquin inhaler, cough medicine (cod).				Y					U	10/23/2003	10/25/2003	2	11/17/2003 ER: Blood work, chest X-ray	PVT	OTH	Water pills; Potassium	NONE	NONE			1						1	Bronchitis; Chest pain; Cough	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0213268	12/02/2003	TX	71.0	71		F	11/19/2003	Large local reaction to right arm 10x8 cm red, raised, warm to the touch.  Treated with cold compresses, continue with Claritan and Medrol DosePak started on 11/12/2003.				Y					Y	11/11/2003	11/11/2003	0	NONE	PVT	OTH	Claritin, Lisinopril/HCTL; Harvas C; Lipitor; Paxil	NONE	Allergic rhinitis; Hypothyroidism; Hypertenstion; GERD; Hypercholesterdemia; Osteopenia; Panic Attacks.			1						1	Injection site warmth; Rash erythematous	FLU3~SANOFI PASTEUR~U1074AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0945N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0213269	12/02/2003	TX	68.0	68		F	10/23/2003	Patient complained of pain at the administration site left arm.  The next day complained of chills, arm swelling, temperature 101 (10/16/2003).  10/17/2003, treated in ER for cellulitis, temperature 103 and antibiotic administered.				Y					Y	10/15/2003	10/16/2003	1	Cellulitis left arm	PUB	PUB	Vioxx	NONE	NONE		TX03140	1						1	Cellulitis; Injection site oedema; Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~U1091AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0257N~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0213270	12/02/2003	GA	41.0	41		F	11/13/2003	Patient complained of chest pain, dizziness, and weakness on 11/04/2003 after receiving flu vaccine on 11/03/2003.									Y	11/03/2003	11/04/2003	1		PUB	PUB	NONE	NONE	NONE		GA03122	1						1	Asthenia; Chest pain; Dizziness	FLU3~SANOFI PASTEUR~U1138AA~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213272	12/02/2003	GA	58.0	58		F	11/14/2003	Started that the pain started right after shot.  Also stated that she had dizziness, headache after shot for a little while.  Complained of edema 2-3 inches below injection site and pain, pressure put on area.  No redness or fever.  Continues to have these symptoms 1 month after injection. 12-2-03 patient stated arm much better almost back to normal.									N	10/14/2003	11/02/2003	19		PUB	PUB	Hormones and medicine for BP	NONE	High blood pressure		GA03120	1						1	Dizziness; Headache; Oedema; Pain	FLU3~SANOFI PASTEUR~U1138AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213273	12/02/2003	GA	61.0	61		F	11/07/2003	Client came into clinic 11/10/2003 with complaint of soreness and bruising.  ON exam found soreness consistent with expected side effects.  Bruise noted right deltoid approximately 1 1.2 inch in diameter.									U	11/06/2003	11/07/2003	1	NONE	OTH	PUB	NONE	NONE	NONE		GA03117	1						1	Contusion; Pain	FLU3~SANOFI PASTEUR~U1089AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213274	12/02/2003	GA	68.0	68		M	11/05/2003	Right upper arm began hurting last PM, noticed it was red and swollen this AM. Reddened, swollen, hot area inside right upper arm.  11/06/2003: patient was called and is improving.									Y	11/03/2003	11/03/2003	0	NONE	PUB	PUB	Plavix	NONE	NONE		GA03116	1						1	Injection site erythema; Injection site oedema; Injection site warmth; Pain	FLU3~SANOFI PASTEUR~U1122AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0864N~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213275	12/02/2003	GA	57.0	57		F	10/27/2003	Patient reports left arm began hurting on 10/23/2003.  Then rash began on 10/24/2003.  10/27/2003 redness and swelling noted over entire upper left arm from elbow to shoulder.  Area also hot to touch.									U	10/21/2003	10/23/2003	2		PUB	PUB	Teveteen QD	NONE	Hypertension; Allergic to PCN and ASA.		GA03115	1						1	Erythema; Feeling hot; Oedema; Pain; Rash	FLU3~SANOFI PASTEUR~U1122AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0830AA~4~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0213276	12/02/2003	UT				F	10/23/2003	Vaccine given at 12:00, patient reported flushing and feeling hot at 12:30.  Progressed to itching and localized hives.  Benadryl 150mg per mouth at 12:40.  Notified MD at 13:00.  Patient sent to clinic for follow up.									U	10/23/2003	10/23/2003	0		OTH	OTH	NONE	NONE	Allergy to penicillin and bee stings.			1						1	Flushing; Hot flush; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1122AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213277	12/02/2003	MA	59.0	59		M	11/24/2003	Severe flu-like symptoms for 12 hours.  Then, achiness every afternoon since.									Y	11/07/2003	11/07/2003	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Influenza like illness; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213278	12/02/2003	AZ	46.0	46		F	11/24/2003	Started with injection site swelling and reddening, hot to touch, pulsating.  Onset of fever-reached to 101.9 F even with taking Tylenol as prescribed.  Headache-extremely severe.  Neck and spine pain extremely severe.  Entire body extreme pain.  High fever for about 36 hours.  72 hours after injection still running 99.6 degree with headache/body pain.									Y	11/21/2003	11/22/2003	1	NONE	PVT	PVT	NONE	NONE	Fibromyalgia; Chronic rheumatic fever; Metabolic syndrome			1						1	Back pain; Headache; Injection site erythema; Injection site oedema; Injection site warmth; Neck pain; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1130AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0746AE~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0213279	12/02/2003	PA	4.0	4		M	11/26/2003	Within 3 hours of getting DTAP/IPV/Flu vaccine, his lips and face started swelling.  No respiratory distress noted, just large facial swelling and hives.				Y					Y	11/24/2003	11/24/2003	0	NONE	PVT	PVT	Singulair	NONE	Asthma			1						1	Face oedema; Urticaria	DTAP~SANOFI PASTEUR~C1624AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1145AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W1624~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0213280	12/02/2003	NC	36.0	36		M	12/01/2003	6 hours after flu vaccine had severe headache, joint pain, nausea. Lasted app 6-8 hours.									Y	11/01/2003	11/01/2003	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Arthralgia; Headache; Nausea	FLU3~EVANS VACCINES~765799~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213281	12/02/2003	CA	12.0	12		F	11/18/2003	Pt woke up morning after flu vaccine with pain/swelling at injection site. Reports both hands and feet very puffy/swollen. Unable to close hands. C/o some difficulty swallowing/some joint pain. No fever. Symptoms resolved over 25 hours with anti-histamine and pedi Advil.									Y	11/17/2003	11/18/2003	1		PUB	PUB	Albuterol inhaler, Synthroid, Claritin		Hives reaction to Sudafed.		CA030136	1						1	Arthralgia; Dysphagia; Injection site oedema; Oedema peripheral; Pain	FLU3~EVANS VACCINES~765141~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213282	12/02/2003	FL	66.0	66		M	11/26/2003	Pt developed swelling, redness to injection site with extension of erythema approximately 24 hours after Pneumovax given. Pt had no reaction to flu vaccine given in other arm.				Y					U	11/25/2003	11/26/2003	1	CBC done in office - WNL	PVT	UNK	Lipitor, Prozac, Levoxyl, Cardiazin, Fosamax, Vivsue patch	NONE	Allergic to sulfa, codeine, Monopril. Hypertension, hyerlipidemia, hypothyroidism			1						1	Injection site erythema; Injection site oedema	FLU3~EVANS VACCINES~765952~7+~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~4739~4~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0213283	12/02/2003	NY	62.0	62		F	11/06/2003	Pt received 1 dose of flu vaccine on 10/31/03. Approx 20 minutes later pt c/o numbness in lips and tightness in throat. Pt took po Benadryl and symptoms slowly subsided. Refused 911.									Y	10/31/2003	10/31/2003	0		PUB	PUB						1						1	Hypoaesthesia; Throat tightness	FLU3~SANOFI PASTEUR~U1126AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213284	12/02/2003	OR	59.0	59		M	11/21/2003	Fri 10/31/03 and Sat 11/1/03: Extreme fatigue; Sun 11/2/03 Upper resp Sx develop, throat pain (Hx every severe case of pertussis in 2001), much like with pertussis. 11/4/03 physician visit, checked out OK, just head congestion and throat discomfort. No fever or chills. Sx continue thru 11/5-8 (missed work) non-productive cough, head and throat congestion. Resolved now other than continues to have tight throat with some discomfort, (Redness and pain at site of injection for 10 days).				Y					Y	10/29/2003	10/31/2003	2	No testing done, but severe pertussis with hospitalization in 2001. Significant to reaction? No reaction last year.	PUB	PVT		NONE	Hx of severe pertussis (2001) with hospitalization	sore arm~Influenza (Seasonal) (no brand name)~~57.00~In Patient		1						1	Cough; Discomfort; Fatigue; Injection site erythema; Nasal congestion; Pain; Throat tightness; Upper respiratory tract congestion	FLU3~EVANS VACCINES~765666~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0213285	12/02/2003	PA	0.5	0	.5	M	11/25/2003	RN administered dose of Synagis and dose of Fluzone (1st time for Fluzone, had Synagis one month prior, no reactions). Within 5 minutes of giving injection, infant presented with hives widespread, blotchy distribution, respiratory system unaffected, no SOB or dysporia, no wheeze. Evaluated by MD, per MD, gave infant 1/2 tsp Benadryl po at that time. MD sent infant to ER for observation.				Y					Y	11/13/2003	11/13/2003	0		PVT	PVT	Zantac, Reglan, Synagis	NONE	28 week triplet birth; borderline personality disorder; apnea; prematurity; bradycardia; reflux			1						1	Rash macular; Urticaria	FLU3~SANOFI PASTEUR~U1102AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213286	12/02/2003	PA	0.5	0	.5	M	11/25/2003	RN administered dose of Synagis and dose of Fluzone (0.25 cc) 1st time for Fluzone, had Synagis one month prior and was fine, no reaction. Within 5 minutes after giving injections, infant presented with hives widespread, blotchy distribution, respiratory system unaffected and no SOB or dyspnea or wheeze. Evaluated by MD. Per MD gave infant 1/2 tsp Benadryl po at that time. MD sent infant to ER for observation.				Y					Y	11/13/2003	11/13/2003	0		PVT	PVT	Zantac; Synagis	NONE	28 week triplet C; BPD; grade I IVH; Apnea; Bradycardia; Prematurity			1						1	Rash macular; Urticaria	FLU3~SANOFI PASTEUR~U1102AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213287	12/02/2003	OH	44.0	44		F	11/21/2003	On 11/21 left upper arm red/hot to touch and sore. Awakened with SOB and wheezing not normal for her. Note: 11/26 discussed with staff. Had baseball size hard lump, cellulitis look like it. No hives. I instructed her consider this an allergic reaction, do not take in future.									Y	11/19/2003	11/21/2003	2	NA	PVT	OTH	Verapamil, Protonix, Estradiol	NONE				1						1	Cellulitis; Dyspnoea; Hypersensitivity; Injection site erythema; Injection site mass; Injection site warmth; Pain; Wheezing	FLU3~EVANS VACCINES~765151~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213288	12/02/2003	OH	60.0	60		F	11/21/2003	Developed hives all over arms, chest, abdomen, back and thighs 3 hours after vaccination. Next day, severe SOB, wheezing. Rx by family Dr for bronchitis (2-pak).									Y	11/03/2003	11/03/2003	0		PVT	OTH		NONE	NONE			1						1	Bronchitis; Dyspnoea; Urticaria; Wheezing	FLU3~EVANS VACCINES~41102AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213289	12/02/2003	CA	54.0	54		F	11/21/2003	20 minutes after receiving the vaccine, felt lightheaded, felt like having a Bn, had diarrhea, went to ER. After lying down on gurney felt better. Had a rash, felt flushed, heat rash. Felt nauseated after sitting up. Started an IV on her. No SOB, felt like a lump in throat. Received Benadryl, Pepcid, Solucortef. Was on Prednisone and Pepcid.				Y					Y	11/18/2003	11/18/2003	0	NONE	PVT	PUB	Atenolol, Lisinopril, Triampritan/hydrochloride esthagazide	NONE	Allergies to PCN, Cefalosporin, Tetracyclin, mercury. Sensitive to Ca+ channel blocker			1						1	Diarrhoea; Dizziness; Hot flush; Nausea; Rash	FLU3~EVANS VACCINES~765880~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0213290	12/02/2003	MA	70.0	70		F	10/30/2003	Developed itchy, red eye at approx 5:30 PM on 10/23/03 which continued on 10/24/03. On 10/25/03 developed hives. On 10/26/03 developed impaired speech and difficulty swallowing. Went to hospital and was started on Prednisone. Saw dermatologist after that who increased Prednisone dosage. 11/3/03 pt recovered, no symptoms.				Y					Y	10/23/2003	10/23/2003	0	NONE	PUB	PUB	Lisinopril, Diazide, Premarin, aspirin, calcium, Vitamin E	NONE	Hypertension, penicillin allergy			1						1	Dysphagia; Ocular hyperaemia; Pruritus; Speech disorder; Urticaria	FLU3~SANOFI PASTEUR~U1102AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213291	12/02/2003	TX	52.0	52		F	11/20/2003	Received flu shot 10/28/03 left arm. 11/17/03 noticed soreness of arm muscle and redness with pea-size sore at injection site. No drainage at site. Tx: apply polysporin to site, cover with bandaid and keep clean. Use current Rx of Vioxx for muscle soreness.									U	10/28/2003	11/17/2003	20	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Myalgia; Skin ulcer	FLU3~EVANS VACCINES~765412~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213292	12/02/2003	ND	54.0	54		F	11/20/2003	Received flu shot, Fluviron, Lot #765704, 11/17/03. Came in to office 11/18/03 with a pruritic dermatitis-type rash on both arms, both legs, and abdomen. No other complaints. Had never had a problem with previous flu shots. Treating with OTC antipruritic creams and lotions.				Y					Y	11/17/2003	11/17/2003	0		PUB	PUB	Lipitor, Metform, Glucophage Nasecoq, Glucatrol XL, Norvase, Lisiniphil	NONE	NONE		ND0320	1						1	Dermatitis; Pruritus; Rash	FLU3~EVANS VACCINES~765694~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0213293	12/02/2003	PA	36.0	36		M	11/07/2003	Reports a few hours post vaccination (11/03/03) started a diffuse pruritic rash over neck, trunk and extremities. Seen at clinic on 11/4/03 Rx Benadryl 25mg QID; 11/5/03 Rx Prednisone 40mg stat. Medrol Dose Pak.									Y	11/03/2003	11/03/2003	0		OTH	OTH		NONE	NONE			1						1	Rash pruritic	FLU3~SANOFI PASTEUR~U1134BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213294	12/02/2003	NY	46.0	46		M	11/21/2003	On 11/20/2003 developed oval about 3 1/2 x 1 red, indurated, raised, itchy, tender mild, right antero lat upper arm proximal well-circumscribed lesion. Skin unbroken around injection site (Also about 2 x 1 red tender itchy lesion right mid dorsal forearm per pt. Today this lesion 1 x 2 scaly, tender mild area only.									N	11/19/2003	11/20/2003	1		PUB	PVT	Vioxx	NONE	Gross (unreadable)			1						1	Injection site induration; Pain; Pruritus; Rash erythematous; Skin ulcer	FLU3~EVANS VACCINES~765483~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213295	12/02/2003	CT	42.0	42		F	11/20/2003	I received a flu and pneumonia shot on 11/6/03 (teacher). By 11/7/04 I had flu symptoms and a red, swollen circle on arm. That evening, I had a temperature. By following AM could not move arm. Went to ER. Arm is still sore. Cellulitis. Nurse did not swab arms with alcohol prior to giving shot.				Y					U	11/06/2003	11/07/2003	1		PUB	PVT		NONE	Allergies: Advair and Zyrtex			1						1	Cellulitis; Influenza like illness; Injection site erythema; Injection site oedema; Joint range of motion decreased; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0213296	12/02/2003	VA	22.0	32		F	11/20/2003	Pt received flu vaccine (Fluvirin, Evans #766052; exp 6/30/04) at approximately 4:30 PM. Dose=.5 cc IM RA. Pt was asked to wait for 10 minutes to make sure she did not have a reaction. At approximately 4:33 PM, pt began to c/o itching and not feeling well. RN brought pt back to vaccination room. Pt's right arm exhibited a red rash. Pt c/o itching to RA, palm of R hand and back. Administered Benadryl 25 mg PO at 4:35 PM. 4:37 PM: Pt c/o difficulty breathing, H/A and dizziness. Alert and oriented x3. 4:39 PM: Administered .25ml epinephrine SQ LA. 4:44 PM: Administered .25ml epinephrine SQ RA. Had pt lay on floor for c/o dizziness. 4:45 PM: B/P=124/78, pulse=100 bpm. 4:46 PM: Paramedics arrived. Reported event to paramedics - what happened, meds, vital signs. 4:50 PM: Pt states that she is feeling better. Declined to go to ER. Signed release with EMS. Pt's rash had cleared; itching was gone. Pt states she was able to breathe easier. Paramedics auscultated breath sounds - lungs clear; Pt breathing without difficulty. Gave pt another Benadryl 25mg PO. 4:55 PM: Moved pt to White Room. Pt ambulated without assistance. Pt stated dizziness had gone away and had only a slight headache (2 on a scale of 1-10). 5:03 PM: B/P sitting 118/68, Pulse=70; Resp. regular - 0 SOB. No c/o tightness in chest. Hives on RA back and palms of RA gone. No c/o itching.  5:10 PM: Pt continue to be doing well. Asked if she would like to be checked at the ER. Pt declined. She stated that she felt fine now. Advised pt to contact her personal MD tomorrow. Also, to consult MD regarding breastfeeding after receiving epinephrine. 5:20 PM: Pt continues to do well. Husband and children present. Pt states she feels fine now and can go home. Advised pt and husband of the following: a) Pt not to drive due to medications given. b) Have Benadryl readily available; can take another dose at approximately 8:50 AM. c) If rash reoccurs or pt has difficult breathing, she or spouse are to notify EMS immediately. 5:25 PM: Offered to wait with pt while husband got car, but she stated that she parked the car and he did not know where it was. Walked with pt and her family to their car. Pt continues to state that she feels fine. Ambulating without difficulty. No SOB. No c/o itching or hives. Reiterated instructions to contact EMS should the reaction reoccur. Both pt and husband stated that understood the instructions. 7:15 PM: Called pt at home to check on status. Pt doing fine. Reminded her that she could have a reoccurrence of Sx within 24 hours. Contact MD or EMS should Sx reoccur. F/U with MD. (Last flu shot was 6 years ago).				Y					Y	11/20/2003	11/20/2003	0		PUB	PVT	NONE	NONE	Allergies: codeine, Celebrex			1						1	Dizziness; Dyspnoea; Headache; Injection site erythema; Malaise; Pruritus; Rash	FLU3~EVANS VACCINES~766052~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0213297	12/02/2003	MD	29.0	28		F	11/24/2003	Left arm has been sore since client received influenza vaccine on 10/23/03. Pt reports that it is painful to move or lift her left arm. Pt states that it feels that something inside isn't right.				Y					N	10/23/2003	10/23/2003	0		PUB	OTH	Trivora	NONE	Allergic to milk			1						1	Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~U1089AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213298	12/02/2003	MO	66.0	66		F	11/24/2003	C/o on 11/21/03 evening pain at site, warmth redness and knot. Pain up to neck, nausea went to clinic, Tx by MD. F/U with another MD on Monday. Tx with Epinephrine 0.3mg, Decadron 6 mg and 1 Percocet.				Y					Y	11/21/2003	11/21/2003	0		PUB	UNK		NONE				1						1	Feeling hot; Injection site erythema; Injection site mass; Nausea; Pain	FLU3~EVANS VACCINES~766050~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0986N~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0213299	12/02/2003	NJ	79.0	78		F	11/24/2003	Arm started to itch and sore. Welt like swelling to elbow. Lasted for 4 days then, itch and swelling disappeared. Felt achey at that time and listless. Took Benadryl after speaking with doctor on call.									Y	11/05/2003	11/05/2003	0		UNK	PVT	Zestril, Toprol, Provodrol, Cardizen, Lanodin, Coumadin		HTN, Afib, CHF			1						1	Injection site oedema; Listless; Pain; Pruritus	FLU3~EVANS VACCINES~765956~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213300	12/02/2003	MI	58.0	58		F	11/19/2003	10/27/03 PM: lump at site, sore. 10/28/03: itching, no rash. 10/29/03: Broke out with rash, hives started with left arm then spread to chest and right arm, hands, to trunk, legs. Seen in ED in PM. Taking Benadryl. Symptoms worse, returned to ED 11/5/03, given Prednisone for 5 days. Symptoms improved. Day after Prednisone stops symptoms worsened. 11/18 Seen by MD, Medrol dose pack, Allegra, Kenalog spray and cream. Symptoms improving. Skin remains red and scaly.				Y					N	10/27/2003	10/27/2003	0	NONE	PVT	PVT	NONE		Sulfa (reaction years ago)			1						1	Erythema; Injection site mass; Pain; Pruritus; Rash; Urticaria	FLU3~EVANS VACCINES~765875~3~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0213311	12/02/2003	ND	53.0	53		M	11/21/2003	11/18/2003 @ 11:00: Vaccine administered; 11/18/2003 @ 19:00: Flu-like symptoms-fever, joints ache, shortness of breath, injection site soreness.   11/19/2003: Symptoms persist; 11/20/2003: Symptoms disappear!!									Y	11/18/2003	11/18/2003	0	NONE	PVT	PVT		NONE				1						1	Arthralgia; Dyspnoea; Influenza like illness; Injection site pain; Pyrexia	FLU3~EVANS VACCINES~765485~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213326	12/02/2003	MN	36.0	36		F	11/17/2003	Hives, itching, body aches, synovitis, increased LPT's.  Developed 1 week after administration.									U	11/06/2003	11/12/2003	6	Parvovirus IgM high: 10.4 (0-0.8); Parvovirus IgG elevated: 6.3 (71.1)	OTH	OTH						1						1	Laboratory test abnormal; Pain; Pruritus; Synovitis; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213352	12/02/2003	SC	29.0	29		M	11/05/2003	Patient presented to sick call today, 2-3 days after administration of vaccine with a macular/papular eruption on both cheeks, no other location, no other know precipitating causes and first eruption-non-pustular. No other vaccine information is available.									U	10/28/2003	10/31/2003	3		MIL	MIL	NONE	NONE	NONE			1						1	Rash macular; Rash papular	FLU3~SANOFI PASTEUR~765141~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213380	12/02/2003	MD	81.0	81		F		A report was received from a health care professional on 11/19/03 concerning an 81 year old female vaccinee who experienced nausea and vomiting, and was diagnosed with pancreatitis, which resulted in hospitalization for 3 days, after receiving Fluvirin vaccine on 10/22/03. Concomitant medication taken at the time of the event included hydrochlorothiazide, potassium chloride, pantoprazole, simvastatin, fluoxetine hydrochloride, amiodipine besilate, primidone and calcium polycarbophil. On 10/22/03, the vaccinee was administered Fluvirin and later that day she experienced nausea and vomiting and was subsequently hospitalized. The vaccinee was diagnosed as having pancreatitis with a lipase level of 6,686. With bowel rest and IV fluids she improved and was discharged from hospital on 10/25/03. The vaccinee is now eating well and had one episode of pain but is otherwise feeling well. She is to maintain a low fat diet. The vaccinee had recovered at the time of the report. Following review of the patient's history and other possible causes of pancreatitis, the hospital gastroenterologist considered the pancreatitis to be likely related to the vaccine, however, there was insufficient information to determine the reporter's causality assessment. Follow up pending. Follow up on 01/15/04: Further information received from a health care professional on 01/02/04 indicated that further concomitant medication taken at the time of the event included valdocoxib.  The vaccinee has a medical history of hyperlipidemia, hypertension (for which the vaccinee was taking hydrochlorothiazide), gastroesophageal reflux disease, tremor and has allergies to ampicillin, codeine, diazepam, rofecoxib and levofloxacin.  The reporter has assessed the relationship of the vaccine to the pancreatitis as probable.  Follow up pending. Update 2, 10 February 2004: Further information received from a health care professional on 10 February 2004 indicated taht the vaccinee's initial amylase on 22 October 2003 was 1175 u/l. (normal range 30u/l-110u/1). WBC was 19/2 and by day 4, 35 October 2003, lipase was down to 90 u/l (normal range 23 u/l-300u/l). A GI scan showed mild prominence of the pancreatic head, no masses, a cyst in the left lobe of the liver and mild intrahepatic biliary dilatation. The vaccinee was also treated with antimetics. There was no recent change in the vaccinee's medication. No follow up pending, all information received.					Y				Y	10/22/2003	10/22/2003	0	Lipase level 6,686. Amylase 10/22/03 1175 u/l. CT Scan mild prominence of pancreatic head, no nausea. Cyst on left lobe of liver and mild intrahepatic biliary dilation. WBC 10/22/03 19.2.	UNK	UNK	Hydrochlorothiazide; K-Dur; Protonix; Zocor; Prozac; Norvasc; Primidone; Fibercon; valdocoxib; Bextra.		Hyperlipidemia, hypertension (for which the vaccinee was taking hydrochlorothiazide), gastroesophageal reflux disease, tremor and has allergies to ampicillin, codeine, diazepam, rofecoxib and levofloxacin.		PJP200301114	1						1	Cyst; Laboratory test abnormal; Nausea; Pancreatitis; Vomiting	FLU3~EVANS VACCINES~765485~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0213383	12/02/2003	VA	22.0	22		M	12/02/2003	Patient who received his primary smallpox vaccination on November 21, 2003. At that time he also received anthrax #1, Hepatitis B #1, typhoid, and influenza. On day 6, November 27,2003, he developed axillary lymphandenopathy and axillary pain. On day 10, November 30, 2003, he developed a fever, maximum 101.4F, along with chills. During this time, he also reports that he experienced a headache especially when coughing, he felt achy, and nausea. He went to a local Emergency Room and was given Motrin 800MG TID and told to report to Immunizations Clinic on December 1, 2003. He reports that he found the Motrin to be effective meaning that he was able to sleep. Upon arrival to Imms clinic, he was found to be afebrile. He states that he feels much better today, although his axillary is red, edematous, and painful, especially when touched or with movement.				Y					Y	11/21/2003	11/28/2003	7	NONE	MIL	MIL	none	none	diagnosed with mitral valve prolapse at age 14 years			1						1	Chills; Cough; Erythema; Headache; Lymphadenopathy; Nausea; Oedema; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~1~IM~~HEP B (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~1~SC~LA~MENINGOCOCCAL (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4020071~1~~RA~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~~1~IM~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0213387	12/02/2003	FL	42.0	42		F	12/02/2003	Client states began having watery eyes on 11/28/2003. Began having numbness of her mouth on 11/29 and progressed to numbness in the top of her mouth on 11/30. Reported to the clinic on 12/01/2003 with these symtoms. Was sent to the Emrgency room for evaluation. Was admitted to the hospital with a Dx of Guillian-Barre Syndrome on 12/01/2003. Discharge summary states facial paralysis, speech disorder, neuropathy. DC Summary Bell's palsy. Motor neuron disease			Y	Y	Y	2			N	11/17/2003	11/28/2003	11		UNK	UNK	Micronor RX !0/17/2003 Zyertec Rx 10/10/2003 Lindane Shampoo Rx 11/20/2003	None reported	Allergic to Blue Dye			1						1	Facial palsy; Hypoaesthesia; Hypoaesthesia oral; Lacrimation increased; Neuropathy; Speech disorder	FLU3~SANOFI PASTEUR~U1147AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0213392	12/02/2003	MO	3.0	42		F	12/02/2003	Pt experienced soreness at the site that progressed over the week after the vaccine was given.  She has not been able to lift her arm above her head without pain since the shot was given.  She has taken Ibuprofen and Tylenol as needed daily and has applied moist heat to the site.  She did see her physician about it, but no further treatment was reccomended.  There was never any redness or swelling to the site.				Y					N	10/27/2003	10/28/2003	1		PUB	PUB	None	None	None			1						1	Injection site pain; Joint range of motion decreased	FLU3~SANOFI PASTEUR~U1255AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213395	12/02/2003	MO	4.0	4		F	12/02/2003	left shoulder with warm, red swollen bump around 2 inches in diameter, mildly tender to touch at our exam but markedly increased in the ER on the night prior. Patient had been Keflex in the ER				Y					Y	11/10/2003	11/10/2003	0		PVT	PUB						1						1	Erythema; Feeling hot; Tenderness	DTAP~SANOFI PASTEUR~c1527a7~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1260aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~UNKNOWN MANUFACTURER~W1618~4~SC~LA~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0100N~2~IM~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0213405	12/03/2003	TX	61.0	61		F	03/31/2004	From initial information received on 11/25/03 from a claims representative, regarding an adverse event, it was reported that a female patient received FLUZONE, lot number and administration information not provided, on 10/22/03. An unspecified amount of time later, the patient experienced a rash and swelling in the face, which required hospitalization. The recovery status of the patient was not reported.  Follow up on 12/05/03: From additional information received on 12/01/03 from the pt, it was reported that the vaccine was administered at a drug store.  About 30 hours later, on 10/25/03, the pt developed hives all over her body, shortness of breath and difficulty breathing.  The pt was seen in the ER and was admitted to the hospital.  She was hospitalized for one day.  The pt has recovered from these events. 29Mar04: Further attempts to contact responsible physician for this case were unsuccessful. Further information is not anticipated, this case is considered closed.				Y	Y	3			U	10/22/2003	10/25/2003	3		PUB	UNK		NONE	The pt has a pacemaker.		200303239	1						1	Face oedema; Rash	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0213407	12/03/2003	OH	58.0	58		F	11/26/2003	Post influenza vaccine, optic neuritis. Admitted to hospital 11/21/03 and discharged on 11/24/2003. The medical records received on 2/3/04 states headache, loss of vision, and amaurosis fugax. Discharge summary states disorder of pupil. msv					Y	3			Y	10/26/2003	11/21/2003	26	NKDA; Fibrocystic breasts; Peripheral Neuropathy; Smoker; OSA; Periodic Leg Movement in sleep; Lichen Planus	PVT	PVT	HCTZ; Paxil; Oscal; Fosamax		Hypertension, anxiety, depression, osteoporosis, Guillain Barre syndrome			1						1	Blindness; Headache; Mydriasis; Optic neuritis	FLU3~SANOFI PASTEUR~U1133AA~7+~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0213408	12/03/2003	NY	8.0	7		F	11/29/2003	Guillain Barre syndrome. IVIG for 5 days. Follow up on 05/06/04: Final diagnosis is still Guillian-Barre Syndrome.  Diagnosis of GBS was made by neurologist.  The pt experienced other illnesses within the 4 weeks before onset of GBS symptoms, this included a stuffy nose.  The pt never had GBS or a related illness.  The pt never previously received influenza vaccination.   Nurse follow up on 05/18/04 states: weakness lower extremities, urinary incontinence Medical records states rhinitis. msv					Y	6			Y	10/08/2003	10/15/2003	7	Spinal tap; EMG. Nurse follow up on 05/18/04 states: EMG abnormal, vital capacity reduced. Medical records states csf abnormal, ERS increased. msv	PVT	UNK		NONE	NONE			1						1	Asthenia; CSF test abnormal; Guillain-Barre syndrome; Laboratory test abnormal; Red blood cell sedimentation rate increased; Rhinitis; Urinary incontinence	FLU3~SANOFI PASTEUR~U1132AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0213409	12/03/2003	OR	42.0	42		M	11/18/2003	Significant swelling and redness of the right arm, beginning at the armpit and extending down to mid forearm, anterior aspect. Dull pain +6.									U	11/16/2003	11/17/2003	1	NONE	MIL	MIL	Atenolol	NONE	NONE			1						1	Erythema; Oedema peripheral; Pain	ANTH~EMERGENT BIOSOLUTIONS~FA080~7+~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~EVANS VACCINES~765753~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213410	12/03/2003	MA	46.0			F	12/02/2003	C/O dizziness at 3am. Awoke in bed turned to side. Noticed dizziness. Mild dizziness continued states she feels well as of 1p 12/2/03-less dizziness, stuffy nose. Pt returned to work, feels improved.									U	12/01/2003	12/02/2003	1		OTH	PVT		NONE				1						1	Dizziness; Nasal congestion	FLU3~SANOFI PASTEUR~U1127AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213411	12/03/2003	MO	73.0	73		F	12/02/2003	11/13th at 11pm she received a flu shot then at 2pm she noticed that her arm was really sore, and swollen from the scapula area to below her elbow on left extremity. She states her arm was a dark red. MD stated to put cold packs on arm.									Y	11/13/2003	11/13/2003	0	NONE	PUB	PVT		NONE	NONE			1						1	Erythema; Oedema peripheral; Tenderness	FLU3~EVANS VACCINES~766050~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213412	12/03/2003	IA	58.0	58		F	12/02/2003	Felt dizzy after the vaccine but is now (at 5:25pm) feeling better.									U	12/02/2003	12/02/2003	0		UNK	UNK						1						1	Dizziness	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213413	12/03/2003	PA	3.7	3		M	11/21/2003	Received Fluzone on 10/28/03. Seen on 11/3/03 for cough, wheeze. Tx with 2-max. 11/4/03 mother report rash on trunk. Unclear if reaction was due to Abx or latex stopper of Fluzone.									Y	10/28/2003	10/31/2003	3	NONE	PVT	PVT	Xopenex, Pulmicort, Ditropan	NONE	Spina bifida, asthma, VP shunt, latex allergy			1						1	Cough; Rash; Wheezing	FLU3~SANOFI PASTEUR~U1102AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213414	12/03/2003	MN	47.0	47		F	11/07/2003	Extreme sleepiness, vision blurry, sensitive to noise, fever, joint pain, headache lasting 4-5 days. Light-headed, unable to drive for 2 days. Moving objects (such as cars) seemed to be in slow motion. Doctor visit on 10/31/03.				Y					Y	10/28/2003	10/28/2003	0	NONE	PVT	OTH	NONE	NONE	Allergic to PCN, sulfa based antibiotics	Fever, headaches, joint pain~Hep B (no brand name)~2~41.00~In Patient		1						1	Arthralgia; Dizziness; Headache; Pyrexia; Somnolence; Vision blurred	FLU3~SANOFI PASTEUR~U1139AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213415	12/03/2003	SD	45.0	45		F	11/26/2003	Patient had flu vaccine on 10/14/03. On 10/26/03, she developed numbness and tingling in feet which gradually moved up legs to waist. On 11/5/03, developed progressive weakness in legs and back spasms. On 11/3/03, she was unable to walk and had urinary retention, and was admitted. She could still move feet on admission. She was started on IV Solumedrol. Was completely paraplegic on 10/10/03. Now plasma exchange for transverse myelitis. The medical record received on 3/23/04 states burning pain. She is still paraplegic and has no movement or sensation in her legs. It is uncertain if the myelitis is due to the flu vaccine. Per annual report she remains completely paraplegic with no movement or sensation in her legs. Her last MRI 06/21/2004 showed very significant atrophy of the lower thoracic spinal cord.				Y	Y	19		Y	N	10/14/2003	10/26/2003	12	Viral titers and PCR's negative; MRI thoracic spine 11/9/03; Central cord abnormality from T7 to T11 and mildly swollen cord; CSF: High protein and high myelinbasic protein.	OTH	OTH	NONE	NONE	Mildly abnormal thyroid function test, hypothyroid.			1						1	Asthenia; Hypoaesthesia; Laboratory test abnormal; Muscle spasms; Myelitis transverse; Pain; Paraesthesia; Paraplegia; Urinary retention	FLU3~EVANS VACCINES~765180~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0213416	12/03/2003	OR	31.0	31		F	11/21/2003	10 min following adm of flu vax developed sig. area of erythema, swelling and discomfort around inj site no respiratory prob. Ice pack applied and oral antihistamine advised.									Y	11/20/2003	11/20/2003	0	NONE	PUB	PVT		NONE	NONE			1						1	Discomfort; Injection site erythema; Injection site swelling	FLU3~EVANS VACCINES~765666~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213417	12/03/2003	KS	71.0	71		F		Feet sick-couldn't sleep-28 hrs later I broke out in large hives. My Dr gave me large dose of vitamin C to stop the reaction. Two weeks later, I still have redness from the hives.									Y	11/12/2003	11/12/2003	0		PUB	UNK		NONE				1						1	Erythema; Urticaria	FLU3~SANOFI PASTEUR~U1271AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0986N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213418	12/03/2003	CA	38.0	38		F	11/21/2003	Local pain, rash on arm, progresses to palpitations, N/V, HA, diarrhea later the same day.				Y					U	11/18/2003	11/18/2003	0	NONE	PUB	OTH	Zoloft, Avandia					1						1	Diarrhoea; Headache; Injection site pain; Nausea; Palpitations; Rash; Vomiting	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213419	12/03/2003	CA	61.0	61		M	11/25/2003	Hives/irritation in groin and armpit area similar to PCN reaction.									Y	11/19/2003	11/20/2003	1		OTH	PVT	Nil	NONE	Allergy to PCN			1						1	HIV infection; Skin irritation	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213420	12/03/2003	OR	75.0	75		F	11/28/2003	4 hrs after receiving Pneumovax inj pt developed redness swelling and welts on her right arm.									Y	11/11/2003	11/11/2003	0	NONE	PVT	OTH	Premarin	NONE				1						1	Erythema; Oedema peripheral; Urticaria	FLU3~SANOFI PASTEUR~U1149BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0256N~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213421	12/03/2003	WA	44.0	43		F		Syndrome of facial ticks and altered taste began 11/17 and became recognizable as Bell's Palsy by 11/19.									U	11/12/2003	11/17/2003	5		PVT	PVT	Effexor, Yasmin, Zyrtec		Sulfa, PCN, IVP contrast media medical records states herpes simplex. msv			1						1	Dysgeusia; Facial palsy; Muscle twitching	FLU3~EVANS VACCINES~765872~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213422	12/03/2003	MO	28.0	28		F	11/17/2003	Received vaccination 11/13. Fri 11/14 late night pain and swelling left axilary. Sat 11/15 extreme tenderness and swelling lymph nodes left axillary. No fever, no rash. Injection site okay. No soreness.									Y	11/13/2003	11/14/2003	1		PUB	OTH	NONE	NONE	NONE			1						1	Lymphadenopathy; Oedema peripheral; Pain; Tenderness	FLU3~SANOFI PASTEUR~U0192AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213423	12/03/2003	MO	35.0	35		F	11/17/2003	Received vaccine 11/13 am. Fri 11/14 afternoon developed left axillary lymphadenopathy. Sat 11/15 extreme tenderness of left axillary area. No problems at shot site. Took anti inflammatory to relieve pain.									Y	11/13/2003	11/14/2003	1		PUB	OTH	NONE	NONE	NONE			1						1	Lymphadenopathy; Pain; Tenderness	FLU3~SANOFI PASTEUR~U1092AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213424	12/03/2003	TX	74.0			M	11/28/2003	Chills, fever 102, aching body.									Y					PUB	UNK						1						1	Chills; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213425	12/03/2003	OR	50.0	50		F	11/12/2003	One hour after injections developed focal L frontal headache x 6 hrs. Then experienced nausea, increased HR, flat rash on neck and chest, achiness. Painful swollen lymph nodes R axilla. Rash worse post two days, all over x/sx resolved. No Rx at ER visit.				Y					Y	11/10/2003	11/10/2003	0	Vitals WNL at ER 11/11/03, 36 hr post onset.	PUB	PUB	Ibuprofen	NONE	NONE		OR200344	1						1	Headache; Heart rate increased; Lymphadenopathy; Nausea; Pain; Rash	FLU3~EVANS VACCINES~765138~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0287N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0213443	12/03/2003		39.0			M		A report was received from a consumer on 11/21/2003 concerning a 39 year old male vaccinee who experienced seizures 2 days after receiving Fluvirin on 10/14/2003.  The vaccinee had not been vaccinated for influenza previously and has no known allergies.  Concomitant medications taken included levothyroxine sodium.  On 10/16/2003 the vaccinee experienced a seizure.  A complete work-up was conducted including blood work, magnetic resonance imaging, and electrocardiogram, the results of which were unremarkable.  On 11/16/2003 the vaccinee experienced another seizure.  Following the seizure the vaccinee presented to an ER.  Blood work and an electrocardiogram was obtained, the results of which were unremarkable.  Follow up pending.									U	10/14/2003	10/16/2003	2	Blood work: Normal; ECG: Normal; MRI: Normal;	UNK	UNK	Synthroid		NKDA		PJP200301153	1						1	Convulsion	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213447	12/03/2003	VT	43.0	43		F	12/03/2003	difficulty breathing, fast heartbeat, paleness, weakness									Y	12/03/2003	12/03/2003	0		UNK	UNK						1						1	Asthenia; Dyspnoea; Heart rate increased; Pallor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213448	12/03/2003	MO	49.0	49		F	11/24/2003	T.C. from client.  States Igot a flu shot thursday and my neck and shoulder got really sore friday  Woke up Friday AM with neck being so sore that she was unable to move it denies left arm being sore.  C/O left side to buttocks region being sore.  Taking ibuprofen every 4 hours.  Client intends to call physician.  Denies doing thing unusual thursday.  11-25-03 2:30 pm follow-up with patient - possible adverse reaction to flu vaccine - phone call placed to patient.  She stated she had seen the doctor Monday 11-24-03 and he said it was highly unlikely that the flu shot had anything to do with her sore neck and shoulder and left side of buttocks region.  Doctor ordered cyclobenate (muscle relaxer) and bestra (anti-inflamatory) Patient states she is felling better.				Y					Y	11/20/2003	11/21/2003	1		PUB	PUB					MO2003104	1						1	Joint range of motion decreased; Neck pain; Shoulder pain	FLU3~SANOFI PASTEUR~U1074AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213457	12/04/2003	NY	73.0	72		F	12/03/2003	Right arm swelled to size of egg. On 10/02 experienced numbness in left hand, tongue, and left side of mouth. On 10/4, experienced numbness in left foot and headache. Admitted to hospital on 10/4 for possible stroke. Doctor diagnosed GBS. I am having problems with eyes double vision at close range. Information from Discharge summary states GBS disproved, did show Trancent ischemic attack. msv				Y	Y	6			N	10/02/2003	10/02/2003	0	MRI; MRA; CAT; EEG	PVT	PVT	Blood pressure medicine; Plavix; Aspirin	NONE	High blood pressure; Double vision			1						1	Diplopia; Headache; Hypoaesthesia; Swelling; Transient ischaemic attack	FLU3~EVANS VACCINES~765710~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0213459	12/04/2003	WA	41.0	41		M	12/03/2003	Received shot 11/25/03 at Okubo Clinic in left shoulder (smallpox vaccine). Not primary vaccine. Also received Typhoid, tetanus booster, and had PPD placed few days prior. First noted itching at local site then feeling warm at site. Couple days later noted bumps in pectoral area on 11/30/03. Then noted back area, started itching. Also felt warm/fevered on 11/30/03. Some odynophagia and congestion on 12/1/03.				Y					U	11/25/2003	11/30/2003	5		MIL	MIL	NONE	NONE	Allergy to PCN, otherwise denies			1						1	Feeling hot; Nasal congestion; Odynophagia; Pruritus; Pyrexia; Rash	ANTH~EMERGENT BIOSOLUTIONS~FAV008~UNK~SC~~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1139AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0652H~UNK~IM~~HEP A (VAQTA)~1|SMALL~PFIZER\WYETH~4030013~UNK~~LA~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0213461	12/04/2003	AK	50.0	45		F	12/03/2003	Pt developed pain, redness and swelling approx 2 inches posterior to vaccine injection site on left deltoid, within 24 hours of injection. Pt also had persistent bleeding from needle stick.				Y					U	12/01/2003	12/01/2003	0	PT, APTT, CBC diff - all pending	PVT	PVT	Celebrex, Prevacid, OTC sinus med	NONE	History of GERD, arthritis; Allergies: morphine, codeine			1						1	Injection site erythema; Injection site oedema; Pain	FLU3~EVANS VACCINES~765144~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0213462	12/04/2003	VA	49.0	49		F	12/03/2003	Pt received flu vaccine 12/1/03, noticed hive like welts on arm right and right foot later in day. Denies SOB, diaphoresis, etc. did note ringing in ears at bedtime. No other symptoms described/noted.									Y	12/01/2003	12/01/2003	0		MIL	MIL	Pt denies	Pt denies				1						1	Tinnitus; Urticaria	FLU3~EVANS VACCINES~765757~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213463	12/04/2003	AR	22.0	21		F		A report was received from a health care professional on 11/21/2003 concerning a 21 year old female vaccinee who experienced decreased consciousness and fever and was subsequently admitted to hospital with a possible West Nile Virus diagnosis on 11/05/2003 after receiving Fluvirin vaccine on 10/22/2003.  On 11/05/2003, two weeks following Fluvirin vaccination, the vaccinee experienced decreased consciousness and fever and was admitted to hospital with possible West Nile Virus diagnosis.  The vaccine experienced several seizures while in hospital that were resistant to standard doses of IV diazep and lorazepam.  The vaccinee remains hospitalized and her seizures are controlled using propofol drip.  At the time of the report the outcome was not reported.  There was insufficient information to determine the reporter's causality assessment.  Follow up pending. The discharge summary received on 1/15/04 states chills, malaise, tics and drop attacks. Medical records states viral infection, tachycardia, encephalopathy. msv					Y				U	10/22/2003	11/05/2003	14	Positive West Nile IgG, positive mycoplasma Medical record states leukocytosis, increased SGOT. msv	UNK	UNK	Concomitant drugs not used				PJP200301151	1						1	Aspartate aminotransferase increased; Chills; Convulsion; Depressed level of consciousness; Encephalopathy; Laboratory test abnormal; Leukocytosis; Malaise; Nausea; Pyrexia; Tachycardia; Tic; Viral infection	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0213464	12/04/2003	MI	50.0	50		F	12/01/2003	Swelling and warmth with fever left arm. C/w cellulitis or severe allergic reaction 24-48 hours after administration, increasing in size - PO Biaxin at 48 hours but continued so gt IV Cipro and PO Cipro at 96 hours in ER.				Y					Y	11/18/2003	11/19/2003	1	CBC's, arm X-ray; vital signs	PVT	OTH		DM, asthma, HTN; hyperparathyroidism	PCN causes rash, codeine intolerance, cervical lumbar radiculopathy; factor VII deficiency; ITP 2; rubella			1						1	Cellulitis; Feeling hot; Hypersensitivity; Injection site oedema; Pyrexia	FLU3~SANOFI PASTEUR~U1124AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0564N~1~SC~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0213465	12/04/2003	CA	35.0	35		M	12/02/2003	About 24 hours post injection redness, succinct, itching began at injection site. In another 12 hours hives all over body. 3-4 cm induration, red, raised and itching. Treating with Zyrtec and steroid injection.									Y	11/28/2003	11/29/2003	1		PVT	OTH	NONE	NONE	NONE			1						1	Injection site erythema; Injection site induration; Pruritus; Rash erythematous; Urticaria	FLU3~SANOFI PASTEUR~U0844AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213466	12/04/2003	CA	26.0			F	12/02/2003										U					UNK	UNK						1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U1097AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213467	12/04/2003	CA	28.0	28		F	12/02/2003	Within 12 hours of vaccination injection site red, swollen itching. In about 2 hours rash, red raised areas to entire extremity, abdomen and back.									Y	11/28/2003	11/28/2003	0		PVT	OTH	BCP, Arandia	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~U1097AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213468	12/04/2003	NC	6.0	6		M	12/01/2003	The family noticed redness, swelling, tenderness about 24 hours after the vaccine around the injection site. The area really has not changed. When seen on 12/01/03, area 10 x 14cm indurated, warm, erythematous.				Y					U	11/28/2003	11/29/2003	1		PVT	PUB		NONE	Pierre-Robin GE reflux			1						1	Erythema; Feeling hot; Injection site erythema; Injection site induration; Injection site oedema; Pain	FLU3~SANOFI PASTEUR~U1088AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213469	12/04/2003	CT	46.0	46		F	11/24/2003	No arm pain at time of injection; onset of right arm pain and fever greater than 100.  6 hours after administration, took Motrin 400mg with moderate effect.  Continues to complain of arm pain, radiating to consistant 11/24/2003.  Has not taken any pain medication since; spoke to MD 11/15/2003- MD not concerned; no further MD contact since 11/15/2003; unable to determine present pain level; no fever; pain not tender to touch-deep muscular pain; no fever for last 7 days; patient did not miss any work since med administration.  Does not plan to seek further medical follow-up.  Information received via telephone call to client on 11/24/2003.									U	11/14/2003	11/14/2003	0		OTH	PVT	NONE	NONE	NONE			1						1	Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1098AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213481	12/04/2003	MA	100.0	100		F	12/04/2003	10 mins. after pt. received the flu shot she complained of chest pain.  The nurse gave her NTG. & then the pt. c/o of difficulty breathing so the nurse started the pt's O2. After approximately 2 mins. the pt became unconscious and fell to the floor.  The nurse called 911, administered 0.3 ml of adrenalin & performed CPR.  The pt. responded within 30 seconds. The EMT's arrived, took over care of the pt. & transported her to the ED.  She was in the hospital overnight in the telemetry unit & discharged the following day. The hospital discharge summary received on 12/11/03 states syncope.				Y	Y	1			Y	11/19/2003	11/19/2003	0		UNK	PUB	Toprol XLTB 24 50mg qpm Toprol XLTB 24 25 mg. qam Cipro Cystitis tabs 500 mg. po qd tylenol 500 mg prn colace 100 mg po prn ASA po 81 mg qd darvocet N 100 q 4hrs prn pain magnesium oxide po 400 mg qd lasix 80 mg po Tue. & Fri lasix 40 mg po	angina CHF syncope	allergic to allegra, prevacid, prilosec, codeine, pyridium & sulfa meds			1						1	Chest pain; Dyspnoea; Loss of consciousness; Syncope	FLU3~SANOFI PASTEUR~U1260AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0213485	12/04/2003	PA	76.0	76		M	12/04/2003	Client received an influenza vaccination on 10/21/03. On 11/8/03 he developed an upper respiratoy tract infection. His URTI resolved without treatment. He then developed shooting pains from his lower back down both posterior thighs on 11/14/03. Upon waking on 11/15/03 he experienced numbness and tingling in both of his hands and feet. He experienced progressive symmetric numbness for the next 24 hours, prompting his admission to a Hospital and then his transfer to another hospital. His symptoms continued to progress throughout 11/16/03, requiring his being placed on a mechanical ventilator. Nurse follow up on 05/18/04 states: weakness, leg pain, gait unsteady, arms weak, speech slurred, eyes droopy, difficulty swallowing. Medical records state weakness, ataxia, cough. Other correspondance states apnea.			Y	Y	Y	19			N	10/21/2003	11/14/2003	24	Head CT within normal limits lumbar puncture/CSF cultures within normal limits negative blood cultures EMG: diffuse demyelination with diffuse axonal involvement.  Nurse follow up on 05/18/04 states: wbc elevated, inr abnormal  Medical records state hematuria, urine abnormal. msv Correspondance states hypomagnesem, hypokalemia, decreased coag times.	UNK	UNK	celebrex 100mg  percocet 5/325 started 11/14/03	chronic back pain Medical records state cough, cold.	no allergies; Nurse follow up on 05/18/04 states: Neck pain, back pain.			1						1	Apnoea; Asthenia; Back pain; Coagulation time shortened; Coordination abnormal; Cough; Demyelination; Dysphagia; Gait disturbance; Guillain-Barre syndrome; Haematuria; Hypoaesthesia; Hypokalaemia; Hypomagnesaemia; Laboratory test abnormal; Leukocytosis; Pain; Speech disorder; Upper respiratory tract infection; Urine analysis abnormal	FLU3~EVANS VACCINES~44903~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0213486	12/04/2003	MD	48.0	48		F	12/04/2003	Developed dizziness and red rash to upper chest. Benadryl 50mg IM.				Y					Y	12/02/2003	12/02/2003	0	none	UNK	UNK	Elvial, Synthroid, Prilosec,Advil, Excedrin, Imitrex as needed, Tylenol Sinus as needed.	none	Graves Disease			1						1	Dizziness; Erythema; Rash	FLU3~SANOFI PASTEUR~U1271AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213487	12/04/2003	TX	40.0	40		F	12/04/2003	Received influenza vaccine on Nov 18 2002. Within  30 min developed a rash described as red blotches. No resp distress. Sought medical treatment. Continues to experience episodic outbreaks of rash. Chronic contact dermatitis vs Chronic urticaria				Y					Y	11/18/2002	11/25/2002	7		MIL	MIL	denies	denies	denies			1						1	Dermatitis; Erythema; Rash; Rash macular; Urticaria	FLU3~SANOFI PASTEUR~uo983aa~7+~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213488	12/04/2003	CA	57.0	57		F	12/04/2003	RED SPLOTCHES ON INSIDE OF ARM.  NOT AT NEEDLE POINT BUT A FEW INCHES INSIDE ARM.  REDNESS AND TENDERNESS FOR ABOUT A WK.  NOT A PROBLEM - JUST SO YOU KNOW.  NOT SURE ABOUT WHICH FLU SHOT SO ENTERED 1'ST ON LIST.									U	11/26/2003	11/27/2003	1		UNK	UNK						1						1	Erythema; Rash maculo-papular; Tenderness	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0213489	12/04/2003	OH	59.0	0	.4	F	12/04/2003	Hoarseness and sinus drainage, sore throat, no treatment so far									U	12/02/1944	12/03/1944	1	None	UNK	UNK	Lipitor, Lexapro 20 mg., Vitamin E 1000 IU, Vitamin B complex 400, multivitamin	None	Sensitive to Sulfa, Sudafed			1						1	Dysphonia; Pharyngolaryngeal pain; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213490	12/04/2003	CA	61.0	61		M	12/04/2003	Several hours after receiving the vaccine c/o numbness form neck to feet lasting couple of seconds,superficial chest pain lasting few seconds and a feeling of coldness and weakness									Y	12/01/2003	12/03/2003	2	None	UNK	PUB	Unknown	None	None			1						1	Asthenia; Chest pain; Feeling cold; Hypoaesthesia	FLU3~SANOFI PASTEUR~UI87AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213491	12/04/2003	WI	51.0	51		F	12/04/2003	I was given the PPV and the Flu shot on 12-1-2003 at 1:00pm. Within 18 hours after receiving the PPV, I noticed general muscle aches (12-2-2003). Within 36 hours(12-3-2003) I developed a fever that ranged from 99.1 to 100.0 which lasted for approximately 20 hours. Accompanying this I had severe muscle aches particularly on the side that I received the shot (right), lethargy and extreme sensitivity and pain at the point of where the shot was given.  Cold packs were used with little effect. Mild difficulty with breathing and coughing was also noted.  I took 2 alleve in the morning and 2 tylenol in the evening. I was unable to touch and move my right arm until this morning (12-4-2003).    Today I feel much better with just mild muscle aches and tenderness at the area of the shot. I do not believe this reaction was due to the flu shot because I have never reacted to the past four flu shots I received and because of the severe right sided arm pain I had.									Y	12/01/2003	12/02/2003	1	I did not seek medical treatment *** Note: check for accuracy in section 13, the only type of flu shot noted on my receipt are the inactivated influenza and pneumococcal polysaccharide vaccines.	UNK	UNK	pravachol 80mg., prozac 10mg., alleve 440mg.	none	asthma, fibromyalia			1						1	Cough; Dyspnoea; Injection site pain; Lethargy; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|PPV~MERCK & CO. INC.~~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213492	12/04/2003	LA	49.0	49		F	12/04/2003	Shot administered at 9:00 AM In November around the 12th or 13th. At 3:00 AM next morning I broke in what looked like measles from my neck to the top of my legs. It continued to worsen until 2 days later I went to a dermatologist who gave me a shot of cortisone and some cream to help the itching. If took almost a week for it to completely go away. Since nothing else in my life had changed, other than the first flu shot I've ever had, I can only assume that it was the shot.				Y					Y	11/13/2003	11/14/2003	1		PVT	UNK	Comudan Vioxx and at that time Heprin Injections	Blood clot in right lung	Osteoarthritis in L-4 down and left knee cap. Blood clot right lung allergy to tetracycline, seldane and ceclor			1						1	Pruritus; Rash morbilliform	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0213503	12/05/2003	TX	4.0	4		M	11/20/2003	Patient developed swelling, redness, and warmth to left upper arm soon after receiving vaccinatinos. Also had fever to 102. Suspected arthus reaction but could not rule out cellulitis. Treated with Clindamycin and antihistamines. MMR vaccine wsa given in the R thigh and all others in L arm. Elsewhere in the same record it is noted that per a call to the immunization clinic, their general procedure is to give DTaP and IPV in L arm, MMR in R arm and Flu/Hep A in either arm. Per annual report- I have not had contact with this patient since they were discharged from the hospital.				Y	Y	2			U	11/17/2003	11/17/2003	0	CBC and CRP normal.	MIL	MIL	NONE	NONE	Asthma; Febrile seizures			1						1	Cellulitis; Erythema; Feeling hot; Pyrexia; Swelling; Type III immune complex mediated reaction	DTAP~GLAXOSMITHKLINE BIOLOGICALS~586B9~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1270AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0152N~1~IM~LA~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~W0906~4~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0295N~3~IM~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Hospitalisation	Influenza
0213504	12/05/2003	IN	11.0	11		M	11/26/2003	Body aches, low grade fever, stomach ache, headache, sore throat which began soon after shot. Asthma attack began 11/21/03 (10 days after flu shot). (1st asthma hospitalization for this patient in 6 years.) Failed to clear after 4 days home management and oral steroid. The follow up received on 12/24/03 states URI and pharyngitis were not evident on date of vaccination. Symptoms began within 24 hrs after vaccination. Tx PCN. Later erythromycin and Solu-Medrol. VAccine provider-pcp does not expect a discharge summary will be available-overnight hospitalization.				Y	Y	1			Y	11/11/2003	11/21/2003	10	FEV, 41% expected; Throat culture; GpG; Beta; Hemolytic strep. CXR (-) in pcp's office	PVT	PVT	Advair, Singulari, Nasonex	NONE	Asthma; Allergic rhinitis; Allergic to yellow jacket.			1						1	Abdominal pain upper; Asthma; Condition aggravated; Headache; Pain; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U1266AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0213507	12/05/2003	PA	13.0	13		F	11/22/2003	Left upper arm swollen with red streak; tender to touch. Erythematous streak running anterior to axilla. Dianosis: possible allergic reaction.									Y	10/24/2003	10/25/2003	1	NONE	PVT	PUB		NONE	NONE			1						1	Cellulitis; Erythema; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U1125AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0865N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213508	12/05/2003	NY	39.0	39		F	11/26/2003	About 20 minutes after the shot, my boyfriend and I were driving home and my arm where I received the shot felt hot then my whole body felt hot. I started feeling dizzy and then passed out for approximately 2 minutes. I came to. We stopped driving so I could get some air.									Y	10/23/2003	10/23/2003	0	NONE	OTH	OTH	Birth control pill - Micornor	NONE	NONE			1						1	Dizziness; Feeling hot; Loss of consciousness	FLU3~EVANS VACCINES~765416~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213509	12/05/2003	IA	1.0	1	.0	M	11/24/2003	On 11/19/2003 mother reported that child ran fever 104-105 on 10/18/2003 and 10/19/2003 with lethargy, fever completely gone by Tuesday 10/21/2003.  Child seen both days in ER.  Mom gave Tylenol for fever.				Y					Y	10/15/2003	10/18/2003	3	Urine and CBC within normal per parent	PUB	PUB	NONE	NONE	NONE		IA03014	1						1	Lethargy; Pyrexia	FLU3~SANOFI PASTEUR~U1111A~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W09072~3~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0059N~1~SC~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|VARCEL~MERCK & CO. INC.~0207N~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0213510	12/05/2003	CO	41.0	41		F		About 10 minutes after giving flu vaccine, patient presented with red streaks on both arms and blotches around neck with generalized itching.  However patient was not in distress.  I gave her 50mg of Benadryl/Liquid checked her BP and HR 155/95 and 80bpm.  15 minutes later: 122/80 & 72bpm.  About this time MD was getting a prescription and I asked if he would look at her he felt she would be OK.  I had suggested the patient should get Benadryl and if symptoms return to take 25-50mg every 4-6 hours as needed.  MD told the patient the same thing.  I checked her BP 122/50, pulse 72.  Her red blotches and streaks were almost resolved before she left.  Patient said she was feeling better.  However after this occurred patient admitted that she had a mild reaction to a previous flu shot 2 years ago.  I told her she should not receive anymore flu shots without seeing a physician.  P.S. 12/04/2003: Called patient to get more info from her.  She informed me she had gone to the ER later on 11/20/2003 because she felt she couldn't swallow.  However they only gave her IV fluids according to patient no meds were given.  Symptoms resolved and she left 2 hours later.				Y					U	11/20/2003				PVT	PVT	NONE	NONE	NONE	Felt bad~Influenza (Seasonal) (no brand name)~~39.00~In Patient		1						1	Blood pressure increased; Cellulitis; Dysphagia; Heart rate increased; Pruritus; Rash macular	FLU3~SANOFI PASTEUR~U1254AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213511	12/05/2003	MI	6.0	16		F	12/04/2003	Within 36 hours of patient receiving flu vaccine, she had acute onset of redness of hands and feet with complaint of pain and inability to bear weight on feet. Admitted to hospital.					Y				Y	12/02/2003	12/04/2003	2	CBC with differential; ESR; CRP; Blood C&S; ANA; Rheumatoid factor; ASO titer.	PVT	PVT	NONE	Rhinorrhea, cough, loose stools	NONE			1						1	Erythema; Pain	FLU3~SANOFI PASTEUR~U1097AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0213512	12/05/2003	NY		54		F	11/24/2003	Appears to be cellulitis.  Seeing her PMD today.									U	11/20/2003	11/21/2003	1	NONE	PUB	OTH	Yes, names unknown	NONE	Latex allergy-was advised by PMD to stop before injection.			1						1	Cellulitis	FLU3~SANOFI PASTEUR~U1271AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213513	12/05/2003	MO	0.4	0	.4	M	12/01/2003	Inactivated polio vaccine ordered; inactivated influenza vaccine given (0.5mL).									Y	11/17/2003			NONE	PVT	PVT	NONE	NONE	Hydronephrosis			1						1	Drug administration error	DTAP~GLAXOSMITHKLINE BIOLOGICALS~599B9~UNK~~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1128AA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE081AA~UNK~~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~494314~UNK~~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0213514	12/05/2003	MD	69.0	69		F	11/29/2003	Discomfort in the back of both thighs, back of both knees and both calves (left worse than right).									U	11/16/2003	11/17/2003	1	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Arthralgia; Pain	FLU3~SANOFI PASTEUR~U1256AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213515	12/05/2003	MD	53.0	53		F	11/30/2003	Arm sore 3 days, then cough, severe sore throat, hot, cold sweats, headache.  11/25th vomiting, went to MD, had bronchitis, low grade fever, sick at stomach, spitting up yellow phlegm.  Gave me antibiotic and cough syrup.  11/30/2003, feel better but not 100%.  Been sick 11 days, more questionable.				Y					U	11/20/2003	11/22/2003	2	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Bronchitis; Cough; Headache; Hyperhidrosis; Pain; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea; Stomach discomfort; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0213516	12/05/2003	MD	62.0			M	11/28/2003	Significant discomfort/pain at injection site when left arm/shoulder is moved.  Arose morning after administration and still present 10 days later.									U	11/19/2003	11/20/2003	1	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Injection site pain	FLUX~UNKNOWN MANUFACTURER~~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213517	12/05/2003	SC	28.0	28		M	11/17/2003	Patient reports swelling, redness at isolated site distal to left deltoid injection site on inner aspect left arm.  Area is 2x2inch with possible punctate center.  Using NSAIDS, ice.  Area tender but no decreased range of motion, no evidence of cellulitis.									Y	11/15/2003	11/16/2003	1	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Erythema; Injection site pain; Oedema	FLU3~EVANS VACCINES~765754~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~SANOFI PASTEUR~U1011AA~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0213518	12/05/2003	NC	28.0	28		F	11/23/2003	Patient arm increased sore, feels fatigued late PM after received dose.  Right upper arm red and blotchy, swollen shoulder-elbow, unable to raise right arm next day.  Denies respiratory symptoms.  Advised to take Aleve or Ibuprofen and Benadryl as needed.									Y	11/19/2003	11/19/2003	0	NONE	UNK	UNK						1						1	Fatigue; Injection site erythema; Oedema; Pain; Rash macular	FLU3~EVANS VACCINES~765136~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0947N~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213519	12/05/2003	MN	11.0	11		F	12/01/2003	Itching all over for 12 hours.  Tired, patient reports feeling funny, tired and tongue felt funny day after shot.  No hives or swelling or tongue noted upon exam.  No egg allergy.  Afebrile.									Y	11/04/2003	11/04/2003	0	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Dizziness; Fatigue; Pruritus	FLU3~SANOFI PASTEUR~U1142AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213596	12/05/2003	MO	32.0	32		F	12/05/2003	Evening after receiving YF/HAV & Flu vaccination patient states developed fever & chills.  Contacted me the following morning and described a temperature of 37.4 C - feel better.  Did attend classes the morning following immunizations but would have stayed home if had a choice.  Also c/o mild headache - described it as a normal headache for her.  Pt was self treating with rest, fluids, and Tylenol prn. Refused provider appointment.  Advised to seek emergency care if status deteriorated.  Pt stated her husband would be home with her this evening.  Also advised her of the availability of a 24 hr nurse triage line if she had further concerns and we were closed.  She is suppose to check in with me via e-mail this AM.									Y	12/02/2003	12/02/2003	0	None done.	UNK	UNK	Allegra prn allergies. OTC analgesics prn migraine headaches. Multi-vitamin Cortisone cream prn	Patient denied any illness.	No known allergies. PMH:  Migraine Headaches & environmental allergies.			1						1	Chills; Pyrexia	FLU3~SANOFI PASTEUR~U1148AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~794A6~1~IM~LA~HEP A (HAVRIX)~1|YF~SANOFI PASTEUR~UB362AA~1~SC~LA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0213597	12/05/2003	WA	63.0	63		M	11/10/2003	No feeling of shot.  Sick 3 days after wife.  Achy, shot throbbed. Violent vomiting, tired next day, no appetite and none for next day.									Y	10/21/2003	10/29/2003	8	NONE	MIL	MIL	NONE	NONE	Heart; High blood pressure; Stent			1						1	Anorexia; Fatigue; Pain; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213629	12/05/2003	SC	12.0	12		M	12/05/2003	Child presented to clinic for flu vaccination.  following immunization, child complained of feeling faint.  Head was placed between knees.  Child then jumped up, arched back and was assisted to the floor. He regained consciousness within one minute.				Y					Y	10/15/2003	10/15/2003	0	NONE	PUB	PUB	NONE	NONE	NONE		SC0350	1						1	Dizziness; Loss of consciousness; Opisthotonus	FLU3~SANOFI PASTEUR~U1260AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213631	12/05/2003	SC	31.0	31		M	12/05/2003	Client called health department 11/25/03 to state he ahd developed 20 red hives on right hip during the late afternoon of 11/24/03.  Stated he had flu shot in am of 11/24/03.  Stated he did not call or go to private MD.  No other symptoms of fever reported.  States he applied cortisone cream to relieve his itching area of right hip.									Y	11/24/2003	11/24/2003	0		PUB	PUB	NONE	NONE	NONE		SC0352	1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1291AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213632	12/05/2003	MI	76.0	76		F	12/05/2003	HIGH INR. ACUTE DROP IN H AND H					Y	15			Y	11/13/2003	11/20/2003	7	INR 121	UNK	UNK	LEVOQUIN, VALPORIC ACID, LOPRESSOR, LISINOPRIL, PROTONIX	UTI FRACTURE TIBIA DEMENTIA CVA HTN	PENICILLIN			1						1	Haematocrit decreased; Haemoglobin decreased; Laboratory test abnormal; Prothrombin level increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0213633	12/05/2003	OH	47.0	47		F	12/05/2003	Started with sore throat and headaches.  Started diarehha on 12-4-03 and muscles aches, congestion.  Lower back is very tender.  Dizziness and fever of 101.3 degrees and a cough.									N	12/02/2003	12/03/2003	1		UNK	PVT	loperamide, estrace, atenolol, dicyclomine, prevacid, colestid and amitriptyline	None	none			1						1	Back pain; Cough; Diarrhoea; Dizziness; Headache; Myalgia; Nasal congestion; Pharyngolaryngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213635	12/05/2003	AL	30.0	30		F	12/05/2003	Shortly after the shot I had a big red lump on the area where the shot was administered. I then began feeling tired, my muscles hurt, I had ringing in my ears, I had what the doctor described as bells palsy, it seems as my symptoms just keep occuring in a circle. I suffered from anxiety attacks, lost weight, developed severe costochondritis. I finally got diagnosed with Fibromyalgia( autoimmune disorder)I was a healthy person before the shot now I'm always sick. I took the shot in 1997 and showed the localized red bump so the next year in Oct. 98 I told the doctor about the reaction the year prior and he said just go ahead and take it you'll be allright and since I worked at the hospital I had to take the flu shot. After that Oct. 98 date I've never been the same. I'm afraid to take the flu shot because I think I will have even a more violent reaction so I have not taken a flu shot since that day.				Y					N	10/15/1998			Developed Fibromyalgia shortly after the flu shot, health has never been the same since Oct. 98.	MIL	UNK		None, I was a very healthy person.				1						1	Anxiety; Facial palsy; Fatigue; Fibromyalgia; Injection site mass; Myalgia; Tinnitus; Weight decreased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0213636	12/05/2003	WA	1.1	1	.1	M	12/05/2003	13 mo old received vaccine with preservative.  No adverse reaction.  Mother notified.									Y	12/03/2003			none	UNK	UNK						1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~not available~1~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213637	12/06/2003	OH	31.0	31		F	12/06/2003	Within 15 minutes of the vaccine my legs were contorted and I was unable to move them.  Within 30 minutes from the waist down and with in 60 it was from the neck down.  I also had hives and petechiae.  It is three weeks later and I can move everything, but have MARKED weakness, am having hot flashes, bowel and bladder problems, and high blood glucose levels.  I am still in the hospital with no clear end in sight. Discharge summary states tremor, constipation. Medical records state urinary incontinence, dysarthria.				Y	Y	21			N	11/17/2003	11/17/2003	0	Medical records state hyperglycemia, increased SGOT, abnormal liver function, BUN increased.	MIL	PUB	Prozac, acetiline, Zocor, aspirin	n/a	Multiple sclerosis, had been in remission with no noticible gait disorder for several years. Medical records states allergy, labile emotional state, hyperlipidemia, abnormal; vision, drug dependent, depression.			1						1	Aspartate aminotransferase increased; Blood glucose increased; Blood urea increased; Constipation; Dysarthria; Gastrointestinal disorder; Hot flush; Hyperglycaemia; Hypokinesia; Liver function test abnormal; Muscular weakness; Paralysis; Petechiae; Tremor; Unevaluable event; Urinary incontinence; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0213638	12/06/2003	TX	8.0	8		M	12/06/2003	Patient not hungry and unable to keep down food. Throwing up (x 3) 5 - 9 hours after vaccine administered. No other symptoms. Provided with Benedryl.									U	12/06/2003	12/06/2003	0		PUB	UNK	Nasonex.		Common airborne/mold allergies. Moderate Peanut product allergy.			1						1	Anorexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213639	12/07/2003	TN	46.0	46		F	12/07/2003	15 mins after injection: tachycardic,hypertensive,full body tremors,teeth chattering,facial flushing,lightheadedness				Y					Y	10/18/2003	10/18/2003	0	all lab normal	UNK	UNK	celexa 20mg daily	none	none			1						1	Dizziness; Flushing; Hypertension; Tachycardia; Tremor	FLU3~EVANS VACCINES~765601~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0213608	12/08/2003	IA		30		M	12/06/2003	Individual reports pruritus at vaccination site for 2 weeks. Individual reports headaches not quite daily for 2 weeks. All symptoms now resolved.									Y	11/01/2003	11/15/2003	14	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Headache; Pruritus	ANTH~EMERGENT BIOSOLUTIONS~FAV078~4~SC~~ANTHRAX (BIOTHRAX)~1|FLU3~EVANS VACCINES~765412~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213609	12/08/2003	TX	20.0	20		F	12/05/2003	Patient complained of body aches and fatigue about 5 hours after innoculation.  No treatment indicated.									U	12/05/2003	12/05/2003	0	NONE	UNK	UNK	NONE	NONE	NONE			1						1	Fatigue; Pain	FLUN3~MEDIMMUNE VACCINES, INC.~500020P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0213610	12/08/2003	TX	32.0	32		F	12/05/2003	Complained of numbness to tongue, lips, face, complained of swelling to throat and difficulty breathing. FU: 30 minutes after vaccination she felt chest pain, her vital signs, monitored every 30 minutes, were okay. Oxymetry was normal. An ambulance was called, 0.3 cc epinephrine were administered but patients symptom continued to progress. Patient was sent to ER, from where she was released after 4-5 hours.				Y					Y	12/05/2003	12/05/2003	0	VSS; Pulse Ox 98%	PVT	OTH	NONE	NONE	Codeine Allergy			1						1	Dyspnoea; Hypoaesthesia; Tracheal oedema; Anaphylactic reaction; Chest pain; Dyspnoea; Hypoaesthesia; Throat tightness	FLUN3~MEDIMMUNE VACCINES, INC.~500020P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Emergency room visit	Influenza
0213611	12/08/2003	NC	44.0	43		F	12/05/2003	Chest pain/ shortness of breath/ anxiety				Y					U	12/05/2003	12/05/2003	0	EKG	PVT	PVT	NONE	NONE	NONE			1						1	Anxiety; Chest pain; Dyspnoea	FLU3~EVANS VACCINES~765957~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0213612	12/08/2003	NC	0.8	0	.7	F	12/03/2003	Rash on arms and legs.  Urticaria.				Y					Y	11/20/2003	11/21/2003	1	Visit to allergist revealed (+) egg allergy.	PVT	PUB	NONE	Upper respiratory infection	NONE		NC03137	1						1	Hypersensitivity; Rash; Urticaria	FLU3~SANOFI PASTEUR~U1088AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213613	12/08/2003	OH	44.0	44		F	12/05/2003	Less than 5 minutes, patient began to feel light-headed.  She stood up to find husband and blacked out/husband caught her.  Patient woke up with in seconds.  25mg Benadryl given per mouth with water.  Husband took her to ER per MD request.				Y					Y	12/05/2003	12/05/2003	0	NONE	PUB	OTH	Wellbutrin; Paxil; Terrazepam; Diflucan	NONE	NONE			1						1	Dizziness; Loss of consciousness	FLU3~SANOFI PASTEUR~U1088AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213614	12/08/2003	VA	32.0	32		F	12/05/2003	Patient related to writer incident of heavy epistaxis after flu shot last year-received vaccine 12/04/2003-now presents with multiple brusing arm (bilateral) and legs and denies other symptoms.									Y	12/04/2003	12/04/2003	0	CBC/Coags (PT/PTT) or dered	MIL	MIL	DepoProvera	NONE	NONE			1						1	Contusion; Epistaxis	FLU3~EVANS VACCINES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213615	12/08/2003	PA	58.0	58		F	12/02/2003	Patient returned back to office within 20-30 minutes states having a reaction to flu shot complained of shortness of breath and internal itching.  Patient took 2 Benadryl while in car before arriving back to office.  No apparent shortness of breath noted.  No further treatment required.  Observed for 45 minutes.				Y					Y	11/25/2003	11/25/2003	0	NONE	PVT	PVT	NONE	Hypertension; Chronic pain with Chest pain	L Horane; Bactrim; Erythemycin; Tetracyclin; Dalmane, Clondamyal; Celdacin; Duragesc; Percocet; Bactrim;			1						1	Dyspnoea; Pruritus	FLU3~SANOFI PASTEUR~U1098AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213616	12/08/2003	WI	54.0	54		F	12/05/2003	By 14:30 was in a somewhat euphoric state and was having wild thoughts.  Did not feel right.  By 19:00 had vomited, was woozy, had dyspnea, wheezing and was pale.  20:15 she was shaking with fast heart rate.  By 22:30 intense itching, no rash.  She laid down and meditated to help relax and symptoms finally subsided.  Took no meds.									Y	12/04/2003	12/04/2003	0	NONE	PUB	PVT	NONE	NONE	Penicillin, Cactus in southwest, 1983 heart attack, Emphysema			1						1	Dizziness; Dyspnoea; Euphoric mood; Heart rate increased; Pallor; Pruritus; Tremor; Vomiting; Wheezing	FLU3~EVANS VACCINES~765874~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213617	12/08/2003	TX	58.0	58		F	12/04/2003	Erythema, edema, increasing over 24 hours, initially no pain, increased discomfort and irritation, soreness for 30 hours. Resolved in 72 hours-96 hours slowly. Required Benadryl and topical steroids.									Y	11/06/2003	11/06/2003	0	NONE	OTH	PVT		NONE	NONE			1						1	Discomfort; Injection site erythema; Oedema; Pain; Skin irritation	FLU3~SANOFI PASTEUR~U108AAA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213618	12/08/2003	NY	84.0	84		F	11/22/2003	Faint body rash - erythema, extensive, near confluent macular-papular rash on all extremities including face.									Y	11/03/2003	11/21/2003	18		PVT	PVT	Vasotec, Imavil, ASA, Adcardia XL, NTG		CAD, HTN			1						1	Erythema; Rash; Rash maculo-papular	FLU3~SANOFI PASTEUR~U1143AA~1~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213619	12/08/2003	VA	34.0	34		F	12/02/2003	Loss of peripheral vision and tunnel vision with halo; Miller Fischer variant of Guillain-Barre. The medical record received on 12/10/03 state pharyngitis, dizzy and ataxia.									Y	10/30/2003	11/01/2003	2	NONE	PVT	PVT	Prinivil, Mircette	NONE	Hypertension, GERD, basilar artery migraine			1						1	Coordination abnormal; Dizziness; Guillain-Barre syndrome; Halo vision; Miller Fisher syndrome; Pharyngitis; Visual field defect	FLU3~SANOFI PASTEUR~U1268AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213620	12/08/2003	NC	88.0	88		F	12/02/2003	Stiff arm for 1 day. Given Tylenol every 4 hours for 24 hours. No problems with since.									Y	11/21/2003	11/22/2003	1	NONE	PUB	PUB	Senemet and Lanoxin	Parkinson's Disease	Parkinson's Disease			1						1	Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U1127AA~3~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0604N~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213621	12/08/2003	NC	31.0	31		F	12/02/2003	Follow up on 12/10/03: Pt given flu and pneumonia combination by mistake; advised by director to re-vaccinate with flualone. No adverse events.									Y	11/21/2003	11/24/2003	3	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Drug administration error	FLU3~SANOFI PASTEUR~U1127AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0604N~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213622	12/08/2003	AL	55.0	55		F	11/25/2003	Rash (red, fine, raised) on injection site arm, spreading rest of body. Pt took 2 PO doses of Benadryl that PM and AM for itching and burning. No relief obtained.									Y	10/29/2003	10/29/2003	0		PUB	PUB	UNK		None known		AL0328	1						1	Pruritus; Rash erythematous; Skin burning sensation	FLU3~EVANS VACCINES~765181~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213640	12/08/2003	CA	37.0	36		M	12/08/2003	Heart palpitations 3 days after vaccination, culminating in a diagnosed influenza vaccine myocarditis on Nov. 18.  Continue to suffer from random heart beat skips as of this writing. The medical records state sinus arrest, chills, headache, myalgia, chest pain, SOB, and dizziness.				Y	Y	1			Y	11/01/2003	11/04/2003	3	Increased white blood cell count	UNK	UNK	Claritin, Flonase	None	Hypercholesteremia, elevated triglycerides, viral syndrome, rhinitis allergic			1						1	Cardiac arrest; Chest pain; Chills; Dizziness; Dyspnoea; Extrasystoles; Headache; Myalgia; Myocarditis; Palpitations; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0213642	12/08/2003	IA	24.0	24		F	12/08/2003	Flu-like symptoms (101-degree fever, headache, chills, lethargy)									Y	12/04/2003	12/07/2003	3		PUB	PUB	ortho-tricyclen	none				1						1	Chills; Headache; Influenza like illness; Lethargy; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~unknown~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0213650	12/08/2003	TX	1.5	1	.6	F	12/08/2003	My daughter had welts and hives from head to toe, front and back.  Some difficulty breathing and a low grade fever and swollen eyes.  She was taken to the emergency room at 10pm and given vistarel and decadron IM.  She took the flu shot at about 10:00 am.  I picked her up from the daycare at 5pm and she was itching.  I noticed the welts at 6pm when I changed her diaper and placed some benadryl cream on her and gave her some tylenol.  Then at 10pm everything became worst.				Y					Y	11/25/2003	11/25/2003	0	None	PVT	UNK	N/A	N/A	Daughter has asthma.			1						1	Dyspnoea; Eye swelling; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0213652	12/08/2003	IL	55.0	54		F	12/08/2003	MORNING AFTER RECEIVNG VACCINE C/O SORENESS AND DISCOMFORT GOTTEN PROGRESSIVELY WORSE. ON 12/6/2003 CALLED PHARMASIST AND HE TOLD HER THEY SHOT THE NERVE AND TO TAKE TYLENOL.FEW HOURS LATER CALLED THE ER. AND THEY TOLD HER TO APPLY HEAT COMPRESS. NO RELEIF FROM HEAT COMPRESS.HASN'T SEEN DR. SHE SAID SHE CAN'T AFFORD IT. RECOMMENDED SHE CONTACT DR.									N	11/17/2003	11/18/2003	1	NONE	PUB	PVT	NONE	NONE	DEPRESSION			1						1	Discomfort; Pain	FLU3~EVANS VACCINES~765959~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213654	12/08/2003	MI	68.0	68		M	12/08/2003	Wife reports while on vacation patient experienced tingaling in hands and legs, returned home, follow-up with physician, progressive deterioration, hospitalized Oct. 31. Now in rehab. The discharge summary received on 1/28/04 states Guillain-Barre syndrome, urinary tract infection, urinary retention, hyperglycemia, gastritis, cholecystitis, back pain, and thrombophlebitis.			Y	Y	Y			Y	N	10/03/2003	10/18/2003	15	CSF abnormal	UNK	UNK		Denies	Degenerative disc disease, lumbar stenosis, hyperlipidemia, hypertension. UTI history at onset (GBS follow-up survey).			1						1	Back pain; CSF test abnormal; Cholecystitis; Gastritis; Guillain-Barre syndrome; Hyperglycaemia; Paraesthesia; Thrombophlebitis; Urinary retention; Urinary tract infection	FLU3~EVANS VACCINES~765415~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0213655	12/08/2003	MI	53.0	53		F	12/08/2003	Platelets dropped from 468 K/micro L to 10 K/microL. The discharge summary received on 2/9/04 states itching/ puritis rash, decreased appetite, weight loss, and purpura. The medical record received on 2/10/04 states abd tender, and fatigue.					Y	7			Y	11/05/2003	11/09/2003	4	Platelet count, decreased HgH, Guiac positive.	UNK	PVT	HCTZ 25 mg, prednisone 20 mg, impratropium br, atrovent, albuterol, advair	COPD, hypertension, hypopotassemia, and possible GI hemorrhage	none noted.  Patient stated -no history of reactions to flu vaccine.  Has had immunizations in previous years, epistaxis, anxiety.			1						1	Abdominal pain; Anaemia; Anorexia; Fatigue; Melaena; Platelet count decreased; Pruritus; Purpura; Rash; Weight decreased	FLU3~SANOFI PASTEUR~U1147AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0213656	12/08/2003	VT	52.0	52		F	12/08/2003	Burning/dysesthesia at vaccine site - same arm arthralgia and myalgias for two weeks									Y	11/21/2003	11/22/2003	1	none	PVT	PVT	Ritalin	none	none			1						1	Arthralgia; Injection site pain; Myalgia	FLU3~EVANS VACCINES~765855~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213659	12/08/2003	TX	23.0	23		F	12/08/2003	C/o low-grade fever, myalgias, headache, and localized swelling past the elbow of the RUE				Y					Y	12/02/2003	12/03/2003	1	N/A	UNK	MIL	amoxil, biaxin, demulen, aciphex, PNV, Oscal	N/A	N/A			1						1	Headache; Myalgia; Pyrexia; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0213660	12/08/2003	AZ	9.0	9		M	12/08/2003	Within 10-15 minutes after the vaccination and no complaints of illness, my son suddenly fainted and started to shake. He lost consciousnes for about 1 minute.  He looked pale white, ashey and lips were blue/gray.				Y					U	12/08/2003	12/08/2003	0		MIL	UNK	NONE	NONE	NONE			1						1	Cyanosis; Loss of consciousness; Pallor; Syncope; Tremor	FLU3~SANOFI PASTEUR~U1129AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213643	12/09/2003		84.0	84		M		A report was received from a health care professional on 11/19/03 concerning a male vaccinee more than 65 years old who experienced sniffles, cough, fever, sore throat, and was hospitalized and died 8 days after receiving Fluvirin on 11/9/03. On an unspecified date, 2 to 3 days after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. The vaccinee was treated with antibiotics on commencing on 11/13/03. The vaccinee was transferred to hospital on 11/15/03 and subsequently intubated. The vaccinee died on 11/17/03. The cause of death was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.  Follow up on 12/10/2003: Update 1, 11/26/03: A follow up report was received from a health care professional indicating that an 84 year old male vaccinee experienced respiratory failure 8 days after, with mild cough, vomiting, fever of 100 degrees F, occurring 4 days after receiving Fluvirin, and diarrhea occuring an unspecified length of time after vaccination.  The vaccinee has a history of respiratory distress, Alzheimer's disease, congestive heart failure, hypertension, alcohol abuse and dementia with psychosis since 12/31/1998.  The vaccinee also has a history of MI, arteriosclerotic heart disease, anxiety and insomnia from an unspecified date.  Concomitant medication taken included lorazepam, trazodone, quetiapine, atenolol, furosemide, and ranitidine hydrochloride.  On 11/13/03 the vaccinee experienced a mild cough with congestion, vomiting and a fever of 100 degrees F.  The vaccinee also experienced diarrhea on an unspecified date.  The vaccinee was treated with levofloxacin on 11/31/03.  At this point the vaccinee's respiration was rapid.  The vaccinee was admitted to hospital on 11/15/03 and on an unknown date was placed on a ventilator.  On 11/17/03 the vaccinee died due to respiratory failure.  A post mortem report is not available.  Update 2, 18February2004: A follow up report was received from a healthcare professional indicating that the vaccinee had received Fluvirin on 10 November 2003 and not on 9 November 2003 as previously reported. The vaccinee received Influenza vaccine (brand unspecified) previously on 25 November 2002. Additional concomitant medication included terazosin hydrochloride and lisinopril. The reporter indicated that the vaccinee had a history of respiratory distress, congestive heart failure, hypertension, myocardial infarction, moderate pulmonary hypertension and bi-ventricular failure prior to 31 December 1998. In addition to the events reported previously the reporter indicated that the vaccinee was also feeling week and lethargic on 13 November 2003. The reporter also indicated that the vaccinee died from respiratory collapse on 18 November 2003 and not on 17 November 2003 as previously reported. Update 3, 27 April 2004: A follow up report was received from a health care professional indicating that the vaccinee had received Fluvirin on 9 November 2003 as initially reported. The vaccinee had received a prior influenza vaccination on an unspecified date in November 2002. Additional concomitant medications reported included acetylonlicylic acid, valproic acid and levodopa in combination with carbidopa. The vaccinee also has a history of severe tricupsid regurgitation before 31 December 1998, and Parkinson's disease. The reporter indicated that the vaccinee was treated with levofloxacin and quoifenesin after 3 days with no improvement. The vaccinee was also treated with paracetonol for fever. The vaccinee's level of consciousness began to decrease and the vaccinee was experiencing shortness of breath. The vaccinee was treated with oxygen. The vaccinee was admitted to the hospital on 15 November 2003, where he was on a ventilator which was removed 2 days later. The vaccinee died on 18 November 1003. No follow up pending, all information received. Cross reference with: PJP-2003-01118, PJP-2003-01119, PJP-2003-01120, PJP-2003-01121, PJP-2003-01122, PJP-2003-01123, PJP-2003-01124, PJP-2003-01125, PJP-2003-01126, PJP-2003-01127, PJP-2003-01128, PJP-2003-01117.	Y	11/18/2003	Y		Y				N	11/09/2003	11/16/2003	7		UNK	UNK	Ativan, Trazodone, seroquel, atenolol, Lasix, Zantac, Hytrin, Zestril, Asavalproic acid, sinemet 10/100		Alzheimers disease; Congestive heart failure; Hypertension; History of ethanol abuse; MI; Dementia with psychosis; Insomnia; Arteriosclerotic heart disease; Anxiety; Respiratory distress (before 31Dec1998)		PJP200301129	1						1	Cough; Diarrhoea; Dyspnoea; Hypoxia; Nasal congestion; Pharyngolaryngeal pain; Pyrexia; Respiratory rate increased; Rhinorrhoea; Vomiting	FLU3~EVANS VACCINES~765855~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0213665	12/09/2003	MD	56.0	56		F	12/08/2003	Fever, chills, left arm pain, left leg pain.									Y	12/02/2003	12/02/2003	0	NONE	PVT	PVT	Norvasc, Advair, HCTZ, Singulair, Allerx, Premphase, Prempro	Asthma, HTN	Allergies: Erythromycin. Dx: asthma, HTN			1						1	Chills; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1130AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0869N~UNK~IM~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0213666	12/09/2003	MD	82.0	82		F	12/08/2003	Fever, redness left arm.									Y	12/03/2003	12/05/2003	2	NONE	PVT	PVT	Zyrtec, Quinine sulfate, Mevacor, Evista, HCTZ, Potassium, Xalatanghs, Singulair, Flor-dent, Combivent, Flonase NS	NONE	ASA, Avelox, codeine. Dx: Kyphosis, HTN, Asthma, Hyperlipidemia			1						1	Injection site erythema; Pyrexia	FLU3~SANOFI PASTEUR~U1260AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0869N~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213667	12/09/2003	MI	1.08	1	.1	M	12/05/2003	Mother reports very loose stools after both influenza #1 and #2 doses, resolved 4-5 days. No symptoms to suggest gastroenteritis.									Y	11/24/2003	11/24/2003	0	NONE	PVT	PVT	NONE	NONE	NONE	loose stools~Influenza (Seasonal) (Fluzone)~0~1.00~In Patient		1						1	Diarrhoea	FLU3~SANOFI PASTEUR~U1145AA~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213668	12/09/2003	WI	14.0	14		F	11/10/2003	Nausea began on 7th; 8th nausea, vomiting, fever 101-102 degrees all day; 9th fever broke about 3 PM. Red welt continued to grow in size from approx 3 to 4 1/2-6 1/2. Patient to MD on 11/10/03.				Y					Y	11/06/2003	11/07/2003	1		PUB	OTH		NONE	Diabetes			1						1	Erythema; Nausea; Oedema; Pyrexia; Urticaria; Vomiting	FLU3~SANOFI PASTEUR~U1094AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0213669	12/09/2003	CA	52.0	52		M	11/25/2003	Pt was given influenza vaccine. He denied any allergies to eggs, Thimerosol, or any other contraindications. 5 minutes after he returned to me, stated he wasn't feeling well. He lay down on the floor. Blood pressure was 90/60, HR 50. 911 was called. Epinephrine 0.3cc 1:1000 given SW into abdominal wall. Paramedics arrived and pt was monitoring sinus bradycardia. He was able to stand. He was transported to the hospital for observation.				Y					U	11/25/2003	11/25/2003	0		OTH	PVT	Serzone	NONE	UNK			1						1	Malaise; Sinus bradycardia	FLU3~SANOFI PASTEUR~U1075AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213670	12/09/2003	UT	50.0	50		F	12/08/2003	Fever, body aches, swelling, cough. [Much of Box 7 is too faint to read]									Y	12/01/2003	12/02/2003	1	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Cough; Oedema; Pain; Pyrexia	FLU3~EVANS VACCINES~760051~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213671	12/09/2003	CA				F		Soreness in deltoid muscle where injection was administered, up to 2 weeks following administration. Denies redness or swelling at site. No fever or other signs of infection or nerve problem. Recommended to see physician.									Y	11/12/2003	11/13/2003	1	NONE	OTH	PVT						1						1	Myalgia	FLU3~EVANS VACCINES~765979~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213672	12/09/2003	CA	62.0	62		M	11/26/2003	Achy, swelling in knees and fingers.									N	10/24/2003	11/24/2003	31		PUB	PUB	NONE					1						1	Joint swelling; Oedema peripheral; Pain	FLU3~EVANS VACCINES~765143~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213673	12/09/2003	NY	50.0	50		F	12/01/2003	Upper arm tenderness, extreme swelling from shoulder to elbow, bright redness of swollen area; swelling has reduced but needle site remains hard and swollen yet, about the size of a half dollar.									N	11/14/2003	11/15/2003	1		PUB	OTH	Premarin, Accupril					1						1	Erythema; Injection site induration; Injection site oedema; Oedema; Pain	FLU3~EVANS VACCINES~765954~7+~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0865N~2~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213674	12/09/2003	VA	8.0	8		M	11/28/2003	Returned to MD office 11/28/03. Left arm presenting large red circular area over flu shot injection site very itchy.									Y	11/26/2003	11/28/2003	2		PVT	OTH		NONE	NONE			1						1	Injection site erythema; Pruritus	FLU3~SANOFI PASTEUR~U1145AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213677	12/09/2003	IN	75.0	75		M	11/26/2003	Severe dermatitis. Broke out with red bumps from shoulder to elbow. Had itching, swelling and burning at site of injection and from shoulder to elbow of left arm. MD gave him salve that helped reducee itching, swelling and burning.				Y					Y	10/16/2003	10/17/2003	1	NONE	OTH	PUB	ASA tab only	NONE	Had same kind of reaction to a tetanus shot several years ago.	dermatitis~Tetanus Toxoid, adsorbed (no brand name)~~0.00~In Patient		1						1	Dermatitis; Injection site oedema; Pruritus; Skin burning sensation	FLUX~UNKNOWN MANUFACTURER~765668~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0213678	12/09/2003	IL	40.0	40		F	12/01/2003	Sore arm, shoulder and neck with limited arm movement.									U	10/24/2003	10/30/2003	6		OTH	PVT	NONE	UNK	NONE			1						1	Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~U1253AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213679	12/09/2003	IL	14.0	14		F	11/26/2003	Near syncopal episode after vaccine (about 5-10 seconds). Blood pressure normal. Responded to all questions and able to converse with MD. Pulse initially 60/minute up to 80/minute. T 97.9. Received epinephrine SC 0.3ml.									Y	11/26/2003	11/26/2003	0	NONE	PUB	PUB		Chest pain - chronic	Asthma			1						1	Heart rate increased; Pyrexia; Syncope	FLU3~SANOFI PASTEUR~U1091AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213681	12/09/2003	UT	47.0	47		M	11/17/2003	Itching all over; runny nose. Doctor gave me Prednisone 20mg.									Y	11/11/2003	11/11/2003	0		PUB	PVT						1						1	Pruritus; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213682	12/09/2003	RI	33.0	33		F	11/20/2003	Developed large, itchy raised hives in trunk, legs, arms approx 8-9 hours after receiving vaccine. Partially relieved by Benadryl 25 PO every 6 hours. Hives continue to persist and have exacerbated 48 hours after flu vaccine administration.				Y					N	11/17/2003	11/18/2003	1	NONE	PVT	PVT	UNK	NONE	Allergic to shellfish and ampicillin			1						1	Pruritus; Urticaria	FLU3~EVANS VACCINES~765486~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0213683	12/09/2003	AK	49.0	49		F	11/12/2003	2 days after immunization, pt experienced palpitations intermittently. Saw physician assistant 1 time, then MD again 11/8. Rx'd atenolol. P 100, BP 190+/100 when she checked during episodes. Peak of symptoms on 11/8, no episodes today.				Y					U	10/31/2003	11/02/2003	2	Had EKG and exam	PUB	PUB	NONE	NONE	NONE		AK200349	1						1	Palpitations	FLU3~SANOFI PASTEUR~U1141AA~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0521AA~5~~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0213684	12/09/2003	AK	1.0	1	.0	U		Mother states she recognized fever around 10:00 PM, gave Tylenol at this time. Child felt hot temp 102, proceeded to ER. Temp checked 2:00 AM at 104.				Y					Y	11/10/2003	11/10/2003	0		PUB	PUB			UNK		AK200348	1						1	Feeling hot; Pyrexia	FLU3~SANOFI PASTEUR~U1141AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0631M~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0017N~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0213685	12/09/2003	AK	43.0	43		M	11/04/2003	Nose was slight sniffles pre-vaccine, now running flood gate! Lungs tight. Used 3 doses of Albuterol which he hasn't had to use in a long time. Called back same day. Cold symptoms seen exacerbated although resp symptoms lowered and are improved.									Y	11/04/2003	11/04/2003	0	NONE	OTH	MIL	Imipramine/Motrin. Hydroxyzine/Vit E;Flonase	Slight cold	Dust, mold.		AK200346	1						1	Feeling cold; Pulmonary function test decreased; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1143AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213686	12/09/2003	AK	52.0	52		F	11/03/2003	Received call from pt 10/28/03 08:00: reports miserable night. Extreme pain in leg, hard to bear weight, nausea and emesis. Did report going home and gardening till early evening when felt increased pain. Took narcotic pain reliever which she uses for other health problems. Had emesis and increased pain through night and next 2 days off work.									Y	10/27/2003	10/27/2003	0	NONE	OTH	OTH	PPD-Mantoux-Aventis-C1616AA-left forearm intradermal	Rheumatoid inflammatory arthritis	TCN, Rheumatoid arthritis		AK200345	1						1	Nausea; Pain; Vomiting	FLU3~SANOFI PASTEUR~U1143AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1212M~1~IM~LL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213687	12/09/2003	AK	74.0	74		F	11/05/2003	Pt sent a note to PHN, dated 10/27/03, outlining swelling, redness and soreness across entire back of her arm to the elbow. By 4th day it had subsided to soreness and itching. By 6th day, still sore and less itching. Note sent.									Y	10/23/2003	10/23/2003	0		PUB	PUB			NKDA		AK200344	1						1	Erythema; Oedema; Pain; Pruritus	FLU3~SANOFI PASTEUR~U1141AA~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1212M~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213688	12/09/2003	AK	45.0	45		F	11/05/2003	Fever, shakes, dizziness, vomiting and headaches. Started 1 day after vaccinated.				Y					U	10/21/2003	10/22/2003	1		PUB	UNK					AK020343	1						1	Dizziness; Headache; Pyrexia; Tremor; Vomiting	FLU3~SANOFI PASTEUR~U1141AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1212M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0213689	12/09/2003	AK	83.0	83		F	11/03/2003	10/31/03: Received Flu and pneumo in afternoon and by that evening developed itchy rash on back, arms and stomach. Reports rash and itchiness have decreased but still present today 11/3/03. Reports she has not had any previous reactions to annual flu or pneumo given in 1997. Referred to PMD.									U	10/31/2003	10/31/2003	0		PUB	PUB	takes many meds	NONE	KNA		AK200342	1						1	Rash pruritic	FLU3~SANOFI PASTEUR~U1141AA~7+~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1212M~2~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213690	12/09/2003	AK	30.0	30		F	11/07/2003	Pt had a 4 1/2 cm wide x 5 cm long circle area of deep redness and warmth. No pain or itching. Fatigue symptoms for short duration.									Y	10/23/2003	10/24/2003	1	NONE	MIL	MIL		NONE	NKDA		AK200339	1						1	Erythema; Fatigue; Feeling hot	FLU3~SANOFI PASTEUR~U1270AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213691	12/09/2003	TN	74.0	74		M	11/20/2003	Pt called health dept c/o redness and soreness at injection site of pneumonia vaccine. Reports red and sore 10/28/03 but increased soreness reported on 10/29/03. Advised pt to contact PCP if symptoms worsened.									Y	10/27/2003	10/28/2003	1		PUB	OTH	NONE	NONE	NONE		TN03076	1						1	Injection site erythema; Pain	FLU3~EVANS VACCINES~765753~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0735M~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213692	12/09/2003	TN	65.0	65		F	11/19/2003	Vaccine received 4 PM 11/17/03; pt stated within 4-5 hours vaccination site red and swollen, hot to touch, c/o severe pain and discomfort in upper arm 11/18/03. Took Ibuprofen. 11/19/03 came to local HD, right arm and area of redness, swelling and warmth from antecubital area upward approx 3 inches in inner arm.									Y	11/17/2003	11/17/2003	0		PUB	OTH		NONE	Allergic penicillin, EES		TN03074	1						1	Discomfort; Injection site erythema; Injection site oedema; Injection site warmth; Pain	FLU3~EVANS VACCINES~765878~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0710M~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213694	12/09/2003		35.0	35		M	11/19/2003	A 35 year old male was seen on 11/16/2003.  Clinical information: Vaccine Related Adverse Event, specifically Anthrax.  Date of Onset: 11/13/2003.  Symptoms: Localized erythema and edema involving the SC tissue of left posterior arm. Labs: none.  Local Reaction: Injection site erythema, 1-5cm (dia) or mild tenderness within 24 hours.  Systemic Reaction: Global headache within 24 hours.				Y					Y	11/12/2003	11/13/2003	1	NONE	PUB	MIL	NONE	NONE	NONE			1						1	Headache; Injection site erythema; Injection site oedema; Injection site pain	ANTH~EMERGENT BIOSOLUTIONS~FAV076~6~SC~LA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~765756~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0213695	12/09/2003	WA	42.0	42		F	12/05/2003	Vaccine administered at 10:55.  Patient presented with symptoms at approximately 11:20.  Complained of throat closing, tightness, angioedema, difficulty speaking, itching all over. The medical records states anaphylaxis.				Y					U	12/03/2003	12/03/2003	0	UNK	OTH	PVT	Etrace	UNK	Asthma, allergy to iodine, sulfa.			1						1	Anaphylactic reaction; Angioneurotic oedema; Pruritus; Speech disorder; Throat tightness	FLU3~EVANS VACCINES~766043~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0213696	12/09/2003	MI		55		M	11/24/2003	Bells Palsy-6 hours after receiving (diagnosis MD).  Paralysis right side of face, right lip/right eye.  Affected speech - not clear.  Stays open (right eye) using gtts-ing over the counter.  History of Bells Palsy 25 years ago.  Telephone contact made 11/24/2003 by PHN: Patient first noticed the paralysis of the right side of his face in the morning of 11/21/2003.  He could not close his right eyelid and the right side of his mouth was paralyzed; his speech was not clear.  He used over the counter eye drops until he could talk to his opthalmologist.  He was seen at the hospital ER on 11/21/2003 and was diagnosed as Bells Palsy.  Patient stated that he had Bells Palsy approximately 25 years ago.  He has had flu shots every year without any problems.  12/01/2003: Follow-up telephone call made by the Clinic Supervisor.  Patient stated he was seeing slight improvement in his speech and had no obvious signs of paralysis in his face.  His eyelid continued to not close.  He had received prescription eye drops that were helping him.  Patient was given the supervisor's name and phone number for future contact as needed.  He was instructed to discuss receiving future flu shots with his private MD.				Y					N	11/20/2003	11/21/2003	1	CT Scan-rule out stroke; Done 11/21/2003	PUB	PUB	Humalin N/Humalog; Famvir 500mg TID	Insulin dependent diabetic	Pollen, Dust Allergies; Asthma; Diabetic		MI2003064	1						1	Facial palsy; Speech disorder	FLU3~EVANS VACCINES~765797~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0213699	12/09/2003	LA	46.0	46		M	11/24/2003	Rashes started 11/23/03 aching behind the eye.  Went to see PMD.  Not continuable Benadryl for reaction from flu shot, 3 tab day.									U	11/20/2003	11/22/2003	2		PUB	PUB	NONE	NONE	NONE		LA031201	1						1	Eye pain	FLU3~SANOFI PASTEUR~U1094AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213700	12/09/2003	MT	56.0	56		F	10/29/2003	Employee received flu vaccination (2nd in her life time) 10/28/2003 about 11:30.  By 5 or 6 pm that same day, employee noted redness and swelling at site of injection.									Y	10/28/2003	10/28/2003	0	NONE	PVT	PVT	Nexium	NONE	NONE			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1093AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213701	12/09/2003	MT	30.0	30		F		Received flu shot 10/28/2003.  Changed cloths 10/29/2003 and noted red hot area where flu shot had been given.									Y	10/28/2003	10/29/2003	1	NONE	PVT	PVT	Paxil; Loveral	NONE	NONE			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U1093AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213702	12/09/2003	MT	20.0	20		F	11/13/2003	Flu shot 10/27.  On 10/29 rash on back.  Took Benadryl cleared up went away.									Y	10/27/2003	10/29/2003	2	NONE	PVT	PVT	Birth Control Pills	Vomiting flu bug	NONE			1						1	Rash	FLU3~SANOFI PASTEUR~U1093AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213703	12/09/2003	MT	51.0	51		F	11/06/2003	Flu shot given, RN pulled back-no blood return in syringe.  After shot, immediate bruising and swelling.  No other side effects.									Y	11/05/2003	11/05/2003	0	NONE	PVT	PVT	Diavan; HCTZ	Sarcoid	Sarcoid			1						1	Contusion; Injection site oedema	FLU3~EVANS VACCINES~765876~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213704	12/09/2003	MA	3.0	3		M	12/05/2003	Pt received influenza vaccine on 11/12/2003.  On 11/24/2003, patient developed idiopathic thrombocytopenic purpura with a platelet count of 3,000.				Y					Y	11/12/2003	11/24/2003	12	Platelet count: 3,000	PVT	PVT	NONE	NONE	Patient had pneumonia on 10/27/2003.			1						1	Platelet count increased; Thrombocytopenic purpura	FLU3~SANOFI PASTEUR~41270AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213705	12/09/2003	LA	4.0	4		M	10/23/2003	Had DTAP on 10/22/2003.  Right arm redness in 24 hours as shown in picture.									Y	10/22/2003	10/22/2003	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Erythema	DTAP~SANOFI PASTEUR~U1007DA~5~~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1108AA~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W11562~4~~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0134N~2~~LL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA		Influenza
0213706	12/09/2003	TX	4.0	4		M	12/03/2003	Vomiting, temperature 102, drowsy for 3-4 days beginning 11/22/2003.  Seen 12/03/2003 for bronchitis and ruptured left tympanic membrane.									Y	11/21/2003	11/22/2003	1	NONE	OTH	PUB	NONE	NONE	NONE			1						1	Bronchitis; Otitis media; Pyrexia; Somnolence; Vomiting	DTAP~SANOFI PASTEUR~U1006CA~5~IM~~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~785A2~7+~IM~~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~W1156~5~SC~~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0275N~7+~SC~~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|PNC~PFIZER\WYETH~493474~1~IM~~PNEUMO (PREVNAR)~1	USA		Influenza
0213749	12/09/2003	WA	72.0	72		F		A report was received from a health care professional on 11/19/03 concerning a female vaccinee more than 65 year old who experienced sniffles, cough, fever, and sore throat requiring hospitalization up to 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. The results of a chest x-ray was taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Follow up on 03/22/04 states:  Update 1, 11/26/03: A follow up report was received from a healthcare professional indicating that a 71 year old female vaccinee experienced oxygen saturation of 84% on 2 litres of oxygen, oximeter reading of 89% congestion, wheezing, and fever which led to hospitalization and which was considered life threatening after receiving Fluvirin on 11/14/03.  The vaccinee has a history of bipolar depression, hypertension, congestive heart failure, nocturnal dyspnea, atrial tachycardia, and generalized weakness from 01/14/03 and breast cancer unspecified allergies anxiety from a date not specified. The vaccinee is a smoker consuming 2 to 3 packets per day for 50 to 60 years and is on nasal oxygen as required. Concomitant medications taken included tamoxife, foxofenadine hydrochloride, valproate semisodium, lorozepam, lansoprazole, hydrocodine bitartrate with acetaminophen, and forusmide. On 11/16/03 an oximeter read 89% on 2 litres of oxygen. On 11/17/03 the vaccinee experienced a temperature of 100.1 degrees Fahrenheit. The vaccinee experienced wheezing and congestion with an oxygen saturation of 84% on two litres of oxygen on an unspecified date. The vaccinee was hospitalized on 11/17/03 and treated with increased oxygen. The vaccinee was discharged on 11/21/03.  The outcome of the events was not reported. Update 2, 03/01/04: Further information received from a health care professional indicated that the vaccinee had an oxygen saturation of 89% at rest on 11/16/03 and a temperature of 99.6 degrees Fahrenheit increasing to 100.1 degrees Fahrenheit on 11/17/03.  The vaccinee's symptoms started approximately 48 hours following Influenza vaccination on 11/16/03.  The vaccinee was discharged from hospital on 12/18/03.  The vaccinee also has a history of renal failure, coronary artery disease, orthropnea and allergies to Augmentin, hepatin and sulfa. Further concomitant medications taken included digorin, diltioten hydrochloride, lovothyroxine sodium and iprotropium in combination with salbutamol. The vaccinee is also receiving oxygen 1-2L to maintain saturation greater than 90%.  Follow up pending. Update 1. 26 November 2003: A follow up report received from a health care professional indicating that a 71-year-old female vaccinee experienced oxygen saturation of 64 on 2 liters of oxygen, oximeter reading of 89 %, congestion wheezing and fever which led to hospitalisation and which was considered life threatening after recieving FLUVIRIN on 14 November 2003. The vaccinee has a history of bipolar depression, hypertension, congestive heart failure, nocturnal dysphea, atrial tachycardia, and generalise weakness from 14 January 2003 and breast cancer, unspecified allergist and anxiety from a date not specified. The vaccinee is a smoker consuming 2 to 3 packets per day for 50 to 60 years and is on nasal oxygen as required. Concomitant medications taken included tamoxifcn, fexofenadine hydrochloride, valproate semiaodium, lorazepam, lansoprazole, hydrocodone bitartrate with actaminophen, and chrotemide. On 16 November 2003 an oximeter read 89% on 2 liters of oxygen. On 17 November 2003 the vaccinee experienced 1 temperature of 100.1 degrees Fareneit. The vaccinee experienced wheezing and congestion with an oxygen saturation of 84% on two liters of oxygen on an unspecified date. The vaccinee was hospitalised on 17 November 2003 and treated with increased oxygen. The vaccinee was discharged on 21 November 2003. The outcome of the events was not reported. Cross reference with: PJP-2003-01129, PJP-2003-01118, PJ-2003-01119, PJP-2003-01120, PJP-2003-01121, PJP-2003-01122, PJP-2003-001123, PJP-2003-01124, PJP-2003-01125, PJ-2003-01127, PJP-2003-01128, PJP-2003-01117.			Y		Y				U	11/14/2003	11/16/2003	2	X-ray: Negative;	UNK	UNK	Toxoxifen, Allegra, Depakote, Ativan, Revacid, Vicodin, Lasix, Digoxin, Gardizem, Synteroid, Combivent, Oxygen, RUL, Prednisolone.		History of chronic obstructive pulmonary disease (before 14Jan03), on oxygen as required, smoker (2-3 packets per day for 50-60 years), Bipolar disorder (14Jan03-), Hypertension (before 14Jan03), congestive heart failure (before 14Jan03-), Nocturnal dyspnea (14Jan2003), Atrial tachycardia, Generalized weakness (14Jan2003), Breast cancer, Anxiety, Allergies to Heparin, Aumentin and sulfa, Renal failure, coronary Artery disease, orthopnea.		PJP200301126	1						1	Cough; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea; X-ray normal	FLU3~EVANS VACCINES~765855~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0213753	12/09/2003	MT	10.0	41		F	12/09/2003	Two weeks, four days after vaccine, very quick course of cold sweats, vomiting, extreme diarrhea, heachace and body aches.  Lasted for approx. 60 hours (2-1/2 days).  Same thing happened exactly two wks after last years vaccination 10/2002. Rest, drank clear fluids.									Y	10/22/2003	11/08/2003	17		UNK	UNK	Was give a PPD test at time of flu vac. (we do this for work purposes). Work at allergy & infectious disease facility.					1						1	Diarrhoea; Headache; Hyperhidrosis; Pain; Vomiting	FLUX~UNKNOWN MANUFACTURER~?~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213754	12/09/2003	MA	35.0	35		F	12/09/2003	approximately 1 hour after recieving flu vaccine hives appeared on trunk of body and spread to extremities over the course of next 5 hours.  Took antihistimine and used topical cream to relieve itching and swelling.  Swelling was reduced by next morning but hives returned when antihistimine wore off.				Y					Y	12/08/2003	12/08/2003	0	none	UNK	UNK		none	none			1						1	Pruritus; Swelling; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0213755	12/09/2003	SC	59.0	59		F	12/09/2003	12hrs after vaccination pt c/o reddness and warmth at vaccination site, @ 18hrs c/o swelling at site, @ 24hrs c/o temp 101, muscle aches, nasal congestion and cough.  Pt also c/o nodule developing at elbow.									U	12/05/2003	12/06/2003	1	None	MIL	MIL	None	None	None			1						1	Cough; Injection site erythema; Injection site swelling; Injection site warmth; Myalgia; Nasal congestion; Pyrexia; Skin nodule	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213756	12/09/2003	NV	3.0	37		M	12/09/2003	3 Days post vaccination had acute onset of vertigo( dizziness, nausea and vomitting) lasting 3 days. Equilibrium loss still occurring. Was told by Physicians and Specialists that I suffered from Viral Labrynthitis that may be related to Flu vaccine and could take months to years to fully resolve.				Y					N	10/08/2003	10/11/2003	3	Nystagmogram, MRI, Hearing test, CT scan	PVT	PUB						1						1	Dizziness; Labyrinthitis; Nausea; Vertigo; Vomiting	FLU3~SANOFI PASTEUR~U10998A~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213759	12/09/2003	RI	2.0	2	.5	M	12/09/2003	He was seen on 11/12 for symptoms of asthma for 2 days, possibly in the context of a mile URI without fever.  He was started on albuterol aerosols and was seen the next day.  He had improved and was given the influenza vaccine on 11/13.    On 12/8 (iover three weeks later) he developed facial urticaria.  This progressed to bilateral warmth, swelling, and erythema of both elbow areas with overlying wheals.  He had fever of >102 rectally.  No other symptoms were present and he hs limited contacts with other children.  A rapid strep assay was negative.    He was treated symptomatically with antipyretics and diphenhydramine.    He tolerates eggs without reaction. No medications were being given other than the albuterol three weeks previously, which had been stopped.									U	11/13/2003	12/08/2003	25	rapid strep assay- negative	PUB	PUB	albuterol	asthma	prematurity developmental delay			1						1	Asthma; Erythema; Feeling hot; Pyrexia; Swelling; Upper respiratory tract infection; Urticaria	FLU3~SANOFI PASTEUR~UO1111A~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213760	12/09/2003	TN	63.0	63		M	12/09/2003	Arms ,legs, and back area  developed  small maculopapular rash approximately 5-6 days after administration of vaccines. Patient went to his PCP and received a steroid shot and steroid ointment to which the rash responded pretty well, but has not completly cleared.									Y	11/24/2003	11/30/2003	6		UNK	UNK	hydrochlorothiazide 25mg doxycycline 100mg zoloft 100mg celebrex 200mg lotrel 5/20	none	prostate CA			1						1	Rash maculo-papular	FLU3~SANOFI PASTEUR~61254AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0287N~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213768	12/10/2003	WI	1.33	1	.3	F	12/09/2003	12/3/03 within few hours post injection became cranky. 12/4/03 blotchy rash around injection site. Still cranky. 12/5/03 rash gone. Still cranky. Appetite decreased. 12/6/03 am-still cranky. Not eating much. 12/6/03 put in her room by parents. Door closed. Few minutes later, family realized they hadn't heard her. Went in, found her under her bed, unresponsive, eyes rolled back, fists clenched. Some jerking of upper extremities. Respirations absent. Cyanotic, cold and clammy. AFter some rescue breathing by family. Started breathing on her own and crying. Stayed alert-to hospital by ambulance. Follow up on 01/12/04: Pt is a 15 month pt who was admitted last night because of a significant apneic event and possible associated seizure.  Pt is usually healthy.  She did get her influenza vaccine on 12/03.  Yesterday, 12/06, she was a little whinier than usual but had no fever.  Maybe wasn't eating quite as good as usual.  Apparently sometime in the evening she went into her bedroom and closed the door.  Things sounded too quiet so the parents checked on her and found her still partially under her crib.  She wasn't wedged.  When they pulled her out initially apparently she was limp but her upper arms were flexed and maybe there were a few twitches of her distal upper extremity.  This was bilateral.  Her head might have been turned to one side.  She was blue and was seemingly unresponsive.  Her grandfather was in the house and he came and gave her some artificial breaths.  They had called 911.  Sometime during that call then she did start crying.  Initially when she started coming to she seemed to be somewhat dazed but then seemed to be relatively appropriate for the circumstances thereafter and not clearly post-ictal.  She did not wet her diaper.  In the ER she was afebrile and had normal vital signs, and there was no focal findings of any concern on her exam.  Chest x-ray was obtained which was unremarkable.  Basic metabolic panel, magnesium level, and CBC were also obtained and were unremarkable.  They were going to get a urinalysis but she had some labial adhesions so that was not obtained at the time.  It was decided to admit her overnight for observation.  Because of the apneic episode, and IV was placed.  A bag and mask were put at her bedside ready in case it was needed.  She was put on a continous pulse oximeter.  Overnight she did well.  There were no further events or concerns or new concerns.  Basically healthy child with primary apneic event which may or may not have had with it seizure activity.  If not clear what is the cause of this.  The family wonders about the influenza vaccine, that it had occurred more than 72 hours prior to this, and she has no ongoing neurologic symptoms.  She was not tightly wedged under the bed.  The parents stated that there is no bar or any other structure where her head was right there were she could have hit her head.  She did not have coughing or choking subsequent to the apnea.  She had a normal chest x-ray and normal O2 sat, so there is nothing that suggests foreign body aspiration. The medical record received on 1/12/04 states apnea.			Y	Y	Y	1			Y	12/03/2003	12/06/2003	3	Routine hospital labs-negative; On my physical exam on the morning of 12/07 her weight was 9.68 in the ER before her IV was placed.  Her blood pressure in the ER was 73/55 and on admission to the floor was 129/92 supposedly.  We will repeat that and make sure it is now appropriate.  Her heart reate in the ER was 158, respiratory rate 28 with crying.  She was crying with the heart rate as well.  Her temp in the ER was 99.7 rectally and she has been afebrile throughout her stay here.  Her O2 sat in the ER was 100% and was similar here.  She is looking well but fussy because she wants to get up and run around and she is in parents arms right now.  Head, eyes, ears, nose and throat: Reveals perfectly translucent TMs.  No conjuctival injection.  No rhinorrhea.  Her throat is unremarkable and mouth moist.  Her neck was supple.  Her chest was absolutely clear.  There were no rhonchi.  She had no coughing.  Her voice was not hoarse.  She had no stridor.  Abdomen soft and nontender.  In the genital area she had minimal amount of residual labial agglutination which I disrupte during my exam.  That area looks within normal limits.  She has no rash. Apparently she did the day after her immunization for influenza as a blotchy red rash on her left thigh.  This is now gone.  She is moving all fours well and equally.  Basic metabolic panel from the ER shows a sodium of 139, potassium 4.1, chloride 105, CO2 23, glucose 94, BUN 17, creatinine 0.5, calcium 9.5, and magnesium 1.9.  CBC with dif. revealed a white count of 7.200 with 28% granulocytes, 58% lymphocytes, 11% monos, 3% eos and 1% basos.  Her hemoglobin was 13.1.  Platelet count 188,000.  Perihilar infiltrates.	PUB	PUB	NONE	NONE	NONE			1						1	Agitation; Apnoea; Cold sweat; Coma; Cyanosis; Decreased appetite; Dyskinesia; Eye movement disorder; Injection site rash; Irritability; Laboratory test abnormal; Lung disorder; Pyrexia	FLU3~SANOFI PASTEUR~U1113AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0213769	12/10/2003	PA	1.9	1	.8	M	12/09/2003	Wheezing followed by cardio respiratory arrest on ventilator, chest tubes recovering.			Y	Y	Y	9	Y		N	11/21/2003	11/23/2003	2		PVT	PVT	Albuterol, Pulmicort	Mild upper resp.	Asthma			1						1	Cardiac arrest; Respiratory arrest; Wheezing	FLU3~SANOFI PASTEUR~U1124AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0213771	12/10/2003	PA	35.0	34		F	11/14/2003	Patient vaccinated 10/17/03 11 AM. Patient presented to ER 11/02 with back pain; was sent home only to return to ER with more pain 11/4. Sent home again. Returned to ER with  numbness and tingling in legs on 11/6. Was admitted to hospital where developed paralysis and on 11/10 had to be intubated. The medical record received on 2/5/04 states tracheal bronchitis and dysphagia. GBS follow up survey states Guillain Barre Syndrome. Follow up 2/09/05: Patient states she is 100% recovered. She spent 3 months in the hospital. Has occassional numbness in hands and feet. Has consistent tingling in hands.			Y	Y	Y	90			Y	10/17/2003			Lab test abnormal	OTH	OTH					PA0329	1						1	Back pain; Bronchitis; Dysphagia; Guillain-Barre syndrome; Hypoaesthesia; Laboratory test abnormal; Paraesthesia; Paralysis	FLU3~EVANS VACCINES~765854~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0213772	12/10/2003	PA	47.0	47		F	12/09/2003	States had a local reaction to tetanus vaccine in 1994. Wanted to get another as update. Was advised in 1994 to get in half doses. On 11/20/2003 given 1/2 dose. One week later 11/28/03, right upper arm swollen and tender. Status and swelling from earlier in the week. Postponed next dose.									Y	11/20/2003	11/28/2003	8	NONE	PVT	PVT	Advair, Provental inhaler, Singulair	NONE	Asthma	cellulitis~Td Adsorbed (no brand name)~1~38.00~In Patient		1						1	Injection site oedema; Pain	FLU3~SANOFI PASTEUR~U1145AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0991AA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0213773	12/10/2003	CA	64.0	64		M	12/08/2003	Red, raised rash upper arms. Administered Benadryl 25 mg PO, talked to pt by phone at 4 PM: rash gone and no other symptoms reported.									Y	12/08/2003	12/08/2003	0		OTH	PVT	NONE	NONE	NONE			1						1	Rash erythematous	FLU3~SANOFI PASTEUR~U1101AA~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213774	12/10/2003	IA	46.0	46		F	12/08/2003	11/17/03 started with dry right eye and twitching of eye. Shortly after intermittent numbness of right side of face and external ear. On 12/3/03 facial and eye drooping and difficulty closing eye. Right sided neck pain. Headaches. 12/8/03 saw nurse, diagnosed with Bell's Palsy and started on Medrol dose pack 401G. Still in treatment				Y					N	11/03/2003	11/17/2003	14		PUB	UNK	Centrum vitamin, Paxil, vitamin E	NONE	Environmental allergies, prolapsed mitral valve		IA03015	1						1	Dry eye; Facial palsy; Headache; Hypoaesthesia; Muscle twitching; Neck pain	FLU3~EVANS VACCINES~765952~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0213775	12/10/2003	VA	6.0	6		M	12/09/2003	Fever 103-104. Swollen, painful arm.									Y	12/08/2003	12/08/2003	0		PVT	UNK		NONE	NONE			1						1	Oedema; Pain; Pyrexia; Injection site erythema; Pain; Pyrexia	FLU3~EVANS VACCINES~765665~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0213777	12/10/2003	NY	47.0	47		F	12/05/2003	Body aches, fever up to 102.  Extreme fatigue, upper respiratory symptoms.  Cough, congestion, sore throat still ongoing.  Two days of total laryngitis.  Difficulty breathing.  Swollen glands.  Also, local reaction on arm-pain, swelling and itching.									U	11/14/2003	11/15/2003	1	Still not feeling well	PUB	OTH	Ziac/HCTC 5-6 .25mg	NONE	NONE			1						1	Cough; Dyspnoea; Fatigue; Injection site oedema; Injection site pain; Laryngitis; Lymphadenopathy; Nasal congestion; Pain; Pharyngolaryngeal pain; Pruritus; Pyrexia; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~U1127AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213778	12/10/2003	TN	11.0	11		F	12/02/2003	Numbness and weakness at left arm.									U	11/28/2003	12/01/2003	3	NONE	PVT	PVT	NONE	NONE	Attention Deficit Disorder			1						1	Hypoaesthesia; Muscular weakness	FLU3~SANOFI PASTEUR~U1080AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213779	12/10/2003	NY	49.0	49		F	11/25/2003	Right deltoid-injection site with redness, warmth, circular area.  Local cellulitis-antibiotic given.				Y					Y	11/21/2003	11/22/2003	1	NONE	PVT	OTH	UNK	NONE	NONE			1						1	Cellulitis; Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U1130AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213780	12/10/2003	CA	1.8	1	.8	F	12/05/2003	Urticaria developed about 4 hours after vaccine.				Y					Y	12/04/2003	12/04/2003	0	NONE	PVT	PVT	Carnitor	NONE	Carnitive deficiency			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1170AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213781	12/10/2003	CA		18		M		Patient had a mild reaction dollar size redness.									Y	11/13/2003	11/13/2003	0	NONE	OTH	MIL	NONE	NONE	NONE			1						1	Injection site erythema	FLU3~EVANS VACCINES~~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213782	12/10/2003	CA				F		Swollen/red/itchy/slight fever.  Same reaction as last year.  Went away a week ago.									Y	10/20/2003	10/21/2003	1	NONE	MIL	MIL	NONE	NONE	NONE	~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Injection site erythema; Injection site oedema; Pruritus; Pyrexia; Vaccine positive rechallenge	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213783	12/10/2003	VT	40.0			F	12/05/2003	After injection about 8-12 hours, noted increased injection site soreness and fever.									U				NONE	PVT	PVT	Wellbutrin; Prednisone; Remeron; Neurontin; Trazodone;	NONE	History of allergy to Thimerosal.			1						1	Injection site pain; Pyrexia	FLU3~EVANS VACCINES~765873~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213784	12/10/2003	IN	54.0	54		M	11/28/2003	Hives above waistline.  Light amount, approximately 20 spots.  Completely cleared up by 11/19/2003.									Y	11/19/2003	11/22/2003	3	NONE	OTH	OTH	Effexor	NONE	Allergic to any form of Codeine.			1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213785	12/10/2003	NE	13.0	13		F	12/04/2003	12/03/2003 @ 11:53, presented to ER with throat swelling, neck pain for several hours; mild difficulty swelling, no dyspnea.  Rash-macular over cheeks, no hives.  Given per mouth Benadryl/Ibuprofen.  ? Reactions as 2 days later, but thought should be reported.				Y					Y	12/01/2003	12/03/2003	2	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Neck pain; Rash macular; Throat tightness	FLU3~SANOFI PASTEUR~U1131AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213786	12/10/2003	NM	4.0	4		M	12/04/2003	Swollen, red, indurated arm-told to use Tylenol per mouth and cold packs.									U	12/02/2003	12/03/2003	1	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site oedema	DTAP~SANOFI PASTEUR~C1383AA~4~IM~RA~DTAP (DAPTACEL)~1|FLU3~EVANS VACCINES~765980~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~W1002~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0213787	12/10/2003	AK	57.0	57		F	12/03/2003	Large, red, inflamed area on arm for 2 weeks, painful, itchy. Used Benadryl cream for itching.									Y	10/27/2003	10/27/2003	0	NONE	PUB	OTH		NONE	Diabetes, hypertension, hypothyroid			1						1	Injection site erythema; Injection site inflammation; Oedema peripheral; Pain; Pruritus	FLU3~SANOFI PASTEUR~U1271AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213788	12/10/2003	NY	44.0	44		M	11/10/2003	Site red, hot to touch.				Y					Y	11/08/2003	11/09/2003	1	NONE	PVT	PVT	NONE	NONE				1						1	Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U1127AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0530N~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0213789	12/10/2003	FL	56.0	56		F	12/03/2003	Itchiness all over body and hives. Awaken with severe symptoms as above at 12:05 AM 12/3/03. Took Benadryl 50mg, went to sleep. Woke in morning with mild symptoms until mid morning and started itching again. ER - Solumedrol IV, Benadryl 25mg, Tagament IV.				Y					Y	12/01/2003	12/02/2003	1		PVT	UNK		NONE	PCN			1						1	Pruritus; Urticaria	FLU3~EVANS VACCINES~765499~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0213790	12/10/2003	PR	47.0	47		M	11/24/2003	TB tine reaction, 15-20mm induration, red, irritated, warm to touch, and tender.				Y					Y	11/02/2003	11/22/2003	20		MIL	MIL	NONE	NONE	NKA			1						1	Feeling hot; Injection site erythema; Injection site induration; Pain; Skin irritation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0213791	12/10/2003	TX	4.0	4		M	12/04/2003	The child's right thigh is swollen and red and warm to touch. The area is the size of a lemon.									Y	12/03/2003	12/04/2003	1		PVT	PUB	q	NONE				1						1	Feeling hot; Injection site erythema; Injection site oedema	DTAP~SANOFI PASTEUR~U1006BA~5~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1091AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W1156~4~SC~RA~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0585N~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0213792	12/10/2003	PA	49.0	49		F	10/20/2003	Numbness and severe throbbing muscle pain from left shoulder to left fingertips. No redness, warmth or edema noted. Discomfort interfered with activities of daily living. Treated with rest, alternating Tylenol 650mg and Motrin 400mg. Pain started 9 AM 10/14/03 and continued until 10/16/03 9 AM. No residual effects noted.									Y	10/13/2003	10/14/2003	1		PUB	PUB	NONE	NONE	Bee stings		PA0328	1						1	Hypoaesthesia; Musculoskeletal discomfort; Myalgia	FLU3~SANOFI PASTEUR~U1088AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213793	12/10/2003	PA	14.0	14		M	11/03/2003	Reported 2-3 hours after injection. Pt c/o numbness to fingers, pain up to the forearm. Left leg feels funny. Veins in arm bulging. On 10/30/03 veins still bulging. Arm is numb.									U	10/29/2003	10/29/2003	0		PUB	PUB	NONE	Hx of asthma	Hx of asthma		PA0327	1						1	Feeling abnormal; Hypoaesthesia; Pain; Vasodilatation	FLU3~SANOFI PASTEUR~U1088AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213794	12/10/2003	PA	64.0	64		F	11/03/2003	Pt noted abdominal cramps 10/30/03 about 8 PM. All day 10/31/03 and 11/01/03 she experienced frequent abdominal cramping and a bloating feeling but denied symptoms of vomiting or diarrhea. Symptoms gone by 11/01/03 and pt did not seek any medical attention or treatment. Pt reported to State Health Center on 11/3/03.									Y	10/30/2003	10/31/2003	1	NONE	PUB	PUB	Tapozde, Fosamax	NONE felt healthy	Diagnosed hyperthyroid 09/03 - medication only		PA0326	1						1	Abdominal distension; Abdominal pain	FLU3~SANOFI PASTEUR~U1088AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213810	12/10/2003	MI	27.0			F		A report was received from a health care professional on 14 November 2003 concerning a 27 year old female vacinee who experienced closure of the throat, whcih was considered to be medically significant, 12 hours after receiving Fluvirin vaccine on 22 October 2003. On 22 October 2003, the vaccinee's throat closed 12 hours after receiving Fluvirin. The vaccinee wsa seen in an emergency room. The acute throat closure resolved, however, the vaccinee stated that she was still experiencing night time symptoms of throat closure which included wheezing and shortness of breath. At the time of vaccination, information regarding neomycin and polymycin allergies was not obtained. The vaccinee had not recovered at the time of the report. THere was insufficient information to determine the reporter's causality assessment. Update on 05 December 2003: follow-up information was received from the sponsor indicating that an error was made in the reporting assessment of this case during the QC by company pharmacovigilance. This case is to be reported. Follow-up pending.									U	10/22/2003	10/22/2003	0		UNK	UNK					200301083	1						1	Dyspnoea; Throat tightness; Wheezing	FLU3~EVANS VACCINES~765852~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213811	12/10/2003	MA	13.0	13		M	12/01/2003	This case was considered medically important (OMIC). Information regarding FluMist nasal solution was received from a pediatrician regarding a 13 year old male who developed pneumonia. Relevant medical history was not provided. Indication for FluMist was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. The pediatrician reported that the child had a fever on the same day as the FluMist administration. One hour post-immunization, his fever was 104 degrees F. Two days post-immunization, he was diagnosed with pneumonia. No additional information was available at the time of this report. Follow UP: The reporter considered this event medically important. Follow-up information received from the physician on 16-Dec-2003 provided patient identifiers, immunization date, onset date, test results and outcome. Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a pediatrician regarding a 13 year old male who develooped penumonia. At 13 years of age, the child received the first dose on 11-Nov-20003. The pediatrician reported that the child developed a fever 4 hours post -immunization. The fever ranged from 102 deg. F. to 104 deg F and persisted for 2 days. On 13-Nov-2003, the child was seen by the pediatrician and diagnosed with pneumonia. The child recovered. The pediatrician noted that she did not consider this event related to vaccine administratiion.									Y	11/11/2003	11/11/2003	0	Chest film 11/13/03 confirms penumonia.	PVT	OTH	UNK	Fever	UNK		HQWYE263825NOV03	1						1	Pneumonia; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0213813	12/10/2003	FL	71.0	72		F	12/10/2003	Left arm swelled from shoulder to elbow-very large, hot and tender. B/P increased to 207/104 and normal B/P around 125/76. Took 3 days for arm to return to normal. To ER on 10/11/03. Given Benadryl and prescribed Prednisone 20mg po QD  x6days and Keflex 500mg 1 tab po q 6h x 10days. Dx: Acute Allergic Reaction.				Y					Y	10/09/2003	10/11/2003	2	none	PUB	UNK	none	none	Allergies include allCaine drugs, Penicillin, Erythromycin, Halcion and Zocor. No illness or medical conditions disclosed.			1						1	Blood pressure increased; Hypersensitivity; Injection site warmth; Oedema peripheral; Tenderness	FLU3~SANOFI PASTEUR~U1137FA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0740N~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0213814	12/10/2003	WI	27.0	27		U	12/10/2003	Sore arm started within hours of vaccination.  Pain continued at the injection site and towards back of deltoid muscle rotating around upper arm, stopping approx 1 inch from underarm crease.    Pain is achy in nature and worse with motion that has now persisted for 3 weeks.  Pain is 2/5 on scale of 0/5.									N	11/20/2003	11/20/2003	0		UNK	PVT	None	None	None			1						1	Injection site pain; Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~U1264AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213815	12/10/2003	CA	39.0	39		M	12/10/2003	On Friday 12/5 small rash broke out on entire body after shower. Very ichy! saturday and sunday rash spread became larger and became more ichy. finally on sunday night after tring cortizon cream I became so ichy I went to clinic. Dr gave me IM shot of some type of steroid and another IM shot of some form of antihistamine. symptoms were gone by the time I got home. I was presribed Methylprednisolone 4MGUD and hydroxyzineHCL 25MG 1 every eigt hours for iching. the meds work but every morning after shower rash comes back and tkes most of the morning to subside.									N	12/01/2003	12/05/2003	4	N/A as far as I know	PVT	PVT						1						1	Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213817	12/10/2003	GA	62.0	62		F	12/10/2003	Flu vaccine given on 12/08/03 lt deltoid muscle, employee noticed redness, soreness, swelling at injection site on 12/09/03. Symptoms increased by am of 12/10/03, reported to employee health office today.Sent employee to convenient care office, MD instructed her to continue to watch area and report any increase in symptoms.				Y					Y	12/08/2003	12/09/2003	1		PUB	UNK	Claritin, prempro, multivitamin		allergies-restoril, clinitrol			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1102AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213818	12/10/2003	FL	79.0	79		F	12/10/2003	Patient received a flu shot, Fluzone 0.5 ml I.M. in the rt. deltoid at approximately 9:20 a.m. Friday, December 5, 2003. She denied any allergies, but had never had a flu shot before. After going to bed that night, she awakened approximately 1 a.m. Saturday morning because of pain in her arm. She noticed a small bruise at the injection site, but states there was no redness or swelling. She applied a cool compress and took an O.T.C. pain medication. She called the Health Dept. on Tuesday 12/9/2003 and was advised to call her physician. When I spoke with her today Wednesday 12/10/03 she stated she is still having difficulty and her physician stated there was little he could do for her. She would have to wait for it to resolve. She stated she was told to continue with her O.T.C. Meds and to apply warm moist compresses. She is following that advice.									U	12/05/2003	12/06/2003	1		UNK	PUB						1						1	Contusion; Pain	FLU3~SANOFI PASTEUR~U1147AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0564N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213819	12/10/2003	AR	55.0			F	12/10/2003	HAD LG LUMP IN BACK OF UPPER ARM,IT WENT AWAY AFTER 2 DAYS, PUT I WAS LEFT WITH SHOULDER JOINT PAIN AND A TENDER AREA TO THE TOUCH ON THE BACK UPPER AREA OF LEFT SHOULDER. IF I SLEEP WITH MY ARM UP WHEN I WAKE AND PUT MY ARM DOWN IT IS PAINFULL									N					UNK	UNK	TOPROL- EX,LIPITOR,MONOPRIL,METAGLIP, EFFEXOR,ASA		NIDDM DEPRESSION HTN			1						1	Injection site mass; Pain; Shoulder pain; Tenderness	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0213821	12/10/2003	FL	74.0	74		U	12/10/2003	I received the vaccine at 1:30 PM on 12-08-03. That evening approx. 9:30 PM I started to vomit profusely with diarhea also. That continued thru the nite. This is Wed. the 10th & I can't take food yet. Stomach, Ribs are very sore. I have no fever but am listless & tired out. Dr. told me to drink fluids so I won't dehydrate & tylenol.									Y	12/08/2003	12/08/2003	0		PUB	PUB	5m Plendil once dailey	None	None			1						1	Abdominal pain; Diarrhoea; Fatigue; Listless; Vomiting	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0213823	12/10/2003	NC	7.0	2	.6	F	12/10/2003	Fever, Chills Horseness				Y					U	12/08/2003	12/09/2003	1		PUB	UNK			Allergic to weeds, grass, cats, potatoes			1						1	Chills; Dysphonia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0211590	12/11/2003	OH	43.0	43		F	12/11/2003	Received flu vaccine at work on October 31, 2003 at approximately 1:00pm.  Developed anaphylactic reaction, respiratory arrest, seizures, and overall body rash.  Was placed on ventalator 50 minutes after receiving vaccine.  Hospitalized October31 through November 12, 2003.  Developed left sided weakness for which I am in physical therapy, and continue with occasional body rash and gastritis.			Y	Y	Y	13			U	10/31/2003	10/31/2003	0	contact hospital	PUB	UNK			hay fever			1						2	Anaphylactic reaction; Apnoea; Chest discomfort; Convulsion; Dyspnoea; Flushing; Gastritis; Loss of consciousness; Pruritus; Anaphylactic reaction; Convulsion; Gastritis; Hemiparesis; Rash; Respiratory arrest	FLU3~EVANS VACCINES~765877~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation	Influenza
0213831	12/11/2003	CA	47.0			M	12/05/2003	Information has been received from a physician concerning a 47 year old male who was vaccinated with a dose of pneumococcal 23v polysacchride vaccine. On the same day the pt was also vaccinated at a different site with a dose of influenza virus vaccine. Fourteen hours later the pt developed a fever of 103 to 104 deg, was lethargic, had breathing problems, chills, swelling of his arms and a 4cm area of erythema at the pneumococcal 23v polysaccharide vaccine injection site. He was admitted to the ER, and subsequently, was hospitalized and started on steroids and ceftriaxone. His white blood cell count was 16,000 and later rose to 22,000. The physician expressed concern about the particular lot of vaccine and inquired if there was a way to have the vaccine sent in to be looked at. Additional info has been requested. It was also reported that a male pt was vaccinated with a dose of pneumococcal 23v polyssaccharide vaccine and developed a swollen arm and redness from his shoulder to his wrist (WAES0312USA00217).  Follow up on 12/16/03: Information has been received from a physician concerning a 47 year old male who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 646159-0287N).  On the same day the pt was also vaccinated at a different site with a dose of influenza virus vaccine (manufacturer unknown).  Fourteen hours later the pt developed a fever of 103 to 104 degrees, was lethargic, had breathing problems, chills, swelling of his arms and a 4cm area of erythema at the pneumococcal 23v polysaccharide vaccine injection site.  He was admitted to the ER, and subsequently, was hospitalized and started on steroids and ceftriaxone.  His white blood cell count was 16,000 and later rose to 22,000.  The physician expressed concern about the particular lot of vaccine and inquired if there was a way to have the vaccine sent in to be looked at.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additonal information has been requested.  It was also reported that a male pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 646159-0287N) and developed a swollen arm and redness from his shoulder to his wrist (WAES 0312USA00217).				Y	Y				U				Body temp 103; WBC 16,000	OTH	OTH			UNK		WAES0312USA00043	1						1	Chills; Dyspnoea; Injection site erythema; Lethargy; Leukocytosis; Oedema peripheral; Pyrexia; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0287N~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0213835	12/11/2003	LA	40.0			F	12/04/2003	Information has been received from a 40 year old female who on 11/17/03 was vaccinated IM in the left arm with a dose of pneumococcal 23v polysaccharide vaccine. On 11/19/03, the patient presented to the emegency room with excruciating pain in her arm and swelling at the injection site. The patient noted that within 3 days, the site had swelled to 5 inches in diameter. The patient also noted swelling at the site of the lymph node and swelling over her entire body. She also indicated that she cannot raise her arm at the present time. The patient was admitted to the hospital on 11/19/03, and received a shot of morphine for pain. It did not relieve her pain. She also received x-rays at the site of vaccination, and blood work was done. The results were not reported. The patient was discharged from the hospital on 11/20/03. On 11/23/03, she returned to the emergency room. At that time, she was given prednisone, which did not help. At the time of the report, the patient was still taking the prednisone. She was not admitted to the hospital on this occasion. On 11/25/03, the swelling at the site was reported as 3 inches in diameter, and the patient reported that she was still having excruciating pain at the site. The outcome was reported as not recovered. Follow up information received on 12/1/03 from the patient indicated that she went back into the hospital on 11/25/03. She reported that she was admitted for excruciating pain at the site of injection, and that the swelling is still 3 inches in diameter at the vaccination site. The reporter considered the swelling at the site of injection, the excruciating pain in the arm, the inability to raise her arm, the swelling of the lymph nodes, and the swelling over the entire body to be immediately life-threatening. Additional information has been requested. It has been determined that WAES #0311USA02852 is a duplicate of WAES #0312USA00048. Therefore, WAES #0311USA02852 is being deleted from our files and the reports consolidated into WAES #0312USA00048			Y	Y	Y	1			N	11/17/2003	11/19/2003	2	X-ray injection site pending; Hematology pending	OTH	OTH	UNK		NONE		WAES0311USA02852	1						1	Injection site pain; Injection site swelling; Lymphadenopathy; Oedema; Pain; Abdominal pain; Alanine aminotransferase increased; Aspartate aminotransferase increased; Contusion; Hepatic steatosis; Hypokinesia; Infection; Injection site mass; Injection site oedema; Injection site pain; Laboratory test abnormal; Myopathy; Red blood cell sedimentation rate increased; White blood cell count increased	PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~unknown~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Life Threatening,Hospitalisation	Influenza
0213841	12/11/2003		53.0			F	10/17/2003	Pt received both Fluzone and Pneumovax. Had red, swollen arm; was feverish according to pt. Pt found in grand mal seizure around 2000. Pt found to be hypoxemic, wheezing, tachycardic, tachypnic in ER. Inj site was red and swollen.					Y				U	10/16/2003	10/16/2003	0	Depakote level: 36	UNK	UNK	Lamictal, Keppor, Deparkote, Imuran, Fosamax		Pt has long hx of sz. Pt has frequent petit mal sz but few grand mals.			1						1	Erythema; Grand mal convulsion; Hypoxia; Injection site erythema; Injection site oedema; Oedema peripheral; Pyrexia; Tachycardia; Tachypnoea; Wheezing	FLU3~SANOFI PASTEUR~U1266AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~119M~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0213843	12/11/2003	MN	63.0	63		M	12/01/2003	Patient received influenza vaccine (AP) 11/19.  Patient reported dizziness that started 3 days later and lasted greater than 1 week.									U	11/19/2003	11/22/2003	3	NONE-refused to be seen by provider	PVT	PVT	NONE	NONE	NONE			1						1	Dizziness	FLU3~SANOFI PASTEUR~U1128AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213844	12/11/2003		74.0	74		M	11/13/2003	This 74 year old male had a flu vaccine 7 days ago in his physicians office.  He was doing well until 3 days ago when he developed fever to 102 degrees, chills, nonproductive cough, myalgias, arthralgias.  He has also developed some painful swollen palms and soles of his feet with redness.  No vesicles, no sore throat or conjuctival discharge.  No known exposure.  He has been taking aspirin since yesterday for this.									U	11/06/2003	11/10/2003	4		UNK	UNK	Accupril		Hypertension; Mild Chronic Obstructive Pulmonary Disease; Pneumonia (1945); Remote Peptic Ulcer disease;			1						1	Arthralgia; Chills; Cough; Myalgia; Oedema peripheral; Pain; Pyrexia	FLU3~EVANS VACCINES~765795~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213845	12/11/2003		54.0			F	11/27/2003	I received a flu vaccination in my left shoulder and it caused severe aching and throbbing pain throughout my entire arm that lasted for over 3 weeks.									U	10/24/2003				UNK	UNK			I have been getting flu shots for several years and have never had any adverse reactions until now.			1						1	Pain	FLU3~SANOFI PASTEUR~U1270AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213846	12/11/2003	OK	59.0	58		F	12/09/2003	Knots, swelling, stiffness at ankles, knees and hands. Arthritis; prescribed Naproxen. Nurse follow up on 06/08/04 states: add, arthralgia.								Y	N	10/02/2003	10/17/2003	15		PVT	UNK			HBP; Cerebral blood clot; Allergy; Depression;			1						1	Arthralgia; Arthritis; Joint stiffness; Swelling	FLU3~SANOFI PASTEUR~O1255AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0256H~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0213847	12/11/2003	IA	81.0	81		M	12/01/2003	Flu vaccine administered 11/14.  Patient fell ill early on the 15th.  Had headache, sore throat, and achy muscles and weakness.  Was sickly 5 days.  Took Tylenol.									Y	11/14/2003	11/15/2003	1	NONE	PVT	OTH	NONE	NONE	NONE	flu~Influenza (Seasonal) (no brand name)~1~0.00~In Patient		1						1	Headache; Muscular weakness; Pain; Pharyngolaryngeal pain; Vaccine positive rechallenge	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213848	12/11/2003	CA	66.0	66		M	10/22/2003	Patient received flu vaccine 10/20/2003 on left deltoid.  Patient complained of itching Monday night and noticed a papule on 10/21/2003.  Complained of severe itching at site.									Y	10/20/2003	10/20/2003	0		MIL	MIL	NONE	NONE	NONE			1						1	Pruritus; Rash papular	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213850	12/11/2003	CA	76.0	76		F	12/01/2003	Had flu vaccine just before noon 11/19/2003.  Became extremely ill by evening.  Have been recovering for past 10 days-was very weak-upset stomach-could not eat solid food the first 4-5 days.  Chest phlegm and heavy cough.  To date, I am still coughing a little congested.  Only drank tea, honey and lemon; took only Tylenol.  Stayed at home and did not go to a doctor.  Note: Was not sick previously.									Y	11/19/2003	11/19/2003	0	Did not go to doctor.  Treated myself at home.  I am feeling much better today.	PUB	PUB	Cosoft 2 x day for glaucoma	NONE	Glaucoma			1						1	Cough; Decreased appetite; Malaise; Mucosal inflammation; Nasal congestion; Stomach discomfort	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213861	12/11/2003	FL	10.0	10		M	12/11/2003	LOCAL ERYTHEMA/INDURATION AT VACCINE SITE MEASURING 50mm BY 70mm. LOCAL TENDERNESS,PAIN. ONSET EVENING AFTER INJECTION RECEIVED 12/9/03 PRESENT STILL AM 12/11/03.									Y	12/09/2003	12/09/2003	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site pain	FLU3~SANOFI PASTEUR~U1141AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213862	12/11/2003	MS	80.0	80		F	12/04/2003	Received phone call from clients daughter.  She stated mothers right arm is red and swollen to the elbow.  warm to touch and painful to use it.  It look yellow under the skin where she was stuck.  She was advised to go to MD for evaluation.				Y					Y	12/02/2003	12/04/2003	2	none	PUB	PUB	Vitamin E, ASA, Topera, Altase	none	none		MS03099	1						1	Erythema; Feeling hot; Oedema peripheral; Pain; Skin discolouration	FLU3~SANOFI PASTEUR~U1271AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0685N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0213866	12/11/2003	VA	36.0	36		F	12/11/2003	About 2 hours after receiving the vaccination, I broke out in hives and had shortness of breath for several hours. I took a dose of Benadryl and used my Albuterol inhaler and the symptoms gradually subsided. I consulted the pharmacy where I received the vaccine and the pharmacist recommended taking the Benadryl and monitoring it carefully, which I did, using my peak flow meter. My peak flow remained at my average level. It did not seem serious enough to go to the ER. By about 10 PM, the symptoms were gone. I hope this was helpful!									Y	12/10/2003	12/10/2003	0		UNK	PVT	Singulair 10 mg./day Guaifenesin 2400 mg/day Pulmicort 2 puffs/day Albuterol inhaler/nebulizer solution as needed	None	Allergy to: EEC, Amoxicillin, Keflex, Ceclor, Cipro,  Bentyl, Codeine.	high fever, severe rash~Measles + Mumps + Rubella (MMR II)~~1.50~In Patient		1						1	Dyspnoea; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213867	12/11/2003	PA	27.0	27		F	12/11/2003	Since receiving the flu shot on November 7th, 2003, I have had consistent pain in my right arm.  The pain has subsided a little bit but I would have assumed that it would have gone away completely after a months time.  The pain mainly occurs when I move my arm and is limited to the upper part of my arm.									N	11/07/2003	11/08/2003	1		UNK	UNK		N/A	Pencillan			1						1	Psychomotor hyperactivity	FLUX~UNKNOWN MANUFACTURER~0~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213868	12/11/2003	MI	1.1	1	.1	F	12/11/2003	SHE DEVELOPED MILD CASE OF VARICELA AFTER 9 DAYS FROM RECIVIEING THE VARICELA VACCINE.									U	12/02/2003	12/10/2003	8		PUB	PUB	PHENERGAN DM SYRUP	URI				1						1	Drug ineffective; Rash vesicular	FLU3~SANOFI PASTEUR~~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0656N~4~IM~RL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0276N~UNK~IM~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0852N~UNK~IM~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0213869	12/11/2003	TN	5.0	5		M	12/11/2003	Three hours after having the shot he had a fever of 101.5, sweats, headache									Y	12/09/2003	12/09/2003	0		PVT	PVT		none	allergic to the Pertussis part of the DTP			1						1	Headache; Hyperhidrosis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213871	12/11/2003	MN	10.0	10		F	12/11/2003	The Flu shot was given at approx. 12:30p.m. on 12/10/03. Within just a few minutes she got very pale, dizzy, sweaty and felt clammy & nausea. She said she heard a buzzing sound in hear head. She heaved a few times, but nothing came up. The nurses there said it was probably from waiting in line for so long and it was warm and she needed to raise her blood sugar level. She fell asleep in the car on the way home, but when she awoke, had to throw up, which she did several times through out the evening, had a low grade fever until around 10:00a.m. 12/11.									U	12/10/2003	12/10/2003	0		UNK	UNK	none	none	none			1						1	Cold sweat; Dizziness; Hyperhidrosis; Nausea; Pallor; Pyrexia; Retching	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213873	12/11/2003	NC	4.0	51		F	12/04/2003	I NOTICED A LITTLE SWELLING IMMEDIATELY AFTER THE INJECTION. WE GAVE BENADRYL AND THE PATIENT WAS INSTRUCTED AFTER THE IMMUNIZATION OF SIDE EFFECTS AND WHAT THINGS TO WATCH FOR, AND WHAT  SHOULD BE REPORTED TO US.  PATIENT CALLED BACK 12-03-03 IN THE AFTERNOON AFTER RECEIVING HER SHOT AND STATED THAT SHE SAW A LITTLE REDNESS AND SWELLING AROUND THE INJECTION SITE. WE ADVISED HER ON MONITORING, THE SITE AND WHAT TO DO IF THINGS WORSENED. ALSO PROMISED TO FOLLOW UP WITH HER THE NEXT DAY.  CALLED ON 12-04-03 AND SPOKE WITH PATIENT AND SHE STATED EVERY THING HAD CLEARED UP AND SHE WAS FINE.									Y	12/03/2003	12/03/2003	0	N/A	UNK	UNK	ASTHMA MEDS	NO	NKA			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U1270AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213875	12/11/2003	CO	1.3	1	.3	F	12/11/2003	Fluvax and Prevnar - first dose of each for patient (my daughter).  Visit was for 15 month well-check.  Immunizations have been delayed so she has only received 2 doses HiB and 2 doses DTaP.  Within 10 minutes of receiving the vaccines, my daughter passed out; within 30 minutes she vomited twice; within 45 minutes she had vomited an additional 2 times.  Physician Assistant recommended we come back to the office to check her out.  Pulse-ox monitored and she was assessed to be okay.  Doctor stated that it was either a reaction to something in the vaccine, or a shock reaction.				Y					Y	12/04/2003	12/04/2003	0	Pulse-ox to determine respiratory compromise (1.25 hours after vaccine) results 93-97	PVT	PVT	None	None; well check indicated no illness prior to vaccination	None			1						1	Loss of consciousness; Shock; Vomiting	FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PNC~PFIZER\WYETH~unknown~1~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0213876	12/12/2003	CA	78.0	77		M		The subject is a 78 year old male who was admitted to the hospital due to respiratory failure, lower extremity weakness and died while enrolled in RSV11 study. The study received RSV vaccine or Placebo and influenza vaccine on 10/22/02. The subject developed lower extremity weakness with SOB 336 days post immunization and was admitted to the hospital on 9/23/03. He was found to have a large syrinx (syringomyelia) in the thoracic spinal cord probably secondary to chronic ischemia which had progressed to the point where there was compromise of his lower extremity innervation causing his weakness. Pneumonia was found on his chest x-ray which accounted for his respiratory failure; he was treated with antibiotics. He developed thrombocytopenia and leukopenia secondary to his immunosuppressive therapy and was treated with granulocyte colony-stimulation factor. His counts improved. He was maintained on hemodialysis. He developed further respiratory failure secondary to mucous plugging and required intubation for deep suctioning. He developed a subsequent left upper lobe infiltrate which was felt to be secondary to Aspergillus. Deep venous thrombosis was discovered and he was treated with Heparin. There was a long discussion undertaken with wife and the family requested comfort care only and to extubate the pt. Subject was extubated, given IV morphine for comfort and expired 15 days after admission on 10/8/03, 351 days post immunization. Discharge summary: 9/23/03-10/8/03. Admission diagnosis: respiratory failure, lower extremity weakness. Discharge diagnosis: Respiratory failure secondary to pneumonia exacerbating chronic obstructive pulmonary disease. Large thoracic spine syrinx probably ischemic in origin. neutropenia secondary to Cytoxan. ANCA positive vasculitis with secondary glomerulonephritis and end-stage renal disease, hemodialysis-dependent. Alveolar, ar hemorrhage syndrome secondary to ANCA positive vasculitis. Paroxysmal atrial fibrillation. Mucous plugging of the bronchial tubes with further respiratory failure. Deep venous thrombosis. Aspergillus pneumonia. The respiratory failure, large thoracic spine syrinx, neutropenia, ANCA positive vasculitis, alveolar hemorrhage, paroxysmal A. fib, mucous plugging on bronchial tubes, deep vein thrombosis, and Aspergillus pneumonia were reported by the investigator as not related to the study vaccine. The death certificate received on 1/2/04 states renal failure and vasculitis.	Y	10/08/2003			Y	15			N	10/22/2002	09/23/2003	336	Aspergillus infection; thrombocytopenia and leukopenia	UNK	UNK	RSV/Placebo; tRinalin; Seravent; Aeobid; Glucophage; Glucotrol; Lipitor; Digoxin; Zestril; Aldacton; Lasix;		Emphysema, asthma, CHF, HTN, COPD, chronic bronchitis; Endstate renal failure, Vaculitis;		200303297	1						1	Asthenia; Atrial fibrillation; Bacterial infection; Deep vein thrombosis; Infection; Leukopenia; Muscular weakness; Neutropenia; Pneumonia; Pulmonary haemorrhage; Renal failure; Respiratory failure; Thrombocytopenia; Vasculitis	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0213879	12/12/2003	MN	69.0	69		M		This subject is a 70 year old male who was admitted to the hospital due to right lung pneumonia while enrolled in the RSV11 study. The subject received his second injection of RSV vaccine or Placebo and Influenza vaccine on 10/29/03. Subject developed a temperature, shortness of breath, cough, wheeze, and cold symptoms 37 days post immunization and was admitted to the hospital on 12/5/03. Wife notified investigator that subject was taken to local MD on 5/12/03 with SOB, cold, cough, sputum and fever and was diagnosed with pneumonia by CXR. Treatment included Ibuprofen, Tylenol, Rocephin injection, Avalox and Tussionex. The temperature, SOB, coughing, wheezing, cold symptoms and diagnosis of right lung pneumonia was reported by the investigator as life threatening and possibly related to the study vaccine. Additional info received 12/15/03. The seriousness classification has been downgraded. The pneumonia as reported by the investigator did not meet the criteria for an SAE and should not have been reported.			Y		Y				N	10/29/2003	12/05/2003	37		UNK	UNK	Paxil; Tenormin; Advair Inhaler; Albuterol inhaler; Colchicine; ASA; Protonix; Alahan Eye drops; Xalatan Eye drops; Dyazide; RSV/Placebo		Asthma; Chronic bronchitis; HTN; Chronic ischemic heart disease		200303302	1						1	Cough; Dyspnoea; Pharyngitis; Pneumonia; Productive cough; Pyrexia; Rhinitis; Wheezing	FLU3~SANOFI PASTEUR~U1137HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0213880	12/12/2003					M	12/09/2003	This case was considered medically important (OMIC). Information regarding influenza virus vaccine was received from a healthcare professional regarding a male patient who experienced GBS. The patient received a dose on an unspecified date in 1985. The patient has a past history of poliomyelitis. Indication for influenza virus vaccine was immunization. Product was administered in on an unspecified date in 1985. Dose regimen was 1 dose. Concomitant medications were not reported. The patient was diagnosed with GBS after receiving a flu vaccine in 1985. The reporter stated that the patient does not have any continued problems associated with the event. This report of a serious, labeled event is being submitted in a 15 day time frame, as requested. No additional information was available at the date of this report.									U					OTH	OTH	UNK	UNK	Poliomyelitis		HQWYE437304DEC03	1						1	Guillain-Barre syndrome	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0213886	12/12/2003	VA	60.0	59		F	12/09/2003	Had overwhelming fatigue and fever to 101 and myalgias. Fever went to 102 and lasted until 10/14/03. Also had severe pruritis. Labs showed LFT's elevated, fever to 103.7 on 10/18. Admitted to hospital. Labs have all returned to normal presently.					Y	1			Y	10/06/2003	10/08/2003	2	ESR 86; GGT 600; LDH 616; CT scan abdomen negative; ALT 259; Alk phos 545; AST 97	MIL	MIL		Asthma; Fibromyalgia; Raynauds; Migraines; Psondylothiasis; GERD; Glaucoma; Anemia	Asthma; Fibromyalgia; Raynauds; Migraines; Psondylothiasis; GERD; Glaucoma; Anemia			1						1	Fatigue; Liver function test abnormal; Myalgia; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~U1098AA~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0213887	12/12/2003	WV	26.0	25		M	12/08/2003	Patient reportedly experienced seizures morning of 12/6/03 and admitted to ICU. Status unknown. The discharge summary received on 2/9/04 states respiratory failure, decreased level consciousness, alcohol intoxication, metabolic acidosis, hypokalemia, azotemia, and hypoglycemia.					Y				U	12/05/2003	12/06/2003	1	Linear atelectasis, decreased O2 sat, wbc elevated, acidotic  medical record states leukocytosis, hypoxia, sgpt increased. msv	OTH	MIL	Toprol; Zantac	NONE	NKA; Hypertension; Gastroesophageal reflux, alcohol abouse			1						1	Acidosis; Alanine aminotransferase increased; Alcohol poisoning; Apnoea; Blood urea increased; Convulsion; Hypoglycaemia; Hypoxia; Leukocytosis; Somnolence	ANTH~EMERGENT BIOSOLUTIONS~FAV081~UNK~SC~~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1014AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0213889	12/12/2003	TX	18.0	18		F	12/11/2003	Ten minutes after administration pt c/o nausea, feeling hot and faint. Assisted to bed to lie down. BP 100/60, P 60. Diaphoretic. Thirty minutes after administration of vaccine c/o abdominal cramping and had BM. BP 110/70, P 68. Fifty minutes after administration of FluMist feeling normal.									Y	12/10/2003	12/10/2003	0	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Abdominal pain; Dizziness; Feeling hot; Hyperhidrosis; Nausea	FLUN3~MEDIMMUNE VACCINES, INC.~500020P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0213891	12/12/2003	VA	1.83	1	.9	F	12/08/2003	Vaccine given left leg 1:15 PM. Call from mother 3:30 PM. Rash on face, trunk, back. Raised bumps. No fever, no itching. No Tx. Gone in 3 days.									Y	12/04/2003	12/04/2003	0	NONE	PUB	PUB		NONE	NONE			1						1	Rash erythematous	FLU3~SANOFI PASTEUR~U0176AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213892	12/12/2003	OH	4.0	4		F	12/04/2003	Large swelling of arm and shoulder, redness > 2 and fever. Seen at ER. Given antibiotic and diagnosed with cellulitis. Currently on Keflex at office follow up 12/4/03. To finish Abx and call office if worsens or not improved.				Y					U	12/02/2003	12/03/2003	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Cellulitis; Injection site erythema; Oedema peripheral; Pyrexia	FLU3~SANOFI PASTEUR~U1148CA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213893	12/12/2003	CA	9.0	9		F	12/11/2003	14 hours after shot was given, pt experienced diarrhea within the 1st hour at 3-5 minute intervals. Pt was healthy before the shot was given. Pt was home from school for 2 days. She did not have fever or feel achy. Just weak with diarrhea. Stayed home, ate Brat diet and recovered by evening 12/10/03.									Y	12/08/2003	12/09/2003	1		PVT	PVT		NONE	NONE			1						1	Asthenia; Diarrhoea	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213894	12/12/2003	MA	0.75	0	.8	F	12/02/2003	Temp 103.6 24 hours after vaccine. No irritabililty or lethargy. Pt appeared her usual self.									Y	11/11/2003	11/12/2003	1		PVT	PVT		NONE	NONE			1						1	Pyrexia	FLU3~EVANS VACCINES~765196~1~IM~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~MERCK & CO. INC.~0305N~3~IM~LL~HEP B (FOREIGN)~1	USA		Influenza
0213895	12/12/2003	ME	4.0	4		M		R arm deltoid - warm to tuch, red, raised.									U	12/09/2003	12/11/2003	2		PVT	UNK		NONE	NONE			1						1	Erythema; Feeling hot; Rash erythematous	DTAP~SANOFI PASTEUR~U1007DA~5~IM~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1131AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W1002~4~SC~RA~POLIO VIRUS, INACT. (POLIOVAX)~1	USA		Influenza
0213896	12/12/2003	MI	40.0	40		F	12/08/2003	Dizziness, palpittoin, pruritis, chest tightness.				Y					Y	11/21/2003	11/21/2003	0		PVT	UNK						1						1	Chest discomfort; Dizziness; Palpitations	FLU3~SANOFI PASTEUR~U1130AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213897	12/12/2003	WV	59.0	59		F	11/05/2003	Pt received flu and pneumonia vac 11/4/03 PM. On 11/5/03 AM pt noted redness. Reported to health dept. Pt seen by PA 11/5/03 PM for F/U evaluation. Antihistamine Rx given. Red area marked. Pt to return if redness increased. Redness did increase. Pt returned. They Rx Keflex and to continue antihistamine and return if no improvements. Pt stopped into health dept. Will call HD if further concerns.				Y					Y	11/04/2003	11/05/2003	1	NONE	PUB	PUB		None	None		WV0315	1						1	Erythema	FLU3~SANOFI PASTEUR~U1260AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1027M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0213898	12/12/2003	IL	21.0	41		F	12/09/2003	States arm felt sore, but has still continued to be sore 6 weeks later, is sore to pressure, can feel small hard area, has some pain with movement of that arm.									U	10/30/2003	10/31/2003	1		OTH	PUB	Asthma	NONE	Asthma			1						1	Injection site induration; Joint range of motion decreased; Pain	FLU3~EVANS VACCINES~765876~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213899	12/12/2003	NC	12.0	12		M	12/09/2003	Pt received flu vaccine at 0950 on 12/09/03 and was discharged from clinic. Prior to vaccine, mom stated that pt had no allergies. Pt returned to clinic at 1015 stating that he felt funny and was having trouble breathing. Pt brought to room. BP and pulse Ox monitored. IV fluids given. Pt discharged at 1200.									Y	12/09/2003	12/09/2003	0		PUB	UNK		NONE	NKDA, hypertension			1						1	Dyspnoea; Malaise	FLU3~SANOFI PASTEUR~U1088AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213900	12/12/2003	NC	57.0	57		F	10/15/2003	3cm oral red swollen area left bicipital area. Entire left arm in bicipital and deltoid area swollen and tender. No itching. Began 1 day after receiving vaccine. Instructed re: Motrin, Allegra and ice packs. F/U with MD in AM.				Y					Y	10/13/2003	10/14/2003	1	NONE	PUB	PVT	Zitia, LoPressor, HCTZ	NONE	High blood pressure, high cholesterol	~Tetanus Toxoid (no brand name)~~3.00~In Sibling		1						1	Erythema; Oedema peripheral; Pain	FLU3~EVANS VACCINES~765853~7+~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0541M~2~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0213901	12/12/2003	MN	7.0	7		F	12/05/2003	Hives on torso and extremities. Treated with Benadryl and the hives resolved. No recurrence of hives the following day.									Y	12/04/2003	12/04/2003	0	NONE	PVT	PVT	Multivitamin, fluoride	NONE				1						1	Urticaria	FLU3~SANOFI PASTEUR~U1170AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213902	12/12/2003		26.0	26		M	11/20/2003	Immunization 2 days ago now warm, slight pruritis, swelling, pain moderate left arm.									Y	11/18/2003	11/20/2003	2		MIL	MIL		NONE				1						1	Feeling hot; Oedema; Pain; Pruritus	FLU3~SANOFI PASTEUR~U1147AA~7+~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213903	12/12/2003	GA	69.0	69		F	12/07/2003	Sore throat, fever 103, chills, headache, body aches, dizzy, congestion. From 11/20 afternoon to 11/25/2003 complete bed rest, liquids, Advil.									Y	11/18/2003	11/20/2003	2		PUB	OTH		NONE	Asthma			1						1	Chills; Dizziness; Headache; Nasal congestion; Pain; Pharyngolaryngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0213904	12/12/2003	AZ	24.0	25		F	10/24/2003	c/o nausea without vomit and tightness in throat 2 hours post flu shot.				Y					Y	10/23/2003	10/23/2003	0		OTH	PVT			Codeine			1						1	Nausea; Throat tightness	FLU3~EVANS VACCINES~765797~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0213905	12/12/2003	KS	67.0	67		F	10/16/2003	Swelling in right upper arm, extending down to elbow. Extreme tenderness, some heat and swelling the size of an orange below injection site. Febrile, 100 degrees on 10/16/03. Pt to PCP. Rx: Clairin and Cephalexin 500mg every 6 hours for 10 days. Redness spreading, blotchy, redness on entry upper arm.				Y					Y	10/15/2003	10/15/2003	0		PUB	PVT	Arthritis and blood pressure meds	NONE	Arthritis, blood pressure			1						1	Erythema; Injection site warmth; Oedema peripheral; Pain; Pyrexia; Rash macular	FLU3~SANOFI PASTEUR~U1095AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0604N~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0213906	12/12/2003	CA	6.0	6		M	11/13/2003	Delirium, headaches, nausea and vomiting app. 26 hrs after vaccine given. Admitting diagnoses: episode of dissociation, seizure, low grade fever, possible reaction to the influenza vaccine. Discharge diagnoses: chronic seizure activity times five minutes at home, likely viral syndrome, possible influenza vaccine reaction. The pt is a previously well 6 year old male who received flu shot on 11/5/03. On the morning of 11/6/03 complained of a headache and stomachache. The pt was sent to home and sent back home from school an hour later. The pt vomited times three at home and in between very sleepy. The pt came downstairs in the afternoon and became acutely confused while sitting next to mom. He could not recognize his sister, his mom, or a glass of water. He simply said I don't know and shrug his shoulders while staring off. The pt then became limp and unresponsive and the mom laid him down and called 911. By the time the paramedics arrived, the child had jerking motions of his arms and body which mom estimates to have occurred for approximately five minutes. The paramedics told the mom that he was having a seizure. They brought him to ER for further evaluation and treatment. His temp at the time the paramedics arriving was 99.8 and there was confusion as to whether his temp in the child ER was 100.3 or 103. The pt remained unresponsive for the next hour to hours while at ER. CT scan of the head was done which was normal. WBC was 10.7, segs 93, no bands, 4 lymphocytes, 3 monocytes, hemoglobin 12.5, platelet count 315,000, electrolytes with sodium 134, potassium 4.1, chloride 100, bicarb 22, glucose 148, bun 13, creatinine 0.6, total protein 7.2, albumin 4, globulin 3.2, calcium 10, bilirubin 0.2, sgot 22, sgpt 34, alk phos 282, urinalysis is yellow, cloudy, specific gravity 1.020, ph 6.5, dipstick negative except for blood 1+ and 37 red cells, 0-2 white cells, urate crystals. This was a catheter specimen. Lumbar puncture was also done in the ER and spinal fluid showed 7 RBC's in the first tube, 2 in the fourth tube, glucose, 88, protein 25.6, gram stain was not reported and differential was not sent. Mom denies the possibility of the child having gotten into any medications or toxic substances. The pt denies having swallowed anything. The pt was observed overnight and by the time he came to medical center he was back to his normal state. He remained febrile through the night. There were no further episodes of vomiting. There are no episodes of diarrhea. The case was discussed with Dr. of neurology who was covering for doctor of pediatric neurology. We felt it appropriate to refer the child for evaluation. Also ordered a sleep deprived EEG in two weeks. We did not feel it necessary to start the child on antiepileptic medications at this time. There is no family history of seizures or febrile seizures. The child never had seizure activity in the past. The pt did receive a dose of Rocephin in the ER, but the antibiotics were not continued during his hospitalization. The pt also has a history of asthma which remained stable during his hospitalization. The follow up received on 12/24/03 states pt vomited x 3 at home later 1st confused, 2nd limp, and 3rd jerking. Unresponsive. Date of first clinic/ER/hospital visit for the reported seizure: 11/6/03. Diagnosis made by a neurologist. Seizure activity x 5 minute likely viral syndrome of poss flu vax reaction.				Y	Y	2			Y	11/05/2003	11/06/2003	1	CT scan of the head was done which was normal. WBC was 10.7, segs 93, no bands, 4 lymphocytes, 3 monocytes, hemoglobin 12.5, platelet count 315,000, electrolytes with sodium 134, potassium 4.1, chloride 100, bicarb 22, glucose 148, bun 13, creatinine 0.6, total protein 7.2, albumin 4, globulin 3.2, calcium 10, bilirubin 0.2, sgot 22, sgpt 34, alk phos 282, urinalysis is yellow, cloudy, specific gravity 1.020, ph 6.5, dipstick negative except for blood 1+ and 37 red cells, 0-2 white cells, urate crystals. This was a catheter specimen. Lumbar puncture was also done in the ER and spinal fluid showed 7 RBC's in the first tube, 2 in the fourth tube, glucose, 88, protein 25.6, gram stain was not reported and differential was not sent.	PVT	UNK		NONE	Possible asthma, allergic to PCN			1						1	Abdominal pain upper; Coma; Convulsion; Delirium; Disorientation; Dyskinesia; Headache; Hypotonia; Laboratory test abnormal; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1078AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0213907	12/12/2003	CA	69.0	69		F	11/11/2003	Swelling, erythema, pain at site of injection left arm, lasting 2 days.									Y	11/04/2003	11/05/2003	1	NONE	PVT	PVT	Aleve	NONE	COPD, asthma, osteoporosis,			1						1	Injection site erythema; Injection site oedema; Pain	FLU3~EVANS VACCINES~765876~3~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0863N~2~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213908	12/12/2003	MA	23.0	23		F	11/13/2003	Slight redness/puffiness at site. Cellulitis.									Y	10/27/2003	10/30/2003	3		PVT	PUB	NONE	NONE	NONE			1						1	Cellulitis; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1090AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~MASS. PUB HLTH BIOL LAB~Td100~UNK~IM~LA~TD ADSORBED (TDVAX)~1	USA		Influenza
0213909	12/12/2003	MA	92.0	92		F	11/17/2003	Pt was sitting and doing paper work, and she had no pain. About 4:15 PM she experienced severe pain in the right hip towards the lower back area. The pain was severe enough that walking was difficult. The pain lasted 2 hours, and there were no other symptoms.									Y	11/13/2003	11/13/2003	0	NONE	OTH	PUB	Synthroid, Coumadin, Lanaxin, bromide, Synthroid, Zantac, Isordil dinitrate, vitamins, stool softener	Very minor respiratory symptoms	Hypertension, hiatal hernia, arthritis			1						1	Difficulty in walking; Pain	FLU3~SANOFI PASTEUR~U1139AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213910	12/12/2003	MA	49.0	49		M	11/20/2003	Less than 12 hours after receiving vaccine. Sx: fever, chills, abdominal bloating, lethargy. Sx lasted 24 hours.									Y	11/14/2003	11/15/2003	1	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Abdominal distension; Chills; Lethargy; Pyrexia	FLU3~SANOFI PASTEUR~U1102AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213917	12/12/2003	CA	49.0	49		F	10/03/2003	Local systemic.  Swelling and pain at site of injection.  Fever, hypertension, tachycardia, anxiety.  Prescribed Dizadron, Benadryl				Y					Y	10/01/2003	10/01/2003	0	NONE	PVT	PVT	Nomovxne; Lescol; Voltron;	Degenerative Disk Disease w/Raniculcmilta	DSD; DDD; GERD; Hyperlipidemia;			1						1	Anxiety; Hypertension; Injection site oedema; Injection site pain; Pyrexia; Tachycardia	FLU3~EVANS VACCINES~765497~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~MASS. PUB HLTH BIOL LAB~td84~UNK~~RA~TD ADSORBED (TDVAX)~1|VARCEL~MERCK & CO. INC.~0594M~UNK~~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0213940	12/12/2003	MI	9.0	9		M	12/11/2003	Pt wanted to stand while he received 0.25 cc of Fluvirin IM to left arm, within 5 seconds of administering this, pt passed out. Eyes somewhat rolled back and body went limp. I laid him down and began calling out his name for a response. Within 5 seconds pt blinked his eyes and responded to me, alert and laughing. Pt laid down for at least 30 minutes and was checked by doctor then released, oriented without complaints. Some redness to injection site but cleared up within 10 minutes.									Y	12/08/2003	12/08/2003	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Eye movement disorder; Hypotonia; Injection site erythema; Loss of consciousness	FLU3~EVANS VACCINES~765703~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213987	12/12/2003	NY	27.0	27		F	12/12/2003	DEVELOPED FEVER AND CHILLS WITHIN 12 HOURS OF VACCINATION WITH INFLUENZA VACCINE 12/9/03 LASTING FOR ABOUT 12 HOURS. THIS WAS RELIEVED WITH IBUPROFEN 400MG PO Q4-6H X 4 DOSES. 12/11/03, RED RAISED AREA MEASURING 3INCHES X 5INCHES AROUND INJECTION SITE DEVELOPED WITH INCREASED PAIN IN ARM (INCLUDING AXILLA) WHERE VACCINE ADMINISTERED. HAD SAME REACTION AROUND INJECTION SITE WITH TETANUS VACCINE (LOT #U0991AA EXP.4/28/05)9/11/03 AT OFFICE.									Y	12/09/2003	12/10/2003	1	NONE	MIL	MIL				RED, RAISED AREA AROUND INJECTION SITE~Td Adsorbed (no brand name)~~27.60~In Patient		1						1	Chills; Pyrexia; Rash erythematous	FLU3~SANOFI PASTEUR~41097AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213988	12/12/2003	CA	25.0	25		F	12/12/2003	Severe rash (hives) developed 6 days after flu vaccination.  Started on knees and elbows, and spread to legs and feet.  Patient applied hydrocortisone cream on affected areas and took oral Benadryl every 4 hours.  Rash significantly reduced after 24 hours.									Y	12/05/2003	12/11/2003	6		PUB	PVT						1						1	Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~4.8~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213991	12/12/2003	PA	53.0	53		M	12/12/2003	rapid onset of symptoms, hands turned different colors, followed rapidly by chills.  went home, over next hours fever spiked high, headache, nausea.  night sweats, cramps, body ache			Y						U	12/12/2003	12/12/2003	0		PUB	PUB	Serzone		Depression			1						1	Chills; Headache; Muscle spasms; Nausea; Night sweats; Pain; Pyrexia; Skin discolouration	FLU3~EVANS VACCINES~765978~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening	Influenza
0213992	12/12/2003	MN	13.0	13		M	12/12/2003	migratory urticaria beginning day 4 from vaccine date									U	12/08/2003	12/11/2003	3		UNK	UNK	None	None	None			1						1	Urticaria	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0213993	12/12/2003	VA	39.0	39		F	12/12/2003	AWOKE MORNING AFTER VACCINATION WITH RIGHT EYE REDNESS AND RAISED, RED RASH EXTENDING FROM UNDER LEFT ARM ACROSS LEFT CHEST. (LEFT ARM VACCINATION).  DIAGNOSED AS SHINGLES IN ER LATE P.M. 12/10/03.  GIVEN VALACYLOVIR FIRST DOSE 12/11/03.  NO BLISTERING OR PAIN WITH RASH, OR SYMPTOMS PRIOR TO RASH ONSET, AND RASH HAS FADED CONSIDERABLY BY DAY 3 AFTER IMMUNIZATION WITH NO FURTHER SYMPTOMS.  EYE REDNESS DIAGNOSED IN ER SAME NIGHT AS CONJUNCTIVITIS.  EYE REDNESS RESOLVED WITHIN 24 HOURS WITHOUT TREATMENT.				Y					Y	12/09/2003	12/10/2003	1		MIL	UNK		COUGH AND COLD SYMPTOMS, MILD	NONE			1						1	Conjunctivitis; Ocular hyperaemia; Rash erythematous	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0213995	12/12/2003	GA	50.0	50		F	12/04/2003	c/o swelling in the right arm from elbow to wrist. No redness. no reaction at injection site.									Y	12/03/2003	12/03/2003	0		PUB	PUB	zocar mv					1						1	Oedema peripheral	FLU3~EVANS VACCINES~u1170aa~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213999	12/13/2003	NC	6.0	6		M	12/13/2003	Patient had received the nasal spray around 12pm.  He had decreased energy and fell asleep in the car that afternoon (doesn't usually do that).  He had decreased appetite and complained of stomach pains that evening around 8:30pm.  He starting vomiting around 11:45pm and vomited 4-5 times throughout the night.  I gave patient some phenergan liquid.  He also complained of a headache. Patient stopped vomiting and was able to hold down liquids the next morning.									Y	12/11/2003	12/11/2003	0		PVT	PVT	Singulair 5mg, Zyrtec 10mg & DDAVP 0.6mg all around 8:00pm on 12/10/2003	None	Environmental allergies			1						1	Abdominal pain; Decreased appetite; Fatigue; Headache; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~unknown~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0214000	12/13/2003	VA	71.0	71		F	12/13/2003	I was vaccinated by a nurse whose name I don't know on December 4, 2003.   My doctor was not informed.  I suffered adverse symptoms which included headache, slight fever and intestinal upsets for approximately 1 week.   The headache and fever lasted only 1 day, but the intestinal problems were daily, no diarreha, but a little vomiting and frequent bowel movements and a stomach ache every time I would eat.  A tiredness also accompanied these symptoms.  I took Motrin and Alleve and that helped somewhat.   I still have a bit of discomfort after eating in my stomach but that is gradually disappearing and I feel almost back to normal.									Y	12/04/2003	12/08/2003	4		UNK	PUB		None	None			1						1	Abdominal pain upper; Faecal incontinence; Fatigue; Gastrointestinal disorder; Headache; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~?~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0211238	12/15/2003	WV	23.0	23		M	12/15/2003	This is the 6 week follow-up information on this patient who developed myopericarditis following receipt of smallpox, typhoid, and influenza vaccinations.  The initial VAERS was filed 10/28/2003. Patient received his six week follow-up on 12/05/03.  He reports an improvement in symptoms, but he continues to experience occasional episodes of chest pain, dyspnea on exertion, and fatigue.  See symptoms below: Dyspnea:   He continues to experience daily dyspnea on exertion.  He has noticed some improvement in dyspnea since his discharge from the hospital. Chest Pain:  He reports episodes of chest pain that occur approximately once every 3 days.  He notices the chest pain after rapid position changes, such as standing up too fast.  He describes it as a sharp, non-radiating pain on his left side that lasts approx. 3 seconds.  He also experienced similar chest pain during the treadmill stress test that was relieved with rest.  In addition, he has noted that with deep inspiration, he experiences chest pain that lasts a few seconds.  If he holds his breath, the pain lasts longer. Headache:  Occasional headaches that occur approx. twice a week, but service member reports that this is baseline for him.  He reports a severe headache this past week.  Occasionally, he experiences blurred vision and nausea with the headaches.   Fatigue:  Continues to experience fatigue.  Wakes up feeling rested but by mid-day, he requires a nap.  He reports feeling tired throughout the afternoon and has to go to bed by 2000.  He remains on Convalescent Leave.  He is not currently on any medications.			Y	Y	Y	4			N	10/10/2003	10/18/2003	8	CKMB 3  Troponin I <0.03  CPK 244 H (35-232)  ECG Normal sinus rhythm.  Echo 12/5/03:  Ejection fraction 55%, Tricuspid valve, pulmonary valve, and aortic valve: Normal.  Mitral valve: Trace MR,LV,AO,RV,RA: Normal. Pericardium: No intracardiac mass or shunt by color Doppler.  Stress Test 12/5/03: Exercise Cardiolite Stress Test: Impression: Normal myocardial perfusion study. ECG: No ischemia or infarction. Clinical: Mild Chest discomfort with exercise. Functional capacity: Mildy decreased for age. Duke score: +4.5. Nuclear: No ischemia or infarction.  Ejection fraction of 59% and no wall motion abnormalities.	MIL	MIL	None	None	o History of frequent heat injuries (no hospitalizations for the heat injury) o Frequent Nosebleeds o HTN-Previously on medication but no HTN meds recently. o Chronic knee and back pain o Past history of chest pain			1						2	Chest pain; Cough; Dyspnoea; Headache; Laboratory test abnormal; Myocarditis; Pleural effusion; Pleurisy; Tinnitus; Chest pain; Dyspnoea; Fatigue; Headache; Laboratory test abnormal; Nausea; Pericarditis; Vision blurred	FLU3~PFIZER\WYETH~~1~IM~UN~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|SMALL~PFIZER\WYETH~~1~ID~LA~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~W0909~1~IM~UN~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|SMALL~PFIZER\WYETH~~1~ID~LA~SMALLPOX (DRYVAX)~2|TYP~UNKNOWN MANUFACTURER~W0909~1~IM~UN~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation	Influenza
0213944	12/15/2003	CO	72.0	72		M		This subject is a 72 year old male who was admitted to the hospital due to Pneumococcal Pneumonia while enrolled in RSV11 study. The vaccination received prior to the event was Influenza vaccine lot # U1137HA on 10/17/03. The subject also received RSV vaccine or Placebo and Influenza vaccine on 11/1/02. The subject developed shortness of breath, fever and cough 38 days post immunization and was admitted to the hospital on the same day, 11/24/03. Diagnosis of Pneumococcal Pneumonia. Chest x-ray showed left lower lobe pneumonia. Subject was started on Rocephin, Zithromax with good response. Subject is also on bi-pap. The subject's outcome is ongoing. The Pneumonia was reported by the investigator as possibly related to the study vaccine. Additional info received 12/11/03. Subject was intubated and on the ventilator 11/26/03 thru 3/12/03. He was diagnosed with a pulmonary embolism at that time. He was started on a heparin drip that continues at this time and also started on Coumadin. A sputum culture was obtained 9/12/03 with pending results. Subject will be transferred to rehab before he is discharged home. Diagnosis: Pneumococcal pneumonia, pulmonary embolism. The Pneumococcal pneumonia and pulmonary embolism was assessed by the investigator as possibly related to the study vaccine. Additional info received 12/12/03. Complimentary Information Form: confirmed that the SAE is possibly related to RSV vaccine. Confirmed that the SAE is not related to the Influenza vaccine. Last administration date before the SAE for RSV vaccine is 17/10/2003. Follow up SAE form provided. Additional information received Jan 7, 2004. Medical records: The pt was admitted to the medicine service for severe chronic obstructive pulmonary disease exacerbation. He was mechanically intubated for oxygenation and ventilation purposes. He did well on the ventilator, however, due to his severe chronic obstructive pulmonary disease, weaning him from the ventilator was quite difficult. he was extubated to face mask oxygen where he did well. The pt was placed on bilevel at night which significantly help his oxygenation-ventilation status and likely help by contributing to relief of his severe pulmonary hypertension. He was maintained on Flovent, Combivent, and Serevent, and continued to use these as nebulizers. His oxygenation levels were stable and he was eventually weaned down to approximately 2 L of oxygen by nasa cannula. The pt did have group A streptococcus bacteremia for which was treated with Zosyn. His cultures did eventually clear and he remained afebrile and stable off of the antibiotic. The pt did have a deep venous thrombosis diagnosed by an ultrasound in 11/26 in the left common femoral vein. The pt therefore required long ter anticoagulation and started on Heparin and then eventually Warfarin. There were also some questions whether he did have apulmonary embolism, however, the CT dated 11/26 did not show any evidence for pulmonary embolism. The pt was severely deconditioned after being taken off the ventilator and required significant pulmonary and physical rehabilitation. Procedures: 1. Intubation 2. CT scan of chest, abdomen, and pelvis. 3. Ultrasound, left lower extremity. 4. Transthoracic echocardiogram with an ejection fraction approximately 40% with increased right ventricular volume and moderate pulmonary hypertension with PA systolic of 40 to 50 mmHg. Discharge medications: Combivent, Lovenox, Warfarin, Flovent, Aspirin, Pepcid, Serevent. Subject recovered and was discharged from the hospital into a rehabilitation center 17 days later on Dec 11,2003. Additional information received on Mar 2, 2004 Subject was admitted to the ICU with severe SOB, fever. Chest X-ray showed a right lower lobe infiltrate, most likely representing inflammatory process/pneumonia. He was on the ventilator from 26/11/03 to 02/12/03. Sputum culture grew Beta Hemolytic Strep Group A. Blood Cultures grew Alpha Strep, not pneumococcus and staph. Hominis both contaminates according to PI. Arterial Duplex performed on 11/26/2003 showed left lower extremity deep venous thrombosis of the common femoral vein. Chest CT Scan on 11/26/2001 confirmed areas of atelectasis in the right middle lobe, and nasal segments of the left lower lobes bilaterally. There is also focus on density in the anterior segment of the right upper lobe. There is no pleural or pericardial effusion or pulmonary embolis. Treatment included Azithromycin, Ceftriaxone, Penicillin G, Eosyn, Heparin IV and Solumedrol. Subject recovered and will continue in the study. The Group A Beta Strep pneumonia and deep vein thrombosis was reported by the Investigator as possibly related to the study vaccine. Additional documents available with source file.  Medical records: Admission date 11/24/03-Discharge date 12/11/2003, Chest CT W NON IONIC (11/26/2003) Arterial duplex Le Bilat 11/26/03, Progress report, Laboratory results: 11/24/2003-12/09/2003, Chest single view VW port (11/25/2003) Chest PA/Lateral (12/9/2003)					Y	17			Y	10/17/2003	11/24/2003	38	9/12/03 Sputum culture obtained-results pending 11/26/03 Sputum culture grew Beta Hemolytic Strep Group A	UNK	UNK	Serovent; Albuterol; Flovent; Atrovent; Aleve; Pseudoephedrine; Predforte; Depotesterone; RSV/Placebo		COPD; Arthritis; Glaucoma		200303236	1						1	Bacterial infection; Cough; Deep vein thrombosis; Dyspnoea; Hypoxia; Lobar pneumonia; Pyrexia	FLU3~SANOFI PASTEUR~U1137HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0213947	12/15/2003	WI	41.0	40		F	12/09/2003	Patient received flu vaccine 10/22/03. Developed. Sensory symptoms of numbness tightness & soreness in legs as of 2-10-04.   Nurse follow up on 07/27/04 states: pain, blurred vision, burning of skin, dizzy, nausea, difficulty walking, urinary retention, tremor, fever.				Y	Y	4			N	10/22/2003	10/29/2003	7	MRI of C-spine - transverse cervical myelitis. CSF abnormal, cervical disc bulging	PVT	PVT			arthritis			1						1	Amblyopia; Arthropathy; CSF test abnormal; Dizziness; Gait disturbance; Myelitis transverse; Pain; Pyrexia; Tremor; Unevaluable event; Urinary retention	FLU3~EVANS VACCINES~765501~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0213948	12/15/2003	TX	21.0			F	12/09/2003	C/o fatigue 5 minutes after receiving vaccine (FluMist) and cloudy mentation. After 20 minutes observation Sx resolved. Vital signs stable throughout. Received FluMist 10:00 AM, c/o feeling fatigued after receiving FluMist. No numbness of tongue or lips, no CP, no SOB, no HA.				Y					Y	12/09/2003	12/09/2003	0	Vital signs stable	PVT	UNK		NONE	NONE			1						1	Fatigue; Mental impairment	FLUN3~MEDIMMUNE VACCINES, INC.~500020P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0213950	12/15/2003	TX	6.0	6		F	11/26/2003	Rash occurred 1 day after vaccines were administered on both arms. Urticaria present. Pt took OTC Benadryl.									Y	11/04/2003	11/05/2003	1		PUB	PUB		NONE			TX03146	1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~U1092AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W1002~4~~RA~POLIO VIRUS, INACT. (POLIOVAX)~1	USA		Influenza
0213951	12/15/2003	TX	6.0	6		M	11/24/2003	Pt administered flu vaccine and 4 hours later developed hives/urticaria on back, chest, all 4 limbs.									Y	11/20/2003	11/20/2003	0	Pt never ate eggs in any amount.	PVT	PVT	NONE	NONE				1						1	Urticaria	FLU3~SANOFI PASTEUR~U1144AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213952	12/15/2003	TX	34.0	34		F	11/18/2003	3:30 2 hours after injection, client reports feeling funny, extremely nauseated, light headed and foggy. BP 174/104, irregular pulse. 3:40 BP 156/90, irregular pulse, nausea and light headedness present, but less. 3:50 BP 148/90, irregular pulse, transported by friend to Dr. Client reports BP 174/104 in physician's office, given Veralan and observed for 30-40 minutes.				Y					Y	11/13/2003	11/13/2003	0		OTH	PUB		NONE	Allergic: Codeine. Previously diagnosed with hypertension, after weight loss medication. P/C client has not been on meds for 1 1/2 years. BP WNL 2 weeks prior to vaccine.		TX03144	1						1	Disturbance in attention; Dizziness; Feeling abnormal; Heart rate irregular; Nausea	FLU3~SANOFI PASTEUR~U1255AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213953	12/15/2003	FL	27.0	27		F	11/26/2003	Pt vaccinated with influenza 11/20/03, on 11/24/03 c/o headache and continued soreness,									U	11/20/2003	11/24/2003	4		MIL	MIL	Dostinex	NONE	UNK			1						1	Headache; Pain	FLU3~EVANS VACCINES~765753~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213954	12/15/2003	NY	1.0	1	.1	M	12/08/2003	Baby came in with fever, new ear infection, a couple of dots on body but also a 5cm cluster of red macules surrounding Prevnar injection site.									Y	12/05/2003	12/08/2003	3	NONE	PVT	PVT	NONE	Fever, new ear infection	Some ear infections, recent growth fall off			1						1	Rash macular	FLU3~SANOFI PASTEUR~U1291AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0410N~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~493187~4~IM~LA~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0410N~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0213955	12/15/2003	KS	10.0			M	10/27/2003	On the way out of the Dr office, pt c/o nausea, dizziness, being hot and cold, soreness in arm, headache.									Y	10/17/2003	10/17/2003	0		PVT	PVT		NONE	NONE			1						1	Dizziness; Feeling cold; Headache; Hot flush; Nausea; Pain	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~1~~~HEP A (NO BRAND NAME)~1	USA		Influenza
0213956	12/15/2003	MI	2.0	2	.4	F	12/08/2003	Hives and behavior change after flu vaccine 12/5/03. Tx Benadryl.				Y					Y	12/05/2003	12/07/2003	2	NONE	PVT	PUB	NONE	NONE	Amoxicillin allergy			1						1	Abnormal behaviour; Urticaria	FLU3~SANOFI PASTEUR~U1108AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213957	12/15/2003	MN	60.0	60		F	12/08/2003	Arm is swollen, tender to touch, warm (left arm). Was given Keflex 500 mg QID for 10 days.									U	10/28/2003	10/29/2003	1		PVT	OTH	Glucophage; ASA; Lisinopril; HCTZ	NONE	Hypertension, diabetes mellitus, menopause, allergic rhinitis			1						1	Feeling hot; Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~U1074AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~U059AA~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0213959	12/15/2003	OH	56.0	56		F	12/01/2003	3 hours after shot arm sore and red. 5 hours later arm beet red and super hot. Used ice packs to reduce heat and swelling. Next day still red and sore. Dr said not normal to have reaction to shot.									Y	10/16/2003	10/16/2003	0	NONE	PVT	PUB	See listing (NOT attached)	NONE	RA/Arachnoditis/Asthma/Osteoarthritis			1						1	Erythema; Injection site warmth; Oedema peripheral; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213960	12/15/2003	CA	55.0	55		F	12/08/2003	Got full blown flu within 24 hours. Lasted 3 days.									Y	12/04/2003	12/05/2003	1		PUB	PVT		NONE	NONE			1						1	Influenza	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213961	12/15/2003	MN	55.0	55		M	12/01/2003	Received influenza vaccine 11/28/2003 in AM. Woke up early AM 11/29/03 with severe itching of arm (left) and (left) hand/fingers. Upper arm became somewhat swollen, warm and red. Is much better now, still some itching and arm swelling.									Y	11/28/2003	11/29/2003	1	NONE	PVT	OTH	ALLOPURINOL, Triamterene	NONE	NONE			1						1	Erythema; Feeling hot; Oedema peripheral; Pruritus	FLU3~SANOFI PASTEUR~U1125AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213962	12/15/2003	CA	51.0	51		F	11/21/2003	Itching - hives and swollen face, mainly lips and eyes. Slight cough. Never felt throat closing off.									Y	11/19/2003	11/19/2003	0	NONE	PVT	OTH		NONE	Multiple food allergies with swelling of lips and eyes (uses Atarax prn)			1						1	Cough; Eye oedema; Face oedema; Pruritus; Urticaria	FLU3~EVANS VACCINES~766052~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213964	12/15/2003	NE	34.0	34		F	12/06/2003	Vaccine given within minutes pt said felt dizzy, nausea, hot, faint. Had her sit down, gave her some water. No problems with itching or breathing. After about 20 minutes she said she felt much better. I offered to call someone to drive her home. She said she was fine. I called her after 20 minutes from the time she left, she said she felt much better. Not having any other problems (she had my card with phone # and name). Called her again at home about 3 hours after initial vaccination. She said she was back to herself. Took about a total of an hour and a half to completely feel better.									Y	12/05/2003	12/05/2003	0		OTH	UNK	NONE	NONE	Allergic to penicillin			1						1	Dizziness; Feeling hot	FLU3~EVANS VACCINES~765979~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213965	12/15/2003	NY	53.0	53		F	12/08/2003	On 12/5/03 received flu vaccine, Aventis left deltoid, lot #U1097AA, exp. 30-06-04, and that evening noted raised itchy areas on arm. Sat 12/6 increased areas noted on chest and back. Referred to RNNP, Tx allegra, Benadryl									U	12/05/2003	12/05/2003	0		UNK	PVT		NONE				1						1	Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U1097AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213966	12/15/2003	NY	33.0	33		F	12/10/2003	Hive like reaction, encompassing only the upper left arm, where injection was given. Hives abated with use of 50 mg Benadryl PO after 1 hour.									Y	12/08/2003	12/10/2003	2	NONE	MIL	PVT	NONE	NONE	Allergic to penicillin			1						1	Urticaria	FLU3~EVANS VACCINES~765798~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213967	12/15/2003	NY	45.0	45		F	12/08/2003	Light rash on face and forearms relieved by 50 mg of Benadryl per mouth in 1 hour.  Rash occurred approximately 24 hours after injection.									Y	12/03/2003	12/04/2003	1	NONE	MIL	PVT	Birth Control Pill; Zoloft 25mg 1 per day	NONE	Allergic to Sulfa			1						1	Rash	FLU3~EVANS VACCINES~765798~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0213968	12/15/2003	CA	33.0	33		F	12/12/2003	Nosebleed, it was stoppable through pinching nose. Pt doesn't normally get nosebleeds.									Y	12/11/2003	12/12/2003	1	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Epistaxis	FLUN3~MEDIMMUNE VACCINES, INC.~500004P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0213969	12/15/2003	IA	9.0	9		F	12/05/2003	On the evening of the 28th the patient's arm became red and tender at the injection site.  It had some induration.  Recommended no boosters of pneumovax.				Y					Y	11/28/2003	11/28/2003	0		PVT	PVT	Singulair; Albuterol; Prilosec; Azmacoit; Clarinex; Lorazepam; Nortriptyline;	NONE	Asthma; Behavior problems			1						1	Injection site erythema; Injection site induration; Injection site pain	FLU3~EVANS VACCINES~765749~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0864N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0213970	12/15/2003	FL	61.0	61		F	12/14/2003	Chills, chest pain (right side), difficulty breathing 100 degree temperature, weakness, hoarseness awoke with symptoms 1-2 AM on 13th.  Feel weak but better 12/14 at 09:00.									Y	12/10/2003	12/13/2003	3	NONE	PUB	OTH	NONE	Almost recovered-5 day cold	NONE			1						1	Asthenia; Chest pain; Chills; Dysphonia; Dyspnoea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0214060	12/15/2003	MT	35.0	35		F	12/15/2003	Received flu shot on 11/03/03 and started having SOB, itchiness and hives on her neck and head the day after she received the vaccine. She did not seek treatment until 11/10/03 when the SOB started getting worse. Was seen in the ER and given a breathing treatment of albuterol.  She was to stay off work for three days. She is a known asthmatic.				Y					Y	11/03/2003	11/10/2003	7		PVT	UNK	unknown		asthma recent gastric bypass surgery       (30# weight loss)			1						1	Dyspnoea; Pruritus; Urticaria	FLU3~EVANS VACCINES~766050~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214061	12/15/2003	CO	2.0	2	.8	M	12/15/2003	Reported to PHN that child was seen at ER on 12/11 (2 days after receiving vaccination) for reddnes/rash on right arm. Reddness/rash extended approx. 6 inches around vaccination site down arm and also on posterior side of arm. Arm was warm to touch, but child had no systemic fevers. No other sx's noted. MD prescribed IV antibiotic that was admin. in ER (MOC did not know name of antibiotic). Child dc'd from ER/observation only tx prescribed. On 12/12, MOC noted reddness/rash on arm was gone and child had no sx's of distress. F/u with MD is scheduled for week of 12/15.				Y					Y	12/09/2003	12/11/2003	2	None.	PUB	PUB	None	None	Preemie-one month early		1	1						1	Injection site erythema; Injection site rash; Injection site warmth	DTAP~GLAXOSMITHKLINE BIOLOGICALS~594A2~4~IM~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1293AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214062	12/15/2003	MD	37.0	37		F	12/15/2003	We offered employees free flu vaccine.  Patient recd the flu vaccine 12/12/03. Rt arm, IM. She had received HBV left arm 12/11/03 by another employer. (Do not know HBV manufacturer name.) Patient advised me today (12/15/03) that Friday evening and Saturday her arm became swollen and sore.  By Sat. the left side of her right breast also became very tender and swollen. Very tender this a.m. when I checked her. I sent her to a clinic this a.m. 12/15/03 where she was seen by a CRNP who referred her to ER for IV therapy.  Patient has no primary care provider. Dx: Rt arm cellulitis; severe breast &arm/shoulder involvement & pain; axillary lymph node enlarged. She recd a HBV injection 12/11/03 in left arm as documented below. Done by another employer so I don't have knowledge of manufacturer etc. Signed consent form w/no contraindications.  Was 1st time she ever recd vaccine.				Y					U	12/12/2003	12/12/2003	0	To receive IV antibiotics in ER 12/15/03	UNK	PVT	unknown	None	none indicated on consent form			1						1	Breast tenderness; Cellulitis; Lymphadenopathy; Pain; Swelling	FLU3~SANOFI PASTEUR~01139AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214064	12/15/2003	CA	5.0	5		F	12/15/2003	Dry cough, fever of 102.2, malaise, runny nose started on 12/13/03, after receiving FluMist on 12/9/03. Treated with pediatric Robitussin for cough and cold plus Children's Motrin for fever. Symptoms ongoing as of 12/15/03.									N	12/09/2003	12/12/2003	3	None so far	PVT	PVT	Occasional Pediacare or Triaminic for cold symptoms	No	None			1						1	Cough; Malaise; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0214065	12/15/2003	MS	57.0	57		M	12/12/2003	Right arm reddened, warm, indurated deltoid area.  Area of redness 17cm X 17cm.  Also with fever and chills.									Y	12/08/2003	12/09/2003	1	none	PUB	PUB	none	none	allergies requiring shots		MS03100	1						1	Chills; Injection site erythema; Injection site induration; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U1293AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0685N~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U1010AA~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0214068	12/15/2003	WI	32.0	32		F	12/15/2003	13Dec03 (9:30 pm) Fever, chills, severe joint and musclar pain continued on and off thru out the nite. Soreness in left arm where influenza vaccine was administered.  14Dec03 (10:00am) Temperature 100.5, moderate aches thru out body. Neck felt very tender and swollen.  Breathing uncomfortable.  *Could not take a normal to deep breath without my neck and chest hurting.  3:00 pm  Felt tired and had aches in shoulder,rib, and mid back areas.  Temp. 98 2:30am - Pain in my neck and chest from breathing, woke me up from sleeping  15Dec2003  (5:30 am) Headache, Temperature 99.6, breathing again uncomfortable.  Sides of my neck really hurt along with breathing.  Tightness in chest/lower throat area when inhaling.				Y					U	12/12/2003	12/13/2003	1	Chest X-Ray - negative Blood work - negative Uninalysis - negative	PUB	UNK	Pre-Natal Vitamins		18 weeks pregnant  Allergic:  Penicillin(s)            Sulfa			1						1	Arthralgia; Chest discomfort; Chills; Fatigue; Headache; Injection site pain; Myalgia; Neck pain; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0214069	12/15/2003	TN	49.0	49		F	12/15/2003	Patient developed full body itch approximately 20 minutes after vaccination. Patient refused treatment here, but went home and took benadryl around the clock for 2 days for continued itching. She saw a slight rash and had slight chest tightness. She returned today and told me it was finally gone.									Y	12/11/2003	12/11/2003	0		UNK	PVT		Patient stated none				1						1	Chest discomfort; Pruritus; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500004P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0213775	12/16/2003	VA	6.0	6		M	12/10/2003	Fever 103-104 degrees. 10cm x 9cm erythema, tenderness at vaccine site.									U	12/08/2003	12/09/2003	1	NONE	UNK	UNK		NONE	ADHD			1						2	Oedema; Pain; Pyrexia; Injection site erythema; Pain; Pyrexia	FLU3~EVANS VACCINES~765665~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0214013	12/16/2003	MI	60.0	60		M	12/15/2003	Immediate red rash from elbow to shoulder left side which lasted 1 week. Arthralgias have persisted since day of shot (8 hours after shot).									U	11/20/2003	11/20/2003	0		PVT	OTH	NONE					1						1	Arthralgia; Rash erythematous	FLU3~EVANS VACCINES~765666~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214016	12/16/2003	IL	15.0	15		M	12/03/2003	Red rash over entire body starting 11/17/03. Pin size raised red.									Y	11/10/2003	11/17/2003	7	Strep throat and blood draw	OTH	PUB		NONE	Down syndrome, heart surgery, asthma			1						1	Rash erythematous	FLU3~EVANS VACCINES~765854~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214017	12/16/2003	AL	30.0	30		F	12/12/2003	Pt has seen family MD. Elidel cream, not working. A few red bumps around injection site still apparent after 1 month. Area is still red. It began as solid red circle and now is only a few red bumps. No other symptoms.				Y					U	10/30/2003	10/31/2003	1		OTH	PVT	NONE	NONE	NONE			1						1	Rash erythematous	FLU3~EVANS VACCINES~7659555~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214018	12/16/2003	KY	64.0	64		F	12/11/2003	Swelling in arm. Rash size of silver dollar with erythema.									Y	12/05/2003	12/05/2003	0		PVT	PVT		NONE	History of breast cancer, high cholesterol	~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Oedema peripheral; Rash erythematous	FLU3~EVANS VACCINES~766053~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214020	12/16/2003	MD	37.0	37		M	12/12/2003	Flu vaccine (Fluzone) was given 12/11/03 AM. In the afternoon, 12/11/03, around 5 PM after 1 hour nap, started feeling dizzy and having vertigo on and off. These symptoms continued and reported on 12/12/03. Ringing in the ear and fullness in the ear is reported.				Y					U	12/11/2003	12/11/2003	0		PUB	PUB	NONE		History of vertigo and dizziness approx 3-4 times/year for last 10 years			1						1	Dizziness; Ear discomfort; Tinnitus; Vertigo	FLU3~SANOFI PASTEUR~U1089AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214021	12/16/2003	WI	32.0	32		F	12/10/2003	Soreness, swelling to right upper and lower arm, axilla and right breast area. No redness. No treatment done. No fever noted.									N	12/05/2003	12/05/2003	0	NONE	PUB	PVT	Birth control pills	NONE	NONE			1						1	Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~U1172AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214022	12/16/2003	CO	10.0	10		F		Pt fainted, possibly because of mother's hold on the child and because child was holding her breath. Resolved after 5 minutes.									Y	11/24/2003	11/24/2003	0		OTH	OTH	NONE	NONE	NONE			1						1	Breath holding; Syncope	FLU3~SANOFI PASTEUR~1254AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214023	12/16/2003	AZ	2.0	2	.0	F	12/15/2003	Temperature 105 degrees the night of vaccinations and fever gone within 36 hours.				Y					Y	12/09/2003	12/09/2003	0	NONE	PUB	PVT		NONE	NONE			1						1	Pyrexia	FLU3~SANOFI PASTEUR~U1260AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0876N~1~~LL~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0214024	12/16/2003	OH	23.0	23		F	12/15/2003	12/11/03: Tetanus shot given. 12/12/03: Onset rash at site (left arm) along with tenderness. 12/15/03: Pt seen.									Y	12/11/2003	12/12/2003	1	NONE	PVT	UNK						1						1	Pain; Rash	FLU3~EVANS VACCINES~765877~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~SANOFI PASTEUR~U0824AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0214025	12/16/2003	NY	30.0	30		F	11/21/2003	Swelling, redness, rash, pain on upper arm (left). Seen in Urgent Care. Given Prednisone, Benadryl and an antibiotic. Restricted from work for 2 days. Symptoms resolved after 3 days.				Y					Y	11/18/2003	11/18/2003	0	None done	OTH	PVT		NONE	Hypertension, asthma			1						1	Erythema; Oedema; Pain	FLU3~SANOFI PASTEUR~765853~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0947N~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0214026	12/16/2003	GA	56.0	56		F		Very sore arm, welp, red, swollen for 6th day.									N	12/04/2003	12/05/2003	1		OTH	PVT		Shingles				1						1	Erythema; Oedema peripheral; Pain; Urticaria	FLU3~SANOFI PASTEUR~U1254AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1119M~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0214027	12/16/2003	WI	64.0	64		F	12/12/2003	Sore throat, swollen glands (neck), achy bones, teeth hurt, head hurt, fever/chills, eyes sensitive, very weak, headache, effort to move, cough, sneezing, fast pulse 80-100 for 3 days, pale, slept and slept day and night, still need naps. After 12 days, still not feeling normal: some sore throat, coughs, sneezing, nose running.									Y	11/28/2003	12/01/2003	3		PUB	PVT	NONE	NONE	NONE			1						1	Asthenia; Cough; Headache; Heart rate increased; Lymphadenopathy; Pain; Pallor; Pharyngolaryngeal pain; Photophobia; Pyrexia; Rhinorrhoea; Sneezing; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0214028	12/16/2003	MN	1.33	1	.4	M	12/11/2003	1500 12/5: croupy cough, runny nose, felt warm. 1900 12/5: given acetaminophen and albuterol neb, vomit x3. 2015 12/5 just fell asleep; 30 seconds uncontrolled twitch; blue at mouth and eyes; sleepy after episode; sporadic twitch 20 minutes.				Y					Y	12/04/2003	12/05/2003	1	Blood culture negative for 48 hours. Hgb 13.6. WBC 18,000. Na+ 138, K+ 4.4, Cl- 105, CO2 18, glucose 105, BUN 14, creat 0.2.	PVT	PVT	NONE	Strep 11/17/03	31 week prematurity; apnea;  hx reactive airway			1						1	Cough; Croup infectious; Cyanosis; Feeling hot; Muscle twitching; Rhinorrhoea; Somnolence; Vomiting	FLU3~SANOFI PASTEUR~U1128AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0372N~3~IM~LL~HEP B (FOREIGN)~1|PNC~PFIZER\WYETH~493507~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0214030	12/16/2003	OK	36.0	36		M	12/10/2003	Rash occurred 1st on hands, then left wrist and arm, groin and right leg. Went to private physician, treated with Benadryl. Dr viewed rash.				Y					U	12/09/2003	12/09/2003	0		PUB	UNK	NONE	Sore throat	Rubella vaccination	legs swollen~Rubella (no brand name)~~0.00~In Patient		1						1	Rash	FLU3~SANOFI PASTEUR~U1271AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214031	12/16/2003	CA	1.25	1	.3	M	12/09/2003	Left thigh, red, hot, swollen and tender.									Y	12/02/2003	12/04/2003	2		PVT	UNK		NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site warmth; Pain	DTAP~GLAXOSMITHKLINE BIOLOGICALS~592A9~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~~UNK~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0178N~2~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0196N~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0214033	12/16/2003	MA	32.0	32		M	12/11/2003	Pt received shot in left arm. 12/9/03 AM, pt felt symptoms begin: sore throat, chest wheeze, no appetite.									U	12/08/2003	12/09/2003	1		OTH	PVT	NONE	NONE	NONE			1						1	Anorexia; Pharyngolaryngeal pain; Wheezing	FLU3~EVANS VACCINES~765855~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214034	12/16/2003	WA	37.0	37		F	12/09/2003	Right arm with slight discomfort day after injection. 3 days later it started to swell and has been progressively getting more swollen. On day seen 12/9/03 5cm of induration/warmth. Zyrtec 10mg po qd. NSAID, Keflex 500 po tid for 10 days, pt to phone follow-up.				Y					U	12/03/2003	12/04/2003	1	NONE	PVT	UNK		NONE	Pt thought she had a h/o arm pain with Td in the past. No h/o swelling.			1						1	Discomfort; Feeling hot; Injection site induration; Oedema peripheral	FLU3~EVANS VACCINES~765878~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~SANOFI PASTEUR~U0998AA~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0214035	12/16/2003	WA	23.0	23		F	12/02/2003	Pt states she woke up 11/05/2003 at 6AM feeling weak, congested, wheezing and pale.  Denies asthma.  Says she felt like she had the 24 hour flu.  Took Nyquil at 21:00 11/05/03 then went to bed.  Awoke on Thurs 11/06 feeling better. Complained of congestion and runny nose.									Y	11/04/2003	11/05/2003	1	NONE	OTH	OTH	Prozac; Desogen;	Just gotten over a cold	NONE	Left arm~Tetanus Toxoid (no brand name)~4~4.00~In Patient		1						1	Asthenia; Nasal congestion; Pallor; Rhinorrhoea; Wheezing	FLU3~SANOFI PASTEUR~U1271AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214036	12/16/2003	DC	58.0			F	11/26/2003	Pt reported to health unit with left arm pain; onset after receiving influenza vaccine a few hours earlier.  Pt given Motrin 800mg per mouth three times per day.  Two hours later, she presented again with arm pain worsening, and onset of left side neck pain.  Treatment: Decadion injection and oral Prednisone for 2 days.				Y					Y				NONE	OTH	OTH	Mefloguine	NONE	NONE			1						1	Injection site pain; Neck pain	FLU3~EVANS VACCINES~765754~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214037	12/16/2003	UT	34.0	34		M		Developed cellulitis around injection site.  Had erythema, tenderness, warmth.  Resolved with course of antibiotics (oral), over 3 days.				Y					Y	11/10/2003	11/10/2003	0	NONE	OTH	MIL	NONE	NONE	NONE			1						1	Cellulitis; Injection site erythema; Injection site reaction; Injection site warmth; Tenderness	FLU3~EVANS VACCINES~765756~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214038	12/16/2003	ME	44.0			M	12/09/2003	Approximately 10 minutes after injection in right deltoid, patient came back from waiting room saying head feels fuzzy, also feels like the right side of throat, pt given O2 at 14:00.  Rescue called, no transport needed.									Y				Anxiety?	PVT	PVT	NONE	NONE	Muscular Dystrophy			1						1	Anxiety; Feeling abnormal	FLU3~EVANS VACCINES~765955~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214039	12/16/2003	WV	24.0	24		M	12/08/2003	ER visit with vomiting and nausea.				Y					Y	12/05/2003	12/06/2003	1	NONE	OTH	MIL	NONE	NONE	NONE			1						1	Nausea; Vomiting	ANTH~EMERGENT BIOSOLUTIONS~FAV081~2~SC~~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1014AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~HAB2399A4~2~IM~~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~HAB2399A4~2~IM~~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0214040	12/16/2003	TX				M	12/08/2003	Next day after flu, pneumonia and tetanus shots I began getting sick and my arm was sore for a week, I went to MD and she said I had pneumonia.									Y	10/27/2003	10/28/2003	1	X-Ray-Pneumonia	PUB	OTH	NONE	NONE	NONE			1						1	Malaise; Pain; Pneumonia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0214041	12/16/2003	WI	47.0	47		F	12/08/2003	There was moderate bleeding at the injection site (right deltoid muscle) when the vaccine was administered.  Approximately two hours after the injection severe burning pain was noted radiating down the right arm, up the right side of the neck and down the right side of the back.  This severe pain lasted approximately 48 hours then gradually decreased over about 4 weeks.  Weakness in the right arm was noted when performing certain activities or when the arm was held in certain positions.  Severe discomfort of the right arm was noted when lying on the right side; so uncomfortable as to be unable to sleep lying on the right side.  There was soreness at the injection site but no redness or bruising was noted.  No fever developed and no other unusual symptoms were noted.  The pain was treated w/Ibuprofen 400-600mg per mouth Q&H for approximately 48 hours and then two times pm.									Y	11/07/2003	11/07/2003	0	Tuberculin test negative 11/10/2003	PVT	PVT	Tuberculin Skin Test (Parkedale, Lot # 001D2P, right forearm, 4 previous doses); Theophylline 300mg per mouth 2 times a day; Belclomethasone Inhaler 2 puffs two times a day;	NONE	Asthma			1						1	Asthenia; Injection site pain; Skin burning sensation	FLU3~EVANS VACCINES~765854~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214042	12/16/2003	TX	49.0	49		F	12/09/2003	Day after vaccination, at around 10:00, complained of feeling hot with body aches itching, wheezing, chest tightness/congestion/coughing. By that evening had 104 F fever, chills not relieved with Tylenol and for ibuprofen until the next day.									Y	12/02/2003	12/03/2003	1	NONE	PUB	PVT	Previoiusly on BP meds, none at time of vaccine.	NONE	History of seasonal allergies, asthma			1						1	Chest discomfort; Chills; Cough; Feeling hot; Nasal congestion; Pruritus; Pyrexia; Wheezing	FLU3~EVANS VACCINES~765874~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214071	12/16/2003	MN	9.0	9		M	12/16/2003	Had vaccine at 4PM 12/12/2003; by morning of 12/13/03 had chills, fever about 102 degrees, complained of muscle and/or joint soreness, and was listless.  Fever varied between 101 and 103 until pre-dawn 12/15/2003. Midnight dose of ibuprofen on 12/14/2003; and midnight dose of aceteminophen on 12/15/2003.									Y	12/12/2003	12/13/2003	1		PVT	UNK	None	None	None			1						1	Arthralgia; Chills; Listless; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0214126	12/16/2003	MO	8.0	0	.8	M	12/16/2003	After the first shot on Nov. 13th., he said he saw black and white spots, felt hot and dehydrated.  After the second shot at 9:00 a.m. Dec. 15th, he reported having a swollen throat.  He woke up the next morning at 6:00 with hives(itchy splotches that caused his eyelids to swell) all over his body and had a fever of 100.2.									U	12/15/1995	12/16/1995	1	I am reporting this on Dec. 16th, the morning of the symptoms so I anticipate full recovery. Just want side effects known as last month exit sheet at doctor's office said no side effects	PVT	PVT	No.  Gave him children's motrin for fever.	no	none			1						1	Dehydration; Eyelid oedema; Feeling hot; Pharyngeal oedema; Pyrexia; Urticaria; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~U1074AA~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0214127	12/16/2003	MD	57.0	57		M	12/16/2003	Pt. returned to clinic on 12/12/03. Left Deltoid where pt. received flu vaccine was a 2 1/2 in.reddened area.  Pt. reports only slight soreness at needle site.  No edema or pain.  Robust reaction to vaccine.  No treatment necessary.  Told to return to clinic with any S/S of infection or seek medical attention at ED or PMD.									Y	12/08/2003	12/11/2003	3	N/A	PUB	PUB	no	client reports well at time of vaccination	not allergic to eggs			1						1	Erythema; Injection site pain	FLU3~SANOFI PASTEUR~U12887AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214128	12/16/2003	MS	66.0	66		M	12/12/2003	Patient woke 10:30 pm 12/7/03 with itching between fingers, on wrists and arms.  Today 12/12 is also itching and rash between thighs.  Denies any problems  with breathing or swallowing.  Denies any egg allergy, drug allergy, or environmental allergy				Y					Y	12/04/2003	12/07/2003	3	None	PUB	PUB	none	none	none		MS03101	1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~Aventis~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0685N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0214129	12/16/2003	WI	19.0	29		F	12/16/2003	Develop hives on 12/14/2003 was seen in the clinic on 12/15/2003.  Exam showed urticaria on face, arms, chest, back and legs. Lungs were clear no sign of any respiratory component.  Family history positive for food allergy (mom had food allergies.  The patient had never had any reaction to foods.  No new foods in the last 48hrs befor her urticaria started. Patient started on prednisone 40mg PO BID for 5 days.  Has recovered.									Y	12/11/2003	12/14/2003	3		UNK	UNK	None	None	None			1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~50020P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0214131	12/16/2003	NC	3.0	3		M	12/16/2003	A cluster of hives (small red bumps) developed on the palm and wrist of the left hand within 2 days of the flu vaccination. The vaccination was administered on December 8, 2003. As of today, December 16, 2003, the cluster of hives is almost gone.									Y	12/08/2003	12/10/2003	2		PUB	PVT	NO	NO	NO			1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0214132	12/16/2003	CA	62.0	0	.7	F	12/16/2003	Vascular Dermititis on leg and blood in urine. Nurse follow up on 05/18/04: Itching.									Y	10/28/2003	10/30/2003	2	Urinalysis, Blood test, Referred to dermatolagist also, sonagram of kidney.  Nurse follow up on 05/18/04: Hematuria	PVT	PVT			Allergic reaction to the latex in bandaids, neosporin, sulpha, erythromyacin			1						1	Blood urine; Dermatitis; Haematuria; Pruritus	FLU3~EVANS VACCINES~7165667~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214133	12/16/2003	AZ	14.0	14		M	12/16/2003	Inhaled vaccine 12/12/2003 at 5:30pm. Patient threw up 4 hours later.  12/13 - cough and sore throat. 12/14 - runny nose and chest congestion. 12/15 - congestion and green phlegm coughed up 12/16- same as 12/15.  Out of school 12/14 and 12/15. He is tired.									U	12/12/2003	12/12/2003	0		UNK	PVT	N/A	none	n/a			1						1	Cough; Fatigue; Nasal congestion; Pharyngolaryngeal pain; Rhinorrhoea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500003P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0214073	12/17/2003	NY	65.0	64		F	12/14/2003	Patient admitted to hospital on 11/8/03 (8:39 PM). Patient presented with fever (105), generalized erythema, chills, SOB, semi-conscious state. Patient also hypoxic and had ischemia on fingers. Patient was intubated.	Y	11/09/2003			Y	1			N	10/28/2003	11/08/2003	11	LP, CSF culture; Blood culture; Urine culture; Blood culture grew gram positive cocci in pairs and chains. Diagnosis - TSS. Cause of death - Sepsis.	PVT	UNK		NONE	Cardiomegaly; Obesity			1						1	Chills; Depressed level of consciousness; Dyspnoea; Erythema; Hypoxia; Peripheral vascular disorder; Pyrexia; Sepsis	FLU3~SANOFI PASTEUR~U1124AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0214076	12/17/2003	NJ	47.0	47		F	11/17/2003	5 hours after injection pt experienced soreness at injection site, increased soreness/stiffness in right upper arm with extension of arm. Denies fever, redness, states no relief from discomfort from pain. Small area of induration. Discomfort persisted for 72 hours. Pt called private MD who stated this was NOT allergic reaction; MD stated was common side effect.									Y	11/08/2003	11/08/2003	0		PUB	PUB	Wellbutrin	NONE	NONE		200327	1						1	Discomfort; Injection site induration; Musculoskeletal stiffness; Pain	FLU3~SANOFI PASTEUR~U1145AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0265N~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0214077	12/17/2003	NJ	73.0	73		M	11/07/2003	Pt reports achy on Sat evening (body) 11/1/03. On 11/2 stiff neck (L) and back, left upper shoulder and arm, elbow pain, persisted 11/2-11/5, took Aleve and hot packs. Good movement, ROM better today. If not improved next week to contact MD.									U	10/30/2003	11/02/2003	3		PUB	PUB	NONE	NONE	NONE		200328	1						1	Musculoskeletal stiffness; Pain	FLU3~EVANS VACCINES~765413~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214078	12/17/2003	NJ	41.0	41		F	11/07/2003	(That AM) pt reports had slight stiff neck before vaccine. After vaccine site hurt. Pain from shoulder blade area (L) to upper arm to elbow. No loss of motion. Ibuprofen helps somewhat. If not improved will see PMD next week.									U	10/30/2003	10/31/2003	1		PUB	PUB	Ibuprofen for heel spur		Environmental (poss sulfites)		200330	1						1	Injection site pain; Musculoskeletal stiffness; Pain	FLU3~EVANS VACCINES~765413~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214079	12/17/2003	NJ	70.0	70		F	11/07/2003	Pt reports painful left upper arm after receiving vaccine. Next day took Aleve. Pain from upper arm to elbow, hurts when moves hand in circle. Much improved today. If not improved will contact MD next week.									U	10/30/2003	10/31/2003	1		PUB	PUB	Baby ASA	NONE	NONE		200329	1						1	Pain	FLU3~EVANS VACCINES~765413~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214080	12/17/2003	WA	10.0	10		M	11/25/2003	Pt received Influenza vaccine for the first time. About five minutes later, the pt c/o dizziness and feeling lightheaded. He remained seated while I checked his vital signs and offered him a cool towel and a glass of water. The supervisor was notified and another staff person and I assisted the pt to an exam table in the room next door. The pt drank more water and juice and rested in a semi-recumbent position with his legs elevated until he said he felt better and his color returned. The pt was escorted from the office about 30 minutes later, with his mother and siblings.									Y	11/24/2003	11/24/2003	0	NONE	PUB	PUB	NONE	NONE	NONE		WA031983	1						1	Dizziness	FLU3~SANOFI PASTEUR~U1277AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214081	12/17/2003	WA	67.0	66		M	11/04/2003	Pt c/o fever, chills, aching 102 degrees temp. starting Saturday 11/1/03. Received immunizations 10/31/03.									Y	10/31/2003	11/01/2003	1	NONE	PUB	UNK	NONE	NONE	NONE		WA031978	1						1	Chills; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1091AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0740N~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0214082	12/17/2003	WA	64.0	64		F	10/31/2003	2 days after flu vaccine painful swollen area at site of injection right arm. Resolved after 4 days. At midnight 10/31/03 experienced severe shaking (unable to pour water without spilling) as if cold yet tops of arms and legs warm. Shaking resolved only after 3 hours and returning to bed with extra blankets. Awoke with severe headache, nerves sensitive, no energy and still feels this way at 9:45 AM at time of call.									N	10/23/2003	10/25/2003	2	NONE	OTH	PVT	NONE	NONE	NONE		WA031977	1						1	Headache; Injection site oedema; Nervousness; Pain; Tremor	FLU3~SANOFI PASTEUR~U1132AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214083	12/17/2003	WA	59.0	59		F	11/21/2003	Chilling day of vaccination, took Tylenol and did sponge bath. T about 103-104.									Y	11/20/2003	11/20/2003	0		PUB	UNK	Zocor, Warfarin, Topram for heart, ASA	NONE	Pacemaker		WA031979	1						1	Feeling cold; Pyrexia	FLU3~SANOFI PASTEUR~U1277AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214084	12/17/2003	WA	24.0	23		F	11/20/2003	Tingling and numbness in her legs, difficulty walking. Saw doctor on 11/19 AM who dx'd a virus in her spine. Drew blood. Started in one foot then leg, then the other leg, then from waist down off and on.				Y					Y	11/06/2003	11/18/2003	12	Spine X-ray, blood for inflamm.	PUB	PVT		May have started at vaccination	NONE		WA031980	1						1	Difficulty in walking; Hypoaesthesia; Paraesthesia; Viral infection	FLU3~SANOFI PASTEUR~U1277AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214085	12/17/2003	CT	68.0	68		F	12/05/2003	A few days after I received the vaccine I noticed a rash on my left arm that soon became itchy. A few days later the rash was on my stomach and itchy and again a few days later on my left leg. I was overseas at the time and when I arrived home about 2 1/2 weeks after the shot, my doctor prescribed prednisone. Cleared up.									Y	10/28/2003	10/31/2003	3		PUB	PUB			Mold, dust, cats, penicillin (hives), Claritin (hives)			1						1	Pruritus; Rash	FLU3~EVANS VACCINES~765745~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214086	12/17/2003	CT	64.0	64		M	12/05/2003	Hives immediately after receiving vaccine.				Y					Y	11/11/2003	11/11/2003	0		PUB	PUB		NONE	NONE			1						1	Urticaria	FLU3~EVANS VACCINES~765745~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214087	12/17/2003	TX	16.0	16		M	12/07/2003	Pt had immediate tingling and numbness down the arm and in the hand of the vaccinated arm (left side). Symptoms resolved within 3 hours. The follow up received on 12/23/03 states pt had tingling down the vaccinated rm starting w/in 10 minutes post vaccination lasting approx 2-3 hrs and resolved on its own.									Y	12/07/2003	12/07/2003	0		OTH	PVT		NONE	NONE			1						1	Hypoaesthesia; Paraesthesia	FLU3~SANOFI PASTEUR~U1170AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214088	12/17/2003	SD	0.67	0	.7	F	12/09/2003	30-45 minutes after flu vaccine administered broke out with rash/hives. Mother contacted husband who returned to home. Child with HR 148, irritable, T 97.2. Benadryl 0.14cc (50mg/cc) given IM RT. Symptoms resolved within 1 hour. MD at ER informed of reaction and treatment.									Y	12/05/2003	12/05/2003	0	NONE	OTH	OTH	Iguprofen, Amoxicillin; cough syrup	Otitis media, URI	Previous otitis media, bronchiolitis, no allergies			1						1	Heart rate increased; Irritability; Pyrexia; Rash; Urticaria	FLU3~SANOFI PASTEUR~U1128AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214089	12/17/2003	OH	3.0	3		M	12/09/2003	Vomiting, clear liquid, no fever, chills or diarrhea. Was in ER twice and then encouraged to go to another hospital where he was in ER.				Y					Y	12/03/2003	12/06/2003	3	UNK	PUB	OTH	NONE	NONE	NKA, no birth defects or medical conditions	~Influenza (Seasonal) (no brand name)~1~3.00~In Patient		1						1	Vomiting	FLU3~SANOFI PASTEUR~U1260AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214090	12/17/2003	UT	55.0	55		F		Complaints of itching/tightness shortly after receiving vaccination. There was diffuse, broad edema and mild erythema around injection site over left upper arm. Given Zyrtec 10mg, ice.				Y					Y	11/10/2003	11/10/2003	0	NONE	OTH	MIL	Inderal	NONE	Allergies: CT dye, Wellbutrin, triple Abx cream, sulfa, weeds, grasses			1						1	Injection site erythema; Injection site oedema; Pruritus	FLU3~EVANS VACCINES~765756~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214091	12/17/2003	GA	46.0	46		F	12/10/2003	Breathing difficult, fluid in lungs, flu like symptoms, edema - body. Symptoms 1 week flat of back.									Y	11/22/2003	11/22/2003	0		OTH	OTH			Egg allergies			1						1	Dyspnoea; Influenza like illness; Oedema	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0214092	12/17/2003	NY	4.0	4		F	12/16/2003	Vagal, hypotensive, LOC for 5 minutes. Hives.				Y					Y	12/12/2003	12/12/2003	0		PVT	PVT	NONE	NONE	Prematurity 28 weeks, anemia			1						1	Anaemia; Hypotension; Loss of consciousness; Syncope vasovagal; Urticaria	FLU3~SANOFI PASTEUR~U1230AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214093	12/17/2003	ID	37.0	37		F	12/15/2003	C/o sore left deltoid muscle since getting the flu vaccine. Denies any redness or swelling at the site.									U	11/06/2003				PVT	UNK						1						1	Myalgia	FLU3~SANOFI PASTEUR~U1091AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214095	12/17/2003	IL	1.5	1	.5	F	12/15/2003	12/9/03 1050: Temp 103.5 ax. 12/9/03 1700: Temp 104.2 ax. 12/10/03: Temp 101.6 ear. Seen in ER with rigors and febrile seizure. Given Tylenol/Ibuprofen prn. Medical records state dragging leg and rhinorrhea.				Y					Y	12/08/2003	12/09/2003	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Chills; Convulsion; Gait disturbance; Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1115AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UA811AA~3~IM~LL~HIB (PROHIBIT)~1|VARCEL~MERCK & CO. INC.~0504M~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0214096	12/17/2003	UT	10.0	10		F	12/09/2003	Left arm is numb from shoulder to palm and there is an aching in the arm. Has full motor ability. 12/11/03 called, arm better a little, sore but no numbness left.									Y	12/08/2003	12/09/2003	1		PUB	PUB		NONE	NONE			1						1	Hypoaesthesia; Oral pain; Pain	FLU3~EVANS VACCINES~765980~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214098	12/17/2003	GA	4.0	4		F	12/08/2003	Redness and swelling to right arm 24 hours after immunizations.				Y					U	12/03/2003	12/05/2003	2		PVT	PUB		Asthma; Allergic rhinitis	NKDA			1						1	Erythema; Oedema peripheral	DTAP~SANOFI PASTEUR~U1007DA~6~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1132AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W1619~5~SC~RA~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0393N~3~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0214099	12/17/2003	NY	1.33	1	.3	F	12/11/2003	Urticaria 5-10 minutes after administration of DTaP and flu vaccine. Benadryl given - hives resolved in 30 minutes.									Y	12/11/2003	12/11/2003	0		PVT	UNK		NONE	NONE			1						1	Urticaria	DTAP~SANOFI PASTEUR~C1527AA~4~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1148DA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE085AA~4~IM~RA~HIB (PROHIBIT)~1	USA		Influenza
0214100	12/17/2003	UT	37.0	37		F		Swelling and redness at injection site with itching of skin on trunk and other extremities.  Zyrtec for itching.				Y					Y	11/14/2003	11/14/2003	0	NONE	OTH	MIL	Premarin	NONE	PCN; Keflex; Sulfa			1						1	Injection site erythema; Injection site oedema; Pruritus	FLU3~EVANS VACCINES~765756~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214101	12/17/2003	UT	44.0	44		F	11/28/2003	Mild swelling, soreness at injection site.  Probably normal reaction.  No tx needed.				Y					Y	11/24/2003	11/24/2003	0	NONE	OTH	MIL	Motrin; Altale	NONE	PCN			1						1	Injection site oedema; Injection site pain	FLU3~EVANS VACCINES~765756~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214102	12/17/2003	UT		45		F	11/26/2003	Swelling, redness, warmth around injection site a few hours after vaccination given.  Given antibiotics for cellulitis, condition improving.				Y					U	11/24/2003	11/24/2003	0	Still recovering	OTH	MIL	NONE	NONE	Chronic Bronchitis			1						1	Cellulitis; Injection site erythema; Injection site oedema; Injection site warmth	FLU3~EVANS VACCINES~765756~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214103	12/17/2003	NM	62.0	62		F	12/01/2003	Started 11/05: Sore throat, itching, lots of phlegm, coughing, lower back pain, joint pains, shortness of breath.  Jaws, eyes, headache, very miserable.  Felt like very irritable just plain sick!  Arms sore, hot and cold chills 11/06/2003, ER visit to MD 11/07/2003 & 11/11/2003.  Recovered: 12/03/2003.				Y					Y	11/04/2003	11/05/2003	1	NONE	PUB	OTH	NONE	NONE	NONE			1						1	Arthralgia; Back pain; Chills; Cough; Dyspnoea; Headache; Irritability; Mucosal inflammation; Pharyngolaryngeal pain; Pruritus	FLU3~SANOFI PASTEUR~U1143AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|TTOX~SANOFI PASTEUR~U1011AA~UNK~IM~~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0214161	12/17/2003	MI	26.0	26		M	12/17/2003	Member states of having symtoms of Fatigue, Headache,Dizziness,Low back pain,Slight fever,Numbness of the hands,Memory loss,Nausea and Diarrhea,Shortness of breath and blurred vision. Member begin to have symtoms two days after the anthrax shot. Patient received his fourth vaccination.The area of the vaccination was the size of a softball in accordance to the emergency room visit on 09 Dec 03. Member continues to have similiar symtoms after ER visit and was seen again on 15 Dec 03. Member was presribed medication again and released.				Y					N	12/07/2003	12/08/2003	1	None	MIL	MIL	None	None	Tendonitis of Right Ankle x two years Member has no arch of both feet.			1						1	Amnesia; Back pain; Diarrhoea; Dizziness; Dyspnoea; Fatigue; Headache; Hypoaesthesia; Injection site oedema; Nausea; Pyrexia; Vision blurred	ANTH~EMERGENT BIOSOLUTIONS~FAV081~4~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~EVANS VACCINES~765754~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214162	12/17/2003	UT	64.0	64		M	12/17/2003	Client states R. arm was sore x5 days following injection. States soreness then radiated into back muscles.  States he has seen a M.D. and a homeopathic for this incident and is currently participating in physical therapy for past several weeks.									U	10/15/2003	10/16/2003	1	No mention of any tests	PUB	PVT	Received lupron in 03/03 and takes zocar.	Prostate Cancer in remission	Has been treated for prostate cancer and monitored x11 years.			1						1	Pain	FLU3~SANOFI PASTEUR~U1092AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214163	12/17/2003	MS	10.0	10		F	12/17/2003	Dizziness within 3 hours of shot given at approx 4:30 pm Dec 15th continues on to today Dec. 17th. Dizziness is mild.   #9 I wrote unknown as my daughter continues to be dizzy as I submit this report.									U	12/15/2003	12/15/2003	0		MIL	MIL		None	allergy to nickel - dermatitis			1						1	Dizziness	FLU3~SANOFI PASTEUR~U11147AA~1~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214166	12/17/2003	MN	34.0	34		F	12/17/2003	Tachycardia, HR 130's, tremors, shortness of breath. The medical record received on 2/17/04 states arm numb.				Y					Y	12/17/2003	12/17/2003	0	telemetry monitoring	PUB	UNK	albuterol, advair, ritalin, allesse, claritin d, accolate		Asthma, migraines, allergic to pcn, dystonic reaction to compazine			1						1	Dyspnoea; Heart rate increased; Paraesthesia; Tachycardia; Tremor	FLU3~SANOFI PASTEUR~U1267AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214171	12/17/2003	PA	42.0	42		M	12/17/2003	Patient developed chest pain and shortness of breath 55 days after smallpox vaccination ( revaccinee).  Hospitalized.  Patient had abnormal EKG and normal cardiac enzymes.  Echocardiogram showed akinetic inferior septum and inferior wall, LVEF =40-45%.  Cardiac cath showed normal cardiac enzymes and left ventriculogram showed LVEF =42%.  Diagnoses with mild cardiomyopathy					Y	3			Y	03/05/2003	04/29/2003	55	echocardiogram on 5/08/03 normal	MIL	MIL						1						1	Cardiomyopathy; Chest pain; Dyspnoea; Electrocardiogram abnormal	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~UNK~~~MENINGOCOCCAL (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0214172	12/17/2003	GA	52.0	52		M	12/17/2003	Patient developed eczema type break-out all over his body. Patient had been diagnosed this year with eczema. Patient went to his Dermatologist who now treating him with steroids. Patient questions the dry heat in his house as being a probabal cause. He received the flu shot from us on October 3,2003 but this was reported to my office on December 16, 2003. I am reporting this because patients Dermatologist said the flu shot gave him the outbreak.				Y					Y	10/03/2003	12/16/2003	74		UNK	PVT	unknown	unknown	unknown			1						1	Eczema	FLU3~EVANS VACCINES~765495~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214173	12/17/2003	IA	7.0	6		M	12/17/2003	Within four hours of vaccine, he had a fever of 102.5. The next day, his tonsils were swollen with white spots in addition to the fever. That night, he began vomiting. Two days later, his fever spiked to 105.1 in the middle of the day. Until he was admitted, we were using tylenol/Motrin for his fever. On day three he was given amoxicillin for strep, even though the strep test came back negative. Day four he was admitted to the hostpital. During the stay at the hospital, he was given a IV fluids, a variety of antibiotics, rocephin, and decadron (sp?) to reduce the swelling of his tonsils. The medical records received on 1/28/04 states dehydration.				Y	Y	2			Y	12/09/2003	12/09/2003	0	Chest x-ray, blood cultures, CBC, mono test, strep test	UNK	UNK		None	Allergic to nickel (dermatitis on belly from snaps on jeans). This was his second flu shot this year (the first was on 10/30/03) since this was his first year of getting the flu shot.  He reacted the same way (high fever - 104.4 - swollen tonsils with white spots, body aches) with the first one, but it only lasted about four and a half days.  The hosptial ER said there was no way			1						1	Dehydration; Pharyngitis; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1290AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0214174	12/17/2003	FL	18.0	18		F	12/17/2003	Sore throat, neck pain, chills, tired, slight rash (splochy red marks) on chest.									Y	12/17/2003	12/17/2003	0	None	PVT	PVT	Fastin Recently stopped taking: Glucophage and Progesterine	No	Endometriosis, medical allergy to sulpher medications			1						1	Chills; Fatigue; Neck pain; Pharyngolaryngeal pain; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0212869	12/18/2003	NC	54.0			M	05/28/2004	From initial information received on 12/08/03 through an enhanced surveillance program conducted by the CDC (VAERS # 212869), it was reported that a 54 year old male pt received several vaccinations including a dose of Yellow Fever Vaccine (lot number, manufacturer, route and site of administration not reported) and a dose of Smallpox vaccine (lot number, manufacturer, route and site of administration not reported) on 02/15/2003.  The pt was hospitalized and diagnosed with MI on 10/03/03.  It was not reported whether the pt recovered.  No other information was provided at this time. From additional info received on 12/15/03 from CDC, a copy of the VAERS form filled out by the initial reporter was provided. The responsible physician, vaccine administered by, and initial reporter info was provided. The pt received a concurrent immunization with Yellow Fever vaccine, meningococcal vaccine, smallpox vaccine, influenza vaccine, hep B vaccine, hep A vaccine and anthrax vaccine on 2/15/03. The pt also received two separate doses of anthrax vaccine on 2/2/03 and 3/5/03 respectively. Reportedly, the pt stated that he was concerned that the vaccination he has received may have contributed to his cardiac problems. He had a history of hyperlipidemia and degenerative joint disease/osteoarthritis. The pt stated that he sometimes became short of breath after exercise, but that this was baseline for him. He recalled feeling a heartburn while resting on 10/2/03, which he described as a strong urge to burp, but he was unable to do so. Reportedly, the pt described the sensation as a burning feeling in the middle of his chest and rated it as a six out of ten on a pain scale. The pt's medical records report that he had experienced intermittent chest pain/ pressure at rest for two to three weeks. The pt was seen in the ER where he was diagnosed with a myocardial infarction. HE had elevated cardiac enzymes, initial EKG with ST elevation in Lead III, and subsequent T-wave inversion in leads, II, III, and AVF. The pt was hospitlaized and underwent a cardiac catheterization with stent placement. Mild posterior wall hypokinesis was revealed. The left heart catheterization and left ventriculogram and coronary angiogram revealed severe two-vessel coronary artery disease with the right coronary artery being the culprit of th ept's recent non-Q myocardial infarction. The left anterior descending artery is very small caliber. Not optimal for surgical intervention. Normal left ventricular systolic function. A radiologic examination was performed on 9/22/03, which revealed the lungs to be midly hyperinflated, but clear of infiltrate. Laboratory testing was performed. Since discharged from the hospital, the pt denied any further chest pain or heartburn type symptoms. The impression from the cardiolite scan was abnormal myocardial perfusion studyw ith ischemia in the inferolateral wall region. The pt and was scheduled for another stress test on 11/15/03. The pt's recovery status is currently unknown. No other info was provided at this time.  Follow up on 01/12/04: ON 02/02/03 the pt was vaccinated SC with a first dose of anthrax vaccine (Biothrax, batch # FAV073).  On 02/15/03 the pt was vaccinated IM with a first dose of hepatitis A vaccine (inactive)(Lot # 644168/0980M), a first dose given IM of hepatitis B virus vaccine rHBsAg (yeast)(batch #5377AA)(manufacturer unknown), a first dose given SC of Yellow Fever virus vaccine (Batch#UB358AA), a second dose given ID in the left arm of SP (Dryvax, batch #4020071), a first dose given SC of meningococcal ACYW polysaccharide vaccine (Menomune-a/c/y/w-135)(batch @ UB269AA), a third dose given IM of influenza virus vaccine (unspecified), and a second dose given SC in the left arm of ANA.  On 03/05/03 the pt was radiologic examination revealed the lungs to be mildy hyperinflated but clear of infiltrate.  The heart and pumonary vessels appeared to be normal size.  The impression was a non-specific hyperinflation and focal degenerative changes of the left distal clavicle of the AC joint.  On 10/02/03 the pt recalled feeling heartburn while resting which he described as strong urge to burp, but he was unable to do so.  It was reported that the pt described the sensation as a burning feeling in the middle of his chest and rated it as a 6 out of 10 on a pain scale.  On 10/03/03 the pt was seen in the ER where he was diagnosed with a MI.  The pt's medical records noted that he had experienced intermittent chest pain/pressure at rest for two to three weeks.  He had elevated cardicac enzymes, an initial EKG with ST elevation in Lead III, and subsequent T wave inversioni in leads II, III, and AVF.  See below for reported lab results.  The pt was hospitalized and underwent a cardiac catherization with stent placement.  Mild posterior wall hypokinesis was revealed.  The left heart catherization and left ventriculogram and coronary angiogram revealed severe two-vessel coronary artry disease with the right coronary artery being the culprit of the pt's recent non Q myocardial infarction.  The left anterior artery was of very small caliber.  It was not optimal for surgical intervention.  There was normal left ventricular systolic function.  Gated spect images of the heart were obtained after the pt's recovery, which revealed the left ventricular ejection fraction is calculated to be 66% and wall motion is good.  The impression from the Cardiolite scan was an abnormal perfusion study with ischemia in the inferolateral wall region.  The pt was discharged from the hospital and since his discharge he was denied any further chest pain or heartburn type symptoms.  The pt was schedule for another stress test on 11/15/03.  His recovery status is currently unknown.  It was also noted that the pt stated that he was concnered that the vaccinations he had received may have contributed to his cardiac problems.  MI was considered to be immediately life-threatening and an other important medical event (OMIC).  No further information is available.  This is an amended report.  This is a corrected report, as amended.  Information for this case was received through an enhanced surveillance program conducted by the CDC.  The VAERS # is 212869.  The AP manufacturer control # is 2003-03322. From additional information received ojn 30/Dec/2003 from manufacturer.... it was reported that lot number 5377AA does not correspond to this manufacturer product. Lot number 0980M does not correspond to VAQTA, manufacturer's hepatitis A vaccine. No other information was provided. No additional relevant information is provided for the adverse experience. This follow-up report is not submitted to the Health Authorities. From additional information received on 20/Jan/2004, the manufacturer report ID number was provided (WAES031USA02512). No other information was provided at this time.			Y	Y	Y	3			U	02/15/2003	10/03/2003	230	9/22/03 a radiologic examination revealed the lungs to be mildly hyperinflated, but clear of infiltrate. The heart and pulmonary vessels appeared to be nomal size. The impression was a non-specific hyperinflation and focal degenerative changes of the left distal clavicle of the AC joint. Gated spect images of the heart were obtained after hte pt's recovery, which revealed the left ventricular ejection fraction is calculated to be 66% and wall motion is good. The impression from the testing was abnormal myocardial perfusion study with ischemia in the inferolateral wall region.	MIL	MIL	Altace, Aspirin, Imdur, Lipitor, Lopressor, Plavix	NONE	Hyperlipidemia, DJD bilateral ankles, past history of migraines, which is now resolved. Denies any past of HTN, angina, CHF, CVA, valvular heart disease, diabetes, asthma, cancer, or thyroid disease. Surgical history includes left shoulder surgery.		200303322	1						2	Chest pain; Dyspepsia; Dyspnoea; Laboratory test abnormal; Myocardial infarction; Laboratory test abnormal; Myocardial infarction; Chest pain; Myocardial infarction; Chest pain; Dyspepsia; Laboratory test abnormal; Myocardial infarction; Myocardial ischaemia	ANTH~EMERGENT BIOSOLUTIONS~Unknown~2~SC~LA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~Unknown~3~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~5377AA~1~~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~0980M~1~IM~UN~HEP A (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~UB269AA~1~SC~UN~MENINGOCOCCAL (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4020071~2~ID~LA~SMALLPOX (DRYVAX)~1|YF~UNKNOWN MANUFACTURER~UB358AA~1~SC~UN~YELLOW FEVER (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~3~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|MEN~SANOFI PASTEUR~UB269AA~1~SC~~MENINGOCOCCAL (MENOMUNE)~2|SMALL~PFIZER\WYETH~4020071~2~ID~LA~SMALLPOX (DRYVAX)~2|YF~SANOFI PASTEUR~UB358AA~1~SC~~YELLOW FEVER (YF-VAX)~2|ANTH~EMERGENT BIOSOLUTIONS~~2~SC~LA~ANTHRAX (BIOTHRAX)~3|FLUX~UNKNOWN MANUFACTURER~~3~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|HEP~UNKNOWN MANUFACTURER~5377AA~1~IM~UN~HEP B (NO BRAND NAME)~3|HEPA~MERCK & CO. INC.~0980M~1~IM~~HEP A (VAQTA)~3|MEN~SANOFI PASTEUR~UB269AA~1~SC~~MENINGOCOCCAL (MENOMUNE)~3|SMALL~PFIZER\WYETH~4020071~2~ID~LA~SMALLPOX (DRYVAX)~3|YF~SANOFI PASTEUR~UB358AA~1~SC~~YELLOW FEVER (YF-VAX)~3|ANTH~EMERGENT BIOSOLUTIONS~~2~SC~~ANTHRAX (BIOTHRAX)~4|FLUX~UNKNOWN MANUFACTURER~~3~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~4|HEP~MERCK & CO. INC.~~1~IM~~HEP B (RECOMBIVAX HB)~4|HEPA~MERCK & CO. INC.~0980M~1~IM~~HEP A (VAQTA)~4|MEN~SANOFI PASTEUR~~1~IM~~MENINGOCOCCAL (MENOMUNE)~4|SMALL~PFIZER\WYETH~~2~SC~~SMALLPOX (DRYVAX)~4|YF~SANOFI PASTEUR~~1~SC~~YELLOW FEVER (YF-VAX)~4	USA	Life Threatening,Hospitalisation	Influenza
0214136	12/18/2003	PA	1.68	1	.7	F	12/02/2003	Pt discovered dead in bed with vomitus.  Autopsy reveal aspiration of formula.  Full autopsy report pending.  Pt was the product of a preterm 25 week gestation with a birth weight of 1lb 6oz.  Her neonatal course was prolonged and complicated by ligation of a patent ductus arteriosus, Broncopulmonary Dysplasia, Gastro-Esophageal Reflux Disorder, Retinopathy of Prematurity status post laser surgery, and a grade 4 intraventricular hemorrhage with severe developmental delay and cerebral palsy.  Neonatal hospitalization discharge date = 07/15/2002.  Her latest MRI showed a porencephalic cyst.  During her NICU course she also lost the tips of her left fingers 2,3,4 and 5 secondary to a PIC line complication.  Her developmental issues, constipation and poor weight gain were her most active problems.  Her weight gain had improved after starting supplemental Pediasure at 17 months of age.  She was seen in our office 11/24/03 for a weight check and incidentally found to have a upper respiratory tract infection and bilateral otitis media.  She was afebrile and nontoxic appearing with no wheezing or other adventitious chest sounds at that time.  For her otitis media she was prescribed Omnicef.  Because she looked well, she also received her second dose of influenza vaccine.  She had received her first dose of influenza vaccine on 10/23/2003 w/out incident or adverse reaction.	Y	11/29/2003							N	11/24/2003	11/29/2003	5	Autopsy-report pending, preliminary finding with aspiration	PVT	PUB	Zantac; Reglan; Miralax; Omnicef;	Otitis Media; Upper respiratory infection;				1						1	Aspiration; Vomiting	FLU3~SANOFI PASTEUR~U1088AA~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0214148	12/18/2003	MD	42.0	42		M		A report was received from a health care professional on 10/31/2003, concerning a 43 or 44 year old male vaccinee who was deaf 3 days after receiving Fluvirin on 10/24/03.  On 10/27/03, the vaccinee was completely deaf after receiving Fluvirin on 10/24/03.  The vaccinee has consulted with an ENT specialist and has further appointments scheduled with the specialist.  The reporter indicated that the vaccinee has experienced tinnitus for the past 5 years. The vaccinee is not taking any concomitant medications and has no known drug allergies.  The reporter indicated that the vaccinee has received the influenza vaccine each year for the past 5 years and experienced no hearing impairments.  This is the first year the vaccinee has received Fluvirin influenza vaccine.  There was insufficient information to determine the reporter's causality assessment.  Update: 12/05/03: Further information received from a health care professional indicated that the vaccinee was 42 years old and experienced sudden hearing loss in his right ear, which was disabling, 24 hours after receiving Fluvirin on 10/26/03.  The vaccinee had not recovered at the time of this report.  The reporter has assessed the relationship of the vaccine to the event as probable.  Follow up pending. The 15-day follow up received on 1/13/04 states further info received from a health care professional indicated that the vaccinee was still diabled and deafness was permanent on testing on two occasions. Follow up pending.								Y	U	10/26/2003	10/27/2003	1		UNK	UNK	NONE	NONE	Tinnitus for the past 5 years		PJP200300964	1						1	Deafness; Hearing impaired	FLU3~EVANS VACCINES~765707~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0214150	12/18/2003	WI	3.6	3		M	12/10/2003	Runny nose for a few days prior to the vaccine.				Y					Y	12/04/2003	12/05/2003	1	WBCL 14,300; 54 segmented neutrophils; 12 bands; 13 lymphs; Hemoglobin, platelets, electrolytes, BUN and creatinine were all normal.	PVT	PVT	NONE	Upper respiratory infection	NONE			1						1	Laboratory test abnormal; Rhinorrhoea; White blood cell count increased	FLU3~SANOFI PASTEUR~U1267AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214151	12/18/2003	NJ	11.0	11		F	12/17/2003	Local erythema, color,				Y					U	12/16/2003	12/17/2003	1	NONE	PVT	PVT	Singulair	NONE	Seasonal allergies			1						1	Erythema	FLU3~SANOFI PASTEUR~41088AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214152	12/18/2003	NC	0.6	0	.5	M	12/09/2003	Pt with (+) influenza (a) 1 week later.  (-) pt office visit. The medical record received on 12/29/03 states cough, fever and runny nose.				Y					U	12/03/2003				PVT	PUB	NONE	NONE	NONE		NC03143	1						1	Cough; Influenza; Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1088AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214153	12/18/2003	NY	5.0	5		F	12/16/2003	Flu vaccine administered on 12/11/03.  On 12/14/03 grandmother states the pt broke out in hives.  She was advised to administer Benadryl every 6 hours which seems to have helped with the hives.									Y	12/11/2003	12/14/2003	3	NONE	PUB	PVT	Pulmicort; Alximerol; Childrens Vitamins;	NONE	Asthma; Esotropiamanocula;			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1124AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214154	12/18/2003	CA	34.0	34		F	12/16/2003	Fever, shortness of breath, tight chest, about 20 minutes after vaccine.  Tx: breating tx's and cortisone shot.				Y					Y	12/10/2003	12/10/2003	0		OTH	OTH	NONE	NONE	NONE			1						1	Chest discomfort; Dyspnoea; Pyrexia	FLU3~SANOFI PASTEUR~U1142AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214155	12/18/2003	TX	10.0	10		F	12/10/2003	Varicella given SC approximately 10 min after injection, inflam and swelling appeared at site.  Child stated no problem, no palpatation, no breathing problem. Given Benadryl 12.5/5 10mL at 11:50.  Follow up with school nurse-inflam and swelling-no change at 11:30.  Update: 12/16/03, School nurse redness gone by 12/11/03, no further problems.									Y	12/10/2003	12/10/2003	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Injection site inflammation; Injection site oedema	FLU3~SANOFI PASTEUR~U1170AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~775A2~1~~RA~HEP A (HAVRIX)~1|PPV~MERCK & CO. INC.~0257N~1~~RA~PNEUMO (PNEUMOVAX)~1|VARCEL~MERCK & CO. INC.~1159M~1~SC~~VARICELLA (VARIVAX)~1	USA		Influenza
0214156	12/18/2003	CA	52.0	52		M	12/16/2003	Left upper deltoid/shoulder pain aggravated by raising left arm above shoulder level and behind head x 1 month.									U	11/19/2003	11/20/2003	1	Referral to clinic for further evaluation.	PUB	PUB	NONE	NONE	Left tendon rupture 3rd digit MCP doisal surface			1						1	Pain	FLU3~SANOFI PASTEUR~U1093AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214157	12/18/2003	NH	28.0	28		F	12/09/2003	W/in 24 hours after vaccines, I experienced heavy vomiting, diarrhea, lower body aches, hot flashes, cold chills.  Headache soreness in lower left calf muscle.  Loss of appetite.									Y	12/06/2003	12/07/2003	1	Almost 100% recovered	MIL	MIL	Tb Test (AP, C1262AA, ID, 2 previous doses)	NONE	NONE			1						1	Anorexia; Chills; Diarrhoea; Headache; Hot flush; Pain; Vomiting	FLU3~EVANS VACCINES~765412~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TYP~SANOFI PASTEUR~x0110~3~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0214158	12/18/2003	IN	48.0	48		F	12/15/2003	Developed a raised itchy rash all over my body prominent on hands, underside of arms, on thighs, hips, legs, top of feet.  The rash appeared day after shot and persisted for a week.  No other symptoms such as fever.  I felt fine otherwise.									Y	12/02/2003	12/03/2003	1	NONE	PUB	PVT	NONE	NONE	Cipro			1						1	Rash erythematous; Rash pruritic	FLU3~SANOFI PASTEUR~U1128AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214159	12/18/2003	ND	24.0	24		M	12/03/2003	A raised welt where the shot was given.  Very sore and itchy.									Y	11/13/2003	12/01/2003	18	NONE	PUB	MIL	NONE	NONE	NONE			1						1	Injection site pain; Injection site swelling; Pruritus; Urticaria	ANTH~EMERGENT BIOSOLUTIONS~FAV077~4~~~ANTHRAX (BIOTHRAX)~1|FLU3~EVANS VACCINES~765753~5~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214160	12/18/2003	NY	44.0	44		M	11/06/2003	Headaches, back pains, sweating, fever, stomach aches, coughing a lot, spitting up while salty spit.  Eyes hurting.  Fast heartbeat.  Diarrhea.  My side hurts feeling weak.				Y					U	11/17/2003	11/18/2003	1	Follow visited with doctor	PUB	PUB	Deprokote; Zoprezer; Cogentin; Norvac 5mg	Bipolar	High Blood Pressure			1						1	Abdominal pain upper; Back pain; Cough; Diarrhoea; Eye pain; Headache; Heart rate increased; Hemiparesis; Hyperhidrosis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0214211	12/18/2003	MS	2.0	2	.3	M	12/17/2003	Right arm between wrist and elbow, oval shape red raised one bump per mom.  Denies other problems. Instruted to call PMD if worsens or go to ER									Y	12/17/2003	12/17/2003	0	none	PUB	PUB	none	none	none		MS 03 102	1						1	Rash erythematous	FLU3~SANOFI PASTEUR~U1108AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214212	12/18/2003	CA	8.0	8		M	12/18/2003	Vomitting									Y	12/16/2003	12/18/2003	2		PUB	PVT						1						1	Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0214213	12/18/2003	FL	42.0	42		F	12/18/2003	Received vaccine 12/12/03.  On 12/15/03, woke with lymph node swelling over my collar bone and severe pain in shoulder.  Later that day it got to the point that I could not use my arm well.  The next day, 12/16/03, I went to the emergency room because of the pain and swelling.  The doctor treated it with a sling and pain medication and told me to follow-up if it does not resolve in 2 days.  The night of 12/17/03, I went to bed with chills.  On 12/18/03, at 1:00am I woke with severe pain in my shoulder.  I went back to the emergency room.  The doctor recommended that I remove the sling.  He gave me a prescription for doxycycline and some pain medicine.  I am still in a lot of pain, but will be starting the antibiotics today.				Y					N	12/12/2003	12/15/2003	3	# 13 does not allow me to enter the correct Manufacturer.  It is Aventis Pasteur	UNK	UNK	Xanax, Celebrex, Trazadone.	None	Congenital missing left kidney.			1						1	Chills; Lymphadenopathy; Shoulder pain	FLUX~UNKNOWN MANUFACTURER~41170AA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0214215	12/18/2003	AZ	69.0	69		F	11/19/2003	24 hours after flu vaccine shot, client states her L arm was very sore, increasing pain over next few days.  By 11/14, she noticed enlarged nodes, axillary L.  Yesterday (11/18) she noted enlarged, tender nodes under R arm (axillary area).  11/19 some soreness in neck - feels like she has fever and increased fatigue.  11/20 MD visit/diagnosis - sinusitis & breast problems - not from vaccine  MD advised mammo.				Y					U	11/06/2003	11/14/2003	8		PUB	PUB	None	No	birth defect - L hip: bone attached to hip <causing> hip to be rigid.  Lymph node <enlarged> from breast		AZ0314	1						1	Breast disorder female; Fatigue; Oedema; Pain; Pyrexia; Sinusitis	FLU3~SANOFI PASTEUR~U1122AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214216	12/18/2003	WA	0.3	0	.4	M	12/18/2003	none. The follow up received on 1/5/04 states child given flu vax inappropriately (under age)-no adverse reaction.									Y	12/11/2003			none	UNK	PVT	albuterol, ampicillin	cough	bronchiolitis, otitis			1						1	Drug administration error	FLU3~SANOFI PASTEUR~U1277AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214217	12/18/2003	NC	5.0	3		M	12/18/2003	Patient received 2nd dose of influenza vaccine on 12/08/03.  The next morning he woke up with a red itchy rash.  That day he went to the doctor and was diagnosed with hives.  Benadryl was used as the course of treatment.  The next day the red itchy rash was accompanied with swelling, particularly around the face and hands.  The hives lasted through 12/13/03.				Y					Y	12/08/2003	12/09/2003	1	A strep test was given on 12/09/03 to rule out strep throat.  The result was negative.	PVT	UNK		None				1						1	Erythema; Oedema; Rash pruritic; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0214200	12/19/2003	IA	48.0	48		F	12/18/2003	13:25: Pt in waiting room, came to counter and stated she didn't feel well.  Was very pale.  Stated having problems breathing.  13:26: Pt assisted to site down. MD notified immediately-crammed pt ordered Epipen auto inject O.3 mg given IM left thigh.  13:36: BP-156/120; 13:39: O2 @ 2L per made started per MD.  13:40 BP: 148/118, pulse oximetry 99% pulse 14.  13:50: Pt transported to ER by ambulance. The medical records received on 2/24/04 states dizziness and tight in throat.				Y					Y	12/17/2003	12/17/2003	0	NONE	PVT	PVT	NONE	NONE	Arthritis			1						1	Blood pressure increased; Dizziness; Dyspnoea; Heart rate decreased; Laryngospasm; Malaise	FLU3~EVANS VACCINES~766048~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214201	12/19/2003	MN	39.0	38		F	12/18/2003	Pt received flu shot in an outreach clinic on 11/21/03.  Within a few days she had pain in arm and difficulty in using right arm.  Unable to reach in closet.  Has pain day and night.  Not always consistant at time can do a motion and it's ok, but next time causes pain.									N	11/21/2003	11/23/2003	2	Pt called MD, trying Motrin and hot packs now for 2 weeks.	PUB	PUB	NONE	NONE	NONE			1						1	Hypokinesia; Pain	FLU3~EVANS VACCINES~765998~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214202	12/19/2003		6.0			F		Erythema and swelling left upper arm, pruritic per pt.  Area involved is from top of left arm to elbow.									U	12/08/2003	12/09/2003	1		OTH	OTH	UNK	UNK	UNK			1						1	Erythema; Oedema; Pruritus	FLU3~SANOFI PASTEUR~U1293AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214203	12/19/2003	KS	6.0	6		M		Red, diffuse, macular and urticarial all over body, slightly itchy, started day after injection.  Appointment on 11/20/03.  Gave Orapred 15mg/5ml 4 tsp every day.  Pt has fully recovered.									Y	11/13/2003			NONE	PVT	PVT	NONE	NONE	Allergies to Mold and Pollen			1						1	Erythema; Rash macular; Rash pruritic; Urticaria	FLU3~SANOFI PASTEUR~U1079AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214205	12/19/2003	VA	37.0	37		F	12/09/2003	All symptoms began within 12 hours of receiving vaccine: 1) 3 migraine headaches, pt has not had migraines in 20 years. 2) neck stiffness 3) numbness along right side of neck 4) throat constriction 5) temp 99.1 6) nausea.  Symptoms bothersome x2-3 days after vaccine.  Pt felt better about 11/24/03.  Pt had never received flu vaccine before.									Y	11/14/2003	11/14/2003	0	NONE	OTH	OTH	UNK	UNK	UNK			1						1	Hypoaesthesia; Migraine; Musculoskeletal stiffness; Nausea; Pyrexia; Throat tightness	FLU3~SANOFI PASTEUR~U1146CA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214206	12/19/2003	MO	34.0	34		M	12/09/2003	Awakened early AM, 12/08/03 with a irritating itchy rash covering 70% of body.  No difficulty breathing.  Rash persisted.  Reported by phone at 08:10.  Advised follow up at ER incase of anaphylaxis.  NP @ER could not determine conclusively that the reaction was caused by the vaccine.  Administered steroids IM and prescribed Hydroxyzine HCL 50mg and Prednisone 4mg, to be taken if reaction persists.				Y					Y	12/07/2003	12/08/2003	1	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Rash pruritic	FLU3~SANOFI PASTEUR~U1133AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214219	12/19/2003	CA	38.0	38		F	12/19/2003	Family had flu vaccination.  When mom had flu mist had bad reaction.  Sore throat and headache/fever.  Concerned that will give to children.  Does have fever. Cough. No trouble breathing.									Y	12/12/2003	12/13/2003	1		UNK	UNK		scratchy throat				1						1	Chest pain; Dyspnoea; Headache; Pyrexia; Throat tightness	FLUN3~MEDIMMUNE VACCINES, INC.~500032P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0214249	12/19/2003	AZ	48.0	48		F	12/19/2003	Patient noted generalized aches 12/16/2003 around 2 PM.  Temperature was 104.  She took Tylenol at 4 PM and midnight and again the morning of 12/17. Complaints of fever, dry cough, runny nose and dry throat. No headache, no respiratory distress.				Y					Y	12/16/2003	12/16/2003	0	None	PUB	PUB	None	None	None known			1						1	Cough; Dry throat; Pain; Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1142AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214252	12/19/2003	MD	27.0	27		F	12/19/2003	approximately 10 jminutes after receiving flu vaccine, experienced tingling sensation around mouth, metallic taste and a warm sensation that spread from mouth up through nose.  Given 10cc Benadryl PO (25 mg). BP 120/78       110/78 at 2:35 p.m.									Y	12/12/2003	12/12/2003	0		PUB	PUB	Orthotricyclen	None	None			1						1	Dysgeusia; Feeling hot; Paraesthesia	FLU3~EVANS VACCINES~765883~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214253	12/19/2003	MD	56.0	56		F	12/19/2003	Approximately 6 hours after receiving immunization developed horrible pain under left arm radiating to left shoulder, nect, and back of head.  Pain increases with movement.  Saw primary physician one day after receiving vaccine who diagnosed neuralgia secondary to influenza immunization.				Y					N	12/17/2003	12/17/2003	0		PUB	PUB		None	Diabetes			1						1	Neuralgia; Pain	FLU3~EVANS VACCINES~765883~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214256	12/19/2003	TX	46.0	46		F	12/19/2003	A couple hours after shot, small hives all over face, scalp, neck, some on arms. Some difficulty in breathing. Called family doctor the next morning and was told to take antihistamine which I have been taking since Tuesday.  Helps some but I still have the samll hives and some in difficulty breathing. Have had flu shots in the past and only reaction was a little nausea.									N	12/15/2003	12/15/2003	0	none at this time.	PUB	PUB	Remeron; Topamax; Zoloft; Prilosec; Tylenol Sinus and Allergy	None	Asthma; Activated Protein C Resistance; Rheumatoid Arthritis; Heart Arrythmia; White Matter Disease; Abnormal Blood Vessels (brain); Latex allergy;			1						1	Dyspnoea; Nausea; Urticaria	FLUX~UNKNOWN MANUFACTURER~05/06/03~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0214257	12/19/2003	PA	41.0	40		F	12/19/2003	102 degree fever, throat pain, watering eyes, headache									U	12/19/2003	12/20/2003	1		UNK	PVT		None				1						1	Headache; Lacrimation increased; Pharyngolaryngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0214258	12/20/2003	MA	42.0	42		F	12/20/2003	*runny nose/nasal congestion *no fever but mild case of the chills *tiredness, weakness, fatigue The live intranasal virus was administered on  12/12/03 at 8:30 a.m., and I was symptom-free until app. 8:30 a.m. of 12/16/03 when I lay down for a nap and slept for three hours. I needed to rest in bed for all of Tuesday and Wednesday. By Thursday, I could summon the energy to walk for two miles on my treadmill. By Friday, I felt well enough to go for a long walk and then see The Lord of the Rings with my family that night. in bed									Y	12/12/2003	12/16/2003	4		UNK	UNK						1						1	Asthenia; Chills; Fatigue; Nasal congestion; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~9/4/03~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0214229	12/22/2003		38.0	38		F	12/03/2003	Pt developed cellulitis to left arm injection site.  Area was red, hot and painful to touch.  Admitted to hospital and given IV antibiotics. The discharge summary received on 2/10/04 states swelling and volume depleted. The medical record received on 2/10/04 states difficulty moving, malaise, nausea, vomiting, and loose stools.				Y	Y				Y	10/31/2003	11/01/2003	1		MIL	OTH	UNK	UNK	Abdominal pain, lupus, miraine, fibromyalgia, endocarditis, allergy, rheumatic fever			1						1	Cellulitis; Diarrhoea; Injection site erythema; Injection site pain; Injection site reaction; Injection site warmth; Malaise; Movement disorder; Nausea; Oedema; Vomiting	FLU3~EVANS VACCINES~765141~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0214230	12/22/2003	NE	5.0	5		M	12/15/2003	Child ran a fever of 104.6 during the night after receiving the flu mist at noon on Thursday December 11.  Alternating Tylenol and Advil.  Temperature at 100.6 at time of this report.  Mother reported prior illness 1 week before with a temp of 104.8.  She also reported he had ran a temp of 100.7 the day before the vaccine was given.									Y	12/11/2003	12/11/2003	0	NONE	PUB	OTH	NONE	NONE	NONE			1						1	Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500034P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0214231	12/22/2003	WV	12.0	12		M	12/13/2003	Pt developed hives all over his body 10 hours after receiving the flu vaccine.  Hives associated with itching; relieved with over the counter Benadryl but receives when wears off.  Generalized mild erythematous rash; few are urticarial.  Pt given allegra 180mg every day for 10 days.				Y					Y	12/09/2003	12/10/2003	1	NONE	PUB	PVT	NONE	NONE	NONE			1						1	Erythema; Pruritus; Urticaria	FLU3~EVANS VACCINES~766052~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214232	12/22/2003	VA	31.0	31		F	12/17/2003	Client received flu vaccine on 12/09/2003 in left arm.  States flu shot given in back of arm, not muscular side part as is typical.  On 12/10/03, noted vax site was swollen and raised (larger than 1/2 dollar size); area hot to touch, tender.  No streaking noted.  Seen at ER on 12/11/03, told area infected.  Prescribed Keflex 500mg 4 times every 7 days.  Symptoms resolved 12/14/03.				Y					Y	12/09/2003	12/10/2003	1	NONE	OTH	OTH	Pre-Natal Vitamins	NONE	Allergy to Iodine; Pregnant EDD 05/20/2004.			1						1	Injection site oedema; Injection site swelling; Injection site warmth; Tenderness	FLU3~EVANS VACCINES~765971~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214233	12/22/2003	VA		23		F	12/17/2003	Client received flu vaccine on 12/09/03 in left arm. States shot given in back of arm-tricep area-not deltoid.  On 12/10/2003 noted vax site was tender with red, raised, hard area, hot to touch.  No drainage, no streaking.  Referred to ER.  Told area infected.  Prescription for antibiotic, but did not take.  Symptoms resolved by 12/15/03.				Y					Y	12/09/2003	12/10/2003	1	NONE	OTH	OTH	Ortho-Tricyclen	NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth	FLU3~EVANS VACCINES~765971~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214234	12/22/2003	AZ		3		M	12/12/2003	Identical twins in for office visit.  Both children have speech delays and answer to each other's names.  Worker from group home did not know the days either.  Pt received #3 flu .5cc shot one week apart fro #2 flu on 12/03/2003.  LPN, no incident to report.									Y	12/12/2003			NONE	PVT	PUB	NONE	NONE	UNK			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U1172AA~3~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214235	12/22/2003	PA	56.0	56		F	12/15/2003	Swelling/inflammation at site on injection measuring 4x3inches.									Y	12/12/2003	12/13/2003	1	Advised symptomatic treatment	PVT	PVT	NONE	NONE	NONE			1						1	Injection site inflammation; Injection site oedema	FLU3~SANOFI PASTEUR~U1148CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214236	12/22/2003	SD				M	12/09/2003	20 month old with large local reaction to site of influenza and prevnar vaccine site.									Y	12/02/2003	12/03/2003	1	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Injection site reaction	DTAP~SANOFI PASTEUR~U1007CA~4~IM~~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1098AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~1052M~3~IM~~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~494314~2~IM~~PNEUMO (PREVNAR)~1	USA		Influenza
0214237	12/22/2003	CO	45.0	45		M	12/19/2003	Low-frequency tinnitus-like the rambling of a distant train.  Onset Fall 2002 and resolved by late summer 2003.  Return of symptoms fall 2003 roughly same time as flu shot this year.  Mostly resolved now-but not 100%.									N	10/14/2002			More comments: most noticeable in quiet room or camping in wilderness.    (-) much worse, throbbing, when I had a cold 11/03.	PUB	OTH	NONE	NONE	NONE	sore arm~Hep B (no brand name)~3~40.00~In Patient		1						1	Tinnitus	FLU3~EVANS VACCINES~E35792KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~SANOFI PASTEUR~U1078AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214238	12/22/2003	WA	68.0	68		F	12/16/2003	Nausea and weakness after receiving shot-redness and swelling on neck.  12/08-noon.  Red, rash and swelling on shoulders, neck and arms 12/09.  Red, rash and swelling on stomach and legs.   12/10 dizzy, shortness of breath, nausea, choking 12/11: ER slept rest of 12/11, all of 12/12-12/13 very weak, just ate some and slept.  Weak and wobbly 12/14, 12/15, 12/16.				Y					Y	12/08/2003	12/08/2003	0	NONE	PUB	PVT	Verclan; Lipitor 10mg	NONE	Fluorescin Diagnosis; Codeine; PCN; Sulfa			1						1	Asthenia; Choking; Dizziness; Dyspnoea; Erythema; Nausea; Oedema; Rash	FLU3~SANOFI PASTEUR~U1143AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214239	12/22/2003	NJ	46.0	45		F	12/19/2003	Chills started at 20:00 and continued all night.  Arm sore for 2 days at site of vaccination.  4 days after felt wheezy and had mild cough that is still going on.  4 days after vaccination, rash on opposite site of left forearm and on right arm also had bumps that lasted 1 night.									N	12/08/2003	12/08/2003	0	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Cough; Rash; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0214336	12/22/2003	AL	7.0	7		F	12/22/2003	Pt said she felt dizzy and then passed out in the nurses office at school, landed flat on her face and had a possible seizure that lasted less than one minute.				Y					Y	12/09/2003	12/10/2003	1	tested positive for the flu on 12/10/03, was given tamiflu.	PVT	UNK	N/A	N/A	N/A			1						1	Convulsion; Dizziness; Laboratory test abnormal; Loss of consciousness	FLUX~UNKNOWN MANUFACTURER~765496~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0214337	12/22/2003	MN	2.0	2	.4	F	12/22/2003	rash covering right side of body has not cleared completely after three weeks still has spider veinlike appearance and colorless bumps.  Began as red/raw irritated and bumpy.				Y					N	12/05/2003	12/06/2003	1		PVT	UNK	none	none	none			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U1293AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0213835	12/23/2003	LA	41.0	40		F	12/23/2003	Started with pneumonia in Nov., 1st to be exact, 3 weeks later got pneumonia vac., that's when everything happend and went downhill for me. Arm swelled up to 5 inches in diameter, was rushed to ER 3 times, seen Allergist, blood Dr. and many others, still unknown as to why arm hurts .  MRI was done, confirmed swelling of inflamation of muscle tissues.  EXTREME pain in arm where vac. was given, large, rock hard lump just under skin.  Vac. was given 2 months ago, I am still in alot of pain, can get no answers or help.  Was given 3 doses of steriods, body had swelled almost overnight, so extreme, body started to bruise, they thought the steriods would help, but they did not.  Blood count revealed elevated white blood cells, so they said infection, was hospitalized for a week with IV antibiotics, came home with anitbiotics for 2 more weeks.  My mobility in arm is very limited and almost non functional.  I need help, and answers, I went for a vaccination, not a disability.  To this date, I am still in pain with the arm, hardly any mobility with the arm, and cannot work until I have my arm working again, PLEASE help if you have any answers. 60-day follow up on 03/22/04: Pt did not recover from adverse events. Arm is still in pain, very little movement can be made without any pain.  Nurse follow up on 07/21/04 states: abdominal pain.				Y	Y	7			N	11/17/2003	11/18/2003	1	elevated white blood cells, swelling of muscle tissue, inflammation; LFT elevated; Lab values abn; Medical records state ERS increased, SGOT, SGPT increased. msv	UNK	UNK	Lexpro	pnemonia	allergic to dust and mold; Thyroid cyst; Depression;			1						2	Injection site pain; Injection site swelling; Lymphadenopathy; Oedema; Pain; Abdominal pain; Alanine aminotransferase increased; Aspartate aminotransferase increased; Contusion; Hepatic steatosis; Hypokinesia; Infection; Injection site mass; Injection site oedema; Injection site pain; Laboratory test abnormal; Myopathy; Red blood cell sedimentation rate increased; White blood cell count increased	PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~unknown~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0214261	12/23/2003	IL	1.0	1	.0	F	12/15/2003	Pt developed eczema herpeticum below left eye.  Spread to face.  Hospitalized for 48 hours.  Recovered on acyclovir. Fever, eyes: itching, sore. Ear pain, swollen glands and swollen cracked lips.  Pt is a 12 month old female sent by a dermatologist for diagnosis of eczema herpeticum.  Pt's mother states pt had runny nose, cough and fever for 6 days, developed a single lesion that looked red-based and fluid filled on 12/07.  On 12/10 pt was seen by PMD for fever and swollen glands and was diagnosed with a tear duct infection.  On (12/11), child awoke with swollen, cracked and bleeding lips.  Child soon developed 1-2 blisters around lips. Mom states that more lesions appeared in a short period of time both around mouth and left eye but has been stable since the lesions developed earlier today.  Mom has also noticed the pt rubbing her eyes and stated that the child was screaming and crying more than usual last night.  Cough and rhinorrhea have improved per mom, and fevers have been controlled with Motrin whenever mom thought the child was febrile to touch. Mom has never noticed dry skin or other skin problems on child. Pt received influenza and varicella vaccines 2 weeks ago and notes that one of her friends also has a child who received a varicella vaccine and then developed a perioral and periorbital lesion.  The children played together on 12/06 after the friend had developed the lesions; pt developed cough/fever on 12/07 and first lesions on the 12/08.  Pt was given IV acyclovir along with ancef and started getting better.  Viral PCR came back positive for HSV 1. Nurse follow up on 05/18/04 states: Unable to walk, paresthesias, urinary retention.  Remove:anuria.					Y	2			Y	12/01/2003	12/06/2003	5	BP: 138/76; Pulse: 177; Temp: 98.8; Resp: 40; CBC w/diff: pending; Complete Metabolic panel: pending; Culture and Gram stain of lesion: pending; HSV DNA detection from lip: pending;	PVT	PVT	PPD-AP-Lot #: C1616AA/ID	NONE	NONE			1						1	Abasia; Blister; Cough; Dry skin; Ear pain; Eye pain; Face oedema; Herpes simplex; Infection; Oedema; Paraesthesia; Pruritus; Pyrexia; Rhinorrhoea; Screaming; Urinary retention; Viral infection	FLU3~SANOFI PASTEUR~U1094AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~495024~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0577N~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0214262	12/23/2003	MO	28.0	28		M		Progressive weakness of lower extremities probable demyelinating syndrome post respiratory infection.  12/06/03 inability to urinate or past vaccination.					Y				U	11/19/2003	12/06/2003	17	Abnormal CSF; positive cytomeglovirus	OTH	OTH						1						1	Anuria; Asthenia; CSF test abnormal; Demyelination; Hepatocellular damage; Infection	FLU3~SANOFI PASTEUR~U1254AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0214263	12/23/2003	TX	55.0	54		M	12/18/2003	Hearing loss right ear 12/4/03 7pm. Vertigo and nausea 12/5/03 2am. Hospitalized 12/5 to 12/8/03. Hearing loss, vertigo remain. The medical record received on 2/17/04 states tinnitus, and beating nystagmus. Permanent hearing loss one ear. Persistent vertigo. Per annual report- permanent hearing loss (deafness) in one ear and residual vertigo. Discharge summary sttes viral infection. msv				Y	Y	4		Y	N	11/19/2003	12/04/2003	15	MRI neg for masses on signs of stroke Discharge summary states hyperglycemia. msv	OTH	PVT	NONE	NONE	benign prostatic hypertrophy			1						1	Deafness; Hearing impaired; Hyperglycaemia; Nausea; Nystagmus; Tinnitus; Vertigo; Viral infection	FLU3~EVANS VACCINES~765409~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0214264	12/23/2003	MA	11.0	10		M	10/18/2003	Flumist given at 6:46pm appr. 20 mins after receiving vaccine pt had complaints of blotchy redness on back of neck and complaints of throat swelling. Assessed by Dr and 2 tsp of Benadryl given. No difficulty breathing. Assessed every 5 minutes until 7:35. No symptoms at this time.  Follow up on 10/13/04 states: information obtained from the reporter indicated that <20 minutes after FluMist pt had hive-like rash in neck (4-5 reddish spots 2cms in diameter), itching in neck, plus sensation of throat swelling which lasted for approximately 45 minutes. Pulse was 96/min, O2 saturation 99%. Given Benadryl 2 tsp's (presentation 12.5mgs/5ml) 5 min after symptoms onset. The only history of allergy was dermatitis after poison ivy.									Y	10/16/2003	10/16/2003	0		PVT	PVT		NONE	Contact dermatitis due to plants			1						1	Erythema; Heart rate increased; Laryngeal oedema; Oedema; Pruritus; Rash macular; Throat tightness; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500032P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0214265	12/23/2003	OH	10.0	10		M	12/16/2003	Abdominal cramping, vomiting, and later diarrhea for approx 1 week. After receiving the flu-mist. Pt states he felt it run down the back of his throat and he swallowed some. Follow up: Seen on 12/15/03, abd soft/ increased bowel sounds.  Had complained he could taste the Flumist for a week in his throat.				Y					Y	12/09/2003	12/10/2003	1	NONE	PVT	PVT		NONE	Allergy to PCN			1						1	Abdominal pain; Diarrhoea; Dysgeusia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500001P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0214266	12/23/2003	AK	49.0	49		F	12/09/2003	Reported feeling funny and uncoordianted immediately following administration of vaccines. Reported feeling worse 12/5/03 with fever. Eyes began to swell 12/5/03. By 12/7/03 eyes were swollen bad pt couldn't open or close them. Reported feeling better today-no fever. Still fees uncoordinated and eyes are still a little puffy. Reports vomiting, coughing and sore throat on 12/7/03.									U	12/04/2003	12/04/2003	0		PUB	PUB	Phenobarbital		Lupus, seizure disorder, allergic to Zanaflex		AK200356	1						1	Coordination abnormal; Cough; Eye oedema; Feeling abnormal; Pharyngolaryngeal pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1141AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0523AA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0214267	12/23/2003	AK	26.0	26		F	12/12/2003	12/4/03 (4am) sore muscles, rapid pulse with irregular beat then fell back asleep until 130pm woke with fast pulse (100bpm) but no irregular beat currently 4pm (108bpm).									Y	12/03/2003	12/04/2003	1		PUB	PUB	NONE	NONE	NONE		AK200351	1						1	Heart rate increased; Heart rate irregular; Myalgia	FLU3~SANOFI PASTEUR~U1141AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214268	12/23/2003	AK	34.0	34		F	12/08/2003	Had flu shot on 12/5/03 she reports 5-10 mins post injection she felt dizzy but didn't say anything. 6 hrs later she started having rash on her face and itching which spread all over her body. She also reports some tightness on her chest. Seen client on 12/8/03 noted hives on her chest neck and her legs not much on her face also c/o of itching. Benadryl 25mg give q 4-6 hrs. Denies resp. distress at this time.									Y	12/05/2003	12/05/2003	0	NONE	PUB	PUB	Motrin prn for pain	NONE	Detrocordia; c-section delivery 11/13/03, allergy to latex-itching		AK200352	1						1	Chest discomfort; Dizziness; Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U1141AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214269	12/23/2003	AK	6.0	6		F	12/12/2003	Mom reports intensely itchy patches of 3-4 bumps each approx 4 patches. NO other s/s illness. No known allergies. PHN rec. TC to MD-mom until 20 Hctz oint prn-has Benadryl at home.									U	12/10/2003	12/11/2003	1		PUB	PUB	UNK	UNK	UNK		AK200354	1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U1141AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214270	12/23/2003	MI	50.0	50		F	11/12/2003	10/9/03 client states shoulder areas were sore post flu shot and just never got better. 10/21/03 seen by a family doctor for continued shoulder pain. See attached notes Dr does not feel this is related to the flu vaccine client has rheumatoid arthritis.									N	10/09/2003	10/09/2003	0	Sed rate, CRP, ANA	PUB	PUB	Seroquel, Aspirin, Motrin	NONE	Schizophrenia, 12 yr old injury to rotator cuff, arthritis shoulder, rheumatoid arthritis		MI2003062	1						1	Myalgia; Shoulder pain	FLU3~EVANS VACCINES~765196~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214271	12/23/2003	IN	49.0	48		F	12/19/2003	Day 1: Muscle aches, fatigue that persisted through 5 days after vaccination.  Day 6: Recipient awoke to aching joints localized to right arm with swelling and redness at right wrist and a burning sensation to the inner aspect of the right elbow.  Currently improved.				Y					Y	12/08/2003	12/08/2003	0	Testing will take place on 12/20/2003: Basic Metabolic panel, CPK, AST, TSH and Glycohemoglobin	OTH	PVT	Niastatin; Lotril; Glucophage; Lasix; Lopressor; Zocor; Aspirin	NONE	Chronic Artery Disorder; Diabetes; Allergies: PCN, Iodine, Shellfish			1						1	Arthralgia; Erythema; Fatigue; Myalgia; Oedema; Skin burning sensation	FLU3~SANOFI PASTEUR~U1126AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214272	12/23/2003	FL	42.0	42		F	12/11/2003	At 2:30pm: at the doctor's office he told her blood pressure and it was 138/90 got lightheaded, and dizzy, flushed. Was brought in to the room, took another BP 160/100, pulse 120. Swelling at injection site, 4 all around at 3pm started to have chest tightness, SOB, EMS was called. BP still at 100/60, P=100, Benadryl was administered, taken to hospital ER, EKG and CXR done, and lab works. Released at around 7:30 or 8pm.				Y					Y	12/10/2003	12/10/2003	0	EKG and CXR done, and lab works.	PUB	PUB	Wellbutrin, Glucophage, Lipitor, INH, Gluestral, Lantus, Celebrex	NONE	Diabetes, back injury, PCN, epi			1						1	Blood pressure increased; Chest discomfort; Dizziness; Dyspnoea; Flushing; Heart rate increased; Hypersensitivity; Injection site oedema	FLU3~EVANS VACCINES~766043~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214273	12/23/2003	TX	2.0	2	.4	F	12/16/2003	Fever, red, swollen thigh around injection site day after injection of pneumovax.  Told lukewarm compresses and Motrin as needed for pain.  Unable to walk 1 day.									Y	11/10/2003	11/11/2003	1	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Difficulty in walking; Injection site erythema; Injection site oedema; Pyrexia	FLU3~SANOFI PASTEUR~U1092AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0257N~1~~RL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0214274	12/23/2003	TX	11.0	11		M	12/16/2003	Pt had soreness in the injection site day after injection.  No swelling, no redness.									Y	11/03/2003	11/04/2003	1	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U1092AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214275	12/23/2003	TX	16.0	16		M	12/16/2003	Fluzone given on 11/03/2003.  On 11/05/2003 developed. Tired, pain at joints, runny nose, mild fever.									Y	11/03/2003	11/04/2003	1	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Arthralgia; Fatigue; Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1042AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214276	12/23/2003	TX	11.0	11		M	11/13/2003	Pt's left arm was swollen with a large bump at the injection site and hurts to touch.  Pt had full range of motion of left arm. Luke warm compresses and Motrin as needed for pain.									Y	10/21/2003	10/28/2003	7	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Injection site mass; Injection site pain; Oedema	FLU3~SANOFI PASTEUR~U1092AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0257N~1~~LA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U0527AA~1~~RA~TD ADSORBED (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~0335N~1~~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0214277	12/23/2003	TX	11.0	11		M	12/16/2003	Pneumovax 23 was given 10/31/2003 on 11/01-11/02.  Pt developed redness and swelling with pan and fever at site of vaccine injection.  Symptoms improved with warm compresses.									Y	10/31/2003	11/12/2003	12	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1092AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0257N~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0214278	12/23/2003	TX	11.0	11		M	12/16/2003	Right arm and under site into armpit was very sore and red.  Luke warm compresses 2-3 times a day and Motrin for pain as prescribed.									Y	11/10/2003	11/12/2003	2	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Erythema; Pain	FLU3~SANOFI PASTEUR~U1092AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0257N~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0214279	12/23/2003	PA	71.0	71		M	12/17/2003	Pt developed swelling, redness of arm from site of injection to his fingertips almost immediately after the shot.  Pt also reports the shot being painful upon injection.									Y	11/14/2003	11/14/2003	0	NONE	PVT	PVT	Atenolol; Synthroid; Norvasc; Aspirin; Zantac;	NONE	Allergic to shrimp, iodine, pcn, and sulfa.  Coronary artery disease, hypothyroidism, hyperlipidemia, hypertension, gastritis.			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U1146KA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214280	12/23/2003	ME	6.0	6		F	12/15/2003	12/14/2003: Red lump size of 1/2 dollar, swollen, warm to touch, no itch, no fever, no red streaking.									U	12/12/2003	12/14/2003	2	12/15/03: Not as big still red and swollen	PVT	OTH	NONE	NONE	NONE	swelling in arm~DTaP (no brand name)~5~4.00~In Patient		1						1	Injection site erythema; Injection site mass; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U1148EA~3~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214281	12/23/2003	MT	77.0	77		F	11/12/2003	Received flu shot in left arm on 10/23/03.  Noticed on 11/12/03 arm was sore, dime sized red spot, tissue more firm.									Y	10/23/2003	11/12/2003	20	NONE	PVT	OTH	Trimephoprim 100mg 3 times a day; Lipitor, MVI	HEALTHY	NONE			1						1	Erythema; Injection site induration; Pain	FLU3~SANOFI PASTEUR~U1122AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214282	12/23/2003	MI	12.0	12		F	12/09/2003	4 vesicles in diff phases, 2 scabbed over and 2 vesicular with clear fluid, itchy too.									U	11/20/2003	12/08/2003	18		PVT	PVT	NONE	NONE	NONE			1						1	Blister; Pruritus	FLU3~SANOFI PASTEUR~U1287AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0572M~1~IM~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0214283	12/23/2003	CA	7.0	13		M	12/12/2003	Large red, painful area at deltoid, about 4x6cm at left, site of Pneumovax.  Prescribed Diprolene cream and Tylenol per mouth.									U	12/08/2003	12/10/2003	2	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Injection site erythema; Injection site pain	FLU3~EVANS VACCINES~765139~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0947N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0214284	12/23/2003	FL	60.0	60		F	12/14/2003	I received both the flu shot and the pneumonia shot on the same day.  Pneumonia shot in left arm.  Flu shot in right arm. Left arm became swollen with severe pain from shoulder to elbow.  I was nauseous and dizzy.  Next day a little better.  3rd a little better etc.  Took some Tylenol.									Y	12/08/2003	12/08/2003	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Dizziness; Injection site oedema; Injection site pain; Nausea	FLU3~PFIZER\WYETH~765749~1~~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|PPV~MERCK & CO. INC.~1196M~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0214285	12/23/2003	OH	49.0	49		F	12/15/2003	On 10/09 back broke out in slight rash by 10th early evening, back and neck were completely broken out and itching.  Were on cruise ship MD's office was closed.  So went as soon as opened next day, treated hives.				Y					Y	10/08/2003	10/09/2003	1	NONE	OTH	OTH	Vasotec	NONE	Hypertension;			1						1	Pruritus; Rash; Urticaria	FLU3~EVANS VACCINES~765499~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214287	12/23/2003	NC	50.0	50		F	12/16/2003	Soreness and warmness of arm.  Chills and febrile x2 days.									Y	12/10/2003	12/12/2003	2	NONE	PUB	PUB	NONE	NONE	NONE		NC03144	1						1	Chills; Feeling hot; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1129AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0864N~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0214317	12/23/2003	CA	1.3	1	.2	M	12/12/2003	Received flu vaccine and 15 month immunizations 12/09/2003 at 13:00.  Noted increased swelling to right thigh.  Swelling below right knee to upper thigh.  Bruising at one injection site noted.  Treatment: Ice, hist.									Y	12/09/2003	12/09/2003	0	NONE	PVT	UNK	NONE	Mild nasal congestion	NONE			1						1	Contusion; Injection site oedema	DTAP~GLAXOSMITHKLINE BIOLOGICALS~592B9~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1170AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~UA873AA~4~IM~RL~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0214330	12/23/2003	NY	57.0	57		F	12/22/2003	Knelt down approximately 8hours after receiving vaccine to pet my dog, felt dizzy and strange, stood up and heart was beating fast. Episode passed.									Y	12/19/2003	12/19/2003	0	NONE	PUB	PVT	Busperone 5mg	NONE	Chronic lymphocytic leukemia			1						1	Dizziness; Heart rate increased	FLU3~EVANS VACCINES~766051~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214331	12/23/2003	NJ	1.4	1	.4	F	12/15/2003	09:25: Toddler developed hives starting around injection site, progressing to shoulder and back.  To ER, hives developed on legs.  No breathing difficulties in clinic or ER. Given Benadryl and steroid shot states mom. Recommended Benadryl Elixir for 2 days if needed follow up with ER physician.  Telephone call 12/15/03, no further hives.				Y					Y	12/12/2003	12/12/2003	0	NONE	PUB	PUB	NONE	NONE	NONE		NJ200331	1						1	Urticaria	FLU3~SANOFI PASTEUR~U1075AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214413	12/23/2003	NJ	4.0	4		F	12/23/2003	She was RER. She did not receive cranial XRT. Our working diagnosis is diffuse, patchy neuritis with ascending myelitis probably due to intrathecal MTX vs. vincristine peripheral neuropathy vs. Guillian-Barre secondary to the influenza vaccine vs. CNS relapse. We can send viral titers—which ones would you recommend? CMV, EBV?   We have an adverse event in a 4 year old Hispanic female with high risk ALL (secondary to initial WBC of 50.2 /ul at diagnosis)  being treated in the maintenance phase of CCG 1961.  On 12/1/03, JP received IT MTX and VCR IVP (bili 0.3 that day) without problem. She was also given an influenza vaccine IM.  On 12/8/03, she presented to clinic with complaints of irritability, dysuria, constipation, and a low grade fever—cultures were obtained and patient was given empiric therapy with Ceftriaxone. UA/UC and blood culture were negative.  Father called again on 12/11/03 to say that patient was not walking well and she had been incontinent of urine—these symptoms started 12/10/03. She was seen in the office the day the father called and her gait was very ataxic with foot drop. DTR in LE were +1-+2 and symmetric. There was no clonus. Father reported that she had been incontinent of urine and stool. He believed that she was incontinent of loose stool due to the Miralax given 12/8/03. We questioned whether this was due to a vincristine peripheral neuropathy vs. Guillian-Barre. JP was referred to Neurology who saw her that afternoon and requested a CK and MRI of the spine with and without Gadolinium. The CK was drawn on 12/12/03 and was normal. Neurology scheduled her MRI for 12/17/03. The father did not call to report any worsening of symptoms until 2 am today (12/17/03) when he called to say that her abdomen was distended and she was compalining of abdominal pain. He also reported that she was not walking at all and that he had been carrying her everywhere since 12/14/03. She came to the emergency room and her PE was remarkable for paraplegia, inability to sit up, and decreased strength in her upper extremities. She has no respiratory issues. JP was catheterized for 500cc of urine. Her MRI shows no compression and she has diffuse, but patchy neuritis with ascending myelitis. She is in the PICU for observation of her respiratory status and was started on Decadron 4 mg IV q 6 hrs after a BMA and LP were performed. Her CSF shows 4 WBC, 14 RBC and gram stain is negative. CSF glucose is 56 mg/dl. Right now all of her chemotherapy is on hold. Do you have any further suggestions regarding her management at this point? Are there any medications that could be used as a rescue? We really appreciate your input.			Y						U	12/01/2003	12/17/2003	16	Please see attached letter above.	PVT	UNK	Vincristine IT MTX	ALL	None			1						1	Abdominal pain; Asthenia; Constipation; Coordination abnormal; Difficulty in walking; Faecal incontinence; Gait disturbance; Guillain-Barre syndrome; Laboratory test abnormal; Myelitis; Neuritis; Neuropathy peripheral; Paraplegia; Peroneal nerve palsy; Pyrexia; Urinary incontinence	FLU3~EVANS VACCINES~765499~1~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening	Influenza
0214415	12/23/2003	GA	33.0	32		F	12/23/2003	One week after vaccinations, patient had very severe headache, stiff neck, and low grade fever (less than 100F).				Y					N	12/15/2003	12/22/2003	7	Blood and CSF will be sent to CDC-Ft.	UNK	UNK	Allieve, Immitrex prn, Diuretic prn, antibiotic for UTI	UTI	History of migraine headaches			1						1	Headache; Musculoskeletal stiffness; Pyrexia	DT~SANOFI PASTEUR~UI000AA~UNK~IM~LA~DT ADSORBED (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~RA~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~RA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~XD146~UNK~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MEN~SANOFI PASTEUR~UB493AA~UNK~SC~RA~MENINGOCOCCAL (MENOMUNE)~1|YF~SANOFI PASTEUR~UB492AA~1~SC~LA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0214416	12/23/2003	MO	9.0	9		M	12/18/2003	Mother called to report child developed cruddy sounding cough for 2-3 days after administration.  Child told mother he wanted to cough right after administration but couldn't cough and throat felt funny.									Y	12/12/2003	12/12/2003	0		UNK	UNK					MO2003108	1						1	Cough	FLUN3~MEDIMMUNE VACCINES, INC.~500003P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0214417	12/23/2003	FL	6.0	6		M	12/23/2003	Healthy and asymptomatic prior to vaccination.  Vaccinated with Flu-Mist On 12/19/03.  On 12/20/03 developed couph,  & chest tightness' On 12/21/03 Cough worsened (croupy) and Fever to 103F reported. Temp. reported to have reached 105.5 on 12/22/03 ( report by mother). Seen by Dr. and put on Antibiotic 12/22/03. Temp. coming down today and child somewhat better today per mother. Medical records state rhinitis, epistaxis and ear pain. msv				Y					Y	12/19/2003	12/20/2003	1	None done	UNK	UNK	N/A	NONE	NONE			1						1	Chest discomfort; Cough; Ear pain; Epistaxis; Pyrexia; Rhinitis	FLUN3~MEDIMMUNE VACCINES, INC.~50047P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0214418	12/23/2003	WI	18.0	18		F	12/23/2003	The patient presented at the clinic on 12/19 with complaints of headache, nausea, neck ache, mild left arm numbness and fever.  Was diagnosed with a viral syndrome and sent home with symptomatic management.  She then presented to the ER on 12/20 with a left-sided hemiparesis and mental status changes.  She was admitted and started on antibiotics as well as acyclovir.  She was subsequently started on steroids after an MRI showed findings that suggested acute disseminated encephalomyelitis (ADEM).  During the course of the day on 12/20, the patient's status deteriorated as she developed unequal pupils and later required intubation for compromised respiratory status.  She then was put on an esmolol drip for tachycardia, but that was stopped when pt became hypotensive on the morning of 12/21.  She was then started on dopamine.  During this time course, her neurologic status also declined, and on the morning of 12/21, her pupils were fixed and dilated, and patient presented evidence of brain death with no spontaneous respirations and negative cold calorics. Brain death was pronounced on 12/22 after repeat evaluation, and life support was withdrawn. Medical Record received on 1/08/2004 states chills.	Y	12/22/2003							N	12/11/2003	12/19/2003	8	Lumbar puncture w/ cerebrospinal fluid cultures, which were negative.  Herpes PCR pending. Blood cultures negative. Serial CT scans- cerebral edema w/ a mid-line shift and effacement of the sulci and compression of the 4th ventricle MRI- white matter changes suggestive of acute disseminated encephalomyelitis	UNK	UNK	None	None	No allergies History of meningococcemia at age 2, which required multiple skin grafts and bilateral knee and hip replacements. History of cervical dysplasia			1						1	Chills; Congenital brain damage; Encephalitis; Headache; Hemiparesis; Hypoaesthesia; Hypotension; Laboratory test abnormal; Mental impairment; Mydriasis; Nausea; Pain; Paralysis; Pyrexia; Tachycardia; Viral infection	FLU3~EVANS VACCINES~765880~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~MERCK & CO. INC.~1497L~2~IM~RA~HEP B (RECOMBIVAX HB)~1	USA	Results in Death	Influenza
0214419	12/23/2003	IL	40.0	40		M	12/23/2003	PATIENT REPORTS THAT HE DEVELOPED CERVICAL ADENOPATHY WITHIN 24-48 HOURS FOLLOWING RECEIVING ANTHRAX#1. LYMPHADENOPATHY CONTINUED FOR SEVERAL MONTHS.				Y					Y	02/13/2003	02/15/2003	2	PPD ON OCTOBER 5,2003 WAS NEGATIVE	MIL	MIL	NONE	NONE	NONE			1						1	Lymphadenopathy	ANTH~EMERGENT BIOSOLUTIONS~FAV066~1~SC~UN~ANTHRAX (BIOTHRAX)~1|FLU3~PFIZER\WYETH~UO674AA~5~IM~UN~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0214339	12/24/2003	VA	43.0	42		M	12/16/2003	MI-required stent			Y		Y	3			Y	12/11/2003	12/13/2003	2	Cardiac cath-100% occular right main	PVT	PVT	Depakote; Dextrostat;	Attention Deficit Disorder	History of Hypercholesterimia-off lipitor 5 months.			1						1	Myocardial infarction	FLUN3~MEDIMMUNE VACCINES, INC.~500016N~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Life Threatening,Hospitalisation	Influenza
0214348	12/24/2003	IN	0.9	0	1	M	12/13/2003	Child received 1/2 dose of flu shot on 12/11/03. On 12/12/03 he was brought to hospital ED in status epilepticus. This child has no history of seizure disorder or febrile seizure. The morning of SZ, child had a fever of 101 deg. The ER records received on 1/28/04 states crying, jerking, and vomiting. The discharge summary received on 1/28/04 states limp and right sided shaking. Nurse follow up on 05/18/04 states: Seizure:Convulsion.				Y	Y	1			Y	12/11/2003	12/12/2003	1	Head CT (-); lumbar puncture (-)	PVT	PUB	Albuterol nebulizer prn	Upper respiratory infection, no fever at time of vaccination.	RSV bronchiolitis (11/7/03), rxn to Augmentin (vomiting), Ear infection, cough, runny nose.			1						1	Agitation; Convulsion; Dyskinesia; Hypotonia; Pyrexia; Status epilepticus; Tremor; Vomiting	FLU3~SANOFI PASTEUR~U1106AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0214349	12/24/2003	MO	56.0	56		F	12/07/2003	Flu symptoms within hours of of vaccine. Two days in bed. 10/30 ER-couldn't breathe. Sent home. ER again 11/1. Admitted. Discharged 11/7. I was sick. Discharge Summary received on 12/31/2003 states anxiety, bronchitis and exacerbation of COPD.				Y	Y	6			Y	10/21/2003	10/21/2003	0		PVT	PVT	Advair; Combivent	Sinus Infection	COPD			1						1	Anxiety; Bronchitis; Condition aggravated; Dyspnoea; Influenza like illness	FLU3~EVANS VACCINES~765502~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0214350	12/24/2003	MA	20.0	19		M	12/28/2003	Guillain Barre syndrome. Hospitalized at hospital. Still no reflexes in ankles and knees bilaterally. Discharge summary states paresthesia, pain. msv Medical records state myasthenia, accidental injury. msv					Y				N	11/15/2003	12/17/2003	32	Discharge summary states CSF abnormal. msv Medical records state lab test abnormal. msv	PVT	OTH		NONE	Asthma, OCD Medical records sttes abnormal thinking as pre-existing problem. msv			1						1	CSF test abnormal; Guillain-Barre syndrome; Hyporeflexia; Injury; Laboratory test abnormal; Myasthenic syndrome; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U1139AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0214352	12/24/2003	TN	66.0	66		M	12/10/2003	Today client complained of feeling of tiredness on left arm and lack of strength to life objects, minimal weight.  Client states only mild local reaction following injection.				Y					U	10/30/2003	11/13/2003	14	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Asthenia; Fatigue; Injection site reaction	FLU3~EVANS VACCINES~765753~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~SANOFI PASTEUR~40833AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0214353	12/24/2003	CA	53.0			F	12/23/2003	Pt had flu shot. About 1 week later (11/08/03) pt noticed excessive tearing left eye, assymmetrical facial weakness, change in sense of taste when chewing.  Pt was seen by MD on 11/10/03. MD noted peripheral weakness of CNVII, weakness left upper eyelid, facial asymmetry. A neurologist was consulted and diagnosed Bells'Palsy prescribed Acyclovir 500mg 5 times a day for 10 days and Prednisone taper.  On 11/11, pt noticed blurred vision, headache, blackspot in left visual field.  On 11/19/2003 pt reported vertigo x2 and dizziness. Medical record states ptosis. msv				Y					U		11/08/2003		symptoms improving, as of 11/19/03, but still hard to close eyes, some secretion.  MRI of brain 12/10/03: No c/o mass	PVT	PVT	NONE	Left subconjuctival hemorrhage	Chronic Hepatitis B carrier, Hyperlipidemia			1						1	Dizziness; Dysgeusia; Eyelid ptosis; Facial palsy; Headache; Lacrimal disorder; Vertigo; Vision blurred; Visual disturbance	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214354	12/24/2003	CA	54.0	54		F	12/23/2003	Approximately 5-6 hrs after receiving flu vaccine,  consumer reports that she was very diaphoric general weakness and strained breathing.  Individual states self-improsed bedrest for two hours.  symptoms relieved after 2 hours.									Y	11/22/2003	11/22/2003	0	NONE	OTH	PVT	NONE	NONE	Had anaphylactic reaction to bee sting as a child			1						1	Asthenia; Dyspnoea; Hyperhidrosis	FLU3~EVANS VACCINES~765668~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214355	12/24/2003	OH	1.5	1	.8	M	12/17/2003	Pt had 2-3 weeks of extreme fussiness after receiving his influenza vaccine.									Y	10/11/2003	10/12/2003	1	NONE	PVT	PVT	NONE	NONE	ECZEMA			1						1	Irritability	FLU3~SANOFI PASTEUR~U1097AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214356	12/24/2003	CA	2.0	2	.7	M	12/08/2003	Erythema and swelling of left thigh injection site.				Y					Y	12/06/2003	12/07/2003	1		PVT	OTH		NONE	NONE			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1134BA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214357	12/24/2003	WV	71.0	71		M	12/15/2003	(See attached Medwatch form)  [not attached]				Y					Y	11/05/2003	11/07/2003	2	NONE	OTH	PUB	Rofecoxib, Nifedipine, S/m vastatin, Fe Glucomate	NONE				1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U1270AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0664N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0214358	12/24/2003	AR	52.0	52		F	12/11/2003	Arm and shoulder pain, nausea x 2 days. Dizziness and severe headache third evening and day after. Missed work 3rd day.									Y	12/01/2003	12/01/2003	0		PUB	PUB		NONE				1						1	Dizziness; Headache; Nausea; Pain; Shoulder pain	FLU3~SANOFI PASTEUR~U1144AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214359	12/24/2003	AR	19.0	19		M	12/12/2003	Day #3 post vaccine 12/2/03: headache/sore throat. Day #4 post vaccine 12/3/03: body aches/fever. Day #5 post vaccine 12/4/03: Nasal discharge/chest congestion.									Y	11/29/2003	12/02/2003	3		OTH	PUB	NONE	NONE	NONE			1						1	Headache; Nasal congestion; Pain; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1144AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214360	12/24/2003	AR	48.0	48		F	12/11/2003	Arm, neck, shoulder pain. Fever and chills for 3 days.									Y	12/01/2003	12/02/2003	1		PVT	PUB		NONE	NONE			1						1	Chills; Neck pain; Pain; Pyrexia; Shoulder pain	FLU3~SANOFI PASTEUR~01144AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214361	12/24/2003	AR	48.0	48		F	12/12/2003	Day #3 post vaccine 12/2/03: headache/sore throat. Day #4 post vaccine 12/3/03: body aches and fever. Day #5 nasal discharge/chest congestion.									Y	11/29/2003	12/02/2003	3	NONE	OTH	PUB	Asthma inhalers, Albuterol		Chronic asthma			1						1	Headache; Nasal congestion; Pain; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1144AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214362	12/24/2003	AR	53.0	53		M	12/12/2003	Day #3 post vaccine 12/2/03: headache/sore throat. Day #4 12/3/03: body aches/fever (102 degrees). Day #5 nasal discharge/chest congestion.									Y	11/29/2003	12/02/2003	3		OTH	PUB	Lanoxin	NONE	NONE			1						1	Headache; Nasal congestion; Pain; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1144AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214363	12/24/2003	AR	38.0	38		M	12/11/2003	C/o severe headache after receiving flu vaccine.									Y	12/01/2003	12/01/2003	0		PUB	PUB		NONE	NONE			1						1	Headache	FLU3~SANOFI PASTEUR~U1144AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214365	12/24/2003	CT				F		Reported to this writer that 20 minutes after flu shot, pt passed out, felt tightness in throat, was cold and clammy. Given orange juice after which finger stick glucose was 79. O2 sat decreased to 83% at one point. Transferred with EMT via ambulance to hospital. Returned to work next day 11/6/03. The hospital discharge summary received on 1/13/04 states syncope, and rash at inj. site.				Y					Y	11/05/2003	11/05/2003	0		PUB	UNK						1						1	Cold sweat; Injection site rash; Loss of consciousness; Syncope; Throat tightness	FLU3~EVANS VACCINES~765416~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214366	12/24/2003	NM	5.0	5		F	12/16/2003	Area raised and reddened and warm to touch 8:30 PM 12/11/03. Grandmother concerned 12/12/03 and called as induration approx 2 1/4 to 2 1/2. On 12/13/03 took child to ER. Seen by MD, CBC done. Stated infection and MD treated with antibiotic. Rocephin IM and Augmentin tsp every 8 hours.				Y					N	12/11/2003	12/11/2003	0		PUB	PVT	Allegra, Flovent, Flonase	NONE	Chronic asthma, sinus, hayfever			1						1	Infection; Injection site induration; Injection site warmth; Rash erythematous	FLU3~EVANS VACCINES~7766046~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214367	12/24/2003	FL	62.0	62		F	12/18/2003	Starting about 36 hours after injections, severe headache and nausea lasting about 24 hours. No fever or vomiting. It is possible that this was due to other stress and unrelated to shots, but felt it should be reported. Symptoms gone at 72 hours after shots.									Y	12/15/2003	12/17/2003	2		OTH	OTH	NONE	NONE	NONE			1						1	Headache; Nausea	FLU3~SANOFI PASTEUR~U1131AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1212AA~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0214368	12/24/2003	RI	0.59	0	.6	M	12/17/2003	Hives all over body. temperature (fever), flu-like symptoms.				Y					U	12/16/2003	12/17/2003	1		PUB	PUB	NONE					1						1	Influenza like illness; Pyrexia; Urticaria	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~21893B9~2~~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U01111A~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214369	12/24/2003	FL	2.0	2	.7	F	12/18/2003	Patient developed fever T max 106 degrees F 48-52 hours post vaccination. Cold, runny nose. Seen at the ER and diagnosed with ear infection. Treated with antibiotics.				Y					Y	12/11/2003	12/13/2003	2	CBC: WBC 13.3, 60% segr. 21% bands, blood culture negative 48 hours.	PVT	PVT	NONE	NONE	Speech delay			1						1	Ear disorder; Laboratory test abnormal; Pharyngitis; Pyrexia; Rhinitis; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1293AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214370	12/24/2003	FL	61.0	61		M	12/18/2003	24 hours after injection, rash appeared on outer right arm 3 below Pneumovax site. Grew over next 24 hours to 4 diameter semi-disk, swollen, reddened and itchy, especially at lower margins. Applied 2% topical diphenhydramine. At 72 hours after injection, was mostly resolved, still red.									Y	12/15/2003	12/16/2003	1		OTH	OTH	Propranolol, Verapimil	NONE	Hypertension			1						1	Erythema; Injection site erythema; Oedema; Pruritus; Rash	FLU3~SANOFI PASTEUR~U1131AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1212M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0214372	12/24/2003	MO	1.8	1	.8	F	12/11/2003	Seizure arrival at ER temp-102 deg. cough. The ER summary received on 1/29/04 states fussy.				Y					Y	12/05/2003	12/09/2003	4		PUB	PUB			Prematurity			1						1	Convulsion; Cough; Irritability; Pyrexia	FLU3~SANOFI PASTEUR~U1144AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214373	12/24/2003	PA	12.0	12		M	12/19/2003	Hours after vaccine administration pt developed severe neck pain. This lasted for 14 days before history was connected. Spinal tap was negative. Immediate relief a/6 tap.				Y					Y	12/01/2003	12/01/2003	0	Spinal tap negative	PVT	PVT	NONE	NONE	Allergies			1						1	Neck pain	FLU3~SANOFI PASTEUR~U1269AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214374	12/24/2003	FL	41.0	41		F	12/17/2003	Golf ball size knot on arm under injection site, tenderness, redness the size of a half dollar at injection site. No fever or other symptoms. Lasted for approx. 2-3 days. Pt recalled sensitivity to eggs in childhood-stated no allergy.									Y	12/05/2003	12/05/2003	0	NONE	MIL	MIL		NONE	NONE			1						1	Injection site erythema; Injection site mass; Injection site pain	FLU3~EVANS VACCINES~765753~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214375	12/24/2003	MN	23.0	23		F	12/16/2003	Itchy rash, tight muscles, skin felt warm, some tightness in chest.									Y	12/05/2003	12/05/2003	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Chest discomfort; Musculoskeletal stiffness; Pruritus; Rash; Skin warm	FLU3~EVANS VACCINES~765958~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214377	12/24/2003	PA	3.0	3		M	12/18/2003	Father reports acute onset diffuse urticaria on approx. 7 hrs post receiving 1st dose of inactivated flu vaccine 1400 today. REcommended appropriate dose antihistamine product available at home, close observation resp. changes (EMS/ER if occur). Avoid subsequent dosage.									U	12/17/2003	12/17/2003	0		PVT	PVT		NONE	Diabetes insipidus, histiocttusis (remission)			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1133AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214378	12/24/2003	VA	42.0	42		M	12/19/2003	Pt returned to clinic with large area of erythema at the injection site with 86x80mm measurement with warmth to touch. Also a satellite area of erythema with measurements of 50x45mm. These were located at the injection site of Anthrax #4. Pt was given topical steroid, Motrin, no RTC if 5x5 increase.									Y	12/17/2003	12/17/2003	0	NONE	MIL	MIL						1						1	Injection site erythema; Injection site warmth	ANTH~EMERGENT BIOSOLUTIONS~FAV081~4~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~EVANS VACCINES~765753~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~MERCK & CO. INC.~0034N~7+~IM~LA~HEP B (FOREIGN)~1	USA		Influenza
0214410	12/24/2003		30.0	30		F		A report was received from a health care professional on 10/27/03, concerning a 30 year old female vaccinee who was thought to have been pregnant at the time of receiving the Fluvirin vaccine on 10/7/03. On 10/7/03, the vaccinee received Fluvirin but is now thought to have been pregnant, this has yet to be confirmed. There was insufficient info to determine the reporter's causality. Follow up info received from a health care professional indicated that the vaccinee miscarried on 11/10/03. She had a positive pregnantcy test on 10/29/03. Follow-up pending. Upon review of this report was found to be medically significant (OMIC).									U	10/07/2003	11/10/2003	34		UNK	UNK	NONE				PJP200300904	1						1	Abortion spontaneous; Drug administration error	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214421	12/24/2003	NM	5.0	5		F	12/24/2003	On November 27, at approximately 2:30 in the afternoon, the patients body temperature/ fever went up to 104. 5. We gave her a cool bath, then some tylenol.   It came down. The following evening it shot back up, and ibuprfen was given. The evening of 11/27 I contacted the hospital where the vaccine was administered and asked them to fill this form out, they told me I could do it on line. She also developed flu like symptoms. A cough and runny nose.									Y	11/24/2003	11/26/2003	2		UNK	UNK	flovent 44 mg, inhalation	none, just went for pulminary clinic	ashma triggered by colds, reflux, GERD			1						1	Cough; Influenza like illness; Pyrexia; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0214947	12/24/2003	GA	14.0	14		M	12/15/2003	Malaise started 12/11/03.  By 12/12/03, temperature: 101.8-102.8; O2 sat 91%, tachypnea (RR60) and in status asthmaticus.  Headache, sore throat, myalgia, treated with hospitalization, tamiflu 75mg 2 times a day, Prednisone, Albuterol hourly, Singulair, Advair.  Discharged 12/14.  On 12/15 still weak with headache and sinusitis with epistaxis; afebrile, and mild end expiratory wheeze on normal respiratory without shortness of breath.  Diagnosis: flu and status asthmaticus then laster sinusitis.					Y	2			Y	12/09/2003	12/11/2003	2	Viral Culture sent off 12/12/03 (not back yet); Nasal secretions	PVT	PVT	Singulair; Advair; Albuterol;	Chest was clear (very very mild and expiration wheeze for end expiration)	Mild persistant asthma.			1						2	Asthenia; Asthma; Epistaxis; Headache; Influenza; Influenza like illness; Malaise; Myalgia; Pharyngolaryngeal pain; Pyrexia; Sinusitis; Tachypnoea; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500016P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Hospitalisation	Influenza
0210349	12/29/2003		57.0			M	10/15/2003	Hives, urticaria, fever, throat swelling.			Y		Y				U		10/10/2003			UNK	UNK	Divalproex EC, Lorazepam, Flunisolide oral inhaler, Warfarin (Coumadin), Fosinopril, Simvastatin, Rofecoxib, Trazodone HCl, Magnesium oxide, Ranitidine HCl, Menthol 10%/Methyl Sal 15% cream, Gabapentin, Albuterol oral inhaler					1						2	Asthenia; Chest discomfort; Dyspnoea; Feeling hot; Hot flush; Pharyngeal oedema; Pharyngeal oedema; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U1268AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation	Influenza
0210777	12/29/2003	TX	25.0	25		M	12/17/2003	Probable smallpox-associated myopericarditis. Most of history obtained from inpatient record from hospital (when pt contacted x 2 while in hospital, he requested case manager call him back. Several messages left on answering machine at home phone number, but pt did not return phone calls to case manager. Pt contacted by phone on evening of 11/26, and clinical summary completed). On early morning of 10/18/03, pt began experiencing chest pain and  SOB. He awoke around 0200 with upper back pain, which was attributed to a pulled muscle. The pain persisted, and around 0800, he developed substernal chest pain that radiated to his upper extremities and upper back. Pt took Motrin for pain relief, but the pain persisted. Around 1500 on 10/19/03, the intensity of the chest pain had increased to a level 9 of 10 on a pain scale and was accompanied by SOB, nausea, diaphoresis, dizziness, and palpitations. He denied peripheral edema, cough, or orthopnea. Pt has no positive risk factors for coronary artery disease, except mother has history of heart disease. (Had CABG at age 61). Pt was admitted on 10/19/03. After receiving IV toradol in the ER, he was asymptomatic at the time of admission. On his first hospital day, while on telemetry, he experienced an asymptomatic, 4-beat run of V-tach. During his hospitalization, his maximum temp was 102.9 on hospital day 1. During his 5-day hospital course, echocardiograms, MRI with gadolinium, cardiac catheterization, and cardiac biopsy were completed. Pt was discharged on 10/22/03 on 8 weeks of leave. On 10/16, experienced sore throat, fever and chills. Placed on quarters x 24 hrs. On 10/17, felt fine. Awoke at 0200 on 10/18 with pain in middle of back, by shoulders, nausea, SOB and dizziness. No cough, myalgias or headaches. Smallpox site with typical progression to pustule. Scab fell off on day 21.					Y	3			Y	10/14/2003	10/18/2003	4	10/19/03 CXR: no infiltrates, no masses, no effusions, no CHF, no pneumonia. 10/19/03 bedside transthoracic echocardiogram: preserved LVEF-qualitative 55-65%, quantitative by fractional shortening, 55%, No focal regional wall motion abnormalities. No evidence of effusions. No MR. Trileaflet, aortic valve with appropriate take-off of at least left main coronary artery from left cusp of sinus of valsalva. 10/20/03 echocardiogram-left ventricular systolic function was mild-to-moderately decreased. Left ventricular ejection fraction was estimated, range being 35-45%. There was mild diffuse left ventricular hypokinesis. Left ventricular diastolic function parameters were normal. Left ventricular wall thickness was normal. Normal transmitral flow patter. Pulmonary vein flow pattern was normal. No pericardial effusion. The pericadium was normal in appearance. Aortic valve was trileaflet. Aortic valve thickness was normal. No evidence for aortic valve stenosis. No significant aortic valvular regurgitation. Aortic root was normal in size. Trivial mitral valvular regurgitation. left atrial size was normal. Trivial pulmonic regurgitation. Right ventricular size was normal. Right ventricular systolic function was normal. Trivial tricuspid valvular regurgitation. Right atrial size was normal. Inferior vena cava was normal. 10/20/03 MRI with gadolinium (cardiac structure): thickening of the inverventricular septum and left ventricular myocardial wall. Exam is limited to evaluate for abnormal enhancement of the apical and lateral wall of the left ventricular myocardium. The posterior-inferior wall is within normal limits without abnormal signal intensity or enhancement to suggest myocarditis. There is also dilatation of the left ventricular chamber. 10/21/03 cardiac catheterization-normal coronary artery take-off and distribution. No evidence of obstructive disease. LVEDP 13mmHg, with LVERF 40-45% with global mild hypokinesis.	MIL	MIL	NONE	NONE	NONE			1						2	Myocarditis; Pericarditis; Back pain; Chest pain; Chills; Dizziness; Dyspnoea; Hyperhidrosis; Injection site pustule; Laboratory test abnormal; Nausea; Palpitations; Pericarditis; Pharyngolaryngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1|FLUX~UNKNOWN MANUFACTURER~765141~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|SMALL~PFIZER\WYETH~4020071~1~SC~LA~SMALLPOX (DRYVAX)~2|TYP~SANOFI PASTEUR~W0909~2~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~2	USA	Hospitalisation	Influenza
0214446	12/29/2003	PA	65.0	65		F	12/17/2003	6 hrs after my pneumonia shot my right upper arm and neck became swollen. Sat. morning the fluid and swelling appeared in the lower part of right arm. I had constant pain where I was given the shot. After 2 doctor's visits I was given the proper emds and 2 1/2 wks later was okay.				Y					Y	11/14/2003	11/14/2003	0	NONE	PVT	PVT	Aspirin, Premarin, Prinzide	NONE	Dextromethonphan			1						1	Abscess drainage; Injection site pain; Neck pain; Oedema peripheral	FLU3~EVANS VACCINES~764952~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0214447	12/29/2003	FL	75.0	75		F	12/26/2003	Vaccine administered 10/25/03 L deltoid region arm. No symptoms x 1 month, approx. 2 weeks from 12/26/03 noticed a somewhat painful no palpation 3/4cms cystic area at vaccination site. No fever. No redness. No neurologic symptoms. Skin normal appearance. Plan is to observe to ER if it appears or needs incision.									U	10/25/2003	12/10/2003	46	NONE	PVT	PVT	Verapamil, Clonidine, Cozaar, Nitro SR caps, hydrochlorothiazine, Lopressor, Premarin, Rot. Chlor SR, Ultram, Pravachol, Famotidine,	NONE	Hypertension, angina			1						1	Injection site cyst; Pain	FLU3~SANOFI PASTEUR~765666~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214448	12/29/2003	CO	50.0	50		F	12/16/2003	2 Hours after flu vaccine patient became dizzy and lightheaded.  Symptoms progressed (+) vertigo, (+) weakness. Exam was essentially normal; Benadryl prescribed, symptoms resolved in 36 hours.				Y					Y	12/12/2003	12/12/2003	0	NONE	OTH	PVT	Prozac; Combipatch;	NONE	Allergic to Rogaine; Epinephrine; Perfumes;			1						1	Asthenia; Dizziness; Vertigo	FLU3~EVANS VACCINES~765751~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214449	12/29/2003	LA	53.0	73		F	12/24/2003	9x9cm pale erythematous macular with 4x4cm central nodularity, more red, increased sleepiness, lesion pruritic body aches.									Y	12/22/2003	12/22/2003	0	NONE	PVT	PVT	NONE	Sacroilitis; Headaches;	NONE			1						1	Erythema; Injection site nodule; Pain; Pruritus; Skin ulcer; Somnolence	FLU3~EVANS VACCINES~965958~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214450	12/29/2003	WA	52.0	52		F		Arm swelling									U	12/05/2003	12/08/2003	3		PVT	UNK						1						1	Oedema	FLU3~EVANS VACCINES~765853~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214451	12/29/2003	CA	4.0	4		F	12/12/2003	Bells Palsy right side of face (V1, V2, V3) area noted 23.5 hrs after immunizations. Head CT 12 hrs later=WNL. Prescribed Prelone + ACV orally. Improving but not resolved at the time of report.  Nurse follow up on 08/19/04 states: Right sided facial weakness.				Y					U	12/05/2003	12/06/2003	1	Head CT scan: normal	MIL	OTH			Status post LMCA CVA in utero; seizure;			1						1	Facial palsy; Muscular weakness	DTAP~UNKNOWN MANUFACTURER~~5~UN~UN~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~4~UN~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~2~UN~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0214454	12/29/2003	SD	1.0	0	1	F	12/11/2003	Measles rash all over body.				Y					Y	11/26/2003	12/07/2003	11	IgM; Urine culture;	PVT	OTH	NONE	NONE	NONE		SC03031	1						1	Rash morbilliform	FLU3~SANOFI PASTEUR~U1112AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0511N~1~SC~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|VARCEL~MERCK & CO. INC.~0830N~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0214523	12/29/2003	WI	51.0	51		F	12/29/2003	Client reported feeling itchy all over, and burning of her skin.  Client denied hives or other rashes. Client states her lips might have been swollen - she is unsure, also states she had trouble sleeping.									Y	12/22/2003	12/22/2003	0	Client did not seek medical attention.	PUB	PUB		None	Asthma, allergic to PCN advised by MD to avoid sulfa meds			1						1	Face oedema; Insomnia; Pruritus; Skin burning sensation	FLU3~EVANS VACCINES~765851~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214524	12/29/2003	CA	38.0	38		M	12/29/2003	Dec 12 received both the influenza and anthrax vaccine 1500 hrs. Returned home at 2300 hrs. Ate a sandwich and prepared for bed. Other than feeling a little achy and tired reported no problems and denied fever. Went to bed at 2400 and feel asleep immediately. Next thing he remembers is awakening at 0030. Has no recall of events for the previous 30 min.  Pt states that his wife reported that he started to shake gradually all over his body and that she was unable to wake him up so she called 911. Stated that shaking lasted 30 60 sec. and that the 911 operator told his wife to place him on his side. Stated that he was gurgling and that breathing was laboured. Reported that he had a small amount of emesis.  Was transported to hospital, blood and urine tests were normal and he was later released at 0500.  Pt denies any incontinence, no trauma to mouth. Never had anything like this before and that he is currently feeling fine.				Y					Y	12/11/2003	12/12/2003	1	told bld and urine test was neg. Pending MRI results and neuro evaluation	MIL	MIL	denies	denies	penicillin	Persistent arm and shoulder pain for greater than 1 month~Anthrax (Biothrax)~2~33.90~In Patient		1						1	Dyspnoea; Fatigue; Pain; Tremor; Vomiting	ANTH~EMERGENT BIOSOLUTIONS~Fav080~5~SC~UN~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~765756~7+~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0214526	12/29/2003	NC	54.0	54		M	12/29/2003	Confusion and vertigo beginning 22 hours after vaccination.  Evaluated in ER and admitted. Significantly impaired level of consciousness. Heparin bolus and IV followed by Coumadin.  Gradual recovery over 4 days. The discharge summary received on 2/24/04 states headache and venous thrombosis. The medical records received on 2/24/04 states sinusitis, aphsia, ataxia, and aberrant rt vertebral vessel.			Y	Y	Y				Y	12/02/2003	12/03/2003	1	MRI: venous sinus thrombosis of right and left sigmoid sinus, transverse sinus, and possibly internal cerebral veins.  Patchy T2 signal involving right frontal and bilateral ethmoid air cells,consistent with inflammatory change; several large mucus retention cysts within the inferior aspects of both maxillary sinuses.  No acute sinusitis, headache, trauma, prior thrombotic episode, or acquired risk factors prior to occurance.  CSF WBC=0, RBC=40, CSF Prot&gluc=Within Normal Limits(WNL).  Prothrombin 20210 mutation=neg, Factor V Leiden=neg, Lupus anticoagulant=WNL Cardiolipin Antibodies=neg, AT III& Prot S=WNL, Prot C=sl elevated (drawn 10 hours after presentation - WNL at 24 hours).	PVT	PVT	Lipitor 20mg daily  Prior flu vaccinations in 1974 & 1975.  No others until 2003 dose.	None known.  Chronic sinusitis by MRI.	Hyperlipidemia, obesity			1						1	Angiopathy; Aphasia; Confusional state; Coordination abnormal; Depressed level of consciousness; Headache; Laboratory test abnormal; Sinusitis; Thrombophlebitis; Vertigo	FLU3~EVANS VACCINES~765876~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0213610	12/30/2003	TX				F	01/23/2004	A health care professional reported that a female pt received a dose of Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on an unspecified date. The pt developed an anaphylactic reaction approximately 15 to 20 minutes after receiving a dose of FluMist. Treatment information was not provided. This case was considered medically important (OMIC). The reporter indicated that the event has been reported to VAERS.  No additional information was available at the time of this report. Follow-up information was received on 14-Jan-2004 from a physician which provided medical history, Immunization date and time, and additional adverse event information. On 05-Dec-2003, at 1:50 pm, a female patient received a dose of Flumist at her employer's health services office. She was observed for 10 minutes after receiving the vaccine. The reporter indicated that there was no problems and the patient returned to work. Approximately 15 to 20 minutes post-immunization, the patient developed an anaphylactic reaction characterized by numbness of her tongue, lips and throat with difficulty breathing. She returned to the health services office. Upon physical examnation her blood pressure was 106/66. pulse 76, respiration 16. Lung exam was negative for audible wheezing. A pulse oximetry was performed the results were 98 % on room ari. All serial blood pressures were reported to be  within normal limits. She was treated with epinephrine 1:1000 (0.3mL). The patient then felt chest pain and had a sensation that her throat was closing. Emergency medical services were contacted and the patient was transported to the emergency departemtn. She was treated with Benadryl and observed for 4 to 6 hours. On that sam day, the patient was discharged from the emergency room. The reporter indicated that this event has been reporterd to VAERS. This case was considered mecially important. (OMIC)									U	12/05/2003	12/05/2003	0	UNK	OTH	OTH	UNK	UNK	Hypersensitivity (LLT: Allergy)		HQWYE493409DEC03	1						2	Dyspnoea; Hypoaesthesia; Tracheal oedema; Anaphylactic reaction; Chest pain; Dyspnoea; Hypoaesthesia; Throat tightness	FLUN3~MEDIMMUNE VACCINES, INC.~500020P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0214466	12/30/2003	TX	49.0			F	12/24/2003	A 49 year old female consumer reported that she received an injection of influenza virus vaccine on an unspecified date sometime during 2002 and developed an allergic reaction. The reporter indicated that she has experienced an allergic reaction to the flu shot for the past several years. She stated that she experienced a different reaction every year, and that the reactions became progressively worse. Initially, she developed an injection site reaction characterized by a red welt. In subsequent years, she developed swelling of the injected arm, a rash from the top to the bottom of her body, swelling of her body and an injection site reaction characterized by a painful, itchy, red welt. On an unspecified date during 2002, her physician administered an unspecified injection at the same time she received the flu shot. The reporter indicated that the allergic reaction cleared pretty quickly once the other shot was given. This event was considered medically important (OMIC). No additional info was available at the time of this report.				Y					Y				UNK	OTH	OTH	UNK	UNK	Fibrocystic breast disease; seasonal allergies; allergic to caffeine, Mycitracin, Neosporin, and Bacitracin. She reports feeling bad after eating eggs.		HQWYE857122DEC03	1						1	Hypersensitivity; Injection site hypersensitivity; Injection site pain; Injection site reaction; Oedema peripheral; Pruritus; Rash; Urticaria; Vaccine positive rechallenge	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0214473	12/30/2003		36.0			M	12/18/2003	A consumer reported that her 36 year old husband received a dose of FluMist on an unspecified date in 2003. On 12/13/03, he experienced dizziness and was subsequently involved in a car accident. The reporter indicated that the event was life-threatening. No additional information was available at the time of this report.			Y						U		12/13/2003		UNK	OTH	OTH	UNK	UNK	UNK		HQWYE637416DEC03	1						1	Dizziness; Road traffic accident	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Life Threatening	Influenza
0214474	12/30/2003	MD	9.0	9		M	12/19/2003	This case was considered medically important (OMIC). Information regarding FluMist was received from the father of a 9 year old male who experienced retinal bleeding. AT 9 years of age, the child received a dose on 12/11/03. Upon awakening on 12/12/03, the child noticed black spots in the vision of his left eye. He was seen by an eye doctor who reported bleeding in the retina but no detachment. The father indicated that his son's vision is improving but the spots persisted as of 12/12/03. The child's physician reported that he spoke with the mother of the patient and confirmed this event is accurate.No additional info was available at the time of this report. Follow-up information received from the physician provided confirmation of the event.				Y					U	12/11/2003	12/12/2003	1	UNK	PVT	PVT	NONE	NONE	UNK		HQWYE687817DEC03	1						1	Retinal haemorrhage; Visual disturbance	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0214475	12/30/2003	IN	41.0	41		F	12/19/2003	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a 41 year old female pt who experienced pleurisy, inflammation, shortness of breath and chest pain.  At 41 years of age, the pt received a dose on 12/09/2003.  The pt who worked in the reporting physician's office, developed chest pain (chest pain) in the evening of 12/14/2003.  The next day, she was still complaining of chest pain and shortness of breath (dyspnoea).  An EKG was performed and it was abnormal.  The pt was given nitroglycerin every five minutes for three doses.  That same day, she was admitted to the hospital.  Her chest pain continued through the night.  She was diagnosed with pleurisy (pleurisy) and inflammation (inflammation).  On 12/16/2003, she was discharged from the hospital. Test Results: Electrocardiogram (results: abnormal) was done on 15-Dec-2003. Additionally, fibrin D dimer (results: increased) was done on an unspecified date. No additional information was available at the date of this report. Follow-up information received from the patient's physician provided event outcome and county where vaccine was administered. She recovered.				Y	Y				U	12/09/2003	12/14/2003	5	ECG: abnormal; Fibrin D dimer: increased	OTH	OTH	Unspecified contraceptive	NONE	UNK		HQWYE686917DEC03	1						1	Chest pain; Dyspnoea; Electrocardiogram abnormal; Fibrin increased; Oedema; Pleurisy	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0214477	12/30/2003	IL	5.0	5		F	11/07/2003	Vomiting about 24 hours post vaccine.  Muscle spasms off hands and feet with pronounced tonic turning inward movements).  Hospitalized for 1 day. Mother with tingling sensation in hands post vaccination. Grandfather with rigors/extremity spasms also.  Nurse follow up on 08/04/04 states: headache, upper abd pain/					Y	1			Y	11/03/2003	11/04/2003	1	Normal electrolytes; Ca; elevated WBC; Urinalysis abnormal;	PVT	OTH	NONE	Upper respiratory infection	Asthma			1						1	Abdominal pain; Headache; Laboratory test abnormal; Leukocytosis; Muscle spasms; Vomiting	FLU3~EVANS VACCINES~765959~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0214478	12/30/2003	FL	46.0	46		F	12/12/2003	Angioedema the day after vaccine but feel sick after vaccine.  Angioedema for the first time in my life-healed itself then returned again. Extensive allergist test followed allergist can't find the cause			Y						U	11/06/2003	11/06/2003	0	Blood tests; skin tests;allergy test Abnorm	OTH	PVT	NONE	NONE	NONE			1						1	Angioneurotic oedema; Laboratory test abnormal; Malaise	FLU3~SANOFI PASTEUR~U1075AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0214482	12/30/2003	CA	58.0	58		F	12/19/2003	Left deltoid red and warm two days after flu shot. Arm examined 12/11/03 and no longer red. Pt says redness lasted only 2-3 days and is fine now.									Y	12/04/2003	12/05/2003	1		PVT	UNK		NONE	NONE			1						1	Feeling hot; Injection site erythema	FLU3~EVANS VACCINES~765144~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214483	12/30/2003	MA	56.0	56		F	12/08/2003	Received shot 12/4/03 about 3:00 PM. No reaction at that time. 12/5/03 awoke in AM with headache and feeling flush. Approx 9-9:30 noticed hives to arms (due to itching). Took Benadryl 50mg and went home. Called Infection Control and private MD.									Y	12/04/2003	12/05/2003	1		PVT	UNK	Prozac, Bextra	NONE	NONE	headaches~Influenza (Seasonal) (no brand name)~1~35.00~In Patient		1						1	Flushing; Headache; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~D1102AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214484	12/30/2003	WI	1.33	1	.3	F	12/23/2003	Friday morning 2:00 AM fevers of 104.5 and higher for 3 full days. Hives, wouldn't eat or drink. Hardly slept. Took them 10 full days until December 12 to call me and tell me they accidentally gave her the adult flu shot.				Y					Y	12/02/2003	12/05/2003	3	Throat culture/Uti culture: negative	PVT	OTH	Moxicillin	NONE	Born 6 weeks early			1						1	Anorexia; Insomnia; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0214485	12/30/2003	IN	41.0	41		M	12/06/2003	1 hour after receiving this vaccine pt reported to Medical Squadron with c/o metallic taste in mouth and hiccups. Hiccups continued for 2 days. Was seen in ER given Phenergan 25mg IM. Reglan 10mg and viscous Lidocaine.				Y					Y	11/01/2003	11/01/2003	0	NONE	MIL	MIL	NONE	NONE				1						1	Dysgeusia; Hiccups	FLU3~EVANS VACCINES~765754~7+~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214486	12/30/2003	CA	43.0	43		F	12/22/2003	Had flu shot 12/16/2003. 3 days later, Friday, 12/19/2003 rash developed. Rash all over body. Some itching mostly today, Monday, 12/22/2003.									U	12/16/2003	12/19/2003	3	NONE	PUB	PUB	Insulin, Zoloft, Synthroid, Albuterol	NONE	Allergy to erythromycin			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U1097AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214488	12/30/2003	UT	4.0	4		M	12/15/2003	4 days after receiving Influenza shot, leg became red and developed temperature of 100 degrees. 7 days after receiving shot saw physician. Then had red papules, 1 on each leg which was firm, pale center, surrounding erythema. Given Zyrtec, Benadryl.				Y					U	12/02/2003	12/06/2003	4		PVT	PVT	Albuterol, Zyrtec	NONE	Asthma, nasal allergies			1						1	Erythema; Pyrexia; Rash papular	FLU3~SANOFI PASTEUR~U1170AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214489	12/30/2003	SD	1.42	1	.5	M	12/17/2003	Mom stated child became ill and she took him to their PA on Wed December 3. He had bronchitis. PA did not feel there was any relationship of his illness to vaccines. He had seen PA on Nov 25, the day before immunizations were given and he was fine then.				Y					Y	11/26/2003	12/03/2003	7		PUB	PUB		NONE	Recurring URI and ear infections - behind in immunizations		SD03030	1						1	Bronchitis	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~21893E9~1~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1140AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UA850AA~3~IM~LL~HIB (PROHIBIT)~1	USA	Emergency room visit	Influenza
0214490	12/30/2003	ME	75.0			F	12/11/2003	Pt shrieked while sitting in chair, arched back and neck, flailed her arms and legs. This lasted about 2 minutes. The pt was unresponsive with rapid breathing and eyes rolled back. By 6:30 AM, pt responsive to touch and speech. No injuries, no incontinence, breathing normal.				Y					Y	11/04/2003	11/05/2003	1	BP 112/60, P 112, Resp 78, Temp 97.8. EEG could not rule out seizure.	PUB	UNK			Schizophrenia			1						1	Coma; Eye movement disorder; Opisthotonus; Respiratory rate increased; Screaming	FLU3~SANOFI PASTEUR~U1133AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0865N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0214491	12/30/2003	LA	9.0	9		F	12/16/2003	Mother talked to PHN per phone 12/16. Stated shortly after vaccination administered to daughter (12/15), pt became hoarse and started crying and screaming about pain to right arm, site of flu vaccine. Denied shortness of breath. Mother referred to ER. Daughter was not crying then, stated she didn't want to cry in front of the nurses and doctors. They (ER?) will have her incident reported (I am assuming she was not seen by MD - that the mother telephoned and she was referred to ER then). Daughter was assessed, no procedures administered. Mother stated arm looked fine with exception of red splotchiness to entire arm like spider veins - or the way your face does when you cry a lot.				Y					Y	12/15/2003	12/15/2003	0		OTH	PUB	NONE	c/o sore throat in AM	NONE		LA031202	1						1	Agitation; Crying; Dysphonia; Pain; Rash maculo-papular	FLU3~SANOFI PASTEUR~U1094AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214495	12/30/2003	CA	81.0	81		F	12/19/2003	2nd done: well delineated slightly raised, erythematous welt 5x6cm.  Resolved promptly!									Y	12/10/2003	12/11/2003	1	NONE	PVT	PVT	NONE	NONE	CAD; Angina; Osteoporosis, MI			1						1	Erythema; Injection site swelling	FLU3~EVANS VACCINES~765873~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0987N~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0214496	12/30/2003		38.0	38		F	12/13/2003	Warm, red, swollen area approximated 2x2 inches at injection site.									U	12/11/2003	12/13/2003	2	NONE	PVT	MIL	NONE	NONE	NONE			1						1	Feeling hot; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1270AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214497	12/30/2003	VT	1.0	1	.0	M	12/22/2003	Rash over face and trunk; diffuse papular starting on 12/20/03.  No fever or malaise.				Y					U	12/12/2003	12/20/2003	8	NONE	PUB	OTH	NONE	NONE	NONE			1						1	Rash papular	FLU3~SANOFI PASTEUR~U1133AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0611N~1~SC~LL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|VARCEL~MERCK & CO. INC.~0896N~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0214499	12/30/2003	CA	49.0	49		F	12/22/2003	Rash, severe itching since 10/24/03 until present have been to ER twice MD office on 12/16/03.				Y					N	10/22/2003	10/24/2003	2	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Rash pruritic	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0214500	12/30/2003	OK	27.0	27		F	12/19/2003	Pt received vaccine on 12/18/2003 @ 1600.  Reported to immunization clinic on 12/19/2003 @ 1330 with complained of red, tender, painful, swelling, at immunization site.  Pt seen by flight surgeon.									Y	12/18/2003	12/18/2003	0	NONE	MIL	MIL	NONE	NONE	Sulfa-hives/edema, bulemia, Obsessive-compulsive disorder; major depression			1						1	Injection site erythema; Injection site oedema; Injection site pain; Tenderness	FLU3~EVANS VACCINES~765754~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214501	12/30/2003	MS	31.0	31		M	12/10/2003	10 cm of ecchymoses/induration associated malaise, myalgias, arthralgias and fever.									Y	12/04/2003	12/06/2003	2	NONE	MIL	MIL	Prilosec; Motrin	NONE	Cipro; GERD			1						1	Arthralgia; Ecchymosis; Injection site induration; Malaise; Myalgia; Pyrexia	ANTH~EMERGENT BIOSOLUTIONS~FAV080~4~IM~LA~ANTHRAX (BIOTHRAX)~1|FLU3~EVANS VACCINES~765756~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214515	12/30/2003	NH	62.0	61		F	12/11/2003	Hives developed all over about 10 pm, while at work.  Vaccine administered at 11:00am same day.  Lips swollen and difficulty breathing.  Pt went to clinic ER for tx.				Y					Y	12/01/2003	12/01/2003	0	NONE	PVT	PVT	Estropate; Imipramine; Lipitor; HCTZ; Cuptopril; Avandia; Cordeiu;	NONE	Allergic to Ceclor (hives), HTN, NIDDM (Diabetes mellitus)			1						1	Dyspnoea; Face oedema; Urticaria	FLU3~EVANS VACCINES~765978~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214564	12/30/2003	NC	43.0	43		M	12/30/2003	I received an influenza vaccination on October 27, 2003; I broke out in hives the following day.  I have been sporadically breaking out in hives during the past 2 months; specific reason for outbreak unknown.  I had no known allergies prior to the breakout.  Appears I may possibly be allergic to chocolate now, though not confirmed.  I saw a doctor and was prescribed prednisone and diphenhydramine.  Medication has had little effect.				Y					N	10/27/2003	10/28/2003	1	No tests or laboratory work done.	MIL	MIL	None	None	None			1						1	Hypersensitivity; Urticaria	FLU3~SANOFI PASTEUR~U127OAA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214568	12/30/2003	MO	26.0	26		F	12/22/2003	Spot where injection given feels as if indented in skin, grey, feels wierd, like my muscle tissue is dying.									Y	12/05/2003	12/15/2003	10	has not seen doctor, encouraged to do so.  Seen doctor on 12-30-03.	UNK	UNK			This happened when she was younger when she would receive her childhood vaccinations.		MO2003109	1						1	Skin discolouration; Skin reaction	FLU3~SANOFI PASTEUR~1253AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214569	12/30/2003	AL	0.8	0	.8	F	12/30/2003	Patient began crying and acting as if really bad stomach ache and passing lots of gas, then ears started swelling, trunk area turned red, then eyes and lips swoll and whole body turned red and a fast heart beat  Vaccine was the Aventis U1143AA type				Y					Y	12/09/2003	12/10/2003	1	given a shot of benadryl and prednisone in emergency room and went to pediatrician next morning and put on prednisone for a week	PVT	PVT	Prilosec	none	born with low birth rate, but was doing fine and on the growth chart, baby was doing much better and everything was fine at time of vaccine			1						1	Abdominal pain upper; Crying; Erythema; Eye oedema; Face oedema; Flatulence; Heart rate increased; Oedema	FLU3~SANOFI PASTEUR~U1143AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0212869	12/31/2003		54.0			M	12/30/2003	Information has been received from a health authority and a health professional concerning a 54 year old male with hyperlipidaemia, degenerative joint disease of both ankles, osteoarthritis, a history of migraines (now resolved), and left shoulder surgery. The pt denies any past history of HTN, angina, CHF, CVA, valvular heart disease, diabetes, asthma, cancer or thyroid disease. The pt reported that he sometimes became short of breath after exercise, but that this was baseline for him. On 2/2/03 the pt was vaccinated SC with a first dose of anthrax vaccine. On 2/15/03 the pt was vaccinated IM with a first dose of hep A vaccine, a first dose given IM of hep B, a first dose given SC of yellow fever vaccine , a second dose given intradermally in the left arm  of smallpox vaccine, a first dose given SC of Menomune, a third dose given IM of influenza virus vaccine and a second dose given SC in the left arm of anthrax vacine. Concomitant therapy included Altace 2.5mg PO daily, aspirin 325mg PO daily, Imdur 30mg PO daily, Lipitor 10mg PO daily, Lopressor 25mg PO daily and Flavix 75mg PO daily. On 3/5/03 the pt was vaccinated SC with a thrid dose of anthrax vaccine. On 9/22/03 a radiologic examination revealed the lungs to be mildly hyperinflated but clear of infiltrate. The heart and pulmonary vessels appeared to be normal size. The impression was a non-specific hyperinflation and focal degenerative changes of the left distal clavicle of the AC joint. On 10/2/03 the pt recalled feeling heeartburn while resting which he described the sensation as a burning feeling in the middle of his chest and rated it as a 6 out of 10 on a pain scale. On 10/3/03 the pt was seen in the ER where he was diagnosed with a myocardial infarction. The pt's medical records noted that he had experienced intermittent chest pain/ pressure at rest for two to three weeks. He had elevated cardiac enzymes, an initial EKG with ST elevation in Lead III, and subsequent T wave inversion in leads II, III and AVF. The pt was hospitalized and underwent a  cardiac catheterization with stent placement. Mild posterior wall hypokinesis was revealed. The left heart catheterization and left ventriculogram and coronary angiogram revealed severe two-vessel coronary artery disease with the right coronary artery being the culprit of the pt's recent non Q myocardial infarction. The left anterior descending artery was of very small caliber. It was not optimal for surgical intervention. There was normal left ventricular systolic function. Gated apect images of the heart were obtained after the pt's recovery, which revealed the left ventricular ejection fraction is calculated to be 66% and wall motion is good. The impression from the Cardiolite Scan was an abnormal perfusion study with ischemia in the inferolateral wall region. The pt was discharged from the hospital and since his discharge he has denied any further chest pain or heartburn type symptoms. The pt was schedule for another stress test on 11/15/03. His recovery status is currently unknown. It was also noted that the pt stated that he was concerned that the vaccination he had received may have contributed to his cardiac problems. Myocardial infarction was considered to be immediately life-threatening and an other important medical event (OMIC). No further info is available.			Y	Y	Y				N	02/15/2003	09/01/2003	198		OTH	OTH	Aspirin, Lipitor, Plavix, Imdur, Lopressor, Altace		Migraine, shoulder operation, hyperlipidaemia, breath shortness, osteoarthritis, degenerative joint disease		WAES0312USA02512	1						3	Chest pain; Dyspepsia; Dyspnoea; Laboratory test abnormal; Myocardial infarction; Laboratory test abnormal; Myocardial infarction; Chest pain; Myocardial infarction; Chest pain; Dyspepsia; Laboratory test abnormal; Myocardial infarction; Myocardial ischaemia	ANTH~EMERGENT BIOSOLUTIONS~Unknown~2~SC~LA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~Unknown~3~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~5377AA~1~~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~0980M~1~IM~UN~HEP A (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~UB269AA~1~SC~UN~MENINGOCOCCAL (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4020071~2~ID~LA~SMALLPOX (DRYVAX)~1|YF~UNKNOWN MANUFACTURER~UB358AA~1~SC~UN~YELLOW FEVER (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~3~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|MEN~SANOFI PASTEUR~UB269AA~1~SC~~MENINGOCOCCAL (MENOMUNE)~2|SMALL~PFIZER\WYETH~4020071~2~ID~LA~SMALLPOX (DRYVAX)~2|YF~SANOFI PASTEUR~UB358AA~1~SC~~YELLOW FEVER (YF-VAX)~2|ANTH~EMERGENT BIOSOLUTIONS~~2~SC~LA~ANTHRAX (BIOTHRAX)~3|FLUX~UNKNOWN MANUFACTURER~~3~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|HEP~UNKNOWN MANUFACTURER~5377AA~1~IM~UN~HEP B (NO BRAND NAME)~3|HEPA~MERCK & CO. INC.~0980M~1~IM~~HEP A (VAQTA)~3|MEN~SANOFI PASTEUR~UB269AA~1~SC~~MENINGOCOCCAL (MENOMUNE)~3|SMALL~PFIZER\WYETH~4020071~2~ID~LA~SMALLPOX (DRYVAX)~3|YF~SANOFI PASTEUR~UB358AA~1~SC~~YELLOW FEVER (YF-VAX)~3|ANTH~EMERGENT BIOSOLUTIONS~~2~SC~~ANTHRAX (BIOTHRAX)~4|FLUX~UNKNOWN MANUFACTURER~~3~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~4|HEP~MERCK & CO. INC.~~1~IM~~HEP B (RECOMBIVAX HB)~4|HEPA~MERCK & CO. INC.~0980M~1~IM~~HEP A (VAQTA)~4|MEN~SANOFI PASTEUR~~1~IM~~MENINGOCOCCAL (MENOMUNE)~4|SMALL~PFIZER\WYETH~~2~SC~~SMALLPOX (DRYVAX)~4|YF~SANOFI PASTEUR~~1~SC~~YELLOW FEVER (YF-VAX)~4	USA	Life Threatening,Hospitalisation	Influenza
0212869	12/31/2003		54.0			M	12/30/2003	Information has been received from a health authority and a health professional concerning a 54 year old male with hyperlipidemia, degenerative joint disease of both ankles, osteoarthritis, a history of migraines (now resolved), and left shoulder surgery.  The pt denies any past history of hypertension, angina, CHF, CVA, valvular heart disease, diabetes, asthma, cancer or thyroid disease.  The pt reported that he sometimes became short of breath after exercise, but that this was baseline for him.  On 02/02/2003 the pt was vaccinated SC with a first dose of AVA (batch FAV073).  On 02/15/03 the pt was vaccinated IM with a first dose of Hep A (inactive)(Lot # 644168/0980M)(manufacturer unknown), a first dose given intramuscularly of hepatitis B virus vaccine, a first dose given SC of yellow fever virus vaccine (YF-VAX)(Batch # UB358AA), a second dose given ID in the left arm of SP vaccine (Dryvax)(Batch #4020071), a first dose given SC of meningococcal ACYW polysaccharide vaccine (Menomune)(Batch #UB269AA), a third dose given IM of influenza virus vaccine (unspecified), and a second dose given SC in the left arm of AVA vaccine (Biothrax). Concomitant therapy included ramipril (Altace) 2.5mg per mouth daily, aspirin 325 mg per mouth daily, isosorbide mononitrate (Imdur) 30mg per mouth daily, atorvastatin calcium (Lipitor) 10 mg per mouth daily, metoprolol tartrate (Lopressor) 25mg per mouth daily, and clopidogrel bisulfate (Plavix) 75mg per mouth daily.  On 03/05/2003 the pt was vaccinated SC with a third dose of ANA (Biothrax).  On 09/22/03 a radiologic examination revealed the lungs to be mildly hyperinflated but clear of infiltrate.  The heart and pulmonary vessels appeared to be normal size.  The impression was a non-specific hyperinflation and focal degenerative changes of the left distal clavicle of the AC joint  On 10/02/03 the pt recalled feeling heartburn while resting which he described as a strong urge to burp, but he was unable to do so.  It was reported that the pt described the sensation as a burning feeling in the middle of his chest and rated it as a 6 out of 10 on a pain scale.  On 10/03/03 the pt was seen in the ER where he was diagnosed with a MI.  The pt's medical records noted that he had experienced intermittent chest pain/pressure at rest for two to three weeks.  He had elevated cardicac enzymes, an initial EKG with ST elevation in Lead III, and subsequent T wave inversion in leads II, III and catherterization with stent placement.  Mild posterior wall hypokinesis was revealed.  The left heart catherization and left ventriculogram and coronary angiogram revealed severe two-vessel coronary artery disease with the right coronary artery being the culprit of the pt's recent non Q MI.  The left anterior descending artery was of very small caliber.  It was not optimal for surgical intervention.  Ther was normal left ventricular systolic function.  Gated spect images of the heart were obtained after the pts recovery, which revealed the left ventricular ejection fraction is calculated to be 66% and wall motion is good.  The impression from the Cardiolite Scan was an abnormal perfusion study with ischemia in the inferolateral wall region.  The pt was discharged from the hospital and since his discharge he has denied any further chest pain or heartburn type symptoms.  The pt was schedule for another stress test on 11/15/03.  His recovery status is currently unknown.  It was also noted that the pt stated that he was concerned that the vaccinations he had received may have contributed to his cardiac problems. MI was considered to be immediately life-threatening and an other important medical event (OMIC).  Other business partner numbers include E200303322 & 212869.  No further information is available.			Y	Y	Y				N	03/05/2003	09/01/2003	180	Cardiac catherization: see narrative; Cardiac pharmacological: see narrative; Chest x-ray: lungs mildly hyperinflated; Chest x-ray: mild prominence of infrahilar markings; Diagnostic lab: 11.85 NG/M, 08:15, MB confirmation high; Diagnostic microbiology: parasitology-neg for occult blood; ECG: see narrative;  Diagnostic lab: 19.36 NG/M, 14:54, MB confirmation; Anion gap: 9MMOL, low; Urine bilirubin test: negative; Total urine ketones: negative; Serum TnI: 5.87 NG/M, 07:16, critically high; Serum TnI: 15.42 NG/M; Serum Triglyceride: 192 mg/d, high; Serum LDL-C: 188 mg/d, high; Serum creatine kinase: 146 U/L, 07:16; Serum creatine kinase: 330 U/L, 14:54; Serum creatine kinase: 231 U/L, 08:15; Urine WBC count: 11.2 K/UL, high; Urine protein: negative; Urine nitrite: negative; Urine leukocyte: negative; Urine glucose: negative; Urine culture: <10,0 CFU/, urine contamination, >3 organisms isolated; Urine blood: negative, mono high at 1.2 K/UL; Serum calcium: 8.9 mg/d, low; Serum cholesterol: 255 mg/d, high; Serum CK-MB/total serum: 4.8, 08:15, high; Serum creatine kinase: 11.1 U/l, 08:15, high; Serum CK-MB/total serum: 5.2, 14:54; CBC: WNL except for MCH 31.8; CBC: WNL except for MCH 31.6;	OTH	OTH	ANA; Lipitor; Plavix; Imdur; Lopressor; Altace;	UNK	Migraine; Shoulder operation; Hyperlipidemia; Breath shortness; Osteoarthritis; Degenerative joint disease;		WAES0312USA02512	1						4	Chest pain; Dyspepsia; Dyspnoea; Laboratory test abnormal; Myocardial infarction; Laboratory test abnormal; Myocardial infarction; Chest pain; Myocardial infarction; Chest pain; Dyspepsia; Laboratory test abnormal; Myocardial infarction; Myocardial ischaemia	ANTH~EMERGENT BIOSOLUTIONS~Unknown~2~SC~LA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~Unknown~3~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~5377AA~1~~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~0980M~1~IM~UN~HEP A (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~UB269AA~1~SC~UN~MENINGOCOCCAL (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4020071~2~ID~LA~SMALLPOX (DRYVAX)~1|YF~UNKNOWN MANUFACTURER~UB358AA~1~SC~UN~YELLOW FEVER (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~3~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|MEN~SANOFI PASTEUR~UB269AA~1~SC~~MENINGOCOCCAL (MENOMUNE)~2|SMALL~PFIZER\WYETH~4020071~2~ID~LA~SMALLPOX (DRYVAX)~2|YF~SANOFI PASTEUR~UB358AA~1~SC~~YELLOW FEVER (YF-VAX)~2|ANTH~EMERGENT BIOSOLUTIONS~~2~SC~LA~ANTHRAX (BIOTHRAX)~3|FLUX~UNKNOWN MANUFACTURER~~3~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|HEP~UNKNOWN MANUFACTURER~5377AA~1~IM~UN~HEP B (NO BRAND NAME)~3|HEPA~MERCK & CO. INC.~0980M~1~IM~~HEP A (VAQTA)~3|MEN~SANOFI PASTEUR~UB269AA~1~SC~~MENINGOCOCCAL (MENOMUNE)~3|SMALL~PFIZER\WYETH~4020071~2~ID~LA~SMALLPOX (DRYVAX)~3|YF~SANOFI PASTEUR~UB358AA~1~SC~~YELLOW FEVER (YF-VAX)~3|ANTH~EMERGENT BIOSOLUTIONS~~2~SC~~ANTHRAX (BIOTHRAX)~4|FLUX~UNKNOWN MANUFACTURER~~3~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~4|HEP~MERCK & CO. INC.~~1~IM~~HEP B (RECOMBIVAX HB)~4|HEPA~MERCK & CO. INC.~0980M~1~IM~~HEP A (VAQTA)~4|MEN~SANOFI PASTEUR~~1~IM~~MENINGOCOCCAL (MENOMUNE)~4|SMALL~PFIZER\WYETH~~2~SC~~SMALLPOX (DRYVAX)~4|YF~SANOFI PASTEUR~~1~SC~~YELLOW FEVER (YF-VAX)~4	USA	Life Threatening,Hospitalisation	Influenza
0213232	12/31/2003	TX	10.0	10		F	11/24/2003	Reported to ER on Sat. 11/22 with symptoms of dizziness and unable to stand. School reported that on Fri. 11/21 the pt c/o feeling dizzy and c/o pain from a rash on her wrist. The hospital sent pt to another hospital.				Y					U	10/30/2003	11/21/2003	22	UNK	OTH	OTH	UNK	NONE	UNK		TX03151	1						2	Abasia; Anorexia; Asthenia; Headache; Laboratory test abnormal; Myalgia; Pain; Pharyngolaryngeal pain; Rash; Balance disorder; Dizziness; Rash	FLU3~SANOFI PASTEUR~U1092AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1092AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0214532	12/31/2003	SC	5.0	5		M	12/19/2003	Pt reacted to FluMist after it was given to him on 12/08/03. His mom said he started with runny nose and red rash all over his body. Pt came back into the office and treated with Zyrtec and Oraped.				Y					Y	12/08/2003	12/08/2003	0		PVT	PVT			NONE			1						1	Erythema; Rash; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500017P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0214534	12/31/2003	TX	4.0	4		F	12/10/2003	Itching in area of injection in left arm. Area also red, swollen and hot to the touch. Sx began in AM of 12/9/03 continuing today. No relief with Tylenol, Benadryl or cold packs to area. Seen by PMD. Dx: cellulitis. Being treated with Keflex.				Y					N	12/08/2003	12/09/2003	1		PUB	PUB	NONE	NONE	NONE		TX03153	1						1	Cellulitis; Injection site erythema; Injection site oedema; Injection site warmth; Pruritus	DTAP~SANOFI PASTEUR~U1007BA~UNK~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1092AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W1582~UNK~SC~RA~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0391N~UNK~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0214535	12/31/2003	CA	33.0	33		F	12/18/2003	Approx 2 hours after receiving vaccine, experienced dizziness, difficulty breathing, arm swelling, dry mouth, fever. Approx 5 hours after, chills, nausea, fever, tiredness. Approx 6 hours after, went to hospital ER. There for 4-5 hours, symptoms resolved. 24 hours after, continues feeling tired, no appetite. ER said they think it was a viral event.				Y					Y	12/15/2003	12/15/2003	0	Urinalysis	PUB	PUB	Singulair, Doxycyclin, Albuterol	NONE	Asthma		CA030139	1						1	Anorexia; Chills; Dizziness; Dry mouth; Dyspnoea; Fatigue; Nausea; Oedema peripheral; Pyrexia; Viral infection	FLU3~EVANS VACCINES~81454C~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214536	12/31/2003	TX	2.0	2	.4	F	12/09/2003	After receiving Fluzone first time, that afternoon started having fever, continued with fever for a day then got congested and 2 days later started coughing, also vomited. Required Albuterol treatments. Diagnosed with sinusitis and given Augmentin. Second, Fluzone, started vomiting and fever the following day, cough 3 days later. Congested since the following day, came into office diagnosed with cough and sinusitis.									Y	10/30/2003	10/30/2003	0	NONE	PVT	PVT	PRN Albuterol	NONE	Frequent sinusitis/wheezing			1						1	Cough; Nasal congestion; Pyrexia; Sinusitis; Vomiting	FLU3~SANOFI PASTEUR~U1128AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214537	12/31/2003	CA	5.0			M	10/29/2003	Urticaria, relieved by antihistamine.									Y					PVT	PVT		NONE	Medication allergies (pen, ceph)			1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0214538	12/31/2003	OH	74.0	74		M	12/26/2003	Red rash 24 hours after immunization. Swelling upper left arm after immunization.									Y	12/15/2003			NONE	UNK	UNK		NONE	NONE			1						1	Erythema; Oedema peripheral; Rash	FLU3~EVANS VACCINES~765886~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0865N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0214539	12/31/2003	LA	49.0	49		M	12/16/2003	Approx 2 minutes after injection, pt c/o dizziness, shortness of breath and palpitations. BP 230/88. HR 123, R 22, POx=98%. Pt became anxious, was transferred to hospital after 20 minutes. At ER pt given Benadryl, Lopressor, Ativan, Pepcid. Released 5-6 hours later.				Y					Y	12/11/2003	12/11/2003	0	EKG, lab work	OTH	PVT	NONE	NONE	NONE			1						1	Anxiety; Dizziness; Dyspnoea; Hypertension; Palpitations	FLU3~SANOFI PASTEUR~U1136AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214540	12/31/2003	OR	13.0	13		F	12/18/2003	Vaccine given at 6:30 PM, by 7:55 PM tight feeling in throat, tongue felt thick. Benadryl given with no progression of symptoms. Medical records confirm allergic reaction. msv				Y					Y	12/17/2003	12/17/2003	0		PVT	PVT		NONE	NONE			1						1	Hypersensitivity; Throat tightness; Tongue disorder	FLU3~SANOFI PASTEUR~U1093AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214541	12/31/2003	NY	33.0			F		No treatment, but I got really sick (flu). Got hives on neck, fever (103), arm was swollen for 7 days (hives for 2 days).									Y				NONE	PVT	OTH	Synthroid	NONE				1						1	Influenza like illness; Oedema peripheral; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0214547	12/31/2003	CO	5.0	5		F	12/18/2003	Left upper arm red and swollen and warm - approximately 6 area.									Y	12/09/2003	12/10/2003	1	NONE	UNK	UNK	NONE	NONE	NONE			1						1	Erythema; Feeling hot; Oedema peripheral	DTAP~SANOFI PASTEUR~U1007BA~5~~LA~DTAP (TRIPEDIA)~1|FLU3~EVANS VACCINES~814600~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~W1002~4~~LA~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~1013M~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0214550	12/31/2003	CA	33.0			M	12/25/2003	FluMist given 12/15, developed fever to 102 with headache, sore throat, cough on 12/16-12/19.  Chest pain-pleuritic 12/20.  Physical exam: HR: 121; Temperature 98; Lungs clear.				Y					U				EKG: WNL	OTH	OTH	NONE	NONE	Snoring			1						1	Chest pain; Cough; Headache; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0214570	12/31/2003	CA		11		F	12/29/2003	Cough, fever of 104 within 24 hours of vaccine.									U	12/20/2003	12/21/2003	1		PVT	PVT		NONE	Allergies; Asthma			1						1	Cough; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500042P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0214587	12/31/2003	VA	24.0	24		F	12/31/2003	PATIENT ATTEMPTING TO CONCEIVE AT TIME OF VACCINE, NOTIFIED ADMINISTERING STAFF, VACCINE GIVEN REGARDLESS.  PATIENT DID CONCEIVE AND IS NOW 12 2/7 WEEKS PREGNANT.									U	10/15/2003				MIL	UNK						1						1	Unintended pregnancy	ANTH~MICHIGAN DEPT PUB HLTH~~4~IM~RA~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0214578	01/02/2004	OH	33.0	33		F	12/16/2003	Developed cellulitis at site of injection following flu vaccine.									Y	12/09/2003	12/10/2003	1	NONE	PVT	PVT						1						1	Cellulitis; Injection site reaction	FLU3~SANOFI PASTEUR~U1124AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214579	01/02/2004	MS	10.0	10		M	12/26/2003	Right shoulder red and swollen about 12 cm area.									Y	11/04/2003	11/05/2003	1	NONE	PVT	PUB	Biaxin; Palgic	Pneumonia				1						1	Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~U1271AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0710M~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0214580	01/02/2004	VA	59.0	58		F	12/22/2003	Patient informed our flu nurse while she was conducting a clinic this year that she had had a severe reaction to last years flu shot. Here is her report: Received flu shot on 11/1/02 in her left arm. Monday, 11/4/02, started experiencing tingling and burning around where she received the shot; this moved down her entire arm. Within the next 2-4 days the tingling moved to her left leg. Had no motor deficits in either the arm or the leg. At this point, she saw her private GP and was eventually referred to a neurologist. The neurologist initially didn't feel it was due to the flu shot, but after attending a conference changed her mind and told her that several other neurologists had noted similar post-flu shot reactions with almost immediate neurological manifestations. Underwent testing; was told there was no nerve damage and the tingling was probably indicative of damage to the myelin sheath and would eventually get better. In March was placed on steroids (10 day course); by April was better, although she was told the episodes might recur. Has since had 2 recurrences, although not as bad as the initial episode--these were focused in her left shoulder and upper arm (not her leg), and consisted of a cold feeling and some tingling. The most recent of these was just several weeks ago (late November 2003). Both of these episodes resolved without treatment after several weeks.				Y					U	11/01/2002	11/04/2002	3	UNK	OTH	PVT	UNK	NONE	UNK			1						1	Feeling cold; Paraesthesia; Thermal burn	FLU3~SANOFI PASTEUR~U0988BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214635	01/04/2004	WV	48.0	48		F	01/04/2004	Dizziness, difficulty breathing, increase in pulse, increase in blood pressure.  Within 5 minutes of shot.									Y	11/04/2003	11/04/2003	0		UNK	PUB	none	none	none			1						1	Blood pressure increased; Dizziness; Dyspnoea; Heart rate increased	FLUX~UNKNOWN MANUFACTURER~unknown~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213810	01/05/2004	MI	27.0	27		F	11/14/2003	Telephone call received 11/14/03, pt states that within 12 hours of receiving flu shot on 10/22/03 she awoke feeling like her throat was closing. Seen in the ER. Stated the feeling lasted 4 hours during which she was given epinephrine, Benadryl and Tagamet. Stated she stayed on Benadryl for 24 hours past discharge. Stated symptoms of feeling her throat was closing off starting again when she stopped taking Benadryl. Pt remains on Chlortrimetron and Albuterol inhaler and states she continues to experience slight throat closure, wheezing and SOB to date. Pt asked PHN if neomycin was in the vaccine and PHN informed her it is prepared with neomycin as stated by telephone call to manufacturer Evans.				Y					N	10/22/2003	10/23/2003	1	NONE	PUB	PUB	NONE	NONE	Allergies to mycins, penicillin, tetracycline, cephalosporin, sulfa, bee stings, molds. Pt states she has developed a reaction to mycins with throat closure and body rash. Medical history includes atrial septal defect, pulmonary valve stenosis, endometriosis, seizure disorder from age 14-19, not on meds presently.		MI2003066	1						2	Dyspnoea; Throat tightness; Wheezing	FLU3~EVANS VACCINES~765852~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0214598	01/05/2004	CA	60.0			M	12/23/2003	C/E after flu shot: paresthesias, numbness, inability to walk. Onset of Guillain-Barre 1 day after administration of flu shot. Transferred to ICU and IVIG administered for 2 days. Patient improved.					Y				U	11/15/2003	11/26/2003	11		UNK	UNK			COPD; Chronic A fib; CAD; Status post coronary artery bypass; Renal insufficiency;			1						1	Difficulty in walking; Guillain-Barre syndrome; Hypoaesthesia; Paraesthesia; Guillain-Barre syndrome	FLU3~EVANS VACCINES~765795~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0214599	01/05/2004	MA	41.0			F	12/26/2003	Pt developed varicella type CNS infections 2 weeks post influenza vaccine. This is 12th pt admitted with shingles or similar type infection 2 weeks after vaccine.					Y				U	12/09/2003	12/23/2003	14		UNK	UNK						1						1	Herpes zoster; Viral infection	FLU3~SANOFI PASTEUR~U1145AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0214602	01/05/2004	CA	22.0	21		F	01/02/2004	ADEM. The discharge summary received on 1/12/03 states viral meningitis; decreased oral intake; headache; difficulty ambulating; UTI; urinary retention; anxiety; hyperglycemia; thrombocytopenia and coagulopathy. The neuro consult received on 1/12/04 states myalgia, diplopia, vergigo, fever, nausea/vomiting, nystagmus, 6th nerve palsy, and tremulous.  60-day follow up on 03/24/04: It is unknown if pt recovered from adverse events.			Y		Y	14		Y	U	12/01/2003	12/16/2003	15	LP; MRI; abnormal CSF	PVT	PVT		Urinary Tract infection treated with ciprofloxacin	H/O periodic weakness r/o multiple sclerosis (doubted); asthma			1						1	Anxiety; CSF test abnormal; Coagulopathy; Diplopia; Encephalitis; Gait disturbance; Headache; Hyperglycaemia; Meningitis; Myalgia; Nausea; Nystagmus; Paralysis; Pyrexia; Tremor; Urinary tract infection; Vertigo; Vomiting	FLU3~SANOFI PASTEUR~U1172AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0214605	01/05/2004	MI	41.0	41		F	12/08/2003	Pt states 2-3 hours after receiving vaccine left arm deltoid area became red, swollen and hot to touch. Swelling and redness increased on Friday. Minimal soreness. By Mon. 12/8 redness, swelling and soreness subsided.									Y	12/04/2003	12/04/2003	0		PUB	PVT	NONE	NONE	NONE		MI2003067	1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~1293AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214606	01/05/2004	MI	1.92	1	1	F	12/10/2003	Mother reports child woke up this morning about 8:30 AM with red rash hives on legs, arms and face. Mother gave child 1 tsp Benadryl and is waiting for doctor's office to open at 10 AM. Mother called PP and was instructed to stay on Benadryl dosing. If child worsened then to see PP. 12/15/03 child's hives resolved in 24 hours. Did not see PP. But has well child appt in 1 week and will ask PP if second dose of flu is recommended.									Y	12/05/2003	12/10/2003	5	NONE	PUB	PUB	NONE	NONE	NONE (eats egg/egg products without problem)		MI2003068	1						1	Erythema; Urticaria	FLU3~SANOFI PASTEUR~U1108AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214607	01/05/2004	CA	75.0	75		F	12/19/2003	Swelling of upper arm left hot and red. Chills, aching all over body, muscle soreness.									Y	12/18/2003	12/18/2003	0		PUB	OTH		NONE				1						1	Chills; Feeling hot; Injection site erythema; Injection site warmth; Myalgia; Oedema peripheral; Pain	FLU3~EVANS VACCINES~766048~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0256N~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0214608	01/05/2004	LA	4.0	4		M	11/23/2003	Friday afternoon 11/21/03 Mom noted whole top of left arm was red, hard, hot and swollen, area was about size of pear. No fever, no pain. Mom called MD Sat AM and was counseled to give Benadryl every 4 hours. Vomited Sunday x3, swelling and redness much improved by Sunday. None noted Monday, only small area hard around injection site.									Y	11/20/2003	11/21/2003	1		PUB	PUB	NONE	NONE	NONE		CA031203	1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site warmth; Vomiting	DTAP~SANOFI PASTEUR~U0996DA~5~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1094AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1009M~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0214609	01/05/2004	MD	13.0			M	12/18/2003	Information regarding FluMist (2002-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding her 13 year old male child who received a dose on 12/08/2003.  A consumer reported that her 13 year old male child developed a slight, minor headache (headache) about 15 minutes after receiving FluMist.  Headache resolved without treatment approximately 2 hours later.  No additional information was available at the time of this report.									Y	12/08/2003	12/08/2003	0	UNK	PVT	OTH	UNK	UNK	UNK		HQWYE573512DEC03	1						1	Headache	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0214610	01/05/2004	CA	51.0	51		U		Cold, cough, fever, aches, headache, fatigue (next day). Went into severe bronchial infection within days.				Y					Y	10/02/2003	10/03/2003	1		OTH	PVT	Depakote, Prilosec	NONE	Hay fever to grasses			1						1	Cough; Fatigue; Feeling cold; Headache; Pain; Respiratory tract infection	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0214611	01/05/2004	MD	71.0	71		M	11/07/2003	10/28/03: 11 AM flu shot. 10/29/03: 8 AM weakness, nausea, near syncopy. 10/29/03 9 AM 2nd bout of above, BP 60/40. 10/29/03: 9:15: ambulance to ER, O2, chills. 10/29/03: 11 PM: temp 101 degrees F., chills, elevated white cell count. IV saline. 11/30/03: 9 AM: temp, BP normal.				Y	Y	2			Y	10/28/2003	10/29/2003	1	Chest X-ray, chemistry.	PUB	PUB	Lipitor, Topril, aspirin, Plaxix	NONE	CAD, heart condition, cancer			1						1	Asthenia; Blood pressure decreased; Chills; Nausea; Pyrexia; Syncope; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0214612	01/05/2004	NY	45.0	45		M	12/23/2003	Approx 3 weeks after receiving flu vaccine, pt began to experience numbness and tingling in hands and feet with lack of reflex response in arms and legs. Has seen MD 3 times in last month and due to revisit this week. Still experiencing tingling/numbness and also heaviness in arms in legs. MD suspects Guiallan-Barre Syndrome. Still experiencing symptoms. The medical records received on 1/9/04 states weakness and fatigue.   Nurse follow up on 06/28/04 states: ADD: Osteopenia.				Y					N	11/06/2003	11/25/2003	19	EMG abn;	PUB	PVT	Enalapril	NONE	In remission from leukemia, myelodysplasia, impaired balance, decreased coordination, neurotoxic reaction.			1						1	Asthenia; Bone disorder; Guillain-Barre syndrome; Hypoaesthesia; Hyporeflexia; Laboratory test abnormal; Paraesthesia; Sensation of heaviness	FLU3~SANOFI PASTEUR~U1268AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214613	01/05/2004	TX	13.0	13		M	12/16/2003	Per mother, on 2nd day of pneumococcal vaccine administration, pt had redness and swelling to right deltoid area and had a low grade fever, did not measure temp increase, and slight pain to arm. On 3rd day of vaccine administration, 12/11/03, swelling and redness diminishing and fever resolved, no more pain to left deltoid area. Used warm compresses as instructed on day of vaccination.									Y	12/09/2003	12/10/2003	1		PUB	OTH	Anti-depressant, folic acid, Nexium, Vioxx, Plendil, Methatrexate	Raynaud's disease - mixed connective tissue	Mixed connective tissue - Raynaud's disease, NKA		TX03159	1						1	Injection site erythema; Injection site oedema; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1091AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0257N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0214614	01/05/2004	TX	34.0	34		F	12/15/2003	12/10: called day after vaccination c/o pain to right deltoid radiating to shoulder and neck. 12/11: called c/o swelling to both hands and joint pain. 12/15: continues to c/o joint pain.									U	12/09/2003	12/10/2003	1	NONE	PUB	PUB	NONE	NONE	Arthritis		TX03158	1						1	Arthralgia; Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~U1092AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U0527AA~2~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0214615	01/05/2004	MI	80.0	80		M	12/29/2003	Pt experienced stomach cramps, dizziness for 3 days. No neurological, musculoskeletal side effects. After receiving influenza vaccine, lot #U1268AA. Had stomach cramps, dizziness for three days. No neurological/musculoskeletal side effects. At the time, the vaccine was under investigation and held for immunizations. Patient was doing OK afterwards. No sequelae. No allergy.									Y	10/14/2003	10/17/2003	3	NONE	PVT	OTH	NONE	NONE	Allergic rhinitis; Diabetes Mellutis			1						1	Abdominal pain; Dizziness	FLU3~SANOFI PASTEUR~U1268AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214636	01/05/2004	KS	22.0	22		F	12/29/2003	Pt given FluMist intranasally. She had no URI or illness symptoms preceding and temp=98.2. 10-15 minutes later she developed mild substernal pressure/tightness that persisted for about 1 hour and 20 minutes. She was given ibuprofen 800mg and Zyrtec 10mg 15 minutes before resolved. No recurrence and didn't go on to infectious symptoms.									Y	12/17/2003	12/17/2003	0		OTH	PVT	Orthotricyclen	NONE	red dye			1						1	Chest pain	FLUN3~MEDIMMUNE VACCINES, INC.~500033P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0214673	01/05/2004	TX	0.5	0	.5	F	01/05/2004	Patient was given immunizations on Monday, Dec 29.  She presented to the office 5 days later with poor feeding and increased sleepiness.  She appeared very pale and had an H/H of 4.1/12.4.  She was diagnosed with autoimmune hemolytic anemia and admited to hospital for transfusions.			Y	Y	Y				U	12/29/2003	01/01/2004	3	Hgb 4.1, Hct 12.4, MCV 87, RDW 21.7, retic 6.7 Smear reviewed by hemotologist.	PVT	PVT	none	no	no			1						1	Anaemia haemolytic autoimmune; Laboratory test abnormal; Oral intake reduced; Pallor; Somnolence	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~21919C2~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~EVANS VACCINES~765979~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HIBV~SANOFI PASTEUR~UE082AA~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~495883~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Life Threatening,Hospitalisation	Influenza
0214674	01/05/2004	VA	73.0	73		F	01/05/2004	Persistent pain in left arm and shoulder at site of injection									U	12/30/2003	12/31/2003	1		MIL	MIL		none	Hypothyroid, Irritable Bowel Synd., osteoarthritis			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U1172AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214539	01/06/2004	LA	49.0	49		M	12/26/2003	From initial information received on 12/22/03 from the vaccine administrator, regarding an adverse event occurring in the USA, it was reported that a 49 year old male patient received a first dose of FLUZONE SV, lot number U1136AA, administered IM in the left deltoid on 12/11/03 at 1:00 PM. Approximately two minutes later, the patient complained of dizziness, shortness of breath, and palpitations. His blood pressure was 230/88, heart rate 123, respirations 22, and pulse oxygenation level 98%. The patient became anxious and was transferred to the hospital after 20 minutes. At the emergency room, the patient was given Benadryl IV, Lopressor, Ativan and Pepcid. The patient was released five to six hours later. The patient reportedly recovered from this event on an unspecified date. (OMIC) Additional communication was received on 1/29/04 fro a health care professional, who reported that no additional information is available at this time. Follow up 01/06/05: Medical Assessment: In the absence of another etiology, the hypothesis of an allergic like reaction could be evoked. However, there were no allerty testins reported in order to identify a potential sensitzation to one of the vaccine components.				Y					Y	12/11/2003	12/11/2003	0	EKG and other lab work (unspecified) were done. No results provided.	OTH	PVT		NONE	NONE		200303605	1						2	Anxiety; Blood pressure increased; Dizziness; Dyspnoea; Heart rate increased; Palpitations	FLU3~SANOFI PASTEUR~U1136AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0214640	01/06/2004	PA	74.0	73		F	12/26/2003	This subject is a 74 year old female, who died while enrolled in a comparative randomized study of safety and immunogenicity of a non-adjuvanted respiratory syncytial virus vaccine versus an RSV vaccine adjuvanted with Aluminum Phosphate when administered concomitantly with a Licensed Influenza vaccine in High-Risk > or = 65 years of age. The subject received a dose of RSV vaccine or placebo and influenza vaccine on 9/30/02. The subject died, 444 days post-immunization. The cause of death was not reported. The patient's has a history of lung mass, dyspnea, pleural effusion, smoking, asthma, and COPD. The death was reported by the investigator as unrelated to the study vaccine. THe death certificate received on 2/3/04 states metastatic lung CA. The medical record received on 2/9/04 states pain, anorexia, blood oxygen decreased, decreased mobility, respiratory distress, weakness, hemoptysis, and chest pain. Additional information received January 12, 2004 death certificate cause of death: metastic lung cancer.	Y	12/18/2003							N	09/30/2002	12/18/2003	444		UNK	UNK	RSV/Placebo		Lung mass, dyspnea, pleural effusion, + smoker, asthma, COPD.		200303616	1						1	Anorexia; Asthenia; Chest pain; Dyspnoea; Haemoptysis; Hypokinesia; Hypoxia; Lung neoplasm malignant; Pain; Skin disorder	FLU3~SANOFI PASTEUR~U11374A~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0214652	01/06/2004	NC	5.0	5		F	12/15/2003	Pt started with temp of 102 approx 2 1/2 hours after administration of influenza vaccine. Temp up to 105 the following day.				Y					Y	12/11/2003	12/11/2003	0	NONE	PVT	PVT	NONE	c/o itchy throat, exam normal	NONE		NC04002	1						1	Pyrexia	FLU3~SANOFI PASTEUR~U1148DA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214653	01/06/2004	MN	68.0	68		M	12/05/2003	10/28/03: Awoke with swollen mouth, lip, cheek on right side. Later that day swollen, raised white areas from 1 diameter to 6 diameter over entire body. When they turned red they itched. Other lip followed. This continued 1 month. Now 6 weeks later still raised areas over body that come and go. Tx Benadryl. No decrease in severity.									N	10/27/2003	10/28/2003	1	Observed by 2 doctors.	PUB	UNK	Sinimet, Requip, Clonazepam, Lisinopril	NONE	Parkinsons		MN03009	1						1	Face oedema; Oedema; Pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~U1267AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214654	01/06/2004	MN	83.0	83		M		Right arm weakness since flu shot given on 10/23/2003. Follow up 1/19/04: Follow up visits with patient are much more consistent with rotator cuff pathology as the etiology of his shoulder paina nd weakness than his initial assertion that it was due to his flu shot.									N	10/23/2003	10/25/2003	2		PVT	UNK						1						1	Hemiparesis	FLU3~EVANS VACCINES~965501~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214655	01/06/2004	NY	48.0	48		F	11/06/2003	AM of 10/30/03 noted that injection site was very sore, hot to touch and swelling 7cm x 5cm. 5 days before swelling and soreness resolved.									Y	10/24/2003	10/30/2003	6	NONE	PVT	PVT		NONE	Sulfa - Macrodantin, metals except gold, bee stings, adhesive tape, tetanus local reaction.	Severe local reaction 30 days~Tetanus Toxoid (no brand name)~3~18.00~In Patient		1						1	Injection site oedema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U1269AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214656	01/06/2004	MN	45.0	45		F	12/22/2003	Ache in left humerus. Left 4th ring finger numb and weak. Left arm numb and weak. It began about 2 weeks post shot. Shot given 11/12/2003.				Y					U	11/12/2003	11/26/2003	14	Normal C-spine MRI 12/19/03. Saw neurologist 12/22/03.	PVT	PVT		NONE	NONE			1						1	Hypoaesthesia; Muscular weakness; Pain	FLU3~SANOFI PASTEUR~U1146BA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214657	01/06/2004	CA	10.0	10		M	12/24/2003	6 x 8cm erythematous induration right upper arm at site of immunization.									U	12/16/2003	12/17/2003	1		PVT	OTH						1						1	Injection site erythema; Injection site induration	FLU3~EVANS VACCINES~766050~2~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0863N~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0214659	01/06/2004	TX	76.0	76		F	10/20/2003	Vaccine caused bad swelling in arm and knot in muscle. Affected joints, shoulder, knees, back. Took one month to recover.									Y	10/20/2003	10/21/2003	1		PUB	OTH			Tartrazine (dyes), asthma, high blood pressure, osteo			1						1	Arthralgia; Musculoskeletal discomfort; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0214676	01/06/2004	GA	7.0	7		F	01/06/2004	Within 2-3 hours of receiving flu mist vaccine pt erupted with an exanthematous light pink rash covering the lower torso and legs - not pruritic or urticarial. Mostly resembles a viral exanthem.									U	01/05/2004	01/05/2004	0	none indicated	PVT	UNK	none	NONE	none			1						1	Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500041P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0214697	01/06/2004	SC	78.0	78		F	01/06/2004	That evening (10/28/03) broke out in erythematous rash all over body.  Denied any tongue swelling or difficulty breathing.  Required IV steroids and Atarax at ER.  Is on a prescription for steroids orally (tapering dose.  Currently with minimal rash left 10/30/03.  report made by her PMD.				Y					Y	10/28/2003	10/28/2003	0	NONE	PUB	PUB	Unknown	NONE	None		SC0353	1						1	Rash erythematous	FLU3~SANOFI PASTEUR~U1260AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214701	01/06/2004	SC	4.0	4		M	01/06/2004	15 minutes after receiving MMR and influenza vaccine, fell suddenly to the floor while watching sister receiving a vaccine. Noted bruising and small laceration over right ear.  Child was crying and stated his head hurt.  BP=80/60; Pulse=100; R=20.  EMS transported child to ER. Report will follow.				Y					Y	11/26/2003	11/26/2003	0	NONE	PUB	PUB	NONE	NONE	NONE		SC0354	1						1	Blood pressure decreased; Contusion; Crying; Heart rate increased; Injury; Loss of consciousness	FLU3~SANOFI PASTEUR~U1291AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0060N~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0214703	01/06/2004	SC	2.0	2	.1	M	01/06/2004	Developed hives on face and back within 10 minuters of vaccine administration. Patient remained alert and talkative.  No respiratory symptoms.  Hives diminished within 20 minutes. No other symptoms or complaints.									Y	12/03/2003	12/03/2003	0		PUB	PUB	NONE	NONE	NONE		SC0355	1						1	Urticaria	FLU3~SANOFI PASTEUR~U1291AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214680	01/07/2004	OH	13.0	13		F	11/07/2003	Right arm swollen, tender, decreased movement secondary to pain. No redness, no warmth, no decreased sensation, NL radial and ulnar pulse, no discolor. Tx: ice, elevation x1 day, then movement.									U	11/05/2003	11/06/2003	1	NONE	PUB	UNK	Albuterol, Singulair Flovent	Tinea versicolor	Asthma, tinea versicolor			1						1	Joint range of motion decreased; Oedema peripheral; Pain	FLU3~EVANS VACCINES~765756~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~SANOFI PASTEUR~U1011AA~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0214681	01/07/2004	KS	7.0	7		F	01/06/2004	Pt was administered flu vaccination when fainted, fell to floor, airway patent, became alert within 30 seconds, pallor, P-108, weakness, swollen area on back of head after fainting. Observed for 40 minutes, took fluids, alert and oriented. Sent via EMS to ER for further evaluation.				Y					U	01/05/2004	01/05/2004	0	NONE known	PUB	PUB	NONE	NONE	NONE.  Did have a #1 flu vaccine on 12/05/03 1st time recipient.			1						1	Asthenia; Fall; Oedema; Pallor; Syncope; Asthenia; Chest pain; Coma; Contusion; Fall; Heart rate increased; Nausea; Pallor; Syncope	FLU3~EVANS VACCINES~765878~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~EVANS VACCINES~765878~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0214682	01/07/2004	CA	14.0	14		F	12/22/2003	Rash, severe itching. ER 12.				Y					U	10/22/2003	10/24/2003	2		PVT	OTH	Allegra; Advair; Flonase;	NONE	Asthma; Hayfever			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U1139AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214683	01/07/2004	NY	39.0	39		F	11/06/2003	10 hours after receiving vaccine, began to experience severe leg pain bilaterally. Pain increased over next 3 hours and remained constant for 2 days followed by 2 days of lesser amount of leg pain. Also at 12 hours began to experience generalized weakness and aches to entire body with temperature of 99.9. All symptoms unrelieved with Motrin or Tylenol.									Y	10/29/2003	10/30/2003	1	NONE	PVT	PVT	Zoloft, multivitamins, calcium with D	NONE	NONE	3 day temp paralysis~Vaccine not specified (no brand name)~~3.00~In Patient		1						1	Asthenia; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1269AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214684	01/07/2004	CA	1.83	1	.9	M	12/29/2003	+ urticaria (diffuse) within 24 hours. No hx egg allergy.				Y					Y	12/12/2003	12/13/2003	1		PVT	PVT	NONE	NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1073AB~UNK~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214707	01/07/2004	FL	45.0			F	01/07/2004	Symptoms experienced one day after receiving the vaccine: swelling on the left side of the neck that lasted 4-5 days, and lethargy that lasted 2-3 days.									Y	12/15/2003	12/16/2003	1	Flu vaccine administered: FLUVIRAL S/F (2003-2004) Manufactured by Shire Biologics, Lot # 3FV17711, Exp. AU2004.	UNK	UNK						1						1	Lethargy; Oedema	FLUX~UNKNOWN MANUFACTURER~3FV17711~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0214708	01/07/2004	NJ	14.0	14		M	12/30/2003	This case was considered medically important (OMIC). Information regarding Flumist was received from a pediatrician regarding a 14 year old male pt who experienced acute disseminated encephalomyelitis. At 14 years of age, the pt received a dose on 12/19/03. The pt's concurrent illness includes asthma. Indication for Flumist was immunization. Product was administered on 12/19/03. Dose regimen was one dose. Pt was not taking concomitant therapy. On 12/21/03, 2 days post-immunization, the pt experienced acute disseminated encephalomyelitis. No additional info was available at the time of this report. Follow-up information obtained via telephone from the physian provided specific symptoms, diagnostic tests performed, treatment and event outcome (patient recovered). Information regarding Flumist (2003-2004 formula) (influenza virus vaccine, live intranasal solution (frozen) was received from a pediatrician regarding a 14-year old male patient who experienced acute disseminated encephalomyelitis. Medical History: The patient's concurrent illness includes mild excercised induced asthma. He presented with slight upper respiratory infection symptoms on day of vaccination but was essentially well. On 21-Dec-2003, 2 days post-immunization, the patient presented to the emergency room with confusion and uphasis. He was transferred to a nearby hospital and admitted to the pediatric intensive care unit. On 22-Dec-2003, he had hyperrflexia, eloqua, meningisma and confusion on exam. An MRI of the head revealed a diagnosis of acute disseminated ancephalomyelitis. He was treated with steroide (not specified) and improved dramatically within 24 hours. On 29-Dec-2003, the patient was discharged from the hospital. He was seen for follow-up on 06-Jan-2004, and was completely recovered. Of note, the patient's sister was diagnosed with acute disseminated encephalomyelitis after a viral infection in March 2000.									Y	12/19/2003	12/21/2003	2	In Dec-2003 test results were lumbar punture (results unspecified), nuclear magnetic resonance imaging (results revealed a diagnosis of acute disseminated encephalomyelitis), mycoplasma antibody (results: Mycoplasma titer was low positive), and viral test (results, nasal swabs for Influenza A & B were negative).	OTH	OTH	NONE	UNK	Asthma. Medical History: The patient's concurrent illness includes mild excercised induced asthma. He presented with slight upper repiratory infection symptoms on day of vaccination but was essentially well		HQWYE901524DEC03	1						1	Confusional state; Encephalitis; Hyperreflexia; Medication error; Meningism	FLUN3~MEDIMMUNE VACCINES, INC.~500034P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0214709	01/07/2004	GA	6.0	6		M	12/31/2003	A mother reported that her 6 year old son received a dose of Flumist on 12/12/03 and developed a cough and wheezing. The pt's concurrent medical history includes reactive airway disease and a tendency to wheeze with any upper respiratory illness. Past medical history includes respiratory syncytial virus at 4 months of age and pneumonia. The pt received an intranasal dose of FLuMist on 12/12/03. Indication was immunization. Concomitant medication included unspecified vitamins. No other vaccines were administered on the day the pt received the FLuMist vaccine. On 12/12/03, the child developed coughing after the administration of FluMist. The reporter indicated that the coughing became deeper and on 12/15/03, the child developed wheezing. On 12/16/03, the child was seen by a physician and was prescribed Zithromas. As of 12/22/03, the coughing and the wheezing had subsided. This event was considered medically important (OMIC). No additional info was available at the time of this report.				Y					U	12/12/2003	12/15/2003	3	UNK	OTH	OTH	Vitamins	UNK	Bronchospasm; pneumonia; respiraotry syncytial virus; wheezing		HQWYE890823DEC03	1						1	Cough; Medication error; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0214710	01/07/2004	CA	39.0			M	05/20/2004	Dehydration was considered medically important (OMIC). A nurse reported that a 39 year old male received Flumist and developed a fever, aches, pains, cough, dehydration, sore throat, headaches and nausea. The pt was reportedly healthy. Indication for Flumist was immunization. Product was administrated on 12/18/03. Dose regimen was 0.5mL. Concomitant medications were not reported. On 12/21/03, the pt, while staying at a ski resort, developed upper respiratory tract infection (URI) symptoms including fever, aches, pains, cough, dehydration, sore throat, headaches and nausea. Treatment at a local medical facility included IV fluids for a few hours for the dehydration and ibuprofen for the aches and pains. The reporter stated that the pt had to be shipped home because he was so sick. Follow up: information from the nurse revealed that the patient was seen at the clinic one time for URI symptoms. A nurse reported that a 39-year old male received Flumist and developed a fever, aches and pains, dehydration, sore throat, headaches, nausea, cough and upper respiratory tract infection symptoms. The patient received a dose on 18DEC2003.				Y					U	12/18/2003	12/21/2003	3	UNK	OTH	OTH	UNK	NONE	UNK		HQWYE901424DEC03	1						1	Cough; Dehydration; Headache; Nausea; Pain; Pharyngolaryngeal pain; Pyrexia; Upper respiratory tract infection	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0214712	01/07/2004	MD	11.0	11		M	01/07/2004	Patient developed Croup 3 days following Flu Mist vaccine and required an Emergency room visit due to stridor and a course of Prednisone				Y					Y	12/15/2003	12/18/2003	3	Croup Lab tests do not document croup, dyspnea, cough. msv	UNK	UNK		None	Medical records state Hx of croup. msv			1						1	Cough; Dyspnoea; Laryngitis	FLUN3~MEDIMMUNE VACCINES, INC.~500033T~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0214731	01/07/2004	VA	31.0	31		M	01/07/2004	Developed flu-like symptoms, including headache within 24 hours of receipt of vaccine. On day 2 post vaccination developed blurred vision and increasing cephalgia. On day 4 post vaccination developed diplopia and sixth cranial nerve palsy.  Nurse follow up on 06/28/04 states: ADD: photophobia, eyes aching, bilateral perceptual decompensation, esotropia, Immune mediated response to vax, fatigue, insomnia, falling.				Y					N	11/25/2003	11/26/2003	1	CT 5 days post vaccination was normal; MRI with and without contrast on day 9 revealed  Bilateral supratentorial cerebral periventricular and subcortical white matter scattered roundish 2-3mm increased T2 signals without enhancement, T1 signal change, or mass effect noted. CSF from spinal tap was normal.	MIL	MIL	None	None	left Maxillary sinus disease Medical records state cyst.			1						1	Diplopia; Eye disorder; Eye pain; Fatigue; Headache; Hypersensitivity; Influenza like illness; Injury; Insomnia; Laboratory test abnormal; Paralysis; Photophobia; Vision blurred; Visual field defect	FLUX~UNKNOWN MANUFACTURER~~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0214733	01/07/2004	NJ	74.0	74		F	01/07/2004	Patient received Pneumonia Vaccine on I/2/04 at 4:20 PM. It was given in her right lateral thigh. At the same time she rec'd a flu injection in her  R arm.  Her other arm was not available for an injection due to previous surgery.   She called on 1/5 stating At 8 PM on 1/2/04, Friday night, my right knee and lower leg started to hurt.  It was red and started to swell.  I kept hoping it would go away. Patient was seen on 1/5/04 by a doctor and a registered nurse. On 1/5 redness and warmth were noted about an inch above the kneecap and around the back of the knee and down the lower leg a few inches in front. There was no redness at the injection site at midthigh. Cellulitis was diagnosed.				Y					Y	01/02/2004	01/02/2004	0		MIL	PUB		Temperature was 98.9 at time of vaccination.	No allergies H/O heart disease			1						1	Cellulitis; Erythema; Feeling hot; Pain; Swelling	FLU3~EVANS VACCINES~765883~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1200N~1~IM~RL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0214734	01/07/2004	MN	49.0	48		F	01/07/2004	about 72 hours after flu shot, pt awoke with mild headache and body aches. Headache pain intensified to the 'worst headache ever' over the next 48 hours. Pt went to ER, CT and Spinal Tap normal. Treated with morphine and released. various treatments, hospitalization and tests (MRI, MRA and ep blood patch (x2)) no relief.  8 weeks later, still experiencing headaches from inflamed menins and w/associated low csf pressure. Medical records state weakness. msv				Y	Y	7			N	11/10/2003	11/13/2003	3	MRI, MRA, Mri with contrast, Spinal culture (x2) blood work, Blood patch (x2),CSF abnormal	UNK	UNK	TRAZADONE 50mg bedtime	none	Had flu shot in conjunction with physical. Good health, no know problems. Follow-up information indicates the pt suffered from stress and depression. Medical records state viral infection.			1						1	Asthenia; CSF test abnormal; Headache; Meningism; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0213835	01/08/2004	LA	40.0	40		F	01/02/2004	Information has been received from a physician concerning a 40 year old white female with an allergy to acetaminophen (+) codeine phosphate, depression, irritable bowel syndrome, possible bronchitis, and gastroesophageal reflux disease who on 11/17/03 was vaccinated IM in the arm with a dose of pneumococcal 23v polysaccharide (lot # 645249/1196M). Concomitant vaccination on the same day included an IM dose in the arm of influenza virus vaccine (lot # 765703). Illness at the time of vaccination included peptic ulcer disease. The physician reported that after vaccination the patient developed redness, warmth, and pain at the injection site. The pain has continued to the present. The patient was treated and released from her local emergency room where she was placed on prednisone. A product quality complaint was not involved. Follow up information was received from the physician which indicated that on 11/17/03 the patient had a decreased appetite, little chest pain, abdominal pain above the belly button, and a minimal rash on right. The patient was in the emergency room and got morphine and acetaminophen (+) hydrocodone bitartrate for a pain in muscle. A sedimentation rate was elevated and a white blood cell count was normal. On 11/24/03 an abdominal ultrasound result indicated that the liver, pancreas, kidneys, gallbladder, and spleen appeared normal. The impression was a normal abdominal ultrasound and the patient was noted to have a small left sided pleural effusion. It was noted that the patient was hospitalized and at the time of the report, had not recovered. See lab section for all other lab results. Information was received on 12/23/03 which pertained to an event which occurred approximately seven days after vaccination with pneumococcal 23v polysaccharide vaccine. This information contained the following adverse experience: small left sided pleural effusion (approximately (11/24/03). Additional information has been requested. Follow up information received on 01DEC2003 from the patient indicated that she went back into the hospital on 25NOV2003. She reported that she was admitted for excruciating pain at the site of injection and that the swelling is still 3 inches in diameter at the vaccination site. Additional follow up information received from a registered nurse on 11FEB2004 indicated that on 06FEB2004, the pt reported t her that her arm was stillsore and theat she was having tingling in her fingers. The nurse also reported that the pt has not been seen in the office for awhile and reports that she cannot come into the office because she can not afford to be seen. Medical records will follow. Additional follow up information was received from medical records. It was noted that the patient said that the doctors said she might have a staph infection. On 18NOV2003, the pt presented because she had a pneuonia shot and had a bad raction. At this time, she had a somewhat productive cough, sinus congestion and drainage, fatigue, little appetite, little chest pain, abdominal pain above the belly button, and shortness of breath. The plan was ibuprofen 800 mg, ice and follow up in one week. On 19NOV2003, it was noted that the pt was in the emergency room. No fever was noted and the pt received morphine and antibiotics. On 23NOV2003, a chest x-ray showed no infiltrate. On 24NOV2003, abnormal laboratory data included: other laboratory data is listed below On 26NOV2003, the pt presented with arm pain from flu shot. Treatment included meperidine hydrochloride and an ice wrap. On 01DEC2003, the pt canceled her appointment because she was too weak to come in; been at ER and hospital for five days. On 03DEC2003, she presented to the physician's office with pain under her rib cage, swelling, arm pain and swollen lymph nodes in her neck. She had no appetite, moderate chest pain and was very short of breath. The plan was to check a SED rate. On 12DEC2003, she complained of an increase in swelling and noted that she is broke; no one is helping her; no one knows what's wrong. On 06JAN2004, she was prescribed valdecoxib 10mg po daily. On 15JAN2004, she noted that she can't drive with that arm, hurting for 3 months. She also indicated that she could not lif her purse with that arm. On 21JAN2004, it was noted that the physician wanted to start physical therapy on her arm. The reporter considered the swelling at the site of injection, the excruciating pain in the arm, the inability to raise her arm, the swelling of the lymph nodes and the swelling over the entire body to be immediately life-threatening. Information was received on 23DEC2003 which pertained to an event whcih occurred approximately seven days after vaccination with pneumococcal 23v polysaccharide vaccine. This information contained the following adverse experience: smallleft sided pleural effusion (approximately 24NOV2003) . Additional information has been requested. Follow up information received on 01-Dec-2003 from the patient indicated that she went back into the hospital on 25-Nov-2003. She reported that she was admitted for excruciating pain at the site of injection, and that the swelling is still 3 inches in diameter at the vaccination site. Additional follow up information received from a registered nurse on 11-Feb-2004 indicated taht on 05-Feb-2004, the patient reported to her that her arm was still sore that she was having tingling in her fingers. The nurse also reported that the patient has not been seen in the office for awhile and reports that she cannot come into the office because she can not afford to be seen. Medical records will follow. The reporter considered the swelling at the site of injection, the excruciating pain in the arm, the inability to raise her arm, the swelling of the lymph nodes, and the swelling over the entire body to be immediately life-threatening. Information was received on 23-Dec-2003 which pertained to an event which occurred approximately seven days after vaccination with pneumococcal 23 v polysaccharide vaccine. This information contained the following adverse experienced; small left sided pleural effusion (approximately 24-Nov-2003). Additional information has been requested.				Y	Y				N	11/17/2003	11/17/2003	0	Abdominal ultrasound; Absolute basophil count 0/uL; Absolute eosinophil 76/uL; Absolute lymphocyte 3192/uL; Absolute monocyte count 988/uL; Absolute segemented 3344/uL; Basophil count 0%; Eosinophil count 1%; Hemoglobin 13.5 G/dL; Lymphocyte count 42%; Monocyte count 13%; Platelet count 295 K/uL; Segmented neutrophil 44%; Body height 65 inches; Body weight 154 lbs; Erythrocyte elevated; Mean Corpuscular 29.4pG, 32.4 G/dL, 91 fL; RBC 4.60 M/uL; RDW 13.3%; Serum alanine 24 IU/L; Serum albumin 3.7 G/dL; Serum alkaline 97 IU/L; Serum amylase test 48 U/L; Serum aspartate 24 IU/L; Serum blood urea 8 mG/dL; Serum calcium  8.5 mG/dL; Serum chloride 102 mMOL; Serum creatinine 0.7 mG/dL; Serum glucose 97 mG/dL; Serum potassium 3.2mMOL; Serum sodium 140 mMOL; Total serum bilirubin 0.4 mG/dL; Total serum protein 6.5 G/dL; WBC count 7.6 K/uL; Whole blood bicarbonate 26mMOL; Hematocrit 41.7%. x-ra injection site pending.	OTH	OTH		Peptic ulcer disease	Drug hypersensitivity; Depression; Irritable bowel syndrome; Bronchitis; Gastroesophageal reflux disease; Superinfection		WAES0312USA00048	1						3	Abdominal pain; Anorexia; Chest pain; Cough; Dyspnoea; Fatigue; Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth; Joint range of motion decreased; Laboratory test abnormal; Lymphadenopathy; Myalgia; Nasal congestion; Pain; Pleural effusion; Rash; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|PPV~MERCK & CO. INC.~1196M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~3	USA	Hospitalisation	Influenza
0214720	01/08/2004	WY	35.0	35		F	12/30/2003	Within 24 hours after flu shot, had fever of 103 degrees F, dry heaves, dizziness and fatigue lasted 24 hours.  Weight loss since vaccine from reported weight of 140 to 118.  Started 12 size jeans now at size 7. No appetite and constantly tired.									U	12/03/2003	12/03/2003	0		PUB	PUB	NONE	Fibrotic tumor, non-cancerous removed 01/09/2002	NONE		010104	1						1	Anorexia; Dizziness; Fatigue; Pyrexia; Retching; Weight decreased	FLU3~SANOFI PASTEUR~U1170AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214721	01/08/2004	IL	3.0	3		M	01/07/2004	Influenza vaccine given in left arm at approximately 13:30 on 12/11/03, and hives noted on him from his waist to his feet about 3 hours later.				Y					Y	12/11/2003	12/11/2003	0		PUB	PUB	NONE	NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1260AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214723	01/08/2004	FL	49.0			F	01/02/2004	Mild flu, vomiting, temperature 101, chills, joint pain, tired.  MD said to stay on reg. meds, use ventilator if needed if worse go to ER via ambulance.									Y					PVT	PUB	NONE	NONE	Cerebral Palsy; Asthma Bronchitis; Osteoarthritis; other neuro damage.			1						1	Arthralgia; Chills; Fatigue; Influenza like illness; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0214730	01/08/2004	MD	59.0	58		M	01/06/2004	A legal complaint was received from an attorney alleging that a 59 year old male received an injection of Flu shield on an unspecified date in December 2001. It is alleged that the plaintiff developed Guillain Barre syndrome. According to the medical records, the pt presented to an emergency room on 12/26/01, with a two day history of bilateral facial weakness, difficulty closing his eyes, slurred speech secondary to mouth and labial weakness, difficulty drinking and eating food and liquids falls out of mouth, and decreased ability to stand from a sitting positing. The pt denied double vision, headaches, loss of consciousness, seizures, or any other symptoms. He had recently been diagnosed with sinusitis and had started a course of Levaquin seven days prior to admission. Upon admission to the ER, the pt's physical examination revealed a body temp of 96.4 deg F; blood pressure 150/94; pulse 100 and respirations 28. The pt had sacrral and bilateral 1-2+ pedal edema of the lower extremities, as well as, lower extremity weakness. He was alert and oriented to person, place and time. A CT scan of the head was performed; the results were normal except for mild ethmoid inflammation. There was no evidence of intracranial hemorrhages or masses. A complete blood count was performed: the results are as follows: WBC 8.5; Hgb 15.0; Hct 39.9; platelets 282. An erythrocyte sed rate was 56. Blood chemistries were performed: the results are as follows: glucose 117; BUN .5; creatinine .9; sodium 127; potassium 4.3; chloride 98; and carbon dioxide 24. A lumbar puncture was performed: the results are as follows: the cerebrospinal fluid was clear; total protein 275 and there were no WBC's. The physician indicated that the pt's cranial nerve palsies could be indicative of Lyme meningitis versus Guillain Barre syndrome. Due to the increased total protein in the CSF without WBC, the physician's clinical impression was acute Guillain Barre Miller Fisher Varient. The pt's negative inspiratory force was 60. The physician recommended that the pt be admitted to ICU and treatment should include IVIG versus plasmaphoresis. On that same day, the pt was transferred via helicopter to another facility for admission and evaluation. Upon admission to that facility, the pt's physical examination revealed a body temp was 36.9 deg C; blood pressure 142/81; and respirations 20. The pt was alert, awake, and pleasant though dysarthic speech was noted as well as bilateral facial droop. The lungs were clear. Heart was regular rate and rhythm. Abdomen was soft, nontender, nondistended, with good bowel sounds. There was trace edema in both extremities. On neurological examination, the strength in the upper extremities was 5/5 bilaterally, lower extremities was 4+/5. Deep tendon reflexes in the upper extremities were 1+ symetrically and were absent in the lower extremities. The bilateral Babinski reflexes were downgoing. The pt's sensation was intact but decreased to pinprick, percussion and vibratory sense. Finger-to-toe was intact bilaterally and gait was somewhat wide-based. An unspecified MRI was performed; the results were as follows: degenerative disc disease at L2, 3-4, 4-5, and 5-6. An MRI of the head was performed; the results are as follows: there were a few, nonenhancing, subcentimeter foci of FLAIR and T2 prolongation involving bilateral periventricular white matter. There was no mass or mass effects. The brain morphology appeared unremarkable. There was no pathological enhancement or evidence of acute or hyperacute ischemia. Incidental note was made of mutifocal various amounts of T2 hyperintesity involving bilateral ethmoid air cells. There was no evidence for hemorrhage or hemorrhage products. An MRA revealed no evidence of stenosis, aneurysm, or focal ectasia. There was probable air fluid in the right sphenoid sinus and probable multifocal ethmoid sinus disease. On 1/7/02, the results of the Lyme test on the CSF fluid showed the following: Gram stain showed rare white blood cells and the body fluid culture revealed no definite organisms and rare white blood cells. A diagnosis of Guillain Barre syndrome was made. The pt was plasmapheresed five times over the course of the hospitalization. He was examined by an opthalmoligist for diplopia, the cause of which was concluded to be Guillain Barre syndrome. The pt was examined by a nephrologist for his history of nephrotic syndrome. A renal biopsy was performed; the results revealed membraneous glomerulonephritis. The pt's hospital course was unremarkable and he steadily recovered some of his motor function. His facial droop was markedly reduced but still noticeable bilaterally and his speech was much less dysrthric. On 1/10/02, the pt was considered stabilized and discharged from the hospital. Discharge medications included pre-admission medications plus Lipitor, Lacri-Lube, Zestril, Senakot, Peri-Colace and Vicodin. The pt was scheduled as an outpatient for speech therapy, nephrology and an EMG. The legal complaint alleges that as a result of the lips; permanent impaired vision; permanent inability to control his mouth causing biting of lips and cheeks; permanent inability to control muscles while eating and drinking; and permanent depression and anxiety.				Y	Y	26		Y	U	12/01/2001	12/24/2001	23	Upon admission to the ER, the pt's physical examination revealed a body temp of 96.4 deg F; blood pressure 150/94; pulse 100 and respirations 28. The pt had sacrral and bilateral 1-2+ pedal edema of the lower extremities, as well as, lower extremity weakness. He was alert and oriented to person, place and time. A CT scan of the head was performed; the results were normal except for mild ethmoid inflammation. There was no evidence of intracranial hemorrhages or masses. A complete blood count was performed: the results are as follows: WBC 8.5; Hgb 15.0; Hct 39.9; platelets 282. An erythrocyte sed rate was 56. Blood chemistries were performed: the results are as follows: glucose 117; BUN .5; creatinine .9; sodium 127; potassium 4.3; chloride 98; and carbon dioxide 24. A lumbar puncture was performed: the results are as follows: the cerebrospinal fluid was clear; total protein 275 and there were no WBC's. The physician indicated that the pt's cranial nerve palsies could be indicative of Lyme meningitis versus Guillain Barre syndrome. Due to the increased total protein in the CSF without WBC, the physician's clinical impression was acute Guillain Barre Miller Fisher Varient. The pt's negative inspiratory force was 60. Upon admission to that facility, the pt's physical examination revealed a body temp was 36.9 deg C; blood pressure 142/81; and respirations 20. The pt was alert, awake, and pleasant though dysarthic speech was noted as well as bilateral facial droop. The lungs were clear. Heart was regular rate and rhythm. Abdomen was soft, nontender, nondistended, with good bowel sounds. There was trace edema in both extremities. On neurological examination, the strength in the upper extremities was 5/5 bilaterally, lower extremities was 4+/5. Deep tendon reflexes in the upper extremities were 1+ symetrically and were absent in the lower extremities. The bilateral Babinski reflexes were downgoing. The pt's sensation was intact but decreased to pinprick, percussion and vibratory sense. Finger-to-toe was intact bilaterally and gait was somewhat wide-based. An unspecified MRI was performed; the results were as follows: degenerative disc disease at L2, 3-4, 4-5, and 5-6. An MRI of the head was performed; the results are as follows: there were a few, nonenhancing, subcentimeter foci of FLAIR and T2 prolongation involving bilateral periventricular white matter. There was no mass or mass effects. The brain morphology appeared unremarkable. There was no pathological enhancement or evidence of acute or hyperacute ischemia. Incidental note was made of mutifocal various amounts of T2 hyperintesity involving bilateral ethmoid air cells. There was no evidence for hemorrhage or hemorrhage products. An MRA revealed no evidence of stenosis, aneurysm, or focal ectasia. On 1/7/02, the results of the Lyme test on the CSF fluid showed the following: Gram stain showed rare white blood cells and the body fluid culture revealed no definite organisms and rare white blood cells. syndrome. A renal biopsy was performed; the results revealed membraneous glomerulonephritis.	PVT	OTH	Amatadine; Comtan; Lasix; Levaquin; Lodine; Mirapex; Sinemet	Sinusitis	Back pain, Parkinson's disease diagnosed in 1994, sciatica, peripheral edema, nephrotic syndrome, hyponatraemia, and a hypersensitivity to NSAIDS. Past surgical history is significant for a spinal laminectomy performed in 1999 for low back pain. The pt's mother died of cancer at the age of 68 years. The pt denies tobacco, alcohol, or drug use.		HQWYE960230DEC03	1						1	Anxiety; Depression; Diplopia; Dysarthria; Eye disorder; Facial palsy; Gait disturbance; Glomerulonephritis; Guillain-Barre syndrome; Laboratory test abnormal; Muscular weakness; Nephrotic syndrome; Oedema peripheral	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation,Disabling	Influenza
0214761	01/08/2004	UT	4.0	4		F	01/08/2004	Small red spot turned darker and is continually getting bigger and hot.				Y					Y	01/06/2004	01/07/2004	1		MIL	MIL						1						1	Erythema; Feeling hot; Injection site erythema; Injection site induration; Injection site warmth	DTAP~GLAXOSMITHKLINE BIOLOGICALS~DTPA627A2~5~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1133AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X0148~4~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0611N~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~21899B9~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~2|FLU3~SANOFI PASTEUR~U1133AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~MERCK & CO. INC.~0237N~3~IM~LL~HIB (PEDVAXHIB)~2|PNC~PFIZER\WYETH~492853~3~IM~RL~PNEUMO (PREVNAR)~2	USA	Emergency room visit	Influenza
0214761	01/08/2004	UT	0.5	0	.5	F	01/08/2004	Red area around injection site. Hot and feels hard				Y					Y	01/06/2004	01/07/2004	1		MIL	MIL			born premature			1						2	Erythema; Feeling hot; Injection site erythema; Injection site induration; Injection site warmth	DTAP~GLAXOSMITHKLINE BIOLOGICALS~DTPA627A2~5~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1133AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X0148~4~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0611N~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~21899B9~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~2|FLU3~SANOFI PASTEUR~U1133AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~MERCK & CO. INC.~0237N~3~IM~LL~HIB (PEDVAXHIB)~2|PNC~PFIZER\WYETH~492853~3~IM~RL~PNEUMO (PREVNAR)~2	USA	Emergency room visit	Influenza
0214762	01/08/2004	AK	54.0	53		M	01/08/2004	Within 12 hours of receiving flu vaccine, pt began having subcutaneous swelling in neck bilaterally, but with more edema on side where vaccine was given.  Edema did not cause discomfort. No redness or swelling noted over the site of injection. No pain or pruritis. Edema lessoned over next 24 hours, but continues 4 weeks later. No systemic complaints.									N	12/09/2003	12/09/2003	0	No tests ordered at this time.	UNK	UNK	none	none	None		AK200452	1						1	Injection site swelling; Swelling	FLU3~SANOFI PASTEUR~U1141AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214763	01/08/2004	AK	47.0	47		F	01/08/2004	WITHIN 12 HOURS OF RECEIVING FLU VACCINE, PATIENT BEGAN HAVING SUBCUTANEOUS SWELLING IN NECK BILATERALLY, BUT WITH MORE EDEMA ON SIDE WHERE VACCINE WAS GIVEN.  EDEMA DID NOT CAUSE DISCOMFORT.  NO REDNESS OR SWELLING NOTED OVER THE SITE OF INJECTION.  NO PAIN OR PRURITIS.  EDEMA LESSONED OVER NEXT 24 HOURS, BUT CONTINUES 4 WEEKS LATER.  NO SYSTEMIC COMPLAINTS.									U	12/09/2003	12/09/2003	0	NO TEST ORDERED AT THIS TIME.	UNK	UNK	NONE	NONE	NONE		AK200453	1						1	Oedema	FLU3~SANOFI PASTEUR~U1141AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213214	01/09/2004	IA	65.0	65		M		A report was received from a health care professional on 12/1/03 concerning a 65 year old male vaccinee who experienced cardiac/respiratory arrest, shock secondary to anaphylaxis and died on 11/30/03 in hospital at 10:55 PM after receiving Fluvirin vaccine on the same day at 8:45 PM. Co-medication included metaprolol succinate. On 11/30/03 at 8:45 PM, the vaccinee (who was a physician) was administered Fluvirin. At 9:30 PM the vaccinee called the emergency department of the hospital to indicated that he was experiencing a reaction. At 10:55 PM the vaccinee developed cardiac/respiratory arrest, experienced shock secondary to anaphylaxis and died in hospital. The vaccinees wife stated that he had received the influenza vaccine for the past 28 years without incident. There was insufficient information to determine the reporter's causality assessment. Follow up pending.	Y	11/30/2003			Y				N	11/30/2003	11/30/2003	0		UNK	UNK	Toprol XL				PJP200301214	1						2	Anaphylactic reaction; Cardiac arrest; Respiratory arrest; Shock	FLU3~EVANS VACCINES~765705~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Results in Death	Influenza
0214743	01/09/2004	NY	12.0	12		M	12/10/2003	0.5cc vaccine administered IM, immediately child's color became pale, child started to moan, began to fall, child was eased to floor, feet elevated, ammonia spirits revived child immediately. Child was transferred to 3 chairs to lay down off of floor, B/P was 80/48 then after 5 minutes was 82/60, child rested. Juice administered. Child left with father to go to MD.									Y	12/10/2003	12/10/2003	0	NONE	PUB	UNK		NONE				1						1	Fall; Pallor	FLU3~SANOFI PASTEUR~U1131AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214744	01/09/2004	MI	72.0	72		F	10/17/2003	Left arm swelling and warmth increasing over 2 days from time of vaccine. On 10/17 4 in diameter surrounding erythema with minimal warmth and slight tenderness.				Y					Y	10/15/2003	10/15/2003	0	NONE	OTH	OTH	Actonel, Nexium, Avestra, Prinivil	NONE	NKDA, HTN, osteoporosis			1						1	Erythema; Feeling hot; Oedema peripheral; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0214745	01/09/2004	CA	34.0			F	12/29/2003	Within 20 minutes of vaccination I was wheezing and not breathing well. Over the course of several hours it got worse. I went into the doctor and my blood pressure was severely elevated and I wasn't breathing well. I had to go back 2 more times over the next 2 days for cortisone shot, breathing treatments, etc. I'm still breathing rough sometimes.				Y					U				Doctors have this info.	OTH	PVT	NONE	NONE	NONE			1						1	Dyspnoea; Hypertension; Wheezing	FLU3~SANOFI PASTEUR~U1142AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214746	01/09/2004	MD	75.0	76		M	01/05/2004	Rash and itch on arm (left particularly) and chest and stomach.									Y	11/13/2003	11/13/2003	0		OTH	PUB				rash, itch~Influenza (Seasonal) (no brand name)~~74.00~In Patient		1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214771	01/12/2004	TX	42.0	41		F	12/19/2003	Patient is a 41 year old female with 2 prior episodes of neutropenia on clozapine with clozapine being subsequently discontinued on 8/12/03. At the time of discharge the patient was also on Valproic acid 1500mg BID and Abilify 30mg QD. On 9/5/03, Risperdal 2mg was initiated and increased to 6mg. No other medication changes were made until 10/28/03 when the influenza vaccine was administered. On 11/4/03 the ANC = 0.7, 11/5/03 ANC = 0.8 and aripprazole was discontinued and VPA decreased to 1000mg BID. On 11/6/03, ANC = 0.6 abd Resperdal was discontinued and Valproic acid was decreased to 500mg BID. 11/8/03 ANC = 1.2. VPA decreased. 11/10/03 ANC = 1.8 and patient on no meds at this time. Pt developed agranulo cytocis approximately 1 week after being given the flu vaccine. ANC went back up to 1.8 on 11/10/03.			Y	Y					Y	10/28/2003	11/04/2003	7	11/4/03 ANC 0.7; 11.5/03 ANC 0.8; 11/6/03 ANC 0.6; 11/7/03 1.1; 11/8/03 1.2; 11/10/03 1.8; 1/12/03 ANC 2.9 (10/28 given vaccine)	PUB	PUB	Valproic Acid; Aripiprazole; Risperidone	Schizophrenia Discharge summary states tobacco addiction. msv	2 previous episodes of neutropenia with clozapine; Clozapine discontinued 2 months prior to episode of agranulocytosis; No pre-existing medical conditions noted.			1						1	Agranulocytosis; Neutropenia	FLU3~SANOFI PASTEUR~U1128AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0214772	01/12/2004	OK	66.0	66		F	10/20/2003	The flu vaccine was administered at 14:45 on 10/15/03. At 16:00, the pt's arm was noted to be painful and swollen at the injection site. A warm pack was applied and the pt was observed for an hour prior to discharge.									Y	10/15/2003	10/15/2003	0		PVT	PVT		Admitted for chest pain	Penicillin/sulfa allergies			1						1	Injection site oedema; Pain	FLU3~SANOFI PASTEUR~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214773	01/12/2004	CA	36.0	36		F	12/30/2003	Pt had dizziness and some hives on her right lower arm 10 minutes after she had the flu vaccine.									Y	12/03/2003	12/03/2003	0		PVT	PVT		NONE				1						1	Dizziness; Urticaria	FLU3~EVANS VACCINES~765879~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214774	01/12/2004	PA	45.0	45		M		Fever, diarrhea, nausea and vomiting, body aches, fatigue within minutes of getting flu shot. No problem with flu shot previously.				Y					Y	12/08/2003	12/08/2003	0	NONE	PVT	PVT		NONE				1						1	Diarrhoea; Fatigue; Nausea; Pain; Pyrexia; Vomiting	FLU3~EVANS VACCINES~766054~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214775	01/12/2004	CT				F	01/05/2004	Systemic vasculitis 1 week after vaccination.									U	12/06/2003	12/13/2003	7		UNK	UNK						1						1	Vasculitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0214776	01/12/2004	NC	79.0	79		M		Difficulty breathing, wheezing, weak, paleness, rapid heartbeat, fluid in lungs, could not sleep.				Y					N	12/05/2003	12/05/2003	0		PVT	PVT						1						1	Asthenia; Dyspnoea; Heart rate increased; Insomnia; Lung disorder; Pallor; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0214777	01/12/2004	NY	39.0	39		M	10/30/2003	Pt developed hives evening of flu vaccine, went to ED, treated with Benadryl and Prednisone.				Y					N	10/16/2003	10/16/2003	0	NONE	PVT	UNK		NONE	NONE			1						1	Urticaria	FLU3~EVANS VACCINES~765502~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214778	01/12/2004	OH	65.0	65		F	01/02/2004	After vaccine, developed a lump in arm at injection site. It became painful immediately and the pain increased on 12/20/03 to her arm and breast. Now 2 weeks later, she finds it difficult to raise her arm and pain continues. 12/30/03 attended Urgent Care, given sling with Vicodan with no relief. To see Dr today. Had similar problem with Hong Kong flu shot, but not with flu shots since. Dr prescribed Vioxx 1/2/04.									N	12/12/2003	12/20/2003	8		PUB	PUB	Zoloft, Dyazide, Premarin, Norvasc, Colazil, Lipitor, Vioxx	NONE	Colitis	pain in arm~Influenza (Seasonal) (no brand name)~1~0.00~In Patient		1						1	Injection site mass; Injection site pain; Joint range of motion decreased	FLU3~SANOFI PASTEUR~U1131AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214779	01/12/2004	TX	73.0	73		F	01/06/2004	A friend and I who planned a trip chose to have flu shots after many previous ones. We did on 10/10/03. There were no unexpected symptoms till about 9:15 following 1st service about 9:15 10/12/03. I'd been up since 5:00, read paper, sang at 1st service and then began feeling feel. Underlined symptoms on sheet given us were all experienced ending in a 911 call and rest at hospital till I came out of it all about 5:30 PM and was sent home Tues to get ready for (unreadable).				Y	Y	2			Y	10/10/2003	10/12/2003	2	hospital records	OTH	PUB	Atenol, Levathroid, Terragosin, Glucagamine/Chandritine	NONE	Allergic to sulfa, chloromycetin, Cipro			1						1	Asthenia	FLU3~SANOFI PASTEUR~U1095AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0214780	01/12/2004	UT	0.67	0	.7	M	01/02/2004	12/31/03: 5:05 PM mom called pt, fever 102 degrees, Tylenol was given. 1/2/04: called mom to check on pt. Still has fever, not eating well. I told her to take him to ER for check up. 1/5/04: call today, pt is OK, mom didn't take him to ER, states he is fine.									Y	12/31/2003	12/31/2003	0		PUB	PUB	NONE	NONE	NONE			1						1	Decreased appetite; Pyrexia	DTAP~GLAXOSMITHKLINE BIOLOGICALS~602A2~3~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1142AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~1172M~3~IM~LL~HIB + HEP B (COMVAX)~1|IPV~SANOFI PASTEUR~W1440~3~SC~RL~POLIO VIRUS, INACT. (POLIOVAX)~1|PNC~PFIZER\WYETH~492858~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0194213	01/13/2004	NM	59.0	58		F	01/08/2004	Information has been received from a physician concerning a 59 year old female with an allergy to codeine who on 11/13/02 at 1:30pm was vaccinated in the left arm deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (643251/0445M). Concomitant therapy that day included a dose of influenza virus vaccine in the same site. The pt has reported redness and pain at the injection site. No other information was available. Unspecified medical attention was sought. There was no product quality complaint. Follow up info indicated that on 11/18/02 the site of injection was a 2x2 and 1/2 necrotic area. This area was surgically removed 2 weeks later. Upon internal review, the necrotic area was considered to be an other important medical event (OMIC). Additional info has been requested.				Y					U	11/13/2002	11/18/2002	5	UNK	PVT	OTH			Codeine (comatose)		WAES0312USA00335	1						3	Injection site erythema; Injection site necrosis; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|PPV~MERCK & CO. INC.~0445M~UNK~~LA~PNEUMO (PNEUMOVAX)~3	USA	Emergency room visit	Influenza
0214238	01/13/2004	WA	68.0	68		F	12/16/2003	12/8/03 8:00 AM received flu vax. By 8:45 while returning home with husband she felt nauseated, weak, right side neck swelling, rash, no SOB, no difficulty swallowing, no itching. Next day rash spread to chest, body felt hot, by 12/11/03 pt continued with nausea and dizziness. No vomiting, no diarrhea, weak. Called 911. To ER, see attached ER notes and lab. Rash on legs elevated blots red dots, eyes puffy. 12/17/03 rash on legs. Referred to PMD for further evaluation.				Y					U	12/08/2003	12/08/2003	0	CBC, UA, EKG, CMP	PUB	PVT	Veralan, Cortaid cream, Lipitor, HCTZ, ASA, KCL, vitamins, Allegra, Tylenol	NONE	Codeine, sulfa, Eryth, PCN, Iodine dye, Benadryl, Buspar			1						2	Asthenia; Dizziness; Eye swelling; Feeling hot; Nausea; Oedema; Rash	FLU3~SANOFI PASTEUR~U1143AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0214810	01/13/2004	PA	38.0	36		F	12/31/2003	Developed fever, flu-like symptoms and ongoing infection which resulted in pneumonia. Also developed lupus which resulted in pneumonia caused by pseudomonas and staphaureous infection-IV for 4 weeks after one week hospitalization. The medical record received on 2/11/04 states short of breath, vomiting, chest pain, constipation and productive cough.				Y	Y	6			U	11/21/2001	11/25/2001	4	2 years worth of tests and treatment on file. Lab test abnormal.	PUB	PVT		NONE	Seasonal allergy	Titer was (-) after the last series.~Hep B (no brand name)~3~37.00~In Patient		1						1	Bacterial infection; Chest pain; Constipation; Cough; Dyspnoea; Influenza like illness; Laboratory test abnormal; Pneumonia; Pyrexia; Systemic lupus erythematosus; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~MERCK & CO. INC.~~6~~LA~HEP B (RECOMBIVAX HB)~1	USA	Hospitalisation	Influenza
0214813	01/13/2004	WA	48.0	49		F		Muscle aches in upper arm and neck for months. Sharp stabbing pains yet in upper arm, and weakness.								Y	U	11/07/2002	11/09/2002	2		PVT	OTH	Norpramin	NONE				1						1	Asthenia; Myalgia; Pain	FLU3~SANOFI PASTEUR~U0920AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0214814	01/13/2004	AK	1.5	1	.5	M	12/12/2003	Swelling and redness of entire right thigh in which the vaccine was given.				Y					U	12/11/2003	12/11/2003	0		PUB	UNK		NONE	NONE		AK200401	1						1	Injection site erythema; Injection site oedema	DTAP~GLAXOSMITHKLINE BIOLOGICALS~610A2~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1141AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214815	01/13/2004	NJ	1.67	1	.7	M	01/09/2004	Eye looked puffy after administration one hour later. Treatment Benadryl.									Y	12/31/2003	12/31/2003	0		UNK	UNK						1						1	Eye inflammation	FLU3~SANOFI PASTEUR~U1075AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214817	01/13/2004	CA	52.0	52		F	01/08/2004	Right arm pain since 11/18/03. Unresolved as of 12/30/03, but states her arm is getting better. She is going to physical therapy due to this event, and being followed by her doctor(s) for treatment.									N	11/18/2003	11/18/2003	0		OTH	UNK			Allergic-Zithromax; Hepatitis C, Positive Rheumatoid Factor, GERD			1						1	Pain	FLU3~SANOFI PASTEUR~U1149GA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214818	01/13/2004	MA	42.0	42		F	01/06/2004	Localized soreness (aching) pain on right deltoid. Occasionally refers distally down arm, half-way to elbow. No weakness. Using arm makes worse. Worse in morning or with pressure. Aleve helps. Symptoms improving during day, not upon awakening. Visit with PCP scheduled for 1/8/04. Somewhat				Y					N	12/08/2003	12/11/2003	3		PUB	PVT	Allegra, Levoxyl, Femort, multivitamins	NONE	Turner's syndrome, hypothyroidism			1						1	Joint range of motion decreased; Pain	FLU3~EVANS VACCINES~766055~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214822	01/13/2004	TN	3.0	3		F	01/06/2004	Urticarial rash developed around vaccine injection site about 4 hours after injection. Spread subsequently to involve face, trunk and proximal extremities. Pt seen in office 24 hours after injection, rash only faintly visible.				Y					Y	01/05/2004	01/05/2004	0	NONE	PVT	PUB	NONE	Viral upper respiratory infection	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1254AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214823	01/13/2004	MO	25.0	25		F	01/03/2004	I started to have a fever, cold chills, body ache, hot and cold flashes and sweats, it was like I was going through the flu. Went to the ER, they said let it run its course. At the end of 72 hours, it was over.				Y					Y	12/19/2003				PUB	OTH	NONE	Lightheaded, cold chills	PCOS			1						1	Chills; Hot flush; Hyperhidrosis; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0214842	01/13/2004	VA	1.25	1	.3	M		A report was received from a health care professional on 11/12/03, concerning a 15 month old male vaccinee who inadvertently received Fluvirin on 11/12/03. On 11/12/03, the vaccinee inadvertently received Fluvirin 0.5ml IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficiently information to determine the reporter's causality assessment. Update 1/2/04: A follow up report was received on 1/2/04 which indicated that the vaccinee had experienced 2 seizures due to increased temperature on an unspecified date. The vaccinee was hospitalized on 11/14/03 and was discharged on 11/15/03. The vaccinee had also received a DTP vaccine and a combined Haemophilus influenzae B and hepatitis B vaccine. It was not reported if the vaccinee had recovered at the time of the report. Follow up pending. Update 2/3/04: Further information was received from a health care professional on 2/3/04 indicating that the vaccinee experienced one febrile seizure on 11/13/03 due to an elevated temperature. The vaccine's mother stated that she had experienced febrile seizure as a child. The vaccinee received the DTaP vaccine and combined Haemophilus influenzae B and hepatitis B vaccine on 11/12/03. The vaccinee was seen in the emergency room on 11/13/03 and subsequently hospitalized on 11/14/03 to 11/13/03 for observation. The vaccinee recovered on an unspecified date. Follow up pending.					Y				U	11/12/2003				UNK	UNK					PJP200301059	1						1	Convulsion; Pyrexia	FLU3~EVANS VACCINES~765753~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0214852	01/13/2004	MI	39.0	39		F	01/13/2004	Patient was diagnosed with a non Q-wave myocardial infarction on 21 May 03 (4 months after receipt of Anthrax #1, Hep B #1, Hep A #2, Influenza, Meningococcal, Smallpox, and Yellow Fever Vaccinations and 2.5 months after receipt of Anthrax #2 and Hep B #2).  She reports that she started experiencing chest pain one week after receiving the January 2003 set of vaccinations.  She experienced similar chest pain the second week in February, and at the end of March.  She did not seek medical evaluation until the chest pain episodes returned on 5/20/03 while she was deployed.  After an elevated CPK (peak of 317) and elevated troponin (result not listed in available medical records), the patient was medically evacuated to a Medical Center.    While at the medica center, cardiac enzymes were abnormal with a peak CK of 98 (Nml), CK-MB of 12 H, and initial troponin of 21 H.  A cardiac catheterization revealed a right dominant coronary system with branch vessel disease.  She had a very small first obtuse marginal branch that had a 90% ostial lesion in it.  She also had a 60% ostial moderate size diagonal branch lesion.  Given her cardiac cath findings, as well as continued chest discomfort, she remained in the ICU.  During this time, she continued to have chest pain, and she was placed on a full Bruce treadmill test.  She did not develop any ischemic ECG changes on the treadmill.  Given these findings but with continued chest pain, her physicians did not feel that her chest pain was cardiac related.    A PA/Lateral chest x-ray revealed a blunt right hemidiaphragm consistent with a small effusion.  A repeat chest x-ray five days later showed that the effusion had resolved.  An abdominal ultrasound was performed, which was unremarkable other than a nondistended gallbladder.  A gastroenterology consult was obtained, and a esophagogastroduodenoscopy was performed which revealed a small erosion on the antral portion of the stomach.  However, this was not felt to be causal of the chest pain.  She was placed empirically on Aciphex.  While at the medical center, a psychiatry consult was obtain to evaluate her eating habits, and she was diagnosed with anorexia nervosa of a restricted type.  No medications were started for this.  She stayed at the medical center for 2-3 weeks before being transferred to another medical center for further evaluation. Her discharge medications include Lopressor 25 mg po BID, Plavix 75 mg po QD, and Aciphex 20 mg po BID.  Her evaluation showed:  On 06 Jun 03, during cardiology eval, her EKG showed NSR, NL EKG.  GXT-Thall obtained on 6/9/02 showed moderate to severe diminished activity in the anterolateral wall after 12:56 minutes, which improves with rest.  EF=55%.  TTE (6/10/03):  Normal echo with EF=60-65%.  Dr indicated that although her MPS showed ischemia in the anterolateral wall, her ability to exercise for 12:55 minutes without cardiac symptoms translates in a good prognosis.  He also reported that she was having non-cardiac chest pain:  most likely musculoskeletal in nature and referred her to internal medicine.  Her medications included metoprolol, Plavix, Aciphex, and Zocor. She received evaluation by Internal Medicine for work-up of Non-cardiac chest pain.  Thought to be likely costochondritis-referred for PA Chest x-ray (Records indicate nml Chest x-ray.) 60 day follow 4/5/2004: She continues to experience daily chest pain with exertion and at rest. She is under the care of physicians including cardiology, gastroenterology, and internal medicine. Per annual report- As of 13 Jan 04, patient still experiences chest pain routinely.  Follow-up care with primary physician and cardiologist was pending.			Y	Y	Y	3			N	01/29/2003	05/20/2003	111	oDiagnostic Tests:    Upper GI Series  01 Oct 2003   IMPRESSION:  1.  Mild to moderate gastroesophageal reflux and a mild to moderate hiatal hernia is present.  Would recommend therapy for this.  If symptoms persist, a follow-up upper GI series would be helpful.  2.  Findings suggestive of at least gastritis.  Treadmill Exercise with Rest and Stress/ Cardiolite Myocardial Imaging 08/14/03   IMPRESSION:  Negative Stress Test.  No evidence of ischemia, normal wall motion and EF (EF=67%).  Echocardiogram  08/12/03- Cardiology IMPRESSION:  Normal echo Doppler.  Overall left ventricular function is normal with an estimated EF of 60-65%.  No pericardial effusion is seen and no valvular or structural abnormalities are noted.  There are no intracardiac shunts.  Doppler flows are normal.  Chest X-ray  11 June 2003 :     FINDINGS: There are normal lung volumes.  Lungs are clear.  Cardiomediastinal silhouette and pulmonary vasculature are normal.  Osseous structures are unremarkable.  IMPRESSION:  NO ACUTE DISEASE.    MYOCARD PERFUSION (SPECT) MULTI-ST  Exam Date: 09 Jun 2003@0708 FINDINGS:  LVEF 55% with normal wall motion.  Under myocardial stress conditions, there is a moderate to severe diminished activity about the anterolateral wall which improves in the resting conditions.  This is in the distribution of the first diagonal vessel.  IMPRESSION: ABNORMAL MYOCARDIAL PERFUSION STUDY AS DESCRIBED ABOVE WITH FINDINGS CONSISTENT WITH ISCHEMIA IN THE ANTEROLATERAL DISTRIBUTION CONSISTENT WITH FIRST DIAGONAL OBSTRUCTIVE VESSEL. LVEF 55%.  Lung Ventilation-Perfusion Scan  Exam Date 04 Jun 2003 . FINDINGS:  Area of relative photopenia corresponding in location to the oblique fissure of the left lung.  Relative widening of this area of photopenia in the mid-lung.  Additionally, there is mild, relatively decreased perfusion to the right lung apex.  The mediastinal and cardiac silhouettes are normal in appearance.  The ventilation images show matching, though less prominent, areas of relative photopenia in the oblique fissure of the left lung and in the right apex.  A moderate amount of gastrointestinal activity is observed in the ventilation images.  IMPRESSION:  MATCHING, NONSEGMENTAL PERFUSION AND VENTILATION DEFECTS WITH A PATTERN SUGGESTIVE OF FLUID IN THE LEFT OBLIQUE FISSURE CONSISTENT WITH A LOW PROBABILITY FOR PULMONARY EMBOLISM.  Cardiac Catheterization  Exam Date 23 May 03 Final Impression:   1. Right dominant coronary artery system with significant  disease involving a very small branch of the circumflex system. 2. Normal overall LV systolic function without segmental wall motion abnormalities or mitral regurgitation. 3. Final plan:  Given the relatively small size of the affected vessel, she was not considered a good candidate for revascularization.   Laboratory Data:    o Results from Medical Center 5 Jul 03 @ 0840 (Coll        PROTEIN TOTAL . . . . .   6.7                (6.3-8.2)       g/dL        ALBUMIN . . . . . . . .   3.5     L          (3.9-5.0)       g/dL        ALK PHOS. . . . . . . .  70                   (38-126)       U/L        AST . . . . . . . . . .  23                   (14-50)        U/L        ALT . . . . . . . . . .  20                    (9-52)        U/L        TBILI . . . . . . . . .   0.6                (0.2-1.3)       mg/dL        DBILI . . . . . . . . .   0.1                (0.0-0.4)       mg/dL        CK. . . . . . . . . . .  66                   (30-135)       U/L      15 Jul 03 @ 0840 (Coll        CHOLESTEROL . . . . .   191                   (50-200)       mg/dL        TRIGLYCERIDE. . . . .   169                   (35-250)       mg/dL +      HDL . . . . . . . . . .  47                   (35-82)        mg/Dl     LDL (DIRECT). . . . .   119                    (0-129)       mg/dL        VLDL. . . . . . . . . .  25                                          CHOL TOT/HDL. . . . . .   4.06                                  11 Jun 03 @ 1328 (Coll        CHOLESTEROL . . . . .   311       H           (50-200)       mg/dL        TRIGLYCERIDE. . . . .   162                   (35-250)       mg/dL        HDL . . . . . . . . . .  66                   (35-82)        mg/dL        LDL (DIRECT). . . . .   211       H            (0-129)       mg/dL        VLDL. . . . . . . . . .  34                                          CHOL TOT/HDL. . . . . .   4.71                                     06 Jun 03 @ 0958 (Coll +      HIV-1 AB. . . . . . .  NEGATIVE                (NEG)          06 Jun 03 @ 0958 (Coll o        G6PD. . . . . . . . . .  NORMAL              (NORMAL)     o Results from 21 May 2003 Glucose  94 BUN  8 Creatinine 0.9 Na  137 K  4.1 Cl  107 CO2  21 CPK  138 2nd CPK 317	MIL	MIL	o Prior to her MI, she was only taking Vitamin E o After her MI, she started: -  Librax (chlordiazepoxide/clidinium)  qd for my hiatal hernia - Rabeprazole 20 mg po BID - Plavix 75 mg po qd - Zocor 40 mg po qd - Atenolol ?mg qd - Darvocet	None	o Hiatal Hernia, Gastritis o Migraines o Osteoarthritis L Knee o Diagnosed with hyperlipidemia during evaluation at medical center o Denies any history of valvular heart disease, HTN, CVA, Carotid artery disease, anemia, asthma, cancer, diabetes, eczema or chronic skin disorders, gallbladder disease, hepatitis, or thyroid disease.			1						1	Chest pain; Gastrooesophageal reflux disease; Laboratory test abnormal; Myocardial infarction; Skin ulcer; Anorexia nervosa; Chest pain; Laboratory test abnormal; Myocardial infarction; Pleural effusion; Anorexia nervosa; Blood creatine phosphokinase increased; Chest discomfort; Chest pain; Myocardial infarction	ANTH~EMERGENT BIOSOLUTIONS~FAV073~1~SC~UN~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~Unknown~5~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~Unknown~1~IM~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~Unknown~2~IM~UN~HEP A (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~Unknown~2~SC~UN~MENINGOCOCCAL (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4020071~1~ID~UN~SMALLPOX (DRYVAX)~1|YF~UNKNOWN MANUFACTURER~Unknown~1~SC~UN~YELLOW FEVER (NO BRAND NAME)~1|ANTH~EMERGENT BIOSOLUTIONS~FAV073~1~SC~UN~ANTHRAX (BIOTHRAX)~2|FLUX~UNKNOWN MANUFACTURER~~5~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEPA~UNKNOWN MANUFACTURER~~2~IM~UN~HEP A (NO BRAND NAME)~2|MEN~SANOFI PASTEUR~~2~SC~~MENINGOCOCCAL (MENOMUNE)~2|SMALL~PFIZER\WYETH~4020071~1~ID~UN~SMALLPOX (DRYVAX)~2|YF~SANOFI PASTEUR~~1~SC~~YELLOW FEVER (YF-VAX)~2|ANTH~EMERGENT BIOSOLUTIONS~FAV093~1~SC~UN~ANTHRAX (BIOTHRAX)~3|FLUX~UNKNOWN MANUFACTURER~~5~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|HEP~UNKNOWN MANUFACTURER~~1~IM~UN~HEP B (NO BRAND NAME)~3|HEPA~UNKNOWN MANUFACTURER~~2~IM~UN~HEP A (NO BRAND NAME)~3|MEN~SANOFI PASTEUR~~2~SC~~MENINGOCOCCAL (MENOMUNE)~3|SMALL~PFIZER\WYETH~4020071~1~ID~UN~SMALLPOX (DRYVAX)~3|YF~SANOFI PASTEUR~~1~SC~~YELLOW FEVER (YF-VAX)~3	USA	Life Threatening,Hospitalisation	Influenza
0214906	01/13/2004	VA	57.0	57		F	01/13/2004	Flu vaccine adm 12/5/03.Pt. states she felt somewhat SOB 12/7/03 but got much worse 12/08/03. Chest tightness, SOB, Increase BP.Went to ER . Blood tests, x-ray ,EEG done.Pt. discharged from ER.Symptoms subsided but started again the next day. Went to ER via ambulance 12/9/03. Bld tests, CAT scan, stress test all WNL. Patient d/c from hospital 12/10/03.				Y	Y	1			Y	12/05/2003	12/08/2003	3		PUB	PUB		Client stated after incident to the interviewer that she reacts to the vaccine every year but this was the worse time.  She however filled out her permission sheet as though she had not had a reaction before when asked.	None noted On the consent form when asked if she had any allergies to eggs,latex,thimersol,medication,any vaccine, or other vaccine componet she answered NO.			1						1	Blood pressure increased; Chest discomfort; Dyspnoea	FLU3~EVANS VACCINES~766045~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0214907	01/13/2004	VA	22.0	22		F	01/13/2004	NONE									U	11/04/2003	11/04/2003	0	PATIENT WITH LMP OF 25 OCT 03, POSITIVE HCT ON 5 DEC 03.	MIL	MIL	INFLUENZA IMMUNIZATION	NONE	? PREGNANCY			1						1	Laboratory test abnormal; Unevaluable event	ANTH~MICHIGAN DEPT PUB HLTH~~UNK~~~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0214908	01/13/2004	AR	21.0	20		F	01/13/2004	2-3 days after flu-mist had fever, malaise.  2 wks later Bilateral facial nerve palsy and peripheral neuropathy - ALL CONSISTENT WITH GUILLIAN-BARRE Medical records states facial paralysis, asthenia. msv			Y		Y	6			N	12/16/2003	01/03/2004	18	csf with elevated protein and otherwise normal cytology.  Normal CT/MRI	UNK	UNK	levoquin, effexor, ultracet - ALL STARTED AFTER SYMPTOMS (WEAKNESS) STARTED	none	none Medical records state allergy. msv			1						1	Asthenia; Facial palsy; Guillain-Barre syndrome; Laboratory test abnormal; Malaise; Neuropathy peripheral; Paralysis; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500034P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Life Threatening,Hospitalisation	Influenza
0214859	01/14/2004	CA	55.0	55		M	01/13/2004	12/30/03-extreme fatigue, 1/1/04 muscle weakness, 1/4-5/04-N/V, 1/3 HA, seeing double, 1/5-6/04 progressive weakness 1st hands then feet, hospitalized 1/6/04. Ptosis of R eye. Miller Fisher variant of Guillain Barre syndrome. The medical records received on 1/20/04 states URI, diplopia, ataxia, numbness, neck weak, absent refleses, and lethargy. 60-day follow up on 04/21/04: Pt has not recovered from adverse event. Still recovering as of 04/08/04. Decreased stamina, persisting double vision, weakness in arms and legs. Per annual report- Per MD check-up, patient has recovered 45% of strength.  Patient has tingling sensation on hands.  No longer has double vision.				Y	Y	8			Y	10/10/2003	12/30/2003	81	Miller Fisher variant of Guillain Barre syndrome. Labs abnormal.	PVT	PVT	Baby ASA, Lipitor	NONE	Elevated cholesterol			1						1	Coordination abnormal; Diplopia; Eyelid ptosis; Fatigue; Headache; Hypoaesthesia; Lethargy; Miller Fisher syndrome; Muscular weakness; Nausea; Paraesthesia; Upper respiratory tract infection; Vomiting	FLU3~SANOFI PASTEUR~U1070AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0214860	01/14/2004	CA	30.0	30		M	01/13/2004	12/16 weakness in legs/feet. Hypersensitivity over all body. Progressive ascending paralysis including hands. Hospitalized 12/25-26, ICU, currently decreased sensation/weak upper extremities. Paralysis from untulitus-feet. The medical record received on 1/16/04 states parathesis, chest congestion, URI, body aches, fever/ chills, urinary retention, prostitis, gait unstable, subacute necrotizing myelitis/ transverse myelitis, constipation and stiff neck. The discharge summary received on 3/23/04 states mild bsilar atelectasis, liver function abnormalities and ascities. The medical record received on 3/23/04 states auto-immune process and viral syndrome. 60-day follow up on 04/21/04: Pt has not recovered from adverse events.  In wheel chair, nerve pain, decreased pain sensation in legs.  Continues to receive physical therapy for condition.  Pt continues under a physician's care for the GBS. Per annual follow up currently is able to walk, has no numbness from about the umbilicus down.			Y	Y	Y	18			Y	11/24/2003	12/10/2003	16	CSF, blood, stool. CSF abnormal, MRI abnormal. Hepatic lab values abnormal.	OTH	OTH	Exlodrim, Thera Flu	NONE	Acid indigestion-Tretums prn, sickle cell trait, vascular malformation			1						1	Ascites; Asthenia; Atelectasis; CSF test abnormal; Chills; Constipation; Gait disturbance; Hypersensitivity; Immune system disorder; Liver function test abnormal; Muscular weakness; Musculoskeletal stiffness; Myelitis transverse; Pain; Paralysis; Prostatic disorder; Pulmonary congestion; Pyrexia; Sensory disturbance; Upper respiratory tract infection; Urinary retention	FLU3~EVANS VACCINES~765145~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0214862	01/14/2004	IL	84.0	83		M	01/08/2004	After one week, was in hosp. for 2 wks with pneumonia. The discharge summary received on 1/28/04 states fever, chills, weakness and hyponatremia.					Y	14			Y	10/18/2002	10/23/2002	5	Lab test abnormal	OTH	PUB	Lipator	NONE	Peripheral neuropathy, hypertension, peripheral vascular disease, psoriasis, siezure disorder, Hyperlipidemia			1						1	Asthenia; Chills; Hyponatraemia; Laboratory test abnormal; Pneumonia; Pyrexia	FLU3~EVANS VACCINES~33142GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0214863	01/14/2004	IL	85.0	84		M	01/08/2004	Loss of strength, bad all over. Went to Dr 4 times. He said what I had was polymyalgia rheumatica. Tripped by the flu shot. I am still weak.				Y					Y	10/30/2003	10/31/2003	1		OTH	PUB		NONE				1						1	Asthenia; Malaise; Polymyalgia rheumatica	FLU3~EVANS VACCINES~765874~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214864	01/14/2004	HI	2.0	2	.5	F	12/11/2003	Pt got shots 12/9/03 and on 12/11/03 pt developed right lower hip with urticarial lesions (erythema multiforme). Shot site had no rash and tenderness or swelling, there was no SOB.									Y	12/09/2003	12/10/2003	1	NONE	PVT	PVT						1						1	Erythema multiforme; Skin ulcer; Urticaria	FLU3~SANOFI PASTEUR~U1184BA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~767A2~1~~RL~HEP A (HAVRIX)~1	USA		Influenza
0214865	01/14/2004	CO	54.0	54		F	01/08/2004	At approximately 24 hours from the time I received the flu shot this season, I developed a rapid and irregular heartrate/beat with overall feeling of wooziness and weakness, which resolved about 3 hours later.									Y	11/01/2003	11/02/2003	1	Took my own pulse and discovered very irregular beats, many rapid.	PUB	OTH	NONE	NONE	I am not supposed to take penicillin-related drugs (one reaction in '99)			1						1	Asthenia; Dizziness; Heart rate increased; Heart rate irregular	FLUX~UNKNOWN MANUFACTURER~~7+~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0214866	01/14/2004	VA	34.0	34		F	12/01/2003	11 AM received vaccine. 12 PM Pt noticed redness on neck and trunk. 2 PM redness less on neck and trunk.									Y	12/01/2003	12/01/2003	0		OTH	PUB	Lorezapan	NONE	Allergy to Sumatrptin, penicillin			1						1	Erythema	FLU3~EVANS VACCINES~765875~6~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214867	01/14/2004	CA	52.0	52		F	01/08/2004	Pt called after returning home and reported the development of hives after getting the flu shot.									Y	11/14/2003	11/14/2003	0	NONE	PVT	PVT		Eczema	Sulfa (hives)			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1253AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214868	01/14/2004	KS	47.0	47		M	11/20/2003	Onset Thurs evening with temperrature (102-103) through Friday. Achiness, sweats, dizziness and decrease in sleep. Monday night developed an itchy petechia rash on legs (bilaterally), lower shin area.				Y					Y	10/22/2003	10/23/2003	1	NONE	UNK	UNK		NONE	NONE			1						1	Dizziness; Hyperhidrosis; Insomnia; Pain; Petechiae; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~U1079AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214913	01/15/2004	MD	50.0	50		U	01/12/2004	Temperature about 24 hours, joint ache, headache, right side of neck hurting, injection site left arm.  12/11/03: Developed hoarseness which lasted till 12/25/03 or there about.				Y					Y	12/04/2003	12/10/2003	6	NONE	OTH	OTH	UNK	NONE	Asthma; Eczema; Mitral Valve			1						1	Arthralgia; Dysphonia; Headache; Neck pain; Pyrexia	FLU3~SANOFI PASTEUR~U1271AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214914	01/15/2004	NV	4.0	4		F	01/05/2004	01/02/04: Grandmother reports rash around immunization site.  01/05/04: Grandmother reports better today. Rash about the size of 50 cent coin.									Y	12/31/2003	01/01/2004	1	NONE	PUB	PUB	NONE	NONE	NONE		NV0401	1						1	Injection site rash	FLU3~SANOFI PASTEUR~U1106AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214915	01/15/2004	NV	5.0	5		F	10/29/2003	Reddened 4.5 cm size area on left anterior thigh (round).				Y					Y	10/28/2003	10/29/2003	1	NONE	PVT	PUB	NONE	NONE	NONE		NV0327	1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U1091AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214916	01/15/2004	NV	60.0	60		M	11/06/2003	Injection site-left arm very swollen-twice as big as right arm.  Very high fever: 103.6 - 24 hours after pneumonia injection.									U	11/05/2003	11/05/2003	0		PUB	PVT	NONE	NONE	NONE		NV0329	1						1	Injection site oedema; Pyrexia	FLU3~EVANS VACCINES~765799~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0256N~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0214917	01/15/2004	NV	50.0	60		F	12/09/2003	Erythema, slight edema onset 2 days after flu vaccine, one area that looks like a hive, central area measures 70x125mm.  Hive area 10mm.  LTDT.									Y	11/18/2003	11/19/2003	1	NONE	PUB	PUB	For diabetes, OTC MSM for arthritis	NONE	Last year, flu shot gave a greater, similar reaction, allergy to amoxicillin.	Last year, flu shot gave a greater, similar reaction~Influenza (Seasonal) (no brand name)~~0.00~In Patient	NV0330	1						1	Injection site erythema; Injection site oedema; Urticaria; Vaccine positive rechallenge	FLU3~EVANS VACCINES~765875~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214918	01/15/2004	ND	9.0	9		M	12/03/2003	24 hours after vaccination, right arm site red, swollen, onset of fever and chills which lasted three days.  Injection site developed cellulitis 3inch in diameter.  Tylenol and ice packs used.				Y					Y	10/29/2003	10/30/2003	1	NONE	PVT	OTH	Advair; Nasacort; Clarinex	NONE	Asthma; Allergies to dust, mold, pollen, weeds, dust mites, dogs, cats;			1						1	Cellulitis; Chills; Injection site erythema; Injection site oedema; Injection site reaction; Pyrexia	FLU3~EVANS VACCINES~765668~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0709M~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0214919	01/15/2004	GA	1.0	0	1	M	01/08/2004	2 days after having received an influenza vaccine 0.25mL, the pt developed diffuse facial swelling including eye swelling/ptosis.  No respiratory problems were noted (-) rash, no vomiting/diarrhea.									Y	11/17/2003	11/19/2003	2	Food allergy panel will be done today (01/08/2004)	OTH	PUB	NONE	NONE	Umbilical hernia; intermittent URI's			1						1	Eye oedema; Eyelid ptosis; Face oedema	FLU3~SANOFI PASTEUR~U1239AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215184	01/15/2004	MO	66.0	66		F	01/05/2004	Client reports that she received her influenza vaccine in left arm on 10-28-03 ar Dr. office.  She had previous flu shots other years.. states she got sick on 10-30-03 pm. with vomiting, aching, dizziness and swelling of left arm.  She says there is an indention about 4 below shoulder wherelooks like flesh is out as if from surgery.  She says the area is still hard and swollen.  She still complains of headache and dizziness.  She says she has been back to Dr. office twice for the arm and he x-rayed it on 12-09-03.  she saw Dr. on 12-23-03 and he reported it to the Health Dept.  She gave this information per telephone one 01-05-04 and came to Health Dept. on 01-06-04 to show the arm to nurses.  Says it is painful to raise the arm.  The Dept. of Health & Senior Services will be sending via mail a picture of this arm and possibly the x-ray and lab work that was done on her.				Y					N	10/28/2003	10/30/2003	2	Dr.  office did x-ray 12-09-03.  Blood and lab work done by Dr.  on 12-23-03.	UNK	UNK					MO200403	1						1	Dizziness; Headache; Injection site induration; Injection site oedema; Pain; Vomiting; Dizziness; Injection site induration; Joint range of motion decreased; Pain; Swelling; Vomiting	FLU3~SANOFI PASTEUR~U1103AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1103AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0214944	01/16/2004	FL	67.0	67		M		A male (unknown age) received RSV vaccine or Placebo and Influenza vaccine on 11/6/02 and later died (unknown date). The subject was lost to follow up. The phone was disconnected and certified letter returned with deceased 11/3/03 written on the envelope unopened. Will try and get information from PCP and follow up. Patient has a history of Hypertension, CHF, and back pain. Information from 5/15/03 telephone conversation with the Investigation. A 67 year old male, no family, has tried calling patient's family physician who is not available. The subject was called for follow up, found phone disconnected, then a certified letter was sent which was returned with deceased marked on it. Further information is expected. Follow up information received on 6/5/03. Investigator spoke to subjects doctor on 5/20/03, stated that he did not know his patient had passed away. Doctor does not know what happened or which hospital patient went to. No other information available. Additional information received on 1/12/04. Death certificate. DOB 4/22/35. Subject died on 3/9/03, 123 days post immunization. The state does not release cause of death information. Follow up on 01/21/04 : The death was reported by the investigator as not related to the study vaccine.  Subject died 03/09/03.  Cause of death is unknown. Symptoms and treatment related to the serious adverse events are unknown. Subject had a history of hypertension and congestive heart failure. No further information is available.	Y	03/09/2003							N	11/06/2002	03/09/2003	123		UNK	UNK	Cozaar; Celebrex; Digoxin; Neurontin		HTN; CHF; Back pain - laminectomy		200300660	1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0214946	01/16/2004	MI	4.0			M	01/09/2004	This case was considered medically important (OMIC). Info regarding Flumist was received from a physician regarding a 4 year old male pt who experienced a seizure approximately 26 hrs after receiving Flumist. The pt received a dose on 1/5/04. The physician reported that the child was a walk-up pt and had no history at his office. The physician did not see the child post-immunization, but learned of the seizure after receiving a telephone call from the child's mother. No additional info was available at the time of this report. Follow-up information received from the physician provided a likely diagnosis of febrile seizure and recovery status (patient recovered). The child recovered without sequelae, and was discharged from the emergency room on the same day as admission. The physician spoke with the father the following day, and was told that all was well with the child. Follow up information received from the physician provided a likely diagnosis of febriel seizure and recovery status (patient recovered).				Y					Y	01/05/2004	01/06/2004	1	UNK	PVT	PVT	UNK	NONE	Medical History: The patient has no history of seizures; no known underlying medical problems.		HQWYE171507JAN04	1						1	Febrile convulsion	FLUN3~MEDIMMUNE VACCINES, INC.~500044P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0214947	01/16/2004	GA	15.0	14		M	01/08/2004	Follow up information received from the physician provided patient information, test results and additional events with serious criteria (OMIC). Information regarding Flumist nasal solution was received from a healthcare professional regarding a 14 year old male patient who experienced status asthmaticus, rhinitis, wheezing, headache, sore throat, myalgia and fever. At 14 years of age, the patient received a dose of 12/9/03. The patient's concurrent illness includes asthma. Indication for Flumist was immunization. Product was administered on 12/9/03. Dose regimen was 1 dose (IN). Concomitant therapy included Advair, Singulair, and albuterol. The patient experienced rhintiis, wheezing, myalgia, sore throat, and headache on the night of 12/11/03. On 12/12/03, he was sent home from school with a fever of 101.8 degrees F. He was seen by the physician later that same day with a fever of 102.8 and appeared to have active influenza. He was treated with Advil. Later that same day, he was hospitalized for status asthmaticus. He was treated with prednisone, albuterol, and Tamiflu. On 12/14/03, he was discharged. As of 12/15/03, he was still weak and wheezing but no longer toxic or short of breath. The physician indicated that the patient had been out of albuterol for a few days prior to immunization.					Y	3			N	12/09/2003	12/12/2003	3	Virus culture: negative as of 12/24/03 final results pending	PVT	OTH	Advair, Albuterol, Singulair	NONE	Asthma		HQWYE681817DEC03	1						1	Condition aggravated; Headache; Medication error; Myalgia; Pharyngolaryngeal pain; Pyrexia; Rhinitis; Status asthmaticus; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500016P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0214952	01/16/2004		1.5			F		A report was received from a health care professional on 1/5/03, concerning an 18 month old female vaccinee who experienced a seizure 15 minutes after, and a urinary tract infection an unspecified length of time after inadvertently receiving Fluvirin on an unspecified date. The events were considered medically significant. The vaccinee had a previous history of a seizurre, bronchitis, and mild respiratory distress. On an unspecified date the vaccinee experienced a seizure 15 minutes after receiving Fluvirin at her mother's request on an unspecified date. The vaccinee was taken to an ER for treatment and was diagnosed as having a urinary tract infection. The outcome of the event was not reported. There was insufficient info to determine the reporter's causality assessment. The reporter also commented: doubt seizure was caused by vaccine due to history given by mother.  Follow up on 06/25/04 states: Vaccinee had experienced a seizure prior to Fluvirin administration, was taken to ER and found to have a urinary tract infection and fever. Pt was also found to be developing a fever with the urinary tract infection after vaccination with Fluvirin. The pt is currently being investigated for a seizure disorder unrelated to the Fluvirin event. Reporter's causality-possible, but unlikely.				Y					U					UNK	UNK			Seizure, bronchitis, mild respiratory distress.		PJP200400004	1						1	Convulsion; Urinary tract infection	FLU3~EVANS VACCINES~765484~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0214953	01/16/2004	CO	15.0	15		M	01/06/2004	Pt received flu shot at pharmacy and was told to stay in store 10-15 minutes in case of adverse reaction.  Pt returned about 20 min later; they had left store and pt was passenger in car driving home when pt passed out, but came to almost right away.  Returned to pharmacy for observation.  No further problems.									Y	12/09/2003	12/09/2003	0	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Loss of consciousness	FLU3~SANOFI PASTEUR~U1254AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214954	01/16/2004	CA	3.0	3		F	01/08/2004	Noted redness and swelling surrounding injection site which decreased over next few hours.									Y	01/06/2004	01/08/2004	2	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1149AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0214970	01/16/2004	CO	7.0	7		F	01/14/2004	Stiff neck developed for few days after initial flu vaccine. Booster dose given, pt developed torticollis  worsening over 5 days.				Y					Y	11/29/2003	01/03/2004	35	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Musculoskeletal stiffness; Torticollis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0214971	01/16/2004	PA	21.0	21		F	01/15/2004	Overall body aches and pains.  Slight fever, exhaustion.  Called MD: take 3 advil at HS; Called ER: bring pt to ER if symptoms became worse.									Y	12/29/2003	12/31/2003	2	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Fatigue; Pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500004P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0214972	01/16/2004	PA	9.0	9		M	01/12/2004	Chills, body aches, high fever, runny nose, cough.  Treated with Triaminic flu cold and cough.									Y	12/22/2003	12/25/2003	3	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Chills; Cough; Pain; Pyrexia; Rhinorrhoea; Chills; Cough; Pain; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500004P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500004P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0215230	01/16/2004	IA	60.0	59		F	01/16/2004	Instantly after receiving flu vaccine, patient developed a small rash on her chest.  Within minutes, rash disappeared, no other allergic symptoms.  No Treatment.									Y	12/05/2003	12/05/2003	0	NA	PUB	PVT		Lower back and left sciatic type pain (lumbar laminectomy)	Hypertension, Hyperlipidemia, Osteoporosis, Gastric reflux, Depression			1						1	Rash	FLU3~SANOFI PASTEUR~U1144AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215235	01/18/2004	AR	62.0	61		M	01/18/2004	On the evening of November 24, 2003 client developed a fever of 102.6.  Initially noted clients faced flushed.  Complained of being cold.  No chills, or rash.  Physician called when fever 101.9.  Instructed by on call physician to administer Tylenol.  Client given Acetaminophen 1000mg.  Two hours after medicated, fever had increased to 102.6.  Called physician on call.  Continue to assess client.  If fever reached 103 client was to be seen in the Emergency Room at local hospital.  Other symptoms associated with fever increased respirations, B/P, and pulse rate.  Temperature when client was ready for sleep was 101.9.  Temperature in am 100.  Low grade fever of 99.4-99.8 until afternoon of November 25, 2003.									Y	11/24/2003	11/24/2003	0		UNK	UNK		No active illness	Right hemorraghic CVA 1994 Right LLE DVT  1996 Diabetes Mellitus Adult onset CHF secondary to rebound hypertension			1						1	Blood pressure increased; Feeling cold; Flushing; Heart rate increased; Pyrexia; Respiratory rate increased	FLU3~SANOFI PASTEUR~U1128AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~0287N~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0215238	01/19/2004	CT	62.0	62		M	01/20/2004	first, let me say I do not know if my problem definetly occured due to the Flu shot I received.  Until receiving this years Flu shot I had never before participated in the Flu vaccination program.  Approx. 3 weeks after the shot was administered I contracted ITP. Idiopathic Thrombocytopenic Purpura. My blood platelets were found to be extremely low. According to the Dr. they were at 4000. I spent 3 days in hospital until the Platelets were brought back up to normal capacity. One month prior to receiving the Flu shot my blood platelet count was at 230,000. While in the hospital, Gamma Globulin and Steroids were used to as treatment.                    Have asked Doctor to provide:  1. Name of Vaccine 2. Manufacturer 3. Lot Number 4. Date Flu shot given. The discharge summary received on 3/23/04 states bruises and purpura.				Y	Y	3			Y	12/04/2003	12/18/2003	14	Lab test abnormal	PVT	UNK	Ambien,  Oxycodone.	None	Hypertension, vitiligo, headaches, depression, basal ischemia			1						1	Ecchymosis; Laboratory test abnormal; Purpura; Thrombocytopenic purpura	FLU3~EVANS VACCINES~~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0214598	01/20/2004	CA	60.0			M	01/08/2004	Patient was given a flu shot in the community. The onset of Guillain Barre Syndrome began the following day. Two weeks later, patient admitted to ICU and IVIG administered for two days. Patient improved.				Y	Y	11			Y		11/24/2003			OTH	OTH			NONE			1						2	Difficulty in walking; Guillain-Barre syndrome; Hypoaesthesia; Paraesthesia; Guillain-Barre syndrome	FLU3~EVANS VACCINES~765795~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0215197	01/20/2004	PR	43.0	42		F	10/16/2003	Strong pain in the eye from the front to the posterior part of the head.  Blurry vision, very strong pain.  Went to various specialists fo the eye and an MRI was done.  She was hospitalized for a great inflammation of the optic nerve.			Y	Y	Y	4		Y	U	11/05/1998	11/06/1998	1	Diagnosis: Optic Neuritis, right eye; Treatment: Cortisone IV	PUB	PUB	NONE	NONE	PCN and sulfa			1						1	Eye pain; Headache; Injection site inflammation; Optic neuritis; Vision blurred	FLU3~CONNAUGHT LABORATORIES~09845800~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~448515~UNK~~LA~PNEUMO (PNU-IMUNE)~1|TD~CONNAUGHT LABORATORIES~0908180~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0215201	01/20/2004	PA	59.0	59		M	01/07/2004	Swelling, redness, tenderness, pain left axillary lymph nodes and spread to entire left pectoralis and upper left chest area. Developed initially 2 days after vaccine, progressed for 4 days.									U	12/30/2003	01/02/2004	3	NONE	PVT	PVT	Avandia, Plavix, glucophage, glipizide, Toprol, Lipitor					1						1	Erythema; Oedema; Pain; Tenderness	FLU3~SANOFI PASTEUR~U1123AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1201N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0215202	01/20/2004	NE	26.0	26		F	01/12/2004	Awoke with pain and swelling in arm 12-16 hours later.									N	11/21/2003	11/22/2003	1	NONE	OTH	PUB		NONE	Allergic Veraponil			1						1	Oedema peripheral; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0215203	01/20/2004	CA	49.0	49		F	12/31/2003	Received vaccine in AM after night shift, slept. On waking, fell x2 due to dizziness (like room spinning). Subsided, then vomiting next day due to extreme dizziness (had to hold on to things to walk). Less severe as time passes. Taking Antivert and exercises prescribed by neurologist.				Y					N	10/15/2003	10/15/2003	0	CBC, electrolytes, exams by MD then by neurologist	OTH	OTH	Motrin, BCP, Wellbutrin	NONE	Topical allergies			1						1	Dizziness; Fall; Vomiting	FLU3~EVANS VACCINES~765142~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0215204	01/20/2004	MI	0.58	0	.6	F	01/08/2004	Mom reports infant had immunizations approx 3-4 PM at HD. Infant started getting fussy and had a low grade fever approx 10 AM. Mom reports by 2 PM infant had hives all over her body and difficulty with breathing so mom took infant to ER. Baby had temp of 101 and was vomiting. Baby was at ER 6 hours after 10 PM. Mom states baby got PO Benadryl and oral pedialyte. No IV. Mom states infant has been referred to a pediatric allergist on 3/8/04 to rule out egg allergy per mom. The medical record received on 2/2/04 states decreased appetite.				Y					N	12/17/2003	12/18/2003	1		PUB	PUB	NONE	NONE	NONE			1						1	Decreased appetite; Dyspnoea; Irritability; Pyrexia; Urticaria; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~21912A2~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1108AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0254N~3~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~494310~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0215221	01/20/2004	WA	0.6	0	.6	F	01/16/2004	Mother states spit up feeding later on evening after injection.  Not vomiting, is taking fluids.  Both thighs, no swelling, no redness at site of injection.  NO fever.  Is drinking well, states did spit up 2 times after 1st time the following day.				Y					Y	01/15/2004	01/15/2004	0	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Vomiting	DTAP~SANOFI PASTEUR~C1387AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1232BA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE012AA~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~493506~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0215240	01/20/2004		78.0	78		M		A report was received from a health care professional on 1/8/04 concerning a 78 year old male vaccinee who developed a rash and fever and was diagnosed with Stevens Johnson Syndrome on 11/02/2003 and hospitalized on the same day, after receiving Fluvirin vaccine on 10/29/03. Concomitant medications included phenytoin, amlopidine besilate and lisinopril which were commenced two months prior to hospitalization. On 11/02/03, the vaccinee, who is a lung cancer patient, developed a rash, fever, and was admitted to hospital on the same day and diagnosed with Stevens Johnson Syndrome. Skin biopsy results of the left chest were determined to be consistent with erythema multiforme. The vaccinee also experienced erythema of the conjuctiva and erythema with palmar involvement. The vaccinnee was treated with topical and systemic corticosteroids. The vaccinee recovered and was discharged from hospital on approximately 11/11/03. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Follow up on 04/29/04 states: Further information was received from a health care professional indicating that the vaccinee experienced erythema multiforme and erythema with palmar involvement on 10/30/03.  On 11/03/03 the vaccineee underwent a skin biopsy on 0.4cm of a conical piece of skin of the left chest, which was consistent with erythema multiforme.  The epidermis revealed minimal spongiosis, necrotic keratinocies, exocytosis and focal vasuolar degeneration in the basal cell layer. On 10/29/03 the vaccinee visited a center and the attending physician reported that he had a superficial skin reaction on his scalp due to radiation therapy. The vaccinee has no known allergies. The vaccinee has a medical history of non-small cell lung cancer-metastatic lung adenocarcinoma with metastases in the brain and adrenal glands. A brain lesion was subsequently diagnosed in Sept 03. The vaccinee also has a  history of seizure, hypertension and coronary artery disease and underwent CABG surgery on an unspecified date. The vaccine had a radiation therapy with palliation of the brain metastasec from 10/03/03 -010/24/03.  Concomitant medication included phenytoin sodium for seizure, dexamathosone and bran metastases, simvastatin, acetylealicyclic acid for coronary artery disease and trazodone.  The vaccinee's dermatologist was consulted and he was treated with hydrocortisone cream to be administered twice a day to the face.  The vaccinee was also treated with an increase of dexamethalosone, dexamethssone eye drops and cefatolin. Phenytoin was discontinued. The reporter has assessed the relation ship of the vaccinee to the erythema multiforme with palmar involvement and fever as possible, although stating that the vaccinee was also taking phenytoin sodium at the time of the event. Follow up pending. Follow up on 05/17/04 states: No new information at this time.					Y				Y	10/29/2003	11/02/2003	4	Skin biopsy of left chest (11/03/03): Consistent with erythema multiforme;	UNK	UNK	Phentoin, Norvasc, Lisinopril		Lung cancer		pjp200400056	1						1	Erythema multiforme; Pyrexia; Rash; Stevens-Johnson syndrome	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0215241	01/20/2004	WA	31.0	31		F		Difficulty breathing. Two 25mg Benadryl.									Y	01/02/2004	01/02/2004	0		OTH	OTH		NONE	Zithromax allergy			1						1	Dyspnoea	FLUN3~MEDIMMUNE VACCINES, INC.~500034P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0215260	01/21/2004	CA	37.0	36		F	01/09/2004	Pt complained of flu shot given to high in left arm.  After leaving flu clinic, severe pain began with inability to move arm or use fingers also felt nauseated with pain.  Currently still having left shoulder pain, limiting use of left arm.									U	12/02/2003	12/02/2003	0	NONE	PUB	PUB	NONE	NONE	Sarcoinosis;			1						1	Hypokinesia; Nausea; Pain; Shoulder pain	FLU3~EVANS VACCINES~765141~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0215261	01/21/2004	MI	4.0	4		M	12/22/2003	12/19/03: Friday at approximately 7pm, pt exhibited congestion, cough, fever-temperature unknown, and body aches, relieved with children's Motrin for cold, then intermittent relieved by more children's Motrin.  He's improving, but his fever is up and down.  Flu shot given Friday at 15:30.  Still febrile, recovering.				Y					Y	12/19/2003	12/19/2003	0	MD visit: Fevers gone 12/22/03, and diagnosis: Bronchitis.  Not related to flu shot per mother.  Pt has prescription for bronchitis.	PUB	PUB	Once symptomatic: Children's Motrin; Erythromycin Ointment to eye;	Pink eye (left eye)	NONE		MI2003070	1						1	Bronchitis; Cough; Nasal congestion; Pain; Pyrexia	FLU3~EVANS VACCINES~765980~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0215262	01/21/2004	NE	1.3			F	01/20/2004	Fever, seizure (grand mal) 01/16/04.  Shots 01/12/04 (DTAP, IPV, MMR, FluZone).  Nurse follow up on 06/18/04 states: ADD: cough, runny nose, fussy, screaming.				Y					Y	01/12/2004	01/16/2004	4	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Cough; Grand mal convulsion; Irritability; Pyrexia; Rhinorrhoea	DTAP~SANOFI PASTEUR~C1612AA~4~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1170AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X0316~3~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0679N~1~SC~LL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA	Emergency room visit	Influenza
0215263	01/21/2004	MI	2.1	2	.1	M	12/23/2003	Received 1st dose ever of flu vaccine on Tuesday 12/16/03 09:30.  Mom noticed hives, Wednesday AM 07:30 12/17/03 on torso only.  Looked reddish in color with blister like center.  But fades to nothing.  When pt gets warm, hives come out again by Friday, hives appearing on hands, face and legs also.  Called PMD, was told not a reaction to flu vaccine.  Could give Benadryl.  Did give Benadryl every 6-8 hours since then.  As of 12/23/03 PM, still had a few hives outbreak with cool bath this AM.									N	12/16/2003	12/17/2003	1	NONE	PUB	PUB	Has inhalers as needed for asthma.  Not used since 09/2003	NONE	Asthma; Hypersensitive skin (mom uses dye free soaps);		MI2003069	1						1	Blister; Erythema; Urticaria	FLU3~SANOFI PASTEUR~U1108AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215264	01/21/2004	MA	39.0	39		M	11/19/2003	Had shots last Thursday, now today his jaw is swollen.  Both sides are affected and also forehead pressure symptoms started today.  Noticeable edema not painful.									Y	11/06/2003	11/18/2003	12	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Oedema; Sensation of pressure	FLU3~SANOFI PASTEUR~U1131AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0152N~1~IM~RA~HEP A (VAQTA)~1|MMR~MERCK & CO. INC.~0665N~2~SC~LA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|TYP~SANOFI PASTEUR~W13443~1~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0215265	01/21/2004	IN	35.0	35		F	12/15/2003	Seen in employee health 12/12/03: states took flu 12/10 achy 12/11, took Motrin off and on 12/12.  Started itching upper extremities and back.  Noticed rash on neck and upper back. Complained of burning, tingling and itching.  No respiratory distress, took Benadryl 25mg per mouth earlier.  Exam-slight rash noted at deltoid region.  Red rash noted upper back.  12/15/03: Reports resolved 12/13/03 PM.									Y	12/10/2003	12/11/2003	1	Given Benadryl 25mg per mouth every 4 hours.	PVT	PVT	NONE	NONE	Droperidol;			1						1	Erythema; Paraesthesia; Pruritus; Rash; Skin burning sensation	FLU3~EVANS VACCINES~765790~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0215307	01/21/2004	MD	56.0	56		F		Within 4 hours of vaccine fever 102 degrees, chills, voice hoarse, incentive spisometry 2500 prevaccine, decreased 1500-on 01/06/04.				Y					N	11/25/2003	11/25/2003	0	Chest x-ray: Pneumonia;	PVT	OTH	NONE	NONE	NONE			1						1	Chills; Dysphonia; Laboratory test abnormal; Pneumonia; Pyrexia	FLU3~EVANS VACCINES~766052~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0191556	01/22/2004	AZ	26.0	26		F	01/17/2003	From initial correspondence received via fax on 10/18/02, it was reported that a 26 year old female patient was vaccinated with Fluzone on 10/14/02 IM in the left deltoid. The patient reported awakening from a sound sleep at 11:30PM on 10/14/02 and being unable to breathe. This was followed by an episode of coughing, shakiness, dizziness, disorientation, blurred vision, and later vomiting. She believes this might be related to Fluzone influenza vaccine received almost 12 hours earlier. The patient denies fever, rash, facial or upper airway swelling, abdominal pain/cramping, or diarrhea. There has been no recent illness among family members, or variation in food consumed by them as a group. At present, patient describes feeling worn out, but denies any respiratory distress. The responsible physician's assessment states, evolving sensitization versus delayed hypersensitivity response to unknown substance. Whereas serious adverse reaction to vaccines can produce similar respiratory symptoms, a delay of almost 12 hours seems unlikely. I am more likely to suspect the possibility of individual or synergistic response to one or both recently introduced Clarinex and Vitamin/Herbal Stimulant, the former of which is an unregulated product containing quite a number of plant products of undetermined concentration. It is noted that no ephedrine content is noted. The employee is advised to contact her PCP today to discuss any change in her current medical/supplement regimen, and guidance regarding the advisability of future vaccination.									Y	10/14/2002	10/14/2002	0	ENT: ENC are clear, TM WNL bilaterally; Tonsils moderately enlarged L>R but without exudates, cervical nodes benign. Cardiac - RRR without murmur gallops. Chest: unlabored respirations, 14 minutes, chest wall expansion is symmetric without diaphragmatic excursion. Land fields are clear without advenitious sounds.	MIL	PVT	Clarinex; Sansome Dietary Supplement; Multivitamin	NONE	Patient is negative for major health problems, asthma, allergic reaction to meds, eggs, or latex. She is not pregnant.		U200200876	1						2	Cough; Disorientation; Dizziness; Dyspnoea; Fatigue; Laboratory test abnormal; Tonsillitis; Tremor; Vision blurred; Vomiting	FLU3~SANOFI PASTEUR~U0968A2~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0191920	01/22/2004	TN	46.0	46		F	10/31/2002	From initial info received via telephone on 10/7/02, it was reported that a 46 year old female had been vaccinated with Fluzone (U0872AB) on 10/4/02 at 5 pm in the left deltoid. The following morning, the local site was approximately 2 inches in diameter, red and swollen. Within 24 hrs of receipt of the dose, the pt experienced nausea, diarrhea, excessive sweating, chills and rigors. On 10/7/02, it was reported that the injection site was red, swollen, tender to touch, now approximately 6 inches in diameter. This is the first time this person has ever had any local reaction to flu vaccine in 20 years.									U	10/04/2002	10/05/2002	1		OTH	OTH					U200200808	1						2	Chills; Diarrhoea; Hyperhidrosis; Injection site erythema; Injection site oedema; Injection site pain; Nausea	FLU3~SANOFI PASTEUR~U0872AB~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0191997	01/22/2004		33.0	33		F	12/13/2002	It was reported by a nurse that a 33 year old female was vaccinated with a dose of Fluzone *U0966BA) on 10/15/02 in the deltoid. She experienced temporary blindness in her right eye the evening of her vaccination. She was seen by her opthalmologist and Medrol pack was prescribed. According to the reporter, the physician feels its vaccine related. Last year she experienced the same event 2 weeks after she received a dose of Fluzone. The event lasted on and off for several months. She did not report the event because at that time it was not attributed to the vaccine. It was not reported whether the pt recovered.				Y					U	10/15/2002	10/15/2002	0		OTH	OTH				Abnormal vision~Influenza (Seasonal) (Fluzone)~~32.00~In Patient		1						3	Blindness transient; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U0966BA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Emergency room visit	Influenza
0192072	01/22/2004	VA	39.0	39		M	05/30/2003	From information received via fax on 10/24/02, it was reported that a 39 year old male patient received Fluzone on 10/23/02 in the left deltoid at 10:00 AM. The patient called the vaccine administrator and reported that on 10/23/02, at 5:00 PM, he experienced a temperature of 102 degrees, chills, and body aches that began approximately six hours after the vaccine was given. He was referred to his primary care physician. It was not known if the patient recovered. From additional information received on 4/14/03 from a nurse, it was reported that the patient saw his personal care physician and recovered from the events. Reviewed, no additional information at this time. No further information is anticipated, this case is closed.				Y					Y	10/23/2002	10/23/2002	0		OTH	OTH		NONE	NONE		U200200885	1						2	Chills; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U0922AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0192259	01/22/2004	GA	43.0	43		F	02/27/2003	From fax correspondence received on 10/31/02, it was reported that a 43 year old adult female was vaccinated with Fluzone (lot # 40924DA) on 10/16/02. That day she developed soreness and weakness in left arm. Reportedly she recovered. Case is closed.									Y	10/16/2002	10/16/2002	0		PVT	PVT					U200200934	1						2	Hemiparesis; Pain	FLU3~SANOFI PASTEUR~40924DA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0192271	01/22/2004	GA	31.0	31		F	02/27/2003	From fax correspondence received at manufacturer on 10/31/02, it was reported that a 31 year old adult female was vaccinated with Fluzone SV 2002-2003 USP (Lot # 40924DA) on 10/16/02.  The same day she developed nausea, vomiting, dry heaves, and tachycardia. Symptoms resolved the next morning at 5am.  Pt noted similar reaction from previous hepatitis B vaccination with questionable hypersensitivity to the preservative component. See case # U2002-00934 with the same reporter.									Y	10/16/2002	10/16/2002	0		PVT	PVT	UNK	UNK	UNK	Tachycardia~Hep B (no brand name)~~0.00~In Patient	U200200937	1						2	Nausea; Retching; Tachycardia; Vomiting	FLU3~SANOFI PASTEUR~40924DA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0193007	01/22/2004	CO	58.0	58		F	12/13/2002	A report received concerning a 58 year old female administered with Fluzone (U0920AA) IM in the left arm on 11/7/02 at 3:05 pm. It was reported, Pt received her flu shot prior to her appointment for a screening mammography. She has received flu shots yearly without problems. During her mammogram procedure, she suddenly felt lightheaded and nauseous. Thought she was going to get sick. She sat for a few minutes, drank some juice and then felt better. Client did not appear to be anxious about mammogram. Vital signs were normal. Spoke to pt today 11/10, she is feeling fine. Denies any symptoms or adverse affects today. VAERS form submitted due to the sudden onset on feeling lightheaded and nausea. The case is closed.									Y	11/07/2002	11/07/2002	0	NONE	PUB	PVT		NONE	UNK		U200201057	1						2	Dizziness; Nausea	FLU3~SANOFI PASTEUR~U0920AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0193008	01/22/2004	CO	39.0	39		F	12/13/2002	A VAERS report received from hospital concerning a 39 year old female administered with Fluzone (U0920AA) IM in the right arm on 11/7/02. It was reported, Pt received her flu shot, then her daughter received her shot. They sat in the lobby for 15-20 minutes due to first time flu shot for her daughter. They had checked back in with the nurse and were released to go. They were outside when she suddenly had chest discomfort/ tightness, began to sweat and become very nauseated. 911 called, client evaluated 12-lead EKG negative, released to go home. Spoke to client today 11/10, she stated that yesterday she develop a rash on her left shoulder and back, the rash later disappeared and she developed some swelling to the left side of her neck and burning sensation in her left shoulder. She still has the burning sensation slightly today and mild swelling in her neck. Denies any chest discomfort. Client has received flu shots in 2001 & 2000 without problems. Denies feeling ill that day, no allergies to eggs. The pt has been taking Naicin 500mg daily, Lasix, vitamin B & E, Ginko, grapeseed extract & CoEnzyme 10 for 10 years.				Y					N	11/07/2002	11/07/2002	0	Client evaluated 12-Lead EKG negative	PUB	PVT	Naicin 500mg daily, Lasix, vitamin B & E, Ginko, grapeseed extract & CoEnzyme 10 for 10 years.	NONE	Meniere's disease		U200201054	1						2	Chest discomfort; Hyperhidrosis; Nausea; Oedema; Rash	FLU3~SANOFI PASTEUR~U0920AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0193009	01/22/2004	CO	29.0	29		F	03/01/2003	A VAERS report received from hospital concerning a 29 year old female administered with Fluzone (U0920AA) IM in the left arm on 11/7/02. It was reported, 1.5 hrs after receiving her flu shot she develped sudden tingling and numbness in her chin and lower jaw. No hives or rash. No symptoms of throat swelling. No hoarseness or wheezing. Symptoms isolated to her jaw. Spoke with client today 11/10. She is doing fine symptoms are gone. They lasted for several hours after her flu shot. She last had a flu shot 4 years ago. This case is closed.									Y	11/07/2002	11/07/2002	0	NONE	PUB	PVT		NONE	NONE		U200201055	1						2	Hypoaesthesia; Paraesthesia	FLU3~SANOFI PASTEUR~U0920AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0193035	01/22/2004	CO	73.0	73		F	12/13/2002	A VAERS report received from hospital concerning a 73 year old female administered with Fluzone IM in the right right arm 11/7/02. It was reported, Call center RN was conducting a call back on her husband who had received a flu shot and had complained of tingling/ pain in his arm, he has MS. (Adverse form not submitted). During the conversation, the pt had indicated that his wife had not felt well after her flu shot. Information related as follows to RN. 24 hrs after receiving her flu shot, the pt stated she had bumps on the base of her tongue and a strange feeling in her throat and the roof of her mouth. States she very much felt like something was wrong. Call back took place on 11/7/02, the pt stated at that time her symptoms were gone. Attempted to reach client 11/10/02 unsuccessfully. Successfully reached the client today. In reviewing her symptoms she indicated that she had itching on her back on the evening of 11/6/02, they were gone by the morning of 11/7. Approximately around 8am on 11/7, as they were driving, her throat suddenly became scratchy and tight, denies difficulty breathing or swallowing. She drank water, took a mint to help but she felt like something was caught in her throat, she felt like she needed to clear her throat frequently. She was frightened and almost turned back. Eventually the symptoms disappeared but came back later that night. Today her throat is still a little scratchy but is able to drink and talk without difficulty. On 11/7, she was advised to take Benadryl, which she did and it helped. Advised client to call if symptoms became worse or to call 911 if her throat feels tight. This was her first flu shot. She denies an allergy to eggs, but the smell of eggs nauseates her. She received a pneumonia vaccine one year ago without problems. The pt takes several medications but unspecified. The case is closed.									U	11/06/2002	11/07/2002	1		PUB	PVT			Allergy: Valium, Darvon, Iodine.		U200201056	1						2	Pruritus; Throat tightness; Tongue disorder	FLU3~SANOFI PASTEUR~U0920AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0193327	01/22/2004	MD	46.0	46		M	05/30/2003	From correspondence received via fax on 11/11/02, it was reported that a 46 year old male patient received FLUZONE, lot number U0904CA, in the left deltoid on 11/1/02 at 9:30 am. Patient experienced generalized rash, itching, and swelling on 11/2/02 sometime in the morning. Was seen in the emergency department on 11/3/02 at 3:00 am, was treated with steroids and Benadryl. Patient was also treated with secondary steroids for esophagitis. Followed up with family doctor on 11/5/02 and 11/6/02. The patient was still experiencing itching and rash, and also complained of muscle and joint aches. The patient did not recover. From additional information received on 4/14/03 from the physician assistant, it was reported reviewed no additional information at this time. No further information is anticipated, this case is closed.				Y					U	11/01/2002	11/02/2002	1		OTH	PVT		NONE	NONE			1						2	Arthralgia; Myalgia; Pruritus; Rash; Swelling	FLU3~SANOFI PASTEUR~U0904CA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0194115	01/22/2004	AK	59.0	59		F	11/11/2002	From initial correspondence received via fax on 10/11/02, it was reported that a 59 year old female patient had been vaccinated with Fluzone and a pneumococcal vaccine on 10/4/02. Both vaccines given in the left deltoid. Patient developed a swollen, red area the size of a grapefruit in the left arm on 10/4/02. Additionally, she had a fever. The patient went to clinic on 10/5/02 and saw PNP. She was diagnosed with sterile cellulitis and was given antibiotics (unspecified). GNP felt the reaction was probably the result of the vaccine being given SC instead of IM. The patient called the administering office on 10/7/02 to notify them of her reaction. Per the FNP, attempted to call; message left. I used a 5/8 needle to give an IM injection. Patient frail, elderly with small size. Reportedly, the patient recovered.				Y					Y	10/03/2002	10/04/2002	1		PUB	PUB			NONE		U200200848	1						2	Cellulitis; Erythema; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U0885AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1161L~2~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0194578	01/22/2004	TX	56.0	56		F		It was reported that a 56 year old female pt was vaccinated with first dose of Fluzone (U0958AA) given in the left deltoid on 11/13/02. Approximately 10 minutes after vaccination, the pt complained of wave-like feeling insider her body and a need to clear her throat. Several days later, she experienced cold chills, perspiration and feeling of water in her lungs with difficulty breathing off and on. The pt reportedly recovered from these reactions. The pt had no illnesses at time of vaccination. It was not known whether or not the pt had any pre-existing diagnoses at time of vaccination. No lab/diagnostic tests were taken at time of vaccination.									Y	11/13/2002	11/13/2002	0	NONE	OTH	OTH		NONE	NONE		U200201154	1						2	Chills; Dyspnoea; Hyperhidrosis; Lung disorder	FLU3~SANOFI PASTEUR~U0958AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0194579	01/22/2004	TX	52.0	52		M	02/21/2003	It was reported that a 52 year old male pt received first dose of Fluzone (U0913AA) given in the left deltoid on 11/4/02. The pt experienced a sore arm, dull aches for four days after injection, along with chill off and on, body aches, flu-like symptoms, little energy and feeling hot intermittently. On 11/28/02 and 11/29/02, the pt experienced heavy sweating, stomach cramps. He was unable to eat from 11/29/02 to 12/1/02. He reportedly felt better by 12/3/02 and recovered from these reactions. The pt had a heart attack in January of 1998, and is taking Glucovance. He had no other illnesses at time of vaccination and no lab/diagnostic tests were taken.									Y	11/04/2002	11/08/2002	4	NONE	OTH	OTH	Glucovance	NONE	Heart attack in January of 1998.		U200201152	1						2	Abdominal pain; Asthenia; Decreased appetite; Feeling hot; Hyperhidrosis; Influenza like illness; Pain; Tenderness	FLU3~SANOFI PASTEUR~U0913AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0194834	01/22/2004	IA	91.0	91		F	05/30/2003	It was reported that a 91 year old female pt was vaccinated on 10/30/02 at 9am with Fluzone (U0918AA) IM in the left deltoid. Pt had a rash and hives on her buttocks on the morning of 11/2/02. No lab/diagnostic tests were taken and no other vaccines were given. No adverse events following prior vaccination were reported. The pt did not recover. From additional info received on 4/14/03 from the reporting physician, it was reported that the pt had no illness at time of vaccination and current condition is stable. She had her rash for several weeks, but rash finally cleared up and has not returned. Still no other med changes. No further info is anticipated, the case is closed.									Y	10/30/2002	11/02/2002	3	NONE	OTH	PVT	Avandia, Spironolactone, vitamin, Atenol, Imdur, synthroid, ASA, Lasix, Pepcid, Nitro patch, Aricept, Micronase, Tamoxifen	NONE	Diabetes, heart disease and congestive heart failure		U200201077	1						2	Rash; Urticaria	FLU3~SANOFI PASTEUR~U0918AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0215349	01/22/2004	FL	66.0	65		M		Guillain Barr Syndrome. Persisting numbness in feet- Tires easily.			Y						N	11/01/1995	03/06/1996	126		UNK	UNK	Coremadin	NONE	Replacement of heart valve.			1						1	Fatigue; Guillain-Barre syndrome; Hypoaesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0215351	01/22/2004	NC	1.2	1	.2	M	01/15/2004	Mother reports hives approximately 30 hours later.  Legs, some trunk, arms-child asleep at time.  Mother noted hives-says 70% better next AM.  No prescription.  Did not call child's pediatrician.  No respiratory problems per mother.									Y	12/10/2003	12/11/2003	1	NONE	PUB	PUB	NONE	NONE	NONE		NC04004	1						1	Urticaria	FLU3~SANOFI PASTEUR~U1112AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215352	01/22/2004	OK	51.0	51		F	01/13/2004	Nauseous, shaky approximately 2 hours, no treatment.									Y	12/11/2003	12/11/2003	0	NONE	PVT	PVT	Protonics; Bextra; Synthroid; Lopressor;	NONE	Hypertension; Esophagitis; Low thyroid;			1						1	Nausea; Tremor	FLU3~SANOFI PASTEUR~U1149AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215353	01/22/2004		18.0	18		M	01/07/2004	Pt had brief syncopal episode immediately following completion of 3 vaccinations (Hep A, Typhoid, Flu shot) at around 10:30.  Pt was brought to ER for observation and treatment.  Pt received 1 liter of NS and released once recovered.  At 11:30 Temperature 98.5, pulse 79, RR 19, BP 119/76, Sat O2 98%.  At 15:00 Temperature 98.7, pulse 85, RR 16, BP 125/63, Sat 96%.				Y					Y	12/31/2003	12/31/2003	0	EKG: NSR with blocked premature atrial complex otherwise normal EKG.	MIL	MIL	NONE	NONE	NONE			1						1	Blood pressure decreased; Syncope	FLU3~SANOFI PASTEUR~U1133AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0086N~2~IM~RA~HEP A (VAQTA)~1|TYP~SANOFI PASTEUR~W13662~1~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0215354	01/22/2004	MI	3.0	3		M	01/13/2004	Pt received flu vaccine at approximately 13:30 on 01/13/04.  Mom returned to office at 16:00-child had 2 hives on right thigh 4x3cm and a c shaped hive approximately 2.5cm where shot was administered.  Also 1 hive on right check 1.5x1.5cm.  Benadryl 12.5mg administered per mouth.  Mom to give every 6 hours.									Y	01/13/2004	01/13/2004	0	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1170AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215355	01/22/2004	MO	55.0	54		F	12/10/2003	Left arm noted increased swelling after 12-24 hours after shots, elbow to shoulder.  Hot and tender.  Now states itching.									U	11/13/2003	11/14/2003	1	States get hives frequently.	PVT	PVT	Clonopine; Amytriptyline; Flexoril; Propanalol;	NONE	Fibromyalgia; Restless leg syndrome; Sleep disturbances;			1						1	Injection site oedema; Injection site pain; Injection site warmth; Pruritus	FLU3~EVANS VACCINES~765502~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~776C6~2~IM~LA~HEP A (HAVRIX)~1|PPV~MERCK & CO. INC.~0947N~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0215356	01/22/2004	NV	59.0	59		F	01/12/2004	Within 3 days left arm began to swell and turn blotchy red with some bumpy (hive-like) areas.  Under left arm-swollen glands.									Y	12/01/2003	12/03/2003	2	NONE	PUB	OTH	NONE	NONE	NONE			1						1	Erythema; Lymphadenopathy; Oedema; Urticaria	FLU3~SANOFI PASTEUR~U1091AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0819M~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0215357	01/22/2004	OK	0.11	0	.9	F	01/13/2004	Sweaty, runny nose, cough and fever. The ER summary received on 2/9/04 states short of breath, croup, stridor, vomiting, otitis, wheezing and viral pneumonia.				Y					Y	12/11/2003	12/18/2003	7	Flu test: (+) type A; RSV: Negative, chest x-ray lab work;Chest x-ray positive.	PVT	PVT	NONE	NONE	Cardiomegaly			1						1	Cough; Dyspnoea; Hyperhidrosis; Influenza; Laboratory test abnormal; Laryngitis; Otitis media; Pyrexia; Rhinorrhoea; Stridor; Viral infection; Vomiting; Wheezing	FLU3~SANOFI PASTEUR~U1149A~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215358	01/22/2004	OK	25.0	25		F	01/13/2004	Dizzy, shaky, trouble breathing, flushed. BP 120/86, heart pounding.  Treatment: Benadryl and inhaler.				Y					Y	12/11/2003	12/11/2003	0	NONE	PVT	PVT	Qvar; Ventolin inhaler;	NONE	Allergies: Motrin; Asthma;			1						1	Dizziness; Dyspnoea; Flushing; Palpitations; Tremor	FLU3~SANOFI PASTEUR~U1149AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215359	01/22/2004	AZ	2.0	2	.8	M	01/16/2004	1 day after right thigh erythemic, itchy, slightly raised 5x6cm area.  Benadryl and Augmentin.  PCV 7 #3.									U	01/12/2004			NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site swelling; Pruritus	FLU3~EVANS VACCINES~765705~UNK~~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~MERCK & CO. INC.~0739N~UNK~~LL~HEP A (VAQTA)~1|PNC~PFIZER\WYETH~494381~UNK~~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0215360	01/22/2004	MO	56.0	56		M	12/05/2003	Pt had a flu shot and 20 minutes later got sudden hot flash and felt heart racing.  Instructed him to follow up with his physician.									Y	12/05/2003	12/05/2003	0	NONE	PUB	PVT	New-Digixon; thyroid;	NONE	NONE			1						1	Heart rate increased; Hot flush	FLU3~EVANS VACCINES~766050~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0215361	01/22/2004	AZ	1.7	1	.6	M	01/07/2004	Some redness and little swelling on left deltoid, painful.  Apply warm compress then cold pak RTC if not improve.									Y	01/05/2004	01/07/2004	2	NONE	PUB	PUB	NONE	NONE	PCN			1						1	Injection site erythema; Injection site oedema; Injection site pain	DTAP~SANOFI PASTEUR~U1007BA~UNK~IM~~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1109AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215397	01/22/2004	CO	49.0	49		F	04/15/2003	It was reported that a 49 year old female was administered Fluzone SV 2002-2003 USP (Lot # U0934BA) on 11/15/02.  Three hours after vaccination, the pt had swelling in the calves and legs.  The area from the ankle to the knee was bright red and the area from the knee to the thigh was blotchy red.  The pt also complained of extreme itchiness and burning pain in calves.  She was seen in the ER on 11/17/02 and diagnosed with vasculitis.  The treatment included IV antibiotics, IV steroids, and IV Benadryl.  She was released with oral steroids for 10 days and referred to her dermatologist.  From additional information received from the manufacturer on 04/14/03, it was reported that the pt was given Fluzone SV 2002-2003 USP vaccination in the left deltoid at 3:00PM on 11/15/02.  Pt experienced symptoms of Vasculitis three hours later on the same day.  Pt was seen in the ER on 11/17/02.  CBC, Sed. Rate, Cardiac Enzymes and Renalytes were drawn but the only abnormal lab was elevated Sed. Rate.  It was also reported that the pt, in the past, had received numerous flu shots and would get them annually.  Pt was taking Ibuprofen for an unrelated condition.  And in September 2002, pt was given Pneumovax at a doctor's office.  Pt was healthy at the time of vaccination.				Y					Y	11/15/2002	11/15/2002	0	CBC, Sed. Rate, Cardiac Enzymes and Renalytes done in ER.  Only abnormal lab was elevated Sed. Rate (not reported)	PUB	PVT	Ibuprofen;	Healthy	Was given Pneumovax in 09/02 at MD office.		U200201045	1						1	Erythema; Laboratory test abnormal; Oedema; Oedema peripheral; Pain; Pruritus; Rash macular; Red blood cell sedimentation rate increased; Skin burning sensation; Vasculitis	FLU3~SANOFI PASTEUR~U0934BA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215398	01/22/2004	WY	48.0	48		F	04/21/2003	From initial info received on 10/18/02, seven female employees were vaccinated on 10/15/02 and 10/17/02 with Fluzone. They experienced local reactions of redness, swelling and itching 24 hrs post vaccination. The facility physician prescribed Tylenol. From additional info received on 11/4/02 via fax from the reporter, four of the seven employees have been identified. Pt two is a 48 year old female who received a Fluzone (U0968AA), administered IM in the left deltoid on 10/15/02 at 2 pm. Reportedly two hours later the pt experienced an edematous left arm, red from top to elbow, hot to the touch and painful; chills with headache that lasted 24 hrs. The pt reportedly recovered from these events.									Y	10/15/2002	10/15/2002	0	NONE	PUB	PUB	Multivitamin, Evista, Calcium, Aspirin				200300072	1						1	Chills; Headache; Injection site erythema; Injection site oedema; Injection site warmth; Oedema peripheral	FLU3~SANOFI PASTEUR~U0968AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215399	01/22/2004	CT				F	05/19/2003	From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA). Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.									U				Positive for influenza type A.	OTH	OTH					200300338	1						1	Influenza; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U0906AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215400	01/22/2004	CT				M	05/19/2003	From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA). Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.									U				Positive for influenza type A.	OTH	OTH					200300339	1						1	Influenza; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U0906AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215401	01/22/2004	CT				F	05/19/2003	From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA). Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.									U				Positive for influenza type A.	OTH	OTH					200300340	1						1	Influenza; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U0906AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215402	01/22/2004	CT				F	05/19/2003	From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA). Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.									U				Positive for influenza type A.	OTH	OTH					200300341	1						1	Influenza; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U0906AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215403	01/22/2004	CT				F	05/19/2003	From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA), on an unspecified date. Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.									U				Positive for influenza type A.	UNK	UNK					200300342	1						1	Influenza; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U0906AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215404	01/22/2004	CT				F	05/19/2003	From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA), on an unspecified date. Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.									U				Positive for influenza type A.	OTH	OTH					200300343	1						1	Influenza; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U0906AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215405	01/22/2004	CT				U	05/19/2003	From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA), on an unspecified date. Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.									U				Positive for influenza type A.	UNK	UNK					200300344	1						1	Influenza; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U0906AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215406	01/22/2004	CT				M	05/19/2003	From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA), on an unspecified date. Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.									U				Positive for influenza type A.	UNK	UNK					200300345	1						1	Influenza; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U0906AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215407	01/22/2004	CT				F	05/19/2003	From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA), on an unspecified date. Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.									U				Positive for influenza type A.	OTH	OTH					200300346	1						1	Influenza; Laboratory test abnormal	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215408	01/22/2004	CT				F	05/19/2003	From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA), on an unspecified date. Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.									U				Positive for influenza type A.	OTH	OTH					200300347	1						1	Influenza; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U0906AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215409	01/22/2004	CT				M	05/19/2003	From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA), on an unspecified date. Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.									U				Positive for influenza type A.	OTH	OTH					200300348	1						1	Influenza; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U0906AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215410	01/22/2004	CT				F	05/19/2003	From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA), on an unspecified date. Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.									U				Positive for influenza type A.	OTH	OTH					200300349	1						1	Influenza; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U0906AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215411	01/22/2004	CT				M	05/19/2003	From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA(, on an unspecified date. Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.									U				Positive for influenza type A.	OTH	OTH					200300350	1						1	Influenza; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U0906AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215412	01/22/2004	CT				M	05/19/2003	From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA), on an unspecified date. Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.									U				Positive for influenza type A.	OTH	OTH					200300351	1						1	Influenza; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U0906AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215413	01/22/2004	CT				F	05/19/2003	From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA), on an unspecified date. Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.									U				Positive for influenza type A.	OTH	OTH					200300352	1						1	Influenza; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U0906AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215414	01/22/2004	CT				F	05/19/2003	From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA), on an unspecified date. Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.									U				Positive for influenza type A.	OTH	OTH					200300353	1						1	Influenza; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U0906AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215415	01/22/2004	NY	48.0	48		F	09/19/2003	From initial info received on 8/21/03 from a health care professional regarding an adverse event, it was reported that a 48 year old female pt received Fluzone (I0906AA), administered IM in the left arm on 12/19/02. 33 days later, on 1/21/03, the pt developed pain and limited movement in the left arm. She was seen by an orthopedist and consulted an infection disease specialist. An MRI done on 3/25/03 showed tendonitis. At the time of this report, the pt continued to experience intermittent shoulder pain and had not recovered from these events.				Y					N	12/19/2002	01/21/2003	33	MRI-tenonitis (3/25/03). EMG (no results provided) 4/2003	UNK	UNK					200301756	1						1	Hypokinesia; Pain; Tendonitis	FLU3~SANOFI PASTEUR~U0945AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215416	01/22/2004	ND	63.0	63		F	07/19/2002	From telephone call received on 7/17/02 it was reported that a 63 year old female pt received a Fluzone vaccine administered on 11/7/01. The pt stated that she had drop foot syndrome, which occurred approximately one week after receipt of vaccine. Her physician feels this might be attributed to Fluzone. The pt told the reporter of this event that her treating physician instructed the pt to obtain as much info as she could about the vaccine. Product insert, lot # and manufacturer. Pt called this pharmacist because this is the facility where she received flu vaccination during one of the public clinics. The reporter is a pharmacist at the facility that holds public flu clinics (grocery store). She did not have any other additional info at this time.									U	11/07/2001	11/14/2001	7		UNK	UNK					U200200540	1						1	Peroneal nerve palsy	FLU3~SANOFI PASTEUR~U0691AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215418	01/22/2004					F	11/05/2003	Five patients experienced local reactions, one pt went to ER due to large local reaction size of an orange, knot, Keflex prescribed, MD dx cellulitis, red, warm, tender to touch. Info on other 4 patients be need to be obtained. At this time, the pt that went to ER is identified as an adult female. Additional info to be provided at later time.				Y					U					UNK	UNK					U200200823	1						1	Cellulitis; Injection site erythema; Injection site mass; Injection site pain; Injection site reaction; Injection site warmth	FLU3~SANOFI PASTEUR~U0881AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215419	01/22/2004					M	01/29/2003	From telephone correspondence received on 10/14/02, it was reported that an adult male was vaccinated with Fluzone (lot # U0872AB) IM on 10/9/02. The following day, on 10/10/02, the patient experienced a red and itchy body. Benadryl was administered and helped. On 10/14/02, it was reported that the patient's hands and feet were swollen. It is not reported whether the patient recovered from these adverse events.									U	10/09/2002	10/10/2002	1		OTH	OTH					U200200824	1						1	Erythema; Oedema peripheral; Pruritus	FLU3~SANOFI PASTEUR~U0872AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215420	01/22/2004		30.0			F	01/29/2003	From telephone correspondence received on 10/14/02, it was reported that a 30 year old female received Fluzone (lot number U0904CA) on 10/10/02. The vaccination was administered IM in the right deltoid. Three hours post-vaccination, the patient complained of joint pain in the right shoulder extending to the clavicle. She was prescribed Tylenol and the event resolved by 10/11/02. On 10/12/02, the patient experienced soreness under her right arm. By 10/14/02, she was also complaining of sore lymph node in the cervical area. At the time of the report, the patient was being evaluated by a neurologist for numbness that extended from her elbow to the finger of the right upper extremity. An MRI was done and results are pending. It was not reported whether the patient recovered from these adverse events.				Y					U	10/10/2002	10/10/2002	0	MRI done: results pending	OTH	OTH	Birth control pills				U200200825	1						1	Arthralgia; Hypoaesthesia; Lymph node pain; Lymphadenopathy	FLU3~SANOFI PASTEUR~U0904CA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215421	01/22/2004	LA	40.0	40		F	01/30/2003	From telephone contact received on 10/14/02, it was reported that a 40 year old female pharmacist (DOB 2/1/1962) was administered Fluzone on 10/14/02 at 10:30AM. A short time later, she reported feeling hypoglycemic and had orange juice. Additionally, she complained of lower extremity fatigue, weakness and tingling. She also felt nauseated and went home to bed. It is not reported whether the patient recovered from these adverse events.									U	10/14/2002	10/14/2002	0		OTH	OTH					U200200826	1						1	Hypoglycaemia; Muscular weakness; Nausea; Paraesthesia	FLU3~SANOFI PASTEUR~U0918AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215422	01/22/2004		28.0	27		M	03/01/2003	From telephone correspondence received on 10/14/02, it was reported that a 28 year old (DOB 10/15/74) male patient, received Fluzone (lot # U0918AA) on 10/14/02. Following the administration of the dose, he experienced nausea and vomiting, severe, extreme weakness, achiness and tingling in his lower legs. Reportedly, he went home from work. It is not reported whether the patient recovered from these adverse events.									U	10/14/2002	10/14/2002	0		OTH	OTH					U200200827	1						1	Asthenia; Nausea; Pain; Paraesthesia; Vomiting	FLU3~SANOFI PASTEUR~U0918AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215423	01/22/2004	FL	34.0			F	10/31/2002	Information has been received from a health care professional concerning a 34 year old female who was vaccinated with a dose of Fluzone IM in the left deltoid. The date of vaccination was not reported. The lot # is U0877AA and the expiration date is 6/30/03. The patient became pale and nauseous within 2 minutes post vaccination. She also experienced vomiting (small amount), and numbness in both hands. Her lung sounds were clear and blood pressure was 140/90. She was administered with oxygen through a facemask and with Benadryl 50mg IM. She recovered two hours later.									Y				Her lung sounds were clear and blood pressure was 140/90.	OTH	OTH					U200200836	1						1	Blood pressure increased; Hypoaesthesia; Nausea; Pallor; Vomiting	FLU3~SANOFI PASTEUR~U0877AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215424	01/22/2004		52.0	52		F	03/05/2003	From telephone contact received 10/17/02, it was reported that a 52 year old (DOB 01/02/1950) female was administered Fluzone (lot # U0969AA) in the right deltoid on 10/14/02. She also received a Pneumococcal vaccine (unspecified) in the left deltoid. On 10/15/02, the patient experienced a rash from, the left shoulder to the elbow. She was seen by her doctor on 10/16/02 and was given an antibiotic (unspecified) and topical hydrocortisone cream for cellulitis. Per the reporter, these adverse events are resolving.				Y					U	10/14/2002	10/15/2002	1		OTH	OTH					U200200838	1						1	Cellulitis; Rash	FLU3~SANOFI PASTEUR~U0969AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0215425	01/22/2004	WY	43.0	43		F	04/10/2003	From initial information received on 10/18/02, 7 female employees were vaccinated on 10/15/02 and 10/17/02 with Fluzone. They experienced local reactions of redness, swelling and itching 24 hours post vaccination. The facility physician prescribed Tylenol. From additional information received on 11/4/02 via fax from reporter, 4 of the 7 employees have been identified. Patient 1 is a 43 year old female who received a Fluzone vaccination, lot # U0968AA, administered IM in the left arm in October 2002, exact date not specified. Sometime after receipt of vaccination, exact date not specified, the patient developed a 5cm, raised, warm erythema at the injection site on her left arm. The patient also complained of an ache in her arm, and mild systemic itching all over her body. The patient's left arm is still stiff and achy. The patient has not yet recovered from this event.									N	10/01/2002	10/01/2002	0		OTH	OTH					U200200844	1						1	Injection site erythema; Injection site swelling; Musculoskeletal stiffness; Pain; Pruritus	FLU3~SANOFI PASTEUR~U0968AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215427	01/22/2004	MI	54.0	54		F	11/07/2002	From initial information received via telephone on 10/21/02, it was reported that a 54 year old female patient had been vaccinated with Fluzone on 10/11/02. The patient developed a red area, 2cm in diameter, with tiny blisters and itching. The patient went to her doctor's office on 10/14/02. No other signs or symptoms reported. It was not reported whether the patient recovered.				Y					U	10/11/2002				OTH	OTH					U200200852	1						1	Injection site erythema; Injection site vesicles; Pruritus	FLU3~SANOFI PASTEUR~U0971AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215428	01/22/2004	LA	38.0	38		F	03/05/2003	From telephone correspondence received on 10/22/02, it was reported that a 38 year old female was vaccinated with Fluzone, lot U0982AA, on 10/8/02. She developed a rash approximately 12 hours after vaccination. She denied any respiratory problems and was not seen by a physician. It was reported that the patient fully recovered. This case is closed.									Y	10/08/2002	10/08/2002	0		PVT	OTH					U200200857	1						1	Rash	FLU3~SANOFI PASTEUR~U0982AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215430	01/22/2004	LA	28.0	28		F		From telephone correspondence received on 10/22/02, it was reported that a 28 year old female was vaccinated with Fluzone, lot # U0982AA, on 10/8/02. She developed a rash approximately 12 hours after vaccination. She denied any respiratory problems and was not seen by a physician. It was reported that the patient fully recovered.									Y	10/08/2002	10/08/2002	0		PVT	OTH					U200200871	1						1	Rash	FLU3~SANOFI PASTEUR~U0982AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215432	01/22/2004		27.0	27		F	11/05/2002	From telephone contact received on 10/28/02, it was reported that a 27 year old adult female was vaccinated with Fluzone, lot # U0913AA, on 10/21/02. Eight hours later, the patient experienced nausea, vomiting, and diarrhea. She was told to see her own physician on 10/23/02. It was not reported whether the patient recovered.									U	10/21/2002	10/21/2002	0		OTH	OTH					U200200882	1						1	Diarrhoea; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U0913AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215433	01/22/2004	VA	53.0	53		F	11/05/2002	From telephone contact received on 10/28/02, it was reported that a 53 year old adult female was vaccinated with Fluzone, lot # U0913AA, on 10/21/02. By 10/24/02, she complained of being tired with a low grade fever of 37.4C, sore throat, and sinus congestion. On 10/26/02, she developed a peppery roseolla-like rash that did not itch as she does with fever. Patient called to report, but was not seen. It was not reported whether the patient recovered.									U	10/21/2002	10/24/2002	3		OTH	OTH					U200200883	1						1	Fatigue; Nasal congestion; Pharyngolaryngeal pain; Pyrexia; Rash; Roseola	FLU3~SANOFI PASTEUR~U0913AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215434	01/22/2004	WA	78.0	78		M	01/30/2003	From telephone contact received on 10/28/02, it was reported that a 78 year old male patient vaccinated with Fluzone on 10/17/02 in the left deltoid. Two days later, the patient developed a hard nodule the size of a quarter. No loss of arm use, pain, or itching occurred. The nodule is still persisting at this time. The patient was advised by his pharmacist, who administered the Fluzone, to see his physician.									U	10/17/2002	10/19/2002	2		OTH	OTH					U200200884	1						1	Injection site mass	FLU3~SANOFI PASTEUR~U0922AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215436	01/22/2004	NY	50.0	49		M	01/17/2003	From telephone contact received on 10/29/02, it was reported that a 50 year old male patient vaccinated with Fluzone (lot # U0933AA) on 10/22/02. On 10/25/02, the patient reported having arthritis like symptoms with achiness and a sore throat. These symptoms were resolved within 24 hours.									Y	10/22/2002	10/25/2002	3		OTH	OTH					U200200888	1						1	Arthritis; Pain; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U0933AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215437	01/22/2004	IA	81.0	81		F	03/05/2003	From faxed correspondence received on 11/1/02, it was reported that an 81 year old elderly female was vaccinated with Fluzone (lot # U0888AA) IM in the deltoid on 10/11/02. She complained of pain at injection site, severe bruising, and decreased range of motion the next day. She was seen on 10/28/02 without bruises, or abscess, but with loss of shoulder motion. Reportedly the patient recovered. This case is closed.				Y					Y	10/11/2002	10/12/2002	1		PVT	PVT	Lipitor; Atenolol; Lotrel; Tricor; ASA; Glyburide; Nitroglycerin patch; Naproxen; Levoxyl; Tylenol PM				U200200902	1						1	Contusion; Injection site pain; Joint range of motion decreased	FLU3~SANOFI PASTEUR~U0888AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215438	01/22/2004	ND	43.0	42		F	11/14/2002	From telephone correspondence received on 10/30/02, it was reported that a 43 year old female adult received Fluzone, lot # U0918AA, on 10/16/02. She later complained of a sore elbow and was seen by her doctor who diagnosed it as bursitis. On 10/30/02, her arm developed red streaks at the injection site, which her physician described as cellulitis. She received 7 Rocephin IM injections and was placed on antibiotics. It was not reported whether the patient recovered.									U	10/16/2002	10/16/2002	0		OTH	OTH					U200200903	1						1	Arthralgia; Bursitis; Cellulitis	FLU3~SANOFI PASTEUR~U0918AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215439	01/22/2004	TX	55.0			F	01/17/2003	From telephone contact received on 10/30/02, it was reported that a 55 year old female had been vaccinated with Fluzone (lot number U0913AA) in the left deltoid. The date of vaccination was not reported. 3 to 4 days after vaccination, the patient complained of her elbow being sore. The patient also developed an area of rash that was itchy on the top of her left foot. These symptoms reportedly resolved within one week without any treatments.									Y					OTH	OTH					U200200909	1						1	Arthralgia; Pruritus; Rash	FLU3~SANOFI PASTEUR~U0913AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215440	01/22/2004	ME	39.0	39		F	05/22/2003	From telephone correspondence received on 11/1/02, it was reported that an adult female received Fluzone on 10/25/02., Approximately 2 to 3 days post vaccination, she began to experience sensations of muscle twitching, which the patient described as a numbness and tingling of the upper and lower extremities. Per the physician, the patient was experiencing paresthesias and restlessness. She has a history of psychiatric episodes and was seen by the physician to get her influenza vaccine. On 10/31/02, the patient was seen by her psychiatrist, who noted marked facial dyskinesia. The patient is currently taking several psychiatric medications for bi-polar disorder. Reportedly, the symptoms are still persisting, although the patient states they are starting to improve. From additional information received on 4/3/03 from the reporting physician, it was reported that the patient was 39 year old at the time of the administration of Fluzone, lot number is U0904CA and was given IM in her deltoid. Reportedly, the patient was seen by the physician on 10/29/02 and recovered from the adverse reactions. No further information is anticipated, this case is closed.				Y					Y	10/25/2002	10/27/2002	2		PVT	PUB	Psychiatric medications		History of psychiatric episodes and is currently taking several psychiatric medications for bi-polar disorder.		U200200926	1						1	Dyskinesia; Hypoaesthesia; Muscle twitching; Paraesthesia; Restlessness	FLU3~SANOFI PASTEUR~U0904CA~UNK~ID~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215441	01/22/2004	MA	73.0	73		F	02/27/2003	It was reported that a 73 year old adult female, received dose of Fluzone (lot # U0879AA) IM in the right arm and Pneumovax 23 (lot # 0923L) IM in the left arm on 10/18/03. The patient developed weakness in her right hand with difficulty grasping. The right hand grasp was reported weaker than the left hand. Additionally, she experienced soreness in upper arm after injection was given and the soreness has increased over the last two weeks. No site swelling or redness was reported. The patient treated with Tylenol and warm compresses to the upper arm. Per the reporting nurse, the physician feels this isn't related to the dose of Fluzone received. A copy of this report was submitted by the reporter.									U	10/18/2002			NONE	OTH	PUB	Glucophage; Lipitor; Glucotrol; Norvase				U200200928	1						1	Hypokinesia; Muscular weakness; Pain	FLU3~SANOFI PASTEUR~U0879AA~3~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0923L~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0215442	01/22/2004	IA	70.0	70		F	03/05/2003	From faxed correspondence on 11/1/02, it was reported that a 70 year old elderly female received Fluzone (lot # 40888AA) IM in the deltoid on 10/10/02. She felt normal the next day except soreness at injection site. But then she experienced progressive loss of motor control of her left shoulder. Reportedly she recovered.									U	10/10/2002	10/11/2002	1		PVT	PVT	Verapamil; Synthroid; Prilosec; Mobic; Paxil; Vicodin; Dicyclomine; Triam/HCTZ; Actos; Lipitor; Vitamin; Calcium		NONE		U200200931	1						1	Hypokinesia; Injection site pain	FLU3~SANOFI PASTEUR~40888AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215444	01/22/2004	IA	79.0	79		F	01/17/2003	From telephone contact received at manufacturer on 11/04/02, it was reported that a 79 year old female pt was vaccinated with Fluzone SV 2002-2003 USP (Lot # U0882AA) in the left arm on 10/19/02.  Two days after the vaccination, on 10/21/02, the pt complained of pain in her left arm. She was seen in her MD office on 11/04/02.  Her entire arm aches from her shoulder to her fingers. Treatment prescribed with Ibuprofen 800mg three times a day for 10 days.									U	10/19/2002	10/21/2002	2	NONE	OTH	OTH	UNK	UNK	UNK		U200200936	1						1	Pain	FLU3~SANOFI PASTEUR~U0882AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215446	01/22/2004	PA	49.0	49		F	01/30/2003	From telephone contact received at manufacturer on 11/05/02, it was reported that a 49 year old female pt had been vaccinated with Fluzone on 10/24/02.  The pt's liver function tests are abnormal.  The pt started taking cholesterol-lowering medications 6 months ago.  Her liver function tests were normal until last week.  No systemic symptoms after receipt of dose.  The pt's doctor did not locate the lot number of the product while reporting this event, but will provide it when completing a VAERS form for the manufacturer.  The MD also stated that she felt most likely that this event was not due to the Fluzone vaccine, but because it occurred in such close proximity to the receipt of dose, she felt it should be reported.									U	10/24/2002				OTH	OTH	Cholesterol lowering medications (unspecified);	NONE	High cholesterol;		U200200939	1						1	Blood cholesterol increased	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215447	01/22/2004	AR	42.0	42		F	03/01/2003	From telephone correspondence received at manufacturer on 11/05/02, it was reported that a 42 year old female received Fluzone SV 2002-2003 USP (Lot # U0882AA) on 10/29/02.  The pt reported to employee health nurse on 10/31/02 that she developed sores in her mouth, which resolved in less than 24 hours after self-treatment with Listerine mouthwash. She was not evaluated by a physician when these sore erupted; therefore the cause is unknown per reporter. This case is closed.									Y	10/29/2002	10/31/2002	2	NONE	OTH	OTH	NONE	NONE	NONE		U200200941	1						1	Mouth ulceration	FLU3~SANOFI PASTEUR~U0882AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215448	01/22/2004	IN	31.0	31		F	02/27/2003	From faxed correspondence received at manufacturer on 10/07/02, it was reported that a 31 year old female received Fluzone SV 2002-2003 USP vaccine (Lot # E31882CA) in the left arm and pneumonia vaccine (manufacturer Merck, Lot # 0165M) in the left arm on 10/02/03.  She reportedly developed a swelling of the left arm, painful and warm to touch. She applied an ice pack 10 minutes on and 15 minutes off, and was advised to call physician to order antihistamines.  It was not reported whether the pt recovered.  See case # U2002-00952 with the same reporter.									U	10/02/2002	10/02/2002	0		OTH	PVT	NONE	NONE	NONE		U200200953	1						1	Injection site warmth; Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~e31882ca~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0165m~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0215449	01/22/2004	MD	7.0			M	03/01/2003	From telephone correspondence received at manufacturer on 11/06/02, it was reported that a 7 year old male child was vaccinated with Fluzone SV 2002-2003 USP (Lot # U0930FA). The pt experienced chills, temperature 99.9F, and body aches for a period of 2 days after vaccination.  He had not previously been immunized with Flu vaccine. The pt recovered.									Y				NONE	PVT	OTH	UNK	UNK	UNK		U200200954	1						1	Chills; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U0930FA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215450	01/22/2004	FL				F	11/05/2003	Pt received dose of Fluzone 11/05/02, within 2 hours reported generalized rash and hives head to toe except for their face.  No difficulty breathing and no throat/lip swelling. No other events reported for this person.  There are a total of 3 similar reports from this facility.  A second person reported hives, generalized rash that occurred 4 days after vaccination, follow up with allergist. The third pt is employee in health center.									U	11/05/2002	11/05/2002	0		UNK	UNK					U200200966	1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~U0951AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215451	01/22/2004	VT	38.0	38		M	05/30/2003	Information has been received concerning a 38 year old male who was administered Fluzone SV 2002-2003 USP (Lot # U0944aa) on 11/06/2002.  Approximately 6 hours after vaccination, the pt experienced difficulty in verbalizing thoughts, which lasted for 2 to 3 hours.  He was fully recovered.  It was also reported that he had received influenza vaccine in the past with no problems.  From additional information received on 04/10/03, from a nurse, it was reported that the pt, vaccine administrator and physician's information be updated.  No further information is anticipated, this case is closed.									Y	11/06/2002			NONE	OTH	OTH	NONE	NONE	It was also reported that he had received influenza vaccine in the past with no problems.		U200200977	1						1	Thought blocking	FLU3~SANOFI PASTEUR~U0944AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215452	01/22/2004	NY	59.0	59		F	11/14/2002	From telephone correspondence received at manufacturer on 11/08/02, it was reported that a 59 year old adult female was vaccinated with Fluzone SV 2002-2003 USP (Lot # U0928AA) on 11/06/2002.  The next day she developed generalized itchy rash with red blotches.  Pt's condition remained unresolved at the time of report.									N	11/06/2002	11/07/2002	1		OTH	OTH	NONE	NONE	NONE		U200200979	1						1	Erythema; Rash macular; Rash pruritic	FLU3~SANOFI PASTEUR~U0928AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215453	01/22/2004	LA				F	03/01/2003	From telephone correspondence received at manufacturer on 11/06/02, it was reported that an adult female pt received Fluzone SV 2002-2003 USP (Lot # U0932AA) on 11/01/2002.  The next day, she developed numbness and tingling in her left arm.  At the time of the report, her condition remained unresolved.  See case # U2002-00958 with same reporter.									N	11/01/2002	11/02/2002	1		OTH	OTH	NONE	NONE	NONE		U200200980	1						1	Hypoaesthesia; Paraesthesia	FLU3~SANOFI PASTEUR~U0932AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215454	01/22/2004	MI	1.3	1	.3	M	01/17/2003	From telephone contact received at manufacturer on 11/12/02, it was reported that a 15 month old male had been vaccinated with Fluzone SV 2002-2003 USP on 11/01/02 in the right deltoid.  The mother of the pt reported a 4x3 inch area of bruising and warmth at the site.  Initially, there had been only redness prior to bruising.  No other symptoms were noted.  The pt has no bleeding disorders.  The reporting physician received this information via a telephone call from the pt's mother; the child did not have an office visit for this event.									U	11/01/2002			NONE	OTH	OTH	NONE	NONE	NONE		U200200998	1						1	Contusion; Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U0982AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215455	01/22/2004	MD	60.0	60		F	12/03/2002	From telephone correspondence received at manufacturer on 11/13/02, it was reported that a 60 year old adult female received Fluzone SV 2002-2003 USP (Lot # U0930FA) on 11/06/02.  The following morning the pt broke out in hives and a generalized rash, and experienced swollen lips and itchy eyes.  There was no reported difficulty with breathing. She was administered Allegra 10mg and Benadryl.  Pt had received Fluzone for the past 5 years with no history of allergic reactions or egg allergies.  It was not reported whether the pt recovered.									U	11/06/2002	11/07/2002	1		OTH	OTH	NONE	NONE	Pt had received Fluzone for the past 5 years and had no history of allergic reactions.  No egg allergies.		U200201003	1						1	Eye irritation; Eye oedema; Face oedema; Urticaria	FLU3~SANOFI PASTEUR~U0930FA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215456	01/22/2004	FL	66.0	66		F	06/03/2003	It was reported that a 66 year old female received Fluzone SV 2002-2003 USP (Lot # U0953AA), administered on 11/08/02.  Within 24 hours of dose received, on 11/09/02, the pt experienced a transient ischemic attack and weakness in left leg while driving.  No accident was involved.  The episode resolved quickly. The pt was seen in the ER and the event was diagnosed as a possible transient ischemic attack.  She was released from the ER the same day.  From additional information received on 04/10/03 from a health care facility it was reported that the pt received Fluzone SV 2002-2003 USP (Lot # U0953AA) IM in the right deltoid on 11/08/02 sometime between 8:00 and 9:00 AM.  On 11/09/02 at 12:12PM, the pt experienced a transient ischemic attack and weakness in left leg while driving.  An echocardiogram showed trace MR and Holter monitoring revealed rare SVT.  An ultrasound of the carotids and CT of the head were normal.  The pt did not have any illness at the time of vaccination.  Pre-existing medical conditions included increased lipids, hypertension, psoriasis , TMJ and spinal stenosis. Concomitant medications included calcium, carisoprodol, diclofenac, dovonex, lipitor, nexium and psorcon.  No other medically significant information was provided.  No further information is anticipated, this case is considered closed.				Y					Y	11/08/2002	11/09/2002	1	ECHO: trace MR; HOLTER: rare SVT; Carotid ultrasound: wnl; CT of head: wnl;	OTH	OTH	Calcium; Carisoprodol; Diclofenac; Dovonex; Lipitor; Nexium; Psorcon;	NONE	History of increased lipids, hypertension, psoriasis, TMJ and spinal stenosis;		U200201005	1						1	Asthenia; Laboratory test abnormal; Transient ischaemic attack	FLU3~SANOFI PASTEUR~U0953AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215457	01/22/2004	MA	47.0	47		M	01/17/2003	From telephone contact received at manufacturer on 11/14/02, it was reported that a 47 year old male was vaccinated with Fluzone SV 2002-2003 USP (Lot # U0927AA) on 11/13/02.  Immediately after the vaccination, the pt felt chest tightness and lung congestion.  He felt no further respiratory distress after the use of inhaler, but felt disoriented and anxious.  After 1 hour, he drove home where he experienced muscle aches, joint stiffness and extremity tingling.  He also reported a restless night sleep, with vivid dreams.  He felt fine in the morning.  He drove to work, but felt dizzy so he returned home.  He will see his physician today at 14:00 11/14/02.				Y					U	11/13/2002	11/13/2002	0		OTH	OTH	NONE	NONE	NONE		U200201007	1						1	Abnormal dreams; Anxiety; Chest discomfort; Disorientation; Dizziness; Insomnia; Joint stiffness; Nasal congestion; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U0927AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215458	01/22/2004		57.0	57		F	03/01/2003	It was reported that a 57 year old female patient was vaccinated with Fluzone on 11/4/02. The patient reported to the nurse that she developed chest pain and chest tightness on 11/5/02. The symptoms resolved without physician evaluation.									Y	11/04/2002	11/05/2002	1		OTH	OTH			Cigarette smoker		U200201008	1						1	Chest discomfort; Chest pain	FLU3~SANOFI PASTEUR~U0905FA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215459	01/22/2004		40.0			F	11/21/2002	From information received on 11/14/02, it was reported that a 40 year old female was vaccinated with FLUZONE on 11/6/02 and reported to the nurse that she developed chest pain and chest tightness. The patient was not evaluated by a physician. The patient reported persistence of symptoms and was advised to seek medical attention. It was not reported whether the patient recovered.									U	11/06/2002				OTH	OTH					U200201009	1						1	Chest discomfort; Chest pain	FLU3~SANOFI PASTEUR~U0905FA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215460	01/22/2004	MN	8.0	8		F	05/30/2003	From faxed correspondence on 11/12/02, it was reported that an 8 year old female child received FLUZONE, lot # U0886AA, on 10/21/02. That same day, the patient developed a possible vesicular rash on top of ear. The patient recovered. No further information was provided from correspondence received on 4/14/03. This case is closed.									Y	10/21/2002	10/21/2002	0		PVT	PVT	Flovent; Albuterol	NONE	Asthma		U200201011	1						1	Rash vesicular	FLU3~SANOFI PASTEUR~U0886AA~4~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215462	01/22/2004		48.0	48		F	03/01/2003	From telephone contact on 11/19/02, it was reported that a 48 year old female received Fluzone (lot number U0929AA) at a pharmacy on 10/22/02. The patient had immediate pain at injection site along with a large bruise. The patient was seen by her primary care doctor on 11/15/02 and was diagnosed with Tendonitis and bursitis.				Y					U	10/22/2002	10/22/2002	0		OTH	OTH					U200201037	1						1	Bursitis; Contusion; Injection site pain; Tendonitis	FLU3~SANOFI PASTEUR~U0929AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215463	01/22/2004		46.0	46		F	03/01/2003	From information received on 11/19/02, it was reported by a nurse that a 46 year old female employee was vaccinated with a 0.5ml dosage of Fluzone, lot # U0929AA, given IM, on 11/19/2002. Recipient reported that on the same day she experienced dizziness, fatigue, nausea, and soreness at injection site with pain down to her forearm, injection site was also warm to touch. Patient was not evaluated by a physician.									U	11/19/2002	11/19/2002	0		OTH	OTH					U200201039	1						1	Dizziness; Fatigue; Injection site pain; Injection site warmth; Nausea	FLU3~SANOFI PASTEUR~U0929AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215464	01/22/2004		48.0	48		F	03/01/2003	From telephone contact received on 11/20/02, it was reported by a nurse that a 48 year old female received Fluzone (lot number U0966AA) administered IM in the left deltoid on 11/14/02 at 1:45 pm. The patient reported that on 11/19/02, she started having numbness in her thighs. The patient has not seen a doctor. The symptom has not yet resolved.									N	11/14/2002	11/19/2002	5		OTH	OTH					U200201044	1						1	Hypoaesthesia	FLU3~SANOFI PASTEUR~U0966AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215465	01/22/2004	OR	45.0	45		F	08/19/2003	From telephone contact received on 20/Nov/2002, it was reported that a 45-year-old female had been vaccinated with FLUZONE SV'2002-'2003 USP (lot number U0953AA) on 19/Nov/2002. The patient developed a migraine headache within 2 hours of the vaccination. It is not reported whether the patient recovered.									Y	11/19/2002	11/19/2002	0		OTH	OTH					U200201046	1						1	Migraine	FLU3~SANOFI PASTEUR~U0953AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215471	01/22/2004	NY	5.0	25		F	03/05/2003	It was reported by a physician that a 5 year old female developed a hand-sized area of erythema with white papules at vaccination site several days after vaccination. Pt was vaccinated with Fluzone (U0941AA), date not reported. This was reported by child's mother, pt was not seen by a physician, recovery status is unknown. From additional correspondence received on 1/23/03, it was reported that the date of vaccination was 11/25/02. The pt did not have any pre-existing diagnosis or illnesses at time of vaccination. No other vaccinations were given within 4 weeks of the original vaccination date. The pt reportedly recovered from the events. This case is closed.									Y	11/25/2002				OTH	OTH		NONE	NONE		U200201078	1						1	Injection site erythema; Injection site rash; Rash papular	FLU3~SANOFI PASTEUR~U0941AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215472	01/22/2004	CT	32.0	32		F	03/05/2003	It was reported that a 32 year old female pt was vaccinated with a 0.5ml of Fluzone (U0930FA) IM in the deltoid on 10/29/02. The pt developed a fluid filled blister that drained spontaneously 2 days later. The pt was seen at a walk in clinic and was given an antibiotic cream. A couple of days later, she went to see her private physician, who diagnosed the reaction as cell death. She was prescribed an oral antibiotic and compresses. According to the physician at the health clinic on 11/4/02, the pt developed mild induration, inflammation, ecchymosis and epidermis sloughing. A scab and an area of indentation are still present. The pt was also seen by a dermatologist.				Y					N	10/29/2002	10/31/2002	2		OTH	OTH					U200201097	1						1	Blister; Ecchymosis; Injection site inflammation; Skin exfoliation; Skin necrosis	FLU3~SANOFI PASTEUR~U0930FA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215473	01/22/2004		59.0			M	03/05/2003	It was reported that a 59 year old male pt received Fluzone (U0922AA) on 11/13/02. Route/site of administration was not reported. The pt developed a sore arm the first 24 hrs and reportedly subsided. On 11/16/02, a bilateral axillary rash began to develop, itchy and red, extended from the center of the armpit 6 inches down to the center of the body 6 inches upwards towards the biceps. The pt denied of any new product use. Pt has no allergies to eggs and thimerosal, but has history of hypertension.									U	11/13/2002	11/16/2002	3		OTH	OTH			Hypertension.		U200201109	1						1	Erythema; Pruritus; Rash; Tenderness	FLU3~SANOFI PASTEUR~U0922AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215474	01/22/2004		62.0			F	03/05/2003	It was reported that a 62 year old female received Fluzone (U0933AA) in the right deltoid on 12/7/02. The pt developed a hard and hot to the touch area at the site later that day. Within 24 hrs after vaccination, the pt experienced nausea and headache the lasted for a day.									U	12/07/2002				OTH	OTH					U200201118	1						1	Headache; Injection site induration; Injection site warmth; Nausea	FLU3~SANOFI PASTEUR~U0933AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215475	01/22/2004	ID	37.0	37		F	03/05/2003	It was reported that a 37 year old female received Fluzone (U0872AB), IM in the right deltoid on 10/25/02. Approximately one week later, the pt developed a nodule at the injection site, no pain or redness present. The nodule subsided gradually over the next two weeks. No other symptoms reported. All the symptoms resolved. This case is closed.									Y	10/25/2002	11/01/2002	7		OTH	OTH					U200201130	1						1	Injection site mass	FLU3~SANOFI PASTEUR~U0872AB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215476	01/22/2004	IL	67.0	67		M	02/20/2003	He was previously given antibiotics. It was reported that he did not recover from the event.				Y					N	10/12/2001			Chest x-ray was normal.	PVT	UNK	Lipitor	NONE	Hyperlipidemia		U200201139	1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U0672AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215477	01/22/2004	WI	70.0	70		M	01/15/2003	It was reported that a 70 year old male pt received a Fluzone vaccination on 11/25/02. About 10 days later, the pt developed pain in his hip, which was described as being like sciatic nerve pain. At the time of this report, the symptoms are unresolved. Further info is expected.									N	11/25/2002	12/05/2002	10		OTH	OTH					U200201142	1						1	Neuralgia; Pelvic pain	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215478	01/22/2004	IL	70.0	69		F	02/27/2003	It was reported that a 70 year old female pt was vaccinated with first dose of Fluzone (U0672AA), IM in the left deltoid at 2 pm on 10/21/01. In January of 2002, the pt stated that it caused coughing, specific date and time not reported. Chest x-ray was performed and the result was normal. The pt was treated with antibiotics, Nexium and was sent to a Pulmonologist who treated her for reactive airway disease. The pt reported has not recovered from the event. Linked to case: U2002-01139.				Y					N	10/12/2001			Chest x-ray normal	PVT	OTH	Synthroid, Zestril, Glucotrol	NONE	Allergies to horse serum and glucophage. History of hypertension, diabetes, hyperthyroidism.		U200201147	1						1	Asthma; Cough	FLU3~SANOFI PASTEUR~U0672AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215479	01/22/2004	NC	20.0	20		F	03/01/2003	It was reported that a 20 year old female pt received Fluzone and Menomune at approximately 3:30pm on 11/5/02. The pt reportedly felt well prior to receiving vaccinations. At 8:30pm on 11/5/02, the pt experienced onset of slight headaches and slight stiff neck with muscular aching but without joint pain. The pt felt nauseated without vomiting, no nuchal rigidity but complained of slight pain with head flexion. The pt also experienced slight tenderness at upper arm. The reporter spike with pt by phone on 11/11/02 and she was asymptomatic by 11/9/02. Th pt was not on any other medications at time of vaccination and had no previous history of any medical conditions or allergies.									Y	11/05/2002	11/05/2002	0	UA, Strep screen, CBC, CmP-all done on 11/8/02 and results were within normal limit.	OTH	OTH		NONE	NONE		U200201150	1						1	Headache; Musculoskeletal stiffness; Myalgia; Nausea; Pain; Tenderness	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~SANOFI PASTEUR~~UNK~~~MENINGOCOCCAL (MENOMUNE)~1	USA		Influenza
0215482	01/22/2004	MI	56.0	56		F	03/05/2003	It was reported that a 56 year old female pt received Fluzone (U0962BA) administered in her left arm IM at 9:50 am on 11/13/2002. Five minutes after administration the pt developed localized erythema, an area the size of a 50 cent piece on the left deltoid above bendaid, not at injection site specifically. Vitals were taken, upon request from pt, Benadryl 25mg per oral was given. Pt was monitored for 30 minutes-no swelling, no SOB, no pain or numbness was noted, pt returned to work. Pt was instructed to use cool compresses and Tylenol, pt instructed to call infection control nurse as occasion requires. Reportedly the pt recovered from this experience. This case is closed.									Y	11/13/2002	11/13/2002	0		OTH	PVT	Prevacid, Prozac	NONE			U200201166	1						1	Erythema	FLU3~SANOFI PASTEUR~U0962BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215483	01/22/2004	MI	61.0	61		F	03/05/2003	It was reported that a 61 year old female pt received 0.5cc of Fluzone (U0926BA) administered in her left arm IM at 9:10 am on 11/13/02. Fifteen minutes later the pt complained of numbness and tingling of lips and she stated her tongue felt thick. Her vital signs were stable. Benadryl 25mg was given per oral and she was monitored for 30-40 minutes. Pt stated she was feeling better and denies any SOB or wheezing. The pt was given a Benadryl 25mg tablet to take with her in case of reocurrence and instructed to call back. The pt reportedly recovered from this experience and returned to work. This case is closed.									Y	11/13/2002	11/13/2002	0		OTH	PVT	Plavix, Atenolol, Estrogen, Prevacid	NONE	Migraines, HRT, GER, TIA		U200201167	1						1	Hypoaesthesia; Paraesthesia; Tongue disorder	FLU3~SANOFI PASTEUR~U0926BA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215484	01/22/2004	SC	18.0	18		F	03/05/2003	It was reported that an 18 year old female pt received a Fluzone (U0926BA) administered in her right deltoid, at 6:25 pm on 11/12/02. Immediately after vaccination the pt stated she felt flushed and dizzy. She was given orange juice and cookies, ammonia inhalent was offered. No rash at injection site was noted, no SOB, and lungs sound clear bilaterally. Reportedly the pt recovered. This case is closed.									Y	11/12/2002	11/12/2002	0		OTH	OTH					U200201172	1						1	Dizziness; Flushing	FLU3~SANOFI PASTEUR~U0926BA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215486	01/22/2004	OH	42.0	42		F	03/01/2003	It was reported that Fluzone vaccination was administered to 2 persons who had local reactions at injection site. No specifics were provided. No pt info was provided therefore this case is not meeting the reporting criteria at the present time. Additional info received on 9/26/02: It was reported that the pt was vaccinated with Fluzone in the left deltoid on 10/24/01. Within 1-2 days post vaccination, the pt's whole upper arm became reddened and inflammed, swollen, tender and firm to the touch. The events subsided after one week. This case is closed.									Y	11/01/2001	11/02/2001	1	NONE	OTH	PVT		NONE	NONE		U200300052	1						1	Injection site erythema; Injection site induration; Injection site inflammation; Injection site oedema; Injection site pain; Injection site reaction	FLU3~SANOFI PASTEUR~U0593AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215487	01/22/2004	CA	59.0	59		F	02/27/2003	It was reported that a 59 year old female pt received first dose of Fluzone given IM in the left deltoid on 1/22/03. On 1/27/03, the pt experienced headache, malaise, congestion (nasal, chest), rhinorrhea, chills and fatigue that continued to the doctor's visit on 1/30/03 and was given a vitamin B12 shot, Tamoflu and Humabid treatment. The pt was not taking any medication and had no illnesses at the time of vaccination. The pt has no pre-existing medical conditions. No lab/diagnostic test were performed. It is not known whether the pt recovered from the events.				Y					U	01/22/2003	01/27/2003	5	NONE	OTH	PVT		NONE	NONE		U200300070	1						1	Chills; Fatigue; Headache; Malaise; Nasal congestion; Rhinorrhoea	FLU3~SANOFI PASTEUR~U0951AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215494	01/22/2004	MA	10.0			M	01/19/2004	This case was considered to be medically important based on follow up info received. Follow up info received provided an additional event of throat swelling and pt status of recovered. Info regarding Flumist was received from a healthcare professional regarding a 10 year old male pt who experienced hives, blotchy rash and weird sensation in throat. At 10 years of age, the pt received a dose on 12/16/03. On 12/16/03, the pt experienced hives (urticaria), blotchy rash (rash macular) and weird sensation in his throat (pharyngolaryngeal pain) and throat swelling on 12/16/03 twenty minutes following receipt of Flumist. The pt's symptoms improved when he was administered two teaspoons of Benadryl. He did not experience difficulty in breathing. Throat swelling was considered a medically important event (OMIC).									Y	12/16/2003			UNK	PVT	PVT	UNK	UNK	Dermatitis contact		HQWYE696017DEC03	1						1	Pharyngeal oedema; Pharyngolaryngeal pain; Rash; Rash macular; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500032P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0215526	01/22/2004	OH	0.0	24		F	11/17/2003	11/15 arm began getting red and warm-area of redness was golf ball size-continued until 11/17 when only slightly red and no induration									Y	11/14/2003	11/15/2003	1		PUB	PVT		none	none			1						1	Erythema; Swelling	FLU3~EVANS VACCINES~765795~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0215527	01/22/2004	OH	60.0	59		F	10/28/2003	3-4cm area became red and stingy continuing for 3 days.Stayed red for another day.									Y	10/24/2003	10/24/2003	0		UNK	UNK		none	none			1						1	Injection site erythema; Injection site pain	FLU3~EVANS VACCINES~765795~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0215528	01/22/2004	OH	0.0	44		F	10/31/2003	Pain moving from injection site up through shoulder joint and left side of neck.  Approximately 1-2 site of reddness working way down upper arm remained sore and red for 2 days.									Y	10/29/2003	10/29/2003	0		PUB	PVT		none	none			1						1	Injection site erythema; Injection site pain	FLU3~EVANS VACCINES~765795~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0215531	01/22/2004	NY	25.0	25		F	01/22/2004	After college I entered School of Radiography.  Almost a year into the program our class was told that we had to have Vaccinations. I was given an MMR, HEPATITIS B, AND INFLUENZAE ALL IN THE SAME DAY and so was the rest of the class. I woke up with a high fever and a terrible flu, which developed into burning in both legs from the knees down. This can be best described as acid under your skin. I saw an orthopedist for a year who x-rayed and nuclear scanned every bone in my body for a year and handed out Soma like candy to the point where I was having blackouts and I was not aware.  After not knowing what to do he referred me to another orthopedist there and in all of 3 minutes of touching my legs he knew it was not bone and it was systemic and neurological.  My symptoms kept getting worse and I ended up not being able to walk for years and I was given no physical therapy, almost died with a myelogram when I went into anaphylactic shock and these were student doctors and no neurologist was on call. I was told it was an anxiety attack. I was not the only one in my class who suddenly developed neurological problems. I was told that there was a 95% chance that I would never walk again and they thought I had Multiple Sclerosis.  Misdiagnosis #1.  I went for a second opinion and saw the Chief Resident Neurologist who explained that he thought this was caused by the vaccinations and wrote it in my chart. He asked not to be involved due to his position. It has been 13 years now and I have been diagnosed with A Viral Myelopathy, Fibromyalgia, and Anemia.  I have had 10 ambulatory surgeries with a Chronic Pain Anesthesiologist and take 546 medications a month to be functional. My gallbladder was removed in Jan 02, and the doctor said he had never seen someone so young take so much medication. When I searched for help being disabled by vaccinations was not a popular thing. I won Disability $403.00 a month by a trial with a judge and a doctor on their side. I completely depleted any savings that I had and at that time I had a tidy sum as I worked and went to school in the pursuit of making a life for myself.  Life had not prepared me for this or most people.  They felt there was no known diagnosis for what I had but it was exactly like Gillian Bar Syndrome, only sensory not motor problems. I recently received information about a Vaccine Adverse Effect Fund set up by Merc Pharmaceuticals precisely for this. It turned out that between 1990-2000, they started multi-packaging the serums and used a preservative called THIMEROSAL, THE SECOND MOST TOXIC ELEMENT ON EARTH. This information came to me strangely enough.  It was addressed to me but not meant for me. This opened some doors for me in terms of feeling that I wasn't crazy. In the medical field if they cannot diagnose you they chalk it up to your psychosomatic.  Opening this can of worms was very difficult for me as is writing this.  I don't know how I made it to this point. Family and friends can all act surprisingly different then what you would expect.  My family could not understand and went into instant denial.  I was left alone in my bedroom for over a year and my friend would periodically drop off toilet paper, towels and some food. I had to crawl to the bathroom to brush my teeth and my legs would feel like they were being torn apart. To shower I had to sit on the side of the tub.  I cried for years and wanted to die.  I spoke to my family about killing myself at the time. In addition, I didn't realize that when they did get around to giving me medication I was being turned into a drug-addict, the medications were completely depressing me and I was not even aware of the psychotic effect they were having.  I was completely high on Narcotics, which eased the physical pain, but I did not realize that it was numbing the emotional as well. I woke up night at midnight to banging on my door. It was my sister and some relatives. Completely clueless why they were there, I was informed that I had called at least 15 times in the middle of the night crying and saying I couldn't take the pain anymore and I was saying goodbye.  I thought they were nuts as I had no clue what they were talking about and I thought they were liars. I was so angry I hit my sister, which made me realize later that something was wrong with me. In addition, I started noticing bruises on my body that I couldn't account for.  My sister told me on the night she stayed over that I repeatedly fell out of bed and she tried lifting me back up, with difficulty. All the while I had no idea what she was talking about.  My sister called the doctors yet; bottles of 180 pills were dispensed per month to me. I recall I started having my first anxiety attacks, supposedly and suddenly I couldn't breathe no matter where I was. I was carrying a paper bag with me at all times and I stayed lying in bed waiting for the ceiling to close in on me. I remember telling my father there isn't enough air for me as he tried to get me to go outside. He told me that he was my father and he would protect me and carry me if he had to but he wouldn't let anything happen, but I couldn't bear it. I sounded crazy in retrospect. My parents were there a month every few months, as their business required them to travel. They convinced themselves I must have worked out too much and hurt myself or that I was a hypochondriac. Later, they realized that it could be serious, but they couldn't handle it. They came as emigrants and were self-made and were completely in denial and clueless on how to get me the little help that was out there. Eventually, I was calling my doctors telling them I could not come because I could not breath. They convinced my family I needed psychiatry immediately as I was developing panic attacks.  I remember the doctor said it was anxiety and a psychiatrist I went to see called her to see if I was checked for mitral valve prolapse, and she lied and said yes. Soon after she tested me and one little heart pill later all of this hell, and I mean hell disappeared.  You're never the same though; it took years for me to learn to trust myself and most of all, my body.  I used to have visions of it falling into pieces as I crawled or used a walker. I used to even feel that people I knew were whispering saying that's her, that's the sick one. Did they? I don't know, everyone reacts differently than you would expect. I don't think we are prepared for something like this and not having any answers, no lawyers to turn to made it that much harder. I recall feeling I was going to die if I didn't shut everyone and everything out. I had been in a relationship for 5 years and of course, we know that ended.  Thank god I was always very determined and strong-minded. I cried for years but managed to get a little better each year as I found new chronic pain doctors in later years. I felt that they can take my body but as long as I had my brain I would fight and fight I continue to do. I did not feel that I trusted my family to take care of me and I could not bare the thought of having someone lift me up and put me on a toilet.  It was humiliating. I had spent my life savings $40,000 on on medication and trying to find a private doctor to help. I felt there was nothing but desperation. My biggest fear, of course, was I would end up homeless like so many others I had seen. I always wondered how someone could get to that point.  Didn't they have parents? Couldn't someone have helped before it got to that point? I realize now that our society is completely clueless to these issues until it happens to them or someone they love. Somehow our government gets away with only giving you $215.00 a month to pay your rent. A roommate you cannot find. You can only reach HRA, SSI, or disability by phone; yet, phone is not an expense that is allotted for.  It is a luxury. How in the hell do you reach your doctors?   The courts are backed up for at least 2 years and disability usually turns you down at least 2-3 times, which I think is a stalling tactic to not pay out.  If you have a stroke, they are required to hold your file for a year, which means you have to live on $215. A month until they allow you to apply for SSI and disability.  Food stamps are 135. A month yet, how are you supposed to buy your food or the post office, I recall crying at both of these places for it was so painful to stand and try to wait?  DMV was the best. I had an old car, which I used to get to the doctors'. It was so difficult for me to get their pain wise, and when I explained by situation and showed my handicapped sticker, I was treated like an animal.  Supervisors told me to wait on line or come back another time. There on lunch, wait an hour etc. Tears did nothing. I would sit on the floor and wait as long as I could show them proof but to them I was a thorn on their side. Once though I recall on line for welfare were many who looked like drug addicts, physically challenged and even blind and they too waited for hours on line. This time though, as I spoke to the security guard they started protesting for them to let me inside to sit and wait and the line made a scene. I am grateful for those people, as they too probably understand the hardships that we face when challenged. I could not believe the inhumanity and cruelty of our fellow gov't agencies that are supposed to work for the people. They made my life a living hell, if it wasn't already. Some of those faces I will never forget. I rationalized that God was watching and what comes around goes around.  I don't write these things to elicit sorrow or sympathy; rather it is a WAKE UP CALL TO ALL HUMAN BEINGS.  This can and will happen to you, your loved ones or someone you know and we are completely ill prepared to deal with any of these life-altering situations. How do we let our society accept this? There are others out there who know the agony of what I am speaking of. The fear and terror of becoming homeless, because you're different. Yet, you did nothing wrong but it is as if you are being punished over and over as our society constantly reinforces they can't deal with you and we accept this. This is too big to close our eyes. I was recently at the disability hearing office to help a friend with a chemical imbalance. He was treated like dirt. The judge spoke to him like he was a common criminal and I felt a sigh of relief that it was not me going through this again.  Same process, same allocation of funds.  It is amazing that after 12 years they have not gone forward one bit.  Instead, the judges are all jaded and so are most of the authorities that are there to help us. I think a revamping of the system is necessary. If people are too jaded replace them. Those individuals that are there for help are going through their own private hells. Whether it be mental or physical, only once you have been chosen to live through this enormous challenge can you understand that the same world we live in is so completely different. Those who are disabled have become what I call THE FORGOTTEN PEOPLE. No one cares or at least the system acts as if they don't. My god, how can you survive on $215.00 a month? I repeat this because it shocks me that anyone in his or her right mind would know this yet, this is what it is. No wonder you think about committing crime. It happens out of desperation and a will to survive. I can't tell you how many times I thought to myself about dealing drugs or prostituting myself to save my existence. Yet, something deep inside me would not let me stoop to this level. I kept fighting and I thank my good friends and family who each helped to keep me from losing it all.  If this can happen to someone young and vivacious, and remember I was not the only one and have found so many others now too, what happens when we are old? Seriously, put yourself in this situation, completely unexpected out of the blue, your functioning like your supposed to whether it be school, work, career and everything is ripped away in an instant and you are on your own. Once I received this letter about Thimerosal or adverse effects from vaccines I began to dig feverishly. I felt that weights were lifted off my shoulders. I was reading stories about symptoms of burning pain, which if you have never felt, pray that you never do. We all have some with pinched nerves and all of the injuries that occur throughout our lives. This burning was mentally debilitating. For years I felt I couldn't handle anything since it took everything from me. On the occasion that I get it now, I still get scared as I can never forget feeling like I had hot irons on my legs. Imagine not being able to wear socks or pants or more than a year and no medication was given to me. Every day was hell, and the fire like sensatation made it realer. It has been 12 years now and I continue with my ups and downs and physical pain.  I still take medication and I still incur the same things with disability and SSI as well as those other organizations I mentioned. Luckily, I found a very good doctor who after 8 ambulatory epidurals and revamping my medication has made me functional.  I have decided to give in to having a life on medication despite my Gallbladder being removed from it.  Life is hard enough and the race grows every day.  I've decided that it may be better to have more quality of life and a shorter life than just being alive with no life at all. For all those doctors who don't become jaded and continue to fight the fight, I thank you as this one has restored some of my faith. I just found out that I am pregnant after years of grieving that with all of the medications that I have taken, I would not be able to have a child.  Now, of course, they cannot find a heartbeat, and I am extremely high risk from all of my medications and I will find out this week if I have to terminate the pregnancy, which has been an emotional roller coaster, so far. I am now 8 and half months and so far so good. It's a girl and she is my miracle.  I pray that all continues well and this is why I am writing also. I face similar challenges though since Medicare does not treat for pregnancies and Medicaid does to a point. I go to a private clinic where I have to wait at least 4 hours with an appointment. Shockingly, I had to stop all of my medications, which I did, thank god and I did not have pain to the point that I can't function. It has been the first time in 12 years that I forget sometimes what it is like living with pain everyday.  As the months go by though I begin to have some again and I am taking medication again but hopefully the baby is safe.  Again we are saying it is ok for people who are disabled whether it is physical or mental, that we aren't going to have families of our own. Medicare doesn't even acknowledge that if you have a condition whether it is depression, epilepsy, diabetes, etc., we don't have the right to have children or to love or be loved.  Who in the hell made up these rules?  I am concerned that my child will be subjected to poverty, lack of good medical care etc since my life was altered. I can do my best but I will never be able to do what I could have. I've lost many years and much time.  We may be hurt but we are not criminals nor are we inhuman. We live, we laugh and we love. We just have to struggle harder at it and some help would be appreciated. This has affected so many babies. At least, the courts recognize them but adults are not. I have always thought which is worse, to alter a babies life who hasn't really tasted life yet or an adult who has struggled to make life and a place for himself or herself in this difficult world. There is no right answer I realized. Each has a life and it is being altered and left to fend for itself. The people have to take responsibility for allowing our government to function as such. We pay taxes to employ the government facilities that are inhuman.  If we were in school we have not contributed enough for disability to give us a reasonable amount just to have shelter and food. Oh yeah, clothing is not in the picture at all. Thinking about all of these issues is frightening to say the least, but if we don't take responsibility for ensuring our protection, can we expect anyone else to? Now it is 2003 and I work part-time teaching medical terminology classes and medical insurance and coding classes. I cannot stress the importance that everyone should have these. So many leave our lives to the medical profession and they are human and make mistakes. I cannot tell you how many don't know how to interpret a prescription, let alone understanding a diagnosis. I have been in the hospital having surgery where call buttons don't work, nurses won't clean your bed pan and the wrong foods are given repeatedly to those allergic. I have saved my sisters life many times and others in hospitals too. Somehow through the years I've humbled and learned to help others as those that have helped me have a place in my heart forever. Sometimes even a kind word made a difference in the days ahead. Eventually, I hope to write a book for all those to learn your basic medical terms so that they can protect themselves. I've even had the wrong medications dispensed to me, which landed me in the hospital. Now I've learned to trust myself and I teach others as well, so they can protect themselves. A Congressman has launched an investigation, recently with the NYS DEPT OF HEALTH AND NYS DEPT OF INSURANCE AND SUPERINTENDANT.  I have the letters.  I usually speak to the caseworker.  I recently spoke to the Dept of Health. I spoke to a Public Advocate who said that I had to call the Director to file a claim. I spoke to someone at the Department of health who asked that her name be kept confidential. She said I should have grand fathered in. That it was disgusting because funds were set up for this and there were millions of dollars just sitting there for this. SHE SAID THE LAW WAS DIFFERENT THEN IN THAT NOW IF YOU HAVE A VACCINE, YOU ARE GIVEN A SLIP OF PAPER WITH A TELEPHONE NUMBER TO REPORT ANY REACTION AND THE DOCTOR'S BY LAW HAVE TO REPORT IT TO THE CDC AND THE DEPT. OF HEALTH. OBVIOUSLY, THIS WAS NOT DONE THEN. This is starting to happen in other countries as well. A commercial just came out, but for children. I am not the only adult as you will see and I think this may take some initial work but it will open a gateway for what is right and for so many others. Ten years of bad vaccines. I was healthy and quote normal than. It appears that there are two separate lawsuits going on; THIMEROSAL AND VACCINE ADVERSE EFFECTS. I have contacted all of the news stations repeatedly and they could care less. I have faxed them and letters to so many for help and lawyers. No one is interested because of the statute. I had some hope through the congressman but I see now that I was being Naive. So I reach out to Glamour to hopefully publish this and touch the lives of so many by making people aware.  It is unbelievable how many people I run into who tell me now of someone they know who has been affected by this. My friend is a chiropractor and he called me for information because so many of his patient's children became autistic after vaccines. Yet, he tells me it is a conspiracy because everything is kept on the hush.  Even my girlfriend, a nurse practitioner and she has a masters degree. Her 3rd son has ADD. She asked her doctor about the shots and they said definitely no. How can they know when they never checked the lot number? I have heard so many stories about doctors telling patients it is unrelated only to find that they called in and reported it to the CDC without telling the patient.  I understand why they are protecting themselves. They were taught that this is a good thing and therefore they are the ones carrying out this horrible destiny. At present, I have asked the congressman if he would write a letter  on my behalf, as I feel the response would be quicker and I am waiting for a response. Almost a year has passed and I am told that the department of health is dragging there feet with responding. I even spoke to a lawyer who said his young son was autistic due to the same vaccines and he too was at somewhat of a loss.  Thus anyone who was misdiagnosed due to lack of knowledge at that time is on his or her own with no recourse. Who has the right to dictate after how many years it should count if you are crippled, and if the time frame is not right, it doesn't count? No amount of money can ever make this up but for god's sake, help us to live. How can they forget about all of these lives that have been affected and damaged forever. Disease is random and so are accidents yet, somehow this seems worse because someone else inflicted this on us. It has been nearly a year now since these so called authorities were contacted.  I am so disappointed. I received one letter on the mild side effects and the worst reaction to Thimerosal is a rash. I have never been able to reach her again via e-mail or phone. A recording is on and I never receive a call back. Case worker really doesn't have anything to say to me as he returns my calls later and later than in the beginning.  My heart and mind try to forget about pursuing all of this as it caused me a lot of emotional pain. My daughter arrived finally, Thank God, healthy and for her I go on. I am so scared of these injections for her as well as what if something happens to either of us. I will never be able to secure a future for her as I could have before. But for me, I have been blessed with her. Something I never thought possible in my life arrived as a gift from god and somehow that helps to make this experience more acceptable to me. I feel that maybe I was lucky and this is my reward for all of the mistakes and oversights that nearly broke me mentally and killed me physically. What I have lost can never be replaced but my daughter is something I will thank God everyday of my life for giving her to me.  I hope that she is meant to do great things. If she is anything like her mommy she will be a fighter and I see signs of this now to my pleasant surprise. I brought her for her first doctors' visit and I was fearful because it is Medicaid that she has. As the doctor gave her a blood test he screwed up causing him to stick her 6-7 times.  I used to draw blood myself so I know it can be difficult based on the size of the vein etc., but I kept my calm and surprisingly at the end of the visit he gave us back the money for the blood test part. I was impressed and surprised. Here was a humble doctor, so I let it go and tended to my daughter. Her little hand all green and bruised for days after. This again reinforced that mistakes will be made along her life and I have to be her keeper. This will in time lead me to write the patient handbook I spoke about earlier. I hope that my experiences are and will be used as a learning experience for everyone.  I hope hat God blesses each individual who is disabled with a gift that will make his or her hellish experience somehow seem worth it. But I worry, about those that do or did not make it.  I worry for the elderly and when all of our time comes too. We will all become vulnerable to the system that we ignore at this time. I only hope that my story will reach many and that if it can prevent one person from being hurt then I have achieved something. Those that have lost loved ones I am sorry for but those that have not can wake up now and we can all join in to protect ourselves. We protect ourselves from war this is a silent war that goes on every day. We do not want to be forgotten anymore. I only hope there are more like me who have a voice, a pen or a friend to inform.  WE ARE BROKE. MY DISABLED SISTER LIVES WITH US AND MY FATHER OF MY CHILD WHO IS WAITING FOR DISABILITY FOR 2 YEARS. WE WERE EVICTED FROM THE LAST PLACE AND WE GRABBED THIS PLACE QUICKLY AND CAN'T AFFORD IT. I AM AFRAID FOR MY DAUGHTER AND OURSELVES ENDING UP HOMELESS. JUST WROTE THEY ARE INTERESTED AND WILL CALL. PLEASE HELP					Y			Y	N	05/17/1991	05/18/1991	1		UNK	UNK		flu like symptoms, burning under skin in legs				1						1	Anaemia; Anaphylactic shock; Anxiety; Contusion; Difficulty in walking; Fibromyalgia; Influenza like illness; Myelopathy; Pain; Pyrexia	FLU3~PFIZER\WYETH~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|HEPA~MERCK & CO. INC.~~UNK~UN~UN~HEP A (VAQTA)~1|MMR~UNKNOWN MANUFACTURER~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0215538	01/22/2004	SC	26.0	26		F	01/22/2004	4 hours after vaccine, began having severe stabbing abdominal pain and diarrhea. Next day had overwhelming fatigue and blurred vision. Blood pressure found to be 188/118 (I am a healthy fit individual whose BP runs 120's over 60's) Continued to have these severe spikes in BP for 3 weeks along with palpitations and blurred vision. Overwhelming fatigue persisted as well for about 2 weeks  Nurse follow up on 07/27/04 states: Chest pain, Headache.				Y					Y	12/15/2003	12/15/2003	0	CBC and CMP normal. All tests for increased catecholamine production negative. Renal ultrasound negative.	PVT	UNK	BCP (ortho cyclen)	No problems prior	Allergic to PCN, Bentyl, Cephalosporins	vomiting, faitgue, generalized pain~Influenza (Seasonal) (no brand name)~~21.00~In Patient		1						1	Abdominal pain; Blood pressure increased; Chest pain; Diarrhoea; Fatigue; Headache; Palpitations; Vision blurred	FLUX~UNKNOWN MANUFACTURER~unknown~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0215513	01/23/2004	OH	4.0	4		M	01/16/2004	On December 28, patient had a fever resulting in seizure. Taken to emergency room. Lab test for flu. Mom states A-B showed of flu. Transferred to hospital and kept overnight for observation. Siblings and parents also had flu at the time. The discharge summary received on 2/9/04 states decreased appetite, sore throat, otitis, and cough. The ER record received on 2/9/04 states incontinent, starting into space and biting.				Y	Y	1			Y	12/17/2003	12/28/2003	11	Lab test for flu - AB strain	PUB	PUB	NONE	NONE	PCN,  developmental delay, anxiety			1						1	Anorexia; Convulsion; Cough; Glossitis; Influenza; Otitis media; Pharyngitis; Pyrexia; Stupor; Urinary incontinence	DTAP~SANOFI PASTEUR~U0996CA~5~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1131AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W1582~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0272N~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Hospitalisation	Influenza
0215514	01/23/2004	CA	6.0	6		M	01/14/2004	Increased temperature 108 after received flu vaccine, mom gave Motrin.  Increased fluids.  Pedialyte and used cool compreses to decrease temperature.  Temperature decreased to 102.  About 1 hour after child taken to see MD that same night, mother was instructed to carry Motrin and to push fluids.  Mother was told that child has increased temperature due to flu vaccine, child continue with temperature 100-101 x2 day.  After this was fine.				Y					Y	12/08/2003	12/08/2003	0	NONE	PUB	PUB	Singulair; Albuterol inhaler	NONE	Asthma;		CA030144	1						1	Pyrexia	FLU3~SANOFI PASTEUR~U1091AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215515	01/23/2004	CA	1.0	1	.3	F	01/14/2004	Increased temperature 108 after received flu vaccine.  Mom gave Motrin, pedialyte and advised cool compresses to cool child down.  Temperature decreased to 101 after a few hours.  Child was taken to MD that same night.  MD told parent that increased temperature was due to flu vaccine. Child developed blister in mouth also.  MD instructed parents to continue with Motrin, pedialyte, cool compresses and to give prescription of Amoxicillin ever 6 hours for 7 days.  child ok now.				Y					Y	12/08/2003	12/08/2003	0	NONE	PUB	PUB	Albuterol with Nebulizer	NONE	Asthma;		CA030145	1						1	Oral mucosal blistering; Pyrexia	FLU3~SANOFI PASTEUR~U1091AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215516	01/23/2004	MA	57.0	57		F	01/20/2004	Skin only reaction, burning itch, plague/redness hives.									Y	10/06/2003	10/07/2003	1	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Erythema; Pruritus; Skin burning sensation; Urticaria	FLU3~SANOFI PASTEUR~765703~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215517	01/23/2004	CO	1.11	1	.9	M	01/16/2004	Seen in ER for redness and swelling treated for cellulitis with Keflex. Cellulitis of left thigh.				Y					Y	01/07/2004	01/09/2004	2	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Cellulitis; Injection site erythema; Injection site oedema	FLU3~EVANS VACCINES~766044~1~IM~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~MERCK & CO. INC.~0619N~1~IM~LL~HEP A (VAQTA)~1|PNC~PFIZER\WYETH~494316~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0215543	01/26/2004	MA	86.0			F	01/22/2004	Information regarding a flu shot was received from a consumer regarding his 86 year old mother who experienced stroke, slight fever and malaise. The pt received a dose on an unspecified date four years ago. The pt's medical history included a weak heart, arthritis, and high blood pressure; however, onset dates were not specified. The reporter stated that the pt previously got flu shot without any problems. The pt developed a slight fever and malaise after receiving an unknown brand of flu shot four years ago. The next afternoon, she experienced a stroke. She was hospitalized for about one month. She was then admitted to a nursing home for three months due to paralysis on her left side. She experienced trouble with her left leg while walking, which required a lot of therapy. She also experienced some memory problems and incontinence. The reporter indicated that the pt continues to have problems walking, and can't even get around with a walker. She now also has circulation problems. The reporter stated that the pt's current medications include: buffered aspirin, vitamin E, Lasix, Plavix, and an unknown blood pressure medication. No additional info was available at the date of this report.					Y				U				UNK	OTH	OTH	UNK	UNK	Arthritis; blood pressure increased; weak heart		HQWYE242412JAN04	1						1	Cardiovascular disorder; Cerebrovascular accident; Difficulty in walking; Malaise; Memory impairment; Paralysis; Pyrexia; Urinary incontinence	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Hospitalisation	Influenza
0215545	01/26/2004	AR	32.0	32		M	12/15/2003	Had tightness in chest about 30 minutes after he left the health department. EMS reported this to me. I called him later that day and he said he felt fine and did not go see a MD.									Y	12/11/2003	12/11/2003	0		PUB	UNK		NONE	NONE		AR0104	1						1	Chest discomfort	FLU3~SANOFI PASTEUR~U1128AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215546	01/26/2004	AR	7.0	7		F	12/15/2003	EMS reported patient with increased BP and flu like symptoms about 30 minutes after injection. Doctor watched her for several hours and said she was fine. I called later and her mother said she was fine.				Y					Y	12/11/2003	12/11/2003	0		PUB	UNK		NONE	NONE		AR0204	1						1	Blood pressure increased; Influenza like illness	FLU3~SANOFI PASTEUR~U1128AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215547	01/26/2004	AR	12.0	12		F	12/15/2003	EMS reported patient with increased BP, paleness and sweating about 30 minutes after injection. Doctor's office called and said she was fine. I called later and the father said she was doing fine.				Y					Y	12/11/2003	12/11/2003	0		PUB	UNK		NONE	NONE		AR0304	1						1	Blood pressure increased; Hyperhidrosis; Pallor	FLU3~SANOFI PASTEUR~U1128AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215548	01/26/2004	AR	8.0	8		M	12/15/2003	EMS reported patient with elevated BP, pale and sweating (flu-like symptoms). Doctor's office called and said that he was fine. I called later that day and the father said he was fine.				Y					Y	12/11/2003	12/11/2003	0		PUB	UNK		NONE	NONE		AR0404	1						1	Blood pressure increased; Hyperhidrosis; Influenza like illness; Pallor	FLU3~SANOFI PASTEUR~U1128AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215549	01/26/2004	AR	32.0	33		M	12/15/2003	Stated he got weak and nauseous about 30 minutes after flu injection. EMS reported this to me. I called him later that day and he said he was fine and did not go see a doctor.									Y	12/11/2003	12/11/2003	0		PUB	UNK		NONE	NONE		AR0504	1						1	Asthenia; Nausea	FLU3~SANOFI PASTEUR~U1128AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215550	01/26/2004	CA	47.0	46		F	01/16/2004	Received the injection at 11:15am 1/15/04. At approx. 1pm arm red, swollen and erythema from shoulder sore to elbow bullae at injection site. Benadryl 100mg-ce pack. Sent home.				Y					Y	01/15/2004	01/15/2004	0	NONE	PUB	PUB		NONE		Diarrhea~Influenza (Seasonal) (no brand name)~1~0.00~In Patient	CA040003	1						1	Erythema; Injection site erythema; Injection site oedema; Injection site pain	FLU3~EVANS VACCINES~766321~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0215551	01/26/2004	NE	53.0	53		M	01/24/2004	Chills, fever, malaise, headache, weakness, ongoing but improved (also profuse sweating)-aseptic meningitis and focal encephalitis. The discharge summary received on 3/23/04 states pulmonary nodule, pulmonary edema, bronchiectasis, swollen lymph nodes, anorexia, weight loss, atelectasis, nausea andn sedation. 60-day follow up on 04/21/04: Pt has recovered from adverse events.  Pt developed focal encephalitis and aseptic meningitis temporally associated with influenza vaccination.  His headaches were disabling but have resolved.  Coincedental versus cause and effect...other cases? Medical records state myalgia, arthralgia, dizziness. msv					Y	9			U	12/04/2003	12/08/2003	4	CSF WBC 230, 20% poly 72% lymph 3% mono 8 RBC protein 102; abnormal brain MRI with focal encephalitis like changes in right hypothelamus area. Pulmonary function decreased, hyponatremia, CSF abnormal, IgG antibody elevation.  Encephalitis, lung disease not medical tests.  Pt was found to have herpes simplex. msv	OTH	PVT	Lipitor	NONE	Tobacco abuse, hyperlipidemia, osteoarthritis, GERD Medical records state viral infection. msv			1						1	Anorexia; Arthralgia; Asthenia; Atelectasis; Bronchiectasis; CSF test abnormal; Chills; Dizziness; Encephalitis; Headache; Herpes simplex; Hyperhidrosis; Hyponatraemia; Lung disorder; Lymphadenopathy; Malaise; Meningitis; Meningitis aseptic; Myalgia; Nausea; Pulmonary oedema; Pyrexia; Somnolence; Weight decreased	FLU3~EVANS VACCINES~765413~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0215552	01/26/2004	AR	9.0	9		M	12/15/2003	States he got hot from head to toe; very pale and increased BP. Reported by EMS. I called the family later that day, grandmother said he was fine and did not go to doctor. This happened about 30 minutes of vaccination.									Y	12/11/2003	12/11/2003	0		PUB	UNK		NONE	NONE		AR0604	1						1	Blood pressure increased; Feeling hot; Pallor	FLU3~SANOFI PASTEUR~U1128AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215553	01/26/2004	AR	12.0	12		M	12/15/2003	EMS reported patient with elevated BP and flu like symptoms about 30 minutes after injection. I called the mother later she said she did not take him to the doctor but he was fine.									Y	12/11/2003	12/11/2003	0		PUB	UNK		NONE	NONE		AR0704	1						1	Blood pressure increased; Influenza like illness	FLU3~SANOFI PASTEUR~U1128AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215554	01/26/2004	OH	3.0	3		M	01/21/2004	Temperature of 104 16 hours after injection. Laying around; decreased PO intake. Fever lasted two days. No fever 3 and 4 days after but fever 104 on the 5th day. Brought to Pediatrician on 5th day. Dx'ed with OM.									Y	12/19/2003	12/20/2003	1	NONE	PUB	PUB		NONE	Peanuts, wheat eggs allergies; Craniosynestosis; Asthma; Eczema			1						1	Lethargy; Oral intake reduced; Otitis media; Pyrexia	FLU3~SANOFI PASTEUR~U1131AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215555	01/26/2004	PA	51.0	51		F	11/04/2003	Within 15 minutes of receipt of vaccine, developed swelling, redness, itching at immunization site. Took 50mgs Benadryl with good response. Repeated Benadryl dose the next day.									Y	10/28/2003	10/28/2003	0	NONE	PVT	PVT	Vitamin C; Vasotec; Premarin	Eosinophilic gastroenteritis	Latex; Codeine; Feldene; PPD solution; Hypertension; Asthma, Eczema			1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Pruritus	FLU3~EVANS VACCINES~765998~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0215601	01/27/2004	WA	14.0	13		M	01/20/2004	This report of a special interest event is being submitted in an expedited time frame as requested by the FDA.  Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her 14 year old son who experienced head cold and wheezing.  At 14 years of age, the pt received a dose on 12/09/03.  Seven to 9 days post-immunization, the child developed a head cold (nasopharyngitis).  The head cold resolved after 9 to 10 days without treatment.  On 01/03/04, he developed another head cold with wheezing.  The mother reported that the child's physician was contacted.  The physician prescribed an increased in the frequency of albuterol and Azmacort.  As of 01/12/04, the symptoms persisted.  No additional information was available at the time of this report.									U	12/09/2003	01/03/2004	25	UNK	PVT	PVT	Albuterol; Azmacort;	UNK	Asthma;		HQWYE268113JAN04	1						1	Nasopharyngitis; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0215624	01/27/2004	CA	60.0			F	01/13/2004	Heart attack at home, called 911, taken to hospital, couldn't revive.  County coroner called because sudden death.  Family thinks death is a result of flu shot received about 2 weeks ago.	Y	01/10/2004							N		01/10/2004		UNK	PVT	OTH	UNK	UNK	UNK			1						1	Myocardial infarction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0215625	01/27/2004	WI	18.0	18		M	01/14/2004	Dry cough, high temperature 103 F, unable to break high fever.  IV MD x2 liters given transfer to another hospital. The medical record received on 3/16/04 states headache, chills, sore throat, decreased appetite, nausea, bronchitis, volume depleted, lethargic, and bacterial pneumonia. (no site problem). Most likely did Ar: deployed overseas.				Y	Y				U	01/07/2004	01/12/2004	5	NONE at this facility	MIL	MIL	NONE	NONE	NONE			1						1	Anorexia; Bronchitis; Chills; Cough; Headache; Lethargy; Lung disorder; Nausea; Pharyngolaryngeal pain; Pneumonia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0215627	01/27/2004	GA	40.0	40		F	01/21/2004	Patient states the day after she received the flu vaccine she developed joint pain of her extremities, shoulder and neck area. She then noticed approximately 10-14 days later becoming short of breath which seemed to gradually become worse and had left sided chest pain which made her have a hard time taking a deep breath. She was seen by her PCP approximately mid November and subsequently was referred to a Cardiologist and Pulmonogist due to continued shortness of breath. Patient states multiple tests were done that were normal. Referred to a Rheumatologist 1/6/4. Labs showed ANA positve, ANA titer 1:320. Patient continues to be short of breath and presently being treated with prednisone. Patient states MD feels she will need to continue steroids for one year. Employee has been out of work since the beginning of December.				Y					N	10/14/2003	10/15/2003	1	Labs showed ANA positve, ANA titer 1:320.	PUB	PVT	Synthroid; Iron and Vitamin supplement	NONE	Hypothyroidism			1						1	Arthralgia; Chest pain; Dyspnoea; Laboratory test abnormal; Neck pain; Shoulder pain	FLU3~SANOFI PASTEUR~U1081AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215628	01/27/2004	TX	4.0	4		M	01/19/2004	5.1x3.8cm area of edema, erythema and heat around injection site 1 day after immunizations.  Given pt advised to use Benadryl and ice packs.									Y	11/12/2003	11/12/2003	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site warmth	DTAP~GLAXOSMITHKLINE BIOLOGICALS~2594A2~4~IM~LL~DTAP (INFANRIX)~1|FLU3~EVANS VACCINES~765667~1~IM~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~W1582~4~~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0274N~1~SC~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA		Influenza
0215630	01/27/2004	MI	1.0	1	.0	F	01/14/2004	Mother phoned 01/13/04 had 3 day history of rash, 20 lesions some blistered, some red, 1 scab.  Afebrile, developed rash 01/10/04.									U	12/19/2003	01/10/2004	22		PVT	PUB	NONE	NONE	History of atopic dermatitis;			1						1	Blister; Erythema; Rash; Skin ulcer	FLU3~SANOFI PASTEUR~U1090AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X0148~3~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0276N~1~SC~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|VARCEL~MERCK & CO. INC.~0976M~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0215631	01/27/2004	OH	4.0	4		F	01/16/2004	Redness and swelling of left thigh given Benadryl in office reaction a few minutes after vaccine given.									U	01/16/2004	01/16/2004	0		PVT	PVT	NONE	NONE	RAD; Branchial cleft cyst;			1						1	Injection site erythema; Injection site oedema	DTAP~SANOFI PASTEUR~U1029DA~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1088AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0753M~3~IM~LL~HIB + HEP B (COMVAX)~1|IPV~SANOFI PASTEUR~W06262~4~SC~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1038N~2~SC~LL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA		Influenza
0215632	01/27/2004	MI	33.0	33		F	01/17/2004	The very next day (10/28) I experienced severe heartburn which turned into chest pain. Soon, my arm (left) became numb. Next the left side of my face became numb and some of my left toes.				Y					U	10/27/2003	10/28/2003	1	I've had MRI, CAT scan and Endoscopy	OTH	OTH	Provera	NONE	Infertility	Stomach Problems~Influenza (Seasonal) (no brand name)~~30.00~In Patient		1						1	Chest pain; Dyspepsia; Hypoaesthesia	FLU3~SANOFI PASTEUR~U1089AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215633	01/27/2004	VA	1.0	1	.6	M	01/19/2004	Family reported patient developed a high fever (104.0 F) exactly one week following the injection of the flu vaccine.									Y	12/10/2003	12/17/2003	7	NONE	PVT	PVT	Singulair; Pulmicort; Nasonex; Albuterol, Flovent; Xopenex; Zyrtec	NONE	Reactive airway disease			1						1	Pyrexia	FLU3~SANOFI PASTEUR~U1141AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215634	01/27/2004	AZ	43.0	43		F	01/17/2004	Onset was itching on left arm in proximity to shot. Then bumps, dizziness, weakness, fast heart rate. Please note this is the 1st flu shot ever received.									Y	01/09/2004	01/09/2004	0		PVT	PVT	NONE	NONE	NONE			1						1	Asthenia; Dizziness; Heart rate increased; Injection site hypersensitivity; Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0193636	01/28/2004	FL	48.0	48		M	10/30/2003	This case was considered medically important (OMIC). Information regarding Flu Shield injection was received from a 48 year old male reporting that he experienced blurred vision and brachial neuritis following receipt of the vaccine on 10/23/02. The patient's concurrent illnesses included hepatic cirrhosis, hepatitis C, chronic obstructive airways disease and hypertension. Indication for Flu Shield was immunization. Product was administered on 10/23/02. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced soreness in his arm for the first two days following vaccination. On the third day, he experienced numbness and tingling of his left arm and hand, and blurred vision in his left eye. On 10/31/02, he was seen at a clinic and further evaluated by a neurologist who diagnosed sensory brachial plexus neuropathy (Parsonage-Turner Syndrome). The patient has partially recovered from these events and continues to have residual left upper extremity weakness.				Y					U	10/23/2002	10/26/2002	3	UNK	OTH	OTH	UNK	UNK	Chronic obstructive airways disease; Hepatic cirrhosis; Hepatitis C; Hypertension		HQWYE377121OCT03	1						2	Hypoaesthesia; Pain; Paraesthesia; Radiculitis brachial; Vision blurred	FLU3~PFIZER\WYETH~4020030~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~2	USA	Emergency room visit	Influenza
0215671	01/28/2004	LA	47.0	47		M	01/17/2004	Projectile vomiting, explosive diarrhea, extreme nausea, diaphoresis, weakness beginning approx. 6 hrs after flu shot into next day. Developed severe cough, congestion with continued weakness and fatigue. Worsening symptoms 11/23-11/26 with nausea, vomiting, diarrhea and abd. cramping. Seen by ER 11/26 with dx. gastroenteritis with N, V, D and mild dehy. 11/30/04 acute renal failure. Put on Dialysis. Developed CHF. The discharge summary received on 3/23/04 states acute tubular necrosis, interstitial nephritis and anemia.			Y	Y	Y	25	Y		U	11/17/2003	11/18/2003	1	Renal biopsy-acute tubular necrosis syst. 91/17.4 11/30/03. High BUN/Cr protein in urine. Developed CHF. ABGs=acidosis	PVT	OTH	NONE	NONE	NONE			1						1	Abdominal pain; Acidosis; Anaemia; Asthenia; Cardiac failure; Cough; Dehydration; Diarrhoea; Fatigue; Gastroenteritis; Hyperhidrosis; Nasal congestion; Nausea; Nephritis; Proteinuria; Renal failure; Renal tubular disorder; Renal tubular necrosis; Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0215674	01/28/2004	WI	20.0	20		F	01/20/2004	Small papules on stomach, bachial neck									Y	01/05/2004	01/13/2004	8	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Rash papular	ANTH~EMERGENT BIOSOLUTIONS~FAV081~UNK~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~EVANS VACCINES~765751~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~H8AB238A6~UNK~~~HEP A + HEP B (TWINRIX)~1|SMALL~PFIZER\WYETH~4020071~2~~LA~SMALLPOX (DRYVAX)~1	USA		Influenza
0215678	01/28/2004	CA	1.5	1	.5	F	01/16/2004	Fever, day 8 after vaccines. Rash, day 9 after vaccines 2 hours to MMR.  Erythema, pap, blanching rash.				Y					Y	01/06/2004	01/14/2004	8	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Erythema; Injection site discolouration; Pyrexia; Rash; Rash papular	FLU3~SANOFI PASTEUR~U1101AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~5401A2~3~~LL~HEP B (ENGERIX-B)~1|MMR~MERCK & CO. INC.~0178N~1~~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA	Emergency room visit	Influenza
0215679	01/28/2004	CA	75.0	74		M	01/21/2004	Pt received flu shot on 12/01/03.  Called clinic on 01/20/04 with complaints of arm pain upon lifting.  He felt due to flu shot.  Pt seen in clinic on 01/20/04, exam negative, was given Vioxx 25mg per mouth every AM with meals x30.  Instructed to use heat, stretching, no heavy lifting and return to clinic in 1 month.				Y					U	12/01/2003			Physical exam: negative;	PVT	PVT	ASA	NONE	NONE			1						1	Joint range of motion decreased; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0215680	01/28/2004	NC	20.0	20		F	01/20/2004	A lump formed in the shot area with a soft spot in the center.									N	12/05/2003	12/06/2003	1	NONE	MIL	MIL	BCP	NONE	NONE			1						1	Injection site mass	FLU3~SANOFI PASTEUR~U1129AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~PFIZER\WYETH~U0991AA~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0215681	01/28/2004	IA		31		F		Right eye shut side of face swelled.  No other swelling anywhere else.  No rash, no muscle weakness. Tingling on face.  4 hours post injection.									Y	12/08/2003	12/08/2003	0	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Eyelid oedema; Face oedema; Paraesthesia	FLU3~EVANS VACCINES~765971~1~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0215682	01/28/2004	MI	1.0	1	.0	F	01/22/2004	After waking from nap, had a beat red rash on trunk and face and less pronounced on arms and legs.  On left side of face on cheek had approximately 12 bumps.  No temperature but very irritable.				Y					U	01/21/2004	01/21/2004	0	Continues with rash.  ER MD diagnosed as dermatitis and prescribed Benadryl every 6 hours for 4 days.	PUB	PUB	Delsym;	Cough, runny nose, fever 01/19/04	NONE			1						1	Erythema; Irritability; Rash	FLU3~SANOFI PASTEUR~U1108AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0429N~3~~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~1237M~1~~RA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|VARCEL~MERCK & CO. INC.~0571N~1~~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0215683	01/28/2004	MN	1.0	1	.1	M	01/21/2004	Fever to 103 for 3 days. Morbilliform rash after fever; symptomatic care.				Y					Y	01/07/2004	01/14/2004	7	Rapid strep test to rule out strept throat.	PVT	PVT	NONE	NONE	NONE			1						1	Pyrexia; Rash morbilliform	FLU3~SANOFI PASTEUR~U1293AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0626N~3~IM~RL~HEP B (RECOMBIVAX HB)~1|MMR~MERCK & CO. INC.~0812N~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0215684	01/28/2004	PA	49.0	49		F	01/21/2004	Shot received approximately 11:00 AM. Symptoms: midnight: severe chills (4 blankets didn't help). Muscle aches in legs and rear end. Feeling like I was going to throw up; headache. The headache started in afternoon. I had a previous reaction approximately 7 years ago but never reported; only it happened within 1/2 hour of shot. I've had shots since then with no symptoms.									Y	01/08/2004	01/09/2004	1		PUB	PVT	Synthroid	NONE	Thyroid			1						1	Chills; Headache; Myalgia; Nausea	FLU3~SANOFI PASTEUR~U1141AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215712	01/28/2004					U		A report was received from a health care professional via the U.S. pharmacopeia Medication errors reporting program on 16 January 2004, concerning a child of unknown sex who experienced a seizure which was considered to be medically significant an unspecified length of time after receiving influenza vaccine (brand unspecified) on an unspecified date.  On a unspecified date, the vaccine experienced a seizure. It was not specified if the vaccine had recovered at the time of the report.  There was insufficient information to determine the reporter's causality assessment.  This report may be a duplicate of PJP-2004-00004 (#56258), but this could be verified within reporting timelines.  Follow-up pending  See ref: PJP-2004-00092.									U					UNK	UNK	Concomitant drugs not reported.				PJP200400102	1						1	Convulsion	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0215714	01/28/2004					F	10/10/2003	Information regarding influenza virus vaccine (manufacturer unknown) was received from a consumer regarding a female patient who experienced flu. The patient receive a dose in 2002.   Medical History: Relevant medical history was not provided.  Product Details: Indication for influenza virus vaccine was immunisation. Product was administered in 2002. Dose regimen was 1 dose (intramuscular).  Concomitant Therapy: Concomitant medications were not reported.  Event Detail: The patient developed the flu (influenza) after receiving influenza virus vaccine (manufacturer unknown). No additional information was available at the time of this report.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQWYE060207	1						1	Drug ineffective; Influenza	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0215715	01/28/2004	IL	12.0	12		M	01/07/2004	A physician reported that her 12-year-old son received an injection of FluShield (influenza virus vaccine, trivalent, types A & B (2002-2003 formula) on 11-Dec-2003.   Medical History: The reporter indicated that the patient has no relevant medical history.  Product Detail: Indication for Flu Shield (2002-2003 Formula) was immunization. Product was administered on 11-Dec-2003.  Concomitant Therapy: Concomitant medications and vaccines were not administered.  Event Details: On 11-Dec-2003, a male patient received a dose of FluShield from a lot that had expired in June 2003. On 12-Dec-2003, the patient developed an injection site reaction characterized by pain. The reporter indicated the patient's arm was treated with ice and it's better today. No additional information was available at the time of this report.									U	12/11/2003	12/12/2003	1	UNK	PVT	OTH	NONE	UNK	UNK		HQWYE622215	1						1	Injection site pain; Medication error	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0215716	01/28/2004	NJ				F	12/19/2003	A 39-year-old female reported that she received a dose of influenza virus vaccine (2002-2003 formula) (manufacturer unknown) in 2002, and experienced soreness, bruising and swelling on her left arm for 2 weeks. Medical History: The patient's concurrent illness includes hypothyroidism. Product Details: Indication for the the influenza virus vaccine (2002-2003 formula was immunisation. Product was administered in 2002. Dose regimen was 1 dose. Concomitant Therapy: Concomitant therapy included Synthroid (levothyroxine sodium). Event Details: The patient received an unknown brand of flu vaccine in 2002 in her left arm. Her arm became black and blue, and swollen for 2 weeks. Related Case(s): See related case: HQWYE376721 (adverse event, non-expedited). No additional information was available at the time of this report.									Y				UNK	OTH	OTH	Synthroid.	UNK	Concurrent Conditions: Hypothyroidism		HQWYE724704	1						1	Contusion; Pain; Swelling	FLU3~PFIZER\WYETH~~1~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0215717	01/28/2004	NJ	78.0			F	12/16/2003	Information regarding influenza virus vaccine, (manufacturer unknown) was received from a consumer, regarding her 79-year-old mother, who experienced flu-like symptoms following receipt of the influenza virus vaccine (2002-2003 Formula) when she was 78 years of age. Medical History: Relevant medical history was not provided. Product Details: Indication for Flu Shield (2002-2003 Formula) was immunisation. Product was administered on a unspecified date. Dose regimen was not provided.  Concomitant Therapy: Concomitant therapy included Lipitor (atorvastatin). Event Details: The patient experienced flu-like symptoms (influenza like illness) following receipt of the influenza vaccine 2002-2003 when she was 78 years of age. Related Case(s): See related case(s): HQWYE512824 (adverse event, non expedited). No additional information was available at the time of this report.									Y				UNK	OTH	OTH	Liptor	UNK	UNK		HQWYE743605	1						1	Influenza like illness	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0215718	01/28/2004	OK	43.0			F	12/19/2003	A 43 year old female reported that she received an IM injection of influenza virus vaccine in 2002 and experienced a red knot under her arm that would itch for several days and then resolve. The pt reports she has history of a possible allergy to preservatives. The pt previously experienced a more severe reaction of a red knot under her arm that would itch for several days and then resolve, in 2000 and 2001 after receiving influenza virus vaccine. She reported the reaction was less severe than with previous injections because the injection site was rubbed with a cotton swab after the vaccine was administered. She recovered. No additional info was available at the time of this report.									Y				UNK	PVT	PVT	UNK	UNK	Hypersensitivity		HQWYE286816OCT03	1						1	Erythema; Pruritus; Skin nodule	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0215719	01/28/2004	MI	45.0			F	12/16/2003	On a 45 year old female pt received a dose Flu Shield on an unspecified date in November 2002. On an unspecified date in November, one day post-immunization, the pt developed an injection site reaction characterized by a welt that lasted a few days. No additional info was available at the time of this report.									U				UNK	PVT	OTH	NONE	UNK	Allergies to cats, dogs and dust mites. A patch test performed by an allergist determined that the pt was allergic to thimerosal.		HQWYE379402DEC03	1						1	Injection site reaction; Injection site urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0215720	01/28/2004	NH	32.0			F	12/19/2003	A report was received from a 32 year old female consumer who developed soreness of the left arm after receiving a dose of Flu Shield on an unspecified date in December 2002. The pt developed an injection site reaction characterized by soreness of the left arm. The reporter indicated that she could not sleep for days and had trouble putting on her clothes. After a few days, the soreness resolved without treatment. No additional info was available at the time of this report.									Y					PVT	OTH	UNK	UNK	UNK		HQWYE463708DEC03	1						1	Hypokinesia; Injection site pain; Injection site reaction; Insomnia	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0215721	01/28/2004	NM	67.0			F	01/02/2004	This case was considered medically important (OMIC). Information regarding influenza virus vaccine was received from a health care professional regarding a 67 year old female patient who experienced an injection site reaction characterized by severe swelling of her arm and redness. At 67 years of age, the patient received a dose on an unspecified date in 2002. Relevant medical history was not provided. Indication for influenza virus vaccine was immunization. Product was administered on an unspecified date in 2002. Dose regimen was 1 dose. Concomitant medications were not reported. After receiving a flu vaccine on an unspecified date in 2002, the patient experienced severe swelling of her arm all the way down to her elbow (injection site swelling), and redness (injection site erythema) that lasted for several months. No additional information was available at the date of this report.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQWYE469808DEC03	1						1	Injection site erythema; Injection site reaction; Oedema peripheral	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0215722	01/28/2004	NJ	6.0			F	01/02/2004	A mother reported that her 6 year old daughter received a flu shot last year (2002), and her arm was sore for days. No additional info was available at the time of this report.									Y					PVT	PVT	Albuterol, Strattera	UNK	Asthma, attention deficit/ hyperactivity disorder, pneumonia		HQWYE633716DEC03	1						1	Tenderness	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0215723	01/28/2004					F	12/19/2003	A medical assistant reported that a female pt received influenza virus vaccine and experienced hives. The pt received a dose on an unspecified date. No additional info was available at the time of this report.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQWYE691803NOV03	1						1	Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0215724	01/28/2004	CA	40.0			F	01/02/2004	Information regarding influenza virus vaccine was received from a 41 year old female consumer who experienced severe joint pain within 24 hrs of vaccination. . At 40 years of age, the pt received a dose on an unspecified date in 2002. No additional info was available at the date of this report.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQWYE914824DEC03	1						1	Arthralgia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0215725	01/28/2004	FL	51.0			F	01/23/2004	Information regarding Flu Shield was received from a consumer, a 51 year old female pt, who experienced injection site reaction, the site was big, red, hot. At 51 years of age, the pt received a dose in 2001. The event resolved with rubbing and massage. No additional info was available at the time of this report.									Y				UNK	PVT	OTH	Synthroid	UNK	UNK		HQWYE507721JAN04	1						1	Injection site erythema; Injection site reaction; Injection site warmth	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0215726	01/28/2004	NJ	77.0			F	12/19/2003	Information regarding influenza virus vaccine was received from a consumer, regarding her 79 year old mother, who experienced flu-like symptoms following receipt of the influenza virus vaccine when she was 77 years of age. No additional info was available at the time of this report.									Y				UNK	OTH	OTH	Lipitor	UNK	Hip arthroplasty		HQWYE512824OCT03	1						1	Influenza like illness	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0215727	01/28/2004	OK	42.0			F	01/02/2004	A 43 year old female reported that she received an IM injection of a flu vaccine in 2001, at the age of 42 years, and experienced a red knot under her arm that would itch for several days and then resolve. In 2002, she experienced a similar but less severe reaction after receiving a flu vaccine. No additional info was available at the time of this report.									Y				UNK	PVT	PVT	NONE	UNK	Hypersensitivity		HQWYE837907NOV03	1						1	Erythema; Pruritus; Skin nodule	FLU3~PFIZER\WYETH~~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0215728	01/28/2004					F	12/19/2003	A medical assistant reported that a female pt received influenza virus vaccine injection and developed hives. Relevant medical history was not provided. The reporter indicated that the pt had no known allergies. Indication for influenza virus vaccine was immunization. Produce was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The pt developed hives from flu shot. No additional info was available at the time of this report.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQWYE840107NOV03	1						1	Urticaria	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0215751	01/28/2004	OH	53.0	53		F	01/28/2004	Patient claims the injection was given too high on the shoulder and in the shoulder joint or tendon.  It caused immediate pain and reduced use of her right arm which has failed to resolve.				Y					N	10/24/2003	10/24/2003	0	MRI: ?tendon tear in shoulder	PVT	PUB			history of thimerisol sensitivity			1						1	Pain	FLU3~SANOFI PASTEUR~U1269AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215735	01/29/2004	NH	1.31	1	.3	M	12/04/2003	Fever, lethargy, dehydration started 3 days after vaccine. Concern for sepsis. Given ICF bolus 2 separate ER visits. Lasted approx 10 days. Concurrent viral illness as well.					Y	1			Y	11/21/2003	11/28/2003	7	CBCD, BC, LP Medical records state abnormal lab test values. msv	PVT	UNK	NONE	NONE	NONE			1						1	Dehydration; Laboratory test abnormal; Lethargy; Pyrexia; Sepsis; Viral infection	DTAP~SMITHKLINE BEECHAM~616A2~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1170A~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0215738	01/29/2004	WI	43.0	42		F	01/28/2004	Upper arm swelling and pain.  Pain reaching to shoulder and neck.  Swelling and warm to touch with black/blue where shot given. Continued deep tissue pain off and on in shot area for 1 1/4 years.  Want pain to go away.									U	10/01/2002	10/01/2002	0	NONE	PVT	OTH	Prozac; Spironakctone;	NONE	NONE			1						1	Contusion; Feeling hot; Injection site oedema; Injection site pain; Neck pain; Shoulder pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0215781	01/29/2004	FL	4.0	4		F	01/29/2004	2 days prior to patient presentation to the pediatric clinic recevied DTaP, IPV, MMR.  Left leg injection site developed swelling, pain, and redness 24 hours prior to clinic presentation.  No fevers, difficulty breathing or swallowing.  Vital signs stable.  On presentation patient with 3 cm erythematous and edematous well circumscibed lesion on left thigh with central clearing of 1 cm around injection site.  There was no entrance site discharge.  Diagnosis:  Local Injection Site Allergic Reaction.  Treatment:  Orapred 1 mg/kg bid for 3 days and benadryl 12.5 mg/tsp every 4-6 hours for itching.  To return to clinic or ER for difficulty breathing, swallowing, fever, or doubling of injection site reaction size.				Y					Y	01/26/2004	01/27/2004	1	N/A	MIL	MIL	None	None	None			1						1	Injection site erythema; Injection site pain; Injection site swelling; Oedema; Skin ulcer	FLU3~SANOFI PASTEUR~U1172AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~PASTEUR MERIEUX CONNAUGHT~W0703~5~IM~RL~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0665N~2~IM~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0215758	01/30/2004	MO	56.0			F	12/11/2003	Patient developed hive type reaction after receiving the 2004 influenza vaccine. Seen in ER and treated with Solumedrol and Benadryl. No sequelae. Allergy updated. Dx allergic reaction possible reaction to flu vaccine.								Y	Y					UNK	UNK	Atenolol; Simethicone; Estrogens; Acetaminophen; Oxycodone; Gabapentin; Calcium carbonate; ZZaluminum Acetate Effer Top Tab		conversion disorder			1						1	Urticaria; Hypersensitivity; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1095AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Disabling	Influenza
0215760	01/30/2004	CA	69.0	69		F	11/13/2003	Headache next day adn for 4 days following shot.  Chills and fever for 3 days, congestion, sore throat and cough, now into week 2.  Taking cold tablets and cough syrup over the counter.									U	11/04/2003	11/05/2003	1	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Chills; Cough; Headache; Nasal congestion; Pharyngolaryngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0215761	01/30/2004	WI	66.0	66		M	01/28/2004	A couple of days after the shot, pt noticed pain in the left deltoid area which progressed to the upper left arm and shoulder radiating to the left fingers like his tendons were stiffening up.  He said the pain worsened to a severe level and has continued since 10/25/03.  The pain is considered tolerable after he has taken over the counter pain relieving and worsens after use of left arm.  He states during sleep and after use of left arm.  He states his range of motion of left arm is decreased.  He saw a physician for the first time 3 weeks ago who did not do any tests, but according to pt, to continue OTC meds and increase range of motion of left arm.				Y					N	10/23/2003	10/25/2003	2	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Joint range of motion decreased; Musculoskeletal stiffness; Pain	FLU3~EVANS VACCINES~765180~2~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0256N~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0215762	01/30/2004	MA	55.0	55		F	01/26/2004	About 2 months after receiving flu vaccine, pt began having pain.  Pain started in left instep, moved to right knee, then ankles, knees, hip, back and right shoulder.  Pain felt like it was moving around.  She was checked for lyme disease and gout.  Ruled out.  01/26/04, doing much better.				Y					Y	09/30/2003	12/04/2003	65	MD told her it could be from the flu shot.  CXR of right knee, blood tests.	OTH	OTH	NONE	NONE	Allergic to rubella vaccine and sulfa drugs.	Arthritis like reaction~Rubella (no brand name)~1~28.00~In Patient		1						1	Arthralgia; Back pain; Pain; Shoulder pain	FLU3~SANOFI PASTEUR~U1089AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215786	01/30/2004	MI	57.0	57		F	01/23/2004	Large local reaction taking form of a large bulls eye.									U	01/19/2004	01/20/2004	1	NONE	OTH	PVT	NONE	NONE	PCN	FLU~Influenza (Seasonal) (no brand name)~~12.00~In Patient		1						1	Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|YF~SANOFI PASTEUR~UB492AA~UNK~SC~LA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0215831	01/30/2004	OH	5.0	4		F	01/30/2004	C/O tingling bugs crawling on my leg prior to onset of left lower extremity (LLE) paralysis without continuing paresis. On exam showed hyper-reflectivity in LLE and inability to move LLE. Leg paralysis, central. Inflammatory appearing lesion in menigeal or extrameningeal tissue adjacent to leg cortex. Discharge summary states hemiplegia, pharyngitis. msv Medical records state myelitis, otitis, nervousness. msv				Y	Y	7			N	12/16/2003	01/12/2004	27	Flat plates of LLE-Neg., Blood chems-Neg., Blood and LP smears and cultures-Neg. WNV & cat scratch fever-Neg. MRI showed focal encephalitis / encephalomyelitis. Note that imaging makes it appear that most of the inflammation is outside the brain, next to the foot control area (Left leg / Right brain cortex.)	UNK	UNK	None	None	None			1						1	Hemiplegia; Hyperreflexia; Injection site inflammation; Laboratory test abnormal; Myelitis; Nervousness; Otitis media; Paraesthesia; Paralysis; Paresis; Pharyngitis; Skin ulcer	FLU3~SANOFI PASTEUR~1131AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0215834	01/30/2004	IL	19.0	19		F	01/30/2004	Patient inadvertantly received smallpox vaccination and anthrax vaccination while pregnant.  She has been enrolled in the DoD Smallpox Vaccine in Pregnancy Registry.  Her EDC is 22 Sep 04.   She will be followed closely by OB/GYN clinic with a level II ultrasound scheduled for 18-20 weeks.  No known adverse events.				Y					U	01/12/2004	01/12/2004	0	o 1/12/04 at 1026:  HCG QL:  Positive  (***Result was reported as Negative on 1/12/04 at 1035) o 1/14/04:  HCG QN:  87.6 o 1/15/04:  HCG QN:  147.9 o 1/18/04:  HCG QN:  350.4	MIL	MIL	None	None	o 2 previous pregnancies o Probable Miscarriage at 14 yo- positive urine pregnancy test followed by irregular bleeding and then heavy bleeding 3 months later.  Patient had been on Depo-Provera.  She did not seek medical evaluation. o Probable Miscarriage at 16 yo-No medical evaluation.  o Denies any recurrent skin conditions, including eczema, allergies, asthma, diabetes, cancer, immunosuppression, or heart disease.  Thinks that she may have had elevated blood pressure many years ago but was not diagnosed with hypertension.			1						1	Medication error; Unintended pregnancy	ANTH~EMERGENT BIOSOLUTIONS~Unknown~3~SC~RA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~Unknown~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~0981M~1~IM~RA~HEP A (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4030013~1~ID~LA~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0215835	01/31/2004	GA	1.35	1	.3	M	01/31/2004	Had his flu vaccine, mmr polio and varricella vaccine in Nov with 3 seizures associated with 101 on the same day as vaccines.  Had further vaccines flu, DTp, prevnar and Hib on 11.29 with a seizure without fever within 2 hours of vaccine then irritable for 36 hours.  Admited on both occasions for observation overnight. Discharge summary states anorexia. msv				Y	Y	2			Y	01/29/2004	01/29/2004	0	Medical records state EEG abnormal. msv	UNK	UNK		none	none Discharge summary states seizure Hx. msv			1						1	Anorexia; Convulsion; Electroencephalogram abnormal; Irritability; Pyrexia; Convulsion; Irritability	DTAPH~UNKNOWN MANUFACTURER~~UNK~~~DTAP + HIB (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PNC~PFIZER\WYETH~~UNK~~~PNEUMO (PREVNAR)~1|DTAP~SANOFI PASTEUR~U1007BA~4~IM~LL~DTAP (TRIPEDIA)~2|FLU3~SANOFI PASTEUR~U1232BA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~MERCK & CO. INC.~0589N~4~IM~LL~HIB (PEDVAXHIB)~2|PNC~PFIZER\WYETH~494304~4~IM~RL~PNEUMO (PREVNAR)~2	USA	Hospitalisation	Influenza
0215836	02/01/2004	RI	39.0	39		F	02/01/2004	Diarhhea 4 hours after shot Vomiting starting 12 hours after shot both continued until 24 hours after shot fatigue and aches for 72 hours  note 22 weeks pregnant									Y	01/28/2004	01/28/2004	0		PUB	PUB		None	Pregnant, 22 weeks			1						1	Diarrhoea; Fatigue; Pain	FLUX~UNKNOWN MANUFACTURER~unknown~1~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0215184	02/02/2004	MO	66.0	66		F	01/05/2004	Client reports that she received her influenza shot in left arm on 10/28/03 at doctor's office. She had previous flu shots other years. States she got sick on 10/30/03 PM with vomiting, aching, dizziness, and swelling of left arm. She says thereis an induration about 4 below shoulder where it looks like flesh is out as if from surgery.  She says the area is still hard and swollen. She says she has been back to the doctor twice for the arm and he x-rays it on 12/9/03. She saw another doctor on 12/23/03 he reported it to health department. She gave this information per telephone on 1/5/04 and came to health department on 1/6/04 to show the arm to nurses. Says it is painful to raise the arm.				Y					Y	10/28/2003	10/30/2003	2	X-ray; Blood lab work	PVT	UNK		NONE	NONE		MO200403	1						2	Dizziness; Headache; Injection site induration; Injection site oedema; Pain; Vomiting; Dizziness; Injection site induration; Joint range of motion decreased; Pain; Swelling; Vomiting	FLU3~SANOFI PASTEUR~U1103AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1103AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0215791	02/02/2004	GA	2.0	2	.2	F	12/16/2003	Flu vaccine 8:45AM, 12/15/03.  Fever 101 C 12100 Acetaminophen 3:30.  Seizure 4:15.  Lasted 7 min. Took to MD.  Gave Motrin/Acetominophen.  Temperature 102.7 and 102.9 (whole body red, like sunburn).  Temperature 100.2 took home. Gave Motrin/Acetaminophen mix at 9:30.  Temperature 102.6, infant fine at 3:30am.  No fever, redness, fine since then.  Medical Record received on 4/7/2004 states sweating.				Y					Y	12/15/2003	12/15/2003	0	Mom states MD rule out meningitis, diabetes, gar inf, CK'd potassium	PUB	PUB	NONE	NONE	NONE; Medical record received on 4/7/2004 states febrile illness.		GA03129	1						1	Convulsion; Erythema; Hyperhidrosis; Pyrexia	FLU3~SANOFI PASTEUR~4111AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0215792	02/02/2004	GA	6.0	6		M	11/26/2003	Flu vaccine administered 10/17/03.  Next day pt developed fever, nausea, vomiting.  Mom took to MD on 10/23/03.  MD did blood test and throat culture.  MD stated to mom that he thought symptoms were probably from flu shot.				Y					Y	10/17/2003	10/18/2003	1	NONE	PUB	PUB	NONE	NONE	NONE		GA03130	1						1	Laboratory test abnormal; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1145AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~5393A2~3~IM~RA~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0215793	02/02/2004	GA	86.0	85		F	11/24/2003	Client reports dizziness that started about 2 days ago.  States dizziness is severe enough that she needs to hold onto something or someone to walk.  States this happened last year after flu vaccine also.  She saw MD then and he referred her to an allergist.  MD did some testing and told her the dizziness was caused by the flu vaccine.  He told her it was because a virus from the flu vaccine had settled in her brain.  He told her this would eventually resolve which it did after 4-5 days.  She states MD did not tell her not to take the flu vaccine again.									Y	10/23/2003	11/22/2003	30	NONE	PUB	PUB	NONE	NONE	NONE	Dizziness~Influenza (Seasonal) (no brand name)~~85.00~In Patient	GA03125	1						1	Dizziness; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U1092AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215796	02/02/2004	PA	9.0	9		F	10/16/2003	Swelling, redness, moderate/severe pain at injection site (right arm affected site). Fever and chills.									Y	10/13/2003	10/14/2003	1		PVT	UNK		NONE	Asthma; Mold allergy			1						1	Chills; Erythema; Injection site pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U1269AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0541M~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0215896	02/02/2004	IN	2.0	2	.8	M	02/02/2004	Vomiting began two hours after vaccine administration and continued for 12 hours.									Y	11/03/2003	11/03/2003	0	none	PVT	PUB	none					1						1	Vomiting	FLU3~SANOFI PASTEUR~U1145AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215842	02/03/2004	CA	22.0			F		A 22 year old received her flu shot between 0600 and 0800 hrs on Friday, 1/9/04. Pt worked 4 hrs following the shot then, because she wasn't feeling well and had a fever, went home. She saw her to the doctor on Monday, 1/12/04, as she wasn't feeling well. Pt died on Wednesday, 1/21/04. The pt's husband, relayed that his wife was being treated for hypertension and diabetes. He added that when she saw her doctor on 1/12, that he was concerned about her blood pressure. The husband also said that she was coughing and had a hard time breathing when she was laying down. The ER record received on 3/8/04 states cyanosis and pale.  Chills, sweats, fatigue, unresponsive.  Nurse follow up on 06/18/04 states: Add: Acute Bronchial Pneumonia.	Y	01/21/2004							N	01/09/2004				OTH	UNK	NONE	NONE	Hypertension, diabetes, Obesity			1						1	Chills; Coma; Cough; Cyanosis; Dyspnoea; Fatigue; Hyperhidrosis; Malaise; Pallor; Pneumonia; Pyrexia	FLU3~SANOFI PASTEUR~V1134BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0215844	02/03/2004	WI	48.0	47		F	11/26/2003	One hour after administration-itching, difficulty breathing, diaphoretic, flushed. Hospital/ physicians felt recipient reacted to protein in serum. Nurse follow up on 05/26/04: Hives, chest tightness, pain in back, Weak, chest pain, Dizzy. Medical records state anaphylaxis, tachycardia. msv					Y	1			Y	11/24/2003	11/24/2003	0	UNK	OTH	PVT	UNK	NONE	Allerg; Hypokalemia; Asthma; Htn; GERD; Hyperlipidemia; Rheumatic fever;			1						1	Anaphylactic reaction; Asthenia; Back pain; Chest discomfort; Chest pain; Dizziness; Dyspnoea; Flushing; Hyperhidrosis; Pruritus; Tachycardia; Urticaria	FLU3~EVANS VACCINES~765499~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0215845	02/03/2004	CA	1.0	1	.0	M	01/26/2004	Pt was vaccinated on 1/15/04. On 1/23/04 mother noticed rash (maculo papular on trunk) that extended to face and extremities. On 1/26/04 a maculo papular rash with petechia and small purpuric lesion that blanch to pressure is evidenced during office visit, also conjunctival erythema is present. No adenopathies.									U	01/15/2004	01/23/2004	8		PVT	PVT		NONE	NONE			1						1	Erythema; Petechiae; Purpura; Rash maculo-papular; Skin ulcer	FLU3~SANOFI PASTEUR~U1139AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0132N~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1154M~1~~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0215846	02/03/2004	FL	55.0	55		F	01/26/2004	Fever, chills, painful and swelling like a golf ball but redness bigger than a baseball.									Y	01/23/2004	01/24/2004	1		MIL	MIL	Norvacs, Lopid, Zocor, Glucovance, Aspirin therapy, Bextra, Temazepam, Tylenol, darvon N, Glucosamine/Chondrotin, altace, Flexeril, fish oil	Stomach flu on 1/22/04	Sulfa, codine, doxycycline-type 2 diabetic, obesity, osteoarthritis			1						1	Chills; Erythema; Oedema; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~765747~6~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0819M~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0215847	02/03/2004	WI	51.0			F	01/30/2004										Y					PUB	PVT						1						1	Unevaluable event	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215848	02/03/2004	WI				F	11/12/2003	Reported feeling lightheaded within 5 min of receiving flu shot. BP 120/80 P 82, breathing shallow, began shaking BP 130/90 P 96. 911 called. Pt reported had dental work yesterday-didn't feel well. Pt stated had not eaten in > 12 hrs. Transported to hospital ER.				Y					Y	10/29/2003	10/29/2003	0		OTH	PVT						1						1	Anorexia; Blood pressure increased; Dizziness; Hypoventilation; Tremor	FLU3~EVANS VACCINES~765416~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0215849	02/03/2004	WI				F	11/12/2003	Within one min of receiving flu shot, pt reported burning in muscle and arm feeling stiff. BP 120/80 pt warm to touch ice pack applied to site. No redness at site. Not hot to touch. Swelling approximately 1 inch in diameter. Returned to work. No problems when called 7:30 pm.									Y	10/14/2003	10/14/2003	0		OTH	PVT		Cold sx x 1 week; no fever				1						1	Feeling hot; Musculoskeletal stiffness; Oedema	FLU3~EVANS VACCINES~765416~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0215850	02/03/2004	TX	2.0	2	.4	F	01/14/2004	Pt was given pneumovax 23 in right arm. Pt called day after to report arm is red, swollen, pain and fever of 107. Told to apply lukewarm compresses and given Tylenol for pain.									Y	01/05/2004	01/06/2004	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Erythema; Oedema peripheral; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1094AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0256N~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0215854	02/03/2004	AK	1.1	1	.1	F	01/09/2004	Rash on thighs abdomen, back and hips.  Stated looked like a raised, red birthmark.  No individual bumps.  Resolved 24 hours later.  Stated by mother of child, no fever.									Y	11/24/2003	11/25/2003	1	NONE	PUB	PUB	NONE	NONE	NONE		AK200402	1						1	Rash erythematous	FLU3~SANOFI PASTEUR~U1111AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215887	02/03/2004	AR	38.0	38		F	01/15/2004	Client reports she had 1 small cold sore along corner of upper lip starting 1/11 evening 1/12 morning time, then rec'd flu vaccine 1/12/04 around 2:40 pm. Went home after work around 3pm and noticed her cold sore was rapidly worsening and lip started to swell. 1/13 8 am exam by PHN upper lip swollen, cold sore lesion 4- along upper lip. received prescription for anti-viral per MD specified, prn with relief by 1st day of talking med.									Y	01/12/2004	01/12/2004	0		UNK	PUB	Amoxicillin-started 1/7/04 for tonsillitis	Recovering from tonsillitis	NONE		AK200404	1						1	Face oedema; Herpes simplex	FLU3~SANOFI PASTEUR~U1114AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215900	02/03/2004	KY	48.0	48		M	01/22/2004	Arm that shot was given in was sore for a few days, now arm is sore from elbow to wrist									Y	11/20/2003	11/21/2003	1	none- did not seek treatment, 1/27/04, states doing some better.	PUB	PUB					KY2004005	1						1	Pain	FLU3~SANOFI PASTEUR~M1139AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215901	02/03/2004	KY	1.4	1	.4	M	01/16/2004	Approximately 36 hours after vaccinations child had unrelieved temp of 102F, took child to ER, when temp reached 106F, was diagnosed with otitis media and treated with Motrin, Tylenol and amoxicillin.				Y					Y	12/23/2003	12/24/2003	1		PUB	PUB			cats, ragweed, molds, pollens, dust, weeds		KY2004004	1						1	Otitis media; Pyrexia	DTAP~SANOFI PASTEUR~U1007CA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1140AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0428N~4~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~494312~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0215904	02/03/2004	VA	42.0	42		F	02/03/2004	This is a 42 year-old who received her annual influenza vaccination on 01/09/04. She had been in her usual health prior to receipt of the vaccination. She states that she received the vaccination and waited approximately 10 minutes in the Immunization Department.  She returned to her workspace and in route she relates feeling flush, dizzy and having tightness in her throat. Within minutes, the symptoms seemed to be subsiding; however she suddenly experienced a worsening of symptoms. She states that she felt like she was going to pass out and had difficulty breathing. Co-workers came to assist her and stated that the client's face was lobster red.  She did not seek additional medical care, except from her fellow co-workers. She states all the symptoms seemed to subside with relaxation and deep breathing, lasting a total of about 45 minutes. Approximately 36 hours after the initial onset, the client developed cutaneous symptoms. She relates developing a large burning whelp and rash at the injection site. This subsided without intervention. Additionally, the client relates that she has developed multiple allergies in the last 6 months. She had an Allergy and Immunology work-up approximately 4 years ago. She states at that time she was only allergic to one type of pine tree. Medical record states anaphylaxis.			Y						Y	01/09/2004	01/09/2004	0	Rast Panel Pending	MIL	MIL	None contributory	none	Septra, ASA, Shellfish Medical redord states obesity, pylonephritis, herpes simplex, fibromyalgia, bone disease.			1						1	Anaphylactic reaction; Dizziness; Dyspnoea; Flushing; Injection site rash; Syncope; Throat tightness; Urticaria; Dyspnoea; Flushing; Hypersensitivity; Pruritus; Throat tightness	FLUX~UNKNOWN MANUFACTURER~U129AA~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1269AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening	Influenza
0215909	02/03/2004	MI	4.0	4		M	01/23/2004	This report of itchy rash is being submitted in an expedited time frame as requested by the FDA. Information regarding Flumist nasal solution was received from a parent regarding her 4 year old son who received a dose on 12/12/03 and developed an itchy rash. Relevant medical history was not provided. Indication for Flumist was immunization. Product was administered on 12/12/03. Dose regimen was 1 dose 1 time per day (IN). Concomitant medications were not reported. On 12/15/03, the patient, a 4 year old (medication error), developed an itchy rash from neck down to extremities (rash) described as itchy (pruritus). He was treated with Benadryl and the rash disappeared in 6 days. On 1/6/04, the same rash broke out and he was again given Benadryl. No additional information was available at the time of this report. (OMIC)									U	12/12/2003	12/15/2003	3	UNK	OTH	OTH	UNK	UNK	UNK		HQWYE247212JAN04	1						1	Medication error; Rash pruritic	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0215910	02/03/2004	VA	12.0			F	01/27/2004	This report of wheezing is being submitted in an expedited time frame as requested by the FDA. Information regarding Flumist live intranasal solution was received from a nurse regarding her 12 year old daughter who developed wheezing. At 12 years of age, the patient received a dose on 12/19/03. The patient had no relevant medical history. She had no history of asthma or wheezing. Indication for Flumist was immunization. Product was administered on 12/19/03. Dose regimen was 1 dose (IN). Patient was not taking concomitant therapy. On 12/19/03, the evening of vaccination, the patient began wheezing. She was treated with Ventolin nebulizations and an unspecified steroid inhaler. As of 1/16/03, her symptoms persisted and treatment continued. No additional information was available at the date of this report. (OMIC)									U	12/19/2003	12/19/2003	0	UNK	OTH	PVT	NONE	NONE	UNK		HQWYE440416JAN04	1						1	Wheezing; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500002P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0215911	02/03/2004	NJ	9.0	9		M	01/29/2004	This report of rash is being submitted in an expedited time frame as requested by the FDA. Follow up information received from the physician provided recovery status (patient recovered). Information regarding Flumist nasal solution was received from a physician regarding a 9 year old male patient who experienced a runny nose and a rash described as red bumps like mosquito bites. The patient received a dose on 12/12/03. The patient had no medical history. Indication for Flumist was immunization. Product was administered on 12/12/03. Dose regimen was 0.5mL (IN). Patient was not taking concomitant therapy. On 12/13/03, 1 day post immunization, the child developed a runny nose and a rash described as red bumps like mosquito bites on his back. The bumps did not itch. The rash spread from his back to his chest within a day. On 12/14/03, the runny nose resolved spontaneously. The physician reported that the child had recovered. (OMIC)									Y	12/12/2003	12/13/2003	1	UNK	PVT	PVT	NONE	NONE	UNK		HQWYE756919DEC03	1						1	Rash; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0215912	02/03/2004	MI	10.0	10		M	01/29/2004	This report of hives is being submitted in an expedited time frame as requested by the FDA. Follow up information from the pediatrician provided event outcome (patient recovered). Information regarding Flumist nasal solution was received from a pediatrician's office regarding a 10 year old male patient who developed hives all over his body. The patient received the first dose on 12/11/03. The patient had no relevant medical history. Indication for Flumist was immunization. Product was administered on 12/11/03. Dose regimen was 1 dose. Patient was not taking concomitant therapy. On 12/14/03, 3 days post immunization, the child developed hives all over his body. A nurse advised the parents to give Benadryl. The pediatrician reported that the patient recovered. (OMIC)									Y	12/11/2003	12/14/2003	3	UNK	PVT	OTH	NONE	NONE	Medical History: The patient had no relevant medical history.		HQWYE728018DEC03	1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0215914	02/04/2004	NC	79.0	79		M		The subject is a 79 year old male who was found unresponsive by his wife while enrolled in a Comparative Randomized Study of Safety and Immunogenicity of a Non-Adjuvanted RSV Vaccine Versus An RSV Vaccine Adjuvanted Wtih Aluminum Phosphate When Administered Concomitantly With A Licensed Influenza Vaccine In High-Risk Adults > or = 65 Years Of Age, Protocol Number RSV11. The subject has received RSV vaccine or Placebo and Influenza vaccine twice with the last dose on 10/27/03. Date of first dose date was not reported. The subject was found unresponsive on 1/26/04 by his wife, 91 days post immunization. As per subject's wife, it appears that the subject went out to retrieve the mail, slipped on ice and fell. She found him unresponsive. Paramedics were unsuccessful in reviving him. He was transported to the hospital where treatment was continued but unsuccessful. Subject died on 1/26/04. The event was reported by the investigator as not related to the study vaccine. Myocardial infarction.	Y	01/26/2004							N	10/27/2003	01/26/2004	91		UNK	UNK	RSV/Placebo; Zocor; Zesteril; Aspirin; Toprol; Allopurinol; Norvasec; Plavix		HTN; LVH; Heart murmur; Unsteady gait; CHF; Cardiomyopathy; Aortic stenosis; Hypercholesteremia; Venous stenosis		200400390	1						1	Coma; Fall; Myocardial infarction	FLU3~SANOFI PASTEUR~U1137HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0215922	02/04/2004	CA	56.0	55		F	11/11/2003	The night of vaccines, ran fever. 102 next day started getting red and very hot. By Friday evening 2 days after vaccines arm was swollen from shoulder to elbow and bright red hot. ER on 11/1 & 2-cellulitis bacterial family doctor 11/5/03. My arm was so swollen and red you could have fried a egg on it. I felt horrible. I thought it was the combination of both the flu and pneumonia vaccine at the same time in the same arm. It was not. Went to ER on 11/1/03-severe cellulitis bacterial. Poor administration and contamination by the LVN who administered vaccines. Had to have antibiotic injections and put on Keflex 500mg 4 x daily for 14 days and had to return to ER on 11/2/03 and my own personal physician on 11/5/03. Still not resolved. Still seeing my own physician. This is 11/11/03. My arm is still red and swollen, of course, better than it was. The medical record received on 2/17/04 states pain. Follow up 02/14/05: Arm is still red, like a rash, but  doing fine except for that. I don't think it had anything to do with the vaccinations. There was contamination during the administration of the vaccine,  I developed cellulitis. Medical record states lethergy. msv			Y	Y					N	10/29/2003	11/29/2003	31		OTH	PVT	Premarin, Pepcid, Zoloft	NONE	Hay fever; Allergic codeine; depression			1						1	Bacterial infection; Cellulitis; Erythema; Lethargy; Oedema peripheral; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0215923	02/04/2004	WI	88.0	88		M	01/26/2004	Local cellulitis and subsequently became septic requiring hospitalization. Discharge summary states fever, chills, hypotension, confusion, asthenia. msv			Y	Y	Y	8			Y	10/27/2003	11/11/2003	15	Discharge summary states bundle branch block. msv Medical record states decreased RBc's. hypokalemia. msv	PVT	PVT	Albuterol, Lipitor, Loratadine, Prevacid, NTG patch, ASA	Tremors and rhinitis	Ditropan; MSO4; B&O suppository; IPV dye Discharge summary states esophagitis, lung disease, depression, Coronary artery disease, tremor, carcinoma of prostate. msv Medical redords states hyperlipedemia. msv			1						1	Asthenia; Bundle branch block; Cellulitis; Chills; Confusional state; Hypokalaemia; Hypotension; Injection site reaction; Pyrexia; Red blood cell count decreased; Sepsis	FLU3~EVANS VACCINES~765669~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0215924	02/04/2004	IL	50.0	50		F	01/20/2004	I got flu vaccine 12/17. Bend of leg start hurting, back started hurting. Next day stomach started hurting, then but bones started hurting. Still hurting today 1/20/04. Hurts to sit, walk and stand.				Y				Y	N	12/17/2003	12/17/2003	0	Gave me arthritis; side effects from flu shot.	PUB	OTH	Albuterol; Flovent; B vitamins	NONE	Asthma			1						1	Abdominal pain upper; Arthritis; Back pain; Bone pain; Pain	FLU3~EVANS VACCINES~765852~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0215925	02/04/2004	GA	42.0	42		M		48 hours after vaccinations I developed blotchy rashes on and above head, chest, shoulders, neck and back.  Predominantly on the right side.  Rashes grew in size I was placed on Famvir and antibiotics rashes gave after 4 weeks.  Acute testicular pain also.									U	10/09/2003	10/11/2003	2		MIL	MIL	NONE	NONE	NONE	shingles: ANA flu shot same day~Anthrax (Biothrax)~4~42.00~Patient		1						1	Groin pain; Pain; Rash; Rash macular	ANTH~EMERGENT BIOSOLUTIONS~FAV071~4~UN~LA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~U1269AA~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0215926	02/04/2004	NY	35.0	35		M	01/27/2004	3 days after receiving vaccination, I developed hives all over my body.  I continue to have breakouts even now.				Y					N	10/03/2003	10/06/2003	3	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Urticaria	ANTH~EMERGENT BIOSOLUTIONS~FAV076~4~~~ANTHRAX (BIOTHRAX)~1|FLU3~EVANS VACCINES~765141~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0215927	02/04/2004	CA	3.0	3		M	12/02/2003	Influenza vaccine given IM/LA at 10:30am. Patient was instructed to wait 20 minutes in waiting room. The injection site was red and swollen when checked at 10:50am. The patient was brought back to exam room and provider notified.									U	12/02/2003	12/02/2003	0		PVT	OTH		NONE	NONE			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U1088AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0215928	02/04/2004	CA	6.5	6		M	12/12/2003	Approximately 4 hours after shots, lethargy, double vision, pale, 100 degree fever, decreased pulse. Next day, redness and swelling at injection site, right deltoid, Pneumovax.				Y					Y	12/11/2003	12/11/2003	0	NONE	PUB	PVT	Fluoride; Vitamins	NONE	NONE			1						1	Diplopia; Heart rate decreased; Injection site erythema; Injection site swelling; Lethargy; Pallor; Pyrexia	FLU3~EVANS VACCINES~766048~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1119M~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0215929	02/04/2004	NJ				U											U	12/29/2003				PUB	UNK	Medicaid	Sinusitis	Cold			1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~1119M~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0216019	02/04/2004	CA	1.3	1	.3	F	02/04/2004	PT. WAS GIVEN DTAP AND IPV IM TO LEFT LEG, FLU AND MMR TO RIGHT LEGON 02 FEB 04. SWELLING WAS NOTED TO LEFT LEG, MOTHER OF PATIENT BROUGHT PATIENT TO ER ON 03 FEB 04. PT HAD FOLLOW UP VISIT WITH PRIMARY DOCTOR ON 04 FEB 04 AND WAS DIAGNOSED WITH CELLULITIS TO LEFT LEG.				Y					U	02/02/2004	02/03/2004	1	X RAY AND LABS DONE, ORDERED BY PRIMARY CARE PROVIDER	MIL	MIL		UNKNOWN	UNKNOWN			1						1	Cellulitis; Swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~627A2~UNK~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1270AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W1233~UNK~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0274N~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0214532	02/05/2004	SC	5.0	5		M	12/23/2003	A nurse reported that a 5 year old male received his 1st dose of Flumist on 12/8/03, and approximately 4 hrs later, experienced itching, large whelps, and hives all over his body. On 12/8/03, approximately 4 hrs post-immunization, the child developed itching, large whelps, and hives all over his body. Treatment included Aveeno topical cream and Benadryl elixir by mouth. As of 12/9/03, the events persisted. No additional info was available at the time of this report.									N	12/08/2003	12/08/2003	0	UNK	OTH	PVT	Albuterol	UNK	Bronchospasm; eczema		HQWYE630015DEC03	1						2	Pruritus; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0216003	02/05/2004	DC	39.0	39		F	02/02/2004	24-48 hours after vaccine, acute onset apthor ulcers 24-48 hours later it dry whole body up in rash.									U	01/27/2004	01/28/2004	1	NONE	OTH	PUB	NONE	NONE	NONE			1						1	Rash; Skin ulcer	FLU3~SANOFI PASTEUR~U1139AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0216052	02/05/2004					M	12/16/2003	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 6-month-old male patient who experienced runny nose after being in close contact with his brother, who had received the Flumist. Medical history: Relevant medical history was noT provided. Product details: Additional suspect medication included influenza virus vaccine injection (manufacturer unknown), which he received on 06-Nov-2003. Concomitant therapy: Concomitant medications were not reported. Event details: The patient experienced runny nose (rhinorrhea) on 11-Nov-2003, after being in close contact with his brother who had been vaccinated with Flumist (accidental exposure). The infant had also received an influenza virus vaccine injection (manufacturer unknown) on 06-Nov-2003. Related case(s): The patient's brother developed the cold symptoms of a runny nose and fever following receipt of Flumist on 06-Nov-2003 (see MCN HQWYE0195). No additional information was available at the date of this report.									U		11/11/2003		UNK	OTH	OTH	UNK	UNK	UNK	~Influenza (Seasonal) (FluMist)~~0.00~In Sibling|~Influenza (Seasonal) (FluMist)~~0.00~In Sibling	HQWYE0196	1						1	Infection transmission via personal contact; Pyrexia; Rhinitis	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216053	02/05/2004	WI	43.0	43		F	10/09/2003	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a nurse practitioner regarding a 43-year-old female patient who experienced headache, nausea, tachycardia and erythema on her cheeks, forehead, and neck. At 43 years of age, the patient received her first dose on 07-Oct-2003. Medical history: The patient's concurrent illnesses include seasonal allergies and a serum-sickness like allergy to penicillin and sulfa. The reporter indicated that the patient had no history of adverse reaction to TIV flu vaccines. Product details: Indication for Flumist (2003-2004 Formula) was immunisation. Product was administered on 07-Oct-2003. Dose regimen was 0.5 mL (intranasal). Concomitant therapy: Concomitant medications were not reported. Event details: Three hours post-immunization, she experienced headache, nausea, tachycardia and erythema on her cheeks, forehead and neck. She returned to the physician's office where her vital signs were reported to be normal. She left the physician's office after lying down for a period of time. A the time she left the office, everything had resolved except the erythema. No additional information was available at the time of this report.				Y					U	10/07/2003	10/07/2003	0	UNK	PVT	PVT	UNK	UNK	Concurrent Conditions: Drug hypersensitivity, seasonal allergy.		HQWYE0843	1						1	Erythema; Headache; Nausea; Tachycardia	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0216054	02/05/2004	CA	8.0	8		M	10/16/2003	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding an 8-year-old male patient who experienced sneezing and congestion. At 8 years of age, the patient received a dose of 01-Oct-2003. Medical history: The patient has no relevant medical history. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 01-Oct-2003. Dose regimen was 0.5 mL (intranasal). Concomitant therapy: The patient was not receiving concomitant medications. Event details: the patient developed sneezing and congestion on 04-Oct-2003. As of 06-Oct-2003, the symptoms persisted. The patient's brother experienced sneezing and congestion following receipt of Flumist on 01-Oct-2003 at 11 years of age (see MCN HQWYE094909OCT03). No additional information was available at the date of this report.									N	10/01/2003	10/04/2003	3	UNK	PVT	PVT	NONE	UNK	UNK	~Influenza (Seasonal) (FluMist)~~11.00~In Sibling	HQWYE0948	1						1	Nasal congestion; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216055	02/05/2004	CA	11.0	11		M	10/24/2003	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding an 11-year-old male patient who experienced sneezing and congestion. At 11 years of age, the patient received a dose on 01-Oct-2003. Medical history: The patient's concurrent illness includes being overweight. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 01-Oct-2003. Dose regimen was 0.5 ml (intranasal). Concomitant therapy: The patient was not receiving concomitant medications. Event details: The patient developed sneezing (sneezing) and congestion (nasal congestion) on 04-Oct-2003. As of 06-Oct-2003, his symptoms persisted. The patient's brother developed sneezing and congestion following receipt of Flumist on 01-Oct-2003 at 8 years of age (See MCN HQWYE0948). No additional information was available at the date of this report.									N	10/01/2003	10/04/2003	3	UNK	PVT	PVT	NONE	UNK	Concurrent Conditions: Overweight	~Influenza (Seasonal) (FluMist)~~8.00~In Sibling	HQWYE0949	1						1	Nasal congestion; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216056	02/05/2004	NE	12.0	12		F	12/11/2003	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding her 12 year old daughter who experienced gagging, eyes watered, awful taste, headache, stomach ache and runny nose. At 12 years of age, the patient received a dose on 07-Nov-2003. Medical history: relevant medical history was not provided. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 07-Nov-2003. Dose regimen was 0.5 mL 1 time per day (nasal). Concomitant therapy: Concomitant therapy included Motrin (ibuprofen). Event details: The patient experienced gagging (retching), eyes watered (lacrimation increased) and awful taste (dysgeusia) on 07-Nov-2003. Two days later she developed headache (headache), stomach ache (abdominal pain upper) and runny nose (rhinorrhea) on 09-Nov-2003. Related Case (s): See related case(s): HQWYE944711NOV03 (adverse even, non-expedited) and HQWYE956611NOV03 (adverse event, non-expedited). No additional information was available at the time of this report.									U	11/07/2003	11/07/2003	0	UNK	OTH	PVT	Motrin	UNK	UNK		HQWYE1106	1						1	Abdominal pain upper; Dysgeusia; Headache; Lacrimation increased; Retching; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216057	02/05/2004	IN				U	10/24/2003	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a pt who experienced liquid running down the back of the throat that tasted bad and was irritating.  The pt received a dose on 10/07/03.  The reporter indicated that two pt's experienced this event; however, they are not presently identifiable.  Additional reports will be generated when identifying information is provided.  No additional information was available at the date of this report.									U	10/07/2003	10/07/2003	0	UNK	OTH	OTH	UNK	UNK	UNK		HQWYE133810OCT03	1						1	Irritability; Postnasal drip	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216058	02/05/2004	NJ	39.0	39		F	12/15/2003	A 39 year old female consumer reported that she received a dose of Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on 11/09/03.  The reporter indicated that the vaccine ran out of her nose like water.  She was instructed by the nurse to tilt her head back and the vaccine subsequently ran down her throat and she almost threw up.  No additional information was available at the time of this report.  See related case HQWYE136817NOV03.									U	11/09/2003	11/09/2003	0	UNK	PVT	OTH	NONE	UNK	UNK		HQWYE137717NOV03	1						1	Postnasal drip; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216059	02/05/2004	GA	9.0	9		F	12/15/2003	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 Formula) nasal solution (frozen)) was received from a consumer regarding a 9 year old female pt who experienced symptoms just like the flu, fever (102 deg F), sallow skin, watery eyes, loss of appetite, hacking cough and mild sore throat.  At 9 years of age, the pt received a dose on 11/04/03.  The pt experienced symptoms just like the flu (influenza like illness), fever (102 deg. F), sallow skin, watery eyes, loss of appetite, hacking cough and mild sore throat on 11/12/03. She was seen by a physician that same day.  As of 11/12/03, the pt's symptoms have not resolved.  Follow-up received from the patient's physician provided information regarding vaccines received within four weeks (none), illness at the time of vaccination (none), and duration of symptoms. She was seen by a physician the same day. The patient's mother reported that the symptoms lasted for 6 to 7 days.				Y					U	11/04/2003	11/12/2003	8	Culture throat (results: quick Strep test was negative) was done 11/12/03.  No additional information was available at the date of this report.	PVT	PVT	NONE	UNK	UNK		HQWYE140617NOV03	1						1	Anorexia; Cough; Influenza like illness; Lacrimation increased; Pallor; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0216060	02/05/2004	NJ	52.0	52		F	11/13/2003	A 52 year old female reported that she received a dose of Flumist (influenza virus vaccine, live intranasal (2003-2004 formula) on 09/15/03.  The pt's concurrent illnesses include pernicious anaemia, allergies (nonspecified) and a past history of lung cancer (diagnosed in Aug 2002, currently in remission).  The pt experienced a sore throat and sniffles for 2 days following Flumist administration on 09/15/03.  She also expressed concern regarding the administration of Flumist to people with compromised immune systems and those who are over 50 years of age.  No additional information was available at the time of this report.									Y	09/15/2003	09/15/2003	0	UNK	PVT	PVT	Vitamin B12;	UNK	Hypersensitivity; Pernicious;		HQWYE170613OCT03	1						1	Pharyngolaryngeal pain; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216061	02/05/2004	NJ	68.0	68		M	11/13/2003	A female reported that her 68-year-old husband received a dose of Flumist (influenza virus vaccine, live intranasal (2003-2004 formula) 0n 15-Sep-2003. Medical history: The patient's concurrent illness includes pernicious anaemia. Product details: Indication for Flumist (2003-2004 Formula) was immunisation. Product was administered on 15-Sep-2003. Dose regimen was 0.5 mL (intranasal). Concomitant therapy: Concomitant therapy included Vitamin B12 (Cyanocobalamin and Derivatives). Event details: The caller's husband experienced sniffles and sore throat for 2 days following Flumist administration on 15-Sep-2003. The caller also expressed concern regarding the administration of Flumist to people with compromised immune systems and those who are over 50 years of age. No additional information was available at the time of this report.									Y	09/15/2003	09/15/2003	0	UNK	PVT	PVT	Vitamin B12 (Cyanocobalamin and derivatives)	UNK	Concurrent conditions: Pernicious anaemia		HQWYE1707	1						1	Pharyngolaryngeal pain; Rhinitis	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216062	02/05/2004		52.0	52		F	12/19/2003	A physician reported that a 52-year-old female patient received a dose of FLUMIST (2003-2004 Formula) on 05-NOV-2003 and experienced a respiratory infection which led to pneumonia.  On 07-Nov-2003, the patient developed a respiratory infection  which progressed to pneumonia . The patient was treated with intramuscular LEVAQUIN. The patient has not recovered. No additional information was available at the time of this report.									N	11/05/2003	11/07/2003	2	UNK	OTH	OTH	concomitant medications were not reported.	UNK	Relevant medical history was not provided. Product details: Indication for Flumist ( was immunization. Product was administered on 05-Nov-2003. Dose regimen was 1 dose (intranasal).		HQWYE19531	1						1	Pneumonia; Respiratory tract infection	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216063	02/05/2004	KY	5.0			F	10/24/2003	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a 5-year-old female patient who experienced gagging. At 5 years of age, the patient received the first dose of 14-Oct-2003. Medical history: Relevant medical history was not provided. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 14-Oct-2003. Dose regimen was 0.5 mL 1 times per day (intranasal). Concomitant therapy: Concomitant therapy included Tavist (clemastine fumarate). Event details: The patient gagged (retching) and some of the Flumist ran out of her nose on 14-Oct-2003. The patient is scheduled for her second dose. No additional information was available at the time of this report.									U	10/14/2003	10/14/2003	0		PVT	OTH	Tavist	UNK	UNK		HQWYE2572	1						1	Retching	FLUN3~MEDIMMUNE VACCINES, INC.~50001P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216064	02/05/2004	CT	27.0			F	12/19/2003	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 27-year-old white female patient who experienced hives, fever and sore throat. Medical history: Relevant medical history was not provided. Product details: Indication for Flumist (2003-2004 Formula) was immunisation. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant therapy: Concomitant medications were not reported. Event details: On 14-Nov-2003, the patient developed hives (urticaria), a fever (pyrexia) and sore throat (pharyngolaryngeal pain). She was treated with Benadryl. On a unspecified date, the patient recovered. No additional information was available at the time of this report.									Y		11/14/2003		UNK	OTH	OTH	UNK	UNK	UNK		HQWYE2945	1						1	Pharyngolaryngeal pain; Pyrexia; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500012P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216065	02/05/2004		10.0			M	12/11/2003	Information regarding Flu Mist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a parent regarding her 10-year-old son who experienced an awful tasted, watery eyes and gagging. Product was administered on an unspecified date. The reported also noted that the product did not come out as a spray, rather it squirted out. Medical history: Relevant medical history was not provided. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant therapy: Concomitant medications were not reported. Event details: The patient experienced taste (dysgeusia), eyes watery (lacrimation increased) and gag (retching) in Nov-2003. No additional information was available at the time of this report.									U		11/01/2003		UNK	OTH	OTH	UNK	UNK	UNK		HQWYE3073	1						1	Dysgeusia; Lacrimation increased; Retching	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216066	02/05/2004	KY				F	12/18/2003	Information regarding Flu Mist (2003-2004 Formula) (influenza virus vaccine. live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a female patient who received a dose of vaccine on an unspecified date and developed an ulcer under nostril. Medical history: Relevant medical history is not provided. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on an unspecified date. Dose regimen was 0.5 mL 1 time per day. Concomitant therapy: Concomitant medications were not reported. Event details: The patient experienced an ulcer under the nostril (ulcer) on the day of administration in 2003. He recovered. No additional information was available at the time of this report.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQWYE3081	1						1	Skin ulcer	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216067	02/05/2004	MD	26.0	26		M	12/15/2003	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a 26-year-old male who experienced blurred vision after receiving a dose on 12-Nov-2003. Medical history: Relevant medical history was not provided. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 12-Nov-2003. Dose regimen was 1 dose 1 time per day (nasal). Concomitant therapy: Concomitant medications were not reported. Event details: The patient experienced blurred vision (vision blurred) after receiving a dose on 12-Nov-2003. No additional information was available at the time of this report.									U	11/12/2003	11/12/2003	0	UNK	OTH	OTH	UNK	UNK	UNK		HQWYE3131	1						1	Vision blurred	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216068	02/05/2004	NJ	70.0	70		F	11/13/2003	A 70-year-old female reported that she inadvertently received a dose of Flumist (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) on 11-Oct-2003, and since then has had a stuffy nose and a headache. Medical History: relevant medical history was not provided. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 11-Oct-2003. Dose regimen was 1 dose (intranasal). Concomitant therapy: Concomitant therapy included Evista (raloxifene hydrochloride). Event details: On 11-Oct-2003, subsequent to Flumist administration, she developed stuffy nose (nasal congestion) and headache (headache). As of 15-Oct-2003, the events had not resolved. No additional information was available at the time of this report.									N	10/11/2003	10/11/2003	0	UNK	PVT	PVT	Evista	UNK	UNK		HQWYE3430	1						1	Headache; Medication error; Nasal congestion	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216069	02/05/2004	MD				U	12/11/2003	Information regarding Flumist nasal solution was received from a healthcare professional regarding a patient who received a dose on an unspecified day and month in 2003. It was reported the patient experienced a bad taste in the back of their mouth for a short while and product ran back out of both nostrils. Relevant medical history was not provided. Indication for Flumist was immunization. Product was administered on an unspecified day and month in 2003. Dose regimen was 0.5mL 1 time per day (nasal). Concomitant medications were not reported. The patient experienced bad taste in mouth in 2003. The reporter indicated that 8-9 patients between the ages of 5-18, experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.  No additional information was available at the time of this report.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQWYE350702DEC03	1						1	Dysgeusia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216070	02/05/2004	NJ	39.0	39		F	11/10/2003	A 39 year old female reported that she received a dose of Flumist nasal solution on 10/16/03 and experienced a strange taste in her mouth after vaccine administration. The patient's concurrent illnesses included hypothyroidism and post-nasal drip. Indication for Flumist was immunization. Product was administered on 10/16/03. Dose regimen was 0.5mL (IN). Concomitant therapy included Synthroid. Subsequently to Flumist administration, the patient reported that the Flumist tasted strange, and she continued to taste it for 30 minutes, up to the time of calling in this report. No additional information was available at the time of this report.									U	10/16/2003	10/16/2003	0	UNK	PVT	OTH	Synthroid	UNK	Hypothyroidism; Post nasal drip	Left arm sore and black and blue and swollen for 2 weeks~Influenza (Seasonal) (no brand name)~~38.00~In Patient	HQWYE376721OCT03	1						1	Dysgeusia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216071	02/05/2004					F	10/24/2003	A consumer reported that she received a dose of Flumist a couple of weeks ago and recently has developed a cold, productive cough, infected sinuses and ears. Relevant medical history was not provided. Indication for Flumist was immunization. Product was administered in 2003. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced cold, infected sinuses, ear infection, and productive cough in 2003. No additional information was available at the time of this report.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQWYE386121OCT03	1						1	Cough; Otitis media; Pharyngitis; Rhinitis; Sinusitis	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216072	02/05/2004	VA	46.0	46		F	11/12/2003	Information regarding Flumist was received from a healthcare professional regarding a 46 year old female pt who experienced lightheadedness, migraine headaches, blurred vision, body ache, sneezing and scratchy throat. At 46 years of age, the pt received a dose on 10/16/03. The pt's concurrent illness include migraine headaches, chronic back pain, hypothyroidism, and arthritis with a past history of sinusitis (frequent) and hysterectomy. The pt became lightheaded, and started having migraine headaches and blurred vision on 10/16/03. She then developed body aches, sneezing and a scratchy throat on 10/17/03. She recovered.									Y	10/16/2003	10/16/2003	0	UNK	OTH	OTH	Celebrex, Excedrin, Percocet, synthroid	UNK	Arthritis, back pain, hypothyroidism, migraine, hysterectomy, sinusitis.		HQWYE429722OCT03	1						1	Dizziness; Dry throat; Migraine; Pain; Sneezing; Vision blurred	FLUN3~MEDIMMUNE VACCINES, INC.~5000BP~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216073	02/05/2004	CA				M		Information regarding Flu Mist was received from a healthcare professional regarding her 4 year old son who experienced accidental exposure and developed a fever and dry cough. The mother, a pharmacist, reported that she administered the Flumist to patients in November, 2003. Two days later, she developed a cough. Three days after she developed a cough, her son developed fever and a dry cough. The mother reported that her 8 year old son also developed fever and cough at the same time. Neither the sons nor his mother received Flumist. Related cases: See HQWYE460108DEC03, and HQWYE460208DEC03. No additional info was available at the time of this report.									U		11/01/2003		UNK	OTH	OTH	UNK	UNK	UNK		HQWYE460008DEC03	1						1	Cough; Infection transmission via personal contact; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216074	02/05/2004	CA				M		Information regarding Flu Mist was received from a healthcare professional regarding her 8 year old son who experienced accidental exposure and developed a fever and dry cough. The mother, a pharmacist, reported that she administered the Flumist to patients in November, 2003. Two days later, she developed a cough. Three days after she developed a cough, her son developed fever and a dry cough. The fever resolved after 1 day the cough lasted several days. The mother reported that her 4 year old son also developed fever and cough at the same time. Neither the sons nor his mother received Flumist. Related cases: See HQWYE46008DEC03 and HQWYE460208DEC03. No additional info was available at the time of this report.									U		11/01/2003		UNK	OTH	OTH	UNK	UNK	UNK		HQWYE460108DEC03	1						1	Cough; Infection transmission via personal contact; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216075	02/05/2004	CA	37.0			F	12/16/2003	Information regarding Flu Mist was received from a healthcare professional regarding herself, a 37 year old female, who experienced accidental exposure and developed a dry hacky cough after administering Flu Mist. The pt experienced accidental exposure and developed a dry hacky cough in November, 2003. She reported that this occurred approximately 2 days after she administered Flu Mist to several people. she did not receive Flu Mist. Related cases: See HQWYE460108DEC03 and HQWYE46008DEC03. No additional info was available at the time of this report.									U		11/01/2003		UNK	OTH	OTH	UNK	UNK	UNK		HQWYE460208DEC03	1						1	Cough	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216076	02/05/2004	TX	13.0	13		F	12/15/2003	Follow up information received from the physician included additional events, medical history, patient date of birth, vaccines received within four weeks, and illnesses at the time of vaccination. Information regarding Flumist nasal solution was received from a healthcare professional regarding a 13 year old female patient who experienced a stuffy nose, a runny nose, abdominal pain, fever, and a sore throat. The patient also received product that was stored at a temperature that was higher than allowable and was not frozen. At 13 years of age, the patient received a dose on 10/18/03. The patient had no relevant medical history. Indication for Flumist was immunization. Product was administered on 10/18/03. Dose regimen was 1 dose 1 time per day (IN). Patient was not taking any concomitant therapy. The patient experienced a stuffy nose, a runny nose and abdominal pain on 10/19/03. She was treated with Triaminic. The patient also developed a temperature of 100.2 degrees F. The physician indicated that the patient received product that was stored by the pharmacy at a temperature that was higher than allowable and was not frozen.									Y	10/18/2003	10/19/2003	1	UNK	PVT	PVT	NONE	NONE	UNK	~Influenza (Seasonal) (FluMist)~~9.00~In Sibling	HQWYE467123OCT03	1						1	Abdominal pain; Nasal congestion; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216077	02/05/2004	MI	60.0	60		M	11/10/2003	Information regarding Flumist nasal solution was received from a healthcare professional regarding a 60 year old male who experienced slurred speech and saw spots before his eyes. At 60 years of age, the patient received a dose of 10/22/2003. The patient's concurrent illnesses include cardiac failure congestive, chronic obstructive airways disease, alcoholism, and alcohol intoxication. Indication for Flumist was immunization. Product was administered on 10/22/03. Dose regimen was 0.5mL 1 time per day (IN). Concomitant therapy included Lipitor, Vasotec, Acetylsalicylic Acid, Tenormin and sublingual NTG. The patient developed slurred speech and saw spots before his eyes on 10/22/03. No additional information was available at the date of this report.									U	10/22/2003	10/22/2003	0	UNK	PUB	PUB	Acetylsalicylic Acid; Lipitor; Nitro; Tenormin; Vasotec	UNK	Alcohol poisoning; Alcoholism; Cardiac failure congestive; Chronic obstructive airways disease		HQWYE468523OCT03	1						1	Dysarthria; Visual disturbance	FLUN3~MEDIMMUNE VACCINES, INC.~500014P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216078	02/05/2004	NJ	44.0	44		F	12/15/2003	Information regarding Flumist was received from a physician regarding his 44 year old wife who developed flu-like symptoms, nausea, stiffness, chills, low grade fever, laryngitis and cough following vaccine administration on 11/27/03. On 11/29/03, she developed flu-like symptoms characterized by nausea, stiffness (musculoskeletal stiffness), chills and low grade fever. On 12/3/03, she developed laryngitis. As of 12/4/03, the laryngitis, cough, and mild bronchitis symptoms persisted. No additional info was available at the time of this report.									U	11/27/2003	11/29/2003	2		PVT	PVT	NONE	NONE	UNK		HQWYE479909DEC03	1						1	Bronchitis; Chills; Cough; Influenza like illness; Laryngitis; Musculoskeletal stiffness; Nausea; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216079	02/05/2004	TX	9.0	9		M	11/18/2003	Follow-up info received provided the pt's date of birth, vaccinations receive within four weeks, medical history, and illness at the time of vaccination. Information regarding Flumist was received from a healthcare professional regarding a 9 year old male pt who experienced stuffy nose, runny nose. The pt received product that was stored at a temp that was higher than allowable and was not frozen. At 9 years of age, the pt received a dose on 10/18/03. The pt experienced stuffy nose and runny nose on 10/19/03. The pt's symptoms were treated with Triaminic. On 10/20/03, the pt had no complaints. The reporter indicated that the pt received product that was stored by the pharmacy at a temp that was higher than allowable and was not frozen.									Y	10/18/2003	10/19/2003	1	UNK	PVT	PVT	NONE	NONE	UNK		HQWYE480324OCT03	1						1	Medication error; Nasal congestion; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216080	02/05/2004					F	11/10/2003	Information has been received from a health care professional concerning a female pt who experienced postnasal sensation after receiving Flumist on 10/21/03. The pt experienced postnasal sensation on 10/21/03. No additional info was available at the time of this report.									U	10/21/2003	10/21/2003	0	UNK	OTH	OTH	UNK	UNK	UNK		HQWYE483024OCT03	1						1	Postnasal drip	FLUN3~MEDIMMUNE VACCINES, INC.~500014P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216081	02/05/2004	CA	49.0	49		F	12/16/2003	Information regarding Flumist was received from consumer regarding a 49 year old female pt who experienced sore throat with phlegm and fever < 100 deg. At 49 years of age, the pt received a dose on 12/2/03. The pt experienced sore throat with phlegm and fever < 100 deg on 12/3/03. The pt was treated with Tylenol but as of 12/3/03 the symptoms persisted. No additional info was available at the time of this report.									U	12/02/2003	12/03/2003	1	UNK	UNK	UNK					HQWYE495709DEC03	1						1	Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216082	02/05/2004	MD				M	12/18/2003	Information regarding Flumist was received from a male consumer, a physician, who received a dose on an unspecified date. The pt's physician, reported that he developed a rash, lower lip edema, and itchy watery eyes and lacrimation increased. No additional info was available at the time of this report.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQWYE522410DEC03	1						1	Face oedema; Lacrimal disorder; Lacrimation increased; Pruritus; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216083	02/05/2004	PA	29.0	29		F	11/10/2003	A 29 year old female consumer reported that she received a dose of Flumist on 10/20/03. The pt experienced stuffy nose, chest congestion, and sleeplessness on 10/22/03. As of the date of this report, the reporter indicated that she has recovered from chest congestion and has not recovered from stuffy nose and sleeplessness. No additional info was available at the time of this report.									N	10/20/2003	10/22/2003	2	UNK	OTH	OTH	Robitussin	UNK	UNK		HQWYE545427OCT03	1						1	Insomnia; Nasal congestion; Pulmonary congestion	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216084	02/05/2004	AL	38.0	38		M	12/19/2003	A 38 year old male pt reported that he received a dose of Flumist on 12/5/03. On 12/8/03, a 38 year old male pt developed dry, hacking cough, sinus congestion, slight headache, sore throat, muscle aches, chills, and burning eyes, tiredness and weakness following receipt of Flumist. As of 12/10/03, the pt's symptoms persisted. As of the date of this report, the prescribing physician has not been contacted. No additional info was available at the time of this report.									N	12/05/2003	12/08/2003	3	UNK	PVT	OTH	Protonix		GERD		HQWYE547011DEC03	1						1	Asthenia; Chills; Cough; Eye inflammation; Fatigue; Headache; Myalgia; Pharyngolaryngeal pain; Sinus congestion	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216085	02/05/2004	NV	49.0			F	12/16/2003	Information regarding Flumist was received from a medical technician regarding a 49 year old female co-worker who expereinced dizziness 10 minutes after receiving Flumist. At 49 years of age, the pt received a dose on 12/8/03. On 12/8/03, a female co-worker experienced dizziness about 10 minutes after receiving Flumist. She was feeling better a short time later. No additional info was available at the time of this report.									Y	12/08/2003	12/08/2003	0	UNK	PVT	OTH	NONE	UNK	UNK		HQWYE572112DEC03	1						1	Dizziness	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216086	02/05/2004					F	11/10/2003	Information regarding Flumist was received from a female pt who experienced an allergic reaction described as itching, redness on chest or hives, and light-headedness following receipt of Flumist. The pt indicated that Flumist was administered concomitantly with a cyst removal using lidocaine. The pt experienced allergic reaction, itching, redness on chest or hives, fatigue and light-headed. The pt indicated that Flumist was administered concomitantly with a cyst removal using lidocaine. No additional info was available at the time of this report.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQWYE572528OCT03	1						1	Dizziness; Erythema; Fatigue; Hypersensitivity; Pruritus; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216087	02/05/2004	MA	39.0	39		F	12/19/2003	A 39 year old female pt reported that she received a dose of Flumist on 12/8/03. The pt's concurrent illness includes hypersensitivity (allergic to Sudafed). The pt previously experienced heart rate increased, influenza like illness and headache while taking Sudafed. On 12/8/03, a 39 year old female pt reported that she experienced heart racing, flu-like symptoms and headache within minutes of receiving a dose of Flumist. The reporter stated that she experienced a similar reaction after receiving a dose of Sudafed in the past. The adverse events have not resolved. No additional info was available at the time of this report. Follow-up information was received on 09-Jan-2004 from the reported which provided additional adverse event information. A 39-year old female patient reported that she recieved a dose of Flumist (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on 08-Dec-2003 and experienced flu-like symtpoms, heart palpitations, headache, sweating, shortness of breath, and shaking. According to the reporter, the adverse events resolved withing twenty minutes after the receipt of Flumist. She stated that she experienced a similar reaction after receiving Sudafed. The patient reported that on two previous occassions, after the adminstration of Sudafed, she was seen in an emergency room for her allergy. She reported that she did not seek treatment for the adverse events related to the administration FluMist.									N	12/08/2003	12/08/2003	0		OTH	PVT	NONE	UNK	Hypersensitivity. The reporter indicated that she is allergic to Sudafed. In the past, she has experienced heart palpitations, flu-like symptoms, headache, sweating, shortness of breath and shaking after Sudafed administration.		HQWYE572812DEC03	1						1	Headache; Heart rate increased; Influenza like illness	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216088	02/05/2004	FL	20.0			F	12/16/2003	Information regarding Flumist was received from a healthcare professional regarding a 20 year old female pt who experienced nausea, vomiting, and headache. At 20 years of age, the pt received a dose on 12/9/03. On 12/9/03, approximately one hour post vaccination, the pt experienced nausea, vomiting, and a headache. The pt still had a headache about four hours after vaccine administration. No additional info was available at the date of this report.									U	12/09/2003	12/09/2003	0	UNK	OTH	OTH	UNK	UNK	UNK		HQWYE587312DEC03	1						1	Headache; Nausea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500019B~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216089	02/05/2004	IA	9.0	9		M	12/15/2003	Follow-up info received from the pt's physician provided the following: adverse event info including symptoms, onset, and recovery status; pt's gender and date of birth; concomitant medications; illnesses at the time of vaccination; and medical history. A health care professional reported that a 9 year old male pt received a dose of Flumist on an unspecified date in Oct 2003, and experienced flu-like symptoms, sore throat, ear congestion, runny nose, cough, nausea, vomiting, and loose stools. Within 24 hrs of vaccination, the pt experienced flu-like symptoms, sore throat, ear congestion, runny nose, cough, nausea, vomiting and loose stools. The symptoms lasted more than five days. The pt has recovered.									Y	10/01/2003			UNK	PVT	OTH	NONE	NONE	UNK		HQWYE626029OCT03	1						1	Cough; Diarrhoea; Influenza like illness; Nasal congestion; Nausea; Pharyngolaryngeal pain; Rhinorrhoea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216091	02/05/2004	NY				F	12/18/2003	Information regarding Flumist was received from a consumer regarding a female pt who experienced a slight rash and a heat-type rash, which she scratched until it bled. Also, the tops of legs and groin area had become irritated and inflamed. The pt received a dose on 12/9/03. On 12/9/03, about two hours post vaccination, the pt developed a slight rash on the inside of her elbow joint. Three hrs post vaccination she developed a heat-type rash under her breasts. Then, about four hrs post vaccination, the tops of her legs and groin area had become irritated and inflamed. The pt stated that she has scratched until she bled in some parts. As of 12/10/03, the pt had not recovered. No additional info was available at the date of this report.									N	12/09/2003	12/09/2003	0	UNK	OTH	OTH	UNK	UNK	UNK		HQWYE637916DEC03	1						1	Rash; Skin irritation; Skin warm	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216092	02/05/2004	CA	31.0			F	12/19/2003	Information regarding Flumist was received from a healthcare professional regarding a 31 year old female pt who experienced mouth numbness, tingling of mouth and headache. At 31 years of age, the pt received the first dose on 12/10/03. Five minutes post-immunization, the pt experienced mouth numbness, tingling of mouth and headache. The reporter indicated that the pt was not allergic to eggs and has no history of reactive airway disease. The reporter also indicated that the pt has never had influenza vaccine prior to this event. No additional info was available at the time of this report.									U	12/10/2003	12/10/2003	0	UNK	OTH	OTH	NONE	NONE	UNK		HQWYE639916DEC03	1						1	Headache; Hypoaesthesia; Paraesthesia	FLUN3~MEDIMMUNE VACCINES, INC.~500020P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216093	02/05/2004	GA	48.0			F	12/19/2003	A 48 year old female report that she received a dose of Flumist and on 12/10/03, experienced a severe bloody nose. On 12/10/03, the reporter experienced a severe bloody nose, after receiving a dose of Flumist. No additional info was available at the time of this report.									U		12/10/2003		UNK	OTH	OTH	UNK	UNK	UNK		HQWYE643116DEC03	1						1	Epistaxis	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216094	02/05/2004	CO	32.0	32		F	12/19/2003	A 32 year old female reported that she received a dose of Flumist on 12/8/03, and experienced feeling like I was coming down with a cold afterward. On 12/10/03, 2 days post-immunization, the reporter experienced feeling like I was coming down with a cold, characterized by sneezing, nasal congestion, and dry throat. As of 12/11/03, all symptoms were unresolved. No additional info was available at the time of this report.									N	12/08/2003	12/10/2003	2	UNK	PUB	PUB	Propranolol	UNK	Headache, seasonal allergy		HQWYE648816DEC03	1						1	Dry throat; Nasal congestion; Pharyngitis; Rhinitis; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216095	02/05/2004	UT	6.0			M	12/19/2003	Information regarding Flumist was received from a healthcare professional regarding a 6 year old male pt who experienced sinus symptoms and a stiff neck. At 6 years of age, the pt received a dose on 12/10/03. The pt developed sinus symptoms and a stiff neck during the night on 12/10/03. The reporter noted that the physician did not feel that the events were related to Flumist. No additional info was available at the date of this report.									U	12/10/2003	12/10/2003	0	UNK	PVT	OTH	NONE	UNK	UNK		HQWYE651316DEC03	1						1	Musculoskeletal stiffness; Sinusitis	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216096	02/05/2004	NC	6.0	6		F	12/19/2003	Information regarding Flumist was received from a healthcare professional regarding a 6 year old female pt who experienced redness in the neck. The pt received a dose on 12/11/03. The patient's neck turned red immediately after receiving the Flumist on 12/11/03. The nurse stated that the tp said she felt fine. The nurse indicated that there was no sign of a rash, just redness. No additional info was available at the date of this report.									U	12/11/2003	12/11/2003	0	UNK	PVT	OTH	UNK	UNK	UNK		HQWYE651516DEC03	1						1	Erythema	FLUN3~MEDIMMUNE VACCINES, INC.~500012P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216097	02/05/2004	MA				F	12/18/2003	A physician reported that she administered Flumist to 3 students on 12/11/03 and later experienced flu-like symptoms characterized by myalgias, chills, sweats and nausea. On 12/11/03, the reporter (a physician), administered Flumist to 3 students at the student health center, and then stayed with the students in the same room for about an hour. At 7pm that night, she started to get flu-like symptoms, experiencing myalgias, chills, sweats and nausea. She took no medications to treat her symptoms. The next morning, she was still not feeling better and was not able to go to work. She was feeling a lot better at the time of this report. She was concerned about whether she developed her flu-like symptoms as a result of administering Flumist. No additional info was available at the time of this report.									U		12/11/2003		UNK	OTH	OTH	Tegretal	UNK	UNK		HQWYE655016DEC03	1						1	Chills; Hyperhidrosis; Influenza like illness; Myalgia; Nausea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216098	02/05/2004	OH	22.0	22		M	12/19/2003	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a 22 year old male pt who experienced nausea, vomiting, dizziness, near syncope, generalized weakness, headache, and tiredness.  At 22 years of age, the pt received a dose on 12/11/03.  The pt has a past history of syncope vasovagal.  The pt had no history of egg allergy.  He had passed out previously when having blood drawn.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/11/03.  Dose regimen was 1 dose (IN).  Concomitant therapy included Zirtec (cetirizine hydrochloride).  The pt experienced nausea, vomiting, dizziness, near syncope, generalized weakness, headache, and tiredness on 12/11/03.  No additional information was available at the date of this report.									U	12/11/2003	12/11/2003	0	UNK	OTH	OTH	Zirtec;	UNK	Syncope vasovagal;		HQWYE658316DEC03	1						1	Asthenia; Dizziness; Fatigue; Headache; Nausea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216099	02/05/2004	CA	11.0			F	01/06/2004	A pharmacist reported that an 11 year old female pt inadvertently received a dose of Flumist (influenza virus vaccine, live intranasal (2003-2004 Formula) nasal solution (frozen)) into a single nostril on 12/12/2003.  The reporter indicated that the pt does not have any relevant medical history.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/12/03.  Concomitant medications were not reported.  Concomitant vaccines were not administered.  On 12/12/03, a female pt inadvertently received a dose of Flumist into a single nostril.  The reporter indicated that the pt stated the Flumist tasted sweet right after administration.  No additional information was available at the time of this report.									U	12/12/2003			UNK	OTH	OTH	UNK	UNK	UNK		HQWYE659816DEC03	1						1	Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~500034P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216100	02/05/2004	AL	49.0	49		F	12/19/2003	A consumer reported that a 49 year old female pt received a dose of Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 Formula) nasal solution (frozen)) on 12/11/03.  The pt's concurrent illnesses include hypersensitivity (allergy to PCN and Ceftin), depression (dysthymia), ADHD and mitral valve prolapse with a past history of hysterectomy (five years ago).  The pt has no known food allergies.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/11/03.  Dose regimen was 0.5mL 1 time per day (IN).  Concomitant therapy included Premarin, Paxil and Adderall.  Concomitant vaccine were not administered.  On 12/12/03, a 49 year old female experienced a puffed up left eye after receiving a dose of Flumist.  The reporter stated that her left eye was swollen, but with no redness, drainage, or itching.  The adverse event has not resolved.  No additional information was available at the time of this report.									N	12/11/2003	12/12/2003	1	UNK	PVT	PVT	Adderall; Klonopin; Paxil; Premarin;	UNK	ADHD; Depression; Hypersensitivity; Mitral valve prolapse; Hysterectomy;		HQWYE677217DEC03	1						1	Eye oedema	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216101	02/05/2004	CA	40.0	40		M	12/19/2003	A 40 year old male pt reported that he received a dose of Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on 12/10/03.  The pt has no known drug allergies.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/10/03.  Dose regimen was 1 dose 1 time per day (intranasal).  Concomitant medications were not reported.  On 12/11/03, a 40 year old pt developed a rash in and around the right nostril after receiving a dose of Flumist.  The reporter states that the rash is red and raised and hurts when touched.  The rash covers 1/16 inch on the inside of the right nostril and 1/4 inch on the outside of the right nostril.  The rash extends up and around the right nostril, and the nose is inflamed on the right side.  No additional information was available at the time of this report.									U	12/10/2003	12/11/2003	1	UNK	OTH	PVT	UNK	UNK	UNK		HQWYE677617DEC03	1						1	Inflammation; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216102	02/05/2004	IL	7.0			F	12/11/2003	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 7 year old female pt who experienced nasal congestion, feeling lethargic and cough.  At 7 years of age, the pt received a dose on 10/16/03.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 10/16/03.  Dose regimen was 1 dose intranasal.  Pt was not taking concomitant therapy.  The pt experienced nasal congestion (nasal congestion), feeling lethargic (lethargy), and cough (cough) on 10/16/03.  The pt's mother stated that she doesn't know if these events are related to Flumist or seasonal allergy or cold. As of 10/29/03, the pt's symptoms persisted.  No additional information was available at the date of this report.									N	10/16/2003	10/16/2003	0	UNK	PVT	OTH	NONE	UNK	UNK		HQWYE677931OCT03	1						1	Cough; Lethargy; Nasal congestion	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216103	02/05/2004	IL	5.0			M	12/11/2003	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 5 year old male pt who experienced nasal congestion, feeling lethargic and cough.  At 5 years of age, the pt received a dose on 10/16/03.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 10/16/03.  Dose regimen was 1 dose (IN).  Pt was not taking concomitant therapy.  The pt experienced nasal congestion (nasal congestion), feeling lethargic (lethargy) and cough (cough) on 10/16/03.  The pt's mother stated that she did not know if the events were related to Flumist or to seasonal allergy or cold.  As of 10/29/03, the pt's symptoms persisted.  No additional information was available at the time of date report.									N	10/16/2003	10/16/2003	0	UNK	PVT	OTH	NONE	UNK	UNK		HQWYE678131OCT03	1						1	Cough; Lethargy; Nasal congestion	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216104	02/05/2004	KY	8.0	8		M	12/18/2003	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a father regarding his 8 year old son who experienced fever of 99-100, sore throat, headache, coughing and more raspy breathing.  At 8 years of age, the pt received a dose on 12/08/03.  The pt's concurrent illness includes seasonal asthma (October to April).  Indication for Flumist (2003-2004 formula) was immunization. Product was administered on 12/08/03.  Dose regimen was 0.5mL (IN).  Concomitant therapy included Albuterol.  On the evening of 12/11/03, 3 days post-immunization, the child experienced coughing, more raspy breathing, fever of 99-100, sore throat and headache.  He was treated with albuterol nebulizer and given Children's Advil.  No additional information was available at the time of this report.									U	12/08/2003	12/11/2003	3	UNK	PVT	PVT	Albuterol;	UNK	Asthma;		HQWYE680317DEC03	1						1	Cough; Headache; Pharyngolaryngeal pain; Pyrexia; Respiratory disorder	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216105	02/05/2004	CA	16.0	16		M	12/23/2003	Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a parent regarding her 16 year old son who experienced leg buckling, felt like passing out, vomiting and blood sugar increased.  At 16 years of age, he received a dose on 12/11/03.  The pt's concurrent illness include diabetes melllitus since 4 years of age.  The reporter indicated that her son's blood sugar goes up and down routinely.  The reporter indicated that her 8 year old daughter developed a stomach bug on 12/10/03.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/11/03.  Dose regimen was 0.5mL 1 time per day IN.  Concomitant therapy included Lantus and Novolog.  The pt woke up on the morning of 12/12/03, and experienced leg buckling, vomiting, and he felt like passing out.  A blood sugar reading of 392 was higher than normal (blood glucose increased)(condition aggravated).  He was given 8 units of Novolog.  Later that same day, another fasting blood sugar reading was 145.  The reporter indicated that her son was resting in bed and felt better. Follow-up information received from the reporter on 05-Jan-2004 provided the lot number and information on previous doses of vaccines. The reported stated that the patient recovered.									U	12/11/2003	12/12/2003	1	Blood glucose: Fasting blood sugar reading was 392, higher than normal; Blood glucose: fasting blood sugar reading, taken later on the same day, was 145.  These were done on 12/12/03.  No additional information was available at the time of this report.	OTH	OTH	Lantus; Novolog;	UNK	Diabetes mellitus since 4 years of age. The reporter indicated that her son's blood sugar goes up and down routinely. The reporter indicated that her 8-year-old daughter developed a stomach bug on 10-Dec-2003.		HQWYE681917DEC03	1						1	Blood glucose increased; Dizziness; Gait disturbance; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216106	02/05/2004	CA	5.0	5		F	12/18/2003	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a father regarding his 5 year old daughter who experienced fever, weakness, tiredness, runny nose, sore throat, and swollen throat.  At 5 years of age, the pt received a dose on 12/10/03.  The pt had no relevant medical history.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/10/03.  Dose regimen was 1 dose 1 time per day (IN).  Pt was not taking concomitant therapy.  On 12/11/03, the pt was sent home from school due to weakness and tiredness.  Later that same day, she developed a runny nose, sore throat, and swollen throat.  That night she woke up with a fever of 103 deg F.  As of 12/12/03, she still had a fever of 99 deg F, runny nose and sore, swollen throat.  No additional information was available at the date of this report. Follow-up information received on 16-Jan-2004 from the reporter provided the child's birth weigh, sibling information, previous vaccine adverse event history, and recovery status. The child's father indicated that more than half of the patient's classmates had become ill with the flu at the time his daughter was ill. The reporting father indicated that his daughter's pediatrician commented that it was likely she had already been exposed to the flu prior to FluMist adminstration. Through the course of her illness she experienced high fevers of 104 deg. F. for several days, and was well by the fifth day.									U	12/10/2003	12/11/2003	1	UNK	OTH	PVT	NONE	UNK	UNK		HQWYE687017DEC03	1						1	Asthenia; Fatigue; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea; Tracheal oedema	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216107	02/05/2004	NJ	9.0	9		F	12/19/2003	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a father regarding his 9 year old daughter who experienced bleeding and watery discharge from the right nostril.  At 9 years of age, the pt received a dose on 12/12/03.  The pt had no history of nose bleeds.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/12/03.  Dose regimen was 1 dose (IN).  Concomitant medications were not reported.  On 12/12/03, about thirty minutes after Flumist administration, the pt started bleeding from the right nostril (epistaxis).  A compress was applied and after about three minutes the bleeding stopped.  The father stated that since then, the pt has had some watery discharge from the right nostril.  No additional information was available at the date of this report. Follow-up information received from the patient's physician provided vaccine lot number and concomitant medications. Concomitant Therapy: Concomitant therapy included Poly-Vi-Flor (ascorbic acid/ergocalciferol/nicotinamide/potassium flouride/retinol/riboflavin/thiamine hydrochloride). Event Details: On 12-Dec-2003, about thirty minutes after Flumist administration, the patient started bleeding from the right nostril (epistaxis). A compress was applied after about three minutes the bleeding stopped. The father stated that since the, the patient has had some watery discharge (rhinorrhoea) from the right nostril.									U	12/12/2003	12/12/2003	0	UNK	PVT	OTH	UNK	UNK	Medical History: The patient has no history of nose bleeds.		HQWYE688217DEC03	1						1	Epistaxis	FLUN3~MEDIMMUNE VACCINES, INC.~50017P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216108	02/05/2004	FL				F	12/19/2003	Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a female student who experienced fever, headache, nasal congestion, swollen tonsilar glands, sore throat and vomiting.  The pt received a dose on 12/11/03.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/11/03.  Dose regimen was 1 dose 1 time per day (IN).  Pt was not taking concomitant therapy.  The pt experienced fever subjectively higher over the weekend than a temperature of 99.1 deg F on 12/16/03.  She also developed headache, nasal congestion, swollen tonsilar glands, sore throat and two episodes of vomiting on 12/13/03.  No additional information was available at the time of this report.									U	12/11/2003	12/13/2003	2	UNK	OTH	OTH	NONE	UNK	UNK		HQWYE690917DEC03	1						1	Headache; Lymphadenopathy; Nasal congestion; Pharyngolaryngeal pain; Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216109	02/05/2004	GA	62.0	62		F	12/18/2003	Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 62 year old female pt who experienced sneezing, runny nose, aching teeth, swollen left eye and watery left eye.  At 62 years of age, the pt received a dose on 12/12/03.  The pt has a past history of migraine headaches.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/12/03.  Dose regimen was 1 dose (IN).  Concomitant medications were not reported.  The pt experienced sneezing on 12/12/03, and runny nose on 12/13/03.  On 12/16/03, her nose was extremely runny, her left eye was swollen and watery and her teeth on the left side ached.  No additional information was available at the time of this report.									U	12/12/2003	12/12/2003	0	UNK	PVT	OTH	UNK	UNK	Migraine;		HQWYE692317DEC03	1						1	Eye oedema; Lacrimation increased; Rhinorrhoea; Sneezing; Toothache	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216110	02/05/2004	MI	38.0	38		M	12/19/2003	Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 38 year old male pt who experienced Flumist administered incorrectly and both biceps mildly sore.  At 38 years of age, the pt received a dose on 12/15/03.  The pt had no relevant medical history.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/15/03.  Dose regimen was 1 dose (IN).  Pt was not taking concomitant therapy.  On 12/15/03, the caller reported that after Flumist was administered to him, the liquid ran down his cheeks and upper lip and into his mouth, and some drained down his throat.  He stated the administration was incorrect.  On 12/16/03, 15 hours post-immunization, both of his biceps were mildly sore, and the continued to be mildly sore at the time of this report.  No additional information was available at the time of this report. Follow-up information received from the physician confirmed a problem with administration. He stated the administration was incorrect and he did not receive a half dose in each nostril. On 16-Dec-2003, 15 hours post-immunization, both of his biceps were mildly sore. On follow-up, the physician confirmed the problem with administration. No additional information was available at the time of this report.									U	12/15/2003	12/16/2003	1	UNK	PVT	PVT	NONE	NONE	UNK		HQWYE692517DEC03	1						1	Medication error; Myalgia; Postnasal drip	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216111	02/05/2004	VA	8.0	8		M	12/19/2003	Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding an 8 year old male pt who experienced fever of 101 deg F, stuffy nose, cough and acting hyper.  At 8 years of age, the pt received a dose on 12/13/03.  The pt had no relevant medical history.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/13/03.  Dose regimen was 0.5mL (IN).  Pt was not taking concomitant therapy.  On 12/15/03, 2 days post-immunization, the child had a low grade fever and was sent home from school on 12/16/03, with a fever of 101 deg F, stuffy nose, acting hyper and cough.  He was treated with Tylenol.  No additional information was available at the time of this report. Follow-up information received from the child's mother provided an additional symptom of a rash behind her son's knees which started on 19-Dec-2003. On 19-Dec-2003, the child developed a rash behind his knees, which appeared worse on 21-Dec-2003. The rash is currently being treated with Benedryl cream (diphenhydramine). No additional information was available at the time of this report.									U	12/13/2003	12/15/2003	2	UNK	PVT	OTH	NONE	NONE	UNK. Medical History: The patient has no relevant medical history.		HQWYE693717DEC03	1						1	Cough; Nasal congestion; Psychomotor hyperactivity; Pyrexia; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216112	02/05/2004	MI	17.0	17		F	12/19/2003	Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her 17 year old daughter who experienced chills, nasal congestion, nasal drainage, and sleeping longer.  At 17 years of age, the pt received a dose on 12/13/03.  The pt's concurrent illness includes seasonal allergy.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/13/03.  Dose regimen was 1 dose 1 (IN).  Concomitant therapy included Claritin.  The pt experienced chills, nasal congestion, nasal drainage, and sleeping longer on 12/15/03.  The mother reported that her daughter slept twelve hours on the night on 12/15/03 and had to stay home from school on 12/16/03.  The mother indicated that Sudafed and Claritin have not helped with the congestion and drainage.  No additional information was available at the date of this report. Follow-up information received from the patient's mother provided additional event details and physician information. On 15-Dec-2003, the patient developed a flu like cold (influenza like illness), chills (rigors), nasal congestion (nasal congestion), nasal drainage (nasal sinus drainage) and sleeping longer (somnolence). The mother reported that her daughter slept twelve hours on the night of 15-Dec-2003 and had to stay home from school on 16-Dec-2003. The mother indicated that Sudafed (psudoephedrine) and Claritin have not helped with the congestion and drainage. The mother reported that the symptoms lasted for three days, and the patient did not see a physician. No additional information was available at the date of this report.  The physician reported taht the patient recovered.									U	12/13/2003	12/15/2003	2	UNK	PVT	OTH	Claritin;	UNK	Seasonal allergy;		HQWYE693917DEC03	1						1	Chills; Influenza like illness; Nasal congestion; Rhinorrhoea; Somnolence	FLUN3~MEDIMMUNE VACCINES, INC.~500032P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216113	02/05/2004	OH	26.0	26		F	12/19/2003	Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a 26 year old female consumer who received a dose on 12/13/03.  The pt has a past history of nasopharyngitis.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/13/03.  Dose regimen was 0.5mL 1 time per day (IN).  Pt was not taking concomitant therapy.  It was reported by a 26 year old female consumer that on 12/13/03, she received a dose of Flumist.  On 12/15/03, she developed fever, coughing, feeling bad and head feeling foggy (feeling abnormal), chills, cold sweats, weakness and felt woozy.  By approximately 1-2am on 12/16/03, she reported that her fever broke.  As of 12/16/03, the cough persists.  No additional information was available at the time of this report. Follow-up information received from a healthcare professional on 13-Jan-2004 states, Patient recovered without complications.									U	12/13/2003	12/15/2003	2	UNK	PVT	OTH	NONE	UNK	Nasopharyngitis;		HQWYE694217DEC03	1						1	Asthenia; Chills; Cough; Dizziness; Feeling abnormal; Hyperhidrosis; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216114	02/05/2004	PA	23.0	23		F	12/19/2003	Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her 23 year old daughter who experienced dry nostrils that felt like they were scabbing, and bleeding from both nostrils.  At 23 years of age, the pt received a dose on 12/15/03.  The pt had no history of nose bleeds.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/15/03.  Dose regimen was 1 dose (IN).  Concomitant medications were not reported.  On 12/16/03, the pt experienced dry nostrils (nasal dryness) that felt like they were scabbing (scab).  When she blew her nose, there was a lot bleeding from both nostrils (epistaxis).  The mother reported that the bleeding soon stopped.  No additional information was available at the date of this report. Follow-up information received from the patient provided physician name and address.									U	12/15/2003	12/16/2003	1	UNK	OTH	OTH	UNK	UNK	Medical History: The patient has no history of nose bleeds.		HQWYE699117DEC03	1						1	Epistaxis; Nasal dryness	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216115	02/05/2004	NC	60.0	60		F	12/15/2003	Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a 60 year old female pt who experienced a bad headache immediately following inadvertent administration.  She also developed muscle pain, fatigue, chills, a cold, and a runny nose. The pt received a dose on 10/31/03.  The pt's concurrent illnesses include increased intraocular pressure and osteoporosis.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 10/31/03.  Dose regimen was 0.25mL each nostril (IN).  Concomitant therapy included Evista, Paxil, Aciphex, Metamucil, Vitamin C, Vitamin E, Vitamin A, Vitamin D and calcium plus Vitamin D.  On 10/31/03, the pt developed a bad headache, which she described as severe, that began immediately after she sniffed the Flumist.  She indicated that she could taste the Flumist, but this only lasted a few minutes.  She also developed muscle pain (myalgia), fatigue, chills and runny nose and a cold which lasted a few days.  She recovered from all of the events.  The pt stated that Flumist was inadvertently administered (medication error) because she was not aware that it was a live virus vaccine or that it was not indicated for pt's her age.									Y	10/31/2003	10/31/2003	0	UNK	OTH	OTH	Aciphex; Caltrate 600 + Vitamin D; Evista; Metamucil; Paxil; Vitamins: A, C, D, E	UNK	Intraocular pressure increased; Osteoporosis;		HQWYE69930NOV03	1						1	Chills; Fatigue; Headache; Malaise; Medication error; Myalgia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216116	02/05/2004		27.0			F	12/19/2003	A 27 year old female pt reported that she received a dose of Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on an unspecified date. Relevant medical history was not provided.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on an unspecified date.  Dose regimen was 1 dose 1 time per day (IN).  Concomitant therapy included Protonix.  Lab test results: influenza test positive was done on an unspecified date.  On an unspecified date in Dec 03, a 27 year old female pt developed influenza after receiving a dose of Flumist.  Treatment consisted of Tylenol and Levall.  The reporter indicated that she found out she was pregnant soon after the administration of the Flumist vaccine.  No additional information was available at the time of this report. As of 14-Jan-2004, she has recovered from influenza.									U				Lab test results: Influenza test positive;	OTH	OTH	Protonix;	UNK	The patient has a history of oral contraceptive use. All other relevant medical history was not provided.		HQWYE715418DEC03	1						1	Influenza; Laboratory test abnormal; Unintended pregnancy	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216117	02/05/2004					U	12/19/2003	Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a pt who experienced rash on neck.  The pt received vaccine on an unspecified date.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on an unspecified date.  Dose regimen was not provided.  Concomitant medications were not reported.  The pt experienced rash on neck (rash).  The reporter declined to provide information in order to conduct follow-up.  No additional information was available at the time of this report.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQWYE725118DEC03	1						1	Rash	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216118	02/05/2004	MI	36.0	36		F	12/19/2003	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 36-year-old female patient who experienced flu-like symptoms. At 36 years of age, the patient received a dose on 15-Dec-2003. Medical history: The patient had no relevant medical history. She reported she does not have an egg allergy. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 15-Dec-2003. Dose regimen was 1 dose (intranasal). Concomitant therapy: Concomitant therapy included Yasmin (drospirenone/ethinyl estradiol). Event details: The patient experienced flu-like symptoms (influenza like illness) characterized by dizziness (dizziness), weakness (asthenia) and chills (rigors) on 15-Dec-2003. She went to the emergency room but was not seen. As of 15-Dec-2003, the events had not resolved. No additional information was available at the time of this report.									U	12/15/2003	12/15/2003	0	UNK	PUB	PVT	Yasmin	NONE	UNK		HQWYE7254	1						1	Asthenia; Chills; Dizziness; Drug ineffective; Influenza like illness	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216119	02/05/2004	OH	40.0	40		F	12/19/2003	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 40-year-old female patient who experienced abdominal pain and cramping, diarrhea and nausea. At 40 years of age, the patient received a dose on 08-Dec-2003. Medical history: The patient's concurrent illness includes back pain. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 08-Dec-2003. Dose regimen was 1 dose (intranasal). Concomitant therapy: Concomitant therapy included Celebrex (celecoxib) and Wellbutrin XL (amfebutamone hydrochloride). Event details: The patient experienced abdominal pain and cramping (abdominal pain), diarrhea (diarrhoea) and nausea (nausea) on 15-Dec-2003. As of 15-Dec-2003, her symptoms continued. No additional information was available at the date of this report.									N	12/08/2003	12/15/2003	7	UNK	OTH	PVT	Celebrex, Wellbutrin-slow release.	UNK	Concurrent Conditions: Back pain.		HQWYE7266	1						1	Abdominal pain; Diarrhoea; Nausea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216120	02/05/2004	OH	13.0	13		F	12/19/2003	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 13-year-old female patient who experienced diarrhea, abdominal pain and cramping and nausea. At 13 years of age, the patient received a dose on 08-Dec-2003. Medical history: The patient has no relevant medical history. Product details: Indication for Flumist (2003-2004) was immunization. Product was administered on 08-Dec-2003. Dose regimen was 1 dose (intranasal). Concomitant therapy: Patient was not taking concomitant therapy. Event details: the patient experienced diarrhea (diarrhoea), abdominal pain and cramping (abdominal pain) and nausea (nausea) on 14-Dec-2003. As of 15-Dec-2003, her frequent bowel movements have continued. No additional information was available at the date of this report.									U	12/08/2003	12/14/2003	6	UNK	OTH	PVT	NONE	UNK	UNK		HQWYE7267	1						1	Abdominal pain; Diarrhoea; Nausea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216121	02/05/2004	IN	49.0	49		F	12/18/2003	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a 49-year-old female patient who experienced pain in her eyeball, dizziness, unable to get out of bed, dry cough and nausea. At 49 years of age, the patient received a dose on 10-Dec-2003. Medical history: The patient has no relevant medical history. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 10-Dec-2003. Dose regimen was 1 dose (intranasal). Concomitant therapy: Patient was not taking concomitant therapy. Event details: The patient experienced pain in her eyeball (eye pain) immediately after receiving Flumist on 10-Dec-2003. That same night the patient was dizzy (dizziness), unable to get out of bed (asthenia), and developed a dry cough (cough) and nausea (nausea). As of 15-Dec-2003, her dry cough and nausea persisted. No additional information was available at the date of this report.									U	12/10/2003	12/10/2003	0	UNK	PVT	OTH	UNK	UNK	UNK		HQWYE7274	1						1	Asthenia; Cough; Dizziness; Eye pain; Nausea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216122	02/05/2004	NJ	9.0	9		F	12/19/2003	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her 9-year-old daughter who developed the flu. At 9 years of age, the patient received a dose on 11-Dec-2003. Medical History: The patient had no relevant medical history. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 11-Dec-2003. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: A mother reported that on 13-Dec-2003, 2 days post-immunization, her daughter developed the flu. the child developed a wicked headache, muscle aches, clear runny nose, sneezing and a fever of 102.5 deg. F. On 14-Dec-2003, her temperature increase to 103.5 deg F. The headache resolved with Tylenol (acetaminophen) and cool packs, but the other symptoms continued. Later on 14-Dec-2003, her fever was 101.7 and the runny nose continued. No additional information was available at the date of this report.									N	12/11/2003	12/13/2003	2	UNK	PVT	OTH	UNK	UNK	UNK		HQWYE7278	1						1	Body temperature increased; Drug ineffective; Headache; Influenza; Myalgia; Pyrexia; Rhinorrhoea; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216123	02/05/2004	IL	33.0	33		F	12/19/2003	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a nurse regarding a 33-year-old female patient who experienced fever of 103 F., her body ached and nasal congestion. At 33 years of age, the patient received a dose on 12-Dec-2003. Medical History: Relevant medical history was not provided. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 12-Dec-2003. Dose regimen was 1 dose (nasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: On the evening of 12-Dec-2003, after receiving Flumist, the patient started to feel sick. During the night, she developed a fever of 103 degrees F., her body ached and she had nasal congestion. On 14-Dec-2003, her fever was 101 degrees F. On the morning of 15-Dec-2003, the patient no longer had a fever and she began to feel better. It is unknown if any treatment medications were taken. No additional information was available at the time of this report.									U	12/12/2003	12/12/2003	0	UNK	PVT	PVT	NONE	UNK	UNK		HQWYE7281	1						1	Malaise; Nasal congestion; Pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500013P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216124	02/05/2004	NC				F	12/19/2003	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding an adult female patient who experienced itchy eyes about 5 minutes after receiving Flumist. The patient received a dose on an unspecified date. Medical History: Relevant medical history was not provided. Product Details: Indication for Flumist (2003-2004 Formula) was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant Therapy: Concomitant medications were not reported. Event Details: The patient experienced itchy eyes about 5 minutes after receiving Flumist. As soon as she itched her eyes, there were fine. The reporter indicated that the patient's son also experienced this same event. Related case(s): See related case: HQWYE753718DEC03 (adverse event, non-expedited). No additional information was available at the time of this report.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQWYE7284	1						1	Eye irritation; Pruritus	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216125	02/05/2004	SC	53.0	53		F	12/19/2003	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 53-year-old female patient who experienced stuffy head (feeling like her head was packed with cotton), feeling achy, chills and sore throat. At 53 years of age, the patient received a dose on 11-Dec-2003. Medical History: The patient's concurrent illness includes unspecified allergies. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 11-Dec-2003. Dose regimen was 1 dose (intranasal). Concomitant Therapy: Concomitant therapy included Claritin (loratadine). Event Details: On 14-Dec-2003, 3 days post-immunization, the patient developed symptoms of stuffy head (feeling like her head was packed with cotton), feeling achy, chills, and sore throat. No additional information was available at the time of this report.									U	12/11/2003	12/14/2003	3	UNK	PVT	OTH	Claritin	UNK	Concurrent Conditions: Hypersensitivity		HQWYE7287	1						1	Chills; Headache; Pain; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216126	02/05/2004	CA	33.0	33		M	12/19/2003	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a 33-year-old male consumer who experienced headache, feeling tired and achy. At 33 years of age, the patient received a dose on 09-Dec-2003. Medical History: Relevant medical history was not provided. Product Details: Indication for Flumist (2003-2004 Formula) was immunisation. Product was administered on 09-Dec-2003. Dose regimen was 1 dose (intranasal). Concomitant Therapy: Concomitant medications were not reported. Event Details: On 10-Dec-2003, 1 day post-immunization, the patient experienced headache and was feeling tired. On 15-Dec-2003, he was tired and achy. No additional information was available at the time of this report.									U	12/09/2003	12/10/2003	1	UNK	PVT	OTH	UNK	UNK	UNK		HQWYE7350	1						1	Fatigue; Headache; Pain	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216127	02/05/2004	NC	7.0	7		M	12/19/2003	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a 7-year-old male patient who experienced nasal congestion, sore throat, fever and nausea. At 7 years of age, the patient received the first dose on 12-Dec-2003. Medical History: Relevant medical history was not provided. Product Details: Indication for Flumist (2003-2004 Formula) was immunisation. Product was administered on 12-Dec-2003. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Concomitant medications were not reported. Event Details: On 14-Dec-2003, 2 days post-immunization, the child developed nasal congestion and a sore throat. On 16-Dec-2003 he experienced a fever and nausea. Phenergan (promethazine hydrochloride) (manufacturer unknown) was prescribed for the nausea. No additional information was available at the time of this report.									U	12/12/2003	12/16/2003	4	UNK	OTH	OTH	UNK	UNK	UNK		HQWYE7377	1						1	Nasal congestion; Nausea; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500032P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216128	02/05/2004	NC				M	12/19/2003	Information regarding Flumist was received from a healthcare professional regarding a male child who experienced itchy eyes about five minutes after receiving Flumist. The pt received a dose on an unspecified date. The pt experienced itchy eyes about 5 minutes after receiving Flumist. The reporter indicated that the pt's mother also experienced the same event. The reporter stated that she doesn't know if the child just itched his eyes because he saw his mom itch her eyes. No additional info was available at the time of this report.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQWYE753718DEC03	1						1	Eye disorder; Pruritus	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216129	02/05/2004	NJ	42.0			F	12/19/2003	Follow-up info received from the pt's physician provided the following: concomitant vaccine; illnesses at time of vaccination; relevant diagnostic tests/ lab data; and medical history. A health care professional reported that a 42 year old female pt received a dose of Flumist on 10/27/03 and experienced a drug interaction and menstrual spotting. The pt experienced a drug interaction and menstrual spotting. On 10/29/03, the pt indicated she started menstrual spotting and got her period on 11/3/03. This event occurred one week early. The pt stated that she is currently continuing the Nordette-21 and should not have her period. She indicated that this has never happened before. No additional info was available at the time of this report.									U	10/27/2003	10/29/2003	2	NONE	PVT	OTH	Nordette-21	NONE	UNK		HQWYE768405NOV03	1						1	Drug interaction; Metrorrhagia	FLUN3~MEDIMMUNE VACCINES, INC.~500012P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216130	02/05/2004	NC	44.0	44		M	12/11/2003	A health care professional reported that a 44 year old male pt received a dose of Flumist on 10/16/03 and experienced muscle aches, fever and chest congestion. The pt experienced muscle aches (myagia) on 10/17/03, fever on 10/21/03 and chest congestion on 10/26/03. The pt was treated with erythromycin, prednisone and Mucinex. The pt has recovered. No additional info was available at the time of this report.									Y	10/16/2003	10/21/2003	5	UNK	OTH	OTH	UNK	UNK	Bronchopneumonia		HQWYE804606NOV03	1						1	Myalgia; Pulmonary congestion; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500015P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216131	02/05/2004	NC	30.0	30		F	12/16/2003	Information regarding Flumist was received from a healthcare professional regarding a 30 year old female pt who experienced muscle aches, nasal burning, nasal tingling, nasal congestion and nasal bleeding. At 30 years of age, the pt received the first dose on 10/28/03. The pt experienced muscle aches, nasal burning, nasal tingling, nasal congestion and nasal bleeding on 10/28/03. At the date of the report, muscle aches and nasal bleeding has resolved; however, nasal burning, nasal tingling and nasal congestion had not resolved. The pt was being treated with Sudafed and Nasonex. No additional info was available at the time of this report.									U	10/28/2003	10/28/2003	0	UNK	OTH	OTH	UNK	UNK	Smoker; ear infection		HQWYE804706NOV03	1						1	Epistaxis; Myalgia; Nasal congestion; Nasal discomfort; Paraesthesia	FLUN3~MEDIMMUNE VACCINES, INC.~5000015P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216132	02/05/2004	CA	48.0			M	12/16/2003	Information regarding Flumist was received from a healthcare professional regarding a 48 year old male tp who experienced nasal congestion and drainage down his throat. The pt received a dose on 11/6/03. The pt experienced nasal congestion, and drainage down his throat immediately after receipt of the vaccine on 11/6/03. He then blew his nose to relieve the congestion in his left nostril. The reporter indicated that the pt did not have a cold prior to administration. No additional  info was available at the time of this report.									U	11/06/2003	11/06/2003	0	UNK	OTH	OTH	UNK	UNK	UNK		HQWYE854307NOV03	1						1	Nasal congestion	FLUN3~MEDIMMUNE VACCINES, INC.~500015P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216133	02/05/2004	IL				F	10/06/2003	Information regarding Flumist was received from a company representative regarding a female pt (who is the nurse) who experienced teary eyes, scratchy throat and bronchial spasms. Thhe pt, is also the nurse, who sprayed the Flumist into the air. She experienced teary eyes, scratchy throat and bronchial spasms. A bronchial neublizer treatment was administered and she recovered. The reporter indicated that ten other people were in the room and they are all fine. No additional info was available at the time of this report.									Y		09/23/2003		UNK	OTH	OTH	UNK	UNK	UNK		HQWYE859624SEP03	1						1	Bronchospasm; Dry throat; Lacrimation increased	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216134	02/05/2004					F	12/23/2003	A nurse reported via a company representative that upon administering a dose of Flumist to a pt she experienced lightheadedness, headache, and skin peeling on her hand. A nurse experienced lightheadedness, headache, and skin peeling on her hand on 11/7/03 upon administering a dose of Flumist to a pt (accidental exposure). The nurse has recovered.									Y		11/07/2003		UNK	OTH	OTH	UNK	UNK	UNK		HQWYE927711NOV03	1						1	Dizziness; Headache; Medication error; Skin exfoliation	FLUN3~MEDIMMUNE VACCINES, INC.~5000004P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216135	02/05/2004	GA				F	12/19/2003	A health care professional reported via a company representative that a female pt received a dose of Flumist on an unspecified date and experienced burning and discomfort to her nasal passage. The pt experienced burning and discomfort to nasal passage. The pt has recovered. No additional info was available at the time of this report.									Y				UNK	PVT	OTH	UNK	UNK	UNK		HQWYE927811NOV03	1						1	Nasal discomfort	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216136	02/05/2004	NE	40.0	40		F	12/15/2003	Information regarding Flumist was received from a consumer herself, a 40 year old female, who experienced gagging, eyes watered and awful taste. At 40 years of age, she received a dose on 11/7/03. The pt experienced gagging (retching), eyes watered (lacrimation inc) and awful taste on 11/7/03. No additional info was available at the time of this report.									Y	11/07/2003	11/07/2003	0	UNK	OTH	PVT	Alavert, Flonase	UNK	Seasonal allergy		HQWYE944711NOV03	1						1	Dysgeusia; Lacrimation increased; Retching	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216137	02/05/2004	TX	32.0	32		F	12/19/2003	Information regarding Flumist was received from a 32 year old female who developed nose bleed, runny nose, sinus pressure, wheezing, nasal swelling, difficulty breathing and walking pnuemonia. At 32 years of age, the pt received a dose on 10/21/03. Immediately following immunization, both of her nostrils swelled then closed completely. Twenty minutes post immunization, she developed bleeding from both nostrils which continued for 2 days. She also experienced sinus pressure, wheezing, and a runny nose with clear discharge. She was treated with Sudafed, Nyquil Cold and Flu, and amoxicillin but indicated that none of these medications relieved the sinus pressure, swelling, or runny nose. On 11/9/03, she reported her lungs filled up with fluid and she couldn't breathe. On 11/15/03, she was seen by the physician and diagnosed with walking pneumonia. She was treated with a steroid taper and her symptoms cleared almost immediately. No additional info was available at the time of this report.				Y					U	10/21/2003	11/15/2003	25	UNK	OTH	PVT	Triphasil-21	UNK	UNK		HQWYE951111NOV03	1						1	Dyspnoea; Epistaxis; Oedema; Pneumonia; Rhinorrhoea; Sensation of pressure; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500014P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0216138	02/05/2004	NE	10.0	10		M	12/15/2003	Information regarding Flumist nasal solution was received from a consumer regarding her 10 year old son who experienced gagging, eyes watered, awful taste, runny nose, stuffy nose, coughing and feeling tired. At 10 years of age, the patient received a dose on 11/7/03. The patient's concurrent illness includes seasonal allergy. Indication for Flumist was immunization. Product was administered on 11/7/03. Dose regimen was 0.5mL 1 time per day (IN). Concomitant therapy included Claritin. The patient experienced gagging, eyes watered, and awful taste on 11/7/03. He developed a runny nose, stuffy nose, coughing, and feeling tired on 11/8/03. At the date of this report, his runny nose persisted. No additional information was available at the time of this report.									U	11/07/2003	11/07/2003	0	UNK	OTH	PVT	Claritin	UNK	Seasonal allergy		HQWYE956611NOV03	1						1	Cough; Dysgeusia; Fatigue; Lacrimation increased; Nasal congestion; Retching; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216139	02/05/2004		7.0	7		M	12/15/2003	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 7-year-old male patient who experienced fever and cold symptoms. At 7 years of age, the patient received a dose on 06-Nov-2003. Medical History: The patient had no relevant medical history. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 06-Nov-2003. Dose regimen was 1 dose 1 times per day (intranasal). Concomitant Therapy: Concomitant medications were not reported. Event Details: The patient developed the cold symptoms (nasopharyngitis) of a runny nose and fever (pyrexia) and on 08-Nov-2003. The patient's mother indicated that as of 11-Nov-2003, the symptoms were improving. Related Case(s): The patient's brother developed a runny nose on 11-Nov-2003, after being in close contact with the patient post-vaccination. The infant had also received an influenza virus vaccine injection (manufacturer unknown) on 06-Nov-2003 (see MCN HQWYE019612NOV03). No additional information was available at the date of this report.									U	11/06/2003	11/08/2003	2	UNK	OTH	OTH	UNK	UNK	UNK	~Influenza (Seasonal) (no brand name)~~0.00~In Sibling	HQWYE0195	1						1	Pharyngitis; Pyrexia; Rhinitis	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216140	02/05/2004	CA				F	01/08/2004	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a female patient who received a dose on an unspecified date. The patient received a dose in 2003. Medical History: Relevant medical history was not provided. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered in 2003. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Concomitant medications were not reported. Event Details: It was reported that Flumist ran down the patient's throat and she coughed (cough). No additional information was available at the time of this report.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQYE3003	1						1	Cough	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216141	02/05/2004	MI	5.0	5		M	12/11/2003	Information regarding Flu Mist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a parent regarding her 5-year-old son who experienced vomiting. At 5 years of age, the patient received a dose on 25-Nov-2003. Medical History: Relevant medical history was not provided. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 25-Nov-2003. Concomitant Therapy: Concomitant medications were not reported. Event Details: The patient experienced vomiting (vomiting) on 26-Nov-2003 at 2:00 AM. At the date of the report, the mother indicated that she had not notified the physician. No additional information was available at the time of this report.									U	11/25/2003	11/26/2003	1	UNK	OTH	OTH	UNK	UNK	UNK		HQWYE3573	1						1	Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216142	02/05/2004	UT	44.0	44		F	12/17/2003	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 44-year-old female patient who experienced low fever, head cold, tiredness, weakness, chills and sore throat. The patient received a dose on 19-Nov-2003. Medical History: Relevant medical history was not provided. Product Details: Indication for Flumist (2003-2004 Formula) was immunisation. Product was administered on 19-Nov-2003. Dose regimen was 1 dose 1 time per day (intranasal). Concomitant Therapy: Concomitant medications were not reported. Event Details: On 21-Nov-2003, the patient developed a low fever (pyrexia), head cold (nasopharyngitis), tiredness (fatigue), weakness (asthenia), chills (rigors), and sore throat (pharyngolaryngeal pain). During the morning of 25-Nov-2003, the patient stated that she did not feel feverish however as the day progressed, she felt feverish. On 26-Nov-2003, the reporter indicated that she did not feel feverish but the tiredness and a bit of a head cold persisted. She recovered. No additional information was available at the time of this report.  Additional information received on 05-JAN-2004 and 06-JAN-2004 from the reporter indicated that the patient did not seek medical treatment for the reported adverse events. Information regarding FLUMIST (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a consumer regarding a 44-year-old female patient who experienced low fever, head cold, tiredness, weakness, chills and sore throat. The patient received a dose on 19-Nov-2003. On 21-NOV-2003, the patient developed a low fever, head cold, tiredness, weakness, chills, and sore throat. During the morning of 25-NOV-2003, the patient stated that she did not feel feverish however as the day progressed, she felt feverish. On 26-NOV-2003, the reporter indicated that she did not feel feverish but the tiredness and a bit of a head cold persisted. The reporter indicated that she recovered from the fever, chills, and sore throat.									Y	11/19/2003	11/21/2003	2	Unknown	OTH	OTH	Unknown	Unknown	Relevant medical history was not provided.		HQWYE380903DEC03	1						1	Asthenia; Chills; Fatigue; Nasopharyngitis; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500013P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216143	02/05/2004	IL	23.0	23		F	12/11/2003	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a 23-year-old female patient when experienced a fever of 104 deg. F., chills, headache, stuffy nose and achy muscles. At 23 years of age, the patient received a dose on 29-Nov-2003. Medical History: Relevant medical history was not provided. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 29-Nov-2003. Dose regimen was 1 dose (intranasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: The patient experienced a fever of 104 deg. F (pyrexia), chills (rigors), headache (headache), stuffy nose (nasal congestion) and achy muscles (myalgia) on 30-Nov-2003. She was treated with Advil (ibuprofen). As of 02-Dec-2003, her symptoms persisted. No additional information was available at the date of this report.  Follow-up information received from the patient's physician provided duration of illness, recovery status, medical history (non known medication allergies), and laboratory tests performed (none). Information regarding FLUMIST (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a healthcare professional regarding a 23-year-old female patient who experienced a fever of 104 deg. F., chills, headache, stuffy nose and achy muscles. At 23 years of age, the patient received a dose on 29-Nov-2003. On 30-Nov-2003, the patient developed a fever of 104 deg. F., chills, headache, stuffy nose and achy muscles. She was treated with ADVIL. The reporter indicated that the patient was ill for four days total. She completely recovered.									Y	11/29/2003	11/30/2003	1	No tests performed	OTH	PVT	Patient was not taking concomitant therapy.	Unknown	The patient had no known medication allergies.		HQWYE396003DEC03	1						1	Chills; Headache; Myalgia; Nasal congestion; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216144	02/05/2004	WI	9.0	9		M	12/19/2003	Information regarding FluMist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding her 9-year-old male child who received a dose on November 26, 2003. Medical History: Relevant medical history was not provided. Product Details: Indication for FluMist (2003-2004 Formula) was immunization. Product was administered on November 26, 2003. Dose regimen was 0.5 mL 1 time per day (intranasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: The consumer reported that her son received a dose of FluMist on November 26, 2003 and developed the flu on November 30, 2003. Symptoms included: cough, fever over 100 degrees F., and body aches. He was treated with ibuprofen. Symptoms persisted on the day the report was received. No additional information was available at the time of this report.									N	11/26/2003	11/30/2003	4	UNK	PVT	PVT	NONE	UNK	UNK		HQWYE461708DEC03	1						1	Cough; Drug ineffective; Influenza; Pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216145	02/05/2004	IA	44.0			F	12/16/2003	Follow-up information received from pt's physician provided the following: adverse event information including symptoms, onset and recovery status; pt's gender and date of birth; concomitant medications (none); concomitant vaccines (none); illnesses at time of vaccination (none); and medical history (negative).  A health care professional reported that a 44 year old female pt received a dose of Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on an unspecified date in 10/03 and experienced flu-like symptoms, sore throat, nasal congestion, muscle aches, low-grade fever and chills.  The pt had no relevant medical history.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on an unspecified date in 10/03.  Dose regimen was 1 dose 1 time per day (IN).  The pt was not taking any concomitant medications.  Within 24 hours of vaccination, the pt experienced flu-like symptoms, sore throat, nasal congestion, muscle aches, low-grade fever, and chills.  The symptoms lasted for three days. The pt has recovered.  See related case(s): HQWYE626029OCT03 (adverse event, non-expedited).									Y				UNK	PVT	OTH	NONE	NONE	UNK		HQWYE468923OCT03	1						1	Chills; Influenza like illness; Myalgia; Nasal congestion; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216146	02/05/2004	IL	6.0			M	12/18/2003	Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a 6 year old male pt who received a dose on 12/03/03.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/03/03.  Dose regimen was 0.5mL 1 time per day (IN).  Concomitant medications were not reported.  It was reported by a pharmacist, that a 6 year old male, developed a fever of 101.3 deg F.  Symptoms occurred on 12/05, two days after receiving Flumist.  Reporter indicated there was no causal relationship between Flumist and fever.  No additional information was available at the time of this report. Follow-up information received from the physician's office on 05 Jan-2004 stated that, This was not a reaction and no further work up was done.									U	12/03/2003	12/05/2003	2	UNK	OTH	OTH	UNK	UNK	UNK		HQWYE548511DEC03	1						1	Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216147	02/05/2004	TN	10.0	10		F	12/16/2003	Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 10 year old female pt who experienced extreme tiredness.  At 10 years of age, the pt received a dose on 12/04/03.  The pt's concurrent illness includes ear infection.  The pt had a previous history of ear infections treated with Lorabid.  She was diagnosed with an ear infection the day she received Flumist.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/4/03.  Dose regimen was 1 dose (IN).  Concomitant therapy included Lorabid.  The pt experienced extreme tiredness on 12/05/03.  The mother reported that her daughter was so tired she slept until one o'clock in the afternoon.  As of 12/50/03, the tiredness had not resolved.  No additional information was available at the date of this report.									N	12/04/2003	12/05/2003	1	UNK	PVT	PVT	Lorabid;	UNK	Ear infection;		HQWYE552511DEC03	1						1	Fatigue	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216148	02/05/2004	TN	41.0	41		F	12/16/2003	Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) who received from a consumer regarding a 41 year old female pt who experienced nasal congestion.  At 41 years of age, the pt received a dose on 12/04/03.  The pt had no relevant medical history.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/04/03.  Dose regimen was 1 dose (IN).  Pt was not taking concomitant therapy.  The pt experienced nasal congestion (nasal congestion) on 12/05/03.  As of that date, the event had not resolved.  No additional information was available at the date of this report.									N	12/04/2003	12/05/2003	1	UNK	PVT	PVT	NONE	UNK	UNK		HQWYE554711DEC03	1						1	Nasal congestion	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216149	02/05/2004	VA	8.0	8		F	12/19/2003	A consumer reported that an 8 year old female pt received a dose of Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on 11/28/03.  The pt had no relevant medical history.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 11/28/03.  Dose regimen was 1 dose 1 time per day (IN).  No concomitant medications or vaccines were administered.  On 11/30/03, the pt developed nasal congestion and a minor sore throat due to drainage.  On 12/05/03, the pt developed green nasal discharge.  The reporter indicated that the pt's health care professional has been notified.  The pt has not recovered.  No additional information was available at the time of this report. Additional information received on 09-Jan-2004 from the family nurse practictioner provided additional adverse event informaton. On the same day, she was examined by a family nurse practicioner. Upon physical examination temperature was 97.8 deg. F.; blood pressure 102/60, the ears looked fine, there was mild to moderate nasal congestion, scant postnasal drip, no cervical lymphadenopathy; clear bilateral breath sounds, and unlabored breathing. The nurse stated the patient had very little in the way of a nonproductive cough and there had been no fever. The patient denied headache. A diagnosis of viral upper respiratory infection was made. Treatment included pusing fluids; a trial of Robitussin (guaifenesin/dextromethorphan) was suggested.									N	11/28/2003	11/30/2003	2	UNK	PVT	OTH	NONE	UNK	UNK		HQWYE554811DEC03	1						1	Cough; Nasal congestion; Pharyngolaryngeal pain; Postnasal drip; Rhinorrhoea; Upper respiratory tract infection; Viral infection	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216150	02/05/2004	VA	6.0	6		M	12/16/2003	A physician reported that his 6 year old son received a dose of Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on 12/02/03, and 5 days later, his son developed flu-like symptoms.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/02/03.  Dose regimen was 1 dose.  Pt was not taking concomitant therapy.  On 12/07/03, 5 days post-immunization, the child developed flu-like symptoms characterized by cough, stuffy nose and unconfirmed fever.  The physician reported that the child's 8 year old brother received Flumist on the same date and has no flu symptoms.  In 12/03, a nasal swab was positive for influenza.  No additional information was available at the time of this report.									U	12/02/2003	12/07/2003	5	12/03: Nasal swab positive for influenza.	OTH	PVT					HQWYE572412DEC03	1						1	Cough; Influenza like illness; Laboratory test abnormal; Nasal congestion; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500015P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216151	02/05/2004	NJ				F	12/16/2003	Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a physician regarding his daughter who developed flu-like symptoms.  The pt received a dose in 2003.  Relevant medical history was not provided.  The pt received a dose on an unspecified date in 2003.  Indication for Flumist (2003-2004 formula) was immunization.  Dose regimen was 1 dose 1 time per day (IN).  Concomitant medications were not reported.  The pt experienced flu-like symptoms (influenza like illness) and was flat on her back for three days.  She recovered.  No additional information was available at the time of this report. Additional information was received on 26-Jan-2004 from the physician which provided patient demographics, medical history, vaccine administration date, product lot number, adverse event onset day and additional adverse event information.  On Nov-2003, two days post- immunization, the patient experienced flu-like symptoms (influenza like illness) and was flat on her back for five days. She recovered.									Y	11/27/2003	11/29/2003	2	UNK	OTH	OTH	UNK	UNK	The patient had no relevant medical history. The reporter indicated that the patient was not ill prior to the administration of Flumist.		HQWYE586912DEC03	1						1	Influenza like illness	FLUN3~MEDIMMUNE VACCINES, INC.~50013P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216152	02/05/2004	LA	6.0	6		M	12/18/2003	A mother reported that her 6 year old son received a dose of Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on 12/09/03.  The pt's concurrent illness includes unspecified allergies.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/09/03.  Dose regimen was 1 dose 1 time per day (IN).  Concomitant therapy included Zyrtec and Nasonex.  Concomitant vaccines were not administered.  On 12/10/03, the child developed a runny nose and cough.  He was treated with Robitussin CF.  The mother reported that the child was in the waiting room for 45 minutes with a bunch of sick kids immediately prior to immunization.  As of 12/11/03, the cough and runny nose persisted.  No additional information was available at the time of this report.									N	12/09/2003	12/10/2003	1	UNK	PVT	PVT	Nasonex; Zyrtec;	UNK	Hypersensitivity;		HQWYE626015DEC03	1						1	Cough; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216153	02/05/2004	TX	6.0	6		F	12/16/2003	Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a 6 year old female pt who experienced nasal congestion, headache and fever.  One week prior to the administration of Flumist, the pt developed wheezing.  Treatment consisted of an unspecified dose of oral steroids.  On 12/08/03, at 6 years of age, the pt received the first dose of Flumist (2003-2004 formula).  Indication for flumist (2003-2004 formula) was immunization.  Dose regimen was 1 dose 1 time per day (IN).  The pt was not taking concomitant therapy.  No other vaccines were administered.  On 12/09/03, the pt experienced a headache.  On 12/10/03, the headache persisted and the pt developed nasal congestion and fever ranging from 102 deg F to 103 deg F.  As of the date of this report, the event has not been resolved.  No additional information was available at the time of this report.				Y					N	12/08/2003	12/10/2003	2	UNK	PVT	PVT	NONE	UNK	Wheezing;		HQWYE630915DEC03	1						1	Headache; Nasal congestion; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0216154	02/05/2004	NJ	35.0	35		F	12/16/2003	Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 35 year old female pt who experienced low grade fever and cold like symptoms.  At 35 years of age, the pt received a dose on 12/06/03.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 formula) was immunization. Product was administered on 12/06/03.  Dose regimen was 1 dose (IN).  Concomitant therapy included Sudafed.  The pt experienced low grade fever on 12/09/03 and cold like symptoms on 12/10/03.  No additional information was available at the time of this report.									U	12/06/2003	12/09/2003	3	UNK	PVT	OTH	Sudafed;	NONE	UNK		HQWYE640016DEC03	1						1	Malaise; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216155	02/05/2004	MS	10.0	10		F	12/19/2003	Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her a 10 year old daughter who experienced fever (101 deg F), felt achy and runny nose.  At 10 years of age, the pt received a dose on 12/08/03.  The pt had no relevant medical history.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/08/03.  Dose regimen was 1 dose 1 time per day (IN).  Pt was not taking concomitant therapy.  On 12/10/03, the pt woke up with a fever (101 deg F).  She also felt achy and had a runny nose all day.  She was treated with Tamiflu, which she took one dose of, and Vantin.  The mother reported that as of 12/11/03, her daughter felt better, and her temperature was 99 deg F.  No additional information was available at the date of this report.									U	12/08/2003	12/10/2003	2	UNK	PVT	PVT	NONE	UNK	UNK		HQWYE650316DEC03	1						1	Pain; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216156	02/05/2004	CA	12.0			F	12/17/2003	Information regarding Flumist nasal solution was received from a healthcare professional regarding a 12 year old female patient who experienced high fever. At 12 years of age, the patient received vaccine. Relevant medical history was not provided. Indication for Flumist was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. The patient developed high fever within 24 hours of immunization. No additional information was available at the time of this report.									U				UNK	PVT	OTH	UNK	UNK	UNK		HQWYE655716DEC03	1						1	Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216157	02/05/2004	CA				F	12/19/2003	Information regarding Flumist nasal solution was received from a consumer regarding a female patient who experienced very sore throat, feeling tired, weak and yellow nasal discharge. The patient received a dose on 12/9/03. Relevant medical history was not provided. Indication for Flumist was immunization. Product was administered on 12/9/03. dose regimen was 0.5mL (IN). Concomitant medications were not reported. On 12/10/03, 1 day post immunization, the patient experienced a very sore throat, feeling tired, and weak. On 12/11/03, 2 days after Flumist, she had a yellow nasal discharge. The reporter declined to provide additional information and declined to grant permission for follow up investigation.									U	12/09/2003	12/10/2003	1	UNK	OTH	OTH	UNK	UNK	UNK		HQWYE671817DEC03	1						1	Asthenia; Fatigue; Pharyngolaryngeal pain; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216158	02/05/2004	MI	6.0	6		F		Follow up information was received from the reporter on 11/24/03 providing the patient's name, date of birth and county of vaccine administration. Information regarding Flumist nasal solution was received from a healthcare professional regarding a 6 year old female who received the vaccine on 10/28/03. Within 15 hours post immunization, the patient developed a fever of 102.5 degrees F and a croup-like cough. Relevant medical history was not provided. Indication for Flumist was immunization. Product was administered on 10/28/03. Dose regimen was 1 dose 1 time per day (nasal). Concomitant medications were not reported. Within 15 hours post immunization, the girl developed a fever of 102.5 degrees F and a croup like cough.									U	10/28/2003	10/29/2003	1	UNK	OTH	OTH	UNK	UNK	UNK		HQWYE673131OCT03	1						1	Cough; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216159	02/05/2004	GA	6.0	6		M	12/19/2003	Information regarding Flumist nasal solution was received from a mother, regarding her 6 year old who was feeling irritable. At 6 years of age, the patient received a dose on 12/10/03. Relevant medical history was not provided. Indication for Flumist was immunization. Product was administered on 12/10/03. Dose regimen was 0.5mL (IN). Concomitant medications were not reported. On 12/12/03, 2 days post immunization, the child was feeling irritable by lunchtime. No additional information was available at the time of this reports.									U	12/10/2003	12/12/2003	2	UNK	PVT	OTH	UNK	UNK	UNK		HQWYE677717DEC03	1						1	Irritability	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216160	02/05/2004	PA	5.0	5		M	12/19/2003	Information regarding Flumist nasal solution was received from a consumer regarding a 5 year old male patient who experienced high fever of 105 degrees F, throwing up, stomach hurting, stuffiness and cough. At 5 years of age, the patient received a dose on 12/15/03. The patient's concurrent illness includes cough. The patient had respiratory symptoms with cough prior to Flumist administration; however, the mother thought the acute phase had passed. The patient had two days of oral steroid therapy four days prior to Flumist administration. Indication for Flumist was immunization. Product was administered on 12/15/03. Dose regimen was 1 (IN). Patient was not taking concomitant therapy. The patient experienced high fever of 105 degrees F, throwing up, stomach hurting, stuffiness, and cough on 12/15/03. The patient was treated with Tylenol every four hours. As of 12/16/03, the fever of 105 degrees F persisted. No additional information was available at the date of this report.									U	12/15/2003	12/15/2003	0	UNK	PVT	OTH	NONE	UNK	Cough		HQWYE686717DEC03	1						1	Abdominal pain; Cough; Nasal congestion; Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216161	02/05/2004	AR	11.0	11		M	12/23/2003	A nurse reported that an 11 year old male patient received a dose of Flumist nasal solution on 12/11/2003. The patient has no significant medical history. Indication for Flumist was immunization. Product was administered on 12/11/03. Dose regimen was 1 dose 1 time per day. There were no concomitant vaccines or medications. On 12/12/03, one day post immunization, the patient developed fever to 102.3 degrees F, nasal congestion and cough. At the date this event was reported, the cough and nasal congestion persisted and the patient's fever was recorded at 98.5 degrees F. Treatment information was not provided. No additional information was available at the time of this report.									U	12/11/2003	12/12/2003	1		PVT	OTH	NONE	UNK	UNK		HQWYE687217DEC03	1						1	Cough; Nasal congestion; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500018P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216162	02/05/2004	LA	7.0	7		F	12/19/2003	Information regarding Flumist nasal solution was received from a consumer regarding 7 year old female patient who experienced stuffy nose. At 7 years of age, the patient received a dose on 12/15/03. Patient had no relevant medical history. Indication for Flumist was immunization. Product was administered on 12/15/03. Dose regimen was 1 dose (IN). Patient was not taking concomitant therapy. The patient experienced stuffy nose on 12/16/03. No additional information was available at the time of this report.									U	12/15/2003	12/16/2003	1	UNK	PVT	PVT	NONE	NONE	UNK		HQWYE688417DEC03	1						1	Nasal congestion	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216163	02/05/2004	PA	49.0	49		F	12/18/2003	Information regarding Flumist nasal solution was received from a healthcare professional regarding a 49 year old female patient who experienced headache and general body aches. At 49 years of age, the patient received a dose on 12/8/03. The patient's concurrent illness includes hypothyroidism. The patient has no known medication allergies. Indication for Flumist was immunization. Product was administered on 12/8/03. Dose regimen was 1 dose (IN). Concomitant therapy included Synthroid. THe patient experienced headache and body aches on 12/10/03. She was treated with Advil Cold and Sinus and Duratuss. She recovered. No additional information was available at the date of this report.									Y	12/08/2003	12/10/2003	2	UNK	OTH	OTH	Synthroid	UNK	Hypothyroidism		HQWYE690717DEC03	1						1	Headache; Pain	FLUN3~MEDIMMUNE VACCINES, INC.~500004P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216164	02/05/2004	KY				F	12/18/2003	Information regarding Flumist nasal solution was received from a consumer regarding a female patient who experienced runny nose, dry cough, achy muscles, and low grade fever. The patient received the vaccine. The patient's concurrent illnesses include mild egg allergy and autoimmune thyroiditis. Indication for Flumist was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. The patient experienced runny nose immediately after vaccination. Four days post-immunization, she developed a dry, deep cough. Five days post-immunization, she experienced achy muscles. Six days post-immunization, she developed a low grade fever. The reporter indicated that she participated in a Flumist study in 1998 and had none of these side effects. No additional information was available at the time of this report.									U				UNK	OTH	OTH	UNK	UNK	Autoimmune thyroiditis; Food allergy		HQWYE691117DEC03	1						1	Cough; Hypersensitivity; Myalgia; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216165	02/05/2004	LA	37.0	37		M	12/18/2003	Information regarding Flumist nasal solution was received from a consumer regarding a 37 year old male patient who experienced a stuffed nose and sore throat. At 37 years of age, the patient received a dose on 12/15/03. The patient has no relevant medical history. Indication for Flumist was immunization. Product was administered on 12/15/03. Dose regimen was 1 dose (IN). Patient was not taking concomitant therapy. The patient experienced stuffed nose and sore throat on 12/16/03. No additional information was available at the date of this report.									U	12/15/2003	12/16/2003	1	UNK	PVT	PVT	NONE	UNK	UNK		HQWYE691917DEC03	1						1	Nasal congestion; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216166	02/05/2004	LA	11.0	11		F	12/19/2003	Information regarding Flumist nasal solution was received from the father of an 11 year old female who experienced stuffy nose and sore throat. At 11 years of age, the child received a dose on 12/15/03. The child had no relevant medical history. Indication for Flumist was immunization. Product was administered on 12/15/03. Dose regimen was 1 dose (IN). The child was not taking concomitant therapy. The child experienced stuffy nose and sore throat on 12/16/03. No additional information was available at the time of this report.									U	12/15/2003	12/16/2003	1	UNK	PVT	PVT	NONE	NONE	UNK		HQWYE692817DEC03	1						1	Nasal congestion; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216167	02/05/2004	NJ	33.0	33		F	12/19/2003	Information regarding Flumist nasal solution was received from a consumer regarding a 33 year old female patient who experienced cold like symptoms, runny nose, sore throat and feeling achy. At 33 years of age, the patient received a dose on 12/12/03. The patient had no relevant medical history. Indication for Flumist was immunization. Product was administered on 12/12/03. Dose regimen was 0.5mL (IN). Patient was not taking concomitant therapy. On 12/13/03, 1 day post immunization, the patient experienced cold like symptoms, characterized by a runny nose, sore throat and feeling achy. Her symptoms continued at the time of this report. No additional information was available at the time of this report.									N	12/12/2003	12/13/2003	1	UNK	PVT	PVT	NONE	NONE	UNK		HQWYE693117DEC03	1						1	Pain; Pharyngitis; Pharyngolaryngeal pain; Rhinitis; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216168	02/05/2004	PA	15.0	15		F	12/19/2003	Information regarding Flumist nasal solution was received from a consumer regarding a 15 year old female patient who experienced headache and body aches. At 15 years of age, the patient received a dose on 12/15/03. The patient has no relevant medical history. Indication for Flumist was immunization. Product was administered on 12/15/03. Dose regimen was 1 dose (IN). Patient was not taking concomitant therapy. The patient experienced headache and body aches on 12/15/03. The patient's sister developed headache and body aches following receipt of Flumist on 12/15/03, at 13 years of age. No additional information was available at the date of this report.									U	12/15/2003	12/15/2003	0	UNK	OTH	OTH	NONE	UNK	UNK	Headaches; Body aches~Influenza (Seasonal) (FluMist)~~13.00~In Patient	HQWYE697117DEC03	1						1	Headache; Pain	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216169	02/05/2004	VA	11.0	11		F	12/18/2003	Information regarding Flumist nasal solution was received from a health care professional regarding a 11 year old female patient who experienced fever of 101.9 degrees F, chills, vomiting, body aches, and sore throat. At 11 years of age, the patient received a dose on 12/12/03. Relevant medical history was not provided. Indication for Flumist was immunization. Product was administered on 12/12/03. Dose regimen was 1 dose (IN). Patient was not taking concomitant therapy. The patient experienced fever of 101.9 degrees F, chills, vomiting, body aches, and sore throat on 12/13/03. She was seen by a physician on 12/16/03 for these symptoms. No additional information was available at the date of this report.				Y					U	12/12/2003	12/13/2003	1	UNK	OTH	OTH	NONE	NONE	UNK		HQWYE698317DEC03	1						1	Chills; Pain; Pharyngolaryngeal pain; Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500033P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0216170	02/05/2004	LA	29.0	29		F	12/19/2003	Information regarding Flumist nasal solution was received from a consumer regarding his 29 year old wife who experienced diarrhea, sore throat and stuffy nose. At 29 years of age, she received a dose on 12/15/03. She had no relevant medical history. Indication for Flumist was immunization. Product was administered on 12/15/03. Dose regimen was 1 dose (IN). She was not taking concomitant therapy. On 12/16/03, she experienced diarrhea, sore throat, and stuffy nose. No additional information was available at the time of this report.									U	12/15/2003	12/16/2003	1	UNK	PVT	PVT	NONE	NONE	UNK		HQWYE698617DEC03	1						1	Diarrhoea; Nasal congestion; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216171	02/05/2004	VA	10.0	10		M	12/19/2003	Information regarding Flumist nasal solution was received from a consumer regarding a 10 year old male patient who experienced headache, runny nose, fever and sore throat. At 10 years of age, the patient received a dose on 12/10/2003. Relevant medical history was not reported. Indication for Flumist was immunization. Product was administered on 12/10/03. Dose regimen was 1 dose 1 time per day (IN). Concomitant medications were not reported. On 12/13/03, the patient experienced headache, runny nose, and fever which ranged to 102 degrees F axillary. A sore throat developed on 12/15/03. He was treated with unspecified over the counter medications. No additional information was available at the time of this report.									U	12/10/2003	12/13/2003	3	UNK	OTH	OTH	UNK	UNK	UNK		HQWYE719518DEC03	1						1	Headache; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500013P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216172	02/05/2004	AL	7.0	7		F	12/19/2003	A health care professional reported that a 7 year old female patient received a dose of Flumist nasal solution on 12/12/03. The reporter indicated that the patient is a well child. Indication for Flumist was immunization. Product was administered on 12/12/03. Dose regimen was 1 dose 1 time per day (IN). Patient was not taking concomitant therapy. On 12/12/03, the patient developed cough and a runny nose. On 12/14/03, the patient developed a fever of 101 degrees F to 102 degrees F. She was treated with Tylenol and Motrin. No additional information was available at the time of this report. Additional information was received on 13-Jan-2004 from the reporter which provided recovery status. On 13-Jan-2004, he recovered.									U	12/12/2003	12/14/2003	2	UNK	OTH	OTH	NONE	UNK	The reported indicated that the patient is a well child.		HQWYE727318DEC03	1						1	Cough; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216173	02/05/2004	AL	49.0	49		F	12/19/2003	Information regarding Flumist nasal solution was received from a 49 year old female consumer who experienced scratchy throat and runny nose. At 49 years of age, the patient received a dose on 12/11/03. The patient had no relevant medical history. Indication for Flumist was immunization. Product was administered on 12/11/03. Dose regimen was 1 dose (IN). Concomitant therapy included Celebrex, Wellbutrin, and Evista. On 12/14/03, 3 days post-immunization, the patient experienced a scratchy throat and runny nose. On 12/15/03, her symptoms were worse. No additional information was available at the time of this report. Follow up informatiion received from the physician revealed that the patient did not report the adverse event to the physician.									N	12/11/2003	12/14/2003	3	UNK	PVT	PVT	Celebrex; Evista; Wellbutrin	NONE	UNK		HQWYE727618DEC03	1						1	Pharyngolaryngeal pain; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216174	02/05/2004					F	12/19/2003	Information regarding Flumist nasal solution was received from a consumer regarding a female patient who experienced sore throat. The patient received a dose on 12/13/03. Relevant medical history was not provided. Indication for Flumist was immunization. Product was administered on 12/13/3. Dose regimen was 1 dose (IN). Concomitant medications were not reported. The patient experienced sore throat on 12/13/03. The reporter declined to provide additional information and declined to grant permission for follow up investigation.									U	12/13/2003	12/13/2003	0	UNK	OTH	OTH	UNK	UNK	UNK		HQWYE731618DEC03	1						1	Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216175	02/05/2004	RI	5.0	5		M	12/19/2003	Information regarding Flumist nasal solution was received from a mother regarding her 5 year old son who experienced nasal congestion and cough. At 5 years of age, the patient received a dose on 12/12/03. The patient had no relevant medical history. Indication for Flumist was immunization. Product was administered on 12/12/03. Dose regimen was 1 dose (IN). Patient was not taking concomitant therapy. On 12/13/03, 1 day post immunization, the child experienced nasal congestion and cough. He was treated with Children's Motrin Suspension and Triaminic Cough Syrup; however all symptoms were unresolved at the time of this report. No additional information was available at the time of this report. Follow-up information receveived rom the physician confirmed the child had no previous doses of Flumist, no other vaccines within four weeks of receiving Flumist, and no history of adverse events following prior vaccinations.  It was not reported if the patient had recovered.									N	12/12/2003	12/13/2003	1	UNK	PVT	PVT	NONE	NONE	UNK		HQWYE731818DEC03	1						1	Cough; Nasal congestion	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216176	02/05/2004		22.0	22		M	12/19/2003	A health care professional reported that a 22 year old male patient received a dose of Flumist nasal solution on 12/10/03. Relevant medical history was not provided. Indication for Flumist was immunization. Product was administered on 12/10/03. Dose regimen was 1 dose 1 time per day. Patient was not taking concomitant therapy. Three days after receiving Flumist, a nasal swab test was performed; the results were positive. On 12/10/03 the patient reported that he was experiencing a slight scratchy throat. On 12/13/03, the patient developed fever, muscle aches, sore throat, and nasal congestion. A diagnosis of influenza was made. No additional information was available at the time of this report. Additional information received on 26-Jan-2004 provided no new safety information.									U	12/10/2003	12/13/2003	3	Nasal swab was positive for the flu three days after receiving Flumist.	OTH	OTH	NONE	Slight scratchy throat	UNK		HQWYE731918DEC03	1						1	Drug ineffective; Influenza; Laboratory test abnormal; Myalgia; Nasal congestion; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216177	02/05/2004	PA	13.0	13		F	12/19/2003	Information regarding Flumist nasal solution was received from a consumer regarding a 13 year old female patient who experienced a headache and body aches. At 13 years of age, the patient received a dose on 12/15/03. The patient had no relevant medical history. Indication for Flumost was immunization. Product was administered on 12/15/03. Dose regimen was one dose (IN). Patient was not taking concomitant therapy. The patient experienced headache and body aches on 12/15/03. The patient's sister developed a headache and body aches following receipt of Flumist on 12/15/03, at 15 years of age. No additional information was available at the time of this report.									U	12/15/2003	12/15/2003	0	UNK	OTH	OTH	UNK	UNK	UNK	~Influenza (Seasonal) (FluMist)~~15.00~In Sibling	HQWYE734718DEC03	1						1	Headache; Pain	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216178	02/05/2004	PA	32.0	32		F	11/10/2003	Follow up information received from the nurse provided clarification of the date of vaccination administration and onset of symptoms, and treatment received. A nurse reported that a 32 year old female received a dose of Flumist nasal solution on 8/28/03. Medical history includes smoker, seasonal allergies and drug hypersensitivity to codeine and Biaxin. Indication for Flumist was immunization. Product was administered on 8/28/03. Dose regimen was 0.5mL. Concomitant medications were not reported. On 9/4/03, 1 week post immunization, the patient developed cough, sore throat, and burning in sinus. She was seen by her family physician, and treated for a sinus infection with amoxicillin.				Y					U	08/28/2003	09/04/2003	7	UNK	OTH	OTH	UNK	Sore throat; Sinus pain; Slight cough	Drug hypersensitivity; Smoker; Seasonal Allergy		HQWYE549808SEP03	1						1	Burning sensation mucosal; Cough; Infection; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~500005P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0216029	02/06/2004	CA	4.0	3		M	01/09/2004	Anaphylaxis post flu vaccine 10/15/03. The medical record received on 2/17/04 states anxiety, increased pulse, wheezing, and erythema. Medical record states vomiting, allergic reaction. msv			Y	Y					Y	10/15/2003	10/15/2003	0	NONE	PUB	PUB	NONE	NONE		Urticaria~Measles + Mumps + Rubella (MMR II)~0~1.00~In Patient		1						1	Anaphylactic reaction; Anxiety; Asthma; Erythema; Hypersensitivity; Tachycardia; Vomiting	FLU3~SANOFI PASTEUR~U1099AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0216031	02/06/2004	AK	8.0	8		F	01/22/2004	Developed immediate rash, itchiness 3 min after injection. Lungs clear with wheezing.  No respiratory distress, no oral swelling. Gave Zyrtec 10mg per mouth, instructed mom on symptoms to watch for that would required immediate attention. Rash noted on torso only.									Y	01/20/2004	01/20/2004	0	NONE	PVT	OTH	Prevacid; Vioxx;	NONE	ALLERGIES: Zithromax; Augmentin; Amoxil; Sulfa; Arthritis; GI irritation		AK200405	1						1	Pruritus; Rash; Wheezing	FLU3~SANOFI PASTEUR~U1111AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0216186	02/06/2004	AL	10.0	10		M	01/29/2004	Received phone call from school nurse. Child developed rash near nose after vaccine was given.  On next day rash was on side of face. He was in no distress and was at school.									Y	01/27/2004	01/27/2004	0	NONE	PUB	OTH	NONE	NONE	NONE		AL0403	1						1	Rash; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500101P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500101P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0216229	02/06/2004	CA	20.0	20		F	02/06/2004	Patient administered flu shot.  Kept under observation because of history of latex allergy.  After 10 minutes, concern of tightness in throat and was seen by doctor.				Y					Y	12/11/2003	12/11/2003	0		PUB	UNK			latex allergy			1						1	Throat tightness	FLU3~SANOFI PASTEUR~U1293AA~1~SC~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0216231	02/07/2004	MI	44.0	44		F	02/07/2004	On day of administration (12/10/03)in the afternoon states having hives on inside of elbow.  On 12/11 in the AM states legs, feet, stomach and back with hives.  12/13/03 states having a cough that hurts.  Denies dyspnea or tachycardia. Continues with pruritic hives.  Encouraged follow up call with physician.  States Benadryl did not help.  Physician prescribed Zyrtec and that relieved symptoms.  Developed pneumonia and was ill for 3 weeks after influenza vaccine.  Physician instructed her to not take the influenza vaccine in the future.									Y	12/10/2003	12/10/2003	0		PUB	PVT		NONE.	NKA.			1						1	Cough; Pneumonia; Urticaria	FLU3~EVANS VACCINES~766052~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0216232	02/07/2004	MI	2.0	2	.6	F	02/07/2004	First .25 ml influenza vaccine was given on 12/18/03.  Grandma states the client vomited but was ill one week prior.  After second .25ml dose the Mom reported vomiting, pale, heart racing, restless, and had bumps?? on face.									Y	01/20/2004	01/20/2004	0	none.	PUB	PVT		None during 1/20/04 vaccination	None			1						1	Heart rate increased; Pallor; Rash; Restlessness; Vomiting	FLU3~SANOFI PASTEUR~u1231BA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0216234	02/08/2004	SC	54.0	54		U	02/08/2004	Extreme sorness and pain upon raising arm and sleeping on right side continues to date, 2/8/2004.  Examined by a physician who felt there may be a hematoma in the muscle tissues.									U	10/22/2003	10/22/2003	0	None to date.	PUB	UNK				Sorness in left arm and shoulder~Influenza (Seasonal) (no brand name)~~10.20~In Patient		1						1	Haematoma; Joint range of motion decreased; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0213681	02/09/2004	UT	47.0	47		M	12/09/2003	Started itching 1/2 hour after immunization.  Hive-like rash on chest, back and lower extremities. Saw PA at MD office at 13:30 on 11/13.  Rash diagnosed as allergic reaction to flu vaccine. Given Rx (did not remember name of medication) to take 3 times a day for 2 days. Finished medication. Rash gone by 11/14.				Y					Y	11/11/2003	11/11/2003	0	NONE	PUB	PVT	Antibiotic D/T dental, does not remember name;	NONE	Seasonal pollen allergies;		ut032512	1						2	Hypersensitivity; Urticaria	FLU3~EVANS VACCINES~765878~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0215758	02/09/2004	MO	56.0	56		F	02/05/2004	Pt developed rash velups like on chestwall after flu shot.  Pt seen in ER and was given Benadryl 50mg IM, and solamedrol 125mg IM.				Y					Y	10/21/2003	10/21/2003	0	NONE	OTH	PUB	NONE	NONE	NONE			1						2	Urticaria; Hypersensitivity; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1095AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0216195	02/09/2004		40.0			F		A report was received from another manufacturer on 1/27/04, who received a report from a health care professional, concerning a 40 year old female vaccinee who experienced chest pain, abdominal pain, decreased appetite, lymphadenopathy, myalgia, pleural effusion, swelling over the entire body, and a rash which led to hospitalization and was considered to be life-threatening after receiving Fluvirin and Pneumovax 23 on 11/17/03. The vaccinee experienced chest pain, abdominal pain, decreased appetite and rash on the same day as, lymphadenopathy, myalgia, and swelling over the entire body three days after the pleural effusion approximately 7 days after receiving Fluvirin and Pneumovax 23. The vaccinee had a history of allergy to acetaminophen with codeine phosphate, depression, irritable bowel syndrome, possible bronchitis, gastroesophageal reflux disease and peptic ulcer disease. On 11/17/03, the vaccinee developed redness, warmth and pain. The vaccinee also experienced decreased appetite, a little chest pain, abdominal pain above the belly button and a minimal rash on the thigh. The vaccinee went to the local emergency room, was treated with prednisone and released. On the11/19/03, the vaccinee presented to the emergency room again with excruciating pain in her arm and swelling at the injection site. The vaccinee stated that within 3 days the site of injection had swelled to 5 inches in diameter. The vaccinee also experienced swelling at the lymph nodes, and over her entire body. She also stated that she could not raise her arm. The vaccinee was admitted to hospital on 11/19/03. While she was in the emergency room she was treated with morobine suphate and acetaminophen with hydrocodone bitartrate for a pain in muscle which did not relieve her pain. The site of vaccination was x-rayed and unspecified blood work was carried out, the results were not reported. A sedimentation rate was elevated and a white blood cell count was normal. On 11/24/03, an abdominal ultrasound showed that the liver, pancreas, kidneys, gall bladder, and spleen appeared normal. The impression was a normal abdominal ultrasound but the vaccinee was noted to have a small left sided pleural effusion. The vaccinee was discharged from hospital on 11/20/03. On 11/23/03, the vaccinee returned to the emergency room and was given prednisone which she stated did not help. Her white blood cell count was 7.6 K/uL (normal range 4.0 K/uL - 11.0 k/uL). On 11/25/03, the vaccinee was re-admitted to hospital, the swelling at the site of injection was 3 inches in diameter and the vaccinee was still having excruciating pain at the injection site. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.  Follow up on 03/22/04 states: Update 1, 03/01/04: A follow up report was received from another manufacturer, who received a report from a health care professional indicating that on 02/06/04, the vaccinee reported that her arm was still sore and that she was experiencing tingling in her fingers. The reporting health care professional also indicated that the vaccinee had not been seen for a while b/c she cannot come into the office b/c she cannot afford to be seen. Follow up pending.			Y		Y				U	11/17/2003	11/17/2003	0	On 11/24/03, an abdominal ultrasound showed that the liver, pancrease, kidneys, gallbladder, and spleen appeared normal. The impression was a normal abdominal ultrasound but the vaccinee was noted to have a small left sided pleural effusion. Absolute basophil count 0; absolute eosinophil count 76; absolute lymphocyte count 3192; absolute monocyte count 988; absolute segmented neutrophil 3344; basophil count 8 %; blood work: not reported; eosihophil count 1%; erythrocyte sed rate: elevated; hemocrit 41.7%; hemoglobin 13.5g/dl; lymphocyte count 42%; mean corpuscular hemoglobin 29.4; mean corpuscular hemoglobin count 32.4g/dl; heam corpuscular volume 91; monocyte count 13%; platelet count 295; FDW 13.3%; red blood cell count 4.6; segmented neutrophil 44%; serum alanine aminotransferase 24IU/L; serum albumin 3.7g/dL; serum alkaline phosphatase 97IU/L; serum amylase test 48u/l; serum aspartate aminotrasnferase 24IU/l; serum blood urea nitrogen 8mg/dl; serum calcium 8.5mg/dl; serum chloride 102mmol/l; serum creatinine 0.7mg/dl; serum glucose 97mg/dl; serum potassium 3.2mmol/l; serum sodium 140mmol/l; total serum bilirubin 0.4mg/dl; total serum protein 6.5g/dl; WBC 7.6; whole blood bicarbonate test 26mmol/L; x-ray at the site of vaccination: results not reported.	UNK	UNK	NONE		Allergy to acetaminophen with codeine; Depression; Irritable bowel syndrome; Possible bronchitis; Gastroesophageal reflux disease; Peptic ulcer disease		PJP200400116	1						1	Abdominal pain; Chest pain; Decreased appetite; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Lymphadenopathy; Myalgia; Pleural effusion; Red blood cell sedimentation rate increased; Swelling	FLU3~EVANS VACCINES~765703~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1196M~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0216197	02/09/2004	UT	68.0	68		F	10/27/2003	Received pneumococcal, Td, flu vaccine. Received pneumo in right arm. Red mass in arm, part of chest back area.  Joint pain, headache, nausea.									U	10/25/2003	10/25/2003	0	NONE	PUB	PUB	NONE	UNK	NONE		UT031811	1						1	Arthralgia; Headache; Injection site erythema; Nausea	FLU3~SANOFI PASTEUR~U1091AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0604N~UNK~~RA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U0849AA~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0216199	02/09/2004	OH	65.0	65		F	01/14/2004	Hard, hard breathing. Weakness, chest pains, confusion, coughing (constantly) lasting for 2 months.			Y	Y					Y	10/23/2003	11/10/2003	18		OTH	PUB	Estrace; Eloron	NONE				1						1	Chest pain; Confusional state; Cough; Dyspnoea	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~~PNEUMO (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0216202	02/09/2004	CA	47.0	47		F	12/02/2003	Pt noticed red rash starting as vasular appearing spots on abdomen and progressing to legs and feet, as both follicular rash as linear vasculitis, started 2 days after flu shot.									Y	11/22/2003	11/24/2003	2	UA: NEG	MIL	MIL	Fosingoril; Singulair; Flovent; Zyrtec; Zocor; ASA; Zantac;	NONE	Asthma; Hypertension; Allergic Rhinitis; GERD;			1						1	Rash; Vasculitis	FLU3~EVANS VACCINES~765416~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0216277	02/09/2004	MA	61.0	61		F	02/09/2004	The night of 12/19/04 after the injection experience of cramps in legs. With in 24 hours sudden extreme weakness in arms and legs, rapid pulse, extreme fatigue, strange sensations in legs of weakness and vibration, unable to lift a tea cup without fatiguing arms, chew without fatiguing jaw, had to lean on wall in shower, or walk up stairs. Crushing fatigue for two weeks. Still symptomatic in episodes after 8 weeks, varying by the day.				Y					U	12/19/2003	12/20/2003	1	Complete blood screening to rule out obvious illnesses; cardiac screen to rule out heart, neurological exams and reflex tests	PVT	UNK	none	none	none			1						1	Asthenia; Fatigue; Heart rate increased; Joint range of motion decreased; Muscle spasms	FLU3~EVANS VACCINES~755053~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0216245	02/10/2004	AR		31		M	11/14/2003	Pt got flu at 8:30am, then about 10:30, report from staff stating pt fainting in halls.  PT had asked for Tylenol prior to shot.  Pt seem lethargic, sweaty, clamming, somewhat hesitant to respond.  BP 180/100, temperature: 97.4, pulse: 72, respiratory: 24.  BS/2T.  PT sent to health care for evaluation.  Later sent to ER for high blood pressure, then discharged home about 15:00.				Y					U	11/14/2003	11/14/2003	0	NONE	OTH	PVT	NONE	UNK	NONE	Pt stated he had gotten sick 10 years ago after he was given flu shot 11/14/03.~Influenza (Seasonal) (no brand name)~1~0.00~In P	AR0804	1						1	Blood pressure increased; Cold sweat; Hyperhidrosis; Lethargy; Respiratory rate decreased; Syncope; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U1144AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0216246	02/10/2004	CA	1.8	1	.6	M	01/29/2004	Fluzone free 0.25ml in left thigh at 11:35.  12:00: Parents brought child back to clinic in respiratory distress auditory wheeze circumoral cyanosis lips cyanotic tongue cyanotic O2 SAT: 67%.  12:15: Cardiac monitors applied HR 23:04.  12:20: Benadryl 25mg in right thigh IM, O2 SAT: 97% R/A HR.  13:30: Discharge to home with care instructed.				Y					Y	01/29/2004	01/29/2004	0	NONE	MIL	MIL	NONE	Cough; Bilateral rhonci; Fever	NONE			1						1	Cyanosis; Respiratory distress; Wheezing	FLU3~SANOFI PASTEUR~U1106AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0216248	02/10/2004	CA	1.8	1	.7	F	02/02/2004	High fever (104.9) on Sunday morning, following vaccination on thursday morning.  Continues to have fever, although lower, on monday morning.				Y					N	01/29/2004	02/01/2004	3	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Pyrexia	DTAP~GLAXOSMITHKLINE BIOLOGICALS~21883B2~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1293AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0914M~3~IM~RL~HIB + HEP B (COMVAX)~1	USA	Emergency room visit	Influenza
0216284	02/10/2004	TN	9.0	9		M	02/04/2004	This case was considered medically important (OMIC). Information regarding FluMist was received from a consumer regarding a 9 year old male pt who developed pneumonia, the flu, and hives. The pt received a dose on 12/31/2003. A consumer reported that her son got the flu on 1/3/04, three days post-immunization; he developed a fever of 103.3 deg F, severe coughing and vomiting and experienced chills and aches. He was treated with Tylenol. On 1/11/04, he developed hives all over and was diagnosed with pneumonia. He was treated with Biaxin, Benadryl, and an unspecified decongestant. He recovered. As of 1/26/04, no additional info was available.									Y	12/31/2003	01/11/2004	11	UNK	PVT	PVT	NONE	UNK	UNK		HQWYE567927JAN04	1						1	Chills; Cough; Influenza; Pain; Pneumonia; Pyrexia; Urticaria; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216338	02/10/2004	OH	33.0	33		F	02/10/2004	Patient contacted with a concern that her current health problems (Fibromyalgia, Depression, Chronic Pain, History of Alopecia, Dizziness) may be due to vaccinations she received in 1998. HPI:  This patient reports a complete physical break-down that occurred from January-April 1999.  She was medically discharged from in July 1999.  She reports that she had a good career from 1986-1999.  In November 1998, she recalls receiving 2 sets of vaccinations.  (Her immunization records indicate receipt of Tetanus-diphtheria, pneumococcal, influenza, and Hep A vaccinations in December 1998.) In January 1999, she was routinely running 15-25 miles each week when she noticed that her muscles seemed to be losing their tone.  She began experiencing pain with running, particularly in her left leg.  She was diagnosed with a stress fracture.  Towards the end of January 1999, she started having pain with daily activity in her hips and shoulder area.  She saw a rheumatologist and was diagnosed with fibromyalgia.   In February 1999, the pain became more intense, and now she started having pain in her right wrist.  In April 1999, she developed bald patches the size of 50 cent pieces.  To work up the alopecia, she reports that hormonal levels were checked and were reportedly normal.  She was seen by a primary care PA and was referred to rheumatology.  She was reportedly told that she could be pre-menopausal.  (She was 33 years old at the time.)  Of note, she has a history of a partial hysterectomy due to uterine fibroids.  She was not satisfied with her evaluation and saw a civilian OB/GYN.  There, she was diagnosed with depression and started on Celexa 20 mg (later was increased to 40 mg).  She reports that she did notice some improvement in her pain. In July 1999, she requested a medical hardship.  She went to a nearby Hospital and was seen by rheumatology.  She had a series of X-rays and a CBC panel that was normal.  She also reports that her ESR has always been normal.  She was later referred to physical therapy, and her physical therapist requested a work-up for multiple sclerosis.  She was seen by a neurologist and had an MRI done, which was normal.  She was then referred to Neuropsychiatry where she was diagnosed with Somatoform Disorder.  Subsequently, she reports that she was seen by a psychiatrist who diagnosed her with Depression/Anxiety and not Somatoform disorder. She continues to receive follow-up treatment.  She is currently being treated for Fibromyalgia.  She continues to experience pain in bilateral shoulders, hands, back and neck.  The pain is worse when she is tired and after about 2 hours of physical activity.  She reports stiffness after periods of inactivity.  She has recently been switched from Celexa to Wellbutrin and is tolerating this medication well so far.  She reports no further alopecia.  She is seeking assistance to review her case and offer any further clinical suggestions.  She also questions whether or not her condition could be related to the vaccines she received in 1998.  She states that she still has daily symptoms and is unable to work.  She comments, I just want my life back. The medical records received on 2/24/04 states fatigue, joint aching, muscle ache, tendonitis, shin splints, decreased memory, decreased concentration, weight gain, dysthymia, anemia and headache. 60 day follow up 4/12/04: She continues to experience fibromyaglia and depression. The HC referred her to the specialized care program, but she denied. Her primary care physicain has referred her to a rheumatologist. After our summary is finalized, I will send a copy. Per annual report diagnosis of fibromyalgia and adjustment disorder are unchanged, managed by specialists 02/15/2005.				Y				Y	N	12/23/1998			Diagnostic Tests: oBone Scan-05/05/99:  Ordered due to c/o multiple joints pain including bilateral shoulders, knees, and hips.  Pain associated with wt bearing activities and running. oImpression:  Left tibial stress fracture.  Mild degenerative changes in the right first MCP joint and in the wrists bilaterally. o*** Following this test, she was referred to rheumatology for work-up of fibromyalgia. oDEXA Scan-9/27/99:  ordered to r/o osteoporosis following stress fracture oImpression-The bone density of the lumbar spine and left hip at all sites is within normal limits. oFindings:  Lumbar spine: -0.16 SD below the mean of age-matched normal women and -0.21 SD below the mean of peak density. oFindings:  L hip:  +0.87 SD above the mean of age-matched normal women and +0.80 SD above the mean of peak density.  The bone density of the femoral neck is +0.52 SD below the mean of her age group and +0.38 SD above the mean of peak density. oMRI Head W&W/O Contrast:  Ordered to r/o MS, pt. with report of numbness in hands and feet. oNormal MRI examination of the brain without and with contrast injection with no evidence of abnormal signal intensity within the brain tissue or abnormal enhancement.  If clinically MS is suspected, follow-up examination in a one-year interval is advised. o2/01:  LS plain films with mild hyperlordosis.  Laboratory Data: Hormonal Evaluation. Lab 2/16/01 1/19/01 11/15/00 8/04/99 5/21/99 Estradiol 86H 328 H 272 H   FSH 7.10 2.12 L 8.71 6.9 6.7 LH 3.69 1.85 38.61 H  28.9  CBC Lab 10/28/02 1/06/00 05/03/99 1/1l/99 HCT 38.2 37.0 37.8 38.3 HGB 12.8 L  13.0 12.8 WBC 7.5 6.8 7.7  RBC 4.06 L  4.13  Platelet 270 244 243   Chemistry Lab 8/04/99 Na 141 Cl 100 BUN 13 Glucose 113 H K 3.5 Cr 0.8 CO2 29.0  ESR Lab 10/28/02 02/01 05/03/99 ESR 5 12 6  Thyroid Panel Lab 10/28/02 08/04/99 05/03/99 Nml Range Free T4 0.95   .6-2 TSH 1.730 1.01 3.03 .3-5.5  Cholesterol 11 Jan 99  177 (0-200) Lyme ? 6/01   Negative RPR  05/03/99   Negative  2/01:  Per Rheumatology Note:  CD65 ANA Neg., EBV c/w previous infection, ESR 12.  CBC WNL.  Prev. tests with Normal TSH, HCV neg, LFT WNL.  28 Oct 02 Rheum F   < 20 (Nml) ANA    Neg Folate      10.84 (Nml) Vit B-12    609.2 (Nml)  U/A 11 Jan 99   Normal         03 May 99  Normal	MIL	MIL	No routine medications prior to 1999. Now taking: oWellbutrin 75 mg x 1 week (then will increase if tolerated).  oPreviously on Celexa. oMotrin prn	None	Past Medical History: oUterine Fibroids  oGestational Diabetes oAnemia during pregnancy oShe specifically denies any history of asthma, lupus, mononucleosis, cancer, hypertension, eczema, gallbladder disease, headaches/migraines, seizures, heart murmur, hernia, hepatitis, or thyroid disease.  Surgical History: oPartial Hysterectomy due to Uterine fibroids oBilateral Saline Breast Implants-1996  No known food or drug allergies. Mild lordosis.			1						1	Alopecia; Amnesia; Anaemia; Anxiety; Arrhythmia; Arthralgia; Asthenia; Depression; Dizziness; Fibromyalgia; Headache; Hypotonia; Laboratory test abnormal; Musculoskeletal stiffness; Myalgia; Neurosis; Pain; Pathological fracture; Tendonitis; Thinking abnormal; Weight increased	FLUX~UNKNOWN MANUFACTURER~Unknown~3~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~Unknown~1~IM~UN~HEP A (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~Unknown~1~IM~UN~PNEUMO (NO BRAND NAME)~1|TD~SANOFI PASTEUR~Unknown~2~IM~UN~TD ADSORBED (NO BRAND NAME)~1	USA	Disabling	Influenza
0216292	02/11/2004	CO	5.0	4		F	01/09/2004	Reported 01/09/04 about 30 days after influenza #1.  Mother claims child had complained of sore throat and cough 102 days after injection.  5 days after, red, multiple raised, scattered vesicular-blister like rash developed beginning on abdomen then moving to left arm.  3.5 weeks later, rash remains worse on left arm.  Mother claims she went to MD whom was unsure of rash or origin.  No complaints of itching, scratching, fever or pain, no swollen glands.									U	12/09/2003	12/11/2003	2	NONE	PUB	OTH	NONE	s/s of illness	NONE			1						1	Cough; Pharyngolaryngeal pain; Rash erythematous; Rash vesicular	FLU3~SANOFI PASTEUR~U1143AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0216293	02/11/2004	CO	1.0	0	.9	M	01/09/2004	Per mother, 1 day after vaccination; reddened, swelling at site to induration of 80x45mm (noted 30 days after injection); small red, raised pimpley rash over site.  Mother showed MD.  Brought to RN attention when pt brough in for 2nd flu shot.  Mother claims no temperature, cough or apparent discomfort at site, but redness apparent 30 days later, site measured.  No Benadryl per mother at time of initial reaction.  #1 dose preserv add multidose vial.									Y	12/07/2003	12/08/2003	1	NONE	PUB	OTH	NONE	NONE	NONE			1						1	Injection site induration; Injection site oedema; Injection site rash; Rash erythematous	FLU3~SANOFI PASTEUR~U1170AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0216294	02/11/2004	NJ	48.0	48		F	01/30/2004	Client contacted agency in PM of 01/29/2004 and reported urticaria developing at 16:30.  Took Benadryl spoke with MD, no other s/s.  Seen by MD 01/30/04 and diagnosed probable allergy to antibiotic Avelox (started AM 01/29/04).				Y					Y	01/29/2004	01/29/2004	0	NONE	PUB	PUB	Avelox;	Recoving sinusitis	Iodine dye allergy; Mastectomy; Hypertension; GERD;		NJ200401	1						1	Urticaria	FLU3~EVANS VACCINES~766050~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0216295	02/11/2004	NY	2.0	2	.9	M	01/27/2004	Mom reported redness and swelling at injection site extending to shoulder and elbow.									Y	12/09/2003	12/10/2003	1	NONE	PVT	PVT	Flovent MDI;	NONE	Asthma; Developmental allergies;			1						1	Injection site erythema; Injection site oedema; Oedema peripheral	FLU3~SANOFI PASTEUR~U1293ATT~4~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0216296	02/11/2004	GU	11.0	11		F	01/15/2004	Approximately 1.5 hours after vaccine administration, pt felt nauseated, clammy, racing heart, and dizzy/faint.  She was treated by parent-laying her down to rest, cool clothes on face.									Y	12/08/2003	12/08/2003	0	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Cold sweat; Dizziness; Heart rate increased; Nausea; Syncope	FLU3~EVANS VACCINES~765754~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0216371	02/11/2004	OH	4.0	3		F	02/11/2004	Previously healthy patient was admitted to hospital 10/22-10/23/03 and diagnosed with asthma and viral respiratory illness. Prior to discharge, influenza vaccine 0.5 mL was administered IM in left upper arm. Two days later family members noticed patient limping and c/o left lower extremity pain. Pain/inability to move LLE continued at home. Patient was readmitted 10/28/03 with diagnosis transverse myelitis vs. atypical Guillan-Barre.  MRI showed demyelinating lesion in lumbar spine. While hospitalized 10/28/03 to 12/3/03, patient received intravenous immune globulin, intravenous steroids, azithromycin and multiple other medications. During hospitalization family expressed concern about a possible speech/hearing problem but audiology consult revealed normal hearing in one hear, unable to assess other ear due to patient not cooperative. Patient required physicial therapy and brace to assist walking. Discharged to home 12/3/03 with plans to continue physical therapy.  Nurse follow up on 08/04/04 states: spasm. Discharge summary states fever. msv					Y	37		Y	N	10/23/2003	10/25/2003	2	MRI showed demyelinating lesion in lumbar spine. Multiple tests ordered including various Ig levels. csf abnormal; MRI abnormal; lab test abnormal	UNK	UNK	Albuterol, ipratroprium, prednisolone	Newly diagnosed asthma, viral respiratory illness	Asthma diagnosed the day prior to influenza vaccine; otherwise healthy. allergy Discharge summary states infection. msv			1						1	CSF test abnormal; Demyelination; Difficulty in walking; Joint range of motion decreased; Laboratory test abnormal; Muscle spasms; Myelitis transverse; Pain; Pyrexia; Skin ulcer	FLU3~SANOFI PASTEUR~U1089AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0216350	02/12/2004	TN	68.0	67		M	11/17/2003	Nauseated afterwards till night.  Flu-left arm, softball size swelling, went down next day but has stayed sore.  Pneumonia-right arm: knot and still very sore.  Prednisone to treat left arm and augmentin right arm.				Y					U	10/03/2003	10/04/2003	1	NONE	OTH	PUB	NONE	NONE	NONE			1						1	Injection site mass; Injection site oedema; Injection site pain; Nausea	FLU3~SANOFI PASTEUR~U1079AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0287N~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0216351	02/12/2004	VA	5.0	5		M	02/04/2004	Right arm where vaccine was given was swollen to elbow and chest.  Cellulitis type rash on area. Symptoms subsided after treatment with Prednisone and Atarax and Augmentin.				Y					Y	02/02/2004	02/02/2004	0	NONE	PUB	PUB	NONE	NONE	Asthma, other allergies are not physician diagnosed	~DTP (no brand name)~5~5.00~In Sibling	VA04002	1						1	Cellulitis; Injection site oedema; Rash	DTAP~GLAXOSMITHKLINE BIOLOGICALS~610A2~5~IM~RA~DTAP (INFANRIX)~1|FLU3~EVANS VACCINES~766321~1~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~W0704~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0129N~2~SC~RA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|VARCEL~MERCK & CO. INC.~1067M~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0216424	02/12/2004	CO	1.5	1	.5	M	02/06/2004	Pt. presented to ER at 8pm 2/5/04 after having received 6 immunizations earlier same day.  Child was having febrile seizures.  CBC done @ hospital with other tests done.  No medication given/prescribed. Child appeared to be OK  at PE 2/6/04. Medical record received on 3/23/04 states body ridged, arms shaking, lethargic, fussy, viral illness, emesis and eye infected.				Y					Y	02/05/2004	02/05/2004	0	CBC. CBC normal	PUB	PUB	none	none	Runny nose, cough		C004001	1						1	Agitation; Conjunctivitis; Febrile convulsion; Hypertonia; Lethargy; Tremor; Viral infection; Vomiting	DTAP~UNKNOWN MANUFACTURER~U1027CA~4~IM~LA~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~U1091AA~1~ID~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~0827N~4~IM~RA~HIB (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~0509N~1~IM~RA~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|PNC~PFIZER\WYETH~494381~4~IM~RA~PNEUMO (PREVNAR)~1|VARCEL~UNKNOWN MANUFACTURER~0883N~1~IM~LA~VARICELLA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0216387	02/13/2004	OH	78.0	78		F	02/05/2004	Funny feeling around mouth and extended down right side of neck beginning within 10 min after injection. Symptoms lasted for several hours particularly around mouth. Patient did no treatment, did report to primary care physician at next regularly scheduled appointment.									Y	10/21/2003	10/21/2003	0		OTH	OTH	Synthroid, Tylenol	NONE	Hypothyroid; partial right hip replacement 4/2000; NKA			1						1	Paraesthesia; Stomatitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0216462	02/14/2004	LA	47.0	47		F	02/14/2004	About 10 days after recieving the flu vaccine I noticed pain, numbness, and superficial burning sensation along the lateral side of my left arm extending to the small finger.  These symptoms continued for about 1.5 months.  I tool ibuprofen 400 mg about every 12-24 hours to control symptoms.  These symptoms have subsided.  I now have persistent weakness in my left arm and mild soreness along the outaspect of my left lower from below the deltoid to my midforearm.									U	11/04/2003	11/13/2003	9	None	PUB	PVT	Synthroid 0.1 mg daily	None	Hypothyroidism			1						1	Hemiparesis; Hypoaesthesia; Pain; Thermal burn	FLU3~SANOFI PASTEUR~U1094AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0216434	02/16/2004	NY	77.0	76		M		Initial SAE report received on 08/Dec/2003. Additional information received on 16/Dec/2003. This subject is a 77 year old male, who was admitted to the hospital due to SOB and peripheral edema while enrolled in a study. The subject received a dose of RSV or placebo and flu vaccine on 21/Oct/2003. The subject developed increased SOB and peripheral edema, 42 days post immunization. A CXR confirmed CHF and subject was admitted to ICU the same day, 2/Dec/2003. Subject was transferred to the floor and continued to have burning substernal chest pain and unstable angina. Treatment included a cardiac catheterazation on 10/Dec/2003. Subject developed acute renal failure possible secondary to the dye. A hemodialysis catheter was inserted on 15/Dec/2003 and dialysis was started. The subject's outcome is ongoing. It is unknown if they continued in the trial. The SOB and peripheral edema was reported by the investigator as unrelated to the study vaccine. Additional information received on 10/Feb/2004. The subject's spouse informed the investigator that her husband died while in the hospital on 8/Feb/2004. Subject died 68 days after admission to the hospital and 110 days post immunization. Cause of death is unknown at present. Information will be forward when available. The death was reported by the investigator as unrelated to the study vaccine. The hospital discharge summary received on 2/26/04 states respiratory failure and septicema.	Y	02/09/2004			Y				N	10/21/2003	12/02/2003	42	Cardiac catheterization 10/Dec/2003; Placement hemodialysis - 15/Dec/2003	UNK	UNK	Warfarin, Lasix, Avandia, Monopril, Synthroid, Quinine Sulfate, Valium, Zocor, Vioxx, Toprol, Exelon, Zetia, Norvasc		COPD, CHF, CAD, Atrial fibrillation, HTN, Diabetes, Osteoarthritis, hypothyroidism		200303306	1						1	Angina pectoris; Apnoea; Chest pain; Dyspnoea; Oedema peripheral; Renal failure; Sepsis	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|UNK~UNKNOWN MANUFACTURER~~UNK~IM~~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA	Results in Death	Influenza
0216441	02/16/2004	WV	56.0	55		M	10/23/2003	Pt is a 55 year old who received his first anthrax vaccination without any local adverse effects. On 2/15th, he received a smallpox vaccination as well a whole bunch of shots. Approximately three weeks after receiving his vaccinations, while sitting in the chow hall after supper, he says, my whole body started shaking and I felt weak. He was admitted to hospital where he received an EKG and a stress test. He was told that he had flutters and was kept overnight. The following morning he was told that both studies were normal and he was discharged. Approximately 1 week after he again experienced several episodes of shaking and feeling weak, sometimes accompanied by SOB and pressure across his chest (5-6/10 on pain scale). He was seen there by medics and given a NTG that helped but did not completely relieve his chest discomfort. These episodes continued and he was airevacuated on 4/27th where a cardiac cath showed a high-grade mid-LAD stenosis. He was to be transferred to another hospital for a stent placement, but he began experiencing additional left-sided chest pain (1-2/10) and on 5/6th a PCI and stent of his mid-LAD lesion was performed. A low-level exercise test performed 5/8th showed normal hemodynamic response and no EKG changes or symptoms. He was admitted to hospital 5/9/03 and followed by Dr. -minimal amount of redness and swelling.				Y	Y	15			Y	02/15/2003	03/07/2003	20		MIL	MIL	Simvastin; Folic acid; Clopidogrel; Rabeprazol sodium; Metaprolol; Ramipril; ASA; Rofecoxib; Ca	NONE	Demerol-itching; hay fever (grass); HTN; GERD; CAD; nephrolithiasis-1980s; spinal arthritis			1						1	Asthenia; Chest discomfort; Chest pain; Coronary artery disease; Dyspnoea; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~5377AA~UNK~~~HEP B (ENGERIX-B)~1|HEPA~MERCK & CO. INC.~0980M~UNK~~~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~U1233~UNK~~~POLIO VIRUS, INACT. (IPOL)~1|MEN~SANOFI PASTEUR~UB269AA~UNK~~~MENINGOCOCCAL (MENOMUNE)~1|SMALL~PFIZER\WYETH~4020071~4~~LA~SMALLPOX (DRYVAX)~1	USA	Hospitalisation	Influenza
0216442	02/16/2004	PA	47.0	47		M	02/13/2004	Approximately 12/14 or 12/15/03 onset numbness of right side (arm and leg). Numbness in R arm gradually resolved. Numbness extended to L leg. Pt experienced sensory changes including dragging leg. Increased weakness. MRI showed inflammation of spinal cord. Hospitalized and treated with steroids. Discharged home. Rested at home while strength returned. Improved; returned to work then 1/15/04 developed unsteady gait and readmitted to hospital on 1/16/04. Medical record states urinary retention. msv					Y				Y	11/12/2003	12/14/2003	32	MRI at end of December, 2003-inflammation of spinal cord T2-T6. Medical records state abnormal CSF. bacterial infection, ifection, urinary tract. msv	PUB	PVT			Herniated disc B L5 in past			1						1	Asthenia; Bacterial infection; CSF test abnormal; Gait disturbance; Hypoaesthesia; Laboratory test abnormal; Movement disorder; Sensory disturbance; Urinary retention; Urinary tract infection	FLU3~EVANS VACCINES~766049~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0216443	02/16/2004	NE				M	12/19/2003	Information regarding influenza virus vaccine was received from a 60 year old male consumer who received a dose in November 1964. The patient's concurrent illnesses include syncope vasovagal, anxiety, allergy to animal, hypersensitivity, and food allergy. Indication for influenza virus vaccine formula was immunization. Product was administered in November 1964. Dose regimen was not provided. Concomitant therapy included Clonazepam. The patient reported that he developed an injection site reaction, injection site arm redness, injection site arm hot, and injection site arm itching in November 1964. All symptoms resolved within 24 hours, without treatment. No additional information was available at the time of this report.									Y	11/01/1964	11/01/1964	0	UNK	MIL	MIL	UNK	UNK	Allergy to animal; Allergy to animal; Anxiety; Food allergy; Hypersensitivity; Syncope vasovagal		HQWYE210719NOV03	1						1	Injection site erythema; Injection site hypersensitivity; Injection site reaction; Injection site warmth; Pruritus	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0216444	02/16/2004	MS	1.0	1	.1	M	02/09/2004	Medical center called this nurse and stated child presented there with rash from head to foot.  Blanching and raised onset was about 3 days ago. Child received 5 immunizations on 01/28/04 at this clinic (see item 13) with no immediate adverse reaction advised parent of potential reaction to MMR.  Nurse follow up on 08/19/04 states: Viral exanthum.									U	01/28/2004	02/05/2004	8	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Rash; Rash erythematous; Rash	DTPHIB~SANOFI PASTEUR~U06907C~4~IM~LL~DTP + HIB (DTP + ACTHIB)~1|FLU3~SANOFI PASTEUR~U1111AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0389N~1~SC~RA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|PNC~PFIZER\WYETH~493872~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0195N~1~SC~LA~VARICELLA (VARIVAX)~1|DTAPH~SANOFI PASTEUR~U06907C~4~IM~RL~DTAP + HIB (TRIHIBIT)~2|MMR~MERCK & CO. INC.~0389 N~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~2|PNC~PFIZER\WYETH~493872~4~IM~RL~PNEUMO (PREVNAR)~2|VARCEL~MERCK & CO. INC.~0195N~1~SC~LA~VARICELLA (VARIVAX)~2	USA		Influenza
0216447	02/16/2004	WV	23.0	22		M	09/14/2004	Following smallpox vaccination (2 weeks-fever, diarrhea, nausea).  Also have Anthrax vaccine day this time.  History of experienced seen fatigue.  Work up to date-Normal except low testosterone level.  Anthrax shots started 03/02/03 and as listed below. Pt relates illness to immunizations.  Will send to clinic.									Y	03/21/2003	03/23/2004	368	Relational-low testosterone	MIL	MIL	Allegra as needed;	NONE	NONE			1						1	Blood testosterone decreased; Diarrhoea; Nausea; Pyrexia	ANTH~EMERGENT BIOSOLUTIONS~FAV073~1~IM~~ANTHRAX (BIOTHRAX)~1|FLU3~EVANS VACCINES~765754~6~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|SMALL~PFIZER\WYETH~4020071~3~~~SMALLPOX (DRYVAX)~1	USA		Influenza
0216475	02/16/2004	PA	88.0	88		F	02/16/2004	DAUGHTER CLAIMS THAT PATIENT DEVELOPED PNEUMONIA SECONDARY TO VACCINE.  VACCINATED 10/26/03, PNEUMONIA DIAGNOSED 12/11/03; PATIENT STILL NOT RECOVERED			Y	Y	Y	7		Y	N	10/26/2003	12/11/2003	46		PUB	UNK	NONE	NONE	HISTORY OF EMPHYSEMA AND BRONCHIECTASIS			1						1	Pneumonia; Pneumonia	FLU3~SANOFI PASTEUR~01132AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1132AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0214852	02/17/2004	WI	39.0			F	02/11/2004	From initial information received on 2/5/04 and additional information received on 2/10/04 from the Centers for Disease Control and Prevention regarding an adverse event occurring in the USA, it was reported that a 39 year old female patient received a first dose of YF VAX, lot number not reported, administered SC, a first dose of BIOTHRAX, lot number FAV073, administered SC, a second dose of HEPATITIS A VACCINE, lot number not reported, administered IM, a first dose of HEPATITIS B VACCINE, lot number not reported, administered IM, a fifth dose of INFLUENZA VACCINE, lot number not reported, administered IM, a second dose of MENOMUNE A/C/Y/W, lot number not reported, administered SC and a first dose of DRYVAX, lot number 4020071, administered ID on 1/29/03. Sites of administration were not reported. One week after receiving the vaccinations, the patient started to experience chest pain. She experienced similar chest pain the second week in February and at the end of March. She did not seek medical care until the chest pain episodes returned on 5/20/03. Patient reportedly was diagnosed with a non Q-wave myocardial infarction. Diagnostic tests revealed an elevated CPK (peak of 317) and elevated troponin (result not reported in available medical records), the patient was medically evacuated to a medical center. While at the medical center, her cardiac enzymes shoed to be abnormal with a peak CK of 98 (normal), elevated CK MB of 12, and elevated troponin of 21. A cardiac cath revealed a right dominant coronary system with branch vessel disease. The patient had a very small first obtuse marginal branch that had a 90% ostial lesion in it. She also had a 60% ostial moderate size diagonal branch lesion. Given the findings and continuous chest discomfort, the patient remained in the ICU and was placed on a full Bruce treadmill test. She did not develop any ischemic ECG changes on the treadmill. The patient's physician's did not feel that her chest pain was cardiac related. A PA/lateral chest x-ray revealed a blunt right hemidiaphragm consistent with a small effusion. The patient was hospitalized for three days. A repeat chest x-ray, obtained five days later, showed that the effusion had resolved. An abdominal ultrasound was performed, which was unremarkable other than a non distended gall bladder. A gastroenterology consult was obtained and an esophagogastroduodenoscopy was  performed, which revealed a small erosion on the antral portion of the stomach, but was not felt to be causal of the chest pain. She was placed empirically on Aciphex. While at the medical center, a psychiatry consult was obtained to evaluate the patient's eating habits, and she was diagnosed with anorexia nervosa of a restrictive type. No medications were started for this. She stayed at the medical center for 2-3 weeks before being transferred to another medical center for further evaluation. Her discharge medications include Lopressor 25mg twice daily, Plavix 75mg daily, Aciphex 20mg twice daily and Zocor. On 6/6/03, during cardiology evaluation, her EKG showed NSR, NL EKG. GXT Thall obtained on 6/9/03 showed moderate to severe diminished activity in her anterolateral wall after 12:56 minutes, which improves with rest. EF-55%, TTE (6/10/03): normal echography with EF 60-65%. Physician indicated that although her MPS showed ischemia in the anterolateral wall, her ability to exercise for 12:55 minutes without cardiac symptoms translates in a good prognosis. He also reported that the patient's chest pain was non-cardiac , but most likely musculoskeletal in nature and referred her to internal medicine. It was thought to likely be costochondritis and she was referred for an PA chest x-ray, which the records indicate were normal. At the time of vaccination, the patient also took vitamin E. After her myocardial infarction, she started Librax daily for hiatal hernia, rabeprazole 20mg twice daily, atenolol daily, Darvocet 100mg every eight hours as needed for pain, nitroglycerine spray as needed for chest paina nd an Epi-Pen for emergency use. Reportedly, the patient did not recover from these events. Additional info received 27FEB2004 through another company: Information was received which pertained to events that occurred 48 days after vaccination. This information contained the following adverse experiences: small effusion and anorexia nervosa. Chest pain and myocardial infarction were considered to be life threatening and to be other important medical events. Additional lab information was also provided. From additional information received on 04MAR2004 from the minutes of the CDC Yello Fever meeting, on 09FEB2004, it was reported that the pt did not seek medcal care until 20MAY2004 and was diagnosed with a myocardial infarction on 21MAY2003. No additional relevant information was provided for the adverse experience. This specific version is not submitted to the Health Authorities.			Y	Y	Y	3			N	01/29/2003	05/20/2003	111	5/21/03: glucose 94, BUN 8, creatinine 0.9, Na 137, K 4.1, Cl 107. CO2 21, CPK 138, 2nd CPK 317. 5/23/03: cardiac cath exam findings and impressions: right dominant coronary artery system with significant disease involving a very small branch of the circumflex system. Normal overall LV systolic function without segmental wall motion abnormalities or mitral regurgitation. Given the relatively small size of the affected vessel, the pt was not considered a good candidate for revascularization. 6/4/03: lung ventilation-perfusion scan exam findings and impression: area of relative photopenia corresponding in location to the oblique fissure of the left lung. Relative widening of this area of photopenia in the mid-lung. Additionally, there was mild, relatively decreased perfusion to the right lung apex. The mediastinal and cardiac silhouettes were normal in appearance. The ventilation images showed matching, though less prominent, areas of relative photopenia in the oblique fissure of the left lung and int he right apex. A moderate amount of gastrointestinal activity was observed in the ventilation images. Exam revealed matching, non segmental perfusion and ventilation defects with a pattern suggestive of fluid in the left oblique fissure consistent with a low probability for pulmonary embolism. 6/6/03 at 9:58 Coll + HIBV-1AB: negative, Coll-G6PD: normal. 6/9/03 at 7:08: myocardial perfusion (spect) multi-ST exam findings and impression: LVEF of 55% with normal wall motion. Under myocardial stress conditions, there was a moderate to severe diminished activity about the anterolateral wall, which improved in the resting conditions. This was in the distribution of the first diagonal vessel. The exam revealed an abnormal myocardial persusion study with findings consistent with ischemia in the anterolateral distribution consistent with first diagonal obstructive vessel. 6/11/03: chest x-ray findings and impression: there were normal lung volumes and lungs were clear. Cardiomediastinal silhouette and pulmonary vasculature were normal. Osseous structures were unremarkable. No acute disease found. At 13:28, cholesterol was elevated at 311 (50-200) mg/dL, LDL (direct) was elevated at 211 (0-129) mg/dL, VLDL was at 34, and CHOL TOT/HDL at 4.71. 7/5/03 at 8:40: albumin was low at 3.5 L (3.9-5.0) g/dL. 8/12/03f-echocardiogram cardiology impression: normal echo doppler. Overall left ventricular function was normal with an estimated EF of 60-65%. No pericardial effusion was seen and no valvular or structural abnormalities were noted. There were no intracardiac shunts. Doppler flows were normal. 8/14/03-myocardial imaging impression: negative stress test. No evidence of ischemia, normal wall motion and normal EG of 67%. 10/1/03-upper GI series impression: mild to moderate gastroesophageal reflux and a mild to moderate hiatal hernia were present. Findings suggestive of at least gastritis. Recommended treatment included treadmill exercise with rest and stress/cardiolite. A gastroenterology consult was obtained, and a esophagogastroduodenoscopy was performed, which revealed a small erosion o nt he antral portion of the stomach.	MIL	MIL	Vitamin E	NONE	Hiatal hernia; Gastritis; Migraines; Osteoarthritis of the left knee; Hyperlipidemia		200400453	1						3	Chest pain; Gastrooesophageal reflux disease; Laboratory test abnormal; Myocardial infarction; Skin ulcer; Anorexia nervosa; Chest pain; Laboratory test abnormal; Myocardial infarction; Pleural effusion; Anorexia nervosa; Blood creatine phosphokinase increased; Chest discomfort; Chest pain; Myocardial infarction	ANTH~EMERGENT BIOSOLUTIONS~FAV073~1~SC~UN~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~Unknown~5~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~Unknown~1~IM~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~Unknown~2~IM~UN~HEP A (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~Unknown~2~SC~UN~MENINGOCOCCAL (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4020071~1~ID~UN~SMALLPOX (DRYVAX)~1|YF~UNKNOWN MANUFACTURER~Unknown~1~SC~UN~YELLOW FEVER (NO BRAND NAME)~1|ANTH~EMERGENT BIOSOLUTIONS~FAV073~1~SC~UN~ANTHRAX (BIOTHRAX)~2|FLUX~UNKNOWN MANUFACTURER~~5~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEPA~UNKNOWN MANUFACTURER~~2~IM~UN~HEP A (NO BRAND NAME)~2|MEN~SANOFI PASTEUR~~2~SC~~MENINGOCOCCAL (MENOMUNE)~2|SMALL~PFIZER\WYETH~4020071~1~ID~UN~SMALLPOX (DRYVAX)~2|YF~SANOFI PASTEUR~~1~SC~~YELLOW FEVER (YF-VAX)~2|ANTH~EMERGENT BIOSOLUTIONS~FAV093~1~SC~UN~ANTHRAX (BIOTHRAX)~3|FLUX~UNKNOWN MANUFACTURER~~5~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|HEP~UNKNOWN MANUFACTURER~~1~IM~UN~HEP B (NO BRAND NAME)~3|HEPA~UNKNOWN MANUFACTURER~~2~IM~UN~HEP A (NO BRAND NAME)~3|MEN~SANOFI PASTEUR~~2~SC~~MENINGOCOCCAL (MENOMUNE)~3|SMALL~PFIZER\WYETH~4020071~1~ID~UN~SMALLPOX (DRYVAX)~3|YF~SANOFI PASTEUR~~1~SC~~YELLOW FEVER (YF-VAX)~3	USA	Life Threatening,Hospitalisation	Influenza
0216444	02/17/2004	MS	1.0	1	.1	M	02/09/2004	Child presented at hospital with rash from head to to, onset was three days ago.				Y					U	01/28/2004	02/05/2004	8	none	PUB	PUB	none	none	none		ms04002	1						2	Rash; Rash erythematous; Rash	DTPHIB~SANOFI PASTEUR~U06907C~4~IM~LL~DTP + HIB (DTP + ACTHIB)~1|FLU3~SANOFI PASTEUR~U1111AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0389N~1~SC~RA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|PNC~PFIZER\WYETH~493872~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0195N~1~SC~LA~VARICELLA (VARIVAX)~1|DTAPH~SANOFI PASTEUR~U06907C~4~IM~RL~DTAP + HIB (TRIHIBIT)~2|MMR~MERCK & CO. INC.~0389 N~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~2|PNC~PFIZER\WYETH~493872~4~IM~RL~PNEUMO (PREVNAR)~2|VARCEL~MERCK & CO. INC.~0195N~1~SC~LA~VARICELLA (VARIVAX)~2	USA	Emergency room visit	Influenza
0216469	02/17/2004	GA	74.0	74		F	02/10/2004	Pt complained of itching and welps on trunk and face friday evening. She called her PMD and he told her to take Benadryl and phone pt today.  She stated her face turned is still broke out.  Pt given a low dose of Prednisone by PMD.  Pt recovering now. Still has some on face and chest.									U	02/06/2004	02/06/2004	0	NONE	PUB	PUB	Prempro; Synthroid; MDI; Fosinex; HCTZ; Calcium; Folex;	NONE	Arthritis; Glucoma; hypothyroidism; Meneire's disease; Bone degeneration;	RASH in the 70's~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Rash pruritic; Urticaria; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U1291AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0216579	02/17/2004	MD	39.0	39		F	02/17/2004	I received the Flu Vaccine thru work and Twenty minutes after receiving the Flu Shot : I had severe chest pains and I passed out. I regained conciousness and went home for the rest of the day. My arm got red , & swollen. I broke out in hives and had a 103-104 degree fever. The needle hole weeped clear liquid. I got delirious and tried to cut my arm off with a butcher knife. I saw the company doctor. I also saw my Primary Care Physcian. They both told me that it was an allergic reaction to the Flu Vaccine and that I should never get it again or it would kill me.....   8 months later, I'm still having problems and went back to my primary care physican. He sent me for MRI's and Sonograms on my arm and to a Surgeon. They found 7 small (5mM)  areas of Fluid but concluded that they would re-absorb into my body and that they were Sterile Abscesses. They never cultured them though , but they concluded that they were Sterile abscesses like children get when they get a shot. I've been putting up with this pain and constant symptoms for 2 1/2  years now. I recently have been in severe pain and now am on Oxycoten and Tramadols so I can function to go to work. I also was told that they found a Mass in my left breast now, because I went to the Hospital 2 days before Christmas (2003) because I was in so much pain that I thought that I was dying. I went for Mammagrams , sonograms, MRI's on my arm and sonograms for my arm. I have went to a Breast surgeon specialist and have had to have a Stereotactic Core Biopsy done on my left breast . Thank God they have told me that it's not cancer but then I have to ask... what the heck is it? The Flu Shot was given 2 1/2 years ago........ and I still have the needle hole and it still weeps liquid out of it and it still gets red and swollen and I break out in hives and I get fevers and I have severe pain that I've been on heavy pains killers for over 3 months now. I have exhausted my sick leave and my vacation here at work... I am now taking time off as Leave Without Pay. Can you help me? I dont' know where else to go and what else a doctor can do for me; I need help.  ps. I don't know that Lot# of the Flu Vaccine that I got or the Specific Mftg. Name ; but my old Boss is helping me find out the information.  I would appreciate any help that you can give me.  Thank you. 11/10/06 Received medical records from 2nd hospital which reveal patient seen in ER only on 12/22/03.  Hospital states has no record of patient visit in 2001.   HPI: left side pain of arm, chest & abdomen x several weeks.  Patient stated had sterile abscess of left arm from flu vax evaluated by surgeon who advised to just monitor.  Stated she was in hospital with MI after flu shot created allergic reaction. EXAM: tenderness over left chest. 11/10/06 Received medical records from 3rd hospital which consisted only of left breast biopsy report of fibroadenoma.  T/C to MR dept confirmed that is only records they have of patient for 2004. 11/28/06 Received medical records from first hospital which are from 1994 & only records available at hospital for unrelated liquid hydrocarbon splash into eyes.  Was treated & released from ER.			Y	Y				Y	N	11/22/2001	11/22/2001	0	MRI, Sonograms, Blood Work, Urinalysis, x-rays, Allergy Tests/ Screening, Stereotactic Core Biopsy on my left Breast. LABS: WBC 11.4, Amylase 42, EKG WNL, abdominal xray WNL	UNK	UNK	Avalide ( High Blood Pressure Med).	None other than the Allergic Reaction symptoms that came from the Flu Vaccine	None Medical records states Hx of CA of breast.  PMH: cervical cancer, HTN, MI, left breast mass, asthma.  ETOH & cigarette abuse.			1						1	Abscess; Breast neoplasm; Chest pain; Erythema; Hypersensitivity; Injection site abscess; Loss of consciousness; Pain; Pyrexia; Swelling; Thinking abnormal; Urticaria	FLU3~SANOFI PASTEUR~~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Disabling	Influenza
0216487	02/18/2004	WA		2	1	M	12/09/2003	Child given .25mg flu vaccine (appropriate for age) by time parents got to check-out child c/o throat hurting and covered in hive-like rash. Epinipherine .5mg/ 1000 given SC 911 called. Sent to ER. Given Benadryl orally and prednisone x 3 days. F/U 3 days later child had cold/ cough and had been seen by PMD.			Y	Y					Y	12/05/2003	12/05/2003	0	Allergy testing 12/11/0 by pediatric allergist.	PUB	PUB	Prednisone	NONE	NONE		WA031989	1						1	Cough; Pharyngitis; Pharyngolaryngeal pain; Rhinitis; Urticaria	FLU3~SANOFI PASTEUR~U1170AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0216488	02/18/2004	WA	61.0	61		F	12/15/2003	L upper arm is sore, a #2 on scale of 1-10. Most of the time even when not in use since received 11/4/03 vaccine. 12/29/03-states arm continues sore without swelling. She is to see chiropractor to see if back related.									N	11/04/2003	11/06/2003	2	NONE	OTH	PVT	Lipotar, alenolol, Hyarsiuretis	NONE	L of spine and L arm tingling in last few weeks saw MD and referred for massage secondary to possible impingement		WA031984	1						1	Tenderness	FLU3~SANOFI PASTEUR~U1132AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0216489	02/18/2004	WA	41.0	40		F	01/12/2004	Morning post vaccination, raised red and itchy area about baseball size. Lasted intensely one day then tapered off for 2 more days.									Y	10/23/2003	10/24/2003	1	NONE	OTH	OTH	Advil (occasiona)	NONE	Allergy to PCN and derivatives; bee stings; grasses		WA042012	1						1	Erythema; Pruritus; Rash maculo-papular	FLUX~UNKNOWN MANUFACTURER~~4~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0216490	02/18/2004	WA	25.0	25		M	01/30/2004	2 d post vaccine, arm really sore, head cold coughing, sneezing. 2 more days had anorexia, diarrhea, resolved after about a week.				Y					Y	12/13/2003	12/13/2003	0	NONE	OTH	OTH	NOEN	NONE	NONE		WA042011	1						1	Anorexia; Cough; Diarrhoea; Pharyngitis; Rhinitis; Sneezing; Tenderness	FLUX~UNKNOWN MANUFACTURER~~3~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0216491	02/18/2004	WA	41.0	41		F	01/02/2004	Extra large area on L upper arm was hot to be touch and hard and painful for a solid week after the vaccination. Area almost four in diameter.									Y	10/09/2003	10/09/2003	0		OTH	OTH					WA042007	1						1	Injection site induration; Injection site pain; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0216492	02/18/2004	WA	51.0	51		F	01/21/2004	Arm swelled up the size of a baseball, was very red, hot and had red streaks going down the arm. She called her doctor but he didn't call back so she let it go. Resolved post 7 days.									Y	10/01/2003	10/01/2003	0	NONE	OTH	OTH	Tropol XE, Benestin	NONE	Rapid heart rhythm-seasonal allergies		WA042008	1						1	Erythema; Injection site warmth; Oedema peripheral; Skin striae	FLUX~UNKNOWN MANUFACTURER~~7+~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0216493	02/18/2004	WA	29.0	29		F	01/26/2004	Red blotchiness around injection site-(doesn't remember which arm) 1/2 in size. Slightly swollen and tender. Lasted approx. 1-2 days. Has had flu vac for approx. 20 yr-never developed rash before.									Y	10/01/2003	10/01/2003	0		OTH	OTH	Proventil inhaler prn basis	NONE	Dairy food allergies, acute ashma, Von Willabrand disorder		WA042009	1						1	Injection site erythema; Oedema peripheral; Rash macular; Tenderness	FLUX~UNKNOWN MANUFACTURER~~7+~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0216494	02/18/2004	WA	46.0	46		M	01/07/2004	Chills, fever, nausea, achy for 14 days, sl.				Y					Y	10/03/2003	10/04/2003	1	NONE	OTH	UNK	Synthroid	NONE	Thyroid		WA041998	1						1	Chills; Nausea; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0216495	02/18/2004	WA	34.0	34		F	01/08/2004	Sore throat for several days and sinus congestion felt run down sx stayed thru mid Dec.									Y	10/30/2003	11/01/2003	2	NONE	OTH	OTH	NONE	NONE	NONE		WA041999	1						1	Pharyngolaryngeal pain; Sinus congestion	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0216496	02/18/2004	WA	57.0	57		F	01/07/2004	Arm became itchy, hard, red and warm lasted 4-5 days.									Y	10/09/2003	10/09/2003	0	NONE	UNK	UNK	Synthroid, Avcindia	NONE	Type II diabetes		WA042000	1						1	Erythema; Feeling hot; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0216497	02/18/2004	WA	39.0	39		F	01/08/2004	Experienced fever and chills, sweating lasted few hours.									Y	10/30/2003	11/01/2003	2		OTH	OTH	NONE	NONE	Allergic to sulpha and amoxicillin		WA042001	1						1	Chills; Hyperhidrosis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0216498	02/18/2004	WA	54.0	54		F	01/07/2004	Experienced chills and shaking, body aches for 6-8 hours.									Y	10/30/2003	10/31/2003	1	NONE	OTH	OTH	Presciption for bladder infection	Bladder infection	NONE		WA042002	1						1	Chills; Pain; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0216499	02/18/2004	WA	46.0	46		M	01/14/2004	Large bruise on left upper arm-became black and blue almost immediately.  Approximately 10 inch long width of his biceps.  has had previous flu shots, never bruising.  Felt wierd on and off for 30 days after getting shot.  Due to the circumstances of vaccination that generated this VAERS report, the vaccine manufacturer, the lot number, the injection site and the providers name and phone number were not available to us.									Y	10/20/2003	10/20/2003	0	NONE	OTH	OTH	Norvasc/Ziac;	NONE	NONE		WA042003	1						1	Contusion; Feeling abnormal	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0216500	02/18/2004	WA	54.0	54		M	01/16/2004	Right joint pain in elbow and shoulder-started about 5-7 days after shot.  Still hurts.  Present always worse sometimes than others. Due to the circumstances of vaccination that generated this VAERS report, the vaccine manufacturer, the lot number, the injection site and the providers name and phone number were not available to us.									Y	10/02/2003	10/08/2003	6	NONE	OTH	OTH	Lipitor;	NONE	NONE		WA042004	1						1	Arthralgia; Shoulder pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0216502	02/18/2004	WA	52.0	52		M	01/07/2004	Symptoms began on or about Halloween.  Diarrhea and fever, saw MD 2nd week of November.  Started antibiotics for bladder infection; pain in bladder.  Cipro finished-2 weeks.  Due to the circumstances of vaccination that generated this VAERS report, the vaccine manufacturer, the lot number, the injection site and the providers name and phone number were not available to us.				Y					U	10/01/2003	10/31/2003	30	WBC's in urine culture (+) for E. Coli. Blood work done to look for other problems.	OTH	OTH	Hypertension meds; Celebrex;	NONE	Hypertension; Knee joint arthritis;		WA041997	1						1	Bladder pain; Cystitis; Diarrhoea; Laboratory test abnormal; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0216503	02/18/2004	WA	52.0	52		F	01/07/2004	Day after shot had red 50 cent size spot at injection site, not painful.  Lasted 4-5 days then gone.  2 weeks ago, noted a ring of blisters and dried lesions around front of neck triple antibiotic cream got rid of it.  After 2-3 days.  3 days later same thing under left breast.  2 days later same on chest, still there. Due to the circumstances of vaccination that generated this VAERS report, the vaccine manufacturer, the lot number, the injection site and the providers name and phone number were not available to us.				Y					N	11/05/2003	11/06/2003	1	MD appointment 01/08/04	OTH	OTH	Vitamins, Fish oil, Ca#;	NONE	NONE		WA041996	1						1	Blister; Injection site erythema; Skin ulcer	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0216504	02/18/2004	WA	39.0	39		F	01/07/2004	24 hours after shot, bright red about 4 inch spot, raised about 1/4 inch, a little sore but felt hot; lasted 4-5 days then to a bruise for a week, then gone.  Had about 3 weeks of flu-like symptoms a month after vaccine. Due to the circumstances of vaccination that generated this VAERS report, the vaccine manufacturer, the lot number, the injection site and the providers name and phone number were not available to us.									Y	10/07/2003	10/08/2003	1	NONE	OTH	OTH	BCP's	NONE	NONE		WA041995	1						1	Contusion; Influenza like illness; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~7+~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0216505	02/18/2004	WA	46.0	46		F	01/07/2004	Localized skin reaction over injection site (left arm) began within 24 hours after injection.  Red, itchy, and swollen.  Lasted 3-4 days.  Vaccine Friday-improving by Monday. Due to the circumstances of vaccination that generated this VAERS report, the vaccine manufacturer, the lot number, the injection site and the providers name and phone number were not available to us.									Y	10/23/2003	10/24/2003	1	NONE	OTH	OTH	NONE	NONE	NONE		WA041994	1						1	Injection site erythema; Injection site oedema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~7+~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0216506	02/18/2004	WA	42.0	42		F	01/09/2004	Day after vaccine, 2.5-3 inch ring-like rash on back of left arm above elbow. Like bulls-eye.  Area was tender too.  Lasted 3 days. Due to the circumstances of vaccination that generated this VAERS report, the vaccine manufacturer, the lot number, the injection site and the providers name and phone number were not available to us.									Y	10/23/2003	10/24/2003	1	NONE	OTH	OTH	Vitamins; BCP's;	NONE	NONE		WA041993	1						1	Pain; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0216507	02/18/2004	WA	34.0	34		F	01/06/2004	Raised bumpy rash began about 2 hours after vaccination over left triceps about the size of a pop can by the next day.  Burning and itching for 1 week.  Area stayed large about 7-10 days.  Used hydrocortisone and calamine to treat symptoms.  Still has a little residual bumpiness and irritation. Due to the circumstances of vaccination that generated this VAERS report, the vaccine manufacturer, the lot number, the injection site and the providers name and phone number were not available to us.									Y	10/23/2003	10/23/2003	0	NONE	OTH	OTH	Claritin; Nasonex;	NONE	Lots of allergies-none to meds (food, mold/mildew);		WA041992	1						1	Rash erythematous; Rash pruritic; Skin burning sensation; Skin irritation	FLUX~UNKNOWN MANUFACTURER~~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0216508	02/18/2004	WA	23.0	23		M	01/06/2004	Tightness in right calf, got worse, to ER for ultrasound.  Diagnosis was blood clot.  Now on blood thinners.  Cause unknown. Began a few weeks after vaccination. Due to the circumstances of vaccination that generated this VAERS report, the vaccine manufacturer, the lot number, the injection site and the providers name and phone number were not available to us.				Y					Y	10/23/2003			NONE	OTH	OTH	Zirtec;	NONE	Dust allergy; Sulfa; Ibuprofen;		WA041991	1						1	Muscle spasms; Thrombosis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0216509	02/18/2004	WA	30.0	30		M	01/09/2004	Got shot on Thursday, started to feel bad on Friday: achy, feverish, decreased appetitie, no nausea, vomiting or diarrhea.  Lasted through Monday.  No problems at injection site. Due to the circumstances of vaccination that generated this VAERS report, the vaccine manufacturer, the lot number, the injection site and the providers name and phone number were not available to us.									U	10/23/2003	10/24/2003	1	NONE	OTH	OTH	NONE	NONE	NONE		WA041990	1						1	Decreased appetite; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~3~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0216510	02/18/2004	NY		25		M	02/07/2004	Became lightheaded, nausea, dizzy, 1 episode vomiting after bloodwork and vaccines completed.									Y	02/04/2004	02/04/2004	0	HIV hemogram done 02/04/04	MIL	MIL	NONE	NONE	NONE			1						1	Dizziness; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U1271AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~9536201~UNK~IM~RA~HEP A (VAQTA)~1|MEN~SANOFI PASTEUR~UB493AA~UNK~SC~RA~MENINGOCOCCAL (MENOMUNE)~1|TYP~SANOFI PASTEUR~X01102~UNK~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0216642	02/18/2004	WA	58.0	57		F	02/18/2004	Severe muscle pain at injection site beginning two days after immunization and continuing to date. No edema, redness, or warmth at injection site. Pain continues to interfere with sleep. Some relief with hot packs and pain medication.									U	10/09/2003	10/11/2003	2		UNK	UNK	Nexium	None	arthritis; environmental allergies			1						1	Injection site pain; Myalgia; Sleep disorder	FLU3~SANOFI PASTEUR~U1090AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0216475	02/19/2004	PA	88.0	88		F	02/13/2004	From initial information received on 2/12/04 from a consumer regarding an adverse event occurring in the USA, it was reported that an 88 year old female patient received FLUZONE, lot number U1132AA, administered on 10/26/03. The route and site of administration were not reported. 46 days later, on 12/11/03, the patient developed viral pneumonia and was hospitalized for one week. Treatment included IV antibiotics. The patient is still ill and has not recovered from this adverse event. 22Sep2004: Despite continued attempts to obtain follow up, no further information was provided. No further information is anticipated, this case is considered closed.					Y				N	10/26/2003	12/11/2003	46		PVT	UNK		NONE			200400492	1						2	Pneumonia; Pneumonia	FLU3~SANOFI PASTEUR~01132AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1132AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0216590	02/19/2004	CO	1.0	1	.0	M	02/09/2004	#2 flu vaccine adm. R thigh on 1/9/04. 24 hrs post vacc. site became red, raised, individual, small bumps in localized area approx. 1.5 wide x 3-4 long. No apparent pain, itching, no fevers. No OTC meds or heat/ cold packs applied. No limit to activity. (+) warm to touch rxn appeared to be concentrated to skin surface. Site still visible. Skin rough, skaley almost excema appearance. Now applying (and had) lotion. (+) rxn to vaccine #1. Has eaten egg containing products w/o problems-no eggs alone consumed to date that father is aware of.									Y	01/09/2004	01/10/2004	1	NONE	PUB	UNK	NONE	NONE	NONE	Skin rough, skaley almost excema appearance. Now applying (and had) lotion. (+) rxn to vaccine #1.~Influenza (Seasonal) (Fluzone		1						1	Injection site erythema; Injection site rash; Injection site swelling; Injection site warmth; Skin exfoliation	FLU3~SANOFI PASTEUR~U1231BA~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0216591	02/19/2004	MI	1.01	1	.0	F		Rash-abdomen/ thorax (erythematous macular papular diffusely over thorax/ abdomen). No fevers.  follow-up 2/11/2010 - information has been received from a nurse practitioner concerning a caucasian female child. recently diagnosed with carnitine deficiency and probable mitochondrial defect. who was vaccinated subcutaneously in the right thigh, with 0.5 ml on 29 dec 2006 with her first dose of measles virus vaccine live, + mumps virus vaccine. live  + rubella virus vaccine live, varicella virus vaccine live (oka/merck upgrade process) (lot # 656308/3392f). on that same day, at 6pm, the child developed three poxes near the injection site noted to be a varicella-like injection site reaction. these poxes went away after a few days. two weeks later, on approximately 12 jan 2007, the patient developed four to five poxs on various locations on her body. the patient recovered on 19 jan 2007. no laboratory or diagnostic studies were performed. unspecified medical attention was sought. there was no product quality complaint involved.									Y	10/29/2003	11/06/2003	8	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Carnitine deficiency; Injection site rash; Mitochondrial enzyme deficiency; Rash erythematous; Rash maculo-papular	FLU3~SANOFI PASTEUR~U1075AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0663N~4~~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0511N~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0216626	02/19/2004	FL	50.0			F	01/23/2004	Information regarding FluShield was received from a consumer, a 50 year old female patient who experienced injection site reaction, the site was big, red, hot. At 50 years of age, the patient received a dose in 2000. The patient's concurrent illness includes hypothyroidism. Indication for Flu Shield was prophylaxis. Product was administered in 2000. Dose regimen was 1 dose per 1 time per day (IM). Concomitant therapy included Synthroid. In 2000, the patient developed an injection site reaction. The patient described the site as being big, red, hot. The event resolved with rubbing and massage. No additional information was available at the time of this report.									Y				UNK	PVT	OTH	Synthroid	UNK	UNK		HQWYE507621JAN04	1						1	Injection site erythema; Injection site reaction; Injection site warmth	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0216627	02/19/2004	OK	41.0			F	01/02/2004	A 43 year old female reported that she received an IM injection of a flu vaccine in 2000 at the age of 41 years, and experienced a red knot under her arm that would itch for several days and then resolve. The patient reports she has a possible allergy to preservatives. In 2001 and 2002, after receiving a flu vaccine, the patient experienced a red knot under her arm that would itch for several days and then resolve. Indication for the flu vaccine was immunization. Product was administered in 2000. Dose regimen was 1 dose (IM). Patient was not taking concomitant therapy. After receiving an IM injection of a flu vaccine in 2000, the patient experienced a red knot under her arm that would itch for several days and resolve. No additional information was available at the time of this report.									Y				UNK	PVT	PVT	NONE	UNK	Hypersensitivity		HQWYE838007NOV03	1						1	Pruritus; Subcutaneous nodule	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0216628	02/19/2004	FL	49.0			F	01/23/2004	Information regarding Flu Shield was received from a consumer, a 49 year old female patient who experienced injection site reaction, the site was big, red, hot. At 49 years of age, the patient received a dose in 1999. The patient's concurrent illness includes hypothyroidism. Indication for Flu Shield was prophylaxis. Product was administered in 1999. Dose regimen was 1 dose per 1 time per day (IM). Concomitant therapy included Synthroid. In 1999, the patient developed an injection site reaction. The patient described the site as being big, red, hot. The event resolved with rubbing and massage. No additional information was available at the time of this report.									Y				UNK	PVT	OTH	Synthroid	UNK	UNK			1						1	Injection site erythema; Injection site reaction; Injection site warmth	FLU3~PFIZER\WYETH~~UNK~SC~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0216629	02/19/2004	FL	48.0			F	01/23/2004	Information regarding Flu Shield was received from a consumer, a 48 year old female patient who experienced injection site reaction, the site was big, red, hot. At 48 years of age, the patient received a dose in 1998. The patient's concurrent illness included hypothyroidism. Indication for Flu Shield was prophylaxis. Product was administered in 1998. Dose regimen was 1 dose 1 times per 1 day (IM). Concomitant therapy included Synthroid. In 1998, the patient developed an injection site reaction. The patient described the site as being big, red, hot. The event resolved with rubbing and massage. No additional information was available at the time of this report.									Y				UNK	PVT	OTH	Synthroid	UNK	Hypothyroidism		HQWYE789019DEC03	1						1	Injection site erythema; Injection site reaction; Injection site warmth	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0216630	02/19/2004	CA				F	08/21/2003	Follow-up information received 15-AUG-2003 provided medical history, event onset date, treatment medications, and outcome. A physician reported that a 44-year-old female received an injection of influenza virus vaccine (manufacturer unknown) on 16-NOV-1994. The patient's medical history included an allergy to cats, hypertension, migraine headaches, and low thyroid. That same day, she was seen in the ER for an anaphylactic reaction characterized by generalized erythema, pruritis, throat tightness, and SOB. She was treated with SC epinephrine, IV and oral Benadryl (diphenhydramine), physician reported that the pt ate chicken and potatoes 1-2 hours prior to onset of symptoms. This event was considered medically important (OMIC).				Y					Y	11/16/1994	11/16/1994	0	UNK	OTH	OTH	Premarin, Provera, Tolectin, Triavil	UNK	Allergy to animal, hypertension, hypothyroidism, migraine		HQWYE918709JUL03	1						1	Anaphylactic reaction; Dyspnoea; Erythema; Pruritus; Throat tightness	FLU3~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0216631	02/19/2004	AZ				M	08/12/2003	Information was received from a 64 year old male patient who is a health care professional, who, 10 years ago, at the age of 54, received a dose of influenza virus vaccine trivalent, types A &B, Flu Shield. Ten days following administration of the vaccine, he experienced pain and numbness on the right side of his face. The symptoms lasted for 6 weeks. No treatment was prescribed. No further information was available at the time of this report.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQWYE850303JUL03	1						1	Hypoaesthesia; Pain	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0216632	02/19/2004	NE				M	12/19/2003	Information regarding influenza virus vaccine was received from a 60 year old male consumer who received a dose in 1993. The patient's concurrent illnesses include syncope vasovagal, anxiety, allergy to animal, hypersensitivity, and food allergy. Indication for Flu Shield was immunization. Product was administered in 1993. Dose regimen was not provided. Concomitant therapy included Clonazepam. The patient reported that he developed an injection site reaction, injection site arm redness, injection site arm hot, and injection site arm itching in 1993. All events resolved within 24 hours, without treatment. No additional information was available at the time of this report.									Y				UNK	MIL	MIL	UNK	UNK	Allergy to animal; Anxiety; Food allergy; Hypersensitivity; Syncope vasovagal		HQWYE448205DEC03	1						1	Injection site erythema; Injection site hypersensitivity; Injection site reaction; Injection site warmth; Pruritus	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0216633	02/19/2004		10.0			M	12/15/2003	Information regarding influenza virus vaccine, trivalent, A&B, was received from a consumer regarding a 24 year old male patient who experienced red striations out from injection site and injection site reaction. At 10 years of age, the patient received a dose on an unspecified date. No allergies to eggs. Indication for influenza virus vaccine, trivalent, A&B was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Patient was not taking concomitant therapy. On an unspecified date, sometime during 1988-1989, at the age of 10 years, the patient received a dose of influenza virus vaccine and developed an injection site reaction of the arm characterized by red striations radiating out from the injection site. The reaction lasted for a day or so and resolved with an unknown dose of Benadryl. No additional information was available at the time of this report.									Y				UNK	PVT	OTH	NONE	UNK	UNK		HQWYE450705DEC03	1						1	Cellulitis; Injection site reaction	FLU3~PFIZER\WYETH~~UNK~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0216696	02/19/2004	LA	21.0	21		F	02/19/2004	During the mid to late part of November 2003, the client reports that she experienced fever, chills, and night sweats. She also developed recurrent left subclavicular lymphadenopathy, which was reported larger than previously noted. Again she thought that this was related to her vaccination and just sucked it up and did her assigned job. On 15 December 2003, she could no longer live with the symptoms. She reports that her supervisors said she was not tracking right  and was not herself. She report to sick call and was evaluated. In addition to her previous symptoms she developed a sore throat (9/10) and had difficulty staying awake. He hemoglobin was 11.2, hematocrit 31.3, WBC 2.8 and platelets 78. She was diagnosed with URI, R/O strep throat and anemia. She was placed sick in quarters (SIQ) for 24 hours. In addition, she received 1.2 million units of Bicillin IM and given instructions to return to clinic (RTC) if conditioned worsened.  On 16 December 2003, the client returned to sick call for follow-up care. She stated no improvement of symptoms, and had developed diarrhea. A Monospot and rapid strep test were done to R/O mononucleosis and strep throat. Both tests were negative, as was the throat culture (reported on 27 Dec 03). A complete blood count (CBC) was again drawn and revealed hemoglobin 11.2, hematocrit 31, WBC 2.7, and platelets 90. She was once again placed SIQ for 48 hours and started on Azithromax for suspected mononucleosis. She was instructed to follow-up in the AM, however no documentation exists in her medical file to document follow-up.  On 27 December 2003, the client once again reported to sick call at 1515 hours.  She stated that she experienced nausea and vomiting every time she ate for the previous week. She was also experiencing fever and chills that resolved with Tylenol. She was also experiencing night sweats from which she says she awakens soaked. The medical records reflects an ~ 11 pound weight loss over a ~ 6 month period. The client related feeling very weak and without appetite.  Physical examination, according to the medical records, revealed left retro-sterno cliedomastoid lymphadenopathy along with left supraclavicular lymphadenopathy. Completed blood count revealed hemoglobin 10.1, hematocrit 26.8, WBC 2.9 and platelets 126.  In addition, her calcium was low at 8.1, phosphorus low at 2.3, alkaline phosphate low at 35 and LDH elevated 280. An analysis of a blood smear revealed hypochromatic, microcytic erythrocytes, few reactive lymph, no blast cells or teardrop erythrocytes or schistocytes. Her erythrocyte sedimentation rate (ESR) was elevated at 40. She was diagnosed with pancytopenia with associated neck Adenopathy and elevated ESR and LDH. The decision was made to Medivac the client for definitive anemia workup.  On 31 December 2003, the client was aeromedical evacuated.  The physical examination located in the client's medical records reveals bilateral anterior cervical lymphadenopathy with three (3) palpable nodes on the left and one (1) and one (1) lower occipital region, otherwise exam was normal. Review of laboratory data for admission revealed hemoglobin  10.1, hematocrit 31.1, WBC 2.2 and platelets 146. Her anti-neutrophilic cytoplasmic antibody (ANCA) was elevated at 814. While a patient, laboratory studies were done including sickle cell screen, Parvo, EBV, CMV and malaria titers. The EBV and malaria titers were negative, as was a sickle cell screen.  Her CMV and Parvo were, as expected, positive. Anemia work-up revealed a serum iron low at 45, ferritin high at 491, B12 and folate were normal. Her chest xray was normal. On 04 January 2004 the patients record reflects the following laboratory data:  hematocrit 30.5, WBC 1.9 and platelet of 131. Her neutrophils were 1100/mm3 and LDH was elevated at 1031. In addition her ANCA was reported as being  >1000. She was also evaluated by psychiatry during her stay at LRMC and was diagnosed with adjustment disorder with depression and anxiety.  On 11 January 2004, the client was aeromedical evacuated from overseas to the USA. Upon initial evaluation the client was found to have 1-2cm X 1cm anterior cervical chain lymphadenopathy, as well as 1 X 1 cm occipital lymphadenopathy. Her laboratory data revealed hemoglobin low at 9.4, hematocrit low at 27.6, WBCs low at 2.2 and platelet count of 125. Her complete blood chemistry demonstrated an multiple elevated values including  ALT 127, AST 72, LDH 786, and TSH 5.67.  She was seen and evaluated by hemo-oncology and a bone marrow biopsy was done which was reportedly within normal limits. She was also seen and evaluated by psychiatry. She was not diagnosed as having adjustment disorder as previously listed by team.  The client was prepared for discharge on 16 January 2004. Her final laboratory data included the following: hemoglobin 9.1, hematocrit 26.9, WBCs 2.7, RBC 3.16. It was decided to place the patient in a medical holding unit on neutropenic precautions until she is further evaluated 7 days after discharge.  The Vaccine Healthcare Center was asked to evaluate the patient to determine whether her clinical symptoms and presentation were related to her anthrax and smallpox vaccinations in October 2003.			Y		Y	21			Y	11/13/2003	11/25/2003	12	Glucose       100 77 80 BUN       16 10 10 Creat.       0.6 0.6 0.6 K+       3.7 4.1 4.3 NA+       141 141 140 CL-       107 106 106 CO2       28 27 28 CA    8.1   8.5 8.4 8.7 MG       2.2 2.2 2.2 Phos    2.3   4.0 3.4 3.5 ESR   40       ALT       127   AST       72   Alk Phos    35   59   LDH    280  1288 786 707 696 ANCA    814      ANA          TSH     1.89  5.67   T4       0.88   Homocystine       5.8   Methylmalonic       93   PT       13.2   PTT       30.9   INR       1.01   WBC 2.8 2.7 2.9 2.2  1.9 2.2 2.2  RBC      3.89 3.26 3.35  Hgb 11.2 11.2 10.1 10.1  11.1 9.4 9.7  Hct 31.3 31 26.8 31.1  33.3 27.6 28.4  Plat 78 90 126 146  141 125 126  Retic Count    0.8      Ferritin     491     Fe     45        TIBC     257     B12     756     Folate     9.5     Sickle cell    Negative      Mono          Parvo IGG       >1.20   Malaria     <1:20     EBV          CMV IGG     Negative  Positive   CMV IGM       Negative   Serum IGG       1370   Serum IGM       250     Bone Marrow Examination  Glucose 82 89 WBC 2.2 Granulopoiesis Orderly maturation BUN 12 14 RBC 3.35 Erythropoiesis Normoblastic maturation .       Creat. 0.6 0.6 Hgb 9.7 Megakaryopoiesis Present, maturing K+ 4.1 4.0 Hct 28.4 Lymphocytes Small, scattered, mature NA+ 141 140 MCV 84.6 Plasma Cells Conspicuous, mature CL- 108 108 MCH 29 Other No Carcinoma, granulomata or fibrosis CO2 25 26 MCHC 34.4 Touch Prep Support aspirate findings CA 8.7 8.3 RDW 13.4 Special Stains  LDH 592  Plat 126 Reticulin No increased fibrosis WBC 2.3 2.7 MPV 11.4 Iron Present, no ringed sideroblasts RBC 3.27 3.16 Retic 1.1 Final Diagnosis Normocellular marrow with trilineage maturation; no neoplastic or infiltrative process identified Hgb 9.4 9.1     Hct 27.6 26.9   Chest Xray 01/13/04 Normal Plat 153 149     Post-Hospitalization Laboratory Data 01/23/04                   NMCP  01/23/04                   NMCP Glucose 76 AST 23 BUN 14 ALT 42 Creat. 0.7 WBC 3.1 K+ 4.1 Hgb 9.4 NA+ 143 Hct 27.5 CL- 111 Plat 151 CO2 26 TSH, Sensitive 3.0 CA 8.5 T4, Free 0.92	MIL	MIL		None	None			1						1	Anorexia; Anxiety; Asthenia; Chills; Depression; Diarrhoea; Laboratory test abnormal; Lymphadenopathy; Nausea; Night sweats; Pancytopenia; Pharyngolaryngeal pain; Pyrexia; Somnolence; Vomiting	FLU3~EVANS VACCINES~765412~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0216699	02/19/2004	FL	46.0	46		F	02/19/2004	Flu shot given to me on 10/14/2003 by the nurse. My arm turned red and puffy. I called in and was told it would be fine. I also told them I was having severe pain and she stated it was my fibromyalgia acting up. So then I told her again later about it getting worse and she said to tell the doctor about it when I seen her. Doctor said that I should go back because she didn't specialize in it. So the doctor did ordered an xray at my request. It was normal. So she referred me. He stated it was fluid on my shoulder and gave me bextra to take for ten days and suggested therapy. I went to therapy and the lady said she couldn't do much to help me. I then told the doctor it was getting worse and she referred me to another doctor who stated it was tendonitis and brusitis and gave me a shot and told me to continue therapy. But yet the therapist contacted the rehab clinic to get a script for therapy and he never replied and or never sent them one either. So our insurance changed at the first of the year so I went to a new doctor. He said I have a frozen shoulder and sent me to another clinic. One doctor is the bone doctor. He told me to do therapy for eight weeks. That was it. The lady that does my therapy said she didn't know what he expected her to do. I went twice and then the neurologist said to do my therapy at home and gave me some pills for nerve damage and said he is sure the flu shot caused the problems. The pain management doctor gave me Daypro for the swelling and a tens unit. The daypro made some of the swelling go down but the tens unit made it worse. So she told me she is sure the flu shot caused the problem and that I needed to get me another opinion from a bone doctor. So I went to another doctor. Finally someone that could help with the pain. I am now having to pay for therapy three times a week, a membership for a gym, medicine and doctor bills all from getting a flu shot. And the worst of it all is I have only been getting an hour or two of sleep and I am left handed and she gave me the shot in my left arm. I had been looking for work and have had to turn down several jobs because of my arm not working and the severe pain I live with day in and day out. Ratterman did give me some pills for the pain and a shot to help. I finally got some sleep last night. Before today I couldn't even type.  Medical Record received on 4/7/2004 includes tenderness, shoulder capsulitis, and impingment syndrome.				Y				Y	N	10/14/2003	10/14/2003	0	xray came out ok, having MRI done on Tuesday February 24th. The doctors say it came from the flu shot. My arm was fine before I got the shot. Medical record received on 4/7/2004 includes sensory neuropathy and TSH elevated level.	PVT	UNK			levoxyl - hypothyroidism protonix - for stomach neurenton - beginning of carpal tunnel was in the best health I had been in a long time. I really felt great that day. I got a flu shot last year and didn't have any problems from it. But this time I had a problem within ten minutes of getting the shot. Medical record received 4/7/2004 includes headache syndrome, anemia, seasonal allergy, back pain, galactorrhea, neck pain, muscle spasm, IBS, esophogeal reflux, depression, chest trauma, obesity, and numbness in both arms.			1						1	Arthropathy; Bursitis; Fibromyalgia; Laboratory test abnormal; Nerve injury; Neuropathy; Pain; Swelling; Tenderness; Tendonitis	FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0216653	02/20/2004	PA	70.0	70		F		This is a 71 year old female died after a respiratory arrest secondary to aspiration while enrolled in RSV 11 vaccine study. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/17/02. The subject died 374 days post immunization on 10/26/03 after choking on some food and aspirating. She was intubated, but did not recover. The aspiration and respiratory arrest were reported by the investigator as unrelated to the study vaccine. Additional information received on 2/13/04. After several attempts, the investigator is unable to obtain a death certificate. The ER record received on 2/26/04 states syncope and cardiac arrest. The discharge summary received on 2/26/04 states cellulitis of R elbow, infected bursitis, and severe COPD.	Y	10/26/2003							N	10/17/2002	10/26/2003	374		UNK	UNK	Paxil; Klonopin; Risperdal; Glyburide; K-Dur; Prinivil; Norvasc; Pepcid; Imdur; Lasix; Glucophage; Lanoxin; Uniphyl; Albuterol		Emphysema; COPD; Chronic Ischemic Heart Disease; Hypertension; Diabetes. Information from the patient's previous SAE and hospitalizations. On November 7, 2002, the subject noticed a lump in her right breast 21 days post immunization and 96 days later was diagnosed with breast cancer. Subject had a mammogram and ultrasound. Pathology results showed infiltrating ductal carcinoma, class 4. There is no family history of breast cancer. Patient was not hospitalized. Event was assessed as life threatening. History- on home oxygen. Past surgical history: Hysterectomy, tonsillectomy and appendectomy. Allergies: Penicillin. First hospitalization occured 163 days post immunization on March 28, 2003. She had a right sentinel node axillary dissection and lumpectomy. On postoperative day #1, she complained of shortness of breath. Pulmonary was consulted. Her dressing were clean and dry. Her hemoglobin was stable. On postoperative day #2, her vital signs remained stable. Jackson-Pratt drains had minimal drainage. She was seen by the doctor and placed on Decadron. Post op complications included acuter exaberation COPD, bronchitis and metabolic encephalopathy. Subject recovered with residual effects and was discharged 7 days later on April 4, 2003. Second hospitalization occured 358 days post immunization on October 10, 2003 for cellulitis of her elbow and was discharged 6 days later on October 16, 2003.		200302775	1						1	Aspiration; Bursitis; Cardiac arrest; Cellulitis; Choking; Hypoxia; Lung disorder; Respiratory arrest; Syncope	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0216656	02/20/2004	CA	55.0	54		M	02/19/2004	Pt presented to MD with reddened throat, sore throat, and rash on back, hips and groin.  Pt also experiencing fatigue.  Symptoms have not resolved.  Pt never had a flu shot previously.				Y					N	10/23/2003	10/26/2004	369	NONE	OTH	OTH	Lipitor; Aspirin 81mg;	NONE	Hypercholesterolemia;			1						1	Erythema; Fatigue; Pharyngolaryngeal pain; Rash	FLU3~SANOFI PASTEUR~U1126AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0216714	02/23/2004	TX	0.63	0	.6	F		High fever per pediatrician. Stress could of caused strabismus to occur earlier. May or may not be related to shot.  Per annual follow up report surgery was requried in both eyes to tighten the muscles of her eyes. Her physican told us the high fever that was a reaction to the shot brought about a wandering eye.								Y	N	10/23/2003	11/15/2003	23		PVT	PVT		NONE	NONE			1						1	Eye disorder; Pyrexia; Strabismus	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0216722	02/23/2004	DC		21		M	02/12/2004	Fever (101), generalized aches									Y	02/11/2004	02/11/2004	0	NONE	MIL	MIL	PPD	NONE	NONE			1						1	Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~UNK~~~MENINGOCOCCAL (NO BRAND NAME)~1	USA		Influenza
0216738	02/24/2004	NY		5		F	02/03/2004	Patient developed clinical pneumonia 5 days after receiving Flumist. Diagnosed by private medical doctor 12/24/03. Prescription Zithromax for 5 days. Medical record states asthenia. msv									U	12/18/2003			Chest x-ray 1/2/04 (time of pulm. consultation) central interstitial markings are mildly permanent. There are areas of peribronchial cuffing.  Medical records states sinus bradicardia. msv	UNK	UNK			Chronic Cough, exertional dippner			1						1	Asthenia; Laboratory test abnormal; Pneumonia; Sinus bradycardia; Pneumonia; Unevaluable event	FLUN3~MEDIMMUNE VACCINES, INC.~400015P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500015P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0216739	02/24/2004	SC	52.0	52		F	01/28/2004	Administered Flumist to 4 children on 1-14-04. Children sneezed with administration- started having increased tightness in chest, and shortness of breath. Low grade fever headache, sore throat, nasal stuffiness on 1-17 to 1-19-04 was confined to bed. Went to doctor on 1-22-04 and felt like I was going to die. Started on antibiotics, inhalants and Predinisone.				Y					U	01/14/2004	01/15/2004	1	Chest x-ray 1-21-04.	UNK	UNK			Chronic obstructive pulmonary disease.			1						1	Chest discomfort; Dyspnoea; Headache; Malaise; Nasal congestion; Pharyngolaryngeal pain; Pyrexia; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~500101P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0216740	02/24/2004	SC	42.0	42		F	01/28/2004	Administered flu mist to me client in morning. By afternoon had bad headache. Sore throat. Low grade fever.									U	01/14/2004	01/14/2004	0		UNK	UNK			Unexplained persistent respiratory infection from 10/27/03 until 12/30/03. Treated with Emycin for 3 weeks.			1						1	Headache; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~50010P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216741	02/24/2004	IA	71.0	70		M	02/12/2004	Pt received a yearly influenza vaccination. Pt received this years flu shot at the pharmacy. Pt was taken to ER by ambulance. Death certificate states anaphylaxis, respiratory and cardiac arrest, influenza vaccination. Body released to funeral home no autopsy.	Y	10/22/2003							N	10/22/2003	10/22/2003	0		OTH	OTH			COPD, HTN, ASHD		IA03016	1						1	Anaphylactic reaction; Cardiac arrest; Respiratory arrest	FLU3~SANOFI PASTEUR~U1079AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0216747	02/24/2004	IL	33.0	33		M	09/22/2004	From initial info received on 2/18/04 from a nurse practitioner, regarding an adverse event, it was reported that a 33 year old male pt received Fluzone (u1137HA), administered IM in the left deltoid on 10/29/03. During December 2003 (exact date of onset is unknown) the pt experienced pain in his arms and legs, and extreme fatigue. The pt was hospitalized in December. The pt partially recovered from this event and was able to go back to work in January 2004. From additional information received on 01Jun04 from a health care professional it was reported, No additional information at this time. From additional information received on 21Sep04 from a registered nurse, it was reported that there is no additional information at this time. It was not reported whether the pt recovered from these events. No further information is anticipated, this case is considered closed. Follow up 01/06/05: Medical Assessment: File to be completed.					Y				U	10/29/2003	12/12/2003	44		OTH	OTH		NONE	From additional information received on 21Sep04, it was reported that the pt was not taking any other medications at the time of vaccination.		200400543	1						1	Fatigue; Pain	FLU3~SANOFI PASTEUR~U1137HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0216748	02/24/2004	CA	49.0	49		F	02/19/2004	This case was initially reported from the pt on 11/25/03 and was considered non-serious. From additional info received from the responsible physician on 2/13/04 this case has been upgraded to serious. No seriousness criteria was reported. Based upon medical judgment this case is considered serious: medically significant event (OMIC). From initial info received on 11/25/03 from the pt regarding an adverse event, it was reported that the 49 year old female pt received a dose of Fluzone (U1122AA), administered in the left arm on 11/10/03. Two days later, on 11/12/03, the pt developed SOB, rash and swelling of her eyes. The pt took Benadryl, prednisone, and used an Epipen to treat the symptoms. The pt has a history of asthma. Her recovery status is currently unknown. From additional info received on 2/13/04 from the responsible physician, it was reported that the pt developed erythema multiforme, which lasted almost 2 months. She then experienced mild recurrent rash relapses. Additionally, the injection site would become red and tender with rash flare-ups. At the time of this report, the erythema multiforme was slowly subsiding, however, she continued to experience the recurrent mild rash and was still on antihistamines. Her medications included Allegra 120mg daily, Singulair 10mg daily and Advair as needed. The pt has not recovered from these adverse events.				Y					N	11/10/2003	11/12/2003	2		PVT	PVT	Combivert, Pepcid, unspecified inhaler	NONE	Athma, allergic to sulfa, tetracycline and Flozil.		200303261	1						1	Dyspnoea; Erythema multiforme; Eye oedema; Injection site erythema; Injection site pain; Injection site rash; Rash	FLU3~SANOFI PASTEUR~U1122AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0216749	02/24/2004	VA	51.0			F	02/09/1998	51 year old white female admitted with a chief complain of fever after receiving the flu vaccine 10/27/93. Patient had a fever (103.4F) and was found to be hypotensive in the ER. Patient's past medical history includes End-stage cirrhosis (hepatitis B-C), diabetes, asthma, and portal hypertension. Patient also complains of intermittent nausea vomiting and diarrhea for 3 weeks, increased dyspnea on exertion and orthopnea. Patient treat with Ceftriaxone empirically. Chest x-ray no definite infiltrate. Bleeding of left custophrachic angle consistent with left pleural effusion- no change from previous study. Blood culture negative,  urine analysis equal to many bacteria. Patient became afebrile 10/30/98 and discharged.									U	10/27/1997	10/28/1997	1	10/28/97:  5Ci= 64; Co2 (8 (low) Na=133 (low)- all other came 7 values within normal limits; WBC= 12.0 (High); Segs = 72; Blood Cultures- negative; U/A-many Bacteria. 10/30/97: WBC=503.	UNK	UNK	Medications upon admission: Propaudol 40 Mg PO BID, Diabetes 2.5 mg PO BID, Spironolestone 300 mg PO Phenerzar 25 mg every 4 hours as needed nausea, Prilosec 20 mg. (start 10/27/97)		End stage hepatic function- waiting visit for 1 more transplant. minus smoking minus Etiom. Allergies no known allergies, Hex: of left pleural effusion.			1						1	Diarrhoea; Dyspnoea; Hypotension; Nausea; Orthopnoea; Pleural effusion; Pyrexia; Urine analysis abnormal; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0216751	02/24/2004		68.0			U		Hypersensitivity reaction to flu vaccine.  Action: admit to ER, diphenkyloxima and cephalexin were prescribed.				Y					U		12/15/1997			UNK	UNK	Mangime;					1						1	Hypersensitivity	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0216752	02/24/2004	CT	51.0	51		F	11/01/1997	AM after flu shot both my husband and I woke with a headache with stayed with me all day even with use of Ibuprofen. Within 24 hours tickle cough started with chest tightness. By weekend fever, chills, coughing increased. Chest cough very painful. Don't have asthma but started using and proventil inhaler. Called Center for Disease Control they recommended see doctor. Doctor said Bronchitis and watch/call if worse. Now 10 days later, still coughing, this remained all respiratory. Very thick mucous coughed up, very stubborn spells of coughing; still present and very hard to stop coughing spasm. Taking antibiotic drug to loosen tightness and this still persists.				Y					U	10/21/1997	10/22/1997	1		UNK	UNK			Before this shot I was a very healthy individual. Exercised each day, good diet, sleep pattern good- I work in a doctors office exposed to a lot each day. The follow people I know also experienced suspect adverse effects after the flu shot. My grandson, age 8 who has asthma. My dad who is 83 (pretty healthy active). My female cousin who was healthy till the shot works in doctors office and had symptoms that matched mine. She received her shot 25 miles away from where I did. My best friends son said when flu shot given in his barracks many became ill.			1						1	Bronchitis; Chest discomfort; Chest pain; Chills; Cough; Headache; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0216753	02/24/2004	MD				M	12/12/1997	Numbness, tingling, drooping left side of face. Bell's Palsy									U		11/17/1997		HIV, Anti Hepatitis B surface, ESR, Lyme disease antibody.	UNK	UNK						1						1	Facial palsy; HIV infection; Hypoaesthesia; Paraesthesia	FLU3~PFIZER\WYETH~4978191~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0216754	02/24/2004	CA	18.0	18		F	12/17/2003	Patient felt slightly nauseous and light headed approximately 1 minute after administration of Flumist- asked patient to stay seated for approximately 5 minutes, had patient drink fluid. After approximately 2 minutes, patient still light headed. Had patient lay on ground supporting head and elevating legs. After approximately 5 minutes patient felt fine. Had patient wait approximately 10 more minutes and patient was ok.									Y	12/17/2003	12/17/2003	0	UNK	OTH	PVT	UNK	UNK	UNK			1						1	Dizziness; Nausea	FLUN3~MEDIMMUNE VACCINES, INC.~500031P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216755	02/24/2004	IN	58.0	58		F	02/03/2004	Discomfort, decreased movement of extremity. Doctor care and physical therapy analgesics.				Y					U	10/23/2003	10/27/2003	4		PUB	PVT						1						1	Discomfort; Hypokinesia	FLU3~EVANS VACCINES~765875~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0216756	02/24/2004	IN	40.0	40		F	02/17/2004	Discomfort. Increased discomfort with movement home remedies of ice/heat only analgesics.									U	10/20/2003	01/14/2004	86		PUB	PVT						1						1	Discomfort; Hypokinesia; Pain	FLU3~EVANS VACCINES~765875~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0216757	02/24/2004	IN	47.0	47		F	02/17/2004	Discomfort, increased discomfort with movement.  MD care and physical therapy; analgesics.				Y					U	10/23/2004	02/03/2004		UNK	PUB	PVT	NONE	NONE	NONE			1						1	Discomfort	FLU3~EVANS VACCINES~765875~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0216758	02/24/2004	MD	24.0	24		M	02/19/2004	Within 1-2 hours following receipt of vaccine, developed pruritis and urticaria-possible type 1, IgE-medicated hypersensitivity reaction. See clinical summary-skin testing will be completed in 03/04. Follow-up: Patient was skin tested for the flu vaccine. He had a positive intradermal skin test to 1:10 dilution of influenza vaccine.				Y					Y	01/23/2004	01/23/2004	0	NONE	MIL	MIL	Sudafed (last dose was taken 01/22/04)	Recovering from URI;	3 GSW to back, right side arm arm during OIF with subsequent hospitalizations and surgeries.  Tonsillectomy at age 20; Surgeries following GSWs.			1						1	Hypersensitivity; Rash pruritic; Urticaria	FLU3~EVANS VACCINES~765753~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0216759	02/24/2004	CA	70.0	70		F	02/02/2004	Pt developed achy muscle, flu-like symptoms, fever and weakness in arm and legs.  She was treated with Neurontin and vaslin and vitamin B6, Tylenol.				Y					N	09/30/2003	10/01/2003	1	NONE	PVT	PUB	Coyaar; Mevacor; Prilosec; Amytryostylene;Muscalcin; Vanceril; Astrovent; Pepcid; Catapres; Neuronitin; Cipro;	NONE	Allergic rhinitis; PCN; all sulfa drugs; Valium; Codeine; Propuloid; ASA; Estrogen; Zaroxolyn; Procardio; Prednisone; Thephylline;			1						1	Asthenia; Influenza like illness; Pain; Pyrexia; Influenza like illness; Muscular weakness; Myalgia; Pyrexia; Urinary tract infection	FLU3~SANOFI PASTEUR~U1260AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1260AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0216760	02/24/2004	IL	31.0	31		F	12/09/2003	Noticed pain immediately upon injection which has progressed to include shoulder left.  Left hand joints also achy.  No signs of infection, no numbness or tingling.  So hard to raise arm above shoulder level.  Had not prescribed 11/21 ice and anti-inflammation worsened.  Has not seen MD. Unable to reach for further follow up.									U	10/23/2003	10/23/2003	0	NONE	OTH	PVT	NONE	NONE	Codeine Allergy;			1						1	Arthralgia; Injection site pain; Pain	FLU3~SANOFI PASTEUR~U1077AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0216761	02/24/2004	IL	50.0	50		F	11/06/2003	2 inch area in diameter around the injection site of redness and swelling, lasting approximately 5 days.  Prescription with ice.  History: 1st flu vaccine: 4inch area of redness and swelling lasting several days, done in 2000.									Y	10/14/2003	10/14/2003	0	NONE	OTH	PVT	NONE	NONE	Hayfever; Pineapple; Shellfish allergies;	Redness and swelling~Influenza (Seasonal) (no brand name)~1~47.00~In Patient		1						1	Injection site erythema; Injection site oedema; Vaccine positive rechallenge	FLU3~EVANS VACCINES~765485~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0216762	02/24/2004	TX	47.0	47		F	11/06/2003	Itchy rash of small red spots first noticed PM of day after vaccine.  Spread to neck, chest and other arm (vaccine and initial rash right arm) by 3 days after shot, prescribed with oral and topical Benadryl; 11/06 rash almost gone.									U	10/31/2003	11/01/2003	1	NONE	OTH	PVT	Lamsil;	Prescribed toenail fungus;	Seasonal allergies;			1						1	Erythema; Rash; Rash pruritic	FLU3~SANOFI PASTEUR~U1253AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0216763	02/24/2004	WI	3.5	3		M	02/09/2004	Pt received vaccine at 17:00.  Around 02:00, pt experienced possible emesis. Following AM, approximately 06:00-07:00 emesis and several times.  Pt experienced emesis again1 time 2 days later.  No fever, aches, headache, or any other symptoms apart from anorexia and emesis.									Y	01/27/2004	01/28/2004	1	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Anorexia; Vomiting	FLU3~SANOFI PASTEUR~U1122AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0216764	02/24/2004	CA	65.0	65		F	02/14/2004	Severe pain in upper right quadrant extending to spine upon going to a sitting position or turning.  Pain not so bad when walking.  Started 2 days after flu vaccine.  Feeling of fullness like a balloon inside.  2 days earlier rash, possible shingles.				Y					N	11/05/2003	11/07/2003	2	CT scan of pelvis; abdominal area;	OTH	PVT	Given medication for shingles, pain medication;	NONE	Coming off crutches after broken leg;	I did not have flu shot since in my 20's when I had severe flu symptoms following a flu shot.~Influenza (Seasonal) (no brand nam		1						1	Abdominal distension; Herpes zoster; Pain; Rash; Abdominal distension; Abdominal pain upper; Herpes zoster	FLU3~SANOFI PASTEUR~U1256AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1256AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0216808	02/24/2004	SC	52.0	52		M	02/24/2004	Onset of needle type pain in muscles, pain in left arm, shoulder, and back with severe twitching in shoulder, legs, arms and hands.  generalized weakness especially when raising arms. Started approximately 2 weeks after flu and tetanus vaccines which were administered on 11/24/2003.  Has received flu and tetanus vaccinations in the past without incident.  Patient is currently followed by 3 PMDs and a neurologist. *Denies history of GBS.  *Patient refused to sign consent for health department to obtain records from PMDs or neurologist.									U	11/24/2003	12/08/2003	14	NONE.  Patient refused to sign consent for health department to obtain records from PMDs or neurologist	PUB	PUB	None identified	Denied at time of vaccination	Denied at time of vaccination		SC0358	1						1	Asthenia; Muscle twitching; Myalgia; Pain	FLU3~SANOFI PASTEUR~U1291AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TTOX~SANOFI PASTEUR~U1000AA~3~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0216809	02/24/2004	SC	23.0	24		M	02/24/2004	Nurse administered 2 shots in left arm ( flu and HepA), then 1 shot in right arm (HepB).  Patient jumped up and said I feel hot. Nurse assisted patient back to chair where patient was sweaty, pale and complained of feeling faint.  Stated he had not eaten lunch.  Given Coca-cola and cool cloth.  Was monitored for 25 minutes.  Friend drove patient home.									Y	02/03/2004	02/03/2004	0	NONE	PUB	PUB	NONE	NONE	NONE		SC0405	1						1	Dizziness; Feeling hot; Hyperhidrosis; Pallor	FLU3~EVANS VACCINES~766321~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~5390A4~2~IM~RA~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~786A4~1~IM~LA~HEP A (HAVRIX)~1	USA		Influenza
0216810	02/24/2004	FL	0.5	0	.5	M	02/24/2004	mom here with child who states symptoms started 02/18/04, 1 day after immunizations were given. Left lat thigh very hot and swollen. Very fussy and was examined earlier by the pulmonologist who referred mom to bring patient here. Examined futher by an ARNP, who instructed mom to give Tylenol gtts prn and apply cool compresses. If symptoms worsen return to clinic or go to emergency dep't.				Y					Y	02/17/2004	02/18/2004	1	n/a	PUB	PUB	Pulmicort Respules every day	none	Asthma History of bronchiolitis.			1						1	Injection site swelling; Injection site warmth; Irritability	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~21918A9~2~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1228BA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1152N~3~IM~LL~HIB (PEDVAXHIB)~1	USA	Emergency room visit	Influenza
0216811	02/24/2004	KY	0.5	0	.6	M	02/12/2004	Gave FluVac at 8:30 on 2/11/04.  On 2/12/04 at 8:15 am mother of patient called.  Noticed bumps on upper extremities 2/11/04, slowly progressed to cover entire body.  No difficulty breathing, no fever, no irritablility.  Advised to call pediatrician.									Y	02/11/2004	02/11/2004	0		PUB	PUB	Albuterol	none	Asthma		KY2004011	1						1	Rash	FLU3~SANOFI PASTEUR~U1131AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0216817	02/24/2004	CA	22.0			M	02/24/2004	SWOLLEN RT ARM REACTION FROM FLU VACCINE				Y					U					MIL	MIL						1						1	Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0214852	02/25/2004		39.0			F	02/18/2004	Information has been received from a health professional and from the Center for Disease Control concerning a 39 year old female with a history of hiatus hernia, gastritis, migraines, osteoarthritis of hte left knee, and hyperlipidaemia. The pt denied any history of valvular heart diseasee, hyypertention, cerebrovascular accident, carotid artery disease, anemia, asthma, cancer, diabetes, eczema, chronic skin disorders, gallbladder disease, hepatitis, or thyroid disease. There were no concurrent diseases. On 1/29/03, the pt was vaccinated IM with a second dose of hep A virus vaccine inactivated. Suspect therapy that day included a first dose of hep B virus vaccine administered IM, a first dose of yellow fever administered SC, a second dose of Menomune, a first dose of anthrax vaccine SC, a first dose of smallpox vaccine administered ID, a fifth dose of influenza virus vaccine administered IM. Concomitant therapy included vitamin E. One week after receiving the vaccinations, on approximately 2/5/03, the pt started to experience chest receiving the vaccinations, on approximately 2/5/03, the pt started to experience chest pain. The pt also reported experiencing similar chest pain the second week of February. On 3/4/03, the pt also received a second dose of hep B virus vaccine administered IM and a dose of anthrax vaccine administered SC. At the end of March 2003, the pt again experienced chest pain. She did not seek medical care until the chest pain episodes returned on 5/20/03 while she was deployed. The pt was reportedly diagnosed with a non-Q wave myocardial infarction. Diagnostic tests revealed an elevated CPK (peak of 317) and an elevated troponin. Other lab data on 5/21/03 included: glucose 94; BUN 8; creatinine 0.9; Na 137; K 4.1; Cl 107; CO2 21; CPK 138; and second CPK 317. The pt was medically evacuated to a medical center. While at the center, her cardiac enzymes showed to be abnormal with a peak CK of 98 (normal), elevated CK-MB of 12, and an elevated troponin of 21. A cardiac catheterization on 5/23/03 revealed a right dominant coronary system with branch vessel disease (significant disease involving a very small branch of the circumflex system). The pt had a very small first obtuse marginal branch that had a 90% ostial lesion in it. She also had a 60% ostial moderate size diagonal branch lesion. Normal overall LV systolic function without segmental wall motion abnormalities or mitral regurgitation. Given the relatively small size of the affected vessel, the pt was not considered a good candidate for revascularization. Given the findings and continuous chest discomfort, the pt remained in the ICU and was placed on a full Bruce treadmill test. She did not develop any ischemic ECG changes on the treadmill. The pt's physicians did not feel that her chest pain was cardiac related. A PA/ lateral chest x-ray revealed a blunt right hemidiaphragm consistent with a small effusion. The pt was hospitalized for three days. A repeat chest x-ray, obtained 5 days later, showed that the effusion had resolved. An abdominal ultrasound was performed, which was unremarkable other than a non distended gallbladder. A gastroenterology consult was obtained, and an esophagogastroduodenoscopy was performed, which revealed a small erosion on the antral portion of the stomach, but was not felt to be causal of the chest pain. She was placed empirically on Aciphex. While at the center, a psychiatry consult was obtained to evaluate the pt's eating habits, and she was diagnosed with anorexia nervosa of a restrictive type. No medications were started for this. She stayed at the center for 2-3 weeks before being transferred to another center for further evaluation. Her discharge medications included Lopressor 25mg twice daily, Plavix 75mg daily, Aciphex 20mg twice daily, and simvastatin. On 6/6/03, during a cardilogy evaluation, her EKG showed NSR, NL EKG GXT-Thall obtained on 6/9/03 showed moderate to severe diminished activity in the anterolateral wall after 12:56 minutes, which improves with rest. EF 55%. TTE 6/10/03: normal echography with EF 60-65%. The physician indicated that although her MPS showed ischemia in the anterolateral wall, her ability to exercise for 12:55 minutes without cardiac symptoms translates in a good prognosis. He also reported that the pt's chest pain was non-cardiac, but most likely musculoskeletal in nature and referred her to internal medicine. It was thought to likely be costochondritis and she was referred for a PA chest x-ray, which the records indicated were normal. At the time of vaccination, the pt also took vitamin E. After her myocardial infarction, she started Librax capsules daily for a hiatal hernia, rabeprazole 20mg twice daily, atenolol daily, Davocet-N 100mg every eight hours as needed for pain, nitroglycerin spray as needed for chest pain, and an Epi-pen for emergency use. Reportedly, the pt did not recover from these events. The following diagnostic lab data were obtained. On 6/4/03, a lung ventilation-perfusion scan exam showed an area of relative photopenia corresponding in location to the oblique fissure of the left lung; relative widening of this area of photopenia in the mid-lung; additionally, there was mild, relatively decreased perfusion to the right lung apex; the mediastinal and cardiac silhouettes were normal in appearance; the ventilation images showed matching, though less prominent, areas of relative photopenia in the oblique fissure of the left lung an in the right apex; a moderate amount of gastrointestinal activity was observed in the ventilation images; exam revealed matching, non-segmental perfusion and ventilation defects with a pattern suggestive of fluid in the left oblique fissure consistent with a low probability for pulmonary embolism. On 6/6/03 at 9:58, a Coll+HIB-1 AB: negative, Coll-G6PD: normal. On 6/9/03 at 7:08, a myocardial perfusion (spect) multi-ST exam showed LVEF of 55% with normal wall motion; under myocardial stress conditions, there was a moderate to severe diminished activity about the interolateral wall, which improved in the resting conditions; this was in the distribution of the first diagonal vessel; the exam revealed an abnormal myocardial perfusion study with findings consistent with ischemia in the anterolateral distribution consistent with first diagonal obstructive vessel. On 6/11/03, a chest x-ray showed normal lung volumes and her lungs were clear; cardiomediastinal silhouette and pulmonary vasculature were normal; osseous structures were unremarkable; no acute disease found. On 6/11/03 at 13:28, cholesterol was elevated at 311 (50-200) mg/dl, LDL (direct) was elevated at 211 (1-129) mg/dl, VLDL was at 34 and total cholesterol/HDL at 4.71. On 7/5/03 at 8:40, albumin was low at 3.5L (3.9-5.0) g/dL. On 8/12/03, an echocardiogram showed a normal echo doppler; overall left ventricular function was normal with an estimated EF of 60-65%; no pericardial effusion was seen no valvular or structural abnormalities were noted; there were no intracardiac shunts; doppler flows were normal. On 8/14/03, myocardial imaging showed a negative stress test: no evidence of ischemia, normal wall motion, and normal EF of 67%. On 10/1/03, an upper GI series showed mild to moderate gastroesophageal reflux and a mild to moderate hiatal hernia; findings were suggestive of at least gastritis; recommended treatment included treadmill exercise with rest and stress/ cardiolyte. A gastroenterology consult was obtained, and a esophagogastroduodenoscopy was performed, which revealed a small erosion on the antral portion of the stomach. Info received on 2/5/03 was received which pertained to events that occurred 48 days after vaccination with hep A virus vaccine. This info contained the following adverse experiences: small effusion and anorexia nervosa. Chest pain and myocardial infarction were considered to be lifethreatening and to be other important medical events (OMIC). Additional info is expected.			Y		Y				N	01/29/2003	02/05/2003	7	Diagnostic tests revealed an elevated CPK (peak of 317) and an elevated troponin. Other lab data on 5/21/03 included: glucose 94; BUN 8; creatinine 0.9; Na 137; K 4.1; Cl 107; CO2 21; CPK 138; and second CPK 317. The pt was medically evacuated to a medical center. While at the center, her cardiac enzymes showed to be abnormal with a peak CK of 98 (normal), elevated CK-MB of 12, and an elevated troponin of 21. A cardiac catheterization on 5/23/03 revealed a right dominant coronary system with branch vessel disease (significant disease involving a very small branch of the circumflex system). The pt had a very small first obtuse marginal branch that had a 90% ostial lesion in it. She also had a 60% ostial moderate size diagonal branch lesion. Normal overall LV systolic function without segmental wall motion abnormalities or mitral regurgitation. She did not develop any ischemic ECG changes on the treadmill. A PA/ lateral chest x-ray revealed a blunt right hemidiaphragm consistent with a small effusion. An abdominal ultrasound was performed, which was unremarkable other than a non distended gallbladder. A gastroenterology consult was obtained, and an esophagogastroduodenoscopy was performed, which revealed a small erosion on the antral portion of the stomach, but was not felt to be causal of the chest pain. On 6/6/03, during a cardilogy evaluation, her EKG showed NSR, NL EKG GXT-Thall obtained on 6/9/03 showed moderate to severe diminished activity in the anterolateral wall after 12:56 minutes, which improves with rest. EF 55%. TTE 6/10/03: normal echography with EF 60-65%. The physician indicated that although her MPS showed ischemia in the anterolateral wall, her ability to exercise for 12:55 minutes without cardiac symptoms translates in a good prognosis. PA chest x-ray, which the records indicated were normal. On 6/4/03, a lung ventilation-perfusion scan exam showed an area of relative photopenia corresponding in location to the oblique fissure of the left lung; relative widening of this area of photopenia in the mid-lung; additionally, there was mild, relatively decreased perfusion to the right lung apex; the mediastinal and cardiac silhouettes were normal in appearance; the ventilation images showed matching, though less prominent, areas of relative photopenia in the oblique fissure of the left lung an in the right apex; a moderate amount of gastrointestinal activity was observed in the ventilation images; exam revealed matching, non-segmental perfusion and ventilation defects with a pattern suggestive of fluid in the left oblique fissure consistent with a low probability for pulmonary embolism. On 6/6/03 at 9:58, a Coll+HIB-1 AB: negative, Coll-G6PD: normal. On 6/9/03 at 7:08, a myocardial perfusion (spect) multi-ST exam showed LVEF of 55% with normal wall motion; under myocardial stress conditions, there was a moderate to severe diminished activity about the interolateral wall, which improved in the resting conditions; this was in the distribution of the first diagonal vessel; the exam revealed an abnormal myocardial perfusion study with findings consistent with ischemia in the anterolateral distribution consistent with first diagonal obstructive vessel. On 6/11/03, a chest x-ray showed normal lung volumes and her lungs were clear; cardiomediastinal silhouette and pulmonary vasculature were normal; osseous structures were unremarkable; no acute disease found. On 6/11/03 at 13:28, cholesterol was elevated at 311 (50-200) mg/dl, LDL (direct) was elevated at 211 (1-129) mg/dl, VLDL was at 34 and total cholesterol/HDL at 4.71. On 7/5/03 at 8:40, albumin was low at 3.5L (3.9-5.0) g/dL. On 8/12/03, an echocardiogram showed a normal echo doppler; overall left ventricular function was normal with an estimated EF of 60-65%; no pericardial effusion was seen no valvular or structural abnormalities were noted; there were no intracardiac shunts; doppler flows were normal. On 8/14/03, myocardial imaging showed a negative stress test: no evidence of ischemia, normal wall motion, and normal EF of 67%. On 10/1/03, an upper GI series showed mild to moderate gastroesophageal reflux and a mild to moderate hiatal hernia; findings were suggestive of at least gastritis; recommended treatment included treadmill exercise with rest and stress/ cardiolyte. A gastroenterology consult was obtained, and a esophagogastroduodenoscopy was performed, which revealed a small erosion on the antral portion of the stomach. Info received on 2/5/03 was received which pertained to events that occurred 48 days after vaccination with hep A virus vaccine.	OTH	OTH	Vitamin E		Hiatus hernia; Gastritis; Migraine; Osteoarthritis; Hyperlipidemia		WAES0402USA01064	1						2	Chest pain; Gastrooesophageal reflux disease; Laboratory test abnormal; Myocardial infarction; Skin ulcer; Anorexia nervosa; Chest pain; Laboratory test abnormal; Myocardial infarction; Pleural effusion; Anorexia nervosa; Blood creatine phosphokinase increased; Chest discomfort; Chest pain; Myocardial infarction	ANTH~EMERGENT BIOSOLUTIONS~FAV073~1~SC~UN~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~Unknown~5~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~Unknown~1~IM~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~Unknown~2~IM~UN~HEP A (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~Unknown~2~SC~UN~MENINGOCOCCAL (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4020071~1~ID~UN~SMALLPOX (DRYVAX)~1|YF~UNKNOWN MANUFACTURER~Unknown~1~SC~UN~YELLOW FEVER (NO BRAND NAME)~1|ANTH~EMERGENT BIOSOLUTIONS~FAV073~1~SC~UN~ANTHRAX (BIOTHRAX)~2|FLUX~UNKNOWN MANUFACTURER~~5~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEPA~UNKNOWN MANUFACTURER~~2~IM~UN~HEP A (NO BRAND NAME)~2|MEN~SANOFI PASTEUR~~2~SC~~MENINGOCOCCAL (MENOMUNE)~2|SMALL~PFIZER\WYETH~4020071~1~ID~UN~SMALLPOX (DRYVAX)~2|YF~SANOFI PASTEUR~~1~SC~~YELLOW FEVER (YF-VAX)~2|ANTH~EMERGENT BIOSOLUTIONS~FAV093~1~SC~UN~ANTHRAX (BIOTHRAX)~3|FLUX~UNKNOWN MANUFACTURER~~5~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|HEP~UNKNOWN MANUFACTURER~~1~IM~UN~HEP B (NO BRAND NAME)~3|HEPA~UNKNOWN MANUFACTURER~~2~IM~UN~HEP A (NO BRAND NAME)~3|MEN~SANOFI PASTEUR~~2~SC~~MENINGOCOCCAL (MENOMUNE)~3|SMALL~PFIZER\WYETH~4020071~1~ID~UN~SMALLPOX (DRYVAX)~3|YF~SANOFI PASTEUR~~1~SC~~YELLOW FEVER (YF-VAX)~3	USA	Life Threatening,Hospitalisation	Influenza
0215910	02/25/2004	VA	12.0	12		F	02/13/2004	This report of wheezing is being submitted in an expedited time frame as requested by the FDA.  Follow-up information received provided the pt's date of birth, change in pt's last name, and vaccine lot number. Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal solution (frozen)) was received from a nurse regarding her 12 year old daughter who developed wheezing.  At 12 years of age, the pt received a dose on 12/19/03.  The pt had no relevant medical history.  She had no history of asthma or wheezing.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/19/03.  Dose regimen was 1 dose (intranasal).  Pt was not taking concomitant therapy.  On 12/19/03, the evening of vaccination, the pt began wheezing (wheezing).  She was treated with Ventolin (salbutamol) nebulizations and an unspecified steroid inhaler.  As of 01/16/04, her symptoms presisted and treatment continued.  No additional information was available at the date of this report.									U	12/19/2003	12/19/2003	0	UNK	OTH	OTH	NONE	NONE	UNK		HQWYE440416JAN04	1						2	Wheezing; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500002P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0216824	02/25/2004	CA	4.0	4		F	02/24/2004	R deltoid area and arm red and swollen and fever, pt seen by Dr given Motrin and Tylenol. Pt given instructions to RTL if worse, fever increase mother took child to ED, admitted with antibiotics and released next day.					Y	1			Y	02/19/2004	02/19/2004	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Erythema; Oedema peripheral; Pyrexia	DTAP~SANOFI PASTEUR~U0997DA~5~~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1142AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W1156~4~~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0807N~2~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Hospitalisation	Influenza
0216825	02/25/2004	WI	49.0	49		M	02/23/2004	Acute demyelinating poly neuropathy-GBS vs CIDP. The medical record received on 3/5/04 states Guillain-Barre, chronic neuropathy, fatigue, numbness, tingling of hands, low back pain, fever, weak in legs, and facial paresthesias.				Y					N	11/19/2003	11/29/2003	10	EMC/NCV studies; EMG shows conduction depression	PUB	OTH	NONE	NONE	L3/4 disc pain, lyme disease, meniere's, Raynaud's			1						1	Back pain; Fatigue; Hypoaesthesia; Muscular weakness; Neuropathy; Paraesthesia; Pyrexia	FLU3~SANOFI PASTEUR~U1190AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0216826	02/25/2004	NY	14.0	1	.5	M	02/24/2003	2 days status post vaccines child refused to ambulate not seen.  3 days status post vaccine ambulating.  4 days status post vaccine developed rash d/w erythema multiforme.				Y					U	02/18/2004	02/20/2004	2		PVT	PVT	NONE	NONE	NONE			1						1	Erythema multiforme; Rash	DTAP~SANOFI PASTEUR~C1612AA~4~IM~~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U11496A~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE143AA~4~IM~~HIB (ACTHIB)~1	USA	Emergency room visit	Influenza
0216837	02/25/2004	GA	3.0	3		F	02/19/2004	This information was considered medically important (OMIC). Information regarding Flumist nasal solution was received from a consumer regarding a 3 year old who developed the flu, pneumonia in the right lung, and vomiting, following exposure to her mother who received a dose of Flumist on 12/15/03. The reporter indicated that the patient has no significant medical history. The patient received a flu shot one week prior to the mother receiving a dose of Flumist on 12/15/03. Patient was not taking concomitant therapy. The child developed the flu several days after her mother received a dose of Flumost on 12/15/03. On 12/18/03, the child began feeling lethargic and sleeping during the day. On 12/22/03, the child developed pneumonia in her right lung and was prescribed an unspecified dose of amoxicillin for 10 days. She developed a fever up to 105 degrees F and the pediatrician was notified. The mother reported that the child developed vomiting several times due to the high fever. The fever was treated with Motrin alternating with acetaminophen as well as putting her in a tub of water to lower the fever. Her fever did not break until after 12/25/03. The mother indicated that cultures were not performed. The symptoms persisted for two weeks. No additional information was available at the time of this report. Follow up on 06/08/04 states: On 12/15/04, during the first twelve hours after the mother received Flumist, the child became clingy. On 12/18/03, the child began feeling lethargic and sleeping during the day, and subsequently developed the flu (influenza). On 12/22/03, the child developed pneumonia in her right lung (lobar pneumonia) and was prescribed an unspecified dose of amoxicillin for 10days. She developed a fever up to 105 deg F and the pediatrician was notified. The mother reported that the child developed vomiting several times due to the high fever. The fever was treated with MOtrin alternating with Tylenol as well as putting her in a tub of water to lower the fever. Her fever did not break until after 12/25/03. The mother indicated that cultures were not performed. After two weeks, the child completely recovered. The mother noted that the child did not come in contact with anyone else who had the flu. Follow up informaiton received from the child's pediatrician provided laboratory test results and additional vaccination details:									Y	12/15/2003	12/22/2003	7	WBC: 4.5 K/uL	PVT	PVT	NONE	UNK	UNK		HQWYE931111FEB04	1						1	Infection transmission via personal contact; Influenza; Pneumonia; Pyrexia; Somnolence; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0216845	02/25/2004	VT	89.0			M	02/16/2004	Was given a flu shot have chills and fever ever since. Medical record states anxiety, depression. msv								Y	U		11/01/2002			UNK	UNK	Saw palmetto; Glucosamine; Chondrotin sulfates		Back injury; Colorectal cancer; Fusion C5-6, incision bladder; Colon canser;			1						1	Anxiety; Chills; Depression; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0216847	02/25/2004	IL	26.0	26		M	11/17/2003	Developed severe rash all over body.  First noticed 2 days after vaccine.  Saw MD who felt it was a reaction to the vaccine and prescribed Claritin.  Within 2 weeks the rash was gone.									Y	10/07/2003	10/09/2003	2	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Rash	FLU3~EVANS VACCINES~765485~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0216848	02/25/2004	FL	4.0	4		M	02/13/2004	Pt had one spell of some confusion in middle of night with no clear tonic or clonic activity, has rare headaches.									Y	12/31/2003	01/07/2004	7	Abnormal EEG: some temporal sharps;	PVT	PUB	NONE	Sinusitis;	Autistic-like features with pervasive developmental delay; Hydrocele; vur;			1						1	Confusional state; Electroencephalogram abnormal; Headache	FLU3~SANOFI PASTEUR~766053~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W1582~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0608N~2~SC~LA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA		Influenza
0216849	02/25/2004	IL		56		F	10/31/2003	Noticed itching and blotchy skin afternoon following day of injection. Prescribed with Benadryl 10/30/03. 10/31/03 spoke with pt, redness much better itching nearly gone.  Area of rash 6 inches in diameter at worst point.									U	10/29/2003	10/30/2003	1	NONE	OTH	PVT	Celebrex; HRT;	NONE	Arthritis;			1						1	Injection site erythema; Pruritus; Rash macular	FLU3~EVANS VACCINES~765499~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0216850	02/25/2004	GA	1.5	1	.5	M	02/18/2004	2/13/04 Mom called our office-Had 2-3 small raised bumps on his back. No fever. 2/16/04 seen in office approximately 50 bumps abdomen, (sides and axilla on the Left). Playful. Afebril. 2/18/04 no new vesicles. Old vesicles scabbed over.									Y	02/10/2004	02/13/2004	3		PVT	PVT	NONE	NONE . Has eczema	PCN-allergy/ (Egg, milk and peanut allergy)			1						1	Blister; Rash vesicular	DTAP~SMITHKLINE BEECHAM~622B2~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1293AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1061N~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0216851	02/25/2004	GA	50.0	50		M	10/31/2003	Arm with slight pain at inject site. Increased in severity on 5th day to point at which arm from shoulder to elbow throbbing. Treated with heating pad- Has decreased significantly since (arm hurt for 2 weeks following flu vaccine).									U	10/24/2003	10/29/2003	5	NONE	OTH	PVT	NONE	NONE	Allergic to Ibuprofen.	Arm hurts for 2 weeks~Tetanus Toxoid, adsorbed (no brand name)~10~49.00~In Patient		1						1	Injection site pain	FLU3~SANOFI PASTEUR~U1077AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0216852	02/25/2004	IL	40.0			M	02/17/2004	Right arm began to hurt more than from a typical flu shot several days after injection. Increased constant ache in upper arm/neck/shoulder. Activity increased discomfort. Treated with Acetaminophen and 1 dose of Ibuprofen/hot-cold applications. 11/19 arm somewhat better saw doctor who advised to watch it. 11/26/03 continue to ache and in not as strong as he would like-will continue to observe.									U	10/17/2003	10/20/2003	3	NONE	OTH	PVT						1						1	Neck pain; Pain; Shoulder pain	FLU3~EVANS VACCINES~765499~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0214219	02/26/2004					U		Pt was vaccinated on Friday. She immediately felt lightheadedness, hoarse voice.  The next morning she felt a mild difficulty breathing that lasted for 4 days.  One week after vaccination she felt very weak, and had scratchy throat, itching in back, fever, and was diagnosed with bilateral pneumonia.  All 3 other family members (husband and two children) received FluMist on the same day but had no adverse events to report.  She is reportedly healthy, and has no history of allergies or asthma.									U					OTH	OTH	UNK	UNK	UNK			1						2	Asthenia; Dizziness; Dry throat; Dysphonia; Dyspnoea; Pneumonia; Pruritus; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0216895	02/26/2004	DC	49.0	49		M	11/12/2003	Patient received Fluzone 11/10/03. Presented to health unit 11/12/03 with left facial paralyses temperature 98.4 Refresh eye drops for lubrication. THe medical record received on 4/5/04 states headaches, and twitching of left eye.									Y	11/10/2003	11/12/2003	2	Diagnosed by neurologist- Bell's Palsy- Resolved 1/2004. Labs abnormal, positive antibodies for varicella, herpes simplex.	OTH	PUB	Zyrtec	NONE	Seasonal allergies.			1						1	Facial palsy; Headache; Laboratory test abnormal; Muscle twitching; Viral infection	FLU3~SANOFI PASTEUR~U1146CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0216896	02/26/2004	FL	18.0	18		F	02/20/2004	Patient received Fluvirin 0.5 ml in left dorsotransverse /intramuscularly on 1/23/04. On approx. 1/29/04 pt. noticed runny nose, runny eyes, maybe a slight temp but it was not checked also complained of bad headache a day or 2 later. On 2/1/04 pt. stated tongue was numb in AM. By the evening her left side of face was swollen and her speech was slurred. Went to ER that evening, cat scan done and referred to a neurologist. Put on Prednisone and Acyclovir. Still unresolved as of 2/20/04. medical records state facial paralysis. msv				Y					U	01/23/2004	02/01/2004	9	Cat scan-negative. Mom states no lab drawn. Mom states diagnosed with Bell's Palsy.	OTH	PUB	NONE	NONE	Mom stated NONE			1						1	Dysarthria; Face oedema; Facial palsy; Headache; Lacrimation increased; Rhinorrhoea; Tongue paralysis; Dysarthria; Facial palsy; Upper respiratory tract infection	FLU3~EVANS VACCINES~765971~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~EVANS VACCINES~765971~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0216912	02/26/2004	WI	69.0	67		M	02/05/2004	This report describes the occurrence of arthritis in a 69 year old male who was vaccinated with Lyme disease vaccine recombinant OspA (Lymerix) for prophylaxis.  This report was received from the subject and has not been verified by a physician or other healthcare professional.  Reportedly, the subject had no relevant medical history, concurrent conditions, or concurrent medications. Reportedly, the subject experienced no adverse events following previous immunizations.  The subject stated that he received injections of Lymerix in approximately January/February 2000, one month after the first injection, and November/December 2000.  The third injection was administered nine to eleven months after the first injection, rather than the recommended interval of twelve months. At the time of administration of the third Lymerix injection, the subject reportedly received an injection of influenza virus vaccine (manufacturer unknown).  The subject stated that during the course of the year 2001, he developed arthritis in both hands.  He was reportedly referred by his physician to a specialist, who recommended corticosteroid injections into his hands.  The subject reported that the corticosteroid injections were very painful and offered  very little relief from the arthritis symptoms.  As of 04/30/03, the arthritis persisted.				Y					N	11/01/2000			UNK	PVT	PVT	UNK	UNK	UNK		A0406761A	1						1	Arthritis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|LYME~GLAXOSMITHKLINE BIOLOGICALS~~3~~LA~LYME (LYMERIX)~1	USA	Emergency room visit	Influenza
0216981	02/27/2004					M		A report was received from a health care professional on 11/18/03 concerning a vaccinee of unspecified demography who experienced thyroid storm, which was considered medically significant (OMIC) in the same month as receiving influenza vaccine (brand unspecified) in November 2003. The vaccinee has a history of hyperthyroidism. On an unspecified date in November 2003, the vaccinee experienced thyroid storm. The outcome of the event was not reported. There was insufficient information to determine the reporter's causality assessment. Update 1 2/16/04: A follow up report was received from a health care professional indicating that the vaccinee had received a shot of Fluvirin several years previously and subsequently developed thyroid storm (date of onset and vaccination not known). The vaccinee has received several vaccinations since then including Fluvirin in November 2003 without reaction.									U					UNK	UNK			History of hypothyroidism		PJP200301106	1						1	Thyrotoxic crisis; Vaccine positive rechallenge	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0216985	02/27/2004	CA	65.0			F	02/26/2004	Client came to clinic at 11:45 am at 2/25/04 complained of affected arm 2 prime vaccination of flu vaccine in 11/03. Asked client why she waited to Follow up arm pain and loss of range of motion- client had no response. Referred to Private medical doctor to determine cause and treatment.									U				UNK- at PMO	PUB	UNK	UNK	None- prescreened	None stated that was contra indicated for flu.			1						1	Joint range of motion decreased; Pain	FLU3~EVANS VACCINES~765142~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0217005	03/01/2004	OK	37.0	37		M	02/10/2004	Sinus infection on 12/24/04- I subsequently began having back pain with tingling in arms (hands) and feet. The tingling is new in my legs- have had spasm, burning and joint pain throughout my hands/feet/back and other parts of my body- have never had these symptoms till I received flu shot.				Y					N	12/18/2003	12/24/2004	372	Arthritis screen/SED rate	OTH	PVT	NONE	NONE	NONE			1						1	Arthralgia; Back pain; Infection; Muscle spasms; Paraesthesia; Skin burning sensation	FLU3~EVANS VACCINES~765971~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0217006	03/01/2004	MI	64.0	64		F	10/27/2003	Client complained of waking up with a rash on her left hip, thigh and left arm on 10-21-03. Client went in to see her private doctor on 10-23-03. She was instructed to get over the counter Benadryl and return in two weeks if rash didn't resolve. Client continues to have rash. Client plans to follow up.				Y					N	10/20/2003	10/21/2003	1	NONE	PUB	UNK	Daily Vitamins, Zoloft, Viox	NONE	Pseudo Xanthoma Elasticum. Allergies: PCN, dairy, sulfa, myocin's, steroid, and all dyes.		MI2004006	1						1	Rash	FLU3~EVANS VACCINES~765852~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0217007	03/01/2004	MI	73.0	73		M	10/28/2003	Client states after getting the influenza vaccine he drove to the pet supplies store to pick up some pet food. Client states he started getting migrane headaches and then he blacked out and when he awakened he was on the floor. Two individuals helped him up on his feet but his right arm and left hand war hurting. Public health nurse advised client to go to the nearest ER or follow-up with his physician. Follow-up call was made. Client has an appointment with his physician on 10/30/03. 11/18/03 spoke with Mrs. states her husband did follow-up with his physician. From the physicians evaluation, Mrs. said the doctor states Mr. is a diabetic and did not eat for 8 hours that day. In result of him fainting he has a broken hand. Mrs. also states he has a history of having migranes.				Y					U	10/23/2003	10/23/2003	0		PUB	PUB	Refuse to give the names of the medications.	NONE			MI2004007	1						1	Loss of consciousness; Migraine; Pain	FLU3~EVANS VACCINES~765852~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0217008	03/01/2004	CA	53.0	55		F	11/07/2003	Suspect arthus reaction, seems to be at site of Pneumovax. Had intense local soft tissue induration as well as profound malaise, fatigue, constitutional symptoms.				Y					Y	11/06/2003	11/06/2003	0	CBC 11/7	PVT	PVT	UNK					1						1	Fatigue; Injection site induration; Malaise; Type III immune complex mediated reaction	FLU3~EVANS VACCINES~165670~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~W0906~1~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|PPV~MERCK & CO. INC.~1196M~1~SC~RA~PNEUMO (PNEUMOVAX)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0217009	03/01/2004	MA	92.0	92		F	01/22/2004	Glt flu vac 24 hrs later temp 103 pt have of 100 due thrombocytopenia (bone marrow pl). As I said in my email my mom had fever off and on for over one year. She is 92 and has a very high platelet count. We were told that the fever was most likely due to her underlying bone marrow condition. When she had her flu shot (only the 3rd in her life). She became very ill, higher fever than ever (shot Thursday pm-sick the night to Sunday night). Couldn't ear or drink on her own. On Monday morning she not only was better but was better than she had been in many months the fever never came back until 2 mo later just for 2 days. But this time related to Tylenol toxicity. She is fine now.									Y	11/06/2003	11/08/2003	2		OTH	UNK		Thrombocytopenia				1						1	Movement disorder; Pyrexia	FLU3~SANOFI PASTEUR~U1145AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0217010	03/01/2004	NY	46.0	46		F	02/20/2004	Pt with pain at injection site since injection, never resolved, has exacerbations of pain last approx. one week at a time. Hurts with some movement and lay on it. 2/20/04 first visit-given course Cerebrex 200mg x 14 days denied redness at site, swelling, fever. Denies numbness, weakness, electric like sensations.				Y					N	12/12/2003	12/12/2003	0		OTH	OTH	Calcium		NONE			1						1	Hypokinesia; Injection site pain; Pain	FLU3~SANOFI PASTEUR~U1081AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0217011	03/01/2004	AZ	0.8	0	.9	M	02/23/2004	Two day post Pediarix lot #21918D2 in the LVL with intense 9cm diameter redness, warmth and swelling. Also received Hib #2, PCV 7 and flu.				Y					Y	01/21/2004	01/23/2004	2		PUB	OTH	NONE	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site warmth	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~21918D2~2~~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~V1091AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~PFIZER\WYETH~495758~2~~RL~HIB (HIBTITER)~1|PNC~PFIZER\WYETH~494305~1~~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0217076	03/02/2004	MN	49.0	49		F	02/24/2004	Monday evening 11/10/03. Influenza and Pneumo 23 was given around 1700 shots were given. 1730 noted dizziness at home. 2000 went to bed-both arms sore, left worse than right. Absolute fatigue, headache, sinus feeling pressure. Took Tylenol/ Ibuprofen, tried another medication for relief. Had a rough nite, up six times to get relief of pain, aches in knees in the nite. Tuesday 11/12/03. Kind of lifted. Left arm still sore, shoulder joint to knuckles stiff couldn't use it, muscles felt sore and site hot. Right arm minimal soreness. Felt miserable, no appetite. Sinus headache went to a migraine in the afternoon. 6pm went to be shivering under 3 quilts, vomited, diarrhea started. Taking a lot of Ibuprofen. Wednesday 11/13/03. Headache gone. Couldn't bend elbow today. Slept in the afternoon and went to work, was a little better that she could go to work. Got real hot couldn't drive. Felt like I had run a marathon. Went to the doctor for another reason, doctor noted fast heart rate. Thursday 11/14/03. Morning arm now bends. Stomach upset, not wanting to eat. Sinus headache, more diarrhea and noted stools dark. Nosebleed and dizziness at intervals. pt called our agency at this time. Pt was encouraged to seek medical evaluation and report the above. She refused. Friday 11/15/03. No breakfast, no appetite, nervous stomach, denies headache and migraine, can move fingers, knee aches and elbow aches gone. 11/20/03 shoulder to elbow stiff. 11/30/03 stiff and aches.									Y	11/10/2003	11/10/2003	0		PUB	UNK		NONE	Sensitivity to yeast.			1						1	Anorexia; Arthralgia; Chills; Diarrhoea; Dizziness; Epistaxis; Fatigue; Headache; Heart rate increased; Joint stiffness; Migraine; Pain; Sensation of pressure; Sinus headache; Sleep disorder; Vomiting; Abdominal discomfort; Anorexia; Arthralgia; Chills; Diarrhoea; Dizziness; Epistaxis; Faeces discoloured; Fatigue; Feeling hot; Heart rate increased; Hypokinesia; Influenza like illness; Injection site warmth; Joint stiffness; Migraine; Myalgia; Pain; Sinus headache; Vomiting	FLU3~SANOFI PASTEUR~U1094AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0029N~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U1094AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0029N~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0217077	03/02/2004	WA	56.0	55		F	02/26/2004	Pain upon administration, arm muscle sore and rigid. Pain continued and moved across top of left shoulder and left back. Client interviewed on 2/24/04 and states cannot move left arm about shoulder without terrible shooting pain and chronic pain.									U	11/12/2003	11/12/2003	0	2/24/04 referred by physician for x-ray, possible MRI	PUB	PVT	NONE	NONE	Fibromyalgia; No known allergies.			1						1	Muscle rigidity; Myalgia; Pain	FLU3~SANOFI PASTEUR~U1122AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0217126	03/02/2004	TX	40.0	40		M	03/02/2004	Couldn't stand,walk feel feet.Headache, fever. became paralized from head to toes.Had a trach,on resporator for 33days,couldn't walk,stand for months.Treated in hospital on machines and then home with pain meds. and had to be rehabilatated for months.			Y	Y	Y	34		Y	N	10/12/1976	04/13/1977	183		UNK	UNK	NONE	NONE	NONE			1						1	Difficulty in walking; Headache; Neuropathy; Paralysis; Pyrexia; Fall; Guillain-Barre syndrome; Headache; Paralysis; Pyrexia; Fall; Guillain-Barre syndrome; Headache; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~2~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~2~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLUX~UNKNOWN MANUFACTURER~~2~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0217126	03/02/2004	TX	19.0			M	03/02/2004	couldn't feel legs.fever, headache,falling.Was hopitalized became paralized from head down.Had a trac.and put on resporator for 33days in ICU then moved to room 4wks. on pain meds,cortosone,antibiotics and rehab.Diag. with Guillain-Barre Syndrome			Y	Y	Y	120		Y	N	04/14/1977	04/18/1977	4		PVT	PVT		none	none			1						2	Difficulty in walking; Headache; Neuropathy; Paralysis; Pyrexia; Fall; Guillain-Barre syndrome; Headache; Paralysis; Pyrexia; Fall; Guillain-Barre syndrome; Headache; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~2~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~2~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLUX~UNKNOWN MANUFACTURER~~2~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0217126	03/02/2004	TX	19.0			M	03/02/2004	couldn't feel legs,falling.fever,headache.In hospital on respirator 33days with trach., in ICU then in room 1month with rehab. stong pain meds,antobotics cortosone and other meds which I can't remember.Diagnosis-Gillian-Bare Syndrome			Y	Y	Y			Y	N	04/12/1977	04/18/1977	6	scans,lab.daily,xrays and many more	PVT	PVT		no	none			1						3	Difficulty in walking; Headache; Neuropathy; Paralysis; Pyrexia; Fall; Guillain-Barre syndrome; Headache; Paralysis; Pyrexia; Fall; Guillain-Barre syndrome; Headache; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~2~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~2~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLUX~UNKNOWN MANUFACTURER~~2~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0217132	03/03/2004	FL	79.0	78		F		This subject is a 79 year old female who died while enrolled in a Comparative Randomized Study of Safety and Immunogenicity Of A Non-Adjuvanted RSV Vaccine VS. An RSV Vaccine Adjuvanted With Aluminum Phosphate When Administered Concomitantly With A Licensed Influenza Vaccine in High-Risk Adults > or = 65 Years Of Age. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/21/03. The subject died on 1/13/04, 84 days post immunization. The investigator has not reported the causality. Additional info to follow when available. Additional information received 27Feb2004. The death was reported by the Investigator as not related to the study vaccine. Additional information received 10March2004. Copy of Death certificate received. Cause of death is not legible, no autopsy was performed. Additional information received by phone on 12Mar04. Verbal report from study coordinator that the cause of death was non-small cell lung cancer. Written following report requested. Additional information received 12Mar04. Written report: Diagnosis: Subject died on January 13, 2004. Manner of death-natural-Immediate cause-non-small cell lung Carcinoma.	Y	01/13/2004							N	10/21/2003	01/13/2004	84		UNK	UNK	RSV/ Placebo		COPD, hematemesis, blood in stool, abdominal pain, thrombocytopathy, breast CA		2004006821	1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U1137HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|UNK~UNKNOWN MANUFACTURER~~UNK~~~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA	Results in Death	Influenza
0217139	03/03/2004		27.0	27		M	11/20/2003	R arm developed a large area of non-tender blotchy erythema > 16cm across that resolved slowly over approximately 3 weeks.				Y					Y	10/19/2003	10/20/2003	1	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Erythema; Rash macular	FLU3~EVANS VACCINES~765710~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0217147	03/03/2004	IA	1.83	1	.8	F	02/25/2004	Seizures as reported by mom (21 seizures observed).  Nurse follow up on 05/18/04 states: tonic-clonic, lethargy, irritable.				Y					U	12/17/2003	12/18/2003	1	UNK. Currently at hospital. Nurse follow up on 05/18/04: EEG abnormal.	PUB	PUB	UNK	Down's Syndrome	Down's Syndrome- Partial AV Canal		IA04001	1						1	Agitation; Convulsion; Electroencephalogram abnormal; Hypertonia; Somnolence	FLU3~SANOFI PASTEUR~U1254AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0217238	03/03/2004	OH	60.0	60		F	10/16/2003	Patient received flu vaccine on 10/14/03. She developed soreness at injection site on left arm. The next day she reports soreness and swelling of an area 2x2 around the injection site. There was still reddness at needle site. Patient allergic to Penicillin and Sulfa. 10/16/03 patient reports reduction in swelling.									Y	10/14/2003	10/15/2003	1	None	PVT	PVT	Norvac, Lipitor	None	HTN, PVD  Allergies to Penicillin and Sulfa			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~EVANS VACCINES~765196~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0217240	03/03/2004	OH	5.0	5		F	01/12/2004	Complained of stomach, became light headed, pale and diaphoretic,and weak.  Squad responded, child may or may not have passed out. Right arm site - no reddness or irritation.  Recovered without any intervention by squad. Advised to see pediatrician/appointment made for 3:15pm.				Y					Y	01/09/2004	01/09/2004	0	None	PUB	PUB	None	None	None	Intusseption~Rotavirus (RotaShield)~~0.20~In Patient		1						1	Abdominal pain upper; Asthenia; Dizziness; Hyperhidrosis; Pallor	FLU3~EVANS VACCINES~U1270AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0217242	03/03/2004	OH	35.0	35		F	02/06/2004	1/12/04, client called stating that since flu shot (12/3/03) and approximately 2 months before shot, she was experiening numbness of face and chemical taste in mouth that had gotten worse since flu shot. Client stated that she is allergic to formaldihyde - she did not tell nurse she was allergic to formaldihyde. Still having problems				Y					U	12/03/2003			None	PUB	PUB	Off meds	None	Allergies to cats, dogs, dust, mold, glycerin, spandex, and formaldehyde			1						1	Dysgeusia; Hypoaesthesia	FLU3~SANOFI PASTEUR~U1270AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0217249	03/03/2004	ID	32.0	32		M	03/03/2004	diagnosed with guillian-barre syndrome in January of 2002 after 6 months after completing the anthrax vaccination. Also received a flu shot 1 month prior to being diagnosed with guillian-barre. was on life support for 9 and a half weeks. completely paralyzed for 4 months. received extensive physical tharapy for 11 months. had 2 plasma transfusions, 2 bottles of IV-IG. Follow up information received 06/02/2004:Fingers still tingle. Have muscle fatigue and joint pain.			Y	Y	Y	330		Y	N	12/15/2001	01/26/2002	42		UNK	UNK			none			1						1	Arthralgia; Guillain-Barre syndrome; Muscular weakness; Paraesthesia; Paralysis	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0217258	03/03/2004	UT	81.0	81		F	03/03/2004	Client received a flu shot on 10-08-03 at a Clinic held at a local grocery store.  No previous health complants before shot.  Approx. 2 days after shot complaint of Left side, posterior neck pain, along with muscle soreness to both arms, deltoid area. Complained of pain in both knee joints also. No fever noted, No swelling or reddness noted. Descrbes pain as someone sticking a knife into arms, Pain is intense.  Rates pain as 10 on a 1-10 scale. On 10-23-03 blood tests were done to see if meds client was taking was causing pts problems.  On 10-28-03 visited doctor.  Reports blood tests were normal. Started pt on Vioxx,and other pain med Lortab?  Vioxx did not help so revisited doctor on 11-25-03, started on Prednisone 20 mg.  Med helped.  Referred pt to Rheumatoidologist on 12-08-03.  Prednisone was reduced, to 2.5 mg. with terrible pain returning.  Visited doctor again,2-12-04 increased Prednisome to 5mg and added Methatrextate.  Rates pain as 8 on 1-10 scale today 3-03-04. Scheduled for additional follow up appointments in March 04.				Y					N	10/08/2003	10/10/2003	2		UNK	PVT	Zocor  Lotensen, HcTZ, Calcium,	Healthy				1						1	Arthralgia; Myalgia; Neck pain	FLU3~EVANS VACCINES~765704~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0217259	03/03/2004	WI	43.0	43		F	03/03/2004	Persistent pain at injection site in right deltoid, began several hours after injection received and has been present since. Has lessened significantly but still present. Treatments include Tylenol (first few days only), warm moist heat to site, rest.									N	12/04/2003	12/04/2003	0	None	PVT	PVT	Synthroid, Sarafem	none	Allergies to Sulfa, Motrin, Dolobid, Trazadone Hypothyroid, GERD			1						1	Injection site pain	FLU3~SANOFI PASTEUR~766055~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0217181	03/04/2004	NY	61.0	61		M	02/27/2004	Patient received flu vaccine on 10/20/03. On 11/11/04 symptoms of head tingling, numbness in extremities. Diagnosed with GBS on 11/14/03 at hospital. Currently is wheelchair bound and receiving water therapy. The discharge summary received on 3/23/04 states spinal tap headache and hypertension. The medical record received on 3/23/04 states gait unsteady and weakness.					Y				U	10/20/2003	11/11/2003	22	IVIG administered. CSF abnormal.	PUB	PUB	NONE	NONE	Interstitial lung dis, pulmonary fibrosis, COPD, cardiomegaly, allergy/ aspirin. Medical History states head cold, flu-like symptoms.			1						1	Asthenia; CSF test abnormal; Gait disturbance; Guillain-Barre syndrome; Headache; Hypertension; Hypoaesthesia; Paraesthesia; Guillain-Barre syndrome	FLU3~SANOFI PASTEUR~U1138AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~U1138AA/U1141AA~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0217184	03/04/2004	AK	50.0	50		F	01/13/2004	Vaccine administer IM to pt. per pt's requests. No problems with previous dose or allergy to egg products. Within 20-30 minutes pt experienced swelling of throat no difficulty breathing pt's signs and symptoms resolved within the hour. Administering nurse not informed of reaction until over and hour later. No treatment given.									Y	11/14/2003	11/14/2004	366	UNK	OTH	OTH	UNK	NONE	Allergy to codeine and Emycin		AK200422	1						1	Pharyngeal oedema	FLU3~SANOFI PASTEUR~U1141AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0217230	03/04/2004	WA	2.0	2	.0	M		Overnight after immunizations developed fever, generalized papular rash over body, pain at right upper leg injection site with redness and swelling.  Hep A was given at that site.									Y	10/14/2003			Rapid strep test: negative; father refused lab work	PUB	PUB	PPD	NONE	35 week premature; chicken pox at 10 months; viral exanthum;			1						1	Injection site erythema; Injection site oedema; Injection site pain; Pyrexia; Rash papular	FLU3~SANOFI PASTEUR~U1091AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~759A2~1~IM~RL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~493482~4~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0217260	03/04/2004	MN	7.0	7		M	03/03/2004	Nose									U	02/25/2004			Pt fine	PVT	PVT	NONE	NONE	NONE			1						1	Unevaluable event	FLUN3~MEDIMMUNE VACCINES, INC.~500003P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0217261	03/04/2004	MN	7.0	7		M	03/03/2004	None									U	02/25/2004			Pt fine	PVT	PVT	NONE	NONE	NONE			1						1	Unevaluable event	FLUN3~MEDIMMUNE VACCINES, INC.~500003P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0217272	03/05/2004	NC	28.0	28		M	10/27/2003	At 11 days after immunization, pt seen in ER for cellulitus L arm from axilla to mid-upper arm. Received antibiotics x 48 hrs. Since receiving smallpox immunization on the arm, noticed local redness, bump, blister, pus-filled blister, sore under arm (redness from site down arm then under armpit), muscle aches-under arm, restricted activity, took medication (antibiotics), visited clinic, hospitalized (2 days) and pain at site at day 9. Pt reported redness and swelling in day 11 of vaccination. Reported to ED and hospitalized for IV ABX. Erythema to axillary surrounding site and along tricep muscle. Erythema resolved post 48 hrs ABX and d/c home. F/U 2 days post discharge.					Y	2			Y	10/14/2003	10/23/2004	375		MIL	MIL	Allegra QD (am) for hay fever	NONE	Allergy to shellfish, iodine, Motrin (animal dander seasonal), hay fever.			1						1	Blister; Cellulitis; Hypokinesia; Injection site erythema; Injection site pain; Myalgia; Oedema; Rash	ANTH~EMERGENT BIOSOLUTIONS~~7+~SC~RA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1	USA	Hospitalisation	Influenza
0217278	03/05/2004	CA	10.0	10		F	02/03/2004	On Jan 26 04 at 0920 pt was given influenza vaccine 0.5CC ID in L. arm at approx. 0925 pt fainted and hit her head on the exam table. At 0929 pt was give O2 via mask at 10L/min and EPI-PCN JP 0.15mg.0/3Ml, right thigh. Pt complained of lump in throat.									Y	01/26/2004	01/26/2004	0		MIL	MIL	EPI-PCN JR 0.15 MG/ 0.3ML IM, right	NONE noted.	Pt had an egg allergy at 18 months of age.			1						1	Injury; Syncope	FLU3~EVANS VACCINES~765416~1~ID~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0217379	03/05/2004	OK	24.0	24		F	03/05/2004	26-year-old female who received her influenza vaccine in Oct 2002 and the following day felt fatigued and developed a rash on her knees. Stated she never had anything like this before and within one week the rash started to spread up to her abdomen, chest and down to feet. Stated the rash was not hives and described as small red bumps with white tops. Stated the itching was severe and was a deep itch. She denied any respiratory problems, problems swallowing or speaking, nausea, vomiting, diarrhea, or eye swelling.   She went to the medical clinic and received topical ointments, unknown name or type, with no relief. She returned to the clinic several days later and was then given a steroid dose pack. Within one week of taking the steroid dose pack her rash cleared.  Patient (pt) reports a history of eczema during her childhood. Did have a dermatology evaluation and was given steroid creams, which helped. Pt denied any aggravation of eczema by foods. States her eczema was primarily on her face. Reports that her eczema has not bothered her. She reports occasional breakouts on her hands, especially the area around her rings. Breakouts described as small red hard bumps and notices it more if she does not dry her hands well, or if she is in contact with harsh chemicals. Has a rare outbreak on her face. States her face will feel dry around her mouth. Currently she applies a natural progesterone cream to the outbreak areas with relief.   When comparing the rash following her immunization with that of her eczema she replied that it was similar but different. Her eczema does not have white tops, only involves face and hands and not as itchy. The rash following her immunization had white tops, involved a greater portion of her body, spread quickly and was itchy.  She denies any new foods, soaps, detergents, or creams. Reports no problems when she eats eggs or gelatin based products.				Y					Y	10/24/2002	10/25/2002	1		MIL	MIL		denies	eczema			1						1	Condition aggravated; Fatigue; Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~UO880AA~5~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0217380	03/05/2004	OH	0.4	5		F	03/05/2004	MOM STATES CHILD BEGAN WITH RASH RIGHT CHEEK & BOTH CHEEKS SWOLLEN APPROXIMATELY 1/2 HOUR AFTER IMMUNIZATIONS GIVEN. THE NEXT MORNING (3/4)CHILD WOKE WITH RASH BOTH CHEEKS AND FACE STILL SLIGHTLY SWOLLEN ALL OVER.  CHILD HAD APPOINTMENT WITH ENT FOR PREVIOUS SINUS PROBLEMS THAT AM.  DR. STATED HER THROAT WAS ALSO SLIGHTLY SWOLLEN.  AFTER DR. APPOINTMENT CHILD SPIKED A FEVER OF 101.8.  CHILD TAKEN TO ER AND WAS GIVEN BENADRYL AND MEDICATION FOR FEVER AND SENT HOME.  FRIDAY MORNING (3/5) CHILD WOKE WITH COUGH AND C/O TROUBLE BREATHING.  MOM CALLED 911 AND WAS GIVEN BREATHING TREATMENT AS PULSE OX WAS ONLY 86 AND TRANSPORTED TO HOSPITAL. PHYSICIAN STATED CONDITION RELATED TO ANTIBIOTIC CHILD HAD BEEN ON (SULFAMETHOXAZOLE).  MOM SPOKE WITH FAMILY PHYSICIAN WHO PUT CHILD ON PEDIAPRED FOR 3 DAYS AND INCREASED HER ZYRTEC (WHICH SHE HAS BEEN ON FOR QUITE A WHILE).				Y					Y	03/03/2004	03/03/2004	0	NONE.	PUB	PUB	ZYRTEC NASINEX NASAL SPRAY SULFAMETHOXOLE	NONE.	SEEING PHYSICIAN FOR SINUS PROBLEMS. DIAGNOSED ALLERGY TO CATS.			1						1	Cough; Dyspnoea; Pyrexia; Rash; Swelling	DTAP~SANOFI PASTEUR~U0996CA~5~IM~RA~DTAP (TRIPEDIA)~1|FLU3~EVANS VACCINES~766321~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~X0146~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0272N~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0217181	03/06/2004	NY	61.0			U	03/06/2004	Approx 3 weeks the flu shots, the patient was diagnosed with Guillain Barre Syndrome.  Is still recovering.			Y	Y	Y	4			U	10/20/2003	11/11/2003	22	Spinal Tap done	UNK	UNK	None.  The vendor is not sure of the correct Lot #.	None	None			1						2	Asthenia; CSF test abnormal; Gait disturbance; Guillain-Barre syndrome; Headache; Hypertension; Hypoaesthesia; Paraesthesia; Guillain-Barre syndrome	FLU3~SANOFI PASTEUR~U1138AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~U1138AA/U1141AA~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation	Influenza
0217382	03/06/2004	DE	30.0	36		M	03/06/2004	Lg bruised, red area, 4 inches in diameter. Hot to the touch. Hard & painful for 4 days.									U	10/05/2003	10/05/2003	0		MIL	MIL	None	None	None			1						1	Contusion; Erythema; Injection site induration; Injection site pain; Injection site warmth	ANTH~EMERGENT BIOSOLUTIONS~FAV071~UNK~SC~~ANTHRAX (BIOTHRAX)~1|FLU3~EVANS VACCINES~765412~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0217388	03/07/2004	OH	1.0	1	.0	F	03/07/2004	Red spots on torso, neck, face and back.  Fever of 103.7 F.  Given tylenol and oatmeal bath									Y	02/24/2004	03/05/2004	10		MIL	MIL						1						1	Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~U1172AA~2~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~0679N~1~IM~LL~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~0898N~1~IM~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0215835	03/08/2004	GA	1.3	1	.3	M	02/02/2004	Seizure times 2; less than 5 minutes each on the night after vaccine administration. Was also irritable in clinic the following day.					Y	1			Y	01/29/2004	01/29/2004	0	NONE	PVT	PUB	NONE	NONE	Cocaine exposure in utero.			1						2	Anorexia; Convulsion; Electroencephalogram abnormal; Irritability; Pyrexia; Convulsion; Irritability	DTAPH~UNKNOWN MANUFACTURER~~UNK~~~DTAP + HIB (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PNC~PFIZER\WYETH~~UNK~~~PNEUMO (PREVNAR)~1|DTAP~SANOFI PASTEUR~U1007BA~4~IM~LL~DTAP (TRIPEDIA)~2|FLU3~SANOFI PASTEUR~U1232BA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~MERCK & CO. INC.~0589N~4~IM~LL~HIB (PEDVAXHIB)~2|PNC~PFIZER\WYETH~494304~4~IM~RL~PNEUMO (PREVNAR)~2	USA	Hospitalisation	Influenza
0217333	03/08/2004	RI	73.0	73		M	03/02/2004	12/10/93 pt reported to Er-2 wk hx of mental status change. Pt received flu vaccine in Nov of 2003. Neuro exam-grossly nonfocal, profound confusion and memory loss. Other etiologies ruled out. pt independent to ADL's prior to this time. No aditional info available. Pt came into ER with reaction.					Y	16	Y		U	11/01/2003	12/01/2003	30	All negative: Lyme, HIV, Spinal Fluid, IgG, Viral and bacterial cultures negative; West Nile negative; HSV negative	OTH	OTH	Lipitor; Aspirin; Ativan	NONE	NONE			1						1	Amnesia; Confusional state; Mental impairment	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0217334	03/08/2004	OK		61		F	12/11/2003	Flu shot given 12-9-03 to pt without difficulty- patient returned 12-11-03 with approx 2 in bruise by 1 in at right arm- small amount of swelling- warm to touch - referred patient to private medical doctor for evaluation. Tc to patient 12/12/03- pt states slightly approved- still plans to see doctor.									U	12/09/2003	12/10/2003	1		PUB	UNK		NONE	NONE		AR0423	1						1	Contusion; Feeling hot; Swelling	FLU3~SANOFI PASTEUR~U1095AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0217335	03/08/2004	AR	36.0	36		F	11/06/2003	11:40 complained of severe itching all over. She was immediately taken to MD. She was given Solumedrol 12 mg IM, Benadryl 50 mg IM, Epinephrine 0.33 cc SC etat. Given Rx of Benadryl orally and Epi pin and Prednisone to take home. Slept well during the night and plans to return to work 11-7-03. 11-6-03 follow-up unable to work today due to sleepiness. Plans to work. 11-7-03 Doing well.				Y					Y	11/05/2003	11/05/2003	0	UNK	PUB	PUB		NONE known.	NONE known.		AR0419	1						1	Pruritus; Somnolence	FLU3~SANOFI PASTEUR~U1144AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0217337	03/08/2004	VA	1.25	1	.2	F	03/05/2004	Fever 102 degrees F noted 2 weeks after vaccine for a week to present. Pink papules noted 3/3/04 and 3/4/04 (face and trunk). Diagnosis made 3/4/04.									U	02/16/2004	03/03/2004	16	rule out UTI u/a neg. Awaiting urine culture results from lab.	PVT	UNK		NONE				1						1	Pyrexia; Rash papular	FLU3~SANOFI PASTEUR~U1170AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE096AA~4~IM~LA~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0819N~1~SC~RA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA		Influenza
0217338	03/08/2004	NC	31.0	30		M	03/05/2004	Redness. Edema and pain centered on elbow and upper arm near inject site. Warm to touch. Assessment: Cellulitis secondary to anthrax vac.									Y	03/03/2004	03/03/2004	0	NONE	MIL	MIL	PPD Shot	NONE				1						1	Cellulitis; Erythema; Feeling hot; Injection site oedema; Injection site pain	ANTH~EMERGENT BIOSOLUTIONS~FAV096~6~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1293AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0217356	03/08/2004	WV	36.0	36		M	02/20/2004	10/25/03 got stomach pains and eating problems, went to ER on 10/26/03. Admitted for couple days, d/c went back to work; 1-2 nights later was out getting food and got confused and almost unable to get home, called dad, dad arrived at pt home next day. Contact Dr, MRI done a couple weeks later; unable to work or be alone. Disabled diagnosed with ADEM-Acute disseminated encephomyopathy by Dr who said may recover in 6-9 months. Dr referred pt to neurologist, neurologist referred also to another doctor and an endocronologist. Also seeing a psychiatrist. Dr referred pt to a gastroenterologist. Dad said he is preparing to move soon with him. I saw pt-he sat in passenger's side of vehicle. I told pt sign here and pointed to signature area and pt said who me-he did this same thing two times-while signing and releases. Meds now are Prozac for depression, clonopine for depression, Protonex for stomach/ gas. In the past was on Rimeron and Zoloft-was on for 1 year and stopped about 6 mo before 10/9/03.This is a 36 year old male who presents to the ER saying that he has had nausea and vomiting 5-8 days with a stomach ache in mid abdomen. He reports that he hasn't eaten in the last two days any food. Pt tells the ER physician that he duobled on his Cortef the last two days but did not take that morning upon arrival to the ER. Pt reports this is similar to when he has had asthma crisis but it is also similar to when he has been really depressed. Noted in the ER record, pt says he has a new job at work. He saying that his nausea and vomiting always gets better when he has Valium because that puts him to sleep and multiple bizarre comments as noted in the ER record. Pt actually was seen in my office for the first time on Monday, October 20, at which time he was seen because he called the office he couldn't hold together anymore is what he told the office. He didn't have a pt appointment until the middle of November but per request of my staff, I saw him earlier to make sure he wasn't suicidal. At that time, I re-started his Prozac which he had ran out of. Pt was requesting Valium at that time in leu of his Klonopin which I explained I would not do until I got medical records and further assessed him .pt then called my office back on Friday requesting Valium because he needed ti to get him through this spell. He said the Prozac wasn't working. At that time, he did not tell anybody in the office that he had some nausea or vomiting. He actually was at work when he called. He spoke to two of my nurses who assessed that he did not report any illness what so ever. Information from Annual Follow-up report states last I heard, pt died - due to Addison complications and not a Rx to flu vaccine.					Y				N	10/09/2003	10/25/2003	16	MRI-ADEM	OTH	PVT	Cortef	NONE	Addison's; phenergan jitters; obsessive compulsive disorder; mood disorder, not otherwise specified; allergies phenergan and adhesive tape.			1						1	Abdominal pain upper; Anorexia; Confusional state; Depression; Encephalopathy; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U01076AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0217408	03/09/2004	MI	9.0	9		F	02/04/2004	Received telephone call from pt's mom 11:20am on 01/28/04.  She states her son has puffy eyes and redness under both and around his cheeks.  No fever.  Complained of stomach ache.  Was informed by MD that this was a reaction from the flu vaccine.				Y					Y	01/27/2004	01/28/2004	1	NONE	PUB	PVT	NONE	NONE	NONE		MI2004010	1						1	Abdominal pain upper; Erythema; Eyelid oedema	FLU3~SANOFI PASTEUR~U1098AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0217409	03/09/2004	MI	41.0	41		F	01/08/2004	Client states within 2 hours after receiving her flu shot, she had pain halfway up her upper left arm and was unable to move her arm.  Client went to physician on 12/30/03 and was examined.  The physician gave the client a cortisol injection.  Client states she is now able to lift her arm but is still unable to move it from side to side.				Y					N	12/02/2003	12/02/2003	0	NONE	PUB	PUB	Allegra;	NONE	Dust, grass, rash following ASA as a child;		MI2004008	1						1	Hypokinesia; Injection site pain	FLU3~SANOFI PASTEUR~U1264AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0217620	03/09/2004	OH	42.0	41		F	03/09/2004	Tingling in hands and feet, ascended to elbow and waist.  Weakness in arms, legs.  Hospitalized x 1 day.  Still have residual tingling in hands and feel.  Diagnosed with Guillian Barre Syndrome.  Still with continual tingling hands and feet. The medical records received on 4/5/04 states headache, blurred vision, palpitation, and sweaty palms. discharge summary states viral infection. msv					Y	1			N	12/05/2003	01/08/2004	34	Spinal tap, MRI, Blood work, EMG. Cholesterol elevation.	UNK	UNK	Toprol XL	Viral illness, sinus congestion	Mitral Valve Prolapse, migraine, supra ventricular tache			1						1	Amblyopia; Asthenia; Blood cholesterol increased; Guillain-Barre syndrome; Headache; Hyperhidrosis; Palpitations; Paraesthesia; Viral infection	FLU3~EVANS VACCINES~U1269AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0217623	03/09/2004	TX	36.0	36		F	03/09/2004	2-3 days after immunizations went to sick-call with a migraine, was started on pain reliever. Area of AVA injection swelled and was very itchy for several days, no redness noted, firm tender nodule approx 1/4 in diam developed. Per annual follow up report, Continued with increased migraine headaches, chronic fatigue 03/23/2005.								Y	N	01/07/2003	01/09/2003	2	12/20/03 MRI of brain with contrast - normal 12/09/2003 EKG - normal no tests done at time of original report to sick call	MIL	MIL	none	NONE	Occasional Migraine headaches, not more than 1 per month			1						1	Condition aggravated; Fatigue; Injection site mass; Injection site pain; Injection site swelling; Migraine; Pruritus; Condition aggravated; Migraine	ANTH~EMERGENT BIOSOLUTIONS~FAV063~1~SC~UN~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~40200040~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0717M~1~IM~UN~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~U1428~1~SC~UN~POLIO VIRUS, INACT. (POLIOVAX)~1|MEN~SANOFI PASTEUR~UB080AA~1~SC~UN~MENINGOCOCCAL (MENOMUNE)~1|MMR~MERCK & CO. INC.~0969M~3~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|TTOX~SANOFI PASTEUR~U0818AA~4~IM~UN~TETANUS TOXOID (NO BRAND NAME)~1|TYP~SANOFI PASTEUR~U1073~1~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|YF~SANOFI PASTEUR~UB320AA~1~SC~UN~YELLOW FEVER (YF-VAX)~1|ANTH~EMERGENT BIOSOLUTIONS~FAV063~1~SC~~ANTHRAX (BIOTHRAX)~2|FLU3~SANOFI PASTEUR~40200040~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~MERCK & CO. INC.~0717m~1~IM~~HEP A (VAQTA)~2|IPV~SANOFI PASTEUR~U1428~1~SC~~POLIO VIRUS, INACT. (IPOL)~2|MEN~SANOFI PASTEUR~UB080AA~1~SC~~MENINGOCOCCAL (MENOMUNE)~2|MMR~MERCK & CO. INC.~0969M~3~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~2|YF~SANOFI PASTEUR~UB320AA~1~IM~~YELLOW FEVER (YF-VAX)~2	USA	Disabling	Influenza
0217552	03/10/2004	NY	76.0	76		F		This subject is a 76 year old female who was admitted to the hospital with respiratory failure and COPD exacerbation while enrolled in a comparative randomized study of safety and immunogenocity of a non-adjuvanted respiratory syncytial virus vaccine versus an RSV vaccine adjuvanted with aluminum phosphate when administered concomitantly with a licensed influenza vaccine in high-risk adults > or = 65 years of age. The subject received 2 doses of RSV vaccine or Placebo and Influenza vaccine. The last dose prior to the event was 10/29/03. The first dose was 10/17/02. Subject developed increasing shortness of breath over the last month and purulent sputum, fever, chills and cough over the last 2 weeks. Subject was taken to emergency by ambulance 93 days post immunization on 1/30/04 and admitted the same day with respiratory failure. Subject was placed on BiPAP, and treated with nebulizer treatments, Rocephin 1gm, Zithromax 500mg, Decadron 6mg IV, Prednisone 40mg BID, Vantin 200mg BID. A chest x-ray on 1/30/04 showed COPD and no pneumonia. EKG is normal. There is no history of chest pain. Subject had mild improvement, however her disease is severe with an FVC of approximately 0.5 liter. Seen in consultation with pulmonary and agreed that she is in end stage. Subject declined any further BiPAP and was discharge from the hospital to hospice 4 days later, 3 February 2004. Subject discontinued the study on 2/3/04. The respiratory failure and COPD exacerbation was reported by the investigator as not related to the study vaccine. Additional information received on 3/5/04: Subject was discharged from the hospital on 2/3/4 to hospice. Subject died in hospice on 2/17/04, 111 days post immunization. The death due to respiratory failure and COPD exacerbation was reported by the investigator as unrelated to the study vaccine. Follow up on 03/24/04: Additional information received 03/18/04. Copy of death certificate: Cause of death: Advanced Chronic Obstructive Lung Disease. No autopsy performed.	Y	02/17/2004	Y		Y	4			N	10/29/2003	01/30/2004	93	Negative urinalysis with a white blood cell count of 15.1 with normal hematocrit and platelet count. A troponin is negative on admission. Coags are within normal limits. The SMA-7 is normal except for a bicarb of 34. The initial gas was 7.22/83/132 and the latest gas on BiPAP is 7.34/58/57. Electrocardiogram shows no ischemic changes with sinus tachycardia at a rate of about 105. There is a normal axis. Chest x-ray shows chronic obstructive pulmonary disease, no evidence of pneumonia. FVC of approximately 0.5 liter.	UNK	UNK	Verapamil; Tamoxifen; Albuterol; Atrovent; Pulmicort; Advair; Foradil; Bactroban; Xanax; Verelan SR		COPD; Hypertension; Atrial fib; History of breast cancer; History of basal cell carcinoma; Question of dysrhythmia; No known drug allergies; First dose of RSV or placebo and influenza vaccine administered on 10/17/02.		200400418	1						1	Chills; Condition aggravated; Cough; Dyspnoea; Lung disorder; Productive cough; Pyrexia; Respiratory failure	FLU3~SANOFI PASTEUR~U1137HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0217655	03/10/2004	PA	44.0	44		M	03/10/2004	Flu like symptoms, chills, shakes, sweats. Run down feeling, tired. Treatment, motrin, tylenol									U	03/06/2004	03/06/2004	0		UNK	UNK						1						1	Chills; Fatigue; Hyperhidrosis; Influenza like illness; Tremor	FLUX~UNKNOWN MANUFACTURER~765754~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~W1366~UNK~~LA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|UNK~UNKNOWN MANUFACTURER~C1262AA~UNK~~LA~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA		Influenza
0217751	03/11/2004	AK	31.0	31		M	03/11/2004	Patient had been asymptomatic following the myopericarditis, which developed on 3/27/2003, ten days following his smallpox vaccine. On November 18, 2003 he received his influenza vaccine and reports that with in 3 days he began to feel a general run-down feeling. At that time he also began to experience a discomfort in the left side of his chest. He describes this as pressure and rates the intensity as a 3/10. He reports that it has not been continuous, coming and going.  He initially did not think that the discomfort was related to the influenza vaccine or a repeat of his myopericarditis, due in part to the fact that the discomfort was not as intense as what was experienced on prior occasions. Therefore, he did not seek medical attention for approximately one month after symptoms began. He was seen by a doctor on January 7, 2004 at which time his ECHO was within normal limits with an ejection fraction of 68%.				Y					U	11/18/2003	11/21/2003	3	ECHO was within normal limits with an ejection fraction of 68%. Cardiac MRI normal	MIL	MIL	NONE	NONE	MYOPERICARDITIS FOLLOWING PRIMARY SMALLPOX VACCINE IN MARCH 2003.		AK200423	1						1	Chest pain; Condition aggravated; Discomfort; Fatigue	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0217666	03/12/2004	OK	68.0	68		M	03/11/2004	Injection was given Saturday morning, 11/2/02. Sunday night around 11 or so, started throwing up, fever diarrhea, chills, headache. He continued getting up, going to the restroom with the vomiting and diarrhea until about 10am Monday morning 11/4/02. He told my mom sometime later that he could not move his legs. I went to their house around 2:30 PM. Upon entering his room, he was laying in bed on top of the covers. I felt his foot and ankle, they were cool to the touch. I felt his back when he was trying to sit up and it was burning hot. His face was red. He was speaking. He wanted my son and I to help him get up. We were unable to lift him. I called a nurse friend of mine at 2:55 PM to have her stop by and take his blood pressure and kind of check him over. While I was on the phone with her, my mom yelled for me to call an ambulance. It took the ambulance about 5-10 minutes to get to their home. Dad was speaking to the paramedics, telling them what all was going on. They loaded him into the ambulance and he was still alert and speaking. Somewhere in the 2-3 minute trip to the emergency room, my dad died. Upon entering the emergency room, they had made it a code blue call and continued working on him. The ER doctor worked on dad until 6:00 PM when he was life flighted to another hospital. He was taken to ICU where we were told by the doctors they did not know if he would make it through the night. He was in ICU for 7 days. The doctors ran several tests. During this time, we learned that he had become paralyzed from the waist down, he had a spinal stroke, a head stroke and they were not sure if any damage had been done when he actually died (lack of oxygen to the brain). After 2 weeks in the hospital, dad was moved to a rehab center, from there to a skilled nursing facility and from there, home. Over the next 8.5 months, dad was in and out of the hospital. The longest time between hospital stays was 35 days. On 7/1/03, dad was taken to the hospital for fever. He had a UTI. He was in the hospital for about 10 days and they could not figure out why he kept running a fever at night. He was transferred to another hospital. He was given an injection and it reacted with the medication they had him on, he went into rigors, had a massive heart attack and died on 8/4/03. The death certificate received on 3/23/04 states pontine stroke and pneumonia.	Y	08/04/2003		Y	Y		Y	Y	N	11/02/2002	11/03/2002	1		PVT	OTH	Cholesterol; Blood pressure; Blood thinner; Water pill	NONE	HBP; Retroperiteneal fibrosis; High cholesterol; Swelling of the leg			1						1	Cerebrovascular accident; Chills; Diarrhoea; Erythema; Headache; Myocardial infarction; Paralysis; Peripheral coldness; Pneumonia; Pyrexia; Urinary tract infection; Vomiting	FLU3~SANOFI PASTEUR~V0929AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0217697	03/12/2004	OK	66.0	66		F	03/11/2004	Injection given Saturday morning 11-2-02, Monday night started vomiting, fever, aches, diarrhea, chills. In bed 5 days. Called doctor, called in prescription.				Y					Y	11/02/2002	11/04/2002	2	NONE	PVT	OTH	Blood pressure, premarin	NONE	Fibromyalgia, arthritis, high blood pressure, colon cancer.			1						1	Chills; Diarrhoea; Pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~V0929AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0217698	03/12/2004	NV	68.0	68		M	03/11/2004	After receiving pneumonia/ pneumococcal vaccine, his right arm started swelling about 6 hours later Saw 1 hour physician.				Y					Y	03/10/2004	03/10/2004	0		PUB	UNK		NONE	CABG O2, Ca. Radiation			1						1	Oedema	FLU3~SANOFI PASTEUR~U1093AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0947N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0217699	03/12/2004	PA	10.0	10		F	03/05/2004	Fever greater than 102, arm sore, myalgia's (moderate).				Y					U	03/03/2004	03/04/2004	1		PVT	UNK	Lantus / Humalog	NONE	Keflex Allergy, Type I DM.			1						1	Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1267AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1179N~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0217700	03/12/2004	GA	62.0	62		F	02/11/2003	Client seen by nurse practitioner at clinic 2-11-04 - client stated that shortly after she received both injections her arms became red and swollen. Continues to complain of tenderness to touch and pain on movement especially lifting over head- minimal swelling. Afebrile.									U	11/10/2003	11/10/2003	0	UNK	PUB	PUB	Paxil, Enalapril, Zantac, Metformin.	UNK	COPD, GERD, HTN, Type 2 DM, Depression, Hypercholesterolemic.		GA04005	1						1	Erythema; Hypokinesia; Oedema; Pain; Tenderness	FLU3~SANOFI PASTEUR~U1089AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~AVENTIS PASTEUR~U0831AA~2~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0217754	03/12/2004	PA	34.0			M	03/31/2004	This report of dermal hypersensitivity reaction and rash is being submitted in an expedited time frame as requested by the FDA. Information regarding Flumist nasal solution was received from a healthcare professional regarding a 34 year old male patient who experienced an explosive itchy red maculo-papular rash. The patient received the first dose on 1/10/04. The patient's concurrent illnesses include depression and psoriasis. Indication for Flumist was immunization. Product was administered on 1/10/04. Dose regimen was 1 dose. Additional suspect medication included Wellbutrin. On 1/16/04 the patient developed a dermal hypersensitivity reaction characterized by an explosive itchy, red maculopapular rash on his palms, fingers, arms and one ankle. The rash was thought to be erythema multiforme and the patient was treated with a dose of Celestone. He was continued on steroids until 1/22/04. The reporter also indicated that the patient started Wellbutrin on 12/22/04; it was discontinued on 1/22/04. The rash resolved on 2/15/04.  Test results: Hinkology (results: Microscopic description: histologic features are most consistent with those of a dermal hypersensitivity reaction possibly related to a medication or arthropod assault) was done in 2004. No additional information was available at the time of this report.									Y	01/10/2004	01/19/2004	9	Histology (results: microscopic description: histologic features are most consistent with those of a dermal hypersensitivity reaction possibly related to a medication or arthropod assault) was done in 2004.	PVT	PUB	Wellbutrin XL	UNK	Depression; Psoriasis		HQWYE393926FEB04	1						1	Hypersensitivity; Pruritus; Rash maculo-papular	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0217803	03/12/2004	MO	42.0	42		F	03/12/2004	I am unsure of the exact date adverse events began, but I did call my MDs office to report problem on 11/14/03. The problem consisted of pain and numbness of the left arm,elbow,and hand. Vaccine was administered in left arm. I felt two tracts one down the front of my arm into 1st and 2nd fingers which became numb. The other pain radiated behind my arm near elbow and to pinkie finger. I had pain at the injection site radiating down. Doctor recomended OTC anti inflamitories. I visited 3 chiropractors. He did spinal adjustment and recomended oral echinacea. The other doctors did adjustment and Massage to effected areas. Doctor did adjustment on two occasions which finally yielded relief of numbness of the arm hand. I continue to experience pain at the elbow especially when I lift my arm away from my body and at top of the forearm. worsening this week. (menstral time) for which I am taking 600-800mg ibprophen every 4-6 hours.									N	11/07/2003	11/11/2003	4	My MD did not think the problem was related to the vaccine. I have a history of neck and shoulder pain on the left side. But it was always localized (no radiating pain or numbness) until after vaccine was given. I am treated for major depression impipramine 300mg daily, alprazolam 0.5mg x 2 daily, ibprophen prn pain neck shoulder (usual dose prior 200-400 mg) once or twice a day when needed, cyclobenzaprine 10 mg one tablet three times a day was started at the visit the vaccine was given for muscle spasm in neck. It wasnt very effective and made me tired I preferred chiropractic relief.	PVT	UNK	see lab data above	see lab data no other illness present	see lab data above NKA			1						1	Hypoaesthesia; Injection site pain; Pain	FLUX~UNKNOWN MANUFACTURER~u1264aa~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0217805	03/12/2004	AZ	19.0	19		F	03/12/2004	Headache, lower back pain, nausea, vomiting, loss of unborn child. Lasted for two weeks; resulted in hospitalization. Nurse follow up on 05/18/04: spontaneous rupture of membranes.				Y	Y	3			Y	11/20/2001	11/22/2001	2	WBC elevated, lab test abn	UNK	UNK	NONE	NONE	Group B streptococcus UTI;		AK200424	1						1	Abortion; Back pain; Headache; Laboratory test abnormal; Nausea; Vomiting; White blood cell disorder	FLUX~UNKNOWN MANUFACTURER~Unknown~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0217764	03/15/2004	CA	77.0			M	02/28/2004	Admitted to hospital for possible seizure in physician's office after receiving the flu vaccine (brand unknown). Discharge summary states constipation, dyspnea, asphagia. msv					Y	2			Y	10/28/2003	10/28/2003	0	Discharge summary states hyperglycemia. msv Medical records state abnormal lab tests. msv	PVT	PVT		NONE	Discharge summary states diabetes mellatus, abnormal kidney function, hypertension, coronary artery disease, hyperlipedemia, allergy, lung disorder. Medical records states gastritis, cerebrovascular disease. msv			1						1	Aphasia; Constipation; Convulsion; Dyspnoea; Hyperglycaemia; Laboratory test abnormal	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0217769	03/15/2004	KY	1.0	1	.0	F	01/23/2004	Severe rash, extremity and forehead swelling rash consistent with urticaria vs erythema multiforme arising 3 days after initiation of Amoxil (2nd course since birth).				Y					U	01/14/2004	01/18/2004	4		MIL	MIL	Amoxicillin	Right Otitis Media,  Diagnosed 1/14				1						1	Erythema multiforme; Oedema; Rash; Urticaria	FLU3~SANOFI PASTEUR~U1172M~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0450~3~~~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0134N~1~~~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|VARCEL~MERCK & CO. INC.~0830N~1~~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0217770	03/15/2004	MD	55.0	55		F	02/26/2004	Employee complains of pain right deltoid since vaccination- 10/28/2003. Complained of pain at rest and upon use of right arm. Has take Ibuprofen with relief, but pain returns when medication not taken.									U	10/28/2003	10/28/2003	0		PVT	PVT		UNK	Iodine.			1						1	Pain	FLU3~EVANS VACCINES~75705~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0217858	03/15/2004	AL	38.0	38		M	03/15/2004	T.C. from clients mother. Stated client had pain in left deltoid the day after vaccine 11/1/03.   Mother stated to wait and it would get better.  At one point ( not knoen) client thought pain was better, however he now states to mother that it is very painful at site of injection and it hurts when patient lays on his left side and also when he lifts weights. He is thinking about seeing a physician. Client has moved.									U	10/31/2003	11/01/2003	1		PUB	PUB	none	no	none			1						1	Hypokinesia; Injection site pain; Pain	FLU3~EVANS VACCINES~765852~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0217865	03/15/2004	MN	53.0	52		F	03/15/2004	Within 20 minutes developed pain in left arm. Now have weakness in hand grip and left arm, and pain that continues for many years since this vaccination.  Ultrasound and electronic stimulation were tried and beneficial. Medical records state hypertension, tendon disorder. msv				Y				Y	N	11/29/2000	11/29/2000	0	EMG in 2001 on left arm normal.  Blood tests normal in 2001.	UNK	UNK	None	None	NoneMedical records state allergy. msv	Headache with visual changes~Influenza (Seasonal) (no brand name)~1~0.00~In Patient		1						1	Hemiparesis; Hypertension; Pain; Tendon disorder; Blood pressure increased; Muscular weakness; Pain; Sleep disorder; Tendonitis	FLU3~MEDEVA PHARMA, LTD.~E70200KA~3~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~E70200KA~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Disabling	Influenza
0217809	03/16/2004	CA	56.0	56		M	03/08/2004	Patient developed Guillain Barre Syndrome with typical clinical presentation. Received IVIG treatment. The medical record received on 4/5/04 states numbness, tingling, weakness, pain in back, paraesthesia, atrophy of muscle, lower extremities, hoarseness and orthstatic hypotension.				Y	Y	5			N	10/16/2003	11/06/2003	21	CSF lab results were consistent with Guillain Barre Syndrome. CSF protein elevated, EMG+ changes.	PVT	PVT	NONE	NONE	Hypertension, PAT, sleep apnea			1						1	Asthenia; Back pain; CSF test abnormal; Dysphonia; Guillain-Barre syndrome; Hypoaesthesia; Hypotension; Muscle atrophy; Guillain-Barre syndrome; Hypoaesthesia; Muscular weakness; Paraesthesia	FLU3~EVANS VACCINES~765484~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~EVANS VACCINES~765484~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Hospitalisation	Influenza
0217810	03/16/2004	TX	71.0	70		M	03/04/2004	Pt complains of severe pain in his right arm. Pt claims pain caused by immunization received on 10/3/03.									N	10/03/2003	10/03/2003	0	NONE	PUB	OTH	NONE	NONE	NONE		TX04011	1						1	Pain	FLU3~SANOFI PASTEUR~U1092AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~AVENTIS PASTEUR~U0522A2~2~~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0217811	03/16/2004	KS		42		F	03/10/2004	R arm very sore from 10/20/03 after flu shot until end of December 2003. On Aleve x 5 days. On Prednisone 10mg 5, 5, 4, 4, 3, 3, 2, 2, 1, 1. Deltoid inflammation.									Y	10/20/2003	10/20/2003	0		PVT	PVT	NONE	NONE	NONE			1						1	Injection site inflammation; Injection site pain	FLU3~SANOFI PASTEUR~U1267AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0217812	03/16/2004	KS	32.0	32		F	03/10/2004	R arm very sore from 10/22/03 post shot until end of January, 2004. Pt took Aleve 500mg in am and 400mg at for x 5 days then took Prednisone 10mg. 5, 5, 4, 4, 3, 3, 2, 2, 1, 1, then had physical therapy x 6. Inflammation/ irritation in tendon of R lateral deltoid region.									Y	10/22/2003	10/22/2003	0		PVT	PVT	Mercette	NONE	NONE			1						1	Injection site inflammation; Injection site pain; Skin irritation; Tenderness	FLU3~SANOFI PASTEUR~U1267AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0217813	03/16/2004	KS	47.0	47		F	03/10/2004	R arm very sore after flu shot on 10/13/03. On Motrin x 14 days, Prednisone 10mg 5, 4, 3, 2, 1. Inflammatory response.									Y	10/13/2003	10/13/2003	0		PVT	PVT	Premarin					1						1	Injection site inflammation; Tenderness	FLU3~SANOFI PASTEUR~U1267AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0217814	03/16/2004	FL	32.0	32		M	12/12/2003	Increasing erythema and temp circumference around and down arm to elbow and approximately 2 inches into the forearm.				Y					U	12/10/2003	12/11/2003	1		MIL	MIL		NONE				1						1	Erythema; Feeling hot	ANTH~EMERGENT BIOSOLUTIONS~FAV07~7+~~RA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~765747~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0217869	03/17/2004	VA	67.0	66		F		This subject is a 67 year old female who was admitted to the hospital due to labored breathing while enrolled in a study. The subject received 2 doses of RSV vaccine or Placebo and Influenza vaccine with the last dose administered on 10/22/03. The subject presented with labored breathing on 2/21/04, 122 days post immunization and was admitted to the hospital on the same day. The causality has not been assessed by the investigator. Additional info has been requested. Additional info received on 3/1/04. The laboured breathing was assessed by the investigator as unrelated to the study vaccine. Outcome is unknown at this time. Additional info received 3/9/04. Subject was admitted to hospital on 2/21/04 with acute cholecystitis, septic shock, CHF, respiratory failure, labored breathing. Subject was on a respirator. Subject died on 3/5/04, 13 days after admission and 135 days post immunization. Additional info received 3/10/04. Subject received first dose of RSV or Placebo and Influenza vaccine on 10/31/02. Additional info received on 3/11/04. The acute cholecystitis, septic shock, CHF, respiratory failure were reported by the investigator as unrelated to the study vaccine. The death certificate received on 3/22/04 states COPD. The medical record received on 3/22/04 states neuropathy, GERD, ulcers and hypothyroidism. The hospital discharge summary received on 3/23/04 states hypotension, SOB, decreased po intake and elevated liver enzymes. Follow up on 03/24/04: Copy of death certificate: Cause of death: Sepsis syndrome-cholecystitic. Other significant conditions contributing in death but not resulting in the underlying cause of death is advanced COPD.	Y	03/05/2004			Y	14			N	10/22/2003	02/21/2004	122		UNK	UNK	RSV/ Placebo		Information from follow up 3/10/04: received first dose of RSV or Placebo and Influenza vaccine on 10/31/02. Asthma; CHF		200400770	1						1	Anorexia; Cardiac failure; Cholecystitis; Dyspnoea; Gastric ulcer; Gastrooesophageal reflux disease; Hypotension; Hypothyroidism; Liver function test abnormal; Lung disorder; Neuropathy; Respiratory failure; Sepsis; Shock	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0217917	03/18/2004	DC	51.0	52		F	03/15/2004	Chronic sinusitis & new diag. nasal polyp following influenza vaccine.									N	10/21/2003	10/22/2004	367	NONE	MIL	MIL	Avalide 1 Tab qd	NONE	hTN, Seasonal allergies			1						1	Nasal polyps; Sinusitis	FLU3~SANOFI PASTEUR~U1098AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0217930	03/18/2004	FL	38.0	38		F	03/05/2004	Arthralgia. This case was reported by a nurse practitioner and described the occurrence of generalized arthralgia in a 38 year old female patient who received hepatitis A inactivaed & hepatitis B recombinant vaccine (Twinrix). On 04 February 2004 the patient received the 1st dose of Twinrix. On the same day, the patient received injections of Influenza virus vaccine (manufacturer unknown), Typhoid vaccine (Typhim Vi, Aventis Pasteur), inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur), and Tetanus and diptheria toxoid vaccine (Aventis Pasteur). Approximately four days later on 08 February 2004, the patient experienced generalized arthralgia. The patient was treated with ibuprofen (Advil) without relief. As of 10 Febrary 2004, the event remained unresolved.									U	02/04/2004	02/08/2004	4	UNK	PVT	PVT		UNK	The patient's medical history, concurrent conditions and concurrent medications were not reported.		A0497599A	1						1	Arthralgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~HAB276A6~1~~~HEP A + HEP B (TWINRIX)~1|IPV~SANOFI PASTEUR~~UNK~~~POLIO VIRUS, INACT. (IPOL)~1|TD~AVENTIS PASTEUR~~UNK~~~TETANUS DIPHTHERIA (NO BRAND NAME)~1|TYP~SANOFI PASTEUR~~UNK~~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0217976	03/18/2004	TX	26.0	26		M	03/18/2004	Patient (pt) is a 26 year old male who received both typhoid and flu vaccine on 23-10-03. He felt fine the first wk and then at the end of October he had a knot in his throat, bad taste in his mouth and throat pain. Went to the doctor and was given amoxicillin for Strept- throat. States that the amoxicillin helped his throat. One week after the amoxicillin he started to notice a problem with blurred vision, dizziness and problems with balance. States it was constant and not associated with activity. Because of the dizziness and problems with his balance he was having problems playing basketball. Also had a headache. Described as constant, hurting bad and located in the frontal area of his head. Never had headaches like this before. He returned to the medic and was given meclizine for the dizziness. He tried it for 1 wk without any improvement so he returned to clinic. The clinic arranged for him to go for a MRI and further evaluation. MRI  revealed a cerebellar lesion vs. demyelinating disease. He was then given steroids and pt noted improvement in dizziness and stated that his blurred vision cleared. States headaches went away when his vision improved. Pt arrived at hospital on Dec 23 and stated he was taken off his steroids. While at home on Jan 2, 2004 he had a seizure witnessed by his cousin. Pt reported that his cousin said that he started shaking and fell to the floor. Pt did bite his lip. No incontinence noted and pt has no recall of event.  Pt was transported where he was admitted for evaluation. Pt states he has no prior history of seizures.  Hospital records indicated that when he was admitted he had mental status changes with combative behavior and a fever of 102.8. Intubation was required to complete medical workup. Initially started on Rocephin, Vancomycin and Acyclovir for empiric treatment of meningitis. Because blood and CSF were negative, the antibiotics were discontinued. Pt was discharged on January 7, 2004 with a normal gait, strength and appropriate mental status. Follow up as out patient with repeat MRI and Cerebral Spinal Fluid Analysis. March 18, 2004: Pt states he is doing well and feels there is an improvement in his condition. Only problem now is that he has occasional spasms on his right side of his body lasting 5-10 seconds. Spasms do not interfere with activity and he is not falling. He also complains of brief periods of dizziness during spasms. He is now hoping to resume some form of physical activity. Nurse follow up on 05/18/04: Cerebellar lesion, nystagmus, ataxia.					Y	7			U	10/23/2003	11/07/2003	15	MRI March 15 2004-IMPRESSION: 1. STABLE IMAGING FINDINGS, WITHOUT EVIDENCE OF PROGRESSION OF DISEASE OR ENHANCEMENT.  2. ELEVATION OF CHOLINE RELATIVE TO CREATININE, WITHOUT SUPPRESSION OF NAA.  FINDINGS REMAIN NONSPECIFIC.  MAJOR DIFFERENTIAL CONSIDERS REMAIN TUMOR VERSUS DEMYELINATING DISEASE. Nurse follow up 05/18/04: EEG abnormal.	MIL	MIL	denies	denies	denies			1						1	Aggression; Bacterial infection; Balance disorder; Convulsion; Coordination abnormal; Delirium; Dizziness; Dysgeusia; Electroencephalogram abnormal; Headache; Injury; Laboratory test abnormal; Mental impairment; Muscle spasms; Nystagmus; Pharyngolaryngeal pain; Pyrexia; Tremor; Vision blurred	FLU3~SANOFI PASTEUR~U1147AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~SANOFI PASTEUR~U0704~2~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Hospitalisation	Influenza
0217941	03/19/2004	WV	73.0	73		F	03/11/2004	Clients states she developed a small, red, raised rash on trunk, upper arms and upper legs about 24 hrs post taking an influenza vaccine. The rash persisted until mid Feb/04 and was very uncomfortable  severe itching. Client saw her private doctor, no treatment given doctor didn't know what it was per client.				Y					Y	10/28/2003	10/29/2003	1	NONE	PUB	UNK	UNK	NONE	UNK		WV0316	1						1	Rash erythematous; Rash pruritic	FLU3~SANOFI PASTEUR~U1268AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0217942	03/19/2004	CA	59.0	59		M	03/17/2004	Client received flu shot on 11/18/03 at health department at approximately 11:00 AM. Cient states that after receiving vaccine his arm was sore. Since 11/13/03. Client states that left arm is weaker than right arm and is unable to carry heavy objects with left arm. Limited range of motion of left arm. He also states that he experiences a tingling sensation down his left arm at times.									U	11/18/2003	11/18/2003	0	NONE	PUB	MIL	Glucophase, Glucontrin		Diabetes-controlled with meds mentioned above + diet			1						1	Joint range of motion decreased; Muscular weakness; Paraesthesia	FLU3~EVANS VACCINES~765143~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0216896	03/22/2004	FL	18.0	18		F		A report was received from a non health care professional (vaccinee's mother) concerning an 18 year old female vaccinee who developed symptoms of an upper respiratory infection 4-5 days following vaccination and Bell's Palsy 9 days following vaccination which resulted in hospitalization after receiving Fluvirin on 1/23/04. The vaccinee developed symptoms of an upper respiratory infection 4-5 days following administration of Fluvirin. On 2/1/04 the vaccinee developed slurred speech and experienced paralysis of the left side of her face. The vaccinee was taken to the local hospital emergency department where she was treated with prednisone and acyclovir and subsequently diagnosed with Bell's Palsy. The vaccinee was seen by her neurologist on 2/5/04 who confirmed that she had Bell's Palsy. The vaccinee's symptoms have improved but her left eyelid does not close properly. Follow up pending. Follow up received 08Jul04 from Healthcare Professional, confirming that this 18 year old female vaccinee had received Fluvirin on 23Jan04 and had developed Bell's Palsy on 01Feb04, she was treated with Acyclovir 200mg 5 times daily and Prednisone 20mg twice daily. There were no other known concomitant medications. The outcome of the event is unknown. The vaccinee's father has a history of multiple sclerosis. The reporter considers that this event is possibly related to Fluvirin.					Y			Y	U	01/23/2004	02/01/2004	9		UNK	UNK			Father has Multiple Sclerosis		PJP200400154	1						2	Dysarthria; Face oedema; Facial palsy; Headache; Lacrimation increased; Rhinorrhoea; Tongue paralysis; Dysarthria; Facial palsy; Upper respiratory tract infection	FLU3~EVANS VACCINES~765971~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~EVANS VACCINES~765971~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Hospitalisation,Disabling	Influenza
0217992	03/22/2004	CA	75.0	75		F		This subject is a 75 year old female who was admitted to the hospital due congestive heart failure while enrolled in a study. The subject has received two doses of RSV vaccine or Placebo. Administration dates not reported. The subject developed moderate congestion with fluid build up in her lungs and was admitted to the ICU with a diagnosis of congestive heart failure on 2/8/04. Subject's sodium was also low at 106. The congestive heart failure was reported by the investigator as life threatening and not related to the study vaccine. Additional info received on 2/13/04. Subject received two doses of RSV vaccine or Placebo and Influenza vaccine with the last dose on 10/24/03. Dates of first dose 10/31/02. Subject developed congestive heart failure 94 days post immunization and was admitted to the hospital on 1/26/04, was transferred to the ICU on 2/8/04. Subject remains in ICU. On 1/12/04 breathing tube and feeding tube were removed. She is breathing well on her own. X-rays are being done daily and she is still on IV antibiotics. Seriousness not reported. Subject is recovering and will continue in the study. Additional info 2/20/04. The congestive heart failure was reported by the investigator as life threatening and not related to the study vaccine. Additional info received on 2/20/04. Subject was released from ICU and returned to the regular medical floor. She complained of dysphagia and difficulty with speech since feeding tube and breathing tube were removed and is mildly disoriented (responsive to commands). The subject is recovering and will continue with the study. Additional info received 2/27/04. Diagnosis: A-fibrillation, severe aortic stenosis, severe cardiac and bronchial asthma with congestive heart failure. Echo report on 2/9/04: Impression 1. Calcified degenerative aortic valve disease with moderate aortic valve stenosis with estimated aortic valve area of 0.9 cm squared and mean gradient of 24MMhg. 2. Mild bi-atrial enlargement, normal left ventricular size with hyperdynamic left ventricular hypertrophy.3. There is evidence of left ventricular diastolic dysfunction, moderate aortic valve stenosis, aortic valve of 0.9cm squared. Mild mitral and tricuspid valve insufficiency and mild pulmonary hypertension by doppler. Subject's breathing is extremely poor and is scheduled to have a tracheotomy and feeding tube inserted. She has been non verbal for the past 2 1/2 weeks, but seems to hear and comprehend better now. Mucus is being flushed from her lungs every 24 hrs. Resistant to massive doses of corticosteroids. Additional info received on 3/1/04. Tracheotomy was performed on 2/27/04. A gastric feeding tube was also scheduled to be inserted however she is on Coumadin and her bleeding time was too high to have procedure done. It will be performed once her bleeding time is controlled. Investigator has assessed the event as life threatening, unrelated to the study vaccine. Additional info received on 3/9/04. Gastric feeding tube placed, date of procedure unknown. Subject was extubated and receives breathing treatments every 4 hrs. She remains nonverbal and can now swallow. Antibiotic therapy continues. Subject has started antidepressants as well as Coumadin. Subject's blood sugars have been elevated and Insulin is being administered prn. Subject's recovery is ongoing and has been discharged to a long term acute care hospital (exact date not reported). Additional info received 3/15/04. Subject expired on 3/12/04, 140 days post immunization while in the acute care hospital. Diagnosis: Congestive heart failure. Awaiting death certificate. The subject's death due to congestive heart failure was assessed by the investigator as unrelated to the study vaccine.  Additional information received Mar 29, 2004. Discharge summary from Jan 30, 2004 to Feb 7, 2004 Discharge Diagnosis: The patient status post L2 through L 5 laminectomy and decompression performed. 1.The patient is mediclaly and surgicaly stable postop. 2. Patient with evidence of atrial fibrillation as well as signifant pulmonary deficits at the time, transferred to the acute medical service for stabilization. Patient also noted to have hyponatremia at the time. Hospital course: The patient was begun on intensive physical and occupational therapies as well as utilizing speech and nursing services for all of her deficits. During the hospitalization, the patient made good progress in her rehabilitation. The patient however did have low sodium level which at its lowest point was at 108. She also had evidence of some mild respiratory distress on the 7th of February. The patient was evaluated by the medical service and subsequently was tranferred to the medical service secondary to atrial fibrillation as well as some respiratory distress and significant hypoatremia was noted. Disposition: The patient ws transferred to the acute service on the 7th of February. Additional ifnromation received 7 April 2004. Jan 26, 2004: Admitted to hospital for elective spinal surgery. Feb 7, 2004: Discharge from rehab to ICU. Feb 17, 2004: Discharge from ICU to acute care (hospital floor). March 5. 2004: Discharge from hospital and transferred to acute care facility. March 12, 2004: Subject expired at acute care facility. 8 April 2004- Upon internal review from information received on 29 March and 7 April the subject's hospitalization for spinal surgery due to antero-spondylalisthesis and lumbar spinal stenosis will be combines into report 2004-00471. The subject was admitted to the hospital for elective surgery on 26 January 2004, 94 days post immunization. Subject had an MRI (date not reported) of the lumbar spine which showed severe spinal stenosis at the L4-5 level, with evidence of severe ligamentum hypertrophy at the lumbar spine resulting in lateral recess and neuro foraminal stenosis. She underwent a bilateral L2, L3, L4, L5 laminectomy with exploration/decompression L2-3, L3-4, L4-5, L5-5 neuro foramen. Additional information received on 4/14/04: Follow up report and Death Certificate. Subject wa originally diagnosed with Congestive Heart Failure however developed Pneumonia which led to Sepsis. Sepsis was the final cause of death which was secondary to Pneumonia, organism unspecified CU. Additional information received 4/29/04 Discharge summary report for admission to ICT on 2/7/04 and discharged from ICU to Acute care facility 3/5/04. Discharge Diagnosis: 1) Lumbar laminectomy post-operative day 40. 2) Severe hyponatremia, which has resolved. 3) Ventilator-dependent respiratory failure. 4) Severe chronic obstructive pulmonary disease, FEV 1.0 L, which is 50% of predicted, FVC 1.93, 70% of predicted. 5) Atrial fibrillation. 6) Moderate to severe aortic stenosis. 7) Myopathic neuropathy syndrome. 8) Hyperlipidemia. 9) Hypertension. 10) Osteoporosis. 11) ALBUTEROL allergy and possibly AMPICILLIN allergy. 12) Obstructive sleep apnea syndrome. 13) Anemai. 14) Thrombocytopenia. 15) Candida-albicans in sputum. 16) Mild hyperglycemia/diabetes mellitus 2. 17) Tracheostomy post-operative day 6 and percutaneous endoscopy gastrostomy tube post operative day 1. Discharge medications: Diflucan, Verapamil, Zovirax, Prevacid, Xopenex, Solu-Medrol, Atrovent, Free water, Bacitracin ointmen, Trach collar 30% as tolerated, Ventilator, Tylenol, Regular Insulin sliding scale. Subject was aformentioned diagnosis 40 days ago was seen when she had  change in mental status and respiratory insufficienty. She was transferred urgently for these complaints to the intensive care unit, and she was found with a sodium of 109. She was intubated and treated agressively. Her sodium was gently repleted to the normal levels. SHe has had difficulty with her cardiopulmonary status, particularly respiratory failure requiring Bi-PAP. Tracheostomy was performed six days ago and a PEG-tube was placed for nutrition. Patient had slight atelectasis in the left lower lobe which was likely due to the fact that she has been breathing spontaneously on Trach collar, but not taking deep breaths. Treated with a ventilator at night per the aforementioned settings. Subsequent medical care under the supervision of doctor. The family has been informed of diagnosis and prognosis. Details of the case has been discussed with the patient's son. A cardiology consultation should be obtained to optimize cardiopulmonary status, management of aortic stenosis and atrial fibrillation. Coumadin anticoagulation should be re-initiated.	Y	03/12/2004	Y		Y	46			Y	10/24/2003	01/26/2004	94	Sodium 106. Information from f/u received 3/9/04-elevated blood sugars	UNK	UNK	RSV/ Placebo; Azmacort, Verapamil, Fosamax, Uniphyl, Nasacort, Ventolin, Diovan HCT, Accolate, Premarin, baby aspirin, Zocor, Vioxx, Xopenex, Duratuss, Darvocet-N, Forodil, Valtrex, Cipro, Fluconazole, KCL, sodium chloride flush, multivitam		COPD, emphysema, interstitial lung fibrosis. Allergies: ampicillin, fresh paint, air freshener, cleansers with strong odor, perfume, aeromed		200400471	1						1	Aortic valve stenosis; Asthma; Atrial fibrillation; Blood glucose increased; Blood sodium decreased; Cardiac asthma; Cardiac failure; Cardiomegaly; Cardiovascular disorder; Disorientation; Dysphagia; Dyspnoea; Hyperglycaemia; Hypertrophy; Hypoxia; Pulmonary hypertension; Pulmonary oedema; Respiratory distress; Sepsis; Speech disorder	FLU3~SANOFI PASTEUR~U1137HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0218004	03/22/2004	WI	23.0	23		F	10/15/2003	Acute anaphylactic - IV Benadryl and Salumedrol per mouth Zyrtec. Symptoms resolved.  Nurse follow up on 06/18/04 states: Flushed, itching, puffy eyes, anxiety, Tachypneic.				Y					Y	10/14/2003	10/14/2003	0	NONE	OTH	PVT	NONE	NONE	Mood disorder; Migraine; Allergy;		WI0310	1						1	Anaphylactic reaction; Anxiety; Eyelid oedema; Flushing; Pruritus; Tachypnoea	FLU3~SANOFI PASTEUR~U1095AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0218005	03/22/2004	NY	51.0	51		F	03/12/2004	Deep aching pain in elbow joint with pain radiating in upper and lower arm with weakness and swelling in elbow joint area and arm (left arm).				Y					N	12/15/2003	12/19/2003	4	NONE	PUB	OTH	NONE	NONE-Just time for Tetanus;	Hypertension; Pulmonary Ambolism; Sinusitis; Acid Reflux Disease; Microvalve Prolapse, Allergy;			1						1	Arthralgia; Injection site oedema; Injection site pain; Muscular weakness; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~AVENTIS PASTEUR~U1D00AF~UNK~~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0218076	03/22/2004	NC	80.0			M	03/22/2004	On 1/2/04 pt states that he fell at home and he felt like I lost balance and strength in my arms and legs. Pt was able to get to the phone and call 911. Was taken to the ER. Nurse follow up on 05/18/04 states: confusion, reflexes absent, sensory loss. Nurse follow up on 05/18/04 states: UTI:Infect Urinary Tract, CAD, Hypercholesterolemia, Osteo-arthritis (Cardiovasc Dis, Hypercholester, Arthritis).			Y	Y	Y	7		Y	U		01/03/2004		Diagnosis of Guillain Barre syndrome.  Nurse follow up on 05/18/04 states: EMG abnormal;	UNK	UNK	pt was on glyburide, atenolol and aspirin at time of vaccination	no	Diabetes and Hypertension; allergy			1						1	Arthritis; Balance disorder; Cardiovascular disorder; Guillain-Barre syndrome; Hypercholesterolaemia; Hyporeflexia; Laboratory test abnormal; Muscular weakness; Paraesthesia; Urinary tract infection	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0218031	03/23/2004	MI	66.0	66		F		Nausea/ vomiting/ dehydration/ malnutrition/ hypotention/ severe/ all required hosp still numbness/ left side/ instability walking-blood pressure. The discharge summary received on 3/31/04 states weakness, blurred vision, headache, photophobia and GI reflux. The medical record received on 3/31/04 states weight loss, and hypokalemia. Information from Annual Follow-up report states permanent disability/nerve damage, numbness left and right side.				Y	Y	20			N	10/21/2003	10/24/2003	3	CT scans/ ultrasounds/ blood/ MRI's/ EMG etc. Lab values abnormal.	PVT	PVT		NONE	Mild case lupus, hypertension, fatty liver, ascites			1						1	Amblyopia; Asthenia; Dehydration; Gait disturbance; Gastrointestinal disorder; Headache; Hypoaesthesia; Hypokalaemia; Hypotension; Laboratory test abnormal; Nausea; Photophobia; Vomiting; Weight decreased	FLU3~SANOFI PASTEUR~U1145AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0218034	03/23/2004	VA	79.0	79		M	11/02/2003	Patient with history of dementia, CVA's, and a fib received an influenza vaccination at this private MD's office in the morning. That night he came to ER with mental status changes and low grade fever. Spouse stated that patient didn't seem his baseline that morning prior to receiving influenza vaccine. Patient admitted for observation 11/1/03. Discharged 11/3/03, family states patient is back to normal baseline. Medical record states dehydrated. msv				Y	Y	2			Y	10/31/2003	10/31/2003	0	All cultures negative	PVT	OTH	Dlanzapine 2.5mg bid prn; Simvastatin 20mg hs; Cyanocobalwin 1000mcg qd; Bumetanide 2mg qd; Verapamil 80 mg bid; Doxepin 25mg hs; lisinopril 40mg qd	NONE	Long term use anticoagulants; arteriosclerotic CVD; history CVA; dementia; HTH; A fib; History of CHF Discharge summary states hyperlipedemia. Medical records states hypertension, urinary incontinence. msv			1						1	Dehydration; Mental impairment; Pyrexia	FLU3~EVANS VACCINES~765956~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0218035	03/23/2004	MI	48.0	48		F	11/20/2003	Client called on 11/-20-03 with a c/o chills, fever, muscle aches, muscle cramps, headache and weakness in which she experienced on 11-19-03 at 11pm. PHN advised client to follow-up with physician. Client states she does NOT plan to follow-up with her physician.				Y					U	11/19/2003	11/19/2003	0		PUB	PVT	Fosamax	NONE			MI2004015	1						1	Asthenia; Chills; Headache; Muscle spasms; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1089AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0218036	03/23/2004	MI	37.0	36		F	12/26/2004	Upon receiving flu vaccine on 12-23-03 client felt burning sensation all the way down left arm. That evening she developed pain in the in the joints of her left shoulder and left wrist. Over the last couple of days it has gotten progressively worse now migrating to elbow. No relief with 800 mg Motrin. 1-8-04 client called and spoke with clinic nurse, states arm feeling better and she never followed up with physician.									N	12/23/2003	12/23/2003	0	1-27-04 follow up call and message left.	PUB	UNK		NONE	Only environmental allergies		MI2004014	1						1	Arthralgia; Skin burning sensation	FLU3~SANOFI PASTEUR~U1293AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0218037	03/23/2004	MI	73.0	73		M	11/05/2003	4 days after flu vaccine noted on underside of left arm a painless rash, raised, blistered but now crusty burning eyes- red & draining- client telephone call to doctor- prescibed Clarinex 1 every day has been taking for several days with no relief- public health nurse referred back to doctor- will call today for appointment. Public health nurse telephone call 11/12/03 client saw doctor cortisone shot and pills. No current problems.				Y					N	10/21/2003	10/25/2003	4		PUB	UNK		NONE	Diabetes		MI2004012	1						1	Blister; Eye discharge; Eye irritation; Rash	FLU3~EVANS VACCINES~765852~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0218087	03/24/2004	FL	41.0	41		F	03/18/2004	1st fever noted eve of 3/16/04 the next day noted redness & warmth at site of injection right arm not deltoid. Following day area of redness was larger and fever come & go- chills & sweating, feels achy- headache. Taking Tylenol.									N	03/16/2004	03/16/2004	0	Treatment- Pt given Triamcinolone, oint 0.19 to apply twice a day- Ice. Ibuprofen 400 mg twice a day.	OTH	PVT	Prevacid, Glucophage, Monopril/Hetz.	Post viral cough	Diabetes, Hypertension.			1						1	Chills; Feeling hot; Headache; Hyperhidrosis; Injection site erythema; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1172AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1138N~1~SC~RA~PNEUMO (PNEUMOVAX)~1|TTOX~SANOFI PASTEUR~U10014AA~3~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0218147	03/24/2004	NJ	28.0	28		M	03/24/2004	Memory Loss, Facial Twitching around eye lid, Headaches,Extreme Fatigue,Unexplained Hair Loss,Numbness below waist, Decreased hearing in both ears, Carpal tunnel, Joint pain, muscle achiness,lightheadedness, irritability, depression, sleeping too much, disorientation,confusion, dizziness, loss of sex drive, unexplained weight gain, Low body tempature.  Some symptoms come and go and some are permanent.  Being treated for arthritis, muscle relaxers to sleep, xanax and lexapro for depression and anxiety. Nurse follow up on 05/10/04 states: narcolepsy.								Y	N	11/16/2000	11/18/2000	2	Positive for HLA-DR4 gene. All 3 doses were given, with dates of 11/16/2000, 12/26/2000, and 10/11/2001.	PVT	UNK	Insulin(Humalog+Lantus) for Type I diabetes.  Also, I am presently taking xanax(1.0mg.), Lexapro(20mg.), Celebrex(400 mg. 2x per day), Flexeril(10mg.) Nurse follow up on 05/10/04 states: add Doxycycline. Pt was not taking Xanax, Celebrex or	None	Type-I diabetes; chronic fatigue syndrome (ASTHENIA) and positive Epstein Barr (INFECT VIRAL), chronic sinusitis (SINUSITIS), shoulder pain (ARTHRALGIA), and myalgia (MYALGIA)	More systoms came at various times, but I was diagnosed with narcolepsy and other false diagnosis~Lyme (LYMErix)~2~28.20~In Pati		1						1	Alopecia; Amnesia; Arthralgia; Arthritis; Carpal tunnel syndrome; Confusional state; Depression; Disorientation; Dizziness; Fatigue; Headache; Hypoacusis; Hypoaesthesia; Irritability; Laboratory test abnormal; Libido decreased; Muscle twitching; Myalgia; Somnolence; Weight increased	FLUX~UNKNOWN MANUFACTURER~E64370HA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|LYME~SMITHKLINE BEECHAM~LY146A9~1~IM~RA~LYME (LYMERIX)~1	USA	Disabling	Influenza
0218177	03/25/2004	UT	19.0	19		M	03/25/2004	About a week after being vaccinated in 10/03, pt states he got very weak, then later nauseated with occasional vomiting.  He saw a doctor and was started on zoloft, which didn't sit well with him.  He saw a doctor in 1/04.				Y					N	10/01/2003				UNK	UNK						1						2	Asthenia; Nausea; Vomiting; Asthenia; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0218177	03/26/2004	UT	19.0	19		M	03/25/2004	About a week after being vaccinated in 10/03, pt states he got very weak, then later nauseated with occasional vomiting. He saw a doctor  was started on Zoloft, which didn't sit well with him. He saw a doctor in a different state in 1/04.									N	10/01/2003				UNK	UNK		NONE	NONE			1						1	Asthenia; Nausea; Vomiting; Asthenia; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0218178	03/26/2004	AL	42.0	7		F	10/23/2003	Pt. said for the last 2 nights, she has had severe pain & shivering & red, sore, hot arm. Pt went to doctor today with temp of 101 degrees F. Pt. was told by doctor she has cellulitis & was given antibiotic shot & augmentin 2000 mg/day for 14 days. Pt requested both shots (flu and pneu.) in same arm.				Y					Y	10/21/2003	10/22/2003	1	Blood count	PUB	UNK	Premarin, multivitamin, vitamin E, calcium.	NONE	NONE		AL0411	1						1	Cellulitis; Chills; Erythema; Feeling hot; Pain; Pyrexia	FLU3~EVANS VACCINES~765181~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0872M~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0218179	03/26/2004	TN	60.0	60		F		Feb-26-2004 sore throat, hoarseness, fever, chills, coughing, up a lots of flem, running nose, soreness in eyes and nose. Weakness,appetite change, nauseated. Last till March 1st. Left me weak tired, no appetite. Went into health center was not treated March 9 2004.									N	11/07/2003	02/26/2004	111	Blood test-normal 11-7-2003.	PUB	PUB	Salstate Lisnopril, Loratadine, Metopholol.	Nerves-sinus.	Blood Pressure, nerves, mental problem.			1						1	Anorexia; Asthenia; Chills; Cough; Dysphonia; Eye pain; Fatigue; Nausea; Pain; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0218265	03/27/2004	MO	29.0	28		M	03/27/2004	Patient received anthrax #4 on 11-25-03. The following day he noticed severe left arm pain. He spoke to the doctor who advised him that this pain was common. Ten days following his immunization he began to notice pain going down his left arm with tingling in his middle and index finger. Spoke to his MD again who advised him that it could be 2-3 months before his symptoms resolve.  Began to notice in mid Dec that his pain became constant with pain now noted along the left side of his upper back and shoulder area with occasional pain to left side of neck. He stated that the pain increased with movement. Denies any pain in his elbow. Patient reported that he took no form of pain relievers and that he was able to continue working, in spite of the pain. States his job, as a generator mechanic, does not involve bending, twisting, or lifting but reported problems when he would use a wrench. Pt is left-handed.  In January he noted that his left arm was getting weaker and at that time he scheduled a visit with a medical provider on Jan. 3, 2004. Provider assessed his sleeping habits and suggested placing a mattress on his cot and prescribed an anti-inflammatory. On Feb 4,2004, he returned to the clinic stating that he is no better and was still loosing strength in his arm. After physical therapy consult it was suggested he go for a MRI.   Left Feb. 12 and the provider was concerned about this being a problem with the disc in his neck, advised he return to the states for further work up.  Returned on February 20 and underwent MRI studies.   Currently pending neurosurgical evaluation.				Y					N	11/23/2003	11/24/2003	1	o Left Brachial plexus MRI 20 Feb o4: FINDINGS: Images through the left brachial plexus revealed a normal appearance of the brachial plexus structures. No masses or areas of   abnormal enhancement are demonstrated. The adjacent muscular and vascular   structures appear unremarkable.        IMPRESSION: Unremarkable brachial plexus evaluation.  o MRI  C-Spine wo/w contrast 20 Feb 04: FINDINGS: Vertebral body alignment, height and marrow signal are normal.  Disk space height is normal. The spinal cord appears normal in caliber and  signal throughout. Evaluation of the disk planes reveals a prominent left foraminal disk  herniation at C6-7, that appears to compress the C7 nerve root in the neural foramen, and slightly alters the contour of the thecal sac, and  appears to deviate     posteriorly the C8 nerve root in the anterolateral  aspect of the thecal sac.  The other disk planes    reveal no significant canal or foraminal stenosis.   IMPRESSION: Left C6-7 foraminal disk herniation.	MIL	MIL	DENIES	DENIES	DENIES			1						1	Back pain; Laboratory test abnormal; Muscular weakness; Neck pain; Pain; Paraesthesia; Shoulder pain	ANTH~EMERGENT BIOSOLUTIONS~~4~SC~LA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0218214	03/29/2004	MO	46.0	46		M	03/23/2004	Flu vaccine 11/5/03. Reported felt normal until 11/26/03; symptoms of tingling and numbness. 2 days later, dizziness, ataxia, was seeing PCP; back x-ray done. 12/1/03, complained of feeling like band around abdomen. 12/5 PCP. 12/11/04, Neuro-conduction study. 12/16/03 fell three times and seen in ER; MRI and CT of head. Hospitalized 12/16/03 through 12/22/03. Treatment 0.4g/kg IGIV for 5 days. Improved coordination and ataxia and weakness during stay. Sent to rehab; no better or worse. Hospitalized again 1/28/04 through 2/2/04 and 03/08/04 through 03/15/04. Currently in rehab at hospital. Discharge summary disproves med error. msv				Y	Y	18	Y		U	11/05/2003	11/26/2003	21	Extensive work-up lab x temp. EMG - nerve biopsy to R/O tumor = demyelinating neuropathy. Hx of GBS secondary to flu vaccine. Medical record states bone disorder, abnormal lab test. msv	OTH	UNK	Atenolol, Zocor, Zetia, ASA, Niacin, Prevacid, Naproxen, Nifidepine		HTN, Hypercholesterimia			1						1	Abdominal discomfort; Asthenia; Bone disorder; Coordination abnormal; Dizziness; Fall; Hypoaesthesia; Laboratory test abnormal; Paraesthesia	FLU3~EVANS VACCINES~765980~7+~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0218215	03/29/2004	NJ	80.0	80		F	03/17/2004	Paralyzed with GBS. On ventilator for two months. In hospital for six months. Residual numbness and balance problems. Uses walker Medical record states fever, apnea, ptosis, dysphagia, injury accident, pain.			Y	Y	Y	180	Y	Y	Y	01/01/2001	01/01/2001	0	Spinal to confirm GBS.	PVT	UNK		NONE	Sulfa Medical records state atrial fibrulation, hypertension, bone disorder, retinal disorder, anemia, cholelithiasis, colitis. msv			1						1	Accident; Apnoea; Balance disorder; Difficulty in walking; Dysphagia; Eyelid ptosis; Guillain-Barre syndrome; Hypoaesthesia; Injury; Pain; Paralysis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0218224	03/29/2004	NV	55.0	54		M	03/19/2004	Right upper arm swollen, red, firm and warm to touch. Ct c/o fever, aches 6hrs post administration. Continued to experience fever, aches to date. Have improved some since 3/17/2004 administration. Ct referred to MD at an outreach clinic.				Y					N	03/17/2004	03/17/2004	0		PUB	PUB		NONE	NONE			1						1	Erythema; Feeling hot; Injection site reaction; Oedema peripheral; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1093AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0947N~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0218269	03/29/2004	FL	69.0	69		M	03/29/2004	Felt weakness in legs initially; progessed to the point over 6 weeks of paralysis in legs and arms. Finally diagnosed with CIDP, a form of Guillan Barre Syndrome. Still recovering as of now. In outpatient physical therapy.  Still walking with a walker or in a wheelchair  Nurse follow up on 06/28/04 states: ADD: DVT, EMG abnormal.  Nurse follow up on 08/04/04 states: Chronic inflammatory demyelinating polyneuritis									N	11/15/2003	12/01/2003	16	mri, spinal tap, muscle biopsy, emg, lab tests abnormal	PVT	PVT		none	Hyperlipidemia, DM, Hypertension, Glaucoma, CA of prostate, Diabetis Mellitis,			1						1	Deep vein thrombosis; Difficulty in walking; Laboratory test abnormal; Muscular weakness; Neuropathy; Paralysis	FLU3~SANOFI PASTEUR~U1090AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0218275	03/29/2004	NC	35.0	35		M	03/29/2004	Ulnar neuropathy, Recurrent URI, Night Sweats, Arthralgia.  HPI:  Patient received smallpox vaccination (primary-3 jabs), Anthrax #1, Hep A #1, MMR, TD, Hep B #1, IPV, Typhoid, and Influenza vaccinations on 10/16/03.  He developed fever, chills, generalized muscle aches, and cold-like symptoms the next day.  He also reports night sweats for two weeks that have persisted.  Of note, he received Anthrax #1 in tricep area of left arm.  He does not recall any redness, knot, or pain at the site of the vaccination but he developed pain in his left elbow 2-3 days after the vaccine.  The pain was localized over the elbow but area without redness, swelling, or increased temperature.  On 11/4/03, he received Anthrax #2 in his right arm tricep area.  He recalls that he had a marble-sized knot that developed at the site of vaccination, along with some redness the same size as the knot.  He states that the knot persisted for 1-2 months.  He states that his arm was sore at the site of the vaccination but does not recall any lymphadenopathy or limitation in movement with his arm. Approximately one week after the vaccination, he developed numbness and tingling in bilateral hands while driving with both hands on the steering wheels.  The sensation started at the level of the wrists and radiated down to the tips of all fingers.  He also started experiencing the same sensation at night when he would raise his arms up with elbow flexed and hands under his pillow.  He noticed it occurred first in his left hand but later developed in his right hand as well.  The numbness and tingling would resolve in a few minutes if he changed the position of his arm and shook out his hands.  He did not seek medical evaluation at that time.He also began experiencing a burning ache in his right elbow a few days after this vaccination that was the same as the pain he had experienced in his left elbow.  He continues to experience the aching discomfort on a daily basis, most often while at rest or at night.  On 11/21/03, he received Anthrax #3 SQ in his right deltoid and Hep B #2.  He continued to experience the numbness and tingling in bilateral hands and wrists and the burning ache in bilateral elbows.    On 2/18/04, he was referred to the Healthcare Center for evaluation of above symptoms.  He continues to experience the peripheral neuropathy and arthralgia in bilateral elbows.  He took Ibuprofen almost daily in November 2003 but stopped taking it in December 2003 when the elbow arthralgia seemed to be getting better.  However, in January 2004 while on sitting on a bus for 3-4 hours, he started developing the same burning ache in bilateral knees.  Since then, he has experienced daily pain in bilateral knees and elbows.  He continues to notice the pain more with rest and at night.  He denies any difficulty with movement but states that at times after resting for long periods of time, he feels unsteady and weak.  He states, I have to force myself through the motion, but once I get going, I feel normal.  He notices this after sitting or lying for long periods and when he first starts lifting weights.He also is concerned over recurring upper respiratory infections.  He states that since November, he never feels totally well.  He reports frequent sneezing, rhinorrhea, and chest congestion.  He denies any past history of environmental or food allergies.  In addition, he developed an ear infection and conjunctivitis in November 2003 and again at the beginning of February 2004.  He reports occasional continued night sweats that occur for a few nights, then stop, only to return a few weeks later.  He is unsure of whether or not he has had any fever.  He sought medical evaluation for the conjunctivitis and respiratory symptoms in November 2003 and 11 Jan 04. He has used Tylenol PM, Sudafed, and Vicks OTC medication as needed.   Treatment:  Motrin 800 mg po TID, elbow splints qhs				Y					N	10/16/2003	10/17/2003	1	23 Feb 04 Chem 7:  WNL except BUN 24 H CBC:  HGB 12.6 L, HCT 37.4 L with normal indices MCV 84.2, MCH 28.3, MCHC 33.6, RDW 13.8 ANA:  <1:80 RF:  Negative C Reactive Protein:  0.9 ESR: 2 WNL  Raji Quantitative 16.0 H (normal is <=15.0, Equivocal 15.1-19.9, Positive >= 20.0), C1Q Binding Immune Complex 6.0 H (Normal is <4.0).  EMG: (3/24/04)  Sensory and Motor Nerve Conduction.  Conclusions:  There is an abnormal electrodiagnostic exam with bilateral ulnar neuropathies at the elbow.  There is no evidence of a general polyneuropathy as may be related to a post-vaccination demyelinating syndrome.	MIL	MIL	Medications: o Tylenol or Motrin as needed.   o Multivitamin daily	None	Past Medical History: o Acne- now well-controlled.  Previously on Accutane for 6 months in 1998.   o ? History of Psoriasis o Borderline Anemia.  During routine laboratory testing while on Accutane, it was noted that he was borderline anemic.  This was also later noted on a work physical in 2001.  He took iron supplements for a few months.  He has not had any work-up related to the anemia.  He denies any known source of blood loss-no hematuria, hematochezia, or melena. o Denies any history of arthritis, allergies, asthma, cancer, diabetes, hypertension, thyroid dysfunction, or immunosuppressive condition.  Surgical History: o  Left knee arthroscopic surgery 1993.  From the time of the surgery until Jan 2004, he had not had any further problems with this knee and states that in fact, he had run 2 marathons without problems with his knee or other joints. o Right elbow surgery 1998- as a result of trouble with in locking up all the time.  Previous dislocation in 1994.			1						1	Arthralgia; Chills; Erythema; Hypoaesthesia; Injection site mass; Joint range of motion decreased; Laboratory test abnormal; Myalgia; Nasal congestion; Neuropathy; Neuropathy peripheral; Night sweats; Pain; Paraesthesia; Pharyngitis; Pyrexia; Rhinitis; Rhinorrhoea; Sneezing; Upper respiratory tract infection	ANTH~EMERGENT BIOSOLUTIONS~~1~SC~LA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~1~IM~RA~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~1~IM~RA~HEP A (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~1~SC~RA~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~1~SC~RA~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4020074~1~ID~LA~SMALLPOX (DRYVAX)~1|TD~UNKNOWN MANUFACTURER~~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0218293	03/30/2004	MN	12.0	12		M	12/08/2003	Maybe 30 minutes after vaccine, patient complained of a itchy throat. Then itchy inside his chest. He then coughed and said his lungs felt tight. He had developed a rash beginning hives on his chest as well. He was given epinephrine and 50mg prednisone in ER. Medical records state anaphylaxis. msv				Y	Y	1			Y	12/02/2003	12/02/2003	0	NONE	PVT	PVT	Wellbutrin; Zithromax; Zyrtec; Singulair; Advair inhaler	Sinus infection	Allergies to mold, animal dander, grass, antibiotics	~DTaP (no brand name)~~0.00~In Sibling|~DTaP (no brand name)~~0.00~In Sibling		1						1	Anaphylactic reaction; Chest discomfort; Cough; Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U1170AA~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0218394	03/30/2004	OH	73.0	73		M	03/30/2004	Pt. called this RN on 03/24/04 and stated that he had redness, tenderness and swelling at injection site immediately after receiving his flu vaccine.  He states that he continued with these symptoms and has had intermittent fluid leaking from this site ever since.  Denies ever having any fever.  This RN instructed pt. to call his family doctor.  He was seen by his family doctor on 03/25/04 and this RN received a telephone call from the doctor's office.  She stated that pt. was seen for a red raised area of approximately 2x3cm on left deltoid.  Area was abcessed.  Area was drained and cultures were sent to the lab.  Pt. was given RX for Augmentin 875mg BID for ten days.									U	10/17/2003	10/17/2003	0	Culture of drainage sent to lab.	PUB	UNK		none known	unknown			1						1	Injection site abscess; Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1145AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0287N~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0218348	03/31/2004	MO	33.0	33		M	03/19/2004	Local rash/swelling with injection site assoc with flu-like symptoms-headache, body aches, upper respiratory signs (anthrax injection site only)- occurred with initial injection 1-16-03 & reoccurred 11-16-04 & twice thereafter- lasted 3-7 days each episode- spontaneous onset & resolution and gradually decreasing in severity.				Y					Y	11/06/2003	01/16/2004	71	UNK	MIL	MIL	NONE	NONE	Penicillin, Codeine, Milk,- No med conditions.			1						1	Headache; Influenza like illness; Injection site oedema; Injection site rash; Injection site reaction; Pain	ANTH~EMERGENT BIOSOLUTIONS~FAV077~7+~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U0956AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0218387	03/31/2004					U	03/24/2004	This case was considered medically important (OMIC). Information regarding Flumist nasal solution was received from an attorney regarding a patient who experienced Guillain Barre. The patient received vaccine on an unspecified date. Relevant medical history was not provided. Indication for Flumist was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. An attorney reported that a patient experienced GBS following receipt of Flumist. The attorney declined to provide any further information due to potential litigation; no lawsuit has been filed. The attorney stated that if improperly shipped and stored Flumist had been administered to a patient, then interstate commerce could be involved if a patient got sick. The attorney mentioned, there is a bill in Congress which lists influenza as covered for compensation, which is an attempt by your company to limit liability towards problems like this. No additional information was available at the time of this report.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQWYE014122MAR04	1						1	Guillain-Barre syndrome; Guillain-Barre syndrome	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0218400	03/31/2004	IN	54.0	54		F	03/24/2004	14 days after taking flu vaccine I got sore throat, lung congestion. Seen at ER on 11/9/03 w/ all symptoms of flu. Am still having breathing problems as of 3/4/04 w/ wheezing, SOB. I was in perfect health before taking vaccines. Given Prednisone, Albuterol inhaler, Cedal, Mavaquin, Keflex, Singulair. Respiratory tract infection, sore throat, cough, chest congestion-no strep throat hosp. does not have flu test but ER Dr states was flu. Information from Annual Follow-up report states I now have adult onset asthma following the flu/pneumonia I got a week after I got the vaccines. I just found out I have 3 blockages in my heart; this is probably due to being put on steroids for flu/pneumonia against my wishes and I have gained 20 pounds. My blood pressure is also elevated. Since I had the shots, my health has deteriorated! I was in perfect health before taking these vaccines. I have had loss of income, health, normal activites and energy. I intend to sue. These vaccines gave me the flu/pneumonia, and I have not been healthy or felt right since. I'll never take them again.				Y				Y	N	10/20/2003	11/03/2003	14	Respiratory tract infection, sore throat, cough, chest congestion. No strep throat. Hospital does not have flu test, but ER doctor states was flu.	PVT	OTH	Buspar; Ambien; Depakote; Vitamin C; Multivitamin	NONE	Asthma as a child-non active for years prior to flu.			1						1	Asthma; Atrioventricular block; Blood pressure increased; Condition aggravated; Cough; Dyspnoea; Influenza like illness; Nasal congestion; Pharyngolaryngeal pain; Pulmonary congestion; Respiratory tract infection; Upper respiratory tract infection; Weight increased; Dyspnoea; Fatigue; Lung disorder; Malaise; Nasal congestion; Otitis media; Pharyngolaryngeal pain; Rhinorrhoea; Wheezing	FLU3~EVANS VACCINES~795180~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0604N~UNK~~~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0604N~UNK~~~PNEUMO (PNEUMOVAX)~2	USA	Disabling	Influenza
0218425	04/01/2004	TX	15.0	15		F	03/18/2004	Developed palpable purpuric rash, arthritis, gastrointestinal bleeding, needed blood transfusion. Also developed blood clot in left arm needing anticoagulation. Work-up showed crescentic glomerulonephritis and C-ANCA positive vascultiis. Later had pulmonary hemorrhage. Information from Annual Follow-up report states this patient is still on anti-congulation therapy.  Nurse follow up on 08/31/04 states: loss of consciousness; Dehydration; venious thrombosis; pleural effusion.  Nurse follow up on 09/15/04 states: loss of consciousness, dehydration, venious thrombosis, pleural effusion.			Y	Y	Y				Y	10/23/2003			C3, C4-wnl. ANA negative, C-ANCA positive	PVT	OTH	Zithromax, Ribitussin, Benzalin	Bronchitis	Reactive airway disease			1						1	Arthritis; Dehydration; Gastrointestinal haemorrhage; Glomerulonephritis; Laboratory test abnormal; Loss of consciousness; Pleural effusion; Pruritus; Pulmonary haemorrhage; Syncope; Thrombophlebitis; Thrombosis; Vasculitis	FLU3~SANOFI PASTEUR~U1139AA~7+~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0218504	04/01/2004	TN	28.0	27		M	04/01/2004	Severe myalgia and joint pain. Elevated liver enzymes, decreased testosterone, increased prolactin, mild anemia, severe fatigue, nausea, depression, anxiety over a period of just over four months (Late Oct, 2003 - Early Mar, 2004).   Treatment included pain management (morphine sulphate), Pherergan for nausea, Testim 1% for hypogonaotrophism, Ativan then Klonipin for anxiety, Lexapro and Wellbutrin for depression/anxiety, methotrexate injections for joint inflammation, nortryptiline for pain management. Levitra for sexual dysfunction				Y					Y	10/20/2003	10/25/2003	5	Blood tests, rhumatology referral, EMG and nerve conduction tests, MRI of pituitary gland, neurology referral, endocrinology referral.	PVT	PVT	At time of vaccination - Paxil CR 37.5 mg q d. Ativan 0.5 mg prn up to 3 times daily.	None	General Anxiety Disorder			1						1	Anaemia; Anxiety; Arthralgia; Blood prolactin increased; Blood testosterone decreased; Depression; Fatigue; Hepatic enzyme abnormal; Myalgia; Nausea; Sexual dysfunction	FLUX~UNKNOWN MANUFACTURER~~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0218454	04/02/2004	LA	72.0	71		F		This subject is a 72 year old female who died in her home while enrolled in a study. The subject received two doses of the study vaccine. The last dose prior to the death was given on 10/6/03. The subject's daughter reported that her mom was found dead in her home on 3/17/04, 163 post immunization. Suspected cause of death is a heart attack. No autopsy performed. Subject was not brought to the hospital. The death was reported by the investigator as unrelated to the study vaccine. Nurse follow up on 05/17/04 states: COPD, Hypertensive cardiovascular disease (Lung dis, Cardiovasc dis). The death was reported by the investigator as unrelated to the stud vaccine. Additional information received 7 April 2004. Concomitmant therapies and relevant medical history. Cross reference with 2003-00300 (SAE #2003-0-1056)- Same patient.	Y	03/17/2004							N	10/06/2003	03/17/2004	163		UNK	UNK	RSV/ Placebo, Xaxax, oxygen, Nasonex, lasix.		First dose of RSV vaccine or placebo and influenza vaccine administered on 17 October 2002. History of COPD, hypertension, aortic valve sclerosis, hyperlipidemia. History-smoker (45 pack, history) stopped 2000.		200401314	1						1	Cardiovascular disorder; Lung disorder; Myocardial infarction	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0218464	04/02/2004	TX	70.0	70		F	03/30/2004	Woke night up terrible pain in left hand, palm and fingers. Next couple days, left arm ached like flu, went across shoulder and down right arm to hand-HA's not been normal to this date 3/30/04. Left fingers are numb and hurt like have been too cold. Right fingers not as bad as left-after 4 mo some better. Went to Dr 12/8/03. Ibuprofen for pain. Still not normal. Constant pain and numbness sometime better/ worse-has never gone away. Where shot given-still sore. Information from Annual Follow-up report states not completely - still numbness in fingers all time. But not as bad and not near the pain.								Y	N	11/11/2003	11/13/2003	2	NONE Medical records states hyperglycemia, abnormal lab tests. msv	PVT	PVT	Hyzaar 50 12.5; Glucotrol 5mg	NONE	Sulfa, Zestril, Norvasc-diabetic, high blood pressure			1						1	Headache; Hyperglycaemia; Hypoaesthesia; Influenza like illness; Injection site pain; Laboratory test abnormal; Pain	FLU3~EVANS VACCINES~765873~1~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0218565	04/03/2004	FL	56.0	56		M	04/03/2004	THIS YEAR I GOT THE FLU SHOT. NO PROBLEM. I EAT  EGGS EVERYDAY. NO PROBLEM. ON 3/31/04 I WENT TO DR. WITH 103.5 FEVER AND BRONCHITIS. I TOOK  ONE LISINOPRIL-HCTZ 12.5 MG FOR BLOOD PRESSURE, TWO BIAXIN 500 MG AND TWO ADVAIR DISKUS  250/50 AND GOT AN INHALATION TREATMENT FROM DR FOR BRONCHITIS. I ALSO GOT A PNEUMONIA SHOT. WENT BACK TO DR ON 4/2/04 FOR TREATMENT FOR SHOT REACTION. DR RECOMMENDED HEAT AND CALL BACK ON 4/5 FOR FOLLOWUP. SHE SAID SHE HAS NEVER SEEN A REACTION LIKE MINE. MY CURRENT SYMPTOMS ARE NO FEVER DUE TO 2 BIAXIN PER DAY, ARM SOLLEN, HOT, SORE, AND RED FROM SHOT SITE TO 8 INCHES BELOW COVERING 80 TO 90 PERCENT OF MY ARM SKIN. I AM CURRENTLY TAKING BENADRYL. YOU MAY CONTACT ME BY PHONE OR EMAIL FOR QUESTIONS OR TREATMENT. YOU HAVE MY PERMISSION TO FAX THIS FORM. THIS IS MY PERMISSION FOR DOCTOR TO RELEASE ALL OF MY MEDICAL RECORDS.  JUST TALKED TO DOCTOR AND SHE WILL ALSO SUMBIT A FORM SO YOU DON'T HAVE TO CALL ME WITH A TREATMENT.				Y					U	03/31/2004	03/31/2004	0		PVT	UNK	SEE 7	SEE 7	SEE 7			1						1	Bronchitis; Erythema; Feeling hot; Pain; Pyrexia; Erythema; Feeling hot; Oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~ID~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0256N~UNK~~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0218510	04/05/2004		83.0			M		A report was received from a health care professional on 11/19/03 concerning a male vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: A follow up report was received from a health care professional indicating that the vaccinee experienced a fever of 101.5 degrees F and productive cough one day after receiving Fluvirin on 11/16/03. An x-ray taken on an unspecified date revealed a left lower lob infiltrate. The vaccinee died on 11/26/03. Concomitant medication taken included levofloxacin. Follow up pending. Discharge summary for 04/30/04 states: respiratory failure, pneumonia, acute renal failure, Rhabdomyolysis, shock, sepsis.	Y								N	11/16/2003	11/17/2003	1	X-ray: left lower lobe infiltrate	UNK	UNK	Levaquin				PJP200301127	1						1	Apnoea; Cough; Pharyngolaryngeal pain; Pneumonia; Pyrexia; Renal failure acute; Rhinorrhoea; Shock	FLU3~EVANS VACCINES~765855~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0218518	04/05/2004	MD				U		Minor reaction to small pox vaccine- redness around area. Local erythema & induration.									Y	03/30/2004				MIL	MIL	NONE	NONE	No known drug allergies.			1						1	Injection site erythema; Injection site induration	ANTH~EMERGENT BIOSOLUTIONS~~UNK~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~HEP A + HEP B (TWINRIX)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1	USA		Influenza
0218519	04/05/2004	PA	4.0	4		M	03/16/2004	Wheezing. Prednisone for 3 days. Shortness of breath. Albuterol 3 times a day for 3 days.				Y					Y	12/08/2003	12/09/2003	1	NONE done at ER.	PUB	PUB	NONE	NONE	NONE		PA0403	1						1	Dyspnoea; Wheezing	FLU3~SANOFI PASTEUR~U1688AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0218520	04/05/2004	DC	14.0	14		F	12/04/2003	Pt reported to the Health Unit 45 min after injection with left arm pain, radiating to hand; hand tingling, skin very sensitive to touch. Mild swelling at site with no redness. Treatment: IM Depo-Medrol 40 mg also to left deltoid. Then Motrin three times a day as needed.				Y					Y	12/03/2003	12/03/2003	0		OTH	OTH	Mefloquine	NONE	Childhood asthma, sulfa & emycin allergies/ Once had anaphylactic reaction to an allergy shot; never to a vaccine.			1						1	Hyperaesthesia; Injection site oedema; Pain; Paraesthesia	FLU3~EVANS VACCINES~765754~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0218627	04/05/2004	IL	1.3	1	.3	F	04/05/2004	7 days after shots, had running nose and fever for 72 hours. After 72 hours fever went down but sore throat and cough started. 1 day after fever went down, broke out in Measels-like rash				Y					Y	10/21/2003	10/28/2003	7	Throat cultures to rule out Scarlet Fever. They came back negative	PVT	UNK		Had mild cold at time of shots				1						1	Cough; Pharyngolaryngeal pain; Pyrexia; Rash morbilliform; Rhinorrhoea	DTAP~SANOFI PASTEUR~UA725AA~4~ID~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1075AA~1~ID~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0666N~1~ID~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0547N~1~ID~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0218575	04/06/2004	AZ				M	04/03/2004	Asthma, GBS. Nurse follow up on 05/18/04: dehydration, leg cramps, weakness in lower extremities, tightness in neck, numbness in fingers, difficulty standing.					Y	3			U				CSF protein elevated; EMG abnormal; lab values abnormal;	OTH	OTH	NONE	NONE	NONE			1						1	Asthenia; Asthma; CSF test abnormal; Dehydration; Guillain-Barre syndrome; Laboratory test abnormal; Muscle spasms; Nuchal rigidity; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Hospitalisation	Influenza
0218589	04/06/2004	WI	83.0	83		F	04/01/2004	Redness in face. Swelling and redness in the peri-orbital areas. Redness around each fingernail. Red, scaly rash over the chest, upper back and lower back. Still recovering.									U	10/01/2003			ANA, Lupus package, ESR, CK, C3, C4 cryoglobulian quant, IGG, IGA, IGM, Neutrophylic cyto AB, Serine Protease	PVT	OTH	Atenolol, Zestrol, Prozac	CRF, depression, HTN, CAD	CRF, depression, HTN, CAD			1						1	Erythema; Exfoliative rash; Eye swelling; Rash erythematous	FLU3~SANOFI PASTEUR~U1136AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1026M~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0218590	04/06/2004	AR	55.0	54		F	03/30/2004	Approximately 3 months, post vaccination, noticed sinking in on arm.									U	10/13/2003	02/28/2004	138		PVT	PVT		NONE	NONE			1						1	Skin atrophy	FLU3~SANOFI PASTEUR~U1103AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0218629	04/06/2004	CA	5.0	5		M	04/02/2004	This case was considered medically important (OMIC). Follow up information pertaining to patient identification, adverse events, lab data and patient outcome was received. Information regarding Flumist nasal solution was received from a health care professional regarding a 5 year old male patient who experienced fever, headache, body ache and jerky movements of his extremities. At 5 years of age, the patient received the first dose on 1/7/04. Patient had not relevant medical history. Indication for Flumist was immunization. Product was administered on 1/7/04. Dose regimen was 1 dose (IN). Patient was not taking concomitant therapy. On 2/16/04, the patient experienced fever, headache, body ache and jerky movements of his extremities. On 2/17/04 he was taken to the ER where lab tests were performed. The patient's white blood cell count was 37.1 x10^3/mm^3. While awaiting blood culture results, the patient began treatment with Rocephin. A nasal swab performed at this time returned positive for influenza A&B. The patient was discharged on the same day. Repeat lab tests done on 2/25/04 showed a white cell count of 13.5 x10^3/mm^3 and neutrophil and lymphocyte percentage of 37.5% and 54.4% respectively. It was noted that the patient recovered.									Y	01/07/2004	02/16/2004	40	Culture urine negative; WBC count 37.1 x10^3/mm^3; Neutrophil percentage 78.5%; Lymphocyte count 4%; Blood creatinine results 0.5 mg/dL; PCO2 19 mmol/L; Blood culture negative; Viral test positive nasal swab for influenza A&B; Blood glucose 143 mg/dL; WBC 13.5 x10^3/mm^3; Platelet count 463 x10^3/mm^3; Neutrophil percentage 37.5%; and Lymphocyte count 54.4%.	PVT	PVT	NONE	NONE	UNK		HQWYE123918FEB04	1						1	Drug ineffective; Dyskinesia; Headache; Laboratory test abnormal; Pain; Pyrexia; White blood cell count increased; Drug ineffective; Headache; Pain; Pyrexia; Viral infection	FLUN3~MEDIMMUNE VACCINES, INC.~500005P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500005P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0218724	04/06/2004	NJ	75.0	75		M	04/06/2004	FLU VACINE GIVEN ON NOV.6, 2003. PATIENT HAD TWO MECHANICAL HEART VALVES.  WAS ON AN ANTIBIOTIC AT THE TIME THE VACCINE WAS GIVEN.  FOUR DAYS LATER WENT INTO CONGESTIVE HEART FAILURE. HOSPITALIZED FOR 4 DAYS.  CONTINUED TO GET WEAKER OVER THE LAST THREE MONTHS.  LEG PAINS, WEAKNESS. PATIENT PAST AWAY MARCH 16TH 2004.  SEEMED TO BE IN GOOD HEALTH UNTIL THE VACCINE.  CARDIOLOGIST FEELS ONE OF THE VALVES FAILED.  I BELIEVE THE FLU VACCINE IS WHAT THE  PROBLEM WAS. Per death certificate, cause of death was acute MI valvular disorder.	Y		Y	Y	Y			Y	N	11/03/2003	11/06/2003	3		PUB	UNK		BRONCHITIS	MECHANICAL HEART VALVES DUE TO RHUEMATIC FEVER AS A CHILD			1						1	Asthenia; Cardiac failure congestive; Myocardial infarction; Pain	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Results in Death	Influenza
0218749	04/07/2004	TX	1.0	1	.0	F	04/07/2004	Child developed vesicular rash at site of injection. rash spread rapidly in dermatomal distribution and consistent with shingles. Treated with oral acyclovir and improved.				Y					Y	10/24/2003	03/02/2004	130	Referred to ID specialist who confirmed diagnosis	PVT	PVT	No	No	No			1						1	Herpes zoster; Injection site rash	FLU3~SANOFI PASTEUR~UIIIIAA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0827N~4~IM~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0667N~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0568N~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0218734	04/08/2004	PA	47.0	46		M	03/25/2004	Pt reports by the time he was in his vehicle he was experiencing a funny feeling in his throat and sinuses, and had stuffiness & drainage from nose. Vaccine given on Friday AM, 12/12/03. By Sunday, client had continued upper respiratory symptoms and severe, sharp pain in knees and shoulder joints. Also complains of chills with symptoms bad enough to go to bed with. States this is unusual for him as he rarely gets these types of symptoms. By Tuesday, client was better and able to attend classes at school. Within another 10 days, the upper respiratory symptoms returned and persisted. Client was able to function and continue going to classes. About 3 weeks following the shot, the upper respiratory symptoms returned again. This time the client experienced severe paralysis in his arms. He describes severe pain in his elbows with burning on his skin 1/2 way down his forearm and numbness from there to his wrists. He states the left was slightly worse than the right. The symptoms gradually improved until the first week in March. Client states the week of March 1st, he experienced paralysis, burning, tingling, and numbness again to the point of being unable to write or use his computer. He states if he pinched his forearm, he was unable to feel it. He states his fingers could not move and he was unable to make a fist. He also describes neck stiffness and rigidity, lower back pain, and pain and stiffness in his calves. He describes having to use both arms to be able to pick up a textbook in class. On March 5th he saw his physician, who suggested among other things that it might be a reaction to the flu shot. He states he is still having tingling sensations in his hands. Denies any redness or swelling. Is to see a new physician on Monday 3/29/04 and has a return appt. with doctor on Friday 4/2/04.				Y					N	12/12/2003	12/12/2003	0	No testing yet.	PUB	PUB	Medications the client was on included: Dexadrin, Lamictal, Vitamins, Calcium, Gink, He states he has taken nothing in the past two weels. His physician tried him on Celebrex but he was unable to continue taking it due to side effects. He h	NONE	Client states he has experienced mild seasonal allergic asthma in the past.  States it is not chronic. Reports having allergies years ago and also going through desensitization injections to alleviate the symptoms. Client reports having lumbar and leg pain approximately 2 years ago and having MRIs for this. States nothing was determined as the cause. Client reports that a nephew developed Guillain-Barre syndrome several years ago. Client denies ever having the illness.			1						1	Arthralgia; Back pain; Chills; Hypoaesthesia; Musculoskeletal stiffness; Nasal congestion; Nuchal rigidity; Paraesthesia; Paralysis; Rhinorrhoea; Skin burning sensation	FLU3~EVANS VACCINES~765668~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0215904	04/09/2004	VA	42.0	42		F	01/13/2004	Flushing of skin, throat felt tight, difficulty breathing. Shot area-itching and lasted 10 minutes.									Y	01/09/2004	01/09/2004	0		MIL	MIL		NONE	Septra, ASA, Shellfish			1						2	Anaphylactic reaction; Dizziness; Dyspnoea; Flushing; Injection site rash; Syncope; Throat tightness; Urticaria; Dyspnoea; Flushing; Hypersensitivity; Pruritus; Throat tightness	FLUX~UNKNOWN MANUFACTURER~U129AA~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1269AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0218780	04/09/2004	VA	31.0	31		F	11/13/2003	Left arm red, hard, tender to touch. Itching, tingly, slight numbness intermittent through arm. 4x2 area of erythema.									U	11/12/2003				MIL	MIL		NONE				1						1	Erythema; Hypoaesthesia; Injection site induration; Paraesthesia; Pruritus; Tenderness	FLU3~EVANS VACCINES~765757~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0218850	04/12/2004	PA	69.0	69		F		This subject is a 69 year old female who was admitted to a progressive care unit due to seizure while enrolled in a Comparative Randomized Study of Safety and Immunogenicity of a Non-Adjuvanted Respiratory Syncytial Virus Vaccine versus an RSV vaccine adjuvanted with Aluminum Phosphate When Administered Concomitantly with a Licensed Influenza Vaccine in High-Risk Adults > or = 65 years of age. The subject received the second dose of RSV vaccine or Placebo and Influenza vaccine on 11/7/03. The first dose not reported. The subject experienced a seizure 80 days post immunization and was taken to the ER on 1/26/04. Subject had sonorous respirations and was unresponsive with persistent facial twitching. Treatment included Ativan, Dilantin, and oxygen. Subject was transferred to Progressive Care Unit/Telemetry. Clinical impression was epileptic seizure, cerebrovascular accident, postictal state, uncontrolled insulin dependent diabetes, hypertension. The seizure, cerebrovascular accident and uncontrolled insulin dependent diabetes were reported by the investigator as unrelated to the study vaccine. Additional information received 4/2/04. Subject was admitted to hospital on 1/26/04 for seizure and respiratory failure and was then transferred to a burn center for a skin problem associated with the epileptic medicine that she was receiving. Treatment for seizures included Dilantin. Subject expired at the burn center on 2/4/04, 9 days after admission and 89 days post immunization. Medical records not received by investigator as of yet. The respiratory failure and death were assessed by the investigator as unrelated to the study vaccine. Additional information received 4/6/04. Onset date of respiratory failure is 1/26/04. Additional information received 4/8/04: Date of death confirmed as 4/3/04. Exact cause of death and death certificate to follow.  Nurse follow up on 05/27/04 states: ADD: Anemia, Renal failure, GI bleed, Embolism, Pneumonia, CHF, Septic shock, Hemiplegia, GERD, Infect Bacterial (ANEMIA, KIDNEY FAIL, HEM GI, EMB, PNEUMONIA, HEART FAIL RIGHT, SEPSIS, PARALYSIS, GI DIS, INFECT BACT)  Follow up on 07/12/04 states: Main diagnosis is Seizures. Pt was admitted to the hospital on 01/26/04 after family witnessed Grand Mal Seizure. MD verbally noted respiratory failure upon admission also. Pt was discharged from hospital 02/19/04 to a nursing home and then to a burn center for skin problems associated with epileptic medication reaction. Pt expired at the burn center on 04/04/04.  Follow up on 08/06/04 states: Subject expired at the burn center on 04/02/04, 67 days after admission and 147 days post immunization.  Onset date for respiratory failure is 01/26/04. Date of death confirmed as 04/02/04. Exact cause of death and death certificate to follow. Main diagnosis is seizures. Pt was admitted to the hospital on 01/26/04 after family witnessed Grand Mal Seizure. MD verbally noted respiratory failure upon admission also. Pt was discharged from hospital 02/19/04 to a nursing home and then to a burn center for skin problems associated with epileptic medication reaction. Pt expired at the burn center on 04/02/04 (corrected). Discharge summary: Admission date 01/26/04, Discharged date 02/19/04. The 69 year old subject had a grand mal seizure lasting for 10 minutes and was brought to the ER and treated with Dilantin and Ativan. Subject had a constricted pupil, peripheral pulses decreased. CNS-drowsy, responded to tactile stimuli. Left sided weakness noted. Detailed exam could not be performed due to sedation by Ativan. Tests performed included an Ultrasound of Kidney-unremarkable, CT of the head without contrast-mild atrophy-VQ scan-probability of pulmonary embolism considered quite low, chest x ray, one view on 01/26/04 poor inspiration, patchy infiltrates versus alveolar edema in the upper lobes. Left lower extremity venous Doppler-DVT, left common femoral vein and proximal superficial femoral vein. CT of the brain-no acute abnormalities. Electrocardiogram showed no acute process. Echocardiogram had no obvious RWMAs at rest. Probable C LVH. Trivial degenerative changes, aortic and mitral valves. Technically difficult to perform study. Hospital course: admission orders in addition to routine PCU orders included neuro checks, seizure precautions, IV fluids, nothing by mouth, Foley catheter, O2 protocol, sliding scale Humulin R insulin coverage SC, IV Lopressor and additional Regular Insulin and also Zofran IV prn nausea. Consult from neurology with his impression of breakthrough seizure most likely secondary to metabolic abnormalities, elevated glucose, history of seizure disorder secondary to old CVA, residual left hemiparesis. A PICC line by interventional radiology which was carried out. The pt was confused/disoriented. Had no localized neurologic signs.  Th ept was cultured and put on IV Rocephin. She had increased temperature of 104.5. She was found to have a DVT, left leg.  An infections disease consult was obtained with impression of fever most likely secondary to aspiration pneumonia after seizure disorder. Recommended Ceftriaxone addition to Clindamycin. The pt was alert but nonverbal.  Did not follow commands.  Blood sugars were over 300. Dilantin level was 8.4, she was given extra dose of Cerenex. House physician was called to see the pt the am of 01/29 for hypertension with SBP in the 180s. She was also hyperglycemic at 380. She was given Lopressor. He felt she might benefit from a spinal tap. Recommended repeat of Ct of the head and follow up with neurology. En route from CT scanner her nurses reported the pt became apneic. Pulse oximetry dropped to 78. Code Blue was called when the pt returned to the room. Upon arrival of house physician she was stable. Pulse oximetry was 98%. She was transferred to ICU for closer monitoring with consideration for possible need for intubation for airway protection. A VQ scan showed low probablity for pulmonary embolism. ECG with QT prolongation which he felt probably related to metabolic disturbance specifically hypokalemia, associated drug effect an/or CNS effect. He recommended repleting K and magnesium, additional diagnostic studies, adjustment of blood pressure medication. CT scan showed no change from study of 01/26/04. No acute lesion. Temperature was 103.8, white count 10.1. Doctor felt we should presume meningitis. Ampicillin was added. Clindamycin was discontinued. LP was recommended. Urologic consult was obtained re hematuria on anticoagulation therapy for DVT. Recommended holding of heparin until urine cleared and then attempt to restart. If recurrent hematuria, then consideration to renal ultrasound. A nephrology consultation was obtained, his impression of seizure disorder, fever, fuled out aspiration pneumonia, diabetes poorly controlled, labile hypertension, on Cardene; mild hypoartremia. He recommended no free water and IV fluids, change of all IV medication to normal saline and if sodium dropped further, then consideration to discontinuation of Paxil. He also recommended daily BMP. The pt was more alert and smiling, verbalizing; temperature was 102.8.  Cardiology recommended a Greenfield filter. K was low and being repleted. IVC filter was place on 01/30/04 without complications. Hypoatremia was improving. K was being repleted. Creatinine was 1.5. Sugars were over 300. She again had hematuria on heparin. Urology recommended discontinuation of anticoagulation since Greenfield filter was placed. The pt's husband and daughter refused a lumbar puncture. They wanted to wait until the following week. The pt was much more awake and alert, oriented, followed commands with no further seizures. Dilantin level was therapeutic. Doctor felt there was no urgent need for lumbar puncture. Cardiology recommended start of PO fluids, assessing swallowing function, continuation of beta blocker and ACE inhibitor, resumptoin of low-dose anticoagulation and transfer out of ICU. The pt had no complaints. Was awake. Had no diarrhea. Urine was clear. Ultrasound of the kidney was a limited study; kidneys appeared normal. Outpt cystoscopy was recommended. Medication was adjusted. Creatinine was stable. She had no further hematuria. Cysto in office was recommended and discussed with pt husband.  She had no cardiac symptoms, Coumadin was resumed.  Wound care consult had been requested. She also had presumptive C.difficile colitis for which she had been treated with Metronidazole and Flucanazole for fungal dermatitis had also been administered, both of which were discontinued. Pt had no further breakthrough of seizures. Wound care was being carried out for bilateral buttock maceration, stage II ulcer at base of spine. Medications were adjusting for hypertension.  The pt was stable for discharge to the nursing home on 02/19/04.  Discharge Diagnosis: Breakthrough seizures, aspiration pneumonitis, suspected meningitis, suspected C.difficile colitis, fungal dermatitis, Subtherapeutic dilantin level, old cerebrovascular accident with left hemiparesis and known seizure disorder, decubitus ulcer, deep venous thrombosis, left lower extremity, greenfield filter placed, hypertension/hypertensive heart disease, diabetes mellitus type 2 non insulin dependant, obesity, coronary artery disease, status post myocardial infarction, sleep apnea, history of gstroesophageal reflux, chronic obstructive pulmonary disease, hypoatremia mild, hematuria on anticoagulation, QT prolongation secondary to metabolic disturbance specifically hypokalemia, allergy to E-Mycin and Tetracycline.  Complementary information form: SAE respiratory failure start date 01/26/04, stop date 02/19/04. The following events are all pre-existing and are not SAEs (part of history): cerebrovascular accident, uncontrolled insulin dependent diabetes, hypertension. Death certificate will be sent when available. 07/30/04: Upon internal review, correction to the date of death in the narrative was made to 04/02/04.  Cross reference with cases F20030006, 2004-00009.	Y	04/02/2004	Y		Y	9			N	11/07/2003	01/26/2004	80	Blood samples were obtained. Pulse oximetry: No 01/29/04 98% on 2 liters. On 02/19/03 97% on 2 liters.	UNK	UNK			Insulin dependent diabetes, hypertension		200400397	1						1	Anaemia; Bacterial infection; Cardiac failure; Cerebrovascular accident; Coma; Condition aggravated; Convulsion; Diabetes mellitus; Embolism; Gastrointestinal disorder; Gastrointestinal haemorrhage; Hypertension; Hyperventilation; Muscle twitching; Paralysis; Pneumonia; Renal failure; Respiratory failure; Sepsis; Skin disorder	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0218856	04/12/2004	PA	45.0	44		F	03/31/2004	Tingling, numbness in feet and hands. Weakness in arms and legs and walking unsteady. Had a greater difficulty with breathing. First 4 months the worst. Asked to have physical therapy; used inhaler. 11/5/02 ongoing. I had a TIA on 9/27/02 (it was my second one; the other had been in August of 1997). I had 4 different sessions of physical therapy (told therapist of the reaction to the flu shot and also an orthopedic doctor. Physical therapy March 2003 into January 2004. On 11/2/02, the doctor I was seeing knew of the 9/27 TIA because I told him of it then. But I was fine in October of 2002 except for my knee buckling more often, but I was able to walk everywhere. Walking is my main mode to transportation. I had to ask my family and friends to take me to town a lot after getting that shot. Most times, the first 4 months, I was down in bed unable to walk to the bathroom from the bedroom without holding on to the walls, doorways and the stove etc. Preparing meals was very hard to do, my hands didn't have the strength. I wish I had known about this report form back in November 2002 and that a patient or family member could fill this report out. Also, I didn't know a person could report an adverse reaction to the health department. On 9/24/03, I saw a doctor and was diagnosed with back pain and leg weakness and these remain, but not as bad as when it first started. It took 14 months to recover. I should have been properly diagnoses and treated in November of 2002. Doctors do not want to report. And doctors also want to point to the fibromyalgia when its not even the case of another medical condition. 11/4/02 Influenza vaccine in upper left shoulder (near bone). On 11/5/02, I woke up with severe pain in my upper arm (left) shoulder and neck and into the back of my head. I couldn't turn my head to the left and I had extreme fatigue and I couldn't get out of bed until about noon. That morning, while still in bed, I had numbness and tingling in both hands and feet, and then into my arms and legs. I was unsteady on my feet; felt like I'd collapse to the floor, but I didn't. My symptoms got worse when I was out in the cold and breathing became more difficult. I believe I called the doctor's office on the 6th and they set up an appointment for the 20th. He sent me for some blood work. It was more than 3 months later that he'd even began to take my medical condition seriously if at all. I believe he did so only because of the county assistance office and social security sending him forms to fill out. Because of his lack of properly diagnosing my condition and treating me, I discharged him as my doctor by September 2004. I did have MRI's and EEGs though, and still don't know what was wrong. With fibromyalgia to contend with and ongoing episodes of syncope of which I now believe may be episodes of narcolepsy, this has been since 1997 for syncope. I had a head injury and had gotten an electrical shock during that summer and have been passing out ever since. So if the fibromyalgia, TIA and/or narcolepsy has contributed to me getting an adverse reaction to the flu shot I do not know. I did not get the flu shot this past winter and I will not ever again. And the thing is, I had gotten a flu shot every year prior to November 2002 for 14 years, without any medical problems occurring. I also have seasonal allergies, endometriosis, and also anxiety. Had reactions to Vibramycin, Duricef, Cipro, Doxycycline. Also orthopedic doctor said I have bursitis in my left hip and my primary doctor has said I have osteoarthritis in my knees. Diagnosed after November 2002 in 2003.			Y	Y					Y	11/04/2002	11/05/2002	1	Cerv spine MRI abnormal, Positive vaso vagal test	PVT	UNK	Albuterol; Flexeril; Cholestyramine		Asthma; fibromyalgia; Darvocet (can't take); TIA; gastric ulcer; Migraine			1						1	Anxiety; Arthritis; Asthenia; Back pain; Balance disorder; Bursitis; Congenital musculoskeletal anomaly; Dyspnoea; Endometrial disorder; Fatigue; Fibromyalgia; Gait disturbance; Hypersensitivity; Hypoaesthesia; Narcolepsy; Neck pain; Paraesthesia; Shoulder pain; Syncope	FLU3~SANOFI PASTEUR~U09050AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0218863	04/12/2004	IL	1.17	1	.2	M	04/07/2004	Red swollen painful arm at site of injection.									Y	03/26/2004	03/26/2004	0	NONE	PVT	PUB	NONE	Abdominal pain.	NONE			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~PFIZER\WYETH~496760~4~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0218909	04/12/2004	OH	34.0	34		F	04/12/2004	Burning in chest left and right side mainly right.Burning in right side of stomach.  Burning begining on right side of stomach, up through chest down both arms and legs.  Tingling in elbows and knees.  Diarrhea with excessive weight loss.  Pail, restless nights, symptoms so severe would wake me up.  No treatment is getting better monthly, but not fully recovered to date.				Y					N	10/23/2003	11/07/2003	15	ultra sound gallbladder and chest, blood draws twice, echocardiogram, ekg, stress test, lower gi, endoscopy, colonoscopy, acid refluc test,neurologist	PUB	UNK	Urecholine Multivitamin	None	Benadryl Enviromental			1						1	Abdominal pain; Diarrhoea; Pain; Paraesthesia; Restlessness; Skin burning sensation; Weight decreased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0218565	04/13/2004	FL	56.0	56		M	04/05/2004	Extensively swollen arm 1/2 size lower aspect upper arm erythema hot- treated 4/3/2004 wi Medrol dose pak 4 mg & Benadryl.				Y					Y	03/31/2004	03/31/2004	0	UNK	PVT	PVT	Biaxin, Advair, Lisinopril, Pravahol.	Bronchitis	Increase blood pressure, increase lipid.			1						2	Bronchitis; Erythema; Feeling hot; Pain; Pyrexia; Erythema; Feeling hot; Oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~ID~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0256N~UNK~~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0218919	04/13/2004		76.0			M	02/26/2004	Vaccine administered. PCP reported that patient was given an influenza vaccine on 2/3/04 in geriatric clinic. Following day, he reported feeling ill, vomiting, weakness, fell; was admitted to hospital for 2 days for severe myalgia. Nurse follow up on 06/28/04 states: ADD: Headache, hypokalemia, anxiety, decreased appetite, rash.					Y	2			U	02/03/2004	02/04/2004	1	EKG WNL	UNK	UNK			Hard of hearing;			1						1	Anxiety; Asthenia; Decreased appetite; Fall; Headache; Hypokalaemia; Malaise; Myalgia; Rash; Vomiting; Asthenia; Fall; Muscular weakness; Vomiting	FLUX~UNKNOWN MANUFACTURER~U1146BA~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0218921	04/13/2004	DC	16.0	16		F	04/08/2004	Rash white bumps over face for 2 days then resolved. Weakness, tingling, pain in right arm for past three weeks.									N	03/16/2004	03/17/2004	1	UNK	PVT	UNK	Singulair, Albuterol, Benzaclingel	Sore throat, acne	Asthma			1						1	Asthenia; Pain; Paraesthesia; Rash	FLU3~SANOFI PASTEUR~U1132AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0219050	04/13/2004	GA	44.0	44		F	04/13/2004	Ache;joints and muscles, allergies, mood:anxiety, depression,heart arrhythmia,arthritis, bloating, heart ekg: abnormal, hair falling out, heart palpitation, insomnia, menstrual abnormalities, nasal heavy drainage, numbness and tingling of fingers and arm,lower back pain, right shoulder pain, pain at injection site, injection site swollen to the size of golf ball for at least on month, joint and muscle pain, soft tissue pain, eye pain, neck pain, skin rash, unable to sleep flat, night sweats, tens needed to control pain, sinusitis, change in pre-existing thyroid condition blurred vision, weight gain, visual field defected.				Y					U	02/25/2004	02/27/2004	2		MIL	MIL	ATENOLOL 50MG CELEXA 20MG ZYRTEC 10MG	RAPID HEART RATE , CHRONIC BACK PAIN	RAPID HEART RATE, CHRONIC BACK PAIN			1						1	Abdominal distension; Alopecia; Anxiety; Arrhythmia; Arthralgia; Arthritis; Back pain; Depression; Hypersensitivity; Hypoaesthesia; Injection site swelling; Insomnia; Menstruation irregular; Myalgia; Palpitations; Paraesthesia; Rhinorrhoea; Shoulder pain	ANTH~EMERGENT BIOSOLUTIONS~FAV081~4~IM~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U01129AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0714N~1~IM~RA~HEP A (VAQTA)~1|MMR~MERCK & CO. INC.~0351M~1~IM~RA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|SMALL~PFIZER\WYETH~~1~IM~LL~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0219044	04/14/2004	MD	4.0	4		M	01/13/2004	Injection site erythema. From initial information received on 08/Jan/2004 from health care professional regarding an adverse event occurring in the USA, it was reported that a four year old male patient received a fifth dose of DAPTACEL, lot number C1624AA, administered in the right deltoid, a second dose of FLUZONE, administered intra-muscularly in the left thigh and a second dose of MMR, manufacturer Merck, lot number 0271A1, administered subcutaneously in the left arm at 4:00 PM on 06/Jan/2004. Two days later, on the morning of 08/Jan/2004, the patient developed an erythematous area surrounding the injection site, which was described as resembling cellulitis. The patient was seen by a physician. The patient's recovery status was not reported. The reporter of this case is the same reporter of case number 2004-00089.				Y					U	01/06/2004	01/08/2004	2		PVT	PVT					200400090	1						1	Cellulitis; Injection site erythema	DTAP~SANOFI PASTEUR~C1624AA~5~~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1128AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~XO372~4~~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0271A~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0219109	04/16/2004	TX				F	04/12/2004	Developed influenza 9/26/03. Also had flu at 11/26-28/03 despite vaccine given 9/18/03.									Y	09/18/2003	09/26/2003	8		PVT	UNK		NONE				1						1	Drug ineffective; Influenza	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0219139	04/16/2004	TX	31.0	24		M	04/16/2004	PT HAD ARM INFLAMMATORY CELLULITIS WITH PAIN AT THE INJECTION SITE									Y	01/27/2004	01/28/2004	1		PUB	PVT	DEMEROL, PHENERGAN, MORPHINE	PANCREATITIS	PANCREATITS			1						1	Cellulitis; Injection site inflammation; Injection site pain	FLU3~EVANS VACCINES~765980~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~SANOFI PASTEUR~765499~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~SC~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0214972	04/19/2004	PA	9.0			M	02/24/2004	Pyrexia/ Fever, Rigors/chills, Rhinorrhea/Runny Nose, Cough, Pain. This report was received from the Center for Biologics Evaluation and Research (VAERS ID number 214972). Information regarding flumist 2003-4 formula influenza virus vaccine, live intranasal 2003-4 formula nasal solution frozen was received from a healthcare professional via a regulatory authority regarding a 9 year old male patient who experienced chills, body aches, high fever, runny nose and cough. At 9 years of age, the patient received the first dose f 22-Dec-2003. On 25-Dec-2003, the child developed chills/rigors, body aches/pain, high fever/pyrexia, runny nose/rhinorrhoea and cough. He was treated with Triaminic for flu, cold and cough. No additional information was available at the time of this report.									U	12/22/2003	12/25/2003	3	NONE	OTH	OTH	NONE	NONE	UNK		HQWYE247623FEB04	1						2	Chills; Cough; Pain; Pyrexia; Rhinorrhoea; Chills; Cough; Pain; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500004P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500004P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0216186	04/19/2004	AL	10.0			M	02/24/2004	Rash. This report was received from the Center for Biologics Evaluation and Research (VAERS ID number 216186). Information regarding Flumist 2003-4 formula influenza virus vaccine, live intranasal 20003-4 formula nasal solution frozen was received from a healthcare professional via a regulatory authority regarding a ten year old male patient who experienced a rash. At ten years of age, the patient received the first dose on 27/jan/2004. On 01/27/04, the child developed a rash near his nose after the vaccine was administered. The next day, the rash was on the side of his face. The reporter indicated that the child was in no distress. No additional information was available at the time of this report.									U	01/27/2004	01/27/2004	0	NONE	OTH	OTH	NONE	NONE	UNK		HQWYE248223FEB04	1						2	Rash; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500101P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500101P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0218629	04/19/2004	CA	5.0	5		M	03/02/2004	PYREXIA/FEVER. HEADACHE. PAIN/ACHE. Information regarding Flumist 2003-2004 influenza virus vaccine, live intranasal 2003-2004 formula nasal solution (frozen) was received from a healthcare professional regarding a 5 year old male patient who experienced fever 103  deg F, headache and body ache. At 5 years of age, the patient received the first dose on 07-Jan-2004. On 16-Feb-2004, the patient experienced fever 103 deg F, pyrexia, headache and body ache/pain; he had received his first dose of Flumist on 07-jan-2004. The patient was taken to the emergency room. A urine analysis and unspecified blood work were performed. Rocephin was administered and the patient was discharged. On 17-Feb-2004 the patient's temperature was registering subnormal and he was awake and alert. No additional information was available at the time of this report. Follow up: On 17FEB2004, he was taken to the emergency room where laboratory tests were performed. The patient's white blood cell count was 37.1x10^3/mm^3. While awaiting blood culture results, the patient began treatment with Rocephin (ceftriaxone). A nasal swab performed at this time returned positive for influenza A&B. The patient was discharged on the same day. Repeat laboratory tests done on 25FEB2004 showed a white cell count of 13.5x10^3 and neutrophil and lymphcyte percentages of 37.5% and 54.4% respectively. It was noted that the patient recovered.				Y					Y	01/07/2004	02/16/2004	40	blood test, urine analysis = normal range; On 17FEB2004 test results were: culture urine: negative, white blood cell count (37.1x10^3/mm^3); neutrophil percentage (results: 78.5%); lymphocyte count (results 4%); blood creatinine (results 0.5mg/dL); PCo2 (results: 19 mmol/L); blood culture (results: negative; virla test (results: positive nasal swab for influenza A&B); and blood glucose (results: 143mg/dl). On 25 FEB2004 test results were: white blood cell count (results: 13.5x 1/^3/mm^3); platelet count (results: 4663x10^3); neutrophil percentage (results: 37.5%); and lymphocyte count (results 54.4%)	PVT	OTH	NONE	UNK	UNK		HQWYE123918FEB04	1						2	Drug ineffective; Dyskinesia; Headache; Laboratory test abnormal; Pain; Pyrexia; White blood cell count increased; Drug ineffective; Headache; Pain; Pyrexia; Viral infection	FLUN3~MEDIMMUNE VACCINES, INC.~500005P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500005P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Emergency room visit	Influenza
0219179	04/19/2004	MO	0.58	0	.6	M	04/01/2004	This case was reported by a nurse practitioner and described the occurrence of possible muscular atophy or fat necrosis in a 7-month-old male patient who received diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix). On 24 November 2003, the patient received the second dose of Pediarix in his right thigh (lot 21893D9). On the same day, the patient received Haemophilus influenze type b conjugate vaccine (manufacturer unknown) and Influenza virus vaccine (manufacturer unknown). The site for the administration of Haemophilus influenzae type b conjugate vaccine and Influenza virus vaccine was not specified. On the same day, the patient experienced redness, and swelling at the injection site. On 26 November 2003, approximately two days after administration of Pediatrix, the swelling and redness at the injection site resolved and the patient developed what appeared to be and indentation at the injection site and possible muscle atrophy or fat necrosis. Approximately two months later,  the patient was examined at the physician's office. The nurse practitioner considered the events to possibly be related to vaccination with Pediarix.				Y					U	11/24/2003	11/24/2003	0	UNK	PVT	PUB		UNK	The patient's medical history, concurrent conditions, and concurrent medications were not reported.		A0495825A	1						1	Injection site erythema; Injection site necrosis; Injection site oedema; Injection site reaction; Muscle atrophy; Necrosis	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~21893D9~2~~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~UNK~~~HIB (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0219181	04/19/2004	IN				F	03/17/2004	SKIN LACERATION; ACCIDENTAL EXPOSURE. Information regarding Flumist 2003-2004 Formula (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a nurse who was administering the vaccine and experienced the syringe breaking  lacerating her thumb. A nurse, who was administering the vaccine, experienced the syringe breaking and lacerating her thumb (skin laceration) (accidental exposure). The reporter indicated that she is fine now. No additional information was available at the time of this report.									Y				UNK	OTH	OTH	UNK	UNK	UNK		HQWYE031917FEB04	1						1	Accident; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219182	04/19/2004	MD	2.0			M	01/19/2004	PYREXIA. Medication error. Rhinorrhoea, Runny Nose. Sneezing. Information regarding Flumist 2003-2004 Formula (influenza virus vaccine, live intranasal 2003-2004 formula nasal solution frozen was received from a mother regarding her 24 month old son who accidentally received Flumist, and experience a runny nose, sneezing, a fever of 102 degrees F and looks like a sick kid. At 24 months of age, the patient received a dose in early December 2003. Approximately 5 days post-immunization, the child developed a runny nose and sneezing. On 30-Dec-2003, he developed a fever of 102 degrees F and was treated with Children's Motrin (Ibuprofen). On 31-Dec-2003, he developed a fever of 102 degrees F and was treated with Children's Motrin (ibuprofen). On 31-Dec-2003, the fever resolved, but the mother stated he looked like a sic kid. As of 5-Jan-2004, the runny nose persisted. No additional information was available at the time of this report.									U				UNK	PVT	PVT	NONE	NONE	UNK		HQWYE062306JAN04	1						1	Medication error; Pyrexia; Rhinorrhoea; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219183	04/19/2004	CA				M	02/24/2004	Bronchitis. Sinusitis. Information regarding Flumist 2003-2004 formula influenza virus vaccine live intranasal 2003-2004 formula nasal solution frozen was received from a consumer regarding a male patient who experienced sinusitis and bronchitis. The patient received the first dose on an unspecified date. See related case HQWYE879510FEB04 (adverse event, non-expedited). No additional information was available at the time of this report.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQWYE074218FEB04	1						1	Bronchitis; Sinusitis	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219185	04/19/2004	VA	31.0			F	01/19/2004	RHINORRHOEA/RUNNYNOSE; FATIGUE/TIREDNESS; FEELING HOT/FEELING OF WARMTH; FEELING COLD/CHILLINESS; FEELING ABNORMAL. Information regarding flumist 2003-2004 formula influenza virus vaccine, live intranasal solution frozen was received from a 31 year old female consumer who developed a runny nose. She also felt funny and uncomfortable as well as warm, chilly and tired, after exposure to a sick person. The patient received a dose on 19-Dec-2003. On 19-Dec-2003, the day of vaccination, the patient developed a runny nose which lasted until the last few days. Then on 03-Jan-2004, she began to feel a little funny, tired, warm, chilly and uncomfortable,  after being exposed to someone sick on 01-Jan-2004. No additional information was available at the time of this report.									U	12/19/2003	12/19/2003	0	UNK	PVT	PVT	NONE	UNK	UNK		HQWYE170207JAN04	1						1	Fatigue; Feeling abnormal; Feeling cold; Feeling hot; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219186	04/19/2004	MA				M	02/09/2004	EPISTAXIS/NOSEBLEED. A nurse reported that a male child received a dose of flumist influenza virus vaccine, live intranasal 2003-2004 formula nasal solution frozen on 07-jan-2004 and experienced a nosebleed. The reporter described the nosebleed as just a few drops of blood. The night before Flumist vaccination, the patient experienced a nosebleed in the same nostril; the reporter indicated that the Flumist probably loosened a clot from the previous night's nosebleed. It is unknown if Flumist was administered into the second nostril. No additional information was available at the time of this report.									U				UNK	PVT	PVT	UNK	UNK	UNK		HQWYE199208JAN04	1						1	Epistaxis	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219187	04/19/2004	WI	11.0	11		M	03/17/2004	Follow-up information received from the physician revealed results of an orthopaedic consultation on 12/15/03, including lab and diagnostic test results.  Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal solution (frozen) was received from a nurse regarding an 11 year old male pt who experienced a fever of 104 deg F., left ankle pain, elevation of ESR (erythrocyte sedimentation rate), and elevation of CRP (C-Reactive Protein).  The pt received a dose on 12/12/03.  The pt was reported as healthy.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/12/03.  Dose regimen was 0.5mL (IN).  Concomitant medications were not reported.  On 12/14/03, 2 days post-immunization, the pt developed a fever of 104 deg. F. (pyrexia), and anteromedial lower left leg pain proximal to the ankle joint (arthralgia).  His fever was controlled with ibuprofen.  On 12/15/03, he was seen by an orthopaedic surgeon.  Abnormal lab values included an erythrocyte sedimentation rate of 21mm, and a C-reactive protein of 5 mg/dL.  Nuclear magnetic resonance imaging (MRI) of the left lower leg was normal.  On 12/18/03, the erythrocyte sedimentation rate was 35mm and on 12/19/03, the C-reactive protein was 6.18 mg/dL.  On 12/30/03, values of all labs drawn were within NL limits.  He was treated symptomatically.  Continued observation and activity as tolerated was recommended.  As of 01/07/04, the child's symptoms had resolved completely.				Y					Y	12/12/2003	12/14/2003	2	Antinuclear antibody (12/30/03): Negative; C-reactive protein (12/16/03, 12/19/03, 12/30/03): 5.0 mg/dL, 6.18 mg/dL, 0.52 mg/dL; Nuclear MRI (12/15/03): MRI of the left lower leg was normal; Red Blood Cell sedimentation rate (12/16/03, 12/18/03, 12/30/03): 21mm, 35mm, 11mm; White blood cell count (12/19/03, 12/30/03): 5.2 K/uL, 9.5 K/uL;	OTH	OTH	UNK	UNK	UNK		HQWYE199608JAN04	1						1	Arthralgia; Laboratory test abnormal; Pyrexia; Red blood cell sedimentation rate increased	FLUN3~MEDIMMUNE VACCINES, INC.~500010P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0219188	04/19/2004	NJ	6.0			F	03/16/2004	A nurse reported that a 6 year old female pt received a dose of Flumist (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on an unspecified date and developed the flu.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on an unspecified date.  Dose regimen was 1 dose.  Concomitant medications were not reported.  One day post-immunization, a female pt became sick with the flu (influenza).  The pt was not tested for positive flu type.  The reporter indicated that the pt's sibling was diagnosed via nasal swab for Type A/B flu, exposing the pt to the flu days prior to vaccination.  The reporter stated that a health care professional determined the pt's flu was related to exposure to her sibling prior to Flumist administration.  No additional information was available at the time of this report.									U					OTH	OTH	UNK	UNK	UNK		HQWYE243923FEB04	1						1	Drug ineffective; Influenza	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219189	04/19/2004	IL	6.0			F	03/17/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a mother regarding her 6 year old daughter who developed fever, headache, runny nose, sore throat, cough, muscle aches, fatigue and a sinus infection.  The pt received the first dose in Oct 2003.  The child had no relevant medical history.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered in October 2003.  Dose regimen was 0.5mL (IN).  Concomitant therapy included a 2nd dose of Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) on 12/03/03.  On 11/01/2003, seven to ten days after receiving her first dose of Flumist, the pt developed a fever (pyrexia), tiredness (fatigue) and a cough (cough).  She also had a headache, runny nose, muscle aches (myalgia) and sore throat (pharyngolaryngeal pain).  The headache occurred on and off approximately 3-4 times a week. She was diagnosed with a sinus infection (sinusitis) after being seen by the physician on 8 separate occasions.  She was treated with four different regimens of antibiotics.  After receiving her second dose of Flumist on 12/03/03, the symptoms continued.  As of 02/24/04, the headache, runny nose, muscle aches and tiredness remain. The sore throat and cough resolved approximately three weeks prior to 02/24/04.  No additional information was available at the time of this report.				Y					U		11/01/2003			PVT	OTH	UNK	UNK	UNK		HQWYE318025FEB04	1						1	Cough; Fatigue; Headache; Myalgia; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea; Sinusitis	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0219190	04/19/2004	FL	6.0			M	03/16/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a parent regarding his 6 year old son who received a dose of vaccine and experienced flu-like symptoms. Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on an unspecified date.  Dose regimen was not provided.  Concomitant medications were not reported.  The pt experienced flu-like symptoms (influenza like illness) immediately following receipt of vaccine (date unspecified).  His flu-like symptoms lasted about one week.  No additional information was available at the time of this report.									Y					OTH	OTH	UNK	UNK	UNK		HQWYE634608MAR04	1						1	Drug ineffective; Influenza like illness	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219191	04/19/2004	NY	11.0	11		F	12/19/2003	Information regarding Flumist (2002-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from the mother of an 11 year old female who experienced runny nose, congestion, cough and sore throat.  At 11 years of age, the pt received a dose on 12/12/03.  The child had no relevant medical history.  Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 12/12/03.  Dose regimen was 0.5mL (IN).  Pt was not taking concomitant therapy.  The mother reported that the child only received half of a Flumist dose in one nostril.  On 12/13/03, the child experienced runny nose (rhinorrhoea), congestion (nasal congestion), cough (cough) and sore throat (pharyngolaryngeal pain).  As of 12/17/03, her symptoms persisted.  No additional information was available at the time of this report.									N	12/12/2003	12/13/2003	1		OTH	PVT	NONE	NONE	UNK		HQWYE757919DEC03	1						1	Cough; Nasal congestion; Pharyngolaryngeal pain; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219192	04/19/2004	SC	13.0			M	01/02/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a 13 year old male pt who experienced a sore throat and cough.  At 13 years of age, the pt received a dose on 12/15/03. Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/15/03.  Dose regimen was 0.5mL (IN).  Pt was not taking any concomitant therapy.  On 12/16/103, 1 day post-immunization, the pt experienced a sore throat and cough.  He was being treated with Tanafed.  As of 12/17/03, the symptoms persisted.  No additional information was available at the time of this report.									N	12/15/2003	12/16/2003	1		PVT	OTH	NONE	UNK	UNK		HQWYE775319DEC03	1						1	Cough; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~500003P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219193	04/19/2004					M	01/02/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a male pt who experienced fever and sore throat.  The pt received a dose on an unspecified date. Relevant medical history was not provided. Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on an unspecified date.  Dose regimen was 1 dose 1 time per day (IN).  Concomitant medications were not reported.  The pt experienced fever (pyrexia) and sore throat (pharyngolaryngeal pain).  No additional information was available at the time of this report.									U					OTH	OTH	UNK	UNK	UNK		HQWYE785819DEC03	1						1	Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219194	04/19/2004	MD				F	01/02/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a female pt who experienced fever of 103 deg. F.  The pt received a dose on an unspecified date.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on an unspecified date.  Dose regimen was 1 dose (IN).  Concomitant medications were not reported.  The pt experienced fever of 103 deg. F (pyrexia).  No additional information was available at the time of this report.									U					OTH	OTH	UNK	UNK	UNK		HQWYE792019DEC03	1						1	Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219195	04/19/2004	OH	6.0	6		M	03/16/2004	Follow-up information pertaining to therapy and event start dates and recovery status was received from the reporter.  Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was reported by a healthcare professional concerning a 6 year old male pt who experienced 13 hours of vomiting after receiving the vaccine on 12/12/03.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/12/03.  Dose regimen was 0.5mL (IN).  Pt was not taking concomitant medications.  The pt experienced 13 hours of vomiting (vomiting) after receiving the first dose of Flumist on 12/12/03.  The pt recovered.  It was reported that the pt received injectable flu vaccine on 02/06/04.									Y	12/12/2003				PVT	OTH	UNK	UNK	UNK		HQWYE837505FEB04	1						1	Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500013P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219196	04/19/2004	CA	7.0	7		M	02/24/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a mother regarding her 7 year old son who got the flu.  The pt received the first dose on 12/11/03. It was reported that the child had no medical history.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/11/03.  Dose regimen was 0.5mL (IN).  Pt was not taking concomitant therapy.  The mother reported that on 12/14/03, three days post-immunization, her son got the flu, experiencing a fever of 103 deg. F, nasal congestion, and body aches.  The symptoms persisted until 12/16/03, resolving without treatment.  No additional information was available at the time of this report.									Y	12/11/2003	12/14/2003	3		PVT	PVT	NONE	UNK	UNK		HQWYE850606FEB04	1						1	Nasal congestion; Pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219197	04/19/2004	MS				F	02/24/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a female pt who experienced upper respiratory infection, general sinus infection and fever.  The pt received the first dose in Dec 2003.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered in Dec 2003. Dose regimen was 0.5mL (IN).  Concomitant medications were not reported.  The pt received Flumist on an unspecified date in the beginning of December 2003.  She has been experiencing an upper respiratory infection (upper respiratory tract infection) and general sinus infection (sinusitis) every 2 weeks.  No additional information was available at the time of this report.									U					OTH	OTH	UNK	UNK	UNK		HQWYE875709FEB04	1						1	Pyrexia; Sinusitis; Upper respiratory tract infection	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219198	04/19/2004	CA	43.0			M	01/14/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a 43 year old male consumer who experienced a stuffy nose.  At 43 years of age, the pt received a dose on 12/11/03. The pt's concurrent illness includes anxiety.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/11/03.  Dose regimen was 1 dose (IN).  Concomitant therapy included Lexapro (escitalopram) and Xanax (alprazolam).  On 12/11/03, the pt experienced a stuffy nose after receiving Flumist.  He was treated with Claritin.  As of 12/18/03, the stuffy nose had not resolved.  No additional information was available at the time of this report.									U					OTH	PVT	Lexapro; Xanax;	UNK	Anxiety;		HQWYE887423DEC03	1						1	Nasal congestion	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219199	04/19/2004					M	01/19/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a male consumer who experienced a cough and runny nose.  The pt received a dose on 12/13/03.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/13/03.  Dose regimen was 1 dose (IN).  Concomitant medications were not reported.  The pt experienced a cough and runny nose several days following administration of Flumist on 12/13/03.  His wife experienced a similar reaction after receiving Flumist (see related case HQWYE887823DEC03).  The reporter declined to provide additional information and declined to grant permission for follow-up investigation.									U	12/13/2003				OTH	OTH	UNK	UNK	UNK		HQWYE887723DEC03	1						1	Cough; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219200	04/19/2004					F	01/14/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a male consumer regarding his wife who experienced a cough and runny nose.  The pt received a dose on 12/13/03. Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/13/03.  Dose regimen was 1 dose (IN).  Concomitant medications were not reported.  The caller's wife experienced a cough and runny nose following administration of Flumist.  The caller himself, also experienced a similar reaction (see related case HQWYE887723DEC03).  The reporter declined to provide additional information and declined to grant permission for follow-up investigation.									U	12/13/2003				OTH	OTH	UNK	UNK	UNK		HQWYE887823DEC03	1						1	Cough; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219201	04/19/2004	NC	8.0	8		M	01/02/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from the father of an 8 year old male who experienced headache, fever up to 103 deg. F., fatigue and cough.  At 8 years of age, the child received a dose on 12/15/03.  The reporter indicated that the child experiences something similar with cough and fever every winter.  Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 12/15/03. Dose regimen was 1 dose (IN).  Pt was not taking concomitant therapy. The pt experienced headache (headache, fever up to 103 deg. F. (pyrexia), fatigue (fatigue) and cough (cough) on 12/20/03.  The child was treated with ibuprofen.  As of 12/22/03, the headache and fever were much better but the child is still fatigued.  No additional information was available at the time of this report.									U	12/15/2003	12/20/2003	5		PUB	OTH	NONE	UNK	UNK		HQWYE890223DEC03	1						1	Cough; Fatigue; Headache; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219202	04/19/2004	NC	11.0	11		M	01/02/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her 11 year old son who experienced fever.  At 11 years of age, the pt received a dose on 12/18/03.  The pt had sinusitis, cough, and congestion when he received the Flumist.  The physician began therapy with amoxicillin on 12/18/03, since the pt's nasal discharge had changed from clear to yellow.  The pt's medical history also included attention deficit/hyperactivity disorder.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/18/03.  Dose regimen was 1 dose (IN).  Concomitant therapy included Ritalin (methylphenidate hydrochloride) and amoxicillin.  The pt began spiking a fever (pyrexia) of 101-103 deg. F., on  12/19/03.  The mother stated that Tylenol (acetaminophen) does not seem to help the fever very much, and ibuprofen helped more, but you can tell when it wears off.  The mother reported that the pt's cough and congestion were about the same as before he received Flumist.  No additional information was available at the date of this report.									U	12/18/2003	12/19/2003	1	UNK	PVT	PVT	Amoxicillin; Ritalin;	Cough; Congesetion; Sinusitis;	ADHD;		HQWYE890723DEC03	1						1	Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219203	04/19/2004	CA	5.0	5		F	01/23/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal solution (frozen)) was received from a pharmacist regarding a 5 year old female pt who experienced fever of 104 deg. F.  The pt received a dose on 12/17/03. The child received Zyrtec (cetirizine) and albuterol in the summer of 2003 for a cough.  She did not have asthma.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/17/03.  Dose regimen was 0.5mL (IN).  Pt was not taking concomitant therapy.  The pharmacist stated that on 12/19/03, 2 days post-immunization, a father reported that his daughter had a fever of 104 deg. F., when she was picked up from school.  The child's temperature was later rechecked and found to be 102 deg., F.  On follow-up (date not specified), the father reported that his daughter was fine.  No additional information was available at the time of this report.									Y	12/17/2003	12/19/2003	2		OTH	OTH	NONE	UNK	UNK		HQWYE892523DEC03	1						1	Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500031P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219204	04/19/2004	IL	33.0			F	01/23/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal nasal solution (frozen)) was received from a physician regarding a 33 year old female pt who experienced a fever of 102 deg. F., muscle aches, and upper respiratory symptoms (cough).  The pt received a dose on 12/15/03.  The pt's concurrent illness includes allergies.  The pt is otherwise healthy.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/15/03. Dose regimen was 0.5mL (IN).  Concomitant therapy included Flonase (fluticasone propionate) and Singulair (montelukast sodium).  On 12/17/03, 2 days post-immunization, the pt developed a fever of 102 deg. F., muscle aches, and upper respiratory symptoms (cough).  No additional information was available at the time of this report.									U	12/15/2003	12/17/2003	2		OTH	OTH	Flonase; Singulair;	UNK	Hypersensitivity;		HQWYE893923DEC03	1						1	Cough; Myalgia; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219205	04/19/2004	NY				F	02/24/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer reporting that she experienced flu subsequent to receiving Flumist on an unspecified date. Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on an unspecified date. Dose regimen was not provided.  Concomitant medications were not reported.  The pt reported that she experienced flu subsequent to receiving Flumist on an unspecified date.  She recovered.  No additional information was available at the time of this report.									Y					OTH	OTH	UNK	UNK	UNK		HQWYE894211FEB04	1						1	Influenza	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219206	04/19/2004	IL	8.0	8		M	02/20/2004	Follow-up information from the physician's office provided lab results and event outcome (pt recovered).  Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a nurse regarding an 8 year old male pt who experienced a fever of 100.7 deg. F. and a sore throat.  The pt received a dose on 12/20/03.  The pt had no relevant medical history. Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/20/03.  Dose regimen was 0.5mL (IN).  Pt was not taking concomitant therapy.  On 12/21/03, 36 hours post-immunization, the child experienced a fever of 100.7 deg. F. and a sore throat.  On 12/22/03, he was seen by the physician.  Results of a rapid strep test and throat culture were negative.  On 12/24/03, the mother was called with the lab results.  The nurse reported that the child had no further problems.									Y	12/20/2003	12/21/2003	1	Culture throat (12/22/03): negative; Lab test (12/22/03): rapid strep test was negative;	PVT	PVT	NONE	NONE	UNK		HQWYE895823DEC03	1						1	Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500048P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219207	04/19/2004	NY	9.0			M	02/24/2004	Follow-up information received from the physician provided illness at the time of vaccination and even outcome (patient recovered). Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a physician regarding a 9-year-old male patient who developed a cough and fever. The patient received a dose on 15-Dec-2003. Medical History: The patient's concurrent illnesses included pyrexia (fever to 101 deg. F), fatigue and pain (body aches) for 24 hours. Product Details: Indication for Flumist (2003-2004 formula) was immunization. Product was administer on 15-Dec-2003. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event details: On 20-Dec-2003, 5 days post-immunization, the patient developed a cough and a fever. On 22-Dec-2003, the patient was seen by the physician; his fever at that time was 102.5 deg F. The patient recovered.				Y					Y	12/15/2003	12/20/2003	5	No test performed.	PVT	PVT	NONE	Fever to 101 deg F, fatigue, body	Fatigue, Pain, Pyrexia.		HQWYE898323DEC03	1						1	Cough; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500042P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0219208	04/19/2004	NJ	4.0	4		F	01/28/2004	Follow-up information from the physician provided patient's birth weight, changes to concurrent illness and concomitant medication, and event outcome (recovery pending). Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal solution (frozen) was received from a mother regarding her 4-year-old daughter who experienced nasal congestion a few days post-immunization. The patient received a dose on 18-Dec-2003. Medical history: The patient has a past history of acute purulent otitis media. The patient's concurrent illnesses include otitis media and upper respiratory infection. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 18-Dec-2003. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Concomitant therapy included Augmentin (amoxicillin sodium/clavulante potassium) and no other vaccines. Event details: A few days post-immunization with Flumist, the child experienced nasal congestion. The physician reported that recovery is pending.									U	12/18/2003	12/30/2003	12	UNK	PVT	PVT	Augmentin.	Otitis Media and Upper respiratory.	Otitis Media, Upper respiratory Tract infection. Past condition: Otitis media acute.		HQWYE898523DEC03	1						1	Nasal congestion	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219209	04/19/2004	CT	6.0			M	01/02/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a nurse practitioner regarding a 6 year old male pt who experienced flu-like symptoms and diarrhea.  At 6 years of age, the pt received a dose on 12/18/03.  The pt had no relevant medical history.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/18/03.  Dose regimen was 0.5mL (IN). Pt was not taking concomitant therapy.  On 12/22/03, 4 days post-immunization, the child presented to the clinic for treatment of flu-like symptoms, characterized by nasal discharge, cough, fever of 102.9 degrees F., and diarrhea.  No additional information was available at the time of this report.				Y					U	12/18/2003	12/22/2003	4	UNK	PVT	OTH	NONE	NONE	UNK		HQWYE905924DEC03	1						1	Cough; Diarrhoea; Influenza like illness; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0219210	04/19/2004	KY	7.0	7		F	01/14/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her 7 year old daughter who, at the time of administration, experienced nasal congestion and later a sore throat.  The pt received a dose on 12/20/03.  The reporter indicated that the pt had no medical history. Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/20/2003.  Dose regimen was 0.5mL (IN).  Concomitant medications were not reported.  On the day of administration (12/20/03), the pt, as reported by her mother, experienced nasal congestion (nasal congestion).  Two days later, on 12/22/03, she developed a sore throat (pharyngolaryngeal pain).  On 12/23/03, both the nasal congestion and sore throat persisted.  No additional information was available at the time of this report.									U	12/20/2003	12/22/2003	2	UNK	PVT	PVT	UNK	UNK	UNK		HQWYE908424DEC03	1						1	Nasal congestion; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219211	04/19/2004	SC	15.0	15		M	01/02/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her 15 year old son who experienced a bad headache and was very fatigued.  At 15 years of age, the pt received a dose on 12/23/03. The pt's concurrent illness includes ADHD. Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/23/03.  Dose regimen was 0.5mL (IN). Concomitant therapy included Concerta (methylphenidate).  After receiving Flumist at 9:20am on 12/23/03, the pt developed a bad headache and became very fatigued that afternoon.  No additional information was available at the time of this report.									U	12/23/2003	12/23/2003	0	UNK	PVT	PVT	Concerta;	UNK	ADHD;		HQWYE909024DEC03	1						1	Fatigue; Headache	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219212	04/19/2004	IN				U	01/19/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a pt who developed nasal congestion. Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on an unspecified date.  Dose regimen was not provided.  Concomitant medications were not reported.  The pt developed nasal congestion (nasal congestion). The reporter indicated that this event occurred with several pt's; however, they are not presently identifiable.  Additional reports will be generated when identifying information is received.  No additional information was available at the time of this report.									U	12/19/2003			UNK	PUB	PUB	UNK	UNK	UNK		HQWYE909124DEC03	1						1	Nasal congestion	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219213	04/19/2004	PR	5.0	5		F	03/18/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 5 year old female pt who experienced fever 102 deg F..At 5 years of age, the pt received a dose on 12/16/03. The child had no relevant medical history. Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/16/03.  Dose regimen was 0.5mL (IN). Pt was not taking concomitant therapy. The pt experienced fever 102 deg F (pyrexia) on 12/18/03.  The pt was treated with Tylenol (acetaminophen) and recovered after 4 days.  The physician was not notified.  No additional information was available at the time of this report.Follow UP: follow up informaiton received from the physician medically confirmed events.									Y	12/16/2003	12/18/2003	2	UNK	PVT	PVT	NONE	NONE	UNK	~Influenza (Seasonal) (FluMist)~~0.00~In Sibling	HQWYE941317MAR04	1						1	Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219214	04/19/2004	VA	21.0	21		M	03/09/2004	A consumer reported that her 21 year old son received a dose of Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on 12/11/03 and developed a fever of 99.7 deg. F. and a runny , watery, yellow discharge from his right nostril. The reporter indicated that the pt has allergies.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/11/03.  Dose regimen was 1 dose. The pt was not taking concomitant medications.  The pt received a dose of Engerix-B (hepatitis B vaccine) on 11/11/03 and 12/11/03.  On 12/11/03, a male pt received a dose of Flumist and developed a fever of 99.7 deg. F.  On 12/25/03, the pt developed a runny, watery, yellow discharge from his right nostril.  He was treated with Cefzil (cefprozil) for the infection.  As of 12/29/03, the fever has resolved, however, the nasal discharge persists.									U	12/11/2003	12/11/2003	0	UNK	PVT	PVT	NONE	UNK	Hypersensitivity;		HQWYE993931DEC03	1						1	Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219215	04/19/2004	CA	39.0	39		F	03/16/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a 39 year old female pt who experienced blood in her urine.  At 39 years of age, the pt received a dose on 12/15/03.  The pt had no relevant medical history.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/15/03.  Dose regimen was 1 dose (IN). Pt was not taking concomitant therapy.  On 12/18/03, the pt had two occurrences of blood in her urine (blood urine).  She stated that when the Flumist was administered in her left nostril, it all came out as a stream (pharmaceutical product complaint) and all drained down the throat and was swallowed.  When it was administered in the right nostril, it came out as a spray, but some of it drained down her throat.  She wanted to know if swallowing Flumist could cause blood in the urine.  The pt indicated that she did not have any blood in her urine on 12/19/03. She stated that she has scheduled an appointment to see her physician.  No additional information was available at the date of this report.									U	12/15/2003	12/18/2003	3	UNK	OTH	PVT	NONE	NONE	UNK		HQWYE859022DEC03	1						1	Blood urine; Postnasal drip	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219216	04/19/2004	CA				F	02/24/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a female pt who experienced sinusitis and bronchitis.  The pt received a dose on an unspecified date. The pt has a past history of influenza (The pt developed the flu following administration of a flu shot 25 years ago).  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on an unspecified date.  Dose regimen was 1 dose. Concomitant medications were not reported.  The pt experienced sinusitis (sinusitis) and bronchitis (bronchitis) on an unspecified date.  No additional information was available at the time of this report.									U				UNK	OTH	OTH	UNK	UNK	Influenza;		HQWYE879510FEB04	1						1	Bronchitis; Sinusitis	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219217	04/19/2004	GA	6.0	6		F	01/02/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her 6 year old daughter who experienced a runny nose and rash on her back.  At 6 years of age, the pt received a dose on 12/12/03. The pt had no relevant medical history. Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/12/03.  Dose regimen was 0.5mL (IN). Pt was not taking concomitant therapy.  On 12/13/03, 1 day post-immunization, the child experienced a runny nose which lasted for 2 days.  On 12/17/03, she developed a rash on her back. The rash persisted as of 12/19/03.  No additional information was available at the time of this report.									U	12/12/2003	12/13/2003	1	UNK	PVT	PVT	NONE	NONE	UNK		HQWYE892623DEC03	1						1	Rash; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219218	04/19/2004					U	01/19/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a nurse regarding several nursing home pt's who experienced influenza-like symptoms, after possible accidental exposure to health care workers or family members who received Flumist.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) therapy were not provided. Concomitant medications were not reported.  Several nursing home pt's became sick with influenza-like symptoms, after possible accidental exposure to health care workers or family members who received Flumist.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQWYE893023DEC03	1						1	Influenza like illness	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219219	04/19/2004	MA				F	01/19/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a nurse who experienced coughing, congestion, exposure to vaccine and condition aggravated.  The pt's concurrent illness includes asthma. Flumist (2003-2004 Formula) therapy was not indicated for the nurse.  Concomitant medications were not reported.  A nurse, with a history of asthma, experienced increased coughing (cough) and congestion (nasal congestion) beginning on 12/16/03.  The nurse did not receive the vaccine.  She administers Flumist (accidental exposure) and experienced an increase in her coughing (condition aggravated) and congestion (nasal congestion).  No additional information was available at the time of this report.									U		12/16/2003		UNK	OTH	OTH	UNK	UNK	Asthma;		HQWYE893123DEC03	1						1	Condition aggravated; Cough; Nasal congestion	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219220	04/19/2004	TN	43.0			M	02/05/2004	Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a pharmacist regarding a 43 year old male pt who experienced a runny nose, congestion, red/watery eyes, sneezing, cough, fever (about 100 degrees), feeling achy and dizziness.  The pt received a dose on 12/08/03.  Pt stated that he had no medical history.  He signed a Vaccine Information Statement for Flumist questionnaire provided by the pharmacy flu vaccine program, stating he had no contraindications to receiving Flumist.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/08/03.  Dose regimen was 1 dose (IN).  Pt was not taking concomitant therapy. On 12/08/03, the pt experienced a runny nose immediately following Flumist administration.  He subsequently developed congestion, red/watery eyes, sneezing, a cough, fever (about 100 degrees), and felt achy and dizzy.  Between 12/11/03 and 12/12/03, his symptoms peaked and continued through 12/15/03.  He took Theraflu (caffeine, codeine phosphate, paracetamol, piperylone maleate) for symptom relief.  As of 12/19/03, the pt reported that he was over it.  No additional information was available at the time of this report.									Y	12/08/2003			UNK	PVT	PVT	NONE	UNK	UNK		HQWYE893223DEC03	1						1	Cough; Dizziness; Lacrimation increased; Nasal congestion; Ocular hyperaemia; Pain; Pyrexia; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~500018P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219221	04/19/2004	CA	41.0	41		F	01/14/2004	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal nasal solution (frozen) was received from a 41-year-old female consumer who experienced severe joint pain. At 41 years of age, the patient received a dose on 18-Dec-2003. Medical History: The patient's concurrent illness includes rheumatoid arthritis. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 18-Dec-2003. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Concomitant therapy included ibuprofen (manufacturer unknown). Event Details: on 18-Dec-2003, hours after receiving Flumist, the patient developed severe joint pain. She took ibuprofen with no relief. As of 19-Dec-2003, the pain continued. Related case(s): See related case(s): HQWYE914824DEC03 (In 2002, the patient received a flu shot (manufacturer unknown), and in the first 24 hours, she experienced severe joint pain.) No additional information was available at the time of this report.									N	12/18/2003	12/18/2003	0	UNK	PVT	PVT	Advil.	UNK	Concurrent Conditions: Rheumatoid arthritis.	severe joint pain~Influenza (Seasonal) (no brand name)~~0.00~In Patient	HQWYE893323DEC03	1						1	Arthralgia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219222	04/19/2004	RI	36.0	36		M	01/19/2004	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal nasal solution (frozen)) was received from a nurse regarding a 36-year-old male patient who experienced feeling like his chest is on fire. At 36 years of age, the patient received a dose on 16-Dec-2003. Medical History: The patient had no relevant medical history. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 16-Dec-2003. Dose regimen was 1 dose (intranasal). Concomitant Therapy: Concomitant medications were not reported. Event details: On 19-Dec-2003, 3 days post-immunization, the patient experienced a feeling like his chest is on fire. The patient was advised to see the physician at the office. No additional information was available at the time of this report.									U	12/16/2003	12/19/2003	3	UNK	OTH	OTH	UNK	UNK	UNK		HQWYE894823DEC03	1						1	Chest pain	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219223	04/19/2004	VA	7.0	7		F	01/02/2004	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her 7-year-old daughter who experienced a severe red, sore throat and a fever of 100 degrees. At 7 years of age, the patient received a dose on 15-Dec-2003. Medical History: The patient had no relevant medical history. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 15-Dec-2003. Dose regiment was 0.5 mL (intranasal). Concomitant therapy: Patient was not taking concomitant therapy. Event Details: On 18-Dec-2003, 3 days post-immunization, the child experienced a severe red, sore throat and a fever of 100 degrees. As of 19-Dec-2003, her symptoms persisted. Of note, the patient's brother had strep throat, and had tested positive for strep on the day of his sister's vaccination. No additional information was available at the time of this report.									N	12/15/2003	12/18/2003	3	UNK	PVT	PVT	NONE	NONE	UNK		HQWYE894923DEC03	1						1	Erythema; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219224	04/19/2004	CA	8.0	8		M	02/13/2004	Follow-up information from the physician revealed that the child received no other vaccines within 4 weeks of Flumist administration. Information regarding Flumist (2003-2004 Formula) (Influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a mother regarding her 8-year-old son who experienced vomiting, diarrhea and nausea. The patient received a dose on 18-Dec-2003. Medical History: The child had no medical history. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 18-Dec-2003. Dose regimen was 0.25 mL in each nostril. Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: On 18-Dec-2003, 5 hours after receiving Flumist, the child developed nausea, vomiting and diarrhea. The nausea continued through the night until 5:00 am on 19-Dec-2003. As of 19-Dec-2003, the diarrhea was subsiding and the child was experiencing very loose stools.  No medications were taken for the diarrhea or vomiting. Of note, the child's mother developed severe joint pain after receiving a dose of Flumist (2003-2004 formula) on 18-Dec-2003 (see MCN: HQWYE893323DEC03).									U	12/18/2003	12/18/2003	0	UNK	PVT	PVT	NONE	NONE	UNK		HQWYE895123DEC03	1						1	Diarrhoea; Nausea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219225	04/19/2004	NC	22.0			M	01/02/2004	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a physician regarding a 22-year-old male patient who experienced cough, nausea, diarrhea and an uncomfortable feeling in his legs, from his hips down to his toes. At 22 years of age, the patient received a dose on 12-Dec-2003. Medical History: The patient had no relevant medical history. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 12-Dec-2003, at a pharmacy. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: On 13-Dec-2003, 1 day post immunization, the patient developed a cough. The next day he experienced nausea and diarrhea. On 15-Dec-2003, he developed this sensation from his hips down to his toes. The patient explains it as an uncomfortable feeling; he is not comfortable standing, sitting or walking. He feels as if he has to change his position to get comfortable, but can not. He presented to an urgent care facility with this chief complaint, while traveling. No additional information was available at the time of this report.				Y					U	12/12/2003	12/15/2003	3	UNK	OTH	OTH	NONE	NONE	UNK		HQWYE895423DEC03	1						1	Cough; Diarrhoea; Gait disturbance; Nausea; Restless legs syndrome	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0219226	04/19/2004	MD	32.0	32		F	01/05/2004	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a 32-year-old nursing mother who experienced headache, runny nose, body aches and feeling tired. At 32 years of age, the patient received a dose on 17-Dec-2003. Medical History: The patient had no relevant medical history. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 17-Dec-2003. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: On 18-Dec-2003, the patient, a nursing mother, experienced headache, runny nose, body aches and was feeling tired. As of 19-Dec-2003, all events were unresolved. The subject stated I wasn't supposed to have Flumist because I'm breastfeeding. Related Case: See related caseHQWYE871922DEC03 (baby case). No additional information was available at the time of this report.									N	12/17/2003	12/18/2003	1	UNK	PVT	PVT	NONE	NONE	UNK		HQWYE895723DEC03	1						1	Fatigue; Headache; Medication error; Pain; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219227	04/19/2004	MN	8.0			M	01/05/2004	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a father regarding his 8-year-old son who experienced a rash, described by a nurse as Fifth disease. At 8 years of age, the patient received a dose on (date not specified). Medical History: Relevant medical history was not provided. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on (date not specified). Dose regimen was 1 dose. Concomitant Therapy: Concomitant medications were not reported. Event Details: On 19-Dec-2003, post-immunization, the child developed a rash, first on his cheeks, and then on the rest of his body, mainly his arms and legs. The rash was described by a nurse as Fifth disease. No additional information was available at the time of this report.									U		12/19/2003		UNK	OTH	OTH	UNK	UNK	UNK		HQWYE896823DEC03	1						1	Rash	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219228	04/19/2004	MD	20.0	20		F		Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a healthcare professional regarding a 20-year-old female patient with systemic lupus erythematosus, who experienced nasal irritation and nasal dryness. The patient received a dose on 15-Dec-2003. Medical History: The patient's concurrent illness includes systemic lupus erythematosus (not currently receiving medication for Lupus). Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 15-Dec-2003. Dose regimen was 1 dose (intranasal). Concomitant Therapy: Concomitant therapy included tetanus and diptheria toxoids (manufacturer unknown) administered on 16-Dec-2003. Event Details: On 15-Dec-2003, subsequent to Flumist administration, the patient experienced nasal irritation (nasal passage irritation), including dryness (nasal dryness). The reported wanted to know if the patient was at risk for any specific complications due to the fact that she has a history of lupus. The patient's rhematologist is upset that FluMist was given to a patient with lupus (medication error). No additional information was available at the time of this report.									U	12/15/2003	12/15/2003	0	UNK	PVT	PVT	NONE	UNK	Systemic lupus erythematosus.		HQWYE9022524DEC03	1						1	Medication error; Nasal congestion	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219229	04/19/2004	OH	33.0	33		M	01/02/2004	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a 33-year old male consumer who experienced 24 hour flu, nose, sinus and ear congestion. At 33 years of age, the patient received a dose on 15-Dec-2003. Medical History: The patient had a slight cold prior to receiving Flumist on 15- Dec-2003, with a past history of ear infections. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 15-Dec-2003. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Concomitant medications were not reported. Event Details : On 22-Dec-2003, 1 week post-immunization, the patient experienced a 24 hour flu, for which he took Nyquil (detromethorphan hydrobromide and doxylamine succinate and ephedrine sulfate and ethanol and paracetamol). The 24 hour flu continued as nose, sinus and ear congestion. He was scheduled to see the physician in 1 week. No additional information was available at the time of this report.									N	12/15/2003	12/22/2003	7	UNK	PVT	PVT	UNK	Cold	Ear Infection.		HQWYE907724DEC03	1						1	Drug ineffective; Infection; Influenza; Nasal congestion; Sinus congestion	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219230	04/19/2004	OH	20.0	20		M	01/19/2004	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a mother (a nurse) regarding her 20-year-old son who felt sick immediately following Flumist and later developed a fever. At 20 years of age, the patient received a dose the week of 08-Dec-2003. Medical History: The patient had a slight cold and little runny nose before receiving Flumist. Product Details: Indication for Flumist (2003-2004) was immunization. Product was administered the week of 08-Dec-2003 at health center. Dose regimen was 1 dose (intranasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: the patient felt sick immediately following Flumist administration. On 20-Dec-2003, he reported feeling terrible, developing a fever of 102.6, which increased to 104.4 on the night of 21-Dec-2003. He was treated with Tylenol (acetaminophen) and Advil (ibuprofen), but the fever continued to rise. On the evening of 21-Dec-2003, he was taken to the emergency room at the hospital. He was prescribed Avelox (moxifloxacin) for a possible bacterial infection, and sent home. As of 23-Dec-2003, he was beginning to feel better. Test results: On 21-Dec-2003, chest x-ray results were negative for pneumonia. No additional information was available at the time of this report.				Y					U	12/01/2003	12/20/2003	19	Test Name: Chest X-raay 12/21/2003, results: negative for pneumonia.	OTH	OTH		UNK	Nasopharyngitis; Rhinorrhoea		HQWYE909224DEC03	1						1	Bacterial infection; Malaise; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0219231	04/19/2004	NY	6.0	6		M	01/14/2004	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a mother regarding her 6-year-old son who experienced fever up to 104.3 F, cold symptoms, runny nose, cough, loss of appetite and eye redness. At 6 years of age, the patient received a dose on 13-Dec-2003. Medical History: The patient had no relevant medical history. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 13-Dec-2003. Dose regiment was 0.5 mL (intranasal). Concomitant Therapy: Concomitant medication were not reported. Event Details: On 16-Dec-2003, 3 days post-immunization, the child began to have a high fever 101-102 F., cold symptoms, runny nose, cough, and his eyes became red. His fever went as high as 104.3 F. He was seen by the pediatrician, and diagnostic test (see below) were within normal limits. As of 23-Dec-2003, the child's fever was 102 F., his eyes had cleared, but he still had a cough, runny nose and loss of appetite. Test results: His chest x-rays and complete blood count were clear and strep test was negative. No additional information was available at the time of this report.				Y					U	12/13/2003	12/16/2003	3	Chest X-ray 12/00/2003 chest x-ray is clear. Culture 12/00/2003 strep test was negative. Full Blood count, CBC is clear.	OTH	PVT	NONE	NONE	UNK		HQWYE920529DEC03	1						1	Anorexia; Cough; Ocular hyperaemia; Pharyngitis; Pyrexia; Rhinitis; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0219232	04/19/2004	PA	8.0	8		M	03/18/2004	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 8-year-old male patient who experienced fever 102 deg F., secondary sinus infection, headache and GI symptoms. At 8 years of age, the patient received the second dose on 18-Feb-2004. Medical History: the child had no relevant medical history. The child was reported as fine following receipt of her first dose of Flumist on 16-Dec-2003. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 18-Feb-2004. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: On 20-Feb-2004, he developed a fever of 102 deg F. (pyrexia) for 2 days followed by a secondary sinus infection (sinusitis). He was treated with Tylenol (acetaminophen) and recovered. In March 2004, he again developed a fever of 102 deg F. with headache (headache) and GI symptoms (gastrointestinal disorder). He was treated with Tylenol (acetaminophen) and recovered by 16-Mar-2004. The reported indicated that the physician was not notified of these events. No additional information was available at the time of this report. Follow up: follow up information received from the physician provided sibling immunization history and medically confirmed the event.									Y	02/18/2004	02/20/2004	2	UNK	PVT	PVT	NONE	NONE	UNK	~Influenza (Seasonal) (FluMist)~~0.00~In Sibling	HQWYE940817MAR04	1						1	Gastrointestinal disorder; Headache; Infection; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219233	04/19/2004	PA	7.0	7		F	03/18/2004	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a consumer regarding a 7-year-old female patient who experienced fever 102 deg. F., headache and GI symptoms. At 7 years of age, the patient received the second dose on 18-Feb-2003. Medical History: The child had no relevant medical history. The child was reported as fine following receipt of her first dose of Flumist on 16-Dec-2003. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 18-Feb-2004. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: The patient developed a fever of 102 deg. F. (pyrexia) on 20-Feb-2004. She was treated with Tylenol (acetaminophen) and recovered after 3 days. In March 2004, she again developed a fever of 102 deg. F. with headache (headache) and GI symptoms (gastrointestinal disorder). She was treated with Tylenol (acetaminophen) and recovered by 16-Mar-2004. The reporter indicated that the physician was not notified of these events. No additional information was available at the time of this report.  Follow up: information received from the physician provided sibling immunization history and medically confirmed the event.									Y	02/18/2004	02/20/2004	2	UNK	PVT	PVT	NONE	NONE	UNK		HQWYE941017MAR04	1						1	Gastrointestinal disorder; Headache; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219234	04/19/2004	MA	34.0	34		F	02/24/2004	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from 34-year-old female who received a dose of Flumist 08-Jan-2004, and experienced an inability to function, headache front and back of head and on her face, vertigo and ear pain. The patient had a sinus infection concurrent with Flumist administration. Medical History: The patient's concurrent illnesses include hypersensitivity (allergies) and sinusitis with a past history of migraines (15 years ago). Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 08-Jan-2004. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Concomitant therapy included Flonase (fluticasone propionate) and Zyrtex (cetirizine hydrochloride). Event Details: On 09-Jan-2004, the patient experienced headaches that exploded in the front and back of her head, and her face (headache); along with vertigo (vertigo) and she was unable to function (activities of daily living impaired) for two weeks. She was treated with Ceclor for 10 days, Biaxin for 7 days, Levaquin for 3 days along with Sudafed as treatment for her sinus condition that there was no infection. As of 10-Feb-2004, her headaches persisted along with ear pain. She is currently being treated with Fiorinal. Test Results: Computerized tomogram (results: Negative) was done on an unspecified date. No additional information was available at the time of this report. Follow up: information received on 06APR2004 indicated that the patient had sinusitus at the time of vaccination, provied treatment medication and patient's recovery status. A recent CAT scan was performed with negative results. She indicated taht her physician stated that there was no infection. As of 10FEB2004, her headaches persisted with pain. She is currently being treated with Fiorinal. The pt had sinusitis at the time of vaccination and was treated with Ceclor. The patient recovered.				Y					Y	01/08/2004	01/09/2004	1	Computerized tomgram: Negative.	PVT	PVT	Flonase, Zyrtec., Ceclor	UNK	Concurrent Conditions: Hypersensitivity, Sinusitis, Past Conditions: Migraine, Sinusitis		HQWYE943812FEB04	1						1	Ear pain; Headache; Hypokinesia; Pain; Vertigo	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0219235	04/19/2004	NJ	6.0	5		F	03/02/2004	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a consumer regarding a 6-year old female patient who experienced fever of 101.2, cough and phlegm. At 6 years of age, the patient received the first dose on 12-Dec-2003. Medical History: The patient's concurrent illness includes eczema. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 12-Dec-2003. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Concomitant therapy included Elidel (pimecrolimus). Event Details: The patient received Flumist 0.5 mL on 12-Dec-2004 with no immediate adverse effects; she did not receive a booster dose. On 09-Feb-2004 the patient experienced fever of 101.2 (pyrexia) and cough (cough). She was treated with Pedia Care and Advil. On 10-Feb-2004 the patient's temperature was normal but she still had a little cough with phlegm (throat secretion increased). No additional information was available at the time of this report.  FOLLOW UP: information was received from a physician attributing the patient's fever to an ear infection and reporting administration of a second dose of Flumist with no reaction. On 24FEB2004, the pt received her second dose of Flumist with no reaction.									U	12/12/2003	02/09/2004	59	UNK	PVT	PVT	Elidel	UNK	Concurrent Conditions: Eczema		HQWYE944312FEB04	1						1	Cough; Otitis media; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219236	04/19/2004	NJ				F	02/09/2004	Information regarding FluMist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a 45-year-old female who did not receive FluMist vaccine but experience subsequent accidental exposure and development of and adverse event on 28-Dec-2003. Medical History: None reported. Product Details: Indication, dose and dates of FluMist (2003-2004 Formula) therapy were not provided. The reported did not receive Flu Mist. Concomitant Therapy: Reporter was not taking concomitant therapy. Event Details: A 45-year old female reported that she developed a sore throat (pharyngolaryngeal pain) and nasal congestion (nasal congestion) on 28-Dec-2003, after six hour visit with a person who had received FluMist on an unspecified dated (accidental exposure). The reporter indicated that the FluMist recipient, did not seem to be sick. and stated, your product made me sick. Manufacturer's comment: The reporter declined to provide information necessary for follow-up. No additional information was available at the time of this report.									N		12/28/2003		UNK	OTH	OTH	NONE	UNK	UNK		HQWYE965120DEC03	1						1	Infection transmission via personal contact; Malaise; Nasal congestion; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219237	04/19/2004	MI	47.0	47		F	01/14/2004	Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a 47-year old female consumer who experienced fever, chills, body aches, abdominal pain, vomiting and nausea. The patient received a dose on 23-Dec-2003. Medical History: The patient has a past history of sarcoidosis (lung condition (not certain), working diagnosis Sarcoid, total remission). Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 23-Dec-2003. Dose regiment was 1 dose (intranasal). Concomitant Therapy: Concomitant therapy included prednisone, Synthroid (levothyroxine sodium), Lasix (furosemide), multivitamins and Caltrate (calcium carbonate tablet). Event Details: On 23-Dec-2003, within 12-16 hours of receiving Flumist, the patient developed fever, chills, body aches, abdominal pain, vomiting and nausea. At the time of this report, the patient explained that she still was a a little shaky due to the symptoms originally reported. No additional information was available at the time of this report.									U	12/23/2003	12/23/2003	0	UNK	PVT	OTH	Caltrate, Lasix, Multivitamins, Prednisone, Synthroid.	UNK	Past Conditions: Sarcoidosis.		HQWYE956630DEC03	1						1	Abdominal pain; Chills; Nausea; Pain; Pyrexia; Tremor; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219238	04/19/2004	AZ	46.0	46		M	03/09/2004	Follow up information received from the reported on 27-Feb-2004, provided further clarification of the event and treatment plan. Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a physician regarding a 46-year-old male patient who experienced mild swelling of the right side of his face, lips, right periorbital swelling, mild pink eye and slightly swollen ear canals on 10-Dec-2003, within a few hours post immunization of Flumist.... Medical History: The patient's concurrent illness includes seasonal allergy (hay fever). Product Details: Indications for Flumist (2003-2004 Formula) was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant Therapy: Concomitant therapy included Paxil (paroxetine hydrochloride). Event Details: About 12 hours post immunization, on 10-Dec-2003, the patient experienced mild right facial and lip swelling (swelling face), mild right periorbital swelling (eye swelling), pink eye (conjuctivitis allergic), and slightly swollen ear canals (auricular swelling). The physician assessed the event as an allergic reaction to Flumist. (hypersensitivity). The patient was treated with cool compresses and prescribed Benadryl 50 mg initially and ten 25 mg every 6 hours PRN; along with Naphcon A ophthalmic solution and Zyrtec 10 mg QD. The physician also noted gentamycin ophthalmic solution. The reporter stated that the symptoms resolved in 36 hours.				Y					Y	12/10/2003	12/10/2003	0	UNK	OTH	OTH	Paxil	UNK	Concurrent Conditions: Seasonal allergy		HQWYE966430DEC03	1						1	Conjunctivitis; Eye oedema; Face oedema; Hypersensitivity	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0219239	04/19/2004	DC	57.0	57		M	01/28/2004	A 57-year-old male consumer reported that he received a dose of Flumist (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on an unspecified date in December 2003 and developed a runny nose, stuffy nose, impaired sense of smell and impaired sense of taste. Medical History: The patient has no known drug allergies. He has a history of seasonal allergies, however, the reported indicated that he was asymptomatic prior to the Flumist vaccination. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. The product was administered approximately three weeks prior to 30-Dec-2003. Concomitant Therapy: Concomitant therapy included Atenolol. Event Details: On a unspecified date in December 2003, a male patient developed a runny nose, stuffy nose, impaired sense of smell, and impaired sense of taste after receiving a dose of Flumist. He stated he could taste the Flumist in his mouth right away after vaccination. The patient indicated that the runny nose, stuffy nose, impaired sense of smell and impaired sense of taste occurred almost immediately after administration. He also noticed that his sense of smell and taste was affected in sensing fragrances associated with certain foods. Treatment included over-the counter antihistamines and Sudafed, however, the patient stated that his runny nose and congestion were not relieved with the use of these products. The patient described his nostrils as sometimes very dry and sometimes very wet. As of 30-Dec-2003, the reported adverse events persist. The reported indicated he was in the process of contacting his physician regarding the adverse events. No additional information was available at the time of this report.									N	12/01/2003	12/01/2003	0		PVT	OTH	Atenolol.	UNK	Concurrent Conditions: Seasonal allergy.		HQWYE993231DEC03	1						1	Dysgeusia; Nasal congestion; Nasal dryness; Parosmia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219240	04/19/2004	CA	49.0	49		M		Follow up information received from the reporter on 01-Mar-2003 provided patient's date of birth and lot number. Information regarding FluMist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a 49-year-old male who received a dose of the vaccine and subsequently developed the flu. Medical History: Relevant medical history was not provided. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on an unspecified date. Dose regiment was not provide. Concomitant Therapy: Concomitant medications were not reported. Event Details: The patient experienced the flu (influenza). No additional information was available at the time of this report.									U	11/17/2003			UNK	OTH	OTH	UNK	NONE	UNK		HQWYE102618FEB04	1						1	Drug ineffective; Influenza	FLUN3~MEDIMMUNE VACCINES, INC.~500018P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219241	04/19/2004	FL	9.0	9		F	01/19/2004	Pyrexia/ Fever. Rhinorrhoea/ Runny Nose. Headache. Information regarding Flumist 2003-2004 influenza vaccine, live intranasal 2003-4 formula nasal solution frozen was received from a parent regarding her 9 year old daughter who received a dose of 02-Jan-2004 and later developed fever, runny nose and headache. The patient developed a fever of over 99 degrees F-pyrexia, runny nose (rhinorrhea) and headache on 04-Jan-2004. She was given Tylenol which reduced the fever. As of 05-Jan-2004, the reporter stated that the fever came down, the headache resolved but the runny nose persisted. No additional information was available at the time of this report. The reporter declined to provide a complete address which does not permit follow investigation.									U	01/02/2004	01/04/2004	2	UNK	PUB	OTH	UNK	UNK	Bronchitis, Pneumonia		HQWYE116006JAN04	1						1	Headache; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219244	04/19/2004					M	03/09/2004	Ear information, Condition aggravated. Information regarding Flumist 2003-4 formula influenza virus vaccne live intranasal 2003-4 formula nasal solution frozen was received from a consumer regarding a ten year old male patient who experienced more frequent ear infections. The patient received a dose on an unspecified date. The pt experienced more frequent ear infections and conditioned aggravated since receiving Flumist (date unspecified). No additional information was available at the time of this report.									U				UNK	UNK	UNK			Ear infection		HQWYE309925FEB04	1						1	Condition aggravated; Otitis media	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219245	04/19/2004	CA				F	03/16/2004	Nasal congestion; Unevaluable event. Information regarding Flumist 2003-4 Formula influenza virus vaccine, live intranasal 2003-4 formula nasal solution frozen was received from a female consumer who received a dose on an unspecified date and experienced an adverse event. A consumer reported that she developed a stuffy nose, nasal congestion and upper respiratory symptoms (unevaluable event) after receiving a dose of Flumist on an unspecified date. No additional information was available at the time of this report.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQWYE321914JAN04	1						1	Nasal congestion; Respiratory disorder; Unevaluable event	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219246	04/19/2004	TN	30.0	30		F	03/09/2004	Cough/Persistent non-productive cough; Throat irritation. A 30 year old female consumer reported that she received a dose of Flumist influenza virus vaccine, live intranasal 2003-4 formula nasal solution frozen on 12-Dec-2003 and developed a persistent cough and scratchy throat. on 01-Jan-2004, the patient experienced a perisistent cough and scratchy throat/ throat irritation. At the end of January 2003, she was examined by a physician, a diagnosis of allergies was made. She was treated with Claritan (loratadine) and Entuss (guifenesin/hydrocodone bitartrate) cough syrup. The reporter indicated that these medications helped the throat problem, however she continued taking Entuss. The reporter indicated that her physician is not aware that she received Flumist. As of 26-Feb-2004, the cough persists. No further information was available at the time of this report.				Y					U	12/12/2003	01/01/2004	20	UNK	PUB	OTH	CEPHALEXIN	UNK	Hypersensitivity/Allergy; Hypertonic		HQWYE445327FEB04	1						1	Cough; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0219247	04/19/2004	FL	4.0	4		M	03/11/2004	Influenza. Tremor. Anorexia. Difficulty in walking. Unevaluable event. Information regarding flumist 2003-4 formula influenza virus vaccine, live intranasal 2003-4 formula nasal solution frozen was received from a mother regarding her 4 year old son who experienced the flue. At four years of age, the patient received the first dose on 15-Dec-2003. On 20-Dec-2003, the mother reported that her son had a fever of 103.6 F and was shaking/tremor, couldn't get up/unevaluable event or walk/difficulty walking and wouldn't eat/anorexia.  He was treated with Children's Motrin (ibuprofen), which would reduce the fever a little, but still over 101 F. On 22-Dec-2003, the child was seen by a physician. A nasal swab was taken, which showed that he had the flu. The child was treated with Tamiflu (oseltamivir). The mother stated that the patient was much better after six days of Tamiflu therapy. However, the child remained sick and weak for at lest three weeks,  before all symptoms completely resolved. No additional information was available at the time of this report.				Y					Y	12/15/2003	12/20/2003	5	virus serology 12/16/2003 nasal swab revealed the flu	PVT	PVT	NONE	UNK	Asthma		HQWYE504303MAR04	1						1	Anorexia; Difficulty in walking; Drug ineffective; Influenza; Laboratory test abnormal; Pyrexia; Tremor; Viral infection	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0219248	04/19/2004	MA	23.0	23		M	02/05/2004	Pyrexia/Fever; Paryngolaryngeal pain/ Throat sore; Pain/Generalized aching. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 23 year old male patient who experienced fever of 102 degrees, sore throat and body aches. At 23 years of age, the patient received the first dose on 18-Dec-2003. The patient received flumist on 18-DEC-2003 and did not experience any symptoms immediately following administration of the vaccine. On 18-Jan-2004 the patient experienced fever of 102 degrees (pyrexia), sore throat (pharyngolaryngeal pain) and body aches (pain). He was treated with Tylenol but low-grade fever, sore throat and body aches persisted as of 22-Jan-2004.									N	12/18/2003	01/18/2004	31	UNK	PVT	PVT	NONE	COLD	UNK		HQWYE541923JAN04	1						1	Pain; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219249	04/19/2004	NY	9.0			M	03/16/2004	Tongue Discoloration; Accidental overdose (therapeutic agent); Medication error; Drug maladministration. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 9 year old male patient who experienced tongue discoloration after he received a second dose of Flumist on 17-Feb-2004. The patient received the first dose on 05/Jan/2004. On 17-Feb-2004 the patient received a second dose of flumist (accidental overdose)/medication error. The first dose of vaccine was given on 05-Jan-2004. The doctor's office misread the flyer that accompanied the flumist and administered the second dose since the patient had not been given a flu shot in the past. Immediately after administration of the second dose, the patient's tongue turned blue/ tongue discoloration. See related case HQWYE666209MAR04 (adverse event, non expedited) and HQWYE666309MAR09 (adverse event, non-expedited. No additional information was available at the time of this report. Follow Up: information pertaining to the reported event of tongue discoloration was received from the reporter.									U	02/17/2004	02/17/2004	0	UNK	PVT	OTH	NONE	NONE	UNK		HQWYE568304MAR04	1						1	Accidental overdose; Medication error; Tongue discolouration	FLUN3~MEDIMMUNE VACCINES, INC.~500044P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219250	04/19/2004	ID	4.0	4		M	01/23/2004	Vomiting; Medication Error/ Maladministration; Diarrhea. Follow-up information received from the pediatrician provided adverse event details, recovery status, patient date of birth, revised physician address, count of vaccine adminsitration and vaccine lot number. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding 4 year old male who developed vomiting and diarrhea after he was given Flumist inadvertently, due to human error. At 4 years of age, the patient received a dose on 24-Oct-2003. On 26-Oct-2003, two days post vaccination, the child developed vomiting and diarrhea, which lasted about 24 hours. He recovered. The patient was given Flumist inadvertently, due to human error /medication error.									Y	10/24/2003	10/26/2003	2	UNK	OTH	OTH	UNK	UNK	UNK		HQWYE579028OCT03	1						1	Diarrhoea; Medication error; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500002P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219251	04/19/2004	OH	35.0	35		F	02/05/2004	Influenza like illness/Flu-like symptoms; Pharygolaryngeal pain/ Sore throat; Ear pain/Ear ache; Rigors/chills; Pain/Ache NOS; Pyrexia/Fever. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a 35 year old female consumer who experienced flu-like sympttoms, sore throat, earache, chills, body aches and fever between 100-101. At 35 years of age, the patient received a dose on 15-Jan-2004. On 21-Jan-2004, 6 days post-immunization, the patient experienced flu-like symptoms (influenza like illness) characterized by sore throat (pharyngolaryngeal pain); earache/pain, chills/rigors,  body aches/pain and fever between 100-101 degrees/pyrexia. As of 26-Jan-2004, the patient's symptoms were getting worse.									U	01/15/2004	01/21/2004	6	UNK	OTH	PUB	NONE	NONE	UNK		HQWYE585727JAN04	1						1	Chills; Ear pain; Influenza like illness; Pain; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219252	04/19/2004	NY	23.0			F	03/17/2004	Pyrexia/ Slight Fever; Medicaiton error/Inappropriate dose of drug administered; Influenza like illness (flu-like symptoms). Follow up information received form the healthcare provider, on 15-Mar-2003, provided additional demographics, vaccination details, including date and lot number, additional details of adverse event, including date, and recovery status, and reported previous history, allergies and birth defects as none. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a nurse regarding a 23 year old female patient who received a partial dose on 21-Jan-2004 developed a mild fever and flu like symptoms. A nurse reported that a 23 year old female patient refused the second half of a divided dose of flumist (medication error) on 21-Jan-2004. On 24-Jan-2004, she developed a mild fever/ pyrexia and flulike symptoms (influenza like illness) which were described as stuffy nose, aches and tiredness. The reporter indicated that the patient received over the counter treatment for mild fever and aches. The reporter also indicated, that the patient's signs and symptoms lasted 4 days and she recovered.									Y	01/21/2004	01/24/2004	3	UNK	OTH	OTH	UNK	UNK	UNK		HQWYE660229JAN04	1						1	Fatigue; Influenza like illness; Medication error; Nasal congestion; Pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500035P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219253	04/19/2004	NY	15.0			F	03/16/2004	Tongue Discoloration; Accidental Overdose; Medication error/ Drug mal-administration. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a health professional regarding a 15 year old female patient who experienced tongue discoloration after receiving a second dose of Flumist on 17-Feb-2004. On 17-Feb-2004 the patient received a second dose of Flumist (accidental overdose/medication error). The first dose of vaccine was given on 05-Jan-2004. The doctor's office misread the flyer that accompanied the Flumist and administered the second dose since the patient had not been given a flu shot in the past. Immediately after administration of the second dose, the patient's tongue turned pink/tongue discoloration. See related cases HQWYE568304MAR04 AND HQWYE666309MAR04 BOTH (ADVERSE EVENT, NON-EXPEDITED). No additional information was available at the time of this report. Follow Up: The reporter disclosed that a supply of lollipops of various colors, including the color of the patient's reported tongue discoloration, was availabe inteh room where the patient waited after immediately receiving the vaccine.									U	02/17/2004	02/17/2004	0	UNK	OTH	OTH	NONE	NONE	UNK		HQWYE666209MAR04	1						1	Medication error; Tongue discolouration	FLUN3~MEDIMMUNE VACCINES, INC.~500042P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219254	04/19/2004	NY	12.0			M	03/16/2004	Tongue discoloration; Accidental overdose (therapeutic agent); Medication error/ Drug mal-administration. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a 12 year old male patient who experienced tongue discoloration after he received a second dose of Flumist on 17-Feb-2004. The pt received the first dose of vaccine on 05-Jan-2004. On 17-Feb-2004 the patient received a second dose of Flumist (accidental overdose/medication error). The first dose of vaccine was given on 05-Jan-2004. The doctor's office misread the flyer that accompanied the Flumist and administered the second dose since the patient had not been given a flu shot in the past. Immediately after administration of the second dose, the patient's tongue turned blue (tongue discoloration). No additional information was available at the time of this report. See related cases HQWYE568304MAR04 and HQWYE666209MAR04 both (adverse even, non-expedited). Follow Up: The reporter disclosed that a supply of lollipops of various colors, including the color of the patient's reported tongue discoloration, was available in the room where the patient waited after immediately receiving the vaccine.									U	02/17/2004	02/17/2004	0	UNK	OTH	OTH	NONE	NONE	UNK		HQWYE666309MAR04	1						1	Accidental overdose; Medication error; Tongue discolouration	FLUN3~MEDIMMUNE VACCINES, INC.~500042P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219255	04/19/2004	NY	36.0	36		F	01/02/2004	Pyrexia/Fever; Rhinorrhea/Runny Nose; Cough/Dry cough; Rigors/chills; Pain/Generalized Aching. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 36 year old female patient who experienced runny nose, dry cough, chils, body aches and fever. At 36 years of age, th patient received a dose on 12-Dec-2003/ The patient experienced runny nose (rhinorrhea), dry cough/cough, chills/rigors and body aches/pain on 13-Dec-2003. On 17-Dec-2003, she developed a fever (pyrexia) of 100.7 deg F. No additional information was available at the time of this report.									N	12/12/2003	12/17/2003	5	UNK	PVT	PVT	NONE	NONE	UNK		HQWYE772419DEC03	1						1	Chills; Cough; Pain; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219256	04/19/2004	NJ	20.0	20		F	01/14/2004	Orbital Oedema; Pyrexia/Fever. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a 20 year old female patient who experienced peri-orbital edema and fever. At 20 years of age, the patient received a dose on 10-Dec-2003. The patient experienced peri-orbitla edema on 12-Dec-2003. Treatment included zyrtec (certirizine hydrochloriede) but this did not help. On 17-Dec-2003, the patient developed a low grade fever/pyrexia. No additional information was available at the time of this report.									U	12/10/2003	12/12/2003	2	UNK	OTH	OTH	UNK	UNK	UNK		HQWYE773616DEC03	1						1	Periorbital oedema; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219257	04/19/2004					M	01/19/2004	VACCINE EXPOSURE DURING PREGNANCY; SNEEZING; PYREXIA; HEADACHE; PHARYNGOLARYNGEAL PAIN; SORE THROAT. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a female patient who experienced sneezing, fever, headache, sore throat and vaccine exposure during pregnancy. The patient received a dose on 13-Dec-2003. On 13-Dec-2003, a pregnant female patient received Flumist 2003-4 formula (vaccine exposure during pregnancy) and developed fever (pyrexia), sneezing, headache and sore throat  (pharyngolaryngeal pain). As of 17-Dec-2003, her symptoms were improving. The outcome of the pregnancy is unknown. No additional information was available at the time of this report.									U	12/13/2003	12/13/2003	0	UNK	OTH	OTH	UNK	UNK	Pregnancy		HQWYE774519DEC03	1						1	Headache; Pharyngolaryngeal pain; Pyrexia; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219258	04/19/2004	PA	45.0	45		F	01/02/2004	RIGORS/CHILLS; VOMITING; PAIN/GENERALIZED ACHING. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a 45 year old female who experienced chills, vomiting and body aches, approximately 2.5 hours after administration. At 45 years of age, the patient received a dose on 17-Dec-2003. On 17-Dec-2003, approximately 2.5 hrs after Flumist administrtion, the patient experienced chills, vomiting and body aches. All symptoms were resolved at the time of this report. No additional information was available at the time of this report.									N	12/17/2003	12/17/2003	0	UNNK	PVT	PVT	NONE	NONE	UNK		HQWYE775019DEC03	1						1	Chills; Pain; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219259	04/19/2004	IN	7.0	7		F	01/02/2004	Ear infection; Pyrexia/Fever; Pharyngolaryngeal Pain/ Sore throat. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from the father of a 7 year old female who experienced fever 103 deg F, sore throat and ear infection. At 7 years of age, the child received a dose on 09-Dec-2003. The child experienced fever 103 deg F/ pyrexia and sore throat/ pharyngolaryngeal pain on 12-Dec-2003. On 13-Dec-2003, the child was diagnosed with an ear infection. The child was treated with Lorabid (loracarbef). As of 18-Dec-2003, the fever had resolved and the child was better. The reporter declined to provide additional information and declined to grant permission for follow-up investigation.									U	12/09/2003	12/13/2003	4	UNK	OTH	PVT	NONE	NONE	UNK		HQWYE785019DEC03	1						1	Otitis media; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219260	04/19/2004	NJ	10.0	10		F	01/02/2004	Pain/Generalized Aching, Rhinorrhea/Runny Nose; Pharyngolaryngeal pain/ Sore throat. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a mother of a 10 year old female who experienced runny nose, sore throat and aches. At 10 years of age, the patient received a dose on 13-Dec-2003. The patient experienced runny nose (rhinorrhea), sore throat (pharyngolaryngeal pain) and aches (pain) on 16-Dec-2003. No additional information was available at the time of this report.									U	12/13/2003	12/16/2003	3	UNK	PVT	OTH	UNK	UNK	UNK		HQWYE786119DEC03	1						1	Pain; Pharyngolaryngeal pain; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219261	04/19/2004	NJ	35.0	35		F	01/02/2004	Rhinorrhea/ Runny Nose; Pain/ Generalized Aching. Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (forzen)) was received from a consumer regarding a 35 year old female patient who experienced runny nose and became achy. At 35 years of age, the patient received a dose on 13-Dec-2003. The patient experienced runny nose (rhinorrhea) on 13-Dec-2003 and became achy (pain) on 16-Dec-2003. No additional information was available at the time of this report.									U	12/13/2003	12/13/2003	0	UNK	PVT	OTH	NONE	UNK	UNK		HQWYE787919DEC03	1						1	Pain; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219262	04/19/2004	NY	7.0			M	03/16/2004	Rhinorrhea/Runny Nose; Unevaluable event. Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (forzen)) was received from a father regarding his 7 year old son who developed a runny nose and felt run down. The patient received the first dose on an unspecified date. The father reported that within 3 days of receiving Flumist (2003-4 Formula), his son developed a runny nose and felt run down. The events lasted several days. The patient's nine year old brother experienced a similar reaction (see MCN: HQWYE812504FEB04). No additional information was available at the time of this report									U				UNK	OTH	PVT	UNK	UNK	UNK	~Influenza (Seasonal) (FluMist)~~9.00~In Sibling|~Influenza (Seasonal) (FluMist)~~0.00~In Sibling	HQWYE812104FEB04	1						1	Fatigue; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219263	04/19/2004	NY	9.0			M	03/16/2004	Rhinorrhea/ Runny Nose; Unevaluable event. Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (forzen)) was received from a father regarding his 9 year old son who developed a runny nose and felt run down . The patient received the first dose on an unspecified date. The patient's 7 year old brother experienced a similar reaction (see MCN: HQWYE812104FEB04). No additional information was available at the time of this report.									U				UNK	OTH	PVT	UNK	UNK	UNK	~Influenza (Seasonal) (FluMist)~~7.00~In Sibling|~Influenza (Seasonal) (FluMist)~~0.00~In Sibling	HQWYE812504FEB04	1						1	Fatigue; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219264	04/19/2004	WI	6.0	6		F	02/12/2004	Medication error/ Drug maladministration; Dysgeusia/Bad taste. Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (forzen)) was received from a healthcare professional regarding a 6 year old female. On 05-Feb-2004 during vaccine administration, part of the Flumist dose was accidentally sprayed onto the patient's cheek and possibly into her eye. The patient experienced a bad taste in her throat. On 05-Feb-2004 during the administration of Flumist, the patient  reared back because of a bad taste/ Dysgeusia in her throat. Part of the dose was accidentally sprayed onto patient's cheek and possibly into her eye/ medication error. The patient's eye (reporter did not specify which eye) was flushed with water and no eye irritation was observed. No additional information was available at the time of this report.									U	02/05/2004	02/05/2004	0	UNK	OTH	PVT	NONE	NONE	UNK		HQWYE858206FEB04	1						1	Dysgeusia; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219265	04/19/2004	NC	11.0			F	01/19/2004	Influenza. Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (forzen)) was received from a healthcare professional regarding an 11 year old female patient who received a dose on December 12, 2003 and subsequently developed influenza.									Y	12/12/2003	12/16/2003	4	Culture 12/16/2003: nasal swab positive for influenza	OTH	OTH	NONE	UNK	UNK		HQWYE994231DEC03	1						1	Drug ineffective; Viral infection	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0219266	04/19/2004	NJ	5.0			M	01/21/2004	Pyrexia. Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a parent regarding his 5 year old son who received a dose in Dec 2003 and developed fever. The child's father reported that his son received a dose of Flumist (2003-4) in Dec-2003, and two days later, developed a fever (pyrexia) which has been up and down and as high as 102 degrees F. The child was seen by the physician but according to the father, his son did not have a fever that day. No additional information was available at the time of this report.				Y					U				UNK	PVT	PVT	UNK	NONE	UNK		HQWYE995431DEC03	1						1	Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0219286	04/20/2004	WA	39.0	39		F		JOINT PAIN-ALL JOINTS (ALTHRALGIA, ARTHRALGIA). JOINT STIFFNESS/JOINT DISORDER. PAIN AT SITE OF INJECTION. SWELLING AT SITE OF INJECTION. INJECTION SITE EDEMA. A report was received from a health care professional on 28 October 2003 concerning a 39 year old female vaccinee who experienced pain and swelling at the site of injection on the same day of receiving Fluvirin and pain in all of her joints and joint stiffness 2 days after receiving Fluvirin on 23 October 2003. On 23 October 2003, the vaccinee experienced pain and swelling at the site of inject on which continued until the next day. On 25 October 2003, the vaccinee experienced pain in all her joints (including her toes), and joint stiffness. The reporter indicated that the vaccinee has received influenza vaccines annually for the past 11 years and has not experienced this type of adverse reaction. At the time of reporting the vaccines had not recovered. The vaccinee plans to be evaluated by her physician. There was insufficient information to determine the reporter's causality assessment. Update 1, 09 January 2004: Futher information was received from a health care professsional indicating that the vaccinee experienced joint pain ina ll her joints on 24 October 2003 after receiving Flurin on 22 October 2003. The joint pain made it difficult for the vaccinee to move. The vaccinee had no relief despite treatment with ibuprofen following one week without improvement and off work the vaccinee consulted her physician who prescribed 40 mg daily of prednisone for 5 days. The vaccinee started to improve within 2 days. However, two weeks later the vaccinee still had some joint pain in her arms, shoulders and hands. The vaccinee recovered in an unspecified date The reporter has asssesed the relationship of the vaccine to the joint pain as probable. Update 2, 07 April 2001: Following medical review this case was upgraded to serious in view of the nature and persistence of the joint pain and stiffness, the lack of response to NSAID and the requirement for prednisoe. Follow up pending.  Follow up on 07/19/04 states: The reporter confirms that the joint pain and stiffness started on 10/23/03 and had resolved by 12/01/03. The vaccinee had consulted her physician, has stayed off work for one week and had taken corticosteroids to decrease the pain. She had received influenza vaccines previously, but had not experienced any problems before. The reporter considers the events probably related to Fluvirin. No further information is expected.									U	10/22/2003	10/24/2003	2		UNK	UNK					PJP200300920	1						1	Arthralgia; Arthropathy; Injection site oedema; Injection site pain; Injection site swelling; Joint stiffness	FLU3~EVANS VACCINES~765753~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0219336	04/21/2004	NC	78.0	77		F	10/10/2003	Pt received Flu vaccine on 10-8-03- Pt noticed knot and bruise on 10-10-03. Pt returned to health department on 11-10-03, bruise measured 1 1/2 inch long by 1 1/2 inch wide, hematoma 1 inch long by 1 inch wide.				Y					U	10/08/2003	10/10/2003	2	NONE	PUB	PVT	Lasix, Cartiaxt, Potasa, coumaslin, Aspirin, Protonix, Caltrate, Xanax, Lipitor, Synthroid, Fosame.	NONE	Allergy to Codeine.		NC03135	1						1	Contusion; Haematoma; Skin nodule	FLU3~SANOFI PASTEUR~U12878A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0219422	04/23/2004	CA	60.0	59		F	04/19/2004	1/20/04 Complained of shooting pains down right arm, numbness, tingling right fingers x 3 weeks. Tx for RT myositis/bicep tendonitis results not back from MRI (some heat).									U	01/05/2004	01/05/2004	0	MRI right shoulder	PVT	PUB	Diovan, Vanceri Premarin, Isosorbide/Albuterol, Lipitor, Aveora, Furosemide, Orynaz.	CAD, Hypothyroidism, COPD, Increased Lipids	Codeine/Estradiol			1						1	Hypoaesthesia; Myositis; Pain; Paraesthesia; Tendonitis	FLU3~SANOFI PASTEUR~U1293AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0219424	04/23/2004	MD	52.0	52		M		Tinnitus 14-16 hours post vaccines bilaterally.									N	03/25/2004	03/26/2004	1	NONE	MIL	MIL	Zocn 10mg, Glucosamine 500	NONE	Hypercholesterolemia			1						1	Tinnitus	ANTH~EMERGENT BIOSOLUTIONS~~UNK~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4020071~2~~~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0219583	04/28/2004	TX	49.0	49		F	04/20/2004	Awoke in morning with both hands (especially right) swollen. Was seen at local clinic, had x ray and blood work for rheumatoid arthritis. Hx of Hodgekins disease 1975, Breast Cancer 2001; hepatitis as child (probab. Hep A). Symptoms requ. MD and was observed for six weeks or more.				Y					N	11/13/2003	12/01/2004	384	X-ray of hands, blood test for rheumatoid arthritis- both negative	PUB	UNK	Synthroid, Flovent inhaler, Prenedine creme	NONE	Hay fever, Seasonal allergies and defects, Medical Conditions as listed in box 7.			1						1	Oedema peripheral	FLU3~SANOFI PASTEUR~U1092AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0199945	04/29/2004	PA	0.75	0	.8	M	06/04/2003	Additional information received on 5/29/03 provided lab test results. Information has been received from a pediatrician regarding an 11 month old with a history of otitis media and an ENT surgery in 10/02. On 12/23/02, at 9 months of age, he received his third dose of Prevnar. The physician indicated that the infant received hepatitis B vaccine and Fluzone on an unspecified date. The pediatrician reported that he developed pneumococcal sepsis on an unspecified date and died on 3/6/03. Lab test results revealed a positive bacterial culture for S. pneumoniae serotype 35E.	Y	03/06/2003							N	12/23/2002	03/06/2003	73	Pneumococcal sepsis; no autopsy results received yet.	PVT	PVT	UNK	NONE	Otitis media; Surgery		HQWYE121518MAR03	1						2	Bacterial infection; Sepsis	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~2|PNC~PFIZER\WYETH~~3~IM~~PNEUMO (PREVNAR)~2	USA	Results in Death	Influenza
0219749	04/30/2004	WA	74.0	74		M	04/27/2004	Tuesday 11/4/03 Received flu shot about 2:00 Pm. Thursday 11/6/03 7:00 PM started getting extreme rapid heart beat. After a couple hours, heart rate went lower but was still rapid. Friday 11/7/03 Heart rate was still rapid but felt like it dropped considerably. Felt a little warm so started taking Tylenol. That made me feel better so I felt like was beating it so I did not call doctor Friday. I was wrong; my throat started hurting Friday night. Saturday 11/8/03 throat was worse and could not stop coughing. Saturday morning, had temp of 100. Saturday night had temp of 101. Called clinic consulting nurse at 9:20 PM. She said if temp got over 101 to go to the emergency room at hospital. Did not go to emergency room and seen doctor first thing Monday morning 11/10/03. Monday 11/10/03 AM When I arrived at doctor's office, I had extreme rapid heart beat. At one point, they said my rate was 165. They sent me immediately by ambulance to Emergency room at hospital to get my heart rate down. They wouldn't even let my wife ride in ambulance with me. Took 3 hours to get heart rate down. They released me to go home. After a couple days my heart was back on track. Had slight temperatures on and off and it took four weeks for coughing to stop. I was coughing so hard and it felt like a lot of the time it was coming from center of my stomach so stomach hurt for several days. If you need further information from my medical records, I will approve for release to you. I was in good health on 11/4/03 when I received flu shot. Of course, we don't know if it was the flu shot that created the extreme rapid heart beat, sore throat, high temperature and so much coughing. I have never had this type of flu before with extreme rapid heart beat. Right now I have mixed feelings about ever taking another flu shot. I will be meeting with my doctor in August and discuss the upcoming flu season and flu shot. I would not want anyone to get this particular flu that I had. And as I said above, any medical information you want from my records I will approve for release. Nurse follow up on 05/25/04: atrial fib, viral syndrome.			Y	Y					Y	11/04/2003	11/06/2003	2	EKG abnormal	OTH	OTH	NONE	NONE	sinus tachy;			1						1	Abdominal pain upper; Atrial fibrillation; Cough; Electrocardiogram abnormal; Heart rate increased; Pharyngolaryngeal pain; Pyrexia; Viral infection	FLU3~EVANS VACCINES~066521~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening	Influenza
0219750	04/30/2004	NC	55.0	55		M	04/26/2004	Severe chest, shoulder, arms, throat and jaw pain, shortness of breath, occurs every 7 to 8 hours for 2 months. Relieved only by pain pills. After 2 months, shortness of breath, lightness in chest and pain in both jaws. Relieved by pain pills after a 4 day stay in the hospital. Doctor has me on nitro patches. Still have shortness of breath and tightness in chest. Doctor said it was angina pectoris htn. Never had this problem before I got flu shot. Per annual report-has severe breathing problems and cannot work because of it.  He has been out of work for over a year and it looks like he will not be returning to work.  He has not received any compensation because of this.  Since receiving the flu shot  health has been going downhill ever since.			Y	Y	Y	4			N	10/03/2003	10/03/2003	0	Angina pectoris htn; Stress test Discharge summary from Discharge summary states abnormal lab test. msv	MIL	MIL		NONE	Morphine Discharge summary states allergy, anemia, hyperlipedemia, drug dependance. msv			1						1	Angina pectoris; Chest discomfort; Chest pain; Dyspnoea; Laboratory test abnormal; Pain in jaw; Shoulder pain	FLU3~SANOFI PASTEUR~U1089AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0219778	04/30/2004	IN	37.0	37		F	04/23/2004	Became pregnant approx 2nd week of Feb 2004, About 2 weeks after receiving LAIV. On 04/16/04 in the afternoon began spotting. 04/15/04 HCG blood draw done. 04/18/04 HCG blood draw done. Count dropped by 1/2. Emergency D&C done on 04/20/04 for hemmoraging. To return for next Or. visit during week of 04/26/04. This was 5th pregnancy. Has no previous history of miscarriages.				Y					Y	01/28/2004	04/15/2004	78	HCG labs done on 4/16/04 and 4/18/04	PUB	OTH		NONE	NONE			1						1	Abortion spontaneous; Antepartum haemorrhage; Metrorrhagia	FLUN3~MEDIMMUNE VACCINES, INC.~500089P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0219811	05/03/2004	PA	12.0			F	12/10/2003	Client left clinic area, while in parking lot fainted/shaking and became incontinent of urine, via ambulance to hospital.				Y					Y	12/04/2003	12/04/2003	0	UNK	PUB	PUB	NONE	NONE	Sulfa; PCN;		PA0404	1						1	Syncope; Tremor; Urinary incontinence	FLU3~SANOFI PASTEUR~U1148BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0219819	05/03/2004	WI	1.6	1	.4	F	04/20/2004	On evening of the day vaccine was given child developed fever of 102.  Next morning temperature was 101.7, also child had decreased activity level and was fussy.  Seen 03/10/04, was a little better, temperature 100.3, still somewhat fussy, crabby.									Y	03/08/2004	03/08/2004	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Fatigue; Irritability; Pyrexia	FLU3~SANOFI PASTEUR~U1144AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0219843	05/03/2004		49.0	49		F		A report was received from a health care professional on 2/9/04 concerning a female vaccinee of unspecified age who experienced ear pain within a few days of vaccination and neck pain, chills, headaches, post-nasal drip, muscle spasms, an increase in blood pressure, an increase in heart rate, fluid in her ear, sinus congestion, a sensation of her body being on fire, diarrhea, palpitations with shortness of breath, loss of appetite, hair loss, night sweats, pain in the right deltoid, pain in the right shoulder joint, numbness in the fingers, muscle cramps, fatigue, cough, tingling in the head and jaw and was unable to turn her head an unspecified length of time after receiving Fluvirin on the right side on 10/23/03.  On an unspecified date the vaccinee experienced right ear pain within a few days of vaccination and right-sided neck pain, chills, headaches which lasted approximately 1.5 weeks, severe post-nasal drip (on the right side only), muscle spasms in the jaw and neck, an increase in blood pressure, an increase in heart rate, fluid in her right ear, severe sinus congestion, a sensation of her body being on fire lasting for about 10 hours, diarrhea, palpitations with shortness of breath, loss of appetite, hair loss, night sweats, pain in the right deltoid, pain in the right shoulder joint, numbness in the fingers, muscle cramps in her right calf and thigh, fatigue, cough, a sensation of tingling in the head and jaw and was unable to turn her head. The reporter indicated that all symptoms began shortly after receiving Fluvirin. The vaccinee indicated that most of the symptoms had subsided but continues to have problems with sinus congestion, nasal discharge, fatigue, blocked ears, and muscle pain but not as significant as when experienced initially. The vaccinee also experienced some symptoms on the left side but were less intense. The vaccinee was unable to exercise when the symptoms were most intense. At the time of reporting she had commenced exercising again and noted that the muscles on the right side of her body were significantly more painful than the muscles on the left side. Laboratory tests including thyroid function and head CT were normal. It was suggested that the symptoms experienced by the vaccinee may be due to a reaction to the immunization or may be due to a type of flu virus. There was insufficient information to determine the reporter's causality. Update 1, 4/20/04: Further information was received from a health care professional who is also the 49 year old consumer who experienced neuropathies and paraesthesia after receiving Fluvirin. The vaccinee's symptoms were considered to be disabling. The vaccinee has undergone numerous tests. However, no diagnosis has been confirmed and she continues to experience neuropathies, paraesthesias and muscle spasms. The vaccinee has a medical history of normal childhood illnesses. The vaccinee was treated with gabapentin, cyclobenzaprine hydrochloride and physical and massage therapy. Follow up pending.								Y	U	10/23/2003				UNK	UNK	NONE		Normal childhood illnesses		PJP200400130	1						1	Alopecia; Anorexia; Blood pressure increased; Chills; Diarrhoea; Dyspnoea; Ear pain; Headache; Heart rate increased; Hypoaesthesia; Muscle spasms; Nasal congestion; Neck pain; Night sweats; Pain; Palpitations; Postnasal drip; Shoulder pain; Skin burning sensation	FLU3~EVANS VACCINES~765873~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0219856	05/04/2004	WA	15.0	15		M	12/04/2003	Rash/itching on back and arm at 5:15 (about 1 hour after administration)									U	12/04/2003	12/04/2003	0		OTH	PVT	NONE	NONE	NONE		WA042024	1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U1254AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0219944	05/05/2004	NY	34.0	33		F	02/08/2004	See attached clinical summary. Reports being in good health with no prior adverse reactions to any previous immunization until November 2, 2002. She received 3 immunizations and a PPD (Hepatitis A #2, Influenza and Td) the morning of November 2nd, without apparent incident. States that approximately 30 minutes later recalls, a tingling feeling, a slight itchy in the throat and feeling tired, so went to lie down. Later that afternoon, @2:30PM noted itchiness on arms and neck followed by a generalized rash with hives and welts on the neck arms, chest and back. Also had swelling of the face and hands. Denies wheezing, fever, nausea or vomiting, but says tongue felt swollen and throat felt tight and felt woozy. Was seen in the clinic and immediately sent to the ER. Once there was given Benadryl 50mg IM, received IV fluids, O2, and observed until the symptoms began to subside. Was released on oral prednisone and given a referral to be evaluated by an Allergist. Subsequently under went skin testing that demonstrated positive reactions to trees, grass and weeds, but did not address vaccine allergies and or desensitization.				Y					Y	11/02/2002	11/02/2002	0	Skin testing: Subsequently under went skin testing that demonstrated positive reactions to trees, grass and weeds, but did not address vaccine allergies and or desensitization.	MIL	MIL	PPD, OCP's	NONE	Seasonal Allergies, Eczema			1						1	Dizziness; Fatigue; Hypersensitivity; Hypoxia; Oedema peripheral; Paraesthesia; Pruritus; Rash; Swelling; Swelling face; Throat tightness; Tongue oedema; Urticaria	FLU3~PFIZER\WYETH~4020032~2~IM~~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEPA~MERCK & CO. INC.~0701M~2~IM~~HEP A (VAQTA)~1|TD~SANOFI PASTEUR~UA525AA~UNK~IM~~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0220079	05/10/2004	CA	36.0	36		M	05/06/2004	Client had influenza vaccine 10/11/03. Rash reported 10/12/03 at 9AM. Client also on TMP/SMX since 10/2/03. D.C. TPM/smx, give benadryl 50mg IM Stat and 25mg p.o. qidx 2 days. Rash reported as scattered wheal like to both arms, buttocks, back, both thighs. Wheals raised, red uneven borders, various sizes. No rash 10/19/03.									Y	10/11/2003	10/12/2003	1	NONE	PVT	PUB	Multivitamin, Propranolol, lorantadine tolnaftate pwd, TMP/smx	Sinsusitis	Allergy-penicillin/ sinusitis, allergic rhinitis			1						1	Rash; Rash erythematous	FLU3~EVANS VACCINES~765140~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0220080	05/10/2004	CA	67.0	66		M	05/05/2004	Influenza Vaccine given 9/29/03. Client presents 10/6/03 with reddened purple non-tender nodules. .25-1.0 cm areas on palms and dorsum of hands and back. Client indicates it started 1 week prior. Physician indicates probable erythem nodosum to flu vaccine. Gave Methylpred 60mg IM X1. Triamcinolone topical. Rash faded 10/14/03.									Y	09/29/2003	10/06/2003	7	NONE	PVT	UNK	Atorvastatin 10mg	NONE	Dyslipidemia, PPD+			1						1	Erythema; Rash; Skin discolouration; Skin nodule	FLU3~EVANS VACCINES~765140~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0217865	05/12/2004	MN		52		F	04/28/2004	11/29/00 Flu shot approximately 2:00 PM. Pain started in upper left arm 2:20 PM. 11/30/00 OBGYN appointment. Blood pressure up - within normal range but higher than usual for me. Pain in upper left arm continued. 12/7/00 Pain had increased, blood pressure close to high level. 1/23/01 Blood pressure very high, pain extremely high and went from left shoulder to finger tips. No grip strength in left hand. X-rays and blood tests for muscle diseases normal. 1/30/01 Pain unbearable, now into shoulder. Unable to sleep. unable to type with left hand due to pain. Blood pressure dangerously high. 2/1/01 Started on Vicodin pain pills. EMG normal. 2/14/01 through 4/2/01 Treatment at rehab clinic. Ultrasound, electronic stimulation, and message therapy. Arm was better but would have pain off and on. Arm was weak. Blood pressure never came back down to rate before flu shot. 6/29/03 Arm started to hurt and pain just kept increasing. 6/30/03 Tendonitis in lower left arm. Given generic Vicodin. Got sick from pain pills. Stopped taking. Told to use moist heat. Pain continued to increase. 7/7/03 Tendonitis in lower left arm caused by muscle damage in upper left arm from flu vaccine. Use ice. Do stretching exercises. Pain in muscle upper left arm continues off and on. Tendonitis in lower left arm flares up regularly. Left arm is weak and not much grip strength in left hand.				Y				Y	N	11/29/2000	11/29/2000	0	1/23/01 X-rays, blood tests normal. 2/13/01 EMG normal.	OTH	OTH	NONE	NONE	Melanoma surgery 1996	Severe headache; Tunnel vision~Influenza (Seasonal) (no brand name)~~28.00~In Patient		1						2	Hemiparesis; Hypertension; Pain; Tendon disorder; Blood pressure increased; Muscular weakness; Pain; Sleep disorder; Tendonitis	FLU3~MEDEVA PHARMA, LTD.~E70200KA~3~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~E70200KA~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Disabling	Influenza
0220188	05/12/2004	CA	73.0	72		F	05/05/2004	From initial information received on 5/4/04 from the patient's daughter regarding an adverse event occurring in the USA, it was reported that a 73 year old female patient received a dose of FLUZONE, administered in the deltoid on the first week of December 2003. The lot number and route of administration were not reported. Two to three weeks later, the patient began tripping, which occurred three times, and developed short term memory loss. The patient resides overseas but was visiting USA at the end of November 2003. She returned overseas at the beginning of March 2004, and is currently hospitalized due to a brain infection. Reportedly, the patient was treated with Solu-Medrol. The patient's recovery status was not reported.				Y	Y				U	12/01/2003	12/15/2003	14	Culture not performed. MRI films of the brain showed two spots of the brain with infection.	UNK	UNK					200401811	1						1	Amnesia; Difficulty in walking; Infection	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0220198	05/12/2004					U		When nursing personnel in a university hosp. on a general medicine floor were administering the Fluviron (Influenza Vaccine 2003-2004, Evans, lot 765880, exp june, 30,2004) influenza vaccine they mistakenly identified the 0.25ml line that is on the vile as the line that they were supposed to expel to for adult patients.									U					UNK	UNK						1						1	Medication error	FLU3~EVANS VACCINES~765880~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0220289	05/13/2004	GA	33.0	32		F	05/13/2004	Patient received anthrax and influenza vaccines on the same day with mild local reactions. Her LMP prior to conception was in October 1998. She became pregnant approximately 1 month after receipt of the vaccines (Estimated date of conception was between 12 and 15 November).  Pregnancy was diagnosed around November 20th.  Her due date was 8/15/99.  She delivered a baby boy on 8/8/99. Her son, who is now 4, was just diagnosed with high level functioning autism. (A separate VAERS report will be filed on him, listing his vaccine history and onset of symptoms.)									Y	10/13/1998	11/13/1998	31	None.	MIL	MIL	PRN OTC cold and sinus medications	None on day of vaccine. Was having allergy symptoms intermittently and had occasional sinus symptoms at various times during that year.	None.			1						1	Autism; Foetal disorder; Medication error; Unintended pregnancy	ANTH~EMERGENT BIOSOLUTIONS~FAV017~3~SC~UN~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~097017U~4~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0220334	05/13/2004	UT	26.0	25		F	05/13/2004	It was the determination of the physician that member received a vaccine other than IPPD intradermally.  Member had redness and discomfort on the affected arm.  Member was retested with IPPD placed on right arm without adverse reaction.									Y	04/03/2004	04/04/2004	1	Member received medical attention and follow up care from physicians.	MIL	MIL	Flonase, Atarax, Demulin	none known	none known			1						1	Discomfort; Erythema	FLU3~EVANS VACCINES~765756~5~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0220298	05/14/2004	MI	53.0	53		F	05/10/2004	Transverse myelitis. Paraparesis left side greater than right. Sensory level of T10. Medical records state abnormal vision. msv				Y	Y	2			N	11/24/2003	11/24/2003	0	Medical records state urinary tract infection. msv	PVT	UNK	Allergy shots; Allegra	NONE	Allergies; Myasthenia gravis			1						1	Myelitis transverse; Paresis; Urinary tract infection; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0220299	05/14/2004	MA	37.0	37		M	04/26/2004	37 yo male patient presented with complaint of lump on back of right upper arm after anthrax vaccine (dose #6). Pt states that he never had a reaction like this with any other dose of anthrax vaccine.									U	04/23/2004	04/24/2004	1		MIL	MIL						1						1	Injection site mass	ANTH~EMERGENT BIOSOLUTIONS~FAV082~6~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~EVANS VACCINES~765756~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TYP~SANOFI PASTEUR~W09092~3~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0220300	05/14/2004	MI	55.0	55		F	03/22/2004	3-22-04 4:45P Pt stated immediately after receiving the influenza vaccine in her left arm she has had constant pain. Denies any redness or swelling at that time. Pt stated left arm became progressively worse with movement and pain continued. On 3-19-04 pt saw internal medicine physician. The diagnosis was possible nerve damage. Pt referred to neurologist and EMG is scheduled on 3-29-04 at 10:00A. Client stated at this time she is unable to raise left arm for certain everyday tasks. She cannot shampoo hair, fasten seat belts, pull up nylons, and shut her car door with her left arm. Pain rated (9 1/2) on a scale of 0 to 10. She stated her pain is from left elbow to left shoulder. 4/19/04 TC received from client stating MRI of Left shoulder completed 04/09/04 showing normal aging but no cervical spine problems. Stated she was referred to a physical therapist who believes the frozen shoulder she now has may be due to a inflammatory process that may have directly resulted from the flu shot injuring a nerve She had no prior injury to the arm prior to the Flu shot and he highly suspects this has caused the symptoms. She will continue with PT.				Y					U	12/08/2003	12/08/2003	0	EMG 3-29-04, results inconclusive  Sched. for MRI 4/9/04	PUB	UNK		NONE	NONE		M12004036	1						1	Hypokinesia; Nerve injury; Pain; Shoulder pain	FLU3~SANOFI PASTEUR~U1122AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0220317	05/14/2004	TX	27.0	27		M	05/12/2004	05/8/04: Pt developed highly pruritic vesicular lesions. Pt is afebrile. 05/10/04: Pt placed in isolation-symptomatic tx. 05/12/04: some vesicles beginning to scale.  Nurse follow up on 07/28/04 states: Complete.				Y	Y				U	04/19/2004	05/08/2004	19		MIL	MIL	NONE	NONE	NONE			1						1	Blister; Pruritus; Skin ulcer	ANTH~EMERGENT BIOSOLUTIONS~FAV082~2~~RA~ANTHRAX (BIOTHRAX)~1|DT~UNKNOWN MANUFACTURER~U0828AA~UNK~~RA~DT ADSORBED (NO BRAND NAME)~1|FLU3~EVANS VACCINES~765757~2~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~SMITHKLINE BEECHAM~5582C6~2~~RA~HEP B (ENGERIX-B)~1|HEPA~SMITHKLINE BEECHAM~776C6~2~~RA~HEP A (HAVRIX)~1|SMALL~PFIZER\WYETH~4030013~1~~LA~SMALLPOX (DRYVAX)~1	USA	Hospitalisation	Influenza
0220390	05/17/2004		54.0	54		F		A report was received from a consumer on 05/04/04 who is a 54 year old female vaccinee who experienced influenza, which was considered disabling, approximately 2 weeks after receiving Fluvirin and Pneumonia vaccine (unspecified) on 10/20/03 into seperate arms. The vaccine also experienced pneumonia, which was considered disabling an unspecified length of time after receiving Fluvirin and an unspecified pneumonia vaccine on 10/20/03.  The vaccine had received influenza vaccine for several years without any issues.  On 11/03/03 the vaccinee experienced a sore raspy throat and felt unwell after receiving Fluvirin and a pneumococcal vaccine on 10/20/03 in different arms.  The vaccinee's sore throat became extremely painful and she visited the ER on  11/09/03.  A throat culture was taken, which concluded that the vaccinee did not have a streptococcal throat.  The vaccinee was subsequently diagnosed as having the flu and was prescribed Levofloxacin and an unspecified cough medication with codeine to help with the painful sore throat.  On 11/1/03, the vaccinee had a follow up appointment with her treating physician as she had developed severe chest congestion.  The vaccinee received an unspecified steroid injection at the clinic and was prescribed a course of Prednisone therapy.  On 11/19/03, the vaccinee returned to her treating physician's office and complained of severe head congestion and was subsequently prescribed amoxicillin and albuterol. The vaccinee developed diarrhea from the amoxicillin. Throughout this period of time the vaccinee was unable to work. The vaccinee visited the physician's office again on 12/15/03 and between this appointment and the last visit she reported that her lungs felt like they were on fire.  the physician stated that her lungs sounded clear and prescribed montelukast sodium and stated that she was to continue albuterol therapy.  On 01/15/03, the vaccinee saw a lung specialist and had an X-ray which confirmed that her lungs were clear, however there was evidence of residual scarring that may have occurred cue to the pneumonia. The vaccinee returned to work on 02/16/04, however she continued to experience fatigue.  Due to her continued fatigue she quit her job on 03/08/04.  On 03/24/04, the vaccinee visited her physician due to bouts of wheezing and returning symptoms of a sore throat.  The vaccinee was presribed albuterol and another course of amoxicillin.  On 04/05/04, the vaccinee returned to her physician with continued symptoms and was prescribed a course of azithromycin that relieved her symptoms.  At the time of the report the vaccinee continued to experience periods of wheezing and shortness of breath. The vaccinee is unsure if she just contracted flu or pneumonia, as anyone in contact with her has not contracted any illness from her.  However, this was her first exposure to the pneumonia vaccine. Follow up received 31Aug04 from a healthcare professional. The vaccinee was confirmed as a 54 year old female (height 5ft 4 inches; weight 161 pounds). The vaccinees medical history included allergies to Tetracycline, Doxycycline, Zyrtec, Celexa and Bellergal. Cardiac catheter in 1997, total abdominal hysterectomy in 1993 and anxiety disorder and mitral valve prolapse. Her concomitant medications included Buspar 15mg twice daily for depression; Ambien 5mg at bedtime for sleep disorder; Zovirax 20mg Prn, caltrate 600mg, Depakote 500mg twice daily for mental disorder; Nexium 20mg for influenza vaccine on 15Oct02.  On 20Oct03, the vaccinee received 0.5ml Fluvirin IM. Ten day later (on 09Nov03) the vaccinee was seen in the ER for sore throat, purulent drainage and cough, fever and hoarseness. She was diagnosed with acute bronchitis and tonsilitis. She was seen in follow up by her physician on 12Nov03, 19Nov03 and 15Dec03. The outcome was not reported. The reporter commented that none of the events were due to vaccination. The reporter does not indicate that these events were serious. A report was submitted to the authorities on 07Apr04 by the healthcare professional.								Y	U	10/20/2003	11/03/2003	14	Chest x-ray (01/15/04): unk; Throat culture (11/09/03): unk;	OTH	OTH	NONE	NONE	Received influenza vaccine for several years without any issues. Allergies: Tetracycline, Doxycyline, Zyrtec, Celexa, Bellergal. Anxiety disorder, Mitral valve prolapse. 1993-Total abdominal hysterectomy; 1997 Cardiac catheter.		PJP200400203	1						1	Dyspnoea; Fatigue; Lung disorder; Nasal congestion; Pharyngolaryngeal pain; Pneumonia; Wheezing	FLU3~EVANS VACCINES~795180~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0218400	05/18/2004	IN	54.0	54		F	05/13/2004	Information has been received from a 54 year old female consumer with an anxiety disorder and a history of cataract surgery and foot surgery who on 10/20/03 was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot # 647039/0604N).  Concomitant therapy that day included influenza virus vaccine (unspecified). Other concomitant therapy included buspirone HC1 (Buspar), zolpidem tartrate (Ambien), divalproex sodium (Depakote), esomeprazole magnesium (Nexium), and alprazolam (Xanax). The pt noted that she was in perfect health at the time of vaccination. Subsequently, approximately ten days later, the pt became sick.  Initially, she had a sore throat. Then the pt had congestion in her lungs, followed by problems breathing, wheezing, running nose, and ear infections.  It was reported that to date, her condition (was) somewhat better, however she continued to suffer from wheezing, congestion, breathing problems and she became fatigued more easily. She said that she had been treated with unspecified antibiotics, steroids, and inhalers.  It was noted that the pt had no history of allergic reactions. At the time of the report, the pt was recovering with sequelae.  Follow up information received from a RN in the pt's doctor's office reported that this pt was the only one who has had any complaints after vaccinations.  The office reportedly gave >400 flu vaccines but don't know how many (pneumococcal 23v polysaccharide vaccine) vaccinations.  It was reported that no one else has had any problems or complaints.  While consumer considered sickness of sore throat, congestion in her lungs, problems breathing, wheezing, running nose, ear infections, and fatigue to be disabling. Additional information has been requested. The pt reported previously contacting the CDC and VAERS and was reportedly given VAERS ID 218400. Follow up on 05/25/04 states: Addittional follow up information included the lot # and manufacturer of the influenza virus vaccine. The consumer considered sickness of sore throat, congestion in her lungs, problems breathing, wheezing, runnning nose, ear infections and fatigue to be disabling. Additional information has been requested. The pt reported previously contacting the CDC and VAERS and was reportedly given VID 218400.				Y				Y	U	10/20/2003	10/30/2003	10	UNK	OTH	OTH	Xanax; Buspar; Depakote; Nexium; Ambien;		Cataract extraction; Foot operation; Anxiety disorder;		WAES0405USA00126	1						2	Asthma; Atrioventricular block; Blood pressure increased; Condition aggravated; Cough; Dyspnoea; Influenza like illness; Nasal congestion; Pharyngolaryngeal pain; Pulmonary congestion; Respiratory tract infection; Upper respiratory tract infection; Weight increased; Dyspnoea; Fatigue; Lung disorder; Malaise; Nasal congestion; Otitis media; Pharyngolaryngeal pain; Rhinorrhoea; Wheezing	FLU3~EVANS VACCINES~795180~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0604N~UNK~~~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0604N~UNK~~~PNEUMO (PNEUMOVAX)~2	USA	Disabling	Influenza
0220559	05/18/2004	PA	12.0	8		M	05/14/2004	Information has been received from a registered nurse concerning a 12 year old male student with cerebral palsy who on 18Nov1999, was vaccinated in the right arm with a first dose of varicella virus vaccine live. Concomitant medications included a second dose of influenza virus vaccine (FLUZONE). There was no known illness at the time of vaccination. There were no known adverse events following prior vaccinations. On 29Mar2003, the patient developed itchy blisters. There were approximately 50-80 erythematous lesions with blisters mainly on the patient's trunk, face and legs. Upon clinical observation at an office visit on 30Mar2003, a diagnosis of varicella was made with a total of 100-200 lesions. On 14Apr2003 the child was scabbed over and able to return to school and was reported as recovered. No further information is expected.				Y					Y	11/18/1999	03/29/2003	1227	body height measurement, 53.5 inches body weight measurement, 79 lbs	PVT	PVT			Cerebral palsy		WAES0304USA01178	1						1	Blister; Cerebral palsy; Pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~V0167AA~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~6317751032J~1~~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0220687	05/19/2004	GA	24.0	24		F	10/29/2003	Stiff neck, body aches, fever and chils, sweats and stiff arm: can't lift it, can barely move the arm, swelling in shot area and redness.									U	10/27/2003	10/28/2003	1	NONE	PVT	PUB	Oral contraceptives	NONE	NONE	fever, chils~Rabies (no brand name)~2~23.00~In Patient		1						1	Chills; Erythema; Hyperhidrosis; Injection site swelling; Joint range of motion decreased; Musculoskeletal stiffness; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1124AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0925N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0220696	05/19/2004	CA	1.0			M	05/04/2004	Less than 24 hours after vaccines: febrile seizure- generalized-1 minute. Coincidental otitis media.									Y				NONE	PVT	PVT	NONE	Otitis Media	Mild Atopy			1						1	Febrile convulsion	DTAP~SMITHKLINE BEECHAM~122A2~4~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1078AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0830~3~IM~LA~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0178N~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0073N~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0221267	05/20/2004	TX	0.51	0	.5	M	05/20/2004	Vaccine administered 11-12-03, hospitalized      11-19-03 for difficulty breathing,weight loss, diagnosis of bronchiolitis and put on oxygen for two days.  Noticed first head tick/seizure 11-29-03. Office visit with the pediatrician and referred to neurologist who ordered EEG which gave diagnosis of seizures/partial complex seizures.  Put on Lamictal to control seizures, had to discontinue because of allergic reaction.  Admitted back to the hospital on 01-18-04 for further testing and put on phenobarbitol.  Admitted back to the hospital on 03-01-04 for more testing, EEG,CT scan.				Y	Y	13			N	11/12/2003	11/18/2003	6	5+ EEG's, 2 CT scans, MRI, blood work, UGI.	UNK	UNK	No	No	NO			1						1	Bronchiolitis; Convulsion; Dyspnoea; Hypersensitivity; Hypoxia; Tic; Weight decreased	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~C1624AA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1128AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~493475~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0212585	05/21/2004	CT	1.0	1	.1	F	05/14/2004	Information has been received from a physician concerning a 12 month old female pt who on 11/12/03 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included influenza virus vaccine (unspecified), which she was given because of her history of asthma. The physician noted that on the day of vaccination, the child had a cold (runny nose and cough but no other signs/symptoms). The pt had a history of asthma for which she had been on zobinex and unspecified steroids in the past; however, she had not received either medication within several months prior to vaccination with varicella virus vaccine live. The pt's mother indicated on 11/12/03, by the time they drove home from the MD's office, which was less than 1 hour after the vaccinations, the child was extremely ataxic.  Her balance was very off and she was constantly falling over like she was drunk. Prior to his, the child was able to balance/stand without difficulty. The severe ataxia persisted through 11/13/03, and as of 11/14/03 had slightly improved though not substantially. At the time of the report, the child remains at home and has not been hospitalized. The physician planned to continue to monitor the pt to see if the ataxia would resolve spontaneously. At the time of the report, she had no plans to do a lumbar puncture. The physician indicated that she believes the timing of the ataxia onset less than 1 hour post-vaccination with varicella virus vaccine live and/or the influenza virus vaccine.  The physician also reported that to her knowledge, the child did not have any exposure to varicella or other viruses prior to vaccination, nor did she had any history of trauma, specifically head trauma. Upon internal review, the pt's experience was considered an important medical event (OMIC). Additional information has been requested.				Y					N	11/12/2003	11/12/2003	0	NONE	OTH	OTH	UNK	Cold	Medical History: Asthma.		WAES0311USA01805	1						2	Coordination abnormal; Gait disturbance	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|VARCEL~MERCK & CO. INC.~~UNK~~~VARICELLA (VARIVAX)~2	USA	Emergency room visit	Influenza
0218919	05/21/2004	PA	77.0	76		M	05/20/2004	Per patient report day after receiving flu vaccine, became too weak to walk, fell and was vomiting. On 2/4/04 was admitted to hospital for 2 days.					Y	2			Y	02/03/2004	02/04/2004	1		MIL	PUB	Acetaminophen	NONE	Impotence; Moderate to severe hearing loss; Allergic rhinitis			1						2	Anxiety; Asthenia; Decreased appetite; Fall; Headache; Hypokalaemia; Malaise; Myalgia; Rash; Vomiting; Asthenia; Fall; Muscular weakness; Vomiting	FLUX~UNKNOWN MANUFACTURER~U1146BA~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0221301	05/21/2004		1.33	1	.4	M	05/14/2004	Information has been received from a registered pharmacist concerning a 16month old male who on 06Nov03 was vaccinated with varicella virus vaccine live and measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) , inadvertently via the IM route of administration instead of the recommended SC route. Concomitant therapy that day included influenza virus vaccine and respiratory syncytial virus vaccine. Subsequently, on 06Nov03, the pt developed a fever and increased heart rate. It was noted that the pt was not hospitalized. There was no product quality complaint involved. The pt sought unspecified medical attention. Additional information has been requested.				Y					U	11/06/2003	11/06/2003	0	UNK	OTH	OTH			UNK		WAES0311USA00676	1						1	Heart rate increased; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~IM~~MEASLES + MUMPS + RUBELLA (MMR II)~1|UNK~UNKNOWN MANUFACTURER~~UNK~~~VACCINE NOT SPECIFIED (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~~UNK~IM~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0221516	05/24/2004	GA	1.0	1	.0	F	05/14/2004	Information has been received from a LPN concerning a 12 month old white female with eczema and no known allergies or other medical history who on 10/22/03 at 10:30AM was vaccinated in the right arm with a first dose of varicella virus vaccine live (Lot # 645579/0440N). Concomitant therapy that day at 10:30AM included a first dose of MMRII (Lot # 641627/0666N) administered in the left thigh, a dose of Prevnar (Batch # 493266) administered in the left thigh, and a first dose of Fluzone (Batch # L11097AA) administered in the right thigh. On 10/29/03 the pt developed a rash with blisters on her legs, arms and abdomen. Some of the blistered were raised. The child was also noted to have a low grade fever. The outcome was reported as recovered. There were no relevant diagnostic tests or lab data. The reporter also reported another pt's adverse experience (WAES # 0311USA01477).  No further information is expected.				Y					Y	10/22/2003	10/29/2003	7	Body temp (10/29/03): Low grade fever;	PVT	PVT	NONE	NONE	Eczema;		WAES0312USA01388	1						1	Blister; Pyrexia; Rash; Rash maculo-papular	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0666N~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~~UNK~~~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0440N~UNK~~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0221580	05/24/2004	WA	1.2	1	.2	M	05/24/2004	Fever immediately. Rash 6 days later. Speech delay, head banging, mobility clumsyness, stomach problems, loose stool, butt rash, vomiting, chronic colds, ear aches. All, but the head banging which is in the past 6 months have taken place after the shot. Follow up: selective hearing, phonating, walking okay.				Y					N	09/04/2001	09/10/2001	6		PVT	PVT		NONE. Notes from doc. Active, alert baby appears normal, nose clear, normal. Ears, Normal All other signs normal	None	Fever~DTP (no brand name)~3~1.00~In Patient		1						1	Abnormal behaviour; Clumsiness; Diarrhoea; Ear pain; Gastrointestinal disorder; Pharyngitis; Pyrexia; Rash; Rhinitis; Vomiting	DTAP~UNKNOWN MANUFACTURER~507A2~4~~UN~DTAP (NO BRAND NAME)~1|DTP~UNKNOWN MANUFACTURER~~3~~UN~DTP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~5~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~4~~~HEP B (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~UA569AB~4~~~HIB (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~4~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~0378L~UNK~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0221812	05/25/2004		8.0			M	05/16/2004	My son received the Flumist vaccine. He became very nauseated immediately with complains of bad taste in mouth. He was weak that day. The next morning, he awoke vomiting, with a fever of 103.3, complains of severe headache, bronchitis, and extreme fatigue. I called the MD office where he received the vaccine, and they told me to watch him, and he should be better in a couple of days. On the 3rd day he was better. However, he began experiencing exercise induced asthma attacks in January 2003. He was diagnosed with bronchospasm 5/2004. He had not had any reactive airway prior to the vaccine. He also has had return of chronic otitis media since vaccine- has history of OM when he was younger.									U	12/11/2003	12/11/2003	0	5/3/2004 Spo2 86%, peak flow 200.	UNK	UNK			History of otitis media w/ pe tubes at 10 months, food intolerances, seasonal allergies.			1						1	Asthenia; Asthma; Bronchitis; Bronchospasm; Dysgeusia; Fatigue; Headache; Nausea; Otitis media; Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0221819	05/25/2004	PA	2.0	1	.0	M	05/14/2004	Information has been received from a health professional concerning a 25 month old white apparently healthy male with no known allergies and no medical history who on 1/6/03 was vaccinated SC in the right arm with a 0.5ml first dose of varicella virus vaccine live (lot # 638367/0198M). Concomitant vaccinations on 1/6/03 included a first dose SQ in the left arm of MMR (lot # 644234/0925M), a third dose IM in the left leg of hepatitis B virus vaccine  (+) HIB conjugate vaccine (lot # 643037/0652M) and a first dose IM in the right leg of influenza virus split virion 3v vaccine inactivated (lot U0941AA). There was no illness at the time of vaccination. On 2/5/04 the patient presented with shingles on his right arm near the injection site. It was reported that PCR testing was requested. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information fro the physician indicated that on 2/5/04 the patient developed shingles. The rash was described as shingles vesicle. The number of lesions were too numerous to count and they were distributed on the inner right arm, right palm. T1 and T2 dermatomes. The herpes zoster was described as coalescent vesicular patches scattered throughout T1 and T2 dermatone and right arm and chest. His maximum temperature was 98.6 and no other systemic symptoms were noted. It was reported that the patient did not have a history of chicken pox and no recent exposure to chicken pox was noted. The physician reported that a rash did not occur at the site of injection or elsewhere within 42 days of vaccination. The patient was started on cephalexin for infection on 2/10/04. A specimen was obtained from a vesicle and sent for PCR analysis on 2/10/04. The duration of the herpes was reported as 6 days and the patient recovered, however the patient's recovery status was also reported as evolving, remains anill. Follow up information indicated that the shingles began on 2/4/04, not 2/5/04 as previously reported. It was reported that the shingles was in the right arm, dermatoid in T1 and T2 distribution. There was no history of previous chicken pox thus presumably the zoster is from the vaccine strain. Samples have been sent for testing. Additional information has been requested.				Y					Y	01/06/2003	02/04/2004	394	Body temp: 98.6	PVT	PVT			NONE		WAES0402USA00541	1						1	Herpes zoster; Rash vesicular	FLU3~SANOFI PASTEUR~~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0652M~3~IM~~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0925M~1~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0198M~1~SC~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0217623	05/26/2004		36.0			F	05/21/2004	Information has been received from via a health professional through an enhanced surveillance program conducted by the Centers for Disease Control and Prevention concerning a 36 year old female patient, who is in the military, with a history of migraine headaches who on 1/7/03 was vaccinated with a dose of MMR. Secondary concomitant therapy on 1/7/03 included doses of hepatitis A vaccine, yellow fever virus vaccine, influenza virus vaccine, meningococcal vaccine, poliovirus vaccine, tetanus toxoid, and typhoid vaccine. Two to three days later, on approximately 1/9/03, the patient developed a migraine headache. She had a history of migraine headaches monthly prior to vaccination. After vaccination, the headaches increased in severity and frequency to several times per week. It was reported that the patient had a permanent disability from the migraines. On 12/20/03 an MRI of the brain with contrast was normal. Her medical records had been requested. It was reported that the patient had a permanent disability from the migraines.				Y				Y	N	01/07/2003	01/09/2003	2	Brain MRI with contrast was normal. Electrocardiogram was normal.	OTH	OTH			Migraine		WAES0405USA01264	1						2	Condition aggravated; Fatigue; Injection site mass; Injection site pain; Injection site swelling; Migraine; Pruritus; Condition aggravated; Migraine	ANTH~EMERGENT BIOSOLUTIONS~FAV063~1~SC~UN~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~40200040~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0717M~1~IM~UN~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~U1428~1~SC~UN~POLIO VIRUS, INACT. (POLIOVAX)~1|MEN~SANOFI PASTEUR~UB080AA~1~SC~UN~MENINGOCOCCAL (MENOMUNE)~1|MMR~MERCK & CO. INC.~0969M~3~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|TTOX~SANOFI PASTEUR~U0818AA~4~IM~UN~TETANUS TOXOID (NO BRAND NAME)~1|TYP~SANOFI PASTEUR~U1073~1~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|YF~SANOFI PASTEUR~UB320AA~1~SC~UN~YELLOW FEVER (YF-VAX)~1|ANTH~EMERGENT BIOSOLUTIONS~FAV063~1~SC~~ANTHRAX (BIOTHRAX)~2|FLU3~SANOFI PASTEUR~40200040~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~MERCK & CO. INC.~0717m~1~IM~~HEP A (VAQTA)~2|IPV~SANOFI PASTEUR~U1428~1~SC~~POLIO VIRUS, INACT. (IPOL)~2|MEN~SANOFI PASTEUR~UB080AA~1~SC~~MENINGOCOCCAL (MENOMUNE)~2|MMR~MERCK & CO. INC.~0969M~3~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~2|YF~SANOFI PASTEUR~UB320AA~1~IM~~YELLOW FEVER (YF-VAX)~2	USA	Disabling	Influenza
0222063	05/27/2004	PR	34.0	34		F	05/21/2004	After being administered with Anthrax vaccine, the same day experienced pain, swelling, itching in the arm. Continues symptoms 2 days after. Symptoms worse; reaction locally is 4x4.				Y					U	05/19/2004	05/19/2004	0		MIL	MIL		NONE	NONE			1						1	Pain; Pruritus; Swelling	ANTH~EMERGENT BIOSOLUTIONS~FAV084~5~~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1133AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~SANOFI PASTEUR~W1366~UNK~~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0222203	06/02/2004	NY		86		M		This subject is a 86 year old male who was admitted to the hospital due to increasing back pain over the past several weeks and increasing SOB over the last week while enrolled in a Comparative Randomized Study of Safety and Immunogenicity of a Non-Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine versus an RSV Vaccine Adjuvanted with Aluminum Phosphate when Administered Concomitantly with a Licensed Influenza Vaccine in High Risk Adults > or = 65 years of age. The subject received 2 doses of RSV vaccine or Placebo and Influenza vaccine. The last dose prior to the event was given on 10/22/03. The subject developed increased back pain and shortness of breath, and was admitted to hospital 169 days post immunization on 4/8/04. Treatment and discharged date were not reported. The subject's outcome was unknown at the time of this report. The increasing back pain over the past several weeks and increasing SOB over the last week were reported by the investigator as unrelated to the study vaccine. Additional information received on 5/25/04. Subject was admitted to the hospital for increasing back pain, difficulty urinating and difficulty ambulating for several weeks. Shortness of breath and wheezing for 1 week. Subject was diagnosed with primary lung cancer with metastasis to the bone 170 days post immunization. Investigations included a chest CT on 4/9/04 which revealed a left upper lobe lung mass most likely primary lung neoplasm with metastasis. Abdomen CT on 4/9/04 revealed metastasis to caudate lobe of liver, left adrenal mass, multiple kidney lesions and multiple metastases to vertebrae. A right L3 core biopsy on 4/16/04 showed metastatic adenocarcinoma. Subject underwent several days of radiation and was maintained on normal routine medications. Subject has not recovered and was discharged to hospice 11 days later on 4/19/04. Subject discontinued the study on 4/23/04. Additional documents available with source files: Pathology and Laboratory report - Right L3 Transverse Process Core Biopsy; CT Abdomen with and without contrast; CT Chest with and without contrast; Concomitant medications. Additional information received 5/26/04. Notified by spouse that while at home on hospice, subject died on 5/13/04, 204 days post immunization. The subject's death was reported by the investigator as unrelated to the study vaccine. Additional documents available with source files: Pathology and Laboratory report - Right L3 Transverse Process Core Biopsy; CT Abdomen with and without contrast; CT Chest with and without contrast; Concomitant medications.  Nurse follow up on 06/14/04 states: bowel incontinence; thrombosis; diverticulitis; GERD; Lymphedema; Arthrosclerosis; Cholecystitis; Aortic aneurism; Weakness; Cough.  6/25/04 Death certificate received which revealed COD to be cardiac arrest, Myocardial infarction, coronary artery disease & metastatic lung cancer.	Y	05/13/2004			Y	11			N	10/22/2003			Chest CT on 04/09/04-Left upper lobe lung mass most likely primary lung neoplasm with metastasis to caudate lobe of liver, left adrenal mass, multiple kidney lesions and multiple metastases to vertebrae. Right L3 core biopsy on 04/16/04-Netastatic adenocarcinoma.	UNK	UNK			The subject received dose 1 of RSV vaccine or Placebo and Influenza vaccine on 10/11/02.  Additional information received 05/25/04.  Hypertension, chronic ischemic heart disease, CHF, MI 1994, CABG 1004, Arthritis, Hypercholesterolemia, Angina		200401445	1						1	Arteriosclerosis; Asthenia; Back pain; Bone neoplasm; Cardiac arrest; Cholecystitis; Colitis; Coronary artery disease; Cough; Dyspnoea; Dysuria; Faecal incontinence; Gait disturbance; Gastrointestinal disorder; Hepatic neoplasm; Laboratory test abnormal; Lung neoplasm malignant; Lymphoedema; Myocardial infarction; Thrombosis; Vascular anomaly; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0222208	06/02/2004	NJ	36.0	36		M	05/14/2004	Bilateral elbow pain at points of elbows starting 3-4 days after first Anthrax injection and seems to have continued and worsened with two subsequent injections. Hot sharp sensation especially weight training.									U	10/27/2003	11/01/2003	5	UNK	MIL	MIL	NONE	NONE	NONE			1						1	Pain; Joint range of motion decreased; Skin burning sensation	ANTH~EMERGENT BIOSOLUTIONS~FAV071~1~SC~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~765754~7+~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4030013~1~~~SMALLPOX (DRYVAX)~1|ANTH~EMERGENT BIOSOLUTIONS~~1~SC~UN~ANTHRAX (BIOTHRAX)~2	USA		Influenza
0222276	06/03/2004	UT	64.0	64		F	05/26/2004	Client called 5/26/04 to report adverse reaction after flu shot given 11/05/2003. She stated she broke out in a rash that on right arm spreading to most of body. Treated with steroid then antihistamines. When she tries to wean off medications (antihistamines), rash reappears: has never had it completely resolved.									U	11/05/2003	11/07/2003	2	Skin biopsy	PUB	PVT	NONE	NONE				1						1	Rash	FLU3~EVANS VACCINES~76570~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0222364	06/03/2004	CA	38.0	38		M	02/25/2004	38 year old man received first dose of Anthrax vaccine. Within approximately one week he experienced vomiting, sore throat, body aches, and low grade fever.									Y	09/30/2003	10/07/2003	7	None	OTH	OTH	Allegra	Scratchy throat	Allergy to amoxicillin, hay fever.		03AV0039	1						1	Pain; Pharyngolaryngeal pain; Pyrexia; Vomiting	ANTH~EMERGENT BIOSOLUTIONS~FAV077~1~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1137EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0222208	06/04/2004	NJ	36.0	36		M	06/04/2004	Anthrax Vaccine #1 10/27/03 States that initially he had no problems for the first week after receiving the vaccine.  States that after the first week he started having a severe burning sensation on the left elbow.  In a couple of days after the burning sensation appeared on the left elbow, he started having a burning sensation on his right elbow.   States that this sensation was aggravated with movement.  He was placed on Motrin, which helped a little.  Rated the pain as a 7-8 on a pain scale of 0-10 initially.  Rates the pain now as a 2 on a pain scale of 0-10.  States that the pain is concentrated on the tip of both elbows and is constant, only the intensity changes.    Anthrax Vaccine #2 11/14/03 States that the pain persisted. Continues to be aggravated with movement.   Anthrax Vaccine #3 12/12/033/045/12/04 As above. Continues to have bilateral elbow pain and went on sick call to have both elbows checked.  Braces for tennis elbows were prescribed and the physician called for advice.  The patient was referred.									U	10/27/2003	11/03/2003	7	None	MIL	MIL	Allegra 180 mg qd	None	None			1						2	Pain; Joint range of motion decreased; Skin burning sensation	ANTH~EMERGENT BIOSOLUTIONS~FAV071~1~SC~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~765754~7+~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4030013~1~~~SMALLPOX (DRYVAX)~1|ANTH~EMERGENT BIOSOLUTIONS~~1~SC~UN~ANTHRAX (BIOTHRAX)~2	USA		Influenza
0222401	06/07/2004	ID	62.0	61		F	05/17/2004	Problems raising my arm up past level. Constant sharp pain in area of injection (upper arm and shoulder) loss of strength in arm. Have problems lifting. Have problems with everyday grooming (combing hair and anything that requires arm up.) Physical therapy didn't help.									N	11/04/2003	11/05/2003	1		PVT	UNK						1						1	Asthenia; Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U1070AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0675M~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0222660	06/15/2004	MT	29.0	39		M	02/08/2004	Anaphylactic reaction: SOB, swelling over face, extremities, hives, flushing. Treated with Epinephrine and Benadryl CO2. Transported to hospital for further treatment.  Nurse follow up on 06/28/04 states: ADD: urticaria.				Y					Y	11/01/2003	11/01/2003	0		MIL	MIL			Allergy;			1						1	Anaphylactic reaction; Dyspnoea; Face oedema; Flushing; Oedema peripheral; Urticaria	FLUX~UNKNOWN MANUFACTURER~765754~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0222729	06/16/2004	FL	50.0	50		M	06/16/2004	23 SEPT 99 RECEIVED ANTHRAX #6 AND ON 15 OCT 99 RECEIVED INFLUENZA. ON 18 OCT THROUGH 30 OCT NOTICED HEADACHES THAT REQUIRED MEDICAL ATTENTION. ON 01 NOV DEVELOPED LESIONS ON EAR AND NOTICED SPOTS IN VISUAL FIELD OF LEFT EYE. EAR LESIONS CLEARED IN 3-4 DAYS AND PT WENT ON TO DEVELOP LEFT CENTRAL VISUAL LOSS BY 22 NOV 99. NO FURTHER CHANGES IN VISION SINCE THAT TIME.  26 Jan 00:  Examined by Dr.  His impression which includes no definitive diagnosis is provided in attached letter dated Jan 26, 2000. Letter reports: Pt has evidence for a left optic neuropathy. A definite possibility would be post-vaccination optic neuropathy from influenza. I cannot put that together with his red ear nor with the cells in the vitreous. I do not think anthrax is a possibility here. Another possibility would be a nonarteritic anterior ischemic optic neuropathy, however, I would not anticipate that would cause cells in the vitreous. I do not think that his MRI is consistent with a diagnosis of multiple sclerosis. Nurse follow up on 06/28/04 states: ADD: swelling of ear, eschar of ear, iritis.				Y					N	10/15/1999	10/18/1999	3	o Ear culture Nov 99: culture lost. o CXR 29 Nov 99: except for scoliosis normal chest. o MRI Brain 03 Nov 99: Is within normal limits for age. Solitary punctuate focus of T2 prolongation in right frontal subcortical white matter. o  prostAg, ANA, Westergren 23 Nov 99: normal o Tosoplasma IGG and IGM, HIV, urinalysis 23 Nov 99: normal o CBC, electrolytes, lipid panel, 11 Jan 00: normal o Lyme Disease AB screen  03 Dec 99: is seronegative o 03 Dec 99: B Henselae IGG:1:64  B Quintana IGG: 1:64      (ref ranges IGG < 1:64;        IGM: < 1:20                IGM: <1:20         IGM< 1:20)  o Alpha 1& 2, Beta, andGamma Globulin 11 Jan 00: normal o Albumin EP, Total Protein EP, and Protein, total  11 Jan 00: normal	MIL	MIL	DENIES	DENIES	DENIES			1						1	Blindness; Dermatitis exfoliative; Headache; Laboratory test abnormal; Oedema; Optic neuritis; Skin ulcer; Uveitis; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~U0135aa~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0222743	06/17/2004	OR	62.0	58		M	06/02/2004	Dizziness. Pt came to emergency care unit with these symptoms. Swelling in legs.  Tachycardia: chronic, patient at baseline and no charge to EKG today. LE edema; no crackles, able to lie completely flat without SOB suspect  Exp.  6/30/2004. Reported by phone									Y	10/10/2003	10/14/2003	4		UNK	PUB						1						1	Dizziness; Dyspnoea; Oedema peripheral; Swelling; Tachycardia	FLU3~SANOFI PASTEUR~U1099AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0222869	06/18/2004	NY	43.0	43		F	06/18/2004	Client was here on 3/14/04, with an interpreter.  She was complaining of pain in her left shoulder.  Stating that this pain started since she received her Flu shot dating 12/17/03.  On arrival, she demostrated limited range of motion in left arm and unequal hand grips with weakness to the left hand. Client did recieve Td (RA), MMR, IPV on 1/15/04.  And the recieved the same shots on 9/30/03(with TD in LA).				Y					U	12/17/2003	06/14/2004	180	Per clinet, she states she has been in the emergency room for x-rays and care.	PUB	PUB		unknown	Known to clinic for treatment of LTBI.			1						1	Hemiparesis; Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~U1124AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0222950	06/22/2004	SC	13.0	13		M	05/04/2004	2/5/04 Seen with bilateral leg pain. 3/3/04 Seen with bilateral calves and knee pain. 3/22/04 Seen with fatigue, muscle weakness legs, paresthesias legs, difficulty running and climbing of stairs. 4/1/04 Diagnoses: Chronic Guillain Barre, Chronic inflammatory, Demyelinating Polyradiculoneuropathy.  Nurse follow up on 07/21/04 states: CIDP, lethargy, headache, Pruritis, Diplopia.									N	12/10/2003	12/28/2003	18	Lumbar puncture: Elevated protein, CSF abnormal	PVT	PVT		NONE	NONE			1						1	Arthralgia; CSF test abnormal; Diplopia; Fatigue; Headache; Laboratory test abnormal; Lethargy; Muscular weakness; Neuropathy; Pain; Paraesthesia; Pruritus	FLU3~SANOFI PASTEUR~U1097AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0223148	06/22/2004	MI	4.0			M	05/28/2004	Information has been received from a registered nurse concerning a 4 year old male patient with an egg allergy who was vaccinated with a dose of MMR (lot # unavailable) by another health care provider. According to the patient's mother, the patient developed a runny nose and sinus congestion that lasted 3 months after he was vaccinated. Follow up information was received from a registered nurse. It was noted that the patient was also vaccinated with a dose of influenza virus vaccine (unspecified) (manufacturer unknown). According to the reporter, the patient's mother stated that the patient had symptoms persisting for months after receiving a flu and MMR injection a the pediatrician's office. It was reported that the patient had recovered. Additional information is not expected.				Y					Y				NONE	OTH	OTH			Concurrent conditions: Egg allergy.		WAES0310USA00363	1						1	Rhinorrhoea; Sinus congestion	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0223157	06/22/2004		1.25	1	.3	M	05/28/2004	Information has been received from a pharmacist concerning his 15 month old son with no prior medical history or allergies who on 10OCT2003 was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. Concomitant vaccination received on 10OCT2003 included varicella virus vaccine live and influenza virus vaccine. There was no other concomitant medication. On 18OCT2003 the patient developed a rash of small red dots on his back and stomach and a slight fever. The next day, the rash was on his head but the other area were starting to fade, he was afebrile and napping longer than usual. Medical attention was sought and he was treated with Tylenol as needed. Additional information was requested.				Y					U	10/10/2003	10/18/2003	8	body temp 10/18/2003: slight fever. body temp 10/19/2003: afebrile	UNK	UNK			NONE		WAES0310USA02281	1						1	Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~~UNK~~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0223162	06/22/2004		23.0	23		F	05/28/2004	Information has been received from a nurse practitioner concerning a 23 year old female with no prior medical history and no allergies who on 07OCT2003 was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. Concomitant vaccination on 07OCT2003 included a dose of influenza virus vaccine and diphtheria toxoid + tetanus toxoid + typhoid vaccine inactivated. There was no other concomitant medication. On 21OCT2003, two weeks later, the patient developed a rash with small red bumps, no itching, and was afebrile. The patient's rash persisted. Medical attention was sought and no treatment was required. Additional information has been requested.									U	10/07/2003	10/21/2003	14	body temp 10/21/03: afebrile	UNK	UNK			NONE		WAES0310USA03074	1						1	Rash	DT~UNKNOWN MANUFACTURER~~UNK~~~DT ADSORBED (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0276N~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0223173	06/22/2004	CT	4.0	4		F	05/28/2004	Initial and follow up information has been received from a registered nurse concerning a 4 year old female with no known allergies who on 14NOV2003 was vaccinated with the second dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live, subcutaneous administration in the left upper arm. On the same day, the patient was vaccinated with poliovirus inactivated in the left arm, influenza virus vaccine in the right arm, and diphtheria toxoid + pertussis vaccine + tetanus toxoid in the right arm all administered intramuscularly. Immediately after vaccination with measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live, the patient developed a 3 to 4, 1-2 cm hives next to the injection vaccination site. The nurse reported that the poliovirus vaccine was administered on the left arm but at a different location. No treatment was required and the patient was monitored in the office. Within 15 minutes of the vaccination, the patient recovered from the hives. The nurse reported that the hives were self limited and not associated with any other therapies. Additional information is not expected.				Y					Y	11/14/2003	11/14/2003	0	UNK	PVT	PVT			NONE		WAES0311USA02172	1						1	Urticaria	DTAP~SMITHKLINE BEECHAM~~5~IM~~DTAP (INFANRIX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~SANOFI PASTEUR~~4~IM~~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0666N~2~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0223181	06/22/2004	CA	68.0	68		F	06/22/2004	stomach cramps Feeling of compression of entire thorax pain at the back of the neck extream flushing elevated blood pressure									Y	10/31/2003	10/31/2003	0		UNK	UNK		Allergic swelling of left arm from spider bite				1						1	Abdominal pain; Blood pressure increased; Flushing; Neck pain; Abdominal pain; Anaphylactic shock; Chest pain; Dyspnoea; Erythema; Heart rate increased; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U1092AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0987N~2~IM~LA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~0987N~UNK~~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0223263	06/23/2004	CA	1.4	1	.3	F	05/28/2004	Information has been received from a mother concerning her 16 month old daughter with no known allergies who on 12/11/03 (previously reported as 12/19/03) was vaccinated IM into the right upper thigh with a first dose of MMRII (Lot # 646121/0611N).  On the seventh day, on approximately 12/26/03, the pt developed a few vesicles and then over the week some more were noted. A brief rhinorrhea was reported as well. The mother reported that the child may have had atypical measles and she was unsure of what she was seeing. A facial rash was also noted and reported as almost like roseola. The pt had no fever or wheezing, was playful but minimally clinging. The mother reported that the child would be assessed at the clinic. In follow up information from a physician, it was noted that the pt developed a rash on 12/20/03. The pt was seen for an office visit and was diagnosed with right otitis media, acute upper respiratory infection, rhinorrhea and viral exanthem. The physician reported that at the time of vaccination, the pt had serious otitis media, purulent rhinitis and was under treatment with Pediazole. Concomitant vaccinations on 12/11/03 included a dose of Trihibit (Lot # SU1257AB), a dose of Fluzone (Lot # U1287AA) and tuberculin purified protein derivative, reported as PPD (Lot # C12628A). The physician reported that the pt did not have adverse events following prior vaccinations.  It was reported that the pt recovered on either 01/06/04 or 01/10/04.  Additional information is not expected.				Y					Y	12/11/2003	12/11/2003	0	UNK	PVT	OTH	Tuberculin purified protein derivative (AP, Lot # C12628A); Pediazole;	Otitis media serious NOS; Rhinitis purulent;	NONE		WAES0401USA00072	1						1	Otitis media; Pharyngitis; Rash; Rash vesicular; Rhinorrhoea	DTAPH~SANOFI PASTEUR~SU1257AB~UNK~IM~~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~U1287AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0611N~1~IM~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0223276	06/23/2004		1.0	1	.0	M	05/28/2004	Information has been received from a physician's assistant concerning a 12 month old male pt who on 01/15/04 was vaccinated with a dose of MMRII (Lot # 645405/0132N). Secondary suspect therapy included vaccination on 01/15/04 with a dose of varicella virus vaccine live (Lot # 644251/1154M). Concomitant medications included influenza virus vaccine and tuberculin purified protein derivative (PPD test). About a week later the mother reported a maculopapular rash on the trunk (also reported as rash broke out on 01/21/04). It was reported that as of 01/27/04 the child also had conjunctivitis. The physician assistant did not believe that the conjunctivitis was related. Unspecified medical attention was sought. It was noted on 01/27/04 that the pt was still being treated for the events. Treatment included Benadryl, Caladryl and Bleph-10 ointment which was prescribed for the conjunctivitis. Additional information has been requested.				Y					U	01/15/2004	01/21/2004	6	UNK	OTH	OTH	PPD;	UNK	UNK		WAES0401USA02080	1						1	Conjunctivitis; Rash maculo-papular	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0132N~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1154M~UNK~~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0223452	06/29/2004	NY	1.5	1	.0	F	06/27/2004	Herpes Zoster on trunk. Began 6/15/04.									U	12/17/2003	06/15/2004	181		PVT	PVT		NONE	NONE			1						1	Herpes zoster	FLU3~SANOFI PASTEUR~V1293AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0575N~1~SC~~VARICELLA (VARIVAX)~1	USA		Influenza
0223559	06/30/2004	CA	36.0	36		F	06/03/2004	Brachial neuritis developed. Started with shoulder/neck problem 11/15 and then left calf at home. Appointment here 1/7/04.				Y					U	10/29/2003	10/30/2003	1	Labs;EMG; MRI's, specialty referral	OTH	OTH	NONE	NONE				1						1	Radiculitis brachial	FLU3~SANOFI PASTEUR~U1087AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0203155	07/02/2004	AL	44.0	43		M	06/29/2004	Possible type 1 hypersensitivity reaction following multiple vaccines. Awoke the next morning with generalized urticaria and angioedema requiring hospitalization.				Y	Y	5			Y	03/22/2003	03/23/2003	1	NONE	MIL	MIL	NONE	NONE	NONE			1						2	Angioneurotic oedema; Hypersensitivity; Urticaria	ANTH~EMERGENT BIOSOLUTIONS~FAV074~2~SC~~ANTHRAX (BIOTHRAX)~2|FLU3~SANOFI PASTEUR~~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|HEP~GLAXOSMITHKLINE BIOLOGICALS~5379A4~2~IM~~HEP B (ENGERIX-B)~2|MEN~SANOFI PASTEUR~UO185AB~1~~~MENINGOCOCCAL (MENOMUNE)~2|TYP~SANOFI PASTEUR~U1203~1~IM~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~2	USA	Hospitalisation	Influenza
0223601	07/02/2004	CO				F	06/30/2004	From initial information received on 6/28/04 from the patient regarding an adverse event occurring in the USA, it was reported that the female patient (age and date of birth not reported) received a FLUZONE vaccination on 10/8/03. The lot number, site and route of administration were not provided. Two days later, on 10/10/03, the patient experienced a raging fever, chills aching all over and a pain in her spine from the neck down, which she described as feeling like someone had hit her in the back with an axe. She was seen by her primary care physician, who treated her for pulmonary problems. On 11/30/03, the patient was admitted to the hospital and told by a cardiologist that she had congestive heart failure. The patient's recovery status was not provided.				Y	Y				U	10/08/2003	10/10/2003	2		UNK	UNK					200402258	1						1	Back pain; Cardiac failure congestive; Chills; Pain; Pyrexia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0223745	07/08/2004		58.0	57		F		A report was received from a healthcare professional in the USA on 6/25/04 concerning a 45 year old female vaccinee. No details were provided regarding the vaccinees medical history or whether she was taking any other medications. In October 2003, the vaccinee received an IM injection of Fluvirin. At an unspecified time after vaccination, the vaccinee developed a frozen shoulder syndrome, which she attributes to the Fluvirin. She is now receiving physical therapy for this problem. Further information will be sought. Follow up received on 15Nov04 from a health care professional in the US. The vaccinee has been identified as a 59 year old female who experienced frozen shoulder syndrome and injection site oedema after receiving and Fluvirin vaccination (batch 765753) in her left deltoid on 22Oct03. The vaccinee still experiences frozen shoulder syndrome, despite being provided with long term physical therapy treatment. The vaccinee has continued reduced mobility and pain 13 months after vaccination. The vaccinee's medical history includes C-section in 1982 and an allergy to anaestetic during the operation. She also has an allergy to penicillin since childhood and macrolides since the age of 55. Her concomitant medications include Hydrochlorothiazide, 25mg daily, for high blood pressure. The reporter considers the reaction serious due to disability and the vaccinee has been advised against influenza vaccination in the future.								Y	U	10/22/2003				UNK	UNK	Hydrochlorothiazide		Penicillin allergy childhood ongoing, macrolides allergy, age 55, on going, C-section 1982, anaesthetic allergic reaction during C section 1982.		CVOX200400227	1						1	Arthropathy; Hypertension; Hypokinesia	FLU3~EVANS VACCINES~765753~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0223752	07/08/2004	CA				F	06/23/2004	Tender node palpable at the base of the neck above clavicle (lymphadenopathy).									U		10/19/2003		NONE	UNK	UNK	UNK		UNK			1						1	Lymphadenopathy; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0223808	07/09/2004	TX	68.0	68		M	07/09/2004	Adverse event:  Guillain-Barre syndrome presenting on 11/18/2004 in conjunction with Beta-hemolytic streptococcal pneumonia.  Individual was also post-op from craniotomy for meningioma on 11/09/1998 and had been continuously treated with IV Decadron and Mannitol since that procedure for ongoing cerebral edema.  Yeast was also present in tracheal aspirates at presentation; not cultured for campylobacter yersenia nor tested for CMV.  He developed ARDS and sepsis and despite treatment with plasmapheresis and IVIG died 66 days after presentation with multiple organ failure. Manufacturer of vaccine was Connaught, lot 0980530 or possibly 0986530.  Influenza vaccine givne IM left deltoid.  Exp 06/99.  He had had influenza vaccine for at least the preceeding 3 years.  Nurse follow up on 07/26/04 states: atrial fib, renal failure, hypotension.	Y	01/22/1999			Y	60			N	11/03/1998	11/17/1998	14	EMG consistent with G-B syndrome.  Two neurologists agreed with diagnosis.  Sputum culture from admission positive beta-hemolytic strep, not group A. WBCs at presentation 48,000 with a left shift.	UNK	UNK	decadron,mannitol	Vaccine given at pre-op physical for meningioma resection.  Afebrile and well at time of exam except for headache and irritibility/personality changed referable to right frontal meningioma.	none except meningioma			1						1	Acute respiratory distress syndrome; Atrial fibrillation; Guillain-Barre syndrome; Hypotension; Laboratory test abnormal; Leukocytosis; Multi-organ failure; Pneumonia; Renal failure; Sepsis	FLUX~UNKNOWN MANUFACTURER~0980530~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0223814	07/11/2004	MO	26.0	25		M	07/11/2004	DESCRIPTION BY PHYSICIAN:  SEVERE ILLNESS WHEN GIVEN FLU SHOT: HIGH FEVER, MALAISE									Y	12/08/2002	12/08/2002	0	NONE	MIL	MIL	NONE	NONE DISCLOSED	NONE			1						1	Influenza like illness; Malaise; Pyrexia	FLUX~UNKNOWN MANUFACTURER~UO956AA~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0216738	07/12/2004	NY	5.0	5		F	07/09/2004	Initially reported to Manufacturer 2/3/04. This form requested by VAERS				Y					Y	12/18/2003	12/24/2003	6	Flumist given 12/18/03 Flumist given 12/18/03 diagnosed with pneumonia 12/24/03 by pediatrician	PVT	UNK		Chronic cough x yrs	cat dog dust sensitivity			1						2	Asthenia; Laboratory test abnormal; Pneumonia; Sinus bradycardia; Pneumonia; Unevaluable event	FLUN3~MEDIMMUNE VACCINES, INC.~400015P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500015P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Emergency room visit	Influenza
0223963	07/15/2004	IL				F	07/05/2004	Two weeks after shot, pain started in feet. Waking me up 2 times a night and worked into pain all the time. Mainly in left leg to upper leg and right leg. Pain got intense. Took time to find out what was wrong. (Steroids - Lumbar Puncture.) Per annual report-Peripheral neuroopathy, RSD, numbness, weakness and pain   Nurse follow up on 08/19/04 states: cramps in thighs; numbness; weakness; thorasic myelopathy;				Y	Y	7		Y	N	10/02/2001	10/15/2001	13	CSF normal; lab test abnormal; emg abnormal	OTH	PVT	NONE	NONE	Irritable bowel syndrome;			1						1	Asthenia; CSF test abnormal; Guillain-Barre syndrome; Hypoaesthesia; Laboratory test abnormal; Muscle twitching; Myopathy; Neuropathy peripheral; Pain; Pain in extremity; Paraesthesia; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0223181	07/19/2004	CA	68.0	68		F	07/12/2004	Information has been received from a physician concerning a 68 year old female with a history of swelling in her arm after vaccination with a pneumococcal vaccine (manufacturer unknown)(WAES 0407USA00678) who on 10/31/03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647797/0987N). Concomitant therapy included influenza virus split virion 3v vaccine inactivated (Fluzone). On 10/31/03, approximately one minute after vaccination with the pneumococcal 23v polysaccharide vaccine, the pt developed anaphylactic shock. The pt initially developed cramping in her abdomen, then a squeezing of her thorax. The pt experienced stiffness of her neck, shortness of breath, an increase in pulse and turned the color of scarlet. The pt was advised to lie down while still at the clinic and the event slowly passed after approximately 5 or 10 minutes. Subsequently, the pt was recovered from the anaphylactic shock after half an hour. Additional information has been requested. Upon internal review, the pt's anaphylactic shock was considered to be an other important medical event (OMIC). Follow UP: Conflicting information has been received from an office nurse. The nurse reported that the patient was not seen in the office on 31OCT2003. The nurse reported that the patient had an allergy to influenza virus split virion 3v vaccine inactivated (FLUZONE) therapy, and subsequently, was not a concomitant therapy. The patient had been seen in the physician's office since 1993, and there was no record of the patient actually receiving a vaccination with influenza virus split virion 3v vaccine inactivated (FLUZONE).									Y	10/31/2003	10/31/2003	0	Total heart beat count increased.	OTH	OTH			Swelling arm; Specific allergy		WAES0407USA00667	1						2	Abdominal pain; Blood pressure increased; Flushing; Neck pain; Abdominal pain; Anaphylactic shock; Chest pain; Dyspnoea; Erythema; Heart rate increased; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U1092AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0987N~2~IM~LA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~0987N~UNK~~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0218387	07/20/2004					U	03/24/2004	This case was considered medically important (OMIC). Information regarding Flumist was received from an attorney regarding a patient who experienced Guillain Barre. The patient received the vaccine on an unspecified date. Relevant medical history was not provided. Indication for Flumist was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. An attorney reported that a patient experienced Guillain Barre following receipt of Flumist. The attorney declined to provide any further information due to potential litigation; no lawsuit has been filed. The attorney stated that if improperly shipped and stored, Flumist had been administered to a patient, then interstate commerce could be involved if a patient got sick. The attorney mentioned, there is a bill in Congress which lists influenza as covered from compensation, which is an attempt by your company to limit liability towards problems like this. No additional information was available at the time of this report.									U				UNK	OTH	OTH	UNK	UNK	UNK		HQWYE014122MAR04	1						2	Guillain-Barre syndrome; Guillain-Barre syndrome	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0224168	07/20/2004	NJ	6.0	6		F	05/18/2004	Follow up information received on 4/26/04, provided demographic information, medical history, administration of initial dose of Flumist and subsequent dosing information and date, lot number and site of herpes lesion. Information regarding Flumist was received from a physician regarding a 6 year old female patient who received a first dose on 12/11/03, and developed herpes. The patient's concurrent illness includes food allergy. Indication for Flumist was immunization. Product was administered on 12/11/03. Dose regimen was 1 dose. Patient was not taking concomitant therapy. On 12/16/03, a 6 year old female patient developed herpes on top of lip, under nose, after receiving her first dose of Flumist on 12/11/03. Zovirax ointment was prescribed, and patient recovered. On 2/19/04, the child received a second dose of Flumist, and the reporter stated, no herpes outbreak, but 7 days later mom called to report that mom had herpes outbreak. The reporter also indicated that the mother received Zovirax and recovered.									Y	12/11/2003	12/16/2003	5	UNK	OTH	PVT	NONE	NONE	Food allergy		HQWYE350105APR04	1						1	Herpes simplex	FLUN3~MEDIMMUNE VACCINES, INC.~500033P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0224169	07/20/2004	OH	9.0	9		M	06/15/2004	Follow up information pertaining to patient's medical history was received from a physician. Information regarding Flumist was received from a healthcare professional regarding a 9 year old male who experienced malaise and fever. At 9 years of age, the patient received his first dose on 11/19/03. Relevant medical history: none. Indication for Flumist was immunization. Product was administered on 11/19/03. Dose regimen was 1 dose. Patient was not taking concomitant therapy. On 11/24/03, approximately five days after receiving Flumist, the patient developed fevers of 102-104 that lasted for about three days. The patient also experienced malaise. All symptoms resolved in about five days. It was reported that the patient's brother received the Flumist on the same date and did not experience problems. The physician additionally noted in his follow up that it is unknown if the fever was vaccine related or whether the patient had some other illness since he did not have a chance to examine him. No additional information is was available at the time of this report.									Y	11/19/2003	11/24/2003	5	UNK	PVT	PVT	NONE	NONE	UNK		HQWYE596526APR04	1						1	Malaise; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0224198	07/21/2004	IN				M	07/11/2004	Lump developing on left hand between fourth and fifth digit. Has appointment to see family Dr									U				PPD test.	MIL	MIL						1						1	Skin nodule	ANTH~EMERGENT BIOSOLUTIONS~FAV064~1~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U0983AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0224220	07/21/2004	AZ	68.0	68		F	07/14/2004	Event: pneumococcal and influenza vaccine. Limping while taking walks, extreme muscle weakness, especially in right arm and right leg above knee. Walking and climbing stairs has become more difficult. Lab results show no arthritis. Have used Vioxx.				Y					N	10/16/2002	10/19/2002	3	blood test dated 8/8/03 show no systemic inflammatory joint disease or connective tissue disease.	PVT	UNK						1						1	Difficulty in walking; Gait disturbance; Muscular weakness	FLU3~SANOFI PASTEUR~U09711414~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~10SI1~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0224303	07/23/2004		1.5			F		Seizure event, approx 20 min. Pt had 1 seizure episode prior to Fluvirin and was taken to the ER and found  to have a UTI and fever. After Fluvirin was given approx 20 min later mother reported child had 1 seizure and was taken to hospital and again found to have a UTI and fever that started developing. Currently this child is being worked up for seizure disorder unrelated to Fluvirin event.									U					UNK	UNK						1						1	Convulsion; Pyrexia; Urinary tract infection	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0224332	07/26/2004	CA	44.0	44		F	07/06/2004	Possible transverse myelitis, i.e. sudden onset of weakness, decreased sensation, numbness of upper and lower extremities, up to sternum with urinary retention. Sudden onset 10/12/03. States got influenza vaccination 10/08/2003.  Nurse follow up on 07/27/04 states: chest pain; nausea; vomiting; constipation; back pain; balance impaired. Per annual report-Pt has hyper reflexion, mild spasticity, gait disturbance and urinary incontinence. Pt work up at hospital with neurologist and neurosurgeon.  Neurologist thinks it secondary to cervical myelopathy secondary cervical stenomi-pt underwent surgery care.				Y	Y	11		Y	N	10/08/2003	10/12/2003	4	MRI; Cx spine: multilevel disk disease; Somatosurgery evidence potential. MRI abnormal	PUB	PUB		UTI	Asthma; Sleep apnea; Depression; LBP; CHF; Anxiety; Peripheral edema; Eardrum perforation 2ndary to trauma; Lowback pain; Allergy; Obesity; Spinal stenosis; Drug abuse; alcohol abuse; GERD; Insomnia;			1						1	Asthenia; Back pain; Bladder stenosis; Chest pain; Constipation; Depressed level of consciousness; Gait disturbance; Hyperreflexia; Hypoaesthesia; Laboratory test abnormal; Muscle spasticity; Myelitis transverse; Myelopathy; Nausea; Urinary incontinence; Urinary retention; Vomiting	FLU3~EVANS VACCINES~765143~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0224434	07/28/2004	CA	32.0	32		F		None stated.									U	10/30/2003			NONE	PUB	OTH	Lithium Carbonate		Bipolar disorder; ITP			1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0224576	07/31/2004	GA	28.0	28		M	07/31/2004	Received first Anthrax shot on 18 Nov 1999. Had local reaction to vaccination, redness,swelling and pain at shot site which eventually turned hard for several weeks.  Began having fever, chills, sweats and congestion, constant fatigue and by the end of November 1999 had constant abdominal pain and nausea. A noticeable change in general health. Change in eating habits as a result of not tolerating most usual food. Constipation, with hard and darker irregular bowel movements with mucous present in stool. finally went to the Doctor in February of 2000 for symptoms. Prescribed Robitussin, Ducoulax(?), Sudafed and Allegra. Off flight status for 1 week. Received second Anthrax shot on 20 Jan 2000.  Returned to doctor on 5 APR 2000. Abdominal pain getting worse, continued constipation and irregular bowel.  Labs from February normal.  Not officially diagnosed with anything. Over the last couple years since then I have lived with constipation, abdominal pain, fatigue and have experienced increasing memory loss and inability to concentrate. In 2002, experienced recurring lower back pain, intestinal disaccharidase deficiencies and malabsorption. Unexplained acute joint and bone pain in legs and chest, Overall resulting in about 1-2 weeks of being unable to perform normal duties.				Y					N	11/18/1999	11/19/1999	1		MIL	MIL	None	None	Lactose intolerance	fever, chills, cold and flu-like symptoms~Influenza (Seasonal) (no brand name)~1~24.00~In Patient		1						1	Abdominal pain; Amnesia; Arthralgia; Back pain; Bone pain; Chills; Constipation; Disturbance in attention; Faeces discoloured; Faeces hard; Fatigue; Gastrointestinal disorder; Hyperhidrosis; Injection site erythema; Injection site pain; Injection site swelling; Nasal congestion; Nausea; Oral intake reduced; Pyrexia	ANTH~EMERGENT BIOSOLUTIONS~FAV024~1~IM~RA~ANTHRAX (BIOTHRAX)~1|DT~BSI~~2~IM~RA~DT ADSORBED (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~2~IM~LA~HEP A (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~2~IM~RA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|YF~CONNAUGHT LABORATORIES~UA11AA~1~IM~LA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0224649	08/03/2004	NV	4.0	4		M		Swelling, redness, warm to touch left arm				Y					Y	04/13/2004	04/14/2004	1		MIL	UNK		NONE				1						1	Erythema; Feeling hot; Oedema	DTAP~GLAXOSMITHKLINE BIOLOGICALS~596C9~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~765848~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~V0555~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0275N~2~IM~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0191523	08/04/2004		75.0	75		F	07/30/2004	Information has been received from a health professional concerning a 75 year old female who on 10/11/02 was vaccinated IM in the right deltoid with a dose of pneumococcal 23 polyvalent. Secondary suspect vaccinations on that same day included an IM dose in the left deltoid of influenza virus vaccine. On 10/12/02, the patient noticed a small rash on her abdomen. On 10/13/03, the sunburn-like rash extended from the back of the patient's neck to her buttocks and from both of her shoulders down to her wrists. The patient was subsequently hospitalized for three days. While hospitalized, the patient was treated with unspecified antibiotics and diphenhydramine HCl. Subsequently, the patient's ash resolved. The health professional also considered the rash to be an other important medical event (OMIC) No further information is available.					Y				Y	10/11/2002	10/12/2002	1	UNK	OTH	OTH			UNK		WAES0309USA00237	1						3	Rash	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~3	USA	Hospitalisation	Influenza
0192646	08/04/2004	VA	73.0	73		F	07/30/2004	Information has been received from a physician concerning a 73 year old female patient with no past medical history who on 10/20/02 at 2:21 PM was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (lot # 641027/1051L) (IM), in the right deltoid. Concomitant therapy that day included a second dose of influenza virus vaccine (FLUVIRIN) (IM) (lot # P35502KA), in the left deltoid. The patient at that time had also received two monthly injections of cyanobalamin (B12 injections) (previous injection was reported to be in September 2002). There was no illness at the time of vaccination. It was reported that it had been greater than five years since the first pneumococcal vaccine 23 polyvalent vaccine for the patient. On 10/20/02 the patient was feverish and her right arm was red. The patient reportedly had localized cellulitis/local redness and warmth at the right upper deltoid. The patient was treated with warm soaks, diphenhydramine HCl, cetirizine, meloxicam, and six days of cefditoren pivoxil. It was reported that the area cleared on 10/25/02. It was noted that the patient had no adverse symptoms following prior vaccinations. The physician reported that the patient recovered from the cellulitis. Additional information has been requested.				Y					Y	10/20/2002	10/20/2002	0	UNK	PVT	OTH	Cyanocobalamin		NONE		WAES0307USA01221	1						2	Cellulitis; Injection site erythema; Injection site warmth; Pyrexia	FLU3~EVANS VACCINES~~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~1051L~2~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0211760	08/04/2004	WV	42.0	42		F	07/30/2004	Information has been received from a LPN concerning a 42 year old female with a recent diagnosis of multiple sclerosis and a penicillin allergy and a past medical history of kidney stone (1985) who on approximately 28Oct03 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy that day included influenza virus vaccine (unspecified) and interferon beta1a (Avonex). Subsequently the pt developed at the inj site on right deltoid, localized swelling of upper arm 10 cm x 15cm and mild itching. The pt was afebrile. The pt was treated with diphenhydramine HC1 (Benadryl) and cool compress. It was also reported that another pt had similar symptoms. Additional information has been requested.				Y					U	10/28/2003	10/28/2003	0	UNK	OTH	OTH	Avonex		Kidney Stone, Multiple Sclerosis, Penicillin allergy		WAES0310USA03377	1						2	Injection site oedema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0740N~2~~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0211799	08/04/2004	PA	57.0	57		F	07/30/2004	Information from a physician assistant concerning a 57 year old white female with a concurrent condition of disabled who on 24Oct03 at 12:30PM was vaccinated IM in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy on the same day included influenza virus vaccine (unspecified). An illness at the time of vaccination was a UTI. On 25Oct03 at approximately 22:00, (previously reported as over the weekend), the pt developed a fever of 101.7, muscle aches, elevated blood pressure, difficulty swallowing, pounding headache, generalized weakness, lymphadenopathy, vertigo and nausea. It was noted that the pt did not go to the ER and on 27Oct03, she presented to the physicians office. Diagnostic laboratory tests were a CBC and a BMP, results not reported. The treatment of choice was ibuprofen (Advil). The pt recovered on 29Oct03. Unspecified medical attention was sought. There was no product quality complaint involved. No further information is requested.				Y					Y	10/24/2003	10/25/2003	1	body temp, 10/25/03, 101.7, complete blood cell results not reported, serum electrolytes test results not reported.	PVT	UNK		Urinary tract infection	Disability		WAES0310USA03005	1						2	Asthenia; Dysphagia; Headache; Hypertension; Lymphadenopathy; Myalgia; Nausea; Pyrexia; Vertigo	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0664N~2~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0224782	08/04/2004		75.0			M	07/30/2004	Information has been received from a registered pharmacist concerning a 75 year old male family member who in October 2002, was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. On the same day the pt was also vaccinated with a dose of influenza virus vaccine. Shortly after the injection, the pt complained of injection site sensitivity and says that the site is still sensitive. No medical attention was sought and no treatment was required. No diagnostic studies were performed. On 13AUG2003 it was reported that the pt had not recovered. No product quality complaint was involved. Additional information has been requested.									N				NONE	UNK	UNK			UNK		WAES0308USA01421	1						1	Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0224805	08/04/2004		72.0	72		M	07/30/2004	Information has been received from a physician concerning a 72 year old male patient with no known allergies with a history of immunization with a first dose of pneumococcal 23v polysaccharide vaccine in 1997 in which there was no reaction who on 9/16/03 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 645853/0256N). Concomitant therapy on 9/16/03, included influenza virus split virion 3v vaccine inactivated. Concomitant medication included levothyroxine sodium and enalapril. On 9/17/03 the patient telephoned the practice reporting that he had a swollen arm at the site of the injections, fever and chills. There was no therapy recommended. The physician spoke with the patient on the morning of 9/19/03, and the patient indicated that he is better, but not completely resolved. The reporter requested analysis of the vial or retention stock. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. The reporter indicated a similar experience with another patient. Additional information has been requested.				Y					N	09/16/2003	09/17/2003	1	UNK	OTH	OTH	Vasotec; Synthroid		Immunization		WAES0309USA02420	1						1	Chills; Injection site swelling; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0256N~2~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0224810	08/04/2004	AL	43.0	43		F	07/30/2004	Information has been received from a nurse practitioner concerning a 43 year old female clerk (same place of employment as the reporter) with seasonal allergies, an allergy to sulfa and a history of anemia, type II diabetes mellitus, hyperlipidemia, hypertension, a recent abnormal PAP test, no adverse events following prior vaccinations and no illness at the time of vaccination who on 9/30/03 at 11:00 in an outpatient clinic was vaccinated IM in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 646320/0531N). Concomitant vaccination on 6/30/03 at 11:00 included an IM dose in the right deltoid of influenza virus split virion 3v vaccine inactivated with no adverse reaction. The patient had more than 20 previous doses of influenza virus split virion 3v vaccine inactivated with no problems. Concomitant medication included simvastatin, enalapril maleate, glyburide, and loratadine. On 6/30/03 at 11:00, immediately post vaccination, the patient experienced an injection site reaction. The area became swollen as the vaccine was being instilled. The area became huge, the size of a baseball and hard. The area was localized to the deltoid. There was progressive pain, swelling and decreased range of motion in the left shoulder/arm. Ice was applied and diphenhydramine hydrochloride 25mg was given. On 10/1/03, the patient was seen with increased swelling, pain in the arm and a limited range of motion. The patient had continued to use ice on the area. No further treatment was given by the reporting nurse practitioner and the patient planned to see the physician in the clinic later that day. The patient was treated by a medical doctor with amoxicillin (+) clavulanate potassium, an NSAID and acetaminophen (+) codeine phosphate. On approximately 10/14/03 the patient recovered from the pain, swelling, and decreased range of motion. The duration was noted to be approximately 2 weeks. A product quality complaint was not involved. The reporter also mentioned a second patient that had an experience post vaccination with pneumococcal 23v polysaccharide vaccine. Additional information is not expected.				Y					Y	09/30/2003	09/30/2003	0	PAP test abnormal	OTH	OTH	Enalapril maleate; Glyburide; Claritin; Zocor		Anemia; Type II Diabetes Mellitus; Hyperlipidemia; Hypertension; Seasonal allergy; Drug hypersensitivity		WAES0310USA00243	1						1	Injection site pain; Injection site swelling; Joint range of motion decreased; Smear cervix abnormal	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0531N~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0224819	08/04/2004	IN	87.0	87		F	07/30/2004	Information has been received from a RN concerning a 87 year old female pt with no allergies and a history of high blood pressure who on 06Oct03 was vaccinated IM in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant vaccination on 06Oct03 included a IM dose in the right deltoid of influenza virus sAg 3v vaccine inactivated (FLUVIRIN). The pt did not recall if she had received vaccinations in the past. Concomitant therapy included amlodipine besylate (+) benazepril hydrochloride (Lotrel) and potassium supplementation. On 06OCt03 at approximately 20:00 (also reported as 16:00), a few hours post vaccination, the pt's left arm became sore. Later that night, the arm was warm to touch and swollen from just above the left antecubital space to about 6 inches below the shoulder. The pt had difficulty sleeping due to discomfort because the arm was achy. On 07Oct03, generalized warmth, redness and edema continued. On 07Oct03, the pt was seen in the medical office. The pt had edema of the left antecubital area to five inches below the shoulder with warmth and redness but there was no lumps on palpation, no knots or bruises. The pt was able to use her left hand and no numbness or tingling was noted. The pt stated that she felt better than the day before. Treatment was not required. On 08Oct03, the pt reported that she had taken acetaminophen (Tylenol) last pm and her arm was less swollen and less painful. Subsequently, the pt recovered. A product quality complaint was not involved. Additional information is not expected.				Y					Y	10/06/2003	10/06/2003	0	physical examination, 10/07/03, edema, warmth, redness, no lump on palpation.	OTH	PVT	Lotrel, potassium		Blood pressure high		WAES0310USA01197	1						1	Feeling hot; Insomnia; Oedema; Pain	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~6460780257N~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0224827	08/04/2004		70.0			M	07/30/2004	Information has been received from a pharmacist concerning an approximately 70 year old male (reported as 70+) who was vaccinated with dose of pneumococcal 23v polysaccharide vaccine during a flu vaccination at his pharmacy. It is thought that this dose was a revaccination. Concomitant therapy that day included as dose of influenza virus vaccine. The reporter indicated that the pt developed severe swelling and tenderness at the injection site. No other information or lot number was available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.				Y					U				UNK	UNK	UNK			UNK		WAES0310USA01556	1						1	Injection site swelling; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0224836	08/04/2004	ND	75.0	75		F	07/30/2004	Information has been received from a registered nurse concerning a retired 75 year old Caucasian female pt with allergies to Zithromax, Lodine, EES, contrast dyes, Relafen and Levaquin and NSAIDS who on 15OCT2003 at 10:30 AM was vaccinated in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. Concomitant vaccine administered on 15OCT2003 at 10:30 AM in the left deltoid included a second dose of influenza virus sAg 3v vaccine inactivated. It was noted that the pt also had her first flu vaccine last year 2002. Concomitant therapy include Toprol XL tablets 100 mg QD, Prilosec 20 mg QD PRN, Diazide 37.5/25 QD, Levoxl 0.88 mg QD, K-Dur 20 mEq QD, Dovan HCT 80/12.5 QD and Lexapro 10 mg, Diovan HCT 80/12.5 QD and Lexapro 10mg. The RN reported that on 15OCT2003 at 18:00 pm (also reported as in the afternoon of 15OCT2003, within three hours of vaccination) the pt started to develop a severe local reaction , which got worse thought the evening. The nurse reported that by the evening the right upper rm was described as swollen, hot and painful and it kept the pt awake all night. The pt used a warm pack with little relief. The nurse reported that when the pt was seen the next AM 16OCT2003 the pts arm had significant swelling with erythema of entire upper arm. The swelling and redness is from the shoulder to the elbow and the arm is tender to touch. It was noted that the pt stated, hurts so much. It was also noted there was no obvious swelling. While in the office, ice was applied to the site and the pt appeared to be feeling somewhat better. The pt's temperature was taken axillary and oral as 98.9 degrees F. The following lab tests were done and the results reported as follows: PT-10.8, INR 1.07, CBC all normal except HgB 11.9, Hct 36.8, MPV 8.6 all were slightly low). Platelets 170x 10 3U/L. the nurse reported she did not know whether the pt took anything for discomfort. In follow up information it was noted that the pt was instructed to ice her arm, take Benadryl and she was given prescriptions for lorazepam 0.5 1/2 tablet every 6 hours as needed, and Darvocet for pain. It was noted that the pt believed, this was her fist dose of pneumococcal 23v polysaccharide vaccine ever. The nurse also reported that the patient had a lesser, but similar reaction to the influenza virus sAg 3v vaccine inactivated this year (administered 15OCT2003 in the left deltoid) and to the first dose of influenza virus vaccine in 2002. The reactions to the influenza virus in 2002 were reported as mild rxns, ecchymotic with lump on right arm (also reported as black and blue at the injection site with tenderness). The RN reported that as of 17OCT2003 the pt was improved, and as of 04NOV2003 the pt only had slight itch in upper arm. The pt had no illness at the time of vaccination. There was no other date at this time. There was no product quality complaint involved. Additional follow up received from the registered nurse confirmed the pt recovered and that the pt has had no problems since 17OCT 2003. Unspecified medical attention was sought. No additional information is expected.				Y					Y	10/15/2003	10/15/2003	0	10/16/2003: INR1.07, Hemoglobin 11.9 sl low, platelet count 17000 3u/L, height 66 inches , weight 160, mean platelet vol 8.6 sl low, tempt 98 degrees axillary and oral, hematocrit 36.8 sl low.	PVT	PVT	Lexapro , Diazide, Diovan HCT, Levoxul, Toprol XL Tablets, Prilosec, K-Dur		Multiple allergies	ecchymosis, nodule, injection site tenderness~Influenza (Seasonal) (no brand name)~1~0.00~In Patient	WAES0310USA02048	1						1	Erythema; Feeling hot; Laboratory test abnormal; Pain; Pruritus; Swelling; Tenderness; Vaccine positive rechallenge	FLU3~EVANS VACCINES~~2~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0709M~1~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0224854	08/04/2004		68.0			F	07/30/2004	Information has been received from a nurse practitioner concerning a female patient between the age of 68 and 78 years old who on 10/17/03 at a flu clinic was revaccinated in the arm with a dose of pneumococcal 23v polysaccharide vaccine (lot # 646159/0287N). Concomitant vaccine therapy included a normal adult dose of influenza virus vaccine. Subsequently, within hours of the vaccination, the patient developed redness, swelling and pain at the injection site in the arm where the pneumococcal 23v polysaccharide vaccine had been given. The patient was treated in the emergency room with IV ceftriaxone sodium. The patient was later seen by her own physician and has since recovered. It was also reported that the patient thought that it had been more than 5 years since she was vaccinated, however, it was reported that in November 2002 she had been vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. No product quality complaint was involved. Upon internal review, redness, swelling, and pain at the injection site were determined to be other important medical events (OMIC). It was also reported that three other female patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 646159/0287N) and also developed redness, swelling and pain at the injection site. Additional information has been requested.				Y					Y	10/17/2003	10/17/2003	0	UNK	OTH	OTH			UNK		WAES0310USA03020	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0224857	08/04/2004					F	07/30/2004	Information has been received from a pharmacist concerning a female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The reporter indicated that two weeks prior to vaccination, the pt was vaccinated with the flu vaccine. The pt developed cellulitis the next day after vaccination with pneumococcal 23v polysaccharide vaccine. The pt was treated with PO Keflex and completely recovered within 24 hours. The reporter did not know if pneumococcal 23v polysaccharide vaccine was given in the same arm that the pt received the flu vaccine. There was no product quality complaint involved.  The pharmacist also reported additional pts who had similar experiences following exposure to pneumococcal 23v polysaccharide vaccine. Additional info has been requested.				Y					Y					UNK	UNK			UNK		WAES0310USA03142	1						1	Cellulitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~2~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0224861	08/04/2004	TX	70.0	70		F	07/30/2004	Information has been received form a licensed visiting nurse concerning a 70 year old Caucasian female with a medical hx of an allergy to sulfa drugs and osteoporosis who on 27OCT2003 at 14:00 was vaccinated IM in the right deltoid with a first dose of pneumococcal vaccine 23 polyvalent. concomitant therapy on 27 OCT 2003 at 14:00 included an IM dose in the left deltoid of influenza virus whole virion 3v vaccine inactivated. Other concomitant medications included Actonel, Omnicef for headache, possible sinus problem and Rhinocort. Illnesses at the time of vaccination were sinus pressure and headache with no temperature. On 27OCT2003, in the evening (previously reported as 28OCT2003) when the pt left the office, 20 minutes after the injection, she reported that she had no adverse rxns and that the site was healthy, however, the pt reported her am begain swelling later that day. On 28OCT2003, she developed pain redness and swelling to the area below the deltoid muscle (previouisly described as swelling of right arm, 2-3 inches below the injection site and a 4-5 inche wide in band with raised, red, welt and mild flu like symptoms, described as body aches and a low grade temperature). It was noted that on 29OCT2003, on examination she had a sleeve below deltoid muscle with demarcation noted that on 29OCT2003, on examination she had a sleeve below deltoid muscle with demarcation line inferiorly. There was diffuse erythema and mild edema over medial aspect of upper arm. There was no tenderness to the deltoid muscle and the pt reproted decreased pain. It was noted that treatment was not known at this time. It was also noted that the duration was 4-5 days and the pt recovered on approximately 01NOV2003. Unspecified medical attention was sought. There was no product quality complaint involved. No further information is expected.				Y					U	10/27/2003	10/27/2003	0	body height: 64 inches. body temp 10/28/03: low grade temperature. body weight measurement: 133 lbs	PVT	PVT	Rhinocort Aqua, Omnicef, Actonel	Headache, Sinus pressure	Drug hypersensitivity, Osteoporosis		WAES0310USA03197	1						1	Erythema; Influenza like illness; Oedema; Pain; Pyrexia; Rash erythematous; Swelling; Urticaria	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1079M~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0224863	08/04/2004	LA	66.0	66		F	07/30/2004	Information has been received from a LPN concerning a retired 66 year old white female with non insulin dependent diabetes mellit8s, hyperlipidemia, high cholesterol, hypertension, an  allergy to Bactrim and sulfa meds and Dx 250.00, 272.0, 401.9 who on 16OCT1998 was vaccinated with a first dose of pneumococcal vaccine 23 polysaccharide vaccine and on 29OCT2003 at 10:45am was vaccinated IM in the right deltoid with a second dose of pneumococcal vaccine 23 polysaccharide vaccine. The pt reported that she was not sure if this was her second or third dose of pneumococcal vaccine 23 polysaccharide vaccine.  In the am, on 29OCT2003 the pt was also vaccinated in the left arm with a dose of Fluvirin. Other concomitant therapy included Glucophage, Lipitor and Zestril. The pt returned to the physician's office at 14:45 with a local rxn described as swelling about 3 inches in diameter, with slight redness, warmth and tenderness.  There was no fever. The pt was prescribed Benadryl and Zyrtec. On 01NOV2003 the pt recovered. A product quality complaint was not involved. Follow up information was received from the LPN which indicated that on 29OCT2003, in the pm, the pt developed redness, swelling and warmth at the injection site. It was reported that the pt recovered on 05NOV2003. No additional information is expected.				Y					Y	10/29/2003	10/29/2003	0	height 58.5 inches, temp 10/29/03: afebrile, weight: 159	PVT	PVT	Lipitor, Zestril, Glucophage		Drug hypersensitivity, Diabetes mellitus non insulin dependent, Cholesterol high, Hypertension, Hyperlipidemia.		WAES0310USA03214	1						1	Injection site erythema; Injection site swelling; Injection site warmth; Tenderness	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0864N~2~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0224864	08/04/2004	MO	60.0	60		F	07/30/2004	Information has been received from a pharmacist concerning a 60 year old female patient with a medical history of an allergy to penicillin and neomycin and a small benign brain tumor who was part of a group of 24 reported reactions out of 200 vaccinated employees and was vaccinated in the left arm during the first week of October, 2003 (also reported as October 2003) with a first dose of pneumococcal 23v polysaccharide vaccine (lot number 643784/0676M). Concomitant therapy during the first week of October 2003 (also reported as October 2003) included influenza virus vaccine (unspecified). The patient was not taking any prescription drugs at the time she received the vaccinations. It was noted that both vaccines were administered only minutes apart and that the patient received both vaccines in the same arm at her request. During the first week of October 2003 (also reported as October 2003) almost immediately, the patient developed an adverse reaction described as a fever and her left arm turned red, began to swell, and became extremely warm and painful (also reported as redness up and down the arm, swelling, warmth, pain, knot at site and still had warmth in knot and a knot in elbow which was very painful by the end of the day and had difficulty using it). Other complaints were sore throat, nausea, vomiting, diarrhea and aches all over. A couple of days later, she went to an emergency department of a hospital and was diagnosed with cellulitis. The patient was given a prescription for cephaloridine (Cefalexin). It was also noted that the patient went to her doctor and was diagnosed with cellulitis. The patient noted that even though it had been more than one month since she received these vaccines, some symptoms still persist. She mentioned that the discomfort had progressed down her arm to the area of her elbow and that she still had discomfort and redness in her left elbow. It was noted that many spent the entire weekend in bed after being vaccinated on a Friday. The patient reported that she had missed 3 and a half days from work due to this. The pharmacist suggested Ibuprofen or acetaminophen for the symptoms and to follow up with their physicians. The reporter expressed concern about the particular lot of vaccine and mentioned that the patient's were vaccinated all from lot # 0676M. The patient indicated that she was seeking reimbursement for some of her expenses, such as lost time from work, which resulted from the adverse experience. The patient reported that the site had improved, however she did still have a small amount of swelling in her left elbow. There was no product quality complaint involved. Follow up information indicated that the reporter did not have more information to add to the reports as she did not speak directly to any of the 24 patients in this case. Upon internal review, cellulitis was considered an other important medical event (OMIC). The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. The reporter also mentioned two other patients and 21 patients who were part of the 24 reported reactions and were vaccinated with pneumococcal 23v polysaccharide vaccine (lot # 643784/0676M). Additional information has been requested.				Y					N	10/01/2003	10/01/2003	0	body temp: fever	OTH	OTH			Drug hypersensitivity; Brain neoplasm benign		WAES0310USA03223	1						1	Cellulitis; Diarrhoea; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Nausea; Pain; Pharyngolaryngeal pain; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0676M~1~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0224865	08/04/2004					F	07/30/2004	Information has been received from a pharmacist concerning a female patient who was part of a group of 24 reported reactions out of 200 vaccinated employees and was vaccinated during the first week of October, 2003 wit a dose dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy during the first week of October, 2003, included influenza virus vaccine. It was noted that all of them received both vaccines in the same arm at their request. The patient developed inflamed lymph nodes. Other complaints were sore throat, nausea, vomiting, diarrhea and aches all over. It was noted that many spent the entire weekend in bed after being vaccinated on a Friday and some missed work for a few says after that. The pharmacist suggest Ibuprofen or Tylenol for the symptoms and to follow up with their physicians. The reporter expressed concern about the particular lot of vaccine and mentioned that the patients were vaccinated all from Lot 0676M. Unspecified medical treatment was sought. There was no products quality complaint involved. Follow up information indicated that the reporter did not have more information to add to the reports as she did not speak directly to any of the 24 patients in this case. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned two other patient and 21 patient who were parts of the 24 reported  reactions and were vaccinated with dose of pneumococcal 23v polysaccharide vaccine.				Y					U	10/01/2003			UNK	UNK	UNK			UNK		WAES0310USA003224	1						1	Diarrhoea; Lymphadenitis; Nausea; Pain; Pharyngolaryngeal pain; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0676M~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0224866	08/04/2004					U	07/30/2004	Information has been received from a pharmacist concerning a patient who was part of a group of 24 reported reactions out of 200 vaccinated employees and was vaccinated during the first week of October, 2003 with a dose dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy during the first week of October, 2003, included influenza virus vaccine. It was noted that all of them received both vaccines in the same arm at their request.  The patient had trouble breathing. Other complaints were sore throat, nausea, vomiting, diarrhea and aches all over. It was noted that many spent the entire weekend in bed after being vaccinated on a Friday and some missed work for a few days after that. The pharmacist suggested Ibuprofen or Tylenol for the symptoms and to follow up with their physicians. The reporter expressed concern about the particular lot of vaccine and mentioned that the patients were vaccinated all from Lot 0676M. Unspecified medical treatment was sought. There was no product quality complaint involved. Follow information indicated that the reporter did not have more information to add to the reports as she did not speak directly to any of the 24 patients in this case. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned two other patient and 21 patient who were parts of the 24 reported reactions and were vaccinated with dose of pneumococcal 23v polysaccharide. Additional information has been requested.				Y					U	10/01/2003	10/01/2003	0	UNK	UNK	UNK			UNK		WAES0310USA03225	1						1	Diarrhoea; Dyspnoea; Nausea; Pain; Pharyngolaryngeal pain; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0676M~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0224869	08/04/2004	NJ	5.0	5		M	07/30/2004	Information has been received from an RN concerning a 5 year old white male pt with a medical hx of an allergy to mite dust, allergic rhino sinusitis , chronic otitis media with effusion and asthma who on 27OCT2003 at 15:30 was vaccinated IM in he left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy on 27OCT2003 at 15:30 included an IM first dose in the right deltoid of influenza virus split virion 3v vaccine inactivated. Other concomitant medication were fluticasone propionate + salmeterol xinafoate 100/50 BID. On 29SEP2003 a dose of pneumococcal vaccine (Prevnar) as administered at a different office. The pt's mother reported the patient was very restless for 2 hours with vaccination of PCV7 on 29SEP2003. On October 27, 2003, between 17:30 and 18:30, the patient complained of pain at the left arm injection site and had a fever about 3 hours after vaccination. On 28OCT2003, the pt developed a T104 degrees, was shaking, lethargic, complained of a frontal headache and a painful left arm. On 29OCT2003, the patient vomited once described as large amount of phlegm, temperature at 13:30 and 105.4, it was noted again that the pt complained of frontal headache and his left arm was red and swollen. On 30OCT2003, the fever and headache were decreased and the left arm was swollen, red and painful. On 01NOV2003, the left arm was still sore and the fever and headache were gone. No treatment was required for the symptoms, however it was noted that the pt was using ibuprofen (Motrin) prn and cool compresses locally to the left arm. It was noted that on 12NOV2003, the pt had recovered, however, it was also noted on 12NOV2003, only the left arm was a little tender. Unspecified medical attention was sought. There was no product quality complaint was involved. Follow up information revealed at the pt office visit on 20DEC2003, the tenderness at the left arm was one and the pt had recovered. It was noted that there were no further symptoms. No further information is expected.				Y					Y	10/27/2003	10/27/2003	0	105.4F:10/29/2003. 104F: 10/27/2003.	PVT	PVT	Advair		Asthma, House dust mite allergy, Allergic sinusitis, Otitis media chronic		WAES0310USA03335	1						1	Erythema; Headache; Injection site pain; Lethargy; Pyrexia; Restlessness; Swelling; Tenderness; Tremor	FLU3~SANOFI PASTEUR~~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0676M~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0224870	08/04/2004	MD				M	07/30/2004	Information has been received form a human resources department employee concerning a male pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant vaccination at the same time included a dose of influenza virus vaccine. Subsequently, the pt reported getting sick and feeling bad. The patient felt so bad after the shots that he went to bed. At the time of the report, the pt was back at work and was feeling better. A product quality complaint was not involved. The human resources department employee mentioned this pt was one of more than 25 pts who had similar experiences post vaccination with pneumococcal 23v polysaccharide. Followup information was received from the administering nurse. The nurse noted that this population was needy and that many of the pts had long histories of being incarcerated. According to the nurse, none of the patients were bed ridden. The nurse described the patients' reported experiences as flu like symptoms. Subsequently, the patients all recovered an none of them required treatment. Additional information is not expected.									Y				UNK	UNK	UNK			Incarceration		WAES0310USA03345	1						1	Influenza like illness; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0224882	08/04/2004	WI	83.0			F	07/30/2004	Information has been received from an RN concerning an 83 year old female with allergies to sulfa and iodine and no other medical hx who on 30OCT2003 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine. Concomitant vaccination in the other arm included a dose of influenza virus vaccine. Concomitant medication included aspirin. The reporter indicated that the pt developed a reddened area around the injection site with edema. No treatment was required for the event. The reporter also noted that she was concerned about the lot number and has pulled the remaining vials in this lot from the stock. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned that two other female pts had similar reactions after therapy with  pneumococcal 23v polysaccharide vaccine and experience a similar reaction. Additional info has been requested.									U	10/30/2003	10/30/2003	0	unk	UNK	UNK	Aspirin		hypersensitivity, iodine allergy			1						1	Injection site erythema; Injection site oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0772N~2~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0224883	08/04/2004	WI	43.0			F	07/30/2004	Information has been received from an RN concerning an 43 year old female with no medical hx or allergies who on 30OCT2003 was vaccinated with a first dose of pneumococcal 23 v polysaccharide vaccine. Concomitant vaccination in the other arm included a dose of influenza virus vaccine. There was no other concomitant medication. The reporter indicated that the pt developed a reddened area around the injection site with edema. No treatment was required for the event. The reporter also noted that she was concerned abut the lot number and has pulled the remaining vials in this lot form the stock.  The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned that two other female pts had similar rxns after therapy with pneumococcal 23v polysaccharide vaccine. Additional info has been requested.									U	10/30/2003	10/30/2003	0	IML	UNK	UNK			NONE		WAES0311USA00449	1						1	Injection site erythema; Injection site oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0772N~1~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0224886	08/04/2004		68.0			F	07/30/2004	Information has been received from a nurse practitioner concerning a female patient between the age of 68 and 78 years old who on 10/17/03 at a flu clinic was revaccinated in the arm with a dose of pneumococcal 23v polysaccharide vaccine (lot # 646159/0287N). Concomitant vaccine therapy included a normal adult dose of influenza virus vaccine. Subsequently, within hours of the vaccination, the patient developed redness, swelling and pain at the injection site in the arm where the pneumococcal 23v polysaccharide vaccine had been given. The patient was treated in the emergency room with IV ceftriaxone sodium. The patient was later seen by her own physician and has since recovered. It was also reported that the patient thought that it had been more than 5 years since she was vaccinated, however, it was also reported that in January 2001 she had been vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. No product quality complaint was involved. Upon internal review, redness, swelling and pain at the injection site were determined to be other important medical events (OMIC). It was also reported that three other female patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 646159/0287N) and also developed redness, swelling and pain at the injection site. Additional information has been requested.				Y					Y	10/17/2003	10/17/2003	0	UNK	OTH	OTH			UNK		WAES0311USA00634	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0287N~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0210601	08/05/2004	CA	50.0	50		F	07/30/2004	Information has been received from a 50 year old female pt who on 08OCT2003 was vaccinated in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant vaccine therapy administered on 08OCT2003 included a dose of influenza virus split virion 3v vaccine inactivated. The pt reported she had an allergic reaction to the shot She noted that her physician feels that it was probably a reaction to a preservative in the vaccine. The pt reported that the allergic rxn was not life threatening. The pt also reported she has not had an adverse event to another vaccine, and she did not have a cold, fever or acute illness at the time of vaccination. Additional information received from the pt reported she received the vaccine at a Drugstore, she indicated it was not prescribed by a physician. she also noted, she did not see doctor after reaction, saw, RN. Unspecified medical attention was sought. No additional information is expected.				Y					U	10/08/2003			UNK	UNK	UNK			UNK		WAES0312USA02180	1						2	Hypersensitivity	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0257N~UNK~~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0212922	08/05/2004	OR	66.0	66		F	07/30/2004	Information has been received from a RN concerning a 66 year old female with no significant medical history and no known drug allergies who on 11/15/03 at 13:25 was vaccinated IM in the right deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (Lot #646159/0287N). Concomitant vaccine therapy given IM in the right deltoid included a dose of influenza virus split virion 3v vaccine inactivated (Fluzone)(batch #76566).  There was no illness at the time of vaccination. On 11/18/03 at 14:30 the pt developed a local reaction described as a red and swollen right tricep area. There was no cellulitis. Unspecified medical attention was sought and the pt was to be given cephalexin (Keflex) if the symptoms worsened. It was noted that the exact date of the first administration of pneumococcal 23v polysaccharide vaccine was unknown. No product quality complaint was involved. Follow up information reported that the pt did not take the prescribed antibiotics and recovered. It was also reported that another female pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot #646159/0287N) and developed injection site cellulitis (WAES #0311USA02521).  Additional information is not expected.				Y					Y	11/15/2003	11/18/2003	3	UNK	OTH	PVT	UNK	UNK	NONE		WAES0311USA02248	1						2	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0287N~2~IM~UN~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0212923	08/05/2004	OR	23.0	23		F	07/30/2004	Information has been received from a RN concerning a 23 year old female pt with asplenia and no past medical history of any allergies who on 19Nov03 at 1643 was vaccinated IM in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. On 16Nov03 at 1643 with a dose of influenza virus split virion 3v vaccine inactivated. Concomitant medication included birth control pills. On 16Nov03 at 2030 the pt developed a cellulitis at the injection site of the arm that was vaccinated with the pneumococcal 23v polysaccharide vaccine. The pt was diagnosed with a cellulitis of the left arm. Unspecified medical attention was sought and the pt was treated with oral cephalexin and then changed to gatifloxacin for the cellulitis. Subsequently, the pt recovered. A product quality complaint was involved. Upon internal review, cellulitis of the left arm was determined to be an other important medical event. It was also reported that another female pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed injection site redness and swelling. No further information is expected.				Y					Y	11/16/2003	11/16/2003	0	UNK	UNK	UNK	Hormonal contraceptives		Asplenia		WAES0311USA02521	1						2	Cellulitis	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0287N~1~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0213518	08/05/2004	NC	28.0	28		F	07/30/2004	Information has been received form an RN concerning a 28 year old white female with no allergies or medical hx who on 19NOV2003, at 11:30 am, was vaccinated IM in the right deltoid with a first dose of pneumococcal vaccine 23 polyvalent vaccine. Concomitant vaccine at 11:30 am included a dose IM in the left deltoid of influenza virus vaccine: Fluvarin. There was no illness at the time of vaccination. Subsequently, the pt developed moderate to severe soreness, erythema, swelling and low grade fever. It was noted that both pts received doses from the same vial but  the lot number was not available. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information indicated that on 19NOV2003 at 20:00 the pt had increasing soreness at the injection site and felt fatigued. Her right upper arm was red and blotchy and she was swollen form the shoulder to the elbow. The next day she was unable to raise the right arm. No labs or diagnostic tests were done. She recovered in approximately 2-3 days. The reporter also mentioned another pt who experienced a similar rxn. Additional information is not expected.				Y					Y	11/19/2003	11/19/2003	0	temp: low grade fever 11/19/03	PVT	PVT			NONE		WAES0312USA00415	1						2	Erythema; Fatigue; Injection site reaction; Joint range of motion decreased; Pyrexia; Rash macular; Swelling; Tenderness	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~0947N~1~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0224920	08/05/2004	MO	48.0			F	07/30/2004	Information has been received from a LPN concerning a 48 year old female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 646159/0287N). Concomitant vaccine therapy in the opposite arm included a dose of influenza virus vaccine (unspecified). About 6-8 hours post-vaccination the pt developed an injection site reaction with upper arm soreness and swelling. Unspecified medical attention was sought. No other information was provided. No product quality complaint was involved. It was also reported that another pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 646159/0287N) and developed an injection site reaction (WAES #0311USA01000).  Additional information has been requested.				Y					U				UNK	OTH	OTH	UNK	UNK	UNK		WAES0311USA00849	1						1	Injection site oedema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0287N~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0224924	08/05/2004	MO	60.0			F	07/30/2004	Information has been received from a LPN concerning a female in her late 60's who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 646159-0287N). Concomitant vaccine therapy in the opposite arm included a dose of influenza virus vaccine (unspecified). About 6-8 hours post-vaccination the pt developed an injection site reaction with upper arm soreness, and swelling. It was also reported that the pt developed cellulitis. Unspecified medical attention was sought. No other information was provided. No product quality complaint was involved. It was also reported that another pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 646156/0287N) and developed an injection site reaction (WAES # 0311USA00849).  Additional information has been requested.				Y					U				UNK	OTH	OTH	UNK	UNK	UNK		WAES0311USA01000	1						1	Cellulitis; Injection site oedema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0287N~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0224931	08/05/2004	PA		74		F	07/30/2004	Information has been received from a health professional concerning a female who on 10/31/03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 645646/0068N). This was a revaccination with pneumococcal 23v polysaccharide vaccine. Concomitant therapy that day included a dose of influenza virus vaccine (Unspecified). Subsequently the pt developed local redness, swelling, and pain. The pt went to the ER, but was not admitted to the hospital. No additional information was provided. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.				Y					U	10/31/2003			UNK	OTH	OTH	UNK	UNK	UNK		WAES0311USA01542	1						1	Injection site erythema; Injection site oedema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0068N~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0224948	08/05/2004	IA	60.0	60		F	07/30/2004	Information has been received from a licensed practical nurse concerning a 60 year old white female with pollen allergies, hypertension, and hyperthyroidism who on 11/18/03 in the AM was vaccinated IM in the right deltoid with a third dose of pneumococcal 23v polysaccharide vaccine (lot # 644217/1026M). Concomitant vaccination on the same day in the AM included a fifth dose in the left deltoid of influenza virus split virion 3v vaccine inactivated  (FLUZONE) (lot # U1136AA). There was no illness at the time of vaccination. Subsequently the patient developed redness, swelling and pain at the injection site. The patient was treated for the symptoms with over the counter acetaminophen, diphenhydramine hydrochloride, and ice. Unspecified medical attention was sought and it was noted that a prescription drug was required. A product quality complaint was not involved. Follow up information received from the licensed practical nurse which indicated that in the AM on 11/18/03, the patient developed redness and swelling instantly after receiving pneumococcal 23v polysaccharide vaccine in the right deltoid. Ice was applied and the patient was told to take diphenhydramine hydrochloride and acetaminophen every four hours. The nurse talked to the patient two days later and the swelling had gone to her elbow. The patient recovered on 11/25/03. Additional information has been requested.				Y					Y	11/18/2003	11/18/2003	0	UNK	PVT	PVT			Pollen allergy; Hypertension; Hyperthyroidism		WAES0311USA02740	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1136AA~5~~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1026M~3~IM~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0224954	08/05/2004	AR	72.0	72		F	07/30/2004	Information has been received from an RN concerning a 72 year old white female pt with hypertension, diabetes, and a hx of irritable bowel syndrome, obesity and previous vaccination with dose of pneumococcal 23v polysaccharide vaccine in 1996, who on 24NOV2004 was vaccinated IM in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine.  Other therapy administered on 24NOV2003 included a dose of influenza virus vaccine. Concomitant therapy included Lipitor, Xanax, Bentyl, Anafranil and Avandia. The registered nurse reported that the pt developed a local site reaction described as redness, swelling, pain and splotchiness on the arm. It was noted the pain at the site radiated to her neck. The reporter noted that on 25NOV2003 the symptoms were getting worse and were being treated with Benadryl and soma. Unspecified medical attention was sought. There was no product quality complaint reported. Additional information received from the RN reported the pt recovered. Additional information is not expected. The registered nurse also mentioned that three other pts experienced similar site reactions: redness, swelling, pain and splotchiness following vaccination with dose of pneumococcal 23v polysaccharide vaccine.				Y					Y	11/24/2003	11/24/2003	0	UNK	PVT	PVT	Xanax, atenolol, Lipitor, Anafranil, Bentyl, glipizide, Avandia		Immunization, Irritable bowel syndrome, Obesity, Hypertension, Diabetes		WAES0312USA00033	1						1	Injection site erythema; Injection site pain; Injection site swelling; Rash maculo-papular	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0287~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0224960	08/05/2004	OK	34.0	34		F	07/30/2004	Information has been received from a physician concerning a 34 year old female American Indian pt in marketing with hypothyroidism who on 05NOV2003 was vaccinated in the left deltoid with a second IM 0.5 ml dose of pneumococcal 23v polysaccharide vaccine . Concomitant vaccinations on 05NOV2003 included a second IM dose in the R deltoid of influenza virus. Concomitant therapy included replacement for hypothyroidism. There was no illness at the time of vaccination. Upon receiving the vaccine on 05NOV2003, the pt developed asthenia, malaise, body aches, subjective fever and a local reaction around the injection site., which progressed to swelling, edema, pain, redness/ erythema and +/- hyperemia. The pt went to the ER, but treatment was not required and laboratory tests were not performed. The local rxn resolved in a few days with, but the asthenia and malaise were still present three weeks later. On 25NOV2003,the he pt was documented as recovered. It was noted that the experience resolved with time and local measures. A product quality complaint was not involved. Additional info is not expected.				Y					Y	11/05/2003	11/05/2003	0	NONE	UNK	PVT	Thyroid		Hyperthyroidism		WAES0312USA00421	1						1	Asthenia; Erythema; Hyperaemia; Injection site reaction; Malaise; Oedema; Pain; Pyrexia; Swelling	FLUX~UNKNOWN MANUFACTURER~~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0604N~2~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0224971	08/05/2004	VA	61.0			M	07/30/2004	Information has been received from a 61 year old male pt with no known allergies who in December 2002 and on 12/04/03 at 13:20 was vaccinated in the right deltoid with a first and second dose of pneumococcal 23v polysaccharide vaccine, respectively (Lot #: second dose 646322/0530N). It was noted that the pt inquired as to a possible overdose. There was no illness at the time of vaccination. It was noted that the HCP'S at the office were not aware that he received the vaccine last year. Concomitant therapy included a dose influenza vaccine in the left deltoid. Concomitant medication included Lipitor, bisoprolol and aspirin 81mg. On 12/05/03, he stated his site is swollen, red and very painful and he cannot raise his right arm. A prescription drug was not required. There were no diagnostic lab tests performed. Unspecified medical attention was sought. It was noted initially that the pt had not recovered; however subsequent recovery status was reported as unknown by another reporter. There was no product quality complaint involved. Follow up information from a health care professional indicated that the pt did not contact the MD's office with any adverse reactions. The pt requested 'Pneumovax' and after receiving it, he asked when he should get another one as he received a vaccine in 2002 also. No further information is available.				Y					N	12/04/2003	12/04/2003	0	NONE	PVT	PVT	Aspirin; Lipitor; Bisoprolol;	NONE	UNK		WAES0312USA00811	1						1	Hypokinesia; Injection site erythema; Injection site oedema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0530N~2~~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0224977	08/05/2004	MA	46.0	46		F	07/30/2004	Information has been received from a consumer and a physician concerning a 46 year old white female pt with no allergies and a history of renal stones, appendectomy and hysterectomy who on 11/14/03 was vaccinated IM in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (Lot # 647028/0564N). Concomitant vaccination on 11/14/03 included an IM dose in the left deltoid of influenza virus split virion 3v vaccine inactivated (Fluzone)(Lot # U1058AA).  There was no illness at the time of vaccination and there were no adverse events following prior vaccination. On 11/15/03, the pt developed a very large red area surrounding the site, a headache and a low grade fever. It was also reported that the pt developed a local reaction and was swollen from the elbow to the shoulder. Medical attention was sought and the pt was treated with Benadryl and Zantac. Lab tests were not performed. It was noted that therapy with pneumococcal 23v polysaccharide vaccine was discontinued. On 11/21/03, the pt recovered from the red area, headache and fever. A product quality complaint was not involved. The reporters also mentioned two other pt's who experienced local reactions following vaccination with pneumococcal 23v polysaccharide vaccine (Lot # 647028/0564N)(WAES#0311USA01984 & 0401USA00073).  Additional information is not expected.				Y					Y	11/14/2003	11/15/2003	1	NONE	PVT	PVT	UNK	UNK	Kidney stone; Appendicectomy; Hysterectomy;		WAES0312USA01176	1						1	Headache; Injection site erythema; Injection site oedema; Pyrexia	FLU3~SANOFI PASTEUR~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0564N~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0224987	08/05/2004	PA				U	07/30/2004	Information has been received from a LPN concerning a pt who on an unspecified date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647359/0740N). Other therapy administered on that same day included a dose of influenza virus vaccine (unspecified). The LPN reported that the pt developed cellulitis. The LPN reported the don't know which vaccine caused it.  It was noted the pt required an oral antibiotic for treatment. It was noted the pt was not hospitalized. No other information was provided. There was no product quality complaint involved. The pt sought unspecified medical attention.  Upon internal review cellulitis was determined to be an other important medical event (OMIC). No additional information is expected. The reporter also indicated that another 3 pt's developed injection site reactions consisting of redness, swelling and itching; and another 2 pt's developed severe cellulitis-like reactions following vaccination with pneumococcal 23v polysaccharide vaccine (Lot # 647359/0740N).				Y					U				UNK	OTH	OTH			UNK		WAES0312USA02190	1						1	Cellulitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0740N~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0225001	08/05/2004	NY	44.0	44		M	07/30/2004	Information has been received from a healthcare worker and an LPN concerning a 44 year old Caucasian male pt who on 30DEC2003 was vaccinated in the left arm with a first dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included a dose of influenza virus vaccine and immuno-supressive medications. On 31DEC2003, the pt called the medical office with complaints of tenderness and swelling at the injection site. An onset time of 13:33 on 31DEC2003 was noted. The pt's experience was also described as a severe local rxn that included swelling and soreness. There was no erythema, no fever or chills. Unspecified medical attention was sought. A product quality complaint was not involved. The reporter also mentioned two female pts who had similar local reactions post vaccination with pneumococcal 23v polysaccharide vaccine. Additional info is not expected.				Y					Y	12/30/2003	12/31/2003	1	UNK	PVT	PVT					WAES0401USA00247	1						1	Immune system disorder; Injection site swelling; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0944N~1~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0225040	08/05/2004	CA	33.0	33		F	08/05/2004	This 34-year-old was activated November 2003 and later discharged.  During this month of activation, she received Anthrax #1, Typhoid, Hepatitis A #1, Influenza, IPV, Diphtheria, and a Tuberculin test.   She states the shot was given to the upper backside of her right arm.  That evening her arm became swollen, puffy and itched. She did complete physical training before and the morning after receiving her immunizations. She remembers having flu-like symptoms including a fever (unknown elevation), body aches, chills and a bad cold that she sought medical care for.  She states medical personnel advised her that her cell count was down possibly due to the number of shots given. Approximately one week later, she noticed an itchy facial rash that began on her forehead spreading to her cheeks, chin and neck, as if she had the measles or chicken-pox.  Approximately two weeks after immunization this rash now included both forearms.  There was no rash to her trunk or lower extremities.  She describes the rash as a reddened area covering her skin with scattered pimples  some with depressed centers and others with pus-like centers.  She states the rash comes and goes lasting for 3-4 days, resolved for approximately one week and then returning to the same areas.  This rash does itch and appears located to areas of skin that are not covered by clothing.  She is concerned about a reoccurring pea-sized bump that comes and goes at her immunization site.  This bump coincides with the rash.  Furthermore, she is concerned over the scaring these rashes are leaving on her skin.  She reports the scaring as a darkening pigmentation. She has treated the rash with Aveno skin toner and alcohol washes to try and dry up the rash without success.  She denies any lymphadenopathy, nausea, vomiting, abdominal pain, joint-muscular weakness or pain, or any history of skin disease.  She has not seen any medical personnel for this skin rash, prior to or since her discharge.				Y					U	11/19/2003	11/19/2003	0	pending MD exam 8/5/04	UNK	UNK						1						1	Chills; Erythema; Influenza; Injection site mass; Oedema peripheral; Pain; Pharyngitis; Pruritus; Pyrexia; Rash maculo-papular; Rash pruritic; Rhinitis; Skin discolouration	ANTH~MICHIGAN DEPT PUB HLTH~~1~~RA~ANTHRAX (NO BRAND NAME)~1|DT~BSI~~1~~UN~DT ADSORBED (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~1~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~1~~UN~HEP A (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0225059	08/06/2004	WA	56.0	56		F	07/21/2004	Hives. Pt called us, and doctor, both counseled her to take Benadryl . Later, pt came in with rxn for prescriptions for Benadryl 50 mg and Prednisone 20 mg from ER at 11:00 on 10/01/2003				Y					Y	09/29/2003	10/01/2003	2	NONE	UNK	PVT	Premarin, Protonix, Lipitor	NONE			WA042045	1						1	Urticaria	FLU3~SANOFI PASTEUR~U1256AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0225477	08/17/2004	PR				F		Abrupt onset of macular and elevated multiform lesions with erythema swelling of ears, lips and eyelids. Tx with epinephrine, solumedral and Benadryl									Y	04/29/2004	04/29/2004	0		PUB	UNK					PR0403	1						1	Erythema; Eyelid oedema; Face oedema; Rash macular	FLU3~SANOFI PASTEUR~U1108AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0225478	08/17/2004	PR	68.0	68		F	06/30/2004	Left arm vesicles, papules, anted  (aggregated) lesions with pruritus, erythema and edema of arm. Also severe pain at arm Tx: Allegra 60mg BID/ Bactroban/ Diprolene				Y					N	06/15/2004	06/16/2004	1		PUB	PUB	Cetenolol 25mg	NONE	Penicillin (Allegra) KDP		PR0404	1						1	Blister; Erythema; Oedema; Pain; Pruritus; Rash papular	FLU3~SANOFI PASTEUR~U1269AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0685N~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0225543	08/18/2004	MA	42.0	41		F	07/19/2004	Felt sick, nausea, fatigue within the week and felt like fainting-symptoms progressed after that-very fatigued dizziness, nausea-hospitalized in Dec and seeking treatment since. Discharge summary states headache. msv Per the follow up report-dizziness, fatigue, low blood pressure especially when standing not sweating as much in hot weather-diagnosed autonomic neuropathy have been unable to drive or work since vaccine.				Y	Y	4			N	11/01/2003	11/06/2003	5	EMG; MRI; Blood work; Autonomic testing Medical record states lab tests abnormal. msv	PVT	UNK	Loogesterol	NONE	NONE Discharge summary states sinusitis. msv Medical records states anxiety, cardiovascular disease. msv			1						1	Dizziness; Fatigue; Headache; Laboratory test abnormal; Malaise; Nausea	FLU3~EVANS VACCINES~765958~4~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0225660	08/20/2004	KY	1.75	1	.7	F	08/19/2004	Mom stated that two weeks after receiving flu vaccine on 11/7/03, the child's hair started falling out.  Follow up on 09/01/04 states: She also developed trouble with her language use 1-2 weeks post vaccine. The child could only speak the beginning syllable of a word and not finish it.  All MRI's were normal. Medical records state speech disorder. msv									Y	11/07/2003	11/21/2003	14	MRI: Normal;	PVT	PVT	Flovent, Zantac, Nosonex	NONE	Sensory Integration Issues			1						1	Alopecia; Speech disorder; Alopecia; Speech disorder	FLU3~SANOFI PASTEUR~U1128AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~u1128AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0225666	08/20/2004	TX	0.9	0	.9	M	08/20/2004	103 degree fever within 24 hours of vaccination for 24 hours. Rash/Hives all over body began 7 days after vaccination. Hives/Rash continued sporadically for 2 months. Within 30 days of vaccination developed RAD which has now been linked to allergies to Dairy and Soy. No such allergies before vaccination. Emergency Room visit for RAD required on three separate occasions.				Y					U	12/08/2003	12/09/2003	1		PVT	PVT	Prilosec	None	Reflux			1						1	Asthma; Pyrexia; Rash; Urticaria	FLU3~SANOFI PASTEUR~v1170aa~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0225690	08/23/2004	VA	42.0			M		A report was received from a non-healthcare professional on 7/12/04 concerning a 42 year old male vaccinee. Details of the vaccinees medical history were not provided. In November 2003, the vaccinee received an IM injection of Fluvirin. Approximately two weeks later, he began to experience symptoms of muscle cramping and weakness, described as MS-like symptoms. The weakness was described as moving around and has involved the legs and arms, not necessarily at the same time. The severity is described as cyclic in nature and varying over time since the onset in November 2003 from very little muscle weakness to more significant muscle weakness. All neurological examination to date, including but not limited to MRIs and physical examination have been negative to date. Infectious disease consults have ruled out Guillain Barre Syndrome. Further information is being sought. Follow up received 8/9/04 from the Neurologist: This 42 year old male vaccinee was seen by the neurologist on 1/13/04. He is a right-handed chiropractor by occupation. The vaccinees past medical history includes environmental allergies, long-standing anxiety and asthma. His medications include Flovent 220mcg twice daily and Singulair, which has now been discontinued. His anxiety has not been treated. Review of systems is negative for past history of vertigo, transient sensory or motor deficit, gait abnormality, optic neuritis, bowel or bladder dysfunction, Lhermitte's sign or diplopia. The vaccine received a flu shot in early December 2003. On 12/19/03, the vaccinee developed paresthesias involving the soles of his feet. These consist of a pins and needles sensation involving the right, greater than left foot; he then develops some numbness involving the right great toe. More recently, he has noted an ascending pattern to the paresthesias. They initially involved the posterior surface of his leg and thigh, but this has started to involve the anterior surface of his legs as well as the posterior trunk area up to about the T6 level. He denies a Lhermitte sign, associated weakness, gait abnormality and bowel, bladder or sexual dysfunction. He did report on episode of urethral burning, which as assessed by the neurologist as not related to his symptoms. Occasionally, he also notes a slight tingling sensation in the inferior orbital region as well as the bilateral median nerve distribution. The vaccinees evaluation thus far has included EMG/nerve conduction studies, which were essentially normal. There was no evidence of polyneuropathy or radiculopathy. Brain MRI scan without gadolinium showed no focal brain abnormalities. Lumbosacral MRI scan showed some minor degenerative changes only. Laboratory values included a low-normal B12 of 362, normal folate, thyroid stimulating hormone, basic metabolic panel and complete blood count with a sedimentation rate of 6 (although the neurologist states this is probably not accurate as the blood sat for more than 24 hours before the test was run). A comprehensive neurological examination was performed. Blood pressure was 136/72, pulse 64. Cognitive and cranial nerve exams were normal. Specifically, there was no evidence of an afferent pupillary defect, subtle inter-nuclear Ophthalmoplegia or disc pallor. Sensory exam was intact to all modalities. No sensory level was elicited. There was no tenderness to palpation or percussion over the spine. No muscle spasm was noted. Motor exam revealed 5.5 strength with normal tone in the upper extremities but slightly increased tone in the right lower extremity. Reflexes were 3+ in the upper extremities except 1+ at the triceps tendons and 3+ at the patellar as well as Achilles tendons. Crossed abductor reflexes and supra-patellar reflexes were present. Three beats of clonus were noted on the right side and two on the left. Abdominal reflexes were absent and Hoffman signs were mild. There appeared to be a Babinski on the right side. Cerebellar exam was intact to finger-to-nose testing, heel-to-shin testing and repetitive and rapid alternating movements. Tandem gait, Romberg test and gait were all normal. He did appear to have a very slight Lhermitte sign. Neck was supple. The reporter's overall impression was that the vaccinee has evidence of cervical myelopathy. The neurologist does not feel that this is related to his flu shot, although this certainly needs to be considered. The neurologist also doubts that his symptoms are related to a low B12, although it was thought he may improve with oral supplementation of 500mcg per day. The neurologist considers that this symptoms are related to a structural abnormality such as cervical stenosis or disc disease or a demyelinating process. Further tests have been ordered: Cervical MRI scan with and without gadolinium, brain MRI with gadolinium, median and tibial evoked potentials, sedimentation rate and C-reactive protein. The results of these tests will determine whether a lumbar puncture is necessary. Results of these tests will be sought. (OMIC) Follow up received 9/2/04: Results of further tests ordered were received. MRI of the brain, with contrast material, revealed no significant abnormalities. Median nerve and posterior tibial evoked potentials were within normal limits. Blood analysis for ESR, C-reactive protein and thyroid function on 1/27/04 were also within normal limits. Lumbar puncture on 6/8/04, showed no organisms and spinal fluid cell counts, chemistry and immunopathology were within normal limits, and negative for syphillus and Lyme disease. No further follow up is expected. There are no findings to support a specific final diagnosis for this man's symptoms, as reported.									U		12/19/2003		Basic Metabolic Panel normal; Blood pressure 136/72; Brain MRI without gadolinium: no focal brain abnormalities; CBC: probably not accurate as blood sat for more than 24 hours before the test was run; EMG/Nerve: essentially normal; Folate normal; Lumbosacral MRI: minor degenerative changes; Pulse 64/minute; Thyroid Stimulating hormone normal; Vitamin B12	UNK	UNK	Flovent; Singulair		History of environmental allergies, asthma, and long-standing anxiety.		CVOX200400262	1						1	Bone disorder; Depressed level of consciousness; Dysuria; Extensor plantar response; Faecal incontinence; Hypertonia; Hypoaesthesia; Hyporeflexia; Hypovitaminosis; Laboratory test abnormal; Muscle spasms; Muscular weakness; Myelopathy; Neck pain; Neuropathy; Paraesthesia	FLU3~EVANS VACCINES~765873~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0225691	08/23/2004	FL	69.0	68		F	08/12/2004	11/19/03: 3.30p flu shot doctors office. sxs by 5pm. Bright red face and body, rash/hives.  Treatment Benadryl and advised to go to ER if conditions gets worse. 11/24/03: trunk of body, arms, legs, face, neck covered with sores/rash, felt sick, achy and tired. Shot of dexamechazone. Prescribed Allegra pills. 11/26/04: body covered with weepy sores, blisters which broke spontaneously oozing clear fluid. Entire skin on body felt burned; inside mouth and lips sore and swollen, trouble swallowing; nausea and muscle aches. Referred to dermatologist. 1/12/04: Annual visit. Rash appears to be fading, some rash remains on face and back, lips/ inside mouth still sore and swollen. Throat tender, hard to swallow and eat, little taste. Mouth dry, lack of saliva. Fatigue.				Y					N	11/19/2003	11/20/2003	1	Blood test to check for Shogiens or other auto-immune disorders. ph acid 6.4, oxygen 17.9, Resistance to absorb and digest 134, urine ph 4.81, oxygen potential 18.3, stress (adrenals and greens taken in) 178	PVT	OTH	Estradoil, Paroxetine, Oxaprozine, Detrol LA, vitamins and food supplements	NONE	PCN Allergy			1						1	Ageusia; Aptyalism; Blister; Dry mouth; Dysphagia; Erythema; Fatigue; Laboratory test abnormal; Malaise; Myalgia; Nausea; Oral intake reduced; Pain; Pharyngolaryngeal pain; Rash; Skin burning sensation; Skin discolouration; Stomatitis; Swelling face; Urticaria	FLU3~EVANS VACCINES~765952~1~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0225752	08/24/2004	NH	50.0	49		F	08/19/2004	There was no seriousness criteria reported. However, based upon the follow up information received on 8/11/04, this case is now considered serious (OMIC). From initial information received on 2/20/04 from the patient regarding an adverse event occurring in the USA, it was reported that a 50 year old female patient received a FLUZONE vaccination, lot number U1148EA, administered in the right arm on 12/17/03. The patient stated that immediately following vaccination she had pain in her arm, and the pain worsened over six days. She was seen by an orthopedist and has been in physical therapy since 12/31/03. At the time of the report the patient has not recovered from this event. From additional information received on 7/21/04, it was reported that an x-ray of the right shoulder on 12/26/03 showed no bony pathology. The patient was diagnosed with right shoulder bursitis on an unspecified date. She was advised to see the orthopedic doctor again and was scheduled to have an ultrasound on 7/16/04. A follow up telephone call was placed to the physician on 7/22/04 and he reported that he had referred the patient to an orthopedic doctor in December 2003 and has not seen the patient that time. No additional information was provided. From additional information received on 8/11/04 from a health care professional, the patient's date of birth was reported as 2/1/1954. It was initially reported as 2/10/54. The patient was seen in the office on 12/26/03 for complaints of right shoulder pain. The patient started to experience the pain on 12/17/03 immediately after receiving her flu shot. The patient stated that it felt as though the needle hit the bone. Initially, the pain was primarily with abduction type maneuvers of that arm, but did okay beyond the arc of 90. However, it became more persistent and constant. The patient had initially been on ibuprofen for a back problem, but had recently switched to Naprosyn and noted that she had not had quite as much pain relief with that. The patient denied any numbness, tingling, or paresthesia symptoms. She rated her pain as an eight out of ten. She denied any change in pain with any cervical range of motion. The patient is left-handed and works as a veterinary technician and groomer. The patient also denied any history of erythema or soft tissue swelling noted around the shoulder. Examination on 12/26/03 revealed full cervical range of motion without pain. She was non-tender to palpation about the cervical spine. No paraspinal muscle spasm was noted. Spurling's was negative with rotation bilaterally. Scapulothoracic motion was normal. Left upper extremity range of motion was essentially full and non-tender to palpation. No laxity was noted. Right shoulder was non-tender at the AC joint. There was no pain with cross arm adduction maneuver. The patient did have some tenderness lateral to the acromion in the deltoid region, but the range of motion was active. She had full forward flexion and adduction. The patient was noted to have significant pain with abduction between the 0 and 90 degree range, beyond that she was without pain. Motor strength to the upper extremity was 5/5 to include external rotation strength. The patient was also noted to have pain with resisted abduction in a thumb down position as well as with resisted deltoid firing. She had a negative Speed test. Sensation was intact along all dermatomal patters. DTR was symmetric to the upper extremities. No atrophy was noted. An x-ray with AP, scapular Y and axillary view of the right shoulder showed no acute bony pathology. It also revealed an open AC joint-type one to two to acromion. The impression was right shoulder bursitis with no evidence on clinical examination or x-ray that injection entered the subacromial space. On 1/16/04, it was noted that per discussion with the primary physician, the patient recalled the issue of whether the needle could have entered the bursa. It was felt that it was possible, but very unlikely and, as mentioned above, there is no clinical or radiographic evidence to support or indicate an injection into the bursa. The patient was seen for a follow up visit on 2/2/04. At that time, the patient stated that her pain had improved, but she was still having difficulty with certain activities such as pushing herself out of a chair. The patient stated that she continues to work full time in her job grooming dogs. She also continues to participate in physical therapy and has made significant improvement. She begun a strengthening program and decreased her Motrin dose to 1200 milligrams daily. Physical examination showed non-focal tenderness to palpation over the arm. She had 5/5 external and internal rotation strength. She had no focal tenderness over the AC joint, but did have some tenderness in the biceps. There was no evidence of atrophy. Impingement testing was negative. The patient was noted to have full forward flexion, starting at 15 degrees of abduction, external rotation of 30 degrees, external rotation 90 degrees abduction and 90 degrees internal rotation to T6. Speed test was negative. The patient was seen again for a follow up visit on 4/16/04. Once again, she stated that her pain had improved since her last office visit two months prior. She is limited in her activities, but she had started doing more normal things such as yard work, doing raking and doing her work as a groomer. The patient stated that she felt she has made improvement, but that she did not feel 100% yet. Physical examination revealed non-focal tenderness over the AC joints and 5/5 strength testing that day. No evidence of biceps tendonitis was noted. The patient was recommended to continue with home exercise as well as to resume normal activities. It was not reported whether the patient recovered from these events.  Follow up on 11/12/04 states: From additional information received on 11/01/04 from the responsible physician, it was reported that he has not seen this pt since 12/26/03 and is unaware of her recovery status. A telephone call was made to the pt's orthopedic MD's office on 11/01/04 in an attempt to obtain additional information for this case. The orthopedist's office returned the call on 11/02/04 and reported that the pt was last seen in their office on 04/16/04. She was to follow up with her physician on an as-needed basis, but has not been back to the office since. Her recovery status is unknown. No further information is anticipated, this case is considered closed. Follow up 12/06/04: The patient recovery status is unknown, follow up information submitted to VAERS on 11/10/04.				Y					U	12/17/2003	12/17/2003	0	26Dec03-An ortho x-ray with AP, scapular Y and axillary view of the right shoulder showed no acute bony pathology. It also revealed an open AC joint type one to two to acromion. The impression was right shoulder bursitis with no evidence on clinical exam or x-ray that injection entered the subacromial space. An x-ray of the right shoulder showed no bony pathology. The pt was scheduled for an ultrasound on 16Jul04, however, no results were provided. 02/Feb/04 Impingement testing and speed test were both negative.	UNK	UNK	Hormone Replacement Therapy; Antidepressants; Lexapro; Wellbutrin	NONE	The pt's past medical history is significant for osteoporosis and osteopenia. On 02Mar1990, the pt was seen in the office with c/o right shoulder pain. Physical examination revealed right rotator cuff tendinitis, which was already resolving. Right lateral epicondylitis was also noted. Physical examination on 11May90 revealed mild residual rotator cuff tendinitis. On 12Jan93, the pt c/o right knee pain, particularly over the prior week. Per the pt she was previously evaluated about four and a half years before, when an x-ray was taken and she was told she had a kneecap problem. Examination revealed patellofemoral stress syndrome aggravated by quad strengthening exercises. On 16Mar98, the pt inverted her right ankle while walking around her car on a decline. An AP lateral and mortis view of the right ankle were obtained, which showed no bony deformity, no arthritis or fracture. The pt was diagnosed with a grade one right ankle sprain. On 02Apr01 the pt was seen for a second opinion for right wrist de Quervain's tendinitis and possible right lateral epicondylitis. The pt stated that the right wrist de Quervain's was trauma induced beginning on 04Jul00, when she was starting her rototiller with a pull cord and the pull cord sucked her hand back into the machine, hitting her wrist on the rototiller. Two days later, the pt noticed some bruising and increased pain and began having a snapping sensation with range of motion of the thumb over the area of the tendon. On 01Sep00, the pt was seen by a physician, who felt that the pt had a de Quervain's tenosynovitis and placed her in a splint for two weeks. The pt noticed no improvement with this course of treatment and returned to the office in late September and received a cortisone injection. Three weeks later, she started noticing some atrophy on the medial volar aspect of her right wrist. Starting in December, she noticed some tightness with opening her hand with no attributable injuries including change in activity or injury. Beginning in early February, the pt started noticing some pruritus in the lower aspect of that same right wrist without any notable rash. She also notice at that point that the atrophy seemed to progress further up her forearm. She was seen again in late February by the physician and diagnosed with right tennis elbow and has been doing exercises since. She did have some subcutaneous atrophy at the volar aspect of her wrist on the radial side. Right hand x-rays showed no acute bony pathology. The impression was mild lateral epicondylitis and right wrist de Quervain's tenosynovitis with subcutaneous atrophy, probably as a result of the cortisone injection. The pt was newly diagnosed with osteoporosis at that time and was started hormone replacement therapy. The pt also has a history of anxiety and depression. She has no history of diabetes or thyroid disorder. The pt denied any history of erythema or soft tissue swelling around the shoulder.		200400663	1						1	Bursitis; Myasthenic syndrome; Pain; Shoulder pain; Tenderness	FLU3~SANOFI PASTEUR~U1148EA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0225908	08/27/2004	TN	43.0	43		F	05/18/2004	Pt states received flu and pneumonia shot 11/25/03. Pt states it hurt during administration. Pt states arm hasn't been right since. Pt said called HD and spoke with unidentified nurse.				Y					U	11/25/2003	11/25/2003	0	MRI, X-ray	PUB	UNK	Diabetes Meds	NONE	All cillins and mycins, diabetes and asthma		TN04042	1						1	Feeling abnormal; Pain	FLU3~EVANS VACCINES~765980~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0710M~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0225968	08/29/2004	MO	24.0	24		M	08/29/2004	The adverse events started the week before 11/19/02.  I was having numbness in my left arm.  I also was having problems in steadying a shotgun and hitting the target in practice.  I felt very unsteady on a ladder. All of this is hindsight information.  In the early morning of 11/19/02 I was in an operating room as a medical student and started getting an exteremely bad headache.  On rounds at 6am I found myself running into doors/wall and the headache worsening.  I went home thinking I had a bad migraine from staying up all night. When I awoke at 10:30 am I was paralyzed on the left side of my body completely.  I crawled to the phone and called 911.  By the time I was at the hospital I was in status epilepticus.  I was given Dilantin, Phenobarbital, and Depakote to control the seizures. When they found what they though was a brain tumor they gave me Propofol and placed me in an induced coma. On 11/21 I underwent a brain biopsy which ruled out a tumor. My intracranial pressure increased to dangerous levels by 11/23/04 and a ventriculostomy tube was inserted to control the pressure. When all the infectious diseases came back negative I was placed on IVIG and steroids.  My outlook improved and by 12/11 I was removed from the induced coma.  I was transferred to another hospital on 12/16/02 for rehabilitation.  On 1/3/03 I was released from inpatient rehab and sent to outpatient rehab until 3/15/03.  Then On 11/23/03 I had a grand mal seizure after being back on rotations for 2 months.  I have struggled with simple partial seizures since then and just now are starting to get them under control.  Nurse follow up on 10/30/04 states: No new information. Per annual report- Partial seizure disorder treated with 200 mgLemictal BID & 2g Keppra BID.  Pt has sensation problem in left leg, coordination problem in gross motor function such as playing sports.  Has also developed cluster headaches.  Pt is a medical student and having problems with concentration esp under time constraints. Medical records state encephalitis, apnea, rash and allergic reaction. msv			Y	Y	Y	41			N	10/31/2002	11/19/2002	19	Brain biopsy neg for neoplasm but consistent with mixed histiocytic and neutrophilic infiltrate found in hyperacute variant of Accute Disseminated Encephalomyeinitis  CT scan showed large hypodensity in right temporal parietal region with mass effect and midline shift.  MRI showed right temporal parietal posterior frontal and corpus callosum effected  CSF culture shows the following: (+)Propionibacterium Acnes (-)herpes types 1 and 2 (-)oligoclonal bands (-)mycoplasma pneumonia (-)myelin basic protein (-)Toxoplasmosis (-)Blastomycocosis (-)coccidiomycosis (-)histoplasmosis (-)cold agglutin (-)california encephalitis (-)St. Louis encephalitis (-)Eastern Equine encephalitis (-)Western Equine encephalitis (-)Arbovirus (-)west nile virus (-)cryptococcus (-)gram stain	UNK	UNK	None	None	None			1						1	Apnoea; Balance disorder; Confusional state; Disturbance in attention; Encephalitis; Grand mal convulsion; Headache; Hemiplegia; Hypersensitivity; Hypoaesthesia; Intracranial pressure increased; Laboratory test abnormal; Rash; Sensory disturbance	FLU3~EVANS VACCINES~E37202LA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0214415	08/30/2004	GA	32.0			F		There are no seriousness criteria reported in the case described below. Based upon appropriate medical judgement this case is considered non serious. From initial information received on 28DEC2003 through an enhanced surveillance program conducted by the CDC and Prevention, regarding an adverse event occurring in an unknown country, it was reported that a 32 year old female pt received Yellow Fever Vaccine, DT toxoids , Meningococcal Vaccine, Influenza Vaccine, Poliomyelitis Vaccine Activated, Hepatitis A Vaccine and Hepatitis B vaccine on 15dEC2003 in preparation for a trip around the world. Seven days later, on 22DEC2003, the pt was seen in the ER for a severe headache, stiff neck and a low grade fever of less than 100 degrees F. No lumbar puncture was done and the pt was released. No other information was provided.  From additional information received on 05FEB2004 through an enhanced surveillance program conducted by the CDC and Prevention, it was reported that this pt was form Atlanta. it is unknown whether the pt was tested for influenza. Because this event occurred in the USA, the product coding for Yellow Fever Vaccine, DT toxoids, Meningococcal Vaccine have been updated to YF VaX, TD ADS Adult and Menomune A/C/Y/W-135. No new medical information has been provided. Corrective version: The product information has been updated as follow. TD ADS ADULT updated to DT toxoids, manufacturer unknown. Inactivated Polio Vaccine, manufacturer unknown, updated to IPOL.				Y					U	12/15/2003	12/22/2003	7	All blood work and urinalysis were normal, including liver function tests, kidney function, CDC and platelets. No lumbar puncture was done. No labs were sent. It in unk whether the pt was tested for influenza.	UNK	UNK					200303619	1						2	Headache; Musculoskeletal stiffness; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~2|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~2|IPV~SANOFI PASTEUR~~UNK~~~POLIO VIRUS, INACT. (IPOL)~2|MEN~SANOFI PASTEUR~W135~UNK~~~MENINGOCOCCAL (MENOMUNE)~2|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~2|YF~SANOFI PASTEUR~~UNK~~~YELLOW FEVER (YF-VAX)~2	USA	Emergency room visit	Influenza
0226102	09/01/2004	IL	76.0	75		M	08/30/2004	There was no serious criteria reported. However, based upon the follow up information received on 8/25/04, this case is now considered serious (OMIC). From initial information received on 6/14/04 from the patient regarding an adverse event occurring in the USA, it was reported that a 75 year old male patient received a dose of FLUZONE, lot number U1255AA, administered in the right arm on 11/10/03. The route of administration was not reported. Seven hours later, the patient developed hematuria. He also experienced nausea and vomiting, but the onset was not reported. The patient was evaluated by a urologist, as well as the responsible physician and symptoms were treated with Cipro and ampicillin. His hemoglobin decreased from 14 to 9 and his creatinine increased from 2.2 to 4.9 and the patient is to see a nephrologist on 7/26/04 due to his lab work. His past medical history is significant for arthritis and a gastrointestinal disorder, possibly gastroesophageal reflux disease or ulcer disease. His concomitant medications at the time of vaccination included Sea Silver, an over the counter supplement. He has not recovered from these events. From additional information received on 8/25/04 from a voice mail message from the patient, it was reported I am the patient affected by flu vaccine 125AA. I'm on dialysis because my creatinine increased and it's from the vaccine. His recovery status was not reported. Based on medical judgement, this case has been upgraded to serious. Additional information has been requested. A return call was received from a doctor, the physician for this patient. The doctor stated he saw patient on 8/26/04. He reported that he had a history of bladder cancer from 12/02 for which he did not seek treatment. He was diagnosed in a different state and still has not provided his medical records. He had episodes of hematuria prior to his vaccination. He did receive a Flu vaccine on 11/10/03. In his medical judgement, the patient's hematuria and kidney problems had nothing to do with the vaccine.				Y					N	11/10/2003	11/10/2003	0	The patient's hemoglobin decreased from 14 to 9 and his creatinine increased from 4.0 to 2.2. 8/26/04: The information above should be: creatinine increased from 2.2 to 4.0.	UNK	UNK	Sea Silver		The patient has a history of arthritis and a gastrointestinal disorder, possibly gastroesophageal reflux disease or ulcer disease. He had no specific illnesses at the time of vaccination and had previously received influenza vaccines. No adverse events were reported following prior vaccination. From physician telephone call 8/27/04: Patient had a history of hematuria and bladder cancer since 12/2002 for which he did not seek treatment. His physician still has not received his previous medical records.		200402111	1						1	Anaemia; Blood creatine phosphokinase increased; Condition aggravated; Haematuria; Haemoglobin decreased; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U1255AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0226391	09/08/2004	GA	1.2	1	.2	M	09/08/2004	High fever (102.5) within 12 hours of vaccination.  Fever of 100.5-101.5 for the next 36 hours.  Irritable.  Treated with children's motrin.									Y	09/07/2004	09/07/2004	0		PVT	PVT		getting over a cold	Reactive Airway Disease.  Seasonal Allergies.			1						1	Irritability; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~ID~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0226501	09/10/2004	DE	24.0	23		F	09/06/2004	About 7 days following her flu vaccine, noted muscle aches and developed vomiting, diarrhea and sweats. Went on sick call and instructed to increase po fluids. Sxs lasted approximately x 2 days. In late October 2003, started noting altered sensation in both feet and ankles. Had not experienced this sensation prior to October 2003. First instance was noted when she stood up and stumbled because she could not feel her feet. Since October, has experienced episodes of decreased sensation and numbness in both feet, but loss of sensation seems greater on left than right foot. Episodes occur approximately 2-3x/week. Has not noted an increase in frequency since November. Describes sensation as numbness with each episode resolving spontaneously after about 15-20 minutes. No change in character of sensation since onset. No associated sxs such as dizziness or clumsiness. Not triggered or associated with positioning. No back or lower extremity pain or weakness. Unable to identify precipitating or aggravating factors. Not sure if onset prior to or following influenza vaccine on October 22nd. Sought evaluation for this problem in early November, about 1 week after onset. Evaluated by neurologist on 11/11/003. EMG was completed and reported to be normal. A1C Harris' was told her vitamin B12 level was slightly low and she was started on Prenatal vitamins. Her blood glucose level was normal. Neurology evaluation is ongoing. Sxs: Numbness Start: 10/28/2003 Comment: altered sensation in both feet and ankles (decreased sensation and numbness).				Y					N	10/22/2003	10/28/2003	6	Diagnostic Tests: 10/21/2003 MRI head with and without contrast: Two punctuate nonspecific white matter hyperintensities otherwise unremarkable brain MRI: 12/09/2003. EMG of lower extremities to rule out peripheral neuropathy. IMPRESSION: This is a minimally abnormal study. The only notable finding was a diminished amplitude repsonse from the left peroneal motor nerve recording from EDB. This finding may represent a neuropathy of the distal motor branch to that muscle. The significance of this finding should be interpreeted with caution as it can be seen in asymptomatic individuals. There is no evidence to suggest a diffuse and widespread peripheral neuropathy. 4/20/04. MRI Impression: too numerous to count punctuate T2 and flair hyperintensity within the white matter bilaterally c/w but not diagnostic of MS. No evidence of abnormal contrast enhancement to suggest active demyelination.	MIL	MIL		Headaches	At time pt associated all sxs with anthrax vaccines given in April and July 2003.			1						1	Clumsiness; Depressed level of consciousness; Diarrhoea; Dizziness; Hyperhidrosis; Hypoaesthesia; Laboratory test abnormal; Myalgia; Sensory disturbance; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0226519	09/13/2004					F		A report was received from a female consumer (age not reported) in the USA on 08/30/2004.  Details regarding her medical history or concomitant medications were not provided. On 12/01/03, the vaccinee received an IM injection of an influenza vaccine (manufacturer unknown). Within one week, the vaccinee began to experience rib pain, back pain and swollen and painful feet. In 01/04, the vaccinee was seen by a primary care physician who indicated that she had serum sickness. There was a rash at the top of her foot and it was painful to walk. At the time of this report, the swelling and pain in her feet persists and she also has swollen hands. The back and rib pain have now resolved. Further information will be sought.									U	12/01/2003	01/01/2004	31		UNK	UNK	Concomitant drugs not reported.				CVOX200400285	1						1	Back pain; Difficulty in walking; Oedema peripheral; Pain in extremity; Rash; Serum sickness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0226521	09/13/2004		72.0			M		A report was received from a healthcare professional in the USA on 8/3/04 concerning a 72 year old male vaccinee. On 10/4/02, the vaccinee received Fluvirin (batch E34682HA) via an unknown route of administration. On 10/13/02 the vaccinee was admitted to hospital with blurred vision, truncal ataxia and impaired ambulation. Due to legal ramifications the reporter was not able to provide any additional information regarding this event. The reporter is a legal nurse consultant and she is working on a case where a suit has been brought against a physician. She is working in the defense of the physician.					Y				U	10/04/2002				UNK	UNK	Concomitant drugs not reported.				CVOX200400288	1						1	Coordination abnormal; Difficulty in walking; Vision blurred	FLU3~EVANS VACCINES~E34682HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0226622	09/15/2004	CA	49.0	49		F	08/06/2004	Sore chest and butt muscles. Then sore feet and ribs; hurt to turn in bed. Then swollen foot with rash at 2 weeks; could not walk. Something in my tailbone or nerves? Now it is in the hands, feet, and left knee. Per annual report- Still have swelling on my left hip (per MRI), 3 fingers and right foot.  I'm using crutches.  Soreness moves around in my right shoulder and neck, knees.  This past week I can feel it will be leaving.  I was told by my doctor this will be a slow recovery in August 2005. The pain is not as severe anymore. Medical record sttes arthralgia. msv								Y	N	12/01/2003	12/01/2003	0	CBC; ESR; CMP; Thyroid; Antibody titer; Rheumatoid Factor. Medical record states lab test abnormal, hematuria. msv	PVT	OTH		Fever; Getting over a cold/flu.	Sulfa allergy			1						1	Abdominal pain; Arthralgia; Chest pain; Difficulty in walking; Haematuria; Laboratory test abnormal; Myalgia; Oedema peripheral; Pain in extremity; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0226873	09/21/2004	CA	65.0	64		F	09/21/2004	4x8 cm indurated, hot area, right deltoid, around injection site				Y					Y	09/20/2004	09/20/2004	0	none	UNK	UNK	Synthroid 112 mcg qd Activella qd Dyazide 37.5/25 qd	none	hypothyroidism elevated liver enzymes			1						1	Injection site induration; Injection site warmth	FLU3~SANOFI PASTEUR~U1512AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0944N~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0226988	09/24/2004	MA	0.75	0	.8	F	09/16/2004	Around 24 hours after vaccine, pt went limp, eyes rolled back. Positive breathing. Event lasted a few seconds. Afterwards , patient was clingy and out of it for a few hours.				Y					Y	09/15/2004	09/16/2004	1	NONE	PVT	PVT		NONE	NONE			1						1	Abnormal behaviour; Eye movement disorder; Hypotonia	FLU3~SANOFI PASTEUR~U1425AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0467N~3~IM~RL~HEP B (RECOMBIVAX HB)~1|PNC~PFIZER\WYETH~494333~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0227002	09/24/2004	PA	1.02	1	.0	F	09/24/2004	Pt. received vaccine at 11:30 AM 9/23. Developed fever few hours later. Had staring episodes at 10:30 PM, became unresponsive 11 P, EMS activated taken to hospital. Intubated, transferred to another hospital. Anti-epileptic medications administered. Medical Record received on 1/3/2005 states abnormal gait, sleepy, limp, and vomit.			Y	Y	Y	5			U	09/23/2004	09/23/2004	0	Medical Record received on 1/3/2005 states X-Ray abnormal.	UNK	UNK	none	none	Discharge Summary received on 1/3/2005 states congenital abnormal carotid artery. Medical Record received on 1/3/2005 states irritable and diarrhea.	leg swelling, high pitched cry~DTP (no brand name)~1~0.20~Sibling|~DTP (no brand name)~~0.00~Sibling		1						1	Coma; Convulsion; Gait disturbance; Hypotonia; Hypoxia; Laboratory test abnormal; Pyrexia; Somnolence; Staring; Vomiting	FLU3~SANOFI PASTEUR~V1442AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~494754~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Life Threatening,Hospitalisation	Influenza
0227010	09/24/2004	NC	37.0	37		M	09/24/2004	Right sided pain and paresthesias to face, upper extremity, lower extremity starting 5-7 days after receiving multiple shots; painful right sided lymphadenopathy at temple, ear, anterior neck; symptoms have improved slowly but not resolved - tried NSAID's and Neurontin with limited success.									N	03/01/2004	03/06/2004	5	CBC, u/a, ESR, CRP - WNL head/neck MRI - WNL EMG/NCV - wnl CMP, TSH, RPR - pending	MIL	MIL	none	none	GERD-controlled carpal tunnel syndrome-stable			1						1	Lymphadenopathy; Pain; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~UNK~IM~UN~MENINGOCOCCAL (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~IM~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|TYP~UNKNOWN MANUFACTURER~~UNK~IM~UN~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0227014	09/25/2004	SC	56.0	56		M	09/25/2004	Shot was given on Monday 9/20/2004 at approximately 3:50pm. By the next afternoon around 2:30pm patient began to feel lethargic, fever increased, pain in all joints, sweats, chills, lightheadedness with fever peaking out at 102 on Thursday 9/23/04.  By Friday evening 9/24/04, the fever went down to 99 which was the lowest since Tuesday.  During the early morning hours of 9/25/04 at 4:30am, I awaked in a wet bed with my hair all wet and perspiration just running off my body, the fever was at 102 again and still is at 11:25am.  I have been taking Tylenol 500mg X 2 since Tuesday and using cold compresses as instructed by the clinic.  I am still feeling miserable and have received flu vaccines for 15 years without any reactions like this.  If it goes any higher than 102, I will go to the emergency room. Patient additionally developed UTI; improving with antibiotics.									N	09/20/2004	09/21/2004	1		MIL	UNK	Venlafaxine, Trazadone and Temazepan	None	Allergic to sulfa drugs, codeine and anti inflammatories			1						1	Arthralgia; Chills; Dizziness; Hyperhidrosis; Lethargy; Pyrexia	FLU3~SANOFI PASTEUR~U1411AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227018	09/27/2004	KS	31.0	30		F	10/18/2004	From initial information received on 9/21/04 from the patient regarding an adverse event occurring in the USA, it was reported that a 30 year old female patient received an INFLUENZA VACCINE, lot number and manufacturer were not reported, administered in the arm on approximately 12/18/03. On approximately 12/24/03, the patient developed severe congestion, shortness of breath, difficulty breathing, constipation and chronic fatigue that lasted for months and still continues, but is less severe. The patient had emergency room visits, but was never admitted (dates unknown). She has had IV oxidation treatments. The difficulty breathing, constipation and chronic fatigue continued to persist. The patient reports severe allergies to foods, including eggs, wheat and corn. She has a follow up visit scheduled with a pulmonologist and plans to follow up with another alternative medicine doctor. The patient reported that she is not sure if she received Fluzone or Fluvirin in December 2003. The patient has not recovered from these events. (OMIC) From additional information received on 13OCT2004 from a health care professional, it was reported that the patient experienced symptoms of a chest cold on 26DEC2003. She was seen multiple times in the ER and urgent care facilities and underwent a thorough evaluation including an electrocardiogram and a chest x ray , which showed bibasilar atelectasis and infiltrates. Blood work included D. dimer and arterial blood gasses, however, no results were provided. A CT scan of the chest on 15MAR2004 was normal. She has a pulmonary consult and it was felt that she had a respiratory infection, as well as a history of asthma. I was not reported whether the patient recovered from these events.  From additional information received on 8NOV2004 from a health care facility, the patient's consent for influenza vaccine administration was provided. According to the consent, the pt does not have allergies to eggs, chicken , chicken feathers, chicken dander, mercury or thimerosal. In addition, the patient does not have sever latex sensitivity or an acute illness with fever. She did not have a fever within the 24 hours prior to vaccination. Reportedly, she received a dose of Influenza Vaccine, expiration date 30JUN2004 , in the right deltoid. Patient's pulmonologist's contact information was provided. The patient was last seen by the pulmonologist on 1MAR2004. At that time, she was felt to have bronchial asthma, cough and allergic rhino sinusitis. She underwent a chest x ray and a CT scan. Per pulmonologist, the chest xray demonstrated congestion, but was better than the lat one and the CT scan was okay. Cspine x ray obtained on an unspecified date demonstrated soft tissue swelling. PA chest xray, obtained on 4MAR2004, demonstrated atelectasis. Patient's concomitant medicatioons at the time of vaccination included Albuterol, Aerobid, Biaxin, Zithromax and other unspecified antibiotics. The patient did not receive an influenza vaccine last year. No further information is anticipated. The case is considered closed.				Y					N	12/18/2003	12/24/2003	6	CAT scan (inflammation). Chest x-rays were clear. It is not clear whether the patient had an EDS test. From additional information received on Oct 13, 2004 it was reported that the pt underwent a thorough evaluation including an EEG and a chest x-ray, which showed bibasilar atelectasis and infiltrates. Blood work included D dimer and arterial blood gasses, however, no results were provided. A CT scan of the chest on 15Mar04 was normal. From additioal information received on 8NOV2004, it was reported that the patient underwent a chest xray and a CT scan. Per patient's pulmonologist, the chest xray demonstrated congestion, but was better than the last one and the CT scan was okay. C spine x ray obtained on an unspecified date demonstrated soft tissue swelling. PA chest xray , obtained on 4MAR2004, demonstrated atelectasis.	PUB	UNK	Albuterol, Aerobid, Biaxin, Zithromax, Antibiotics		The patient reports severe allergies to food, including eggs, wheat, and corn. She initially reported chest tightness symptoms on 20Nov03. It was also felt that the pt has a hx of asthma. According to the consent, the pt does not have allergies to eggs, chicken , chicken feathers, chicken dander, mercury or thimerosal. In addition, the patient does not have sever latex sensitivity or an acute illness with fever. She did not have a fever within the 24 hours prior to vaccination. The patient did not receive an influenza vaccine the prior year.		200403101	1						1	Asthma; Atelectasis; Constipation; Cough; Dyspnoea; Fatigue; Rhinitis allergic; Upper respiratory tract infection; Atelectasis; Condition aggravated; Constipation; Cough; Dyspnoea; Fatigue; Lung disorder; Nasal congestion; Oedema; Respiratory tract infection; Sinusitis	FLU3~EVANS VACCINES~765796~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~EVANS VACCINES~765796~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0227022	09/27/2004	PA	50.0	49		F		On Thursday, 10/30/03, I had received a flu vaccine while on the job. The injection was given IM by the nurse. Immediately after I had received the injection, I began to feel very ill. A cold chill went through my body and I had to sit down in the pharmacy. The next day, 10/31/03, I was not able to get off the sofa at my home. I was not required to go to work until 11/5/03. I had then began to feel somewhat better, however, I still had a persistent headache. Then, on 11/6/03, I had such a severe headache I could not hold my head up. My friend drove me to the emergency room. The diagnosis at the ER was that I had the flu and a urinary tract infection and I was sent home with Levaquin 400mg for 4 days. My friend had informed the hospital that I have had a history of genital herpes, and that I did not have an outbreak at that time. I was then sent home from the hospital in the care of my mother and brother. The severe headache gradually got better, however, I developed double vision for part of the next day, 11/7 and was severely vomiting. I gradually began to feel better from 11/8 to 11/14, and returned to work on 11/16. I continued to have a dull headache and some neck pain and tingling in my fingers. On 12/10 I went to see the doctor. I explained my symptoms to the doctor and he suggested that I see a neurologist. The doctor told me that he though I had viral encephalitis. While I was at work on 12/14/03, I was transposing numbers on the computer. Suddenly, the telephone rang in the pharmacy but I picked up the stapler and was talking to it. I was immediately taken to the hospital. After a spinal tap was done, I was diagnosed as having herpes simplex encephalitis. While in the hospital for 4 days, I was given Acyclovir 550mg IV every 8 hours and was then sent home on this same medication through 12/24. I have enclosed documentation from the hospital. I am currently seeing a doctor. I am also seeing a neurologist at the hospital. Currently, I am going to speech therapy 3 times weekly. Soon I will begin to do work simulation at the rehab center. I hope to return to my job as a pharmacist soon.  Per the annual follow up report I am still taking Depatkote ER, I am taking Zovirax daily also. I truly believe that anyone who has active cold sore virus or herpes simplex should not receive a flu vaccine. Also whether the herpes is active or not active do not receive a flu vaccine. Once you have had herpes virus it is always in your system. I believe the flu vaccine activates a dormant herpes virus and causes a terrible reaction. When I received the flu vaccine I became very ill afterward. I then had a seizure and was hospitalized for 3 days. I had one year of speech therapy for memory loss. I am presently working 30 hours a week as a pharmacist.			Y	Y	Y	4		Y	N	10/30/2003	10/30/2003	0		OTH	UNK		NONE				1						1	Abnormal behaviour; Amnesia; Chills; Convulsion; Diplopia; Encephalitis; Headache; Herpes simplex; Influenza; Malaise; Neck pain; Paraesthesia; Urinary tract infection; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0227024	09/27/2004	NJ	4.0	4		M	09/21/2004	Lethargy, Diffuse erythema, Coughing				Y					Y	09/15/2004	09/15/2004	0		PVT	PVT			Egg, Wheezing			1						1	Cough; Erythema; Lethargy	FLU3~SANOFI PASTEUR~U1383AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0416P~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0227025	09/27/2004	MD	14.0	14		F	09/21/2004	Seizure activity x 2 @ 6AM upon waking. Slept x 4 hours : fine now. Seizure medication level pending.  Nurse follow up on 10/30/04 states: There are no new information.									Y	09/20/2004	09/21/2004	1		PVT	PUB		Yeast Infection. Treated with Diflucan	Post concussive seizure disorder (x1 year), Asthma, Vaginitis			1						1	Convulsion	FLU3~SANOFI PASTEUR~UK119AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U1397AA~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0227061	09/28/2004		59.0			F		A report was received from another pharmaceutical company on 1/15/04 concerning a 59 year old female vaccinee who experienced redness and pain at the injection site and 2 by 2.5 necrotic area at the injection site on 11/18/02, which was considered medically significant and required surgical intervention (OMIC), after receiving influenza vaccine and Pneumovax 23 on 11/13/02 at 13:30 hours. The vaccinee has a medical history of allergy (comatose) to codeine. On 11/13/02 the vaccinee was administered influenza vaccine and pneumococcal 23v polysaccharide vaccine in the same site. The vaccinee experienced redness and pain at the injection stie an unspecified length of time following vaccination. Unspecified medical attention was sought. On 11/18/02 the vaccinee had developed a 2 by 2.5 necrotic area at the injection site, which was surgically removed 2 weeks later. The outcome of the events was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.				Y					U	11/13/2002	11/18/2002	5		UNK	UNK	Concomitant drugs not reported.		Allergy to codeine.		PJP200400093	1						1	Injection site erythema; Injection site necrosis; Injection site pain; Injection site erythema; Injection site necrosis; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0445M~UNK~IM~~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0449M~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0227064	09/28/2004	OH	3.0	3		M	10/18/2004	From initial information received on 9/22/04 from a healthcare professional regarding an adverse event occurring, it was reported that a three year old male patient received a first dose of FLUZONE, lot number U1489AA, administered in the left thigh on 9/15/04. Six days later, on 9/21/04, the patient was seen in the physician's office with coughing, sneezing, congestion, shortness of breath, and fever (per the patient's mother). He was sent to the emergency room and was admitted to the hospital the same day. A chest x-ray showed pneumonia. The results of cultures were not available at the time of this report. The patient is currently still hospitalized and has not recovered from these events. From additional information received on 13Oct04 from a health care professional, it was reported that the pt had a cough, low grade fever and intermittent wheezing three to four days prior to being seen in the ER, where he was diagnosed with pneumonia and perscribed Azithromycin. For the next 24 hours the pt continued with a cough, but had become afebrile. He was seen by a physician on 21Sep04 and it was noted that he had some papular lesions developing on his upper extremities, left forehead and his left ear lobe seemed to be erythematous and swollen. The pt had decreased oral intake and his mother stated he probably had been urinating somewhat less than normal. He was admitted to the hospital that same day. His physical examination was normal, except for some scant mucoid rhinorrhea and a few bilateral anterior cervical lymph nodes. His chest was clear to ausculatation. He had one small papular region on the dorsal aspect of the left wrist and one on the ventral aspect near the elbow, as well as a small papula on the left upper forehead. The pt was diagnosed with probable pneumonia. The Azithromycin was continued, as well as encouraged increased oral fluids. A consulting physician expressed doubts that the papular lesions were another outbreak of shingles or HSV, since the lesions were not vesicular at that time. He did not recommend acyclovir at that time, but would reconsider antiviral therapy, along with submission of a specimen for viral isolation if the lesions became vesicular. It was not reported if the pt recovered.				Y	Y				N	09/15/2004	09/21/2004	6	A CBC and BUN were within normal limits. A chest x-ray showed pneumonia. No culture results were available at the time of this report.	PVT	UNK	Singulair; Zyrtec		The patient has a history of asthma. He did not have any illnesses at the time of vaccination. From additional information received on 13Oct04 from a health care professional, it was reported approx five weeks prior to admission, the pt developed pneumonia and was treated as an outpatient. He also developed a fairly classic outbreak of zoster on the lateral aspect of the right calf that extended onto the dorsum of the foot. He was treated with oral acyclovir, pain control and antipyretic medicine and had healed. The pt does not have a history of varicella, but it was reported that he must have had varicella prior to the outbreak of zoster five weeks prior to admission. Hospital records state that the pt did not have a history of reactive airway like disease. His immunizations were said to be up to date.		200403108	1						1	Cough; Dyspnoea; Herpes zoster; Medication error; Nasal congestion; Pneumonia; Pyrexia; Rash papular; Rhinorrhoea; Sneezing	FLU3~SANOFI PASTEUR~U1489AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0227138	09/29/2004	CA	19.0	18		F	09/29/2004	Feeling sickly, flushed, nausea and vomiting, full body shaking tightness in chest 2 epi pens (0.6 mg) and 50mg Diphenhydramine PCR protocol-then Ambulance arrived on scene. Medical record states dyspnea.msv Medical record states allergic reaction. msv				Y					Y	09/24/2004	09/24/2004	0		OTH	OTH	NONE	NONE	NONE Medical record states Hx of hypoglycemia. msv			1						1	Chest discomfort; Dyspnoea; Flushing; Hypersensitivity; Myalgia; Nausea; Tremor; Vomiting	FLU3~SANOFI PASTEUR~U1440AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227139	09/29/2004	NJ	12.0	11		F	09/10/2004	A pt's mother reports her 11 year old daughter developed asthmatic reactions and nasal polyps after receiving intranasal Flumist. On 17Dec03, an 11 year old female received FluMist for immunization against influenza virus. On 31Dec03, the pt went to ER after developing asthmatic reactions where she was treated with salmeterol xinafoate/fluticasone propionate and pirbuterol acetate. The pt also received fluticasone propionate and montelukast sodium for nasal polyps. The pt is still receiving medications and has not yet recovered from the events. The reporter did not provide relationship between events and FluMist vaccination.				Y					U	12/17/2003	12/31/2003	14	Test for allergy to FluMist negative	PVT	UNK	NONE		NONE		MEDI0002229	1						1	Asthma; Nasal polyps	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0227143	09/29/2004	NJ	0.5	0	.5	M	09/22/2004	Shaking of arms, starting x 15 sec. No fever at the time. Pt has had similar events in the past not temporally related to vaccines.									Y	09/17/2004	09/18/2004	1	NONE	PVT	PVT	NONE	NONE	2 episodes of possible seizures in the past			1						1	Similar reaction on previous exposure to drug; Tremor	DTAP~SANOFI PASTEUR~C1624AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1419AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~5529B9~2~IM~RL~HEP B (ENGERIX-B)~1|HIBV~SANOFI PASTEUR~UE415AA~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A74404H~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0227144	09/29/2004	NY	0.51	0	.5	M	09/22/2004	Parent transferred care. Pt received 0.5ml of Fluzone instead of 0.25ml. No adverse events were known to occur.									Y	09/21/2004			NONE	PVT	PVT	NONE	NONE	NONE			1						1	Medication error	DTAP~SANOFI PASTEUR~C1698AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1421AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A57559K~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0227190	09/29/2004	LA	55.0	54		F	09/29/2004	Redness, erythema at injection site, warm to touch, somewhat painful, was treated with Z-pack Tripack 1 po qd x3 days. Site of problem left arm (Pneumovax)									Y	09/27/2004	09/28/2004	1		UNK	UNK	Bextra 20mg 1 po qd Prevacid 30mg 1 po qd Evista 60mg 1 po qd CalcimD 500mg 1 po bid Indapamide 15mg 1 po qd Accupril 20mg 1 po qd Vistaril 25mg 1 po qhs Wellburtin 150mg 1 po bid Avandia 4mg 1 po qd	Diabetes, Hypertension, Plantar Fascitis	none			1						1	Injection site erythema; Injection site pain; Injection site reaction; Injection site warmth	FLU3~SANOFI PASTEUR~U1410BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1138N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0227195	09/29/2004	CO	0.81	0	.8	F	09/29/2004	Fixed eyes one day after vaccination for about 30 seconds, with redness of her face and no related with  fever. The same event happened  again 5 days later. No  neurologic deficit was seen afterwards. She was seen by a pediatric neurologist who ordered an EEG and a RMN that where both normal. She did not have any  treatment for these events.				Y					Y	09/10/2004	09/11/2004	1	EEG normal RMN normal	UNK	UNK		None	displasic hip development			1						1	Flushing	BCG~UNKNOWN MANUFACTURER~E420277~1~ID~LA~BCG (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~AFLUA028BC~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~5328A4~3~IM~RA~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0227196	09/29/2004	CO	9.0	8		M	09/29/2004	Injection site redness, pain, warmth that continued to increase in size for 3 days.  About 12 cm in diameter.  Improved within 24 hours of starting Keflex p.o.				Y					Y	09/20/2004	09/21/2004	1		UNK	UNK		Hemorrhoids, constipation	Atrial septal defect			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U1418AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227225	09/30/2004	OH	1.13	1	.1	M	09/30/2004	Patient developed hives 24 hrs after vaccine was administered.  He was examined on 9-30-04, 2 days after the vaccine, and still had hives which were treated with Benadryl.				Y					U	09/28/2004	09/29/2004	1	None	UNK	UNK						1						1	Urticaria	FLU3~SANOFI PASTEUR~u1421aa~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227279	10/01/2004	VA	3.0	3		M	10/01/2004	Redness, warmth and mild pruritis from the vaccine site on skin overlying triceps to the elbow almost circumferentially, left arm affected. Reaction on left arm, at site of Hep A vaccination.				Y					Y	09/28/2004	09/28/2004	0	CBC normal	UNK	UNK	None	None	s/p tymapnostomy tubes Mild Allergy to Pineapple ( Hives)			1						1	Injection site erythema; Injection site reaction; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U1383AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1234N~2~IM~LA~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0227283	10/01/2004	GA	55.0	54		F	10/01/2004	Had flu shot and pneumonia shot 9/30/2004. On 10/1/04, headache, fever, muscle aches.									Y	09/30/2004	10/01/2004	1		UNK	UNK	Lisinopril Toprol-XL	None.	CHF-cardiomyopathy			1						1	Headache; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1383AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1201N~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0227287	10/02/2004	CA	63.0	62		M	10/02/2004	Pain in shoulder within one hour. Pain increased in intensity over the next 24 hours.  No sleep the night of the injection for no apparent reason.  Fever, extreme weakness, moderate to severe headache, uncontrolled, violent shivering, and severe shoulder pain by 1500 the afternoon after the injection. Per annual report- although both pneumo and influenza were included the original report, the adverse event was directly attributal to the pneumo injection.Medical record states cellulitis, sweat, myalgia. msv				Y	Y	4			Y	09/25/2004	09/26/2004	1	CBC - ever increasing white blood cell count. Blood cultures - unknown results. CT scan of the head - normal. MRI of the shoulder - fluid build up in right deltoid. Spinal tap - normal. Possibly others. Medical records states abnormal lab tests, hypokalemia, increased sgot, sgpt. msv	UNK	UNK	Crestor 10 mg Nexium 40 mg Benicar HCT 20-12.5mg Niacin 2 grams daily - per MD. One aspirin.	NONE	High Chlorestrol High blood pressure Indigestion Medical record states allergic reaction. msv			1						1	Alanine aminotransferase increased; Aspartate aminotransferase increased; Asthenia; Cellulitis; Chills; Headache; Hyperhidrosis; Hypokalaemia; Laboratory test abnormal; Myalgia; Pyrexia; Shoulder pain; Sleep disorder; Vaccination complication; White blood cell count increased	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0227300	10/04/2004	AL	54.0	53		F	10/01/2004	Redness, swelling, pain from elbow to shoulder after pneumonia shot. Also fever, aching and inability to hold food in stomach.									Y	09/29/2004	09/30/2004	1		OTH	PVT		NONE				1						1	Abdominal pain; Injection site erythema; Injection site oedema; Injection site pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~41448AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0864N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0227301	10/04/2004	CA	14.0	14		M	10/01/2004	Modified pox preceded by mild temp elevation at onset.									Y	09/17/2004			NONE	PVT	UNK	NONE	NONE	NONE			1						1	Pyrexia; Viral infection	FLU3~SANOFI PASTEUR~U1417AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1031M~UNK~~RA~HEP B (RECOMBIVAX HB)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~767A2~UNK~~LA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~0190P~UNK~~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0227302	10/04/2004	NJ	5.0	5		F	10/11/2004	Pt received Fluzone .5ml 10/29/2003 and had a 1st time afebrile seizure 11/8/03. Developed fever 11/9/03. CT neg, EEG neg. Received DTaP/ MMR 5/27/04 and had 2nd afebrile seizure 6/10/04. MRI neg. Started on Depallete. No further seizures. Follow Up: Seizure, No fever at time of event. Now on Depakote.				Y					Y	05/27/2004	06/10/2004	14	CT neg, EEG neg, MRI neg, FH x seizures.	PVT	PVT		NONE	pulmonary valve stenosis, Arteriol Switch Operation procedure (2)			1						1	Convulsion	DTAP~SANOFI PASTEUR~C1696AA~5~~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1097AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0959N~2~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0227337	10/04/2004	PA	46.0	46		F	10/04/2004	Soon after vaccine, my arm that injection given became uncomfortable, like there was a tournaquet around my arm, then my arm became heavy and sore, I had tingling in my right arm and my right leg, I went to the emergency room that night, I had a CVA.  I reported this to the nurses at Occupational medicine, but I'm not sure that an adverse event form was filed. Follow UP: Pt states left arm and leg affected.  Nurse follow up on 10/30/04 states: cerebellar infarct; Subcortical ischemic change. Follow up 01/26/05: I continue to have numbness and tlingling along with imtermittent heavey feeling in left arm and leg. My balance is also affected, I loose my balance very easily.				Y	Y	3		Y	N	11/06/2003	11/06/2003	0	MRI, CT brain, other labs; lab test abnormal;	UNK	UNK	Enilapril	Recovering from CVA from October 2003.	Hypertension; migraine; hypercholesterolemia; mitral valve prolapse;			1						1	Balance disorder; Cerebral infarction; Cerebral ischaemia; Hypoaesthesia; Laboratory test abnormal; Pain; Paraesthesia; Sensation of heaviness	FLU3~EVANS VACCINES~765958~UNK~~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0227338	10/04/2004	CO	79.0	78		F	10/04/2004	About 32 hours after receiving the vaccine, I started to itch severely all over my body.				Y					Y	10/01/2004	10/03/2004	2		UNK	UNK						1						1	Pruritus	FLU3~SANOFI PASTEUR~U1440AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227344	10/05/2004	VA	81.0			M	10/01/2004	I got GBS on 8/29/02. Diagnosed as GBS in hospital. Now in a rental assisted living home. Hope to be walking soon. Follow up 01/20/05: Still under on going medical care, has not recovered. I' good as I can be. I fell good, no aches or pains. The only thing to complain about I gues is that I can't make the right knee do what its supposed to do. I can't get either leg to pull up like their supposed to do. Neith leg hurts, I just can't lift both of them as far or as high as I should. The left one is nealy normal but not so for the right. I can't get either leg to lift up as far as it should in a single step. On I can get the left on up pretty good but the right one is hard. Also, I can't get them up on the second step very easily. I guess I could get it up a second step but boy what a task. My back is ok, arms ok, breathing ok and talking seems to be ok. I am having soem trouble with my eyes. My right eye might as well be blind as I can only see everything as a blear. Stuff just wont focus in the right eye. The left eye is pretty much ok. I need my old glasses to make out stuff, but I can read the newspaper with my glasses in the left eye if I'm careful and try hard. In the right eye I'm having troube, it just doesn't focus good. Rougly speaking however it's functioning pretty well. I have to have drops in bother eyes to see fairly well. When I look at airplanes in the sky, there are two airplaines separated by a bit of space. I guess that's double vision. I can make a airplane disappear however by blocking the vision to the right eye!!! Lets see you do that!! I am walking down and back 150 foot corridor with my walker all by myself. I can get in and out of the car without any help, but I'm not sure how much more I can do. Information from Discharge summary states respiratory failure, ataxia, infection, dyspnea, weak, eye disorder and venous thrombophlebitis. Medical records state sepsis, constipation, bells palsy, abnormal thinking, pneumonia.  msv			Y	Y	Y	360	Y	Y	N		08/29/2002		GBS Medical records state abnormal EKG, abnormal lab tests. msv	PUB	PVT		NONE	NONE Medical records state hypertension, diabetes mellitus, disc disease and hypercholesteremia. msv			1						1	Apnoea; Asthenia; Constipation; Coordination abnormal; Dyspnoea; Electrocardiogram abnormal; Eye disorder; Facial palsy; Guillain-Barre syndrome; Infection; Laboratory test abnormal; Pneumonia; Sepsis; Thinking abnormal; Venous thrombosis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0227346	10/05/2004	GA		6		M	09/17/2004	Screaming with back pain x 5-10 minutes. Same reaction following last years flu shot. Child recovered without any additional s/s.									Y	09/17/2004	09/17/2004	0		PVT	PVT						1						1	Back pain; Screaming; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U1383AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227347	10/05/2004	KS	78.0	77		F	10/01/2004	Influenza injection administered at 09:20 on 10/01/2004 immediate reaction arm devloped redness at site and bump or knot developed measuring about 2.5cm.									Y	10/01/2004	10/01/2004	0		PVT	PVT			Penicillin, Codeine=rash , GI upset			1						1	Injection site erythema; Injection site mass	FLU3~SANOFI PASTEUR~U1496AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227349	10/05/2004	NJ	46.0	45		F	09/30/2004	Systemic cutaneous reaction with erythema and urticaria. No wheezing. No upper respiratory distress.				Y					Y	09/30/2004	09/30/2004	0	NONE	PVT	PVT	Synthroid, Cardiazem, Flonase	NONE	Asthma, Hypothyroidism, Mitral valve prolapse			1						1	Erythema; Urticaria	FLU3~SANOFI PASTEUR~U1383AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227394	10/06/2004	NC	67.0	66		M		This subject is a 67 year old male who was admitted to the hospital and died while enrolled in a study. The subject received two doses of RSV vaccine or Placebo and Influenza vaccine. The last dose prior to the event was given on 10/23/03. The subject was hospitalized for a stomach mass, date of hospitalization not reported. While in the hospital subject developed a blood clot and died 334 days post immunization on 9/21/04. The subject's death due to a blood clot was reported by the investigator as unknown in relationship to the study vaccine.  Follow up on 10/08/04 states: There was no autopsy done for this decedent.  Nurse follow up on 10/14/04 states: pulmonary embolism; deep vein thrombosis.  Nurse follow up on 10/19/04 states: small bowel mass.  Nurse follow up on 11/11/04 states: fat necrosis of the mesentery with partial small bowel obstruction.	Y	09/23/2004			Y				N	10/24/2003	09/23/2004	335		UNK	UNK	Vitamin C, E, B complex; Testosterone injections; Slo K; Maxide; Lasix; Acupril; Zyloprim; ASA;		Received a dose of RSV vaccine or Placebo and Influenza vaccine. Administration date not reported. Blood pressure high; Hypertension; Congestive Heart Failure; Osteoarthritis; wac degenerative; Left orchiectomy in 2002;		200403234	1						1	Deep vein thrombosis; Gastrointestinal necrosis; Gastrointestinal neoplasm; Intestinal obstruction; Pulmonary embolism; Thrombosis	FLU3~SANOFI PASTEUR~U1137HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0227398	10/06/2004	KY	2.0	2	.1	F	10/05/2004	Large (about 1.75 by 2) red area of redness and mild induration right thigh at the site of DTaP vaccine.									Y	10/04/2004	10/05/2004	1	NONE	PVT	OTH	Singulair; Claritin; Pulmicort; Amoxicillin	Pharyngitis; RAD	RAD			1						1	Injection site erythema; Injection site induration	DTAP~SANOFI PASTEUR~U1290CA~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U11496AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE340AA~4~IM~LL~HIB (ACTHIB)~1	USA		Influenza
0227399	10/06/2004	FL	3.0	2	1	F	10/03/2004	Child awakened from nap on 9/29/04; unable to move legs and difficulty moving arms, wincing in pain. Evaluation in ER revealed fever 101.7 with subsequent regression post Motrin of most of symptoms. 9/30/04 Pain linked to injection site.				Y					Y	09/29/2004	09/29/2004	0	NONE	PVT	PVT		Rhinitis	NONE			1						1	Hypokinesia; Injection site pain; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U411AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227405	10/06/2004	MN	44.0	44		F	10/06/2004	Extreme sweating, dizziness, temperature, left side arm, neck and fingers were numb, headache, and fast heart beat.									U	10/05/2004	10/05/2004	0		UNK	UNK		None - slight cough	None			1						1	Dizziness; Headache; Heart rate increased; Hyperhidrosis; Hypoaesthesia; Pyrexia	FLU3~SANOFI PASTEUR~U1440AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227406	10/06/2004	CO	56.0			F	10/06/2004	Got shot at noon 10/05/04; Very tired early evening; woke up at 2:40 AM very HOT and damp. My bedroom is not heated, so is about 50degrees; all i could tolerate was a sheet up to my waist. I was that hot all night. I had nightmares; very vivid; caused anxiety; very shaky and weak this morning with lack of concentration; fingers don't seem to want to work.									Y					UNK	UNK	Celexa, Estradril, Vicodin, Xanax, Ambien Seroguel		Depression, Panic Attack			1						1	Anxiety; Asthenia; Disturbance in attention; Fatigue; Feeling hot; Hypokinesia; Nightmare; Tremor	FLUX~UNKNOWN MANUFACTURER~U1440AA~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0227439	10/07/2004	PA	75.0	74		M	09/30/2004	Soreness at site of injection, erythema. Temperature 102. Now 98.5. Felt warm and lethargic. Staring day after injection. Erythema 7x6 cm left deltiod arm. BP 104/60. Acetomenophin advised.									U	09/28/2004	09/29/2004	1		PVT	PVT	Prevacid	NONE	NONE			1						1	Erythema; Feeling hot; Injection site pain; Lethargy; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~V1411~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0371P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0227473	10/07/2004	CA	4.0	4		F	09/29/2004	The day after vaccine was given pt developed redness, color, induration, tenderness and itching.									U	09/27/2004	09/28/2004	1		PVT	PUB	NONE	NONE	NONE			1						1	Injection site erythema; Injection site mass; Pruritus; Skin discolouration; Tenderness	DTAP~SANOFI PASTEUR~U12900A~5~IM~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U152AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X0771~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1069N~3~IM~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0227509	10/07/2004	TX	57.0	57		F	10/07/2004	Afternoon of 10/3/04, developed hives. I began taking Benadryl every 6-7 hrs which controlled itching somewhat. Afternoon of 10/5/04, eyes began feeling scratchy/puffy and were slightly swollen. Morning of 10/6/04, eyes, earlobes, face, neck were severly swollen. Doctor administered two shots, prescribed Prednisone (20mg 3X's daily, and to take Benadryl (25-50mg every 6 hrs for a least 4-6 more doses).				Y					U	10/02/2004	10/03/2004	1		UNK	UNK	InnoPran XL & Etodolac		Lower back pain			1						1	Eye irritation; Eye swelling; Face oedema; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~U1496AA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0227512	10/07/2004	TX	49.0	49		F	10/07/2004	Developed 30 minutes of chills, nausea and 1 episode of vomitting.  Occurred about 12 hours post vaccination.  Seen in clinic next day 10/7/04.  Feels sore/sick.  No rash or fever Has tolerated flu shot in previous years without consequence									Y	10/06/2004	10/06/2004	0	Temperature 97.4F	UNK	UNK	None	None	None			1						1	Chills; Malaise; Myalgia; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U1496AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227514	10/07/2004	PA	61.0	61		F	10/07/2004	PATIENT C/O FEELING VERY WEAK THE MORNING AFTER HER VACCINE.  LASTED ABOUT 8 HOURS.  DENIED ANY OTHER ABNORMAL SYMPTOMS.									Y	10/05/2004	10/06/2004	1	NONE	UNK	UNK	NONE	NONE	PENICILLIN			1						1	Asthenia	FLU3~SANOFI PASTEUR~U1442AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227516	10/07/2004	NJ	52.0	51		F	10/07/2004	metallic taste in mouth beginning approx 20 hours after vaccine administration and lasting approx 5 days taste alteration (most food tasted bitter)beginning approx 20 hours after vaccine administration and continuing									N	10/01/2004	10/02/2004	1		UNK	UNK	Zocor	none	hypercholesterolemia			1						1	Dysgeusia	FLU3~SANOFI PASTEUR~U1455CA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227518	10/07/2004	WA	57.0	56		F	10/07/2004	Received Influenza vaccine on 10/5/04.  Noted that the next day had swollen area at injection site.  Injection site is red and warm with induration measuring 58mm transverse and 40mm vertically.  States it was throbbing.									U	10/05/2004	10/06/2004	1		UNK	UNK						1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~VJ0404K~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227505	10/08/2004	CA	32.0	32		F	10/04/2004	Pt states she developed a severe headache about 8PM on day she received flu shot. Continued throughout weekend- denies other sx-H/A resolving also c/o fatigue which is resolving.									Y	10/01/2004	10/01/2004	0		OTH	PVT	NONE	NONE	NONE			1						1	Fatigue; Headache	FLU3~SANOFI PASTEUR~U1426AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227506	10/08/2004	PA	7.0	7		M	09/29/2004	Fever 102, diarrhea, vomiting, hives on face, several hive like lesions, at site of shot, 4x1 cm diameter blotchy painful. Problem on right arm.				Y					Y	09/27/2004	09/28/2004	1		PVT	PVT	Zyrtec	Abdominal pain, dizziness	Allergic to amoxicillin, syncope			1						1	Diarrhoea; Injection site pain; Injection site reaction; Pyrexia; Rash macular; Skin ulcer; Urticaria; Vomiting	FLU3~SANOFI PASTEUR~U1418AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0530N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0227508	10/08/2004	AK	76.0	75		M	10/07/2004	One day after receiving Pneumovax 23 injection right arm (deltoid) the pt noticed right anterior upper arm to be bright red, hot to feel and swollen. 2nd day after RC for eval reported arm very improved, less red, no swelling, not hot. The pt never had pain or fever. The redness never came within 7cm of injection site. reaction was distal to injection. Tx. started with anti-inflammatory cream, pt declined.									Y	10/05/2004	10/06/2004	1	NONE	OTH	UNK	Pt on Lisinopril, Pletal, Metoprolol	NONE	HTN, VD Cord		AK200459	1						1	Erythema; Feeling hot; Oedema	FLU3~SANOFI PASTEUR~U1381AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0869N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0227568	10/08/2004	CO	63.0	63		F	10/08/2004	ONSET OF REDNESS, SWELLING OF LEFT ARM APPROX. 12 HOURS AFTER ADMINISTRATION. BY 24 HOURS, LEFT ARM FROM SHOULDER TO BELOW ELBOW WAS RED, TENDER. EVALUATION ON 10/7/2004 AT 1700 AT A MEDICAL FACILITY BY MD. RX IV ANCEF. REQUIRED ED EVAL 10/7/2004 PM AND EVAL.AGAIN AT ACUTE INJURY AND ILLNESS ON 10/8/2004 FOR IV ABX. CHANGED TO ORAL ABX 10/8/2004 AND RE-EVALUATION EXPECTED IN 48 HOURS.				Y					U	10/06/2004	10/06/2004	0		UNK	UNK	LISINOPRIL ESTRADIOL ASA	NO	HYPERTENSION ALLERGY: BACTRIM			1						1	Erythema; Oedema; Tenderness	FLU3~SANOFI PASTEUR~u1451AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0987N~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0227569	10/08/2004	NJ	0.4	0	.4	F	10/08/2004	10 h after vaccination:  extreme nausea and severe headache.  In the morning, the headache continued.									Y	10/07/2004	10/07/2004	0		UNK	UNK	none	none	none			1						1	Headache; Nausea	FLU3~SANOFI PASTEUR~~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227570	10/08/2004	IN	39.0	38		F	10/08/2004	Received flu shot at approx. 2:30 pm on 10/7/04. At 5:30 am on 10/8/04 ankles, feet and injection site swollen.  Pitting edema of ankles and feet. Reported to Employee Health and instructed to go to Work Med for full evaluation by Nurse Practioner.									U	10/07/2004	10/08/2004	1		UNK	UNK		None	Allergies to Penicillin and erythromycin.  Hypothyroidism and reflux.			1						1	Injection site oedema; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0227573	10/08/2004	TX	24.0	24		F	10/08/2004	25 year old female received anthrax vaccine #1 in the right arm and smallpox vaccine in the left arm on 21 Oct 03.  Three days later she developed left clavicle pain, like a bruise.  She noted a bump at the site of the pain.  For approximately three months after receipt of the first anthrax dose, her left shoulder would ache when she ran.  She received the second anthrax vaccine 20 Jan 04.  She had a large, red bump and a bruise that did not extend beyond the elbow for approximately 1 ½ to 2 weeks.  The site was warm and tender for the entire 1 ½ to 2 weeks and she did not go to the gym during this time due to the discomfort.  The third dose was given 12 Feb 04.  Within 2 days she was diagnosed with an ear infection and upper respiratory infection.  She also had a local reaction that was not as severe as the previous reaction.  This local reaction was present for about four days.  She currently has no symptoms, but is concerned about continuing the anthrax series and developing other symptoms.									Y	10/21/2003	10/24/2003	3	28 Apr 04 - CT chest with contrast:  no abnormality identified by CT in the area of clinical concern.  Consider follow-up with a targeted ultrasound.	MIL	MIL	none	none	none			1						1	Arthralgia; Contusion; Erythema; Injection site reaction; Injection site warmth; Laboratory test abnormal; Otitis media; Pain; Skin nodule; Tenderness; Upper respiratory tract infection; Vaccine positive rechallenge	ANTH~EMERGENT BIOSOLUTIONS~FAV076~1~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1270AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020071~1~ID~LA~SMALLPOX (DRYVAX)~1	USA		Influenza
0227575	10/08/2004	WI	66.0	65		F	10/08/2004	Patient states had increased temp and vomiting, swelling and redness on 10/01/2004, after receiving vaccines.  Arm painful, red and swollen for 2 days. States still taking tylenol #2 tabs every 6 hours.  Arm redness decreased and not as swollen.  Will observe.									Y	10/01/2004	10/01/2004	0	n/a	UNK	UNK	cozar 25mg a.m. zoloft 100mg in am, 50mg in pm dilantin 100mg in am and pm mirtazapine 30mg 1 in p.m. synthroid .125 in a.m. prevacid .15mg 1 in a.m.	n/a	seizure disorder and allergic to sulfa			1						1	Erythema; Oedema; Pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~u1410ba~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0946n~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0227577	10/08/2004	WA	46.0	45		F	10/08/2004	States that she receieved influenza vaccine on 10/06/04 at 0753.  At 1600 noted hives on trunk.  States that at 2000 had about 15 pruritic maculopapular lesions on trunk mostly on back.  Took Benadryl 25mg at HS and stated that by 10/8/04 rash is mostly gone except where she scratched lesions.   States she did not make any changes in her diet or take any new foods or use any new skin care products or soaps or laundry detergent.  States that she had varicella as a child and has a positive titer.   States that she does not have a history of an egg allergy and that she has taken the flu shot regularly in the past.									Y	10/08/2004	10/08/2004	0	none at this time	UNK	UNK		none				1						1	Pruritus; Rash maculo-papular; Urticaria	FLU3~SANOFI PASTEUR~U1378AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227579	10/09/2004	MO	32.0	31		M	10/08/2004	10/06/04 - Received flu vaccine at work at ~9AM.  Arm was sore by end of day. 10/07/04 - Developed fatigue by 4:30PM.  Explosive diarrhea at 8PM.  Minor sneezing and tingling sensation throughout body by 10PM.  Entire nasal passage blocked with congestion by 11PM.  Difficulty sleeping throughout evening. Body sensitive to blankets at times, and seem painful to the touch.  10/08/04 - Severe headache by 7AM.  Ingested 800mg of ibuprofen at 7AM and able to sleep until 12PM the same day.  Explosive diarrhea at 3:15PM. Increase in sneezing and mucous production and collected temperature with 97.5 degrees Fahrenheit.  Watery diarrhea episodes throughout evening.									U	10/06/2004	10/07/2004	1		UNK	UNK	Effexor XR 150mg/day	None	Penicillin Nalfon Doxycycline Tetracycline			1						1	Diarrhoea; Fatigue; Headache; Hypersensitivity; Insomnia; Myalgia; Nasal congestion; Pain; Paraesthesia; Sneezing	FLU3~SANOFI PASTEUR~U1418AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227581	10/09/2004	OH	69.0	68		F	10/09/2004	10:00 am 10/06 hands started itching. No sign of rash or hives at this time, just itching. Starting in the evening approx. time 7:00 pm had started itching. Continued into Thursday morning. After 10:00 am started itching on various parts of body. No signs of rash or hives. Thursday night 10/7 about 6:00pm saw hives around waist. Itching incresed. Called doctor 8:00pm, told to start taking 25mg Benadryl. Friday morning 10/08 started itching intensely,more hives appeared. Called the doctor, was given a prescription for Predenisone 10mg to be taken on a tapered method, six the first day-five the second day-four the third day etc.   During the night Friday 10/08 the hives and rash started spreading all over ..eyes started swelling...at 8:00 am Saturday morning 10/09 went to the emergency dept.  Given three shots by IV.benadryl-zantac-don't remember the third. Was told these three injections help for hives. Given a prescription for 150mg of Zantac to be taken twice daily for five days. Released from hospital at 10:30am and told to make appointment with family doctor.				Y					N	10/04/2004	10/06/2004	2	blood test .results were normal.	UNK	UNK	synthroid100 mg.-one a day..percocet 5-325mg.--three a day--aspirin 3.25-one a day.					1						1	Eyelid oedema; Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U1448AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227557	10/11/2004	CA	61.0	61		U		Fever 101, sore throat, muscle aches, running nose, neck ache, slight stomach upset. 24 hours follow up vaccination. Still symptoms present at 83 hours.									N	10/05/2004	10/06/2004	1	NONE	PUB	OTH	NONE	NONE	NONE			1						1	Abdominal pain upper; Myalgia; Neck pain; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1381AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227558	10/11/2004	TX	41.0	41		F	10/07/2004	Pt complained of feeling bad and her blood pressure was high. She thought it may have been because she started a new blood pressure medication. She was also broken out with a rash.				Y					N	10/06/2004	10/07/2004	1	NONE	OTH	OTH	Cartiaxt; Low-ogestrel; Paroxetine; Vicodin; Lodibutrin XL; Inderal LA;	High Blood Pressure; Depression;	High Blood Pressure; Depression;			1						1	Hypertension; Malaise; Rash	FLU3~SANOFI PASTEUR~W440AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227559	10/11/2004	VI	76.0	76		M	10/08/2004	15 -20 minutes after the administration of Flu and Td shot given in same area per my request, left arm. Experienced lightheadedness, leg weakness and radiating left arm pain. Pt advised to inform of any complications. Pt at home, BP was 113/76. Today 10/18/04 experienced symptom of tingles in left arm.									U	10/07/2004	10/07/2004	0	NONE	PUB	OTH	UNK	Hypertension; Polycystic kidney; History of melanoma;	Hypertension; Polycystic kidney; History of melanoma;			1						1	Asthenia; Dizziness; Injection site pain; Paraesthesia	FLU3~SANOFI PASTEUR~U1419AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~AVENTIS PASTEUR~U1025AA~UNK~~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0227560	10/11/2004	CO	3.0	2	.8	M	10/07/2004	Redness, swelling, warmth right deltoid.				Y					U	10/05/2004	10/06/2004	1	UNK	PUB	OTH	Zyrtec;	NONE	Seasonal allergies; Asthma;			1						1	Injection site erythema; Injection site oedema; Injection site warmth	DTAP~SANOFI PASTEUR~C1606AA~UNK~~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1418AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227561	10/11/2004	TN	40.0	39		F	09/30/2004	Pt called to say she became lightheaded and had a headache an hour after injection. She also had site tenderness and shoulder and backache. About 12 hours later complained of fever 101.6, chills, aches all over. Taking Tylenol every 4-6 hours. Has no fever 48 hours later but still aches.									N	09/28/2004	09/29/2004	1	NONE	OTH	OTH	States had taken Tylenol prior to vaccine administration to reduce injection site side effects.	NONE	NONE			1						1	Back pain; Chills; Dizziness; Headache; Pain; Pyrexia; Shoulder pain	FLU3~SANOFI PASTEUR~U1380AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227562	10/11/2004	MT	68.0	68		M	10/04/2004	Redness at site of injection-drifting down arm to below crook of elbow on medial aspect. Swelling accompanied redness, no temperature AM of 10/04. Right deltoid (pneumococcal) problem site.				Y					U	10/01/2004	10/02/2004	1	UNK	OTH	OTH	Numerous;	Cold; Fever or acute;	UNK			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1451AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0987N~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0227563	10/11/2004	NE	1.02	1	.0	M	10/04/2004	17 erythematous macular-papular lesion with some vesicular formula-erythematous base-consistent with varicella.									U	09/10/2004	09/29/2004	19	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Dermatitis bullous; Drug ineffective; Erythema; Rash maculo-papular	FLU3~SANOFI PASTEUR~41410BA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1070N~UNK~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~495724~UNK~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1315N~UNK~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0227564	10/11/2004	WV	38.0	38		F	10/04/2004	Redness, itching, swelling at site (left deltoid). Redness spread across chest, back, right arm. Blood pressure increased, nauseated. (Blood pressure measurement). Benadryl/pain medication at hospital. Medical records add pain, vasodialation. msv				Y					Y	10/01/2004	10/01/2004	0	BP measurement;	PUB	PVT	Wellbutrin; Hydrocodone;	NONE	NONE			1						1	Hypertension; Injection site erythema; Injection site oedema; Nausea; Pain; Pruritus; Vasodilation procedure	FLU3~SANOFI PASTEUR~U14UAA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227591	10/11/2004	MI	4.0	4		F	10/02/2004	11 cm diameter area of erythema and induration. Problem area on left thigh.									Y	09/28/2004	09/29/2004	1	NONE	UNK	PVT						1						1	Erythema; Injection site induration	DTAP~SMITHKLINE BEECHAM~614C9~5~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1383AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X0777~4~IM~LL~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0227612	10/11/2004	LA	41.0	41		M	10/11/2004	Low Grade Fever, Weakness, Fast Heart Rate, Dizziness, Behavior Change(anger/short temper), Low Back Pain, Sharp Head Ache at left eye and forehead.									Y	10/08/2004	10/08/2004	0		UNK	UNK	Currently taking, but not prescribed by Physicin listed above; Aderal XR 15mg., Lexapro 5mg., O/C Sinus & Allergy medications	Seasonal Allergies, Sinus Congestion	Adult ADD, Chronic Sinusitus			1						1	Abnormal behaviour; Anger; Asthenia; Back pain; Dizziness; Headache; Heart rate increased; Pyrexia	FLU3~SANOFI PASTEUR~U1380AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227614	10/11/2004	MA	18.0	17		F	10/11/2004	Severe aching of head, neck and back followed by weakness of arms and legs.  This started 24 hours after the shot and has continued for 5 days.  Physical exam and neurologic examination is completely normal.									U	10/07/2004	10/08/2004	1	none	UNK	UNK	ibuprofen only after symptoms developed	none	none			1						1	Back pain; Headache; Muscular weakness; Neck pain	FLU3~SANOFI PASTEUR~U1498AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227615	10/11/2004	TX	51.0	51		F	10/11/2004	swollen, red, sore, felt hot Pt taking ibuprofen and applying ice when felt hot									U	10/09/2004	10/09/2004	0		UNK	UNK						1						1	Erythema; Feeling hot; Pain; Swelling	FLU3~SANOFI PASTEUR~U1418AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227628	10/12/2004	CA	62.0	61		M	10/11/2004	Severe sore throat ~24 hr. post IM flu vaccination.  Difficult swallowing and esophageal burning sensation with anything swallowed, including cool purified H2O.  Fatigue.  Lethargy.  No nausea, dizziness, vomiting or syncope.  Mild photophobia.  No fever or chills.  Single night sweat.  Vaccinated 6pm Pacific time Oct. 4, 2004.  Now, after 7 symptomatic days, throat shows only slightest improvement while pain seems to move down oesophagus and out eustachian tubes.				Y					N	10/04/2004	10/05/2004	1	Throat swab of meaty tissues at back of mouth were negative for Strep. Other (Unknown but possible relevance):  Pt presented ~1 wk before vaccination w. moderate diarrhea persistent for 7 days onset of which Pt reported occurred within 1 hr. of eating suspicious fish at a local restaurant.  Stool sample eventually negative for O&P, Vibrio, & tested bacterial orgs., including salmonella & E. coli.  (Diarrhea resolved w.o. antibiot. therapy about a week after flu shot and onset of sore throat.)  Pt also reports finishing a 5 d course of 5ml q 12 hr of dexamethasone elixir to abort at prodrome onset buccal apthous sores to which Pt is very prone (>12 exacerbations/yr. for last 7 yrs w. increased freq. in most recent 2 yr period).  Pt had been using acyclovir for control of buccal sores which had been Dx-d as herpetic.  To ensure renal integrity (after years of antiviral therapy - variously episodic or prophylactic w Valtrex), BUN & Creatine were assayed by sample drawn the day of flu vaccination.  Both values were within normal bounds.	UNK	UNK	none current at time of vaccination	diarrhea (see above)	Bell's Palsy (paralysis onset April 1993), Gilbert's Syndrome, Codeine, Horse Serum, Tetanus anti-Toxoid, Celebrex, VIOXX.  Otherwise, excellent health.			1						1	Aphthous stomatitis; Diarrhoea; Dysphagia; Fatigue; Lethargy; Night sweats; Oesophageal pain; Pharyngolaryngeal pain; Photophobia	FLUX~UNKNOWN MANUFACTURER~U1410BA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0227629	10/12/2004	CA		51		F		Rash, pin point and red, began in antecubital space of left arm. Then spread body wide; itchy soles of feet. No wheezing.									N	10/06/2004	10/07/2004	1		UNK	UNK	L-Carnitine	NONE	HTN: Allergic to tea, dust mites.			1						1	Erythema; Pruritus; Rash	FLU3~SANOFI PASTEUR~U1443AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227632	10/12/2004	OH	4.0	4		F	10/12/2004	redness and warmth at injection site/ fever of 103. Received Omnicif.									Y	10/11/2004	10/11/2004	0	pt with pos. uti	UNK	UNK		possible UTI	spina bifida			1						1	Injection site erythema; Injection site warmth; Pyrexia; Urinary tract infection	FLU3~SANOFI PASTEUR~U1421AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227633	10/12/2004	MD	42.0	41		F	10/12/2004	Received influenza vaccine in a.m. After lunch, noticed slight burning/tingling sensation to skin. Didn't notice any rash. No itching. Arrived home about 5 p.m., changed clothes and noticed rash on chest & shoulders (like red lace). Took Benadryl 50mg and was less red in a few hours. This has never happened after a flu shot before.				Y					Y	10/05/2004	10/05/2004	0	None	UNK	UNK	Zoloft, Altace, Ultram, Cataflam, Lasix, K-dur, Singular, Advair, Proventil, Flonase, Glucophage, Lipitor, Benadryl	None	Hyperlipidemia, hypertension, MVP, fibromyalgia.			1						1	Erythema; Paraesthesia; Rash; Thermal burn	FLU3~SANOFI PASTEUR~U1454AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227636	10/12/2004	KY	56.0	55		M	10/12/2004	TERRIBLE PAIN IN LEFT ARM FIRST DIAGNOSED AS CERVICAL DISC, LEFT HAND NUMBNESS WITH M.  Nurse follow up on 11/01/04 states: There is no new information.									U	10/09/2003	10/23/2003	14	MRI, NEUROPATHY WORK-UP  DIAGNOSED AS BRACHIAL NEURITIS REPORTED TO PLACE OF INJECTION. MUSCLE ATROPHY IN BOTH LIMBS AND SHOULDERS	UNK	UNK	PAXIL, CARDIZIEM, LIPITOR,SINGULIAR	NONE	HEART CONDITION(POST MI), ASTHMA			1						1	Hypoaesthesia; Muscle atrophy; Pain; Radiculitis brachial	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0227639	10/12/2004	TX	10.0	9		F	10/12/2004	Received injection at 3:30 pm on October 11, 2004.  Apx 3 hours later injection site was red, very swollen, very hard and hot.  Same thing happened last year.  Doctors office told us to give Benadryl every 6 hours.									Y	10/11/2004	10/11/2004	0		UNK	UNK				same as flu shot this year, extremely swollen, hard, hot, painful~Influenza (Seasonal) (no brand name)~~8.80~In Patient		1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth; Similar reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~U1488AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227640	10/12/2004	TX	73.0	73		F	10/12/2004	Dizziness in the evening for about an hour.....took Tylenol.									U	10/08/2004	10/08/2004	0		UNK	UNK		NONE	Nothing to cause dizziness.  Take Fosamax.			1						1	Dizziness	FLU3~PFIZER\WYETH~U144TAA~UNK~~UN~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0227641	10/12/2004	NJ	58.0	57		M	10/12/2004	Vaccine given appx. 11 a.m. 10/08/04. Arm very sore, unable to raise it by 1:30 p.m.; large red area of swelling where injection was given. By 7:00 p.m. tiredness set in with fever and severe swelling of entire upper arm with heat eminating from area. Patient wanted to sleep and rest, but  the wife wouldn't let him and finally convinced him he needed medical attention by appx. 9:00 p.m. Emergency walk-in med. center (EMO) diagnosed edema and cellulitis at site of injection, with temp. of appx. 101. Injection given of Rocephin and antibiotic; 2 Motrins; 2 antihistamines. Instructions to return the next day for re-check. At this time on 10/09/04, swelling and redness still present,still unable to raise arm, but no fever. Prescriptions given for 10 days of Prednisone and 10 days of oral antibiotics. EMO requested 3 day follow-up on 10/12/04; swelling is reduced, temp. is normal,and patient has full use of arm.  Follow up on 10/18/04 states: Right deltoid problem site.				Y					Y	10/08/2004	10/08/2004	0		UNK	UNK	pravachol, zetia, baby aspirin	none	blocked coronary artery			1						1	Cellulitis; Fatigue; Feeling hot; Injection site hypersensitivity; Injection site swelling; Joint range of motion decreased; Oedema peripheral; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1442AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0944N~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0227646	10/13/2004	KS	1.3	1	.3	M	10/11/2004	Complex febrile seizure; fever. Discharge Summary received on 1/3/2005 states lethargy. Medical Record received on 1/3/2005 states viral inflammatory process.					Y	2			Y	10/08/2004	10/09/2004	1	CT Head; Blood; Urine; CSF culture; Spinal Tap	PVT	PVT	NONE	NONE	Asthma			1						1	Febrile convulsion; Lethargy; Pyrexia; Viral infection	FLU3~SANOFI PASTEUR~U1410BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A6718CB~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0227649	10/13/2004	VA	5.0	4		F	10/05/2004	Pt developed hives generalized all over body, but no anaphylaxis, no allergy, no difficulty breathing. Pt still active, alert, responsive.									Y	10/04/2004	10/04/2004	0		PVT	PVT		Head lice, URI	Asthma, Atopic dermatitis			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1409BA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227650	10/13/2004	MI	14.0	14		M	10/01/2004	Injection site-Erythematous-indurated 3x4 inches and painful. Ipsilateral axilla swollen and tender, with anterior axillary fold swollen. Pt describes numbness and tingling in axilla and right anterior chest wall.				Y					Y	09/29/2004	09/30/2004	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Hypoaesthesia; Injection site erythema; Injection site mass; Injection site pain; Oedema; Paraesthesia; Tenderness	FLU3~SANOFI PASTEUR~U1442AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227651	10/13/2004	IN	1.52	1	.5	F	10/05/2004	18 hours after injection of vaccines developed hives over entire body.									N	09/30/2004	10/01/2004	1		PVT	UNK	Tylenol 1 tsp, Benadryl 3/4 tsp.	NONE	NONE			1						1	Urticaria	DTAP~SANOFI PASTEUR~C1698AA~4~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1383AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1189~3~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|PPV~PFIZER\WYETH~A74399C~4~IM~LL~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0227702	10/13/2004	PA	9.0	8		F	10/13/2004	approx. 20 hours after flu shot my daughter has temperature of 99.3, headache, back ache and arm ache(where shot given)  Given Motrin but still having symptoms									N	10/12/2004	10/13/2004	1		UNK	UNK		none	none			1						1	Back pain; Headache; Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~U1383AA~1~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227703	10/13/2004	VA	53.0	53		F	10/13/2004	Employee states she felt soreness and a knot in her arm at injection site 2 days after vaccine injection.  Then 2 - 3 days later she felt pain starting near injection site, going down her arm.  She states that her right ring and pinky fingers feel like they are going numb.  She states there is no change in skin temperature or color of the fingers.  As of the date of this report, the employee states she has not sought medical care for the problem.  She states she has had carpal tunnel in that same extremity before.									U	09/30/2004	10/01/2004	1	None done to this date.	UNK	UNK	Atacand Prilosec (over the counter)	Employee denied any allergies or illnesses.	Hypertension Reflux	States got very sick with flu symptoms~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Hypoaesthesia; Injection site mass; Injection site pain	FLU3~SANOFI PASTEUR~U1377AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227704	10/13/2004	TX	25.0	25		F	10/13/2004	After receiving the Flu Vaccination, felt nauseous and an odd sensorium occured a few minutes after administration.  Pt. did not fall or lose consciousness.  Pt. also had same symptoms last after receiving the Flu Vaccine, it was attributed to a hot crowded room where vaccine was administered.  Pt also had a Tetanus/ Diphtheria vaccine about month prior without any reaction or symptoms.									Y	10/08/2004	10/08/2004	0	N/A	UNK	UNK		N/A	N/A	nauseous & light headed~Influenza (Seasonal) (Fluzone)~~0.00~In Patient		1						1	Depressed level of consciousness; Nausea	FLU3~SANOFI PASTEUR~U1438AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227709	10/13/2004	TN	3.0	3		M	10/13/2004	~20 minutes after vaccine was given pt was not fell asleep and would not wake up easily.  Grandmother states that this lasted for ~20 minutes. Upon arrival to office he was sleepy but arousable with normal VS. Within 10 minutes he was normal.									Y	10/13/2004	10/13/2004	0	none	UNK	UNK	none	none	Febrile seizures			1						1	Depressed level of consciousness; Somnolence	FLU3~SANOFI PASTEUR~U1380AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227710	10/13/2004	WA	52.0	52		F	10/13/2004	Received flu vaccine on 10/12/04 at 0830.  On 10/13/04 at 1530 noted maculopapular rash at injection site.  Rash covers area about 60mm by 100mm at injection site on L arm.  It is irregular and does not cover entire site.  States it is not itchy.  Does not have any respiratory symptoms.  Denies egg allergy and eats eggs regularly.  Has had flu shot for the last 6 years.  Had varicella as a child.  Has not changed laundry soap, soaps, lotions, or new medications.  Has not had any new foods.									Y	10/12/2004	10/13/2004	1		UNK	UNK	Celexa, atenolol,bcp, zocor	none	augmentin, lipitor, seasonal allergies, mold, cats, cows, tobacco			1						1	Injection site rash; Rash maculo-papular	FLU3~SANOFI PASTEUR~U1456AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227711	10/13/2004	FL	30.0	29		F	10/13/2004	I am a very healthy person in good shape and a good size. I have never had an adverse reaction to any vaccines before. I have always thought it was best to get vaccines. I will never feel that way again. Within two minutes of receiving the vaccine I became very nauseous. I had the vaccine administered at about 12:30PM. I am a teacher and worked until 4PM. I went home and continued to feel very nauseous and by 9PM I began having pain in my abdomen that radiated from my stomach and spread upwards and down. I also got a severe headache. It became so severe that I could only breathe very slightly. If I moved at all or laid on my left side the pain was so severe it made me very concerned for my health. My lymph nodes began to swell by 11PM the same day all over my body even in my arms. They hurt and became red. This scared me as it had never happened before! Saturday I had the same difficulty breathing, and my entire abdomen still hurt. I was very weak. My insurance is not in effect or normally I would have went to the ER at that point. I have a high pain tolerance and this was a 10 when I moved or breathed deep on a scale of 0 to 10 with 10 being the worst. Sat. night I was concerned I was getting pneumonia. I laid down in the bed on my left side and terrible pain filled my entire body cavity. I painfully turnmed over on my right side and laid very still. As long as I barely breathed I was ok. I told my husband that if I get better as the night goes on I will not go into the ER but if I get worse at all from this point on or do not get better by the wee hours of the night when one of us usually gets up to use the restroom that I will want him to bring me to the ER. Thankfully about 4AM I awoke and I could lay on my left side the same as I could on the right with no pain as long as I didnt move. With movement I still had severe pain. This continually got better at a very slow rate until 11PM Sunday night when all the pain was gone and my lymph nodes began to go down in sixe and redness. I will never again in my life get the flu vaccine or have my husband or three children get it. I really believed I was going to get pneumonia rapidly and die. I am not a worrier and I did not express this previous thought to my family.									Y	10/08/2004	10/08/2004	0		UNK	UNK		None				1						1	Abdominal pain; Asthenia; Erythema; Headache; Hyperventilation; Lymphadenopathy; Nausea	FLU3~SANOFI PASTEUR~U1383AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227712	10/14/2004	MN	80.0	80		M	10/11/2004	From initial information received from a health care professional on 10/7/04 regarding an adverse event occurring in the USA, it was reported that an 80 year old male patient with a history of cardiac problems and prostate cancer received a FLUZONE vaccination, lot number U1380AA, administered in the right deltoid on 10/7/04. One hour after receiving the vaccine, the patient died in his car in the hospital parking lot. Per the reporter, the coroner's initial impression was that it may have been a coronary heart attack and he stated that he would check for this. No other information was provided at this time. There was no autopsy done.  Nurse follow up on 10/19/04 states: No new information.  Follow up on 10/28/04 states: From additional information received on 10/21/04, it was reported that the pt had no illnesses at the time of vaccination. He received the FLUZONE SV '2004-2005 vaccination IM. He had previously received at least 3 or more influenza vaccines in the past without experiencing any adverse events. His previous medicaitons had included amlodipine, atorvastatin, atenolol, digoxin, furosemide, nitrates, lisinopril and metformin. His current medication list was not available at the time of this report, so it is unknown if the pt was taking any of these medications at the time he received the influenza vaccine on 10/07/04.	Y	10/07/2004							N	10/07/2004	10/07/2004	0		PVT	PVT	Lupron; Atenolol; Imdur; Actos; Digoxin; Aspirin; Norvasc; Furosemide; Lisinopril; Zocor		The patient had a history of unspecified cardiac problems and prostate cancer. He had previously received influenza vaccines in 2002 and 2003, and a Pneumovax vaccine in 2003. Nurse follow up on 10/14/04 states: Diabetes Type II; Myocardial Infarct 2000; aortic stenosis; ischemic cardiomyopathy. From additional information received on 10/21/04, it was reported that the patient had no illnesses at the time of vaccination. He had previously received at least three or more influenza vaccines in the past without experiencing any adverse events. His previous medications had included amlodipine, atorvastatin, atenolol, digoxin, furosemide, nitrates, lisinopril, and metformin. His current medication list was not available at the time of this report, so it is unknown if the patient was taking any of these medications at the time he received the influenza vaccine on 10/7/04. From additional information received on 11/8/04, it was reported the patient's medical history included coronary artery disease with myocardial infarction in 10/00, triple coronary arter bypass, ischemic cardiomyopathy, aortic stenosis, prostate cancer, cataract extraction with intraocular pressure, total hip arthroplasty in 1993 and adult onset diabetes mellitus. Patient's previous medications included Imdur, Actos, Atenolol, Digoxin, Aspirin, Norvasc, and Furosemide all taken every morning. Evening medications included Atenolol, Lisinopril and Zocor.		200403324	1						1	Myocardial infarction	FLU3~SANOFI PASTEUR~U1380AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0227718	10/14/2004	MO	1.51	1	.5	F	10/13/2004	Child ran a low grade temp T max 101 degrees the day after given the shot. Baseball sized noticed bump.				Y					Y	10/11/2004	10/13/2004	2	NONE	PVT	PVT	NONE	NONE	Amoxicillin			1						1	Injection site induration; Pyrexia	DTAP~UNKNOWN MANUFACTURER~C1693AA~4~~RL~DTAP (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~01476AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227719	10/14/2004	CO	5.0	4		F	10/01/2004	3 x 3 red, warm, swollen area.									Y	09/29/2004	09/30/2004	1		PVT	PVT						1						1	Erythema; Feeling hot; Swelling	FLU3~SANOFI PASTEUR~U137488~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227720	10/14/2004	KS	70.0	70		M	10/06/2004	Approximately 1 hour after receiving the vaccine: left back pain kidney area, them moved to front; chills fore hip bone 10/6/04 belly is hurting. Frequent BMS; feels much better									Y	10/04/2004	10/04/2004	0	NONE	PUB	PUB	A5A, Sotalol Multi-vitamin, Zoloft, Coumadin	Runny Nose	CHF Pulmonary fibrosis	reaction unevaluable~Influenza (Seasonal) (no brand name)~~56.00~In Patient		1						1	Abdominal pain upper; Back pain; Chills; Renal pain; Similar reaction on previous exposure to drug; Skin burning sensation	FLU3~SANOFI PASTEUR~U1380AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227721	10/14/2004	CA	66.0	65		F	10/07/2004	Onset of chills and pain at site. Redness and swelling at injection site. Approximately 4cm x 10cm. Treated with Keflex.									Y	10/04/2004	10/05/2004	1	NONE	PVT	PVT			Rheumatoid arthritis, HTN, GERD, OJD			1						1	Chills; Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U13799AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0740N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0227722	10/14/2004	OH	74.0	74		F	10/07/2004	Patient received both pneumonia and flu shot. She fainted at stores. Vital signs stable. Patient also said pain at injection site that tingle down back. Patient admitted to not eating much that day and had previous problems with hypoglycemia.  Follow up on 10/18/04 states: Problem at Pneumovax site.									Y	10/04/2004	10/05/2004	1	Vital signs fine.	UNK	UNK						1						1	Hypoglycaemia; Injection site pain; Paraesthesia; Syncope	FLU3~SANOFI PASTEUR~U1448AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0896N~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0227723	10/14/2004	NV				M	10/05/2004	Developed hives in extremities 7 days after vaccination, then spread to neck. 3 days later with persistent receiving hives, he also developed shortness of breath, hence brought to ER.				Y					Y	09/20/2004	09/26/2004	6		PVT	UNK		NONE	Arthrogryposis			1						1	Dyspnoea; Urticaria	FLU3~SANOFI PASTEUR~U1378AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227765	10/14/2004	MD	57.0	56		M	10/14/2004	Received flu shot at 0630, 10/12/04.At 1300, felt flushed in face like he had a fever. Felt worse all afternoon. At 1830, chills began and he shook hard and it continued until 0200 10/13/04 when his fever broke. Later the same day he began getting small bumps/raised rash the size of a finger tip on his arms, back and right leg. This morning, 10/14/04, all that remained was a soft ball sized patch of flat red rash on his buttock.  After showering this morning, the rash was gone. All of the rashes itched.									Y	10/12/2004	10/12/2004	0	None	UNK	UNK	Zocor, Calan, Centrum Silver	None	Resolved (due to weight loss)  hyperlipidemia and hypertension--is to continue taking medications for them.			1						1	Chills; Flushing; Pruritus; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U1454AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227768	10/14/2004	WA	65.0	65		F	10/14/2004	On 10/06/04 received influenza vaccine at 0745.  Five hours later noted tingling in injection arm-superior surface of forearm.  Noted Maculopapular pruritic rash at this site.  At HS noted generalized tingling over entire body.  Noted urticaria around R ankle.  Took cool showers and soda baths for relief.  Buzzing and tingling sensation in ears and general has continued to date.  States is sensitive to meds and has limited Benadryl use.  Denies allergy to eggs.  Has not changed laundry soaps, or sking products.  Has had varicella as child.  Is currently not sick and no children in familly are sick.  No new medications.									Y	10/06/2004	10/06/2004	0		UNK	UNK	Norvasc and maxide.  Has been on these medications for a long time.	none	Demerol			1						1	Paraesthesia; Pruritus; Rash maculo-papular; Tinnitus; Urticaria	FLU3~SANOFI PASTEUR~u1456AA~UNK~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227769	10/14/2004	IL	46.0	46		F	10/14/2004	The evening and day following the immunization I did have a fever, my arm was warm and sore, which I expected. On Sunday the 10th, I was having itching on my chest at the tops of my breasts and around the anal/vaginal area.  It has gotten worse in the last few days, and has spread from the tops of my ears to my thighs.  I went to see the doctor at the clinic yesterday the 13th- I have no rash, no hives, no visible signs or symptoms.  I am not allergic to eggs, nor have I started any new medications, until now- now I am on prednisone and vistaril.  I have not changed my eating habits and I have not changed any soaps, detergents, etc.  As far as I know I have not been exposed to any other compounds or poisons, have not been in any weeds or anywhere. I do not think they have been spraying for anything.  The only thing I could think of was exposure to a scabies patient about a month or so ago, but I do not have a rash, and the scraping that the doctor took from my skin was negative.  My husband does not have any itching and he did not get a flu shot.  Other than us, we have some house pets, but they are not having any problems either, and they don't hang outside for long.  When they are, they are confined to our back yard and we have not been spraying for anything either.  I have been racking my brain since this all came about and this is the only thing that I can think of that was different about my life and surroundings.				Y					U	10/05/2004	10/10/2004	5	Skin scraping for scabies- negative	UNK	UNK	I take lexapro 10mg and clarinex 5 mg. These are drugs that I have taken for some time- well over a year.  I also take Co-Q-10.	none	allergic rhinitis/sinusitis- hayfever-  perimenopausal- take lexapro for depression/anxiety Sporanox causes hives and itching, levaquin and codiene cause itching- but not as bad as this is.  Exposed to diethylstilbestrol in utero, 1958.			1						1	Feeling hot; Pain; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~U380AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227770	10/14/2004	VA	65.0	64		F	10/14/2004	Client received Pneumovax on 10/12/04.  On 10/13/04 the client's husband called and stated the arm was swollen.  I stated that was a normal local reaction.no other symptoms were reported.  I asked the client to use ice packs and Tylenol, if not contraindicated, and was told if no improvement in 48 hrs. to call me. On 10/14/04 the client presented herself to the HD.  Left upper arm from midline to elbow was red,edematous, raised and warm to touch. Client stated it was moving more toward elbow.  The redness wrapped half around arm. The client stated it was painful 10/13/04 but better today. No other symptoms noted or complained. Due to the acute swelling and the client being immuned compromised, I called her walk in clinic she frequents. An appointment was made for today,(10/14/04)									U	10/12/2004	10/13/2004	1		UNK	UNK	Advair, Flonase, Celebrex, Albuterol, Allegra	none	Fibromyalgia, asthma			1						1	Erythema; Feeling hot; Oedema peripheral	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0257N~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0227772	10/14/2004	OR	28.0	28		F	10/14/2004	Pneumonia vaccine administered afternoon of 10/12/04. Patient awoke at 3am 10/13/04 gasping for air and noticed small rash 3in. below inj site. Woke in A.M. with palm-sized erythema & hardness in same area. Took Zyrtec at that time. Presented to me at ~11A.M. 10/13/04 in no apparent respiratory distress. I told her to go to doctor asap for follow-up. Per pt: Bullseye at shot site 4 hrs later, 8 hrs after shot generalized rash on arm with swelling. Took Benadryl PO saw her allergist 10/13/04 who advised no additional medication-use ice to site of Pneumovax. Some progression of swelling rash thru 10/14. Better on 10/16/04, continues with brusing on arm, pain almost gone				Y					Y	10/12/2004	10/13/2004	1		UNK	UNK	Singulair, Zertec, Claritin, Pulmacort, Atrole, Lidseapeate, Floradil, Desogen, Ferocet, Rinocort, Norflex, Backrin	none - healthy subject	Multiple allergies, asthma, environmental allergies, Hx of pneumonia x2 in 1 season.			1						1	Contusion; Dyspnoea; Injection site erythema; Injection site induration; Oedema; Rash	FLU3~SANOFI PASTEUR~U1440AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0947N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0227773	10/14/2004	GA	72.0	72		M	10/14/2004	Tuesday Oct. 13 04 at 2:30 pm I received my Flu shot about 4 hrs later I began to have chills and then fever, felt weak. I covered up after lying down. After about 16 - 18 hrs the flu like symptoms subsided and I began to feel back to normal. Just wanted to submit this info for your benefit.									Y	10/12/2004				UNK	UNK						1						1	Asthenia; Chills; Influenza like illness; Pyrexia	FLU3~SANOFI PASTEUR~U1440AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227774	10/14/2004	OR	0.51	0	.5	F	10/14/2004	Urticaria over chest and back.  No respiratory distress.  Symptomatic care and referral to allergist recommended.				Y					Y	10/14/2004	10/14/2004	0		UNK	UNK	None	Upper respiratory infection.	None			1						1	Urticaria	DTAP~SANOFI PASTEUR~C1996AA~3~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1390AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0332P~2~IM~RL~HEP B (RECOMBIVAX HB)~1|HIBV~SANOFI PASTEUR~UE246AB~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A74399E~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0227775	10/14/2004	CA	13.0	12		F	10/14/2004	At approximately 9:15 am on 10/12/04 the flu vaccine was administered.  Patient states that as soon as she recieved the injection her right eye began to burn.  She did not notify the nurse because she did not realize it was due to the injection.  Her Grandfather took her to school after that.  During the school day the tissue around the right eye became red and began to swell.  When I came home from work at 6pm her eyelid above the eye was extremely swollen.  The tissue below the eye was also extremely swollen and dark.  I gave her 25mg of Benadryl at 6pm and another 25mg at 10pm.  The next morning,(10-13-04)the swelling around her eye came down but the tissue was still slightly swollen.  Underneath her eye the tissue became bruised.  I took her in to her Pediatrician to have the reaction documented in her chart.  As of today 10-14-04 the swelling is almost completely gone however the tissue underneath the right eye has a bruise approximately 2cm long and 0.5cm wide.									Y	10/12/2004	10/12/2004	0		UNK	UNK			Septra, asthma			1						1	Contusion; Eye irritation; Eye swelling; Eyelid oedema; Ocular hyperaemia	FLU3~SANOFI PASTEUR~U1463AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227778	10/15/2004	NJ	5.0	4		M	11/23/2004	From initial information received from a health care professional through a manufacturer's sales force representative on 10/6/04 regarding an adverse event occurring in the USA, it was reported that a child (no specific information provided), received INFLUENZA VACCINE on 9/17/04. The manufacturer, lot number, route and site of administration were not reported. Ten days later, on 9/27/04, the patient presented to the physician with bruising. Blood work was drawn and showed a decreased platelet count. The patient was subsequently diagnosed with idiopathic thrombocytopenia purpura. The patient's recovery status is currently unknown. From additional information received on 29Oct04 through a telephone call to the responsible physician, the office fax number was provided by a nurse at the facility. No additional information relevant information was provided for the adverse experience. This follow up information is not submitted to the health authorities. From additional information received on 22Nov04 from a health care professional, it was reported that the pt was a five year old male who received his fifth dose of Fluzone SV 2004-2005 USP vaccine, lot number U1383AA, administered IM in the arm on 16Sep04. Reportedly seven days later, on 23Sep04, the pt developed idiopathic thrombocytopenic purpura. The pt had no signs of the idiopathic thrombocytopenic purpura prior to the vaccination. His platelet count was 3,000. The pt reportedly recovered by 07Oct04. No further information is anticipated, this case is considered closed.				Y					Y	09/16/2004	09/23/2004	7	The patient was reported to have a decreased platelet count, however, no results were provided. From additional information received on 22Nov04: Platelet count was 3,000.	PVT	PVT			The patient had a mild upper respiratory infection at the time of vaccination. From additional information received on 22Nov04: it was reported that the pt has a past medical history of asthma. He has no allergies to food or medications.		200403313	1						1	Platelet count decreased; Thrombocytopenic purpura	FLU3~SANOFI PASTEUR~U1383AA~5~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227779	10/15/2004	VA	13.0	12		M		This is a serious case from a consumer whose son developed JUVENILE RHEUMATOID ARTHRITIS, considered medically significant, after receiving FluMist (OMIC). The reporter did not provide causality between events and FluMist vaccine. A mother reports her son developed juvenile rheumatoid arthritis, considered medically significant, after receiving FluMist. On 23Dec03, a 12 year old male received FluMist and in mid January, his knee became swollen. When he was taken to the doctor they gave him a temporary diagnosis of juvenile rheumatoid arthritis. The JRA has progressed symmetrically into his hands, knees, toes, and jaw. He went back to the doctor in early September 2004. He had a positive ANA test and was diagnosed with polyarticulate JRA. The patient has not recovered. Lot number is unknown and additional information has been requested. Additional information received from mother on 26Oct04 incorporated into above narrative. Follow up 03/14/05: Patient has not recovered from the adverse event(s). Stiffness of joints with less swelling and pain his jaws. A VAERS follow up report was submitted in accordance with 21CFR600.80. 04/26/2005 Per the reporter, the patient continues to have swelling and pain in his joints but the severity is less.  The patietn's white blood cell count also dropped below normal.  The drop in WBC count is being attributed to his methotrexate intake.  The WBC count will be reported next week.  Currently, his WBC is 4.									N	02/01/2004			ANA positive 02/09/04	OTH	OTH	NONE		Patient's brother and both parents also received FluMist with no unusual symptomatology.		MEDI0002264	1						1	Joint swelling; Laboratory test abnormal; Oedema peripheral; Rheumatoid arthritis	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0227788	10/15/2004		54.0			F	10/08/2004	Information has been received from a health care worker concerning a 54 year old female who on 9/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Concomitant therapy included influenza virus vaccine, it was unknown when the flu shot was given. On 9/30/04, the patient developed lymph node swelling and fever. The patient was seen in the emergency room. It was also noted that the patient was hospitalized. At the time of the report, the patient had not recovered. The reporter expressed concern with lot 0740N. The reporter also mentioned 4 other female patients who were also vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed similar reactions. No product quality complaint was involved. Lymph node swelling and fever were considered to be immediately life-threatening and disabling. Additional information has been requested. Follow up 03/03/05: Patient has not recovered from the adverse event(s).			Y	Y	Y		Y	Y	Y	09/28/2004	09/29/2004	1	UNK	OTH	OTH			UNK		WAES0410USA00906	1						1	Lymphadenopathy; Pyrexia; Lymphadenopathy; Pyrexia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0740N~UNK~IM~~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0740N~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0227789	10/15/2004		67.0			F	10/08/2004	Information has been received from a health care worker concerning a 67 year old female who on 9/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Concomitant therapy included influenza virus vaccine (unspecified), it was unknown when the flu shot was given. On 9/30/04, the patient developed lymph node swelling and fever. It was noted that one patient had gone to the emergency room. It was also noted that the patient was hospitalized. The outcome was not recovered. The reporter also mentioned 4 other female patients who were also vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N) and developed similar reactions. No product quality complaint was involved. Lymph node swelling and fever were considered to be immediately life-threatening and disabling. Additional information has been requested.  Follow up on 10/18/04 states: Information has been received from a health care worker concerning a 67 year old female who on 09/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Suspect concomitant therapy included influenza virus vaccine (Fluzone), on the same arm, which was administered on the same day.  On 09/29/04, the pt developed lymph node swelling and fever. The pt was seen in the ER. It was also noted that the pt was hospitalized. At the time of the report, the pt had not recovered. The reporter expressed concern with Lot 0740N.  Lymph node swelling and fever were considered to be immediately life-threatening and disabling. Additional information has been requested. Follow up 03/03/05: Patient has not recovered from the adverse event(s).			Y	Y	Y		Y	Y	Y	09/28/2004	09/30/2004	2	UNK	OTH	OTH			UNK		WAES0410USA00907	1						1	Lymphadenopathy; Pyrexia; Lymphadenopathy; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0740N~UNK~~~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0740N~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0227790	10/15/2004		60.0			F	10/08/2004	Information has been received from a health care worker concerning a female patient in her late 60's who on 9/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Concomitant therapy included influenza virus vaccine (unspecified), it was unknown when the flu shot was given. On 9/30/04, the patient developed lymph node swelling and fever. It was noted that one patient had gone to the emergency room. It was also noted that the patient was hospitalized. The outcome was not recovered. The reporter also mentioned 4 other female patients who were also vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N) and developed similar reactions. No product quality complaint was involved. Lymph node swelling and fever were considered to be immediately life threatening and disabling. Additional information has been requested.  Follow up on 10/18/04 states: Information has been received from a health care worker concerning a female pt in her late 60's who on 09/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Suspect concomitant therapy included influenza virus vaccine (Fluzone), in the same arm, which was administered on the same day. On 09/29/04 the pt developed lymph node swelling and fever.  The pt was seen in the ER. It was noted that the pt was hospitalized. At the time of the report, the pt had not recovered. The reporter expressed concern with Lot 0740N.  Lymph node swelling and fever were considered to be immediately life-threatening and disabling. Additional information has been requested. Follow up 03/03/05: Patient has not recovered from the adverse event(s).			Y	Y	Y		Y	Y	Y	09/28/2004	09/30/2004	2	UNK	OTH	OTH			UNK		WAES0410USA00909	1						1	Lymphadenopathy; Pyrexia; Lymphadenopathy; Medication error; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0740N~UNK~IM~~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0740N~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0227791	10/15/2004		68.0			F	10/08/2004	Information has been received from a health care worker concerning a 68 year old female who on 9/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Concomitant therapy included influenza virus vaccine (unspecified), it was unknown when the flu shot was given. On 9/30/04, the patient developed lymph node swelling and fever. It was noted that one patient had gone to the emergency room. It was also noted that the patient was hospitalized. The outcome was not recovered. The reporter also mentioned 4 other female patients who were also vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N) and developed similar reactions. No product quality complaint was involved. Lymph node swelling and fever were considered to be immediately life-threatening and disabling. Additional information has been requested.  Follow up on 10/18/04 states: Information has been received from a health care worker concerning a 68 year old female who on 09/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Suspect concomitant therapy included influenza virus vaccine (Fluzone), in the same arm, which was administered on the same day. On 09/29/04 the pt developed lymph node swelling and fever.  The pt was seen in the ER. It was noted that the pt was hospitalized. At the time of the report, the pt had not recovered. The reporter expressed concern with Lot 0740N.  Lymph node swelling and fever were considered to be immediately life-threatening and disabling. Additional information has been requested. Follow up 03/03/05: Patient has not recovered from the adverse event(s).			Y	Y	Y		Y	Y	Y	09/28/2004	09/30/2004	2	UNK	OTH	OTH			UNK		WAES0410USA00908	1						1	Lymphadenopathy; Pyrexia; Lymphadenopathy; Medication error; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0740N~UNK~IM~~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0740N~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0227792	10/15/2004		70.0			F	10/08/2004	Information has been received from a health care worker concerning a 70 year old female who on 9/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Concomitant therapy included influenza virus vaccine (unspecified), it was unknown when the flu shot was given. On 9/30/04, the patient developed lymph node swelling and fever. It was noted that one patient had gone to the emergency room. It was also noted that the patient was hospitalized. The outcome was not recovered. The reporter also mentioned 4 other female patients who were also vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed similar reactions. No product quality complaint was involved. Lymph node swelling and fever were considered to be immediately life threatening and disabling. Additional information has been requested.  Follow up on 10/18/04 states: The pt was seen in the ER. It was also noted that the pt was hospitalized.  At the time of the report, the pt had not recovered. The reporter expressed concern with Lot # 0740N.  Lymph node swelling and fever were considered to be immediately life-threatening and disabling. Additional information has been requested. Follow up 03/03/05: Patient has not recovered from the adverse event(s).			Y	Y	Y		Y	Y	Y	09/28/2004	09/30/2004	2	UNK	OTH	OTH			UNK		WAES0410USA00063	1						1	Lymphadenopathy; Pyrexia; Lymphadenopathy; Medication error; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0740N~UNK~IM~~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0740N~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0227796	10/15/2004	MI	3.0	3		M	10/13/2004	Increased sleep on 10/9. Patient slept most of the day. The following morning (10/10), patient awoke with emesis one time and around 2 PM, patient had ataxic gait that progressed to inability to stand.  Nurse follow up on 10/30/04 states: anorexia.				Y	Y	3			U	10/06/2004	10/10/2004	4	MRI head negative; CSF fluid negative.	PVT	PVT	Amoxicillin	URI	NONE			1						1	Anorexia; Coordination abnormal; Gait disturbance; Somnolence; Vomiting	FLU3~SANOFI PASTEUR~U1418AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0227797	10/15/2004	FL	0.63	0	.6	F		Myoclonic jerks to left arm and had evaluation for seizures.  Nurse follow up on 10/30/04 states: benign myoclonus.				Y	Y	1			Y	10/05/2004	10/09/2004	4	24 hour video EEG; CT Scan; Electrolytes.  lab values abnormal	PVT	PVT	NONE	NONE	NONE			1						1	Dyskinesia; Laboratory test abnormal; Myoclonus	FLU3~SANOFI PASTEUR~U1452AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0227798	10/15/2004	NC	5.0	4		M	10/11/2004	Severe localized reaction to left arm (erythema, warmth)									Y	10/09/2004	10/10/2004	1		PVT	PVT		URI	Asthma			1						1	Erythema; Feeling hot	FLU3~SANOFI PASTEUR~U145AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227799	10/15/2004	NJ	2.0	2	.4	F	10/12/2004	5x4 cm area redness, warmth and tenderness. Started Sunday 10/10 (received vaccine 10/9). Seen by PMD 10/11/2004. Treated with Keflex.				Y					Y	10/09/2004	10/10/2004	1		PVT	PVT	Zyrtec	NONE	Seasonal allergies/ RAD			1						1	Erythema; Feeling hot; Tenderness	FLU3~SANOFI PASTEUR~41409BA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227800	10/15/2004	KY	33.0	33		F	10/08/2004	Red reaction 13cm x 8cm, hot to touch with patient having nausea with vomiting. Pt also had two syncope episodes over. Pt had onset of red reaction to site, nausea with vomiting and syncope within 1 hr. Anaphylaxis reaction, MD Rx Benadryl Epi, Vistiril, Nomec PO meds.  Nurse follow up on 10/30/04 states: Verbal record: anaphylaxis.  Nurse follow up on 11/01/04 states: anaphylaxis; hypervent; confused; weak; dizzy.				Y					Y	10/08/2004	10/08/2004	0		PUB	UNK		NONE	NONE			1						1	Anaphylactic reaction; Asthenia; Confusional state; Dizziness; Erythema; Feeling hot; Hyperventilation; Nausea; Syncope; Vomiting	FLU3~SANOFI PASTEUR~U1380AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227801	10/15/2004	CA	72.0	71		F	10/12/2004	Felt chills, cold, soon afterwards threw up once then diarrhea started (watery, 15 times thru Sunday) no fever at any time and then dissipated slightly. Head felt heavy. Less on Sunday. Monday felt better had a couple of meals, today diarrhea is trying to stop.									N	10/09/2004	10/10/2004	1		UNK	PUB	Insulin, Ferris sulfate, Nexium, Nitrodur, Lasix, Cinthoid Lopid, Zocor, Fivex, Diavon, Caviduro	NONE	Diabetes, high blood pressure,e hernia, esophageal reflux			1						1	Chills; Decreased appetite; Diarrhoea; Head discomfort	FLU3~SANOFI PASTEUR~U1449AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227802	10/15/2004	TN	65.0	64		M	10/14/2004	Pt complained of numbness in left arm starting around 2 hours after immunization. Still painful more than 1 week later causing loss of sleep.									U	10/05/2004	10/05/2004	0		UNK	PVT						1						1	Hypoaesthesia; Insomnia; Pain	FLU3~SANOFI PASTEUR~U144DAA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0386P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0227823	10/15/2004	WA	41.0	41		F	10/15/2004	Received vaccine on 10/13/04 at 0815.  States had soreness at injection site immediately.  On 10/14/04 in the evening noted swelling and heat on dorsal aspect of L upper arm from area of injection site to elbow.  Area is errythematous and warm to touch currently.   Denies new medications, new skin care products, laundry soap, or new foods.  States has been afebrile.  Has never had a vaccine reaction to previous vaccines.									Y	10/13/2004	10/14/2004	1		UNK	UNK	Estrogen, multivitamin	none	no other allergies			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1456AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227824	10/15/2004	TX	77.0	77		F	10/15/2004	DIZZY ALL DAY 10-08-2004. TOOK QTY. 1 MECLIZINE TAB. OK NEXT DAY!									Y	10/07/2004	10/08/2004	1		UNK	UNK						1						1	Dizziness	FLU3~SANOFI PASTEUR~U1440AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227826	10/15/2004	MI	34.0	34		F	10/15/2004	3-6 hours post injection, hives, pruritis, and mild SOB developed.  Left arm (injection site) became very swollen and indurated and warm.  Benadryl and prednisone dispensed and most symptoms abated except still pruritis at injection site.  Nurse follow up on 10/30/04 states: Nausea; vomiting; allergic reaction.				Y					Y	10/12/2004	10/12/2004	0	None	UNK	UNK	Advair diskus 500/50	none	asthma; allergy;			1						1	Dyspnoea; Hypersensitivity; Injection site induration; Injection site swelling; Injection site warmth; Medication error; Nausea; Pruritus; Urticaria; Vomiting	FLU3~SANOFI PASTEUR~U1445AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227827	10/15/2004	OH	25.0	24		F	10/15/2004	20-40 minutes after injection, pt experienced nausea & vomiting; dizziness, itching, pallor. No rash, no dyspnea. Rec'd in ED: Benedryl 50mg IV, Solu Medrol 125mg IV, Tagamet 300mg IVpb.  After-wards developed chest tightness.  Vital signs throughout within normal limits.  Sent home on Benedryl as needed orally.				Y					Y	10/14/2004	10/14/2004	0	N/A	UNK	UNK	Nuprin	No known	No known Allergies Hx of Endometriosis			1						1	Chest discomfort; Dizziness; Nausea; Pallor; Pruritus; Vomiting	FLU3~SANOFI PASTEUR~U1383AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227830	10/15/2004	OR	68.0	68		F	10/15/2004	Severe headache, palpitations lasted about 20 min.									U	10/14/2004	10/14/2004	0		UNK	UNK		none				1						1	Headache; Palpitations	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0227832	10/15/2004	CA	50.0	50		M	10/15/2004	Got Fluzone shot on 10/4.  1-2 days later got ache on left side of my neck.  On Sat. 10/9, got a cold or flu.  Bad part lasted two days.  Started with raw throat coughing out blood streaks in sputum.  Muscle ache, weakness, raw throat, coughing, headache, stuffy nose.  Fever got up to  101. On third day, got better.  Fever went down to 99 and started sweating.  Took cough syrup (with codeine) a few times for cough. Drank ample water, soup, tea..  Info of of receipt: Rx#6619739   Tx#1038840   Auth:T90410043LWM11 Fluzone 2004  Inj Aven  NDC:49281-0374-15									Y	10/04/2004	10/06/2004	2	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Cough; Haemoptysis; Hyperhidrosis; Myalgia; Nasal congestion; Neck pain; Pharyngitis; Pharyngolaryngeal pain; Pyrexia; Rhinitis	FLU3~SANOFI PASTEUR~U1504AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227833	10/15/2004	TX	67.0			F	10/15/2004	About 45 minutes after the injection, I started itching.  It began on my feet and then spread to my waist area and then hands.  My face was very flushed and I felt warm.  The person in charge had my blood pressure checked and gave me two Benadryl caps and told me not to play anymore tennis that day and wait another 30 minutes to be checked again. I did so and then went home---took a cool shower and ate lunch. Soon after I began to have chills and period of warmth (no temp)and an a general ache all over felling.  I called my doctor and was told that the Benadryl was a good remedy and I took some more and 2 Tylenol caps and took a nap---I was red from head to toe and itched all over the rest of the day.  The next morning, the red was starting to fade and the itching gradually subsided. By the following day I was almost completly normal except for a little itching.									Y	10/07/2004	10/07/2004	0		UNK	UNK						1						1	Chills; Feeling hot; Flushing; Pain; Pruritus	FLU3~SANOFI PASTEUR~U1458AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227835	10/15/2004	OR	78.0	77		F	10/15/2004	Severe Fatigue Medical records state fever, short of breath, tachycardic. msv					Y	2			Y	10/12/2004	10/13/2004	1	Unknown- pt was dehydrated Medical records state abnormal lab tests. msv	UNK	UNK		None	Medical records state hypertension, renal artery stenosis, dyslipedema, aortic stenosis, allergy. msv			1						1	Dehydration; Dyspnoea; Fatigue; Laboratory test abnormal; Pyrexia; Tachycardia	FLU3~SANOFI PASTEUR~u1440aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0227837	10/17/2004	MD	6.0	6		F	10/17/2004	The shot was adminstered on October 11.  Usual symptoms followed such as tiredness, and low grade fever.  However, by the 2nd day following the shot, fevers were common about every 6 hours.  Fever ranged from 99.5 to 103.2.  This is still going on as I type.  High fevers and almost 6 days since the shot was given.				Y					U	10/11/2004			Simple exam was given on Thursday, 14.  This included a urine exam.  Then throat culture, another urine exam and blood work were done on Saturday, 16.  No results as of yet.	UNK	UNK			Allergies (hayfever, slight asthma)			1						1	Fatigue; Pyrexia	FLUX~UNKNOWN MANUFACTURER~APU1418AA~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0227839	10/17/2004	VA	1.57	1	.6	F	10/17/2004	High fever, lethargic behavior after 4 days  - lasted approx 24 hours Broke out in rash covering entire body after 1 week - rash remains after 24 hours									U	10/08/2004	10/12/2004	4		UNK	UNK		None	None			1						1	Lethargy; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U1403AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227841	10/17/2004	WA	62.0	62		F	10/17/2004	Received vaccine at approximately 2:00 P.M. Friday Oct.15, 2004. After dinner that evening about 8:00 P.M. acute indigestion occurred along with nauseousness, chills, feverish and general discomfort along with a runny nose.  Sat. the symptoms were lessened, however I awoke with a headache and continue to have a slight neck strain.  This morning, Sunday morning I had loose bowels and some stomach discomfort.  I continue to have a slight neck tightness and a general feeling of discomfort.  I was able to eat breakfast and am feeling okay so far.									U	10/15/2004	10/15/2004	0		MIL	UNK	Coumadin, HCTZ, Potassium, Zocor, Flonase, Albuterol, Combivent, Advair					1						1	Abdominal pain upper; Chills; Diarrhoea; Discomfort; Dyspepsia; Headache; Nausea; Neck pain; Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1501AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227843	10/17/2004	OR	69.0	68		M	10/17/2004	In the evening of 10/14/04 pt had swelling and erythema of rt arm from shoulder almost to elbow with presence of rash at outer margins. No changes in breathing were reported.									Y	10/14/2004	10/14/2004	0		UNK	UNK	none reported	none	a-fib, hypercholesterolemia			1						1	Injection site erythema; Injection site swelling; Rash	FLU3~SANOFI PASTEUR~u1440aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0947n~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0227850	10/18/2004	GA	52.0	51		F	10/15/2004	10/13/04 Employee received influenza vaccine. 10/14/04 she reported to me 8AM on 10/14. Sx itching, whelps, raised red areas over body including scalp. Escorted to ER. Solumedrol injection and Benadryl injection sent home with Rx for Zyrtec.				Y					N	10/13/2004	10/13/2004	0		PUB	PVT		Palpitation, osteoporosis, hypothyroidism	Sulfa			1						1	Pruritus; Rash erythematous; Urticaria	FLU3~SANOFI PASTEUR~U1440AA~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227851	10/18/2004	IA	64.0	64		M	10/15/2004	Mouth pain with tingling and numbness in the tongue, neck pain, dizziness, low grade fever				Y					Y	10/14/2004	10/14/2004	0	NONE	PVT	PVT		NONE	HTN, hypercholesterolemia, BPH, Biliary disease			1						1	Dizziness; Hypoaesthesia; Neck pain; Oral pain; Paraesthesia; Pyrexia	FLU3~SANOFI PASTEUR~U1378AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227852	10/18/2004	IN	39.0	39		F	10/15/2004	Per pt: Approx 1 hour after injection had chills, fever, H/A, nausea, didn't feel sharp in head.									U	10/08/2004	10/08/2004	0		PVT	PVT	NONE					1						1	Chills; Headache; Nausea; Pyrexia; Sedation	FLU3~SANOFI PASTEUR~U1410BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227853	10/18/2004	TX	69.0	68		F	10/09/2004	Fever +100 redness of skin, slightly swollen, no pain. Pt is ok. Come by on 10/7/04 all ok.									Y	10/04/2004	10/05/2004	1		OTH	UNK						1						1	Erythema; Oedema; Pyrexia	FLU3~SANOFI PASTEUR~U1440AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0513P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0227854	10/18/2004	TX	65.0	65		M	10/08/2004	Local swelling at injection site with induration, blister formation, pain, warmth, fever and chills within 24 hours of injection. Tx: Acetaminophen/ cold compress/ Allegra/ dexamethasone IM 4mg.									U	10/05/2004	10/06/2004	1		PVT	UNK		Allergic Rhinitis	Asthma, Neuropathy			1						1	Blister; Chills; Feeling hot; Injection site mass; Injection site oedema; Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~U1496AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0664N~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0227855	10/18/2004	NC	0.59	0	.6	M	10/07/2004	High fever>103 x 48-77 hours, fussiness				Y					Y	09/29/2004	09/30/2004	1	UA blood nl, Unrecx. neg, 394>11.7/34.4<17.3 WBC, 65% Lymphs, 31% Polys.	PUB	PUB	NONE	URI x 10 days	NONE			1						1	Irritability; Pyrexia	DTAP~SANOFI PASTEUR~U1300BA~3~~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1439AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0334P~3~~LL~HEP B (RECOMBIVAX HB)~1|HIBV~SANOFI PASTEUR~UE167AA~3~~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~495705~3~~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0227896	10/18/2004	GA	54.0	53		M	10/18/2004	Fever 101.9, Chills, Headache, Redness at injection area.  Extreme Soreness at and around injection area.  Fever off and on for 3 days.  Treatment with Tylenol									Y	10/12/2004	10/13/2004	1		UNK	UNK						1						1	Chills; Headache; Injection site erythema; Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~U1440AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~U1489AA~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0227897	10/18/2004	AL	43.0	43		F	05/23/2005	When I went to go to sleep, I laid down as usual, but I couldn't relax. My legs felt tingly. I only slept 1 hour the entire night. Legs kept feeling like there was vibration under the skin on both legs (beginning at the hips & moving down) all night. I would get up, walk around, but the instant I would try to relax it would begin. Also, I developed muscle twitching. I could actually visually see tiny muscles jumping at various places all over my legs. ALL NIGHT (still occurring 10/18/04 - & some on my body).  Next day, felt tired, slight stomach upset. Muscles felt weak. By 10/16 night I was exhausted and slept but felt the tingling as I fell asleep.  Felt slight tingling all day when at rest. 10/17/04 Sunday - felt the tingling when at rest. Now my upper body (arms) felt weak and began to experience a slight vibrating feeling and weakness. Some tingling and twitching continued as I went to sleep tonight.  Today 10/18/04 I still feel an odd sensation over my body and some muscle twitching. Other symptoms included deep leg pain & knee pain or stiffness that began Saturday afternoon - helped w/ Ibuprofen. Buzzing, tingling throughout body. Kept me awake several nights. Then it became sporadic buzzing, tingling, pinching and worst of all constant fasciculation and parethesia. Continued symptoms to present. Symptoms occur 24 hrs a day! Some days better, some worse than others. DR has recommend that I do not get an influenza vaccine next year.								Y	N	10/15/2004	10/15/2004	0	None taken yet - waiting to see if the symptoms improve. If not I will go to a neurologist within a couple of weeks. Hoping for a natural resolution without intervention. Will watch for life threatening signs that occur w/ Guillain-Barre'. Multiple blood test by Dr. also nerve/sensory condition & EMG. DR reports symptoms appear to be directly related to the influenza vaccine. Other then symptoms no underlying illness.	UNK	UNK	Ortho Novum 1-35/28 day. Ibuprofen began after the vaccine. No other the week before or day of or days after.	NONE	None. I was hit in the back by a chiropractor 2+ yr. ago and have had some back pain - releived with rest & heat pad, but tests show no problems. Otherwise - healthy - exercise 5-6 days per week at least 30-45 min. each time, perfect weight also. No use of tobacco either.	arm swelling/pain/dev. flu symptoms - age given is est.~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Arthralgia; Fatigue; Joint stiffness; Muscle contractions involuntary; Muscle twitching; Muscular weakness; Paraesthesia; Sleep disorder; Stomach discomfort	FLU3~SANOFI PASTEUR~41455EA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0227899	10/18/2004	CA	33.0	32		F	10/18/2004	I received the FluMist on Friday, October 15, 2004. On Saturday I noticed that I was becoming increasingly thirsty and my throat was very scratchy. By Saturday night I felt weak and very tired and my throat was very painful. All night Saturday and into Sunday my sx became worse with coughing and wheezing. All day Sunday and into Monday, I felt really awful with sweats and fatigue along with hoarseness, coughing and a sore throat.									U	10/15/2004	10/16/2004	1		UNK	UNK	Just Advil	None	Sarcoidosis			1						1	Asthenia; Cough; Dry throat; Dysphonia; Fatigue; Hyperhidrosis; Pharyngolaryngeal pain; Thirst; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500335P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0227901	10/18/2004	VA	47.0	46		F	10/18/2004	Employee rec'd vaccine 10/8 @ about 2PM.  Awoke Saturday AM achy & having diarrhea off and on.  Took Tylenol and felt some better. Soon after this she felt achy & weak, stated her legs felt funny.  Her legs & elbows felt shaky as if her blood sugar was low.  She then donned a gown & gloves for a procedure, and got very hot, and she sat down for a few minutes.  She stated she then had to lay down, so she laid across the desk, and called the outpatient facility for help. She proceded to have nausea & dry heaves, and said she couldn't hold her head up.  She tried to get up to go to the bathroom, but said she couldn't stand.  After using the bathroom, she said she couldn't pull her pants up. She then was taken to the ED where she felt numb from her knees down, and her elbows down.  At this point she states she was unable to move anything except her head.  After a liter of fluids, she felt some better, she was admitted to the ICU overnight as her MD felt she may have acute onset of Guillian Barre' Syndrome (ruled out).  The next day, she was able to move, and had sensation back, was moved to a med surg floor, and discharged Monday.  Her medical doctor stated he found nothing, and referred her to a Psychiatrist, who also cleared her.  Today when she called, she states she still feels weak, has frequent headaches, and neck pain.  Her right hand, and both feet feel numb at times.  Friday 10/15 she states she had a lot of rib pain, and it hurt to take a deep breath.  She states one of the neurologists state she may have contracted the flu from the flu shot, as her immunity may have been down from a stomach ache (?virus) earlier the week that she had the shot.  She denies any fever, sore throat, cough or cold symptoms, and felt woozy last night.  She related while experiencing the paralysis, that she was told that she was hyperreflexive. Upon today's conversation, states that she had a reaction years ago when the vaccine was still a live virus vaccine, has rec'd it since without any problem. Medical Record received on 2/02/2005 states appetite impaired, dizziness, conversion disorder, and anxiety. Follow up 01/18/05: The pahysicians decided (at the patient's last report) that they don't feel this reaction was due to the vaccine.				Y	Y	3			Y	10/08/2004	10/09/2004	1	Initial chemistries done in the ED were OK the patient said.  I do not have access to her patient chart.	UNK	UNK	Effexor, Synthroid, Prevacid, Estradiol, Lasix, Toprol XL	Had had a stomache ache the Tuesday prior to being vaccinated on Friday, but thought she was ok on Friday.	Allergic to Codeine History:  GERD, Depression, Hypothyroidism, Irregular Heart Bead	Felt like she had the flu~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Anorexia; Chest pain; Conversion disorder; Diarrhoea; Dizziness; Feeling hot; Headache; Hyperreflexia; Hypoaesthesia; Hypokinesia; Muscular weakness; Nausea; Neck pain; Pain; Retching; Tremor; Anxiety; Asthenia; Diarrhoea; Dizziness; Headache; Hyperventilation; Hypokinesia; Nausea; Neck pain; Pain; Retching	FLU3~SANOFI PASTEUR~U1377AA~7+~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1377AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0227903	10/18/2004	GA	48.0	48		F	10/18/2004	Received shot at 0730 and at 0900 area swollen, red, warm with pain to upper arm.  Red area approx 5 inches long.  Motrin taken.  1600 pain continues with swelling.  Motrin taken again.									U	10/18/2004	10/18/2004	0		UNK	UNK						1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1445AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227904	10/18/2004	CT	9.0	8		M	10/18/2004	VOMITING									Y	10/16/2004	10/18/2004	2	NONE	UNK	UNK	NONE	HEART CONDITION	HEART CONDITION			1						1	Vomiting	FLU3~SANOFI PASTEUR~U1439AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227905	10/18/2004	OH	71.0	71		M	10/18/2004	First symptom was an ache in the abdominal area which began 12 hours after infection of the flu vaccine.  The abdominal discomfort woke up the patient and he remained uncomfortable with this for a few hours and then it subsided.  Chills and Fever of 101.6 degrees farenheit began about 8 hours later or approximately 18 - 20  hours after receiving the flu injection.  Chills and fever remained for 3 days.  During this time the patient had almost no appetite but would drink orange juice.  The chills and fever disappeared at the beginning of day 4 and his appetite and some energy returned.  On day 5 (today) a low grade fever of 99.6 degrees is present and he feels very weak and cold again and he does not have an appetite.  If he is still the same tomorrow I'm taking him to our Internist for evaluation.   Unknown resolution at this time.									U	10/13/2004	10/14/2004	1	None so far.	UNK	UNK	Lopressor Coumadin Prednisone Lipitor Multiple Vitamin Vitamin E, 400 U Baby Aspirin	None	Myasthenia Gravis Coronary Artery Disease Atrial Fibrillation			1						1	Abdominal discomfort; Abdominal pain; Anorexia; Asthenia; Chills; Pyrexia	FLU3~SANOFI PASTEUR~U1426AA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227911	10/19/2004	IL	66.0			F	10/13/2004	Patient had uterine leiomyoscarcoma 1999 with pulmonary metastasis. Patient received her second cycle of her cheo-taxotere and gemzar in 9/28/04 and had a flu vaccine 9/30. 10/8 developed flu-like symptoms which include cough, fatigue, and myalgia, and questionable fever. 10/9 increased weakness that she was unable to walk around the home. 10/10 reported improvement and also reported taking Aleve, Advil, Tylenol, and Robitussin. 10/11 continued to have difficulties in walking without help but her cold symptoms resolved. Patient also noted minor transient blurred vision which resolved within 30 minutes and also anxiety. 10/12 admitted to ICU through ED on wheelchair when her Hgb was found to be 4.4. Discharge Summary received on 11/17/2004 states pt experienced anemia.  Medical Record received on 11/17/2004 states pt experienced dyspnea and hemolytic anemia.					Y			Y	U	09/30/2004	10/08/2004	8	Bil 2.3; Alk pho 233; SGOT 69; HDL 376; Hgb 4.4; Plt 511; Retic 5.7; Haptoglobin 223; +VE cold agglutinin, staphylococcus PCR pending.  Medical Record received on 11/17/2004 states reticulocytosis and liver studies abnormal.	UNK	UNK	Nexium 20mg PO qd; Docetaxel 170mg infusion; Gemcitabine 1500mg infusion.		Discharge Summary received on 11/17/2004 states pt had a history of malignant neoplasm.  Medical Record received on 11/17/2004 states pt had a history of esophageal reflux, intraabdominal masses, lung metastases, and leiomyosarcoma.			1						1	Anaemia; Anxiety; Asthenia; Cough; Difficulty in walking; Dyspnoea; Fatigue; Haemolytic anaemia; Influenza like illness; Laboratory test abnormal; Liver function test abnormal; Myalgia; Pharyngitis; Pyrexia; Rhinitis; Vision blurred; Abasia; Cough; Fatigue; Influenza like illness; Laboratory test abnormal; Myalgia; Pyrexia; Vision blurred	FLU3~SANOFI PASTEUR~U1418AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation,Disabling	Influenza
0227913	10/19/2004	CA	24.0	24		F	10/12/2004	Noticed redness around site (left deltoid). Measured 2.5cm.									Y	10/11/2004	10/12/2004	1		UNK	UNK						1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U1452AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227914	10/19/2004	AK	7.0	7		F	10/12/2004	Onset generalized petechial rash several hours after influenza vaccine. Area without other symptoms. Mild peripheral eosinophilia 10/9, decreasing 10/11. No reporting of joint symptoms. No seizures. Child does have multiple medication allergies.				Y					Y	10/07/2004	10/07/2004	0		PVT	PUB	Valproic acid (Carbamazepine)	NONE	Seizure disorder, Fetal alcohol spectrum disorder, mental retardation (MR)		AK200460	1						1	Eosinophilia; Petechiae	FLU3~SANOFI PASTEUR~U1377AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227915	10/19/2004	FL	10.0	10		F	10/13/2004	Within 2 hours left arm began to swell with excrutiating pain. Within 6 hours client was bedridden with fever, chills and vomiting that progresed to irregular heart rate and feeling light-headed by the next day. The left arm was then grossly edematous prompting client to go to the ER where she was diagnosed with Allergic Reaction.				Y					Y	10/09/2004			NONE	PUB	UNK	NONE	NONE	Allergic to Flagyl, Monistat, Sulfa Drugs, Acifex Glucosamine.			1						1	Chills; Dizziness; Heart rate irregular; Hypersensitivity; Oedema; Pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1463AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0490P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0227916	10/19/2004	WI	1.01	1	.0	F	10/18/2004	Local skin reaction, measuring 7.5x11cm red, firm, warm. Treated for cellulitis due to exam (Augmentin). Problem on left leg (Dtap/Comvax)									Y	10/11/2004	10/11/2004	0		PVT	PVT	Amoxicillin	Resolved/ Resolving otitis media	NONE			1						1	Cellulitis; Erythema; Feeling hot; Injection site induration	DTAP~SANOFI PASTEUR~C1700AA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1450AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0431N~3~IM~LL~HIB + HEP B (COMVAX)~1	USA		Influenza
0227917	10/19/2004	WA	5.0	5		M	10/16/2004	Swollen right arm with pain , redness around injection site.									U	10/14/2004	10/15/2004	1		PVT	PUB						1						1	Injection site erythema; Pain; Swelling	FLU3~SANOFI PASTEUR~U1436AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227919	10/19/2004	OK	43.0	43		F	09/12/2004	Within 1-2 hours of receiving vaccination by body got feverish: hot all over and I suffered an excruciating past infection. The shot was a large dose like a 4 on the syringe instead of a small one. I'm not sure what was really given to me, but I had a bad reaction. Reminds me of other bad injections. Don't know this was offered to anyone on medication.									Y	07/23/2004	07/23/2004	0	NONE	PVT	UNK	HCR, Flexeril, Tylenol, DepoEstradol	Sinus infection	Allergies			1						1	Discomfort; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~UE134AA~1~~~MENINGOCOCCAL (NO BRAND NAME)~1	USA		Influenza
0227920	10/19/2004	NY	58.0	57		F	10/14/2004	Fever 103, chills, headache x 7 days. Pain behind left eye, diarrhea, nausea. Didn't eat or drink x 3 days. Called MD every day. Seen MD on 10/4/04.				Y					Y	09/28/2004	09/28/2004	0	NONE	PVT	PVT	PPD Shot, Lipitor, Mobic	NONE	Allergy sulfa, elevated cholesterol			1						1	Anorexia; Chills; Diarrhoea; Eye pain; Headache; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~U1344AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227921	10/19/2004	GA	67.0	67		M	10/14/2004	10/12/2004: Received Pneumovax in right deltoid. Following AM: arm red and hot to touch. Redness totally covering upper arm.				Y					Y	10/12/2004	10/13/2004	1		PUB	PUB	BP Med, Antiinflammatory for back	NONE				1						1	Erythema; Feeling hot	FLU3~SANOFI PASTEUR~U1427AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0685N~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0227922	10/19/2004	WY	15.0	14		M	10/14/2004	Received flu vaccine at 4 pm 10/12/2004. At 1 AM 10/13/2004 awoke suddenly with violent shaking and shuddering. Complained of severe headache and weakness also freezing cold sensation. Taken to ER. Symptoms subsided mostly by time MD arrived. Treated with Tylenol and fluids. 0400 T102. Weakness, fatigue and aches persisted 10/13. Okay by 10/14/2004.				Y					Y	10/12/2004	10/13/2004	1	NONE	PUB	PVT	Advair 250/25, Zyrtec, Nasonex: started these 10/08/2004	none	History : hyporesponsive episode with pertussis; asthma	hyporesponsive episode~DTP (no brand name)~3~0.50~In Patient		1						1	Asthenia; Fatigue; Feeling cold; Headache; Pain; Sensory disturbance; Tremor	FLU3~SANOFI PASTEUR~U1496AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227923	10/19/2004	WY	74.0	74		F	10/13/2004	Left upper arm is hot, swollen to elbow, painful and red. Temp 99 degrees. Called doctor. Advised to apply ice and take Tylenol.									Y	10/12/2004	10/12/2004	0		PUB	PVT	Aleve	NONE				1						1	Erythema; Feeling hot; Pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~1418AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1138N~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0227924	10/19/2004	WY	62.0	61		M	10/06/2004	Pt vaccinated around 1:00pm. No adverse reaction in office. Wife reports around 1/2 hour after receiving vaccine he began experiencing throat closing up  + hoarseness. Also uneasy stomach. Reports he was very restless during night Mon/Tues. Didn't feel well yesterday. Still not well today though going about activities. Has not seen doctor. Encouraged strongly to do so. Pt called. Stated he's feeling much better. I don't think it's form the shot. States he's heard there's a lot of crud' going around and he thinks that is what he's had. States his initial symptoms was itching in throat then bad cold ' symptoms: cough, feeling of congestion. Nurse stated Doctor has not returned call. We will contact him again and ask that he call pt to help determine if he feels symptoms were from flu vaccine. states, I'll get another flu shot next year because I get them all the time. Informed we would want to know if any future shots are contraindicated.									U	10/04/2004	10/04/2004	0		PUB	PUB	Celebrex, Azmacort, Zectia, Vitamins, Natural HA	NONE	Asthma			1						1	Abdominal pain upper; Dysphonia; Influenza like illness; Restlessness; Throat tightness	FLU3~SANOFI PASTEUR~U1439AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227925	10/19/2004	GA	1.59	1	.6	M	10/13/2004	Chicken pox rash, clear blisters on hand , legs stomach after  vaccine.									U	10/06/2004	10/13/2004	7		PVT	PVT	NONE	NONE	NONE			1						1	Blister; Rash vesicular	DTAP~SANOFI PASTEUR~C1663AA~1~~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1379AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0432N~1~~LL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~1034N~1~~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A57556F~UNK~~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0186P~1~~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0227926	10/19/2004	GA	42.0	41		F	10/06/2004	Itching on upper back; history of adverse reactions that have begun in a similar fashion.									Y	10/06/2004	10/06/2004	0		UNK	UNK	Prevacid, Singulair, Qvar, Spiriva, Foradil, Efexor, Bextra, Cancoprodil, Albuterol	Asthma, Fibromyalgia, Back ailment, Anxiety, Depression	Environmental allergies			1						1	Pruritus	FLU3~SANOFI PASTEUR~U1448AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227927	10/19/2004	NY	23.0	22		F	10/14/2004	Redness at site, itchiness, rash on neck									Y	10/13/2004	10/13/2004	0		PVT	PVT	Orthoeura	NONE	NONE			1						1	Injection site erythema; Pruritus; Rash	FLU3~SANOFI PASTEUR~U1379AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227928	10/19/2004	NM	48.0	48		F	10/07/2004	Erythema and elevated skin temp at site of injection.									Y	10/04/2004	10/04/2004	0		PVT	UNK	Zyrtec, Singulair, Synthroid, Lovastatin, Lo-Estren	NONE	Asthma, Hyperlipidemia, Obesity			1						1	Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~0564n~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227929	10/19/2004	NC	48.0	47		M	10/12/2004	Pt experienced fever to 102 with chills within 12 hours of vaccine. Mild headache. Duration of symptoms 24 hours.									Y	10/08/2004	10/09/2004	1	CBC: WNL	PVT	PVT	Methotrexate, Fosamax, Folic Acid, Remicade, Calcium		Crohn's Disease, Allergies to MSDA, Imuran			1						1	Chills; Headache; Pyrexia	FLU3~SANOFI PASTEUR~U1419AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227954	10/19/2004	VA	0.0			M	10/19/2004	A patient received Small Pox on the 15th - we did not know he was ill at that time, he subsequently developed abscess under chin (or probably had before we left - unclear) - we I&D the abscess and admitted him and started IV antibiotics- Yesterday afternoon, developed white papular rash - spreading from bilateral axillary to chest, back, and bil arms, scant involvement of lower extremities- noted 1 or 2 white pustules yesterday and now we are called the papular rash - white pustules, + pruritus, temperature spike to 102.2, + body aches, hand swelling 1+, +erythema palmar surface, arms, and chest - somewhat resolved this am.   This rash developed after infusion of antibiotic - we are unclear at this time if this rash is a reaction to antibiotic, infectious process, or vaccines, or all of the above he received anthrax, flu and small pox all in one shot on the 15th.  Performed day three check on small pox site today, only noted small red 'pimple' and some erythema surrounding site.  He is stable and currently afebrile, WBC today 13.5 - 15.0 on the 17th - we switched antibiotics - started benadryl 50 mg q 6   We are now thinking this rash may be secondary to small pox  He had the abscess when we vaccinated him (we did not know this at the time), he return to medical early am on the 17th with c/o chin pain & fever ____________________  Let me recap what you said: You stated the patient was innoculated with Anthrax, Influenza and Smallpox on the 15th but was ill (no one knew this). Describe what you mean by ill? He then developed an abcess the next day, about Oct 16 with admission for I&D and antibiotics.  On Oct 17 he developed a rash as below, with fever and body aches, palmar erythema, and other symptoms below after receiving IV antibiotics.     Yes the rash sounds like Non-Viral pustulosis, which has been seen by the VHC.  Note information below. All three vaccinations stimulate an immune response creating fever, body aches, malaise, and others.     What antibiotic did you use?  Any history of a drug reaction in the past?					Y				Y	10/15/2004	10/16/2004	1	admitted to ships medical for I&D of chin abcess and IV antibiotics. WBC today 13.5 - 15.0 on the 17th - we switched antibiotics - started benadryl 50 mg q 6	OTH	MIL	unknown	chin abcess, pt did not advise of presence until @24 hours after vaccinated	none reported			1						1	Abscess; Erythema; Injection site vesicles; Oedema peripheral; Pain; Pyrexia; Rash papular; Rash pustular	ANTH~EMERGENT BIOSOLUTIONS~~1~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1	USA	Hospitalisation	Influenza
0227959	10/19/2004	CA	9.0	8		M	10/19/2004	Received IM injection of influenza vaccine at 0930 on October 19, 2004. About 45 minutes later, developed pain at injection site which spread to arms, legs and cheeks. No wheezing or respiratory difficulties. Had mild-moderate tenderness of large muscles (thighs, upper arms) as well as cheeks of face. Subsided about 30 minutes after returning to our clinic. Treated with ibuprofen; but symptoms seemed to subside before the ibuprofen would have take effect. All symptoms gone in 90 min.									Y	10/19/2004	10/19/2004	0		UNK	UNK	QVAR inhaler; Albuterol Inhaler	None	Asthma			1						1	Injection site pain; Myalgia	FLU3~SANOFI PASTEUR~U1449AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227968	10/19/2004	UT	3.0	2	.9	M	10/19/2004	Influenza shot given 10/12/2004 Patient on 10/14 had vomiting and on 10/15 had abdominal pain. 2 days later he had a fever and a itchy rash on the right side of his neck on 10/17/2004.									U	10/12/2004	10/14/2004	2	None	UNK	UNK						1						1	Abdominal pain; Pyrexia; Rash pruritic; Vomiting	FLU3~SANOFI PASTEUR~u1447aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227970	10/19/2004	TX	67.0	66		F	10/19/2004	Sore throat & ear, tickling throat, weakness, body felt heavy, sore all over, more difficult to breathe, slight chill, coughing.  I have had flu shots for past 3-4 years & NEVER had this reaction.  Took Benadryl & Robitussin.									N	10/13/2004	10/14/2004	1		UNK	UNK	Aleve	none	none			1						1	Asthenia; Chills; Cough; Dyspnoea; Pain; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U1440AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227971	10/20/2004		0.5			M	10/18/2004	This case was considered medically important (OMIC). Information regarding Prevnar was received from a healthcare professional regarding a 6 month old male patient who experienced possible anaphylactic reaction. The patient received a dose on 9/28/04. The patient also received a dose of Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine and a dose of Influenza Virus Vaccine Polyvalent on 9/28/04. The patient's concurrent illness includes food allergy to eggs. Indication for Prevnar was immunization. Product was administered on 9/28/04. Dose regimen was 1 dose. Concomitant medications were not reported. Two hours after receiving vaccines on 9/28/04, the patient developed hives and eyelid swelling. The physician felt that the child had experienced a possible anaphylactic reaction. The patient was treated with Benadryl and recovered.									Y	09/28/2004	09/28/2004	0	UNK	OTH	OTH	UNK	UNK	Food allergy		HQWYE715712OCT04	1						1	Anaphylactic reaction; Eyelid oedema; Urticaria	DTAP~UNKNOWN MANUFACTURER~~UNK~~~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PNC~PFIZER\WYETH~74398B~UNK~~~PNEUMO (PREVNAR)~1	USA		Influenza
0227983	10/20/2004	PA	2.0	2	.0	M	10/12/2004	Hives. No reaction at injection site. Loose stools, mild URI symptoms and hives occurred 10/7/2004.									Y	10/06/2004	10/07/2004	1	NONE	PVT	PVT	Xopenex prn	NONE	Intermittent Asthma			1						1	Diarrhoea; Upper respiratory tract infection; Urticaria	FLU3~SANOFI PASTEUR~U1389AB~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227984	10/20/2004	MI	56.0	56		F	10/13/2004	10/9/04: left arm (pneumonia vaccine injection arm) , itchy , red, hot, swollen. Benadryl 25mg taken. Redness heat, swelling and itching is not at injection site, but 2 inches away. Supervisor felt that VAERS form should be submitted.									Y	10/08/2004	10/09/2004	1	NONE	PUB	PVT		NONE	Asthma, HTN, Hypothyroid, History pneumonia			1						1	Erythema; Feeling hot; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U1425AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0664N~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0227985	10/20/2004	PA	65.0	65		F	10/13/2004	20 minutes after flu vaccine. She felt hot and flushed-face, neck trunk , legs mostly, arms L>R hard initially she felt tingling . No SOB. Afebrile. US stable , flushing subsided over >2 hours. PO Benadryl preivously had fluraccone with reaction.									U	10/13/2004	10/13/2004	0		UNK	PUB	MV1, Calcium	NONE	NONE			1						1	Feeling hot; Flushing; Injection site induration; Paraesthesia	FLU3~SANOFI PASTEUR~U1489AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227986	10/20/2004	NE	69.0	69		F	10/12/2004	1 single nodule right below my hair line on head or neck  about 1 inch and has been there for one year as I write this. Had taken flu shots for about 15 years , no adverse event.									N	10/09/2003	10/09/2003	0		UNK	UNK	Antihistamine	NONE	Allergies, but not to eggs			1						1	Skin nodule	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0227987	10/20/2004	MS	76.0	75		F	10/11/2004	Around injection site around 3 diameter, pt had redness, whelps, warm to touch, tender. Arm sore. As of 10/10/04, sx improved, arm still red in localized area. Pt self-treated with Benadryl. Redness gradually decreased in size. No whelps, Not sore.									Y	10/05/2004	10/06/2004	1	NONE	UNK	PVT	UNK	Recent eye surgery	UNK	30 Years ago very sick~Influenza (Seasonal) (no brand name)~1~45.00~In Patient		1						1	Feeling hot; Injection site erythema; Similar reaction on previous exposure to drug; Tenderness; Urticaria	FLU3~SANOFI PASTEUR~U1440AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227988	10/20/2004	MT	34.0	34		F	10/12/2004	Vaccine given 10/8/04 at 13:15. Approximately 18:45 hands became hot and itchy. Few hours later feet became hot and itchy. Woke up 10/9/04 and was blotchy all over. Went to MD and received Zyrtec for itching.									Y	10/08/2004	10/08/2004	0		UNK	PVT	Albuterol as needed		Asthma, Heart Murmur			1						1	Feeling hot; Pruritus; Rash macular	FLU3~SANOFI PASTEUR~U1462AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227989	10/20/2004	NY	1.39	1	.4	M	10/14/2004	Febrile seizure 10/9/04. URI symptoms began the day prior.				Y					Y	09/29/2004	10/09/2004	10	NONE	PVT	PVT	NONE	URI at time of seizure	Medical Record received on 1/3/2005 states viral illness and hives.			1						1	Febrile convulsion	DTAP~SANOFI PASTEUR~C1699AA~4~~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~1489AA~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1006~3~~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0227990	10/20/2004	CA	4.0	4		F	10/11/2004	According to mom the evening of 10-9-04, child developed hives on the site of injection and hives down legs. By Sunday AM, hives on trunk and face. Child also developed wheeze. Mom gave Benadryl and started nebulizer treatment. Mom called Monday 10/11/04. Child better.									Y	10/09/2004	10/09/2004	0	NONE	PVT	PVT	NONE	NONE	Omnicef: skin rashes. History of asthma.			1						1	Injection site reaction; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U1381AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227991	10/20/2004	CA	8.0	8		M	10/13/2004	Generalized urticaria reaction and swelling of legs and feet; treated with Prednisone 50mg/day; reaction faded within 24 hours. Medical record states allergic reaction. msv				Y					Y	10/11/2004	10/11/2004	0	NONE	PVT	PVT	Albuterol, Flovent	Mild asthma, persistent	Asthma Medical records states Hx of allergic reaction. msv			1						1	Hypersensitivity; Swelling; Urticaria	FLU3~SANOFI PASTEUR~W1489AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0227992	10/20/2004	NJ	89.0	88		M	10/15/2004	10/6/04 one day after general weakness: had to stay in bed for 2 days (tired) then 2 more days general of tiredness.									Y	10/05/2004	10/06/2004	1	NONE	UNK	UNK		NONE	Osteoporosis			1						1	Asthenia; Fatigue	FLU3~SANOFI PASTEUR~U1426AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227993	10/20/2004	NJ	72.0	72		F	10/15/2004	10/6/04: general weakness for three days. 10-6-04: suddenlylost hearing in the evening. Audiologist diagnosed nerve damage. Put on prednisone.									Y	10/05/2004	10/06/2004	1	NONE	UNK	UNK		NONE	Osteoporosis			1						1	Asthenia; Hearing impaired; Nerve injury	FLU3~SANOFI PASTEUR~U1426AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227994	10/20/2004	TX	59.0	58		F	10/11/2004	Tongue Paresthesia: 5 min later and dizziness half hour later. All sxs resolved in 3-4 hours.									Y	10/06/2004	10/06/2004	0	NONE	PVT	PVT	NCB RX: Asthma	none	asthma			1						1	Dizziness; Tongue paralysis	FLU3~SANOFI PASTEUR~U1410BA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228028	10/20/2004	MO	0.51	0	.5	F	10/20/2004	FEVER OF 103.2 FOUR AND ONE HALF HOURS AFTER INJECTION.  FEVER UP TO 106 BY NEXT AM.				Y					Y	10/18/2004	10/18/2004	0		UNK	UNK	PREVACID 15 MG. 1/2 PACKET TID TYLENOL	MOM STATES CHILD FELT SLIGHTLY WARM PRIOR TO APPT.  TEMP AT APPT TIME 97.1	GERD (REFLUX)			1						1	Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~21AA07AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1458AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE427AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~495941~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0228043	10/21/2004	MD	49.0	49		F	10/15/2004	Customer rec'd flu shot at her work site. No Hx of allergies or allergic to eggs/ takes flu shot annually. 15-20 min after taking shot reports racing heart and SOB. 911 called/ Epinephrine 0.3 SQ by RN. EMT/Hospital. Per Pt Immediately felt weird became SOB within 5 min returned to clinic site, treated with Epi, transported to hospital, feels much better by then; observed home with advice for prn, Benadryl use her inhaler, return prn (no vax for several yrs). Medical records state tight chest. msv				Y					Y	10/08/2004	10/08/2004	0	ER Eval, pt released/returned to work.	OTH	PVT	Albuterol	NONE	Asthmatic, Hx of allergy to preservatives			1						1	Chest pain; Dyspnoea; Heart rate increased	FLU3~SANOFI PASTEUR~U1446AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228044	10/21/2004	MI	43.0	42		F	10/13/2004	Vomited 5 min after vaccine and began to have burning in throat. Pt is employee and did not report symptoms until 1 hour later. Then she also had audible sneezing. 17:35 exam room, unable to obtain B/P, tachycardia, experienced wheezing throughout lungs. Benadryl 50mgml PO at 17:40. Ambulance called. Pt vomited. Albuterol given. O2 given. Epinephrine at 1:1000, 0.3ml IM at 18:00 and Benadryl 50mg ml IM. Vomited again. Breathing worsened, unresponsive x 30 seconds, mouth to mouth given. Ambulance arrived. IV started. Transferred to ER. Admitted to ICU. Pt had 2 more episodes of unresponsiveness, during hospitalization.  Nurse follow up on 10/30/04 states: anaphylactic shock; Flushed; Ventricular tach; Arrhythmia; seizure; vagal reaction; tingling; stridor; pallor; urinary retention; insomnia			Y	Y	Y	4			Y	10/08/2004	10/08/2004	0	lab test abnormal;	PVT	PVT	Zoloft; Topamax; Epi Pen; Albuterol inhaler	NONE	Asthma; Anaphylactic reaction (bee stings, almonds, IVP dye).  MIGRAINE; hyperlipidemia; GI upset; constipation;			1						1	Anaphylactic shock; Apnoea; Arrhythmia; Coma; Convulsion; Dyspnoea; Hypoxia; Insomnia; Laboratory test abnormal; Pallor; Paraesthesia; Pharyngolaryngeal pain; Sneezing; Stridor; Syncope vasovagal; Tachycardia; Urinary retention; Vasodilation procedure; Ventricular arrhythmia; Vomiting; Wheezing	FLU3~SANOFI PASTEUR~U1489AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0228045	10/21/2004	WI	1.05	1	.0	F	10/14/2004	Within 24 hours of vaccination, patient developed vomiting and fever. Hospitalized for dehydration, fever, and right otitis media.  Nurse follow up on 11/01/04 states: gastroenteritis					Y				Y	10/11/2004	10/12/2004	1	CXR WNL; BAE WNL; lab values abnormal	PVT	PVT	NONE	NONE	Meningitis; Prematurity; Allergy;			1						1	Dehydration; Gastroenteritis; Laboratory test abnormal; Otitis media; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1380AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0366N~3~IM~RL~HIB + HEP B (COMVAX)~1|VARCEL~MERCK & CO. INC.~0100P~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0228049	10/21/2004	PA	5.0	4		F	10/13/2004	Tachycardia, Diaphoresis, Decreased oxygen saturation. Treated consistently with 0.2cc Epinephrine 1:1000 SC.									Y	10/13/2004	10/13/2004	0	NONE	PVT	UNK		NONE	Previous Rabies sequelae			1						1	Blood gases abnormal; Hyperhidrosis; Tachycardia	FLU3~SANOFI PASTEUR~U1383AA~3~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228050	10/21/2004	OH	68.0	68		F	10/16/2004	Pt received flu vaccine on Oct 8, 2004. She said she received shot high in left shoulder and felt needle hit the bone and nerve. By early AM  , oct 10th, she went to hospital ER because pain in her entire arm was so severe and couldn't tolerate it anymore. Physician gave anti-inflammatory drug, abx, and pain killers She mentions seeing her orhtopedic surgeon on OCT20th.				Y					U	10/08/2004	10/08/2004	0	NONE	UNK	UNK						1						1	Pain	FLU3~SANOFI PASTEUR~U1448AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228051	10/21/2004	SC	67.0	67		F	08/15/2004	Left arm first swelled at injection site. Was very sore then moved and swelled in forearm down to elbow. I hurt all over especially my neck. Doctors nurse told me to put ice on it and take Benadryl. By second night had fever and chills. The morning of 10/7/04, my arm was red and swollen . Had Dr give me cephalexin 500 mg x 7 days. Problem with left arm.				Y					Y	10/05/2004	10/05/2004	0		PUB	UNK		NONE	Hypothyroid			1						1	Chills; Erythema; Injection site swelling; Neck pain; Pain; Pyrexia; Swelling	DT~MASS. PUB HLTH BIOL LAB~TD117~UNK~~LA~DT ADSORBED (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0635N~2~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0228052	10/21/2004	TX	4.0	3		F	10/14/2004	Itchy, red, flat red rash, runny nose second day after flu vaccine. Questionable if Viral exanthum.									Y	10/11/2004	10/13/2004	2		PVT	PVT			RAD			1						1	Erythema; Pruritus; Rash; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1447AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228053	10/21/2004	TX	1.7	1	.7	M	10/12/2004	20 month old male with fever of 103F and vomiting.				Y					Y	10/11/2004	10/11/2004	0		PVT	UNK						1						1	Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~61476A19~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228054	10/21/2004	TX	81.0	80		F	10/12/2004	About 30 minutes after receiving Pneumococcal vaccine complained of itching, redness at site and a raised area the size of a softball noted. Swelling progressed to elbow and lower area. Complained of muscle aches, Headaches, and joint ache. Was seen in ER and advised hot, wet compresses and Motrin. So much better today and swelling is nearly gone.				Y					Y	10/09/2004	10/09/2004	0	NONE	UNK	PUB	NONE	NONE	NONE			1						1	Arthralgia; Headache; Injection site erythema; Injection site swelling; Myalgia; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U1439AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0257~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0228055	10/21/2004	TX	65.0	65		F	10/19/2004	Since 1978 had had flu vaccine with no reactions. Pt complains of soreness, swelling, chills, weakness, body aches a bit of nausea and dizziness. It worsened towards the right so took Motrin and Vicoden. Went to bed, felt humble at night. Next day, still felt bad, malaise lessened by 6pm. Third day felt tired. No head cold sin 15 years or flu since 1978. the first day, there was no runny nose or sore throat.									Y	10/14/2004	10/14/2004	0		UNK	UNK	Prednisone		Arthritis, fibromyalgia (both for 10 years)			1						1	Asthenia; Chills; Dizziness; Fatigue; Malaise; Nausea; Pain; Swelling; Tenderness	FLU3~SANOFI PASTEUR~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228056	10/21/2004	CA				M	10/18/2004	Swollen leg after immunization.  Follow up on 10/28/04 states: Right leg has site problem.									Y					PVT	PVT		NONE	NONE			1						1	Swelling	FLU3~SANOFI PASTEUR~U1476AA~2~SC~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A57559C~4~SC~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0286P~2~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0228077	10/21/2004	LA	35.0	34		M	10/21/2004	Began with slurred speech, tingling to leg and weakness on 10/16/04.  Not progressing at present time. Medical records state dizzy, viral syndrome. msv				Y					N	10/08/2004	10/16/2004	8	CT of head, CBC, flu swab, Mono spot	UNK	UNK	Unknown	None	History of Wolfe-Parkinson-White (WPW) Medical records state hypertension, msv			1						1	Asthenia; Dizziness; Dysarthria; Paraesthesia; Viral infection	FLU3~SANOFI PASTEUR~U1458AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228078	10/21/2004	VA	59.0	58		F	10/21/2004	Morning following vaccination, severe diarrhea - musche aches, chills, dizzy, light headedness X 1 day.  Weakness, generalized 2 days.									Y	10/08/2004	10/09/2004	1	None	UNK	UNK		Several co workers had had gastrointestinal symptoms earlier in the week.  This employee has not called me so that I can see if she was one of them.  I have only written information.				1						1	Asthenia; Chills; Diarrhoea; Dizziness; Myalgia	FLU3~SANOFI PASTEUR~U1377AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228079	10/21/2004	IN	79.0	78		M	10/21/2004	Hives over trunk and extremities.									Y	10/14/2004	10/15/2004	1	none	UNK	UNK	Prednisone, Aleve, Plaquenil, Flomax, Glucosamine, B6		Arthritis, Asthma-like lung disease. CA of prostate			1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0228081	10/21/2004	NC	1.26	1	.3	M	10/21/2004	15 month male previously healthy fell off a chair and was noted not to use right arm or leg after that.  He suffered from a left hemorrhagic stroke.  He has not an angiogram yet to determine if there is a vascular anomly.  Pt still in hospital. Discharge summary states loss of speech, weakness one side, lethergy. msv Medical record states loss of speech. msv				Y	Y				U	10/11/2004	10/12/2004	1	Brain MRI- Left hemorrhagic stroke, angiogram pending.	UNK	UNK						1						1	Aphasia; Cerebrovascular accident; Hemiparesis; Hypertension; Injury; Lethargy	DTAP~SANOFI PASTEUR~U1307BA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1417AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0809N~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A74404H~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0228082	10/21/2004	WI	79.0	78		F	10/21/2004	I received the vaccine at 2:00 Tuesday Oct 12th. That evening I felt so weak and my heart seemed to be beating hard.  When I tried to get up at about 5AM the next morning I was so dizzy, I actually fell back into the bed.  I was not able to walk for about one hour.  After about 5 hours I was over it, but still quite worn out and extremely weak.   I knew right away it had to be a reaction to the flu shot.  I called the Health Dept on Thurs of that week but they were giving out shots and did not have anyone to man the phones, I was suppose to leave a message.  I did not.									Y	10/12/2004	10/12/2004	0		UNK	UNK		none	none			1						1	Abasia; Asthenia; Dizziness; Palpitations	FLU3~SANOFI PASTEUR~U1488AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228083	10/21/2004	WI	72.0	72		F	10/21/2004	I received the vaccine at 12:45PM on 10-13-2004 At 10:40 PM the same day I  became extremely dizzy and weak, with rapid heart beat.  I suspected it was a reaction to the flu shot, and after talking to another person with the same symptoms, I am sure that it was.  I am reporting this to you for your records.									Y	10/13/2004	10/13/2004	0		UNK	UNK		none	none			1						1	Asthenia; Dizziness; Heart rate increased	FLU3~SANOFI PASTEUR~U1440AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228084	10/21/2004	NJ	9.0	8		M	10/21/2004	Received flu shot 7pm 10/20, developed difficulty breathing at school after lunch (also peanut allergic, but no known exposure) and was found by school nurse to be be wheezing, pale, diaphoretic, tachycardic and to have a fine urticarial rash. Patient improved with 2 puffs of albuterol, an inhalation treatment with albuterol and pulmocort, and 25mg. of Benadryl.  He was essentially well when evaluated in office within the hour and was continued on medications.				Y					Y	10/20/2004	10/21/2004	1		UNK	UNK		none	hx bronchitis, pneumonia < age 2 hx of asthma at least age 2 on Amoxil allergy 11/98 Peanut allergy 7/99			1						1	Dyspnoea; Hyperhidrosis; Pallor; Tachycardia; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U1452AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228085	10/21/2004	WI	9.0	8		M	10/21/2004	Very lethargic, fever with hallucinations.  Crying.   Very achy & weak. Headache.									Y	10/19/2004	10/20/2004	1		UNK	UNK	Albuteral, rhinocort, singular, zyrtec, advair	none	Allergic to oats.  Born with VATERS syndrome.  Asthma, G-tube-TEF repair, EA,			1						1	Asthenia; Crying; Hallucination; Headache; Lethargy; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0228086	10/21/2004	CA	1.85	1	.8	F	10/21/2004	After 24 hours the baby developed hives and they continued breaking out for another 24 hours plus. She was not exposed to any new foods during the period.  She is not allergic to eggs.									U	10/19/2004	10/20/2004	1		UNK	UNK						1						1	Urticaria	FLU3~SANOFI PASTEUR~U1463AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0211976	10/22/2004	NC	4.0	4		F	10/15/2004	Localized swelling, erythema, itching, cool compresses, Benadryl									Y	10/14/2004	10/14/2004	0		PVT	PUB	Tanaged		Allergic rhinitis		NC04111	1						2	Erythema; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U1417AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0228094	10/22/2004	MA	1.51	1	.5	M	10/18/2004	Had IPV, flu and PCV 7, 4 days prior to being S/B MD, developed rash on 10/14 on feet and hives on face as well as small bumps on chin. Hives noted by doctor on primarily face and neck, trunk rash sporadic, several hives on right arm were noted. Treated with Benadryl 3/4-1 tsp every six hours prn. Call if any respiratory sxs or edema. Do not give second flu.				Y					Y	10/11/2004	10/14/2004	3		PVT	PVT	NONE	NONE	NONE			1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~U1439AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X0771~3~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~495719~4~IM~LA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0228095	10/22/2004	WA	43.0			F	10/15/2004	One hour after injection, had a headache for 32 hours.									Y				NONE	PVT	PVT		NONE	NONE			1						1	Headache	FLU3~SANOFI PASTEUR~U1451AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228096	10/22/2004	WA				F	10/15/2004	Headache x 32 hours.									Y	10/11/2004	10/11/2004	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Headache	FLU3~SANOFI PASTEUR~U1451AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228097	10/22/2004	CA	71.0	71		F	10/16/2004	Paleness, dizziness, fainting, ache, pains, chills, fever, aching arm where shot administered, weakness 4 days bed rest.				Y					Y	10/11/2004	10/11/2004	0		PVT	UNK	Premarin, Asefester, Libroxthyrodar, Mechitest	NONE	IBS, hemmoroids, palpitations, thyroids.			1						1	Asthenia; Chills; Dizziness; Pain; Pallor; Pyrexia; Syncope	FLU3~SANOFI PASTEUR~U1489AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228098	10/22/2004	TX	74.0	74		F	10/18/2004	Left arm because reddened and swollen to wrist. Right arm became very swollen and red at injection site. ER doctor severe local reaction bilaterally: post mastectomy left arm. Antibiotics given. Pt forgot to tell nursing student about matectomy let side.				Y					Y	10/09/2004	10/09/2004	0	NONE	PUB	PUB	NONE	NONE	Left mastectomy			1						1	Erythema; Injection site erythema; Injection site swelling; Swelling	FLU3~SANOFI PASTEUR~U1439AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~AVENTIS PASTEUR~U1282AA~1~IM~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0228099	10/22/2004	IL	77.0	76		F	10/20/2004	Telephone call form doctor, client's PCP, who states client presented to his office with shingles presentation with patches from her upper arm to her hand.  It is only on right arm. Client complained of burning and itching on arm. Client denies fever or chills. PCP states will treat sxs. Spoke later with client who states arm still hurts but seems to be doing better. States PCP gave her oral medicine for hives to help relieve symptoms and to return to office on Monday.				Y					Y	10/15/2004	10/17/2004	2		PUB	UNK	NONE	NONE	NONE			1						1	Pruritus; Skin burning sensation; Urticaria	FLU3~SANOFI PASTEUR~U1503AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228100	10/22/2004	NC	92.0	92		F	10/13/2004	Developed fever, aches and nausea around 7 hours after receiving injection. Also had chills and lethargy. Symptoms lasted 36 hours. Highest temperature taken 101 degrees.									Y	10/11/2004	10/11/2004	0		PUB	PVT	Lipitor, Norvas, Adopurinol	NONE	Heart problems and high blood pressure		NC04109	1						1	Chills; Lethargy; Nausea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1411AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228161	10/22/2004	WI	34.0	33		F	10/22/2004	Patient complained of swelling of lymph glands beneath left arm.  By one week later, swelling in lymph glands beneath right arm.  Saw MD 10/19/2004 and diagnosis made of sinus infection.  Was given Zithromax to take x 3 days by 10/21/2004.  Pain lessened but not gone.				Y					Y	10/05/2004	10/10/2004	5	Blood test, included white blood count	UNK	UNK	Advair Albuteral	No	Asthma			1						1	Bacterial infection; Lymphadenopathy; Pain	FLU3~SANOFI PASTEUR~U1410BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228162	10/22/2004	FL	60.0	59		F	10/22/2004	RECEIVED SHOT ON 10/11.  THAT AFTERNOON FUNNY TASTE IN MOUTH.  PROGRESSED FOR DAYS TO ERRATIC BLINKING ON 10/15. 10/16 RIGHT EYE WON'T WINK OR BLINK, MOUTH IS OUT OF CONTROL ON RIGHT SIDE.  10/17 EMERGENCY ROOM DIAGNONSIS OF BELL'S PALSEY, PRESCRIBE 800 MG ACYCLOVIR, 5 TIMES DAILY FOR 7 DAYS.  10/17 DETAILED CONVERSATION WITH ENT DOCTOR. PRESCRIBED 180MG PREDNIZONE DAILY FOR 7 DAYS. 10/18 APPOINTMENT WITH ENT.  EXAMINE AND DIAGNOSIS OF BELL'S PALSEY(NEUROLOGICAL DISORDER) BROUGHT ON BY FLU VACCINE.  10/20 APPOINTMENT WITH OPTHOMOLIGIST FOR DRY EYE. Medical Records received on 2/8/2005 states hoarse.				Y					U	10/11/2004	10/11/2004	0		UNK	UNK	ACHIPHEX 20MG TWICE DAILY, COMBIPATCH ONE WEEKLY, PEPCID AC	NONE	REFLUX. Medical Records received on 2/7/2005 states allergy.			1						1	Dysgeusia; Dysphonia; Eye disorder; Facial palsy	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0228164	10/22/2004	IL	90.0	89		F	10/22/2004	Right arm (pneumovax site) caused reaction locally. Left arm (flu shot) unremarkable. Patient went to ER with pain & sweeling & fever to 101.5, ER MD started her in antibiotics & narcotics. Family reported decreased urine output and persistant pain & swelling.				Y					N	10/20/2004	10/21/2004	1	CBC & chem 7 collected	UNK	UNK	lisinopril evista zaroxolyn klorcon advair coumadin nexium singulair timoptic vexol ditropan actonel albuterol lanoxin	none	OA OP a-fib CHF COPD GERD incontinence			1						1	Dysuria; Injection site oedema; Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~u1462aa~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0926N~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0228166	10/22/2004	TX	56.0	56		F	10/22/2004	Received flu vaccine; within 20-30 minutes developed shortness of breath and resp wheezing. Self treated with Benadryl and daughter's inhaler, then saw private physician on 10-18-04, where she was given steroids and inhaler.				Y					Y	10/13/2004	10/13/2004	0		UNK	UNK	Vitamins, KCL, ASA	None	PCN allergy			1						1	Dyspnoea; Wheezing	FLU3~SANOFI PASTEUR~u1460AA~7+~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228168	10/22/2004	SC	80.0	80		M	10/22/2004	Client's wife called health department and reported that client received his flu shot on Tuesday, October 5, 2004 and was feeling fine.  On Thursday, October 7th, client told his wife he didn't feel well, was having body aches.  Wife reported client continued to feel worse and that by Saturday he reported he hurt all over and wanted to stay in bed.  Sunday AM, October 10th, client ate a bowl of cereal then returned to bed where he watched a ball game.  After the game his wife went to read the paper and came back into the client's room about 5:15 PM to see what he wanted for supper.  He told his wife he still didn't feel good, was feeling cold and shivering, but would eat a little of whatever she was having.  A little later the wife sent their adult daughter to the client's room to get him for supper and found him dead, still sitting up in bed. Due to client's work in a local funeral home he had requested no autopsy be done so client was taken directly to the funeral home and buried on Wednesday, October 13th.  According to his wife he had suffered several previous strokes and was a diabetic.  The wife also reported that a friend who is also a physician stated it sounded like the client had a heart attack.  The client has received flu vaccinations through the health department since 1998 with no adverse events.  Nurse follow up on 11/01/04 states: cardiovascular arrest; cerebrovascular ischemic disease; hypertension. -- 10/29/04 Copy of Death Certificate is received and lists COD as: cardiovascular arrest; cerebrovascular ischemic disease and hypertension.	Y	10/10/2004							N	10/05/2004	10/07/2004	2		UNK	UNK	NONE	NONE	Diabetes; previous strokes; cerebellar atrophy and bilateral prostatic hypertrophy - BPH.		SC0439	1						1	Cardiac arrest; Cerebral ischaemia; Chills; Hypertension; Pain	FLU3~SANOFI PASTEUR~U1394CA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0228171	10/22/2004	CA	0.9	0	.9	M	10/22/2004	Received vaccine 10/21/04.  Sleepy, tired by early evening. Temp 96.1 rectally.									Y	10/21/2004	10/21/2004	0		UNK	UNK	none	mild URI symptoms	none			1						1	Fatigue	FLU3~SANOFI PASTEUR~u14g3aa~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228173	10/23/2004	MO	40.0	40		M	10/23/2004	sore Throat, dry cough,sneezing, aches,fever, running nose									U	10/22/2004	10/22/2004	0		UNK	UNK						1						1	Cough; Pain; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea; Sneezing	FLU3~SANOFI PASTEUR~U1455EA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228175	10/24/2004	CT	1.59	1	.6	F	10/24/2004	DTaP and Flu vaccinations administed on 10/21.  Fever of 102-102 through the night, 9:00 a.m. 10/22 Stopped Breathing, turned blue, eyes rolled back, seisure.  Recesitation given within first minute.  Baby stopped breathing again for 2 minutes, revived by emergency staff, pale, unresponsive, seisures continued.  Pt 19 months old revived by Emergency Response Team.   Observed by Hospital Emergency Staff and later that night brought to Hospital where again observed for high fever. It is now the third day after the shot recieved, 10/24 baby is very pale, diarear, I am so scared additional seasures will occur and cause brain damage, I am in search of Doctors to watch her for the next 30 days.  Pt held her head today and said boo boo.  Please help us. Medical Records received on 1/3/2005 states pt experienced otitis media and was irritable.				Y					U	10/21/2004			Not performed	UNK	UNK	None	None	None	Seisure, Stop Breathing~DTaP (no brand name)~3~1.30~Patient		1						1	Coma; Convulsion; Eye movement disorder; Irritability; Otitis media; Pallor; Pyrexia; Respiratory arrest	DTAP~UNKNOWN MANUFACTURER~0~3~IM~LL~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~0~1~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0228176	10/24/2004	CA	67.0	66		M	10/24/2004	Experienced severe chills for several hours; not mitigated by 1/2-hr hot bath followed by bed with electrie blanket & heating pad.  stopped shaking about 1 AM. Next morning still felt extremely week & lethargic; continued until about 6pm on day followng shot (approx 24 hr duration)									Y	10/21/2004	10/21/2004	0	none	UNK	UNK		none	Diabeties (take insulin), Heart attack (1999), take warfarin for blood clots			1						1	Asthenia; Chills; Lethargy	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0228121	10/25/2004	GA	1.56	1	.6	M	11/04/2004	From initial information received on 15OCT2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that an 18 month old male patient received a second dose of Fluzone SV2004-2005 administered in the left thigh on 6OCT2004. 24 hours later, the patient developed a fever of 103 degrees F, which persisted for 24 hours. The patient experienced a febrile seizure at 11:00PM on 7OCT2004. The parents contacted emergency medical services , but refused to go to the ER. The patient was seen by a physician on 8OCT2004 for evaluation. He recovered form these events. From additional information received on 01Nov04 from a RN, the pt's full name, address and telephone number were provided. Pt's birth weight was reported as six pounds and seven ounces. The pt was reported to have two siblings. The vaccine administrator's name was also provided. On 20Sep04, the pt received his fourth dose of Daptacel, administered IM in the right upper thigh, his third dose of IPOL, administered IM in the right thigh, a dose of MEASLES, MUMPS and RUBELLA vaccine, manufacturer administered SC in the left thigh and a dose of Prevnar, manufacturer Lederle, administered IM in the left lower thigh. Reportedly, the nurse reviewed the information on 26Oct04.				Y					Y	10/06/2004	10/07/2004	1		PVT	UNK			The patient has a history of transient thrombocytopenia, which occurred as a neonate. He also has a sibling with a history of febrile seizures. He did not have any illnesses at the time of vaccination.		200403381	1						1	Febrile convulsion; Pyrexia	FLU3~SANOFI PASTEUR~U1418AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228125	10/25/2004	VT	64.0	64		F	10/20/2004	Very large area of redness, swelling, warmth and induration 15x15cm distal to right deltoid injection site of pneumococcal vaccine. Developed several hours after shot. As of next day, swelling somewhat diminished.									U	10/14/2004	10/19/2004	5	NONE	PVT	PVT	NONE	NONE	Right breast cancer; lymphactomy axillary dissectum, non ischemic cardiomyopathy.			1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U1421AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0740N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0228126	10/25/2004		9.0	8		F	10/16/2004	After 15 hours, left forearm at sight of immunization was tender, red, warm size 2x2 inches round area. Received Tylenol x1 dose in the evening. Symptoms resolved the next day.									Y	10/08/2004	10/09/2004	1	NONE	OTH	OTH	UNK	NONE	Allergy to cephalosporins and PCN;			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~A028BB~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0228127	10/25/2004	WI	5.0	4		M	10/21/2004	Right arm area red, swollen.									U	10/18/2004	10/20/2004	2	UNK	PVT	OTH	NONE	NONE	NONE			1						1	Injection site erythema; Injection site oedema	DTAP~GLAXOSMITHKLINE BIOLOGICALS~639A2~5~IM~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1450A~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W1619~UNK~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0316P~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0228128	10/25/2004	NJ	57.0	57		F	10/16/2004	Same day- 4 hours later had breathing difficulty, hives, swelling on hand, severe pain in lower abdomen. My brain felt very strange out of sorts. 1 week later on 10/16, I had to go to ER because I had difficulty breathing all week.				Y					U	10/09/2004	10/09/2004	0	1 week later on 10/16, I had to go to ER because I had difficulty breathing all week.	PUB	OTH	UNK	NONE	Asthma;			1						1	Dyspnoea; Feeling abnormal; Oedema peripheral; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0228129	10/25/2004	VA	13.0	12		M	10/13/2004	10/13/04: Red, hot and swollen area around site 1.5x2 inches. 10/14/04: redness has disappeared on arm now.									Y	10/12/2004	10/13/2004	1	NONE	PUB	OTH	Singulair; Rytapn;	NONE	Asthma; Allergies to PCN, cats, chocolate, peppermint, peanuts;			1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~1458AA~7+~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228130	10/25/2004	MI	51.0	51		F	10/15/2004	Fever, extreme generalized pain and stiffness. Starting 4 hours after flu shot, lasting 1-5 days. Stated couldn't move due to pain.									Y	10/13/2004	10/13/2004	0	NONE	PUB	PVT	Lipitor; Requip; Paxil; Bextra; Triazolone;	Fibromyalgia, Diabetes Mellitus;	Fibromyalgia, Diabetes Mellitus;		MI2004059	1						1	Musculoskeletal stiffness; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1462AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228131	10/25/2004	NC	1.26	1	.3	F	10/15/2004	She had fever to 102.8, myalgia (especially in the legs), runny nose, loss of appetite.				Y					Y	10/12/2004	10/13/2004	1	NONE	PVT	PUB	Motrin/Zyrtec;	Cold/URI;	NONE			1						1	Anorexia; Myalgia; Pyrexia; Rhinorrhoea	DTAP~SANOFI PASTEUR~U1300CA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1417AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE175AA~4~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A7440H~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0228132	10/25/2004	OH	41.0	40		F	10/18/2004	Redness, warmth, swelling around injection site 48 hours after given.				Y					Y	10/12/2004	10/14/2004	2	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U1383AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228133	10/25/2004	OH	47.0	46		F	10/18/2004	My arm got red & itchy and was warm to the touch with the redness spreading down my arm ER nurse spoke with my family physician who ordered Keflex.									Y	10/14/2004	10/15/2004	1	NONE	PVT	OTH	UNK	NONE	NONE			1						1	Injection site erythema; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U1383AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228134	10/25/2004	DC	52.0	52		F	10/19/2004	Severe headache started about 20 minutes after injection. Advil 2 tabs per mouth taken about 60 minutes after injection. Additional Ibuprofen 400mg given at 16:00.				Y					U	10/19/2004	10/19/2004	0	NONE	PVT	PVT	Synthroid 110mcg every day; Pravachol 20mg every day;	NONE	Hypothyroidism; Hypercholesterolemia;			1						1	Headache	FLU3~SANOFI PASTEUR~1439AA~6~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228135	10/25/2004	CA	39.0	39		F	10/07/2004	3.5 hours after being given shot, I became dizzy, hot, and began shaking. As time progressed I became nauseous, began to ache, and developed a sore throat. I had a very sore arm also.									Y	10/06/2004	10/06/2004	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Dizziness; Hot flush; Nausea; Pain; Pharyngolaryngeal pain; Tremor	FLU3~SANOFI PASTEUR~~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228136	10/25/2004	VA	6.0	5		M	10/19/2004	Urticaria after 1.5 hours of injection. Benadryl given with significant decrease of urticaria.									Y	10/18/2004	10/18/2004	0	NONE	PVT	PVT	Geodon; Claritin;	NONE	Asthma;			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1452AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228137	10/25/2004	MI	28.0	27		F	10/15/2004	Approximately 4 hours after flu shot-extreme fatigue, headache, pain in affected arm and shoulder; temperature 103.0F. Wednesday PM will Friday AM, nausea.									Y	10/13/2004	10/13/2004	0	NONE	PUB	PVT	NONE	NONE	NONE		MI2004058	1						1	Fatigue; Headache; Nausea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1462AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228138	10/25/2004	VA	0.62	0	.6	F	10/17/2004	Erythematous papulo-macular rash on face, arms, body, legs and eye swelling. Given 0.1cc (1:1000) epi SC. Benadryl 10mg per mouth. Home with Benadryl every 4-6 hours, prednisolone 18mg every day for 3 days.  Nurse follow up on 11/01/04 states: Irritable, allergic reaction.				Y					Y	10/16/2004	10/16/2004	0	Pulse oximetry: 100% in room air;	PVT	PVT	NONE	NONE	History of eczema;			1						1	Agitation; Erythema; Eye oedema; Face oedema; Hypersensitivity; Oedema peripheral; Rash macular; Rash papular	FLU3~SANOFI PASTEUR~U1377A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228139	10/25/2004	MA	5.0	4		M	10/06/2004	Rash appeared at injection site left arm down to 5cm before wrist. Pt did not complain of any discomfort. No pain at site, just redness. Remained for 10-15 minutes then rash disappeared.									Y	10/06/2004	10/06/2004	0	NONE	PUB	PUB	NONE	Otitis Media;	Mild intermittent asthma; Recurrent otitis;			1						1	Erythema; Rash	FLU3~SANOFI PASTEUR~U1439AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228140	10/25/2004	MD	66.0	65		F	10/15/2004	Redness right arm at 9pm 10/04/04.  Followed by pain and swelling on 10/05/04 at 7AM, lasting for 5 days. Decreased redness with some itching as of 10/15/04.									Y	10/04/2004	10/05/2004	1	UNK	PUB	PUB	UNK	UNK	UNK			1						1	Injection site erythema; Injection site oedema; Injection site pain; Pruritus	FLU3~SANOFI PASTEUR~U1418AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1138N~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0228141	10/25/2004	TX	82.0	81		F	10/18/2004	Moderate asthma attack (allergies to eggs). Treated with a shot and with oral medication. (Hydroxyl HCL 25mg). Dear sirs: It was ridiculous of me to have reported this incident. I've had asthma (diagnosed Jan 1978) and I am allergic to eggs. Very simple. So I've had my last flu shot.				Y					Y	10/04/2004	10/06/2004	2	NONE	MIL	OTH	UNK	NONE	Asthma; Allergy to eggs;			1						1	Asthma; Condition aggravated	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0228231	10/25/2004	MD	50.0	50		F	10/25/2004	unknown to me at this time. Nurse follow up on 10/29/04 states: multiple lacunar infarcts in the thalami, (L) caudate head & periventricular white matter; transverse myelitis; hypertension; hyperlipidemia; pain & numbness; weakness of lower extrem; difficulty walking. Autopsy Report received on 12/07/2004 states severe acute CHF, bilateral acute ischemic renal infarcts, severe pulmonary congestion and edema, severe congestion, liver and spleen, and circulatory collapse. 11/18/04 Lab reports received. No new evidence found.	Y	10/20/2004			Y				N	10/08/2004			unknown to me at this time	UNK	UNK	unknown	unknown	Sciatica, HTN			1						1	Cardiac failure; Cerebral infarction; Circulatory collapse; Gait disturbance; Hyperlipidaemia; Hypertension; Lung disorder; Myasthenic syndrome; Myelitis transverse; Pain; Paraesthesia; Pulmonary oedema; Renal impairment; Blood pressure decreased; Laboratory test abnormal; Malaise	FLU3~SANOFI PASTEUR~U1489AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1489AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0228233	10/25/2004	OH	70.0	70		F	10/25/2004	Flu shot given on 10/21/2004 approx. 1000am Pt. states headache right away and hives by 1400 on 10/21/2004 still with rash and itching started today(10/25). Denies any breathing difficulties, did not see a doctor or call one. PHN strongly encouraged her to call her PCP. Called ODH; said to do a VAERS.									U	10/21/2004	10/21/2004	0		UNK	UNK	Anatripalene,Placil,Colinetrisal all per pt.	pt. denies	Cataract, Glucagoma, denies any new foods or any new medications and change in soaps, lotions etc. However she mentioned that she has had tx. for enviormental allergies within last 4-6 weeks.			1						1	Headache; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1459AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228236	10/25/2004	PA	75.0	75		F	10/25/2004	ED VISIT FOR ITCHY PALMS, TIGHT AND ITCHY THROAT, SWELLING AROUND RIGHT EYE, WHEEZING;  TREATED WITH METHYLPREDNISOLONE 125 MG, DIPHENHYDRAMINE 12.5 MG X 2; ALBUTEROL TREATMENT;  DISCHARGED ON PREDNISONE 20 MG BID X 2 DAYS AND ANTIHISTAMINE OF CHOICE; HAS PREVIOUSLY RECEIVED INFLUENZA VACCINE WITHOUT REACTION				Y					Y	10/19/2004	10/19/2004	0		UNK	UNK	NEXIUM, LIPITOR, METOPROLOL, PROTONIX	NONE	CARDIAC STENT, HYPERTENSION, REFLUX, HYPERCHOLESTEROLEMIA; PENICILLIN AND ERYTHROMYCIN ALLERGIES			1						1	Eye oedema; Pruritus; Throat tightness; Wheezing	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0228239	10/25/2004	CO	49.0	49		F	10/25/2004	Employee had immediate reaction to administration of flu vaccine on 10/19/04. She felt burning at the injection site, then in the affected arm and up into her neck. Sent her to the ED where she was treated and admitted with allergic reaction, for administration of steroids and breathing treatments. Employee was admitted to inpatient and received medications for SOB. Discharged on 10/21/04. Discharge summary states neck tight, allergic reaction, difficulty breathing and itching. msv				Y	Y	2			Y	10/19/2004	10/19/2004	0	Medical records state abnormal lab results. msv	UNK	UNK		N/A	N/A Medical records state cytomegaly viral infection. msv			1						1	Dyspnoea; Hypersensitivity; Injection site pain; Laboratory test abnormal; Neck pain; Pruritus; Thermal burn; Throat tightness	FLU3~SANOFI PASTEUR~U1451AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0228241	10/25/2004	NY	1.59	1	.6	F	10/25/2004	Parents reported that within 24 hours of vaccines that pt began acting strangely, including flapping arms, hitting herself, biting.									U	10/01/2004	10/01/2004	0	Pt saw neuro- results pending	UNK	UNK		none	none			1						1	Abnormal behaviour; Convulsion; Movement disorder; Pyrexia; Speech disorder	DTAP~GLAXOSMITHKLINE BIOLOGICALS~514B9~4~IM~UN~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1383AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A74399C~4~IM~UN~PNEUMO (PREVNAR)~1|DTAP~SMITHKLINE BEECHAM~A614B9~4~UN~UN~DTAP (INFANRIX)~2|FLU3~SANOFI PASTEUR~U1383AA~3~SYR~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|PNC~PFIZER\WYETH~A74399C~4~UN~UN~PNEUMO (PREVNAR)~2	USA		Influenza
0228242	10/25/2004	KS	46.0	45		F	10/25/2004	Individual raised red bumps on trunk and neck. Minimal itching/no treatment @ this time.									N	10/21/2004	10/22/2004	1		UNK	UNK	advil 400 mg 10/20/04 PM	none	none			1						1	Pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~U1451AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228244	10/25/2004	WY	52.0	52		F	10/25/2004	Site Reaction, Flu-like symtoms, chills,sweats, headache, hoarseness, post nasal drip, cough, asthma like at times (increased use of Albuterol)									N	10/22/2004	10/22/2004	0		UNK	UNK	Premarin, Zyrtec,Advair,Albuterol,Singulair		Many allergies			1						1	Asthma; Chills; Cough; Dysphonia; Headache; Hyperhidrosis; Influenza like illness; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~?~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0227911	10/26/2004	IL	66.0	66		F	10/25/2004	Patient has history of leiomyosarcoma of uterus with lung metastasis. 9/28 had Gemzar and Taxotene. 9/30 flu vaccine. 10/8 flu like symptoms (cough, myalgia, fever and fatigue. 10/9 unable to walk; received Aleve, Tylenol, Advil, Robitussin. 10/11 minor transient blurriness of vision; resolved within 30 minutes. 10/12 admitted with HgB 44, transferred.				Y	Y	4			Y	09/30/2004	10/08/2004	8	Hgb 4.4; SGOT 69; SGPT 101; Alk Ph 233; LDH 37.6; Positive cold agglutinuria.	OTH	OTH	Nexium 20mg qd.	Leiomyosarcoma of uterus.	NONE			1						2	Anaemia; Anxiety; Asthenia; Cough; Difficulty in walking; Dyspnoea; Fatigue; Haemolytic anaemia; Influenza like illness; Laboratory test abnormal; Liver function test abnormal; Myalgia; Pharyngitis; Pyrexia; Rhinitis; Vision blurred; Abasia; Cough; Fatigue; Influenza like illness; Laboratory test abnormal; Myalgia; Pyrexia; Vision blurred	FLU3~SANOFI PASTEUR~U1418AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0228183	10/26/2004	MI	0.63	0	.6	F	10/21/2004	From initial information received on 10/18/04 from a healthcare facility regarding an adverse event occurring in the USA, it was reported that a 7 month old female patient received FLUZONE SV 2004-2005, lot number U1407AA, on 10/12/04. The route and site of administration were not reported. An unspecified amount of time later, the patient was seen by a surgeon at a hospital and was diagnosed with intussusception of the bowel. It is unknown if the patient was actually admitted, however, the reporter stated that she believed she was. No other details were provided. The reporter stated that she believes the patient recovered from this event.  Follow up on 11/12/04 states: From additional information received on 11/04/04 from a health care professional, the vaccine was administered in the pt's left leg on 10/12/04 at 12:00 in the afternoon. Four days later on 10/16/04 at 3:00AM, the pt developed intussusception of the bowel. No other medical information was provided at this time.				Y	Y				Y	10/12/2004				PVT	PVT			The patient has no relevant past medical history. She did have a ear infection on 9/10/04 and was treated with amoxicillin. That same day, the patient received a dose of DAPTACEL, lot number C1698AA; Hepatitis B vaccine, lot number 0145P; IPOL, lot number K1038 and PCV, lot number A57599B.		200403398	1						1	Intussusception	DTAP~SANOFI PASTEUR~C1698AA~UNK~~~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1407AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0145P~UNK~~~HEP B (RECOMBIVAX HB)~1|IPV~SANOFI PASTEUR~X1038~UNK~~~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~A57599B~UNK~~~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0228187	10/26/2004	OH	73.0	73		M	10/11/2004	Septic shock syndrome, Acute renal failure, acute tubular necrosis. Non-Q myocardial infarction. Discharge Summary received on 12/07/2004 states hyperglycemia, acidosis, atrial fibrillation, lung dis, atelectasois, and CHF. Medical Records received on 12/07/2004 states rash, fever, SOB, lethargy and itching.			Y	Y	Y				Y	10/04/2004	10/05/2004	1	Discharge Summary received on 12/07/2004 states cardiac labs abnormal. Medical Records received on 12/07/2004 states elevated WBC.	PVT	PVT	Prinivil; Tenoretic; Lopid; Lipitor; Zyloprim; Trentac	NONE	Gout; NKDA; Hypertension; Hyperlipidemia; Renal insufficiency. Discharge Summary received on 12/07/2004 states valve regurgitation. Medical Records received on 12/07/2004 states obese.			1						1	Acidosis; Atelectasis; Atrial fibrillation; Cardiac failure; Dyspnoea; Hyperglycaemia; Laboratory test abnormal; Lethargy; Lung disorder; Myocardial infarction; Pruritus; Pyrexia; Rash; Renal failure; Renal tubular necrosis; Sepsis; Shock; White blood cell count increased	FLU3~SANOFI PASTEUR~U1446AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0228189	10/26/2004	TX	10.0	10		F	10/06/2004	Red erythematous area 3 1/2 diameter around injection site. Tender, no fever. Cool compresses, observe.									U	10/05/2004	10/06/2004	1		PVT	PVT		NONE				1						1	Injection site erythema; Tenderness	FLU3~SANOFI PASTEUR~U1410BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228190	10/26/2004	TX		4		M	09/30/2004	redness and edema to left upper thigh, front area approx 4x3 warm and tender to touch pt c/o pain/discomfort.									U	09/28/2004	09/29/2004	1		PVT	PVT						1						1	Feeling hot; Injection site erythema; Injection site oedema; Injection site pain; Tenderness	DTAP~SANOFI PASTEUR~C1700AA~5~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~V1418AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1006~4~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0415P~2~IM~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0228191	10/26/2004	PA	75.0	75		M	10/21/2004	Redness, swelling, warmth, tenderness of right upper extremity above and below vaccine site. Covers entire tricep region.									U	10/20/2004	10/21/2004	1	NONE	PVT	UNK	Detrol LA 4 mg CAPCR24 (Tolterodine Tartrate) one tab daily (last refill: 06/30/04 90x3); Ativan Tab 0.5mg (Lorazepam) 1q 6h prn nerves (last refill: 07/23/01 30x5); Viagra 100mg tab (Sildenafil Citrate) as directed (last refill: 07/29/02 1		Deprsv. Disord. Sngl epsid., full remission, hypertension, benign essential, supraventricular tachycardia, hyperlipidemia NOS, BPH, screening for malignant neoplasm prostate, aortic valve disorder, nocturia, elevated prostate specific antigen, femoral bruit left, occlusion arterial branch retina, aneurysm thoracic aortic, abnormal result function study CV NOS, screening for malignant neoplasm prostate, minor dx of local reaction to pneumonia injection.			1						1	Feeling hot; Injection site erythema; Injection site oedema; Tenderness	FLU3~SANOFI PASTEUR~U1457AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0947N~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0228192	10/26/2004	NJ	8.0	8		F	10/21/2004	Rec'd influenza vaccine 10/18/04 developed redness, swelling (5cm) on right upper deltoid.				Y					Y	10/18/2004	10/19/2004	1		PVT	PVT		NONE	Seasonal allergies, takes Singulair			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U14009BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228193	10/26/2004	GA	56.0	56		F	10/13/2004	3 hours after shot, large knot on side of neck appeared.									Y	10/13/2004	10/13/2004	0	Parkinson Disease	PVT	UNK		NONE				1						1	Injection site mass; Parkinsonism	FLU3~SANOFI PASTEUR~U1448AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228194	10/26/2004	TX	77.0	77		F	10/24/2004	Administered Pneumonia shot in left arm at about 2:30PM 10/22/04. Pt noticed around Friday evening left arm from shoulder down turned red and some swelling. Pneumococcal vaccine polyvalent Pneumovax 23 Lot 0513P ex 03/09/06.									Y	10/22/2004	10/22/2004	0		OTH	OTH	Thyroid med, Lipitor, Celebrex	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site reaction	FLU3~SANOFI PASTEUR~U1500AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0513P~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0228195	10/26/2004	AZ	4.0	4		F	10/25/2004	Right upper arm swollen, indurated, painful, erythematous within 24 hours of immunizations. No fever, limited ROM, swelling, redness and erythema, extended from antesubterol to above shoulder joint. Treated with Augmentin for a presumed cellulitis and Benadryl.									Y	10/21/2004	10/22/2004	1		PVT	PVT	NONE	NONE	NONE			1						1	Cellulitis; Erythema; Injection site mass; Joint range of motion decreased; Oedema; Pain	DTAP~GLAXOSMITHKLINE BIOLOGICALS~34A2~5~IM~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1439AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X10062~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0415P~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0228196	10/26/2004	CA	1.35	1	.3	M	10/25/2004	On 10/18/04 pt received Influenza vaccine. He became irritable and febrile. On 10/20/04, he had a generalized seizure with fever (105F)				Y					Y	10/18/2004	10/18/2004	0	NONE	PVT	UNK		NONE	NONE			1						1	Convulsion; Irritability; Pyrexia	FLU3~SANOFI PASTEUR~U1440AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228197	10/26/2004	KY	28.0	27		F	10/22/2004	Left arm numbness from shoulder to fingertips, painful.				Y					U	10/20/2004			NONE	PUB	PUB	Iron Meds	Pregnant	Latex Allergy, asthma, pregnant			1						1	Hypoaesthesia; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0228198	10/26/2004	IL	2.0			F	10/22/2004	30-45 min post influenza admin (pt's 3rd dose) pt experienced pruritus, interior flushing, redness of face, hives, wheezing.				Y					Y				oxygen sat decreased	PUB	PUB		Eval URI (U track secretions); fever, cough, wheezing;	Myelomeningocele, IPS, L VUR, Tracheostomy; IBS;			1						1	Erythema; Flushing; Hypoxia; Pruritus; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U1458AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|UNK~UNKNOWN MANUFACTURER~401580~7+~~~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0228199	10/26/2004	AZ	1.11	1	.1	M	10/22/2004	Facial edema, scrotal edema, body rash at creases, gave 0.1mg Epinephrine SQ x1 and sent to ER.  Nurse follow up on 11/12/04 states: no new information.				Y					U	10/22/2004	10/22/2004	0		PVT	PUB		NONE	Pfieffer syndrome			1						1	Face oedema; Rash; Scrotal oedema	FLU3~SANOFI PASTEUR~U1407AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228200	10/26/2004	AZ	0.58	0	.6	M	10/22/2004	x2 seizures lasting 15 minutes at home. Body shaking with starring, some apnea, duskiness, lethargic afterwards. Paramedics called both times. No treatment. (01:30 and 08:00 10/22/04).				Y					Y	10/21/2004	10/22/2004	1	NONE	PVT	PUB	NONE	NONE	Pyloric stenosis, GER, took Zantac x 2 months then stopped.			1						1	Apnoea; Convulsion; Cyanosis; Gaze palsy; Lethargy	DTAP~SANOFI PASTEUR~U1300AA~2~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1407AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0145P~3~IM~RL~HEP B (RECOMBIVAX HB)~1|IPV~SANOFI PASTEUR~X0799~2~SC~LL~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0228201	10/26/2004	CO	7.0	6		F	10/25/2004	6 year old female with meningoencephalitis (cause unknown) who has been recovering over last 2.5 months. She received the vaccine and developed more encephalopathic symptoms about 8 hours after receiving the vaccine. She is 11 days out from vaccine and still has slurred speech, word-finding difficulty, gait difficulties, etc. Discharge Summary received on 12/07/2004 states abdominal pain, leg pain, fever, headache, stiff neck, unresponsive, irritable, sleepy, decreased stregnth, decreased po intake, urinary retention, and bladder spasm. Medical Records received on 12/07/2004 states vomiting. Follow up 03/04/05: Patient has almost completely recovered. She still has some fine motor and cognative deficits. We did give her a prolonged course of steroids after her MRI was consistent with Acute Demyelinating Encephalomyelitis. She has improved neurologic function. Per annual follow report 1/26/2006 She still has subtel cognitive/processing problems, she has balance issues.				Y	Y	1			N	10/14/2004	10/14/2004	0	ESR 28. Discharge Summary received on 12/07/2004 states CSF abnormal and EBV IgG positive. Medical Records received on 12/07/2004 states EEG abnormal.	PUB	OTH	NONE	2.5 months out from #19.	Meningoencephalitis			1						1	Abdominal pain; Asthenia; Balance disorder; CSF test abnormal; Cognitive disorder; Coma; Condition aggravated; Dehydration; Dysarthria; Electroencephalogram abnormal; Encephalitis; Gait disturbance; Headache; Irritability; Musculoskeletal stiffness; Pain; Pyrexia; Somnolence; Speech disorder; Urinary retention; Viral infection; Vomiting	FLU3~SANOFI PASTEUR~U1417AA~3~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0228202	10/26/2004	TX	63.0	62		F	10/25/2004	Pt noticed itching and redness to injection site, bigger than 50 cent, on 10/23/04 at around 8:30AM. Pt called today and advised to take Benadryl 25  ever 5 hours no SOB or any resp distress, no fever. Advised to call all if symptoms worsens. Treatment just started today (10/25/04)									U	10/22/2004	10/23/2004	1		PVT	PVT	Multiple Meds	NONE	Allergies: Sulfa, cortisone, Flagyl, Meclizine, Denerol.			1						1	Injection site erythema; Pruritus	FLU3~SANOFI PASTEUR~U1446AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228203	10/26/2004	TX	54.0	53		F	10/25/2004	Pt noticed redness, lump, to injection site about 3 inches wide. No respiratory distress or fever. Pt received injection on 10/22/04 at 3:00PM. Pt noticed reaction the next day 10/23/04 at about 8 AM. Advised to take Benadryl 25m every 6 hrs. Treatment started today. (Benadryl)									U	10/22/2004	10/23/2004	1		PVT	PVT	Ativan, Zyrtec, Albuterol, Ibuprofen, Advair		Allergies: Penicillin			1						1	Injection site erythema; Injection site mass	FLU3~SANOFI PASTEUR~U1446AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228204	10/26/2004	TN	76.0	76		F	10/25/2004	Local hospital reported that pt had no prior cardiac history. 10/26/04 Spoke the reporter/provider for this death.  The only information their clinic has on the decedent's prior medical hx is that she did not check off any of the items listed under medical history on the vax permission sheet including those asking about cardiac problems. She did not list any current meds. This woman was the aunt of one of the other health dept. nurses and this nurse has apparently stated that she is unaware of any health problems for her aunt. They are not aware of the name of her PMD. The reporter states that an autopsy was not done. We have requested the hospital records. 10/27/04 Copies of the ER report and the code blue record and death summary are received and sent for scanning. She arrived at the ER at 8:50 AM and expired at 10:48 AM in the CATH lab. The attending physician's summary notes COD most likely an inferior posterior acute myocardial infarction based on ECHO and presenting sxs. Family was apparently advised that she was in cardiogenic shock w/ a small chance for survival without therapy. A temp pacemeaker, intra-aortic balloon pump and possibly salvage angioplasty were planned. In between insertion of the pacemaker and beginning of the angioplasty, she was found to have no pulse by palpation and confirmed on EKG and prolonged code was unsuccessful. Please refer to the scanned records for details.  10/27/04 Call to funeral director to request copy of Death Certificate. This record is received and notes Myocardial Infarction as the COD. Neither the hospital record, the original VAERS reporter nor the hospital attending who signed the Death Certificate know who the PMD was for this woman. I placed a call to the son today. There was no answer and no VM.  Died of a massive MI on Tuesday morning 10/19/04 while in store.	Y	10/19/2004							N	10/18/2004	10/19/2004	1	NONE	PUB	PUB		NONE	NONE		TN04052	1						1	Myocardial infarction	FLU3~SANOFI PASTEUR~U1503AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0228205	10/26/2004	TN	76.0	75		F	10/25/2004	Local hospital reported patient had no prior cardiac history. Patient was found in her bed around noon on Tuesday, 10/19. They believed she had died from a hemorrhagic stroke early Tuesday morning.  Nurse follow up on 10/27/04 states: intracranial hemorrhage.	Y	10/19/2004							N	10/18/2004	10/19/2004	1	NONE	PUB	PUB		NONE	NONE		TN04053	1						1	Cerebrovascular accident; Haemorrhage; Haemorrhage intracranial	FLU3~SANOFI PASTEUR~U1419AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0228206	10/26/2004	WI	0.79	0	.8	M	10/25/2004	Hives and rash within 5 minutes of receiving vaccine.									Y	10/25/2004	10/25/2004	0		PVT	OTH		NONE	Medical Record received on 12/02/2004 statesreflux and allergic response to vax.	hives~DTaP + Hib (no brand name)~2~0.00~In Patient		1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~U1415AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228207	10/26/2004	WY	43.0	42		F	10/22/2004	Swollen, red, hot deltoid, cellulitis.  Follow up on 10/28/04 states: Problem at pneumovax site.									Y	10/13/2004			NONE	PVT	PVT	Prednisone	L LL pneumonia, bronchitis				1						1	Cellulitis; Feeling hot; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1462AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0987N~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0228249	10/26/2004	OK	31.0	30		F	10/26/2004	4-5 days after receiving vaccine, developed intermittent unproductive cough with mucous taste; 8 days after receiving vaccine, developed moderately high fever (101.5 orally) which lasted approximately 12 hours until it was lowered to 99.5 with 2 Advil.  Fever remained at approximately 99.5 - 100 for next 24 hours, then broke.  Back pain developed during fever, still moderately present.  Neck pain developed at end of fever, still quite painful and causing headaches.									N	10/16/2004	10/20/2004	4		UNK	UNK				same, but with sore throat~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Back pain; Cough; Headache; Neck pain; Pyrexia	FLU3~SANOFI PASTEUR~U1463AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228252	10/26/2004	CA	84.0	83		F	10/26/2004	After giving vaccine, injection site enlarged immediately. Appeared bruised.  Patient remained in pharmacy 15 minutes for follow-up.  Patient had flu shots in past history with no adverse reaction.  Injection site appeared to shrink slightly. Told patient to take Benadryl and to put ice on site. Told patient to follow-up with MD if problem persists or worsens.									U	10/26/2004	10/26/2004	0		UNK	UNK						1						1	Contusion; Injection site swelling	FLU3~SANOFI PASTEUR~U1504AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227788	10/27/2004		54.0			F	11/18/2004	From initial information received on 10/19/04 from another manufacturer regarding an adverse event occurring in the USA, it was initially reported by a health care professional that a 54 year old female patient received a dose of FLUZONE, lot number not reported, as well as a dose of PNEUMOVAX 23, lot number 647359/0740N administered IM on 9/28/04. Both products were administered in the same arm. One day later, on 9/29/04, the patient developed lymph node swelling and fever. The patient was seen in the emergency room and was noted to be hospitalized. At the time of this report, the patient had not recovered. The records to testing prior to release of PNEUMOVAX 23, lot number 0740N, have been checked and found to be satisfactory. The lot complied with the standards and was released. The events of lymph node swelling and fever were considered by the other company to be immediately life threatening and disabling. From additional information received on 12Nov04 from a health care professional, it was reported that there are no adverse events to report. In addition, the reporter's telephone number initially reported by another manufacturer is not the correct number. From additional information received on 15Nov04 through email correspondence from another manufacturer, a new telephone number for the initial reporter was provided. No additional information is anticipated, this case is considered closed. The reporter of this case is the same as for cases 2004-03408, 2004-03409, 2004-03410 and 2004-03473.			Y	Y	Y		Y	Y	N	09/28/2004	09/29/2004	1	UNK	OTH	OTH			The patient's past medical history was reported as unknown.		200403407	1						2	Lymphadenopathy; Pyrexia; Lymphadenopathy; Pyrexia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0740N~UNK~IM~~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0740N~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0227789	10/27/2004	CO	67.0			F	10/25/2004	From initial information received on 10/19/04 from another manufacturer regarding an adverse event occurring in the USA, it was initially reported by a health care professional that a 67 year old female patient received a dose of FLUZONE, lot number not reported, as well as a dose of PNEUMOVAX 23, lot number 647359/0740N, administered IM on 9/28/04. Both products were administered in the same arm. One day later, on 9/29/04, the patient developed lymph node swelling and fever. The patient was seen in the emergency room and was noted to be hospitalized. At the time of this report, the patient had not recovered. The records of testing prior to release of PNEUMOVAX 23, lot number 0740N, have been checked and found to be satisfactory. The lot complied with the standards and was released. The events of lymph node swelling and fever were considered by the other company to be immediately life-threatening and disabling. Fom additional information received on 15NOV2004 form a health care professional, it was reported that there are no adverse events to report. In addition, the reporter's telephone number initially reported by another manufactureris not the correct number. A new telephone number was provided. From additional informaiton received from a telephone communication form the initial reporter on 17NOV2004, it was reported that the reaction was due to administering both vaccines in the same arm that was an error on their part. All of these patients have recovered. No additional informaiton is anticipated, this case is considered closed. The reporter of this case is the same reporter as cases 200403407, 200403408, 200403410 and 200403473.			Y	Y	Y		Y	Y	Y	09/28/2004	09/29/2004	1	UNK	UNK	UNK			It is unknown if the patient had any significant past medical history or illnesses at the time of vaccination.		200403409	1						2	Lymphadenopathy; Pyrexia; Lymphadenopathy; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0740N~UNK~~~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0740N~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0227790	10/27/2004	CO				F	10/25/2004	From initial information received on 10/19/04 from another manufacturer regarding an adverse event occurring in the USA, it was initially reproted by a health care professional that a female patient in her late 60's (exact age not reported) received a dose of FLUZONE, lot number not reported, as well as a dose of PNEUMOVAX 23, lot number 647359/0740N administered IM on 9/28/04. Both products were administered in the same arm. One day later, on 9/29/04, the patient developed lymph node swelling and fever. The patient was seen in the emergency room and was noted to be hospitalized. At the time of this report, the patient had not recovered. THe records of testing prior to release of PNEUMOVAX 23, lot number 0740N, have been checked and found to be satisfactory. The lot complied with the standards and was released. The events of lymph node swelling and fever were considered by the other company to be immediately life threatening and disabling. From additional information received on 12NOV2004 from a health care professional, it was reported that there are no adverse events to report. In additiion, the reporter's telephone number initially reported by another manufacturer is not the correct number. From additional information received on 15NOV2004 through email correspondence from another manufacturer, a new telephone number for the initial reporter was provided. From additional information receive from a telephone communication from the initial reporter on 17NOV2004, it was reported that the reaction was due to administering both vaccines in the same arm that was an error on their part. All of these patients have recovered. No additional information is anticipated, thiscase is considered closed.			Y	Y	Y		Y	Y	Y	09/28/2004	09/29/2004	1	UNK	UNK	UNK			It is unknown if the patient had any significant past medical history or illnesses at the time of vaccination.		200403410	1						2	Lymphadenopathy; Pyrexia; Lymphadenopathy; Medication error; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0740N~UNK~IM~~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0740N~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0227791	10/27/2004		68.0			F	10/25/2004	From initial information received on 10/19/04 from another manufacturer regarding an adverse event occurring in the USA, it was initially reported by a health care professional that a 68 year old female patient received a dose of FLUZONE, lot number not reported, as well as a dose of PNEUMOVAX 23, lot number 647359/0740N administered IM on 9/28/04. Both products were administered in the same arm. One day later, on 9/29/04, the patient developed lymph node swelling and fever. The patient was seen in the emergency room and was noted to be hospitalized. At the time of this report, the patient had not recovered. The records of testing prior to release of PNEUMOVAX 23, lot number 0740N, have been checked and found to be satisfactory. The lot complied with the standards and was released. The events of lymph node swelling and fever were considered by the other company to be immediately life threatening and disabling.From additional information received on 12NOV2004 from a health care professional, it was reported that there are no adverse events to report. In additiion, the reporter's telephone number initially reported by another manufacturer is not the correct number. From additional information received on 15NOV2004 through email correspondence from another manufacturer, a new telephone number for the initial reporter was provided. From additional information receive from a telephone communication from the initial reporter on 17NOV2004, it was reported that the reaction was due to administering both vaccines in the same arm that was an error on their part. All of these patients have recovered. No additional information is anticipated, thiscase is considered closed.			Y	Y	Y		Y	Y	Y	09/28/2004	09/29/2004	1	UNK	OTH	OTH			It is unknown if the patient has any pre-existing physician diagnosed allergies, birth defects or medical conditions.		200403408	1						2	Lymphadenopathy; Pyrexia; Lymphadenopathy; Medication error; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0740N~UNK~IM~~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0740N~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0227901	10/27/2004	VA	47.0	46		F	11/04/2004	From initial information received on 10/18/04 from a nurse regarding an adverse event occurring in the USA, it was reported that a 46 year old female patient received a FLUZONE vaccination, lot number U1377AA, administered IM at approximately 2:00 PM on 10/8/04. The site of administration was not reported. On 10/9/04, at 6:00 AM, the patient awoke feeling achy and had diarrhea off and on. She took Tylenol and felt somewhat better. Soon after this she felt achy and weak and stated that her legs felt funny. Her legs and elbows felt shaky, as if her blood sugar was low. She then donned a gown and gloves for a procedure and became very hot and she sat down for a few minutes. The patient stated she had to lay down and laid down across a desk and called an outpatient facility for help. She proceeded to have nausea and dry heaves and states she couldn't hold her head up. She tried to get up to go to the bathroom, but said she couldn't stand. After using the bathroom, she said she couldn't pull her pants up. The patient was taken to the emergency department, where she felt numb from her knees down, and from her elbows down. At this point, she stated she was unable to move anything except her head. After a liter of fluids, she felt somewhat better, but was admitted to the ICU overnight, as her physician felt she may have had an acute onset of GBS, which was ruled out. The following day, the patient was able to move and had sensation back. She was moved to a medical/surgical floor and was discharged on Monday, 10/11/04. The patient's medical doctor stated he found nothing and referred her to a psychiatrist who also cleared her. When the patient called the reporter on 10/18/04, she stated that she still felt weak, had frequent headaches, neck pain, and felt woozy the prior evening. Her right hand and both feet felt numb at times. On Friday, 10/15/04, she experienced a lot of rib pain and it hurt to take a deep breath. She reported that a neurologist stated she may have contracted the flu from the flu shot, as her immunity may have been down from a stomach virus earlier the week she had the shot. The patient denies having any fever, sore throat, cough or cold symptoms. She related that while experiencing the paralysis, she was told that she was hyper-reflexive. The patient has not recovered. From additional information received on 01Nov04 from a telephone contact with the initial reporter, it was reported that the pt has fully recovered and has returned to work. She became anxious and she hyperventilated after receiving the vaccine, which caused the other symptoms. She was seen by a neurologist at the hospital and a psychological consult was ordered. The reporter does not have the pt's hospital records, but has provided the name of the person whom to request this information.				Y	Y	3			Y	10/08/2004	10/09/2004	1		OTH	PVT	Effexor; Synthroid; Prevacid; Estradiol; Lasix; Toprol XL		The patient is allergic to codeine. Her past medical history includes GERD, depression, hypothyroidism, and an irregular heart beat. Per the patient, she had experienced an unspecified reaction years ago when the vaccine was still a live virus, but has since received it without any problem. The patient reported that she had a stomach ache the Tuesday prior to receiving the Influenza vaccine, but thought she was ok on the date of vaccination. Follow up 01Nov04: The pt had a gastrointestinal virus at the time of vaccination and after the vaccine had some generalized aches that frightened her.	she had experienced an unspecified reaction~Influenza (Seasonal) (no brand name)~~0.00~In Patient	200403396	1						2	Anorexia; Chest pain; Conversion disorder; Diarrhoea; Dizziness; Feeling hot; Headache; Hyperreflexia; Hypoaesthesia; Hypokinesia; Muscular weakness; Nausea; Neck pain; Pain; Retching; Tremor; Anxiety; Asthenia; Diarrhoea; Dizziness; Headache; Hyperventilation; Hypokinesia; Nausea; Neck pain; Pain; Retching	FLU3~SANOFI PASTEUR~U1377AA~7+~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1377AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0228271	10/27/2004	NY	4.0	4		M	10/20/2004	Developed mild fever, marked swelling and erythema of left upper extremity. Hospitalized 10/16 through 10/18/04. IV Oxacillin, PO Benadryl, and Ibuprofen. Discharged on 7 day course of Augmentin, Benadryl PRN. I believe patient had a combination of a large local inflammatory reaction and possible cellulitis. Full recovery by 10/19/04.  Nurse follow up on 11/01/04 states: Pain.				Y	Y	3			Y	10/14/2004	10/15/2004	1	CBC NL; WBC 10.6; ESR 26; Blood culture negative.	PVT	PVT	NONE	NONE	Possible RAD; Allergic Rhinitis			1						1	Cellulitis; Erythema; Inflammation; Pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U1419AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0044P~2~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Hospitalisation	Influenza
0228272	10/27/2004	CA	1.62	1	.6	F	10/19/2004	Refusal to get out of bed or walk for almost 16 hours, refusal to eat for less than 24 hrs treated with Motrin (initially started with limping).				Y					U	10/18/2004	10/18/2004	0		PVT	PVT		NONE	NONE			1						1	Anorexia; Difficulty in walking	DTAP~SANOFI PASTEUR~U1258CA~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1391AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0095P~4~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~A74398K~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0228273	10/27/2004	CO	37.0	36		F	10/19/2004	Severe swelling/ pain in right deltoid where Pneumovax given. Fever to 101.									U	10/18/2004	10/18/2004	0		PVT	PVT		NONE	NONE			1						1	Injection site oedema; Injection site pain; Injection site reaction; Pyrexia	FLU3~SANOFI PASTEUR~U1417AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0371P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0228274	10/27/2004	PA	4.0	4		F	10/19/2004	After few minutes of getting shots she developed hives, had nausea and vomiting, no difficulty breathing. Benadryl given, refused O2, 911 called, sent to ER where given Solumedrol. Sent home on Orapred x 3 days. Medical records state allergic reaction. msv				Y					Y	10/18/2004	10/18/2004	0		PVT	PUB	Keppra for s2		spina bifida  Medical records state Hx of allergic reaction. msv			1						1	Hypersensitivity; Nausea; Urticaria; Vomiting	DTAP~GLAXOSMITHKLINE BIOLOGICALS~639B2~5~~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1499AA~3~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X08002~4~~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1186N~2~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0228275	10/27/2004	NJ	48.0	48		F	10/19/2004	Redness, warmth, elevation of 30mm appearing within 24 hours and disappearing 48 hours later.									Y	10/06/2004	10/07/2004	1		UNK	UNK		NONE	NONE			1						1	Erythema; Feeling hot; Oedema	FLU3~SANOFI PASTEUR~U1501AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228276	10/27/2004	CA	66.0	66		U		Severe pain in arm, swelling in arm twice the size very red. I couldn't even move my arm it hurt so bad. 100.8 temp. It was in the right arm nurse said it was pneumococcal. Influenza shot was in left arm. Was better in 3 days, took Tylenol for pain.									Y	10/16/2004	10/16/2004	0	NONE	PUB	OTH	Atenolol, Zocor, Cumadine	NONE	Hans Atrial Fiberration			1						1	Hypokinesia; Injection site erythema; Injection site oedema; Injection site pain; Injection site reaction; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0228277	10/27/2004	NJ		37		F	10/19/2004	Redness, warmth, elevation of 30mm appearing within 24 hours and disappearing 48 hours later.									Y	10/06/2004	10/07/2004	1		UNK	UNK		NONE	NONE			1						1	Erythema; Feeling hot; Oedema	FLU3~SANOFI PASTEUR~U1501AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228278	10/27/2004	OH	25.0	25		F	10/20/2004	After receiving flu vaccine within 18 hours left arm site became red, inflamed, hard, tender to touch, cellulitis, started on antibiotics.									Y	10/04/2004	10/05/2004	1		PUB	PVT	Allegra, Orthotrycyclin, Cenflun.	NONE	Allergies to medication Biaxin, tape, bee stings.			1						1	Cellulitis; Injection site erythema; Injection site inflammation; Injection site mass; Tenderness	FLU3~SANOFI PASTEUR~M1409BA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228279	10/27/2004	UT	5.0	4		F	10/15/2004	Within minutes of receiving influenza vaccine pt became flushed c/o difficulty breathing, edema and urticarial s/s face. Epinephrine 1:1000 1.5ml vastus lateralis given. Pt immediately reported decrease SOB, edema. Discharge summary states anaphylaxis. msv Medical records state laryngitis, increased coughing, vomiting. msv				Y					Y	10/15/2004	10/15/2004	0		PVT	PVT		NONE	Charge Syndrome, Pulmonary Artresa, vesicoureteral reflux, growth hormone Discharge summary states congenital anomaly, parathyroid disease, blind, deaf, condition of hypocalemia. msv			1						1	Anaphylactic reaction; Cough; Dyspnoea; Flushing; Laryngitis; Oedema; Urticaria; Vomiting	FLU3~SANOFI PASTEUR~U1447AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228280	10/27/2004	NJ	29.0	28		F	10/19/2004	Redness, warmth, elevation 30mm appearing within 24 hours and disappearing 48 hours later.									Y	10/06/2004	10/07/2004	1		OTH	OTH						1						1	Erythema; Feeling hot; Oedema	FLU3~SANOFI PASTEUR~U1501AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228281	10/27/2004	NJ		30		F	10/19/2004	Redness, warmth, elevation of 30mm appearing within 24 hrs and disappearing 48 hrs later.									Y	10/06/2004	10/07/2004	1		UNK	UNK		NONE	NONE			1						1	Erythema; Feeling hot; Oedema	FLU3~SANOFI PASTEUR~U1501AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228282	10/27/2004	TX	4.0	4		F	10/19/2004	4 days after vaccines (10/15/04), fever 105, vomiting, tired.									Y	10/11/2004	10/15/2004	4	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Fatigue; Pyrexia; Vomiting	DTAP~SANOFI PASTEUR~C1996AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1440AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1040~4~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0315P~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0228283	10/27/2004	VA	13.0	12		M	10/20/2004	Pt received influenza vaccine and Td on 10/5/04. Returned to office on 10/11/04 with complaint of Knot on back of neck. First noticed knot on 10/8/04. Examination showed SC tender lymph node lt posterior lower neck, not hot, one cm, no enlarge nodes on remainder of neck, axilla, or groin.				Y					U	10/05/2004	10/08/2004	3	mono test negative, CBC, WBC 7,1k/dl, RBC 5.40 m/dl, HGB 13.8 g/dl, HCT 40.9%, MCV 76.0 Fl, MCH 25.6PG, MCHC 33.8 g/dl, RDW 12.8%, Platelet count 257, MPV 8.4, Polys 62.1%, Lymphocyte 34.4%, monocyte 3.5%.	PVT	PVT	NONE	NONE	NONE			1						1	Lymphadenopathy	FLU3~SANOFI PASTEUR~U1417AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~AVENTIS PASTEUR~U1279AA~6~IM~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0228284	10/27/2004	TN	71.0	71		F	10/19/2004	Localized erythema, pain left deltoid									Y	10/13/2004	10/16/2004	3		PVT	PVT		NONE	Nalfon= decrease B/P and edema; Percocet=rash.			1						1	Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U1450AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~MASS. PUB HLTH BIOL LAB~TD105~UNK~IM~LA~TD ADSORBED (TDVAX)~1	USA		Influenza
0228285	10/27/2004	CO	0.93	0	.9	M	10/22/2004	5PM has temp of 102. Gave baby Tylenol. At 2am had temp of 104.7. Called on call nurse told to give Tylenol and Ibuprofen at 3 hr intervals. Gave baby cool bath. Temp went down to 100.1. By 5AM temp was normal.									Y	10/16/2004	10/16/2004	0		PUB	OTH						1						1	Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0228289	10/27/2004	TX	61.0			F	10/26/2004	General malaise, dizziness									U					OTH	UNK						1						1	Dizziness; Malaise	FLU3~SANOFI PASTEUR~U1440AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228290	10/27/2004	KY	8.0	7		M	10/26/2004	Vaccine admin 3:30PM; 6PM began with flush, itching of scalp, neck, ear, red, warm. Slept good. Sat ok. Sun 10/2404 woke up 7AM 1/4 1/2 diam round, raised reddish (4) on arm of injection site left.  Soreness at site, called Dr, stop Anti, give Zertex, by PM rash gone.									Y	10/22/2004	10/22/2004	0	NONE	PUB	PUB	Advair inhaler	On Biacin 10/16/04, Bronchitis	Asthma, Allergy to mold, pollen, dust, feathers.			1						1	Erythema; Feeling hot; Flushing; Injection site erythema; Injection site pain; Injection site swelling; Pruritus; Erythema; Feeling hot; Flushing; Injection site pain; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U1394DA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1394AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0228291	10/27/2004	MA	50.0			F	10/26/2004	I broke out in hives, my arm was hot and swollen. I started itching uncontrollably. Saw a Dr in April 2001. I'm still itching and on Zyrtec. By appt finally April 2001.				Y					N					OTH	OTH	Zyrtec	NONE				1						1	Feeling hot; Oedema; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~V044388~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228292	10/27/2004	VA	0.82	0	.8	F	10/26/2004	Developed petechiae on arms and legs and cheeks on 10/14.				Y					Y	10/12/2004	10/14/2004	2	Normal platelets	PVT	PVT		NONE	NONE			1						1	Petechiae	FLU3~SANOFI PASTEUR~U1426M~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A79659A~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0228293	10/27/2004	GA	1.27	1	.3	F	10/26/2004	Fever, starring spell: vomited.				Y					Y	10/25/2004	10/25/2004	0	NONE	PVT	PUB		NONE	NONE			1						1	Pyrexia; Staring; Vomiting	DTAP~SMITHKLINE BEECHAM~21936A2~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1415AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0230P~4~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~495725~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0228295	10/27/2004	CO	19.0	19		U		Received influenza shot at 10:15 am then at 12:30 am (midnight) noticed acute onset of wheezing or shortness of breath and then developed bloody nose. Bedtime hot and flushed and light headed with continued wheezing and nasal congestion. Next day felt very fatigued. Asthma symptoms resolved on own.									Y	10/20/2004	10/21/2004	1	Spoke with allergist. She sees and he feels this was possibly R/T flu vaccine reaction.	OTH	PVT	BCP, Advair, Inhaler, Zyrtec D		Allergies, Asthma, History sinusitis			1						1	Condition aggravated; Dizziness; Dyspnoea; Epistaxis; Fatigue; Feeling hot; Flushing; Nasal congestion; Wheezing	FLU3~SANOFI PASTEUR~U1378AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228337	10/27/2004	MI	57.0	57		F	10/27/2004	Patient stated that approximately 40 minutes after vaccination she had an asthma attack. After a couple of hours she was better, but then awakened the next morning with blotches, not hives on her body.  She was working at the time of the asthma attack and did not report the incident until 24 hours later.									Y	10/18/2004	10/18/2004	0		UNK	UNK	Estrace, Prozac, Calan SR, Calcium	None	Allergies: Walnuts, Wool, dust, cats, mold.  History of asthma diagnosed 7yrs. ago, but no episode for 2 years. History of fibromyalgia.			1						1	Asthma; Condition aggravated; Rash macular	FLU3~SANOFI PASTEUR~U1499AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228339	10/27/2004	VA	57.0	57		F	10/27/2004	1 HOUR AFTER INFLUENZA IMMUNIZATION BECAME WEAK, DIZZY, HAD NAUSEA AND VOMITED.  COMPLAINED OF STOMACH PAIN CLAMMY AND WEAK. TAKEN TO ER - BECAME HYPOTENSIVE B/P FELL TO 80'S AND 50'S. 1 LITER NACL BOLUS - TENDELENBURG POSITION. Medical Records received on 2/2/2005 states pt experienced diarrhea.				Y					Y	10/21/2004	10/21/2004	0	NORMAL EKG	UNK	UNK	PROGESTIN, VITAMINS	NO	ALLERGIES TO KEFLEX - X RAY DYE. Medical Records received on 2/2/2005 states pylonephritis and UTI.			1						1	Abdominal pain upper; Asthenia; Cold sweat; Diarrhoea; Dizziness; Hypotension; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U1383AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228345	10/28/2004	MI	80.0	80		M	10/27/2004	80 year old nursing home resident, no acute illness. 10/18/04, dark, cloudy urine noted; UA ordered (10/24 lab report: numerous proteus mirabilis). On 10/22/04 at13:10 patient observed unresponsive and pale; no pulses, no respiration, no BP. CPR initiated, but unsuccessful. Note: Order written for 1cc flu vaccine; documented administration same, though facility says patient actually received 0.5cc. Nurse follow up on 11/01/04 states: UTI. Death Certificate received on 11/16/2004 states causes of death are hypertension and CVA.	Y	10/22/2004							N	10/14/2004			10/20/04: Urine analysis and culture positive for Proteus mirabilis.	PVT	PVT	Bumetanide; Celebrex; Docusate sodium; Flomax; Potassium CL; Meclizine; Prevacid		History of colon cancer; arthritis; vertigo; hypertension; benign prostatic; hypokalemia; diverticular disease; obesity.			1						1	Bacterial infection; Blood pressure decreased; Cerebrovascular accident; Chromaturia; Coma; Hypertension; Medication error; Pallor; Pulse absent; Urine analysis abnormal	FLU3~SANOFI PASTEUR~U1478AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0228346	10/28/2004	MI	76.0	75		M	10/27/2004	Flu vaccine given 10/14/04; unknown time (none charted). Flu vaccine 1cc with route not documented. 10/15/04 VS: 126/70, temp 97.7, 72, 20. No noted problems. 10/16/04 03:20, VS 140/50, 96.6, 64, 24; with time 97.3, 64, 24, 140/50. Complaints of feeling tired. 10/16/04 13:00 refused lunch (upset stomach); ate liquid diet. Skin W/D and pale. 14:25 while being assisted to bathroom, resident slumped. Nurse follow up on 11/01/04 states: bilateral cellulitis of legs. Death Certificate received on 11/16/2004 states cause of death is CHF and coronary artery disease.	Y	10/16/2004							N	10/14/2004	10/16/2004	2	10/12: CBC: WBC 17.4, RBC 2.85, Hgb 8.2, HCT 25.4, MCV 89, MCH 28.8, MCHC 32.3, Platelet count 310, Lymphocyte 8; Pro time 25.0, INR 2.1.	OTH	PVT	Humulin; Zomig; Ferrous sulfate; Lopressor; Lopid; Senokot; Microk; Metamucil; Lexapro; Cardizem; Bumex; Aranes; Protonix; Allopurinol; Nitro patch; Coumadin; Clindamycin; ASA; Glucophage; Oscal.	Resolving of cellulitis.	Diabetes Mellitus; Hypercholesterolemia; Hyperlipidemia; Anemia; Depression; Coronary artery disease; Atrial Fib; CHF; Lymph edema; Renal insufficiency; hematuria. Allergies to PCN and Ether.			1						1	Body temperature decreased; Cardiac failure; Cellulitis; Coronary artery disease; Dry skin; Fatigue; Laboratory test abnormal; Oral intake reduced; Pallor; Skin warm; Stomach discomfort	FLU3~SANOFI PASTEUR~U1478AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0228347	10/28/2004	MI	79.0	78		F	10/27/2004	Last physical 9/17/04. Nasal O2, alert. Last PRRS, S2, no murmur. 10/15 temporary episode of respiratory distress. 10/18 Fever 100.5; no coughing. 10/23 Fever 100.5, responsive, given O2; fever broke late morning. 10/24 Fever 102.2. 10/23 fever 102.4, rapid breathing; on O2, no respiratory distress. Died at 21:00. Death Certificate received on 11/16/2004 states cause of death is end-stage dementia. 11/2/04 Received medical records from PCP which revealed patient with multiple complex medical problems including late stage Alzheimers.	Y	10/25/2004	Y						N	10/14/2004	10/18/2004	4		OTH	PVT	Docusate Na; Miacalcin; Celebrex; Ostcal; Act Fears; Tylenol; O2 by nasal cannula.		Dementia; Agitation; Depression; Cancer. dysphagia			1						1	Dementia; Hypoxia; Pyrexia; Respiratory distress; Respiratory rate increased	FLU3~SANOFI PASTEUR~U1478AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0228348	10/28/2004	MI	70.0	69		M	10/27/2004	*Note: resident exhibiting cough 9/20/04. 10/7/04 choking and cough with food. 10/14/04 flu vaccine given. 10/20/04 worst cough and lung congestion. Blood oxygen 80-85% O2 at 26. 10/21/04 97.4, 60, 20, 150/80. Blood oxygen 92% with O2. 10/21/04 Hospice ordered. 10/22/04 99, 80, 28, 130/70; O2 saturation 90% with 3LO2. Unresponsive (1100). 10/23/04 0535 expired. Death Certificate received on 11/16/2004 states cause of death is COPD and end-stage dementia. 11/2/04 Nurses notes & med list from nursing home received.  Patient also had history of nicotine addition, dementia, emphysema and seizure disorder.	Y	10/23/2004							N	10/14/2004	10/23/2004	9	10/14/04 WBC 12.2, MCV 101, MCH 33.4, Neutrophils 26 (decreased), Lymphocytes 60 (increased); Mono 14 (increased). Smear suggestive of viral infection. (labs ordered 10/11/04).	OTH	PVT	Depakote; Dilantin; Aspirin; Colace; Lexapro; Multivitamin; Zantac; Vitamin B1; Megace; Oystcal; Nicotrol cartride inhaler; Tylenol; Morphine sulfate; Roxanol		Dementia; Nicotine addiction; Emphysema; Seizure disorder; Anxiety; Acute delirium; Bipolar disorder; No known allergies.			1						1	Choking; Coma; Convulsion; Cough; Dementia; Emphysema; Hypoxia; Laboratory test abnormal; Nasal congestion	FLU3~SANOFI PASTEUR~U1478AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0228356	10/28/2004	FL	81.0	81		M	10/21/2004	Information hsa been recieved from a registered nurse concerning an 81 year old male with high blood pressure, type II diabetes mellitus, hypothyroidism, chronic renal failure and osteoarthritis who on 10/12/04 was vaccinated in the left arm with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 647359/0740N). On 10/12/04, the patient was concomitantly vaccinated with a dose of influenza virus split virion 3v vaccine inactivated in the right arm. COncomitant therapy included terazosin hydrochloride, benazepril HCl, amlodipine besylate, iron, levothyroxoine Na, atorvastatin calcium, torsemide, warfarin sodium, allopurinol, acetaminophen (+) propoxyphen napsylate, pantoprazole sodium, folic acid, vitamin E, xanthophyll, epipen shots, and pyenogenol. Less than 24 hours later, on 10/13/04, the patient's left arm from his armpit to his elbow became red, hot, tender, and patchy/blotchy cellulitis like. The nurse confirmed that the reaction was not true cellulitis, and that all symptoms were considered injection site reactions. He also had chills and fever. Unspecified medical attention was sought. The patient was treated with an unspecified antibiotic and ice packs. It was reported that the patient's first vaccination was approximately 10 years ago. At the time of this report, the patient had not recovered. The nurse reported that the patient was scheduled for a follow up re-evaluation on 10/20/04. The patient's fever, chills, and injection site erythema, warmth, pain and blotchy/cellulitis like reaction, not cellulitis were considered other medical events (OMIC). Additional information has been requested.				Y					N	10/12/2004	10/13/2004	1	UNK	OTH	OTH	Darvocet; Allopurinol; Norvasc; Lipitor; Lotensin; Folic Acid; Iron; Levothyroxine sodium; Protonix; Terazosin hydrochloride; Demadex; Vitamin E; Coumadin; Xanthophyll		Blood pressure high; Type II Diabetes Mellitus; Hypothyroidism; Renal failure chronic; Osteoarthritis.		WAES0410USA02209	1						1	Chills; Injection site erythema; Injection site pain; Injection site warmth; Pyrexia; Rash macular	FLUX~UNKNOWN MANUFACTURER~U1489AA~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0740N~2~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0228359	10/28/2004	MI	77.0	76		F	10/27/2004	10/11/04 Prednisone started. 10/14/04 Flu vaccine administered. 10/25/04 Complaints of chest pain; left arm feels funny, diaphoretic. 96.8, 72, 20, 142/80, out today. 10/27/04 Remains hospitalized. Discharge Summary received on 1/25/2005 states pt experienced thrombocytopenia and myocardial infarction. Follow up 01/26/05: Patient still has not recovered, has had several transfers to hospital since October for heart condition. As per annual follow up report: pt continues to have atrial Fib which she had history of prior to flu vaccine but was not an issue again until after vaccine. Questionable if vaccine caused reoccurrance of atrial Fib.					Y	2			U	10/14/2004	10/25/2004	11	10/9/04 Platelet count 109 (decreased); MCH 26.9 (decreased); Neutrophil 97.3 (decreased); Lymphocytes 6.6 (decreased). 10/18/04 HCT 45.5 (increased); MCH 26.2 (decreased); Platelet 178 (WNL); 10/25/04 CBC: MCH 26 (decreased).	OTH	PVT	Danazol; Lasix; Norvasc; Microk; Ferrous sulfate; Prednisone; Prevacid; Prednisone;	Low platelet count	Myelodysplastic syndrome; Diverticulosis; Gastritis; CVA; HTN; GI bleed; Intracranial hemorrhage in right cerebellum; Cholecystectomy; Urinary incontinence; Anemia; OA; History of ITP; Vascular; CVA; Idiopathic thrombocytopenia.			1						1	Atrial fibrillation; Chest pain; Condition aggravated; Hyperhidrosis; Laboratory test abnormal; Myocardial infarction; Thrombocytopenia	FLU3~SANOFI PASTEUR~U1478AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0228360	10/28/2004	MI	81.0	80		M	10/27/2004	10/20/04 Sleepy; not as alert. 10/21/04 Arousable, no behavior issues; increased lethargy. 10/26/04 Lethargic; unable to grasp objects or feed self. Slight hand tremor visible. Oxygen started. Transferred to hospital for evaluation. Medical Record received on 2/02/2005 states UTI. Follow up 01/19/05: The patient has not recovered, he requires more assistance with activities of daily living, continues to have some confusion.					Y				U	10/14/2004	10/20/2004	6	CBC normal except low Hgb, HCT. Urine analysis: normal culture not indicated. Medical Record received on 2/02/2005 states WBC INC and positive staph culture.	UNK	UNK	Glipizide; Aspirin; Bumetanide; Detrol; Lexapro; Lipitor; Potassium Cl; Ranitidine; Travatan; Docusate; Lisinopril; Reminyl; Neurontin		Diabetes mellitus; Non-insulin diabetic; Dementia; Depression; Glaucoma; Cataracts; Conjunctivitis; Hypertension; Arteriosclerotic heart disease; Congestive heart failure; Other Cardiovascular disease; Bronchitis acute; Carotid artery disease; Cellulitis; Muscle degeneration; Obstructive sleep apnea; Obesity; Peripheral vascular disease; Peptic ulcer; Renal insufficiency. Medical Record received on 2/02/2005 states DM, dementia, CHF, CAD, cellulitis lower limbs, peripheral vacular disorder, obesity, sleep apnea, glaucoma, cataracts, renal insufficiency, and hypertension.			1						1	Bacterial infection; Laboratory test abnormal; Lethargy; Somnolence; Tremor; Urinary tract infection; White blood cell count increased	FLU3~SANOFI PASTEUR~U1478AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0228361	10/28/2004	MI	94.0	94		M	10/27/2004	10/19 Raled left lung; temp 97.4. 10/20 Mild congestive heart failure seen on x-ray, noisy breathing; started antibiotics. 10/21 Temp 99.5. 10/24 Temp 98.8. 10/25 Pale, rochi/crackles, decreased appetite, decreased voiding, slept all day. 10/26 Refused food, dehydration, water given, shallow breathing, O2 saturation 79%. Care refused by prior request. Medical Record received on 11/23/2004 states pt experienced rales and cough. Follow up 01/19/05, Recovery status unknown, patient expired in October.	Y		Y						N	10/14/2004	10/19/2004	5	Medical Record received on 11/23/2004 states O2 stats depressed.	OTH	PVT	Vitamin B12; Prevacid; Lasix; Bumex; Zithromax; Lumigan; Plavix; Synthroid; Terazosin	Hypothyroid; Incontinence; Depression	Hypothyroid; Chronic Pain; Depression; Partial Gastrectomy; Stroke			1						1	Anorexia; Cardiac failure congestive; Cough; Dehydration; Hyperventilation; Hypoventilation; Hypoxia; Oral intake reduced; Pyrexia; Rales; Somnolence	FLU3~SANOFI PASTEUR~U1478AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0228362	10/28/2004	MI	83.0	82		F	10/27/2004	2/26/04 Admitted to facility. 8/19 examined for possible atrial fib; results on EKG. 10/17 complained of chest pain, pulse 115-130; admitted to hospital. EKG showed atrial fib, rales (mild); Topol administered and stabilized. 10/20 Discharged. 10/24 Being given O2. 10/26 began moving self in wheelchair; no complaints.   Nurse follow up on 11/01/04 states: anemia; dementia; depression; constipation; mitral valve disease. Follow up 01/19/05: Patient has not recovered. Activity level did not recover, she continues to experience fatigue.			Y		Y	3			Y	10/14/2004	10/17/2004	3		OTH	PVT	Docusate; Namenda; Oscal; KCl; Duragesic patch; Albuterol inhaler; BUmex; Ferrous Sulfate; Aspirin; Isosorbide MN; Lexapro; Multivitamin; Norvasc; Protonix; Spironolactone; Lacri-luba.		Allergy to sulfa, asthma, COPD, Degenerative joint disease; GERD; CHF; Fractures			1						1	Anaemia; Atrial fibrillation; Chest pain; Constipation; Cor pulmonale; Dementia; Depression; Heart rate increased; Hypoxia	FLU3~SANOFI PASTEUR~U1478AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0228366	10/28/2004	WA	4.0	4		M	10/19/2004	Pt broke out in hives 30 minutes after receving immunizations. Pt was given Benadryl and was monitored in clinic.									Y	10/15/2004	10/15/2004	0		PVT	UNK		Asthma exacerbation	RAD, Obesity			1						1	Urticaria	DTAP~SMITHKLINE BEECHAM~C1612AA~5~~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1381AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1040~4~~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0960N~2~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0228367	10/28/2004	VA	77.0	76		F	10/21/2004	Muscle aches beginning evening 10/14. Next 2 days. Fever 102, malaise, all over aches, watery eyes, sneezing, deep cough, 3rd day symptoms continued without fever. 4th day felt better. 10/19 fever to 101 and aches resumed, not as bad as before. Today 10/21 feeling better but cough continues.									Y	10/14/2004	10/14/2004	0		PVT	PVT	Fosamax, Percocet prn, Ultracet prn, HCTz, Arthrotec	NONE	Osteoporosis, osteoarthritis, PVD			1						1	Cough; Lacrimation increased; Malaise; Myalgia; Pain; Pyrexia; Sneezing	FLU3~SANOFI PASTEUR~U1421AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0371P~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0228368	10/28/2004	MO	1.12	1	.1	M	10/27/2004	Bruising 2 days after vaccine. Treated at hospital.				Y	Y	1			Y	10/13/2004	10/14/2004	1	CBC; PTT; Platelet count 6000 then down to 0.	PVT	PVT	NONE	NONE	NONE			1						1	Contusion; Laboratory test abnormal; Thrombocytopenia	FLU3~SANOFI PASTEUR~U1462AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0228369	10/28/2004	MA	41.0	40		F	10/26/2004	Complaints of dizziness, weak, color pale. Feet elevated, severely diaphoretic. Passed out approximately 25 seconds. open eyes but glazed appearance and states feel like I'm dreaming. Resps even and slow. BP 126/84 prior to vaccination 114/68 post. Escorted to ER via wheelchair. BP 92/49. O2 sats 97-100. Pulse 62-66. BP further decreased to 86/49. IV fluids given in ER. BP increased 99/63 then to 118/77. Recurred and discharged at 12:00.				Y					Y	10/22/2004	10/22/2004	0	NONE	PVT	UNK		Recent ear infection	Allergy: Bactrim			1						1	Abnormal dreams; Asthenia; Dizziness; Hyperhidrosis; Hypotension; Pallor; Respiratory rate decreased; Staring; Syncope	FLU3~SANOFI PASTEUR~01445AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228370	10/28/2004	FL	45.0	44		F	10/27/2004	10/6/04: one hour after received vaccine. Had severe headache: increased severity during day. Felt light-headed. Nausea by evening. Chills. 10/7: severe headaches, malaise , poor appetite. 10/8: no headaches, symptoms resolved next 24 hours.									Y	10/06/2004	10/06/2004	0	NONE	PUB	UNK	Takes Vasotea, Diazide, Prevaria, Zyrtec,	NONE	Allergy: Penicillin, EES, Sulfa. Bees: Epinephrine,  Hypertension			1						1	Chills; Decreased appetite; Dizziness; Headache; Malaise; Nausea	FLU3~SANOFI PASTEUR~U1421AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228371	10/28/2004	FL	51.0	51		F	10/27/2004	10/5/04: severe dizziness started two hours after vaccine. Dizziness increases with charge eye movement. 10/6/04: Increased light headedness, slight tremors  both hands. Symptoms resolved next 24 hours.									Y	10/05/2004	10/05/2004	0	NONE	PUB	UNK		NONE	Allergies: Morphine, EES, Ampicillin			1						1	Dizziness; Tremor	FLU3~SANOFI PASTEUR~U1421AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228372	10/28/2004	FL	61.0	61		F	10/27/2004	10/7/04: Dizzy getting out of bed. Held onto wall to walk. Could walk very slowly. Less dizzy when eyes closed: 6 A. By 11:30 AM, some improvement : still dizzy. Walking slowly. Resolved in 24 hours.									Y	10/05/2004	10/07/2004	2	NONE	PUB	UNK	Hyzaar, Cardizam, Torporl	NONE	hypertension. Allergy: percocet/darvoret meds			1						1	Difficulty in walking; Dizziness	FLU3~SANOFI PASTEUR~U1421AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228373	10/28/2004	NC	6.0	5		M	10/26/2004	Received flu shot 10/18/04 on left arm. On 10/20 or 10/21 arm started breaking out red bumps: spread on neck and chest and arm. Complained of arm and neck hurting. Slight fever.									Y	10/18/2004	10/20/2004	2		PUB	UNK	Singulair	Asthma exacerbation	Biaxcin; Multiple food allergies. Most recent test negative for eggs per mom.			1						1	Erythema; Myalgia; Neck pain; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U1417AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228374	10/28/2004	NC	54.0	53		M	10/22/2004	Patient receive flu shot in right deltoid on 10/18/2004 at 2 pm. Patient reported no reaction at that time. Patient awoke on the morning of 10/20/04 with pain in right arm in the triceps , redness, swelling and tenderness. On exam, 45mm x 25mm area of redness, nickel-sized bruise at injection which was rather high for an IM injection in the deltoid, no palpable induration ,or warmth at site. Patient will take Tylenol every 4 to 6 hours for pain. Will follow up with health department if symptoms do not resolve.									Y	10/18/2004	10/20/2004	2	NONE	PUB	PUB	Avandia, Lisinopril,Zecor, Aspirin, Humalog	NONE	Diabetic			1						1	Contusion; Erythema; Pain; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U1496AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228375	10/28/2004	MN	64.0	63		M	10/25/2004	Pt complained of extreme swelling, redness, across entire upper thigh, difficulty walking , hot to the touch, occurred within 12 hours q dose administration. Resolved by 72 hours  He had similar episode 2 years ago.									Y	10/06/2004	10/06/2004	0	NONE	PVT	PVT	NONE	NONE	Asthma, no egg allergies			1						1	Difficulty in walking; Erythema; Feeling hot; Swelling	FLU3~SANOFI PASTEUR~U1380AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228376	10/28/2004	NC	73.0	73		F	10/22/2004	Lump left deltoid around 1 inch diameter, firm . Advised, assessed									Y	10/20/2004	10/20/2004	0	Pt to return 10/21/2004 for reassessment	PUB	UNK	BP Medicine	NONE	NONE			1						1	Injection site induration	FLU3~SANOFI PASTEUR~U1417AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228377	10/28/2004	MD	58.0	57		F		Chronic Right shoulder pain at injection site. It's been sent to ortho (x-ray)site.									N	11/17/2003	12/11/2003	24	No relevant tests	PVT	UNK						1						1	Injection site pain	FLU3~SANOFI PASTEUR~L765799~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228378	10/28/2004	IL	0.86	0	.9	M	10/22/2004	Here for check up, lungs clear. No hives. Within 5-7 minutes of administration of flu vaccine, pt skin erythemic with multiple hives face/neck and chest extending to entire body. By 20 min past injection, occ wheezing at ER: Epi 1/1000 0.1ml + Benadryl 2.5 cc po. Resolution of symptoms with treatment. Medical records state increased cough, allergic reaction. msv				Y					Y	10/13/2004	10/13/2004	0	Pulse ox 96%	PVT	PVT	NONE		Latex allergy + Pyloromyotomy for Pyloric Stenosis 12/03 Medical records state eczema. msv			1						1	Cough; Erythema; Hypersensitivity; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U1410BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228379	10/28/2004	OR	45.0	44		F	10/21/2004	Within 24 hours of receiving flu vaccine. Developed severe sore throat, elevated temp for 3.5 days hoarsness; severe back and hip/pelvic pain. Most symptoms continued for 1 week.				Y					Y	10/12/2004	10/13/2004	1		UNK	PVT		Diabetic Asthmatic				1						1	Back pain; Dysphonia; Pelvic pain; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U1504AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228398	10/28/2004	CA				U	10/27/2004	Young pregnant woman developed diminished vision bilaterally and headaches 3 wks post Fluzone injection. Reporter will file a complete report after he sees pt. Evaluation incomplete.				Y					U				Work up is in progress, reporter is a consultant	PVT	UNK						1						1	Headache; Unintended pregnancy; Visual acuity reduced	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228400	10/28/2004	WI	31.0	31		F	10/28/2004	Swelling, redness and warmth of skin surrounding site of injection (right deltoid).  Initially began as a firm lump Day 1, then spread outward from site of injection to include warmth, redness and firmness Day 2.  At time of reporting, surrounding redness, firmness of skin measures 10cm x 12cm (elliptical shape).  Also noted onset of discomfort (Day 1), then subsequent swelling and pain of right knee (Day 2).  No warmth or redness here.  Inability to bend knee back further than 90 degrees without significant pain Day 2.  Symptom onset and progression followed same course as the local reaction at site of vaccine administration.				Y					U	10/26/2004	10/27/2004	1		UNK	UNK		None	None			1						1	Arthralgia; Discomfort; Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth; Joint range of motion decreased	FLU3~SANOFI PASTEUR~U1460AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228401	10/28/2004	CA	1.22	1	.2	M	10/28/2004	My son developed a runny nose and nasal congestion a day and a half after receiving the flu vaccine.  He got the shot on Thursday, October 19th, symptoms began on October 21st, and he still currently has the runny nose and nasal congestion. The symptoms began six days ago through current.				Y					N	10/19/2004	10/21/2004	2	none.  We had a doctor visit on 10/27/04.	UNK	UNK	none	none	At six months old my son was diagnosed with IgG and IgA deficiency.  His specialist says that the IgG deficiency is transient so he will outgrow it and has never been started on immunoglobulin trasfusions.			1						1	Nasal congestion; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~~2~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0228402	10/28/2004	VA	5.0	4		M	10/28/2004	Redness and swelling on left arm below site of injection.  6cm x 6 1/2 cm area of erythema and firmness approx 4-5cm in diameter.									Y	10/13/2004	10/15/2004	2	none	UNK	UNK	none	none	none			1						1	Injection site erythema; Injection site induration; Injection site swelling	DTAP~SANOFI PASTEUR~c1996aa~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~u1427aa~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228404	10/28/2004	VA	2.0	2	.1	M	10/28/2004	Right Upper arm 5in x 4 in red ring around injection site.  None tender, mild bruising at injection site.									Y	10/18/2004	10/20/2004	2	none	UNK	UNK	Amoxicillin	recovering from URI	none			1						1	Contusion; Injection site erythema	FLU3~SANOFI PASTEUR~u1427aa~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228406	10/28/2004	OH	67.0	66		M	10/28/2004	Pt called to complain of swelling, warmth, and redness in left arm down to wrist and unable to bend arm.  Also has fever up to 104.0. Saw MD for symptoms. Was given steroids, antibiotics and a sling for his arm.  Taking Tylenol for fever.				Y					U	10/26/2004	10/26/2004	0	unknown	UNK	UNK	unknown	unknown	unknown			1						1	Erythema; Feeling hot; Oedema peripheral; Pyrexia	FLU3~SANOFI PASTEUR~U1517AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0062P~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0228413	10/28/2004	OR	43.0	42		F	10/28/2004	Received influenza vaccine 10/19/2004.  10/26/2006 1 diameter red raised skin with whelt in center.  10/28/2004 involved skin now 3 diameter red raised skin with multiple vessicles in the center.  Burning/itching sensation.  Sx not at the site of vaccine administration.  10/28/2004 primary MD seen.  Acyclovir 800mg 1 PO TID for shingles like reaction probably due to flu vaccine.				Y					U	10/19/2004	10/26/2004	7	culture taken of vesicles 10/28/2004.  Results pending.	UNK	UNK	Vitamins	None	None			1						1	Injection site vesicles; Pruritus; Rash erythematous; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0228231	10/29/2004	MD	50.0			F	10/26/2004	From initial information received on 10/22/04 from a physician regarding an adverse event occurring in the USA, it was reported that a 50 year old female patient received a dose of FLUZONE, lot number U1489AA, administered IM in the left deltoid on 10/8/04. Twelve days later, the patient died. The cause of death was not reported. A telephone call was placed to the reporter on 10/25/04 in order to obtain additional information. The physician reported that the patient was seen in the employee health department a few times in the past few months. She was seen on 8/16/04 with a complaint of not feeling herself. Her blood pressure at that time was 102/74. The patient was to follow up with her primary care physician. She was also seen on unspecified dates prior to vaccination with complaints of numbness in her legs, dizziness and lightheadedness. The physician also reported that the patient had complained to her co-workers approxiamtely one month ago that she was experiencing weakness and memory loss. As per the physician, there is very limited information for this case and the cause of death is unknown at this time. Additional information was received on 10/25/04 from the reporting physician. This case has been submitted to VAERS. The patient received the FLUZONE vaccination on 10/8/04 at 2:00 PM. Medical records and autopsy results were requested from the neurologist at the treating facility.  Follow up on 11/03/04 states: From additional information received on 10/26/04 from a neurologist, it was reported that an autopsy was performed on this pt, however the results and the cause of death are still pending. The pt's hospital records were provided. The pt was hospitalized from 10/12/04 till 10/20/04.  She was admitted with a preliminary diagnosis of possible transverse myelitis. Her chief complaint was lower extremity weakness. She presented with an acute onset of thigh pain and tightness, as well as foot weakness and numbness. The pt first noticed upon awakening discomfort in her legs, which worsened thoughout the day and she subsequently developed numbness, especially of her feet and weakness of her feet, as well as an inability to walk. At 10:00AM, on the day prior to admission, she was unable to void. She presented to the hospital, where a post-void residual was noted to be one liter and a Foley catheter was placed. The pt was taken for an MRI of her spinal cord and the reports were normal. She was transferred to another hospital for further workup, as she was unable to walk. Prior to this, the pt was otherwise healthy. Motor examination revealed normal tone. Strength was intact in the upper extremities. Dorsiflexion was noted to be one on the right and absent on the left. Plantar flexion was absent bilaterally and tone was decreased in the lower extremities. There was decreased sensation to pinprick and temperature in both lower extremities up to the anus, with a pin level approximately at S3. There was no dysmetria on finger-nose-finger testing. Rapid alternating movements were intact. Gait could not be tested as the pt was unable to walk. During the HEENT examination, it was noted that the fundi were poorly visualized due to pupillary constriction, however the vessels appeared normal. There were no carotid bruits. Pupils were two millimeters, but reaction. An MRI of the cervical spine showed no evidence of abnormal spinal cord signal suggestive of transverse myelitis.  There were mild disc bulges at C5-C6, T6-T7, L3-L4 and L5-S1 without any mass effect. Cervical, thoracic and lumbar MRI was performed, which did not show any evidence of cord impingement. An MRI of the brain with and without contrast was done and showed some mild to moderate periventricular white matter changes consistent with small vessel ischemic disease, as well as multpile lacunarinfarctions in the thalami, left caudate head, and periventricular white matter.  Although this was most likely secondary to lacunar strokes, these areas of focal restricted diffusion and increased T2-weighted signal could be secondary to encephalitis (autoimmune or infectious). No intracranial bleed, mass effect, midline shift or hydrocephalus was identified. As the pt did not have any improvement in her numbness or weakness, she was given a trial of Solu-Medrol pulse dose of one gram every day for three days. She did not have any side effects in the first 24 hours, but was noted to become severely agitated and developed visual and auditory hallucinations by the second and third day of treatment and this was stopped after 3 days. The pt was started on risperidone one milligram two times a day for her acute psychosis, and after the steroids were discontinued, her mental status was noted to clear slowly, although she had difficulty orienting to place and time. She was consistently oriented to herself.   On the morning of 10/20/04, approximately before 12:00 noon, the pt developed acute convulsion with head turning to the right, eye deviation to the right, and rigidity followed by chronic movements of the upper extremities. It was unclear if the pt had oculogyric crisis possibly due to risperidone, which had been stopped two days prior or whether she was having a seizure. She was certainly at risk for a seizure due to the lesions in her brain. The pt had a brief lucid interval after the first episode of head turning and convulsions, but then subsequently became unresponsive and therefore CPR was started and standard ACLs protocol was followed.  After approximately 15 minutes of resuscitative efforts, the pt was unable to be resuscitated. The time of death was approximately 12:17PM. The discharge diagnosis was noted to be multiple lacunar infarcts in the thalami, left caudate head and periventricular white matter, as well as transverse myelitis, hypertension and hyperlipidemia. The preliminary diagnosis from the autopsy preliminary report included mild thyromegaly, soft and autolysed spleen, uterine leiomyomata. The neuropathological examination was pending fixation.	Y	10/20/2004		Y	Y				N	10/08/2004	10/20/2004	12	Temperature on admission to the hospital was 97.4 degrees F, pulse 60, blood pressure 139/83, respirations 18 and pulse oximetry 99% on room air. Chemistries were within normal imits. CBC was also normal. Total cholesterol was elevated at 248, triglycerides 90, HDL 55 and LDL 175. CPK 112, TSH 1.98, B12 1268, CRP less than 0.5 and glycohemoglobin 6.1.  Liver function studies were normal with the exception of slightly elevated alkaline phosphatase of 192.  Erythrocyte sedimentation rate was 45. ANA was negative. C3 and C4 were within normal limits. Cryoglobulins were negative. FT nonreactive. HIV 1 and 2 ELISA nonreactive. Lyme antibody was negative. RPR was nonreactive. VDRL and the spinal fluid was nonreactive. CMV and HSV PCR were unreactive. Diagnostic studies on 10/12/04 included a cervical spine MRI at that was done without contrast, as the pt could not tolerate the contrast. The study showed no evidence of abnormal spinal cord signal suggesetive of transverse myelitis. There were mild disc bulges at C5-C6, T6-T7, L3-L4 and L5-S1 without any mass effect. Cervical, thoracic and lumbar MRI was performed, which did not show any evidence of cord impingement. A lumbar puncture was attempted at the bedside, but could not be obtained and therefore was done under fluoroscopy guidance. On 10/12/04 protein was elevated at 73, white blood cell count was 16 with lymphocyte predominance, glucose was 43, immunofixation was negative as were multiple CSF studies including cryptococcal antigen, VDRL, HSV, CMV, Lyme and TB PCR. An attempt to repeat the pt's lumbar puncture under fluoroscopy guidance was also done, however before the study could be obtained, it was felt that the pt should get an EMG and nerve conduction study to rule out other neuropathy or myopathy. The pt refused and stated that she was tired of obtaining studies and had no interest in any further examination. On 10/17/04, an MRI of the brain with and without contrast was done, which showed some mild to moderate periventricular white matter changes consistent with small vessel ischemic disease. Multiple lacunar infarctions were identified in the thalami, left caudate head and periventricular white matter. Although this was most likely secondary to lacunar strokes, these areas of focal restricted diffusion and increased T2-weighted signal could be secondary to encephalitis either (autoimmune or infectious). No intracranial bleed, mass effect, midline shift or hydrocephalus was identified. Lab data obtained 10/12/04 to 10/20/04 included: 10/12/04: Chemistry: phosphorus: 4.7 high; magnesium 1.4 low; SGPT (ALT) 77 high; ALK. Phos. 192 high; Vitamin B12, 1268 high; Glycohemoglobin 6.1 high; CBC: WBC 4.3 low; MCH 27.8 low; Coagulation protime: 12.8 L; INR: 0.9; PTT: 26L; Other hematology: sed rate: 45 high; Body fluid tests: CSF protein: 73 high; CSF RBC count: 10 [2] high; CSF WBC count: 16 [2] high; 10/13/04: Chemistry: phosphorus: 5.0 high; Magnesium: 1.4 low; CBC: MCH: 27.7 low; EOS %: 3.0 high; 10/14/04: Chemistry: Glucose 147 high; Phosphorus: 4.6 high; CBC: MCH: 27.5 low; Gran%: 82.8 high; Lymph %: 16.6 low; Lymph #: 1.1 low; Mono%: 1.5 low; EOS %: 0.1 low; 10/15/04: Chemistry: Glucose: 164 high; CBC: MCH: 27.7 low; Gran%: 84.7 high; Gran #: 6.2 high; Lymph%: 14.0 low; Mono%: 1.3 low; EOS %: 0.0 low; 10/16/04: Chemistry: chloride: 109 high; Glucose: 149 high; CBC: MCH: 27.9 low; Gran%: 87.1 high; Gran#: 9.6 high; Lymph %: 10.0 low; EOS%: 0.0 low; 10/17/04: Chemistry: chloride: 110 high; BUN: 27 high; CBC:MCH: 27.8 low; MCHC: 32.8 low; Manual differential: segs: 27 low; Lymphocytes: 61 high; RBC Morphology: abnormal; 10/19/04: Chemistry: BUN: 21 high; CBC: MCH: 27.7 low; MCHC: 32.9 low; 10/20/04: CBC: MCH: 27.5 low; MCHC: 32.9 low; RBC: 5.12 high;	OTH	PVT			The patient did not have any allergies to eggs or previous influenza vaccines. She was seen in the employee health department a few times in the past few months. She was seen on 8/16/04 with a complaint of not feeling herself. Her blood pressure at that time was 102/74. The patient was to follow up with her primary care physician. She was also seen on unspecified dates prior to vaccination with complaints of numbness in her legs, dizziness and lightheadedness. The physician also reported that the patient had complained to her co-workers approximately one month ago that she was experiencing weakness and memory loss.		200403444	1						2	Cardiac failure; Cerebral infarction; Circulatory collapse; Gait disturbance; Hyperlipidaemia; Hypertension; Lung disorder; Myasthenic syndrome; Myelitis transverse; Pain; Paraesthesia; Pulmonary oedema; Renal impairment; Blood pressure decreased; Laboratory test abnormal; Malaise	FLU3~SANOFI PASTEUR~U1489AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1489AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0228420	10/29/2004	TX				F	10/20/2004	Shaky, flushing, dry mouth, Benadryl 50mg IM x1.									Y	10/20/2004	10/20/2004	0	BP/HR every 15 minutes x3	OTH	OTH			Hypothyroidism			1						1	Dry mouth; Flushing; Tremor	FLU3~SANOFI PASTEUR~U1438AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228421	10/29/2004	NJ		41		F	10/19/2004	Redness, warmth, elevation 30mm appearing within 24 hours and disappearing 48 hours later.									Y	10/06/2004	10/07/2004	1	NONE	UNK	UNK						1						1	Feeling hot; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1501AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228422	10/29/2004	NJ		31		F	10/19/2004	Redness, warmth, elevation 30mm appearing within 24 hours and disappearing 48 hours later									Y	10/06/2004	10/07/2004	1		UNK	UNK		NONE	NONE			1						1	Erythema; Feeling hot; Injection site oedema	FLU3~SANOFI PASTEUR~U1501AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228423	10/29/2004	NV	49.0	48		F	10/25/2004	Pain, swelling, erythema									U	10/21/2004	10/22/2004	1		MIL	PVT	Placquenil, Atenolol, Synthroid, Voltaron, Allegra, Occurte, Vitamin E and C.	NONE	PMV, Hypothyroidism			1						1	Erythema; Oedema; Pain	FLU3~SANOFI PASTEUR~U1410BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228424	10/29/2004	TX	74.0	73		F	10/23/2004	Pain left arm, redness from vaccination area to elbow. Swelling left arm to elbow, itching lasted 4-5 days, arm was very hot. Follow up: problem at pneumococcal site only.									Y	10/05/2004	10/05/2004	0		OTH	PUB	Evista, Allegra, Bextra	NONE	Rhinitis			1						1	Feeling hot; Injection site erythema; Injection site oedema; Injection site pain; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~6987N~2~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0228425	10/29/2004	NJ	76.0	76		M	10/25/2004	Severe weakness, stiff neck , fast heart beat, chills, shoulder/arm connection pain, stiffness, can't raise arms, wrists pain, can't move in any direction, tickling sensation in center of back.									U	10/11/2004	10/14/2004	3	NONE	OTH	OTH	Aspirin 81mg, Toprol XL 12 1/2 mg	NONE	1997 Replaced aorta valve	~Influenza (Seasonal) (no brand name)~1~76.00~In Patient		1						1	Arthralgia; Asthenia; Chills; Heart rate increased; Hypokinesia; Musculoskeletal stiffness; Paraesthesia	FLU3~SANOFI PASTEUR~U11426AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228426	10/29/2004	NY	43.0	43		F	10/22/2004	Very Large oval red circle at exact area where flu vaccine was administered. Ask for size. Dr. Warm to touch, was sore only for a day. Not sore as of now.									Y	10/20/2004	10/20/2004	0		PVT	UNK			NONE			1						1	Feeling hot; Injection site erythema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0228427	10/29/2004	KY	75.0	74		F	10/25/2004	Pt developed bump in muscle immediately following shot. Pt reported no numbness or tingling and was able to move arm and fingers appropriately. A cold compress was applied immediately after shot and pt was monitored for signs of allergic reaction. Pt MD was notified and RPH will follow up with pt also.									Y	10/25/2004	10/25/2004	0		OTH	PVT	Lopressor, Lozol, Tricor, Glucovance	NONE	Diabetes, Hypertension			1						1	Injection site mass	FLU3~SANOFI PASTEUR~U1440AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228428	10/29/2004	VA		81		M	10/25/2004	Evening of shot developed red, sore, arm with lump size of orange. Was painful for 36 hrs. Did not take any meds, resolved on own. Also had Montezumas revenge first flu shot ever.									Y	10/07/2004	10/07/2004	0		OTH	PVT	NONE					1						1	Injection site erythema; Injection site mass; Injection site pain	FLU3~SANOFI PASTEUR~U1448AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228429	10/29/2004	NY	63.0	63		M	10/26/2004	Immediately shooting electrical pains in top right back of head x 7 days. Then dull aches continuing at time of report.				Y					N	10/06/2004	10/06/2004	0		PUB	PUB	Glucotrol, Plavix, Accupril, Zocor, Actos, Nexium	NONE	Diabetes Type II, HTN, High Cholesterol, GERD			1						1	Headache; Pain; Headache	FLU3~SANOFI PASTEUR~U140913A~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1409BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0228430	10/29/2004	IN	71.0	70		F	10/25/2004	Pt received influenza vaccine on 10/22/04. On Saturday she noticed several round red areas on stomach about the size of a quarter thinks she had a fever, was diaphoretic with Nausea. Her doctor's office told her to take Benadryl. She took 25 mg and feels better, but rash is still there.									U	10/22/2004	10/23/2004	1	NONE	PUB	PVT	Pt takes Nabumetone 750mg BID, Calcium 500mg BID, Fosamax 750mg 1 x 1wk	NONE	Allergic to Penicillin and Bee Stings			1						1	Erythema; Hyperhidrosis; Nausea; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U1503AA~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228431	10/29/2004	GA	76.0	75		F	10/22/2004	Pt says had chills, heart started racing and legs were weak.									U	10/18/2004	10/18/2004	0		OTH	PVT	UNK	UNK	UNK			1						1	Asthenia; Chills; Heart rate increased	FLU3~SANOFI PASTEUR~U1517AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228432	10/29/2004	WA	39.0	38		F	10/12/2004	Redness and swelling at site of injection, hoarseness, wheezing intermittent for 2-3 hours.									Y	10/11/2004	10/11/2004	0		OTH	PVT	Zoloft, Doxycycline	NONE	NONE	Redness, Swelling~Vaccine not specified (no brand name)~~7.00~In Patient	WA042065	1						1	Dysphonia; Injection site erythema; Injection site oedema; Wheezing	FLU3~SANOFI PASTEUR~U1448AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228433	10/29/2004	AZ	7.0	7		M	10/28/2004	Urticarial skin rash within 12 hours of flu vaccine.									U	10/27/2004	10/28/2004	1		PVT	PVT	Singulair, Serevent	NONE	Asthma, Allergic Rhinitis, Drug Allergy-Advair			1						1	Urticaria	FLU3~SANOFI PASTEUR~V145AAA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228434	10/29/2004	NY	36.0	35		M	10/25/2004	SOB, Cough, Rash (Diffuse erythema), Pruritis, Urticaria, Mild Tachycardia (122). NS 1,000 sec at wide open rate then 200 sec/hr. Solumedral 125mg IV, Discharge Meds: Prednisone 20mg twice each day for 4 days, Benadryl 50mg ever 6 hr today then if needed. Final diagnosis: allergic reaction to Flu vaccine.				Y					Y	10/18/2004	10/18/2004	0	O2 sat 97	PUB	PVT			GERD			1						1	Cough; Dyspnoea; Pruritus; Rash erythematous; Tachycardia; Urticaria	FLU3~SANOFI PASTEUR~U1425AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228435	10/29/2004	AZ	70.0	69		F	10/28/2004	Left upper red and swollen within 30 minutes of injection. Minor redness at site remains 10/28/04. No medical treatment administered.									Y	10/22/2004	10/22/2004	0		OTH	PVT	NONE	NONE	Allergic to many medications and preservatives in foods			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1411AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228436	10/29/2004	AZ				F	10/18/2004	Rash on inside of both arms from wrist to armpit. Small raised pimples. Right side of arm red and swollen. All rashes gone on 10/21/04.									U	10/16/2004	10/17/2004	1		OTH	UNK	Fosomax 10mg, 1 tab a week.	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Rash maculo-papular	FLU3~SANOFI PASTEUR~U1411AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228460	10/29/2004	IA	6.0	6		M	10/29/2004	Patient vomited twice on 10/14/04 at 3am and 5am starting 9 hrs after receiving the Flumist vaccine. Patient had no previous symptoms and no one in family did. Patient on 10/29/04 tested positive for strep throat.									Y	10/13/2004	10/14/2004	1		UNK	UNK	none	none	none			1						1	Bacterial infection; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500335P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0228461	10/29/2004	CA	29.0	29		M	10/29/2004	LARGE AREA OF ERYTHEMA (>120 MM) W/ SWELLING AND PAIN EXTENDING FROM L. SHOULDER TO L. ELBOW.									Y	10/26/2004	10/28/2004	2		MIL	MIL	MOBIC HYDROXY CUT (EPHEDRA FREE) CREATINE-PHOSPHOGEN HP (5 MG) MULTI-VIT	NONE	S/P ORIF r. ankle June 02			1						1	Erythema; Oedema peripheral	ANTH~EMERGENT BIOSOLUTIONS~FAV092~4~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1501AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228463	10/29/2004	WA	47.0	47		F	10/29/2004	Flu vaccine given 10-27-2004.  Started feeling itchy morning of 10-28-2004 and as the day progressed she became worse.  As of 10-29-2004 she presents to the clinic with urticarial rash scattered over entire body, has been taking Benadryl since 7pm on 10-28-2004.  Woke up on 10-29-2004 at 0130 with numbness and inflammation on lower lip.  She has been taking soda baths to relieve the itching.  Her lower lip is quite edematous and red.    Benadryl 50mg every 6 hours - was ordered by provider.  Patient instructed to call ER if symptoms worsen or persist.									Y	10/27/2004	10/28/2004	1		UNK	UNK						1						1	Erythema; Face oedema; Hypoaesthesia; Injection site inflammation; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1451AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228464	10/29/2004	MO	3.0	2	1	F	10/29/2004	Woke up with a rash(hives) on her stomach.  Within hours in had spread to her entire body.  This caused severe itching and irratibility.				Y					U	10/27/2004	10/28/2004	1	-Dr. check-up.  Dr. reported most likesly caused from flu shot. Severe hives. Gave her Zyrtec and Benedryl.  He stated that the hives could last 3 days to 2 weeks.	UNK	UNK	Albuterol Mytussin	persistant cough( 2 1/2 weeks)	allergies(receives allergy injection)			1						1	Irritability; Pruritus; Urticaria	FLU3~PFIZER\WYETH~~1~ID~LL~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0228467	10/29/2004	TX	69.0	68		F	10/29/2004	Patient notified immunization clinic on 10/11/04 that immediately after receiving flu shot on 10/7/04 she felt pain radiating down her right arm to her elbow. She did not complain to immunization staff at that time. She has since seen a family practice physician on 10/08/04 and an orthopedic surgeon on 10/25/04, who administered a cortisone injection into her right arm to relieve the discomfort.				Y					N	10/07/2004	10/07/2004	0		UNK	UNK	none given	none given	none given			1						1	Pain	FLU3~SANOFI PASTEUR~U1418AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228469	10/29/2004	TX	29.0	28		F	10/29/2004	Wheezing, Hoarseness, Fast Heartbeat, Difficulty Breathing									Y	10/25/2004				UNK	UNK	Paxil, Wellbutrin, Adoxa, BC Pill	None	Exercise-induced asthma			1						1	Dysphonia; Dyspnoea; Heart rate increased; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0228470	10/30/2004	FL	7.0	7		M	10/30/2004	3 days after Flu-Mist developed urticaria.  The wheals spread and coalesced and had the appearance of erythema multiforme by the next day. Low grade fever, 99.1 with mild cough and rhinorrhea noted.  Otherwise, child acting and playing normally.									U	10/26/2004	10/29/2004	3		UNK	UNK		rhinorrhea only	allergic rhinitis			1						1	Cough; Erythema multiforme; Pyrexia; Rhinorrhoea; Urticaria; Pruritus; Rash erythematous	FLUN3~MEDIMMUNE VACCINES, INC.~500336P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500336P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0228472	10/31/2004	CA	64.0	64		F	10/31/2004	After receiving the flu shot at 2 pm on Oct. 26, I woke the next morning with lower back pain from muscle spasms, slight fever (1 degre), and very low energy.   I find this significant only because my brother had the same symptoms 2 weeks earlier, especially the back spasms.  He was in such pain that he went to a chiropractor for an adjustment.									Y	10/26/2004	10/27/2004	1		UNK	UNK			pollens, molds, wheat, milk, cruciform vegetables, chemical sensitivities especially to petroleum products			1						1	Asthenia; Back pain; Muscle spasms; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0228473	10/31/2004	NY	76.0	76		F	10/31/2004	Soreness in upper left arm, tingling, shooting pain beginning same day and continuing until present time.  Bruising at upper shoulder which was the site of the shot. Medical Record received on 1/25/2005 states glucose elevation and ischemia.				Y	Y	2			N	10/03/2004	10/03/2004	0	Stress test, x-rays, blood work, lung scan	UNK	UNK	Coumedin, Glucotrol, Ditropan, Altace, Zettia	none	Diabetes type 2, penicillin allergy, adhesive tape allergy, high blood pressure, high cholesterol, HX of blood clots			1						1	Contusion; Hyperglycaemia; Myocardial ischaemia; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U1498AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0228475	10/31/2004	NY	42.0	42		F	10/31/2004	hives through out trunk, face , neck , arms. Slight s.o.b. only. (R) ear ache , sore throat,flushed . OBset abouyt 20 min. per shot . Benadryl 50 mg. po through out day for recurring hives. Shortness of breath only at 1st. hour. no treatment for breathing needed. ( I anaphylact for bee stings, so can differenciate. have at this point had recurrence of hives through out  last 20 hours.									Y	10/31/2004	10/31/2004	0	none	UNK	UNK	I take allergy shots every other week . last shot 2 days prior in left arm		Bee sting allergy			1						1	Dyspnoea; Ear pain; Flushing; Pharyngolaryngeal pain; Urticaria	FLUX~UNKNOWN MANUFACTURER~u1498aa~1~SC~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0228476	10/31/2004	NY	58.0	57		F	10/31/2004	Was vacinnated at 13:15 hrs. and stayed at the flu clinic for 20 mins. drove home and about 15:45 hrs.- my arm at the injection site was itching me but I did not scratch it!  I noticed on my left hand; inject. was on my left arm- 2-3 large hives appeared and I wouldn't scratch them. Put Caladryl on my hand(lft.) took 2 Benadryl tabs and went to bed.  Later that evening- the itching stopped and the hives went away.									Y	10/30/2004	10/30/2004	0		UNK	UNK			Asthma.  I've had flu shots every yr. for 24 yrs. and this was the first time I've ever had a reaction to it.			1						1	Injection site hypersensitivity; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1377AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228490	11/01/2004	NY	6.0	6		F	10/29/2004	Child had developed hives within few minutes after administering the vaccine.									Y	10/13/2004	10/13/2004	0	NONE	PVT	OTH	NONE	Cold	Asthma			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1411AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228491	11/01/2004	VA	47.0	47		M	10/21/2004	Pt states he took 2 doses. He experienced headache, fatigue, light-headedness and prickly feeling all over. He noted redness on his back. No rash or shortness of breath.									U	10/25/2004	10/27/2004	2		PVT	PVT	Amitryptylin	NONE	history of depression			1						1	Dizziness; Erythema; Fatigue; Headache; Sensory disturbance	FLU3~SANOFI PASTEUR~U419AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~BERNA BIOTECH, LTD.~3000416~1~PO~MO~TYPHOID LIVE ORAL TY21A (VIVOTIF)~1	USA		Influenza
0228492	11/01/2004	PA	1.35	1	.3	M	10/22/2004	Fever 103. 10/19/2004. Lethargic				Y					Y	10/18/2004	10/19/2004	1	CBC normal	PVT	PVT	Cefzil	Otitis Media				1						1	Lethargy; Pyrexia	FLU3~SANOFI PASTEUR~U1489AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228493	11/01/2004	ME	58.0	57		F	10/25/2004	Fever joint pain, malaise, rash									U	10/19/2004	10/19/2004	0	NONE	PVT	PVT	Diclofenac 75 mg BID, Zoloft, Wellbutrin	NONE				1						1	Arthralgia; Malaise; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U1457AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228494	11/01/2004	CA	5.0	4		U		Erythema, warmth and swelling of left proximal arm deltoid region extending toward elbow. Has flu appointment.									U	10/21/2004	10/22/2004	1	NONE	PVT	UNK		NONE				1						1	Erythema; Feeling hot; Swelling	FLU3~SANOFI PASTEUR~U1452AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228495	11/01/2004	NC	51.0	51		F	10/26/2004	Pt had a blister appear where immunization given.									Y	10/21/2004	10/22/2004	1		PUB	PUB	Allegra, Clonazepam, Neurontin, Aclonol, Zovor, Zolost, Viovan, Lidocaine, Xanax, Lorta, Norco, Albuterol Inhaler, Nasarol, Caltrate, Centrium Silver, Vitamin E	NONE	Asthma, Osteoarthritis, RSD			1						1	Injection site vesicles	FLU3~SANOFI PASTEUR~U1501AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228496	11/01/2004	OH	72.0	72		F	10/25/2004	Patient came into pharmacy on October 25th and complained that her arm hurt after receiving flu shot October 4th. Complained of arm pain that radiated to both shoulders. No medical attention received. Patient commented it was hard to turnover in bed. Patient says it still slightly hurts across her shoulders.									Y	10/04/2004	10/04/2004	0		OTH	OTH						1						1	Hypokinesia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0228497	11/01/2004	WA	76.0	75		F	10/22/2004	Flu shot 0.5cc given 10/19/2004. Pt noted mild redness, slight swelling , warm feeling around injection site by 10/21/2004.									U	10/19/2004	10/21/2004	2		UNK	UNK	Clonazepam, Synthroid					1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U1440AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228498	11/01/2004	CA	3.0	3		F	10/21/2004	About 4-6 hours after vaccination, left deltoid began swelling. Spread to mid left clavicle skin and just past left elbow skin, over 2 days. Began receding on Augmentin, Zyrtec, Motrin. Recovered over a few days.				Y					Y	10/18/2004	10/18/2004	0		PVT	PVT	NONE	NONE	NONE			1						1	Swelling	FLU3~SANOFI PASTEUR~U1449AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228499	11/01/2004	KS	79.0	78		F	10/15/2004	Couldn't move arm, sick to stomach, nausea, chills, felt faint, pain in left arm, left shoulder, left neck. Thinks fever 24 hours later, woke up soaking wet.				Y					U	10/15/2004	10/15/2004	0		PVT	UNK	Lipitor, BP med, started on Clarinex and Ibuprofen for reaction	NONE	COPD/ Asthma, Osteoporosis, Environmental allergies			1						1	Abdominal pain upper; Chills; Dizziness; Hyperhidrosis; Hypokinesia; Nausea; Neck pain; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1417AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0987N~3~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0228500	11/01/2004	WA	78.0	77		M	10/25/2004	Received vaccine 10/7/04: on 10/14 : my right arm from deltoid to elbow was swollen and discolored. Wife received shot on 10/14 and told the nurse about my swollen arm and discoloration on my deltoid became enlarged and swollen. Nurse told to go to ER. Also elbow to wrist was swollen.				Y					Y	10/07/2004	10/14/2004	7		UNK	UNK						1						1	Skin discolouration; Swelling	FLU3~SANOFI PASTEUR~U1426AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228501	11/01/2004	AZ	41.0	40		F	10/22/2004	Serious upper respiratory infection, still sick 2 weeks later. Was placed on decongestion then antibiotics. Doctor said it was from the flu vaccine. 101 F temp for days, nasal discharge severe, now to cough and asthma symptoms.									N	10/08/2004	10/09/2004	1	Chest x rays, sinus x rays	UNK	PVT	Lo-ogestrel	NONE	Asthma			1						1	Asthma; Condition aggravated; Cough; Pyrexia; Rhinorrhoea; Upper respiratory tract congestion	FLU3~SANOFI PASTEUR~11426a~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228502	11/01/2004	WI	77.0	76		F	10/25/2004	10/21/04: Pt reports: began to feel ill, 10/22 by 10PM 101.5 degrees. By midnight 102 T, became diaphoretic, had to change sheets and night gown, 10/23 low grade fever, Tachycardia, right leg was restless, right arm itching but had sot in left arm 10/24 entire body shaking, hoarseness present, low grade temp. 10/25 better 10/26 temp normal. No further problems. She call her doctor on 10/22. He told her he was not fine. had these symptoms did not suggest she see him.									Y	10/21/2004	10/21/2004	0	NONE	PUB	PUB	Tylenol, Vasotec, Lopresor, Multivitamin, Vitamin C,E,B12	NONE				1						1	Dysphonia; Hyperhidrosis; Pruritus; Pyrexia; Restless legs syndrome; Tachycardia; Tremor	FLU3~SANOFI PASTEUR~U1479AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228503	11/01/2004	OH	57.0	57		F	10/20/2004	After receiving flu vaccine (Aventis) shortly after, nose, mouth, cheek, became red, itching: after work, arm was very red, swollen 2x2 : also had angio edema to right side of face. Had had flu vaccine in past  6 years.									Y	10/04/2004	10/04/2004	0		PUB	PVT	Synthroid, Lopressor, MIA/ Cokin, Nose Spray, Zecor, Gypro	NONE	PCN allergy, Codeine, Cipro: Mitral Valve Prolapse, High cholesterol, degenerative disk, Hypothyroid			1						1	Erythema; Face oedema; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U1409BA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228504	11/01/2004	NY	0.5	0	.5	F	10/26/2004	Pt was found dead in her crib on the morning of 19OCT2004 Follow up: congestion of the lungs, liver and brain. Pending investigation and toxicology examination. Follow up: Coroner states that father of baby mentioned the bay was slightly more fidgety than usual the evening before this death.  - Review of well-baby progress note on 11/8/04 indicates baby was apparently healthy at time of immunizations. No additional symptoms.  - - 03/23/2005 autopsy report rec'd.  COD was SIDS.	Y	10/19/2004							N	10/18/2004	10/19/2004	1	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Irritability; Liver disorder; Nasal congestion; Nervous system disorder; Pulmonary congestion; Sudden infant death syndrome; Unevaluable event	DTAP~SMITHKLINE BEECHAM~622A2~3~~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1407AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1038~3~~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~A74404~3~~RL~PNEUMO (PREVNAR)~1	USA	Results in Death	Influenza
0228567	11/01/2004	PA	57.0	57		F	11/01/2004	Started itching all over my body shortly after the shot was given.  I kept itching worse and worse until I itched from my head to the soles of my feet badly. Also my chest hurt inside.  Slightly hard to breathe.  Took Allergra and then called my doctor (talked on the phones, it was Saturday morning) for a prescription for Prednisone.  In addition to ADvair which I take daily, I used a nebulizer to help the breathing situation.									Y	10/29/2004	10/29/2004	0	Still itching on Monday, taking Prednisone, and chest still hurts.  Also, have seasonal allergy problems in general but felt OK before the flu shot.	UNK	UNK	Advair, Diovan HCT, Xanax, Tylenol	None	Asthma, Allergies, plate with 8 screws in neck (spinal fusion), nerve damage from neck injury, radiculopathy, arthritis.			1						1	Chest pain; Dyspnoea; Hypersensitivity; Pruritus	FLU3~SANOFI PASTEUR~U1439AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228570	11/01/2004	IN	39.0	39		F	11/01/2004	Pt. had hives mostly on chest one hour after given flu vaccine.  Referred to ER and given Benadryl for hives.				Y					Y	10/28/2004	10/28/2004	0	None	MIL	PVT	NONE	None	Allergies: PCN, ASA, CEPHALOSPORINS, CODEINE, CODONE, CLARITIN.			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1454AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228576	11/01/2004		24.0	24		M	11/01/2004	Red erythamatous itchy rash to arms, torso and legs began approx. 4 hours after vaccination. Patient presented to medical after 2 hours. Pt. showed no signs of acute distress, no difficulty breathing, non toxic. Patient was treated w/150 mg. Benadryl IM and 100 mg prednisone by mouth immediately and was monitored for 30 minutes, until symptoms resolved, then was prescribed Prednisone taper times 6 days, Zantac 150 mg by mouth 2X per day and Benadryl 25 mg. by mouth every 6 hours.  Patient was instructed to return if symptoms persisted, rebounded, or worsened and to f/u in 1 day.				Y					Y	11/01/2004	11/01/2004	0		MIL	MIL			allergy to bee stings			1						1	Erythema; Pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~U1454AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228577	11/01/2004	OH	67.0	66		F	11/01/2004	Patient called states she has had extreme fatigue since shot 5 days ago.  She also gets nauseated everytime she tries to do any activity.  Also gets clammy and chills and has to sit down often.									U	10/27/2004	10/28/2004	1	None	UNK	UNK	Avapro; Aciphex; Hydochlorothiazide; K-Dur; Diclosenac (started day before shot); Multivitamins; Vit C & E;	None	arthritis; Hypertension;			1						1	Chills; Cold sweat; Fatigue; Nausea	FLU3~SANOFI PASTEUR~U1383AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228580	11/01/2004	CA	39.0	38		F	11/01/2004	severe nasal congestion that lasted for a week and a half to two weeks; took Sudafed cough and cold capsules, tylenol extra strength, Robitussin CF. mild but noticeable headache									Y	10/15/2004	10/17/2004	2		UNK	UNK		possible exposure to cough and cold				1						1	Headache; Nasal congestion	FLUN3~MEDIMMUNE VACCINES, INC.~500335P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0228581	11/01/2004	MN	69.0	68		F	11/01/2004	Pt. returned to walk-in clinic about 20 minutes after receiving Fluzone. C/O Itching on chest and upper back.  Area was reddened.  No hives or raised lesions were noted.  Denied difficulty breathing.  Called MD Consultant.  She ordered Benadryl 25-50mg.  Pt. instructed to take benadryl as soon as possible when returning home and to call personal physician if symptoms worsen.  I called the pt the next morning to see how she was.  She stated that the symptoms were gone about 30 minutes after taking the Benadryl.									Y	10/27/2004	10/27/2004	0		UNK	UNK		Denied	Denied			1						1	Injection site erythema; Pruritus	FLU3~SANOFI PASTEUR~U1476AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228582	11/01/2004	AZ	47.0	46		F	11/01/2004	Within 8 hrs of receiving Influenza vaccine developed severe headache, by next morning malaise and body aches, within 24 hours fever 103.  Resolved within 72 hours									Y	09/25/2004	09/25/2004	0		UNK	UNK	none	none	none Had exactly the same response to 1st influenza vaccine about 6 years ago; has not received it since due to concerns about reaction, until last week	Very similar symptoms~Influenza (Seasonal) (no brand name)~1~0.00~In Patient		1						1	Headache; Malaise; Pain; Pyrexia; Similar reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~U1381AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0227792	11/02/2004	CO	70.0			F	10/29/2004	From initial information received on 10/26/04 from another manufacturer (WAES0410USA00063) regarding an adverse event occurring in the USA, which was originally reported by a health care worker it was reported that a 70 year old female patient received a PNEUMOVAX 23 vaccination, lot number 647359/0740N administered IM in an unspecified site and a FLUZONE, lot number, route and site not specified, administered on 9/28/04. Reportedly the next day the patient developed lymph node swelling and fever. The patient was seen in the emergency room. It was also noted that the patient was hospitalized. The patient's recovery status is listed as not recovered. The reporter of this event expressed a concern with the PNEUMOVAX 23 lot number 0740N. The reporter also mentioned four other female patient's (WAES0410USA00906; 0410USA00907; 0410USA00908, and 0410USA00909) who were also vaccinated with a dose of PNEUMOVAX 23 and developed similar reactions. No product quality complaint was involved. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Lymph node swelling and fever were considered to be immediately life-threatening and disabling. The reporter of this case is the same reporter of cases 200403407,  2004034408, 200403409, and 200403410.From additional information received on 15NOV2004 from a health care professional, it was reported that there are no adverse events to report. In additiion, the reporter's telephone number initially reported by another manufacturer is not the correct number. A new telephone number was provided.  From additional information receive from a telephone communication from the initial reporter on 17NOV2004, it was reported that the reaction was due to administering both vaccines in the same arm that was an error on their part. All of these patients have recovered. No additional information is anticipated, thiscase is considered closed.			Y	Y	Y		Y	Y	N	09/28/2004	09/29/2004	1	UNK	OTH	OTH			It is unknown if the patient has any pre-existing physician diagnosed allergies, birth defects or medical conditions. It is unknown if the patient was taking any other medications at the time of vaccination.		200403473	1						2	Lymphadenopathy; Pyrexia; Lymphadenopathy; Medication error; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0740N~UNK~IM~~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0740N~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0228590	11/02/2004	CT	2.0	2	.4	M	10/29/2004	From initial information received on 10/21/04 from a health care professional regarding an adverse event occurring, it was reported that a two year old male patient received FLUZONE, lot number U1442AA, administered IM on 10/19/04. The site of administration was not reported. One day later, on 10/20/04, the patient experienced tonic-clonic seizures that began focally in his foot and progressed to his entire body. He was afebrile with a temperature of 97.1 degrees F. The patient was admitted to the hospital. His past medical history is significant for premature birth at 28 weeks gestation, cerebral palsy, hydrocephalus, developmental delays and infantile spasms. He has a ventriculo-peritoneal shunt and has a triplet sibling who had an intraventricular hemorrhage. He was started on Dilantin and was scheduled to follow up with a neurologist. The seizure activity ceased after the patient was placed on Dilantin, but he is still being treated. The patient has not recovered from these events.					Y	1			N	10/19/2004	10/20/2004	1		UNK	UNK			The patient was born prematurely at 28 weeks gestation and has a history of cerebral palsy, hydrocephalus, developmental delays and infantile spasms. He has a ventriculo-peritoneal shunt and has a triplet sibling who had an intraventricular hemorrhage. The patient is not on any medications and did not have any illnesses at the time of vaccination. He had an influenza vaccine last year, but it was not reported whether he experienced any adverse events.		200403435	1						1	Convulsion	FLU3~SANOFI PASTEUR~U1442AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0228592	11/02/2004	WV	54.0			F	10/29/2004	From initial information received from a physician on 10/26/04 regarding an adverse event occurring, it was reported that a 54 year old female patient received her first dose of FLUZONE, lot number U1138AA, administered in an unspecified site on 10/29/03. Reportedly seven days later the patient was admitted to the hospital with complaint of bilateral lower extremity numbness and weakness. She was diagnosed with Guillain Barre Syndrome. The patient's recovery status is listed as not recovered as she remains wheelchair bound.					Y				N	10/29/2003	11/05/2003	7		UNK	UNK	Coumadin; Indapamide; Metoprolol; Digoxin		The patient denies any illnesses at the time of vaccination. The patient has no known drug allergies, however does have a past medical history of heart disease and spinal stenosis.		200403476	1						1	Guillain-Barre syndrome; Hypoaesthesia; Muscular weakness	FLU3~SANOFI PASTEUR~U1138AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0228601	11/02/2004	IL	1.81	1	.8	F	11/01/2004	11/01/2004: mother called in to report that the next morning after she received her immunization. Her right leg where injection was given was swollen. Approximately 4 red and hot for three days. Mom also states she had a rash bumps over face, chest and back.									U	10/21/2004	10/22/2004	1		PUB	PUB		NONE	NONE			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Rash	DTAP~SANOFI PASTEUR~C1680AA~3~~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1416AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0314P~1~~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0228602	11/02/2004	FL	79.0	79		F	11/01/2004	Patient experienced hives all over her body, even soles of her feet; tongue swelled, even hives on tongue became worse, went to hospital ER at 6:30 AM 10/30/04 and was treated.				Y					Y	10/29/2004	10/30/2004	1		PUB	UNK	Metroprol, Lipitor, Multivitamins		Irregular heart beat: 2.03			1						1	Tongue oedema; Urticaria	FLU3~SANOFI PASTEUR~U1479AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228603	11/02/2004	MI	40.0	40		M	11/01/2004	Patient developed cellulitis of right upper extremity.									U	10/29/2004				PUB	UNK	Singulair, Albuterol, Advair, Zyrtec	Asthma				1						1	Cellulitis	FLU3~SANOFI PASTEUR~U1462AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0062P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0228604	11/02/2004	WI	1.72	1	.7	M		Screaming, irritability and holding abdomen as if in pain, from approximately 2 hours after immunization until two days later. Medical Records received on 1/12/2005 state gastroenteritis.									Y	10/29/2004	10/29/2004	0		PVT	PVT	Robitussin for cough and cold	URI symptoms	NONE			1						1	Abdominal pain; Gastroenteritis; Irritability; Screaming	FLU3~SANOFI PASTEUR~U1500AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228605	11/02/2004	NM	10.0	10		M	10/29/2004	+ Bilateral swelling and erythema of both eyes 2 hours after receiving the influenza vaccine. Patient given Epinephrine 0.3 mg SQ with significant improvement. Prescribed Benadryl 25mg q 6 hours x48 hours.									Y	10/29/2004	10/29/2004	0		PVT	UNK		NONE	Insulin dependent diabetes mellitus			1						1	Erythema; Eye disorder; Eye swelling	FLU3~SANOFI PASTEUR~U1512AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228606	11/02/2004	CA	69.0	68		F	11/01/2004	Pneumonia Vax was given up in shoulder bone, it caused dark bruising.  5 hours later unable to move because of pain, kind of paralyzed. Doctor advised to take Advil/ Ibuprofen and put heat. Today there is still bruising and pain at site but have movement.				Y					N	10/28/2004	10/28/2004	0		UNK	PUB	Lithium, High Blood pressure pill	NONE	High blood pressure			1						1	Contusion; Hypokinesia; Injection site pain; Joint range of motion decreased; Pain; Skin discolouration	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0228607	11/02/2004	WV	69.0	69		M	10/25/2004	Client received Fluzone flu shot IMLD on 10/19/2004 at 8:20pm. Client phoned me on Saturday 10/23/04 and advised me of the following: on Thursday 10/21/04 around noon he noticed rash to arms, legs and groin area, worse to groin. Itchy. Rash began as scattered , pink, non-raised to slightly raised, then developed a dark red dot in centers and elevated more and spread, with blotches connecting. Rash became dark red/ purplish. He was without wheezing or breathing difficulties. He did have some occasional dizziness without passing out. Positive for malaise. He is up and moving about with periods of rest. He states that he feels like he had been running a fever, temperature not taken. Denies any new foods, medicines, detergents or sea food consumption. On Friday 10/22/04 around 3AM he went to hospital ER where he was told that the rash was not likely caused by the flu shot, but was more likely a virus. Blood was drawn and was okay. No other diagnostic tests were performed. Prednisone 150 mg or 175 mg was given IM injection and Prednisone 50 mg i p.o. q. am was ordered. On Saturday 10/23/04 around 4 am he returned to the ER for rash and itch not improving. He saw a different doctor than the previous day who said that the rash may be related to something he ate. Prednisone 20 mg prescription given. I advised client that rash client that rash/itch may or may not be related to the flu shot and to call his PCP. He did  so and an appointment was set up for Sunday 10/24/04 at the hospital. Over the phone, doctor advised client to change Prednisone to 25 mg am and 25 mg pm, by cutting 50 mg tablets in half and use up supply. Client called me back after Sunday's visit with doctor and told me that doctor said his rash/itch is related to the flu vaccine and that his body's antibodies are working extra hard to fight off the vaccine. After Prednisone 50 mg's are gone, use Prednisone 10 mg am and 10 mg pm by cutting the 20 mg in half until gone. I spoke to client by phone on Monday 10/25/04. Rash/ itch is improving, but same malaise . Has appointment with doctor today at 3:45 pm at office. 1.5 Prednisone 50 mg tablets left and 10 Prednisone 20 mg tablets left. On Monday 10/25/04 at 11 am. I left a message on client's answering machine to advise doctor if he has been out in the woods lately. Client has a history of heart fibrillation and HTN which he takes medication for. He states that he did not have a reaction to last years flu shot, but that he did have a bad flu, without rash, several times after receiving the flu shot form the railroad.				Y					U	10/19/2004	10/21/2004	2	Blood work 10/22/04 at ER: okay per client	UNK	UNK	Heart HTN meds	NONE	Heart fibrillation, HTN			1						1	Dizziness; Malaise; Pruritus; Pyrexia; Rash; Rash macular	FLU3~SANOFI PASTEUR~U1379AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228608	11/02/2004	AK	67.0	67		M	10/06/2004	Evening of 10/4/04: noticed right arm hurt and it was hard to sleep. No swelling at that time; morning of 10/5: arm still sore. Took 1x Advil, arm sore all day. That night arm swollen and could only lift arm to shoulder, able to sleep. This morning 10/6 arm increased swelling, redness and sore: right arm swollen from deltoid to mid forearm, elbow right arm red and swollen, better ROM this morning. No other symptoms.				Y					U	10/04/2004	10/04/2004	0		PUB	PUB	Vitamins, HCTZ, testosterone patch	NONE	Hypertension		AK200435	1						1	Erythema; Joint range of motion decreased; Pain; Sleep disorder; Swelling; Tenderness	FLU3~SANOFI PASTEUR~u1377aa~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1212M~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0228609	11/02/2004	AK	69.0	68		F	10/14/2004	Had fever on the first day after receiving vaccines. Reported red band around the upper arm below the injection site. Denies any fever, pain or swelling now. The red band is increasing, warm to touch according to the client's daughter.									U	10/11/2004	10/12/2004	1		PUB	UNK		NONE			AK200436	1						1	Erythema; Feeling hot; Pyrexia	FLU3~SANOFI PASTEUR~U1377A~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456R~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0228610	11/02/2004	TN	83.0	83		M	10/19/2004	Doctor presented with redness and swelling to right upper extremity, in area of Pneumovax vaccination SQ area. Stated occurred within 12 hours of receiving vaccine. Area remains slightly reddened.									Y	10/12/2004	10/12/2004	0		PUB	PUB	NONE	NONE	NONE		TN04055	1						1	Erythema; Swelling	FLU3~SANOFI PASTEUR~U1476AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0865N~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0228611	11/02/2004	MI		1	.1	F	10/25/2004	Mom requesting for VAERS form to be filled out. Mom states child developed vomiting the night of 10/15/2004 and is insistant that it was caused by the flu vaccine. Patient seen 10/21/2004 Oral temperature. Vomiting still. Patient education given. Mom still insistent caused.									U	10/15/2004	10/15/2004	0	NONE	PVT	PVT		NONE	Diagnosed with herpangia and vomiting at time of 10/21/04 visit			1						1	Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~61389AB~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~6321P~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A57553A~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0228612	11/02/2004	VA	59.0	59		F	10/25/2004	Bad headaches, chills, fever of 102. Every bone and muscle aching. Difficult breathing, chest hurting. Bad cough with  a lot of congestion. Sore throat with hoarseness. Now I am having bad problem with my kidneys and cramp in legs. Headaches.									U	10/12/2004	10/19/2004	7		PUB	PVT	Tylenol Sinus and Allergy, Amptriptylin, Pancreas Enzymes	NONE				1						1	Chest pain; Chills; Dysphonia; Dyspnoea; Headache; Muscle spasms; Nasal congestion; Pain; Pharyngolaryngeal pain; Pyrexia; Renal impairment	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0228613	11/02/2004	FL	66.0	65		M	10/25/2004	10/14/2004: raised pink spots with deep pink border noted on groin, then back , abdomen, extremities. 10/15: Mycolog cream; Benadryl 50 mg TID. No improvement. 10/19: Medrol dose pack. Resolved 10/25/04.									Y	10/11/2004	10/14/2004	3		UNK	UNK	PPD Shot, Hirapex, Glipizide, Sinemet, ASA, Plavix, Norvas, Alprazolam prn	none	Parkinson, Diabetes Type II			1						1	Rash	FLU3~SANOFI PASTEUR~U1455A~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228615	11/02/2004	TN	1.27	1	.3	F	10/27/2004	5 days after MMR vaccine: Temperature increased to 103 degrees. Fine rash on skin.									Y	10/21/2004	10/26/2004	5		PVT	PVT	NONE	NONE	NONE			1						1	Pyrexia; Rash	DTAP~SANOFI PASTEUR~U1301CA~4~~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1496AA~3~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE227AA~4~~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~1306N~1~~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~495941~4~~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0228616	11/02/2004	OR	2.0	2	.3	F	10/06/2004	Induration of 2.5 inch x 3.0 inch on left leg. Follow up: problem site to be at DTa site per doctor.									Y	10/06/2004	10/06/2004	0		PVT	PUB	NONE	NONE	Congenital adrenal Hyperplasia			1						1	Injection site induration	DTAP~SANOFI PASTEUR~U1314CA~UNK~~~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1389AB~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1123N~UNK~~~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~X1038~UNK~~~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0228617	11/02/2004	CA	6.0	6		M	10/02/2004	Significant redness of upper arm firm elbow to shoulder. Minimal pain; but + pruritus . No fever. Began resolving 3 days after administration. Onset was about 24 hours after vaccine.									Y	10/14/2004	10/15/2004	1		PVT	PVT		none	Allergic rhinitis			1						1	Erythema; Pain; Pruritus	FLU3~SANOFI PASTEUR~01451aa~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228618	11/02/2004	TX	73.0	72		F	10/25/2004	rash: next day at site of injection and shoulder pain next day.									Y	10/13/2004	10/14/2004	1		PVT	PVT	Lubel, Nexium, Gaviscan, Tylenol Arthritis	NONE	Bactrim, CCT2, Levaquin, Adalat, Reglan. Hypertension/ OA/ Osteoporosis			1						1	Injection site rash; Shoulder pain	FLU3~SANOFI PASTEUR~U1410BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228619	11/02/2004	NV	48.0	48		F	10/26/2004	Hives, itching several hours after vaccine administered.									Y	10/23/2004	10/23/2004	0		PUB	PVT	Oral contraceptive	NONE	Allergy: ASA			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1453CA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228620	11/02/2004	TX	64.0	64		F	10/14/2004	Felt cold, started shaking uncontrollably, had muscle aches across back, in arms and legs. Went to ER about midnight. They did blood work and x-ray because patient was having difficulty breathing. 10/13/04: continues to have muscle aches, 'difficulty getting around , very week. Afebrile.				Y					U	09/30/2004	09/30/2004	0	Unknown blood work and chest x-ray	PUB	PVT	Diabetic Meds and inhalers	NONE	Diabetes, Asthma			1						1	Difficulty in walking; Dyspnoea; Feeling cold; Myalgia; Tremor	FLU3~SANOFI PASTEUR~U1439AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228621	11/02/2004	CA	5.0	4		M	10/27/2004	Erythematous area extending from top of arm to mid humus area. Firmness around injection site about around 5 inches wide.									U	10/25/2004	10/26/2004	1		PVT	PVT	NONE	NONE	Asthma			1						1	Erythema; Injection site induration	FLU3~SANOFI PASTEUR~U1440AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228622	11/02/2004	KS	55.0	54		M	10/27/2004	Flu vaccination 10/04/2004 left deltoid. PC 10/27/04 complaints of soreness left arm with weakness. States it started the day of the injection. States he is unable to raise his arm above chest when holding it in front of him. states it's getting worse last couple of days.									U	10/04/2004	10/04/2004	0		PUB	PUB		NONE	Cardiac problems			1						1	Joint range of motion decreased; Muscular weakness; Tenderness	FLU3~SANOFI PASTEUR~U1380AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228623	11/02/2004	NC	4.0	4		M	10/27/2004	Localized reaction left deltoid with 5-7 cm redness. Warm to the touch. Child voices no complaints of pain. Normal ROM. Advised Tylenol x warm compresses QID, RTC if no improvement.									U	10/25/2004	10/26/2004	1		PVT	PUB	Singulair 4 mg QHS	NONE	Asthma			1						1	Erythema; Feeling hot	DTAP~SANOFI PASTEUR~U1300CA~5~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1439AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X0711~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1036N~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0228624	11/02/2004	NY	77.0	77		F	10/26/2004	10/21/04: developed rash . 10/22/04: seen by clinic. Rash perisists.				Y					U	10/19/2004	10/21/2004	2		OTH	PUB	Lasix, Phenytoin, Prednisone, Albuterol, Flonax		Codeine Allergy, COPD, Lupus, CMF			1						1	Rash	FLU3~SANOFI PASTEUR~U1462AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228625	11/02/2004	TN	64.0	63		F	10/21/2004	Reported soreness beginning 8 hours after injection. Redness/ swelling noticed 2 days later. Fever in local area reported today (third day after injection).									Y	10/18/2004	10/19/2004	1		PUB	PUB	Metformin, Lisinopril, ASA, Synthroid, Glyburide, Metoprolol, Zocor	NONE	Diabetic/ thyroid/ increased blood pressure		TN04060	1						1	Erythema; Pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U1489AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228626	11/02/2004	WI	54.0	53		F	10/25/2004	On 10/13/04, when I woke up and tried getting out of bed, the room spun so violently that I thought I was going to pass out! When I tried laying down the same thing happened. When I did manage to get out of bed, I felt dizzy and extremely nauseated. I called my husband at work who called a friend to come check on me. Everytime I tried to lay down, the room seemed to spin out of control. Even when my friend did manage to help me back to bed, the extreme dizziness and nausea persisted.				Y					U	10/05/2004	10/12/2004	7	Ears were examined:nomal. Temp: normal. CT scan: normal, vitals: normal. Blood work: normal. Overall exam: normal.	OTH	UNK	Effexor, Keppro, Amphetamine, Calcium and Vitamins	NONE	Codeine, Sulfa-based drugs, Latex, Lamictal, Aspirin sensitive.			1						1	Dizziness; Nausea; Vertigo	FLU3~SANOFI PASTEUR~U1440AA~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0371P~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0228628	11/02/2004	IA	50.0	49		M	10/28/2004	Had sharp pain at arm; muscle spasm, sweats, involuntary muscle spasm,causing motor vehicle accident.				Y					Y	10/25/2004	10/27/2004	2	had EKG; blood counts	PVT	UNK		NONE	AODM (Type II Diabetes)			1						1	Hyperhidrosis; Muscle spasms; Pain	FLU3~SANOFI PASTEUR~U1443AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228629	11/02/2004	WI	87.0			M	10/26/2004	Painful right arm: unable to abduct at injection site.									N				NONE	PVT	PVT						1						1	Joint range of motion decreased; Myalgia	FLU3~SANOFI PASTEUR~U1380AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228662	11/02/2004	PA	48.0	47		F	11/02/2004	approximately 2 days post vaccine, recipient developed tingling in left armpit radiating to left breast nipple.  Vaccine recipient now (11/2/04) describes electrical current-like, tickle sensation in same area as noted above and across upper back.				Y					N	10/14/2004	10/16/2004	2	mammogram performed in light of breast cancer history	UNK	UNK	waiting response from recipient	waiting for response from recipient	history of breast cancer			1						1	Paraesthesia	FLU3~SANOFI PASTEUR~1438AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228664	11/02/2004	NC	30.0	30		F	11/02/2004	Pt is a plastic surgery resident who noticed numbness and tingling in her left lower extremity following a flu shot on 10/25.  Sx progressed to involve paresthesias and abnormal sensations in both lower extremities and then the upper extremities.  She also noticed decreased coordination while at work although mentation remained sharp.  Pt denied any sports or trauma injuries, any recent travels, or any new foods.  She did note some chronic shoulder sx which were musculoskeletal in nature and related to posture and ergonomics from doing long surgeries at work.  Diagnosis was possible Guillain-Barre syndrome.  MRI was significant only for mild multi-level DJD, but there was no cord compression and no lesions noted in the brain or cord.  On 10/28, the pt was thought to have some weakness on exam along with her sensory changes.  An EMG perfomed 10/28 failed to show any evidence of a neuropathy, but it was believed that the pt's onset timing was too acute and that repeat EMG and repeat LP may have shown changes more consistent with GB syndrome.  Throughout her hospital stay, pt did endorse neuropathic changes noting paresthesias in her arms and legs which later progressed to her trunk.  Pt was discharged on 10/29 with a scheduled f/u appointment with Neurology.  Pt was improved at time of discharge although it was still not fully clear as to the cause of her neuropathic sx.  01/25/05 Discharge Summary of 10/27-10/30/2004. FINAL DX: Probable GBS Patient experienced problems with numbness and tingling in lower extremity day of flu shot.  Symptoms were progressive and she was admitted 2 days' later and treated aggressively w IVIG therapy.  Neuro consults for origional evaluation at admission and when blood patch placed.  She was successfully treated for post LP headache with a blood patch.  02/02/05 Neuro Clinic records: Post discharge office evaluation. Findings at that time showed minimal residual changes and that she was back to work, if not for the prolonged periods she had tolerated prior to the attack.					Y	4			Y	10/25/2004	10/26/2004	1	MRI, EMG - See above.  LABS: MRI of brain/cervical spine (normal Brain, minor degenerative changes in spine).  CSF with protein at 28, glucose at 49, oligoclonal bands absent, cytology neg.  EMG done 10/28/04 showed no evidence of neuropathy.	UNK	UNK						1						1	Coordination abnormal; Guillain-Barre syndrome; Headache; Sensory disturbance	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0228672	11/02/2004	HI	2.0	2	.0	M	11/02/2004	after returning home from visit, felt warm to touch. no temperature taken. then approximately 24 hrs after administration of Influenza vaccine, developed bilateral eyelid swelling and hives. was given Benadryl, Tylenol and Advil. seen in clinic 2 days after administration of vaccine. T101.1. still with bilateral eyelid swelling and erythema. no rash present. discharged home to continue symptomatic treatment.				Y					U	10/29/2004	10/31/2004	2		UNK	UNK	Rhinocort 1 spray each nostril qd Sinulair 4mg qd Flovent 110, 1 puff qd prn Albuterol	has had 2 weeks cough which was reportedly resolving	asthma allergic rhinitis, dust mite allergy by skin testing short stature			1						1	Erythema; Eyelid oedema; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U1416AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228675	11/02/2004	CA	56.0	56		F	10/27/2004	Numbness right side of cheek and lip. Follow up: First office visit 10/27/04. Diagnosis: reaction to flu vaccine. No treatment given. Seen for FU 10/29/2004 and had improved.									U	10/01/2004	10/25/2004	24		UNK	UNK			Diabetes; Hyperlipidemia			1						1	Hypoaesthesia	FLU3~SANOFI PASTEUR~U1449AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228676	11/02/2004	OH	39.0	38		F	10/27/2004	Localized red reaction with hard area R/T flu vaccine.									U	10/25/2004	10/25/2004	0		UNK	UNK						1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U1455CA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228677	11/02/2004	CA	93.0			F	10/26/2004	After flu vaccine was injected, patient became very delusional with hallucinations and malaise. She believed there were people in the room when there were actually no one present. She was in her own bed and she believed she was in a hotel overseas. She became irate and demanded we take her home. This is very unusual behavior on her part. She has never been diagnosed with Alzheimers.									U	10/23/2004	10/25/2004	2		UNK	UNK	Coumadin		The only medical condition was congenital heart problems that was originally diagnosed in 1916. Takes Coumadin.			1						1	Abnormal behaviour; Delusion; Hallucination; Malaise	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0228678	11/02/2004	MT	58.0	58		F	10/18/2004	Individual given influenza vaccine (as is in high risk group) on 10/4/04 in left deltoid without difficulty. Later that day, developed diffuse maculopapular rash on stomach, sides, back armpits, and down arms and mild itching. 2 days later swelling to tongue. Doctor prescribed tapering doses of Prednisone for 6 days; still requiring Allegra. Symptoms are decreased in severity but still persist as of this date 10/18/04. Follow up 02/4/05: symptoms resolved entirely after several days, no complaints since then.								Y	Y	10/04/2004	10/04/2004	0	No labs. Future vaccination has been contraindicated by treating MD.	UNK	UNK	Prednisone; Allegra		Only reported allergies: Bactrim - hives 4 years ago; Codeine 35 years ago; Irritable; No medical problems. No current medications.			1						1	Pruritus; Rash maculo-papular; Tongue oedema	FLU3~SANOFI PASTEUR~U1379AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0228682	11/02/2004	MN	57.0	56		F	11/02/2004	Received flu shot 10/29/04. Site was hard and tender Saturday as reddened, hard area 2.5x2.5. Area around injection site warm and red. By Tuesday when reported, area had decreased in swelling and hard area but still red and round. Very tired and decreased energy Sunday and Monday. Some shortness of breath. Monday with frequent cough. Treatment: Monitor for now.									Y	10/29/2004	10/30/2004	1	NONE	PUB	PVT	NONE	NONE	NONE			1						1	Cough; Dyspnoea; Fatigue; Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth; Tenderness	FLU3~SANOFI PASTEUR~U1380AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228684	11/02/2004	WA	76.0	76		F	11/02/2004	Right arm pain, red, hot, and lump at injection site. Redness and pain spread from site to 2-3 below elbow. Patient treated with ES Tylenol, cold compressions until doctor's appointment. Doctor treated with Rocephin IM, Zyrtec for 10 days and Keflex for 10 days.				Y					U	10/29/2004	10/29/2004	0	NONE	OTH	OTH	Prilosec; Tylenol; Citrical; Atacand; Loscal	NONE	Allergy to sulfa			1						1	Injection site erythema; Injection site mass; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U1504AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0864N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0228685	11/02/2004	UT	45.0	44		M	11/01/2004	Patient complained of severe pain in left arm. Patient describes as sore to touch, not an ache. Started approximately two days status post injection. Site of pain is below injection site. Pain worse yesterday and improving today. No redness or swelling.									N	10/28/2004	10/30/2004	2	NONE	PVT	PVT		NONE	NONE			1						1	Pain	FLU3~SANOFI PASTEUR~U1418AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228686	11/02/2004	MN	46.0	46		F	11/02/2004	Immunized with 0.5ml Fluzone at approximately 9:30 AM. 12:40 PM, feet itchy and flushed upper left arm with redness of area, followed by flush/dizzy spells and tightness across chest. Seen in ER; blood pressure and heart rate increased. Symptoms lasted about 3 hours then subsided gradually.				Y					Y	11/01/2004	11/01/2004	0	NONE	PUB	PVT	NONE	NONE	NONE			1						1	Blood pressure increased; Chest discomfort; Dizziness; Flushing; Heart rate increased; Injection site erythema	FLU3~SANOFI PASTEUR~U1380AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228693	11/02/2004	VA	1.69	1	.7	M	11/02/2004	Swollen right upper eyelid (second patient: with this after follow up shot) Pupil and conjunctiva normal.									Y	10/25/2004	10/27/2004	2		PVT	PVT		URI, mild, no fever	Eczema, Anemia			1						1	Eye swelling	FLU3~SANOFI PASTEUR~U1421AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228695	11/02/2004	OR	50.0	49		F	11/02/2004	Patient states went to hospital ER 10/23 with temperature of 103 and severe upper left arm pain. Status post Fluzone and PCV7 vaccine 10/21. On 10/26/2004 evaluated at clinic with ongoing severe left upper arm pain, warmth and redness. Diagnosed with cellulitis.				Y					Y	10/21/2004	10/22/2004	1		PUB	UNK		NONE	Fibromyalgia, IM type II, Obesity			1						1	Cellulitis; Erythema; Feeling hot; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1496AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0190P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0228702	11/03/2004	TX	1.17	1	.2	M	11/03/2004	Erythematous papular rash over face, trunk, and extremities 10 days after injection.  Associated low grade temperature.  No treatment.									Y	10/25/2004	11/02/2004	8	None	UNK	UNK	None	Acute otitis media	None			1						1	Pyrexia; Rash erythematous; Rash papular	FLU3~SANOFI PASTEUR~U1417AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~UNKNOWN MANUFACTURER~X0707~3~SC~RL~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0954N~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A83578E~3~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0117P~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0228705	11/03/2004	ID	28.0	28		F	11/03/2004	Redness, heat, and sweeling at the injection site on 11-2-04 C/o Headache on 11-1-04 at 3:30pm Nausea and vomiting excitable affect and slight confusion				Y					Y	11/01/2004	11/01/2004	0		UNK	UNK		none				1						1	Confusional state; Headache; Injection site erythema; Injection site swelling; Injection site warmth; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U1453FA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228707	11/03/2004	CA	38.0	37		F	11/03/2004	Had flu shot on 10/27 at approx. 11 am, presented with C/O horseness and SOB at approx. 3 pm. Referred to Emergency room where treated for reaction. Meds given-benadryl,prednisone, pepcid, ativan, epinephrine by nebulizer treatment. Patient was discharged to home. Infoirmation from Medical records states ancxiety. msv				Y					Y	10/27/2004	10/27/2004	0		UNK	UNK	UNKNOWN	NONE	NONE Information from medical records states asthma. msv			1						1	Anxiety; Dysphonia; Dyspnoea	FLU3~SANOFI PASTEUR~U1456AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228708	11/03/2004	KY	41.0	40		F	11/03/2004	numbness tongue tip, roof of mouth, bottom lip									Y	10/01/2004	10/07/2004	6	did not seek treatment - asked opinion of neurologist she works with and they expressed thought that symptoms could be vaccine related	UNK	UNK	none	none	none			1						1	Hypoaesthesia oral	FLU3~SANOFI PASTEUR~U1458AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228709	11/03/2004	IL	54.0	53		F	11/03/2004	Pt presented in ER at 17:02 hours with hives,itching and nausea since noon today (11/02/2004). Was started on IV with Benadryl and Solumedrol and monitored. She was DC on Medrol pack and Benadryl. To follow-up with family MD.				Y					Y	11/01/2004	11/02/2004	1	.	UNK	UNK	Evista, Lexapro, Dilantin, Lisinopril,Linoxin, Topril XL, ASA,		CHF, Seizures, Depression			1						1	Nausea; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1459AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228711	11/03/2004	TX	45.0	44		F	11/03/2004	PATIENT GOT FLUZONE DOSE ON 10/13. CALLED ME ON NOV 1 SAYING SHE HAS HAD UPPER ARM PAIN SINCE SHE GOT SHOT. HER DR PUT HER ON DARVOCET N 100. ON NOV 1, DR ALSO PRESCRIBED DARVOCET N 100 & MEDROL DOSEPAK. DR TOLD HER THE NEEDLE EITHER HIT BONE OR NERVE. PAIN MOVED TO AREA JUST ABOVE ELBOW, FEELS LIKE TIGHT RUBBER BAND AROUND ARM. FOLLOWED UP WITH DOCTOR 11/3. WHO IS REFERRING HER TO NEUROLOGIST. FOLLOWED UP WITH THE PATIENT 11/3, SAYS SHE IS FEELING BETTER TODAY, HAVE NOT TAKEN DAVOCET TODAY, BUT USUALLY IS WORSE AT NIGHT. TOLD HER TO KEEP IN TOUCH WITH US				Y					U	10/13/2004	10/13/2004	0	UNKNOWN	UNK	UNK	UNKNOWN	PATIENT ANSWERED NO ON CONSENT FORM	PATIENT ANSWERED NO ON CONSENT FORM			1						1	Pain	FLU3~SANOFI PASTEUR~U1443AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228712	11/03/2004	CA	53.0	52		M	11/03/2004	Shingles (Herpes zoster) noted approx 80 hrs after flu vaccine									Y	10/26/2004	10/29/2004	3		UNK	UNK						1						1	Herpes zoster	FLU3~SANOFI PASTEUR~U1456AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228716	11/03/2004	IL	33.0	33		F	11/03/2004	DKA  (Diabetic ketoacidosis) 4 days after flu shot received. Patient was in ICU and recovered.			Y	Y	Y	7	Y		Y	10/20/2004	10/24/2004	4		UNK	UNK			DM I (thought to be DM II).			1						1	Ketoacidosis	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0228717	11/03/2004	GA	82.0	82		M	10/24/2004	Tuesday 1:00 AM, woke up with headache, sweating, vomiting, fever. Taken to hospital; stayed until Thursday. Did lots of testing; could not find anything. Ruled out all except flu shot (per wife). Discharge Summary received on 1/3/2005 states pneumonia, cough, anorexia, and vertigo. Medical Record received on 1/3/2005 states pneumonia, cough increased, anorexia and vertigo.					Y	1			Y	10/18/2004	10/20/2004	2	Discharge Summary received on 1/3/2005 states chest film abnormal.	OTH	PVT	UNK		Discharge Summary received on 1/3/2005 states cerebral bleeding, atrial fibrillation, sick sinus syndrome/pacer, spinal stenosis, lower extremity neuropathy, and aneurysm. Medical Record received on 1/3/2005 states prostititus, venus status ulcers, dementia, and cardiomegaly.			1						1	Cough; Fatigue; Headache; Hyperhidrosis; Lung disorder; Pneumonia; Pyrexia; Vertigo; Vomiting	FLU3~SANOFI PASTEUR~U1504AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0228718	11/03/2004	VA	1.16	1	.2	M	10/28/2004	Baby received flu vaccine 0.25ml IM first time. 2 hours later, presents with vomiting, anorexia, fever. fussiness, cough lasted from 10/21/04 to 10/26/04. On 10/25/04, admitted to hospital for dehydration. Admission 24 hours and discharged home recovered after IV fluids. Medical Records received on 12/07/2004 states rash.					Y	1			Y	10/21/2004	10/21/2004	0		PVT	PVT	NONE	NONE	History of RAD; used nebulizer 2 times.			1						1	Anorexia; Cough; Dehydration; Irritability; Pyrexia; Rash; Vomiting	FLU3~SANOFI PASTEUR~U1403AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0228721	11/03/2004	TX	53.0	53		F	11/02/2004	Patient had 102.5F fever during the night following the shot, had chills , and ached in joints and back. Fever went down to 101.0F 24 hours after shot. All symptoms gone by 6PM next day.									Y	10/04/2004	10/04/2004	0		UNK	PVT	NONE	NONE	NONE			1						1	Arthralgia; Back pain; Chills; Pyrexia	FLU3~SANOFI PASTEUR~U1440aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228722	11/03/2004	MD	47.0	47		M	10/28/2004	chills, flu-like symptoms around about 12am midnight on the same day, shot was administered on 10/27/2004. Note : patient administered self injection of Copaxone (SQ) cIDPM on 10/27/04. He takes this daily. Patient stayed home in bed today 10/28/04. Patient returned to work 10/29/04.									Y	10/27/2004	10/27/2004	0		MIL	MIL	Copoxane for MS	Has had MS, since 1995	MS , since 1995			1						1	Chills; Influenza like illness	FLU3~SANOFI PASTEUR~U1459AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228723	11/03/2004	WI	51.0	51		M	11/03/2004	Developed blisters right deltoid area, itching in right deltoid area.				Y					Y	10/29/2004	11/01/2004	3		PVT	UNK	ASA; HCTZ; Lisinopril; Synthroid; Rontidine	None	HTN, Hypothyroid, GERD, Depression, COPD; No Previously Known Drug Allergies; MR			1						1	Injection site pruritus; Injection site vesicles	FLU3~AVENTIS PASTEUR~U1383AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0531P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0228724	11/03/2004	AL	66.0	66		M	10/13/2004	5 min after shots, had pain in lower back , tingling in legs and face and leg weakness. Pain got progressively worse for 5 minutes then began to abate. After 30 min symptoms mostly gone. Only slight feeling of weakness.									Y	10/13/2004	10/13/2004	0		UNK	PVT						1						1	Back pain; Muscular weakness; Paraesthesia	FLU3~SANOFI PASTEUR~U1440AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0864N~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0228725	11/03/2004	CA	13.0	13		F	10/26/2004	Hour after flu vaccine, patient had loss of sensation: left arm and rest of body. Curled up in fetal position. Went to Hospital ER: had second episode 24 hours later. Went to hospital ER.				Y					Y	10/25/2004	10/25/2004	0		PVT	PUB	Zaditor eye drops	Itchy eye	Asthma, History of muscle tic			1						1	Depressed level of consciousness	FLU3~SANOFI PASTEUR~U1417AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228726	11/03/2004	MO	1.26	1	.3	F	10/28/2004	Child had extensive erythema right thigh/ increased warmth/ induration around 36 hours after DTAP injection. No alteration of consciousness. No fever. Parents very upset.									Y	10/26/2004	10/27/2004	1	NONE	PVT	PVT		NONE	NONE			1						1	Erythema; Feeling hot; Injection site induration	DTAP~SMITHKLINE BEECHAM~59289~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~W496AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A83578E~4~~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0228727	11/03/2004	WA	61.0	61		F	10/25/2004	Soreness and pain in arm and neck , in left arm and left side of neck is constant. Shot was given in right arm.									U	10/06/2004	10/07/2004	1		UNK	PVT		NONE	NONE			1						1	Myalgia; Neck pain; Tenderness	FLU3~SANOFI PASTEUR~U1438AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228728	11/03/2004	MA	4.0	3		M	10/27/2004	Vomiting									U	10/26/2004	10/26/2004	0		PVT	UNK	UNK					1						1	Vomiting	FLU3~SANOFI PASTEUR~U1427AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228729	11/03/2004	PA	4.0	4		F		5 minutes following the shot: had turned pale sweaty and vomited once. Epinephrine 0.22cc given.									Y	10/08/2004	10/08/2004	0	NONE	PVT	PVT		NONE	NONE			1						1	Hyperhidrosis; Pallor; Vomiting	FLU3~SANOFI PASTEUR~U1489AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228730	11/03/2004	NY	42.0	41		F	10/28/2004	Pneumovax site was painful after injection. Extremely painful 3 hours after injection. Very large local reaction 9 area of redness: 4' x 2.5 inch raised reddened area around injection site. Pain shoulder to mid humorous. Fatigue, diaphoresis, headache, site warm to touch. Symptoms resolving after first day.									Y	10/26/2004	10/26/2004	0		PUB	UNK	Advair 250/50 with puff BID. Ranitidine 150 PO QD	NONE	Asthma, MVP, allergic to mold.			1						1	Fatigue; Headache; Hyperhidrosis; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pain	FLU3~SANOFI PASTEUR~0987N~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0987N~3~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0228731	11/03/2004	NJ	3.0	2	.7	M	10/28/2004	Unstable gait (Ataxia) and tremors started 10/10/04...About 6 Days after vaccine (Flu Vaccine) Given. Seen by pediatric neurologist and diagnosed with post vaccination Cerebellisis. Medical records state Otitis, cerebellitis.				Y					U	10/04/2004	10/10/2004	6	CT of Head/ CBC, CMP, CA, PHJS AU okay	PVT	PVT	NONE	Slight Nasal Congestion	Improving Speech Delay			1						1	Cerebellar syndrome; Coordination abnormal; Gait disturbance; Nervous system disorder; Otitis media; Tremor	FLU3~SANOFI PASTEUR~U1403AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228732	11/03/2004	MA	9.0	9		F	10/28/2004	3 cm in diameter erythema, slightly raised lump on left forearm				Y					Y	10/27/2004	10/28/2004	1		PVT	PUB			Asthma			1						1	Erythema; Injection site mass	FLU3~SANOFI PASTEUR~U1439AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228733	11/03/2004	WI	77.0	76		F	10/28/2004	Localized itching, edema, redness and warmth around 15 cm diameter at site of injection. Starting around 6 hours after administration, evaluated around 24 hours after administration.				Y					Y	10/27/2004	10/27/2004	0		PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U1449AA~7+~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0529P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0228734	11/03/2004	PA	1.72	1	.7	F	10/26/2004	Hives within 24 hours of vaccine. No anaphylaxis. No wheezing. No other detailed factors.				Y					Y	10/25/2004	10/26/2004	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1476AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228735	11/03/2004	OK	61.0	61		F	10/28/2004	Red area around injection site 3 inches in diameter. Irritated looking. Not raised or warm to touch. No fever or SOB.									Y	10/26/2004				PVT	UNK		NONE	PCN and AZO standard only allergies			1						1	Injection site erythema; Skin irritation	FLU3~SANOFI PASTEUR~U1517AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228736	11/03/2004	VA	6.0	6		F	10/25/2004	Rash on legs, left foot swollen, noticed rash the same night of Flu shot given. No redness at site of injection.									U	10/22/2004	10/22/2004	0	CBC 12.8, WBC 615, 29L 8M, 2E, Pl Ct 381000, CRP 6.1 (normal 0.0-4.9)	PVT	PVT	NONE	NONE	NONE			1						1	Laboratory test abnormal; Oedema; Rash	FLU3~SANOFI PASTEUR~U1580AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228737	11/03/2004	WA	3.0	3		F	10/27/2004	Asking to be held she was crying, her behavior, she was angry and mad, she was wheezing, paleness and had small bumpy all over her neck and arms. The bumps went away after 1 week and has a cough still.				Y					Y	10/15/2004	10/16/2004	1		OTH	OTH	Albuterol inhaler	Beginning of cold (not sure)	Asthma, hospital in March 03 of the Flu			1						1	Agitation; Anger; Cough; Crying; Pallor; Rash; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~LA~HEP A (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0228740	11/03/2004	CO	53.0	53		F	10/25/2004	3 days after shot developed purulent ring around inj site, 5 days later vomiting and high fever. Pt says she believes she developed a staph infection at injection site which spread to face and ears (pt developed boils in ear and around airline). Fever, vomiting resolved, injection site reaction improving but still there.									Y	10/01/2004	10/03/2004	2		OTH	PVT	Lamictal, Prometrium, others UNK	UNK	UNK	severe purple rash~Vaccine not specified (no brand name)~0~0.00~In Patient		1						1	Furuncle; Injection site infection; Injection site reaction; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1448AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228741	11/03/2004	PA	13.0	12		F	10/27/2004	Flu shot given 10/21/2004: seen in office 10/22/04 with fever, headache and left hip pain.				Y					U	10/21/2004	10/22/2004	1		PVT	PVT	Advair, Singulair, Asacol	NONE	IB, Inflammatory Bowel Dis			1						1	Headache; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1409BA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228751	11/03/2004	VA	4.0	4		M	10/29/2004	A DPT and IPV given in anterior left thigh with 4.5cm by 11.5cm erythematous pseudopodal rx 6 other symptoms									Y	10/26/2004			NONE	PVT	PVT	Singulair 4mg 9HS	NONE	Asthma			1						1	Injection site erythema	DTAP~SANOFI PASTEUR~C2104AA~5~~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1476AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1212~4~~LL~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0228779	11/04/2004	NE	49.0	48		F	11/04/2004	Severe vomiting began one week after vaccine administered.  Vomiting lasted approx. 18 hours.  I had the same reaction last year approx. two weeks after receiving vaccine.  I went to the ER for treatment last year and explained that I had had a flu shot recently, but they dismissed that information.									Y	10/15/2004	10/22/2004	7		UNK	UNK	Amaryl 4mg 1/day Benazepril 10 mg 1/day Hydrochlorothiazide 12.5 mg 1/day	None	Diabetes, high blood pressure, obesity	Severe vomiting, dehydration, low potassium~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0228782	11/04/2004	MD	66.0	66		F	11/04/2004	Developed sx of herpes zoster on 10/29.  Received influenza vaccine on 10/26. Dx w/ herpes zoster on 11/1.									Y	10/29/2004			none	UNK	UNK	prozac, zocor, avandia, lipizide, allegra, toporal	none	allergic to everything, high cholesterol, niddm, high blood pressure, heart murmur			1						1	Herpes zoster	FLU3~SANOFI PASTEUR~U1496AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228784	11/04/2004	MD	1.53	1	.5	F	11/04/2004	10/27/04 @ 1700 - received vaccination in rt thigh; 10/29/04 @ 0010 to 10/31/04 @ 1130 - pt fussy and hives appeared on face, trunk (front and back),upper and lower extremities; Benadryl given during this time per PCP									Y	10/27/2004	10/29/2004	2	None	UNK	UNK	None	None	None			1						1	Irritability; Urticaria	FLU3~SANOFI PASTEUR~U1479AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228785	11/04/2004	MN	60.0	60		M	11/04/2004	Pt presents to clinic two days after receiving both the flu and pneumococcal vaccines at the same time in the right arm.  Pt presents with right arm pain which manifested within a few hours of receiving the shots.  Pt noted redness and swelling of the arm (20cm diameter) and general 'ill' feeling (fever and chills).  Pt also experienced some exacerbation of asthma with coughing.  Pt took 25-50mg diphenhydramine which helped a great deal with the redness.  Coughing is resolving.  No other treatment at this time.  Pt has had the flu shot in the past with no adverse reactions.				Y					U	11/02/2004	11/02/2004	0		UNK	UNK			Allergies: PCN, erythromycin derivatives, Levaquin, Tetanus-diphtheria	Unknown~Td Adsorbed (no brand name)~~0.00~In Patient		1						1	Asthma; Chills; Cough; Injection site erythema; Injection site swelling; Malaise; Pain	FLU3~SANOFI PASTEUR~U1380AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0228786	11/04/2004	TX	0.51	0	.5	M	11/04/2004	Egg allergic infant with urticaria and angioedema of eyelids 2 hours after receiving infanrix, influenza vaccine and PREVNAR.			Y						Y	09/28/2004	09/28/2004	0	RAST for egg yolk class 4 (4.89) and egg white class 4 (20.7)	UNK	UNK		None	None			1						1	Angioneurotic oedema; Eyelid oedema; Laboratory test abnormal; Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~639BP~3~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1389AB~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~74398B~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Life Threatening	Influenza
0228787	11/04/2004	CA	86.0	85		F	11/04/2004	GRADUAL DEVELOPMENT (MILD TO SEVERE) REDNESS, SWELLING, PAIN, WARMTH TO TOUCH TO LEFT UPPER ARM 24-48 HOURS AFTER RECEIVING FLU VACCINE AND PNEUMOVAX TO LEFT DELTOID ON 11/01/04. GIVEN RX FOR KEFLEX 500MG, ADVEISED TO TAKE OTC BENADRYL, TYLENOL PRN FOR PAIN AND FEVER.				Y					U	11/01/2004	11/01/2004	0	N/A	UNK	UNK		NONE	NKA SEBORRHEIC DERMATITIS GLAUCOMA RHEUMATOID ARTHRITIS			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U145600~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0513P~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0228789	11/04/2004	FL	0.8			M		10 month old male received PCV, Hep B, and Flu immunizations at same visit. Returned in 3 hours with profuse urticaria.									U	10/25/2004	10/25/2004	0	NONE	UNK	UNK	Patient is asthmatic and has been on maintenance nebulizer treatments BID of Pulmicort plus Xopenex.		Mild persistent asthma with periodic exacerbations with URI.		A74398B	1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|PNC~PFIZER\WYETH~A74398B~UNK~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0228794	11/04/2004		41.0	40		F	10/29/2004	Severe headaches w/ nausea and vomiting, dehydration etc x 8 days				Y					U	10/14/2004	10/21/2004	7	CBC with differential, UA, TSH, T4, CMP	UNK	UNK			HTN			1						1	Dehydration; Headache; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U1450AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228795	11/04/2004	OH	70.0	70		F	11/01/2004	After four hours developed red ring about vaccine injection site then entire arm became swollen to wrist. Client reports swelling was severe enough she could not raise her arm. 72 hours after inj mild swelling persists in arm and elbow area with c/o joint pain. Benadryl helped a little. Dr advised using Motrin 2 BID and call if symptoms persist. Follow Up: Reaction at Pneumovax site.				Y					N	10/29/2004	10/29/2004	0	NONE	PUB	PUB	Amytriptoline, Atenolol, Synthroid, Fosamax, Zocor	NONE	High Blood Pressure, Osteoporosis			1						1	Arthralgia; Hypokinesia; Injection site erythema; Injection site reaction; Oedema	FLUX~UNKNOWN MANUFACTURER~~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~M0529N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0228796	11/04/2004	MD	46.0	46		F	10/22/2004	Immediately after administration of Flumist, Pt felt nauseous. Within 15 minutes she noticed tingling in her hands and feet which lasted for a couple hours. Pt noticed intermittent tingling the next morning.									Y	10/21/2004	10/21/2004	0		PVT	PVT		NONE	NONE			1						1	Nausea; Paraesthesia	FLUN3~MEDIMMUNE VACCINES, INC.~500337P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0228797	11/04/2004	IL	9.0	9		M	10/25/2004	Pt had flat area of erythema, slightly warm to touch 2x3cm with irregular boarder, 4cm below injection site negative protein stain, injection site with erythema given Keflex PO.				Y					Y	10/21/2004	10/22/2004	1	NONE	PVT	PVT	Advair, Singular, Albuterol	NONE	Asthma, Hypercalcemia, with h/o stress fractures.			1						1	Feeling hot; Injection site erythema	FLU3~SANOFI PASTEUR~U1417AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0746P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0228799	11/04/2004	MD	15.0	15		F	10/07/2004	Mother called office on 10/1/04 to report seen at pt first evening of immunizations for difficulty breathing and throat constriction. Reports given IM Benadryl w/resolution of symptoms.				Y					Y	09/28/2004	09/28/2004	0	UNK	PVT	PVT	Zoloft 100mg every day	Mild URI	Asthma, Seasonal Allergies			1						1	Dyspnoea; Throat tightness	FLU3~SANOFI PASTEUR~U1383AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0607P~1~IM~RA~HEP B (RECOMBIVAX HB)~1|TD~AVENTIS PASTEUR~U1347AA~6~IM~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0228819	11/05/2004		87.0			F	11/04/2004	This case concerns an 87 year old female pt.  The pt received a 0.5ml dose of influenza vaccine, manufacturer unknown, batch # not reported, given IM on 09/30/04.  On 10/1/04 the pt died at home during sleep. A post mortem was carried out, the cause of death was established as acute myocardial infarction. The pt was taking the following concomitant medications: Omeprazole, 20mg per mouth for gastritis since 01/17/00; Bendroflumethiazide, 2.5mg per mouth for essential hypertension since 03/18/03; Enalapril, 2.5mg per mouth for essential hypertension since 03/11/03; Salbutamol, 100mcg inhaler for acute bronchitis NOS between 04/22/03 and 08/11/04 and paracetamol 500mcg per mouth for localized osteoarthritis since 03/17/97.  No further information is expected, case is closed.	Y								N	09/30/2004	10/01/2004	1		UNK	UNK	Omeprazole, Bendroflumethiazide, Enalapril, Salbutamol, Paracetamol.		The pt was taking the following concomitant medications: Omeprazole, 20mg per mouth for gastritis since 01/17/00; Bendroflumethiazide, 2.5mg per mouth for essential hypertension since 03/18/03; Enalapril, 2.5mg per mouth for essential hypertension since 03/11/03; Salbutamol, 100mcg inhaler for acute bronchitis NOS between 04/22/03 and 08/11/04 and paracetamol 500mcg per mouth for localized osteoarthritis since 03/17/97.		E200403742	1						1	Myocardial infarction	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0228828	11/05/2004	UT	40.0	40		F	11/02/2004	Flu shot given approximately 11:00am. Client had indicated she had no allergies. 11:45 client returned complained of itching and red rash on neck. No wheezing or SOB. Denies dizziness, lightheadedness. Given Chlorpheniramine 90 mg tab PO. Observed x 30 min symptoms resolving by 12:20. After reaction client remembered previous allergic reaction to thimerosal in contact solution. Client counseled to only vaccine thimerosal free vaccine in future.									Y	11/02/2004	11/02/2004	0		UNK	PVT	NONE	Recovering from bronchitis				1						1	Erythema; Hypersensitivity; Pruritus; Rash	FLU3~SANOFI PASTEUR~U1479AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~SMITHKLINE BEECHAM~028AA~2~IM~RA~HEP A + HEP B (TWINRIX)~1	USA		Influenza
0228829	11/05/2004	CA	1.28	1	.3	M	11/04/2004	DTaP no. 4/ Influenza given at 10:45 am. Hives noted on face then diffuse on chest and back. Benadryl 50mg 1/4cc IM given 10:42am 028A5 98%. HR 130-140s.  RR40s. Transferred to hospital ER department. Check paramedic/ fire department left in stable condition requiring no treatment at 11AM.				Y					U	11/04/2004	11/04/2004	0		PUB	PUB	NONE	URI	NONE			1						1	Urticaria	DTAP~SANOFI PASTEUR~U12140A~4~IM~~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1454AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228830	11/05/2004	PR				U	11/01/2004	Consumer was administered with the influenza vaccine on 9/15/04. She started to feel discomfort at the time to urinate. Next Monday she was bleeding large blood clots. She went to the VA Emergency Room and doctor prescribed her with antibiotics.				Y					U	09/15/2004	09/16/2004	1		UNK	UNK						1						1	Discomfort; Dysuria; Vaginal haemorrhage	FLUX~UNKNOWN MANUFACTURER~45R801~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0228831	11/05/2004	WA	32.0	32		F	10/06/2004	Pain left deltoid to midsternal down to below left breast: down to finger tip. Achy pain.				Y					Y	10/05/2004	10/05/2004	0		MIL	UNK	Zoloft, Texaphenadine, Loestern		Tree weeds, grass, dust mites, chronic sinusitis, increased cholesterol, Ovarian cystic.			1						1	Chest pain; Pain	FLU3~SANOFI PASTEUR~U1447AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228832	11/05/2004	WA	50.0	49		F	10/08/2004	Pain at right deltoid, right shoulder, right neck. Ecchymosis at site, hot to touch, increased bleeding at site. No anticoagulant meds or bleeding disorders.									U	10/07/2004	10/07/2004	0		UNK	UNK	Atenolol, Advil					1						1	Injection site haemorrhage; Injection site warmth; Pain	FLU3~SANOFI PASTEUR~U1447AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228866	11/05/2004	NC	48.0	47		F	11/05/2004	Nausea, vomiting, diarrhea approximately 40 hours after vaccine administration. Mild soreness at vaccine site.									Y	11/03/2004	11/05/2004	2	None	UNK	UNK	none	None	None			1						1	Diarrhoea; Injection site pain; Nausea; Vomiting; Diarrhoea; Dizziness; Hyperhidrosis; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1445AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0228869	11/05/2004	KY	1.76	1	.7	M	11/05/2004	Pt brought back into clinic approx 1 hour after receiving vaccination. Child was listless, crying and unable to open eyes or hold head up. Childs legs and arms jerking. Pt was sweating.  911 was called and EMS arrived shortly thereafter.  Pt was transported to Hospital where it was discovered he had Rotovirus.				Y					Y	11/04/2004	11/04/2004	0	Stool positive for rotovirus	UNK	UNK		Afebrile, well at time of vaccination	History of febrile seizures			1						1	Crying; Dyskinesia; Eye disorder; Hyperhidrosis; Listless; Viral infection	FLU3~SANOFI PASTEUR~U01450AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228870	11/05/2004	AR	1.03	1	.0	M	11/05/2004	Patient with seizure activity around 1000am on the day following the administered the following vaccinations:  Hib, MMR, varicella, PVC, flu. Episode lasted approx 5 minutes per parents report and involved patients eyes rolling back, cessation of breathing, color change and limp.				Y					U	11/05/2004	11/06/2004	1		UNK	UNK	none	none	none			1						1	Apnoea; Convulsion; Eye movement disorder; Hypotonia; Skin discolouration	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~UNK~~~HIB (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1|VARCEL~MERCK & CO. INC.~~UNK~~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0228871	11/05/2004	OH	49.0	48		F	11/05/2004	flu mist administered at 11:30am and 3 1/2 hours later, became nauseaus.  Progressively got worse throughout the evening.  No appetite, difficulty falling asleep.  *I called 1-800-822-7967 yesterday as was listed on the information.  I spoke to a representative and she was not willing to take this information.  She said she was on a cell phone and there was too much static and she was having difficulty hearing me.  I was startled that there was no one available to take this information.  This indicates to me that many other potential adverse health events are not being reported and I would appreciate a response.  I plan on reporting this to the FDA and CDC along with the media.  Someone is getting paid a lot of money and not performing their job.  Your data must not be reliable.									Y	11/04/2004	11/04/2004	0		UNK	UNK	none	none	none			1						1	Anorexia; Insomnia; Nausea	FLUN3~MEDIMMUNE VACCINES, INC.~500337p~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0228874	11/05/2004	IN	0.67	0	.7	F	11/05/2004	11-4-04 at 1415 0.25ml of influenza vaccine administered Left VL IM as per CDC guidelines for 6months to 23 months of age. At 1435 after waiting 20 minutes, two hives were noted above injection site. Child less active than prior to vaccine administration.  Child taken into exam room and all clothes removed.  Hives noted on arms, trunk, back, neck, and behind Right ear.  Health officer notified per phone.  Orders received to administer epinephrine Sq per emergency protocols.  1446 Epi administered Sq left arm. Apical HR 128 beats/min. Resp. 44 breaths/min.  Resp. non-labored. Skin W/D and pink.  Child remaines alert and moving all extremeties.  Child wrapped in blanket.  1451 HR 144 beats/min. mouth/lips dusky and pale. Child placed in supine position on exam table. Some coughing and sneezing begining.  Began to administer PO Benadryl per pharmacist dosing advisement of 3/4 to one teaspoon. 1455 1ml benadryl given PO.  1459 1ml benadryl given PO. 1501 Had mother hold child to comfort.  Child crying.  Skin W/D.  Mouth pale. 1ml benadryl PO given. 1504 1ml benadryl given PO.  Color improved.  No paleness noted.  Lips pink. Hives remain.  No new hives noted. A total of 10mg benadryl PO given.  Advised mother that child should be taken to ER to be examined by a physician. 1510 called ER. Spoke with RN and updated.  1515 went with mother and child to ER.  Seen by ER physician.  Liquid baby prednisone given PO.  Instructed to see FMD 11-5-04.  Released from ER around 1615.  1700 mother returned child to ER D/T child becoming moist and clammy and skin temp. cold. Axillary temp 97 and 96.  Child observed in ER for one hour and then released home.  11-5-04 Child acting normal per mom. Seen by FMD on call.  Prescription for prednisone decreasing dosing schedule given.  Instructed to have child seen by FMD in one week.				Y					Y	11/04/2004	11/04/2004	0		UNK	UNK	None	None	None			1						1	Cold sweat; Cough; Crying; Cyanosis; Feeling cold; Pallor; Skin discolouration; Sneezing; Urticaria	FLU3~SANOFI PASTEUR~U1454AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228877	11/06/2004	MO	49.0			F	11/06/2004	PT BLEW HER NOSE IMMEDIATELY FOLLOWING ADMINISTRATION AND HAD BLOOD IN TISSUE.  NOSE DID NOT BLEED DURING REGULAR ACTIVITY, ONLY WHEN NOSE WAS BLOWN.									U	11/06/2004	11/06/2004	0		UNK	UNK						1						1	Epistaxis	FLUN3~MEDIMMUNE VACCINES, INC.~500333P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0228878	11/06/2004	CA	50.0	50		F	11/06/2004	Two days after vaccine developed body aches like bugs gnawing at muscles, low grade fever, weak could not get out of bed. Nausea and weight loss. Not eating.				Y					U	10/28/2004	10/30/2004	2		UNK	UNK	Oxycontin	Interstial Cystitis				1						1	Anorexia; Asthenia; Nausea; Pain; Pyrexia; Weight decreased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0228866	11/08/2004		47.0			F	11/05/2004	One episode voming about 40 hours after injection. 3 episodes loose stool about 40-42 hours after infectin. Mild transient dizziness, slight sweaty (transient). Follow up call in 6 hours. No additional symptoms; denies vomiting or diarrhea in last 6 hours. Notes slight and transient dizziness which has not interfered with her ability to work. Recheck at clinic if any problems.									U	11/03/2004	11/03/2004	0	NONE	UNK	UNK	NONE		NONE			1						2	Diarrhoea; Injection site pain; Nausea; Vomiting; Diarrhoea; Dizziness; Hyperhidrosis; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1445AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0228882	11/08/2004	FL	60.0	59		F	11/08/2004	Phone call received from patient today, who reports that 15 minutes after receiving the flu vaccine 11-05-04 she felt funny, burning all over, couldn't breathe, sweating, heart racing, nose itching, chest swollen. Reports difficulty breathing and tightness in chest all night, next morning face and eyes puffy , by Sunday, 11-07-04 all symptoms were gone.  Reports did not go to ER, but has talked to her MD office today.									Y	11/05/2004	11/05/2004	0	none	UNK	UNK		Emphysema	Allergies: PCN & Erythromycin Reports was struck by lightening July 2004.			1						1	Chest discomfort; Dyspnoea; Eye oedema; Face oedema; Feeling hot; Heart rate increased; Hyperhidrosis; Malaise; Pruritus	FLU3~SANOFI PASTEUR~U1500AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228883	11/08/2004	ID	77.0	77		F	11/08/2004	Pt presented to receive to routine adult vaccinations, flu and tetanus were indicated.  Gave patient flu vaccine and tetanus-diptheria vaccine after confirming no known allergies to vaccine and/or components.  Pt then remembered allergic to tetanus.				Y					Y	11/08/2004	11/08/2004	0		MIL	MIL						1						1	Hypersensitivity; Medication error	FLU3~SANOFI PASTEUR~1515AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U1347AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0228884	11/08/2004	CA	46.0	46		M	11/08/2004	Sore throat started within 4 hours.  Became very lethargic.  Became very congested within 12 hours.  Various aches and flu-like symptoms within 18 hours.  Had trouble staying hydrated.  Bedridden since the day after vaccine received.  Called doctor and was prescribed Amoxicillin (1000mg 2 x per day)and Sudafed and Tylenol 1000mg 2 x per day.  And drinking plenty of fluids.									N	11/04/2004	11/04/2004	0		UNK	UNK	Wellbutrin, Effexor, Prevacid	None	None			1						1	Dehydration; Influenza like illness; Lethargy; Nasal congestion; Pain; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~500337P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0228885	11/08/2004	CO	35.0	35		F	11/08/2004	3 days of an aching back & neck muscles, twitching leg muscles, diarrhea and sleepiness.  Treated with tylenol, Contact flu tablets.									Y	11/03/2004	11/03/2004	0		UNK	UNK	None	None	None			1						1	Back pain; Diarrhoea; Muscle twitching; Neck pain; Somnolence	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0228886	11/08/2004	TX	5.0	5		M	11/08/2004	Patient developed fever several hours after receiving vaccine. He was seen by his PCP on 10/29 and given antibiotics for a suspected sinus infection. Later that same day he developed seizures and was admitted to the hospital. A lumbar puncture was consistent with meningio encephalitis. He was intubated and placed on a ventilator on 10/31. Increased intracranial pressure required the placement of a ICP catheter on 11/2.  On 11/8 he was extubated and was responsive to painful stimuli. Discharge Summary received on 2/14/2005 states ADEM, aphasic, malnourished, meningitis, fever, bradycardia and nystagmus. As per annal follow up report: as of 12/06/2005 patient is permanently brain damaged, permanently mentally retarded and has seizures constantly.			Y					Y	N	10/27/2004	10/27/2004	0	MRI of the brain on 11/2/04 consistent with meningitis and encephalitis with progressing edema	UNK	UNK	NONE	NONE	Asthma			1						1	Anorexia; Aphasia; Bradycardia; Convulsion; Delirium; Encephalitis; Hypoxia; Infection; Intracranial pressure increased; Meningitis; Mental retardation severity unspecified; Nervous system disorder; Nystagmus; Oedema; Pyrexia; Aphasia; Bacterial infection; Brain oedema; CSF test abnormal; Convulsion; Encephalopathy; Movement disorder; Pain; Papilloedema; Pyrexia; Salivary hypersecretion; Sinusitis; White blood cell count increased	FLU3~SANOFI PASTEUR~UI458AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1458AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Disabling	Influenza
0228892	11/08/2004	ID	1.38	1	.4	F	11/08/2004	Fever under 100 degrees following administration of shot.  Over the next few days my daughter became wheezy, hoarse, had difficulty breathing and a fever.  Symptoms did not fade, so she was brought back to the doctor at around 1:00 p.m. on 11/5/04.  Doctor said to monitor, give a decongestant and give albuteral via nebulizer.  Conditions seemed to worsen over the weekend.  Brought her to the doctor again on Monday, 11/8/04 at 9:50 a.m. and was told she had pnemonia - unknown whether bacterial or viral.  The doctor decided to treat for bacterial and she prescribed Augmentin. Medical Records received on 1/3/2005 states pt experienced cough, rhinitis, and anorexia.			Y	Y					N	11/02/2004	11/04/2004	2		UNK	UNK	None	No	Patient has difficulty breathing when she has a cold or allergies.  She is considered too you to tell if asthmatic, but has family history of it.  Contracted RSV last in February of 2004 and was hospitalized for at least 3 days.	10/29/04 Emergency Room - suspected reaction to pertussis vaccine.~DTaP + HepB + IPV (Pediarix)~2~0.30~In Patient		1						1	Anorexia; Bacterial infection; Cough; Dysphonia; Dyspnoea; Pneumonia; Pyrexia; Rhinitis; Similar reaction on previous exposure to drug; Wheezing	FLUX~UNKNOWN MANUFACTURER~~1~~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0228894	11/08/2004	MI	75.0	74		F	11/02/2004	UTI.  Nurse follow up on 11/15/04 states: dysuria; acute cardiopulmonary arrest;   Death Certificate received which revealed COD as acute cardiopulmonary arrest, ischemic heart disease & COPD, all with chronic anemia and renal insufficiency as contributing factors.	Y	10/28/2004							N	10/27/2004	10/28/2004	1	UTI; COPD; Respiratory failure; Multiple Myeloma	PVT	PVT		UTI	COPD; Respiratory Failure; Multiple Myeloma; Anemia; pneumonia, chronic renal failure, encephalopathy, HBP, arrhythmias, hypercholesterolemia, seizure disorder, degenerative joint disease, osteoporosis, quadriparesis, and ischemic heart disease; renal insufficiency			1						1	Anaemia; Cardiac arrest; Dysuria; Lung disorder; Multiple myeloma; Myocardial ischaemia; Renal failure; Respiratory arrest; Respiratory failure; Urinary tract infection	FLU3~SANOFI PASTEUR~U1478AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0228895	11/08/2004	MI	65.0	64		M	11/02/2004	First visit to physician. Normal EKG.  Received ER medical records. Death Certificate received on 12/01/2004 states pt experienced arteriosclerotic heart disease.	Y	10/14/2004							N	10/13/2004			Chest pain; Malaise	PVT	PVT		Chest pain; Malaise	myocardial infarction, HBP, and nocturia.			1						1	Arteriosclerosis; Cardiac disorder; Chest pain; Malaise	FLU3~SANOFI PASTEUR~U1478AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0062P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Results in Death	Influenza
0228902	11/08/2004	AL	74.0	73		M	11/01/2004	Received flu shot 110/28 at 12:40 PM left arm; went home. Left to go to grocery store; returned home. Said I feel lifeless; right arm and leg felt weak. 10/29 woke up with flushed face, BP 170 (takes 2 antihypertensives each day). Wife called doctor; went to ER. CAT scan negative for CVA, agitate, loud; was admitted and sedated. Neurologist said it had to be the flu shot. Discharged 10/30; still drags right leg and right arm. Feels numb but can tell improving every day. Medical records received on 2/02/2005 states headache and adverse drug reaction. Follow up 01/26/05: He is still unusually jumpy and our doctor has prescribed muscle relaxers to help him still at night so that he can sleep. And I have had more colds this year, after the shot, than I 've have had. We hope that when spring gets her, the vaccine will have gone from his body.  Never, no more flu shots for us.  Per annual follow up Temporary paralized on left side and talking and acting crazy in hospital night and day. He is ok now. But it has taught us a lesson which is never take another flu shot.					Y	1			Y	10/28/2004	10/28/2004	0	Wife stated CAT scan negative for CVA.	PUB	PUB	Tricor; Verapamil; Avalid; Prevacid	Ulcer	None except for ulcer due to Naprosyn. Medical Record received on 2/02/2005 states esophogeal stricture, hypertension, hyperlipidemia, anxiety, vertigo and degenerative joint disease.		AL0425	1						1	Abnormal behaviour; Agitation; Difficulty in walking; Feeling abnormal; Flushing; Headache; Hemiparesis; Hemiplegia; Hypersensitivity; Difficulty in walking; Dyskinesia	FLU3~SANOFI PASTEUR~U1460AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0228903	11/08/2004	GA	6.0	5		F	11/02/2004	10/21/04 Sore throat, abdominal pain, low grade fever. 10/22/04 Sore throat, abdominal pain, vomiting, petechial rash on legs. 10/23/04 Joint pain, purpuric rash; hospitalized at hospital. Henoch-Schonlein Purpura. Also seen in ED on 10/22/04.				Y	Y	3			Y	10/20/2004	10/21/2004	1	CRP 4.2 mg/dl	PVT	PVT		10/21/04 stated had sore throat, stomach ache about a week.	NONE; Rash			1						1	Abdominal pain; Arthralgia; Henoch-Schonlein purpura; Petechiae; Pharyngolaryngeal pain; Purpura; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1489AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0228906	11/08/2004	DE	10.0	9		M	11/05/2004	Patient developed fever, conjuctivitis, periorbital edema on 11/4. He was seen 11/5 with diagnosis of LLL pneumonia and pansinusitis with most severe infections in sinuses. Patient admitted for oxygen, IV Rocephin and Albuterol. Discharged in 48 hours; Augmentin; Flonase; Allegra.					Y				Y	11/02/2004	11/04/2004	2	TC 11/2 Positive; CT Scan sinuses 11/5 positive for pan-sinusitis; 11/5 CXR positive for LLL pneumonia. Medical Record received on 1/3/2005 states pt did not experience sinusitis or pneumonia, but did have elevated WBC.	PVT	PVT	Zithromax	URI; Bronchitis. Medical Record received on 1/3/2005 states vomiting, cough, and pharyngitis.	NONE			1						1	Conjunctivitis; Infection; Leukocytosis; Lobar pneumonia; Periorbital oedema; Pyrexia; Sinusitis	FLUN3~MEDIMMUNE VACCINES, INC.~500335P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0228907	11/08/2004	NY	1.18	1	.2	M	11/08/2004	Patient received injection of flu vaccine on 11/4/04. That night developed fever to 102. Next day, febrile; responded to Tylenol. At 11/5 2 PM, gasped, became lethargic , temp to 104. Rushed by EMS to ER.					Y	2			Y	11/04/2004	11/05/2004	1	11/5 133/108/15, 7.9/19/0.3, 1026, l3 U, S, 0, K 12 W2, CSF-3W for 23.4gl-74, 11/5 11.8>11.9 (324 No 4 L 23), 11/7 CT of head, 11/6 EEG normal, 11/5 U/u, V/u, SCG/u-got 72 11/5 CXR normal	PVT	UNK	NONE	NONE	NONE			1						1	Dyspnoea; Lethargy; Pyrexia	FLU3~SANOFI PASTEUR~U1498AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0228912	11/08/2004	WI	1.0	1	.0	F	11/08/2004	Local erythema and redness and firmness at lower right thigh, at left thigh, and at lower left thigh. Fever the next day.									Y	10/11/2004	10/12/2004	1		PVT	UNK	Tylenol	Fever and tonsillitis the next day.	NONE			1						1	Injection site erythema; Injection site induration; Pyrexia	DTAP~SANOFI PASTEUR~C1996AA~4~~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1450AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0431N~3~~LL~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~A74404H~3~~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0228913	11/08/2004	PA	0.52	0	.5	F	11/04/2004	Rash started over band aid and spread all over body. Was with fever. Questionable allergic reaction or viral exanthem.									N	11/01/2004	11/02/2004	1	NONE	PVT	PUB	NONE	NONE				1						1	Hypersensitivity; Pyrexia; Rash	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A003AA~3~~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1439AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~495725~3~~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0228915	11/08/2004	AK	1.08	1	.1	F	11/04/2004	11/3/04 Lymphadenopathy, conjunctivitis, body rash (reddish pink).									U	10/22/2004	11/03/2004	12		OTH	PUB		NONE	Reoccurring otitis media			1						1	Conjunctivitis; Erythema; Lymphadenopathy; Rash	DTAP~GLAXOSMITHKLINE BIOLOGICALS~616A2~4~~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1414AA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~1050M~4~~RL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0105N~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A74404A~4~~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0228916	11/08/2004	NY	47.0	46		F	11/03/2004	Generalized malaise, body aches within a few hours; asthma attack. Induration at site followed by localized urticaria and chest tightness.				Y					Y	11/01/2004	11/01/2004	0	NONE	PVT	OTH	Zyrtec; Zoloft; Lorazepam; Flonase; Pulmicort	NONE	Asthma; Allergy			1						1	Asthma; Chest discomfort; Condition aggravated; Injection site induration; Malaise; Pain; Urticaria	FLU3~SANOFI PASTEUR~U1377AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0512P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0228917	11/08/2004	MO	67.0	67		F	11/03/2004	At 1:30 PM, developed itching, swelling at waist, crotch and under bra; took shower before itching. 8:00 PM, took Benadryl; slept until 4 AM. Awoke and had hive like areas on left side and back. 4:30 AM Took another Benadryl. No rash today; no itch.									Y	11/01/2004	11/01/2004	0		PUB	UNK	NONE	NONE	NONE			1						1	Pruritus; Swelling; Urticaria	FLU3~SANOFI PASTEUR~U1458AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228918	11/08/2004	MN	74.0	74		M	11/02/2004	Broke out in a rash that completely covered my body the day after the test.				Y					Y	10/20/2004	10/21/2004	1	Given Allegra by emergency doctor.	OTH	PUB	Wellbutrin; Lexapro; Prednisone	NONE	Myasthenia gravis since 1996			1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0228919	11/08/2004	VA	65.0	65		F	11/01/2004	Diffuse redness, 3 circular area at injection site (Pneumovax). Prednisone 10mg #30 2 PO BID three time; 2 PO in the morning, 1 PO for 3 days, 1 PO BID for 30 days, 1 PO QD.									Y	10/23/2004	11/01/2004	9	NONE	PVT	PVT	Plavix; Trazodone; Tylenol		No allergies; Hypertension; Hyperlipidemia			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U1500AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1201N~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0228920	11/08/2004	ME	78.0	77		F	11/01/2004	Injection site noted to be pink with about a quarter sized lump, tender to touch. No treatment. Site is fading, lump about size of dime 11/1/04.									Y	10/29/2004	10/31/2004	2	NONE	OTH	PVT	Bextra; Imdur; Vasotec; Metoprolol; B12; Catapress patch; Senna tabs.	NONE	Allergies: PCN; Arinza; Morphine; Cephalosporins; Basal ganglia stroke; HTN; Dementia; COPD; Anemia			1						1	Injection site erythema; Injection site mass; Tenderness	FLU3~SANOFI PASTEUR~U1446AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228921	11/08/2004	IA	1.02	1	.0	F	11/02/2004	Patient's mother called to see if she should receive her second dose because 48 hours after the first dose, she broke out in hives from head to toe.									Y	10/11/2004	10/13/2004	2	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1409BA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228922	11/08/2004	MN	65.0	65		F	11/01/2004	Shortness of breath; throat swelling (transient). Symptoms lasted 15 minutes; vitals stable. No medication administered.									Y	11/01/2004	11/01/2004	0		PVT	UNK		NONE	Breast cancer			1						1	Dyspnoea; Pharyngeal oedema	FLU3~SANOFI PASTEUR~U1425AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228923	11/08/2004	VT	3.0	3		M	11/01/2004	Fever in evening >100-101. Swelling injection site to elbow. Increased erythema and warmth injection site to most arm; slight tenderness.				Y					Y	10/28/2004	10/29/2004	1	NONE	PVT	PUB	Pulmicort; Albuterol	NONE	Asthma			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~U1439AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228924	11/08/2004	ME	71.0	70		F	11/01/2004	10/30/04 Injection site red, warm to touch, measures about a quarter diameter. On 10/31/04, patient was noted to be sleepy/tired, appetite poor, fever 100.8, 96, 20, 120/70. Site fading in color and size. Temp 99.8 on 11/01/04; remains tired with poor appetite. No treatment. 2/16/05 Discharge summary received which revealed COD to be CVA with PMH of profound Alzheimers, HTN, arthritis w/chronic pain & venous insufficiency.									N	10/28/2004	10/30/2004	2	NONE	OTH	PVT	Duragestic patch	NONE	Allergies: PCN, Sulfa, Iodine, Shellfish, Insect stings, Cephalosporins; HTN; Alzheimers; Vasculitis			1						1	Anorexia; Arthralgia; Cerebrovascular accident; Dementia; Fatigue; Hypertension; Injection site erythema; Injection site warmth; Polyarthritis; Pyrexia; Renal failure; Somnolence	FLU3~SANOFI PASTEUR~U1446AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228925	11/08/2004	ME	82.0	81		F	11/01/2004	Influenza virus vaccine Fluzone injection 0.5ml IM in left lateral deltoid. Noted in morning a 6cm in circumference, warm and firm in center, tender to touch. No treatments, Continues to fade.									Y	10/29/2004	10/31/2004	2	NONE	OTH	PVT	Aspirin; Metoprolol; Reglan; Ost-Cal; Mylicon; Aricept	NONE	Allergies; Dementia; Osteoarthritis; Diverticulitis; HTN			1						1	Injection site induration; Injection site warmth; Tenderness	FLU3~SANOFI PASTEUR~U1446AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228926	11/08/2004	ME	84.0	83		F	11/01/2004	Injection site with a quarter sized red lump with pink extending out about .5 inch, tender to touch, warm. 11/1/04  Fading, lump less than a dime size. Follow up: site reaction on left arm.									Y	10/28/2004	10/31/2004	3	NONE	OTH	PVT	Lasix; Zinc; Multivitamin; Tegretol; Zyprexa	NONE	Allergies; Dementia; Seizure			1						1	Injection site erythema; Injection site mass; Injection site warmth; Tenderness	FLU3~SANOFI PASTEUR~U1446AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228927	11/08/2004	ME	96.0	96		F	11/01/2004	Influenza virus vaccine Fluzone injection 0.5ml IM in left lateral deltoid muscle. On 10/30/2004 in AM was noted an 8cmx4cm red skin around injection site, hard and warm to touch with tenderness. No treatment, Tylenol offered for discomfort. Continues to fade.									Y	10/28/2004	10/30/2004	2	NONE	OTH	PVT	Lisinopril, Tenormin, ABC plus Senior vitamin, Glucosamine, Chronder ES	NONE	Dementia, HTN, Osteoarthritis			1						1	Feeling hot; Injection site erythema; Injection site mass; Tenderness	FLU3~SANOFI PASTEUR~U1446AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228928	11/08/2004	ME	87.0	86		F	11/01/2004	Injection site pink and warm to touch, about one inch in diameter. 11/1/04: faded, skin temp same over hand/ arm.									Y	10/28/2004	10/31/2004	3		UNK	PVT	Effexor, Tylenol, Aspirin	NONE	Allergies: PCN, Cephalosporins/ Alzheimer's, Arthritis, Ati Fib			1						1	Injection site reaction; Injection site warmth; Skin discolouration	FLU3~SANOFI PASTEUR~U1446AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228929	11/08/2004	PA	52.0	51		F	11/01/2004	Quarter sized raised lump around injection site. Warm to touch. Hard, red and swollen arm.									Y	10/26/2004	10/27/2004	1		PVT	PVT	Synthroda, Nexium, Albuterol inhaler, Valium	NONE	Codeine novocaine/ Hepatitis  C, GERD			1						1	Erythema; Injection site induration; Injection site mass; Injection site warmth; Swelling	FLU3~SANOFI PASTEUR~U1454AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~026AC~1~IM~RA~HEP B (FOREIGN)~1|HEPA~MERCK & CO. INC.~026AC~1~IM~RA~HEP A (VAQTA)~1	USA		Influenza
0228930	11/08/2004	MI	31.0	31		F	10/29/2004	Hives over entire body five days after shot administered. Took Hydroxyzine HCL 25 mg three time a day for two days, rash came back, have been taking Clarinex 5 mg one each night and Ranitidine 150 mg one each morning for one week.				Y					Y	10/15/2004	10/20/2004	5		PVT	UNK	Orthomicronor	NONE	NONE			1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~U1418AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228931	11/08/2004	NE	1.29	1	.3	M	11/02/2004	Pt developed 15-20  chicken pox lesions 14 days after vaccine given. Had fever 103 with this.									Y	10/15/2004	10/29/2004	14		PVT	PVT	NONE	NONE	NONE			1						1	Pyrexia; Rash vesicular	DTAP~SANOFI PASTEUR~C1698AA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1462AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE25BAA~4~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A74399D~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0072P~1~IM~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0228973	11/08/2004	PA	47.0	46		F		Within 1 hr of vaccine intense itching at site mild itching over body, pain at site, swelling of left arm from elbow up to shoulder, cellulitis at site redness, heat, pain, itching, 2x2 patch at site s/s lasted 3 days, each day decreasing in intensity.				Y					Y	10/07/2004	10/07/2004	0		PUB	UNK						1						1	Cellulitis; Feeling hot; Injection site erythema; Injection site oedema; Injection site pain; Injection site reaction; Pruritus; Rash	FLU3~SANOFI PASTEUR~U1454AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228974	11/08/2004	NE	48.0	47		F	11/05/2004	Immediately following admin of flu vaccine pt c/o feeling strange. Face flushed with temperature. Eye began to swell shut. Adrenaline .3mg given IM in thigh muscle. Much improved within 10 min states s/s decreased. Has had flu vaccine in past. No allergy to eggs.				Y					Y	11/05/2004	11/05/2004	0	NONE	PUB	PUB	Actose,  Evaridice, Glucophage	NONE	Diabetic			1						1	Eye oedema; Feeling abnormal; Flushing; Pyrexia	FLU3~SANOFI PASTEUR~U1458AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0242473	11/08/2004	NC	40.0	39		M	11/04/2004	Dry cough, congestion, nausea.									U	10/27/2004	11/01/2004	5	NONE	PVT	PVT		NONE	NONE		NC04113	1						2	Cough; Nasal congestion; Nausea	FLUN3~MEDIMMUNE VACCINES, INC.~500336P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0228987	11/09/2004	OH	0.82	0	.8	M	11/01/2004	Patient had micro-cephalic osteodysplastic primoidal dwarfism type I, a lethal genetic disorder with DNR/DNI status. Per parent request, vaccine given 10/18. Fever developed 10/19 PM. Other symptoms began 10/22, including vomiting, diarrhea, rash and continued fever. Seizure one time in afternoon. Dyspnea developed about 12 AM. 10/23 Patient transported to hospital; patient died about 0830 on 10/23. Medical record received on 11/22/2004 states pt experienced gastroenteritis and respiratory failure. Death Summary & ER Record received on 12/01/2004 states pt experienced Beach Disease and respiratory failure. Death Certificate received on 12/02/2004 states pt experienced respiratory failure, Majewski's micro-Cephalic osteodysplastic Dwarfism Type 1.	Y	10/23/2004	Y	Y					N	10/18/2004	10/19/2004	1	Stool for C diff toxin sent 10/22 (negative).	PVT	PVT	Zithromax suspension	Otitis Media.	Micro-cephalic osteodyplastic primoidal dwarfism Type I (lethal genetic disease).			1						1	Apnoea; Convulsion; Diarrhoea; Dwarfism; Dyspnoea; Gastroenteritis; Pyrexia; Rash; Vomiting	FLU3~SANOFI PASTEUR~U1489AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0228990	11/09/2004	NY	79.0	78		M	11/08/2004	From initial information received on 11/1/04 from the patient's spouse regarding an adverse event occurring, it was reported that a 78 year old male patient received a dose of FLUZONE, lot number U1512AA, administered IM in an unspecified site on 10/18/04. Two days later, the patient was hospitalized with sepsis, pneumonia, urinary tract infection and bleeding. Reportedly, the patient currently remains hospitalized. He is on a ventilator and is receiving blood transfusions and multiple antibiotics. At the time of vaccination, the patient also took Coumadin. Patient's pre-existing medical conditions include angina. His wife denied the patient having any illnesses at the time of vaccination. Reportedly, the patient received influenza vaccine annually with no reactions reported. He did not recover from these events.					Y				N	10/18/2004	10/20/2004	2		UNK	UNK			Patient's pre-existing medical conditions include a heart condition of angina. Wife denied the patient having any illnesses at the time of vaccination.		200403578	1						1	Haemorrhage urinary tract; Pneumonia; Sepsis; Urinary tract infection	FLU3~SANOFI PASTEUR~U1512AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0228999	11/09/2004	VA	27.0	27		M	10/31/2004	27 y/o 2 min developed non virulent pustules 9 days after immunization with smallpox.				Y					U	10/16/2004	10/27/2004	11		MIL	MIL	NONE	NONE	NONE			1						1	Rash pustular	ANTH~EMERGENT BIOSOLUTIONS~FAV083~1~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1501AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020072~1~ID~LA~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0229000	11/09/2004	VA	20.0	19		M	10/27/2004	Pt with submental abscess unknown at time of vaccination presented on 17th with Dx I and d and W Ancef started. 10mn after 2nd dose Ancef developed diffuse pustular rash, and itching, VSS, rash, resolving starting the 19th.									Y	10/15/2004	10/17/2004	2	CBC 101.7, 14.5/15/3 (19th) 8.4	MIL	MIL	Bicillin 1.2 m/o IM 10/11, Acel, WAB 19.98 x 2 doses	Submental abscess	Iodine, codeine, now (Ancef) new			1						1	Abscess; Pruritus; Rash pustular	ANTH~EMERGENT BIOSOLUTIONS~FAV081~1~~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1501AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020071~1~~LA~SMALLPOX (DRYVAX)~1	USA		Influenza
0229001	11/09/2004	VA	21.0	20		M	11/01/2004	Disseminated vaccinia Benadryl 25mg									Y	10/19/2004	10/29/2004	10	NONE	MIL	UNK		NONE	NONE			1						1	Cow pox	ANTH~EMERGENT BIOSOLUTIONS~FAV082~1~IM~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1501AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020072~1~ID~LA~SMALLPOX (DRYVAX)~1	USA		Influenza
0229002	11/09/2004	VA	20.0	20		M	10/31/2004	Small red bumps noticed on upper chest when pt was showering. This occurred one week after receiving small pox vaccine treated with Benadryl 25mg 1 PO QID.									Y	10/20/2004	10/31/2004	11	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Erythema; Rash	ANTH~EMERGENT BIOSOLUTIONS~FAV082~1~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1457AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020072~1~ID~LA~SMALLPOX (DRYVAX)~1	USA		Influenza
0229003	11/09/2004	VA				M	10/29/2004	22 y/o developed non virulent pustules 2 hrs to small pox vaccination rash developed around 9 days after inoculation				Y					U	10/17/2004	10/26/2004	9		MIL	MIL	Tylenol, Motrin	NONE	NONE			1						1	Rash pustular	ANTH~EMERGENT BIOSOLUTIONS~FAV082~1~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1457AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020072~1~ID~LA~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0229004	11/09/2004	VA	22.0	22		M	10/28/2004	Generalized vaccinia, non virulent pustules (erythematous rash on chest, neck, face). Benadryl and Tylenol given.				Y					Y	10/15/2004	10/28/2004	13	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Cow pox; Rash erythematous; Rash pustular	ANTH~EMERGENT BIOSOLUTIONS~FAV083~1~IM~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1501AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020071~1~~LA~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0229005	11/09/2004		20.0	20		M	10/28/2004	Erythematous rash/pox-like lesions on chest and back, generalized vaccinia. Pt given Benadryl and Tylenol.				Y					Y	10/19/2004	10/27/2004	8	NONE	MIL	UNK	NONE	NONE	Allergies PCN, Emycin, Clindamycin			1						1	Cow pox; Dermatitis bullous; Rash erythematous	ANTH~EMERGENT BIOSOLUTIONS~FAV082~1~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1457AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020072~1~ID~LA~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0229006	11/09/2004	CA	4.0	4		M	11/04/2004	Swelling, redness, mild tenderness left upper arm 1 day after injection little itchy worse next day 2.									Y	11/01/2004	11/02/2004	1	NONE	PVT	PVT			Asthma			1						1	Injection site erythema; Injection site oedema; Pruritus; Tenderness	DTAP~SANOFI PASTEUR~C1527AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1505AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X03672~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0181N~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0229007	11/09/2004	TX	3.0	3		M	11/05/2004	Left thigh at site of influenza vaccine 4x6 erythema and induration. Not painful. Afebrile.				Y					Y	11/03/2004	11/04/2004	1		PVT	PVT	NONE	NONE	ABO incompatibility at birth. allergic to peanuts.			1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U1458AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229008	11/09/2004	NY	51.0	51		F		SOB, Bronchospasms, Respiratory distress, Hives, Seen at Emergency care ctr given: Vaponepaline 0.5cc, Prednisone 50mg PO, Caperidioxe x 5 days.				Y					Y	10/29/2004	10/29/2004	0		PUB	UNK	Flovent, Xipenox		Asthma, Sulfa meds			1						1	Bronchospasm; Dyspnoea; Respiratory distress; Urticaria	FLU3~SANOFI PASTEUR~U1478AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229010	11/09/2004	CA	14.0	13		F	11/08/2004	Child presented with stomach problems, dizzy, weak. Mom called doctor who recommended Robitussin and continue using inhalers. On Tuesday child was seen by Dr who mentioned right lung was infected. Diagnosed with pneumonia. Child started taking Prednisone, erythromycin and albuterol through inhaler machine. Today child was throwing up.				Y					N	10/28/2004	10/30/2004	2		PVT	PVT	Inhaler	NONE	Asthma, allergies, jaundice at birth, born premature			1						1	Abdominal discomfort; Asthenia; Dizziness; Infection; Pneumonia; Vomiting	DTP~UNKNOWN MANUFACTURER~~UNK~~RA~DTP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~RA~HEP A (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0229011	11/09/2004	WA	32.0	32		F	11/04/2004	Some wheezing when exhaling, diarrhea, nauseous (w/o vomiting). No rx-all symptoms resolved in <24 hours.									Y	11/02/2004	11/03/2004	1	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Diarrhoea; Nausea; Wheezing	FLU3~SANOFI PASTEUR~U1476AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229012	11/09/2004	TN	1.5			M	10/28/2004	Swelling of thighs where vaccines administered									Y				NONE	PVT	PVT		NONE	NONE			1						1	Injection site oedema	DTAPH~SANOFI PASTEUR~UE414AA~4~IM~LL~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~U1389AB~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~AB96594~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0229013	11/09/2004	FL	1.34	1	.3	F	11/03/2004	Later in evening, patient developed rash on cheeks and then hives. Had  intermitant hives x 24-36.				Y					Y	10/19/2004	10/19/2004	0	NONE	PVT	UNK		NONE				1						1	Rash; Urticaria	DTAP~SANOFI PASTEUR~U1300CB~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1463AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE144AA~4~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A57556F~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0229014	11/09/2004	NH	10.0	10		M	11/03/2004	Pt. had a fever of 101.5F around 24 hours after vaccine around 48 hour vaccine, the arm left where he received the vaccine became hard and warm to the touch, it was hard from his armpit down to his elbow. It was red as well. It took around 48-72 to completely go away.									Y	10/20/2004	10/22/2004	2		PVT	UNK	Rapamine, Protonix, Calcitriol,					1						1	Erythema; Feeling hot; Injection site induration; Pyrexia	FLU3~SANOFI PASTEUR~U1409BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229015	11/09/2004	LA	0.8	0	.8	F	11/03/2004	Approximately 2 hours after receiving flu vaccine. Patient's lower torso and extremities were covered with whelps. No respiratory problems. Benadryl recommended.  Phone call to parent on 11/3/04. Whelps resolved.				Y					Y	11/02/2004	11/02/2004	0	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1391AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229016	11/09/2004	NY	44.0	43		F	11/05/2004	Right upper arm swelling, ecchymosis, erythema commencing 24 hours after shot, by 48 hours, 3.5x3.5 inch area of erythema, slight edema, slight ecchymosis, warm to touch; by 72 hours erythema diminished.									Y	11/02/2004	11/03/2004	1	NONE	UNK	PVT	Sudafed	NONE	NONE			1						1	Ecchymosis; Erythema; Feeling hot; Oedema; Swelling	FLU3~SANOFI PASTEUR~U1501AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229017	11/09/2004	CA	5.0	5		M	11/04/2004	10cm zone of induration and erythema around vaccination site.									U	11/02/2004	11/03/2004	1		PVT	UNK	NONE	Upper respiratory infection with bilateral middle ear effusions.	NONE			1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U1451AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229018	11/09/2004	SC	4.0	4		F	11/05/2004	7cm x 12 cm redness and induration at left deltoid. Patient complains of itching. Treatment: Augmentin ES 1 tsp bid x 10 days. Warm compress , antihistamine.									U	11/03/2004	11/03/2004	0		UNK	UNK						1						1	Erythema; Injection site induration; Pruritus	DTAP~GLAXOSMITHKLINE BIOLOGICALS~2614C9~5~~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1418AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1189~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0771P~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0229019	11/09/2004	WI	0.63	0	.6	M	10/28/2004	Received Influenza vaccine at 6:55 pm. 10/26/04 and began vomiting again within 15 minutes of receiving vaccine while still at clinic. Seen and evaluated by doctor that evening 10/26.  Discharged home with parents. Continued to vomit x 2 on 10/27 and has vomited x 3 on 10/28/2004 at time of filing report. Still vomiting as of 10/28/2004.  Follow up on 11/12/04 states: Note mother had egg allergy but child has never had eggs. Vomiting started in 15 minutes post vaccination and persisted 72 hours. Prescribed clear fluids, small amounts.				Y					N	10/26/2004	10/26/2004	0	NONE	PVT	PVT	NONE	NONE	Left undescended testicle			1						1	Vomiting	FLU3~SANOFI PASTEUR~U1425~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229020	11/09/2004	NJ	10.0	10		F	10/30/2004	Increased seizure activity. Mom states patient developed seizure approximately 1 hour after influenza vaccine injection was administered.									Y	10/11/2004	10/11/2004	0		PVT	UNK		Sinusitis, Chronic Cough, Rx: antibiotics	Rett's Syndrome, Seizure disorder			1						1	Convulsion	FLU3~SANOFI PASTEUR~U12B9AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229021	11/09/2004	VA	18.0	18		F	10/30/2004	Vaccine given at 11:15 on 10/16/2004. At 14:35 patient presents to the nursing office with hives. Benadryl 50 mg was given and ineffective. Prednisone 60 mg was given at 15:20 with no effect. Referred to the ER had given Prednisone 20 mg qd x 4 days. Medical Records received on 12/07/2004 states wheezing.				Y					Y	10/16/2004	10/16/2004	0		PVT	PUB	Strathee, Fibil ml, Colace, Triocinol cream.	NONE	Generalized reflex disorder. Medical Records received on 12/07/2004 stets seasonal allergies.			1						1	Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U1499AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229022	11/09/2004	NC	1.38	1	.4	M	10/25/2004	Large cellulitis > 1 week at DTaP site. Probably not an allergic reaction.				Y					Y	10/07/2004	10/17/2004	10		PVT	UNK	NONE					1						1	Cellulitis; Injection site reaction	DTAP~SANOFI PASTEUR~U1307CA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~41417AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~1095N~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0276P~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0229023	11/09/2004	AL	6.0	6		M	11/01/2004	3x3 red area on right thigh, slight swelling, heat									Y	10/29/2004	10/30/2004	1		PVT	PVT		NONE	Asthma			1						1	Feeling hot; Swelling	FLU3~SANOFI PASTEUR~U1500AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229025	11/09/2004	NJ	1.5	1	.5	F	11/02/2004	Patient received influenza vaccine and started on Amoxicillin 10/24/04. 4 days later diagnosed with erythema multiforme-minor. No treatment needed.									Y	10/22/2004	10/28/2004	6		PVT	PVT	Amoxicillin	Bilateral otitis media				1						1	Erythema multiforme	FLU3~SANOFI PASTEUR~U1411AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229026	11/09/2004	OR	80.0	80		F	10/22/2004	Flu shot reaction: sore muscles right side of back. Developed when exposed to cold. Was not feeling well a day or so after receiving the shot. Finally subsided on 10/23/04.									U	10/01/2004	10/02/2004	1		UNK	UNK	Nexium 40mg, Tylenol, Premarin	NONE	NONE			1						1	Malaise; Myalgia	FLU3~SANOFI PASTEUR~U1440AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229027	11/09/2004	MI	36.0	36		F	11/04/2004	Instructions for flumist doesn't state to push hard and quickly for mist to occur. I pushed syringe with normal force and immunization stayed in liquid form. Next day patient showed flu symptoms such as congestion and cough. Was not seen for having flu-like symptoms.									Y	10/26/2004	10/27/2004	1		PUB	PVT	NONE	NONE	NONE			1						1	Cough; Nasal congestion	FLUN3~MEDIMMUNE VACCINES, INC.~500338P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229062	11/09/2004	KS	71.0	70		F	11/09/2004	Left upper arm swollen, red, hot , painful. Prednisone given.				Y					Y	10/28/2004	10/29/2004	1	CBC done	PVT	PVT	Toprol XL	NONE	NONE			1						1	Erythema; Feeling hot; Pain; Swelling	FLU3~SANOFI PASTEUR~U1451AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0228902	11/10/2004	AL	73.0	73		M	11/04/2004	Received shot about 12:40 on 10/28/04 and went to the store; feeling fine. When I returned home, I began dragging my right foot and jerking my right arm. Blood pressure went way on.				Y	Y	2			Y	10/28/2004	10/28/2004	0	They did CT Scan to see if he had a stroke, but doctor says it was clear.	PUB	PUB	Verapril; Avalide	NONE	NONE			1						2	Abnormal behaviour; Agitation; Difficulty in walking; Feeling abnormal; Flushing; Headache; Hemiparesis; Hemiplegia; Hypersensitivity; Difficulty in walking; Dyskinesia	FLU3~SANOFI PASTEUR~U1460AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0229067	11/10/2004	WA	39.0	38		F	11/10/2004	Swelling, itching, painful, redness at injection site for 2 weeks and has not subsided. Reported to clinic 11/1/04. Referred to PMD and was placed on antibiotics.				Y					Y	10/09/2004	10/20/2004	11		UNK	UNK		none	none			1						1	Injection site erythema; Injection site hypersensitivity; Injection site pain; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U1500AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229069	11/10/2004	TX	37.0	36		F	11/10/2004	Injection @ 12 noon on 10/6/04.  12 hours later: Headaches, Chills, Shakes, Fever 102, Aches/Pains, Chest Discomfort, Extreme Tiredness.  Lasted for about 24 hours, then fine.									Y	10/06/2004	10/07/2004	1		UNK	UNK	Levothyroxine 75mcg	None	Allergy to Tetracyclines (Rxn to Minocycline specifically)			1						1	Chest discomfort; Chills; Fatigue; Headache; Pain; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U1447aa~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229070	11/10/2004	MS	62.0	62		F	11/10/2004	Received flu vaccine at about 8:00a.m.  Chills started at about 2 to 3 p.m.  Fever at about 5p.m.  Reaching 101.6 by 8p.m.  Fever continued thru the night; breaking about 6a.m. on the 10th.  I first began taking asprin.   Talked with my Dr. and he recommended Tylenol every four hrs.  I feel very weak today but feel like I will continue to improve.									Y	11/09/2004	11/09/2004	0		UNK	UNK						1						1	Asthenia; Chills; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0229071	11/10/2004	FL	1.36	1	.4	F	11/10/2004	11x8cm SWELLING ON RIGHT THIGH. MOM REQUESTED TO GIVE ALL 3 VACCINES (DTAP, PREVNAR & FLU) ON THE SAME THIGH.  MEDICATION & TREATMENT STARTED ON NOV. 10, 2004.				Y					U	11/08/2004	11/09/2004	1		UNK	UNK	NONE	NONE	NONE			1						1	Injection site swelling	DTAP~SANOFI PASTEUR~C2044AA~4~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~W416AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A74398B~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0229076	11/10/2004	MI	86.0	86		M	11/08/2004	From initial information received on 11/3/04 from the patient's daughter, it was reported that an 86 year old male patient received a FLUZONE vaccination, lot number unknown, administered in the left arm on 10/7/04. Reportedly six days later on 10/13/04, the patient developed bleeding under the skin from his left shoulder to wrist with blotches to chest, back down to his waist. He also developed swelling of the entire left arm with persistent pain. The same day the patient experienced these adverse events he had received chemotherapy for lymphoma. He was admitted to the hospital for four days. He had not been hospitalized for several weeks. The reporter was told by the patient's oncologist that he may expect bleeding episodes from the chemotherapy. The patient's oncologist does not feel the adverse events are vaccine related. The patient's recovery status is currently reported as not recovered.					Y	4			N	10/07/2004	10/13/2004	6	Blood work done at hospital; results not reported. An ultrasound was negative for hematoma.	OTH	UNK	Hormone injections; Vicodin; Prednisone; Darvocet; Chemotherapy		The patient had no pre-existing allergies, however does have a medical history of lymphoma.		200403604	1						1	Haemorrhage; Oedema peripheral; Pain; Rash macular	FLU3~SANOFI PASTEUR~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0229081	11/10/2004	KS		60		F	11/03/2004	Patient states had pneumonia shot on 10/28/04. Later that day developed redness, swelling, surrounding area where shot was given. Was told to take Tylenol and apply ice. Lasted for six days.									Y	10/28/2004	10/28/2004	0		PVT	PVT	Lasix-KCL-glucophage Sarafam. Zyrtec-Diovan-Lipitor-ASA	acute sinusitis	perocet-Type II Diabetes, HTN, OSA, Dyslipidemia			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U1417AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0987N~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0229082	11/10/2004	CA	89.0	88		M	11/04/2004	Daughter phoned to say dad experiencing dizziness . Headache, hoarseness shortly after immunization, but didn't say anything at past history									U	11/04/2004	11/04/2004	0		PUB	PUB	Mexican tonic, ST5, Yam Green	Prostate Cancer	PCN, Erythromycin			1						1	Dizziness; Dysphonia; Headache	FLU3~SANOFI PASTEUR~U1519AB~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229083	11/10/2004	CA	85.0	84		M	11/02/2004	Severe diffuse overall rash entire body. Mac-Pap.				Y					N	10/16/2004	10/18/2004	2	NONE	PVT	UNK	Predsine, Prozosin, Finotiche, Molprolor	Chronic condition. No acute others	IVP dye			1						1	Rash maculo-papular	FLU3~SANOFI PASTEUR~U1452AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229085	11/10/2004	IN	61.0	60		M	10/21/2004	Rash on right side of body. Itching and pus filled blisters under right breast area and upper right arm.									U	10/21/2004	10/22/2004	1	referred to MD	UNK	PVT			Diabetes, HBP			1						1	Blister; Pruritus; Rash; Rash pustular	FLU3~SANOFI PASTEUR~U1447AA~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229086	11/10/2004	NC	8.0	7		M	11/02/2004	10/22/2004: swelling in left arm area 4 diameter. Swelling wasgone by 10/23. ON 10/22 about 11PM also ran fever 103 till 10/25. Saw his cardiologist due to fever on 10/25. MD felt it may not be related to shots.				Y					Y	10/21/2004	10/22/2004	1	NONE	PUB	PUB	Nutropin, Digoxin, Lasix, Liaisopril	NONE			NC04115	1						1	Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U1417AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0865N~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0229087	11/10/2004	NC	1.3	1	.3	F	11/01/2004	On 7:30 PM 10/21 after flu shot, noticed fine rash on stomach. By 10/22, rash was all over with hive like areas on left wrist. Not talked with MD over the phone. Started child on Benadryl. Rash better on Saturday and gone on Sunday 10/24. MD didn't feel related to flu shot.									Y	10/21/2004	10/21/2004	0	NONE	PUB	PUB		Fever	NKA		NC04117	1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~U1391AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229088	11/10/2004	GA	50.0	49		F	09/30/2004	Patient received influenza (front left deltoid) and Pneumovax (back left) per her request. Patient reported swelling from back of arm to her elbow. Shots received Tuesday; symptoms began Wednesday. Was somewhat better Thursday although still some redness and heat down the back of the arm.									Y	09/28/2004	09/29/2004	1		OTH	OTH		NONE				1						1	Erythema; Feeling hot; Swelling	FLU3~SANOFI PASTEUR~U1448AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0740N~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0229089	11/10/2004	VA	66.0	66		M	11/08/2004	Patient stated noted tenderness and itching at injection site on evening after receiving influenza injection. 48 hours later, noticed 4 x 9 rash/redness in upper arm at injection site.				Y					Y	11/03/2004	11/03/2004	0		UNK	UNK		NONE	NONE			1						1	Injection site erythema; Injection site hypersensitivity; Injection site pain; Injection site rash; Pruritus	FLU3~SANOFI PASTEUR~U1459AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229090	11/10/2004	NY	73.0	73		F	11/04/2004	Chills/nausea; onset 2 hours post vaccine. Muscle aches during night; 2 days later neck muscles and those surrounding eyes. Neuralgia roots of hair. Low grade fever (99.6) when Tylenol not in effect. Continues through today 11/4. Eye/neck muscles still painful; muscle involvement continues to this day.									Y	10/19/2004	10/19/2004	0		OTH	UNK		NONE	NONE			1						1	Chills; Eye pain; Myalgia; Nausea; Neuralgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0229091	11/10/2004	MD	53.0			F		Swollen lymph nodes in axilla; same side as injection with pain, induration with distinct margin at injection site. No erythema.									Y					UNK	UNK		NONE	NONE			1						1	Injection site induration; Injection site pain; Lymphadenopathy	FLU3~SANOFI PASTEUR~U1377AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229074	11/11/2004	CA	64.0			M	11/11/2004	Soreness in arm near injection site. Went to bed immediately after shot (felt weak and a little disoriented shortly after injection). Slept (unconscious from 0900 to noon); had a full nite sleep 1200-0900 the nite before) and awoke a little groggy. Called in sick to work at noon. Went back to bed and slept for 4 more hrs. Awoke feeling a little better but rested the rest of the day and got a good nites sleep. Low blood sugar (Diabetic) may account for some symptoms. Fealt Ok the following day and went to work.									U					UNK	UNK		Diabetic				1						1	Asthenia; Condition aggravated; Disorientation; Injection site pain; Somnolence	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0229103	11/11/2004	ND	4.0	3		M	11/11/2004	10 days after immunization, developed symptoms of bowel obstruction, including vomiting, abdominal distension, hypoglycemia, and profound dehydration.  Hospitalized, fluid resuscitated, and transferred to tertiary care hospital with diagnosis of enterocolitis.  Another student at same facility received same vaccine (different bottle) on the same day, and also developed bowel obstruction within hours.  (separate report filed this date)			Y	Y	Y	6			U	10/25/2004	11/05/2004	11	Serum glucose 28, xrays showed obstructive pattern, hyponatremic, hypochloremic dehydration	UNK	UNK		Waardenburg syndrome, s/p subtotal colectomy and ileoanal pull-through 8/04	sensorineural deafness developmental delay peripheral neuropathy food allergies, topical gentamycin allergy			1						1	Abdominal distension; Dehydration; Enterocolitis; Hypochloraemia; Hypoglycaemia; Hyponatraemia; Intestinal obstruction; Vomiting	FLU3~SANOFI PASTEUR~41438AA~4~ID~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0229104	11/11/2004	ND	19.0	18		M	11/11/2004	10 days after immunization, developed acute small bowel obstruction with perforation. Another student at same facility received same vaccine (different bottle) on the same day, and also developed bowel obstruction within hours.  (separate report filed this date) Discharge Summary received on 1/25/2005 states pt experienced distended abdomen and perforated viscus.			Y	Y	Y				N	10/25/2004	11/05/2004	11	massively dilated small bowel with free air and pneumatosis coli	UNK	UNK	trileptal, topamax, valium, baclofen, MOM	none	cerebral palsy, seizure disorder, history of multiple abdominal surgeries, profound mental retardation			1						1	Abdominal distension; Intestinal obstruction; Intestinal perforation; Laboratory test abnormal	FLU3~SANOFI PASTEUR~41496aa~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0229106	11/11/2004	MO	36.0	35		F	11/11/2004	Vaccine was administered at 10:45 a.m.; patient began experiencing blotchy rash, itching and swelling to face/hands at approximately 11:45 a.m. Evaluated and treated in Emergency Department from approximately 12:38 p.m. until 15:02. Received IV fluids, 125mg solumedrol IV, pepcid 20mg IV, 25mg vistaril IM, prednisone 50mg p.o. and benadryl 50 mg. p.o.				Y					Y	10/14/2004	10/14/2004	0	None performed	UNK	UNK	None		Allergy to codeine; no other specific illnesses and/or medical conditions.			1						1	Face oedema; Oedema peripheral; Pruritus; Rash; Rash macular	FLU3~SANOFI PASTEUR~U144999~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229109	11/11/2004	AL	67.0	67		M	11/11/2004	High fever (102), chills that lasted several hours, hard shakes, about 13 hours after took FLU shot, 400 mg Ibuprofen.									Y	11/10/2004	11/10/2004	0		MIL	UNK						1						1	Chills; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0229115	11/11/2004	TN	12.0	11		M	11/10/2004	SC fullness in both arm (11/09/04) 11/10/04 redness 2x7cm on both arms, minimal periorbital eczema. Mom treated with Benadryl. Resp Rate 28mm. Tx with Zyrtec, Prolex PD, and Steroids added.				Y					Y	11/08/2004	11/08/2004	0		PVT	PVT	Advair, Singulair, Flonase		Asthma			1						1	Eczema; Injection site erythema	FLU3~SANOFI PASTEUR~U1380AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0257N~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~AVENTIS PASTEUR~U1020AA~6~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0229116	11/11/2004	NC	29.0	29		F	11/10/2004	Flu Like Symptoms, Fever, sore throat, aches, fatigue, runny nose, sneezing. Took OTC meds, missed 1 day of work, Did not see medical treatment.									U	11/08/2004	11/08/2004	0		OTH	PVT		NONE	NONE			1						1	Fatigue; Influenza like illness; Myalgia; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~500336P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229117	11/11/2004	WI	66.0	65		M	11/08/2004	11/08/04 PC: per wife, redness, warmth, at site 4 hours later, Thurs (11/4) night: fever, chills, shaky episodes,  Friday and Saturday: swollen, fiery red, Sunday (11/7): not as fiery red, still warm, still with occasional chills, shaky episodes. Called HCP: advised ER: Dx Cellulitis Rx Keflex. No fever in ER. Today temp 101. To see HCP.				Y					U	11/04/2004	11/04/2004	0	11/07/04 CBC Blood cultures	PUB	PVT	Imitrex	NONE	Hx Arthritis, Bleeding ulcer, Migraines		WI0415	1						1	Cellulitis; Chills; Feeling hot; Injection site erythema; Injection site oedema; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U1504AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0664N~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0229118	11/11/2004	WI	72.0	72		F	11/01/2004	Describes reaction of welt (redness and warmth) at previous vaccine site (in 2000). Then received half doses at HCP this year: Vaccine administered 10/28/04 at left arm. Denies any mark/irritation of left arm. C/o itching and redness, chest and neck about 4 hours later and blotchy red areas (itchy) on both legs 10/29 less red today 11/01/04.									Y	10/28/2004	10/28/2004	0		PUB	PVT			Previous welt at previous flu vaccine site.			1						1	Injection site erythema; Pruritus; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~41504AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229119	11/11/2004	WI	73.0	73		F	11/01/2004	11/1/04 called on 10/26/04 vaccine developed hive on lower arms, wrists, hands on both extremities and on buttocks. Advised Benadryl 10/30/04. Recalls one previous episode of hives on one cheek not related vaccines or illness. Symptoms resolving. 11/2/04 PC: F/U rash, 911 call tongue swelling at 10PM. Rx Prednisone Rc'd Snadapril, 11/8/04 PC will see HCP, no BP noted: one welt on wrist today, might be from old wrist watch (itching) or adornment. Suggest could be stress related: mother in law moving. Lab work ER.									U	10/26/2004	10/27/2004	1		PUB	UNK	Enalapril, Azathioprine, Vitamin, Calcium, Plavix, Thyroxine.	Ortho Surg 10/13/04	Rheumatoid Arthritis; Allergy to pain meds		WI0418	1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1504AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229120	11/11/2004	WI	47.0	47		F	10/18/2004	Client states she noted an exacerbation of asthma. Had SOB and Asthma medication did not work as well. Client needed to take an increase in asthma medication. Needed Albuterol inhaler 3-4 x a day 10/15, 10/16 and 10/17. Improved later 10/17.									Y	10/14/2004	10/15/2004	1		PUB	PUB		NONE	Hx Asthma		WI0419	1						1	Asthma; Condition aggravated; Dyspnoea	FLU3~SANOFI PASTEUR~U1476AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228429	11/12/2004	NY	63.0	63		M		Headache started 10/06 still present									N	10/06/2004	10/06/2004	0	CT Brain; Cspin x ray: pending	PUB	PUB			History of DM, Pontine stroke, Paget			1						2	Headache; Pain; Headache	FLU3~SANOFI PASTEUR~U140913A~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1409BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0229144	11/12/2004	GA	2.0	2	.2	M	10/24/2004	DTaP and flu given on Friday. Yesterday small, red areas. Lateral side on left leg. This AM larger than lemon (red knot). Now at office (3:30) size of baseball, very red. 103 this AM on Motrin/Tylenol. Last dose Motrin/Benadryl at 2:00. Temperature now 99.7 rectal.					Y	1			Y	10/22/2004	10/23/2004	1	CBC	PVT	PVT	Rocephin; Reglan; Zyrtec; Singulair; Feyth 20mg;	Otitis Media;	Immune suppressed;			1						1	Injection site erythema; Injection site mass; Pyrexia	DTAP~SANOFI PASTEUR~C2044AA~4~~LL~DTAP (DAPTACEL)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0229148	11/12/2004	ME	71.0	70		M	11/10/2004	Injection site rt arm inflamed/tender. Resolved without medical interaction. Tylenol/cool compresses only.				Y					Y	11/08/2004	11/08/2004	0	NONE; Pt examined by MD	PVT	PVT		NONE	Nortic and mitral valve replacement: mesenteric ischemia			1						1	Injection site inflammation; Tenderness	FLU3~SANOFI PASTEUR~U1497AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577P~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0229149	11/12/2004	AL	68.0	67		F	11/01/2004	10/31/04: hives started in hair and progressed to cover her whole body.				Y					N	10/29/2004	10/31/2004	2		PUB	PUB	Diovan, Glucosamine, Condritin, Cozaar		Hypertension, Arthritis		AL0426	1						1	Urticaria	FLU3~SANOFI PASTEUR~U1456AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229150	11/12/2004	WI	66.0	65		U		Probable cellulitis at site of influenza injection.									U	11/01/2004			NONE	PVT	PVT						1						1	Cellulitis; Injection site reaction	FLU3~SANOFI PASTEUR~U1438AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0740N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0229151	11/12/2004	ID	0.55	0	.6	M	10/20/2004	Mom states that child has hives all over his body red in color and warm to touch.									Y	10/19/2004	10/20/2004	1		PUB	PUB	Motrin	Cold			ID04053	1						1	Feeling hot; Rash erythematous; Urticaria	FLU3~SANOFI PASTEUR~U1392AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229152	11/12/2004	MD	30.0	30		F	11/10/2004	Began to have severe aching pain in left shoulder, shoulder blade and neck approximately 2 hours after receiving vaccines.									Y	11/09/2004	11/09/2004	0		UNK	UNK	NONE					1						1	Myalgia; Neck pain; Pain	FLU3~SANOFI PASTEUR~U1537AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229153	11/12/2004	CA	6.0	6		F	11/07/2004	75 hours after vaccine , lower part of upper arm very swollen and red (blanchable through and non tender, also itchy); phone call 11/7/04, recovering well per day (mom not home)									U	11/01/2004	11/02/2004	1		UNK	UNK		NONE	Asthma			1						1	Erythema; Injection site discolouration; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U1463AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229154	11/12/2004	NC	1.29	1	.3	F	11/08/2004	2x2 cm swelling in both thighs at injection site.									Y	11/04/2004	11/04/2004	0		PVT	PUB		NONE	NONE			1						1	Injection site swelling	DTAP~SANOFI PASTEUR~U1316DA~4~~LL~DTAP (TRIPEDIA)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~SANOFI PASTEUR~E194AA~4~~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A57556~4~~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0648P~1~~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0229155	11/12/2004	WI	3.0	2	.8	F	11/08/2004	Vaccine (flu) given 11/3/04. Fever 102.4. 11/5/04, 11/6/04 and 11/7/04. Hives developed 11/6/04 begain on trunk then neck and face and then down legs and arms. Doesn't seem to be itchy . Hives continue to be present 11/8/04. No nasal drainage or other cold-like symptoms. Did not take to MD.									Y	11/03/2004	11/05/2004	2	NONE	PUB	PUB		NONE	NONE			1						1	Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U1389AB~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229156	11/12/2004	OH	0.71	0	.7	F	11/04/2004	Immunization red, swollen, hot 2 diameter around injection site left leg. Observed for 30 min. Received 0.5tsp Benadryl Elixir.									Y	11/02/2004	11/02/2004	0		PVT	PVT						1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1512AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1038~3~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1188N~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0229157	11/12/2004	IA	77.0	77		F	11/05/2004	Patient called  on 11/4/04 and reported that her arm got red and hot right away after she got shot. on 11/2 stated her arm hurt. On 11/3 she said she has sore throat and runny nose. She went to her physician who told her it was from the shot. After she called on 33/4: we told her to put cold packs on arm.				Y					Y	11/01/2004	11/01/2004	0		PUB	PVT	Synthroid, Dioban, Fosamax, Prothmix, ASA, Cosamide, Vitamin C, Tums	NONE	Penicillin, Sulfa, Codeine, Viox; Diabetes			1						1	Erythema; Injection site warmth; Pain; Pharyngolaryngeal pain; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1479AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229158	11/12/2004	PA	3.0	3		M	11/08/2004	11/1: received flu vaccine. 11/2 developed swelling/ redness of upper extremity proximal to elbow. 11/3 seen with significant swelling proximal upper extremity , erythema and vesicular rash to elbow. Afebrile. Later 11/3 admitted with worsening rash/ swelling and fever to 101. Treated for allergic reaction and cellulitis with IV abx and Benadryl. Slowly improved and was discharged on 11/6. Medical Records received on 1/20/2005 states pt experienced agitation.									Y	11/01/2004	11/02/2004	1	wound culture negative CBC. Blood culture negative.	PVT	PVT	NONE	URI	Recurrent OM: BMT's 5/02, RAD. Medical Records received on 1/20/2005 states prematurity and liver disease.			1						1	Agitation; Cellulitis; Erythema; Hypersensitivity; Pyrexia; Rash vesicular; Swelling	FLU3~SANOFI PASTEUR~U1411AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229159	11/12/2004	MA	5.0	4		F	11/08/2004	Mom deep red swelling from site going down to elbow. No pain/ numbness. Itching. Given Keflex as precaution.				Y					N	11/04/2004	11/05/2004	1	NONE	UNK	UNK	Albuterol as need for asthma, Augmentin just finished x 10 days for ear infection ? Amox x 10 days prior	Ear infection resolving	Asthma, no allergy			1						1	Erythema; Injection site erythema; Injection site swelling; Pruritus; Swelling	FLUX~UNKNOWN MANUFACTURER~U1503AA~3~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0229161	11/12/2004	KS	50.0	49		F	11/09/2004	Developed a 2 circular, raised, red wheal at injection site with soreness and pruritus. Approximately 18 hours after vaccine given.				Y					Y	11/01/2004	11/02/2004	1	NONE	PVT	PVT	Allegra, Sudafed, Fonase Nasal Spray, Zoloft, Zantac	NONE	Environmental Allergies, sulfa allergy, GERD			1						1	Injection site erythema; Injection site reaction; Pruritus; Tenderness; Urticaria	FLU3~SANOFI PASTEUR~U1488AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229185	11/12/2004	VA	34.0	34		F	11/12/2004	Was vaccinated on 11/10/04 @ approximately 10AM.  When awoke 11/11/04 @ approximately 8AM, felt a tender knot in the left axillary region. No other symptoms at this time.									U	11/10/2004	11/11/2004	1	None at this time.  Student instructed to report any medical care if needed to VAERS - 800 phone number given.	MIL	PVT	Zocor, Paxil, ASA, Vitamins	Student denies	High Cholesterol Stress			1						1	Skin nodule; Tenderness	FLU3~SANOFI PASTEUR~U1580AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229186	11/12/2004	VA	42.0	41		F	11/12/2004	Vaccine given 11/10/04 @ about 10AM, noted a tender knot on the left side of her neck when she arose on 11/11/04.									U	11/10/2004	11/11/2004	1	None at this time.  Student was given VAERS 800 number to report any medical care if it became needed.	UNK	UNK	None	Denies	High cholesterol			1						1	Skin nodule; Tenderness	FLU3~SANOFI PASTEUR~U1580AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229188	11/12/2004	OH	83.0	82		F	11/12/2004	Patient received Fluzone, lot 1383AA, on 10/20/204 via IM injection into the left Deltoid muscle. Later the same day, she developed frontal headaches, nausea, dizziness and left sided numbness of her arm and leg. She states she was so dizzy that she had to lie down on the kitchen floor and had to be assisted to the bedroom. She did not have loss of use of her left extremities, did not confusion or other mental status changes, and did not have slurred speach. The symptoms resolved after several hours.				Y					Y	10/24/2004	10/24/2004	0	CT of the head was normal Cardiac echo was normal Carotid dopplers were normal	UNK	UNK	ASA 325mg /day Prevacid 30mg/day Toprol XL 25mg 1/2 tab/day Tambocor 100mg 1.5 tab/day	None	Atrial fibrillation Diastolic dysfunction allergic rhinitis migraine headaches GERD			1						1	Dizziness; Headache; Hypoaesthesia; Nausea	FLU3~SANOFI PASTEUR~U1383AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229194	11/12/2004	WI	78.0	78		F	09/12/2004	Approximately 10 hours after receiving flu shot, pt felt warm (not certain of temp), had chills, and experienced rapid pulse of 129 (normal for pt is 65). Arm was sore and area of around site was red. Pt did not treat with OTC's. By morning arm still sore, but other symptoms resolved. There was no respiratory difficulty. Pt did not call MD. Resumed ADL's within 24 hours.									Y	11/09/2004	11/09/2004	0		PUB	PVT		NONE	Pt states she usually has local reaction to flu shot (mild). MD Aware.			1						1	Chills; Feeling hot; Injection site erythema; Injection site pain; Similar reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~U1490AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229191	11/14/2004	VA	51.0	51		F	11/14/2004	Patient received flu vaccine (Aventis) and developed shingles on the face 16 days later.  Treated with Acyclovir 1000mg tid. Trigeminal nerve dermatone- intense redness, itching, pain, swelling.									Y	10/06/2004	10/26/2004	20		UNK	UNK	Premarin, Norvasc	None	Allergic: Keflex, Amoxicillin. Hypertension. TAH/BSO			1						1	Erythema; Herpes zoster; Pain; Pruritus; Swelling	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228290	11/15/2004	KY	8.0	7		M	10/26/2004	Vaccine adm 3:30 pm, 6pm began with flush, itching of scalp, neck/ear red, warm.  Slept good Sat.  OK, Sun (10/24/04)woke up at  7am, 1/4-1/2 diam round, raised reddish mearly on arm of injection site Lt.  Soreness at site, called dr.  Stop anti, give Zyrtec; by pm rash gone.									Y	10/22/2004	10/22/2004	0	none done	UNK	UNK	Advair-inhaler	on Biacin 10/10/04 Bronchitis	Asthma, allergy to Mold, Pollen, dust, feathers		KY2004041	1						2	Erythema; Feeling hot; Flushing; Injection site erythema; Injection site pain; Injection site swelling; Pruritus; Erythema; Feeling hot; Flushing; Injection site pain; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U1394DA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1394AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0229200	11/15/2004	SC	68.0	67		F	11/15/2004	On Oct. 18, 2004, four hours after receiving vaccine arm became red, painful, and hot to touch.  10/20; seen by doctor who stated looks like staph.  Patient given Biaxin 1000 mg and responded with systemic redness and wheezing.  Admitted to hospital via ER.  Given Benadryl, Ancef IV, and an antiemetic.  Continued on antibiotics and discaharged from hospital on 10/22 on po Doxycycline. Discharge Summary received on 12/22/2004 states pt experienced cellulitis, allergic drug reaction, and COPD exacerbation.				Y	Y	2			Y	10/18/2004	10/18/2004	0	Staph culture done.	UNK	UNK	NONE	NONE. 2 weeks before treated for bronchitis (Levoquin and Doxycycline)	COPD (Chronic obstructive pulmonary disease)		SC0445	1						1	Bacterial infection; Cellulitis; Condition aggravated; Hypersensitivity; Injection site erythema; Injection site pain; Injection site warmth; Wheezing	FLU3~SANOFI PASTEUR~U13842A~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0685N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0229202	11/15/2004	SC	82.0	82		F	11/15/2004	left upper arm displaying local reaction measuring 6 1/4 inches long by 9 inches wide-red, warm									Y	11/03/2004	11/05/2004	2		UNK	UNK	Prevacid, Lomox, Evista	NONE	GERD;  Irritable bowel syndrome		SC0446	1						1	Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U1457AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~MASS. PUB HLTH BIOL LAB~Td119~2~IM~LA~TD ADSORBED (TDVAX)~1	USA		Influenza
0229204	11/15/2004	NJ	76.0	75		M	11/15/2004	Ocular Respiratory Syndrome patient experienced sinus congestion and eye drainage approximately 24 hours after vaccine administered (deltoid) progressed to cough, increased rhonchi catarrhal film over eyes  pseudoephedrine administered  cefazolin 1 gm IVPB (x 2 or 3 doses) levofloxacin									Y	11/06/2004	11/07/2004	1	11-8   eye secretions cultured- hemophilus influenzae urine culture- Strep agalactiae (group B) blood culture- no growth	UNK	UNK	fentanyl patch dexamethasone, po docusate sodium tamsulosin lansoprazole	Intractable back pain UTI	malignant melanoma/sarcoma  history of Penicillin class allergy			1						1	Cough; Eye discharge; Nasal congestion; Respiratory disorder	FLU3~SANOFI PASTEUR~U1445AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229208	11/15/2004	KY	26.0	26		F	10/22/2004	Left arm reddened, swollen with several knots c/o clammy, feverish, headache, Lt arm pain worse today (10/22/04) than yesterday, knots warm to touch.									Y	10/20/2004	10/21/2004	1		MIL	PVT	none	no	none		KY2004042	1						1	Cold sweat; Headache; Injection site erythema; Injection site mass; Injection site swelling; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U1443AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~A066AA~1~IM~LA~HEP B (ENGERIX-B)~1	USA		Influenza
0229209	11/15/2004	CA	31.0	30		M	11/15/2004	Erythema on Right upper arm, minimal swelling.  Pt stated mild shortness of breath.									Y	11/11/2004	11/12/2004	1	None	UNK	UNK	Unknown	None	Unknown			1						1	Dyspnoea; Erythema; Swelling	FLU3~SANOFI PASTEUR~U1519AB~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0490P~1~SC~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0229210	11/15/2004	KY	50.0	50		F	11/01/2004	2 hours after injection, started to wheeze with some breathing difficulty, used albuterol inhaler (1 puff), next day- had red rash about size of golf ball was hot and puffy									Y	10/27/2004	10/27/2004	0	none	UNK	UNK		none	morphine and Aspirin   Asthma and Emphysema		KY2004043	1						1	Dyspnoea; Erythema; Oedema; Rash; Wheezing	FLU3~SANOFI PASTEUR~U1443AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229211	11/15/2004	OH	49.0	48		F	11/08/2004	10/28/04 rec'd c/o from patient of joint pain that began 3 days after vaccination and has persisted x 1 week.  Responds to Ibuprofen- c/o severe ankle and neck, knee pain.  Afebrile, no rash or edema.  No resp. or C-I sx. (hx-MS)									U	10/18/2004	10/21/2004	3	none	UNK	UNK	Meds for MS daily (non-steroidal)	none	Multiple Sclerosis		KY2004044	1						1	Arthralgia; Neck pain	FLU3~SANOFI PASTEUR~U1443AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229213	11/15/2004	CA	81.0	81		F	11/15/2004	Took shot on Wed.  Thurs lethargic, Fri fever, sore throat, took hot bath and to bed with chills, woke up with achy body, still sore throat but by noon cleared.  Spit up phlegm for two days.  Tonsils were swollen on Fri, but normal on Sun.  I have not been ill for 16 years, am cared for by a prevention doctor, with clear heart, immune system strong, no other problems. I used Echinesia, and gargled with Listerine, bed rest.  I continued to spit up muccous for two days, with a mild fever.									Y	11/10/2004	11/12/2004	2	Obviously this was a touch of the flu, ie., the fever, aches, chills, sore throuat, nasal drainage and swollen tonsils, in an otherwise health patient.	UNK	UNK	Thyroid by Armour, vitamins, DHEA 10.	None	none			1						1	Chills; Influenza like illness; Lethargy; Pain; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea; Tonsillitis	FLU3~SANOFI PASTEUR~U1489AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229214	11/15/2004	TX	75.0	74		M	11/12/2004	From initial information received on 11/5/04 from the patient who is a physician regarding an adverse event occurring in the USA, it was reported that he, a 74 year old male, received a FLUZONE vaccination, lot number U1381AA, administered on 10/14/04. Two days after the vaccination the patient developed a headache which persists to the present and radiates to his left eye. The patient was seen by an ophthalmologist and diagnosed with third cranial nerve palsy left sided. The patient recovery status is listed as unknown. (OMIC)				Y					U	10/14/2004	10/16/2004	2	CAT SCAN, MRI of head and MRA: results not provided.	UNK	UNK	Proscar; ASA; Tylenol		The patient denies any illnesses at the time of vaccination. The patient has a past medical history of high blood pressure and diverticulitis and environmental allergies.		200403638	1						1	Headache; IIIrd nerve paresis	FLU3~SANOFI PASTEUR~U1381AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229225	11/15/2004	NY	1.21	1	.2	M	11/08/2004	Patient had emesis and fever evening of 11/4/04. On morning of 11/5/04, mom found patient unresponsive. Diagnosed with cardiomyopathy; transferred to care center. Questionable myocarditis. Follow up 01/20/05: Patient has not fully recovered. He has cardiomyopathy, on Digoxin and Enalapril, requires close cardiology follow up. Also, had a stroke while on ECMO with residual neurological deficits, which are unknown in detail to us at this time. As Per annual Follow up: cardiology note dated 8/12/05 states he had biopsy done 7/22/05 with signs of myocarditis evident, despite considerable immunosupression. He is on Imuran, Predinsone, Cyclosporine, Enalpril, as well as Amiodarone. he has had evidence of myocarditis for m months. Long term sequelae of this is yet to be known. Medical records state respiratory failure, septicemia, systemic inflamation, congestive heart failure, hyper potassimia, hypertension, respiratory virus, occluded cariotid artery, swallowing problems, dyspnea, left sided weakness. msv			Y		Y				N	11/03/2004	11/05/2004	2	Currently on ECMO: possible heart transplant list Medical records stte abnormal lab tests, abnormal EKG. msv	PUB	PUB	NONE	NONE	NONE			1						1	Cardiac failure congestive; Cardiomyopathy; Carotid artery occlusion; Coma; Dysphagia; Electrocardiogram abnormal; Hemiparesis; Hyperkalaemia; Hypertension; Inflammation; Laboratory test abnormal; Myocarditis; Pyrexia; Respiratory failure; Respiratory tract infection; Sepsis; Viral infection; Vomiting	FLU3~SANOFI PASTEUR~U1465AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0320P~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1098N~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0229226	11/15/2004	TX	0.5	0	.5	F	11/12/2004	Seizure lasting approximately 10 minutes. Body jerking 15-20 minutes. ER evaluation and then admitted for 3 days. Testing normal.					Y	3			Y	11/10/2004	11/10/2004	0	Lumbar puncture; Blood culture; EEG; CT head.	PVT	PVT	Pediacare	Mild URI previous 48 hours.	NONE			1						1	Convulsion; Dyskinesia	DTAP~SANOFI PASTEUR~U1290CA~3~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1447AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE415AA~3~IM~LL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~X1040~3~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~A67180A~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0229227	11/15/2004	FL	60.0	59		M	11/15/2004	Fatigue, heavy chest congestion, cough since receiving a flu shot 1/04. Blood in sputum two times; cultured for Serratia Marcescens for several months. Given Levaquin. Medical records state blood in sputum. msv			Y						Y	01/15/2004	01/21/2004	6	Heavy Serratia Marcescens; Sputum culture Information from medical records states bacterial infection. msv	PUB	PVT	Flovent; Tussibid; Levoxyl	Cold	Medical record states hypothyroid, low testosterone level, bronchial asthma, chronic structural lung disease. msv			1						1	Bacterial infection; Cough; Fatigue; Haemoptysis; Laboratory test abnormal; Nasal congestion	FLU3~EVANS VACCINES~765957~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening	Influenza
0229232	11/15/2004	VT	41.0	41		F	11/11/2004	Weird feeling, aches, chest discomfort									Y	11/04/2004	11/04/2004	0		PVT	UNK		NONE	NONE			1						1	Chest discomfort; Feeling abnormal; Pain; Chest discomfort; Chest pain	FLUN3~MEDIMMUNE VACCINES, INC.~500333P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~IN50333P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0229233	11/15/2004	CA	1.92	1	.9	M	11/15/2004	Vomiting x 2 then fine. (48 hours after vaccine).									Y	11/11/2004	11/13/2004	2		PVT	PVT						1						1	Vomiting	FLU3~SANOFI PASTEUR~U1497AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229234	11/15/2004	VT	42.0	41		F	11/11/2004	Fleeting episode of palpitations chest pain lasting 2 hours.									Y	11/04/2004	11/04/2004	0	NONE	PVT	UNK	NONE	NONE	NONE			1						1	Chest pain; Palpitations; Chest discomfort; Chest pain; Palpitations	FLUN3~MEDIMMUNE VACCINES, INC.~500333P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~IN50033P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0229235	11/15/2004	VT	40.0	40		M	11/11/2004	Palpitations and felt anxious. Lasted 1/2 hours.									Y	11/04/2004	11/04/2004	0		PVT	UNK	NONE	NONE	NONE			1						1	Anxiety; Palpitations; Anxiety; Chest discomfort; Chest pain; Palpitations	FLUN3~MEDIMMUNE VACCINES, INC.~500333P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~IN50333P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0229236	11/15/2004	VT	31.0	31		F	11/11/2004	Felt weird, left sided chest pain.									Y	11/04/2004	11/04/2004	0	NONE	PVT	UNK	NONE	NONE	NONE			1						1	Chest pain; Feeling abnormal; Chest discomfort; Chest pain; Feeling abnormal; Pharyngolaryngeal pain; Rhinitis	FLUN3~MEDIMMUNE VACCINES, INC.~500333P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~IN50333P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0229237	11/15/2004	WA	51.0	50		F	11/08/2004	Facially swelling and redness. Treated by provider with Claritian									Y	11/05/2004	11/06/2004	1		PUB	UNK			NONE			1						1	Erythema; Swelling face	FLUN3~MEDIMMUNE VACCINES, INC.~500338p~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229238	11/15/2004	MD	6.0	5		M	11/05/2004	Vomiting around 30 times in 48 hours. Seen in ER 11/4/04 pm and given 1.5L IV fluid. Mother notified us 11/5/04. Mother states child had low grade fever 100-104. 1 Loose stool. Illness resolved by 11/5/04.				Y					Y	10/21/2004	11/03/2004	13	Formal serum electrolytes . Normal complete blood count, normal chest x-ray.	OTH	UNK	NONE	NONE	NONE			1						1	Diarrhoea; Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~50033P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0229239	11/15/2004	GA	39.0	38		F	11/05/2004	Sustained flu-like symptoms (x 5 days) of moderate severity, with coryza, aches, severe congestion.									Y	10/26/2004	10/26/2004	0		UNK	UNK		NONE	NONE			1						1	Influenza like illness; Nasal congestion; Pain; Rhinitis	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229240	11/15/2004	GA	58.0	58		F	10/06/2004	Stated had B-12 1 week ago in LD. Received flu vaccine left deltoid 10/5/04. Immediately soreness. Swelling started in PM. Redness and raised rash started 10/6/04 at 9am. Felt cold and hot since flu shot. Patient called MD office. They advised her to put cold compress to arm and take Tylenol q 4 hours prn.									N	10/05/2004	10/06/2004	1		PUB	PVT	B-12 1 week prior	NONE	Seizures		GA04041	1						1	Chills; Erythema; Feeling hot; Rash; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U1421AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229241	11/15/2004	NC	1.09	1	.1	F	11/12/2004	Swelling (2cm), redness (1cm). Swelling occurred at Prevnar injection site.				Y					U	11/10/2004	11/11/2004	1		PVT	PUB	Motrin	NONE	NONE			1						1	Erythema; Injection site reaction; Swelling	FLU3~SANOFI PASTEUR~U1427AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1036N~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~74398K~3~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0115P~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0229242	11/15/2004	OH	48.0	48		F	11/09/2004	Had flu vaccine 10/5/04 in AM. Arm ached the night of 10/5/04. Did not look at arm till afternoon of 10/6/04 and noticed large, raised area on upper arm. Area was warm and red. Areas was 4 in diameter from site. Swelling went down after 5 days, redness lasted 2 weeks. I saw site one week later and site appeared reddened 4 diameter/ location of site probable S/Q instead of IM/									Y	10/05/2004	10/05/2004	0		PVT	PVT	Pulnicort, Albuterol aerosols prn	NONE	Asthma			1						1	Injection site erythema; Injection site oedema; Injection site swelling; Injection site warmth; Pain	FLU3~SANOFI PASTEUR~U1445AA~3~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229243	11/15/2004	NV	51.0	50		F	11/13/2004	pain and soreness at injection site.									U	10/20/2004	11/02/2004	13		PVT	UNK		NONE				1						1	Injection site pain; Tenderness	FLU3~SANOFI PASTEUR~U1453CA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229244	11/15/2004	NV	51.0	50		F	10/29/2004	Complaints of tenderness and soreness at injection site. No erythema or edema seen.									U	10/21/2004	10/22/2004	1		PVT	PVT		Bronchitis: 5 days later.				1						1	Injection site pain; Tenderness	FLU3~SANOFI PASTEUR~U1394EA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229245	11/15/2004	OH	0.54	0	.5	F	10/28/2004	Gasping respiration, diaphoretic, hives, decreased breath. Sounds upper lobes, absent lower lobes, mildly tachycardic. Remained pink throughout episode. Episode lasted 3-5 minutes, recovered spontaneously.									Y	10/25/2004	10/25/2004	0		PUB	PUB	NONE	NONE	NONE			1						1	Dyspnoea; Flushing; Hyperhidrosis; Respiratory rate decreased; Tachycardia; Urticaria	DTAP~SANOFI PASTEUR~U1301AA~1~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1459AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0090P~1~IM~LL~HIB + HEP B (COMVAX)~1|IPV~SANOFI PASTEUR~X0800~1~SC~LL~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0229246	11/15/2004	PA	65.0	65		F	11/07/2004	On the next evening following the injection 10/8/04, I noticed a rash and itching of legs. After that I noticed a rash and itching that developed first on the area on the inner aspects of the arms above the wrists and gradually spread to the legs, back, chest, upper arms. The only place I didn't have a rash was my face. This has been happening for one month. The Allegra keeps the rash and itching down.				Y					N	10/07/2004	10/08/2004	1		UNK	UNK	Norpramin, Buspar, Actonel , Vitamin C, E, Viactiv	NONE	Tetanus inj, sulfa, glaucoma drops, Boriasis			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U1446AA~5~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~U1138~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0229247	11/15/2004	NM	56.0	55		F	11/09/2004	Shot site was sore for days that was in October 03. Jan04: Pain in chest and hurting under chest bone. Loose stool, discomfort, stress, anxiety, unwell feeling. Given antacid medication, but has not worked so far.									N	10/24/2003	01/26/2004	94	xray for swallowing, ultra sound, CT scan and endoscoping	UNK	UNK	Lipator, Hormone Replacement	High cholesterol only	High cholesterol only			1						1	Anxiety; Chest pain; Diarrhoea; Discomfort; Injection site pain; Irritability; Malaise	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0229248	11/15/2004	OK	67.0	66		F	11/05/2004	Patient experienced redness and swelling of right arm of injection site. Pneumovax 0.5ml was given at 1:30pm, on 11/3/04. Symptoms began 4.5-5 hours later on that same day. Spoke with patient 11/5/04 at 3:05pm and she's feeling much better.									Y	11/03/2004	11/03/2004	0		PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U1488A~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0926N~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0229249	11/15/2004	NM	0.77	0	.8	F	11/15/2004	No adverse reactions noted: was given a 0.25ml flu vaccination with preservatives instead of preservative free.									Y	10/18/2004			No lab tests done	PVT	PUB	NONE	NONE	NONE			1						1	Medication error	FLU3~SANOFI PASTEUR~U1456AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229288	11/16/2004	MA	57.0	57		F	11/15/2004	Patient received a influenza shot 10/18/04, Fluzone U1427AA, .05ml, IM. Patient nausea, low grade fever and chills and seen 10/25/04. She had sudden death 10/27/04. Medical Record received on 11/22/2004 states pt experienced viral syndrome, Baker's Cyst, and calf pain.	Y	10/27/2004							N	10/18/2004	10/20/2004	2	NONE	PVT	PVT	ASA; Trazodone; Niacin; Zantac	NONE	Obesity; Kidney stones; Depression; High Cholesterol; Sleep apnea; Hernia repair; Chronic pain.			1						1	Chills; Cyst; Nausea; Pain; Pyrexia; Sudden death; Viral infection	FLU3~SANOFI PASTEUR~U1427AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0229293	11/16/2004	MI	86.0	86		F	11/05/2004	Flu like symptoms to excess (body aches, hot flashes, chills, chest pain) C/P into neck, face swollen, difficulty breathing. Cardiac symptom: atrial fib. Discharge Summary received on 1/12/2005 states congestive heart failure. Medical Records received on 1/12/2005 states fatigue. Follow up 02/02/05: Patient remains much weaker, more tired than before the vaccination. She gets somewhat shakey at times and has less energy. Her hoarseness is worse and her appetite is diminished. The chest pain, facial swelling, and extreme tiredness experienced within 2 hours of having the vaccine are gone now. Extreme shortness of breath is gone, but she still has more shortness of breath than before.				Y	Y	6			Y	10/20/2004	10/20/2004	0	Chest x-ray: COPD 10/21; Chest x-ray: Pneumonia 11/04; BUN elevated 24.7; CO2 elevated 30.4; Sedimentary rate increased 57. Medical Records received on 1/12/2005 state the pt did not have pneumonia.	PUB	PVT	Levothyroid; Evista; Advair; Nitro BID	Heart murmur	Heart murmur; High blood pressure; Questionable breathing disorder. Discharge Summary received on 1/12/2005 states COPD. Medical Records received on 1/12/2005 state degenerative joint disease.			1						1	Atrial fibrillation; Cardiac failure congestive; Chest pain; Chills; Dyspnoea; Face oedema; Fatigue; Hot flush; Influenza like illness; Laboratory test abnormal; Pain	FLU3~SANOFI PASTEUR~U1453CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0229294	11/16/2004	CA	1.04	1	.0	F	11/09/2004	Conjunctivitis, erythematous tongue/lips, rash (maculopapular) on back, SM/cervical nodes, fever about 6 days. Presumptive Kawasaki disease. Discharge Summary received on 1/3/2005 states pt experienced adenopathy.  Medical Record received on 1/3/2005 states pt experienced anorexia and was irritable.					Y	1			U	10/28/2004	11/05/2004	8	WBC 16.9; ESR 80	PUB	PUB	Motrin	NONE	NONE			1						1	Anorexia; Conjunctivitis; Erythema; Irritability; Kawasaki's disease; Laboratory test abnormal; Lymphadenopathy; Pyrexia; Rash maculo-papular	FLU3~SANOFI PASTEUR~U1407AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0229295	11/16/2004	TN	1.56	1	.6	M	11/10/2004	Severe urticarial reaction				Y					Y	11/04/2004	11/04/2004	0	Referred to dermatology to confirm diagnosis.	PVT	PVT	NONE	NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1381AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229296	11/16/2004	IL	1.61	1	.6	M	11/01/2004	High fever , seizure lasting 40 min: 10 days after MMR no. 1. Medical records received on 1/20/2005 states cough and congestion.				Y					Y	10/21/2004	10/31/2004	10	CBC, metabolic panel, blood/ urine culture. Medical records received on 1/20/2005 states low NA, low K, and low Cl.	PVT	UNK		NONE	History of febrile seizure 6/04			1						1	Convulsion; Cough; Hypocholesterolaemia; Hypokalaemia; Hyponatraemia; Nasal congestion; Pyrexia	FLU3~SANOFI PASTEUR~U1389AB~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0771P~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0229297	11/16/2004	WI	90.0	90		F	11/08/2004	On 10/29/2004 total body aches, swollen hands: sore, HA. So sore she couldn't get out of bed. By 11/1 she was better. Better, but not quite himself.									N	10/26/2004	10/29/2004	3		PUB	UNK	Torsamide, Korcan, Tylenol, Plavix, HCTZ, ASA, Anti-inflammatory		Allergy to Sulfa			1						1	Headache; Oedema peripheral; Pain; Tenderness	FLU3~SANOFI PASTEUR~U1478AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229298	11/16/2004	PA	2.0	2	.3	F	11/08/2004	Received immunization (Fluzone) 2NOV04. Woke upon 3NOV04 with maculopapular rash on trunk that over course of next days progressed and spread to extremities. No pruritus , no other symptoms, no fever, no URI symptoms.									U	11/02/2004	11/03/2004	1		PVT	PVT		NONE	Healthy child			1						1	Rash maculo-papular	FLU3~SANOFI PASTEUR~U1427AA~3~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229299	11/16/2004	NY	80.0	79		F	11/11/2004	Pain at injection site (2 deltoid) beginning 90 min after injection with motor weakness of deltoid for next 48 hours.									U	11/09/2004	11/09/2004	0		PVT	UNK	Vitamins	non-Hodgkins Lymphoma				1						1	Injection site pain; Muscular weakness	FLU3~SANOFI PASTEUR~U1505AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229300	11/16/2004	HI	56.0	55		F	11/01/2004	Fever 100F, Abdominal pain, Myalgias, Headaches, Chills: within 6 hours of vaccine.									Y	10/27/2004	10/27/2004	0		PUB	PVT	Lantas, Metfermin, ASA, Zestor, Humalog, Levastatin, Neurontin, Lexicid		DM, UTI, Neuropathy			1						1	Abdominal pain; Chills; Headache; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1377AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229301	11/16/2004	WA	81.0	81		M	09/06/2004	Within the first 24 hours his heart rate increased. When I took his pulse it was about 93 beats per minutes. He was not ill, but said he did not feel very well. He has had each of the three shots given (listed below) with no adverse reactions when each was given separately in the past.									Y	10/28/2004	10/29/2004	1	He had 3 vaccines at once: flu vaccine, pneumococcal polysaccharide and tetanus and diphtheria vaccine (TD).	PUB	PUB	Aspirin, Diltiazem Hydrocholorathiaze, Isorbide Mono Nitrate, Lisinopril, Metropolol, Potassium, Proscar, Simvastin, Warfarin, Multiple Vitamin/Mineral, Fish oil: Omega-3, Hawthorne, Betaine HCL, Saw Palmetto, Garlic, CoQ10, Calcium Citrate	No illness: was feeling very well.	Heart patient for many years: has had 6 defibrillatory pacers since 1992			1						1	Malaise; Tachycardia	FLUX~UNKNOWN MANUFACTURER~U1478AA~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~0524P~UNK~~~PNEUMO (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~U1018BA~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0229302	11/16/2004	VT	88.0	88		F	11/10/2004	Patient complained of feeling flushed: did not appear flushed. Complained of difficulty breathing. Observed by RN at site. Patient given Lorazepam 0.25 mg orally. Patient exhibited increasing shortness of breath with puffy eyes. Doctor called. Pt given epinephrine 0.3cLx1 at 2PM. 2:15 patient transported to Emergency Department by ambulance. No interventions at hospital ED. Pt recovered by time of arrival. Diagnosis: possible reaction to flu shot vs. anxiety.				Y					Y	11/05/2004	11/05/2004	0		UNK	UNK		NONE	post CVA, major depression, general anxiety and pa, mild COPD			1						1	Anxiety; Dyspnoea; Eye swelling; Flushing	FLU3~SANOFI PASTEUR~U1557AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229303	11/16/2004	WI	58.0	57		F	11/11/2004	Developed face flushing within 3 hours of vaccine. Saturday, 11/6/04, developed raised, itchy rash from head to foot including palms of hands and soles of feet. Looked like chicken pox without the blister. Took Benadryl / Zantac 11/6/04 and 11/7/04 and relief. Seen by MD 11/8/04. Allergist, Prednisone and Zantac 11/20/04 resolving.				Y					Y	11/05/2004	11/05/2004	0	NONE	PVT	PVT	Ogen(hormone replacement)	NONE	Claritan for Japanese lady bugs allergy			1						1	Flushing; Pruritus; Rash; Rash erythematous	FLU3~SANOFI PASTEUR~U1448AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229304	11/16/2004	MA	1.25	1	.3	M	11/09/2004	Immunizations given 11/2/04. On 11/4/04, broke out in hives all across upper shoulders and buttocks. Afebrile.									Y	11/02/2004	11/04/2004	2		PVT	PUB	NONE	NONE	NONE			1						1	Urticaria	DTAP~SANOFI PASTEUR~1301DA~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1439AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE222AA~4~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A74398A~4~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0229305	11/16/2004	WI	30.0	29		F	11/10/2004	Approximately 20 min after receiving an Influenza vaccination, patient feet itching and hives. No shortness of breath. She denied allergy to eggs to nurse administering vaccine. However, when seen in ER, told PA she is allergic to eggs. Medical Record received on 1/12/2005 states									Y	11/04/2004	11/04/2004	0	Seen in Hospital ER at 11:15 on 11/4/04. Liticorin type rash noted on upper extremities and trunk. Diagnosed: Allergic reaction to flu shot.	PUB	PVT	Abx	UTI;Medical Record received on 1/12/2005 states UTI.	Medical Record received on 1/12/2005 states allergy.			1						1	Hypersensitivity; Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U1381AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229306	11/16/2004	TX	69.0	69		F	11/08/2004	Patient's arm was sore about 1 hour after injection. Within 24 hours, she had a red oval swollen area from the shoulder to the elbows. Lasted about 1 week then was gone.									Y	10/11/2004	10/11/2004	0		UNK	UNK		NONE	NONE			1						1	Erythema; Pain; Swelling	FLU3~SANOFI PASTEUR~U1440AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229307	11/16/2004	VA	56.0	55		F	10/15/2004	Nasal and chest congestion. Right arm numbness to hand. Body aches.				Y					U	10/13/2004	10/15/2004	2	Abx given Levoquin 500mg Tqd	PVT	PVT			Chronic arthritis, asthma fibromyalgia			1						1	Hypoaesthesia; Nasal congestion; Pain; Pulmonary congestion	FLU3~SANOFI PASTEUR~U1462AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229308	11/16/2004	VA	59.0	58		M	11/15/2004	Nasal and chest congestion. Right arm numbness to hand, body aches				Y					U	10/13/2004	10/13/2004	0	Abx given Levaquin 500 mg Tqd	PVT	PVT			Chronic Arthritis, Kidney Disease, Asthma			1						1	Hypoaesthesia; Nasal congestion; Pain; Pulmonary congestion	FLU3~SANOFI PASTEUR~U1462AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229309	11/16/2004	MO	68.0	67		F	11/02/2004	Received vaccine at 3:00. Around 5:30 noted blisters on tongue, mouth, states felt like the blisters were going down her throat. At bedtime noted improvement; took Benadryl. No respiratory distress by AM: blisters resolved. Also noted constipation.									Y	10/18/2004	10/18/2004	0		UNK	UNK	Prevacid, Premarin, Pravachol, Metaglip, Amiloride Hcl/Hctz, Hydrocodone Apap, Albuterol, Nasonex, Calcium, Vit D, Claritan D, Darvocet N/APAP, Lasix, Potassium	NONE	Asthma, Type 2 Diabetes; reflux, sulfa, Biaxum, Zinc, strawberries, pineapple.			1						1	Blister; Constipation; Mouth ulceration; Oral mucosal blistering	FLU3~SANOFI PASTEUR~U150AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229310	11/16/2004	PA	55.0	55		F	10/29/2004	A nurse reports accidental exposure to the flu following administration of Flumist to a pt in a physician's office. She presented with symptoms of burning eyes, scratchy throat, fever with chills, feeling achy and still with occasional cough four days after administering Flumist. The reporter stated that she had administered her first and only dose of Flumist to a child on 22Oct04. The child immediately sneezed after receiving FluMist. On 26Oct04, four days after exposure from the child's sneeze, the reporter became very achy and stiff. She developed a 101.8 degree fever with chills, scratchy throat, burning eyes, as well as a complaint that her joints hurt worse on 27Oct04. She began treatment with ibuprofen and the events improved. On 28Oct04 the chills continued along with the aches, burning eyes, and occasional cough. As of 29Oct04 she was mildly achy and her eyes continued to burn but she stated that she felt better. Of note, the reporter received a flu vaccine three weeks prior to her exposure to FluMist. No further information is available.									N	10/22/2004	10/22/2004	0	None indicated.	OTH	OTH	Concomitant drug(s) not reported.		None indicated.		MEDI0002360	1						1	Arthralgia; Chills; Cough; Eye irritation; Hypotonia; Infection transmission via personal contact; Medication error; Myalgia; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500335P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229311	11/16/2004	NE	49.6	49		F	10/25/2004	A consumer reported the development of redness on the neck and face of her 49 year old sister hours after receiving her first FluMist inhalation. The pt has a history of early childhood brain damage associated with whooping cough and a detailed history involving drug reactions to other medications. Detailed drug allergy history was not provided. The pt received FluMist on the afternoon of 23Oct04. The reporter stated that by dinner a red streak formed done one side of the pt's face and it had gradually spread to her neck by evening. Pain nor itching were not reported. As of 28Oct04 the redness had resolved.									Y	10/23/2004	10/23/2004	0		OTH	PVT	Unidentified seizure medication	Brain damage	Detailed drug allergy history was not provided; brain damage from whooping cough at age 6		MEDI0002335	1						1	Erythema	FLUN3~MEDIMMUNE VACCINES, INC.~500334P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229330	11/17/2004	KY	70.0	69		F	11/10/2004	Limited mobility left arm; pain from shoulder to elbow				Y					U	10/25/2004	10/26/2004	1		UNK	UNK	Ambien, Synthroid, Myocalcium	none	Hypothyroidism, Osteoporosis, allergic to PCN, Sulfa		KY2004045	1						1	Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U1504AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229333	11/17/2004	KS	71.0	71		F	11/17/2004	Client came in to the HD on 11/17/04, four days after recieving the flu shot, reporting that her arm was swollen and red. The swelling started a few hours after the injection and had improved somewhat since then. Said she had a slight fever of 99/6 to 99/8 starting the 2nd day after the shot. Today her arm had an area of redness and some swelling with a litlte warmth 3 by 4. While the client was here we called her physician to set up an appointment for evaluation. He saw her a couple of hours later. When we called the client on 11/15/04 she said the Dr. said he was 90% sure she had a reaction to the shot; not to get any more flu shots again. He gave it a 10% chance of being cellulitis and Rxed an antibiotic. Client reports her arm is better.				Y					Y	11/09/2004	11/09/2004	0	None	UNK	UNK		None				1						1	Cellulitis; Erythema; Feeling hot; Swelling	FLU3~SANOFI PASTEUR~PMC U1453FA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229335	11/17/2004	MD	34.0	34		F	11/17/2004	Received Fluzone ~0930.  Developed palpitations ~1000. Developed resp. distress ~ 1015. Used personal inhaler at that time w/o relief.  Repeated x1 w/o relief.  Contacted PMD, who directed her to ED.  Arrived at ED ~1200. Received Benadryl 50mg po.  Only other sx. was dizziness; no hives, nausea.  To continue onZyrtec x1 week.  D/D diagnosis Asthma exacerbation d/t flu vaccine.				Y					U	11/16/2004	11/16/2004	0	None	UNK	UNK	prenatal vitamins albuterol inhaler PRN	none	asthma multiple pharmacological and environmental allergies Medical records state pregnancy. msv			1						1	Condition aggravated; Dizziness; Palpitations; Respiratory distress	FLU3~SANOFI PASTEUR~U1383AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229336	11/17/2004	MI	52.0	52		M	11/17/2004	Did not see any change in temperature, however the evening following the vaccination he was quite diaphoretic, and weak that evening and the following day.									Y	11/11/2004	11/11/2004	0		UNK	UNK						1						1	Asthenia; Hyperhidrosis	FLU3~SANOFI PASTEUR~u1579AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229346	11/17/2004	CA	4.0	4		M	11/02/2004	Left whole upper arm was swollen hugely and erythematous, slightly tender, heavy and itchy. Double size of arm. Got better in four days with Benadryl									Y	10/27/2004	10/27/2004	0		PVT	PVT		NONE				1						1	Erythema; Pruritus; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U1447AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229347	11/17/2004	IL	26.0	26		F	11/11/2004	Symptoms began with sore shoulder 1-2 days after injection the sore elbow around 10 days after injection burning and numbness in left hand. 10/27 was seen in clinic to follow up with neurology. 10/28 had new burning in both legs to the thigh. Seen in ER , had LP and neurology consult. Given Neurontin follow up out-patient. Had AMA and NCS 11/9: normal. Per neurologist's: autoimmune inflammatory polyneuropathy vs early Guillian Barre. 10/28: CBC, Chemistry Panel normal. 11/4: C3 C4 CRP RF ANLA: normal.   Follow up 03/07/05: Summary of nerve conduction studies: The left sural, posterior tibial and right peroneal respones are normal. the upper extermities, the left median and right radial sensor responses are normal. Motor conduction in the left media and ulnar nerves are normal. The left median CMAP amplitude proximall is larger thatn that distally. While stimulating over the median nerve in the antecubital fossa and recording over the abductor dititi minimi, a small response was obtained, consisent with median to ulnar (Martin-Gruber) anastomosis. Conclustions: This electrophysiologic study is normal. Specifically, there is no evidence for a large fiber polyneuropathy. The normal F-waves argue against acute inflammatory demeylinating polyradiculoneuropathy with symptoms presnet for two weeks. Clinical correlation is recommended. Incidently noted is a left median to ulnar forearm (Martin-Gruber) anastomosis, a normal variant seen in 15-30% of the population.  1/7/05 Information form patient:  She was hospitalized for 2 days and then followed up by a neurologit at the hospital.  At first they thought she had GBS, but now it has been diagnosed as chronic demyelating polyneuropathy.   03/07/05 From Medical Center Clinic Records; 03/07/05 Neurology Consult done in ER gives detailed exam findings and provides list of possible Dx; Auto-immune Inflamatory polyneuropathy named first and remains the finding.  Notes mention improvement on Neuronton.    03/08/2005 Neuro Clinic records reveal patient was diagnosed with auto immune inflammatory polyneuropathy.  Main symptoms were numbness, tingling, and pain.  These symptoms occurred 2 days after vaccination.				Y					N	10/14/2004	10/16/2004	2	CT head: no significant finding. MRI spine: no significant findings. SCI WBC PAC protein 18s 10/28 EMG, NCS 11/9: preliminary normal. ANA 1:80 10/28 and SR32 Follow up 03/07/05: 11/9/04 Electromyography: Cencentric needle recording of the left FDI was normal.   01/12/05 Hospital Labs: CSF test WNL w/no oligoclonal bands.  EMG, HIV, AIP, ANCA titer & ANA titer all WNL.  ESR mildly elevated at 32.	PVT	PVT	Orthotricycline	NONE	NONE			1						1	Hypoaesthesia; Neuropathy; Sensory disturbance; Skin burning sensation; Tenderness	FLU3~SANOFI PASTEUR~U1488~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229348	11/17/2004	MN	72.0	72		U		Heard this clinic giving shots: made appointment that very day (hands, feet, mass ice cold). Evening body very hot. Throat so sore: when to doctor, no strep throat. Took three weeks to get over the flu. My doctor said I got the flu from shot. He said take Tylenol twice a day.									Y	10/23/2004	10/23/2004	0		PVT	UNK		NONE				1						1	Chills; Feeling hot; Influenza; Pharyngolaryngeal pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0229349	11/17/2004	CA	31.0	30		F	10/22/2004	About 3 hours after flu shot, developed fatigue, achiness, light-headedness and sharp, stabbing headache. Also developed shivering and numbness in fingers and toes of about 12:00am. The shivering and numbness abated after 3 hours. 23 hours later, still feels tired, with headache.  No other symptoms. No fever.									Y	10/21/2004	10/22/2004	1		PVT	UNK	Pre-natal vitamins ( is nursing 6 months old)	NONE	NONE			1						1	Chills; Dizziness; Fatigue; Headache; Hypoaesthesia; Pain	FLU3~SANOFI PASTEUR~U1443AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229350	11/17/2004	NY	77.0	76		M	11/10/2004	3 days after the flu shot, I awoke with Extreme Weakness which lasted 3.5 days. No other symptoms. Treatment: bed rest, vitamins.									Y	10/20/2004	10/23/2004	3		PUB	PUB						1						1	Asthenia	FLU3~SANOFI PASTEUR~1114184A~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229351	11/17/2004	VA	69.0	69		F	11/11/2004	12x6.25 red area, warm to touch, also tender x 1 day. Advised Tylenol and cool compress.									Y	11/08/2004	11/08/2004	0		PVT	PVT		Est. care/ Hypertension	HTN, Hyperlipidemia, O/A, Anxiety disorder			1						1	Erythema; Feeling hot; Tenderness	FLU3~SANOFI PASTEUR~1427aa~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229352	11/17/2004	MD	64.0	64		F	11/08/2004	Hives, itching started 11/7/04 in 5-6pm. No fever/chills/SOB, wheezing				Y					N	11/07/2004	11/07/2004	0		PVT	UNK	Provigil, Estraco, Prilosec	NONE				1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229353	11/17/2004	MA	50.0	49		F	11/17/2004	Site was itchy immediately, around 24 hours later red, hot , swollen at injection site.									U	11/16/2004	11/16/2004	0		UNK	UNK		NONE	NONE			1						1	Injection site erythema; Injection site reaction; Injection site swelling; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U1555AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229354	11/17/2004	IL	0.5	0	.5	F	11/17/2004	At 6 months, well child check up 11/12/04: Baby received DTP #3 HIB#3 Pre#3, Fluzone#1. Within two minutes, patient covered with hives from head to toe. No anaphylaxis. No respiratory distress. Alert and playful. Received 2.75 Benadryl po within 20 min, hives faded. Babe sent home to follow up with allergy.									Y	11/12/2004	11/12/2004	0		PVT	PVT	NONE	NONE	NONE			1						1	Urticaria	DTAP~SANOFI PASTEUR~C2044AA~3~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~C1415AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE106AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~659B~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0229355	11/17/2004	AR	25.0	24		F	11/01/2004	Employee came to me 30 min (approx0 after influenza vaccine given, she was pale, clammy and shaky. She stated she was dizzy and nauseated. Had her sit down, placed cool wash cloth over forehead , blew into paper baby . Lasted approximately 30-45 min. Full recovery.									Y	11/01/2004	11/01/2004	0		UNK	UNK	NONE	NONE	Asthma			1						1	Cold sweat; Dizziness; Nausea; Pallor; Tremor	FLU3~SANOFI PASTEUR~I1512AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229356	11/17/2004	NJ	57.0	57		F	11/29/2004	Upon administration felt pain and tingling radiating down to fingertips ,tingling lasted for 1 hour. Doctor did not provide any recommendation. Then pain began from vax site to bottom of arm, restricted movement. Pain ha been chronic for 2.5 weeks and worsened to the point that can't raise arm to any degree. On 11/15 doctor prescribed Bextra 10mg daily.				Y					N	10/28/2004	10/28/2004	0		PUB	PVT	NONE	NONE				1						1	Injection site pain; Joint range of motion decreased; Pain; Paraesthesia; Discomfort; Hypokinesia; Paraesthesia	FLU3~SANOFI PASTEUR~U1455EA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1455EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0229357	11/17/2004	MO	34.0	34		F	11/05/2004	A physician reported ganglion cyst in a 34 year old female after receiving her first dose of Flumist. The patient received Flumist at 3 PM on the afternoon of 10/29/04. The patient noticed lumps on her right wrist that resembled a ganglion cyst the afternoon of 10/31/04. More of the cyst-like symptoms developed around her wrist 11/1/04. By 11/2/04, the cyst had spread to both wrist, feet, and ankles. On 11/3/04, the cyst were spreading to her arms. The reporter stated that it maybe urticaria but he is not quite sure how to identify the events. He is referring the patient to another physician. As of 11/5/04, the cyst have not progressed but have not resolved. The reporter stated he did not believe the event were due to use of Flumist. 07Feb05: Additional information obtained: pt's age and date of birth.									N	10/29/2004	10/31/2004	2	NONE	PVT	PVT	NONE		NONE		MEDI0002387	1						1	Cyst; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500338P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229358	11/17/2004	IL	32.0			M	11/11/2004	This is a non-serious spontaneous case from a pharmacist who reports he experienced chills after administering FLUMIST. The reporter did not provide causality between events and FLUMIST administration. This case is submitted according to the VAERS safety surveillance accelerated reporting agreement for FLUMIST. A 32 year old male experienced slight chills, body ache, and congestion after administering FLUMIST. On 10/26/04, the patient experienced slight chills, body ache, and congestion after administering his third of five FLUMIST doses. He treated himself with ibuprofen and recovered within 24 hours after onset of events. The patient did not have any problems with administering FLUMIST and he had administered FLUMIST one or two days prior to the onset of the events. On 10/01/04, the patient received influenza vaccination. Additional information (lot number 500337P) received on 08Feb05. There is no date of vaccination because pt did not receive FLUMIST. Follow up 03/14/05: Vaccine adminstration time/date is not applicable because the subject did not received FLUMIST. A VAERS follow up was submit on 03/4/05.									Y		10/26/2004		NONE	UNK	UNK	NONE				MEDI0002411	1						1	Chills; Nasal congestion; Pain	FLUN3~MEDIMMUNE VACCINES, INC.~500337P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229340	11/18/2004	CA	33.0	33		F	11/18/2004	Facial swelling from Flu shot.				Y					Y	10/27/2004	10/27/2004	0	None	MIL	MIL		No	No			1						1	Face oedema; Eye swelling; Face oedema; Skin burning sensation; Skin irritation	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1457AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0229390	11/18/2004	AL	0.86	0	.9	M	11/18/2004	APPROXIMATELY 24 HOURS POST VACCINATION, MOM NOTED A RASH ON BABY'S CHEST.  OF NOTE, MOM STATES BABY TO BE CRANKY AND WITH TACTILE TEMPERATURE ON THE DAY OF VACCINATION.  MOM DOES NOT REPORT ANY OF THE FOLLOWING:  COUGHING, WHEEZING, EYELID EDEMA, NOR LIP SWELLING.  RASH IS PAPULAR, NONPURITIC, AND CONFINED TO TORSO ONLY.									Y	11/16/2004	11/16/2004	0	NONE	UNK	UNK		NONE	NONE			1						1	Irritability; Pyrexia; Rash papular	FLU3~SANOFI PASTEUR~U1404AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229392	11/18/2004		18.0	18		F	11/19/2004	Erythema multiforme.				Y					U	11/09/2004	11/19/2004	10		MIL	MIL	amoxicillin	tonsillitis	allergic rhinitis			1						1	Erythema multiforme	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0229395	11/18/2004	PA	53.0	53		M	11/15/2004	From initial information received on 10NOV2004 from an RN regarding an adverse even occurring in the USA, it was reported that a 53 year old male patient, who is an ER physician , received a dose of FLUZONE, SV 2004-2005 USP, lot number U1427AA, administered IM in the right deltoid on 4NOV2004. Two days later, the patient felt feverish and achy. on 8NOV2004, he developed a severe headache on the left side of his head. On awakening the following morning, the  patient could not talk right and developed drooping of the left side of his face. He was also unable to close his left eyelid. The patient was diagnosed with Bell's Palsy. It was not reported whether he was seen by another physician or treated for these events. It is also unknown whether he recovered from these events.				Y					U	11/04/2004	11/09/2004	5		UNK	UNK			The patient has no know pre-existing medical conditions, birth defects or allergies. He denied any illnesses at the time of vaccination.		200403645	1						1	Eye disorder; Facial palsy; Headache; Pain; Pyrexia; Speech disorder	FLU3~SANOFI PASTEUR~U1427AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229405	11/18/2004	WV	27.0	26		M	11/16/2004	C/o dull ache 2 days after getting influenza and Td vaccines. Also viral type sxs fever, chills, diarrhea and vomiting starting 24 hours after vaccines and lasting 2 days. Not c/o mild aching pain left arm and severe aching pain right arm with limited ROM in right arm tx IgA Neuropathy.				Y					N	11/03/2004	11/05/2004	2		PUB	PUB	NONE	NONE	Hx of Bright's Kidney Disease (IgA Neuropathy)			1						1	Chills; Diarrhoea; Hypokinesia; Injection site pain; Myalgia; Neuropathy; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1383AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TTOX~SANOFI PASTEUR~U1354AA~UNK~~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0229406	11/18/2004	CA	0.58	0	.6	U		Had influenza vaccine 10/25/04 2 days later red patch at site. Few days later malaise, maculopapular rash with MU at site.				Y					U	10/25/2004	10/27/2004	2	CBC	PVT	OTH						1						1	Injection site erythema; Rash maculo-papular	FLU3~SANOFI PASTEUR~1442AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229407	11/18/2004	NY	6.0	6		F		Hives treated with Benadryl. Onset of hives one hr after vax.									Y	11/04/2004	11/04/2004	0		PVT	UNK	Flovent, Singulair	NONE	Asthma, Hives with Suprax, PCN, peanuts			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1445AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229408	11/18/2004	DC	16.0	15		M	11/18/2004	Pain in left deltoid x 3 weeks, weakness left deltoid x 1 week				Y					U	10/23/2004	10/30/2004	7		PVT	UNK						1						1	Asthenia; Pain	FLU3~SANOFI PASTEUR~U1457AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229411	11/18/2004	OH		43		F	11/06/2004	50mm red raised reaction at injection site, sore, T 97.8									Y	10/21/2004	10/22/2004	1	NONE	PUB	PVT		NONE	NONE			1						1	Injection site pain; Injection site reaction; Rash maculo-papular	FLU3~SANOFI PASTEUR~U1455CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229412	11/18/2004	OH		59		F	11/06/2004	Red sore and slight swollen at site next day.									Y	10/25/2004	11/01/2004	7	NONE	PUB	PVT		NONE	NONE			1						1	Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U1455CA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229413	11/18/2004	OH		58		F	11/06/2004	Red warm bruised left arm at injection site.									Y	10/25/2004	10/27/2004	2	NONE	PUB	PVT		NONE	NONE			1						1	Contusion; Feeling hot; Injection site erythema	FLU3~SANOFI PASTEUR~U1455CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229414	11/18/2004	OH				F	11/06/2004	Hard red area left upper arm									Y	10/25/2004	10/27/2004	2	NONE	PUB	PVT		NONE	NONE			1						1	Injection site erythema; Injection site mass	FLU3~SANOFI PASTEUR~U1455CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229415	11/18/2004	NC	26.0	25		F	11/18/2004	Employee began to feel poorly at 4AM on Wednesday morning. Symptoms included headache, fatigue, stuffy nose and head. Throat slightly red, afebrile. She took FluMist on Tuesday afternoon. She is talking Tylenol for headache. She has not seen a doctor.									U	11/16/2004	11/17/2004	1		OTH	PVT	Tylenol, Inderide, Levoxyl, Multivitamin		Seasonal allergies, allergic to dust and cigarettes, hypothyroidism.			1						1	Fatigue; Headache; Malaise; Pharyngolaryngeal pain; Rhinitis	FLUN3~MEDIMMUNE VACCINES, INC.~500336P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229416	11/18/2004	LA	25.0	25		F	11/04/2004	1-2 hours after admin of Flu shot, itching and rash to left arm, face, neck and back. Raised red rash.									Y	11/01/2004	11/01/2004	0		PVT	PUB	Cortisone injection 2 wks prior, Advil (4x day), Folic acid prenatal, Tylenol arthritis,	NONE	Rheumatoid Arthritis; Codeine			1						1	Rash maculo-papular; Rash pruritic	FLU3~SANOFI PASTEUR~U1439AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229417	11/18/2004	NY	1.47	1	.5	M	11/13/2004	Hives noted 24 hrs after admin of vaccine. Treatment: Benadryl									Y	11/11/2004	11/12/2004	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Urticaria	DTAP~SANOFI PASTEUR~C1996AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1516AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A57561B~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0229418	11/18/2004	MN	29.0	29		F	11/01/2004	Chills, fever 101.8, nausea PM the evening after flu shot									Y	10/29/2004	10/29/2004	0	NONE	PUB	PVT	NONE	NONE	Allergies to Penicillin			1						1	Chills; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~U1455BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229419	11/18/2004	MI	84.0	84		F	11/10/2004	Vaccine given11/04/2004. Pt states she felt numbness and tingling in legs later same evening. Went to Dr office 11/05/2004 with weakness. Dr states symptoms started to resolve 11/06/2004.				Y					N	11/04/2004	11/05/2004	1	MRI on 11/15/2004	OTH	PVT	Heart Retrobid, Madisertic, Vitamins		Heart Disease			1						1	Asthenia; Hypoaesthesia; Paraesthesia	FLU3~SANOFI PASTEUR~U1479AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229432	11/19/2004	WI	91.0	90		M	11/17/2004	From initial information received on 11/15/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 90 year old male patient received FLUZONE, lot number U1458AA, administered IM in the left arm on 10/20/04. Two weeks later on 11/4/04, the patient developed a full body rash. He was hospitalized for two days. He was seen by a dermatologist and an allergist and prescribed Zyrtec, Singulair and Prednisone. It is unknown if the patient recovered from this event.				Y	Y	2			U	10/20/2004	11/04/2004	15		UNK	UNK	Warfarin; Synthroid		The patient has a history of degenerative joint disease, atrial fibrillation, hypothyroidism, congestive heart failure, cerebrovascular accident with left hemiparesis and chronic dermopathy. He did not have any illness at the time of vaccination.		200403656	1						1	Rash	FLU3~SANOFI PASTEUR~U1458AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0229435	11/19/2004	WY	77.0	76		F		Erythema, blisters, pain, inflammation, itch. Benadryl. Doctor visit. Antibiotic Biaxin XL 500 qdx7days. Kenalog cream, ice packs. Follow up 11/22/2004: treated as an injection site reaction that evolved into a cellulitus.									Y	10/22/2004	10/29/2004	7		UNK	PVT	Demadex, Mirelax, Lezapro, MVI, MS, MicroK, Slow Mag 2, Macroloid, MS Centin, Tylenol	Chronic UTI	Allergies to PCN, Levaquin. Diagnosed: Extra-ventricular obstructive hydrocephally.  ; venous insufficiency, CHF, Diabetes Type II, peripheral neuropathy.			1						1	Blister; Cellulitis; Erythema; Injection site inflammation; Injection site reaction; Pain; Pruritus	FLU3~SANOFI PASTEUR~U1440AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229436	11/19/2004	IL				U	10/22/2004	Syringe nipple and luer-lock connector broke from syringe barrel. In one instance the break occurred at the time of attachment of safety needle to syringe. In two occurrences the break occurred when safety device on needle was activated after injection was completed.									U		10/21/2004		Occurred in three syringes of approximately 600 doses administered.	UNK	UNK						1						1	Medication error	FLU3~SANOFI PASTEUR~U13394AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229437	11/19/2004	TN				F	10/22/2004	Patient receive Fluzone vaccine at 1:20pm , came up to counter complaining of intense itching and redness at site.									U	10/22/2004	10/22/2004	0		UNK	UNK						1						1	Injection site erythema; Pruritus	FLU3~SANOFI PASTEUR~U1504AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229438	11/19/2004		43.0	43		U		Employee (patient) received flu vaccine in left arm (deltoid), returns with 50 mm (at its longest points) red raised reaction. Complaints of soreness, skin taut, arm aching during night. Temp 97.8.									U	10/22/2004				UNK	UNK						1						1	Dyskinesia; Erythema; Injection site swelling; Pyrexia; Skin reaction; Tenderness	FLU3~SANOFI PASTEUR~U1455CA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229439	11/19/2004	VA		1	.6	M	11/10/2004	Received Dtap, influenza, Prevnar on 11/8/04. Called triage on 11/10/04 complained of slight rash and redness of area, no swelling T 99 degrees (R).									Y	11/09/2004	11/10/2004	1		PVT	PVT	Singulair	Otitis Media	Eggs			1						1	Erythema; Pyrexia; Rash	DTAP~SMITHKLINE BEECHAM~632B2~4~IM~LL~DTAP (INFANRIX)~1|FLU3~EVANS VACCINES~U1383AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PNC~PFIZER\WYETH~A67180A~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0229440	11/19/2004	FL	1.14	1	.1	F		Received flu shot (dose 2; 1st dose 10/13/2004: no problems) in AM 11/11/04. Fine all day until 6pm. Became quieter than usual. Temp 102 degrees R. No appetite. Injection site slightly swollen. No redness, no warmth. Not hard. Tylenol given 9:00p T 103 R. Mom called doctor. Additional Tylenol and Children's Advil given. No runny nose and cough. Not pulling at . No vomiting or diarrhea. 103 degree temp  99R. 11/12/2004 early am. T101 degrees R by that pm, acting fine, fever gone. 11/15/04 fine. No fever.									Y	11/11/2004	11/11/2004	0		PVT	PVT		NONE	NONE			1						1	Abnormal behaviour; Anorexia; Injection site swelling; Pyrexia	FLU3~SANOFI PASTEUR~U1476AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229441	11/19/2004	MD	59.0	59		F	11/16/2004	After receiving shot, pt went to cafeteria to get lunch. After eating started having pains under left breast, she originally thought was gas pain. Pain was slightly stabbing in nature. Heart was pounding, took her BP and pulse. BP was 140/80 pulse was 153 beats/min, went to ER diagnosed with A-fibrillation and was admitted.				Y	Y	4			Y	11/09/2004	11/09/2004	0	Thyroid hormone test were abnormal as per patient. To be scheduled for thyroid scan and thallium stress test.  From information recieved from medical records thyroid level increased. msv	PUB	UNK	Calcium; Aspirin; Lipitor; Fosamax; Multivitamin	NONE	High cholesterol; History of heart palpitations			1						1	Atrial fibrillation; Chest pain; Heart rate increased; Laboratory test abnormal; Palpitations	FLU3~SANOFI PASTEUR~U1641CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0229442	11/19/2004	NY	83.0	83		F	11/12/2004	Patient developed 1/2 dollar sized swelling to left deltoid. Hard on palpation. (no redness). Influenza given in left arm. Assessed by doctor, medical resident.									Y	11/12/2004	11/12/2004	0	Instructed to apply ice packs and return to ER if SOB or rash, redness develops	PUB	PVT	Evista, Synthroid, Cozaar, Caltrate, HCTZ, Fosomax, Folic Acid		Allergic to Benadryl, Ampicillin, Codeine			1						1	Injection site induration; Swelling	FLU3~SANOFI PASTEUR~41498AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0371P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0229443	11/19/2004	IL	0.34	0	.3	F	11/12/2004	Flu vaccine administered to infant leg from 6 months of age. No apparent sequelae or complication.									U	10/04/2004				PVT	UNK		NONE	NONE			1						1	Unevaluable event	DTAP~UNKNOWN MANUFACTURER~~UNK~~~DTAP (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1410BA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~UNKNOWN MANUFACTURER~~UNK~~~HIB (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|PNC~PFIZER\WYETH~~UNK~~~PNEUMO (PREVNAR)~1	USA		Influenza
0229444	11/19/2004	OR	1.0	1	.0	M	11/10/2004	Baby developed lethargy, sudden fever (101 degrees), irritability within 2-4 hours of vaccines. No associated signs or symptoms to localize what infectious agent may be causing symptoms. Symptoms persisted 11/8 pm (day of vaccination) through today 11/10 pm 48 hours, though fever <100 today and not as listless. Still cranky. No localized reaction to any inoculation site. Normal PE today.									Y	11/08/2004	11/08/2004	0	Complete hx and PE: no labs	PVT	PVT	Tylenol prn on 11/8pm and 11/9	NONE	NONE			1						1	Irritability; Lethargy; Pyrexia	FLU3~SANOFI PASTEUR~U1414AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE436AA~4~~LL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0315P~1~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A671808~4~~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0590P~1~~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0229445	11/19/2004	MA	78.0	78		M		Rapid heart beat. Dizziness, Weakness. Started 1 hour after shot. Lasted 8 hours . Now okay.									Y	11/01/2004	11/01/2004	0		PUB	PUB	NONE	NONE	NONE			1						1	Asthenia; Dizziness; Tachycardia	FLUX~UNKNOWN MANUFACTURER~~7+~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0229446	11/19/2004	VA	3.0	2	.6	M	11/09/2004	Diffuse blanching erythematous macular rash. Some petechia on back. Multiple petechial palate. Platelet count 134: CBC drawn. Observation: pt improved.									Y	10/25/2004	11/03/2004	9	CBC: platelet 134	PVT	PVT	Tylenol	Chronic SOM				1						1	Injection site discolouration; Petechiae; Rash erythematous; Rash macular	DTAP~SANOFI PASTEUR~C2104AA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~41383AD~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~U2231AA~4~IM~LL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0044P~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A79659D~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0229447	11/19/2004	IA	79.0	79		M	11/16/2004	Within 24 hours developed burning/ redness at injection site. Then blisters developed. Called MD 10/18/04 and Prednisone oral prescribed x 6 days and Triaminoclone cream. Blisters and swelling from shoulder to thumb progressed. Client not seen by doctor until 11/10/04. Health department notified 11/15/04.									N	10/14/2004	10/14/2004	0		PUB	PVT	UNK	NONE	Shrimp			1						1	Blister; Injection site erythema; Skin burning sensation; Swelling	FLU3~SANOFI PASTEUR~U1411AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229448	11/19/2004	OH	48.0	48		F	11/12/2004	I'm experiencing itching, tingling sensation with pain in left arm. Started the following week after shot and I'm still having it. It feels like it's in a nerve or something (the pain).									N	10/29/2004	11/05/2004	7	NONE	PUB	PVT	Glucophage 500 mg BID Montrin	NONE	Diabetes; Sulpha allergies; Sinusitis			1						1	Neuralgia; Pain; Paraesthesia; Pruritus	FLU3~SANOFI PASTEUR~U1452AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229449	11/19/2004	CA	1.31	1	.3	M	11/15/2004	11/15: Child developed temperature and seizure like stiffness. Child was taken to local hospital and given rectal Tylenol and given two shots of abx. Mother was told that child had an ear infection. Child was kept in hospital for a few hours for observation then released home with rx of amoxicillin. Mother was instructed to follow up with private MD after child finishes abx. Mother states child is doing fine. No more temperature today. Medical Records received on 1/13/2005 states pt experienced vomiting and otitis media.				Y					Y	11/09/2004	11/09/2004	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Convulsion; Musculoskeletal stiffness; Otitis media; Pyrexia; Vomiting	DTAP~SANOFI PASTEUR~U1300AA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1403AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE275AA~4~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A79659C~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0229474	11/19/2004	WI	1.05	1	.0	M	11/19/2004	1 INCH DIAMETER WARM ERYTHEMATOUS RING ON L ARM NEAR SITE WHERE VARICELLA VACCINE WAS GIVEN.  PER MOM APPEARED ABOUT 5 HOURS AFTER ADMINISTRATION.									U	11/16/2004	11/16/2004	0	N/A	UNK	UNK	NONE	NONE	NONE			1						1	Injection site erythema; Injection site warmth	DTAP~SANOFI PASTEUR~U1316BA~3~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1437AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0313P~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PPV~PFIZER\WYETH~A744003~3~IM~RA~PNEUMO (PNU-IMUNE)~1|VARCEL~MERCK & CO. INC.~0281P~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0229476	11/19/2004	MO	86.0	86		F	11/10/2004	Client started breaking out in hives on Saturday AM, 11/6/04, after receiving the flu shot.  No sign of respiratory diffucilties. Hives were primarly on face, around mouth, and at hairline. She was seen by physician on 11/8/04 and received a Cortisone shot. Client was seen again on 11/9/04 for a second injection. Now doing better.				Y					Y	11/05/2004	11/06/2004	1		UNK	UNK	Celebrex, Lorezapam, Celexa, baby ASA		Allergy cat/dog hair, dust, mold		MO200452	1						1	Urticaria	FLU3~SANOFI PASTEUR~U1380AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229479	11/19/2004	MA	45.0	44		F	11/19/2004	Received vaccine Nov. 16th, 2004. Two days later developed a fever and arm that was injected had large swollen red area, whole arm was warm. I went back to the clinic and was told my Doctor would have to check it. I went to my Doctor and was told it was an infection, cellulitus. Given a course of anti-biotics.									U	11/16/2004	11/18/2004	2		UNK	UNK						1						1	Cellulitis; Feeling hot; Infection; Injection site erythema; Injection site swelling; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0229480	11/19/2004	KY	85.0	84		F	11/19/2004	Patient became dizzy, c/o feeling hot and weak immediatly after receiving Influenza vaccine. Vital signs 140/70 BP and pulse 80, random blood sugar 66. Patient continued to c/o weakness, syncope and feeling hot apprximately 20 to 25 minutes and was transfered to the E.R. by ambulance. Pt was discharged in stable condition the same day from the E.R. with the Diagnosis of adverse reaction to Influenza vaccine.				Y					Y	11/19/2004	11/19/2004	0		UNK	UNK		None per patient	Congestive heart failure, low potassium, pacemaker			1						1	Asthenia; Dizziness; Feeling hot; Syncope	FLU3~SANOFI PASTEUR~UA1561AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229488	11/19/2004	CA	1.83			M	11/20/2004	Within 1 hr of receiving Flu Vac pt developed hives on face (cheeks). No respiratory distress. Addendum 11/29/04: hives continued, still had them on 11/24/04 and pt vomited x 2 on 11/24/04; continuing with Benadryl q 5-6hrs.									Y	11/20/2004	11/20/2004	0	NONE	PVT	PVT	NONE	Cold sxs x 3 1/2 wks: loose cough residual	RSV at 4 weeks of age, wheeze with cold sxs on occasion.			1						1	Urticaria; Vomiting	FLU3~SANOFI PASTEUR~U1476AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229489	11/19/2004	IL	1.01	1	.0	F	10/12/2004	25mm red raised with center vesicle with small vesicle and center with scale in center small indurated area in arm.				Y					U	09/27/2004	10/12/2004	15		PVT	PVT						1						1	Blister; Injection site induration; Injection site mass; Rash maculo-papular	FLU3~SANOFI PASTEUR~U1410BA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A57559C~3~IM~~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0475N~1~SC~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0229490	11/19/2004	KS	79.0	79		F	11/15/2004	Red, sore arm at injection site; painful to use. No treatment.									Y	11/04/2004	11/05/2004	1		PVT	PVT	NONE		NKDA			1						1	Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U1462AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0529M~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0229491	11/19/2004	KS	86.0	85		M	11/15/2004	SQ injection site. Left arm very sore for 3-4 days. No treatment.									Y	10/26/2004	10/27/2004	1		PVT	PVT	NONE		PCN			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U1462AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0513P~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0229492	11/19/2004	NC	11.0	11		M	10/28/2004	Mother reports about 5 PM noticed swelling left arm from shoulder about midway to elbow. Arm very sore. By 10/27 PM, swelling gone and not sore. Took Motrin. On 10/27 at 8:30 PM, complained of lips numb and noticed lip very swollen and face puffy. Seen in ER. Given Benadryl and not any better 10/28.				Y					Y	10/26/2004	10/26/2004	0	NONE	PUB	PUB	Zopenex; Advair; Albuterol;	Wheezing	Intussusception of bowel as baby; Questionable egg allergy; Asthma; Allergy to Amoxicillin and Zithromax.		NC04121	1						1	Hypoaesthesia; Oedema peripheral; Pain; Swelling face	FLU3~SANOFI PASTEUR~U1417AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229493	11/19/2004	MA	76.0	76		F	11/19/2004	Patient complained of swelling, redness, pain at injection site right deltoid. Right upper arm warm. Questionable cellulitis. Complained of chills. Patient applied warm heat; improvement noted. Cellulitis resolving.									Y	11/15/2004	11/15/2004	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Cellulitis; Chills; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1519AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229494	11/19/2004	MA	77.0	76		F	11/19/2004	Patient complained of pain, redness at right deltoid site. Then itching as evening came. She applied ice pack. Pain, redness and itching resolved.									Y	11/15/2004	11/15/2004	0	NONE	PUB	UNK	NONE	NONE	NONE			1						1	Injection site erythema; Injection site hypersensitivity; Injection site pain; Pruritus	FLU3~SANOFI PASTEUR~U1519AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229495	11/19/2004	VA	65.0	64		F	11/19/2004	Patient called at 12:45 to say shot site was swollen and sore. No redness, no rash or other side effects. Feeling soreness down to hand. Advised cool compress and to see doctor if worsened.									Y	11/18/2004	11/18/2004	0		PUB	PUB	Lisinopril; Prilosec; Insulin; Albuterol; Flovent; Zocor	NONE	Diabetes; Emphysema; Asthma			1						1	Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1528AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229496	11/19/2004	FL	51.0	50		F		Received flu shot on 10/29/04. Developed pain right after shot; noted a small ball under skin. Applied ice for several days; pain decreased after a week. Now (11/18/04) pain is worse and have slight traction elevating arm. Overall range of motion and pain is worse.				Y					U	10/29/2004	10/29/2004	0	Pain/injury right arm.	PVT	PVT		Pain at site of injection.	Allergy to codeine.			1						1	Injection site mass; Injection site pain; Injury; Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~U1438AA~6~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229497	11/19/2004	IL	58.0	58		M	11/19/2004	On 11/16, patient called doctor complaining of redness, swelling, and pain at site of injection. Patient asked to come to office to be evaluated. Doctor confirmed that there was a rash in area, swelling and tenderness in upper arm where flu vaccination was given. Redness on deltoid area. Swelling extends from forearm to dorsum of arm. Doctor considered as unremarkable the site of pneumonia injection. Doctor reports that patient did not have any chest pain, shortness of breath, wheezing, fever, chills, or complained of congestion. Doctor recommended rest, elevation and ice packs and taking Vicodin, but not sure whether patient actually took medicine. Patient status has been followed by phone. Progressively has improved; redness has decreased an no pain reported.				Y					N	11/15/2004	11/16/2004	1		PVT	PVT	Aspirin; Hyzar; Pasol CR; Protonics; Glucophage; Lipitor	NONE	Peptic ulcer disease; Bladder cancer; Hypertension; Diabetes; Degenerative joint disease; Rhinitis; Doctor reports that Procardia caused tachycardia.			1						1	Injection site erythema; Injection site pain; Injection site rash; Injection site swelling	FLU3~SANOFI PASTEUR~U1458AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0229498	11/19/2004	KY	4.0	4		M	11/19/2004	Left arm severely swollen elbow up to shoulder. Redness.				Y					Y	11/05/2004	11/06/2004	1		PVT	PVT		NONE				1						1	Erythema; Oedema peripheral; Erythema; Oedema peripheral	DTAP~SANOFI PASTEUR~C2044AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1380AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1040~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1039N~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|DTAP~SANOFI PASTEUR~C2044AA~5~IM~LA~DTAP (DAPTACEL)~2|FLU3~SANOFI PASTEUR~U1380AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|IPV~SANOFI PASTEUR~X1040~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~2|MMR~MERCK & CO. INC.~1039N~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~2	USA	Emergency room visit	Influenza
0229499	11/19/2004	KS	67.0	67		F	11/19/2004	My shoulder has remained sore since the flu vaccine was given. It seems to be getting better but is still sore. I had never had a reaction to any flu vaccine I received.									N	10/01/2004	10/01/2004	0		OTH	OTH						1						1	Pain	FLU3~SANOFI PASTEUR~U1440AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229481	11/21/2004	TN	67.0	66		M	11/21/2004	Right arm pain since 11-11-04, had fever in arm until 11-20-04. No neuropathy. Treated with heat to arm after fever subsided and ibuprofen.									N	11/11/2004	11/11/2004	0		UNK	UNK	Zocor 40mg 1 PO q d, Diovan 25mg 1 Po q d, Bextra 20mg 1 Po qd, DCN100 1 PO BID, Vit C 500mg 1 PO qd, MVI 1 PO qd	none	NKDA, HTN, Hyperlipidemia, OA			1						1	Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1518AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0228886	11/22/2004	TX	5.0	5		M	11/16/2004	That evening, started having high fevers. Thursday, fevers still lasting and body aches. Friday, still fever, body aches, and late Friday had first seizure then rushed to hospital. Then brain swelling and more seizures. Follow up 02/11/05: Patient seen by neurologist, diagnosis ADEM vs Encephalitis. Main symptoms: Sinus infection, Seizure, Fever and encephalopathy. Symptoms started 4 hours following vaccination. No history of seizures prior to this event. Very involved case. Follow up report received on 02/03/2005 indicates patient still has not recovered.  He has severe brain damage and cannot talk, is totally dependent on parents for everyday tasks such as eating, dressing, grooming, etc.  Has ADEM which is a brain disorder (acute desseminated encephalo mylopathy), has ADD (attention deficit disorder), and sensory integration disorder, and his mobility is also limited.  Additional information from other corresponcance adds aphasia, drooling and papilledema on 01/18/05			Y	Y	Y		Y	Y	N	10/27/2004	10/27/2004	0	MRI; CT Scans; Infectious disease doctor; other doctors. From other correspondance 01/18/05 CSF abnormal, leukocytosis, bacterial infection.	PUB	OTH	NONE	NONE	Asthma			1						2	Anorexia; Aphasia; Bradycardia; Convulsion; Delirium; Encephalitis; Hypoxia; Infection; Intracranial pressure increased; Meningitis; Mental retardation severity unspecified; Nervous system disorder; Nystagmus; Oedema; Pyrexia; Aphasia; Bacterial infection; Brain oedema; CSF test abnormal; Convulsion; Encephalopathy; Movement disorder; Pain; Papilloedema; Pyrexia; Salivary hypersecretion; Sinusitis; White blood cell count increased	FLU3~SANOFI PASTEUR~UI458AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1458AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0229482	11/22/2004		23.0	23		F	11/22/2004	NUMBNESS AND WEAKNESS IN SMALL FINGER AND RING FINGER ON LEFT HAND.  GOT THE SMALLPOX VACCINE IN THE LEFT DELTOID. I, THE PHYSICIAN, HAVE DONE A COMPLETE PHYSICAL EXAM AND HAVE NOTED A CERVICAL NERVE 8 RADICULOPATHY.				Y					N	11/15/2004	11/20/2004	5	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Hypoaesthesia; Muscular weakness; Neuropathy	FLU3~PFIZER\WYETH~U1457A~3~IM~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|SMALL~PFIZER\WYETH~4020072~1~ID~LA~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0229519	11/22/2004	UT	28.0	28		M	11/22/2004	Pt. Received vaccines (HIB, Influenza, Pneum. 23, approximately 1030 am on 11/18/2004. He returned later that afternoon at approximately 400pm and stated he had felt sick since returning home.  The symptoms he felt were short of breath, heavy chest, dizzy, nauseated. He decided he better return when the symptoms did not go away. Upon presentation and assesment of symptoms, it was determined to give the patient 3 tsp. Benadryl by mouth.  V/S assessed, and patient discharged with instructions to go directly to the local Emergency Room, or contact doctor with further concerns. Secretary also stated he showed her his Left arm where pneumonia and influenza were given was red, hot, and swollen within that 5 1/2 hour period of time.  When I viewed his arm however, either the sleeve was not lifted high enough, or his fingers were covering the site.  Pt. stated his arm was very sore, but no local reactions noted as described by secretary.   Note:  pt. requested the HIB vaccine, stating he had his spleen removed, and should have vaccine every 5 years, and was due for the vaccine at this point.									Y	11/18/2004	11/18/2004	0	none	UNK	UNK	none	none	Spleen removed within the last 10 years			1						1	Chest pain; Dizziness; Dyspnoea; Injection site erythema; Injection site swelling; Injection site warmth; Malaise; Nausea	FLU3~SANOFI PASTEUR~u1556aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~ue193aa~5~IM~RA~HIB (ACTHIB)~1|PPV~MERCK & CO. INC.~0863n~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0229520	11/22/2004	MD	56.0	56		F	11/22/2004	Client notice an area of redness, slight swelling, and tenderness at site of influenza vaccination.  About the size of a nickle with a tiny pinpoint in the middle.  No recollection of a bug bite.  Advised client to call PMD if symptoms worsened or if she had futher concerns.  This writer will apprize health officer. Please note: administered via Bioject system.									U	11/08/2004	11/22/2004	14		UNK	UNK	Folic acid, prinivil, allegra, nexium, desyerl, soma, atenalol, mobic, zantac, ativan, darvacet, quinine sulfate, triamcinolone acetone cream, ibuterol inhaler, lidoderm patches, benedryl, vitamin E.	No.	Lupus (not active presently), sarcoidosis, hypertension, psoriasis, fibromyalgia.			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1479AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229521	11/22/2004	CO	13.0	12		M	11/22/2004	PT RECEIVED FLUMIST.  THE FOLLOWING DAY, PT AWOKE IN AM WITH BLISTERS ON TOP OF NOSE AND AROUND LEFT EYE.  PT FELT WELL WHEN WENT TO BED.  PT FEELS BLISTER HAS GOTTEN BIGGER AND ONE POPPED AND OOZED CLEAR LIQUID.  PT DENIES ANY PAIN OR BURNING INSIDE NOSE; NO FEVER, ST, COUGH, RUNNY NOSE OR ACHINESS.  TOP OF NOSE WITH 2 LG 4-6 MM BLISTERED LESIONS, 3 DISCRETE VESICULAR LESIONS AROUND LEFT EYE, 2 BELOW EYELID AND 1 LATERAL, ABOVE CORNER OF EYE EACH ABOUT 2-3 MM.  INSIDE NOSE WITH GENERALIZE REDNESS OF MEDIAL SEPTUM, BUT NO BLISTERS, SCANT MUCOUS. PLAN - KEEP CLEAN WITH GENTLE WASH, CAN APPLY NEOSPORIN.  MOC TO CALL IF ANY PAIN OR BLISTERING IN EYES, SIGNIFICANT SPREADING OR FEVER.  ADDENDUM - MOC STATES ALL BLISTERS HAVE POPPED.  LOOKS LIKE RED BLOTCHES WITH NO DRAINAGE.  MOM STATES SHE THINKS PT TOOK KLEENEX FROM YESTERDAY, THAT VACCINE HAD DRIPPED ON KLEENEX, AND THEN PT WIPED FACE WITH KLEENEX AROUND EYE AREA AND ON NOSE.									U	11/17/2004	11/18/2004	1	NONE	UNK	UNK	CONCERTA 36 MG QAM	NONE - CHILD FELT WELL	NKDA, ATTENTION-DEFICIT DISORDER			1						1	Blister; Erythema; Skin ulcer	FLUN3~MEDIMMUNE VACCINES, INC.~500336p~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229523	11/22/2004	MD	63.0	63		F	11/22/2004	Client received flu Vaccine in l Deltoid on 11/15/04.  About 2 hours post vaccine client experienced numbness in l thigh.  Problem persised and worsened. Consulted with primary provider on 11/18/04. He spoke to a neurologist who stated that the client had a femerol neuropathy due to the flu vaccination. Paralysis began lifting on 11/19/04 and was totally gone by Sunday Nov 20, 2004. Medical records state Pain as s/s.									Y	11/15/2004	11/15/2004	0	NONE	UNK	UNK	Nil	Nil	Quinine Allergy Note client had flu vaccine in 2002 ans 2003 with no side effects. Medical record states history of hyperlipedemia.			1						1	Hypoaesthesia; Neuropathy; Pain; Paralysis	FLU3~SANOFI PASTEUR~U1459AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229525	11/22/2004	VA	53.0	53		F	11/22/2004	MOTHER REPORTS THAT SHE NOTED RED FLAT RASH ON PATIENT'S BACK, CHEST AND LEGS AFTER SHOWER ON PM AFTER RECEIVING FLU VACCINE IN MORNING.  PER MOTHER'S HISTORY, THE RASH RESOLVES AND RETURNS, SOMETIMES ON UPPER LEGS OR LOWER LEGS.  PHYSICIAN RECOMMENDED STOPPING ALL MEDICATIONS AND RESUMING SLOWLY AFTER RASH RESOLVES									U	11/17/2004				UNK	UNK	CALCIUM 600 & MINERALS & VIT D, VIT.C-500MG, BUDEPRIONSR 150 MG STARTED 11/11/04 CHANGED FROM WELLBUTRION, KLOR-CON 10 MG, NORVAST 5 MG., FUROSEMIDE 20 MG, EACH DAILY MEDS	NONE	MENTAL RETARDATION, CEREBRAL PALSY, DIASTOLIC DYSFUNCTION OF HEART			1						1	Erythema; Rash	FLU3~SANOFI PASTEUR~U1417AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229526	11/22/2004	IN	60.0	60		F	11/22/2004	Patient developed golf ball sized knot with redness surrounding the injection site.  Patient complained site was painful and hot that evening.  Ice applied to site the next day per doctor.									Y	10/04/2004	10/04/2004	0	N/A	UNK	UNK	Premarin, Paxil, Detrol, Prevacid, Volmax, Synthroid	None	Depression, GERD, Hypothyroidism			1						1	Injection site erythema; Injection site mass; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U1378AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0512P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0229528	11/22/2004		26.0	26		M	11/22/2004	26 yowm presented 7 days post SPV with ant chest pain, worse w/ each heart beat, improved leaning forward, worse leaning backward, worse with deep breathing.  Denies SOB. States started 3days prior, seen in ER w/ non-specific ST elevation.  Pt returned w/ worsening chest pain & found to have pan ST elevation with PR shortening.  CPK elevated 1461, MB>80, Troponin 23.5.  Pt transferred to 121 for admission, monitoring & cardiac echo.					Y				U	11/13/2004	11/20/2004	7		UNK	UNK						1						1	Blood creatine phosphokinase increased; Chest pain	FLU3~PARKDALE PHARMACEUTICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1	USA	Hospitalisation	Influenza
0229529	11/22/2004	CA	68.0	67		F	11/22/2004	Slight swelling without redness at site of injection.  Patient complains of pain radiating to shoulder and neck.									Y	11/03/2004	11/04/2004	1		UNK	UNK						1						1	Injection site swelling; Neck pain; Shoulder pain	FLU3~SANOFI PASTEUR~U1519AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229531	11/22/2004	MN	7.0	7		M		This is a serious study case from a physician in the USA who reports WHEEZING. The reporter determined the events to be possibly related to FluMist vaccination. A physician reports a patient experienced wheezing, considered medically important (OMIC), after receiving FluMist as a participant on a study. On 10/26/04, a 7 year old male received FluMist vaccination. On 10/27/04, the patient developed a mild sore throat in the evening. On the morning of 10/28/04, the patient continued to have a sore throat in addition to a temperature of 101 degrees F and mild nausea. All of the symptoms resolved by noon on the same day, 10/28/04. He remained asymptomatic until the afternoon of 10/30/04 when he developed wheezing and mild shortness of breath. At that time, he had no fever and no other respiratory illness symptoms. His parents took him to the emergency department later that day. He was treated in the ED with a nebulizer treatment to which he responded well. He was sent home with a prescription for albuterol inhaler. The parents of the patient have been giving him albuterol four times daily. The patient has a cough but no other symptoms. The mother anticipates the patient will be able to discontinue albuterol within the next two days and will follow up with their family doctor as needed. The patient's clinical outcome is unknown.									Y	10/26/2004	10/27/2004	1		PUB	OTH	Concomitant drugs not reported.		2003: One episode of medically attended wheezing for which patient was treated with albuterol for 1.5 days with resolution of symptoms.		MEDI0002390	1						1	Cough; Dyspnoea; Nausea; Pharyngolaryngeal pain; Pyrexia; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500338P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229544	11/22/2004	MI	80.0	79		F	11/08/2004	Complaints of nausea, dry heaves, diarrhea, feeling very weak. Said she started to itch; noticed hives on arms, stomach, back and inside part of legs. Hives were oblong in shape and got very big. Husband called doctor; instructed to call EMS and transported to hospital. Discharge Summary received on 1/12/2005 states gastroenteritis, syncope and dehydration.				Y	Y	1			Y	11/03/2004	11/03/2004	0	Blood test drawn hospital nasal smear at hospital. Discharge Summary received on 1/12/2005 states lab test abnormal.	PUB	UNK	Tenormin; Lotensin; Ecotrin; Hydrochloride	NONE	Chocolate; PCN; Detrol; Elavil; Microdantin; Cine; Keflex; Celebrex; Lactose intolerant. Discharge Summary received on 1/12/2005 states hypertension and atrial fibrillation. Medical Records received on 1/12/2005 states hypercholesteroemia and urinary tract infection.		MI2004060	1						1	Asthenia; Dehydration; Diarrhoea; Gastroenteritis; Nausea; Pruritus; Retching; Syncope; Urticaria	FLU3~SANOFI PASTEUR~U1478AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0229549	11/22/2004	NJ				U		Seizure, developed fever 11/09/2004. Medical Record received on 1/12/2005 states dizziness, nausea, and lethargy.									Y	10/29/2003	11/08/2003	10		PVT	PVT		NONE	Left pulmonary value stenosis 2A50			1						1	Convulsion; Dizziness; Lethargy; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~U1097AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229550	11/22/2004	SC		11		F	11/18/2004	Swollen, tender, hot to touch. Left thigh at site of PPV 23 got better with ice pack and 2 doses daily of Clavix and Singulair in 48 hours.				Y					Y	11/11/2004	11/11/2004	0		PVT	PUB		NONE	Asthma/ Allergies			1						1	Feeling hot; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U14539AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0656~UNK~~RL~HIB (PEDVAXHIB)~1|IPV~SANOFI PASTEUR~X1038~UNK~~RL~POLIO VIRUS, INACT. (IPOL)~1|PPV~MERCK & CO. INC.~0685N~1~~LL~PNEUMO (PNEUMOVAX)~1|VARCEL~MERCK & CO. INC.~1247N~UNK~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0229551	11/22/2004	VA	76.0	76		F	11/15/2004	Left arm/ neck/ back pain 2 days after injection. Elevated BP 2 days after shot.									N	11/10/2004	11/12/2004	2	CBC/ sed rate : WNL 11/12/2004	PVT	PVT	HCTZ/ Prempro/ Levoxyl	NONE	Phenobarbital/ HTN/ Hypothyroidism			1						1	Back pain; Condition aggravated; Hypertension; Myalgia; Neck pain	FLU3~SANOFI PASTEUR~U1500AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229552	11/22/2004	TN	69.0	68		M	11/17/2004	Complaints of site tenderness, redness and warmth. Complaints of soreness in lungs, denies any cough. Received po on 11/17/04 and states symptoms mostly subsided now.									Y	11/10/2004	11/11/2004	1		PUB	PUB		NONE	UNK			1						1	Chest pain; Injection site erythema; Injection site reaction; Injection site warmth; Tenderness	FLU3~SANOFI PASTEUR~U1518AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229554	11/22/2004	ND	1.11	1	.1	M	11/11/2004	The day after the 0.25cc Influenza vaccine was given, the child started breaking out with a red raised rash at the injection site which gradually progressed to his whole body. Parents did not call the doctors office until 11/11/04. Gave Benadryl and the rash went away.									Y	10/19/2004	10/30/2004	11		PVT	PUB		NONE	NONE		ND0423	1						1	Erythema; Injection site reaction; Rash; Rash erythematous	FLU3~SANOFI PASTEUR~UE1342AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229555	11/22/2004	FL	80.0	80		F	11/18/2004	11/04/04: 7pm fever arm was red. Hot to touch. Swelling, painful. 11/10/04 : fever again, all day same symptoms. 11/11/04: went to doctor, prescription issued for Cephalexin 500 mg (Sub-Keflex)									Y	11/09/2004	11/09/2004	0	NONE	UNK	UNK						1						1	Erythema; Feeling hot; Pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~1579AM~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~B7069~1~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0229557	11/22/2004	MI	26.0	25		F	11/05/2004	Received flu vaccine 11/5/04 approximately 9:15a. Stated that within the hour, began experiencing severe leg pain. Call received at 10:30 AM. Pain scale to 1-10 is at an 8:11:30 am.									U	11/05/2004	11/05/2004	0		PUB	UNK	Prednisone, Zonegrane	Addison's Disease	Reflex, Cappra, Latex and Codeine , Dilaudid	nausea, vomiting~Hib (no brand name)~1~24.00~In Patient	MI2004062	1						1	Myalgia	FLU3~SANOFI PASTEUR~APCOU1579AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229558	11/22/2004	MI	54.0	54		F	11/05/2004	Client received flu vaccine 11/4/04 at approximately 12-12:30 pm. At approximately 8pm felt itching under bra line, around waist, panty line and under arms. Noticed large area of hives and red blotches. She took Benedryl (4 tsp (50mg)) and then at 10:30 pm took 25 mg. Client with slight itching today. No red blotches today. Also complained of some congestion but states no difficulty breathing.									Y	11/04/2004	11/04/2004	0		PUB	UNK	ASH, Lantus insulin, Glucotrol, Glucophage, Climan patch, Vitamins	NONE	Sinus infection 2 weeks ago: completed Z pack 2-3 weeks ago		MI2004061	1						1	Nasal congestion; Pruritus; Rash macular; Urticaria	FLU3~SANOFI PASTEUR~U1478AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229559	11/22/2004	SD	45.0	44		F	10/28/2004	Arm began to feel warm: real red. Redness kept glowing and felt hard in the middle approximate size 8x8 on 10/27/04.									Y	10/25/2004	10/25/2004	0		UNK	UNK	Advair inhaler, Praventil inhaler	NONE	Asthma		SD04026	1						1	Erythema; Feeling hot; Injection site induration	FLU3~SANOFI PASTEUR~U1425AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229561	11/22/2004	MA	1.02	1	.0	M	11/15/2004	Blanching rash starting on face to chest, back over 2-3 days, no treatment.									Y	11/04/2004	11/13/2004	9		PVT	PVT		NONE	NONE			1						1	Pallor; Rash	FLU3~SANOFI PASTEUR~U1003AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1050N~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0282P~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0229563	11/22/2004	WI	76.0	76		F	11/15/2004	Cellulitis below site: erythema. Cellulitis at Pneumovax site.				Y					Y	10/15/2004	10/20/2004	5		PVT	PVT						1						1	Cellulitis; Erythema; Injection site reaction	FLU3~SANOFI PASTEUR~~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0287P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0229564	11/22/2004	WI	67.0	67		F	11/15/2004	Cellulitis below site. Cellulitis at Pneumovax site.				Y					Y	11/02/2004	11/04/2004	2		PVT	PVT						1						1	Cellulitis; Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0213P~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0229565	11/22/2004	MA	1.58	1	.6	M	11/16/2004	Seizure with fever, 10-12 hours after PCV 7 given. Lasted around 1 min. Generalized nonfocal. Medical Record received on 1/3/2005 states pharyngitis and otitis media.				Y					Y	11/15/2004	11/16/2004	1		PVT	PUB	Singulair, Albuterol nebs prn	Medical Record received on 1/3/2005 states vomiting and rhinitis.	RAD History of treatment for Otitis			1						1	Convulsion; Otitis media; Pharyngitis; Pyrexia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~495725~4~IM~LA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0229566	11/22/2004	CO	62.0	61		F	11/09/2004	Began with hive like rash 5-6 hours following injection. Symptoms continued with rash transforming into peeling of skin (has been seen x 2 by her doctor).				Y					Y	10/16/2004	10/16/2004	0		PVT	PVT		NONE	Sulpha PCN Cephalosporins			1						1	Rash; Skin exfoliation; Urticaria	FLU3~SANOFI PASTEUR~1456AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229567	11/22/2004	AL	1.8	1	.8	M	11/12/2004	Pt received flu shot 11/8/04, returned to PCP clinic 11/10/04 with complaints of fever 104 with URI symptoms, diarrhea; given Motrin, Zyrtec, Oratuss and Viravan DM. Instructed to follow up in 2d if temp 101.				Y					U	11/08/2004	11/09/2004	1		PVT	PUB	NONE	NONE	RAD			1						1	Diarrhoea; Pyrexia; Upper respiratory tract infection	FLUX~UNKNOWN MANUFACTURER~U1404AA~UNK~~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0229568	11/22/2004	MD	66.0	66		F	11/08/2004	Received flu vaccine 11/3/04: 2pm. Later in the evening she had increased numbness of her extremities, burning, aching in every joint, chills, fever to 99 degrees. Unable to walk morning of 11/4/04. Patient had history of peripheral neuropathy since 1999. Had been in remission for 7 months: Jan 04 - Aug 04. No history diabetes mellitus. Has been tested for Guillain Barre Syndrome and Lupus, but not diagnosed. She has wheelchair and walker. Has been in wheelchair since 11/3/04. History of asthma. Allergist advised her to get the flu shot.									U	11/03/2004	11/03/2004	0		PUB	PUB	Gabitril, Neurontin, Hydrox, ADAP, Albuterol	NONE	Peripheral neuropathy, numbness and burning in upper and lower extremities and face. Medical Records received on 2/02/2005 states neuropathy.			1						1	Arthralgia; Chills; Condition aggravated; Difficulty in walking; Hypoaesthesia; Pyrexia; Skin burning sensation	FLU3~SANOFI PASTEUR~41454aa~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229569	11/22/2004	LA	81.0	80		M	11/15/2004	Blacked out. Faintly and weak. Head felt like it was spinning. Lasted about 2 minutes. Few minutes later had same symptom lasted about 2-3 minutes. About 3 days later had same symptoms uptown in store lasted about one minutes. No treatment.									Y	10/28/2004	10/28/2004	0	NONE	PUB	PUB	Aricept, Klorcon, Gemfibrozil, Flomax, Plavix, Protonix, Avandamet, Aspirin, Lasix, Lanoxin, Prednisone, Xanax, Ambien, Albuterol Sulfate Premixed with Nebulizer, C-pap with oxygen at bedtime.	NONE	Asthma, COPD, Sleep Apnea, 30% Blockage in heart Artery.			1						1	Asthenia; Dizziness; Loss of consciousness; Vertigo	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0229570	11/22/2004	WA	1.04	1	.0	F	11/15/2004	Two 5 mm and red indurated and fluctuant papular lesions at injection site. Mildly tender. Treated for cellulitis with Cephalexin x 10days.									U	11/11/2004	11/12/2004	1		PVT	PUB		Otitis Media resolving	Amoxicillin allergy: rash			1						1	Cellulitis; Erythema; Injection site induration; Injection site rash; Rash papular; Tenderness	FLU3~SANOFI PASTEUR~U1530AB~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229612	11/23/2004	KS	45.0	44		F	11/23/2004	Didn't bother me till the next day painfully as I leaned on it. Just thought is was sore, but started noticing it in exerceses, sharp pain in arm. Couldn't sleep pn left side for the pain. Decided I had better ask if it was normal after it was still bothering me for over a week. Still after 2 weeks places still sore and at times bothers me. But seems to be getting a little better now, as I don't notice it quite so much. feels like a needle is in there. Treatment with Tylenal, Motrin, Ice packs. better ofter three 1/2 weeks.									Y	10/11/2004	10/12/2004	1		UNK	UNK	None	None	None			1						1	Pain	FLU3~SANOFI PASTEUR~U1488AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229613	11/23/2004	CA	62.0	62		F	11/23/2004	Had Fluzone/pneumonia vaccine 11/19/2004(AM). That evening started feeling achy(lower back) temp went up to 103 degrees by late PM. Temp went down to 101 degrees but lasted all week-end. Did not seek medical care. On 11/22/04 red blotchy area appeared on right arm near the injection site. Client states feeling much better, but feels weak.									Y	11/19/2004	11/19/2004	0		UNK	UNK						1						1	Asthenia; Back pain; Pyrexia; Rash macular	FLU3~SANOFI PASTEUR~U1519AB~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0692P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0229615	11/23/2004	GA	7.0	6		F	11/23/2004	PT RETURNED TO CLINIC WITH SWELLING, REDNESS, AND HEAT TO SITE OF INJECTION.  SIZE OF SWELLING AND INDURATION 30X40MM.  PT RECEIVED VACCINE 11/22/04 AND REPORTED ADVERSE REATION 11/22/04.									Y	11/22/2004	11/22/2004	0	NONE	UNK	UNK		DENIES	ASTHMA			1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1439AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229617	11/23/2004	CA	51.0	50		F	11/23/2004	Had Fluzone in the AM 11/19/04. In the PM had Tetanus and pneumonia. By 7PM that evening states feeling achy and stuffy nose. Early AM 11/20/04 woke up with chills(did not take temp). Up in the morning achy all over with some nausea. By sunday 11/21/04 AM feeling better, but felt like she had been hit by a mack truck.									Y	11/19/2004	11/19/2004	0		UNK	UNK	n/a	none	NKDA			1						1	Chills; Nasal congestion; Nausea; Pain	FLU3~SANOFI PASTEUR~U1519AB~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0692P~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TTOX~SANOFI PASTEUR~Td107~1~IM~RA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0229618	11/23/2004		21.0	20		M	11/23/2004	Multiple maculopapular lesions on trunk and upper extremeties. Consistent with generalized vaccinia.				Y					U	11/04/2004	11/13/2004	9	None	UNK	UNK	none	none	none			1						1	Cow pox; Rash maculo-papular	FLU3~SANOFI PASTEUR~V1048BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4030013~1~ID~LA~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0229619	11/23/2004		20.0	20		M	11/23/2004	2 day history of rash consistent with generalized vaccinia.				Y					U	11/04/2004	11/12/2004	8	None	UNK	UNK	None	None	None			1						1	Cow pox; Rash	FLU3~SANOFI PASTEUR~V1048BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4030013~1~ID~LA~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0229620	11/23/2004	MN	74.0	74		M	11/23/2004	Hives, approx. 60 hours following vaccination.									U	11/17/2004	11/20/2004	3		UNK	UNK						1						1	Urticaria	FLU3~SANOFI PASTEUR~U1381AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229632	11/23/2004	IN	40.0	39		F	11/09/2004	Patient admitted to hospital 11/7/04 with right facial droop. Had received Pneumovax 23 on 10/07/04. Stated that 2-3 hours after vaccination, had significant arm swelling to right upper arm. Did not seek medical attention until co-worker noted right facial droop. Discharge Summary received on 1/06/2005 states Bell's Palsy, Anisocoria, elevated BP and endometrial cyst .					Y				Y	10/07/2004	10/07/2004	0		UNK	UNK						1						1	Cyst; Endometrial disorder; Facial palsy; Hypertension; Oedema peripheral; Pupils unequal; Facial palsy; Oedema	PPV~MERCK & CO. INC.~0564N~UNK~~~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U1425AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0564N~UNK~~RA~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0229633	11/23/2004	CA	50.0	50		F	11/23/2004	Patient received flu vaccine plus Remicade injections at same time. She woke the next morning with loss of strength and feeling in legs and heaviness in arms. Information from discharge summary sttes pain, difficulty urinating. msv				Y	Y	2			Y	11/09/2004	11/10/2004	1	Normal MRI brain; C-spine; Negative Lumbar Puncture. Medical Records received on 1/25/2005 states lab work abnormal. Information from discharge summary states H&H decreased, lab test abnormal. msv	PVT	PVT	Remicade; Vicodin; Folate; HCTZ; Clonazepam; Fosamax	Rheumatoid Arthritis	Flagyl; Macrodantin Information from Discharge summary states chronic obstructive lung disease, drug dependence, tobacco. msv			1						1	Anaemia; Asthenia; Dysuria; Laboratory test abnormal; Pain; Sensation of heaviness; Hypoaesthesia; Muscular weakness	FLU3~SANOFI PASTEUR~V1449AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~V1449AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0229635	11/23/2004	NJ	84.0	83		F	11/23/2004	Developed hives on shoulders and neck. Complained of severe pruritus self medicated with hazel. Did call doctor and was prescribed cortisone and something to steep. Doctor is the client's MD.									Y	11/16/2004	11/17/2004	1	States when seen by MD and he said it was an allergic reaction.	PUB	UNK						1						1	Hypersensitivity; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1532AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229636	11/23/2004	NJ	76.0	75		F	11/23/2004	Noticed rash on thighs. States it was raised: welt-like. Denies complaints of pain, burning pruritus. Called her MD and was told to apply cortisone cream. Pt denies being seen at MD office. Treatment was prescribed over the phone by MD.									U	11/22/2004	11/23/2004	1		PUB	UNK		NONE				1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~U1532AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229637	11/23/2004	MA	51.0	50		F	11/23/2004	Low grade temp 99.2 and general aches. Site warm to touch, put ice on it.									Y	11/19/2004	11/20/2004	1	NONE	PVT	PVT	NONE	NONE		low temp~Influenza (Seasonal) (no brand name)~0~49.00~In Patient		1						1	Injection site warmth; Pain; Pyrexia; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U1418AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229638	11/23/2004	AL	64.0	64		M	11/23/2004	Received flu shot 11/16/04 at 11:00 Tuesday. Did not feel good Wednesday. On Thursday had hot post nasal drip. Friday, cough , sore throat and feeling weak. Saturday's Sunday, no change. Monday cold or flu leaving.									Y	11/16/2004	11/17/2004	1		PUB	UNK	Zocar	NONE	Hay fever			1						1	Asthenia; Cough; Pharyngolaryngeal pain; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0229639	11/23/2004	MA	31.0	30		F	11/08/2004	About two hours after receiving flu vaccine employee complained of throat tightness, nausea and redness and itching of face, arms and chest. follow up: Pt seen inER and treated for acute allergic reaction. Information from medical records states allergic reaction. msv				Y					Y	10/25/2004	10/25/2004	0		UNK	UNK			Information from Medicl records states depression. msv			1						1	Erythema; Hypersensitivity; Nausea; Pruritus; Throat tightness	FLU3~SANOFI PASTEUR~41455BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229632	11/24/2004	IN	40.0	39		F	11/24/2004	2-3 hrs after vaccination patient had significant arm swelling to R upper arm. On 11-07-2004 coworkers noticed facial droop. Patient admitted 11-07-2004.					Y	3			Y	10/07/2004	11/07/2004	31		PVT	PVT		NONE				1						2	Cyst; Endometrial disorder; Facial palsy; Hypertension; Oedema peripheral; Pupils unequal; Facial palsy; Oedema	PPV~MERCK & CO. INC.~0564N~UNK~~~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U1425AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0564N~UNK~~RA~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0229653	11/24/2004	IL	55.0	54		M	11/24/2004	Onset of right face lower eye pain 11/17/04. Diagnosed with Herpes zoster 11/22/04. Severe pain, rash progressing and now vesicular, opthalmic trigeminal distribution (right side of face, nose, periorbital, and conjunctival).  Evauated by family physician and opthalmologist. On Valtrex tid for 7 days and blephamide eye ointment, and Vicodin for pain.				Y					U	11/05/2004	11/17/2004	12	Slit lamp ocular evaluation - negative	UNK	UNK	Citracal Ibuprofen prn	none	none lactose intolerance			1						1	Eye disorder; Eye pain; Herpes zoster; Pain; Rash vesicular	FLUN3~MEDIMMUNE VACCINES, INC.~500336P8~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0229654	11/24/2004	SD	42.0	41		F	11/24/2004	Achy, nausea, swelling in hands, joints ached, faint, headache hot then cold. Started feeling sick on Friday, by Monday really sick missed work. Down all weekend. Still have achy joints and headache. Reported this to employee health.									N	11/17/2004	11/19/2004	2		UNK	UNK		none	Hypothyroidism			1						1	Arthralgia; Feeling cold; Headache; Hot flush; Malaise; Nausea; Oedema peripheral; Pain; Syncope	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229665	11/24/2004	SC	38.0	37		F	11/24/2004	1 week after Flu and Sporadic pain, numbness, tingle all over body. Neurological symptoms. Darvocet, Celebrex, Elavil Rx. Follow-up received on 3/31/2005 states now diagnosed with fibromyalgia after flu vaccine.				Y					N	10/14/2004	10/14/2004	0	CBC, ANA, MRI, C Reactive Protein	OTH	PVT	Toprol	NONE	High BP			1						1	Fibromyalgia; Hypoaesthesia; Influenza; Pain; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~1462AA~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0229666	11/24/2004	OH	19.0	18		F	11/06/2004	Injection site hard, red, and indurated 2x3 warm compresses									Y	10/21/2004	10/22/2004	1	NONE	PUB	UNK		NONE	NONE			1						1	Injection site erythema; Injection site mass	FLU3~SANOFI PASTEUR~U1455CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229667	11/24/2004	OR	65.0	65		M	11/24/2004	Localized redness at inj site with slight inflammation. Fever 101. The affected inj site was the left arm.									Y	11/23/2004	11/23/2004	0		PVT	PVT		Hypertension				1						1	Injection site erythema; Injection site inflammation; Pyrexia	FLU3~SANOFI PASTEUR~U1451AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0486P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U1346AA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0229668	11/24/2004	NC	75.0	74		F	11/19/2004	Severe right shoulder, upper arm pain, could not move arm. Given Vicodin by private provider and sent to ortho, gave Prednisone taper.				Y					N	10/11/2004	10/25/2004	14	Multiple x-rays right shoulder	PUB	PUB	Vazotec 5mg	NONE	NONE		NC04123	1						1	Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U1439AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229669	11/24/2004	HI	6.0	6		F	11/24/2004	Pt is a 6 yo girl with asthma who developed fever and slight rash 5 days after receiving flu shot. No resp distress or edema. Rash described on erythematous papular over the lower extremities and trunk. Pt was reported to be ICL with URI symptoms at the time of receiving the flu shot.									N	11/16/2004	11/17/2004	1	NONE	PVT	PUB	Flonase nasal spray, Albuterol HDI	URI symptoms, cough, rhinitis	Asthma (extrinsic)			1						1	Erythema; Pyrexia; Rash papular; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~U131AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229670	11/24/2004	WI	12.0	11		M	11/22/2004	Fever to 103 x 24 hrs, malaise, 3-4mm lesion on tongue, sore throat, local pain, swelling and blotchy, blanching rash at injection site on deltoid as well as warmth. Pt was also short of breath at one point. Tylenol, Heat or cold, gentle range of motion exercises. F/u if not back to normal in 1 week.									Y	11/19/2004	11/19/2004	0	NONE	PVT	PVT	Flovent 110mcg	NONE	RAD			1						1	Dyspnoea; Feeling hot; Injection site discolouration; Injection site pain; Malaise; Oedema; Pharyngolaryngeal pain; Pyrexia; Rash macular	FLU3~SANOFI PASTEUR~U1450AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0946N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0229671	11/24/2004	MI	91.0	90		M	11/15/2004	12 hours later woke up with pruritus, 36 hours later pruritus increased, with hives all over the body. Largest hive on arm, at least 4 inches in diameter. No other problems.									Y	11/08/2004	11/09/2004	1	NONE	PUB	UNK	Nadolol, Lipitor, another B/P med					1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1579AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229672	11/24/2004		30.0			F	11/03/2004	Health care worker complained 2 to 3 hours after receiving flu injection of sudden onset of chest pains which caused hyperventilation due to anxiety caused by the symptoms. She was seen by a physician and evaluated. Vital signs were stable. After leaving work, worker state she developed hives and swelling of eyes. She was taken to ER and diagnosis was acute allergic reaction.									U		11/03/2004			UNK	UNK			Previous history of food allergies and questionable medication allergies.			1						1	Anxiety; Chest pain; Eye oedema; Hypersensitivity; Hyperventilation; Urticaria	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229673	11/24/2004	OK	88.0	88		M	11/08/2004	Swelling from injection site in Left deltoid to Left hand. Pain with ROM. Reaction to influenza vaccine.									U	10/22/2004	10/24/2004	2		UNK	UNK						1						1	Injection site oedema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0229674	11/24/2004	VA	63.0	62		F	11/18/2004	Vaccine given 11AM 11/6/2004. Overall swelling started at 1PM by 2300 swelling severe, to ER.				Y					Y	11/16/2004	11/16/2004	0		PUB	PUB		DM, HTN, CORD			VA04040	1						1	Oedema	FLU3~SANOFI PASTEUR~121528AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229675	11/24/2004	VA	52.0	51		M	11/08/2004	Sx started 1:30PM began sweating, lightheadedness, tremors of extremities, queasy, 170/88, P100, Temp 97.3.									Y	11/08/2004	11/08/2004	0		PUB	PUB	Diazepan 5mg	NONE	Toprol x L 50mg T PO/day, Zocor		VA04039	1						1	Dizziness; Hyperhidrosis; Nausea; Tremor	FLU3~SANOFI PASTEUR~U1528AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229676	11/24/2004	CA	48.0	48		F		Redness, Black and blue spots, hot to the touch, within 2 hours, after administration of injection									U	11/16/2004	11/16/2004	0		UNK	OTH	Insulin, Fentanyl, Enbrel		N K Allergies to eggs, DM, Rheumatoid Arthritis			1						1	Contusion; Feeling hot; Injection site erythema	FLU3~SANOFI PASTEUR~U1479AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229677	11/24/2004	OH	49.0	48		F	11/19/2004	Fever, muscle aches, dizziness, fogginess x 1 week.									U	11/10/2004	11/12/2004	2		PUB	PUB	Nexium, Progesterone, Advair, Tylenol	NONE	Lupus Dxed in Past			1						1	Dizziness; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~MU1459AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229678	11/24/2004	UT	66.0	65		F		On 11/16/2004 received pneumococcal vaccine on right arm along with Flu vaccine on left arm. On 11/17/2004 AM pt's right arm became red, hot and swollen. Nurse taking phone call referred pt to her physician for evaluation.									U	11/16/2004	11/17/2004	1		PUB	PVT	Lipitor	NONE	Allergic to PNC, High Cholesterol			1						1	Feeling hot; Injection site erythema; Oedema	FLU3~SANOFI PASTEUR~U1530AB~7+~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0865N~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0229679	11/24/2004	ID	50.0	49		F	11/15/2004	achy the rest of the day. More severe pain started 10/30/2004. Pain extends from neck to elbow. it feels like when I had bursitis, continues to be very painful, taking antiinflammatory. Reaction site occurred from influenza vaccine left deltoid.				Y					U	10/29/2004	10/29/2004	0	NONE	PUB	PVT	Augmentin, Zoloft, Sinemet, Lisinopril	Poisonous spider bite 10/21/04	Zoloft for Depression, HTN			1						1	Injection site reaction; Myalgia	FLU3~SANOFI PASTEUR~U1489AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0945N~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0229680	11/24/2004	WI	65.0	65		F	11/17/2004	Welts like hives-3 1/2 days lasted- itched were under arms, thigh, waist, below breasts, arms. Treated with Benadryl and Cortaid. Both worked used both round the clock for 3 1/2 days. Both worked well.									Y	11/06/2004	11/06/2004	0		PVT	OTH	Am on Celebrex and a water pill, multiple vitamin B, C, E, Calcium, New Phase		NONE			1						1	Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0229681	11/24/2004	WV	1.26	1	.3	F	11/11/2004	Hives and Local swelling of left injection site									Y	11/08/2004	11/10/2004	2		PVT	PUB		NONE	PPS/Biscuspid pulmonic valve			1						1	Injection site oedema; Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~598A2~4~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1516AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0366P~5~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~A74404C~5~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0229682	11/24/2004	PA	5.0	4		M	11/17/2004	Child became pale, lost vision, light headed diaphoretic. Child was asked to be down vs checked, given some juice and recovered.				Y					Y	11/17/2004	11/17/2004	0		PVT	UNK		NONE	Wheezing illnesses			1						1	Blindness; Dizziness; Hyperhidrosis; Pallor	FLU3~SANOFI PASTEUR~U1488AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229683	11/24/2004	NY	71.0	70		F	11/17/2004	Left sided facial droop; incomplete blink. Dx. Bell's Palsy.				Y					U	11/09/2004	11/15/2004	6	Ct head ruled out acute CVA	OTH	PVT	Fejoy, Prozac, Senokot, MVI with minerals, Zinc, Vit C, Lantus, Glucovance	Acute	Allergies,PCN, Quinolones (Cipro); Dx: Diabetes Mellitus; Neurogenic bladder; Multiple sclerosis with paraplegia.			1						1	Facial palsy	FLU3~SANOFI PASTEUR~U1463AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229684	11/24/2004	CA	0.6	0	.6	F	11/10/2004	Rash, hives, developed 3hrs post initial influenza vaccine treated with Benadryl.									Y	11/09/2004	11/09/2004	0		MIL	MIL	Tylenol	Early URI primarily mild nasal congestion	NONE			1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~U1515AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229685	11/24/2004	CA	66.0	66		M	11/12/2004	Patient's arm became red, swollen and sore. States arm puffed up from shoulder to elbow. Went to doctor on 11/10. Rx was Vicodin, Benadryl and Ibuprofen. Swelling worsened on 11/11; went back to doctor with complaints of decreased appetite, low grade fever, arm hot. States getting better today. Swelling starting to subside.				Y					U	11/09/2004	11/09/2004	0		OTH	PVT	Metformin; Quinine; Lovestatin; Botensin		Allergic to penicillin; Diabetes; Asthma			1						1	Decreased appetite; Feeling hot; Injection site erythema; Injection site swelling; Oedema peripheral; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1556AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0287P~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0229686	11/24/2004	NV	67.0	66		F	11/15/2004	Diagnosed MS after vaccination approximately 3 days; bilateral foot drag and general exacerbation symptoms. Treated with Solumedrol and Prednisone.									Y	10/23/2004	10/26/2004	3		PUB	PVT	Norvasc; Tegretol; Accuretic; Betaserone	MS	MS			1						1	Condition aggravated; Multiple sclerosis	FLU3~SANOFI PASTEUR~U1453CA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229687	11/24/2004	MD	49.0	48		M	11/22/2004	Friday afternoon, felt mildly feverish. Friday evening, fever 101; Motrin took fever away. 6 PM Sunday, 11/21/04, fever 100.5; successfully treated with Motrin.									Y	11/18/2004	11/19/2004	1	NONE	UNK	UNK		NONE				1						1	Pyrexia	FLU3~SANOFI PASTEUR~U1418AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABA026BA~1~~LA~HEP A + HEP B (TWINRIX)~1|IPV~SANOFI PASTEUR~X1189~1~~RA~POLIO VIRUS, INACT. (IPOL)~1|JEV~SANOFI PASTEUR~EJN213A~1~~LA~JAPANESE ENCEPHALITIS (JE-VAX)~1|PPV~MERCK & CO. INC.~0974N~1~~RA~PNEUMO (PNEUMOVAX)~1|TYP~SANOFI PASTEUR~X0521~1~~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0229688	11/24/2004	CA	73.0			F		Perfectly healthy and feeling great when shot was administered. Within 1-1.5 hours started getting violent chills. Later body aches, temperature up to 101, sweats and eventually rash from chest down on back lower legs. I stopped taking Cipro and started on Benadryl. 6 days later, I was ok.									Y					UNK	UNK	Had taken Cipro for 10 days. Basal cell removed from ear.	NONE	Basal cell removed from ear.			1						1	Chills; Pain; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U1519AB~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229689	11/24/2004	WY	5.0	5		M	11/19/2004	Right arm red at shoulder; 4 circumference.									Y	11/17/2004	11/19/2004	2		PVT	OTH		NONE	NONE			1						1	Erythema	DTAP~UNKNOWN MANUFACTURER~~5~IM~RA~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0229706	11/24/2004	VA	77.0	77		F	11/19/2004	Received pneumococcal vaccine, lot # 0926N, on 11/10/04. Developed cellulitis, itching and rash later that day. Daughter applied warm compresses to site and gave Benadryl 50mg.									Y	11/15/2004	11/15/2004	0	NONE	PUB	PUB	UNK	NONE	NONE			1						1	Cellulitis; Pruritus; Rash	FLU3~SANOFI PASTEUR~U1528AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0926N~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0229658	11/26/2004	PA	33.0	33		F	11/26/2004	Posterior cervical reactive lymphadenopathy (on right side) 3 days following administration of FluMist.									U	11/24/2004	11/26/2004	2		UNK	UNK		none	none			1						1	Lymphadenopathy; Lymphadenopathy	FLUN3~MEDIMMUNE VACCINES, INC.~unknown~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0229659	11/26/2004	NY	85.0	85		M	11/26/2004	The day after flu vaccine patient had erythematous maculopapular rash on neck R.L blanches with compression.									Y	10/07/2004	10/08/2004	1		UNK	UNK	1)   ACETAMINOPHEN TAB  500MG PO QID PRN for pain or fever  ACTIVE 2)   ALUMINUM ACETATE POWDER,TOP  1 PACKET TOP QD to        ACTIVE        inguinal areas to absorb moisture 3)   BUPROPION TAB  75MG PO BID for bipolar disorder        ACTIV	None	Problem List:  Bipolar I Disorder, most Recent Episode Depressed, unspecified Generalized Anxiety Disorder * (ICD-9-CM 300.02) Chronic Obstructive Pulmonary Disease Coronary Artery Disease Iron deficiency anemia secondary to blood loss (chronic) Essential Hypertension Tinea Urinary tract infection, site not specified			1						1	Erythema; Rash maculo-papular	FLU3~SANOFI PASTEUR~U1427AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229660	11/26/2004	MI	73.0	72		M	11/26/2004	Pt. received a Td vaccine in her left deltoid on 11/11/2004 @1210.  She returned to see the doctor on 11/24/2004 with pain, redness, edema and induration to the left deltiod area.  Dr. prescribed a Medrol dose pack for the patient.				Y					Y	11/11/2004	11/19/2004	8	N/A	UNK	UNK	CARDIZEM CD 300mg DAILY FOSAMAX 70mg WEEKLY HCTZ 25mg DAILY	NONE	HTN, HYPERLIPIDEMIA, OSTEOPOROSIS & OBESITY			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1505AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U1347AA~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0229663	11/26/2004	MD	44.0	44		F	11/26/2004	Intranasal influence vaccine received approx. 9:30 AM Tues Nov 23. Extreme nausea, vomiting, stomach cramps, weakness, dizziness started approx. 4:00 AM Wed Nov. 24 and continued through approx noon Thurs Nov. 25. Was quickly dehydrated. Was able to start keeping down limited liquids on Thursday afternoon. Still week but could eat bland foods Friday evening Nov 26.									Y	11/23/2004	11/24/2004	1		UNK	UNK	Nasacort; steriod creme on surgical scars; neurontin 1200 mg/day	None	- allergy (high fever, rash): penicillin - sensitivity (nausea, vomiting): NSAIDs, erythromycin - had had surgery on L arm Oct 18, 2004			1						1	Abdominal pain; Asthenia; Dehydration; Dizziness; Nausea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229232	11/29/2004	VT	41.0	41		F		This is a non serious spontaneous case from a nurse who reports a pt experienced chest pain. The reporter causality was not provided. This case is being submitted as part of the accelerated reporting program. A 41 year old female experienced chest pain, chest discomfort, and uncomfortable feeling after receiving FluMist. At approx 4 PM on 04Nov04, the pt received FluMist and subsequently experienced mild symptoms which included uncomfortable feeling, fleeting chest pain, and chest discomfort. The pt has recovered.  The pt has a history of chest discomfort but not history of cardiac, gastrointestinal, or pulmonary problems.									Y	11/04/2004	11/04/2004	0		PUB	OTH	NONE		History unremarkable for cardiac/pulmonary/gastrointestinal problems, non smoker, history of chest discomfort.		MEDI0002408	1						2	Chest discomfort; Feeling abnormal; Pain; Chest discomfort; Chest pain	FLUN3~MEDIMMUNE VACCINES, INC.~500333P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~IN50333P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0229234	11/29/2004	VT	42.0	41		F	11/10/2004	This is a non serious spontaneous case from a nurse reporting a pt who experienced Chest discomfort. The reporter causality was not provided. This case is being submitted as part of the accelerated reporting program. A 41 year old female experienced chest discomfort, chest pain, and palpitations after receiving FluMist. At approx 4PM on 04Nov04, the pt received FluMist and approx 6PM developed chest discomfort, chest pain, and fleeting palpitations for two hours. The events subsided and the pt has recovered. The causality between events and FluMist vaccination.									Y	11/04/2004	11/04/2004	0		PUB	OTH			History unremarkable for cardiac/pulmonary/gastrointestinal problems, nonsmoker.		MEDI0002405	1						2	Chest pain; Palpitations; Chest discomfort; Chest pain; Palpitations	FLUN3~MEDIMMUNE VACCINES, INC.~500333P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~IN50033P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0229235	11/29/2004	VT	40.0	40		M		This is a non serious spontaneous case from a nurse reporting a pt who developed palpitations after receiving FluMist. The reporter causality was not provided. This case is being submitted as part of the accelerated reporting program. A 40 year old male experienced chest discomfort, anxiety, and palpitations, after receiving FluMist. On 04Nov04, the pt received FluMist at approximately 4PM and subsequently experienced 30 minutes of palpitations, anxiety and chest pain. The pt has recovered. He has not history of cardiac, pulmonary, or gastrointestinal problems. The reporter did not provide causality between events and FluMist vaccination. This pt was one of four health care professionals that experienced adverse events after FluMist vaccination at same medical center.									Y	11/04/2004	11/04/2004	0		PUB	OTH			History unremarkable for cardiac/pulmonary/gastrointestinal problems, non smoker		MEDI0002409	1						2	Anxiety; Palpitations; Anxiety; Chest discomfort; Chest pain; Palpitations	FLUN3~MEDIMMUNE VACCINES, INC.~500333P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~IN50333P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0229236	11/29/2004	VT	31.0	31		F	11/10/2004	This is a non serious spontaneous case from a nurse reporting a pt who experienced Chest discomfort. the reporter causality was not provided. This case is being submitted as part of the accelerated reporting program. A 31 year old female felt weird. The pt experienced chest pain and chest discomfort on the same day. On 05Nov04, the pt experienced a runny nose and sore throat. The pt has recovered from all events. The pt is healthy and has no history of cardiac, pulmonary, or gastrointestinal problems.									Y	11/04/2004	11/04/2004	0		PUB	OTH			History unremarkable for cardiac/pulmonary/gastrointestinal problems, non smoker		MEDI0002407	1						2	Chest pain; Feeling abnormal; Chest discomfort; Chest pain; Feeling abnormal; Pharyngolaryngeal pain; Rhinitis	FLUN3~MEDIMMUNE VACCINES, INC.~500333P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~IN50333P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0229727	11/29/2004	MA	76.0	76		F	11/29/2004	Swelling, pain, hot, very red, ending with itchiness. Reaction/itchiness occurred from Pneumovax (LL).									Y	11/15/2004	11/15/2004	0	none	UNK	UNK	Tylenol, Sotalol, ic-furosemide, Paxil, Triazolame	None	Atrial fibrillation Angina			1						1	Erythema; Feeling hot; Injection site reaction; Pain; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U1519AB~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~3~IM~LL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0229747	11/29/2004	VA	74.0	73		M	11/15/2004	To ER approximately 30 minutes after receiving injection. Complained of generalized chills, fever 100.3 up to 103, BP 145/71 at 1:15 PM and BP 73/43. Dopamine drip started. Admitted CCU 11/12/04. Off Dopamine drip. Discharge Summary received on 2/2/2005 states pneumonia. Medical Records received on 2/2/2005 states sepsis and fever.					Y	3			Y	11/11/2004	11/11/2004	0	WBC 16.4. Discharge Summary received on 2/2/2005 states leukocytosis and X-ray abnormal.	PUB	PUB	Atenolol; Nitrostat; HCTZ	NONE	Heart surgery; MI; COPD; CHF; Allergy to Levoquin. Discharge Summary on 2/2/2005 states cholesteremia and renal insufficiency. Medical Records received on 2/2/2005 states tobacco abuse.		VA04041	1						1	Blood pressure decreased; Chills; Laboratory test abnormal; Leukocytosis; Pneumonia; Pyrexia; Sepsis	FLU3~SANOFI PASTEUR~U1528AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0229748	11/29/2004	VA	82.0	82		M	11/15/2004	Passed out at a restaurant. Taken to ER by ambulance. Diaphoretic. BP 97/67; admitted to CCU. Information from Discharge summary states allergic reaction. msv					Y	3			Y	11/10/2004	11/11/2004	1	WBC 72; BMP glucose 156, Na 134; Cardiac enzymes WNL. Information from Discharge summary states elevated blood sugar, abnormal urinalysis. msv	OTH	PVT	HCTZ; Lipitor; Prilosec; Reglan	NONE	Colon polyp; TURP; GERD; High cholesterol.  Information from Discharge summary states Hx of cerebral atrophy. msv		VA04043	1						1	Blood pressure decreased; Hyperglycaemia; Hyperhidrosis; Hypersensitivity; Loss of consciousness; Urine analysis abnormal	FLU3~SANOFI PASTEUR~U1497AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0229752	11/29/2004	CA	10.0	10		M	11/23/2004	c/o vomiting and diarrhea and HA.									U	11/23/2004	11/23/2004	0	NONE	PUB	PUB	NONE	ASX	Latex allergy, intestines not connected at birth.			1						1	Diarrhoea; Headache; Vomiting	FLU3~SANOFI PASTEUR~U1417AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229753	11/29/2004	OR	35.0	34		F	11/11/2004	6-12 hours post injection L arm pain at site up through neck, tender to touch.  Double vision in left eye. 6th cranial nerve palsy.				Y					N	11/08/2004	11/08/2004	0		PVT	PVT	NONE	NONE	Asthma			1						1	Injection site pain; Paralysis; Tenderness; Visual disturbance	FLU3~SANOFI PASTEUR~U1443AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229754	11/29/2004	TX	65.0			F	11/29/2004	Positive reaction: Red blotchy patches on face later developing on torso 5 days post vaccine. Client on Meds during administration of vaccine. Treatment with steroid injection.				Y					Y	11/13/2004	11/18/2004	5		UNK	UNK	Cleomycin	Vaginal infection				1						1	Erythema; Rash macular	FLU3~SANOFI PASTEUR~U1462AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229756	11/29/2004	NC	33.0	32		F	11/29/2004	11/24: sore throat next day, then decreased appetite 48 hours later had temp of 103.3F. 11/29: still having weakness, tired: no energy				Y					U	11/23/2004	11/24/2004	1		PUB	PUB		NONE	NONE			1						1	Asthenia; Decreased appetite; Fatigue; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500339P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0229757	11/29/2004	CA	40.0	40		F	11/16/2004	Itching and swelling at injection site lasting 12 hours.									Y	11/01/2003	11/01/2004	366		PVT	PVT	NONE	NONE	NONE			1						1	Injection site reaction; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U1394EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229758	11/29/2004	VA	66.0	65		F	11/22/2004	Within two hours of receiving flu shot, broke out in rash over arms and trunk and had severe itching. No respiratory symptoms.				Y					Y	11/22/2004	11/22/2004	0		PVT	PUB		none	PCN Allergy: has COPD			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U1503AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229759	11/29/2004		1.94	1	.9	M	11/12/2004	Patient received shot in left thigh. Thigh was very swollen, warm to touch, itchy. Skin was very tight.									U	11/10/2004	11/11/2004	1		MIL	MIL		Congestion				1						1	Feeling hot; Pruritus; Skin reaction; Swelling	FLU3~SANOFI PASTEUR~U1131AA~3~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229760	11/29/2004	NY	4.0	4		M	11/22/2004	Child received flu vaccine on 11/9/04 in AM and was sent home from preschool in afternoon because child had swollen face and low grade temp. Child had swollen face through 11/18/04 accompanied by loss of appetite and diarrhea. No medical treatment sought.									Y	11/09/2004	11/09/2004	0		PUB	PUB	NONE	NONE	NONE			1						1	Anorexia; Diarrhoea; Pyrexia; Swelling face	FLU3~SANOFI PASTEUR~U1516AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229761	11/29/2004	CO	1.0	1	.0	U		Small knot under injection site around 1cm. Numerous red spots some with central papules and one with a scab.									U	11/12/2004	11/13/2004	1		PVT	PVT	NONE	NONE	NONE			1						1	Injection site mass; Rash; Rash papular	FLU3~SANOFI PASTEUR~U1476AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A57560H~4~~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0198P~1~~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0229762	11/29/2004	WI	61.0	61		F	11/17/2004	Pt reported fluish in PM, arm sore then temp 104 degrees, body aches, headache. No appetite. Temp 102 on 10/20 upon arising. 101 PM. By 10/21 temp 101-99. Still achy. Poor appetite.									Y	10/19/2004	10/20/2004	1		PVT	PVT	Aciphex	NONE	NONE			1						1	Anorexia; Headache; Influenza like illness; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1450AA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229763	11/29/2004	SC	6.0	5		M	11/22/2004	Myositis : three weeks after vaccine given 11-19-04.  Medical Records received on 12/07/2004 states heart murmur and leg pain. Medical Records received on 2/02/2005 states 2/02/2005 states congestion, runny nose, fever, and heart murmur.				Y					Y	10/25/2004	11/19/2004	25	CK=874, Rapid flu neg. Medical Records received on 12/07/2004 states lab results abnormal.	PVT	PUB		none	asthma;Medical Records received on 12/07/2004 states URI.			1						1	Cardiac disorder; Cardiovascular disorder; Laboratory test abnormal; Myositis; Nasal congestion; Pain; Pyrexia; Rhinitis	FLU3~SANOFI PASTEUR~41439AA605~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229764	11/29/2004	MA	54.0	54		F	11/22/2004	Complained of redness and swelling at vaccination site. Complained of heat at area. 11/20/04 went to Treatment Center . S/B MD . Treated with Keflex and Benadryl.				Y					Y	11/18/2004	11/20/2004	2		PUB	PUB		Lupus			MA0401	1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1519AB~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229765	11/29/2004	OH	1.14	1	.1	F	11/22/2004	Patient with prior bronchiolitis / RAD: seen after resolution of pulmonary symptoms, received flu vaccine, began wheezing that night, confirmed to wheeze, seen in ER 11/8				Y					Y	11/04/2004	11/04/2004	0		PVT	UNK		NONE	?RAD			1						1	Wheezing	FLU3~SANOFI PASTEUR~U1498AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229766	11/29/2004	WA	50.0	49		F	10/28/2004	Ache/stiffness from neck down to elbow x 2 days. Nausea, head cold lasted 5 days, temperature, chills, severe flu-like symptoms secondary eye infection required antibiotics.				Y					Y	10/20/2004	10/21/2004	1	Very sick again on 11/6-10 = flu	MIL	PUB	Vitamins/Minerals				WA042079	1						1	Chills; Eye inflammation; Infection; Influenza like illness; Joint stiffness; Musculoskeletal stiffness; Nasal congestion; Nausea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1489AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229767	11/29/2004	VA	70.0	70		M	11/12/2004	to ER leg complained of generalized aches, headache, weakness, trembling, confusion.  began approximately 1pm. Shaking BP 160/96 = 145/74 T 98.  Medical Records received on 12/07/2004 diaphoresis and hypertensive.				Y					Y	11/11/2004	11/11/2004	0	BMP and CBC WNL. bun 30 Creatinine 1.9 WBC 5.0	PUB	PUB	Atenolol, Fosamax, Cogoas, Zoloft, Valium, Lontab	NONE	Asthma, allergies: PCN, Codeine. Medical Records received on 12/07/2004 states cardiomegaly and tobacco use.		VA04042	1						1	Asthenia; Confusional state; Headache; Hyperhidrosis; Hypertension; Pain; Tremor	FLU3~SANOFI PASTEUR~U1528AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229768	11/29/2004	WA	1.65	1	.6	F	11/04/2004	Vomiting, Fussiness. Diagnosis was Gastritis (obtained from phone call to responsible physician)				Y					Y	11/01/2004	11/01/2004	0		PVT	UNK	NONE	NONE	NONE		WA042074	1						1	Gastritis; Irritability; Vomiting	FLU3~SANOFI PASTEUR~U1404AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229769	11/29/2004	WA	0.78	0	.8	M	11/16/2004	Mother states his eyes rolled back in his head and he had a grand mal seizure that lasted several months with a postictal phase. Taken to ER per 911.				Y					Y	11/08/2004	11/09/2004	1		PUB	PUB	NONE	NONE	NONE		WA042077	1						1	Convulsion; Eye movement disorder; Postictal state	DTAP~SANOFI PASTEUR~C1699AA~3~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1512AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0373N~3~IM~RL~HEP B (RECOMBIVAX HB)~1|HIBV~SANOFI PASTEUR~UE206AA~3~IM~RL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~X0799~3~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~A74398C~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0229776	11/29/2004	MI				F	11/08/2004	This is a non serious spontaneous case from a consumer requiring an ER visit due to periorbital cellulitis. The reporter causality to FluMist is not provided.  A consumer reported a case of periorbital cellulitis in a female neighbor. Pt's demographics and past medical history were not reported. The pt received FluMist on or about 05Nov04. On 05Nov04, the reporter stated the pt had swelling and pain around one eye. The events continued over the weekend. On 07Nov04, the pt presented in the ER and had a CT scan. The pt did not have an infection behind her eye and the documented contition was periorbital cellulitis. She was sent home with a three day antibiotic regimen. As of 08Nov04 the reporter stated the pt was feeling much better. Follow up 03/07/05: Several attempts had been made to obtain vaccine lot number and patient's date of birht and age. As of 03/07/05 no information was received. A letter requesting addtional information will be sent to the reporter.				Y					N	11/05/2004	11/05/2004	0	CT scan 11/07/04 no infection	OTH	OTH					MEDI0002395	1						1	Cellulitis; Eye oedema; Eye pain	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0229810	11/29/2004	AZ	83.0	82		F		Vaccine given at 9:30am : around 5pm. I became dizzy and repeatedly felt that I was passing out/ tingling of hands feet and face. Next day started dizziness: all these mentioned continued for four days. Very tired. Slept a lot : pulse 103 to 113.									Y	11/13/2004	11/13/2004	0		PUB	UNK						1						1	Dizziness; Paraesthesia	FLU3~SANOFI PASTEUR~U1575AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0228241	11/30/2004	NY	1.59	1	.6	F	11/01/2004	Patient received three vaccines on 10/01/2004 - Prevnar, DTaP and the flu shot. Fever of 103 with Tylenol, seizure type behavior, repetitive rambling of words, arm flapping. Started on same day and certain behavior has continued since. Please note patient received flu shot last year although no thimerosal was in last year's shot. This year there was thimerosal.				Y					N	10/01/2004	10/01/2004	0	MRI with sedation and EEG. Test results negative. Neurologist feels allergic reaction caused encephalopathy.	PVT	UNK	None	Fighting off a cold - Dr. was advised	None			1						2	Abnormal behaviour; Convulsion; Movement disorder; Pyrexia; Speech disorder	DTAP~GLAXOSMITHKLINE BIOLOGICALS~514B9~4~IM~UN~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1383AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A74399C~4~IM~UN~PNEUMO (PREVNAR)~1|DTAP~SMITHKLINE BEECHAM~A614B9~4~UN~UN~DTAP (INFANRIX)~2|FLU3~SANOFI PASTEUR~U1383AA~3~SYR~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|PNC~PFIZER\WYETH~A74399C~4~UN~UN~PNEUMO (PREVNAR)~2	USA	Emergency room visit	Influenza
0229340	11/30/2004		34.0	33		F	11/23/2004	Patient awoke at 0300 with facial burning and irritation and eyes were swollen shut. No shortness of breath. Had moderate edema of forehead and periorbital area. Treated with Benadryl.				Y					Y	10/26/2004	10/27/2004	1		MIL	MIL	Motrin, Ambien					1						2	Face oedema; Eye swelling; Face oedema; Skin burning sensation; Skin irritation	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1457AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0229356	11/30/2004	NJ	57.0	57		F	11/30/2004	Patient called to report discomfort in her left arm.  She had her flu vaccine on 10-28-04 at which time she felt an immediate tingling at the site, going down her arm to her fingers.  She states it has been chronically getting worse.  According to her, there is no redness or swelling, nor has there ever been.  It has been getting more painfull with time and because of the pain has a limited ability to move her arm and fingers. She complains of being kept up at night due to the pain.  She visited her PMD on 11/15/04; prescribed Bextra 10mg OD.  No relief noted on 11/17/04 when she called to report it to us (the vaccine provider).				Y					U	10/28/2004	10/28/2004	0		UNK	UNK						1						2	Injection site pain; Joint range of motion decreased; Pain; Paraesthesia; Discomfort; Hypokinesia; Paraesthesia	FLU3~SANOFI PASTEUR~U1455EA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1455EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0229815	11/30/2004	OH	0.68	0	.7	F	11/18/2004	Phone call from Mom today reporting child received Fluzone vaccine on 11/8/04 had diarrhea stool on way home from clinic and has had 2 to  every day since.  Called PCP and was told it was probably a virus but mom was concerned because sister-in-law did not let her children receive flu vaccine because she was afraid of the mercury.  Consoled mom by reading adverse reactions reported in literature - none of which included GI disturbance.  Child has had all other childhood immunizations without incident.									U	11/08/2004	11/08/2004	0	None	UNK	UNK	Prevacid		Acid reflux - severe			1						1	Diarrhoea; Viral infection	FLU3~SANOFI PASTEUR~U1427AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229817	11/30/2004	WI	0.6	0	.6	M	11/30/2004	One hour after immunization patients cheeks became reddened, lips swelled slightly. Over the next 2-3 hours he developed a blotchy rash to trunk and arms. Temperature max 99.1. Irritable over night, crying inconsolable. Decreased oral intake.									Y	11/29/2004	11/29/2004	0	none	UNK	UNK		none				1						1	Agitation; Decreased appetite; Face oedema; Flushing; Irritability; Pyrexia; Rash; Rash macular	FLU3~PFIZER\WYETH~U1516AA~1~~RL~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0229821	11/30/2004	KY	41.0	40		F	11/15/2004	Approximately 45 minutes after receiving Influenza vaccine, patient began experiencing dizziness, a generalized itchy feeling and welts on her stomach, chest, and neck.  Approximately 45 minutes after onset of previous symptoms, sh began to feel as if she would pass out (consciousness never lost) and inabliity to catch her breath.  She was transported by ambulance to the hospital. Benadryl and nasal Oxygen  given with little symptom relief.  Epinephrine was then given, Both drugs caused a rapid heart rate.  Symptoms of dizziness, itching and welts eased.  Oxygen saturation levels improved.  Because of her history of cardimyopathy, she was admitted for further testing and observation. Discharge Summary received on 1/12/2005 states chest pain.				Y	Y	1			Y	11/04/2004	11/04/2004	0		UNK	UNK	Norvas, Lasix, K-Dur, ASA, Nitro Patch, Protonix, Ativan, Flovent, Proventil	none; Medical records received on 1/12/2005 states sinusitis.	Cardiomyopthy, Asthma, allergies to Sulfa, Ultram, Darvocet, Imtrex. Discharge Summary received on 1/12/2005 states CHF, angina, hypertension, tobacco use, sinusitis, GERD, and anxiety. Medical Records received on 1/12/2005 states edema.		KY2004046	1						1	Dizziness; Dyspnoea; Hypoxia; Pruritus; Tachycardia; Urticaria	FLU3~SANOFI PASTEUR~U1503AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0229822	11/30/2004	MN	42.0	42		F	11/30/2004	Received Influenza vaccine 2:20PM November 23rd, 2004 - at @ 2:45 PM that day - vaccination site began to itch - noted erythema and swelling insued. By 3PM swelling and redness to elbow joint. Scratchiness of throat and shortness of breath followed. Notable wheezing and uticaria of mouth and nose.  Oxygen saturation 92% on room air - 50mg oral benadry given, BP 68/42; IV started 3:10PM - 80mg solumedrol via IV.  oxygen give at 2L;  Albuterol 2.5mg via neb. Monitored for two hours - injection site continued to be red and swollen - breathing and itching improved post medication administration - sent home with Prednisone 20mg daily for 5 days; Benadryl 25mg daily for three days; albuterol inhaler 2 puffs as needed for shortness of breath. Medical Record received on 1/03/2005 states hypotension.				Y					Y	11/23/2004	11/23/2004	0		UNK	UNK	Prozac Multivitamin	none				1						1	Dyspnoea; Erythema; Hypotension; Hypoxia; Injection site hypersensitivity; Pharyngolaryngeal pain; Pruritus; Swelling; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~1460~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229824	11/30/2004	AZ	5.0	5		F	11/30/2004	20 minutes after receiving the immunizations, the child c/o of being thirsty and the mother gave her orange juice.  The child immediately vomited and starting having severe difficulty in breathing. Medical Records received on 2/2/2005 states pt experienced wheezing and allergic reation.			Y	Y					U	11/30/2004	11/30/2004	0		UNK	UNK	Pulmicort Albuterol		Asthma			1						1	Condition aggravated; Dyspnoea; Hypersensitivity; Thirst; Vomiting; Wheezing	DTAP~SANOFI PASTEUR~U1300DA~5~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1454AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X0772~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0313P~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Life Threatening	Influenza
0229828	11/30/2004	NM	43.0	43		F	11/30/2004	Reports generalized achiness approximately 1-2 days post vaccination, progressed to burning sensation and pain bilateral lower extremities, legs started to feel heavy, difficulty walking, unsteady, involuntary muscle spasms. No sensory loss, no incontinence.  Denies recent illness, Reports previous flu vaccination 2 weeks prior, with concerns about 1/2 dosing as instructed by nurse administering injection, documentation of this dose is not available at this time. Diagnosis: Transverse Myelitis Rx with Solu-Medrol, Prednisone, neurontin, ibuprofen Patient remains in SAC unit. Medical Records received on 2/02/2005 states pt experienced abnormal reflex.				Y	Y	6			U	11/13/2004	11/14/2004	1	Medical Record received on 2/02/2005 states CSF abnormal.	UNK	UNK	None	NONE	Family history of Systemic mastocytosis, has been tested multiple time and has been clear. Other family members have been instructed to avoid vaccination. Allergy to Codiene. Hx of hammer toe repair. Medical Record received on 2/02/2005 states allergy, rheumatic fever/murmur, and glucose intolerance.			1						1	Balance disorder; CSF test abnormal; Difficulty in walking; Dyskinesia; Hyporeflexia; Myelitis transverse; Pain; Sensation of heaviness	FLU3~SANOFI PASTEUR~U1456AAA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0229846	11/30/2004	WI	58.0	57		F	11/18/2004	Right shoulder and neck became red, swollen, and painful; had a black out spell and dizzy spells. Discharge Summary received on 12/22/2004 states pt experienced fever and immunization reaction.					Y	1			Y	11/16/2004	11/17/2004	1		PVT	OTH						1						1	Dizziness; Erythema; Loss of consciousness; Pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U1380AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~05790~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0229847	11/30/2004		21.0	21		F	11/30/2004	Blood shot eyes, swollen throat, change in voice, elevated pulse, all within 10 min of coughing episode. 50 mg Benadryl po, 60 mg Prednisone po, Transport to ER.				Y					Y	11/18/2004	11/18/2004	0		MIL	MIL	DEPO, Bactrim DS					1						1	Cough; Dysphonia; Heart rate increased; Ocular hyperaemia; Pharyngeal oedema	FLU3~SANOFI PASTEUR~U1459AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229848	11/30/2004	WY	24.0	23		F	11/30/2004	1 hour after injection, experienced hot flashes, itchiness, burning feelings , sweating. 2 hours after injection expeirenced throat swelling and a light headedness, along with other symptoms from previous. Second day same symptoms with kidney pain. Not seen by dr on 10/21/04. Medical records from 08/17/05 include allergic reaction and nephritis.				Y					Y	10/21/2004	10/21/2004	0	Medical records document leukocytosis.	PVT	PVT			Post concussive syndrome, chronic headaches.  Medical records state hx of kidney calculus and allergy.			1						1	Dizziness; Hot flush; Hyperhidrosis; Hypersensitivity; Laryngospasm; Leukocytosis; Nephritis; Pruritus; Renal pain; Sensory disturbance	FLU3~SANOFI PASTEUR~U1496AA~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229849	11/30/2004	MI	1.89	1	.9	F	11/30/2004	Increased temps 101-103 within 24 hours.									U	11/29/2004	11/29/2004	0	- negative strep screen	PVT	UNK						1						1	Pyrexia	FLU3~SANOFI PASTEUR~U1437AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229850	11/30/2004	WI	69.0	69		F	11/01/2004	Describes reaction of welt (redness and warmth) at previous vaccination site (~2000). then received half dosage. This year, no vaccine. Vaccine administered 10/28/04 at left arm: denies any mark / irritation on left arm. Complained of itching and redness chest and neck about 4 hours later and blotchy red areas (itchy) on both legs 10/19: legs red. today 11/01/04 notified health department.									Y	10/28/2001	10/28/2004	1096		PUB	PVT			Previous welt with previous flu vaccine site.		WI0417	1						1	Erythema; Pruritus; Rash macular; Similar reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~41504AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229851	11/30/2004	CA	50.0	50		M	11/23/2004	pt describes mild aches, chills and cannot sleep at night. Temp 38.0C. Pt received flu vaccine 11/22/04 in afternoon. Symptoms began late that night. Sent home form work 11/23/04 to rest.									U	11/22/2004	11/22/2004	0		PUB	UNK						1						1	Chills; Insomnia; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1411AA~1~ID~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229852	11/30/2004	TX	1.01	1	.0	F	11/24/2004	Varicella vaccine administered on 11/10/2004. Patient developed varicella like pox on 11/22/04. <50, 2-4 mm pink papules, developing thin vesicles at site of vaccine on leg and arm, trunk face.									Y	11/10/2004	11/22/2004	12		PVT	PUB	PPD Shot					1						1	Injection site rash; Rash papular; Rash vesicular	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~21931A2~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1407AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0096P~3~IM~RL~HIB (PEDVAXHIB)~1	USA		Influenza
0229853	11/30/2004	VA	21.0	21		M	11/01/2004	21 y/o male report with rash across chest/ stomach/ neck. Received small pox vaccine 19OCT2004. Disseminated vaccinia.				Y					Y	10/19/2004	10/28/2004	9		MIL	MIL	Tylenol, Benadryl					1						1	Cow pox; Rash	ANTH~EMERGENT BIOSOLUTIONS~FAV082~1~IM~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1501AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~Y020072~1~ID~LA~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0229854	11/30/2004		26.0	26		M	11/03/2004	17 days post smallpox primary inoculation, post 7 day post take check with event to medical complaining of large weeping smallpox site and erupting rash consistent with band-aid pattern.				Y					Y	10/16/2004	11/10/2004	25		MIL	MIL	SUPPS; Creatine					1						1	Injection site abscess; Injection site rash	ANTH~EMERGENT BIOSOLUTIONS~FAV083~1~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1457AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~Y020072~1~ID~LA~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0229856	11/30/2004	MA	48.0			M	11/26/2004	Felt cold like symptoms voice hoarseness , chest ache. Taken shot on 11/17/2004 9.30am. After series of acupuncture sessions, side effects all gone.									Y					UNK	UNK						1						1	Chest pain; Dysphonia; Influenza like illness	FLU3~SANOFI PASTEUR~U1455DA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229857	11/30/2004	CA	84.0	83		M	11/26/2004	About 15 minutes after the flu shot, complaint of discomfort her face and ear are tender. Having problems breathing. Epi-pen 0.3 mg IM were given in left arm. Ambulance was on the way. She later transported to ER. Blood pressure was low. After being stabilized in hospital, she was discharged with treatment of Prednisone 20mg onece daily for 2 days. Information from er summary states tachycardia, hypertension. msv				Y					Y	11/17/2004	11/17/2004	0		UNK	UNK			Information from ER summary states allergy. msv			1						1	Discomfort; Dyspnoea; Hypertension; Hypotension; Tachycardia; Tenderness	FLU3~SANOFI PASTEUR~U1479AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229498	12/01/2004	KY	4.0	4		M	11/19/2004	Left arm severly swollen elbow up to shoulder, redness.				Y					Y	11/05/2004	11/06/2004	1		UNK	UNK		none			KY2004048	1						2	Erythema; Oedema peripheral; Erythema; Oedema peripheral	DTAP~SANOFI PASTEUR~C2044AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1380AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1040~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1039N~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|DTAP~SANOFI PASTEUR~C2044AA~5~IM~LA~DTAP (DAPTACEL)~2|FLU3~SANOFI PASTEUR~U1380AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|IPV~SANOFI PASTEUR~X1040~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~2|MMR~MERCK & CO. INC.~1039N~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~2	USA	Emergency room visit	Influenza
0229885	12/01/2004	OH	65.0	64		F	11/10/2004	Client claims pneumonia shot given in top of right shoulder on 10/26/04 at flu clinic.  Describes nurse as very young.  Student nurse giving pneumonia shots at that clinic.  Client presented at ER that evening with right arm pain and inability to raise right arm.  On 10/29/04 saw PCP who gave her Darvocet for pain.  Called HD 11/10/04 to report incident at husband's urging.  Has improved mobility of right arm from elbow to hand but remains restricted from shoulder to elbow, less pain now.  Says   who arm was originally numb.  Says reported no previous pneumonia shot when received but now feels she may have had one in past 5 years.				Y					Y	10/26/2004	10/26/2004	0		UNK	UNK	Unknown	No	Unknown			1						1	Hypoaesthesia; Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U1459AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0512P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0229889	12/01/2004	NJ	35.0	34		F	12/01/2004	Aproximately 40 minutes after receiving the vaccine, patient felt itchy all over. Her throat was hoarse and she eventually had difficulty speaking. Diphenhydramine 25mg IM and had no effect. Patient was taken to the ER where she received Solu-medrol. Patient recovered.				Y					Y	11/16/2004	11/16/2004	0		UNK	UNK	Unknown	None reported	Penicillin, Morphine			1						1	Dysphonia; Pruritus; Speech disorder	FLU3~SANOFI PASTEUR~41498AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229894	12/01/2004	CA	53.0	52		F	12/01/2004	One day after vaccine given, pt developed bullae on left UE and pre bullae on rt.				Y					U	11/30/2004	11/30/2004	0		UNK	UNK	Atenolol, Atorvostatin, ASA, Levothyroxine		none			1						1	Dermatitis bullous	FLU3~SANOFI PASTEUR~U15799AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0706P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0229896	12/01/2004	KY	45.0	45		F	11/18/2004	Left arm became reddened, swollen at site and warm. noticed lump under left clavicle. Later diagnosed by PMD as a swollen lymph node. Area under clavicle remains very sore.									Y	11/16/2004	11/18/2004	2		PVT	PVT	Lotril; Glucotrol; Glucophage; Anti-lipidemic	NONE	Diabetes			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Lymphadenopathy; Skin nodule	FLU3~SANOFI PASTEUR~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229897	12/01/2004	CA	22.0	22		F	12/01/2004	Fever 100-102 per patient history. Urticarial, blotchy, exanthem, tender outer and upper right arm.				Y					Y	10/27/2004	10/28/2004	1	NONE	PVT	PUB		Chronic cough; Asthma	NONE			1						1	Pyrexia; Rash; Rash macular; Tenderness; Urticaria	FLU3~SANOFI PASTEUR~U1451AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229898	12/01/2004	CA	1.04	1	.0	F	12/01/2004	Red, raised rash looking like bug bites on body and hands. Also fussiness and low grade fever.									U	11/17/2004	11/29/2004	12	NONE	PVT	PVT		NONE	NONE			1						1	Irritability; Pyrexia; Rash erythematous	FLU3~SANOFI PASTEUR~U1497AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0090P~3~~RL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0042P~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A671808~4~~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0229899	12/01/2004	CA	90.0	89		F	12/01/2001	Headache for 25 minutes. Given Tylenol 500mg and felt better. Vital signs stable before, during and after headache. No rash, no difficulty breathing.									Y	11/29/2004	11/29/2004	0	Heart rate unchanged (62-66); O2 Saturation 99%; Blood pressure unchanged 116/62.	PUB	UNK	Lotensin; Metropolol; Lipitor; ASA: HCTZ; Tylenol	HTN; Hyperlipidemia	NONE; Patient reports allergy to erythromycin			1						1	Headache	FLU3~SANOFI PASTEUR~U1556AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229900	12/01/2004	AZ	4.0	4		M	11/30/2004	Left arm cellulitic reaction to DTaP and IPV vaccination. Placed on Zithromax as allergy to Cephalexin.									Y	11/29/2004			NONE	PVT	PVT						1						1	Cellulitis	DTAP~GLAXOSMITHKLINE BIOLOGICALS~612A9~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1484AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~~4~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0852P~2~IM~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0229901	12/01/2004	MT	86.0	86		F	11/23/2004	Had injection at 4:00 PM. Began feeling dizzy about 8. Began feeling itchy and very lightheaded. Daughter called ambulance. BP on ER admission 62/44, O2 saturation upper 80s. CBC and EKG done and kept overnight. Was given albuterol treatment and IV. Daughter reported her mother had diarrhea for several days before flu shot. Follow up: Cardiomegaly is present. No acute infiltrates are identified.				Y	Y	1			Y	11/19/2004	11/19/2004	0	Tests were all negative.	PUB	PUB	Coreg	Had diarrhea several days previous.	Diarrhea			1						1	Blood pressure decreased; Cardiomegaly; Dizziness; Hypoxia; Pruritus	FLU3~SANOFI PASTEUR~U1556AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0229911	12/02/2004	MA	34.0	33		M	12/02/2004	Following the application of  Live, Intranasal Influenza Vaccine, I experienced basically all symptoms associated with a flu: sore throat, running nose, elevated temperature, elevated temperatures, weakness, loss of appetite. This lasted for 4 days now and is developing into a bronchitis now. The symptoms were so severe that I  was not able to continue work as an MD in the Neurology Department.									U	11/29/2004	11/29/2004	0		UNK	UNK	none	none	none			1						1	Anorexia; Asthenia; Bronchitis; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229912	12/02/2004	OK	2.0	2	.0	F	12/02/2004	3 cm area of erythema & induration appeared on right thigh within a few minutes of immunization, resolved within 30 minutes.									Y	12/01/2004	12/01/2004	0	none	UNK	UNK	Pulmicort, Zyrtec, Albuterol	cough	asthma			1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U1414AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~802A9~1~IM~LL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~A83578B~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0229915	12/02/2004	CT	16.0	15		F	12/02/2004	3 weeks after receiving the flumist, started coughing and the throat hurt. Four days go by still continuing on coughing and throat hurts even more. Went to Physician was tested for strep, negative. Doctor then thought it could be from starting the heat in the house, (pellet stove)that the air was to dry so we set up humidifier. A week goes by coughing gets more continuious, night and day, head hurts, chest hurts. Go back to doctor andhe puts her on amoxicyllian and phenylhistine cough medicine. We finish the amoxicillian and the coughing is still going on but has become worse. Every time she coughs she can't seem to get enough air back into her lungs so she can breath. Went back to the doctors office and saw doctor. She put her on Biaxin and Advair. It's been four days and no sign of relief yet.									N	10/15/2004	11/01/2004	17	strep culture/negative	UNK	UNK	allegra-d	healthy	allergic to pollen, pet dander			1						1	Chest pain; Cough; Dyspnoea; Headache; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~500335P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229917	12/02/2004	IN	52.0	52		F	12/02/2004	HIGH FEVER, CHILLS, SWEATING, SEVERE HEADACHE, NAUSEA & VOMITING, FATIGUE AND GENERAL MALAISE									U	12/01/2004	12/01/2004	0	none	UNK	UNK						1						1	Chills; Fatigue; Headache; Hyperhidrosis; Malaise; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1450AA~4~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229927	12/02/2004	MD	26.0			F	10/28/2004	This is a non serious spontaneous case from a nurse of a medication error. The reporter causality was not provided to Flumist. A nurse reported a series of medication errors. The nurse misunderstood the dosing instructions for FluMist and administered a double dose of vaccine to seven pt's . Prior to the administration of the vaccine she removed the dose divider clip thereby giving 0.50ml per nostril versus the prescribed dose of 0.25 ml per nostril. On 26Oct04, at 9:00 in the morning, the reporter gave a double dose of FluMist to a 26 year old female pt. Her medical history was not reported. The reporter stated the pt was achy, but did not report the onset time nor the outcome. No further information is available.									U	10/26/2004	10/26/2004	0		OTH	OTH	NONE				MEDI0002345	1						1	Medication error; Myalgia	FLUN3~MEDIMMUNE VACCINES, INC.~IN500336P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229928	12/02/2004	MD	38.0			F	10/28/2004	This is a non serious spontaneous case from a nurse of a medication error. The reporter causality was not provided to Flumist. A nurse reported a series of medication errors. The nurse misunderstood the dosing instructions for FluMist and administered a double dose of vaccine to seven pt's . Prior to the administration of the vaccine she removed the dose divider clip thereby giving 0.50ml per nostril versus the prescribed dose of 0.25 ml per nostril. On 26Oct04, at 9:00 in the morning, the reporter gave a double dose of FluMist to a 38 year old female pt whose medical history was not reported. The reporter stated the pt had chills with the onset time and outcome are unk. No further information is available.									U	10/26/2004	10/26/2004	0		OTH	OTH	NONE				MEDI0002348	1						1	Chills; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~IN500336P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229929	12/02/2004	MD	24.0			F	10/28/2004	This is a non serious spontaneous case from a nurse of a medication error. The reporter causality was not provided to Flumist. A nurse reported a series of medication errors. The nurse misunderstood the dosing instructions for FluMist and administered a double dose of vaccine to seven pt's . Prior to the administration of the vaccine she removed the dose divider clip thereby giving 0.50ml per nostril versus the prescribed dose of 0.25 ml per nostril. On 26Oct04, at 2:00 in the afternoon, reporter gave a double dose of FluMist to a 24 year old female pt whose medical history was not reported. The reporter stated the pt experienced headache, diarrhea and was sweaty by 6:30PM on 26Oct04. The pt's sweating and diarrhea resolved on 27Oct04 and as of 01Nov04 the pt continued to have mild headaches. No further information is available.									U	10/26/2004	10/26/2004	0		UNK	UNK	NONE				MEDI0002349	1						1	Diarrhoea; Headache; Hyperhidrosis; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~IN500336P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229930	12/02/2004	MD	25.0			F	10/28/2004	This is a non serious spontaneous case from a nurse of a medication error. The reporter causality was not provided to Flumist. A nurse reported a series of medication errors. The nurse misunderstood the dosing instructions for FluMist and administered a double dose of vaccine to seven pt's . Prior to the administration of the vaccine she removed the dose divider clip thereby giving 0.50ml per nostril versus the prescribed dose of 0.25 ml per nostril. On 26Oct04, at 4:00 in the afternoon, the reporter gave a double dose of FluMist to a 25 year old female pt whose medical history was not reported. The reporter stated the pt had no adverse events. No further information is available.									U	10/26/2004	10/26/2004	0		OTH	OTH	NONE				MEDI0002350	1						1	Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~IN500336P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229931	12/02/2004	WV	41.0			F	10/28/2004	This is a non serious spontaneous case from a nurse of a medication error. The reporter causality was not provided to Flumist. A nurse reported a series of medication errors. The nurse misunderstood the dosing instructions for FluMist and administered a double dose of vaccine to seven pt's . Prior to the administration of the vaccine she removed the dose divider clip thereby giving 0.50ml per nostril versus the prescribed dose of 0.25 ml per nostril. On 26Oct04, at 12:00 in the afternoon, the reporter gave a double dose of FluMist to a 41 year old female pt whose medical history was not reported. The reporter stated the pt had no adverse events. No further information is available.									U	10/26/2004	10/26/2004	0		OTH	OTH	NONE				MEDI0002351	1						1	Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~IN500336P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229932	12/02/2004	MD	47.0			F	10/28/2004	This is a non serious spontaneous case from a nurse of a medication error. The reporter causality was not provided to Flumist. A nurse reported a series of medication errors. The nurse misunderstood the dosing instructions for FluMist and administered a double dose of vaccine to seven pt's . Prior to the administration of the vaccine she removed the dose divider clip thereby giving 0.50ml per nostril versus the prescribed dose of 0.25 ml per nostril. On 26Oct04, at 11:00 in the morning, the reporter gave a double dose of FluMist to a 47 year old female pt whose medical history was not reported. The reporter stated the pt had no adverse events. No further information is available.									U	10/26/2004	10/26/2004	0		OTH	OTH	NONE				MEDI0002352	1						1	Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~IN500336P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229933	12/02/2004	MD	34.0			F	10/28/2004	This is a non serious spontaneous case from a nurse of a medication error. The reporter causality was not provided to Flumist. A nurse reported a series of medication errors. The nurse misunderstood the dosing instructions for FluMist and administered a double dose of vaccine to seven pt's . Prior to the administration of the vaccine she removed the dose divider clip thereby giving 0.50ml per nostril versus the prescribed dose of 0.25 ml per nostril. On 26Oct04, at 10:00 in the morning, the reporter gave a double dose of FluMist to a 34 year old female pt whose medical history was not reported. The reporter stated the pt had no adverse events. No further information is available.									U	10/26/2004	10/26/2004	0		OTH	OTH	NONE				MEDI0002353	1						1	Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~IN500336P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229934	12/02/2004	TX	38.0			F	11/01/2004	This is a not serious spontaneous case from a pharmacist of headache. The reporter causality is not provided to FluMist. A health professional reported headache, runny nose, nasal and head congestion after receiving her first dose of FluMist on 28Oct04. On the morning of 29Oct04 the reporter stated she had a headache, runny nose, and congestion. The reporter took ibuprofen for treatment and had some relief. The symptoms continue. No further information is available.									N	10/28/2004	10/29/2004	1		OTH	PVT	NONE		NONE		MEDI0002362	1						1	Headache; Nasal congestion; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~IN500333P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229935	12/02/2004	CA	50.0			F	11/01/2004	This is a non serious spontaneous case from a pharmacist of Burning Sensation in Eye. The reporter causality was not provided to FluMist. A pharmacist reported loss of voice, sore throat, runny nose, cough, the burning sensation in the left nostril, and eye area in a 50 year old female after receiving her first FluMist dose on 21Oct04. The reporter would not disclose the pt's history or contact information. On 26Oct04 the pt stated to the reporter that one day after receiving FluMist she had a burning sensation in her left nostril. She also had a runny nose and congestion which subsided by 29Oct04. On 29Oct04 the pt complained of cough, sore throat and loss of voice. The burning sensation in her nostril remained and had spread to her eye area. No further information is available.									N	10/21/2004	10/22/2004	1		OTH	PVT	NONE		NONE		MEDI0002364	1						1	Cough; Eye irritation; Laryngitis; Nasal congestion; Nasal discomfort; Pharyngolaryngeal pain; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~IN500335P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229936	12/02/2004	TN	49.0			M	11/11/2004	This is a not serious spontaneous case from a pharmacist of throbbing head. The reporter causality is not provided to FluMist. A pharmacist reported the complaint of a throbbing in the head in a 49 year old pt one day after receiving FluMist. The pt received FluMist on 02Nov04 at 8:30AM. The reporter stated the pt's head throbbing started at an unspecified time on 03Nov04 and has continued for almost a week. The pt's head would throb in five minute episodes.									N	11/02/2004	11/03/2004	1		OTH	OTH	Cholesterol Medication		NONE		MEDI0002401	1						1	Headache	FLUN3~MEDIMMUNE VACCINES, INC.~IN50033P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229937	12/02/2004	NC	50.0	50		F	11/16/2004	This is a non serious spontaneous case from a physician who reports a pt experienced influenza like symptoms after receiving FluMist. The reporter did not provide causality between events and FluMist. A female pt experienced flu like symptoms within 48 hours of receiving FluMist IN (date unknown). The pt recovered one week after the start of the events. The reporter did not provide causality between event and FluMist vaccination. Follow up 03/07/05: Lot number for vaccine not recorded.									Y	11/04/2004	11/06/2004	2		PVT	OTH	Allergy Med		Pollen Allergy, allergy shots within 4 weeks of receiving FluMist.		MEDI0002435	1						1	Influenza like illness	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229938	12/02/2004	TX	42.0	41		F	11/18/2004	This is a not serious spontaneous case from a consumer involving loss of smell. The reporter causality is not related to FluMist. A 41 year old female reported the loss of smell, loss of taste, and a sore throat three days after receiving one dose of FluMist. This female with the history of MRSA (Methicillin Resistant Staphylococcus aureus) infection and endocarditis received FluMist on 08Nov04 at 5:00PM. She had taken one dose of fluticasone propionate on the morning of 08Nov04. Her physician instructed her to discontinue the use of fluticasone propionate for one week after receiving FluMist. On 11Nov04 by 6:00PM, the reporter was not able to smell or taste anything. On 15Nov04, around lunch the reporter regained the ability to smell and taste without intervention. She stated on 15Nov04 she had a mild sore throat that she believed was due to sinus drainage. On 16Nov04 the reporter continued fluticasone propionate usage. She stated that the events were due to the discontinuance of the fluticasone propionate. No further information available.									Y	11/08/2004	11/11/2004	3		PVT	PVT	Flonase, Prozac, Klonopin, Birth control pills, Guaifenesin	Methicillin resistant, staphylococcal culture	S. aureus carrier, methicillin resistant, staphylococcus aureus (MRSA), past disease: endocarditis.		MEDI0002440	1						1	Ageusia; Anosmia; Pharyngolaryngeal pain; Sinusitis	FLUN3~MEDIMMUNE VACCINES, INC.~IN500337P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229939	12/02/2004	FL	1.12	1	.1	M	12/02/2004	Mom states he felt warm when I laid him down for a nap. Then I saw his body start shaking so I picked him up and his eyes rolled back in his head. I called 911; they took his temp but didn't tell me what it was. We took him to the ER. The doctor there said he had a ear infection and along with the shots, it probably caused the seizure. Seizure lasted 2-3 minutes and occurred only once. Parents are Spanish speaking only.				Y					Y	11/30/2004	12/01/2004	1		PUB	PUB	NONE	NONE	NONE			1						1	Convulsion; Eye movement disorder; Feeling hot; Infection; Tremor	DTAP~SANOFI PASTEUR~C1996AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1416AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0369P~3~IM~RL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~1186N~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A74398A~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0273P~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0229940	12/02/2004	CA	75.0	74		F	11/24/2004	Developed redness and swelling with pain at injection site within 24 hours of receiving injection in left deltoid.				Y					Y	10/24/2004	10/25/2004	1	MD exam; US of arm to rule out emodilus.	OTH	PVT		NONE	NONE			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1451AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229941	12/02/2004	WI	3.0	2	.9	M	11/09/2004	Within 24 hours of receiving vaccine during the evening of 10/05/04. Child was irritable, wetting pants (was potty trained) began throwing temper tantrums (e.g. hitting, kicking, screaming) although he had no loss of verbalization skills noted instead of asking for things, he pointed or motioned and when not understood he screamed. Generally this child is very active, verbal, pleasant, sleeps through the night and had been potty trained for over 2 months. The evening of 10/6/04 he slept poorly and for the next 14 days he slept sporadically but for no longer than 23 hours at a time. Other family members noted the sudden change in his behavior; aunts, uncles, grandmother, in addition to his parents. It was thought to be just another phase in this 34 month olds development. Although he has asthma, he is only treated with albuterol when ill. He was healthy on 10/10/04 with no signs/symptoms of URI, but was so hyperactive he choked, coughed and progressed to having an asthma attack requiring 2 nebulizer Rx. The parents didn't know exactly what to think until their other 2 children's teachers called wondering if something was amiss at home since their response in school was unusual during that 2 weeks. At that time, the parents spoke with child's pediatrician and then today called about the vaccine. There are trace amounts of thimerosal in this vaccine. They wondered if it was vaccine related. Today, child is beginning to calm, has begun sleeping through the night approximately 1 week ago, has begun using the toilet again for approximately 1 week, speech is clearer, calmer, no tantrums for approximately 1 week. He had pink peeling skin on the palms of his hands and soles of his feet for approximately 3-4 days between 10/15/04 and 10/25/04; bad enough the parents told a friend.  (Child had hand/foot/mouth disease 5/04. This redness and peeling was not like that.). Child also began tripping and falling during the period of 10/10/04 until 10/25/04 which the parents attributed to new shoes, but this clumsiness persisted when he was barefoot. As of 10/31/04, his pink peeling skin has resolved, his excessive clumsiness has resolved. Overall, he seems to be improving to pre-vaccine status. Note: Some of his temper tantrums during this period lasted for up to 45 minutes and stopped only when the child was exhausted.) Looking back, the child stopped his language progression for 4 weeks after each of his 2 flu vaccines in 2003									U	10/05/2004	10/05/2004	0	NONE	PUB	PUB	Albuterol	NONE	History of asthma.	~Influenza (Seasonal) (no brand name)~2~2.00~In Patient|autism~Measles + Mumps + Rubella (MMR II)~1~1.00~In Sibling		1						1	Abnormal behaviour; Aggression; Choking; Clumsiness; Condition aggravated; Cough; Injury; Insomnia; Irritability; Psychomotor hyperactivity; Skin exfoliation; Speech disorder; Urinary incontinence; Vasodilatation	FLU3~SANOFI PASTEUR~U1389AB~3~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229942	12/02/2004	TN		4		F	11/29/2004	Right thigh with 3 inch diameter erythema with non tender swollen area; itching.				Y					Y	11/24/2004	11/26/2004	2		PVT	UNK						1						1	Erythema; Pruritus; Swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~59289~5~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1380AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X0711~4~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0963N~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0229943	12/02/2004	CA	37.0	36		F	11/03/2004	Localized left deltoid pain 11/3/04 AM. Slightly red, swollen extending to posterior shoulder. Also noted small red area at adhesive band aid site.									U	11/03/2004	11/03/2004	0		PUB	UNK		NONE	Environmental allergies			1						1	Erythema; Swelling	FLU3~SANOFI PASTEUR~U1378AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229944	12/02/2004	PA	75.0	75		F	11/29/2004	Patient states that the evening of 11/17 or morning of 11/18, she began experiencing pain at the injection site. Pain is described as worse upon arising. She has pain with movement according to the patient (pulling her shirt over the head or fixing the bra). States pain is excruciating. Never had redness, lump or discoloration at injection site. Has not taken any pain medications. Now used ice compress. Advised to call doctor. OTC analgesic, warm compress.									N	11/17/2004	11/17/2004	0	NONE	PUB	PVT	Lipitor; Synthroid; Evista; Clonazepam	NONE	Hypercholesterolemia; Hypothyroid; Panic attacks			1						1	Hypokinesia; Injection site pain; Pain	FLU3~SANOFI PASTEUR~U1532AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229945	12/02/2004	CA	1.5			M	11/24/2004	Right deltoid IM injection. Crying, fussy, immediate 2 diameter redness with swelling around injection site. 4 drops of blood wiped away.									Y	11/23/2004	11/23/2004	0	NONE	PVT	PVT	NONE	Congestion	NONE			1						1	Crying; Injection site erythema; Injection site swelling; Irritability	DTAP~GLAXOSMITHKLINE BIOLOGICALS~632A2~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1579AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A57561K~4~IM~RA~PNEUMO (PREVNAR)~1	USA		Influenza
0229949	12/02/2004	ME		1	.1	M		Chief Complaint: Fever. Subjective: Patient has had a fever for the past one and a half days now, and mom also noticed a rash that seems to be spreading; this started last night. His temperature has maxed to 104. Parents have also noticed that his appetite has been decreased. He has been sleeping a lot more than usual and is less active than usual. He has had no vomiting and no diarrhea recently, although last week he did have diarrhea. He has had a cough and cold for the past two weeks. His runny nose actually has been worse and is thicker and greenish. He has been tugging his left ear and has been fussy. He just got over an ear infection during the first week of November. He had his immunizations 10 days ago. He received MMR, Varivax, and DTaP. The rash is blanching but does not appear to cause any discomfort or itching. Allergies: He has no known drug allergies. Objective: General: On exam, he is alert, in no acute distress. His temperature today is 98.4. Comfortable, playful. Skin: He has a maculopapular erythematous blanching rash scattered over his trunk and upper extremities. None on the palms or soles. HEENT: The right TM is mildly erythematous, otherwise normal light reflex and mobility. The left is bulging and opaque with absent landmarks. Eyes are not injected. No discharge. Nares with thick rhinorrhea. Oropharynx normal. No oral lesions. Neck: Supple. No Mass. Chest/Lungs: Clear to auscultation bilaterally. Heart: Regular rate and rhythm. No murmur. Abdomen: Soft and nontender. No hepatosplenomegaly. Assessment: Fever and rash, most likely secondary to MMR. He also has a concomitant prolonged upper respiratory infection, which could be sinusitis given the current fever. He also had a left otitis media.									Y	11/18/2004	11/20/2004	2	NONE	PVT	PUB		NONE			ME0408	1						1	Decreased appetite; Diarrhoea; Pharyngitis; Pyrexia; Rash erythematous; Rash maculo-papular; Rhinitis; Rhinorrhoea; Somnolence	DTAP~SANOFI PASTEUR~U1307CA~4~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1379AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0961N~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0186P~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0229960	12/03/2004	NE	49.0	49		M	12/03/2004	Started with soreness in arm during the first 12 hours.  Resulted in Cellulitis below the injection site, and caused extreme pain in the whole arm at about the 24 hour period.  Pt was seen in the ER, and received antibiotics such as Levaquin 750 mg.				Y					U	12/01/2004	12/03/2004	2		MIL	OTH	Detrol 1.5 tablets Qday Cough syrup with codeine	Virus, URI	Mulitiple Sclerosis			1						1	Cellulitis; Pain	FLU3~SANOFI PASTEUR~U1515AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0864N~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0229961	12/03/2004	DE	48.0	48		F	12/03/2004	Symptoms developed the morning of 11/20/04 and lasted until 11/23/04.  Pt c/o congestion, earache, muscle aches and low grade fever.  Pt developed hives on Saturday afternoon.  Pt reports taking Benadryl and the hives subsided 1 hour later.  Pt reports hives reoccurred on Sunday am 11/21/04 and again subsided after taking Benadryl.  Pt reports feeling heat behind knees and on elbows which lasted approx. 2 hours.  Pt reports that symptoms									Y	11/19/2004	11/20/2004	1		UNK	UNK	none	none	none			1						1	Ear pain; Feeling hot; Myalgia; Nasal congestion; Pyrexia; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500340P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229962	12/03/2004	VA	78.0	78		F	12/03/2004	6 days following flu shot had onset of pain beginning at top of shoulders & extending to both arms & up back of neck - great difficulty lifting arms & head, as well as difficulty coughing.  Interfered with sleeping.  Denied wheezing, SOB, hives or reddness. Self medicated with Tylenol Q2-3 hours.  Started resolving in 2 days, completely resolved after 4 days. Did not contact MD or seek other medical treatment.									Y	11/17/2004	11/23/2004	6	N/A	UNK	UNK	Unknown	None	Unknown; no known allergies to components of flu vaccine			1						1	Cough; Hypokinesia; Neck pain; Pain; Shoulder pain; Sleep disorder	FLU3~SANOFI PASTEUR~U1448AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229965	12/03/2004	WA	81.0	80		M	12/03/2004	About several hours the patient received a flu vaccine, he felt dizzy. He then felt like he couldn't control his hands or feet and had trouble walking. Over the next week he felt like he had a flu like illness with nausea and diarrhea. It gradually improved, though he still felt like his balance was off when I saw him today. I wonder whether he had a Guillain-Barre like reaction.									U	10/06/2004	10/06/2004	0	11/24/04 WBC 6.9, Hg 13.3, Hct 38.9, Plt 191 CMP normal other than a slightly elevated BUN of 28. TSH 2.2, lipoprotein (a) 13 mg/dL.	UNK	UNK	nortriptyline, Benicar, Pepcid, Pravachol, Flomax, Glucovance, folic acid, Avodart, Diltia XT, aspirin, glucosamine-chondroitan	none	Type 2 diabetes mellitus, ASCAD, hypertension, hyperlipidemia, homocystinemia, GERD. Allergies - amoxicillin, quinapril, codeine. He quit smoking in 1957 and has had rare alcohol in the past.			1						1	Diarrhoea; Difficulty in walking; Dizziness; Hypokinesia; Influenza like illness; Laboratory test abnormal; Nausea	FLU3~SANOFI PASTEUR~U1410BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229978	12/03/2004	AL	77.0	76		M	11/29/2004	Patient died within 48 hours of being given flu vaccine. Cause of death CHF and bronchitis. Patient sick with chest congestion prior to vaccine per niece. Hospitalized 11/18/04. Previous history of CHF.	Y	11/18/2004							N	11/16/2004	11/18/2004	2		PUB	UNK	UNK	Chest Congestion	History of CHF. Discharge Summary received on 12/15/2004 states pt has a history of HTN, TIA, Cartoid Stenosis, Hyperlipidemia, Leukemia and Hyponatremia.		AL0427	1						1	Bronchitis; Cardiac failure congestive; Condition aggravated	FLU3~SANOFI PASTEUR~U1439AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0229979	12/03/2004	CA	1.4	1	.4	F	12/03/2004	Seizure lasting seconds in parking lot, witnessed by grandparents.				Y					Y	12/03/2004	12/03/2004	0	Oxygen saturation initially 94%-100% with oxygen	PVT	UNK	NONE	Afebrile, history of diarrhea	possible mile allergy			1						1	Convulsion	FLU3~SANOFI PASTEUR~U1454AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0229980	12/03/2004	CA	48.0	48		M	11/17/2004	This is a non-serious case from a consumer in the USA who developed chest congestion after receiving FLUMIST. The reporter did not provide causality between events and FLUMIST administration. Approximately 30 minutes after receiving FLUMIST on 11/11/04, a 48 year old male developed chest congestion and started coughing. The patient reports sleeping all day and stay awake only 6-8 hours a day. The patient also experienced wheezing, weakness, and a dry nasal cavity. He has not gone to the doctor as of yet. All events are ongoing but at the time of the report, he says he is feeling better. The patient's medical history is unremarkable.									N	11/11/2004	11/11/2004	0	NONE	UNK	UNK	NONE		NONE		MEDI0002441	1						1	Asthenia; Cough; Nasal congestion; Nasal dryness; Somnolence; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500337P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229981	12/03/2004	OR	40.0	40		F	11/15/2004	This is a non serious case from a nurse in the USA of involving cough. The reporter causality is not reported to FluMist. The case qualifies for accelerated reporting. This patient is a 40 year old female who received a dose of FluMist on 11/10/04. On the first evening after receiving FluMist, she reports developing a severe sore throat that kept her up all night. On 11/11/04, she reports developed a cough. On 11/12/04, she says she is feeling better but continued with cough, weakness, and fatigue and states she feels tired and completely wiped out. We have no medical history on this patient and no concomitant medications were reported. The patient reported feeling completely recovered as of 11/19/04. The patient also states that her daughter has some of the same symptoms and we are awaiting clarification as to whether the child received FluMist or if this would qualify as a case of accidental exposure.									Y	11/10/2004	11/10/2004	0		OTH	PVT	NONE		NONE		MEDI0002477	1						1	Asthenia; Cough; Fatigue; Insomnia; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~500336P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0229982	12/03/2004	VA				U		Right arm erythema/induration 4x4 cm: warm to touch/ raised and malaise and watery eyes and rhinitis.									Y	11/09/2004	11/09/2004	0		PUB	UNK		NONE				1						1	Erythema; Feeling hot; Injection site induration; Injection site swelling; Lacrimation increased; Malaise; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0229983	12/03/2004	KY	40.0	40		F	11/30/2004	10/8/04: tongue swelled 10/9 swelling mouth/lips. 10/13: lip jaw right side. 10/15: upper lip jaw. 10/22: right finger 10/28: bottom lip. 11/11: eye. 11/17:lip. 11/18 tongue. 11/27:lip jaw. 11/29: left eye. Still under care									U	10/06/2004	10/08/2004	2	Blood work, Referral to allergist. Still testing.	PVT	UNK	Ambien, Birth control	NONE	NONE			1						1	Eye swelling; Swelling; Swelling face; Tongue oedema	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0229985	12/03/2004	OH	53.0	53		F	12/03/2004	11/22/04: approximate time 18:00 pm Fluzone 0.5IM given deltoid; employee reported 12 hours later, she developed rash and itching starting with her feet. She also reported this incident 12/2/04. Self medicated Benadryl and Medral dose									Y	11/22/2004	11/22/2004	0	Allergic to Fluzone vaccine	UNK	UNK		NONE	History of Allergies per her report			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U151BAA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229966	12/04/2004	FL	52.0	52		M	12/04/2004	MUSCLE AND JOINTS SWELLING, STIFFNESS AND ACHING, ELEVATED BLOOD PRESSURE, SLEEP DEPREVATION, IRRITABILITY, ARTHRITIC TYPE JOINT PAINS TO SPINAL REGION-SHOULDER-KNEES AND ANKLES, NUMBNESS TO RIGHT FRONTAL FOOT AND GREAT TOE, ATTENTION DEFICIT DISORDER, LOSS OF MEMORY, AND NIGHT SWEATS, STRESS ISSUES, INCREASE IN HIGH PITCHED TINNITUS.			Y	Y				Y	N	02/08/2003	01/25/2003		Doctor consulted and prescribed medications	MIL	MIL	Klonopin - 0.5MIL - Sleep Issues Accuprell - Blood Pressure	None - Excellent Health - Just had physcial	None			1						1	Amnesia; Arthralgia; Blood pressure increased; Condition aggravated; Hypoaesthesia; Insomnia; Irritability; Joint stiffness; Joint swelling; Myalgia; Night sweats; Thinking abnormal; Tinnitus	ANTH~EMERGENT BIOSOLUTIONS~FAV080~5~IM~RA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~765424~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4020071~1~~LA~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~U1073~5~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Life Threatening,Disabling	Influenza
0229967	12/05/2004	CA	32.0	31		F	12/05/2004	Swollen, red, inflamed area around right eye. Quarter to sand dollar sized rash patches on stomach, breasts, back and legs. Extremely itchy. Hands are extremely itchy, but no rash visible.									Y	12/03/2004	12/04/2004	1		UNK	UNK	Advair	None	Asthma, allegic rhinitis			1						1	Erythema; Eye swelling; Pruritus; Rash	FLU3~SANOFI PASTEUR~U1556AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229968	12/05/2004		23.0	23		M	12/05/2004	Several hours after administration, pt became lethargic and febrile experiencing myalgias and arthralgias. He was given antipyretic, anti-inflammatories and sent home from work.  After no improvement in symptoms and development of productive cough, he reported again 48 hours later where CXR revealed a right lower lobe air space process.  He was uneventfully treated for pneumonia and recovered completely.				Y					Y	11/10/2004	11/10/2004	0	CXR on 11/13/04 showed right lower lobe airspace process	MIL	MIL	none	none	none	fever, myalgias~Influenza (Seasonal) (no brand name)~~0.00~Patient		1						1	Arthralgia; Cough; Laboratory test abnormal; Lethargy; Lobar pneumonia; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1457AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0230013	12/06/2004	CA	35.0	34		F	12/06/2004	Approximately two days after flu mist received, I had flu symptoms of sneezing, runny nose, headache, sore throat.  Symptoms worsened to include chest and ear pain, joint pain, and dizziness over the next few days, and then a cough.  All symptoms liveable with over the counter medications.  Biggest problem is that flu mist was recommended since I have a 4 month old daughter who could not be vaccinated, but now I am very contagious and coughing and sneezing.  I don't understand why it was recommended for me to get the flu mist to protect my daughter when it is creating a problem that otherwise might not have existed.    I'm still sick so I don't know how this will end, but it feels very much like I just have an ordinary miserable case of the flu, so I expect it to run its course.									U	12/01/2004	12/03/2004	2		UNK	UNK		none	none			1						1	Arthralgia; Chest pain; Cough; Dizziness; Headache; Influenza like illness; Pharyngolaryngeal pain; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0230028	12/06/2004	WI	63.0	63		M	11/16/2004	It has not been determined if the flu shot on 10/15/04 is correlated with patient's current illness. On 10/27/04, clinic was informed that the doctor was requesting information regarding when he had his flu shot. Information provided to infection control per clinic. On 10/28/04, infection control reported patient is currently hospitalized with headache, nausea/vomiting, hypertension, possible migraine symptoms. He has no fever and no localized reaction at injection site (for flu shot) per infection control. Write called VAERS and spoke with HIS who stated the physician can call another phone number to see if the flu shot could have any correlation to the patient's current signs and symptoms which required hospitalization. Called nurse in family practice (no answer) and informed her of the VAERS phone number. Nurse reported she would give this information to the doctor. On 11/02/04, writer emailed doctor inquiring if there is a correlation between flu shot and patient's condition. As of 11/16/04, no response from the doctor. Patient reported to writer on 11/12/04 that he was having trouble with balance and has been falling. Patient states doctor did not think his illness is related to the flu shot he got on 10/15/04. Medical records received on 1/25/2005 states pt experienced dizziness and fatigue. Follow up 03/08/2005: The main syptoms of the adverse event were dinzziness, fatigue and decreased memory that occurred 13 dayas after vaccintation. The patient was diagnosed with subacute vertigo with no evidence of peripheral vestibulopathy. Records mention previous episodes over the past 3 to 4 months but worse now. Follow up 02/11/05: The employee health does not have any updates, please contact patient's physician.					Y				U	10/15/2004	10/28/2004	13	Not known.	PUB	PVT	UNK	NONE	UNK. Medical Records received on 1/25/2005 states hypertension, hypercholestermia, GERD, allergy, dizziness, and decreased memory.			1						1	Balance disorder; Dizziness; Fall; Fatigue; Headache; Hypertension; Migraine; Nausea; Vertigo; Vomiting	FLU3~SANOFI PASTEUR~U1380AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0230029	12/06/2004	MO	17.0	16		M	11/27/2004	Patient given flu vaccine 11/11/04. Within 24-36 hours, erythema/induration, fever. Initially observed with supportive care. Next 24-48 hours, continued fever, increased spread of erythema, induration - indicative of cellulitis. Medical Record received on 1/3/2005 states vomiting.				Y	Y	4			Y	11/11/2004	11/12/2004	1	Increased CBC; Negative BC; No organism recovered; Cellulitis with no abscess or septicemia. Medical Record received on 1/3/2005 states pt did not experience cellulitis.	PVT	PVT	Advair BID, Albuterol PRN for RAD	NONE	Allergic Rhinitis; Well controlled mild intermittent RAD.			1						1	Injection site erythema; Injection site induration; Laboratory test abnormal; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1458AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0287P~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0230033	12/06/2004	OH	65.0	64		F	12/06/2004	12/2/04 1-1 1/2 hours after receiving vaccine pt states arm swelled from shoulder to elbow, became red and painful. 12/3/04 worse. Pt went to ER. Was Tx with ATB for bacterial infection/ cellulitis.				Y					U	12/02/2004	12/02/2004	0		PUB	PVT		NONE	NKA, H/O diabetes, takes insulin/glucophage			1						1	Bacterial infection; Cellulitis; Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U1459AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0692P~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0230034	12/06/2004	OH	69.0	68		F	12/03/2004	Pt called on 12/03/2004 1PM c/o redness, pain, swelling rt arm from shoulder to elbow. States sx started yesterday evening and worsened today. Pt advised to call PCP immediately.				Y					U	12/02/2004	12/02/2004	0	Seen in ER 12/03/04 Tx with ATB for cellulitis	PUB	PVT		NONE	States breaks out in rash when stainless steel touches skin			1						1	Cellulitis; Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U1459AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0692P~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0230035	12/06/2004	MD	10.0	10		F	12/03/2004	Urticarial rash over right hip, on left arm, and chest.									Y	12/01/2004	12/02/2004	1	NONE	PVT	UNK		NONE	Allergic to Amoxicillin			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1425AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230036	12/06/2004	WI	30.0	30		F	11/30/2004	Client indicated approx 1 hr s/p influenza vaccination on 11/18/04 her face became flushed, face felt hot. Temp normal. No itching or edema. Symptoms resolved within 3-4 hours.									Y	11/18/2004	11/18/2004	0	NONE	PUB	PVT						1						1	Feeling hot; Flushing	FLU3~SANOFI PASTEUR~U1381AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230039	12/06/2004	GA	18.0	18		F	12/01/2004	Edema 8cm 2nd and 3rd day after immunization was given.									Y	11/19/2004	11/21/2004	2	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Injection site oedema	FLU3~SANOFI PASTEUR~U1499AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~AVENTIS PASTEUR~U1186AA~1~~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0230040	12/06/2004	WA	42.0	41		F	11/23/2004	Pt seen in ER 1 day following administration of Pneumovax Right arm SC. Dx. cellulitis and placed on Abx.									Y	10/29/2004	10/30/2004	1		PVT	UNK		Post viral cough	Turner's syndrome, Behet syndrome, hypertension.			1						1	Cellulitis; Injection site reaction	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1201N~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0230041	12/06/2004	CA	81.0	80		F	11/24/2004	Facial swelling and shortness of breath, sleepy. Pt referred to ER. Pt received vaccine previously.				Y					U	11/23/2004	11/23/2004	0		PUB	PUB			Asbestos exposure, deaf			1						1	Dyspnoea; Face oedema; Somnolence	FLU3~SANOFI PASTEUR~U1519AB~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0230042	12/06/2004	LA	79.0	78		F	11/24/2004	Severe bruising from shoulder to elbow of left arm. Saw Dr on 11/19/04 and was told needle hit a blood vessel and would go away on its own. Reports no pain or swelling.				Y					Y	11/16/2004	11/17/2004	1	NONE	PUB	PUB	Nasonex, Zyrtec as needed	NONE	Sinus infections frequently		LA041205	1						1	Contusion	FLU3~SANOFI PASTEUR~U11499AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0230043	12/06/2004	LA	77.0	77		F	11/24/2004	At approx 1PM began to have fever and chills, nausea, took acetaminophen shortly after, fever decreased, started with joint pain, this continued until approximately 3PM 11/24/04.									Y	11/23/2004	11/23/2004	0	NONE	PUB	PUB		NONE	NONE		LA041204	1						1	Arthralgia; Chills; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~U1531AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230044	12/06/2004	MI	14.0	14		F	12/02/2004	Muscle aches and pains, numbness at times. 6 days after flu vaccine at ped neurology. Ibuprofen or Stilazin, or Naproxen. Discharge Summary received on 1/06/2005 states headache.				Y					U	10/19/2004	10/20/2004	1	CBC diff, Sed rate, ANA, CPK, Lytos, Thyroid, UA, EKG, AP factor.	PVT	PVT	Ibuprofen, Stilazin, Naproxen	NONE	Allergic Rhinitis, Asthma			1						1	Headache; Hypoaesthesia; Myalgia	FLU3~SANOFI PASTEUR~U1499AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0230045	12/06/2004	MA	82.0	82		F	11/19/2004	Pruritic, maculopapular rash, covering torso, arms, extremities and face. Rx with Benadryl if needed									U	11/15/2004	11/16/2004	1		PUB	OTH	Lesrol, Lorazepam, Oscal, Norvasc, Cozaar, Dyazide, Lotrisone cream	NONE	Fosamax, beta blockers, aceuhib, IVP dye, Lactose, intol niacin, flushing		MA0403	1						1	Pruritus; Rash maculo-papular	FLU3~SANOFI PASTEUR~U1454AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230046	12/06/2004	MA	75.0	74		F	11/19/2004	Localized area of redness, warm to touch									U	11/16/2004	11/17/2004	1		PUB	OTH	Atenolol, hydralying, aspiring, mult vit bid.	NONE	NONE		MA0402	1						1	Feeling hot; Injection site erythema	FLU3~SANOFI PASTEUR~U1454AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230047	12/06/2004	AZ	77.0	76		F	11/30/2004	Hands and fingers swollen and pain on movement. Little strength in hands and wrists. Lasting so far 2 months. Dx: Tendonitis. Given physical therapy with some improvement seen.				Y					Y	10/01/2004	10/03/2004	2		OTH	UNK		NONE				1						1	Hypokinesia; Oedema; Pain; Tendonitis	FLU3~SANOFI PASTEUR~~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0230048	12/06/2004	OR	62.0	61		M	11/30/2004	Pain at injection site, right shoulder right side of neck. Right side of back, burning sensation. Chemo Tx earlier injections 11/10/04.									Y	11/12/2004	11/12/2004	0	NONE	PUB	OTH	Chemo, Enalapril, Lasik, Actos, Prevacid, Celebrex, Vicodin, Lipitor.	NONE	DM			1						1	Injection site pain; Skin burning sensation	FLU3~SANOFI PASTEUR~U1496AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230049	12/06/2004	IN	1.24	1	.2	M	11/24/2004	Woke up at 6AM, felt warm to dad. Grand mal seizure x 3-4 minutes with 2hr postictal state followed by complete return to baseline in 3hrs post seizure. Medical Record received on 1/3/2005 states fever.				Y					Y	11/23/2004	11/24/2004	1	CBC nl, Bld cx negative, chem 14, elevated alk phos, UA nl, CXR nl. Medical Record received on 1/3/2005 states lab test abnormal.	PVT	PVT		Nasal Congestion	Medical Record received on 1/3/2005 states diarrhea.			1						1	Feeling hot; Grand mal convulsion; Laboratory test abnormal; Postictal state; Pyrexia	DTAP~GLAXOSMITHKLINE BIOLOGICALS~A632B2~4~~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1500AA~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE335AC~4~~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A7447DC~4~~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0230050	12/06/2004	WI	29.0	28		F	11/24/2004	11/15/2004, Received flu shot, 11/16/04, achy, cough, congested head, 11/17/04 diarrhea, head cold changed to chest cold. Cough up phlegm, tired/hot, 11/18/04 felt better, continued with cough, 11/19/04 diarrhea returned, hot, no upset stomach, 11/19/04 woke up hot, burning up with slight diaphoresis. Does not have a thermometer. Called her provider on 11/18/2004.									U	11/15/2004	11/16/2004	1	NONE	PUB	PVT	BCP	NONE	Denies allergies (seasonal/pollen)	Reported flu like symptoms, welt~Varicella (no brand name)~1~0.00~In Patient		1						1	Cough; Diarrhoea; Fatigue; Feeling hot; Hyperhidrosis; Nasal congestion; Pain; Rhinitis	FLU3~SANOFI PASTEUR~UI380AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230068	12/06/2004	FL	1.3	1	.3	F	11/22/2004	Child came in on 11/22/04 with rash and fever. Mom stated started 3 days ago, rash? Roseola or Rubella 2 to MMR, Fever 102 x2 days, decreased fever and rash.									Y	11/09/2004	11/19/2004	10		PVT	OTH						1						1	Pyrexia; Rash	DTAP~SANOFI PASTEUR~U1314DA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1416AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE313AA~4~IM~LL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0041P~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~495722~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0229633	12/07/2004	CA	80.0	80		F	11/23/2004	Morning after flu vaccine and Remicade injections, patient woke with loss of strength in legs; became worse with ascending weakness and numbness., heaviness in arms				Y	Y	2			Y	11/09/2004	11/10/2004	1	Negative spinal fluid analysis; Normal MRI brain and cervical spine; Normal labs.	PVT	PVT	Remicade; Fosamax, Vicodin, Folate, HCT2, Clinazepam, Methotexa	Rheumatoid arthritis	Tobacco use; Rheumatoid arthritis; Peripheral neuropathies.			1						2	Anaemia; Asthenia; Dysuria; Laboratory test abnormal; Pain; Sensation of heaviness; Hypoaesthesia; Muscular weakness	FLU3~SANOFI PASTEUR~V1449AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~V1449AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0230097	12/07/2004	MD	65.0	65		F	12/02/2004	11/20/04 1pm pain right shoulder where shot administered swellings and swollen down to elbow. On Monday some swelling down yellow streak down toward arm pit. Red streak under near arm pit. 4-5 inches long appear under skin blood PMD states. Treated with ice x 2 days. Heat on third day.				Y					Y	11/20/2004	11/20/2004	0		PUB	PUB	ASA	Post CVA and EGD in 1999				1						1	Cellulitis; Erythema; Haematoma; Injection site pain; Pain; Rash macular; Skin discolouration; Swelling	FLU3~SANOFI PASTEUR~U1527AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0691P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0230098	12/07/2004	MD	57.0	56		M		Vaccination Monday, 22nd.  Itching and stiffness Tuesday. Down from arms big red swelling. to ER.				Y					Y	11/22/2004	11/23/2004	1		PUB	PUB	Lisinopril, Glypzole, Zocor	NIDDM, HTN, increase Cholesterol, Asthma	NIDDM, HTN, increase Cholesterol, Asthma			1						1	Erythema; Musculoskeletal stiffness; Oedema; Pruritus	FLU3~SANOFI PASTEUR~U1521AB~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0691P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0230099	12/07/2004	WI	51.0	50		F	12/07/2004	Had typical flu symptoms after vaccination, including severe chills, nauseous, achy, weak. Cant remember when had flu last. Stayed in bed night, almost fainted in morning, but probably because he did not eat much. But now feels okay.									Y	12/06/2004	12/06/2004	0		PVT	OTH	Synthroid, Clarinex, Lipitor, Nasonex, Medroxyprogesterone		Allergies (dust, pollen animals, feathers, grass)			1						1	Asthenia; Chills; Decreased appetite; Nausea; Pain	FLU3~SANOFI PASTEUR~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230100	12/07/2004	OH	70.0	69		F	12/08/2004	11/18/04: Patient noted scab and redness at left deltoid. Applied Polymyxin to site. After application of Polymyxin, pruritic rash developed at site, spread to elbow under arm. Saw dermatologist for rash 11/23/04. Dermatologist could not determine cause of rash, ordered cutivate which worsened rash. Went to urgent care 11/27/04 for rash. Cutivate dc'd . Rash resolved 12/10/04.				Y					Y	11/16/2004	11/18/2004	2		PUB	PUB			Allergy: Sulfa, Prednisone, Neosporin			1						1	Erythema; Injection site reaction; Rash pruritic; Skin reaction	FLU3~SANOFI PASTEUR~U1459AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0230101	12/07/2004	WV	51.0	50		F	11/29/2004	Approximately 45 minutes after injection, had numbness and tingling to face, nose, lips, right arm felt heavy, had increased heart rate, felt clammy and sweaty. Symptoms lasted 3 hours. Has had similar reactions to Cortisone shots and allergy shots.									Y	11/24/2004	11/24/2004	0		UNK	PUB	Benadryl, Tylenol, PRN, Conat calcium qd, Cortisone injections q3-6		Allergic to PPD, IVP dye, ? antibiotic, grass, hay, straw, IS Lupus carrier, has heel sours.		WV0408	1						1	Cold sweat; Hyperhidrosis; Hypoaesthesia; Paraesthesia; Sensation of heaviness; Tachycardia	FLU3~SANOFI PASTEUR~U1527AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230102	12/07/2004	VA	0.53	0	.5	F	12/02/2004	Urticaria lower face, a few additional isolated lesions on ears, wrist, leg. Information from medical record states allergic reaction. msv									Y	11/30/2004	11/30/2004	0	Has appointment with allergist 1/4/05, to be tested for egg, flu vaccine reaction. Others to follow as needed.	PVT	PUB			Left hearing deficit, Both hip dysplasia Infromation from Medical record states depression. msv			1						1	Rash; Skin ulcer; Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~632B2~3~~~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1468AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~W0704~3~~~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~A83578D~3~~~PNEUMO (PREVNAR)~1	USA		Influenza
0230104	12/07/2004	MN	1.02	1	.0	M	12/01/2004	1. high fever 104degrees F x 45day with irritability. 2. Measles type systemic rash as the fever resolved. 3. Negative blood cultures.									Y	11/17/2004	11/24/2004	7	Normal CBC, though left shift, Negative blood cultures	PVT	UNK			Right elbow and forearm fracture, in cast			1						1	Irritability; Pyrexia; Rash morbilliform	DT~MASS. PUB HLTH BIOL LAB~0290[~1~~LL~DT ADSORBED (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1530A6~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0095P~3~~RA~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0781P~1~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0230105	12/07/2004	IA		36		F	11/29/2004	Patient stated given flumist on 11/24/04. Stated on 11/25/04 developed red pimple area on stomach, arms, and thighs, when scratched became welts.									Y	11/24/2004	11/25/2004	1		PVT	PUB						1						1	Rash; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500339P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0230106	12/07/2004	TX	75.0	75		F	12/06/2004	Swelling size of child's football. Red, feverish, hard knot, itched, sore: it was like the pneumococcal shot that reacted left arm had flu shot the week before in same arm.									Y	11/30/2004	11/30/2004	0		UNK	UNK						1						1	Erythema; Injection site induration; Pruritus; Pyrexia; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U1457AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0946N~UNK~~~PNEUMO (PNEUMOVAX)~1|TD~AVENTIS PASTEUR~U1283AA~UNK~~~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0230107	12/07/2004	TN	86.0	85		M	11/29/2004	Arm and neck swollen and hurting. Also hurting in rib cage. Had nausea and vomiting. Began over the weekend after shot. Symptoms eventually improved.									Y	10/08/2004	10/09/2004	1		OTH	UNK						1						1	Nausea; Neck pain; Pain; Swelling; Vomiting	FLU3~SANOFI PASTEUR~U1440AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230108	12/07/2004	MT	17.0	16		F	12/01/2004	Pt was given Flumist and was pregnant. Pt did not tell me she was prior to vaccination.									U	11/17/2004				PVT	UNK						1						1	Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~500338P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0230109	12/07/2004	OR	75.0	75		F	11/23/2004	Injection site: bright red, size of quarter, arm ached, very tender. Experienced malaise, fatigue, low grade fever, headache. Started on Thursday through the weekend, worse on Monday. Took one week to clear.									Y	11/11/2004	11/11/2004	0		UNK	UNK			Allergy to dust, pollens			1						1	Erythema; Fatigue; Headache; Malaise; Pain; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~U1500AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230110	12/07/2004	OH	9.0	8		F	12/02/2004	Cough, rhinorrhea and fever (Temp 104) x 5 days. Seen 12/2/04 (10 days after vaccine) and Dx'd with pneumonia PE significant for aspirators crackle at lt base.									U	11/22/2004	12/02/2004	10		PVT	PVT						1						1	Cough; Pneumonia aspiration; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500338P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0230111	12/07/2004	IN	75.0	74		F	12/01/2004	States arm started getting sore that night. Was painful, red, and swollen to elbow next day 11/30/04 went to Dr. He reported to her had infection in arm. Something was dirty, tightly swollen to elbow. Started on Cephalex in 50mg tid x10days and Medrol Dose pack x 6 days. I talked to Dr's office and they did not say dirty, said possible cellulitis infection.				Y					Y	11/29/2004	11/29/2004	0		PUB	PUB		NONE	NONE			1						1	Cellulitis; Erythema; Infection; Oedema; Pain	FLU3~SANOFI PASTEUR~U15598BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0945N~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0230112	12/07/2004	NY	38.0	37		F	12/02/2004	Administered FluMist after review, returned in 30-45 min c/o sore throat and nasal congestion. Discussed symptomatic relief. Returned an hour later c/o hives, felt throat swollen. To Emergency Dept. Given Benadryl 50mg PO, Prednisone 40mg PO and Tylenol 650 mg PO with relief 12/2/04 at work. Feels great! ER summary states diarrhea, abdominal cramps, headache. msv				Y					Y	12/01/2004	12/01/2004	0	+ Leukocytes in UA Urine culture obtained.	PVT	PVT	Paxil, Darvocet	NONE	IVP dye, hives, S/P hysterectomy, migraine headaches, stroke 4/04, renal stone			1						1	Abdominal pain; Diarrhoea; Headache; Laboratory test abnormal; Laryngospasm; Nasal congestion; Oedema; Pharyngolaryngeal pain; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500340P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0230113	12/07/2004	GA	70.0	69		M	11/23/2004	11/23/04 Had Fluzone around 9:30AM. Noticed whelp like blisters on left forearm within 6-9 hrs in left arm, with itching which has spread upward and downward through the night and the next day. 11/29/04 pt into clinic, rash had worsened progressing to left hand and back with inflamed pustular areas, saw PMD and was treated with Valtrex which was successful.									Y	11/22/2004	11/22/2004	0	NONE	PUB	PUB	Nemenden, Lipitor, Others but not sure of names.	Acute chronic emphysema	Bee stings, emphysema, high cholesterol			1						1	Blister; Pruritus; Rash pustular; Urticaria	FLU3~SANOFI PASTEUR~U1553AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230114	12/07/2004	MA	0.53	0	.5	F	12/01/2004	Full body rash				Y					Y	11/30/2004	12/01/2004	1		PVT	PUB		NONE				1						1	Rash	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A001AA~3~~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1452AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE335AB~3~~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A79659F~3~~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0230115	12/07/2004	OK	73.0	73		F	11/30/2004	Per pt swollen right arm, very large red welt lasting 5 days.									Y	10/26/2004	10/27/2004	1		PVT	PVT	Many					1						1	Injection site oedema; Urticaria	FLU3~SANOFI PASTEUR~U1441AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0490P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0230116	12/07/2004	AR	26.0	25		M	11/30/2004	Became congested (lungs) then to ears, itching and headaches. Saw doctor 11/29/04 and tx as below.				Y					Y	11/10/2004	11/16/2004	6	Sulfa, Amoxicillin, Darvocet, injection at doctor.	OTH	PUB		NONE	Allergies to feathers, sulfa			1						1	Headache; Lung disorder; Pruritus	FLU3~SANOFI PASTEUR~U1512AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0230117	12/07/2004	IL	1.63	1	.6	M	12/03/2004	2 days after immunizations the child was brought back to clinic mod. edema entire left thigh, no limp, skin sl. discolored. Deeper pink than right, pruritic left thigh.									Y	11/29/2004	11/30/2004	1		PVT	PUB	Bactrim	NONE	Solitary left kidney, no current UTI's			1						1	Injection site erythema; Injection site oedema; Pruritus; Skin discolouration	FLU3~SANOFI PASTEUR~U1416AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A74398A~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0230118	12/07/2004	FL	75.0	74		F	11/16/2004	I awoke at 2 or 3 AM, dizzy-room going around. Stayed in bed until 9:30 AM. I thought I was having a stroke with sweating, vomiting. I called the ambulance and went to hospital. I am still light headed; not able to drive. A neurologist was called in while in the hospital (3 days).					Y	4			U	10/29/2004	10/30/2004	1		OTH	UNK	Temazepam; Furosemide; Coumadin; Synthroid; Potassium	CHF				1						1	Dizziness; Hyperhidrosis; Vomiting	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0230119	12/07/2004	PA	4.0	3		M	12/02/2004	Pt brought to PCP office on 12/02/04 for c/o local swelling and mild redness at site of immunization with F/U vaccine given 11/30/04. DTaP and IPV given at same visit 11/30/04. Area of swelling approx 5-7cm, no c/o pain, no tenderness, no warmth, no itching.									U	11/30/2004	12/02/2004	2		PVT	PUB	Digoxin 1.2mg ASA, Captopril, carvedilol, Lasix	CHF	CHF, Transposition of great vessels, esotropia, MI			1						1	Injection site erythema; Injection site oedema	DTAP~SANOFI PASTEUR~C1699AA~4~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1515AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X07112~3~IM~RL~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0230120	12/07/2004	MI	78.0	78		M	12/01/2004	A severe cough started five days after my 10/23/2004 flu shot. I also had a severe cough starting three days after a flu shot on 10/20/2003. In both cases, the intermittent cough continues for many weeks.									U	10/20/2004	10/25/2004	5		PUB	UNK			CHF	Severe cough~Influenza (Seasonal) (no brand name)~~77.00~In Patient		1						1	Cough; Vaccine positive rechallenge	FLUX~UNKNOWN MANUFACTURER~U14488AA~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0230163	12/07/2004	NC	29.0	28		F	12/07/2004	Within 7 hours of receiving the Flu Mist, I had a severe headache and fatigue. The next morning when I woke up  my nose, sinuses and throat where sore and completely dried out.  For the next seven days I kept a constant headache, body/muscle aches, dry mouth/throat,nasal passages and a low fever off and on but mostly I was extremely faigued.  I went to see the doctor on Tues. Nov 2nd.  He said he believed I had a bad reaction to the flu mist. My mucous membranes where dried out and my sinuses red and swollen. I had most of these symptoms until 12/4.				Y					Y	11/24/2004	11/24/2004	0		UNK	UNK	none	none	allergic to dust/mold, erythromyacin, rocephin			1						1	Fatigue; Headache; Mucosal inflammation; Myalgia; Pain; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0230171	12/07/2004	LA	1.04	1	.0	M	12/03/2004	On 10/21/04: had synagist fluzone and MMR. On 10/28/04:had temp 104 and seizure x 5 min. Went to ER: final diagnosis from ER was viral syndrome and febrile seizure. On 11/24/04:came to office for more shots and mother  told us had been to ER.				Y					Y	10/21/2004	10/28/2004	7	Lab tests abnormal.	UNK	PUB	Xopenex, Pulmicort		RAD; Medical Record received on 1/12/2005 states prematurity.			1						1	Convulsion; Febrile convulsion; Pyrexia; Viral infection	FLU3~SANOFI PASTEUR~U1415AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1207N~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0230172	12/07/2004	CA	43.0	43		F	11/16/2004	This is a not serious case from a consumer involving sore throat and cough. The reporter causality is not reported. This case qualifies for accelerated reporting. This pt is a 43 year old female who received her first dose of FluMist on 01Nov04. She reports that by the afternoon on 01Nov04 she began feeling weird and light headed, with a low grade fever. the following morning 02Nov04 she felt congested. On 12Nov04 she experienced a low grade fever and lethargy. She reports that from 13Nov04 through 16Nov04 she had a runny nose, sore throat, coughing, throat congestion, as well as the fact that she was sleeping only two to three hours a night due to her symptoms. She started antibiotic therapy on 17No04. She lost her voice for approx 5 days from 11Nov04 until 16Nov04 but now her voice had returned and she is improving overall. No further information is available for this case. Feb 5, 2009 Additional information: Patient date of birth; Product Lot Number; Physician's Information;									Y	11/01/2004	11/01/2004	0		PVT	OTH	Oral Contraceptives		None indicated.		MEDI0002445	1						1	Cough; Dizziness; Feeling abnormal; Insomnia; Laryngitis; Lethargy; Nasal congestion; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500333P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0230177	12/08/2004	NC	41.0	40		F	12/03/2004	Immediately after injection, patient stated her arm hurt and she felt pressure at one side. The next day she had decreased energy ad had waves of nausea but no vomiting. Decreased energy lasted 2 weeks. Pain radiated from elbow to neck x 1 week. Currently complains of pressure at injection site and pain when moving arm. Denies swelling. Mass, arm down to site. Has seen chiropractor and GI specialist since incident . No treatment received. Still with symptoms of pain.									N	11/18/2004	11/18/2004	0		UNK	PVT	Singulair, Ortho Evra, Allegra	Sinus infection	Allergy: Alleve	reaction uneval~Influenza (Seasonal) (no brand name)~1~34.00~In Patient	NC04125	1						1	Fatigue; Injection site reaction; Myalgia; Nausea; Pain; Similar reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~U1527AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230178	12/08/2004	PA	72.0	72		M	12/02/2004	Approximately 48 hours after vaccination was received, I ached all over and was very tired. I developed a severe case of hives that evening 11/21/04. Taking Benadryl relieved the hives. The hives reappeared and disappeared over the next three days, but not as severe as the first onset. Stomach upset occurred on 11/25/04.It was 11/26PM before I started to feel normal. I have had flu shot in many previous years, but never had an adverse effect from the shot.									Y	11/19/2004	11/21/2004	2		PUB	PUB	Cardizem CD, Hyzaar, Zocor, Celebrex					1						1	Dyspepsia; Pain; Urticaria	FLU3~SANOFI PASTEUR~U1532AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230179	12/08/2004	MO	3.0	2	.5	F	12/02/2004	Child received Aventis flu vaccine dose #2 12/01/2004. History of asthma. Developed drooping of her left hip. Report received on 02/22/2005: Age of patient: 2yrs, 6 monts. Vacine:  FIV No other vaccines give with Flu vaccine.  Diagnosis is Bells Palsy, made by the Pediatrician.  Main symptoms are drooping left hip.  The symptoms occurred the next day after vaccine.  There is documentation of Bells Palsy on the other side 10 months before vaccine.									U	12/01/2004	12/01/2004	0	referred to EMT	PVT	PUB	Pulnicort, Ciprodra	Diarrhea	Asthma chronic , OM with BMT, Right Bell's Palsy 3-04 Information from medical records state hx of seizure. msv			1						1	Muscular weakness	FLU3~SANOFI PASTEUR~U1510AA~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230189	12/08/2004	NC	32.0	32		M	12/08/2004	Patient was given Flu Mist vaccine 6 Dec 04. Later that evening he began to have some itching and came to the medical clinic the next morning where he was examined and assessment of urticaria was made.  He was treated with Benadryl. All treatment provided was outpatient.				Y					Y	12/06/2004	12/06/2004	0	None	MIL	MIL		None	Prior hx of allergies as a child to various plants, foods (peanut butter, and others he reports are unknown)			1						1	Pruritus; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500351P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0230191	12/08/2004	IL	76.0	75		F	12/08/2004	Chills & Fever									U	11/29/2004	11/30/2004	1		UNK	UNK						1						1	Chills; Pyrexia	FLU3~SANOFI PASTEUR~U1531AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230195	12/08/2004	OK	56.0	56		F	12/08/2004	PATIENT RECEIVED VACCINE ON 10/7/2004 AND ON 10/21/2004 SHE AWOKE WITH FACIAL PARALYSIS, LATER DIAGNOSED AS BELL'S PALSY. Medical Records received on 1/20/2005 states pt experienced ptosis, pain, headache, hypertension and conjunctivitis.									N	10/07/2004	10/21/2004	14	Medical Records received on 1/20/2005 states EKG abnormal.	MIL	MIL			Medical Records received on 1/20/2005 states hypothyroid, diabetes mellitus, and hypercholesteremia.			1						1	Conjunctivitis; Electrocardiogram abnormal; Eyelid ptosis; Facial palsy; Headache; Hypertension; Pain	FLU3~SANOFI PASTEUR~U1442AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230196	12/08/2004	KS	68.0	68		F	12/08/2004	11/24 c/o weakness, muscle fatigue, the muscles in her thighs and above her elbows especially. When she exerts her muscles she feels stronger than when she is relaxed. She feels like her muscles are going to sleep. Went to the ER 11/25/04. EKG and blood tests were OK. A chest x-ray revealed a patch that could be pnuemonia. She has had a cold and has had a little cough since September. They Rxed a Z-pack. She saw her Dr. 11/30 because of the continued muscle weakness. A CAT scan of her chest and blood work were normal. She is scheduled for pulmonary tests and a stress test on 12/13/04.				Y					U	11/16/2004	11/24/2004	8		UNK	UNK	ASA, lipitor	None	Bypass '99,carotid artery surgery '90,gallbladder surgury 2 years ago. 2 lumbar discs in her lower back are touching. Neck problems from a car accident.			1						1	Asthenia; Fatigue; Muscular weakness; Pneumonia	FLU3~SANOFI PASTEUR~U1558AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0230197	12/08/2004	NJ	48.0	48		F	12/08/2004	Received FluMist vaccine on Monday, 11/29/04 at approximately 1:00 p.m.  No prior allegry to eggs or the regular flu shot vaccine I received in 2003, 2002, and 2001 without any problems.  Started to develop hives over entire body by about 7:00 p.m. on 11/29/04.  Called doctor on Tuesday afternoon (11/30/04) around 3:00 p.m.  Was told to take Benadryl for hives on body and face.  Called Registered Nurse Phone Line on Tuesday evening (11/30/04) around 11:00 p.m. Called my rheumatologist on Tuesday (11/30/04) about 11:30 p.m.  I was prescribed 20 mg of prednisone with Benadryl to be taken at that time.  On Wednesday (12/1/04) the hives had not diminished at all over entire body and face.  Around 5:30 p.m. called the Registered Nurse Phone Line.  Around 6:00 p.m. called doctor, who prescribed another 20 mg prednisone to be taken with Benadryl at that time.  Benadryl had no effect.  Thursday morning (12/2/04) around 1:00 a.m. had low-grade temperature of 99.2, with sweating alternating with chills, and mild intestinal discomfort.  Saw doctor on Thursday morning (12/2/04) in her office at about 11:00 a.m.  Hives and white-edged ring shaped red spots still covered body and face.  She said the activity on my skin was hives and flu virus. Doctor prescribed a decreasing dose of prednisone, starting with 40 mg, along with Allegra 180 once a day, and topical Lidex.  Lidex had no effect. Thursday (12/2/04) hives were suppressed by prednisone and Allegra 180 for about 10 hours.  Friday (12/3/04) hives were suppressed by prednisone and Allegra 180 for about 14 hours.  Hives and red spots have been suppressed by prednisone and Allegra 180 since Saturday (12/4/04).  As of Wednesday (12/8/04), have two more days of .05 mg of prednisone with one Allegra 180 daily.  Scheduled to take Allegra 180 through Sunday (12/13/04).				Y					Y	11/29/2004	11/29/2004	0		UNK	UNK	Achiphex - 20 mg twice daily; hydrochlorathiazide - 50 mg once daily; Ambien - 10 mg once nightly; topical progesterone cream (Emerita); Dovonex as needed for psoriasis	None	gutate psoriasis; psoriatic and osteo-arthritis; gastric hernia; allergies to gluten and dairy			1						1	Abdominal pain; Chills; Hyperhidrosis; Pyrexia; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0230200	12/08/2004	MI	0.5	0	.5	F	12/07/2004	Feet and hands blue, pt listless, sleeping, seen by Dr at clinic, monitored and discharged with no treatment. Resolved on own. *Should this infant be tested for egg allergy*									U	12/02/2004	12/03/2004	1	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Cyanosis; Listless; Somnolence	FLU3~SANOFI PASTEUR~U1560AB~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230201	12/08/2004	CA	0.46	0	.5	M	12/08/2004	Pt came in to office day after immunizations with redness, Sl swelling, feverish and tender discoloration above inj site and up to armpit. Pt temp 102.8, inconsolable crying. Bruised looking along left side and across buttocks. From discharge summary states group B strep, from medical records cough. msv					Y	7			Y	12/01/2004	12/02/2004	1	Blood culture	PVT	PVT	Elidil and Rondec DM	URI, ASD	ASD From discharge summary, obesity, from medical records prematurity. msv			1						1	Bacterial infection; Contusion; Cough; Crying; Injection site erythema; Pyrexia; Screaming; Skin discolouration; Swelling; Tenderness	DTAP~SANOFI PASTEUR~C2103AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1449AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~U9858AA~3~IM~RL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~X1038~3~SC~LA~POLIO VIRUS, INACT. (IPOL)~1	USA	Hospitalisation	Influenza
0230202	12/08/2004	FL	80.0	80		M	12/08/2004	Right frontal headache, numbness, weakness, vocal cord paralysis, Guillain-Barre Syndrome. IVIG started 12/4/04.   12/09/04 Spoke with reporter. Patient is a retired MD and hospital volunteer. He received Fluzone, lot U1527AA on 11/15/04 at the hospital. He was well at the time and within the month prior to the best of reporter's knowledge. He receives flu vaccine each year and has not experienced an AE previously. There is no known history of prior GBS or related illness. Initially it was thought that this gentleman was suffering from sinusitis due to his c/o frontal HA. He was treated with Biaxin, but got progressively worse and by 12/2/04 he was admitted to hospital with nausea, facial numbness, and an episode of falling. He has been treated with IVIG and Acyclovir and diagnosed with a variant of GBS. Yesterday he was transferred to ICU and prognosis is guarded. Pt has been up to bedside commode and appears oriented with clear speech, but hoarseness.  Medical records received on 12/15/2004 states pt remains in hospital at time of follow-up. Diagnosis of GBS confirmed. Pt experienced the following symptoms: right-sided earache and eye ache, hoarseness, sore throat & upper airway congestion, anorexia, and hypoglycemia. On PE symptoms were noted of dehydration, slurred speech, dysphagia, increasing cough, sinus tachycardia, and rhonchi. Follow Up: Admitted to hospital 12/2/04. Transferred from floor to ICU on 12/8/04. Initially treated for suspected sinusitis (Biaxin). Progressively worsened: nausea, falling, facial paralysis. Treated with Acyclovir and IVIG. Currently oriented with clear speech and hoarseness. Follow up 02/22/05: Recovery status unknown.					Y				U	11/15/2004	11/21/2004	6	Medical Record received on 12/15/2004 states CSF protein elevated, sodium decreased, and glucose elevated.	PUB	PUB	Insulin; Vasotec; Dyazide; Lipitor	NONE	Diabetes Type II; Hypertension; Degenerative Joint Disease  Past surgical history of TUR (2002), cervical laminectomy and bone graft (2002), bilateral cataract surgery (1980), cholecystectomy (1979), appendectomy (1982), shoulder arthroscopy (1997). PMH of pancreatitis and hepatitis (1953). Additional preexisting medical conditions at the time of flu vaccination include peripheral neuropathy, retinopathy secondary to DM, and urinary retention secondary to TUR or pain medication.			1						1	Anorexia; Asthenia; CSF test abnormal; Cough; Dehydration; Dysarthria; Dysphagia; Dysphonia; Ear pain; Eye pain; Facial palsy; Fall; Guillain-Barre syndrome; Headache; Hyperglycaemia; Hypoaesthesia; Hypoglycaemia; Hyponatraemia; Lung disorder; Nasal congestion; Nausea; Pharyngolaryngeal pain; Sinus tachycardia; Sinusitis; Vocal cord paralysis	FLU3~SANOFI PASTEUR~U1527AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0230203	12/08/2004	TX		4		M	12/08/2004	Cellulitis 4cmx8cm on left thigh, placed on Bactrim 2 teaspoons twice a day				Y					Y	12/06/2004	12/06/2004	0		PVT	OTH		Rash on left thigh	Asthma			1						1	Cellulitis	DTAP~SANOFI PASTEUR~C2044AA~5~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1937AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1212~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0345P~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0230204	12/08/2004	NJ	41.0	40		F	12/07/2004	Dizzy, diaphoretic, weak, nausea, felt above symptoms immediately on a lifted head off pillow in AM to get out of bed, felt fine if laid perfectly still. Symptoms started to subside in early afternoon. Felt fine about 4:30PM									Y	12/02/2004	12/03/2004	1		PUB	UNK	Singular, Prevacid, Rhinocort		PCN, Peanuts, diag. dye, asthma controlled.	~Measles + Mumps + Rubella (no brand name)~~27.00~In Patient		1						1	Asthenia; Dizziness; Hyperhidrosis; Nausea	FLU3~SANOFI PASTEUR~U1454AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0198551	12/09/2004		19.0			M	10/08/2004	A report was received from another manufacturer on 12/19/03 concerning a 19 year old male vaccinee who experienced acute disseminated encephalomyelitis and urinary retention 20 days after receiving influenza vaccine, yellow fever, anthrax vaccine, typhoid vaccine, polio vaccine, hepatitis A vaccine, hepatitis B vaccine, MMR, and possibly varicella vaccine on 2/2/03. The vaccinee also received a second anthrax vaccination on 2/2/03. All vaccines were brand unspecified. On 2/22/03, the vaccinee was hospitalized with complaints of fever of 100.4 F, sore throat, headache for five days, numbness from the knees down, weakness and difficulty walking. He also had pressure on the genitalia and urge to urinate. The vaccinee was diagnosed with acute disseminated encephalomyelitis and urinary retention. He was treated with high dose steroids and physical therapy. The vaccinee was discharged to another hospital on 3/1/03. His condition regressed to inability to walk, decrease in sensation, and inability to void after being off steroids for about three to five days. The vaccinee was given another course of high dose steroids for five days and IV immunoglobulins for two days. The vaccinee improved. He was prescribed oral steroids for three weeks. He was discharged from hospital on 3/19/03 with discharge diagnosis of unspecified infectious and parasitic diseases, retention of urine, and post-infectious encephalitis. On 3/21/03 the vaccinee stated that he still had some numbness in his feet, but is otherwise greatly improved. He also stated that he had been ill with an upper respiratory infection about mid-February and was taking amoxicillin, pseudoephedrine hydrochloride, ibuprofen, and paracetamol on 2/20/03 at the time of the anthrax vaccination. Within one to two days afterwards, the symptoms of encephalomyelitis were noted and he was admitted to a local hospital until being transmitted to a second hospital on 3/1/03. Additional information received on 12/9/03 from the yellow fever vaccine testing group indicated that the vaccinee had clinical, radiological and laboratory evidence of acute disseminated encephalomyelitis, with immunoglobulin M in cerebrospinal fluid of 9.8. This cause was reported to be a possible yellow fever vaccine associated neurotropic disease with autoimmune involvement. A lumbar puncture was carried out on 2/23/03. CSF results were: glucose 77, protein 73, WBC 159, RBC 4, mononucleosis 90%. Lyme screen was negative. Blood and urine cultures were negative. A throat culture was negative for streptococcus group A. Testing was carried out at the CDC from a cerebrospinal fluid sample and a serum sample both collected on 3/6/03. The results from the CSF indicated good immunoglobulin M response by MAC-ELISA, negative to West Nile virus, St. Louis, and Powassan, negative virus culture on Vero cells. TagMan polymerase chain reaction for yellow fever was not done and neutralization antibody assay was not done as there is no standard for this. The results from the serum indicated good immunoglobulin response by MAC-ELISA, negative to West Nile virus, St. Louis, and Powassan, plaque-reduction neutralization test to yellow fever virus was positive at a 1:320 titer, negative virus culture on Vero cells, and negative TagMan polymerase chain reaction for yellow fever. The outcome of the events were not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.					Y				U	02/02/2003	02/22/2003	20	Additional information received on 12/9/03 from the yellow fever vaccine testing group indicated that the vaccinee had clinical, radiological and laboratory evidence of acute disseminated encephalomyelitis, with immunoglobulin M in cerebrospinal fluid of 9.8. This cause was reported to be a possible yellow fever vaccine associated neurotropic disease with autoimmune involvement. A lumbar puncture was carried out on 2/23/03. CSF results were: glucose 77, protein 73, WBC 159, RBC 4, mononucleosis 90%. Lyme screen was negative. Blood and urine cultures were negative. A throat culture was negative for streptococcus group A. Testing was carried out at the CDC from a cerebrospinal fluid sample and a serum sample both collected on 3/6/03. The resutls from the CSF indicated good immunoglobulin M response by MAC-ELISA, negative to West Nile virus, St. Louis, and Powassan, negative virus culture on Vero cells. TagMan polymerase chain reaction for yellow fever was not done and neutralization antibody assay was not done as there is no standard for this. The results from the serum indicated good immunoglobulin response by MAC-ELISA, negative to West Nile virus, St. Louis, and Powassan, plaque-reduction neutralization test to yellow fever virus was positive at a 1:320 titer, negative virus culture on Vero cells, and negative TagMan polymerase chain reaction for yellow fever.	UNK	UNK	NONE		NONE		PJP200400055	1						4	Abasia; Asthenia; Depressed level of consciousness; Difficulty in walking; Encephalitis; Headache; Hypoaesthesia; Laboratory test abnormal; Pharyngolaryngeal pain; Pyrexia; Urinary retention	ANTH~EMERGENT BIOSOLUTIONS~~UNK~~~ANTHRAX (BIOTHRAX)~4|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~4|HEPA~MERCK & CO. INC.~~UNK~~~HEP A (VAQTA)~4|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~4|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~4|YF~UNKNOWN MANUFACTURER~~UNK~~~YELLOW FEVER (NO BRAND NAME)~4	USA	Hospitalisation	Influenza
0210130	12/09/2004		22.0	21		F	10/08/2004	A report was received from a healthcare professional on 10/07/2003 concerning a 21 year old female vaccinee who developed a swollen, aching arm, flu-like symptoms including body aches and a sore throat on 10/03/2003 after receiving Fluvirin vaccine on 10/03/2003. The vaccinee's arm became swollen and ached following vaccination.  That evening the vaccinee experienced flu-like symptoms including body aches and a sore throat.  The doctor who administered the vaccine and a co-worker were also given the same vaccination and both experienced the same symptoms.  The vaccinee had recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment.									Y	10/03/2003	10/03/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300767	1						2	Influenza like illness; Pain; Pharyngolaryngeal pain; Swelling	FLU3~EVANS VACCINES~765412~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0210132	12/09/2004		37.0	36		F	10/08/2004	A report was received from a healthcare professional on 10/07/2003 concerning a 36 year old female vaccinee who developed a swollen, aching arm, flu-like symptoms including body aches and a sore throat on 10/03/2003 after receiving Fluvirin vaccine on 10/03/2003. The vaccinee's arm became swollen and ached following vaccination.  That evening the vaccinee experienced flu-like symptoms including body aches and a sore throat.  The co-worker who administered the vaccine and a second co-worker were also given the same vaccination and both experienced the same symptoms.  The vaccinee had recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									Y	10/03/2003	10/03/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300769	1						2	Influenza like illness; Pain; Pharyngolaryngeal pain; Swelling	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0211092	12/09/2004		35.0	34		F	10/08/2004	A report was received from a health care professional on 11Dec03 concerning a 34 year old female vaccinee who experienced hypersensitivity with a feeling of itching in the throat and tightening, redness and a feeling of itching all over her body and difficulty breathing, which was considered medically significant, on 15Oct03 at 21:25 hours after receiving Fluvirin vaccine on 15Oct03 at 21:00 hours. The vaccinee has a history of several environmental allergies and comedications included cetirizine hydrochloride, citalogram and another drug to be confirmed. On 15Oct03 at 21:25 hours the vaccinee experienced a feeling of itching in the throat and tightening and took 50mg oral diphenhydramine hydrochloride. By 22:00 hours the attending physician referred the vaccinee to the ER for additional treatment as the vaccinees entire body had become red and itchy. The vaccinee received additional treatment with IV diphenhydramine hydrochloride and IV methylprednisolone sodium succinate in the ER and was discharged home on 16Oct03 at approximately 00:30 hours on 40mg oral prednisolone sodium phosphate for 15 days, 20mg cetirizine hydrochloride and 200mg oral diphenhydramine hydrochloride daily. The vaccinee was seen by a physician on the 16Oct03 and due to continued, itching and difficulty breathing was given 125mg IM methylprednisolone sodium succinate. The outcome was not reported at the time of this report. There was insufficient information to determine the reporters causality assessment. Follow up pending. Follow up received 18Jun04: follow up information received from an occupational health nurse on 18Jun04. The vaccinee was diagnosed as having an anaphylactic reaction to flu vaccine. Her symptoms included itchiness and swollen tongue. The symptoms started on 15Oct03 following vaccination and resolved on 16Oct03 (swollen tongue) and on 17Oct03 (itchiness). She had received flu vaccine for the previous two years without reaction. Her last influenza vaccination was given on 20Oct02. The anaphylactic reaction was treated with 125mg SoluMedrol, 50mg Benadryl and 40mg Prednisone for 5 days. Her concomitant medications included Zyrtec 10mg, Albuterol Inhaler, Esgic and Benadryl. Her past medications included Keflex and Vicodin. The reporter considers the event serious as medical intervention was required. The reporter has submitted a report on this case.									U	10/15/2003	10/15/2003	0		UNK	UNK	Zyrtec 10mg, Lexapro, Albuterol Inhaler, Esgic 500-40-5 (Tabs)		Several allergies (environmental, animals) for which she takes Zyrtec. Had received flu vaccine previous 2 years without reaction. Intolerance to beef and milk.		PJP200301298	1						2	Anaphylactic reaction; Dyspnoea; Erythema; Injection site hypersensitivity; Pruritus; Throat tightness	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0211671	12/09/2004		49.0	49		F	10/08/2004	A report was received from a healthcare professional on 10/23/2003, concerning a 49 year old female vaccinee who experienced hives, itching, diarrhea, red spots and red patches the evening after receiving the Fluvirin vaccinee on 10/23/2003. On the evening of 10/22/2003, the vaccinee experienced itching over her entire body and hives were visible on her right shoulder and back.  The vaccinee did not experience fever but had 9 episodes of diarrhea over a 6 hour period.  Diphenhydramine was administered three times during a 4 and a half hour period.  On 10/23/2003 the vaccinee woke up with 'red spots' and patches on her back and right shoulder.   There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/22/2003	10/22/2003	0		UNK	UNK	Concomitant drug not reported. Diphenhydramine administered on 10/22/2003.		Allergies to prochlorperazine, Ketorolac, Doxycycline, Green peppers.  Had received Fluvirin for the last 6 years with no reaction.		PJP200300887	1						2	Diarrhoea; Erythema; Pruritus; Urticaria	FLU3~EVANS VACCINES~765707~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0212063	12/09/2004		47.0	46		F	10/08/2004	A report was received from a consumer on 30 October 2003 who was a 46 year old female vaccinee who experienced itching 6 hours after vaccination and burning 2 days after vaccination with Fluvirin on 28 October 2003. Approximately 6 hours after vaccination the vaccinee experienced itching in her arms and legs which spread to her hands and feet.  The vaccinee was self-treating with diphenhydramine hydrochloride but was unable to take it around the clock for complete relief.  On 30 October 2003, at 3:00AM, the vaccinee experienced intense itching and burning of her hands and soles of her feet.  The vaccinee was using terbinafine hydrochloride on her feet.  It was the vaccinee's first influenza vaccine.  The vaccinee planned to discuss her symptoms with her physician. Follow up pending.									U	10/28/2003	10/28/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300953	1						2	Pruritus; Skin burning sensation	FLU3~EVANS VACCINES~765795~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0212109	12/09/2004		31.0	30		F	10/08/2004	A report was received from a healthcare professional on 04 November 2003 concerning a 30 year old female vaccinee who experienced chest tightness and difficulty in breathing which was considered to be medically significant 15 to 20 minutes after receiving Fluvirin vaccine on 04 November 2003. On 04 November 2003 the vaccinee developed chest tightness and difficulty in breathing within 15 to 20 minutes of receiving Fluvirin.  The vaccinee was administered one dose of diphenhydramine hydrochloride and her symptoms resolved on 04 November 2003. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/04/2003	11/04/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300978	1						2	Chest discomfort; Dyspnoea	FLU3~EVANS VACCINES~765954~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0212546	12/09/2004		58.0			F	10/08/2004	A report was received from a health care professional on 11/07/03, concerning a 58 year old female vaccinee who developed a hard knot at the site of injection and skin discoloration around injection site 4 to 5 hours later, also pain later that night. A swollen and red arm with ecchymosis a day after receiving Fluvirin on 10/20/03. On 10/20/03, the vaccinee developed a hard knot at the site of injection. The skin around the injection site appeared red/blue in color. Later that night, the vaccinee experienced pain and could not move her arm. On the morning of 10/21/03 the red/blue color spread from the injection site down her elbow. The vaccinee's are was severely swollen and red. On 10/24/2003, the vaccinee was seen by the reporter for dialysis who described the condition as a red blue ecchymosis, which covered the entire upper arm. The vaccinee was seen in the emergency room and instructed to apply warm pads to the affected area and was prescribed hydrocodone acetaminophen for the pain. At the time of the report, the vaccinee's are was less swollen and painful but the red/blue color remained and there was no change in the size of the ecchymosis. There was insufficient information to determine the reporter's causality assessment. Follow up pending.				Y					N	10/20/2003	10/20/2003	0		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported. End stage renal disease		PJP200301030	1						2	Injection site erythema; Injection site haemorrhage; Injection site induration; Injection site reaction; Pain; Skin discolouration; Swelling	FLU3~EVANS VACCINES~765799~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0217809	12/09/2004		56.0	56		M	10/08/2004	A report was received from a non-health care professional on behalf of the vaccinee who is a physician on 11/21/03 concerning a 56 year old male vaccinee who experienced weakness in his arms and legs which progressed to weakness all over his body, and was diagnosed with Guillain Barre Syndrome, which was considered to be medically significant (OMIC), approximately 2 weeks after receiving Fluvirin vaccine on 10/16/03. Approximately 2 weeks after receiving Fluvirin the vaccinee complained of weakness in his arms, which progressed to his legs and currently the vaccinee complains of feeling weak all over his body. The weakness in his hands has improved. The vaccinee sought medical attention and was subsequently diagnosed with Guillain Barre Syndrome. Treatment for the event included IV immunoglobulin (5 doses). The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 12/16/03: Further information received from a health care professional, who is the vaccinee, indicated that he experienced Guillain Barre Syndrome with a typical clinical presentation from 11/6/03, which was considered disabling and resulted in hospitalization on 11/21/03. CSF laboratory findings were confirmatory. An MRI of the cervical and thoracic spine was negative. The vaccinee was treated with IV immunoglobulin for 5 days. The vaccinee was discharged from hospital on 11/23/03. The vaccinee had not recovered at the time of the report. The vaccinee has a relevant medical history of hypertension and co-medications included Ramipril, Esomeprazole, Azithromycin from 10/20/03 to 10/24/03 for bronchitis and levofloxacin from 10/25/03 to 11/5/03 for bronchitis. The vaccinee had previous exposure to Fluvirin and did not experience similar events. The reporter as assessed the relationship of the vaccine to the Guillain Barre Syndrome as probable. Update 1/21/04: Further information was received from a health care professional on 1/21/04 indicating that the vaccinee experienced Guillain Barre Syndrome on 11/7/03 with classic clinical presentation. The vaccinee was treated with IV immunoglobulin from 11/14/03 to 11/18/03 and gabepentin from 12/03 and ongoing. The vaccinee had no previous episodes of Guillain Barre Syndrome. The vaccinee continues to have generalized muscle weakness, paresthesia and numbness. The vaccinee was treated with uvulopharyngopalato-plasty for sleep apnea in April 2003 and cefalexin monohydrate, azithromycin and doxycycline for an upper respiratory infection in October 2003. Follow up pending.					Y	2		Y	U	10/16/2003	10/29/2003	13	CSF laboratory findings were confirmatory for GBS. An MRI of the cervical and thoracic spine was negative.	UNK	UNK	Altace, Nexium, Zithromax, Levofloxacin		Hypertension, bronchitis, sleep apnea, and URI.		PJP200301152	1						2	Asthenia; Back pain; CSF test abnormal; Dysphonia; Guillain-Barre syndrome; Hypoaesthesia; Hypotension; Muscle atrophy; Guillain-Barre syndrome; Hypoaesthesia; Muscular weakness; Paraesthesia	FLU3~EVANS VACCINES~765484~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~EVANS VACCINES~765484~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Hospitalisation,Disabling	Influenza
0227061	12/09/2004		59.0			F	10/08/2004	A report was received from another pharmaceutical company on 15Jan04 concerning a 59 year old female vaccinee who experienced redness and pain at the injection site and a 2x 2 1/2 necrotic area at the injection site on 18Nov02, which was considered medically significant and required surgical intervention, after receiving influenza vaccine (brand unspecified) and Pneumovax 23 on 13Nov02 at 13:30 hours. The vaccinee has a medical history of allergy (comatose) to codeine. On 13No02 the vaccinee was administered influenza vaccine (brand unspecified) and pneumococcal 23v polysaccharide vaccine in the same site. The vaccinee experienced redness and pain at the injection site an unspecified length of time following vaccination. Unspecified medical attention was sought. On 18Nov02 the vaccinee had developed a 2x 2 1/2 necrotic area at the injection site, which was surgically removed 2 weeks later. The outcome of the events was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/13/2002	11/18/2002	5		UNK	UNK	NONE		Allergy to codeine		PJP200400093	1						2	Injection site erythema; Injection site necrosis; Injection site pain; Injection site erythema; Injection site necrosis; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0445M~UNK~IM~~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0449M~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0228470	12/09/2004	FL	7.0	7		M		This is a non serious case from a medical assistant in the USA who reports a patient experienced a red, raised rash after receiving FluMist. This case is submitted according to the safety surveillance accelerated reporting agreement for FluMist. The reporter did not provide causality between events and FluMist. Within 48 hours of receiving FluMist on 10/26/04, a 7 year old male experienced a red, raised rash and itching. He was treated with Benadryl and recovered after four or five days. 10Feb05 additional informatin received: Pt's date of birth, exact onset time and time of Flumist administration was not recorded.									Y	10/26/2004	10/26/2004	0		PVT	PVT	NONE		The patient had one sister that received FluMist with no adverse events.		MEDI0002478	1						2	Cough; Erythema multiforme; Pyrexia; Rhinorrhoea; Urticaria; Pruritus; Rash erythematous	FLUN3~MEDIMMUNE VACCINES, INC.~500336P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500336P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0230216	12/09/2004		34.0	33		M	10/08/2004	A report was received from a health care professional on 01Oct03 concerning a male vaccinee of unk age who developed arthritis and joint pain on his ankle an unspecified length of time after receiving Fluvirin vaccine on an unk date. On an unk date the vaccinee received a dose of Fluvirin vaccine and developed arthritis and joint pain on his ankle. The vaccinees symptoms had been resolving gradually at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up information received from a health care professional indicated that the vaccinee experienced inflammation of the right ankle joint on 30Sep03 following vaccination the previous day. Uric acid crystals were seen in the fluid but serum uric acid was 5.4. The vaccinees symptoms resolved in a week following treatment with NSAIDS. The reporter has assessed the relationship of the vaccine to the event as possible. All information received, no follow up pending.									U	09/29/2003	09/30/2003	1		UNK	UNK	NONE		NONE		PJP200300738	1						1	Arthralgia; Arthritis; Blood uric acid increased	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230217	12/09/2004					U	10/08/2004	A report was received from a health care professional on 21 October 2003 concerning a vaccinee of unknown demography who experienced confusion and encephalopathy and was hospitalized an unspecified length of time after receiving Fluvirin on an unspecified date. On an unspecified date the vaccinee experienced confusion and encephalopathy. The vaccinee was admitted to hospital on an unspecified date. The outcome of the events were not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.					Y				U					UNK	UNK					PJP200300845	1						1	Confusional state; Encephalopathy	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0230218	12/09/2004		33.0	33		M	10/08/2004	A report was received from a health care professional on 07 November 2003 concerning a 33 year old male vaccinee who experienced sweating, shortness of breath, flushing, and later developed redness and swelling at the injection site, which was considered to be medically significant, on 06 November 2003 after receiving Fluvirin vaccine on the same day. On 06 November 2003 the vaccinee immediately experienced sweating, shortness of breath and flushing after vaccination and was admitted to the local emergency department where the attending physician informed the nursing staff that the vaccinee had a localized reaction. Later during the hospital visit, the vaccinee developed redness and swelling at the injection site. The vaccinee's symptoms resolved on the same day and he was discharged from the hospital. There was insufficient information to determine the reporter's causality assessment. Update 1, 12 December 2003: Further information was received from a health care professional indicating that the vaccinee experienced itching and swelling of his right arm, a sensation of throat swelling but no physical evidence of the neck or throat , with difficulty speaking, dizziness, cold chills and sweats within 20 minutes of receiving Fluvirin on 06 November 2003. The vaccinee's symptoms resolved on the same day. The vaccinee has a medical history of non-insulin dependent diabetes mellitus. Medications included fenofibrate, rosiglitance maleate, clomifene citrate and multivitamins. It was noted that the vaccinee became anxious  and nervous prior to Fluvirin administration and kept clearing his throat. The ER report confirmed that the vaccinee experienced a local reaction to a flu vaccine.. The vaccinee was treated with hydroxyzine embonate and triamcinolone acetonide. The vaccine had previously received flu vaccine several years ago and had soreness of the arm but no noticeable reaction. Update 2, 02 April 2004: Further information was received from a health care professional indicating that the vaccinee experienced an allergic reaction to the Flu vaccine with symptoms of nausea, extreme pain in his right arm and neck pain on 06 November 2003. The vaccinee was also treated with hydroxyzine hydrochloride 25mg as required. On 06 November 2003 at 15:35, the vaccinee's blood pressure was 151/92mmHg, pulse rate was 72 bpm and respiratory rate was 20/min. The vaccinee was discharged at 17:04 and advised to return to the emergency room if he experienced any further problems. The vaccinee has a further medical history of heart murmur and high cholesterol. The vaccinee had no known allergies and no swelling of larynx was seen. No follow up pending, no further information available.									Y	11/06/2003	11/06/2003	0	Blood pressure 151/92 mmHg; Pulse rate 72 bpm; respiratory rate 20/min.	UNK	UNK	Tricor, Avandia, Clomid, and Foutx		Non-insulin dependent diabetes mellitus, high cholesterol and heart murmur.	Soreness in arm~Influenza (Seasonal) (no brand name)~1~0.00~In Patient	PJP200301032	1						1	Chills; Dizziness; Dyspnoea; Flushing; Heart rate increased; Hyperhidrosis; Hypersensitivity; Hypertension; Injection site erythema; Injection site reaction; Injection site swelling; Nausea; Pain; Pruritus; Respiratory rate increased; Speech disorder; Vaccine positive rechallenge	FLU3~EVANS VACCINES~765955~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230219	12/09/2004		49.0	49		F	10/08/2004	A report was received from a health care professional on 19 November 2003, concerning a 49 year old female vaccinee who experienced angioedema which was considered to be medically significant (OMIC) the day after inadvertently receiving Fluvirin intradermally on 14 November 2003. The vaccinee had an allergy to co-trimoxazole and has no concomitant medications. On 15 November 2003 the vaccinee experienced angioedema with generalized urticaria and swelling of the lips and tongue after inadvertently receiving Fluvirin intradermally. The vaccinee was treated with diphenhydramine. At the time of the report the angioedema was improved nut continuing. There was insufficient information to determine the reporter's causality assessment. Follow-up pending. See ref: PJP-2003-01116.									U	11/14/2003	11/14/2003	0		UNK	UNK			Allergy to co-trimoxazole.		PJP200301115	1						1	Angioneurotic oedema; Face oedema; Medication error; Tongue oedema; Urticaria	FLU3~EVANS VACCINES~765496~UNK~ID~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230220	12/09/2004		55.0	54		M	10/08/2004	A report was received from health care professional on 19 November 2003, concerning a 54 year old male vaccinee who experienced angioedema which was considered to be medically significant (OMIC) the day after inadvertently receiving Fluvirin intradermally on 14 November 2003. On 15 November 2003 the vaccinee experienced angioedema with generalized blotchy edema and pruritus after inadvertently receiving Fluvirin intradermally. The vaccinee was treated with cetirizine hydrochloride. At the time of the report the angioedema was improved but continuing. There was insufficient information to determine the reporter's causality assessment. Follow-up pending. See ref: PJP-2003-0115.									U	11/14/2003	11/15/2003	1		UNK	UNK			Allergy to PCN.		PJP200301116	1						1	Angioneurotic oedema; Medication error; Oedema; Pruritus; Rash macular	FLU3~EVANS VACCINES~765496~UNK~ID~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230222	12/09/2004		69.0			M	10/08/2004	A report was received from a health care professional on 25 November 2003 concerning a 69 year old male vaccinee who experienced Guillain-Barre Syndrome, requiring hospitalization an unspecified length of time after receiving Fluvirin on an unspecified date. On unspecified date the vaccinee experienced GBS. The vaccinee was hospitalized on an unspecified date. The outcome of the event was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.					Y				U					UNK	UNK					PJP200301173	1						1	Guillain-Barre syndrome	FLU3~EVANS VACCINES~765412~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0230224	12/09/2004		30.0			M	10/08/2004	A report was received from a health care professional on 6 January 2003, concerning a male vaccine of approximately 30 years of age who experienced Guillain-Barre Syndrome, and was hospitalized approximately 2-3 weeks after receiving Fluvirin on 20 November 2003. On an unspecified date in 2003, 2-3 weeks after receiving Fluvirin the vaccinee experienced symptoms of GBS. The vaccinee was hospitalized on an unspecified date. The vaccinee experienced symptoms of GBS primarily in the lower extremities. The symptoms had not resolved at the time of the report. The vaccinee had received influenza vaccine (brand unspecified) in the past without any adverse events occurring. There was insufficient information to determine the reporter's causality assessment. Follow up pending.					Y				U	11/20/2003	12/10/2003	20		UNK	UNK					PJP200400025	1						1	Guillain-Barre syndrome	FLU3~EVANS VACCINES~765485~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0230225	12/09/2004		54.0			M	10/08/2004	A report was received from a pharmaceutical company who received the report through an enhanced surveillance program conducted by the CDC on 1/5/04 concerning a 54 year old male vaccinee who experienced myocardial infarction on 10/03/03 and heartburn on 10/2/03, which was considered life threatening, required medical intervention and resulted in hospitalization on 10/3/03, after receiving influenza vaccine, Yellow Fever vaccine, Meningococcal vaccine, Smallpox vaccine, hepatitis B vaccine and Hepatitis A on 2/15/03 and Anthrax on 2/3/03, 2/15/03 and 3/5/03. The vaccinee has a medical history of hyperlipidemia, degenerative joint disease and shortness of breath after exercise (baseline for vaccinee). The vaccinee denied any past history of hypertension, angina, congestive heart failure, cerebrovascular accident, valvular heart disease, diabetes, asthma, cancer or thyroid disease. Concomitant medications included Ramipril, Acetylsalicylic acid, Isosorbide mononitrate, Atorvastatin, Metoprolol tartrate and Clipidogrel sulfate (to be clarified). On 10/2/03, the vaccinee experienced heartburn while resting, which he described the sensation as a burning feeling in the middle of his chest and rated it as a six out of ten on a pain scale and he felt a strong urge to burp, but he was unable to do so. The vaccinee was admitted to hospital and seen in the emergency room where he was subsequently diagnosed with a myocardial infarction on 10/3/03. The vaccinees medical records stated that he had experienced intermittent chest pain/pressure at rest for two to three weeks. The vaccinee had elevated cardiac enzymes and an initial ECG revealed ST elevation in lead III and subsequent T wave inversion in leads II, III, and AVF. The vaccinee underwent a cardiac catheterization with stent placement. Mild posterior wall hypokinesis was revealed. The left heart catheterization and left ventriculogram and coronary angiogram revealed severe two-vessel coronary artery disease with the right coronary artery being the cause of the vaccinees recent non-Q myocardial infarction. The vaccinees left anterior descending artery was of a very small caliber, which was not optimal for surgical intervention. He had normal left ventricular systolic function. Gated spectrophotometric images of the heart were obtained following the vaccinees recovery, which revealed that the left ventricular ejection fraction was 66% and wall motion was good. The impression from the Cardiolite Scan was abnormal myocardial perfusion with ischemia in the inferolateral wall region. The vaccinee was discharged from hospital and stated that he did not experience any further chest pain or heartburn type symptoms. The vaccinee was scheduled for another stress test on 11/15/03. the outcome of the event was unknown at the time of the report. A radiological examination was performed on 9/22/03, which showed that the vaccinees lungs were mildly hyper-inflated, but clear of infiltrate. The heart and pulmonary vessels appeared to be of a normal size. The impression was a non-specific hyperinflation and focal degenerative changes of the left distal clavicle of the AC joint. Laboratory tests on 10/3/03 at 08:15 revealed the following: CK-MB high at 11.1u/l, relative index high at 4.8, MB confirmation high at 11.85ng/ml, and CK 231u/l. At 14:54 on 10/3/03, CK-MB Screen relative index 5.2, MB confirmation 19.36ng/ml, CK 330u/l, Troponin I 15.42 ng/ml, monocyte high at 1.2 k/ul, WBC high at 11.2 k/ul, cholesterol high at 255 mg/dl, triglyceride high at 192 mg/dl, LDL-cholesterol high at 199 mg/dl. Bacteriology results were <10,000 CPU/ml, urine was contaminated and 3 or more organisms were isolated. On 10/4/03 at 07:16, Troponin I was critically high at 5.87 ng/ml, CK was 146 u/l, calcium low at 8.9 mg/dl, anion gap low at 9 mmol/l. On 10/5/03, parasitology results were negative for occult blood. On 10/9/03, a chest x-ray revealed mild prominence of infrahilar markings, MCH was 31.8. On 10/10/03 MCH was 31.6. There was insufficient information to determine the reporter's causality assessment, however, the vaccinee stated that he was concerned that the vaccinations he had received may have contributed to his cardiac problems. Follow up pending. (OMIC)			Y		Y				U	02/15/2003	10/03/2003	230	A radiological examination was performed on 9/22/03, which showed that the vaccinees lungs were mildly hyperinflated, but clear of infiltrate. The heart and pulmonary vessels appeared to be of a normal size. The impression was a non-specific hyperinflation and focal degenerative changes of the left distal clavicle of the AC joint. Laboratory tests on 10/3/03 at 08:15 revealed the following: CK-MB high at 11.1u/l, relative index high at 4.8, MB confirmation high at 11.85ng/ml, and CK 231u/l. At 14:54 on 10/3/03, CK-MB Screen relative index 5.2, MB confirmation 19.36ng/ml, CK 330u/l, Troponin I 15.42 ng/ml, monocyte high at 1.2 k/ul, WBC high at 11.2 k/ul, cholesterol high at 255 mg/dl, triglyceride high at 192 mg/dl, LDL-cholesterol high at 199 mg/dl. Bacteriology results were <10,000 CPU/ml, urine was contaminated and 3 or more organisms were isolated. On 10/4/03 at 07:16, Troponin I was critically high at 5.87 ng/ml, CK was 146 u/l, calcium low at 8.9 mg/dl, anion gap low at 9 mmol/l. On 10/5/03, parasitology results were negative for occult blood. On 10/9/03, a chest x-ray revealed mild prominence of infrahilar markings, MCH was 31.8. On 10/10/03 MCH was 31.6.	UNK	UNK	Altace; Aspirin; Imdur; Lipitor; Lopressor; Plavix		Shortness of breath after exercise. Hyperlipidemia; Degenerative joint disease.		PJP200400035	1						1	Cardiac disorder; Chest pain; Dyspepsia; Electrocardiogram abnormal; Laboratory test abnormal; Myocardial infarction	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~5377AA~UNK~IM~~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~0980M~UNK~~~HEP A (HAVRIX)~1|MEN~SANOFI PASTEUR~UB269AA~UNK~SC~~MENINGOCOCCAL (MENOMUNE)~1|SMALL~PFIZER\WYETH~4020071~UNK~SC~~SMALLPOX (DRYVAX)~1|YF~SANOFI PASTEUR~UB358AA~UNK~SC~~YELLOW FEVER (YF-VAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0230227	12/09/2004		52.0			F	10/08/2004	A report was received from a health care professional on 9/2/03, concerning a 52 year old female vaccinee who inadvertently received expired Fluvirin vaccine on 9/2/03. On 9/2/03, the vaccinee inadvertently received Fluvirin vaccine. No adverse event was reported in relation to the incident. There was insufficient information to determine the reporter's causality assessment. Update 2/16/04: A follow up report was received from a health care professional indicating that no adverse event had occurred at the time of reporting. No follow up pending, all information received. See PJP200300722 and PJP200300723.									Y	09/02/2003	09/02/2003	0		UNK	UNK	NONE		NONE		PJP200300721	1						1	Medication error	FLU3~EVANS VACCINES~E33152GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230229	12/09/2004		52.0			M	10/08/2004	A report was received from a health care professional on 9/2/03 concerning a 52 year old male vaccinee who inadvertently received expired Fluvirin vaccine on 9/2/03. On 9/2/03, the vaccinee inadvertently received 2002-2003 Fluvirin vaccine. No adverse event was reported in relation to the incident. There was insufficient information to determine the reporter's causality assessment. Update 2/16/04: A follow up report was received from a health care professional indicating that no adverse event had occurred at the time of reporting. No follow up pending, all information received. See PJP200300721 and PJP200300722.									U	09/02/2003	09/02/2003	0		UNK	UNK	NONE		NONE		PJP200300723	1						1	Medication error	FLU3~EVANS VACCINES~E33152GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230230	12/09/2004		87.0	86		F	10/08/2004	A report was received from a health care professional on 9/15/03 concerning a 86 year old female vaccinee who inadvertently received 2 doses of Fluvirin vaccine, one on 9/4/03 and one on 9/15/03. On 9/4/03 and 9/15/03, the vaccinee inadvertently received 2 doses of Fluvirin (one on 9/4/03 and one on 9/15/03). At the time of the report the vaccinee had not experienced any adverse reaction. There was insufficient information to determine the reporter's causality assessment.									Y	09/04/2003	09/15/2003	11		UNK	UNK	NONE		NONE		PJP200300724	1						1	Medication error	FLU3~EVANS VACCINES~765179~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230231	12/09/2004		34.0	33		F	10/08/2004	A report was received from a health care professional on 9/26/03 concerning a 33 year old female vaccinee who experienced metallic taste in her mouth, tightness in her throat, left arm numbness, left hand numbness and numbness of the fingers on her left hand two hours after receiving Fluvirin on 9/25/03. On 9/25/03, the vaccinee experienced metallic taste in her mouth, tightness in her throat and left arm numbness radiating to the hands and fingers. There was no wheezing or shortness of breath. The vaccinee received the injection to her left deltoid muscle. The outcome of the event was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	09/25/2003	09/25/2003	0		UNK	UNK	Synthroid		Hypothyroidism		PJP200300727	1						1	Dysgeusia; Hypoaesthesia; Throat tightness	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230232	12/09/2004		0.59	0	.6	F	10/08/2004	A report was received from a health care professional on 9/29/03 concerning a 7 month old female vaccinee who inadvertently received Fluvirin on 9/29/03. On 9/29/03, the vaccinee inadvertently received Fluvirin IM in the right thigh. There was insufficient information to determine the reporter's causality assessment. Update 10/20/03: Further information received from a health care professional on 10/20/03 indicated that the vaccinee developed a slight chest rash on day two which resolved following treatment with topical Benadryl and hydrocortisone cream. No follow up pending, all information received.									Y	09/29/2003	09/29/2003	0		UNK	UNK			NONE		PJP200300728	1						1	Medication error; Rash	DTP~UNKNOWN MANUFACTURER~~3~~~DTP (NO BRAND NAME)~1|FLU3~EVANS VACCINES~765669~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~UNKNOWN MANUFACTURER~~3~~~HEP B (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~3~~~HIB (NO BRAND NAME)~1	USA		Influenza
0230234	12/09/2004					F	10/08/2004	A report was received from a healthcare professional on 9/29/03 concerning a female vaccinee in her mid 40's who experienced injection site reaction with redness, swelling, fever, malaise, and loss of voice one day after receiving Fluvirin on 9/26/03. On 9/27/03, the vaccinee experienced injection site reaction with redness, swelling, fever, malaise, and loss of voice. The swelling had resolved at the time of the report, but the other symptoms continued. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200300731 and PJP200300732. Follow up pending.									N	09/26/2003	09/27/2003	1		UNK	UNK	NONE		NONE; Scratchy throat prior to vaccination		PJP200300730	1						1	Dysphonia; Injection site erythema; Injection site swelling; Malaise; Pyrexia	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230235	12/09/2004					F	10/08/2004	A report was received from a health care professional on 9/29/03 concerning a female vaccinee in her 30's who experienced injection site reaction with redness and soreness, decreased appetite and mild total body ache one day after receiving Fluvirin on 9/26/03. On 9/27/03, the vaccinee experienced injection site reaction with redness and soreness, decreased appetite and mild total body ache. The events resolved on an unspecified date. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200300732, PJP200300730. Follow up pending.									U	09/26/2003	09/27/2003	1		UNK	UNK	NONE		NONE		PJP200300731	1						1	Decreased appetite; Injection site erythema; Injection site pain; Injection site reaction; Pain	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230236	12/09/2004		36.0			F	10/08/2004	A report was received from a health care professional on 9/29/03 concerning a 36 year old female vaccinee who experienced arm pain within 2 hours of receiving Fluvirin on 9/26/03. On 9/26/03, the vaccinee's entire arm, from the injection site to the fingertips hurt. The event resolved on 9/27/03. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200300731 and PJP200300730. Follow up pending.									U	09/26/2003	09/26/2003	0		UNK	UNK	NONE		NONE		PJP200300732	1						1	Pain	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230237	12/09/2004		1.0			U	10/08/2004	A report was received from a healthcare professional on 09/19/2003 concerning an 18 month old vaccinee of unknown sex who inadvertently received Fluvirin on an unspecified date.  On an unspecified date the vaccinee inadvertently received Fluvirin.  There was insufficient information to determine the reporter's causality assessment.									U					UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300733	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230238	12/09/2004		76.0	76		F	10/08/2004	A report was received from a healthcare professional on 09/30/2003 concerning a 75 year old female vaccinee who experienced itching of both feet 3 days after, and swelling of the feet, blistering of the feet and weeping of the feet 4 days after receiving Fluvirin on 09/25/2003.  On 09/28/2003 the vaccinee developed itching of both feet, which progressed to swelling, blistering and weeping on 09/29/2003.  There was a mild improvement on 09/30/2003.  The vaccinee was self-treating with warm soaks.  The reaction involved the distal portion of both feet, (tarsals/metartals) and dorsal and plantar surfaces of both feet.  The vaccinee had not recovered at the time of the report.  There was insufficient information to determine the reporter's causality assessment.   Update 1, 10/07/2003: Follow up information was received from a healthcare professional on 10/07/2003, indicating that the vaccinee's feet had improved but were still itchy.  On 09/30/2003, the vaccinee was prescribed one Methylprednisone dose pack.  The vaccinee is currently taking Levothyroxine, Atorvastatine, Amlodipine besilate and Estradiol oral therapy.  The vaccinee has no drug allergies and no significant past medical history. Update 2, 10/20/2003: Further information recieved from a healthcare professional on 10/20/2003 indicated that the vaccinee experienced itching and blistering of both feet on 09/27/2003.  Additionally, the vaccinee was currently taking Omeprazole oral therapy.  No follow up pending, all information received.									U	09/25/2003	09/27/2003	2		UNK	UNK	Synthroid 0.1mg Lipitor 10mg Norvasc 5mg Estrace 1mg Prilosec 20mg		No risk factors reported. Good Health.		PJP200300734	1						1	Blister; Pruritus; Swelling	FLU3~EVANS VACCINES~765142~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230239	12/09/2004		33.0	32		F	10/08/2004	A report was received from a healthcare professional on 09/30/2003 concerning a female vaccinee in her mid thirties who experienced an injection site wheal with redness, swelling and warmth when receiving Fluvirin on 09/30/2003.  The vaccinee also received less than the recommended dosage.  On 09/30/2003 the vaccinee experienced welting of the injection site during Fluvirin administration.  The vaccinee received Fluvirin intramuscularly in the left deltoid.  Approximately half way through administration the injection site because red and swollen.  The administration was stopped.  The vaccinee received approximately 0.25ml Fluvirin.  The area around the injection site felt warm and looked like a mosquito bite.  The vaccinee recovered on 09/30/2003.  There was insufficient information to determine the reporter's causality assessment.   Follow up pending. Update 1, 10/13/2003: A follow up report was received from a healthcare professional indicating that the 32 year old female vaccinee experienced an injection site wheal, eryhtema, and warmth.  The vaccinee was administered the second half of the dose on 10/01/2003 when it was certain that the redness and skin reaction had regressed.									Y	09/30/2003	09/30/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300735	1						1	Erythema; Feeling hot; Injection site erythema; Injection site swelling; Urticaria	FLU3~EVANS VACCINES~765414~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230240	12/09/2004					U	10/08/2004	A report was received from a healthcare professional on 10/02/2003 concerning an unspecified number of vaccinees under the age of 4 years who were inadvertently administered Fluvirin between 09/26/2003 and 10/01/2003.  Between 09/26/2003 and 10/01/2003 an unspecified number of vaccinees under the age of four years inadvertently received Fluvirin.  There was insufficient information to determine the reporter's causality assessment.  Follow up pending.									U					UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300740	1						1	Medication error	FLU3~EVANS VACCINES~765668~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230241	12/09/2004					U	10/08/2004	A report was received from a healthcare professional on 10/02/2003 concerning a group of 40 vaccinees who inadvertently received 1.5ml Fluvirin instead of the recommended 0.5ml from 10/01/2003 onwards. From 10/01/2003 onwards 40 vaccinees inadvertently received 1.5ml Fluvirin. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 10/10/2003: A follow up report received from a healthcare professional indicated that the vaccinees were aged between 61 and 95 years of age.  There were 31 females and 9 males.  No adverse events were reported in association with the incident.									U	10/01/2003				UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300741	1						1	Medication error	FLU3~EVANS VACCINES~765273~3~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230242	12/09/2004		35.0			F	10/08/2004	A report was received from a healthcare professional on 10/02/2003 concerning a 35 year old female vaccinee who experienced malaise, soreness at the injection site and developed mild to moderate total body ache after inadvertently receiving expired Fluvirin vaccine on 09/30/2003. On 09/30/2003, the vaccinee felt ill, had mild to moderate total body ache on 10/01/2003 and had soreness at the injection site a couple of hours following vaccination.  The body ache had improved at the time of the report, however the soreness was continuing at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 01/02/2003: Further information was received from a healthcare professional on 01/02/2004 indicating that the vaccinee received Fluvirin on approximately 10/01/2003.  The vaccinee experienced redness on her arm and soreness the following day 10/02/2003.  The redness on the arm and the soreness resolved 2-3 days later.   Follow up pending.									Y	09/30/2003	09/30/2003	0		UNK	UNK	Premarin Multivitamin		No risk factors reported.		PJP200300744	1						1	Erythema; Injection site pain; Medication error; Pain	FLU3~EVANS VACCINES~30112GA~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230243	12/09/2004		55.0			F	10/08/2004	A report was received from a healthcare professional on 10/02/2003 concerning a 55 year old female vaccinee who experienced redness at the injection site an unspecified length of time after inadvertently receiving expired Fluvirin vaccine on 09/30/2003. On 09/30/2003 the vaccinee inadvertently received expired Fluvirin vaccine and an unspecified time later the vaccinee experienced redness at the injection site.  The outcome was unknown at the time of the report. There was insufficient information to determine the reporter's causality assessment.									U	09/30/2003				UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300745	1						1	Medication error	FLU3~EVANS VACCINES~30112GA~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230244	12/09/2004					M	10/08/2004	A report was received from a healthcare professional on 10/02/2003 concerning a male vaccinee in his 50's who inadvertently received expired Fluvirin vaccine on 09/30/2003. On 09/30/2003 the vaccinee inadvertently received expired Fluvirin vaccine.  No adverse reaction had occurred at the time of the report. There was insufficient information to determine the reporter's causality assessment.									U	09/30/2003				UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300746	1						1	Medication error	FLU3~EVANS VACCINES~30112GA~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230245	12/09/2004		74.0	73		F	10/08/2004	A report was received from a healthcare professional on 10/03/2003 concerning a 73 year old female vaccinee who experienced hyperglycemia in the evening of 10/02/2003 after receiving Fluvirin vaccine in the afternoon of 10/02/2003. On 10/02/2003, the vaccinee was administered Fluvirin vaccine in the afternoon and later that evening the vaccinee noted that her finger stick blood sugar tests were reading 400mg/dl.  The tests were repeated twice and they all yielded a result in the 400mg/dl range.  The vaccinee self administered an extra 10 units of insulin subcutaneously as a result of her hyperglycemia.  The vaccinee did not exhibit any outward signs or symptoms of hyperglycemia.  The vaccinee did not exhibit any outward signs or symptoms hyperglycemia.  On the morning of 10/03/2003, the vaccinee's fasting blood glucose was approximately 50mg/dl.  Her normal fasting blood glucose is between 50mg/dl to 80mg/dl.  The vaccinee's normal dose of insulin of 40 units subcutaneously every morning was resumed.  The vaccinee has had perfect control of her diabetes for 5 years.  The outcome of the event was not reported.   There was insufficient information to determine the reporter's causality assessment. Update 1, 11/10/2003: Further information received from a healthcare professional on 11/10/2003 indicated that the vaccinee developed a fasting blood glucose of 400mg/dl on 10/03/2003, which resolved the following morning on 10/04/2003 following an extra insulin dose. No follow up pending.									Y	10/02/2003	10/03/2003	1		UNK	UNK	Lisinopril 5mg Acetylsalicylic Acid 81mg		No risk factors reported. 5 years history of perfect control of her diabetes type I. Essential Hypertension.		PJP200300750	1						1	Hyperglycaemia	FLU3~EVANS VACCINES~765138~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230246	12/09/2004					F	10/08/2004	A report was received from a healthcare professional on 10/03/2003 concerning a female vaccinee of approximately 30 years of age who experienced an injection site.  The area was not itchy.  The swelling resolved on 10/02/2003.  The redness covered an area of approximately 3 inches by 2 inches.  The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/02/2003	10/02/2003	0		UNK	UNK			No risk factors reported.		PJP200300751	1						1	Erythema; Swelling	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230247	12/09/2004					U	10/08/2004	A report was received from a health care professional on 3OCT2003 concerning 9 vaccinees of unknown demography who inadvertently received expired Fluvarin vaccine on an unknown date. On an unknown date, 9 vaccinees inadvertently received expired Fluvirin vaccine. No adverse events wee reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK					PJP200300752	1						1	Medication error	FLU3~EVANS VACCINES~E32972GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230248	12/09/2004					U	10/08/2004	A report was received from a health care professional on 3OCT2003 concerning 4 vaccinees of unspecified demography who experienced unspecified adverse events 2 to 3 days after receiving fluvirin on an unknown date in 2003. Since 18SEPT2003 the reporter had received 4 adverse event reports associated with Fluvirin administration. It was not reported if the vaccinees had recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending: See Ref: PJP200301080,  RJP200301081, RJP200301082									U					UNK	UNK					PJP200300753	1						1	Unevaluable event	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230249	12/09/2004		49.0	48		F	10/08/2004	A repot was received from a health care professional on 6OCT2003 concerning a female vaccine in her late thirties who experienced local sensitivity at the injection site on the same day as receiving Fluvirin vaccine on 3OCT2003 and shoulder joint pain which made it difficult to raise her arm an unspecified number of days after vaccination. On 3OCT2003 the vaccinee experienced local sensitivity at the injection site. An unspecified number of days later the vaccinee developed a shoulder joint pain that made it difficult for her to raise her arm. The vaccinee was to seek treatment from her physician. There was insufficient information to determine the reporter's causality assessment. Update 1 23DEC2003: A follow up report received from a health care professional which indicated that the 48 year old female vaccinee experienced shoulder joint ache on 4OCT2003. The shoulder joint ache resolved on 6OCT2003. no action was taken to treat this reaction. It was not reported if local sensitivity at the site of injection had resolved. Follow up pending.									U	10/03/2003	10/03/2003	0		UNK	UNK					PJP200300754	1						1	Arthralgia; Injection site reaction; Joint range of motion decreased	FLU3~EVANS VACCINES~765146~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230250	12/09/2004		64.0	63		M	10/08/2004	A report was received from a health care professional on 6OCT2003 concerning a 63 year old male vaccinee who inadvertently expired Fluvirin vaccine on 30SEPT2003. On 30SEPT2003, the vaccinee inadvertently received 2002-2003 Fluvirin vaccine. No adverse effect was reported. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200300760.									U	09/30/2003	09/30/2003	0		UNK	UNK					PJP200300759	1						1	Unevaluable event	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230251	12/09/2004		39.0	39		F	10/08/2004	A report was received from a health care professional on 6OCT2003 concerning a 39 year old female vaccinee who inadvertently received expired Fluvirin vaccine on 30SEPT2003. On 30SEPT2003, the vaccinee inadvertently received 2002-2003 Fluvirin vaccine. No adverse effect was reported. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200300759.									U	09/30/2003	09/30/2003	0		UNK	UNK					PJP200300760	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230252	12/09/2004		34.0			M	10/08/2004	A repot was received from a health care professional on 3OCT2003 concerning a 34 year old male vaccinee who inadvertently received expired Fluvirin vaccine on 3OCT2003. On 3OCT2003, the vaccine inadvertently received 2002 Fluvirin vaccine. No adverse effect was reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 2January 2004: Further information was received from a health care professional on 2JAN2004 indicating the vaccinee experienced no adverse reaction. No follow up pending, all information received. Cross reference PJP200300762.									U		10/03/2003			UNK	UNK					PJP200300761	1						1	Unevaluable event	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230253	12/09/2004		44.0	43		F	10/08/2004	A repot was received from a health care professional on 3OCT2003 concerning a 44 year old female vaccinee who inadvertently received expired Fluvirin vaccine on 3OCT2003. On 3OCT2003, the vaccine inadvertently received 2002 Fluvirin vaccine. No adverse effect was reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 2January 2004: Further information was received from a health care professional on 2JAN2004 indicating the vaccinee experienced no adverse reaction. No follow up pending, all information received. Cross reference PJP200300761.									U	10/03/2003	10/03/2003	0		UNK	UNK					PJP200300762	1						1	Medication error	FLU3~EVANS VACCINES~E33352GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230254	12/09/2004		40.0	39		M	10/08/2004	A repot was received from a health care professional on 7OCT2003 concerning a 39 year old male vaccinee who experienced an accidental overdose, after inadvertently receiving Fluvirin vaccine on 29SEPT2003 and again on 3OCT2003. On 3OCT2003, the vaccinee experienced an accidental overdose after inadvertently receiving a second Fluvirin vaccination 4 days after the first vaccination. No adverse effects were reported at time of report. There was insufficient information to determine the reporter's causality assessment. Update 1 28OCT2003: Follow up information received from a health care professional indicated that the vaccinee had still not experienced any adverse reaction at the time of this report. No follow up pending.									U	09/29/2003	10/03/2003	4		UNK	UNK	Synthroid		Hypothyroidism		PJP200300763	1						1	Medication error	FLU3~EVANS VACCINES~765144~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230255	12/09/2004		1.93	1	.9	F	10/08/2004	A report was received from a health care professional on 7OCT2003 concerning a two year old female vaccinee who inadvertantly administered Fluvirin 0.25ml vaccine IM on 7OCT2003. On 7OCT2003, one does of Fluvirin 0.25ml was administered IM to a two year ld vaccine. No adverse event was noted or reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. No follow up pending.									U	10/07/2003	10/07/2003	0		UNK	UNK					PJP200300764	1						1	Medication error	FLU3~EVANS VACCINES~765703~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230256	12/09/2004					F	10/08/2004	A report was received from a health care professional on 7OCT2003, concerning a female vaccinee who inadvertantly received Fluvirin vaccine SC on 6OCT2003. On 6OCT2003, an obese female vaccinee inadvertantly received a 0.51 Fluvirin dose SC instead of IMwith the use of a 5/8 inch needle. No adverse signs or symptoms were noted at the time of the report. There was insufficient information to determine the reporter's causality assessment. Further information was received from a health care professional on 2JAN2004 indicating that no adverse outcome was reported. No follow up pending as no further information is available.									U	10/06/2003	10/06/2003	0		UNK	UNK					PJP200300765	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230257	12/09/2004					U	10/08/2004	A report was received form a health care professional on 7OCT2003 concerning 50 vacinees of less than 4 years of age who inadvertently received 0.5ml fluvirin vaccine on an unspecified date. On an unspecified date 50 vaccinees inadvertently received Fluvirin 0.5ml. No adverse event had occurred at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK					PJP200300766	1						1	Unevaluable event	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230259	12/09/2004		28.0	28		F	10/08/2004	A report was received from a healthcare professional on 10/07/2003 concerning a 28 year old female vaccinee who developed a swollen, aching arm, flu-like symptoms including body aches and a sore throat on 10/03/2003 after receiving Fluvirin vaccine on 10/03/2003. The vaccinee's arm became swollen and ached following vaccination.  That evening the vaccinee experienced flu-like symptoms including body aches and a sore throat.  The practice doctor and a co-worker who administered the vaccine were also given the same vaccination and both experienced the same symptoms.  The vaccinee had recovered at the time of the report. There was insuffcient information to determine the reporter's causality assessment. Follow up pending.									Y	10/03/2003	10/03/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300768	1						1	Influenza like illness; Pain; Pharyngolaryngeal pain; Swelling	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230261	12/09/2004		41.0	40		F	10/08/2004	A report was received from a healthcare professional on 10/08/2003 concerning a 40 year old female vaccinee who experienced fever, chills and joint ache and developed an edematous rash following vaccination with 0.5ml Fluvirin vaccine on 10/06/2003. On 10/06/2003, the vaccinee was administered 0.5 ml Fluvirin vaccine in her deltoid muscle.  The vaccinee self-administered ibuprofen and her symptoms improved.  On the morning of 10/08/2003, approximiately 36 hours after Fluvirin administration, the vaccinee developed an edematous rash (not maculopapular) which appeared as patches on her trunk, shoulder and back.  The rash was not described as pruritic but is currently progressing and worsening. There was insufficient information to determine the reporter's causality assessment. Update 1, 11/07/2003: Further information received from a healthcare professional on 11/07/2003 indicated that the vaccinee's rash was probably due to an allergy to neomycin.  The vaccinee also experienced myalgias within 12 hours of receiving Fluvirin.  The rash resolved within 48 hours and the fever and chills and the myalgias resolved following treatment with ibuprofen. No follow up pending, all information received.									Y	10/06/2003	10/06/2003	0		UNK	UNK	Concomitant drug not used.		No risk factors reported. Allergies to sulfa drugs, clindamycin (rash) and a questionable allergy to tobramycin (rash) and ceftazidime (rash and hives) and received the Flu vaccine (brand unspecified) 2 years ago without complications. Spina Bifida.		PJP200300770	1						1	Arthralgia; Myalgia; Pyrexia; Rash	FLU3~EVANS VACCINES~765499~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230262	12/09/2004		41.0	41		M	10/08/2004	A report was received from a healthcare professional on 10/08/2003 concerning a 41 year old male vaccinee who experienced shaking, chills, fever and memory loss on 10/07/2003 after receiving 0.5ml Fluvirin on 10/06/2003. On 10/06/2003, in the afternoon, the vaccinee received Fluvirin 0.5ml intramuscularly in his left deltoid muscle.  On the morning of 10/07/2003, the vaccinee developed shaking, chills and fever.  Furthermore, the vaccinee did not recall what occurred that morning including conversations with his family members.  All of the symptoms have completely self-resolved within 12 hours of onset. There was insufficient information to determin the reporter's causality assessment. Update 1, 11/03/2003: Further information received from a healthcare professional on 11/03/2003 indicated that the vaccinee woke at 05:00 hours on 10/07/2003 after receiving Fluvirin 12-13 hours previously.  He developed uncontrollable shaking chills, myalgias and he was hallucinating.  The vaccinee stated that he did not recognize his own father.  The hallucinations resolved on 10/07/2003 and the shaking chills, myalgias and fever resolved on 10/08/2003.  The vaccinee was advised not to take the Flu vaccine again. The reporter has assessed the relationship of the vaccine to the shaking chills, hallucinations, myalgias and fever as probable. No follow up pending, all information received.									Y	10/06/2003	10/07/2003	1		UNK	UNK	Azmacort Nsacort Albuterol Prozac Phentermine				PJP200300772	1						1	Amnesia; Hallucination; Myalgia; Pyrexia; Tremor	FLU3~EVANS VACCINES~765180~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230263	12/09/2004					U	10/08/2004	A report was received from a healthcare professional on 10/09/2003 concerning a group of 8 vaccinees aged less than 4 years of age, who were inadvertently administered Fluvirin vaccine between 10/06/2003 to 10/08/2003. During 10/06/2003 to 10/08/2003, a group of 8 vaccinees aged less than 4 years of age received Fluvirin vaccine.  No adverse symptoms occurred. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/06/2003				UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300779	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230264	12/09/2004		56.0	55		F	10/08/2004	A report was received from a health care professional on 10/09/03 concerning a (approximately 50 year old female vaccinee who experienced swelling in her arm on 10/8/03 and developed a red rash on 10/9/03 after receiving Fluvirin vaccine on 10/8/03. On 10/08/03 the vaccinee was administered Fluvirin and later that evening she developed swelling in her arm. On the morning of 10/09/03, the vaccinee had a 1x2 red rash. The vaccine has no medical conditions, has no allergies (specifically no allergies to eggs or thiomersal) and is not taking any medication. The outcome of the event was not reported. There was insufficient information to determine the reporter's causality assessment. Update1, 11/4/2003, Follow up information received from a health care professional indicated that the vaccinee was 55 years old. The vaccinee experienced swelling at the injection site on 10/7/03 and a 1x2 rash at the injection site on 10/08/2003 after receiving Fluvirin on 10/7/2003. The vaccinees symptoms abated two days after the injection. The reporter has assessed the relationship of the vaccine to the events as probable. No follow up pending.									Y	10/07/2003	10/07/2003	0		UNK	UNK	Prempro 0.625/2.5 Daily		No risk factors reported. Menopause (started in 1987)		PJP200300780	1						1	Injection site rash; Injection site swelling	FLU3~EVANS VACCINES~765669~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230265	12/09/2004					U	10/08/2004	A report was received from a health care professional on 9OCT2003 concerning 2 vaccinees of unknown demography who inadvertently received expired Fluvarin vaccine on an unknown date. On an unknown date, 2 vaccinees received a dose of Fluvirin which expired on 30June2003. No adverse events were reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK					PJP200300782	1						1	Unevaluable event	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230266	12/09/2004					U	10/08/2004	A report was received from a health care professional on 10/10/2003 concerning 5 vaccinees of unknown demography who inadvertently received expired Fluvirin vaccine on 10/03/2003. No adverse reactions were reported. There was insufficient information to determine the reporter's causality assessement. Follow up pending.									U	10/03/2003	10/03/2003	0		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200300783	1						1	Medication error	FLU3~EVANS VACCINES~E30152GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230267	12/09/2004		1.69	1	.7	F	10/08/2004	A report was received from a health care professional on 10/10/2003 concerning a 20 month old female vaccinee who inadvertently received Fluvirin vaccine on 10/10/03. On 10/10/03, the vaccinee inadvertently received Fluvirin 0.25ml intramuscularly in the thigh. This was the vaccinee's first dose. No adverse reaction was reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 11/7/03: Further information received from a health care professional on 11/07/03 indicated that the reported telephoned the vacinees' home two days after vaccination and no adverse reaction was reported. No follow up pending.									U	10/10/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300784	1						1	Medication error	FLU3~EVANS VACCINES~765181~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230268	12/09/2004		43.0	42		F	10/08/2004	A report was received from an health care professional on 10/09/2003 concerning a 42 year old female vaccinee who experienced redness, warmth, itching and developed a quarter-sized knot at the injection site on 10/09/03 after receiving Fluvirin vaccine on 10/09/2003.  The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update1, 11/4/2003: Further information received from a health care professional on 11/4/2003 indicated that the vaccinee received Fluvirin vaccine on 10/08/2003.  The event duration was 4 days, resolving on 11/13/2003. No follow up pending, all information received.									Y	10/08/2003	10/09/2003	1		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300785	1						1	Injection site erythema; Injection site hypersensitivity; Injection site mass; Injection site warmth; Pruritus	FLU3~EVANS VACCINES~765178~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230269	12/09/2004		41.0	41		F	10/08/2004	A report was received from a health care professional on 10/092003 concerning a 41 year old female vaccinee who experienced redness, warmth and itching at the injection site on 10/09/03 after receiving Fluvirin vaccine on 10/09/03. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 11/4/2003: Further information received from a health care professional on 11/4/03 indicated that the vaccinee received Fluvirin vaccine on 10/7/03. The event duration was 4 to 5 days. the vaccinee also experienced a grapefruit sized knot an unspecified length of time after receiving Fluvirin. No follow up pending, all information received. Cross reference with: PjP-2003-00785, PJP-2003-00987, PJP-2003-00988.									N	10/07/2003	10/09/2003	2		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200300786	1						1	Injection site erythema; Injection site hypersensitivity; Injection site mass; Injection site warmth; Pruritus	FLU3~EVANS VACCINES~765178~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230270	12/09/2004					U	10/08/2004	A report was received from a health care professional on 10OCT2003 concerning an unspecified number of children of unspecified age who received Fluvirin from an unspecified date to 10OCT2003. From an unspecified date to 10OCT2003 an unspecified number of vaccinees of unspecified age received Fluvirin. To the reporter's knowledge no adverse reactions had occurred. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK					PJP200300787	1						1	Unevaluable event	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230271	12/09/2004					U		A report was received from a health care professional on 9OCT2003 concerning two vaccinees of unknown demography who experienced fever, night sweats, stiff joints and headache on 7OCT2003 after receiving Fluvirin vaccine on 7OCT2003. on 7OCT2003, two vaccinees received Fuvirin and later that evening they both experienced fever of 101-102 degrees Fahrenheit, night sweats, stiff joints and headache. The vaccinees' symptoms improved on 9OCT2003. There was insufficient information to determine the reporter's causality assessment. No follow up pending as the reporter will not collect any further information. Update 1. 17DEC2003.  A follow up report was received form a health care professional concerning a male vaccinee, of unspecified age who experienced fever, night sweats, stiff joints, headache and achiness all over on 7OCT2003 after receiving Fluvirin vaccine on the same day. On 7OCT2003 the vaccine experienced fever, night sweats, stiff joints, headache and achiness all over following Fluvirin vaccination. No follow up pending as the reporter will not collect any further information. Master file. Cross Reference with PJP200400060.									U	10/07/2003	10/07/2003	0		UNK	UNK					PJP200300788	1						1	Headache; Hyperhidrosis; Joint stiffness; Pain; Pyrexia	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230272	12/09/2004		25.0	24		M	10/08/2003	A report was received from a health care professional on 8OCT2003 concerning a vaccinee of unknown demography who experienced pain at the injection site and supraclavicular lymph node sweling and pain an unspecified length of time after receiving Fluvirin vaccine on an unspecified day in October 2003. On an unspecified day in October 2003 the vaccinee experienced pain at the injection site that radiated up tot he shoulder and neck area, and supraclavicular lymph node sweling and pain after receiving Fluvirin. The pain occurred on the same side of the body as the injection site. The outcome of the event was not reported. The reporter had administered approximately 80 Fluvirin injections to date this flu season. There was insufficient information to determine the reporter's causality assessment. Update 1, 10NOV2003: Further information received from a health care professional on 10NOV2003 indicated that the vaccinee was a 24 year old male. The vaccinee experienced supraventricular lymphadenopathy approximately 1 to 2 days after receiving Fluvirin on 3OCT2003. The vaccinee previously received a flu vaccination without any adverse effect. The supraventricular lymphadenopathy was assumed to have resolved 5 to 7 days following vaccination. The reporter had assessed the relationship of the vaccine  to thesupraventricular lymphadenopathy as probable. No follow up pending . Cross reference with : RJP200300827.									U	10/03/2003				UNK	UNK					PJP200300790	1						1	Injection site pain; Lymphoedema; Neck pain; Pain	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230273	12/09/2004		51.0	51		F	10/08/2004	On 9OCT2003 at 12:00 the vaccinee developed erythema at the injection site after receiving Fluvirin in her left deltoid muscle on 8OCT2003. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 10NOV2003: Further information received from a health care professional on 10NOV2003 indicated that the vaccinee received Fluvirin on 9OCT2003. The vaccinee experienced erythema at the injection site on 10OCT2003 and recovered three days later. No follow up pending. Cross reference with : PJP200300792, PJP200300793, PJP200301113									Y	10/09/2003	10/10/2003	1		UNK	UNK					PJP200300791	1						1	Injection site erythema	FLU3~EVANS VACCINES~765703~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230274	12/09/2004		30.0	29		F	10/08/2004	On 9OCT2003 at 12:00 the vaccinee developed large erythema at the injection site after receiving Fluvirin in her left deltoid muscle on 8OCT2003. The vaccinee had not recovered at  the time of the report. There was insufficient information to determine the reporter's causality assessment. Further information received from a health care professional on 10NOV2003 indicated that the vaccinee received Fluvirin on 9OCT2003. The erythema at the injection site began on 10OCT2003 and resolved 3 days later. The vaccine is pregnant and in her first trimester. Follow up pending. Cross reference with: PJP200300791, PJP200300793, PJP200301113. Follow up received 29JUNE2004. Vaccinee had a positive pregnancy test on 9OCT2003 (day of vaccination). The vaccines gave birth to a normal healthy baby girl on 2JUNE2004; the baby was delivered by repeat Caesarean Section with no complications. Concomitant medications during pregnancy included, prenatal vitamins, nitrofurantoin for urinary tract infection and amoxicillin for bronchitis.									Y	10/09/2003	10/10/2003	1		UNK	UNK	Macrobid, Amoxicillin		Pregnant:LMP 9/4/03 sex:female		PJP200300792	1						1	Injection site erythema	FLU3~EVANS VACCINES~765703~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230275	12/09/2004		30.0			F	10/08/2004	A report was received from a healthcare professional on 10/09/2003, concerning a 30 year old female vaccinee who developed large erythema at the injection site and experienced fever, headache, and joint pain on 10/09/2003 after receiving Fluvirin vaccine on 10/08/2003. On 10/09/2003 at 9:00 the vaccinee developed large erythema at the injection site and experienced fever, headache and joint pain after receiving Fluvirin in her left deltoid muscle on 10/08/2003.  The vaccinee was administered diphenhydramine hydrochloride and ibuprofen for her symptoms.  The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 11/10/2003: Further information received from a healthcare professional on 11/10/2003 indicated that the vaccinee received Fluvirin on 10/09/2003.  The vaccinee also experienced vomiting on the night of 10/09/2003.  The vaccinee was out of work for 2 days.  The fever, joint pain and vomiting resolved 2 days later. No follow up pending.									Y	10/08/2003	10/09/2003	1		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300793	1						1	Arthralgia; Headache; Injection site erythema; Pyrexia; Vomiting	FLU3~EVANS VACCINES~765703~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230276	12/09/2004		57.0			U	10/08/2004	A report was received from a consumer on 10OCT2003 concerning a 57 year old female vaccinee who experienced aches 2 days after receiving Fluvirin on 2OCT20036, and sore throat, congestion and cough three days after vaccination. On 4OCT2003 the vaccinee experienced aches and then on 5OCT2003 the vaccinee experienced flu symptoms including aches, congestion, sore throat and coughing but no fever. The vaccinee contacted a hospital and was advised to take ibuprofen. She also took saline nasal drugs for nasal congestion, menthol and camphor applied topically at bedtime and zinc salts every six hours for symptoms relief. The vaccinee had not recovered at the time of the report. No follow up. Permission not granted to contact treating physician. Cross reference with PJP200300794.									U	10/02/2003	10/04/2003	2		UNK	UNK					PJP200300795	1						1	Cough; Nasal congestion; Pain; Pharyngolaryngeal pain	FLU3~EVANS VACCINES~765501~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230277	12/09/2004		2.0			F	10/08/2004	A report was received from a health care professional on 13OCT2003 concerning a 2 year old female vaccinee who inadvertantly received one dose of Fluvirin on 10OCT2003. The vaccinee had experienced no adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/13/2003	10/13/2003	0		UNK	UNK					PJP200300796	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230278	12/09/2004		58.0			M	10/08/2004	A report was received from a health care professional on 13OCT2003 concerning a 58 year old male vaccinee who inadvertently received expired 2002-2003 formulation of Fluvirin on 13OCT2003. The vaccinee had experienced no adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/13/2003	10/13/2003	0		UNK	UNK					PJP200300797	1						1	Medication error	FLU3~EVANS VACCINES~E30152GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230279	12/09/2004		43.0	42		F	10/08/2004	A report was received from a health care professional on 13OCT2003 who is a 43 year old female vaccinee who experienced severe body aches, myalgias, arthralgias and fever on the same day as receiving Fluvirin vaccine on 9SEPT2003. On 9SEPT2003, the vaccine experienced severe body aches, myalgias, arthralgias and fever with temperature spikes as high as 103 degrees Fahrenheit. The vaccinee was administered 800 mg ibuprofen every 6 hours and 325 mg acetaminophen every 4 hours. The vaccinees symptoms persisted through most of 10SEPT2003 until 22:00 hours, at which time her fever and other associated symptoms resolved. Since 10 SEPT2003, and up to the time of the report the vaccinees symptoms have not returned. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	09/09/2003	09/09/2003	0		UNK	UNK					PJP200300798	1						1	Arthralgia; Myalgia; Pain; Pyrexia	FLU3~EVANS VACCINES~765485~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230280	12/09/2004		25.0			F	10/06/2004	A report received from a health care professional on 14OCT2003 concerning a 25 year old female vaccinee who experienced a red, hot, sore injection site the day after receiving Fluvirin vaccine on 10OCT2003. On 11OCT2003, the vaccinee experienced a red, raised, hot to touch, sore area about 1.5 inches in diameter at the site of injection after receiving Fluvirin vaccine on 10OCT2003. The adverse reaction was not yet resolved at the time of reporting but the vaccinee is currently improving. There was insufficient information to determine the reporter's causality assessment. Update 1, 18MAR2004: A follow up report was received from a health care professional indicating that the vaccinee experienced a red raised heated area 24 hours after receiving Fluvirin. The vaccinee recovered from the red, raised heated area in 48 hours. The outcomes of the events reported initially were not reported. No follow up pending, all information received. Reference PJP200300802. PJP20300803									U	10/10/2003	10/11/2003	1		UNK	UNK					PJP200300801	1						1	Injection site erythema; Injection site swelling; Injection site warmth; Tenderness	FLU3~EVANS VACCINES~765484~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230281	12/09/2004		28.0			F		A report was received from a health care professional on 13OCT2003, concerning a 28 yar old female vaccinee who developed a red,hot, painful injection site, and a rash on her left leg on the same day as receiving Fluvirin on 10OCT2003. On 10OCT2003 the vaccinee developed a red, raised , hot to touch, painful area about 1-1.5 inches in diameter at the site of injection, and a rash on her left leg after receiving Fluvirin on the same day. The vaccinee was improving at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1, 18MAR2004: A follow up report was received from a health care professional indicating that the vaccinee also experienced itching and flu-like symptoms. The time to onset was reported as 8 hours. The vaccinee recovered after 72 hours. The outcome of the events reported initially was not reported except for the rash which was reported as resolved. No follow up pending, all information received. References: PJP200300801, PJP200300803.									U	10/10/2003	10/10/2003	0		UNK	UNK					PJP200300802	1						1	Influenza like illness; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pruritus; Rash	FLU3~EVANS VACCINES~765484~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230282	12/09/2004		49.0			F	10/08/2004	A report was received from a healthcare professional on 10/13/2003 concerning a 49 year old female vaccinee who developed a red, hot, painful, itchy injection site, a bumpy rash on her thighs, and she felt agitated and flushed on the day after receiving Fluvirin on 10/10/2003. On 10/11/2003, the vaccinee developed a red, raised, hot to touch, painful, itchy 4-5 inch area at the site of injection, a bumpy rash on her thighs, and she felt agitated and flushed after receiving Fluvirin on 10/10/2003.  The vaccinee was improving at the time of reporting. There was insufficient information to determine the reporter's causality assessmen. Update 1, 03/18/2004: A follow up report was received from a healthcare professional indicating that the vaccinee experienced a raised rash, itching and was warm to touch 12 hours after receiving Fluvirin.  The reporter indicated that the affected arm looked like a burn.  The vaccinee recovered 84 hours later.  The outcome of the events reported initially was not reported. No follow up pending, all information received.									U	10/10/2003	10/11/2003	1		UNK	UNK	Synthroid Lipitor Celebrex Allegra		No risk factors reported.		PJP200300803	1						1	Agitation; Flushing; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pruritus; Rash	FLU3~EVANS VACCINES~765484~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230283	12/09/2004					U	10/08/2004	A report was received from a healthcare professional on 10/14/2003 concerning a vaccinee of unknown demography who received expired Fluvirin on an unspecified date. On an unspecified date the vaccinee received expired Fluvirin.  The vaccinee did not experience any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1. 22 December 2003. The expired Fluvirin was administered to three vaccinees.  No specific information was available on the vaccinees.  No adverse effects had occurred as a result, as the time of this report.  No follow-up pending.									U					UNK	UNK	Concomitant Drug not reported.		No risk factors reported.		PJP200300806	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230284	12/09/2004					U	10/08/2004	A report was received from a healthcare professional on 10/14/2003 concerning an unspecified number of vaccinees of unknown demography who received double the recommended dose of Fluvirin on 10/14/2003. On 10/14/2003 an unspecified number of vaccinees received double the recommended dose of Fluvirin.  The reporter did not have vaccinee demographics or specifics on any adverse events at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 20 February 2004. A follow-up report was received from a healthcare professional indicating that 96 females, 29 males and 23 vaccinees of unspecified gender and all of unknown age received Fluvirin.  No adverse events were reported. No follow-up pending, all information received.									U	10/14/2003	10/14/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300807	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230285	12/09/2004					M	10/08/2004	A report was received from a consumer on 10/14/2003 concerning an unspecified number of vaccinees less than 4 years of age who received Fluvirin subcutaneously on an unspecified date. On an unspecified date an unspecified number of vaccinees less than 4 years of age received Fluvirin subcutaneously.  The reporter indicated that the exact number was unknown but was believed to involve less than 20 vaccinees.  Vaccinees aged between 6 and 35 months were given 0.25ml and 0.5ml was given to vaccinees greater than 35 months.  No adverse symptoms had been noted. Follow up pending. Update 1, 7 November 2003: A follow up report was received from a consumer indicating that a male vaccinee less than 4 years of age received Fluvirin intramuscularly on 10/13/2003.  No adverse reaction had occurred at the time of the report.									U	10/13/2003	10/13/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300808	1						1	Nonspecific reaction	FLU3~EVANS VACCINES~~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230286	12/09/2004			0	.7	M	10/08/2004	A report was received from a healthcare professional on 10/14/2003 concerning an 8 month old male vaccinee who received Fluvirin on 10/14/2003.  On 10/14/2003 the vaccinee inadvertently received 0.25ml Fluvirin intramuscularly.  No adverse effects were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 24 November 2003  Follow-up information received from a healthcare professional indicated that the vaccinee did not experience any adverse reaction.									U	10/14/2003				UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300809	1						1	Medication error	FLU3~EVANS VACCINES~~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230287	12/09/2004		27.0	27		F	10/08/2004	A report was received from a healthcare professional on 10/15/2003 concerning a group of approximately 15 vaccinees who experienced injection site reaction, with redness, swelling and itching a few minutes after receiving Fluvirin on an unspecified date. On an unspecified date the vaccinees experienced injection site reactions with redness, swelling, and itching.  The vaccinees recovered on an unspecified date without treatment. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 22 December 2003. A follow up report was received from a healthcare professional concerning a 27 year old female vaccinee who experienced redness, swelling and severe itching at the injection site on the same day as  receiving Fluvirin on 10/10/2003. On 10/10/2003, the vaccinee experienced redness, swelling and severe itching at the injection site after receiving Fluvirin 0.5ml.  The symptoms lasted for a duration of 24 hours, and had resolved at the time of follow up report. No follow up pending.									Y	10/10/2003	10/10/2003	0		UNK	UNK	Concomitant drugs not reported.		No risk factors reported.		PJP200300810	1						1	Injection site erythema; Injection site reaction; Injection site swelling; Pruritus	FLU3~EVANS VACCINES~765484~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230288	12/09/2004		50.0			M	10/08/2004	A report was received from a consumer on 10/15/2003 concerning a 50 year old male vaccinee who experienced neurological symptoms with shaking at the back of the head and alteration of mental status approximately 5 hours after vaccination on an unspecified date. On an unspecified date the vaccinee experienced neurological symptoms with shaking at the back of the head and alteration of mental status described as a dream-like or fog-like state.  The vaccinee recovered on an unspecified date without sequalae or treatment.  The vaccinee developed similar neurological symptoms (though not as marked) in the past after receiving antibiotics and unspecified pain medications. Follow up pending.									Y					UNK	UNK	Concomitant drug not reported.		No risk factors reported. Developed neurological symptoms in the past after receiving antibiotics and unspecified pain medications.		PJP200300811	1						1	Mental impairment; Neuropathy; Tremor	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230289	12/09/2004					U	10/08/2004	A report was received from a healthcare professional on 10/15/2003 concerning a group of vaccinees of unknown demography who received an accidental overdose of Fluvirin on approximately 8 October 2003. On approximately 8 October 2003 a group of vaccinees were inadvertently administered 1ml Fluvirin instead of the recommended dose of 0.5ml.  No adverse events were reported in relation to the overdosing. There was insufficient information to determine the reporter's causality assessment. Update 1, 17 November 2003 Follow up information received from a healthcare professional indicated that possibly 19 vaccinees inadvertently received 1ml Fluvirin. Follow up pending.									U	10/08/2003	10/08/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300812	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230290	12/09/2004		93.0	92		F	10/08/2004	A report was received from a health care professional on 10/16/2003 concerning a 92 year old female vaccine who inadvertently received a accidental overdose of Fluvirin on 10/16/2003. On 10/16/2003 the vaccinee had previously been vaccinated with Fluvirin on 10/03/2003. There was insufficient information to determine the reporter's causality assessment.									U	10/16/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported. History of high blood pressure and non insulin dependent diabetes.		PJP200300813	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~756178~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230291	12/09/2004					U	10/08/2004	A report was received from a health care professional concerning 4 vaccinees of unspecified demography who experienced injection site bruising, swelling, warmth and erythema of an unspecified length of time after receiving Fluvirin between 10/10/2003 and 10/16/2003. It was not reported if the vaccinees had recovered. There was insufficient information to determine the reporters Causality assessment. Follow up pending.									U					UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200300816	1						1	Contusion; Injection site erythema; Injection site swelling; Injection site warmth	FLU3~EVANS VACCINES~765137~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230292	12/09/2004		52.0	51		M	10/08/2004	A report was received from a healthcare professional on 10/17/2003 concerning a 51 year old male vaccinee who received Fluvirin intravenously on 10/17/2003. On 10/17/2003 Fluvirin was administered via an intravenous push when the vaccinee was undergoing dialysis.  The vaccinee did not complain of any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 20 February 2004. A follow up report was received from a healthcare professional reporting no adverse event. No follow up pending, all information received.									U	10/17/2003	10/17/2003	0		UNK	UNK	Norvasc Phoslo Gel Caps Clonidine		No risk factors reported. Hypertension. Hyperphosphataemia.		PJP200300817	1						1	Medication error	FLU3~EVANS VACCINES~765410~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230293	12/09/2004		57.0			F	10/16/2003	A report was received from a healthcare professional on 10/16/2003 concerning a 57 year old female vaccinee who received Fluvirin subcutaneously on 10/16/2003. On 10/16/2003 the vaccinee received Fluvirin subcutaneously.  No adverse event had occurred at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/16/2003	10/16/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300818	1						1	Medication error	FLU3~EVANS VACCINES~765146~2~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230294	12/09/2004			2	.3	M	10/08/2004	A report was received from a healthcare professional on 10/16/2003 concerning a 2 year old vaccinee of unknown sex who received Fluvirin on 10/16/2003. On 10/16/2003 the vaccinee received Fluvirin.  The vaccinee did not experience any adverse symptoms. There was insufficient information to determine the reporter's causality assessment. Update 2, 10 February 2004: Further information was received from a healthcare professional on 02/10/2004 indicating that the vaccinee was male and experienced no sequalae of any type in the six weeks post vaccination. No follow up pending, all information received.									U	10/16/2003	10/16/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300819	1						1	Medication error	FLU3~EVANS VACCINES~765799~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230295	12/09/2004					U	10/08/2004	A report was received from a health care professional on 10/17/03 concerning a group of vaccinees less than 4 years of age, of unknown sex who received Fluvirin on an unknown date. The reporter did not have vaccinee details or details of how many vaccinees were involved. At the time of the report there were no adverse events associated with Fluvirin. There was insufficient information to determine the reporter's causality assessment. Following up pending.									U					UNK	UNK	Concomitant Drug Not Reported		NO risk factors reported.		PJP200300821	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230296	12/09/2004		34.0	33		F	10/08/2004	A report was received from a healthcare professional on 10/17/2003 concerning a 33 year olf female vaccinee who experienced a reticular, blanching rash over the entire body on the same day as receiving Fluvirin on 10/16/2003. ON 10/16/2003 the vaccinee experienced a reticular, blanching rash over the entire body sparing only the face and the palms of the hands.  The vaccinee did not report any fever, shortness of breath or itch in relation to the rash.  It was the vaccinee's first exposure to the influenza vaccine.  The outcome of the event was not reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11/24/2003 Follow up information received from a healthcare professional indicated that the vaccinee also experienced epigastric pain and joint aches.  The event resolved on an unspecified dated. The reporter considered there to be a temporal relationship between the Fluvirin and the adverse events.									U	10/16/2003	10/16/2003	0		UNK	UNK	Depo Provera Paxil		No risk factors reported.		PJP200300822	1						1	Rash	FLU3~EVANS VACCINES~765712~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230297	12/09/2004		3.0			F		A report was received from a health care professional on 10/17/2003 concerning a 3 year old female vaccinee who received Fluvirin on 10/17/03 The vaccinee experienced no adverse symptoms. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1 11/14/2003: the follow up report received from a health care professional indicating that the vaccinee had not experienced any adverse events.									U					UNK	UNK	Concomitant Drug Not Reported.		No Risk Factors Reported		PJP200300823	1						1	Medication error	FLU3~EVANS VACCINES~765412~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230298	12/09/2004		63.0			F	10/08/2004	A report was received from a health care professional on 10/17/2003 concerning a 63 year old female vaccinee who experienced a red swollen rash on the same day as receiving expired Fluvirin on 10/15/2003. The rash was approximately 30 mm wide. The rash appeared to have stabilized on 10/16/2003. The out come was not reported. Update 1, 2/5/2004: A follow up report was received from a health care professional indicating that the vaccinee's red, swollen rash developed on 10/16/2003 and had completely resolved on 10/27/2003. The reporter assessed the causality as unrelated. No follow up pending all information received.									U	10/15/2003	10/15/2003	0		UNK	UNK	Concomitant Drug Not Reported		No Risk Factors Reported		PJP200300824	1						1	Rash erythematous; Swelling	FLU3~EVANS VACCINES~765795~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230299	12/09/2004		3.0			U	10/08/2004	A report was received from a health care professional on 10/17/2003 concerning a 3 year old vaccinee of unknown sex, who received Fluvirin on 10/17/2003. No Adverse event had occurred at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/17/2003	10/17/2003	0		UNK	UNK	Concomitant Drug Not Reported		No Risk Factors Reported		PJP200300825	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230300	12/09/2004		43.0			F	10/08/2004	A report was received from a health care professional on 10/17/2003 concerning an unspecified number of vaccinees of unspecified sex who received Fluvirin subcutaneously on an unspecified date. The vaccinees had not experienced any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 2/16/2004: A follow up report was received from a health care professional indicating that the 43 year old female vaccinee had no adverse event at the time of reporting. Follow up pending.									U					UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300826	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230301	12/09/2004					U	10/08/2004	A report was received from a health care professional concerning three vaccinees of unknown demography who experienced pain at the injection site an unspecified length of time after receiving Fluvirin vaccine on an unspecified day in October 2003. On an unspecified day in October 2003, three vaccinees experienced pain at the injection site that radiated up to the shoulder and neck after receiving Fluvirin.  The pain occurred on the same side of the body as the injection site. The outcome of the event was not reported. The reporter had administered approximately 80 Fluvirin injections to date this flu season. There was insufficient information to determine the reporter's causality assessment.  Update1, 11/10/2003: Further information received from a health care professional on 11/10/2003 indicated that 3 to 4 vaccinees experienced pain in their deltoid radiation into the trapezius 1 to 2 days after receiving Fluvirin on 10/03/03. No follow up pending. Cross reference with PJP-2003-00790.									U	10/03/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300827	1						1	Injection site pain; Pain	FLUX~UNKNOWN MANUFACTURER~765483~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0230302	12/09/2004		30.0	29		F	10/08/2004	A reported was received from a health care professional who was also the consumer on 10/20/2003 concerning a 29 year old female vaccinee who experienced a maculo-papular, non-itchy rash 2 days after receiving Fluvirin on 10/16/2003. On 10/18/2003 the vaccinee experienced a maculo-papular, non-itchy rash that began and was most concentrated in the abdominal area. By 10/19/2003 the rash had spread to the chest and arms. At the time of reporting the original site of the rash (upper abdoment) was unchanged and continued to spread. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update1, 03/01/2003: Follow up information received from a health care professional indicated that the maculo-papular, non-itchy rash was not due to the Fluvirin vaccination but was due to contact dermatitis with soap. No follow up pending.									U	10/16/2003	10/18/2003	2		UNK	UNK	Concomitant Drug Not Reported		No risk factor reported		PJP200300828	1						1	Dermatitis contact; Rash maculo-papular	FLU3~EVANS VACCINES~765138~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230303	12/09/2004		1.0			M	10/08/2004	A report was received from a health care professional on 10/20/2003, concerning an unknown number of children under 4 years of age who inadvertently received the Fluvirin vaccine on 10/15/2003. The reporter was uncertain how many children were vaccinated. At the time of th report no adverse events had occurred. There was insufficient information to determine the reporter's causality assessment. Update1, 11/25/2003: Follow up information received from a health care professional indicated that a 1 year old male vaccinee had been inadvertently administered a dose of Fluvirin instead of Fluzone between 10/06/2003 and 10/16/2003. No adverse event as reported at the time of report.									U					UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300830	1						1	Medication error	FLU3~EVANS VACCINES~765502~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230304	12/09/2004		54.0			F	10/08/2004	A report was received from a health care professional on 10/20/2003 concerning a 54 year old female vaccinee who experienced a red, hard, swollen area on day after receiving Fluvirin on 10/15/2003. On 10/16/2003, the vaccinee experienced a red, hard, swollen area about 2 inches in diameter after receiving Fluvirin on 10/15/2003. the event resolved after 2 days. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Reference: PJP-2003-00833, PJP-2003-00834, PJP-2003-00836									Y	10/15/2003	10/16/2003	1		UNK	UNK	Concomitant Drug Not Report		No risk factors reported		PJP200300832	1						1	Injection site erythema; Injection site induration; Injection site swelling	FLU3~EVANS VACCINES~765664~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230305	12/09/2004		57.0			F	10/08/2004	A report was received from a health care professional on 10/20/2003 concerning a 57 year old female vaccinee who experienced a red and swollen are on day after receiving Fluvirin on 10/15/2003. On 10/16/2003, the vaccinee experienced a red and swollen area about 3 inches in diameter after receiving Fluvirin on 10/15/2003. The outcome of the events were unknown at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Reference PJP-2003-00832, PJP-2003-00834, PJP-2003-00836.									U	10/15/2003	10/16/2003	1		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300833	1						1	Injection site erythema; Injection site swelling	FLU3~EVANS VACCINES~765664~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230306	12/09/2004		49.0			F	10/08/2004	A report was received from a health care professional on 10/20/2003 concerning a 49 year old female vaccinee who experienced redness and swelling on 10/13/2003 after receiving Fluvirin on the same day. The event was resolved at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Reference PJP -2003-00832, PJP-2003-00833, PJP-2003-00836									U	10/13/2003	10/13/2003	0		UNK	UNK	Concomitant Drug No Reported		No risk factors reported		PJP200300834	1						1	Erythema; Swelling	FLU3~EVANS VACCINES~765664~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230307	12/09/2004		52.0			F	10/16/2003	A report was received from a healthcare professional on 10/20/2003 concerning a 52 year old female vaccinee who experienced swelling and redness 2 days after receiving Fluvirin on 10/14/2003. On 10/16/2003, the vaccinee experienced swelling and redness after receiving Fluvirin on 10/14/2003.  At the time of the report the outcome of the event was unknown. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/14/2003	10/16/2003	2		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300836	1						1	Erythema; Swelling	FLU3~EVANS VACCINES~765664~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230308	12/09/2004		48.0	48		F	10/16/2003	A report was received from a healthcare professional who was also the consumer on 10/20/2003 concerning a 48 year old female vaccinee who experienced local erythema and pruritis minutes after receiving Fluvirin on 10/16/2003. On 10/16/2003 the vaccinee experienced local erythema and pruritis extending from the injection site to her left underarm to under her left breast.  The vaccinee self treated with oetrizine hydrochloride, diphenhydramine hydrochloride and prednisone.  The local reaction resolved within half an hour.  The outcome of the pruritis was not reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11/25/2003 Follow up information received from a healthcare professional indicated that the vaccinee experienced severe erythema and urticaria, localized to the left shoulder, left upper arm, left arm and left breast.  The event resolved on an unspecified date. The reporter has assessed the relationship of Fluvirin to the event as probably related.									Y	10/16/2003	10/16/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported. The vaccinee experienced a small injection site weal after influenza vaccination in 2003.  Anaphylactic allergy to latex.		PJP200300837	1						1	Injection site erythema; Pruritus	FLU3~EVANS VACCINES~~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230309	12/09/2004		69.0	68		F	10/08/2004	A report was received from a healthcare professional on 10/20/2003 concerning a 68 year old female vaccinee who received expired Fluvirin on 10/20/2003. On 20 October 2003 the vaccinee received expired Fluvirin.  The vaccinee did not complain of any adverse event. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1. 11/19/2003. A follow up report was received from a healthcare professional indicating that the vaccinee received 0.5ml of Fluvirin on 10/20/2003. No follow up pending.									U	10/20/2003	10/20/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300838	1						1	Medication error	FLU3~EVANS VACCINES~131902HA~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230310	12/09/2004		3.0	3		M	10/08/2004	A report was received from a healthcare professional on 10/20/2003 concerning an unspecified number of vaccinees less than 4 years of age who received Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received Fluvirin.  The reporter was not aware of any adverse symptoms occurring at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 11/10/2003: A follow up report was received from a healthcare professional indicating that a 3 year old male vaccinee received Fluvirin on 10/07/2003.									U	10/07/2003	10/07/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300839	1						1	Medication error	FLU3~EVANS VACCINES~765705~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230311	12/09/2004					M	10/08/2004	A report was received from a consumer on 10/20/2003 concerning a male vaccinee of unknown age who experienced tiredness, and felt achy 1 day after receiving expired Fluvirin on 10/19/2003. On 10/19/2003 the vaccinee believes he received expired Fluvirin.  On 10/20/2003 the vaccinee felt tired and achy. No follow up.  Permission not granted to contact physician. Update 1, 12 December 2003 A follow up report was received from a consumer indicating that the vaccine he received had not expired.  The reporter stated that Everything is OK'. Follow up pending.									U	10/19/2003	10/20/2003	1		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300841	1						1	Fatigue; Medication error; Pain	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230312	12/09/2004					F	10/08/2004	A report was received from a healthcare professional on 10/20/2003 concerning a female vaccinee in her 50's who experienced an injection site reaction with redness, pain, swelling, and itchiness 1 day after receiving Fluvirin on 10/17/2003. ON 10/18/2003 the vaccinee experienced an injection site reaction with redness, pain, swelling, and itchiness.  The swelling was 1.5cm by 1.5cm and the redness was 7cm by 7cm.  The vaccinee had not recovered at the time of the report.  There was insufficient information to determine the reporter's causality assessment. Update 1, 02 December 2003 Follow up information received from a healthcare professional indicated that the vaccinee who experienced severe swelling, redness and pain at the injection site, recovered within 1 week.									Y	10/17/2003	10/18/2003	1		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300842	1						1	Injection site erythema; Injection site pain; Injection site swelling; Pruritus	FLU3~EVANS VACCINES~765501~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230313	12/09/2004		46.0			F	10/11/2003	A report was received from a healthcare professional on 10/20/2003 concerning a 46 year old female vaccinee who experienced an injection site reaction with swelling, redness and pain 1 day after receiving Fluvirin on 10/10/2003. On 10/11/2003 the vaccinee experienced an injection site reaction with swelling, redness and pain.  The affected area was 5cm by 5cm.  The vaccinee recovered 1 week after onset. There was insufficient information to determine the reporter's causality assessment.   Follow up pending. Update 1, 02 December 2003: Follow up information received from a healthcare professional indicated that the vaccinee who experienced severe swelling, redness and pain at the injection site, recovered after 1 week.									Y	10/10/2003	10/11/2003	1		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300843	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~EVANS VACCINES~765501~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230314	12/09/2004					U	10/08/2004	A report was received from a health car professional on 10/20/03 concerning an unspecified number of vaccinees who experienced erythema at the injection site an unspecified length of time after receiving Fluvirin on an unspecified date. There was insufficent information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300844	1						1	Injection site erythema	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230315	12/09/2004		47.0	46		M	10/08/2004	A report was received from a health care professional who was also the consumer on 10/21/2003 concerning a 46 year old male vaccinee who experienced swelling and discomfort  at the lymphatics 6 days after receiving Fluvirin on 10/14/2003. On 10/20/03 the vaccinee began to experience swelling and discomfort at the lympatics located at the left anterior axilla that also involved the left breast. The vaccine in the left deltoid. The out come of the event was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 10/29/2003: A follow up was received from the effected and reporting health care professional indiciating that the lymphadenopathy under the axilla had slightly decreased. Swelling at the breast persists. Additionally the reporter reports pleuritic chest pain which has worsened and describes the pain like a costochondritis. A chest X-ray was performed on 10/28/2003 to rule out causes of chest pain. Update 2, 11/14/2003: Internal review indicated that these reactions were medically significant. Update 3, 11/17/2003: Further internal medical review indicated that  these reactions were not medically significant. Update 4, 12/22/2003: Follow up information received from the health care professional inidicated that the adverse events began on 10/21/03. The axillary lymph nodes clinically resolved three and a half weeks later. However the pleuritic chest pain remains on going with slight improvement. The health care professional has assessed the relationship of the vaccine to the lymphadenopathy as probable.									U	10/14/2003	10/21/2003	7	10/28/2003 Chest X-ray to rule out causes of chest pain	UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300848	1						1	Chest pain; Lymphadenitis; Lymphadenopathy; Mastitis; Pleuritic pain	FLU3~EVANS VACCINES~765497~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230316	12/09/2004		41.0	41		F	10/08/2004	A report was received from a health care professional on 10/21/03 concerning a 41 year old female vaccinee who experience nausea 6.5 hours after, and vomiting on day after receiving Fluvirin on 10/20/03. On 10/20/2003 the vaccinee experienced nausea 6.5 hours after vaccination. The nausea lasted until the following morning, during which time the vaccinee vomited every half hour up to a total of 6 to 8 times. The vaccinee claims to have an allergy to eggs and the last time she was exposed to eggs she experienced diarrhea, blotchy red rash, nausea and vomiting. The vaccinee was still nauseated at the time of the report and was to see her physician for treatment. There was insufficient information to determine the reporter's causality assessment.  Update 1, 11/27/2003: Follow up information received from a health care professional indicated that following treatment with diphenhydramine hydrochloride the nausea and vomiting resolved.									Y	10/20/2003	10/20/2003	0		UNK	UNK	Bextra 10 mg Lasix 20mg Norco  Oxycontin 40mg		No risk factors reported. Allergy to eggs.		PJP200300849	1						1	Nausea; Vomiting	FLU3~EVANS VACCINES~765137~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230317	12/09/2004					U	10/08/2004	A report was received from a health care professional on 10/21/2003 concerning a vaccinee of unknown demography who was administered Fluvirin by an unlicensed route on 10/20 or 10/21/2003. On 10/20 or 10/21/2003, the vaccinee received one dose of fluvirin vaccine in the gluteal muscle instead of the deltoid muscle. At the time of the report the vaccinee had not experienced any adverse reaction. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	Concomitant Drug Not Reported		No risks factors reported		PJP200300850	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~GM~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230318	12/09/2004		66.0			M	10/08/2004	A report was received from a health care professional on 21 October 2003 concerning a 66-year-old male vaccinee who received an accidental overdose of Fluvirin on 21 October 2003. On 21 October 2003 the vaccinee received 0.5ml Fluvirin in each deltoid. No adverse symptoms were observed. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 14 November 2003: A follow up report was received form a health care professional indicating that the vaccinee was checked on 7 November 2003 and had experienced no adverse event.									Y	10/21/2003	10/21/2003	0		UNK	UNK					PJP200300851	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~765416~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230319	12/09/2004		3.0			U	10/08/2004	A report was received from a health care professional on 21 October 2003 concerning a 3-year-old vaccinee who received Fluvirin on 20 October 2003. On 20 October 2003 the 3 year-old vaccinee inadvertently received Fluvirin. No adverse symptoms were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/20/2003	10/20/2003	0		UNK	UNK					PJP200300852	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230320	12/09/2004					F	10/08/2004	A report was received from a health care professional on 21 October 2003 concerning a female vaccinee of unknown age who inadvertently received Fluvirin subcutaneously on 21 October 2003. On 20 October 2003 the vaccinee inadvertently received Fluvirin subcutaneously. No adverse symptoms were reported in association with the event. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									Y	10/21/2003	10/21/2003	0		UNK	UNK					PJP200300853	1						1	Medication error	FLU3~EVANS VACCINES~765712~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230321	12/09/2004					U	10/08/2004	A report was received from a consumer on 21 October 2003 concerning a vaccinee of unknown demography who received 3ml of Fluvirin on 20 October 2003. On 20 October 2003 the vaccinee received 3ml of Fluvirin. The vaccinee denied experiencing any adverse symptoms at the time of the report. No follow-up. Permission not granted to contact physician.									Y	10/20/2003	10/20/2003	0		UNK	UNK					PJP200300854	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230322	12/09/2004		4.0	3		M	10/08/2004	A report was received from a health care professional on 21 October 2003 concerning a 3-year-old vaccinee who received Fluvirin on 21 October 2003. On 21 October 2003 the vaccinee received 0.5ml Fluvirin. No adverse symptoms were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment.									U	10/21/2003	10/21/2003	0		UNK	UNK					PJP200300855	1						1	Medication error	FLU3~EVANS VACCINES~765415~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230323	12/09/2004		87.0			F	10/08/2004	A report was received from a health care professional on 21 October 2003 concerning a vaccinee of unknown demography who received expired Fluvirin on 20 October 2003. On 20 October 2003 the vaccinee received expired Fluvirin. No adverse symptoms were reported at the time of the event. There was insufficient information to determine the report's causality assessment. Update 1, 24 November 2003: Follow up information received from a health care professional indicated that the 87 year old female vaccinee did not experience any adverse reaction. The reporter stated that the vaccinee will receive the 2003-2004 vaccine in January 2004.									Y	10/20/2003	10/20/2003	0		UNK	UNK	Antibioplastic agents, Synthroid, Zinc, Calcium, Vitamin D, Relapen, and Ambien.		Apparent advanced stage ovarian cancer May 2003.		PJP200300856	1						1	Medication error	FLU3~EVANS VACCINES~E33482HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230324	12/09/2004		67.0	66		F	10/08/2004	A report was received from a health care professional on 21 October 2003 concerning a 66-year-old female vaccinee who experienced breathing difficulty and chills 3 days after receiving Fluvirin on 17 October 2003. On 20 October 2003 the vaccinee experienced breathing difficulty and chills. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									N	10/17/2003	10/20/2003	3		UNK	UNK	NONE		Allergy to sulfa		PJP200300857	1						1	Chills; Dyspnoea	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230325	12/09/2004		65.0			M	10/08/2004	A report was received from a health care professional on 22 October 2003 concerning a 65-year-old male vaccinee who experienced shortness of breath, dizziness, nausea and blurred vision 1 hour after receiving Fluvirin on 22 October 2003. On 22 October 2003 the vaccinee experienced shortness of breath, dizziness, nausea, and blurred vision. The vaccinee was taken to an emergency room for the management of events. It was unknown at the time of the report whether or not the vaccinee was admitted to hospital. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 10 December 2003: Following medical review on 10 December 2003, this case was considered to be medically significant (OMIC).				Y					U	10/22/2003	10/22/2003	0		UNK	UNK					PJP200300860	1						1	Dizziness; Dyspnoea; Nausea; Vision blurred	FLU3~EVANS VACCINES~765854~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0230326	12/09/2004					U	10/08/2004	A report was received by a health care professional on 22 October 2003 concerning 80 adult vaccinees who received Fluvirin subcutaneously. A 27 gauge half-inch needle was used. Non of the vaccinees exhibited any adverse symptoms. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									Y	10/21/2003	10/21/2003	0		UNK	UNK					PJP200300861	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230327	12/09/2004					U	10/08/2004	A report was received from a health care professional 22 October 2003 concerning a vaccinee of unknown demography who received two doses of Fluvirin on an unspecified date. On an unspecified date the vaccinee received two doses of Fluvirin. The reporter did not know if the vaccinee had experienced any adverse symptoms or if the vaccinee was given in a single 1ml dose or two 0.5ml doses. There was insufficient information to determine the reporter's causality assessment. Update1, 17 November 2003: Follow-up information received from a health care professional indicated that the vaccinee inadvertently received 1 dose of Fluvirin subcutaneously on 03 October 2003. The vaccinee was monitored adverse effects but none were reported.									Y		10/03/2003			UNK	UNK					PJP200300862	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~765875~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230328	12/09/2004		3.0	2	.9	U	10/08/2004	A report was received from a health care professional on 22OCT2003 concerning a 2 year old male vaccinee who inadvertently received Fluvirin on 21OCT2003. On 21OCT2003 the 2 year old vaccinee received Fluvirin . The vaccinee did not exhibit any adverse reaction as a result. There was insufficient information to determine the reporter's causality assessment. Update 1 12NOV2003: follow up information received from a health care professional indicated that the vaccinee experienced no adverse reaction.									Y	10/21/2003	10/21/2003	0		UNK	UNK					PJP200300863	1						1	Medication error	FLU3~EVANS VACCINES~765851~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230329	12/09/2004		24.0	23		M	10/08/2004	A report was received from a health care professional on 22OCT2003, concerning a 23 year old male vaccinee who experienced hives on his abdomen, thighs and arms and a red, swollen and hot injection site two days after receiving the Fluvirin vaccine on 20OCT2003. On 22OCT2003, the vaccinee woke up with hives on his abdomen, thighs and arms. His Fluvirin injection site was red, swollen and hot to touch. Following administration of Diphenhydramine the hives improved slightly. Update 1, 16FEB2004. A follow up report was received from a health care professional indicating that the 24 year old vaccinee's hives have now resolved. The vaccinee is allergic to sulphonamindes drugs and had mixed Amoxicillin Suspension the night prior to the development of the hives. The hives were persistent and re-flared for one week. The vaccinee was treated with prednisone and cetirizine hydrochloride. The reporter has assessed the relationship of Fluvirin to the event as probable. No follow up pending, all information received.									U	10/20/2003	10/22/2003	2		UNK	UNK	Factor VIII		Hemophilia since birth, Allergic to sulphonamides		PJP200300864	1						1	Injection site erythema; Injection site swelling; Injection site warmth; Urticaria	FLU3~EVANS VACCINES~765499~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230330	12/09/2004		3.0			M	10/08/2004	A report was received from a health care professional on 22OCT2003 concerning a 3 year old male vaccinee who received Fluvirin on 22OCT2003. On 22OCT2003 the three year old vaccinee received Fluvirin. The vaccinee had not experienced any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update report: 1DEC2003. Follow up information received from a health care professional indicated that the vaccinee received Fluvirin on 21OCT2003 and not on 22OCT2003 as was previously stated. No follow up pending,all information received.									Y	10/21/2003	10/21/2003	0		UNK	UNK					PJP200300865	1						1	Unevaluable event	FLU3~EVANS VACCINES~765799~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230331	12/09/2004		0.79	0	.8	F	10/08/2004	A report was received from a health care professional on 22OCT2003 concerning a 9 month old female vaccinee who received Fluvirin on 22OCT2003. On 22OCT2003 the 9 month old vaccinee received Fluvirin. The vaccinee had not experienced any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1 17NOV2003: Follow up information received from a health care professional indicated that the vaccinee did not experience any adverse effects.									U	10/22/2003	10/22/2003	0		UNK	UNK					PJP200300866	1						1	Unevaluable event	FLU3~EVANS VACCINES~765143~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230332	12/09/2004		57.0			M	10/08/2004	A report was received from a health care professional on 22OCT2003 concerning a 57 year old male vaccinee who experienced low grade temperature, general body aches, joint pains and mild diarrhea 12 hours after receiving Fluvirin on 20OCT2003. On an unspecified date, 12 hours after receiving Fluvirin in OCT 2003 the vaccinee experienced low grade temperature, general body aches, joint pains and mild diarrhea. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending . Cross reference with PJP200300868.									U	10/20/2003				UNK	UNK			Chronic obstructive pulmonary disease		PJP200300867	1						1	Arthralgia; Diarrhoea; Pain; Pyrexia	FLU3~EVANS VACCINES~765670~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230333	12/09/2004		45.0			M	10/08/2004	A report was received from a health care professional on 22OCT2003 concerning a 45 year old male vaccinee who experienced low grade temperature and general body aches 12 hours after receiving Fluvirin on 17OCT2003. On an unspecified date , 12 hours after receiving Fluvirin, the vaccinee experienced low grade temperature and general body aches. The vaccinee recovered 12 hours later. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with PJP200300876.									U	10/17/2003				UNK	UNK					PJP200300868	1						1	Pain; Pyrexia	FLU3~EVANS VACCINES~765670~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230334	12/09/2004		61.0	61		F	10/08/2004	A report was received from a health care professional on 22OCT2003 concerning a 61 year old female vaccinee who developed a protruding , pin pong ball sized swelling immediately after receiving Fluvirin vaccine on 8OCT2003. On 8OCT2003, the vaccinee developed a protruding, ping pong ball sized swelling immediately after receiving Fluvirin vaccine. The reporter stated that the adverse event is most likely resolved. There was insufficient information to determine the investigator's causality assessment. Reference: PJP200300870, PJP200301318.									U	10/08/2003	10/08/2003	0		UNK	UNK					PJP200300869	1						1	Swelling	FLU3~EVANS VACCINES~765664~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230335	12/09/2004		70.0	69		F	10/08/2004	A report was received from a health care professional on 22OCT2003 concerning a 69 year old female vaccine who developed a protruding, ping pong ball sized swelling immediately after receiving Fluvirin vaccine on 14OCT2003. On 14OCT2003, the vaccinee developed a protruding , ping pong ball sized swelling immediately after receiving Fluvirin vaccine. The reporter stated that the adverse event is most likely resolved. There was insufficient information to determine the investigator's causality assessment. Reference : PJP200300869, PJP200301318.									Y	10/14/2003	10/14/2003	0		UNK	UNK			Allergy to meclofenamate		PJP200300870	1						1	Swelling	FLU3~EVANS VACCINES~765664~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230336	12/09/2004		32.0	31		F	10/08/2004	A report was received from a health care professional on 22OCT2003 concerning a 30 year old female vaccinee who experienced redness and swelling at the site of injection one day after receiving Fluvirin on 20OCT2003. On 21OCT2003 the vaccinee experienced redness and swelling at the injection site. The swelling was also reported to be warm to the touch. The vaccinee had not recovered at the time of the report. The was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1 10NOV2003: A follow up report was received from a health care professional indicating that a 31 year old female vaccinee experienced a 50 cents size red sore local reaction one day after receiving Fluvirin on 21OCT2003. The vaccinee recovered on 25OCT2003.									U	10/21/2003	10/22/2003	1		UNK	UNK					PJP200300871	1						1	Injection site erythema; Injection site swelling	FLU3~EVANS VACCINES~765181~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230337	12/09/2004		33.0	32		F	10/08/2004	A report was received from a health care professional on 22OCT2003 concerning a 30 year old female vaccinee who experienced injection site swelling and redness on an unspecified length of time after receiving Fluvirin on 17OCT2003. On an unspecified date in OCT2003 the vaccinee experienced injection site swelling and redness. The swelling was also reported to be warm to touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1 , 10NOV2003: A follow up report was received from a health care professional indicating that the reaction was the size of a 50 cents piece. The vaccine was administered on 16OCT2003 as previously reported. The onset date was reported as 17OCT2003. The vaccinee was 32 years old and not 30 years old as previously reported. The vaccinee recovered on 20OCT2003. Cross reference with PJP200300871.									U	10/16/2003	10/17/2003	1		UNK	UNK					PJP200300872	1						1	Feeling hot; Injection site erythema; Injection site swelling	FLU3~EVANS VACCINES~765181~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230338	12/09/2004		41.0	41		F	10/08/2004	A report was received from a health care professional on 22OCT2003 concerning a 41 year old female vaccinee who experiened tenderness, swelling and hardness at the site of injection approximately 1 to 2 hours after receiving Fluvirin SC on 21OCT2003. On 21OCT2003 the vaccinee received Fluvirin SC, 1-2 hours after receiving Fluvirin the vaccinee experienced some tenderness , swelling and hardness at the site of injection. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 3FEB2004: Further information was received from a health care professional on 3FEB2004 indicating that the vaccinee experienced local pain, swelling and redness 2-3 days following vaccination . The local pain, swelling and redness lasted 1.5 months. There was no further sequelae. Follow up pending. Cross reference with PJP200300874.									U	10/21/2003	10/21/2003	0		UNK	UNK			Allergy to aspirin, ampicillin, cefazolin sodium		PJP200300873	1						1	Erythema; Injection site induration; Injection site swelling; Pain; Tenderness	FLU3~EVANS VACCINES~~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230339	12/09/2004		45.0	44		F	10/08/2004	A report was received from a health care professional on 22OCT2003 concerning a 45 year old female vaccinee who experienced tenderness at the site of injection an unspecified length of time after receiving Fluvirin SC on 21OCT2003. On 21OCT2003 the vaccinee received Fluvirin SC. An unspecified length of time after receiving Fluvirin the vaccinee experienced some tenderness at the site of injection. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 3FEB2004: Further information was received from a health care professional on 3FEB2004 indicating that the vaccinee also experienced local pain which started 2 days following vaccination. The local pain lasted for 2-3 days and the vaccinee is reported to be doing well. Cross reference with PJP200300873.									U	10/21/2003	10/21/2003	0		UNK	UNK					PJP200300874	1						1	Injection site reaction; Pain; Tenderness	FLU3~EVANS VACCINES~765852~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230340	12/09/2004		3.0	2	.8	M	10/08/2004	A report was received from an office manager on 20OCT2003 and validated by a health care professional on 21OCT2003 concerning a 2 year old male vaccinee who received Fluvirin on 20OCT2003. On 20OCT2003 the two year old vaccinee received Fluvirin. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/20/2003	10/20/2003	0		UNK	UNK					PJP200300875	1						1	Unevaluable event	FLU3~EVANS VACCINES~765795~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230341	12/09/2004					U	10/08/2004	A report was received form a health care professional on 23OCT2003 concerning a vaccinee less than 4 years of age who received Fluvirin on 22OCT2003. On 22OCT2003 the vaccinee received Fluvirin wen less than 4 years of age. The reporter did not know whether or not the vaccinee exhibited any signs or symptoms of an adverse reaction. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/22/2003	10/22/2003	0		UNK	UNK					PJP200300878	1						1	Unevaluable event	FLU3~EVANS VACCINES~765712~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230342	12/09/2004		3.0	2	.7	M	10/08/2004	A report was received from a health care professional on 10/23/2003 concerning approximately 10 pediatric vaccinees less than 4 years old, of unknown sex, who were inadvertently administered Flurvirin vaccine between 10/08/03 and approximately 10/22/03. No adverse reactions were recorded at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/9/2003: A follow up report was received from a health care professional indicating that a 2 year old male vaccinee inadvertently received Fluvirin on 10/15/2003. On 10/15/2003 a 2 year old vaccinee inadvertently received 0.25ml Fluvirin. At the time of reporting the vaccinee did not exhibit any adverse symptoms. Cross reference with: PJP-2003-01263, PJP-2003-01264, PJP-2003-1265, PJP-2003-01266, PJP-2003-01267, PJP-2003-01268, PJP-2003-01269. No follow up pending. A information received.									U	10/15/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300879	1						1	Medication error	FLU3~EVANS VACCINES~765703~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230343	12/09/2004					U	10/08/2004	A report was received from a health care professional on 10/23/2003 concerning 6 pediatric vaccinees less than 4 years old, of unknown sex, who were inadvertently administered Fluvirin vaccine from 10/13/2003 until approximately 10/23/2003. It was unknown if there were any adverse events associated with the inadvertent administrations. There was insufficient information to determine the reporter's causality assessment. Update 1, 2/13/04: A follow up report was received from a health care professional indicating that 2 vaccinees under 4 years of age inadvertently received Fluvirin. The reporter was unaware of any adverse events at the time of reporting. No follow up pending, all information received.									U					UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300880	1						1	Medication error	FLU3~EVANS VACCINES~765876~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230344	12/09/2004					M	10/08/2004	A report was received from a consumer on 10/23/2003 concerning a male vaccinee of unspecified age who believes he received half the recommended dosage of Fluvirin on an unspecified date. The vaccinee indicated that while the nurse was administering Fluvirin, he saw a bubble in the syringe and the amount in the syringe was 0.25ml. The vaccinee did not report any adverse events in association with the incident. No follow up. The reporter declined to give permission to contact his physician.									U					UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300881	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230345	12/09/2004					U	10/08/2004	A report was received from a health care professional on 10/23/2003 concerning 39 adult vaccinees of unknown gender who inadvertently received Fluvirin subcutaneously on 10/23/03. On 10/23/2003, 39 adult vaccinees inadvertently received Fluvirin subcutaneously with a 26 gauge half inch needle. No vaccinees had exhibited any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. No follow up. The reporter declined to provide any further information.									U					UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300882	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230346	12/09/2004		0.84	0	.8	F	10/08/2004	A report was received from a health care professional on 10/22/2003 concerning a 22 month old female vaccinee who inadvertently received Fluvirin on 10/15/2003. The vaccinee did not exhibit any signs or symptoms of an adverse reaction at the time of the report. There was insufficent information to determine the reporter's Causality assessment. Update 1, 11/27/2003: Follow up information was received from a health care professional on 11/27/2003 indicating that the vaccinee was 10 months old. No sequela was noted at the time of the report. No follow up pending. Cross reference with PJP-2003-00913.									U	10/15/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200300883	1						1	Medication error	FLU3~EVANS VACCINES~765501~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230347	12/09/2004		57.0	56		M	10/08/2004	A report was received from a health care professional on 10/23/2003 concerning a 56 year old male vaccinee who inadvertently received 2 doses of Fluvirin on 10/22/2003. On 10/22/2003 the vaccinee inadvertently received 2 doses of Fluvirin, one in each deltoid. It was unknown at the time of the report whether or not the vaccinee had experienced an adverse event. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update report, 1/19/2004: Follow up information received from a health care professional indicated the vaccinee did not experience any adverse event following inadvertent administration of Fluvirin.  No follow up pending, all information received.									U	10/22/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300884	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~765409~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230348	12/09/2004		0.7			F	10/08/2004	A report was received from a healthcare professional on 10/23/2003 concerning an 8 month old female vaccinee who inadvertently received Fluvirin on 10/07/2003.On 10/07/2003 the vaccinee who was less than 4 years of age inadvertently received Fluvirin. No adverse event had occurred at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/07/2003	10/07/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300885	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230349	12/09/2004		2.0	2	.3	F	10/08/2004	A report was received from a healthcare professional on 10/23/2003, concerning a 2 year old female vaccinee who inadvertently received the Fluvirin vaccine on 10/14/2003. On 10/14/2003 the vaccinee inadvertently received the Fluvirin vaccination.  At the time of the report no adverse event had occurred. There was insufficient information to determine the reporter's causality assessment. Update 1, 16 March 2004: Further information was received from a healthcare professional indicating that the vaccinee experienced no adverse events.									U	10/14/2003	10/14/2003	0		UNK	UNK	Albuterol  Pulmozyme Prevacid Pancrecarb		No risk factors reported. Cystic Fibrosis		PJP200300886	1						1	Medication error	FLU3~EVANS VACCINES~765753~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230351	12/09/2004		35.0			F	10/08/2004	A report was received from a healthcare professional on 10/24/2003 concerning 4 vaccinees of unspecified demography who experienced redness and wheals at the injection site with itching on the same day as receiving Fluvirin on 10/24/2003. On 10/24/2003 the vaccinees experienced redness and wheals at the injection site with itching.  The vaccinees recovered on 10/24/2003. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 11/17/2003: A follow up report was received indicating that a 35 year old female vaccinee experienced a large red wheal with redness, swelling and warmth within 20 minutes of receiving Fluvirin on 10/22/2003.  The vaccinee was treated with antihistamines.  The vaccinee recovered on 10/25/2003.									Y	10/22/2003	10/22/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300888	1						1	Feeling hot; Injection site erythema; Injection site reaction; Pruritus; Swelling; Urticaria	FLU3~EVANS VACCINES~765874~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230352	12/09/2004		2.0	2	.4	M	10/08/2004	A report was received from a healthcare professional on 10/24/2003 concerning 3 vaccinees of unknown gender less than 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date 3 vaccinees less than 4 years of age inadvertently received Fluvirin.  It was unknown at the time of the report whether or not the vaccinees had exhibited any signs or symptoms of an adverse reaction. There was insufficient information to determine the reporter's causality assessment. Update 1, 11/24/2003: Follow up information was received from a healthcare professional on 11/24/2003 indicating that the vaccinee was a 2 year old male.  The vaccinee experienced local redness at the site of injection an unspecified length of time after receiving 0.25ml Fluvirin on 10/17/2003.  The vaccinee also experienced fever, local swelling, bruising, soreness and redness on 10/18/2003.  The fever lasted for 2 days.  The local swelling, bruising, soreness and redness resolved 1 week later. Follow up pending.									Y	10/17/2003	10/17/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300889	1						1	Contusion; Injection site erythema; Injection site pain; Medication error; Pyrexia; Swelling	FLU3~EVANS VACCINES~765878~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230353	12/09/2004		0.5	0	.5	F	10/08/2004	A report was received from a health care professional on 24 October 2003 concerning 3 vacciness of unknown gender less than 4 years of age who inadvertentl received Fluvirin on an unspecified date. On an unspecified date, 3 vacciness less than 4 years of age inadvertently received Fluvirin.  It was unknown at the time of the report whether or not the vacciness had exhibited my signs or symptoms of an adverse reaction. There was insufficiant information to determine the reporter's causality assesment. Update 1, 24 November 2003: Follow up information was received from a health care professional on 24 November 2003 indicating that the vaccinee was a 6 month old female. the vaccinee experienced fever on 23 October 2003 after receiving 0.25 ml Fluvirin vaccine on 22 October 2003. The fever resolved 2 days later. Follow up pending. Cross reference with: PJP200300889,PJP200301210, PJP200301211, PJP200301212, PJP200301213.									U	10/22/2003	10/22/2003	0		UNK	UNK					PJP200300890	1						1	Medication error; Pyrexia	FLU3~EVANS VACCINES~765878~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230354	12/09/2004		48.0			F	10/08/2004	ADMINISTRATION BY UNLICENSED ROUTE (MEDICATION ERROR, MEDICATION ERROR) (MED ERROR) - Not Reported SWELLING AT THE SITE OF INJECTION (INJECTION SITE EDEMA, INJECTION SITE EDEMA) (EDEMA INJECTSITE) - recovered/resolved discoloration at the injection site (injection site reaction, injection site reaction ) (inject site react ) - recovered/ resolved INDURATION AT THE SITE OF INJECTION (INJECTION ISTE REACTION, INJECTION SITE REACTION ) (INJECT SITE REACT ) - recovered/ resolved  A report was received from a health care professional on 24 October 2003 concerning a 48 year old female vaccine who experienced swelling a discoloration at the site of injection an unspecified length of time after inadvertently receiving Fluvirin by subcutaneous injection on 24 October 2003.  On 24 October 203 the vaccine received Fluvirin by subcutaneous injection.  An unspecified length of time after receiving fluvirin the vaccine experienced swelling and discoloration at the injection site.  The outcome of the event was not reported. There was insufficient information to determine the reporter's causality assessment.  Update 1, 12 January 2004.  A follow up letter was received from  a health care professional indication that the swelling and in duration at the site of injection began on 24 October 2003 and had completely subsided after 3 days.  No residual effects were noted accourding to the reporter.  No follow up pending, all information received.									U					UNK	UNK					PJP200300891	1						1	Injection site swelling; Skin discolouration	FLU3~EVANS VACCINES~765952~UNK~ID~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230355	12/09/2004		65.0			M	10/08/2004	A report was received from a health care professional on 27 October 2003 concerning a 72 year old male vaccine who received a dose of Fluvirin vaccine on 13 October 2003 and inadvertently received a second dose on 27 October 2003. On 13 October 2003, the vaccine was administered Fluvirin and he inadvertently received a second dose of Fluvirin and he inadvertently received a second dose of fluvirin two weeks later on 27 October 2003.  No adverse events were reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 01 December 2003: Follow up information was received from a health care professional on 01 December 2003 indicating the vaccine was 65 years old. No follow up pending.									U		10/27/2003			UNK	UNK					PJP200300893	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~765665~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230356	12/09/2004					M	10/08/2004	VACCINE RECEIVED 2 DOSES (ACCIDENTAL OVERDOSE, ACCIDENTAL OVERDOSE) (OVERDOSE ACCID) - Not reported  A report was received from a health care professional on 27 October 2003 concerning a vaccine of unknown demography who received 2 doses of Fluvirin vaccine 2 weeks apart on unknown dates.  On unknown dates, the vaccine received 2 doses of Fluvirin 2 weeks apart.  The outcome was not reported.  There was insufficient information to determine the reporter's causality assessments.  Update 1, 01 December 2003: Further information received from a health care professional on 01 December 2003 indicated theat the vaccine was male and received Fluvirin intramiscularly.  Follow up pending.									U					UNK	UNK					PJP200300894	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230357	12/09/2004		36.0	36		F	10/08/2004	A report was received from a health care professional on 10/27/2003 concerning a 36 year old female vaccinee who inadvertently received expired Fluvirin vaccine on 10/27/2003. On 10/27/03, the vaccinee was inadvertently administered Fluvirin vaccine for the 2002-2003 flu season.  The vaccinee received 0.5 ml fluvirin intramuscularly in her deltoid. No adverse events were reported. There was insufficient information to determine the reporter's causality assessment. Update report, 1/13/04: Follow up information received from a health care professional indicated the Fluvirin vaccine administered on 10/27/03 had not expired. The vaccinee did not experince any adverse reaction following administration. Follow up pending.									U	10/27/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200300895	1						1	Medication error	FLU3~EVANS VACCINES~E35492KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230358	12/09/2004		3.0	3		M	10/08/2004	A report was received from a health care professional on 27 October 2003 concerning a 3 year old male vaccinee who inadvertently received Fluvirin vaccine on 21 October 2003. On 21 October 2003, the vaccinee was inadvertently administered Fluvirin. No adverse event was reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									Y	10/21/2003	10/21/2003	0		UNK	UNK					PJP200300896	1						1	Medication error	FLU3~EVANS VACCINES~765873~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230359	12/09/2004					U	10/08/2004	A report was received from a health care professional on 27 October 2003 concerning a vaccinee of unknown demography who experienced a red, hot arm with a rash, neck redness and difficulty breathing an unspecified length of time after receiving Fluvirin vaccine on an unknown date. On an unknown date, the vaccinee's arm became red and hot with a rash. The redness extended from the arm to the vaccinee's neck. The vaccinee also experienced difficulty in breathing. The outcome of the events was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with PJP-2003-01009.									U					UNK	UNK					PJP200300897	1						1	Dyspnoea; Erythema; Feeling hot; Rash	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230360	12/09/2004		57.0	57		F	10/08/2004	A report was received from a health care professional on 27 October 2003 concerning a 57 year old female vaccinee who experienced fever, myalgia, a sore throat and shortness of breath on 24 October 2003 and swollen glands, headache, fever and hallucinations one day later, and elevated blood pressure and a temperature of 100 degrees Fahrenheit three days later after receiving Fluvirin vaccine on 24 October 2003. On 24 October 2003 in the evening, the vaccinee developed fever, myalgia, a sore throat and shortness of breath. On 25 October 2003 the vaccinee experienced hallucinations and continued to have muscle aches, swollen glands, headache and fever for which the vaccinee did not seek medical care. On 27 October 2003, the vaccinee attended her doctor's office with a temperature of 100 degrees Fahrenheit, and continuing headache, myalgia and had an elevated blood pressure of 160/90 mmHg. the outcome of the events was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1: 05 December 2003. Follow-up information received from a health care professional on 05 December 2003 indicated that the vaccinee received Pneumovax on the same day the Fluvirin was administered. The adverse events occurred 10 hours after administration of Fluvirin and Pneumovax on the same day and experienced no adverse events. The vaccinee recovered on 27 October 2003 following treatment with methylprednisone dose pack. The reporter has assessed the relationship of the Fluvirin to the fever, myalgia, sore throat, swollen glands, headache, hallucinations, elevated blood pressure and nausea as probable. Follow-up pending.									Y	10/24/2003	10/24/2003	0		UNK	UNK	Atenolol, K-Dur, Neurontin, Effexor		Progressive peripheral neuropathy and Charcot-Marie-Tooth disease		PJP200300898	1						1	Blood pressure increased; Dyspnoea; Hallucination; Headache; Lymphadenopathy; Myalgia; Nausea; Pharyngolaryngeal pain; Pyrexia	FLU3~EVANS VACCINES~765180~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0230361	12/09/2004					F	10/08/2004	A report was received from a health care professional on 27 October 2003 concerning a female vaccinee of unknown age who inadvertently received a partial dose of Fluvirin vaccine on 27 October 2003. On 27 October 2003, the vaccinee inadvertently received a partial dose of Fluvirin as the needle became loose from the syringe. No adverse event was reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/27/2003	10/27/2003	0		UNK	UNK					PJP200300899	1						1	Medication error	FLU3~EVANS VACCINES~765876~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230362	12/09/2004					U	10/08/2004	A report was received from a health care professional on 27 October 2003 concerning approximately 100 vaccinees who inadvertently received Fluvirin vaccine subcutaneously during the week of 20 October 2003. During the week of 20 October 2003, approximately 100 vaccinees were administered Fluvirin subcutaneously. No adverse effects were reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/20/2003	10/20/2003	0		UNK	UNK					PJP200300900	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230363	12/09/2004		68.0	68		F	10/08/2004	A report was received by a health care professional on 27 October 2003, concerning a vaccinee of unknown demography who experienced hives and total body itching on the same day as receiving Fluvirin on 16 October 2003. on 16 October 2003 the vaccinee experienced hives and total body itching. the symptoms had not resolved at the time of the report, so the vaccinee's physician planned to treat the symptoms with unspecified corticosteroid therapy. Update 1, 09 Feb 2004. A follow-up report was received from a health care professional concerning a 68 year old female vaccinee who developed a rash and intense itching on an unreported area the same evening as she received Fluvirin in her left deltoid on 15 October 2004. The rash appeared the following day on the left deltoid. A biopsy from this site was reported as probable urticarial reaction. The reporter reported this as possibly related to drug reaction. At the time of the follow-up report the vaccinee's itching had resolved, but the rash had not resolved. The vaccinee was treated with oral prednisone. The reporter assessed the causality of the rash as probably related to Fluvirin, and the causality of the itching also probably related to Fluvirin. Update 2, 15 March 2004: Further information received from a health care professional indicated that the vaccinee's rash and itching have now become a chronic problem. The vaccinee is now under the care of an allergist who reports that the vaccinee's symptoms were probably not from the flu injection. The vaccinee has commenced treatment with allergy medication and continues to use topical steroids. Update 3, 19 April 2004: A follow-up report was received from a health care professional indicating that the vaccinee continues to have rashes and itching which was diagnosed as allergies and eczema. The vaccinee continues to have treatment and is currently on unspecified oral antihistamines and unspecified topical steroids. The vaccinee was reported to have a history of eczema and an unspecified allergy. Follow up pending.				Y					U	10/16/2003	10/16/2003	0		UNK	UNK	Altace, Dextrol LA, Calcium		Hypertension, Calcium Deficiency, Eczema and an unspecified allergy		PJP200300901	1						1	Eczema; Hypersensitivity; Pruritus; Rash; Urticaria	FLU3~EVANS VACCINES~765146~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0230364	12/09/2004		41.0			F	10/08/2004	A report was received from a health care professional who was also the consumer on 27 October 2003 concerning a 41 year old female vaccinee who received 1.5 milliliters of Fluvirin on 27 October 2003. On 27 October 2003 the vaccinee self administered 1.5 milliliters. No adverse effects were noted at the time of the report. There was insufficient information to determine reporter's causality assessment. Follow up pending.									U	10/27/2003	10/27/2003	0		UNK	UNK					PJP200300902	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230365	12/09/2004		76.0	75		F	10/08/2004	A report was received from a health care professional on 24 October 2003 concerning an octogenarian female who experienced rash and hives on her face and back of her neck 2 days after receiving Fluvirin on 20 October 2003. On 22 October 2003 the vaccinee experienced rash and hives on her face and back of her neck. On 24 October 2003 the vaccinee presented to a doctor's office and was prescribed loratadine, diphenhydramine hydrochloride, and prednisone (if condition worsened). The vaccinee had no known drug allergies and received the influenza vaccine in the past with out any problems. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 27 November 2003: Follow-up information received from a health care professional indicated the the 75 year old vaccinee recovered after three weeks.									Y	10/20/2003	10/22/2003	2		UNK	UNK					PJP200300906	1						1	Rash; Urticaria	FLU3~EVANS VACCINES~765853~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230366	12/09/2004		2.0	2	.1	M	10/08/2004	A report was received from a health care professional on 24 October 2003 concerning a 2 year old male vaccinee who inadvertently received Fluvirin on 21 October 2003. On 21 October a two year old vaccinee inadvertently received Fluvirin. The vaccinee did not complain of any adverse event at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 06 February 2004: A follow-up report was received from a health care professional indicating that the vaccinee had experienced no adverse events. No follow-up pending, all information received.									Y	10/21/2003	10/21/2003	0		UNK	UNK	Phenobarbital		Shaken baby syndrome which started as an infant.		PJP200300907	1						1	Medication error	FLU3~EVANS VACCINES~765798~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230367	12/09/2004					F	10/08/2004	A report was received from a health care professional who was also the consumer on 24 October 2003 concerning a female vaccinee of an unspecified age who experienced fever and injection site soreness 3 hours and 15 minutes after receiving Fluvirin on 24 October 2003. At 12.15 on 24 October 2003, the vaccinee experienced fever of approximately 99.9 degrees Fahrenheit and soreness in her upper extremity at the injection site. The outcome of the events were not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/24/2003	10/24/2003	0		UNK	UNK					PJP200300908	1						1	Injection site pain; Pyrexia	FLU3~EVANS VACCINES~765485~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230368	12/09/2004		54.0			M	10/08/2004	A report was received from a consumer on 10/24/2003 concerning a 54 year old vaccinee who experienced flu like symptoms with bad headache, fever, muscle aches, cramps weakness, congestion, sneezing, stiff neck and stiff should 1 day after receiving Fluvirin on 10/10/03. On 10/11/03 the vaccinee experienced flu like symptoms with bad headache, fever muscle aches, cramps, weakness, congestion sneezing, stiff neck and stiff shoulder. At the time of the report the vaccinee continued to have a headache, weakness, congestion and sneezing. the vaccinee took diphenhydramine hydrochloride and aspirin for relief of symptoms, neither of which was very effective. The vaccinee had not recovered at the time of the report. Update 1, 03/30/2004: a follow up report was received from a consumer indicating that he had experienced influenza, coughing and a stiff neck/shoulder almost continually since receiving Fluvirin on 10/10/2003. On 3/4/2004, the vaccinee attended an emergency room for chest pain du to excessive coughing. The reporter indicated that the doctor came to the conclusion that the vaccinee's chest wall had gone into spasm due to coughing. The vaccinee also attended a doctor on 02/19/2004 for should spasm and pain. Update 2, 05/11/2004: A follow up report was received from a health care professional indicating that he had seen the vaccinee in the emergency room for other reasons. Follow up pending.				Y					U	10/10/2003	10/11/2003	1		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200300909	1						1	Asthenia; Drug ineffective; Headache; Influenza; Influenza like illness; Muscle spasms; Musculoskeletal stiffness; Myalgia; Nasal congestion; Pyrexia; Sneezing	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0230369	12/09/2004					U	10/08/2004	A report was received from a health care professional on 10/24/2003 concerning an unspecified number of vaccinees of unknown demography who received 1 ml of the Fluvirin vaccine on 10/24/2003. The reporter was not aware of any adverse events at the time of report.  There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/24/2003				UNK	UNK	Concomitant Drug Not Reported.		No risk factors reported.		PJP200300910	1						1	Accidental overdose	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230370	12/09/2004		2.0	2	.2	M	10/08/2004	A report was received from a consumer on 10/24/2003 concerning a 2 year old male vaccinee who inadvertently received Fluvirin on 10/17/2003. On 10/17/2003 the vaccinee, who was less than 4 years of age inadvertently received Flurvirin. The vaccinee did not experinece any untoward effects after receiving the Fluvirin. Update 1, 2/16/2004: A follow up report was received from a health care professional indicating that no adverse event had occurred at the time of reporting. There was insufficient information to determine the reporter's causality assessment. No follow up pending, all information received.									U	10/17/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200300911	1						1	Medication error	FLU3~EVANS VACCINES~765874~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230371	12/09/2004		48.0	48		F	10/08/2004	A report received from a consumer on 10/27/2003 concerning a 48 year old female vaccinee who was administered a brand unspecified influenza vaccine via an unlicensed rout developed an injection site bump, and had a sore arm on the same day of receiving influenza vaccine on 10/17/2003. On 10/17/2003, the vaccinee was administered influenza vaccine subcutaneously, developed an injection site bump, and had a sore arm. The injection site bump and sore arm resolved on 10/27/2003. Update 1, 05/06/2004: Further information was received from a consumer indicating that she was not administered the influenza vaccine by her primary physician therefore her physician was unable to fill out the health professional form. No follow up pending, no further information available.									Y	10/17/2003	10/17/2003	0		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300912	1						1	Injection site mass; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0230372	12/09/2004		2.0	2	.3	M	10/08/2004	A report was received from a health care professional on 1/24/2003 concerning a 2 year old male vaccinee who inadvertently received Fluvirin on 10/17/2003. On 10/17/2004 the vaccinee, who was less than 4 years of age inadvertently received Fluvirin. The vaccinee did not experience any untoward effects after receiving the Fluvirin. There was insufficient information to determine the reporter's causality assessment. Update 11/27/2003: Follow up information was received from a health care professional on 11/27/2003 indicating that no sequelae was noted following vaccination. No follow up pending.									U	10/17/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		pjp200300913	1						1	Medication error	FLU3~EVANS VACCINES~765501~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230373	12/09/2004		72.0	71		F	10/08/2004	A report was received from a health care professional on 10/24/2003 concerning an octogenarian female who experienced rash and hives on her upper body and chest tightness 2 days after receiving Fluvirin on 10/22/03. On 1/24/2003 the vaccinee experienced rash and hives on her upper body and also chest tightness after she used her inhaler (type of medication unknown). She was prescribed loratadine, diphenhydramine hydrochloride, and prednisone (if condition worsened). The vaccinee had no known drug allergies and received the influenza vaccine in the past without any problems. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 11/27/2003: Follow up information received from a health care professional indicated that the 71 year old female vaccinee with generalized hives recovered on 11/27/2003.									Y	10/22/2003	10/24/2003	2		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200300914	1						1	Chest discomfort; Rash; Urticaria	FLU3~EVANS VACCINES~765853~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230374	12/09/2004		3.0	2	.6	F	10/08/2004	A report was received from a health care professional on 10/24/2003 concerning a 31 month old female vaccinee who was inadvertently administered Fluvirin vaccine on 10/21/2003. No adverse effects were associated with this inadvertent administration. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/12/2003: Follow up information received from a health care professional indicated that the vaccinee did not experience any adverse reaction. No follow up pending, all information received.									U	10/21/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200300915	1						1	Medication error	FLU3~EVANS VACCINES~765502~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230375	12/09/2004		33.0	32		F	10/08/2004	A report was received from a health care professional on 10/24/2003, concerning a 32 year old female vaccinee who was pregnant when she received Fluvirin on 10/22/2003. On 10/22/2003, the vaccinee received Fluvirin and subsequently reported she was approximately 5 weeks pregnant when vaccinated. No adverse event was reported at the time of this report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/22/2003				UNK	UNK	Prenatal vitamins		No risk factors reported. /Pregnant		PJP200300916	1						1	Unevaluable event	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230376	12/09/2004		35.0			F	10/08/2004	A report was received from a health care professional on 10/24/2003 concerning three female vaccinees of unknown age who were inadvertently administered last years vaccine (2002-2003) on an unknown date. No adverse reactions had occurred at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/10/2003: Follow up report was received from a health care professional on 12/10/2003 which indicated that a 35 year old female vaccinee inadvertently received 1 ml of expired Fluvirin on 10/23/2003. No adverse events were reported to date. Follow up pending.									U	10/23/2003				UNK	UNK	Concomitant Drug Not Reported.		No risk factors reported.		PJP200300917	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230377	12/09/2004					F	10/08/2004	A report was received from a health care professional on 10/24/2003 concerning a female vaccinee of approximately 75 years of age who experienced redness, swelling and pain at and below the injection site 3 hours after receiving Fluvirin on 10/23/2003. On 10/23/2003 the vaccinee experienced redness, swelling and pain at and below the injection site. The swelling was up to half size of an orange. The reporter was uncertain of the vaccinee's condition at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/23/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200300918	1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~EVANS VACCINES~765486~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230378	12/09/2004					U	10/08/2004	A report was received from a health care professional on 10/28/2003 concerning approximately 10 vaccinees of unknown demography who received a double dose of Fluvirin on 10/28/2003. No adverse events were reported at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 1, 03/01/04: Follow up information received from a health care professional indicated that none of the vaccinees experienced any adverse events. No follow up pending.									U	10/28/2003				UNK	UNK	Concomitant Drug Not Reported.		No risk factors reported.		PJP200300919	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~765140~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230379	12/09/2004		23.0	23		F	10/08/2004	A report was received from a health care professional on 10/28/03 concerning a 23 year old female vaccinee who experienced fluid filled spots that were red, itchy and raised on the day after receiving Fluvirin on 10/20/03. On 10/21/03 the vaccinee experienced fluid filed spots that were red, itchy and raised. The vaccinee had not recovered at the time of the report. There was insufficient information to determine that reporter's causality assessment. Follow up pending. Update 1, 12/11/03: A follow up report was received from a health care professional regarding the rash which was described as covering the torso, arms, legs and head and which was pimple like. The follow up report indicated that the spots eventually dried and disappeared. It has taken several weeks for them to disappear. No further follow up necessary.									Y	10/20/2003	10/21/2003	1		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200300921	1						1	Dermatitis acneiform; Pruritus; Rash erythematous	FLU3~EVANS VACCINES~765705~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230380	12/09/2004		44.0	44		F	10/08/2004	A report was received from a health care professional on 10/28/2003 concerning a 44 year old female vaccinee who inadvertently received expired Fluvirin on 10/28/2003. The vaccinee had not experienced any adverse effects at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/28/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200300922	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230381	12/09/2004		64.0	64		F	10/08/2004	A report was received from a health care professional on 10/28/2003 concerning a 64 year old female vaccinee who experienced pruritis 2 days days after receiving Fluvirin on 10/01/03. On 10/03/03, the vaccinee experienced pruritis on both arms, back and chest 2 days after receiving Fluvirin. The vaccinee went to the nurse on 10/27/03 about itching since the pruritis had continued for 3 weeks. Antihistamines were prescribed for the vaccinee. At the time of reporting the vaccinee had not recovered and it was unknown whether the antihistamines have helped relieve the pruritis. The reporter has assessed the  relationship of the vaccine to the event was unrelated due to the nature of the event and since the vaccinee has been receiving the influenza vaccination every year for many years with no adverse events. Update 1, 12/05/2003: Follow up information received from a health care professional on 12/05/2003, which indicated that the vaccinee also experienced hives and urticaria 1 and a half days after receiving Fluvirin. The vaccinee was treated with hydroxyzine panoate and chlorhexidine gluconate. The vaccinee recovered from the urticaria and hives on 10/31/2003. It was not reported if the vaccinee had recovered from the pruritis. The reporter has assessed the relationship of the Fluvirin to urticaria and hives as possible. Update 2, 1/23/2004: A follow up letter was received from a health care professional indicating that the pruritis had resolved on 10/31/2003. No follow up pending, all information received.									Y	10/01/2003	10/03/2003	2		UNK	UNK	Avandia, Atenolol, Lipitor,Antihistamines,Hydroxyzine Panoate, Chlorhexidine Gluconate		No risk factors reported. Coronary artery disease, Diabetes Type II		PJP200300923	1						1	Pruritus; Urticaria	FLU3~EVANS VACCINES~765484~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230382	12/09/2004		40.0	40		M	10/08/2004	A report was received from a health care professional on 10/28/2003 concerning a 40 year old male vaccinee who experienced pruritic urticaria 12 hours after receiving Fluvirin on 10/27/2003. On 10/28/2003, the vaccinee experienced pruritic urticaria on both his legs and arms 12 hours after receiving Fluvirin. The vaccinee took Clarinex which alleviated the symptoms. The vaccinee has received influenza vaccinations in the past without any difficulties. At the time of the report the vaccinee had not recovered. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 01/05/04: A follow up report was received from a health care professional concerning a vaccinee who developed urticaria after receiving Fluvirin on 10/27/2003. The follow up report indicated that the patient stated on 10/29/03 the family members (who did not have the flu vaccine) also had similar itching in the same time frame. The reporter's causality assessment on the follow up report indicated that the adverse experience were probably not due to the flu shot. Follow up pending.									U	10/27/2003				UNK	UNK	Concomitant Drug not Reported		No risk factors reported.		PJP200300924	1						1	Pruritus; Urticaria	FLU3~EVANS VACCINES~765502~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230383	12/09/2004		61.0			F	10/08/2004	A report was received from a health care professional on 10/28/2003 concerning a vaccinee of approximately 65 years of age who experienced overwhelming pain at the injection site immediately after receiving Fluvirin on 10/28/2003. On 10/28/2003 the vaccinee experienced overwhelming pain at the injection site after receiving 0.5ml of Fluvirin. An ice pack was applied and the pain decreased to soreness. The vaccinee had a prior history of influenza vaccination with no adverse events. The vaccinee had recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Up date 1, 03/01/2004: Follow up information received from a health car professional indicated that a 61 year old female vaccinee received Fluvirin on 10/24/2003 and experienced pain at the injection site which lasted approximately 10 minutes. No follow up pending. Cross reference with PJP20030926, PJP200300927, PJP200300928, PJP200300929, PJP200300930.									Y	10/28/2003	10/28/2003	0		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300925	1						1	Injection site pain	FLU3~EVANS VACCINES~765138~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230384	12/09/2004		52.0			F	10/08/2004	A report was received from a health care professional on 10/28/2003 concerning a female vaccinee of unspecified age who experienced overwhelming pain at the injection site immediately after receiving Fluvirin on 10/27/2003 and injection site swelling and redness and unspecified length of time after vaccination. On 10/27/03 the vaccinee experienced overwhelming pain at the injection site. The vaccinee also experienced injection site redness and swelling on an unspecified date. An ice pack was applied and the pain decreased to soreness. The vaccinee had a prior history of influenza vaccination with no adverse events. the vaccinee had recovered at the time of the report. There was insufficient information to determine the reporters causality assessment. Update 1, 03/01/04: Follow up information received from a health care professional indicated that a 52 year old female vaccinee experienced pain at the injection site running down her arm on 10/23/03 following Flurvirin vaccination. The event lasted approximately 30 minutes and resolved on the same day. No follow up pending. Cross reference with: PJP200300925, PJP200300927, PJP200300928, PJP200300929,PJP200300930.									Y	10/23/2003	10/23/2003	0		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200300926	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~EVANS VACCINES~765138~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230385	12/09/2004		59.0			F	10/08/2004	A report was received from a health care professional on 10/28/2003 concerning a female vaccinee of approximately 45 years of age who experienced overwhelming pain at the injection site immediately after receiving Fluvirin on 10/24/2003. An Ice pack was applied and the pain decreased to soreness. The vaccinee had a prior history of influenza vaccination with no adverse events. The vaccinee had recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 03/01/2004: Follow up information received from a health care professional indicated that a 59 year old female vaccinee experienced pain at the injection site running down the are which lasted approximately 20 minutes. No follow up pending. Cross reference with PJP200300925, PJP200300926, PJP200300928, PJP200300929, PJP200300930.									Y	10/24/2003	10/24/2003	0		UNK	UNK	Concomitant Drug not Reported		No risk factors reported		PJP200300927	1						1	Injection site pain	FLU3~EVANS VACCINES~765138~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230386	12/09/2004		65.0			F	10/08/2004	A report was received from a healthcare professional on 10/28/2003 concerning a female vaccinee of approximately 48 years of age who experienced overwhelming pain at the injection site immediately after receiving Fluvirin on 24 October 2003. On 24 October 2003 the vaccinee experienced overwhelming pain at the injection site.  An ice pack was applied and the pain decreased to soreness.  The vaccinee had a prior history of influenza vaccination with no adverse events.  The vaccinee recovered on an unspecified date.   There was insufficient information to determine the reporter's causality assessment. Update 1, March 2004 Follow up information received from a healthcare professional indicated that a 65 year old female vaccinee experienced pain at the injection site running down the arm which lasted approximately 15 minutes after receiving Fluvirin. No follow up pending.									Y	10/24/2003	10/24/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300928	1						1	Injection site pain	FLU3~EVANS VACCINES~765138~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230387	12/09/2004		15.0			F	10/08/2004	A report was received from a healthcare professional on 10/28/2003 concerning a female vaccinee of approximately 16 years of age who experienced overwhelming pain at the injection site immediately after receiving Fluvirin on 10/17/2003 and injection site swelling and redness an unspecified length of time after vaccination. On 10/17/2003 the vaccinee experienced overwhelming pain at the injection site.  The vaccinee also experienced injection site redness and swelling on an unspecified date.  An ice pack was applied and the pain decreased to soreness.  The vaccinee had a prior history of influenza vaccination with no adverse events.  The vaccinee recovered on an unspecified date. There was insufficient information to determine the reporter's causality assessment. Update 1, 01 March 2004 Follow up information received from a healthcare professional indicated that a 15 year old female vaccinee experienced redness and swelling at the injection site which lasted approximately 24 hours following receipt of Fluvirin on 10/17/2004. No follow up pending.									Y	10/17/2003	10/17/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300929	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~EVANS VACCINES~765138~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230388	12/09/2004		15.0			F	10/08/2004	A report was received from a healthcare professional on 10/28/2003 concerning a female vaccinee of approximately 16 years of age who experienced overwhelming pain at the injection site immediately after receiving Fluvirin on 10/17/2003. On 10/17/2003 the vaccinee experienced overwhelming pain at the injection site.  An ice pack was applied and the pain decreased to soreness.  The vaccinee had a prior history of influenza vaccination with no adverse events.  The vaccinee recovered on an unspecified date. There was insufficient information to determine the reporter's causality assessment. Update 1 01 March 2004 Follow up information received from a healthcare professional indicated that a 15 year old female vaccinee also experienced swelling and redness at the injection site which lasted 24 hours following receipt of Fluvirin. No follow up pending.									Y	10/17/2003	10/17/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300930	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~EVANS VACCINES~765138~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230389	12/09/2004		7.0			U		A report received from a healthcare professional on 10/29/2003, concerned a 7 year old vaccinee of unknown sex, who received a sub-optimal dose of Fluvirin on 10/25/2003. On 25 October 2003, a 7 year old vaccinee received 0.25ml Fluvirin, instead of 0.5ml.  There were no adverse reactions reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/25/2003	10/25/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300931	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230390	12/09/2004		2.0			U	10/08/2004	A report was received from a healthcare professional on 10/28/2003 concerning a 2 year old vaccinee of unknown sex who was inadvertently administered Fluvirin on an unknown date. On an unknown date, the vaccinee was inadvertently administered Fluvirin.  No additional information was provided at the time of the report. There was insufficient information to determine the reporter's causality assessment.									U					UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300933	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230391	12/09/2004		79.0	79		F	10/28/2003	A report was received from a healthcare professional on 10/28/2003 concerning a vaccinee of unspecified demography who inadvertently received two doses of Fluvirin on an unspecified date. On an unspecified date the vaccinee inadvertently received two doses of Fluvirin on an unspecified date.  It was not reported if the vaccinee had experienced an adverse reaction. There was insufficient information to determine the reporter's causality assessment. Update 1, 11/25/2003 Follow up information received from a healthcare professional indicated that a 79 year old female vaccinee was inadvertently administered Fluvirin on 10/28/2003, having previously received Fluvirin on 10/24/2003.  No adverse events were reported at the time of report.									U	10/24/2003	10/28/2003	4		UNK	UNK	Artificial tears (GTTS) Constipation drug Plavix Mitrazapine Insulin Calcium Carbonate Ferrous Sulfate Vitamins		No risk factors reported.		PJP200300934	1						1	Medication error	FLU3~EVANS VACCINES~765855~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230392	12/09/2004					M	10/08/2004	A report was received from a healthcare professional on 10/29/2003 concerning a male vaccinee of unspecified age who experienced dizziness, fatigue and pain at the injection site on the night after receiving Fluvirin at 9AM on 10/28/2003. On the night of 10/28/2003 the vaccinee experienced dizziness, fatigue and pain at the injection site after receiving Fluvirin.  The symptoms had not resolved at the time of report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									N	10/28/2003	10/28/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300935	1						1	Dizziness; Fatigue; Injection site pain	FLU3~EVANS VACCINES~765144~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230393	12/09/2004		65.0			M	10/08/2004	A report was received from a healthcare professional on 10/29/2003 who is a 65 year old male vaccinee who inadvertently received expired Fluvirin on 10/29/2003. On 10/29/2003 the vaccinee inadvertently received a dose of 2002-2003 expired Fluvirin.  The vaccinee had not experienced any adverse effects at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 23 February 2004: Further information was received from a healthcare professional indicating that he experienced no adverse reaction. No follow up pending, all information received.									U	10/29/2003	10/29/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300936	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230394	12/09/2004		45.0	44		F	10/08/2004	A report was received from a healthcare professional concerning a female vaccinee of unspecified age who experienced a rash and itching on the neck the day after receiving Fluvirin on 10/28/2003. On the 10/29/2003, the vaccinee experienced a rash and itching in the neck region.  The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 16 February 2004. A follow up report was received from a healthcare professional indicating that the 44 year old vaccinee developed an itchy rash over arms and trunk, the day after receiving Fluvirin.  According to the reporter the event is most likely resolved as the vaccinee did not call back.  No follow up pending, no further information available.									U	10/28/2003	10/29/2003	1		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300937	1						1	Pruritus; Rash	FLU3~EVANS VACCINES~765796~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230395	12/09/2004		37.0	37		F	10/08/2004	A report was received from a healthcare professional concerning a female vaccinee of unspecified age who experienced a rash and itching on her whole body 2 days after receiving Fluvirin on 10/21/2003. On the 23 October 2003, the vaccinee experienced a rash and itching on her whole body.  The vaccinee recovered approximately 5 days later. There was insufficient information to determine the reporter's causality assessment. Update 1, 16 February 2004. A follow up report was received from a healthcare professional concerning a 37 year old vaccinee who experienced a generalized itchy rash on her arms, trunk and back on 17 October 2003, 2 days after receiving Fluvirin on 10/15/2003. According to the reporter the event is most likely resolved. No follow up pending, no further information available.									U	10/15/2003	10/17/2003	2		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300938	1						1	Pruritus; Rash	FLU3~EVANS VACCINES~765712~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230396	12/09/2004		57.0	56		F	10/08/2004	A report received from a healthcare professional on 10/29/2003, concerned a 57 year old female vaccinee who accidentally received a dose of Fluvirin on 10/21/2003 and a second dose on 10/29/2003. On 10/21/2003, the vaccinee received a dose of Fluvirin and a second dose was administered on 10/29/2003.  No adverse effects have occurred at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 12 December 2003 The vaccinee was 56 years old at the time of the accidental overdose and received the first dose of Fluvirin on 20 October 2003.									U	10/20/2003	10/29/2003	9		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300939	1						1	Medication error	FLU3~EVANS VACCINES~765500~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230397	12/09/2004		18.0			F	10/08/2004	A report was received from a health care professional on 10/29/2003 concerning 3 vaccinees of unknown demography who inadvertently received expired Fluvirin on an unspecified date. On an unspecified date 3 vaccinees were administered a dos of 2002-2003 Fluvirin. It was not reported if the vaccinees had experienced any adverse reaction at the time of report. There was insufficient information to determine the reporter's causality assessment. Update 1, 02/24/04: Follow up information received from a health care professional indicated that an 18 year old female vaccinee inadvertently received expired Fluvirin on an unspecified date in September 2003. No adverse events were reported. Follow up pending. Cross reference to PJP200400146, PJP200400147 and PJP200400148.									U					UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300940	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230398	12/09/2004		26.0			F	10/08/2004	A report was received from a health care professional on 10/29/2003 who is a 26 year old female vaccinee who experienced localized itching and burning at the vaccination site an unspecified length of time after inadvertently receiving Fluvirin subcutaneously on 10/29/2003. It was not reported if the vaccinee had recovered at the time of the report. There was insufficient information to determine the reporter's causality. Follow up pending.									U	10/29/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200300941	1						1	Injection site hypersensitivity; Medication error; Pruritus; Thermal burn	FLU3~EVANS VACCINES~765872~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230399	12/09/2004					F	10/08/2004	A report was received from a health care professional on 10/29/03 concerning an unspecified number of vaccinees of unspecified demography who experienced localized hives, swelling, redness and itching an unspecified length of time after receiving Fluvirin on an unknown date. The reporter noted many more local adverse effects than usual with the 2003-2004 Fluvirin. It was not reported if the vaccinee's had recovered at the time of the report. There was insufficient information to determine the reporter's causality. Update 1, 02/16/2004: A follow up report was received from a health care professional indicating that a female vaccinee of unspecified age developed redness and swelling at the injection site which was warm to the touch on 10/28/03, 1 day after receiving Fluvirin on 10/27/2003. The vaccinee also developed a fever of 100F. The outcome of the adverse events was not reported at the time of reporting. Update 2, 04/16/2004: Further information was received from a health care professional which indicated that the vaccinee's symptoms resolved and no further symptoms were reported as of April 2004. No follow up pending, all information received. Cross reference with: PJP200400141, PJP200400142, PJP200400143, PJP200400144, PJP200400145.									Y	10/27/2003	10/28/2003	1		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300942	1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Injection site urticaria; Injection site warmth; Pruritus; Pyrexia	FLU3~EVANS VACCINES~765499~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230400	12/09/2004		2.0			F	10/08/2004	A report was received from a health care professional on 10/29/03 concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 10/29/03. At the time of the report no adverse effects occurred. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/10/03: Follow up information received from a health care professional indicated that the vaccinee did not experience any adverse reaction.									U	10/29/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300943	1						1	Medication error	FLU3~EVANS VACCINES~765340~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230401	12/09/2004		41.0	41		F	10/08/2004	A report was received from a health care professional on 10/29/2003 concerning a 41 year old female vaccinee who experienced injection site redness 12 hours after receiving Fluvirin on 10/28/03. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. See Ref.: PJP200300946, PJP200300947,PJP20030048.									U	10/28/2003				UNK	UNK	Concomitant Drug Not Used		No risk factors reported		PJP200300945	1						1	Injection site erythema	FLU3~EVANS VACCINES~765496~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230402	12/09/2004		52.0	52		F	10/08/2004	A report was received from a health care professional on 10/29/2003 concerning a 52 year old female vaccinee who experienced injection site redness and warmth on the same day and itching eyes and ears 10 hours after receiving Fluvirin on 10/28/2003. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update1, 04/15/2004: A follow up report was received from a health care professional indicating that the vaccinee had recovered on an unspecified date. No follow up pending all information received. See Ref.: PJP200300945, PJP200300947, PJP200300948.									Y	10/28/2003	10/28/2003	0		UNK	UNK	Concomitant Drug Not Used		No risk factors reported		PJP200300946	1						1	Eye disorder; Injection site erythema; Injection site warmth; Pruritus	FLU3~EVANS VACCINES~765496~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230403	12/09/2004		34.0	34		F	10/08/2004	A report was received from a health care professional on 10/29/2003 concerning a 34 year old female vaccinee who experienced injection site redness and warmth 15 minutes after vaccination. Chest tightness and itching 30 minutes after vaccination. Fever in the evening of the same day as receiving Fluvirin on 10/21/03. On 10/21/2003, after receiving Fluvirin the vaccinee experienced injection site redness and warmth 15 minutes later, chest tightness and itching extending from the upper arm to the elbow and itching on the face and eyes 30 minutes later and fever of 100 degrees fahrenheit that evening. The injection site redness and warmth resolved on 10/26/2003. the vaccinee recovered on an unspecified date. There was insufficient information to determine the reporter's causality assessment. Update 1, 04/15/2004: A follow up report was received from a health care professional indicating that the redness and itching in the upper arm resolved 15 minutes and the tightness in her chest, itching eyes and itching face resolved after 30 minutes. No follow up pending, all information received. See Ref.: PJP200300945, PJP200300946, PJP200300948.									Y	10/21/2003	10/21/2003	0		UNK	UNK	Concomitant Drug Not Used		No risk factors reported.		PJP200300947	1						1	Chest discomfort; Eye disorder; Injection site erythema; Injection site warmth; Pruritus; Pyrexia	FLU3~EVANS VACCINES~765496~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230404	12/09/2004		27.0	27		F	10/08/2004	A report was received from a health care professional on 10/29/03 concerning a 27 year old female vaccinee who experienced injection site redness and warmth one day after vaccination, and itching of the arms and eyes 2 days after receiving Fluvirin on 10/27/03. On 10/28/03 the vaccinee experienced injection site redness and warmth. On 10/29/03 the vaccinee experienced itching of the arms and eyes. the vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. See Ref.: PJP200300945, PJP200300946, PJP200300947.									U	10/27/2003	10/28/2003	1		UNK	UNK	Concomitant Drug Not Used		No risk factors reported		PJP200300948	1						1	Eye disorder; Injection site erythema; Injection site warmth; Pruritus	FLU3~EVANS VACCINES~765496~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230405	12/09/2004		62.0			F	10/08/2004	A report was received from a health care professional on 10/30/03, concerning a 62 year old female vaccinee who inadvertently received a sub optimal dose of Fluvirin on 10/30/03. On 10/30/2003, the vaccinee inadvertently received a dose of Fluvirin where some of the vaccine dripped down her arm. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/30/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300949	1						1	Medication error	FLU3~EVANS VACCINES~765876~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230406	12/09/2004		2.0			M	10/08/2004	A report was received from a health care professional on 10/30/03 concerning a 2 year old male vaccinee who inadvertently received Fluvirin on 10/29/03. On 10/29/03, a vaccinee under 4 years of age inadvertently received Fluvirin vaccine. The vaccinee had not experienced any adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 01/02/04: Further information was received from a health care professional on 01/02/04 indicating that the vaccinee did not experience any adverse reaction. No follow up pending, all information received. See Ref.: PJP200300952.									U	10/29/2003				UNK	UNK	Concomitant Drug Not Used		No risk factors reported		PJP200300951	1						1	Medication error	FLU3~EVANS VACCINES~765795~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230407	12/09/2004		3.0			F	10/08/2004	A report was received from a healthcare professional on 30 October 2003 concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 29 October 2003. On 29 October 2003, a vaccinee under 4 years of age inadvertently received Fluvirin vaccine.  The vaccinee had not experienced any adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 02 January 2004: Further information was received from a healthcare professional on 02 January 2004 indicating that the vaccinee did not experience any adverse reaction. No follow up pending, all information received.									U	10/29/2003	10/29/2003	0		UNK	UNK	Concomitant drug not used.		No risk factors reported.		PJP200300952	1						1	Medication error	FLU3~EVANS VACCINES~765795~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230409	12/09/2004		81.0	81		M	10/08/2004	A report was received from a healthcare professional on 30 October 2003 concerning an 81 year old male vaccinee who was administered 2 doses of Fluvirin on 29 October 2003. On 29 October 2003, the vaccinee was administered 0.5ml Fluvirin in his left deltoid and 0.5ml in his right deltoid.  The vaccinee was inadvertently administered the second dose of influenza vaccine instead of Pneumovax.  The vaccinee did not experience any adverse reactions at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/29/2003	10/29/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300954	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~765707~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230410	12/09/2004					U	10/08/2004	A report was received from a healthcare professional on 30 October 2003 concerning approximately 10 vaccinees under 4 years of age of unknown demographics who inadvertently received 0.25ml of Fluvirin on an unspecified date. On an unspecified date approximately 10 vaccinees under 4 years of age inadvertently received 0.25ml of Fluvirin.  No adverse effects had occurred at the time of report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300955	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230411	12/09/2004					M		A report was received from a healthcare professional on 30 October 2003 concerning a male vaccinee in his forties who inadvertently received 0.5ml of expired Fluvirin on 27 October 2003. On 27 October 2003 the vaccinee inadvertently received 0.5ml of 2002-2003 Fluvirin.  No adverse effects had occurred at the time of report. There was insufficient information to determine the reporter's causality assessment. Update 1, 16 February 2004. A follow up report was received from a healthcare professional indicating that no adverse event had occurred at the time of reporting.  The vaccinee received this year's vaccine 3 weeks later. No follow up pending, all information received.									U	10/27/2003	10/27/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300956	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230412	12/09/2004		1.0			M		A report was received from a health care professional on 30 October 2003, concerning an unspecified number of vaccines under 4 years of age who inadvertently received Fluvirin on an unspecified date.  On an unspecified date,an unspecified number of vaccines under 4 years of age inadvertently received Fluvirin.  No adverse effects had occurred at the time of report.  There was insufficient information to determine the reporter's causality assessment.  Updated 1, 01 December 2003.  Follow- up information received from a health care professional indicated that a 1 year old male vaccine inadvertently received Fluvirin on 18 October 2003 and had not experienced any adverse event at the time of the report.  No follow-up pending, all information received.									U		10/18/2003			UNK	UNK					pjp200300957	1						1	Medication error	FLU3~EVANS VACCINES~765497~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230413	12/09/2004		84.0			M		A report was received from a health care professional on 30 October 2003 concerning a 70 year old male vaccine who inadvertently received expired Fluvirin on 30 October 2003.  On 30 October 2003 the vaccine inadvertently received a dose of Fluvirin which expired on 31 May 2003.  On adverse effects had occurred at the time of report.  There was insufficient information to determine the reporter's causality assessment.  Update 1 01, March 2004 Follow- up information received from a health care professional indicated that an 84 year old male vaccine did not experience any adverse events following receipt of expired vaccine.  No follow-up pending.									U	10/30/2003	10/30/2003	0		UNK	UNK					pjp200300958	1						1	Medication error	FLU3~EVANS VACCINES~E31212HA~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230414	12/09/2004		29.0	29		F		A report was received from a health care professional on 30 October 2003 concerning a 29 year old female vaccine who experienced tenderness at the site of injection the day of receiving Fluvirin, and a painful and tender arm 1 day after inadvertently receiving Fluvirin subcutaneously on 29 October 2003.  On 29 October 2003, the vaccine experienced a little hit of tenderness at the site of injection after receiving Fluvirin on the same day.  The Fluvirin was inadvertently administered subcutaneously.  On the morning of 30 October 2003, the vaccine experienced more discomfort and there was a long patch about 3 x 1 inches on the back of her left arm which was painful and tender.  The reporter indicated that the vaccine may have inadvertantly received Fluvirin subcutaneously instead of intranuscularly.  The vaccine is applying ice packs to the arm.  The patient had not recovered at the time of the event.    There was insufficient information to determine the reporter's causality assessment.  Update 1, 16 April 2004 Follow-up information received from a health care professional indicted that the vaccine experienced pain and redness of the left upper arm on 29 October 2003.  The vaccine was also treated with ibprofen and heat for 2-3 days.  These events resolved on 31 October 2003.  No follow-up pending, all information received.									U	10/29/2003	10/29/2003	0		UNK	UNK					pjp200300959	1						1	Injection site pain	FLU3~EVANS VACCINES~~2~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230415	12/09/2004		50.0			M	10/08/2004	A report was received from a health care professional on 31 October 2003 concerning a 50 year old male vaccine who inadvertently received a double dose of Fluvirin on 31 October 2003.  On 31 October 2003 the vaccine received a double dose of Fluvirin.  The vaccine had experienced no adverse reaction at the time of the report.  No follow-up pending, all information received.  There was insufficient information to determine the reporter's causality assessment.  Update 1, 17 February 2004.  A follow-up report was received from a health care professional indicating that no adverse event had occurred at the time of reporting.									U	10/31/2003	10/31/2003	0		UNK	UNK					PJP200300960	1						1	Medication error	FLU3~EVANS VACCINES~765181~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230416	12/09/2004		61.0			F	10/08/2004	A report was received from a health care professional on 31 October 2003 concerning a 61 year old female vaccine who inadvertently received a double dose of Fluvirin on 31 October 2003.  On 31 October 2003 the vaccine received a double dose of Fluvirin.  The vaccine had experienced no adverse reaction at the time of the report.  There was insufficient information to determine the reporter's causality assessment.  Update 1, 17 February 2004.  A follow-up report was received from a health care professional indicating that no adverse event had occurred at the time of reporting.  No follow-up pending, all information received.									U	10/31/2003	10/31/2003	0		UNK	UNK					PJP200300961	1						1	Medication error	FLU3~EVANS VACCINES~765181~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230417	12/09/2004		28.0			F	10/08/2004	A report was received from a health care professional on 10/31/2003 concerning a 28 year old female vaccinee who inadvertently received a double dose of Fluvirin on 10/31/2003. The vaccinee had experienced no adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 02/17/2004: A follow up report was received from a health care professional indicating that no adverse event had occurred at the time of reporting. No follow up pending, all information received. See ref: PJP200300960 and PJP200300961.									U	10/31/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300962	1						1	Medication error	FLU3~EVANS VACCINES~765181~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230418	12/09/2004		2.0			F	10/08/2004	A report was received from a health care professional on 10/31/03, concerning a 2 year old male vaccinee who was inadvertently administered Fluvirin on 10/31/03. The vaccinee had experienced no adverse effects at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update report 01/05/04: Follow up information received from a health care professional indicated that the female vaccinee was inadvertently administered 0.5ml of Fluvirin. Follow up pending.									U	10/31/2003				UNK	UNK	Concomitant Drug Not reported		No risk factors reported		PJP200300963	1						1	Medication error	FLU3~EVANS VACCINES~765703~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230419	12/09/2004					F	10/08/2004	A report was received from a consumer on 10/31/03, who is a female vaccinee of unspecified age, who developed approximately 20 raised red itchy spots on her torso, arms and neck 6 days after receiving an unspecified brand of Influenza vaccine on 10/23/03. The vaccinee reported that her husband has poison ivy and that the vaccinee used the same bathtub, which her husband had used the previous day and 24 hours later, the vaccinee developed the spots. The vaccinee has tolerated Flu vaccines in the past without any difficulties. At the time of the report the vaccinee had not recovered. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/23/2003	10/29/2003	6		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported. Toleration of Flu vaccines in the past without difficulties.		PJP200300965	1						1	Pruritus; Rash erythematous	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0230420	12/09/2004		3.0	2	1	M	10/08/2004	A report was received from a health care professional on 10/31/03 concerning a 30 month old male vaccinee who was inadvertently administered Fluvirin on 10/31/03. The vaccinee had not experienced any adverse effects at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1, 02/19/04: A follow up report was received from a health care professional indicating that the vaccinee was two years old and received Fluvirin on 10/22/03. No adverse events had occurred at the time of reporting. No follow up pending, all information received.									U	10/22/2003				UNK	UNK	Concomitant Drug Not Report		No risk factors reported.		PJP200300966	1						1	Medication error	FLU3~EVANS VACCINES~765853~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230421	12/09/2004		68.0	67		F	10/08/2004	A report was received from a health care professional on 10/31/03, concerning a 67 year old female vaccinee who inadvertently received 2 doses of Fluvirin, on on 10/28/03 and another on 10/31/03. The vaccinee did not experience any adverse reaction at the time of the report.  There was insufficient information to determine the reporter's causality assessment. Update 1, 12/10/2003: A follow up report was received from a health care professional which indicated that the vaccinee's vital signs were monitored every 8 hours for 2 days after she inadvertently received 2 doses of Fluvirin. There were no problems, changes or adverse reactions noted. No follow up pending.									U	10/28/2003				UNK	UNK	Roxanol 10/17/03 20mg/ml every 2 hrs as required, Captopress-TTS 08/16/2003 1, 1in wk, Albuterol NEB 10/09/03 0.083, 2in 1, Atrovent NEB 10/09/03 0.5mg/2.5ml 2 in 1 D, Duragesic 10/29/03 75 MCG/HR 1 in 72 hr, Ativan tabs 10/30/03 4mg 1mg, 1		No risk factors reported. Pain, HTN, COPD and Anxiety		PJP200300967	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~765795~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230422	12/09/2004		55.0			F	10/08/2004	A report was received from a health care professional on 11/02/03 concerning a 55 year old female vaccinee who inadvertently received expired Fluvirin on 11/1/03. the vaccinee had experienced no adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 02/02/2004: A follow up report was received from a health care professional indicating that the vaccinee inadvertently received 1 ml of expired Fluvirin on 11/01/03. No adverse events were reported at the time of the follow up report. No follow up pending, all information received. See ref.: PJP200300969 and PJP200300970.									U	11/01/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300968	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~E35792KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230423	12/09/2004		50.0			F	10/08/2004	A report was received from a health care professional on 11/02/03 concerning a 50 year old female vaccinee who inadvertently received expired Fluvirin on 11/01/03. The vaccinee had experienced no adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 02/02/04: A follow up report was received from a health care professional indicating that the vaccinee inadvertently received 1ml of expired Fluvirin on 11/01/03. No adverse events were reported at the time of the follow up report. No follow up pending, all information received. See ref>: PJP200300968 and PJP20030970>									U	11/01/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200300969	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~E35792KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230424	12/09/2004		30.0			M	10/08/2004	A report was received from a health care professional on 11/02/03 concerning a 30 year old male vaccinee who inadvertently received expired Fluvirin on 11/1/03. The vaccinee had experienced no adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 02/02/04: A follow up report was received from a health care professional indicating that the vaccinee inadvertently received 1ml of expired Fluvirin on 11/01/03. No adverse events were reported at the time of the follow up report. No follow up pending, all information received. See ref.: PJP200300968 and PJP200300969.									U	11/01/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200300970	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~E35792KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230425	12/09/2004		48.0			F	10/08/2004	A report was received from a health care professional on 11/03/03 concerning a female vaccinee of unknown age who experienced swelling, pain, warmth and tenderness at the injection site 1 day after receiving Fluvirin on 10/30/03. The reporter recommended symptomatic treatment with an ice pack at the affected area. On 11/03/03 the vaccinee had not yet recovered and indicated using a heat pack instead of an ice pack. The vaccinee is to attend her physician for further follow up. There was insufficient information to determine the reporter's causality assessment. Update 1, 02/23/04: Further information was received from a health care professional indicating that the vaccinee was 48 years old and experienced extreme pain in her arm which had spread from the injection site 6 hours following vaccination and resolved on 11/30/03. The vaccinee also experienced pain and swelling in her shoulder. The vaccinee visited her physician twice and her symptoms were treated with antibiotic and anti-inflammatory agents. No follow up pending, all information received.				Y					Y	10/30/2003	10/31/2003	1		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300971	1						1	Injection site pain; Injection site swelling; Injection site warmth; Joint swelling	FLU3~EVANS VACCINES~765795~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0230426	12/09/2004		2.0	2	.1	M	10/08/2004	A report was received from a healthcare professional on 11/03/2003 concerning a 3 year old vaccinee of unspecified gender who inadvertently received Fluvirin on an unspecified date. On an unspecified date the vaccinee, who was less than 4 years of age inadvertently received Fluvirin.  The vaccinee had not experienced any adverse effects at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 02 January 2004: Follow up information received from a healthcare professional indicated that a 2 year old male vaccinee inadvertently received Fluvirin.  The vaccinee did not experience any adverse events, as a result. Update 2, 10 February 2004: Further information received from a healthcare professional on 10 February 2004 indicated that the vaccinee received Fluvirin on 01 November 2003.  The vaccinee did not get re-vaccinated and did not develop the Flu. No follow up pending, all information received.									U	11/01/2003				UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300972	1						1	Medication error	FLU3~EVANS VACCINES~765669~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230427	12/09/2004					U	10/08/2004	A report was received from a healthcare professional on 3 November 2003 concerning two vaccinees of unspecified demography who experienced fatigue, achiness and headache the day after receiving Influenza vaccine (brand unspecified) on an unspecified date. On an unspecified date two vaccinees experienced fatigue, achiness and headache.  Both vaccinees had received influenza vaccine in previous years without any side effects.  The outcome of the events were not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	Concomitant drugs not reported.		No risk factors reported.		PJP200300973	1						1	Fatigue; Headache; Pain	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230428	12/09/2004					U	10/08/2004	A report was received from a healthcare professional on 3 November 2003 concerning an unspecified number of vaccinees who experienced mild headache an unspecified length of time after receiving Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees experienced mild headache.  The vaccinees recovered 2 to 3 days later. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300974	1						1	Headache	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230429	12/09/2004					U	10/08/2004	A report was received from a healthcare professional on 3 November 2003 concerning a vaccinee of unspecified demography who experienced severe headache, malaise and bodyache an unspecified length of time after receiving Fluvirin on an unspecified date. On an unspecified date the vaccinee experienced severe headache, malaise and bodyache.  The vaccinee was negative for influenza virus in serum.  The symptoms were relieved with naproxen sodium and ibuprofen.  The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200300975	1						1	Headache; Malaise; Pain	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230431	12/09/2004		99.0	98		F	10/08/2004	A report was received from a health care professional on 11/04/03 concerning a 98 year old female vaccinee who was inadvertently administered 2 doses of Fluvirin, the first on 10/20/03 and the second on 11/04/03. On 10/20/03 and 11/04/03 respectively, the vaccinee was inadvertently administered 2doses of Fluvirin, the first into the left deltoid and the second into the right deltoid. There was no adverse events at the time of the report. There insufficient information to determine the reporter's causality assessment.  Update 1, 12/12/03: Follow up information received from a health care professional indicated that the vaccinee did not experience any adverse reaction. No follow up pending.									U	10/20/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported. Angina and Alzheimer's disease.		PJP200300980	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~765601~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230432	12/09/2004		62.0			F	10/08/2004	A report was received from a health care professional on 11/04/03 concerning a unspecified number of vaccinees who inadvertently received expired Fluvirin on an unspecified date. It was unknown whether or not any vaccinees had experienced any adverse events. There was insufficient information to determine the reporter causality assessment. Follow up pending. Update 1, 12/10/03: A follow up report received from a health care professional indicated that a 62 year old female vaccinee inadvertently received expired Fluvirin on 11/03/03. No side effects were observed at the time of the report. Follow up pending.									U	11/03/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200300981	1						1	Medication error	FLU3~EVANS VACCINES~E30152GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230433	12/09/2004					M	10/08/2004	A report was received from a health care professional on 11/04/03, concerning a male vaccinee of unknown age who received 2 doses of Fluvirin, the first on 10/23/03 and the second on 11/04/03. On 10/23/03, the vaccinee received 035ml Fluvirin. Subsequently on 11/04/03 the vaccinee was inadvertently administered 0.5ml Fluvirin instead of the pneumococcal vaccine. The vaccinee had not exhibited any adverse events at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/10/03: Follow up information received from a health care professional on 12/10/03 indicated that the reporter had followed up with the patient on 12/02/03 and the patient was feeling well and had no adverse events. No follow up pending.									U	11/04/2003				UNK	UNK	Concomitant Drug Not Reported		NO risk factors reported		PJP200300982	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~765179~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230434	12/09/2004		0.5			M	10/08/2004	A report was received from a health care professional on 11/04/2003 concerning a 6 month old male vaccinee who inadvertently received Fluvirin on 10/10/2003. The vaccinee had not experienced any adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. See Ref.: PJP200300984 and PJP200300985.									U	10/10/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300983	1						1	Medication error	FLU3~EVANS VACCINES~765799~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230435	12/09/2004		0.9			M	10/28/2004	A report was received from a health care professional on 11/04/2003 concerning a 9 month old male vaccinee who inadvertently received Fluvirin on 10/29/2003. the vaccinee had not experienced any adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 11/25/2003: A follow up report was received from a health care professional which indicated that the vaccinee was 11 months old when he received Fluvirin on 10/28/2003. The vaccinee had still not experienced any adverse reaction at the time of the report. No follow up pending. See Ref.: PJP200300983 and PJP200300985.									U	10/29/2003				UNK	UNK	Concomitant Drug Not Used		No risk factors reported		PJP200300984	1						1	Medication error	FLU3~EVANS VACCINES~765799~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230436	12/09/2004		3.5			M	10/08/2004	A report was received from a health care professional on 11/04/03 concerning a 24 month old male vaccinee who inadvertently received Fluvirin on 10/29/03. The vaccinee had not experienced any adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 11/25/03: A follow up report was received from a health care professional which indicated that the vaccinee was 31 months old when he received Fluvirin on 10/28/03. The vaccinee had still not experienced any adverse reaction at the time of the report. No follow up pending. See Ref.: PJP200300983 and PJP200300984.									U	10/28/2003				UNK	UNK	Zyrtec		No risk factors reported. Unspecified allergies.		PJP200300985	1						1	Medication error	FLU3~EVANS VACCINES~765799~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230437	12/09/2004		25.0	25		M	10/08/2004	A report was received from a health care professional on 11/05/03, concerning a 25 year old male vaccinee who experienced swelling and pain the same day of receiving Fluvirin in his left deltoid on 11/3/03. On 11/3/03, the vaccinee experienced swelling in the left upper area and pain. the vaccinee had not yet recovered at the time of reporting. There was insufficient information to determin the reporter's causality assessment. Follow up pending.									N	11/03/2003	11/03/2003	0		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300986	1						1	Pain; Swelling	FLU3~EVANS VACCINES~765876~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230438	12/09/2004					F	10/08/2004	A report was received from a health care professional on 11/04/03, concerning a female vaccinee of unknown age who developed a quarter sized knot which was red and hot an unspecified length of time after receiving Fluvirin vaccine on 10/07/2003. The outcome was unknown at the time of the report. There was insufficient information to determine the reporter's causality assessment. No follow up pending. Cross reference with: PJP20030785, PJP200300786 and PJP200300988.									U	10/07/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP20000987	1						1	Injection site erythema; Injection site induration; Injection site warmth	FLU3~EVANS VACCINES~765178~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230439	12/09/2004					F	10/08/2004	A report was received from a health care professional on 11/04/2003, concerning a female vaccinee of unknown age who developed a quarter sized knot which was red and a very sore arm an unspecified length of time after receiving Fluvirin on 10/16/2003. The outcome was unknown at the time of the report. There was insufficient information to determine the reporter's causality assessment. No follow up pending. Cross reference with: PJP20030785, PJP200300786 and PJP200300987.									U	10/16/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200300988	1						1	Injection site erythema; Injection site induration; Pain	FLU3~EVANS VACCINES~765178~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230440	12/09/2004					M	10/08/2004	A report was received from a health care professional on 11/05/2003, concerning a male vaccinee of unknown age who developed oculorespiratory syndrome an unspecified length of time after receiving Fluvirin on an unknown date. The vaccinee is HIV positive. The outcome of the oculorespiratory syndrome was not reported. The reporter has assessed the relationship of the vaccinee to the event as unrelated. Follow up pending.									U					UNK	UNK	Concomitant Drug Not Reported		No risk factors reported. HIV positive		PJP200300989	1						1	Respiratory disorder	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230441	12/09/2004					F		Injection site swelling (Injection site edema, injection site edema) (Edema inject site) - recovered/resolved Injection site redness (injection site reaction, injection site reaction)(inject site react) - recovered/resolved Injection site warmth (Injection site reaction, injection site reaction) (Inject site react)- recovered/resolved Administration by an unlicensed route (Medication error, medication error) (Med error) - recovered/resolved     A report was received from a health professional on 05 November 2003, concerning approximately 20 vaccines who experienced local swelling, warmth and redness at the injection site an unspecified length of time after inadvertently receiving Fluvirin subcutaneously between 03 November - 04 November 2003. Between 03 November - 04 November 2003, the vaccines experienced local swelling, warmth and redness at the injection site. No other information was available. There was insufficient information to determine the reporter's causality assessment. Update 1, 09 March 2004 Follow-up information received from a health care professional indicated that approximately 18-20 female vaccines received Fluviron on 05 November 2003 subcutaneously and within 1 hour of administration experienced local swelling and redness at injection site. The adverse reactions resolved approximately 12-24 hours later. No long term complications were reported. No follow-up pending, all information recevied.									Y	11/05/2003	11/05/2003	0		UNK	UNK					PJP200300990	1						1	Feeling hot; Injection site erythema; Injection site oedema; Medication error	FLU3~EVANS VACCINES~766052~2~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230442	12/09/2004		45.0	44		F	10/08/2004	Injection site redness (Injection site reaction, injection site reaction)(Inject site react) not recovered/not resolved  Injection site raised (Injection site edema, injection site edema)(Edema inject site) - not recovered/not resolved Injection site sore (Injection site pain)(Pain inject site) - not recovered/not resolved Injection site hot (Injection site reaction, Injection site reaction)(Inject site react) - not recovered/not resolved Diarrhea (Diarrhea, Diarrhea) (Diarrhea) - not recovered/not resolved A report was received from a consumer on 05 November 2003, concerning a 44 year old female vaccinee who developed a red, raised, hot to touch spot at the site of injection approximately 3 and a half hours after receiving Fluvirin on 03 November 2003 and also experienced 3 episodes of diarrhea on 04 November 2003. On 03 November 2003, the vaccinee developed a red, raised, hot to touch spot at the site of injection. The vaccinee did not experience any fever. The spot on the vaccinee's arm increased in size to approximately 3 inches in diameter and the soreness worsened. On 04 November 2003, the vaccinee experienced 3 episodes of diarrhea. Follow-up pending.									N	11/03/2003	11/03/2003	0		UNK	UNK					PJP20030093	1						1	Diarrhoea; Feeling hot; Injection site erythema; Injection site oedema; Injection site pain; Injection site swelling	FLU3~EVANS VACCINES~765712~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230443	12/09/2004					U	10/08/2004	Local pain (Injection site pain, injecton site pain)(Pain inject site) - recovered/resolved Local swelling (Injection site inflammation, injection site inflammation)(Inflam inject site) - recovered/resolved Local redness (Injection site reaction, injection site reaction)(Inject site react) - recovered/resolved A report was received from a health professional on 05 November 2003, concerning 44 vaccinees who all experienced local reactions at the injection site a day after receiving Fluvirin on 03 November 2003. On 04 November 2003, the vaccinees experienced local reactions at the injection site. No other information was available. There was insufficient information to determine the reporter's causality assessment. Update 1, 20 January 2004. A follow-up report was received from a health care professional concerning 20 to 30 vaccinees who developed local pain, local swelling and local redness after they received Fluvirin. The reporter indicated that all symtoms had resolved within 48 hours and there are no ongoing complaints.									Y	11/03/2003	11/03/2003	0		UNK	UNK					PJP200300994	1						1	Injection site erythema; Injection site inflammation; Injection site pain; Injection site swelling	FLU3~EVANS VACCINES~~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230444	12/09/2004		60.0	59		F	10/08/2004	Red patch at injection site- recovered/resolved Hot patch at injection site- recovered/resolved Itchy patch at injection site- recovered/resolved  A report was received from a health professional on 05 November 2003, concerning a 59 year old female vaccinee who developed a 6cm x 3cm red, hot and itchy patch at the site of injection the same evening after receiving Fluvirin vaccine on 04 November 2003. On 04 November 2003 the vaccinee developed a 6cm x 3cm red, hot and itchy patch at the site of injection. It was reported as being similar to an allergic reaction such as that observed during an allergy test. The rash was treated with a topical corticostaroid cream and the patient recovered on 05 November 2003. There was insufficient information to determine the reporter's causality assessment. Follow-up pending.									Y	11/04/2003	11/04/2003	0		UNK	UNK					PJP200300996	1						1	Feeling hot; Hypersensitivity; Injection site erythema; Pruritus; Rash	FLU3~EVANS VACCINES~~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230445	12/09/2004		41.0			F	10/08/2004	Red area (Rash, Rash) - not recovered/not resolved Itchy area (Pruritus, Pruritus)(Pruritus) - not recovered/not resolved Swollen (edema, Edema) (Edema) - not recovered/not resolved Tender (Pain, Pain) (Pain) - not recovered/ not resolved. A report was recieved from a health care professional on 5 November 2003 concerning a 41 year old female vaccinee who experienced a red, itchy area that was swollen and tender on the same day as receiving Fluvirin on 3 November 2003. On 3 November 2003 the vaccinee experienced a red, itchy area (40 x 60 mm) that was swollen and tender. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow-up pending.									N	11/03/2003	11/03/2003	0		UNK	UNK					PJP200300997	1						1	Erythema; Oedema; Pain; Pruritus; Rash; Swelling; Tenderness	FLU3~EVANS VACCINES~765141~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230446	12/09/2004		37.0			F	10/08/2004	A report was received from a health care professional on 5 November 2003 concerning a 37 year-old female vaccine who experienced a red, swollen area with hot spots on the same day as receiving Fluvirin on 4 November 2003.  On 4 November 2003 the vaccine experienced a red, swollen area with hot spots from shoulder to elbow.  the area was 10 x 10mm.  The vaccine had not recovered at the time of the report.  There was insufficient information to determine the reporter's causality assessment.  Follow up pending.									U		11/04/2003			UNK	UNK					PJP200300998	1						1	Erythema; Feeling hot; Oedema	FLU3~EVANS VACCINES~765141~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230447	12/09/2004		31.0			F		A report was received from a health care professional on 5 November 2003 concerning a 31 year old female vaccine who experienced a large red painful area on the same day as receiving Fluvirin on 4 November 2003.  On 4 November 2003 the vaccine experienced a experienced a large red painful area.  The vaccine had not recovered at the time of the report.  There was insufficient information to determine the reporter's causality assessment.  Follow up pending.									U	11/04/2003	11/04/2003	0		UNK	UNK					PJP200300999	1						1	Erythema; Pain	FLU3~EVANS VACCINES~765141~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230448	12/09/2004		36.0			F		A report was received from a health care professional on 5 November 2003 concerning a 36-year-old female vaccine who experienced a red, itchy area that was mildly painful on the same day as receiving Fluvirin on 4 November 2033.  On 4 November 2003 the vaccine experienced a red, itchy area that was mildly painful.  The vaccine had not recovered at the time of the report.  There was insufficient information to determine the reporter's causality assessment.  Follow up pending.									U	11/04/2003	11/04/2003	0		UNK	UNK					PJP200301000	1						1	Erythema; Pain; Pruritus	FLU3~EVANS VACCINES~765141~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230449	12/09/2004		66.0	66		M		A report was received from a health care professional on 5 November 2003 concerning a 65-year-old male vaccine who received expired Fluvirin on 1 October 2003.  On 1October 2003 the vaccine received expired Fluvirin.  There was insufficient information to determine the reporter's causality assessment.  Update 1, 16 February 2004.  A follow-up report was received from a health care professional indicating that the vaccine received Fluvirin on 02 October 2003.  No adverse event had occurred at the time of reporting.  No follow-up pending.  All information received.									U	10/01/2003	10/02/2003	1		UNK	UNK					PJP200301001	1						1	Medication error	FLU3~EVANS VACCINES~E31872GA~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230450	12/09/2004		45.0	45		F		A report was received from a health care professional on 5 November 2003 concerning a vaccine of unspecified demography who received expired Fluvirin on 1 October 2003.  On 1 October 2003 the vaccine received expired Fluvirin.  There was insufficient information to determine the reporter's causality assessment.  Update 1, 16 February 2004.  A follow-up report was received from a health care professional indicating that a 45 year old female vaccine received expired Fluvirin on 02 October 2003. No adverse event had occurred at the time of reporting.  No follow-up pending, all informaiton received.									U	10/01/2003	10/02/2003	1		UNK	UNK					PJP200301002	1						1	Medication error	FLU3~EVANS VACCINES~K31872GA~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230451	12/09/2004		53.0	52		M	10/08/2004	A report was received from a healthcare professional on 5 November 2003 concerning a vaccinee of unspecified demography who received expired Fluvirin on 1 October 2003. On 1 October 2003 the vaccinee received expired Fluvirin. There was insufficient information to determine the reporter's causality assessment. Update 1, 16 February 2004. A follow up report was received from a healthcare professional indicating that a 52 year old male vaccinee received expired Fluvirin on 02 October 2003.  No adverse event had occurred at the time reporting. No follow up pending, all information received.									U	10/02/2003	10/02/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200301003	1						1	Medication error	FLU3~EVANS VACCINES~K31872GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230452	12/09/2004		56.0			F	10/08/2004	A report was received from a healthcare professional on 5 November 2003 concerning a 56 year old female vaccinee who experienced a 3-4 inch red area around the injection site and itches on the same day as receiving Fluvirin on 4 November 2003. On 4 November 2003 the vaccinee experienced a 3-4 inch red area around the injection site and itches.  The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/04/2003	11/04/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200301004	1						1	Injection site erythema; Injection site hypersensitivity; Pruritus	FLU3~EVANS VACCINES~766049~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230453	12/09/2004		50.0			F	10/08/2004	A report was received from a healthcare professional on 5 November 2003 concerning a 50 year old female vaccinee who experienced a 3-4 inch red area which was itchy, painful and hot on the same day as receiving Fluvirin on a 4 November 2003. On 4 November 2003 the vaccinee experienced a 3-4 inch red area which was itchy, painful and hot.  The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/04/2003	11/04/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200301005	1						1	Erythema; Feeling hot; Pain; Pruritus	FLU3~EVANS VACCINES~766049~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230454	12/09/2004		73.0			F	10/08/2004	A report was received from a healthcare professional on 6 November 2003 concerning a 73 year old female vaccinee who received expired Fluvirin on 4 November 2003. On 4 November 2003 the vaccinee received expired vaccine.  No adverse event had occurred at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/04/2003	11/04/2003	0		UNK	UNK	Prilosec Asulfidine Lisinopril Synthroid Paxil Aricept		No risk factors reported. Hypertension, ulcerative colitis, hyperlipidemia		PJP200301007	1						1	Medication error	FLU3~EVANS VACCINES~E35742KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230455	12/09/2004		72.0	71		M	10/08/2004	A report was received from a healthcare professional on 6 November 2003 concerning a 71 year old male vaccinee who received expired Fluvirin on 4 November 2003. On 4 November 2003 the vaccinee received expired vaccine.  No adverse event had occurred at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/04/2003	11/04/2003	0		UNK	UNK	Prevacid Vioxx Lipitor		No risk factors reported. Seizures, hemochronatosis, arthritis.		PJP200301008	1						1	Medication error	FLU3~EVANS VACCINES~E35742KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230456	12/09/2004					U	10/08/2004	A report was received from a health care professional on 27 October 2003 concerning 3 vaccinees of unknown demography who experienced red, swollen arms an unspecified length of time after receiving Fluvirin vaccine on an unknown date. On an unknown date, the vaccinee's arms became red and swollen. The swelling ranged from the size of a golf ball to the size of a tennis ball. The outcome of the events was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200300897.									U					UNK	UNK					PJP200301009	1						1	Erythema; Oedema	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230457	12/09/2004		77.0			M	10/08/2004	A report was received from a health care professional on 6 November 2003 concerning a 77 year old male vaccinee who received expired Fluvirin on 5 November 2003. On 5 November 2003 the vaccinee received expired vaccine. No adverse event had occurred at the time of this report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200301007, PJP200301008,PJP200301011.									U	11/05/2003	11/05/2003	0		UNK	UNK					PJP200301010	1						1	Medication error	FLU3~EVANS VACCINES~E35742KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230458	12/09/2004		71.0			M	10/08/2004	A report was received from a health care professional on 6 November 2003 concerning a 71year old male vaccinee who received expired Fluvirin on 5 November 2003. On 5 November 2003 the vaccinee received expired vaccine. No adverse event had occurred at the time of this report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200301007, PJP200301008,PJP200301010.									U	11/05/2003	11/05/2003	0		UNK	UNK	Lipitor, Naproxen, Synthroid, Rocaltrol, and Vitamin D.		Hypocalcemia, hypothyroidism, hyperlipidemia		PJP200301011	1						1	Medication error	FLU3~EVANS VACCINES~E35742KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230459	12/09/2004		24.0			F	10/08/2004	A report was received from a health care professional on 6 November 2003 concerning a 24 year old female vaccinee who experienced redness and warmth at the injection site 2 days after receiving Fluvirin on 3 November 2003. On 5 November 2003 the vaccinee experienced redness and warmth at the injection site. The vaccinee had not recovered at the time of this report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200301013.									U	11/03/2003	11/05/2003	2		UNK	UNK					PJP200301012	1						1	Injection site erythema; Injection site warmth	FLU3~EVANS VACCINES~765754~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230460	12/09/2004		25.0			F	10/08/2004	A report was received from a health care professional on 6 November 2003 concerning a 25 year old female vaccinee who experienced redness and warmth at the injection site 1 day after receiving Fluvirin on 5 November 2003. On 6 November 2003 the vaccinee experienced redness and warmth at the injection site. The vaccinee had not recovered at the time of this report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200301012.									U	11/05/2003	11/06/2003	1		UNK	UNK					PJP200301013	1						1	Injection site erythema; Injection site warmth	FLU3~EVANS VACCINES~765754~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230461	12/09/2004					U	10/08/2004	A report was received from a health professional on 11/06/03, concerning a vaccinee of unspecified demography who received an unspecified brand of flu vaccine on 10/20/03 and inadvertently received Fluvirin on 11/06/2003. At the time of the repot the vaccinee had not experienced any adverse reactions. No other information was available at the time of report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/06/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200301014	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230462	12/09/2004					U	10/08/2004	A report was received from a health professional on 11/06/03, concerning approximately 30 elderly vaccinees who inadvertently received Fluvirin subcutaneously on 11/06/03. No other information was available at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/06/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200301015	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230463	12/09/2004					U	10/08/2004	A report was received from a health professional on 11/06/2003, concerning approximately 20-30 vaccinees who developed a warm, red and sore spot at the site of injection. This occurred approximately 24-48 hours after they received Fluvirin on 11/04/03 or 11/05/03. On 11/06/03 the vaccinees developed a warm, red sore spot about the size of a silver dollar at the site of injection. The reporter described the reaction as cellulitis and attributed it to the short needle length of the prefilled syringe. There was insufficient information to determine the reporter's causality. Follow up pending.									U					UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200301016	1						1	Medication error	FLU3~EVANS VACCINES~765751~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230464	12/09/2004		67.0	66		M	10/08/2004	A report was received from a health professional on 11/06/03, concerning a 66 year old vaccinee who experienced localized redness at the injection site two days after receiving Fluvirin on 10/30/03. On 11/01/03, the vaccinee experienced localized redness about 10mm in diameter at the injection site. There was no other symptoms. The event had not resolved at the time of report and the vaccinee is seeing his physician for a follow up visit. The vaccinee has previously had the flu vaccine without any such reaction. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/08/2003: Follow up information received from a health care professional indicated that on 11/06/03, the vaccinee experienced irritation and redness at the injection site and appeared to have a large scab. The vaccinee was admitted into the monitoring area. On 11/10/03, the vaccinee informed his doctor that the large scab was in fact a tick. The tick was removed on the same day and there were no further problems. The redness resolved on 11/10/03. No follow up pending.				Y					U	10/30/2003	11/01/2003	2		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported. Received Flu vaccine in the past without any reaction.		PJP2003001017	1						1	Injection site erythema; Skin irritation	FLU3~EVANS VACCINES~765179~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0230465	12/09/2004		1.92	1	.9	M	10/08/2004	A report was received from a health care professional on 11/06/03, concerning a 2 year old male vaccinee who received Fluvirin on 11/06/03. On 11/06/03, the vaccinee received a single of dose of Fluvirin intramuscularly. At the time of reporting the vaccinee did not exhibit any adverse symptoms from the vaccination. There was insufficient information to determine the reporter's causality assessment. Update 1, 05/10/04: Follow up information received from a health care professional indicated that the 2 year old vaccinee developed emesis and a temperature of 100.9 several hours after receiving Fluvirin on 11/06/03. Both events resolved on an unspecified date. The reporter indicated that the emesis and elevated temperature were possibly unrelated as when the patient was later examined he did have tonsillar hypertrophy without a high temperature. On 12/29/03, the patient tested positive for Influenza A. It was not reported if the vaccinee had recovered from the tonsillar hypertrophy and the Influenza A at the time of the report. There was insufficient information to determine the causality of the tonsillar hypertrophy and the Influenza A. Follow up pending.				Y					U	11/06/2003	11/06/2003	0		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200301018	1						1	Drug ineffective; Hypertrophy; Influenza; Medication error; Pyrexia; Respiratory disorder; Vomiting	FLU3~EVANS VACCINES~765670~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0230466	12/09/2004		74.0			F	10/08/2004	A report was received from a health care professional on 11/06/03, concerning a 74 year old female who experienced cellulitis with erythema, bruising and warmth on the same day as possibly receiving Fluvirin subcutaneously on 10/27/03. On 10/27/03 the vaccinee experienced erythema and bruising, (10x12 cm) on the affected upper extremity from shoulder to elbow. No rash was present, but the area was warm to touch. This event was labeled by the treating physician as possible cellulitis versus possible allergic reaction. The vaccinee was treated with cephalexin and cetirizine hydrochloride. The event was much improved but not completely resolved at the time of reporting. It was believed that the vaccinee had been administered subcutaneously. There was insufficient information to determine the reporter's causality assessment. Follow up pending.				Y					U	10/27/2003	10/27/2003	0		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200301019	1						1	Cellulitis; Contusion; Erythema; Feeling hot; Hypersensitivity; Medication error	FLU3~EVANS VACCINES~765796~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0230467	12/09/2004		2.0			F	10/08/2004	A report received from a health care professional on 11/06/03, concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 11/04/03. No adverse event was reported at the time of the report. There was insufficient information to determine the reporters causality assessment. Follow up pending.									U	11/04/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200301020	1						1	Medication error	FLU3~EVANS VACCINES~765958~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230468	12/09/2004		1.57	1	.6	M	10/08/2004	A report was received from a health care professional on 11/07/03, concerning an 18 month old male vaccinee who inadvertently received Fluvirin on 11/07/03. On 11/07/03 the vaccinee received a single dose of Fluvirin, 0.25ml. At the time of reporting the vaccinee did not exhibit any adverse symptoms. There was insufficient information to determine the reporter's causality assessment. Update 1, 01/07/04: Further information was received from a health care professional on 01/07/04 indicating that the vaccinee did not experience any adverse reaction. No follow up pending, all information received.									U	11/07/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200301022	1						1	Medication error	FLU3~EVANS VACCINES~765971~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230469	12/09/2004					U	10/08/2004	A report was received from a health care professional on 11/07/03, concerning two vaccinees who developed local skin reactions at the site of injection, involving a red patch 3-4 inches wide, after receiving an unspecified brand of influenza vaccine on an unspecified date. On an unspecified date, the vaccinees developed a red patch 3-4 inches wide at the site of injection. No other information was available at the time of the report and the outcome was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200301023	1						1	Injection site erythema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0230470	12/09/2004					U	10/08/2004	A report was received from a health care professional on 11/07/03, concerning a vaccinee of unknown demography who experienced pain at the injection site for more than 2 days after receiving Fluvirin vaccine on 11/03/03. The outcome of the event was not reported. There was insufficient information to determine the reporters causality assessment. Follow up pending.									U	11/03/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200301024	1						1	Injection site pain	FLU3~EVANS VACCINES~765954~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230471	12/09/2004		25.0	25		F	10/08/2004	A report was received from a health care professional on 11/07/2003, concerning a 25 year old female vaccinee who developed a metallic taste in her mouth approximately 20 minutes after receiving Fluvirin vaccine on 11/7/03. The vaccinee recovered on 11/07/03. There was insufficient information to determine the reporter's causality assessment. Update 1, 01/09/04: Further information was received from a health care professional on 01/09/04 indicating that the vaccinee developed a metallic taste 10 minutes following vaccination and experienced a feeling of warmth 5-10 minutes following vaccination. The vaccinee's symptoms have resolved. Follow up pending.									Y	11/07/2003	11/07/2003	0		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200301025	1						1	Dysgeusia; Feeling hot	FLU3~EVANS VACCINES~765412~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230472	12/09/2004		37.0			F	10/08/2004	A report was received from a health care professional on 11/07/03, concerning a 37 year old female vaccinee who experienced flu like symptoms consisting of general achiness, lethargy, headache, low grade fevers, congestion and coughing approximately two weeks after receiving Fluvirin vaccine on an unknown day in October 2003. The vaccinee was seen in a physicians office on 11/07/03 and she appeared to be doing well. There was insufficient information to determine the reporter's causality assessment. Update 1, 02/24/2004: Follow up information received from a health care professional indicated that an influenza test revealed a positive result. The patient was treated with Amantadine and recovered with conservative treatment. No follow up pending.				Y					Y					UNK	UNK	Serevent, Synthroid, Flovent and Amantadine		No risk factors reported. Turner's Syndrome, Mitral Valve repair 06/23/2003		PJP200301026	1						1	Cough; Drug ineffective; Headache; Influenza like illness; Lethargy; Nasal congestion; Pain; Pyrexia	FLU3~EVANS VACCINES~765878~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0230473	12/09/2004		62.0	62		F	10/08/2004	A report was received from a health care professional on 11/07/2003, concerning a vaccinee of unspecified demography who received Fluvirin on 11/06/03. After receiving the influenza vaccine (brand unspecified) approximately two weeks earlier on an unknown date. No adverse effects were reported from the initial vaccination. There was insufficient information to determine the reporter's causality assessment. Update 1, 01/26/04: A follow up report was received from a health care professional who confirmed that the vaccinee was 62 year old female who did not experience any adverse event. Update 2, 04/06/04: Further information was received from a health care professional providing the batch of the Fluvirin administered. No follow up pending, all information received.									U	11/06/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200301027	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~765873~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230474	12/09/2004		3.0	2	.7	F	10/08/2004	A report was received from a health care professional on 11/07/03, concerning a 33 month old female vaccinee who advertently received Fluvirin on 11/7/03. On 11/7/03 the vaccinee received a single dose of Fluvirin 0.5ml. At the time of reporting the vaccinee did not exhibit any adverse symptoms. There was insufficient information to determine the reporters causality assessment. Update 1, 01/24/04: A follow up report was received from a health care professional indicating that no adverse reactions were reported, at the time of reporting. No follow up pending, all information received.									U	11/07/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200301028	1						1	Medication error	FLU3~EVANS VACCINES~765979~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230475	12/09/2004		81.0	80		F	10/08/2004	A report was received from a health care professional on 11/08/03, concerning an 88 year old female vaccinee who inadvertently received a second dose of Fluvirin on 11/07/03. On 11/04/03, an 88 year old female vaccinee was administered 0.5mls Fluvirin. Subsequently on 11/7/03, the vaccinee received a further dose of 0.5mls of Fluvirin. The vaccinee did not exhibit any untoward sings or symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1, 02/16/04: A follow up report was received from a health care professional indicating that there was no adverse events experienced by the vaccinee. No follow up pending, all information received.									U	11/07/2003				UNK	UNK	Celebrex 03/14/03 200 mg (200mg, 1 in 1D) Lipitor 12/19/03-01/23/04 10mg (10mg,1 in 1D), Trazodone 05/24/01 0.25mg (0.25mg, once at bedtime), Lortab 07/08/03 7.5/500 mgs once in morning		No risk factors reported. Diabetes, Hypertension and Glaucoma.		PJP200301029	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~765855~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230477	12/09/2004		48.0	47		F	10/08/2004	A report was received from a health care professional on 11/7/04, concerning a 47 year old female vaccinee who experienced lymphadenopathy, malaise and a feeling of warmth, 18 hours following the inadvertent administration of expired Fluvirin vaccine on 11/3/03. On 11/5/03, the vaccinee experienced lymphadenopathy, malaise and a feeling of warmth. A description on the clinical symptoms given included swollen and tender lymph nodes behind the ear, under the clavicle, on the left side of the neck and in the vaccinee's left hip. The vaccinee also had constitutional symptoms of malaise and a feeling of warmth. The reporter thinks the vaccinee's symptoms have worsened slightly. An ER physician examined her and stated she was OK. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/23/2003: A follow up report was received from a health care professional indicating that the vaccinee had developed the following adverse experiences on 11/5/2003: Lymph node swelling and left neck swelling that had not resolved at the time of the follow up report. Left arm swelling and pain which were slowly resolving at the time of the follow up report. Left arm pain and left hip pain, which had both resolved at the time of the follow up report. An ER physician checked the vaccinee and said he wasn't sure but felt it probably was due to the influenza vaccine. Update 2, 02/03/04: A follow up report was received from a health care professional indicating that the vaccinee's left lymphadenopathy subsided total on 01/20/04. The reporter reported that the vaccinee has not experienced any further sequelae. No follow up pending, all information received.				Y					U	11/03/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200301031	1						1	Feeling hot; Lymphadenopathy; Malaise; Medication error; Pain; Swelling	FLU3~EVANS VACCINES~765751~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0230478	12/09/2004		3.0			M	10/08/2004	A report was received from a health care professional on 11/10/03 concerning a 3 year old male vaccinee who inadvertently received Fluvirin on 10/20/03. On 10/20/03 , the vaccinee received a single dose of Fluvirin 0.5ml. At the time of reporting the vaccinee did not exhibit any adverse effects. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference: PJP200301187, PJP200301185, PJP200301184, PJP200301182, PJP200301180, PJP200301179, PJP200301177, PJP200301176, PJP200301175, PJP200301174, PJP200301172.									U	10/20/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200301033	1						1	Medication error	FLU3~EVANS VACCINES~765667~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230479	12/09/2004					U	10/08/2004	A report was received from a health care professional on 11/10/03, concerning a vaccinee of unspecified demography who received a second dose of Fluvirin 3 weeks after receiving the first dose on an unspecified date. On an unspecified date, the vaccinee was inadvertently administered a second dose of Fluvirin. No adverse events were reported at the time of report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	Concomitant Drug Not reported		No risk factors reported.		PJP200301035	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~765502~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230480	12/09/2004		88.0			F	10/08/2004	A report was received from a health care professional on 11/10/03, concerning an 88 year old female vaccinee who received a dose of Fluvirin on 10/16/03 and inadvertently received a second dose on 11/10/03. No adverse events were reported at the time of report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/10/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200301036	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~765855~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230481	12/09/2004					U	10/08/2004	A report was received from a health care professional on 11/10/03, concerning a vaccinee who was less than 4 years of age and of unknown gender, that inadvertently received Fluvirin on an unknown date. The reporter did not have information on whether an adverse event had occurred. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200301037	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230482	12/09/2004		55.0	54		F	10/08/2004	A report was received from a health care professional on 10 November 2003, concerning a 54 year old female vaccinee who experienced Labyrinth's disease one day after receiving Fluvirin on 29 October 2003. On the morning of 30 October 2003, the vaccinee experienced dizziness. Her physician diagnosed Labyrinth's Disease. The vaccinee has never previously experienced episodes of dizziness. The vaccinee was treated with fexofenadine, 180mg daily. On 07 November 2003, the vaccinee's condition had improved. However, she was continuing to have short periods of vertigo several time a day, with positions changes. The reporter has assessed the relationship of the Fluvirin to the event as unrelated. Follow up pending.									Y	10/29/2003	10/30/2003	1		UNK	UNK	Hydrochlorothiazine				PJP200301038	1						1	Dizziness	FLU3~EVANS VACCINES~765139~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230483	12/09/2004		3.0	2	.7	M	10/08/2004	A report was received from a health care professional on 10 November 2003 concerning a 2 year old male vaccinee who inadvertently received Fluvirin on 10 November 2003. On 10 November 2003 the vaccinee inadvertently received 0.5 ml Fluvirin. It was not reported whether or not an adverse event had occurred. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200301040. Update 1, 06 January 2004. A follow up report was received form a health care professional indicating that no adverse effects were experienced by the vaccine at the time of the follow up report. No follow up pending.									U	11/10/2003	11/10/2003	0		UNK	UNK					PJP200301039	1						1	Medication error	FLU3~EVANS VACCINES~767667~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230484	12/09/2004		3.0	3		F	10/08/2004	A report was received from a health care professional on 10 November 2003 concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 10 November 2003. On 10 November 2003 the vaccinee inadvertently received 0.5 ml Fluvirin. It was not reported whether or not an adverse event had occurred. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200301039. Update 1, 06 January 2004. A follow up report was received from a health care professional indicating that no adverse effects were experienced by the vaccinee at the time of the follow up report. No follow up pending.									U	11/10/2003	11/10/2003	0		UNK	UNK					PJP200301040	1						1	Medication error	FLU3~EVANS VACCINES~767667~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230485	12/09/2004		1.19	1	.2	M	10/08/2004	A report was received from a health care professional on 10 November 2003 concerning a male vaccinee less than 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date the vaccinee inadvertently received 0.25 ml Fluvirin. The vaccine had not experienced any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update report: 13 January 2004. Follow up information received from a health care professional indicated that a 14 month old male vaccinee inadvertently received Fluvirin on 27 October 2003 and had not experienced any adverse reaction. Follow up pending. Cross reference with PJP200301042.									U	10/27/2003	10/27/2003	0		UNK	UNK					PJP200301041	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230486	12/09/2004		2.0	2	.4	M	10/08/2004	A report was received from a health care professional on 10 November 2003 concerning a male vaccinee less than 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date the vaccinee inadvertently received 0.25 ml Fluvirin. The vaccine had not experienced any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update report: 13 January 2003. Follow up information received from a health care professional indicated that a 28 month old male vaccinee inadvertently received Fluvirin on 27 October 2003 and had not experienced no adverse event as a result. Follow up pending. Cross reference with PJP200301041.									U	10/27/2003	10/27/2003	0		UNK	UNK					PJP200301042	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230487	12/09/2004		1.94	1	.9	M	10/08/2004	A report was received from a health care professional on 20 October 2003 concerning an unspecified number of vaccinees less than 4 years of age who received Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received Fluvirin. The reporter was not aware of any of adverse symptoms occurring at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 10 November 2003: A follow up report was received from a health care professional indicating that a 2 year old male vaccinee received Fluvirin on 7 October 2003. Cross reference with PJP200300839.									U	10/07/2003	10/07/2003	0		UNK	UNK					PJP200301043	1						1	Medication error	FLU3~EVANS VACCINES~765705~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230488	12/09/2004					U	10/08/2004	A report was received from a health care professional on 07 November 2003, concerning several vaccinees who experienced soreness, redness, swelling and itching at the site of injection after an unspecified length of time after receiving Fluvirin on unspecified dates in October and November 2003. On unspecified dates in October and November 2003 the vaccinees experienced soreness, redness, swelling and itching at the injection site. The swelling was described as the size of a small orange, raised, red and hard. The outcome of the events was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK					PJP200301044	1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site pain; Injection site reaction; Injection site swelling; Pruritus	FLU3~EVANS VACCINES~765876~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230489	12/09/2004					U	10/08/2004	A report was received from a health care professional on 11 November 2003 concerning 2 vaccinees of unknown demography who were inadvertently administered frozen Fluvirin vaccine on 11 November 2003. On 11 November 2003 2 vaccinees inadvertently received Fluvirin which had been frozen. At the time of the report the outcome was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/11/2003	11/11/2003	0		UNK	UNK					PJP200301045	1						1	Medication error	FLU3~EVANS VACCINES~765796~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230490	12/09/2004		94.0			F	10/08/2004	A report was received from a health care professional on 11 November 2003, concerning an unspecified number of vaccinees who inadvertently received 1 ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1 ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 4 December 2003. An update report was received from a health care professional concerning a 94 year old female vaccinee who inadvertently received 1 ml of Fluvirin subcutaneously on 31 October 2003. No adverse symptoms were exhibited at the time of reporting. Follow up pending. Cross reference with: PJP200301345, PJP200301332, PJP200301333, PJP200301334, PJP200301335, PJP200301336, PJP200301337, PJP200301338, PJP200301339, PJP200301340, PJP200301341, PJP200301342, PJP200301343, and PJP200301344.									U	10/31/2003	10/31/2003	0		UNK	UNK					PJP200301046	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~765795~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230491	12/09/2004		52.0			F	10/08/2004	A report was received from a health care professional on 11 November 2003 concerning a 52 year old female vaccinee who experienced localized redness an unspecified length of time after inadvertently receiving a sub-optimal dose of Fluvirin intradermally on 11 November 2003. On 11 November 2003 the vaccinee received 0.1 ml Fluvirin intradermally. The vaccinee experienced injection site redness shortly after vaccination. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 25 November 2003: Follow up information received from a health care professional indicated that the vaccinee also experienced localized tenderness on 11 November 2003. The vaccinee recovered on 18 November 2003. Cross reference with: PJP200301050, PJP200301051.									Y	11/11/2003	11/11/2003	0		UNK	UNK					PJP200301049	1						1	Injection site erythema; Medication error; Tenderness	FLU3~EVANS VACCINES~765704~UNK~ID~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230492	12/09/2004		47.0			F	10/08/2004	A report was received from a health care professional on 11/11/03 concerning a 47 year old female vaccinee who experienced localized redness an unspecified time after inadvertently receiving a sub optimal dose of Fluvirin intradermally on 11/11/03. On 11/11/03 the vaccinee received 0.1ml Fluvirin intradermally. The vaccinee experienced injection site redness shortly after vaccination. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 11/25/03: Follow up information received from a health care professional indicated that the vaccinee also experienced localized tenderness. The vaccinee recovered 6 days after the onset of the event. Cross reference with: PJP200301051 amd PJP200301049.									U	11/11/2003	11/11/2003	0		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200301050	1						1	Injection site erythema; Injection site pain; Medication error	FLU3~EVANS VACCINES~765704~UNK~ID~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230493	12/09/2004		35.0			M	10/08/2004	Localized redness (Injection site reaction, injection site reaction)(Inject site react) - recovered/resolved Localized tenderness (Injection site pain, Injection site pain)(pain inject site) - recovered/resolved Received sub-optimal dose (Medication error, medication error)(Med error) - not reported Administration by an unlicensed route (Medication error, medication error) (Med error) - not reported A report was received from a health care professional on 11 November 2003 concerning a 35 year old male vaccinee who experienced localized redness an unspecified length of time after inadvertently receiving a sub-optimal dose of Fluvirin intradermally on 11 November 2003. On 11 November 2003 the vacinee received 0.1ml Fluvirin intradermally. The vaccinee experinced injection site redness shortly after vaccination. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1 25 November 2003 Follow-up information recieved from a health care professional indicated that the vacinee also experienced localized tenderness on 11 November 2003. The vacinee recovered on 17 November 2003.									N	11/11/2003	11/11/2003	0		UNK	UNK					PJP200301051	1						1	Injection site erythema; Injection site pain; Medication error; Tenderness	FLU3~EVANS VACCINES~765704~2~ID~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230494	12/09/2004		39.0			F	10/08/2004	Swelling (Edema, edema)(Edema) - recovered/resolved Redness (Rash, rash)(Rash) - recovered/resolved Warmth (Vasodilatation, Vasodilatation)(Vasodilat) - recovered/resolved Pain (Pain, Pain)(Pain) - recovered/resolved A report was received from an office manager on 11 November 2003 concerning a female vaccinee in her 30's who experienced swelling, redness, warmth and pain on the same day as receiving Fluvirin on 10 November 2003. On 10 November 2003 the vaccinee experienced swelling, redness, warmth and pain. The pain had been becoming milder at the time of the report. The vaccinee had not recovered at the time of the report. Update 1. 25 November 2003: Further information was recevied from an office manager on 25 November 2003 indicating that the swelling, redness, warmth and pain experienced by the 39 year old female vaccinee resolved 3 days after onset, on 13 November 2003. There was insufficient information to determine the reporter's causalty assessment. No follow-up pending.									Y	11/10/2003	11/10/2003	0		UNK	UNK					PJP200301052	1						1	Erythema; Feeling hot; Oedema; Pain; Rash; Swelling; Vasodilatation	FLU3~EVANS VACCINES~766053~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230495	12/09/2004		23.0			F	10/08/2004	Swelling (Edema, Edema)(Edema) - recovered/resolved Redness (Rash, rash)(Rash) - recovered/resolved Warmth (Vasodilatation, vasodilatation)( Vasodilat) - recovered/resolved Pain (Pain, pain)(Pain) - recovered/resolved A report was received from an office manager on 11 November 2003 concerning a female vaccinee in her 20's who experienced swelling, redness, warmth and pain on the same day as receiving Fluvirin on 10 November 2003. On 10 November 2003 the vaccinee experienced swelling, redness, warmth and pain. The pain had been becoming milder at the time of the report. The vaccinee had not recovered at the time of the report. Update 1, 25 November 2003: Further information was received from an office manager on 25 November 2003 indicating that the swelling, redness, warmth and pain experienced by the 23 year old female vaccinee resolved 2 days after onset, on 12 November 2003. There was insufficient information to determine the reporter's causality assessment. No follow up pending.									Y	11/10/2003	11/10/2003	0		UNK	UNK					PJP200301053	1						1	Erythema; Feeling hot; Oedema; Pain; Rash; Swelling; Vasodilatation	FLU3~EVANS VACCINES~766053~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230496	12/09/2004		46.0			F	10/08/2004	Swelling (Edema, edema)(Edema) - recovered/resolved Redness (rash, rash)(Rash) - recovered/resolved Warmth (Vasodilatation, vasodilatation)(Vasodilat) - recovered/resolved Pain (Pain, pain)(Pain) - recovered/resolved A report was received from an office manager on 11 November 2003 concerning a female vaccinee in the 30's who experienced swelling, redness, warmth and pain on the same day as receiving Fluvirin on 10 November 2003. On 10 November 2003 the vaccinee experienced swelling, redness, warmth and pain. The pain had been becoming milder at the time of the report. The vaccinee had not recovered at the time of the report.  Update 1, 25 November 2003: Further information was received from an office manager on 25 November 2003 indicating that the swelling, redness, warmth and pain experienced by the 46 year old female vaccinee resolved 3 days after onset, on 13 November 2003. There was insufficient information to determine the reporter's causality assessment. No follow up pending.									Y	11/10/2003	11/10/2003	0		UNK	UNK					PJP200301054	1						1	Erythema; Feeling hot; Oedema; Pain; Rash; Swelling; Vasodilatation	FLU3~EVANS VACCINES~766053~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230497	12/09/2004		33.0			F	10/08/2004	Swelling (Edema, edema)(Edema) - recovered/resolved Redness (Rash, rash)(Rash) - recovered/resolved Warmth (Vasodilatation, vasodilatation)(Vasodilat) - recovered/resolved Pain (Pain, pain)(Pain) - recovered/resolved A report was received from an office manager on 11 November 2003 concerning a female vaccinee in her 30's who experienced swelling, redness, warmth and pain on the same day as receiving Fluvirin on 10 November 2003. On 10 November 2003 the vaccinee experoenced swelling, redness, warmth and pain. The pain had been becoming milder at the time of the report. The vaccinee had not recovered at the time of the report. Update 1, 25 November 2003: Further information was received from an office manager on 25 November 2003 indicating that the swelling, redness, warmth and pain experienced by the 33 year old female vaccinee resolved 4 days after onset, on 14 November 2003. There was insufficient information to determine the reporter's causality assessment. No follow up pending.									Y	11/10/2003	11/10/2003	0		UNK	UNK					PJP200301055	1						1	Erythema; Feeling hot; Oedema; Pain; Rash; Swelling; Vasodilatation	FLU3~EVANS VACCINES~766053~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230498	12/09/2004		0.82	0	.8	M		A report was received from a health care professional on 12 November 2003, concerning a 9-month-old male vaccine who inadvertently received a second dose of Fluvirin on 12 November 2003.  On 12 November 2003, a 9-month-old male vaccine received a second dose of 0.25mls Fluvirin intramuscularly.  The dates of administration and dosage of the first dose were unspecified.  At the time of reporting the vaccine did not exhibit any adverse symptoms.  There was insufficient information to determine the reporter's causality assessment.  Follow-up pending.									U	11/12/2003	11/12/2003	0		UNK	UNK					PJP200301056	1						1	Medication error	FLU3~EVANS VACCINES~765704~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230499	12/09/2004					U		A report was received from a health care professional on 12 November 2003, concerning a number of vaccine who inadvertently received 2 doses of Fluvirin on unspecified date.  On unspecified dates, within approximately a one-month period the vaccine received 2 doses of Fluvirin.  No adverse symptoms were exhibited at the time of reporting.  There was insufficient information to determine the reporter's causality assessment.  Follow-up pending.									U					UNK	UNK					PJP200301057	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230500	12/09/2004					M		A report was received from a health care professional on 12 November 2003, concerning a male vaccine of unspecified age who experienced a sharp pain under his left shoulder blade on the evening of administration, and numbness in his entire left arm the following day after receiving Fluvirin on 11 November 2003.  On 11 November 2003, the vaccine received Fluvirin 0.5ml intramuscularly to left deltoid.  The vaccine developed a sharp pain under his left shoulder blade.  On 12 November 2003, the vaccine experienced numbness in his entire left arm.  According to the reporter the pain under the shoulder blade has subsided currently but the numbness is still ongoing.  There was insufficient information to determine the reporter's causality assessment.  Follow-up pending.									U		11/11/2003			UNK	UNK					PJP200301058	1						1	Hypoaesthesia; Injection site pain	FLU3~EVANS VACCINES~~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230501	12/09/2004		1.5			F		A report was received from a health care professional on 12 November 2003, concerning a 17-month-old female vaccine who inadvertently received Fluvirin on 11 November 2003.  On 11 November 2003, the vaccine inadvertently received Fluvirin 0.25ml intramuscularly.  The vaccine did not experience any adverse symptoms at the time of reporting.  There was insufficient information to determine the reporter's causality assessment.  Update 1, 23 February 2004.  A follow-up report was received from a health care professional indicating that the vaccine inadvertently received 0.5ml Fluvirin.  No adverse event had occurred at the time of reporting.  No follow-up pending, all information received.									U		11/11/2003			UNK	UNK					PJP200301060	1						1	Medication error	FLU3~EVANS VACCINES~765753~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230502	12/09/2004		2.0			F	10/08/2004	A report was received from a health care professional on 12 November 2003, concerning a 23-month-old female vaccine who inadvertently received Fluvirin on 12 November 2003.  On 12 November 2003, the vaccine inadvertently received Fluvirin intramuscularly.  The vaccine did not experience any adverse symptoms at the time of reporting.  There was insufficient information to determine the reporter's causality assessment.  Follow-up pending.									U		11/12/2003			UNK	UNK					PJP200301061	1						1	Medication error	FLU3~EVANS VACCINES~765799~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230503	12/09/2004		2.0	2	.2	F	10/08/2004	A report was received from a health care professional on 12 November 2003, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on an unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin intramuscularly. The vaccinees did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1, 07 January 2004. A follow up report was received from a health care professional concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 12 November 2003. On 12 November 2003, the vaccinee inadvertently received Fluvirin. The vaccinee did not experience any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report master file. Cross reference with: PJP200400063, PJP200400064, PJP200400065, PJP200400066, PJP200400067, PJP200400068, PJP200400069, PJP200400070, PJP200400071, PJP200400072, PJP200400073, PJP200400074, PJP200400075, PJP200400076, PJP200400077, PJP200400078, PJP200400079.									U	11/12/2003	11/12/2003	0		UNK	UNK					PJP200301062	1						1	Medication error	FLU3~EVANS VACCINES~765795~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230504	12/09/2004					U	10/08/2004	A report was received from a health care professional on 12 November 2003, concerning an unspecified number (approximately 12-24) of vaccinees who inadvertently received 1 ml Fluvirin on an unspecified date. On an unspecified date, an unspecified number of vaccinees inadvertently received 1 ml Fluvirin intramuscularly. The vaccinees did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment.  Update 1, 02 January 2004. A follow up report was received from a health care professional concerning a 22 vaccinees who inadvertently received 1ml Fluvirin on 13 November 2003. No adverse effects were experienced at the time of reporting. No follow up pending.									U	11/13/2003	11/13/2003	0		UNK	UNK					PJP200301063	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~765854~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230505	12/09/2004					U	10/08/2004	A report was received from a health care professional on 12 November 2003, concerning approximately 60 vaccinees who may have inadvertently received an expired influenza vaccine (brand unspecified) on an unspecified date. On an unspecified date approximately 60 vaccinees may have inadvertently received expired influenza vaccines. There was no information regarding adverse symptoms exhibited by the vaccines at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK					PJP200301064	1						1	Medication error	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0230506	12/09/2004		1.0			F	10/08/2004	A report was received from a health care professional on 12 November 2003, concerning an unknown number of vaccinees under 4 years of age who have inadvertently received Fluvirin on an unspecified date. On an unspecified date, an unspecified number of vaccinees under 4 years of age inadvertently received Fluvirin. No information was available at the time of reporting regarding the exhibition of adverse symptoms by the vaccinees. There was insufficient information to determine the reporter's causality assessment. Follow up received on 05 July 2004 confirming 10 children under the age of 4 years of age had been inadvertently administered Fluvirin instead of the product approved for pediatric use in the USA. This case involves a 22 month old female who inadvertently received Fluvirin on 04/Nov/2003. The vaccinee did not experience any adverse effects. No further information is expected. X-ref: CVOX200400231 to 00239.									U	11/04/2003	11/04/2003	0		UNK	UNK					PJP200301065	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230507	12/09/2004		51.0			F	10/08/2004	A report was received from a health care professional on 12 November 2003, concerning a 51 year old female vaccinee who inadvertently received expired Fluvirin on 11 November 2003. On 11 November 2003, the vaccinee inadvertently received 0.5 ml of expired Fluvirin. The vaccinee did not exhibit any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/11/2003	11/11/2003	0		UNK	UNK					PJP200301066	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230508	12/09/2004		0.94	0	.9	M	10/08/2004	A report was received from a health care professional on 14 October 2003 concerning an unspecified number of vaccinees less than 4 years of age who received Fluvirin subcutaneously on an unspecified date. On an unspecified date an unspecified number of vaccinees under 4 years of age received Fluvirin subcutaneously. The reporter indicated the the exact number of vaccinees was unknown but was believed to be less than 20 vaccinees. Vaccinees aged between 6 and 35 months were given 0.25 ml and 0.5 ml was given to vaccinees greater than 35 months. No adverse symptoms had been noted. Update 1, 07 November 2003. A follow up report was received from a consumer indicating that an 11 month old male vaccinee inadvertently received Fluvirin on 10 October 2003. No adverse reaction had occurred at the time of the report. Cross reference with: PJP200300808.									U	10/10/2003	10/10/2003	0		UNK	UNK					PJP200301068	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230509	12/09/2004		54.0			F	10/08/2004	A report was received from a health care professional on 12 November 2003 concerning a 52 year old female vaccinee who experienced loss of peripheral vision after receiving Fluvirin on 06 November 2003. On 06 November 2003 a female vaccinee received a single dose of Fluvirin, and that night the vaccinee experienced loss of peripheral vision. the loss of vision was due to a choked optic nerve as per an ophthalmologist and an eye care specialist. There was insufficient information to determine the reporter's causality assessment. Follow up pending.				Y					U					UNK	UNK					PJP200301069	1						1	Visual field defect	FLU3~EVANS VACCINES~765959~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0230510	12/09/2004					U	10/08/2004	A report was received from a health care professional on 13 November 2003 concerning a vaccinee who inadvertently received 2 doses of Fluvirin on an unspecified date. On an unspecified date the vaccinee inadvertently received 2 doses of Fluvirin. The vaccinee did not experience any adverse symptoms at the time of reporting.  There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK					PJP200301070	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230511	12/09/2004					U	10/08/2004	A report was received from a health care professional on 13 November 2003, concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date, the vaccinees inadvertently received 0.25 ml of Fluvirin. The vaccinees did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK					PJP200301071	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230512	12/09/2004					U	10/08/2004	A report was received from a health care professional on 13 November 2003, concerning three vaccinees of unknown demography who inadvertently received expired Fluvirin on an unspecified date. On an unspecified date the vaccinees inadvertently received expired Fluvirin. The vaccinees did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK					PJP200301072	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230513	12/09/2004		87.0			F	10/08/2004	A report was received from a health care professional on 13 November 2003 concerning an 87 year old female vaccinee who inadvertently received 2 doses of Fluvirin on unspecified dated, over a period of a couple of days. On unspecified dates, the vaccinee inadvertently received 2 doses of Fluvirin over a period of a couple of days. No adverse symptoms were reported at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK					PJP200301073	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230514	12/09/2004					U	10/08/2004	A report was received from a health care professional on 13 November 2003 concerning an unspecified number of vaccinees less than 4 years who inadvertently received Fluvirin on an unspecified date. On an unspecified date the vaccinees inadvertently received Fluvirin. No adverse symptoms were reported at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK					PJP200301074	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230515	12/09/2004					M	10/08/2004	A report was received from a health care professional on 13 November 2003 concerning a male vaccinee in his 40s who inadvertently received influenza vaccine (brand not specified) subcutaneously on 12 November 2003. On 12 November 2003, the vaccinee received influenza vaccine (brand unspecified) subcutaneously. At the time of the report no adverse event had occurred. There was insufficient information to determine the reporter's causality assessment. Update, 01 March 2004: Follow up information received from a health care professional indicated that there is no additional information forthcoming from the vaccinee. No follow up pending.									U	11/12/2003	11/12/2003	0		UNK	UNK					PJP200301075	1						1	Medication error	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0230516	12/09/2004		85.0	84		F	10/08/2004	A report was received from a health care professional on 11/13/03 concerning a 84 year old female vaccinee who inadvertently received 2 doses of Fluvirin, one on 11/13/03 and the other on an unspecified date. On 11/13/03, the vaccinee received Fluvirin, on another unspecified date another nurse administered Fluvirin to the vaccinee. The vaccinee had not experienced any adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/13/2003				UNK	UNK	NONE		NONE		PJP200301076	1						1	Medication error	FLU3~EVANS VACCINES~765707~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230517	12/09/2004		28.0			F	10/08/2004	A report was received from a health care professional on 11/13/03 concerning a 28 year old female vaccinee who experienced tingling in her upper and lower extremities 2 days after receiving Fluvirin on 11/8/03. On 11/10/03 the vaccinee experienced tingling in her upper and lower extremities. The symptoms went away and then returned. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 2/10/04: A follow up report was received from a health care professional indicating that the vaccinee experienced upper and lower extremity paraesthesia 2 days after receiving Fluvirin on 10/30/03. The vaccinee recovered after two days. No follow up, all information received.									Y	10/30/2003	11/01/2003	2		UNK	UNK	NONE		NONE		PJP200301078	1						1	Paraesthesia	FLU3~EVANS VACCINES~765957~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230518	12/09/2004					U	10/08/2004	A report was received from a health care professional on 10/3/03 concerning a vaccinee of unspecified demography who experienced a sore neck 2 to 3 days after receiving Fluvirin on an unknown date in 2003. On an unspecified date a vaccinee experienced a sore neck. It was not reported if the vaccinee had recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									Y	09/01/2003	09/01/2003	0		UNK	UNK	NONE		NONE		PJP200301080	1						1	Neck pain	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230519	12/09/2004					U	10/08/2004	A report was received from a health care professional on 10/3/03 concerning a vaccinee of unspecified demography who experienced pain in the arm, neck and ear, and a fever 2 to 3 days after receiving Fluvirin on an unknown date in 2003. On an unspecified date the vaccinee experienced pain in the arm, neck and ear, and felt feverish. It was not reported if the vaccinee had recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									Y	09/01/2003	09/01/2003	0		UNK	UNK	NONE		NONE		PJP200301081	1						1	Ear pain; Neck pain; Pain; Pyrexia	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230520	12/09/2004					F	10/08/2004	A report was received from a health care professional on 10/3/03 concerning a female vaccinee of unspecified age who experienced confusion and a tingling sensation 1 day after receiving Fluvirin on an unknown date in 2003. On an unspecified date the vaccinee experienced confusion and a tingling sensation all over her body. The confusion and tingling resolved within 24 hours. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									Y	09/01/2003	09/01/2003	0		UNK	UNK	NONE		NONE		PJP200301082	1						1	Confusional state; Paraesthesia	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230521	12/09/2004					F	10/08/2004	A report was received from a health care professional on 11/14/03 concerning a female vaccinee in her 40s who experienced muscle soreness around the injection site, limitation of motion, and muscle weakness within one week of receiving Fluvirin on 10/14/03. Within one week of receiving Fluvirin, the vaccinee experienced muscle soreness around the injection site, limitation of motion, and muscle weakness. The vaccinee had not recovered at the time of the report. The vaccinee had no previous medical history. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									N	10/14/2003	10/21/2003	7		UNK	UNK	NONE		NONE		PJP200301084	1						1	Injection site pain; Joint range of motion decreased; Muscular weakness; Myalgia	FLU3~EVANS VACCINES~765707~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230522	12/09/2004					U	10/08/2004	A report was received from a health care professional on 11/14/03 concerning 6 vaccinees of unknown demography who inadvertently received two 0.5ml doses of Fluvirin, one on 11/07/03 and another on 11/10/03. On 11/07/03 and on 11/10/03, 6 unidentified vaccinees inadvertently received a 0.5ml dose of Fluvirin. The vaccinees had not experienced any adverse reactions at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/07/2003	11/10/2003	3		UNK	UNK	NONE		NONE		PJP200301085	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230523	12/09/2004					U	10/08/2004	A report was received from a health care professional on 11/14/03 concerning a vaccinee of unspecified demography who inadvertently received Fluvirin via the SC route on an unspecified date. On an unspecified date, the vaccinee received Fluvirin via the SC route. The reporter did not know whether or not the vaccinee experienced any adverse symptoms after the event. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200301086	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230524	12/09/2004		56.0			F	10/08/2004	A report was received from a health care professional on 11/14/03, concerning a 56 year old female vaccinee who inadvertently received expired Fluvirin SC on 11/10/03. On 11/10/03, the vaccinee inadvertently received expired Fluvirin SC. The vaccinee had not experienced any adverse event at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/10/2003	11/10/2003	0		UNK	UNK	NONE		NONE		PJP200301087	1						1	Medication error	FLU3~EVANS VACCINES~E33142GA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230525	12/09/2004		1.2			U	10/08/2004	A report was received from a health care professional on 11/14/03 concerning a 14 month old vaccinee of unknown sex, who inadvertently received Fluvirin on an unknown date. On an unknown date a child under 4 years of age inadvertently received Fluvirin. At the time of the report no adverse events had occurred. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200301088	1						1	Medication error	FLU3~EVANS VACCINES~765138~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230526	12/09/2004		36.0			F	10/08/2004	A report was received from a health care professional on 10/24/03 concerning 4 vaccinees of unspecified demography who experienced redness and wheals at the injection site with itching on the same day as receiving Fluvirin on 10/24/03. On 10/24/03 the vaccinees experienced redness and wheals at the injection site with itching. The vaccinees recovered on 10/24/03. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 11/17/03: A follow up report was received indicating that a 36 year old female vaccinee experienced a large red wheal with redness, swelling and warmth within 20 minutes of receiving Fluvirin on 10/20/03. The vaccinee was treated with antihistamine. The vaccine recovered after 3-4 days.									Y	10/20/2003	10/20/2003	0		UNK	UNK	NONE		NONE		PJP200301090	1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Injection site warmth; Pruritus; Urticaria	FLU3~EVANS VACCINES~765874~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230527	12/09/2004		34.0			F	10/08/2004	A report was received from a health care professional on 10/24/03 concerning 4 vaccinees of unspecified demography who experienced redness and wheals at the injection site with itching on the same day as receiving Fluvirin on 10/24/03. On 10/24/03 the vaccinees experienced redness and wheals at the injection site with itching. The vaccinees recovered on 10/24/03. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 11/17/03: A follow up report was received indicating that a 34 year old female vaccinee experienced a local red wheal with redness, swelling, hives, and warmth within 20 minutes of receiving Fluvirin on 10/15/03. The vaccinee was treated with antihistamines. The vaccinee recovered after 3-5 days.									Y	10/15/2003	10/15/2003	0		UNK	UNK	NONE		NONE		PJP200301091	1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Injection site warmth; Pruritus; Urticaria	FLU3~EVANS VACCINES~765874~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230528	12/09/2004					U	10/08/2004	A report was received from a health care professional on 11/17/03 concerning multiple vaccinees less than 4 years of age who inadvertently received Fluvirin vaccine between early October 2003 to the time of the report. Between early October 2003 and the time of the report, multiple vaccinees under 4 years of age received Fluvirin. It was not reported if the vaccinees had experienced any adverse reactions. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/01/2003				UNK	UNK	NONE		NONE		PJP200301093	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230529	12/09/2004					F	10/08/2004	A report was received from a health care professional on 11/17/03 concerning a female vaccinee less than 4 years of age who inadvertently received 0.25ml Fluvirin vaccine on an unspecified day in November 2003. On an unspecified day in November 2003, the vaccinee received Fluvirin. It was not reported if the vaccinee had experienced any adverse reaction. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/01/2003	11/01/2003	0		UNK	UNK	NONE		NONE		PJP200301094	1						1	Medication error	FLU3~EVANS VACCINES~765873~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230530	12/09/2004					U	10/08/2004	A report was received on 11/17/03 from a health care professional concerning an unspecified number (approximately 20) of vaccinees who inadvertently received 1ml Fluvirin on 11/17/03. On 11/17/03, an unspecified number (approximately 20) of vaccinees inadvertently received 1ml Fluvirin. The vaccinees did not exhibit any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/17/2003	11/17/2003	0		UNK	UNK	NONE		NONE		PJP200301095	1						1	Medication error	FLU3~EVANS VACCINES~765955~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230531	12/09/2004		92.0			F	10/08/2004	A report was received from a consumer on 11/17/03 whom is a 92 year old female vaccinee who developed severe flu like symptoms after receiving influenza vaccine on an unknown date in 2002. On an unspecified date in 2002, the patient developed severe flu like symptoms consisting of fevers, decreased appetite, tiredness, and body aches. At the time of the report the consumer did not know when these symptoms began relative to administration of the influenza vaccine however the vaccinees symptoms lasted approximately 2 weeks. The vaccinee had a similar experience 14 years ago following administration of influenza vaccine. Follow up pending.									U	10/01/2002	10/01/2002	0		UNK	UNK	NONE		Flu like symptoms after receiving influenza vaccine.		PJP200301096	1						1	Decreased appetite; Fatigue; Influenza like illness; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0230532	12/09/2004					U	10/08/2004	A report was received from a health care professional on 11/17/03 concerning an unspecified number of vaccinees less than 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees under 4 years of age received Fluvirin. None of the vaccinees had experienced any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200301097	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230533	12/09/2004		4.0	3		M	10/08/2004	A report was received from a health care professional on 11/17/03 concerning a 3 year old male vaccinee who inadvertently received Fluvirin on 11/11/03. On 11/11/03, the vaccinee inadvertently received Fluvirin 0.5ml IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 4/27/04: A follow up report was received from a health care professional indicating that she left a message with the vaccinees parents requesting them to call if the vaccinee had experienced any adverse symptoms. The reporter did not receive a call back. No follow up pending; all information received.									U	11/11/2003	11/11/2003	0		UNK	UNK	NONE		NONE		PJP200301098	1						1	Medication error	FLU3~EVANS VACCINES~765874~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230534	12/09/2004		27.0			F	10/08/2004	A report was received form a health care professional on 11/17/03 concerning a 27 year old female vaccinee who experienced mild itchy rash 6 hours after receiving Fluvirin on 11/10/03. On 11/10/03, the vaccinee experienced a mild itchy rash that started on the arms and progressed to the chest and back. Diphenhydramine hydrochloride and loratadine were prescribed for symptomatic relief. The vaccinee had not recovered at the time of the report. The vaccinee had no prior history of allergies and had received Influenza vaccine on an unspecified date in 2002. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/10/2003	11/10/2003	0		UNK	UNK	NONE		NONE		PJP200301099	1						1	Rash pruritic	FLU3~EVANS VACCINES~765502~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230535	12/09/2004					M	10/08/2004	A report was received from a health care professional on 11/17/03 concerning a male vaccinee of unknown age who inadvertently received 1ml Fluvirin on 11/14/03. On 11/14/03, the vaccinee inadvertently received Fluvirin 1ml IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 4/12/04: Further information was received from a health care professional indicating that the vaccinee did not experience any adverse reaction. No follow up pending, no further information available.									U	11/14/2003	11/14/2003	0		UNK	UNK	NONE		NONE		PJP200301100	1						1	Medication error	FLU3~EVANS VACCINES~765704~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230536	12/09/2004					U	10/08/2004	A report was received from a health care professional on 11/17/03 concerning a group of approximately 18 vaccinees who inadvertently received Fluvirin SC between 11/4/03 and 11/5/03. Between 11/4/03 and 11/5/03, approximately 18 vaccinees were administered Fluvirin SC. All vaccinees were in good health at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/04/2003	11/04/2003	0		UNK	UNK	NONE		NONE		PJP200301101	1						1	Medication error	FLU3~EVANS VACCINES~765853~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230537	12/09/2004		49.0	48		F	10/08/2004	A report was received from a consumer on 11/17/03 concerning a 48 year old female vaccinee who inadvertently received expired Fluvirin on 11/17/03. On 11/17/03, the vaccinee inadvertently received expired Fluvirin. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/16/2003	11/16/2003	0		UNK	UNK	NONE		NONE		PJP200301102	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230538	12/09/2004					U	10/08/2004	A report was received from a health care professional on 11/17/03 concerning 2 vaccinees of unspecified demography who experienced vomiting and diarrhea an unspecified length of time after inadvertently receiving Fluvirin SC between 11/4/03 and 11//03. Between 11/4/03 and 11/5/03, 2 vaccinees experienced vomiting and diarrhea after receiving Fluvirin SC. The vaccinees missed work for 3 days after receiving the vaccine. The vaccinees recovered on an unspecified date. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									Y	11/04/2003	11/04/2003	0		UNK	UNK	NONE		NONE		PJP200301103	1						1	Diarrhoea; Medication error; Vomiting	FLU3~EVANS VACCINES~765853~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230539	12/09/2004		0.62	0	.6	M	10/08/2004	A report was received from a consumer on 11/18/03, concerning a 6.5 month old male vaccinee who inadvertently received Fluvirin on 11/14/03. On 11/14/03, the vaccinee inadvertently received Fluvirin. The vaccinee did not exhibit any adverse symptoms at the time of reporting. Follow up pending.									U	11/14/2003	11/14/2003	0		UNK	UNK	NONE		NONE		PJP200301107	1						1	Medication error	FLU3~EVANS VACCINES~765668~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230540	12/09/2004		4.0	3		M	10/08/2004	A report was received from a health care professional on 11/18/03, concerning a 3 year old male vaccinee who inadvertently received Fluvirin on 11/14/03. On 11/14/03, the vaccinee inadvertently received 0.5ml Fluvirin. The vaccinee did not exhibit any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1/13/04: A follow up report was received from a health care professional indicating that no adverse events had occurred at the time of reporting. Follow up pending.									U	11/14/2003	11/14/2003	0		UNK	UNK	NONE		NONE		PJP200301108	1						1	Medication error	FLU3~EVANS VACCINES~765667~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230541	12/09/2004		34.0	34		F	10/08/2004	A report was received from a health care professional on 11/18/03, concerning a female vaccinee in her 30s who experienced a cold sensation and numbness on the left side of her face neck and arm one hour after receiving Fluvirin on 11/18/03. On 11/18/03, the vaccinee received Fluvirin 0.5ml. One hour later the vaccinee complained of a cold sensation and numbness on the left side of her face, neck and arm. There was insufficient information to determine the reporter's causality assessment. Update 4/19/04: A follow up report was received from a health care professional indicating that the 34 year old female vaccinee experienced paraesthesia with cold sensation and numbness on the ipsilateral side of her face, neck, and arms. The vaccinee was referred to a primary care physician for examination and no neurological defect was noted. The vaccinee recovered on an unspecified date. The vaccinee had no previous exposure to Fluvirin. The reporter has assessed the relationship of the vaccinee to the events as probable. No follow up pending, all information received.									Y	11/18/2003	11/18/2003	0		UNK	UNK	NONE		NONE; Allergic Rhinitis		PJP200301111	1						1	Feeling cold; Hypoaesthesia; Paraesthesia	FLU3~EVANS VACCINES~765486~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230542	12/09/2004		3.0			F	10/08/2004	A report was received from a health care professional on 11/18/03, concerning a 3 year old vaccinee of unknown gender who inadvertently received Fluvirin on 11/11/03. On 11/11/03 the vaccinee received 0.25ml Fluvirin. The vaccinee did not exhibit any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1/19/04: A follow up report was received from a health care professional indicating that the 3 year old female vaccinee received Fluvirin on 11/10/03 approximately. No follow up pending, all information received.									Y	11/10/2003				UNK	UNK	UNK		UNK		PJP200301112	1						1	Medication error	FLU3~EVANS VACCINES~766055~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230543	12/09/2004		35.0			F	10/08/2004	A report was received from a health care professional on 11/10/03, concerning a 35 year old female vaccinee who developed erythema at the injection site on 10/10/03 after receiving Fluvirin vaccine on 10/09/03. On 10/10/03 the vaccinee developed erythema at the injection site after receiving Fluvirin on 10/9/03. The event resolved 2 days later. There was insufficient information to determine the reporter's causality assessment. No follow up pending.									U	10/09/2003	10/10/2003	1		UNK	UNK	UNK		UNK		PJP200301113	1						1	Injection site erythema	FLU3~EVANS VACCINES~765703~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230544	12/09/2004					M	10/08/2004	A report was received from a health care professional on 11/19/03 concerning a male vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporters causality assessment. Follow up pending.									U	11/06/2003	11/13/2003	7		UNK	UNK	UNK		UNK		PJP200301117	1						1	Cough; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea	FLU3~EVANS VACCINES~765855~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230545	12/09/2004					M	10/08/2004	A report was received from a health care professional on 11/19/03 concerning a male vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/06/2003	11/13/2003	7		UNK	UNK	UNK		UNK		PJP200301118	1						1	Cough; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea	FLU3~EVANS VACCINES~765855~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230546	12/09/2004					M	10/08/2004	A report was received from a health care professional on 11/19/03 concerning a male vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/06/2003	11/13/2003	7		UNK	UNK	NONE		NONE		PJP200301119	1						1	Cough; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea	FLU3~EVANS VACCINES~765855~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230547	12/09/2004					M	10/08/2004	A report was received from a health care professional on 11/19/03 concerning a male vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/06/2003	11/13/2003	7		UNK	UNK	UNK		UNK		PJP200301120	1						1	Cough; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea	FLU3~EVANS VACCINES~765855~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230548	12/09/2004					F	10/08/2004	A report was received from a health care professional on 11/19/03 concerning a female vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat within 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, within one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/06/2003	11/13/2003	7		UNK	UNK	NONE		NONE		PJP200301121	1						1	Cough; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea	FLU3~EVANS VACCINES~765855~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230549	12/09/2004					F	10/08/2004	A report was received from a health care professional on 11/19/03 concerning a female vaccinee more than 65 years old who experienced sinffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/06/2003	11/13/2003	7		UNK	UNK	NONE		NONE		PJP200301122	1						1	Cough; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea	FLU3~EVANS VACCINES~765855~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230550	12/09/2004		66.0			M	10/08/2004	A report was received from a health care professional on 11/19/03 concerning a male vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Follow up information received from a health care professional indicated that a 66 year old vaccinee received Fluvirin on 11/9/03. on 11/15/03, the patient also experienced a high temperature of 100 degrees, nasal drainage and had a productive cough. The patient recovered from these events on 11/20/03. Follow up pending.									N	11/09/2003	11/16/2003	7		UNK	UNK	NONE		NONE		PJP200301123	1						1	Cough; Nasal congestion; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea	FLU3~EVANS VACCINES~765855~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230551	12/09/2004					M	10/08/2004	A report was received from a health care professional on 11/19/03 concerning a male vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/06/2003	11/13/2003	7		UNK	UNK	NONE		NONE		PJP200301124	1						1	Cough; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea	FLU3~EVANS VACCINES~765855~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230552	12/09/2004		88.0			F	10/08/2004	A report was received from a health care professional on 11/19/03 concerning a female vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Follow up information received from a health care professional indicated that an 88 year old vaccinee received Fluvirin on 11/10/03. On 11/12/03 the patient also experienced a productive cough and lung congestion. These events in addition to the sore throat resolved on 11/19/03. Follow up pending.									U	11/10/2003	11/17/2003	7		UNK	UNK	NONE		NONE		PJP200301125	1						1	Cough; Nasal congestion; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea	FLU3~EVANS VACCINES~765855~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230553	12/09/2004		78.0			M	10/08/2004	A report was received from a health care professional on 11/19/03 concerning a male vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Follow up information received from a health care professional indicated that the 78 year old vaccinee received Fluvirin on 11/3/03 and also experienced on 11/12/03 a high temperature of 99 degrees, moist cough, emesis and shortness of breath. The vaccinee recovered from these events on 11/17/03. Follow up pending.									Y	11/03/2003	11/10/2003	7		UNK	UNK	NONE		NONE		PJP200301128	1						1	Cough; Dyspnoea; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea; Vomiting	FLU3~EVANS VACCINES~765855~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230554	12/09/2004					U	10/08/2004	A report received from a health care professional on 11/19/03, concerning an unspecified number of children aged less than 4 years of age of unknown sex who inadvertently received Fluvirin on an unspecified date. On an unspecified date, an unspecified number of children aged less than 4 years of age inadvertently received Fluvirin. The reporter did not know if any of the children had experienced adverse events at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200301130	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230555	12/09/2004		50.0			F	10/08/2004	A report was received from a health care professional on 11/19/03 concerning a 50 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to touch 1 day after receiving Fluvirin on 11/18/03. On 11/19/03, the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half a dollar in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporters causality assessment. Follow up pending.									N	11/18/2003	11/19/2003	1		UNK	UNK	NONE		NONE		PJP200301131	1						1	Injection site erythema; Injection site swelling; Injection site warmth; Urticaria	FLU3~EVANS VACCINES~765751~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230556	12/09/2004		32.0			F	10/08/2004	A report was received from a health care professional on 11/19/03 concerning a 32 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to touch 1 day after receiving Fluvirin on 11/18/03. On 11/19/03, the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half a dollar in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									N	11/18/2003	11/19/2003	1		UNK	UNK	NONE		NONE		PJP200301132	1						1	Injection site erythema; Injection site swelling; Injection site warmth; Urticaria	FLU3~EVANS VACCINES~765751~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230557	12/09/2004		29.0			F	10/08/2004	A report was received from a health care professional on 11/19/03 concerning a 29 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to touch 1 day after receiving Fluvirin on 11/18/03. On 11/19/03 the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half a dollar in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									N	11/18/2003	11/19/2003	1		UNK	UNK	NONE		NONE		PJP200301133	1						1	Erythema; Injection site swelling; Injection site warmth; Urticaria	FLU3~EVANS VACCINES~765751~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230558	12/09/2004		50.0			F	10/08/2004	A report was received from a health care professional on 11/19/03 concerning a 50 year old female vaccinee who experienced a localized red wheal at the injection site which was raised, itchy and warm to touch 1 day after receiving Fluvirin on 11/18/03. On 11/19/03 the vaccinee experienced a localized red wheal at the injection site, 4x4 inches in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									N	11/18/2003	11/19/2003	1		UNK	UNK	NONE		NONE		PJP200301134	1						1	Injection site hypersensitivity; Injection site swelling; Injection site warmth; Pruritus; Urticaria	FLU3~EVANS VACCINES~765751~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230562	12/09/2004	NJ	0.85	0	.8	M	12/06/2004	Approximately 3 AM on morning following vaccine administration, pt experienced generalized tonic-clonic seizure of duration approximately 45 minutes. Transported to ED via EMS. Received Ativan x 2 dose and phenobarbital and admitted to pediatric ICU. Fever noted on presentation to ED. Discharge Summary received 1/06/2005 states inflammed tympanic membrane and rhonci.			Y	Y	Y	3			Y	11/29/2004	11/30/2004	1	MRI normal. Blood, CSF cultures negative (no growth).	PVT	PVT	NONE	NONE	NONE			1						1	Convulsion; Lung disorder; Otitis media; Pyrexia	FLU3~SANOFI PASTEUR~U1512AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0230563	12/09/2004	CA	13.0	13		M	11/19/2004	After Flu and Hep A vaccines, pt complained of chest pain, had emesis. ST - T changed on EKG and elevated troponin level suggestive of transient ischemia, required admission. Discharge Summary received on 1/13/2005 states lab test abnormal.					Y	1			Y	11/10/2004	11/10/2004	0	ST changes on EKG, elevated troponin level CRP idhs.	PUB	OTH	Asachol, 6 MP, folic acid	Crohn's Disease; Strep	Pharyngitis			1						1	Chest pain; Electrocardiogram abnormal; Laboratory test abnormal; Transient ischaemic attack; Vomiting	FLU3~SANOFI PASTEUR~U1456AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~816A2~1~IM~~HEP A (HAVRIX)~1	USA	Hospitalisation	Influenza
0230564	12/09/2004	MA	49.0	48		F	12/02/2004	Severe swelling airway, SOB. Began about 24 hours after vaccine administered. To ED; treated with IV Solumedrol, IV Benadryl, PO Prednisone, PO Benadryl. Recovered completely. Follow Up: Diagnosis in ER was anaphylaxis. Patient was seen in ER 48 hourss/p vaccine receipt. Pt has history of mild egg allergy, but has received flu vaccine x 3 without AE.			Y	Y					Y	11/10/2004	11/11/2004	1	Chest x-ray normal; EKG normal.	PUB	PUB	Theophylline; Claritin; Albuterol	DM; Hypertension; Asthma	Allergic: Penicillin; ASA			1						1	Dyspnoea; Throat tightness	FLU3~SANOFI PASTEUR~U1499AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0230565	12/09/2004	TN	9.0	8		M	12/08/2004	About 6 hrs pt broke out rash, itching, advised, per Dr. take Benadryl as directed.									Y	12/02/2004	12/02/2004	0		PVT	PVT	NONE	NONE	NONE			1						1	Pruritus; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500352P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0230566	12/09/2004	UT	24.0	24		F	11/22/2004	Short of breath treated in ER swollen tongue 5 days of steroids antihistimines				Y					Y	11/18/2004	11/18/2004	0		PVT	UNK		NONE	Amoxicillin, Bactrim, Keflex			1						1	Dyspnoea; Tongue oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0230567	12/09/2004	IL	32.0	31		F	12/03/2004	Symptoms started with a cough that after 4 hours became a restrictive cough c/o headache and fatigue. Difficulty going to sleep that night due to cough and tightness of airway used Albuterol inhaler a total of 3 times, symptoms resolving 24 hours later. Albuterol is pt's own medication.									Y	12/02/2004	12/02/2004	0	NONE	PUB	PVT	Depakote ER, Paxil CR, Amitripoline, Tizandine, Flonase Nasal Spray	No acute illness	Epilepsy, Fibrompalsia, Irritable bowel syndrome, latent egg allergy			1						1	Cough; Fatigue; Headache; Insomnia; Throat tightness	FLU3~SANOFI PASTEUR~U1518AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230568	12/09/2004	TN	29.0	29		F	11/15/2004	After receiving flu vaccine, 10 min later, c/o splotchy, reddened area with soreness at site. Also c/o tingling around mouth 10 min later hives developing lower R arm. Diphenhydramine 25mg/.5cc IM given.									Y	11/15/2004	11/15/2004	0		PUB	UNK	OCs Yasmin 28				TN04065	1						1	Injection site erythema; Injection site pain; Paraesthesia; Rash maculo-papular; Urticaria	FLU3~SANOFI PASTEUR~U1518AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230569	12/09/2004	WA	12.0	12		M	11/22/2004	8x5cm oval red warm area, not tender, slightly indurated				Y					Y	11/16/2004	11/17/2004	1		PVT	PVT		NONE			WA042080	1						1	Feeling hot; Injection site erythema; Injection site mass	FLU3~SANOFI PASTEUR~U1515AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0230570	12/09/2004	AR	70.0	70		F	12/06/2004	About 2 1/2 hours after the flu shot, I felt severe pain in my left shoulder (right shoulder too but left). My left arm was painful and useless for the next 7 days. My doctor said the needle may have scraped my muscle because there was black and blue mark 1 inch wide. The vaccine maybe fighting off something.									Y	11/03/2004	11/03/2004	0		PUB	PUB		NONE				1						1	Contusion; Injection site pain; Myasthenic syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0230571	12/09/2004	MA	79.0	79		F	12/06/2004	Had flu shot at 10:30AM on Oct 30th 2004 at the above location. Left to go shopping at mall. At 3:00PM notice urgent need to pass urine and when I did there was burning and spasms when urination ended. I'm not a frequent UTI pt and have only had UTI 3-4 in my lifetime. Drug 412105 smz tmp 800 160 20TAB. Recovered after taking antibiotic for 10 days.									Y	10/30/2004	10/30/2004	0	Hospital: urine test and culture ordered by MD.	PVT	UNK	Aspirin 325mg tid, Synthroid 50mcg daily, Betoptic 0.25% bid, Lotemax 2 BID, Predfort R BID	NONE	NONE			1						1	Dysuria; Micturition urgency; Muscle spasms	FLU3~SANOFI PASTEUR~U1519AB~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230572	12/09/2004	NY	57.0	57		F	12/06/2004	3.0 x 3.5 cm area of erythema very hard and tender to touch.									Y	11/30/2004	12/01/2004	1		PUB	PVT	Coral calcium, ASA 81mg everyday, Toprol XL 100 bid, Meclizine 25 everyday	NONE	NONE			1						1	Injection site erythema; Injection site mass; Tenderness	FLU3~SANOFI PASTEUR~U1439AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230573	12/09/2004	FL	44.0			M	11/23/2004	This is a non-serious case from a medical assistant in the USA who reports a patient experienced cough after receiving FluMist. The reporter did not assess causality between events and FluMist vaccination. This case is being submitted according to the safety surveillance accelerated reporting agreement for FluMist. Within 24 hours of receiving FluMist on 11/5/04, a 44 year old male experienced cough, headache, runny nose, fatigue, fever, and chills. The patient was treated with OTC products and has recovered.									Y	11/05/2004	11/06/2004	1		PVT	PVT	NONE		NONE		MEDI0002479	1						1	Chills; Cough; Fatigue; Headache; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500336P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0230574	12/09/2004	OR	14.0			F	11/29/2004	This is not a serious case from a nurse in the USA of involving accidental exposure. The reporter causality is not reported to FluMist. The case qualifies for accelerated reporting. This case is a case of possible accidental expoure to the FluMist vaccine. A parent called to report that she had developed sore throat, cough, weakness, and fatigue with onset beginning the same day of administration (see MEDI0002477). While reporting her own adverse event she also stated that her 14 year old daughter also experienced sore throat, cough, weakness, and fatigue beginning four days after the mother was vaccinated on 11/10/04. The child did not receive the vaccine, and was fully recovered on 11/20/04.									Y		11/14/2004			OTH	OTH	Concomitant drugs not used.				MEDI0002481	1						1	Asthenia; Cough; Fatigue; Medication error; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0230585	12/09/2004	MI	66.0	65		M	12/09/2004	PAINFULL TO THE TOUCH SWELLING ON RIGHT ARM ABOVE ELBOW.  RED RASH.									N	12/07/2004	12/07/2004	0		UNK	UNK		DIABETIC INSULIN DEPENDANT	NONE			1						1	Erythema; Pain; Rash; Swelling	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|PPV~MERCK & CO. INC.~~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0230587	12/09/2004	WV	33.0	33		F	12/09/2004	The R.N. received a flu vaccine prior to going home after night tern.  After she woke up, late afternoon, she noticed a generalized rash and itching hives.  She took a Benadryl capsule.  No fever was noted or any other symptoms.  Within a few hours, the symptoms were resolved. Symptoms resolved within 24 hrs. Rash and hives were initially noted to left arm then  later to front of the legs and stomach very sparsely.									Y	12/06/2004	12/06/2004	0	None	UNK	UNK	Pt/staff had began taking Amoxicillin 3 days prior to flu vaccine.	None	None			1						1	Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U152AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230588	12/09/2004	NJ	69.0	69		F	12/09/2004	Received flu vaccine 11/15/04 and since then has had achiness in hands, elbows and legs accompanied by a warmness in hands. Physician has given her an antibiotic.				Y					U	11/15/2004	11/19/2004	4		UNK	UNK	Dioban and Femara	No	Hx of breast cancer > 8 years			1						1	Feeling hot; Pain	FLU3~SANOFI PASTEUR~U1579AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0230589	12/09/2004	MI	42.0	41		F	12/09/2004	Fever with myalgias 10/18/04 HA ,10/19/04 stiff neck, 10/25/04 rash pruritic, 10/28/04 worsening of rash, myalgias continue, 11/1/04 rash persists, neck pain, 11/8/04 getting better, 11/23/04 adverse symptoms resolved, 12/7/04 tingling of hands, stiff in back/shoulders. Follow up 12/9/04: Treatments have included Tylenol #3 PRN for headache and body ache relief. Benadryl PRN for relief of rash, Ibuprofen PRN for shoulder and neck pain. Medrol Dose pack. 10/28/04 Prednisone 60 mg x5 days, 50mg for 3 days, 40mg for 3 days, 30 mg fpr 3 days, 20 mg for 3 days, 10 mg for 3 days on 11/01/04. Symptoms resolved with use of above measures but for short periods and them to return. Follow up 12/21/04: Update on possible adverse reaction to flu vaccine; 1. Patient had a + lyme titer on 12/10/04, 2. confirmation of + lyme titer by western blot on 12/15/04, 3. patient now being trated with Doxycyline 100mg  for 1 month, 4. Patient to see rheumatologist for evaluation of symptoms on 01/03/05.				Y					N	10/12/2004	10/12/2004	0	AST, alk phos, CPK, UA, monospot, CBC, CMP, Strep screen, lyme antibody, Liver panel, ESR. Follow up 12/09/04: Labs on 10/18/04 reveal elevated SGOT, elevated alkaline phosphatase, Negative Monospot, elevated ESR, elevated SGPT, elevated neutrophil count, low lymphocyte count, negative strep screen. Labs on 10/28/04 negative lyme antibody, elevated alkaline phosphatase, elevated ESR, High platelet count, elevated neutrophil count, low lymphocyte count, low monocytes. Labs on 11/01/04 elevated platelet count, elevated neutrophil count, low lymphocyte, low monocyte, elevated ESR, elevated glucose, elevated SGPT,  albumin low, A/G ratio low.	PVT	PVT	Flovent 110mcg 2 puffs bid, Albuterol MDI 2 puffs q prn	Healthy at time vaccine was given	Hx of asthma			1						1	Headache; Laboratory test abnormal; Musculoskeletal stiffness; Myalgia; Neck pain; Paraesthesia; Pyrexia; Rash pruritic	FLU3~SANOFI PASTEUR~U1421AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0230590	12/09/2004	FL	10.0	10		M	12/09/2004	45 min post vaccine: hives x3 on neck interior, 1 1/2 hours post vaccine: resolution of above after elimination of Diphenhydramine 12.5/5ml 10ml PO 15 min after onset of sxs.									Y	12/09/2004	12/09/2004	0		OTH	PUB		Asthma	Moderate persistent asthma, allergic reaction			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1452AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230600	12/10/2004		46.0			F	10/08/2004	A report was received from a health care professional on 11/19/03 concerning a 46 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to touch one day after receiving Fluvirin on 11/18/03. On 11/19/03 the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half a dollar in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/18/2003	11/19/2003	1		UNK	UNK	NONE		NONE		PJP200301135	1						1	Injection site erythema; Injection site swelling; Injection site warmth; Urticaria	FLU3~EVANS VACCINES~765751~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230601	12/10/2004		27.0			F	10/08/2004	A report was received from a health care professional on 11/19/03 concerning a 27 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to touch one day after receiving Fluvirin on 11/18/03. On 11/19/03 the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half a dollar in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up  pending.									N	11/18/2003	11/19/2003	1		UNK	UNK	NONE		NONE		PJP200301136	1						1	Injection site erythema; Injection site swelling; Injection site warmth; Urticaria	FLU3~EVANS VACCINES~765751~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230602	12/10/2004		51.0			F	10/08/2004	A report was received from a health care professional on 11/19/03 concerning a 51 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to touch 1 day after receiving Fluvirin on 11/18/03. On 11/19/03 the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half a dollar in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									N	11/18/2003	11/19/2003	1		UNK	UNK	NONE		NONE		PJP200301137	1						1	Injection site erythema; Injection site swelling; Injection site warmth; Urticaria	FLU3~EVANS VACCINES~765751~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230603	12/10/2004		52.0			F	10/08/2004	A report was received from a healthcare professional on 11/19/03 concerning a 53 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to the touch one day after receiving Fluvirin on 11/18/03. On 11/19/03 the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half a dollar in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									N	11/18/2003	11/19/2003	1		UNK	UNK	NONE		NONE		PJP200301138	1						1	Injection site erythema; Injection site swelling; Injection site warmth; Urticaria	FLU3~EVANS VACCINES~765751~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230604	12/10/2004		37.0			F	10/08/2004	A report was received from a health care professional on 11/19/03 concerning a 37 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to touch 1 day after receiving Fluvirin on 11/18/03. On 11/19/03, the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half dollar in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									N	11/18/2003	11/19/2003	1		UNK	UNK	NONE		NONE		PJP200301139	1						1	Injection site erythema; Injection site swelling; Injection site warmth; Urticaria	FLU3~EVANS VACCINES~765751~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230605	12/10/2004		47.0			F	10/08/2004	A report was received from a health care professional on 11/19/03 concerning a 47 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to touch 1 day after receiving Fluvirin on 11/18/03. On 11/19/03 the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half dollar in size, raised and warm to the touch. The vaccine had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									N	11/18/2003	11/19/2003	1		UNK	UNK	NONE		NONE		PJP200301140	1						1	Injection site erythema; Injection site swelling; Injection site warmth; Urticaria	FLU3~EVANS VACCINES~765751~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230606	12/10/2004					U	10/08/2004	A report was received from a health care professional on 11/19/03 concerning approximately 60 children ranging from 6 months to 3 years of age of unknown sex who inadvertently received Fluvirin between October 2003 and November 2003. Approximately 60 children under 4 years of age inadvertently received Fluvirin between October 2003 and November 2003. At the time of the report no adverse events had occurred. There was insufficient information to determine the reporters causality assessment. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200301141	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230607	12/10/2004		0.5			F	10/08/2004	A report was received from a health care professional on 11/19/03 concerning a 6 month old female vaccinee who inadvertently received Fluvirin sometime during the week of 11/10/03. On an unspecified date in November 2003, a 6 month old female vaccinee inadvertently received Fluvirin. At the time of the report, no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/10/2003				UNK	UNK	NONE		NONE		PJP200301142	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230608	12/10/2004		56.0	56		M	10/08/2004	A report was received from a health care professional on 11/19/03 concerning a male vaccine of unknown age who experienced total body aches, malaise, and fever after receiving Fluvirin on an unknown date. On an unknown date, the vaccinee experienced total body aches, malaise, fever, and was bedridden for 4 days after receiving Fluvirin. This was the first time the vaccinee had been exposed to the influenza vaccine. It was not reported if the vaccinee had recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 12/23/03: An update report indicated that the vaccinee was a 56 year old male who experienced severe muscle, ligament and bone pain, a temperature of 102 degrees, extreme pain in the eyes with headache which lasted for 5 days and muscle pain, fatigue, and weakness which lasted for 4 days after receiving Fluvirin on 10/10/03. No follow up pending.									Y	10/10/2003				UNK	UNK	NONE		NONE		PJP200301143	1						1	Asthenia; Bone pain; Eye pain; Fatigue; Headache; Malaise; Myalgia; Pain; Pyrexia	FLU3~EVANS VACCINES~765409~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230609	12/10/2004					M	10/08/2004	A report was received from a health care professional on 11/19/03 concerning an approximately 50 year old male vaccinee who inadvertently received two doses of Fluvirin on 11/19/03. On 11/19/03 a vaccinee inadvertently received two doses of Fluvirin. The vaccinee he had not experienced any adverse events related to this incident at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/19/2003	11/19/2003	0		UNK	UNK	NONE		NONE		PJP200301144	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230610	12/10/2004		1.21	1	.2	F	10/08/2004	A report was received from a health care professional on 11/20/03 concerning a female vaccinee aged between 15 and 18 months who inadvertently received Fluvirin on 10/31/03. On 10/31/03 a vaccinee under 4 years of age inadvertently received Fluvirin. No adverse symptoms were experienced at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1/13/04: A follow up report was received from a health care profession indicating that the vaccinee was 14 months old at the time of vaccination. No adverse events had occurred at the time of reporting. No follow up pending, all information received.									U	10/31/2003	10/31/2003	0		UNK	UNK	NONE		NONE		PJP200301145	1						1	Medication error	FLU3~EVANS VACCINES~765854~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230611	12/10/2004		2.0	2	.1	F	10/08/2004	A report was received from a health care professional on 11/20/03 concerning a female vaccinee aged 2 years who inadvertently received Fluvirin on 11/5/03. On 11/5 a vaccinee under 4 years of age inadvertently received Fluvirin. No adverse symptoms were experienced at the time of the report. There was insufficient information to determine the reporter's causality assessment. A follow up report was received from a health care professional indicating that no adverse events had occurred at the time of reporting. No follow up pending, all information.									U	11/05/2003	11/05/2003	0		UNK	UNK	NONE		NONE		PJP200301146	1						1	Medication error	FLU3~EVANS VACCINES~765854~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230612	12/10/2004		13.0			M	10/08/2004	A report was received from a health care professional on 11/20/03 concerning a male vaccinee in his 20's who experienced a red, swollen and warm to touch injection site immediately after inadvertently receiving Fluvirin via a needleless injector on 11/13/03. On 11/13/03 the vaccinee experienced a red, swollen and warm to touch injection site after inadvertently receiving Fluvirin via a needleless injector. The outcome of the events was unknown at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/13/2003	11/13/2003	0		UNK	UNK	NONE		NONE		PJP200301147	1						1	Injection site erythema; Injection site swelling; Injection site warmth; Medication error	FLU3~EVANS VACCINES~765753~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230613	12/10/2004					M	10/08/2004	A report was received from a health care professional on 11/20/03 concerning a male vaccinee in his 50's who experienced a redness at the site of injection 2 days after inadvertently receiving Fluvirin via a needleless injector on 10/20/03. On 10/22/03 the vaccinee experienced redness at the site of injection after inadvertently receiving Fluvirin via a needleless injector. The redness lasted a few days and had resolved at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									Y	10/20/2003	10/22/2003	2		UNK	UNK	NONE		NONE		PJP200301148	1						1	Injection site erythema; Medication error	FLU3~EVANS VACCINES~765753~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230614	12/10/2004					F	10/08/2004	A report was received from a health care professional on 11/20/03 concerning a female vaccinee in her 50's who experienced a redness at the site of injection 2 days after inadvertently receiving Fluvirin via a needleless injector on 10/20/03. On 10/22/03 the vaccinee experienced redness at the site of injection after inadvertently receiving Fluvirin via a needleless injector. The redness lasted a few days and had resolved at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									Y	10/20/2003	10/22/2003	2		UNK	UNK	NONE		NONE		PJP200301149	1						1	Injection site erythema; Medication error	FLU3~EVANS VACCINES~765753~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230615	12/10/2004		48.0	48		F	10/08/2004	A report was received from a health care professional on 11/21/03 concerning a 48 year old female vaccinee who experienced labyrinthitis after she received Fluvirin on 11/17/03. On 11/17/03 the vaccinee received Fluvirin. One hour after vaccination the vaccinee felt limp and weak in her extremities and head but not dizzy. The vaccinee could not walk and went to the emergency room and was diagnosed with labyrinthitis. On 11/18/03 the vaccinee experienced the same symptoms again. On 11/19/03 the vaccinee did not have any symptoms when her physician advised her not to take her other medications. On 11/20/03 the vaccinee experienced 2 episodes of the same symptoms and also had difficulty in holding up her head. On 11/21/03 the vaccinee experienced 1 episode of the same symptoms with less difficulty in holding up her head. On 11/25/03 the vaccinee 's condition had greatly improved. There was insufficient information to determine the reporter's causality assessment. Update 2/2/04: A follow up report was received from a health care professional indicating that the vaccinees symptoms had resolved 8 days after onset, when the schedule of the vaccinees medications was changed. The medications are Valproic Acid, Venlafaxine HCl and Amitriptyline. No follow up pending, all information received.									U	11/17/2003	11/17/2003	0		UNK	UNK	Depakote; Effexor; Amitriptyline		NONE		PJP200301150	1						1	Asthenia; Difficulty in walking; Hypotonia; Labyrinthitis	FLU3~EVANS VACCINES~765877~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230616	12/10/2004		53.0	53		F	10/08/2004	A report was received from a health care professional on 11/21/03 concerning a 53 year old female vaccinee who inadvertently received a sub-optimal dose of Fluvirin intradermally on 11/21/03. On 11/21/03 the vaccinee inadvertently received 0.1ml Fluvirin intradermally instead of PPD vaccination. At the time of reporting the vaccinee did not exhibit any adverse events. There was insufficient information to determine the reporter's causality assessment. Update 3/8/04: Further information was received from a health care professional indicating that the vaccinee experienced a local reaction which resolved in 3 days without any lasting effects. The reporter has assessed the relationship of the vaccine to the event as probable. No follow up pending, all information received.									U	11/21/2003	11/21/2003	0		UNK	UNK	NONE		NONE		PJP200301154	1						1	Medication error	FLU3~EVANS VACCINES~765502~UNK~ID~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230617	12/10/2004		0.77	0	.8	M	10/08/2004	A report was received from a health care professional on 11/20/03 concerning an 8 month old male vaccinee who inadvertently received Fluvirin on 11/20/03. On 11/20/03, the vaccinee inadvertently received Fluvirin. The vaccinee had previously received a dose of Fluzone. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1/19/04: A follow up report was received from a health care professional indicating that a second dose of Fluvirin was administered on 11/20/04. The vaccinee then returned in one week for 0.25ml of Fluzone. No further medical follow up was ordered by the physician. No adverse experiences were reported that the time of reporting. Update 2/24/04: A follow up report was received from a health care professional indicating that the vaccinee received Fluzone initially, followed by Fluvirin and finally a second dose of Fluzone was given 1 week after the inadvertent administration of Fluvirin. No adverse event had occurred at the time of reporting. No follow up pending, all information received.									U	11/20/2003	11/20/2003	0		UNK	UNK	NONE		NONE		PJP200301155	1						1	Medication error	FLU3~EVANS VACCINES~766054~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230618	12/10/2004		1.79	1	.8	M	10/08/2004	A report was received from a health care professional on 11/20/03 concerning an unspecified number of vaccinees under the age of 4 years who inadvertently received Fluvirin on unspecified dates. On unspecified dates the vaccinees inadvertently received Fluvirin IM. At the time of reporting the reporter had not been informed of any subsequent adverse events. There was insufficient information to determine the reporter's causality assessment. Update 3/15/04: Further information was received from a health care professional indicating that the vaccinee was a 21 month old male who inadvertently received Fluvirin on 11/19/03. No adverse events were reported at the time of the report. Follow up pending.									U	11/19/2003	11/19/2003	0		UNK	UNK	UNK		UNK		PJP200301156	1						1	Medication error	FLU3~EVANS VACCINES~765952~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230619	12/10/2004					F	10/08/2004	A report was received from a health care professional on 11/20/03 concerning an elderly female vaccinee who received Fluvirin on 11/10/03 and inadvertently received a further dose of Fluvirin on 11/20/03. On 11/10/03 the vaccinee received 0.5ml Fluvirin IM. On 11/20/03 the vaccinee received another dose of 0.5ml Fluvirin IM. At the time of reporting the reporter was not aware of any subsequent adverse events. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/20/2003	11/20/2003	0		UNK	UNK	NONE		NONE		PJP200301157	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230620	12/10/2004					M	10/08/2004	A report was received from a health care professional on 11/20/03 concerning a male vaccinee of unspecified age who inadvertently received ID Fluvirin on an unspecified date. On an unspecified date the vaccinee inadvertently received ID Fluvirin instead of tuberculin purified protein derivative. At the time of reporting the vaccinee did not exhibit any adverse events. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/19/2003	11/19/2003	0		UNK	UNK	NONE		NONE		PJP200301158	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~ID~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230621	12/10/2004					F	10/08/2004	A report was received from a consumer through their insurance company on 11/20/03 who is a female vaccinee of unspecified age who blacked out while driving her automobile, seven minutes after receiving Fluvirin on 10/20/03. On 10/20/03 the vaccinee blacked out while driving her automobile as a result of the vaccinee hit a fire hydrant. At the time of the report the outcome was not reported. Update 2/9/04: A follow up report was received from a health care professional indicating that the vaccinee was treated and released by an emergency department. The reporter did not see the vaccinee before, during or immediately after the incident. Follow up pending.									U	10/10/2003	10/10/2003	0		UNK	UNK	NONE		NONE		PJP200301159	1						1	Loss of consciousness	FLU3~EVANS VACCINES~765416~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230622	12/10/2004		10.0	9		F	10/08/2004	A report was received from a consumer on 11/21/03 concerning a 9 year old female vaccinee who experienced hives the night after receiving Fluvirin on 11/20/03. On 11/20/03 the vaccinee received Fluvirin and that night developed red bumps or hives that resembled bug bites. Hydrocortisone was applied to the affected area. On 11/21/03 the vaccinee developed more hives which were larger in size. The hives were treated with diphenhydramine hydrochloride. The vaccinee previously received a dose of the influenza vaccine for the past two years without any problems and has no history of hypersensitivity. The reporter did not know the outcome of the hives at the time of the report. Update 2/16/04: Follow up information received from a health care professional indicated that the vaccinee developed abdominal hives on 11/21/03 following administration of Fluvirin. The event resolved on an unspecified date. Follow up pending.									U	11/20/2003	11/21/2003	1		UNK	UNK	Tussionex		NONE		PJP200301163	1						1	Urticaria	FLU3~EVANS VACCINES~765707~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230623	12/10/2004		1.34	1	.3	M	10/08/2004	A report was received from a health care professional on 11/24/03 concerning a 16 month old vaccinee (gender unspecified) who inadvertently received Fluvirin on 11/24/03. On 11/24/03, the vaccinee inadvertently received 0.25ml Fluvirin. The dose was to be a booster dose to the initial dose that was previously administered. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1/9/04: A follow up report was received from a health care professional indicating that a 16 month old male vaccinee inadvertently received Fluvirin on 11/24/03. No adverse symptoms were reported at the time of reporting. No follow up pending.									U	11/24/2003	11/24/2003	0		UNK	UNK	NONE		NONE		PJP200301164	1						1	Medication error	FLU3~EVANS VACCINES~765502~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230624	12/10/2004					F	10/08/2004	A report was received from a health care professional on 11/24/03 concerning a female vaccinee of unknown age who was inadvertently administered frozen Fluvirin vaccine on 11/24/03. On 11/24/03, the vaccinee inadvertently received Fluvirin, which had been left adjacent to a freezer compartment and was subsequently frozen. The vaccinee will be advised to receive Fluvirin again in 3 weeks time. It was not reported if the vaccinee had experienced any adverse reaction. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/24/2003	11/24/2003	0		UNK	UNK	NONE		NONE		PJP200301165	1						1	Medication error	FLU3~EVANS VACCINES~765858~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230625	12/10/2004		1.85	1	.9	M	10/08/2004	A report was received from a health care professional on 11/24/03 concerning a 22 month old male vaccinee who inadvertently received Fluvirin on 11/24/03. On 11/24/03, the vaccinee inadvertently received 0.25ml Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 4/26/04: Further information was received from a health care professional indicating that the vaccinee experienced no obvious adverse events at the time of injection. The vaccinees mother was immediately notified and asked to call if the vaccinee developed any adverse events. The vaccinees mother has not called back to date. No follow up pending, all information received.									U	11/24/2003	11/24/2003	0		UNK	UNK	NONE		NONE		PJP200301166	1						1	Medication error	FLU3~EVANS VACCINES~765852~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230626	12/10/2004					U	10/08/2004	A report was received from a consumer on 11/24/03 concerning a vaccinee (gender unspecified) under 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date the vaccinee inadvertently received Fluvirin. No adverse symptoms were reported at the time of reporting. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200301167	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230627	12/10/2004		60.0			F	10/08/2004	A report was received from a health care professional on 11/24/03 concerning a 60 year old female vaccinee who inadvertently received expired Fluvirin on 11/10/03. On 11/10/03, the vaccinee inadvertently received expired Fluvirin. The vaccinee had not experienced any adverse effects as a result at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/8/04: Follow up information received from a health care professional indicated that the vaccinee did not experience any adverse reactions following vaccination with expired Fluvirin. No follow up pending, all information received.									U	11/10/2003	11/10/2003	0		UNK	UNK	NONE		NONE		PJP200301168	1						1	Medication error	FLU3~EVANS VACCINES~E34672HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230628	12/10/2004		3.0	2	.9	M	10/08/2004	A report was received from a consumer on 11/22/03 concerning a 2 year old male vaccinee who inadvertently received Fluvirin on 11/22/03. On 11/22/03 the vaccinee inadvertently received Fluvirin. No adverse symptoms were exhibited at the time of reporting. Follow up pending.									U	11/05/2003	11/05/2003	0		UNK	UNK	NONE		NONE		PJP200301169	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230629	12/10/2004		52.0			F	10/08/2004	A report was received from a health care professional on 11/24/03 concerning a 52 year old female vaccinee who inadvertently received expired Fluvirin vaccine on 11/10/03 approximately. On 11/10/03 approximately, the vaccinee inadvertently received expired Fluvirin. It was not reported if the vaccinee had experienced any adverse reaction. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/10/2003	11/10/2003	0		UNK	UNK	NONE		NONE		PJP200301170	1						1	Medication error	FLU3~EVANS VACCINES~E35762KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230630	12/10/2004		54.0			F	10/08/2004	A report was received from a health care professional on 11/24/03 concerning a 54 year old female vaccinee who inadvertently received expired Fluvirin vaccine on 11/10/03 approximately. On 11/10/03 approximately, the vaccinee inadvertently received expired Fluvirin. It was not reported if the vaccinee had experienced any adverse reaction. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/10/2003	11/10/2003	0		UNK	UNK	NONE		NONE		PJP200301171	1						1	Medication error	FLU3~EVANS VACCINES~E35762KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230631	12/10/2004		1.0			M	10/08/2004	A report was received from a health care professional on 11/10/03 concerning a 1 year old male vaccinee who inadvertently received Fluvirin on 10/20/03. On 10/20/03, the vaccinee received a single dose of Fluvirin 0.5ml. At the time of reporting the vaccinee did not exhibit any adverse effects. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/20/2003	10/20/2003	0		UNK	UNK	NONE		NONE		PJP200301172	1						1	Medication error	FLU3~EVANS VACCINES~765667~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230632	12/10/2004		2.0			F	10/08/2004	A report was received from a health care professional on 11/10/03 concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 10/20/03. On 10/20/03, the vaccinee received a single dose of Fluvirin 0.5ml. At the time of reporting, the vaccinee did not exhibit any adverse effects. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/20/2003	10/20/2003	0		UNK	UNK	NONE		NONE		PJP200301174	1						1	Medication error	FLU3~EVANS VACCINES~765667~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230633	12/10/2004		2.0			M	10/08/2004	A report was received from a health care professional on 11/10/03 concerning a 2 year old male vaccinee who inadvertently received Fluvirin on 10/27/03. On 10/27/03, the vaccinee received a single dose of Fluvirin 0.5ml. At the time of reporting the vaccinee did not exhibit any adverse effects. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/27/2003	10/27/2003	0		UNK	UNK	NONE		NONE		PJP200301175	1						1	Medication error	FLU3~EVANS VACCINES~765667~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230634	12/10/2004		0.6			F	10/08/2004	A report was received from a health care professional on 11/10/03 concerning a 7 month old female vaccinee who inadvertently received Fluvirin on 10/27/03. On 10/27/03, the vaccinee received a single dose of Fluvirin 0.25ml. At the time of reporting the vaccinee did not exhibit any adverse effects. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/27/2003	10/27/2003	0		UNK	UNK	NONE		NONE		PJP200301176	1						1	Medication error	FLU3~EVANS VACCINES~765667~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230635	12/10/2004		3.0			M	10/08/2004	A report was received from a health care professional on 11/10/03 concerning a 3 year old male vaccinee who inadvertently received Fluvirin on 10/27/03. On 10/27/03, the vaccinee received a single dose of Fluvirin 0.5ml. At the time of reporting, the vaccinee did not exhibit any adverse effects. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/27/2003	10/27/2003	0		UNK	UNK	NONE		NONE		PJP200301177	1						1	Medication error	FLU3~EVANS VACCINES~765667~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230636	12/10/2004		60.0			F	10/08/2004	A report was received from a health care professional on 11/25/03 concerning a 60 year old female vaccinee who received one dose of influenza vaccine (brand unspecified) on an unspecified date in October 2003 and then inadvertently received Fluvirin on 11/25/03. In October 2003, the vaccinee received a dose of influenza vaccine (brand unspecified) and on 11/25/03 the vaccinee received a dose of Fluvirin. At the time of the report, no adverse events have been reported. There was insufficient information to determine the reporter's causality assessment. No follow up pending.									U	11/25/2003				UNK	UNK	NONE		NONE		PJP200301178	1						1	Medication error	FLU3~EVANS VACCINES~765415~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230637	12/10/2004		2.0			F	10/08/2004	A report was received from a health care professional on 11/10/03 concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 10/27/03. On 10/27/03, the vaccinee received a single dose of Fluvirin 0.5ml. At the time of reporting, the vaccinee did not exhibit any adverse effects. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/27/2003	10/27/2003	0		UNK	UNK	NONE		NONE		PJP200301179	1						1	Medication error	FLU3~EVANS VACCINES~765667~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230638	12/10/2004		3.0			F	10/08/2004	A report was received from a health care professional on 11/10/03 concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 10/27/03. On 10/27/03, the vaccinee received a single dose of Fluvirin 0.5ml. At the time of reporting, the vaccinee did not exhibit any adverse effects. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/27/2003	10/27/2003	0		UNK	UNK	NONE		NONE		PJP200301180	1						1	Medication error	FLU3~EVANS VACCINES~765667~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230639	12/10/2004					U	10/08/2004	A report was received from a health care professional on 11/28/03 concerning approximately 40 vaccinees between the ages of 4-9 years and of unknown gender, who inadvertently received 0.24ml of Fluvirin between 10/6/03 and 11/21/03. Between 10/6/03 and 11/21/03, the vaccinees inadvertently received 0.25ml of Fluvirin. It was reported that no adverse events had occurred as a result, at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/06/2003				UNK	UNK	NONE		NONE		PJP200301181	1						1	Medication error	FLU3~EVANS VACCINES~769599~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230640	12/10/2004		2.0			F	10/08/2004	A report was received from a health care professional on 11/10/03 concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 10/29/03. On 10/29/03, the vaccinee received a single dose of Fluvirin 0.5ml. At the time of reporting the vaccinee did not exhibit any adverse effects. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/29/2003	10/29/2003	0		UNK	UNK	NONE		NONE		PJP200301182	1						1	Medication error	FLU3~EVANS VACCINES~765667~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230641	12/10/2004		0.53	0	.5	F	10/08/2004	A report was received from a health care professional on 11/25/03 concerning a 6 month old female vaccinee who inadvertently received Fluvirin on 11/04/03. On 11/4/03 the vaccinee inadvertently received 0.25ml of Fluvirin. At the time of the report, no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 3/11/04: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received.									U	11/04/2003	11/04/2003	0		UNK	UNK	NONE		NONE		PJP200301183	1						1	Medication error	FLU3~EVANS VACCINES~765952~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230642	12/10/2004		1.0			M	10/08/2004	A report was received from a healthcare professional on 11/10/03 concerning a 1 year old male vaccinee who inadvertently received Fluvirin on 11/4/03. On 11/4/03, the vaccinee received a single dose of Fluvirin 0.5ml. At the time of reporting, the vaccinee did not exhibit any adverse effects. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/04/2003	11/04/2003	0		UNK	UNK	NONE		NONE		PJP200301184	1						1	Medication error	FLU3~EVANS VACCINES~765667~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230643	12/10/2004		3.0			M	10/08/2004	A report was received from a health care professional on 11/10/03 concerning a 3 year old male vaccinee who inadvertently received Fluvirin on 11/4/03. On 11/4/03, the vaccinee received a single dose of Fluvirin 0.5ml. At the time of reporting, the vaccinee did not exhibit any adverse effects. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/04/2003	11/04/2003	0		UNK	UNK	NONE		NONE		PJP200301185	1						1	Medication error	FLU3~EVANS VACCINES~765667~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230644	12/10/2004		1.57	1	.6	M	10/08/2004	A report was received from a health care professional on 11/25/03 concerning a 20 month old male vaccinee who was inadvertently administered Fluvirin on 11/25/03. On 11/25/03, the vaccinee was inadvertently administered Fluvirin. The vaccinee had not experienced any adverse effects as a result at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/11/04: A follow up report was received from a health care professional who indicated that the vaccinee did not experience any adverse symptoms. The vaccinee had received his first shot of Fluzone on 10/21/03. No follow up pending, all information received.									U	11/25/2003	11/25/2003	0		UNK	UNK	NONE		NONE		PJP200301186	1						1	Medication error	FLU3~EVANS VACCINES~766050~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230645	12/10/2004		1.0			F	10/08/2004	A report was received from a health care professional on 11/10/03 concerning a 1 year old female vaccinee who inadvertently received Fluvirin on 11/4/03. On 11/4/03, the vaccinee received a single dose of Fluvirin 0.25ml. At the time of reporting the vaccinee did not exhibit any adverse effects. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/04/2003	11/04/2003	0		UNK	UNK	NONE		NONE		PJP200301187	1						1	Medication error	FLU3~EVANS VACCINES~765667~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230646	12/10/2004		1.0			M	10/08/2004	A report was received from a health care professional on 11/25/03 concerning a 1 year old male vaccinee who was inadvertently administered 0.5ml Fluvirin vaccine on 11/24/03. On 11/24/03 the vaccinee inadvertently received 0.5ml Fluvirin. At the time of the report the outcome was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Follow up letter returned unopened on 8/3/04. No new information provided.									U	11/24/2003	11/24/2003	0		UNK	UNK	NONE		NONE		PJP200301188	1						1	Medication error	FLU3~EVANS VACCINES~765952~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230647	12/10/2004		2.0			M	10/08/2004	A report was received from a health care professional on 11/25/03 concerning a 2 year old male vaccinee who was inadvertently administered 0.5ml Fluvirin vaccine on 11/24/03. On 11/24/03 the vaccinee inadvertently received 0.5ml Fluvirin. At the time of the report the outcome was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Follow up letter returned unopened on 8/3/04. No new information provided.									U	11/24/2003	11/24/2003	0		UNK	UNK	NONE		NONE		PJP200301189	1						1	Medication error	FLU3~EVANS VACCINES~765952~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230648	12/10/2004		63.0			F	10/08/2004	A report was received from a health care professional on 11/24/03 concerning a 63 year old female vaccinee who was inadvertently administered frozen Fluvirin vaccine on an unreported date. On unknown date, the vaccinee inadvertently received Fluvirin, which had been left adjacent to a freezer compartment and was subsequently frozen. The vaccinee will be advised to receive Fluvirin again in 3 weeks time. It was not reported if the vaccinee had experienced any adverse reaction. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200301192	1						1	Medication error	FLU3~EVANS VACCINES~765858~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230649	12/10/2004		37.0			F	10/08/2004	A report was received from a health care professional on 11/24/03 concerning a 37 year old female vaccinee who was inadvertently administered frozen Fluvirin vaccine on an unspecified date. On an unknown date, the vaccinee inadvertently received Fluvirin, which had been left adjacent to a freezer compartment and was subsequently frozen. The vaccinee will be advised to receive Fluvirin again in 3 weeks time. It was not reported if the vaccinee had experienced any adverse reaction. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200301193	1						1	Medication error	FLU3~EVANS VACCINES~765858~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230650	12/10/2004		64.0			M	10/08/2004	A report was received from a health care professional on 11/24/03 concerning a 64 year old male vaccinee who was inadvertently administered frozen Fluvirin vaccine on an unreported date. On an unknown date, the vaccinee inadvertently received Fluvirin, which had been left adjacent to a freezer compartment and was subsequently frozen. The vaccinee will be advised to receive Fluvirin again in 3 weeks time. It was not reported if the vaccinee had experienced any adverse reaction. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200301194	1						1	Medication error	FLU3~EVANS VACCINES~765858~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230651	12/10/2004		60.0			F	10/08/2004	A report was received from a health care professional on 11/24/03 concerning a 60 year old female vaccinee who was inadvertently administered frozen Fluvirin on an unreported date. On an unknown date, the vaccinee inadvertently received Fluvirin, which had been left adjacent to a freezer compartment and was subsequently frozen. The vaccinee will be advised to receive Fluvirin again in 3 weeks time. It was not reported if the vaccinee had experienced any adverse reaction. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200301195	1						1	Medication error	FLU3~EVANS VACCINES~765858~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230652	12/10/2004		69.0			F	10/08/2004	A report was received from a health care professional on 11/24/03 concerning a 69 year old female vaccinee who was inadvertently administered frozen Fluvirin vaccine on an unreported date. On an known date, the vaccinee inadvertently received Fluvirin, which had been left adjacent to a freezer compartment and was subsequently frozen. The vaccinee will be advised to receive Fluvirin again in 3 weeks time. It was not reported if the vaccinee had experienced any adverse reaction. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200301196	1						1	Medication error	FLU3~EVANS VACCINES~765858~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230653	12/10/2004		44.0	44		F	10/08/2004	A report was received from a health care professional on 11/26/03 concerning a 44 year old female vaccinee who was administered Fluvirin vaccine in the buttocks on 11/5/03. On 11/5/03, the vaccinee requested Fluvirin be administered in the buttocks instead of the deltoid. The vaccinee had not exhibited any signs or symptoms of an adverse event at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/05/2003	11/05/2003	0		UNK	UNK	NONE		NONE		PJP200301198	1						1	Medication error	FLU3~EVANS VACCINES~765751~UNK~IM~GM~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230654	12/10/2004		46.0	45		F	10/08/2004	A report was received from a health care professional on 11/26/03 concerning a 45 year old female vaccinee who was administered Fluvirin vaccine in the buttocks on 10/30/03. On 10/30/03, the vaccinee requested Fluvirin be administered in the buttocks instead of the deltoid. The vaccine had not exhibited any signs or symptoms of an adverse event at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/30/2003	10/30/2003	0		UNK	UNK	NONE		NONE		PJP200301199	1						1	Medication error	FLU3~EVANS VACCINES~765705~UNK~IM~GM~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230655	12/10/2004		1.2			F	10/08/2004	A report was received from a health care professional on 11/26/03 concerning a 14 month old female vaccinee who was inadvertently administered Fluvirin vaccine 11/26/03. On 11/26/03, the vaccinee was administered 0.25ml Fluvirin. No adverse effects were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200301200	1						1	Medication error	FLU3~EVANS VACCINES~766051~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230656	12/10/2004		66.0			F	10/08/2004	A report was received from a health care professional concerning a 66 year old female vaccinee who inadvertently received expired Fluvirin SC on 11/10/03. On 11/10/03, the vaccinee inadvertently received expired Fluvirin SC. The vaccinee had not experienced any adverse event at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/10/2003	11/10/2003	0		UNK	UNK	NONE		NONE		PJP200301201	1						1	Medication error	FLU3~EVANS VACCINES~E33142GA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230657	12/10/2004		75.0			F	10/08/2004	A report was received from a health care professional on 11/14/03 concerning a 75 year old female vaccinee who inadvertently received expired Fluvirin SC on 11/10/03. On 11/10/03, the vaccinee inadvertently received expired Fluvirin SC. The vaccinee did not experience any adverse events at the time of this report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/10/2003	11/10/2003	0		UNK	UNK	NONE		NONE		PJP200301202	1						1	Medication error	FLU3~EVANS VACCINES~E33142GA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230658	12/10/2004		76.0			M	10/08/2004	A report was received from a health care professional on 11/14/03 concerning a 73 year old male vaccinee who inadvertently received expired Fluvirin SC on 11/10/03. On 11/10/03, the vaccinee inadvertently received expired Fluvirin SC. The vaccinee did not experience any adverse events at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/10/2003	11/10/2003	0		UNK	UNK	NONE		NONE		PJP200301203	1						1	Medication error	FLU3~EVANS VACCINES~E33142GA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230659	12/10/2004		51.0			M	10/08/2004	A report was received from a health care professional on 11/14/03, concerning a 51 year old male vaccinee who inadvertently received expired Fluvirin SC on 11/11/03. On 11/11/03, the vaccinee inadvertently received expired Fluvirin SC. The vaccinee did not experience any adverse events at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/11/2003	11/11/2003	0		UNK	UNK	NONE		NONE		PJP200301204	1						1	Medication error	FLU3~EVANS VACCINES~E33142GA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230660	12/10/2004		49.0			M	10/08/2004	A report was received from a health care professional on 11/14/03 concerning a 49 year old male vaccinee who inadvertently received expired Fluvirin SC on 11/11/03. On 11/11/03, the vaccinee inadvertently received expired Fluvirin SC. The vaccinee did not experience any adverse events at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/11/2003	11/11/2003	0		UNK	UNK	NONE		NONE		PJP200301205	1						1	Medication error	FLU3~EVANS VACCINES~E33142GA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230661	12/10/2004		82.0			M	10/08/2004	A report was received from a health care professional on 11/14/03 concerning an 82 year old male vaccinee who inadvertently received expired Fluvirin SC on 11/11/03. On 11/11/03, the vaccinee inadvertently received expired Fluvirin SC. The vaccinee did not experience any adverse events at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/11/2003	11/11/2003	0		UNK	UNK	NONE		NONE		PJP200301206	1						1	Medication error	FLU3~EVANS VACCINES~E33142GA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230662	12/10/2004		74.0			M	10/08/2004	A report was received from a health care professional on 11/14/03 concerning a 74 year old male vaccinee who received expired Fluvirin SC on 11/11/03. On 11/11/03, the vaccine received expired Fluvirin SC. The vaccinee had not experienced any adverse events at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/11/2003	11/11/2003	0		UNK	UNK	NONE		NONE		PJP200301207	1						1	Medication error	FLU3~EVANS VACCINES~E33142GA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230663	12/10/2004		3.0			F	10/08/2004	A report was received from a health care professional on 11/26/03 concerning a 3 year old female vaccinee who was inadvertently administered Fluvirin vaccine 11/26/03. On 11/26/03, the vaccinee was administered 0.25ml Fluvirin. No adverse effects were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/26/2003	11/26/2003	0		UNK	UNK	NONE		NONE		PJP200301208	1						1	Medication error	FLU3~EVANS VACCINES~766051~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230664	12/10/2004		1.98	1	1	F	10/08/2004	A report was received from a health care professional on 10/24/03 concerning 3 vaccinees of unknown gender less than 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date, 3 vaccinees less than 4 years of age inadvertently received Fluvirin. It was unknown at the time of the report whether or not the vaccinees had exhibited any signs or symptoms of an adverse reaction. There was insufficient information to determine the reporter's causality assessment. Update 11/24/03: Further information was received from a health care professional on 11/24/03 indicating the vaccinee was a 2 year old female who inadvertently received 0.25ml Fluvirin vaccine on 10/21/03. On 10/21/03 the vaccinee inadvertently received Fluvirin. No adverse events were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/21/2003	10/21/2003	0		UNK	UNK	NONE		NONE		PJP200301210	1						1	Medication error	FLU3~EVANS VACCINES~765878~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230665	12/10/2004		0.77	0	.8	M	10/08/2004	A report was received from a health care professional on 10/24/03 concerning 3 vaccinees of unknown gender less than 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date 3 vaccinees less than 4 years of age inadvertently received Fluvirin. It was unknown at the time of the report whether or not the vaccinees had exhibited any signs or symptoms of an adverse reaction. There was insufficient information to determine the reporter's causality assessment. Update 11/24/03: Further information was received from a health care professional on 11/24/03 indicating that the vaccinee was a 10 month old male who inadvertently received 0.25ml Fluvirin vaccine on 10/13/03. On 10/13/03, the vaccinee inadvertently received Fluvirin. No adverse events were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/13/2003	10/13/2003	0		UNK	UNK	NONE		NONE		PJP200301211	1						1	Medication error	FLU3~EVANS VACCINES~765878~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230666	12/10/2004		2.0	2	.3	M	10/08/2004	A report was received from a health care professional on 10/24/03 concerning 3 vaccinees of unknown gender less than 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date 3 vaccinees less than 4 years of age inadvertently received Fluvirin. It was unknown at the time of the report whether or not the vaccinees had exhibited any signs or symptoms of an adverse reaction. There was insufficient information to determine the reporter's causality assessment. Update 11/24/03: Further information was received from a health care professional on 11/24/03 indicating that the vaccinee was a 27 month old male who inadvertently received 0.25ml Fluvirin vaccine on 11/3/03. On 11/3/03, the vaccinee inadvertently received Fluvirin. No adverse events were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/03/2003	11/03/2003	0		UNK	UNK	NONE		NONE		PJP200301212	1						1	Medication error	FLU3~EVANS VACCINES~765878~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230667	12/10/2004		4.0	3		M	10/08/2004	A report was received from a health care professional on 10/24/03 concerning 3 vaccinees of unknown gender less than 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date 3 vaccinees less than 4 years of age inadvertently received Fluvirin. It was unknown at the time of the report whether or not the vaccinees had exhibited any signs or symptoms of an adverse reaction. There was insufficient information to determine the reporter's causality assessment. Update 11/24/03: Further information was received from a health care professional on 11/24/03 indicating that the vaccinee was a 3 year old male who inadvertently received 0.25ml Fluvirin vaccine on 11/3/03. On 11/3/03 the vaccinee inadvertently received Fluvirin. No adverse events were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/03/2003	11/03/2003	0		UNK	UNK	NONE		NONE		PJP200301213	1						1	Medication error	FLU3~EVANS VACCINES~765878~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230668	12/10/2004					U	10/08/2004	A report was received from a health care professional on 12/1/03 concerning an unspecified number of vaccinees less than 4 years of age and of unknown sex who inadvertently received Fluvirin on approximately 11/17/03. On approximately 11/17/03 multiple vaccinees less than 4 years of age inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/17/2003	11/17/2003	0		UNK	UNK	NONE		NONE		PJP200301215	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230669	12/10/2004					F	10/08/2004	A report was received from a health care professional on 12/2/03 concerning a female vaccine (age unspecified) who experienced local pain and later developed right shoulder arthritis/bursitis after she received Fluvirin on 10/28/03. On 10/28/03, the vaccinee received Fluvirin into the right arm 1cm below the right shoulder joint. The vaccinee experienced local pain at the time of the vaccination. The vaccinee later developed right shoulder arthritis/bursitis that had not resolved at the time of reporting. The vaccinee was referred to an orthopedic surgeon for follow up. The reporter stated that the Fluvirin injection might possibly have been administered into the shoulder joint. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/28/2003	10/28/2003	0		UNK	UNK	NONE		Left mastectomy.		PJP200301216	1						1	Arthritis; Bursitis; Pain	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230670	12/10/2004		65.0			M	10/08/2004	A report was received from a health care professional on 12/02/03 concerning a 65 year old male vaccinee who inadvertently received two doses of Fluvirin on unspecified dates, two weeks apart. On unspecified dates a 65 year old male vaccinee inadvertently received two doses of Fluvirin, two weeks apart. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200301217	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230671	12/10/2004					U	10/08/2004	A report was received from a health care professional on 12/2/03 concerning a vaccine, demography unknown who inadvertently received Fluvirin via the SC route on 12/2/03. On 12/2/03, the vaccinee inadvertently received Fluvirin via the SC route. No adverse symptoms were reported at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/02/2003	12/02/2003	0		UNK	UNK	NONE		NONE		PJP200301218	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230672	12/10/2004					U	10/08/2004	A report was received from a health care professional on 12/2/03 concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on unspecified dates. On unspecified dates until 12/1/03 vaccinees inadvertently received Fluvirin. The vaccinees did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/01/2003	12/01/2003	0		UNK	UNK	NONE		NONE		PJP200301219	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230673	12/10/2004					U	10/08/2004	A report was received from a health care professional on 12/2/03 concerning 7 vaccinees under 4 years of age who inadvertently received Fluvirin on unspecified dates. On unspecified dates, the vaccinees inadvertently received Fluvirin. The vaccinees did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200301220	1						1	Medication error	FLU3~EVANS VACCINES~765706~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230674	12/10/2004		7.0	7		F	10/08/2004	A report was received from a health care professional on 12/2/03 concerning a 7 year old female vaccinee who inadvertently received 0.25ml Fluvirin on 12/1/03. On 12/1/03, the vaccinee inadvertently received 0.25ml instead of 0.5ml of Fluvirin. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Further information was received from a health care professional indicating that the vaccinee was vaccinated again with the correct dose of Fluvirin on 12/11/03. The vaccinee did not experience any adverse reaction at the time of the report. Follow up received 6/30/04 reporting no adverse events after the vaccinee was revaccinated on 12/11/04.									U	12/01/2003	12/01/2003	0		UNK	UNK	NONE		NONE		PJP200301221	1						1	Medication error	FLU3~EVANS VACCINES~765703~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230675	12/10/2004		47.0			F	10/08/2004	A report was received from a health care professional on 12/2/03 concerning a 47 year old female vaccinee who inadvertently received Fluvirin via the IM route in the buttocks on 11/21/03. On 11/21/03, the vaccinee received Fluvirin IM in the buttocks. The vaccinee had surgery on one arm and she was having a problem with her other arm, and therefore requested and received Fluvirin in her buttocks. No adverse symptoms were reported at the time reporting. There was insufficient information to determine the reporter's causality assessment. Update 4/13/04: Follow up information from a health care professional indicated that the vaccinee did not experience any adverse events and did not require repeat vaccination with Fluvirin. No follow up pending, all information received.									U	11/21/2003	11/21/2003	0		UNK	UNK	NONE		NONE		PJP200301222	1						1	Medication error	FLU3~EVANS VACCINES~765751~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230676	12/10/2004		3.0	2	.8	F	10/08/2004	A report was received from a health care professional on 12/2/03 concerning an unspecified number (approximately 5 to 6) vaccinees under 4 years of age who inadvertently received Fluvirin on unspecified dates. On unspecified dates, the vaccinees inadvertently received Fluvirin 0.5ml IM. The vaccine did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1/20/04: A follow up report was received from a health care professional concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 11/25/03. On 11/25/03 the vaccinee inadvertently received Fluvirin. No adverse effects were reported at the time of reporting. No follow up pending, all information received.									U	11/25/2003	11/25/2003	0		UNK	UNK	NONE		NONE		PJP200301223	1						1	Medication error	FLU3~EVANS VACCINES~766053~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230677	12/10/2004		1.61	1	.6	M	10/08/2004	A report was received from a health care professional on 12/2/03 concerning a 19 month male vaccinee who inadvertently received Fluvirin on 11/30/03. On 11/30/03, a vaccinee under 4 years of age inadvertently received Fluvirin. At the time of the report no adverse had been reported. There was insufficient information to determine the reporter's causality assessment. Update 4/13/04: Follow up information received from a health care professional indicated that the vaccinee received a second dose of Fluvirin on an unspecified date. The vaccinees' parents were contacted in January 2004 and stated that the vaccinee did not experience any adverse events. No follow up pending, all information received.									U	11/30/2003	11/30/2003	0		UNK	UNK	NONE		NONE		PJP200301224	1						1	Medication error	FLU3~EVANS VACCINES~765500~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230678	12/10/2004		3.0	3		F	10/08/2004	A report was received from a health care professional on 12/2/03 concerning a 3 year old female vaccinee who received a dose of Fluzone on 10/29/03 and the inadvertently received a dose of Fluvirin instead of a second dose of Fluzone on 11/28/03. On 10/29/03 a female vaccinee received a dose of Fluzone and on 11/28/03 the vaccinee inadvertently received a dose of Fluvirin instead of a second dose of Fluzone. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 3/10/04: Follow up information received from a health care professional indicated that the vaccinee also received an accidental overdose of 0.5ml of Fluvirin. No adverse events have been reported to date. No follow up pending, all information received.									U	11/28/2003	11/28/2003	0		UNK	UNK			NONE		PJP200301225	1						1	Medication error	FLU3~EVANS VACCINES~765705~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230679	12/10/2004		1.97	1	1	M	10/08/2004	A report was received from a health care professional on 12/3/03 concerning eight vaccinees of unspecified sex and under 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date, eight vaccinees under 4 years of age inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality. Update 1/20/04: Follow up information received from a health care professional indicated that a 2 year old male vaccinee inadvertently received Fluvirin on 11/24/03. No follow up pending.									U	11/24/2003	11/24/2003	0		UNK	UNK	NONE		NONE		PJP200301226	1						1	Medication error	FLU3~EVANS VACCINES~765497~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230680	12/10/2004		0.58	0	.6	M	10/08/2004	A report was received from a health professional on 12/3/03 concerning a 6 month old male vaccinee who was inadvertently administered Fluvirin on 12/2/03. On 12/3/03, the vaccinee inadvertently received 0.25ml of Fluvirin. No adverse effects were reported at time of report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/02/2003	12/02/2003	0		UNK	UNK	NONE		NONE		PJP200301227	1						1	Medication error	FLU3~EVANS VACCINES~765756~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230681	12/10/2004		53.0			F	10/08/2004	A report was received from a health care professional on 12/3/03 concerning a 53 year old female vaccinee who experienced muscle aches, pain, a dull, achy pain in her left arm and a twinge of pain in her left arm and is unable to sleep on her left side on 11/7/03 after receiving 0.5ml Fluvirin vaccine on the same day. On 11/7/03, the vaccinee experienced muscle aches and pain following administration of Fluvirin. Soon after administration the vaccinee experienced a dull, achy pain in her left arm. The vaccinee took 3 Advil and the pain and achiness subsided. The vaccinee continues to experience discomfort in the left deltoid muscle. However, she has not experienced fever and the injection has not become red or swollen. When the vaccinee is not moving, she experiences a dull ache in her left arm and when she moves she feels a twinge of pain in her arm. The vaccinee cannot sleep on her left side due to the pain in her left arm. The vaccinee is not taking any other medications and has received the flu vaccine in the past without any complications following vaccination. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/07/2003	11/07/2003	0		UNK	UNK	NONE		Allergies to Flexeril, Compazine and Bactrim.		PJP200301228	1						1	Discomfort; Myalgia; Pain; Sleep disorder	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230682	12/10/2004		51.0	50		F	10/08/2004	A report was received from a health care professional on 12/3/03 concerning a 50 year old female vaccinee who inadvertently received Fluvirin SC on 10/23/03. On 10/23/03, a female vaccinee inadvertently received Fluvirin SC. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/23/2003	10/23/2003	0		UNK	UNK	NONE		NONE		PJP200301229	1						1	Medication error	FLU3~EVANS VACCINES~766050~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230683	12/10/2004		2.0	2	.1	M	10/08/2004	A report was received from a health care professional on 12/3/03 concerning a 2 year old male vaccinee who inadvertently received Fluvirin on the same day. On 12/3/03 a 2 year old male vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality. Follow up pending.									U	12/03/2003	12/03/2003	0		UNK	UNK	NONE		NONE		PJP200301230	1						1	Medication error	FLU3~EVANS VACCINES~765873~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230684	12/10/2004					U	10/08/2004	A report was received from a health care professional on 12/3/03 concerning approximately 2-3 children of unknown sex and between the ages of 2 to 3 years who inadvertently received Fluvirin on an unspecified date. On an unspecified date approximately 2-3 children between the ages of 2 to 3 years inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200301231	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230685	12/10/2004		40.0			F	10/08/2004	A report was received from a health care professional on 12/3/03 concerning a female vaccinee in her 40's who developed a vaginal ulcer with symptoms to burning on urination and urgency on 11/13/03 after receiving Fluvirin vaccine on 11/12/03. Within 24 hours of receiving Fluvirin on 11/12/03 the vaccinee developed a vaginal ulcer with symptoms of burning on urination and urgency. The vaccinee was seen by the OB/GYN and was prescribed a vaginal anti-fungal cream for 4 days. The vaccinees vaginal ulcer resolved following completion of the anti-fungal therapy, however, she still complains of burning on urination and a feeling of urgency. The vaccinee was restarted on the vaginal anti-fungal cream and continues this therapy. The vaccinee had a test for yeast yielding negative results. Update 1/24/04: A follow up report was received from a health care professional indicating that a urologist treated the vaccine. She was given multiple medications including anti-inflammatories and antibiotics. The urologist felt that the vaccinee had interstitial cystitis which had no relationship to the flu vaccine. At the time of the follow up report the ulcer had disappeared but the urinary symptoms were unresolved. Update 2/23/04: A follow up report was received from a health care professional indicating that the vaccinee has been diagnosed with interstitial cystitis and continues to have symptoms. No follow up pending, all information received.									U	11/12/2003	11/12/2003	0		UNK	UNK	NONE		NONE		PJP200301232	1						1	Cystitis interstitial; Dysuria; Micturition urgency; Vaginal ulceration	FLU3~EVANS VACCINES~765952~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230686	12/10/2004					F	10/08/2004	A report was received from a health care professional on 12/3/03 concerning a female vaccinee of unspecified age who inadvertently received Fluvirin SC on 12/2/03. On 12/2/03 the vaccinee inadvertently received Fluvirin SC with a 27G needle instead of IM. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 4/16/04: Follow up information received from an unidentified source indicated that the adult vaccinee did not experience any adverse events. No follow up pending, all information received.									U	12/02/2003	12/02/2003	0		UNK	UNK	NONE		NONE		PJP200301233	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230687	12/10/2004		30.0			F	10/08/2004	A report was received from a health care professional on 12/3/03 concerning a 30 year old female vaccinee who inadvertently received expired Fluvirin vaccine on 12/3/03. On 12/3/03 the vaccinee was administered 2002-2003 Fluvirin. No adverse events were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/03/2003	12/03/2003	0		UNK	UNK	NONE		NONE		PJP200301234	1						1	Medication error	FLU3~EVANS VACCINES~E35452HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230688	12/10/2004		31.0			M	10/08/2004	A report was received from a health care professional on 12/3/03 concerning a 31 ear old male vaccinee who inadvertently received expired Fluvirin vaccine on 12/3/03. On 12/3/03 the vaccinee was administered 2002-2003 Fluvirin. No adverse events were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/03/2003	12/03/2003	0		UNK	UNK	NONE		NONE		PJP200301235	1						1	Medication error	FLU3~EVANS VACCINES~E35452HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230689	12/10/2004		2.0			U	10/08/2004	A report was received from a health care professional on 12/4/03 concerning an unknown number of 2 year old vaccinees of unknown sex who inadvertently received Fluvirin on an unspecified date. On an unspecified date, an unknown number 2 year old vaccinees inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200301236	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230690	12/10/2004		1.25			M	10/08/2004	A report was received from a member of staff for a health care professional on 12/5/03 concerning a 15 month old male vaccinee who inadvertently received 0.25ml Fluvirin vaccine on 12/4/03. On 12/4/03 the vaccinee received Fluvirin. No adverse symptoms occurred. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/04/2003	12/04/2003	0		UNK	UNK	NONE		NONE		PJP200301237	1						1	Medication error	FLU3~EVANS VACCINES~765875~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230691	12/10/2004		3.0			M	10/08/2004	A report was received from a member of staff for a health care professional on 12/5/03 concerning a 3 year old male who inadvertently received 0.5ml Fluvirin vaccine on 12/3/03. On 12/3/03 the vaccinee received Fluvirin. No adverse symptoms occurred. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/03/2003	12/03/2003	0		UNK	UNK	NONE		NONE		PJP200301238	1						1	Medication error	FLU3~EVANS VACCINES~765875~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230692	12/10/2004		1.32	1	.3	F	10/08/2004	A report was received from a health care professional on 12/4/03 concerning a 16 month old female vaccinee who was administered a single dose of Fluvirin vaccine on 12/2/03. On 12/2/03 the vaccinee received Fluvirin. The vaccinee did not exhibit any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 2/4/04: A follow up report was received from a health care professional concerning a one and a half year old vaccinee who received Fluvirin on 12/1/03. No adverse events were reported at the time of reporting. No follow up pending, all information received.									U	12/01/2003	12/01/2003	0		UNK	UNK	NONE		NONE		PJP200301239	1						1	Medication error	FLU3~EVANS VACCINES~765178~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230693	12/10/2004					U	10/08/2004	A report was received from a health care professional on 12/4/03 concerning an unknown number of children less than 4 years of age and of unknown sex who inadvertently received Fluvirin on an unspecified date. On an unspecified date, an unknown number of children less than 4 years of age inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. No follow up pending, all information received.									U					UNK	UNK	NONE		NONE		PJP200301240	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230694	12/10/2004		71.0	70		M	10/08/2004	A report was received from a health care professional on 12/4/03 concerning a 70 year old male vaccinee who experienced headache and fatigue an unspecified length of time following administration of Fluvirin on 12/4/03. The vaccinee inadvertently received two doses of influenza vaccine, one dose of influenza vaccine was administered on an unspecified date several months earlier and Fluvirin was administered on 12/4/03. On 12/4/03, approximately 8 hours after administration of Fluvirin the vaccinee experienced headache and fatigue. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/04/2003	12/04/2003	0		UNK	UNK	NONE		NONE		PJP200301241	1						1	Fatigue; Headache; Medication error	FLU3~EVANS VACCINES~765500~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230695	12/10/2004					U	10/08/2004	A report was received from a health care professional on 12/4/03 concerning 3 to 4 children of unknown sex and under 4 years of age who inadvertently received Fluvirin on approximately 10/15/03. On approximately 10/15/03, 3 to 4 children inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/15/2003	10/15/2003	0		UNK	UNK	NONE		NONE		PJP200301242	1						1	Medication error	FLU3~EVANS VACCINES~765851~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230696	12/10/2004					F	10/08/2004	A report was received from a health care professional on 12/4/03 concerning a female vaccinee, aged between 22-24 years who developed swelling of the injection site following administration of Fluvirin on an unknown date in either late October 2003 or early November 2003. On an unknown date in either late October 2003 or early November 2003 the vaccinee developed swelling at the injection site following administration of Fluvirin. The swelling became enlarged from the elbow to the shoulder. The reporter also suspected that the adverse event had resolved at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									Y					UNK	UNK	NONE		NONE		PJP200301243	1						1	Injection site swelling	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230697	12/10/2004		2.0	2	.1	M	10/08/2004	A report was received from a health care professional on 12/4/03 concerning a 2 year old vaccinee of unknown sex who inadvertently received Fluvirin vaccine on 12/3/03. On 12/3/03 the vaccinee received Fluvirin instead of Fluzone. No side effects were noted at the time of administration to the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up 6/28/04, vaccine identified as a 2 year old male who received Fluvirin 0.25ml on 12/4/03. No adverse events have been reported.									U	12/04/2003	12/04/2003	0		UNK	UNK	NONE		NONE		PJP200301244	1						1	Medication error	FLU3~EVANS VACCINES~765855~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230698	12/10/2004		0.9	0	.9	F	10/08/2004	A report was received from a health care professional on 12/4/03 concerning an 11 month old vaccinee of unknown sex who inadvertently received Fluvirin vaccine on 12/3/03. On 12/3/03 the vaccinee received Fluvirin instead of Fluzone. No side effects were noted at the time of vaccine administration to the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up received on 6/28/04. An 11 month old female received 0.25ml Fluvirin on 11/6/03. No adverse effect were reported.									U	11/06/2003	11/06/2003	0		UNK	UNK	NONE		NONE		PJP200301245	1						1	Medication error	FLU3~EVANS VACCINES~765855~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230699	12/10/2004		0.71	0	.7	M	10/08/2004	A report was received from a health care professional on 12/5/03 concerning a male vaccinee aged 9.5 months who inadvertently received two doses of influenza vaccine on 12/2/03. On 12/2/03, a vaccinee received a dose of Fluzone and on the same day was inadvertently administered a dose of Fluvirin instead of Fluzone. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 2/16/04: The health care professional indicates that further information is not forthcoming from the vaccinee.									U	12/02/2003	12/02/2003	0		UNK	UNK	NONE		NONE		PJP200301246	1						1	Medication error	FLU3~EVANS VACCINES~766052~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230700	12/10/2004		3.0	3		M	10/08/2004	A report was received from a health care professional on 12/5/03 concerning a 3 year old male vaccinee who inadvertently received Fluvirin on 11/20/03. On 11/20/03 the vaccinee inadvertently received Fluvirin. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/20/2003	11/20/2003	0		UNK	UNK	NONE		NONE		PJP200301247	1						1	Medication error	FLU3~EVANS VACCINES~765667~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230701	12/10/2004		32.0	32		F	10/08/2004	A report was received from a health care professional on 12/5/03 concerning a 32 year old female vaccinee who inadvertently received Fluvirin ID instead of a TB skin test and experienced minor redness at the injection site on the same day. The vaccinee had already received influenza vaccine on approximately 11/25/03. On 12/5/03, the vaccinee inadvertently received Fluvirin ID instead of a TB skin test and experienced minor redness at the injection site on the same day. The health care professional mixed up the Fluvirin and TB PPD vials accidentally. The vaccinee had already received influenza vaccine on approximately 11/25/03. There was insufficient information to determine the reporter's causality assessment. Update 2/10/04: A follow up report was received from a health care professional indicating that the vaccinee had experienced non adverse events at the time of reporting. No follow up pending, all information received.									U	12/05/2003	12/05/2003	0		UNK	UNK			NONE		PJP200301248	1						1	Injection site erythema; Medication error	FLU3~EVANS VACCINES~765978~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230702	12/10/2004		2.0	2	.3	F	10/08/2004	A report was received from a health care professional on 12/5/03 concerning a 2 year old female vaccinee who inadvertently received Fluvirin on the same day. On 12/5/03 the vaccinee inadvertently received Fluvirin. At the time of the report, no adverse events have been reported. There was insufficient information to determine the reporter's causality assessment. No follow up pending.									U	12/05/2003	12/05/2003	0		UNK	UNK	NONE		NONE		PJP200301250	1						1	Medication error	FLU3~EVANS VACCINES~765980~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230703	12/10/2004		2.0			F	10/08/2004	A report was received from a health care professional on 12/5/03 concerning a 2.5 year old female vaccine who inadvertently received Fluvirin on 5/12/03. On 5/12/03 a vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	05/12/2003	05/12/2003	0		UNK	UNK	NONE		NONE		PJP200301251	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230704	12/10/2004		2.0			F	10/08/2004	A report was received from a health care professional on 12/5/03 concerning a 2 year old female vaccinee who inadvertently received Fluvirin on the same day. On 12/5/03, a vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 2/6/04: A follow up report was received from a health care professional indicating that the vaccinee received Fluzone on 1/5/04. No adverse effects were reported. Follow up pending.									U	12/05/2003	12/05/2003	0		UNK	UNK	NONE		NONE		PJP200301252	1						1	Medication error	FLU3~EVANS VACCINES~765980~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230705	12/10/2004		2.0			F	10/08/2004	A report was received from a health care professional on 12/5/03 concerning a 2 year old male vaccinee who inadvertently received 0.5ml Fluvirin vaccine on an unspecified date. On an unspecified date the vaccinee received Fluvirin. At the time of the report no adverse reaction was reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200301253	1						1	Medication error	FLU3~EVANS VACCINES~766054~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230706	12/10/2004		2.0			M	10/08/2004	A report was received from a health care professional on 12/5/03 concerning a 2 year old male vaccinee who inadvertently received 0.5ml Fluvirin vaccine on an unspecified date. On an unspecified date the vaccinee received Fluvirin. At the time of the report no adverse reaction was reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200301254	1						1	Medication error	FLU3~EVANS VACCINES~766054~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230707	12/10/2004		0.76	0	.8	F	10/08/2004	A report was received from a health care professional on 12/6/03 concerning a 9 month old female vaccine who inadvertently received Fluvirin vaccine on 12/5/03. On 12/5/03 the vaccinee received Fluvirin. At the time of the report no adverse symptoms were reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/05/2003	12/05/2003	0		UNK	UNK	NONE		NONE		PJP200301255	1						1	Medication error	FLU3~EVANS VACCINES~766045~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230708	12/10/2004		1.84	1	.8	F	10/08/2004	A report was received from a health care professional on 12/6/03 concerning a 18 month old female vaccinee who inadvertently received Fluvirin vaccine on 12/3/03. On 12/3/03 the vaccinee received Fluvirin. At the time of the report no adverse symptoms were reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/03/2003	12/03/2003	0		UNK	UNK	NONE		NONE		PJP200301256	1						1	Medication error	FLU3~EVANS VACCINES~766045~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230709	12/10/2004		1.48	1	.5	M	10/08/2004	A report was received from a health care professional on 12/8/03 concerning an 18 month old male vaccinee who inadvertently received Fluvirin on the same day. On 12/8/03 the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up received 6/1/04, no adverse experience reported.									U	12/08/2003	12/08/2003	0		UNK	UNK	NONE		NONE		PJP200301257	1						1	Medication error	FLU3~EVANS VACCINES~765980~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230710	12/10/2004		4.0	3		F	10/08/2004	A report was received from a health care professional on 12/8/03 concerning a 2 year old female vaccinee who inadvertently received Fluvirin instead of Fluzone on the same day. On 12/8/03, the vaccinee inadvertently received Fluvirin instead of Fluzone. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 4/16/04: Follow up information received from a health care professional indicated that a 3 year old vaccinee inadvertently received 0.25ml Fluvirin on 11/28/03. No adverse events have been reported to date. No follow up pending, all information received.									U	11/28/2003	11/28/2003	0		UNK	UNK	NONE		NONE		PJP200301258	1						1	Medication error	FLU3~EVANS VACCINES~766050~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230711	12/10/2004		1.42	1	.4	F	10/08/2004	A report was received from a health care professional on 12/8/03 concerning five children of unspecified sex and aged between 8 months and 3 years of age who inadvertently received Fluvirin on 12/6/03. On 12/6/03, five children inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 3/8/04: Follow up information received from a health care professional indicated that a 1 year old female vaccinee inadvertently received Fluvirin on 12/6/03. No adverse reactions have been reported to date. No follow up pending, all information received.									U	12/06/2003	12/06/2003	0		UNK	UNK	NONE		NONE		PJP200301259	1						1	Medication error	FLU3~EVANS VACCINES~765749~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230712	12/10/2004		4.0	3		M	10/08/2004	A report was received from a health care professinal on 12/8/03 concerning a 3 and a half year old male vaccinee who inadvertently received Fluvirin instead of Fluzone on the same day. On 12/8/03, the vaccinee inadvertently received Fluvirin instead of Fluzone. At the time of the report, no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 2/9/04: A follow up report was received from a health care professional indicating that the vaccinee had experienced no adverse events. The vaccinee received Fluzone on 12/22/03. No follow up pending, all information received.									U	12/08/2003	12/08/2003	0		UNK	UNK	NONE		NONE		PJP200301260	1						1	Medication error	FLU3~EVANS VACCINES~766055~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230713	12/10/2004					U	10/08/2004	A report was received from a health care professional on 12/8/03 concerning an unknown number of children aged between 4 and 8 years of age and of unspecified sex who inadvertently received 0.25ml Fluvirin on an unknown date. On an unknown date, an unspecified number of children aged between 4 and 8 years of age inadvertently received 0.25ml Fluvirin instead of 0.5ml. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200301261	1						1	Medication error	FLU3~EVANS VACCINES~766053~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230714	12/10/2004		3.0	3		F	10/08/2004	A report was received from a health care professional on 10/23/03 concerning approximately 10 pediatric vaccinees less than 4 years old, of unknown sex, who were inadvertently administered Fluvirin between 10/8/03 and approximately 10/22/03. Between 10/8/03 and approximately 10/22/03, approximately 10 pediatric vaccinees less than 4 years old were inadvertently administered Fluvirin vaccine. No adverse reactions were recorded at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 12/9/03: A follow up report was received from a health care professional indicating that a 3 year old female vaccinee inadvertently received Fluvirin on 10/8/03. On 10/8/03, a 3 year old female vaccinee inadvertently received 0.25ml Fluvirin. At the time of reporting the vaccinee did not exhibit any adverse symptoms. No follow up pending. All information received.									U	10/08/2003	10/08/2003	0		UNK	UNK	NONE		NONE		PJP200301263	1						1	Medication error	FLU3~EVANS VACCINES~765703~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230715	12/10/2004		1.72	1	.7	F	10/08/2004	A report was received from a health care professional on 10/23/03 concerning approximately 10 pediatric vaccinees less than 4 years old, of unknown sex, who were inadvertently administered Fluvirin vaccine between 10/8/03 and approximately 10/22/03. Between 10/8/03 and approximately 10/22/03, approximately 10 pediatric vaccinees less than 4 years old were inadvertently administered Fluvirin vaccine. No adverse reactions were recorded at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 12/9/03: A follow up report was received from a health care professional indicating that a 1 year old female vaccinee inadvertently received Fluvirin on 10/8/03. On 10/8/03 the vaccinee inadvertently received 0.5ml Fluvirin. At the time of reporting, the vaccinee did not exhibit any adverse symptoms. No follow up pending. All information received.									U	10/08/2003	10/08/2003	0		UNK	UNK	NONE		NONE		PJP200301264	1						1	Medication error	FLU3~EVANS VACCINES~765703~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230716	12/10/2004		1.41	1	.4	M	10/08/2004	A report was received from a health care professional on 10/23/03 concerning approximately 10 pediatric vaccinees less than 4 years old, of unknown sex, who were inadvertently administered Fluvirin vaccine between 10/8/03 and approximately 10/22/03. Between 10/8/03 and approximately 10/22/03, approximately 10 pediatric vaccinees less than 4 years old were inadvertently administered Fluvirin vaccine. No adverse reactions were recorded at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 12/9/03: A follow up report was received from a health care professional indicating that a one year old male vaccinee inadvertently received Fluvirin on 10/14/03. On 10/14/03 the vaccinee inadvertently received 0.25ml Fluvirin. At the time of reporting, the vaccinee did not exhibit any adverse symptoms. No follow up pending. All information received.									U	10/14/2003	10/14/2003	0		UNK	UNK	NONE		NONE		PJP200301265	1						1	Medication error	FLU3~EVANS VACCINES~765703~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230717	12/10/2004		1.23	1	.2	M	10/08/2004	A report was received from a health care professional on 10/23/03 concerning approximately 10 pediatric vaccinees less than 4 years old, of unknown sex, who were inadvertently administered Fluvirin vaccine between 10/8/03 and approximately 10/22/03. Between 10/08/03 and approximately 10/22/03, approximately 10 pediatric vaccinees less than 4 years old were inadvertently administered Fluvirin vaccine. No adverse reactions were recorded at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 12/9/03: A follow up report was received from a health care professional indicating that a one year old male vaccinee was inadvertently received Fluvirin on 10/15/03. On 10/15/03 the vaccinee inadvertently received 0.25ml Fluvirin. At the time of reporting, the vaccinee did not exhibit any adverse symptoms. No follow up pending. All information received.									U	10/15/2003	10/15/2003	0		UNK	UNK	NONE		NONE		PJP200301266	1						1	Medication error	FLU3~EVANS VACCINES~765851~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230718	12/10/2004		0.98	0	1	M	10/08/2004	A report was received from a health care professional on 10/23/03 concerning approximately 10 pediatric vaccinees less than 4 years old, of unknown sex, who were inadvertently administered Fluvirin vaccine between 10/8/03 and approximately 10/22/03. Between 10/8/03 and approximately 10/22/03, approximately 10 pediatric vaccinees less than 4 years old were inadvertently administered Fluvirin vaccine. No adverse reactions were recorded at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 12/9/03: A follow up report was received from a health care professional indicating that a one year old male vaccinee inadvertently received Fluvirin on 10/14/03. On 10/14/03 the vaccinee inadvertently received 0.25ml Fluvirin. At the time of reporting the vaccinee did not exhibit any adverse symptoms. No follow up pending. All information received.									U	10/14/2003	10/14/2003	0		UNK	UNK	UNK		UNK		PJP200301267	1						1	Medication error	FLU3~EVANS VACCINES~765703~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230719	12/10/2004		0.78	0	.8	M	10/08/2004	A report was received from a health care professional on 10/23/03 concerning approximately 10 pediatric vaccinees less than 4 years old of unknown sex, who were inadvertently administered Fluvirin vaccine between 10/8/03 and approximately 10/22/03. Between 10/8/03 and approximately 10/22/03, approximately 10 pediatric vaccinees less than 4 years old were inadvertently administered Fluvirin vaccine. No adverse reactions were recorded at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 12/9/03: A follow up report was received from a health care professional indicating that a 8 month old male vaccinee inadvertently received Fluvirin on 10/22/03. On 10/22/03 the male vaccinee inadvertently received 0.25ml Fluvirin. At the time of reporting the vaccinee did not exhibit any adverse symptoms. No follow up pending. All information received.									U	10/22/2003	10/22/2003	0		UNK	UNK	NONE		NONE		PJP200301268	1						1	Medication error	FLU3~EVANS VACCINES~765851~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230720	12/10/2004		1.55	1	.5	F	10/08/2004	A report was received from a healthcare professional on 10/23/03 concerning approximately 10 pediatric vaccinees less than 4 years old, of unknown sex, who were inadvertently administered Fluvirin vaccine between 10/8/03 and approximately 10/22/03. Between 10/8/03 and approximately 10/22/03, approximately 10 pediatric vaccinees less than 4 years old were inadvertently administered Fluvirin vaccine. No adverse reactions were recorded at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 12/9/03: A follow up report was received from a health care professional indicating that a 18 month old female vaccinee inadvertently received Fluvirin on 10/22/03. On 10/22/03 the vaccinee inadvertently received 0.25ml Fluvirin. At the time of reporting, the vaccinee did not exhibit any adverse symptoms. No follow up pending. All information received.									U	10/22/2003	10/22/2003	0		UNK	UNK	NONE		NONE		PJP200301269	1						1	Medication error	FLU3~EVANS VACCINES~765851~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230721	12/10/2004					M	10/08/2004	A report was received from a health care professional on 12/9/03 concerning a 13 or 14 year old male vaccinee who inadvertently received 1.0ml of Fluvirin on the same day. On 12/9/03, the vaccinee inadvertently received 1.0ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/09/2003	12/09/2003	0		UNK	UNK	NONE		NONE		PJP200301270	1						1	Medication error	FLU3~EVANS VACCINES~765499~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230722	12/10/2004					U	10/08/2004	A report was received from a health care professional on 12/9/03 concerning a group of 5 vaccinees aged between 4 to 9 years old and of unknown gender, who inadvertently received 0.25ml of Fluvirin on an unspecified date in November 2003. On an unspecified date in November 2003, the vaccinees inadvertently received 0.25ml of Fluvirin vaccine. No adverse symptoms had been reported at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/01/2003	11/01/2003	0		UNK	UNK	NONE		NONE		PJP200301271	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230723	12/10/2004		3.0			U	10/08/2004	A report was received from a health care professional on 12/9/03 concerning a group of 8-10 3 year old vaccinees who inadvertently received Fluvirin on 12/8/03. On 12/8/03 the vaccinees inadvertently received Fluvirin vaccine. No adverse symptoms had been reported at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/08/2003	12/08/2003	0		UNK	UNK	NONE		NONE		PJP200301272	1						1	Medication error	FLU3~EVANS VACCINES~765141~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230724	12/10/2004		2.0			M	10/08/2004	A report was received from a health care professional on 12/9/03 concerning a and a half year old male vaccinee who inadvertently received Fluvirin on 12/9/03. On 12/9/03, the vaccinee inadvertently received Fluvirin vaccine. No adverse symptoms had been reported at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/09/2003	12/09/2003	0		UNK	UNK	NONE		NONE		PJP200301273	1						1	Medication error	FLU3~EVANS VACCINES~765670~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230725	12/10/2004		14.0	13		M	10/08/2004	A report was received from a consumer on 12/9/03 concerning a 13 year old male vaccinee who inadvertently received 2 doses of Fluvirin on 12/9/03. On 12/9/03, the vaccinee inadvertently received 2 doses of Fluvirin vaccine. The vaccinee complained of tenderness at the site of injection. Follow up pending.									U	12/09/2003	12/09/2003	0		UNK	UNK	NONE		NONE		PJP200301274	1						1	Injection site pain; Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230726	12/10/2004		0.88	0	.9	M	10/08/2004	A report was received from a health care professional on 12/8/03 concerning a 10 month old male vaccinee who inadvertently received Fluvirin on 12/6/03. On 12/6/03, the vaccinee inadvertently received Fluvirin. No adverse symptoms had been reported at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/06/2003	12/06/2003	0		UNK	UNK	NONE		NONE		PJP200301275	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230727	12/10/2004		1.9			M	10/08/2004	A report was received from a health care professional on 12/9/03 concerning a 23 month old male vaccinee who inadvertently received Fluvirin on 12/5/03. On 12/5/03 the vaccinee inadvertently received 0.5ml Fluvirin IM. The vaccinee had not experienced any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 4/5/04: Follow up information received from a health care professional indicated that the vaccinee inadvertently received 0.25ml Fluvirin on 12/6/03 and 1/8/04. No adverse events have been reported to date. No follow up pending. All information received.									U	12/08/2003	12/08/2003	0		UNK	UNK	NONE		NONE		PJP200301276	1						1	Medication error	FLU3~EVANS VACCINES~765872~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230728	12/10/2004		1.6			F	10/08/2004	A report was received from a health care professional on 12/9/03 concerning a 1 year old female vaccinee who inadvertently received Fluvirin on 12/7/03. On 12/7/03, the vaccinee inadvertently received 0.5ml Fluvirin IM. The vaccinee had not experienced any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 4/5/04: Follow up information received from a health care professional indicated that a 19 month old female vaccinee inadvertently received 0.25ml Fluvirin on 12/7/03 and 1/12/04. No adverse events have been reported to date. No follow up pending. All information received.									U	12/07/2003	12/07/2003	0		UNK	UNK	NONE		NONE		PJP200301277	1						1	Medication error	FLU3~EVANS VACCINES~765872~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230729	12/10/2004					F	10/08/2004	A report was received from a health care professional on 12/9/03 concerning a female vaccinee between 4 and 8 years of age who inadvertently received a sub-optimal dose of Fluvirin on an unspecified date in early December 2003. On an unspecified date in early December 2003, the vaccinee received half of the recommended dose of Fluvirin. It was not reported whether or not the vaccinee had experienced any adverse events at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/01/2003	12/01/2003	0		UNK	UNK	NONE		NONE		PJP200301278	1						1	Medication error	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0230730	12/10/2004					F	10/08/2004	A report was received from a health care professional on 12/9/03 concerning a female vaccinee between 4 and 8 years of age who inadvertently received a sub-optimal dose of Fluvirin on an unspecified date in early December 2003. On an unspecified date in early December 2003, the vaccinee received half of the recommended dose of Fluvirin. It was not reported whether or not the vaccinee had experienced any adverse events at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/01/2003	12/01/2003	0		UNK	UNK	NONE		NONE		PJP200301279	1						1	Medication error	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0230731	12/10/2004		3.0	2	.9	M	10/08/2004	A report was received from a health care professional concerning a 3 year old male vaccinee who was inadvertently administered Fluvirin on 12/8/03. On 12/8/03, the vaccinee was inadvertently administered Fluvirin. No adverse events have occurred as a result at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1/27/04: A follow up report from a health care professional confirmed that the vaccinee did not experience any adverse events. No follow up pending. All information received.									U	12/08/2003	12/08/2003	0		UNK	UNK	NONE		NONE		PJP200301280	1						1	Medication error	FLU3~EVANS VACCINES~765971~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230732	12/10/2004					U	10/08/2004	A report was received from a health care professional on 12/10/03 concerning an unknown number of patients aged less than 4 years of age and of unknown gender who inadvertently received Fluvirin on an unknown date. On an unknown date, an unknown number of patients aged less than 4 years of age and of unknown gender inadvertently received Fluvirin. No adverse events have occurred as a result at the time of the report. There was insufficient information to determine the reporter's causality assessment.									U					UNK	UNK	NONE		NONE		PJP200301281	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230733	12/10/2004		45.0	44		F	10/08/2004	A report was received from a health care professional on 12/10/03 concerning a 44 year old female vaccinee who experienced a sore, achy arm after receiving Fluvirin on 11/10/03 On 11/10/03, the vaccinee received Fluvirin vaccine. On 11/13/03 the vaccinee started to experience soreness in the area. On 12/10, she returned to the clinic and reported that her left arm continued to feel sore and achy. According to the reporter there was no nodules around the area but the patient had a global achiness in the area. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Follow up received 8/18/04 from health care professional. Letter received stating no further information regarding the vaccinee could be located.									U	11/10/2003	11/10/2003	0		UNK	UNK	NONE		NONE		PJP200301282	1						1	Injection site pain; Pain	FLU3~EVANS VACCINES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230734	12/10/2004					M	10/08/2004	A report was received from a health care professional 12/11/03 concerning a male vaccine in his 20's who experienced a burning sensation at the edges of his eye and a bad taste in his mouth on the same day as having Fluvirin inadvertently sprayed into his face on 12/11/03. On 12/11/03 a nurse drawing up the dose of Fluvirin accidentally sprayed his face and both eyes with vaccine. The nurse experienced a mild burning sensation at the edges of the eye and a bad taste in the mouth. He immediately flushed his face with copious amounts of water. At the time of the report, there were no residual symptoms other than a slight bad taste in his mouth. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/11/2003	12/11/2003	0		UNK	UNK	NONE		NONE		PJP200301283	1						1	Dysgeusia; Medication error; Thermal burn	FLU3~EVANS VACCINES~765754~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230735	12/10/2004		57.0	56		F	10/08/2004	A report was received from a consumer on 12/11/03 concerning a 56 year old female vaccinee who inadvertently received two doses of Fluvirin, one dose in the right arm and another in the left arm on 12/8/03. On 12/8/03, the vaccinee inadvertently received two doses of Fluvirin, one dose in the right arm and another in the left arm. At the time of the report, no adverse events had been reported. Follow up pending.									U	12/08/2003	12/08/2003	0		UNK	UNK	NONE		NONE		PJP200301284	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230736	12/10/2004		0.42	0	.4	M	10/08/2004	A report was received from a health care professional on 12/11/03 concerning approximately six children aged between 1 and 3.5 years and of unspecified sex who inadvertently received Fluvirin from an unspecified date in October 2003 until 12/9/03. Approximately six children inadvertently received Fluvirin from an unspecified date in October 2003 until 12/9/03. At the time of the report, no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 2/16/04: Follow up information received from a health care professional indicated that a 1.5 year old male vaccinee inadvertently received Fluvirin on 12/7/03. No adverse events have been reported to date. No follow up pending.									U	12/07/2003	12/07/2003	0		UNK	UNK	NONE		NONE		PJP200301285	1						1	Medication error	FLU3~EVANS VACCINES~766053~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230737	12/10/2004					U	10/08/2004	A report was received from a health care professional on 12/11/03 concerning approximately 10 children between the ages of 6 months and 3 years who inadvertently received Fluvirin between the dates of 12/8/03 and 12/10/03. Between the dates of 12/8/03 and 12/10/03, approximately 10 children inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/08/2003	12/08/2003	0		UNK	UNK	NONE		NONE		PJP200301286	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230738	12/10/2004		2.0			F	10/08/2004	A report was received from a health care professional on 12/11/03 concerning a 2 year old female vaccinee who inadvertently received Fluvirin on an unknown date. On an unknown date the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200301287	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230739	12/10/2004		65.0	64		F	10/08/2004	A report was received from a health care professional on 12/11/03 concerning a female vaccinee of unknown age who experienced swelling, redness and warmth on the arm and shoulder on the same day or the day after receiving Fluvirin on 12/5/03. On 12/5 or 12/6/03 the vaccinee complained of local reactions with swelling, redness, and warmth on the arm and shoulder. The symptoms had resolved on an unspecified date. There was insufficient information to determine the reporter's causality assessment. Update 3/9/04: Follow up information received from a health care professional indicated that at the time of the event the vaccinee was 64 years of age. On 12/5/03 the patient also developed a rash without erythema approximately the size of a silver dollar. The rash resolved on an unspecified date. The reporter has clarified the causality assessment of the swelling and rash to Fluvirin as probable. No follow up pending, all information received.									U	12/05/2003	12/05/2003	0		UNK	UNK	NONE		Hypersensitivity to mercury; High cholesterol; Breast Cancer		PJP200301288	1						1	Injection site erythema; Injection site swelling; Injection site warmth; Rash	FLU3~EVANS VACCINES~766053~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230740	12/10/2004					U	10/08/2004	A report was received from a health care professional on 12/11/03 concerning approximately 10 children of unknown sex and less than 4 years of age who inadvertently received Fluvirin between 12/8/03 and 12/11/03. Between 12/8/03 and 12/11/03, approximately 10 children inadvertently received Fluvirin. At the time of the report, no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/08/2003	12/08/2003	0		UNK	UNK	NONE		NONE		PJP200301289	1						1	Medication error	FLU3~EVANS VACCINES~765486~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230741	12/10/2004		9.0	8		M	10/08/2004	A report was received from a consumer on 12/10/03 concerning a 9 year old male vaccinee who received Fluvirin on 10/11/03 and developed hives and a huge rash all over his body. On 10/11/03 the vaccinee received Fluvirin and developed hives and a huge rash all over his body. The patient was treated with diphenhydramine. The vaccinee recovered from the rash on 10/14/03. Update 2/10/04: Further information was received from a health care professional on 2/10/04 indicating that the vaccinee was administered Fluvirin at church and the on call doctor was contacted regarding the vaccinees rash. The vaccinee was seen in the office on 10/30/03. There was insufficient information to determine the reporter's causality assessment. No follow up pending, all information received.									U	10/11/2003	10/11/2003	0		UNK	UNK	NONE		NONE		PJP200301290	1						1	Rash; Urticaria	FLU3~EVANS VACCINES~765196~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230742	12/10/2004					U	10/08/2004	A report was received from a health care professional on 12/11/03 concerning 2 or 3 vaccinees of unknown sex and less than 4 years of age who inadvertently received Fluvirin on 12/8/03. On 12/8/03, 2 or 3 vaccinees inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/08/2003	12/08/2003	0		UNK	UNK	NONE		NONE		PJP200301291	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230743	12/10/2004		71.0	71		M	10/08/2004	A report was received from a health care professional on 12/11/03 concerning a male vaccinee in his 50's who inadvertently received 1ml of Fluvirin on the same day. On 12/11/03 a vaccinee inadvertently received 1ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 2/10/04: A follow up report was received from a health care professional indicating that the 71 year old vaccinee had not experienced any adverse events at the time of reporting. No follow up pending. All information received.									U	12/11/2003	12/11/2003	0		UNK	UNK	Coumadin; Clonidine		NONE		PJP200301292	1						1	Medication error	FLU3~EVANS VACCINES~765947~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230744	12/10/2004		3.0			F	10/08/2004	A report was received from a health care professional on 12/11/03 concerning a 3 year old female vaccinee who inadvertently received Fluvirin on an unknown date in November 2003. On an unknown date in November 2003, the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/01/2003	11/01/2003	0		UNK	UNK	NONE		NONE		PJP200301293	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230745	12/10/2004		1.5			M	10/08/2004	A report was received from a health care professional on 12/11/03 concerning an 18 month old vaccinee of unknown demography who inadvertently received 0.25ml Fluvirin vaccine on 12/10/03. On 12/10/03, the vaccinee received Fluvirin vaccine. No adverse events were reported. There was insufficient information to determine the reporter's causality assessment. Update 3/15/04: Further information was received from a health care professional indicating that the vaccinee was male and inadvertently received Fluvirin SC on 12/10/03. No adverse events were reported at the time of the report. Follow up pending.									U	12/10/2003	12/10/2003	0		UNK	UNK	NONE		NONE		PJP200301294	1						1	Medication error	FLU3~EVANS VACCINES~766051~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230746	12/10/2004		3.0			F	10/08/2004	A report was received from a health care professional on 12/11/03 concerning an 3.5 year old vaccinee of unknown gender who inadvertently received 0.5ml Fluvirin vaccine on 12/10/03. On 12/10/03, the vaccinee received Fluvirin vaccine. No adverse events were reported. There was insufficient information to determine the reporter's causality assessment. Update 3/15/04: Further information was received from a health care professional indicating that the vaccinee was female and inadvertently received Fluvirin SC on 12/10/03. No adverse events were reported at the time of the report. Follow up pending.									U	12/10/2003	12/10/2003	0		UNK	UNK	NONE		NONE		PJP200301295	1						1	Medication error	FLU3~EVANS VACCINES~766051~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230747	12/10/2004		1.79	1	.8	M	10/08/2004	A report was received from a health care professional on 12/11/03 concerning a 21 month old male vaccinee who inadvertently received 0.25ml Fluvirin vaccine on 12/09/03. On 12/9/03 the vaccinee received Fluvirin vaccine. No signs or symptoms of an adverse event were reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/09/2003	12/09/2003	0		UNK	UNK	NONE		NONE		PJP200301296	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230748	12/10/2004		3.0	2	.5	F	10/08/2004	A report was received from a health care professional on 12/11/03 concerning a 2 year old female vaccinee who inadvertently received 0.25ml Fluvirin vaccine on 12/09/03. On 12/9/03 the vaccinee received Fluvirin. No signs or symptoms of an adverse event were reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/09/2003	12/09/2003	0		UNK	UNK	NONE		NONE		PJP200301297	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230749	12/10/2004		36.0			F	10/08/2004	A report was received from a 36 year old female health professional who experienced fever, sore throat, cough and tingling at the injection site following receipt of Fluvirin on 12/8/03. On 12/8/03, the vaccinee who is also the reporter, received Fluvirin. On 12/10/03 the vaccinee experienced fever with a temperature for approximately 99F. On 12/11/03 the vaccinees temperature increased to 100.5F and she developed a sore throat, cough and tingling at the injection site. The events resolved on 12/13/03. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/08/2003	12/08/2003	0		UNK	UNK	NONE		NONE		PJP200301299	1						1	Cough; Paraesthesia; Pharyngolaryngeal pain; Pyrexia	FLU3~EVANS VACCINES~765873~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230750	12/10/2004		2.0			F	10/08/2004	A report was received from a health care professional on 12/12/03 concerning a 2 year old female vaccinee who was inadvertently administered Fluvirin on an unknown date. On an unknown date, a vaccinee was inadvertently administered Fluvirin. No adverse events had occurred as a result of this, at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 1/26/04: A follow up report received from a health care professional confirmed that the vaccinee received Fluvirin on 12/5/03. No follow up information pending.									U	12/05/2003	12/05/2003	0		UNK	UNK	NONE		NONE		PJP200301300	1						1	Medication error	FLU3~EVANS VACCINES~765664~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230751	12/10/2004		3.0			M	10/08/2004	A report was received from a health care professional on 12/12/03 concerning a 3 year old male vaccinee who was inadvertently administered Fluvirin on an unknown date. On an unknown date, a vaccinee was inadvertently administered Fluvirin. No adverse events had occurred as a result of this at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 1/26/04: A follow up report received from a health care professional confirmed that the vaccinee received Fluvirin on 12/9/03. No follow up pending.									U	12/09/2003	12/09/2003	0		UNK	UNK	NONE		NONE		PJP200301301	1						1	Medication error	FLU3~EVANS VACCINES~765664~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230752	12/10/2004		1.25			M	10/08/2004	A report was received from a health care professional on 12/12/03 concerning a 15 month old male vaccinee who inadvertently received Fluvirin on 12/10/03. On 12/10/03, the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/10/2003	12/10/2003	0		UNK	UNK	NONE		NONE		PJP200301302	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230753	12/10/2004		3.0			U	10/08/2004	A report was received from a health care professional on 12/12/03 concerning a 3 year old vaccine of unspecified sex who inadvertently received Fluvirin on an unknown date. On an unknown date, the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200301303	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230754	12/10/2004		52.0			F	10/08/2004	A report was received from a health care professional on 12/12/03 concerning a 52 year old female vaccinee who inadvertently received 1ml of Fluvirin on the same day. On 12/12/03, a vaccinee inadvertently received 1ml of Fluvirin. At the time of the report, no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/12/2003	12/12/2003	0		UNK	UNK	NONE		NONE		PJP200301304	1						1	Medication error	FLU3~EVANS VACCINES~765875~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230755	12/10/2004					U	10/08/2004	A report was received from a health care professional on 12/12/03 concerning approximately 25 vaccinees of unknown sex and aged between 6 and 35 months who inadvertently received Fluvirin over a 3 week period in November 2003. Approximately 25 vaccinees inadvertently received Fluvirin over a 3 week period in November 2003. At the time of the report no adverse events had been reported. There was insufficient to determine the reporter's causality assessment. Follow up pending.									U	11/01/2003	11/01/2003	0		UNK	UNK	NONE		NONE		PJP200301305	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230756	12/10/2004					U	10/08/2004	A report was received from a health care professional on 12/12/03 concerning 14 vaccinees of unknown sex and less than 4 years of age who inadvertently received Fluvirin on the same day. On 12/12/03, 14 vaccinees inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/12/2003	12/12/2003	0		UNK	UNK	NONE		NONE		PJP200301306	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230757	12/10/2004		4.0	3		M	10/08/2004	A report was received from a health care professional on 12/12/03 concerning two vaccinees of unknown sex and aged between 2 and 3 years who inadvertently received Fluvirin on the same day. On 12/12/03, two vaccinees inadvertently received Fluvirin. At the time of the report no adverse events had been reports. There was insufficient information to determine the reporter's causality assessment. Update 3/1/04: Follow up information received from a health care professional indicated that a 3.5 year old male vaccine inadvertently received Fluvirin on 12/12/03. No adverse events have been reported to date. No follow up pending, all information received.									U	12/12/2003	12/12/2003	0		UNK	UNK	NONE		NONE		PJP200301307	1						1	Medication error	FLU3~EVANS VACCINES~766049~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230758	12/10/2004					U	10/08/2004	A report was received from a health care professional on 12/12/03 concerning an unknown number of children of unspecified sex and less than 4 years of age who inadvertently received Fluvirin on an unknown date. On an unknown date, an unspecified number of vaccinees inadvertently received Fluvirin. At the time of the event no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 2/23/04: Follow up information received from a health care professional indicated that 31 children aged between 7 months and 3.5 years inadvertently received 0.25ml or 0.50ml Fluvirin between 12/10/03 and 12/12/03. No adverse events were reported. No follow up pending.									U	12/10/2003	12/10/2003	0		UNK	UNK	NONE		NONE		PJP200301308	1						1	Medication error	FLU3~EVANS VACCINES~765483~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230759	12/10/2004		3.0			U	10/08/2004	A report was received from a health care professional on 12/12/03 concerning a 3 year old vaccinee of unknown sex who inadvertently received Fluvirin on an unknown date. On an unknown date the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200301309	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230760	12/10/2004		3.0			M	10/08/2004	A report was received from a health care professional on 12/12/03 concerning a 3 year old male vaccinee who inadvertently received Fluvirin on 12/11/03. On 12/11/03 the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/11/2003	12/11/2003	0		UNK	UNK	NONE		NONE		PJP200301310	1						1	Medication error	FLU3~EVANS VACCINES~765712~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230761	12/10/2004		7.0			U	10/08/2004	A report was received from a health care professional on 10/29/03 concerned a 7 year old vaccinee of unknown sex who received a sub-optimal dose of Fluvirin on 10/25/03. On 10/25/03, the vaccinee received a 0.25ml Fluvirin instead of 0.5ml. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/25/2003	10/25/2003	0		UNK	UNK	NONE		NONE		PJP200301311	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230762	12/10/2004		4.0	4		F	10/08/2004	A report was received from a consumer on 12/15/03 concerning a 4 year old female vaccinee who inadvertently received a sub-optimal dose of Fluvirin in the buttocks on 12/12/03. On 12/12/03, the vaccinee inadvertently received 0.25ml Fluvirin in the buttocks. At the time of the report no adverse events had been reported. There was insufficient information to determine  the reporter's causality assessment. Follow up pending.									U	12/12/2003	12/12/2003	0		UNK	UNK	NONE		NONE		PJP200301312	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230763	12/10/2004		1.26	1	.3	M	10/08/2004	A report was received from a health care professional on 12/15/03 concerning a 15 month old male vaccinee who inadvertently received two doses of Fluvirin on an unknown date in 2003. On an unknown date in 2003 the vaccinee inadvertently received two doses of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/22/2003	10/22/2003	0		UNK	UNK	NONE		NONE		PJP200301313	1						1	Medication error	FLU3~EVANS VACCINES~766054~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230764	12/10/2004		1.4	1	.4	M	10/08/2004	A report was received from a health care professional on 12/15/03 concerning a 1 year old male vaccinee who inadvertently received Fluvirin on the same day. On 12/15/03 the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/15/2003	12/15/2003	0		UNK	UNK	NONE		NONE		PJP200301315	1						1	Medication error	FLU3~EVANS VACCINES~765952~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230765	12/10/2004		2.0			F	10/08/2004	A report was received from a health care professional on 12/15/03 concerning a 2 year old female vaccinee who inadvertently received Fluvirin vaccine on 12/13/03. On 12/13/03, the vaccinee was administered Fluvirin. The vaccinee did not experience any adverse events at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 2/23/04: Further information was received from a health care professional indicating that the mother of the vaccinee stated that the vaccinee had no adverse reaction or side effects. No follow up pending. All information received.									U					UNK	UNK	NONE		NONE		PJP200301316	1						1	Medication error	FLU3~EVANS VACCINES~766054~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230766	12/10/2004		1.5			M	10/08/2004	A report was received from a health care professional on 12/15/03 concerning an 18 month old male vaccinee who inadvertently received Fluvirin vaccine on an unspecified day in October 2003. On an unspecified day in October 2003 the vaccinee was administered Fluvirin. No adverse events were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/01/2003	10/01/2003	0		UNK	UNK	NONE		NONE		PJP200301317	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230767	12/10/2004		61.0			F	10/08/2004	A report was received from health care professional on 10/22/03 concerning a 61 year old female vaccinee who developed a protruding, ping pong ball sized swelling immediately after receiving Fluvirin vaccine on 10/8/03. On 10/8/03, the vaccinee developed a protruding, ping pong ball-sized swelling immediately after receiving Fluvirin vaccine. The reporter stated that the adverse event is most likely resolved. There was insufficient information to determine the reporter's causality assessment. Update 12/16/03: The egg sized swelling at the injection site resolved 4-5 days after onset. Follow up pending.									U	11/12/2003	11/12/2003	0		UNK	UNK	NONE		NONE		PJP200301318	1						1	Injection site swelling	FLU3~EVANS VACCINES~765664~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230768	12/10/2004		2.0	2	.1	F	10/08/2004	A report was received from a consumer on 12/16/03 concerning a 2 year old female vaccinee who experienced fever between 101-102 degrees F which persisted for 3 to 4 days after vaccination and a fever of 99.6 degrees F on 12/15/03 after inadvertently receiving Fluvirin vaccine on 12/3/03. On 12/3/03 the vaccinee was inadvertently administered Fluvirin. The vaccinee experienced a fever between 101-102 degrees F which lasted for 3 to 4 days following vaccine administration. On 12/15/03 the vaccinee experienced a fever of 99.6 degrees F. It was unknown at the time of the report if the fever which started on 12/15/03 still persists. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/03/2003	12/03/2003	0		UNK	UNK	NONE		NONE		PJP200301319	1						1	Medication error; Pyrexia	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230769	12/10/2004					U	10/08/2004	A report was received from a health care professional on 12/16/03 concerning 42 vaccinees, both males and females under 4 years of age who inadvertently received Fluvirin on unspecified dates in December 2003. On unspecified dates in December 2003 the vaccinees inadvertently received Fluvirin. It was unknown by the reporter if the vaccinees experienced any adverse symptoms at the time of the reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/01/2003	12/01/2003	0		UNK	UNK	NONE		NONE		PJP200301320	1						1	Medication error	FLU3~EVANS VACCINES~766052~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230770	12/10/2004		1.59	1	.6	M	10/08/2004	A report was received from a health care professional on 12/16/03 concerning a group of 5 vaccinees aged less than 4 years of age and of unknown gender who were inadvertently administered Fluvirin on an unknown date. On an unknown date, a group of 5 vaccinees aged less than 4 years of age and of unknown gender were inadvertently administered Fluvirin. No adverse events have occurred as a result of this at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/26/04: A follow up report was received from a health care professional indicating that a 1 year old male vaccinee experienced symptoms of fever and cough 2 months after inadvertently receiving 0.25ml Fluvirin on 11/24/03. The vaccinee recovered after approximately 7 days. On an unspecified date, the vaccinee tested negative for influenza A and influenza B. Follow up pending.									U	11/24/2003	11/24/2003	0		UNK	UNK	NONE		NONE		PJP200301321	1						1	Cough; Medication error; Pyrexia	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230771	12/10/2004		4.0	3		M	10/08/2004	A report was received from a health care professional on 12/16/03 concerning a vaccinee aged less than 4 years of age and of unknown gender who was inadvertently administered Fluvirin and experienced fever on an unknown date. On an unknown date, the vaccinee was inadvertently administered Fluvirin and experienced fever. There is no information available on the outcome of this event. There was insufficient information to determine the reporter's causality assessment. Update 3/26/04: A follow up report was received from a health care professional indicating that a 3 year old male vaccinee experienced symptoms of upper respiratory tract infection, fever, and cough 2 months after inadvertently receiving 0.5ml Fluvirin on 11/24/03. The vaccinee recovered after 7 days. On 1/20/04, the vaccinee tested positive for influenza A and negative for influenza B. Follow up pending.									Y	11/24/2003	11/24/2003	0		UNK	UNK	NONE		NONE		PJP200301322	1						1	Cough; Medication error; Pyrexia; Upper respiratory tract infection	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230772	12/10/2004		1.5			M	10/08/2004	A report was received from a health care professional on 12/16/03 concerning an 18 month old male vaccinee who inadvertently received Fluvirin on an unknown date in December 2003. On an unknown date in December 2003, a vaccinee was inadvertently vaccinated with Fluvirin. No adverse events had occurred at the time of this report. There is insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/01/2003	12/01/2003	0		UNK	UNK	NONE		NONE		PJP200301323	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230773	12/10/2004		1.5			U	10/08/2004	A report was received from a health care professional on 12/16/03 concerning an 18 month old vaccinee of unknown gender who inadvertently received Fluvirin on an unknown date in December 2003. On an unknown date in December 2003 a vaccinee was inadvertently administered Fluvirin. No adverse events have occurred as a result of this, at the time of this report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/01/2003	12/01/2003	0		UNK	UNK	NONE		NONE		PJP200301324	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230774	12/10/2004		8.0			M	10/08/2004	A report was received from a health care professional on 12/17/03 concerning an 8 year old male vaccinee who inadvertently received a sub-optimal dose of Fluvirin on 12/15/03. On 12/15/03, a vaccinee inadvertently received a dose of 0.25ml of Fluvirin. No adverse events had occurred as a result at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/15/04: Further information was received from a health care professional indicating that the vaccinee did not experience any adverse reaction. The vaccinee did not contract influenza and he later received the full dosage of Fluvirin in mid-January. No follow up pending. All information received.									U	12/15/2003	12/15/2003	0		UNK	UNK	NONE		NONE		PJP200301325	1						1	Medication error	FLU3~EVANS VACCINES~765796~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230775	12/10/2004		49.0	49		F	10/08/2004	A report was received from a health care professional on 12/17/03 concerning a 49 year old female vaccinee who experienced a red, raised, painful area at the injection site within two hours of receiving Fluvirin on an unspecified date in October 2002. On an unspecified date in October 2002, the vaccinee experienced a red, raised, painful 5cm area at the injection site. The reaction resolved without medical intervention within 2 to 3 days. There was insufficient information to determine the reporter's causality assessment. Update 2/23/04: Further information received from a health care professional indicated that the vaccinee developed a round raised wheal 30 minutes following vaccination, which resolved 3 to 4 days later. The vaccinee did not have any previous exposure to Fluvirin. The reporter has assessed the relationship of the vaccination to the round raised wheal as probable. Follow up pending.									U	10/01/2002	10/01/2002	0		UNK	UNK	NONE		NONE		PJP200301326	1						1	Injection site erythema; Injection site pain; Injection site swelling; Urticaria	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230776	12/10/2004		4.0			F	10/08/2004	A report was received from a health care professional on 11/18/03 concerning a 4 year old vaccinee of unknown gender who inadvertently received a sub-optimal dose of Fluvirin on 11/11/03. On 11/11/03 the vaccinee received 0.25ml Fluvirin. The vaccinee did not exhibit any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1/19/04: A follow up report was received from a health care professional indicating that the vaccinee received a sub-optimal dose of Fluvirin on 11/10/03 approximately. No follow up pending. All information received.									U	11/10/2003	11/10/2003	0		UNK	UNK	NONE		NONE		PJP200301327	1						1	Medication error	FLU3~EVANS VACCINES~766055~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230777	12/10/2004		4.0	4		F	10/08/2004	A report was received from a health professional on 12/17/03 concerning a 4 year old female vaccinee who experienced swelling and redness that began at the back of her left hand and spread to her left forearm 3-4 hours after receiving Fluvirin vaccine on 12/16/03. On 12/16/03 the vaccinee experienced swelling and redness that started at the back of her left hand and spread to her left forearm. The vaccinee did not experience pruritus or pain. The swelling and redness of her left forearm resolved on 12/17/03. However, the vaccinee still complained of redness at the back of her hand. The vaccinee did not receive any treatments. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/16/2003	12/16/2003	0		UNK	UNK	NONE		NONE		PJP200301328	1						1	Erythema; Oedema peripheral	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230778	12/10/2004		1.8			F	10/08/2004	A report was received from a health care professional on 12/17/03 concerning a 22 month old female vaccinee who inadvertently received Fluvirin vaccine on 12/17/03. On 12/17/03 the vaccinee was administered 0.25ml Fluvirin. No adverse events were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/17/2003	12/17/2003	0		UNK	UNK	NONE		NONE		PJP200301329	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230779	12/10/2004		2.0			F	10/08/2004	A report was received from a health care professional on 12/17/03 concerning a 2.5 year old female vaccinee who inadvertently received Fluvirin vaccine on 12/17/03. On 12/17/03 the vaccinee was administered 0.5ml Fluvirin. The vaccinee had not exhibited any signs or symptoms of an adverse event at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/17/2003	12/17/2003	0		UNK	UNK	NONE		NONE		PJP200301330	1						1	Medication error	FLU3~EVANS VACCINES~766049~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230780	12/10/2004		79.0			F	10/08/2004	A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health care professional concerning a 79 year old female vaccinee who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccinee inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.									U	10/31/2003	10/31/2003	0		UNK	UNK	NONE		NONE		PJP200301332	1						1	Medication error	FLU3~EVANS VACCINES~765795~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230781	12/10/2004		86.0			F	10/08/2004	A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health care professional concerning an 86 year old female vaccinee who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccinee inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.									U	10/31/2003	10/31/2003	0		UNK	UNK	NONE		NONE		PJP200301333	1						1	Medication error	FLU3~EVANS VACCINES~765795~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230782	12/10/2004		93.0			F	10/08/2004	A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health care professional concerning a 93 year old female vaccinee who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccinee inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.									U	10/31/2003	10/31/2003	0		UNK	UNK	NONE		NONE		PJP200301334	1						1	Medication error	FLU3~EVANS VACCINES~765795~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230783	12/10/2004		78.0			F	10/08/2004	A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health care professional concerning a 78 year old female vaccinee who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccinee inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.									U	10/31/2003	10/31/2003	0		UNK	UNK	NONE		NONE		PJP200301335	1						1	Medication error	FLU3~EVANS VACCINES~765795~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230784	12/10/2004		96.0			F	10/08/2004	A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health care professional concerning a 96 year old female vaccinee who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccine inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.									U	10/31/2003	10/31/2003	0		UNK	UNK	NONE		NONE		PJP200301336	1						1	Medication error	FLU3~EVANS VACCINES~765795~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230785	12/10/2004		92.0			F	10/08/2004	A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health professional concerning a 92 year old female vaccine who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccinee inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.									U	10/31/2003	10/31/2003	0		UNK	UNK	NONE		NONE		PJP200301337	1						1	Medication error	FLU3~EVANS VACCINES~765795~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230786	12/10/2004		92.0			F	10/08/2004	A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccines received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health care professional concerning a 92 year old female vaccinee who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccinee inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.									U	10/31/2003	10/31/2003	0		UNK	UNK	NONE		NONE		PJP200301338	1						1	Medication error	FLU3~EVANS VACCINES~765795~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230787	12/10/2004		82.0			M	10/08/2004	A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health care professional concerning an 82 year old male vaccinee who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccinee inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.									U	10/31/2003	10/31/2003	0		UNK	UNK	NONE		NONE		PJP200301339	1						1	Medication error	FLU3~EVANS VACCINES~765795~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230788	12/10/2004		34.0			M	10/08/2004	A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health care professional concerning a 34 year old male vaccinee who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccinee inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.									U	10/31/2003	10/31/2003	0		UNK	UNK	NONE		NONE		PJP200301340	1						1	Medication error	FLU3~EVANS VACCINES~765795~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230789	12/10/2004		77.0			M	10/08/2004	A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health care professional concerning a 77 year old male vaccinee who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccinee inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.									U	10/31/2003	10/31/2003	0		UNK	UNK	NONE		NONE		PJP200301341	1						1	Medication error	FLU3~EVANS VACCINES~765795~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230790	12/10/2004		76.0			M	10/08/2004	A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health care professional concerning a 76 year old male vaccinee who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccinee inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.									U	10/31/2003	10/31/2003	0		UNK	UNK	NONE		NONE		PJP200301342	1						1	Medication error	FLU3~EVANS VACCINES~765795~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230791	12/10/2004		76.0			M	10/08/2004	A report was received from a health care professional on 11/10/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update reported was received from a health care professional concerning a 76 year old male vaccinee who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccinee inadvertently received Fluvirin SC. NO adverse symptoms were exhibited at the time of reporting. No follow up pending.									U	10/31/2003	10/31/2003	0		UNK	UNK	NONE		NONE		PJP200301343	1						1	Medication error	FLU3~EVANS VACCINES~765795~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230792	12/10/2004		36.0			M	10/08/2004	A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health care professional concerning a 36 year old male vaccinee who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccinee inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.									U	10/31/2003	10/31/2003	0		UNK	UNK	NONE		NONE		PJP200301344	1						1	Medication error	FLU3~EVANS VACCINES~765795~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230793	12/10/2004		100.0			F	10/08/2004	A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health care professional concerning a 100 year old female vaccinee who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccinee inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.									U	10/31/2003	10/31/2003	0		UNK	UNK	NONE		NONE		PJP200301345	1						1	Medication error	FLU3~EVANS VACCINES~765795~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230794	12/10/2004		5.0			F	10/08/2004	A report was received from a health care professional on 12/17/03 concerning a 5 year old female vaccinee who inadvertently received a sub-optimal dose of Fluvirin on 12/16/03. On 12/16/03, a vaccinee inadvertently received a dose of 0.25ml of Fluvirin. No adverse events had occurred as a result at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/15/04: Further information was received from a health care professional indicating that the vaccinee did not experience any adverse reaction. The vaccinee did not contract influenza and she later received the full dosage of Fluvirin in mid January. No follow up pending. All information received.									U	12/16/2003	12/16/2003	0		UNK	UNK	NONE		NONE		PJP200301346	1						1	Medication error	FLU3~EVANS VACCINES~765796~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230795	12/10/2004		6.0			M	10/08/2004	A report was received from a health care professional on 12/17/03 concerning a 6 year old male vaccinee who inadvertently received a sub-optimal dose of Fluvirin on 12/15/03. On 12/15/03, a vaccinee inadvertently received a dose of 0.25ml of Fluvirin. No adverse events had occurred as a result at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/15/04: Further information was received from a health care professional indicating that the vaccinee did not experience any adverse reaction. The vaccinee did not contract influenza and he later received the full dosage of Fluvirin in mid January. No follow up pending. All information received.									U	12/15/2003	12/15/2003	0		UNK	UNK	NONE		NONE		PJP200301347	1						1	Medication error	FLU3~EVANS VACCINES~765796~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230796	12/10/2004		6.0			F	10/08/2004	A report was received from a health care professional on 12/17/03 concerning a 6 year old female vaccinee who inadvertently received a sub-optimal dose of Fluvirin on 12/15/03. On 12/15/03, a vaccinee inadvertently received a dose of 0.25ml of Fluvirin. No adverse events had occurred as a result at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/15/04: Further information was received from a health care professional indicating that the vaccinee did not experience any adverse reaction. The vaccinee did not contract influenza and she later received the full dosage of Fluvirin in mid January. No follow up pending. All information received.									U	12/15/2003	12/15/2003	0		UNK	UNK	NONE		NONE		PJP200301348	1						1	Medication error	FLU3~EVANS VACCINES~765796~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230797	12/10/2004		6.0			M	10/08/2004	A report was received from a health care professional on 12/17/2003 concerning a 6 year old male vaccinee who inadvertently received a sub-optimal dose of Fluvirin on 12/15/03. On 12/15/03, a vaccinee inadvertently received a dose of 0.25ml of Fluvirin. No adverse events had occurred as a result at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/15/04: Further information was received from a health care professional indicating that the vaccinee did not experience any adverse reaction. The vaccinee did not contract influenza and he later received the full dosage of Fluvirin in mid January. No follow up pending. All information received.									U	12/15/2003	12/15/2003	0		UNK	UNK	NONE		NONE		PJP200301349	1						1	Medication error	FLU3~EVANS VACCINES~765796~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230798	12/10/2004		8.0			F	10/08/2004	A report was received from a health care professional on 12/17/03 concerning an 8 year old female vaccinee who inadvertently received a sub-optimal dose of Fluvirin on 12/15/03. On 12/15/03, a vaccinee inadvertently received a dose of 0.25ml of Fluvirin. No adverse events had occurred as a result at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/15/04: Further information was received from a health care professional indicating that the vaccinee did not experience any adverse reaction. The vaccinee did not contract influenza and she will later receive the full dosage of Fluvirin in mid January. No follow up pending. All information received.									U	12/15/2003	12/15/2003	0		UNK	UNK	NONE		NONE		PJP200301350	1						1	Medication error	FLU3~EVANS VACCINES~765796~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230799	12/10/2004		7.0			M	10/08/2004	A report was received from a health care professional on 12/17/03 concerning a 7 year old male vaccinee who inadvertently received a sub-optimal dose of Fluvirin on 12/15/03. On 12/15/03 a vaccinee inadvertently received a dose of 0.25ml of Fluvirin. No adverse events had occurred as a result at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/15/04: Further information was received from a health care professional indicating that the vaccinee did not experience any adverse reaction. The vaccinee did not contract influenza and he later received the full dosage of Fluvirin in mid January. No follow up pending. All information received.									U	12/15/2003	12/15/2003	0		UNK	UNK	NONE		NONE		PJP200301351	1						1	Medication error	FLU3~EVANS VACCINES~765796~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230800	12/10/2004		4.0	3		F	10/08/2004	A report was received from a consumer on 12/18/03 concerning a 3 year old female vaccinee who inadvertently received 0.5ml of Fluvirin in the thigh on 12/10/03. On 12/10/03, the vaccinee inadvertently received 0.5ml of Fluvirin in the thigh. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/10/2003	12/10/2003	0		UNK	UNK	NONE		NONE		PJP200301352	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230801	12/10/2004		1.0			F	10/08/2004	A report was received from a health care professional on 12/18/03 concerning a 1 year old female vaccinee who inadvertently received Fluvirin on 12/16/03. On 12/16/03 the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/16/2003	12/16/2003	0		UNK	UNK	NONE		NONE		PJP200301353	1						1	Medication error	FLU3~EVANS VACCINES~765853~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230802	12/10/2004					U	10/08/2004	A report was received from a health care professional on 12/18/03 concerning an unknown number of children, of unknown sex and less than 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date, an unknown umber of vaccinees inadvertently received Fluvirin. At the time of the report no adverse events have been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200301354	1						1	Medication error	FLU3~EVANS VACCINES~765756~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230803	12/10/2004					M	10/08/2004	A report was received from a health care professional on 12/18/03 concerning a mid-40 year old male vaccinee who developed a large hard, swollen and painful knot on the right thigh around the site of injection immediately after self-administration of Fluvirin on an unspecified date in November 2003. On an unspecified date in November 2003, the vaccinee self-administered Fluvirin into the right thigh. Immediately after administration, the vaccinee developed a large hard, swollen and painful knot around the area of administration that increased in size to 10 inches in diameter. The knot then slowly abated and disappeared in about a week. The same events happened with last year's vaccine but the knot was not as large. At the time of reporting, the vaccinee was not experiencing any symptoms. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/01/2003	11/01/2003	0		UNK	UNK	NONE		NONE		PJP200301355	1						1	Injection site induration; Injection site mass; Injection site pain; Injection site swelling	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230804	12/10/2004		42.0			F	10/08/2004	A report was received from a health care professional on 12/18/03 concerning a 42 year old female vaccinee who received expired Fluvirin on approximately 10/20/03. On approximately 10/20/03 the vaccinee received expired vaccine. The vaccinee did not experience any adverse effects as a result. There was insufficient information to determine the reporter's causality assessment. Update 2/16/04: A follow up report was received from a health care professional indicating that no adverse event had occurred at the time of reporting. No follow up pending. All information received.									U	10/01/2003	10/01/2003	0		UNK	UNK	NONE		NONE		PJP200301356	1						1	Medication error	FLU3~EVANS VACCINES~E10821LA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230805	12/10/2004		3.0			U	10/08/2004	A report was received from a health care professional on 12/19/03 concerning a 3 year old vaccinee of unknown gender who inadvertently received Fluvirin vaccine on an unspecified day in December 2003. On an unspecified day in December 2003, the vaccinee received Fluvirin. No adverse event was observed. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/01/2003	12/01/2003	0		UNK	UNK	NONE		NONE		PJP200301357	1						1	Medication error	FLU3~EVANS VACCINES~765799~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230806	12/10/2004		3.0			U	10/08/2004	A report was received from a health care professional on 12/19/03 concerning a 3.5 year old vaccinee of unknown gender who inadvertently received Fluvirin vaccine on an unspecified date in December 2003. On an unspecified date in December 2003, the vaccinee received Fluvirin. No adverse event was observed. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/01/2003	12/01/2003	0		UNK	UNK	NONE		NONE		PJP200301358	1						1	Medication error	FLU3~EVANS VACCINES~765799~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230807	12/10/2004		0.7			U	10/08/2004	A report was received from a health care professional on 12/19/03 concerning an 8 month old vaccinee of unknown gender who inadvertently received Fluvirin vaccine on an unspecified day in December 2003. On an unspecified day in December 2003, the vaccinee received Fluvirin. No adverse event was observed. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/01/2003	12/01/2003	0		UNK	UNK	NONE		NONE		PJP200301359	1						1	Medication error	FLU3~EVANS VACCINES~765799~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230808	12/10/2004					U	10/08/2004	A report was received from a health care professional on 12/19/03 concerning six children of unknown sex and less than 4 years of age who inadvertently received Fluvirin on an unspecified date in December 2003. On an unspecified date in December 2003, the vaccinees inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/01/2003	12/01/2003	0		UNK	UNK	NONE		NONE		PJP200301360	1						1	Medication error	FLU3~EVANS VACCINES~766054~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230809	12/10/2004					F	10/08/2004	A report was received from a health care professional on 12/23/03 concerning a female vaccinee in her forties who experienced a circular rash and swelling at the site of administration approximately 12 to 24 hours after receiving Fluvirin on 12/8/03. Approximately 12 to 24 hours after receiving Fluvirin on 12/8/036 the vaccinee experienced a red, raised circular rash with soreness or tenderness and slight swelling at the site of administration. The vaccinee was treated with 1% hydrocortisone topically and recovered 2-3 days later. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/08/2003	12/08/2003	0		UNK	UNK	Antibiotics		NONE		PJP200301363	1						1	Injection site erythema; Injection site pain; Injection site rash; Injection site swelling	FLU3~EVANS VACCINES~766055~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230810	12/10/2004					F	10/08/2004	A report was received from a health care professional on 12/23/03 concerning a female vaccinee in her forties who experienced a circular rash and swelling at the site of administration approximately 12 to 24 hours after receiving Fluvirin on 12/8/03. Approximately 12 to 24 hours after receiving Fluvirin on 12/8/03 the vaccinee experienced a red, raised circular rash with soreness or tenderness and slight swelling at the site of administration. The vaccinee was treated with 1% hydrocortisone topically and recovered 2-3 days later. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									Y	12/08/2003	12/09/2003	1		UNK	UNK	NONE		NONE		PJP200301364	1						1	Injection site erythema; Injection site pain; Injection site rash; Injection site swelling	FLU3~EVANS VACCINES~766055~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230811	12/10/2004					F	10/08/2004	A report was received from a health care professional on 12/23/03 concerning a female vaccine in her forties who experienced a circular rash and swelling at the site of administration approximately 12 to 24 hours after receiving Fluvirin on 12/20/03. Approximately 12 to 24 hours after receiving Fluvirin on 12/20/03 the vaccinee experienced a red, raised circular rash with soreness or tenderness and slight swelling at the site of administration. The vaccinee was treated with 1% hydrocortisone topically and recovered 2-3 days later. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									Y	12/20/2003	12/20/2003	0		UNK	UNK	NONE		NONE		PJP200301365	1						1	Injection site erythema; Injection site pain; Injection site rash; Injection site swelling	FLU3~EVANS VACCINES~766055~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230812	12/10/2004		1.0			M	10/08/2004	A report was received from a health care professional on 12/23/03 concerning a 1 year old male vaccinee who was inadvertently administered Fluvirin on 12/8/03. On 12/8/03, the vaccinee was inadvertently administered Fluvirin. No adverse events have occurred, as a result at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/08/2003	12/08/2003	0		UNK	UNK	NONE		NONE		PJP200301367	1						1	Medication error	FLU3~EVANS VACCINES~766051~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230813	12/10/2004		3.0			M	10/08/2004	A report was received from a health care professional on 12/23/03 concerning a 3 year old male vaccinee who was inadvertently administered Fluvirin on 12/18/03. On 12/18/03 the vaccinee was inadvertently administered Fluvirin. No adverse events have occurred as a result at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/18/2003	12/18/2003	0		UNK	UNK	NONE		NONE		PJP200301368	1						1	Medication error	FLU3~EVANS VACCINES~766051~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230814	12/10/2004		5.0			M	10/08/2004	A report was received from a health care professional on 12/23/03 concerning a 5 year old male vaccinee who was administered half of the correct dose of Fluvirin on 12/8/03. On 12/8/03, the vaccinee was administered 0.25ml of Fluvirin. No adverse events have occurred as a result at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/08/2003	12/08/2003	0		UNK	UNK	NONE		NONE		PJP200301369	1						1	Medication error	FLU3~EVANS VACCINES~766051~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230815	12/10/2004		0.9			M	10/08/2004	A report was received from a consumer on 12/23/03 concerning an 11 month old male vaccinee who inadvertently received Fluvirin on 12/8/03. On 12/8/03, the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/08/2003	12/08/2003	0		UNK	UNK	NONE		NONE		PJP200301370	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230816	12/10/2004					U	10/08/2004	A report was received from a health care professional on 12/30/03 concerning approximately 10 children of unspecified sex and under 4 years of age who inadvertently received Fluvirin on an unspecified date in December 2003. On an unspecified date in December 2003, approximately 10 children inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/01/2003	12/01/2003	0		UNK	UNK	NONE		NONE		PJP200301371	1						1	Medication error	FLU3~EVANS VACCINES~765138~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230817	12/10/2004		1.5			F	10/08/2004	A report was received from a health care professional on 1/2/04 concerning an 18 month old female vaccinee who inadvertently received Fluvirin vaccine on 12/2/03. On 12/2/03 the vaccinee received 0.25ml Fluvirin. No adverse events were reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/02/2003	12/02/2003	0		UNK	UNK	NONE		NONE		PJP200400001	1						1	Medication error	FLU3~EVANS VACCINES~765952~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230821	12/10/2004	NM	60.0	60		F	12/10/2004	Flu shot administered in left deltoid 10/28/2004. On 10/29/2004 had pain in right hip/SI joint. Pain worsened over next week.  Patient believes that flu shot activated inflammatory response.				Y					U	10/28/2004	10/29/2004	1	According to patient: Xray and MRI lumbar spine. Degenerative Disc Disease. No xrays of hip.	UNK	UNK	food supplements and vitamins	none noted	no allergies; GERD	swelling, pain~DT Adsorbed (no brand name)~1~0.00~In Patient		1						1	Arthralgia	FLU3~SANOFI PASTEUR~U1456AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0230822	12/10/2004	WA	34.0	34		F	12/10/2004	Within 3 hours of vaccination developed, fever, chills, apalling headache,total body ache and sore throat.  Lasted for about 3 days, still had sore throat and nasal congestion for about 10 days.									Y	10/15/2004	10/15/2004	0	None	UNK	UNK	NONE	NONE	NONE			1						1	Chills; Headache; Nasal congestion; Pain; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500335P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0230823	12/10/2004	CA	4.0	4		M	12/10/2004	PATIENT RECEIVED FLU VACCINE AND ABOUT 4 HOURS LATER BROKE OUT IN HIVES.  PATIENT CAME TO CLINIC.  PATIENT CONTACTED PRIVATE PROVIDER AND WAS ADVISED TO GIVE CHILD BENADRYL AND CONTACT OUR OFFICE TO COMPLETE VAERS.									Y	12/10/2004	12/10/2004	0		UNK	UNK	ESONEX PULMICORT		ASTHMA			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1553AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230840	12/10/2004	TN	51.0	51		M	12/05/2004	At approximately 1:30 PM my throat area between roof of mouth and collar bones began to tighten and construct and swallowing became difficult. Throat felt compressed. I drank water delayed eating till 7:00PM, Symptoms and headache disappeared about 6:30PM, belching was a serious problem.									Y	11/30/2004	11/30/2004	0	NONE	PUB	OTH	Metformin 500mg, Protonix 40mg, Diovan 100mg, Tamazepam 30mg		Diabetes, Blood pressure, GERD (Acid reflux), some insomnia.			1						1	Dysphagia; Eructation; Headache; Throat tightness	FLU3~SANOFI PASTEUR~U1559BA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230841	12/10/2004	OR	1.25	1	.3	M	12/01/2004	Developed fever about 4 hrs after shot, temp to 104.3 by 23:00. Also developed runny nose, cough and very fussy. Poor appetite today, drinking less, 3 wet diapers today.									Y	11/30/2004	11/30/2004	0	NONE	PUB	PUB	Polyviflor 25 mg	NONE	NONE			1						1	Cough; Decreased appetite; Dehydration; Irritability; Pyrexia; Rhinorrhoea	DTAP~GLAXOSMITHKLINE BIOLOGICALS~630A2~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1469AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A74399E~3~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0283P~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0230842	12/10/2004	WI	28.0	27		M	11/08/2004	The day after being given the flu shot (11/4), he developed a papular rash approximately 3 long and 1.5 wide, next to the injection site. He reports no itching, burning, pain, warmth.									Y	11/04/2004	11/05/2004	1		UNK	PVT	Epivir, Ziagen, Visamune, MgO2, Prenatal Vitomin, Lutein, Atenolol, Potassium, Keppra, KCl, Hydrocortisone	Nothing acute	AIDS, History cryptococcal meningitis.			1						1	Feeling hot; Injection site rash; Pain; Pruritus; Rash papular; Skin burning sensation	FLU3~SANOFI PASTEUR~U1446AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230843	12/10/2004	PA	0.54	0	.5	M	12/05/2004	Hives all over body: given Benadryl and Orapred				Y					Y	12/03/2004	12/03/2004	0		PVT	PUB		Upper respiratory infection	Bronchiolitis Per follow up report received on 01/21/2005: allergy to egg.			1						1	Urticaria	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~21A00844~3~~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1489AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A57561H~3~~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0230844	12/10/2004	KS	41.0			F	11/15/2004	Had received a flu shot and 24 hour later the area around the site was red, hard, warm and very sore. It kept getting larger and pretty much involved the whole upper arm. There was a small blister in the center of reddened area.									U	11/08/2004	11/09/2004	1		UNK	UNK	Keflex 500 mg PO TID x 5 days					1						1	Blister; Injection site erythema; Injection site induration; Injection site pain; Injection site vesicles; Injection site warmth	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230845	12/10/2004	NM	1.3	1	.3	F	12/01/2004	Fussy after shots, took a nap. Parent woke child to go out to eat while driving, child was fussy, then suddenly stopped. Mom looked at child: acted like she fell asleep, but her face looked funny. Mom shook child 20-30 sec and woke her. Fussy again. Ate a little , but mom still worried. Called doctor and was advised to go to ER. Child acted okay while there, lab and EKG were WNL. Advised to watch child and report any worries.				Y					Y	11/30/2004	11/30/2004	0	EKG, WNL, Blood tests: WNL	PVT	PUB						1						1	Irritability; Somnolence	DTAP~GLAXOSMITHKLINE BIOLOGICALS~639B2~4~~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1390AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0230846	12/10/2004	KS	45.0	45		M	12/03/2004	By mid noon 12hrs low grade temp, chills, 32 hours, 102 temp, chills, malaise, high temp for 3 days, respiratory symptoms began within 24 hours, sniffles, irritable throat. 72 hours began Zithromax for diagnosed pneumonia.				Y					U	11/22/2004	11/23/2004	1	CXR, Lung congestion, pneumonia, ENT exam : irritation	PVT	PVT						1						1	Chills; Laboratory test abnormal; Malaise; Pneumonia; Pyrexia; Rhinorrhoea; Upper respiratory tract infection	FLUN3~MEDIMMUNE VACCINES, INC.~500352P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0230847	12/10/2004	AL	69.0	68		M	12/04/2004	Approximately 6 hours after vaccination: felt dizzy and tightness in chest very difficult breathing and a low fever. Took Tylenol pm, next day seemed okay.									Y	11/17/2004	11/17/2004	0		PUB	PUB	Coreg, Coumadin, Zocor, ASA		Mitral valve replacement			1						1	Chest discomfort; Dizziness; Dyspnoea; Pyrexia	FLU3~SANOFI PASTEUR~U1531AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230848	12/10/2004	MN	0.58	0	.6	F	12/10/2004	Generalized urticaria but no dyspnea: Benadryl prescribed				Y					U	12/09/2004	12/10/2004	1		PVT	PVT	Tylenol	Mild URI				1						1	Urticaria	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~21A008AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1469AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A57561E~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0230849	12/10/2004	NY	2.0	2	.0	M	12/04/2004	Left thigh swollen, pink, hot to touch, not tender. Advised use of cold pack,Benadryl if itchy or uncomfortable , return if pain or fever. DTaP only vax in left thigh.									U	11/17/2004	11/19/2004	2		PVT	PVT	PPD Shot		asthma			1						1	Feeling hot; Injection site reaction; Skin discolouration; Swelling	DTAP~PFIZER\WYETH~A614C9~2~IM~LL~DTAP (ACEL-IMUNE)~1|FLUX~UNKNOWN MANUFACTURER~U1516AA~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~SMITHKLINE BEECHAM~816A2~1~IM~~HEP A (HAVRIX)~1	USA		Influenza
0230850	12/10/2004	NY	1.19	1	.2	F	12/10/2004	10/30: Pt seen by MD: left thigh hard, tender red lump around 2cm x 1.5cm, painful to touch. Advised hot soaks to leg vaccine site. Questionably infected. 10/31: Doctor spoke to mom. Still hard, red, tender. Advised to continue hot soaks and to recheck, would consider oral prescription (not yet). 11/5: mom called: still has lump, advised lump could stay x several months.									U	10/25/2004	10/30/2004	5		PVT	PVT						1						1	Infection; Injection site erythema; Injection site induration; Injection site mass; Injection site pain	FLU3~SANOFI PASTEUR~U1418A~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0075P~4~IM~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~1306N~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0439N~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0230824	12/11/2004	MI	74.0	74		F	12/11/2004	Had flu shot on wed. (Dec 1) and the next sat I was very sick, chills, tight cough, headache, muscle aches in my whole body. Two day had loose stools. It is a week later today a still not feeling better.									N	12/01/2004	12/04/2004	3	had none	UNK	UNK						1						1	Chills; Cough; Diarrhoea; Headache; Malaise; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0230825	12/11/2004	CA	24.0	23		F	12/11/2004	REDNESS AND SWELLING 40X35MM INDURATION.									Y	12/09/2004	12/10/2004	1		UNK	UNK						1						1	Injection site erythema; Injection site induration; Injection site swelling	FLU3~SANOFI PASTEUR~U1553AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230830	12/12/2004	CA	92.0	92		F	12/12/2004	Hoarseness the next day.  Lasting a few days.									Y	12/08/2004	12/09/2004	1		UNK	UNK	levothyroxine, pronestyl, warfarin, benazepril	None	A-Fib, High bld. Pressure,low thyroid,			1						1	Dysphonia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0230892	12/13/2004	MD	10.0	9		F	12/09/2004	Acute asthma attack on 12/03/04. Symptoms were shortness of breath, wheezing. Treated in ER : resp albuterol nebs and Solumedrol Visc. in 5 hours with oral Prednisone and albuterol MDI.				Y					Y	10/28/2004	12/03/2004	36	chest x ray normal	UNK	UNK			Asthma: diagnosed after ER visit.			1						1	Asthma; Condition aggravated; Dyspnoea; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500335P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0230893	12/13/2004	CA	45.0	45		F	12/06/2004	Right arm axilla swollen aching. Painful to pressure.									U	11/02/2004	11/02/2004	0		PUB	PVT		Diabetes	Diabetes, Goiter			1						1	Myalgia; Sensation of pressure; Swelling	FLU3~SANOFI PASTEUR~U1459AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230896	12/13/2004	WA	41.0	41		F	11/30/2004	Twitching of eyes, then began spreading out to other parts of body including arms, legs, abdomen, buttocks everywhere, felt cranky and more prominent on awaken in AM. Saw GP, eye doctor, neurologist and endocrinologist for thyroid and calcium studies. No numbness or tingling of extremities.									U	10/18/2004	11/08/2004	21	Thyroid study and calcium levels	PVT	PVT					WA042082	1						1	Irritability; Muscle twitching	FLU3~SANOFI PASTEUR~U1411AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230897	12/13/2004	WA	68.0	67		M	11/19/2004	Left arm swelling form elbow to hand. Called doctor's office and was told to take Aspirin elevate arm and use warm/moist heat.									Y	11/10/2004	11/16/2004	6		PUB	UNK					WA042081	1						1	Swelling	FLU3~SANOFI PASTEUR~01579AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~6863N~3~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0230898	12/13/2004	MI	37.0	36		F	11/05/2004	States left arm deltoid area was painful immediately after injection left arm at injection area became red and warm to touch immediately. On 11/3/04 approximately 1pm red rash developed on face and chest and then spread to abdomen back legs and arms. On 11/4 experienced extreme itching all over body. On 11/4 injection area left arm swollen red and warm to touch. ON 11/4 took Benedryl 50 mg at 11Am. By 5pm itching and rash redness improved. On 11/5 rash gone. Left deltoid area still red and warm to touch.									Y	11/03/2004	11/03/2004	0		PUB	PUB	Augmentin 900mg BID been on since 2000 bone infection, Celex 10 mg qd, calcium and vitamin c otc		Auto accident 5/2000 closed head injury. L+R hip replacements, artificial pelvis, Codavet bones both femurs 50% colon removed 60% liver removed, splenectomy, infection taking Augmentin since 6/2000			1						1	Erythema; Injection site erythema; Injection site warmth; Pruritus; Rash; Swelling	FLU3~SANOFI PASTEUR~U1489AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230899	12/13/2004	LA	73.0	72		F	12/02/2004	Complaints of pain after immunizations and then 12/01/04 pm noticed redness and swelling halfway around and down to elbow (8x14cm)									Y	11/30/2004	12/01/2004	1		PUB	PUB			Sulfa Drugs		LA041201	1						1	Erythema; Pain; Swelling	FLU3~SANOFI PASTEUR~U1531AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0685N~3~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0230900	12/13/2004	LA	73.0	72		F	12/01/2004	12/01/04: about 4-5 hours after influenza mom ran 100.5 degree temp with chills lasted about 24 hours. Also nausea and vomiting, dizzy, hives and itching in spots. 12/02/04: TC today much improved.									Y	11/30/2004	11/30/2004	0		PUB	PUB			Tetracycline		LA041207	1						1	Chills; Dizziness; Nausea; Pruritus; Pyrexia; Urticaria; Vomiting	FLU3~SANOFI PASTEUR~U1531AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230901	12/13/2004	ID	45.0	45		F	11/29/2004	On 11/11/04 patient called to report acute episode of bleeding in nose and gums which resolved without treatment. Over next 24-48 hours had fever 100.5 self treated with Tylenol and muscle aches/pain, chilling, nasal congestion and diarrhea x 3 episodes: Treated with Immodium. Symptoms resolved over 5 days.									Y	11/10/2004	11/11/2004	1		PUB	PVT					ID04057	1						1	Chills; Diarrhoea; Epistaxis; Gingival bleeding; Myalgia; Nasal congestion; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~5003337~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0230903	12/13/2004	ID	1.13	1	.1	F	11/10/2004	11/9/04: 2am awoke with fever of 101.7 ax and crying: fevers off and on all day. Temp increased to 104.9 at 3:30pm on 11/9: saw doctor within one hours. Home with antipyretic instructions. No other meds.				Y					Y	11/08/2004	11/09/2004	1		PVT	PUB					ID04054	1						1	Crying; Pyrexia	FLU3~SANOFI PASTEUR~U1392AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0230904	12/13/2004	IN				F	12/07/2004	Patient complained of right arm, knot formed, tender, pain radiating down arm and resp right side neck. Treated with Keflex 500 mg tid #30.				Y					U					PVT	UNK	Beneston, Diovan, Cerexa, Detrol LA, Multi-vitamin					1						1	Injection site mass; Neck pain; Pain; Tenderness	FLU3~SANOFI PASTEUR~U1531AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0230932	12/13/2004	SC	65.0	65		F	12/07/2004	Cellulitis near site on left hip.									Y	12/02/2004	12/04/2004	2		PVT	PVT	Zestoretic, Calan		Levaquin			1						1	Cellulitis	FLU3~SANOFI PASTEUR~U1552AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0278P~1~IM~LL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0230935	12/13/2004	VA	70.0	70		M	12/13/2004	Two hours after the vaccine shot on Dec. 10 at 3 PM I started to feel weak. Later on all classic flu symptoms developed: aching bones, weakness, running nose. No fever. Today is three days after the shot, I still feel poorly, no improvement. I was using Beconase spray to stop running nose, and tylenol to alleviate achiness. I have never had any flu shot reaction before.									U	10/12/2004	10/12/2004	0		UNK	UNK	antybiotics penicilline and amoxycilline after dental surgery a day before; plavix; aspirin; cozaar; hydrochlorothiazide	One day earlier was having dental surgery, before and after was given penicilline and amoxycilline	Allergy- rhinitis, asthma - cough			1						1	Asthenia; Influenza like illness; Malaise; Pain; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1411AA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230939	12/13/2004	CA	45.0	45		M	12/13/2004	10 day after the flu shot, I got the flu for about 2 weeks, it went away for about 3 days and returned. In december 1999 I had my first flu shot, I kept the flu off and on for 2 months.									U	11/04/2004	11/14/2004	10		UNK	UNK	metformin enalipril actos	no	diabetes high blood pressure high cholesterol	flu/cold~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Influenza like illness	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0230944	12/13/2004	NC	58.0	57		M	12/10/2004	11/17/2004: fever temp 100.4 degrees f; sore arm Tylenol given.									Y	11/16/2004	11/17/2004	1		MIL	PUB		Angina				1						1	Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~U1478AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0230945	12/13/2004	OH	9.0	8		M	12/13/2004	Mother states upper arm began swelling the evening after 8:45/am injection. Pt complained of pain at sight. Called MD 12/11/04 AM with complaints of redness and swelling of upper arm. Doctor ordered cold compresses and prednisone 15mg/5cc. Sig 1.75 tsp Laicy x 5 days. 12/12/04: mother took child to Er. No Prescription. 12/13/04: decreased swelling and redness.				Y					Y	12/10/2004	12/10/2004	0		PVT	PVT			Asthma when younger , Seasonal allergies			1						1	Erythema; Injection site pain; Swelling	FLU3~SANOFI PASTEUR~U1488AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0214681	12/14/2004		7.0	7		F	10/08/2004	A report was received from a health care professional on 01/06/04, concerning a 7 year old female vaccinee who experienced nausea, surface chest pain, pallor, weakness, fainting and developed a bruise and knot on her head resulting from the fall, 5 minutes after receiving Fluvirin on 01/05/04. The vaccinee had received influenza vaccine (Fluzone) one month prior to vaccination with Fluvirin as the first dose. On 01/05/4, within 5 minutes of receiving Fluvirin the vaccinee fainted, fell to the floor and became unresponsive but was breathing. Within 30 seconds the vaccinee was alert and oriented but appeared pale and weak. Her heart rate ranged from 108-128 beats per minute. As a result of falling to the floor the vaccinee hit her head, causing swelling and a bruise to her head. The vaccinee was observed from 40 minutes, during which time she drank fluids and at crackers. The vaccinee was then taken to an emergency department where  she was observed for one hour and then sent home. In the emergency department the vaccinee complained of nausea and superficial chest discomfort. The vaccinee's mother was contacted on 1/6/04 and she indicated that the vaccinee was doing well. the vaccinee slept well and was eating well. The vaccinee still complained of nausea and superficial chest pain. There was insufficient information to determine the reporter's causality assessment. Update 1 03/30/04: A follow up report was received from a health care professional indicating that the vaccinee fainted on 01/05/04. The vaccinee was taken to a hospital emergency room on 01/05/04 and was discharged on the same day. The reporter indicated that according to the vaccinee's parent, the vaccinee had previous exposure to Fluvirin and did not experience any adverse symptoms previously. the vaccinee was vaccinated prior to receiving Fluvirin on 12/5/03.				Y					U	01/05/2004	01/05/2004	0		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200400026	1						2	Asthenia; Fall; Oedema; Pallor; Syncope; Asthenia; Chest pain; Coma; Contusion; Fall; Heart rate increased; Nausea; Pallor; Syncope	FLU3~EVANS VACCINES~765878~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~EVANS VACCINES~765878~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0230947	12/14/2004		4.0	3		F	10/08/2004	A report was received from a health care professional on 05Jan03, concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 02Jan04. On 02Jan04 the vaccinee, who was less than 4 years of age, inadvertently received Fluvirin. The vaccinee had not experienced any signs or symptoms of an adverse event at the time of the report. There was insufficient information to determine the reporter's causality assessment. No follow up pending. Cross reference with: PJP200400003.									U	01/02/2004	01/02/2004	0		UNK	UNK	NONE		NONE		PJP200400002	1						1	Unevaluable event	FLU3~EVANS VACCINES~765947~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230948	12/14/2004		0.93	0	.9	M	10/08/2004	A report was received from a healthcare professional on 5 January 2003, concerning a 3 year old male vaccinee who inadvertently received Fluvirin on 2 January 2004. On 2 January 2004 the vaccinee, who was less than 4 years of age, inadvertently received Fluvirin.  The vaccinee had not experienced any signs or symptoms of an adverse event at the time of the report. There was insufficient information to determine the reporter's causality assessment. No follow up pending.									U	01/02/2004	01/02/2004	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200400003	1						1	Medication error	FLU3~EVANS VACCINES~765947~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230949	12/14/2004		3.0	2	.9	M	10/08/2004	A report was received from a healthcare professional on 03 December 2003, concerning a 2 year old male vaccinee who was inadvertently administered Fluvirin on 02 December 2003. On 02 December 2003, the vaccinee inadvertently received Fluvirin.  No adverse effects were reported at the time of report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/02/2003	12/02/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200400005	1						1	Medication error	FLU3~EVANS VACCINES~765756~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230950	12/14/2004		3.0	2	.5	M	10/08/2004	A report was received from a healthcare professional on 03 December 2003, concerning a 2 year old male vaccinee who was inadvertently administered Fluvirin on 02 December 2003. On 02 December 2003, the vaccinee inadvertently received Fluvirin.  No adverse effects were reported at the time of report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/02/2003	12/02/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200400006	1						1	Medication error	FLU3~EVANS VACCINES~765756~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230951	12/14/2004		0.97	0	1	F	10/08/2004	A report was received from a healthcare professional on 03 December 2003, concerning an 11 month old female vaccinee who was inadvertently administered Fluvirin on 02 December 2003. On 02 December 2003, the vaccinee inadvertently received Fluvirin.  No adverse effects were reported at the time of report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/02/2003	12/02/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200400007	1						1	Medication error	FLU3~EVANS VACCINES~765756~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230952	12/14/2004		4.0	3		M	10/08/2004	A report was received from a healthcare professional on 03 December 2003, concerning a 3 year old male vaccinee who was inadvertently administered Fluvirin on 02 December 2003. On 02 December 2003, the vaccinee inadvertently received Fluvirin.  No adverse effects were reported at the time of report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/02/2003	12/02/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200400008	1						1	Medication error	FLU3~EVANS VACCINES~765756~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230953	12/14/2004					F	12/02/2003	A report was received from a healthcare professional on 03 December 2003, concerning an 8 month old female vaccinee who was inadvertently administered Fluvirin on 02 December 2003. On 02 December 2003, the vaccinee inadvertently received Fluvirin.  No adverse effects were reported at the time of report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200400009	1						1	Medication error	FLU3~EVANS VACCINES~765756~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230954	12/14/2004		53.0	52		F	10/08/2004	A report was received from a healthcare professional on 15 October 2003 concerning a group of approximately 15 vaccinees who experienced injection site reaction, with redness, swelling and itching a few minutes after receiving Fluvirin on an unspecified date. On an unspecified date the vaccinees experienced injection site reactions with redness, swelling, and itching.  The vaccinees recovered on an unspecified date without treatment. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 22 December 2003. A follow up report was received from a healthcare professional concerning a 52 year old female vaccinee who experienced redness, swelling and moderate itching at the injection site on the same day as receiving Fluvirin on 10 October 2003. On 10 October 2003, the vaccinee experienced redness, swelling and moderate itching at the injection site after receiving Fluvirin 0.5ml.  The symptoms lasted for a duration of 2 hours, and had resolved at the time of follow up report. No follow up pending.									U	10/10/2003	10/10/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200400010	1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Pruritus	FLU3~EVANS VACCINES~765484~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230955	12/14/2004		83.0	83		F	10/08/2004	A report was received from a healthcare professional on 15 October 2003 concerning a group of approximately 15 vaccinees who experienced injection site reaction, with redness, swelling and itching a few minutes after receiving Fluvirin on an unspecified date. On an unspecified date the vaccinees experienced injection site reactions with redness, swelling, and itching.  The vaccinees recovered on an unspecified date without treatment. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 22 December 2003. A follow up report was received from a healthcare professional concerning an 83 year old female vaccinee who experienced redness, swelling and moderate itching at the injection site on the same day as receiving Fluvirin on 06 October 2003. On 06 October 2003, the vaccinee experienced redness, swelling and moderate itching at the injection site after receiving Fluvirin 0.5ml.  The symptoms had resolved at the time of follow up report. No follow up pending.									Y	10/06/2003	10/06/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200400011	1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Pruritus	FLU3~EVANS VACCINES~765484~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230956	12/14/2004		35.0	35		F	10/08/2004	A report was received from a healthcare professional on 15 October 2003 concerning a group of approximately 15 vaccinees who experienced injection site reaction, with redness, swelling and itching a few minutes after receiving Fluvirin on an unspecified date. On an unspecified date the vaccinees experienced injection site reactions with redness, swelling, and itching.  The vaccinees recovered on an unspecified date without treatment. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 22 December 2003. A follow up report was received from a healthcare professional concerning a 35 year old female vaccinee who experienced redness, swelling and severe itching at the injection site on the same day as receiving Fluvirin on 10 October 2003. On 10 October 2003, the vaccinee experienced redness, swelling and minor itching at the injection site after receiving Fluvirin 0.5ml.  The symptoms lasted for a duration of 30 minutes, and had resolved at the time of follow up report. No follow up pending.									Y	10/10/2003	10/10/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200400012	1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Pruritus	FLU3~EVANS VACCINES~765484~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230957	12/14/2004					M	10/08/2004	A report was received from a healthcare professional on 30 October 2003, concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date, an unspecified number of vaccinees under 4 years of age inadvertently received Fluvirin.  No adverse effects had occurred at the time of report. There was insufficient information to determine the reporter's causality assessment. Update 1, 01 December 2003. Follow up information received from a healthcare professional indicated that a 2 and a half year old male vaccinee inadvertently received Fluvirin on 18 October 2003 and had not experienced any adverse event at the time of the report. No follow up pending, all information received.									U	10/18/2003	10/18/2003	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200400013	1						1	Medication error	FLU3~EVANS VACCINES~765497~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230958	12/14/2004		1.5			F	10/08/2004	A report was received from a health care professional on 10/30/2003, concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on an unspecified date. No adverse effects had occurred at the time of report. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/01/03: Follow up information received from a health care professional indicated that an 18 month old female vaccinee inadvertently received Fluvirin on 10/18/03 and had no experienced any adverse event at the time of the report. No follow up pending, all information received. Cross reference with: PJP200300957, PJP200400013, PJP200400015, PJP200400016, PJP200400017, PJP200400018, PJP200400019, PJP200400020, PJP200400021, PJP200400022, PJP200400023 and PJP200400024.									U	10/18/2003				UNK	UNK	Concomitant Drug Not reported		No risk factors reported.		PJP200400014	1						1	Medication error	FLU3~EVANS VACCINES~765497~UNK~ID~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230959	12/14/2004		3.5			M	10/08/2004	A report was received from a health care professional on 10/30/2003, concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on an unspecified date. No adverse effects had occurred at the time of report. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/1/03: Follow up information received from a health care professional indicated that a 3 and a half year old male vaccinee inadvertently received Fluvirin on 10/18/03 and had not experienced any adverse event at the time of the report. No follow up pending, all information received. Cross reference with: PJP200300957, PJP200400013, PHP200400014, PJP200400016, PJP200400017, PJP200400018, PJP200400019, PJP200400020, PJP200400021, PJP200400022, PJP200400023, PJP200400024.									U	10/18/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported. Asthma		PJP200400015	1						1	Medication error	FLU3~EVANS VACCINES~765497~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230960	12/14/2004		1.1			M	10/08/2004	A report was received from a health care professional on 10/30/03, concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on an unspecified date. N adverse effects had occurred at the time of report. There was insufficient information to determine the reporter's causality assessment.  Update 1, 12/1/03: Follow up information received from a health care professional indicated that a 14 month old male vaccinee inadvertently received Fluvirin on 10/18/03 and had not experienced any adverse event at the time of the report. No follow up pending, all information received. Cross reference with: PJP200300957, PJP200400013, PJP200400014, PJP200400015, PJP200400017, PJP200400018, PJP200400019, PJP200400020, PJP200400021, PJP200400022, PJP200400023, PJP200400024.									U	10/18/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported. RAD		PJP200400016	1						1	Medication error	FLU3~EVANS VACCINES~765497~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230961	12/14/2004		0.75			F	10/08/2004	A report was received from a health care professional on 10/30/03, concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on an unspecified date. No adverse effects had occurred at the time of report. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/01/03: Follow up information received from a health care professional indicated that a 9 month old female vaccinee inadvertently received Fluvirin on 10/23/03 and had not experienced any adverse event at the time of report. No follow up pending, all information received. Cross reference with: PJP2003000957, PJP200400013, PJP200400014, PJP200400015, PJP200400016, PJP200400018, PJP200400019, PJP200400021, PJP200400022, PJP200400023, PJP200400024.									U	10/23/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200400017	1						1	Medication error	FLU3~EVANS VACCINES~765497~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230962	12/14/2004		0.58			M	10/08/2004	A report was received from a health care professional on 10/30/03, concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on an unspecified date. No adverse effects had occurred at the time of report. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/01/03: Follow up information received from a health care professional indicated that a 7 month old male vaccinee inadvertently received Fluvirin on 10/23/03 and had not experienced any adverse event at the time of the report. No follow up pending, all information received. Cross reference with: PJP200300957, PJP200400013, PJP200400014, PJP200400015, PJP200400016, PJP200400017, PJP200400019, PJP200400020, PJP200400021, PJP200400022, PJP200400023, PJP200400024.									U	10/23/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200400018	1						1	Medication error	FLU3~EVANS VACCINES~765497~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230963	12/14/2004		1.0			M	10/08/2004	A report was received from a health care professional on 10/30/03, concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on an unspecified date. No adverse effects had occurred at the time of report. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/01/03: Follow up information received from a health care professional indicated that a 13 month old male vaccinee inadvertently received Fluvirin on 10/23/03 and had not experienced any adverse event at the time of the report. No follow up pending, all information received. Cross reference with: PJP200300957, PJP200400013, PJP200400014, PJP200400015, PJP200400016, PJP200400017, PJP200400018, PJP200400020, PJP2004200021, PJP200400022, PJP200400023, PJP200400024.									U	10/23/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		pjp200400019	1						1	Medication error	FLU3~EVANS VACCINES~765497~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230964	12/14/2004		1.16			M	10/08/2004	A report was received from a health care professional on 10/30/03, concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on an unspecified date. No adverse effects had occurred at the time of report. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/01/03: Follow up information received from a health care professional indicated that a 14 month old male vaccinee inadvertently received Fluvirin on 10/23/03 and had not experienced any adverse event at the time of the report. No follow up pending, all information received. Cross reference with: PJP200300957, PJP200400013, PJP200400014, PJP200400015, PJP200400016, PJP200400017, PJP200400018, PJP200400019, PJP200400021, PJP200400022, PJP200400023, PJP200400024.									U	10/23/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported. Persistent ear infections		PJP200400020	1						1	Medication error	FLU3~EVANS VACCINES~765497~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230965	12/14/2004		0.75			M	10/08/2004	A report was received from a health care professional on 10/30/03, concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on an unspecified date. No adverse effects had occurred at the time of report. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/1/03: Follow up information received from a health care professional indicated that a 9 month old male vaccinee inadvertently received Fluvirin on 10/28/03 and had not experienced any adverse event at the time of the report. No follow up pending, all information received. Cross reference with: PJP200300957, PJP200400013, PJP200400014. PJP200400015, PJP200400016, PJP200400017, PJP200400018, PJP200400019, PJP200400020, PJP200400022, PJP200400023, PJP200400024.									U	10/28/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200400021	1						1	Medication error	FLU3~EVANS VACCINES~765497~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230966	12/14/2004		1.6			F	10/08/2004	A report was received from a health care professional on 10/30/03, concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on an unspecified date. No adverse effects had occurred at the time of report.  There was insufficient information to determine the reporter's causality assessment. Update 1, 12/01/03: Follow up information received from a health care professional indicated that a 20 month old female vaccinee inadvertently received Fluvirin on 10/24/03 and had not experienced any adverse event at the time of the report. No follow up pending, all information received.  Cross reference with: PJP200300957, PJP200400013, PJP200400014, PJP200400015, PJP200400016, PJP200400017, PJP200400018, PJP200400019, PJP200400020, PJP200400021, PJP200400023, PJP200400024.									U	10/24/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200400022	1						1	Medication error	FLU3~EVANS VACCINES~765497~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230967	12/14/2004		1.83			M	10/08/2004	A report was received from a health care professional on 10/30/03, concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on an unspecified date. No adverse effects had occurred at the time of report. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/01/03: Follow up information received from a health care professional indicated that a 22 month old male vaccinee inadvertently received Fluvirin on 10/11/03 and had not experienced any adverse event at the time of the report. No follow up pending, all information received. Cross reference with: PJP200300957, PJP200400013, PJP200400014, PJP200400015, PJP200400016, PJP200400017, PJP200400018, PJP200400019, PJP200400020, PJP200400021, PJP200400022, PJP200400024.									U	10/11/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200400023	1						1	Medication error	FLU3~EVANS VACCINES~765497~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230968	12/14/2004		1.33			F	10/08/2004	A report was received from a health care professional on 10/30/03, concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on an unspecified date. No adverse effects had occurred at the time of report. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/01/03: Follow up information received from a health care professional indicated that a 16 month old female vaccinee inadvertently received Fluvirin on 10/11/03 and had not experienced any adverse event at the time of the report. No follow up pending, all information received. Cross reference: PJP200300957, PJP200400013, PJP200400014, PJP200400015, PJP200400016, PJP200400017, PJP200400018, PJP20040019, PJP200400020, PJP200400021, PJP200400022, PJP200400023.									U	10/11/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200400024	1						1	Medication error	FLU3~EVANS VACCINES~765497~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230970	12/14/2004		51.0			M		A report was received from a consumer on 06Jan04 concerning a 51 year old male vaccinee who experienced a severe headache approx 2 hours following vaccination, shortness of breath, heaviness in his chest and tightening of his throat approx 5 to 6 hours following administration of Fluvirin vaccine on an unspecified day in December 2003. On an unspecified day in Dec 2003 the vaccinee was administered Fluvirin and approx 2 hours later, the vaccinee experienced a severe headache and approx 5 to 6 hours later, the vaccinee experienced shortness of breath, heaviness in his chest and tightening of his throat. The vaccinee attended the ER and was treated with nitroglycerin and his pain subsequently resolved. The vaccinee stated that his BCG and blood tests were within normal limits. The attending physician did not provide a diagnosis for the vaccinees symptoms. The outcome was not reported. The vaccinee was also evaluated by his primary care physician who stated that she did not think the pt's symptoms were related to the vaccine. Follow up pending.									U				Blood tests, EKG	UNK	UNK	NONE		NONE		PJP200400027	1						1	Chest pain; Dyspnoea; Headache; Pain; Throat tightness	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230971	12/14/2004		50.0			F	10/08/2004	A report was received from a health care professional on 24Oct03, concerning three female vaccinees of unk age who were inadvertently administered last years vaccine (2002-2003) on an unk date. On an unk date three female vaccinees were inadvertently administered last years vaccine (2002-2003). No adverse reactions had occurred at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1:10Dec03, Follow up report was received from a health care professional on 10Dec03 which indicated that a 50 year old female vaccinee inadvertently received 1ml of expired Fluvirin on 23Oct03. No adverse events were reported to date. Follow up pending. Cross referenced to PJP200300917 and PJP2003200400033.									U	10/23/2003	10/23/2003	0		UNK	UNK	NONE		NONE		PJP200400028	1						1	Unevaluable event	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230972	12/14/2004					U		A report was received from a health care professional on 06Jan04 concerning an adult vaccinee of unknown gender who inadvertently received two 0.5ml doses of Fluvirin vaccine, one dose on 23Dec03 and a second dose on 06Jan04. The vaccinee was inadvertently administered two doses of Fluvirin two weeks apart. The nurse who administered the vaccine was confused due to the 0.25ml marking on the Fluvirin pre-filled syringes and did not realize until after the second dose was administered that each pre-filled syringe contained 0.5ml. The vaccinee did not experience any adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/23/2003	01/06/2004	14		UNK	UNK	NONE		NONE		PJP200400032	1						1	Unevaluable event	FLU3~EVANS VACCINES~765746~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230973	12/14/2004		35.0			F	10/08/2004	Administration of expired product (Medication error, medication error)(Med error) - not reported Vaccinee received 1ml of vaccine (Accidental overdose, Accidental overdose)(Overdose accid) - not reported A report was received from a health care professional on 24 October 2003 concerning three female vaccinees of unknown age who were inadvertently administered last years' vaccine (2002-2003) on an unknown date. On an unknown date three female vaccinees were inadvertently administered last years' vaccine (2002-2003). No adverse reactions had occurred at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1: 10 December 2003 Follow-up report was received from a health care professional on 10 December 2003 which indicated that a 35 year old female vaccinee inadvertently received 1ml of expired Fluvirin on 23 October 2003. No adverse events were reported to date. Follow-up pending. Cross reference to PJP-2003-00917 and PJP-2003-00028.									U	10/23/2003	10/23/2003	0		UNK	UNK					PJP200400033	1						1	Accidental overdose; Medication error; Vaccination complication	FLU3~EVANS VACCINES~~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230974	12/14/2004		22.0			M	10/08/2004	Serum sickness (Serum sickness, Serum Sickness)(Serum Sick) - recovered/resolved Headache (Headache, Headache) - recovered/resolved Morbilliform Rash (Rash, Rash) - recovered/resolved Fever (Fever, Fever) - recovered/resolved Chills (Chills, Chills) - recovered/resolved Myalgia (Myalgia, Myalgia) - recovered/resolved Administration by unlicensed route (Medication error, Medication error)(Med Error) - not reported Administration of sub-optimal dose (Medication error, Medication error)(Med Error) - not reported A report was received from a health care professional on 07 January 2004 concerning a 22 year old male vaccinee who experienced serum sickness after inadvertently receiving 0.1ml of Fluvirin intradermally on 19 December 2003. On 19 December 2003 a vaccinee received 0.1ml of Fluvirin intradermally and approximately 24 December 2003 the vaccinee experienced a headache. On approximately 26 December 2003 the vaccinee experienced a morbilliform rash, fever, chills and myalgia which resolved on approximately 01 January 2004. The vacinee was diagnosed with serum sickness. On 30 December 2003 approximately, the vaccinee was treated with prednisone for two days which was then tapered  off over the next several days. The serum sickness resolved on an unspecified date. There was insufficient information to determine the reporter's causality assessment. Follow-up pending.									U	12/19/2003	12/19/2003	0		UNK	UNK					PJP200400034	1						1	Chills; Headache; Medication error; Myalgia; Pyrexia; Rash morbilliform; Serum sickness	FLU3~EVANS VACCINES~765980~2~ID~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230975	12/14/2004		1.51	1	.5	F	10/08/2004	Administration to a child under 4 years of age (Medication Error, Medication Error)(Med Error) - not reported. A report was received from a health care professional on 25 November 2003, concerning an 18 month old female vaccinee who advertently received Fluvirin on 07 November 2003.  On 07 November 2003 the vaccinee inadvertently received 0.25ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11 March 2004: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow-up pending, all information received.									U	11/07/2003	11/07/2003	0		UNK	UNK					PJP200400036	1						1	Medication error	FLU3~EVANS VACCINES~765952~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230976	12/14/2004		3.0	2	1	F	10/08/2004	Administration to a child under 4 years of age (Medication Error, Medication Error) (Med Error) - not reported  A report was received from a health care professional on 25 November 2003, concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 20 November 2003. On 20 November 2003 the vacinee inadvertently received 0.25ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11 March 2004: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow-up pending, all information received.									U	11/15/2003	11/15/2003	0		UNK	UNK					PJP200400037	1						1	Medication error	FLU3~EVANS VACCINES~765952~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230977	12/14/2004		2.0	2	.0	F	10/08/2004	Administration to a child under 4 years of age (Medication Error, Medication Error) (Med Error) - not reported  A report was received from a health care professional on 25 November 2003, concerning a 2 year old female vaccinee who advertently received Fluvirin on 21 November 2003. On 21 November 2003 the vacinee inadvertently received 0.25ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11 March 2004: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow-up pending, all information received.									U	11/21/2003	11/21/2003	0		UNK	UNK					PJP200400038	1						1	Medication error	FLU3~EVANS VACCINES~765952~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230978	12/14/2004		2.0			M		A report was received from a health care professional on 25 November 2003, concerning a 2 year old male vaccine who inadvertently received Fluvirin on 14 November 2003.  On 14 November 2003 the vaccine inadvertently received 0.25ml of Fluvirin.  At the time of the report no adverse events had been reported.  There was insufficient information to determine the reporter's causality assessment.  Update 1, 11 March 2004:  Further information received from a health care professional indicated that the vaccine did not experience any adverse reaction at the time of the report.  No follow-up pending, all information received.									U		11/14/2003			UNK	UNK					PJP200400039	1						1	Medication error	FLU3~EVANS VACCINES~765952~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230979	12/14/2004		0.61	0	.6	M	10/08/2004	A report was received from a health care professional on 25Nov03, concerning a 7 month old male vaccinee who inadvertently received Fluvirin on 20Nov03. On 20Nov03 the vaccinee inadvertently received 0.25ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporters causality assessment. Update 1, 11March04: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received. See Ref: PJP200301183, PJP200400053, PJP200400052, PJP200400051, PJP200400050, PJP200400049, PJP200400048, PJP200400047, PJP200400046, PJP200400045, PJP200400044, PJP200400043, PJP200400042, PJP200400041, PJP200400036, PJP200400039, PJP200400038, PJP200400037.									U	11/20/2003	11/20/2003	0		UNK	UNK	NONE		NONE		PJP200400040	1						1	Unevaluable event	FLU3~EVANS VACCINES~765952~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230980	12/14/2004		1.34	1	.3	F	10/08/2004	A report was received from a health care professional on 25Nov03, concerning a 16 month old female vaccinee who inadvertently received Fluvirin on 21Nov03. On 21Nov03 the vaccinee inadvertently received 0.25ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporters causality assessment. Update 1, 11Mar04:Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received. See Ref: PJP200301183, PJP200400053, PJP200400052, PJP200400051, PJP200400050, PJP200400049, PJP200400048, PJP200400047, PJP200400046, PJP200400045, PJP200400044, PJP200400043, PJP200400042, PJP200400040, PJP200400039, PJP200400038,  PJP200400037.									U	11/21/2003	11/21/2003	0		UNK	UNK	NONE		NONE		PJP200400041	1						1	Unevaluable event	FLU3~EVANS VACCINES~765952~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230981	12/14/2004		1.75	1	.7	F	10/08/2004	A report was received from a health care professional on 25Nov03, concerning a 21 month old female vaccinee who inadvertently received Fluvirin on 19Nov03. On 19Nov03 the vaccinee inadvertently received 0.25ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporters causality assessment. Update 1, 11March04: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received. See Ref: PJP200301183, PJP200400053, PJP200400052, PJP200400051, PJP200400050, PJP200400049, PJP200400048, PJP200400047, PJP200400046, PJP200400045, PJP200400044, PJP200400043, PJP200400042, PJP200400041, PJP200400040, PJP200400039, PJP200400038, PJP200400037,PJP200400036.									U	11/19/2003	11/19/2003	0		UNK	UNK	NONE		NONE		PJP200400042	1						1	Unevaluable event	FLU3~EVANS VACCINES~765952~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230982	12/14/2004		2.0	2	.3	F	10/08/2004	A report was received from a health care professional on 25Nov03, concerning a 27 month old female vaccinee who inadvertently received Fluvirin on 18Nov03. On 18Nov03 the vaccinee inadvertently received 0.25ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporters causality assessment. Update 1, 11March04: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received. See Ref: PJP200301183, PJP200400053, PJP200400052, PJP200400051, PJP200400050, PJP200400049, PJP200400048, PJP200400047, PJP200400046, PJP200400045, PJP200400044, PJP200400042, PJP200400041, PJP200400040, PJP200400039, PJP200400038, PJP200400037, PJP200400036.									U	11/18/2003	11/18/2003	0		UNK	UNK	NONE		NONE		PJP200400043	1						1	Unevaluable event	FLU3~EVANS VACCINES~765952~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230983	12/14/2004		3.0	2	.7	F	10/08/2004	A report was received from a health care professional on 25 November 2003, concerning a 31 month old female vaccinee who inadvertently received Fluvirin on 18 November 2003. On 18 November 2003 the vaccinee inadvertently received 0.25 ml of Fluvirin. AT the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11 March 2004: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received. See Ref: PJP200301183, PJP200400053, PJP200400052, PJP200400051, PJP200400050, PJP200400049, PJP200400048, PJP200400047, PJP200400046, PJP200400045, PJP200400043, PJP200400042, PJP200400041, PJP200400040, PJP200400039, PJP200400038, PJP100700037, PJP200400036.									U	11/18/2003	11/18/2003	0		UNK	UNK					PJP200400044	1						1	Medication error	FLU3~EVANS VACCINES~765952~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230984	12/14/2004		1.0	0	1	M	10/08/2004	A report was received from a health care professional on 25 November 2003, concerning a 11 month old male vaccinee who inadvertently received Fluvirin on 14 November 2003. On 14 November 2003 the vaccinee inadvertently received 0.25 ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11 March 2004: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received. See Ref: PJP200301183, PJP200400053, PJP200400052, PJP200400051, PJP200400050, PJP200400049, PJP200400048, PJP200400047, PJP200400046, PJP200400044, PJP200400043, PJP200400042, PJP200400041, PJP200400040, PJP200400039, PJP200400038, PJP200400037, PJP200400036.									U	11/14/2003	11/14/2003	0		UNK	UNK					PJP200400045	1						1	Medication error	FLU3~EVANS VACCINES~765952~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230985	12/14/2004		0.66	0	.7	M	10/08/2004	A report was received from a health care professional on 25 November 2003, concerning a 7 month old male vaccinee who inadvertently received Fluvirin on 20 November 2003. On 20 November 2003 the vaccinee inadvertently received 0.25 ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11 March 2004: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received. See Ref: PJP200301183, PJP200400053, PJP200400052, PJP200400051, PJP200400050, PJP200400049, PJP200400048, PJP200400047, PJP200400045, PJP200400044, PJP200400043, PJP200400042, PJP200400041, PJP200400040, PJP200400039, PJP200400038, PJP200400037, PJP200400036.									U	11/20/2003	11/20/2003	0		UNK	UNK					PJP200400046	1						1	Medication error	FLU3~EVANS VACCINES~765952~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230986	12/14/2004		0.65	0	.7	M	10/08/2004	A report was received from a health care professional on 25 November 2003, concerning a 7 month old male vaccinee who inadvertently received Fluvirin on 07 November 2003. On 07 November 2003 the vaccinee inadvertently received 0.25 ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11 March 2004: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received. See Ref: PJP200301183, PJP200400053, PJP200400052, PJP200400051, PJP200400050, PJP200400049, PJP200400048, PJP200400046, PJP200400045, PJP200400044, PJP200400043, PJP200400042, PJP200400041, PJP200400040, PJP200400039, PJP200400038, PJP200400037, PJP200400036.									U	11/07/2003	11/07/2003	0		UNK	UNK					PJP200400047	1						1	Medication error	FLU3~EVANS VACCINES~765952~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230987	12/14/2004		1.79	1	.8	F	10/08/2004	A report was received from a health care professional on 25 November 2003, concerning a 21 month old female vaccinee who inadvertently received Fluvirin on 18 November 2003. On 18 November 2003 the vaccinee inadvertently received 0.25 ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11 March 2004: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received. See Ref: PJP200301183, PJP200400053, PJP200400052, PJP200400051, PJP200400050, PJP200400049, PJP200400047, PJP200400046, PJP200400045, PJP200400044, PJP200400043, PJP200400042, PJP200400041, PJP200400040, PJP200400039, PJP200400038, PJP200400037, PJP200400036.									U	11/18/2003	11/18/2003	0		UNK	UNK					PJP200400048	1						1	Medication error	FLU3~EVANS VACCINES~765952~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230988	12/14/2004		4.0	3		F	10/08/2004	A report was received from a health care professional on 25 November 2003, concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 24 November 2003. On 24 November 2003 the vaccinee inadvertently received 0.25 ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11 March 2004: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received. See Ref: PJP200301183, PJP200400053, PJP200400052, PJP200400051, PJP200400050, PJP200400048, PJP200400047, PJP200400046, PJP200400045, PJP200400044, PJP200400043, PJP200400042, PJP200400041, PJP200400040, PJP200400039, PJP200400038, PJP200400037, PJP200400036.									U	11/24/2003	11/24/2003	0		UNK	UNK					PJP200400049	1						1	Medication error	FLU3~EVANS VACCINES~765952~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230989	12/14/2004		3.0	3		F	10/08/2004	A report was received from a health care professional on 25 November 2003, concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 05 November 2003. On 05 November 2003 the vaccinee inadvertently received 0.25 ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11 March 2004: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received. See Ref: PJP200301183, PJP200400053, PJP200400052, PJP200400051, PJP200400049, PJP200400048, PJP200400047, PJP200400046, PJP200400045, PJP200400044, PJP200400043, PJP200400042, PJP200400041, PJP200400040, PJP200400039, PJP200400038, PJP200400037, PJP200400036.									U	11/05/2003	11/05/2003	0		UNK	UNK					PJP200400050	1						1	Medication error	FLU3~EVANS VACCINES~765952~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230990	12/14/2004		3.0	2	.6	F	10/08/2004	A report was received from a health care professional on 25 November 2003, concerning a 30 month old female vaccinee who inadvertently received Fluvirin on 21 November 2003. On 21 November 2003 the vaccinee inadvertently received 0.25 ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11 March 2004: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received. See Ref: PJP200301183, PJP200400053, PJP200400052, PJP200400050, PJP200400049, PJP200400048, PJP200400047, PJP200400046, PJP200400045, PJP200400044, PJP200400043, PJP200400042, PJP200400041, PJP200400040, PJP200400039, PJP200400038, PJP200400037, PJP200400036.									U	11/21/2003	11/21/2003	0		UNK	UNK					PJP200400051	1						1	Medication error	FLU3~EVANS VACCINES~765952~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230991	12/14/2004		4.0	3		F	10/08/2004	A report was received from a health care professional on 25 November 2003, concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 07 November 2003. On 07 November 2003 the vaccinee inadvertently received 0.25 ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11 March 2004: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received. See Ref: PJP200301183, PJP200400053, PJP200400051, PJP200400050, PJP200400049, PJP200400048, PJP200400047, PJP200400046, PJP200400045, PJP200400044, PJP200400043, PJP200400042, PJP200400041, PJP200400040, PJP200400039, PJP200400038, PJP200400037, PJP200400036.									U	11/07/2003	11/07/2003	0		UNK	UNK					PJP200400052	1						1	Medication error	FLU3~EVANS VACCINES~765952~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230992	12/14/2004		3.0	3		F	10/08/2004	A report was received from a health care professional on 25 November 2003, concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 12 November 2003. On 12 November 2003 the vaccinee inadvertently received 0.25 ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11 March 2004: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received. See Ref: PJP200301183, PJP200400052, PJP200400051, PJP200400050, PJP200400049, PJP200400048, PJP200400047, PJP200400046, PJP200400045, PJP200400044, PJP200400043, PJP200400042, PJP200400041, PJP200400040, PJP200400039, PJP200400038, PJP200400037, PJP200400036.									U	11/12/2003	11/12/2003	0		UNK	UNK					PJP200400053	1						1	Medication error	FLU3~EVANS VACCINES~765952~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230993	12/14/2004		1.46	1	.5	M	10/08/2004	A report was received from a health care professional on 09Jan04 concerning a 16 month old male vaccinee who inadvertently received Fluvirin on 09Jan04. On 09Jan04 the vaccinee inadvertently received Fluvirin. The vaccinee did not exhibit any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1, 08Mar04. Follow up information received from a health care professional indicated that the vaccinee was 17 months old at the time of vaccination. No adverse events were reported to date. No follow up pending, all information received.									U	01/09/2004	01/09/2004	0		UNK	UNK	Vitamins, Fluzone (inj) approx Dec03 0.25ml		Allergy to milk products since birth.		PJP200400058	1						1	Unevaluable event	FLU3~EVANS VACCINES~765410~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230995	12/14/2004					M	10/08/2004	A report was received from a health care professional on 09Oct03 concerning two vaccinees of unk demography who experienced fever, night sweats, stiff joints and headache on 07Oct03 after receiving Fluvirin vaccine on 07Oct03. On 07Oct03, two vaccines received Fluvirin and later that evening they both experienced fever of 101-102 degrees F, night sweats, stiff joints and headache. The vaccinees symptoms improved on 09Oct03. There was insufficient information to determine the reporter's causality assessment. No follow up pending as the reporter will not collect any further information. Update 1, 17Dec03. A follow up report was received from a health care professional concerning a male vaccinee, of unspecified age who experienced fever, night sweats, stiff joints, headache and achiness all over on 07Oct03 after receiving Fluvirin vaccine on the same day. On 07Oct03 the vaccinee experienced fever, night sweats, stiff joints, headache and achiness all over following Fluvirin vaccination. No follow up pending as the reporter will not collect any further information. Cross Reference with PJP200300788.									U	10/07/2003	10/07/2003	0		UNK	UNK	NONE		NONE		PJP200400060	1						1	Arthralgia; Headache; Myalgia; Night sweats; Pyrexia	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230996	12/14/2004		1.58			M	10/08/2004	A report was received from a consumer on 12Jan04 concerning a 19 month old male vaccinee who received Fluvirin on 11Dec03. On 11Dec03, the vaccinee received 0.5ml Fluvirin. The vaccinee did not complain of any adverse reaction. Follow up pending.									U	12/11/2003	12/11/2003	0		UNK	UNK	NONE		NONE		PJP200400062	1						1	Unevaluable event	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230997	12/14/2004		3.0	2	1	M	10/08/2004	A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400064, PJP200400065, PJP200400066, PJP200400067, PJP200400068, PJP200069, PJP200400070, PJP200400071, PJP200400072, PJP200400073, PJP200400074, PJP20040075, PJP200400076, PJP200400077, PJP200400078, PJP200400079.									U	11/07/2003	11/07/2003	0		UNK	UNK	NONE		NONE		PJP200400063	1						1	Unevaluable event	FLU3~EVANS VACCINES~765877~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0230999	12/14/2004		3.0	3		M	10/08/2004	A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400066, PJP200400067, PJP200400068, PJP200400069, PJP200400070, PJP200400071, PJP200400072, PJP200400073, PJP200400074, PJP200400075, PJP200400076, PJP200400077, PJP200400078, PJP200400079.									U	11/06/2003	11/06/2003	0		UNK	UNK	NONE		NONE		PJP200400065	1						1	Unevaluable event	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231000	12/14/2004		3.0	2	.9	F	10/08/2004	A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400065, PJP200400067, PJP200400068, PJP200400069, PJP200400070, PJP200400071, PJP200400072, PJP200400073, PJP200400074, PJP200400075, PJP200400076, PJP200400077, PJP200400078, PJP200400079.									U	11/07/2003	11/07/2003	0		UNK	UNK	NONE		NONE		PJP200400066	1						1	Unevaluable event	FLU3~EVANS VACCINES~765795~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231001	12/14/2004		2.0	2	.1	F	10/08/2004	A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400065, PJP200400066, PJP200400068, PJP200400069, PJP200400070, PJP200400071, PJP200400072, PJP200400073, PJP200400074, PJP200400075, PJP200400076, PJP200400077, PJP200400078, PJP200400079.									U	11/07/2003	11/07/2003	0		UNK	UNK	NONE		NONE		PJP200400067	1						1	Unevaluable event	FLU3~EVANS VACCINES~765877~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231002	12/14/2004		3.0	2	.6	M	10/08/2004	A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400065, PJP200400066, PJP200400067, PJP200400069, PJP200400070, PJP200400071, PJP200400072, PJP200400073, PJP200400074, PJP200400075, PJP200400076, PJP200400077, PJP200400078, PJP200400079.									U	11/17/2003	11/17/2003	0		UNK	UNK	NONE		NONE		PJP200400068	1						1	Unevaluable event	FLU3~EVANS VACCINES~765795~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231003	12/14/2004		0.74	0	.7	M	10/08/2004	A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400065, PJP200400066, PJP200400067, PJP200400068, PJP200400070, PJP200400071, PJP200400072, PJP200400073, PJP200400074, PJP200400075, PJP200400076, PJP200400077, PJP200400078, PJP200400079.									U	11/11/2003	11/11/2003	0		UNK	UNK	NONE		NONE		PJP200400069	1						1	Unevaluable event	FLU3~EVANS VACCINES~765877~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231004	12/14/2004		0.82	0	.8	F	10/08/2004	A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400065, PJP200400066, PJP200400067, PJP200400068, PJP200400069, PJP200400071, PJP200400072, PJP200400073, PJP200400074, PJP200400075, PJP200400076, PJP200400077, PJP200400078, PJP200400079.									U	11/18/2003	11/18/2003	0		UNK	UNK	NONE		NONE		PJP200400070	1						1	Unevaluable event	FLU3~EVANS VACCINES~765795~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231005	12/14/2004		2.0	2	.4	F	10/08/2004	A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400065, PJP200400066, PJP200400067, PJP200400068, PJP200400069, PJP200400070, PJP200400072, PJP200400073, PJP200400074, PJP200400075, PJP200400076, PJP200400077, PJP200400078, PJP200400079.									U	11/10/2003	11/10/2003	0		UNK	UNK	NONE		NONE		PJP200400071	1						1	Unevaluable event	FLU3~EVANS VACCINES~765877~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231006	12/14/2004		1.09	1	.1	F	10/08/2004	A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400065, PJP200400066, PJP200400067, PJP200400068, PJP200400069, PJP200400070, PJP200400071, PJP200400073, PJP200400074, PJP200400075, PJP200400076, PJP200400077, PJP200400078, PJP200400079.									U	11/14/2003	11/14/2003	0		UNK	UNK	NONE		NONE		PJP200400072	1						1	Unevaluable event	FLU3~EVANS VACCINES~765877~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231007	12/14/2004		1.47	1	.5	M	10/08/2004	A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400065, PJP200400066, PJP200400067, PJP200400068, PJP200400069, PJP200400070, PJP200400071, PJP200400072, PJP200400074, PJP200400075, PJP200400076, PJP200400077, PJP200400078, PJP200400079.									U	11/11/2003	11/11/2003	0		UNK	UNK	NONE		NONE		PJP200400073	1						1	Unevaluable event	FLU3~EVANS VACCINES~765877~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231008	12/14/2004		3.0	3		F	10/08/2004	A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400065, PJP200400066, PJP200400067, PJP200400068, PJP200400069, PJP200400070, PJP200400071, PJP200400072, PJP200400073, PJP200400075, PJP200400076, PJP200400077, PJP200400078, PJP200400079.									U	11/12/2003	11/12/2003	0		UNK	UNK	NONE		NONE		PJP200400074	1						1	Unevaluable event	FLU3~EVANS VACCINES~765877~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231009	12/14/2004		3.0	3		M	10/08/2004	A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400065, PJP200400066, PJP200400067, PJP200400068, PJP200400069, PJP200400070, PJP200400071, PJP200400072, PJP200400073, PJP200400075, PJP200400076, PJP200400077, PJP200400078, PJP200400079.									U	11/13/2003	11/13/2003	0		UNK	UNK	NONE		NONE		PJP200400075	1						1	Unevaluable event	FLU3~EVANS VACCINES~765877~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231010	12/14/2004		3.0	3		M	10/08/2004	A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400065, PJP200400066, PJP200400067, PJP200400068, PJP200400069, PJP200400070, PJP200400071, PJP200400072, PJP200400073, PJP200400074, PJP200400075, PJP200400077, PJP200400078, PJP200400079.									U	11/08/2003	11/08/2003	0		UNK	UNK	NONE		NONE		PJP200400076	1						1	Unevaluable event	FLU3~EVANS VACCINES~765877~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231011	12/14/2004		3.0	3		F	10/08/2004	A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400065, PJP200400066, PJP200400067, PJP200400068, PJP200400069, PJP200400070, PJP200400071, PJP200400072, PJP200400073, PJP200400074, PJP200400075, PJP200400076, PJP200400078, PJP200400079.									U	11/07/2003	11/07/2003	0		UNK	UNK	NONE		NONE		PJP200400077	1						1	Unevaluable event	FLU3~EVANS VACCINES~765795~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231012	12/14/2004		1.39	1	.4	F	10/08/2004	A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400065, PJP200400066, PJP200400067, PJP200400068, PJP200400069, PJP200400070, PJP200400071, PJP200400072, PJP200400073, PJP200400074, PJP200400075, PJP200400076, PJP200400077, PJP200400079.									U	11/07/2003	11/07/2003	0		UNK	UNK	NONE		NONE		PJP200400078	1						1	Unevaluable event	FLU3~EVANS VACCINES~765795~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231013	12/14/2004		1.35	1	.4	F	10/08/2004	A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400065, PJP200400066, PJP200400067, PJP200400068, PJP200400069, PJP200400070, PJP200400071, PJP200400072, PJP200400073, PJP200400074, PJP200400075, PJP200400076, PJP200400077, PJP200400078.									U	11/11/2003	11/11/2003	0		UNK	UNK					PJP200400079	1						1	Unevaluable event	FLU3~EVANS VACCINES~765877~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231014	12/14/2004		2.5			F	10/08/2004	A report was received from a health care professional on 13Jan04 concerning a 2.5 year old female vaccinee who received Fluvirin on 12Jan04. On 12Jan04 the vaccinee received Fluvirin. The vaccinee did not have any complaint as a result. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	01/12/2004	01/12/2004	0		UNK	UNK	NONE		NONE		PJP200400080	1						1	Unevaluable event	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231015	12/14/2004		49.0	48		F	10/08/2004	A report was received from a health care professional on 13Jan04, concerning a 48 year old female who developed generalized myalgia and fatigue 5 days after she received Fluvirin on 20Nov03. On 20Nov03 the vaccinee received Fluvirin. On 25Nov03 the vaccinee began experiencing generalized myalgia. The fatigue and myalgia have persisted and were still present at the time of reporting. The vaccinee is being followed by her general practitioner who is in the process of determining the cause of her fatigue. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	11/20/2003	11/25/2003	5		UNK	UNK	NONE		NONE		PJP200400081	1						1	Fatigue; Myalgia	FLU3~EVANS VACCINES~766051~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231016	12/14/2004		1.8	1	.8	M	10/08/2004	A report was received from a health care professional on 13Jan04, concerning a 21 month old male vaccinee who inadvertently received Fluvirin on 13Jan04. On 13Jan04, the vaccinee inadvertently received Fluvirin. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 01Mar04, follow up information received from a health care professional indicated that the vaccinee did not experience any adverse events following inadvertent Fluvirin vaccination. No follow up pending, all information received.									U	01/13/2004	01/13/2004	0		UNK	UNK	NONE		NONE		PJP200400082	1						1	Unevaluable event	FLU3~EVANS VACCINES~765621~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231017	12/14/2004		3.0	2	.9	F	10/08/2004	A report was received from a health professional on 05Dec03, concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 26Nov03. On 26Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200301247, PJP200400085, PJP200400086.									U	11/26/2003	11/26/2003	0		UNK	UNK	NONE		NONE		PJP200400084	1						1	Unevaluable event	FLU3~EVANS VACCINES~765667~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231018	12/14/2004		0.54	0	.5	F	10/08/2004	A report was received from a health professional on 05Dec03, concerning a 6 month old male vaccinee who inadvertently received Fluvirin on 28Nov03. On 28Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200301247, PJP200400084, PJP200400086.									U	11/28/2003	11/28/2003	0		UNK	UNK	NONE		NONE		PJP200400085	1						1	Unevaluable event	FLU3~EVANS VACCINES~765667~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231019	12/14/2004		4.0	3		F	10/08/2004	A report was received from a health professional on 05Dec03, concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 01Dec03. On 01Dec03 the vaccinee inadvertently received Fluvirin. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200301247, PJP200400084, PJP200400085.									U	12/01/2003	12/01/2003	0		UNK	UNK	NONE		NONE		PJP200400086	1						1	Unevaluable event	FLU3~EVANS VACCINES~765667~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231020	12/14/2004					U	10/08/2004	A report was received from a health care professional on 15Dec03 concerning approximately 10 children of unk sex and less than 4 years of age who inadvertently received Fluvirin between the 22Oct03 and 10Dec03. Between 22Oct03 and 10Dec03 approx 10 children inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with PJP200301313.									U	10/22/2003	10/22/2003	0		UNK	UNK	NONE		NONE		PJP200400091	1						1	Unevaluable event	FLU3~EVANS VACCINES~766054~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231021	12/14/2004		3.0			M	10/08/2004	A report was received from a health professional on 16Jan04  concerning a 3 year old male vaccinee who inadvertently received Fluvirin on an unspecified date. On an unspecified date the vaccinee inadvertently received 0.25ml.  It was reported that the administration did not cause the vaccinee harm. There was insufficient information to determine the reporter's causality assessment. Follow up pending.  See reference: PJP200400102.									U					UNK	UNK	NONE		NONE		PJP200400092	1						1	Unevaluable event	FLU3~EVANS VACCINES~765484~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231022	12/14/2004		3.0			M	10/08/2004	A report was received from a health care professional on 12/2/03 concerning an unspecified number (approximately 5 to 6) vaccinees under 4 years of age who inadvertently received Fluvirin on unspecified dates. On unspecified dates, the vaccinee inadvertently received Fluvirin 0.5ml IM. The vaccinees did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1/20/04: A follow up report was received from a health care professional concerning a 3 year old male vaccinee who inadvertently received Fluvirin on 11/5/03. On 11/5/03 the vaccinee inadvertently received Fluvirin. No adverse effects were reported at the time of reporting. No follow up pending. All information received.									U	11/05/2003	11/05/2003	0		UNK	UNK	NONE		NONE		PJP200400094	1						1	Medication error	FLU3~EVANS VACCINES~765957~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231023	12/14/2004		3.0			M	10/08/2004	A report was received from a health care professional on 12/2/03 concerning an unspecified number (approximately 5 to 6) vaccinees under 4 years of age who inadvertently received Fluvirin on unspecified dates. On unspecified dates, the vaccinees inadvertently received Fluvirin 0.5ml IM. The vaccinees did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1/20/04: A follow up report was received from a health care professional concerning a 3 year old male vaccine who inadvertently received Fluvirin on 11/5/03. On 11/5/03 the vaccinee inadvertently received Fluvirin. No adverse effects were reported at the time of reporting. No follow up pending. All information received.									U	11/05/2003	11/05/2003	0		UNK	UNK	NONE		NONE		PJP200400095	1						1	Medication error	FLU3~EVANS VACCINES~765957~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231024	12/14/2004		4.0	3		F	10/08/2004	A report was received from a health care professional on 12/2/03 concerning an unspecified number (approximately 5 to 6) vaccinees under 4 years of age who inadvertently received Fluvirin on unspecified dates. On unspecified dates, the vaccinees inadvertently received Fluvirin 0.5ml IM> The vaccinees did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1/20/04: A follow up report was received from a health care professional concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 11/17/03. On 11/17/03 the vaccinee inadvertently received Fluvirin. No adverse effects were reported at the time of reporting. No follow up pending. All information received.									U	11/17/2003	11/17/2003	0		UNK	UNK	NONE		NONE		PJP200400096	1						1	Medication error	FLU3~EVANS VACCINES~766053~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231025	12/14/2004		0.67	0	.7	M	10/08/2004	A report was received from a health care professional on 12/2/03 concerning an unspecified number (approximately 5 to 6) vaccinees under 4 years of age who inadvertently received Fluvirin on unspecified dates. On unspecified dates, the vaccinees inadvertently received Fluvirin 0.5ml IM. The vaccinees did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1/20/04: A follow up report was received from a health care professional concerning an 8 month old male vaccinee who inadvertently received Fluvirin on 11/20/03. On 11/20/03 the vaccinee inadvertently received Fluvirin. No adverse effects were reported at the time of reporting. No follow up pending. All information received.									U	11/20/2003	11/20/2003	0		UNK	UNK	NONE		NONE		PJP200400097	1						1	Medication error	FLU3~EVANS VACCINES~765501~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231026	12/14/2004		0.59	0	.6	F	10/08/2004	A report was received from a health care professional on 12/2/03 concerning an unspecified number (approximately 5 to 6) vaccinees under 4 years of age who inadvertently received Fluvirin on unspecified dates. On unspecified dates, the vaccinees inadvertently received Fluvirin 0.5ml IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1/20/04: A follow up report was received from a health care professional concerning a 7 month old female vaccinee who inadvertently received Fluvirin on 11/25/03. On 11/25/03 the vaccinee inadvertently received Fluvirin. No adverse effects were reported at the time of reporting. No follow up pending. All information received.									U	11/25/2003	11/25/2003	0		UNK	UNK	NONE		NONE		PJP200400101	1						1	Medication error	FLU3~EVANS VACCINES~766053~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231027	12/14/2004		2.0	2	.2	F	10/08/2004	A report was received from a consumer on 1/20/04 concerning a 2.5 year old female vaccinee who inadvertently received 0.25ml Fluvirin on an unspecified date in December 2003 and on 1/9/04 inadvertently received a booster vaccine of 0.25ml Fluvirin. On an unspecified date in December 2003, the vaccinee inadvertently received 0.25ml Fluvirin and on 1/9/04 inadvertently received a booster vaccine of 0.25ml Fluvirin. At the time of the report no adverse events had been reported. Update 2/23/04: Follow up information received received from a health care professional indicated that the vaccinee received Fluzone on 12/5/03 instead of Fluvirin as previously recorded. The vaccinee did not have experience any adverse reactions. No follow up pending.									U	01/09/2004	01/09/2004	0		UNK	UNK	Amoxicillin; Cefzil; Zithromax; Zyrtec; Tylenol; Omnicef; Tobrex				PJP200400105	1						1	Medication error	FLU3~EVANS VACCINES~766053~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231028	12/14/2004		45.0	45		M	10/08/2004	A report was received from a health care professional on 1/21/04 concerning a 45 year old male vaccinee who developed low frequency tinnitus lasting several months, 2 weeks after he received Fluvirin on 10/14/02. On 10/14/02 the vaccinee received Fluvirin. About 2 weeks later in November 2002 he developed a low frequency tinnitus that lasted several months and resolved by late summer 2003. In fall 2003, the vaccinee received Fluzone and the tinnitus returned. According to the vaccinee at the time of reporting the symptoms had mostly resolved, but are not 100% resolved. There was insufficient information to determine the reporter's causality assessment. Follow up pending									U	10/14/2002	10/28/2002	14		UNK	UNK	NONE		NONE		PJP200400110	1						1	Tinnitus	FLU3~EVANS VACCINES~E35792KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231029	12/14/2004					U	10/08/2004	A report was received from a health care professional on 12/8/03 concerning an unknown number of children of unspecified sex and less than 4 years of age who inadvertently received Fluvirin on an unknown date. On an unknown date, an unspecified number of children less than 4 years of age inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200400111	1						1	Medication error	FLU3~EVANS VACCINES~766053~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231030	12/14/2004		1.36	1	.4	M	10/08/2004	A report was received from a health care professional on 12/3/03 concerning eight vaccinees of unspecified sex and under 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date, eight vaccinees under 4 years of age inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality. Update 1/20/04: Follow up information received from a health care professional indicated that a 16 month old male vaccinee inadvertently received Fluvirin on 11/21/03. No follow up pending.									U	11/21/2003	11/21/2003	0		UNK	UNK	NONE		NONE		PJP200400112	1						1	Medication error	FLU3~EVANS VACCINES~765497~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231031	12/14/2004		2.0	2	.1	F	10/08/2004	A report was received from a health care professional on 12/3/03 concerning eight vaccinees of unspecified sex and under 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date, eight vaccinees under 4 years of age inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality. Update 1/20/04: Follow up information received from a health care professional indicated that a 2 year old female vaccinee inadvertently received Fluvirin on 11/18/03. No follow up pending.									U	11/18/2003	11/18/2003	0		UNK	UNK	NONE		NONE		PJP200400113	1						1	Medication error	FLU3~EVANS VACCINES~765497~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231032	12/14/2004		2.0	2	.2	M	10/08/2004	A report was received from a health care professional on 12/3/03 concerning eight vaccinees of unspecified sex and under 4 years of age who inadvertently received Fluvirin on an unspecified date. On an  unspecified date, eight vaccinees under 4 years of age inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality. Update 1/20/04: Follow up information received from a health care professional indicated that a 2 year old male vaccinee inadvertently received Fluvirin on 11/26/03. No follow up pending.									U	11/26/2003	11/26/2003	0		UNK	UNK	NONE		NONE		PJP200400114	1						1	Medication error	FLU3~EVANS VACCINES~765497~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231033	12/14/2004		4.0	3		F	10/08/2004	A report was received from a health care professional on 12/03/03 concerning eight vaccinees of unspecified sex and under 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date, eight vaccinees under 4 years of age inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality. Update 1/20/04: Follow up information received from a health care professional indicated that a 3.5 year old female vaccinee inadvertently received Fluvirin on 11/18/03. No follow up pending.									U	11/18/2003	11/18/2003	0		UNK	UNK	NONE		NONE		PJP200400115	1						1	Medication error	FLU3~EVANS VACCINES~765497~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231034	12/14/2004		30.0			F	10/08/2004	A report was received from a health care professional on 1/27/04 concerning a 30 year old female vaccinee who developed soreness in her arm after she received Fluvirin on 12/10/03, while she was 15 weeks pregnant. On 12/10/03, the vaccinee received Fluvirin into her right deltoid. The vaccinee reported that her arm was sore for a week afterwards and then resolved completely. After Christmas holidays the vaccinee developed a minor cold and reported that her arm began to feel sore again. The vaccinee experienced 2 additional episodes of minor cold/illness during which the soreness in her arm returned. This was the vaccinee's first experience to the influenza vaccine. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	12/10/2003	12/10/2003	0		UNK	UNK	NONE		NONE		PJP200400117	1						1	Medication error; Pain; Pharyngitis; Rhinitis	FLU3~EVANS VACCINES~765795~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231035	12/14/2004					F	10/08/2004	A report was received from a health care professional on 1/28/04 concerning a female vaccinee of unspecified age who developed redness and soreness at the injection site after inadvertently receiving a sub-optimal dose (0.1ml) of Fluvirin ID on 1/26/04, instead of Tuberculin skin test. On 1/26/04 the vaccinee received 0.1ml Fluvirin ID instead of Tuberculin skin test. The vaccinee has complained of redness and soreness at the injection site. There was insufficient information to determine the reporter's causality assessment. Update 3/12/04: Further information was received from a health care professional indicating that the vaccinee experienced redness and soreness at the injection site on 1/28/04 which lasted for 2 days. The vaccinee did not experience any further effects. Follow up pending.									U	01/26/2004	01/26/2004	0		UNK	UNK	NONE		NONE		PJP200400118	1						1	Injection site erythema; Injection site pain; Medication error	FLU3~EVANS VACCINES~~UNK~ID~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231036	12/14/2004					U	10/08/2004	A report was received from a health care professional on 1/30/04 concerning approximately 40 vaccinees under 4 years of age and of unknown gender, who inadvertently received Fluvirin on unspecified dates in December 2003 and January 2004. On unspecified dates in December 2003 and January 2004 the vaccinee inadvertently received Fluvirin. No adverse effects were reported at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U					UNK	UNK	NONE		NONE		PJP200400122	1						1	Medication error	FLU3~EVANS VACCINES~766050~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231037	12/14/2004		1.37	1	.4	F	10/08/2004	A report was received from a health care professional on 2/3/04 concerning a 15 month old female vaccinee who inadvertently received Fluvirin on 2/3/04. On 2/3/04 the vaccinee inadvertently received Fluvirin. No adverse effects were reported at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 5/4/04: A follow up report received from a health care professional indicated that the vaccinee was 16 months old and experienced a slightly sore leg but no fever on the same day as receiving Fluvirin on 2/3/04. The vaccinee had also received Fluzone on a different side on 1/2/04. The vaccinee recovered on an unspecified date. No follow up pending. All information received.									U	02/03/2004	02/03/2004	0		UNK	UNK			NONE		PJP200400123	1						1	Medication error; Pain	FLU3~EVANS VACCINES~765886~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231038	12/14/2004					F	10/08/2004	A report was received from a health care professional on 2/4/04 concerning a female vaccinee of approximately 72 years of age who experienced a sore throat, flu-like symptoms and bilateral lower extremity weakness after receiving Fluvirin on an unspecified date in October 2003. The vaccinee had a previous history of neuropathy in her feet. On an unspecified date in October 2003, the vaccinee experienced a sore throat in the evening after receiving Fluvirin. A few days later, the vaccinee developed mild flu-like symptoms. At the time of the report, the vaccinee was experiencing bilateral lower extremity weakness which was greater in the right than in the left. The outcome of the events was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	10/01/2003	10/01/2003	0		UNK	UNK	NONE		Neuropathy in her feet.		PJP200400124	1						1	Influenza like illness; Muscular weakness; Pharyngolaryngeal pain	FLU3~EVANS VACCINES~765980~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231039	12/14/2004		5.0			M	10/08/2004	A report was received from a health care professional on 2/4/04 concerning a 5 year old male vaccinee who inadvertently received half of the correct dose of Fluvirin on an unspecified date. On an unreported date, the vaccinee received 0.25ml Fluvirin. The vaccinee did not experience any adverse events at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/15/04: Further information was received from a health care professional indicated that the vaccinee received half of the correct dose of Fluvirin on 12/3/03. The outcome was unknown at the time of the report. The vaccinee received a second dose of Fluvirin at the correct dose on 1/8/04. Follow up pending.									U	12/03/2003	12/03/2003	0		UNK	UNK	NONE		NONE		PJP200400125	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~765958~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231040	12/14/2004		8.0			F	10/08/2004	A report was received from a health care professional on 2/4/04 concerning an 8 year old female vaccinee who inadvertently received half of the correct dose of Fluvirin on an unspecified date. On an unspecified date, the vaccinee received 0.25ml Fluvirin. The vaccinee did not experience any adverse events at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/15/04: Further information received from a health care professional indicated that the vaccinee received half of the correct dose of Fluvirin on 12/3/03. The outcome was unknown at the time of the report. The vaccinee received a second dose of Fluvirin at the correct dose on 1/8/04. Follow up pending.									U	12/03/2003	12/03/2003	0		UNK	UNK	NONE		NONE		PJP200400126	1						1	Medication error	FLU3~EVANS VACCINES~765958~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231041	12/14/2004		3.0			U	10/08/2004	A report was received from a health care professional on 2/5/04 concerning a 3 and a half year old vaccinee of unspecified gender who inadvertently received Fluvirin on 1/29/04. On 1/29/04 the vaccinee inadvertently received Fluvirin. No adverse effects were reported at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	01/29/2004	01/29/2004	0		UNK	UNK	NONE		NONE		PJP200400127	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231042	12/14/2004		3.0			F	10/08/2004	A report was received from a health care professional on 2/16/04 concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 12/5/03. On 12/5/03, the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. No follow up pending.									U	12/05/2003	12/05/2003	0		UNK	UNK	NONE		NONE		PJP200400134	1						1	Medication error	FLU3~EVANS VACCINES~766053~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231043	12/14/2004		1.0			F	10/08/2004	A report was received from a health care professional on 2/16/04 concerning a 1 year old female vaccinee who inadvertently received Fluvirin on 12/5/03. On 12/5/03, the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. No follow up pending.									U	12/05/2003	12/05/2003	0		UNK	UNK	NONE		NONE		PJP200400135	1						1	Medication error	FLU3~EVANS VACCINES~765143~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231044	12/14/2004		2.0			F	10/08/2004	A report was received from a health care professional on 2/16/04 concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 10/31/03 and 12/3/03. On 10/31/03 and 12/3/03, the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. No follow up pending.									U	10/31/2003	10/31/2003	0		UNK	UNK	NONE		NONE		PJP200400136	1						1	Medication error	FLU3~EVANS VACCINES~766053~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231045	12/14/2004		3.0			M	10/08/2004	A report was received from a health care professional on 2/16/04 concerning a 3.5 year old male vaccinee who inadvertently received Fluvirin on 10/10/03 and 11/10/03. On 10/10/03 and 11/10/03, the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. No follow up pending.									U	10/10/2003	10/10/2003	0		UNK	UNK	NONE		NONE		PJP200400137	1						1	Medication error	FLU3~EVANS VACCINES~766053~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231046	12/14/2004		2.0			M	10/08/2004	A report was received from a health care professional on 2/16/04 concerning a 2 year old male vaccinee who inadvertently received Fluvirin on 11/13/03. On 11/13/03, the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. No follow up pending.									U	11/13/2003	11/13/2003	0		UNK	UNK	NONE		NONE		PJP200400138	1						1	Medication error	FLU3~EVANS VACCINES~766053~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231047	12/14/2004		44.0			F	10/08/2004	A report was received from a health care professional on 10/29/03 concerning an unspecified number of vaccinees of unspecified demography who experienced localized hives, swelling, redness and itching and unspecified length of time after receiving Fluvirin on an unknown date. On an unknown date an unspecified number of vaccinees experienced localized hives, swelling, redness and itching on an unspecified length of time after receiving Fluvirin. The reporter noted many more local adverse effects than usual with the 2003-2004 Fluvirin. It was not reported if the vaccinee's had recovered at the time of the report. There was insufficient information to determine the reporter's causality. Update 2/16/04: A follow up report was received from a health care professional indicating that a 44 year old female vaccinee developed redness and swelling at the injection site, which was also itchy after receiving Fluvirin on 10/14/03. The outcome of the adverse events was not reported at the time of reporting. Update 4/16/04: Further follow up information received from a health care professional indicated that the vaccinee's symptoms resolved and no further symptoms were reported as of April 2004. No follow up pending. All information received.									U	10/14/2003	10/14/2003	0		UNK	UNK	NONE		NONE		PJP200400141	1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Pruritus; Urticaria	FLU3~EVANS VACCINES~765499~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231048	12/14/2004		11.0			F	10/08/2004	A report was received from a health care professional on 10/29/03 concerning an unspecified number of vaccinees of unspecified demography who experienced localized hives, swelling, redness and itching an unspecified length of time after receiving Fluvirin on an unknown date. On an unknown date an unspecified number of vaccinees experienced localized hives, swelling, redness and itching on an unspecified length of time after receiving Fluvirin. The reporter noted many more local adverse effects than usual with the 2003-2004 Fluvirin. It was not reported if the vaccinee's had recovered at the time of the report. There was insufficient information to determine the reporter's causality. Update 2/16/04: A follow up report was received from a health care professional indicating that an 11 year old female vaccinee developed an event described as red, swelling and itchy on 10/14/03, 1 day after receiving Fluvirin on 10/13/03. The outcome of the adverse event was not reported at the time of reporting. Update 4/16/04: Further follow up information received from a health care professional indicated that the vaccinee's symptoms resolved and no further symptoms were reported as of 4/04. No follow up pending. All information received.									Y	10/13/2003	10/13/2003	0		UNK	UNK	NONE		NONE		PJP200400142	1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Pruritus; Urticaria	FLU3~EVANS VACCINES~765499~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231049	12/14/2004					F	10/08/2004	A report was received from a health care professional on 10/29/03 concerning an unspecified number of vaccinees of unspecified demography who experienced localized hives, swelling, redness and itching an unspecified length of time after receiving Fluvirin on an unknown date. On an unknown date an unspecified number of vaccinees experienced localized hives, swelling, redness and itching of an unspecified length of time after receiving Fluvirin. The reporter noted many more local adverse effects than usual with the 2003-2004 Fluvirin. It was not reported if the vaccinee's had recovered at the time of the report. There was insufficient information to determine the reporter's causality. Update 2/16/04: A follow up report was received from a health care professional indicating that a female vaccinee of unspecified age developed redness and swelling at the injection site which was warm to touch after receiving Fluvirin on 10/16/03. The vaccinee also developed a fever. The outcome of the adverse events was not reported at the time of reporting. Update 4/16/04: Further follow up information received from a health care professional indicated that the vaccinee's symptoms resolved and no further symptoms were reported as of 4/04. No follow up pending.									U	10/16/2003	10/16/2003	0		UNK	UNK	NONE		NONE		PJP200400143	1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Injection site warmth; Pruritus; Pyrexia; Urticaria	FLU3~EVANS VACCINES~765499~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231050	12/14/2004		44.0			F	10/08/2004	A report was received from a health care professional on 10/29/03 concerning an unspecified number of vaccinees of unspecified demography who experienced localized hives, swelling, redness and itching an unspecified length of time after receiving Fluvirin on an unknown date. On an unknown date an unspecified number of vaccinees experienced localized hives, swelling, redness and itching on an unspecified length of time after receiving Fluvirin. The reporter noted many more local adverse effects than usual with the 2003-2004 Fluvirin. It was not reported if the vaccinee's had recovered at the time of the report. There was insufficient information to determine the reporter's causality. Update 2/16/04: A follow up report was received from a health care professional indicating that a 44 year old female vaccinee developed redness and swelling at the injection site which was warm to touch after receiving Fluvirin on 10/27/03. The outcome of the adverse events was not reported at the time of reporting. Update 4/16/04: Further follow up information received from a health care professional indicated that the vaccinee's symptoms resolved and no further symptoms were reported as of 4/04. No follow up pending. All information received.									U	10/27/2003	10/27/2003	0		UNK	UNK	NONE		NONE		PJP200400144	1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Injection site warmth; Pruritus; Urticaria	FLU3~EVANS VACCINES~765499~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231051	12/14/2004		39.0			F	10/08/2004	A report was received from a health care professional on 10/29/03 concerning an unspecified number of vaccinees of unspecified demography who experienced localized hives, swelling, redness and itching an unspecified length of time after receiving Fluvirin on an unknown date. On an unknown date an unspecified number of vaccinees experienced localized hives, swelling, redness and itching on an unspecified length of time after receiving Fluvirin. The reporter noted many more local adverse effects than usual with the 2003-2004 Fluvirin. It was not reported if the vaccinee's had recovered at the time of the report. There was insufficient information to determine the reporter's causality. Update 2/16/04: A follow up report was received from a health care professional concerning a 39 year old female vaccinee who developed an injection site that was warm to touch. The vaccinee also experienced redness and itching after receiving Fluvirin on 10/14/03. The outcome of the adverse events was not reported at the time of reporting. Update 4/16/04: Further follow up information received from a health care professional indicated that the vaccinee's symptoms resolved and no further symptoms were reported as of 4/04. No follow up pending. All information received.									U	10/14/2003	10/14/2003	0		UNK	UNK	NONE		NONE		PJP200400145	1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Injection site warmth; Pruritus; Urticaria	FLU3~EVANS VACCINES~765499~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231052	12/14/2004		61.0			M	10/08/2004	A report was received from a health care professional on 2/24/04 concerning a 61 year old male vaccinee who inadvertently received expired Fluvirin on an unspecified date in September 2003. On an unspecified date in September 2003, the vaccinee was inadvertently administered a dose of 2002-2003 Fluvirin. No adverse events were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	09/01/2003	09/01/2003	0		UNK	UNK	NONE		NONE		PJP200400146	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231053	12/14/2004		16.0			F	10/08/2004	A report was received from a health care professional on 2/24/04 concerning a 16 year old female vaccinee who inadvertently received expired Fluvirin on an unspecified date in September 2003. On an unspecified date in September 2003, the vaccinee was inadvertently administered a dose of 2002-2003 Fluvirin. No adverse events were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	09/01/2003	09/01/2003	0		UNK	UNK	NONE		NONE		PJP200400147	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231055	12/14/2004		46.0			F	10/08/2004	A report was received from a health care professional on 2/24/04 concerning a 46 year old female vaccinee who inadvertently received expired Fluvirin on an unspecified date in September 2003. On an unspecified date in September 2003, the vaccinee was inadvertently administered a dose of 2002-2003 Fluvirin. No adverse events were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.									U	09/01/2003	09/01/2003	0		UNK	UNK	NONE		NONE		PJP200400148	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231056	12/14/2004		3.0			F	10/08/2004	A report was received from a health care professional on 2/24/04 concerning up to 8 vaccinees under 4 years of age and of unknown gender who inadvertently received a dose of Fluvirin vaccine on an unreported day in December 2003. On an unspecified day in December 2003, up to 8 vaccinees were inadvertently administered Fluvirin. The outcome of the event was not reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Further information was received from a health care professional indicating that the vaccinee was 47 month old female who inadvertently received 0.5ml Fluvirin on 12/10/03. No adverse events were reported at the time of the event. No follow up pending. All information received.									U	12/10/2003	12/10/2003	0		UNK	UNK	NONE		NONE		PJP200400149	1						1	Medication error	FLU3~EVANS VACCINES~766048~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231057	12/14/2004		3.0	3		M	10/08/2004	A report was received from a health care professional on 12/8/03 concerning five children of unspecified sex and aged between 8 months and 3 years of age who inadvertently received Fluvirin on 12/6/03. On 12/6/03, five children inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 3/8/04: Follow up information received from a health care professional indicated that a 3 year old male vaccinee inadvertently received Fluvirin on 12/6/03. No adverse reactions have been reported to date. No follow up pending. All information received.									U	12/06/2003	12/06/2003	0		UNK	UNK	NONE		NONE		PJP200400157	1						1	Medication error	FLU3~EVANS VACCINES~765749~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231058	12/14/2004		4.0	3		F	10/08/2004	A report was received from a health care professional on 12/8/03 concerning 5 children of unspecified sex and aged between 8 months and 3 years of age who inadvertently received Fluvirin on 12/6/03. On 12/6/03, five children inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 3/8/04: Follow up information received from a health care professional indicated that a 3.5 year old female vaccinee inadvertently received Fluvirin on 12/6/03. No adverse events have been reported to date. No follow up pending. All information received.									U	12/06/2003	12/06/2003	0		UNK	UNK	NONE		NONE		PJP200400158	1						1	Medication error	FLU3~EVANS VACCINES~765749~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231059	12/14/2004		3.0	2	.6	F	10/08/2004	A report was received from a health care professional on 12/8/03 concerning 5 children of unspecified sex and aged between 8 months and 3 years of age who inadvertently received Fluvirin on 12/6/03. On 12/6/03, five children inadvertently received Fluvirin. At the time of the report, no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 3/8/04: Follow up information received from a health care professional indicated that a 2.5 year old female vaccinee inadvertently received Fluvirin on 12/6/03. No adverse events have been reported to date. No follow up pending. All information received.									U	12/06/2003	12/06/2003	0		UNK	UNK	NONE		NONE		PJP200400159	1						1	Medication error	FLU3~EVANS VACCINES~765749~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231060	12/14/2004		1.56	1	.6	M	10/08/2004	A report was received from a health care professional on 12/8/03 concerning 5 children of unspecified sex and aged between 8 months and 3 years of age who inadvertently received Fluvirin on 12/6/03. On 12/6/03, five children inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 3/8/04: Follow up information received from a health care professional indicated that a 1.5 year old male vaccinee inadvertently received Fluvirin on 12/6/03. No adverse events have been reported to date. No follow up pending. All information received.									U	12/06/2003	12/06/2003	0		UNK	UNK	NONE		NONE		PJP200400160	1						1	Medication error	FLU3~EVANS VACCINES~765749~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231061	12/14/2004		1.6	1	.6	M	10/08/2004	A report was received from a health care professional on 12/8/03 concerning 5 children of unspecified sex and aged between 8 months and 3 years of age who inadvertently received Fluvirin on 12/6/03. On 12/6/03, five children inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 3/8/04: Follow up information was received from a health care professional indicated that a 1.5 year old male vaccinee inadvertently received Fluvirin on 12/6/03. No adverse events have been reported to date. No follow up pending. All information received.									U	12/06/2003	12/06/2003	0		UNK	UNK	NONE		NONE		PJP200400161	1						1	Medication error	FLU3~EVANS VACCINES~765749~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231062	12/14/2004		2.0	2	.5	M	10/08/2004	A report was received from a health care professional on 12/8/03 concerning 5 children of unspecified sex and aged between 8 months and 3 years of age who inadvertently received Fluvirin on 12/6/03. On 12/6/03, five children inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 3/8/04: Follow up information received from a health care professional indicated that a 2.5 year old male vaccinee inadvertently received Fluvirin on 12/6/03. No adverse events have been reported to date. No follow up pending. All information received.									U	12/06/2003	12/06/2003	0		UNK	UNK	NONE		NONE		PJP200400162	1						1	Medication error	FLU3~EVANS VACCINES~765749~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231063	12/14/2004		3.0	2	1	F	10/08/2004	A report was received from a health care professional on 3/1/04 concerning a 2.5 year old female vaccinee who inadvertently received Fluvirin on 12/4/03. On 12/4/03, the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. No follow up pending. All information received.									U	12/04/2003	12/04/2003	0		UNK	UNK	NONE		NONE		PJP200400163	1						1	Medication error	FLU3~EVANS VACCINES~766049~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231064	12/14/2004		3.0			M	10/08/2004	A report was received from a health care professional on 2/24/04 concerning up to 8 vaccinees under 4 years of age and of unknown gender who inadvertently received a dose of Fluvirin vaccine on an unreported day in December 2003. On an unspecified day in December 2003, up to 8 vaccinees were inadvertently administered Fluvirin. The outcome of the event was not reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Further information was received from a health care professional indicating that the vaccinee was a 3 and half year old male who inadvertently received 0.5ml Fluvirin on 12/30/03. No adverse events were reported at the time of the event. No follow up pending. All information received.									U	12/30/2003	12/30/2003	0		UNK	UNK	NONE		NONE		PJP200400169	1						1	Medication error	FLU3~EVANS VACCINES~766048~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231065	12/14/2004		3.0			M	10/08/2004	A report was received from a health care professional on 2/24/04 concerning up to 8 vaccinees under 4 years of age and of unknown gender who inadvertently received a dose of Fluvirin vaccine on an unreported day in December 2003. On an unspecified day in December 2003, up to 8 vaccinees were inadvertently administered Fluvirin. The outcome of the event was not reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Further information was received from a health care professional indicating that the vaccinee was a 39.5 month old male who inadvertently received 0.5ml Fluvirin on 1/23/04. No adverse events were reported at the time of the event. No follow up pending. All information received.									U	01/23/2004	01/23/2004	0		UNK	UNK	NONE		NONE		PJP200400170	1						1	Medication error	FLU3~EVANS VACCINES~766048~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231066	12/14/2004		3.0			M	10/08/2004	A report was received from a health care professional on 2/24/04 concerning up to 8 vaccinees under 4 years of age and of unknown gender who inadvertently received a dose of Fluvirin vaccine on an unreported day in December 2003. On an unspecified day in December 2003, up to 8 vaccinees were inadvertently administered Fluvirin. The outcome of the event was not reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Further information was received from a health care professional indicating that the vaccinee was a 40 month old male who inadvertently received 0.5ml Fluvirin on 12/24/03. No adverse events were reported at the time of the event. No follow up pending. All information received.									U	12/24/2003	12/24/2003	0		UNK	UNK	NONE		NONE		PJP200400171	1						1	Medication error	FLU3~EVANS VACCINES~766048~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231067	12/14/2004		3.0			F	10/08/2004	A report was received from a health care professional on 2/24/04 concerning up to 8 vaccinees under 4 years of age and of unknown gender who inadvertently received a dose of Fluvirin vaccine on an unreported day in December 2003. On an unspecified day in December 2003, up to 8 vaccinees were inadvertently administered Fluvirin. The outcome of the event was not reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Further information was received from a health care professional indicating that the vaccinee was a 40 month old female who inadvertently received 0.5ml Fluvirin on 1/15/04. No adverse events were reported at the time of the event. No follow up pending. All information received.									U	01/15/2004	01/15/2004	0		UNK	UNK	NONE		NONE		PJP200400172	1						1	Medication error	FLU3~EVANS VACCINES~766048~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231068	12/14/2004		3.0			F	10/08/2004	A report was received from a health care professional on 2/24/04 concerning up to 8 vaccinees under 4 years of age and of unknown gender who inadvertently received a dose of Fluvirin vaccine on an unreported day in December 2003. On an unspecified day in December 2003, up to 8 vaccinees were inadvertently administered Fluvirin. The outcome of the event was not reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Further information was received from a health care professional indicating that the vaccinee was a 39 month old female who inadvertently received 0.5ml Fluvirin on 12/15/03. No adverse events were reported at the time of the event. No follow up pending. All information received.									U	12/15/2003	12/15/2003	0		UNK	UNK	NONE		NONE		PJP200400173	1						1	Medication error	FLU3~EVANS VACCINES~766048~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231069	12/14/2004		3.0			F	10/08/2004	A report was received from a health care professional on 2/24/04 concerning up to 8 vaccinees under 4 years of age and of unknown gender who inadvertently received a dose of Fluvirin vaccine on an unreported day in December 2003. On an unspecified day in December 2003, up to 8 vaccinees were inadvertently administered Fluvirin. The outcome of the event was not reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Further information was received from a health care professional indicating that the vaccinee was a 45 month old female who inadvertently received 0.5ml Fluvirin on 1/12/04. No adverse events were reported at the time of the event. No follow up pending. All information received.									U	01/12/2004	01/12/2004	0		UNK	UNK	NONE		NONE		PJP200400174	1						1	Medication error	FLU3~EVANS VACCINES~766048~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231070	12/14/2004		3.0			M	10/08/2004	A report was received from a health care professional on 2/24/04 concerning up to 8 vaccinees under 4 years of age and of unknown gender who inadvertently received a dose of Fluvirin vaccine on an unreported day in December 2003. On an unspecified day in December 2003, up to 8 vaccinees were inadvertently administered Fluvirin. The outcome of the event was not reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Further information was received from a health care professional indicating that the vaccinee was a 47 month old male who inadvertently received 0.5ml Fluvirin on 12/18/03. No adverse event were reported at the time of the event. No follow up pending. All information received.									U	12/18/2003	12/18/2003	0		UNK	UNK	NONE		NONE		PJP200400175	1						1	Medication error	FLU3~EVANS VACCINES~766048~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231071	12/14/2004		65.0			F	10/08/2004	A report was received from a health care professional on 3/22/04 concerning a 65 year old female vaccinee who experienced on 11/21/03 a sore throat, productive cough, and nasal drainage after receiving Fluvirin on 11/12/03. On 11/21/03, the vaccinee experienced a sore throat, productive cough and nasal drainage. The vaccinee recovered from all events on 11/26/03. There was insufficient information to determine the reporter's causality assessment. No follow up pending. All information received.									Y	11/12/2003	11/21/2003	9		UNK	UNK	NONE		NONE		PJP200400177	1						1	Cough; Pharyngolaryngeal pain; Rhinorrhoea	FLU3~EVANS VACCINES~765855~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231072	12/14/2004		3.0	2	.8	F	10/08/2004	A report was received from a health care professional on 12/16/03 concerning a group of 5 vaccinees aged less than 4 years of age and of unknown gender who were inadvertently administered Fluvirin on an unknown date. On an unknown date, a group of 5 vaccinees aged less than 4 years of age and of unknown gender were inadvertently administered Fluvirin. No adverse events have occurred as a result of this at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/26/04: A follow up report was received from a health care professional indicating that a 2 year old female vaccinee inadvertently received 0.25ml Fluvirin on 10/30/03. The vaccinee did not experience any adverse symptoms as a result. Follow up pending.									U	10/30/2003	10/30/2003	0		UNK	UNK	NONE		NONE		PJP200400180	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231073	12/14/2004		4.0	3		M	10/08/2004	A report was received from a health care professional on 12/16/03 concerning a group of 5 vaccinees aged less than 4 years of age and of unknown gender who were inadvertently administered Fluvirin on an unknown date. On an unknown date, a group of 5 vaccinees aged less than 4 years of age and of unknown gender were inadvertently administered Fluvirin. No adverse events have occurred as a result of this at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/26/04: A follow up report was received from a health care professional indicating that a 3 year old male vaccinee inadvertently received 0.5ml Fluvirin on 11/12/03. The vaccinee did not experience any adverse symptoms as a result. Follow up pending.									U	11/12/2003	11/12/2003	0		UNK	UNK	NONE		NONE		PJP200400181	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231074	12/14/2004		3.0	2	.6	F	10/08/2004	A report was received from a health care professional on 12/16/03 concerning a group of 5 vaccinees aged less than 4 years of age and of unknown gender who were inadvertently administered Fluvirin on an unknown date. On an unknown date, a group of 5 vaccinees aged less than 4 years of age and of unknown gender were inadvertently administered Fluvirin. No adverse events have occurred as a result of this at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/26/04: A follow up report was received from a health care professional indicating that a 2 year old male vaccinee inadvertently received 0.25ml Fluvirin on 12/2/03. The vaccinee did not experience any adverse symptoms as a result. Follow up pending.									U	12/02/2003	12/02/2003	0		UNK	UNK	NONE		NONE		PJP200400182	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231075	12/14/2004		3.0	2	.8	F	10/08/2004	A report was received from a health care professional on 12/16/03 concerning a group of 5 vaccinees aged less than 4 years of age and of unknown gender who were inadvertently administered Fluvirin on an unknown date. On an unknown date, a group of 5 vaccinees aged less than 4 years of age and of unknown gender were inadvertently administered Fluvirin. No adverse events have occurred as a result of this at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/26/04: A follow up report was received from a health care professional indicating that a 2 year old female vaccinee inadvertently received 0.25ml Fluvirin on 12/3/03. The vaccinee did not experience any adverse symptoms as a result. Follow up pending.									U	12/03/2003	12/03/2003	0		UNK	UNK	NONE		NONE		PJP200400183	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231077	12/14/2004		1.31	1	.3	F	10/08/2004	A report was received from a health care professional on 12/16/03 concerning a group of 5 vaccinees aged less than 4 years of age and of unknown gender who were inadvertently administered Fluvirin on an unknown date. On an unknown date, a group of 5 vaccinees aged less than 4 years of age and of unknown gender were inadvertently administered Fluvirin. No adverse events have occurred as a result of this at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/26/04: A follow up report was received from a health care professional indicating that a 1 year old female vaccinee experienced fever and cold symptoms one week after inadvertently receiving 0.25ml Fluvirin on 12/2/03. The vaccinee recovered after approximately 4 days. Follow up pending.									Y	12/02/2003	12/02/2003	0		UNK	UNK	NONE		NONE		PJP200400185	1						1	Medication error; Pharyngitis; Pyrexia; Rhinitis	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231078	12/14/2004		82.0	81		F	10/08/2004	A report was received from a health care professional on 3/26/04 concerning an 81 year old female vaccinee who developed an all over body rash except for her face and legs on 11/5/03 after receiving Fluvirin on 11/1/03. On 11/5/03, the vaccinee developed an all over body rash except for her face and legs after receiving Fluvirin on 11/1/03. The patient scratched at the rash creating sores. The patient was treated for scabies and her detergent was changed. At the time of the report the patient had not recovered. There was insufficient information to determine the reporter's causality assessment. Follow up received 8/30/04: Further information was received via our distributor. The vaccinee was treated with hydroxyzine, Lotrisone, and Eucerin. As at 8/11/04, the rash continues. She has an appointment with a dermatologist scheduled for 8/13/04. No additional information is available at this time.									N	11/01/2003	11/01/2003	0		UNK	UNK	Aricept; Citalopram; Lasix; Roxicet; Lorazepam		Alzheimer's; Anxiety		PJP200400186	1						1	Herpes zoster; Rash	FLU3~EVANS VACCINES~765854~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231079	12/14/2004		67.0	67		F	10/08/2004	A report was received from a 67 year old female vaccinee on 6/9/04. The vaccinee's past medical history includes atrial fibrillation, for which she is taking Coumadin 5mg alternating with 7.5mg (start date May 2003) and Calan 240mg (start date unknown). On 12/17/03, the vaccinee received one dose of Fluvirin into the left upper arm. About two days later, she developed cold symptoms with fever and sweating that lasted approximately two weeks. Within four to five days of the cold symptoms developing, she also experienced joint pain with inflammation and warmth on her hand. As the pain gradually subsided, soreness appeared at the same site. The vaccinee stated that the cycle of pain and soreness occurred at one particular part of the body at a time (i.e. one arm then the other arm, but not together) and rotated around different parts of the body. The vaccinee took Tylenol for the pain attacks, but this did not have any effect. The attacks stopped at the end of May 2004. The vaccinee stated that recent laboratory test results of an unknown blood test specific for arthritis showed high levels. She will consult a rheumatologist in the near future. The vaccinee stated that she had previously received influenza vaccines for many years without any problem. The vaccinee consulted a physician regarding the events. The physician did not think the events were related to the Fluvirin injection. Follow up received 7/13/04: Report received from a health care professional stating that this 67 year old female received an influenza vaccination (brand not specified) on 12/17/03 into the left deltoid. The vaccinee developed arthritis pain and soreness in the muscles starting on 1/5/04. The event has not resolved. The vaccinee's history includes allergies to Antivert, Zocor, and Baycol. The vaccinee has not been seen by the reporter in the past 3 months. No further information is expected.									U	12/17/2003	12/19/2003	2		UNK	UNK	Coumadin; Calan		Patient has history of atrial fibrillation. Patient has allergies to Antivert, Zocor, and Baycol.		CVOX200400221	1						1	Arthralgia; Arthritis; Feeling hot; Hyperhidrosis; Pharyngitis; Pyrexia; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0231080	12/14/2004		0.8			M	10/08/2004	A report was received from a health care professional in the USA on 7/5/04 concerning a 10 month old male vaccinee who inadvertently received Fluvirin on 11/6/03. This report was received as follow up and involves a group of 10 children under the age of 4 years who inadvertently received Fluvirin instead of the product approved for pediatric use in the USA. None of the vaccinees experienced any adverse effects. No further information is expected.									U	11/06/2003	11/06/2003	0		UNK	UNK	NONE		NONE		CVOX200400231	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231081	12/14/2004		2.0			F	10/08/2004	A report was received from a healthcare professional in the USA on 7/5/04 concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 11/11/03. This report was received as follow up and involves a group of 10 children under the age of 4 who inadvertently received Fluvirin instead of the product approved for pediatric use in the USA. None of the vaccinees experienced any adverse effects. No further information is expected.									U	11/11/2003	11/11/2003	0		UNK	UNK	NONE		NONE		CVOX200400232	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231082	12/14/2004		2.0			F	10/08/2004	A report was received from a health care professional in the USA on 7/5/04 concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 10/28/03. This report was received as follow up and involves a group of 10 children under the age of 4 who inadvertently received Fluvirin instead of the product approved for pediatric use in the USA. None of the vaccinees experienced any adverse effects. No further information is expected.									U	10/28/2003	10/28/2003	0		UNK	UNK	NONE		NONE		CVOX200400233	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231083	12/14/2004		3.0			F	10/08/2004	A report was received from a healthcare professional in the USA on 7/5/04 concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 10/29/03. This report was received as follow up and involves a group of 10 children under the age of 4 years who inadvertently received Fluvirin instead of the product approved for pediatric use in the USA. None of the vaccinees experienced any adverse effects. No further information is expected.									U	10/29/2003	10/29/2003	0		UNK	UNK	NONE		NONE		CVOX200400234	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231084	12/14/2004		2.0			F	10/08/2004	A report was received from a healthcare professional in the USA on 7/5/04 concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 10/29/03. This report was received as follow up and involves a group of 10 children under the age of 4 years who inadvertently received Fluvirin instead of the product approved for pediatric use in the USA. None of the vaccinees experienced any adverse effects. No further information is expected.									U	10/29/2003	10/29/2003	0		UNK	UNK	NONE		NONE		CVOX200400235	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231085	12/14/2004		1.0			F	10/08/2004	A report was received from a health care professional in the USA on 7/5/04 concerning a 1 year old female vaccinee who inadvertently received Fluvirin on 10/29/03. This report was received as follow up and involves a group of 10 children under the age of 4 years who inadvertently received Fluvirin instead of the product approved for pediatric use in the USA. None of the vaccinees experienced any adverse effects. No further information is expected.									U	10/29/2003	10/29/2003	0		UNK	UNK	NONE		NONE		CVOX20400236	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231086	12/14/2004		1.0			M	10/08/2004	A report was received from a health care professional in the USA on 7/5/04 concerning a 1 year old male vaccinee who inadvertently received Fluvirin on 11/3/03. This report was received as follow up and involves a group of 10 children under the age of 4 years who inadvertently received Fluvirin instead of the product approved for pediatric use in the USA. None of the vaccinees experienced any adverse effects. No further information is expected.									U	11/03/2003	11/03/2003	0		UNK	UNK	NONE		NONE		CVOX200400237	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231087	12/14/2004		1.0			M	10/08/2004	A report was received from a health care professional in the USA on 7/5/04 concerning a 1 year old male vaccinee who inadvertently received Fluvirin on 11/3/03. This report was received as follow up and involves a group of 10 children under the age of 4 years who inadvertently received Fluvirin instead of the product approved for pediatric use in the USA. None of the vaccinees experienced any adverse effects. No further information is expected.									U	11/03/2003	11/03/2003	0		UNK	UNK	NONE		NONE		CVOX200400238	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231088	12/14/2004		1.0			M	10/08/2004	A report was received from a health care professional in the USA on 7/5/04 concerning a 1 year old male vaccinee who inadvertently received Fluvirin on 11/3/03. This report was received as follow up and involves a group of 10 children under the age of 4 years who inadvertently received Fluvirin instead of the product approved for pediatric use in the USA. None of the vaccinees experienced any adverse effects. No further information is expected.									U	11/03/2003	11/03/2003	0		UNK	UNK	NONE		NONE		CVOX200400239	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231092	12/14/2004	AZ	0.99	0	1	F	12/13/2004	From initial information received on 12/9/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that an 11 month old female patient received her first dose of FLUZONE, lot number U1468AA, administered in the left thigh, a dose of MMR, lot number 0313P, administered in the right thigh and a dose of VARIVAX, lot number 1350N, administered in the left thigh on 12/3/04. The routes of administration were not reported. Two days later, on 12/5/04, the patient experienced a febrile seizure. The patient's body temperature at the time of the seizure was unknown as per the reporter. The patient was hospitalized for three days and discharged on 12/8/04. The patient has recovered from this event.				Y	Y	3			Y	12/03/2004	12/05/2004	2		PVT	UNK			The patient has a history of mild upper respiratory infections. She had no illnesses at the time of vaccination.		200403908	1						1	Febrile convulsion	FLU3~SANOFI PASTEUR~U1468AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0313P~UNK~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1350N~UNK~~LL~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0231094	12/14/2004	CA	68.0	67		F		Left arm sore at point of vaccination. Swelling, tenderness, and pain in under left arm lymph nodes. Left teeth very sensitive to cold drinks. During night (3 AM 12/12/03) when awakened to go to bathroom, lost balance, all faculties quit, legs folded. I fell into wall, then regained equilibrium and returned to bed. After in bed, tried to sit up and reach for drink of water; could not. Tried to sit up. Could not. Called 911 and taken to emergency center. 3 episodes after returning home. Discharge Summary received on 1/25/2005 arachnoid cyst and ischemic changes.				Y	Y	2			Y	12/05/2003	12/06/2003	1	Contact hospital for more information.	PUB	UNK		NONE	No problems past 20 years.			1						1	Balance disorder; Cerebral ischaemia; Delirium; Hypersensitivity; Hypokinesia; Injection site pain; Injury; Lymphadenopathy	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0231096	12/14/2004	NY	75.0	75		F	12/07/2004	Developed per pt report, low grade fever, body aches and chills, evening of Dec 1 flu shot remained ill for several days. Did see PCP no influenza testing, given no dx per pt. No meds for this. No dehydration. No hospital visit. X 3days.				Y					Y	12/01/2004	12/01/2004	0	NONE	PUB	UNK		NONE	Non allergies except hayfever			1						1	Chills; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1503AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231097	12/14/2004	NJ	73.0	73		M	12/07/2004	As per pt she received an influenza vaccination at a public clinic on 11/16/2004. She received the shot in her right arm and immediately felt pain. Pain has been constant to date and she has been unable to use her arm for any length of time. No redness or swelling. Follow up 01/25/05: To see physician 02/17/05. Still cannot use arm due to pain.				Y					U	11/16/2004	11/16/2004	0		PUB	PUB		Hx of arthritis				1						1	Injection site pain	FLU3~SANOFI PASTEUR~U1579AA~4~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231098	12/14/2004	FL	56.0	56		F	12/06/2004	Influenza administered at head start school by RN on 11/12/04. On 11/13/04, client observed left deltoid swollen and red (where the injection was administered) and had rashes all over trunk. Was treated by doctor 11/29/04.									Y	11/12/2004	11/13/2004	1		UNK	PUB			History of gastric bypass 1996.			1						1	Injection site erythema; Injection site swelling; Rash	FLU3~SANOFI PASTEUR~U1498AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231099	12/14/2004	OH	27.0	26		F	12/10/2004	Shot given 1PM Wednesday, arm and neck sore Wed. Thursday Left arm shoulder neck stiff and sore. Fri whole neck and shoulder stiff				Y					Y	12/08/2004	12/08/2004	0	UNK	PUB	PUB		NONE	NONE			1						1	Injection site pain; Musculoskeletal stiffness; Neck pain	FLU3~SANOFI PASTEUR~MU1459AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231100	12/14/2004	AL	1.03	1	.0	F	12/08/2004	Swelling and redness at injection site almost immediately after immunizations (MMR)									Y	12/08/2004	12/08/2004	0		PVT	PUB	NONE	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site reaction	FLU3~SANOFI PASTEUR~U1439AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE281AA~4~~LL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~X1189~4~~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1185N~1~~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0588P~1~~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0231101	12/14/2004	IL	1.01	1	.0	F	12/08/2004	Varicella vaccine given SQ left thigh on 11/27/2004. Fever to 101.5 began 12/07/04. Also noted redness and swelling at inj site, non tender, no warmth. 12/08/04 developed 3 erythematous papular lesions on abdomen. Remainder of exam 12/08/04 was normal.									U	11/27/2004	12/07/2004	10	NONE	PVT	PVT	NONE	Mild nasal congestion	NONE			1						1	Injection site erythema; Injection site oedema; Pyrexia; Rash papular; Skin ulcer	FLU3~SANOFI PASTEUR~U1503AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A74398D~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0654B~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0231102	12/14/2004	WI	3.0	3		F	12/09/2004	Softball size red, raised, itching, local reaction below injection site starting next day after injection and lasting 3 days, no intervention necessary.									Y	11/26/2004	11/27/2004	1		PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U1425AA~3~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231103	12/14/2004	WV	72.0	72		F	12/06/2004	Evening of flu inj given c/o sore throat and temp 103 x 1 day.									Y	10/14/2004	10/14/2004	0		PVT	PVT	Zestril, Zyrtec, ASA, Calcium	NONE	HTN, Osteoarthritis, Skin cancer			1						1	Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U1496AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231104	12/14/2004	NV	69.0	68		M	12/08/2004	x12 hours edema in right arm									Y	12/06/2004	12/07/2004	1		PVT	OTH		HTN	Sulfa			1						1	Oedema	FLU3~SANOFI PASTEUR~1518AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0605P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0231123	12/14/2004		2.0	2	.1	M	10/08/2004	A report was received from a health care professional on 12/16/03 concerning a group of 5 vaccinees aged less than 4 years of age and of unknown gender who were inadvertently administered Fluvirin on an unknown date. On an unknown date, a group of 5 vaccinees aged less than 4 years of age and of unknown gender were inadvertently administered Fluvirin. No adverse events have occurred as a result of this at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/26/04: A follow up report was received from a health care professional indicating that a 2 year old female vaccinee inadvertently received 0.25 Fluvirin on 11/5/03. The vaccinee did not experience any adverse symptoms as a result. Follow up pending.									U	11/05/2003	11/05/2003	0		UNK	UNK	NONE		NONE		PJP200400184	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231126	12/14/2004	AZ	69.0	68		F	12/14/2004	When she received vaccine, felt it was a different shot than before.  Started to hurt and progressed to pain in several hours.  Four days later, feels needles in upper arm & pain deep inside, more toward shoulder.  Orthopedic specialist consulted.  He will do MRI if no improvement.									U	12/04/2004	12/04/2004	0		UNK	UNK			Bursitis & tendinitis in shoulder over past month		AZ0409	1						1	Pain; Paraesthesia	FLU3~SANOFI PASTEUR~V1558AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231128	12/14/2004	SC	63.0	62		M	12/14/2004	Severe Hives.... Prednisone 6 days.				Y					Y	12/06/2004	12/06/2004	0		UNK	UNK	Lipitor Altace,Plavix,Asprin	NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1560AB~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231130	12/14/2004		26.0	26		M	12/15/2004	RASH ON LEFT SIDE OF NECK GOING DOWN TO CHEST.				Y					Y	12/08/2004	12/15/2004	7		MIL	MIL						1						1	Rash	FLU3~SANOFI PASTEUR~U1457AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231132	12/14/2004	NY	1.28	1	.3	M	12/14/2004	Fever 103-104 in 24 hours. Treated with Motrin. Febrile seizure 24 hours later (twice) with hospitalization. Follow up 02/07/05: Fever of 102.5, body shaking, no prior history of seizures.				Y	Y	4			Y	12/10/2004	12/11/2004	1	Blood cultures negative; WBC 9.41 K/UL; HB 11.3 g/dl; Platelets 290k/UL; UA negative.	PVT	OTH			Developmental delay (hypotonia, speech delay, etc). Follow up 02/07/05: diagnosed with cerebral palsy at 6 months.			1						1	Febrile convulsion; Pyrexia	DTAP~SANOFI PASTEUR~C1697AA~UNK~~~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1415AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE335AB~UNK~~~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A74404A~UNK~~~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0231133	12/14/2004	CT	1.01	1	.0	F	12/14/2004	2 small vesicles at vaccination site. Rx arm site									Y	11/22/2004	12/10/2004	18		PVT	PVT	NONE	NONE	NONE		CT200407	1						1	Injection site vesicles	FLU3~SANOFI PASTEUR~U1488AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A5756K~4~IM~LA~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0586P~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0231142	12/15/2004	NJ	72.0	71		F	12/14/2004	Patient states developed redness and swelling at injection site within in hours. Spread from left shoulder to left elbow. Painful : had temp 99.6 which she describes a fever for her. Lasted 3 days. 12/14: no redness, no swelling.									Y	12/10/2004	12/10/2004	0		PVT	PVT			Allergic to PCN, Sulfa and bee stings.			1						1	Erythema; Injection site erythema; Injection site swelling; Pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U1488AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1179N~2~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0231143	12/15/2004	AZ	77.0	77		M		11/17/04 Fine; waited for about 3 hours received shot. That night, tired and stayed home. 11/18/04 Didn't feel well, throat swollen, couldn't eat or drink much and was listless. 11/22/04 Went to PCP and saw the PA. Checked out ok and sent home. 11/22/04 Went to ER with same complaints as 11/18/04 and was admitted to hospital with dehydration and swollen throat. Stayed in hospital for 8 days. Was released on 12/1/04 to go home. According to wife, he is still very tired and listless. Doesn't eat much or drink much either. Is currently under the care of a nephrologist and also his PCP. Follow up 03/08/05: Patient's recovery status is unknown.				Y	Y	8			U	11/17/2004	11/18/2004	1	NONE	PUB	PUB	Nexium; Toprol; Mirapex; Antibiotics; Crabetac	NONE	Diabetic; HBP			1						1	Anaemia; Dehydration; Fatigue; Hypomagnesaemia; Listless; Liver function test abnormal; Malaise; Oral intake reduced; Pharyngeal oedema; Renal failure acute	FLU3~SANOFI PASTEUR~U1479AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0231144	12/15/2004	VA	48.0	48		F	12/07/2004	Individual received flu shot at 2:07pm on 12/2/04, at approximately 5:05pm noticed burning sensation in both legs: from upper (inner and outer) thigh areas down to calves. Areas were reddened and sensitive to touch. After 24 hours, burning/ redness subsided, however, legs were still sensitive  to touch.										12/02/2004	12/02/2004	0		UNK	UNK						1						1	Erythema; Skin burning sensation; Tenderness	FLU3~SANOFI PASTEUR~U1555AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231145	12/15/2004	GA	27.0	26		F	11/17/2004	Initial complaint of numbness and tingling of tongue progressed to lips; next complaint was itching in throat, frequent dry coughing and wheezing. Gave Benadryl 25mg PO at 2:05pm. Transported to ER via ambulance, for observation x 1.5hr. Returned to work with no further problems.				Y					Y	11/17/2004	11/17/2004	0		PUB	PUB			Allergy to Demerol ; acute kidney infection		GA04048	1						1	Cough; Hypoaesthesia; Paraesthesia; Pruritus; Wheezing	FLU3~SANOFI PASTEUR~U1555AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231146	12/15/2004	CA	20.0	19		F	12/10/2004	Patient states that immediately after flu shot the area around the injection became swollen and felt bruised. She put warm compress on it. The edema resolved the next morning (around 12 hours later) but the bruised feeling continued. I saw her around 24 hours the injection at son's appointment. Area around injetiion with no erythema/edema from at LUE with no numbness. Denied F/C/N/V/P									U	12/08/2004	12/08/2004	0		PVT	PUB			2 months post partum			1						1	Contusion; Injection site swelling	FLU3~SANOFI PASTEUR~U1556AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231147	12/15/2004	FL	74.0	74		M	12/02/2004	Client had influenza vaccine 11/30/04: by the end of the day right arm was stiff and sore, could not move arm above shoulder height. Arm ++painful, black and blue at injection site. By 12/1/04, the arm was red, hot inflamed. Patient took Aleve and applied ice. By 12/2/04, swelling and redness extended down to elbow. Patient denied fever. Patient was advised to apply ice to site, contact MD.				Y					U	11/30/2004	11/30/2004	0		PUB	PUB	Nasocort, Zyrtec, Pulmnocort, Nexil, Prednisone		Sinus, Asthma			1						1	Erythema; Feeling hot; Injection site reaction; Injection site warmth; Joint range of motion decreased; Musculoskeletal stiffness; Myalgia; Skin discolouration; Swelling	FLU3~SANOFI PASTEUR~U1558AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231168	12/15/2004	CA	22.0	22		M	12/15/2004	Pt. relates awakening to 4 minutes of epistaxis for past two days after nasal vaccine 3 days ago. Exam notes superficial tissues at anterior nasi bialterally. PMHx of epistaxis but not lasting as long. No ASA containing products or OTC/Herbal product consumption.									Y	12/13/2004	12/14/2004	1	None	MIL	MIL	None	None	None			1						1	Epistaxis	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0231170	12/15/2004	CA	58.0	57		F	12/15/2004	I purchased 2 doses of pediatric flu vaccine for a total of $48. Twelve hours after receiving the shots (at midnight that day), I woke up with very congested lungs and I was coughing for about 30 minutes. Later, the cough subsided. Next morning I woke up fine.									Y	12/11/2004	12/11/2004	0		UNK	UNK	I am taking thyroxine (.15 mg a day) daily, Fosamax weekly, and 2 chewable Viactive tablets daily.	none	allergy to Sulfa; osteoarthritis, osteoporosis			1						1	Cough; Medication error; Nasal congestion	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0231171	12/15/2004	GA	39.0	39		F	12/15/2004	Following the vaccine, I had a rapid heart beat for about 24 hours.									Y	11/17/2004				UNK	UNK						1						1	Heart rate increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0231173	12/15/2004	VT	39.0	38		F	12/15/2004	Patient received full dose of FluMist.  She waited 15 minutes without incident and left the clinic area.  Approximately 20 minutes after leaving the clinic area, she returned c/o generalized pruritus, particularly on chest, arms, palms of hands.  Erythema and diffuse papules were present on her chest only, in the lower sternal area extending approximately to mid-clavicular area.  Dorsal thorax, stomach area, extremities negative for rash.  Patient denied all symptoms except pruritus.  Lungs and VS serially assessed over a period of 1/2 hour remained within normal limits (lungs clear, VS WNL).  50mg PO benadryl was administered. Phone consultation with primary care physician resulted in patient being transported to Emergency Dept. where she was assessed and released that day.  Rx was benadryl PRN and prednisone 20mg x 2D. Treated at hospital.									Y	12/09/2004	12/09/2004	0	Unknown--contact hospital.	UNK	UNK	None reported	None reported	None reported			1						1	Erythema; Pruritus	FLUN3~MEDIMMUNE VACCINES, INC.~500339p~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0231176	12/15/2004	WV	69.0	68		F	12/15/2004	BP:161/89 (11/22/2004 07:50)   T:95.7 F [35.4 C] (11/22/2004 07:50)   P:64 (11/22/2004 07:50)   R:20 (11/22/2004 07:50)  Pain: 3 (11/22/2004 07:50) HT:61 in [154.9 cm] (11/14/2003 08:58)    WT:226 lb [102.7 kg] (11/22/2004 07:50)  AGE:68  Allergies:PENICILLIN CLINICAL REMINDER ACTIVITY *Pneumovax: Patient educated about adverse reactions that may occur with pneumonia vaccine to include: Soreness around the vaccination site for up to 1-2 days, Fever, Malaise, Myalgia may occur 6-12 hours after vaccination and can persist for 1-2 days. Patient instructed to remain in waitng room for 20 minutes to be observed for any adverse reactions. Patient given handout on Pneumococcal Vaccine, Injection. Level of Understanding: Good Outpatient Pneumococcal vaccine ordered Patient received pneumo-vac at this encounter. Site: right deltoid Present Illness: This is a 68yo, FEMALE, came  To ER with: pain to the right arm from where she  had an injection of pneumococcal vaccine  earlier today there is a family hx of similar  problems developing in abscesses. In the er she  was treated with gatiflox 400 mg iv and she was  to be discharged. she felt weak and shaky and  she was admitted for observation. Allergies: PENICILLIN  TEMP:  95.7 F [35.4 C] (11/22/2004 07:50) BP:    134/83 (11/22/2004 08:05) RESP:  20 (11/22/2004 07:50) PULSE: 64 (11/22/2004 07:50) PAIN:  3 (11/22/2004 07:50)  Physical exam:General: ambulatory, awake,  alert, oriented x3, Lungs: clear,  Extremities: No edema.  Assessment:  cellulitis        Plan: admit 23 hour recheck cbc Patient's age:  68          Sex:  FEMALE Temp:    98 F [36.7 C] (11/23/2004 06:45) Pulse:   66 (11/23/2004 06:45) B.P.     140/67 (11/23/2004 06:45) Resp.    18 (11/23/2004 06:45) Pain: 0 (11/23/2004 06:45)                        HISTORY - PRESENT ILLNESS Chief Complaint: RIGHT ARM SWELLING History of Present Illness: SHE HAD A PNEUMOCOCCAL VACCINE INJECTION YESTERDAY AND SOON AFTERWARD DEVELOPED PAIN AND SWELLING TO THE RIGHT ARM. THIS KIND OF REACTION HAS OCCURRED BEFORE IN HER AS WELL AS HER SON WHO HAD TO HAVE DRAINS AFTER AN ABSCESS DEVELOPED. SHE WAS TREATED WITH 400 MG IV GATIFLOX IN THE ER AND ADMITTED FOR OBSERVATION AND FOR HOT PACKS TO THE RIGHT ARM. Review of Systems: Repiratory:  NO SHORTNESS OF BREATH, NO COUGH                        PHYSICAL EXAMINATION General Appearance:    Good Heart:  Normal to inspection, palpation, and auscultation.  Sinus rhythm, S1 and S2 normal, no murmurs, gallops, clicks or rubs.   Extremities: THERE IS SWELLING AND TENDERNESS TO THE RIGHT ARM AT THE POSTERIOR ASPECT THE ARE OF INDURATION WHICH IS VERY TENDER TO PALPATION IS 6 INCHES BY 3 INCHES Initial Impression: ACUTE CELLULITIS POST VACCINATION WITH PNEUMO 11/23/2004 ADDENDUM  SHE HAD FLU SHOT TO LEFT ARM AND PNEUMOVAX TO RIGHT ARM YESTERDAY MORNING. SHE HAD PNEUMOVAX 5 YRS AGO WITHOUT PROBLEMS HAD SOME CHILLS YESTERDAY				Y	Y	1			Y	11/22/2004	11/22/2004	0	Discharge Summary received on 1/06/2005 states lab test abnormal.	UNK	UNK	Active Outpatient Medications  1)GATIFLOXACIN 400MG TAB TAKE ONE TABLET BY MOUTH EVERY DAY 2)IBUPROFEN 800MG TAB TAKE ONE TABLET BY MOUTH THREE TIMES A DAY AS NEEDED WITH MEALS - FOR PAIN 3)   OXYCODONE 5MG/ACETAMINOPHEN 325MG TAB TAKE 1 TA	none	1. Hypertension, NOS                                 11/22/04  2. Degenerative Joint Disease                        11/14/03    3. Hyperglycemia                                     11/14/03    4. Hyperlipidemia                                    11/14/03    5. Hemorrhoids                                       11/14/03    6. Hearing loss * (ICD-9-CM 389.9)                   11/14/03    7. INTERMED CORONARY SYND                            06/23/00   8. ESOPHAGEAL REFLUX                                 04/18/00    9. STOMACH FUNCTION DIS NEC                          11/10/99   10. OBESITY, UNSP                                     11/10/99   11. OSTEOARTHROS NOS-UNSPEC                           08/05/99   12. LUMBOSACRAL NEURITIS NOS                          02/03/99    13. AC GASTRITIS W/O HEMORRHAGE                       10/13/97			1						1	Asthenia; Cellulitis; Chills; Injection site abscess; Injection site pain; Laboratory test abnormal; Malaise; Myalgia; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U1527AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0231177	12/15/2004		27.0	27		F	12/15/2004	DEVELOPED PAIN/ITCHY RASH ALL OVER MY STOMACH. RED, BLOTCHY AREAS WITH SCABS FROM BUMPS.				Y					N	12/07/2004	12/07/2004	0		MIL	MIL	DESOGEN (BCP)	NO				1						1	Erythema; Pain; Pruritus; Rash macular	FLU3~SANOFI PASTEUR~U1457AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231180	12/15/2004	CA	10.0	9		M	12/14/2004	See neurologist note. Pt reports affected speech and episode of prolonged dystonic tongue posturing. Non specific paroxysmal spell post receipt of FluMist. Glared over not himself, pursing lips, holding lips square; talking with tongue thrust behind front teeth, problem finding words, involved talking but not eating. Diagnosis: Prolonged dystonic tongue posturing. Problem resolved after about 5 weeks (prior neurology exam).									Y	10/29/2004	11/01/2004	3	Referred for MRI, non Scheduled	OTH	PVT			Prev episode prolonged dystonic tongue posturing 1999 post febrile seizure			1						1	Abnormal behaviour; Dystonia; Speech disorder; Tongue disorder; Condition aggravated; Dyskinesia; Dystonia; Mental impairment	FLUN3~MEDIMMUNE VACCINES, INC.~500335P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500335P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0231194	12/16/2004	NC	0.51	0	.5	M	12/14/2004	After injection of vaccines, patient had redness at all sites. IPV site was the largest. Redness developed within 2-3 minutes, no trouble breathing. Benadryl po given and patient (+mom) stated in clinic 20 minutes. Redness decreased . * Previous injections DTaP, Hib, IPV and PCV given 11/8/04: had redness and Benadryl given. Went away per mom: no problems									Y	12/13/2004	12/13/2004	0		PVT	UNK						1						1	Injection site erythema; Vaccine positive rechallenge	DTAP~SANOFI PASTEUR~U1316DA~3~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1454AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE388AA~3~IM~LL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~X1040~3~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~A575560~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0231195	12/16/2004	CA	69.0	68		F	12/13/2004	12/3/04: 9:15 flu shot given: has had these for many years. 11:30 awakened with itching, welts 'all over , eyes swollen shut, SOB like asthma. No medication allergies. History of bee sting allergy: 12/4/04 0030 to ER given IM Benadryl and Cortisone, then oral Benadryl later . 1 eye still swollen.				Y					Y	12/03/2004	12/03/2004	0		PUB	PUB	Zocor, Hydroclothorachot, Baby aspirin, Benecar		Bee stings; high cholesterol, high blood pressure			1						1	Dyspnoea; Eye swelling; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1556AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231196	12/16/2004	AL	38.0	37		F	12/08/2004	Sick at stomach, whelps, itching, felt like I couldn't breath. Received steroid shot, Benadryl, and breathing treatment at medical center. Took po Benadryl the following day.				Y					Y	12/06/2004	12/06/2004	0		PUB	PUB	Nebulizer, Singulair, Advair, Estrogen		Asthma		AL0428	1						1	Abdominal pain upper; Condition aggravated; Dyspnoea; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1531AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231197	12/16/2004	LA	1.02	1	.0	F	12/10/2004	reaction unevaluable									Y	11/18/2004	12/08/2004	20	light case of chickenpox (rashes)	PVT	PUB						1						1	Dermatitis bullous; Drug ineffective; Laboratory test abnormal; Viral infection	FLU3~SANOFI PASTEUR~U1560AB~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0817N~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A74398C~1~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0651~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0231198	12/16/2004	IL	1.0	1	.0	F	12/07/2004	Difficulty breathing that spontaneously resolved around 12 hours after administration of vaccine. Cellulitis over right lateral thigh noted by mother >24 hours after administration of vaccine. No treatment given since patient is clinically stable, active and smiling in clinic, and per mother, lesion appears to be improving. Recovering.									U	12/07/2004	12/08/2004	1		PVT	PUB						1						1	Cellulitis; Dyspnoea; Skin ulcer	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A007AA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1461BA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0229P~3~IM~LL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~A57561C~3~ID~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0231199	12/16/2004	NY	1.03	1	.0	M	12/09/2004	Fever (T 106.9 F) an rash on trunk, four lesions in mouth occurring 8 days after vaccines around 10-20 lesions on body.				Y					Y	11/30/2004	12/08/2004	8	CBC within normal limits	PUB	UNK						1						1	Aphthous stomatitis; Pyrexia; Rash	FLU3~SANOFI PASTEUR~01439AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0313P~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0649P~1~~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0231207	12/16/2004	CA	36.0	36		F	12/06/2004	Muscle aches, headache, runny nose, fever 102.3.									U	12/03/2004	12/05/2004	2		PUB	PUB					CA040079	1						1	Headache; Myalgia; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500338P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0231208	12/16/2004		20.0			F	12/16/2004	Patient is 20-year-old female who received typhoid vaccination and influenza vaccine on the 14th of December 2004.   She reports doing well following the vaccination without any unusual reactions.  She reports going to work and doing typical paper work with no unusual exposures.  She reports getting the vaccine at approximately 1500 and then she went to work for the night.  She noticed at the end of her shift that her fingers were swollen and that her feet were swollen.  She had a rash in the folds of her arms that she described as lines.  She had a rash on her feet.  The soles felt tingling and her toes were sensitivity.  The tops of her feet were red.  No hives.  The rash was very sensitive but not really pruritic.  The rash was present for approximately 24 hours.  No other symptoms:  no shortness of breath or difficulty breathing.  No dizziness or lightheadedness.   She reports possible fever and chills when sleep because she woke up in a sweat.  She reports occasional cough.  No other recent illness and denies sore throat.  No sick contacts.   No history of food allergies as a child.  No problems with eggs and she can eat eggs on a regular basis.  She went to the emergency room yesterday and was treated with ibuprofen and kenalog cream.  The symptoms seem to have improved.  No joint aches or knee or back pain.				Y					Y	12/14/2004	12/15/2004	1	None	MIL	MIL	No other medications	Not ill at the time of the vaccine.	None			1						1	Chills; Night sweats; Oedema peripheral; Paraesthesia; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U1457AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~SANOFI PASTEUR~X0850~1~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0231209	12/16/2004	NY	44.0	44		F	12/16/2004	Patient received vaccine on 12/15/04 @ 7pm. Sometime after 10:30pm on 12/15/04 patient awoke from her sleep.  Patient was coughing, wheezing, and having difficulty breathing.  Patient experienced a feeling of a heavy weight on her chest.  The episode of breathing difficulty lasted approx. 2-3 hours, patient was unable to sleep during this time.									U	12/15/2004	12/15/2004	0		UNK	UNK	allegra D, prozac, insulin, enalapril maleate	none.	diabetes mellitus			1						1	Chest pain; Cough; Dyspnoea; Sleep disorder; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0231212	12/16/2004	CA	47.0	46		F	12/16/2004	Immediately following vaccination client developed itching at the site and it spread to a generalized itching from the waist up.  She had tinglinig in her lips as well.  She developed a baseball sized area at the injection site that was red and hot and lasted about four days.  The reaction required OTC Benadryl be taken at the time and again later that evening, as well as once the following day.									Y	12/08/2004	12/08/2004	0	None	UNK	UNK	Thyroid medication and Hydrodiuril	None	Drug reaction to Axid			1						1	Injection site erythema; Injection site hypersensitivity; Injection site warmth; Paraesthesia; Pruritus	FLU3~SANOFI PASTEUR~U1556AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231213	12/16/2004	SD	32.0	32		F	12/16/2004	Profound weakness, unusual sleeping and awakening tired.  Orthostatic dizziness.  Chest tightness.  No Cough, history of asthma.  No sneezing No OTC medications.				Y					U	12/13/2004	12/14/2004	1	WBC 9600 21.2% lymphs  72% Grans.   HB 14.8 Platelets 315,000	UNK	UNK	None	No	Hypothyroidism, 2 years previously. Not on treatment, No classical symptoms of hypothyroidism.			1						1	Asthenia; Chest discomfort; Dizziness; Fatigue; Laboratory test abnormal; Sleep disorder	FLUN3~MEDIMMUNE VACCINES, INC.~5003536P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0231215	12/16/2004		23.0	23		M	12/16/2004	Developed itching in right arm that he received shot in. Then developed raised pruritic erythematous maculopapular rash over right hand and wrist. Pt also had rt eyelid swelling and itching.				Y					Y	12/10/2004	12/10/2004	0		MIL	MIL	NO	NO				1						1	Eyelid oedema; Pruritus; Rash erythematous; Rash maculo-papular	FLU3~SANOFI PASTEUR~U1457AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231216	12/16/2004		23.0	23		M	12/17/2004	Pt noted two new skin lesions near vaccination site.  Vesicular in appearance.  Erythematous. Denies fever, H/A, CP.									U	12/14/2004	12/17/2004	3	None	MIL	MIL	None	None	Denies			1						1	Erythema; Injection site vesicles; Skin ulcer	FLU3~SANOFI PASTEUR~U1457AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~~1~ID~RA~SMALLPOX (DRYVAX)~1	USA		Influenza
0231222	12/16/2004	NY	17.0	17		F	12/16/2004	Patient received vaccine 12/7/04 am. Developed swelling and redness right arm around injection site that evening. Went to ER and placed on Keflex. Then on 12/8 area getting bigger went to walk in clinic Keflex. Discharged , prednisone started.				Y					U	12/07/2004	12/07/2004	0		PUB	UNK	Zyrtec, Zantac, MTV, Celebrex, Folic Acid, Calcium	gastritis, asthma, RA	Allergy, Amoxicillin			1						1	Injection site erythema; Swelling	FLU3~SANOFI PASTEUR~U152AAB~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0529P~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0231223	12/16/2004	PA	59.0	58		F	12/16/2004	Received flu vaccine 12/8/04: noticed swelling under left arm pit on 12/11/04. Denies fever, no redness or induration. Was evaluated by PMD 12/14/04and instructed to apply ice packs and continue ibuprofen. Patient called health department 12/10/04 to report: swelling now subsided. Never had pervious reaction to flu shots before.									Y	12/08/2004	12/11/2004	3		PUB	PVT			Asthma			1						1	Lymphadenopathy; Swelling	FLU3~SANOFI PASTEUR~U152AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231224	12/16/2004	KY	57.0	57		M	12/16/2004	Rash on arms, chest and legs. Itches started Wednesday 12/15/04. Had flu shot 12/13/04. Had cardiac cath 12/9/04. No new meds except Benadryl since rash and itching developed. Doctor told him to take Benadryl and report incident to health department.									N	12/13/2004	12/15/2004	2		PUB	PUB	Ferrous Sulfat, Lenoxin, Coreg, Lasix, Humolog Insulin, Humulin Insulin, Zaroxaly, baby  ASA	Heart disease,diabetes	allergy: Tricor and lescol and reaction to ? blood thinner			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U1531AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231233	12/17/2004	VA	73.0	73		M	12/17/2004	Flu vaccine given 11/17/04.  Developed rash over most of body on 11/19/04. Pt received Enbrel injections on 11/18/04 and 11/26/04.  On 11/19/04, physician diagnosed pt with Erythema Multiforme and treated with Valacyclovir HCl 1 po bid X 1 wk. Follow up on 12/3/04 revealed Erythema Multiforme Improved.  Pt moved from area a few days later and has been lost to further follow up.				Y					Y	11/17/2004	11/19/2004	2		UNK	UNK	Enbrel injections twice weekly	None	none			1						1	Erythema multiforme; Rash	FLU3~SANOFI PASTEUR~U1528AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231234	12/17/2004	VA	69.0	68		M	12/17/2004	Pneumococcal vaccine given SQ in left arm on 12/7/04. On 12/8, pt reported to nurse that he was experiencing pain, redness, and severe swelling from injection site to fingers.  Examined by MD on 12/8/04 and treated for cellulitis with Amoxicillin/Clav 500 mg bid X 10 days.  Pt reported some improvement on 12/9.  Per MD office on 12-17-04, cellulitis completely resolved.				Y					Y	12/07/2004	12/07/2004	0		UNK	UNK						1						1	Cellulitis; Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1528AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0490P~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0231235	12/17/2004	NY	20.0	20		F	12/17/2004	Telephone call from employee, stating she was diagnosed with Guillian-Barre Syndrome. Unclear if related to Influenza Vaccine or not. States prior to vaccine c/o sore throat and earache on 10/26/04- Saw PMD, temp 99-100F. Started on Amoxicillan. 10/28/04 c/o hands and toes tingling. Received Influenza vaccine on 11/2/04. Admits to only telling administering nurse that she was on an antibiotic for cold s/s but denied an elevated temp. Did not tell nurse about neurological symptoms. 11/3 stated rt side of face paralyzed. 11/4 c/o feet slapping. Saw neurologist. States had MRI 11/5- reported no stroke or tumors. 11/8 Saw neuro again- c/o falling with ambulation. States had no ankle reflexes and admitted to hospital. Had spinal tap and dx with GBS. Currently at home, slowly improving with home PT.   01/12/05 Discharge summary 0f 11/8-11/15/2004 gives final diagnosis as Guillain-Barre syndrome, CMV (+), Depression. Treated with IVIG, antivirals for CMV(+) & PT resulting with ability to walk w/walker on d/c.  H&P states sore throat 'two weeks ago' (about 10/25/04) went home from office visit to Dr and 'had tingling in her face and hands'.  The tingling continured thru 11/02 when she got the flu shot. Next morning she had rt side of face numbness and drooping and  weakness in feet and legs, worse on the rt than left.' Neuro consult obtained. 01/26/05 From nursing supervisor that patient had at least one previous flu vax in 02.					Y	8			U	11/02/2004			LABS: elevated LFTs, Epstein-Barr Ab IgM positive, CMV positive at 1.76, CSF protein 67(H), negative for Oligoclonal bands.  Chest film neg, normal EKG.	UNK	UNK	unknown	Reported earache, sore throat and tingling in hands and toes, temp 99-100 on 10/26 but did not report this to vaccinating nurse	Medical Records received on 2/02/2005 states migraine.			1						1	Depression; Facial palsy; Fall; Guillain-Barre syndrome	FLU3~SANOFI PASTEUR~U1421AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0231245	12/17/2004	NY	63.0	63		M	12/17/2004	Patient admitted to hospital with ascending polyneuropathy consistent with Guillain Barre Syndrome. Symptoms worsened, given IVIG and he was transferred to tertiary care center for plasmapheresis. Symptoms began one hour after vaccine. He had URI 2 weeks prior to symptoms.   1/3/2005  Hospital d/c summary of 12/8-12/9/2004 states GBS, urinary retention & weakness.  Neuro consult done.  Pt had recent URI.  Admitted to ICU & tx w/IVIG initially.  Transferred to higher level of care.  2/02/2005 Hospital d/c summary of 12/9-12/15/2004 FINAL DX: GBS, Miller Fisher variant Records states pt experienced numbness of hands & feet within 2 hrs of vaccination on 12/7, weakness, difficulty walking, urinary retention, ataxia & constipation. Neuro consult & LP done.  Exam revealed marked ataxia.  Transferred to inptient rehab.  Follow up 03/01/05: The patient has not recovered from the events, has presistant ataxia and gait instability and neuropathic pain. As per annual follow up 01/04/2006 Some improvement, peripheral neuropathy of hands and feet. Trouble with gait and urinary retention. Some neuropathic pain.					Y	8			N	12/07/2004	12/07/2004	0	CSF tests WNL.  EMG/NCS revealed no acute changes.	PVT	PVT		URI 2 weeks prior. Medical Record received on 1/3/2005 states cough and nasal congestion. Discharge Summary received on 2/02/2005 states URI/cold.	PMH: c-spine stenosis & surgery w/right arm weakness & atrophy post op; rapid a-fib; mitral valve repair; HTN; hypercholesterol.  Allergy: PCN, other meds.			1						1	Asthenia; Constipation; Coordination abnormal; Gait disturbance; Guillain-Barre syndrome; Neuropathy; Pain; Polyneuropathy; Urinary retention	FLU3~SANOFI PASTEUR~U1503AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0231246	12/17/2004	IL	48.0	48		F	12/16/2004	Patient has a history of metastatic uterine leiomyosarcoma treated with chemotherapy (most recently thalidomide), radiation, hepatic chemoembolization and recent back surgery. One day after receiving a flu vaccine, patient developed fevers to 103 degrees F, nausea/vomiting, fatigue and pain and weakness in the proximal legs. Renal function also deteriorated and hemoglobin dropped (see lab results below) requiring a three day hospital admission for blood transfusion and treatment of dehydration and leg pain. Medical Record received on 1/12/2005 states mouth ulcers, wheezes, diarrhea, and cough.					Y	3			Y	11/28/2004	11/29/2004	1	Blood oxygen; UCx: no growth.	OTH	OTH	Atenolol; Darvocet; Motrin; Valium; Biaxin; Thalidomide	NONE	PCN; Keflex; Levaquin; Uterine leiomyosarcoma			1						1	Anaemia; Cough; Dehydration; Diarrhoea; Fatigue; Laboratory test abnormal; Mouth ulceration; Muscular weakness; Nausea; Pain; Pyrexia; Renal impairment; Vomiting; Wheezing	FLU3~SANOFI PASTEUR~U14580AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0231248	12/17/2004	CA	2.0	2	.2	F	12/17/2004	Actual physical exam as not done. Patient presents to urgent care for COs adverse reaction. FOLLOW UP: 12/19/04 RN at facility of vaccination reported that reaction was bright red inflammed area on left thigh. Apparently not related to flu vaccine since DTaP was given at that site. Reaction was on left thigh (DTaP) site. Follow up 01/19/05: Unkown time and date of adversevent, mother of child did not follow up with reporter.				Y					U	12/14/2004	12/16/2004	2		PUB	PUB						1						1	Injection site erythema; Injection site inflammation; Injection site reaction; Unevaluable event	DTAP~SANOFI PASTEUR~U1343BA~4~~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1467AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231249	12/17/2004	IN	49.0	49		F	12/17/2004	Arm pain since vaccination was administered intermittent joint pain with in 1 day hands, knees, fingers. No arm pain after injection until approximately 4 days later.				Y					N	10/21/2004	10/25/2004	4		PUB	PVT	Toprol, Topamax, ASA	NONE	Codeine, Sulfa, Keflex			1						1	Arthralgia; Pain	FLU3~SANOFI PASTEUR~U1454AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231250	12/17/2004	PA	47.0	46		M	12/17/2004	Dizziness, Difficulty walking secondary to above									U	12/15/2004	12/17/2004	2		PVT	PVT	NONE	NONE	NONE			1						1	Difficulty in walking; Dizziness	FLUN3~MEDIMMUNE VACCINES, INC.~500338P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0231251	12/17/2004	MS	44.0	44		F	12/15/2004	Generalized rash over arms and legs itching and slight edema around mouth. Sent to ED MD and given epinephrine and prednisone pack. Released. On date of report to employee health, denied any symptoms.				Y					Y	12/13/2004	12/13/2004	0		PUB	UNK			Blue-berries			1						1	Face oedema; Pruritus; Rash	FLU3~SANOFI PASTEUR~U1508AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231252	12/17/2004	OH	54.0	54		F	12/07/2004	Large local allergic reaction (hives and swelling) adjacent to site. No history of allergy to eggs or antibiotics. Given prednisone and Benadryl.				Y					Y	12/03/2004	12/05/2004	2		PVT	PVT	only med is Coumadin		breast cancer			1						1	Hypersensitivity; Swelling; Urticaria	FLU3~SANOFI PASTEUR~U1516AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231253	12/17/2004	SD	55.0	54		M	12/09/2004	Disorientation while at post office, sudden headache and some difficulty seeing. He stated he was seeing spots with more difficulty from right eye. Medical Record received on 1/06/2005 states hypercholesteremia.				Y					Y	12/07/2004	12/07/2004	0		UNK	PVT						1						1	Disorientation; Headache; Hypercholesterolaemia; Visual disturbance	FLU3~SANOFI PASTEUR~U1558AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231255	12/17/2004	OH	44.0	44		F	12/14/2004	Doctor's office 12/14/04 : states infected. Advil: warm compresses, red, hot arm. No temperature.				Y					Y	12/13/2004	12/14/2004	1		PUB	UNK						1						1	Erythema; Feeling hot; Infection	FLU3~SANOFI PASTEUR~U1532AA~UNK~ID~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231256	12/17/2004	MI	52.0	51		M	12/06/2004	Weakness on the right side of his body. Touch makes right side of body sweat. Numbness in belly area. Loss of use of right hand. Pt is right handed.									U	10/27/2003	11/01/2003	5	CT Scan of head has been done and has been normal. Blood testing, including LFT has been normal. Calcium level is normal. CBC is normal. ESR was 15. Uric acid was normal. Rheumatoid factor was negative. RPR was negative. Mono test was negative. PSA was normal. CA was negative. Hemoglobin Aic is in good range at 6.0. Urinalysis was normal. ANA was negative. Serum protein electrophoresis was normal. D-dimer was negative. LDL showed a cholesterol of 126, triglycerides of 253. Vitamin B-12 and folic acid levels were normal. TSH and T4 were normal. ASO titer was negative. CK was normal. Prolactin level is normal.	MIL	MIL	Zervac, Glucophage, Tylenol, Zocor 210mg, Topiramate 25bid, Venlafaxine 1 bid.	NONE	Diabetic, antibiotics, hypercholesteremia, reflux, seizures.			1						1	Hemiparesis; Hyperhidrosis; Hypoaesthesia; Paralysis	FLU3~SANOFI PASTEUR~U1138AA~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231257	12/17/2004	PA	79.0	79		F	11/22/2004	Client called on 11/22/2004 requesting to know the type of vaccine administered to her on 11/19/04. Client reports that she developed a rash covering her entire body following administration of vaccine. Instructed client to see family physician client reports that she is going to contact family physician. 11/29/04 TC: pt reports that she is taking prednisone, saw physician and rash is resolving.				Y					Y	11/19/2004	11/19/2004	0		PUB	UNK		NONE	NONE			1						1	Rash	FLU3~SANOFI PASTEUR~U1527AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231236	12/19/2004		0.0			U	12/19/2004	Due to confidentialty, I cannot give the patients name, I will forward to you my findings or concerns that could help you to understand whether or not the flu/pneumonia vaccine or Hepatitis B shots has adverse reations. The patient was not on any medicines at the time, therefore indication is that it was either of these vaccines. The patient had been removed or medicine was on as needed basis, at least 6 weeks prior to this lab resuts: While on other bio-genetically engineered meds, the patients lab results was way above the ESRD & normal range (in the 290's+), After the these meds were either removed or was reduced to as needed (about once a week instead of daily) the results dropped within the 89 (close to the ESRD), This was in lets say Month of October, the following month November, the patient  did not take the once a week med, this time (ofcourse the patients Asthma now improved, meaning her breathing improved, the peak flow data showed all the improvement.  However around mid October the patient went & received the usual flu & pneumonia vaccine, & remember no other medicines , (possible also Hepatitis B, I do not have that information currently, noticed your website..etc.) in November 1 month after the flu/pneumonia vaccine, the patients PTH jumped to 291. I suggest that you can easily do a before & after lab tests on patients on any of these vaccines or meds.  These tests should be given to young children or anyone receiving these meds & vaccine manufactured under the bio-genetically engineered Frame.  For this patient the parathyroid hormone was effected to my knowledge. Many of these meds if not all are hormone based which is a concern, it works in the short run, in the long run it adds furher illness, serious illness. We were lucky that we chose to work with our doctors & staff in finding the cause of all the illnesses. As far as how the patient is feeling, this years flu/pneumonia vaccine was more painful, it lasted 3 days (72 hours)(October 2004), the patient did have a fever afterwards, 2 months after the concern is that what she developed from having had to many medicines with side effects, was returning a few days a go, even the medicines that helped to cure the side effects has now been removed & it is on the list of medicines that may cause addtional side effects past 60 days of use.  For now we will go with the help of time & just plain eating nutritional foods.  When the FDA made it easier for the medicines to enter the market, they forgot to ask the manufacturer to make a test for every patient receiving these new meds, like the bio-intact PTH test or something that tells the doctor that the patients system is still within the normal or ESRD range.  I feel sorry for the old & the young who are unable to communicate, because once on these medicines how does one know or understand (I know the doctor provided the list of possible side effects sheet), if the side effect is happening or is it one waits for the worse case to happen.  I give this information so that you can help, I only ask that if the test available a manufacturer be chosen who will make it so that it is affordable to every person, not just the ones with insurance, because if you have 4 kids x $20.00 a shot is $80 that a parent with no insurance or a deductible could not afford, so I can count what it will cost when one has to test to make sure of adverse reactions.  Please note the patient I am speaking about refused in 99 % of the time to run to the doctor until the ambulance was required, the patient could not find the words to say that this is the worst medicines & the patient required the asthma medicines & the blood pressure medicines until one day got enough courage to say no & a helper who out of fear stayed with the patient 24 hours a day, watching for any changes & monitoring the patients breathing, which as I indicated to our surprise started to improve after the holding of the maintenance meds. The blood pressure improved also  I want you to understand that if a child says mommy this shot hurts, than 24 hours later the pain went away, but the vaccine is in the body for the remainder of the year, with no system in place in the event of a serious side effect nor a test to detect the side effect. How will an elderly on other meds & a child explain the medical terminology needed to explain what could be happening?  The other alternative is to develop vaccines that are no more than 30 days & see if they have adverse reaction or certainly no more than a 3 month vaccine. Bio-genetic is still new.   This patient got lucky, when the doctors & staff were willing to listern to the patient's family & worked towards removing the meds & it helped when the patients family volunteered to stay with the patient during this time.  The chances are zero as I look around & see the elderly & the working parents who can hardly afford the day care.  The best thing is to recruit all the future doctors & nurses & staff as volunteers in your community to help with the elderly other than waiting for that once a year doctors visits, taking their blood pressure daily, that is when our nations healthcare system will improve & so will the healthcare providers knowledge.  I say this is important enough to be in part of the education system.  Some tests for these meds are now in place as I have noticed on the lab sheets. I hope every hospital does this for their patients.  December 19, 2004  Last but most importantly, I ask that you post the list of the contents in the vaccine & other medicines.  A drug allergic test or allergy test than can easily indicate if the patient is already allergic to the chemical in it. Some patients already know some of their allergies, however if it states clearly in the insert than one can atlease alert their doctor. Why put the patient through the toughest search. The FDA makes sure that the food contents be listed, why isnt the medicines content listed? Aren't the manufacturers of the medicines in business to save lives? Well I am not a doctor or a nurse or a staff in the medical profession, I am just someone who had enough basic understanding that if the patient did not have all these illness when they were born than why at this old age & than we went to work to help the patient get well again.     Good luck, I hope this helps									U					UNK	UNK						1						1	Asthma; Dyspnoea; Laboratory test abnormal; Pain; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~HEP B (ENGERIX-B)~1	USA		Influenza
0227018	12/20/2004	KS	31.0	30		F		A report was received from a healthcare professional in the USA on 12/8/04 concerning a 30 year old female vaccinee. The vaccinees past medical history includes severe allergies to food, including eggs, wheat and corn. However on the patient's consent for influenza vaccine administration, it is documented that the vaccinee does not have allergies to eggs, chicken feathers, chicken dander, mercury or thimerosal. In addition, the vaccinee does not have severe latex sensitivity and did not have an acute illness with fever at the time of vaccination. The vaccinee did not receive an influenza vaccine during the previous season and she did not have a fever within 24 hours prior to vaccination. The vaccinees concomitant medication at the time of vaccination includes Albuterol, Aerobid, Biaxin, Zithromax, and antibiotics (unspecified). On approximately 12/18/03, the vaccinee received a single dose of Fluvirin (batch 765796) in the right deltoid. On approximately 12/24/03, the vaccinee developed severe congestion, shortness of breath, difficulty breathing (which were all thought to be due to a chest cold on 12/26/03), constipation and chronic fatigue. The vaccinee attended the emergency room on multiple occasions, but was never admitted to hospital. The vaccinee was treated with unspecified IV antioxidant treatments. The vaccinee underwent a thorough evaluation including an electrocardiogram and a chest x-ray which showed bibasilar atelectasis and infiltrates. Blood work included D. dimmer and arterial blood gases, but no results were provided. The vaccinee was seen by a pulmonary consultant and it was felt that she has a respiratory infection, as well as a history of asthma. The vaccinee was last seen by the pulmonologist on 3/1/04, when she was felt to have bronchial asthma, cough and allergic rhino-sinusitis. Chest x-ray demonstrated congestion, but was better than the last one and CT scan of the chest on 3/15/04 was normal. PA chest x-ray on 3/4/04 demonstrated atelectasis and a C-spine x-ray on an unspecified date demonstrated soft tissue swelling. It was not reported whether the vaccinee has recovered from these events. No information was provided regarding the reporter's assessment of causality between the events reported and the vaccination with Fluvirin. No further information is expected.									U	12/18/2003	12/24/2003	6	Arterial Blood gases; C-spine x-ray; CAT scan; Chest x-ray; CT Scan of chest; D. dimmer; Electrocardiogram	UNK	UNK	Albuterol; Aerobid; Biaxin; Zithromax; Antibiotics		The patient reports severe allergies to food, including eggs, wheat and corn. The patient is also thought to have a history of asthma.		CVOX200400357	1						2	Asthma; Atelectasis; Constipation; Cough; Dyspnoea; Fatigue; Rhinitis allergic; Upper respiratory tract infection; Atelectasis; Condition aggravated; Constipation; Cough; Dyspnoea; Fatigue; Lung disorder; Nasal congestion; Oedema; Respiratory tract infection; Sinusitis	FLU3~EVANS VACCINES~765796~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~EVANS VACCINES~765796~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0231269	12/20/2004	OR	92.0	92		F	12/10/2004	Resident with toileting. Observed by staff to become nonresponsive, slumped off toilet two times. Body lift and then to bed. Respirations shallow and significant decreased with decreased ausultated lungs followed by pulse drop to 30-40 BPM. Then no BP. Then no pulse and no respiration. Resident deceased. Attempted CPR and oxygen. Death Certificate received on 12/29/2004 states COD is ASHD.	Y	12/10/2004							N	12/09/2004	12/10/2004	1		OTH	OTH	Norvasc; Lisinopril; Impur; Cipro; Aspirin;	NONE	Anemic; CVA		OR200442	1						1	Apnoea; Arteriosclerosis; Bradycardia; Coma; Pulse absent; Respiratory rate decreased	FLU3~SANOFI PASTEUR~U1556AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0231273	12/20/2004	OR	45.0	45		F	12/14/2004	This is not a serious spontaneous case from a nurse in the USA of itching eyes. The reporter causality is not provided to FluMist. This case is submitted according to the VAERS reporting agreement for FluMist. This case is a spontaneous case report sent by a nurse that refers to a female aged 45 years. The patient's past medical history included allergies to grass and cats. She received FluMist on 11/29/04 at 8:20 in the morning. The patient's concomitant medication included Brompheniramine/Pseudoephedrine and Levothyroxine. By the afternoon of 11/29/04, the patient had a runny nose and some sneezing. The events continued through the night and the next morning. On the afternoon of 11/30/04, the events became worse. The patient was constantly sneezing and her nose was running like a faucet. By 6:00 that evening the patient was totally incapacitated. The runny nose and sneezing did not stop until 11:00 that evening. The reporter stated the patient's eyes had some itching and irritation, but mostly the patient's nose was itchy and irritated. The events continued into the following day, but to a lesser degree. The patient was mostly tired for the reaction from the previous 2 days. The reporter stated the patient felt perfect by the fourth day.									U	11/29/2004	11/29/2004	0	NONE	OTH	PVT	Bromfenex SA; Synthroid	Multiple allergies.	Allergies to grass and cats.		MEDI0002524	1						1	Eye irritation; Rhinorrhoea; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~500339P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0231274	12/20/2004	PA	71.0	70		M	12/20/2004	Persistent proximal muscle ache. Sleep disturbance, fatigue, pervasive uterine temporarily, Ibuprofen, Tylenol, Destinez Lt3									N	10/22/2004	10/24/2004	2	CBC, Blood chemistry, SED rate, All normal	PVT	PVT	Altz 25gf, ASA tid	NONE	Allergy-sulfa			1						1	Fatigue; Myalgia; Sleep disorder; Uterine disorder	FLU3~SANOFI PASTEUR~U1457AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231278	12/20/2004	IA	2.0	2	.0	M	12/14/2004	Between 5 and 10 min following injection break out in pruritic red rash. Face, head and few on chest, Benadryl given rash gradually left.									Y	11/05/2004	11/05/2004	0		OTH	OTH		NONE	NONE			1						1	Erythema; Rash pruritic	FLU3~SANOFI PASTEUR~U1476AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231279	12/20/2004	MN	65.0	65		F	12/13/2004	Left arm had swelling the size of an orange (at site of subq injection) by evening went to ER when tongue and eyelids felt swollen and tingly. Arm became progressively more swollen over next 2 days despite having received a cortisone shot and tapering Prednisone dose as well as liquid Benadryl. Swelling gradually resolved.				Y					Y	11/19/2004	11/19/2004	0		PUB	PUB	Atenolol, Trazodone, Protonix, Ursodiol, Celexa, Zetia, Calcium, Baby ASA	NONE	Liver disease, primary biliary sclerosis, allergic to penicillin and sulfa			1						1	Eyelid oedema; Injection site oedema; Paraesthesia; Tongue oedema	FLU3~SANOFI PASTEUR~U1579AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0869N~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0231281	12/20/2004	MN	66.0	65		F	12/13/2004	1st night arm felt like it was going to burn off. 3x3 red, swollen area formed at site of subq injection (pneumonia). Next day-muscles weak in arm, could hardly pick up cup, no pain but didn't feel well, afebrile. That night woke up in drenching sweat like a fever had broke although I had no temp. Felt fine the next day.									Y	11/19/2004	11/19/2004	0		PUB	PUB	HRT, Vitamins, Glucosamine	NONE	Arthritis			1						1	Hyperhidrosis; Injection site oedema; Injection site reaction; Malaise; Muscular weakness; Skin burning sensation	FLU3~SANOFI PASTEUR~U1579AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0869N~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0231282	12/20/2004	IL	4.0	4		F	12/09/2004	Developed erythema and induration at vaccine site.									U	12/07/2004	12/08/2004	1	NONE	PVT	UNK		Asthma, URI	Asthma			1						1	Erythema; Injection site mass	DTAP~GLAXOSMITHKLINE BIOLOGICALS~A639B2~UNK~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1527AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1006~UNK~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0854P~UNK~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0231283	12/20/2004	MI	82.0	81		F	11/01/2004	Received flu shot 10/25/04 in am. 10/26/04 am went to a previously scheduled Dr visit Dr suggested she try Flaxseed-to reduce cholesterol. Tried Flaxseed on 10/26/04 for dinner. 10/27/04 awoke with hives, redness, itching on face and neck. Follow up with private physician 10/27/04 regarding symptoms. Dr put her on Zyrtec daily for 10 days. Began taking Zyrtec immediately. As of 11/1/04 symptoms decreased but continued. 11/3/04 follow up call finds client with continued redness of face and swelling of neck and prickling feeling in throat and neck area. Plans to follow up with own Dr or specialist. 11/29/04 was received by Dr on 11/2/04 recommended f/u TC which was done. Also recommended client f/u with PP re symptoms if continued. See above client plans to do same. Report mailed.									N	10/25/2004	10/27/2004	2	NONE	PUB	PVT	Flaxseed		Allergies: PCN, Cortizone, sensitive to cholesterol med			1						1	Erythema; Paraesthesia; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1478AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231284	12/20/2004	NY	3.0	2	1	M	12/16/2004	20 minutes after vaccine, patient became tired, mottled, Temp >102F. Resolved with Motrin and Benadryl. Temp still present after 12 hours. Still with fever after 12 hours.									U	12/15/2004	12/15/2004	0		PVT	PVT						1						1	Fatigue; Livedo reticularis; Pyrexia	FLU3~SANOFI PASTEUR~U1442AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231285	12/20/2004	MS	1.12	1	.1	M	12/15/2004	At 7:30 PM 7 hrs after shot fever 103.8. Eyes rolled back fully, foaming, 1 min and 5 min post ictal. Went to ER. UA positive, CXR negative. WBC increased 21000, Got Rocephin and Tylenol/ Motrin. At 5am 12/15/04 fever 104.3 jerking and eyes rolling.				Y					Y	12/14/2004	12/14/2004	0	WBC increased 21000, negative CXR, Negative UA	PVT	PUB	Singulair	Diarrhea				1						1	Convulsion; Dyskinesia; Gaze palsy; Postictal state; Pyrexia; White blood cell count increased	DTAP~SANOFI PASTEUR~C1996AA~3~~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1449AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0128P~3~~RA~HIB + HEP B (COMVAX)~1	USA	Emergency room visit	Influenza
0231319	12/20/2004	IL	0.82	0	.8	M	12/20/2004	45 min. post vx baby became irritable and felt warm. Next day in afternoon, fever of 105. Went to E.R. who said symptoms related to an infection, not the flu shot.				Y					Y	11/18/2004	11/19/2004	1		UNK	UNK			Born prematurely		IL04016	1						1	Feeling hot; Infection; Irritability; Pyrexia	FLU3~SANOFI PASTEUR~U1439AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231320	12/20/2004	AR	63.0	62		F	12/20/2004	Hoarseness within 16 hours of injection, dizziness, weakness. These symptoms continue and I have a doctor's appointment tomorrow.									U	12/16/2004	12/17/2004	1		UNK	UNK	Neurontin 800 mg, Trazadone 100 mg, Zanaflex 4 mg, Diovan HTC 160/12.5 mg, Adalat CC 30 mg,  Fosomax 70 mg weekly, Glucosamine 750 mg with Chrondroitin 600 mg.	None	Migraine Headaches, Fibromyalgia, Osteoporosis			1						1	Asthenia; Dizziness; Dysphonia	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0229658	12/21/2004	PA	33.0	33		F	11/26/2004	Posterior cervical reactive lymphadenopathy (on right side) 3 days following administration of FluMist.									U	11/24/2004	11/26/2004	2		PVT	UNK						1						2	Lymphadenopathy; Lymphadenopathy	FLUN3~MEDIMMUNE VACCINES, INC.~unknown~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0231328	12/21/2004	TX	38.0	38		F	12/07/2004	This is a non-serous case from a nurse reporting a patient experienced Lightheadedness:  after receiving FLUMIST. The reporter causality is not provided. This case is submitted according to the VAERS Safety Surveillance accelerated reporting agreement for FLUMIST. An adult patient experienced lightheadedness 20 minutes after receiving FLUMIST. The patient's clinical outcome is unknown.  Additional information has been requested.									Y	12/02/2004	12/02/2004	0		PVT	OTH	Concomitant drug(s) not reported.				MEDI0002527	1						1	Dizziness	FLUN3~MEDIMMUNE VACCINES, INC.~500355P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0231329	12/21/2004	TX	32.0	32		F	12/07/2004	This is a non-serious case from a nurse in the USA reporting a patient experienced Lightheadedness:  (Unlabelled, USA) after receiving FLUMIST.  The reporter causality is not provided.  This case is submitted according to the VAERS Safety Surveillance accelerated reporting agreement for FlLUMIST. An adult patient experienced lightheadedness 20 minutes after receiving FLUMIST. The patient's clinical outcome is unknown. The reporter causality was not provided. Additional information is being requested.									U	12/02/2004	12/02/2004	0		PVT	OTH	Concomitant drugs not reported.				MEDI0002529	1						1	Dizziness	FLUN3~MEDIMMUNE VACCINES, INC.~500355P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0231330	12/21/2004	AZ	58.0	58		F	12/16/2004	Client complaining of pain after injection, some mild redness immediately.  Ice pack applied.  Approximately 18 hours later - area with induration, red, warm to touch.  Ice applied, repeated.									Y	12/15/2004	12/16/2004	1		UNK	UNK	Medrol dose pack	NONE				1						1	Erythema; Feeling hot; Pain	FLU3~SANOFI PASTEUR~1558AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577P~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0231331	12/21/2004	CA	1.29	1	.3	F	12/16/2004	Febrile seizure at 02:00 following vaccines at 11:00AM.  No concurrent illness (ie. URI sx).  Was on bactrim for presumed MRSA but was at end of treatment. Medical Records received on 1/25/2005 states decreased mental status and eyes deviated right.				Y					Y	12/14/2004	12/15/2004	1		PVT	UNK		Resolving - 2 small skin abscesses	NKDA			1						1	Eye disorder; Febrile convulsion; Thinking abnormal	FLU3~SANOFI PASTEUR~1467AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0561N~UNK~IM~~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~67184C~UNK~IM~~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0231332	12/21/2004	NM	1.01	1	.0	M	12/15/2004	Pink, early vescicular lesions.									Y	11/22/2004	11/30/2004	8	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Skin ulcer	FLU3~SANOFI PASTEUR~1403AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1187N~UNK~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~74398A~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0116P~UNK~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0231333	12/21/2004	MA	62.0	61		F		48 hours post vaccine - patient developed hives on neck, arms, hands, trunk, legs, feet that were red, blistery, itchy.  Symptoms reoccurred for 8 days.  No symptoms on 9th day post vaccine.									Y	12/06/2004	12/08/2004	2		PVT	PVT	Xanax 1mg Atenolol 100mg Children's aspirin  K dur 20meg Lasix 20mg Coumadin 2.5mg Zoloft 25mg Lipitor 20mg vitamin C 500mg Folate 1mg Vitamin B12 500mg MCG Vitamin B6 Calcium Supplement 500mg Avandia 4mg Diovan 160mg Nitroglycerin 0.4mg P		Obesity, Elevated Serum, Cholesterol, Insomnia, Hypertension, Aortic Stenosis, Coronary Artery Disease, Depression, Back pain, Diabetes Mellitus, Menopausal Syndrome, Colonic Polyp, Grief reaction, Hernia, URI, Breast Disorder, Indigestion, Anxiety, Abdominal hernia, Epistaxis			1						1	Blister; Erythema; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~1504AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231334	12/21/2004	FL				F	12/01/2004	Temp. 100 degrees, nausea, body ache, dizziness, passed out.									Y	12/01/2004	12/02/2004	1		PUB	UNK	Zocor Synthroid Dioran Lantus, Novoloc	Diabetes				1						1	Dizziness; Loss of consciousness; Nausea; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0231335	12/21/2004	KS	66.0	65		M	12/14/2004	Chills, body aches, exhaustion on days 3-5 after the flu shot. Red rash with burning sensation on chest and back on days 6-7 after shot. Tired with rash gradually disappearing days 8-15.									Y	11/29/2004	12/01/2004	2	NONE	OTH	UNK	Lisinopril		Herniated disc operation last Feb. 04			1						1	Burning sensation; Chills; Fatigue; Pain; Rash	FLU3~SANOFI PASTEUR~U1451AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231336	12/21/2004	TX				U		Received vaccine about 2:00 p.m. on 12/10/2004. At approximately 5:30 p.m. noticed a knot about the size of a pea at injection site. It grew larger.									U	12/10/2004	12/10/2004	0		PVT	UNK		NONE	NKA			1						1	Injection site mass	FLU3~SANOFI PASTEUR~U1476AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231351	12/21/2004	CA	2.0	2	.0	F	12/20/2004	Patient had generalized tonic clonic seizure lasting approximately 3 hours: required not treatment.				Y					Y	12/16/2004	12/17/2004	1		PVT	PVT			Cleft lip			1						1	Convulsion	FLU3~SANOFI PASTEUR~U1U38AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~02423~1~~LL~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0231352	12/21/2004	ME	34.0	34		F	12/21/2004	24 hours after flumist was adminsitered patient complained of a severe migraine. The migraine has lasted for 7 days. She has been seen by her PCP and has been prescribed narcotic pain relievers which have no relived her symptoms.				Y					U	12/14/2004	12/15/2004	1		UNK	UNK		None	Possible rhinosinusitis			1						1	Migraine	FLUN3~MEDIMMUNE VACCINES, INC.~500356P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0231353	12/21/2004	WI	61.0	60		F	12/21/2004	Itchiness on day of administration, after 9 hours later.  Area size of quarter and warm where shot (flu) given is reddened and itchy.									U	12/17/2004	12/17/2004	0	N/A	UNK	UNK	Insulin, Clonidin, Prozac, Actose, Diuretic	None	Hypertension, Diabetes, Allergies to adhesive, penicillin and latex.			1						1	Injection site erythema; Injection site hypersensitivity; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~u1479AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231354	12/21/2004	NJ	12.0	12		M	12/21/2004	Petit mal seizure lasting 2 minutes, accompanied by vomiting.									Y	11/03/2004	11/04/2004	1	none	UNK	UNK	Trileptal, Risperdol, Allegra	no	Autism, epilepsy (last prior seizure 1 year ago).			1						1	Petit mal epilepsy; Vomiting	FLU3~SANOFI PASTEUR~U1489AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231356	12/21/2004	CA	1.6	1	.6	M	12/21/2004	Complex febrile seizure approximately 5-6 hours after flu vaccine. Medical Records received on 2/7/2005 states apnea and AE to Ativan.				Y	Y	1			Y	12/20/2004	12/20/2004	0	CSF and head CT NL	UNK	UNK		none	none.			1						1	Apnoea; Drug effect increased; Febrile convulsion	FLU3~SANOFI PASTEUR~U1470AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0231358	12/21/2004	OR	1.59	1	.6	M	12/21/2004	Patient had febrile seizure one day following vaccine administration.  Patient has had seizure in past following vaccinations (exact vaccines and time course unclear).  Patient's sister has had seizures the day following vaccinations in past times two.				Y					Y	12/14/2004	12/15/2004	1		UNK	UNK		no	Patient had previous seizure activity approximately 10 days after receiving DTaP, IPV, Prevnar, Influenza vaccines.			1						1	Condition aggravated; Febrile convulsion	DTAP~GLAXOSMITHKLINE BIOLOGICALS~6344a2~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~u1469aa~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1300n~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~a74398c~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0231360	12/21/2004	NC	15.0	14		M	11/08/2004	Received FluMist 10/27/2004. Developed fever 103F for two days and missed two days of school. No other signs or symptoms of respiratory infection. Medical Records received on 1/3/2005 states pt experienced headache, rhinitis, and viral syndrome. Headache, runny nose, chills. Dr states not disabled. Treated symptomaticly for viral illness.								Y	U	10/25/2004	10/25/2004	0	NONE	UNK	UNK	Minocycline for acne		NONE			1						1	Chills; Headache; Pyrexia; Rhinitis; Rhinorrhoea; Viral infection	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Disabling	Influenza
0231361	12/21/2004	MI		59		F	12/15/2004	Employee who received annual influenza vaccine, developed left facial paralysis. She reported to the ER for treatment. Cheif complaint quote: I felt clumsy when I was trying to eat my sandwich, then looked in the mirror and noticed my face is drooping. Diagnosis: Bells Palsy									U	11/30/2004	12/04/2004	4		UNK	UNK	Amlodipine PO, Aspirin PO, Zocor PO, Centrum PO, Tums PO, Proventil INH, Floven INH,		HTN, Asthma. Surgical history: ankle surgery, hysterectomy, tonsillectomy, adenoidectomy, mandible surgery. Pt does not use tobacco/alcohol. Health care worker, no significant family history.			1						1	Facial palsy	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231365	12/21/2004	NJ	52.0	51		F	10/28/2004	Patient received the flu shot on 10/20/04 in the left arm. Sore arm was noted upon administration on 10/21. Patient had a migraine headache: frontal/temporal: Nonchal rigidity: a pounding (force of contraction) But not racing heart (rate of contraction) HR80s. Symptoms gradually subsided. Symptoms totally dissipated by 10/23/04.									U	10/20/2004	10/20/2004	0		UNK	UNK						1						1	Migraine; Muscle rigidity; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0231366	12/21/2004	VA	10.0	10		F	11/22/2004	About 22 hours after Flumist was administered , patient began having symptoms including headache, myalgia (severe), extreme malaise, a low grade fever, chills and sweats; loss of appetite, slight nasal congestion. These symptoms were severe for the first 4 days and continue for 2 additional days with a decreased intensity. Patient missed 2 days of school.									U	11/13/2004	11/13/2004	0	?	UNK	UNK			History of seasonal allergies. Has been using Flonase since she was about 2.5 years old.			1						1	Anorexia; Chills; Headache; Hyperhidrosis; Malaise; Myalgia; Nasal congestion; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500333P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0231369	12/21/2004	OH	37.0	36		F	12/13/2004	Dizziness occurred 1-2 minutes following administration of FluMist. Lasted approximately 4 minutes.									Y	12/09/2004	12/09/2004	0		UNK	PUB						1						1	Dizziness	FLUN3~MEDIMMUNE VACCINES, INC.~500355P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0231378	12/22/2004	WI	60.0	60		F	12/22/2004	We both got flu shots at 10:15 am on 12/21/2004, and I took my wife to the clinic at 4:20 pm.  She had been having mild but increasing symptons for the previous one hour.  The nurse described the reaction as MODERATE.  They were hoarsness and wheezing; she was unable to take a deep breath through her mouth.  The treatment was nebulizer (?) breathing, with injections of a steriod and antihystamine.  We left the clinic at 6:30 pm with Methylpred 4MG PAK BARR and Diphenhydram 50MG perscriptions.									Y	12/21/2004	12/21/2004	0	Moderate Reaction to Flu shot.  The Doctor recommends to forego future flu shots	UNK	UNK		None	High Blood pressure and Glaucoma			1						1	Dysphonia; Dyspnoea; Wheezing	FLU3~PFIZER\WYETH~90658~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0231379	12/22/2004	CT	53.0	53		F	12/22/2004	I had the vaccine on 12/21/2004 at 9:00 a.m. and on my way home at 4:30 p.m.I experienced headache, dizziness, weakness and by the time I arrived home at 5:30 I was pale and had a fever of 102 degrees. I called my doctor and he told me to take tylenol.									Y	12/21/2004	12/21/2004	0		UNK	UNK		cough from post nasal drip	I had taken zithromax that was completed on 12/15/2004 for sinus infection and also have been taking previcid for silent reflux that was diagnosed by ear, nose & throat doctor			1						1	Asthenia; Dizziness; Headache; Pallor; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0231382	12/22/2004	CA	72.0	71		F	12/22/2004	6pm 12/16 non-pruritic red bumps on cheek and jaw; 12/16 confluent non-pruritic rash on chin, cheek, jaw, face ballooned, and skin hot with rash spreading to arms. Arthus type reaction rt arm. PMD 12/20 dx as reaction to PPV and tx with prednisone to which rash and edema is responding. No respiratory distress-able to run/walk 2+ miles per day. Just looks bad according to pt.				Y					Y	12/15/2004	12/16/2004	1	none	UNK	UNK						1						1	Arthralgia; Face oedema; Rash; Skin warm	FLU3~SANOFI PASTEUR~U1451AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0486P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0231386	12/22/2004	CA	0.56	0	.6	M	12/22/2004	Sterile abscess, left thigh at Pediarix injection site.  No history of fever or elevated temperature on date of vaccination or of today's visit for the nodule in the left thigh.  No redness, warmth, or tenderness at site of sterile abscess.  Parents noted the abscess incidentally yesterday.				Y					Y	12/15/2004	12/21/2004	6	None	UNK	UNK	None	Upper respiratory tract infection (rhinorrhea and cough only, no fever).	None			1						1	Abscess	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A003AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1528AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE436AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A57561F~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0231403	12/22/2004		48.0	47		F		A report was received from a 53 year old female consumer in the US on 5/10/04. No details were provided regarding the vaccinees medical history or concomitant medications. On 12/5/99, the vaccinee received an influenza vaccine IM. Three weeks after vaccination, the vaccinee developed neurological problems. She was eventually diagnosed as having GBS. She received treatment with IV immune Globulins, which was some benefit but she still experiences pain and disability to this day. The vaccinee describes herself as being 100% disabled as a result of developing GBS. Further information will be sought. Follow up received from the vaccinee on 11/1/04. On 12/5/99, the vaccinee received an influenza vaccine and a pneumonia vaccine. A few days later, the vaccinee developed laryngitis, which progressed into her chest and left her breathless. The vaccinee attended an emergency room and was treated with IV antibiotics for the breathlessness and coughing before being sent home with inhalers and antibiotics. The vaccinee then fell at home, hurt her knees and her fingers were purple from the fall. For two days the vaccinate experienced severe pain and sensations in her legs and the next day she began to drag her right leg and experienced numbness in her left leg. The vaccinee attended an emergency room where she underwent a brain scan which was normal. A diagnosis of foot drop was made and the vaccinee was fitted with braces up to her knees and prescribed physical therapy. The vaccinee attended her primary physician, who referred her to a neurologist and a diagnosis of Guillain Barre Syndrome was made. The vaccinee underwent 5 sessions of IV immunoglobulin therapy, which allowed her to raise her toes and feet, use her legs and lessened the heaviness in her arms. The vaccinee was also being treated at this time for depression and anxiety. The vaccinee then experienced muscle twitches, which caused her to sit-up in bed involuntarily. MRI scan, X-rays and CAT scan revealed that the pain in her back and legs was due to missing sheaths on the nerves in her back. The vaccinee has been treated with 5 epidurals, physical therapy and 36mg daily of Neurontin. The vaccinee is still experiencing pain in her legs, anxiety and depression and as a result is unable to work. Further information and medical validation will be sought. Follow up received from healthcare professional on 12/13/04. The vaccinees medical notes were provided by her primary physician. Administration of pneumococcal vaccine is not documented in notes. The vaccinee attended an emergency room on 12/23/99 with shortness of breath and coughing. COPD or Chronic bronchitis was suspected. The vaccinee was also noted to be tachycardic (in the region of 140 - 160). The vaccinee sustained a fall and hurt her right leg (date not specified). On 12/31/99 the vaccinee attended an emergency room, was diagnosed with right peroneal nerve palsy and referred for physical therapy. The vaccinee began to experience anxiety and depression on 4/7/00. CT scan of head and lungs (dates performed not provided) were negative. However EMA for right and left leg (date not provided) showed bilateral peroneal nerve palsy and the vaccinee was fitted with leg braces. Review of the vaccinees condition on 1/29/02 indicated that the vaccinee was feeling much better and her anxiety had improved. She was tolerating her medications well and was wearing braces on both legs. Her hypertension had also improved with the treatment for anxiety. The vaccinee was referred to a neurologist for treatment of her bilateral leg weakness, which is likely to be GBS. Laboratory tests on 10/16/02 showed that the vaccinees TSH and T4 levels were low. A copy of the neurologist's report will be requested.								Y	U	12/05/1999			T4 3.9; TSH 0	UNK	UNK	Concomitant drugs not reported.				CVOX200400320	1						1	Anxiety; Back pain; Contusion; Cough; Demyelination; Depression; Dyspnoea; Guillain-Barre syndrome; Hypoaesthesia; Injury; Laryngitis; Muscle twitching; Nervous system disorder; Pain; Paralysis; Peroneal nerve palsy; Sensation of heaviness; Tachycardia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Disabling	Influenza
0231409	12/22/2004	NY	77.0	76		M	12/20/2004	77 year old male was vaccinated with RSV vaccine or placebo and Influenza vaccine on 10/28/02 and 60 days later collapsed and died at home while showering. It was stated that the patient apparently died of cardiac arrhythmia. Relevant medical history includes a pacemaker in 1995, atrial fibrillation, angina, MI in 1991 and COPD. The subject was unblinded at the request of the investigator for documentation in view of organ donation. The participant received the RSV vaccine. The investigator assessed the event as unrelated to the study products. Additional information received on 12/17/04: The subject collapsed and died at home while showering. Apparently, the cause of death was cardiac arrhythmia. No death certificate is available. Additional information received on 12/20/04 from the investigator: The lot number for the study product was verified to be the same as the subject number and it was confirmed that this subject was unblinded.	Y	12/27/2002							N	10/28/2002	12/27/2002	60		UNK	UNK	Lanoxin; Prinovil; Atenolol; Lasix; Lopid; Coumadin; Aspirin; Flovent; Combivent; Axid; Dynbac		COPD, Pacemaker 1995, Atrial fibrillation, angina, MI in 1991, hypertension, edema, gastric reflux, bronchitis, elevated cholesterol.		F20030552	1						1	Arrhythmia; Shock	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0231414	12/22/2004	DE		1	.7	M	12/23/2004	Patient felt warm this AM and had a brief episode of stiffening then jerking then somnolence, seizure lasted 30 seconds.  Mom gave albuterol vin neb and ibuprofen prior to paramedics arriving.   1996 in EOC PM positive febute SZ, chest x-ray negative.				Y					Y	12/20/2004	12/23/2004	3	chest x-ray negative	PVT	UNK	Pulmacort, Albuterol Nebs, Singular, Zortec	Mild URI neg RSV	Asthma, Febrile seizures			1						1	Convulsion; Dyskinesia; Feeling hot; Somnolence	FLU3~SANOFI PASTEUR~1472AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~0554~UNK~SC~RL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~74405K~UNK~SC~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0231415	12/22/2004	NY	38.0	38		F	12/22/2004	Pain bilateral legs - started 2 days after flu vaccine.  Had MIR-EMG-CBC-S.5. Pt. was told all tests within normal limits. I suggested Neuro consult-scheduled for 01/14/2005. Medical Record received on 1/20/2005 states pt experienced paresthesia, weakness and sensory neuropathy.				Y					N	11/06/2004	11/08/2004	2	EMG done - MRI done- CBC- S-5 - Appointment with Neurologist 01/14/2005.	OTH	OTH	Bextra Flexiril	NONE	Muscle spasm back occasionally.			1						1	Myasthenic syndrome; Neuropathy; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~1523AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231416	12/22/2004	LA		5		F	12/23/2004	12/03/2004 at 1:35PM shots.  12/03/2004 evening felt dizzy - called Nurse on call told to go to ER. Pt then asleep and did not go.  12/04/2004 noticed bluish discoloration to lips and tongue that lasted a few minutes went to ER 2:12PM noted small welt on abdomen in waiting room and was itchy.  Discharged with no symptoms except small urticarial rash to arm.  Benadryl as needed and follow up with pediatrician.  Did not follow up.				Y					Y	12/03/2004	12/03/2004	0	NONE	PVT	PUB	Brorex Xopenex  Pulmocort Nasal	Otalgia - Reactive Airway Disease (breath cough clear)	Environmental allergies  Reactive Airway Disease			1						1	Dizziness; Pruritus; Rash; Skin discolouration; Tongue discolouration; Urticaria	FLU3~SANOFI PASTEUR~1516AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0649P~UNK~~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0231417	12/22/2004	CT		76		M	12/23/2004	Red, Swollen, warm to touch from right upper arm to elbow (not at injection site).  Lower arm from elbow to wrist became swollen the next day.  Seen at emergency walk-in clinic.  Treated with warm compresses, Benadryl and Augmentin.				Y					Y	12/17/2004	12/18/2004	1		PUB	PUB	Mobic Vicodin Vxton Mbropril Fosamax MVI Ecotrin	NONE	No known allergy			1						1	Erythema; Feeling hot; Swelling	FLU3~SANOFI PASTEUR~1518AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0945N~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0231418	12/22/2004	NC	20.0	20		F	11/22/2004	11/17/04 ER Physician told her to take OTC Benadryl for itching and urticaria. 11/18/04 Returned to the ER with increased swelling, redness hives or arms, chest, legs neck. Lips & eyelids began to swell. Denied any difficulty breathing or swallowing. IV Normal Saline, IV Benadryl 50 mg, Iv Pepcid 20 mg, IV Solumedrol 125 mg. Symptoms resolved over the course of an hour. Rx Prednisone 60 mg po daily x 4 days. Pepcid 20 mg  po daily x 14 days, Benadryl 50 mg q6hrs x2-3 days.				Y					Y	11/16/2004	11/17/2004	1	NONE	PUB	OTH	Foricet for migraines Vitamins	NONE	All cillins, Codeine, Pregnant		NC04127	1						1	Erythema; Pruritus; Swelling; Urticaria	FLU3~SANOFI PASTEUR~U1462AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231419	12/22/2004	CA	54.0	53		M	12/22/2004	Painful arm, headache, body ache: exhausted. Fever, weak- still sickish.									N	12/17/2004	12/17/2004	0		PUB	UNK						1						1	Asthenia; Fatigue; Headache; Malaise; Myalgia; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1556AA~6~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0605P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0231420	12/22/2004	CA	54.0	54		F	12/22/2004	Painful arm from collar bone to wrist, fever (101), aches, headache, weak unable to get out of bed for 2 nights and days. Still feeling ill 5 days later.									N	12/17/2004	12/17/2004	0		PUB	PVT		NONE				1						1	Headache; Myasthenic syndrome; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1556AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0605P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0231421	12/22/2004	CA	9.0	8		F	12/22/2004	Syncopal episode 5 minutes after administration of influenza vaccine. Child recovered fully within 5-10 minutes of observation.   Complete 12/24/05									Y	12/22/2004	12/22/2004	0		PUB	UNK		NONE	NONE			1						1	Syncope	FLU3~SANOFI PASTEUR~U1561AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231422	12/22/2004	SC	75.0	74		F	12/22/2004	Has red rash over body. Follow up 01/18/05: Lot number for vaccine not known.									N	12/21/2004	12/21/2004	0		PUB	UNK						1						1	Erythema; Rash	FLU3~PARKDALE PHARMACEUTICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0231423	12/22/2004	RI	1.31	1	.3	F	12/20/2004	Severe localized swelling and pruritus. Treated with Benadryl , Tylenol, Local cream. Both vax in same leg.				Y					U	12/18/2004	12/19/2004	1		PVT	PUB	Albuterol PRN		Bronchospasm			1						1	Pruritus; Swelling	DTAP~SANOFI PASTEUR~U1307AA~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1469AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231424	12/22/2004	GA				M	12/16/2004	Dec 1: developed upset stomach, by Dec 3: had chills and fever. By Dec 5, became disoriented while driving, had car wreck.				Y					Y	11/29/2004	12/01/2004	2		PUB	PUB						1						1	Chills; Disorientation; Injury; Pyrexia; Stomach discomfort	FLU3~SANOFI PASTEUR~U14555AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231425	12/22/2004	OK	56.0	56		F	12/13/2004	Red area on right arm, approximately 1.5-2 after receiving flu shot. Area warm to touch.									Y	12/10/2004	12/11/2004	1		PUB	UNK			Aortic and mitral valve leak.			1						1	Erythema; Feeling hot	FLU3~SANOFI PASTEUR~U1420AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231426	12/22/2004	MA	83.0			M	12/07/2004	5 days after getting flu shot at public clinic experienced painful and inflamed gums which required medical visit. Condition is improving.									Y	11/18/2004	11/23/2004	5		PUB	PUB					MA0404	1						1	Gingival pain; Gingivitis	FLU3~SANOFI PASTEUR~U1519AB~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231427	12/22/2004	VA	34.0	33		F		Around 20 min after receiving flu vaccine , patient complained of chest tightness. No SOB, hives, rash, wheezing. BP 120/80 HR 72 RR20. Undergoing chemotherapy. Oncologist notified, saw patient immediately at area hospital.				Y					U	11/22/2004	11/22/2004	0		UNK	PVT		Cancer : type unknown				1						1	Chest discomfort	FLU3~SANOFI PASTEUR~U1560AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231430	12/22/2004	AK	72.0	72		F	10/05/2004	30 minutes after vaccine administered, lump raised. 24 hours later: increased redness, swelling, tenderness around injection site. 48 hours later: swelling, redness from shoulder down to elbow. Painful and warm to touch.				Y					Y	10/02/2004	10/03/2004	1		PUB	UNK	Meds for hypertension		Hypertension			1						1	Erythema; Feeling hot; Injection site erythema; Injection site mass; Injection site swelling; Pain; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U1377AA~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0863N~2~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0231431	12/22/2004	OH	62.0	62		F	12/13/2004	Complaint of pain immediately with flu vaccine administration. Pain shot down arm to finger-tips. Eased some but the by the time patient got home, pain returned with nausea. Pain persisted x 4 days. Patient used Tylenol, Ultram, Heat cold massage. Had swelling in neck and arm on and off. Saw MD who advised to report. Pain eased on 5th day but still has not resolved. Also noted a pulling sensation in shoulder like muscle spasm.				Y					Y	12/07/2004	12/07/2004	0		PUB	PVT	Ultam, Tylenol, Diovan, Insulin Humulin 70/30 water pill.		Allergy: Aspirin, Sulfa, IDDM, HTN, Rheumatoid/Osteo Arthritis			1						1	Muscle spasms; Nausea; Pain; Swelling	FLU3~SANOFI PASTEUR~U1409BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231432	12/22/2004	TX	70.0	70		F	12/22/2004	Patient 12/21/04 reports bi-lateral inflammatory rash, swollen nodules on right arm, site of pneumococcal injection. Taking Benadryl. patient recovering at home.									U	12/16/2004	12/18/2004	2		UNK	PUB						1						1	Injection site nodule; Rash; Skin nodule; Swelling	FLU3~SANOFI PASTEUR~U1559BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0231433	12/22/2004	NY	16.0	15		M		This is a non-serious spontaneous case from a physician in the USA who reports a patient developed full body hives:  (Unlabelled, USA) after receiving FluMist.  The reporter did not provide causality between event and FluMist vaccination.  This case is submitted according to the VAERS Safety Surveillance accelerated reporting agreement for FluMist. At approximately 6pm on 12/14/2004, a 15 year old male received FluMist intranasally and developed full body hives approximately 7pm.  The patient received Benadryl (diphenhydramine) and responded well.  He was also given an oatmeal bath.  The patient recovered on 12/16/2004.									Y	12/14/2004	12/14/2004	0		PVT	OTH	Tetracycline		Not allergic to eggs.		MEDI0002586	1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0231434	12/22/2004	FL	46.0			M		This is a non-serious spontaneous case from a pharmacist in the USA who reports a patient experienced burning sensation:  (Unlabelled, USA)  after receiving FluMist.  The reporter causality is not provided.  This case is submitted according the VAERS Safety Surveillance accelerated reporting agreement for FluMist. On 11/23/2004, a 46 year old male received FluMist intranasally and experienced loss of smell and taste as well as burning sensation in back of throat on 11/25/2004.  He was given Septra (sulfamethoxazole), Medrol (methylprednisolone), Allegra D (fexofenadine/pseudoephedrine), and Rhinecort (budesonide).  He self medicated with saline nasal spray.  All events continued into 11/26/2004.  The reporter states the loss of smell and taste has not improved.  However, the patient thinks he might be able to sense the taste of sweetness to some degree.  The patient has not yet recovered from loss of smell and taste but the burning sensation in back of throat has subsided slightly.									N	11/23/2004	11/25/2004	2		PVT	OTH	Concomitant drugs not reported.				MEDI0002600	1						1	Ageusia; Anosmia; Skin burning sensation	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0231388	12/23/2004	TX	56.0	56		F	12/23/2004	Sudden profound hearing loss in left ear on November 6, 2004 after receiving flu vaccine on October 30, 2004.Tested twice by audiololgist, have seen speialist twice, MRI has ruled out acoustic neuroma.  Will see neurootologist on December 28, 2004.  Trying to get appointments with a neurologist and virologist.				Y					U	10/30/2004	11/06/2004	7	Tested twice by audiologist in the office.  MRI conducted to R/O acoustic neuroma.  Will see a neurootologist on December 28, 2004.  Further testing will be conduced through his office and currently trying to get appointments with neurologist and virologist.	UNK	UNK	None	None	None			1						1	Hearing impaired	FLU3~SANOFI PASTEUR~U1438AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231395	12/26/2004	NH	64.0	64		M	12/26/2004	Healthy, no symptoms prior to vaccination. Vaccinated at temporary clinic approx. 3PM.  Symptoms appeared within 24 hours.  Coughing, phlegm, headache, chills and fever.  Persist until this report (12-26-04).  Suspect that flu vaccine was rushed to meet emergency, and contained live virus.  Christmas ruined. Would like to know if others vaccinated in this mass operation were also affected.									N	12/20/2004	12/21/2004	1	none	UNK	UNK	none	none!	none			1						1	Chills; Cough; Headache; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0231396	12/26/2004	NH	64.0	63		F	12/26/2004	Healthy, no symptoms prior to vaccination. Vaccinated at mass temporary clinic approx. 3PM.  Symptoms appeared within 24 hours.  Coughing, phlegm, headache, chills and fever.  Persist until this report (12-26-04).  Suspect that flu vaccine was rushed to meet emergency, and contained live virus.  Christmas ruined. Would like to know if others vaccinated in this mass operation were also affected.  We will never get vaccinated again without determining the identity of the personnel, or the details of the vaccine (lot number, manufacturer, etc.) - an expensive lesson that free treatment can be costly.  My husband and I usually get our flu shots in a hospital at a small charge and have never experienced this.									N	12/20/2004	12/21/2004	1	none	UNK	UNK	none	none	none			1						1	Chills; Cough; Headache; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0231397	12/26/2004	TX	41.0	40		M	12/26/2004	Beginning 12-25-04, pt has reported muscle weakness to the point that he could not stand under his own power.  On 12-26-04 wife had to sit pt up in bed because he could not do so under his own power.  Recommended emergency attention.  Status/ treatment unknown. Discharge Summary received on 1/20/2005 states hypokalemic paralysis, tachycardia, and thyrotoxicosis. Medical Records received on 1/20/2005 states pt experienced anxiety, vomiting, nausea, and respiratory failure.									U	12/24/2004	12/25/2004	1	unknown. Discharge Summary received on 1/20/2005 states K low and CK elevated. Medical Records received on 1/20/2005 states thyroid labs elevated and cardiac lab elevated.	UNK	UNK	chlorpheniramine (otc)	Seasonal allergies	unknown. Discharge Summary received on 1/20/2005 states gout.			1						1	Anxiety; Hyperthyroidism; Hypokalaemia; Hypokinesia; Laboratory test abnormal; Muscular weakness; Nausea; Paralysis; Respiratory failure; Tachycardia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500335p~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0231458	12/27/2004	MD	77.0	76		M	12/27/2004	3 days after vaccination with inlfuenza vaccine, to right deltoid, noticed itching, then redness around vaccination site.  Upon examination today, redness about size of quarter, still complains of itching, small amount induration at injection site size of quarter.  Patient states redness is worsening over last few days.  Called primary physician, suggested cortisone cream over night.  Patient to call in morning if worse.									U	12/15/2004	12/18/2004	3		UNK	UNK	Casodex, Flomax, Provical, Fosomax	Treated for Prostate Cancer	NO			1						1	Injection site erythema; Injection site hypersensitivity; Injection site induration; Pruritus	FLU3~SANOFI PASTEUR~U1560AB~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231489	12/27/2004	MI	36.0	35		M	12/17/2004	Localized 8x9cm erythematous area at site of injection within 8 hours of administration.									U	12/16/2004	12/16/2004	0		PVT	UNK			DM2, HTN, Hyperlipidemia, Obesity			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U1409BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231490	12/27/2004	GA	29.0	28		M	12/10/2004	Redness and swelling around nose.									N	12/08/2004	12/09/2004	1		MIL	UNK	Percocet					1						1	Erythema; Rhinitis; Swelling	FLUN3~MEDIMMUNE VACCINES, INC.~500357~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0231491	12/27/2004	SC	38.0	37		F	12/16/2004	Metallic taste in mouth, burning/ tingling lips and tongue: intense itching.									Y	12/15/2004	12/15/2004	0		UNK	PVT	Atenolol 50 mg qd		Gastrografin, Macrolides, Tetracylines, Ceclor, Macrodane			1						1	Burning sensation mucosal; Dysgeusia; Paraesthesia oral; Pruritus; Tongue disorder	FLU3~SANOFI PASTEUR~U1521AB~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231492	12/27/2004	NY	65.0	65		F	12/16/2004	Hives started day after getting shot. Then got progressively worse. Went to ER given Benadryl. Went to doctor's office and given Prednisone dose pack. Symptoms resolved.				Y					Y	11/24/2004	11/25/2004	1		PUB	UNK	Synthroid, Norvase, HCTZ, Pravachel					1						1	Urticaria	FLU3~SANOFI PASTEUR~U1497AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231493	12/27/2004	OH	65.0	65		F		Severe arm pain, decreased mobility of arm.									U	12/07/2004	12/07/2004	0	MRI and referral to neurologist	PVT	UNK						1						1	Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~U1516AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0691P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0231494	12/27/2004	PA	72.0	72		F		Received Flu vaccine 12/2 at 1500: 12/2 developed chills, nausea at 20:00, 12/3 : chills, nausea, 12/4 chills, nausea, pain right hip to right knee. 12/5,12/6: vomiting/ diarrhea. 12/8: saw physician, Medrol dose pack: relief from pain. 12/9: pain right hip, right knee. Right knee replacement 2000 and right gamma rod rt femur 5/2003.				Y					Y	12/02/2004	12/02/2004	0	12/9 x ray , knee: no significant joint effusion	PUB	PVT	Prilosec, Elavil, Caltrate, Bextra, Darvocet, Flexeril		Codeine, Demerol, Morphine, Visteralm, Biaxin, bee stings.	chills, fever, nausea, vomiting, diarrhea~Influenza (Seasonal) (no brand name)~~57.00~Patient		1						1	Arthralgia; Chills; Diarrhoea; Nausea; Pain; Vaccine positive rechallenge; Vomiting	FLU3~SANOFI PASTEUR~U1443AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231495	12/27/2004	NY	64.0	63		F	12/17/2004	Patient noticed red, slightly raised area 2.5 diameter approximately 24 hours after the vaccine injection. It is less red, but slightly itchy and still 2.5 in diameter after six weeks.									U	11/03/2004	11/04/2004	1		PUB	PUB	Zocor, Imdur, Zestril, Aspirin		Coronary Artery Disease, Hypertension, Hypercholesterol			1						1	Erythema; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U1459~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231496	12/27/2004	TN	57.0	56		F	12/21/2004	Heart rate increased									Y	12/13/2004	12/14/2004	1		PUB	PVT	HCTZ, Atenolol, Zoloft, Xanax, Ambien	Fibromyalgia, Irregular heart rate, IBS	Fibromyalgia, Irregular heart rate, IBS			1						1	Heart rate increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0231497	12/27/2004	NH	1.04	1	.0	F	12/21/2004	Over 25 chicken pox									U	12/10/2004	12/18/2004	8		PVT	PUB		Exposed to chicken pox 11/16/2004				1						1	Dermatitis bullous	FLU3~SANOFI PASTEUR~U11469A~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0317P~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0654P~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0231498	12/27/2004	PA	61.0	60		F	12/09/2004	Numbness and tingling : tips of all fingers (index worst) and toes: began three days after flu vaccine. History stage 4 ovarian cancer. Treated June 02 to Nov 03 with Caneoplatinum and Taxotene (No pain history or ongoing symptoms)									N	10/21/2004	10/24/2004	3	HgA, C drawn due to hyperglycemia (160): Normal 515	PVT	PVT	Multivitamin					1						1	Hyperglycaemia; Hypoaesthesia; Laboratory test abnormal; Paraesthesia	FLU3~SANOFI PASTEUR~U1512AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231499	12/27/2004	MI	4.0	4		M	12/14/2004	Left arm. Thursday evening had temp of 102 x 2 inch red circle around site of injection. Fri AM more redness and by Friday afternoon around 3:30, arm was very swollen, red, hot, hard from shoulder to elbow. Treated in Emergency department with IM antibiotics. is on 10  day course of abx. On 12/14/04 mild swelling remains, but symptoms much improved.				Y					Y	12/08/2004	12/09/2004	1		PUB	PUB	Zyrtec		Allergies: unsure	death~DT Adsorbed (no brand name)~4~1.08~In Sibling		1						1	Erythema; Feeling hot; Injection site erythema; Injection site induration; Pyrexia; Swelling	DTAP~SANOFI PASTEUR~C1698AA~5~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1521AB~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1191~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0041P~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0231500	12/27/2004	CO	7.0	7		F	12/17/2004	Swelling right thigh 10x9.5 cm with erythema and warm to touch at sit of Td left thigh, Hep A right thigh, Flu vaccine right thigh given 12/15/04. Reported by parent on 12/17/04. Given Keflex and Benadryl.									Y	12/15/2004	12/16/2004	1	NONE	PVT	PUB	NONE	NONE	Asthma			1						1	Erythema; Feeling hot; Swelling	FLU3~SANOFI PASTEUR~U1476AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~073AP~2~IM~RL~HEP A (HAVRIX)~1|TD~AVENTIS PASTEUR~U1280AA~5~IM~LL~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0231501	12/27/2004	MI	37.0	37		F	12/15/2004	Left arm at injection site became red and rash started 12/6 pm. Progressed to hives over body during night and through 12/7. Saw own primary care physician and obstetrician. Hives improving with Benadryl and Zantac.									Y	12/06/2004	12/06/2004	0		PUB	UNK	Prenatal Vitamins		Pregnant: Gestation 11 weeks			1						1	Injection site erythema; Rash; Urticaria	FLU3~SANOFI PASTEUR~U1521AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231502	12/27/2004	MI	45.0	44		F	12/10/2004	Right arm started itching later in day, no redness noted at site. 12/9/2004 increased itching with nickel size red area at injection site. Started nausea evening 12/9. 12/10 am injection site reddened, raised around 2.5-3cm, nausea persisted 12/10/04 3 pm denies, nausea.									Y	12/08/2004	12/08/2004	0		PUB	UNK						1						1	Injection site erythema; Injection site swelling; Nausea; Pruritus	FLU3~SANOFI PASTEUR~U1521AB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231504	12/27/2004	PA	83.0	83		F	12/27/2004	Has taken flu vaccine for 5-6 years with no problem. On 12/20 at 7:00pm noticed red hives around mouth area but notes that she usually gets those when weather changes. On 12/21 woke up with headache, took two Tylenol, felt more tired than normal. Fell asleep at 8:00pm for 3.5 hours which is very unusual. According to mom was coughing while sleeping. On 12/22 took two Tylenol again, felt okay during day but at night started losing voice. On 12/23 felt dizzy, weak, coughing, lost voice , started to use inhaler every four hours. Had muscle cramps (even on feet) and chills. On 12/24: coughing spasms started, muscle aches continued, sore throat, headaches coming and going, coughing phlegm. Vomiting and diarrhea started. On 12/25 : continued to throw up until it subsided on Sunday. Today 12/27 feels much better.									Y	12/20/2004	12/20/2004	0		PVT	PVT	Advair, Singulair, Clarinex, Ibuterol and HCTZ (BP medicine)	headache, asthma, scratchy throat	asthma, allergic to mercury			1						1	Asthenia; Condition aggravated; Cough; Diarrhoea; Dizziness; Dysphonia; Fatigue; Headache; Muscle spasms; Myalgia; Urticaria; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0210878	12/28/2004	ME	54.0	54		M	11/11/2003	From initial information received on 24OCT2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 54 year old male patient received a dose of FLUZONE , administered IM in the left deltoid on 21OCT2003 at 9:45AM. 75 minutes later, at 11:00AM, the patient states that he was not feeling well and was feeling faint. He was diaphoretic and complained of dyspnea and numbness in this right arm. His vital signs were taken and his blood pressure was 80/60 , pulse 60 and respiration 24. The patient was taken to the ER via ambulance and his treatment included Benadryl , given IV over one minute. He stayed for observation and was later discharged. On 22OCT2003, the pt had returned to work, but stated that he did not feel that good yet. He reported that he had Benadryl to take if needed. It was reported that the patient had recovered form these events.				Y					Y	10/21/2003	10/21/2003	0	Vitas signs: BP 80/60, pulse 60, respiration 24	PUB	UNK	Depakote, Dilantin, Tegretol		Allergy to penicillin and a seizure disorder to to GSW.		200302720	1						2	Dyspnoea; Hyperhidrosis; Hypoaesthesia; Malaise; Syncope	FLU3~SANOFI PASTEUR~U1269AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0210948	12/28/2004	FL	53.0	53		F	11/04/2003	From initial information received on October 20,2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that two patients received a dose of Fluzone SV '2003-'2004 USP, lot number U1076AA, (route and site of administration not reported) on an unspecified date.  An unspecified time after administration of the vaccine, the patients developed swollen tongues and throats.  The recovery status was not reported. From additional information received on October 23,2003 from a healthcare professional, it was reported that a 53 year old female patient received Fluzone SV '2003-'2004 USP, lot number U1270AA, administered intra-muscularly in the left arm on October 07,2003 at 1:00PM.  Five hours later, the patient developed a sore arm with erythema at site of injection.  Over the next several hours, it progressed to cover the upper front half of the arm and the patient also experienced swelling to the elbow.  She also developed tongue swelling and developed small tongue blisters and upper respiratory congestion.  The patient required an emergency room/doctor visit and she was treated with Benadryl over the first 24 hours and Keflex for mild cellulitis of the upper arm.  The mouth swelling resolved within 12 hours and the respiratory congestion lasted 24 hours.				Y					Y	10/07/2003	10/07/2003	0	NONE	OTH	PVT	Ziac	NONE	The patient has a history of hypertension, for which she take Ziac.		200302661	1						2	Blister; Cellulitis; Injection site erythema; Joint swelling; Pharyngeal oedema; Tongue oedema; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~U1270AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0210949	12/28/2004	FL	32.0	32		F	11/05/2003	From  initial information received on 20OCT2003, which did not contain any identifiable patient information, and additional information received on 23OCT2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 32 year old female patient received Fluzone 2004USP, administered IM in the left a4rm on 16OCT2003 at 12:00PM. The patient had received two previous influenza immunizations in the pat. Four hours later, the patient developed a local reaction of erythema and swelling at the site, which progressed to cover the upper third of the arm. The patient also developed selling at the back of her throat with upper respiratory congestion, which lasted approximately two days. The patient was given Benadryl for her symptoms. Her pre-existing medical conditions include asthma and hypertension. Reportedly, the patient recovered form this event. The reporter of this case is the same reporter of case 200302661				Y					Y	10/16/2003	10/16/2003	0		UNK	PVT	ANSYN: BP Medication		Asthma and hypertension, for which she had ANSYN..		200302688	1						2	Condition aggravated; Injection site erythema; Injection site swelling; Pharyngeal oedema; Pulmonary congestion	FLU3~SANOFI PASTEUR~U1270AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0211067	12/28/2004	CT	36.0	35		F	02/02/2004	Injection site cellulitis - Injection site erythema Injection site warmth Injection site mass Headache From initial information received on 10/27/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 35 year old female patient received a dose of Fluzone SV 2003-2004 USP, lot number U1270AA, administered in the left triceps on 10/22/2003 ay 11:00 AM. The following day, the patient developed a headache. She also had erythema and a wheal measuring 6cm x 4.5cm at the injection site, which was also warm to the touch. The patient applied heat to the region. She went to the emergency room where she was given antibiotics for cellulitis of the left triceps. The patient had previously received the influenza vaccine approximately five to eight times in past years. Reportedly, the patient recovered from these events.				Y					Y	10/22/2003	10/23/2003	1		PVT	PVT			Cervical and lumbar sprain, otherwise good health. The patient has received approximately five to eight influenza vaccines in previous years.		200302791	1						2	Cellulitis; Feeling hot; Headache; Injection site erythema; Injection site mass; Urticaria	FLU3~SANOFI PASTEUR~U1270AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0211753	12/28/2004	WI	61.0	60		M	12/16/2003	From initial information received on 10/11/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 60 year old male patient received FLUZONE SV '2003-'2004 USP, lot number U1148CA, administered intramuscularly in left deltoid, and a first dose of PNEUMOVAX 23, lot number 0988N, administered in the right deltoid on 10/29/2003 at 10:00 AM, 14 hours later, at midnight on 10/30/2003, the patient developed a very large area of erythema (redness) measuring approximately 14 inches to 16 inches long and approximately four to five inches wide. The area extended from in front of the armpit tp below the elbow on the inner aspect of the arm. There was no itching, but the arm was a little sore. The patient was seen by a physician on 10/31/2003 and was treated with Allegra, Tylenol and ice to the area. The patient recovered from this event as of 10/31/2003. No other information was reported.				Y					Y	10/29/2003	10/30/2003	1		PVT	OTH			Allergy to bees. The patient had received an influenza vaccine the previous year.	Injection site redness~Vaccine not specified (no brand name)~1~0.00~In Patient	200302852	1						2	Erythema; Pain	FLU3~SANOFI PASTEUR~U1148CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0988N~1~~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0212192	12/28/2004	NM	29.0	28		F	04/29/2004	From initial information received on 11/13/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 28 year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1097AA, administered intra-muscularly in the right deltoid on 10/16/2003 at 10:00AM.  10 days later, on 10/26/2003 at 7:00AM, the patient awok with pain in her foot.  She did not have any known injuries.  Three days later, on 10/29/2003, the pain had moved from her foot into her ankle.  A neuroma vs cellulitis/phlebitis was suspected.  She was prescribed unspecified antibiotics.  On 11/03/2003, the fourth day of being on the antibiotics, she had a positive tendon range of motion and her legs were stable.  She did have pain in the anterior tibial tendon (described as a third of the way up), as well as pain upon palpation of the arch of her foot (plantar and dorsal).  The patient was referred to another physician, where her symptoms were diagnosed as viral synovitis.  The patient's recovery status is currently unknown at the time of the report.				Y					U	10/16/2003	10/26/2003	10	The patient had x-rays of the foot and ankle, as well as an arthritis and gout panel.  No results were provided.  Further labs are needed as per the reporter.	PVT	MIL		NONE	Allergy to penicillin.		200302986	1						2	Arthralgia; Cellulitis; Neuroma; Pain in extremity; Phlebitis; Synovitis	FLU3~SANOFI PASTEUR~U1097AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0212267	12/28/2004	TN	71.0	71		F	01/06/2004	From initial information received on 11/13/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 71 year old female patient received Fluzone SV'2003-'2004 USP, lot number U1095AA, administered intra-muscularly in the left deltoid on 10/20/2003 at 1:20PM.  Five minutes later, the patient told her husband the she was 'going to pass out'.  At 1:30PM, the patient was not responsive to sternal rub.  She was put on the floor with her legs in the air.  She became responsive and was alert and oriented to person, place and time.  The patient was flushed.  At 1:35PM, she was sitting up and nausea was noted.  She was transferred to a stretcher at 1:37PM.  Her blood pressure was 156/90 at that time.  At 2:04PM the patient was ambulatory and refused to use a wheelchair.  She was instructed to call her primary care physician.  The patient recovered from these events. The reporter of this case is the same reporter of case 2003-02988.									Y	10/20/2003	10/20/2003	0		PUB	UNK			Allergic to latex.		200302987	1						2	Nausea; Syncope	FLU3~SANOFI PASTEUR~U1095AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0212318	12/28/2004	MI	25.0	24		M	12/29/2003	From initial information received on 11/14/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 24 year old male patient received his second dose of Fluzone SV '2003-'2004 USP, lot number U1255AA, administered intra-muscularly in the right deltoid, and a second dose of Hepatitis A vaccine, lot number 0981M, administered intra-muscularly in the left deltoid on 11/10/2003 at 6:00PM.  Approximately one to one and a half hours later, the patient developed a raised rash on his neck, back, flank, and thighs.  Nothing was noted at the immunization sites.  The patient's mother gave him Benadryl and the rash vanished later that evening with no recurrence.  Reportedly, the patient recovered from these events.									Y	11/10/2003	11/10/2003	0		PVT	UNK	Fiber Pill				200303018	1						2	Rash	FLU3~SANOFI PASTEUR~U1255AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~MERCK & CO. INC.~0981M~2~IM~LA~HEP A (VAQTA)~2	USA		Influenza
0212699	12/28/2004	MI	50.0	49		F	04/30/2004	Injection site reaction - injection site discoloration - injection site edema - injection site pain From initial information received on 11/25/2003 from a registered nurse regarding an adverse event occurring in the U.S.A., it was reported that a 49 year old female patient received a dose of FLUZONE SV '2003-'2004 USP, lot number U1081AA, administered intra-muscularly in the left deltoid on 10/21/2003 at 3:00 PM. 16.5 hours later, on 10/22/2003 at 7:30 AM, the patient developed an injection site reaction consisting of discoloration, edema and soreness. The soreness extended under her arm. Treatment included ice packs and Benadryl 50 mg every four to six hours as necessary. Reportedly, the patient recovered from these events. The reporter of this case is the same as for case U2002-01131.				Y					Y	10/21/2003	10/22/2003	1		OTH	OTH					200303259	1						2	Injection site oedema; Injection site pain; Pain; Skin discolouration	FLU3~SANOFI PASTEUR~U1081AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0212757	12/28/2004	NJ	73.0	73		M	09/24/2004	From initial information received on 13Nov03 from a health care professional regarding an adverse event occurring, it was reported that a 73 year old male pt received a dose of Fluzone SV 2003-2004 USP, lot number U1076AA, administered IM in the left arm on 21Oct03. Four days later, the pt developed a fever (no temp provided) and general malaise. The pt was hospitalized with a diagnosis of fever, etiology to be determined. The pt was hospitalized for eight days and was discharged on 02Nov03. The pt's recovery status is currently unk. 22Sep04: Despite continued attempts to obtain follow up, no further information was provided. No further information is anticipated, this case is considered closed.				Y	Y	8			U	10/21/2003	10/25/2003	4		PUB	UNK		NONE	UNK		200302989	1						2	Malaise; Pyrexia	FLU3~SANOFI PASTEUR~U1076AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0214013	12/28/2004	MI	60.0	60		M	04/28/2004	From initial information received on 15Dec03 from a physician regarding an adverse event occurring, it was reported that a 60 year old male pt received a dose of Influenza vaccine, lot number 765666, administered IM in the left arm. Reportedly, the lot number does not match that of the manufacturer's Influenza vaccine. Immediately after immunization, the pt developed a red rash on the left side from elbow to shoulder, which lasted one week and arthralgias, which started eight hours after vaccination and have persisted since. Reportedly, the pt is improving. No other information was provided at this time.									U	11/20/2003	11/20/2003	0		PVT	OTH					200303397	1						2	Arthralgia; Injection site erythema; Injection site rash	FLU3~SANOFI PASTEUR~765666~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0214089	12/28/2004	OH	4.0	3		M	04/28/2004	From initial information received on 12/12/03, from a health care professional regarding an adverse event occurring in the USA, it was reported a 3 year old male patient received his first dose of Fluzone SV '2003-'2004 USP, lot number U1260AA, administered in the right leg (route of administration not reported), on 12/03/03 after 1-3 PM. Three days later at 8:00 AM of 12/06/03, the patient developed clear liquid vomiting. There was no fever, chills or diarrhea. The patient was in the emergency room twice and then was seen in another room. Reportedly, the patient recovered from this event.				Y					Y	12/03/2003	12/06/2003	3	Unknown	PUB	OTH		NONE	No known allergies. No birth defects or medical conditions.			1						2	Vomiting	FLU3~SANOFI PASTEUR~U1260AA~UNK~~RL~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0214203	12/28/2004	KS	6.0	6		M	04/29/2004	From initial information received on 11/24/03 from the patient's parents regarding an adverse event occurring in the USA, it was reported that a 6 year old male patient received a dose of Fluzone SV '2003-'2004 USP, lot number, route and site of administration not reported, on 11/13/03. Two days later, on 11/15/03, the patient developed a rash over his body. He was treated with Benadryl orally every 6 hours and steroids. The patient's recovery status is currently unknown. His past medical history is significant for allergies to penicillin, sulfa and cephalosporins, for which he develops a rash.									U	11/13/2003	11/15/2003	2		UNK	UNK	Nexium	NONE	The patient has a history of allergies to penicillin, sulfa and cephalosporins. His reaction is reported as a rash.		200303232	1						2	Rash	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0216759	12/28/2004	CA	71.0	70		F	07/16/2004	From initial information received on 11/12/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 70 year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1260AA, on 09/30/2003.  The route and site of administration were not reported.  Seven days after receiving the vaccine, the patient developed muscle weakness.  The patient's recovery status is currently unknown. From additional information received on 02/23/2004 from a physician, the patient's full name and address as well as her date of birth were provided.  The reporter's fax number was also provided.  The patient received the vaccine in Los Angeles county on 09/30/2003 at 11:00AM, administered intra-muscularly in her right deltoid.  The following day, the patient developed muscle aches, flu-like symptoms, fever and weakness in her arms and legs.  She was treated with Neurontin, Vicodin and vitamin B6 therapy.  At the time of vaccination, the patient also took Cozaar 50mg twice daily, Mevacor 20mg once a day, Prilosec 20mg once a day, Amitriptyline daily, Catapres, Neurontin and Cipro 50mg twice daily for 10 days for urinary tract infection.  Reportedly the patient received two previous doses of the Fluzone vaccine, one in 2001 and one in 2002.  The patient's past medical history includes allergic rhinitis and she has allergies to penicillin, all sulfa drugs, Valium, iodine, Propulsid, aspirin, theophylline, estrogen, zaroxolyn, procardia and prednisone.  Reportedly, the patient did not recover from these events. From additional information received on 07/07/2004 from the reporting facility, it was reported that the information has been reviewed on 06/28/2004 and no additional information is available at this time. Further information is not anticipated.  This cases is considered closed.				Y					Y	09/30/2003	10/01/2003	1		PVT	PUB	Amitriptyline, Atrovent, Catapres, Cipro, Cozaar, Mevacor, Miacalcin, Neurontin, Pepcid, Prilosec, Vanceril	NONE	Allergic rhinitis, allergies to penicillin, all sulfa drugs, valium, iodine, propulsid, aspirin, theophylline, estrogen, zaroxolyn, procardia and prednisone.		200302983	1						2	Asthenia; Influenza like illness; Pain; Pyrexia; Influenza like illness; Muscular weakness; Myalgia; Pyrexia; Urinary tract infection	FLU3~SANOFI PASTEUR~U1260AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1260AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0216764	12/28/2004	CA	66.0	65		F	07/02/2004	From initial information received on 2/18/04 from the patient, regarding an adverse event occurring in the USA, it was reported that the 65 year old female received a dose of Fluzone, lot number U1256AA, administered in the right deltoid on 11/5/03. Two days later, the patient developed severe pain in the upper right quadrant, which extended to the spine upon going in to a sitting position or turning. She also described a feeling of fullness like a balloon inside. She stated that the pain was less severe when walking. Reportedly, the patient also developed shingles on an unspecified date. She was seen by a physician and treated with unspecified medication for shingles, as well as pain medication. Reportedly, the patient did not recover from these events and was still experiencing the feeling fullness at the time of this report. From additional information received on 6/28/04 from the patient, it was reported that the patient started to experience symptoms two days after immunization. Symptoms were treated with a total of five shots of Toradol administered IM. Reportedly, the patient continues to occasionally experience a feeling of fullness in the lower and upper abdomen, but it is less frequent and no longer feels like a balloon. At the time of vaccination, the patient was taking Fosamax for osteoporosis, Lotensin for high blood pressure and Lipitor for high cholesterol. She was still experiencing a pain in her left leg from a fracture. Pre-existing medical conditions include osteoporosis, elevated blood pressure, and elevated cholesterol. In addition, the patient provided the name and address of the physician who treated the symptoms.				Y					U	11/05/2003	11/07/2003	2	CT scan of pelvis and abdominal area (no results provided). Ultrasound performed (no results provided).	OTH	PVT	Fosamax; Lotensin; Lipitor	NONE	Coming off crutches after broken leg. Taking Fosamax for osteoporosis, Lotensin for high blood pressure and Lipitor for elevated cholesterol.		200400544	1						2	Abdominal distension; Herpes zoster; Pain; Rash; Abdominal distension; Abdominal pain upper; Herpes zoster	FLU3~SANOFI PASTEUR~U1256AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1256AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0217076	12/28/2004	MN	50.0	49		F	09/17/2004	From initial information received on 02/25/04 from a county health service regarding an adverse event occurring in the USA, it was reported that a 49 year old female patient received a Fluzone SV '2003-'2004 USP vaccination, lot number U194AA, administered intramuscularly in the left deltoid, and a Pneumovax 23 vaccination, lot number 0029N, administered intramuscularly in the right deltoid on 11/10/03 at 5:00 PM. Thirty minutes later the patient noted dizziness at home. At 8:00 PM, the patient went to bed with soreness of both arms with the left on being worse that the right. She experienced absolute fatigue, headache and sinus feeling pressure. She took Tylenol, Ibuprofen and another medication for relief. The patient  had a rough night up six times to get relief of pain, aches in knees in the night. On 11/12/03, the symptoms kind of lifted. Her left arm was still sore, shoulder joint to knuckles stiff and could not be used, muscles felt sore and injection site was hot. Her right arm had minimal soreness. She felt miserable and had no appetite. Her sinus headache went to a migraine in the afternoon. She took a long nap, couldn't quite put her knees together and she ached. In the afternoon, she felt chilled. At 6:00 Pm she began shivering under three quilts, vomited and diarrhea started. She was taking a lot of Ibuprofen. On 11/13/03, the headache resolved, but she couldn't bend her elbow. She slept in the afternoon and felt better so she went to work. As she was driving she became hot and could no longer drive. She felt like  I had run a marathon. She went to the doctor for another reason and the doctor noted a fast heart rate. On 11/14/03, her arm began to bend. Her stomach was upset and she didn't want to eat. She began to have a sinus headache, more diarrhea and noted dark stools. She experienced a nosebleed and dizziness at intervals. It was at this time the patient called the county health service and was encouraged to seek medical attention and to report the above events at which time she refused. On 11/15/03, the patient did not eat breakfast, did not have an appetite and had a nervous stomach. She denied any headache and migraine and can now move her fingers. Her knee aches and elbow aches have subsided. On 11/20/03, her shoulder to elbow was stiff. On 11/30/03, she experienced stiffness and aches. The patient has stated I have had 4 bouts of flu like symptoms about every 10 days following my shot. The patient did not seek medical evaluation from her medical provider because she has had reactions in the past and reportedly physician thinks she is somewhat of a hypochondriac. The patient has completely recovered from these events. From additional information received on 09/13/04 from the initial reporter, the patient was not on any other medications at the time of vaccination. The patient refused to go to a medical provider. The reporter stated that the case was reviewed and that there is no additional information at this time. No further information is anticipated, this cause is considered closed.									Y	11/10/2003	11/10/2003	0	NONE	PUB	PUB	Tylenol and Ibuprofen	NONE	Sensitive to yeast.		200400735	1						2	Anorexia; Arthralgia; Chills; Diarrhoea; Dizziness; Epistaxis; Fatigue; Headache; Heart rate increased; Joint stiffness; Migraine; Pain; Sensation of pressure; Sinus headache; Sleep disorder; Vomiting; Abdominal discomfort; Anorexia; Arthralgia; Chills; Diarrhoea; Dizziness; Epistaxis; Faeces discoloured; Fatigue; Feeling hot; Heart rate increased; Hypokinesia; Influenza like illness; Injection site warmth; Joint stiffness; Migraine; Myalgia; Pain; Sinus headache; Vomiting	FLU3~SANOFI PASTEUR~U1094AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0029N~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U1094AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0029N~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0225660	12/28/2004	KY	1.75	1	.7	F	09/13/2004	From initial information received on 08/19/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 21 month old female patient received a 0.25 cc dose of Fluzone SV '2003-'2004 USP, lot number U1128AA, administered intramuscularly in the left deltoid on 11/07/03. Two weeks later, on 11/21/03, the mother stated that the child's hair started falling out. No lab work was done. Reportedly, the patient recovered from this event. From additional information received on 08/31/04 from a registered nurse, it was reported that the patient's mother stated within tow weeks after receiving Fluzone on 11/03, the patient's hair started falling out. the patient also developed trouble with her language use. One to two weeks post vaccination, the patient could only speak the beginning syllable of a word and not finish it.  All MRI test were normal. Reportedly, the patient's hair has grown back, but her language use has not returned. A follow up telephone call was placed on 09/07/04 to the reporting nurse. She stated that the patient has not been tested fro autism. She was last seen at the office for her two year physical, , at which time physical therapy had been discussed. At the time of the visit, the patient had recovered from the hair loss, but was still having issues with her speech. The reporter stated that the patient had documented sensory integration issues and that there were multiple concerns about her speech and hearing prior to receiving the vaccine on 11/07/03. The reporter was unable to provide any additional information at this time and stated tat the physician who last saw the patient in their office is currently out on long term medical leave.									N	11/07/2003	11/21/2003	14	MRI normal	PVT	PVT	Flovent, Zyrtec and Nasonex		The patient has a history of sensory integration issues. She had no illness at the time of vaccination. The patient did not have any adverse reactions following prior vaccination.		200402855	1						2	Alopecia; Speech disorder; Alopecia; Speech disorder	FLU3~SANOFI PASTEUR~U1128AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~u1128AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0231462	12/28/2004	FL	24.0	24		M	12/28/2004	Erythematous ring around injection site approx 7/5 cm by 10 cm in diameter.  No signs of infection (blood or exudates) from injection site.  Erythematous ring warm to touch and elicited some minor pain.  Left arm.									Y	11/23/2004	11/25/2004	2	Cellulitis	MIL	MIL		none	none			1						1	Cellulitis; Erythema; Feeling hot; Pain	FLU3~SANOFI PASTEUR~U1515AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4030013~1~ID~RA~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~X0850~1~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0231463	12/28/2004		22.0			M	12/28/2004	Patient is 22-year-old male who received the smallpox vaccine on 17 Dec 2004 who presents with complaints of distal lesions from the vaccination site.  Patient reports having an itchy area on his elbow and when he looked at his elbow he saw that he had a rash.  He reports two or three new little papules at the site.  He reports feeling lightheaded yesterday.  He was reportedly pale.  No fevers but he did complain of being chilled.  No nausea or vomiting.  He does say that his stomach felt weird.  He reports it was a sharp pain but it went away on its own.  No headaches.  No chest pain.  Due to deploy on the 12th of this next month.   No history of skin problems or history of psoriasis.   MEDICATIONS: 1. None  PMH: 1. None  MED ALLERGIES: 1. NKDA  Family History: No allergies or problems with medications  Social History: Non-smoker  Infectious History:  no history of recurrent infections or bad infections a/ generalized vaccinia				Y					Y	12/17/2004	12/27/2004	10	None	MIL	MIL	None	None	None			1						1	Abdominal pain upper; Dizziness; Feeling cold; Injection site reaction; Pruritus; Rash; Vaccination complication	FLU3~SANOFI PASTEUR~U1131AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4030013~1~~LA~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~X0862~1~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0231530	12/28/2004	MI	86.0	85		M	06/07/2004	From initial information received on 16Mar04 from a physician's office, regarding an adverse event occurring, it was reported that an 85 year old male pt received Fluzone SV 2003-2/4 USP, lot number U1131AA, administered IM in the left deltoid on 10Nov03.The pt had no reaction at the time of vaccination. He visited his physician for a regular office visit on 31Dec03 and had no complaints. On 02Jan04, he was seen in the ER for bilateral leg and arm weakness. This was his second visit to the ER, but no details were provided regarding his first visit. He was admitted to the hospital on 02Jan04 and was diagnosed with Guillain Barre Syndrome. The pt's recovery status is unk. From additional information received on 28May04 from a physician, the pt's hospital records were provided. The pt was admitted to the hospital on 02Jan04 with a three to four day history of progressive arm and leg weakness to the point where he had to walk with a cane and felt like he could fall when he was ambulating. Vital signs were stable on admission. Upon initial exam, the pt appeared weak and had difficulty getting out of bed. He was unable to push himself into a sitting position using his arms. His lower extremities appeared to be areflexic. He had a slightly positive Babinski. Romberg testing was negative. Pronator drift testing was also negative. His gait was watched without ataxia. Cerebellar testing of the lower extremities was normal. The pt denied concurrent fever, shortness of breath, coughing, muscle fasciculations or numbness or tingling of the hands or feet. He also denied exposure to botulism. Reportedly, the pt had not had any tick bites or traveled recently. A CAT scan of the brain on 02Jan04 revealed chronic findings with no acute anomaly identified. The pt's recovery status was not reported.				Y	Y				U	11/10/2003	01/02/2004	53	Urinology, EKG, CBC, SMA-12, CDC, CK, troponin, CT of brain, and neurological examinations were performed, however, no results were provided at the time of this report. His pulse oximetry was 94, blood pressure 130/75, pulse 90 and respirations 18. CT of the brain completed on 02Jan04 revealed chronic findings with no acute anomaly identified. Chest PA and lateral also completed on 02Jan04 revealed an apparently new right lobe nodule with stable left mid lung nodule. Atherosclerosis and chronic basilar atelectasis were noted with no other acute findings. Laboratory testing completed on 02Jan04 included the following: Urinalysis: urine spec gravity elevated at 1.025 (normal range 1.016-1.022), urine ketones-trace (normal: negative). CBC: RBC low at 4.20x10^6/uL (normal range 4.70-6.00) Hemoglobin low at 13.0g/dl (normal range: 13.5-18.0), Hematocrit low at 37.6% (normal: 43.0-65.0), Lymphocytes low at 1.4X10^3/uL (normal: 1.5-3.5), Metabolic panel: albumin low at 3.5G/dL (normal: 3.9-5.0), A/G ratio low at 1.1 (normal: 1.2-2.2), SCPT/ALT low at 16u/L (normal: 21-72), CPK Serum was low at 42u/L (normal range: 55-170), Influenza A/B antigen was neg. RA Latex completed on 03Jan04 was negative, HIV antibody screen completed on 04Jan04 was neg. Mono screen, Hep C antibody CR and ANA ANF completed on 05Jan04 were neg. EB virus CVA-IGM, Hep B antibody and Hep B antigen completed on 06Jan04 were neg. EB virus VGA-IGG test was positive at 242 (positive range: >20). CMV antibody collected on 08Jan04 was neg. Lyme screen IGG/IGM completed on 13Jan04 was negative. Hep A antibody HV was positive.	UNK	UNK	Aspirin, Flomax, Nyquil		The pt had previously received influenza vaccines in 1999 and 2001. His preexisting medical conditions included coronary artery disease with Angioplasty x 1 and benign prostatic hypertrophy. Past surgical history was positive for hernia repair. The pt had no known allergies.		200401021	1						1	Asthenia; Atelectasis; Atherosclerosis; Difficulty in walking; Extensor plantar response; Guillain-Barre syndrome; Hypokinesia; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U1131AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0231531	12/28/2004	PA	61.0	60		F	04/29/2004	From initial information received on 22Oct03 from a health care professional regarding an adverse event occurring, it was reported that a 61 year old female pt received a dose of Fluzone SV 2003-2004 USP, lot number U1137HA, administered IM in the left deltoid on 10Oct03 at 11:30AM. Eight days later, on 18Oct03, the pt developed pain in both axillary areas. The areas were sensitive to touch. Reportedly the pt recovered from this event. From additional information received on 05Feb04 from a health care professional, it was reported that no additional information was available for this case at this time. No further information is anticipated, this case is considered closed.									Y	10/10/2003	10/18/2003	8	NONE	UNK	OTH		NONE			200301752	1						1	Injection site pain	FLU3~SANOFI PASTEUR~U1137HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231532	12/28/2004	PA	46.0	46		F	01/29/2004	From initial information received on 25Sep03 from a health care professional regarding an adverse event occurring, it was reported that a 46 year old female pt received a dose of Fluzone, lot number U1139AA, expiration date 30Jun04, administered in the right deltoid on 22Sep03. On the same day, the pt's arm became red and swollen. The pt was seen by a physician and it was noted that the area of redness and swelling measured 6.5 inches in diameter. The pt was treated with Benadryl and ice packs to treat the reaction and reportedly the area has decreased in size. The pt's recovery status is currently unk. From additional information received on 19Nov03 from a health care professional, it was reported that the vaccine was administered IM. No other medical information was provided at this time. No further information is anticipated, this case is considered closed.				Y					U	09/22/2003	09/22/2003	0		PVT	UNK					200302194	1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1139AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231533	12/28/2004	NC	41.0	40		F	10/17/2003	From initial information received on 10/01/03 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 40 year old female patient received her first dose of Fluzone, lot number U1141AA, expiration date 06/30/04, administered in the left deltoid on 9/29/03. 24 hours later, the patient developed a 3.5 x 6 cm oval red area, which was sore and had mild itching. She was prescribed Atarax for the itching and cool soaks. Reportedly, the patient stated that she was light headed and felt groggy. The patient's recovery status was not reported.									U	09/29/2003	09/30/2003	1		UNK	UNK					200302225	1						1	Dizziness; Injection site erythema; Injection site pain; Pruritus; Somnolence	FLU3~SANOFI PASTEUR~U1141AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231534	12/28/2004	TX				F	10/20/2003	From initial information received on 10/06/03 from a health care professional regarding an adverse event occurring in the U.S.A, it was reported that a female patient (age and birth date not reported) received Fluzone SV '2003-'2004 USP, lot number U1260AA, administered intra-muscularly (site of administration not reported) on 10/03/03. The following day, the patient developed pain, edema, redness, and itching at the injection site, as well as pain and swelling in her joints. The patient's recovery status was not reported. The reporter of this case is the same reporter of cases 200302255, 200302256, and 200302258.								Y	U	10/03/2003	10/04/2003	1		OTH	PVT	None stated.	None stated.	None stated.		200302253	1						1	Injection site erythema; Injection site oedema; Injection site pain; Pruritus	FLU3~SANOFI PASTEUR~U1260AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0231535	12/28/2004	TX				F	10/20/2003	From initial information received on 10/06/03 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a female patient (age and birth date not reported) received Fluzone SV '2003-'2004 USP, lot number U1260AA, administered intra-muscularly in the right arm on 10/03/2003. The following day the patient developed redness and edema at the injection site, as well as itching, fever, aching, nausea, and pain and swelling in her joints. The patient's recovery status was not reported. The reporter of this case is the same reporter of cases 200302253, 200302256, 200302257 and 200302258.									U	10/03/2003	10/04/2003	1		OTH	PVT		None stated.	None stated.		20030225	1						1	Arthralgia; Injection site erythema; Injection site oedema; Joint swelling; Pain; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~U1260AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231536	12/28/2004	TX				M	10/16/2003	From initial information received on 10/06/03, from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a female patient (age and date of birth not reported) received Fluzone SV '2003-'2004 USP, Lot number U1260AA, administered intra-muscularly (site of administration not reported) on 10/03/03. One day later, the patient developed redness, edema, and itching at the injection site, as well as fever, aching, joint pain and joint swelling. The patient's recovery status was not reported. The reporter of this case is the same reporter of cases 200302253, 200302255, 200302257 and 200302258.									U	10/03/2003	10/04/2003	1		OTH	PVT		None stated.	None stated.		200302256	1						1	Arthralgia; Injection site erythema; Injection site oedema; Joint swelling; Pain; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~U1260AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231537	12/28/2004	TX				F	10/17/2003	From initial information received on 10/06/03 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a female patient (age and birth date not reported) received Fluzone SV '200-'2004 USP, lot number U1260AA, administered intra-muscularly (route and site not reported) on 10/03/03. The following day, the patient developed pain, edema, redness, and itching at injection site, as well as fever, achiness, and pain and swelling in her joints. The patient's recovery status was not reported. The reporter of this case is the same reporter of cases 200302253, 200302255, 200302256, and 200302258.									U	10/03/2003	10/04/2003	1		OTH	PVT		None stated.	None stated.		200302257	1						1	Arthralgia; Injection site erythema; Injection site oedema; Injection site pain; Joint swelling; Pain; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~u1260AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231538	12/28/2004	TX	48.0	48		F	10/17/2003	From initial information received on 10/06/03 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 48 year old female patient received her first does of Influenza Virus Vaccine, lot number U1260AA, administered intra-muscularly in the right arm on 10/03/03.The following day, the patient developed redness and edema at injection site, itching, pain and swelling in joints, as well as fever, aching, and nausea. The patient's recovery status was not reported. The reporter of this case is the same reporter of cases 200302253, 200302255, 200302256 and 200302257.									U	10/03/2003	10/04/2003	1		UNK	UNK		None stated.	None stated.		200302258	1						1	Arthralgia; Injection site erythema; Injection site oedema; Joint swelling; Nausea; Pain; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~U1260AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231539	12/28/2004	CT	55.0	55		F	01/29/2004	From initial information received on 10/09/03, from a health care professional, regarding an adverse event occurring in the U.S.A., it was reported that a 55 year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1089AA, given intra muscularly in the left arm on 10/04/03. The following day, 10/05/03, the patient developed a rash at the injection site as well as on both legs. The recovery status was reported as unknown. This is the same reporter as case 200302313. From additional information received on 11/18/03, from a health care professional, it was reported that the patient also developed a rash on her stomach, legs and chest. The rash was not itchy and the patient was fine otherwise and she did not seek medical care. The rash cleared after one week and the patient recovered. No further information is anticipated, this case is considered closed.									Y	10/04/2003	10/08/2003	4		PUB	PVT		NONE	The patient had received influenza vaccines in previous years without any adverse events.		200302312	1						1	Injection site rash; Rash	FLU3~SANOFI PASTEUR~U1089AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231540	12/28/2004	CT	56.0	55		M	01/29/2004	From initial information received on 10/09/03, from a health care professional, regarding an adverse event occurring in the U.S.A., it was reported that a 55 year old male patient received Fluzone SV '200-'2004, lot number U1089AA, given intra muscularly in the left arm on 10/03/03. The following day, on 10/04/03, the patient developed a rash on his back, buttocks and on both legs. the recovery status was reported as unknown. The reporter of this case is the same reporter for case 200302312. From additional information received on 11/18/03 from a health care professional, the patient had been taking prednisone 50 mg two weeks before immunization. The patient was seen by his primary care physician on 10/09/03 who prescribed Allegra and Hydrocortisone for the rash, which was all over the patient's body. The patient was feeling a little better at the time. On 11/13/03, the health care provider spoke with the patient, who stated that his primary physician had diagnosed him with shingles. It is unknown if the patient recovered. No further information is anticipated, this case is considered closed.				Y					U	10/03/2003	10/04/2003	1		PUB	PVT		NONE	The patient had been taking prednisone 50 mg two weeks before immunization. He received the in previous years with no adverse events.		200302313	1						1	Herpes zoster; Infection; Rash	FLU3~SANOFI PASTEUR~U1089AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231541	12/28/2004	MA	42.0	42		F	10/16/2003	From initial information received on 10/10/03, from a health care professional regarding an adverse event occurring in the USA, it was reported that a 42 year old female patient received a dose of Fluzone, lot number U1139AA, administered intra-muscularly in the left arm on 10/07/03. Two days later, the patient developed a 2 inch red area, swollen and warm at the administration site as well as fever, nausea and vomiting. During this event, the patient was also taking Glucophage, Acupril and HCTZ. The patient's recovery status is unknown.									U	10/07/2003	10/09/2003	2		PVT	UNK	Glucophage, Acupril, HCTZ	Denies	Denies		200302337	1						1	Injection site erythema; Injection site swelling; Injection site warmth; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1139AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231542	12/28/2004	PA	45.0	44		F	03/11/2004	From initial information received on 10/13/03, from a health care professional regarding an adverse event occurring in the USA, it was reported that a 44 year old female patient received her first dose of Influenza Virus vaccine, lot number U1137HA, administered intra-muscularly in the left deltoid on 10/10/03 at 3:45 pm. Twenty two  minutes later, the patient developed rash on the upper body, warm and clammy skin, generalized itching, and an itchy throat. The patient received Benadryl and Prednisone, after which she immediately recovered. The patient is allergic to pollen, pet dander and PCN. From additional information received on 11/24/03, from a health care professional, it was reported that the patient had not previously received any influenza vaccine. Following the adverse events the patient was referred to her private physician. No other information was provided at this time. Further information is not anticipated, this case is considered closed.									U	10/10/2003	10/10/2003	0	NONE	OTH	OTH	Nasonex, Progesterone, Advair, Ranitidine, Benadryl, Prednisone	NONE	Allergy to pollen, pet dander and PCN. The patient had not previously received an influenza vaccine.		200302347	1						1	Cold sweat; Feeling hot; Pruritus; Rash; Respiratory disorder	FLU3~SANOFI PASTEUR~U1137HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231543	12/28/2004	IN	66.0	66		F	10/20/2003	From initial information received on 10/15/03, from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 66 year old female patient received Fluzone SV '2003-'2004 USP, lot number U1266AA, administered intra-muscularly in the left deltoid on 10/10/03. Four days later, the patient developed radiating pain in the left arm and shoulder. She was seen in the emergency room and treatment included Celebrex and a heart attack was ruled out as per the reporter. Reportedly, the patient's recovery status is currently unknown.				Y					U	10/10/2003	10/14/2003	4	Unknown per reporter	PVT	UNK	Lipitor and Celebrex	NONE	The patient has allergies to codeine and Darvon. Additionally she has a history of arthritis and hyperlipidemia, for which she takes Lipitor 10 mg. daily.		200302385	1						1	Pain	FLU3~SANOFI PASTEUR~U1266AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231544	12/28/2004	NY	50.0	49		F	01/22/2004	From initial information received on October 15,2003 from the patient regarding an adverse event occurring in the USA, it was reported that a female patient (age and birth not reported) received Fluzone SV '2003-2004' UPS, lot number U1097AA, administered intra-muscularly in the left deltoid on October 09,2003.  One day later, the patient developed a fever, chills, general malaise, and flu-like symptoms.  The patient was prescribed Tylenol and advised to force fluids.  The patient's medical conditions include immunosuppression and at the time of vaccination the patient had a compromised immune system.  Reportedly, the patient recovered from this event. From additional information received on 01/14/2004 from the responsible physician, it was reported that the patient received the Fluzone SV '2003-2004' vaccination on October 02,2003, not October 09,2003 as previously reported.  Additionally, the adverse event onset date was updated to October 03,2003, not October 10,2003 as previously reported.  The patient's date of birth and contact information were also provided.									Y	10/02/2003	10/03/2003	1		PVT	UNK		Compromised immune system.	Immunosuppressed.		200302387	1						1	Immune system disorder; Influenza like illness; Malaise; Pyrexia	FLU3~SANOFI PASTEUR~U1097AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231545	12/28/2004	PA	51.0	51		F	04/29/2004	From initial information received on October 20,2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a female patient (age and birth date not reported) received a dose of Fluzone SV '2003-'2004 USP, lot number U1137HA, on October 02,2003 at 4:15PM (route and site of administration not reported). On October 03,2003 at 9:00AM, the patient developed left shoulder pain with movement.  The patient's recovery status is currently unknown. From additional information received on 11/17/2003 from the initial reporter, it was reported that the vaccine was administered intra-muscularly in the left deltoid.  Treatment included Aleve three times a day as occasion as needed and Icy Hot to the shoulder.  No relevant diagnostic tests were performed at this time.  The patient is still under a doctor's care and is being treated for possible mild to moderate subacromial bursitis.  No other information reported at this time. Further information is not anticipated, this case is considered closed.				Y					U	10/02/2003			None at this time.	OTH	OTH	Clamaria, Estrogen, Vitamins	NONE	NONE		200302562	1						1	Bursitis; Pain	FLU3~SANOFI PASTEUR~U1137HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231548	12/28/2004	TX	37.0	37		M	10/23/2003	From initial information received on October 10,2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 37 year old male patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1253AA, expiration date June 30,2004, administered in the right deltoid (route of administration not reported) on October 17,2003 at 9:00AM.  At 11:00AM of the following day, the patient developed soreness in the right axilla down to the chest wall with edema.  The patient was recommended to use ice packs.  The patient's recovery status is currently unknown.									U	10/17/2003	10/18/2003	1		UNK	UNK					200302662	1						1	Chest pain; Oedema	FLU3~SANOFI PASTEUR~U1253AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231549	12/28/2004	IL	60.0			M	01/29/2004	From initial information received on October 17,2003 from a patient, who is a physician, regarding an adverse event occurring in the USA.  It was reported that he received a dose of Fluzone SV '2003-'2004 USP on October 2, 2003, route and site of administration not reported.  An unspecified time after vaccination, the patient developed brachial plexus neuropathy and skin pain in the chest, neck, and back area. From additional information received on 11/20/2003 through a telephone call to the patient, who is a physician, it was reported that the onset of the symptoms began with a left sided sore throat, ear ache, and tenderness of the skin over the left clavicle and left breast.  The patient developed a bump on his left shoulder and was treated with acyclovir.  He was seen by a neurologist and the neurological work-up was within normal limits.  A C-spine and MRI of the spine were performed and were within normal limits for a 60 year old male.  The patient also stated that he fully recovered from these events on 11/11/2003.  No other information was provided. No further information is anticipated, this case is considered closed.				Y					Y	10/02/2003			Neurological work-up was within normal limits.  A C-spine and MRI of the spine were performed and were within normal limits for a 60 year old male.	UNK	UNK		Recent tooth abscess.			200302668	1						1	Back pain; Breast pain; Chest pain; Ear pain; Neck pain; Neuropathy; Pharyngolaryngeal pain; Skin nodule	FLU3~SANOFI PASTEUR~U1142AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231550	12/28/2004	TN	44.0	44		F	11/05/2003	From initial information received on 22OCT2003 from a health care professional regarding an adverse event occuring in the USA, it was reported that a 44 year old female patient received a dose of FLUZONE 2003-2004, administered IM in the left deltoid on 20OCT2003. The following day, the patient developed left eye angioedema, left earache and a sore throuat. The patient was treated with Benadryl 25mg orally , two doses given. Reportedly,t the events fully resolved.									Y	10/20/2003	10/21/2003	1		UNK	UNK					200302979	1						1	Angioneurotic oedema; Ear pain; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U1099AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231552	12/28/2004	ME	47.0	47		M	12/15/2003	From initial information received on 24OCT2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 47 year old male patient received a dose of FLUZONE administered IM in the left deltoid on 22OCT2003 at 4:00pm. The next day, at 6PM , the patient developed a pruritic rash on his trunk , arms and neck. No respiratory or neurologic symptoms were present. The patient was prescribed Benadryl 25mg one to two every six hours as necessary for itching. It is not known whether the patient recovered.									U	10/22/2003	10/23/2003	1		UNK	UNK			The patient last received the influenza vaccine nine years ago and had no adverse reaction.		200302719	1						1	Rash pruritic	FLU3~SANOFI PASTEUR~U1269AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231554	12/28/2004	NY	57.0	57		F	12/02/2003	From initial information received on 24OCT2003 from a physician regarding an adverse event occurring in the USA it was reported that a 57 year old female received a dose of FLUZONE, administered IM in the right deltoid on 21OCT2003. The following day, the patient developed a local reddened area at the injection site. She was seen by a physician the next day. At that time, the patient had a 15cm x 15cm indurated area at the site and a red macular rash on her upper extremities and torso. She also reported slight pruritus. The patient had not recovered from these events at the time of this report.				Y					N	10/21/2003	10/22/2003	1		PVT	PVT	Depakote, Diovan, Flexeril, Lasix, Lopid, Nexium, Synthroid, Wellchol				200302721	1						1	Injection site erythema; Injection site induration; Pruritus; Rash macular	FLU3~SANOFI PASTEUR~U1144AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231556	12/28/2004	TN	40.0	40		F	12/15/2003	Generalized rash From initial information received on 10/27/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 40 year old female patient received a dose of FLUZONE SV '2003-'2004 USP, lot number U1267AA, administered in the right deltoid (route not reported) on 10/14/2003 at 01:30 PM. Half a hour later, the patient developed a rash on the right side of her body, leg, arm and face. She was treated with allerga and hydroxyzine 20mg. intra-muscularly. Reportedly, the patient recovered from this event. The reporting facility for this case is the same as for case 2003-02792.									Y	10/14/2003	10/14/2003	0		PVT	UNK					200302793	1						1	Rash	FLU3~SANOFI PASTEUR~U1267AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231557	12/28/2004	NE	64.0	64		F	11/07/2003	Papular rash Pruritic rash Redness From initial information received on 10/28/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 64 year old female patient received a dose of FLUZONE SV '2003-'2004 USP,  lot number U1123AA, administered intra-muscularly in the left deltoid on 10/21/2003 at 12:15 PM. Within 2 hours of receiving the vaccination, the patient developed an itching rash. There was no swelling or breathing difficulty. The following day at 10:56 AM, the rash pruritic, scattered, raised and red. It was described as papular with a reddish border (about 20 papules in total). The affected areas were the upper body, arms, chest and back. There was no typical hives or urticaria. The patient was treated with benadryl and caladryl lotion for itching. The patient has had influenza shots in the past with no previous reactions. She has had similar rashes in the past, but only from oral medications including penicillin, sulfa and morphine and these were described as blotches further apart - hives. Reportedly, the patient recovered from these events.									Y	10/21/2003	10/22/2003	1		OTH	OTH	AVAPRO, LIPITOR, PREMARIN, PROPANTHELINE< TOPROL XL, VIOXX		The patient has had similar rashes in the past from oral medications only, including penicillin, sulfa, and morphine. These reactions consisted of blotches that were further apart - hives as per reporter. She has had flu shots since they were on the market with no previous reactions. The patient had been dieting prior to receiving the vaccine and lost 23 lbs.		200302796	1						1	Erythema; Rash papular; Rash pruritic	FLU3~SANOFI PASTEUR~U1123AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231558	12/28/2004	WA	38.0	38		F	12/15/2003	Dizziness From initial information received on 10/28/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 38 year old female patient received a dose of FLUZONE SV '2003-'2004 USP, lot number U1132AA, administered intra-muscularly in the left deltoid on 10/28/2003. Within three minutes of vaccination, the patient felt dizzy and light headed and fell to the floor. She was taken to the emergency room via wheelchair. The patient's recovery status is currently unknown.				Y					U	10/28/2003	10/28/2003	0		UNK	UNK	DEPAKOTE, MAXALT		History of asthma. Concomitant medications included Depakote and Maxalt for migraines.		200302799	1						1	Dizziness	FLU3~SANOFI PASTEUR~U1132AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231559	12/28/2004	NC	52.0	51		F	11/13/2003	Facial swelling - Swollen eyes Hives Rash Pruritis From initial information received on 10/29/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 51 year old female patient received a dose of FLUZONE SV '2003-'2004 at 10:40 AM. 19 hours later, the patient developed facial swelling, swollen eyes and a hive around her chin, neck and nose. The patient had no respiratory problems. She developed a rash on her chin after the hives resolved and also experienced itching. She took Benadryl and used hydrocortisone cream to treat the symptoms. The patient's physician prescribed Zyrtec. On 10/28/2003 the patient still had some facial swelling, but this symptom was resolving. The reporter of this case is the same reporter of case U1998-00297.									N	10/24/2003	10/25/2003	1		OTH	PVT	AVALIDE, GLUCOVANCE, LEVOXINE, PRAVCHOL		Allergic to Iodine.		200302820	1						1	Eye swelling; Pruritus; Rash; Swelling face; Urticaria	FLU3~SANOFI PASTEUR~U1135EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231560	12/28/2004	IA	35.0	34		F	01/30/2004	From initial information received on 29OCT2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 36 year old female patient received a dose of FLUZONE administered in the left deltoid on 27OCT2003. The following day,the patient woke up with body aches, fatigue, a temperature of 101 degrees Fahrenheit, stomach cramps, nausea and diarrhea. The patient's recovery status is currently unknown. The reporter of this case is the same reporter of case U2001011283.									U	10/27/2003	10/28/2003	1		UNK	UNK			The pt had received the influenza vaccine in the past.		200302821	1						1	Abdominal pain; Diarrhoea; Fatigue; Nausea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1092AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231561	12/28/2004	MN	40.0	39		F	11/07/2003	From initial information received on 29OCT2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 39 year old female patient received a dose of FLUZONE administered IN on 27OCT2003. Bout 15 minutes later, the pt experienced swelling of the hands, weakness,hives and idaphoresis. The pt was given Benadryl IM and ice packs were applied to the injection stie. The patient rested for 45 minutes and the events fully resolved. The patient recovered from these events.				Y					Y	10/27/2003	10/27/2003	0		UNK	UNK			Allergy to bee stings		200302823	1						1	Asthenia; Hyperhidrosis; Oedema peripheral; Swelling; Urticaria	FLU3~SANOFI PASTEUR~U1123AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231562	12/28/2004	TX	78.0	78		F	04/29/2004	From initial information received on 30OCT2003 from an MD regarding an adverse event occurring in the USA, it was reported that a 78 year old female patient received a dose of FLUZONE on 18OCT2003. The route and site of administration were not reported. Three days later , on 21OCT2004. the patient developed a bitemporal, persistent , severe headache. She also had throbbing in her inner ears. A CAT scan was within normal limits. The pt's recovery status is unk.									U	10/18/2003	10/21/2003	3	CAT: WNL. Sedimentation rate and CBC: no results reported.	UNK	UNK					200302848	1						1	Ear pain; Headache	FLU3~SANOFI PASTEUR~U1079AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231563	12/28/2004	PA	4.0	4		M	02/13/2004	From initial information received on 10/30/2002 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a four year old male patient received FLUZONE SV '2003-'2004 USP, lot number U1268AA, administered intramuscularly in the left arm on 10/27/2003. Two days later, on 10/29/2003, the patient's entire left arm was swollen, red and itchy. The patient was seen by a physician. At the time of this report, the patient had not recovered from these adverse events. From additional information received on 02/12/2004 from the reporting physician, a correction to the patient's name was provided, as well as his address, birth weight and number of siblings. Per the physician there is no additional information for this case. No further information is anticipated, this case is considered closed.				Y					N	10/27/2003	10/29/2003	2		PVT	UNK	DEPAKOTE	Ear infection	The patient has a history of cardiac insufficiency, tetralogy of Fallot and seizure disorder		200302849	1						1	Injection site erythema; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U1268AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231565	12/28/2004	IA	55.0	55		F	06/29/2004	Muscle ache Fever Sore throat Postnasal drip From initial information on 11/04/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 55 year old female patient received a dose of FLUZONE SV '2003-'2004 USP, lot number U1135FA, administrated in the left deltoid on 10/16/2003. The reporter stated that the vaccine was administered with a 5/8 inch needle and may have been given subcutaneously. The following day, the patient developed a sore throat and muscle aches in her shoulder and neck. She also experienced a temperature of 99.1 degrees fahrenheit which lasted for three days, as well as postnasal drip. The patient self-medicated with Ibuprofen and Tylenol and visited a chiropractor for the muscle aches. Reportedly, the symptoms resolved and returned on 10/30/2003. It was not reported whether the patient recovered. From information received on 04/23/2004 from a health care professional, it was reported that the information has been reviewed and no additional information is available. The recovery status was erroneously checked as yes in version 0 but was corrected in version 1. No further information is anticipated, this case is considered closed.									U	10/16/2003	10/17/2003	1		PVT	UNK	FLONASE, HIGH BLOOD PRESSURE PILL		History of hypertension and chronic rhinitis.		200302896	1						1	Myalgia; Pharyngolaryngeal pain; Postnasal drip; Pyrexia	FLU3~SANOFI PASTEUR~U1135FA~2~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231566	12/28/2004	IL	48.0	47		F	11/07/2003	From initial information received on 11/04/2003 from a physician regarding an adverse event occurring in the U.S.A., it was reported that a 47 year old female patient received a dose of FLUZONE SV '2003-'2004 USP, lot number U1123AA, administered intra-muscularly in the left deltoid on 11/03/2003 at 1:55 PM. The patient had received the influenza vaccine four times in the past. Two hours after receiving the vaccine on 11/03/2003, the patient developed body itching. The patient inspected her skin approximately a half hour later and found three red, raised, circular areas with white centers measuring about one inch in diameter. She took one dose of Benadryl 25 mg. and awoke the next morning at 6:00 AM with swollen hands and knees. She was seen by the reporting physician the following day at 9:00 AM and the hand swelling was gone. It was noted that she had three red papules measuring approximately 1.5 cm, which she treated with topical Benadryl. The papules were located on her medial thigh, left hip and left neck. The physician stated that the patient did not have any difficulty breathing or anaphylaxis with these events. Reportedly, the patient recovered from these events.				Y					Y	11/03/2003	11/03/2003	0		PVT	UNK			Allergies to amoxicillin, Macrodantin, bee stings, mold, pollen and soap.		200302897	1						1	Pruritus; Rash papular; Swelling	FLU3~SANOFI PASTEUR~U1123AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231567	12/28/2004	NH	33.0	32		F	04/28/2004	From initial information received on 11/05/2003, from a health care professional regarding an adverse event occurring in the USA, it was reported that a 32 year old female patient received a dose of Fluzone SV '2003-'2004 USP (lot number U1102AA, expiration date 6/30/04) administered on 10/04/03. The route and site of administration were not reported. Within 24 hours, the patient developed a fever of 102 degrees Fahrenheit with malaise, fatigue and cervical lymphadenopathy. The next day, the patient still had a fever of 100 degrees Fahrenheit and was seen by a physician, who recommended Motrin 600mg, every 6 hours. the patient reportedly has received numerous influenza vaccines in the past. Her recovery status is unknown. From additional information received on 02/11/04 from a health care professional, the county of vaccination was reported. The vaccine was administered intra muscularly in the left deltoid on 11/04/03, not 10/04/03, as initially reported. The adverse event onset date was 11/05/03. the symptoms lasted for 72 hours. Reportedly, the patient purchased the vaccine with private funds. No relevant diagnostic tests were preformed. The patient did require a doctor's office visit due to the symptoms. She did not have any illnesses present at the time of vaccination. Reportedly, the patient recovered from these events. Her full address and telephone number were also provided. No further information is anticipated, this case is considered closed.				Y					Y	11/04/2003	11/05/2003	1	NONE	OTH	PVT	Motrin	NONE	The patient reportedly has received numerous influenza vaccine in the past.		200302913	1						1	Fatigue; Lymphadenopathy; Malaise; Pyrexia	FLU3~SANOFI PASTEUR~U1102AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231568	12/28/2004	NY	78.0	77		M	12/02/2003	From initial information received on 11/07/03, from a physician regarding an adverse event occurring in the USA, it was reported that a 77 year old male patient received a dose of Fluzone SV '200-'2004, lot number U1089AA, administered intra muscularly (site not reported) on 10/27/03. Three days late, on 10/30/03, the patient developed a headache, fever and fatigue. A purpuric rash was noted on his lower legs below his knees. The physician ordered blood tests, which showed a normal white blood cell count, decreased platelets and an increased sed rate. The patient contiues with the purpuric rash and complaints of headache, fatigue and low grade fever. Reportedly, the events have not resolved.				Y					N	10/27/2003	10/30/2003	3	Platelet count - decreased, Sed rate - increased, WBC within normal limits.	PVT	PVT	Zocor	Denies	No known allergies. The patient has a history of prostate cancer, hyperlipidemia and benign tremors.		200302923	1						1	Fatigue; Headache; Laboratory test abnormal; Purpura; Pyrexia	FLU3~SANOFI PASTEUR~U1089AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231569	12/28/2004	NC	3.0	3		M	11/21/2003	From initial information received on 11/07/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 3 year old male patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1131AA, route and site of administration not reported, on 11/05/2003.  Two days later, the patient developed erythema mulitforme.  No other reactions were reported by the physician.  The patient's recovery status is unknown.				Y					N	11/05/2003	11/07/2003	2	Unknown.	PVT	PVT		Denies.	No known allergies or medical conditions.		200302927	1						1	Erythema multiforme	FLU3~SANOFI PASTEUR~U1131AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231570	12/28/2004	VA	12.0	11		M	11/21/2003	From initial information received on 11/07/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that an 11 year old male patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1097AA, administered intra-muscularly in the left deltoid on 11/06/2003.  Immediately after receiving the vaccination, the patient developed wheezing and numbness in the left arm down to the wrist.  Treatment included Albuterol via hand held nebulizer.  The symptoms resolved within 15 minutes and the patient was observed for 45 minutes.  The patient was to follow up with an allergist.  The patient recovered from these events.									Y	11/06/2003	11/06/2003	0	NONE	UNK	UNK		Urinary retention.	NONE		20030298	1						1	Hypoaesthesia; Wheezing	FLU3~SANOFI PASTEUR~U1097AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231571	12/28/2004	NY	6.0	5		F	01/13/2004	From initial information received on 11/10/2003 from a physician regarding an adverse event occurring in the USA, it was reported that a 5 year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1131AA, administered intra-muscularly in the right deltoid on 10/23/2003.  48 hours later, the patient developed Raynauds of both feet and hands.  The patient has a history of egg allergy which reportedly resolved.  At the time of this report ANA, metabolic panel and thyroid testing had been completed (no results provided) and the patient was continuing to undergo tests to determine etiology.  Reportedly, the patient did not recover from this event.									Y	10/23/2003	10/25/2003	2	ANA, metabolic panel and thyroid testing had been completed (no results provided) and the patient was continuing to undergo tests to determine etiology.	PVT	UNK	Albuterol inhaler, Claritin, Singular	Asthma	History of egg allergy, which was reported as having been resolved.		200302953	1						1	Hypersensitivity; Raynaud's phenomenon	FLU3~SANOFI PASTEUR~U1131AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231572	12/28/2004	IN	25.0	25		F	04/28/2004	From initial information received on 11/10/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 25 year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1255AA, administered in the left deltoid (route of administration not reported) on 11/06/2003 at 3:20PM.  Approximately six hours later, the patient developed a fever with a temperature of 101 degrees Fahrenheit.  She had chills and felt cold, weak and was shaky.  Both of her arms were red from the shoulder to the wrist area.  The patient took Tylenol and went to sleep.  She awok in the morning with continued weakness and arm redness.  The reporter spoke with the patient on 11/10/2003 and the symptoms were gone.  The patient recovered from these events. From additional information received on 12/11/2003 from a nurse.  It was reported that the patient received the vaccine intra-muscularly in the left deltoid.  Other medications during vaccination included multivitamin.  The patient has previously received the influenza vaccine without any indicents.  There were no diagnostic tests performed.  The patient's medical history includes dizziness.  Otherwise the patient is healthy and has not allergies.  No other information was provided at this time.  No further information is anticipated, this case is considered closed.									Y	11/06/2003	11/06/2003	0		PUB	PVT	Mulitvitamins	NONE	Dizziness, otherwise healthy.  No allergies.		200302954	1						1	Erythema; Muscular weakness	FLU3~SANOFI PASTEUR~U1255AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231573	12/28/2004	LA	1.0	1	.0	F	01/13/2004	From initial information received on 11/11/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a one year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1095AA, administered intra-muscularly in the right thigh on 11/07/2003.  30 minutes later, the patient developed a generalized rash.  Oral Benadryl was given and the reaction was gone within one hour.  The patient recovered from  this event.									Y	11/07/2003	11/07/2003	0		UNK	UNK		NONE	NONE		200302964	1						1	Rash	FLU3~SANOFI PASTEUR~U1095AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231575	12/28/2004	MI	19.0			F	04/29/2004	From initial information received on 11/12/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that 19 year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number not reported, administered in her deltoid (route of administration not reported), on an unspecified date.  According to patient's mother, the patient complained of arm pain beginning the evening of injection.  The arm pain has resolved, but shoulder pain persists.  The patient's primary care physician made a diagnosis of bursitis.  Reportedly, the patient did not recover from these events.  No other information was provided at this time. Follow up VAERS form received on 02/23/2004.  No additional information was provided. No further information is anticipated, this case is considered closed.				Y					U					UNK	UNK					200302984	1						1	Bursitis; Pain	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231576	12/28/2004	PA	56.0	56		F	01/06/2004	From initial information received on 11//11/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 56 year old female patient received a dose of Fluzone SV '2003-2004' USP, lot number U1139AA, administered intra-muscularly in the left deltoid on 11/11/2003 at 10:00AM.  One hour and 15 minutes later, the patient developed local tenderness and swelling at the site, which measured approximately 7 to 10 cm in diameter.  The site was very warm.  The patient also complained of dizziness.  She denied shortness of breath initially after receiving the vaccine, but complained of it three hours later.  The patient used an inhaler, which relieved the symptoms.  At the time of this report the patient had not recovered.									N	11/11/2003	11/11/2003	0		OTH	OTH	Allergy medications vitamins zestoric	Denied	History of high blood pressure asthma allergies to molds, pollen, buckwheat ant tetanus.		200302985	1						1	Dizziness; Dyspnoea; Feeling hot; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1139AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231580	12/28/2004	TX	47.0	46		M	04/29/2004	Swelling of face Rash Itching From initial information received on 11/17/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 46 year old male patient received a dose of FLUZONE SV '2003-'2004 USP, lot number U1095AA, administered intra-muscularly in the right deltoid on 10/11/2003. Within one hour of vaccination, the patient developed facial swelling, itching and rash on the upper trunk and face. Reportedly, the patient did not recover from these events. It was reported that the patient is allergic to the flu vaccine. From additional information received on 02/25/2004 from the initial reporter, it was reported that the patient did not receive any other vaccines within four weeks of receiving FLUZONE SV '2003-2004 USP. Reportedly, the patient recovered from these events. No further information is anticipated, this case is considered closed.									Y	10/11/2003	10/11/2003	0		OTH	OTH		End stage renal disease	It was reported that the patient is allergic to the flu vaccine.		200303180	1						1	Face oedema; Pruritus; Rash	FLU3~SANOFI PASTEUR~U1095AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231581	12/28/2004	MD	39.0	38		F	12/02/2003	Shortness of breath Chest pain Dizziness Generalized rash Muscle pain From initial information received on 11/20/2003 from a registered nurse regarding an adverse event occurring in the U.S.A., it was reported that a 38 year old female patient, after having had an unspecified reaction to the 'flu vaccine' the previous year, received FLUZONE SV '2003-'2004 USP in two 0.25 ml. split doses. She received the first dose, lot number not reported, administered intra-muscularly in the left deltoid on 10/24/2003. Sometime after the first injection, the patient developed local redness and tenderness at the injection site. The patient received her second dose, lot number U1089AA, administered intra-muscularly in the left deltoid on 11/07/2003. Three days after receiving the second dose, on 11/10/2003, the patient complained of shortness of breath, chest pain, muscle pain in her left arm, dizziness and generalized red rash. The patient was evaluated by a doctor. The reporter stated that the condition has resolved, but she unsure of the exact timing of the events.				Y					Y	11/07/2003	11/10/2003	3		UNK	UNK			The patient had an unspecified reaction to the flu vaccine last year.	Injection site redness, tenderness~Influenza (Seasonal) (no brand name)~~38.00~In Patient	200303201	1						1	Chest pain; Dizziness; Dyspnoea; Injection site erythema; Myalgia; Rash; Tenderness	FLU3~SANOFI PASTEUR~U1089AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231582	12/28/2004	WV	46.0	45		F	12/02/2003	Ache Fever Shortness of breath Hives From initial information received on 11/21/2003 from a health care professional, regarding an adverse event occurring in U.S.A., it was reported that a 45 year old female patient received FLUZONE SV '2003-'2004 USP, lot number U1139AA, administered intramuscularly in the left deltoid on 10/14/2003. The next day, on 10/15/2003, the patient developed a fever of 102 degrees Fahrenheit, shortness of breath and body aches. The patient took Advil and was fine. On 10/18/2003, the patient developed hives, but was already on Claritin. The patient informed the office on 10/27/2003 that the hives resolved on an unspecified date. The patient has recovered from these events.									Y	10/14/2003	10/15/2003	1		PVT	UNK	Claritin, multivitamin, Synthroid		Hypothyroidism and chronic rhinitis. The patient last received an influenza vaccine 30 years ago per the reporter.		200303211	1						1	Dyspnoea; Pain; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U1139AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231584	12/28/2004	WA	11.0	10		M	06/29/2004	Throat tightness Diaphoresis Pale From initial information received on 12/01/2003 from a physician regarding an adverse event occurring in the USA, it was reported that a ten year old male patient received a dose of FLUZONE SV '2003-'2004 USP, lot number U1098AA, route and site of administration not reported, on 11/29/2003. Within ten minutes after vaccination, the patient developed diaphoresis, pale color and felt like his throat was closing. No shortness of breath. The symptoms resolved before paramedics arrived. The patient's pre-existing medical history includes migraines, headaches and ADD. At the time of vaccination he was also taking Concerta. Reportedly, the patient recovered from these events. From additional information received on 04/27/2004 from the initial reporter, the patient's full name was provided. It was reported that the patient experienced symptoms approximately five minutes after vaccination. Reportedly, the patient was vaccinated at a private doctor's office/hospital. No further information is anticipated, this case is considered closed.									Y	11/29/2003	11/29/2003	0		PVT	OTH	Concerta		Migraines, headaches, Attention Deficit Disorder (ADD)		200303282	1						1	Hyperhidrosis; Pallor; Throat tightness	FLU3~SANOFI PASTEUR~U1098AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231585	12/28/2004	TX	3.0	3		M	03/11/2004	Stomach pain Vomiting From initial information received on 03/Dec/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a three-year-old male patient received his first dose of Fluzone SV 2003-2004 USP, lot number U1092AA, administered intra-muscularly (site not reported) on the afternoon of 02/dec/2003.  That evening, the child developed severe stomach pain and vomiting.  At the time of this report, the symptoms were still persisting.  The patient's pas medical history is significant for asthma and egg allergy.									N	12/02/2003	12/02/2003	0		PVT	PVT	Histussin HC, Singular	Seen on 01/Dec/2003 with cough and congestion.	Egg allergies, asthma.		200303300	1						1	Abdominal pain upper; Vomiting	FLU3~SANOFI PASTEUR~U1092AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231586	12/28/2004	OH	31.0	31		M	12/26/2003	Vomiting, Diarrhea, Ache, Nausea From initial information received on 10/Dec/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 31-year-old male patient received a dose of Fluzone SV 2003-2004 USP, lot number U1123AA, administered intra-muscularly in the deltoid and a PPD test ( lot number, manufacturer, route and site of adminstration not reported) on 08/Dec/2003 at noon.  The patient had also received a HEPATTIS A vaccine (lot number, manufacturer, route and site of administration not reported) within four weeks of receiving the products given on 08/Dec/2003.  On 09/Dec/2003 at 4:00 am, the patient developed nausea, vomiting, diarrhea and complained of body aches.  The patient's recovery status is currently unknown.									U	12/08/2003	12/09/2003	1		UNK	UNK	Aspirin, Lipitor	No illness.	No known allergies.  Denies medical conditions.		200303364	1						1	Diarrhoea; Nausea; Pain; Vomiting	FLU3~SANOFI PASTEUR~U1123AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231587	12/28/2004	NJ	30.0			F	12/26/2003	Pain in arm From initial information received on 11/Dec/2003 from the patient, who is a nurse, regarding an adverse event occurring in U. S. A., it was reported that the 30-year-old female received a first dose of Fluzone SV 2003-2004 USP, lot number not reported, administered in the deltoid on 08/Dec/2003.  Within several hours (also reported as onset date of 10/Dec/2003), the patient developed arm soreness, which was described as becoming very painful and tender with pain down the arm.  The patient reported that she took Advil for her symptoms.  Reportedly, the patient did not recover from thses events.  No other information was provided.									U					UNK	UNK					200303368	1						1	Myalgia; Pain	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231588	12/28/2004	GA	16.0	16		F	04/28/2004	From initial information received on 12/12/03 from the patient's father who is a physician regarding an adverse event occurring in the USA, it was reported that a 16 year old female patient received her first dose of FLUZONE, lot number U1076AA, administered IM in the left deltoid on 12/7/03. One day later, the patient developed joint swelling, difficulty ambulating, and a low grade fever. There was no nausea, vomiting, or diarrhea. No hematuria. At the time of vaccination, the patient also took contraceptives. Her pre-existing medical history includes allergies to horses, feathers, and cats. Otherwise, no medical conditions. The patient was treated with non-steroidal medications. Reportedly, the patient is feeling better, but is still sore.				Y					N	12/07/2003	12/08/2003	1		PVT	PVT	Contraceptives	NONE	Allergic to horses, feathers, cats. No medical conditions.		200303384	1						1	Difficulty in walking; Joint swelling; Pyrexia	FLU3~SANOFI PASTEUR~U1076AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231591	12/28/2004	TX	13.0	12		F	03/25/2004	From initial information received on 15Dec03 from a physician regarding an adverse event occurring, it was reported that a 12 year old female pt received a dose of Fluzone SV 2003-2004 USP, lot number U1127AA, administered IM in the right deltoid on 12Dec03. Within 24 hours, the pt developed a fever of 105 degrees F and flu like symptoms. The pt was given Tamiflu and Tylenol as treatment. Reportedly, she recovered from these events. The reporter of this case is the same reporter of case 2003-03399.				Y					Y	12/12/2003	12/13/2003	1		UNK	UNK		NONE	NONE		200303398	1						1	Influenza like illness; Pyrexia	FLU3~SANOFI PASTEUR~U1127AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231592	12/28/2004	TX	4.0			F	03/25/2004	From initial information received on 15Dec03 from a health care professional regarding and adverse event occurring, it was reported that a four year old female pt received a dose of Fluzone SV 2003-2004 USP, lot number U1127AA, administered IM in the right side of an unspecified site on 12Dec03. Within 24 hours the pt developed a fever of 103 Degrees F and flu-like symptoms, which resolved after being treated with Motrin. The pt recovered from these events. The reporter of this case is the same reporter of case 2003 03398.				Y					Y	12/12/2003	12/13/2003	1		UNK	UNK					200303399	1						1	Influenza like illness; Pyrexia	FLU3~SANOFI PASTEUR~U1127AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231593	12/28/2004	CT	0.97	0	1	M		From initial information received on 18Dec03 from a nurse regarding an adverse event occurring, it was reported that an 11 month old male pt received his first dose of Fluzone SV 2003-2004 USP, lot number U1111AA, administered IM in the left thigh on 17Dec03. The reporter received a voice mail from the pt's mother stating that on either 17Dec03 or 18Dec03, the pt developed rash on his head, shoulders and diaper area. The pt's recovery status was not reported. No other information was provided at this time.									U	12/17/2003	12/18/2003	1		PVT	UNK		NONE	NONE		200303594	1						1	Rash	FLU3~SANOFI PASTEUR~U1111AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231594	12/28/2004	CA	46.0			F	03/25/2004	From initial information received on 19Dec03 from manufacturer, regarding an adverse event occurring, it was reported by a physician that a 46 year old female pt received a dose of Fluzone SV 2003-2004 USP on an unspecified date. Sometime later, the pt developed lump at the injection site. The pt recovery status was not reported. From additional information received on 30Jan04, from another manufacturer (no reference number provided), it was reported by the pt's physician that the pt experienced a swollen arm one day after receiving the injection. The specific vaccination date was not provided. The physician reported that the pt called the office and stated that she had to take pain medication because of the swollen arm. The pt's recovery status was not provided. The adverse event coding for this case was updated to include arm swelling and injection site pain. Further information is not anticipated, this case is considered closed.									U					UNK	UNK			Osteoarthritis and depression		200303596	1						1	Injection site mass; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231595	12/28/2004	CO	46.0	46		M	01/07/2004	From initial information received on 22Dec03 from the pt who is a pharmacist, it was reported that the 46 year old male received a Fluzone SV 2003-2004 vaccination lot number U1078AA, administered SC in the left upper arm on 15Oct03. In the fall of 2003, the pt developed a low frequency tinnitus, which he described as being like the rumbling of a distant train. The pt had previously experienced the same symptoms in Nov of 2002 after receiving Fluzone SV 2002-2003 (lot not reported) SC in the left upper arm on 14Oct02. His symptoms had resolved by late summer 2003. He noticed the return of these symptoms following receipt of the influenza vaccine in 2003.The tinnitus is most noticeable in a quiet room or when camping in the wilderness. His symptoms became much worse, described as a throbbing, when pt developed a cold in November of 2003. The pt noted that the tinnitus has mostly resolved, however not completely.									N	10/15/2003				PUB	OTH			Pt received a dose of Fluzone SV 2002-2003 vaccine on 14Oct02. Sometime in Nov of 2002 the pt developed low frequency tinnitus, which he described as being like the rumbling of a distant train. The event resolved by late summer of 2003.	Tinnitus~Influenza (Seasonal) (Fluzone)~~45.00~In Patient	200303612	1						1	Pain; Pharyngitis; Rhinitis; Tinnitus; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U1078AA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231596	12/28/2004	PA				F	08/18/2004	From initial information received on 05Jan04 from the pt's uncle, who is also a physician, regarding an adverse event occurring, it was reported that a female pt (age and date of									Y	12/08/2003	12/11/2003	3	Strep culture was negative. The pt was not tested for flu or man metapneumovirus.	UNK	UNK					200400024	1						1	Cough; Hypokinesia; Pyrexia; Tonsillitis	FLU3~SANOFI PASTEUR~U1291AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231597	12/28/2004	PA				U	08/18/2004	From initial information received on 05Jan04 from the pt parent, who is also a physician, regarding an adverse event occurring, it was reported that the pt (gender, age and date of birth not reported) received a Fluzone SV 2003-2004 vaccination, lot number U1291AA, administered IM in the thigh on 08Dec03. Three days post vaccination, on 11Dec03, the pt developed a temp of 104 degrees F, tonsillitis, cough and decreased activity. According to the physician 'supportive care' was given. Reportedly the pt recovered from this experience. 10/Aug/2004: No additional information has been obtained from the reporter. Case is closed. The reporter of this case is the same reporter of case numbers 2004-00024, 2004-00027 and 2004-00028.									U	12/08/2003	12/11/2003	3	Strep throat culture was negative. Tests for influenza and human tapneumovirus not performed.	UNK	UNK					200400026	1						1	Cough; Hypokinesia; Pyrexia; Tonsillitis	FLU3~SANOFI PASTEUR~U1291AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231598	12/28/2004	PA				U	08/18/2004	From initial information received on 05Jan04 from the pt's parent, who is also a physician, regarding an adverse event occurring, it was reported that the pt (gender, age and date of birth not reported) received of Fluzone SV 2003-2004 vaccination, lot number U1291AA, administered IM in the thigh on 08Dec03. Three days post vaccination, on 11Dec/03, the pt developed a temp of 104 degrees F, tonsillitis, cough and loss of activity. According to the physician supportive care was given. The pt's recovery status was not reported. 10Aug04: No additional information has been obtained from the reporter. Case is closed. The reporter of this case is the same reporter of case number 2004-00024, 2004-00026 and 2004-00028.									U	12/08/2003	12/11/2003	3	Strep throat culture was negative. Tests for influenza and human tapneumovirus were not performed.	UNK	UNK					200400027	1						1	Cough; Hypokinesia; Pyrexia; Tonsillitis	FLU3~SANOFI PASTEUR~U1291AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231599	12/28/2004	PA				U	08/18/2004	From initial information received on 05Jan04 from the pt's parent, who is also a physician, regarding an adverse event occurring, it was reported that a pt (gender, age and date of birth not specified) received a Fluzone SV 2003-2004 vaccination, lot number U129AA, administered IM in the anterolateral thigh on 08Dec03. Three days post vaccination, on 11Dec03; the pt developed a 104 degree F temp, cough,loss of activity and tonsillitis.  According to the physician the pt received supportive care.  Reportedly the pt recovered from this experience. 10Aug04: No additional information has been obtained from the reporter. Case is closed. The reporter of this case is the same reporter of case number 2004-00024, 2004-00026 and 2004-00027.									Y	12/08/2003	12/11/2003	3	Strep throat culture was negative. Culture for influenza and human tapneumovirus not performed	UNK	UNK					200400028	1						1	Cough; Hypokinesia; Pyrexia; Tonsillitis	FLU3~SANOFI PASTEUR~U1291AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231600	12/28/2004	NY	8.0	8		M	02/09/2004	From initial information received on 16Jan04 from a physician regarding an adverse event occurring, it was reported that an eight year old male pt received Fluzone SV 2003-2004 USP, lot number U1148EA, administered IM on 09Jan04. Two hours post immunization, the pt developed funny movements of his hands and face, with some slurred speech. The pt was seen by a physician. These events still persist and he is being evaluated by a pediatric infectious disease specialist. From additional information received on 30Jan04 from, it was reported that a couple of hours after the vaccine was given the pt's lips swelled up. He did not have difficulty with breathing. Subsequent to that, he had an exacerbation of what was observed to be facial ticks. He also had some finger rolling bilaterally that seemed to be voluntary. He did not run a fever, he had no sensorium changes and there were no difficulties in school. The pt has had a past history of asthma and was on Advair daily including the day of vaccine. After the doctor examined him at the visit, which was routine third grade visit, he seemed congested so the doctor suggested that he be started on Albuterol inhalations. The mother gave him the first dose after they got home a few hours after the injection. He has been on that daily at least once or twice a day as well as Advair until one day ago. It is unclear how long pt has had these apparently nervous type ticks, however the family and teachers have noticed an increase in the ticks and finger rolling episodes. The pt does not seem to be particularly anxious or bothered by these things. He had not had any caffeine or chocolate during the week prior to examination by the pediatric infectious disease specialist on 16Jan04. At that time, the ticks had decreased and the hand rolling episodes had ceased. The pt's mother felt that he was back to usual self. At the visit it was noticed the pt's father also had some facial ticks and grimaces mainly involving the eyes and the lips. The family's interpretation is that with stopping the albuterol, whatever reaction was going is certainly much less. His physical examination was unremarkable with the exception of a slightly elevated blood pressure of 125 in the left arm and 127/68 in the right, possibly due to anxiety. Neurologically he had intermittent facial ticks, mainly closing one of his eyes and grimacing. He had no dysarthria or any overt neurological deficits. During the examination, he had one episodes of pill rolling, which the family has described as the movement of his fingers into the palms bilaterally. The physician felt that this seemed to be voluntary. The pt's motor function appeared fine and he was developmentally and psychosocially intact.  The physician's assessment is this was a possible allergic reaction to the influenza vaccine, as characterized by the swollen lip compound by antiasthma medications, particularly the albuterol, plus anxiety after the injection leading to an exacerbation of an underlying process of facial ticks with some unusual movements of the hands, but which have now subsided.				Y					N	01/09/2004	01/09/2004	0		PVT	PVT	Singulair, Albuterol, Advair	Additional information received on 30Jan04: On the day of vaccination, the pt seemed congested, so the doctor suggested that he be started on albuterol inhalations. The pt's mother gave him the first one after they got home a few hours after the injection.	The pt does have a history of reactive airway disease for which he takes Singulair and albuterol. Additional information received on 30Jan04: The pt has a past history of asthma and was on Advair daily, including the day of the vaccine.		200400173	1						1	Dysarthria; Dyskinesia; Face oedema; Tic	FLU3~SANOFI PASTEUR~U1148EA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231601	12/28/2004	IN	1.01	1	.0	F	06/29/2004	From initial information received on 01/20/04, from a health care professional regarding an adverse event occurring in the USA, it was reported that a one year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1145AA, administered in the left thigh as well as a dose of MMR, lot number 0512N, a dose of Varicella, lot number 0579N and a dose of Prevnar, lot number 491178, on 12/23/03. The routes and sites of administration were not reported. On week later, the patient developed eight small red dots located on her head, torso and genitals. Reportedly, the spots may have been hives. The patient's recovery status was not reported. From additional information received on 05/18/04 from the initial reporter, a correction was made to the patient's initials. It was reported that the patient had no illnesses at the time of vaccination and had no relevant past medical history. She required no treatment or evaluation following the adverse event and has had no reoccurrence of the symptoms.									Y	12/23/2003				PVT	UNK		NONE	NONE		200400286	1						1	Rash macular; Urticaria	FLU3~SANOFI PASTEUR~U1145AA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0512N~UNK~~~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|PNC~PFIZER\WYETH~491178~UNK~~~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0579N~UNK~~~VARICELLA (VARIVAX)~1	USA		Influenza
0231602	12/28/2004	NY	34.0	34		F	06/30/2004	From initial information received on 01/21/04 from a physician, regarding an adverse event occurring in the USA, it was reported that a 34 year old female patient received a Fluzone SV '200-'2004 USP vaccination, lot number not reported, administered intramuscularly on 12/10/03 at 10:00 AM. 12 hours post vaccination the patient developed a maculo-papular rash over her body lasting 12 days. The rash resolved after treatment with Medrol. The patient reportedly did recover from this event. From information received on 05/18/04 from a physician, it was reported that the information has been reviewed and no additional information is available. No further information is anticipated, this case is considered closed.				Y					Y	12/10/2003	12/10/2003	0		OTH	PVT		NONE	NONE		200400299	1						1	Rash maculo-papular	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231604	12/28/2004	NY				F		From initial information received on 03/12/04 from another manufacturer, initially reported by the patient, regarding an adverse event occurring in the USA, it was reported that a female patient (age not reported) received a dose of Fluzone SV '203-'2004 USP, lot number unknown, administered intramuscularly in an unspecified site on an unspecified date. Two to three weeks later, the patient developed a flu. The patient went to see a doctor and was told that 2-3 weeks was too soon for her to develop immunity. Reportedly, the patient recovered from this event.				Y					Y					UNK	UNK			Unknown		20040968	1						1	Drug ineffective; Influenza	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231605	12/28/2004	MD	10.0	10		M	04/06/2004	From initial information received on 03/30/04 from a medical clinic, regarding an adverse event occurring in the USA, it was reported that a 10 year old male patient received Daptacel, lot number C1527AA, administered in the right deltoid, and Fluzone SV '2003-'2004 USP, lot number U1129AA, administered in the left deltoid on 03/30/04. The dose of Daptacel was given in error. After the vaccinations, the patient felt ok, went to school, and passed out while waiting in the lunch line. Soreness was noted at the injection site of the Fluzone vaccination. The patient reportedly did recover from this event.									Y	03/30/2004	03/30/2004	0		MIL	OTH		NONE			200401355	1						1	Injection site pain; Loss of consciousness; Medication error	DTAP~SANOFI PASTEUR~C1527AA~UNK~~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1129AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231606	12/28/2004	OH	72.0	72		M	09/15/2004	From initial information received on 06/11/04 from an registered nurse regarding an adverse event occurring in the USA, it was reported that a 72 year old male patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1270AA, administered intramuscularly in the left deltoid on 10/14/03 at 11:00 AM. One week later, on 10/21/03, the patient developed a sore left arm at the site of injection. He was unable to lift the arm over his head and internal rotation of the arm was painful. Treatment included Vioxx 25mg daily, which reportedly helped initially, but the patient is never pain free. The patient has not recovered from these events. From additional information received on 09/07/04 from the initial reporter, it was reported that the number of previous Fluzone doses the patient received is not known. It was also stated that this report was  reviewed, no additional information at this time. 									Y	10/14/2003	10/21/2003	7	NONE	PVT	PVT	Coumadin, Enalapril, Tricor		The patient has a history of atrial fibrillation, coronary atherosclerosis, hypertension and hyperlipidemia. He had previously received several influenza vaccines, but it was not reported whether he had experienced adverse events following administration.		200402105	1						1	Hypokinesia; Injection site pain; Pain	FLU3~SANOFI PASTEUR~U1270AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231607	12/28/2004	PA	57.0	57		F	08/17/2004	From initial information received on 06/21/04 from the patient regarding an adverse event occurring in the USA, it was reported that the 57 year old female patient received a Fluzone SV '2003-'2004 vaccination, lot number U1269AA, administered intra muscularly in the left arm on 10/11/03. The patient stated that within 24 hours post vaccination, on 10/12/03, she developed muscle aches and pain in her arms, thighs and lower back. She was seen by an orthopedic physician, a chiropractor and a rheumatologist and was diagnosed with polymyalgia. Treatment included oral prednisone and cortisone injections into her left shoulder. The patient had not recovered from these events at the time of this report. From additional information received on 08/04/04 from the responsible physician, it was reported that there is no additional information at this time. It was not reported whether the patient recovered from these events.				Y					Y	10/11/2003	10/12/2003	1	Lyme disease test which was negative.	UNK	UNK			NONE		200402233	1						1	Back pain; Myalgia; Pain	FLU3~SANOFI PASTEUR~U1269AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231609	12/28/2004	GA	1.5			M	09/15/2004	From initial information received on 09/03/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that an 18 month old male patient received Fluzone SV '2003-'2004 USP pediatric dose vaccination and a Tripedia vaccination on 08/31/04. The lot numbers, route and site of administration are unknown. Reportedly the next day the patient developed a fever and was lethargic. The patient's recovery status is currently unknown.									U	08/31/2004	09/01/2004	1		UNK	UNK					200402955	1						1	Lethargy; Pyrexia	DTAP~SANOFI PASTEUR~~UNK~~~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231610	12/28/2004	OR	62.0	62		M	12/16/2003	From initial information received on 10/28/03 from the patient regarding an adverse event occurring in the USA, it was reported that the 62 year old male patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1090AA, administered in the left deltoid ( route of administration not reported) on 10/04/03. Within 24 hours, the patient developed fever, night sweats, chills, muscle aches and persisting weakness. The patient had lymphocytic leukemia at the time of vaccination. The patient's recovery status is unknown.				Y					U	10/04/2003	10/05/2003	1	Unspecified blood work	UNK	UNK		Lymphocytic Leukemia	The patient is allergic to erythromycin, which causes a rash.		200302794	1						1	Asthenia; Chills; Myalgia; Night sweats; Pyrexia	FLU3~SANOFI PASTEUR~U1090AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231612	12/28/2004	AZ	71.0	70		F	04/29/2004	From initial information received on 11/03/03 from a consumer, regarding an adverse event occurring in the USA, it was reported that the 70 year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1069AA, administered intramuscularly in the right deltoid on 10/22/03. Within one hour of vaccination, the patient noticed soreness underneath her arm. She reported that the pain was fairly close to the axillary area. The patient denied any redness, lumps, numbness or tingling. She stated that she had no limitations in mobility. The patient recovered from this event on an unspecified date.				Y					Y	10/22/2003	10/22/2003	0		PUB	UNK	Aciphex, Albuterol, Azmacort, Flonase, Valtrex, vitamins, Zestril	Denis	The patient has a history of asthma. She also has allergies to pollens, perfumes and household products. Reportedly, she receives an influenza vaccine yearly.		200302874	1						1	Pain	FLU3~SANOFI PASTEUR~U1069AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231613	12/28/2004	NC	55.0	54		F	01/13/2004	From initial information received on 11/19/03 from the patient regarding an adverse event occurring in the USA, it was reported that the 54 year old female patient received a dose of Fluzone SV '2003-2004 USP, lot number U1139AA, administered intramuscularly in her deltoid on 10/09/03. Three to four days after vaccination, the patient developed a severe sore throat, congestion, laryngitis and a temperature of 101 degrees Fahrenheit. She was seen by a physician and treated with antibiotics. The symptoms lasted two weeks and the patient recovered.				Y					Y	10/09/2003	10/12/2003	3		UNK	UNK	Bilagol, Tamoxifen, Vioxx	NONE	Environmental allergies.		200303196	1						1	Laryngitis; Nasal congestion; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U1139AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231614	12/28/2004	NY	74.0	74		M	12/02/2003	From initial information received on November 21, 2003 from a consumer regarding an adverse event occurring in USA, it was reported that a 74 year old male patient received Fluzone SV '2003-2004' USP, lot number U12699AA, administered intramuscularly in the left arm on October 13, 2003.  The next morning on October 14, 2003, the patient stated that he had developed hives on his torso, itching and his penis was full of fluid.  He was seen by a physician on an unspecified date.  The recovery status of the patient is unknown.				Y					U	10/13/2003	10/14/2003	1		UNK	UNK		NONE	NONE		200303210	1						1	Penis disorder; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1269AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231616	12/28/2004	PA	71.0	71		F	12/15/2003	From initial information received on 11/03/03 from the patient regarding and adverse event occurring in the USA, it was reported that the 71 year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number not reported, administered intramuscularly in the left deltoid and a dose of Pneumovax administered in the right are ( lot number and route of administration not reported), on 11/28/03 at approximately 9:00 AM. Two hours later, the patient developed itching throughout her body, but denied rash or hives. She was also afraid that she wasn't going to be able to take another breath and developed respiratory symptoms such as nasal congestion and watering eyes. The patient also felt weak and lousy. She still complains of symptoms and has not recovered. On 12/09/03 the lot number for the product was provided via e-mail. The lot number for Fluzone SV '2003-'2004 USP was U1133AA and for Pneumovax 0986N. No other information was provided at this time.									N	11/28/2003	11/28/2003	0		PVT	PVT	Colchicine, Lexapril	The patient reported that she had a cold on Monday of that week.	The patient has a history of seasonal allergies, as well as allergies to sulfa, tetanus and some antibiotics. She had previously received an influenza vaccine many years ago.		200303299	1						1	Asthenia; Dyspnoea; Lacrimation increased; Malaise; Nasal congestion; Pruritus	FLU3~SANOFI PASTEUR~U1133AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0986N~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0231617	12/28/2004	NE	32.0	31		F	03/25/2004	From initial information received on 12/05/2003 from the patient regarding an adverse event occurring in the U.S.A., it was reported that the 32 year old female patient received a dose of the FLUZONE SV '2003-'2004 USP, lot number U1087AA administered at 5:00 PM on 11/25/2003. Expiration date of the product is 01/30/2004. The route and site of administration were not reported. 21 hours later, the patient developed blisters at the site of injection. The patient's pre-existing medical conditions include allergies to codeine. Her concomitant medications include Eskalith, Lamictal, Tri-Norinyl and Wellbutrin. Reportedly, the patient recovered from this event.									Y	11/25/2003	11/26/2003	1		OTH	PVT	Eskalith, Lamictal, Tri-norinyl, Wellbutrin		Allergic to codeine		200303305	1						1	Injection site vesicles	FLU3~SANOFI PASTEUR~U1087AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231618	12/28/2004	AR	66.0			F	04/28/2004	From initial information received on 12/16/2003 from the patient regarding an adverse event occurring in the USA, it was reported that 66 year old female patient received a dose of FLUZONE SV '2002-'2003 USP, no other vaccine information provided, in November of 2002. Almost immediately after receiving the shot, the patient experienced intense itching and redness at the site of injection lasting two weeks. The patient also reported that the site was hot and there was some induration. Reportedly, the redness faded to a pink area and the discoloration continued for at least another week. The patient treated the symptoms with antihistamine tablets, Lanacane and Allegra. She has received the flu shot for many years (probably more than 40) and has no recollection of ever having a reaction. The patient also stated that she has eaten eggs many times before and since receiving the shot and she has had no adverse reaction. Reportedly, the patient recovered from these events.				Y					Y					PVT	UNK			The patient received the flu shot each year for many years (probably more than 40) and never had a raecion.		200303593	1						1	Feeling hot; Injection site erythema; Injection site induration; Skin discolouration	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231619	12/28/2004	IN	51.0	50		F	06/14/2004	From initial information received on 2/9/04 from the patient regarding an adverse event occurring in the USA, it was reported that a 50 year old female patient received her first dose of FLUZONE, lot number U1253AA, administered IM in the right arm on an unspecified day in November of 2003. That evening, the patient experienced soreness in her arm, which she described as a consistent ache that is sharp upon movement. Reportedly, the soreness persists. The patient also claimed to have a limited range of motion, but denied numbness or tingling. At the time of vaccination, the patient also took Premarin. Reportedly, the patient did not recover from this event.									N	11/01/2003	11/01/2003	0		UNK	UNK	Premarin	NONE	NONE		200400459	1						1	Hypokinesia; Myalgia; Pain	FLU3~SANOFI PASTEUR~U1253AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231621	12/28/2004	IA	9.0			F	06/14/2004	From initial information received on 2/24/04 from the patient's parent regarding an adverse event occurring in the USA, it was reported that a nine year old female patient received a Fluzone vaccination, lot number and route and site of administration unknown, on 12/3/03. Two days later, on 12/5/03, the patient experienced constant nausea, lightheadedness when standing, feeling of being cold all the time, ear pain, throat pain, and headaches. At the time of this report, the patient had not recovered from these events.									N	12/03/2003	12/05/2003	2	MRI; X-rays; Blood work; EKG; Upper GI.	PVT	UNK		NONE	Three weeks prior to this event, patient had strep throat.		200400751	1						1	Dizziness; Ear pain; Feeling cold; Headache; Nausea; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231622	12/28/2004	CA	23.0	23		M	06/18/2004	From initial information received on 3/3/04 from the patient, regarding an adverse event occurring in the USA, it was reported that a 23 year old male patient received FLUZONE, lot number U1143AA, administered on 11/4/03. By 11/11/03, the patient developed polyuria and extreme thirst. Not recognizing these symptoms, the patient slowly lost 20-25 pounds before seeing a physician on 2/3/04. The physician diagnosed him as a diabetic and on 2/12/04 it was verified he has Type I Diabetes. He now requires insulin shots and continual blood glucose monitoring. This was the first flu shot that the patient ever received. He had no concurrent vaccinations, and he was not taking any medications at the time. He reports that he was not ill at the time of vaccination, or anytime near 11/4/03. The patient reportedly has not recovered from this event.				Y					N	11/04/2003	11/11/2003	7		UNK	UNK		NONE	NONE		200400847	1						1	Diabetes mellitus; Polyuria; Thirst; Weight decreased	FLU3~SANOFI PASTEUR~U1143AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231623	12/28/2004	MI	2.0	2	.4	F	06/18/2004	From initial information received on 4/15/04 from the patient's mother regarding an adverse event occurring in the USA, it was reported that a three year old female patient received a dose of FLUZONE, lot number U0904CA, administered in the thigh on 10/16/02 in the AM. Later that day, the patient experienced swelling at the injection site, difficulty walking and a fever of 101 degrees F. Her past medical history is significant for autoimmune hemolytic anemia, juvenile arthritis and many food allergies, including an allergy to eggs. Her concomitant medications included steroids. Reportedly, the patient recovered from these events.									Y	10/16/2002	10/16/2002	0		UNK	UNK	Steroids	Juvenile arthritis	The patient has a history of autoimmune hemolytic anemia, juvenile arthritis, and many food allergies, including eggs.		200401632	1						1	Difficulty in walking; Injection site swelling; Pyrexia	FLU3~SANOFI PASTEUR~U0904CA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231624	12/28/2004	PA	12.0	12		F	11/14/2003	From initial information received on 11/12/03 from the patient's parent regarding an adverse event occurring in the USA, it was reported that a 12 year old female patient received a dose of FLUZONE, lot number not reported, administered on 11/10/03 at 6:00 PM (route and site of administration not reported). The next morning, the patient developed pain and swelling around the site of injection. The child missed school on 11/12/03. The patient's recovery status was not reported. No additional information was not received at this time.									U	11/10/2003	11/11/2003	1		OTH	UNK		NONE	NONE		200302965	1						1	Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231625	12/28/2004	TX	64.0			M	12/02/2003	Form initial information received on 18NOV2003 form the patient's wife regarding an adverse event occurring in the USA , it was reported that a 64 year old male patient received a dose of FLUZONE SV 2003-2004 USP and a dose of Pneumococcal Vaccine on 9OCT2003. The following day, the patient developed muscle aches and pains that have gotten progressively worse since the onset date. The patient was evaluated by six doctors including an internist, pulmonologist, gastroenterologist, neurologist, cardiologist, and rheumatologist. There is no confirmed diagnosis. The patient's blood work revealed elevated WBC and elevated CPK. An echocardiogram, muscle function testing, chest x ray, EMG and autoimmune tests were all normal. At the time of this report, the patient had nor recovered.				Y					N	10/09/2003	10/10/2003	1		UNK	UNK	Advair inhaler, Norvasc		The patient had a history of asthmatic bronchitis and hypertension. He previously received the 1999-2000 influenza vaccine.		200303193	1						1	Myalgia	FLU3~SANOFI PASTEUR~U1267AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~0287N~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0231626	12/28/2004	MD	46.0	46		F		This is a non-serious spontaneous case from a physician in the USA reporting a patient developed HIVES. The reporter causality between events and FluMist is not provided. This case is submitted according to the VAERS accelerated reporting agreement for FluMist. A 46 year old female developed hives under arms, abdominal pain, became restless and felt anxious after receiving FluMist. On 10DEC04, the patient received FluMist along with three allergy shots. She left the doctor's office and after five minutes became anxious and drove back to the physician's office. Her vital signs were within normal limits but she was restless with abdominal pain. She also had hives under her arms, which were not diffuse, within one hour of Flumist vaccination. There were no respiratory symptoms or swelling. The patient took benadryl before going to the ER. She as treated at the ER with solumedrol and IV fluids after which she was released. The patient has recovered from all events. The patient has a history of allergies but not to eggs and receives allergy desensitization shots in the reporting physician's office. The reporting physician feels that in the future, vaccine and allergy shots should be separated. The reporter determined the events to be unrelated to FluMist due to administation of concurrent allergy shots with the FluMist vaccination. 09Feb05 Additional information received: Pt's date of birth, confirmatin that the time of vaccine admin and onset of events were not recorded.									Y	12/10/2004	12/10/2004	0	None indicated.	PVT	OTH	Concomitant drug(s) not reported.		Previous allergy shots due to allergies		MEDI0002562	1						1	Abdominal pain; Anxiety; Restlessness; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500338AP~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0231627	12/28/2004	CA	4.0	4		F	12/21/2004	Patient brought to ED on 12/19/04 in full arrest and could not be resuscitated. That ED notified our hospital that patient had died. Our hospital does not have further details at this time.	Y	12/19/2004							N	12/16/2004	12/19/2004	3		PVT	UNK	Albuterol; Pulmicort; Reglan; Zantac	NONE	Tay Sachs disease; Mental Retardation; GE Reflux; Lung Disease			1						1	Cardiac arrest; Respiratory arrest	FLU3~SANOFI PASTEUR~U1501AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0231628	12/28/2004	CA	85.0	84		M	12/01/2004	S/P Flu vaccine 3 days earlier. Found expired in morning.	Y	10/18/2004							N	10/15/2004	10/18/2004	3	NONE	PVT	UNK	Caromra, ASA, Pedol, Pravadoe, Parcept, Flexout, Lisinopril, Lasix, Tablol	CAD; DSD; HTN; DMI; CHF	CAD; DSD; HTN; DMI; CHF			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U1394BA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0231629	12/28/2004	MI	82.0	81		F		Symptoms of stroke (facial paralysis and slurred speech) developed next day. Admitted to hospital; symptoms cleared in 24 hours. Diagnosis: TIA. Medical records state 7th nerve palsy. msv					Y	2			Y	11/05/2004	11/06/2004	1	CT Scan: no stroke. Discharge summary states abnormal lab tests. msv	PVT	UNK		NONE	NONE Discharge summary states hypertension, hyperlipedemia, hypothyroid, meningioma. msv Medical records states colitis, unstable gait, hearing loss. msv			1						1	Cerebrovascular accident; Dysarthria; Facial palsy; Laboratory test abnormal; Transient ischaemic attack	FLU3~SANOFI PASTEUR~U1421AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0231630	12/28/2004	MN	31.0	30		F	12/20/2004	Miscarriage at six weeks gestation one week after flu vaccination.					Y	1			Y	10/28/2004	11/02/2004	5	U/S confirmed fetal demise.	PVT	PVT	Prenatal vitamins.	Pregnancy	NONE			1						1	Abortion spontaneous	FLU3~SANOFI PASTEUR~U1453FA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0231631	12/28/2004	MD	1.33			F	12/28/2004	Drastic personality change overnight. Attention span decreased, hyperactive. Will visit the doctor today to start testing for ADD.				Y					N					PVT	PVT	NONE	NONE	Allergic to amoxicillin	fever~Influenza (Seasonal) (no brand name)~0~1.25~In Patient		1						1	Personality disorder; Psychomotor hyperactivity	FLU3~SANOFI PASTEUR~U1417AA~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231632	12/28/2004	CA	44.0			M	12/20/2004	Pt suffers from acute sinusitis two to three times a year, usually occurring after the start of a viral infection. Where pt lives has low humidity 20-30% RH most of the year. And air pollution especially particulate. He works in an office environment where the humidity is usually slightly lower than outside air, it can be raining outside, but humidity inside would be about 35 to 40% RH inside. Office RH not uncommon below 30%, even down to 18% at times. Pt sleeps at home in humidity above 35% and increases humidity to about 60% when nasal irritation is detected. On 27Nov04 at Noon I received FluMist influenza virus vaccine lives, IN. At about 12 hours later I started to get a runny nose and slightly sore throat. Each of the following days it got worse. I stayed home from work for December 1st to December 6th and rested. Felt better Dec 7 but still had a slight sore throat and post nasal drip of thick white phlegm. During the whole time no significant cough or breathing or chest problems. On December 14th started to get worse again on Dec 16th say my Ear Nose and Throat Doctor and he prescribed Ketek Pak, the 400mg tablet taken two at a time for five days; started taking the Ketek on Dec 16th at 11:00AM. Took the next two days off from work and on Dec 18th at 1:00PM started to get worse. By Dec 18th at 7:00PM was bad enough sinus pain and pressure; facial pressure; eye orb pressure; fever of 99.9F called the doctor on call and got a prescription for Augmentin for a 15 day period. Started feeling better on Dec 19th at about 10:00AM when yellow phlegm started to come out left nostril. Still recovering as of Dec 20th 3:30PM but feeling much better with thick sinus mucus and left eye pain when looking to extreme left, right, up and down.									U	11/27/2004	11/27/2004	0	NONE	UNK	UNK			Allergies: hayfever, periodic acute sinusitis. Reflux treated with Nexium. Gallstones.			1						1	Eye pain; Pharyngolaryngeal pain; Rhinitis; Rhinorrhoea; Sinusitis	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0231633	12/28/2004		85.0			M	10/29/2004	Rash									U		10/08/2004			UNK	UNK						1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0231634	12/28/2004	WA	0.58	0	.6	M	12/06/2004	Maculopapular rash left thigh, onset within hours of immunizations.									Y	12/01/2004	12/03/2004	2	NONE	PVT	PUB	NONE	Eczema	Eczema			1						1	Injection site reaction; Rash maculo-papular	DTAP~SANOFI PASTEUR~C1696AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1483AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE206AA~3~IM~RL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~X0799~3~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~A83578A~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0231635	12/28/2004	VA	28.0	27		M	12/01/2004	3 raised papules and pustules on chest and shoulders				Y					Y	10/16/2004	10/27/2004	11		MIL	MIL		NONE	NONE			1						1	Rash papular; Rash pustular	ANTH~EMERGENT BIOSOLUTIONS~FAV083~1~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1501AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231636	12/28/2004	MT	55.0	54		F	12/16/2004	Local reaction in left deltoid 2 days after vaccination 2 in induration with redness, heat, feverish all over. 2-3 weeks later, intense heat on  shoulder, elbow,wrist joints, decreases ROM, pain.				Y					U	10/28/2004	10/30/2004	2	ANA screen- neg. RA Ther- neg	OTH	UNK	NONE	NONE	NONE			1						1	Feeling hot; Hypokinesia; Injection site erythema; Injection site mass; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1479AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231637	12/28/2004	MA	6.0	6		F	12/23/2004	1 day after Flumist, headache, pale, warm to touch, 2nd day rash on forehead and right side of forehead, seen in office (12/10/04) at pediatricians. Observe.				Y					Y	12/06/2004	12/07/2004	1		PVT	PVT		NONE	NONE			1						1	Feeling hot; Headache; Pallor; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500352~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0231638	12/28/2004	ME	14.0	13		M	12/22/2004	12 hrs after vaccine developed red, swollen area 10cm in diameter. Indurated tender. Fever, chills.				Y					U	12/20/2004	12/21/2004	1		PVT	PUB		NONE	Asthma			1						1	Chills; Injection site erythema; Injection site mass; Injection site oedema; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~U1528AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0685N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0231639	12/28/2004	CA	83.0	83		F	12/22/2004	Severe dizziness, lasted two days no treatment									Y	12/11/2004	12/12/2004	1		PUB	OTH	Actonel					1						1	Dizziness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0231640	12/28/2004	MA	12.0	11		F	12/23/2004	Fever 101 stiff neck, cold like symptoms, 10 days after Flumist. No treatment 48hrs.									Y	12/02/2004	12/12/2004	10		PVT	PVT	NONE	NONE	NONE			1						1	Musculoskeletal stiffness; Pharyngitis; Pyrexia; Rhinitis	FLUN3~MEDIMMUNE VACCINES, INC.~50035P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0231641	12/28/2004	OH		1	.6	F	12/13/2004	Pt was given 0.25ml of flu vaccine on 12/06/04. Reaction began 12/7/04. Red blotches from waist down on 12/8/04. Progressed to entire body by 12/9/04. Benadryl was started on 12/8/04. On 12/9/04, child went to med ctr and started Atarax.				Y					Y	12/06/2004	12/07/2004	1		PUB	PUB		NONE	NONE	sl rash/papular rash. PMD thought not true flu vac reaction~Influenza (Seasonal) (no brand name)~1~1.00~In Patient		1						1	Erythema; Rash macular	FLU3~SANOFI PASTEUR~U1459AA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231642	12/28/2004	VA	44.0	43		M	12/22/2004	Bells Palsy occurred 1 days after receiving flu vax and hep B vax				Y					U	12/20/2004	12/21/2004	1	Lyme test, CBC Pending	PVT	PUB	HCT 12.5 qa	NONE	HTN		VA04047	1						1	Facial palsy	FLU3~SANOFI PASTEUR~U1382FA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0433P~3~~LA~HEP B (RECOMBIVAX HB)~1	USA	Emergency room visit	Influenza
0231661	12/28/2004	VA	66.0	65		M	12/28/2004	Client fell asleep within few minutes after the shot (unwitnessed by staff); when woke up approximately 40 minutes after the shot he was confused, disoriented, didn't remember having received the flu shot.  He was aware something was wrong - kept saying this is weird and why am I here?.  No obvious neurological deficits other than mild confusion and short term memory loss.   BP 168/100 initially, 190/110 after 15 minutes.  Referred to ER but client left on own with family to go to another ER where he was told he had a reaction to his flu shot.  Referred to a doctor the next day, who felt he probably had a TIA.  Had brain CAT scan on 12/21/04 (results unknown at this time), scheduled to have an unltrasound on 1/17/05.  Per phone call follow-up on 12/21, client states he felt fine the next morning when he woke up, but was aware of episode from the previous evening.  He and his family state he has never had any similar episodes in the past.				Y					U	12/15/2004	12/15/2004	0	CAT scan of brain 12/21/04 - results unknown Scheduled for ultrasound on 1/17/05	UNK	UNK	Unknown	None	Hypertension			1						1	Amnesia; Blood pressure increased; Confusional state; Disorientation; Somnolence; Transient ischaemic attack; Vaccination complication	FLU3~SANOFI PASTEUR~U1382EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231662	12/28/2004	MD	81.0	80		M	12/28/2004	R arm pain at injection site beginning day after injection.  Pain when raising arm over head or crossing arm over body.  No discomfort when using arm at torso height.									U	12/14/2004	12/15/2004	1		UNK	UNK		denied	denied			1						1	Injection site pain; Pain	FLU3~SANOFI PASTEUR~U1527AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231664	12/28/2004	MD	79.0	78		F	12/28/2004	Patient hospitalized with diagnosis on Legionellosis on 12/21/2004. Onset of symptoms 12/16/2004 - patient and family attributed illness to vaccination.	Y	12/23/2004							N	12/15/2004	12/23/2004	8	Urinary antigen positive for Legionella	UNK	UNK		None reported				1						1	Bacterial infection; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U1527AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0231669	12/28/2004	AZ	41.0	41		F	11/09/2004	Within 1 hr of receiving pneumococcal vaccine developed severe pain, swelling, redness and warmth that has persisted over 24 hours, right deltoid.									U	11/08/2004	11/08/2004	0	UTI	OTH	OTH		UTI, DM 2	NONE			1						1	Feeling hot; Injection site erythema; Injection site oedema; Injection site pain; Urinary tract infection	FLU3~SANOFI PASTEUR~U1453DA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0287P~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0231670	12/28/2004	MN	50.0	50		F	12/10/2004	Pt had swollen arm from elbow to shoulder and warm to touch about 8 hrs after injections. 3 shots in right arm. Td, Flu, Pneumovax, lasted a few days and got better. Iced and used her pain meds. In from arm pit down to elbow from Pneumovax, site swollen									Y	12/01/2004	12/02/2004	1		PVT	PVT	Botox inj 100 U, in left deltoid previous at another facility					1						1	Feeling hot; Injection site pain; Injection site reaction; Oedema peripheral	FLU3~SANOFI PASTEUR~U1579AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0863N~UNK~SC~~PNEUMO (PNEUMOVAX)~1|TD~AVENTIS PASTEUR~U1354AA~UNK~~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0231180	12/29/2004	CA	10.0	9		M	12/28/2004	This is a serious post marketed study case from a physician in the USA of who reports a patient experienced TONGUE DYSTONIA after receiving FluMist. The reporter determined the events to be possibly related to FluMist vaccination. On 10/29/04, a 9 year old male received FluMist intranasally and experienced dystonic tongue posturing as well as becoming glazed over on 11/01/04. The mother reported the patient was talking with his tongue thrust up behind his front teeth and was glazed over and just not himself. She also reports her son had some word finding problems for several weeks. Neurological findings stated the patient had a previous episode of prolonged dystonic tongue posturing in 1999 after a febrile seizure. The neurologist stated that this second episode is temporally related to a influenza nasal vaccine. Neurological findings further stated whether the vaccine was causative is not ascertainable, but should be reported as a possible adverse effect. The physician stated the duration of the event makes an epileptiform activity unlikely. The neurologist further stated that the fact the tongue dystonia involved talking activity of the the tongue and not eating activities was difficult to rationalize. An MRI will be performed looking for focal structure abnormality due to the recurrent nature of the events. No follow up is needed unless the event recurs. The patient recovered five weeks after the events began. The reporter determined the events to be possibly related to FluMist.									Y	10/29/2004	11/01/2004	3	NONE	OTH	PVT	NONE		1/16/99: History of febrile seizure resulting in episode of dystonic tongue posturing. 9/96: Right wrist fracture.		MEDI0002615	1						2	Abnormal behaviour; Dystonia; Speech disorder; Tongue disorder; Condition aggravated; Dyskinesia; Dystonia; Mental impairment	FLUN3~MEDIMMUNE VACCINES, INC.~500335P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500335P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0231676	12/29/2004	KY	27.0	27		F	12/17/2004	This is a serious spontaneous case from a nurse in the USA of involving CHICKEN POX. The reporter causality is not provided to FluMist. Case reference MEDI0002596 is a spontaneous case report sent by a nurse which refers to a female aged 27 years. The patient received FluMist on 12/9/04. The patient developed a red spot type blister rash that appeared on her face, chest and back on 12/11/04. The patient had complaints of lung pain and uncomfortable lesions in her mouth. The patient was examined by a physician on 12/13/04 and the physician suggested the blister rash could have been chicken pox. On 12/15/04, the patient required hospitalization for chicken pox. The patient's varicella IgM test was negative. The patient's chest x-ray revealed nothing active. The wound cultures from the patient's chest and head and urine culture had no growth. The wound culture from her face had light growth. The patient's sputum had normal upper respiratory flora. The patient was discharged on 12/16/04. No further information is available.					Y	1			Y	12/09/2004	12/11/2004	2	Chest x-ray negative; IgG: Varicella negative; Sputum culture: normal upper respiratory flora; Urine culture: no growth; Wound culture (chest): no growth; Wound culture (face): light growth; Wound culture (head): no growth.	PVT	OTH	NONE		NONE		MEDI0002596	1						1	Blister; Erythema; Laboratory test abnormal; Mouth ulceration; Rash; Viral infection	FLUN3~MEDIMMUNE VACCINES, INC.~500352P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0231677	12/29/2004	TX	15.0	15		M	12/10/2004	This is a serious post-marketed study case from a physician in the USA who reports a patient experienced PERIORBITAL SWELLING after receiving FluMist. The reporter determined the events to be related to FluMist vaccination. On 12/05/04, a 15 year old male received FluMist intra-nasally and experienced nausea, dizziness, and periorbital edema within 20 minutes of vaccination, all considered medically important (OMIC). He was treated with 37.5mg Benadryl and monitored at the vaccination site. His vital signs remained stable and he never developed hypotension, respiratory distress, shortness of breath, upper airway obstruction, or wheeze. He was observed for 45 minutes until all symptoms resolved. Follow up the following day was unremarkable. The investigator determined the events to be related to FluMist vaccination.									Y	12/05/2004	12/05/2004	0	NONE	OTH	OTH	Nutropin		NONE		MEDI0002589	1						1	Dizziness; Nausea; Periorbital oedema	FLUN3~MEDIMMUNE VACCINES, INC.~500335P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0231744	12/29/2004	KS	38.0	37		F	11/15/2004	Onset 11/9/04 of left leg numbness/weakness. As of 11/10/04, right and left leg numb and weak. Eventual sensory level negative. Hospitalized and diagnosed with transverse myelitis. Seen by neurologist. Receiving high dose medications. Slightly better; not recovered yet. Discharge Summary received on 1/12/2005 states edema, anxiety, and sleeplessness. Medical Record received on 1/12/2005 states dizziness. 60 Day Follow Up: continues to have lower extremity weakness and neuropathic pain.				Y	Y	7			N	11/04/2004	11/09/2004	5	Negative MRI L-spine	PVT	PVT	Lipitor; Lexapro; Estrace	NONE	No allergies; History of elevated lipids, depression, and vertigo. Medical Record received on 1/12/2005 states migraine and palpitations.		KS200434	1						1	Anxiety; Dizziness; Hypoaesthesia; Insomnia; Muscular weakness; Myelitis transverse; Neuropathy; Oedema; Pain	FLU3~SANOFI PASTEUR~U1378AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0231746	12/29/2004	KS	71.0	70		F	11/18/2004	Rash noted after shower, and sore shoulder.									Y	11/15/2004	11/17/2004	2		OTH	PVT		NONE	NONE		KS200435	1						1	Arthralgia; Rash	FLU3~SANOFI PASTEUR~U1438AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0740N~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0231748	12/29/2004	KS	1.27	1	.3	M	11/11/2004	Fever began 11/09/04. Macular rash began 11/11/04.				Y					U	11/01/2004	11/09/2004	8	NONE	PVT	PUB		No	NONE		KS200432	1						1	Pyrexia; Rash macular	DTAP~SANOFI PASTEUR~U1258DA~4~IM~~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1560AB~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0451P~4~IM~~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~1185N~1~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~495-203~4~IM~~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0711N~1~SC~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0231753	12/29/2004	TX	47.0	46		F	12/29/2004	Complained of diffuse pain radiating from site of injection (right deltoid) down to wrist. Pain began a day or two after injection and continues to present time. Has been using ibuprofen for pain. Has not been seen by physician at this time.									N	11/01/2004	11/02/2004	1	None completed at this time	UNK	UNK	None	None	N/A			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U1438AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231754	12/29/2004	NH	13.0	13		M	12/29/2004	About 5 minutes after injection, while standing he suddenly felt dizzy, fainted, slumped to floor, for next 45 minutes continued to feel poorly, mildly hypotensive, also with neck pain and shoulder pain after fall. then vomitted, continued to be dizzy.  So sent to ER for further evaluation.				Y					U	12/29/2004	12/29/2004	0		UNK	UNK		cough, recovering from strept throat	none			1						1	Dizziness; Hypotension; Injury; Malaise; Neck pain; Shoulder pain; Syncope; Vomiting	FLU3~SANOFI PASTEUR~U1438AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231755	12/30/2004	CA	37.0	37		M	11/30/2004	Client complained of heartburn like sensation and was sent to medical center. They diagnosed him with allergic reaction  to flu vaccine. This was on 11/18. Client became unresponsive on Sunday 11/21 and had begun to show red bumps on face. He was alert in the morning, ate breakfast then fell ill. He was transferred to another hospital when he fell into a coma and passed away 11/23/04. Discharge Summary revealed patient had confusion and respiratory failure.	Y	11/23/2004							N	11/17/2004	11/18/2004	1		OTH	PUB					CA040096	1						1	Apnoea; Coma; Confusional state; Dyspepsia; Encephalopathy; Hypersensitivity; Malaise; Rash; Viral infection	FLU3~SANOFI PASTEUR~U1519AB~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0231756	12/30/2004	CA	44.0	44		M	11/20/2004	Client came down with chicken pox origin unk. Client is responding well to treatment. Illness has taken its course and client is healing.				Y					Y	11/17/2004	11/20/2004	3		OTH	PUB					CA040095	1						1	Viral infection	FLU3~SANOFI PASTEUR~U1519AB~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231757	12/30/2004	CA	11.0	10		M	11/04/2004	Received influenza vaccine 11/1/04; 11/2/04 experienced weakness, numbness and tingling of both legs; also turned blue. Seen in ER that day; as vaccines given. Mom gave Motrin; symptoms resolved by 11/4/04. Examined 11/5/04 neurologic exam normal.				Y					Y	11/01/2004	11/02/2004	1	Pending at hospital Information from ER summary states elevated WBCs and other abnorma lab results. msv	PUB	PUB	Pulmicort, Singulair, Albuterol, Nasonex	NONE	Malaise, persistent asthma		CA040098	1						1	Asthenia; Cyanosis; Hypoaesthesia; Laboratory test abnormal; Leukocytosis; Paraesthesia	FLU3~SANOFI PASTEUR~U1440AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231774	12/30/2004	CA	4.0	4		F	04/14/2004	Swelling and redness of left upper arm with fever the night of the injection.									U	04/12/2004	04/12/2004	0	N/A	PUB	PUB	None		None		ca040094	1						1	Erythema; Pyrexia; Swelling	DTAP~SMITHKLINE BEECHAM~2610A2~5~~LA~DTAP (INFANRIX)~1|FLU3~PARKDALE PHARMACEUTICALS~4525G261~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|IPV~PASTEUR MERIEUX CONNAUGHT~N08692~4~~LA~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0611N~2~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0231780	12/30/2004	MO	1.87	1	.9	M	12/20/2004	Had 5-6 minute seizure - due to 100.3 fever accourding to Emergency Room report - eyes rolled back and head flailing slightly, rest of body limp - mom called EMS and was transported, stayed in ER several hours. Information from medical records states irritable, urinary trct infection, post ictal state. msv				Y					Y	12/08/2004	12/18/2004	10	Blood tests done at Emergency Room Informatio received from Medical records indicates abnormal lab tests. msv	UNK	UNK	None	None	Allergic to Penicillin		MO200455	1						1	Convulsion; Dyskinesia; Eye movement disorder; Hypotonia; Laboratory test abnormal; Nervousness; Postictal state; Pyrexia; Urinary tract infection	DTAP~SANOFI PASTEUR~U1316AA~4~IM~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1473AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE314AA~3~IM~RA~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~X0799~3~SC~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1186N~UNK~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A57560M~4~IM~LA~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0654P~UNK~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0231782	12/30/2004	MO	23.0	23		M	12/30/2004	Maculopapular/vesicular rash of upper extremities and lower extremities; some lesions with erythematous bases and scaling and excoriation (most likely due to scratching). No fever, nausea, vomiting, or lymphadenopathy.  Suspect erythema multiforme minor.									U	12/07/2004	12/25/2004	18	Cutaneous biopsy obtained today. Sample will be sent to hospital for testing.	MIL	MIL	NONE	NONE	NONE			1						1	Erythema; Erythema multiforme; Rash maculo-papular; Rash vesicular; Skin exfoliation; Skin ulcer	FLU3~SANOFI PASTEUR~U1515AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABA016AB~1~IM~RA~HEP A + HEP B (TWINRIX)~1|SMALL~PFIZER\WYETH~4020072~1~~LA~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~X0521~2~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0231793	12/30/2004	NY	48.0	48		F	12/27/2004	Pt received FluMist on 11/23/2004. She reports that on Friday 11/26, she developed profound myalgia, fever, chills, sore throat. On 11/27 she sought trmt from her personal physician.				Y					Y	11/23/2004	11/26/2004	3	NONE	PUB	OTH	NONE	NONE	NONE			1						1	Chills; Myalgia; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500340P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0231794	12/30/2004	CA	29.0	29		F	12/24/2004	12/22/2004 pt states she feels warm, c/o palpitations and chest heaviness, beginning approximately 2-3 hours after flu vaccination. Apical rate 90, irreg. Resp's=18 unlabored. Color pink, warm, dry, afebrile. Enc f/u with Urgent Care or personal MD; or emergency Dept. Declined follow up with MD. 12/24/04 follow up with pt, no further symptoms, resolved.									Y	12/22/2004	12/22/2004	0	NONE	PVT	PVT	PPD	NONE	Allergic to aspirin			1						1	Arrhythmia; Chest pain; Feeling hot; Palpitations	FLU3~SANOFI PASTEUR~U1569AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231795	12/30/2004	MA		0	.8	F	12/27/2004	Generalized intermittent hives 4 days after receiving DTaP 2, IPV  2, PCV7 2, HIB 2, Flu Vaccine 1.									Y	12/16/2004	12/19/2004	3	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Urticaria	DTAP~SANOFI PASTEUR~U1314AA~2~~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1454AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE232AA~2~~LL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~X1189~2~~RL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~495719~2~~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0231785	12/31/2004	CA	18.0	18		F	12/31/2004	Abrupt diarrhea and cramping occuring one week after vaccination. Lasted 1-1/2 days. Self-care, took ibuprofin for pain. Sinus trouble for one week, following two days after vaccination.									Y	12/08/2004	12/14/2004	6		UNK	UNK	Prozac, occasional ibuprofen.	Possible onset of cold.				1						1	Diarrhoea; Muscle spasms; Pain	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0231786	01/01/2005	MA	63.0	63		F	01/01/2005	HOARSENESS, DIZZINESS.									U	12/31/2004	01/01/2005	1		UNK	UNK						1						1	Dizziness; Dysphonia; Dizziness; Dysphonia	FLU3~SANOFI PASTEUR~U1516AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1516AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0231787	01/02/2005	MD	30.0	30		F	01/02/2005	fever - 101 degrees for 2 days severe coughing weakness chills head congestion									N	12/30/2004	12/31/2004	1		UNK	UNK		none	none			1						1	Asthenia; Chills; Cough; Nasal congestion; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~1~PO~MO~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0231788	01/02/2005	VA	18.0	18		F	01/02/2005	Sunburn-like rash on upper arms appeared approx. 32 hours after vaccination.  Nasal congestion, runny nose, fatigue,  sick feeling starting approx. 45 hours after vaccination.  Benadryl 50mg taken for rash; rash disappeared within 10 hours.  Chlortrimeton 4mg taken for cold symptoms.  Cold-like symptoms lasted 3-1/2 days.									Y	12/27/2004	12/28/2004	1		UNK	UNK		None	None			1						1	Fatigue; Malaise; Nasal congestion; Pharyngitis; Rash; Rhinitis; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~580351P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0231790	01/02/2005	CA	16.0	15		M	01/02/2005	Immediately saw sparkles, became dizzy, had poor color and was pale.  Became very hot then cooled about 5 minutes later.  Left clinic. Went to school.  Developed hives.  Developed flu like symptoms.  Fever, leg cramps.  Hospitalized in intensive care with Viral Sepsis. Discharge Summary received states vomiting, chills, rash, hypotension, tachycardia, and viral exanthema.  Follow up 03/07/05:Information on manufacturer, will have to be obtain from another facility. The patient has recovered from the adverse event(s) but states It was hell.			Y	Y	Y	3			Y	10/13/2004	10/13/2004	0	Medical Records received on 1/20/2005 states WBC increased.	UNK	UNK	None	No	CP, allergies to Doxycycline, Minocycline, Erythromycin.  Discharge Summary received on states pt has cerebral palsy.			1						1	Chills; Dizziness; Feeling hot; Hypotension; Influenza like illness; Leukocytosis; Muscle spasms; Pallor; Pyrexia; Rash; Sepsis; Tachycardia; Urticaria; Viral infection; Vitreous floaters; Vomiting	FLU3~SANOFI PASTEUR~U1378AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0231830	01/03/2005	TN	90.0	89		F	12/22/2004	From initial information received on 12/21/04 from the patient's niece regarding an adverse event occurring in the USA, it was reported that an 89 year old female patient received a dose of FLUZONE at 11:00 AM on 10/11/2004. The lot number, site and route of administration were not provided. Eight hours later, on 10/11/04 at 7:00 PM, the patient complained of dizziness and her hands were shaking. She was seen in an emergency room, was diagnosed with kidney failure and was admitted to the hospital on 10/11/04. The patient was seen by renal specialists, critical care physicians, neurologists and infectious disease. The patient was hospitalized until she died on 12/13/04. No autopsy was performed. Medical Records received on 1/07/2005 states pneumonia and respiratory failure.	Y	12/13/2004		Y	Y	63			N	10/11/2004	10/11/2004	0	EKG; CT scan of the head; X-ray of the head; Chest X-ray, an EEG and blood work were performed, however the results were not provided. An autopsy was not performed.	PVT	UNK	Lipitor; Pindol; Synthyroid; Koracon; Prednisone; Hydrochlorazide		The patient's past medical history is significant for hypertension, high cholesterol and arthritis. She did not have any illnesses at the time of vaccination. Her vaccination history includes 10 doses of influenza vaccine on unspecified dates. At the time of vaccination, the patient was also taking the following medications: Lipitor, Pindol, Hydrochlorazide; Synthyroid, Kloracon, and Prednisone.		200404004	1						1	Dizziness; Pneumonia; Renal failure; Respiratory failure; Tremor	FLU3~SANOFI PASTEUR~~7+~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0231838	01/03/2005	CA	1.12	1	.1	F	12/27/2004	Patient had febrile seizure within 12 hours of administering vaccines (MMR, Varivax, Influenza). Temp 104.7 in ER at hospital. Admitted for observation for 24 hours. Follow up 02/16/05: Possible shivers/chills, what sounds like a generalized tonic clonic seizure. The event taks place 9.5 hours immunization. Has a twin who who did not have adverse event. Information received from discharge summary states chills.					Y	1			Y	12/21/2004	12/21/2004	0	Information from discharge summary states leukocytosis. msv	PVT	PVT		NONE	NONE			1						1	Chills; Febrile convulsion; Leukocytosis; Pyrexia	FLU3~SANOFI PASTEUR~U1467AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0345P~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0645P~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0231839	01/03/2005	LA	59.0	58		F	12/17/2004	02/15/2004 Received flu and PPV 23 AM 101.4 temp 8:30 or 9:00PM. Ice packs applied Wed night. All day Thurs. Took Ibuprofen yesterday and this AM (I called private MD nurse at office to call pt at home today). Referred to MD if not improved.									U	12/15/2004	12/15/2004	0		PUB	UNK	Vit D, Celebrex, Effexor, Glucosamine, Zocor	NONE	PCN, cetyl alcohol, Arthritis, mastectomy (L) breast.		LA041215	1						1	Pyrexia	FLU3~SANOFI PASTEUR~U1531AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0605P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0231840	01/03/2005	LA	64.0	64		F	12/17/2004	Noticed right of 12/15/04 left arm was red. More swelling noted 12/16/04. See pack applied off and on. Redness moved further down arm, will apply ice packs and take Benadryl, will go to MD on 12/18/04 if unimproved.									U	12/15/2004	12/15/2004	0		PUB	UNK	Swish and swallow	NONE	No Allergies, Arthritis, Fibromyalgic		LA041214	1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1531AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0605P~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TTOX~SANOFI PASTEUR~U1185AA~1~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0231841	01/03/2005	CA	46.0	45		F	11/06/2004	Starting on 10/25/04 the following symptoms occurred upon waking in the morning: extreme pain and burning in both hands, especially at the finger tips, swollen hands and very swollen middle finger joint on right hand. Both hands were stiff, tingling, hard to make a fist/clench, and had a grainy sensation. Both hands were weaker and more uncoordinated than before the vaccine. I experienced colder hands now. My feet especially the toes were tingling, aching and very painful. My knee joints were also aching. About one week after the vaccine, I have had intestinal problems. My bowel movements have been looser and there is a bad smell to them, other than the usual. I feel achy in the intestines and more noise is in them, such as a rumbling noise. I have a lot more gas and my urine has a strange smell. These problems continue today. Since the vaccine, I have had a diminished appetite, and have lost weight. Every morning I wake with a bad taste in my mouth. As of November 1, 2004, the following is happening to me: I now have over all my body, a tingling sensation (from head to my toes), an overall body stiffening. My face has a tingling numb sensation in it. As of November 7, 2004 I woke in the morning with very painful knee joints. I continue to have very painful hands. Both hands have sensations of numbness, burning, grainy feeling, coldness, stiffness, tingling, poor coordination, and joint pain. Overall, my body feels stiffer and weaker, and more tired than normally. My knee joints are aching and my toes feel numb and tingling and painful. I feel my nerves have been attacked by the vaccine. All of my daily and/or normal activities are affected by this extreme condition in my hands and body. I have had MS for over 10 years, and I know that these are not the type of symptoms I would experienced from MS. Given the time of onset of these symptoms (2 weeks after the vaccine was administered), I believe the vaccine has damaged my body.  As of Dec2004: My Dr has determined that these events (above) are not MS related I continue to suffer in my hands and feet.				Y					N	10/12/2004	10/25/2004	13	Nerve and Blood tests taken	OTH	PVT	Estriol 4mg (estrogen)	NONE	Multiple Sclerosis			1						1	Abdominal discomfort; Arthralgia; Asthenia; Coordination abnormal; Decreased appetite; Dysgeusia; Fatigue; Gastrointestinal hypermotility; Hypoaesthesia; Musculoskeletal stiffness; Myalgia; Nervous system disorder; Pain; Paraesthesia; Peripheral coldness; Skin burning sensation; Urine analysis abnormal; Weight decreased	FLU3~SANOFI PASTEUR~U1451AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231842	01/03/2005	LA	67.0	66		F	12/15/2004	Received Pneumovax vaccine 12/14/04 at 09:30AM Left deltoid, chills x one hour. Noticed reaction while trying on clothes today. Red area with swelling noted left deltoid region to forearm.				Y					U	12/14/2004	12/15/2004	1	NONE	PUB	PUB	UNK	NONE	NONE		LA041212	1						1	Chills; Injection site erythema; Injection site oedema; Injection site reaction	FLU3~SANOFI PASTEUR~U1531AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0605P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0231843	01/03/2005		32.0	32		M	09/10/2004	Developed alopecia in mid-Feb04 starting on both sides of head above the ears and spreading to approx 20 bald spots on top and back of scalp. Kenalog cream prescribed on 03Mar04. Received injections of 0.4cc of Kenalog in 2 spots on 31Mar04.									N	01/13/2004	02/16/2004	34	Test for diabetes/lupus negative	MIL	MIL						1						1	Alopecia	FLUX~UNKNOWN MANUFACTURER~~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~2~~RA~HEP B (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~1~~RA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0231844	01/03/2005	MA	9.0	9		F	12/23/2004	101 fever, stiff neck, cold symptoms x 48 hrs 8 days after FluMist.									Y	12/02/2004	12/10/2004	8		PVT	PVT	NONE	NONE	NONE	Sister~Influenza (Seasonal) (FluMist)~1~11.00~In Sibling		1						1	Musculoskeletal stiffness; Pharyngitis; Pyrexia; Rhinitis	FLUN3~MEDIMMUNE VACCINES, INC.~50035P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0231845	01/03/2005		20.0	19		M	11/10/2004	Rash on chest and arms, Atarax and Aveeno				Y					Y	10/15/2004	11/09/2004	25	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Rash	FLUX~UNKNOWN MANUFACTURER~U1501AA~3~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4020072~1~SC~~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0231846	01/03/2005	TX	3.0	3		M	12/23/2004	Redness, swelling of arm at injection site									U	12/21/2004	12/22/2004	1	NONE	PVT	PVT	Zithromax, Rondec DM	Left Otitis Media		swelling~Vaccine not specified (no brand name)~~0.50~In Sibling		1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1476AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231873	01/03/2005	MN	18.0	17		M	01/03/2005	Patient was playing basketball within a couple of hours of the shot. He was hit in the arm, in the exact spot that the shot was administered, during the game and the arm swelled up drasticly. In addition, he had to use his inhaler for a coincident breathing difficulty.  His swelling was quite a bit less, later in the evening.  He was fully recovered the next morning.  He wanted it said that he had a bit more bleeding than normal from the shot location, right after the needle was withdrawn. It stopped after a few minutes.									Y	12/10/2004	12/10/2004	0	none	UNK	UNK		none	He occasionally uses an inhaler for breathing difficulty.			1						1	Condition aggravated; Dyspnoea; Injection site abscess; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0231877	01/03/2005	AZ	59.0			F	01/03/2005	At injection site right deltoid local swelling size of baseball. Vital signs taken: 70/50  Pulse 52, no SOB, light headed with dizziness. Ice pack applied to site when swelling noted. Juice given. Client placed on exam table after resting for 15 minutes B/P 100/70. Client stated she felt better and left clinic by self.									Y	12/29/2004	12/29/2004	0		PUB	PUB						1						1	Dizziness; Hypotension; Injection site oedema	FLU3~SANOFI PASTEUR~U1568AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0213249	01/04/2005	OK	61.0	60		F	11/24/2003	After 5pm 11/13/03 broke out in hives, legs, trunk of body. Called PP was prescribed Medrol dose pack. (Received flu shot around 10am 11/13/03).				Y					Y	11/13/2003	11/13/2003	0		PUB	OTH	NONE	NONE	NONE		OK0351	1						2	Urticaria	FLU3~EVANS VACCINES~765852~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0231432	01/04/2005		70.0	70		F	12/30/2004	Information has been received from a pharmacist concerning a healthy 70 year old female who on 12/16/04 was vaccinated in the right deltoid with pneumococcal 23v polysaccharide vaccine (lot # 649913/0577P). The patient received a prior vaccination with pneumococcal 23v polysaccharide vaccine in 1994. Concomitant therapy included influenza virus whole virion 3v inactivated. On approximately 12/18/04 the patient developed redness in both arms and 2 red nodules on the lower portion of the right arm. She also developed sniffling and a stopped nose. Unspecified medical attention was sought, and the patient was treated with diphenhydramine hydrochloride. The patient's outcome was unknown. The reporter considered redness in both arms and 2 red nodules on the lower portion of the right arm to be other important medical events (OMIC). Additional information has been requested. Follow-up information has been received from a pharmacist; the patient self-treated with diphenhydramine hydrochloride (Benadryl) tablets, after experiencing the events. At the time of the report, she was recovering. Additional follow up information has been received from a pharmacist. On 12-17-2004 erythema and pruritus developed. It was reported that the event began with redness over the affected arm, then progressed over the patient's trunk, legs, and neck up to chin. A physician was consulted. The patient recovered at home. It was reported that the reaction lasted 12-13 days, and the patient recovered from erythema and pruritus on Dec 29, 2004.									U	12/16/2004	12/17/2004	1	UNKNOWN	OTH	OTH			Immunization		WAES0412USA02753	1						2	Erythema; Nasal congestion; Pruritus; Rhinorrhoea; Rhinorrhoea; Skin nodule; Injection site inflammation; Rash; Skin nodule; Erythema; Nasal congestion; Skin nodule	FLU3~SANOFI PASTEUR~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0577P~2~IM~UN~PNEUMO (PNEUMOVAX)~2|FLU3~SANOFI PASTEUR~U1559BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~0577P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~3|FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~4|PPV~MERCK & CO. INC.~0577P~2~IM~RA~PNEUMO (PNEUMOVAX)~4	USA		Influenza
0231432	01/04/2005	TX	70.0	70		F	12/22/2004	Patient, 12/21/04, reports bilateral inflammatory rash, swollen nodules on right arm; site of pneumococcal injection. Taking Benadryl. Patient recovering at home.									U	12/16/2004	12/18/2004	2		OTH	PUB		NONE	NONE			1						3	Erythema; Nasal congestion; Pruritus; Rhinorrhoea; Rhinorrhoea; Skin nodule; Injection site inflammation; Rash; Skin nodule; Erythema; Nasal congestion; Skin nodule	FLU3~SANOFI PASTEUR~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0577P~2~IM~UN~PNEUMO (PNEUMOVAX)~2|FLU3~SANOFI PASTEUR~U1559BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~0577P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~3|FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~4|PPV~MERCK & CO. INC.~0577P~2~IM~RA~PNEUMO (PNEUMOVAX)~4	USA		Influenza
0231883	01/04/2005	MO	50.0			F	12/30/2004	Information has been received from a physician concerning a 50 year old hospitalized female with community acquired pneumonia and no allergies who on approximately 12/20/04 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included an unspecified influenza virus vaccine, antibiotics and steroids. On 12/21/04 twelve hours after vaccination, the patient developed acute respiratory distress. Twenty four hours after vaccination, the patient was placed on life support with a ventilator. It was reported that the patient has not recovered. No product quality complaint was involved. Acute respiratory distress was considered to be immediately life threatening. Additional information has been requested. Per Follow up report received on 06/14/2005:  Patient still has not recovered.			Y	Y	Y				N	12/20/2004	12/21/2004	1	UNK	OTH	OTH	Antimicrobial; Corticosteroids		Community acquired pneumonia; Hospitalization		WAES0412USA02893	1						1	Respiratory distress	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~~~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0231887	01/04/2005	CA	70.0	70		F	12/20/2004	Guillain Barre Syndrome. Of note, questionable parent with questionable distant history of GBS after vaccine.    02/11/05 Received Discharge summary of 11/22-11/29/2004. FINAL DX: Guillain Barre syndrome records reveal patient experienced progressive weakness begining late Oct.  Developed foot drop & had falls w/elbow fx.  When seen in Ortho clinic for elbow fx, weakness of LEs noted & pt admitted.  Neuro consult done. Reflexes decreased.  Tx w/IVIG & steroids.  Minimal improvement.  Transferred to inpatient rehab.  Follow up 01/20/05: Patient has recovered from adverse event. 60 Day Follow up: severe leg weakness, requires walker.					Y	8			N	10/16/2004	10/26/2004	10	EMG abnormal	PVT	PVT	Detrol; Amoxicillin		Breast cancer; DM  PMH: type 2 DM w/peripheral neuropathy; breast cancer w/bilat mastectomies; OA; obesity; cataract extraction; TKR.  Allergy: sulfa, pneumo vaccine & other meds.  Family hx: GBS in both parents			1						1	Asthenia; Guillain-Barre syndrome	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0231888	01/04/2005	WI	68.0	68		M	12/16/2004	Patient admitted with SOB, general myalgia and malaise after flu shot; afebrile. No suggestion of CHF decompensation/ARF due to dehydration versus ACE-1. Mild flu induced by vaccine (viral syndrome)? ARF secondary to vol depletion due to viral syndrome? Thrombocytopenia due to viral syndrome?					Y				Y	10/27/2004	10/29/2004	2	10/29: Ser 5.4 baseline 4; WBC 4.3; K positive 5.8; Cardiac enzymes negative; 10/29: BNP 291; Platelets 62	UNK	UNK	Combivent; Furosemide; Catapress 2 patch weekly; Calcium; Norvasc; Prilosec; Dialyvite; Metoprolol;		CHF; 30 year smoker but has stopped; HTN; CRF; COPD: Anemia			1						1	Dyspnoea; Laboratory test abnormal; Malaise; Myalgia; Thrombocytopenia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0231892	01/04/2005	TX	1.19	1	.2	F		Patient presented on 12/20/04 with bruising and petechiae. Parents thought her symptoms had occurred for a least 1 week. She had a gastrointestinal virus (vomiting/diarrhea) per parental report 1.5 weeks before. She had thrombocytopenia (platelet count down to 8,000). Received MMR 11/5/04. 60 Day Follow Up: She has had normal platelet counts twice 1/25/05 and 2/25/05. Appears to have recovered.			Y	Y	Y	2			Y	11/05/2004	12/20/2004	45	CBC on 12/20/04.	PVT	PVT	NONE	URI; Resolved OM	Borderline Anemia			1						1	Contusion; Petechiae; Thrombocytopenia	FLU3~SANOFI PASTEUR~U1450AA~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0315P~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A67180A~2~~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0116P~1~~LL~VARICELLA (VARIVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0231893	01/04/2005	MN	1.91	1	.9	F	12/21/2004	Had first dose flu vaccine about 6 weeks ago. Within 2-3 days develop intermittent vomiting, mild diarrhea for 1.5-2 weeks. Otherwise well. Second dose flu shot 8 days ago. Within 2-3 days again, intermittent vomiting and diarrhea; worse in last 24 hours.									N	12/13/2004	12/15/2004	2	Stools culture; O&P pending; GI testing shows viral infection	PVT	PVT	NONE	NONE	NONE			1						1	Diarrhoea; Viral infection; Vomiting	FLU3~SANOFI PASTEUR~U1425AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231894	01/04/2005	WA	1.26	1	.3	F	12/30/2004	Patient received HIB #4, MMR #1, flu shot, and Prevnar. On 12/20/04, rash developed. 12/29, fevers off and on over last few days.									Y	12/20/2004	12/29/2004	9	NONE	PVT	PUB	NONE	NONE	Eczema; URI; OM			1						1	Pyrexia; Rash	FLU3~SANOFI PASTEUR~U1500~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE227AA~4~IM~~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~1050N~1~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A83578F~3~IM~~PNEUMO (PREVNAR)~1	USA		Influenza
0231895	01/04/2005	CA	9.0	9		M	12/15/2004	Fever to 104, nausea, lethargy within 1 hour of vaccine. Previously well.				Y					Y	12/08/2004	12/08/2004	0	WBC 15000	PVT	OTH	Albuterol; QUAR	NONE	Healthy boy with occasional asthma.			1						1	Lethargy; Nausea; Pyrexia; White blood cell count increased	FLU3~SANOFI PASTEUR~U1505AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231896	01/04/2005	WV	34.0	33		F	12/28/2004	Day of vaccine, burning and runny nose which progressed to a raw spot in nose with even more burning that would not subside. Occasional bleeding from right nose.				Y					Y	12/09/2004	12/09/2004	0		PUB	OTH		NONE	NONE			1						1	Burning sensation mucosal; Epistaxis; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500379P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0231897	01/04/2005	VA	1.0	1	.0	M	12/27/2004	Fever 1 day after shots; temperature max 102.4 for 3 days. Blanching erythema on chest and abdomen for 3 days. Mild diarrhea, mild cough and watery eyes.									Y	12/23/2004	12/24/2004	1	Negative Flu; Negative Strep; CBC WNL	PUB	PVT	NONE		NONE			1						1	Cough; Diarrhoea; Erythema; Lacrimation increased; Pyrexia	FLU3~SANOFI PASTEUR~U1484AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0509P~3~~RL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0764P~1~~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A74404K~4~~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0231898	01/04/2005	KY	50.0	50		F	12/23/2004	Rash, itching, numbness in mouth and tongue.				Y					Y	12/21/2004	12/21/2004	0		MIL	PVT						1						1	Hypoaesthesia oral; Pruritus; Rash	FLU3~SANOFI PASTEUR~U1561AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231899	01/04/2005	KY	42.0	41		F		Rash with itching; treated with over the counter Benadryl.									Y	12/17/2004	12/17/2004	0		MIL	PVT						1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U1561AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231900	01/04/2005	OK	72.0	72		M	12/22/2003	11/5/03 arm got hot and feverish and continued until 12/21/03. Got black and blue. Saw doctor 2 weeks ago.				Y					U	11/04/2003	11/05/2003	1		PUB	PUB		NONE	NONE		OK0354	1						1	Contusion; Feeling hot	FLU3~EVANS VACCINES~765852~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0231906	01/04/2005	OK	35.0	34		F	01/08/2004	Patient started itching at site given, then itching all over, face turned red.  Heart rate increased had petit mal seizures.				Y					Y	10/30/2003	10/30/2003	0	2 EGK's	PUB	UNK	Benadryl, Neurontin	NONE	Heart condition has supraventricular tachycardia, seizures		OK0402	1						1	Heart rate increased; Injection site erythema; Injection site hypersensitivity; Petit mal epilepsy; Pruritus	FLU3~EVANS VACCINES~TU5852~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0231907	01/04/2005	OK	44.0	43		F	12/30/2003	2 x 7 reddened, swollen area painful to touch.  Benadryl, Motrin. Site reaction at left arm.									Y	12/29/2003	12/29/2003	0		PUB	OTH					OK0401	1						1	Erythema; Injection site reaction; Pain; Swelling	FLU3~SANOFI PASTEUR~U1293AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0945N~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1|TTOX~SANOFI PASTEUR~U0998AA~UNK~~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0231908	01/04/2005	OK	9.0	9		F	12/23/2003	Seizure (first occurance) lasting 10 minutes, not treated with medication, required ER evaluation.				Y					Y	12/19/2003	12/22/2003	3	Head CT - normal CBC & CMP - normal	PVT	OTH	NONE	NONE	NONE		OK0356	1						1	Convulsion	FLU3~SANOFI PASTEUR~U1170AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231909	01/04/2005	OK	24.0	23		F	12/15/2003	Received vaccine (flu) lot # 765947 Evans 12/10/2003 RTC 12/11/2003 with approximately 1 1/2 inch induration - red & warm to touch.  Advised client to apply warm moist heat to site.  She states after 2 days the site was bruised and itching but swelling and redness were gone.									Y	12/10/2003	12/11/2003	1		PUB	PUB	Zoloft  Zanax	No	No		OK0353	1						1	Contusion; Erythema; Feeling hot; Pruritus; Swelling	FLU3~EVANS VACCINES~765947~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0231911	01/04/2005	OK	61.0	60		F	11/13/2003	48 hours after shot left arm began to ache from elbow - neck then head ache.  Had history of arm and shoulder problems in the past. 11/17/2003 follow up maybe I hurt it exercising.									Y	11/10/2003	11/13/2003	3		PUB	PUB	excedrin	NONE	Osteoarthritis		OK0347	1						1	Pain	FLU3~SANOFI PASTEUR~U1095AA~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231912	01/04/2005	OK	60.0	60		F	11/14/2003	Started with aching, fever and chills 24 hours after injection, followed by headache, burning eyes, nausea and diarrhea.  Local reaction - swollen knot at site tender and warm for 5 days followed by rash on face - vesicular which is resolving.  Saw physician on 11/12/2003.  States he felt that symptoms including rash were related to flu shot.				Y					Y	11/03/2003	11/04/2003	1	Blood pressure checked.	PUB	PUB	Clonazepam, Geodon, Lexapro, Phentermine	NONE	Hypertension		OK0346	1						1	Diarrhoea; Eye irritation; Feeling hot; Headache; Injection site pain; Injection site swelling; Nausea; Pain; Pyrexia; Rash vesicular	FLU3~EVANS VACCINES~765852~7+~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0231913	01/04/2005	OK	59.0	59		M	10/28/2003	Took flu shot and left office - 10-15 minutes later developed (while driving) tremor and lost consciousness for about 2 minutes just prior to this noted burning and swelling (size of golf ball) around injection site.  Proceeded back to health department and then to hospital ER where he was treated with Benadryl and released home.  Told not to take flu vaccine in future. Medical Records received on 1/20/2005 states pt experienced allergic reaction, seizure, and diaphoresis.				Y					Y	10/27/2003	10/27/2003	0	CT of head, blood glucose, CBC, all within normal limits. Medical Records received on 1/20/2005 states EKG abnormal.	PUB	PUB	Lortab ASA Oral hypoglycemre Glocovance	No	Diabetes Mellitus		Ok0345	1						1	Convulsion; Electrocardiogram abnormal; Hyperhidrosis; Hypersensitivity; Injection site reaction; Injection site swelling; Loss of consciousness; Skin burning sensation; Tremor	FLU3~SANOFI PASTEUR~U1095AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231914	01/04/2005	OK	49.0	49		F	11/04/2003	Swelling, redness, site warm, pain on side of neck, low grade temperature.									Y	10/10/2003	10/12/2003	2		PUB	PUB	Metaprolol Estrace Nasacort Prolex D Zyrtec		Allergies Palpitations		OK0342	1						1	Erythema; Feeling hot; Neck pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U1092AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231915	01/04/2005	OK	62.0	61		F	10/29/2003	Got flu vaccine 10/24/2003 20 minutes later numbness in face and left arm and down left leg - could not talk improved by end of day - having numbness in face and fingertips only today 10/29/2003. Medical records received on 1/13/2005 states pt experienced facial numbness, speech slurred, and clumsiness.				Y					Y	10/24/2003	10/24/2003	0		PUB	PUB			Medical Records received on 1/13/2005 states chest pain, low back pain, and chronic lung disease.		OK0341	1						1	Hypoaesthesia; Hypotonia; Speech disorder	FLU3~SANOFI PASTEUR~U1095AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231916	01/04/2005		49.0	49		F	12/20/2004	Febrile reaction following flu and pneumovax immunization, with a temperature greater than 102, localized ecchymotic reaction of shoulder at injection site, myalgia, and arthralgia. She missed work 2 days due to this illness. Febrile illness, possible adverse drug reaction.				Y					U	12/08/2004	12/08/2004	0	On 12/10/04 Urinalysis, CBC, AST Reported with enclosed copy of office visit progress note.	UNK	UNK	Ibuprofen		Back to work afebrile 10/13/04.			1						1	Arthralgia; Injection site haemorrhage; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1488AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0706P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0231917	01/04/2005		44.0	44		F	12/28/2004	Received flu shot approximately 11 am on 12/27/04 at 13:30 got extremely flushed and hot. Her pulse was 138, B/P was 148/92 and 100% oxygen saturation. The left side of her neck was numb feeling and flushed. She felt that she was having heart palpitations that lasted at 40 minutes at the above rate at rest, then her pulse remained around 113 until the AM. Also felt like throat getting narrow. Called health nurse, she didn't feel this was caused by injection and instructed to take tylenol.									U	12/27/2004	12/27/2004	0		UNK	UNK	Vaccine in employee health lock up.		History of asthma. Has taken flu shot in the past with no problems. Allergies to PCN and Sulfa.			1						1	Hot flush; Hypoaesthesia; Palpitations; Throat tightness	FLU3~SANOFI PASTEUR~U1553AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231940	01/04/2005	OK	42.0	42		F	11/19/2003	Received vaccines at 4:30 PM. Pain in left arm started at 5 PM. Reports aching and burning throughout night. 5 AM 11/11/03, client went to ER with complaints of severe pain in left arm. Continues to complain of severe pain 11/19/03. Was treated with IV fluids, Demerol, Nitro. Rx given for Lortab and Protonix.				Y					N	11/10/2003	11/10/2003	0	NONE	PUB	PUB	NONE	NONE	Allergic to Bentyl; Scoliosis		OK0349	1						1	Pain; Thermal burn	FLU3~SANOFI PASTEUR~U1095AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0820~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0231960	01/04/2005	TN	40.0	39		F		Low grade fever of 99.1 while taking Tylenol. Site of injection red at about 20cm and swollen the size of a baseball. Also blisters on side of tongue the length of .5cm. Pinpoint blisters on tongue and throat.				Y					Y	12/29/2004	12/30/2004	1	NONE	PVT	OTH		NONE	NONE			1						1	Injection site erythema; Injection site swelling; Oral mucosal blistering; Pyrexia	FLU3~SANOFI PASTEUR~U1568AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231961	01/04/2005	KY	46.0	45		M	12/29/2004	Rash Hives. Doctor told pt. to take Benadryl.									Y	12/22/2004	12/23/2004	1		UNK	UNK		none	none		KY2005001	1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~U1410BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231972	01/05/2005	WI	0.5	0	.5	F	12/30/2004	The pt was noted to be more sleepy then it was on day after shots. Approx 4/1/04. Parents noted pt would stare off into space shortly after waking in AM. Also happened while eating and diaper changes about 1x1 day. Cold symptoms reported at same time. No fever. No unusual baby movements or color changes. Pt would snap out of it with stimulation. Exam 4/8/04 normal. Occurred daily from 4/1/04-4/9/04 and never since. This pt's mom notes developed slower than brother but still reached milestones at appropriate ages.									Y	03/10/2004			EEG done on 04/14/04 read as normal, staring episodes had stopped as of 4/9/04.	PVT	PVT	NONE	NONE	Prenatal borderline hydrocephalus, resolved by time of head CT scan, 1/7/04, increased muscle tone defect in lower extremities at 1 month exam.  on 11/15/2003.			1						1	Gaze palsy; Pharyngitis; Rhinitis; Somnolence	DTAP~SANOFI PASTEUR~C1680AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~X0566~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231974	01/05/2005	SC	72.0	72		F	01/05/2005	Telephone call from patient.  Complaint of left arm discomfort with administration of influenza vaccine. Experienced increasing soreness. Was painful to rest on left side that evening following vaccination.  Not red, swollen, or feverish.  States arm has continued to be sore, particularly in joint.  Has normal strength, but uncomofrtable to raise left arm overhead.  Patient to see her private MD on 111-22-04 for routine exam.  Plans to ask him to evaluate.									U	10/16/2004	10/16/2004	0		UNK	UNK	NONE	NONE	arthritis in back - no medication required		SC0449	1						1	Arthralgia; Discomfort; Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U1394DA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231975	01/05/2005	SC	74.0	74		F	01/05/2005	Patient received influenza vaccine on 12/8/04 in right arm.  On 12/15/04 unable to move right arm without severe pain (on scale of 1-5 with 5 being the highest, patient rates pain at 5)									U	12/08/2004	12/15/2004	7	NONE	UNK	UNK	NONE	NONE	NONE		SC0450	1						1	Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U1532AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0685N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0231979	01/05/2005	MN	5.0	4		F	01/05/2005	Developed intermittent vomiting and diarrhea 1 1/2- 2weeks duration.									Y	11/09/2004	11/12/2004	3		UNK	UNK	NONE	NONE	NONE			1						1	Diarrhoea; Vomiting	FLU3~SANOFI PASTEUR~U1425AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231980	01/05/2005	MD	0.07	0	.1	F	01/05/2005	Cough, chills, body aches, headache, tiredness (extreme.)									N	01/03/2005	01/04/2005	1	None	UNK	UNK		none	none			1						1	Chills; Cough; Fatigue; Headache; Pain	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0231981	01/05/2005	SC	72.0	71		F	01/05/2005	(Right arm)site is erythematous, hot, painful X 6 days.  Pain into shoulder joint of right arm.									Y	12/22/2004	12/22/2004	0	NONE	UNK	UNK	NONE	NONE	NONE		SC0451	1						1	Injection site erythema; Injection site pain; Injection site warmth; Shoulder pain	FLU3~SANOFI PASTEUR~U1394DA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0685N~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0231983	01/05/2005	WI	60.0	60		M	01/03/2005	States My arm (Rt.) was sore from shoulder to elbow - area throbbed - went to urgent care center - received and took anti-inflammatory med. x 3-4 days - better after that.				Y					Y	12/21/2004	12/24/2004	3		UNK	UNK		None known	None known			1						1	Pain	FLU3~SANOFI PASTEUR~U1512AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0231985	01/05/2005	CA	53.0	52		M	12/28/2004	By evening not feeling well. Vomited but no fever. Ate dinner later and went to bed. In AM noted red raised circles on Flu shot arm but disappeared after 3 1/2 hours became pale and nauseated, diarrhea, cold sweats, felt like she was going to pass out, laid down slept 2 hours felt fine after nap.									Y	12/27/2004	12/28/2004	1	NONE	PUB	PUB	NONE		Hod Glans lymphoma		CA040117	1						1	Diarrhoea; Dizziness; Hyperhidrosis; Injection site erythema; Injection site swelling; Malaise; Nausea; Pallor; Somnolence; Vomiting	FLU3~SANOFI PASTEUR~U1566AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231996	01/06/2005	TX	66.0	65		F	01/06/2005	About 13 hours after the shot, patient had the following symptoms: Shaking,  Could not get warm enough Chills Body aches									Y	01/05/2005	01/05/2005	0		UNK	UNK	Cozar and Lipitor	no	no			1						1	Chills; Feeling cold; Pain; Tremor	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|PNC~PFIZER\WYETH~~UNK~~~PNEUMO (PREVNAR)~1	USA		Influenza
0231998	01/06/2005	MA	82.0	81		M	01/06/2005	Patient received flu vaccination around 11:00 AM on Thurs., Nov. 18, 2004. He developed a shaking fever by 5 PM. He saw his doctor the next day and was put on cipro. The fever persisted and he was admitted to hospital on Sunday. He had extensive cardiac w/up (s/p MI about 20 years ago)and treated for CHF. Both staph and strep were detected in blood cultures. Hospitalized for one week, including ICU. Medical Records received on 2/14/2005 states wheezing and CHF. Discharge Summary received on 2/7/2005 states urinary frequency, tracheobronchitis, renal failure, pleural effusion and infection bacterial.			Y	Y	Y	7	Y		Y	11/18/2004	11/18/2004	0	Staph and strep in blood cultures. Medical Records received on 2/9/2005 states leukocytosis and creatine increased.	UNK	UNK	Warfarin, lisinopril, diltiazem, baby ASA	None. Discharge Summary received on 2/2/2005 states URI.	S/P MI about 20 years ago. Medical Records received on 2/14/2005 states Serratia Marcescens history, weight loss, colitis, phlebitis, carcinoma skin, and fatigue. Discharge Summary received on 2/2/2005 states carcinoma kidney, asthmatic bronchitis, pseudomonas, tracheobronchitis, BPH, peripheral neuropathy, hypothyroid, palpitations, atrial fibrialltion, hypertension, and obesity.			1						1	Bacterial infection; Cardiac failure congestive; Creatinine renal clearance decreased; Laboratory test abnormal; Leukocytosis; Pleural effusion; Pollakiuria; Pyrexia; Renal failure; Sepsis; Tracheobronchitis; Tremor; Wheezing	FLU3~SANOFI PASTEUR~U1560AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0232000	01/06/2005	MI	66.0	65		F	12/22/2004	12 Hours after pneumonia/flu injection felt sick 24 hours after Pneumonia/flu injection very sick with increased reddness in arm with chills and ached all over. Was given the injection on Dec 8th and was seen at the Dr office on Dec 20th				Y					Y	12/08/2004	12/08/2004	0	Diagnosed with serum sickness	UNK	UNK	Didronel 400 MG 14days every 3 months. Premarin 0.9 premarin cream.  Azmacort MDI Allergia 60Mg everyday. many OTC vitamins	No	Erythromycin PCN Dexamethasone			1						1	Chills; Injection site erythema; Malaise; Pain; Serum sickness	FLU3~SANOFI PASTEUR~U1555AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0512P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0232002	01/06/2005	MS	0.87	0	.9	F	10/29/2004	Patient received (2) flu shots-Fluzone PO.25mg IM(L) thigh and Fluzone O-5 ml (R) thigh accidently No adverse reaction noted. Child peaceful and sleeping on mom's shoulder.									Y	10/28/2004	10/28/2004	0	Mom took patient to Emergency rm  unknown test done	UNK	UNK	none	none	NKDA		MS04018	1						1	Medication error	FLU3~SANOFI PASTEUR~U1392AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232003	01/06/2005	CA	79.0	78		M	01/06/2005	Cutaneous pruritic maculopaular rash initially to injection site.  progressed to bilateral upper extremities and upper torso.  Few scattered vesicles to extremities.  Treated with prednisone 40mg/day for 5 days.  Much improved at this time, 3 days into course.									Y	12/30/2004	12/31/2004	1	none	UNK	UNK	lipitor ASA	none	Atrial Fibrillation Hyperlipidemia C2 odontiod fracture 11/2004			1						1	Blister; Injection site hypersensitivity; Injection site rash; Pruritus; Rash maculo-papular	FLU3~SANOFI PASTEUR~U1549AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232004	01/06/2005	NY	0.54	0	.5	F	01/06/2005	Non tender, moveable, firm 7 cm area at site of Pediarix vaccine in left thigh  Symptomatic treatment									Y	12/02/2004	12/02/2004	0		UNK	UNK	Lasix ASA	none	Tricuspid altresia Large VSD, Hypoplastic R heart Mild CHF Glenn Procdure			1						1	Injection site induration	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A015AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1391AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0805P~1~IM~LL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~A5762A~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0232011	01/06/2005	NY	1.01	1	.0	F	01/05/2005	Erythematous vesicular rash 5 days after vaccine.				Y					Y	12/22/2004	12/27/2004	5		PVT	PVT			Recurrent OM			1						1	Erythema; Rash vesicular	FLU3~SANOFI PASTEUR~U1379AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0561N~3~~RL~HIB + HEP B (COMVAX)~1|IPV~SANOFI PASTEUR~W0816~3~~RL~POLIO VIRUS, INACT. (IPOL)~1|VARCEL~MERCK & CO. INC.~0072P~1~~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0232012	01/06/2005	CA	27.0	27		F	01/05/2005	By noon 12/15/04, felt nauseated with a mean HA, took ibuprofen. 0200 12/16/04, vomited; 0500 18/16/2004 felt like my head was going to burst, 1100 12/16/04 unable to get out of bed, chills, diaphoretic, dry heaving- drank Gatorade darkened room, 12/17/04 still had HA 12/18/04 HA resolved.									Y	12/15/2004	12/15/2004	0	NONE	PUB	PUB	NONE	NONE	PCN		GA04122	1						1	Chills; Headache; Hyperhidrosis; Nausea; Retching; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500340P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0232016	01/06/2005	GA	53.0	52		F	01/06/2005	Client given Flu vaccine at 10:20. Client called at 10:30 c/o swelling at injection site. Client returned to clinic 10:35. Ice pk applied to site. 15 mins on and 15 mins off x 2. Swelling reduced.									N	01/06/2005	01/06/2005	0		PUB	OTH	Lipitor, Climara patch		Migraine HA, high cholesterol			1						1	Injection site oedema	FLU3~SANOFI PASTEUR~U1459AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0231432	01/07/2005	TX	70.0	70		F	01/05/2005	From initial information received on 1/4/05 regarding an adverse event occurring in the USA, it was reported that a 70 year old female patient received a Fluzone vaccination, lot number not reported, administered IM, and a second dose of Pneumovax 23, lot number 649913/0577P, administered IM in the right deltoid on 12/16/04. On approximately 12/18/04, the patient developed redness in both arms and two red nodules on the lower portion of her right arm. She also developed sniffling and a stopped nose. Unspecified medical attention was sought and the patient was treated with diphenhydramine hydrochloride. The patient's recovery status was unknown. The reporter of this case considered the redness in both arms and the two red nodules on the lower portion of the right arm to be other important medical events (OMIC).				Y					U	12/16/2004	12/18/2004	2		OTH	OTH			The pt's medical history is significant for immunization. She received a dose of Pneumovax 23 in1994.		200500011	1						4	Erythema; Nasal congestion; Pruritus; Rhinorrhoea; Rhinorrhoea; Skin nodule; Injection site inflammation; Rash; Skin nodule; Erythema; Nasal congestion; Skin nodule	FLU3~SANOFI PASTEUR~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0577P~2~IM~UN~PNEUMO (PNEUMOVAX)~2|FLU3~SANOFI PASTEUR~U1559BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~0577P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~3|FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~4|PPV~MERCK & CO. INC.~0577P~2~IM~RA~PNEUMO (PNEUMOVAX)~4	USA	Emergency room visit	Influenza
0232023	01/07/2005	NC	44.0	43		F	12/22/2004	This is a non-serious spontaneous case from a consumer or other non-health professional in the USA of BURNING IN JOINTS. The reporter causality is not related to FluMist. This case is submitted according to the VAERS accelerated reporting agreement for FluMist. This is a spontaneous case report sent by a consumer that refers to a female aged 43 years. The patient's past medical history included auto immune thyroid disease, Grave's disease, and Hashimoto disease. She also had a viral infection several days prior to receiving FluMist. She received FluMist on 12/16/04 at 2 in the afternoon. The patient's concomitant medication included Levothyroxine Sodium. On 12/18/04 at approximately 6 in the evening, the patient's had complaints of intense burning and pain in her joints which caused loss of mobility. The reporter stated the pain at rest was rated a 4 and increased to an 8 with movement. The burning and pain began in the patient's wrist and ankles. Subsequently the burning and pain spread to her hands, arms, and legs. On 12/19/04, the patient was prescribed Naproxen for treatment. The reporter stated the Naproxen alleviated the patient's symptoms enough to rest that evening. On 12/20/04, the patient presented in the physician's office and was diagnosed with a viral infection. The reporter stated the attending physician concluded the events were due to the viral infection and not related to FluMist.									N	12/16/2004	12/18/2004	2		PVT	PVT	Synthroid	Viral infection	Auto Immune Thyroid; Graves Disease; Hashimoto Disease		MEDI0002621	1						1	Arthralgia; Arthritis; Hypokinesia; Pain; Viral infection	FLUN3~MEDIMMUNE VACCINES, INC.~500357P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0232024	01/07/2005	FL	45.0	45		F	12/17/2004	This is a non serious spontaneous case from a nurse in the USA of PAPULAR RASH. The reporter causality is related to FluMist. This case is being submitted according to the VAERS accelerated reporting agreement for FluMist. At approximately 8:30 AM on 12/8/04, a 45 year old female received FluMist intra-nasally and developed a very fine rash on her neck and chest the following morning. She had linear papulae on her neck and the rash was slightly itchy. As of 12/15/04, the rash was beginning to resolve after use of hydrocortisone cream for treatment. The reporter determined the events to be definitely related to FluMist. The patient has not yet recovered.									N	12/08/2004	12/09/2004	1		PVT	PVT	Prozac				MEDI0002598	1						1	Pruritus; Rash papular	FLUN3~MEDIMMUNE VACCINES, INC.~500352P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0232025	01/07/2005	UT	36.0	36		F	01/05/2005	Vertigo, chills, sweats.									Y	11/09/2004	11/10/2004	1	NONE	PVT	PVT		NONE	NONE			1						1	Chills; Hyperhidrosis; Vertigo	FLU3~SANOFI PASTEUR~U1456AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232026	01/07/2005	HI	0.76	0	.8	M	12/30/2004	Urticaria, 2-3 hours after vaccination, with flu shot broke out in hives.									Y	12/28/2004	12/29/2004	1	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1416AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232028	01/07/2005	NC	76.0	76		M	11/11/2004	10/11/2004 2:00PM, Resident received Flu injection.  5:00PM resident was having some jerking, chills and fever.  Doctor notified.  Dr. said to monitor and give Tylenol 500 mg (2) for fever and comfort.  7:10PM temp. decreased to 103.2 - Family in.  8:00PM temp. 100.7 - patient rested all night.									Y	10/11/2004	10/11/2004	0		OTH	UNK		Parkinson's Disease				1						1	Dyskinesia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0232029	01/07/2005	NY	83.0	82		F	01/05/2005	4 hours after receiving Flu shot in arm and pneumonia booster in right arm, arm swelled from elbow to shoulder.  Later in day and during night, pain.  Next day patient applied ice.  3rd day went to doctor at 10:00AM.  Doctor told patient she had staph infection.  Prescribed cefaoroxil 500 mg for 7 days.  Swelling and pain gone.  5 days later terrible sore throat.  Refilled prescription and as of 01/05/2005, still on meds.									Y	12/20/2004	12/20/2004	0		PUB	UNK		NONE	NONE			1						1	Bacterial infection; Pain; Pharyngolaryngeal pain; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0232030	01/07/2005	AL	59.0	58		F	12/09/2004	Noticed sore, painful area under left arm, down arm and breast area.  Then rash developed short distance from injection site, below the deltoid, going under the arm, then breast area , on back, neck up into the hairline.  Denies fever, complaint of nausea and being very tired.  Has history of chronic head and aches.  Did not notice any change in headaches.   12/09/2004 Patient presented to health department for public health nurse to see rash.  Patient had rash (looked like hives) from just below the lower part of her bra up to her neck and some in hairline at back of head.  Had one area on back between shoulder blades approximately size of small orange.  The front chest area was pretty much covered up to the neck with a few areas on neck.  Public health nurse recommended patient see MD for evaluation of rash.  Patient unable to take Benadryl. 12/10/2004 Received phone call from patient stated she went to Pri-Med and saw MD who definitely thought patient had had a reaction to either the flu shot or to the Pneumonia shot.  Patient was given a cortisone injection at doctor's office and was given Claritin for Hives.  Patient states rash and symptoms are a lot better today.				Y					Y	12/07/2004	12/08/2004	1	NONE	PUB	PUB	Actonel Zocor Premarin	NONE	Allergic to Penicillin, Keflex, Codeine.  Has Osteoporosis, high cholesterol.  No birth defects.		AL0429	1						1	Fatigue; Headache; Nausea; Pain; Pyrexia; Rash; Urticaria; Vaccination complication	FLU3~SANOFI PASTEUR~U1531A~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0604N~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0232036	01/07/2005	WI	1.3	1	.3	F	12/30/2004	There was a 2-3 cm ovoid patch of erythematous induration with vessicles and papules within, noticed on 12/17/2004.									U	12/08/2004	12/17/2004	9	NONE	PVT	UNK		Cough for 5 to 6 weeks.	NONE			1						1	Erythema multiforme; Injection site induration	DTAP~SANOFI PASTEUR~U1290BA~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1380AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A83578K~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0075P~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0232046	01/07/2005	VA	1.31	1	.3	F	01/07/2005	MILD GENERALIZED RASH ON TORSO AND FACIAL AREA STARTING ON 1/6/05.				Y					U	12/29/2004	01/06/2005	8	NONE	UNK	UNK	DIMETAPP	COLD SYMPTOMS FOR 2 DAYS PRIOR TO VISIT, NO FEVER.				1						1	Rash	FLU3~SANOFI PASTEUR~U1427AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE394AA~4~IM~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0316P~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A57561K~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0232049	01/07/2005	AK	39.0	38		M	01/07/2005	Patient received Typhoid and Flu shot on 6 Jan 05, Patient stated puffiness both eyes, difficult to focus vision, difficulty sleeping.  Came into clinic as a walk in at 1300 almost 24 hours after shots given.  Still having focus problems. Patient currently taking Naproxen, Flexeril									U	01/06/2005	01/06/2005	0		UNK	UNK						1						1	Eye swelling; Insomnia; Visual disturbance	FLU3~SANOFI PASTEUR~U1557AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~SANOFI PASTEUR~X0521~UNK~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0232056	01/07/2005	WI	49.0	49		F	01/07/2005	Patient experienced fever myalgia and pain at the injection site 2 days after injection of the vaccine. A temperature of 103 was reported and arthralgia but no cough, vomiting, diarrhea or abdominal pain. The patient's temperature in the office on 12/20/2004 was 102.5, she was noted to have an area of ecchymosis 4 inches in diameter at the injection site. There was no fluctuance, lymphadenopathy, icterus or rash.									U	12/08/2004	12/10/2004	2	Urinalysis on 12/10/ was Normal, CBC: WBC 12400, RBC 4.85. HGH 43.9, Plat: 242k, Neut 77%, Lymph 13%, EOS 0.3, Monos 8.8%. Basos 0.9%, AST 23	PVT	PVT	NONE	NONE	NONE			1						1	Arthralgia; Injection site haemorrhage; Injection site pain; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1488AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0706P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0232051	01/08/2005	TX	57.0	57		F	01/08/2005	Within the first 24 hours I developed a large, red inflamed area about 4 from top to bottom, at the site of the injection (right arm).  It became very red with a raised surface and very warm to the touch.  I took two Advil and two doses of Benadryl 25 mg each, and it has subsided somewhat, but is still sore 72 hours later.									U	01/05/2005	01/05/2005	0	None as of this date	UNK	UNK	Zoloft, Atenolol, Elavil, Lorazepam, Librax, Restasis eye drops	None	No significant allergies previously diagnosed.			1						1	Injection site erythema; Injection site inflammation; Injection site pain; Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0232054	01/10/2005		20.0			M	01/10/2005	Patient is a 20 year old male who was vaccinated on 28 Dec 04 with the vaccinia virus.  He reports having severe body aches and fevers to 101.5 and headaches.   Nine days after vaccination he began to have headaches with subsequent vomiting.  He reports 5-6 episodes of emesis over the next 12-24 hours.  No blood.  He also complains of feeling weak and tired for the next 48 hours.  He reports the headaches lasted for four days and have since resolved in the last 12 hours.  The vaccination site was also the worst at that time with redness, tenderness, swelling, and oozing of the site.  Approximately 2 days prior to the headaches and peak of symptoms, he noticed small bumps scattered on arms, legs, back and chest.  One of the bumps on same upper arm as the vaccine developed into a blister.  The others continued with papules only.  In the last 12 hours his headaches have improved, the vaccination site has improved, no further vomiting, strength is slowly returning but the rash not improved.  Currently no fevers or chills, no vomiting, no diarrhea, headache is gone.  No sick close contacts MEDICATIONS: 1. Motrin  Supplements: None  No over-the-counter medications   PMH: 1. None  MED ALLERGIES: 1. NKDA   Social History Never smoked  No pets  No allergies  No history of problems with vaccines				Y					U	12/28/2004	01/09/2005	12	No tests	MIL	MIL	None	None	None			1						1	Asthenia; Blister; Fatigue; Headache; Injection site abscess; Injection site erythema; Injection site pain; Injection site swelling; Pain; Pyrexia; Rash; Rash maculo-papular; Vomiting	FLU3~SANOFI PASTEUR~U1457AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020072~1~~RA~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~X0862~UNK~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0232064	01/10/2005	GA	43.0	43		F	01/10/2005	Pt states FluMist taken approx 1330 on Jan 8, 2005.  Mid morning Sunday stomach/bloating/bad gas, queasy feeling began.  Headache then started took 2 Advils and about 1330 on her head hurt so bad that by 3pm she started vomiting. Then around 5 pm chills began 101 temp reported by pt. Diarrhea began. Headache still present. Taking Tylenol/Advil every 4-6 hours. Woke up today called in sick. I referred her to her doctor. Stated she understood.									U	01/08/2005	01/09/2005	1	N/A	MIL	MIL			Scarcoid 1992			1						1	Abdominal distension; Chills; Diarrhoea; Flatulence; Headache; Nausea; Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500365~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0232065	01/10/2005	CA	57.0	56		F	01/10/2005	A facial rash appeared within a couple of hourse. This rash went down both sides of my face and across my chin with raised bumps. It burned, but did not itch. It lasted for about 2 weeks. I did nothing for the first days and then the clinic told me to take Benadryl and that worked within about 4 days.									Y	12/17/2004	12/17/2004	0	none	UNK	UNK	Maxcide and Timoptic XE (I filled in #14 in error--only one flu shot in 2004 and no prior reactions to flu shots) I have been taking flu shots for at least 10 years	None	Allergic to feathers, sensitive to sulfa, high blood pressure and glaucoma.			1						1	Rash erythematous; Skin burning sensation	FLU3~SANOFI PASTEUR~U1438AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232066	01/10/2005	VA	25.0	24		F	01/10/2005	Very sore, inflamed throat, runny nose, headache, stiff neck, fatigue.									U	01/07/2005	01/09/2005	2		UNK	UNK	Vitamins, folic acid, flax seed oil.	none	none			1						1	Fatigue; Headache; Musculoskeletal stiffness; Pharyngolaryngeal pain; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0232067	01/10/2005	WA	81.0	81		M	01/10/2005	Approximately 2 -3  days after flu shot, patient started having pain - mainly lower torso, upper thighs, groin area - No longer has pain but now has progressed to vertigo like symptoms - weakness, equilibrium - can't walk, confusion, nausea, losing weight - Dr has done blood tests, 2 Ct's, chest x-ray, ekg and nothing abnormal - Information from medical records states pale, nausea,fatigue, dizziness.				Y					U	10/26/2004	10/29/2004	3		OTH	UNK	Blood pressure meds, i.e. enapril	none	Hypertension Information from Medical records includes aneurysm and divertculitis. msv			1						1	Abasia; Asthenia; Balance disorder; Confusional state; Dizziness; Nausea; Pain; Pallor; Vertigo; Weight decreased	FLU3~SANOFI PASTEUR~U1504AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0232070	01/10/2005	MA				M	01/06/2005	From initial information received on 1/4/05 from a health care professional regarding an adverse event occurring in the USA, it was reported that a male patient in his 50's received a dose of FLUZONE administered on an unspecified date. The lot number, route and site of administration were not reported. Four hours later, the patient experienced a severe hypoglycemic attack. Per the reporter, he refused to be transferred to the hospital. Twelve hours later, the patient had a cardiac arrest and was found dead. Reportedly, the patient had Type I Diabetes, but was non-compliant. Discharge Summary received on 1/20/2005 states past ischemic injury and myocardial fibrosis.	Y	01/03/2005							N					UNK	UNK			The patient's pre-existing medical conditions include Type I Diabetes. Reportedly, the patient is non-compliant.		200500058	1						1	Cardiac arrest; Hypoglycaemia; Myocardial fibrosis; Myocardial ischaemia; Blood glucose increased; Hypoglycaemia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1442AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0232071	01/10/2005	AR	0.51	0	.5	M	01/09/2005	Within minutes of receiving immunizations, developed marked respiratory depression, bradycardia, and fiery red macular rash on face, body and upper legs. Responded to stimulation; increased heart rate and respirations. Taken to ER and placed on monitor and Pulse oximetry. Given steroids and Benadryl. Admitted for observation.				Y	Y	1			Y	12/29/2004	12/29/2004	0	CBC normal; RAST; Egg yolk and Egg white negative.	PVT	PVT	NONE	NONE	Ventricular septal defect			1						1	Bradycardia; Erythema; Heart rate increased; Rash macular; Respiratory depression; Respiratory rate increased	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A015AA~3~~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1380AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A57562A~3~~RL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0232072	01/10/2005	SD	71.0	70		M	12/29/2004	Vaccine failure. Discharge Summary received on 1/25/2005 states pt experienced fever, chills, headache, cough, SOB, loss of consciousness, hypotension, increased BUN, and increased creatinine.				Y	Y	1			Y	10/12/2004	12/20/2004	69		PVT	OTH	UNK	NONE	NONE		SD05002	1						1	Blood creatinine increased; Blood urea increased; Chills; Cough; Drug ineffective; Dyspnoea; Headache; Hypotension; Loss of consciousness; Pyrexia	FLU3~SANOFI PASTEUR~U1278AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0232074	01/10/2005	NY	39.0	38		M	01/05/2005	face/neck/ears reddened. Welts on forehead. Itching right ear, neck, back				Y					Y	01/05/2005	01/05/2005	0		OTH	OTH			Hep C+  Previous Insulin Dependent Diabetes			1						1	Erythema; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1529CA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0232075	01/10/2005	TN	82.0	81		F	12/15/2004	Severe pain in left arm within 2 hours of having injection. Began having swelling, redness and warmth in arm. Entire upper arm edematous. Went to MD today and was prescribed cephalexin. Arm continues to be red and edematous but edema has settled in the elbow area also reports running a low grade temp.				Y					Y	12/13/2004	12/13/2004	0	NONE	PUB	OTH	ASA daily, Zocor 20mg 1 daily, Lopressor 30mg 1 daily, Synthroid 7.5mg 1 daily	NONE			TN04069	1						1	Feeling hot; Injection site erythema; Injection site oedema; Oedema peripheral; Pyrexia	FLU3~SANOFI PASTEUR~U1569AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0692P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0232076	01/10/2005	TN	7.0	7		M	12/06/2004	Pt states he received flu shot on 12/1/04. On 12/2/04 at 1:10PM c/o severe pain in L knee. Treated with ice pack and rest. At 2:30PM c/o severe pain in both knees. Denied pain at injection site in right arm. Mother was called and child was picked up from school. On 12/3/04 child states in AM and PM that he had no pain and that he received Tylenol at home.									Y	12/01/2004	12/02/2004	1		PUB	PUB		NONE	Asthma		TN04068	1						1	Arthralgia	FLU3~SANOFI PASTEUR~U1558AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232077	01/10/2005	TN	5.0	4		F	01/04/2005	Child had petit mal seizure immediately after injection was given.				Y					Y	01/03/2005	01/03/2005	0	Child will be having studies done by private doctor	PUB	OTH	NONE	NONE	NONE, has sibling that has seizures			1						1	Petit mal epilepsy	FLU3~SANOFI PASTEUR~U1505AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0232078	01/10/2005		21.0			F		This is a non-serious spontaneous case from a healthcare professional in the USA reporting that a medical support member had ACCIDENTAL EXPOSURE to FLUMIST while vaccinating military personnel. The reporter determined the events to be unrelated to FLUMIST administration. This case is submitted according to the VAERS accelerated reporting agreement for FLUMIST. An unidentified medical support member developed headache and scratchy throat after accidental exposure during FLUMIST administration. Investigation into these events resulted in no definitive reason why the FLUMIST was responsible for these symptoms. The reporter determined the events to be unrelated to FLUMIST vaccination. Further information has been requested. Follow up - This is a non-serious spontaneous case from a healthcare professional reporting that a medical support member had ACCIDENTAL EXPOSURE to FLUMIST while vaccinating military personnel. The reporter determined the events to be unrelated to FLUMIST administration. This case is submitted according to the VAERS accelerated reporting agreement for FLUMIST. An unidentified medical support member developed headache and scratchy throat after accidental exposure during FLUMIST administration. Investigation into these events resulted in no definitive reason why the FLUMIST was responsible for these symptoms. HEPA filters were put into the environment and since then, nobody has gottensick. The patient has recovered. The reporter believes military personnel that were vaccinated with FLUMIST were already sick and hence may have caused the individuals administering FLUMIST to have headache and scratchy throat. The reporter will not give patient identifiers regarding this patient. The reporter determined the events to be unrelated to FLUMIST vaccination. Additional information received on 05Jan05 and 19Jan05 incorporated into above narrative.									Y		12/01/2004			MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0002636	1						1	Headache; Medication error; Pharyngolaryngeal pain; Headache; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~500356P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500356P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0232079	01/10/2005		54.0			M	05/04/2005	This is a non-serious spontaneous case from a healthcare professional in the USA reporting that a medical support member had ACCIDENTAL EXPOSURE to FLUMIST while vaccinating military personnel. The reporter determined the events to be unrelated to FLUMIST administration. This case is submitted according to the VAERS accelerated reporting agreement for FluMist. An unidentified medical support member developed headache and scratchy throat after accidental exposure during FLUMIST administration. Investigation into  these events resulted in no definitive reason why the FLUMIST was responsible for these symptoms. The reporter determined the events to be unrelated to FLUMIST vaccination. Further information has been requested. Additional information receved on 05JAN05 and 19JAN05 incorporated into above narrative. Additional information received on 04MAY05: patient name, gender and DOB , vaccine lot number.									Y		12/01/2004			MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0002635	1						1	Accidental exposure; Headache; Throat irritation	FLUN3~MEDIMMUNE VACCINES, INC.~500356P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0232080	01/10/2005		26.0			M	05/04/2005	This is a non-serious spontaneous case from a healthcare professional in the USA reporting that a medical support member had ACCIDENTAL EXPOSURE to FluMist while vaccinating military personnel. The reporter determined the events to be unrelated to FluMist administration. This case is submitted according to the VAERS accelerated reporting agreement for FluMist. An unidentified medical support member developed headache and scratchy throat after accidental exposure during FluMist administration. Investigation into these events resulted in no definitive reason why the FluMist was responsible for these symptoms. The reporter determined the events to be unrelated to FluMist vaccination. Further information has been requested. Follow up received states - This is anon-serious spontaneous case from a healthcare professional reporting that a medical support member had ACCIDENTAL EXPOSURE: (Unlabelled) to FLUMIST while vaccinating military personel. The reporter determined the events to be unrelated to FLUMIST adminstration. This case is submitted according to the VAERS Safety Surveillande accelerated reporting agreement for FLUMIST. A 26 year old male medical support member developed headache and scratchy throat after accidental exposure during FLUMIST adminsitration. Investigation into these events resulted in no definitive reason why the FLUMIST was responsible for these symptoms. HEPA filters were put into the environment and since then, nobody has gotten sick. The patient has recovered. The reporter believes military personnel that were vaccinated with FLUMIST were already sick and hence may have caused the individuals administering FLUMIST to have headache and scratchy throat. The reporter determined the events to be unrelated to FLUMIST vaccination. Additional information received on 05Jan05 and 19Jan05 incorporated into above narrative. Additional information received on 04May05: patient name, gender and DOB; vaccine lot number									Y		12/01/2004			MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0002634	1						1	Headache; Medication error; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~500356P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0232081	01/10/2005		48.0			M	05/04/2005	This is a non-serious spontaneous case from a health care professional reporting that a medical support member had ACCIDENTAL EXPOSURE to FluMist while vaccinating military personnel. The reporter determined the events to be unrelated to FluMist administration. This case is submitted according to the VAERS accelerated reporting agreement for FluMist. An unidentified medical support member developed headache and scratchy throat after accidental exposure during FluMist administration. Investigation into these events resulted in no definitive reason why the FluMist was responsible for these symptoms. The reporter determined the events to be unrelated to FluMist vaccination. Further information has been requested. Follow up - A 48 year old male medical support member developed headache and scratchy throat after accidental exposure during FLUMIST admisitration. Investigation into these events resulted in no definitive reason why the FLUMIST was responsible for these symptoms. HEPA filters were put into the environment and since then, no body has gotten sick. The patient has recovered. The reporter believes military personnel that were vaccinated with FLUMIST were already sick and hence may have caused the individuals administering FLUMIST to have headache and scrarchy throat. The reporter determined the events to be unrelated to FLUMIST vaccination. Additional information received on 05Jan05 and 15Jan05 incorporated into above narrative. Additional information received on 04May05: patient name, gender and DOB; vaccine lot number.									Y		12/01/2004			MIL	MIL	COncomitant Drug (s) Not Reported				MEDI0002631	1						1	Headache; Medication error; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~500356P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0232082	01/10/2005		64.0			F	05/04/2005	This is a non-serious spontaneous case from a healthcare professional reporting that a medical support member had ACCIDENTAL EXPOSURE to FluMist while vaccinating military personnel. The reporter determined the events to be unrelated to FluMist administration. This case is submitted according to the VAERS accelerated reporting agreement for FluMist. A 54 year old female medical support member developed headache and scratchy throat after accidental exposure during FluMist administration. Investigation into these events resulted in no definitive reason why the FluMist was responsible for these symptoms. HEPA filters were put into the environment and since then nobody has gotten sick.  The patient has recovered. The reporter believes army personnel that were vaccinated with FluMist were already sick and hence may have caused the individuals administering FluMist to have headache and scratchy throat. The reporter determined the events to be unrelated to FluMist vaccination. Further information has been requested. Additional informatio received on 05Jan05 and 19Jan05 incorporated into above narrative. Additional information received on 04May05; patient name, gender and DOB; vaccine lot number.									Y		12/01/2004			MIL	MIL	Concomitan Drug (s) Not Reported				MEDI0002637	1						1	Headache; Medication error; Pharyngolaryngeal pain; Headache; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~500356P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500356P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0232083	01/10/2005		34.0			M	05/04/2005	This is a non-serious spontaneous case from a healthcare professional in the USA reporting that a medical support member had ACCIDENTAL EXPOSURE to FluMist while vaccinating military personnel. The reporters determined the events to be unrelated to FluMist administration. This case is submitted according to the VAERS accelerated reporting agreement for FluMist. A 34 year old male  medical support member developed headache and scratchy throat after accidental exposure during FluMist administration. Investigation into these events resulted in no definitive reason why the FluMist was responsible for these symptoms.  HEPA filters were put into the environment and since then, nobody has gotten sick. The patient has recovered. The reporter believes army personnel that were vaccinated with FluMist were already sick and hence may have caused the individuals administering FluMist to have headache and scratchy throat. The reporter determine the events to be unrelated to FluMist vaccination. Further information has been requested. Additional information recevied on 05Jan05 and 19Jan05 incorporated into above narrative. Additional information received on 04May05; patient name, gender and DOB, vacine lot number.									Y		12/01/2004			MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0002638	1						1	Headache; Medication error; Pharyngolaryngeal pain; Headache; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~500356P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500356P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0232102	01/10/2005	CA	68.0	67		M	12/29/2004	Patient called today 12/29/04 states that after one week of having vaccines of PPV23, right arm swollen with pain, redness, and hot to touch. Patient was seen at hospital and states his right arm MD. Diagnosis of cellulitis after the Pneumonia shot. Patient was given medication at hospital per his statement.									U	12/16/2004	12/27/2004	11	NONE	PUB	PUB		NONE	NONE		CA040123	1						1	Cellulitis; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1556AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0486P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0232103	01/10/2005	AZ	0.57	0	.6	M	01/10/2005	Child had 3 generalized seizures first on Saturday 1/8. Third one witnessed in clinic 1/10 at 1:10 PM (unresponsive, tonic, eyes to one side for 3 minutes). Referred to pediatric neurology and to be admitted.									Y	01/04/2005	01/08/2005	4		PVT	PUB						1						1	Coma; Convulsion; Eye disorder	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A008AA~3~~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1468AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A67180C~3~~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0232108	01/10/2005	IN	1.01	1	.0	F	01/07/2005	Fever 102 started 12/24. Maculopapular rash 12/26 - 12/30.				Y					Y	12/14/2004	12/24/2004	10	NONE	PVT	PUB	NONE		NONE			1						1	Pyrexia; Rash maculo-papular	FLU3~SANOFI PASTEUR~U1342AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0347P~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0232070	01/11/2005	MA	51.0	50		M	01/10/2005	Patient had hypoglycemic reaction several hours after receiving flu shot. His sugar of 12 was taken at home by EMTS. He declined hospitalization. Several hours later, he was found dead at home by his wife.	Y	12/17/2004							N	12/17/2004	12/17/2004	0	Diabetic with history of many hypoglycemic episodes. Had a hypoglycemic reaction several hours after receiving a flu shot.	PVT	UNK		NONE				1						2	Cardiac arrest; Hypoglycaemia; Myocardial fibrosis; Myocardial ischaemia; Blood glucose increased; Hypoglycaemia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1442AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0232109	01/11/2005	IL	69.0	69		F	01/11/2005	Next day following flu shot, pt. developed severe headache, which became worse.  On 12/23 she called Dr. who ordered Butalbital.  Pt. is improving.									U	12/20/2004	12/21/2004	1		UNK	UNK	Routine meds for HTN, bladder, hormones, stomach.	no	Hx of hypertension, migranes, allergic to iodine.			1						1	Headache	FLU3~SANOFI PASTEUR~U1553AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232112	01/11/2005	CO	50.0	50		M	10/28/2004	On 10/25 dx'd with shingles given oral medication. Pt. said sore started below elbow on left arm, like an infected hair about 4 hrs after flu shot. Got to the size of a penny by bedtime. Next am had bump like that on left shoulder. Over weekend turned to blisters that scabbed over.  Denies pain. 10/29 getting better - no pain.									Y	10/25/2004	10/25/2004	0	none	UNK	UNK	Advair for COPD				CO04019	1						1	Blister; Herpes zoster	FLU3~SANOFI PASTEUR~1378AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232116	01/11/2005	OH	49.0	49		M	01/11/2005	Pt. had flu symptoms, sinus, malaise, and congestion post immunization on 8 Jan 05.									Y	01/08/2005	01/08/2005	0	none	MIL	MIL	none	no	no			1						1	Influenza like illness; Malaise; Nasal congestion; Sinusitis	FLUN3~MEDIMMUNE VACCINES, INC.~500356P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0232128	01/11/2005	MI	1.34	1	.3	M		Patient received an influenza vaccine and an MMR vaccine on 11/30/04 and then on 12/9/04 he had a prolonged (1 hour) seizure and a fever after the seizure.				Y	Y	1			Y	11/30/2004	12/09/2004	9	EEG pending neurology referral.	PVT	OTH	NONE	NONE	NONE			1						1	Convulsion; Pyrexia	FLU3~SANOFI PASTEUR~U1416AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0317P~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Hospitalisation	Influenza
0232130	01/11/2005	AK	63.0	62		M	11/01/2004	Received flu and pneumonia shots 10/12/04. May have had pneumonia shot before. Not sure. Left arm very sore, red, swollen shoulder to 1 inch above elbow. Feverish first night. Painful to touch.									Y	10/12/2004	10/12/2004	0	NONE	PUB	PUB	UNK	NONE	UNK		AK200502	1						1	Erythema; Pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U1377AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0232131	01/11/2005	AK	22.0	22		F	11/18/2004	Immunizations at 2:30 PM. Five minutes after administration, client reports itching at site, dizziness, difficulty breathing, tight throat. 0.3ml epinephrine SC below immunization site. EMT alerted. No audible wheezing or stridor. EMT arrived to transport at 2:50. Administered O2 by mask, IV fluids. Assessed and evaluated, observed at hospital. Given 50mg Benadryl; symptoms elevated. Anaphylaxis undetermined by physician and referred to own physician. Released to home at 7:30 PM. Information from medical records fails to confirm anaphylaxis, does state panic attack. msv				Y					Y	11/10/2004	11/10/2004	0		OTH	PUB	Tegretol; Depakote		Seizure disorder		AK200506	1						1	Dizziness; Dyspnoea; Injection site hypersensitivity; Panic reaction; Pruritus; Throat tightness	FLU3~SANOFI PASTEUR~U1381AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0232132	01/11/2005	AK	0.74	0	.7	F	12/21/2004	Fever developed about 4 hours after vaccination, as high as 104 rectally. Twitching lasting only about 15 seconds, not repeated. Fever not controlled with Acetaminophen. Now on Ibuprofen and Acetaminophen alternating. History of pertussis exposure 4 weeks ago. Coughing and vomiting lasting only a few days; not cultured. No treatment.									Y	12/20/2004	12/20/2004	0	12/21/04 Fever 102-103 today	OTH	PUB	NONE	NONE	NONE	Screaming 4 hours after vaccination lasting 4-5 hours.~DTaP + HepB + IPV (Pediarix)~1~0.80~In Patient	AK200511	1						1	Cough; Muscle twitching; Pyrexia; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A001AA~3~IM~~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1416AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A74404A~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0232133	01/11/2005	HI	67.0	67		F	01/02/2005	Wheezing at 9:00 AM and dizziness evening and morning.									Y	12/30/2004	12/31/2004	1		UNK	UNK						1						1	Dizziness; Wheezing	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0232134	01/11/2005	MN	51.0	51		U		Since shot on 10/14/04 left arm has been very sore at night time, symptoms: lying on back or site with left arm up it will ache a lot. Pain will extend down arm and into hand during nighttime. Through Dec04 arm seems to have bothered more and disturbs sleep some nights.									U	10/14/2004				PUB	PVT						1						1	Injection site pain; Insomnia	FLU3~SANOFI PASTEUR~U1417AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232135	01/11/2005	CA	64.0	64		F	01/04/2005	2 hours after administration of influenza vaccine, patient developed diffuse rash across chest. Later broke out in forearm of same arm as vaccine site.									U	01/03/2005	01/04/2005	1	NONE	PVT	PUB	Toprol	NONE	HTN; Tobacco dependence			1						1	Rash	FLU3~SANOFI PASTEUR~U1556AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232136	01/11/2005	NY	49.0	48		F	01/07/2005	Patient received flu shot at 10:30 AM. At 11:30 AM, reported generalized itching; taken to ER. Treated with Benadryl and Prednisone orally. Released from ER at 3 PM.				Y					Y	01/06/2005	01/06/2005	0		OTH	PVT		NONE	Lung disease; Allergy to Penicillin			1						1	Pruritus	FLU3~SANOFI PASTEUR~U1530AB~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0232137	01/11/2005	NY	55.0	54		F	01/04/2005	Patient came with complaints of allergic reaction to flu vaccine administered on 12/6/04. Patient complained of itchy rash at injection site. Patient returned to clinic 1/3/05 for treatment. Urticaria noted by patient within 1 hour of injection flu vaccine. 1/3/05 Treated for generalized rash.									U	12/06/2004	01/03/2005	28		PUB	PUB		NONE	History of migraine; HTN; Gastritis			1						1	Injection site hypersensitivity; Injection site rash; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1501AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232138	01/11/2005	MA	1.25	1	.2	F	01/04/2005	On 12/15 noticed red, big pimple which became back following day. Also about 6cmx4cm redness around, tender, swollen. Seen 12/17 with necrotic, black center about 1cm diameter. All in exact site of varicella injection. Treated with Augmentin and Acyclovir PO.				Y					Y	12/03/2004	12/16/2004	13	NONE	PVT	PUB	Zithromax; Motrin		Allergy to Amox and Omnicef			1						1	Acne; Erythema; Necrosis; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U1496AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1315N~1~SC~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0232168	01/11/2005					F	12/23/2004	Child had facial twitching and redness of the face, neck and chest. Given 3/4 teaspoon of Benadryl.									Y	12/22/2004	12/22/2004	0	NONE	MIL	MIL		NONE	NONE			1						1	Erythema; Muscle twitching	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A00BAA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U151AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A57561K~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0232171	01/12/2005	NY	81.0	81		F	01/12/2005	Two weeks after vaccination had tingling in hands/fingers, numbness/tingling in feet/toes. Increased to point where she could not walk. Admitted to hospital with Dx of GBS by Neurologist. She is receiving IgG Rx.   05/11/05 Received Discharge summary of 1/3-1/11/2005. FINAL DX: GBS  Patient experienced LE paresthesias & unsteady gait. Neuro & Cardio consults & LP done.  Abnormal gait & areflexia.  Treated with IVIG, improved slowly, and d/c to inpatient rehab.       Follow up 03/24/05: Patient's recovery status unknown. Lost to follow up outside of hospitalization.					Y	40			U	11/19/2004	12/03/2004	14	Contact private Neurologist  LABS: abnormal EMG.  CSF protein elevated.  BUN increased.  CXR.  Holter monitor.	UNK	UNK	Synthroid Pravachol	None	Allergic to Penicillin Discharge summary states Hx of GERD and hypothyroid.			1						1	Abasia; CSF test abnormal; Gait disturbance; Guillain-Barre syndrome; Hypoaesthesia; Paraesthesia	FLU3~SANOFI PASTEUR~U1479AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0232172	01/12/2005	DE	35.0	35		F	01/12/2005	Severe headaches with sensitivity to light/sound. Congestion, sore throat and runny nose. Lump/pain at injection site.  Symptoms lasted for about 10-11 days.  I took different medications to get relief (alkaseltzer plus cold and sinus, Sudafed, Tylenol Migraine, DayQuil, Nyquil, Motrin, Excedrin Migraine.  Medicine took edge off, but only lasted 2 hours and headache never went away during those 2 hours. Did not report problem to sick call.									Y	12/20/2004	12/20/2004	0	None	MIL	MIL	None at time of injection	None	Seasonal Allergies			1						1	Headache; Injection site mass; Injection site pain; Nasal congestion; Pharyngolaryngeal pain; Photophobia; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1515AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~UNKNOWN MANUFACTURER~W1366~1~IM~LA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0232173	01/12/2005	TN	6.0	5		F	01/12/2005	Patient recieved influenza vaccine on 1/10/05 around 4:15 p.m. and had two seizures at home later that p.m. Patient has history of seizures and is on medication for this diagnosis, actually had levels done by neurologist last week and were notified they were low so the depakote was just increased per mother to doctor when she phoned her back on 1/11/05 in response to mother's call to us on 1/11/05 informing us of the seizure.  Doctor does not think the influenza vaccine precipitated the seizure but requested we complete the reporting process anyways. Change in dosage was also mentioned during the visit on 1/10/05.									Y	01/10/2005			Depakote level was low per neurologist/mother.	UNK	PUB		none	h/o epilepsy/seizure disorder, ADHD			1						1	Condition aggravated; Convulsion	FLU3~SANOFI PASTEUR~U1439AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232174	01/12/2005	VA	73.0	72		F	01/12/2005	Woke up the morning after receiving the flu shot with swollen neck glands, difficulty swallowing, severe  malaise, dry cough.  Denies fever, hives, sore throat or other swollen glands. Gradually resolved over the next 2 weeks.  According to client, she called her physican, who said it was from the flu shot but since he didn't give it he didn't need to see her.  No treatment other than Tylenol.									Y	12/12/2004	12/13/2004	1	N/A	UNK	UNK	Unknown	None	Unknown - no problem with previous flu shots			1						1	Cough; Dysphagia; Lymphadenopathy; Malaise	FLU3~SANOFI PASTEUR~U1560AB~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232176	01/12/2005	IN	38.0	38		M	01/12/2005	Received Flu Mist via nose on Jan 8, 2005.  After about 24 hours, began flu-like symptoms.  After 2 days, more significant flu-like symptoms (fever, chills, aches, etc.)  After 3 days, very significant symptoms causing loss of work.									U	01/08/2005	01/09/2005	1		MIL	MIL	NONE	NONE	NONE			1						1	Chills; Influenza like illness; Pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0232177	01/12/2005	MI	0.56	0	.6	F	01/12/2005	Child broke out in a raised red rash beginning 48 hours after vaccination over both legs, arms and trunk, also beginning to form on her face. Temp. is 100.8 axilary. Child has been on amoxicillin for ear infection since last week. Has appointment with pediatrician tomorrow for weight check.									U	01/10/2005	01/12/2005	2		UNK	UNK	None listed	Ear infection				1						1	Pyrexia; Rash erythematous	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~21928B2~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1516AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE274AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A74404B~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0232178	01/12/2005	IN	58.0	57		F	01/12/2005	Complained of skin feeling hot and on fire after receiving flu shot.  No fever.  Was out-of-town, so self-treated with Benadryl, which helped.  Lasted approximately 2 days.  After burning sensation went away, skin felt tender to touch.									Y	12/27/2004	12/28/2004	1	None  Patient did not seek medical attention.	UNK	UNK	None known	None	None			1						1	Skin warm; Tenderness	FLU3~SANOFI PASTEUR~U1559AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232179	01/12/2005	NY	1.68	1	.7	M	01/12/2005	Child was found dead early AM about 16-20 hours after the flu vaccine second dose 0.25ml. Child was fine when went to bed. Happy playful and no respiratory difficulty. Autopsy report received on 2/16/2005 states SIDS.	Y	01/09/2005							N	01/08/2005	01/09/2005	1	Autopsy by coroner.	PVT	PVT	NONE	NONE	Bronchitis treated with Zithromax on 12/28/04.			1						1	Sudden infant death syndrome; Fatigue	FLU3~SANOFI PASTEUR~U1411AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1411AA~2~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0232185	01/12/2005	CA				F	11/17/2004	Received telephone call at clinic from the patient, who stated the flu shot she received caused left arm pain, a golf ball sized nodule and some loss of function in left arm. Could not get response for further information, referred her to her physician.									U	11/14/2004	11/14/2004	0		PUB	PUB						1						1	Hypokinesia; Injection site nodule; Pain	FLU3~SANOFI PASTEUR~U1519AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232187	01/12/2005	MA	81.0	81		F	01/06/2005	Both arms and legs are achy. Generalized pain keeps her awake at night									Y	11/17/2004	11/19/2004	2	? Arthritis	PUB	PUB	unknown		unknown			1						1	Arthritis; Pain; Hypoaesthesia; Joint range of motion decreased; Pain; Paralysis	FLU3~SANOFI PASTEUR~U1448AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0232188	01/12/2005	MA	71.0	70		F	01/04/2005	Case described flu like reaction occurring within several hours of receiving vaccine. Arm sore - appetite ruined. Next day - okay.									Y	12/09/2004	12/09/2004	0		PUB	PUB			Allergic to demerol			1						1	Anorexia; Influenza like illness; Pain	FLU3~SANOFI PASTEUR~U1516AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232189	01/12/2005	TX	61.0	61		F	01/12/2005	Doctor reports allergic reaction, red streaks going down the arm, raised erythema of lower arm. No reaction at site of injection.				Y					U	01/11/2005	01/12/2005	1		PUB	PVT						1						1	Erythema; Hypersensitivity; Cellulitis; Erythema; Hypersensitivity; Injection site reaction; Oedema; Pain	FLU3~SANOFI PASTEUR~U15598A~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0709P~UNK~~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~41559BA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0709P~1~~UN~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0232190	01/12/2005	VT	12.0	12		F	01/06/2005	Vaccine given 12/01/2004 12/11/2004 - eye irritation, vomited and URI symptoms. 12/12/2004 - right side of face drooping. 12/12/2004 - seen ER Dx: Bell's Palsy				Y					Y	12/01/2004	12/11/2004	10		PVT	PUB		upper respiratory infection				1						1	Eye irritation; Facial palsy; Upper respiratory tract infection; Vomiting	FLU3~SANOFI PASTEUR~01457AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0232191	01/12/2005	OR	10.0	10		F	01/06/2005	Pt received flu vaccine 01/04/2005 - on 01/05/2005 pt developed a 3 welt, red and hot to touch. No fever, good ROM. We were notified 01/06/2005. Advised to try tylenol, cold compress. Follow-up 01/07/2005 if not better.									U	01/04/2005	01/05/2005	1		PVT	PVT						1						1	Erythema; Feeling hot; Urticaria	FLU3~SANOFI PASTEUR~U1451AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232210	01/13/2005	OR	84.0	84		F	01/07/2005	Cardiac arrest with CPR/cardioversion and ICU care for 5 days. Discharge Summary received on 1/12/2005 states pt experienced ventricular fibrillation and was unresponsive.	Y	01/04/2005							N	12/30/2004	12/30/2004	0		OTH	OTH	Enalapril; HCTZ	NONE	Hypertension; Allergy to penicillin			1						1	Anaphylactic reaction; Apnoea; Cardiac arrest; Coma; Hyperglycaemia; Hypokalaemia; Leukocytosis; Liver function test abnormal; Myocardial infarction; Oedema peripheral; Pneumonia; Stupor; Tongue oedema; Ventricular fibrillation; Dyspnoea; Loss of consciousness; Malaise; Pulse absent	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1443AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0232216	01/13/2005	AL	64.0	63		F	01/06/2005	Pt had flu shot in morning, has had flu shots before with no problems, not allergic to eggs. Had no symptoms until evening while eating supper blisters formed at back and top of mouth and started swelling. Called her sister because concerned about breathing. Sister came immediately. Blister broke and bled about 1/2 cup blood, no other symptoms or swelling. Pt went to ER, ER did not know what caused blister. Pt saw an oral surgeon the next day and he said it might have been flu shot. Pt would not give name of the doctor. Called pt to make sure she was ok she said yes, the blister is healing. She said who the oral surgeon was. He gave her amoxicillin, prednisone, and nystatin mouth wash.				Y					Y	01/03/2005	01/03/2005	0		PUB	UNK			Takes Toprol for blood pressure, Lopid for Cholesterol and Ambien at night			1						1	Blister; Oedema	FLU3~SANOFI PASTEUR~U1531AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0232222	01/13/2005	MD	63.0	62		M	01/13/2005	About 15 minutes after receiving the vaccine, while driving, developed a severe case of dizziness and felt flush.  Only lasted about 2 minutes.  Later that day, developed a headache									Y	01/12/2005	01/12/2005	0		UNK	UNK						1						1	Dizziness; Flushing; Headache	FLUX~UNKNOWN MANUFACTURER~unknown~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0232223	01/13/2005	KY	0.91	0	.9	M	01/13/2005	Two days after receiving influenza vaccine the child developed a rash around his mouth.  Mother reports that he also became nauseated and began vomiting. Reports that he also developed diarrhea at this time. Reports that she took him to his physician two days later and was diagnosed with egg allergy by blood testing.  No medication was provided by physician or any further treatment. Family has now moved and may be reached at the above cell phone number.				Y					Y	12/01/2004	12/03/2004	2	Blood testing	UNK	UNK	None at this time	None at the time of vaccine.	Eczema.			1						1	Diarrhoea; Hypersensitivity; Nausea; Rash; Vomiting	FLU3~SANOFI PASTEUR~U1559BA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0232225	01/13/2005	KY	73.0	72		M	01/13/2005	Pain, swelling, and redness at the site of the pneumonia shot and going down arm. He received pneumovax 1/11/05 ,developed the above has been going down but still there,he denies fever and chills. Hx pneumovax in the past with no side effects,denies itching at the site.  Previous is copied from physician note. Arm appeared swollen about half way from elbow to wrist, with erythema.				Y					Y	01/11/2005	01/12/2005	1		UNK	UNK						1						1	Erythema; Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U479AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~05790~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0232227	01/13/2005	WA	51.0	51		F	01/13/2005	Injection given 1/10/05 - swelling and redness about 2.5 inches on 1/11/05 - additional swelling, redness and warmth to touch late 1/12/05 and 1/13/05 to double in size. On 1/13/05 patient was sent to be seen in the ER for tmt of symptoms				Y					Y	01/10/2005	01/11/2005	1	N/A	UNK	UNK		N/A	N/A			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1558AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0232230	01/13/2005	ME	1.34	1	.3	M	01/13/2005	PATIENT DEVELOPED GIANT HIVES BILATERALLY ON LEGS AND TORSO, SIX HOURS POST INJECTION OF DOSE NUMBER TWO OF INFLUENZA VACCINE.				Y					Y	01/12/2005	01/12/2005	0		UNK	UNK		NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1558AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0232231	01/13/2005	VA	60.0	60		M	01/13/2005	Monday, December 20, 2004 patient received his flu shot.  On Wednesday, December 22, 2004 he began having symptoms of tingling and numbness in hands and feet, severe sensitivity to cold (tap water felt icy), tightness in leg muscles, tightness in chest, shortness of breath, unable to stand at times, unable to walk at times, headache, severe upper back pain.  He was admitted to hospital on December 25, 2004 through the ER.  He received MRIs, EMG, numerous blood tests.  On Tuesday, December 28, 2004 the back pain was tolerable and walking with assistance.  The doctors said it was a clinical diagnosis and discharged him to home without any medications.  The evening of December 28, 2004 the pain returned.  He was admitted to another hospital through the ER on Wednesday, December 29, 2004.  The severe pain persisted.  MRIs, flat plate of abdomen, spinal tap, blood tests were done.  Spinal tap showed high protein levels in the spinal fluid and a definite diagnosis of Guillain-Barre Syndrome was determined. Pain finally became managable and pt was discharged to home on Wednesday, January 12, 2005 with pain medication, Prednisone, Nexium and Duragesic patch and Physical Therapy.   2/7/05 Medical Records of 12/29/2004-1/11/2005 received.   FINAL DX: Guillain Barre syndrome Records state pt experienced HA & tingling in toes on 12/22/04 that progressed to back pain, stumbling and spincter control diminished.  Admitted to outlying hospital 12/27-12/27, Neuro & cardio consults done, MRI of brain & spine WNL, EMG mildly abnormal, but pt improved & d/c to home.  Then back pain acutely worsened, paresthesias of LEs continued & readmitted to higher level of care.  Neuro consult & LP done.  Reflexes decreased.  Improved & d/c to inpatient rehab.			Y	Y	Y	14			U	12/20/2004	12/22/2004	2	Spinal tap done showed high protein levels in spinal fluid.  EMG testing showed nerve damage.   Medical Records received on 2/7/2005 states CSF abnormal: protein 79(H), c/s neg.  MRI spine c/w degenerative changes.	UNK	UNK	Coumadin Voltarin	NONE  Healthy, well nourished 60 year old white male	aspirin allergy thrombophebitis  PMH: DVT & PE, LBP w/discectomy, vitreous hemorrhage, TKR, recovering alcoholic.			1						1	Back pain; CSF test abnormal; Chest discomfort; Dyspnoea; Faecal incontinence; Gait disturbance; Guillain-Barre syndrome; Headache; Hypersensitivity; Hypoaesthesia; Hypokinesia; Musculoskeletal stiffness; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0232233	01/13/2005	MT	40.0	40		F	01/13/2005	Dizziness, difficulty breathing, wheezing, paleness, weak, fast heart beat. This occurred about an hour after being administered the flumist vaccine. I was told by nurse that even if I have asthma I could still have vaccine as long as I'm taking medication for asthma.									N	01/12/2005	01/12/2005	0		UNK	UNK		None	Asthma, Hypothyroidism			1						1	Asthenia; Dizziness; Dyspnoea; Heart rate increased; Pallor; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0232238	01/13/2005	PA	60.0	59		M	01/13/2005	Patient experienced fever, cough and seizure. Discharge Summary received on 2/7/2005 states SOB and myalgia. Medical Records received on 2/7/2005 states atelectasis.					Y	5			Y	11/30/2004	01/08/2005	39	Positive Influenza A. Medical Records received on 2/7/2005 states hyperglycemia.	PVT	UNK	Advair; Prednisone	NONE	NONE. Discharge Summary received on 2/7/2005 states COPD, diabetes, and hyperlipidemia. Medical Records received on 2/7/2005 states CVA, tobacco addiction, fx of ribs, vertabra.			1						1	Atelectasis; Convulsion; Cough; Drug ineffective; Dyspnoea; Hyperglycaemia; Influenza; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1500AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0232245	01/13/2005	KS	25.0	24		F	01/13/2005	Redness, warmth, and fever 2 days after vaccine.									Y	01/11/2005	01/13/2005	2	Lymphangitis	MIL	MIL	Claritin, Singular and Motrin	NONE	History of seasonal allergies and Asthma.			1						1	Erythema; Feeling hot; Lymphangitis; Pyrexia	FLU3~SANOFI PASTEUR~U1555AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0986P~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0168616	01/14/2005		70.0	70		F	10/10/2002	A report was received from a foreign regulatory authority on 4/3/01 concerning a 70 year old female patient who experienced influenza-like symptoms and an SLE reaction, which resulted in hospitalization on 10/7/00 after receiving the Fluvirin vaccine. The patient had a history of essential thrombocytosis and hypertension. The patient had experienced symptoms of malaise, myalgia, fever, and nausea in conjunction with the influenza vaccination for several years. The patient was received felodipine, propranolol, aspirin, bendrofumethiazide and hydroxycarbamide concomitantly. On 10/2/00, the patient received the Fluvirin vaccine. On 10/7/00, the patient experienced influenza like symptoms and a SLE reaction. She developed the same symptoms as with previus vaccinations but her complaints increased. She had peaks of fever, symptoms from the lungs and hepatic influence. Investigation showed symptoms similar to SLE. She improved quickly after treatment with unspecified corticosteroids. The patient recovered without sequelae from the influenza like symptoms but the SLE reaction is persisting. The reporter assessed the relationship of the Fluvirin vaccine to the Influenza like symptoms as probable due to connection in time and similar cases and to the SLE reaction as possible due to similar cases.					Y				Y	10/02/2000	10/07/2000	5		UNK	UNK	Plendil; Inderol; Hydrea; Trombyl		Pyrexia; Nausea; Vomiting; Disorders of Muscle, Ligament, and Fascia		PJP200100182	1						2	Immune system disorder; Influenza like illness; Malaise; Myalgia; Nausea; Pyrexia	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Hospitalisation	Influenza
0169247	01/14/2005		7.0			M	10/10/2002	A report was received from a health professional on 4/9/01 concerning a 7 year old male patient who experienced flu-like symptoms, severe nausea, vomiting, and lethargy 1 day after receiving the Fluvirin vaccine, IM, on 3/1/01 (batch # E73100LA) which lead to hospitalization. The patient has a relevant medical history of sickle cell disease. The patient received a dose of Prevnar concomitantly. On 3/2/01 the patient experienced a syndrome of events including flu-like symptoms, severe nausea/vomiting, and lethargy for the duration of one week. The patient was not fully ambulatory and required inpatient hospitalization. The reporter was unsure of the duration of hospitalization. The patient was eventually discharged without further complications. After this adverse experience the physician noticed that his current stock of Fluvirin vaccines had partially crystalized. The reporter noted that the storage temperature was 33 degrees F, below the recommended 36-46 degrees F for this product. It was recommended that the remainder of the physician's stock be discarded. There was insufficient information to determine the causality assessment of the reporter.					Y				Y	03/01/2001	03/02/2001	1		UNK	UNK			Sickle Cell Anemia		PJP200100267	1						2	Influenza like illness; Lethargy; Nausea; Vomiting	FLU3~EVANS VACCINES~E73100LA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PNC~PFIZER\WYETH~~UNK~~~PNEUMO (PREVNAR)~2	USA	Hospitalisation	Influenza
0174952	01/14/2005		43.0	42		M	10/10/2002	A report was received from a health professional on 05/01/2001, concerning a 43 year old male patient who experienced tachycardia, fever and injection site reaction a day after receiving the Fluvirin vaccine and PNU-Imme-23 vaccination on 12/05/2000. On 12/06/2000, the patient experienced a tachycardia, and a fever of 99.8 degrees.  He also developed an injection site reaction characterized by swelling and warmth.  His blood pressure was 112/74 mmHg.  The patient recovered. There was insufficient information to determine the reporter's causality assessment.									U	12/05/2000	12/06/2000	1	Blood pressure 112/74 mmHg	UNK	UNK	Trazodone Wellbutrin Hydrochloride Albuterol		No risk factors reported Anaphylactic Shock Urticaria		PJP200100233	1						2	Feeling hot; Injection site reaction; Injection site swelling; Pyrexia; Tachycardia	FLU3~EVANS VACCINES~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~PFIZER\WYETH~~UNK~IM~RA~PNEUMO (PNU-IMUNE)~2	USA		Influenza
0232249	01/14/2005					M	10/10/2002	A literature report was received on 13Jun01, concerning a 70 year old male pt who experienced giant cell arteritis which led to hospitalization immediately after receiving influenza vaccine on an unk date. On an unk date, the pt developed a common cold with headache which he was able to relieve with aspirin. Despite this infection he was vaccinated against influenza 5 days after the onset of symptoms. Immediately after vaccination he developed a newly located severe headache, fever, facial oedema and high blood pressure. Ten days after vaccination, his headache became so severe that he had to be hospitalized. Initially, only chemosis and facial oedema were found. The C-reactive protein level was 29.5 mg/dL (reference value, less than 1 mg/dL). His headache was relieved with opiates, but antibiotics were ineffective. On the third day of hospitalization, he also developed blurred vision, proptosis, pain on eye movements, and weakness of the right upper limb. Magnetic sodium (1000 IU/d) was begun. On the fifth day of hospitalization, the pt developed proptosis and chemosis of the right eye, bilateral ptosis, spontaneous nystagmus, weakness of the right abducens muscle, ad peripheral facial palsy on the right side, and his visual acuity further deteriorated. The C-reactive protein level further increased, and levels of thrombocytes and immunoglobulins were elevated in samples of serum and cerebrospinal fluid. The blood sedimentation rate was 94/92 mm/h. Cerebral angiography on the eleventh day of hospitalization revealed recanalized carvernous sinus thrombosis and tortuous temporal arteries, which, along with the clinical and laboratory findings, led the physician to the suspicion of arteritis temporalis. Giant cell arteritis was confirmed by the temporal artery biopsy findings. Overall 4 of the 5 criteria were fulfilled. Treatment with antibiotics and heparin was discontinued. Corticosteroid therapy was initiated and relieved all the described abnormalities during the following days. The pt's recovery was almost complete. All previous serological abnormalities had normalized. Only slight weakness of the right upper extremity persisted.  The reporter had assessed the relationship of the influenza vaccine to the event as likely. That the common preceding vaccination contributed to the GCA was also stated to be quite likely. The physician stated that it can not be definitely excluded that the influenza-like symptoms at the onset were already the initial manifestation of GCA. The physician stated that the GCA was responsible for most of the abnormal findings although it could not be definitely excluded that facial nerve palsy and plexopathy were due to the initial vial infection before the vaccination. Impaired visual acuity, bilateral ptosis, abducens paresis, proptosis and facial oedema were assumed to have been caused by the carvernous sinus thrombosis.					Y				Y				C-Reactive Protein 26.5mg/dl; ESR 84/92 mm/hr; Sedimentation Rate	UNK	UNK	NONE		NONE		PJP200100179	1						1	Arteritis; Asthenia; Conjunctival oedema; Exophthalmos; Eyelid ptosis; Face oedema; Headache; Hypertension; Laboratory test abnormal; Nystagmus; Paralysis; Pharyngitis; Pyrexia; Rhinitis; Thrombosis; Viral infection; Vision blurred; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0232250	01/14/2005		46.0	45		M	10/10/2002	Report received from a registered pharmacist regarding a possible adverse event associated with the use of Fluvirin. A 49 year old male patient received vaccination with Fluvirin, lot number E67930KA or E67940KA, on 10/10/00. On 12/2/00, this patient developed right parascapular pain and on 12/6/00 developed right hand weakness and dyscoordination. He has specific weakness of thumb and abduction of fingers with decreased pinch and grip strength. A C-Spine MRI was performed and did not explain symptoms. A MRI of his brain is pending. A tentative diagnosis has been made of brachial plexitis. The patient has a history of hypertension and takes lisinopril. No other information was provided. Attempts to obtain further information were attempted with reporter unable to provide any specific information. Follow up received from reporter on 6/27/01 via telephone. The reporter states that she received follow up information consisting of the following: The patient has not recovered and has regained 70% of his strength in his right arm and shoulder and still experiences pain in the right arm and prescapula requiring daily use of Motrin. The patient is seeing a neurologist who confers with Personage Turner Syndrome. No other information was available, further information requested from the reporter. (OMIC)									U	10/10/2000	12/06/2000	57	MRI- C spine MRI did not explain symptoms	UNK	UNK	Lisinopril		Hypertension		MPI200100031	1						1	Coordination abnormal; Hemiparesis; Pain; Radiculitis brachial	FLU3~EVANS VACCINES~E67930KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232252	01/14/2005		83.0	82		F	10/10/2002	Spontaneous report received on 11/16/00 from a medical assistant in a dermatologist's office regarding an adverse event possibly related to administration of Fluvirin. On 10/6/00, this 83 year old female received a Fluvirin injection. Shortly after receiving the injection, she developed a temperature of 102 degrees F, chills, and general malaise. These symptoms lasted approximately four days. In mid-Octiber, she developed lesions on her hands and in her mouth. She was treated with an unspecified course of Prednisone, with symptom abatement. After completion of the Prednisone therapy, the symptoms reappeared. She was then treated with an injection of Kenalog and topical use of Orabase and Kenalog ointments; lesions remain at the time of this report. The diagnosis of Stevens-Johnson Syndrome has been made. The reporter stated that the dermatologist's office has treated this patient for over ten years. She indicates that patient is normally very mentally there, but that the patient hasn't been herself. She describes the patient as being easily confused and forgetful. Patient has a history of hypertension, pharyngitis, hypothyroidism, unidentified gastrointestinal problems, and increased weight loss. Additional information has been requested from the physician. Follow up information from PCP received on 10/11/01: The additional adverse events of sore throat and swollen lips were identified. Patient has resolution of symptoms by November 20, 2000. Dosages and therapy dates of concomitant medications were clarified.									U	10/06/2000				UNK	UNK	Librax; Cozaar; Norvasc; Temazepam; Clidinium; Levothyroxine		Hypertension; Pharyngitis; Hypothyroidism; Gastrointestinal problems; Increased weight loss		MPI200004922	1						1	Chills; Confusional state; Malaise; Memory impairment; Pyrexia; Skin ulcer; Stevens-Johnson syndrome	FLU3~EVANS VACCINES~E67320HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232255	01/14/2005		5.0	4		M	10/10/2002	A report was received from a health care professional on 10/17/01 regarding a 4 year old male patient who experienced severe cellulitis on 10/16/01 after receiving Fluvirin vaccine (batch E05211KA) on 10/15/01. Concomitant medications included Ranitidine hydrochloride, Salbutamol and Cromoglicate sodium. The patient had 2 previous administrations of influenza vaccine in 2000 and 1999 without any adverse reaction. On 10/16//01, the patient's parent reported a severe cellulitis on their son's arm, located below the deltoid and above the elbow, at the site of the injection. The patient was seen by a physician on 10/17/01 when the cellulitis area was determined to be approximately 11.5cm by 12.5cm in size. The event was considered to be medically significant. The physician prescribed oral Cephalexin antibiotic to treat the cellulitis. The event was still ongoing at the time of reporting. The reporter has assessed the relationship of study medication to the event as probable. (OMIC)									N	10/15/2001	10/16/2001	1		UNK	UNK	Zantac (Ranitidine Hydrochloride) several months 1 tsp daily; Albuterol (Salbutamol) 0.5ml prn; Intal (cromoglicate sodium) 1 Ampoule prn		NONE		PJP200100342	1						1	Cellulitis; Injection site reaction	FLU3~EVANS VACCINES~EO5211KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232256	01/14/2005		64.0	63		F	10/10/2002	A report was received from a health professional on 11/1/01 concerning a 63 year old female patient who experienced cellulitis 2 days after receiving the Fluvirin vaccine on 10/30/01. Relevant medical history includes a hysterectomy, osteoarthritis, and hypertension on unknown dates. Co-medication taken by the patient included a topical Estrogen patch and Clindamycin. On 11/1/01, the patient experienced cellulitis of the entire right arm 2 days after receiving the Fluvirin vaccine. The Fluvirin administration was given in the right deltoid muscle. Therapeutic measures taken as a result of this event included Clindamycin and Diphenhydramine. The patient had not recovered at the time of report. The reporter assessed the relationship of the study medication to the event as possible. (OMIC)									U	10/30/2001	11/01/2001	2		UNK	UNK	Estrogen; Clindamycin		Surgery; Osteoarthritis; Hypertension		PJP200100354	1						1	Cellulitis; Injection site reaction	FLU3~EVANS VACCINES~E06741LA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232257	01/14/2005		73.0	72		M	10/10/2002	A report was received from a health professional on 11/1/01 concerning a 72 year old male patient who experienced cellulitis 2 days after receiving the Fluvirin vaccine on 10/30/01. Relevant medical history includes Prostate cancer which started on an unknown date. Co-medications taken by the patient include Lupron and Pepcid. On 11/1/01, the patient experienced cellulitis of the entire right arm 2 days after receiving the Fluvirin vaccine. The Fluvirin administration was given in the right deltoid muscle. Therapeutic measures taken as a result of this event included Clindamycin and Diphenhydramine. The patient had not recovered at time of report. The reporter has assessed the relationship of the study medication to the event as possible. (OMIC)									N	10/30/2001	11/01/2001	2		UNK	UNK	Lubron (Leuprorelin acetate), pepcid (famotidine)		Malignant Neoplasm of Prostate		PJP200100355	1						1	Cellulitis; Injection site reaction	FLU3~EVANS VACCINES~E06741LA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232259	01/14/2005		62.0	61		U	10/10/2002	A report received from a health care professional on 08Nov01 regarding a 61 year old male pt who died on 06Nov01 after receiving Fluvirin vaccine on 05November2001. Relevant medical history included right  CVA(hemiparesis), hypertension and coronary bypass surgery. The pt was taking acetylsalicylic acid, doxazosin mesilate, diltiazem hydrochloride, enalapril maleate, venlafaxine hydrochloride, isosorbide mononitrate, metoprolol tartrate, clopidogrel sulfate, lanscprazole, trazodone, glyceryl trinitrate, parecetamol and ranitidine hydrochloride. The pt was institutionalized in a nursing home and received a Fluvirin injection on 05Nov01. The next evening, the pt complained of chest pain and right hand pain. He was given sublingual nitroglycerin with marginal relief and experienced increasing shortness of breath. Subsequently, the pt was transported to the hospital and was pronounced dead upon arrival on 06Nov01. The reporter stated that the pt may have experienced a massive myocardial infarction. The reporter has assessed the relationship of study medication to the event as unk.	Y	11/06/2001							U	11/05/2001	11/06/2001	1		UNK	UNK	Aspirin, Cardora, Cardizem, Vasotec, Effexor, Imdur, Lopressor, Plavix, Prevacid, Trazadone, Nitroglycerin, Tylenol, Zantac		Acute but ill-defined cerebrovascular disease		PJP200100387	1						1	Chest pain; Dyspnoea; Myocardial infarction; Pain	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0232262	01/14/2005		78.0	77		F	10/10/2002	A report was received from a health professional on 11/27/01 concerning a 77 year old female patient who experienced Bell's Palsy which was considered medically significant (OMIC) 21 days after receiving the Fluvirin vaccine on 10/30/01. The patient received influenza vaccine on 11/3/98 and 11/4/00 without incidence. The patient was diagnosed with breast cancer in 1980, which is currently in remission. For the treatment of this cancer the patient has for years been taking Raloxifene Hydrochloride and Megestrol Acetate orally on a daily basis. The patient has also , for an unspecified period, been taking hydrochlorthiazide orally on a daily basis, for the treatment of hypertension. On 11/20/01, the patient experienced constriction of the mouth and difficulty swallowing. On 11/21/01, the patient was seen by a physician, was diagnosed with Bell's Palsy, and Prednisone was prescribed with some improvement. On 11/27/01, the patient was seen by her regular physician for follow up. The diagnosis of Bell's Palsy was again confirmed as the patient presented with lip drooping, however swallowing had improved. Prednisone for an additional two weeks was prescribed. The reporter was assessed the relationship of Fluvirin to the event as probable.									U	10/30/2001	10/30/2001	0		UNK	UNK	Evista; Megace; Dyazide		Hypertension; Carcinoma In Situ Breast		PJP200100436	1						1	Dysphagia; Facial palsy	FLU3~EVANS VACCINES~E09881LA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232264	01/14/2005		12.0	11		M	10/10/2002	A report was received from a health professional on 12/10/01 concerning an 11 year old male patient who experienced an asthma attack, resulting in hospitalization, the morning after receiving Fluvirin on 11/13/01. The patient has had asthma for an unknown duration and takes unknown concomitant asthma medication orally on an ongoing basis. It is not known whether or not the patient has been previously exposed to Fluvirin. On 11/13/01, the patient received a Fluvirin injection IM on the left deltoid muscle. On the morning of the next day (11/14/01), the patient experienced an asthma attack. He was admitted to hospital for the treatment of the asthma attack on 11/15/01. The reporter provided no information on the inpatient therapy regimen. The patient was discharged from hospital on 11/19/01 and has recovered. The reporter assessed the relationship of study medication to the event as possible, also stating that the event may have been contributed to by the patient's medical history.					Y				Y	11/13/2001	11/14/2001	1		UNK	UNK	Asthma medication		NONE		PJP200100467	1						1	Asthma; Condition aggravated	FLU3~EVANS VACCINES~E06731KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0232265	01/14/2005		59.0	58		F	10/10/2002	A report was received from a health care professional on 12/27/01 concerning a 58 year old female patient who experienced cerebral thrombosis, which led to hospitalization, within 48 hours of receiving Fluvirin on 10/18/01 or 10/19/01. The patient had a hysterectomy in 1998, has been diagnosed for years with osteoarthritis of the right knee, has had menopause diagnosed for years, and was diagnosed within the last year with glaucoma. The patient takes Conjugated Estrogens for menopause, and Fluticasone Propionate and Loratadine for allergy. The patient received a flu vaccine of unknown source on 11/5/99 without incidence. On 10/18/01 or 10/19/01, the patient received a Fluvirin vaccine on her deltoid muscle. Within 48 hours (10/20/01), the patient was diagnosed with a cerebral thrombosis and was admitted to a hospital. The patient experienced cerebral thrombosis, MCA with right hemiparesis, and aneurysm on the left carotid artery. The patient was discharged on 10/29/01 and at the time of the report was undergoing rehabilitation therapy. The reporter has stated that the patient's family doctor believed that there was a probable relationship with Fluvirin. The patient did not have a risk factor for stroke per her family physician.					Y				N	10/18/2001	10/20/2001	2		UNK	UNK	Premarin; Flonase; Claritin;		Menopausal and Post-menopausal disorders; Glaucoma; Osteoarthritis; Surgery; Allergy		PJP200200001	1						1	Cerebral thrombosis; Hemiparesis; Intracranial aneurysm	FLU3~EVANS VACCINES~E06731KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0232268	01/14/2005		51.0			M	10/10/2002	A report was received on 1/2/02 concerning a 51 year old male patient who was hospitalized for chest pain after a visit to the Emergency Room after receiving Fluvirin vaccine on 12/11/01.					Y				U	10/27/1998	12/11/1998	45		UNK	UNK	NONE		NONE		PJP200200008	1						1	Chest pain	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0232270	01/14/2005					F	10/10/2002	A report was received from a health care professional on 10/26/01 regarding a female patient (age not reported) who experienced brachial plexitis on 10/19/01 after receiving Fluvirin vaccine on 10/16/01. Three days after vaccination in the left deltoid muscle, the patient presented with weakness and clumsiness in the left arm extending from the elbow down to the hand, diagnosed as brachial plexitis. No treatment was administered to the patient. According to a neurologist, it is thought that the patient experienced a neurological immune reaction. At the time of reporting, the patient's condition was slowly improving. The reporter has assessed the relationship of study medication to the event as unrelated. the patient has received influenza vaccine in the past years. Following internal review, on 1/21/02, this case was upgraded to serious, and following clarification on 1/25/02, the reporter's causality was amended to possible. (OMIC)									N	10/16/2001	10/19/2001	3		UNK	UNK	Tenormin		Hypertension		PJP200100352	1						1	Clumsiness; Muscular weakness; Nerve injury	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232271	01/14/2005		19.0	18		M	10/10/2002	A report was received from a health professional on 1/30/02 regarding an 18 year old male patient who experienced nodules on legs and bottom of feet after receiving a Fluvirin vaccine on 11/20/01. The patient had a previous flu vaccine in 2000. On 11/20/01 the patient received a Fluvirin vaccine and on 11/27/01 the patient experienced severe pain in both legs and feet, he also started to have painful nodules on legs and bottom of feet. The patient was admitted to hospital where he remained for four days. The patient was treated with Diazepam, Prednisolone and Paracetamol. Hepatitis B and Meningitis vaccines were given approximately 2 weeks after the event. It is not known if the patient had recovered at the time of reporting the event. There was insufficient information to determine the reporter's causality assessment.					Y				U	11/20/2001	11/27/2001	7		UNK	UNK			NONE		PJP200200092	1						1	Pain; Skin nodule	FLU3~EVANS VACCINES~E11931LA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0232275	01/14/2005		75.0	74		M	10/10/2002	Telephone report received on January 23, 2001, regarding adverse events possibly associated with administration of Fluvirin.  A wife reported that her 74 year old husband developed atrial fibrillation and polymyalgia rheumatica approximately 3 weeks after receiving a Fluvirin vaccination at a local VA Clinic.  He was then prescribed Lasix (ferosemide) for his heart, Coumadin (wafarin sodium) for his blood, Prednisone (Prednisolone) for his PMR, and Synthorid (thyroxine sodium) for his thyroid.  He had previously been on no medications and had no medical problems.  He has received flu shots in the past, without problems.  This symptoms manifested as achiness in his hips, thighs, and calves.  He normally works out at a club three times per week, but has not yet been able to resume that activity. Follow up information received April 24th, 2001;  Physician identified as primary care provider wrote:  I did not administer a flu shot to this patient.  No further information is expected. Additional information received on June 5, 2001, from treating Rheumatologist.  The day after receiving the flu vaccine, the patient woke up with severe pain in thighs, calves, and hips.  A few days later, joint pain began.  This patient also had fevers to 102 and lost 22 pounds.  The family doctor started him on Prednisone, Plaquenil, and NSAID's with good effect.  As of 05/21/2001, his positive RF has persisted.  Rheumatologist now believes this patient has chronic sero+ RA.  Hand x-rays to look for pattern of erosion have been taken; results are pending at this time. (OMIC)									U	10/10/2000				UNK	UNK	Concomitant drug not reported.		No risk factors reported. Psoriasis C-Spine Disc Disease		MPI200100047	1						1	Atrial fibrillation; Pain; Polymyalgia rheumatica	FLU3~EVANS VACCINES~59070GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232276	01/14/2005		49.0	48		F	10/10/2002	A report was received from a health professional on 10/10/01 concerning a patient who experienced asthmatic symptoms and felt faint within 5 minutes of receiving Fluvirin. The patient has a history of allergy to latex and cats, but no known allergy to egg products. The patient began to cough and had difficulty breathing within 1 minute of the Fluvirin injection. She was given oral loratadine, but continued to have asthmatic symptoms and then began to feel faint, at which time she was given SC epinephrine hydrochloride. It took close to 24 hours for the symptoms to resolve. No reaction was seen at the site of the injection and there was no indication the vaccine may have entered a blood vessel. There was insufficient information to determine the reporter's causality assessment. Follow up information received on 2/8/02 stated that the patient was a 48 year old who had a previous flu vaccination on 10/6/99. Fluvirin was administered on 10/1/01 IM to the patient's left arm. Asthma-like symptoms developed within 5 minutes and persisted for 2-3 days, then resolved. In addition, the patient was treated with Fexofenadine hydrochloride. The reporter has indicated that he has sent the report to the regulatory authority. Following internal review on 5/7/02, this case was upgraded to serious. (OMIC)									Y	10/01/2001	10/01/2001	0		UNK	UNK	NONE		The pt is not allergic to egg and eats egg dishes with no reaction. Allergy unspecified.(cats and latex)		PJP200100328	1						1	Asthma; Cough; Dizziness; Dyspnoea	FLU3~EVANS VACCINES~E04861KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232277	01/14/2005					F	10/10/2002	A report received from a dispensing manager on 08/20/2001, concerning a female patient of unknown age who experienced whole arm inflammation, after receiving Fluvirin last winter. On an unknown date, the patient experienced whole arm inflammation.  The patient received Fluvirin vaccination last winter and experienced an intense local reaction.									U					UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200100226	1						1	Injection site inflammation	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232279	01/14/2005		63.0			M	10/10/2000	An ASPP (Anonymised Single Patient Print) was received from the  MCS (regulatory authority) on 07/18/2001, concerning a 63 year old male patient who experienced capsulitis of the shoulder after receiving influenza vaccine October 2000.  In November 2000, the patient received the vaccination in the left arm.  The reporter did not consider the reaction to be serious. There was insufficient information to determine the reporter's causality assessment.									U					UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200100235	1						1	Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0232280	01/14/2005		20.0			F	10/10/2000	A report was received from a healthcare professional on 06/16/2001, concerning a 20 year old female patient who experienced motor deficiency on the left foot after receiving the Fluvirin vaccine in November 2000. In November 1999, the patient experienced motor deficiency on the left foot after receiving Vaxigrip influenza vaccine and again in November 2000 after receiving Fluvirin vaccine.  The patient recovered in May 2000 and April 2001 respectively. The reporter assessed the relationship of the Vaxigrip influenza vaccine to the event as unclassifiable. The reporter has assessed the relationship of the Fluvirin vaccine to the event as probable.									U					UNK	UNK	Concomitant drug not reported.		No risk factors reported. Motor problems with limbs.		PJP200100249	1						1	Muscle disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0232281	01/14/2005		14.0			M	10/10/2002	A report was received from a healthcare professional on 04/09/2001, concerning a 14 year old male patient who experienced mid-epigastric pain on 03/01/2001 after receiving the Fluvirin vaccine on the same day. On 03/02/2001, the patient experienced epigastric pain.  The symptoms eventually resolved on an unknown date without further complications. There was insufficient information to determine the causality assessment of the reporter. Cross reference with PJP-2001-00267 and PHP-2001-00271.									U	03/01/2001	03/02/2001	1		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200100270	1						1	Abdominal pain upper	FLUX~UNKNOWN MANUFACTURER~E731001LA~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0232282	01/14/2005					U	10/10/2002	A report was received from a health professional on April 09, 2001 concerning several patients of unknown demography who experienced mild flu-like symptoms, nausea or vomiting, lethargy and mid-epigastric pain after receiving the Fluvirin vaccine on unknown dates. On unknown dates several patients experienced mild flu-like symptoms, nausea or vomiting, lethargy and mid-epigastric pain.  At the time of the report it was unknown if the patients had recovered. There was insufficient information to determine the causality assessment of the reporter.  Cross Reference with PJP2001-00267 and PJP-2001-00270.									U					UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200100271	1						1	Abdominal pain upper; Influenza like illness; Lethargy; Nausea; Vomiting	FLU3~EVANS VACCINES~E73100LA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232283	01/14/2005		35.0			F	10/10/2002	A report was received from a health professional on 9/14/01 concerning a 35 year old female patient who was hospitalized due to anaphylaxis after receiving a Fluvirin vaccine on 9/11/01. The patient is allergic to Sulfa drugs and metoclopramide. The patient received a dose of flu vaccine 1 year previously with no problems. On 9/11/02, the patient experienced anaphylaxis including redness/itching, difficulty breathing and chest pain 10 minutes after receiving a Fluvirin vaccination. Therapeutic measures taken as a result of this event included Diphenhydramine 50mg IV and Epinephrine 1:1000, which were administered IV. The patient then became blue, developed red welts on chest and extreme pallor of extremities, with apnea for about 30 seconds. Oxygen was administered and the patient was admitted to hospital on 9/11/01 with symptoms abating but continuing. The patient recovered on 9/13/01 and was due to be discharged from hospital on 9/14/01. The reporter has assessed the relationship of study medication to the event as possible.					Y	3			Y	09/11/2001	09/11/2001	0		UNK	UNK	NONE		Allergy		PJP200100279	1						1	Anaphylactic reaction; Apnoea; Chest pain; Cyanosis; Dyspnoea; Erythema; Hypoxia; Pallor; Pruritus; Urticaria	FLU3~EVANS VACCINES~E00931HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0232284	01/14/2005		55.0			F	10/10/2002	A report received from a nurse on 10/02/01, concerning a 55 year old female who experienced redness and swelling at the injection site on 09/22/01 after being injected with 0.5 ml of Fluvirin at the right deltoid area on 09/21/01. The patient was treated with Tylenol and her current condition was described as better at the time of reporting. It is unknown whether the patient has received any prior influenza vaccination. The reporter has assessed the relationship of study medication to the event probable. See PJP200100298 and PJP200100299.									U	09/21/2001	09/22/2001	1		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200100295	1						1	Injection site erythema; Injection site swelling	FLU3~EVANS VACCINES~E02751HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232285	01/14/2005		35.0			U	10/10/2002	A report received from a nurse on October 02, 2001, concerning a 35 year old female patient who experienced redness, itching and swelling at the injection site on September 22, 2001 after receiving an IM injection of Fluvirin 0.5ml at the right deltoid area on September 21, 2001. The patient was treated with Tylenol and her current condition was described as better at the time of reporting.  It is unknown whether the patient has received any prior influenza vaccination. The reporter has assessed the relationship of study medication ot the event probable. See PJP-2002-00295 and PJP-2001-00299.									U	09/21/2001	09/21/2001	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200100298	1						1	Erythema; Injection site swelling; Pruritus	FLU3~EVANS VACCINES~E02751HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232286	01/14/2005		67.0			F	10/10/2002	A report was received from a nurse on 10/02/2001, concerning a 67 year old female patient (hl) who experienced redness and swelling at the injection site and flu-like symptoms including fever, malaise and nausea on 09/22/2001 after receiving an IM injection of Fluvirin 0.5ml at the right deltoid area on 09/21/2001. The patient was treated symptomatically with Tylenol and her current condition was described as better at the time of reporting.  It is unknown whether the patient has received any prior influenza vaccination. The reporter has assess the relationship of study medication to the event probable. See PJP-2001-00295 and PJP-2001-00298.									U	09/21/2001	09/22/2001	1		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP-2001-00299	1						1	Influenza like illness; Injection site erythema; Injection site swelling; Malaise; Nausea; Pyrexia	FLU3~EVANS VACCINES~E02751HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232287	01/14/2005					F	10/10/2002	A report received from a pharmacist on October 5, 2001, concerning a female patient who experienced severe reaction which started the previous year (2000), after receiving Fluvirin vaccine. There was insufficient information to determine the reporter's causality assessment. PJP-2001-00306 was deleted when determined to have been entered twice and to be a duplicate of this case.  This case remains the master report.									U					UNK	UNK	Concomitant drug not used.		No risk factors reported.		PJP200100310	1						1	Nonspecific reaction	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232288	01/14/2005		48.0	48		F	10/10/2002	A report was received from a health professional on 10/08/01, concerning a 48 year old female patient who experienced an injection site reaction, almost immediately after receiving the Fluvirin vaccine on 10/08/01. The patient had previously received the Influenza vaccine on Oct. 2000. On 10/05/2001, the patient experienced a red raised rash approximately 4 inches by 3 inches at the site of administration, almost immediately after receiving the Fluvirin vaccine. Initially, it was tender, hot and painful, but these symptoms resolved after one day. The patient had completely recovered on 10/08/01. The reporter has assess the relationship of the study medication to the event as probable.									Y	10/05/2001	10/05/2001	0		UNK	UNK	Mircette (Marvelon) 1 Tab once a day Claritin (Loratadine)		No risk factors reported. Concurrent Disease: Hay fever		PJP200100311	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~EVANS VACCINES~E02111HA, P~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232289	01/14/2005		46.0	46		F	10/10/2002	A report was received from a health care professional on 10/08/01, concerning a 46 year old female healthcare professional who experienced flu like symptoms, approximately 24 hours after she inadvertently administered the Fluvirin to a patient. On 10/03/01, the health care professional experienced flu like symptoms including fatigue and nausea, approximately 24 hours after she, accidentally sprayed her eyes with Fluvirin, during administration. The healthcare professional flushed her eyes with sterile solution immediately after the exposure. She recovered 3 days later on 10/06/01. The reporter has assessed the relationship of study medication to the event as possible.									Y	10/02/2001	10/02/2001	0		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200100319	1						1	Fatigue; Influenza like illness; Medication error; Nausea	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232290	01/14/2005		62.0	62		M	10/10/2002	A report was received from a health professional on 10/10/01, concerning a 64 year old male patient who experienced chest pains, dizziness and headache immediately after receiving Fluvirin vaccine on 10/05/98. The events resolved 24 hours later. There was insufficient information to determine the reporter's causality assessment.									Y	10/05/1998	10/05/1998	0		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200100329	1						1	Chest pain; Dizziness; Headache	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232291	01/14/2005		49.0	49		M	10/10/2002	A report was received from a consumer on 10/11/01 and a follow up from a health professional on 12/14/01, concerning a 49 year old male who experienced flu like symptoms and an injection site reaction, approximately 3 weeks after receiving the Fluvirin vaccine on 10/23/00. In November 2000, the patient experienced flu like symptoms and an inability move his arm for a few days, approximately 3 weeks after he received the Fluvirin vaccine on 10/23/00. The patient had recovered at time of the report. There was insufficient information to determine the reporter's causality assessment. A follow up report was received on 12/14/01 which changed the reporter's causality assessment to probable.									Y	10/23/2000				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200100335	1						1	Hypokinesia; Influenza like illness	FLU3~EVANS VACCINES~P28~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232292	01/14/2005					F	10/10/2002	A report was received from a health care professional on 10/24/01 regarding a 71 year old female patient who experienced rash on arms and chest few days after receiving Fluvirin vaccine on 10/16/01. The event was reported to be resolved. There was insufficient information to determine the reporter's causality assessment.									Y	10/16/2001				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200100336	1						1	Rash	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232293	01/14/2005		53.0	53		F	10/10/2002	A report was received from a health professional on 10/12/01, concerning a 53 year old female patient who experienced an injection site reaction after receiving Fluvirin vaccine on 10/04/01. The patient had previously received an Influenza vaccination on 11/18/99 (Batch number 60065AA). The patient received 0.5 mg IM, in the left arm on 10/04/01. The patient developed erythema with a central yellowish clearing. There was not pain or tenderness and no warmth or sign of infection. The patient was treated with warm compresses and Benadryl every 4 to 6 hours. The arm was rechecked on 10/11/01 and the skin tone was normal and the arm was getting better. At the time of the report, the patient was rescheduled in 1 week. There was insufficient information to determine the reporter's causality assessment.				Y					U	10/04/2001	10/04/2001	0		UNK	UNK	Concomitant Drug Not reported		No risk factors reported.		PJP200100345	1						1	Injection site erythema	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0232294	01/14/2005		88.0	88		F	10/10/2002	A report was received from a health professional on 10/15/01 concerning an 88 year old female patient who received a Fluvirin overdose on 10/15/01 after an initial dose of 10/08/01. The patient experienced a sore arm after the second vaccination which resolved without sequelae on 10/16/01. There was insufficient information to determine the reporters causality assessment.									Y	10/15/2001	10/15/2001	0		UNK	UNK	Vitamin B12 (Cyanocobalamin) 05/04/95 1000mg, Timoptol (Timolol Maleate) 10/1/01, Latanoprost 07/19/99, Aspirin (Acetylsalicylic Acid)		No risk factors reported.		PJP200100346	1						1	Accidental overdose; Medication error; Pain	FLU3~EVANS VACCINES~760171~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232295	01/14/2005					U	10/10/2002	A report was received from a health professional on 10/12/01 concerning a patient of unknown demography who had received an overdose of Fluvirin on 10/12/01. On 10/12/01the patient was have a number of vaccinations and was inadvertently given 2 doses of Fluvirin within a time frame of a few minutes. There were no Adverse Events reported at the time of reporting.									U					UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200100347	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232296	01/14/2005		73.0			F	10/10/2002	A report was received from a health care professional on 10/26/01 regarding a 80 year old female patient who developed a rash 24 hours following the administration of Fluvirin vaccine (batch E4254BB) on 12/01/94. Rash was described as red, pitted, lumpy over arm and chest. The patient was treated with cortisone cream administered by the casualty department. The event resolved approximately 6 days later. There was insufficient information to determine the  reporter's causality assessment.									U	12/01/1994	12/02/1994	1		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200100349	1						1	Rash maculo-papular	FLU3~EVANS VACCINES~E4254BB~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232297	01/14/2005		50.0			F	10/10/2002	A report was received from a health professional on 10/17/01, concerning a 70 year old female patient who experienced mild flu like symptoms and a hot and red arm, 1 hour after receiving the Fluvirin vaccine on 10/10/01. The patient experienced a similar reaction last year but it is unknown if it was due to Fluvirin. The patient recovered on 10/16/01. There was insufficient information to determine the causality assessment of the reporter.									Y	10/01/2001	10/01/2001	0		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200100350	1						1	Erythema; Feeling hot; Influenza like illness	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232298	01/14/2005		42.0			F	10/10/2002	A report was received from a health care professional on 16 October 2001 regarding a 42 year old female patient who experienced an injection site reaction on 12 October 2001 after receiving fluvirin vaccine (batch E04861KA) on 11 October 2001. The patient received the flu vaccine the year before without a problem. Twenty four hours following the vaccination, the patient developed a 5-10 mm wheal and peripheral blisters. No treatment was undertaken and the wheal and blisters resolved on their own 3 days later. There was insufficient information to determine the reporter's causality assessment.									U	10/11/2001	10/12/2001	1		UNK	UNK					PJP200100351	1						1	Blister; Urticaria	FLU3~EVANS VACCINES~E04861KA~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232299	01/14/2005		76.0	76		M	10/10/2002	A report was received from a health professional on 10/18/2001, concerning a 76 year old male patient who experienced an overdose, after inadvertently receiving the Fluvirin vaccine on 10/08/2001 and again on 10/18/2001. On 10/18/2001, the patient experienced an overdose after inadvertently receiving a second Fluvirin vaccination 10 days after the first vaccination. No adverse effects were reported at time of report. No other information was available. There was insufficient information to determine the causality assessment of the reporter.									U	10/08/2001	10/18/2001	10		UNK	UNK					PJP200100353	1						1	Accidental overdose	FLU3~EVANS VACCINES~~3~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232300	01/14/2005					U	10/10/2002	A report was received from a health professional on 10/09/2001 concerning a patient who was inadvertently given last season's Fluvirin vaccine. There was no adverse event reported. There was insufficient information to determine the reporter's causality assessment.									U					UNK	UNK					PJP200100358	1						1	Incorrect dose administered	FLU3~EVANS VACCINES~~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232302	01/14/2005					U	10/10/2002	A report was received from a distributor on 10/12/2001, concerning 2 elderly patients who experienced an overdose, after inadvertently receiving 2 doses of the Fluvirin vaccine 2 days apart, on an unknown date. On an unknown date, 2 elderly patients experienced an overdose after inadvertently receiving 2 doses of the Fluvirin vaccine 2 days apart. No adverse effects were reported at time of report. No other information was available. There was insufficient information to determine the causality assessment of the reporter.									U	10/08/2001	10/08/2001	0		UNK	UNK					PJP200100362	1						1	Accidental overdose	FLU3~EVANS VACCINES~~3~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232303	01/14/2005		74.0			M	10/10/2002	A report was received from a health professional on 10/17/2001 concerning a 74 year old male who experienced an overdose of Fluvirin on 10/17/2001. The patient received a Fluvirin vaccination on 10/12/2001, then again on 10/17/2001 in error. There were no adverse events reported at the time of reporting. There was insufficient information to determine the reporter's causality assessment.									U	10/12/2001	10/17/2001	5		UNK	UNK					PJP200100363	1						1	Accidental overdose	FLU3~EVANS VACCINES~~3~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232304	01/14/2005		65.0			M	10/10/2002	A report was received from a consumer's wife on October 19, 2001 regarding an elderly male patient who experienced syncope and swollen and inflamed joints after receiving Inactivated Influenza vaccine in 1986 and 1987. The patient was vaccinated in 1986 and experienced syncope and collapsed approximately 48 hours later.  The patient was vaccinated in 1987 after which he experienced swollen and inflamed joints which lasted 5 weeks.  The patient has recovered from both incidents.									U					UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200100364	1						1	Swelling; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0232305	01/14/2005		53.0	53		F	10/10/2002	A report was received from a health professional on 10/30/01 concerning a 53 year old female patient who experienced swelling of the elbow and wrist and subsequently experienced swelling of the knee, 3 and 6 days respectively after receiving the Fluvirin vaccine on 10/17/01. On 10/20/01, the patient experienced swelling of the left elbow and wrist 3 days after receiving the Fluvirin vaccine in the left deltoid muscle. The swelling spread to the hands whereby the patient was unable to put her ring on. On 10/23/01, the patient noticed swelling and pain in the right knee and had difficulty sleeping, going up and down stairs and putting pants on as a result of the swelling in the knee. The patient tested negative for gout, lupus and rheumatoid arthritis. At the time of report, the patient was still recovering. The reporter has assessed the relationship of the study medication to the event as possible. (OMIC)									U	10/17/2001	10/20/2001	3		UNK	UNK	NONE		Hypertension		PJP200100366	1						1	Arthralgia; Gout; Insomnia; Joint swelling; Oedema peripheral; Rheumatoid arthritis; Swelling; Systemic lupus erythematosus	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232306	01/14/2005		40.0			M	10/10/2002	A report was received from a health professional on October 22, 2001 concerning a 40 year old male patient who experienced lethargy and headache after receiving Fluvirin in October 2000. 20 minutes after the vaccination the patient complained of a tight ring around head and having a cotton wool head.  The patient had also been feeling lethargic and listless, especially after exercise.  The patient had not recovered at the time of reporting. There was insufficient information to assess the reporter's causality.									U					UNK	UNK	Concomitant drug not reported.		No risk factors reported. Diabetes Mellitus		PJP200100367	1						1	Headache; Lethargy; Listless	FLU3~EVANS VACCINES~757072~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232307	01/14/2005		78.0			M	10/10/2002	A report was received from a health professional on 30 October 2001, concerning a 78 year old male patient who experienced chills, a light head, dilated pupils, raised blood pressure and raised pulse, 45 minutes after receiving an Influenza vaccine on 17 October 2001. On 17 October 2001, the patient experienced a cold clamy feeling, a distant feeling, a lump in throat, dilated pupils, and a raised blood pressure and pulse, 45 minutes after receiving an Influenza vaccine.  The patient recovered 2 hours later. There was insufficient information to determine the reporter's causality assessment.									U					UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200100368	1						1	Blood pressure increased; Chills; Cold sweat; Dizziness; Mydriasis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0232308	01/14/2005		89.0	89		F	10/10/2002	A report was received from a health professional on 22Oct01 concerning an 89 year old female pt who experienced an overdose after receiving a second dose of Fluvirin on 15Oct01. The pt received Fluvirin on 28Sept01 and received a second dose on 15Oct01. There were no adverse events reported. There was insufficient information to determine the reporter's causality assessment.									U	09/28/2001				UNK	UNK	Lansoprazole 30mg 1 in 1 d; Paroxetine 20mg 1 in 1 d; Paracetamol 2 tabs oral; Fe Sulphate (Ferrous Sulfate) 600mg (200mg TID) oral.		NONE		PJP200100369	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~760409~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232309	01/14/2005		52.0	51		F	10/10/2002	A report was received from a health professional on 10/29/02 and a follow up on 04/02/02. A second follow up was received on 05/21/02 concerning a 51 year old female patient, who experienced flu like symptoms the evening following a Fluvirin vaccine on 10/24/01. The patient had been vaccinated in the pas with no side effects. The hospital where she received the vaccine did not refrigerate the vaccine as recommended in the SPC, but stored it at room temperature instead. The patient recovered approximately a week after receiving the vaccination. There was insufficient information to determine the reporter's causality assessment.									U	10/24/2001	10/24/2001	0		PVT	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200100370	1						1	Influenza like illness	FLU3~EVANS VACCINES~760749~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232310	01/14/2005		73.0	72		F	10/10/2002	A report was received from a health care professional on 10/30/2001 and a follow up was received on 11/26/2001, concerning a 73 year old female patient who experienced an overdose, after inadvertently receiving 2 doses of the Fluvirin vaccine 11 days apart, on 10/19/2001 and 10/30/2001. On 10/30/2001, the patient experienced an overdose after inadvertently receiving a second Fluvirin vaccination 11 days after the first vaccination on 10/19/2001. No adverse effects were reported at time of report. There was insufficient information to determine the causality assessment of the reporter.									U	10/19/2001	10/30/2001	11		UNK	UNK	Hydroxocobalamin , Sinemet				PJP200100372	1						1	Accidental overdose	FLU3~EVANS VACCINES~760524~3~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232311	01/14/2005		80.0			F	10/10/2002	A report was received from a health professional on 10/30/2001, concerning an 80 year old female patient experienced an overdose, after inadvertently receiving 2 doses of the Fluvirin vaccine 19 days apart. On 10/30/2001, the patient experienced an overdose after inadvertently receiving a second Fluvirin vaccination 19 days after the first vaccination on 10/11/2001. No adverse effects were reported at time of report. No other information was available. There was insufficient information to determine the causality assessment  of the reporter.									U	10/11/2001	10/30/2001	19		UNK	UNK					PJP200100373	1						1	Accidental overdose	FLU3~EVANS VACCINES~~3~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232312	01/14/2005					F	10/10/2002	A report was received from a health professional on 10/31/2001, concerning a female patient of unknown demography who was inadvertently administered the Fluvirin vaccine whi1st 23 weeks pregnant, on an unknown date. On unknown date, the patient received the Fluvirin vaccine whi1st 23 weeks pregnant. No further information was given. There was insufficient information to determine the reporter's causality assessment.									U					UNK	UNK					PJP200100374	1						1	Unevaluable event	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232313	01/14/2005		55.0			F	10/10/2002	A report was recieved from a health professional on 11/02/2001, concerning a 55 year old female patient who developed an intolerance to eggs, after receiving the Fluvirin vaccine on an unknown date in 1999 and 2000. On an unknown date in 1999, the patient developed an intolerance to eggs, after receiving the Fluvirin vaccine. The patient experienced a similar reaction after receiving the Fluvirin on an unknown date in 2000. At the time of report, the patient had not recovered. There was insufficient information to determine the reporter's causality assessment.									N					UNK	UNK					PJP200100376	1						1	Hypersensitivity	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232314	01/14/2005		29.0			F	10/10/2002	A report was received from a health professional on 11/02/2001, concerning a 29 year old female patient who experienced a headache and blurred vision, 1 day after receiving a Fluvirin vaccine on 10/21/2001. On 11/01/2001 , the patient experienced a temporal headache on the right side and blurring of vision in the left eye, 1 day after receiving a Fluvirin vaccine. The patient had previous vaccinations without adverse reactions. At the time of report, the patient had not recovered. There was insufficient information to determine the reporter's causality assessment.									N	10/21/2001	10/22/2001	1		UNK	UNK					PJP200100381	1						1	Headache; Vision blurred	FLU3~EVANS VACCINES~760167~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232315	01/14/2005		62.0			U	11/03/2001	A report was received from a health professional on 05 Nov 2001, concerning a 62-year-old female patient who experienced swollen and tender lymph nodes, 1 day after receiving the Fluvirin vaccine on 02 Nov 2001.  On 03 Nov 2001, the patient ( a registered nurse and an infection control practitioner ) experienced swollen lymph nodes and tenderness under the right arm that spread to the right chest area, 1 day after receiving the Fluvirin vaccine in the right deltoid muscle.  The patient experienced a similar reaction 2 years previously, following an Influenza vaccination (brand unknown).  At time of report, the patient had not recovered.  There was insufficient informaton to determine the reporter's causality assessment.									U					UNK	UNK	NEED FOR PROPHYLACTIC VACCINATION AGAINST INFLUENZA	11/02/2001 - 11/02/2001	THERAPY DURATION		PJP200100386	1						1	Swelling; Tenderness	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232316	01/14/2005					U		A report was received from a health professional on 03 Apr 2001, concerning 5 patients of unknown demography, who received an overdose of Fluvirin vaccine or Pru-immune-23, on an unknown date.  On an unknown date, the patient inadvertently received a double dose of the Fluvirin vaccine and Pru-immune-23.  No adverse event was reported.  There was insufficient information to determine the reporter's, causality assesment.									U					UNK	UNK	NEED FOR PROPHYLACTIC VACCINATION AGAINST INFLUENZA				PJP200100389	1						1	Accidental overdose	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232317	01/14/2005					U		A report was received from a health professional on 29 October 2001 regarding a female patient over 65 year old who experienced an injection site reaction after receiving Fluvirin vaccine in 2000.  The patient had previsously received Fluvirin with no ill effects.  The patien developped 4 cm area of red swelling around the site of injections.  The event was reported to be resolved.  There was insufficient information to determine the reporter's causality assessment.									U					UNK	UNK	NEED FOR PROPHLACTIC VACCINATION AGAINST INFLUENZA				pjp200100390	1						1	Injection site erythema; Injection site swelling	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232318	01/14/2005					U		A report was received from a Health professional regarding a patient who was accidently given last years flu vaccine in error.  There were no adverse events reported.  There was insufficient information to determine the reporter's causality assessment.									U					UNK	UNK					PJP200100391	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232319	01/14/2005					U	10/10/2002	A report was received from a health professional regarding 20 patients who had inadvertently received only half doses of Fluvirin. There were no adverse events reported. There was insufficient information to determine the reporter's causality assessment.									U					UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200100392	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232322	01/14/2005		0.82	0	.8	F	10/10/2002	A report was received from a healthcare professional on 13Nov01 regarding a 1 month old girl who accidentally received Fluvirin 0.5ml instead of hep B. There were no adverse events reported. No specific treatment other than supportive care was provided. There was insufficient information to determine the reporters causality assessment.									U	11/08/2001	11/08/2001	0		UNK	UNK	NONE		NONE		PJP200100399	1						1	Medication error	FLU3~EVANS VACCINES~E04841KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232326	01/14/2005		6.0	6		M	10/10/2002	A report was received from a health professional on 16Nov01, concerning a 6 year old male pt who experienced an injection site reaction which was considered to be serious as medical intervention was required, several hours after receiving the Fluvirin vaccine on 15Nov01. Relevant medical history include eczema, and seasonal  and food allergies. The pt was received concomitant medication Montelukast sodium for over 6 months. On 15Nov01, the pt developed a local erythematous, edematous, itchy and red reaction at the injection site (approx 13cm by 13cm in area), several hours after receiving the Fluvirin vaccine. Therapeutic measures taken as a result of this event included oral Cetirizine Hydrochloride, oral Prednisolone and topical Corticosteroids. The pt experienced a similar reaction last year after receiving the influenza vaccine (brand unk). At time of report, the pt had not recovered. The reporter has assessed the relationship of the study medication to the event as probable. A follow up report was received on 13Dec01: The reporter described the events as oedema, erythema and pruritus from which the pt recovered on 16Nov01. The pt had experienced a similar reaction last year on 01Nov00. The pt additionally had a medical history of RAD and insect bites. He also was taking budenoside and salbutamol as concomitant medication. The events were not considered to be serious as per telephone conversation 17Dec01.									U	11/15/2001	11/15/2001	0		UNK	UNK	Singulair (montelukast sodium) 07Oct00 5mg, Pulmicort (budesonide) prn, Salbutamol prn		Contact Dermatitis and other eczema, personal history of allergy, other than to medicinal agents, chronic airways obstruction, not elsewhere classified		PJP200100407	1						1	Injection site erythema; Injection site oedema; Pruritus; Vaccine positive rechallenge	FLU3~EVANS VACCINES~E00941HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232327	01/14/2005		33.0	32		F	10/10/2002	A report was received from a health professional on 07Nov01, concerning a 32 year old female pt, who was administered the Fluvirin vaccine on 06Nov01 whilst 7 weeks pregnant. The pt experienced nausea and dizziness in the evening on 06Nov01. The pt had a pregnancy test 2 weeks previously which tested positive. Per the pt, her obstetrician said she was 7 weeks pregnant. The pt experienced nausea and dizziness in the evening of 06Nov01. At the time of the report the pt had recovered. There was insufficient information to determine the reporter's causality assessment.									U	11/06/2001	11/06/2001	0		UNK	UNK	Iron tablets 11Jan01 Daily		Pregnant  (Sex: Female)		PJP200100409	1						1	Dizziness; Nausea; Unintended pregnancy	FLU3~EVANS VACCINES~E04811KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232329	01/14/2005					U	10/10/2002	A report was received from a health professional on 08Nov01, concerning a 48 year old female pt who experienced muscle spasms and wrist pain, 1 day after receiving the Fluvirin vaccine on 25Oct01. On 25Oct01, the pt experienced muscle spasms bilaterally in the arms and legs and wrist pain, 1 day receiving the Fluvirin vaccine. The pt was not treated at the time of event. At time of report, the symptoms had decreased but the pt had not recovered. The reporter has assessed the relationship of the study medication to the event as not known.									U	10/25/2001	10/26/2001	1		UNK	UNK	Questran (Colestyramine), Prilosec (omeprazole)		Other and unspecified environmental and accidental causes, personal history of allergy to antibiotic agent, not  penicillin, personal history of allergy to analgesic agent		PJP200100411	1						1	Arthralgia; Muscle spasms	FLU3~EVANS VACCINES~E04861KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232330	01/14/2005		21.0			F	10/10/2002	A report was received from a health professional on 12Nov01 concerning a 21 year old female pt who experienced cyanosis of the left hand fingers 3,4 and 5 after receiving Fluvirin (batch E02101HA) on 09Nov01. The pt left hand fingers (3,4 and 5) turned blue and were cool touch. She was able to detect sensation. The event was increasing and decreasing in intensity and was ongoing at the time of reporting. There was insufficient information to determine the reporter's causality assessment.									U	11/09/2001				UNK	UNK	NONE		NONE		PJP200100414	1						1	Cyanosis; Peripheral coldness	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232332	01/14/2005		5.0			F	10/10/2002	A report was received from a health professional on 12Nov01 concerning a 5 year old female pt who experienced an injection site reaction 2 days after receiving Fluvirin on 25Oct01. The pt had previously received an influenza vaccine (brand unspecified) in Nov 2000 without any adverse sequelae. The pt is a near drowning victim who is now medically compromised receiving 29 medications on an as needed basis (list unavailable by the reporter at the time of the call). On 25Oct the pt received Fluvirin 0.5ml IM. the pt did not received any concomitant vaccines. After 48 hours, a 5x9cm reddened are with 15-20 white dots developed at the site of injection. Twenty four hours later, the area developed into 2 dime-sized blisters. The physician diagnosed the reaction as a chemical burn. The pt is currently being treated with silver sulfadiazine and oral cephalin. The reporter assessed the relationship to the injection site reaction as probable.									U	10/25/2001	10/27/2001	2		UNK	UNK	NONE		NONE		PJP200100416	1						1	Blister; Injection site erythema; Thermal burn	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232333	01/14/2005					F	10/10/2002	A report was received from a health professional on 19Nov01, concerning a female pt who experienced total body hives, 7 days after receiving the Fluvirin vaccine on 09Nov01. Comedication taken by the pt included a Nicotine patch and Bupropion hydrochloride. On 16Nov01, the pt developed total body hives, 7 days after receiving the Fluvirin vaccine. Therapeutic measures taken as a result of this event included oral Prednisolone and Loratadine. The pt had previous influenza vaccinations (brand unspecified) with no adverse effects. The pt had not recovered at time of report. The reporter has assessed the relationship of the study medication to the event as possible.									U	11/09/2001	11/16/2001	7		UNK	UNK	Nicotine patch 04Nov01-10Nov01, Zyban (Amfebutamone hydrochloride Nov01-10Nov01		NONE		PJP200100417	1						1	Urticaria	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232334	01/14/2005		59.0	58		F	10/10/2002	A report was received from a health professional on 20Nov01, concerning a 58 year old female pt who experienced a maculopapular rash, 1 day after receiving the Fluvirin vaccine on 16Nov01. On 17Nov01, the pt developed a maculopapular rash and pruritus on her abdomen, 1 day after receiving the Fluvirin vaccine. On 20Nov01, the pt was seen at the reporter's clinic for treatment of the rash, which had expanded from the abdomen to the breast and pubic area. The pt did not have a fever or any signs or symptoms of infection. The pt received previous influenza vaccinations in 1999 (Flushield brand), 1998, and 1997 without incident. At the time of report, the pt had not recovered. The reporter has assessed the relationship of the study medication to the event as unclassifiable.									U	11/16/2001	11/17/2001	1		UNK	UNK	NONE		NONE		PJP200100418	1						1	Rash maculo-papular; Rash pruritic	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232342	01/14/2005		50.0			M	10/10/2002	A report was received from a health professional on 11/16/2001 concerning a 50 year old male patient who experienced persistent lightheadedness 5 days after receiving Fluvirin on 11/07/2001. On 11/12/2001 the patient developed lightheadedness that had persisted since onset. The patient did not have a fever or exhibit any flu-like symptoms. The patient's blood pressure and pulse were normal and a neurological exam was normal. The patient was not receiving treatment for lightheadedness at the time of the report. The reporter's causality assessment was recorded as possible.									U	11/07/2001	11/12/2001	5		UNK	UNK	Acetylsalicylic acid, Vitamins				PJP200100435	1						1	Dizziness	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232343	01/14/2005		69.0			M	10/10/2002	A report was received from a health professional on 11/13/2001, concerning a 69 year old male, who experienced an injection site reaction, 3 - 4 days after receiving the Fluviron vaccine on 11/06/2001. On 11/09/2001, the patient experienced severe pain at the injection site, approximately 3 - 4 days after receiving the Fluvirin vaccine in the deltoid portion of his left arm. There were no signs of infection of inflammation including redness and tenderness at the injection site. The patient had received previous influenza vaccinations (brand unspecified) without incidence. The patient did not receive any treatment for the pain. At time of report, the pain had continued for 3 days but was improving. The reporter has assessed the relationship of the study medication to the event as probable.									N	11/06/2001	11/09/2001	3		UNK	UNK	Lipitor				PJP200100438	1						1	Injection site pain	FLU3~EVANS VACCINES~~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232344	01/14/2005		4.0			U	10/10/2002	An anonymous single patient print was received from the MCA on 11/26/01, regarding a 4 year old male patient who experienced wheeze, stridor and loss of voice on 10/16/01 after receiving Fluvirin vaccine (batch 760169) on the same day. The patient's medical history included asthma and the patient was receiving Prednisolone, ipratropium and budesonide. The events resolved on the same day. Therapeutic measures included dexamethasone po and salbutamol nebulizer. There was insufficient information to determine the reporter's causality assessment.									U	10/16/2001	10/16/2001	0		UNK	UNK	Prednisolone, Pulmicort, Atrovent		No risk factors reported		PJP200100440	1						1	Dysphonia; Stridor; Wheezing	FLU3~EVANS VACCINES~760169~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232345	01/14/2005		18.0	18		F	10/10/2002	A report was received from a health professional on 11/20/2001, concerning an 18 year old female patient who experienced fever 38.5 C and pronounced asthenia, 3 days after receiving Fluvirin on 11/11/01. The patient recovered after treatment on 11/15/01. the reporter has assessed the relationship of the study medication to the event as possible.									Y	11/11/2001	11/14/2001	3		UNK	UNK	Concomitant Drug Not reported		No risk factors reported.		PJP20010442	1						1	Asthenia; Pyrexia	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232346	01/14/2005		65.0			M	10/10/2002	A report was received from a health professional on 11/23/01, concerning a 65 year old male patient who experienced an urticarial rash, swollen lips and swollen eyes, 1 day after receiving the Fluvirin vaccine on 11/13/01. The patient had no record of previous vaccination. At the time of report, the patient had recovered. There was insufficient information to determine the reporter's causality assessment.									Y	11/13/2001	11/14/2001	1		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200100443	1						1	Eye swelling; Swelling face; Urticaria	FLU3~EVANS VACCINES~P~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232347	01/14/2005		28.0	28		F	10/10/2002	A report was received from a health professional on 11/26/01, concerning a female patient of unknown demography, who experienced dizziness and malaise 30 to 40 minutes after receiving an influenza vaccine on 11/26/01. The patient recovered without any treatment on 11/26/01, 2 to 3 hours after receiving Fluvirin. The patient had never previously received an influenza vaccine. There was insufficient information to determine the reporter's causality assessment.									U	11/26/2001	11/26/2001	0		UNK	UNK	Concomitant Drug Not Reported.		No risk factors reported.		PJP200100444	1						1	Dizziness; Malaise	FLU3~EVANS VACCINES~760178~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232348	01/14/2005		44.0			F	10/10/2002	An ASPP was received from the MCA on 11/26/2001, concerning a 44 year old female patient who experienced left elbow monoarthritis within 48 hours of receiving Fluvirin  on 10/22/2001. The patient had received an influenza vaccine previously (brand unspecified), and had experienced a mild flu-like illness. On 10/24/2001 the patient was diagnosed with left elbow monoarthritis. There was insufficient information to determine the reporters causality assessment.									U	10/22/2001	10/24/2001	2		UNK	UNK					PJP200100445	1						1	Influenza like illness; Monarthritis	FLU3~EVANS VACCINES~760169~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232349	01/14/2005		44.0			F	10/10/2002	A report was received from a health professional on 11/19/2001 regarding a 44 year old female patient who was inadvertently given last year's Fluvirin vaccine on an unknown date. There was no adverse event reported. There was insufficient information to determine the reporter's causality assessment.									U					UNK	UNK					PJP200100446	1						1	Incorrect dose administered; Medication error	FLU3~EVANS VACCINES~~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232350	01/14/2005		40.0			F	10/10/2002	A report was received from a health professional on 11/20/2001 regarding a 40 year old female patient who was inadvertently given last year's Fluvirin vaccine on 11/20/2001. There was no adverse event reported. There was insufficient information to determine the reporter's causality assessment.									U	11/20/2001	11/20/2001	0		UNK	UNK					PJP200100447	1						1	Incorrect dose administered; Medication error	FLU3~EVANS VACCINES~757377~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232351	01/14/2005					U		A report was received from a health professional on 22 November 2001 regarding a patient (demography not reported) who was inadvertently given expired Fluvirin vaccine (expired in June 2001) on 16 November 2001.  There was no adverse event reported.  There was insufficient information to determine the reporter's causality assessment.									U					UNK	UNK					PJP200100448	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232353	01/14/2005		76.0			F	11/28/2001	A report was received from a health professional on 29 November 2001 regarding a 76 year old female patient who experienced systemic rash on 28 November 2001 after receiving fluvirin vaccine on 27 November 2001.  On 28 November 2001, the patient developed a rash approximately 24 hours after vaccination.  It was raised, pruritic and located on the trunk, scalp and face.  The patient was treated with Atarax.  The patient had a history of coronary artery disease, hypertension, osteoporosis and hyperlipidemia.  At the, time of reporting the patient had recovered.   The reporter has assessed the relationship of the study medication to the event as probable.									U					UNK	UNK					PJP200100455	1						1	Rash	FLU3~EVANS VACCINES~E10811LA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232355	01/14/2005		34.0			U	12/08/2000	A report was received from a patient on 30 November 2001.  The patient, a 34 year old female, experienced an allergic reaction 45 minutes after receiving Fluvirin batch # E73110LA, E72410LA or E71810LA, on 08 December 2001.  On 08 December 2001, (forty-five minutes after the influenza vaccine was administered), the patient experienced shortness of breath, increased heart rate, dizziness, hand and facial tingling, and urination every 10-15 minutes.  The patient was seen in emergency services that day, was diagnosed, with having an allergic reaction to the influenza vaccine, and was prescribed a medication (unknown) for relaxation.  The patient subsequently underwent extensive pulmonary, cardiac, and blood tests through her primary care physician, which were within normal ranges.  At the time of report the patient continued to experience some dizziness and tightness of the chest.  The patient was referred to an allergist about one month prior to report (approximately 1 November 2001) for allergy testing.									U					UNK	UNK					PJP200100463	1						1	Chest discomfort; Dizziness; Hypersensitivity	FLU3~EVANS VACCINES~E73110LA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232356	01/14/2005		97.0			M	11/20/2001	A report was received from a health professional on 30 November 2001 regarding a 97 year old male patient who had received Begrivac on 12 October 2001, and Fluvirin on 20 November 2001.  The reporter stated that while the patient experienced Parkinsonian symptoms beginning in December 2001 this was unrelated to the vaccines and the patient seemed to have suffered no ill effects from having two influenza vaccines.  At the time of reporting the patient had not recovered.  There was insufficient information to determine the reporter's causality assessment.									U					UNK	UNK					PJP200100465	1						1	Medication error	FLU3~EVANS VACCINES~760846~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232357	01/14/2005		71.0			U	10/10/2001	An Anonymised Single Patient Print was received from the MCA on 26 November 2001 regarding a 71 year old female patient who experienced amnesia and blurred vision on 10 October 2001 after receiving fluvirin vaccine on the same day.  On 10 October 2001, the patient had blurred vision and temporary amnesia lasting approximately 2 hours.  The patient recovered and the reported did not consider the events to be serious.  There was insufficient information to determine the reporter's causality assessment.									U					UNK	UNK					PJP200100469	1						1	Amnesia; Vision blurred	FLU3~EVANS VACCINES~~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232360	01/14/2005		79.0	79		U		A report was received from a health professional on 11Dec01 regarding a 78 year old female pt who experienced urinary tract infection (14Nov01), pneumonia (23Nov01), sepsis (unk date) and subsequently died on 06Dec01 after receiving Fluvirin vaccine on 12Nov01. The pt's medical history included Non insulin diabetes mellitus, hypertension, chronic obstructive pulmonary disease, bipolar disorder, glaucoma, anxiety and right hip replacement. The pt was also receiving brimonidine, tartrate, alprazolam, artificial tears, ascorbic acid, clavulin, amphebutamone hydrochloride, docusate sodium, famotidine, ferrous sulfate, furosemide, levothyroxine sodium, rofecoxib, sertraline hydrochloride, olanzapine, cetirizine hydrochloride, paracetamol and insulin. On 12Nov01, the pt received Fluvirin vaccine. Two days later, the pt was hospitalized for urinary tract infection, which resolved on 19Nov01. Then the pt was admitted to hospital for pneumonia on 23Nov01 and discharged on 28Nov01. On 06Dec01, the pt was re-admitted to hospital for an unk reason and died secondary to sepsis on the same day. No death certificate was available. The pt had received a flu vaccine last year without any problem. The reporter has assessed the relationship of study medication to the events as unrelated.	Y	12/06/2001			Y				U	11/12/2001	11/14/2001	2		UNK	UNK	brimonidine, tartrate, alprazolam, artificial tears, ascorbic acid, clavulin, amphebutamone hydrochloride, docusate sodium, famotidine, ferrous sulfate, furosemide, levothyroxine sodium, rofecoxib, sertraline hydrochloride, olanzapine, ceti		Diabetes Mellitus		PJP200100473	1						1	Pneumonia; Sepsis; Urinary tract infection	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0232362	01/14/2005		76.0			M	10/10/2002	A report was received on 1/2/02 concerning a 76 year old male patient who experienced COPD exacerbation 6 days after receiving Fluvirin vaccine on 11/10/98. The causality assessment was stated as possible. (OMIC)									U	11/10/1998	11/16/1998	6		UNK	UNK	NONE		Chronic pulmonary heart disease.		PJP200200002	1						1	Condition aggravated	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232363	01/14/2005		72.0			M	10/10/2002	A report was received on 1/2/02 concerning a 72 year old male patient who experienced COPD exacerbation 7 days after receiving Fluvirin vaccine on 10/23/98. The event was considered serious (OMIC).									U	10/23/1998	10/30/1998	7		UNK	UNK	NONE		Chronic pulmonary heart disease.		PJP200200003	1						1	Condition aggravated	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232364	01/14/2005		77.0			M	10/10/2002	A report was received on 1/2/02 concerning a 77 year old male patient who experienced COPD exacerbation on 3/22/99 after receiving Fluvirin vaccine on 10/29/98. The event was considered serious (OMIC).									U	10/29/1998	03/22/1999	144		UNK	UNK	NONE		Chronic pulmonary heart disease		PJP200200004	1						1	Condition aggravated	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232365	01/14/2005		75.0			M	10/10/2002	A report was received on 1/2/02 concerning a 75 year old male patient who experienced COPD exacerbation (OMIC) 5 days after receiving Fluvirin vaccine on 12/9/98. The event was considered serious.									U	12/09/1998	12/14/1998	5		UNK	UNK	NONE		Chronic pulmonary heart disease		PJP200200005	1						1	Condition aggravated	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232366	01/14/2005		57.0			M	10/10/2002	A report was received on 01/02/02, from an unknown source concerning a 27 year old male patient who experienced influenza like illness the same day as he was administered Fluvirin vaccine on 12/04/98.									U	12/04/1998	12/04/1998	0		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200200006	1						1	Influenza like illness	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232367	01/14/2005		51.0			M	10/10/2002	A report was received on 1/2/02 concerning a 51 year old male patient who was hospitalized on 12/19/98 after a visit to the emergency room with Guillain Barre Syndrome which was considered life threatening after receiving Fluvirin vaccine on 10/27/98. (OMIC)			Y		Y				U	10/27/1998	12/19/1998	53		UNK	UNK	NONE		NONE		PJP200200007	1						1	Guillain-Barre syndrome	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0232373	01/14/2005	TX	35.0			F	01/14/2005	Redness and swelling of arm around vaccination site.									Y	11/30/2004	11/30/2004	0	pt has sickle cell disease	UNK	UNK			sickle cell			1						1	Anaemia; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1454AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232384	01/14/2005	MN	5.0	5		F	01/07/2005	Tender, swollen, erythematous, blanching area on left anterior thigh (max size: 11 x 15 cm) first noticed approximately 1 day after immunizations (cellulitis). Treatment with Clindamycin po 180 mg Q8 for 7 days. Information from Discharge summary states bacterial infection. msv				Y	Y				Y	01/04/2005	01/06/2005	2	Blood CX - No growth to date.	PUB	UNK		Cellulitis	ITP Information from Medical records states stomatitis and dehydration. msv			1						1	Bacterial infection; Cellulitis; Injection site discolouration; Injection site erythema; Injection site oedema; Tenderness	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14A009AA~5~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1458AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X03162~4~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0316P~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Hospitalisation	Influenza
0232387	01/14/2005	CT	63.0	62		F	01/10/2005	Adverse event was ring shaped hives on the abdomen that lasted for four weeks, they gradually fade away during this 4 week period without any treatment.									U	11/21/2004	11/22/2004	1		OTH	OTH	Atenolol, Actonel, Lipitor and Etia		Allergies to grass, dust and fur.			1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0232388	01/14/2005	GA	0.62	0	.6	F	01/07/2005	The patient had a 50 cent size area of erythema and edema at the site of injection within minutes of injection. No systemic symptoms.									Y	01/06/2005	01/06/2005	0	N/A	PVT	PVT	None per mother	None per mother	NONE			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1505AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232389	01/14/2005	MA	1.18	1	.2	M	01/07/2005	Localized erythema and swelling of the right arm. Recovering currently.									Y	01/05/2005	01/06/2005	1		PUB	UNK		Left otitis media with effusion	Single kidney and history of multiple urinary tract infections.			1						1	Injection site erythema; Injection site swelling	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~ACZ1A007AA~1~~RA~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1555~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE232AA~3~~LA~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0346P~1~~RA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA		Influenza
0232390	01/14/2005	NJ	28.0	27		F	01/10/2005	Flu shot given on 12/17/04 , two or three days later patient developed redness at site. The patient visited her PMD and was given Cephalexin 500mg BID for 10 days. Follow up on 01/10/05, the patient states site is without complication.				Y					Y	12/17/2004	12/19/2004	2		PUB	UNK	Cephalexin	NONE	NONE			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U1453DA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0232392	01/14/2005	ND	1.49	1	.5	M	12/24/2004	Patient received a flu shot IM in the left leg on 11/19/04. He developed muscle achiness, diarrhea for 1 day, and low grade fever 6 days after the vaccination. No local reaction at the injection site. Physician documented myositis, etiology viral versus influenza based. No further complication noted.				Y					Y	11/19/2004	11/28/2004	9	CPK 11/20/04 = 274, CPK 11/29/04 = 512, CPK 12/01/04 = 364	PUB	UNK		NONE			ND0429	1						1	Diarrhoea; Myalgia; Myositis; Pyrexia	FLU3~SANOFI PASTEUR~U1392AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0232393	01/14/2005	NH	29.0	28		M	01/09/2005	Patient experienced upper respiratory infection symptoms with a fever of 102.6.									U	01/08/2005	01/09/2005	1	NONE	MIL	MIL		NONE	NONE			1						1	Pyrexia; Upper respiratory tract infection	FLUN3~MEDIMMUNE VACCINES, INC.~500365P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0232394	01/14/2005	OK	22.0	21		F	01/07/2005	Client was given Flu-Mist, after which she found out she was pregnant. The client has had no adverse effects. Her EDC is 07/27/2005.									U	12/13/2004			Positive Pregnancy Test	PUB	UNK	NONE	NONE- Pregnant				1						1	Laboratory test abnormal; Unevaluable event	FLUN3~MEDIMMUNE VACCINES, INC.~500340P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0232395	01/14/2005	NY	43.0			F		This is a non serious spontaneous case from a consumer in the USA who reports experiencing post nasal drip (USA, Labelled). The reporter causality is not provided. This is a 43 year old female who experienced post nasal drip and cough approximately one week after receiving FluMist vaccine. The patient reported that the post nasal drip has been lessened but has been experiencing constant coughing and sore throat. Information from missing data report states all attempts to obtain follow-up have been unsuccessful. The patient will not give any information.									U					OTH	OTH	Concomitant Drug (s) Not reported		NI		MEDI0002654	1						1	Cough; Pharyngolaryngeal pain; Postnasal drip	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0232377	01/16/2005	NC	51.0	50		F	01/16/2005	Got the shot Monday, Jan 10, 2005 at noon. By late evening of the 11th I had aches, skin sensitivity, headache. Heavy cough started the next day. Hives developed Wednesday night. I took Tylenol. I was able to function relatively well until Saturday afternoon. I've stayed in Saturday afternoon and all day Sunday. Still have a headache, cough (from post-nasal drip?), and sore throat from coughing. I've had a moderate muscle pain all throughout.									U	01/10/2005	01/11/2005	1	None	UNK	UNK	zyrtec	None	none			1						1	Cough decreased; Headache; Hypersensitivity; Myalgia; Pain; Pharyngolaryngeal pain; Postnasal drip; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0232378	01/17/2005	NY	57.0	56		F	01/17/2005	Within 2 hours of administration of Pneumovax on January 13, 2005, pt experienced significant local reaction at site (right upper arm), with swelling, redness, itching,pain, warmth and firm to touch. Swelling was sufficient to produce tightness of shirtsleeve; hand laid over the area and noted firmness beneath entire surface of hand. RN who administered the Pneumovax contacted Health Dept. for recommendations. They recommended cold pack to area, which was done immediately. Pt was also instructed to call her Primary Physician for an appropriate antihistamine order, which she did. She took Benadryl 50mg (2-25mg gelcaps) when she got home from work. Improvement noted by the following morning, with continued improvement until area was resolved on 01/17/05.									Y	01/13/2005	01/13/2005	0	None	UNK	UNK	Diltiazem 240mg po QD (bedtime) Hydrochlorothiazide 50mg po QD (AM)	none	NKA, Hypertension, Borderline Diabetes			1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site pain; Injection site reaction; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U1532AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0926N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0232380	01/17/2005	RI	47.0	47		M	01/17/2005	SORE THROAT AND NASAL CONGESTION APPROX 24 HRS AFTER RECEIVING VACCINE. SYMPTOMS LASTED APPROX 48 HRS									Y	01/14/2005	01/15/2005	1		UNK	UNK	PRILOSEC, TOPROL XL, LIPITOR, ASPIRIN		GERD, HYPERTENSION, HIGH COLESTEROL			1						1	Nasal congestion; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~UNKNOWN~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0232385	01/17/2005	IL	50.0	49		F	01/17/2005	Arm red and swollen to elbow area fingers swollen next A.M.									U	01/12/2005	01/12/2005	0		PUB	PVT		None	Penicillin and many others			1						1	Erythema; Swelling	FLU3~SANOFI PASTEUR~U1462AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232386	01/17/2005	IL	32.0	32		F	01/17/2005	Warm at site and upper body, face and chest sweats									Y	01/12/2005	01/12/2005	0		PUB	PUB		None				1						1	Hyperhidrosis; Injection site warmth	FLU3~SANOFI PASTEUR~U1462AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232391	01/17/2005	NY	58.0	57		F	01/17/2005	Patient with Positive flu symptoms, beginning approximately 1-1 1/2 after receiving shot.  A order: runny nose, sneezing, chills, bad headache, fever of 101 degrees, body aches.  Call her PCP.  No antiviral.  Bed rest no MD visit. Out of work x 4 days.									Y	01/11/2005	01/11/2005	0		PUB	PVT	Fosamax	No	Denies			1						1	Chills; Headache; Influenza; Pyrexia; Rhinorrhoea; Sneezing	FLU3~SANOFI PASTEUR~U1383AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232424	01/18/2005	FL	74.0	73		F	01/17/2005	From initial information received on 1/10/05 from the patient's son regarding an adverse event, it was reported that this 74 year old female patient received FLUZONE, lot number U1552AA, administered IM on 12/10/04. Four to five days later, the patient developed fatigue, weakness, and a poor appetite and was hospitalized. She also developed influenza and a staph infection, but the onset dates were not provided. The patient's recovery status is unknown.					Y				U	12/10/2004	12/15/2004	5		UNK	UNK	Glucophage; Glipizide; Prednisone; Fosamax; Cardizem; Lasix; Theophylline, Combivent; Bromide; Albuterol Sulfate		The patient has a history of asthma and is borderline diabetic. She is also allergic to aspirin. She receives a flu shot every  year.		200500095	1						1	Asthenia; Bacterial infection; Decreased appetite; Drug ineffective; Fatigue; Influenza; Anorexia; Atelectasis; Atrial fibrillation; Chest pain; Contusion; Cough; Dyspnoea; Hyperglycaemia; Hyperhidrosis; Hypoalbuminaemia; Hyponatraemia; Laboratory test abnormal; Lethargy; Metabolic alkalosis; Myalgia; Oedema peripheral; Pain; Pleural effusion; Pneumonia; Skin ulcer; Urinary tract infection	FLU3~SANOFI PASTEUR~U1552AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1552AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0232425	01/18/2005	NY	66.0	65		F	01/18/2005	On 01/12/05 (two days after vaccination) patient noted her left arm was red, sore and warm to touch.  Area of redness was approximately 4 x 7.  On 01/14/05 she returned to clinic and was advised to see her PMD.  She saw her PMD on this date and was told her arm was infected.  She was prescribed Amoxicillin/clavulanate 875/125 mg. which she has been taking.  At time of interview, 01/18/05, patient states her arm is improving.				Y					Y	01/10/2005	01/12/2005	2	None	UNK	UNK	None	None	None			1						1	Infection; Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U1459AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~MASS. PUB HLTH BIOL LAB~Td119~UNK~ID~LA~TD ADSORBED (TDVAX)~1	USA	Emergency room visit	Influenza
0232428	01/18/2005	GA	65.0	65		M	01/18/2005	Patient experienced severe and recurring pain in the left deltoid muscle for 3 months after vaccine was administered.  Patient was referred to orthopedist after 2 months, treated with methylprednisolone, treatment ongoing. Information from medical records states pain, reduced range of motion. msv								Y	N	10/14/2004	10/14/2004	0	X-rays of left deltoid, shoulder	UNK	UNK	None	None	None Informationfrom medical records states sarcodosis, glaucoma as conditions. msv			1						1	Joint range of motion decreased; Myalgia; Pain	FLU3~SANOFI PASTEUR~U1440AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0232432	01/18/2005	OH	2.0	2	.2	M	11/15/2004	On 11/15/04 I received a telephone call from the patient's mother requesting information about the flu shot her son received in December of 2003 here at our health department. Her son received a flu shot 0.25ml, right deltoid, IM, on 12/12/03. According to the mother, one week later her son developed redness around his eyes and within 2 weeks of receiving the flu shot, rash occurred on his face and body. Mother claims no other symptoms were noted at this time. She took him to see the doctor on 12/24/03 and was told that her son was allergic to Dilantin that he took for his seizure disorder. According to the mother, her son was taken off of the Dilantin and started on a new seizure medication. The following day, 12/25/03, her son had multiple seizures. The parents contacted a doctor who was on call. The parents gave their son valium that they had at home. The mother told me that due to bad winter weather and the Christmas holiday, they did not take their son to the hospital until the following day. The mother told me that her son was hospitalized for 2 months. He was released to rehab where he was promptly admitted to ICU for respiratory distress. He was released the day before Mother's Day 2004.  According to the mother, her son has been a patient of several local pediatricians. The most recent doctor referred him to our health department for a flu shot. He was a patient of another doctor when he was first diagnosed with a seizure disorder after his third set of shots. The mother believes that those shots caused the seizures. The mother told me that the doctors do not know what caused the crisis for her son and that none of the doctors told her that the flu shot caused a severe reaction. She has scheduled an appointment with a specialist in vaccine reactions. She was instructed by another doctor to obtain the information about the vaccine and then file report online. The mother was not able to say if the report was the same as the VAERS. The patient is currently at home. His trach was reversed and he is breathing on his own. He can eat finely chopped foods, but continues to receive tube feedings. According to his mother, he operates at a 5 month level. He received PT, OT, and Speech therapies. I was informed he was being seen by a neurologist. The neurologist has declined to discuss the case at this time. 60 Day Follow Up: I phoned mother this afternoon and asked how her son was doing and what was the outcome of Dr's evaluation. Mother proceeded to tell me that pt has been evaluated by Dr's. Pt visits this group of doctors weekly for treatment. He will begin chelation therapy for mercury poisoning next week. The mother has believed right along that pt was suffering from Guillain Barre Syndrome and she stated that the doctor's are now thinking this too. Mother stated that pt's recovery has been slow and that he now operates at approx a 10 month old level. Last time she and I spoke mother said that pt was at a 5 month old level. He continues to be fed by G-tube and goes to weekly sessions for PT, OT and speech therapy at hospital. She said that the family is going to seek compensation to help pay for the treatments. Information from Discharge summary states fever, encephalopathy, respiratory failure.  Information received from Medical records state decreased vision, decrease in hearing, neurologicl regression, scarlet fever, edema of face, abnormal gait; stridor and irritability. msv Per follow up report-Patient's mother beleives improvement has been slow. Child does not connect to his environment and is not talking according to her. He started walking in May '05 and had the tracheotony removed. He continues chelation therapy at Dr's office. Since the start of the chelation therapy they have been able to decrease patients seizure meds and he appears more alert according to his mother.			Y	Y	Y	74			N	12/12/2003			UNK Information from Medical records states abnormal lab results. msv	PUB	PUB	Dilantin	NONE	Seizure disorder according to mother. Information from medical records states allergy.			1						1	Agitation; Apnoea; Chelation therapy; Convulsion; Deafness; Decreased appetite; Drug toxicity; Dyspnoea; Encephalopathy; Face oedema; Gait disturbance; Hypersensitivity; Laboratory test abnormal; Ocular hyperaemia; Pyrexia; Rash; Speech disorder; Thinking abnormal; Tracheostomy tube removal; Viral infection; Visual disturbance	FLU3~SANOFI PASTEUR~U1270AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0232434	01/18/2005	OR	44.0	43		F	12/08/2004	Patient was given the flu vaccine in her left upper arm at 08:30 on 12/08/2004. Reports the injection was more painful than usual. After returning to work had increasing radiating pain in shoulder, neck and chest. Not relieved with heat/cold, Ibuprofen or vicodin.				Y					Y	12/08/2004	12/08/2004	0		PUB	OTH						1						1	Chest pain; Injection site pain; Neck pain; Pain	FLU3~SANOFI PASTEUR~U1553AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0232435	01/18/2005	MA	69.0	69		F	11/17/2004	Left arm - deltoid area: Hot to the touch, red and purple color, hard, swollen, itchy				Y					Y	11/16/2004	11/17/2004	1		PUB	OTH	Lantus Protonix Levoxyl Diovan Zeta		Diabetes, Hypertension, Bilateral renal arterial stenosis, Allergies: Penicillin, Sulfa, Codeine, Latex		MA0501	1						1	Erythema; Feeling hot; Injection site induration; Pruritus; Skin discolouration; Swelling	FLU3~SANOFI PASTEUR~U1555AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0232436	01/18/2005	NJ	26.0	26		F		Patient received Flu shot on 01/10/2005 -returned on 01/12/2005 with approximately 2 X 3 red/warm/raised area at location of injection. Seen by doctor who prescribed Benadryl pills and ointment or Amoxicillin 250 mg BID for 5 days.									U	01/10/2005	01/10/2005	0		PUB	UNK			All erythomycin			1						1	Feeling hot; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U1455AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232437	01/18/2005	LA	45.0	44		M	01/10/2005	Raised rash on arms, facial flush, sweating, c/o feeling hot and prickly, doses of epinephrine									Y	01/10/2005	01/10/2005	0		PUB	PUB	Univasc 7.5, decrease flush, Niacin in past	NONE	HBP, increases triglycerides		LA050104	1						1	Feeling hot; Flushing; Hyperhidrosis; Paraesthesia; Rash erythematous	FLU3~SANOFI PASTEUR~U1531AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232440	01/18/2005	MI	65.0	65		F	12/10/2004	Pt noticed 2 hives (red, raised area 1 1/2-2) with mild swelling of hive area only, on left bicep and very small discoloration described as appearing like a bruise on inner aspect of left elbow in evening on 12/1/04. Did not feel ill. No self treatment. Did not consult medical provider. States all discoloration, swelling/hives resolved by AM of 12/2/04.									N	12/01/2004	12/01/2004	0		PUB	PUB	Clonidine, Baby ASA, Anathyroid, multivitamin	NONE	Allergy: PCN, mold, medical conditions: HTN, hypothyroidism (Hashimoto's disease)		MI2004070	1						1	Contusion; Erythema; Injection site oedema; Skin discolouration; Urticaria	FLU3~SANOFI PASTEUR~U1579AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0514P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0232441	01/18/2005	MI	63.0	62		F	12/22/2004	C/o not able to lift right arm above shoulder area last 5 days. Injection site did not show: inflammation, discharge, bruising, per pt.									U	12/15/2004	12/18/2004	3	NONE	PUB	PUB	Lipitor	NONE	Bursitis, Arthritis upper extremities		MI2005001	1						1	Hypokinesia	FLU3~SANOFI PASTEUR~U1521AB~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232458	01/19/2005		48.0	48		F	10/10/2002	On 12/10/01 a report was received from a nurse regarding a 48 year old female patient who experienced flu-like symptoms after receiving the Fluvirin vaccine on 11/5/01. The patient has a history of hypertension and was taking Hyzaar for it. The patient was also taking Premarin, Allegra and Flonase. Previous exposure to the suspect product is unknown. The patient received the Fluvirin vaccine on 11/5/01 IM at the left deltoid muscle. On the same night, the patient experienced fatigue. On 11/01 the patient experienced radiating pain from the left shoulder down the left arm, then flu-like symptoms of aches and pain over the body. Some time later it was difficult for the patient to raise her left arm, and the left deltoid muscle became swollen and inflamed. The patient then developed a mass (size of a tennis ball) on the bottom side of the left arm and a sensation of fluid rushing around the chest. The patient recovered from the symptoms on 11/20/01. The reporter has assessed the causality relationship as possible because of the short time span between the injection and the first symptom.									Y	11/05/2001	11/05/2001	0		UNK	UNK	Premarin; Hyzaar; Allegra; Flonase		Hypertension		PJP200200051	1						1	Hypokinesia; Influenza like illness; Injection site inflammation; Pain; Swelling	FLU3~EVANS VACCINES~E06731KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232462	01/19/2005		53.0	53		F	10/10/2002	A consumer report was received on 12/19/01 regarding a 53 year old female patient who experienced dizziness after receiving a Fluvirin vaccine on 12/3/01. The patient has a medical history of asthma for which the patient was taking inhalers, allergy for which the patient was taking Claritin and Atarax and hypertension for which the patient was taking Diovan. The patient had a flu injection of unknown source in 1976 without any adverse events. The patient received the Fluvirin vaccine on her upper arm on 12/3/01 and on the morning of 12/4/01 the patient experienced dizziness and had to stay in bed for two days. On 12/5/01 the patient was seen by her family doctor who diagnosed the patient with labyrinthitis and told the patient it could have been caused by the flu injection. The patient was seen again by the same doctor on 12/14/01, who suspected a possible ear infection but could not make a diagnosis. The patient was prescribed Antivert and Ceftin. The patient had not recovered at the time of reporting the event and still experienced dizziness when making a sudden move. There was insufficient information to determine the reporter's causality assessment.									N	12/03/2001	12/04/2001	1		UNK	UNK	Claritin; Atarax; Diovane; Asthma inhalers		NONE		PJP200200061	1						1	Dizziness; Labyrinthitis	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232465	01/19/2005		47.0	46		F	10/10/2002	A report was received from a physician's assistant on 1/3/02, concerning a 46 year old female who experienced pain, numbness, and tingling from fingertips to shoulder, two to three days after receiving Fluvirin on 11/28/01. The patient had a history of myalgia. On 11/28/01, the patient received a Fluvirin injection in her right deltoid muscle. After two to three days the patient experienced discomfort and pain throughout the whole right arm. The patient was prescribed mobic 7.5mg 1 tablet once or twice daily, however, at the time of the report, the patient was still experiencing the same, although milder symptoms. The patient received a flu vaccination of another source on 10/13/00 without an adverse event. There was insufficient information to determine the reporter's causality assessment.									N	11/28/2001	11/28/2001	0		UNK	UNK	NONE		Disorders of Muscle, Ligament, and Fascia unspecified		PJP200200065	1						1	Discomfort; Hypoaesthesia; Pain; Paraesthesia	FLU3~EVANS VACCINES~E04851KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232471	01/19/2005		23.0			M	10/10/2002	A report was received from a health care professional on 1/14/02 concerning a 23/24 year old male patient, who received an overdose of Fluvirin on 1/11/02. On 1/11/02, the patient inadvertently received Fluvirin 5ml instead of Fluvirin 0.5ml. The patient experienced no adverse reaction, but will be monitored closely for any adverse events. There was insufficient information to determine the reporter's causality assessment.									U	01/11/2002	01/11/2002	0		UNK	UNK	NONE		NONE		PJP200200095	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~E12831MA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232473	01/19/2005		1.3			M	10/10/2002	A report was received from a health care professional on 1/15/02 regarding a 16 month old male patient who had an off label use and subsequent overdose after receiving a Fluvirin vaccine on 12/5/01. The patient did not demonstrated any untoward effects at the time of administration and the patient's mother was instructed to monitor the infant for unusual problems/behavior or symptoms. She has not reported any to the doctor or reporter. On 12/5/01, the patient received 0.5ml (adult dose) of Fluvirin vaccine instead of 0.25ml (child's dose) this represents an off-label use as Fluvirin is indicated for use in children 4 years and older. There were no adverse events reported at the time of reporting. There was insufficient information to determine the reporter's causality assessment.									U	12/05/2001	12/05/2001	0		UNK	UNK	NONE		NONE		PJP200200102	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~E12471MA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232475	01/19/2005		1.3			M	10/10/2002	A report was received from a health care professional on 1/15/02 concerning a 16 month old male patient who experienced an overdose and off-label use of Fluvirin on 12/5/01. On 12/5/01, the patient received 0.5ml (adult dose) of Fluvirin instead of the CDC recommended dose of 0.25ml (for children). In addition, this was an off-label use of Fluvirin, since Fluvirin is indicated for use in children 4 years and older. The patient did not demonstrate any untoward effects at the time of administration, and the mother was instructed to monitor the infant for unusual problems, behavior or symptoms. At the time of reporting the mother had not reported any adverse reactions.									U	12/05/2001	12/05/2001	0		UNK	UNK	NONE		NONE		PJP200200106	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~E1247MA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232476	01/19/2005		64.0			U	10/10/2002	A report was received from a health professional on 1/15/01 concerning a 64 year old patient who experienced a bitter taste after receiving Fluvirin on 10/18/01. The patient was receiving human insulin, isophane, losartan potassium, furosemide, acetylsalicylic acid, atenolol, ranitidine hydrochloride, gabapentin and amitryptiline concomitantly. The patient has a previous medical history of hypertension, gastroparesis, diabetes, diabetic retinopathy, diabetic neuropathy, osteoarthritis, esophageal spasm, hiatal hernia, chronic pain, chronic cough, melanosis of colon, chronic palpitations, poor dentition, and nephrolithiasis. On 10/27/01, the patient complained of a bitter taste in her mouth that developed one week after receiving the influenza vaccine. The patient was reported as having no complaints of dysphagia, odynophagia or any other adverse events. At the time of reporting, the adverse event was not resolved. The reporter assessed the causality as unclassifiable.									U	10/18/2001	10/18/2001	0		UNK	UNK	Humulin; Insulin; Cozaar; Lasix; ASA; Atenolol; Zantac; Neurontin; Amitriptyline		Gastrointestinal complications; Diabetes; Diabetic Retinopathy; Nervous System Disorders; Osteoarthritis; Functional Disorders of Esophagus; Congenital Hiatus Hernia; Pain; Cough; Irritable colon; Palpitation; Renal disease; Hypertension		PJP200200107	1						1	Dysgeusia	FLU3~EVANS VACCINES~E06731KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232477	01/19/2005		1.3			F	10/10/2002	A report was received from a health care professional on 1/15/02 concerning a 16 month old female patient who experienced an overdose and off-label use of Fluvirin on 12/5/01. On 12/5/01, the patient received 0.5ml (adult dose) of Fluvirin instead of the CDC recommended dose of 0.25ml (for children). In addition, this was an off-label use of Fluvirin, since Fluvirin is indicated for use in children 4 years and older. The patient did not demonstrate any untoward effects at the time of administration, and the mother was instructed to monitor the infants for unusual problems, behavior or symptoms. At the time of reporting the mother had not reported any adverse reactions.									U	12/05/2001	12/05/2001	0		UNK	UNK	NONE		NONE		PJP200200108	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~E1247MA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232478	01/19/2005		60.0			M	10/10/2002	A report was received from a consumer on 1/21/02 concerning a 60 year old male patient who experienced a sore throat, cough, headache, and sinus pain after receiving Fluvirin vaccine on 11/1/01. The patient stated that he had experienced the same symptoms in the past several years despite receiving influenza vaccines of unknown manufacturers. On 11/1/01, the patient received a Fluvirin vaccine and on 12/24/01 the patient developed a sore throat which lasted for 3 days. Two days later the patient experienced low grade fever, chest congestion, and cough which lasted for 2.5 weeks. The patient visited his physician and he diagnosed influenza infection. One week later the patient developed headache, sinus pain, and slight body ache. These symptoms have currently subsided but are not resolved. The patient did not receive any treatment for his symptoms. The patient had not recovered at the time of reporting the event. The reporter's causality assessment is probable.									U	11/01/2001	12/24/2001	53		UNK	UNK	Glucosamine		NONE		PJP200200112	1						1	Cough; Headache; Influenza; Nasal congestion; Pain; Pharyngolaryngeal pain; Pyrexia	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232479	01/19/2005		64.0			F	10/10/2002	A report was received from a health professional on 1/7/02 concerning a 64 year old female patient who experienced an inadvertent administration of Fluvirin, most of the vaccine accidentally spilling out onto the patient's arm when the syringe plunger was pulled by the medical assistant. The patient did not complain of any adverse event at the time of administration.									U					UNK	UNK	NONE		NONE		PJP200200115	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232480	01/19/2005					U	10/10/2002	A health professional was received on 1/25/02 concerning a patient of unknown demography who was inadvertently administered an overdose of Fluvirin vaccine in late November/early December 2001. The patient received a 1ml dose of Fluvirin in late November/early December 2001 and did not complain of any adverse event at the time of administration. The patients medical history was not reported. The reporter assessed the causality to be unclassifiable.									U					UNK	UNK	NONE		NONE		PJP200200116	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232481	01/19/2005					U	10/10/2002	A report was received from an health care professional on 11/26/01 concerning 3 patients who inadvertently received Fluvirin SC. The patient's did not complain of any adverse events at the time of administration. There was insufficient information to determine the reporter's causality.									U					UNK	UNK	NONE		NONE		PJP200200117	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232482	01/19/2005		45.0	44		F	10/10/2002	A health professional form was received on 11/29/01 concerning a female patient who was inadvertently administered Fluvirin SC instead of IM in October 2001. In October 2001, the patient received a SC administration of Fluvirin vaccine and did not complain of any adverse effects at time of administration. The reporter assessed the causality to be unclassifiable.									U	10/01/2001	10/01/2001	0		UNK	UNK	NONE		NONE		PJP200200118	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0232508	01/19/2005	NY	0.75	0	.8	M	01/10/2005	High fever, swelling of hands and feet within 48 hours of shot. Possible serum sickness. Blood culture showed meningococcemia (group B). Pt received Steroids and Ceftriaxone. Discharge Summary received on 2/8/2005 states rash.				Y	Y	2			Y	12/28/2004	12/30/2004	2	Positive blood culture. Medical Records received on 2/8/2005 states leukocytosis.	PUB	PUB		Cold symptoms	NONE			1						1	Bacterial infection; Laboratory test abnormal; Leukocytosis; Oedema; Pyrexia; Rash; Sepsis; Serum sickness	FLU3~SANOFI PASTEUR~U1560AB~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0232509	01/19/2005	MN	0.5	0	.5	F	01/04/2005	Low grade fever and very cranky immediately after vaccination that lasted 7 days. 7 days after vaccination, she started having seizures and was hospitalized. 14 days after vaccination, MRI of head showed diffuse white matter abnormalities. Since then, she has lost all physical abilities. She can not hold her head up, does not eat by mouth (has G-tube), does not smile, lost her sight and has hypotonia. She has been tested for numerous diseases but all test results are negative thus far. White matter of brain is continually decreasing. Information from medical records state developmental delay.  Per follow up report-Patient passed away 10-12-05. Gene mutations were found that caused the disease vanishing white matter disease. This disease was triggered by the onset of Influenza within a few days after getting the Influenza vaccine. Although patient would have presented with the symptoms of this disease eventually it is believed that getting the flu vaccine is what triggered the symptoms earlier.  8/10/07 Received Death Certificate which reveals COD as Vanishing White Matter Disease.	Y	10/12/2005	Y	Y	Y	40	Y	Y	N	12/10/2003	12/17/2003	7	She has had genetic testing for all known Leukodystrophies multiple times - results negative. Has been tested for any/all diseases and disorders that can cause damage to white matter of the brain - all negative. Information from medical records state neutropeni. 2/5/07 Received labs from ME office which reveal: 8/15/04 unremarkable RBCs; vacuolated monocytes; unremarkable plts. 3/23/05 absolute neutropenia, marked; absolute monocytosis, mild; & apparently normal RBC & plts.	PUB	PVT	Cefzil for possible left ear infection.	Left ear slightly pink, possible ear infection Information from medical records state otitis media.	NONE PMH: leukodystrophy, seizures, leukoencephalopathy, neutropenia.			1						1	Blindness; Convulsion; Delirium; Developmental delay; Gene mutation identification test positive; Growth retardation; Hypokinesia; Hypotonia; Irritability; Neutropenia; Oral intake reduced; Pyrexia	DTAP~GLAXOSMITHKLINE BIOLOGICALS~622B2~3~~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1128AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0232510	01/19/2005	AK	57.0	57		F	01/19/2005	Arm hurts like shot in muscle. I am left handed, it hurts to write, hook my bra, hook passenger seat belt, can't read over to right shoulder. It hurts all the time if I'm using left arm. Hurts most when arm is drawn back and any pressure applied. Can still find shot site, tired of it hurting.									U	10/27/2004	10/28/2004	1		OTH	PVT			Penicillin, sulfa, diabetes, high blood pressure			1						1	Hypokinesia; Injection site pain; Myalgia	FLU3~SANOFI PASTEUR~U1443AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232511	01/19/2005	CA	57.0	57		F	01/13/2005	Large, red, raised hives, covering entire body the day after flu shot and has continued for 8 days so far. Treated with Benadryl as recommended by clinic				Y					U	01/06/2005	01/07/2005	1		OTH	OTH		NONE	NONE			1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0232513	01/19/2005	OR	70.0	69		F	01/02/2005	Fever, severe congestion (pneumonia ?), slept 2 days, could not eat (3 days). Almost died, slept 3 days c/o weakning, high fever, sweats, weak for 3 months.			Y						Y	10/14/2004	10/15/2004	1	Elevated blood sugars 300's	OTH	PVT	Medicare					1						1	Anorexia; Blood glucose increased; Nasal congestion; Pneumonia; Pyrexia; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0232514	01/19/2005	AL	1.13	1	.1	M	01/11/2005	Within 2 hrs after vaccine, protracted screaming episode. These continued almost daily for 6 weeks. Had blistering skin lesion on right great toe within 2 days. EGD after 1 month revealed multiple gastric ulcers, and CBC showed neutrogen (ANC 200 to 800) which has persisted. Has seen GI and heme-one, no explanation found, but is asymptomatic now.				Y					N	10/22/2004	10/22/2004	0	EGD after 1 month revealed multiple gastric ulcers, and CBC showed neutrogen (ANC 200 to 800) which has persisted.	PVT	PVT		NONE	NONE			1						1	Blister; Crying; Gastric ulcer; Laboratory test abnormal; Screaming; Skin ulcer	FLU3~SANOFI PASTEUR~U1410BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0232515	01/19/2005	MS	34.0	34		M	01/09/2005	15 minutes after FluMist administration states skin became red and felt as if something was crawling on skin. Coworkers state was momentarily mentally foggy (disoriented). States episode last 15-20 minutes and felt bad the rest of day. No treatment.									Y	01/07/2005	01/07/2005	0	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Disorientation; Erythema; Malaise; Paraesthesia	FLUN3~MEDIMMUNE VACCINES, INC.~500365P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0232516	01/19/2005	IN	41.0	40		F	01/10/2005	Rash, pustular (3-5 noted at injection site), 3 days after. No pain in arm, By 1/1/05 opened and drained, drained again Saturday 01/08/05. Cleaned with alcohol, soap and H20, denies arm feeling bad, seen by MD, 1/10/05, no treatment, released.				Y					Y	12/28/2004	12/30/2004	2		MIL	PVT	Synthroid 0.1mg, BCP, Effexor, Nicomide, Multivitamin		Sulfa, hypothyroid			1						1	Rash pustular	FLU3~SANOFI PASTEUR~U1418AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0232517	01/19/2005	AZ	47.0	46		F	01/06/2005	11/19/04 swelling, itching, redness left upper outer arm in the evening. Area hot to touch. Used Benadryl Cream. 12/1/04 symptoms resolved.									Y	11/19/2004	11/19/2004	0		PVT	PVT	Nexium prn		Environmental allergies in childhood: grasses, mold			1						1	Feeling hot; Injection site erythema; Injection site oedema; Pruritus	FLU3~SANOFI PASTEUR~U1504AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232518	01/19/2005	TX	52.0	52		F	01/11/2005	Pt called about an hour after receiving vaccine c/o flushing and diaphoresis.									U	01/11/2005	01/11/2005	0		PVT	UNK		NONE	Congenital ASD, Multiple sclerosis; high chol, HTN, Obesity			1						1	Flushing; Hyperhidrosis	FLU3~SANOFI PASTEUR~U1519AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232519	01/19/2005	AZ	71.0	70		F	01/11/2005	Pt sts left arm is very sore and hard to move.				Y					U	12/21/2004	12/21/2004	0	Doppler ultrasound of left upper extremity	PUB	OTH	NONE	NONE	NONE			1						1	Hypokinesia; Injection site pain; Hypokinesia; Injury; Pain; Thermal burn	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1529DA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0232519	01/19/2005	AZ	71.0	70		F	01/11/2005	No immediate reaction.  Pain started between wrist & elbow.  Progressively worse - difficulty raising arm, painful to comb hair, burning at night.  Has seen PCP, most recently neurologist. negative findings.  Except neurologist said punctured bursa during shot									U	12/21/2004	12/21/2004	0	ultrasound, x-ray - negative	UNK	UNK		None	None - no falls or previous shoulder problems		AZ0411	1						2	Hypokinesia; Injection site pain; Hypokinesia; Injury; Pain; Thermal burn	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1529DA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0232520	01/19/2005	MA		0	.7	F	01/14/2005	12/2/04 flu vaccine given, 12/04/04, developed hives over body, seen at Pedi office, gave Benadryl, rash test to eggs done 12/6 was negative. 1/10/05 2nd flu vaccine given 1/11 developed hives treated over phone.				Y					Y	12/02/2004	12/04/2004	2	Rash test to eggs 12/6 was negative	PVT	UNK		NONE	NONE			1						1	Urticaria; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U1391AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0232521	01/19/2005	CA	52.0	52		U		Received FluMist 9Dec on 20Dec had development of ataxia and vertigo seen in ER next morning.  Information recieved from Medical records state myasthenia.				Y					U	12/07/2004	12/20/2004	13	Lab test, brain scan, neurology referred.	MIL	MIL		NONE	NONE Information received from medical records state injury accident, otitis media.			1						1	Coordination abnormal; Myasthenic syndrome; Vertigo	FLUN3~MEDIMMUNE VACCINES, INC.~5003579~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0232522	01/19/2005	NE	45.0	45		F	01/11/2005	Received flu vaccine 10/2004, since that time a dull, non-descript aching and muscle heaviness lt upper arm on over shoulder, down toward left breast. Small area of out pouching on left breast nipple. Breast tissue aches most of all. Started day shot was given.									U	10/06/2004	10/06/2004	0	NONE	PUB	PVT	NONE	NONE	NONE			1						1	Breast disorder female; Breast pain; Injection site pain; Sensation of heaviness	FLU3~SANOFI PASTEUR~U1380AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232532	01/19/2005	KY	44.0	43		F	12/17/2004	After giving me the flu vacine, the nurse took her fingers and massaged the area really hard.  She was massaging it so hard, it was painful.  Since that time, I have had severe muscle pain in my arm at the site of the injection.  The pain so severe, I have a hard time using my arm.									N	12/17/2004	12/17/2004	0	Comtemplating seeing a physician	UNK	UNK						1						1	Hypokinesia; Injection site pain; Myalgia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0232567	01/20/2005	NY	1.25	1	.3	M	01/14/2005	hives, Benadryl, Zyrtec 2.5ml qd bid, Zantac 1.5ml bid				Y					N	01/12/2005	01/12/2005	0		PVT	PUB	NONE	NONE	PCN allergic			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1531AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0469P~1~IM~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0232577	01/20/2005	MD	44.0	44		M	01/20/2005	Patient experienced high fever (3 days), severe headache, congestion, cough and bronchial irritation/burning.				Y					Y	01/08/2005	01/10/2005	2		MIL	MIL			Left Bundle Branch Block			1						1	Bronchiolitis; Cough; Headache; Nasal congestion; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500365~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0232578	01/20/2005	OH	53.0	52		M	01/20/2005	I got a influenza shot on 1/18/05 @ hospital @ about 2:50 pm and woke up @ 10:00 pm that night sick, with fever and chills and severe vomiting, then again around midnight and 3:00 am. The next day I had dizziness, fever, chills and weakness and the smell or mention of food made me want to vomit even more, I had a bowl of soup and water only all day. Now day 3 I feel like a new man healhy but a bit weak understandably so but I have to wonder if the flu shot actualey gave me the flu? I have not felt this sick in years and this was the first time I ever got the shot.									Y	01/18/2005	01/18/2005	0		UNK	UNK						1						1	Asthenia; Chills; Dizziness; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0232580	01/20/2005	NM	45.0	44		F	01/20/2005	Patient experienced a rash and urticaria on arms and back after the administration of Pneumovax.  The patient had no other problems prior to this.				Y					Y	01/20/2005	01/20/2005	0	None	UNK	UNK	ibuprophen, methocarbamol, calcium carbonate, insulin (NPH) simvastatin, glyburide/metformin	None	NKDA	urticaria, rash~Pneumo (Pneumovax)~1~0.00~In Patient		1						1	Rash; Urticaria; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U1479AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0691P~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0232582	01/20/2005	KS	87.0	86		F	01/20/2005	Pt admitted s/p an allergic rxn to flu vaccine.  She experienced sudden onset shortness of breath and wheezing.  She was transferred from the nursing home to emergency room, where, despite corticosteroid injection, epinephrine inj and aerosol treatments, she was still wheezing and somewhat sob.  It was decided to admit her.  Her O2 sats remained above 90% during this, and there was no respiratory arrest.  During her stay, she gradually improved and was discharged back to the nursing home 12/17/04. Discharge summary states Bronchitis. msv					Y	2			Y	12/15/2004	12/15/2004	0	Medical records state increased WBC'x, increased glucose, abnormal lab tests. msv	UNK	UNK			Discharge summary states hypothyroidism. msv Medical records state dementia, glaucoma. msv			1						1	Bronchitis; Dyspnoea; Hyperglycaemia; Hypersensitivity; Laboratory test abnormal; Leukocytosis; Wheezing	FLU3~SANOFI PASTEUR~U1SS2AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0232583	01/20/2005	GA	1.4	1	.4	F	01/20/2005	Patient received the MMR, DT, Hib, and influenza vaccinations on 01/12/05.  The patient returned on 01/13/05 with the left side of her face swollen - diagnosed as parotitis.  No treatment was given.  Patient was also diagnosed with Bronchiolitis that same visit and was treated with xopenex nebs at home via a home nebulizer.				Y					U	01/12/2005	01/13/2005	1	serum amylase was 653	UNK	UNK	none	Yes, patient diagnosed with Bronchiolitis	none			1						1	Bronchiolitis; Face oedema; Parotitis	DTAP~SANOFI PASTEUR~U1043AA~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1427AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE277AA~4~IM~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0313P~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0231786	01/21/2005	MA	63.0	63		F	01/11/2005	Dizzy Hoarse voice Physician notified by phone 11:30AM on 01/01/2005.  No local reaction noted.  Advised to call primary doctor if increased dizziness advised to gargle with salt water.									Y	12/31/2004	01/01/2005	1	NONE	PVT	PVT	Patenol eye drops Flonase Nasal Spray Allegra	Not known	Grass Trees Weeds Dust Mites Molds Asthma			1						2	Dizziness; Dysphonia; Dizziness; Dysphonia	FLU3~SANOFI PASTEUR~U1516AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1516AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0232591	01/21/2005	WI	25.0	25		F	02/02/2004	From initial information received on 01/28/04 from another manufacturer ( case number A0442068A) regarding an adverse event occurring in the USA, it was initially reported by a health care professional that a 25 year old female patient received Menomune A/C/Y/W-135, lot number not reported, administered in the left arm; Typhim VI, lot number not reported, administered in the right arm; Influenza Vaccine, lot number not reported, manufacturer unknown, administered in the left arm; a first dose of Engerix B, lot number ENG5460A (lot number incomplete), manufacturer GlaxoSmithKline, administered in the right are; all on 11/28/03. Later taht evening th patient developed a headache, low grade fever and achiness. The following day, on 11/29/03, the patient developed hives and itching on her torso and other parts of her body. On 11/30/03, the patient developed a swollen lymph node (site not reported), and a raised wheal at the injection site of her left arm. As of 12/03/03, the hives and itching have improved. The patient's recovery status was not reported.									U	11/28/2003	11/28/2003	0	Unknown	UNK	UNK			The patient's concurrent conditions and current medications were not reported; patient has no yeast allergy, however she is allergic to penicillin.		200400383	1						1	Headache; Injection site swelling; Lymphadenitis; Pain; Pruritus; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~5460A~2~~LA~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~786A4~2~~RA~HEP A (HAVRIX)~1|MEN~SANOFI PASTEUR~~UNK~~LA~MENINGOCOCCAL (MENOMUNE)~1|TYP~SANOFI PASTEUR~~UNK~~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0232592	01/21/2005	PA	44.0	44		F	03/11/2004	From initial information received on 01/29/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 45 year old female patient received a second dose of Menomune A/C/Y/W-135, lot number UE110AA, administered subcutaneously in the left arm at 1:05 PM on 01/22/04. Approximately five hours later, at 6:00 PM, the patient developed redness, itching and swelling at the injection site. The patient was treated initially with Benadryl and was also given intravenous and or antibiotics, as well as Percocet for pain. Reportedly the patient recovered from this experience. The patient had previously experienced injection site redness at the age of 42 years following the receipt of Menomune, TD and Pnemo.									Y	01/22/2004	01/22/2004	0		UNK	UNK	Nicoderm Patch Stage 1	NONE	The patient had previously experienced redness at injection site at the age of 42 years following the receipt of Menomune, TD and Pneumo.		200400389	1						1	Injection site erythema; Injection site swelling; Pruritus	FLU3~PARKDALE PHARMACEUTICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|MEN~SANOFI PASTEUR~UE110AA~2~SC~LA~MENINGOCOCCAL (MENOMUNE)~1	USA		Influenza
0232626	01/21/2005	TN	36.0	36		F	01/21/2005	01/18/2005 - 5:20pm Onset of severe dizziness and lightheadedness extreme fatigue. 01/19/2005 - Upon awakening - severe pain at posterior mid-thoracic with movement - felt like pleurisy dizziness continued. 01/12/2005 - Symptoms worsened with myalgia of neck, headache.  Saw physician received Tamiflu.				Y					N	01/18/2005	01/18/2005	0	WBC at low end.	PVT	PVT	Allegra D	NONE	NONE			1						1	Dizziness; Fatigue; Headache; Myalgia; Pain; Pleurisy	FLU3~SANOFI PASTEUR~01561AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0232627	01/21/2005	TN	39.0	38		M	01/21/2005	01/18/2005 - Fatigue 01/19/2005 - Upon awakening severe dizziness unable to drive fatigue, headache. 01/20/2005 - Malaise, myalgia ankles, fever, continued dizziness headache.									N	01/18/2005	01/19/2005	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Dizziness; Fatigue; Headache; Malaise; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1561AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232628	01/21/2005	TN	27.0	27		F	01/21/2005	01/18/2005 - Extreme dizziness onset and upper respiratory congestion. 01/19/2005 - Upon awakening myalgia neck, shoulders, continued respiratory congestion, temperature 100.4 - symptoms continued all day. 01/20/2005 - Increase in myalgia to lower body, headache, continued respiratory congestion - saw physician received Tamiflu.				Y					N	01/18/2005	01/18/2005	0	WBC - low	PVT	PVT	NONE	NONE	NONE			1						1	Dizziness; Myalgia; Pyrexia; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~U1561AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0232629	01/21/2005		37.0			F	01/03/2005	Anxiety, itching, watering eyes, agitation, anaphylaxis, chest pain, congestion, nasal, dyspnea.									U		12/02/2004			UNK	UNK			No.  Contraindications to vaccination noted at administration.			1						1	Agitation; Anaphylactic reaction; Anxiety; Chest pain; Dyspnoea; Lacrimation increased; Nasal congestion; Pruritus	FLU3~SANOFI PASTEUR~U1461DA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232630	01/21/2005	CA	19.0	18		M	12/07/2004	Patient inadvertently received an extra dose of pneumococcal vaccine, denies any symptoms.									Y	12/07/2004	12/07/2004	0	N/A	MIL	MIL	NONE	NONE	PCN, Sulfa			1						1	Medication error; Overdose	FLU3~SANOFI PASTEUR~U1555AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~A026BA~UNK~IM~LA~HEP A + HEP B (TWINRIX)~1|MEN~SANOFI PASTEUR~UE301AA~UNK~SC~LA~MENINGOCOCCAL (MENOMUNE)~1|MMR~MERCK & CO. INC.~9104510~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0232631	01/21/2005	MA	1.72	1	.7	F	01/11/2005	Fever, erythema, induration and swelling on right thigh, redness and induration 3 x 2.5 CM.									Y	01/07/2005	01/08/2005	1		PVT	PUB	NONE	Fever	NONE			1						1	Erythema; Injection site induration; Pyrexia; Swelling	DTAP~CONNAUGHT LABORATORIES~U1342DA~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1519AB~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~CONNAUGHT LABORATORIES~UA834AA~4~IM~RL~HIB (ACTHIB)~1	USA		Influenza
0232632	01/21/2005	MS	70.0	69		F	01/14/2005	Red rash and itching covering entire back, along incision from back surgery and wrist, and under breast.									Y	01/03/2005	01/03/2005	0		PUB	OTH						1						1	Erythema; Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0232633	01/21/2005	CO	44.0	44		M	01/10/2005	Rash on arms and legs - not itchy, mild irritation.  No prior reactions to shots.  No treatment given.									Y	01/08/2005	01/09/2005	1	Not done.	MIL	MIL	NONE					1						1	Rash	FLUN3~MEDIMMUNE VACCINES, INC.~5003357AA~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0232635	01/21/2005	SC	73.0	72		M	01/21/2005	Complained of redness, and swelling of left arm with mild pain for duration of 2 days following administration of pneumonia shot.  To MD on  10-22-04.  Diagnosis of cellulitis. Prescription given for Augmentin XR times 5 days.  Treated with warm compresses.				Y					Y	10/19/2004	10/21/2004	2	NONE	UNK	UNK	HCTZ, Metroprololtrate, Simbastatin, Irbesartan, Chlortheniramine maleate, Plavix, Aciphex	NONE	Aortic valve repair with 3 bypasses, skin cancer, prostate removal after cancer diagnosis		SC0452	1						1	Cellulitis; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U1499AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~06857~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0232637	01/21/2005	FL	81.0	80		F	01/21/2005	Received Pnuemovax Vaccine in her right arm at approx 11 am on Jan 12,2005. At approx. 3PM had swelling  and pain around vaccine site with erythema encompassing entire upper arm. Site was hot and endurated. Applied cold packs to site. Did not seek medical attention. Reported reaction on 1/20/05. Still has some redness around site, complains of itching around site and upper arm. Advised pt. to contact her primary physician for follow up.									Y	01/12/2005	01/12/2005	0	NA	UNK	UNK	Propranolol, clonazepam, Sinemet		Allergic to Pennicillin, Sulpha Drugs, Codeine.			1						1	Injection site erythema; Injection site hypersensitivity; Injection site induration; Injection site pain; Injection site swelling; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U1528AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0371P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0232638	01/21/2005	SC	73.0	73		F	01/21/2005	Complained of swelling and knot at shot site on right arm tmes 4 days.  Good ROM.  No MD visit.									Y	10/19/2004	10/20/2004	1	NONE	UNK	UNK	Advair inhaler; Synthroid	NONE	Leaking heart valve; hypothyroidism		SC0453	1						1	Injection site mass; Injection site swelling	FLU3~SANOFI PASTEUR~U1499AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232639	01/21/2005	SC	68.0	67		F	01/21/2005	On 10/20/04 Client complained of painful, red, swollen right arm after PPV23 immunization given on 10/19/04.  Good ROM and blanching.  Saw MD on 10/21/04.  Rx: Ibuprofen; Benedryl.  Tx: cold compresses				Y					Y	10/19/2004	10/20/2004	1	none	UNK	UNK	NONE	NONe	No medical conditions. Allergic to penicillin.		SC0454	1						1	Injection site discolouration; Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1499AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0685N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0232640	01/21/2005	VA	0.82	0	.8	F	01/21/2005	She had been in for her 9mo well exam on 12/28/04 and was to receive her 6mo immunizations.  She received the Pediarix, Prevnar, Hib, and the Fluzone for influenza. That evening, at approximately 2100, she was taken to the local ED for a possible seizure and a fever up to 103.  With her evaluation at the ED she had a urine sample obtained by catheter that showed her to have a urinary tract infection.  It was unclear as to whether she had a primary seizure, or a seizure from the fever from the shots or a seizure from a febrile urinary tract infection.   She was fine on the day recheck in the office on 12/30/04.				Y					Y	12/28/2004	12/28/2004	0	CBC, BMP, Blood culture, cath urine with culture, CXR.	UNK	UNK	NONE	NO	NO, BUT THERE IS A FAMILY HISTORY OF FEBRILE SEIZURES IN A YOUNGER BROTHER.			1						1	Convulsion; Pyrexia; Urinary tract infection	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~21A004BA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1383AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE396AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~57561F~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0232641	01/21/2005	MA	62.0	61		F	01/21/2005	1 hr. after receiving vaccine, developed itching on left wrist, no hives; developed swelling in left hand that continued to the following day.									Y	01/20/2005	01/20/2005	0		UNK	UNK	none	None; Did state that had a similiar reaction the past summer (2004) after  receiving an oral antibiotics.	Allergy to PCN			1						1	Oedema peripheral; Pruritus	FLU3~SANOFI PASTEUR~U1555AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232643	01/21/2005	IL	0.69	0	.7	M	01/21/2005	Fever up to 103F for 4 days following the Influenza vaccine.									Y	12/22/2004	12/23/2004	1	None	UNK	UNK						1						1	Pyrexia	FLU3~SANOFI PASTEUR~U1528AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232646	01/21/2005	MI	23.0			F		This is a serious post marketed study case from a physician who reports a pt required hospitalization for viral pericarditis after receiving FluMist vaccination. The reporter assessed the events to be possibly related to FluMist study vaccine. On 10Dec04, a 23 year old female received FluMist or Placebo and on 27Dec04 developed acute pericarditis with moderate pericardial effusion while participant in an investigator initiated randomized, double-blinded, placebo-controlled, experimental, epidemiological study. The pt developed trouble breathing on 10Dec04 some time after receiving FluMist. She indicated this to be mild on her daily post vaccination report form from 10Dec04 and moderate on 16Dec04 and 17Dec04. The pt reported feeling chest pain 16Dec04 and constant pressure as well as couldn't take a deep breath. She also had a sinus cold. The pt attributed her chest pain to the cold and her 5 cigarette per day smoking. The pt developed a fever of 100.5 degrees F on 25Dec04. On 26Dec04, the pt had 5-6 bouts of diarrhea. The pt went to urgent care and was subsequently referred to the ER. She presented to the ER on 27Dec04 and was hospitalized with general malaise for the past week that had progressed into substernal chest pressure resulting in difficulty breathing. On the same day she presented to the ER, she also had 5-6 bouts of runny stool as well as low grade fever of 100.5 degree range at home every night over an unspecified date. The hospital discharge summary relates a diagnosis of pericardial effusion, possibly secondary to viral pericarditis. Pulmonary embolism was ruled out due to lack of contraceptive use, no recent travel, no calf symptoms, and the insidious onset of symptoms. The pt's elevated white blood cell count, erythrocyte sedimentation rate, and C-reactive protein indicated an inflammatory process. The discharge summary states the pt's clinical presentation is most consistent with acute viral pericarditis. Chest x-ray indicated an enlarged heart border. A bedside echocardiogram showed results consistent with a moderate sized pericardial effusion but no frank tamponade. Cardiac consultation decided to defer pigtail drainage of effusion in light of the pt's stable clinical findings. A repeat echocardiogram on day of discharge continued to demonstrate a moderate effusion but no change in appearance from 27Dec04. The pt was discharged on 29Dec04 with instructions to continue around the clock NSAIDS for two weeks. As of 04Jan05, the pt claims she feels better but that mild physical exertion such as climbing stairs still causes her to feel chest pressure. The pt will follow up with general medicine on 07Jan05 and cardiology on 27Jan05. Additional information has been requested in terms of infectious agent.					Y				Y	12/10/2004	12/10/2004	0	12/27/04: 2D Echocardiogram: Moderate-sized pericardial effusion but no frank tamponade. Compression of the right atrium. Chest X-ray: Low lung volumes with vascular crowding. Bibasilar airspace opacities, likely representing atelectasis. Limited evaluation of lateral view secondary to poor inspiratory effort. EKG: Sinus tachycardia with no acute ischemic changes. 12/29/04: 2D Echocardiogram: ejection fraction of 65%, otherwise normal values and function. Moderate pericardial effusion with systolic compression of the right atrium free wall. Exaggerated respiratory compression of the left ventricle. No hemodynamic compromise. Stable to slightly improved compared with the ECHO on 12/27/04.	OTH	OTH	NONE		Smokes 5 cigarettes per day.		MEDI0002726	1						1	Cardiomegaly; Chest discomfort; Chest pain; Diarrhoea; Dyspnoea; Laboratory test abnormal; Malaise; Pericardial effusion; Pericarditis; Pyrexia; Sinus congestion	FLUN3~MEDIMMUNE VACCINES, INC.~500335P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0232647	01/21/2005	NY	16.0	15		F		This is a serious case from a physician involving pulmonary vascular congestion: unlabelled. The reporter causality is not provided. A 15 year old female, who received FluMist on 22Oct04, experienced difficulty breathing, wheezing and coughing on 30Oct04. The pt was seen at the physician's office where she was given Xopenex (levalbuterol) nebulizer treatments and Decadron (dexamethasone) IM injection. Despite the treatments, the pt went into severe respiratory distress and was brought to the ER and was subsequently admitted on 30Oct04 with a principal diagnosis upon admission of asthma. During the four day hospitalization, the pt received nebulizer treatments, steroids and chest physiotherapy. Chest x-ray revealed pulmonary vascular congestion and cardiomegaly. Peak flow rates were monitored and had an average of 360. The pt was discharged home on 02Nov04 in stable condition with discharge medications of albuterol MDI, prednisone, Seroquel (quetiapine). The pt's clinical outcome is unk. The reporter did not assess relationship between events and FluMist vaccination. Information from missing data report states 04/22/05 per reporter at physician's office, they do not have a record of the Flumist lot number.					Y	4			U	10/22/2004	10/30/2004	8	Chest x-ray pulmonary vascular congestion, cardiomegaly, oxygen saturation 94% during hospitalization. Peak flow average 360.	PVT	OTH	NONE		Attention deficit and hyperactivity disorder (ADHD), Depression/Bipolar disorder, father is a smoker.		MEDI0002727	1						1	Asthma; Cardiomegaly; Cough; Dyspnoea; Hypoxia; Pulmonary congestion; Respiratory distress; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0232653	01/21/2005	CA	1.53	1	.5	F	01/21/2005	Febrile seizure the night after 18 months vaccines.				Y					Y	01/20/2005	01/20/2005	0		PVT	OTH	Albuterol nebulizer Pulmacort nebulizer	Mild URI with RAD	RAD			1						1	Febrile convulsion	DTAP~SANOFI PASTEUR~C2103AA~4~IM~~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1467AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1189~3~IM~~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0419P~UNK~IM~~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C74405E~4~IM~~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0232654	01/21/2005	WA	1.0			M	01/22/2005	Patient with erythopapular scattered blanching rash, changing now with raised central small whitish papule on erythema base on same. Mostly on trunk, abdomen, face and scalp. Also with upper respiratory infection symptoms and right otitis media. Appears like a varicella rash a mild case.									N				CBC	PVT	PUB						1						1	Dermatitis bullous; Erythema; Otitis media; Rash maculo-papular; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~U1470AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE253AC~UNK~IM~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0960N~UNK~SC~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|VARCEL~MERCK & CO. INC.~0595P~UNK~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0232753	01/24/2005	NY	62.0	62		F	01/24/2005	PT Received Vaccination on Tues October 12th, On Saturday Oct 16 PT complained of feeling sick, Pt was admitted on Monday. PT was diagnosed with Pneumonia, and Septic Shock. Pt was in ARDS and never recovered. Pt was under other doctors care for bronchitis. PT deceased on 12/24/2004. Discharge summary from hospital received which revealed pt had multiple respiratory allergies, heavy smoker had SOB, fever, back & chest pain.  CXR consistent w/multilobar pneumonia & COPD.	Y	12/24/2004	Y	Y	Y	66	Y		N	10/12/2004	10/14/2004	2		UNK	UNK	Levaquin	Bronchitis Allergies				1						1	Dyspnoea; Lung disorder; Malaise; Pneumonia; Pyrexia; Respiratory distress; Sepsis	FLU3~SANOFI PASTEUR~U1442AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0232754	01/24/2005	GA	23.0	23		M	01/24/2005	PT administered Flu-Mist at 1050 and started c/o of loss of perpherial vision at 1100.  Pt examined by doctor and Field of Vision test performed.  Both test were WNL.  Pt c/o of minor photophobia and HA.  Neuro exam was normal.  After 30 min., symptoms decreased expect for HA.				Y					Y	01/24/2005	01/24/2005	0	Visual Acuity - Normal	MIL	MIL	None	None	None			1						1	Photophobia; Visual field defect	FLUN3~MEDIMMUNE VACCINES, INC.~500354P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0232755	01/24/2005	VA	51.0	51		M	01/24/2005	1) Severe muscle cramping/pain in right shoulder/neck area 24 hours after injection.  Shot injected in right arm. 2) Severe gastrointestinal cramping and diarrhea 60 hours after injection. 3) Burning chest & dry cough 7 days from injection 4) 100 degree fever 9 days after injection w/muscle & joint aches and pains.									N	01/13/2005	01/14/2005	1	None	UNK	UNK	None	None	Diverticulitis			1						1	Abdominal pain; Arthralgia; Cough; Diarrhoea; Muscle spasms; Myalgia; Neck pain; Pyrexia; Shoulder pain	FLU3~SANOFI PASTEUR~U1559BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232757	01/24/2005	NY	82.0	81		F	01/24/2005	Within 2 days of vaccination, blisters appeared on the face, neck, front torso, legs.  Pain in the back of the right leg with burning sensation, currently spreading to the buttock area.  Sores being treated with ointment prescribed my Dermatologist, and tylenol for the pain in the leg...INSUFFICIENT.  Diagnosed by 3 physicians as chicken pox & possible shingles.				Y					N	01/07/2005	01/09/2005	2	NOTE:Flu vaccine NOT SURE which one. Unsure of the required data required for the questions below.  Please contact physician for info.	UNK	UNK		None No exposure to other children/adults.	Demerol allergy Aortic valve replaced 2/04			1						1	Blister; Herpes zoster; Pain; Viral infection	FLU3~PFIZER\WYETH~~2~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0232759	01/24/2005	UT	1.4	1	.4	M	01/24/2005	THE LESION IS .25 CM IN SIZE. SHAPE IS ROUND. VESICLE ARRANGEMENT IS GROUPED, AND HAS A FOCAL DISTRIBUTION.  ADDITIONAL SURROUNDING ERYTHEMA, INDURATION, AND WARMTH, NOT SPREADING.  START BACTROBAN NOW, BENADRYL IF NEEDED, DURACEF IF WORSENS, AFFECTED SITE OUTLINED.									U	01/14/2005	01/21/2005	7		UNK	UNK		CONSIPATION, ECZEMA ON FACE				1						1	Injection site erythema; Injection site induration; Injection site warmth; Skin ulcer	DTAPH~SANOFI PASTEUR~UE417AA~4~IM~LL~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~U1451AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A57562B~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0439P~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0232772	01/24/2005	VT	52.0	51		M	01/21/2005	From follow up information received on 1/14/05 the seriousness of this case was upgraded from non-serious to serious, as based upon medical judgement. From initial information received on 11/1/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 51 year old male patient received a dose of FLUZONE vaccine, lot number U106888, administered in the right deltoid on 10/17/03. Four days later, on 10/21/04, the patient developed lingering shoulder pain at the right deltoid site. The patient has seen an orthopedic shoulder specialist and has been through physical therapy. He also used non-steroidal anti-inflammatories with no beneficial effect. The orthopedic shoulder specialist thought that the patient may have developed some sort of myositis. Patient's pre-existing medical conditions include high cholesterol. He has no known allergies. He did not have any illnesses at the time of vaccination. Concomitant medications at the time of vaccination included ASA and Zocor. The patient previously received four doses of influenza vaccine with no reactions reported. Reportedly, the discomfort, although it has waxed and waned somewhat, has not diminished significantly over the last several months. The patient has not recovered from these events. From additional information received on 1/14/05, from a physician, it was reported that the patient received a 0.5ml dose of FLUZONE, administered IM in the right deltoid. Reportedly, the patient had no illnesses at the time of vaccination. An MRI of the patient's right shoulder was completed on 10/22/04 due to right shoulder pain. The MRI showed marked AC joint hypertrophy, labrum intact and minor glenoid changes. Per the reporter, the patient's shoulder pain was somewhat improved as of the patient's office visit on 12/23/04. The physician stated that he does not consider the adverse events to be a significant or permanent disability, but it was a cause of significant pain. Reportedly, the patient retained strength, range of motion and function of his shoulder. Contact information for the patient's orthopedic specialist was provided. The adverse event coding for injection site pain was upgraded to shoulder pain.				Y					N	10/17/2003	10/21/2003	4	The patient had an MRI completed in October of 2004. MRI results were not provided. From additional information received on 1/14/05, a radiology report was provided. The patient had an MRI of his right shoulder on 10/22/04 due to shoulder pain. The MRI showed marked AC joint hypertrophy with some secondary bone edema, especially at the distal clavicle. Some focal lucency was also noted at the site. The changes might have been due to osteoarthritis, but an erosive arthropathy could not be completely excluded and correlation with the patient's history and involvement of other joints was recommended. There was impingement on the superior aspect of the supraspinatus, but no rotator cuff tear was seen. Other focal bony abnormality was not noted. There were changes of chronic impingement on the posterior aspect of the superolateral humerus. The physician also thought it relevant to know if the patient has a history of prior dislocation as there was some bony irregularity at the posteroinferior aspect of the glenoid labrum also seen with slight abnormality in bone signal change on the gradient images. The physician's impression was marked AC joint hypertrophy, labrum intact and minor glenoid changes as described.	PVT	PVT	ASA; Zocor		Patient's pre-existing medical conditions include high cholesterol. He has no known allergies. He had no illnesses at the time of vaccination. The patient previously received four doses of influenza vaccine with no reactions reported.		200403589	1						1	Discomfort; Hypertrophy; Injection site pain; Laboratory test abnormal; Myositis; Shoulder pain	FLU3~SANOFI PASTEUR~U106888~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0232776	01/24/2005	MA	84.0	83		F	01/04/2005	Received flu shot on left deltoid on 11/10/2004 at senior center, flu clinic organized by Board of Health. Information based on pt; she felt pain and couldn't pick up the left arm 2 hours after the shot. She experienced numbness down to the wrist. She was seen by Dr the same day. She continued to experience pain and difficult of movement on the left arm. She is under PT until now.				Y					N	11/10/2004	11/10/2004	0		PUB	PUB		NONE	UNK			1						1	Hypoaesthesia; Hypokinesia; Injection site pain	FLU3~SANOFI PASTEUR~U1560AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0232777	01/24/2005	TX	54.0	53		F	01/07/2005	Left deltoid area/hyperemia 60mm x 30mm									U	01/06/2005	01/07/2005	1		PVT	PVT	Mobic, Avandia, Darvocet, MVT/Folic Acid	DM II, Hyperlipidemia, O/A	Fatty liver, high LFT's, + ANA			1						1	Hyperaemia	FLU3~SANOFI PASTEUR~U1568AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232778	01/24/2005	TX	0.64	0	.6	M	12/23/2004	Right leg pain (weakness). Information from medical records states myalgia. msv					Y				Y	12/14/2004	12/14/2004	0		PVT	PUB					TX04097	1						1	Asthenia; Injection site pain; Myalgia	FLU3~SANOFI PASTEUR~U1486AA~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A74400L~3~~LL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0232779	01/24/2005	OR	77.0	77		F	01/07/2005	Client described next day injection site, redened and swollen.  Slightly itchy.  Seen in Clinic 12/23 Arm at injection site remgins redened to about 4 cms.  Bruised at injection site and edges of redness.									Y	12/16/2004	12/17/2004	1	NONE.	PUB	PUB	Baby ASA	Pernicious Anemia			OR200501	1						1	Contusion; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U1556AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232780	01/24/2005	CA	1.0			M	01/14/2005	MMR, Comvax (ABV/HIB), Varicella, Flu shots given on 12/17/04. Had Febrile Sz on 12/19/2004 associated with fever.				Y					Y					PVT	UNK		NONE	NONE			1						1	Febrile convulsion; Pyrexia	FLU3~SANOFI PASTEUR~U1501AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0391P~3~~LL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~1299N~1~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0198P~1~~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0232781	01/24/2005	WI	72.0	71		F	01/20/2005	C/O flu like symptoms next day, fatigue, nausea, and HA x 4days. Reports HA went away for couple days and then returned. HA reported as constant, everyday all day. Reports high BP also as a new diagnosis, scheduled for tests on coratid arteries.									U	11/10/2004	11/11/2004	1		PUB	PUB	Phenobarbital	NONE	Seizures			1						1	Fatigue; Headache; Nausea	FLU3~SANOFI PASTEUR~U1504AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232782	01/24/2005	OH	65.0	65		F	01/21/2005	Chills, fever, weakness, dizziness, nausea, couldn't sleep, too cold.									Y	01/11/2005	01/11/2005	0		PUB	UNK						1						1	Asthenia; Chills; Dizziness; Feeling cold; Insomnia; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0232783	01/24/2005	NH	4.0	4		M	01/24/2005	1 needle used Left shoulder - 5 cm red area. - warm to touch. - swollen, firm, tender.  01/21/2005 Keflex 2 tsp po 250 mg/5cc 2x/day x10 days.				Y					N	01/20/2005	01/21/2005	1	NONE	PVT	PUB	NONE	NONE	Obese child Allergy to amoxicillin.		NH0501	1						1	Erythema; Feeling hot; Swelling; Tenderness	DTAP~SMITHKLINE BEECHAM~639A2~5~~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1483AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1213~4~~RA~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0232795	01/24/2005	NM	0.54	0	.5	F	01/11/2005	1 cm knot and redness left anterior thigh 3 mm knot right thigh									Y	01/06/2005	01/10/2005	4		PVT	PUB					NM012005	1						1	Erythema; Injection site mass	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A008BA~3~IM~RA~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1484AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0495P~3~IM~LA~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~A74405K~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0232813	01/25/2005	KY	59.0	58		M	01/13/2005	About 1 hour after receiving vaccine, felt light headed, & prickly sensation on neck, back and chest.  Felt like heart rate increased.  No visible hives.  Took 50mg PO Benadryl at home.  Relief obtained in about 1 hour.  did not seek medical help, even though advised to do so.									Y	01/13/2005	01/13/2005	0		UNK	UNK	Paxil 25mg qd, vitamins, Saw Palmetts	none	PCN, Erythromycin, Bee Stings, Poison Oak & Ivy		KY2005006	1						1	Dizziness; Heart rate increased; Paraesthesia	FLU3~SANOFI PASTEUR~U1394DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232821	01/25/2005	FL	1.17	1	.2	M	01/13/2005	Fever 104, altered consciousness, dyspnea, chills on 1/9/05. Vaccines given 1/6/05. Blood, CSF, Urine cultures, IV fluids, IV Rocephin one dose in ER. Follow up 02/03/2005: Diagnosis: Fever no focus, R/o Bacteremia, altered mental status. Physician's letter requesting financial help.					Y	1			Y	01/06/2005	01/09/2005	3	CBC, LP, U/A, CMP, Urine, Blood, CSF culture, CXR	PVT	PVT		NONE	NONE			1						1	Chills; Depressed level of consciousness; Dyspnoea; Pyrexia	DTAPH~SANOFI PASTEUR~U1290AA~3~IM~RL~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~U1470AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1215N~2~IM~LL~HEP B (RECOMBIVAX HB)~1|IPV~SANOFI PASTEUR~X1240~3~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|VARCEL~MERCK & CO. INC.~0654P~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0232822	01/25/2005	NC	6.0	6		M	11/01/2004	Dizziness, redness and rash around injection site, now developing a constant blinking process of the eyes. Medical Records received on 2/02/2005 states appetite poor. Information from Discharge summary states hyponatremia. msv									Y	10/25/2004	10/27/2004	2	CMP, CBC nl, oxcarbazepine level ok Information from discharge summary states abnormal lab tests, H&H depressed. msv	PUB	PUB	Trilepental 1 PO Bid (8ml, Lamital 150mg BID, Dextermine 10mg qd	NONE	Asthma, seizure disorder, ADHD mild mental retardation Information from discharge summary states Glaucoma, gout, anemia, macrocytic & aortic stenosis. msv		NC05003	1						1	Anaemia macrocytic; Anorexia; Dizziness; Erythema; Hyponatraemia; Injection site rash; Laboratory test abnormal; Muscle twitching	FLU3~SANOFI PASTEUR~1478AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232823	01/25/2005	SD	4.0	3		F	12/20/2004	On 12/7/04 09:15 child's mother telephoned office stating pt had started throwing up, coughing and running mild temp. She asked if it could be from the flu shot she received on 11/29/04. In my absence, secretary advised her to take pt to Dr. Pt is special needs child with multiple disabilities. I was unable to make contact with parents until 12/14/04. Mom related that child was spitting a little before she saw Dr in				Y					Y	11/29/2004	12/07/2004	8		PUB	PUB	Med for seizures	NONE	CID cytomegaly infectious disorder, milk soy protein		SD04030	1						1	Cough; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1558AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0232824	01/25/2005	ID	43.0	43		F	12/07/2004	Welts, urticaria rash starting under arms 2 hours after flu mist given. It spread to inner thighs, hairline and wrists the same evening. The next day rash spread to breasts. Visited doctor 12/3/04 and placed on Benadryl and Zertec. Still has rash on breasts as of 12/7/04 symmetrical rashes.									Y	12/02/2004	12/02/2004	0	NONE	PUB	PVT	Prior to FluMist, cortisone shot for shoulder	NONE	Bursitis R shoulder		ID04062	1						1	Rash; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500339P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0232825	01/25/2005	ID	48.0	47		M	12/17/2004	Administered FluMist 20 minutes past administration client had itchy palms and tingling fingers bilaterally with a flushed face and a R sided headache. He was given diphenhydryl PO and acetaminophen, 1hr later symptoms resolved.									Y	12/17/2004	12/17/2004	0		PUB	PVT	NONE	NONE	Seasonal allergies trees, grasses, no med needed		ID04065	1						1	Flushing; Headache; Paraesthesia; Pruritus	FLUN3~MEDIMMUNE VACCINES, INC.~500339P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABA015AA~1~IM~LA~HEP A + HEP B (TWINRIX)~1	USA		Influenza
0232826	01/25/2005	ID	0.53	0	.5	F	12/23/2004	Rectal T 102.6. Erythema, swelling, warmth, and pain around injection site. Irritable began 8-10 hrs after injection. Seen about 24 hrs. Left lateral thigh				Y					U	12/22/2004	12/23/2004	1		PVT	PUB	NONE	NONE	NONE		ID04067	1						1	Erythema; Feeling hot; Injection site pain; Irritability; Oedema	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A014AA~3~~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1464AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A83578C~3~~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0232884	01/25/2005	MI	32.0	32		F	01/25/2005	Painful arm. Denies redness, swelling.  Has tried warm/cold compresses-no help.									U	01/04/2005	01/04/2005	0		UNK	UNK		Denies				1						1	Pain	FLU3~SANOFI PASTEUR~U1569AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232887	01/25/2005	MA	1.27	1	.3	M	01/25/2005	On 1/22/05, the patient suffered a witnessed, 45 minute seizure.  At medical center, he was found to have temperature 101.7, in status epilepticus.  He was treated with valium and phenobarbital.  He was intubated and transferred to another medical center.  LP and head CT were negative. Discharge summary states dehydration, thrush, hypoxia. msv Information received from medical records states apnea, vomiting, flushed as symptoms.msv				Y	Y	3			U	01/12/2005	01/22/2005	10	Head CT, lumbar puncture all normal Discharge summary states abnormal lab values. msv	UNK	UNK	None	None	None Medical records states otitis as proor hx. msv			1						1	Apnoea; Candidiasis; Convulsion; Dehydration; Flushing; Hypoxia; Laboratory test abnormal; Pyrexia; Status epilepticus; Vomiting	FLU3~SANOFI PASTEUR~U1555AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1050N~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A74400F~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0232888	01/25/2005	CA	74.0	73		F	12/13/2004	Soreness at injection site 4 hours after shot given.  Moderate to severe pain in right arm with intermittant numbness and tingling to fingers right hand x 3 wks.  Also complain of pain right leg.  MD to rule out possible Guillain-Barre. Refer to neurologist who suspects pinched nerve. Information from medical records states cervical radiculopathy.msv									U	11/23/2004	11/23/2004	0		UNK	UNK			COPD Information received from medical records states brain infarct. msv			1						1	Hypoaesthesia; Injection site pain; Neck pain; Nerve compression; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U1519AB~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232889	01/25/2005	NY	17.0	17		M	01/25/2005	1.FEVER AND ABDOMINAL PAIN WITHIN 18 HOURS- MOTRIN, CHARCOAL CAPSULE 2.PAIN FROM RIGHT SHOULDER TO ELBOW AND ARMPIT AND BACK RADIATING FROM CHEST WITHIN 24 HOURS 3.WHEEZING, LIGHT HEADEDNESS, NAUSEA, LOOSE BOWELS WITHIN 24 HOURS- ALBUTEROL INHALER, REST 4. CHEST PAIN, IRREGULAR HEARTBEAT, ATRIAL FIBRILLATION-WITHIN 48 HOURS- WENT TO ER- TOLD TO REST				Y					N	01/21/2005	01/22/2005	1	EKG, XRAYS, BLOOD TESTS	UNK	UNK	BABY ASPIRIN	NONE	PENICILLIN, AMPICILLIN, AUGMENTIN, LORABID, ZITHROMAX, DOXICYCLIN SLEEP APNEA	MUSCLE SPASTICITY~DTP (no brand name)~1~0.20~In Patient		1						1	Abdominal pain; Atrial fibrillation; Chest pain; Diarrhoea; Dizziness; Heart rate irregular; Nausea; Pyrexia; Shoulder pain; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0232890	01/25/2005	WA	45.0	45		M	01/25/2005	I received the the FluMist on 01,25,05 at 0800 in the morrning. That evening 9 hours later the back of my neck felt like some one hit it with a bat. Stiffness, muscle pain, glands in neck on fire, A # 8 on the pain level. Still sore the next day. Self treated with heat, 800ml Tylenol and 500ml Motrin.									Y	01/25/2005	01/25/2005	0		MIL	MIL		N/A	N/A			1						1	Musculoskeletal stiffness; Myalgia; Neck pain	FLUN3~MEDIMMUNE VACCINES, INC.~50035~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0232896	01/25/2005	PA	57.0	56		F	01/25/2005	At work on 12/31/04, raspy voice. Then tongue swelling then starting to go down. Could not breathe. Recurred in ER. ER doctor gave epinephrine. Started having hives over my entire body. Came home from hospital. 2 more ER visits. Doctoring with family doctor. I still have hives. I'm not working. Follow up 03/01/05: The patient had an acute reaction the day after vaccination; angioedema, shortness of breath, dysphagia and anxiety. She wa treated with Benadryl, Epinepherin, Tagament and Solumedrol. An allergist diagnosed as systemic anaphylaxis to an unknown substance. Patient had no known allergies prior to vaccination. Discharge summarty information states drooling. Medical Record received on 3/08/2005 states dysphagia.			Y	Y	Y	2			N	12/30/2004	12/31/2004	1	High/elevated white blood cells.	PVT	PVT	Nadolol	NONE	Medical Records received on 3/08/2005 states hypertension.			1						1	Anaphylactic reaction; Angioneurotic oedema; Anxiety; Drooling; Dysphagia; Dysphonia; Dyspnoea; Tongue oedema; Urticaria; White blood cell count increased	FLU3~SANOFI PASTEUR~U1549AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0232897	01/25/2005	IL	34.0	33		F	01/25/2005	States today after receiving shot yesterday that her arm is red, hot to touch, and itches.  Notes some swelling on left side next to site.									U	01/24/2005	01/25/2005	1		PUB	PVT						1						1	Erythema; Feeling hot; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U1419AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232909	01/26/2005	FL	46.0	46		F	12/14/2004	Guillain Barre from flu shot. Per follow up report received on 07/19/2005:  Patient has numbness and tingling feet.  Let and arm muscle weakness, 90%. Information from medical records states ataxia, parethesis, low back pain.. Information from Discharge summary states decreased reflexes, msv Per follow up report-Still have no reflexes-fatigue, depression, spasms, numbness and patients feeling is not correct. Cannot wear flip flops they fall off.			Y		Y	20			N	09/26/2003			MRI, Blood work, Spinal tap, Nerve conduction study. Medical records state abnormal EMG, abnormal lab tests, CSF abnormal msv	PVT	OTH		Well	NONE Information from medical records states hypothroid, depression, hypertension. msv Discharge summary states herniation of T spine disc. msv			1						1	Back pain; CSF test abnormal; Coordination abnormal; Guillain-Barre syndrome; Hypoaesthesia; Hyporeflexia; Laboratory test abnormal; Muscular weakness; Paraesthesia	FLU3~SANOFI PASTEUR~U1095AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0232911	01/26/2005	WI	24.0	23		F	01/21/2005	Influenza vaccine given 01/14/05 without immediate symptoms. 5 days later, on 01/19/05 client started having symptoms. 01/19/05 and 01/20/05, had slight sore throat, headache and slight nasal congestion. No chest congestion or fever. This AM 1/21/05, client experienced nausea and vomiting, without fever.									Y	01/14/2005	01/19/2005	5		PUB	UNK	NONE	NONE	NKA			1						1	Headache; Nasal congestion; Nausea; Pharyngolaryngeal pain; Vomiting	FLU3~SANOFI PASTEUR~U557AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232912	01/26/2005	AZ	48.0	47		F	01/12/2005	12/29/04 Flu-Mist administer. On 12/31/04, patient had body aches and temperature of 101 degrees. On 01/03/05, patient  had cough, congestion, sore throat and fatigue. On 01/04/05, patients temperature was 101 degrees and on 01/06/05 it was down to 98.7 degrees.									Y	12/29/2004	12/31/2004	2	N/A	PVT	PVT		N/A	Environmental allergies, allergic to Penicillin and Erythromycin.			1						1	Cough; Nasal congestion; Pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~50035IP~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0232913	01/26/2005	WA	1.11	1	.1	M	01/22/2005	Patient with erythema papular scattered blanching rash, changing now with raised central small whitish papule on erythematous base. Mostly on trunk abdomen, face and scalp. Also with URI symptoms and bilateral otitis media. Appears like varicella rash, mild case. Follow up 02/04/05: Patient also has fever.									N	01/12/2005	01/17/2005	5	CBC	PVT	PUB						1						1	Dermatitis bullous; Otitis media; Pyrexia; Rash papular; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~U1470AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE253AC~4~IM~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0960N~1~SC~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|VARCEL~MERCK & CO. INC.~0595P~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0232914	01/26/2005	PA	73.0	72		U	12/23/2004	Received vaccine at 13:30, went home and by 19:30 hives were present on the abdomen, extremities, back and neck. Saw physician on 12/21/04 at 13:30, had taken Benadryl until seen by MD. Hives reoccurred that evening, 12/21/04 and patient again started Benadryl and Tylenol. No further follow up recommended, hives resolved by 12/22/04.									Y	12/20/2004	12/20/2004	0	NONE	PUB	OTH	See attached sheet	NONE	All ASA, Tylenol with codeine. Open heart surgery with valve replacement, CHF, Goiter, MA			1						1	Urticaria	FLU3~SANOFI PASTEUR~I1521AB~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232917	01/26/2005	PA	66.0	65		F	12/14/2004	12/10/2004 Pt reported reddened, blotchy, swollen, hot area at site vaccine placed and further down her arm. Seen by physician 12/10/04. Pt reports on 12/14/04 her physician told her it looked like an infection and gave her antibiotics. By 12/14/04, pt reports no redness or swelling or pain.				Y					Y	12/08/2004	12/10/2004	2		PUB	PVT	UNK	UNK	UNK			1						1	Feeling hot; Injection site erythema; Injection site infection; Injection site oedema; Rash macular	FLU3~SANOFI PASTEUR~U1439AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0691P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0232918	01/26/2005	CA	0.63	0	.6	M	01/20/2005	Mother complained of reaction after immunization given on 01/18/2005 with 35 x 34 induration, swelling, redness to right lateral thigh, mother states patient's reaction looks better since earlier AM.  Child playful with no symptoms of pain or discomfort, no fever no limitations of right leg mobility.  Instructions given to mother if reaction worsens to return or seek medical care.									Y	01/18/2005	01/20/2005	2	NONE	PUB	PUB		Cold Symptoms	NONE			1						1	Erythema; Injection site induration; Swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~610A2~3~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1484AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0366N~UNK~IM~RL~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~A79659C~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0232919	01/26/2005	WA		55		F	01/18/2005	10-12cm red, hot, raised, tender Rxn to flu shot now down to 5cm bruised/ darkened area still slightly swollen and tender.									Y	01/14/2005	01/14/2005	0		PUB	UNK		NONE	Sulfa, PCN			1						1	Contusion; Feeling hot; Injection site erythema; Injection site oedema; Injection site swelling; Skin discolouration; Tenderness	FLU3~SANOFI PASTEUR~U1579AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232920	01/26/2005	GA	1.03	1	.0	M	01/14/2005	Vaccine caused chicken pox as diagnosed by Dr. Temp of 102.8, small blister like bumps all over body.				Y					U	01/04/2005	01/13/2005	9		PUB	OTH	Singulair	NONE	NONE			1						1	Blister; Pyrexia; Viral infection	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~1~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~1~~~VARICELLA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0232927	01/26/2005	FL	4.0	4		M	01/21/2005	DTAP administered to right upper arm 01/18/2005 with right arm edema, tenderness, warm to touch area approx 10 cm by 10 cm. Keflex 25 mg/kg 4.5 cc PO BID for 10 days started. Back in office 01/21/2005 with improvement.									Y	01/18/2005	01/19/2005	1		PUB	PUB						1						1	Feeling hot; Oedema; Tenderness	DTAP~SMITHKLINE BEECHAM~AC1419009~5~IM~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~X1213~4~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0416P~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0232948	01/26/2005	SC	1.2	1	.2	M	01/26/2005	MON CALLED NURSE ON CALL (1/25/05 @ 2119) AND STATED THAT CHILD HAD RASH ON BACK AND LEGS.  ADVISED TO GIVE 1/2 TSP BENADRYL. IF WORSENS, GO TO ER.  MOM TOOK CHILD TO ER AND CHILD WAS GIVEN A DOSE OF STEROID.  I SPOKE WITH MOM THIS AM, RASH IS NOW GONE AND CHILD IS DOING WELL.				Y					Y	01/25/2005	01/25/2005	0	NONE	UNK	UNK	DIMETAPP AND ACCUHIST	NASAL CONGESTION WITH NO FEVER	NONE			1						1	Rash	DTAP~GLAXOSMITHKLINE BIOLOGICALS~634A2~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1466AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0410P~2~IM~LL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0044P~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0826P~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0232960	01/26/2005	NJ	66.0	65		M	01/26/2005	Right arm cellulitis.									U	01/24/2005	01/24/2005	0		PUB	OTH		NONE				1						1	Cellulitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~0986N~2~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0232961	01/26/2005	MT	1.75	1	.7	F	01/26/2005	Saturday 01/22/05, patient was taken to ER. She had a temp of 104.4, glands were swollen, rash on her neck and chest, and her groin area had some swelling. She had measles shot on 01/11/05. ER doctor performed a strep test, influenza and UA to rule out a bladder infection. All were negative. ER doctor also performed a white blood cell count. No treatment administered. Motrin and Tylenol was recommended to give for fever. 01/25/05, patient has a low grade fever and is fatigued.				Y					N	01/11/2005	01/21/2005	10	White blood count was normal, Strep test was negative, influenza test was negative and UA was normal. No signs of UTI or bladder infection.	MIL	PVT		NONE	Allergies to some dairy products and eczema.			1						1	Abdominal distension; Fatigue; Lymphadenopathy; Pyrexia; Rash	FLU3~PARKDALE PHARMACEUTICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|MEA~MERCK & CO. INC.~0906N~1~SC~RL~MEASLES (ATTENUVAX)~1	USA	Emergency room visit	Influenza
0232974	01/27/2005	AL	48.0	47		M	01/25/2005	From initial information received on 1/24/05 from a healthcare professional regarding an adverse event occurring, it was reported that a 47 year old male patient received a dose of FLUZONE, lot number U1579AA, administered IM in the left deltoid on 1/21/05. Twelve hours later, the patient developed generalized itching and hives as well as chest tightness and shortness of breath. The patient treated himself with Benadryl and went to the emergency room. His pulse oximetry in the emergency room was 89%. He was treated with steroids and discharged home. Per the reporter, the patient received influenza vaccine annually with no reactions reported. Reportedly, the patient recovered from these events. (OMIC)				Y					Y	01/21/2005	01/21/2005	0	Pulse oximetry in the emergency room was at 89%.	UNK	UNK			It is unknown whether the patient has any pre-existing medical conditions, birth defects, or allergies. Per the reporter, the patient had no illnesses at the time of vaccination.		200500217	1						1	Chest discomfort; Dyspnoea; Injection site hypersensitivity; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1579AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0232975	01/27/2005	NC	70.0	69		M	01/27/2005	Patient complained of redness and muscle aching in area where shot was given and down forearm, right arm.									Y	01/24/2005	01/26/2005	2		PVT	PVT		Cold/Cough	NKDA		NC05013	1						1	Injection site erythema; Myalgia	FLU3~SANOFI PASTEUR~1503AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0490P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0232988	01/27/2005	PA	37.0	37		M	01/21/2005	Pain , erythema swelling of right upper arm which started after injection									U	01/19/2005	01/20/2005	1		PVT	UNK						1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1442AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0709P~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0232989	01/27/2005	NY	51.0	50		M	01/19/2005	Lightheaded, unable to tolerate bright lights , not able to swallow.									Y	11/16/2004	11/16/2004	0		MIL	MIL			Allergy to penicillin			1						1	Dizziness; Dysphagia; Visual disturbance	FLU3~SANOFI PASTEUR~u1478AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0232990	01/27/2005	MA	76.0	76		M		1/18/05 this is to report an apparent reaction to flu vaccination received 12/02/2004 at city hall, after that date left town and still away. Approx 5-6 days after the shot, I developed very severe pains in upper extremities, in forearm and tricep muscles, joints, and esp shoulder joints on both sides. Never had anything like that before and was tennis player, exerciser to present. Was not able to lift arms above shoulder level for weeks. Still some tenderness, but gradually cleared after 3 weeks went to orthopedic surgeon for exam. He first thought had rotator cuff injury, but pain was both shoulders, worse left side of injection. He took x-ray which showed normal joint. Then he diagnosed bursitis which recommended ibuprofen or cortisone injection. I took ibu 6 days then stopped in order to avoid medications when possible. Gradual improvement since, and will soon resume gym workouts. Only possible other factor, is that I had general malaise for one week before injection low grade, that I attributed to some kind of infection, probably throat. I'm ending this to be of assistance to your evaluations; will be interested if others had any problems - thank you.				Y					U	12/02/2004	12/03/2004	1		PUB	UNK						1						1	Arthralgia; Bursitis; Fatigue; Movement disorder; Myalgia	FLU3~SANOFI PASTEUR~U1555AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0232991	01/27/2005	SC	25.0	24		F	01/05/2005	itchy rash trunk and UR.									Y	01/04/2005	01/04/2005	0		MIL	MIL			history of mild reaction with flu injection			1						1	Pruritus; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500357P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0232992	01/27/2005	PA	50.0	50		M	01/19/2005	Slight paresthesia of fingertips 12/30 Aching and weakness in legs 01/01 Increase weakness in legs and hospitalized 01/06  01/28/05 Pt states he had hx of a headache and lethargy early in December.  Wife and son had 'stomach bug' (gas, bloating, diarrhea) in mid December,'but I didn't get it', and back pain on 12/17 which went down his leg 'like sciatica'. Pt continues with out pt therapyand finds fatigue most difficult part of recovery.  02/16/05 Discharge summary received for 1/6-1/13/2005 FINAL DX: Guillain-Barre syndrome & spinal headache, improved.  Time line is FluMist vax on 12/29/04, developed leg pain, weakness and numbness starting 01/01/05. He was evaluated in PMP on 01/06/05 and admitted w suspected onset of GBS.  Exam revealed deceased reflexes and increased CSF protein. Was evaluated and treated by neurologist given 4 courses of plasmapheresis, symptoms improved and was discharged home 01/13/05 w/outpatient rehab & Neuro f/u.					Y	7			N	12/29/2004	01/01/2005	3	Cerebrospinal fluid protein - 69 (H).	PVT	PVT	Trazadone		Information from discharge summary states anxiety as preexisting S/S.			1						1	CSF test abnormal; Guillain-Barre syndrome; Headache; Muscular weakness; Pain; Paraesthesia	FLUN3~MEDIMMUNE VACCINES, INC.~500338P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0232993	01/27/2005	SC	48.0	47		F	01/25/2005	Reddened, warm, raised area at injection site.  Complainted of  burnig and itching at injection site.									Y	01/24/2005	01/24/2005	0	NONE	PUB	PVT	NONE		Denies			1						1	Feeling hot; Injection site erythema; Pruritus; Skin burning sensation	FLU3~SANOFI PASTEUR~U1560AB~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233014	01/27/2005	MI	47.0	46		F	01/27/2005	Soreness began day after injection and progressively worsened.  Unable to lift arm above head now.									N	01/05/2005	01/06/2005	1		UNK	UNK	No	No	Codeine			1						1	Hypokinesia; Myalgia; Pain	FLU3~SANOFI PASTEUR~U1569AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233015	01/27/2005	MI	52.0	51		F	01/27/2005	Soreness started day of shot.  Arm sore when reaching for seat-belt or putting on coat.									N	01/05/2005	01/05/2005	0		UNK	UNK	Prozac, prilosec	Jan. 15th diagnosed with bronchitis and pneumonia	Bronchitis; allergy to tetracycline			1						1	Myalgia	FLU3~SANOFI PASTEUR~U1569AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233017	01/27/2005	MI	27.0	27		F	01/27/2005	Arm became sore night of vaccination.  Stayed sore for about 3 weeks.  Felt worse at night and first thing in morning.  Had a massage yesterday and arm is somewhat better today.									N	01/05/2005	01/05/2005	0		UNK	UNK	None	No	None			1						1	Pain	FLU3~SANOFI PASTEUR~U1569AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233020	01/27/2005	NC	58.0	57		M	01/27/2005	11/17/2004: sore arm, fever T100.4F, Tylenol given. 11/18/2004: redness, swelling near/around injection site, diphenhydramine, ranitidine, compresses given. Keflex started for possible infection. 11/20/04: reaction resolved. (reaction involved right arm)									Y	11/16/2004	11/18/2004	2		MIL	PUB	NONE	Angina	CAD, HTN			1						1	Injection site erythema; Injection site infection; Injection site oedema; Injection site pain; Injection site reaction; Pyrexia	FLU3~SANOFI PASTEUR~U1478AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0233021	01/27/2005	FL	1.61	1	.6	M		Round, erythematous lesion 7x5cm  on right thigh, mildly warm to touch non tender. Blanches with pressure.									U	01/24/2005	01/26/2005	2	NONE	PVT	PVT		NONE	NONE			1						1	Erythema; Feeling hot; Injection site discolouration; Skin ulcer; Tenderness	DTAP~SANOFI PASTEUR~C2103AA~4~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1240~3~IM~LL~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0233025	01/27/2005	WA	38.0	38		M	01/27/2005	Starting the day after his flu shot on 1/19/05, he started getting a mysterious outbreak of pinpoint sized red hives up his arms on the inside (especially the left one where he received the flu shot), and around the neck area.  He stated is started Thursday AM, 1/20/05, with a sore arm that started feeling 'tingly', mainly in his left arm and traveling up his neck and going to his right arm as well.  He stated the hives come and go, and have lasted until today, 1/27/05.  Last night on 1/26/05, he stated his left arm and upper chest and neck began to itch, and a cluster of what looked like small, flat mosquito bite-like hives appeared up his left arm.  They lasted for approximately 2 hours and went away; he did not take any OTC or prescription meds to treat the hives.  He stated his hives last from approximately 1/2 day to all day long.				Y					N	01/19/2005	01/20/2005	1	None	UNK	UNK	Zolof, trazadone, clonazepam	None	None			1						1	Erythema; Paraesthesia; Urticaria	FLU3~SANOFI PASTEUR~U1496AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0233029	01/27/2005	LA	1.01	1	.0	F	01/19/2005	Had immunization on 01/10/2005 11:30AM. Saw in Dr office 1/13/05 with c/o running temp up to 103.6 since. 1/10/05. Diagnosed on 1/13/05 with tonsillitis and RAD and placed on antibiotic. (3 reaction to immunizations)				Y					Y	01/10/2005	01/10/2005	0	NONE	PVT	PUB	Zyrtec, Amoxil, Pediarix, Xopenex and Pulmicort Nolia	Rales and RAD, rhinorrhea x 1 week	RAD and GE Reflux			1						1	Asthma; Pyrexia; Similar reaction on previous exposure to drug; Tonsillitis	FLU3~SANOFI PASTEUR~U1468AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0041P~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A79659C~4~~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0649P~1~~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0232424	01/28/2005	FL	74.0	73		F	01/28/2005	12/14/04-Body aches, increased without relief after Tylenol.  Admitted 12/28/04.  Discharge & readmit- 1/17/05.  Coded ICU 1/19/05.  Still in hospital as of 1/28/05.  Report given by son. Information from discharge summaries (2) states urinary tract infection, hip sprain, bruising; Short of breath, hypoxia, edema or legs.  From Medical records Lethergy, pneumonia, sweating, cough, atrial fibrullation, pleural effusion, malnutrition, decubitis, artelectasis.				Y	Y	24	Y		N	12/10/2004	12/14/2004	4	Numerous-no access to pt. records FromMedical records, Lab test abnormal, hypoalbumia, metabolic alkalosis; hyponatremia, hyperglycemia.	UNK	UNK	Theophylline, Prednisone, Lasix, Cardizem, Phosimex, Combivent, Albuterol per son.	Hx. chronic asthma per son.	Asthma per son. From discharge summary diabetes, chronic obstructive lung disease, hypertension; from medical records steroid dependence, atrial tachycardia, hyperlipedemia, cva, tobacco use, fractures of ribs/ vertabra.		BOI0501	1						2	Asthenia; Bacterial infection; Decreased appetite; Drug ineffective; Fatigue; Influenza; Anorexia; Atelectasis; Atrial fibrillation; Chest pain; Contusion; Cough; Dyspnoea; Hyperglycaemia; Hyperhidrosis; Hypoalbuminaemia; Hyponatraemia; Laboratory test abnormal; Lethargy; Metabolic alkalosis; Myalgia; Oedema peripheral; Pain; Pleural effusion; Pneumonia; Skin ulcer; Urinary tract infection	FLU3~SANOFI PASTEUR~U1552AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1552AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0233034	01/28/2005	IL	79.0	78		F	01/26/2005	From initial information received on 1/24/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 78 year old female patient received a dose of FLUZONE, lot number U1410BA, administered IM in an unspecified site on 10/11/04. Reportedly, within two weeks, the patient developed fatigue. She was diagnosed with a viral illness and hospitalized. Subsequently, the patient developed thoracic pain, spine pain, optic neuritis, and ataxia. Reportedly, the ataxia had worsened and the patient developed paralysis of bilateral lower extremities. The patient was diagnosed with transverse myelitis and sent for rehabilitation treatment, where she also developed a fever. The patient was once again hospitalized. A lumbar puncture was performed and was negative. The patient's family then transferred the patient to another facility. The physician's office was later informed that the patient expired in January of 2005. The patient's pre-existing medical conditions included high blood pressure, high cholesterol, and diabetes. Concomitant medications include Diovan, Glyburide, and unspecified cholesterol medications at the time of vaccination. Discharge Summary received on 2/17/2005 states apnea.	Y	01/01/2005			Y				N	10/11/2004	10/25/2004	14	Lumbar puncture was negative.	PVT	PVT	Diovan; Glyburide; Cholesterol medications		The patient's pre-existing medical conditions include high blood pressure, elevated cholesterol, and diabetes. She denied any illnesses at the time of vaccination.		200500215	1						1	Apnoea; Coordination abnormal; Fatigue; Myelitis transverse; Optic neuritis; Pain; Paralysis; Pyrexia; Viral infection	FLU3~SANOFI PASTEUR~U1410BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0233039	01/28/2005	MA	54.0	53		F	01/15/2005	Patient stated following vaccine, on her way home she began to have hot feeling in the back of her neck. She also had a funny feeling in her head. She drove herself to the ER, were she was monitored for 2 hours. No medication was given, no IV fluids and no reaction at injection site.				Y					Y	12/29/2004	12/29/2004	0	N/A	PVT	PUB	N/A	Fullness due to allergies	Inhalant allergies, recurrent sinusitis.			1						1	Feeling hot; Head discomfort	FLU3~SANOFI PASTEUR~U1519AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0233047	01/28/2005	NJ	85.0	84		M	01/28/2005	0/20/04-PATIENT DROVE TO DRS OFFICE FOR CHECKUP. WAS FINE EXCEPT FOR A 100.3 FEVER...PATIENT VERY HASTILY GIVEN FLU SHOT OVER MY PROTESTATIONS...(DR ACTUALLY CLAIMED THAT THE SHOT WAS AMONG THOSE HE HAD 'SAVED' FROM MARCH OF 2004 AND MY DAD WAS 'LUCKY' TO BE GETTING A SHOT AT ALL, SINCE WE WERE ABOUT TO RUN OUT(!)....NAUSEA DEVELOPED LATE ON OCT 22, FOLLOWED BY GENERAL WEAKNESS, INCREASED FEVER AND SUDDEN DEMENTIA BY MORNING OF 0.25.2004...RUSHED TO EMERGENCY ROOM AT THAT POINT...FEVER SPIKES TO 104, SEIZURES BEGIN AND THE PATIENT IS 'COMPLETELY UNRESPONSIVE' IN ICU FOR 19 DAYS..INFECTIOUS DISEASE TEAM BEGINS TESTS AND PATIENT IS DIAGNOSED WITH ENCEPHALITIS....FEVER RETURNS TO NORMAL, PATIENT TAKEN OUT OF ICU, BUT WITHOUT ANY MOTOR SKILLS, OR MEMORY OF ANYTHING..INCLUDING SELF, HIS WIFE OF 60 YEARS OR ME...PATIENT PLACED IN HOSPITAL ROOM ON FEEDING TUBE AND THEN TRANSFERRED TO CONVALESCENT HOME MID NOVEMBER...PATIENT OFF FEEDING TUBE BUT NOT AMBULATORY AND WITH TOTAL MEMORY LOSS AS OF TODAY (1/28/05).  Follow up: Non responsiveness, fever, kidney failure, pneumonia, seizure (many) pt was placed on do not resusitate list Apr 10, 2005. From Discharge summary, nausea, weadness, dementia. msv			Y	Y	Y		Y	Y	N	10/20/2004	10/22/2004	2	Medical Records received on 2/9/2005 states hyperlipidemia.	UNK	UNK		FEVER OF 100.3. Medical Records received on 2/9/2005 states fell, hit head laceration.	HEART BYPASSES, PACEMAKER, DIABETES(NON-INSULIN DEPENDENT), NO KNOWN ALLERGIES. Medical Records received on 2/9/2005 states knee replacement, CAD, hearing decreased and vision decreased.			1						1	Asthenia; Coma; Convulsion; Dementia; Encephalitis; Hyperlipidaemia; Hypokinesia; Memory impairment; Nausea; Pneumonia; Pyrexia; Renal failure; Akathisia; Amnesia; Asthenia; Confusional state; Congenital brain damage; Encephalitis; Loss of consciousness; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~U1446AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0233048	01/28/2005	MI	63.0	63		F	01/28/2005	After receiving the shot arm became very sore in afternoon.  Arm better but continues to be sore.  Hurts when sleep on same side.  Hurts in joint.									N	01/05/2005	01/05/2005	0		UNK	UNK	Periostat	No	None			1						1	Arthralgia; Pain	FLU3~SANOFI PASTEUR~U1569AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233050	01/28/2005	PA	3.0	2	1	M	01/26/2005	TZ developed a low grade fever up to 100.5 Degrees evening of the shot.  Temp. went up to 103 Degrees in 24 hours on 01/20/2005 (48 hours later), at about 5PM he had a brief convulsion.  Then was confirmed by the ER - He was being treated for sinobronchitis w/Amoxil (01/11/2005 - 01/25/2005) - No further treatment.				Y					Y	01/18/2005	01/20/2005	2	WBC = 21.8 ; Electrolytes = normal From Discharge summary 08/17/05 leukocytosis	PVT	PVT	Amoxil from 01/11/2005 - 01/26/2005	Upper respiratory and bronchitis	Premature; reactive airway disease.  From medical records 08/17/05 Bone disease, fatigue and GI disease			1						1	Convulsion; Leukocytosis; Pyrexia	FLU3~SANOFI PASTEUR~U1403AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0233052	01/28/2005	MA	38.0	37		F	01/28/2005	Dizziness, light-headed, mild chest tightness, no difficulty breathing, VSS-WNL  2 doses Benadryl, followed by epinephrine.  She refused to go to hospital or MD.									Y	01/26/2005	01/26/2005	0		UNK	UNK			Allergic to Latex - latex free gloves and syringes used.			1						1	Chest discomfort; Dizziness	FLU3~SANOFI PASTEUR~U1479AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233059	01/28/2005	CA	4.0	4		F	01/25/2005	Presents at clinic: adverse reaction to vaccine L arm c/o pain - hot to touch, pain c mobility, erythema below deltoid-->elbow, tense swelling noted, hard to touch.  Benadryl given.  Prednisone started.  No previous reactions to vaccines.  Improvement noted 1/26/2005				Y					Y	01/22/2005	01/24/2005	2		UNK	UNK	None	None - 4 year well-child visit	Premature @ birth		AZ0501	1						1	Erythema; Hypokinesia; Injection site induration; Injection site swelling; Injection site warmth; Pain	DTAP~GLAXOSMITHKLINE BIOLOGICALS~620A9~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1555AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1189~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1185N~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0233074	01/31/2005	MD	24.0	24		F	01/31/2005	Pt noted metallic taste at 1 minute. Lasted a couple minutes. Noted rash on forearms at about 30 minutes. Fine papular, erythematous. Lasted until now which is 4 days. Still present. Pruritic. No hives, SOB, Fever, Chills, myalgias. No relief with Benadryl. History is from the patient. Pt not seen until today.				Y					U	01/27/2004	01/27/2004	0	none	MIL	MIL	Prenatal vitamin	none	none			1						1	Dysgeusia; Pruritus; Rash erythematous; Rash papular	FLU3~SANOFI PASTEUR~U1557AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0233075	01/31/2005	FL	50.0	50		M	01/31/2005	Fever (101), cold sweats, malaise, diarrhea, coryza, cough, headache.				Y					Y	01/25/2005			none	MIL	MIL		none	none			1						1	Cough; Diarrhoea; Headache; Hyperhidrosis; Malaise; Pyrexia; Rhinitis	FLUN3~MEDIMMUNE VACCINES, INC.~500356P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0233078	01/31/2005	NJ	67.0	66		F	12/29/2004	Took the flu vaccine on 12/1/04 at 10:00 AM; went back to work. Had a slight soreness in the left arm where vaccine was given. Same day at 3:00 PM, had a static noise in right ear. Lost hearing in this ear. Later had vomiting and dizziness. Follow up 03/07/05: Patient was seen in the emergency room on 12/04/04. Chief complaint was vertigo and hearing loss. Patient reported felt a little dizzy and heard staticky sound in right ear. By next am pt had severe vertigo with nausea, requiring compazine and Bonine, and noted severe hearing loss in right ear. Over the next 48 hours vertigo is lessening but hearing loss has not improved in right ear. No further tinnitus reported. Patient denies aural fullness. Patient received flu shot this week, just prior to onset of symptoms. Upon ears were found to be clear with normal appearing tympanic membrane. Eyes: no nystagmus vertical or horizontal gaze. CT of head showed not Focal Lesions and Labs normal. Impression: Acute right Labyrinthitis, prob viral, affecting both cochlear and vestibular nerves. ER summary states labyrinthitis. msv				Y				Y	N	12/01/2004	12/01/2004	0	Had MRI/MRA/CT Scan of brain. Had 2 hearing tests. Follow up 03/07/05 CT Head and Labs Normal.  Summary sttes lab test abnormal. msv	OTH	OTH			High blood pressure-mitral valve prolapse Information received from medical records states torticullis, hypercholesteremia.			1						1	Dizziness; Hearing impaired; Injection site pain; Laboratory test abnormal; Labyrinthitis; Tinnitus; Vomiting	FLU3~SANOFI PASTEUR~U1579AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0233081	01/31/2005	IL	43.0	42		F	01/24/2005	History of increasing pain of arm from deltoid to elbow and in armpit to breast level. No discoloration or lumps. Has pain and tenderness to touch and is afebrile. Using sports cream on left arm and taking acetaminophen. Pain described as worse when raising left arm. Had first flu shot 5 years ago via air gun with similar symptoms, therefore she wanted to file report. Pain described as worse now. (4 days later)									U	01/20/2005	01/21/2005	1		PUB	PVT	Tylenol Sinus, Prevacid and Depo Provera	Nasal congestion and sinus pressure	Allergic to Penicillin and Acid Reflux	Knot under arm and Pain~Influenza (Seasonal) (no brand name)~1~37.00~In Patient		1						1	Pain	FLU3~SANOFI PASTEUR~U1531AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233082	01/31/2005	MO	1.51	1	.5	F	01/27/2005	Patient received DTaP and Flu shot (1st 1/2 dose) to left thigh on 01/25/05. Both immunizations in same leg D/T rash on right thigh. Reaction site is 7.5cm x 6cm, red, raised and warm to touch. No other symptoms noted. Mom called today to schedule appointment for this afternoon.				Y					U	01/25/2005	01/26/2005	1		PVT	PUB	NONE	Eczema	NONE			1						1	Injection site warmth; Rash erythematous	DTAP~SANOFI PASTEUR~C1996AA~4~~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1553AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0233083	01/31/2005	MD	68.0	67		F	01/27/2005	Severe pain in left hip, could not walk, was taken to ER in a wheel chair, was out of work for a week. Had an Epidural, pain lasted for 2 weeks before normal walk. Pt reported: I am a hospital employee. I have never  had a flu vaccine before. Since I am in contact with the public at the hospital my superiors insisted I have the vaccine. Since receiving the vaccine I have also had Bronchitis, which I have never had before. I never got a cold bad enough for me to miss work. Several other people at the hospital had similar problems.				Y					Y	11/18/2004	11/19/2004	1	MRI, X-ray	PUB	UNK		NONE	NONE			1						1	Arthralgia; Bronchitis; Difficulty in walking; Hypokinesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0233084	01/31/2005	TX	75.0	75		F	01/25/2005	Rash back of neck, both arms. No rash at site of injections, itching of rash.									Y	01/20/2005	01/20/2005	0		PUB	UNK		NONE	NONE			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U1518AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~AVENTIS PASTEUR~U1282AA~2~IM~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0233085	01/31/2005	NC	63.0	62		F	01/26/2005	Severe pain at site, angioedema, severe diarrhea, dyspnea with wheeze, all within 4 hrs of injection				Y					N	01/25/2005	01/25/2005	0		PVT	PVT	Nexium, Combivant	NONE	CORD, Lumbar disc dz			1						1	Angioneurotic oedema; Diarrhoea; Dyspnoea; Injection site pain; Wheezing	FLU3~SANOFI PASTEUR~U1552AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0579P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0233086	01/31/2005	TX	4.0	4		M		One day after being immunized with the flu vaccine the right arm broke out with a rash. By the afternoon the rash spread to back and stomach. Referred to his doctor. Physician stated no more flu vaccine ever. The rash redness subsided by 1/8/05. C/o itching until the 8th also.				Y					Y	01/05/2005				PUB	PUB		NONE			HOU0502	1						1	Injection site rash; Pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~41460AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0233087	01/31/2005	PA	54.0	54		F	01/19/2005	Within 3 hours of Flu vaccine, felt nauseous, had a headache, dizziness and chills, generally did not feel right. Slept for 3 hours after 6 hours had passed since Flu vaccine.									Y	01/17/2005	01/17/2005	0		PVT	PVT		NONE	NONE			1						1	Chills; Dizziness; Feeling abnormal; Headache; Nausea; Somnolence	FLU3~SANOFI PASTEUR~U1443AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233119	02/01/2005		79.0	78		F	08/22/2003	A report was received form a health care professional in 07/22/2002, concerning a 77 year old female patient who experienced a large red firm area at injection site after receiving Fluvirin on 10/09/2001. On 10/09/2001, the patient received Fluvirin, after which the patient experienced a red firm area at injection sit. The patient recovered in  approximately 3 days without treatment or intervention. At the time of reporting no further information was available. Update: A follow up report was received form a health care professional on 10/02/2002 concerning the 77 year old female patient who experienced redness, warmth and swelling  at injection site which lasted for 3-5 days. The patient did not need medical intervention and fully recovered. The reporter has assessed the relationship of Fluvirin to the event as probable. Update 10/14/2002: A follow up report was received on 10/14/2002 confirmed that the patient had received Fluvirin.									Y	10/09/2002	10/09/2002	0	Echography- negative, Radiography- negative	UNK	UNK	Celebrex-200mg (2 in 1D) Niacin- 500mg (500mg 1 in 1 D) Depakote-250mg (250mg BID) Glucophage-2000mg PO Glucotrol-20mg (10mg BID) Zyprexa-5mg (5mg 1in 1D) PO qhs Prozac-(90mg in 1 week) PO  Calcium- 500mg (500mg 1 in 1D) ASA-325mg  (1 in 1D				PJP200200418	1						1	Injection site erythema; Injection site mass; Injection site oedema; Injection site warmth	FLU3~EVANS VACCINES~E04861KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233120	02/01/2005					F	08/22/2003	A report was received from a health care professional on 09/23/2002, concerning a female patient in her 20's who experienced injection site soreness after receiving Fluvirin on 09/19/2002. On 09/19/2002 the patient received Fluvirin and experienced injection site soreness shortly after. The soreness worsened over the next couple of days, spreading throughout the entire arm. On 09/23/2003 the patient still experienced arm soreness. At the time of the report the patient had not recovered. The reporter has assessed the relationship of study medication to the event as possible and the health professional is concerned that the event may have been associated with this particular batch.									U	10/19/2002	10/19/2002	0		UNK	UNK					PJP200200464	1						1	Injection site pain; Pain	FLU3~EVANS VACCINES~E34682HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233121	02/01/2005					F	08/22/2003	A report was received from a health care professional on 09/23/2002, concerning a female patient in her 40's who experienced injection site soreness after receiving Fluvirin on 09/19/2002. On 09/19/2002 the patient received Fluvirin and experienced injection site soreness shortly after. The soreness worsened over the next couple of days, spreading thoughout the entire arm. On 09/23 the patient still experienced arm soreness. At the time of the report the patient had not recovered. The reporter has assessed the relationship of study medication to the event as possible and the health care professional is concerned that the event may have been associated with this particular batch.									U	09/19/2002	09/19/2002	0		UNK	UNK					PJP200200465	1						1	Injection site pain	FLU3~EVANS VACCINES~E34682HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233122	02/01/2005					F	08/22/2003	A report was received from a health care professional on 09/23/2002, concerning a female patient in her 60's who experienced injection site soreness after receiving Fluvirin on 09/19/2002. On 09/19/2002, the patient received Fluvirin and experienced injection site soreness shortly after. The soreness worsened over the next couple of days spreading throughout the entire arm. On 09/23 the patient still experienced arm soreness. AT the time of the report the patient had still not recovered. The reporter has assessed the relationship of study medication to the event as possible and the helath care professional is concerned that the event may have been associated to the batch.									U	09/19/2002	09/19/2002	0		UNK	UNK					PJP200200466	1						1	Injection site pain	FLU3~EVANS VACCINES~E34682HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233123	02/01/2005		36.0			M	08/22/2003	A report was received from a consumer on 10/03/2002 concerning a 36 year old male vaccinee who experienced raised patches on arm. abdomen, back and leg one day after receiving Fluvirin on 09/25/2002. The vaccinee had no known drug allergies nor egg allergy and was not taking any concomitant medications. The vaccinee had a past history of tinea versicolor, the vaccinee did not experience any reaction at previous flu vaccine(brand unspecified) administrations. On 09/25/2002 the vaccinee received Fluvirin intramuscularly in his upper arm. The following day the vaccinee experienced some small, non itchy raised patches on his arm. By the weekend, he had similar raised patches on his abdomen, back, and leg/ The vaccinee was not sure if the reaction was secondary to the Fluvirin, or if his past skin condition was flaring up. The rash he experienced was different than he had experienced due to the tinea versicolor. At the time of reporting the patches on his arm had almost all recovered, but the rash on his abdomen, back and leg were still persisting.									U	09/25/2002	09/25/2002	0		UNK	UNK			Tinea versicolor		PJP200200472	1						1	Exfoliative rash; Rash erythematous	FLU3~EVANS VACCINES~E34662HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233124	02/01/2005		80.0	79		F	08/22/2003	A report was received form a health care professional on 10/07/2002, concerning a 79 year old female who inadvertently received Fluvirin subcutaneously on 03/10/2002. On 03/10/2002 the patient inadvertently received one dose of Fluvirin subcutaneously. At the time of reporting the patient did not experience any effects from the event. The reporter has assessed the relationship of study medication to the event as unclassifiable.									U	03/10/2002	03/10/2002	0		UNK	UNK					PJP200200475	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233125	02/01/2005		29.0	29		F	08/22/2003	A report was received from a health care professional on 10/04/2002, concerning a 29 year old female vaccinee who inadvertently received an overdose Fluvirin on 04/10/2002. On 04/10/2002 the vaccinee inadvertently received 5ml of Fluvirin. The vaccinee has received influenza vaccination (brand unspecified) for the 2000-2001 and 2001-2002 formulations without any adverse effects. At the time of reporting the vaccinee did not experience any effects from the event. There was insufficient information to determine the reporters causality assessment. Update1. 11/14/2002: The vaccinee experienced pain, throbbing, heat and swelling on the 10/04/2002. The events resolved on 10/04/2002. The reporter has assessed the relationship of the vaccine to the events as probable.									Y	10/04/2002	10/04/2002	0		UNK	UNK					PJP200200476	1						1	Injection site oedema; Injection site pain; Injection site warmth; Overdose	FLU3~EVANS VACCINES~E34722HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233126	02/01/2005					U	08/23/2003	A report was recieved from a health care profesional on 10/03/2002, concerning a child vaccinee less than 4 years old who experienced a medication error after receiving Fluvirin on an unknown date. The vacccinee experienced no adverse events at the time of the reporet. At the time of administration, the health care professional were not aware that Fluvirin was no approved for vaccinees less thanm 4 years of age. There was unsufficient information to determine the reoporters causeality assessment.									Y					UNK	UNK					PJP200200480	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233127	02/01/2005		12.0			F	08/22/2003	A reporte was received from a patient advocate on 10/10/2002, concerning a 12 year old female vaccinee who received Fluvirin on 10/10/2002. The vaccinee who is autistic was also receiving 400mg TID Seroquel and 5mg TID ayestin. On 10/10/2002, the vaccinee recieved 0.5ml of Fluvirin via the intramuscular route. Most of the vaccine accidentally spilled out onto the arm of the vaccinee. The vacciee had not experienced any adverse events at the time of the report.									Y	10/10/2002	10/10/2002	0		UNK	UNK	Seroquel-400mg PO  Ayestin-5mg PO		Autism		PJP200200483	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233128	02/01/2005		31.0	31		F	08/22/2003	A report was received from a health care professional on 10/11/2002, concerning a female vaccinee in her 30's  who experienced a rash and an injection site reaction after receiving Fluvirin on 10/09/2002. On 10/09/2002, the vaccinee received a 0.5ml dose of Fluvirin. After an unknown period of time the vaccinee developed a rash, a soreness and a knot at the injection site. The vaccinee had not recovered at the time of the report. The reporter has assessed the relationship of the vaccine to the events as probable. Update1. 01/20/2003: A follow up report was received from a health care professioanl concerning a 31 year old female vaccinee who experienced hives after receiving Fluvirin intramuscularly in the left deltoid. The hives resolfved 1 day after vaccination on 10/10/2002/ The vaccinee had no previous exposure to Fluvirin,the vaccinee was treated with unspecified antihistamines. The reporter has assessed the relationship of the vaccine to the hives as probable.									Y	10/09/2002	10/09/2002	0		UNK	UNK					PJP200200484	1						1	Injection site mass; Injection site pain; Rash; Urticaria	FLU3~EVANS VACCINES~E3547HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233129	02/01/2005		1.47	1	.5	F	08/02/2003	A report was received from a health care professional on 10/11/02, concerning a 17 month old female vaccinee who received 0.5ml of Fluvirin on 10/09/02. The vaccinee had experienced no adverse events at the time of the report but was being monitored. The reporter has assessed the relationship of Fluvirin to the event as unclassifiable.									U	10/09/2002				UNK	UNK	Concomitant Drug Not Used		No risk factors reported.		PJP200200485	1						1	Medication error	FLU3~EVANS VACCINES~E33922HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233130	02/01/2005		58.0	57		F	08/22/2003	A report was received from a health care professional on 10/11/2002, concerning a 57 year old female patient who inadvertently received Fluvirin subcutaneously into her arm on 10/07/2002. The patient had experienced no adverse events at the time of the report. The reporter has assessed the relationship of Fluvirin to the event as unclassifiable. Update (1) 11/22/02: The patient experienced slight soreness. The event resolved on an unknown date.									U	10/07/2002				UNK	UNK	Concomitant Drug Not Used		No risk factors reported.		PJP200200491	1						1	Medication error; Pain	FLU3~EVANS VACCINES~E35452HA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233131	02/01/2005		0.59	0	.6	M	08/22/2003	A report received from a health care professional on 10/10/2002, concerning a 7 month old male vaccinee who inadvertently received Fluvirin on 10/09/02. On 10/09/02, the vaccinee was inadvertently administered 0.25 ml of Fluvirin, intramuscularly. The nurse was unaware of Fluvirin's indication and no adverse event was reported on the initial report. There was insufficient information to determine the reporter's causality assessment. A follow up report was  received on 11/29/02 indicating that the vaccinee was born 5 weeks premature and spent 4 weeks in neonatal ICU.									U	10/09/2002				UNK	UNK	Amoxicillin, DTCP and IPU		No risk factors reported.		PJP200200493	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233132	02/01/2005		48.0			M	08/22/2003	A report was received from a health professional on 10/11/02, concerning a 48 year old female vaccinee who experienced an injection site reaction approximately 30 minutes after receiving Fluvirin on 07/10/02. He experienced a red, hot, itchy injection site swelling. There was insufficient information to determine the reporter's causality assessment. 5 other vaccinees vaccinated at the same time with the same batch had the same reaction. See PJP200200500, PHP200200501, PJP20020052, PJP20020053, and PJP200200504. Update (1) 12/10/02: A report was received from a health care professional, the  injection site reaction had resolved at the time of the report.									U	07/10/2002				UNK	UNK	Concomitant Drugs Not Reported.		No risk factors reported.		PJP20020497	1						1	Injection site erythema; Injection site swelling; Injection site warmth; Pruritus	FLU3~EVANS VACCINES~E30122FA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233133	02/01/2005					U	08/22/2003	A report was received from a health care professional on 10/10/02, concerning approximately 15 employees, 80 % of who developed injection site reactions after receiving Fluvirin on 10/08/02, approximately. The vaccinees developed erythema ranging from 2 to 6 inches which was hot and swollen at the site of the injection. Vaccinees were administered 0.5ml Fluvirin into the deltoid region of the arm using a tuberculin syringe. It was stated by the reporter that the vaccinees had received a different brand flu vaccine in the past. It was also reported that the reaction had not resolved in all of the vaccinees. There was insufficient information to determine the reporter's causality assessment.									U	10/08/2002	10/08/2002	0		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP20020498	1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233134	02/01/2005					U	08/22/2003	A report was received from a health care professional on 10/11/02, concerning a vaccinee of unknown demography who experienced a medication error after receiving Fluvirin on an unreported date. On an unreported date, a vaccinee was inadvertently administered Fluvirin subcutaneously. No adverse reactions were noted.									U					UNK	UNK	Concomitant Drug Not Reported.		No risk factors reported.		PJP200200499	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233135	02/01/2005		23.0			F	08/22/2003	A report was received from a health professional on 10/11/2002, concerning a 23 year old female vaccinee who experienced an injection site reaction approximately 30 minutes after receiving Fluvirin on 07/10/02. She experienced a red, hot, itchy injection site swelling. There was insufficient information to determine the reporter's causality assessment. 5 other vaccinees vaccinated at the same time with the same batch, had the same reaction. See PJP20020497, PJP200200501, PJP200200502, PJP200200503 and PJP200200504. Update (1) 12/10/02: A report was received from a health care professional, the injection site reaction had resolved at the time of the report.									U	07/10/2002	07/10/2002	0		UNK	UNK	Concomitant Drug Not reported.		No risk factors reported.		PJP200200500	1						1	Injection site erythema; Injection site swelling; Injection site warmth; Pruritus	FLU3~EVANS VACCINES~E30122FA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233136	02/01/2005		38.0			M	08/22/2003	A report was received from a health professional on 10/11/02, concerning a 38 year old male vaccinee who experienced an injection site reaction approximately 30 minutes after receiving Fluvirin on 07/10/02. He experienced a red, hot, itchy injection site swelling. There was insufficient information to determine the reporter's causality assessment. 5 other vaccinees vaccinated at the same time with the same batch, had the same reaction. See PJP200200497, PJP200200500, PJP200200502, PJP200200503, and PJP200200504. Update (1) 12/10/02: A report was received from a health care professional, the injection site reaction had resolved at the time of the report.									U					UNK	UNK	Concomitant Drug Not Reported.		No risk factors reported.		PJP200200501	1						1	Injection site erythema; Injection site swelling; Injection site warmth; Pruritus	FLU3~EVANS VACCINES~E30122FA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233137	02/01/2005		48.0			F	08/22/2003	A report was received from a health professional on 10/11/02, concerning a 48 year old female vaccinee who experienced an injection site reaction approximately 30 minutes after receiving Fluvirin on 07/10/02. The patient experienced a red, hot, itchy injection site swelling. There was insufficient information to determine the reporter's causality. Five other vaccinees vaccinated at the same time with the same batch, had the same reaction. See PJP200200500, PJP20200501, PJP200200497, PJP200200503 and PJP200200504. Update (1) 12/10/2002: A report was received from a health care professional, the injection site reaction had resolved at the time of the report.									U	07/10/2002	07/10/2002	0		UNK	UNK	Concomitant Drug Not Reported.		No risk factors reported.		PJP200200502	1						1	Injection site erythema; Injection site swelling; Injection site warmth; Pruritus	FLU3~EVANS VACCINES~E30122FA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233139	02/01/2005		58.0	58		F	08/22/2003	A report was received from a health professional on 11Oct02, concerning a 58 year old female vaccinee who experienced an injection site reaction approx 30 minutes after receiving Fluvirin on 10Jul02. On 10Jul02, the vaccinee received Fluvirin. Approximately 30 minutes later the vaccinee experienced a red, hot, itchy injection site swelling. There was insufficient information to determine the reporter's causality assessment. 5 other vaccinees vaccinated at the same time with the same batch, had the same reaction. See PJP200200500, PJP200200501, PJP200200502, PJP200200503, and PJP200200497. Update 1 10Dec02, a report was received from a health care professional, the injection site reaction had resolved at the time of the report.									U	07/10/2002	07/10/2002	0		UNK	UNK	NONE		NONE		PJP200200504	1						1	Feeling hot; Injection site erythema; Injection site oedema; Pruritus	FLU3~EVANS VACCINES~E30122FA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233140	02/01/2005		43.0			F	08/22/2003	A report was received from a 43 year old female vaccinee on 04Nov02 who experienced warmth, diarrhea and gas soon after receiving Fluvirin on 31Oct02. On 31Oct02 the vaccinee experienced warmth (temp 99) diarrhea, and gas soon after receiving 0.5ml Fluvirin IM. It was reported that the vaccinee usually develops flu-like symptoms when she gets an annual flu vaccination. The symptoms had not abated at the time of the report.									U	10/31/2002	10/31/2002	0		UNK	UNK	NONE		NONE		PJP200200513	1						1	Diarrhoea; Feeling hot; Flatulence; Similar reaction on previous exposure to drug	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233141	02/01/2005		60.0			M	08/22/2003	A report was received from a health professional on 22Oct02 concerning a 60 year old male vaccinee who experienced fever, chills, and aches after receiving Fluvirin vaccine on 21Oct02. The vaccinee has a thyroid condition and a history of heart and lung complications. On 22Oct02 the vaccinee experienced fever (103 F) chills and muscle aches after receiving Fluvirin 24 hours previously. The vaccinee contacted his physician who instructed the vaccinee to go to the local emergency room for evaluation. At the time of reporting the vaccinee had not recovered. The reporter has assessed the relationship of study medication to the event as possible.									U	10/21/2002	10/22/2002	1		UNK	UNK	NONE		NONE		PJP200200530	1						1	Chills; Myalgia; Pyrexia	FLU3~EVANS VACCINES~~UNK~ID~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233142	02/01/2005					U	08/22/2003	A report was received from a health professional on 11Oct02, concerning 3 vaccinees who were inadvertently admin Fluvirin from a partially frozen vial on an unk date. On an unk date, 3 vaccinees were inadvertently administered Fluvirin from a partially frozen vial: no adverse events were observed. There was insufficient information to determine the reporters causality assessment.									U					UNK	UNK	NONE		NONE		PJP200200536	1						1	Medication error	FLU3~EVANS VACCINES~E32982GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233143	02/01/2005					U	08/22/2003	A report received from a health professional on 22Oct02 concerning 3 vaccinees of unk demography who experienced diarrhea after receiving the Fluvirin vaccine on an unk date. The diarrhea persisted for about 24 hours. The event was reported as resolved. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200200625.									U					UNK	UNK	NONE		NONE		PJP200200537	1						1	Diarrhoea	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233144	02/01/2005		30.0			F	08/22/2003	A report was received from a health professional on 28Oct02, concerning a 30 year old pt who experienced welt formation and redness at injection site after an inadvertent administration of Fluvirin on 22 and 28Oct02. The pt received an initial Fluvirin injection on 22Oct02 IM. On 28Oct02 received the pt inadvertently a second dose of Fluvirin SC in the right forearm. Initially the welt measured approx 16mm in diameter, at the time of reporting the welt was decreased to 4mm in diameter but had not resolved and subsequently experienced redness and formation of a welt at the injection site. The pt was administered a dose of Benadryl as treatment. The reporter has assessed the relationship of study medication to the injection site as probable. (OMIC)									U	10/22/2002	10/28/2002	6		UNK	UNK	NONE		NONE		PJP200200539	1						1	Injection site erythema; Injection site reaction; Medication error; Urticaria	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233145	02/01/2005		37.0			M	08/22/2003	A report was received from a health professional concerning a 37 year old pt, who is a nurse and who experienced an allergic reaction after receiving a Fluvirin vaccine on 16Oct02. The pt has a medical history of latex allergy, no other allergies are known, is not allergic to eggs. On 16Oct02 the pt experienced an allergic reaction after receiving Fluvirin vaccine in the left arm. Within 10 minutes the pt developed general edema, redness from the elbow to shoulder and itching that spread to the torso. The pt was diaphoretic without shortness of breath, RR 20, HR 90, BP 142/68 mmHg. The pt medicated herself with 25mg of diphenhydramine and was seen in the ER, where 60mg of prednisone was administered. The symptoms gradually dissipated that day. The pt had received flu vaccine in previous  years and received about 3 months ago a diphtheria/tetanus vaccination. At the time of reporting the pt had recovered. The reporter has assessed the relationship of study medication to the event as probable. (OMIC)									U	10/16/2002	10/16/2002	0	Blood pressure 16Oct02 142/68mmHg, heart rate 16Oct02 90/min, respiration rate 16Oct02 20/min.	UNK	UNK	NONE		Allergic to latex		PJP200200540	1						1	Hyperhidrosis; Injection site erythema; Injection site oedema; Pruritus	FLU3~EVANS VACCINES~E35792KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233146	02/01/2005		61.0	60		M	08/22/2003	A report was received from a health professional on 25Oct02, concerning seven pt who experienced red, burning, hard nodules at the site of injection, after receiving Fluvirin on 22Oct02. On 22Oct02, seven out of 68 employees who received Fluvirin at a community hospital experienced red, burning, hard nodules at the site of injection within a few hours. The pt's were seen in the ER. The vaccine was administered using a TB syringe with a prefixed needle. It was unk if the pt's recovered. The reporter provided no information on pt specific details. The reporter suspects that these adverse experiences are probably associated with this particular batch of Fluvirin. The following day, additional employees received Fluvirin from a different batch and no adverse experiences were noted. Update 1 20Feb03: A report was received from a health care professional concerning a 60 year old male vaccinee who experienced raised red induration at the injection site 15 minutes after receiving Fluvirin on 20Oct02. The vaccinee was observed in the ER and recovered on 23Oct02. Three other vaccinees had the same reaction to the same batch. See ref: PJP200300088, PJP200300089, PJP200300090.									U	10/20/2002	10/20/2002	0		UNK	UNK	NONE		NONE		PJP200200541	1						1	Injection site erythema; Injection site nodule; Skin burning sensation	FLU3~EVANS VACCINES~E35822KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233147	02/01/2005		48.0	48		F	08/22/2003	A report was received from a healthcare professional on 31Oct02, concerning a 48 year old female vaccinee who experienced back pain, lethargy, loss of appetite, insomnia, feet pain, hand pain and arm pain, approximately 72 hours after receiving Fluvirin on 25Oct02. On 28Oct02, the vaccinee experienced left arm pain (the injection arm) and then right arm pain. The pain continued in her arms and later included the palms of her hands. As a result of the pain, the vaccinee sought medical care at a local ER on 27Oct02 at 11:00PM. The feet, hand and arm pain resolved on an unspecified date. The vaccinee continued to experience back pain, lethargy, loss of appetite and insomnia up to 31Oct02. The vaccinee was scheduled for a follow up visit with her physician on 31Oct02. The reporter has assessed the relationship of the vaccine to the event as possible. Update 1, 22Jan03, A report received from a health care professional indicated that the vaccinee also experienced flu-like muscular aches and chills on 25Oct02, neuritis or nerve pains on 27Oct02, fatigue, muscle weakness, aches and stiffness on 29Oct02 and an upper respiratory infection on approx 09Nov02. The flu-like muscular aches and chills resolved on 26Oct02. The vaccinee was treated with an anti-inflammatory Naprosyn and amoxicillin, salbutamol, loratadine and fluticasone propionate for the respiratory infection. The neuritis or nerve pains, fatigue, muscle weakness, aches and stiffness had not resolved at the time of the report but had much improved. The upper respiratory infection had not resolved at the time of the report. The reporter has assessed the relationship of the vaccine to the flu-like muscle aches and chills, neuritis or nerve pains, fatigue, muscle weakness, aches and stiffness as probable and the upper respiratory infection to be presumed secondary to the compromised immune status of the vaccinee.									U	10/25/2002	10/29/2002	4		UNK	UNK	Atenolol 50mg, Bactrim 21Oct02-26Oct02 1 in 1D, Metro Gel 23Oct02-26Oct02 (2 in 1D)				PJP200200549	1						1	Anorexia; Back pain; Chills; Fatigue; Insomnia; Lethargy; Muscular weakness; Musculoskeletal stiffness; Myalgia; Neuralgia; Neuritis; Pain	FLU3~EVANS VACCINES~E35462HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233148	02/01/2005		72.0			M	08/22/2003	A report was received from a health professional on 17Oct02, concerning a 72 year old male vaccinee who inadvertently received the Fluvirin vaccine on 17Oct02. The vaccinee inadvertently received 0.1ml of Fluvirin ID instead of Tuberculin PPD. The vaccinee has not developed or reported any untoward or adverse reactions. There was insufficient information to determine the reporters causality assessment.									U	10/17/2002				UNK	UNK	NONE		NONE		PJP200200554	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~ID~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233149	02/01/2005		52.0			F	08/22/2003	A report was received from a health professional on 17Oct02, concerning a 52 year old female vaccinee who experienced an injection site reaction, fever and itchiness which started after receiving Fluvirin on 14Oct02. On 14Oct02, the vaccinee received her yearly vaccination. Thirty minutes after the injection, the vaccinee noticed a small welt at the injection site that was itchy and that evening the welt had grown to the size of a baseball and was red, hard, and itchy. She was treated with diphenhydramine hydrochloride cream and capsules with some relief of the itching. She has not yet recovered. The reporter has assessed the relationship of the vaccine to the event as probable.									U	10/14/2002				UNK	UNK	Tiazac, Atenolol, Aspirin, Prilosec		Coronary artery disease, The pt received the Fluvirin vaccine last year and experienced a reaction as well but not as severe. The reaction last year swelled to the size of between a quarter and a silver dollar.		PJP200200555	1						1	Injection site reaction; Pruritus; Pyrexia; Urticaria; Vaccine positive rechallenge	FLU3~EVANS VACCINES~E30412GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233150	02/01/2005		0.51	0	.5	F	08/22/2003	A report was received from a health professional on 18Oct02, concerning a 6 month old female vaccinee who inadvertently received the Fluvirin vaccine on 17Oct02. On 17Oct02 a 6 month old vaccinee received 0.5ml of the Fluvirin vaccine. There was insufficient information to determine the reporters causality assessment.									U	10/17/2002				UNK	UNK	NONE		NONE		PJP200200560	1						1	Medication error	FLU3~EVANS VACCINES~E32852GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233151	02/01/2005		60.0			F	08/22/2003	A report was received from a health professional on 18Oct02, concerning 60 year old female vaccinee who experienced redness and irritation about 3 hours after receiving the Fluvirin vaccine on 10Oct02. On 10Oct02 the vaccinee was administered the Fluvirin vaccine ID. She experienced some redness (about 5cm) and irritation at the injection site about 3 hours after receiving the vaccine. No treatment was given. It was unk if the pt had recovered. The reporter has assessed the relationship of the vaccine to the events as possible.									U	10/10/2002				UNK	UNK	NONE		NONE		PJP200200561	1						1	Injection site erythema; Skin irritation	FLU3~EVANS VACCINES~E32972GA~UNK~ID~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233152	02/01/2005		42.0	42		F	08/22/2003	A report received from a 42 year old female vaccinee who is a health care professional on 15Oct02, who experienced a red swollen hot arm and soreness, minutes after receiving Fluvirin vaccine on 15Oct02. The vaccinee had received the Flu injection for 14 years with no problems. She received 0.5ml to the left arm and within minutes she developed swelling of the entire arm, which also became bright red and hot. Ice packs were applied with no relief. Three hours later the same symptoms and soreness were present. The vaccinee stated that the events were resolving at the time of the report. The reporter has assessed the relationship of the vaccine to the events as probable. Update1 05Dec02: A report was received from a health care professional who was also the vaccinee. The vaccinee also experienced an inability to move her arm on 15Oct02. The vaccinee was given the Fluvirin vaccine at 8:45AM and by 9:00AM the vaccinees arm was red and warm to touch at the injection site. By 9:30AM the vaccinees arm was swollen and the red inflamed area was getting larger and painful. By the end of the day the vaccinee was unable to move her arm without pain radiating from the injection site to the wrist. It interfered with the vaccinees ability to perform her job requirements. The events resolved on an unspecified date. There was insufficient information to determine the reporter's causality assessment.									U	10/15/2002	10/15/2002	0		UNK	UNK	NONE		Hypertension (1981), medically controlled		PJP200200566	1						1	Feeling hot; Hypokinesia; Injection site erythema; Injection site oedema; Injection site pain	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233153	02/01/2005					F	08/22/2003	A report received from a health professional on 15Oct02, concerning a 72 year old female vaccinee who was inadvertently administered partially frozen Fluvirin on 14Oct02. On 14Oct02, the vaccinee was inadvertently administered partially frozen Fluvirin into the left deltoid. The vaccinee has not displayed any signs of symptoms of an adverse reaction. No treatment was administered to the vaccinee. The physician plans to revaccinate the vaccinee in three weeks and will monitor the pt closely for adverse reactions. There is insufficient information to determine the reporters causality assessment.									U	10/14/2002	10/14/2002	0		UNK	UNK	Botox injection Jul2002 ongoing		NONE		PJP200200567	1						1	Medication error	FLU3~EVANS VACCINES~E32982GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233154	02/01/2005		1.11	1	.1	M	08/22/2003	A report was received from a health professional on 16Oct02, concerning 13 month old male vaccinee who was inadvertently administered Fluvirin on 16Oct02. On 16Oct02 a 13 month old male vaccinee was inadvertently administered 0.25ml of Fluvirin vaccine in the right anterior thigh. The vaccinee has not received a previous influenza vaccination. The vaccinee has not exhibited any signs of symptoms of an adverse event and will be closely monitored by the vaccinees mother for adverse reactions. There was insufficient information to determine the reporters causality assessment. Update 1 31Dec02: A report was received from a health care professional which indicated that the vaccinee experienced no adverse event and the physician felt that no treatment was necessary.									U	10/16/2002	10/16/2002	0		UNK	UNK	Fluoride Mar02 0.5mg		Allergic to amoxicillin		PJP200200569	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233155	02/01/2005		0.5			M	08/22/2003	A report was received from a health professional on 16Oct02, concerning a 6 month old male vaccinee who was inadvertently administered the Fluvirin vaccine on 16Oct02. On 16Oct02 the vaccinee was inadvertently administered 0.25ml of the Fluvirin vaccine in the thigh. The vaccinee had not received a previous influenza vaccine. The vaccinee has not exhibited any signs or symptoms of an adverse event. The vaccinee will be closely monitored for adverse reaction. There was insufficient information to determine the reporter's causality assessment.									U	10/16/2002	10/16/2002	0		UNK	UNK	NONE		NONE		PJP200200570	1						1	Medication error	FLU3~EVANS VACCINES~E33702HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233156	02/01/2005					U	08/22/2003	A report was received from a health professional on 17Oct02, concerning a 2 vaccinees of unk demography who experienced shortness of breath after receiving Fluvirin on an unk date. On the unreported date, the vaccinees experienced shortness of breath after receiving Fluvirin. No  other information was available from the reporter. The reporter has assessed the relationship of the vaccine to the event as probable. Ref: PJP200200572, PJP200200573.									U					UNK	UNK	NONE		NONE		PJP200200571	1						1	Dyspnoea	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233157	02/01/2005					U	08/22/2003	A report was received from a health professional on 17Oct02 concerning a vaccinee of unk demography who experienced panic attack, productive cough, and a headache after receiving Fluvirin on an unk date. On an unreported date, the vaccinee experienced a panic attack, headache and a productive cough after receiving Fluvirin. No other information was available from the reporter. The reporter has assessed the relationship of the vaccine to the event as probable. Ref: PJP200200573, PJP200200571.									U					UNK	UNK	NONE		NONE		PJP200200572	1						1	Cough; Headache; Panic reaction	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233158	02/01/2005					U	08/22/2003	A report was received from a health professional on 17Oct02 concerning a group of 10 vaccinees of unk demography who experienced a 4.5 inch wide area of redness at the injection site after receiving Fluvirin on an unk date. On an unreported date, the vaccinees experienced a 4.5 inch wide area of redness around the site of injection.  The reporter has assessed the relationship of the vaccine to the event as probable. The reporter felt that the adverse events were due to a product defect.  Ref: PJP200200572, PJP200200571.									U					UNK	UNK	NONE		NONE		PJP200200573	1						1	Injection site erythema; Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233159	02/01/2005					U	08/22/2003	A report was received from a health  professional on 17Oct02, concerning 8 adult vaccinees who inadvertently received last years Fluvirin vaccine formulation on 16Oct02. Eight vaccinees inadvertently received last years Fluvirin vaccine formulation. The vaccinees have not developed or reported any untoward or adverse reactions. There was insufficient information to determine the reporter's causality assessment.									U	10/16/2002				UNK	UNK	NONE		NONE		PJP200200574	1						1	Medication error	FLU3~EVANS VACCINES~E10801LA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233160	02/01/2005					U	08/22/2003	A report was received from a health care professional on 07Oct02, concerning a number of vaccinees who experienced a medication error after receiving out of date Fluvirin on 07Oct02. On 07Oct02, an unreported number of vaccinees were inadvertently administered last years Fluvirin. No clinical presentation was reported. There was insufficient information to determine the reporter's causality assessment.									U	10/07/2002	10/07/2002	0		UNK	UNK	NONE		NONE		PJP200200578	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233161	02/01/2005		40.0	39		F	08/22/2003	A report was received from a health care professional on 10/18/2002, concerning a 39 year old female vaccinee who experienced pruritus 12 hours after receiving Fluvirin vaccine on 10/15/2002. On 10/15/2002, the patient experienced pruritus on her arm and abdomen. She self-medicated with Benadryl and the pruritus eventually resolved. The reporter has assessed the relationship of the vaccine to the event as probable. Update1. 04/01/2003: A report was received from a health care professional who indicated that the pruritus resolved on 10/16/2002. The vaccinee received the recomendation that she should not receive further vaccinations containing chicken, egg, or thiomersal. The reporter has assessed the relationship of the vaccine to the event as possible.									Y	10/16/2002	10/16/2002	0		UNK	UNK	Tylenol PRN, NSAID's PRN		Childhood allergy to feathers. Previously vaccinated against influenza with no allergic symptoms. Asthma.		PJP200200579	1						1	Hypersensitivity; Pruritus	FLU3~EVANS VACCINES~E34102HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233162	02/01/2005					U	08/22/2003	A report was received from a health care professional on 11/13/2002 concerning a group of approximately 30-40 vaccinees between the ages of 70-80 years who inadvertently received subtherapeutic dose of Fluvirin between 10/20/2002-11/06/2002. Between 10/20/2002-11/06/2002 a group of approximately 30-40 vaccinees inadvertently received a sub-therapeutic dose of Fluvirin when the black line that encircles the syringe was utilized to expel air and prime the needle. There was insufficient information to determine the reporters causality assessment.									U					UNK	UNK					PJP200200580	1						1	Medication error	FLU3~EVANS VACCINES~E31872GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233163	02/01/2005		32.0			M	08/22/2003	A report received from a health care professional on 10/25/2002, concerning a 2 year old vaccinee of unknown sex who inadvertently received 0.25ml  of Fluvirin vaccine on 10/25/2002/. The vaccinee experienced no adverse reaction. There was insufficient information to determine the reporters causality assessment. Update1. 12/10/2002: A report was received from a health care professional which indicated that the vaccinee was a 32 month old male when he received Fluvirin vaccine.									Y	10/25/2002	10/25/2002	0		UNK	UNK					PJP200200581	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~E33922HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233164	02/01/2005					U	08/22/2003	A report was received from a health care professional on 10/25/2002, concerning approximately 100 vaccinees of unknown demography who experienced injection site reaction an unknown time after receiving the Fluviring vaccine during October 2002. During October 2002, the reporter observed anecdotally a higher than ususal incidence of local reactions(warmth and redness) at the injection site. The clinic has administered Fluvirin vaccine to approximately 2000 adult patients since 10/01/2002. The reporter suspected that approximately 100 vaccinees were affected with the adverse event. The events were reported as resolved. The reporter has assessed the relationship of the vaccine to the events as probable.									Y					UNK	UNK					PJP200300584	1						1	Injection site reaction	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233165	02/01/2005					F	08/22/2003	A report was received from a health care professional on 10/23/2002, concerning a female vaccinee of unknown age who inadvertently received frozen Fluvirin vaccine on 10/23/2002. The vaccinee did not experience any adverse event. There was insufficient information to determine the reporters causality assessment. Cross Reference with: PJP200200629, PJP20020774, PJP200200775. Update1. 12/23/2002: A report from a health care professional which indicated that the event was reported to be resolved on an unspecified date.									Y	10/23/2002	10/23/2002	0		UNK	UNK					PJP200200585	1						1	Medication error	FLU3~EVANS VACCINES~E33482HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233166	02/01/2005					U		A report received from a health care professional concerning 70 vaccinees who received Fluvirin on 10/23/2002. On 10/23/2002, 70 vaccinees in a nursing home were administered Fluvirin which was defrosted from frozen. No adverse effects were noted uo to 2 days. The reporter has assessed the relationship of vaccinees to the event unclassifiable.									Y	10/23/2002	10/23/2002	0		UNK	UNK					PJP200200587	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233167	02/01/2005					U		A report received from a health care professional on 10/26/2002, concerning 12 vaccinees of unknown demography who inadvertently received an accidental overdose (1ml) of the Fluvirin vaccine on either 10/25/2002 or 10/26/2002. There were no adverse reactions at the time of the report. There was insufficient information to determine the reporters causality assessment.									Y					UNK	UNK					PJP200200589	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233168	02/01/2005		40.0			F	08/22/2003	A report received from a health care professional on 10/28/2002, concerning a 40 year old female vaccinee who inadvertently received the Fluvirin vaccine subcutaneously on 10/25/2002 and experienced an injection site reaction. On 10/25/2002, the patient complained of warmth, redness and pain at the injection site. On 10/28/2002, the vaccinee stated that the symptoms were relieved, but not completely resolved. The reporter has assessed the relationship of the vaccine to the warmth, redness, and pain as possible, and the inadvertent subcutaneous administration as unclassigied.									U	10/25/2002	10/25/2002	0		UNK	UNK					PJP200200592	1						1	Injection site erythema; Injection site pain; Injection site warmth; Medication error	FLU3~EVANS VACCINES~~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233169	02/01/2005		41.0	40		F	08/22/2003	A report was received from a health care professional on 10/28/2002, concerning a 40 year old female vaccinee who experienced an injection site reaction, and swelling of the clavicular and axillary lymph nodes after receiving the 0.1ml  of Fluvirin vaccine subcutaneously on 10/24/2002. On 10/25/2002, the vaccinee noticed a swelling at the site of administration as well as swelling of her axillary and clavicular lymph The local swelling resolved on 10/26/2002 and the swelling of the axillary lymph nodes resolved on 10/27/2002. The clavicular lymph node swelling has improved greatly but has not completely resolved. The reporter has assessed the relationship of the vaccine to the events as possible. Update1./ 01/02/2003: A report was received from a health care professional which indicated that the vaccinee experienced supraclavicular lymph node swelling on 10/26/2002. No action was taken for the swelling which resolved. The vaccinee recovered on 11/02/2002. The reporter has assessed the relationship of the vaccine to the supraclavicular lymph node swelling as probable.									Y	10/24/2002	10/24/2002	0		UNK	UNK	Zyrtec-10mg daily, Oral Contraceptive- daily, NeoSynephrine- PRN, Flonase- PRN, Astelin-PRN,		Receiving immunotherapy for dust mites, cat, dog, and molds.		PJP200200595	1						1	Injection site reaction; Injection site swelling; Lymphoedema	FLU3~EVANS VACCINES~E33162GA~UNK~ID~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233170	02/01/2005		47.0	46		F	08/22/2003	A report was received from a health care professional on 10/21/2002, concerning a 46 year old female vaccinee who experienced a large welt over the deltoid region of her arm which was described as red, hot and swollen after receiving 0.5ml Fluvirin on 10/15/2002. On 10/15/2002, the vaccinee received 0.5ml Fluvirin intramuscularly. On 10/16/2002 she had developed a large welt described as the size of the vaccinees bicep, which was red, swollen and hot. The vaccinee recovered on 10/18/2002 There was insufficient information to determine the reporters causality assessment. Reference: PJP200200602, PJP200200601, PJP200300598, PJP200200597.									Y	10/15/2002	10/15/2002	0		UNK	UNK					PJP200200596	1						1	Injection site erythema; Injection site mass; Injection site oedema; Injection site warmth	FLU3~EVANS VACCINES~E3392HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233171	02/01/2005		39.0	38		F	08/22/2003	A report was received from a health care professional on 10/21/02 concerning a 38 year old female vaccinee who developed a welt over the deltoid region of her arm which was described as red, swollen, hot and painful after receiving 0.5 ml Fluvirin on 10/15/02. On 10/15/2002 the vaccinee received 0.5 ml Fluvirin intramuscularly. On 10/16/02 she had developed a welt over the deltoid region of her arm, which was also described as red, swollen, hand and painful. The vaccinee was reported as recovered since 10/18/02. There was insufficient information to determine the reporter's causality assessment. Ref: PJP200200596, PJP200200601, PJP200200602 and PJP200200598.									Y	10/15/2002	10/16/2002	1		UNK	UNK	Concomitant Drug Not Used		No risk factors reported		PJP200200597	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Urticaria	FLU3~EVANS VACCINES~E33922HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233172	02/01/2005		46.0	46		F	08/22/2003	A report was received from a health care professional on 10/21/02 concerning a 46 year old female vaccinee who developed a welt over the deltoid region of her arm on 10/16/02,  which was described as red, swollen, painful and warm after receiving 0.5 ml Fluvirin on 10/15/02. The vaccinee was reported as recovered since 10/18/2002. There was insufficient information to determine the reporter's causality assessment. Ref: PJP200200596, PJP200200601, PJP200200602 and PJP200200597.									Y	10/15/2002	10/16/2002	1		UNK	UNK	Concomitant Drug Not Used.		No risk factors reported.		PJP200200598	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Urticaria	FLU3~EVANS VACCINES~E33922HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233173	02/01/2005					M	08/22/2003	A report was received from a health professional on 10/23/02, concerning a male vaccinee of unknown age who was inadvertently administered the Fluvirin vaccine subcutaneously on 10/23/02. The vaccinee did not experienced any adverse event. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200200611.									U	10/23/2002				UNK	UNK	Concomitant Drug Not reported		No risk factors reported.		PJP200200599	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233174	02/01/2005		2.0	2	.1	M	08/22/2003	A report was received from a health professional on 10/23/02, concerning a 2 year old male vaccine who was inadvertently administered Fluvirin vaccine on 10/23/02. The vaccinee experienced no adverse reaction. There was insufficient information to determine the reporter's causality assessment.									U	10/23/2002				UNK	UNK	Concomitant Drugs Not Used.		No risk factors reported.		PJP200200600	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233175	02/01/2005		50.0	50		F	08/22/2003	A report was received from a health care professional on 10/21/2002 concerning a 50 year old female vaccinee who developed diarrhea and experienced a large welt over the deltoid region of her arm which was described as red, swollen, painful, warm and itching on 10/16/02,  after receiving 0.5 ml of Fluvirin on 10/15/02. The vaccine was administered intramuscularly. The welt was treated with ice and paracetamol. The vaccinee was reported as recovered since 10/18/02. There was insufficient information to determine the reporter's causality assessment. Ref: PJP200200602, PJP200200598, PJP200200597 and PJP200200596.									Y	10/15/2002	10/16/2002	1		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200200601	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pruritus; Urticaria	FLU3~EVANS VACCINES~E33922HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233176	02/01/2005		38.0	38		F	08/22/2003	A report was received from a health care professional on 10/21/2002, concerning a 38 year old female vaccinee who experienced a large welt over the deltoid region of her arm which was described as red and swollen, and the armpit gland was reported as sore on 10/16/02, after receiving 0.5 ml Fluvirin on 10/15/02. The vaccinee was reported as recovered since 10/18/02. There was insufficient information to determine the reporter's causality assessment. Ref: PJP200200601, PJP200200598, PJP200200597, PJP200200596.									Y	10/15/2002	10/16/2002	1		UNK	UNK	Concomitant Drug Not Reported.		No risk factors reported		PJP200200602	1						1	Injection site erythema; Injection site swelling; Lymph node pain; Urticaria	FLU3~EVANS VACCINES~E33922HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233177	02/01/2005		52.0			F	08/22/2003	A report received from a health professional on 10/28/2002, concerning a 52 year old female vaccinee who received 2 doses of the influenza vaccine (one Fluvirin, one Brand unknown) on 10/26/02. On 10/26/2002, the vaccinee went to 2 separate clinics and received 2 separate doses of the Fluvirin vaccination with the intent of receiving greater immunogenic protection from the vaccine. No adverse reaction was reported. There was insufficient information to determine the reporter's causality assessment.									U	10/26/2002				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200200603	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0233178	02/01/2005					U	08/22/2003	A report was received from a health professional on 10/25/02, concerning as unknown number of vaccinees of unknown demography who experienced injection site reactions after receiving the Fluvirin vaccine on 10/11/02. On 10/11/02, an unspecified number of vaccines experienced redness, swelling and soreness at the injection site. There was insufficient information to determine the reporter's causality assessment.									U	10/11/2002	10/11/2002	0		UNK	UNK	Concomitant Drug Not Reported	No risk factors reported			PJP200200604	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~EVANS VACCINES~E34102HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233179	02/01/2005		69.0	68		F	08/22/2003	A report was received from a health professional on 10/21/02, concerning a 69 year old female vaccinee who was administered expired Fluvirin vaccine on 10/21/02. The vaccinee did not experienced any adverse effects. The reporter has assessed the relationship of the vaccine to the event as unclassifiable. Update (1) 12/12/02: A follow up report was received from a health care professional. The vaccinee received Fluvirin subcutaneously on 10/21/02. The vaccinee received the 2002-2003 formulation of influenza vaccine (brand unspecified) on 11/15/02.									U	10/21/2002				UNK	UNK	Glucotrol XL and Glucophage		No risk factors reported.		PJP200200605	1						1	Medication error	FLU3~EVANS VACCINES~E02121HA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233180	02/01/2005		46.0			M	08/22/2003	A report was received from a health professional on 10/21/02, concerning a 46 year old male vaccinee who experienced worsening hearing loss right after receiving the flu vaccine (brand unspecified) in September 2002. The patient was diagnosed with mild to moderate hearing loss in his right ear and moderate to severe hearing loss in his left ear in June 2002. On 10/16/02, the vaccinee was evaluated at an audiology clinic different from the one he was evaluated at in June 2002. It was noted that he had worsening hearing loss in his right ear. The vaccinee had received previous influenza vaccines in the past 4-5 years, without a similar adverse reaction. The reporter has assessed the relationship of the vaccine to the event as unrelated.									U					UNK	UNK	Chinese Herbs and Ambien		No risk factors reported. Hearing loss, Insomnia and Labile Hypertension.		PJP200200606	1						1	Hypoacusis	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233181	02/01/2005		70.0			M	08/22/2003	A report was received from a healthcare professional on 10/29/2002, concerning a 70 year old male vaccinee who received last years batch of Fluvirin intramuscularly on 10/23/2002. ON 10/23/2002, the vaccinee was inadvertently administered last years batch of Fluvirin (dated 30 June 2002) intramuscularly.  It was reported that the vaccinee did not experience any adverse event in relation to the incident. The reporter has assessed the relationship of the vaccine to the event as related.									U	10/23/2002	10/23/2002	0		UNK	UNK	Concomitant drug not used.		No risk factors reported.		PJP200200607	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233182	02/01/2005		1.19	1	.2	F	08/22/2003	A report was received from a healthcare professional on 10/16/2002, concerning a 14 month old female vaccine who was inadvertently administered 0.25ml intramuscularly in the vastus lateralis on the 15 October 2002. On 10/15/2002, the vaccinee suffered a medication error by receiving 0.25ml Fluvirin into the vastus lateralis.  The vaccinee had not experienced any adverse events at the time of the report but was being closely monitored. There was insufficient information to determine the reporter's causality assessment.									U	10/15/2002	10/15/2002	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200200609	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233183	02/01/2005		2.0	2	.1	F	08/22/2003	A report was received from a health professional on 10/21/2002, concerning a 24 month old female vaccinee who inadvertently received the Fluvirin vaccine on 10/21/2002. On 10/21/2002, a 24 month old female vaccinee was inadvertently administered the Fluvirin vaccine.  The vaccinee had not received a previous influenza vaccination.  The vaccinee had not showed any signs or symptoms of an adverse event at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1 01/06/2003 The reporter stated that the vaccinee was given the incorrect dose, the vaccinee was less than 8 years old and was given the dose for vaccinees greater than 8 years old.  The parent was notified, but the vaccinee had experienced no adverse reaction 72 hours after the vaccination.									U	10/21/2002	10/21/2002	0		UNK	UNK	Concomitant drug not used.		No risk factors reported. No known drug allergies.		PJP200200610	1						1	Medication error	FLU3~EVANS VACCINES~E33702HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233184	02/01/2005		30.0	30		F	08/22/2003	A report was received from a health professional on 10/23/2002, concerning a 30 year old female vaccinee who was inadvertently administered the Fluvirin vaccine subcutaneously on 10/23/2002.  The vaccinee did not experience any adverse event. There was insufficient information to determine the reporters causality assessment.									U	10/23/2002	10/23/2002	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200200611	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233185	02/01/2005					F	08/22/2003	A report received from a health professional on 10/29/2002, concerning a female vaccinee who received Fluvirin on 10/29/2002. On 10/29/2002, the vaccinee was inadvertently administered 2001-2002 Fluvirin.  The vaccinee did not experience any adverse event. There was insufficient information to determine the reporter's causality assessment.									U	10/29/2002	10/29/2002	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200200612	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233186	02/01/2005		22.0	22		F	08/22/2003	A report was received from a health professional on 10/21/02, concerning a female vaccinee in her early 30's who experienced finger tingling after receiving Fluvirin vaccine on approximately 10/15/02. On approximately 10/15/02, on the evening of the same day that she received her Fluvirin vaccination the vaccinee experienced finger tingling in her ring and little fingers. The finger tingling had not resolved at the time of this report. The reporter has assess the relationship of the vaccine to the event as unclassifiable. Update (1) 01/02/03: The 22 year old vaccinee experienced Raynaud's disease a few hours after receiving the Fluvirin vaccine in the left deltoid muscle. The vaccinee experienced tingling in the left ring and pinky finger on 10/15/02, which lasted for several days. The attending nurse recommended ibuprofen. The vaccinee has recovered.									Y	10/15/2002	10/15/2002	0		UNK	UNK	Concomitant Drug Not Reported.		No risk factors reported. Allergy to sulpha drugs.		PJP200200613	1						1	Paraesthesia; Raynaud's phenomenon	FLU3~EVANS VACCINES~E32852GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233187	02/01/2005		38.0			M	08/22/2003	A report was received from a health care professional on 10/29/02, concerning a 38 year old male vaccinee who experienced an injection site reaction after receiving Fluvirin on 10/23/02. On 10/24/02, the vaccinee developed a 8x' area of redness, swelling, tenderness and itching near the injection site. The vaccinee has not yet recovered. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/13/02:A follow up report received from a health care professional indicated that the vaccinee received Fluvirin via subcutaneous injection inferior to the deltoid muscle. Symptoms of the adverse event also included redness, induration and itching around the injection site. The vaccinee recovered after 8 days.									Y	10/23/2002	10/24/2002	1		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200200614	1						1	Injection site erythema; Injection site pain; Injection site swelling; Medication error; Pruritus	FLU3~EVANS VACCINES~E31212GA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233188	02/01/2005					U	08/22/2003	A report was received from a health professional on 10/21/02, concerning 12 adult vaccinee's who were inadvertently administered frozen Fluvirin vaccine on 10/18/02. They will be re-vaccinated in approximately 4 weeks. The vaccinee's have not experienced any adverse effects. The reporter has assessed the relationship of the vaccine to the event as unclassifiable.									U	10/18/2002				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200200615	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233189	02/01/2005					U	08/22/2003	A report was received from a health care professional on 11/13/02, concerning a group of 46 vaccinees of unknown demography who experienced sore arms and developed the flu 2-3 weeks after administration of Fluvirin on an unreported date. There was insufficent information to determine the reporter's causality assessment.									U					UNK	UNK	Concomitant Drug Not Used.		No risk factors reported.		PJP200200616	1						1	Drug ineffective; Infection; Pain	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233190	02/01/2005		40.0			F	08/22/2003	A report was received from a health care professional on 10/29/02, concerning a 40 year old female vaccinee who experienced an injection site reaction 1 day after receiving fluvirin vaccine on 10/23/2002. On 10/24/02, the vaccinee developed a 8x 6 area of redness, swelling, tenderness and itching near the injection site. The vaccinee has not yet recovered. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/13/02: A follow up report received from a health care professional indicated that the vaccinee received Fluvirin via subcutaneous injection inferior to the deltoid muscle. Symptoms of the event included induration around the injection site. The vaccinee recovered after 7 days. Ref: PJP200200614 and PJP200200619.									Y	10/23/2002	10/24/2002	1		UNK	UNK	Concomitant Drug Not Reported.		No risk factors reported.		PJP200200617	1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling; Medication error; Pruritus	FLU3~EVANS VACCINES~E31212GA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233191	02/01/2005		60.0			F	08/22/2003	A report was received from a customer on 10/24/2002, concerning a 60 year old female vaccinee who experienced injection site redness, swelling and hardness 1 day after, and flu-like symptoms 2 days after receiving the Fluvirin vaccine on 10/21/2002. On 10/21/2002, the patient received her flu vaccination in the left arm. One day later, the arm became red, swollen and was very hard at the injection site. On 10/23/2002, the vaccinee experienced flu-like symptoms including chills and coldness. The vaccinee last received flu vaccination several years ago with no allergic reactions.									U	10/21/2002	10/22/2002	1		UNK	UNK					PJP200200618	1						1	Chills; Feeling cold; Influenza like illness; Injection site erythema; Injection site induration; Injection site swelling	FLU3~EVANS VACCINES~~2~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233192	02/01/2005		25.0			F	08/22/2003	A report received from a health care professional on 10/29/2002, concerning a 25 year old female vaccinee who experienced an injection site reaction after receiving Fluvirin on 10/23/2002. On 10/24/2002, the vaccinee developed a 3 X 3 area of redness, swelling, tenderness and itching near the injection site. The vaccinee has not yet recovered. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/11/2002,  A follow-up report received from a health care professional indicated that other symptoms of the event included swelling and ecchymosis superior to the injection site. The vaccinee recovered after 3 days.									Y	10/23/2002	10/24/2002	1		UNK	UNK					PJP200200619	1						1	Ecchymosis; Injection site erythema; Injection site swelling; Swelling; Tenderness	FLU3~EVANS VACCINES~E31212GA~2~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233193	02/01/2005		1.05	1	.1	M	08/22/2003	A report was received from a health care professional on 10/24/2002, concerning a 12 month old male vaccinee who inadvertently received 0.25 ml Fluvirin intramuscularly on 10/23/2002. On 10/23/2002, the vaccinee experienced a medication error following inadvertent administration of 0.25 ml Fluvirin intramuscularly. No adverse event was reported. There was insufficient information to determine the reporter's causality assessment. Update 1 12/09/2002: A follow up report was received from a health care professional on 12/09/2002. It was reported that the vaccinee received 0.5 ml Fluvirin subcutaneously on 10/23/2002. No adverse reaction was reported.									Y	10/23/2002	10/23/2002	0		UNK	UNK	Pediasure		failure to thrive		PJP200200620	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~E30442GA~2~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233194	02/01/2005		0.45	0	.4	M	08/22/2003	A report received from a health professional on 10/22/2002, concerning a 5 month old male vaccinee who inadvertently received the Fluvirin vaccine on 10/18/2001. The vaccinee experienced no adverse event. There was insufficient information to determine the reporter's causality assessment.									U	10/18/2001	10/18/2001	0		UNK	UNK					PJP200200621	1						1	Medication error	FLU3~EVANS VACCINES~E34582HA~2~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233195	02/01/2005		0.98	0	1	F	08/23/2003	A report received from a health professional on 10/22/2002, concerning an 11 month old female vaccinee who inadvertently received the Fluvirin vaccine on 10/11/2002. The vaccinee experienced no adverse event. There was insufficient information to determine the reporter's causality assessment.									Y	10/11/2002	10/11/2002	0		UNK	UNK					PJP200200622	1						1	Medication error	FLU3~EVANS VACCINES~E34682HA~2~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233196	02/01/2005		42.0			F	08/22/2003	A report was received from a health care professional on 10/15/02, concerning a vaccinee who experienced a red, hot swollen arm after receiving Fluvirin on 10/5/02. On 10/15/02, the vaccine received 0.5ml Fluvirin to the left arm and within minutes developed swelling of the entire arm which was also red and hot. Ice packs were applied with no relief. The vaccinee had not recovered at the time of the report. The reporter has assessed the relationship of the vaccine to the event as probable.									N	10/15/2002	10/15/2002	0		UNK	UNK	Concomitant Drug Not Reported.		No risk factors reported.		PJP200200623	1						1	Erythema; Feeling hot; Oedema peripheral	FLU3~EVANS VACCINES~E35732HA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233197	02/01/2005		0.57	0	.6	M	08/22/2003	A report was received from a health professional on 0/22/02, concerning a 6 month old male vaccinee who inadvertently received the Fluvirin vaccine on 10/11/02. The vaccinee experienced no adverse event. There was insufficient information to determine the reporter's causality assessment. Cross referenced with PJP200200621 and PJP200200622.									U	10/11/2002				UNK	UNK	Concomitant Drug Not Reported.		No risk factors reported.		PJP200200624	1						1	Medication error	FLU3~EVANS VACCINES~E34682HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233198	02/01/2005					M	08/22/2003	A report received from a health professional on 10/22/02, concerning a male vaccinee in his 70's who experienced diarrhea on 10/18/02, after receiving the Fluvirin vaccine on 10/18/02. That evening he developed watery stools every 2 hours which was persisting at the time of the report. The vaccinee has not recovered. The reporter has assessed the relationship of the medication to the event as unknown. Cross reference with PJP20020537.									N	10/18/2002	10/18/2002	0		UNK	UNK	Concomitant Drug Not Reported.		No risk factors reported.		PJP20200625	1						1	Diarrhoea	FLU3~EVANS VACCINES~E34672HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233199	02/01/2005		53.0			M	08/22/2003	A report was received from a consumer concerning a 53 year old male vaccine who inadvertently received 1ml Fluvirin on 10/30/02. The vaccinee experienced no adverse reaction.									U	10/30/2002				UNK	UNK	Concomitant Drug Not Used.		No risk factors reported.		PJP200200626	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233200	02/01/2005		37.0			F	08/22/2003	A report was received from a health care professional on 10/24/2002, concerning a 37 year old female vaccinee and approximately 10 other staff who inadvertently received Fluvirin subcutaneously in 10/2002. In October 2002, the vaccinee and approximately 10 others experienced inadvertent administration of Fluvirin receiving 0.5ml of Fluvirin Subcutaneously with 5/16 inch needles. No adverse event was reported in relation to the incident. There was insufficient information to determine the reporter's causality assessment.									U					UNK	UNK	Concomitant Drug Not Used.		No risk factors reported.		PJP200200627	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233201	02/01/2005		27.0	26		F	08/22/2003	A report was received from a healthcare professional on 10/24/2002, concerning a 26 year old female vaccinee who experienced warmth, tingling, redness and soreness and developed a softball-sized lump at the injection site after receiving Fluvirin intramuscularly on 10/23/2002. On 10/23/2002, the vaccinee experienced warmth, tingling, redness, soreness and a lump at the injection site after receiving 0.5ml Fluvirin intramuscularly on 10/23/2002.  It was reported that the attending physician suspected that the vaccinee may be allergic to the drug.  The vaccinee has received an influenza vaccine for the past 6 years without any problems.  Symptoms had not resolved at the time of the reporting. There was insufficient information to determine the reporter's causality assessment.									U	10/23/2002	10/23/2002	0		UNK	UNK	Birth control Pills		No risk factors reported.		PJP200200628	1						1	Erythema; Feeling hot; Injection site mass; Pain; Paraesthesia	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233202	02/01/2005					F	08/22/2003	A report was received from a health professional on 10/23/2002, concerning a female vaccinee of unknown age who inadvertently received frozen Fluvirin vaccine on 10/23/2002.  The vaccinee did not experience any adverse event. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP-2002-00585, PJP-2002-00775. Update 1 12/23/2002 A report was received from a healthcare professional which indicated that the event resolved on an unspecified date.									U	10/23/2002				UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200200629	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233203	02/01/2005		74.0			F	08/22/2003	A report was received from a health professional on 10/30/2002, concerning a vaccinee of unknown demography, who was inadvertently administered expired Fluvirin on an unknown date in September 2002. On an unknown date in September 2002, the vaccinee was administered with 2001-2002 Fluvirin formulation. There was insufficient information to determine the reporter's causality assessment. Update 1, January 9, 2003: A follow up report was received from a healthcare professional indicating that a 74 year old female vaccinee did not experience an adverse event after inadvertent administration of expired Fluvirin on an unreported date in September 2002.									U					UNK	UNK	Insulin Prilosec Fosamax Allegra Prempro Aspirin Calcium		No risk factors reported.  No known drug allergies.  Diabetic, Osteoporosis, Hypercholesterolemia.		PJP200200630	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233204	02/01/2005					U	08/22/2003	A report was received from a health professional on 10/23/2002, concerning 70 children under 4 years of age who were inadvertently administered Fluvirin vaccine between approximately 10/01/2002 and 10/23/2002. Between approximately 10/01/2002 and 10/23/2002, 70 children under 4 years of age were inadvertently administered Fluvirin 0.25ml intramuscularly.  None of the vaccinees have exhibited any signs or symptoms of an adverse event but will be closely monitored. There was insufficient information to determine the reporters causality assessment.									U					UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200200631	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233205	02/01/2005					U	08/22/2003	A report received from a health professional on 10/29/2002, concerning approximately 25 vaccinees of unknown demography who experienced swelling, redness and soreness at the injection site an unknown time after receiving the Fluvirin vaccine between 10/14/2002 and 10/29/2002. Between 10/14/2002 and 10/29/2002, approximately 25 patients reported having swelling, redness and soreness at the injection site after receiving the Fluvirin vaccine.  The reporter stated that she has been administering the influenza vaccine for many years and that she has seen now an exceptionally high incidence of local reactions in her vaccinees.  Her estimation was that approximately 50% of the vaccinees experienced local reactions.  The reporter has assessed the relationship of the vaccine to the events as probable.									U					UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200200632	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~EVANS VACCINES~E30442GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233206	02/01/2005		25.0			M	08/22/2003	A report was received from a pharmacy student on 10/24/2002, concerning a 25 year old male vaccinee who received 0.5ml Fluvirin intramuscularly.  However half the dose spilled while being administered. On 10/24/2002, the vaccinee experienced a medication error when half of the Fluvirin vaccine he was receiving spilled onto his arm.  It was reported that the vaccinee did not experience any adverse effects. The reporter has assess the relationship of the event to the medication as unclassifiable.									U					UNK	UNK	Concomitant drug not used.		No risk factors reported.		PJP200200633	1						1	Medication error	FLU3~EVANS VACCINES~E30432GA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233207	02/01/2005		1.0			F	08/22/2003	A report received from a health professional on 10/10/2002, concerning an 18 month old female vaccinee who inadvertently received Fluvirin on 10/30/2002. On 10/30/2002, the vaccinee was inadvertently administered Fluvirin.  The vaccinee was less than 4 years old.  The vaccinee did not experience any adverse event. There was insufficient information to determine the reporter's causality assessment. Update 1, 01/03/2002. A report was received from a healthcare professional which confirmed that the vaccinee had still not experience any adverse effects at the time of the report.									U					UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200200634	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233208	02/01/2005		50.0	50		F	08/22/2003	A report was received from a health professional on 10/30/2002, concerning approximately 10 vaccinees who inadvertently received last year's Fluvirin.  From 10/28/2002 to 10/30/2002, approximately 10 vaccinees were inadvertently vaccinated with expired Fluvirin. There was insufficient information to determine the reporter's causality assessment. Update 1, 01/27/2003. A report was received from a healthcare professional concerning a 50 year old female vaccinee who received expired influenza vaccine (brand unspecified) on an unspecified date.  The vaccinee was subsequently re-vaccinated with this years influenza vaccination and experienced no adverse reaction.									U	10/28/2002				UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200200635	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233209	02/01/2005		2.0	2	.2	M	08/22/2003	A report received from a health professional on 10/24/2002, concerning a 2 year old male vaccinee who inadvertently received Fluvirin vaccine on 10/17/2002.  The vaccinee experienced no adverse reaction. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/11/2002. One dose of Fluvirin was administered a second dose due one month later was withheld.									U	10/17/2002				UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200200636	1						1	Medication error	FLU3~EVANS VACCINES~E32972GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233210	02/01/2005					U	08/22/2003	A report was received from a healthcare professional on 10/31/2002, concerning a group of vaccinees less than 4 years old who had been vaccinated with Fluvirin from 10/21/2002 to 10/31/2002. Between 10/21/2002 and 10/31/2002, an unreported number of vaccinees less than 4 years old inadvertently received 0.25ml Fluvirin intramuscularly.  No adverse events were reported. There was insufficient information to determine the reporter's causality assessment.									U		10/21/2002			UNK	UNK	Concomitant drug not used.		No risk factors reported.		PJP200200637	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233211	02/01/2005		40.0			F	08/22/2003	A report was received from a health professional on 23Oct02, concerning a 39 year old female health professional who was inadvertently administered Fluvirin vaccine in Oct 2002. The vaccinee did not experience any adverse event. The event resolved. There was insufficient information to determine the reporters causality assessment. Cross-reference with PJP 2002 00640. Update 1 09Dec02: A report was received from a health care professional which indicated that the 40 year old vaccinee received the Fluvirin vaccine on 23Oct02.									U	10/23/2002				UNK	UNK	Diabetic Medications		Diabetes		PJP200200638	1						1	Medication error	FLU3~EVANS VACCINES~E05231KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233212	02/01/2005		39.0			F	08/22/2003	A report was received from a health professional on 23Oct02, concerning a 39 year old female health professional who was inadvertently administered Fluvirin vaccine in Oct 2002. The health professional did not experience any adverse event. The event resolved. There was insufficient information to determine the reporters causality assessment. Cross-reference with PJP 2002 00638. Update 1 09Dec02: The vaccinee received the Fluvirin vaccine on 23Oct02.									U	10/23/2002				UNK	UNK	NONE		NONE		PJP200200640	1						1	Medication error	FLU3~EVANS VACCINES~E05231KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233213	02/01/2005		52.0			M	08/22/2003	A report was received from a health professional on 23Oct02, concerning a 52 year old male vaccinee who experienced large (about the size of an apple), red, hot patches at and around the site of injection and pain under the arm after receiving the Fluvirin vaccine on 21Oct02. On 21Oct02, the vaccinee developed large (about the size of an apple), red, hot patches at and around the site of injection and pain under the arm. There were no signs of fever or illness. The reporter has assessed the relationship of the vaccine to the event as probably related particularly due to the needle length.									U	10/21/2002	10/21/2002	0		UNK	UNK	NONE		NONE		PJP200200642	1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~EVANS VACCINES~E33092HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233214	02/01/2005					U	08/22/2003	A report was received from a health professional on 22Oct02, concerning a female vaccinee who developed upper respiratory symptoms after receiving Fluvirin on an unk date.  On an unk date, the vaccinee received an unknown dose of Fluvirin through a route unk. She developed upper respiratory symptoms and the outcome was reported as unk. The vaccinee has received annual flu vaccinations for 10 years without any adverse reaction.  There was insufficient information to determine the reporters causality assessment. Cross-reference with PJP 2002 00638. Update 1 09Dec02: The vaccinee received the Fluvirin vaccine on 23Oct02. Ref: PJP200200647; PJP200200649.									U					UNK	UNK	NONE		NONE		PJP200200645	1						1	Upper respiratory tract infection	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233215	02/01/2005					M	08/22/2003	A report was received from a health professional on 22Oct02, concerning a vaccinee of unk demography who experienced nausea after receiving Fluvirin on an unk date. The vaccinee developed  nausea on an unk date. The vaccinee received a previous Flu vaccine with no adverse effects.  It was unk if the vaccinee had recovered.  There was insufficient information to determine the reporters causality assessment. Ref: PJP200200645; PJP200200649.									U					UNK	UNK	NONE		NONE		PJP200200647	1						1	Nausea	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233216	02/01/2005					U	08/22/2003	A report was received from a health professional on 22Oct02, concerning a vaccinee of unk demography who developed an asthmatic reaction after receiving Fluvirin on an unk date. On an unk date, the vaccinee received an unknown dose of Fluvirin via an unk route. She developed an asthmatic reaction. The vaccinee had received annual flu vaccination for 10 years without any adverse reaction. There was insufficient information to determine the reporters causality assessment.  Ref: PJP200200647; PJP200200645.									U					UNK	UNK	NONE		NONE		PJP200200649	1						1	Asthma	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233217	02/01/2005					F	08/22/2003	A report was received from a health care professional concerning a 22 year old female vaccinee who inadvertently administered last years Fluvirin formulation on 24Oct02. On 24Oct02, the vaccinee inadvertently administered last year's Fluvirin vaccine. No adverse event was reported to be associated with the incident. There was insufficient information to determine the reporters causality assessment. Ref: PJP200200654; PJP200200652;PJP200200651; PJP200200653.									U	10/24/2002	10/24/2002	0		UNK	UNK	NONE		NONE		PJP200200650	1						1	Medication error	FLU3~EVANS VACCINES~E04821KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233218	02/01/2005					F	08/22/2003	A report was received from a health care professional concerning a 22 year old female vaccinee who inadvertently administered last years Fluvirin formulation on 24Oct02. On 24Oct02, the vaccinee inadvertently administered last year's Fluvirin vaccine. No adverse event was reported to be associated with the incident. There was insufficient information to determine the reporters causality assessment. Ref: PJP200200654; PJP200200652;PJP200200650; PJP200200653.									U	10/24/2002	10/24/2002	0		UNK	UNK	NONE		NONE		PJP200200651	1						1	Medication error	FLU3~EVANS VACCINES~E04821KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233219	02/01/2005					U	08/22/2003	A report was received from a health care professional concerning a female vaccinee who inadvertently administered last years Fluvirin vaccine on 24Oct02. On 24Oct02, the vaccinee inadvertently administered last year's Fluvirin formulation. No adverse event was reported to be associated with the incident. There was insufficient information to determine the reporters causality assessment. Ref: PJP200200654; PJP200200651;PJP200200650; PJP200200653.									U	10/24/2002	10/24/2002	0		UNK	UNK	NONE		NONE		PJP200200652	1						1	Medication error	FLU3~EVANS VACCINES~E04821KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233220	02/01/2005					F	08/22/2003	A report was received from a health care professional concerning a female vaccinee who inadvertently administered out of date Fluvirin formulation on 24Oct02. On 24Oct02, the vaccinee was inadvertently administered last year's Fluvirin formulation. No adverse event was reported as a result of the incident. There was insufficient information to determine the reporters causality assessment. Ref: PJP200200654; PJP200200652;PJP200200651; PJP200200650.									U	10/24/2002	10/24/2002	0		UNK	UNK	NONE		NONE		PJP200200653	1						1	Medication error	FLU3~EVANS VACCINES~E04821KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233221	02/01/2005	MD	16.0	15		M	08/22/2003	A report was received from a health care professional, concerning a 15 year old male vaccinee who was inadvertently administered last years Fluvirin formulation on 10/24/02. No adverse effect was reported. There was insufficient information to determine the reporter's causality assessment. Ref: PJP2002-00652, PJP200200651 and PJP200200650.									U	10/24/2002				UNK	UNK	Concomitant Drug Not Used.		No risk factors reported.		PJP200200654	1						1	Medication error	FLU3~EVANS VACCINES~E04821KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233222	02/01/2005		33.0	33		F	08/22/2003	A report received on 10/25/02, concerning a 33 year old female vaccinee and approximately 15 clinic staff members who were inadvertently administered Fluvirin in error in 10/2002. The reporter suspected that the staff members may have received the vaccine subcutaneously and not intramuscularly. No adverse effects were reported. The reporter has assessed the relationship of the vaccines to the event as unclassifiable. A report received from a health professional on 10/13/2002, indicated that 7 vaccinees were administered Fluvirin subcutaneously on 10/08/02. The outcome of the event was reported as unknown. Ref: PJP200200890, PJP200200882, PJP200200883, PJP200200885 and PJP200200889.									U	10/08/2002				UNK	UNK	Concomitant Drug Not Used.		No risk factors reported. NONE		PJP200200657	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233223	02/01/2005					U	08/22/2003	A report was received from a health professional on 10/23/02, concerning 40 vaccinees of unknown demography who experienced injection site reactions fro an unspecified length of time after receiving Fluvirin vaccine in September 2002. On various dates the physician received various anecdotal reports from up to 40 vaccinees of localized muscular reactions such as soreness, inflammation, warmth and lumpiness at the site of injection of the Fluvirin vaccine since the end of September 2002. The symptoms were self limiting and the vaccinees did not experienced sequelae from the events. The nurses administering the vaccine had received training for the proper administration of the vaccine. The reporter has assessed the relationship of the vaccine to the events as probable. Case closed, no other follow up received.									U					UNK	UNK	Concomitant Drug Not Used.		No risk factors reported.		PJP200200658	1						1	Injection site induration; Injection site inflammation; Injection site pain; Injection site warmth	FLU3~EVANS VACCINES~E33402HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233224	02/01/2005	FL	57.0	57		M	02/01/2005	10 hrs after shot, slight headache & start of stuffy sinus 24 hrs increased stuffiness and headache. 48 hrs ache in some joints, headache worse in sinus area. 72 hrs sweats and chills headache and excess mucus. 96 hrs dull headache fading, mucus decreasing, starting to feel better.									Y	01/28/2005	01/28/2005	0		UNK	UNK		none	none			1						1	Arthralgia; Chills; Headache; Hyperhidrosis; Nasal congestion; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~lh419aa~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0233226	02/01/2005	MI	44.0	44		F	02/01/2005	At 7 in the evening began having numbness, severe pain and swelling in arm.  Progressed through night and experienced nausea and vomiting, fever 101 F.  Elevated blood pressure.  At. 2 a.m. went to emergency room.  Received Benadryl and Dilaudid for pain.				Y					Y	12/17/2004	12/17/2004	0		UNK	UNK	?	No	?			1						1	Blood pressure increased; Hypoaesthesia; Nausea; Pain; Pyrexia; Swelling; Vomiting	FLU3~SANOFI PASTEUR~U1521AB~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0233227	02/01/2005	MI	50.0	50		F	02/01/2005	Within an hour of having shot arm became painful.  Took Advil, effective until Advil wore off.  Arm bad again, exercised last night.									N	01/05/2005	01/05/2005	0		UNK	UNK	Synthroid, glucophage, premerin	No	Denies	Sore arm, delerious~Td Adsorbed (no brand name)~1~0.00~In Patient		1						1	Pain	FLU3~SANOFI PASTEUR~U1569AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233235	02/01/2005	IL	1.25	1	.3	M	01/21/2005	Generalized seizures - brief - 4 times over 8 hours time starting about 24 hours after vaccinations below. Treated with anti-seizure medicine for 5 days only (Ativan). Medical Records received on 2/7/2005 states pt was stiff, shaking and fussy. Followup 02/07/05: Neurologist diagnosed as afebril seizure (new onset), with possilbe precepitation by immunization. Main symptoms were siffening and shaking, starting 26 hours after immunization. No prior seizures.					Y	5			Y	01/07/2005	01/08/2005	1	Negative CT scan of head. Negative EEG, tox screen, metabolic, amino acids, organic acids Medical records state abnormal lab tests. msv	PVT	PVT		Emesis night prior. Normal exam and well appearing on day given.	S/P removal of esophageal cyst. Medical Records received on 2/7/2005 states hernia repair and allergy.			1						1	Convulsion; Irritability; Laboratory test abnormal; Musculoskeletal stiffness; Tremor	FLU3~SANOFI PASTEUR~U1518AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0509P~3~~RL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0317P~UNK~~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0763P~UNK~~RL~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0233236	02/01/2005	WV	46.0	46		M	01/24/2005	FluMist administered 8 Jan 05 at 10:30 AM . On 11 Jan 05 cold symptoms began. Went to ER 14 Jan 05 with pain and swelling on stomach. Admitted to hospital for 4 days with Gastroenteritis leading to ileus. Discharge summary states enlarged abdomen, Medical records state diarrhea, hypovolemia. msv				Y	Y	4	Y		Y	01/08/2005	01/11/2005	3	Medical records state abnormal lab test. msv	MIL	MIL	NONE	NONE	NONE			1						1	Abdominal distension; Abdominal pain; Diarrhoea; Gastroenteritis; Hypovolaemia; Ileus; Laboratory test abnormal; Pharyngitis; Rhinitis	FLUN3~MEDIMMUNE VACCINES, INC.~500356P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0233237	02/01/2005	OR	0.58	0	.6	M	01/24/2005	Baby not using legs, fussy, not able to bear weight or move from waist down. Weakness in arms 1/24/05. Legs and arms flaccid. Follow up 03/07/05: The main symptoms of the adverse event were weakness in upper arms and flacid legs, occurring 2 to 3 days after vaccination. Patient was diagnosed with transverse myelitis. msv					Y				U	01/19/2005	01/22/2005	3	Discharge summary states lab test abnormal, csf abnormal. msv	PVT	PUB		NONE	Heart murmur (benign)			1						1	Asthenia; CSF test abnormal; Hypokinesia; Hypotonia; Irritability; Laboratory test abnormal; Myelitis transverse	DTAP~SANOFI PASTEUR~C2104AA~3~~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1473AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0145P~2~~LL~HIB + HEP B (COMVAX)~1|IPV~SANOFI PASTEUR~X1213~3~~RL~POLIO VIRUS, INACT. (POLIOVAX)~1|PNC~PFIZER\WYETH~A744MD~3~~LL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0233238	02/01/2005	NY	78.0	77		F	01/25/2005	Very strong feeling of weakness, many times of the day, almost to the point that I thought I was going to faint. It started 5 days after vaccination, and lasted for 3 weeks.									Y	11/05/2004	11/11/2004	6		OTH	PUB	Prinivil 2.5 mg twice a day					1						1	Asthenia; Dizziness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0233239	02/01/2005	NY	64.0	63		F	01/24/2005	Swelling and pain at site of administration, which spread to left arm and upper back and chest. Throbbing and burning sensation throughout arm and upper left quadrant of torso.				Y					N	01/10/2005	01/10/2005	0	N/A	OTH	PUB	Synthroid	NONE	Hoshimoto (Thyroid condition), Reactive Asthma			1						1	Injection site pain; Injection site swelling; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~01558AA~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0887P~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0233240	02/01/2005	VA	42.0	42		M	01/25/2005	Noted itching on cheeks at night. In AM reported puffiness of cheeks and an erythematous blotchy area on forehead. No raised lesions, mild excoriation from rubbing presumably. No other exposures or contact known. No shortness of breath, wheezing, throat swelling, urticaria, fever, chills, myalgia, cough or chest pain. Patient took Benadryl which helped the itching.				Y					Y	01/21/2005	01/21/2005	0	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Erythema; Pruritus; Skin irritation	FLUN3~MEDIMMUNE VACCINES, INC.~500365P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0233241	02/01/2005	HI	37.0	36		F	11/17/2004	Right deltoid pain and swelling, likely hematoma. Treated on 11/17/04.									N	11/05/2004	11/07/2004	2	NONE	PVT	PVT	Motrin	NONE				1						1	Haematoma; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1381AA~6~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233242	02/01/2005	NC	3.0	2	.8	F	01/21/2005	Mom wake up child on 01/21/05 and wrist felt warm. Visual inspection revealed multiple mosquito like bumps on arms, stomach and legs. On her buttocks was a single, large, erythematous whelp per mom. Mom states child did not have this when put to bed previous night. Also stated child look like she did when she had allergic reaction to Amoxicillin, that occurred recently. Child fuss and felt warm. Referred to primary care provider. Diagnosised as allergic reaction and treated with Zyrtec. On 01/24/05 per mom, skin clear and whelps gone.  Patient has allergy appointment on 02/08/05.				Y					Y	01/20/2005	01/21/2005	1	NONE	PUB	PUB	NONE	NONE	Amoxicillin		NC05010	1						1	Feeling hot; Hypersensitivity; Rash; Urticaria	FLU3~SANOFI PASTEUR~U1487AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0233243	02/01/2005	NC	0.96	0	1	F	01/21/2005	Patient received flu vaccine on 11/23/2004 and was diagnosed with influenza on 01/08/05 using CLIA waived flu test.				Y					Y	11/23/2004	01/08/2005	46	Positive CLIA waived Flu Test	PVT	PVT		None Known	None Known		NC05011	1						1	Drug ineffective; Influenza; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U1579AA~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0233260	02/01/2005	PA	50.0	49		F		This is a non serious spontaneous case from a consumer in the USA who experienced postnasal drip after receiving FluMist. The reporter causality is not provided. A 49 year old female experienced post-nasal drip, nasal congestion, muscle pain and abdominal pain on day after receiving FluMist on 01/04/05. The patient received the FluMist at a doctor's office where she works. The patient reported that the nurse administering the vaccines accidentally left them in the office at room temperature from the afternoon of 01/05/03, but initially thought that they can still use them. It was after 01/05/05, the patient experienced abdominal pain, which was relieved spontaneously without any intervention. She also reported post-nasal drip, nasal congestion and muscle pains for which she took Tylenol and Allegra together with herbal echinacea. The patient stated that the symptoms have since lessened. The patient has not yet recovered.									N	01/04/2005	01/05/2005	1	NI	PVT	PVT	Tylenol, Allegra and Echinacea		NI		MEDI0002686	1						1	Abdominal pain; Medication error; Myalgia; Nasal congestion; Postnasal drip	FLUN3~MEDIMMUNE VACCINES, INC.~500357P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0233261	02/01/2005	VA				M		This is a non serious spontaneous case from a consumer in the USA, involving dizziness. The reporter causality is not provided. This case is submitted according to the VAERS agreement for FluMist. An adult male reported experiencing dizziness, tiredness, stomach upset, poor appetite and difficulty in sleeping, several hours after receiving FluMist administered in a clinic at his workplace on 01/05/05. The patient did not take any medications nor did he call or visit his primary physician. On 01/06/05, he went back to the clinic and informed the nurse who administered the FluMist of his symptoms. The nurse indicated that about 130 other employees took the FluMist and he is the second person who had reported having reactions after receiving it. The patient stated that he has been receiving the flu shot for the past several years but that he had never experienced any similar reactions. On 01/07/05, he decided to stay home and voluntarily quarantined himself from his wife and 2 little children as he thought he might be contagious. The patient has not yet recovered. The reporter did not assess relationship between events and FluMist vaccination. Information from missing data report states unable to reach the reporter. No further information is available.									U	01/05/2005	01/05/2005	0		OTH	OTH	Concomitant Drug (s) Not Reported.				MEDI0002705	1						1	Decreased appetite; Dizziness; Fatigue; Sleep disorder; Stomach discomfort	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0233262	02/01/2005	OH	14.0	14		F		This is a non-serious spontaneous case from a physician in the USA who reports a patient experienced sore throat after receiving FluMist. The reporter causality was not provided.  This is a 14 year old female who experienced fever, sore throat and severely swollen lymph nodes after receiving FluMist vaccine on 12/11/04. On 12/25/04, the patient was taken to her family physician at an urgent care center and was diagnosed with mononucleosis. The patient has not yet recovered.									N	12/11/2004	12/25/2004	14	NI	OTH	OTH	Concomitant Drug (s) Not Reported.		NI		MEDI0002656	1						1	Lymphadenitis; Mononucleosis syndrome; Pharyngolaryngeal pain; Pyrexia; Viral infection	FLUN3~MEDIMMUNE VACCINES, INC.~500333P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0233263	02/01/2005	NY	11.0	11		M		This is a non serious spontaneous case from a physician in the USA of reporting a patient who developed a bacterial infection due to unspecified Steptococcus (Unlabelled, USA) after FluMist. The reporter causality is not provided. At approximately 6 pm on 12/15/04, a 11 year old male received FluMist intranasally and experienced body ache, headache, head congestion, temperature of 103 to 104 degrees Fahrenheit the following morning on 12/16/04. On 12/17/04, the patient experienced a sore throat. Throat culture at office visit revealed mildly positive streptococcal infection. The patient was treated with Zithromax. the patient has not yet recovered.									N	12/15/2004	12/16/2004	1	Strep culture mildly positive	PVT	OTH	Zithromax		NI		MEDI002643	1						1	Bacterial infection; Headache; Laboratory test abnormal; Nasal congestion; Pain; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500357P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0233264	02/01/2005	FL	58.0	58		F	02/01/2005	Developed GBS. All of a sudden fell in April 2004 and could not walk. Hospitalized untill 11/28/04. Had spinal tap to confirm GBS. Had plasmaphoresis to clear blood - 18 treatments. Currently in therapy; wearing braces on legs. Per follow up report received on 06/23/2005:  Patient's reflexes remain absent, numbness in both feet, irregular areas on both lower legs.  Right foot/ankle still unable to flex joint at all.  Needs walker and wheelchair for ambulatory efforts.  Balance remains affected, not stable when standing up - fingers are numb.  Motor skills not possible to do.  Information received from Discharge summary sttes numbness, weakness, clumsy, constipation, confusion nd elevated hemi-diaphram as symptoms; from medical records, hypotension, pin, agitation, chest pain, tachycardia. msv  Per follow up report-Right ankle still paralyzed.  APO brace required to walk. Use cane so well for short simulations. Uses wheelchair to enable independent daily living tasks in house. Still have short tremors in hands and feet associated with pain. Extremities still painful to coldness, i.e. cold weather=increased pain often disrupting sleep. Is there monetary compensation from manufacturer? Patient can not work as a result of this adverse reaction.			Y	Y	Y		Y	Y	N	10/18/2003	04/20/2004	185	Spinal tap; Blood work Information from discharge summary states abnormal lab tests, from medical records, elevated sed rate.	OTH	PVT	Lotesin; Dyazide; Neurontin; Premarin; Synthyroid; Allegra	Idiopathic Neuropathy	Augmentin; Sulfa drugs; Bioxin; Renal cell carcinoma; Nephrectomy 1994 From discharge summary, Hyperthyroid, peripheral neuropathy, depression, renal disease, cervical spinal stenosis, degenerative joint disease; from medical records, obese. msv			1						1	Abasia; Agitation; Asthenia; Chest pain; Confusional state; Constipation; Coordination abnormal; Fall; Guillain-Barre syndrome; Hypotension; Laboratory test abnormal; Myopathy; Pain; Pain in extremity; Paraesthesia; Red blood cell sedimentation rate increased; Tachycardia; Tremor; Walking aid user; Wheelchair user	FLU3~SANOFI PASTEUR~U1287AA~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0233047	02/02/2005	NJ	85.0	84		M	01/30/2005	Administered flu shot to my dad with 100.3 fever 10:30 AM 10/20/04. 10/22/04, nausea, weakness. 10/23/04, fever nausea, weakness, confusion. 10/24/04 Hospitalized, unconsciousness for 19 days. Diagnosed with Post-vaccinal encephalitis in nursing home.			Y	Y	Y	25	Y	Y	N	10/20/2004	10/22/2004	2	Permanent brain damage; Loss of memory and motor skills.	PVT	PVT	NONE	NONE	Heart bypasses, pacemaker			1						2	Asthenia; Coma; Convulsion; Dementia; Encephalitis; Hyperlipidaemia; Hypokinesia; Memory impairment; Nausea; Pneumonia; Pyrexia; Renal failure; Akathisia; Amnesia; Asthenia; Confusional state; Congenital brain damage; Encephalitis; Loss of consciousness; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~U1446AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0233314	02/02/2005	OR	2.0	2	.0	M	01/28/2005	Patient got Hepatits A vaccine on 01/20/2005 and on 01/22/2005 broke out with hives all over body and had some hoarseness.									Y	01/20/2005	01/22/2005	2	NONE	PVT	PVT		NONE	Sulfa			1						1	Dysphonia; Urticaria	FLU3~SANOFI PASTEUR~U1392AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0889P~UNK~IM~LL~HEP A (VAQTA)~1|PNC~PFIZER\WYETH~A57562E~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0233315	02/02/2005	WA	6.0			M	01/28/2005	Patient received FluMist on a Friday evening, possible 01/14/2005.  On the following Monday, possibly 01/17, patient had right leg pain that seemed to originate from his hip .  He had no fever or other current illness.  He had only very slight decrease of hip mobility.  Suspect he had a mild case of transient synovitis of the hip.									Y				NONE	OTH	PVT	NONE	No	NONE			1						1	Hypokinesia; Pain; Synovitis	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0233326	02/02/2005	CT	39.0	38		F	02/02/2005	Dizziness,  rash over forehead, face & neck.  No respiratory distress, sob. Patient received vaccine & experienced ade during employee flu clinic Employee was sent to occupational health & examined by md.  Diphenhydramine 25mg po was administered. Patient recovered				Y					Y	12/14/2004	12/14/2004	0		UNK	UNK			Patient has received flu vaccines in previous years.			1						1	Dizziness; Encephalitis; Rash	FLU3~SANOFI PASTEUR~41532AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0233331	02/02/2005	CT	67.0	67		F	02/02/2005	About three hours after receiving the vaccine, the person had some lower lip and chin numbness. Patient had flu shots in the past with no problems. Recommend she go to the E.R. She went to an emergency clinic and the physician said she had a mild anaphylactic reaction. At this point did have facial swelling. She was treated. Follow-up call to this person the next day found her to be fine. Follow up report received on 04/28/2005:  Allergic reaction related to Motrin allergy.				Y					Y	01/07/2005	01/07/2005	0		UNK	UNK		None. Has only allergist in the area.				1						1	Anaphylactic reaction; Face oedema; Hypoaesthesia	FLU3~SANOFI PASTEUR~U1516AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0233332	02/02/2005	VA	11.0	10		F	02/02/2005	Vaccines given 12/6/04. On 12/7/04, Mom reported fever of 101.0 F and right arm was swollen. Seen in ER, no tx, ER MD told Mom normal reaction to pneumococcal vaccine. 12/10/04-- nurse contacted and advised area of swelling size of softball and arm hurting.  Referred to PMD that day & prescribed Keflex for cellulitis secondary to pneumococcal vaccine, improvement noted within 24 hours of starting antibiotic, with continued improvement noted on 12/13/04.				Y					Y	12/06/2004	12/07/2004	1	CBC & blood cultures done -- results unavailable.	UNK	UNK	none	none	Patient was undergoing work up for immunodeficiency and vaccines were requested by MD based on non-protective titers to H Influenza, Strep pneumonia and tetanus.			1						1	Cellulitis; Pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U145AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~U0842AA~1~IM~RA~HIB (ACTHIB)~1|PPV~MERCK & CO. INC.~0490P~1~SC~RA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~UE228AB~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0233334	02/02/2005	CA	1.01	1	.0	F	02/02/2005	CHICKENPOX LESIONS APPEARED A FEW DAYS AFTER VARICELLA VACCINE WAS GIVEN.  PT DID NOT PRESENT TO MEDICAL UNTIL LESIONS HAD RESOLVED.									Y	01/18/2005	01/26/2005	8	NONE	MIL	UNK		NONE	NONE			1						1	Drug ineffective; Skin ulcer; Viral infection	FLU3~SANOFI PASTEUR~U1472AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~GLAXOSMITHKLINE BIOLOGICALS~0070N~UNK~IM~LL~HIB (HIBERIX)~1|MMR~MERCK & CO. INC.~1300N~UNK~IM~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0279P~UNK~IM~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0233337	02/02/2005	MO	53.0	52		M	02/02/2005	Within a day of the flu shot, I began experiencing and continue to experience constant pain and tingling in my left hand ring finger. Patient reported to RN on 02/02/05, states he has intermittent pain and tingling in left ring finger, started in left middle ring and pinky fingers. Now it is just in the ring finger and severity is decreased. However, is noticeable most of the time per patient. Patient was advised to contact PMD for neurological exam.									N	01/24/2005	01/25/2005	1	NONE	UNK	UNK		NONE				1						1	Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U1497AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233338	02/02/2005	CA	47.0	46		M	02/01/2005	Two weeks after flu vaccine given, complained of left side facial droop. Diagnosed as Bell's Palsy by ER physician. Prednisone 60mg po q d for 5 days ordered, then 40mg for 2days, then 30mg for 2 days, then 20mg for 2 days, then 10mg for 2 days and then 5mg for 2 days. Referred to a neurologist. Also given Acyclovir 400mg po bid for 7days and Ibuprofen. 12/06/04, somewhat improved.				Y					U	11/16/2004	11/30/2004	14		OTH	PUB	Prednisone, Albuterol, Hydroxyzine, Fluoxetine	Asthma Hepatitis C	Asthma, psychological history			1						1	Facial palsy	FLU3~SANOFI PASTEUR~U1519AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0233339	02/02/2005	LA	7.0	7		M	02/02/2005	Presented to PER, 1 day after discharged from hospital for asthma exacerbation and receiving a flu shot for the first time. Mom noticed rash to both arms and stomach at home on 02/02/05. Came to pediatric emergency room with rash and hives to body. Given Benadryl, no fever reported.				Y					Y	02/01/2005	02/02/2005	1	NONE	PUB	OTH	Albuterol	Asthma	None			1						1	Condition aggravated; Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0233340	02/02/2005	TN	2.0	2	.1	M	01/27/2005	Screaming and jerking episodes about 1 to hours after administration of vaccine. (Second vaccine given about 2 weeks after 1st flu vaccine) Follow up 02/07/05: Child did not die, Clinic will fax EEG report.									U	01/20/2005	01/20/2005	0	Rule out seizure disorder, EEG scheduled.	PVT	PVT	NONE	NONE	Asthma			1						1	Dyskinesia; Screaming	FLU3~SANOFI PASTEUR~U1536AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233336	02/03/2005	MO	8.0	7		F	02/02/2005	Mother states client broke out into hives on 1/22/05. She still had hives on 01/31/05 so she took her to the doctor and he said it was from the FluMist. Client seen by Dr.				Y					U	01/19/2005	01/22/2005	3	NONE	OTH	OTH		NONE	NONE			1						1	Urticaria; Pruritus; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500339P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500339P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Emergency room visit	Influenza
0233355	02/03/2005	MA	65.0	65		M	12/14/2004	Right arm swelling, felt warm, took Naprosyn with relief of pain. Two days later very swollen, went to ER. The ER physician diagnosed as cellulitis and treated with IV Leviquin for 3 days then po for 7 days. Also had blisters. Saw dermatologist 5 days after the incident for routine check up, he felt that patient had had an allergic reaction to the vaccine.				Y					Y	12/09/2004	12/09/2004	0		PUB	PUB	Diovan, Triamterene, Proscar	NONE	Allergies: PCN, Zestril , Hypertension		MA0S02	1						1	Blister; Cellulitis; Hypersensitivity; Oedema peripheral; Pain; Vasodilation procedure	FLU3~SANOFI PASTEUR~U1555AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0287N~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0233358	02/03/2005	IL	5.0	4		F	01/27/2005	Mom reported 24 hours post immunization patient had  involuntary head jerking. Took child to doctor, nothing found as to cause the head jerking. Mom states it is starting to subside.				Y					U	01/18/2005	01/19/2005	1		PVT	PUB		None Known	None Known			1						1	Dyskinesia	DTAP~GLAXOSMITHKLINE BIOLOGICALS~622A~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1439AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X0706~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0323P~2~SC~RA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|VARCEL~MERCK & CO. INC.~0763P~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0233359	02/03/2005	MO	82.0	82		F	01/26/2005	Patient reports adverse event as therapist told her to do so.  She reports a severe headache on the evening of 12/03/2004 and by 12/04/2004 she went to the ER. By this time was experiencing pain and swelling in left arm that required to be ice packed for 1.5 days. She is currently in therapy for her left arm. Reports no more headaches and improving left arm.				Y	Y	6			Y	12/03/2004	12/03/2004	0	Talked to doctor who relates he cannot say with certainty flu injection caused this, slight possiblity, no evidence of bacterial infection or arthiritis. As for patient receiving again that is up to her. Dr. relates patient has multiple medical problems.	UNK	UNK			Sulfa, Polyarthiritis, CAD, DM, Aortic Bypass August of 2002. Medical record states hx of stroke.		MO2005004	1						1	Headache; Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~U1555AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0233364	02/03/2005	CA	1.04	1	.0	M	02/03/2005	Patient with episodes described by parent as shaking (startling) of body lasting up to 30 seconds during which the patient was not responsive to name being called. Mother of child reports that during each episode patient was noted to have fever. The fever and shaking episodes started 6 days after MMR and varivax given.				Y					Y	01/24/2005	01/30/2005	6	Urinalysis, cbc, blood culture all negative	UNK	UNK	no	No	NA			1						1	Coma; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U1417AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~UNKNOWN MANUFACTURER~0322P~1~SC~LL~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~0581P~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0233365	02/03/2005	FL	78.0	77		M	02/03/2005	Pain in arm at injection site began on 1/18/05. Spread to thigh muscles, feet, hands. Pain keeps moving, but is not improving.  Has prostate inflammation so went to urologist on 2/3/05, but urologist said pain is not related to prostate. Will see primary MD on 2/5/05. Is taking Ibuprofen for pain. Also has fatigue.				Y					N	01/12/2005	01/18/2005	6		UNK	UNK	Cipro BID for prostate inflammation. Actopril and Norvasc for high blood pressure.	Inflammation of prostate	High blood pressure			1						1	Fatigue; Injection site pain; Myalgia; Pain in extremity; Prostatic disorder	FLU3~SANOFI PASTEUR~~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~~1~~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0233366	02/03/2005	WI	82.0	82		M	10/20/2004	911 was called, patient symptoms were pale, weak, dizzy, nausea, headache and blurred vision. ER notes stated normal EKG, released with diagnosis of possible reaction to flu shot.				Y					Y	10/19/2004	10/19/2004	0	EKG- Normal cardiac symptoms ruled out.	PUB	PUB	Glyburide, Amidrone, Digoxin, Detrol, Furosemide	None	Heart disease, HTN, CHF, stroke hx, diabetic, Bypass surgery, depression hx.			1						1	Asthenia; Dizziness; Headache; Hypersensitivity; Nausea; Pallor; Vision blurred	FLU3~SANOFI PASTEUR~U1380AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0233367	02/03/2005	WI	75.0	74		F	10/26/2004	Patient appeared at health department on 10/29/04, complaining of sore right arm at injection site, fever, loss of appetite, lightheadness and complete exhaustion.									Y	10/21/2004	10/21/2004	0	NONE	PUB	PUB		NONE	NONE		WI0504	1						1	Anorexia; Dizziness; Fatigue; Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~U1380AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1138N~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0233373	02/03/2005	GA	1.01	1	.0	M	02/03/2005	Patient was found this afternoon cold and not breathing.  His resuscitation was not successful.  Autopsy report received stated COD was SIDS.	Y	02/03/2005							N	02/01/2005	02/03/2005	2	Autopsy is pending	UNK	UNK	none	Upper respiratory infection	None			1						1	Apnoea; Hypothermia; Sudden infant death syndrome	FLU3~SANOFI PASTEUR~41580AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0608P~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0765P~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Results in Death	Influenza
0233376	02/03/2005	MA	1.03	1	.0	M	02/03/2005	Temperature of 103 degrees, 5 1/2 hours after vaccine. Follow up report received 02/09/2005: states child's fever resolved in a few hours, and fine since.									Y	02/03/2005	02/03/2005	0	NONE	OTH	PUB	NONE	NONE	NONE			1						1	Pyrexia	FLU3~SANOFI PASTEUR~41452AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0467P~1~SC~LL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|VARCEL~MERCK & CO. INC.~0767P~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0233377	02/03/2005	CT	48.0	48		F	02/01/2005	Regional lymphadenopathy, left supraclavicular adenopathy on lateral side of vaccination.									U	01/27/2005	01/31/2005	4		PVT	PUB	NONE	NONE	Allergies to sulfa, PCN, none to vaccine components.	Adenopathy~DT Adsorbed (no brand name)~~23.00~In Patient	CT200501	1						1	Lymphadenopathy	FLU3~SANOFI PASTEUR~1479AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233378	02/03/2005	AK	1.68	1	.7	M		Cellulitis right anterior thigh verses Varivax reaction. PCV7 and Varivax given in right lower extremity, with initial local erythema and swelling, which significiantly increased. Seen 01/07/05, given a prescription for Keflex 50 mg po, condition improved.				Y					Y	01/05/2005	01/05/2005	0		PVT	PUB	NONE	NONE	NONE		AK220535	1						1	Cellulitis; Injection site erythema; Injection site swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~639A2~4~IM~~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U141AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A83578H~4~IM~~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0331N~1~SC~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0233375	02/04/2005	AZ	49.0	48		F	02/04/2005	Since 2 weeks after the vaccine- I have increased asthma problems, severe reactions to anything with any corn or corn derivitives- to the point of anaphaxis- and needing epinephrine almost daily. I have now been referred due to the severity of the reactions and the numbers of them. 60 Day Follow up: Con't to have problems with anything made from any type of corn or derivatives-thermisel, cornstarch, dextrose. Information from medical records state sneezing, itching as symptoms. msv Per follow up report-Continue to go into anaphelaxis with any exposure to corn products-especially popcorn or any derivative of corn including gellatin.			Y	Y					N	10/03/2004	02/01/2005	121		UNK	UNK	estradiol 1mg	none	mild asthma Information from Medical records states allergic reactions, contact dermatitis. msv			1						1	Anaphylactic reaction; Anaphylactic reaction; Asthma; Condition aggravated; Hypersensitivity; Pruritus; Rhinitis	FLU3~SANOFI PASTEUR~U1462AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0233381	02/04/2005	MI	12.0	11		M	02/04/2005	Received vaccine (mist) at 4pm on 2/2.  On 2/3 at 10:40 am, began to feel light-headed and queasy while sitting in class.  5 minutes later, fainted and fell to floor.  Dazed upon being revived.  Felt very ill for next hour (shaky, nauseaous, numb legs and arms [tingly, unsteady], dizzy).  At 24 hours since first reaction, continues to have sore muscles throughout body especially legs & arms, and runny nose, unsteady physically, balloon head.									U	02/02/2005	02/04/2005	2		UNK	UNK		Had been dealing with stomach complaint which is going around school (sore stomach)-- off & on but that morning had felt well.	epidermolysis bullosa			1						1	Dizziness; Fall; Hypoaesthesia; Malaise; Myalgia; Nausea; Paraesthesia; Rhinorrhoea; Syncope; Tremor	FLUN3~MEDIMMUNE VACCINES, INC.~500333P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0233392	02/04/2005	MO	1.27	1	.3	F	02/01/2005	Child developed urticaria within 24 hours of vaccine administration.									Y	01/26/2005	01/27/2005	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1569AA~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233396	02/04/2005	FL	76.0	76		F	01/26/2005	Patient received flu and pneumonia vaccines on 01/21/05. On 01/25/05 her blood pressure was high and today it is 200/100 and she has dizziness. She called her doctor that manages her HTN,  who instructed her to take additional medication. I explained to the patient that my knowledge the flu and pneumonia vaccines should not cause your blood pressure to elevate, but that she could have soreness and tenderness of the area, which she indicated she did. I advised client to recall her BP doctor, if unable to reach them go to ER, as she attempted to recheck her BP during our conversation and her machine stated twice that it was unable to read. I notified my supervisor.									U	01/21/2005	01/24/2005	3		PUB	OTH		NONE	NKA			1						1	Condition aggravated; Dizziness; Hypertension; Pain	FLU3~SANOFI PASTEUR~U1549AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0531P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0233397	02/04/2005	NY	72.0	72		M	01/29/2005	1. Got the Flu 1 day after vaccination. Treated with Augmentin and Ampicillin. 2. Got the mumps 7 days after vaccination, treated with IV steroids in emergency room, followed by 6 days of oral methylprednisolone. 3. As of 01/29/05 still not fully recovered. Follow up 02/15/05: Vaccination given at another facility, manufacturer and lot number for vaccine not available.				Y					Y	01/03/2005	01/04/2005	1	2 Blood tests, one in emergency room on 01/10/05 and one at quest labs on 01/12/05.	PUB	OTH	Afeditab 30mg and Synthroid 150mcg	NONE	Hypertension and a Thyroid Nodule			1						1	Drug ineffective; Infection; Influenza; Viral infection	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0233398	02/04/2005	NY	71.0	70		F	01/29/2005	Had the flu that was treated with Zithromax. Follow up 02/15/05: Information on manufacturer and lot number of vaccine not available, vaccinated at another facility.				Y					Y	01/03/2005	01/06/2005	3	NONE	PUB	OTH	Calan SR, Tamoxifen, Maxzide, and Lipitor	NONE	Hypertension and elevated cholesterol			1						1	Drug ineffective; Influenza	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0233399	02/04/2005	NM	1.0	1	.0	F	01/07/2005	Patient broke out in chicken pox 15 days after vaccination.				Y					Y	12/16/2004	12/31/2004	15	NONE	PVT	PUB		NONE	NONE		NM022005	1						1	Infection	FLU3~SANOFI PASTEUR~U1484AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0320P~1~SC~LL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|VARCEL~MERCK & CO. INC.~0650P~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0233414	02/04/2005	AZ	1.26	1	.3	M	02/01/2005	Reports child had 2 lesions approx 1/25/05 - one on leg, 1 on trunk.  Now has 4 lesions in different areas.  First one is scabbed over.  Red, raised, w white center.  Started nausea & uncontrollable vomiting last night & has vomited today also but not uncontrollably, denies fever.  Advised to contact PCP, encouraged fluids & no ASA									Y	01/11/2005	01/25/2005	14		UNK	UNK			None		AZ0503	1						1	Nausea; Rash erythematous; Skin ulcer; Vomiting	FLU3~SANOFI PASTEUR~U1468AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A67180C~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0116P~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0233416	02/04/2005	CA	6.0	6		F	02/04/2005	RASH OF LEFT DELTOID/ALLERGIC REACTION TO FLU SHOT PER DR. HYDROCORTIZE 0.5% BID X 7 DAYS PER DR. NO FLU SHOTS.				Y					Y	01/31/2005	02/03/2005	3		UNK	UNK	NONE	NONE/HX ASTHMA	AUGMENTIN-RASH/AMOXICILLIN-RASH KEFLEX-RASH			1						1	Hypersensitivity; Rash	FLU3~SANOFI PASTEUR~U1553AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0233431	02/07/2005	TX	14.0	13		F	02/07/2005	Dec 2nd my daughter complained of lower leg pain.  After sleeping 5 hours she woke with both lower legs completely numb.  We went to her pediatrican who thought she had GBS and sent us to a pedi neurologist.  She had tingling before the next upper part of her body would go numb.  By Friday AM she was numb from the waist down.  Neurologist had her admitted to the hospital.  They did tests and eventually did the spinal tap on the 6th day as the feeling was beginning to return in her legs.  The numbness made it way up to get below her chest and the tingling was from her chest to her head.  She spent 6 days in the hospital.  She didn't return to school until January and even then her legs would still be painful when she became too tired.  Her cheeks and ears become red and then she starts to complain about her legs hurting.  She hasn't complained about her legs now in about 2 weeks. 60 Day Follow up: When she becomes really tired her cheeks and ears become bright red. If the tiredness is extreme then her legs and arms will start tingling and hurting. Information received from annual follow up letter states when really tired, patient's ears and sometimes cheeks turn red.				Y	Y	6	Y		N	11/19/2004	12/02/2004	13	CAT scan, blood work, spinal tap, EEG (needles placed in the muscles of the legs and then a shock sent up through her spine)	UNK	UNK	Keflex Cap 500 mg  Metrogel Gel 0.75%	An ingrown toe nail and some acne around her nose.	None			1						1	Erythema; Fatigue; Flushing; Hypoaesthesia; Pain; Paraesthesia	FLUN3~MEDIMMUNE VACCINES, INC.~50034P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0233436	02/07/2005	OH	62.0	62		M	02/07/2005	Woke Friday, 2/4/05, morning with stiff neck and head ache, continued throughout Saturday, 2/5/05 and Sunday, 2/6/05. Symptoms are improving today 2/7/05.									Y	02/03/2005	02/04/2005	1		UNK	UNK	Prevecid	GERD	Allergy PCN			1						1	Headache; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U1528AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233439	02/07/2005	AK	22.0	22		M	02/07/2005	Headache, weakness, rash over body, difficulty sleeping since 31 January 05. Pt visited doctor on 3 Feb 05.				Y					U	01/31/2005	01/31/2005	0	Rash	MIL	MIL	None	Headache and vomiting	none		AK200538	1						1	Asthenia; Headache; Insomnia; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500367P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0233440	02/07/2005	AK	62.0	62		F	02/07/2005	C5-C6 transverse myelitis. Information from medical records states numbness, paralysis, Urinary retention and neurogenic bowel.					Y	21			U	11/24/2004	01/10/2005	47	Cervical spine MRI. Negative lumbar spinal tap.	MIL	OTH	Coumadin Digoxin  Glipizide Lantus insulin Rabeprazole  Advair MDI Flonase nasal spray Combivent inhaler  Cetirizine  Sertraline  Simvastatin Levothyroxine	Recovering from bronchitis	COPD/asthma Type 2 DM Chronic atrial fibrillation Hyperlipidemia Information from transfer summary states brain atrophy, chronic ischemic leukoencephalopathy, throasic spondylosis, Hypothyroid; from medical records, hypertension, obesity, depression, arthritis GERD and heart disease.		AK200542	1						1	Myelitis transverse; Neuropathy; Paraesthesia; Paralysis; Urinary retention	FLU3~SANOFI PASTEUR~U1515AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0233445	02/07/2005	TX	37.0	37		M	01/08/2005	Two hours after immunization, patient developed redness and swelling of MCP joints of hands; blotchy erythematous rash from hands to elbows; erythema to face neck and ears. Symptoms lasted approximately 8 hours, went away after taking Benadryl.									Y	01/08/2005	01/08/2005	0	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Erythema; Joint swelling; Rash erythematous	FLUN3~MEDIMMUNE VACCINES, INC.~500365P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0233447	02/07/2005	WA	1.59	1	.6	M	12/22/2004	Patient received influenza vaccination 11/08/04, two days later developed a rash on limbs and buttocks that later spread to the face. Morphology ultimately consistent with Gianotti-Cresti.				Y					Y	11/08/2004	11/10/2004	2	Skin culture, CBC, AST/ALT, ALk PH=3, Bilirubin, Rapid Strep Screen- All negative	PVT	UNK	N/A	NONE	NONE	Fever 105~Measles + Mumps + Rubella (no brand name)~1~1.40~In Patient		1						1	Rash	FLUX~UNKNOWN MANUFACTURER~U10404AA~3~~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0233448	02/07/2005	MA	53.0	52		M	02/01/2005	Developed cellulitis at site of pneumococcal vaccine with redness, warmth and local induration.									Y	01/27/2005	01/28/2005	1	WBC 12.4	PVT	OTH	NONE	NONE	Hyperlipidemia			1						1	Cellulitis; Injection site erythema; Injection site induration; Injection site reaction; Injection site warmth	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0486P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0233449	02/07/2005	KY	1.17	1	.2	M	02/04/2005	Mom reported child developed difficulty walking with both legs in the PM of 2/3/05. Cried excessively and appeared to be pain in both thighs. No fever.									U	02/03/2005	02/03/2005	0		PUB	PUB	NONE	NONE				1						1	Crying; Hypokinesia; Pain	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A001AA~1~~~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1439AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0717N~3~~~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~A57560H~3~~~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0117P~1~~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0233450	02/07/2005	TX	11.0	10		F	02/02/2005	At 12:50 am on 02/02/05, complained ears hot; rashy, splotchy, red and white over face, arms elbows and hips. Afebrile per mom. Called physician and was told to give Benadryl. Symptoms eased then patient said her throat was tight. 2:00 p.m. on 02/02/05, ok but says still feels tightness in throat.									Y	02/01/2005	02/02/2005	1	N/A	PUB	UNK	Zicam, Singulair, Rhinocort	Sinus congestion	Multiple allergies ( pollen, dander, rag weed)			1						1	Ear disorder; Feeling hot; Rash macular; Rash maculo-papular; Throat tightness	FLU3~SANOFI PASTEUR~U1439AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1219N~3~IM~LA~HEP B (FOREIGN)~1	USA		Influenza
0233451	02/07/2005	IN	62.0	62		F	02/01/2005	Patient called and reported waking up next morning (1/24/05) feeling disoriented, dizzy and unable to function as normal. Husband took her to the ER, BP was high (170/102). Diagnosed with Transient global amnesia. By 11:30 a.m., patient was feeling back to normal, BP returned to 120/83. There is a reddened hard area where injection was given. Follow up test such as EKG were done at doctors office and all were fine. Was prescribed Keflex by ER physician.				Y					Y	01/26/2005	01/27/2005	1	EKG- Fine	PUB	PVT		NONE	NONE			1						1	Amnesia; Disorientation; Dizziness; Hypertension; Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U1569AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0233479	02/07/2005	AK	26.0	26		M	02/07/2005	2 Days later face swelled with red dots no itching.									Y	01/31/2005	02/02/2005	2	N/A	MIL	MIL	None	None	None		AK200539	1						1	Erythema; Face oedema; Pruritus; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500367P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0233486	02/07/2005	CA	14.0	14		M	02/07/2005	Developed severe tics 9 days after administration of the vaccine.  given Inderol, 10mg. to try to decrease the frequency.  Were occurring at rate initially of up to 20 per minute.  4 months later, occurring 1 every 4 minutes or so, more under stress. Was enrolling in High school of the arts for music and is now unable to attend. 60 Day Follow Up: Is still having severe tics, now being treated by Halodol. Per follow up report-Continues to have tics, usually at the rate of 1 or 2 per minute instead of many per minute. Under stress they continue at the rate of as many as 15 per minute.				Y				Y	N	11/18/2004	11/27/2004	9	He is scheduled for MRI/cat scan with pediatric neurologist 2/18/05.	UNK	UNK	None	None	Allergies to penicillin. Information from medical records states attention deficit doisprder, aspergers syndrome. msv	neurological problems~Hep B (no brand name)~2~0.20~In Sibling|Neurological problems~Hep B (no brand name)~2~0.20~In Sibling		1						1	Tic	FLU3~SANOFI PASTEUR~U1410BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~UNKNOWN MANUFACTURER~~3~IM~RA~HEP B (NO BRAND NAME)~1	USA	Disabling	Influenza
0233488	02/07/2005	CA	63.0	63		F	02/01/2005	Large (90mmx50mm) on Left deltoid consisting of swelling and erythema. Fluzone 0.5cc was given at this site on 01/21/05. The above described problem developed on 1/24/05.									Y	01/21/2005	01/24/2005	3	NONE	PUB	PUB	NONE	NONE	Zithromax		CA050003	1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1410RA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233489	02/07/2005	IN	46.0	46		F	02/07/2005	2/4/05 Left deltoid red, swollen and sore, c/o body aches.									U	02/02/2005	02/03/2005	1	referred to PCP	PVT	OTH	Synthroid, Imitrex, Esnace, Mysoline, Crestar, Procio, Excedrin	UNK	Allergic to Tegratol, Dilantin			1						1	Injection site erythema; Injection site oedema; Injection site pain; Myalgia	FLU3~SANOFI PASTEUR~1277~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233495	02/08/2005	UT	63.0	63		F	02/02/2005	On 12/30/04 developed back pain. 1/2/05: facial and leg paralysis. Guillain Barre diagnosis.   4/7/05 Discharge summary received for 1/2-1/7/2005 & states fever, chills, myalgia, sore throat, cough, flu syndrome, headache, right side facial droop, slurred speech, constipation, urinary retention, difficulty swallowing, weakness, numbness, tingling, decreased reflexes.  Tx w/IVIG, improved slowly & transferred to inpt rehab.  60 Day Follow Up: speech problems have cleared up. Residual right leg weakness. Per annual follow up report-Residual weakness in leg, more fatigue than in past. Has been able to return to driving and working full time.				Y	Y	26			N	10/19/2004	12/30/2004	72	CSF Protein 119 (H).	PVT	PVT	UNK	UNK	From discharge summary states depression, migraine, osteoporosis, GERD, hyperlipedemia and back pain as prior health problems.			1						1	Asthenia; Back pain; CSF test abnormal; Chills; Constipation; Cough; Dysarthria; Dysphagia; Facial palsy; Fatigue; Guillain-Barre syndrome; Hypoaesthesia; Hyporeflexia; Influenza; Muscular weakness; Myalgia; Paraesthesia; Paralysis; Pharyngolaryngeal pain; Pyrexia; Urinary retention	FLU3~SANOFI PASTEUR~U1449AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0233496	02/08/2005	TX	38.0	37		F	01/23/2005	Received Flumist nasal vaccination on 01/11/05. On 01/12/05 awoke with diarrhea and headache. After the diarrhea subsided, stomach was achy all day with persistent nausea x3days. At end of first day (01/12/05) +vomiting x1.									U	01/11/2005	01/12/2005	1		UNK	UNK	Allegra (180mg), Liquibid D, Day 6 of Zithromax pack 2 , sinus infection					1						1	Abdominal pain upper; Diarrhoea; Headache; Nausea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0233497	02/08/2005	NY	12.0	12		M	02/03/2005	1 hour after shot hives, face and lips, feel like something crushing chest. Coughing, slight wheezing.				Y					Y	02/02/2005	02/02/2005	0		PUB	PUB		NONE	Asthma			1						1	Chest discomfort; Cough; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U1553AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0233498	02/08/2005	CA	54.0	53		F	11/03/2004	2 1/2 inch round red circle around injection site. Slightly warm and tender day after shot. ? If was a reaction (have had flu shot for 10 years)									Y	10/29/2004	10/30/2004	1		PVT	OTH						1						1	Feeling hot; Injection site erythema; Tenderness	FLU3~SANOFI PASTEUR~U1500AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233499	02/08/2005	ID	55.0	54		F	02/04/2005	Pt complaining of very painful arm and numbness; pain is also radiating into neck. Pain started within a couple hours of the shot and is still persisting a month later. She saw her doctor and he told her the shot hit her radial nerve, and has recommended physical therapy and referred her to a neurologist.				Y					N	12/31/2004	12/31/2004	0	UNK	OTH	PVT	UNK	NONE	UNK			1						1	Hypoaesthesia; Injection site pain; Medication error; Neck pain	FLU3~SANOFI PASTEUR~U1504AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0233500	02/08/2005	ID	59.0	59		F	02/03/2005	Approx 1 wk following injection developed rash on chest progressing up neck to face, eyes, forehead. Intense burning in throat, nose, eyes. Pt did not seek help until around Christmas. Saw eye doctor rx for betamethasone. Which worsened reaction. Referred to dermatologist. Patch test shows allergy to thimerosal. Treatment with steroids, pt reported allergy to pharmacist on 02/03/2005.									U	11/12/2004			Patch test positive for thimerisol	OTH	OTH	UNK	NONE	Allergies: Poss Aspirin, Penicillin			1						1	Burning sensation mucosal; Eye irritation; Hypersensitivity; Laboratory test abnormal; Pharyngitis; Rash	FLU3~SANOFI PASTEUR~U1440AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233552	02/08/2005	CA	1.11	1	.1	M	01/31/2005	Approx 12 hr after receiving 12's child became febrile (103 R) and irritable x 13 hrs and again the next night. Parent gave Advil gtts Q6H. Afebrile during daytime.									Y	01/26/2005	01/26/2005	0		PUB	PUB	NONE	NONE	NONE		CA050004	1						1	Irritability; Pyrexia	FLU3~SANOFI PASTEUR~U1484AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0042P~1~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~495719~4~IM~~PNEUMO (PREVNAR)~1	USA		Influenza
0234625	02/08/2005	WA	59.0	58		M	02/08/2005	Patient came into clinic for Flu shot appointment.  After inputing information for Flu shot into computer, patient began reading VIS on my desk about the Intranasal Flu Vaccine.  He asked about SE and cost.  I informed him of this information.  I asked if he had any medical problems and he stated no.  He continued to read the information as I changed the information in the computer to give him Flu Mist.  While doing this, I did not check his age.  Then....I inadvertently gave Flu Mist intranasal flu vaccine to him - a 58yo who was above the 49yo limit for this vaccine.  After he left the Clinic, I realized my mistake and began reporting procedures to the Immunization Coordinator for Public Health  and then called the patient to apologize.  The coordinator checked with CDC and was informed it would be okay for the patient to receive the Flu shot despite just getting Flu Mist.  We offered that to the patient, but he has not yet responded and may wait the 2 weeks as recommended on the Flu Mist web site.  At this point, he has not reported any adverse SE to the Flu Mist vaccine.									U	02/07/2005			None	UNK	UNK	None	None	None			1						2	Medication error; Myalgia; Nasal congestion; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~IN500335P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~5003550~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0201690	02/09/2005	WI	43.0	43		F	02/09/2005	WAS GIVEN ANTHRAX SHOT (3RD ONE) AND SMALL POX AND 3 OTHER SHOTS ON MAR 23, 2003 AND HAD STROKE (BRAIN STEM STROKE) ON MAR 28,2003.  WAS PUT ON MEDICAL HOLD AND PROCESSED OUT OF SERVICE ON TDRL.				Y				Y	N	03/21/2003	03/28/2003	7	MRI - CONFIRMED BRAINSTEM STROKE.  BLOOD TEST CONFIRMED C-REACTIVE PROTEIN (HIGH)	MIL	MIL	VIOXX PREMARIN	NONE	HEART MURMUR, RHEUMATOID ART,			1						2	Cerebrovascular accident; Laboratory test abnormal	ANTH~EMERGENT BIOSOLUTIONS~~3~~~ANTHRAX (BIOTHRAX)~2|DTPIHI~UNKNOWN MANUFACTURER~~UNK~~~DT+IPV+HIB+HEPB (NO BRAND NAME)~2|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~2|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~2	USA	Disabling	Influenza
0233565	02/09/2005	MD	7.0	7		F	02/08/2005	Left arm pain reported since receiving the flu shot (reported to health department 2/4/05). During follow up call, 2/7/05, from health department, Dad states child was evaluated and hospitalized. Medical Record received on 2/14/2005 states fever, decreased mobility and edema. 60 Day follow up: we have had no additional contact from childs family.				Y	Y				U	01/26/2005	01/27/2005	1	UNK	PUB	PVT	UNK		Medical Record received on 2/14/2005 states flu.			1						1	Hypokinesia; Oedema; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1530AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0233566	02/09/2005	WA	62.0	61		F	01/08/2005	Pain in muscle of upper arm and forearm; spread to general muscle aches over the rest of body, approx 10 days after getting shot. Now after 3 weeks, Pain is localized in upper arm muscle (took Advil)				Y					Y	12/19/2004	12/20/2004	1		UNK	PVT		NONE	NONE		WA052087	1						1	Injection site pain; Myalgia	FLU3~SANOFI PASTEUR~U1500AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0233575	02/09/2005	TX	40.0	40		M	02/09/2005	I received the mist at approximately 1415 hours.  I was not directed to keep my head tilted back, the mist began to run out my nose.  I stopped it from running using my right pointer finger.  The drug saturated my cortical area.  About 3 hours later the area surrounding my fingernail turned a slight red color, began to feel warm and had a slight pain.  At approximately 0300 hours the next day, the finger (two end digits) were a darker red color, swollen, hot, with a throbbing pain.  Bending the finger was difficult and gently touching the area cause considerable pain.  I soaked the finger in H2O2 for about 5 minutes, then put a triple antibiotic on it and put a band aid over it.  As of today 3 days later, the finger is a little better, still warm, pink in color, and sensitive to touch.  I have been keeping a band aid on it with a triple antibiotic.									U	02/07/2005	02/07/2005	0		MIL	MIL	None	None	None			1						1	Erythema; Feeling hot; Hypokinesia; Oedema peripheral; Pain	FLUN3~MEDIMMUNE VACCINES, INC.~500356P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0233588	02/09/2005	CA	2.0	2	.1	F	02/09/2005	swelling and redness to left upper arm.  Ice and Motrin per grandmother.				Y					U	02/07/2005	02/09/2005	2	n/a	UNK	UNK	NONE	GRANDMOTHER STATES CHILD HAS SEASONAL ALLERGIES	NONE			1						1	Erythema; Swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~632a2~4~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~u1519ab~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~818a2~1~IM~RA~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~818a2~4~IM~LA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0233597	02/09/2005	MO	0.67	0	.7	M	01/28/2005	Mother stated to RN that patient developed a fever of 103 for 24 hours with administration of Tylenol and Motrin as well as uncontrollable crying. Mother did state prior to shots patient did have Rosella, but was recovered from illness before getting immunized.									Y	12/21/2004	12/21/2004	0		UNK	UNK	Unknown	Rosela  before immunization	None Known		MO2005007	1						1	Crying; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A007AA~2~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1473AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0224P~2~IM~LL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~A57560H~2~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0233600	02/09/2005	FL	60.0	60		U		Pt states within first hour of receiving vaccine she felt pain at injection site and throughout the arm.				Y					N	01/25/2005	01/25/2005	0	NONE	PUB	PUB	Celebrex 200mg 2-3x, Tegretol 200mg, Fosamax	NONE	Left side hemiparalysis, osteoarthritis, rheumatoid arthritis, neuropathy.			1						1	Injection site pain	FLU3~SANOFI PASTEUR~1552AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0986N~7+~IM~RL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0233601	02/09/2005	CA	66.0	66		F	02/09/2005	Fever (100.5), chills, welts on arm and body specifically left side where I had both flu and pneumonia shots. Arm red and very swollen 1 week. Spent 2 days in bed sleeping. Acute abdominal distress began on 3rd day. Still recovering from both.									Y	11/10/2004	11/11/2004	1	Had ultrasound of abdomen and pelvic areas negative	OTH	PUB	Levothyrskin 81mg, Aspirin, Xalatan, ICAP, Painfree, multivitamin/mineral	NONE	Amoxicillin, positive TB skin test, reaction to INH treatment			1						1	Abdominal discomfort; Chills; Injection site erythema; Injection site oedema; Lethargy; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~7+~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~~~PNEUMO (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0233612	02/10/2005	LA	6.0	5		F	01/19/2005	NONE STATED Follow up 02/14/05: Henoch-Schonlein Following vaccination.					Y	2			Y	10/26/2004	10/28/2004	2		PVT	UNK						1						1	Henoch-Schonlein purpura	DTAP~SANOFI PASTEUR~U13070B~5~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1381AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0233614	02/10/2005	MA	46.0	46		F	01/31/2005	Left arm swollen, red, sore, tender to touch, warm below injection site and extended to left elbow by 1/28/05. Admitted to hospital for 2 days. Treated with Keflex IV. On Keflex 500mg for four times a days by mouth for 7 days. Medical records states cellulitis. msv					Y	2			Y	01/25/2005	01/26/2005	1	NONE	PVT	PUB	Inderal; Folate	NONE	No known allergies; HBP; Spine Medical records states celiac disease, hypothyroid, anemia, anxiety. msv		MA0503	1						1	Cellulitis; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1555AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0233615	02/10/2005	NY	32.0	32		F	02/01/2005	Within 25 minutes experienced increased HR-see vital signs: 0930 HR 120 BP 140/80, 0932 88 118/70; 0935 72 110/70; 0940 68 112/68; 0945 64 110/62, 0950 68 110/60, 0955 60 108/60.									Y	02/01/2005	02/01/2005	0	NONE	OTH	PVT	UNK	NONE	NONE			1						1	Heart rate increased	FLU3~SANOFI PASTEUR~U1446AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233616	02/10/2005	TX	60.0	60		F	01/26/2005	Pt suffered swelling and redness of Right foot, swelling began PM of shot date, experienced pain in great toe, relieved, and washing on foot 01/26/05.									Y	01/24/2005	01/24/2005	0		OTH	PVT		NONE				1						1	Erythema; Oedema; Pain	FLU3~SANOFI PASTEUR~U1559BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233617	02/10/2005	MN	1.02	1	.0	M		Rash				Y					Y	12/13/2004	12/24/2004	11		PVT	UNK		NONE		Fever~DTaP (no brand name)~1~0.17~In Patient		1						1	Rash; Similar reaction on previous exposure to drug	DT~SANOFI PASTEUR~U1043BA~4~IM~RL~DT ADSORBED (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1473AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1051M~4~IM~RL~HIB (PEDVAXHIB)~1	USA	Emergency room visit	Influenza
0233618	02/10/2005	MS	51.0	51		M	02/03/2005	Area of injection is red, small inflammation. It was black and bleeding. It has no healed as of today's date 02/03/05. Is healing.									U	11/10/2004	11/11/2004	1		OTH	OTH		NONE	Allergic to morphine			1						1	Contusion; Injection site erythema; Injection site haemorrhage; Injection site inflammation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0233619	02/10/2005	PA	90.0	90		F	02/10/2005	Cough, congestion, chills, aches, fevers, Tamiflu 75mg 1 BID x 7 days.									U	10/19/2004	02/06/2005	110	2/8/05 Rapid Influenza Screen Positive	PVT	PVT	Reminyl, Celebrex, Lopressor, Xanax, Seroquel, Acipher, Benodyme, Xalang	NONE	DID, Osteoporosis, Alzheimer, Polythyroid, Tremor, Post Mastectomy			1						1	Chills; Cough; Myalgia; Nasal congestion; Pyrexia	FLU3~SANOFI PASTEUR~U1500AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233620	02/10/2005	MA	34.0	34		M	02/10/2005	Uncontrollable itching of the skin all over body for approximately 2 weeks.				Y					Y	01/28/2005	01/28/2005	0		MIL	MIL		NONE	NONE			1						1	Pruritus	FLUN3~MEDIMMUNE VACCINES, INC.~500354P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0233621	02/10/2005	MD	49.0	48		F	02/06/2005	Swollen Tongue and tight throat.				Y					Y	02/06/2005	02/06/2005	0		MIL	MIL			Lupus			1						1	Throat tightness; Tongue oedema	FLU3~SANOFI PASTEUR~U1515AA~UNK~ID~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0233622	02/10/2005	IL	1.07	1	.1	F	02/01/2005	Diffuse Urticaria				Y					U	01/28/2005	01/29/2005	1	NONE	PUB	PUB	NONE	Clear runny nose	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1464AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0322P~1~SC~LL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|PNC~PFIZER\WYETH~A74400~4~ID~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0274P~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0233623	02/10/2005	NY	70.0	69		M	02/07/2005	Felt lightheaded 24 hours.									Y	01/02/2005	01/21/2005	19		UNK	OTH		NONE				1						1	Dizziness	FLU3~SANOFI PASTEUR~U1528AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233624	02/10/2005	MO	25.0	25		F	02/06/2005	Redness 3-4cm in diameter.  Slight swelling and tender to touch.									Y	02/05/2005	02/05/2005	0		MIL	MIL	PPD	NONE	NONE			1						1	Erythema; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U1557AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233625	02/10/2005	MO	56.0	56		M	02/06/2005	3x3cm reddened area to injection site. Although this would not be concerning as isolated event, cell members who received dose from this vial had similar or worse reaction.									Y	02/05/2005	02/06/2005	1		MIL	MIL	Atenolol, multivitamins, allopurinol, Lipitor and PPD	NONE	HTN and high cholesterol			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U1954AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233626	02/10/2005	OK	68.0	67		F	01/06/2005	Fever, swelling, blurry eyes, throat closure, sores on tongue and swollen, hard to talk or speak or understand. Felt like eggs in shot were rancid.				Y					Y	10/18/2004	10/18/2004	0	Discussed with physician 12/1/04. Refused walk-in clinic & shot 10/20/04. Allergic to Benadryl. I have reason to believe this vaccine was rancid & out dated.	PVT	PVT	None at time of shot.	NONE	Diabetes			1						1	Pyrexia; Swelling; Throat tightness; Tongue oedema; Tongue ulceration; Vision blurred	FLU3~SANOFI PASTEUR~U1439AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0233666	02/10/2005	MT	0.54	0	.5	M	02/10/2005	Fever of 105 degrees axillary approximately 16 hours after administration.  Acetaminophen given with subsequent drop in temp. to 100.5 degrees.  No lethargy or limpness noted.  Child feeling fine with no temp after 24 hours.									Y	01/03/2005	01/04/2005	1		UNK	UNK	None	None	None			1						1	Pyrexia	DTAP~SANOFI PASTEUR~U1300AA~3~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1473AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1006~3~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~A74399~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0233667	02/10/2005	AK	26.0	26		M	02/10/2005	The patient developed a left nasolacrimal duct obstruction.  The patient had surgery for nasolacrimal duct obstruction, a dacryocystorhinostomy (DCR), in Feb 2004 for a left nasolacrimal duct obstruction.  He had a patent lacrimal system after his surgery.  The day he was administered the FluMist vaccine, he developed URI symptoms: stuffy nose and congestion.  The day after he got the vaccine, he developed epiphora, increased tearing, like he had prior to his DCR.  The patient tried blowing air into his punctum by holding his nose and blowing, but he could not get air into his left lower lid punctum.  He has had excessive tearing on the left side since then.									N	01/14/2005	01/15/2005	1		MIL	MIL					AK200540	1						1	Dacryostenosis acquired; Lacrimation increased; Nasal congestion; Upper respiratory tract infection	FLUN3~MEDIMMUNE VACCINES, INC.~500356P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0233671	02/10/2005	ID	20.0	19		F	02/10/2005	Patient reports nausea, dizziness and headaches 2 days.  Saw doctor - loss of duty for 24 hours.				Y					Y	02/08/2005	02/10/2005	2	NONE	MIL	MIL	NONE KNOWN	NONE KNOWN	NONE KNOWN			1						1	Dizziness; Headache; Nausea	FLUN3~MEDIMMUNE VACCINES, INC.~500356P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0233674	02/10/2005	CA	0.53	0	.5	M	02/08/2005	Fever 01/10/2005, ER 01/12/2005.  Sepsis requiring hospitalization for 2 days. Discharge summary states viral infection. msv Medical records state cough, diarrhea. msv				Y	Y	5			Y	01/07/2005	01/10/2005	3	01/12/2005 Blood Culture 01/12/2005 Chest X-Ray Medical records state abnomral lab results. msv	UNK	UNK		URI	NONE			1						1	Cough; Diarrhoea; Laboratory test abnormal; Pyrexia; Sepsis; Viral infection	DTAP~SANOFI PASTEUR~1699A~UNK~~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1467AA~UNK~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0145P~UNK~~LL~HIB + HEP B (COMVAX)~1|IPV~SANOFI PASTEUR~X11892~UNK~~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~495726~UNK~~RL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0233680	02/11/2005	TX	30.0	30		M	02/07/2005	Patient presented to clinic on 1/25/05 with rhinorrhea and congestion; was afebrile. Was given Extex. Was given FluMist vaccination on 1/28/05. Patient had worsening URI symptoms over weekend. Symptoms improved early the following week but worsened again by Friday, 2/4/05. Patient presented to clinic on 2/4; was diagnosed with rhonchi in right lung base. Was given Azythromycin and released. Patient became acutely ill later the same evening; had fever of 102. Taken to civilian ER and admitted to ICU step down unit. Treatment with Azythromycin, Rocephin, and IV fluids. Patient currently still admitted.Information from Discharge summary states dehydration, hypotension, cough, chills, tachycardic, nausea, vomiting. msv				Y	Y	3			Y	01/28/2005	02/04/2005	7	Nasal swab-dx with Influenza A From medical records, abnormal lab tests, ketones in urine.msv	MIL	MIL	Extex	URI	Celiac Sprue information received from medical records states allergy. msv			1						1	Chills; Condition aggravated; Cough; Dehydration; Hypotension; Influenza; Laboratory test abnormal; Malaise; Nasal congestion; Nausea; Pyrexia; Rhinorrhoea; Tachycardia; Upper respiratory tract infection; Urine analysis abnormal; Viral infection; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500357P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0233683	02/11/2005	TN	1.35	1	.4	F	12/14/2004	Febrile seizure; generalized tonic clonic 5 minute seizure. Maximum fever 101. Child hospitalized as observation/hold for 23 hours. No other problems or consequence.					Y	1			Y	12/09/2004	12/10/2004	1	NONE	PVT	PVT	Tylenol for fever	NONE	NONE			1						1	Febrile convulsion; Pyrexia	DTAP~GLAXOSMITHKLINE BIOLOGICALS~639A2~5~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~1463AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A57561A~5~IM~LL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0233684	02/11/2005	OR				F		Patient had flu shot at her obstetrician, patient is pregnant. That evening she complained of a severe headache, 10/10 on a scale of 1-10, a fever of 102 degrees. Came to the health clinic next day, complaining of occipital head that was 6/10 before Tylenol. She was advised to see doctor or go to the ER.				Y					U	02/02/2005	02/02/2005	0	Called CDC vaccine clinician information line, was informed severe headache was not an expected reaction.	PVT	OTH						1						1	Headache; Unintended pregnancy	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0233685	02/11/2005	TN	55.0	55		F	01/18/2005	Patient had a flu shot on 01/05/05. That night patient had a redish, blackish bruise about the size of her palm on her arm where the shot was given. Also had a headache. On 01/12/05, arm was only slightly bruised. Patient did not call her doctor.									Y	01/05/2005	01/05/2005	0	NONE	PUB	PUB		NONE	NONE		TN05003	1						1	Ecchymosis; Headache; Injection site reaction	FLU3~SANOFI PASTEUR~U1558AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233686	02/11/2005	TN	1.22	1	.2	F	01/06/2005	Vomiting and a fever of 104 degrees.				Y					U	01/05/2005	01/05/2005	0	None so far.	PUB	PVT	NONE	NONE	NONE		TN05001	1						1	Pyrexia; Vomiting	DTAP~SANOFI PASTEUR~U1006CA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1390AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0364P~3~IM~RL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0295N~1~SC~RA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|PNC~PFIZER\WYETH~A74398E~3~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0767P~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0233687	02/11/2005	WA	47.0	46		F	11/22/2004	Symptoms: Pain, swelling, hives, numbness, tingling, coldness to left arm from site up into shoulder and down to thumb. Thumb turned deep purple. Began 36-48 hours after shot and continued for additional 24 hours. Treatment: ice and Ibuprofen.									Y	11/16/2004	11/18/2004	2		PUB	OTH	NONE	N/A	Allergic to iodine, shellfish, sulpha and bees.		WA052091	1						1	Hypoaesthesia; Injection site pain; Injection site swelling; Paraesthesia; Peripheral coldness; Skin discolouration; Urticaria	FLU3~SANOFI PASTEUR~U1579AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233730	02/11/2005	CA	10.0	9		F	01/31/2005	10cm erythema over right arm where inj given.									Y	01/24/2005	01/25/2005	1	NONE	PVT	PVT	NONE	NONE	Asthma			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U1476AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0691P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0233741	02/11/2005	CA	62.0	62		F	02/11/2005	Went for flu for heel pain, otherwise healthy. Woke up next morning with 102 temp. Took ibuprofen, by that night, temp 103. Arm very painful. Talked to Dr's office and they said to take ibuprofen or go to ER if fever persists. Still has hot flashes, but feeling better.									Y	02/08/2005	02/09/2005	1	NONE	PUB	PUB	NONE	NONE	Stenosis, leg swelling, plantar (foot pain), Keratosis			1						1	Hot flush; Injection site pain; Pain in extremity; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~~~PNEUMO (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~2~~~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0233743	02/12/2005	AZ	97.0	97		F	02/12/2005	Patient was healthy for her age when vaccine was administered on 10/06/04.  On 10/11/04, patient was admitted to Hospital for respiratory distress.  Later diagnosis was pneumonia of an unknown itology.  Her main symptoms were a deep cough, extreme respiratory congestion, chills, high fever, etc.  Radiology confirmed presence of fluid on lungs.  Patient was given intraveneous antibiotics as well as Lasix to try and improve her condition. She did not respond to antibiotics and expired on 10/15/04.  No further information was given on Death Certificate or dischage summary, both rec'd on 03/02/2005.	Y	10/15/2004	Y	Y	Y				N	10/06/2004	10/11/2004	5	As prescribed by hospital.	UNK	UNK	eyedrops, baby aspirin	senile dementia	senile dementia, macular degeneraiton, arteriosclerosis			1						1	Chills; Cough; Lung disorder; Nasal congestion; Pneumonia; Pyrexia; Respiratory distress	FLU3~SANOFI PASTEUR~U1462AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0233767	02/14/2005	PA	58.0	58		M	02/09/2005	Steven's Johnson Syndrome.			Y	Y					Y	01/10/2005	01/12/2005	2	Blood work Information from medical records states abnormal lab tests, elevated blood glucose, elevated sed rate. msv	PVT	PVT	ASA; Lipitor	NONE	Nephritis; Kidney Stone			1						1	Hyperglycaemia; Laboratory test abnormal; Red blood cell sedimentation rate increased; Stevens-Johnson syndrome	FLU3~SANOFI PASTEUR~U1561AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0233769	02/14/2005	CA	56.0			M		Received a flu and pneumonia shot on left. Arm became red and swollen, also had emesis and high fever.				Y					Y				Diagnosed as cellulitis by PMD.	PUB	PUB		Hepatitis C				1						1	Cellulitis; Erythema; Oedema peripheral; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0233770	02/14/2005	OR	55.0	54		F	02/08/2005	36 hours after vaccine administered, patient reported 4 hours of explosive diarrhea, which then resolved.									Y	02/03/2005	02/05/2005	2		PVT	PVT	NONE	NONE	NONE			1						1	Diarrhoea	FLU3~SANOFI PASTEUR~U1532AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0889P~1~~RA~HEP A (VAQTA)~1|TD~AVENTIS PASTEUR~U1187AA~UNK~~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1|TYP~SANOFI PASTEUR~X08622~1~~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0233771	02/14/2005	CA	74.0	74		F	02/08/2005	Right arm and forearm swollen 3 times normal size. Arm is tight, warm and red, also experiencing severe pain, fever, headache, dizziness, marked weakness and muscle spasms. Symptoms were severe enough to require bed rest for 10 days and antihistamines for 3 weeks.									Y	01/06/2005	01/06/2005	0		PUB	PUB	Vitamins-Omega 3 and Advil	NONE	Hay fever			1						1	Asthenia; Dizziness; Erythema; Feeling hot; Headache; Muscle spasms; Oedema peripheral; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1556AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0887P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0233772	02/14/2005	MI	1.71	1	.7	F	01/11/2005	Urticaria rash with slight itching, involving face and body. Started about 24 hours after the administration. Atarax was used for relief.									Y	01/07/2005	01/08/2005	1	NONE	PVT	PUB	Tylenol and Motrin	NONE	Possible allergy to an antibiotic (unknown by mother)			1						1	Pruritus; Urticaria	DTAP~SANOFI PASTEUR~C1614AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1415AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0027P~3~IM~LL~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~495724~3~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0284P~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0233773	02/14/2005	FL	40.0	40		M	02/07/2005	Broke out in a rash on arms & front side of chest.				Y					U	02/02/2005	02/03/2005	1		OTH	MIL	NONE	NONE	NONE			1						1	Rash	FLU3~SANOFI PASTEUR~U1555AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0233774	02/14/2005	FL	67.0	67		F	02/07/2005	Client complained of having swollen painful muscle in area where vaccine was administered.				Y					Y	02/04/2005	02/05/2005	1		PUB	PUB	NONE	NONE	NKA			1						1	Injection site swelling; Myalgia	FLU3~SANOFI PASTEUR~U1568AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0371P~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0233775	02/14/2005	AK	2.0	2	.0	F	01/26/2005	Left thigh with 5x5 erythema patch with 1x1 central induration.  No adenopathy.				Y					Y	01/24/2005	01/25/2005	1	N/A	PVT	PUB		N/A	N/A		AK200519	1						1	Erythema	DTAP~GLAXOSMITHKLINE BIOLOGICALS~A59832~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1416AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A74405K~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0233776	02/14/2005	AK	1.28	1	.3	F	01/24/2005	This child has a red area to her right thigh that is warm to touch and slightly swollen.  Area is approximately 3x3.  Patient received immunization 01/21/2005.  Patient visited doctor on 01/23/2005 and 01/24/2005.  Still being followed up by care provider.				Y					U	01/21/2005	01/22/2005	1		PUB	OTH	NONE	Redness/swelling to right thigh	NONE		AK200517	1						1	Erythema; Feeling hot; Swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14A09AAA~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1416AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1040N~UNK~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0228924	02/15/2005	ME	71.0	70		F	02/11/2005	This case was initially considered non-serious. From follow up information received on 2/9/05 this case was considered serious. From initial information received on 11/1/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 70 year old female patient received a FLUZONE vaccination, lot number U1446AA, administered IM in the left deltoid on 10/28/04. Reportedly two days later on 10/30/04 at 10:00 AM, it was noted that the injection site was warm to the touch and red measuring about a quarter in diameter. On 10/31/04 the patient was sleepy, tired, had a poor appetite, a temperature of 100.8 degrees F and her blood pressure was 120/90. The injection site reaction was fading in color and size. On 11/1/04 the patient had a temperature of 99.8 degrees F and remains tired with a poor appetite. No treatment was administered. The patient's recovery status is listed as not recovered. From additional information received on 2/9/05 from a registered nurse, it was reported that the patient was vaccinated at a long term care facility. Per the reporter, on 11/3/04, the patient was more alert and ate 100% of her breakfast and lunch. On 11/5/04, the patient reportedly became very lethargic. She presented with torticollis to the left as well as a temperature of 99.5 degrees F, blood pressure 120/58, pulse 86, and respiratory rate of 16. The patient continued to decline rapidly between 11/5/04 and 11/8/04. She expired on 11/8/04 at 9:00 PM. The physician reported the cause of death as cerebrovascular accident/stroke. Other information provided included the patient's daily medications including Norvasc, Duragesic patch, Trilisate, potassium, Tums, Aldactone, Lasix, Librium, Risperdal, and Sorbitol. It was also reported that the patient previously received a dose of influenza vaccine on 11/11/03 without any reactions. Reportedly, no other flu injections were noted prior to that date. The reporter of this case is the same reporter of cases 200403591, 200403592, 200403593, 200403594, and 200403595.	Y	11/08/2004							N	10/28/2004	10/30/2004	2	NONE. From additional information received on 2/9/05, the following laboratory data was obtained: Glucose was elevated at 130; Chloride was elevated at 111; BUN was elevated at 42; Creatinine was elevated at 1.6; Sodium was elevated at 153; Calcium was elevated at 11.0; Carbon dioxide was within normal limits at 31.	OTH	PVT	Duragesic patch; Norvasc; Trilisate; Potassium Chloride; Tums; Aldactone; Lasix; Librium; Risperdal; Sorbitol		Reportedly the patient had no illnesses at the time of vaccination. The patient has a past medical history of hypertension, Alzheimer's and vascular insufficiency. The patient has allergies to penicillin, sulfa, iodine, shellfish, insect stings, and cephalosporins. From additional information received on 2/9/05, it was reported that the patient previously received a dose of influenza vaccine on 11/11/03 with no reactions. No other flu injections were noted prior to this date.		200403586	1						2	Anorexia; Blood calcium increased; Blood chloride increased; Blood creatinine increased; Blood glucose increased; Blood pressure decreased; Blood sodium increased; Blood urea increased; Cerebrovascular accident; Fatigue; Injection site erythema; Injection site warmth; Lethargy; Pyrexia; Somnolence; Torticollis	FLU3~SANOFI PASTEUR~U1446AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0233826	02/15/2005	MI	31.0	31		F	02/15/2005	Immediately after receiving the shot pain in upper arm then numbness (like hitting the funny bone) shooting pain down arm to fingertips.  Mentioned to the nurse on-site.  After one month, saw doctor prescribed Neurontin and Elavil for chronic pain.  Advised not to lift over 4 lbs. Follow-up with physician in 2 weeks.				Y					N	01/06/2005	01/06/2005	0	None	MIL	PVT	None	No	No			1						1	Hypoaesthesia; Pain	FLU3~SANOFI PASTEUR~U1569AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0233834	02/15/2005	MI	63.0	62		F	02/11/2005	From initial information received on 2/8/05 from a certified nurse practitioner regarding an adverse event occurring in the USA, it was reported that a 63 year old female patient received her second dose of FLUZONE, lot number U1488AA, administered IM in the left deltoid, and her second dose of PNEUMOVAX, lot number 656UN, administered IM in the left deltoid on 10/14/04 at 6:00 PM. The next day at 9:30 AM, the patient called her physician's office stating that her arm and fingers on her left side were swollen. She also complained of pain in the elbow to shoulder. She was advised to place ice on the area and to keep the arm elevated. She was also advised to take 600 milligrams of Motrin three times a day with food and to start Prednisone 10 milligrams in taper dose. On 10/21/04, the patient complained of pain in her left shoulder and she was seen the next day on 10/22/04. She did not have any swelling or redness and was diagnosed with tendonitis secondary to the vaccines. She was treated with 40 milligrams of Kenalog and 1 milliliter of Marcain injected in the joint and given Darvocet N-100. On 10/26/04, the patient stated that her left shoulder improved 98% and she had pain with abduction. On 11/8/04, the patient started physical therapy for tendonitis. On 12/17/04, she was treated with 40 milligrams of Kenalog injected in the joint and she was scheduled for an MRI. On 12/26/04, the patient was diagnosed with an anterior tear of the supraspinatus tendon for which she will have surgery. It was reported that the patient has not recovered from these events. (OMIC)				Y					N	10/14/2004	10/15/2004	1	MRI scheduled, 04Nov04 Sed rate elevated	PVT	PVT	Synthroid; Arimidex; Zocor;		The patient has a history of hypothyroidism, breast cancer in October 2003, and hyperlipidemia. She also has an allergy to Estraderm. She has had one previous dose of FLUZONE and PNEUMOVAX in October 2003 with no reactions reported.		200500342	1						1	Oedema peripheral; Pain; Red blood cell sedimentation rate increased; Shoulder pain; Tendon rupture; Tendonitis; Arthritis; Injection site swelling; Laboratory test abnormal; Oedema peripheral; Pain; Tendon rupture; Tendonitis	FLU3~SANOFI PASTEUR~U1488AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~656UN~2~IM~LA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~2~~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0233838	02/15/2005	CA	40.0	40		F	08/17/2005	This is a serious post marketed study case from a physician in the USA involving paroxysmal hemicrania. The reporter causality is possibly related to FluMist. A 48 year old female patient received FluMist on 11/3/04. On 11/6/04, the patient developed left side headache radiating to the left jaw. She was given Septra which was later changed to Augmentin. She was also given multiple pain medications, including Vicodin, Relafen, Nasal spray, Percocet and morphine, all of which did not relieve her. A CT scan of the head and sinuses done on 11/22/04 showed sinus mucosa disease and small air-fluid in right frontal sinus. The patient was hospitalized on 11/25/04. MRI and MRA of the brain done on 11/26/04 was essentially normal. Her chemistries, CBC and sedimentation rate were also normal. A neurologist was consulted and diagnosed her with paroxysmal hemicrania with overlapping symptoms of migraine. The patient was given Indocin, to which she responded. On 11/27/04, patient's condition was stable and improved and was discharged home to follow up as an outpatient. Previous medications being taken by the patient include Verapamil, Levothroid, Lovastatin, and Prilosec for gastric reflux. The patient has not yet recovered. The reporter determined the events to be possibly related to FluMist vaccination. 27 Jul 05, the patient recovered from all events except for hypoaesthesia. Complete information for this case submitted to VARES on 03 Aug 05 as a 15 Day expedited report in accordance with 21 CFR 600. 80- BT					Y	2			N	11/03/2004	11/06/2004	3	CT scan of head and sinuses - sinus mucosa disease and small air-fluid in right frontal sinus; MRI and MRA of the brain - essentially normal; BUN - 8; Creatinine - 0.7; Potassium - 3.7; ESR - 11; HGB - 13.4; WBC - 9.9.	OTH	OTH	Verapamil; Levothroid; Mevacor; Prilosec		Hypertension; Hypercholesterolemia; Hypothyroidism; Obesity; GERD; Possible depression; Tobacco use		MEDI0002818	1						1	Headache; Laboratory test abnormal; Migraine without aura; Sinusitis	FLUN3~MEDIMMUNE VACCINES, INC.~500337P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0233840	02/15/2005	WI	5.0	4		F	02/15/2005	Mother describes raised area 4 diameter (pancake size) tan/brown area at injection area, within 24 hours. Hot and bruised, no itching. Area lasted a week. As of 2/9/05 mother says area is fading. Will follow at clinic if not gone in 1 wk.									Y	01/20/2005	01/21/2005	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Contusion; Feeling hot; Injection site swelling; Skin discolouration	FLU3~SANOFI PASTEUR~U1425AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233841	02/15/2005	CA	1.25	1	.3	M	02/10/2005	Local reaction to shot with possible cellulitis warm to touch. TX: Keflex 200 3/4 tsp qd x 10d, Benadryl 1 tsp PO q 6 hr.									U	02/10/2005	02/10/2005	0		PVT	PUB		NONE	NONE			1						1	Cellulitis; Feeling hot	FLU3~SANOFI PASTEUR~U1414AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~U388AA~4~~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A83578C~4~~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0233843	02/15/2005	GA	8.0	7		M	02/07/2005	Toxic synovitis after receiving flu vaccine. Flu vaccine given 01/24/05, started complaining of leg pain on 01/25/05. Seen in doctors office 01/26/05 and 01/27/05. Treated with Ibuprofen.				Y					Y	01/24/2005	01/25/2005	1	X ray negative for fracture.	PUB	OTH	Ibuprofen	NONE	NONE			1						1	Drug toxicity; Pain; Synovitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0233845	02/15/2005	NC	58.0	57		F	02/02/2005	Patient complaining of numbness and tingling of extremities, muscle aches, lymphadenopathy. States neurologist diagnosed as neuro/CNS reaction. Also diagnosed decreased sensation in feet, legs and arms and tingling. Patient also seen at ED and released without hospitalization.				Y					Y	01/07/2005	01/07/2005	0	Nerve conduction studies negative. By patient history for GBS an MRI scheduled for 02/02/05.	PUB	PUB		None Known	None Known		NC05017	1						1	Guillain-Barre syndrome; Hypoaesthesia; Lymphadenopathy; Myalgia; Neurological symptom; Paraesthesia; Sensory disturbance	FLU3~SANOFI PASTEUR~U1479AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0233846	02/15/2005	VI	33.0			M	02/07/2005	After receiving the Flumist vaccine four days ago, within 24 hours I developed a brief sore throat, followed by severe cold symptoms-stuffed, runny nose-, which continue to this day. I am certain this is not a separate cold because I general only come down with 1-2 colds per year, usually 6 months apart. My most recent cold was only 1.5 months ago and fully recovered over 1 month ago. I have never come down with colds this close together before, and based on the confident this is the cause of my symptoms. The Flumist website and package insert detail some side effects similar to a cold, but make no mention of the potential severity or length of symptoms. Had I known I would be sacrificing my immediate health for the promise of protection from the flue, I would have never purchased the vaccine. I have seen numerous internet postings from others who have had similar reaction to the Flumist vaccine and strongly fell the safety/efficacy of the vaccine should be investigated. At the very least, the manufacture should be required to provided a more accurate description of the potential side effects of Flumist. I think it would give a consumer pause to know that they run the risk of developing what is identical to a severe cold from the Flumist vaccine.									U		02/03/2005			UNK	UNK						1						1	Pharyngitis; Pharyngolaryngeal pain; Rhinitis; Nasal congestion; Pharyngitis; Rhinitis; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500340P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0233871	02/16/2005	OH	14.0	14		F	02/16/2005	Left Arm has a knot and baseball size area with redness tender no drainage.									Y	02/11/2005	02/13/2005	2		PVT	PUB	Tylenol Sinus, Amoxil, Tamafed	Positive for Strep, URI	Medical Allergy to Codeine			1						1	Erythema; Injection site mass	FLU3~SANOFI PASTEUR~U1560AB~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233872	02/16/2005	VI	47.0	46		F	02/03/2005	After shots, client went to work, sat down, experienced sleepiness.  Went home - did not work, went home, slept for several hours and felt better.  Felt well next day - state had applied a therapeutic patch for back pain before shots and had not used one for 3 weeks.  Client states she thinks the patch was responsible for the episode.									Y	01/20/2005	01/20/2005	0	NONE	PUB	OTH	Therapeutic pain patches Premarin MSIR for back pain.	Back Pain	Back Pain Hepatitis C			1						1	Somnolence	FLU3~SANOFI PASTEUR~U1555AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0946N~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0233873	02/16/2005	VA		8		F	02/11/2005	Client appeared to faint and vomited.  Client put in semi-reclining position in exam room.  Vitals assessed.  Clint given soda to drink and recovered completely.									Y	02/11/2005	02/11/2005	0	Vital signs assessed. Temp 97.5, Pulse 96, BP 90/50	PUB	UNK		NONE	NONE		VA05002	1						1	Syncope; Vomiting	FLU3~SANOFI PASTEUR~U157AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233874	02/16/2005	MN	0.52	0	.5	F	02/10/2005	Whole body hives, pallor									Y	11/16/2004	11/16/2004	0		PVT	PVT						1						1	Pallor; Urticaria	DTAP~UNKNOWN MANUFACTURER~~UNK~~~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1	USA		Influenza
0233900	02/16/2005	VA	34.0	34		M	02/15/2005	10/17/04: Neck pain, bilateral ulnar paresthesias. 10/18/04: Left hand weakness, facial numbness, gait abnormalities. Rx: Medrol dose pack. 10/26/04: Gait abnormality worsening, truncal weakness. 10/27/04-10/29/04: Hospitalized for possible Guillain Barre; treated with IVIG. 1/3/05: Recurrence of symptoms. 1/19/05 LP. Dx: post vaccine hypersensitivity. Per follow up report received 05/21/2005, patient still has not recovered.  Total body patchy numbness and paresthesis.  Bilateral hand weakness with mild decreased rang of motion right hand.  Giat instability, easy fatiguability.  Released to work up to 50% - 4 hours a day since 03/24/2005. Per follow up report- Patient continues to suffer from 1) mild bilateral hand weakness 2) gait disturbance with Right quadriceps and Right anterior muscle weakness and lower abdominal weakness 3) diffuse generalized numbness and paresthesis 4) easy fatigued 5) prolonged recovery from simple illness-URI, strep. Since patient's return to work on 3/24/05, has only been able to return functionally at 55-60% of previous load.			Y	Y	Y	3			N	10/13/2004	10/17/2004	4	MRI; C spine; T spine; Brain NL; EMG/NCV NL 2 times; CSF negative protein; Negative oligoclononal bands; 24 hour heavy metal negative; Urine negative.	PVT	PVT	Probenecid; Advair; Albuterol	Recovered from hand, foot, mouth the week prior to vaccine	NKA; Gout; Asthma			1						1	Fatigue; Gait disturbance; Hypersensitivity; Hypoaesthesia; Muscular weakness; Neck pain; Paraesthesia	FLU3~SANOFI PASTEUR~U1409BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0233903	02/16/2005	UT	1.34	1	.3	M	02/16/2005	Hives WITH BRUISED CENTERS									Y	02/09/2005	02/11/2005	2		UNK	UNK	YELLOW TRIAMINIC	NONE	UNKNOWN-ADOPTED			1						1	Contusion; Urticaria	DTAP~SANOFI PASTEUR~C2000AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1443AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE561AA~4~IM~LL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0315P~1~IM~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A57562B~3~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0655P~1~IM~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0233907	02/16/2005	CT	71.0	71		M	01/18/2005	Pt developed rash on arms, face and scalp approx Oct 27. rash became more widespread areas subsequent weeks. Unresponsive to topical and systemic steroids. Skin biopsy revealed nonspecific changes with Eosinophil, suggesting a drug eruption.									N	10/22/2004			Skin Biopsy	PUB	UNK		NONE				1						1	Drug eruption; Rash	FLU3~SANOFI PASTEUR~U1517AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192676	02/17/2005		34.0	33		F	08/22/2003	A report received from a healthcare professional on 11/06/2002, concerning a 33 year old female vaccine who experienced headache, dizziness and hives within 1 hour of receiving Fluvirin. On 10/30/2002, the vaccinee experienced headache, dizziness and hives within 1 hour of receiving Fluvirin.  The vaccinee recovered on 10/31/2002.  This was the first time she received the Flu vaccine.   There was insufficient information to determine the reporter's causality assessment. Update 1. 12/23/2002. A follow up report received from a healthcare professional indicated that the vaccinee also experienced slight difficulty breathing within 1-2 hours of receiving Fluvirin.  The vaccinee recovered after 1-2 days. Cross reference with PJP-2002-707 and PJP-2002-00709.									U	10/30/2002	10/30/2002	0		UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200200708	1						2	Dizziness; Dyspnoea; Headache; Urticaria	FLU3~EVANS VACCINES~E37182KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0193226	02/17/2005		39.0	38		F	08/22/2003	A report was received from a healthcare professional on 08Nov02, concerning a female vaccinee of unk age who experienced an injection site reaction one day after receiving Fluvirin, while pregnant, on 28Oct02. The vaccinee had a similar reaction in 2000 to an influenza vaccine from manufacturer. The pt has no known drug allergies. On 29Oct02, the vaccinee developed a 5-7cm swollen, red area which was warm to the touch at the injection site (right deltoid muscle). The vaccine did not report any other symptoms. The redness received within two days without any intervention or treatment and the vaccinee had recovered from this event at the time of reporting. The reporter indicated that the vaccinee was pregnant but did not know which specific trimester. There was insufficient information to determine the reporters assessment of causality. Update 1: 21Jan03, the follow up report received from a healthcare professional indicated that the vaccinee receives Fluvirin yearly and that the vaccinee experienced the same event last year and resolved within approx one day. The date of last vaccination is reported as 12Dec00. The reporter clarified that the area of the injection site reaction was sore but the vaccinee had no problems using the extremity. There were no hives or rashes noted on any other part of the body. The vaccinee had not yet delivered her baby and at the time of the report. She was unaware of any problems with her pregnancy. The vaccinee had recovered from this event at the time of reporting. There was insufficient information to determine the reporter's assessment of causality.									U	10/28/2002	10/29/2002	1		UNK	UNK	Prenatal vitamins		Pregnant		PJP200200746	1						2	Feeling hot; Injection site erythema; Injection site oedema; Unintended pregnancy	FLU3~EVANS VACCINES~E33092HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0233908	02/17/2005		1.42	1	.4	M	08/22/2003	A report was received from a health care professional on 16Oct02, concerning a 17 month old male vaccinee who was inadvertently administered 0.25ml IM in the vastus lateralis on the 15Oct02. On 15Oct02, the vaccinee suffered a medication error by receiving 0.25ml Fluvirin into the vastus lateralis. The vaccinee had not experienced any adverse events at the time of the report but was being closely monitored. There was insufficient information to determine the reporter's causality assessment. PJP200200609, PJP200200671, PJP200200670, PJP200200669, PJP200200668, PJP200200667, PJP200200666, PJP200200665, PJP200200664, PJP200200663.									U	10/15/2002	10/15/2002	0		UNK	UNK	NONE		NONE		PJP200200662	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233909	02/17/2005		1.79	1	.8	M	08/22/2003	A report was received from a health care professional on 16Oct02, concerning a 22 month old male vaccinee who was inadvertently administered 0.25ml IM into the vastus lateralis on the 15Oct02. On 15Oct02, the vaccinee suffered a medication error by receiving 0.25ml Fluvirin into the vastus lateralis. The vaccinee had not experienced any adverse events at the time of the report but was being closely monitored. There was insufficient information to determine the reporter's causality assessment. PJP200200609, PJP200200671, PJP200200670, PJP200200669, PJP200200668, PJP200200667, PJP200200666, PJP200200665, PJP200200664, PJP200200662.									U	10/15/2002	10/15/2002	0		UNK	UNK	NONE		NONE		PJP200200663	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233910	02/17/2005		0.87	0	.9	F	08/22/2003	A report was received from a health care professional on 16Oct02, concerning a 22 month old male vaccinee who was inadvertently administered 0.25ml IM into the vastus lateralis on the 15Oct02. On 15Oct02, the vaccinee suffered a medication error by receiving 0.25ml Fluvirin into the vastus lateralis. The vaccinee had not experienced any adverse events at the time of the report but was being closely monitored. There was insufficient information to determine the reporter's causality assessment. PJP200200609, PJP200200671, PJP200200670, PJP200200669, PJP200200668, PJP200200667, PJP200200666, PJP200200665, PJP200200662, PJP200200663.									U	10/15/2002	10/15/2002	0		UNK	UNK	NONE		NONE		PJP200200664	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233911	02/17/2005		1.29	1	.3	M	08/22/2003	A report was received from a health care professional on 16Oct02, concerning a 22 month old male vaccinee who was inadvertently administered 0.25ml IM into the vastus lateralis on the 15Oct02. On 15Oct02, the vaccinee suffered a medication error by receiving 0.25ml Fluvirin into the vastus lateralis. The vaccinee had not experienced any adverse events at the time of the report but was being closely monitored. There was insufficient information to determine the reporter's causality assessment. PJP200200609, PJP200200671, PJP200200670, PJP200200669, PJP200200668, PJP200200667, PJP200200666, PJP200200664, PJP200200662, PJP200200663.									U	10/16/2002	10/16/2002	0		UNK	UNK	NONE		NONE		PJP200200665	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233912	02/17/2005		0.54	0	.5	M	08/22/2003	A report was received from a health care professional on 16Oct02, concerning a 6 month old male vaccinee who was inadvertently administered 0.25ml IM into the vastus lateralis on the 16Oct02. On 16Oct02, the infant suffered a medication error by receiving 0.25ml Fluvirin into the vastus lateralis. The infant had not experienced any adverse events at the time of the report but was being closely monitored. There was insufficient information to determine the reporter's causality assessment. PJP200200609, PJP200200671, PJP200200670, PJP200200669, PJP200200668, PJP200200667, PJP200200665, PJP200200664, PJP200200662, PJP200200663.									U	10/16/2002	10/16/2002	0		UNK	UNK	NONE		NONE		PJP200200666	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233913	02/17/2005		3.0	2	.7	M	08/22/2003	A report was received from a health care professional on 16Oct02, concerning a 6 month old male vaccinee who was inadvertently administered 0.25ml IM into the vastus lateralis on the 16Oct02. On 16Oct02, the infant suffered a medication error by receiving 0.25ml Fluvirin into the vastus lateralis. The infant had not experienced any adverse events at the time of the report but was being closely monitored. There was insufficient information to determine the reporter's causality assessment. PJP200200609, PJP200200671, PJP200200670, PJP200200669, PJP200200668, PJP200200666, PJP200200665, PJP200200664, PJP200200662, PJP200200663.									U	10/16/2002	10/16/2002	0		UNK	UNK	NONE		NONE		PJP200200667	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233914	02/17/2005		1.71	1	.7	M	08/22/2003	A report was received from a health care professional on 16Oct02, concerning a 6 month old male vaccinee who was inadvertently administered 0.25ml IM into the vastus lateralis on the 16Oct02. On 16Oct02, the infant suffered a medication error by receiving 0.25ml Fluvirin into the vastus lateralis. The infant had not experienced any adverse events at the time of the report but was being closely monitored. There was insufficient information to determine the reporter's causality assessment. PJP200200609, PJP200200671, PJP200200670, PJP200200669, PJP200200667, PJP200200666, PJP200200665, PJP200200664, PJP200200662, PJP200200663.									U	10/15/2002	10/15/2002	0		UNK	UNK	NONE		NONE		PJP200200668	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233915	02/17/2005		1.22	1	.2	F		A report was received from a health care professional on 16Oct02, concerning a 6 month old male vaccinee who was inadvertently administered 0.25ml IM into the vastus lateralis on the 16Oct02. On 16Oct02, the infant suffered a medication error by receiving 0.25ml Fluvirin into the vastus lateralis. The infant had not experienced any adverse events at the time of the report but was being closely monitored. There was insufficient information to determine the reporter's causality assessment. PJP200200609, PJP200200671, PJP200200670, PJP200200668, PJP200200667, PJP200200666, PJP200200665, PJP200200664, PJP200200662, PJP200200663.									U	10/14/2002	10/14/2002	0		UNK	UNK	NONE		NONE		PJP200200669	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233916	02/17/2005			0	.7	F	08/22/2003	A report was received from a health care professional on 16Oct02, concerning a 7 month old female vaccinee who was inadvertently administered 0.25ml Fluvirin IM into vastus lateralis on the 15Oct02. On 15Oct02, the infant suffered a medication error by receiving 0.25ml Fluvirin into vastus lateralis. The infant had not experienced any adverse events at the time of the report but was being closely monitored. There was insufficient information to determine the reporter's causality assessment.  PJP200200609, PJP200200671, PJP200200669, PJP200200668, PJP200200667, PJP200200666, PJP200200665, PJP200200664, PJP200200662, PJP200200663.									U	10/15/2002				UNK	UNK	NONE		NONE		PJP200200670	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233917	02/17/2005		3.0	3		M	08/22/2003	A report was received from a health care professional on 16Oct02, concerning a 3 year old male vaccinee who was inadvertently administered 0.5ml Fluvirin IM into vastus lateralis on the 14Oct02. On 14Oct02, the vaccinee suffered a medication error by receiving 0.5ml Fluvirin into the vastus lateralis. The infant had not experienced any adverse events at the time of the report but was being closely monitored. There was insufficient information to determine the reporter's causality assessment. PJP200200609, PJP200200670, PJP200200669, PJP200200668, PJP200200667, PJP200200666, PJP200200665, PJP200200664, PJP200200662, PJP200200663.									U	10/14/2002	10/14/2002	0		UNK	UNK	NONE		NONE		PJP200200671	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233918	02/17/2005		87.0			F	08/22/2003	A report was received from a health care professional on 11/01/02, concerning a female vaccinee older than 60 years who experienced chills 4 hours after receiving 0.5 ml Fluvirin intramuscularly, soreness and erythema at the injection site on the following day. On 10/25/02, the vaccinee experienced chills beginning approximately 4 hours following vaccination. The following morning the vaccinee experienced soreness and erythema (5'x3) around the injection site which lasted 5 days. The vaccinee had recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/18/02: A report was received indicating that the vaccinee was 87 years old. Vaccination occurred on 10/24/02. The vaccinee experienced a red rash and fever which began on 10/24/02 and lasted 2 weeks. The red rash and fever resolved. There was insufficient information to determine the reporter's causality assessment. Ref: PJP200200673 and PJP200200674.									Y	10/24/2002	10/24/2002	0		UNK	UNK	Concomitant Drug Not Used		No risk factors reported.		PJP200200672	1						1	Chills; Injection site erythema; Injection site pain; Pyrexia; Rash	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233919	02/17/2005		62.0			F	08/22/2003	A report was received from a health care professional on 11/1/02, concerning a male vaccinee older than 60 years who experienced soreness and erythema at the injection site one day after receiving 0.5ml of Fluvirin intramuscularly on 10/25/02. On 26/02, the vaccinee experienced soreness and erythema (5x4) at the injection site the morning after receiving Fluvirin on 10/25/02. the vaccinee has recovered at the time of the report. The vaccinee received Fluvirin last year without any adverse symptoms. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/18/02: A report was received indicating that the vaccinee was a 62 year old female. The vaccinee also experienced chills and fever which began on 10/19/02 and lasted 1 week. The chills and fever have resolved. There was insufficient information to determine the reporter's causality assessment. Cross reference with: PJP200200672 and PJP200200674.									Y	10/25/2002	10/26/2002	1		UNK	UNK	Concomitant Drug Not Used.		No risk factors reported.		PJP200200673	1						1	Injection site erythema; Injection site pain; Pyrexia	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233920	02/17/2005		71.0			M	08/22/2003	A report was received from a health care professional on 11/01/02, concerning a male vaccinee older than 60 years who experienced chills, soreness and erythema of the arm one day after receiving 0.5ml Fluvirin intramuscularly on 10/30/02. On 10/30/02, the vaccinee experienced chills approximately 4 hour post vaccination. The following morning, the vaccinee experienced soreness and erythema from the injection site to the elbow and encircling the arm. The vaccinee had not recovered at the time of reporting and is currently taking prophylactic antibiotics. the vaccinee received Fluvirin last year without any adverse symptoms. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/18/02: A 71 year old vaccinee experienced fever and a red area was hot to touch after receiving Fluvirin on 10/30/02. It was reported that symptoms lasted a week and then resolved.									N	10/30/2002	10/30/2002	0		UNK	UNK	Concomitant Drug Not Reported.		No risk factors reported.		PJP200200674	1						1	Chills; Injection site erythema; Injection site pain; Injection site warmth; Pyrexia	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233921	02/17/2005		56.0	55		F	08/22/2003	A report received from a consumer on 11/04/02, concerning a 55 year old female vaccinee who experienced pain, redness, swelling and warmth at the injection site a few hours after receiving the Fluvirin vaccine in the upper arm on 10/29/02. On 10/29/02, the vaccinee experienced severe pain, redness, swelling and warmth at the injection site which worsened for a few days. On 11/1/02, the vaccinee was seen by a dermatologist for a routine examination and was advised to place ice packs on the affected area. The vaccinee did not take any medication to relieve the symptoms. At the time of this report the symptoms are alleviated and tolerable but not completely resolved. The vaccinee has previously received influenza injections (brand unspecified) for many years without any problems.				Y					N	10/29/2002	10/29/2002	0		UNK	UNK	Flonase (Preparation for external use (NOS)) months-ongoing		No risk factors reported.		PJP2000200675	1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0233922	02/17/2005					F	08/22/2003	A report was received from a health care professional on 11/04/02, concerning a female vaccinee in her 30's who experienced a tingling sensation on her lips and cheeks 30-45 minutes after receiving Fluvirin intramuscularly on 11/04/02. The symptoms had not resolved at the time of the report. It was reported that the vaccinee had not been exposed to influenza vaccine before nor had any allergy to eggs. The reporter has assessed the relationship of the vaccine to the event as probable.									U	11/04/2002	11/04/2002	0		UNK	UNK	Concomitant Drug Not Used.		No risk factors reported.		PJP200200676	1						1	Paraesthesia; Paraesthesia oral	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233923	02/17/2005		46.0			F	08/22/2003	A report was received from a health care professional on 21Oct02, concerning a female vaccinee who was inadvertently administered last years batch of Fluvirin on 18Oct02. On 18Oct02, the vaccinee received 0.5ml Fluvirin IM. It was discovered later that it was last years batch. No adverse effects were reported at time of reporting. There was insufficient information to determine the reporter's causality assessment.  Ref: PJP200200677. Update 1 12Feb03: A report was received from a health care professional concerning a 46 year old vaccinee. The vaccinee was revaccinated with the 2003 vaccine (brand unspecified) on an unspecified date. The vaccinee experienced no adverse event at the time of the report.									U	10/18/2002	10/18/2002	0		UNK	UNK	NONE		NONE		PJP200200678	1						1	Medication error	FLU3~EVANS VACCINES~E05221KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0233924	02/17/2005		50.0			F	08/22/2003	A report was received from a health care professional on 01Nov02 concerning a 50 year old female vaccinee who was inadvertently administered Fluvirin SC and experienced local redness and warmth at the injection site one day after receiving Fluvirin on 24Oct02. On 24Oct02 the vaccinee was inadvertently admin 0.5ml Fluvirin SC. On 25Oct02 the vaccinee experienced local redness and warmth at the injection site. The vaccinee had recovered at the time of the report. The reporter has assessed the relationship of the vaccinee to the event as probable.									U	10/24/2002	10/25/2002	1		UNK	UNK	Insulin		NONE		PJP200200679	1						1	Feeling hot; Injection site erythema; Medication error	FLU3~EVANS VACCINES~E35792KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233925	02/17/2005		59.0			M	08/22/2003	A report received from a health care professional on 01Nov02, concerning a 59 year old male vaccinee who experienced soreness, redness at the injection site and arthralgia 1 day after receiving Fluvirin on 30Oct02. On 31Oct02, the vaccinee experienced soreness, redness and arthralgia at the injection site after receiving Fluvirin. The vaccinee also received a pneumonia vaccine on 30Oct02 on the opposite arm, and also experienced soreness, redness, and arthralgia of a greater degree of severity at that injection site on 31Oct02. The vaccinee was prescribed diphenhydramine hydrochloride 25mg orally every 6 hours (with 50mg at bedtime for 3 days). If the reaction continues the physician will be prescribing Levofloxacin. At the time of reporting the vaccinee has not yet recovered. The reporter has assessed the relationship of the vaccine to the event probable and indicated that the event was a local allergic reaction to the vaccination.									U	10/30/2002	10/31/2002	1		UNK	UNK	Lipitor 20mg (daily), Zoloft 50mg (daily)		The pt has a medical history of penicillin allergy.		PJP200200680	1						1	Arthralgia; Injection site erythema; Injection site pain	FLU3~EVANS VACCINES~E35742KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233926	02/17/2005		24.0	23		F	08/22/2003	A report received from a health professional on 01Nov02 concerning a 23 year old female vaccinee who experienced soreness and erythema at the injection site on the same day she received Fluvirin on 30Oct02. On 30Oct02, the pt experienced soreness and erythema, 1.5 inches in diameter, at the injection site. The pt has had no prior influenza vaccination and has no history of egg allergy. At the time of reporting the pt had not yet recovered. The reporter has assessed the relationship of the vaccine to the event as probable.									U	10/30/2002	10/30/2002	0		UNK	UNK	NONE		NONE		PJP200200681	1						1	Injection site erythema; Injection site pain	FLU3~EVANS VACCINES~E35502KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233927	02/17/2005		55.0			F	08/22/2003	A report received from a healthcare professional on 05Nov02 concerning a 55 year old female vaccinee who experienced an injection site reaction two days after receiving Fluvirin on 29Oct02. On 31Oct02 the vaccinee complained of redness and tenderness of an 19x 10cm area at the injection site. The pt received methylprednisolone to treat the symptoms of the event. The outcome of this event is unk. There was insufficient information to determine the reporter's causality assessment.  See Ref: PJP200200683, PJP200200684, PJP200200685, PJP200200686.									U	10/29/2002	10/31/2002	2		UNK	UNK	NONE		NONE		PJP200200682	1						1	Injection site erythema; Injection site reaction; Tenderness	FLU3~EVANS VACCINES~E35712KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233928	02/17/2005					M	08/22/2003	A report received from a healthcare professional on 05Nov02 concerning a male vaccinee in his forties who experienced headache and redness, itching and burning immediately after receiving Fluvirin on 01Nov02.  On 01Nov02 the vaccinee complained of headache and of redness, itching and burning that extended from the upper arm to the elbow. No medical intervention was required as the symptoms were self-limiting. The symptoms resolved within 1 day and the pt has recovered from the event. There was insufficient information to determine the reporter's causality assessment. See Ref: PJP200200682, PJP200200684, PJP200200685, PJP200200686.									U	11/01/2002	11/01/2002	0		UNK	UNK	NONE		NONE		PJP200200683	1						1	Headache; Injection site erythema; Pruritus; Skin burning sensation	FLU3~EVANS VACCINES~E35712KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233929	02/17/2005					F	08/22/2003	A report received from a health professional on 05Nov02 concerning a female vaccinee in her fifties who experienced an injection site reaction the morning after receiving Fluvirin on 01Nov02. On the morning of 02Nov02 the vaccinee complained of redness, itching and burning at the injection site. No medical intervention was required as the symptoms were self limiting. The symptoms resolved within a day and the pt is currently recovered. There was insufficient information to determine the reporters causality assessment. See Ref: PJP200200682, PJP200200683, PJP200200685, PJP200200686									U	11/01/2002	11/02/2002	1		UNK	UNK	NONE		NONE		PJP200200684	1						1	Injection site erythema; Pruritus; Skin burning sensation	FLU3~EVANS VACCINES~E35712KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233930	02/17/2005					F	08/22/2003	A report received from a healthcare professional on 05Nov02, concerning a female vaccinee in her fifties who experienced an injection site reaction the morning after receiving Fluvirin on 01Nov02. On the morning of 02Nov02 the vaccinee complained of redness, itching, and burning at the injection site. No medical intervention was required since the symptoms were self limiting. The symptoms resolved within one day and the pt has recovered. There was insufficient information to determine the reporter's causality assessment. See Ref: PJP200200682, PJP200200683, PJP200200684, PJP200200686.									U	11/01/2002	11/02/2002	1		UNK	UNK	NONE		NONE		PJP200200685	1						1	Injection site erythema; Pruritus; Skin burning sensation	FLU3~EVANS VACCINES~E35712KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233931	02/17/2005					U	08/22/2003	A report received from a healthcare professional on 05Nov02, concerning a vaccinee (age and gender unk) who experienced an injection site reaction the morning after receiving Fluvirin on 01Nov02. On the morning of 02Nov02 the vaccinee complained of redness, itching, and burning at the injection site. No medical intervention was required since the symptoms were self limiting. The symptoms resolved within one day and the pt has recovered. There was insufficient information to determine the reporter's causality assessment. See Ref: PJP200200682, PJP200200683, PJP200200684, PJP200200685.									U	11/01/2002	11/02/2002	1		UNK	UNK	NONE		NONE		PJP200200686	1						1	Injection site erythema; Pruritus; Skin burning sensation	FLU3~EVANS VACCINES~E35712KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233932	02/17/2005					U	08/22/2003	A report was received from a health care professional on 04Nov02 concerning a group of three vaccinees who experienced chills 5 days after receiving Fluvirin on 29Oct02. On 03Nov02 the vaccinees experienced chills 5 days after receiving 0.5ml Fluvirin IM. Vaccinees were residents of a long term care facility. The attending nurse felt that the chills should be investigated as possibly related to the vaccine although the attending physician was doubtful about this.									U	10/29/2002	11/03/2002	5		UNK	UNK	NONE		NONE		PJP200200687	1						1	Chills	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233933	02/17/2005					U	08/22/2003	A report received from a health professional on 04Nov02, concerning a vaccinee of unk demography who was administered expired influenza vaccine (brand unspecified) on 04Nov02. On 04Nov02, the vaccinee was inadvertently administered expired influenza vaccine (brand unspecified). No adverse event was reported. The vaccinee will be closely monitored for adverse events. There was insufficient information to determine the reporter's causality assessment.									U	11/04/2002	11/04/2002	0		UNK	UNK	NONE		NONE		PJP200200688	1						1	Medication error	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0233934	02/17/2005					F	08/22/2003	A report received from a health professional on 08Nov02, concerning a female vaccinee  who inadvertently received Fluvirin SC on 07Nov02. On 07Nov02 the vaccinee received 0.5ml Fluvirin SC.  No adverse event was reported in relation to the incident. There was insufficient information to determine the reporter's causality assessment.  Cross reference with: PJP200200731, PJP200200729, PJP200200743, PJP200200728, PJP200200742, PJP200200741, PJP200200720, PJP200200745.									U	11/07/2002	11/07/2002	0		UNK	UNK	NONE		NONE		PJP200200690	1						1	Medication error	FLU3~EVANS VACCINES~E32072GA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233935	02/17/2005					F	08/22/2003	A report was received from a health care professional concerning a female vaccinee in her 40s who experienced a shortness of breath hours after receiving 0.5ml Fluvirin on 28Oct02. On 28Oct02 the vaccinee experienced shortness of breath more than 20 minutes after vaccination with 0.5ml Fluvirin IM. The vaccinee was seen in an urgent care clinic and then transferred to the ER of an unspecified hospital. Details of the ER visit were not reported. On 29Oct the vaccinee was reported to be fine and her condition resolved without sequelae. The reporter has assessed the relationship of the vaccine to the event as unclassifiable.							Y		U	10/28/2002	10/28/2002	0		UNK	UNK	NONE		NONE		PJP200200695	1						1	Dyspnoea	FLU3~EVANS VACCINES~E31882GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0233936	02/17/2005		2.0	1	1	M	08/22/2003	A report was received from a health professional on 17Oct02, concerning a 2 year old male vaccinee who was inadvertently administered 0.5ml Fluvirin on 15Oct02. On 15Oct02, the vaccinee experienced an overdose after inadvertently receiving 0.5ml Fluvirin. No adverse effects were reported at time of report. No other information was available. There was insufficient information to determine the reporter's causality assessment.									U	10/15/2002	10/15/2002	0		UNK	UNK	NONE		NONE		PJP200200697	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233937	02/17/2005		72.0			M	08/22/2003	A report was received from a health care professional on 31Oct02 concerning a male vaccinee of unk demography who received 0.5ml Fluvirin SC on 31October02. There was insufficient information to determine the reporter's causality assessment. Update 1, 03Dec02: A report was from a health care professional indicating that the vaccinee was 72 years old. No adverse reaction was reported.									U	10/31/2002				UNK	UNK	NONE		NONE		PJP200200698	1						1	Unevaluable event	FLU3~EVANS VACCINES~~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233938	02/17/2005		79.0	78		M	08/22/2003	A report was received from a health care professional concerning a 78 year old male vaccinee who was inadvertently administered last years batch of Fluvirin on 23Oct02. On 23Oct02 the vaccinee was administered 0.5ml Fluvirin IM which was found to be last years batch of Fluvirin with expiration date 30Jun02. No adverse reaction was reported in relation to the vaccination. The reporter has assessed the relationship of the vaccine to the event as unclassifiable.									U	10/23/2002	10/23/2002	0		UNK	UNK	NONE		NONE		PJP200200703	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233939	02/17/2005					U	08/22/2003	A report received from a health care professional on 04Nov02 concerning an unk number of vaccinees who inadvertently received frozen Fluvirin on an unk date. On an unk date, an unk number of vaccinees were inadvertently administered frozen Fluvirin. The reporter was not aware of any adverse reactions experienced by the vaccinees. There was insufficient information to determine the reporter's causality assessment.									U					UNK	UNK	NONE		NONE		PJP200200704	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233940	02/17/2005					F	08/22/2003	A report received from a health care professional on 06Nov02 concerning a female vaccinee of less than 4 years old who was inadvertently administered 0.25ml Fluvirin on 25Oct02. On 25Oct02 the vaccinee who was less than 4 years old was administered 0.25 ml Fluvirin IM. No adverse event was reported in relation to the incident.  There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200200706.									U	10/25/2002	10/25/2002	0		UNK	UNK	NONE		NONE		PJP200200705	1						1	Medication error	FLU3~EVANS VACCINES~E31202GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233941	02/17/2005					M	08/22/2003	A report received from a health care professional on 06Nov02 concerning a male vaccinee of less than 4 years old who was inadvertently administered 0.25ml Fluvirin on 25Oct02. On 25Oct02 the vaccinee who was less than 4 years old was administered 0.25 ml Fluvirin IM. No adverse event was reported in relation to the incident.  There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200200705.									U	10/25/2002	10/25/2002	0		UNK	UNK	NONE		NONE		PJP200200706	1						1	Medication error	FLU3~EVANS VACCINES~E31202GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233942	02/17/2005					U	08/22/2003	A report received from a health care professional on 06Nov02 concerning 2 adult vaccinees of unk demography who experienced headache and dizziness within 1 hour of receiving Fluvirin on 30Oct02. On 30Oct02 4 vaccinees experienced headache and dizziness within 1 hour of receiving Fluvirin. The vaccinees recovered the same day.  There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200200708 and PJP200200709.									U	10/30/2002	10/30/2002	0		UNK	UNK	NONE		NONE		PJP200200707	1						1	Dizziness; Headache	FLU3~EVANS VACCINES~E37182KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233944	02/17/2005		61.0			F	08/22/2003	A report received from a health professional on 11/06/2002, concerning a 61 year old female vaccinee who experienced headache and diziness within 1 hour of receiving Fluvirin, and chest pain 3 days after receiving Fluvirin on 10/30/2002. On 10/30/2002, the vaccinee experienced headache and dizziness within 1 hour of receiving Fluvirin.  On 11/02/2002, the vaccinee experienced chest pain and was admitted to the emergency room for observation for 12 hours.  The ER physician indicated that the chest pain was associated with arthritic symptoms secondary to Fluvirin.  The vaccinee was treated with an anti-inflammatory agent and discharged home.  The symptoms resolved. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP-2002-7007 and PJP-2002-00708.									U	10/30/2002	10/30/2002	0		UNK	UNK	paxil, Premarin, Atenolol		No risk factors reported.		PJP200200709	1						1	Arthritis; Chest pain; Dizziness; Headache	FLU3~EVANS VACCINES~E37182KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233945	02/17/2005					F	08/22/2003	A report was received from a health care professional on 11/05/2002, concerning a female vaccinee in her 40s who experienced joint pain 1 week after receiving virus influenza on an unreported date in 2001. On an unreported date in 2001 the vaccinee experienced joint pain 1 week after receiving virus influenza. No treatment was administered and the joint pain resolved after a few days. The reporter has assessed the relationship of the vaccine to the event as unclassifiable.									Y					UNK	UNK					PJP200200710	1						1	Arthralgia	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0233946	02/17/2005		3.17			M	08/22/2003	A report received from a health professional on 11/05/2002, concerning a 38 month old vaccinee who was inadvertently administered Fluvirin. On 10/29/2002, the vaccinee was inadvertently administered Fluvirin. No adverse event occurred. There was insufficient information to determine the reporter's causality assessment									U	10/29/2002	10/29/2002	0		UNK	UNK					PJP200200711	1						1	Medication error	FLU3~EVANS VACCINES~~2~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233947	02/17/2005		69.0			F	08/22/2003	A report was received from a consumer on 11/04/2002, concerning a 69 year old female vaccinee who experienced hives and loss of energy (two days post-vaccination) and night sweats ( 7 days post-vaccination ) after receiving Fluvirin on 10/15/2002. On 10/17/2002 the vaccinee developed eight to ten hives on her legs and buttocks and complained of having no energy. Approximately a week after receiving the vaccine the vaccinee began to experience night sweats. The vaccinee's glucose sugar level was within normal limits when she experienced the night sweats. At the time of this report the patient was still experiencing night sweats. The hives and loss of energy were reported as resolved on an unknown date.									N	10/15/2002	10/17/2002	2		UNK	UNK	Insulin , Premarin , Synthroid				PJP200200712	1						1	Asthenia; Night sweats; Urticaria	FLU3~EVANS VACCINES~E30412GA~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233948	02/17/2005					F	08/22/2003	A report received from a health professional on 11/05/2002, concerning a female vaccinee of unknown age who received 2 administrations of Fluvirin. The vaccinee was administered 2 doses on 10/23/2002 and 11/04/2002. Both doses were administered intramuscularly in the deltoid region of the arm. No adverse events were observed. The reporter has assessed the relationship of the vaccine to the event as unclassifiable.									Y	10/23/2002	11/04/2002	12		UNK	UNK					PJP200200713	1						1	Accidental overdose; Medication error	FLU3~EVANS VACCINES~~3~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233949	02/17/2005		59.0			M	08/22/2003	A report received from a health professional on 11/06/2002, concerning a 59 year old male vacinee who developed hives 3 days after receiving Fluvirin on 10/29/2002. On 11/01/2002 the vaccinee developed hives 3 days after receiving Fluvirin, the vaccinee did not have any other symptoms of an allergic reaction. The vaccinee treated himself with Benadryl. On 11/03/2002 the vaccinee recovered. There was insufficient information to determine the reporter's causality assessment.									Y	10/29/2002	11/01/2002	3		UNK	UNK			Previous reaction to bee sting , Penicillin allergy		PJP200200714	1						1	Urticaria	FLU3~EVANS VACCINES~E35452HA~3~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233950	02/17/2005		2.0			M	08/22/2003	A report received from a health care professional on 11/06/02, concerning a 2 year old male vaccinee who was administered Fluvirin. On 11/04/02, the vaccinee was administered 0.25 ml of Fluvirin vaccine. No adverse symptoms were reported. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/31/02: An update report was received from a health care professional which indicated that the vaccinee did not experienced any adverse effects at the time of the report.									U	11/04/2002				UNK	UNK	Concomitant Drug Not Reported.		No risk factors reported.		PJP200200715	1						1	Medication error	FLU3~EVANS VACCINES~E10132FA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233951	02/17/2005		36.0	36		F	08/22/2003	A report was received from a consumer on 11/05/02, concerning a 16 year old female who experienced right side facial paralysis, headache and fatigue after receiving Fluvirin on 10/24/02. On 10/24/02 the patient received a Fluvirin vaccine and experienced headache and fatigue on 10/25/02. On 10/28/02, the patient experienced facial paralysis. The patient could not mover any of her facial muscles from the top of her forehead to the collar bone on the right side of her face. The patient has been given methylprednisone for 6 days and valacyclovir 500 mg Q12H for 10 days for treatment of the adverse event. The headache and the fatigue recovered on 10/26 and 10/27 respectively, but the patient is still exhibiting symptoms of the paralysis. The patient was scheduled for a MRI for further evaluation. The reporter has assessed the relationship of study medication to the facial paralysis as possible. On 11/06/2, the patient contacted the manufacture again and requested compensation for the medical expenses incurred as a result of the adverse event. A follow up report was received from a health care professional on 12/02/02. The reporter diagnosed the vaccinee with partial facial paralysis. The vaccinee was described as healthy and event was improving. Results of the MRI examination was negative. There was insufficient information to determine the reporter's causality assessment.									U	10/24/2002	10/25/2002	1		UNK	UNK	Claritin D		No risk factors reported. Allergy (unspecified)		PJP200200716	1						1	Facial palsy; Fatigue; Headache	FLU3~EVANS VACCINES~E33162GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233952	02/17/2005					U	08/22/2003	A report received from a health care professional on 11/06/02, concerning approximately 100 vaccinees less than 4 years of age who were inadvertently administered Fluvirin on unknown dates. The reporter is in the process of indentifying the vaccinees. It is not known if any of the vaccinee's subsequently experienced adverse events. There was insufficient information to determine the reporter's causality assessment.									U					UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200200717	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233953	02/17/2005		2.0			F	08/22/2003	A report was received from a health care professional on 11/07/02, concerning a 2 year old female vaccinee who inadvertently received 0.5ml of Fluvirin on 11/06/02. There was insufficient information to determine the reporter's causality assesment.									U	11/06/2002				UNK	UNK	Claritin		No risk factors reported.		PJP200200718	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233954	02/17/2005		81.0	81		F	08/22/2003	A report was received from a health care professional on 11/08/02, concerning an 81 year old female vaccinee who experienced blurred vision and double vision immediately after receiving Fluvirin on 10/30/02. At the time of reporting the vaccinee had not yet recovered. There was insufficient information to determine the reporter's causality assessment.									U	10/30/2002	10/30/2002	0		UNK	UNK	Albuterol, Atrovent, Warfarin Sodium, Humibid, Temazepam, Glyceryl Trinitrate, Oxygen		Congestive Heart Failure, Hypertension, Angina, Migraines, COPD, Dementia, Pace Maker, Tendonitis, Stroke and Ascites.		PJP200200723	1						1	Diplopia; Vision blurred	FLU3~EVANS VACCINES~E30142GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233955	02/17/2005		83.0	83		M	08/22/2003	A report received from a healthcare professional on 11/08/02, concerning a 83 year old male vaccinee who experienced double vision one week after receiving Fluvirin on 10/30/2002. The vaccinee had not yet recovered at the time of reporting. There was insufficient information to determine the reporter's assessment of causality.									N	10/30/2002	11/06/2002	7		UNK	UNK	Lorazepam, Temazepam, Vitamin B12		No risk factors reported.		PJP200200724	1						1	Diplopia	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233956	02/17/2005		85.0			M	08/22/2003	A report received from a health care professional on 11/11/02, concerning an 85 year old male vaccinee who inadvertently received expired Fluvirin vaccine on an unknown date. No adverse events were experienced by the vaccinee. There was insufficient information to determine the reporter's causality assessment. See ref: PJP200200727									U					UNK	UNK	Concomitant Drug Not Reported.		No risk factors reported.		PJP200200726	1						1	Medication error	FLU3~EVANS VACCINES~E02761HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233957	02/17/2005		80.0			F	08/22/2003	A report received from a health care professional on 11/11/02, concerning an 80 year old female vaccinee who inadvertently received expired Fluvirin vaccine on an unknown date. The vaccinee did not experience any adverse events. There was insufficient information to determine the reporter's causality assessment. See Ref: PJP200200726.									U					UNK	UNK	Concomitant Drug Not Reported.		No risk factors reported.		PJP200200727	1						1	Medication error	FLU3~EVANS VACCINES~E02761HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233958	02/17/2005					F	08/22/2003	A report was received from a health care professional on 11/08/02, concerning a female vaccinee who inadvertently received Fluvirin Subcutaneously on 11/07/02. No adverse reaction was reported in relation to the incident. There was insufficient information to determine the reporter's causality assessment. Cross reference with: PJP200200731, PJP200200741 and PJP200200749.									U	11/07/2002				UNK	UNK	Concomitant Drug Not Reported.		No risk factors reported.		PJP200200728	1						1	Medication error	FLU3~EVANS VACCINES~E32072GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233959	02/17/2005					M	08/22/2003	A report was received from a health care professional on 11/08/2002, concerning a male vaccinee who inadvertently received Fluvirin subcutaneously on 11/07/02. No adverse reaction was reported in relation to the incident. There was insufficient information to determine the reporter's causality assessment. Cross reference with: PJP200200731, PJP2002000743 and PJP200200728.									U	11/07/2002				UNK	UNK	Concomitant Drug Not Used.		No risk factors reported.		PJP200200729	1						1	Medication error	FLU3~EVANS VACCINES~E32072GA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233960	02/17/2005					U	08/22/2003	A report was received from a health care professional on 08Nov02, concerning a male vaccinee who inadvertently received Fluvirin SC on 07Nov02. On 07Nov02 the vaccinee received 0.5ml Fluvirin SC. No adverse reaction was reported in relation to the incident. There was insufficient information to determine the reporter's causality assessment. Cross reference with: PJP-2002-00728, PJP200200690, PJP200200729, PJP200200793, PJP200200792, PJP200200791, PJP200200720, PJP200200745, PJP200200743.									U	11/07/2002	11/07/2002	0		UNK	UNK	NONE		NONE		PJP200200731	1						1	Medication error	FLU3~EVANS VACCINES~E320720A~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233961	02/17/2005					U	08/22/2003	A report was received from a health care professional on 08Nov02, concerning a female vaccinee who inadvertently received Fluvirin SC on 07Nov02. On 07Nov02 the vaccinee received 0.5ml Fluvirin SC. No adverse reaction was reported in relation to the incident. There was insufficient information to determine the reporter's causality assessment. Cross reference with: PJP-2002-00731, PJP200200729, PJP200200749, PJP200200744, PJP200200742, PJP200200720, PJP200200745, PJP200200690, PJP200200743.									U	11/07/2002	11/07/2002	0		UNK	UNK	NONE		NONE		PJP200200741	1						1	Medication error	FLU3~EVANS VACCINES~E32072GA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233963	02/17/2005					F	08/22/2003	A report was received from a health care professional on 08Nov02, concerning a female vaccinee who inadvertently received Fluvirin SC on 07Nov02. On 07Nov02 the vaccinee received 0.5ml Fluvirin SC. No adverse reaction was reported in relation to the incident. There was insufficient information to determine the reporter's causality assessment. Cross reference with: PJP-2002-00731, PJP200200729, PJP200200749, PJP200200744, PJP200200741, PJP200200720, PJP200200745, PJP200200690, PJP200200743.									U	11/07/2002	11/07/2002	0		UNK	UNK	NONE		NONE		PJP200200742	1						1	Medication error	FLU3~EVANS VACCINES~E3207GA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233964	02/17/2005					F	08/22/2003	A report was received from a health care professional on 08Nov02, concerning a female vaccinee who inadvertently received Fluvirin SC on 07Nov02. On 07Nov02 the vaccinee received 0.5ml Fluvirin SC. No adverse reaction was reported in relation to the incident. There was insufficient information to determine the reporter's causality assessment. Cross reference with: PJP-2002-00731, PJP200200729, PJP200200799, PJP200200792, PJP200200791, PJP200200720, PJP200200745, PJP200200690.									U	11/07/2002	11/07/2002	0		UNK	UNK	NONE		NONE		PJP200200743	1						1	Medication error	FLU3~EVANS VACCINES~E32072GA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233965	02/17/2005					F	08/22/2003	A report was received from a health care professional on 08Nov02, concerning a female vaccinee who inadvertently received Fluvirin SC on 07Nov02. On 07Nov02 the vaccinee received 0.5ml Fluvirin SC. No adverse reaction was reported in relation to the incident. There was insufficient information to determine the reporter's causality assessment. Cross reference with: PJP-2002-00731, PJP200200729, PJP200200749, PJP200200742, PJP200200741, PJP200200720, PJP200200745, PJP200200690, PJP200200743.									U	11/07/2002	11/07/2002	0		UNK	UNK	NONE		NONE		PJP200200744	1						1	Medication error	FLU3~EVANS VACCINES~E32072GA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233966	02/17/2005					F	08/22/2003	A report was received from a health care professional on 08Nov02, concerning a female vaccinee who inadvertently received Fluvirin SC on 07Nov02. On 07Nov02 the vaccinee received 0.5ml Fluvirin SC. No adverse reaction was reported in relation to the incident. There was insufficient information to determine the reporter's causality assessment. Cross reference with: PJP200200731, PJP200200690, PJP200200728, PJP200200743, PJP200200729, PJP200200742, PJP200200741, PJP200200720.									U	11/07/2002	11/07/2002	0		UNK	UNK	NONE		NONE		PJP200200745	1						1	Medication error	FLU3~EVANS VACCINES~E32072GA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233968	02/17/2005			85		F	08/22/2003	A report received from a healthcare professional on 08Nov02, concerning an 85 year old female vaccinee who received Fluvirin on 08Nov02, 15 days after receiving another influenza vaccine (brand unspecified) on 24Oct02. On 24Oct02 the vaccinee received one dose of influenza vaccine (brand unspecified) at a doctor's office outside of the nursing home. The vaccinee did not report this vaccination to the medical staff at the nursing home and on 08Nov02 the vaccinee inadvertently received Fluvirin at the nursing home. The vaccinee did not experience any adverse event. The reporter has assessed the relationship of the vaccine to the event as unclassifiable.									U	11/08/2002	11/08/2002	0		UNK	UNK			NONE		PJP200200747	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0233974	02/17/2005	VA	62.0	61		F	01/06/2005	Left upper arm area size of 3 1/2 x 4 raised reddened warm area. Dr took pt home. Benadryl 25mg and 1 Tylenol at 11AM. 2pm felt tachycardia 117/71 p87 2:55pm 120/80 p 84.									U	01/05/2005	01/06/2005	1		PUB	UNK	NONE	NONE	PCN, Macrobid, Demerol		VA05001	1						1	Feeling hot; Injection site erythema; Injection site swelling; Tachycardia	FLU3~SANOFI PASTEUR~U1559BA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233975	02/17/2005	SC	30.0	29		F	02/12/2005	Where the shot was given the arm swole up the size of a baseball. I could not move it, it had fever in it. Could not move or touch the arm for 4 days. It was extremely painful.									Y	02/09/2005	02/09/2005	0		PUB	PUB	NONE	NONE	NONE			1						1	Feeling hot; Hypokinesia; Injection site oedema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~4~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0233976	02/17/2005	CA		5		F	02/11/2005	Erythema induration of right upper arm where shots given. Also tender to touch.									U	02/09/2005	02/10/2005	1		PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site mass; Tenderness	DTAP~GLAXOSMITHKLINE BIOLOGICALS~639B2~5~~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1449AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1240~4~~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1299N~2~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0233977	02/17/2005	WI	47.0	46		F	11/10/2004	NONE Report received 02/21/2005: Mouth itchy, flushed skin, later had prolonged allergic reaction; symptoms persisted till 11/02/2004.  Treated wtih Benadryl, Tagamet.				Y					Y	10/26/2004	10/26/2004	0		PVT	PVT	Celebrex, Nordette		Allergic Codiene/Gluten, Celiac Dx.			1						1	Flushing; Hypersensitivity; Stomatitis; Unevaluable event	FLU3~SANOFI PASTEUR~U1425AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0233978	02/17/2005	AL	50.0	50		U		10:10 flushed face, lighted headedness, nausea, perfuse perspiration, rapid pulse. Administered 0.3mg Epinephrine sq elevated feet.									Y	01/28/2005	01/28/2005	0		PUB	UNK		NONE			AL0501	1						1	Dizziness; Flushing; Heart rate increased; Hyperhidrosis; Nausea	FLU3~SANOFI PASTEUR~U1579AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0233979	02/17/2005	TX	42.0	41		F	02/10/2005	40 y/o female s/p smallpox vaccine left outer deltoid area 01Feb05; c/o vaccine area redness, swelling and heat and tenderness x 5 days, area of redness measures 14cm-16cm by 11-13cm				Y					N	02/01/2005	02/07/2005	6	Exam only-no lab	OTH	MIL	NONE	NONE	NONE			1						1	Feeling hot; Injection site erythema; Injection site oedema; Tenderness	FLU3~SANOFI PASTEUR~U1505AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020072~1~SC~RA~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0234009	02/17/2005	GA	76.0	76		M	02/17/2005	Guillain Barre Syndrome. Onset on symptoms 1/23/05. Increased CSF protein. Progressed to respiratory failure - BIPAP 1/31. Currently in ICU; quadriplegic.  4/25/05 Progress note from Neuro states confirmation of GBS based on unfinished EMG report. An earlier evaluation discusses pt's condition in the earlier stages of the syndrome, physical findings and suggests a course of diagnostic testing to better establish complete Dx.   Additional records include Progress noted documentation of respiratory failure, intubation & mechanical ventilation.  Consults relating to evaluating GI hemorrhage, evaluation of respiratory failure, Evaluation of possible radiation damage causing neurologic changes(negative). Multiple lab values tracking glucose, H&H levels primarly, chemistries and on pg 48, report of CSF with protein elevated at 68. Other documents include GI evaluations and initial EMG report.  Exam revealed areflexia & subacute quadriparesis.  Tx w/plasmapheresis.     From Neuro office; 04/26/05 Followup note from Neurologist stating confirmed GBS Dx; discusses course of pt care at Hospital and Rehab Center and addresses other medical conditions included in the pt's diagnosis.  Pt  has had barium swallow studies more associated w throat CA and continues on PEG tube feeding; swallowing continues poor dispite all manuvers.			Y						N	11/17/2004	01/23/2005	67	Information from medical records states h&h decreased, hyperglycemia.  CSF protein 68(H).	MIL	OTH		Vocal cord cancer.	vocal cord cancer, s/p chemo & radiation therapy Information from medical records states GERD, HTN, diabetes, hypercholesteromia, diverticulitis, castritis, cronic obstructive pulmonary disease, athersclerotic cardiovascular disease, smoker.			1						1	Gastrointestinal haemorrhage; Guillain-Barre syndrome; Haematocrit decreased; Hyperglycaemia; Quadriplegia; Respiratory failure	FLU3~SANOFI PASTEUR~U1461CA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0231245	02/18/2005	NY	63.0			M	02/18/2005	Pt. suffered from numbness in the extremities approximately 1 hour after receiving the flu vaccine. The numbness progressed and the patient was admitted to the ICU. A diagnosis of Gullain-Barre Syndrome was made and IV immune globulin therapy was initiated. The patient was transferred out. REcieved from discharge summary 12/29/05weakness				Y	Y				U					UNK	UNK		Additional terms from medical records on 12/29/05 cough increased, pharengitis.	Pt. had a viral URI approximately 1 week prior to vaccination. Recieved from Medcal records on 12/29/05 mitral valve repair, hypertension, dyslipidemia, myelopathy.			1						2	Asthenia; Guillain-Barre syndrome; Hypoaesthesia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0231361	02/18/2005	MI	60.0	59		F	02/14/2005	Started to experience left sided facial numbness, drooping and slurred speech went to her local ER for care/evaluation.Follow up 03/03/05: Main symptoms of adverse event were numbness of tongue, couldn't open mouth, face assymetrical. The happened 4 days after vaccination. Patient was diagnosed with peripheral 7th nerve palsy.				Y					U	11/30/2004	12/03/2004	3		OTH	OTH		NONE	NONE			1						2	Dysarthria; Facial palsy; Hypoaesthesia	FLU3~SANOFI PASTEUR~U1461CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0233336	02/18/2005	MO	8.0	7		F		This is a non serious spontaneous case from a consumer involving hives. The reporter causality is probably related to FluMist. This case is submitted according to the safety surveillance accelerated reporting agreement for FluMist. A 7 year old female pt received FluMist on 26Jan05. On 28Jan05, the pt developed hives which first appeared on both lower legs. She was self medicated with Benadryl (diphenhydramine) cream by her mother, but the hives continued to progress to her face, chest and back. She was brought to the doctor's office where she was given a steroid shot which cleared about 75% of the hives at that time but has continued to resurface later. As of 07Feb05 the pt had not recovered from this event and continued to apply dexamethasone/benadryl cream to relieve her of itchiness. The mother claimed that pt has no known food or drug allergies. On 09Feb05 the pt went to an allergist. She received ranitidine hydrochloride, cetirizine hydrochloride, and hydroxyzine hydrochloride for treatment. The events resolved on an unk date. The mother stated that she feels the FluMist could have possibly caused the hives due to the proximity of the date of vaccination and onset of symptoms.									N	01/26/2005	01/28/2005	2		PUB	PUB	NONE		NONE		MEDI0002852	1						2	Urticaria; Pruritus; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500339P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500339P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0233834	02/18/2005		63.0	62		F	02/15/2005	Information has been received from a nurse practitioner concerning a 63 year old female patient with a history of breast cancer (2003) and allergy to nonestrogen who on 10/14/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # unknown). Concomitant secondary suspect vaccination include a dose of influenza virus vaccine in the same arm at the same time. Other concomitant therapies included simvastatin and levothyroxine Na. On 10/14/04, within 12 hours, it was reported that the patient's whole left arm and fingers became swollen The doctor treated her with ibuprofen, ice and elevation to the injection site. On 10/15/04, the patient was seen by the doctor who saw no swelling but the patient reported pain from her shoulder to elbow. She was given methylprednisolone, 30mg decreasing to 10mg. It was reported that she was seen again in the office on 10/21/04 and given triamcinolone acetonide for tendonitis. The physician called the patient on 10/26/04 and she reported that she was 80% improved. It was also reported that the patient began physical therapy on 11/8/04 and she was not getting better by 12/17/04. The patient was given triamcinolone acetonide, 40mg and a MRI was scheduled. On 12/26/04, the patient was diagnosed with  an anterior tear of tendon and arthritic changes. It was reported that the patient was not recovered. It was also reported that the patient was scheduled for surgery in February to repair the tear. Upon internal review, the patient's adverse experience is considered to be an important medical event (OMIC). There was no product quality complaint involved. Additional information has been requested.				Y					N	10/14/2004	10/14/2004	0	MRI 12/26/04, Anterior tear of tendon and arthritic changes	OTH	OTH	Synthroid; Zocor		Breast Cancer and Drug Hypersensitivity.		WAES0502USA00876	1						2	Oedema peripheral; Pain; Red blood cell sedimentation rate increased; Shoulder pain; Tendon rupture; Tendonitis; Arthritis; Injection site swelling; Laboratory test abnormal; Oedema peripheral; Pain; Tendon rupture; Tendonitis	FLU3~SANOFI PASTEUR~U1488AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~656UN~2~IM~LA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~2~~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0234019	02/18/2005	CO	59.0	59		F	02/14/2005	Had flu shot on 10/08/2003. Got sick 10/10/2003. Headache, heavy coughing, Drowning sensation. Spine felt like hit with ice cold axe. exhaustion, and extreme shortness of breath. Shortened my life. Follow Up: Pt is a 59 year old woman who experienced intermittent chest discomfort and profound shortness of breath over the last couple of weeks since she got her flu shot. She has a history of dyslipidemia and hypertension. She had a symptomatic but electrically uneventful adenosine phase with a lot of flushing and symptoms associated with vasodilation. She had no EKG changes and no arrhythmia. She had a left bundle branch block as the baseline EKG tracing which precipitated the adenosine test. She was recovered to baseline and stable on transfer to nuclear medicine for follow up imaging.  Medical Records states pharyngitis. msv			Y		Y			Y	Y	10/08/2003	10/10/2003	2	Medical records states abnormal lab tests, abnormal EKG. msv	PVT	UNK		NONE	NONE Medical records state COPD, melanoma, hypertension, depression, allergy. msv			1						1	Back pain; Cough; Dyspnoea; Electrocardiogram abnormal; Fatigue; Headache; Laboratory test abnormal; Pharyngitis	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0234021	02/18/2005	TX	0.76	0	.8	F	01/27/2005	Fever 103.9, shaking (not seizure type), shallow breathing. Took to the ER followed up 1/26/05 with private physician. Doctor said she had an inner ear infection and URI and possible asthma, gave antibiotic and instr. to alternate Motrin and Tylenol every 4 hrs.				Y					N	01/20/2005	01/22/2005	2		OTH	PUB		NONE			TX05008	1						1	Asthma; Hypoventilation; Otitis media; Pyrexia; Tremor; Upper respiratory tract infection	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~21932B2~4~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1439AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE398AA~4~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A74404F~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0234050	02/18/2005	CA	74.0	74		F	02/18/2005	Fever (103F) chills within 3 of vaccine assessed, following AM. Tx with OTC Tyl prn. Time course: 3 days.				Y					Y	12/30/2004	12/30/2004	0		PUB	UNK		NONE	Diverticulitis with resection c2001, Allergy PCN			1						1	Chills; Pyrexia	FLU3~SANOFI PASTEUR~U1549AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0234051	02/18/2005	NJ	79.0	78		F	02/18/2005	12/03/2004 Flu shot gA By 12 P on 12/03/2004 arm at site swollen, slight nausea. Evening 12/03/2004 upper left arm swollen, painful, headache, nausea. Self medicated with tylenol. 12/04-12/05 in bed because of HA, nausea, throbbing arm. 12/06 out of bed, packed up for trip. Sequence of adverse events, signs and symptoms, treatment. The following is an account by the patient given 02/18/2005. 12/03/04 Within hour of injection, site became red and tender, By three hours, her left upper arm was hard and swollen and she began to experience headaches and nausea (w/o vomiting). She self medicated with Tylenol and remained in bed 12/04-12/05 with continuing symptoms of headache, nausea and throbbing arm. On 12/06, she got out of bed to pack for pre-arranged trip to, On 12/08, she left for her trip. Up to this point she had not sought medical attention, On 12/08, she was seen by a physician (house call). At this point she was complaining of severe nausea and headache. Her arm swelling was down, but still painful. Treatment by MD : A shot for nausea. On 12/09 she was experiencing 1/2 facial drooping on the left side and was unable to open her left eyelid. On 12/10, she was referred to an Ophthalmologist who dx'd optic nerve involvement and made an emergency consult to a Neurologist. The neurologist prescribed mega doses of B1, B6, B12 and Gingko tablets and arranged for an MRT. Symptoms at this time included diplopia, balance difficulty and headache. On 12/12 she had a doppler of the head and neck. A diagnosis of Fisher Barre' was given. The Neurologist advised her to see her private physicain in the US two weeks after  she returned for follow up. On 01/18 she returned to the US. On 02/04 she was seen by a MD. A referral was made to  Ophthalmologist, who directed her to continue the prescription and exercises. She has a return visit scheduled with MD on 03/15.				Y					N	12/03/2004	12/03/2004	0		PUB	UNK	2 for asthma		Penicillin, asthma	swelling at site~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Coordination abnormal; Diplopia; Eyelid oedema; Facial palsy; Headache; Injection site erythema; Injection site swelling; Nausea; Optic neuritis; Pain; Tenderness	FLU3~SANOFI PASTEUR~U1521AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0192804	02/22/2005		43.0	43		F	08/22/2003	A report received from a health care professional on 02Dec02, concerning a 43 year old female vaccinee who experienced chest tightness, difficulty breathing and muscle tenseness in the neck and shoulder region after receiving Fluvirin on 31Oct02. On 31Oct02, the vaccinee experienced chest tightness, difficulty breathing and muscle tenseness in the neck and shoulder region within approx 30 minutes of receiving Fluvirin. The vaccinee was brought to an emergency dept approx 3.5 hours after vaccination. However, by the time the vaccinee was seen in the emergency dept the symptoms had subsided and no treatment was administered. At the time of reporting the vaccinee had fully recovered with no sequelae. The vaccinee has received unspecified influenza vaccinations for approx the past 4-5 years with no prior adverse reactions. The reporter has assessed the relationship of the vaccine to the event as probable. Update 1, 31Jan03: A follow up report was received from a health care professional. The vaccinee received Fluvirin at 9:25 on 31Oct02. At 9:45 the vaccinee experienced a stiff neck at 10:15 she experienced a tightness in her throat, at 10:30 she experienced a tightness in her chest and at 10:45 she experienced a pressure/weight on her chest making it difficult for her to breathe. The event was reported as life threatening and required medical/surgical intervention. The vaccinee was transported to an ER for observation. The events resolved on the 31Oct02.									U	10/31/2002	10/31/2002	0		UNK	UNK	Novalog Insulin 1971, Zocor Apr 2002 20mg once a day, Aspirin 2001 325mg		Type 1 diabetes mellitus (1970-ongoing), mitral valve prolapse (ongoing), stroke (CVA) (1982 no residual), laryngitis.		PJP200200847	1						2	Chest discomfort; Dyspnoea; Musculoskeletal stiffness; Throat tightness	FLU3~EVANS VACCINES~E34662HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0194828	02/22/2005		36.0	36		F	08/22/2003	A report was received from a health care professional on 26Nov02 concerning a 36 year old female vaccinee who experienced left facial numbness after receiving Fluvirin on 06Nov02. On 06Nov02 the vaccinee experienced facial numbness on the left side of her face extending from the middle of the cheek to her upper lip. The vaccinee underwent an MRI scan which was normal. The treating ENT physician stated that the numbness affected the trigeminal nerve. The numbness had not resolved at the time of the report. The reporter has assessed the relationship of the vaccine to the event as possible.									U	11/06/2002	11/06/2002	0		UNK	UNK	NONE		NONE		PJP200200820	1						2	Hypoaesthesia; Trigeminal neuralgia	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0234067	02/22/2005		26.0	25		F	08/22/2003	A report was received from a healthcare professional on 11Nov02 concerning a 25 year old female vaccinee who experienced an increased WBC count and was 30 weeks pregnant when she received Fluvirin on 08Nov02. On 08Nov02 the vaccinee was 30 weeks pregnant and received 0.5ml Fluvirin IM. On 11Nov02 the reporter ( a nurse) ordered a complete blood count test and noticed that the WBC was increased to 20.8. The clinics protocol specifies 4.0-11.0 as normal. It was reported that the vaccinee did not experience any adverse reaction. The vaccinee had not been vaccinated prior to this event. The reporter has classified the relationship of the event to the vaccine as possible.									U	11/08/2002	11/11/2002	3		UNK	UNK	NONE		Pregnant		PJP200200752	1						1	Unintended pregnancy; White blood cell count increased	FLU3~EVANS VACCINES~E34682HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234068	02/22/2005		20.0			M	08/22/2003	A report was received from a consumer on 12Nov02 concerning a 20 year old male vaccinee who experienced hives and flu-like symptoms including fever and aches after receiving Fluvirin on 07Nov02. On 08Nov02, the vaccinee experienced hives and flu-like symptoms after receiving Fluvirin on 07Nov02. On 09Nov02 the vaccinee sought medical attention at an infirmary. The vaccinee was injected with diphenhydramine and released. Symptoms continued at the time of the report. The vaccinee was reported to be allergic to the sulfa drugs.									U	07/11/2002	11/08/2002	120		UNK	UNK	Albuterol, Advair		NONE		PJP200200756	1						1	Hypersensitivity; Influenza like illness; Myalgia; Urticaria	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234069	02/22/2005		10.0			F	08/22/2003	A report was received from a healthcare professional on 12Nov02 concerning a 10 year old female vaccinee who experienced redness, swelling, purple discoloration and tenderness around the injection site within 1 day of receiving Fluvirin on 08Nov02. On 09Nov02 the vaccinee experienced redness, swelling, purple discoloration and tenderness within 1 day of receiving Fluvirin. Symptoms included redness, swelling, purple discoloration and tenderness of an 8cm area around the injection site. The symptoms were relieved by Benadryl topical cream and cold compress. On 11nov02 the vaccinee had not yet recovered. The vaccinees father indicated that the vaccinee received an influenza vaccine (brand unspecified) on the previous year and experienced a mild local reaction at the injection site. The reporter has assessed the relationship of the vaccine to the event as probable.									U	11/08/2002	11/09/2002	1		UNK	UNK	Anti asthmatic drugs		NONE		PJP200200757	1						1	Injection site erythema; Injection site oedema; Similar reaction on previous exposure to drug; Skin discolouration; Tenderness	FLU3~EVANS VACCINES~E35712KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234070	02/22/2005		64.0			M	08/22/2003	A report was received from a healthcare professional on 12Nov02 concerning a 64 year old male vaccinee who experienced chills immediately after receiving Fluvirin and developed Balls Palsy 3 days after vaccination on 02Nov02. Immediately after receiving 0.5ml Fluvirin IM the vaccinee experienced chills which resolved on an unreported date. 3 days after receiving Fluvirin the vaccinee developed Bells Palsy with drooping of the left eye and the left side of the face and lips. Symptoms had not resolved at the time of the report. There was insufficient information to determine the reporter's causality assessment.									U					UNK	UNK	Anti hypertensive medications		NONE		PJP200200758	1						1	Chills; Facial palsy	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234071	02/22/2005		9.0			M	08/22/2003	A report received from a parent of a consumer on 11/12/2002, concerning a 9 year old vaccinee who experienced insomnia within days of receiving Fluvirin on 11/01/2002. The vaccinee experienced insomnia within days of receiving Fluvirin. the vaccinee experienced difficulty in falling asleep on 3 different occasions (dates unknown). Nothing had changed in the vaccinee's daily routine or medications. At the time of reporting, the vaccinee had not yet recovered.									N	11/01/2002	11/01/2002	0		UNK	UNK	Insulin		Juvenile onset diabetes		PJP200200759	1						1	Insomnia	FLU3~EVANS VACCINES~~2~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234072	02/22/2005		2.17			F	08/22/2003	A report was received from a health care professional on 11/13/2002, concerning a 26 month old female vaccinee who was inadvertently administered Fluvirin on 11/13/2002. On 11/13/2002, the vaccinee was inadvertently administered Fluvirin subcutaneously instead of polio vaccine. The vaccinee had not received any previous influenza vaccinations. The vaccinee did not experience any adverse reactions. There was insufficient information to determine the reporter's causality assessment. Update 1 01/27/2003 - A report was received from a health care professional concerning a vaccinee of less than 6 months old who experienced a mild temperature and slight tenderness at the injection site after receiving Fluvirin.									U	11/13/2002	11/13/2002	0		UNK	UNK					PJP200200764	1						1	Medication error; Pyrexia; Tenderness	FLU3~EVANS VACCINES~E31182GA~2~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234073	02/22/2005		48.0	48		M	08/22/2003	A report received from a health care professional on 11/13/2002, concerning a 48 year old male vaccinee who experienced an erythematous maculo-papular rash, low grade fever and myalgia 4 days after receiving Fluvirin on 11/08/02. On 11/12/02, the vaccinee experienced an erythematous maculo-papular rash, low grade fever and myalgia 4 days after receiving Fluvirin. The erythematous maculo-papular rash developed all over his body. The vaccinee was treated with Tylenol and Benadryl (OTC strength). At the time of reporting the vaccinee had not yet recovered. The reporter has assessed the relationship of the vaccine to the event as probable and that the vaccinee experienced a hypersensitivity to Fluvirin.									N	11/08/2002	11/12/2002	4		UNK	UNK	Concomitant Drug Not Used.		No risk factors reported. Sarcoidosis (inactive)  Previously received the influenza vaccine for years without a problem. The vaccinee was not hypersensitive to eggs and other products.		PJP20020765	1						1	Myalgia; Pyrexia; Rash erythematous; Rash maculo-papular	FLU3~EVANS VACCINES~E35452HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234074	02/22/2005		62.0			F	08/22/2003	A report received from a health care professional 11/13/2002, concerning a 62 year old vaccinee who experienced sneezing and malaise 3 hours after receiving Fluvirin on 11/12/2002. On 11/12/2002, the vaccinee experienced sneezing and malaise 3 hours after receiving Fluvirin. The reporter indicated that the vaccinee started sneezing similar to symptoms of an allergic reaction 2 hours after receiving the vaccine. Furthermore, the vaccinee developed a general feeling of malaise that accompanied the sneezing. On 11/13/2002, 24 hours after the onset of the event, the sneezing and malaise spontaneously resolved without treatment. The reporter has assessed the relationship of the vaccine to the event as possible.									Y	11/12/2002	11/12/2002	0		UNK	UNK	Cozaar		Hypertension , porphyria		PJP200200766	1						1	Malaise; Sneezing	FLU3~EVANS VACCINES~E30442GA~2~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234075	02/22/2005		67.0			F	08/22/2003	A report was received from a health care professional on 11/13/2002 concerning a 67 year old female vaccinee who was inadvertently administered last years (2001) batch of Fluvirin on 11/13/2002. On 11/13/2002 the vaccinee received 0.5 ml of the 2001 batch of Fluvirin intramuscularly. No adverse reaction was reported in relation to the incident. The reporter has assessed the relationship of the event to the vaccine as related.									Y	11/13/2002	11/13/2002	0		UNK	UNK					PJP200200760	1						1	Medication error	FLU3~EVANS VACCINES~~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234076	02/22/2005		29.0	29		F	08/22/2003	A report from a health care professional on 11/08/02, concerning a 29 year old female vaccinee who inadvertently received 0.5 mil Fluvirin with a TB syringe and may have received the vaccinee subcutaneously on 11/11/02. The reporter speculated that the vaccinee may have received Fluvirin via the subcuataneous route. The vaccinee did not experience any adverse events. There was insufficient information to determine the reporter's causality assessment.									U	11/11/2002				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200200769	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234077	02/22/2005		38.0	38		M	08/22/2003	A report received from a health care professional on 11/08/2002, concerning a 38 year old male vaccinee who inadvertently received 0.5 ml Fluvirin with a TB syringe and may have received the vaccine subcutaneously on 11/11/2002. On 11/11/2002, the vaccinee was administered Fluvirin with a TB syringe. The reporter speculated that the vaccinee may have received the Fluvirin via the subcutaneous route. The vaccinee did not experience any adverse events. There was insufficient information to determine the reporter's causality assessment.									U	11/11/2002	11/11/2002	0		UNK	UNK					PJP200200770	1						1	Medication error	FLU3~EVANS VACCINES~~2~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234078	02/22/2005		45.0	45		F	08/22/2003	A report was received from a distributor on 11/13/02, concerning a 45 year old female vaccinee who experienced a aching arm, felt unwell and broke out in red hives on her legs, chest, lower back and neck after receiving Fluvirin on 11/06/02. On 11/06/02, the vaccine received a pneumonia shot in her left arm and a flue vaccine in her right arm. Later that evening she experienced a pain in her right arm. On 11/07/02 the vaccinee did not feel well all day. On 11/08/02 she broke out in red hives on her legs, chest, lower back and neck. The vaccinee was treated by a doctor and was given an injection of Triamcinolone. She was also prescribed methylprednisolone and hydroxyzine. On 11/13/02, the vaccinee had fully recovered from the reaction. There was insufficient information to determine the reporter's causality assessment.				Y					Y	11/06/2002	11/07/2002	1		UNK	UNK	Concomitant Drug Not Reported.		No risk factors reported.		PJP200200773	1						1	Malaise; Pain; Urticaria	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0710M~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0234079	02/22/2005					F	08/22/2003	A report was received from a health care professional on 10/23/2002, concerning a female vaccinee of unknown age who inadvertently received frozen Fluvirin vaccine on 10/23/02. The vaccinee did not experience any adverse event. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200200585, PJP200200629 and PJP200200775. Update (1) 12/23/02: A follow up report received from a health care professional indicated that the event was resolved on an unspecified date.									U	10/23/2002				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200200774	1						1	Medication error	FLU3~EVANS VACCINES~E33482HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234080	02/22/2005					F	08/22/2003	A report was received from a health professional on 10/23/2002, concerning a female vaccinee of unknown age who inadvertently received frozen Fluvirin vaccine on 10/23/2002. The vaccine did not experience any adverse event. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200200585, PJP200200629 and PJP200200774. Update (1) 12/23/2002: A follow up report received from a health care professional indicated that the event was resolved on an unspecified date.									U	10/23/2002				UNK	UNK	Concomitant Drug Not Reported.		No risk factors reported.		PJP200200775	1						1	Medication error	FLU3~EVANS VACCINES~E33482HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234081	02/22/2005					U	08/22/2003	A report received from a health care professional on 11/15/02, concerning three vaccinee's of less than 4 years of age who were inadvertently administered Fluvirin on an unknown date. It was unknown whether or not any of the vaccinee's experienced an adverse event. There was insufficient information to determine the reporter's causality assessment.									U					UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP20020799	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234082	02/22/2005		21.0	20		F	08/22/2003	A report received from a health care professional on 11/15/02, concerning a female vaccinee who was inadvertently administered 9.5 ml of Fluvirin on 11/15/02. No adverse symptoms were reported. There was insufficient information to determine the reporter's causality assessment. Update (1) 01/07/03: A follow up report from a health care professional which indicated that the vaccinee was 20 years of age. The vaccinee inadvertently self administered 9.5 ml of Fluvirin. The vaccinee did not experience any adverse reactions.									U	11/15/2002				UNK	UNK	Concomitant Drug Not reported		No risk factors reported		PJP200200791	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234083	02/22/2005		50.0			F	08/22/2003	A report received from a health care professional on 11/18/02, concerning a 50 year old female vaccinee who experienced an injection site reaction after receiving Fluvirin on 10/22/02. On 10/22/02, the vaccinee experienced an injection site reaction after receiving Fluvirin on the same day. Symptoms included a 2-3 inch area of redness, swelling and warmth at the site of injection. The vaccinee was treated with diphenhydramine cream for 1 day, and the event resolved after one week. There was insufficient information to determine the reporter's causality assessment.									U	10/22/2002	10/22/2002	0		UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP20020792	1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234084	02/22/2005		81.0			F	08/22/2003	A report was received from a health professional on 11/18/02, concerning an 81 year old female who experienced a rash under both breast after receiving Fluvirin on 11/15/02. The event occurred on 11/16/02 or 11/17/02. At the time of reporting the vaccinee had not yet recovered. There was insufficient information to determine the reporter's causality assesement.									N	11/15/2002				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported. Hypertension and Diabetes		PJP200200793	1						1	Rash	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234085	02/22/2005		24.0			F	08/22/2003	A report was received from a health care professional on 11/18/02 concerning a 24 year old female vaccinee who experienced itching all over the body and a rash on the face 1 day after receiving Fluvirin on 11/15/02. The vaccinee was reported to be recovering after treatment with diphenhydramine. There was insufficient information to determine the reporter's causality assessment. Cross reference with: PJP200200793, PJP200200792 and PJP200200795.									U	11/15/2002	11/16/2002	1		UNK	UNK	Concomitant Drug Not Used		No risk factors reported		PJP200200794	1						1	Pruritus; Rash	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234086	02/22/2005					U	08/22/2003	A report was received from a health care professional on 11/18/02 concerning a vaccinee of unknown demography who developed a rash after receiving Fluvirin on an unknown date. No further information was reported. There was insufficient information to determine the reporter's causality assessment. Cross reference with: PJP200200794, PJP200200793 and PJP200200792.									U					UNK	UNK	Concomitant Drug Not Used.		No risk factors reported		PJP200200795	1						1	Rash	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234087	02/22/2005					U	08/22/2003	A report was received from a health care professional on 11/18/02 concerning a group of vaccinees who were inadvertently administered 0.5ml Fluvirin subcutaneously on unreported dates. The reporter has assessed the relationship of the event to the vaccine as unclassifiable.									U					UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200200796	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234088	02/22/2005		46.0			F	08/22/2003	A report was received from a health care professional on 11/18/02, concerning a 46 year old female vaccinee, who was also a health care professional, who experienced muscle degradation and pain at the injection site 7 days after receiving Fluvirin on 10/30/02. On 11/06/02, the vaccinee experienced muscle degradation and pain at the injection in the left deltoid muscle. The degradation was reported to be worsening, involving an area of 5cm. In 1998 the vaccinee was reported to have had a similar experience after receiving influenza virus vaccine (brand unspecified). However, the vaccinee was reported to have tolerated influenza vaccinee (brands unspecified) in the past. The reporter has assessed the relationship of the event to the vaccine as possible.									U	10/30/2002	11/06/2002	7		UNK	UNK	Concomitant Drug Not Used		No risk factors reported. In 1998 the vaccinee experienced a similar reaction to an influenza virus vaccine, however the vaccinee has also tolerated influenza virus vaccinee in the past.		PJP200200797	1						1	Injection site pain; Muscle atrophy	FLU3~EVANS VACCINES~E33502HA~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234089	02/22/2005					U	08/22/2003	A report was received from a health care professional on 19Nov02 concerning a group of less than 10 vaccinees all less than 4 years old who were inadvertently administered Fluvirin on various unreported dates. On unreported dates less than 10 vaccinees less than 4 years were inadvertently administered Fluvirin. No adverse reaction was reported. There was insufficient information to determine the reporter's causality assessment.									U					UNK	UNK	NONE		NONE		PJP200200798	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234090	02/22/2005					F	08/22/2003	A report received from a health care professional on 20Nov02, concerning a female vaccinee who inadvertently received Fluvirin SC on 20Nov02. On 20Nov02, the vaccinee was inadvertently administered Fluvirin SC. No adverse symptoms were reported. There was insufficient information to determine the reporters causality assessment.									U	11/20/2002	11/20/2002	0		UNK	UNK	NONE		NONE		PJP200200799	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234091	02/22/2005					F	08/22/2003	A report was received from a healthcare professional on 11/20/2002 concerning a female vaccinee who was inadvertently administered 0.1ml Fluvirin subcutaneously on 11/20/2002.  On 11/20/2002 the vaccinee was inadvertently administered 0.1ml Fluvirin subcutaneously instead of a PPD test.  No adverse effect was reported. There was insufficient information to determine the reporter's causality assessment.									U	11/20/2002	11/20/2002	0		UNK	UNK	Concomitant drug not used.		No risk factors reported.		PJP200200800	1						1	Medication error	FLU3~EVANS VACCINES~E3392HA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234092	02/22/2005		66.0	66		F	08/22/2003	A report was received from a health professional on 11/21/2002, concerning a 65 year old female vaccinee who experienced upper extremity weakness, pain, swelling and tenderness from the site of administration at the deltoid muscle down to the fingertips, 16 days after receiving Fluvirin on 10/29/2002.  On 11/14/2002, the vaccinee's upper extremity became weak, painful, swollen and tender from the site of injection at the deltoid muscle down to the fingertips.  The vaccinee went to the physician as a result of this event, and was prescribed oral anti-inflammatory medication.  The event had partially resolved at the time of reporting, but was still present.  The vaccinee did not received any other injections in the affected upper extremity either before or after the Fluvirin injection.  The vaccinee has received Fluvirin in previous years without any adverse or untoward event.  The vaccinee has no known medciation or other allergies.  The reporter has assessed the relationship of the vaccine to the vent as probable.  Update 1, 12/10/2002:  An update report received from a healthcare professional indicated that the vaccinee did not experience soreness, swelling, redness or bruising at the injection site.  However, 16 days after receiving Fluvirin, the vaccinee experienced pain in the right arm to touch and was having difficulty lifting her right arm.  The vaccinee was treated with 7.5mg melocain bid.  At the time of reporting the vaccinee had not yet recovered.  The vaccinee's physician suggested that the event was an adverse reaction to the Fluvirin.				Y					U	10/29/2002	11/14/2002	16		UNK	UNK	Calcium, Conera	C	No risk factors reported.		PJP200200801	1						1	Injection site pain; Muscular weakness; Swelling	FLU3~EVANS VACCINES~E37182KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0234093	02/22/2005		54.0			M	08/22/2003	A report was received from a healthcare professional on 11/21/2002, concerning a 54 year old male vaccinee who experienced an injection site reaction after receiving Fluvirin on 11/19/2002. On an unknown date the vaccinee experienced an injection site reaction after receiving Fluvirin on 11/19/2002.  The vaccinee's upper arm became red and swollen, and the area around the injection site was swollen.  At the time of reporting the outcome of the event was unknown. There was insufficient information to determine the reporter's causality assessment.									U	11/19/2002				UNK	UNK	Concomitant drug not reported.		No risk factors reported.		PJP200200803	1						1	Erythema; Injection site reaction; Injection site swelling	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234094	02/22/2005		10.0	10		M	08/22/2003	A report was received from a healthcare professional who is also the vaccinee's father on 11/22/2002 concerning a 10 year old male vaccinee who experienced an upper respiratory cough and fever 2 days after receiving Fluvirin on 11/19/2002.  On 11/21/2002 the vaccinee began to experience an upper respiratory cough and a mild fever.  The vaccinee had been exposed to other people with coughs and colds.  At the time of the report the vaccinee had not recovered. The reporter has assessed the relationship of the vaccine to the event as unrelated.  The reporter indicated that a possible reason was the vaccinee's exposure to other children experiencing similar symptoms and not due to Fluvirin.									U	11/19/2002	11/20/2002	1		UNK	UNK	Concomitant drug not used.		No risk factors reported.		PJP200200804	1						1	Cough; Pyrexia	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234095	02/22/2005					M	08/22/2003	A report was received from a healthcare professional on 11/22/2002 concerning a group of vaccinees less than 4 years old of unknown sex who inadvertently received Fluvirin from approximately 11/07/2002 onwards.  From 11/07/2002 Fluvirin was administered to vaccinees less than 4 years old.  There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/10/2002: A follow report was received from a healthcare professional on 12/10/2002 indicating that an 11 month old male vaccinee was inadvertently administered Fluvirin intramuscularly on 11/12/2002.									U	11/12/2002	11/12/2002	0		UNK	UNK	Concomitant drug not used.		No risk factors reported.		PJP200200805	1						1	Medication error	FLU3~EVANS VACCINES~E3573HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234096	02/22/2005		78.0			M	08/22/2003	A report was received from a health care professional on 21Nov02 concerning a eleven vaccinees between the ages of 56 and 84 years who were inadvertently administered 1ml of Fluvirin on an unreported date. On an unreported date a eleven vaccinees were inadvertently administered 1ml of Fluvirin. No adverse reaction was reported. There was insufficient information to determine the reporter's causality assessment. Update 1 31Dec02: A follow up report was received from a health care professional indicating that a 78 year old male vaccinee was inadvertently administered 1.0ml of Fluvirin on 21Nov02. Cross reference with: PJP200200906, PJP200200905, PJP200200904, PJP200200903, PJP200200902, PJP200200901, PJP200200900, PJP200200899, PJP200200898, PJP200200907.									U	11/21/2002	11/21/2002	0		UNK	UNK	NONE		NONE		PJP200200806	1						1	Medication error	FLU3~EVANS VACCINES~E37182KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234097	02/22/2005		57.0	57		F	08/22/2003	A report was received from a healthcare professional on 25Nov02, concerning a 57 year old female vaccinee who experienced a blister at the injection site 8 days after receiving a Fluvirin injection in the right deltoid on 12Nov02. On 20Nov02 the vaccinee reported a blister at the injection site which scabbed over and had resolved at the time of reporting. The reporter has assessed the relationship of the vaccine to the event as probable.									U	11/12/2002	11/20/2002	8		UNK	UNK	NONE		NONE		PJP200200814	1						1	Injection site vesicles	FLU3~EVANS VACCINES~E37182KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234099	02/22/2005		67.0			F	08/22/2003	A report was recieved from a consumer on 27Nov02, concerning a 67 year old female vaccinee who experienced blisters on her body within one week of receiving 0.5ml Fluvirin vaccine 0.5ml IM on 31Oct02. Within one week the vaccinee developed a severe outbreak of blisters on the body including the face, arms, legs and trunk. On 06 or 07Nov02 the vaccinee was seen by a physician who prescribed an unk antibiotic. On 14Nov02 the vaccinee was referred to a dermatologist who suggested that thimerosal in Fluvirin vaccine might have caused the adverse event. The dermatologist prescribed prednisone 5mg six times a day. On 21Nov, a culture was taken from the blisters. The culture results were not available at the time of reporting. On 25Nov02, the vaccinee had a follow up appt with the dermatologist, who subsequently increased the dose of prednisone to 40mg daily for 1 week. The vaccinee stated that prednisone had not relieved the symptoms and that she had applied unk antibiotic cream and foam to the blisters to reduce itchiness. According to the vaccinee her face looked and felt sunburned, scabs from the blisters were deep and large leaving some scars. The vaccinee also reported petechiae on both feet, legs and inside of forearms, but no local reaction at the injection site. The vaccinee had received the flu vaccine for at least 10 years without any problem and is not allergic to any medicine except Betadine. The vaccinee has used Nerthiolate for many years without any problem.									U	10/31/2002				UNK	UNK	Synthroid, Nexium, multivitamin, unspecified cataract medicine		NONE		PJP200200821	1						1	Blister; Petechiae; Pruritus; Sunburn	FLU3~EVANS VACCINES~E33492HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234100	02/22/2005					U	08/22/2003	A report received from a health care professional on 02Dec02, concerning an unk number of vaccinees aged between 6-35 months who were inadvertently administered Fluvirin. On unk dates between 21Oct02 and 02Dec02, an unk number of vaccinees aged between 6-35 months were inadvertently administered Fluvirin. The vaccinees were administered Fluvirin once if they had recieved it before and twice if they had not. No adverse symptoms were reported. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200300007.									U		10/21/2002			UNK	UNK	NONE		NONE		PJP200200824	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234101	02/22/2005					U	08/22/2003	A report received from a healthcare professional on 02Dec02, concerning an unk number of vaccinees of less than 4 years of age who were inadvertently administered Fluvirin. On unk dates, an unk number of vaccinees of less than 4 years of age were inadvertently administered Fluvirin. There was insufficient information to determine the reporter's causality assessment.									U					UNK	UNK	NONE		NONE		PJP200200825	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234102	02/22/2005		57.0	56		F	08/22/2003	A report was received from a consumer on 04Dec02 concerning a 56 year old female vaccinee who experienced neurological pain and twinges in her neck 2 hours after Fluvirin vaccination on 21Nov02. On 21Nov02, the vaccinee experienced neurological pain and twinges in her neck. The symptoms occurred periodically over the course of 10 days. The vaccinee self administered Advil analgesia and applied ice to the affected areas of neck. The events were not reported to her physician. At the time of the report the symptoms had subsided and the event had resolved.									U	11/21/2002	11/21/2002	0		UNK	UNK	NONE		The vaccinee had a vaccination approx 15 years previously.		PJP200200830	1						1	Muscle twitching; Neck pain; Neurological symptom	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234103	02/22/2005		60.0	59		F	08/22/2003	A report was received from a consumer on 04Dec02, concerning a 59 year old female vaccinee who experienced a pinched neck two days after receiving Fluvirin on 29Nov02. On 01Dec02 the vaccinee experienced a pinched neck. The vaccinee described the pain as muscular pain at the back of the neck, which was more evident upon bending. The vaccinee described the pain as still occurring but with a decreased severity. The vaccinee last received the influenza vaccine in Nov01 and did not recall as having a similar type of reaction.									U	11/29/2002	12/01/2002	2		UNK	UNK	NONE		NONE		PJP200200831	1						1	Neck pain	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234104	02/22/2005					U	08/22/2003	A report received from a health care professional on 06Dec02, concerning 30-40 vaccinees who experienced tapioca like objects in stools, mild fatigue, nausea and vomiting after receiving Fluvirin between October and November 2002. On 17Oct02 and 24Oct02, staff members at a long term care facility received Fluvirin and on 07Nov02, the residents at the facility received Fluvirin. Between 20-22 Nov02, 30-40 vaccinees experienced tapioca like objects in stools, mild fatigue, nausea and vomiting after receiving Fluvirin. The family members of the affected staff members also experienced the same symptoms. Tests on the stools, water system and other relevant equipment around the facility were negative for virus, parasite and bacterial contamination. The reporter indicated that the Fluvirin vaccine vials were left at room temp overnight, and then subsequently stored in a refrigerator until administration. The vaccinees have not yet recovered at the time of reporting. The reporter has assessed the relationship of the vaccine to the event as possible.									U	10/17/2002				UNK	UNK	NONE		NONE		PJP200200835	1						1	Fatigue; Medication residue; Nausea; Vomiting	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234105	02/22/2005		47.0			M	08/22/2003	A report was received from a health care professional on 09Dec02 concerning a 47 year old male vaccinee who experienced pain and weakness on the anterior, middle and posterior left deltoid 10 to 14 days after receiving Fluvirin in the week beginning 04Nov02. Ten to fourteen days after receiving 0.5ml Fluvirin IM on the 04Nov02 the vaccinee experienced pain and weakness on the anterior, middle and posterior left deltoid. At the time of reporting it was reported that 80% of the pain had resolved and the weakness had resolved completely. There was insufficient information to determine the reporters causality assessment.									U					UNK	UNK	NONE		NONE		PJP200200836	1						1	Asthenia; Injection site pain	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234106	02/22/2005		11.0			M	08/22/2003	A report was received from a health care professional on 09Dec02 concerning a 11 year old male vaccinee who experienced bilateral pain and weakness at the triceps which began 2 weeks after administration of Fluvirin in the week beginning 28Oct02. Two weeks after receiving 0.5ml Fluvirin IM in the week beginning on the 28Oct02 the vaccinee experienced bilateral pain and weakness at the triceps. Fluvirin was administered on the right deltoid. At the time of reporting it was reported that the pain and weakness had resolved 100%. There was insufficient information to determine the reporters causality assessment. Cross reference with: PJP200200836.									U					UNK	UNK	NONE		NONE		PJP200200837	1						1	Asthenia; Pain	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234107	02/22/2005		80.0	80		F	08/22/2003	A report was received from a health care professional on 09Dec02 concerning a 80 year old female vaccinee who inadvertently received a dose of Fluvirin on 20Nov02 and 08Dec02. On 20Nov02 and 08Dec02 the vaccinee received vaccinations of 0.5ml Fluvirin. No adverse reaction was reported. There was insufficient information to determine the reporter's causality assessment.									U	11/20/2002	12/08/2002	18		UNK	UNK	NONE		NONE		PJP200200839	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234108	02/22/2005		90.0			F	08/22/2003	A report was received from a vaccinees daughter on 09Dec02 regarding a 90 year old female vaccinee who experienced a fingertip size swelling at the injection site 2 days after receiving Fluvirin on 04Dec02. On 06Dec02 the vaccinee experienced a fingertip size swelling at the injection site. The vaccinee had no decrease in arm mobility and no pain was experienced. The event had not resolved at the time of reporting.									U	12/04/2002	12/06/2002	2		UNK	UNK	NONE		NONE		PJP200200840	1						1	Injection site oedema	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234109	02/22/2005		66.0			F	08/22/2003	A report was received from a healthcare professional on 10Dec02, concerning a 66 year old female vaccinee who experienced soreness, redness, and warmth at injection site within one day of receiving Fluvirin on 12Jun02. On the evening of 12Jun02 the vaccinee c/o soreness at the injection site. The next morning the site was described as being very red and warm to the touch. At the time of reporting, the symptoms were resolving and the vaccinee had not yet recovered from the event. The reporter has assessed the relationship of the vaccine to the event as possible.									U	06/12/2002	06/12/2002	0		UNK	UNK	Tenoretic 25mg		NONE		PJP200200844	1						1	Feeling hot; Injection site erythema; Injection site pain	FLU3~EVANS VACCINES~E31862GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234111	02/22/2005		1.07	1	.1	F	08/22/2003	A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicated that a 13 month old female was inadvertently administered Fluvirin IM on 21Nov02. Cross reference: PJP200200805, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200863, PJP200200864, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.									U	11/21/2002	11/21/2002	0		UNK	UNK	NONE		NONE		PJP200200848	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234112	02/22/2005		0.76	0	.8	F	08/22/2003	A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicated that a 9 month old female was inadvertently administered Fluvirin IM on 18Nov02. Cross reference: PJP200200848, PJP200200805,  PJP200200850, PJP200200851, PJP200200852,PJP200200853,PJP200200854,PJP200200855,PJP200200856,PJP200200857,PJP200200858,PJP200200859,PJP200200860,PJP200200861,PJP200200862,PJP200200863,PJP200200864,PJP200200866,PJP200200867,PJP200200868,PJP200200869,PJP200200870,PJP200200871,PJP200200872,PJP200200873,PJP200200874,PJP200200875,PJP200200876,PJP200200877.									U	11/18/2002	11/18/2002	0		UNK	UNK	NONE		NONE		PJP200200849	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234113	02/22/2005		2.0	2	.0	M	08/22/2003	A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicated that a 2 year old male vaccinee was inadvertently administered Fluvirin IM on 20Nov02. Cross reference: PJP200200848, PJP200200805,  PJP200200849, PJP200200851, PJP200200852,PJP200200853,PJP200200854,PJP200200855,PJP200200856,PJP200200857,PJP200200858,PJP200200859,PJP200200860,PJP200200861,PJP200200862,PJP200200863,PJP200200864,PJP200200866,PJP200200867,PJP200200868,PJP200200869,PJP200200870,PJP200200871,PJP200200872,PJP200200873,PJP200200874,PJP200200875,PJP200200876,PJP200200877.									U	11/20/2002	11/20/2002	0		UNK	UNK	NONE		NONE		PJP200200850	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234114	02/22/2005		2.0			M	08/22/2003	A report was received from a health care professional on 22Nov02 concerning a group of vaccinees less than 4 years old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporters causality assessment. Update 1 10Dec02: A follow up report was received by a health professional indicating that a 24 month old male vaccinee was inadvertently administered Fluvirin IM on 23Nov02. Cross reference with: PJP200200848, PJP200200849,PJP200200850,PJP200200805,PJP200200852, PJP200200853,PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859,PJP200200860, PJP200200861,PJP200200862, PJP200200863,PJP200200864, PJP200200865,PJP200200866,PJP200200867,PJP200200868,PJP200200869, PJP200200870, PJP200200871,PJP200200872,PJP200200873,PJP200200874,PJP200200875,PJP200200876,PJP200200877.									U	11/13/2002	11/13/2002	0		UNK	UNK	NONE		NONE		PJP200200851	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234115	02/22/2005		0.92			M	08/22/2003	A report was received from a health care professional on 22Nov02 concerning a group of vaccinees less than 4 years old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicating that an 11 and a half month old male was inadvertently administered Fluvirin IM on 12Nov02. Cross reference: PJP200200848,  PJP200200849, PJP200200850, PJP200200851, PJP200200805, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857,PJP200200858,PJP200200859,PJP200200860,PJP200200861,PJP200200862,PJP200200863,PJP200200864,PJP200200866,PJP200200867,PJP200200868,PJP200200869,PJP200200870,PJP200200871,PJP200200872,PJP200200873,PJP200200874,PJP200200875,PJP200200876,PJP200200877.									U	11/12/2002	11/12/2002	0		UNK	UNK	NONE		NONE		PJP200200852	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234116	02/22/2005		4.0			M	08/22/2003	A report was received form a health care professional on 11/22/2002 concerning a group of vaccinees less than 4 years old of unknown demography who inadvertently received Fluvirin from approximately 11/07/2002-onwards. From 11/07/2002 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporters causality assessment. Update1. 12/10/2002: A follow up report was received from a health professional indicating that a 4 year old male vaccinee was inadvertently administered Fluvirin intramuscularly on 11/14/2002. Cross Reference with: PJP-2002-00848, PJP-2002-00849, PJP-2002-00850, PJP-2002-00851, PJP-2002-00852, PJP-2002-00854, PJP-2002-00805, PJP-2002-00855, PJP-2002-00856, PJP-2002-00857, PJP-2002-00858, PJP-2002-00859, PJP-2002-00860, PJP-2002-00861, PJP-2002-00862, PJP-2002-00863, PJP-2002-00864, PJP-2002-00865, PJP-2002-00866, PJP-2002-00867, PJP-2002-00868, PJP-2002-00869, PJP-2002-00870, PJP-2002-00871, PJP-2002-00872, PJP-2002-00873, PJP-2002-00874, PJP-2002-00875, PJP-2002-00876, PJP-2002-00877.									Y	11/14/2002	11/14/2002	0		UNK	UNK					PJP200200853	1						1	Medication error	FLU3~EVANS VACCINES~E05732HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234117	02/22/2005		27.0			F	08/22/2003	A report was received from a health care professional on 11/22/2002, concerning a group of vaccinees less than 4 years old of unknown demography, who inadvertently received Fluvirin from approximately 11/07/2002-onwards. From 11/07/2002, Fluvirin was administered to vaccinees less than 4 years old, There were no reported adverse events. There was insufficient information to determine the reporters causality assessment. Update1. 12/10/2002: A follow up report was received from a health professional indicating that a 27 month old female vaccinee was inadvertently administered Fluvirin intramuscularly on 11/14/2002. Cross Reference with: PJP200200848,PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200805, PJP2002856, PJP20020857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200863, PJP200200864, PJP200200865, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.									Y	11/24/2002	11/24/2002	0		UNK	UNK					PJP200200845	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234118	02/22/2005		1.58			M	08/22/2003	A report was received from a health care professional on 11/22/02, concerning a group of vaccinees less than 4 years old of unknown demography who inadvertently received Fluvirin from approximately 11/07/02 onwards. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/10/02: A follow up report was received from a health care professional indicating that a 19 month old male vaccine was inadvertently administered Fluvirin intramuscularly on 11/20/02. Cross reference with: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200805, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200863, PJP200200864, PJP200200864, PJP200200865, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876 and PJP200200877.									U	11/20/2002				UNK	UNK	Concomitant Drug Not Used		No risk factors reported		PJP200200855	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234119	02/22/2005		2.0			F	08/22/2003	A report was received from a health care professional on 11/22/2002 concerning a group of vaccinees less than 4 years old of unknown demography who inavertently received Fluvirin from approximately 11/07/2002 onwards. From 11/07/2002 Fluvirin was administered to vaccinees less than 4 years old. There were no adverse events. There was insufficient information to determine the reporters causality assessment.  Follow up 1. 12/10/2002: A follow up report was received from a health care professional indicating that a  2 year old female vaccinee was inadvertnetly administered Fluvirin intramuscularly on 11/19/2002. Cross Reference with: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200864, PJP200200865, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.									U	11/19/2002	11/19/2002	0		UNK	UNK					PJP200200856	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234120	02/22/2005		3.0			M	08/22/2003	A report was received from a health care professional on 11/22/2002 concerning a group of vaccinees less than 4 years old of unknown demography who inadvertently received Fluvirin from approximately 11/07/2002 onwards. From 11/07/2002 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporters causality assessment.  Update1. 12/10/2002: A follow up report was received from a health care professional on 12/10/2002 indicating that a 3 year male vaccinee was inadvertently administered Fluvirin intramuscularly on 11/19/2002. the vaccinee experienced no adverse reactions. Cross Reference with; PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200853, PJP200200854, PJP200200855, PJP200300856, PJP200200805, PJP200200806, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200863, PJP200200864, PJP200200865, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200300872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.									Y	11/19/2002	11/19/2002	0		UNK	UNK					PJP200200857	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234121	02/22/2005					F	08/22/2003	A report was received from a health care professional on 11/22/2002 concerning a group of vaccinees less than 4 years old of unknown demography who inadvertently received Fluvirin from approximately 11/07/2002 onwards. From 11/07/2002 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events.  There was insufficient information to determine the reporters causality assessment. Update1 12/10/2002: A follow up report was received from a health care professional on 12/10/2002 indicating that a 09 month old female vaccinee was inadvertently administered Fluvirin intramuscularly on 11/19/2002. The vaccinee experienced no adverse reactions. Cross Reference with: PJP200200848, PJP200200849, PJP200200850, PJP00851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200805, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200863, PJP200200864, PJP200200865, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870									U	11/19/2002	11/19/2002	0		UNK	UNK					PJP200200858	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234122	02/22/2005		1.0			F	08/22/2003	A report was received from a health care professional on 11/22/2002 concerning a group of vaccinees less than 4 years old of unknown demography who inadvertently received Fluvirin from approximately 11/07/2002 onwards. From 11/07/2002 Fluvirin was administered to vaccinees less than 4 years old.. There were no reported adverse events. There was insufficient information to determine the reporters causality assessment.  Update1. 12/10/2002:  A follow up report from a health care professional indicating that a 1 year old female vaccinee was inadvertently administered Fluvirin intramuscularly on 11/18/2002. The vaccinee experienced no adverse reactions. Cross Reference with:PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200805, PJP200200860, PJP200200861, PJP200200862, PJP200200863, PJP200200864, PJP200200865, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP20000875, PJP200200876, PJP200200877.									Y	11/18/2002	11/18/2002	0		UNK	UNK					PJP200200859	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234123	02/22/2005		1.0			F	08/22/2003	A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicated that a 1 year old female was inadvertently administered Fluvirin IM on 18Nov02.  The vaccinee experienced no adverse reaction. Cross reference: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854,PJP200200855, PJP200200856,PJP200200857,PJP200200858, PJP200200859, PJP200200805, PJP200200861, PJP200200862, PJP200200863, PJP200200864, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.									U	11/18/2002	11/18/2002	0		UNK	UNK					PJP200200860	1						1	Medication error	FLU3~EVANS VACCINES~PJP200200860~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234124	02/22/2005					M	08/22/2003	A report was received from ah health care professional on 11/22/2002 concerning a group of vaccinees less than 4 years old of unknown demography who inadvertently received Fluvirin from approximately 11/07/2002 onwards. From 11/07/02002 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporters causality assessment. Update1. 12/10/2002: A follow up report was received from a health care professional on 12/10/2002 indicating that a 9 month old male vaccinees who was inadvertently administered Fluvirin intramuscularly on 11/15/2002. The vaccinees experienced no adverse reactions. Cross Reference with: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200805, PJP200200862, PJP200200863, PJP200200864, PJP200200865, PJP200200866, PJP20020867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP20200873, PJP2000200874, PJP200200875, PJP200200876, PJP200200877.									Y	11/15/2002	11/15/2002	0		UNK	UNK					PJP200200861	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234125	02/22/2005		1.0			M	08/22/2003	A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicated that a 12 month old female was inadvertently administered Fluvirin IM on 15Nov02. The vaccinee experienced no adverse reactions.  Cross reference: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200805, PJP200200863, PJP200200864, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.									U	11/15/2002	11/15/2002	0		UNK	UNK					PJP200200862	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234126	02/22/2005		0.58			M	08/22/2003	A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicated that a 7 month old male vaccinee was inadvertently administered Fluvirin IM on 15Nov02. The vaccinee experienced no adverse reaction. Cross reference: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200805, PJP200200864, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.									U	11/15/2002	11/15/2002	0		UNK	UNK	NONE		NONE		PJP200200863	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234127	02/22/2005		21.0			F	08/22/2003	A report was received from a health care professional on 11/22/02, concerning a group of vaccinees less than 4 years old of unknown demography who inadvertently received Fluvirin from approximately 11/07/02 onwards. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/10/02: A follow up report was received on 12/10/02, indicating that a 21 month old female vaccinee was inadvertently administered Fluvirin intramuscularly on 11/15/02. the vaccinee experienced no adverse reactions. Cross reference: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857,PJP200200858, PJP20020859, PJP200200860, PJP200200861, PJP200200862, PJP200200863, PJP200200805, PJP200200865, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876 andPJP200200877.									U	11/15/2002				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200200864	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234128	02/22/2005		3.5			F	08/22/2003	A report was received from a health care professional on 11/22/02, concerning a group of vaccinees less than 4 years old of unknown demography who inadvertently received Fluvirin from approximately 11/07/02 onwards. There was no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/10/02: A report was received from a health care professional on 12/10/02, indicating that a 3 and a half year old female vaccine was inadvertently administered Fluvirin intramuscularly on 11/12/02. The vaccinee experienced no adverse reaction. Cross reference: PJP20200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP2002862, PJP200200863, PJP200200864, PJP200200805, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.									U	11/12/2002				UNK	UNK	Concomitant Drug Not reported.		No risk factors reported.		PJP200200865	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234129	02/22/2005		1.5			M	08/22/2003	A report was received from a health care professional on 11/22/02, concerning a group of vaccinees less than 4 years old of unknown demography who inadvertently received Fluvirin from approximately 11/07/02 onwards. There was no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/10/02: A follow up was received from a health care professional on 12/10/02 indicating that a 18 month old male vaccinee was inadvertently administered Fluvirin intramuscularly on 11/12/02. The vaccinee experienced no adverse event. Cross reference with: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200863, PJP200200864, PJP200200865, PJP200200805, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP20020876, PJP200200877.									U	11/12/2002				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200200866	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234130	02/22/2005		1.75			M	08/22/2003	A report was received from a health care professional on 11/22/02, concerning a group of vaccinees less than 4 years old of unknown demography who inadvertently received Fluvirin from approximately 11/07/02 onwards. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/10/02: A follow up report was received by a health professional indicating that a 21 month old male vaccinee was inadvertently administered Fluvirin intramuscularly on 11/12/02. Cross reference with: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200863, PJP200200864, PJP200200865, PJP200200866, PJP200200805, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.									U	11/12/2002				UNK	UNK	Concomitant Drug Not Used		No risk factors reported.		PJP200200867	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234131	02/22/2005		2.0			F	08/22/2003	A report was received from a health care professional on 11/22/02, concerning a group of vaccinees less than 4 years old of unknown demography who inadvertently received Fluvirin from approximately 11/07/02 onwards. There were no reported adverse events. No further information reported. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/10/02: A follow up report was received by a health professional indicating that a 2 year old female vaccinee was inadvertently administered Fluvirin intramuscularly on 11/12/02. Cross reference with: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200863, PJP200200864, PJP200200865, PJP200200866, PJP200200867, PJP200200805, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.									U	11/12/2002				UNK	UNK	Concomitant Drug Not Used		Risk factors not reported.		PJP200200868	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234132	02/22/2005		3.5			M	08/22/2003	A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicating that a 3 and half year old male vaccinee was inadvertently administered Fluvirin IM on 14Nov02. The vaccinee experienced no adverse reaction. Cross reference: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200805, PJP200200864, PJP200200866, PJP200200867, PJP200200868, PJP200200805, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.									U	11/14/2002	11/14/2002	0		UNK	UNK	NONE		NONE		PJP200200869	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234133	02/22/2005		1.0			F	08/22/2003	A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicating that a 12 month old female vaccinee was inadvertently administered Fluvirin IM on 15Nov02. The vaccinee experienced no adverse reaction. Cross reference: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200805, PJP200200864, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200805, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.									U	11/15/2002	11/15/2002	0		UNK	UNK					PJP200200870	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234134	02/22/2005		0.92			M	08/22/2003	A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicating that a 11 month old female vaccinee was inadvertently administered Fluvirin IM on 15Nov02. The vaccinee experienced no adverse reaction. Cross reference: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200805, PJP200200864, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200805, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.									U	11/15/2002	11/15/2002	0		UNK	UNK	NONE		NONE		PJP200200871	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234135	02/22/2005		2.0			F	08/22/2003	A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicating that a 30 month old female vaccinee was inadvertently administered Fluvirin IM on 12Nov02. The vaccinee experienced no adverse reaction. Cross reference: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200805, PJP200200864, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200805, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.									U	11/12/2002	11/12/2002	0		UNK	UNK					PJP200200872	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234136	02/22/2005		0.92			M	08/22/2003	A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicating that a 11 month old male vaccinee was inadvertently administered Fluvirin IM on 12Nov02. The vaccinee experienced no adverse reaction. Cross reference: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200805, PJP200200864, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200805, PJP200200874, PJP200200875, PJP200200876, PJP200200877.									Y	11/12/2002	11/12/2002	0		UNK	UNK	NONE		NONE		PJP200200873	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234137	02/22/2005		3.0			F	08/22/2003	A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicating that a 3 year old female vaccinee was inadvertently administered Fluvirin IM on 12Nov02. The vaccinee experienced no adverse reaction. Cross reference: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200805, PJP200200864, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200805, PJP200200875, PJP200200876, PJP200200877.									U	11/12/2002	11/12/2002	0		UNK	UNK	NONE		NONE		PJP200200874	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234138	02/22/2005		1.0			F	08/22/2003	A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicating that 12 month old female vaccinee was inadvertently administered Fluvirin IM on 14Nov02. The vaccinee experienced no adverse reaction. Cross reference: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200805, PJP200200864, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200805, PJP200200876, PJP200200877.									U	11/14/2002	11/14/2002	0		UNK	UNK	NONE		NONE		PJP200200875	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234139	02/22/2005		1.0			M	08/22/2003	A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicating that 12 month old male vaccinee was inadvertently administered Fluvirin IM on 14Nov02. The vaccinee experienced no adverse reaction. Cross reference: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200805, PJP200200864, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200805, PJP200200877.									U	11/14/2002	11/14/2002	0		UNK	UNK	NONE		NONE		PJP200200876	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234140	02/22/2005		2.0			M	08/22/2003	A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicating that 24 month old male vaccinee was inadvertently administered Fluvirin IM on 14Nov02. The vaccinee experienced no adverse reaction. Cross reference: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200805, PJP200200864, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200805.									U	11/14/2002	11/14/2002	0		UNK	UNK	NONE		NONE		PJP200200877	1						1	Medication error	FLU3~EVANS VACCINES~E35732HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234141	02/22/2005		66.0	65		F	08/22/2003	A report received from a health care professional on 12Dec02, concerning a 66 year old female vaccinee who experienced a blister at the injection site and redness 1 day after receiving Fluvirin on 17Oct02. On 18Oct02, the vaccinee experienced a blister at the injection site and redness 1 day after receiving Fluvirin. The vaccinee was treated with betamethasone dipropionate and celecoxib. At the time of reporting the vaccinee had not yet recovered. There was insufficient information to determine the reporter's causality assessment. Update 1, 30Jan03: A report was received from a health care professional indicating that Fluvirin vaccine was received on 18Oct02. The blister at the injection site continued until the end of December 2002. The event was reported as resolved.									U	10/18/2002	10/18/2002	0		UNK	UNK	Synthroid 25mcg, Aceon 4mg				PJP200200878	1						1	Injection site erythema; Injection site vesicles	FLU3~EVANS VACCINES~E30442GA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234142	02/22/2005		54.0			F	08/22/2003	A report received on 25Oct02 concerning a 33 year old vaccinee and approx 15 clinic staff members who were administered a Fluvirin injection in error in Oct02. On an unk date in Oct02, the vaccinee and approx 15 staff members were administered Fluvirin with 1/2 inch needles. The reporter suspected that the staff members may have received the vaccine via a SC and not an IM route. The reporter has assessed the relationship of the vaccines to the event unclassifiable. A report  received from a health care professional on 13Dec02 concerning a 54 year old female vaccine who was administered Fluvirin SC on 08Oct02. On 08Oct02, the vaccinee was inadvertently administered Fluvirin SC. The outcome of the event was unk. Ref: PJP200200657, PJP200200883, PJP2002008884, PJP200200885, PJP200200889, PJP200200890.									U					UNK	UNK	NONE		NONE		PJP200200882	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234143	02/22/2005		50.0			F	08/22/2003	A report received on 25Oct02 concerning a 33 year old vaccinee and approx 15 clinic staff members (demography unk) who were administered a Fluvirin injection by inappropriate route in error in Oct02. On an unk date in Oct02, the vaccinee and approx 15 staff members were administered Fluvirin with 1/2 inch needles. The reporter suspected that the staff members may have received the vaccine via a SC and not an IM route. No adverse events were reported. The reporter has assessed the relationship of the vaccines to the event unclassifiable. Update 1 13Dec02: An update report was received received from a health care professional on 13Dec02 concerning a 50 year old female vaccine who was administered Fluvirin SC on 08Oct02. On 08Oct02, the vaccinee was inadvertently administered Fluvirin SC. The outcome of the event was unk. No further information was provided. Ref: PJP200200657, PJP200200882, PJP200200890, PJP200200884, PJP200200885, PJP200200889.									U	10/08/2002	10/08/2002	0		UNK	UNK	NONE		NONE		PJP200200883	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234144	02/22/2005		49.0			F	08/22/2003	A report received on 25Oct02 concerning a 33 year old vaccinee and approx 15 clinic staff members (demography unk) who were administered a Fluvirin injection by inappropriate route in error in Oct02. On an unk date in Oct02, the vaccinee and approx 15 staff members were administered Fluvirin with 1/2 inch needles. The reporter suspected that the staff members may have received the vaccine via a SC and not an IM route. No adverse events were reported. The reporter has assessed the relationship of the vaccines to the event unclassifiable. Update 1 13Dec02: An update report was received received from a health care professional on 13Dec02 concerning a 49 year old female vaccine who was administered Fluvirin SC on 08Oct02. On 08Oct02, the vaccinee was inadvertently administered Fluvirin SC. The outcome of the event was unk. No further information was provided. Ref: PJP200200657, PJP200200883, PJP200200882, PJP200200885, PJP200200889, PJP200200890.									U	10/08/2002	10/08/2002	0		UNK	UNK	NONE		NONE		PJP200200884	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234145	02/22/2005		50.0			F	08/22/2003	A report received on 25Oct02 concerning a 33 year old vaccinee and approx 15 clinic staff members (demography unk) who were administered a Fluvirin injection by inappropriate route in error in Oct02. On an unk date in Oct02, the vaccinee and approx 15 staff members were administered Fluvirin with 1/2 inch needles. The reporter suspected that the staff members may have received the vaccine via a SC and not an IM route. No adverse events were reported. The reporter did not have further details (name, age, pregnancy, medical/drug history) of other staff members. The reporter has assessed the relationship of the vaccines to the event unclassifiable. Update 1 13Dec02: An update report was received received from a health care professional on 13Dec02 concerning a 49 year old female vaccine who was administered Fluvirin SC on 08Oct02. On 08Oct02, the vaccinee was inadvertently administered Fluvirin SC. The outcome of the event was unk. No further information was provided. Ref: PJP200200657, PJP200200883, PJP200200882, PJP200200885, PJP200200889, PJP200200890.									U	10/08/2002	10/08/2002	0		UNK	UNK	NONE		NONE		PJP200200885	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234146	02/22/2005		40.0			F	08/22/2003	A report received on 25Oct02 concerning a 33 year old vaccinee and approx 15 clinic staff members (demography unk) who were administered a Fluvirin injection by inappropriate route in error in Oct02. On an unk date in Oct02, the vaccinee and approx 15 staff members were administered Fluvirin with 1/2 inch needles. The reporter suspected that the staff members may have received the vaccine via a SC and not an IM route. No adverse events were reported.  The reporter has assessed the relationship of the vaccines to the event unclassifiable. Update 1 13Dec02: An update report was received received from a health care professional on 13Dec02 concerning a 40 year old female vaccine who was administered Fluvirin SC on 08Oct02. On 08Oct02, the vaccinee was inadvertently administered Fluvirin SC. The outcome of the event was unk. Ref: PJP200200657, PJP200200882, PJP200200883, PJP200200884, PJP200200885, PJP200200890.									U	10/08/2002	10/08/2002	0		UNK	UNK	NONE		NONE		PJP200200889	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234147	02/22/2005		38.0			F	08/22/2003	A report received on 25Oct02 concerning a 33 year old vaccinee and approx 15 clinic staff members (demography unk) who were administered a Fluvirin injection by inappropriate route in error in Oct02. On an unk date in Oct02, the vaccinee and approx 15 staff members were administered Fluvirin with 1/2 inch needles. The reporter suspected that the staff members may have received the vaccine via a SC and not an IM route. No adverse events were reported. The reporter has assessed the relationship of the vaccines to the event unclassifiable. Update 1 13Dec02: An update report was received received from a health care professional on 13Dec02 concerning a 38 year old female vaccine who was administered Fluvirin SC on 08Oct02. On 08Oct02, the vaccinee was inadvertently administered Fluvirin SC. The outcome of the event was unk. Ref: PJP200200657, PJP200200882, PJP200200883, PJP200200884, PJP200200885, PJP200200889.									U	10/08/2002	10/08/2002	0		UNK	UNK	NONE		NONE		PJP200200890	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~SC~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234148	02/22/2005		69.0			F	08/22/2003	A report was received from a health care professional on 21Nov02 concerning a 11 vaccinees between the ages of  56 and 84 years who were inadvertently administered 1ml  Fluvirin on an unreported date. On an unreported date a 11 vaccinees were inadvertently administered 1ml Fluvirin.  No adverse events were reported. There was insufficient information to determine the reporters causality assessment. Update 1 31Dec02: A follow up report was received from a health care professional indicated that a 69 year old female vaccine was inadvertently administered  1.0ml Fluvirin on 21Nov02. Cross Ref with: PJP200200806, PJP200200906, PJP200200905, PJP200200904, PJP200200903, PJP200200902, PJP200200901, PJP200200900, PJP200200898, PJP200200907.									U	11/21/2002	11/21/2002	0		UNK	UNK	NONE		NONE		PJP200200899	1						1	Medication error	FLU3~EVANS VACCINES~E37182KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234149	02/22/2005		74.0			M	08/22/2003	A report was received from a health care professional on 11/21/2002 concerning eleven vaccinees between the ages of 56 and 64 years who were inadvertently administered 1ml Fluvirin on an unreported date. On an unreported date eleven vaccinees were inadvertently administered 1ml Fluvirin, No adverse reaction was reported. There was insufficient information to determine the reporters causality assessment. Update1. 12/31/2002: A Follow up report was received from a health care professional indicated that a 74 year old male vaccinee was inadvertently administered 1.0ml Fluvirin on 11/21/2002. Cross Reference with: PJP200200806, PJP200200906, PJP200200905, PJP200200904, PJP200200903, PJP200200902, PJP200200901, PJP200200899, PJP200200898, PJP200200907.									U	11/21/2002	11/21/2002	0		UNK	UNK					PJP200200900	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~E37182KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234150	02/22/2005		81.0			F	08/22/2003	A report was received from  a health care professional on 11/21/2002 concerning eleven vaccinees between the ages of 56-64 years who were inadvertently administered 1ml Fluvirin on an unreported date. On an unreported date eleven vaccinees were inadvertently administered 1ml Fluvirin. No adverse reaction was reported. There was insufficient information to determine the reporters causality assessment. Update1. 12/31/2002: A follow up report was received form a health care professional indicated that a 81 year old female vaccinee was inadvertently administered 1ml Fluvirin on 11/21/2003. Cross Reference with: PJP200200806, PJP200200906, PJP200200905, PJP200200904, PJP200200903, PJP200200902, PJP200200900, PJP200200899, PJP200200898, PJP200200907.									U	11/21/2002	11/21/2002	0		UNK	UNK					PJP200200901	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~E37182KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234151	02/22/2005		84.0			M	08/22/2003	A report was received from a healthcare professional on 11/21/2002 concerning eleven vaccinees between the ages of 56-84 years who inadvertently were administered 1.0ml Fluvirin on an unreported date. On an unreported date eleven vaccinees were inadvertently administered 1.0ml Fluvirin. No adverse reaction was reported. There was insufficient information to determine the reporters causality assessment. Update1. 12/31/2002:  A follow up report was received from a health care professional indicated that a 84 year old male vaccinee was  inadvertently administered 1.0ml Fluvirin on 11/21/2002. Cross Reference with: PJP200200806, PJP200200906, PJP200200905, PJP200200904, PJP200200903, PJP200200901, PJP200200900, PJP200200899, PJP200200898, PJP200200907.									U	11/21/2002	11/21/2002	0		UNK	UNK					PJP200200902	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~E37182KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234152	02/22/2005		64.0			M	08/22/2003	A report was received from a health care professional on 11/21/2002 concerning eleven vaccinees between the ages of 56-84 years who were inadvertently administered 1.0ml Fluvirin on an unreported date. On an unreported date, eleven vaccinees were inadvertently administered 1ml Fluvirin. No adverse reaction was reported. There was insufficient information to determine the reporters causality assessment. Update1. 12/31/2002: A follow up report was received from a health care professional indicated that a 64 year old male vaccinee was inadvertently administered 1.0ml Fluvirin on 11/21/2002. Cross Reference with: PJP200200806, PJP200200906, PJP200200905, PJP200200904, PJP200200902, PJP200200901, PJP200200900, PJP200200899, PJP200200898, PJP200200907.									U	11/21/2002	11/21/2002	0		UNK	UNK					PJP200200903	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~E37182KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234158	02/22/2005	HI	54.0	54		F	02/09/2005	1/28/05 PM: ascending redness left elbow then from fingertips. 2/8/05 Increasing pain down lower back to thoracic spine. 2/8/05 Admitted to hospital; afebrile. MRI brain negative, C-spine x-ray negative, T-spine  x-ray negative, C-reactive protein 0.8.   03/01/05 Hospital Discharge summary for 2/8-2/14/2005. FINAL DX:  Likely Guillain -Barre syndrome; findings significant for Discharge summary states perioral weakness, persisting pain in back, loss of deep tendon reflexes with progressive lower extremity weakness.  Neuro consult done.  She had improvement with IVIG therapy and was discharged home after 5 days' therapy.         Follow up 7/27/05: Per phone call from RN on 7/20/05: Patient no longer has numbness or weakness (her presenting symptoms). She is back at work, full duty, and is no longer receiving physical therapy. Patient apparently was treated with IVIG. Her physician ordered lab tests (immune markers) and according to the patient, one of the immune markers is still low. Her physician will continue to monitor. The patient was experiencing a lot of flu-like symptoms, but has had none for the past 3 to 4 weeks.					Y	7			Y	01/18/2005	01/28/2005	10	Discharge summary states abnormal csf; CSF protein 116(H); CT scan & MRI WNL; MRI C spine with significant changes at levels C4-5, 5-6, and 6-7.  CBC, BMP unremarkable.	PUB	OTH	Prozac; Ambien	NONE	NONE Discharge summary states central canal narrowing, degenerative spine disease, depression.		HI0501	1						1	Back pain; CSF test abnormal; Erythema; Guillain-Barre syndrome; Hypotonia; Influenza like illness	FLU3~SANOFI PASTEUR~U1529DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0234159	02/22/2005	SC	39.0	39		M	02/11/2005	20 minutes after receiving had a hot flash, nausea, ached all up her neck and ear and fingers were tingling and numb. Took Tyl and hot bath, felt better, by next AM was fine.									Y	02/11/2005	02/11/2005	0		OTH	PUB	Birth Control Pills	NONE		Similar reaction in 1998~Td Adsorbed (no brand name)~~0.00~In Patient		1						1	Hot flush; Hypoaesthesia; Myalgia; Nausea; Paraesthesia	FLU3~SANOFI PASTEUR~U1579AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0234161	02/22/2005	TN	49.0	48		M	02/14/2005	States was given 2 injections. States he was told the 1st shot was full of air and was then given an injection with serum. Had HA 1 1/2 days after shot, denies N/V, numbness/tingling.									Y	02/10/2005	02/12/2005	2	T98.3, axilla lymph nodes R, BP 146/96, 9x9cm diameter, no redness/tender to touch, called Dr. Ice and Ibuprofen prn	PUB	UNK		NONE			TN05010	1						1	Headache; Medication error	FLU3~SANOFI PASTEUR~U1560AB~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0234162	02/22/2005	TN	50.0	50		F	02/14/2005	Pt reports she noticed sporadic itching on left arm 4 days post vaccine admin. Today she has 5 small papules (2 2mm wide) confluent on left deltoid. No swelling, redness or pustules noted. Given Benadryl and hydrocortisone cream. Will call if needed.									U	02/10/2005	02/14/2005	4	NONE	PUB	PUB	NONE	NONE	Sulfa drugs caused upset stomach		TN05009	1						1	Pruritus; Rash papular	FLU3~SANOFI PASTEUR~U1560AB~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0234163	02/22/2005	TN		50		F	02/14/2005	Where shot was given red hot, hard, sore to touch, that night or next AM 9x9cm, no SOB, no H/A. Give Rx for Cephalexin 500mg 1 tab PO bid # 20 Medrol dose pack									Y	02/10/2005	02/10/2005	0		PUB	UNK					TN05008	1						1	Feeling hot; Injection site erythema; Injection site mass; Injection site pain	FLU3~SANOFI PASTEUR~U1560AB~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0234164	02/22/2005	TN	43.0	42		F	02/10/2005	11:30AM received flu shot 30-40 min ago, has reaction to skin under skin and pruritic, no SOB. On Advair, Singulair, Maxair, allergy shots, Fosamax, Topramax, BCP, lungs-CTA, BP 130/90 given Benadryl 50mg mm 11:35am, called 3:15 pt felt better, is tired, no SOB.									Y	02/10/2005	02/10/2005	0		PUB	PUB		NONE	Asthma, environmental allergies		TN05007	1						1	Fatigue; Injection site reaction; Pruritus	FLU3~SANOFI PASTEUR~U1560AB~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0234165	02/22/2005	CO	1.39	1	.4	F	02/10/2003	Fever and morbilliform rash									U	01/31/2005	02/08/2005	8	NONE	PUB	PUB	Tylenol	Pyelonephritis	NONE			1						1	Pyrexia; Rash morbilliform	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A008BA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1417AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0224P~3~IM~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0781P~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A74400B~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0234202	02/23/2005		71.0			F	08/22/2003	A report was received from a health care professional on 21Nov02 concerning a 11 vaccinees between the ages of 56 and 84 years who were inadvertently administered 1ml Fluvirin on an unreported date. On an unreported date a 11 vaccinees were inadvertently administered 1ml Fluvirin. No adverse events were reported. There was insufficient information to determine the reporters causality assessment. Update 1 31Dec02: A follow up report was received from a health care professional indicated that a 71 year old female vaccine was inadvertently administered 1.0ml Fluvirin on 21Nov02. Cross Ref with: PJP200200806, PJP200200906, PJP200200905, PJP200200903, PJP200200902, PJP200200901, PJP200200900, PJP200200899, PJP200200898, PJP200200907.									U	11/21/2002	11/21/2002	0		UNK	UNK	NONE		NONE		PJP200200904	1						1	Medication error	FLU3~EVANS VACCINES~E37182KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234203	02/23/2005		65.0			M	08/22/2003	A report was received from a health care professional on 11/21/2002 concerning  eleven vaccinees between the ages os 56-84 years who were inadvertently administered 1ml Fluvirin on an unreported date.  On an unreported date eleven vaccinees were inadvertently administered Fluvirin. No adverse reactions was reported. There was insufficient information to determine the reporters causality assessment.  Update1. 12/31/2002:  A follow up report was received form a health care professional indicated that a 65 year old male vaccinee was inadvertently administered 1.0ml Fluvirin on 11/21/2002. Cross Reference with: PJP200200806, PJP200200906, PJP200200904, PJP2002009003, PJP200200902, PJP200200901, PJP200200900, PJP200200900, PJP200200899, PJP200200894, PJP200200907.									Y	11/21/2002	11/21/2002	0		UNK	UNK					PJP200200905	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~E37182KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234204	02/23/2005		65.0			M	08/22/2003	A report was received from a health care professional on 11/21/2002 concerning eleven vaccinees between the ages of 56-84 years who were inadvertently administered 1ml Fluvirin on and unreported date. On an unreported date eleven vaccinees were inadvertently administered 1ml Fluvirin. No adverse reaction was reported. There was insufficient information to determine the reporters causality assessment. Update1 12/31/2002: A follow up report was received from a health care professional indicated that a 65 year old male vaccinee was inadvertently administered 1.0 ml Fluvirin on 11/23/2002. Cross Reference with: PJP200200906, PJP200200905, PJP200200904, PJP200200903, PJP200200902, PJP200200901, PJP200200900, PJP200200899, PJP200200898, PJP00907.									U					UNK	UNK					PJP200200906	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~E37182KS~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234205	02/23/2005		56.0			F	08/22/2002	A report was received from a health care professional on 11/23/2002 concerning eleven vaccinees between the ages of 56-84 years who were inadvertently administered 1ml Fluvirin on and unreported date. On an unreported date eleven vaccines were inadvertently administered 1ml Fluvirin. No adverse reactions were reported. There was insufficient information to determine the reporteres cuasality assesment. Update1 12/31/2002: A follow up report was received from a health care professioanl indicated that a 56 year old female vaccinee was inadvertently administered 1.0ml  Fluvriin on 11/21/2002. Cross Reference with: PJP200200806, PJP200200906, PJP200200905, PJP200200904, PJP200200903, PJP200200902, PJP200200901, PJP200200900, PJP200200899, PJP200200898.									U					UNK	UNK					PJP200200907	1						1	Medication error; Overdose	FLU3~EVANS VACCINES~E37182KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234206	02/23/2005					U	08/22/2003	A report was received from a health care professional on 01/03/03, concerning a pair of of twins between 1 and 1.5 years old of unknown sex who inadvertently received Fluvirin on an unspecified date. There was insufficient information to determine the reporter's causality assessment.									U					UNK	UNK	Concomitant Drug Not Used.		No risk factors reported.		PJP200300001	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234207	02/23/2005		0.19	0	.2	M	08/22/2003	A report was received from a health care professional on 01/06/03, concerning a 2 month old male vaccinee who was inadvertently administered 0.5ml of Fluvirin on 01/06/03. Patient was given the vaccine intramuscularly in his left vatus lateralis. The vaccinee had no previous exposure to influenza vaccinations. The patient will be monitored closely for adverse reactions. There was insufficient information to determine the reporter's causality assessment. Update (1) 01/21/03: A follow up report was received from a health care professional indicating that no adverse reaction was experienced by the vaccinee. The vaccinee's parent was advisted to watch the vaccinee for any serious reactions.									U	01/06/2003				UNK	UNK			No risk factors reported.		PJP200300005	1						1	Medication error	DTAP~UNKNOWN MANUFACTURER~~UNK~~~DTAP (NO BRAND NAME)~1|FLU3~EVANS VACCINES~E33402HA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1	USA		Influenza
0234208	02/23/2005		8.0	8		M	08/22/2003	A report was received from a health care professional on 01/06/03 concerning an 8 year old male vaccinee who experienced herpetic like lesions on the arm and axillary swollen lymph nodes two days after receiving Fluvirin on 12/31/02. On 01/02/03, the vaccinee experienced circular herpetic like lesions which trailed along the are, swollen axillary lymph nodes and possible impetigo were also noted. The vaccinee did not exhibit fever or any other symptoms since administration of Fluvirin. The vaccinee received oral augmentin for possible impetigo. The herpetic like lesions crusted over and the swollen lymph nodes have resolved. The reporter has assessed the relationship of the vaccine to the event as possible. Update (1) 01/28/03: A follow up report was received from a health care professional indicating that the vaccinee had developed multiple oval, vesicular lesions (1-2cm) on the right arm within 36 hours of vaccination with Fluvirin. There was an impetiginous appearance to the lesions. The reporter indicated that, after two weeks the lesions are 95% resolved and the swollen lymph nodes are decreasing. The reporter has assessed the relationship of the vaccine to the event as unknown.									U	12/31/2002	01/02/2003	2		UNK	UNK	Concomitant Drug Not Reported.		No risk factors reported. The vaccinee has an allergy to codeine.		PJP200300006	1						1	Herpes simplex; Impetigo; Lymphoedema	FLU3~EVANS VACCINES~E34692HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234209	02/23/2005					U	08/22/2003	A report received from a health care professional on 12/02/02, concerning an unknown number of vaccinees aged between 3-4 years of age who were inadvertently administered 0.5ml of Fluvirin. On unknown dates between 10/21/02 and 12/02/02, an unknown number of vaccinees aged between 3-4 years of age were inadvertently administered 0.5ml Fluvirin. The vaccinees were administered Fluvirin once if they had received it before and twice if they had not. No adverse symptoms were reported. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200200824.									U					UNK	UNK	Concomitant Drug Not Reported.		No risk factors reported.		PJP200300007	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234210	02/23/2005		1.25			F	08/22/2003	A report was received from a health care professional on 01/07/03 concerning a 15 month old female vaccinee who was inadvertently administered 0.25ml Fluvirin intramuscularly on 01/07/03. No adverse reaction was noted. There was insufficient information to determine the reporter's causality assessment.									U	01/07/2003				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200300009	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234211	02/23/2005		0.66	0	.7	F	08/22/2003	A report was received from a health professional on 10/16/02, concerning about 20 vaccinees between the ages of 6-35 months who were inadvertently administered Fluvirin in the vastus lateralis between 14-16 October 2002. None of the vaccinees have exhibited any signs or symptoms of an adverse event. The vaccinees will be closely monitored. There was insufficient information to determine the reporters causality assessment. Update (1) 12/27/02: A report received from a health care professional indicated that an 8 month old female vaccinee inadvertently received Fluvirin on 10/15/02. There were no adverse effects noted at the time of the report. See ref: PJP200200575, PJP200300021, PJP200300022, PJP200300023, PJP200300024, PJP200300025, PJP200300026, PJP200300027, PJP200300028, PJP200300029.									U	10/15/2002				UNK	UNK	Concomitant Drug Not Reported.		No risk factors reported.		PJP200300020	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234212	02/23/2005		1.22	1	.2	F	08/22/2003	A report was received from a health professional on 10/16/02, concerning about 20 vaccinees between the age of 6-35 months who were inadvertently administered Fluvirin in the vastus lateralis between 14-16 October 2002. None of the vaccinees have exhibited any signs or symptoms of an adverse event. The vaccinees will be closely monitored. Update (1) 12/27/02: A report received from a health care professional indicated that a 14 month old female vaccinee inadvertently received Fluvirin vaccination on 10/14/02. There were no adverse effects noted at the time of the report. See ref: PJP200200575, PJP200300020, PJP200300022, PJP200300023, PJP200300024, PJP200300025, PJP200300026, PJP200300027, PJP200300028, PJP200300029.									U	10/14/2002				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300021	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234214	02/23/2005		1.3	1	.3	M	08/22/2003	A report was received from a health professional on 10/16/02, concerning about 20 vaccinees between the ages of 6-35 months who were inadvertently administered Fluvirin in the vastus latralis between 14-16 October 2002. None of the vaccinees have exhibited any signs or symptoms of an adverse event. The vaccinees will be closely monitored. There was insufficient information to determine the reporters causality assessment. Update (1) 12/27/02: A report received from a health care professional indicated that a 20 month old male vaccinee inadvertently received Fluvirin vaccination on 10/15/02. There were no adverse effects noted at the time of the report. See ref.: PJP200200575, PJP200300020, PJP200300021, PJP200320023, PJP200300024, PJP200300025, PJP200300026, PJP200300027, PJP200300028, PJP200300029.									U	10/15/2002				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200300022	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234215	02/23/2005		3.0	2	.7	M	08/22/2003	A report was received from a health professional on 10/16/02, concerning about 20 vaccinees between the ages of 6-35 months who were inadvertently administered Fluvirin in the vastus lateralis between 14-16 October 2002. None of the vaccinees have exhibited any signs or symptoms of an adverse event. The vaccinees will be closely monitored. There was insufficient information to determine the reporters causality assessment. Update (1) 12/27/02: A report received from a health care professional indicated that a 2 year old male vaccinee inadvertently received Fluvirin vaccination on 10/16/02. There were no adverse effects noted at the time of the report. See ref: PJP200200575, PJP200300020, PJP200300021, PJP200300022, PJP200300024, PJP200300025, PJP200300026, PJP200300027, PJP200300028, PJP200300029.									U	10/16/2002				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported.		PJP200300023	1						1	Medication error	FLU3~EVANS VACCINES~E35502Ka~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234216	02/23/2005		0.54	0	.5	M	08/22/2003	A report was received from a health professional on 10/16/02, concerning about 20 vaccinees between the ages of 6-35 months who were inadvertently administered Fluvirin in the vastus lateralis between 14-16 October 2002. None of the vaccinees have exhibited any signs or symptoms of an adverse event. The vaccinees will be closely monitored. There was insufficient information to determine the reporters causality assessment. Update (1) 12/27/02: A report received from a health care professional indicated that a 5 month old male vaccinee inadvertently received Fluvirin vaccination on 10/16/02. There were no adverse effects noted at the time of the report. See Ref: PJP200200575, PJP200300020, PJP200300021, PJP200300022, PJP200300023, PJP200300025, PJP200300026, PJP200300027, PJP200300028, PJP200300029.									U	10/16/2002				UNK	UNK	Concomitant Drug Not Reported		No risk factors reported		PJP200300024	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234217	02/23/2005		1.26	1	.3	M	08/22/2003	A report was received from a health professional on 16Oct02, concerning about 20 vaccines between the ages of 6-35 months who were inadvertently administered Fluvirin between 14-16Oct02. Between 14-16Oct02, about 20 vaccinees between the ages of 6-35 months were inadvertently administered 0.25ml of the Fluvirin vaccine in the vastus lateralis. None of the vaccinees have exhibited any signs or symptoms of an adverse event. The vaccinees will be closely monitored. There was insufficient information to determine the reporters causality assessment. Update 1 27Dec02: A report received from a health care professional indicated that a 14 month old male vaccinee inadvertently received Fluvirin vaccination on 16Oct02. There were no adverse effects noted at the time of the report. See ref: PJP200200575, PJP200300020, PJP200300021, PJP200300022, PJP200300023, PJP200300024, PJP200300026, PJP200300027, PJP200300028, PJP200300029.									U	10/16/2002	10/16/2002	0		UNK	UNK	NONE		NONE		PJP200300025	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234218	02/23/2005					F	08/22/2003	A report was received from a health professional on 16Oct02, concerning about 20 vaccines between the ages of 6-35 months who were inadvertently administered Fluvirin between 14-16Oct02. Between 14-16Oct02, about 20 vaccinees between the ages of 6-35 months were inadvertently administered 0.25ml of the Fluvirin vaccine in the vastus lateralis. None of the vaccinees have exhibited any signs or symptoms of an adverse event. The vaccinees will be closely monitored. There was insufficient information to determine the reporters causality assessment. Update 1 27Dec02: A report received from a health care professional indicated that a female vaccinee of unk age inadvertently received Fluvirin vaccination on 15Oct02. There were no adverse effects noted at the time of the report. See ref: PJP200200575, PJP200300020, PJP200300021, PJP200300022, PJP200300023, PJP200300024, PJP200300025, PJP200300027, PJP200300028, PJP200300029.									U	10/15/2002	10/15/2002	0		UNK	UNK	NONE		NONE		PJP200300026	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234219	02/23/2005		1.42	1	.4	M	08/22/2003	A report was received from a health professional on 16Oct02, concerning about 20 vaccines between the ages of 6-35 months who were inadvertently administered Fluvirin between 14-16Oct02. Between 14-16Oct02, about 20 vaccinees between the ages of 6-35 months were inadvertently administered 0.25ml of the Fluvirin vaccine in the vastus lateralis. None of the vaccinees have exhibited any signs or symptoms of an adverse event. The vaccinees will be closely monitored. There was insufficient information to determine the reporters causality assessment. Update 1 27Dec02: A report received from a health care professional indicated that 16 month old male vaccinee inadvertently received Fluvirin vaccination on 15Oct02. There were no adverse effects noted at the time of the report. See ref: PJP200200575, PJP200300020, PJP200300021, PJP200300022, PJP200300023, PJP200300024, PJP200300025, PJP200300026, PJP200300028, PJP200300029.									U	10/15/2002	10/15/2002	0		UNK	UNK	NONE		NONE		PJP200300027	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234220	02/23/2005		1.79	1	.8	M	08/22/2003	A report was received from a health professional on 16Oct02, concerning about 20 vaccines between the ages of 6-35 months who were inadvertently administered Fluvirin between 14-16Oct02. Between 14-16Oct02, about 20 vaccinees between the ages of 6-35 months were inadvertently administered 0.25ml of the Fluvirin vaccine in the vastus lateralis. None of the vaccinees have exhibited any signs or symptoms of an adverse event. The vaccinees will be closely monitored. There was insufficient information to determine the reporters causality assessment. Update 1 27Dec02: A report received from a health care professional indicated that 21 month old male vaccinee inadvertently received Fluvirin vaccination on 15Oct02. There were no adverse effects noted at the time of the report. See ref: PJP200200575, PJP200300020, PJP200300021, PJP200300022, PJP200300023, PJP200300024, PJP200300025, PJP200300026, PJP200300027, PJP200300029.									U	10/15/2002	10/15/2002	0		UNK	UNK	NONE		NONE		PJP200300028	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234221	02/23/2005		1.19	1	.2	F	08/22/2003	A report was received from a health professional on 16Oct02, concerning about 20 vaccines between the ages of 6-35 months who were inadvertently administered Fluvirin between 14-16Oct02. Between 14-16Oct02, about 20 vaccinees between the ages of 6-35 months were inadvertently administered 0.25ml of the Fluvirin vaccine in the vastus lateralis. None of the vaccinees have exhibited any signs or symptoms of an adverse event. The vaccinees will be closely monitored. There was insufficient information to determine the reporters causality assessment. Update 1 27Dec02: A report received from a health care professional indicated that 14 month old female vaccinee inadvertently received Fluvirin vaccination on 15Oct02. There were no adverse effects noted at the time of the report. See ref: PJP200200575, PJP200300020, PJP200300021, PJP200300022, PJP200300023, PJP200300024, PJP200300025, PJP200300026, PJP200300027, PJP200300028.									U	10/15/2002	10/15/2002	0		UNK	UNK	NONE		NONE		PJP200300029	1						1	Medication error	FLU3~EVANS VACCINES~E35502KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234222	02/23/2005		36.0	36		F	08/22/2003	A report was received from a health professional on 09Jan03, concerning a female vaccinee of unk age who was inadvertently administered Fluvirin instead of Tuberculin PPD ID while pregnant on 09Jan03. On 09Jan03 the vaccinee inadvertently received 0.1ml Fluvirin ID instead of Tuberculin PPD when pregnant. The vaccinee did not exhibit any signs or symptoms of an adverse reaction. There was insufficient information to determine the reporters causality assessment. Update 1 07Apr03: A report was received from a health care professional indicating that the 36 year old vaccinee  was 8 weeks and 3 days pregnant at the time of vaccination.									U	01/09/2003	01/09/2003	0		UNK	UNK	Prenatal Vitamins		Pregnant (sex: female)		PJP200300030	1						1	Medication error; Unintended pregnancy	FLU3~EVANS VACCINES~E35742KA~UNK~ID~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234223	02/23/2005		61.0	61		M	08/22/2003	A report was received from a consumer's family member on 24Jan03 indicating that a 61 year old male vaccinee experienced arthritis, arthralgia, night fevers, rash, fatigue, malaise and red patches approx 3 days after receiving Fluvirin on 18Nov02. On approx the 21Nov02 the vaccinee experienced arthritis, arthralgia, night fevers, rash , fatigue, and malaise. The vaccinee developed aching joints which limited his mobility. The vaccinee subsequently developed raised warm red patches around his knees as well as fevers at night and generalized malaise/fatigue. The vaccinee self medicated with ibuprofen and naproxen but the condition worsened over time. The vaccinee saw a physician on 15Jan03. The reporter indicated that the physician stated that the vaccinees experience was not performed and the only abnormalities were an elevated sedimentation rate of 42 (normal:0-20) and a positive anti-nuclear antibody test (1:160). The physician diagnosed the condition as an arthritis flare up and course of prednisone, but symptoms resumed upon discontinuation. At the time of the report the vaccinee was considering consulting a rheumatologist to confirm diagnosis of arthritis. The vaccinee had not recovered at the time of the report.									U	11/18/2002	11/21/2002	3	Anti nuclear antibody, sedimentation 0-20.	UNK	UNK	NONE		NONE		PJP200300042	1						1	Arthralgia; Arthritis; Fatigue; Malaise; Pyrexia; Rash	FLU3~EVANS VACCINES~E35502KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234224	02/23/2005		3.0	2	.9	M	08/22/2003	A report was received from a consumer on 30Jan03 concerning a 3 year old male vaccinee who experienced a sinus infection 21 days and respiratory infection 2 months after inadvertently received Fluvirin on 04Nov02. The vaccinee also experienced a rash after receiving amoxicillin on 17Dec02. On 25Nov02 the vaccinee experienced a sinus infection presenting as fever, rhinitis and cough which resolved after treatment with amoxicillin on 23Dec02. The vaccinee developed a rash which was attributed to amoxicillin. On 04Jan03 the vaccinee developed a respiratory infection which presented as rhinitis, cough and a short episode of eye infection which subsequently resolved. The rhinitis and cough have not resolved.									U	11/04/2002	11/25/2002	21		UNK	UNK	Amoxicillin		NONE		PJP200300045	1						1	Cough; Eye disorder; Pyrexia; Rash; Respiratory tract infection; Rhinitis; Sinusitis	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234225	02/23/2005		29.0	29		F	08/22/2003	A report received from a health professional on 30Oct02, concerning approx 10 vaccinees who inadvertently received last years formulation of Fluvirin. From 28Oct02 to 30Oct02, 20-30 staff members were vaccinated with Fluvirin. After finishing the vaccination, a staff member noticed that one of the used vials was last years vaccine (2001-2002). The vial was discarded, thus the batch number is not available. There was insufficient information to determine the reporters causality assessment. Update 1 27Jan03: A report was received from a health care professional concerning a 29 year old female vaccinee who received expired influenza vaccine (brand unspecified) on an unspecified date. The vaccinee was subsequently revaccinated with this years influenza vaccination and experienced no adverse reaction. See Ref: PJP200200635, PJP20030049, PJP200300051, PJP200300052, PJP200300053, PJP200300054.									U	10/28/2002				UNK	UNK	NONE		NONE		PJP200300050	1						1	Medication error	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0234226	02/23/2005		58.0	57		F		A report received from a health professional on 30Oct02, concerning approx 10 vaccinees who inadvertently received last years formulation of Fluvirin. From 28Oct02 to 30Oct02, 20-30 staff members were vaccinated with Fluvirin. After finishing the vaccination, a staff member noticed that one of the used vials was last years vaccine (2001-2002). The vial was discarded, thus the batch number is not available. There was insufficient information to determine the reporters causality assessment. Update 1 27Jan03: A report was received from a health care professional concerning a 57 year old female vaccinee who received expired influenza vaccine (brand unspecified) on an unspecified date. The vaccinee was subsequently revaccinated with this years influenza vaccination and experienced no adverse reaction. See Ref: PJP200200635, PJP20030049, PJP200300050, PJP200300052, PJP200300053, PJP200300054.									U	10/28/2002				UNK	UNK	NONE		NONE		PJP200300051	1						1	Medication error	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0234227	02/23/2005		65.0	64		F	08/22/2003	A report received from a health professional on 30Oct02, concerning approx 10 vaccinees who inadvertently received last year's formulation of Fluvirin. From 28Oct02 to 30Oct02, 20-30 staff members were vaccinated with Fluvirin. After finishing the vaccination, a staff member noticed that one of the used vials was last years vaccine (2001-2002). The vial was discarded, thus the batch number is not available. There was insufficient information to determine the reporters causality assessment. Update 1 27Jan03: A report was received from a health care professional concerning a 64 year old female vaccinee who received expired influenza vaccine (brand unspecified) on an unspecified date. The vaccinee was subsequently revaccinated with this years influenza vaccination and experienced no adverse reaction. See ref: PJP200200635, PJP200300049, PJP200300050, PJP200300051, PJP200300053, PJP200300054.									U	10/28/2002				UNK	UNK	NONE		NONE		PJP200300052	1						1	Medication error	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0234228	02/23/2005		56.0	55		F	08/22/2003	A report received from a health professional on 30Oct02, concerning approx 10 vaccinees who inadvertently received last year's formulation of Fluvirin. From 28Oct02 to 30Oct02, 20-30 staff members were vaccinated with Fluvirin. After finishing the vaccination, a staff member noticed that one of the used vials was last years vaccine (2001-2002). The vial was discarded, thus the batch number is not available. There was insufficient information to determine the reporters causality assessment. Update 1 27Jan03: A report was received from a health care professional concerning a 55 year old female vaccinee who received expired influenza vaccine (brand unspecified) on an unspecified date. The vaccinee was subsequently revaccinated with this years influenza vaccination and experienced no adverse reaction. See ref: PJP200200635, PJP200300049, PJP200300050, PJP200300051, PJP200300052, PJP200300054.									U	10/28/2002				UNK	UNK	NONE		NONE		PJP200300053	1						1	Medication error	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0234229	02/23/2005		50.0	50		F	08/22/2003	A report received from a health professional on 30Oct02, concerning approx 10 vaccinees who inadvertently received last years formulation of Fluvirin. From 28Oct02 to 30Oct02, 20-30 staff members were vaccinated with Fluvirin. After finishing the vaccination, a staff member noticed that one of the used vials was last years vaccine (2001-2002). The vial was discarded, thus the batch number is not available. There was insufficient information to determine the reporters causality assessment. Update 1 27Jan03: A report was received from a health care professional concerning a 50 year old female vaccinee who received expired influenza vaccine (brand unspecified) on an unspecified date. The vaccinee was subsequently revaccinated with this years influenza vaccination and experienced no adverse reaction. See ref: PJP200200635, PJP200300049, PJP200300050, PJP200300051, PJP200200052, PJP200300053.									U	10/28/2002				UNK	UNK	NONE		NONE		PJP200300054	1						1	Medication error	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0234230	02/23/2005					M		A report received from a health professional on 06Feb03, concerning an adolescent male of an unspecified age who developed flu with fever, body aches and pain and unspecified length of time after receiving Fluvirin on an unspecified date between Nov and Dec 2002. On an unspecified date the vaccinee developed the flu with fever, body aches and pain. A nasal swab on an unspecified date in Feb03 was positive for Type A and Type B antigens. There was insufficient information to determine the reporters causality assessment.  Cross ref with: PJP200300060; PJP200300061, PJP200300062.									U					UNK	UNK	NONE		NONE		PJP200300059	1						1	Influenza; Laboratory test abnormal; Myalgia; Pain; Pyrexia	FLU3~EVANS VACCINES~E35742KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234231	02/23/2005					F	08/22/2003	A report received from a health professional on 06Feb03, concerning a sexagenarian female vaccinee who developed  flu with fever, body aches and pains an unspecified length of time after receiving Fluvirin on an unspecified date between Nov and Dec 2002. On an unspecified date the vaccinee developed the flu with fever, body aches and pain. A nasal swab on an unspecified date in Feb03 was positive for Type A and Type B antigens. There was insufficient information to determine the reporters causality assessment. Cross ref with: PJP200300059; PJP200300061, PJP200300062.									U					UNK	UNK	NONE		NONE		PJP200300060	1						1	Influenza; Myalgia; Pain; Pyrexia	FLU3~EVANS VACCINES~E35742KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234232	02/23/2005		40.0			F	08/22/2003	A report received from a health professional on 06Feb03, concerning a 40 year old female vaccinee who developed flu with fever, body aches and pains an unspecified length of time after receiving Fluvirin on an unspecified date between Nov and Dec 2002. On an unspecified date the vaccinee developed the flu with fever, body aches and pain. A nasal swab on an unspecified date in Feb03 was positive for Type A and Type B antigens. There was insufficient information to determine the reporters causality assessment. Cross ref with: PJP200300059; PJP200300060, PJP200300062.									U					UNK	UNK	NONE		NONE		PJP200300061	1						1	Influenza; Myalgia; Pain; Pyrexia	FLU3~EVANS VACCINES~E35742KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234233	02/23/2005					F	08/22/2003	A report was received from a health care professional on 6Feb03 concerning a female vaccinee between the ages of 30 and 40 years who developed the flu with fever, body aches and pain an unspecified length of time after receiving Fluvirin on an unspecified date between Nov and Dec 2002. On an unspecified date the vaccinee developed the flu with fever, body aches and pain. A nasal swab on an unspecified date in Feb03 was positive for Type A and Type B antigens. The vaccinees condition had improved at the time of the report. There was insufficient information to determine the reporters causality assessment. Cross ref with: PJP200300059, PJP200300060, PJP200300061.									U					UNK	UNK	NONE		NONE		PJP200300062	1						1	Influenza; Laboratory test abnormal; Myalgia; Pain; Pyrexia	FLU3~EVANS VACCINES~E35742KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234234	02/23/2005		54.0	54		F	08/22/2003	A report was received from a health care professional on 24Feb03 concerning a 54 year old female vaccinee who experienced throbbing and warmth at the injection site an unspecified length of time after receiving Fluvirin on an unk date in Oct02. On an unk date in Oct02 the vaccinee experienced throbbing and warmth in her left deltoid shortly after receiving Fluvirin. The area was warm but not red or swollen and the vaccinee had no fever. The vaccinee had a history of fibromyalgia which was under control at the time of vaccination. The vaccinee received the flu vaccination in the past and experienced no adverse event. The throbbing and warmth had not resolved at the time of the report. The reporter has assessed the relationship of the vaccine to the event as unk. Update 1 25Mar03: A follow up report was received from a health care professional which stated that the vaccinee experienced throbbing in the left upper arm the day after she received Fluvirin on 18Oct02. There was no pain at the time of the injection or on the day of the injection. The arm was warm to touch, not swollen or erthemic. It was so painful at night that she needed to wrap arm in an ice wrap and take unspecified pain medication. The reporter diagnosed trigger point pain exacerbation of fibromyalgia secondary to the injection. The vaccinee needed to wrap her arm in an ice wrap at night and take analgesia as it was so painful. An x-ray of the left humerus on 24Feb03 was normal. At the time of the report the vaccinee was receiving physical therapy with positive slow progress and was still having some bad nights.									U	10/18/2002			X-ray: of the left humerus was normal.	UNK	UNK	Vioxx, Hydrochlorothiazide, Triamterine, Extra strength Tylenol		Fibromyalgia, hypertension		PJP200300074	1						1	Feeling hot; Injection site pain; Sleep disorder	FLU3~EVANS VACCINES~E35462HA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234235	02/23/2005					U	08/22/2003	A report was received from a health care professional on 25Oct02 concerning 7 vaccinees who experienced red, burning, hard nodules at the site of the injection, after receiving Fluvirin on 22Oct02. On 22Oct02, seven out of 68 employees who received Fluvirin at a community hospital experienced red, burning, hard nodules at the site of injection within a few hours. The vaccinees were seen in the ER. The vaccine was administered using a TB syringe with a prefixed needle. It was unk if the pt's recovered. The reporter suspects that these adverse effects are probably associated with this particular batch of Fluvirin. The following day, additional employees received Fluvirin from a different batch and no adverse effects were noted.  Update 1 20Feb03: A report was received from a health care professional concerning a vaccinee of unk demography who experienced raised red induration at the injection site 15 min after receiving Fluvirin on an unk date. The vaccinee had recovered at the time of the report. Three other vaccinees had the same reaction to the same batch. There was insufficient information to determine the reporters causality assessment. See Ref: PJP200200541, PJP200300089, PJP200300090.									U					UNK	UNK					PJP200300088	1						1	Injection site erythema; Injection site nodule; Skin burning sensation	FLU3~EVANS VACCINES~E35822KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234236	02/23/2005					U	08/22/2003	A report was received from a health professional on 25Oct02, concerning seven vaccinees who experienced red, burning, hard nodules at the site of injection, after receiving Fluvirin on 22Oct02. On 22Oct02, seven out of 68 employees who received Fluvirin at a community hospital experienced red, burning, hard nodules at the site of injection within a few hours. The vaccinees were seen in the ER. The vaccine was administered using a TB syringe with a prefixed needle. It was unk if the vaccinees recovered. The reporter suspects that these adverse effects are probably associated with this particular batch of Fluvirin. The following day, additional employees received Fluvirin from a different batch and no adverse effects were noted. Update 1 20Feb03: A report was received from health care professional concerning a vaccinee of unk demography who experienced raised red, induration at the injection site 15 min after receiving Fluvirin on an unk date. The vaccinee had recovered at the time of the report. Three other vaccinees had the same reaction to the same batch. There was insufficient information to determine the reporters causality assessment. See Ref: PJP200200541, PJP20030088, PJP200300090.									U					UNK	UNK					PJP200300089	1						1	Injection site erythema; Injection site nodule; Skin burning sensation	FLU3~EVANS VACCINES~E35622KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234237	02/23/2005					U	08/22/2003	A report was received from a health professional on 10/25/2002, concerning seven vaccinees who experienced red, burning, hard nodules at the site of injection after receiving Fluvirin on 10/22/2002. On 10/22/2002, 7 out of 68 employees who received Fluvirin at a Community Hospital experienced red, burnign, hard nodules at the site of injection within a few hours. The vaccinees were seen in the emergency room. The vaccinee was administered using a TS syringe with a prefixed needle. It was unknown if the vaccinees reocvered. The reporter suspects that these adverse effects are probably associated with this particular batch of Fluvirin. The following day, additonal employees received Fluvirin from a different batch and no adverse effects were noted. Update1. 02/20/2003: A report was received from a health care professional concerning a vaccinee of unknown demography who experienced raised, red induration at the injection site 15 minutes after receiving Fluvirn on an unknown date. The vaccinee had recovered at the report. Three other vaccinees had the same reaction  to the same batch. There was insufficient information to determine the reporters causality assessment.  See Reference: PJP2002000541, PJP200300088, PJP200300090.									Y	10/22/2002	10/22/2002	0		UNK	UNK					PJP200300090	1						1	Injection site erythema; Injection site induration; Injection site mass; Injection site swelling	FLU3~EVANS VACCINES~E35822KA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234238	02/23/2005					U	08/22/2003	A report was recieved from a consumer on 02/26/2003, concerning a male vaccinee of unknown demography who received Fluvirin intramuscularly on 02/26/2003. On 02/26/2003, the vaccinee was supposed to receive another vaccine via the intradermal route but was inadvertently given Fluvirin instead. No adverse event had occurred at the time of the report.									U	02/26/2003	02/26/2003	0		UNK	UNK					PJP200300191	1						1	Medication error	FLU3~EVANS VACCINES~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0234242	02/23/2005		51.0			F	08/22/2003	A literature report was received on 24Mar03 concerning a 51 year old female vaccinee who experienced blurred vision, pain and redness associated with a recurrence of iritis in her left eye approx two weeks after vaccination with virus influenza in later Nov94. She had a history of scleritis and recurrent iritis in both eyes for 25 years. No underlying etiology was established for the inflammation and the last recurrence had been documented in 1990. The vaccinee was part of a retrospective study to investigate the possibility that influenza vaccination is a cause of recurrent uveitis in pt's with a history of pre-existing ocular inflammatory disease. In Dec 1994, the vaccinee presented with blurred vision, pain and redness associated with a recurrence of iritis in the left eye. Visual acuity was reduced to 6/7.5 (20/25). There was a mild ciliary flush in the left eye, fine keratic precipitates were scattered on the corneal endothelium and the anterior chamber showed 2+cells and a trace flare. There was no sign of recurrent scleritis.  Intraocular pressure was 15mm Hg by applanation. Fundus examination was unremarkable. The vaccinee was treated with topical dexamethasone 0.1% drops four times daily, topical atropine sulfate 1% twice daily, and systemic corticosteroids for seven days. The vaccinee fully recovered after 14 days. The authors concluded that influenza vaccination may act as a nonspecific stimulus of the immune system and thereby, reactivate uveitis. The exposure to influenza vaccine triggered a recurrence of ocular inflammation. Update 1, 06May03: A follow up report was received from a health care professional indicating that the vaccinee had recovered without sequelae. Cross ref with: PJP200300141, PJP200300142, PJP200300143.									U				Fundus examination, Intraocular pressure, Visual acuity	UNK	UNK	NONE		No previous adverse events from vaccinations. Scleritis in both eyes for 25 years.		PJP200300146	1						1	Ciliary muscle spasm; Flushing; Iritis; Ocular hyperaemia; Pain; Vision blurred	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0234247	02/23/2005	NY	1.97	1	1	M	02/17/2005	Hives lower right arm.  Benadryl 4 times a day.				Y					U	02/16/2005	02/16/2005	0		PVT	UNK		URI	No known drug allergies, no prior medical conditions.			1						1	Urticaria	DTAP~SANOFI PASTEUR~C1996AA~4~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~41553AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE426AA~4~IM~RA~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A83578F~4~IM~RA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0234248	02/23/2005	MI	14.0	13		F	02/16/2005	Received immunization at 1PM 02/15/2005.  Went directly to dentist for treatment of tooth infection.  Took ibuprofen on 02/15/2005. Nausea began around 9AM on 02/16/2005 at school, left school.  Swelling of lip began approximately 45 minutes later.  Has appointment with clinic at 1PM 02/16/2005 for treatment  Also had taken 500mg AMP on 02/16/2005.				Y					N	02/15/2005	02/16/2005	1	NONE	PUB	PUB	Ampicillin 500mg	tooth infection	uverted 2 kit gene			1						1	Nausea; Swelling face	FLU3~SANOFI PASTEUR~U1439AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~5514A2~3~IM~LA~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0234249	02/23/2005	UT	3.0	2	.6	M	02/10/2005	Rash on trunk.									Y	01/21/2005	02/09/2005	19		PUB	PUB		NONE				1						1	Rash	FLU3~SANOFI PASTEUR~U1473AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0292P~UNK~IM~LA~HEP A (VAQTA)~1|PNC~PFIZER\WYETH~A57562C~4~IM~LA~PNEUMO (PREVNAR)~1	USA		Influenza
0234250	02/23/2005	AZ	4.0	4		F	02/07/2000	Right arm deltoid, 9x8cm red/warm area.									U	01/31/2005	02/01/2005	1		PVT	PUB		NONE				1						1	Erythema; Feeling hot	DTAP~SANOFI PASTEUR~C169AA~5~~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1555A~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1199~4~~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0347P~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0234291	02/25/2005	ND	41.0	40		M	02/07/2005	Neck pain right side.  Ear pain right side.  Numbness on half of tongue.				Y					U	02/03/2005	02/04/2005	1		MIL	UNK	N/A	NONE	NONE			1						1	Ear pain; Hypoaesthesia; Neck pain	FLUN3~MEDIMMUNE VACCINES, INC.~500354P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0234292	02/25/2005	SC	68.0	68		F	02/24/2005	Pt presented with SIADH and muscle weakness and was coincidentally diagnosed with Guillain Barre. She was treated with PO demeclocycline and IVIG and physical therapy.  04/20/05 Involved case final diagnosis of GBS, with URI Hx prior to flu vax, with onset of S/S 10 days' post flu vax. Pt presented w inability to stand, walk, myalgia and some worsening of low back pain. On exam strength noted to be 5/5 in all extremities but w absent DTR's in lower extremities. Pt's labs were consistent w SIADH and initial intervention focused on correcting the electrolytes. The following day, the chemistries became increasingly altered and mental status changes of hallucinations and disorganized speech. Work-up at that point included CT's of chest and head (which had unsure clinical significance or negative), LP with Protein level 159 and EMG which showed slowing of nerve conduction in lower extremities and changes in both motor and sensory nerves of upper extremities.  Pt in MICU due to Hyponatremia  & MRI of head at this time showed tiny scattered areas of deep white matter with a high C2 signal(of doubtful significance).  Questional Dx of viral meningitis and lupus cerebritis was ROed and after being transfered back to floor, pt given 4 rounds of IVIG, pt's mental status cleared dramatically, her sodium level trended upward with increased dose of Demeclocycline. She did have increase in BP, controlled w metoprolol; With these changes, pt transfered to rehab.					Y	12		Y	Y	02/03/2005	02/13/2005	10	Information from  discharge summary states abnormal CT of chest, leukocytosis, ketosis, hyperkalemia, hyponatremia, CSF protein 159(H), EMG/NCS abnormal, MRI brain abnormal.	PVT	PVT	Percocet; Trileptal; Valium; Tamiflu	Just got over 2 wk cold Information from discharge summary states pharyngitis	Neuropathic Pain; Back Pain; HTN; Anxiety Information from Discharge summary states cough, tobacco dependence, trigeminal neuralgia; medical records  state cardiac arrhythmia; degenerative disc disease; no adverse reaction to previous flu shots.			1						1	CSF test abnormal; Gait disturbance; Guillain-Barre syndrome; Headache; Hyperkalaemia; Hypertension; Hyponatraemia; Inappropriate antidiuretic hormone secretion; Ketosis; Laboratory test abnormal; Leukocytosis; Muscular weakness; Myalgia; Pain; Thinking abnormal	FLU3~SANOFI PASTEUR~U1455DA~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0234301	02/25/2005	CT	18.0	18		F	02/23/2005	Fluzone administered 11:40 AM 02/23/2005.  From 2:00 to 6:30PM same day, complained of subjective throat tightness, dyspnea and itching.  Objective findings minimal.  No apparent distress, no stridor, lungs clear to ascultation with wheeze.  Developed 2-3 macular, itchy erythematous patches.  Treated with Benadryl  and observed for 2 hours.				Y					Y	02/23/2005	02/23/2005	0	N/A	UNK	UNK	Ortho tricyclen Lo Amoxicillin Keflex	No	Asthma			1						1	Dyspnoea; Erythema; Pruritus; Throat tightness	FLU3~SANOFI PASTEUR~U1529DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0234302	02/25/2005	PA	40.0	40		F	02/09/2005	Symptoms:  4cm of erythema, 1cm of induration.  Treatment:  None; recovery 4 days.				Y					Y	01/03/2005	01/05/2005	2	N/A	PUB	PVT	N/A	N/A	N/A			1						1	Erythema	FLU3~SANOFI PASTEUR~U1442AA~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0234303	02/25/2005	PA	32.0	32		M	02/09/2005	4 x 2 1/2 inch area of erythema left upper extremity, burning, itch.  Weakness of grip due to pain.  Treatment:  Prednisone burst, Motrin as needed; recovery 2 days after start of prednisone.				Y					Y	01/03/2005	01/05/2005	2	N/A	PUB	PVT	N/A	N/A	N/A			1						1	Erythema; Pain; Pruritus; Skin burning sensation	FLU3~SANOFI PASTEUR~U1442AA~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0234323	02/25/2005	TX	49.0	48		F		This is a non-serious spontaneous case from a consumer in  the USA involving difficulty breathing, the reporter causality is possibly related to FluMist. This case is submitted according to the VAERS Safety Surveillance accelerated reporting agreement for FluMist. A 48 year old female received FluMist on 10/19/2004. Approximately 4 hours later, the patient developed blisters in and around nose area and ear congestion, more on the right than the left. One to 2 weeks later, she experienced difficulty breathing which required two doctor visits where she received aerosol treatments. The patient also claimed she experienced depression at the time as well as had suicidal thoughts because she felt that she wasn't getting better. She had a history of Chronic Fatigue Syndrome, fibromyalgia, herpes simplex, and depression. The patient stated she has recovered from these reactions  except for the constant ear congestion.									N	10/19/2004	10/19/2004	0		PVT	PVT	Paxil, Wellbutrin, Seroquel, Xanax		Chronic Fatigue Syndrome, Depression, Herpes Simplex, fibromyalgia		MEDI0001757	1						1	Blister; Depression; Depression suicidal; Dyspnoea; Fibromyalgia; Herpes simplex; Nasal congestion; Sleep disorder	FLUN3~MEDIMMUNE VACCINES, INC.~IN500334P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0234329	02/25/2005	NJ	9.0	9		F		This is a serious spontaneous case from a physician in the USA involving asthma. The reporter causality is not related to FluMist. This case is submitted according to the VAERS accelerated reporting agreement for FluMist. This is a spontaneous case report sent by a physician that refers to a female aged 10 years. The patient's past medical history included pneumonia in October 2003 and in the year 2002. She received FluMist on 12/10/03, the lot number and vaccine administrator were not recorded. On 1/19/04, the patient experienced fever, persistent cough, and shortness of breath. She was brought to the emergency department where she was reported to have decreased oxygen saturation. She was admitted to the hospital with a diagnosis of right lower lobe pneumonia confirmed by chest x-ray and asthma. Structural abnormality/reactive airway disease, and cystic fibrosis were ruled out. Triple IV antibiotics were administered and was placed on oxygen supplement via face mask for several days. During this hospitalization, the patient had episodes of oxygen saturation below 90% while sleeping. The patient has not been diagnosed with asthma before this event. The reporter felt neither pneumonia or asthma were related to FluMist, although he did consider the possibility. The patient has recovered but continues on a daily steroid inhaler and salbutamol as needed.			Y		Y	7			Y	12/10/2003	01/19/2004	40	Chest x-ray: right lower lobe pneumonia	PVT	PVT	NONE		Pneumonia in 2003 and 2002.		MEDI0002893	1						1	Asthma; Cough; Dyspnoea; Hypoxia; Lobar pneumonia; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500034P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Life Threatening,Hospitalisation	Influenza
0234349	02/25/2005	CA	4.0	4		M	02/25/2005	Fluzone administered on 18 February child stated it hurt right after it was given.  Came into clinic on 20 February.  Arm was markedly edematous and swollen from shoulder to elbow.  Free range of motion of shoulder, elbow, and wrist.  The area was NOT WARM.									Y	02/18/2005	02/20/2005	2	None	MIL	MIL	None	None	None			1						1	Injection site pain; Injection site swelling; Oedema peripheral	FLU3~SANOFI PASTEUR~U1555AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0234354	02/25/2005	NE	35.0	34		M	02/25/2005	Parathesis, brain lesions, possible multiple sclerosis. Symtoms still ongoing. Treatment catscan, MRI, and spinal tap. Information from medical records states decreased strength. msv				Y					U	12/13/2004	12/24/2004	11	Catscan, MRI, spinal tap Information from Medical records state abnormal lab results. msv	UNK	UNK	N/A	N/A	Medical records state keratotomy. msv Medical records state neck injury. msv	Flu Symptoms~Influenza (Seasonal) (no brand name)~1~0.00~In Patient		1						1	Asthenia; Laboratory test abnormal; Multiple sclerosis; Nuclear magnetic resonance imaging brain abnormal; Paraesthesia	FLU3~SANOFI PASTEUR~U1461DA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0234359	02/25/2005	PR	68.0	68		F	02/11/2005	Edema									U	02/07/2005	02/09/2005	2	NONE	OTH	PVT					PR0501	1						1	Oedema	FLU3~SANOFI PASTEUR~V1521AB~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0605P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0234360	02/25/2005	NC	60.0	60		F	02/04/2005	Angioedema to mid forearm with local pain and induration, that began 24 hours after vaccine administered on 02/02/05.				Y					Y	02/02/2005	02/03/2005	1	NONE	PVT	PVT	Zocor, Diovan , Norvasc, Sotalol, Protonix, Inhaler.	NONE	TMP/SMZ & PCN (n/v)			1						1	Angioneurotic oedema; Injection site induration; Injection site pain	FLU3~SANOFI PASTEUR~U1500AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0531P~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0234380	02/25/2005	TX	19.0	18		F	02/25/2005	Symptoms are facial nerve involvement, weakness and severe weakness in extermities. Information from Medical records states multiple sclerosis. msv				Y					U	02/09/2005			Information fromMedical records states abnormal csf tests. msv	OTH	PVT						1						1	Asthenia; CSF test abnormal; Multiple sclerosis; Muscular weakness; Neuropathy	FLU3~SANOFI PASTEUR~U1449AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0234356	02/26/2005	ID	17.0	17		M	02/26/2005	Repeated pneumonia, multiple bronchitis, and mono-nucleosis, gastro-intestinal distress, fevers, chills, hospitalization. Life long: yearly pneumonias resistant to inoculation, annual and bi-annual bronchitis, symptoms of COPD and chronic breathing problems not associated with asthma.  Chronic fatique.  Cardio-Vascular degeneration, high blood pressure, and events and tendancy toward vascular dissection.			Y	Y	Y		Y	Y	N	01/01/1970	01/01/1970	0	See medical records and C file.	MIL	MIL		High fever, sweats, stomach nausea, extreme fatigue	none related			1						1	Angiopathy; Bronchitis; Chills; Dyspnoea; Gastrointestinal disorder; Hypertension; Lung disorder; Pneumonia; Pyrexia; Viral infection	BCG~UNKNOWN MANUFACTURER~~UNK~~~BCG (NO BRAND NAME)~1|CHOL~UNKNOWN MANUFACTURER~~UNK~~~CHOLERA (NO BRAND NAME)~1|DTPIHI~UNKNOWN MANUFACTURER~~UNK~~~DT+IPV+HIB+HEPB (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|OPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, ORAL (NO BRAND NAME)~1|PLAGUE~GREER LABORATORIES, INC.~~UNK~~~PLAGUE (USP)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0234388	02/28/2005	NY	1.14	1	.1	F	02/28/2005	Macular generalized rash									Y	02/22/2005	02/28/2005	6	none	UNK	UNK						1						1	Rash macular	FLU3~SANOFI PASTEUR~U1427AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0234391	02/28/2005	MN	1.24	1	.2	F	02/28/2005	Pt. developed a post MMR rash.									Y	02/03/2005	02/15/2005	12		UNK	UNK						1						1	Rash	DTAP~GLAXOSMITHKLINE BIOLOGICALS~639a2~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~u1425aa~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0432N~4~IM~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0419P~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0447P~2~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0234405	02/28/2005	CA	8.0	7		M	02/28/2005	7 year old with onset of gastroenteritis symptoms 2/13/05. Subsequently had positive brain scan determined to be cerebral infarction.			Y		Y	6			Y	01/28/2005	02/13/2005	16	Cerebral/Vascular accident; Abnormal brain scan: mass effect left posterior fossa. Information from Medical records states abnormal lab tests. msv	PVT	PVT		Attention deficit disorder	Attention deficit disorder Information from medical records states enlarged adnoids, sinus disease. msv			1						1	Cerebral infarction; Cerebrovascular accident; Gastroenteritis; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U1594AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0234415	02/28/2005	MS	51.0	50		F	02/24/2005	Vaccine given at 9:30 AM by 5 PM left arm hard, sore and swollen but no redness. This AM arm much more swollen. Left arm 36cm in circumference and right arm 33cm in circumference. 9'x6' reddened hard area shoulder to elbow.									U	02/23/2005	02/23/2005	0		PUB	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1561AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0686N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0234416	02/28/2005	MA	69.0	69		M	02/22/2005	Influenza vaccine given on 12/10/04. 1/24/05: URI symptoms. 1/25: shoveled snow. 1/26: Nausea, vomiting, weakness. 1/27: Lost movement and feeling in lower half of body. Per follow up report received 05/06/2005:  Patient still has paraplegia and bladder control symptoms.					Y	10		Y	N	12/10/2004	01/27/2005	48	LP: Protein 146, LV 67, Oligoclonal bands, 473 WBC, 53 RBC 98 Polys, MRI demyelination.	PVT	PVT		NONE	Dysthyma			1						1	Asthenia; Demyelination; Hypokinesia; Laboratory test abnormal; Nausea; Paraesthesia; Upper respiratory tract infection; Vomiting; White blood cell disorder	FLU3~SANOFI PASTEUR~U1426AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0234417	02/28/2005	MI	53.0	53		F		Right arm was like a ball of fire, a knot with fingers squeezing constantly. Very Very intense pain. Had physical therapy and massages.									Y	11/01/2001			But now I've been diagnosed with Parkinson disease.	OTH	OTH						1						1	Hypertonia; Pain; Parkinsonism	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0234403	03/01/2005	NY	22.0	22		F	03/01/2005	Patient was undergoing predeployment processing on 07 Feb 05. The Smallpox vaccination was administered following a urine HcG test. On 28 Feb 2005, the patient notified me that she had a positive home pregnancy test.									Y	02/07/2005	02/28/2005	21	Urine HcG prior to Smallpox administration	MIL	MIL	None known	None	None	Pregnancy following Smallpox Administration~Smallpox (Dryvax)~1~0.00~Patient		1						1	Medication error; Unintended pregnancy	FLU3~SANOFI PASTEUR~U1557AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020072~1~ID~LA~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~X0850~2~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0234444	03/01/2005	SC	3.0	3		M	03/01/2005	Right upper arm red and swollen.  Warm to touch without tenderness.  Good movement.  Placed on short course of steroids.				Y					U	02/22/2005	02/22/2005	0	NONE	UNK	UNK	Zyrtec	Contact dermatitis	eczema		SCp0501	1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1579AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0234449	03/01/2005	MO	0.52	0	.5	M	02/22/2005	Temperature of 101 F.									Y	12/30/2004	12/30/2004	0		UNK	UNK		None	None		MO2005009	1						1	Pyrexia	FLU3~SANOFI PASTEUR~U1553AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0234452	03/01/2005	WA	0.53	0	.5	M	03/01/2005	Parent reports after first .25cc dose of influenza vaccine on 1/31/05 patient had unconsolable crying for 12 hours and temperature as high as 101.9 not reduced by Tylenol. Parent called hospital advice RN, was told to place patient in cool/lukewarm bath to decrease temperature, Parent stated it worked, fever broke and crying stopped.									Y	01/31/2005	01/31/2005	0	none	UNK	UNK	NONE	NONE	NONE			1						1	Agitation; Crying; Pyrexia	DTAP~SANOFI PASTEUR~C1696AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1515AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0183P~3~IM~RL~HEP B (RECOMBIVAX HB)~1|HIBV~SANOFI PASTEUR~UE169AA~3~IM~LL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~X0707~3~SC~RL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~495929~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0234461	03/01/2005	NC	33.0	33		F		Client returned with complaint of pain in left side of neck, right shoulder, and lower left side of arm after receiving flu shot 2 hours prior.				Y					U	12/30/2004	12/30/2004	0	N/A	PUB	PUB	NONE	None Noted	None Noted			1						1	Neck pain	FLU3~SANOFI PASTEUR~U1568AH~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0234484	03/02/2005	AL	8.0	8		M	02/18/2005	This is a spontaneous case report sent to a private physician that refers to a male aged 8 years. He received FluMist on 1/17/05 at 1:00 in the afternoon. The patient's concomitant medication included cefdinir. On 1/21/05, the patient presented in the reporters office complaining of left ear pain. He received ciprofloxacin and dexamethasone for treatment of the ear pain. On 1/24/05, the patient developed fever, vomiting, pain in his right leg, right foot, pain in his wrist, and elbow. He complained that he could not walk and could only move his toes. On 1/25/05, he presented in the reporter's office and required hospitalization for group A streptococcal bacteremia, osteomyelitis, and arthritis. He was placed on the general floor and was discharged on 2/11/05. As of 2/22/05, the patient is at home on IV antibiotics, out of school, and using a walker and bed pan. He is recovering slowly. The reporter stated the events were not related to FluMist. 04 Aug 05- Several attemps made to obtain patient's recovery status but unable to. Letter requesting this information was sent to the reporter/ physician.					Y				N	01/17/2005	01/21/2005	4	Strep Blood culture 01/25/05 positive, strep throat culture 01/25/05 negative. Per patient's mother, patient continues to experience mild arthralgias and is currently receiving physical therapy. 26 June 06 Request for more information have been sent, as of 24Aug06, no further information has been recieved from the reporter.	PVT	PVT	Omnicef				MEDI0002909	1						1	Arthralgia; Arthritis; Bacterial infection; Ear pain; Gait disturbance; Osteomyelitis; Pain in extremity; Pyrexia; Sepsis; Streptococcal identification test positive; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500355P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0234498	03/02/2005	TN	58.0	58		F	02/24/2005	Approximately 34.5 hours after receiving vaccination, she experienced muscle cramps in her leg, runny nose, sneezing and sensation that her throat was closing. She said she may have been having a panic attack. She used her nebulizer, took benadryl and a steroid. She had her epi pen by side in case she needed it. The episode lasted 5 minutes.									Y	02/16/2005	02/17/2005	1	NONE	PUB	PUB	Loratadine, Flovent, Famotidine,Allergy pill and Albuterol.	NONE	Lung cancer 5 years ago, allergic to bee's honey and asthma. Carries epi pen.			1						1	Anxiety; Muscle spasms; Rhinorrhoea; Sneezing; Throat tightness	FLU3~SANOFI PASTEUR~U1594AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0234499	03/02/2005	WA	3.0	3		M	02/15/2005	Child received a single vaccine, influenza 0.5 cc at 3:30 p.m. Parent and provider 10 minutes later notice non itchy urticaria, raised clear rash surrounded by erythema on neck and cheeks. Over 10 minutes this faded and progressed to forearms, upper chest and back. No wheezing. All bumps resolved by the time they reached home 15 to 20 minutes later.									Y	02/14/2005	02/14/2005	0	NONE	PUB	PUB	NONE	NONE	NONE		WA052092	1						1	Erythema; Rash; Urticaria	FLU3~SANOFI PASTEUR~U1512AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0234500	03/02/2005	CO	2.0	2	.5	M	02/24/2005	Seizure. Follow up: New onset seizure; evaluated at medical center. Had CT and other work up, seen in office 1/21/05.				Y					Y	01/19/2005	01/20/2005	1	Head CT and EEG	PVT	PVT	N/A	NONE	N/A			1						1	Convulsion	FLU3~SANOFI PASTEUR~U1463AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0234501	03/02/2005	CT	1.26	1	.3	M	02/18/2005	Had erythematous maculo-papular rash that began 3 days after the injections, on both thighs and arms. The rash worsened over the next 17 days and th macules have coalesced into patches. The maculo-papular rash spread to lower extremities and onto the dorsum of both feet.				Y					U	02/03/2005	02/06/2005	3	NONE	PVT	PUB	Given Amoxicillin 300mg TID on 02/03/05	Bilateral Otitis Media				1						1	Erythema; Rash maculo-papular	DTAP~GLAXOSMITHKLINE BIOLOGICALS~639A2~4~~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1465AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A74404A~4~~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0766P~1~~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0234503	03/02/2005	GA	4.0			U	03/02/2005	Child's mother, a pediatrician, received FluMist (LAIV) on the specified date. The child, who did not receive FluMist, became ill with flu like symptoms 15 days later. It was reported that the whole family became ill. An influenza virus (wild type, not vaccine strain) was isolated from the child from a sample taken one day after onset of illness.									Y	10/11/2004	10/26/2004	15	CDC influenza lab analysis revealed that this isolate was a wild type influenza A(H3N2) virus similar to viruses isolates at the same period of time from unvaccinated people and did not contain any gene of the attenuated reassortant used for the LAIV production.	UNK	UNK	Information not reported	Information not reported	Information not reported			1						1	Infection transmission via personal contact; Influenza like illness	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0234544	03/03/2005	TX	60.0	59		F	02/18/2005	On 02/16/05 at 8:00 PM, patient complained of painful right arm, hand and shoulder. She also had neck pain and fever during night. On 02/17/05, she experienced severe swelling to the right upper arm with redness and warmth to the touch. Referred to private physician .									N	02/16/2005	02/16/2005	0		PUB	PUB	Lipitor, Bellergal, Calcium, Evista and vitamins.	NONE	Breast Cancer, Mastectomy 1988, Allergies and MS.		TX05012	1						1	Injection site erythema; Injection site swelling; Injection site warmth; Neck pain; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1552AA~7+~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0604N~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0234545	03/03/2005	CA	1.0	1	.0	M	02/18/2005	02/13/05-fever, 02/15/05-diarrhea, 02/17/05-rash, 02/18/05- symptoms resolving per mother.									Y	02/07/2005	02/13/2005	6		PVT	PVT		NONE	NONE			1						1	Diarrhoea; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U1535AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1035N~1~SC~~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|PNC~PFIZER\WYETH~A65652E~4~IM~~PNEUMO (PREVNAR)~1	USA		Influenza
0234569	03/03/2005	OR	2.0			F	03/02/2005	PCV 7 influenza left arm 2/25/05, HIB right arm 2/25/05. 3/2/05 woke up with red, sore arm, 9x10 cm redness, non tender, no fever.									U					PVT	PUB						1						1	Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U1464AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0495P~4~IM~~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~A744040~4~IM~~PNEUMO (PREVNAR)~1	USA		Influenza
0234571	03/03/2005					F		A report was received from a female vaccinee in the USA on 2/11/05. No details were provided regarding the vaccinee's medical history or concomitant medications. The vaccinee has stated she has no allergies to eggs. In December 2001, the vaccinee received an influenza vaccination. Within 10 days after vaccination, the vaccinee experienced many symptoms including dizziness, ringing of the ears and total imbalance. The vaccinee was referred to a neurologist who diagnosed her symptoms as a severe reaction to the flu vaccination. The vaccinee underwent physical therapy and it was explained that the symptoms might never completely disappear. The symptoms reoccur when the vaccinee is tired. Follow up information will be sought. A follow up report was received from a female vaccinee in the US on 2/23/05. On an unspecified date in December 2001, the vaccinee received Fluvirin (batch # E10801LA). The vaccinee was treated for what was thought to be an inner ear infection because of extreme dizziness, nausea, ringing of the ears and other symptoms. The vaccinee was seen by a neurologist who diagnosed a severe reaction to the flu shot. The vaccinee was extremely limited in her every day activities. The vaccinee's symptoms have not diminished and often re-occur when she is extremely fatigued. Further information is expected.								Y	U	12/01/2001	12/11/2001	10		UNK	UNK	NONE		No allergies to eggs.		CVOX200500020	1						1	Balance disorder; Dizziness; Nausea; Tinnitus	FLU3~EVANS VACCINES~E10801LA~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0234576	03/03/2005	TX	52.0	51		F	03/03/2005	Hives, pain in upper arm, gland under arm where Td administered swollen/hurts, shortness of breath. Took Liquid Benadryl.									N	02/28/2005	03/02/2005	2		OTH	UNK			Chronic allergies			1						1	Dyspnoea; Lymphadenopathy; Pain; Urticaria	FLU3~SANOFI PASTEUR~U1460AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~AVENTIS PASTEUR~U1354AA~UNK~SC~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0234600	03/04/2005	FL	75.0	74		F	03/04/2005	Dry cough, chills, fever, then developed lesions (blister like) in mouth and then on head, then lymph node enlargement in armpit. Has spoken via telephone to MD and he prescribed medications but client did not take. Awaiting appointment with primary physician				Y					Y	01/19/2005	01/29/2005	10		UNK	UNK	Unknown	no	unknown			1						1	Chills; Cough; Lymphadenopathy; Mouth ulceration; Pyrexia	FLU3~SANOFI PASTEUR~U1149AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0234625	03/07/2005	WA	59.0	58		M	02/09/2005	This is a not serious spontaneous case from a consumer in the USA involving nasal congestion (labelled, USA). The reporter causality is not provided. A 58 year old male who received FluMist on 02/07/2005 from a public health center experienced nasal congestion anD muscle ache. A few hours after receiving the vaccine, the patient was informed by the public health center's administrator that he should not have gotten the FluMist because he was over the FDA approved age range. The patient recovered from symptoms on the same day he received the vaccine. According to the health center's administrator, submission of VAERS report for this incident will be initiated by their office as well.									Y	02/07/2005	02/07/2005	0		PUB	PVT	EC ASA		Hypercholerolesterolemia		MEDI0002863	1						1	Medication error; Myalgia; Nasal congestion; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~IN500335P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~5003550~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0234626	03/07/2005	MS	26.0	26		F		This is a non serious case from a health care professional in the USA involving cough (labeled,USA). The reporter causality is not provided. This case is submitted according to the VAERS Safety Surveillance accelerated reporting agreement for FluMist. A 26 year old female received FluMist in 10/2004. On 01/30/2005, the patient experienced cough, myalgia, and fever. She took the Quidel Flu test and was positive for Influenza A and B. The patient has not yet recovered. Follow up - 27Apr05 additional information received from the reporter: Lot number: 500335P and expiration date: 11May05									U	10/01/2004	01/30/2005	121	Quidel Flu Test - positive for Influenza A and B	PUB	OTH	Digoxin, TOPROL XL, ZANTAC, Birth Control		Allergic to Thermasol		MEDI0002825	1						1	Cough; Drug ineffective; Influenza; Myalgia; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500335P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0234627	03/07/2005	MI	24.0	24		F		This is a non serious case from a consumer in the USA involving nasal congestion (labeled,USA). The reporter causality is not provided. An adult female received FluMist on 01/22/2005 and began to experience runny nose on 01/23/2005. On 01/24/2005, she experienced nasal congestion, sneezing and felt tired and irritable. It is unknown if the patient recovered from the reported symptoms. Information from missing data report states: several attempt to contact the reporter has failed and no further information is available.									U	01/22/2005	01/23/2005	1		OTH	OTH	Comcomitant Drug(s) not reported.				MEDI0002817	1						1	Fatigue; Irritability; Nasal congestion; Rhinorrhoea; Sneezing; Irritability; Nasal congestion; Rhinorrhoea; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0234628	03/07/2005	MI	39.0	38		M	01/24/2005	MEDI-0002780 is not a serious spontaneous case from a consumer in the USA of involving muscle ache:(labeled, USA). The reporter causality is not provided to FluMist. Case reference MEDI0002780 is a spontaneous case report sent by a consumer that refers to a male age 38 years. The patient's past medical history included rosacea. He received FluMist on 01/22/2005 at 9:00 in the morning. The patients concomitant medication included multivitamins. When the patient awoke at 5:30 in the morning of 01/023/2005, the patient had difficulty getting out of bed due to muscle ache and pain. By the afternoon the patient had a fever of 103 degrees Fahrenheit, chills, and a runny nose. The patient received acetaminophen for treatment. As of 01/24/2005 the events had not resolved.									N	01/22/2005	01/23/2005	1		MIL	MIL	Multi-Vitamin				MEDI0002780	1						1	Chills; Movement disorder; Myalgia; Pain; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500365~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0234629	03/07/2005	MA		57		F	02/20/2005	Patient developed a permanent soft tissue swelling approximately 15mm diameter round indurated mass at site of injection both 11/19/03 and 10/13/2004. The lesion developed about 3 weeks post injection. Follow up report received 03/16/2005:  Checked with Allergist, no treatment, no sure about vaccine next year.									N	10/13/2004	12/02/2004	50		PVT	PVT						1						1	Injection site induration; Injection site oedema	FLU3~SANOFI PASTEUR~U1411AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0234630	03/07/2005	DE	34.0	33		M	02/02/2005	None reported.				Y					U	02/01/2005	02/01/2005	0		MIL	MIL						1						1	Unevaluable event	FLUN3~MEDIMMUNE VACCINES, INC.~500356P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0234631	03/07/2005	DE	38.0	38		M	02/01/2005	Sinusitis for 2 days. Treated with Entex, Tessalon Perles and Zithromax.				Y					U	01/31/2005	01/31/2005	0		MIL	MIL	Entex, Zithromax, Tessalon Perles					1						1	Sinusitis	FLUN3~MEDIMMUNE VACCINES, INC.~500356P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0234632	03/07/2005	DE	21.0	20		M	02/01/2005	Patient has pharyngitis, treated with Entex and Amoxicillin.				Y					U	01/26/2005	01/27/2005	1		MIL	MIL						1						1	Pharyngitis	FLUN3~MEDIMMUNE VACCINES, INC.~500356P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0234633	03/07/2005	MO	31.0	31		F	03/01/2005	On 02/26/05, patient experienced a stuffy nose, congestion but no fever. Given Tylenol. Symptoms continued and she stayed home from work. Saw physician on 03/01/05, who gave her a script for Pannaz and Robitussin AC (not filled yet).				Y					Y	02/24/2005	02/26/2005	2	NONE	PUB	UNK		NONE	NKA			1						1	Nasal congestion	FLUN3~MEDIMMUNE VACCINES, INC.~500339P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0234634	03/07/2005	VA	1.04	1	.1	F	02/14/2005	At 5:30, noted local redness reaction at injection site. Treated with an ice pack. NP checked lungs they were clear. Redness of skin over right leg and over varicella injection site of left leg. Also redness of arms. Tylenol given, redness subsided and child was afebrile.									Y	02/14/2005	02/14/2005	0		PUB	PUB	Tylenol	NONE	NKDA			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U1466AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0419P~2~~LA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|PNC~PFIZER\WYETH~A671810~2~~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0442P~2~~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0232210	03/08/2005	OR	84.0	84		F	02/28/2005	Approximately 15-25 seconds after administration, patient said she felt sick, then bent over and went unconscious. We laid her on floor, elevated legs while another called 911. She was able to take some breaths when prompted. We attempted CPR. Little to no pulse. Paramedics arrived within approximately 5 minutes. They administered epinephrine several times. At that point, I was no longer in room while EMT's worked.	Y				Y				N	12/30/2004	12/30/2004	0	NONE	PUB	PVT	NONE	NONE	NONE		OR200508	1						2	Anaphylactic reaction; Apnoea; Cardiac arrest; Coma; Hyperglycaemia; Hypokalaemia; Leukocytosis; Liver function test abnormal; Myocardial infarction; Oedema peripheral; Pneumonia; Stupor; Tongue oedema; Ventricular fibrillation; Dyspnoea; Loss of consciousness; Malaise; Pulse absent	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1443AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0234697	03/08/2005	TN	63.0	62		F	03/04/2005	This case was considered non-serious. From follow up information received on 2/28/05 this case was considered serious based upon medical judgement (OMIC). No seriousness criteria was reported. From initial information received on 2/2/05 from the patient regarding an adverse event occurring in the USA, it was reported that this 62 year old female patient received FLUZONE, lot number U1440AA, administered IM in the left arm on 10/4/04. 32 days later, on 11/5/04, the patient experienced decreased platelets. She reported that her platelets have been falling at a rate of 20,000 every two weeks. The patient has not recovered from this event. From additional information received on 2/28/05 from the responsible physician, it was reported that the patient's platelet count on 11/5/04 was 115,000. The patient had completed consolidation chemotherapy in early 2004, following a diagnosis of acute myeloid leukemia in July of 2003. Examination on 11/5/04 was essentially normal and the patient was considered to be in continued remission status. The patient was reevaluated on 12/2/04 to monitor for evidence of relapse and a drop in her platelet count. It was noted at that time that she had felt fine, except for a viral syndrome. She had also developed some herpes stomatitis at that time and was treated with Famvir. Her platelet count was 96,000. On 12/17/04, the patient was seen again by a physician for repeat blood counts and evaluation. It was noted that she had recently had an upper respiratory infection. A physical examination was normal and her platelet count was 78,000. On 1/7/05, the patient was evaluated for a six week history of thrombocytopenia. Examination showed no evidence of bleeding or fever and the patient denied any other complaint at that time. Her platelet count was 57,000. She was seen again four days later, on 1/11/05, for a bone marrow aspiration and biopsy. Her platelet count at that time was 66,000. Her bone marrow study was reviewed and appears to be consistent with no evidence of leukemia. The patient was scheduled for a repeat blood count in four weeks.				Y					N	10/04/2004	11/05/2004	32	Per the patient, her platelet levels are decreasing by 20,000 every two weeks. From additional information received on 2/28/05 from the responsible physician, the following lab data were obtained: 11/5/04: white count 4.2, hematocrit 43, and platelet count 115,000 with 52 segs and 8 lymphs. A peripheral blood smear appeared normal. On 12/2/04: white count 3.8, hematocrit 40.4, and platelet count 96,000 with 44 segs, 52 lymphs, 2 monos and 2 eosinophils. A review of the peripheral blood smear showed no obvious blast cells. On 12/17/04: white count 3.8, hematocrit 41.8, and platelet count was 78,000 with 51 segs, 1 band, 46 lymphs and 2 monos. On 1/7/05: white count 3.7, hematocrit 39.3, and platelet count 57,000. A blood smear review was unremarkable and there were no obvious blast cells at the time. On 1/11/05: white cell count was 3.6, hematocrit 39.4, and platelet count 66,000 with 26 segs, 10 bands, 60 lymphs, 2 eosinophils and 2 basophils. A review of her peripheral blood smear showed no evidence of blasts. A bone marrow study to evaluate thrombocytopenia was performed. The patient also had a slight drop of her granulocytes. Her bone marrow study was reviewed and appears to be consistent with no evidence of leukemia. Her flow cytometry result was negative. The bone marrow aspirate smear and biopsy did show a hypocellular specimen. Cellularity was about 5% and there was evidence of trilineage maturation. There were no atypical immature myeloid precursors documented. The bone marrow study showed no evidence of disease. A peripheral smear was not available for morphologic review. Automated CBC indices showed hematocrit 39%, WBC 3600, platelets 66,000. Differential percent (obviously diluted by peripheral blood) showed pro 1, myelo 5, meta 9, band 23, seg 21, lymph 29, mono 8 plasma cell 1, NRBC 3. Immunophenotype by Flow Cytometry - Multicolor Analysis showed lymphocytes 36, lymphocytes 36, monocytes 7, granulocytes (all forms)43, and NRBC/Debris 11.	UNK	UNK	Thyroid medication; Zoloft; Hyoscyamine		The patient has an allergy to griseofulvin. She has a history of decreased platelets. At the time of vaccination, she had leukemia. From additional information received on 2/28/05 from the responsible physician, it was reported that the patient had a long history of irritable bowel syndrome and acute myeloid leukemia, which was diagnosed in July of 2003. She started induction chemotherapy at that time. She completed consolidation chemotherapy in early 2004 and received initially 5 plus 2 and then TAD consolidation therapy. Her last chemotherapy was completed in 2004. She had normal cytogenetics, but probably pre-existing myelodysplasia. The patient achieved a complete remission of her cancer. She was seen by a physician on 9/24/04 for routine re-evaluation. At that time she had a bit of nausea and gastric irritability. A physical examination was within normal limits. Laboratory data obtained at that time showed a white count of 4.8, hematocrit 40.8, platelet count 150,000 with 41 segs, 50 lymphs, 2 bands, 5 monos, and 2 eosinphiles.		200500310	1						1	Laboratory test abnormal; Respiratory disorder; Stomatitis; Thrombocytopenia; Viral infection	FLU3~SANOFI PASTEUR~U1440AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0234713	03/08/2005	UT	18.0	18		F		This is a non serious case from a physician in the USA of Urticaria:(labeled, USA). The reporter causality is possible for FluMist. This case is submitted according to the VAERS safety surveillance accelerated  reporting agreement for FluMIst. This is a spontaneous case report sent by a physician that refers to a female aged 19 years. She received FluMist on 02/10/2005. The patients concomitant medication included drospirenone. Sometime on 02/15/2005 the patient developed a urticarial rash. On 02/20/2005 she developed pain when walking and pain in many joints especially her knee. She presented in the reporters office on 24Feb05 for an initial consultataion and was diagnosed with reactive arthritis. She received toradol for treatment and ultracet for pain. The reporter stated he was not sure of the events were due to FluMist. Attempts to locate the vaccine facility and lot number have been unsuccessful. The reporter state that the patient was lost to follow up. No further information is available. 23Apr05 Additional information received from the reporter and incorporated in the narrative: Patient's date of brith, confirmation that the reported vaccine facility was incorrect, and the patient was lost to follow-up,				Y					U	02/10/2005	02/15/2005	5		OTH	OTH	Yasmin	Flu like symptoms	Flu like illness 5 days prior to receiving FluMist.		MEDI0002932	1						1	Arthralgia; Arthritis; Urticaria; Arthralgia; Arthritis; Influenza like illness; Pain; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Emergency room visit	Influenza
0234714	03/08/2005	PA	68.0	68		F	03/08/2005	Diagnosed with Influenza on 03/01/05.									U	10/14/2004	03/01/2005	138	Laboratory results from hospital.	PVT	PVT	long list of meds	NONE	DJD, COPD, HTN, Asthma, Basal Cell CA, CHF			1						1	Drug ineffective; Viral infection	FLU3~SANOFI PASTEUR~U1500AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0234732	03/09/2005		23.0	22		F	10/29/2004	22 year old female with reaction to smallpox including rash,non virulent pustulosis,  10 days after vaccination.									Y	10/18/2004	10/28/2004	10	N/A	MIL	MIL	Prenatal vitamins, Naproxen	NONE	NONE			1						1	Rash pustular	ANTH~EMERGENT BIOSOLUTIONS~FAV082~UNK~~~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~50101N~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020072~1~SC~LA~SMALLPOX (DRYVAX)~1	USA		Influenza
0234733	03/09/2005		20.0	19		M	10/29/2004	19 year old male with non virulent pustulosis 9-10 days after small pox inoculation.									U	10/18/2004	10/29/2004	11	N/A	MIL	MIL	NONE	NONE	NONE			1						1	Rash pustular	ANTH~EMERGENT BIOSOLUTIONS~FAV082~1~~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1457AA~4~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020072~1~~LA~SMALLPOX (DRYVAX)~1	USA		Influenza
0234734	03/09/2005	VA	21.0	21		M	10/29/2004	Multiple erythematous lesions on chest and back. Generalized vaccinia. Treated with claritin.				Y					Y	10/18/2004	10/29/2004	11	N/A	MIL	MIL			NONE			1						1	Cow pox; Rash erythematous	ANTH~EMERGENT BIOSOLUTIONS~FAV082~1~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1457AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~Y020072~1~~LA~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0234735	03/09/2005	VA	65.0	65		F	03/04/2005	Had flu shot 2/1/05. On 02/10/05 in the health department stated shortly after shot had a blister that burst and now draining. Left deltoid had a dime size are with red circumference, inner portion draining yellow whitish pus, which had no odor. Patient also complained of tenderness at site. She was referred to he PMD. Spoke with patient later, PMD diagnosed abscess and treated with Duricef for 10 days. 3/04/05- Patient now recovered.				Y					Y	02/01/2005			Abscess	PUB	PUB	Unknown	NONE	None Known			1						1	Abscess; Injection site abscess; Injection site erythema; Injection site pain; Injection site vesicles	FLU3~SANOFI PASTEUR~U1552AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0234736	03/09/2005	IA	1.06	1	.1	M	02/01/2005	At 11:15 vaccinated, fell asleep and when he woke up 2 hours later, I discovered that both legs were covered in hives which rapidly became one giant hive covering each leg. Instructed by physician to give benadryl every 4-6 hours until symptoms disappeared. Hives were mostly gone by 4 PM. Continued Benadryl through noon the next day, hives reappeared at 5 Pm (01/07/05), receded after Benadryl given and continued until 1/8/05.									U	01/06/2005	01/06/2005	0	RAST egg white, allergy confirmed. After vaccine reaction 01/10/05	PUB	OTH	NONE	NONE	Previously treated for reflux (through 10/04)			1						1	Hypersensitivity; Urticaria	FLUX~UNKNOWN MANUFACTURER~~2~~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~1~IM~RA~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1	USA		Influenza
0234737	03/09/2005	NC	56.0	56		F	03/04/2005	Complaining of deep muscle aching with limited use of arm. ER visit 02/07/05 and Neuro visit 02/09/05.				Y					U	02/04/2005	02/05/2005	1	Chem 7 and CPK Normal Neurology exam- negative	PUB	PUB	Advil and Endocept	Denied	Hypertension, Obesity and Tonsillectomy NKDA			1						1	Hypokinesia; Myalgia	FLU3~SANOFI PASTEUR~U1478AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0234738	03/09/2005	NC	1.28	1	.3	M	02/28/2005	No wheezes, rales, rhonchi or respiratory distress, temperature 99.9, P 140, R 30 at urgent care appoint they day following large urticaria on right buttocks and face that began during the night after immunizations received. Turned to hives generalized, unknown which vaccine responsible for reaction.				Y					Y	02/11/2005	02/11/2005	0	NONE	PUB	PUB	NONE Stated	None Known	None Known			1						1	Urticaria	DTAP~SANOFI PASTEUR~U1316DA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE401AA~4~IM~LL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~1299N~1~SC~LA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|PNC~PFIZER\WYETH~A74399F~1~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0347N~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0234773	03/09/2005	IN	22.0	21		M	02/27/2005	Extreme weakness, fever (104.4F), altered mental status, dehydration. Happened at 1400 and released from hospital after receiving IV fluids and Motrin at 1930. Told to get rest and hydrate and call if any problems.				Y					Y	01/29/2005	01/30/2005	1	Blood cultures, CBC	MIL	MIL	NONE	NONE	NONE			1						1	Asthenia; Dehydration; Pyrexia; Stupor	FLU3~SANOFI PASTEUR~U1505AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0234814	03/10/2005	CA	82.0	81		M	03/10/2005	Patient developed Guillain Barre Syndrome.			Y		Y				Y	10/20/2004	12/10/2004	51	Information from medical records states abnormal lab results. msv	UNK	UNK	Aspirin, Furosemide, Famotidine, Vicodin, Atorvastatin, Lisinopril. Carvedilol	none	allergic to crab meat CAD, Hypertension, Cardiomyopathy, Hyperlipidemia, CHF, Osteoarthritis, s/p Hip replacement, Mitral/aortic  valve disease Information from Medical records states fatigue, injury to hip, renal insuffiency, anemia. msv			1						1	Guillain-Barre syndrome; Laboratory test abnormal	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0234827	03/11/2005	MD	1.59	1	.6	F	03/10/2005	From initial information received on 2/4/05 from a registered nurse regarding an adverse event, it was reported that a 21 month old female patient received a second dose of FLUZONE, lot number U1426AA, administered in the arm on 11/12/04. She had previously received an initial dose of FLUZONE, lot number U1426AA, administered in the arm, as well has her third dose of IPOL, lot number X1038, administered SC in the arm on 10/12/04. On 1/26/05, the patient developed influenza, fever, and cough. A rapid flu test was obtained and was positive. It was reported that the patient recovered from these events. From additional information received on 3/4/05 from a health care professional, it was reported that the patient experienced a febrile seizure. The exact latency was not reported. Based on medical judgement, this case has been upgraded to serious (OMIC). No other information was provided at this time. The reporter of this case is the same reporter as cases 200500322, 200500323, 200500325, 200500326, and 200500327.				Y					U	11/12/2004	01/26/2005	75	Positive rapid flu test.	PVT	PVT			The patient has an allergy to Motrin. She had no significant illnesses at the time of vaccination.		200500324	1						1	Cough; Drug ineffective; Febrile convulsion; Influenza; Laboratory test abnormal; Pyrexia	FLU3~SANOFI PASTEUR~U1426AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0234829	03/11/2005	NE	26.0	26		M		11/9/03 Noticed numbness in feet. 11/11/03 saw MD; progressed rib cage requiring hospitalization, 11/26/03, as he could not walk. 11/26/03 spinal tap confirmed Guillain Barre (GBS). Information from Discharge summary states diarrhea. msv Information from medical records states pain in legs, back, achey, unsteady gait. msv					Y	7			Y	11/05/2003	11/08/2003	3	11/24/03 MRI; 11/26/03 Spinal Tap. From Medical redords lab tests abnormal. msv	OTH	PVT	Serzone	NONE	NONE Information from discharge summary states depression, sting injury; Medical records state tremor, headache. msv			1						1	Abasia; Back pain; Diarrhoea; Gait disturbance; Guillain-Barre syndrome; Hypoaesthesia; Laboratory test abnormal; Pain	FLU3~EVANS VACCINES~765485~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0234830	03/11/2005	FL	60.0	59		F	03/04/2005	Patient complained of aches and sweats x 3 or 4 over past month since flu vaccine.									U	02/02/2005	02/06/2005	4		PUB	UNK	Tylenol, Excedrin					1						1	Hyperhidrosis; Pain	FLU3~SANOFI PASTEUR~PMC05H1529BA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0234831	03/11/2005	SD	35.0	35		F	01/31/2005	Achiness into knees, shoulders and elbows; upper lip swelling, heaviness in tongue; hot and sweaty. Next am - puffy eyelids, lips remained swollen 1/11/2005, complete resouloution of symptoms by Wed AM 01/12/2005/									Y	01/10/2005	01/10/2005	0		PVT	PVT	Toprol prerelief(otc)		Sulfa, Atrial tachycardia, interstitial cystitis.			1						1	Arthralgia; Face oedema; Hyperhidrosis; Pain; Periorbital oedema; Tongue disorder; Tongue oedema	FLU3~SANOFI PASTEUR~Ul425AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1217N~UNK~IM~LA~HEP B (RECOMBIVAX HB)~1	USA		Influenza
0234832	03/11/2005	MN	19.0	18		F	03/05/2005	Pain in right proximal arm/ shoulder-severe fever of 99.9				Y					U	03/05/2005	03/05/2005	0		MIL	MIL			pcn ALLERGY			1						1	Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~U1452AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0234834	03/11/2005	TN	44.0	44		F	01/04/2005	1/2/05 had knot, redness, itching, warm to touch 7AM. 1/3/05 7:00AM itching, red, hot to touch, larger than 1/2/05. 1/4/05 hot to touch, red, itching, knot redness about size of softball.				Y					Y	01/01/2005	01/02/2005	1	NONE	PVT	PVT	PTU, Maxzide, Iron	NONE	NONE			1						1	Erythema; Feeling hot; Oedema; Pruritus; Skin nodule	FLU3~SANOFI PASTEUR~U1561AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0234835	03/11/2005	TN	47.0	46		F	01/05/2005	12/28/04 local swelling and redness at injection site for 2 1/2 days.									Y	12/27/2004	12/28/2004	1	NONE	PVT	PVT	Celexa, Nexium	NONE	NONE			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1561AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0234836	03/11/2005	TN	22.0	22		F	02/03/2005	About 15 minutes after vaccine, I had red blotches on my neck and chest. Symptoms disappeared after 10 minutes. No treatment necessary.									Y	12/20/2004	12/20/2004	0	NONE	PVT	PVT	Yasmin	N/A	N/A			1						1	Erythema; Rash macular	FLU3~SANOFI PASTEUR~U1561AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0234837	03/11/2005	TN	37.0	36		F	02/03/2005	Itching all over for about 2 hours.									Y	12/20/2004	12/20/2004	0	NONE	PVT	PVT		N/A				1						1	Pruritus	FLU3~SANOFI PASTEUR~U1561AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0234838	03/11/2005	CO	5.0	5		F	02/09/2005	Within 3 to 5 minutes after injection, area around site got very red (5x4). Given 12.5mg of Benadryl orally at 16:30.									Y	02/09/2005	02/09/2005	0		PUB	UNK	NONE	NONE	NONE			1						1	Injection site erythema	DTAP~GLAXOSMITHKLINE BIOLOGICALS~622B2~5~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UA1394EA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~SMITHKLINE BEECHAM~VHA844B2~1~IM~RL~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~X07992~4~SC~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0780P~2~SC~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA		Influenza
0234888	03/14/2005	CA	1.22	1	.2	F		Excessive thirst, weight loss, constipation, lethargy during the week flu immunization. Reactions expected to occur. Information from Discharge summary states hyponatremia, acidosis as s/s msv Information from medical records states vomiting, polyuria, decreased appetitie. msv				Y	Y	5			N	10/27/2004	11/10/2004	14	Information from discharge summary states elevated glucose, ketones in UA,  msv	PVT	UNK		Slight cold.	Anemia Information received from discharge summary states poor growth, poor appetite. msv			1						1	Acidosis; Anorexia; Constipation; Diabetes mellitus; Hyperglycaemia; Hyponatraemia; Ketosis; Lethargy; Polyuria; Thirst; Vomiting; Weight decreased	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0234890	03/14/2005	KS	51.0	51		F	03/09/2005	Sudden deafness left ear. Given Prednisone and Valtrex. Little improvement. 60 Day Follow up: deafness left ear veritso. Information from medical records states fatigue, roaring in ears. msv. 12/31/09 Ongoing hearing deficit-Deaf in left ear, partial hearing loss right ear.				Y				Y	N	10/21/2004	10/21/2004	0	Normal work up.	PUB	OTH	Synthroid; Neurontin	NONE	No other acute illnesses. Information from Medical records states headaches, hepititis C, neuropathy. msv			1						1	Deafness; Dizziness; Fatigue; Hypertension; Laboratory test abnormal; Tinnitus	FLU3~SANOFI PASTEUR~U1488AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0234891	03/14/2005	GA	56.0	56		M	03/09/2005	Sore left arm, periodic painful nerves, restricted movement in elevating left arm laterally.  (GBS type symptoms).  Felt pop in tricept muscle during exercise - left arm.									U	10/06/2004	10/29/2004	23		PUB	PVT		None	None			1						1	Hypokinesia; Neuralgia; Pain	FLU3~SANOFI PASTEUR~U1426AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0234892	03/14/2005	TN	77.0	77		F	01/20/2005	Pain in arm where flu vaccine given - pain started just after shot given and has not subsided.  Vaccine give 10/31/2004.  No redness, no edema at site, x-ray and follow up per orthopaedic.  X-ray taken of arm 02/08/2005, x-ray verified no needle object broken off in left deltoid.									U	10/31/2004	10/31/2004	0		PVT	PVT		Arthritis only	allergies: cortisone			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U1516AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0234893	03/14/2005	PA	61.0	61		M	03/08/2005	Within 2 weeks of injection developed shingles on shoulder near site of injection.  Never had shingles before.  Slow healing.				Y					N	02/11/2005	02/18/2005	7		PUB	PVT	None	None	None			1						1	Herpes zoster; Infection	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0234894	03/14/2005	IL	46.0	45		M	03/04/2005	Approximately 3 hours after receiving flu vaccine experienced faint rash over arms and legs, and nausea/vomiting; took Benadryl and Tylenol - cleared by end of day.									Y	11/04/2004	11/04/2004	0	None	OTH	PVT	Zocor	None	Sulfa allergy, elevated cholesterol			1						1	Nausea; Rash; Vomiting	FLU3~SANOFI PASTEUR~U1418AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0234895	03/14/2005	AK	1.02	1	.0	M	02/07/2005	Fever 101-102 at midnight 02/04/2005, treated with Tylenol, no fever 02/05/2005.  Rash on abdomen and trunk, onset 02/07/2005 21:15PM.   No fever.									Y	01/31/2005	02/04/2005	4		PUB	PUB	None	None	None			1						1	Pyrexia; Rash	FLU3~SANOFI PASTEUR~U1416AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1152N~3~IM~RL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0105N~UNK~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0234896	03/14/2005	WI	73.0	72		M	03/08/2005	Complaint of itching sensation on either extremity one week after vaccine.  Scratched areas and developed hives.  Saw doctor on 12/06/2005 and 01/17/2005 for persistent pruritus, generalized.  Treated with Hydroxyzine.									U	11/02/2004	11/09/2004	7	None	PUB	PVT	None	None	None			1						1	Rash pruritic; Urticaria	FLU3~SANOFI PASTEUR~U1504AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0234897	03/14/2005	NY	77.0	76		M	03/08/2005	6 weeks after flu vaccine, profound fever and leg weakness and paresthesia.  Recovered in about 6 more weeks, absent reflexes and ability to recover from stooping all returned. Information from Medical records state pneumonia, cough, sinusitis, chills, nausea, spots in eyes. msv									Y	09/30/2004	11/15/2004	46	None	OTH	OTH	Thiazide, Atenolol, Zestril, Pravachol	Hypertension High Cholesterol	Lumbar laminectomy 12/2003. Information from medical records state allergy and spinal stenosis as pre-existing conditions. msv			1						1	Asthenia; Chills; Cough decreased; Hyporeflexia; Nausea; Paraesthesia; Pneumonia; Pyrexia; Sinusitis; Visual disturbance	FLU3~SANOFI PASTEUR~U1478AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0512P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0234933	03/14/2005	SC	68.0	68		M	03/14/2005	Pt received influenza vaccine in right arm and pneumovax in left arm at clinic.  Documented in chart that pt did not have a reaction after immunizations.  Pt presented to clinic 24 hours later with swollen, painful, warm, erythematous, macular rash on RUE.  Reaction was first noted 1 day after shot in the same area of injection.  Pt was not febrile.  Pt denied allergies to eggs and has had the flu vaccine in the past without complications.  Physician suspected that it was cellulitis and possibly an infection.  Pt was given cephalexin, APAP, and diphenhydramine.  Pt reported 4 days later that the reaction had improved.				Y					Y	11/11/2004	11/12/2004	1		UNK	UNK			Erythromycin and clarithromycin			1						1	Cellulitis; Erythema; Feeling hot; Injection site infection; Pain; Rash macular; Swelling	FLU3~SANOFI PASTEUR~U1560AB~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0529P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0234935	03/14/2005	NY	44.0	43		F	03/14/2005	Approximately 15 minutes after vaccination, patient complained of tightness in her chest and difficulty breathing.  Nurse administered epi-pen 0.3 mg at 9:52 am. On call MD was called.  At 9:55 BP 150/80, pulse 125, RR 32.  At 10:05 BP 130/68, Pulse 100, RR 28.   No wheezing or rales noted.  Repiratory distress resolved post epi-pen.  Patient has a history of receiving flu vaccine in 2003 without incident.  EMS called and transferred patient to hospital.  Patient was evaluated and admitted at hospital with diagnosis of Sickle Cell Crisis and Asthma.					Y	28			Y	10/21/2004	10/21/2004	0		UNK	UNK	Unknown	Unknown	Sicle Cell Anemia Asthma			1						1	Blood pressure increased; Chest discomfort; Condition aggravated; Dyspnoea; Heart rate increased; Hyperventilation; Wheezing	FLU3~SANOFI PASTEUR~U1457AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0235032	03/15/2005	MD	40.0	39		F	03/15/2005	A 39 year old pediatric nurse received FLUMIST vaccine on October 29, 2004. She was been well on the day she got vaccinated but a few days prior she had sore throat and son had a cold.  She developed body aches and low grade fever (described as flu-like) on October 31, 2004 (Day 2 following vaccine).   On Day 3 (11/01/04) she woke up feeling weak. By midday she developed fever, diaphoresis and pleuritic chest pain. She saw her primary care physician who diagnosed pneumonia clinically and placed her on Biaxin(Clarithromycin). The CXR however was negative.   On Days 6 and 7 (11/04/04-11/05/04), while still on Biaxin, she developed a sore throat and anterior lymph node swelling. This was followed by generalized body weakness on Day 9 (11/07/04). She woke up with a headache on Day 10 (11/08/04) which was unresponsive to acetaminophen and became severe by evening. She took 800mg Motrin which gave her no relief. Two hours after taking 2 sleeping pills she woke as a result of the headache. She called her primary care physician who advised her to go the ER, but she did not go.   The next day (Day 11- 11/09/04) she had a temperature of 101F, was sweating and had pain all over. She presented to the ER of an affiliated hospital where she was found to be confused and vomiting and was admitted with a presumptive diagnosis of meningitis/encephalitis after the following lab data became available. A repeat CXR was without significant findings. Lumbar puncture showed: WBC- 480, Neutrophils-25, Monocytes-10, Lymphocytes-65; RBC-5; Protein-97 ; Glucose- 2. She was started on Acyclovir, Vancomycin, and cefuroxime.   We learned that she had a presumptive diagnosis of vaccine associated encephalitis late on the afternoon of 11/11/04 from a friend of hers who works in our office and we obtained permission through the friend to call the patient as we had no physician names. We obtained the primary physician contact information from the patient and information on the infectious disease consulting physician from her admitting doctor after a series of incorrect names given by the ward nurses. He provided us with the following lab data and confirmed that he and the primary physician had told the patient that they believed her illness may have been caused by FLUMIST.  On 11/12/04 we learned that the blood culture was negative as well as the spinal fluid viral culture. CSF HSV culture (PCR?) was negative. Blood was sent for VDRL and Lyme Antibody (results of these tests are pending). We asked about respiratory viral cultures and were told by the infectious disease physician that the culture was done, but checking with the nurses indicated that no respiratory cultures were done. We recommended that the culture be obtained as soon as possible. We obtained permission from the infectious disease consult and patient to retrieve residual CSF (0.5 mL) from the lab, and residual sera from admission (~0.5 mL). We checked the virology lab results via computer and determined the CSF viral culture was negative on 11/12 and 11/19/04. Viral culuture of 11/29/04 was positive for enterovirus. Respiratory viral cultures were never obtained. Her illness resolved quickly and she was discharged after 3 days of hospitalization with a working final diagnosis of post-vaccination meningitis.  Hospital obtained 14,000 doses of Flumist and had administered most of the vaccine as of 12/1/04. No other similar illnesses have been reported. From Discharge summary states abnormal cerebral spinal fluid, viral growth. msv From Medical records photophobia, sore throat, meningismis. msv				Y	Y	3			Y	10/29/2004	10/31/2004	2	WBC count (total and differential), CSF HSV culture, Blood culture, VDRL, Lyme antibody, viral culture	UNK	UNK		None	None From Discharge summary, neurogenic hypotension, chronic leukocytosis, myalgia, arthralgia,  from Medicl records, pregnancy. msv			1						1	Asthenia; CSF test abnormal; Chest pain; Confusional state; Encephalitis; Headache; Hyperhidrosis; Laboratory test abnormal; Lymphadenopathy; Meningism; Meningitis; Pain; Pharyngolaryngeal pain; Photophobia; Pneumonia; Pyrexia; Viral infection; Vomiting; White blood cell count increased	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0235047	03/16/2005	VA	4.0	4		F	03/01/2005	1/7/05 Received flu vaccine. 1/15/05: had cough, non-productive. 1/17/05: had temperature 102, vomiting, decreased appetite. 1/18/05: Seen in ER. 1/19/05: Seen in PCP office; diagnosed virus. 1/20/05: Couldn't walk. Information from discharge summary states deminished reflexes. msv Information from medical records states crackles in lung bases, retractions, rhinitis, headache, otitis, viral infection. msv			Y	Y	Y	8			U	01/07/2005	01/15/2005	8	1/20/05: Admitted to hospital. Tests done: blood cultures, CT of head; MRI of head; lumbar puncture. Diagnosed with Guillain Barre; given IVIG for 3 days.	PVT	OTH	NONE	NONE	NONE			1						1	Abasia; Cough; Decreased appetite; Dyspnoea; Guillain-Barre syndrome; Headache; Hyporeflexia; Otitis media; Pyrexia; Rhinitis; Viral infection; Vomiting	FLU3~SANOFI PASTEUR~U1452AA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0235083	03/16/2005	FL	42.0	42		F	03/16/2005	MODERATE ALLERGIC REACTION WITH RASH AND ITCHING WITHIN ABOUT 10 MINUTES FOLLOWING FLU SHOT, NO RESPIRATORY PROBLEMS. GIVEN 50mg BENEDRYL IM. SENT VIA AMBULANCE TO ER. PT HAS H/O PREVIOUS FLU VACCINATION WITHOUT REACTION. ONLY KNOWN ALLERGY WAS TO SULFA. FOLLOW-UP PHONE CALL LATER IN DAY FOUND PT RECOVERING AT HOME AND PLANNING TO RETURN TO WORK THE NEXT DAY.				Y					Y	02/15/2005	02/15/2005	0	UNKNOWN	UNK	UNK		NONE	ALLERGY TO SULFA			1						1	Hypersensitivity; Pruritus; Rash	FLU3~SANOFI PASTEUR~U1549AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0235084	03/16/2005	MS	74.0	73		F	02/23/2005	11/19/04-Received phone call from patient stating she received a Flu and Pneumonia shot on 11/10/04.  On 11/11/04 she states she had reddness, pain and swelling in right arm and saw a doctor and was treated with SMZ-TMP DS.  On 11/15/04 patient went to her doctor who admitted patient to hospital. Patient was treated for cellulitis with blister 1cm. Patient was treated with IV Unasyn 1.5 grams now and every 6 hours Decadron.				Y	Y	2			Y	11/10/2004	11/11/2004	1	11/15/04- Body fluid culture from blister right arm, no growth in 48 hours.	UNK	UNK	NONE	NONE	NONE		MS05001	1						1	Blister; Cellulitis; Erythema; Laboratory test abnormal; Oedema; Pain	FLU3~SANOFI PASTEUR~U1439AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0685N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0235087	03/16/2005	MT	65.0	65		F	03/16/2005	Injection site reaction in left arm including redness, swelling 13 cm x 3 cm, warm to touch and complains of pain at injection site.  Also complains of chills and fever after receiving vaccinations.									Y	10/26/2004	10/26/2004	0	None.	UNK	UNK	Unknown.	None known.	Unknown.			1						1	Chills; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U1503AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0486P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0214176	03/17/2005	MD	40.0	40		F	03/14/2005	Information has been received from a 40 year old female with asthma, seasonal bronchitis, allergies to sulfisoxazole diolamine, nitrofurantoin, and prochlorperazine maleate, and a history of migraines, who on 12/10/03 was vaccinated with a 0.5ml dose in the right arm of pneumococcal 23v polysaccharide vaccine (lot # not reported). Concomitant vaccination included a dose of influenza virus vaccine (lot # 765885) in the left arm. Subsequently, on 12/10/03, the patient developed soreness at the location of the vaccination followed by a rash and hives on the right side of her body that reappeared once in April 2004, joint pain, and fatigue that she still experiences today. The patient reported that she sought unspecified medical attention and many laboratory tests were performed. The reporter indicated her experiences to be both disabling and life threatening. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow up information received from a health assistant indicated that, on 12/10/03, the patient did not have allergies to eggs, thimerosal, contact lens solution, or mercury. She has never had Guillain Barre syndrome. She did not have a fever or active infection. She did not have an active neurologic condition. She does not have a fever or active infection. She did not take an immunosuppresive therapy or have a condition that affects her immune system. She was not on a steroid medication. She did not have a history of latex sensitivity. She was not pregnant. The patient's body temperature was 97.3. Follow up information from a woman working at a physician's office indicated that, on 12/23/03, the patient was still on hydroxyzine hydrochloride, 25mg, 1 tablet TID for 10 days, 30 tablets, but it was the last day. The patient was on methylprednisolone. It was noted that the patient will be going to an allergist. Today, 12/23/03, was the first day without the antihistamine. Yesterday, on 12/22/03 (also reported as 12/10/03), the patient originally had no hives and got two. Last evening, on 12/22/03, the patient felt as if she had a tight chest. This morning, on 12/23/03, she is coughing and is still tight. The patient now, on 12/23/03, has pain in her hip, knee, and up and down her spine. It was also noted that when one touches her skin it is hypertender. The patient was well appearing, well nourished, and in no distress. She was oriented x3, in normal mood, and affect. Progress notes indicated that the patient had an ongoing reaction to pneumococcal 23v polysaccharide vaccine. She continued hydroxyzine hydrochloride, may try loratadine instead. The patient has had some discomfort during urination. It was noted that a urine culture will be performed. The patient is taking phenazopyridine hydrochloride. Follow up information from a physician indicated that, on 3/1/04, the patient was seen to discuss a pneumococcal 23v polysaccharide vaccine reaction. The patient was still having problems. Her knees, shoulders, elbows, and back were sore. The patient's energy is coming and she is doing more, uncomfortable. Her left arm and anterior chest was sore to the touch. The patient's asthma was controlled, she has not needed an inhaler with cough medicine. The patient felt that the antihistamine is helping with her asthma. She was not using any other antihistamines. Her right knee was swollen some, the left less so. It was noted that stairs bother her. The patient's chest is clear and she had no spinal tenderness. There was some soft tissue swelling above and lateral to her right knee. There was joint line tenderness. The patient could squat without pain. It was reported that the symptoms to the serum sickness reaction to pneumococcal 23v polysaccharide vaccine were slowly improving. The knee pain seemed to be part of the reaction. The option of part time was discussed. It was noted that the physician did not think she had arthritis. The physician also noted that an x-ray would not be useful. A MRI would only show if there was an injury. As there is no history and the symptoms are improving the physician did not see that the test was likely to benefit the patient. It was noted that if a stage was reached where the patient was not improving then it may need to be done. Medication was discussed. The patient liked thecarbinoxamine maleate (+) hydrocodone bitartrate (+) pseudoephedrine hydrochloride, 2tsp, every 4 hours, 8oz. The antihistamine helps with the asthma and other symptoms. Hydrocodone helps with the pain. The possibility of addiction was discussed, but the patient did not think that it was a problem. The carbinoxamine maleate (+) hydrocodone bitratrate (+) pseudoephedrine hydrochloride will continue for now. Additional information has been requested.			Y	Y				Y	U	12/10/2003	12/10/2003	0	Blood pressure 136/1, 140/90; Lyme disease assay negative; Body temp: 97.3, 98.1, 98.5; ESR 2, 8; Serum ANA negative; Serum rheumatoid factor 8.7; Total heartbeat count 98.	OTH	OTH			Migraine; Asthma; Drug hypersensitivity; Allergic bronchitis		WAES0501USA00553	1						2	Arthralgia; Asthenia; Chest discomfort; Chest pain; Cough; Dysuria; Fatigue; Hyperaesthesia; Injection site pain; Laboratory test abnormal; Oedema peripheral; Rash; Serum sickness; Urticaria; Arthralgia; Chest discomfort; Cough; Dysuria; Fatigue; Gait disturbance; Injection site pain; Laboratory test abnormal; Myalgia; Oedema; Rash; Serum sickness; Urticaria	FLU3~EVANS VACCINES~765885~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~2|FLU3~EVANS VACCINES~765885~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~3	USA	Life Threatening,Disabling	Influenza
0235104	03/17/2005	PA	1.0	1	.0	F	03/14/2005	Information has been received from a consumer concerning her 12 month old daughter with otitis media since December 2004 and no known drug allergies who on 2/25/05 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included influenza virus vaccine and gantrisin. On 3/1/05 the patient experienced a seizure and was unresponsive for 20 minutes. Unspecified medical attention was sought and the patient was admitted to the hospital. An RSV test was done and the patient was also diagnosed with RSV. The patient had a CT scan, x-rays, ECG, EEG, blood work and heart monitor for 24 hours (results not reported). At the time of the report, the patient was recovering. There was no product quality complaint involved. Seizure and RSV were considered to be immediately life threatening by the patient's mother. Additional information has been requested.			Y	Y	Y				Y	02/25/2005	03/01/2005	4	3/01/05: x-ray, cardiac monitoring for 24 hrs, computed axial, diagnostic lab, electrocardiogram, electroencephalography, nasopharyngeal RSV: diagnosed with RSV.	OTH	OTH			Otitis Media		WAES0503USA00708	1						1	Coma; Convulsion; Respiratory syncytial virus infection; Viral infection	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~0895P~UNK~~~VARICELLA (VARIVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0235111	03/17/2005	ID	51.0	50		F	02/10/2005	Flu shoot given in left deltoid. complained of pain in rt arm that  evening, then pain spread to both legs and buttocks. She is still havign some pain in back of lower legs, today 02/04/2005does not wish to see her doctor but does want this reported.									N	02/04/2005	02/04/2005	0		PVT	PUB					ID05010	1						1	Arthralgia; Back pain; Injection site pain; Pain	FLU3~SANOFI PASTEUR~U1532AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0235112	03/17/2005	ID	57.0	57		M	01/26/2005	Two hours after vaccination- client felt burning-oozing and deep pain at site. He (R.A.) removed band aid (non-latex) and discovered 2 small blisters. He cleaned the area and applied ointment. Today 01/26/2005 scab has formed area looks clean and free of infection.									Y	01/19/2005	01/19/2005	0		PVT	PVT	Neurontin, Toprol, Lipitor				ID5007	1						1	Blister; Pain	FLU3~SANOFI PASTEUR~U59+6AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SMITHKLINE BEECHAM~AHBVB004AA~3~IM~LA~HEP B (ENGERIX-B)~1|IPV~SANOFI PASTEUR~X1006-2~UNK~SC~LA~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0771P~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0235146	03/17/2005	MA		68		F	12/14/2004	Severe redness swelling in right arm by bed time 12/07/2004 Seen at walk in Keflex given.12/08/2004 Seen at ER given Benadryl (IM), Tetracycline 12/09/2004 Swelling and redness pain from wrist to above shoulder/ 12/13/2004 all redness swelling  has subsided only tenderness at inj./ site now.				Y					Y	12/07/2004	12/07/2004	0		UNK	UNK						1						1	Erythema; Injection site pain; Oedema peripheral	FLU3~SANOFI PASTEUR~U155AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0232187	03/18/2005	MA	81.0	81		F	03/17/2005	From initial information received on 3/11/05 from the patient regarding an adverse event, it was reported that an eighty-one year old female patient received a dose of FLUZONE, lot number not reported, administered in the left arm on 11/17/04. The route of administration was not reported. Two days later, on 11/19/04, the patient developed generalized paralysis. She was seen by several physicians and was treated with 15mg Cortisone that has helped the range of motion in her arms. At the time of the report, the patient feels mainly generalized pain of her entire body and numbness of her fingers during rest. She also has limited range of motion of her arms. Per the patient, she currently is seeing a rheumatologist for a follow up evaluation. She has not recovered from these events. (OMIC)				Y					N	11/17/2004	11/19/2004	2		PUB	PUB			The patient has no known allergies. She received many doses of flu vaccine before and did not have any illness at the time of vaccination.		200500549	1						2	Arthritis; Pain; Hypoaesthesia; Joint range of motion decreased; Pain; Paralysis	FLU3~SANOFI PASTEUR~U1448AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0235150	03/18/2005	IL	31.0	30		M	03/16/2005	From initial information received on 3/8/05 from another manufacturer (reference number WAES0501USA04558), initially reported by a nurse, regarding an adverse event, it was reported that a 30 year old male patient received his first dose of FLUZONE, lot number U1531AA, administered in the left deltoid (route of administration not reported), and his first dose of PNEUMOVAX 23, lot number 647724/0946N, administered IM in the left deltoid on 1/7/05 at 10:00 AM. Two days later, at 9:00 AM, the patient developed redness, swelling, tenderness, and pain at the site of injection, as well as, nausea, vomiting, and severe headache. The patient was seen in the emergency room that same day. Reportedly, the patient stated that it hurt to raise or move the arm. He was treated with Augmentin and IM Rocephin. On exam, the patient had a fever as well as arm redness, warmth, and swelling. On 1/10/05, per the nurse, the redness, pain, swelling and warmth at the site had increased with decreased range of motion in the arm. The patient was diagnosed with left arm cellulitis and was admitted to the hospital. Medical records indicated that the chief complaint at admission included weakness, nausea, vomiting, headache, and pain and redness in the left arm. During the hospital course, the patient was treated with IV fluids, Unasyn, Solu-Medrol, Reglan, Entex PSE, and Darvocet-N 100 as well as saline spray and amantadine hydrochloride. Influenza AB screen was presumptive negative for the influenza A or B antigen. The patient was discharged from the hospital and recovered on 1/24/05.				Y	Y				Y	01/07/2005	01/09/2005	2	Laboratory tests obtained on 1/9/05 included a WBC of 12.8 with segs of 88% and a sed rate of 35mm/hr. Total cholesterol, HDL, LDL, WBC, neutrophil count and the sed rate were all increased. Influenza AB screen was presumptive negative for the influenza A or B antigen. 1/7/05: Glomerular filtration - 105ml/l; Plasma LDL-C - 72u/L; Serum aspartate - 42 u/L; Serum cholesterol - 216mg/d; Serum HDL-C - 45mg/d; Urine specific gravity - 1.036; Urine squamous - rare. 1/9/05: Hemoglobin - 14g/dl; Erythrocyte - 33mm/h; RBC - 4.84 10^6; WBC - 12.8 10^3; Hematocrit - 42.5%. 1/10/05: Absolute neutrophil - 8.76K/cu; Erythrocyte - 43mm/h; Glomerular filtration - 46u/L; Serum alanine - 46u/L; WBC - 10.95K/cu. 1/12/05: Erythrocyte - 36mm/h.	PVT	PVT	Advair; Accolate; Ibuprofen; Tylenol; Zithromax	Upper respiratory tract infection.	The patient has a history of asthma. He had sinusitis and upper respiratory tract infection at the time of vaccination. Reportedly, he has no known allergies.		200500515	1						1	Cellulitis; Headache; Hypokinesia; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Laboratory test abnormal; Medication error; Nausea; Pain; Pyrexia; Vomiting; Alanine aminotransferase increased; Aspartate aminotransferase increased; Asthenia; Blood cholesterol increased; Cellulitis; Erythema; Feeling hot; Headache; Hypokinesia; Injection site oedema; Injection site pain; Injection site reaction; Laboratory test abnormal; Nausea; Pyrexia; Red blood cell abnormality; Tenderness; Urine analysis abnormal; Vomiting; White blood cell count increased; White blood cell disorder	FLU3~SANOFI PASTEUR~U1531AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0946N~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U15311AA~1~~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0946N~1~IM~~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0235162	03/18/2005	NJ	4.0	4		M	03/18/2005	Swollen, tense and red right upper arm, around injection site. This occurred 72 hours after vaccination and resolved in 3 days.									Y	03/09/2005	03/11/2005	2		PVT	PUB	N/A					1						1	Injection site erythema; Injection site swelling; Tension	DTAP~SANOFI PASTEUR~U1342AB~5~~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1418AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1038~4~~RA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0235175	03/18/2005	CA	4.0	4		M	03/18/2005	Redness, Swelling, Warm to touch.  Patient started on Keflex 250ml/5mg 3ml q8h x7days. Follow up report received on 04/28/2005:  Reaction on left arm.									Y	03/17/2005	03/17/2005	0		UNK	UNK		none	none			1						1	Injection site erythema; Injection site swelling; Injection site warmth	DTAP~SANOFI PASTEUR~U1343AA~4~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1504AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1240~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0468P~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0229498	03/21/2005	KY	4.0	4		M	01/04/2005	From initial information received on 11/19/2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that a four year old male patient received Daptacel, lot number C2044AA, administered intra muscularly in the left arm, Fluzone SV '2004-'2005 USP, lot number U1380AA, administered intra muscularly in the left arm, Ipol, lot number X1040, administered subcutaneously in the right arm, and MMR/Measles, mumps Rubella vaccine, lot number 1039N, manufactured by Merck and administered subcutaneously in the right arm on 11/05/2004 at 11:00am. The next day on 11/06/2004, the patient developed a severely swollen left arm from the elbow to the shoulder with redness. The patient recovered from these events. The reporter in this case is the same reporter as for case 200403768.				Y					U	11/05/2004	11/06/2004	1		PVT	PVT					200403767	1						3	Oedema peripheral	DTAP~SANOFI PASTEUR~C2044AA~5~IM~LA~DTAP (DAPTACEL)~3|FLU3~SANOFI PASTEUR~U1380AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|IPV~SANOFI PASTEUR~X1040~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~3|MMR~MERCK & CO. INC.~1039N~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~3	USA	Emergency room visit	Influenza
0235237	03/21/2005	FL	1.34	1	.3	M	02/28/2005	Generalized Erythematous Papular lesions with crusting in different stages of healing.  Varivax administered 17 days ago on clinic visit on 02/28/2004.  Treatment:  Calamine lotion and Benadryl 12.5mg every 6 hours as needed for itching.									U	02/11/2005	02/24/2005	13	None	OTH	UNK		None	Heart Problems			1						1	Erythema; Pruritus; Skin ulcer	FLU3~SANOFI PASTEUR~U1472AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0316P~UNK~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0896P~UNK~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0235238	03/21/2005	TN	1.03	1	.0	F	03/04/2005	Approximately 9 PM on 02/22 had possible seizure (unconscious, eyes rolled back, generalized jerking, lasted 3-4 minutes) went to ER when found to be febrile without specific site of infection.  Influenza screen, CBC, Electrolytes, Glucose, BUN, Creatine, Ca, all normal, UA Urine and Blood Cultures negative; diagnosis was acute febrile illness with febrile seizure.  Released home without specific treatment except antipyretics.				Y					Y	02/08/2005	02/22/2005	14	CBC, Electrolytes, Glucose, BUN, Creatine, CA - all normal.  UA, Urine and Blood Cultures - negative.	PVT	UNK	None	None	Single urinary tract infection; reactive airway disease, recent fall off in weight.		TN05012	1						1	Febrile convulsion	DTAP~SANOFI PASTEUR~C1699AA~4~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UE384AA~4~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1299N~UNK~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A74400B~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0654P~UNK~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0235239	03/21/2005	MI	1.13	1	.1	M	03/01/2005	On 02/25/2005 infant had hives around DTAP site- right leg and also on face.  Also, had some difficulty swallowing and had non-stop fussing and crying, per Mom.  Taken to ER that same evening, he was given a dose of Tylenol and a dose of Atarax in the ER for what was described as a vesiculopapular rash and discharged that same evening with no acute distress.				Y					Y	02/23/2005	02/25/2005	2	None noted on hospital records.	PUB	PUB	None	Runny nose, mild diarrhea	None		MI2005005	1						1	Dysphagia; Irritability; Rash papular; Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~A639A2~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1527AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0235240	03/21/2005	MI	1.1	1	.1	F	01/31/2005	Received PCV7, HIB in left thigh, and flu shot in right thigh.  MMR in right arm subcutaneously, and VAR in left arm subcutaneously.  Immediately after vaccines given, nurse noticed a dollar sized reddened area at injection site.  Two inches in size on both arms extending to elbow, warm to touch on both arms.  Baby had no signs of Physical assessment done in ER.  Vital signs normal, pulse ox 98%.  No treatment needed.  Diagnosis:  Allergic reaction resolved.  Referred to Pediatrician.				Y					Y	01/24/2005	01/24/2005	0		PUB	PUB	None		No known allergies or birth defects, medical condition as known Per Mom.		MI2005003	1						1	Hypersensitivity; Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U1404RR~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0230P~4~IM~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0348P~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~4404B~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0657P~UNK~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0235241	03/21/2005	AL	67.0	66		F	02/22/2005	Tachycardia, parasthesia (up and down the line) 10 minutes after injection.  Heart rate 112 and irregular, 3 minutes later patient complained of tightness in her throat.  Patient refused ambulance transfer to ER. Medical records state warm, itching, reaction aggreviated. msv				Y					Y	12/10/2005	12/10/2005	0		PUB	OTH		None cited	History of heart palpitations.  Medical records states hypertension. msv		AL0432	1						1	Condition aggravated; Paraesthesia; Pruritus; Tachycardia; Throat tightness; Vasodilatation	FLU3~SANOFI PASTEUR~U1531AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0235375	03/24/2005	AR	20.0	20		M	03/17/2005	Pt was found dead in bed by mother on 11/06/2004. Mom reports pt c/o feeling like he had the flu on Friday night 11 PM, had a cough x 3 days, and a rash on chest with c/o itching on chest and back. He had worked all night 11/04/2004 painting in a trailer. He went to sleep at approximately 5:00 PM 11/05, snored loudly, unable to awaken. 3/30/05 Received Autopsy Report which revealed COD as myocarditis.	Y	11/06/2004							N	11/02/2004	11/06/2004	4	Possibly with autopsy.	OTH	PUB	NONE				AR0502	1						1	Cough; Influenza like illness; Myocarditis; Pruritus; Rash	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0235392	03/24/2005	NH	1.02	1	.0	F	03/24/2005	Developed petechial rash on 12/25/04.  Platelets 18k on 12/27, dropped to 5k on 12/29.  Patient started on Orapred 2mg/kg/day divided BID with taper over 3-4 weeks.  Patient's care transfered to pediatric hematologist.  Platelets have rebounded, not sure of time frame. Information from Medical records states bruising. msv			Y						Y	12/08/2004	12/25/2004	17	as above Information from Medical records state abnormal lab results, decreased platelets, liver function abnormal.	UNK	UNK	none	URI	none			1						1	Ecchymosis; Laboratory test abnormal; Liver function test abnormal; Petechiae; Platelet count decreased; Thrombocytopenia	FLU3~SANOFI PASTEUR~u1403AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~1040~3~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0347P~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0656P~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Life Threatening	Influenza
0235455	03/25/2005	CA	1.26	1	.3	M	03/25/2005	Erythema, Pain, on medial left thigh, site of injection. Dtap site on left.									Y	03/22/2005	03/23/2005	1		PVT	PUB						1						1	Erythema; Injection site pain	DTAP~SANOFI PASTEUR~U1343AA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UK567AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE479A~4~IM~RL~HIB (ACTHIB)~1	USA		Influenza
0235414	03/27/2005	AZ	66.0	65		F	03/27/2005	THROAT SWELLING STARTED 01/08/05 ADMITTED TO  HOSPITAL 01/11/O5 DIAGNOSIS AS EPIGLOTTITIS IN ER. ON 01/12/05 ENT DR DIAGNOSIS DID NOT CONFIRM EPIGLOTTITS. HIS DIAGNOSIS WAS A VIRUS (SPECIFIC TYPE OF VIRUS NOT KNOWN). Discharge summary states tissue swelling. msv				Y	Y	4			U	01/06/2005	01/08/2005	2	CHECK WITH FOR ALL LABS & TESTS. Medical records state gram positive culture. msv	UNK	UNK	XALATAN  0.005% 1-DROP EA EYE  ATENOLOL 25MG  1-PER DAY LEVOXYL 0.1MG 1-PER DAY	NO	OPEN ANGLE GLAUCOMA HIGH BLOOD PRESSURE THYROID Medical records state allergy. msv			1						1	Bacterial infection; Epiglottitis; Oedema; Pharyngeal oedema; Viral infection; Dysphagia; Fatigue; Pharyngitis; Viral infection; Fatigue; Throat tightness; Weight decreased	FLU3~SANOFI PASTEUR~U1579AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1579AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~U1579AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Hospitalisation	Influenza
0214176	03/28/2005		40.0			F		A report was received from a physician via another manufacturer (Ref WAES0501USA00553) on 17Mar05 concerning a 40 year old female vaccinee. The vaccinee has a history of asthma, seasonal bronchitis, drug hypersensitivity and migraines. She has allergies to sulfisoxazole diolamine (Sulfium), nitrofurantoin (macrodontin) and prochlorperazine maleate (Compazine IV). The vaccinee has no allergies to eggs, thimerosal, contact lens solution, mercury or latex. She has no history of Guillian Barre Syndrome, neurologic conditions or reactions to flu shots. The vaccinee was not receiving immunosuppressive therapy. The vaccinees concomitant medications include antihistamines. On 10Dec03, the vaccinee received Fluvirin (batch 765885) in her left arm and Pneumovax 23, 0.5ml, in her right arm. On the same day, the vaccinee developed soreness at the Pneumovax injection site followed by a rash and hives on the right side of her body, joint pain and fatigue. At the time of vaccination, the vaccinee did not have a fever or active infection and her body temp was 97.3 deg F. On 22Dec03 the pt developed hives and a tight chest. On 23Dec03, the vaccinee experienced coughing and a tight chest. She has also developed pain in her hip, knee and up and down her spine. Her skin was also hyper tender when touched. The vaccinee appeared well and was well nourished. Progress notes indicated that the vaccines had an ongoing reaction to pneumococcal 23v polysaccharide vaccine. The vaccinee also experienced discomfort during urination for which she was prescribed phenazopyridine hydrochloride (Uristat). On 23Dec03, the vaccinee was receiving hydroxyzine hydrochloride (Atarax). She was also receiving methyl prednisolone (Medrol Dosepak). Laboratory test read, blood pressure 136/100, body temp 98.1, total heartbeat count, 98. On 15Jan04, a laboratory test read, BSR 8. On 01Mar04, the vaccinee was seen by her physician and it was noted that her knees, shoulders, elbows and back were sore. Also her knees were swollen, the right knee more than the left and had difficulty with stairs. There was some soft tissue swelling above and lateral to her right knee and there was joint line tenderness. Her left arm and anterior chest was sore to the touch, her chest was clear and she had no spinal tenderness. It was reported that these symptoms, due to the serum sickness reaction were slowly improving. Her energy levels are returning and she is doing more, but is still uncomfortable. Arthritis was ruled out. The vaccinees medication include, carbinoxamine maleate, hydrocodone bitartrate and pseudoephedrine hydrochloride (Histex) 2 tsp every 4 hours. Laboratory tests on 01Mar04 showed, Blood pressure, 140/90 and body temperature 98.5. Further laboratory tests on 28Jun04 showed, Lyme disease assay, negative, serum ANA, negative, serum rheumatoid factor, 8.7 and ESR 2. The reported considers these events to be disabling and life threatening.								Y	U	12/10/2003	12/10/2003	0	Blood Pressure 12/23/03, 03/01/04, Body temp 12/10/03, 12/23/03, 03/01/04; Erythrocyte 01/15/04, Sedimentation Rate 06/28/2004, lyme disease assay 06/28/04  (ELISA) negative, Serum ANA 06/28/04 negative, serum rheumatoid factor 06/28/04, Total heartbeat count 12/23/03.	UNK	UNK	Antihistamines		History of asthma, seasonal bronchitis, allergic bronchitis, drug hypersensitivity and migraines. Allergies to sulfisoxazole diolamine (Sulfium), nitrofurantoin (Macrodantin) and prochlorperazine maleate (Compazine IV). No allergies to eggs, thimerosal, contact lens solution of mercury or latex sensitivity. No previous history of reactions to flu shots. No history of Guillian Barre syndrome or neurologic conditions. No immunosuppressive therapy or condition that affects the immune system.		CVOX200500039	1						3	Arthralgia; Asthenia; Chest discomfort; Chest pain; Cough; Dysuria; Fatigue; Hyperaesthesia; Injection site pain; Laboratory test abnormal; Oedema peripheral; Rash; Serum sickness; Urticaria; Arthralgia; Chest discomfort; Cough; Dysuria; Fatigue; Gait disturbance; Injection site pain; Laboratory test abnormal; Myalgia; Oedema; Rash; Serum sickness; Urticaria	FLU3~EVANS VACCINES~765885~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~2|FLU3~EVANS VACCINES~765885~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~3	USA	Disabling	Influenza
0235471	03/28/2005	CA	24.0	23		F	03/23/2005	Subcutaneous tissue defect-resembling gradual latent onset of fat necrosis 8 mm in diameter area 3.5mm deep.									N	01/07/2005	02/01/2005	25		MIL	UNK	Tylenol		Pregnant, Asthma			1						1	Necrosis	FLU3~SANOFI PASTEUR~U1515AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0235472	03/28/2005	MI	48.0	47		M	03/18/2005	On 01/27/2005 Pt reports experiencing a continous ache from shoulder to left elbow and slight loss of grip in left hand. No redness, no swelling at injection site, no fever. Used no OTC meds, no compresses, lasted 2 1/2 weeks. Then left arm ok. But 2 weeks later started experiencing tingling from shoulder to fingertips. Not continous but frequently. Has not seen a doctor. Pt states he works out at gym 3-4 times a week and does lift weights. He also travels much.									U	01/26/2005	01/27/2005	1		PUB	PVT	NONE	NO	NONE		M12005013	1						1	Muscular weakness; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U1569AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~VHA841A4~2~IM~LA~HEP A (HAVRIX)~1|TD~AVENTIS PASTEUR~U1000AA~UNK~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0235475	03/28/2005	MI	79.0	78		M	02/25/2005	Client began experiencing sharp pain radiating across right shoulder, behind the ear and back of neck during week of 12/25/2004. Client states pain is a constant pain and that is reduced to an aching pain after taking Aleve every 4-6 hours and using a heating pad.				Y					U	11/29/2004	12/25/2004	26		PUB	PUB			Heart Disease		MI2005008	1						1	Neck pain; Pain	FLU3~SANOFI PASTEUR~U1499AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0512P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0235514	03/28/2005	NH	31.0	31		F	03/15/2005	Pt reports arm inflammed, painful, fever-did not call office to report or be seen. Pt was checked in office after 15 minutes with no reaction.									Y	01/27/2005				PVT	PVT	Wellbutrin, Celexa, Nexium, Loratadine, multi vitamin	migraine headache	Allergy to sulfa drugs and bee stings.		NH0504	1						1	Inflammation; Pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500352P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|PPV~MERCK & CO. INC.~1138N~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0235414	03/29/2005	AZ	66.0	65		F	02/22/2005	Extreme tiredness, could not swallow saliva. Virus? Epiglottis? Discharge diagnosis unknown.				Y	Y	2			Y	01/06/2005	01/11/2005	5	Sputum culture; Stress test	PUB	PVT		NONE	UNK			1						2	Bacterial infection; Epiglottitis; Oedema; Pharyngeal oedema; Viral infection; Dysphagia; Fatigue; Pharyngitis; Viral infection; Fatigue; Throat tightness; Weight decreased	FLU3~SANOFI PASTEUR~U1579AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1579AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~U1579AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Hospitalisation	Influenza
0235525	03/29/2005	GA	45.0	45		M		This is a non serious spontaneous case from a consumer who reports nasal congestion after receiving FluMist. The reporter did not provide causality between events and FluMist. This case is submitted according to the agreement for FluMist. On 08Mar05 a 45 year old male received FluMist IN and subsequently three days later experienced runny nose, nasal congestion, cough, and malaise. He treated himself with an unspecified over the counter medication for his nasal congestion. On 14Mar05, the pt claimed his symptoms are worse. The pt also developed fever of 102 degrees F on 14Mar05. On 15Mar05, the pt stated he is feeling better. The pt has not yet recovered. The reporter did not provide causality between events and FluMist vaccination.									N	03/08/2005	03/11/2005	3		PUB	OTH					MEDI0003019	1						1	Cough; Malaise; Nasal congestion; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500340P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0235551	03/29/2005	FL	0.61	0	.6	F	03/29/2005	PT WENT TO THE EMERGENCY DEPT ON 03/13/05 D/T UPPER RESP INFECTION ALSO C/O FEVER AND SWELLING AT INJECTION SITE WHERE IMMUNIZATIONS WERE GIVEN 5 DAYS PREVIOUSLY. FOLLOWED UP HERE ON 03/15/05 AND STILL HAD SOME INDURATION ON LEFT THIGH AREA. WAS GIVEN AMOXIL IN WHICH PT IS ALLERGIC & WAS DISCONTINUED.				Y					Y	03/08/2005	03/11/2005	3	NONE	UNK	UNK	NONE	NONE	POSSIBLE AMOXIL ALLERGY			1						1	Injection site induration; Injection site swelling; Injection site warmth; Upper respiratory tract infection	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A010BA~2~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1487AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1016P~2~IM~LL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~A67182A~2~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0235567	03/30/2005	NY	49.0	49		F	03/29/2005	From initial information received on 29Nov04 from the pt regarding an adverse event occurring, it was reported that this 49 year old female pt received a Fluzone SV 2004-2005 USP vaccination in Nov 2004, the lot number and route of administration were not reported. The pt stated she received the vaccination a couple of weeks ago (exact date unk). Within 24 hrs, the pt developed chills, lightheadedness, flu symptoms, tightness in chest and swollen feet. She has not been evaluated by a physician, but had an appt scheduled for 30Nov04. The pt's recovery status is currently reported as not recovered. From additional information received on 23Mar05 from the responsible physician, this case is being upgraded to serious based upon new medical information. From additional information received on 23Mar05 from the responsible physician, it was reported that the pt received a dose of Fluzone SV 2004-2005 USP vaccine, lot number U1498AA, administered in the left deltoid on 03Nov04. On 29Nov04, the pt complained of shortness of breath, dizziness and fatigue. She was seen by the physician on 01Dec04 and hospitalized on 04Dec04 with advanced sarcoidosis. Per the reporter, the pt had not recovered from these events.				Y	Y				N	11/03/2004	11/29/2004	26	From additional information received on 3/23/05 from the responsible physician, it was reported that the patient's CBC, LFT's and TSH tests were all normal. Her chest x-ray test showed extensive sarcoid.	PVT	PVT			The patient's past medical history is significant for sarcoidosis. She is also environmental and chemical sensitive. She did not have any illness at the time of vaccination, nor was she taking any other medications at the time of vaccination.		200403829	1						1	Chest discomfort; Chills; Dizziness; Dyspnoea; Fatigue; Influenza like illness; Oedema peripheral; Sarcoidosis	FLU3~SANOFI PASTEUR~U1498AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0235579	03/30/2005	WI	22.0	22		F	03/30/2005	Localized red painful erythema at injection site. 2 injections given in the R arm. #1 2cm oval diameter red not raised, no vesicles noted. #2 1cm in diameter and inferior on arm to #1.				Y					Y	03/23/2005	03/26/2005	3		MIL	MIL						1						1	Injection site erythema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~1~SC~RA~MENINGOCOCCAL (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0235621	03/31/2005	FL	80.0	80		F	01/05/2005	Lower extremity weakness, difficulty walking, difficulty lifting leg or self from sitting upright position. Per follow up report recieved on 06/23/2005:  Patient's recovery status is unknown.				Y	Y		Y		U	12/08/2004	12/09/2004	1	MRI, Spinal tap with spinal fluid analysis	UNK	PVT		E. Coli; Pyelonephritis and Septicemia				1						1	Difficulty in walking; Hypokinesia; Muscular weakness	FLU3~SANOFI PASTEUR~U1552AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0235414	04/01/2005	AZ	66.0	65		F	03/31/2005	From initial information received on 3/29/05 from the patient regarding an adverse event occurring in the USA, it was reported that the 65 year old female received an annual dose of FLUZONE, lot number U1579AA, on 1/6/05. The route and site of administration were not reported. Two days later, on 1/8/05, the patient woke up feeling as though something was stuck in her throat. She was seen in an emergency room and was hospitalized. She was initially diagnosed with epiglottitis, but that diagnosis was later ruled out. She was treated with antibiotics and saline. The patient reported that she has had a ten pounds weight loss and still feels tired. She also stated that her blood work is not right, such as her thyroid. At the time of this report, the patient had not recovered from these events.				Y	Y				N	01/06/2005	01/08/2005	2		UNK	UNK	Atenolol; Levoxyl; Xalatan		The pt has a history of rhinitis. It was reported that she has  no known allergies, but can not take Sulfa. She has received annual influenza vaccinations and did not have any illnesses at the time of vaccination.		200500628	1						3	Bacterial infection; Epiglottitis; Oedema; Pharyngeal oedema; Viral infection; Dysphagia; Fatigue; Pharyngitis; Viral infection; Fatigue; Throat tightness; Weight decreased	FLU3~SANOFI PASTEUR~U1579AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1579AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~U1579AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Hospitalisation	Influenza
0235644	04/01/2005	PA	0.75	0	.8	M	03/31/2005	This case was considered medically important for the event of developmental coordination disorder (OMIC). Information regarding Prevnar was received from a physician regarding a 12 month old male patient who exhibited a developmental coordination disorder on 2/18/05. At 9 months of age, the patient received his fourth dose on 11/16/04. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 11/16/04. Dose regimen was 1 dose (IM). Concomitant therapy included Hepatitis B vaccine and influenza virus vaccine. A physician reported that on 11/16/04 during the patient's 9 month office visit, the patient inadvertently given what was thought to be a third dose of Prevnar. This dose was actually the patient's fourth dose, and was administered in accordance to an incorrect immunization data entry on the patient's chart. At this visit, the patient's Denver assessment and appearance were noted as fine. The only questionable note in the chart was that the patient was only sometimes pulling to stand. On 2/18/05, the patient received a fifth dose of Prevnar. The physician noted at this time that the patient was not standing or taking steps and subsequently classified the patient's gross motor skills as floppy. The child's fine motor skills were assessed as good. The patient was referred to the hospital where his gross motor skills were also assessed as floppy. An appointment has been scheduled with a neurologist in April. No additional information was available at the time of this report.									U	11/16/2004	02/18/2005	94	UNK	PVT	PVT	UNK	UNK	UNK		HQWYE432328MAR05	1						1	Coordination abnormal; Hypokinesia; Medication error	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~3~~~HEP B (NO BRAND NAME)~1|PNC~PFIZER\WYETH~~4~IM~~PNEUMO (PREVNAR)~1	USA		Influenza
0235648	04/01/2005	IA	1.47	1	.5	F	03/22/2005	On clinic visit 03/22/05 for #2 Influenza; mother reported that with immunization on 01/25/05, child had a reaction. The reaction occurred about 1/2 hour after arriving home, child was shaking and skin was red and blotchy. Seen by doctor and temperature was 102-103 degrees. Given antibiotic for possible ear infection, used tylenol/ibuprofen overnight and had no further temperature.				Y					Y	01/25/2005	01/25/2005	0	NONE	PUB	PUB	NONE	Doctor diagnosed ear infection after injection on 01/25/05.	Patient was premature. No other medical conditions.			1						1	Rash macular; Tremor	DTAP~GLAXOSMITHKLINE BIOLOGICALS~634A2~4~~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1405AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0095P~4~~LA~HIB (PEDVAXHIB)~1	USA	Emergency room visit	Influenza
0235674	04/01/2005	DC	72.0	71		M	04/01/2005	pt received flu vaccine on 2/23/05. after that time experienced swelling and pain and decreased range of motion in right shoulder. presented on 3/4/05 with a frozen right shoulder. was referred to the emergency department. Since that time patient has regained full range of motion in shoulder and trend of improvement of his symptoms.				Y					Y	02/23/2005	02/23/2005	0		UNK	UNK	hytrin 1.mg qhs  albuterol mdi prn	RAD	enlarged prostate asthma			1						1	Joint range of motion decreased; Pain; Swelling	FLU3~SANOFI PASTEUR~u1516aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~O8878~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0235700	04/04/2005	AL	63.0	63		F	03/15/2005	Patient stated about 7 days had right arm soreness, with redness and rash on arms, face and stomach. Rash subsided but had painful walking, bottom of feet hurt, soreness of joints in neck, knees, arms and swelling of hands. Stated joints are better now but hands sore and swollen some. Encouraged patient to see doctor. Reported no medication on date of consult.									U	02/24/2005	03/07/2005	11	NONE	PUB	PVT	Fosamax and Aleve		NONE		AL0504	1						1	Arthralgia; Erythema; Hypokinesia; Oedema peripheral; Pain; Rash	FLU3~SANOFI PASTEUR~UE1560AB~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X12442~UNK~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0416P~1~SC~RA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|PPV~MERCK & CO. INC.~0456P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0235728	04/04/2005	WA	73.0	73		F	04/04/2005	Left upper arm pain immediately after injection. Still having pain over four months later. Very upset. Saw me (her primary MD) today for evaluation. Referred for physical therapy.				Y					N	11/24/2004	11/24/2004	0	None yet.	UNK	UNK	Levoxyl, Pamidronate IV, Bextra, Colchicine, Calcium, Vitamins	Osteoporosis, Hypothyroidism, Pseudogout, Glaucoma	None (see #18)			1						1	Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0229354	04/05/2005	IL		0	.5	F	12/06/2004	From initial information received on 11/17/2004 from a registered nurse regarding an adverse event  occurring in the USA, it was reported that a six month old female patient received her 3rd dose of Act Hib, lot numberUE084AA (Aventis Pasteur SA lot #X0076-2), administered IM in the right lower thigh, her 3rd dose of Daptacel, Lot number C2044AA, administered IM in the right upper thigh, her 1st dose of Fluzone SV '2004-'2005 USP Pediatric dose, lot number C1415AA (this lot number does not match a known Aventis Pasture product) administered IM in the lower LT and a 3rd dose of Prevnar (manufacturer Lederle) lot numbers A79659B, administered IM in the left upper thigh at 11:00 AM on 11/12/2004. Within two minutes the patient was covered with hives from head to tie. No anaphalaxus or respiratory distress was noted. The patient remained alert and playful she was treated with oral Benadryl 2.75ml and the hives faded within 20 minutes. The pt was sent home and is to follow up with an allergist. The pt recovered form this event									Y	11/12/2004	11/12/2004	0		PVT	PVT					200403698	1						2	Respiratory distress; Urticaria	DTAP~SANOFI PASTEUR~C2044AA~3~IM~RL~DTAP (DAPTACEL)~2|FLU3~SANOFI PASTEUR~C1415AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~SANOFI PASTEUR~X0076~3~IM~RL~HIB (ACTHIB)~2|PNC~PFIZER\WYETH~A79659B~UNK~IM~LL~PNEUMO (PREVNAR)~2	USA		Influenza
0235761	04/05/2005	NY		0	.5	F	12/08/2004	From initial information received on 10/22/2004 from a health care professional regarding and adverse event occurring in the U.S. A., it was reported that a six month old female patient received her 1st dose of Fluzone SV '2004-2005 USP, lot number U1454AA, administered IM in the RT on 10/16/2004. Two days later on 10/18/2004, the patient developed a pimple like rash on her upper chest, back and shoulders. RAST testing to egg white gelatin was not ordered. Reportedly the patient recovered from these events.									Y	10/16/2004	10/18/2004	2		PVT	PVT					200403451	1						1	Dermatitis acneiform	FLU3~SANOFI PASTEUR~U1454AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0235764	04/05/2005	OH	1.51	1	.5	M	01/05/2005	From initial information received on 19Nov04 from a health care professional regarding an adverse event occurring, it was reported that an 18 month old male pt received his third dose of Daptacel, lot number C1700AA, administered in the left thigh, a dose of Ipol, lot X1212, administered in the right thigh and a dose of Fluzone SV 2004-2005 Pediatric dose, lot number U1389AB, administered in the right thigh on 18Nov04. Routes of administration were not reported. That same day, the pt developed a diffuse, red, and warm reaction on his thigh. Reportedly, he was able to walk but the thigh was very swollen. The pt previously received a dose of Acthib,lot number UE443AA, administered in the left thigh, a dose of Fluzone SV 2004-2005 Pediatric dose, lot number U1389AB, administered in the left thigh and a dose of Varivax, lot number 0278P, manf Merck, administered in the right thigh on 18Oct04. Routes of admin of these vaccines were not reported. Concomitant medication at the time of vaccination included Pulmicort and Singulair. Pt's pre-existing medical conditions include Alpha Anti-Trypsin Deficit, Reactive Airways Disease and chronic otitis media. He has no known allergies. It is unk whether the pt recovered from these events. The reporter of this case is the same reporter as cases 200403769, 200403771, 200403772, 200403773 and 200403774.									U	11/18/2004	11/18/2004	0		UNK	UNK	Pulmicort, Singulair		Pt preexisting medical conditions include Alpha anti-trypsin. Deficit and Reactive Airways Disease as well as chronic otitis media. He has no known allergies. The reporter denied any illnesses at the time of vaccination.		200403770	1						1	Feeling hot; Injection site erythema; Injection site oedema	DTAP~SANOFI PASTEUR~C1700AA~4~~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1389AB~UNK~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1212~UNK~~RL~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0235820	04/06/2005	DE	21.0	20		F	02/04/2005	Sinus pain, Nosebleeds, Headache				Y						01/26/2005	02/02/2005	7		MIL	MIL						1						1	Epistaxis; Headache; Pain	FLUN3~MEDIMMUNE VACCINES, INC.~500356P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0235821	04/06/2005	CA	4.0	4		F	03/29/2005	About 12 hr after influenza vaccine was administered, child had severe lower extremity pain, weakness, refused to walk, was sent to ER.				Y						03/28/2005	03/29/2005	1		PVT	PUB	Albuterol MDI	URI	NONE			1						1	Asthenia; Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U1467AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0235822	04/06/2005	MS	22.0			M	01/19/2005	Small pox reaction vaccination , red raised, rash all over body- urticaria, and fever. Follow up report received 05/12/2005:  Patient in transit, condition elevated.  Patient gone from base.				Y						01/17/2005	01/18/2005	1		MIL	MIL						1						1	Pyrexia; Rash; Rash erythematous; Urticaria	FLUX~UNKNOWN MANUFACTURER~U1557AA~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~0850~UNK~IM~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0235867	04/06/2005	MA	53.0	53		F	04/06/2005	Swelling, pain, faint erythema from injection site to elbow. Allergic to PCN causes throat and facial swelling. Prescribed ____, diagnosis early cellulitis vs immunization reaction.				Y					U	04/04/2005	04/05/2005	1	NONE	PVT	OTH		NONE	Allergic to: Sudafed, Sulfa, Doxycycline, Fosamax, Amox			1						1	Injection site pain; Injection site swelling	FLU3~PARKDALE PHARMACEUTICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1|PPV~MERCK & CO. INC.~0486P~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0231358	04/07/2005	OR	1.59	1	.6	M	04/07/2005	FROM ED NOTE:  This is a 19-month-old with a previous history of febrile seizure who presents today for the same complaint.  The patient was in his usual state of good health this morning.  At approximately 3:30 this afternoon, mom comments that the patient was playing around the house.  The patient fell to the ground and stiffened and began to have jerking movements of both arms and both legs.  This activity continued for approximately three minutes.  The parents administered Diastat and the seizing activity ceased after a total of five minutes.  Of interesting note, this patient's previous seizure activity happened at approximately 7 months of age and was 5-7 days after immunizations.  This patient received immunizations again yesterday.				Y					Y	12/14/2004	12/15/2004	1	none	UNK	UNK		none	febrile seizures	seizure~DTaP (Acel-Imune)~3~0.60~In Patient|seizure~DTaP (no brand name)~~0.00~In Sibling		1						2	Condition aggravated; Convulsion; Dyskinesia; Fall; Musculoskeletal stiffness; Vaccine positive rechallenge	DTAP~GLAXOSMITHKLINE BIOLOGICALS~634A2~4~IM~LL~DTAP (INFANRIX)~2|FLU3~SANOFI PASTEUR~U1469AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|MMR~MERCK & CO. INC.~1300N~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~2|PNC~PFIZER\WYETH~A74398C~4~IM~RL~PNEUMO (PREVNAR)~2	USA	Emergency room visit	Influenza
0235898	04/07/2005	PA	76.0	75		F	03/30/2005	Achy all over in all joints, to severe pain. Shot given at Clinic on 12/17/2004.									Y	12/17/2004	12/17/2004	0		PUB	OTH						1						1	Arthralgia; Pain; Gait disturbance; Myalgia	FLU3~SANOFI PASTEUR~V1561AA~UNK~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~~1~~GM~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0235899	04/07/2005	CA	48.0	48		F	04/01/2005	Localized induration at left deltoid 5 cm x 10cm with surrounding erythema. No warmness. TTP with decreased ROM of extesion, Denies chills, temp 97.2 on exam. Advised to take NSAIDS for Pain and swelling. Advised to go to PMD or ER if condition worsens.										03/25/2005	03/31/2005	6		PUB	PUB					CA050011	1						1	Erythema; Injection site erythema; Injection site induration; Joint range of motion decreased; Oedema; Pain	FLU3~SANOFI PASTEUR~UI556AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~UI2B0AA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0235913	04/08/2005	CA		1	.0	F	12/10/2004	temp 101.1- Fever started last night, 12/09/2004, about 8:00PM for which Tylenol was given PO. Rash on both arms and more on legs noted this AM by her mom. Hence, decided to come back to the clinic.									U	11/19/2004	12/09/2004	20		PUB	PUB						1						1	Pyrexia; Rash	FLU3~SANOFI PASTEUR~U1519AB~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~1215~2~IM~RL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0617N~UNK~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0711N~UNK~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0235932	04/08/2005	PA	75.0	74		F	04/09/2005	Shortness of breath, lung sounds of all fields decreased.				Y						10/14/2004	03/31/2005	168	3/31/05 rapid influenza screen: influenza A	PVT	PVT	long list for COPD, Asthma, DM	NONE	PCN, Prednisone, Lioresal Dilatrate.			1						1	Dyspnoea; Hypoventilation; Viral infection	FLU3~SANOFI PASTEUR~U1500AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0235980	04/11/2005	WA	0.87	0	.9	F	04/05/2005	24 hours after vaccine pt started with diarrhea and rash				Y					N	03/24/2005	03/25/2005	1		PVT	PUB						1						1	Diarrhoea; Rash; Diarrhoea; Rash	PNC~PFIZER\WYETH~A671840~3~IM~LL~PNEUMO (PREVNAR)~1|FLU3~SANOFI PASTEUR~U1484AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|PNC~PFIZER\WYETH~A67184D~3~IM~LL~PNEUMO (PREVNAR)~2	USA	Emergency room visit	Influenza
0235980	04/12/2005	WA	0.87	0	.9	F	04/06/2005	Rash and Diarrhea									N	03/24/2005	03/25/2005	1		PVT	PUB						1						2	Diarrhoea; Rash; Diarrhoea; Rash	PNC~PFIZER\WYETH~A671840~3~IM~LL~PNEUMO (PREVNAR)~1|FLU3~SANOFI PASTEUR~U1484AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|PNC~PFIZER\WYETH~A67184D~3~IM~LL~PNEUMO (PREVNAR)~2	USA		Influenza
0236011	04/12/2005	ND	32.0	31		M	02/22/2005	Member experienced chest pain over 18-19 Feb, was seen/treated in ER/admitted to cardiology. Discharge diagnoses: Pericarditis. Information added includes pain, PVC's. msv				Y	Y	1			Y	01/10/2005	02/19/2005	40	EKG at onset; Stress test; Echocardiogram information added abnormal EKG, lab test abnormal. msv	MIL	MIL	NONE	NONE	NONE		ND0505	1						1	Chest pain; Electrocardiogram abnormal; Laboratory test abnormal; Pericarditis; Ventricular extrasystoles	FLUN3~MEDIMMUNE VACCINES, INC.~500356P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0236012	04/12/2005	WA	50.0	50		F	04/07/2005	The morning after receiving a flu shot, Pt reports she awoke with no sensation from hips thru toes and elbows through finger tips. Has fatigue and episodes of loss of balance since then. Resolving, partially according to Pt.									Y	11/14/2002	11/15/2002	1		OTH	OTH			Neurologic symptoms (NOS)			1						1	Balance disorder; Fatigue; Paraesthesia	FLU3~SANOFI PASTEUR~U0971AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0236014	04/12/2005	NC	0.92	0	.9	M	04/05/2005	Diagnosed with Influenza 03/21/2005.				Y					Y	10/18/2004	03/21/2005	154	CLIA waived flu swab	PVT	OTH						1						1	Influenza	FLU3~SANOFI PASTEUR~U1417AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0236015	04/12/2005	NC	1.58	1	.6	F	04/05/2005	Diagnosed with Influenza 03/29/2005.				Y					Y	10/12/2004	03/29/2005	168	CLIA waived Flu swab	PVT	OTH						1						1	Influenza	FLU3~SANOFI PASTEUR~U1417AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0236016	04/12/2005	OR	72.0	72		F	04/08/2005	According to pt, she have experienced pain at injeciton site, arm and hand since the day she received her Flu shot (6 months). She saw her doctor a month later after the day of injection and took ibuprofen for 2 weeks after that they put her on cortisone shots and now she is in physical therapy.									U	10/11/2004	10/11/2004	0		OTH	OTH						1						1	Discomfort; Injection site pain	FLU3~SANOFI PASTEUR~U1440AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0236017	04/12/2005	NC	10.0	10		F	04/04/2005	Diagnosed with Influenza 03/19/2005				Y					Y	10/06/2004	03/18/2005	163		PVT	OTH						1						1	Influenza	FLU3~SANOFI PASTEUR~U1417AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~AVENTIS PASTEUR~U1011AA~UNK~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0236117	04/14/2005	AZ	1.16	1	.2	F	04/14/2005	Wheezing, congestion, fever 101.8 - to ER 1/9/05. Treated for croup, breathing Tx, Albuterol. Also Dx with ear infection; put on ABT's, steroids.				Y					Y	01/05/2005	01/09/2005	4		UNK	UNK		No	None		AZ0506	1						1	Croup infectious; Dyspnoea; Nasal congestion; Otitis media; Pyrexia; Wheezing	FLU3~SANOFI PASTEUR~U1465AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0236170	04/15/2005	RI	20.0	19		F	04/09/2005	Approximately 8 hours after receiving numerous vaccinations, I was attempted to be woke up by bunk mate who had felt me shaking down below. She said I was freezing cold, sweating and convulsions.									Y	06/11/2004	06/18/2004	7		MIL	MIL			Medication Allergy: Ceclor, Codeine			1						1	Convulsion; Depressed level of consciousness; Feeling cold; Hyperhidrosis; Tremor	FLU3~PFIZER\WYETH~757757~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|IPV~SANOFI PASTEUR~X0806~UNK~~~POLIO VIRUS, INACT. (IPOL)~1|MEN~SANOFI PASTEUR~UE111AA~UNK~~~MENINGOCOCCAL (MENOMUNE)~1|TD~AVENTIS PASTEUR~UE1184AA~UNK~~~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0236180	04/15/2005	MN	39.0	39		F	04/15/2005	encephalitis  chronic headache				Y				Y	N	10/28/2003	10/28/2003	0		UNK	UNK						1						1	Encephalitis; Headache	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~5447A6~2~IM~UN~HEP B (ENGERIX-B)~1	USA	Disabling	Influenza
0236183	04/17/2005	NJ	50.0	50		M	04/17/2005	Chief complaint of right arm numbness, pain, difficulty speaking, asymmetry of lips at 2:30 in the afternoon following a vaccination of Influenza and Typhoid at 11:30am.  Patient was taken to hospital by EMS.				Y					U	04/16/2005	04/17/2005	1	Unknown	MIL	MIL	Unknown	None noted	Patient is taking Tiazac, Diovan, Hydrochlorothyizide all for Blood Pressure.			1						1	Face oedema; Hypoaesthesia; Pain; Speech disorder; Coordination abnormal; Dizziness; Dysarthria; Fatigue; Injection site reaction; Malaise; Pain; Paraesthesia; Paralysis; Somnolence	FLU3~SANOFI PASTEUR~U1557AA~7+~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~SANOFI PASTEUR~X0850~4~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|TYP~UNKNOWN MANUFACTURER~~UNK~~RA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0236245	04/18/2005	MO	56.0	55		M	04/11/2005	Multiple sclerosis exacerbation secondary to Pneumovax vaccine.  As per annual follow up report: excacerbation of MS immediately after administration of Pneumovax, characterized by more dysesthesia, extreme unsteadiness in feet, difficulty with balance and weakness in legs as well as numenss and tingling.					Y	5			N	09/28/2004	10/28/2004	30	Lab test within normal limits other than elevated Glucose 200-300.	PUB	UNK	Avonex, Zanatlex, Aspirin Pepcid, Glucephage	NONE	Multiple sclerosis; Type II Diabetes; Degenerative arthritis.			1						1	Asthenia; Balance disorder; Blood glucose increased; Condition aggravated; Hypoaesthesia; Multiple sclerosis; Paraesthesia	FLU3~AVENTIS PASTEUR~61418AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0604N~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0236292	04/19/2005	NJ	66.0	65		F	12/06/2004	Pt states approximately 3 hours after receiving vaccine, developed severe diarrhea. 2 1/2 hours later developed vomiting, chills, temp and headache. Did not recover until following afternoon approx. 12 hrs later. Advised to notifiy PMD.									Y	12/04/2004	12/04/2004	0		PUB	PUB			Allergic to mold, trees, Asthma, Aortic stenosis.		NJ200402	1						1	Chills; Diarrhoea; Headache; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~0740N~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0236337	04/19/2005	PA	61.0	61		F	04/19/2005	2:30PM: while trying to park car, noted L arm wasn't working right; experienced pain over top of shoulder radiating into the rib cage. By 3:30PM, couldn't move clothing hangers on rack (shopping), fingers tingled, forearm fine motor control limited by pain;  shoulder was 'frozen' and could hardly be moved; used sling during evening; noted chills ~ 6:00 PM, fell asleep & when she woke, no longer had chills. Now has limited use of arm but improved from yesterday. Arm remains sore and cannot be lifted above shoulder height.  Is taking 800 mg ibuprofen q 6 hr, feels that symptoms (pain and limited mobility) are less today than yesterday.									U	04/18/2005	04/18/2005	0		UNK	UNK		denies				1						1	Chills; Hypokinesia; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U1532AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~SANOFI PASTEUR~X0862~3~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0236360	04/20/2005	AK	50.0			M	04/14/2005	Severe muscle and bone aches beginning about 6 hours after shot. Little or no sleep x 2 nights. Vertigo/ dizziness and ears ringing. Loss of appetite. Feel fever and chills, cannot work for 2-3 days.									Y					PUB	PUB				muscle, join aches, sleeplessness, appetite lost, fever and chills~Influenza (Seasonal) (Fluzone)~~0.00~In Patient		1						1	Anorexia; Chills; Insomnia; Myalgia; Pain; Pyrexia; Tinnitus; Vertigo	FLU3~SANOFI PASTEUR~U1377AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0236361	04/20/2005	NJ	73.0	72		F	03/30/2005	local reaction- redness, itching, swelling, hardness, afterwards area became infected due to pt scratching site.									U	01/21/2005	01/23/2005	2		PVT	PVT						1						1	Injection site infection; Injection site mass; Injection site oedema; Injection site reaction; Pruritus	FLU3~SANOFI PASTEUR~U1457AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0236373	04/20/2005	MD	70.0	70		F	04/20/2005	Patient complaining of continuous pain at injection site, progressive weakness and tremors in Left arm (vaccination site). Patient had not sought evaluation from her primary medical provider.  Advised to follow up with PMD for clinical evaluation.									N	12/06/2004	12/07/2004	1		UNK	UNK		None listed	None listed			1						1	Hemiparesis; Injection site pain; Tremor	FLU3~SANOFI PASTEUR~U1532AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0236542	04/22/2005	FL				M	04/20/2005	Pt complaining of feeling fever, weak with swollen lymph nodes. Exam revealed left occipital and submandibular node was tender. Patient was afebrile. Only treatment was Tylenol. Signs and Symptoms resolved by 02/04/2005.									Y	01/20/2005	01/30/2005	10		PUB	UNK						1						1	Asthenia; Lymphoedema; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1	USA		Influenza
0236541	04/24/2005	LA	38.0	38		M	04/24/2005	Patient was in excellent shape prior to deployment (no complaints, no medications, running a first class physical fitness test).  Patient was preparing to deploy for three months.  Patient received six vaccinations during deployment (30 Nov - PPD; 03 Dec 2004 - Yellow Fever and Smallpox (15 jabs);  14 Dec 2004- Flu and Typhoid; 16 Dec 2004- Meningococal).  On 30 December, patient began to develop neurological symptoms which were eventually diagnosed upon patient's return home as Amyotrophic Lateral Sclerosis (ALS- Lou Gehrig's Disease) on March 15, 2005.			Y					Y	N	11/30/2004	12/30/2004	30	Upon returning home, the patient underwent an EMG and Nerve Conduction Velocity test along with MRI's of the head, cervical, thoracic, and lumbar vertebrae.  Patient also had a spinal fluid draw along with many other tests to rule out all other diseases.	MIL	MIL	08 Dec 2004- Began daily dosage of malaria chemophophylaxis (doxycycline). 02 Jan - 15 Jan 2005:  As part of smoking cessation class, took Wellbutrin for about two weeks before stopping due to difficulty walking.	None.  Initial symptoms of neurological distress began with patient tripping overself and twisting right ankle while walking on level smooth surface.  Due to ankle injury and large gravel surface throughout camp, patient had difficulty identifying the fact that motor neurons were being destroyed and attributed difficulty walking to rough surface and ankle injury initially.	None.  Perfect condition prior to deployment.			1						1	Neurological symptom	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~UNK~IM~RL~MENINGOCOCCAL (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4020072~2~ID~LA~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~~UNK~IM~RA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|YF~SANOFI PASTEUR~UE017AA~UNK~IM~RA~YELLOW FEVER (YF-VAX)~1	USA	Life Threatening,Disabling	Influenza
0236553	04/25/2005	MI	45.0	45		F	04/20/2005	Received Flu vaccine at approximately 3:00 PM at clinic. Started not feeling well with Headache, fatigue, increased temperature around 9:00PM. Pt had to stay home with SX of HA, temp 99-102 degrees, pain in all joints, fatigue, felt like crap x 1 week until pt started to feel 1/2 way better									Y	01/10/2005	01/10/2005	0		PUB	UNK						1						1	Arthralgia; Body temperature increased; Fatigue; Headache; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0236592	04/25/2005	WA	71.0	71		F		Arm redness and pain, fever and diaphoresis, body aches and weakness, palpitations.										04/18/2005	04/18/2005	0	NONE	PVT	UNK		NONE	PCN and ASA allergies			1						1	Asthenia; Hyperhidrosis; Injection site erythema; Injection site pain; Myalgia; Palpitations; Pyrexia	FLU3~SANOFI PASTEUR~U1548AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~466442~UNK~~RA~PNEUMO (PREVNAR)~1|PPV~MERCK & CO. INC.~0815P~UNK~~RA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U1211DA~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0236601	04/26/2005	CT	26.0			F	03/23/2005	Warmth, Swelling, redness at site. No fevers, no signs of anaphylaxis.				Y					Y				WBC 9.8 with normal diff.	PVT	OTH	Depakote, Clozaril, Albuterol, Paxil, Topamax, Norvasc.		Panic disorder, GERD, Schizoaffective disorder, Asthma			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0236602	04/26/2005	IA		1	.4	F	04/18/2005	04/08/2005-PC from father-stated that red raised rash started earyl this morning, no fever and eating ok. Felt warm but did not check temp, playing without problems. PC to father as follow up 04/18/05 states rash increased on 04/08/05 so taken to DR in evening, ran tests related that DR did not feel that rash was related to shots. Given Benadryl x2 days and rash gone.				Y					Y	04/07/2005	04/08/2005	1		PUB	PUB						1						1	Rash erythematous	DTAP~SMITHKLINE BEECHAM~DTPA639B2~4~~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1405AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0095P~3~~LA~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~A67184E~4~~LA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0236704	04/27/2005		37.0	37		M	04/27/2005	CELLULITIS RIGHT DELTOID. LOCAL REACTION. TX. NSAIDS.									Y	04/20/2005			NONE	MIL	MIL	NONE	NONE	NONE			1						1	Cellulitis; Injection site reaction	FLU3~SANOFI PASTEUR~U1454AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0596P~1~IM~RA~HEP B (RECOMBIVAX HB)~1|MMR~MERCK & CO. INC.~0316P~1~IM~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|OPV~UNKNOWN MANUFACTURER~0555~1~IM~RA~POLIO VIRUS, ORAL (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~LA~PNEUMO (NO BRAND NAME)~1|TYP~SANOFI PASTEUR~1168AA~1~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0236765	04/29/2005	CA	73.0	73		F	01/05/2005	12/28/04-felt irritation on tongue. After lunch saw red spot in center of tongue slightly shiny and raised. Smaller than a dime. Stinging sensation. Took Benadryl 25mg. 12/29/04- saw blood on tissue than saw bright red blood in urine. --- RX for Cipro 500mg x 5 days.				Y					Y	12/28/2004	12/28/2004	0		PUB	PUB	Multivitamin, glucosamine,				CA050020	1						1	Glossitis; Glossodynia; Haematuria; Tongue discolouration	FLU3~SANOFI PASTEUR~U1519AB~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0236788	04/29/2005	OH	59.0	58		F	02/01/2005	Pt reported receiving flu shot in the afternoon an developed lower back and hip pain that evening. Denies any symptoms- no fever, local redness, cold symptoms. HA. Did fall in December. Was referred to private MD. Has had flu shots in the past with no problems.									U	01/26/2005	01/26/2005	0		PUB	PVT						1						1	Back pain; Erythema	FLU3~SANOFI PASTEUR~U1418AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0236830	05/02/2005		48.0	48		F		This is a serious post marketed study case from a physician in the USA of BELL'S PALSY considered medically important (OMIC). The reporter causality is probably related to FluMist. On 2/1/05 a 48 year old female received FluMist and on 2/4/05 the patient reported hyperhydrosis of hands. On 2/6/05 the patient developed left facial tingling for which she presented to the medicine department on 2/9/05. At the exam table, she was unable to close her eyes completely and had a left facial droop. The patient has a history of Bell's palsy since in her 20's. She also complained of hyperhydrosis of hands without relief with Drysol. The patient was treated with prednisone taper, acyclovir (400mg TID for ten days), artificial tears, and her eyes were taped shut at night. The patient completed course of treatment prescribed on approximately 2/19/05. The patient's clinical outcome was unknown.									U	02/01/2005	02/04/2005	3		PVT	OTH	NONE		Bell's Palsy since patient in her 20's.		MEDI0003232	1						1	Condition aggravated; Facial palsy; Oedema peripheral; Paraesthesia	FLUN3~MEDIMMUNE VACCINES, INC.~500334P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0236839	05/02/2005	GA	76.0	76		M	12/22/2004	Wife phoned HD 12/09/04 to report: he has a knot on his left upper arm where he got the flu shot 2 weeks ago. It has pus in it. Approximately size of a nickel. Nurse urged wife to take him to MD. He saw MD. F/u call on 12/29/04, was RX for Augmentin for 7-10 days and his arm is fine now.				Y					Y	11/24/2004	12/09/2004	15		PUB	UNK					GA04059	1						1	Bacterial infection; Injection site mass	FLU3~SANOFI PASTEUR~U1555AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0236840	05/02/2005	CA	57.0	56		M	04/26/2005	Zero adverse events- Resident psych pt. Displays numerous psychosomatic complaints. Information from missing data report states: there was no adverse effects from vaccine. Client psych pt.										01/13/2005				PVT	PVT						1						1	Neurosis; Unevaluable event	FLU3~SANOFI PASTEUR~U1504AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0236860	05/02/2005	NJ	0.83	0	.8	M	05/02/2005	Hives, for a week. Finally the doctors office had to give a steroid shot.  For the week he was given Benadryl and steroid treatment orally.  The shot was the last resort.				Y					Y	01/25/2005	01/30/2005	5		UNK	UNK						1						1	Urticaria; Faeces pale; Irritability; Somnolence; Urticaria	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~2~~~HEP B (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1463AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|HEP~MERCK & CO. INC.~0337P~2~IM~LL~HEP B (FOREIGN)~2	USA	Emergency room visit	Influenza
0236884	05/03/2005	OR	69.0	68		M	01/11/2005	Generalized rash, streaks, itching, no temp taken, no N/V, no H/A.									Y	12/22/2004	12/22/2004	0	NONE	PUB	PVT	Liptor	NONE	NONE		OR200512	1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U1419AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0236973	05/04/2005	TX	57.0	57		M	05/04/2005	The following day pt developed muscle and joint pains/aches that progressed and led to full eval and eventual diagnosis 9 weeks later of polymyalgia rheumatica with response to oral prednisone and resolution of sx. pt is still on prednisone.				Y					U	02/09/2005	02/10/2005	1	sed rate >100	MIL	OTH		none	T2DM; OSA on CPAP; obesity; GERD; HTN; hyperlipidemia; erectile dysfxn; allergic rhinitis			1						1	Arthralgia; Laboratory test abnormal; Myalgia; Polymyalgia rheumatica	FLU3~SANOFI PASTEUR~U1497AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0237055	05/05/2005	IL	50.0	49		M	05/05/2005	Soldier received vaccinations in November of 03 and reported onset of rash starting at neck in late December of 04. Rash continued to worsen over the following 16 months with the rash presenting at it's worse in Dec. 04 according to the patient. Non-pruritic and non painful. Rash is located over the entire torso accept for the palms and soles. Very minimal rash occurance to the face, with facial involvement not occuring until December of 2004. White pigmentation is present over a large majority of the skin possibly suggesting permanent scarring. Rash is raised with crusty appearance noted on some of the lesions. No other health issues have been noted by the patient. Patient reports that lesions have opened on occasion but were non draining. Was treated with topicals periodically and completed a course of Prednisone in early March 2005 with no effect noted. Has been seen by numerous specialists with no definitive diagnoses being made.				Y					N	11/10/2003	12/30/2003	50	Numberous blood tests have been performed as well as skin biopsy of lesions.	MIL	MIL	None	None	None			1						1	Rash; Rash erythematous; Skin disorder; Skin ulcer	ANTH~EMERGENT BIOSOLUTIONS~FAV080~1~IM~~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1129AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~5373A6~1~IM~~HEP B (ENGERIX-B)~1|MEN~SANOFI PASTEUR~UB493AA~1~SC~~MENINGOCOCCAL (MENOMUNE)~1|MMR~MERCK & CO. INC.~1081M~1~IM~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0237065	05/06/2005	MT	63.0	62		F	01/28/2005	12/25/04 stated she had hives starting on head and traveling down. By 25th some blistering. Client thought it may have been nuts or possibly hair dye or vaccine.									Y	12/21/2004	12/23/2004	2		PUB	PUB						1						1	Blister; Hypersensitivity; Urticaria	FLU3~SANOFI PASTEUR~U1497AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0236860	05/09/2005	NJ	0.83	0	.8	M	05/09/2005	Hives five days following the shots.  Lasted for a week and a half and finally he was given a steroid shot at the doctors office.  During the hives he was very irritable and sleepy.  He also experienced dull yellow colored stools for two weeks after the shots.				Y					U	01/25/2005	01/30/2005	5	in progess	UNK	UNK						1						2	Urticaria; Faeces pale; Irritability; Somnolence; Urticaria	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~2~~~HEP B (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1463AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|HEP~MERCK & CO. INC.~0337P~2~IM~LL~HEP B (FOREIGN)~2	USA	Emergency room visit	Influenza
0237168	05/09/2005	NJ	79.0	79		F	05/09/2005	Daughter called the county health department to report that her mother had been hospitalized with Gullian-Barre syndrome 1/13/2005 for 4 weeks, 1 week at hospital and the remainder at another hospital. Family reports that patient lost all feeling in bottom half of her body. Diagnosis was made at  hospital. Local Doctor is unsure whether the illness was Gullian-Barre.   5/27/05 Received hospital medical records for 1/14-1/19/2005. FINAL DX: general malaise; electrolyte derangement; gait disturbance Records reveal patient dizziness, weakness, difficulty walking x several mo; nausea x 1 wk; fall w/difficulty getting up.  Transferred to higher leve of care per family request.  8/23/05 Received hospital medical records for 1/19-2/2/2005. FINAL DX: peripheral neuropathy; chronic back pain; left hydronephrosis. Records reveal patient experienced fall, leg weakness & leg cramps.  Seen by PCP & dx w/hyponatremia.  Admitted to outlying hospital & transferred to higher level of care.  Neuro,Neurosurg & Uro consults done.					Y	28			Y	11/21/2004	01/13/2005	53	check with hospitals and local doctor.  Discharge summary received 08/17/05 includes lab test abnormal.  LABS:  CT brain WNL.  CT chest/abd c/w left hydronephrosis. Sodium 126(L).  Spinal MRI c/w degenerative changes.  EMG/NCS abnormal.	UNK	UNK			PMH: HTN, leg cramps			1						1	Muscle spasms; Paraesthesia	FLU3~SANOFI PASTEUR~U1579AA~2~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0232179	05/10/2005	NY	1.68	1	.7	M	02/01/2005	Flu shot received 1/08/2005 at 9:30 - 10 AM. Pt seemed okay although more tired than usual during the day. He also was ordered for erythromycin for eyes. We placed pt in bed at 9:30 PM. Checked on him at 11:30 PM (he was okay) found him at 8:30 AM. The only thing out of another day for pt was the flu shot and order for antibiotics. If a person is sick are they not to receive the flu shot?	Y	01/09/2005							N	01/08/2005	01/09/2005	1	Autopsy results pending.	PVT	UNK		Eye discharge - Doctor did not seem concerned, but ordered antibiotics anyway.	NONE			1						2	Sudden infant death syndrome; Fatigue	FLU3~SANOFI PASTEUR~U1411AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1411AA~2~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0237204	05/10/2005	SD	78.0			F	04/13/2005	Pt states she had her flu shot by the county health dept nurse in late January or early February before going on a cruise. She saw her MD 1-2 weeks after the flu shot for a check up and mentioned her bones aching but it was very mild and she was told to take Motrin. Presented to our office on 03/24/05. C/o pain and weakness proximal posterior thighs. Has trouble getting out of chair. Is ok once she starts walking. She feels problem started after she got her flu shot. 04/13/05- Talked to pt per telephone and she states her symptoms are a little bit better. All information given via telephone 04/11/05.									U					PUB	UNK	Atenolol, ASA				SD05015	1						1	Arthralgia; Muscular weakness; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0237262	05/12/2005	CA	14.0	13		F	05/04/2005	Right upper arm erythema x 5 days. Ibuprofen 400mg every 6 hrs.				Y					U	04/28/2005	05/02/2005	4	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U1559AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0706P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0237381	05/14/2005	CA	56.0	56		F	05/14/2005	THIS INCOMPOTENT, DOCTOR. NOT ONLY GAVE MY MOM, INFLUENZA. bUT GAVE HER  PNEUMOCOCCAL, AS WELL !   mY MOTHER WAS SO SICK WHEN HE GAVE HER THIS . wE WERE THERE AT THE DOCTOR BECAUSE SHE HAD A SEVERE COLD,SHE HAD TROUBLE BREATHING .hE SENT US FOR CHEST X-RAYS,AND EVEN GAVE HER A VERY STRONG ANTIBIOTIC, called,( 2pack #1).He sent her for x-rays because of the sound in her lungs.He stated she sounds like pneumonia.I FEEL,HE LITERLY KILLED MY MOTHER !!!!  HOW ARE YOU GOING TO GIVE SOME ONE NOT ONLY SICK WITH A COLD ,BUT SHE HAD CIRIOUS OF THE LIVER AND WAS VERY SICK WITH THAT AS WELL... pLEASE IF YOU CAN HELP ME ! OR KNOW SOME-ONE WHO CAN .BEFORE HE HAS THE CHANCE TO KILL SOME-ONE ELSE.. PLEASE  Thank You!  I am the pt's Daughter,I took care of her for the last 3years. She has had flu shots before but not while she was sick and never 2 vaccines in a row! She was very sick !!  Discharge Summary received stated patient experienced cyanosis, unresponsive, hypoxia, respiratory distress and melena.	Y	03/29/2005	Y	Y	Y	3			N	03/03/2005	03/05/2005	2	She had x-rays because the doctor thought she had pnemonea, But yet he still gave her a vacine?????????	UNK	UNK		She had pnemonea,she had x-rays,and was given 2pack#1...	My mom had cirosis of the liver she was so sick all the time..			1						1	Cyanosis; Dyspnoea; Hypoxia; Malaise; Melaena; Stupor	FLUX~UNKNOWN MANUFACTURER~U1449~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Results in Death	Influenza
0237404	05/17/2005	WA	0.5	0	.5	M	05/17/2005	Patient found with vomit in crib 3.5 hours after vax.  No other illness before or after.									Y	11/26/2003	11/26/2003	0		UNK	UNK		no	no			1						1	Vomiting	DTAP~SANOFI PASTEUR~c1606aa~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~u1172aa~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~ue066aa~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~495-030~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0237448	05/17/2005	CO	30.0	30		F	05/11/2005	I was given flu shot 10/09/04. Within 7 days began developing a rash within 2 weeks had leg weakness, balance issues, falling,  loss of reflexes. SS lasted 2 1/2 months, went away then returned in Feb. following removal of appendix removal. Now Dx. CIDP.   07/25/05 Neurologist's statement  GBS 'or initial episode of CIDP' ; EMG done 12/13/04 positive for diagnosis.    Notes from 03/15/05 visit includes information of pt's reporting being 'back to normal' in January, having surgery for a ruptured appendix late February and pt's perception of 'starting to go down-hill again'.  Visit of 04/19/05 includes details of exam confirming clinical symptoms with changes in vibratory sensation, continued areflexive, slowed gait.   Pt's diagnosis ws revised to CIDP and the decision to treat with IVIG is recorded.				Y	Y	10		Y	N	10/09/2004	10/15/2004	6	11/26/04 MRI-brain; MRI-spine; 12/7/04 EMG/NCV test Abnormal: showed slow response; 12/15/04 Lumbar puncture Abnormal increased protein levels; 03/21/05 Lumbar puncture Abnormal increased protein levels in CSF 121; 4/4/05 MRI-spine Normal; 4/19/05 EMG/NCV test  Abnormal showed slow response, nerve damage (results were worse than exam results on 12/7/04). Medical record states abnormal CSF: protein 121(H), glucose 69(N).  Multiple strong abnormal lab values in December include Serum IGA 1713/ EBV 5.90/ EBNA AB >5.00 /CMV 5.62/ CMV IGG positive/ ANA EIA W/Rfx IFA positive high/ cardio CRP 6.0/ Alk phos 147.  EMG did show significant changes, slowing of responses and denervation in upper and lower extremities.	OTH	PVT	Synthroid, Paxil	NONE	Hypothyroidism, mild depression Medical records state eczema.			1						1	Abdominal pain; Balance disorder; CSF test abnormal; Gait disturbance; Muscular weakness; Paraesthesia; Rash; Urinary incontinence	FLU3~SANOFI PASTEUR~U1446AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0237483	05/17/2005	VA	46.0	46		F	05/17/2005	Pt received JEV #2 and Flu Vaccination on 16May05. On morning of the 17th, pt began to feel heat to the back of right deltoid where JEV was given.  When she looked at the site saw that it was raised, itchy with minor burning sensation. No Fever or H/A, just feeling of fatigue. Site was marked 1 1/2 inch in height and diameter. Site looked like allergic reaction to bee sting. Warm to touch, no drainage. Recommended Tylenol and Benadryl. To present in Morning for follow-up.									U	05/16/2005	05/17/2005	1	none	MIL	OTH	None	No illness present	None			1						1	Fatigue; Injection site pain; Injection site swelling; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U1515AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|JEV~SANOFI PASTEUR~EJN205B~2~ID~RA~JAPANESE ENCEPHALITIS (JE-VAX)~1	USA		Influenza
0237490	05/18/2005					M		A report was received from a manf lawyer on 09May05 concerning a male vaccinee, exact age unspecified. No details were provided regarding the vaccinees medical history or concomitant medications. In Nov2003, the vaccinee received a manf influenza vaccine, no further information available. The vaccinee became ill and was diagnosed with transverse myelitis, which no claims resulted from the flu vaccination. Follow up information will be sought.														UNK	UNK	NONE				CVOX200500060	1						1	Malaise; Myelitis	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0237514	05/18/2005	MO	8.0	8		M	08/04/2005	Body temp increased (MEDI0003313 is a serious spontaneous case from a physician whose son required hospitalization for tracheitis. The reporter causality is Not related to FluMist. An 8 year old male received FluMist on 12Feb05 and on 06Mar05 the was hospitalized due to tracheitis. On 05Mar05, the pt complained of not feeling well, tired, and throat hurt. At 1:30AM on 06Mar05, the father noticed pt was awake and afebrile. At 3:30AM, he was unable to breathe and had stridor. The pt was taken to the ER on 06Mar05 and was able to breathe a bit better during the car ride. At the ER he was given breathing treatments which included steroids. A throat x-ray showed very little room to breathe for pt. He was diagnosed with tracheitis and a tracheostomy tube was inserted. Pt was taken to ICU on that Sunday 06Mar05 where he was intubated for five days. After 24 hrs in the ICU, his body temp increased and fluctuated to between 102-103.6 degrees F. His lungs were clear and he was heavily sedated with Propofol (diprivan) and Versed (midazolam). He was treated was clindamycin, to which he had an unspecified reaction and Benadryl (diphenhydramine). Throat culture during the hospital stay was positive for Influenza B. The pt was in the ICU for five days and the tracheostomy tube was removed Friday 11Mar05 after a normal x-ray finding. The pt was discharged on 11Mar05. The pt has recovered and is currently receiving daily Claritin (loratadine), Pepcid (famotidine), and Zantac (ranitidine). The reporter stated the pt is a big boy and could stand to lose some weight. He does not have any allergies nor was taking any medications prior to FluMist vaccination. The reporter does not believe tracheitis was due to FluMist vaccination.					Y	5			Y	02/12/2005	03/05/2005	21	06Mar05 x-ray: tracheitis; 11Mar05 x-ray: normal; Mar05 throat culture: positive for Influenza B.	PVT	OTH			No medications for allergies or otherwise. Received TIV (trivalent influenza virus) vaccine in the past without any problems.		MEDI0003313	1						1	Dyspnoea; Fatigue; Hypoxia; Insomnia; Malaise; Pharyngolaryngeal pain; Pyrexia; Sepsis; Stridor; Tracheitis; Viral infection	FLUN3~MEDIMMUNE VACCINES, INC.~500338P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0237518	05/18/2005	MA	50.0	50		F	05/18/2005	One week after flu vaccine, had fatigue and  sinusitis, and bronchitis. Treated with antibiotics, recovered and had recurrence of sinusitis in Feb.and bronchitis in late April. Has been in bed, off work with severe fatigue since February, 2005.				Y					N	01/15/2005	01/22/2005	7	States CDC, Mono test and lyme test WNL. ANA was borderline (150). Will get more lab tests done today. States lyme is endemic in her area and lyme test not reliable so may get treated for lyme. Had negative HIV test last year, but will get again.	UNK	UNK	Voltrex	Herpes-- on Voltrex (suppressive therapy for herpes)	Herpes			1						1	Bacterial infection; Bronchitis; Fatigue; Sinusitis	FLU3~SANOFI PASTEUR~~6~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0237577	05/19/2005	OH	21.0	21		M	05/13/2005	Developed headaches, vision loss and eye pain. 5Dec03: Received anthrax #1, Twinrix and Influenza vaccines. 13Dec03: noticed fluid filled lesion on forefoot and a similar swelling under tongue that sometimes impaired speech. 20Dec03: Developed photophobia and throbbing headaches everywhere in head. He took Tylenol, continued full duty and did not seek medical care. He had sinus congestion at the time and these symptoms were related. 22Dec03: Awakened with headache and vision loss in right eye. Experienced aching in the eyeball itself and had acute pain in right eye when moving it. Pt was went to med center on 23Dec03 and was admitted to the inpatient service for an expedited malignancy workup. Diagnosis: right subretinal growth, likely idiopathic granuloma. Work up proved negative except for evidence of old granulomatous growth found on CT of the chest. He was also evaluated in ENT and the sulingual lesion was diagnosed as a mucocele and the lesion on the foot as a ganglionic cyst. He was started on prednisone 20mg and sent on CVL. Ophthalmology expected that his eye improve enough (if not fully) such that he will be a deployable soldier in the next 6-12 months. He continued on the prednisone for 3 weeks and his right vision improved so that he could see shapes but not details or colors. He followed up regularly with providers near his home. An MRI of the brain in Jun2004 showed Patchy white matter lesions possibly demyelinating or related to Leukoencephalopathy. Daily headaches have continued until the present. There is no pattern to them and some episodes are more severe than others. In Feb05 he returned to med center for further medical evaluation. This evaluation continues to the present.					Y	3			N	12/05/2003	12/20/2003	15	24Dec03: CT chest: findings consistent with old granulomatous disease. One enlarged precarinal node is present with calcifications likely from previous granulomatous disease. No other evidence of metastatic disease is seen in the chest.  24Dec03: CT Abdomen: No specific CT evidence of lymphadenopathy or mass seen in the abdomen or pelvis.  24Dec03: Ultra Sound testicular: normal 23Dec03: CT orbits/sella/post fossa w contrast: Ill-defined subtle area of low attenuation within the posterosuperior aspect of the right globe. The extraocular compartment is normal in appearance. The differential for this finding is relatively wide but includes metastatic lesions such as from melanoma, alternatively this may represent a primary neoplastic process within the right globe. Bilateral drusen. Mucosal thickening within the left maxillary sinus with air fluid levels consistent with sinus disease.  23Dec03: CT Head: Minimal mucosal thickening within the left maxillary sinus consistent with sinus disease. No evidence of intra axial mass. Normal examination of the head.	MIL	MIL	Ibu-8 800mg	NONE	Bronchiolitis-infancy			1						1	Blindness; Cyst; Demyelination; Encephalopathy; Eye pain; Fluid retention; Granuloma; Headache; Laboratory test abnormal; Mucous membrane disorder; Photophobia; Sinus congestion; Sinusitis; Skin ulcer; Speech disorder; Tongue oedema	ANTH~EMERGENT BIOSOLUTIONS~~UNK~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~HEP A + HEP B (TWINRIX)~1	USA	Hospitalisation	Influenza
0237579	05/19/2005	CA	70.0	70		M	05/10/2005	10/23/2004: Pt received influenza vaccine, 10/24/2004- unsteady gait, left facial/ lip numbness, and numbness, and left ear pain. 10/29/2004- To ER with ataxia, Ophthalmoplegia, nausea and vomiting, hallucinations;declined neuro admit. DDX: Acute disseminating encephalomyelitis vs. paraneoplastic syndromes with CNS neoplasm. 11/01/2004-return to ER with worseninging of symptoms and admitted to neuro for presumed acute disseminenated encephalitis. Pt had multiple MRI's, treated with high dose of corticosteroids and IVIG ??, complicated by panytopenia and MRSA/pseudomonas bacteria. The pt expired on 12/13/2004. 6/7/05 Received hospital D/C summary which states admit DX: presumed ADEM (acute disseminated encephalomyelitis).  D/C DX: neuropathy of unknown origin, pancytopenia & MRSA/pseudamonas bacteremia.  PMH: HTN, CAD, s/p CABG 2003, prostate ca 2000.  MRI done 11/1 showed multiple lesions on the brainstem.  LP w/high WBC & protein.  By 11/4 MRI showed extension of the disease to involve most of the brainstem bilaterally.  Tx with high dose steroids & antibiotics.  Periods of intubation/extubation & developed aspiration pneumonia. MRI on 11/12 showed new lesions extending to the cerebellum with some improvement in the brainstem lesions.  Developed low platelet counts which prevented PEG & tracheostomy.  Tx w/IVIG, steroids & antibiotics. HIT antibody tes was + on 11/27 & started argatroban.  Stopped that when developed pancytopenia.  Became septic & blood c/s + for both MRSA & pseudamonas, acutely decompensated & expired.	Y	12/13/2004			Y	44			N	10/23/2004	10/23/2004	0	11/01/2004- MRI with multiple brainstem lesions. Lumbar puncture; with high WBC and protein with PMN and monocytes.  04/04/2004- MRI- disease extension to bilateral brainstem. 04/16/2004- New lesions to cerebellum with some resolution of brainstem lesions. PET Scan r/o lymphoma.	UNK	UNK			Allergies: NKDA; PMH: CAD s/p CABG x 4; HTN, prostate cancer, hyperlipidemia.			1						1	Bacterial infection; Bence Jones protein urine present; CSF test abnormal; Central nervous system neoplasm; Cerebrovascular disorder; Condition aggravated; Coordination abnormal; Ear pain; Encephalitis toxic; Facial neuralgia; Gait disturbance; Headache; Hypoaesthesia oral; Nausea; Nervous system disorder; Neuralgia; Neurological symptom; Nuclear magnetic resonance imaging brain abnormal; Ophthalmoplegia; Optic neuritis; Protein bound iodine increased; Skin ulcer; Viral infection; Vomiting; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~U1460AA~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0237586	05/19/2005		86.0	85		M	02/02/2005	Pt received influenza vaccine on Fri (Jan 8) and developed fluid build up in left arm, hand, and left ankle. Also had N/V and rash on arm. Reported to ER on 01/11/05. Red rash that itched. Kenalog 40mg IM given. Instructed not to ever take the flu vaccine again. No new meds started in relation to occurrence of event.									Y	01/08/2005	01/08/2005	0		UNK	UNK			Osteoarthritis, emphysema, cataract, anemia, CVA, HTN, intermittent claudication.			1						1	Fluid retention; Rash erythematous; Rash pruritic	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0237589	05/19/2005	FL	75.0	74		F	04/24/2005	See attachment				Y					N	01/28/2005	01/28/2005	0	01/28/05: flu vaccine; 01/29/05: ER; 01/31/05: ER by ambulance; 2/05: chest x-ray hosp; 04/12/05: echocardiogram; 04/19/05: blood test.	PUB	OTH		NONE	See attachment			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~V1549AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0237643	05/20/2005	CA	1.42	1	.4	M	05/20/2005	After his flu vaccine, he had stomach flu (low energy levels) etc for 10 days. He is now autistic.								Y	N	10/09/2003	10/09/2003	0	- Diagnosed as autistic on January 4, 2005. - Organic Acid Test reveals multiple gastrointestinal problems, including overgrowth of yeast, and elevated levels of kynurenic, possibly indicating an immune system abnormality.	UNK	UNK				Autism~Measles + Mumps + Rubella (no brand name)~1~1.70~In Patient		1						1	Autism; Gastrointestinal disorder; Immune system disorder; Influenza; Laboratory test abnormal; Viral infection	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0237654	05/20/2005	OH	38.0	37		F	05/17/2005	10/05/2003 admitted for UTI, 10/7/03 home (not related). 10/15/03 admitted loss of mobility, 10/23/03 home. 10/28/03 ER UTI, vomiting, home. 11/6/03 Vomiting, weakness admit, died 11/21/03.	Y	11/21/2003		Y	Y	25			N	10/01/2003	10/15/2003	14	Albumin 33.6% 1.78g/dL; Alpha 1 9.6% 0.51g/dl; Alpha 2 14.9% 0.79g/dL; Beta 11.9% 0.63g/dl; Gamma 30.0% 1.59g/dl. Subacute progressive axonal neuropathy, Guillain Barre	PVT	PUB		Seizure disorder: UTI	NKDA, MR , seizure disorder, obesity			1						1	Asthenia; Condition aggravated; Convulsion; Encephalopathy; Guillain-Barre syndrome; Hypokinesia; Laboratory test abnormal; Neuropathy; Pulmonary embolism; Urinary tract infection; Vomiting	FLU3~SANOFI PASTEUR~U1081AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0237655	05/20/2005	TX	58.0	57		M	05/16/2005	Chronic cough, hoarseness, phlegm, tinnitus, dizziness, anorexia.									N	01/29/2005	02/02/2005	4	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Anorexia; Cough; Dizziness; Dysphonia; Tinnitus	FLU3~SANOFI PASTEUR~U156188~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0237694	05/20/2005	ME	62.0	62		M	06/08/2005	Local reaction at injection site L deltoid, lymphadenopathy developed in axilla with persistent local pain.									N	02/09/2005				OTH	PUB						1						1	Injection site pain; Injection site reaction; Lymphadenopathy	FLU3~SANOFI PASTEUR~U1454AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0237779	05/23/2005		52.0			M	05/10/2005	Coughing, and Fever									U		02/10/2005			OTH	OTH						1						1	Cough; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0237790	05/23/2005	NE	1.45	1	.4	M	03/23/2005	Injection site, thigh is warm, red, hard, and swollen.				Y						11/25/2003	11/26/2003	1		OTH	OTH						1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site reaction; Injection site warmth	DTAP~UNKNOWN MANUFACTURER~~UNK~~~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~UNK~~~HIB (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0214612	05/24/2005	NY	46.0	45		M	12/23/2003	Approx 3 weeks after receiving flu vaccine. Pt began to experienced numbness and tingling in hands and feet with lack of reflex response in arms and legs. Has seen MD 3 times in last month and due to revisit this week. Still experiencing tingling/numbness and also heaviness in arms and legs. MD suspects Guillain Barre Syndrome.				Y					U	11/06/2003	11/25/2003	19	NONE	PUB	PVT	Enalapril qd	NONE	In remission from leukemia		NYS24002	1						2	Guillain-Barre syndrome; Hypoaesthesia; Hyporeflexia; Paraesthesia; Sensation of heaviness	FLU3~SANOFI PASTEUR~U1268AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0229760	05/24/2005	NY	4.0	4		M	11/22/2004	Child received flu vaccine on 11/09/2004 in AM and was sent home from preschool in afternoon because child had swollen face and low grade temp. Child had swollen face through 11/18/2004 accompanied by loss of appetite and diarrhea. No medical treatment sought.									Y	11/09/2004	11/09/2004	0	NONE	PUB	PUB	NONE	NONE	NONE		NYS24006	1						2	Anorexia; Diarrhoea; Face oedema; Pyrexia	FLU3~SANOFI PASTEUR~U1516AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0238230	05/26/2005	MA				F		I'm writing to report what occurred to me after my last flu vaccine shot. I have received the same shot before, usually at my doctor's office or a place of work. Sometime in the last few days of December 2004, I received permission to receive it from our local DPH branch. I received a flier, which noted that I received inactivated influenza vaccine 5/24/2004. Within three days of receiving the shot I became ill with progressive symptoms of a quite severe flu episode with fever, malaise, chills, aches, respiratory symptoms, etc. Although I was well before the shot, I have come to think I had the virus before the shot was administered. I would probably have expected in such case to have had a milder case of flu. I also wonder to what extent the vaccine might not have given me all my symptoms. I have consistently relied on this vaccine every year but have wondered what to do for the upcoming season. I also wonder if there might have been something wrong with the lot of the vaccine available in 2004.  Thank you for your attention to this matter.														UNK	UNK						1						1	Chills; Influenza; Malaise; Pain; Pyrexia; Respiratory disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0238279	05/26/2005	CT	80.0	80		M	05/26/2005	Facility received letter from patient in March 2005 stating that he had developed an exacerbation of Gullian Barre Syndrome as a severe reaction most likely due to the flu vaccine. Patient's initial bout of Guillian Barre Syndrom occured about March 23, 2004. Pt experienced total body paralysis and was on a ventilator for 5 days at another hospital.  On about May 20, 2004 patient had a relapse with full body paralysis again.  Pt stated he had a relapse 2 days after flu shot with weakness throughout body. On November 15, 2004, pt saw private MD and was prescribed prednisone 60mg (pt had been of prednisone) one month.  Pt continued to experience weakness. November 19, 2004 pt was admitted to another hospital. Pt received 5 days of plasma exchange and continue with prednisone. Pt has returned to his baseline prior to influenza shot.  6/24/05 Received hospital medical records of 11/19-11/24/2004. FINAL DX: chronic inflammatory demyelinating polyneuritis exacerbation Records reveal patient experienced ascending weakness, numbness in all extremities, clumsiness, sensory changes, double vision.  Similar to previous episodes of same in March & April, 2004.  Had self d/c steroids & symptoms recurred 2 da s/p flu vaccine.  Seen by PCP, restarted steroids.  Initially improved then relapsed & admitted.  Neuro consult done, areflexic.  Tx w/plasmapheresis, improved & d/c to home on continued steroids.					Y	5			Y	11/10/2004	11/15/2004	5	No relevant tests/lab data. Pt admitted and treated in another hospital.  LABS: EMG/NCS abnormal.	UNK	UNK	Simvastatin 20mg QD Lisinopril 2.5mg QD Atenolol 25mg QD ASA 81mg QD Glyburide 5mg BID Multivitamin 1 QD NTG SL PRN CP Brewers Yeast Chromium Vitamin E 400IUs QD CQ 10 QD	None	PMHX: CAD, HTN, DM type 2, CVA, hyperlipidemia, GERD, hx of skin cancer, hx of kidney stones, hx of Guillian Barre Syndrome  PMH: CIDP x 2 initially dx as GBS both preceded by viral syndromes; ICU w/intubation 1st time & tx w/plasmapheresis both times w/improvement.  s/p angioplasty, Lyme dx, GBS, Bell's palsy, Allergy: benadryl.			1						1	Asthenia; Condition aggravated; Paralysis	FLU3~SANOFI PASTEUR~U1479AA~1~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0238299	05/27/2005	NJ	10.0	9		F	05/16/2005	Information has been received from a registered nurse concerning a 15 year old white female with no allergies and no pertinent medical history who on 10/30/1998 was vaccinated with a first dose of varicella virus vaccine live.  Concomitant vaccine therapy included a first dose of influenza virus split virion 3v vaccine inactivated.  The patient had impetigo and a questionable allergy to milk at the time of vaccination.  It was noted that the patient was exposed to chickenpox at the end of May 2004.  The patient's mother called the physician's office to report that on 06/05/2004 the patient broke out in chickenpox with multiple lesions on her body.  On 06/12/2004 the patient's mother called the physician to report that it looked like bug bites and itchy lesions on her neck.  There was no fever.  On 06/14/2004 the patient's mother noted that there were over 100 lesions and that they were severe.  Unspecified medical attention was sought and no treatment was required.  No lab tests were performed.  Subsequently, the patient recovered.  No product quality complaint was involved.  No further information is expected.				Y					Y	10/30/1998	06/05/2004	2045	NONE	PVT	PVT		Impetigo	Milk Allergy		WAES0406USA01471	1						1	Drug ineffective; Infection; Skin ulcer	FLU3~SANOFI PASTEUR~0983300~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~628147/1262H~UNK~~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0238420	05/27/2005	NY	27.0	27		F	05/16/2005	Information has been received from a physician concerning a 27 year old caucasian female patient in human resources with no allergies and oral herpes who on 11/03/2003 abd 12/03/2003 was vaccinated subcutaneously in the arm with a first and second dose of varicella virus vaccine live, respectively.  Concomitant vaccination on 12/03/2003 included an intramuscular dose of influenza virus split virion 3v vaccine inactivated (Fluzone) and an intramuscular dose of hepatitis B virus vaccine rHBsAG.  Previous vaccination on 11/03/2003 included an intramuscular dose of hepatitis B virus vaccine rHBsAG.  There was no illness at the time of vaccination.  On 07/13/2004, an IgG EIA titer was 0.25.  The reporter stated that patient failed to serconvert and indicated non for adverse events.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information is not expected.				Y					U	12/03/2003	07/13/2004	223	Serum Varicella Zoster- 07/13/2004, 0.26 - normal	OTH	OTH			Herpes lesion intra-oral		WAES0407USA01463	1						1	Drug ineffective	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~~UNK~IM~~HEP B (RECOMBIVAX HB)~1|VARCEL~MERCK & CO. INC.~~2~SC~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0235898	05/31/2005	PA	76.0	75		F	05/31/2005	As leaving office experienced really bad pain all over body, not only at injection site. Felt like shot hit sciatic nerve. Balance and coordination problems experienced back in 2002 reoccurred. On 2/05 visited doctor and given Damaset but now on new pain killer because of problems with medication.				Y					N	12/17/2004	12/17/2004	0		PUB	PUB	Centroid, Transine and Nexium as needed.		Masectomy, appendix removed, hysterectomy, hemorrhoid.			1						2	Arthralgia; Pain; Gait disturbance; Myalgia	FLU3~SANOFI PASTEUR~V1561AA~UNK~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~~1~~GM~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0238592	05/31/2005	MO	23.0	23		F	05/31/2005	Patient has another small oozing blister approx. 2inch from primary site.				Y					U	05/20/2005	05/30/2005	10	none	MIL	OTH	Motrin	none	none			1						1	Injection site vesicles	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|SMALL~PFIZER\WYETH~~1~~LA~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~~UNK~~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0238599	05/31/2005	TX	67.0	66		F	05/26/2005	A 67 year old female received RSV vaccine or placebo and Influenza vaccine on 10/18/02, and 115 days later was admitted to the hospital with exacerbation of COPD, exacerbation of CHF, and cholestasis/biliary colic on 2/10/03. Signs and symptoms included shortness of breath and chest discomfort. The patient was treated with Rocephin, Zithromax, Solumedrol, Lasix, and Aldactone. The patient recovered and was discharged on 2/14/03. The patient has a history of COPD and CHF. The investigator assessed the event as possibly related to the study products. Follow up information received on 3/25/03: Hospital discharge summary for 2/10/03 to 2/14/03. The patient was admitted with the above presumptive diagnosis with the possibility of pneumonia, but review of chest x-ray revealed no acute infiltrates, but pulmonary vascular congestion was present. Her therapy consisted of balance of intravascular volume and improvement of respiratory status while reducing preload and afterload, and she produced sputum well, diuresed well, and saturations improved to a level of 92 to 94 on room air by 2/14/03. Procedures done to evaluate her ongoing abdominal pain in the light of her acute presentation with dyspnea, revealed a normal ultrasound but a severely reduced gall bladder ejection fraction. She was however tolerating normal diet and ambulation, breathing without supplemental O2, normal bladder and bowel function were present, and she was requesting discharge on 2/14/03. This was granted with instructions to restart her usual medication with the following exceptions. She was to increase her Aldactone to 50mg PO BID, she was prescribed Humibid LA BID, she was to increase Lasix to 40mg BID, and she was to decrease Covera HS to 180mg q hs. She was prescribed doxycycline 100mg BID for 10 days and advised to maintain a low fat, low sodium, no sugar, low starch diet. She was to recheck in my office in one week and call if having any problems. Manufacturer Report number 200300028 was previously reported as 2003031078. 11/03: New version created in order to perform recoding of AE following data conversion project. Unblinding information received on 5/16/05. The subject received Placebo.					Y	4			Y	10/18/2002	02/10/2003	115	Sputum culture were negative.	UNK	UNK	Zyrtec; Covera HS; Evista; Citracel D; Hydrocodone; Lasix; Aldactone; Aspirin; Ibuprofen; Neurontin; Avelox; Rocephin; Zithromax		History includes: Hypertension, CHF, Peripheral edema, COPD, Arthritis, Osteoporosis, Lumbar radiculopathy, Seasonal Pollen Allergies.		200300028	1						1	Abdominal pain; Biliary colic; Cardiac failure congestive; Chest discomfort; Cholestasis; Condition aggravated; Dyspnoea; Gallbladder disorder; Hypoxia; Lung disorder; Pneumonia; Pulmonary congestion	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|UNK~UNKNOWN MANUFACTURER~~UNK~~~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0238600	05/31/2005	TX	80.0	80		F	05/27/2005	An 80 year old female received RSV vaccine or Placebo and Influenza vaccine on 10/22/02 and 174 days later experienced Congestive Heart Failure, shortness of breath, chest discomfort, and was admitted to hospital on 4/14/03. Patient was discharged on 4/18/03. Outcome: Recovered. Follow up information received 4/28/03. The investigator assessed the event as possibly related to the study product. Follow up information received 5/6/03. Cross reference with manufacturer report 200300607. See relevant history. Follow up information received on 5/19/03. HISTORY AND PHYSICAL EXAMINATION 4/15/03. ADMISSION DATE: 4/15/03. INDICATION FOR ADMISSION: Severe weakness, shortness of breath. HISTORY OF PRESENT ILLNESS: An 80 year old white female admitted primarily because of swelling in the lower extremity, flu-like symptoms and generalized weakness Patient is extremely short of breath in the office. Chest x-ray showed questionable early congestive heart failure symptoms. Clinically the patient just feels poorly and it was felt that the patient should be admitted for further evaluation. PAST MEDICAL HISTORY: Significant for coronary artery disease, chronic obstructive pulmonary disease, asthma, and history of diverticular disease as well as stroke. Unblinding information received on 5/16/05. The subject received Non-Adjuvanted RSV vaccine.					Y	4			Y	10/22/2002	04/14/2003	174		UNK	UNK	Premarin; Nitrostat; Elavil; Lasix; Prednisone; Zestril; Singulair; Folic Acid; Vitamin C; Vitamin E; Verapamil HCL; Combivent Aero; Flovent Aero; Coumadin Tabs; Atenolol; Atarax; Vicodin; Hydrocodone		Emphysema; Asthma; Chronic Obstructive Pulmonary Disease; Pacemaker placement (1978 and 1998); Depression; Angina; Hypertension; Asthma. Patient received RSV vaccine or Placebo and Influenza vaccine on 10/22/02 and 121 days later experienced hypotension and cardiac arrhythmias and was admitted to hospital on 2/20/03. Discharged on 2/25/03. Outcome: Recovered. Follow up information received May 19, 2003. History and Physical examination 4/15/03. Past medical history: Significant for coronary artery disease chronic obstructive pulmonary disease, asthma, and history of diverticular disease as well as stroke. Previous surgery: Pacemaker placement, Hysterectomy, Vagotomy, Laminectomy, Cyst removal, Pyloroplasty, Hernia repair, Urethral growth resection, Left wrist surgery, left patella fracture. Allergies: Codeine, Tylenol, Lidocaine.		200300440	1						1	Asthenia; Cardiac failure congestive; Chest discomfort; Dyspnoea; Influenza like illness; Malaise; Oedema; Arrhythmia; Asthenia; Asthma; Cardiac failure congestive; Cerebrovascular accident; Chest pain; Diverticulitis; Dyspnoea; Fatigue; Hypotension; Malaise	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|UNK~UNKNOWN MANUFACTURER~N1002AA~UNK~IM~~VACCINE NOT SPECIFIED (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0238600	05/31/2005	TX	80.0	80		F	05/27/2005	An 80 year old female received RSV vaccine or Placebo and Influenza vaccine on Oct 22, 2002 and 121 days later experienced hypotension and cardiac arrhythmias and was admitted to hospital on Feb 20, 2003. Discharged on Feb 25, 2003. Outcome: recovered. The investigator assessed the event as possible related to the study product. This pt experienced congestive heart failure with shortness of breath and chest discomfort 174 days post vaccination and was admitted to hospital on April 14, 2003 and discharged on Apr 18, 2003. Outcome recovered. Cross reference with manf report 200300440. Follow up information received May 19, 2003. History and physical examination Apr 15, 2003. Admission date: 4/15/03. Indication for admission: severe weakness, shortness of breath. History of present illness: An 80 year old white female admitted primarily because of swelling in lower extremity, flu like symptoms and generalized weakness. Pt is extremely short of breath in the office. Chest x-ray showed questionable early congestive heart failure symptoms. Clinically the pt just feels poorly and it was felt that the pt should be admitted for further evaluation. Significant for coronary artery disease, chronic obstructive pulmonary disease, asthma, and history of diverticular disease as well as stroke. Previous surgery: pacemaker placement, hysterectomy, vagotomy, laminectomy, cyst removal, pyloroplasty, hernia repair, urethral growth resection, left wrist surgery, left patella fracture. Social history: the pt does not smoke or drink. Medication allergies: codeine, Tylenol, Lidocaine. Physical examination: vital signs: temp 99.4, pulse 116, respirations 20, blood pressure 149/95. General: this is an 80 year old white female who appears somewhat worn out and tired. HEENT: benign. Neck: supple with minimal jugular venous distention. Heart: regular rhythm and rate, no murmurs or gallops. Chest: lungs are clear. Abdomen: soft, nontender, normoactive bowel sounds. No rebound or guarding. Extremities: No clubbing, cyanosis. Pt has 2+ edema in the lower extremity and old scars in the midline abdomen as well as lower back from previous laminectomy. Impression: congestive heart failure; generalized debilitation; hypertension; coronary artery disease; history of cerebrovascular accident; diverticular disease; chronic obstructive pulmonary disease. Plan: pt admitted at this time for diuresis and monitoring of her cardiac status. The subject received Non adjuvanted RSV vaccine.					Y	5			Y	10/22/2002	02/20/2003	121		UNK	UNK	Premarin, Nitrostat, Elavil, Lasix, Prednisone, Zestril, Singulair, Folic Acid, Vitamin C, Vitamin E, Verapamil HC1, Combivent aero, Flovent aero, Coumadin, Atenolol, Atarax, Vicodin, Hydrocodone.		Emphysema, asthma, chronic obstructive pulmonary disease, pacemaker placement (1978 and 1988), depression, angina, hypertension, asthma, blood clots. Follow up information received May 19, 2003. History and physical examination Apr 15, 2003. Past medical history: Significant for coronary artery disease, chronic obstructive pulmonary disease, asthma, and history of diverticular disease as well as stroke. Previous surgery: pacemaker placement, hysterectomy, vagotomy, laminectomy, cyst removal, pyloroplasty, hernia repair, urethral growth resection, left wrist surgery, left patella fracture. Allergies: Codeine, Tylenol, Lidocaine.		200300607	1						2	Asthenia; Cardiac failure congestive; Chest discomfort; Dyspnoea; Influenza like illness; Malaise; Oedema; Arrhythmia; Asthenia; Asthma; Cardiac failure congestive; Cerebrovascular accident; Chest pain; Diverticulitis; Dyspnoea; Fatigue; Hypotension; Malaise	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|UNK~UNKNOWN MANUFACTURER~N1002AA~UNK~IM~~VACCINE NOT SPECIFIED (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0238747	06/01/2005	MA	1.26	1	.3	M	05/16/2005	Information has been received from a registered nurse concerning an approximately 16 month old male who on 10/26/2004 was vaccinated with a dose of varicella virus vaccine live.  Concomitant vaccination included the influenza virus vaccine.  Subsequently, in 2004, the patient developed a rash, erythema multiforme.  Unspecified medical attention was sought.  At the time of this report the patient's status was unknown.  No product quality complaint was involved.  Additional information has been requested.				Y					U	10/26/2004	10/26/2004	0	Unknown	OTH	OTH			Unknown		WAES0411USA01050	1						1	Rash erythematous	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~648756/0593P~UNK~~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0238845	06/01/2005	FL	68.0	67		M	05/31/2005	Additional information received on 3/18/05. A 67 year old male received RSV vaccine or placebo and Influenza vaccine on 11/7/02 and 102 days later was admitted to the hospital for chest pain. A chest x-ray revealed bronchitis and infection of the lungs per patient. ECG and catheterization was done to rule out cardiac condition. The patient was treated with Prednisone 40mg QD from 2/17/03 to 3/3/03 and Tequin 400mg from 2/17/03 to 2/29/03. The patient recovered and was discharged on 2/22/03. The investigator assessed the events as possibly related to the study products. Follow up information received 2/28/03: Patient is a pleasant 67 year old, white male with a history of chronic intermittent upper epigastric/musculoskeletal chest pain, history of emphysema/COPD, hypothyroidism, with a recent negative Cardiolite stress test and negative GI work up, who presents with upper epigastric substernal chest pressure with shortness of breath on exertion. Patient has received negative GI work up recently with negative ultrasound of the bladder and questionable ROD for esophagitis. On admission, the patient was placed on rule out myocardial infarction. Cardiology evaluation with a recommendation of cardiac catheterization  on 2/21/03 with normal coronary arteries with 60% right common iliac lesions. The cardiac cause of pain was then ruled out. During this admission, the patient was placed on Prevacid 30mg twice a day with improvement of his upper epigastric/lower sternal chest pain. Patient is waiting for an outpatient follow up with Gastroenterology for further evaluation of his atypical chest pain which could be gastrointestinal or musculoskeletal in origin. Discharge diet is cardiac diet. Activities as tolerated. Condition is stable. Follow up in 7 to 10 days. Also follow up in gastroenterology in 7 to 10 days. Additional information received on 3/18/05. Investigator reported that discharge diagnoses were considered pre-existing conditions. Also confirmed the causality as possible. Unblinding information received on 5/16/05. The subject received Non-Adjuvanted RSV vaccine.					Y	5			Y	11/07/2002	02/17/2003	102	Cardiac catheterization on 2/21/03 revealed normal coronary artery, normal left ventricular ejection fraction, 60% right common iliac lesion. Portable chest x-ray on 2/18/03 which revealed a right apical opacity, age not identified, need comparison with older radiograph or CT scan of the thorax. Sodium 137, potassium 5.2, chloride 96, CO2 33, glucose 186, BUN 36, serum creatinine 1.6, calcium 8.6, AST 38, ALT 52, White count 10, hemoglobin 13.2, hemocrit 39.5, platelets 196.	UNK	UNK	Combivent; Flovent; Levoxyl		Bronchitis/Emphysema; Hypothyroidism; Chronic intermittent upper epigastric/musculoskeletal chest pain.		C200300056	1						1	Abdominal pain upper; Arterial thrombosis; Blood calcium decreased; Blood creatinine increased; Blood glucose increased; Bronchitis; Chest pain; Condition aggravated; Dyspnoea; Infection; Laboratory test abnormal; Oesophagitis; Platelet disorder; Skin ulcer; White blood cell disorder	FLU3~SANOFI PASTEUR~U0921DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|UNK~UNKNOWN MANUFACTURER~N1002AA~UNK~IM~~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0239005	06/03/2005		0.51	0	.5	U		Seizures (1st episode) around 18 hours after shots x4 with hypotonic/hyporesponsive episodes post-ictal. Hospitalized for 3 days with negative evaluation. On day of subsequent seizures one month later.					Y	3				02/07/2005	02/08/2005	1		UNK	UNK						1						1	Convulsion; Hypotonia; Postictal state; Stupor	DTAP~GLAXOSMITHKLINE BIOLOGICALS~634B2~3~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1467AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0568P~3~IM~LL~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~A67182B~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0239601	06/03/2005		4.0			M	05/27/2005	Information has been received from a physician concerning a 4 yr old male who on 18Oct04 was vaccinated with measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  (lot 644981/1235M) in his left arm. Concomitant therapy included influenza virus vaccine (unspecified) (manf unk). On 18Oct04 the pt experienced erythema and swelling around the injection site. The erythematous area was 12cm by 10cm in size. The report indicates that the pt sought medical attention. At the time of the report, the outcome was unk. No further information is available. Additional information has been requested.									U	10/18/2004	10/18/2004	0	UNK	OTH	OTH			UNK		WAES0410USA03173	1						1	Injection site erythema; Injection site oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~1235M~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0239606	06/03/2005	CA	1.28	1	.3	M	05/27/2005	Information has been received from a physician concerning a 15 month old male, with no medical history and no allergies, who on 10/27/04 was vaccinated with a dose of MMR (lot # 0515P). Concomitant vaccines administered on the same day included varicella virus vaccine live, influenza virus split virion 3v vaccine inactivated, and HIB conjugate vaccine. On 11/1/04, the patient experienced a rash, erythema multiforme. It was reported that the rash was well appearing, not peeling, was extensive all over, and that the patient was afebrile. The patient was treated with cetirizine hydrochloride and hydroxyzine. No product quality complaint was involved. Additional information has been requested.				Y					U	10/27/2004	11/01/2004	5	Body temp afebrile.	OTH	OTH			NONE		WAES0411USA00447	1						1	Erythema multiforme; Rash	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~~UNK~~~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~~UNK~~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0239608	06/03/2005	VA	1.1	1	.1	F	05/27/2005	Initial and follow up information has been received from a physician concerning a 13 month old white female with developmental delay who on 10/12/04 was vaccinated SC in the left arm with her first dose of MMR (lot # 648473/0313P). Concomitant therapy included varicella virus vaccine live, influenza virus split virion 3v vaccine inactivated, and polymyxin B sulfate (+) trimethoprim. On 11/3/04, the patient developed acute parotitis with swelling in the left gland. The physician reported that approximately 12 days ago the patient received MMR, and that she presented with sudden onset of swelling of left cheek. It was also reported that the whole left side of her face was swollen, and that there was a firm induration and a soft, puffy area. There was no fever or change in level of consciousness. At the time of the report, the patient had not yet recovered. The physician felt that acute parotitis was related to MMR. There was no product quality complaint involved. No further information is available.				Y					N	10/12/2004	11/03/2004	22	UNK	PVT	PVT	Polytrim		Developmental delay.		WAES0411USA00726	1						1	Face oedema; Lymphadenopathy; Parotitis	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0313P~1~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~~UNK~~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0239609	06/03/2005	PA	1.3	1	.2	F	05/27/2005	Informaiton was received from an emergency medical technician (patient's mother) concerning her 15 month old daughter who on 01 NOV 2004 was vaccinated with MMR.  Concomitant therapy included a dose of PREVNAR and a dose of influenza virus vaccine.  On 01 NOV 2004 the patient developed a severe erythematous generlized rash, and fever.  It was also reported that the patient had a TB test on 01 NOV 2004.  The child was examined at the hospital but not admitted.  It was also reported that she was being treated symptomatically was recovering.  There was no product quality complaint involved.  Additional information is not expected				Y					N	11/01/2004	11/01/2004	0		OTH	OTH	tuberculin				waes0411usa02358	1						1	Erythema; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~~UNK~~~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0239622	06/03/2005	MI	1.05	1	.0	M	05/27/2005	Information has been received from a physician concerning a 12 month old white male patient with otitis media and upper respiratory tract infection who on 12/12/04 was vaccinated SC with a dose of MMR. Secondary concomitant vaccination on 12/12/04 included a dose of varicella virus vaccine live, diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid, influenza virus vaccine, HIB conjugate vaccine. Concomitant medication included prednisolone Na phosphate and budesonide. On 12/12/04, the patient experienced fever (from 101-103.7 degrees F), foam at mouth, 6 areas of redness and boil left thigh. The patient came to the office on 12/14/04 and was treated with cephalexin. On 12/17/04 the patient experienced foamy loose stool. On 12/20/04 the patient experienced roseola described as a rash all over. It was reported that the patient had recovered from the roseola, the boil, the areas of redness, the fever, and the foamy loose stools and the foaming at the mouth. Additional information is not expected.				Y					Y	12/12/2004	12/12/2004	0	Body temp 101 F and 103.7 F.	PUB	OTH	Pulmicort; Orapred		Otitis media; Upper respiratory tract infection		WAES0412USA02641	1						1	Diarrhoea; Erythema; Furuncle; Pyrexia; Roseola; Salivary hypersecretion	DTP~UNKNOWN MANUFACTURER~~UNK~~~DTP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~UNK~~~HIB (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~~UNK~~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0239627	06/03/2005	MN	1.0	1	.0	F	09/12/2005	Information has been received from a physician concerning a 12 month old female with no medical history or allergies, who on 12/31/04 was vaccinated with a 0.5ml dose of MMR (lot # 647279/0417P). Concomitant therapy included a dose of varicella virus vaccine live (lot # 646819/1065N). On 1/5/05, five days later, the patient developed a rash on her trunk and face. Unspecified medical attention was sought. A prescribed drug was required for the rash. No diagnostic studies were performed. It was reported that the patient's rash was still being treated with prescription drug treatment. No product quality complaint was involved. Additional information has been requested. Initial and follow-up information has been received from a physician and a certified medical assistant concerning a 12 month old female with no medical history or allergies, who on 31-DEC-2004 was vaccinated SC in the right lower extremity, at 3:30 pm, with a first 0.5 ml dose of MMR II (lot# 647279/0417P). On 31-DEC-2004, at 3:25 pm. the patient was also vaccinated IM in the left upper extremity with a third dose of COMVAX (lot# 648823/0240P) and vaccinated SC in the left lower extremity with the first dose of VARIVAX (lot# 646819/1065M). Other concomitant therapy included a second dose of FLUZONE (lot# U1533AA). On 06-JAN-2005, at 10:30 am, the patient developed a macular rash on her trunk and face with blanching and a fever of 101. A prescription drug was required for the rash. No diagnostic studies were performed. It was reported that the patient was treated with an unspecified prescription drug. The patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected. This is a consolidation of two reports concerning the same patient. It has been determined that WAES#0501USA02720 is a duplicate of WAES#0501USA00745. Therefore, WAES#0501USA02720 will be deleted from our files and consolidated into WAES#0501USA00745.				Y					U	12/31/2004	01/05/2005	5	body temp, 01/06/05, 101;	PVT	PVT			NONE		WAES0501USA00745	1						1	Body temperature increased; Pallor; Pyrexia; Rash; Rash macular; Pyrexia; Rash macular	FLU3~AVENTIS PASTEUR~U1533AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0240P~3~IM~LL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0417P~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1065N~1~SC~LA~VARICELLA (VARIVAX)~1|FLU3~SANOFI PASTEUR~U1533A~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|HBHEPB~MERCK & CO. INC.~648823/0240P~3~IM~UN~HIB + HEP B (COMVAX)~2|MMR~MERCK & CO. INC.~647279/0417P~1~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~2|VARCEL~MERCK & CO. INC.~646819/1065N~1~SC~UN~VARICELLA (VARIVAX)~2	USA	Emergency room visit	Influenza
0239627	06/03/2005	MN	1.03	1	.0	F	05/27/2005	Information has been received from a certified medical assistant concerning a 12 month old female who on 12/31/2004, at 3:30pm, was vaccinated subcutaneously in the right lower extremity with the first dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  On 12/31/2004, at 3:25pm, the patient was also vaccinated intramuscularly in the left upper extremity with a third dose of concomitant suspect therapy hib conj-hepatitis b vaccine, and vaccinated subcutaneously in the left lower extremity with the first doses of concomitant therapy included a second dose of influenza virus split virion 3v vaccine inactivated.  On 01/06/2005, at 10:30am, the patient developed a macular rash, with blanching and fever of 101.  Unspecified medical attention was sought.  The patient's outcome was not reported.  Additional information is not expected. This is follow-up to report (s) previously submitted on 5/27/2005. Information has been received from a certified medical assistant (CMA) concerning a 12 month ild female wo on 31-DEC-2004, at 3:30 p.m., was vaccinated SC in the right lower extremity with the first dose of MMR II (lot #647279/0417P). On 31-DEC-2004, at 3:25 p.m., the patient was also vaccinated IM in the left upper extremity with a third dose COMVAX vaccine (MSD) (lot #648823/0240P), and vaccinated SC in the left lower estremity with the first dose of VARIVAX vaccine live (Merck) (MSD) (lot # 646819/1065N). Other concomitant therapy included a second dose of FLUZONE (lot #U1533AA). On 06-JAN-2005, at 10:30 a.m., the patient developed a macular rash, with blanching and fever of 101. Unspecified medical attention was sought. The patient's outcome was not reported. Additional information is not expected. It has been determined that WAES#0501USA02720 is a duplicate of WAES#0501USA00745. Therefore, WAES#0501USA02720 will be deleted from our files and consolidated into WAES#0501USA00745.				Y					U	12/31/2004	01/06/2005	6	Body temp- 01/06/2005 - 101 degrees	PVT	PVT			None		WAES0501USA02720	1						2	Body temperature increased; Pallor; Pyrexia; Rash; Rash macular; Pyrexia; Rash macular	FLU3~AVENTIS PASTEUR~U1533AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0240P~3~IM~LL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0417P~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1065N~1~SC~LA~VARICELLA (VARIVAX)~1|FLU3~SANOFI PASTEUR~U1533A~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|HBHEPB~MERCK & CO. INC.~648823/0240P~3~IM~UN~HIB + HEP B (COMVAX)~2|MMR~MERCK & CO. INC.~647279/0417P~1~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~2|VARCEL~MERCK & CO. INC.~646819/1065N~1~SC~UN~VARICELLA (VARIVAX)~2	USA	Emergency room visit	Influenza
0239090	06/06/2005	CA	21.0	21		M	05/18/2005	Patient broke out in hives all over his body; major itching and swelling about 30-40 minutes after receiving vaccination. Discharge summary states allergic reaction, dyspnea. msv				Y	Y	1			Y	05/17/2005	05/17/2005	0	Allergic reaction to medication.	MIL	MIL	NONE	NONE	NKDA			1						1	Dyspnoea; Hypersensitivity; Pruritus; Swelling; Urticaria	FLU3~SANOFI PASTEUR~U1549AA~1~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB019BA~1~IM~LA~HEP A + HEP B (TWINRIX)~1|MEN~SANOFI PASTEUR~UE348AA~1~SC~LA~MENINGOCOCCAL (MENOMUNE)~1|MMR~MERCK & CO. INC.~0777P~UNK~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PPV~MERCK & CO. INC.~0371P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0239392	06/08/2005	VA	57.0	57		M	07/05/2005	On 11/25/04, pt woke up with diminished vision in left eye with a horizon black line in vision field. Vision has improved but not to normal. (OMIC)									N	11/05/2004	11/25/2004	20	Eval by PMD, optometrist, retinologist and neuro- optic ophthalmogist. Eye exams, visual field test and eye angiograms.	UNK	UNK	Prempro, coozar, synthyroid	NONE	Unspecified food and drug allergies			1						1	Optic neuritis; Retinitis; Visual field defect	FLU3~SANOFI PASTEUR~U1382EA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0239678	06/10/2005	OK	36.0	36		M	06/10/2005	Localized burning sensation, nausea, vomiting, headaches, insomnia, tremors, numbness on left side of head, balance. Information from 60 day follow-up report states: Currently being treated at hospital. Pt is in a study. Pt had an undetected immunoglobin A deficiency. According to immunologist. The vaccine triggered the deficiency.				Y	Y				N	02/19/2003	02/19/2003	0	Immunoglobin A deficiency Immunodeficiency (due to above) Multiple neurological manifestations suggestive of immunologic reaction to the vaccination	MIL	MIL	No other meds in evidence	Service member was in good health				1						1	Balance disorder; Burning sensation; Condition aggravated; Headache; Hypoaesthesia; Immunodeficiency; Immunoglobulins decreased; Insomnia; Nausea; Nervous system disorder; Tremor; Vomiting	ANTH~EMERGENT BIOSOLUTIONS~~1~IM~LA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~1~IM~RA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0239806	06/14/2005	ND	39.0	39		M	02/03/2005	FluMist given 28Jan05, Sat 29Jan Developed B Deep nostril pain, nasal discharge to include blood. Blisters (vesicles) appeared to lateral aspects nose (external) on Sun 29Jan05. Markedly tender. Likely nasal herpes outbreak.				Y						01/28/2005	01/29/2005	1	NONE	MIL	MIL	Flonase T spray q nostril, q day. Allegra 180mg daily	NONE	Recurrent oral cold sores (infrequent) SAR/CAR			1						1	Blister; Herpes simplex; Pain; Rhinorrhoea; Tenderness	FLUN3~MEDIMMUNE VACCINES, INC.~500356P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0239871	06/15/2005	CT	23.0	23		F	06/16/2005	Received flu shot during physical - became acutely ill within days:  Autoimmune Hepatitis.  Seen by immunologist.  Rheumatologist: presently seeing.  All labs done for physical within normal limits.  Information received from medical records state fatigue, fever.				Y				Y	N	11/15/2004	11/19/2004	4	12/03 Alkaline Phosphatose 338.  AST 99/ ALT156.  Positive ANA 1:320.  Igm 512:  Lyme positive, mono positive, EBV positive.  Abnormal immunological (numerous).  Creactive protein 1.6.  04/07/2005 - Immune Function IGA 31, IGM 70.  Information received from medical recot=rds state liver function aabnormal, phosphatase alk inc, ana, infect viral, labtest abnormal.	PVT	OTH	Orthocycline	NONE  Information received from medical records sttes urinary tract infection.	Allergic to Pediazole Codeine.  History of Mono/Lyme Disease.  IGG Subclass deficiency as a baby- resolved.			1						1	Antinuclear antibody; Blood acid phosphatase increased; Fatigue; Hepatitis; Immune system disorder; Laboratory test abnormal; Liver function test abnormal; Pyrexia; Viral infection	FLU3~SANOFI PASTEUR~U1518AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0239884	06/15/2005	WI	40.0	40		M	06/15/2005	After each shot, there were no immediate reactions as decribed in the anthrax handout.  But in late Feb 2004, a few months after receiving my sixth shot, I started to have sharp pain in the right hip but it eventually went away. At that time I considered it more related to resuming an exercise program to prepare for the fitness test.  In June 2004, pain started in the right knee which has never completely gone away.  These pains were occasional in nature and easily remedied with over the counter pain medication. In Jan 2005, I started to get random pains in my chest that were concentrated along the breast bone but radiate accross the chest and under the arm.  At that time I was deployed where an EKG was accomplished to rule out a cardiac problem.  Also at this time, the knee pain was persistent as well as occasionally the hip pain.  I was prescribed 800mg Motrin at that time which seemed to take care of the problems. In early May 2005, pain started in my neck.  It seems isolated to the top of the spine or base of the skull and never completely goes away even with 800mg of prescribed Motrin.  This was followed closely with pain in both shoulders.  On 11 May 2005, I went to Sick Call for the pains in my neck and was given 800 mg Motrin.  It did not completely eliminate the pain. On 6 June 2005, returned to clinic.  The neck pain was increasing and additional pains were developing in both wrists, both kness, both ankles, both elbows, and the pain in both shoulders was now constant.  The physician prescribed 15mg Mobic and ordered a series of blood tests.  The Mobic helps eliminate about 80% of the pains but not all of them. The pains do not seem to limit range or movement or strength, but they are always there.  Also, changing positions whether sitting, reclining, or standing of the limb does not provide releif from the pain. On 14 June 2005, I returned to clinic.  At this time, I was given a referal to Internal Medicine for a follow up.				Y					N	11/01/2003	02/15/2004	106	EKG taken Jan 2005, no signs of cardiac problems Labs taken on 6 June, results not yet available	MIL	MIL						1						1	Arthralgia; Aspartate aminotransferase increased; Chest pain; Neck pain; Pain; Shoulder pain	ANTH~EMERGENT BIOSOLUTIONS~FAV075~7+~SC~UN~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U0983AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0228488	06/16/2005	OH	0.47	0	.5	F	10/21/2004	Immunizations given in am. On pm of same day to midnight upward gaze, unresponsive to mom followed by cluster of 20 episodes of jerking in all extremities Dn myoclonic seizures.				Y	Y	2			Y	10/11/2004	10/12/2004	1	+ EEG, febule seizure vs infantile	UNK	UNK	Amoxil	Ear infection	None			1						2	Coma; Convulsion; Dyskinesia; Febrile convulsion; Gaze palsy; Myoclonus	DT~SANOFI PASTEUR~U1288AA~2~IM~LL~DT ADSORBED (NO BRAND NAME)~2|FLU3~SANOFI PASTEUR~X0706~2~SC~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|HBHEPB~MERCK & CO. INC.~0283N~2~IM~RL~HIB + HEP B (COMVAX)~2|PPV~PFIZER\WYETH~495-925~2~IM~LL~PNEUMO (PNU-IMUNE)~2	USA	Hospitalisation	Influenza
0239960	06/16/2005	OH	58.0	57		M	12/29/2004	A few days after shots, right arm became painful, then numb. Numbness continues in R index finger				Y				Y	N	05/19/2004	05/21/2004	2	E R Report - RMH	UNK	UNK	Trazadone	None	None			1						1	Hypoaesthesia; Pain	FLU3~SANOFI PASTEUR~X0707~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~UHA786A4~1~IM~RA~HEP A (HAVRIX)~1|TD~SANOFI PASTEUR~U0824AA~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1|TYP~SANOFI PASTEUR~K0481~1~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Disabling	Influenza
0239961	06/16/2005	OH	1.05	1	.1	F	12/29/2004	11/19/04 acc to mother, fever started late evening 101-102. Mild soreness, redness at injection site. No vomiting. 11/21/04 acc to mom. Fever 105 - apparent seizure - hands drew up as clams, eyes rolled, to ER - life flighted to another hospital where they gave amoxycillin and sent home for no apparent problems after shots on 12/29/04 - DTap & Hib				Y					Y	11/19/2003	11/19/2003	0	Chest X-ray - neg	UNK	UNK		No	No			1						1	Convulsion; Eye movement disorder; Injection site erythema; Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~W1002-2~3~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0105N~1~SC~LA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|PNC~PFIZER\WYETH~493-267~1~IM~LA~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0192N~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0239962	06/16/2005	OH	33.0	33		M	12/27/2004	3 days after receiving influenza vaccine had pain in hands and left knee and ankle (left). Since then has spread to all joint discomfort. Taking tylenol arthritis formula per MD. To follow-up with this or if no improvement for blood work. Family history of rheumatoid Arthritis. He has no previous symptoms 12/27 still with symptoms				Y					N	12/15/2004	12/18/2004	3	None at this point 12/27/04	UNK	UNK	Unknown	N/A	Hypertension			1						1	Arthralgia	FLU3~SANOFI PASTEUR~U1459AA~2~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0239964	06/16/2005	OH	53.0	53		F	11/15/2004	Client reports developing shingles - has not returned call to supply remaining info for this report. States she is leaving for vacation 3:00am									U	10/22/2004			?	UNK	UNK	?		Asthma			1						1	Herpes zoster	FLU3~SANOFI PASTEUR~U1442AA~1~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0239973	06/16/2005	OH	12.0	12		M	09/03/2004	Developed raised rash (? hives) on trunk and upper thighs approx 24 hrs after receiving vaccines. itching, no fever. Phoned family physician who did not elect to see him - Gave Benadryl and rash resolved within 24 hours.									Y	08/30/2004	08/31/2004	1	None	UNK	UNK	Robitussin DM	SI Uri - taking cough syrup				1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~X0800-2~4~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1070N~2~SC~LA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|TD~SANOFI PASTEUR~U1000AA~5~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0239979	06/16/2005	OH	5.0	5		F	08/26/2004	Approx. 8 hrs after receiving mom reported arm swelling and warm to touch. Mom stated her arm was twice that of it's normal size. Pt. saw NP in local area, prescribed antibiotic and antihistamine. The NP thought it was more an allergic reaction than a cellulitis.				Y					Y	08/16/2004	08/16/2004	0	N/A	UNK	UNK		None				1						1	Hypersensitivity; Injection site warmth; Swelling	DTAP~SANOFI PASTEUR~U1288AA~5~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~X0706~4~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0240031	06/17/2005	OH	5.0	5		M	06/10/2004	Onset with redness, swelling and itching on right lateral deltoid where DTaP had been given. Measured 9.5cm in diameter. Advised, ice and Tylenol. Redness began resolving on Sat. much improved by 6/15/04.									Y	06/08/2004	06/09/2004	1	None	UNK	UNK	None	None	None			1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Pruritus	DT~SANOFI PASTEUR~U1272AA~5~IM~RA~DT ADSORBED (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~X0313~4~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0276N~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0240158	06/20/2005	OH	6.0	5		F	02/06/2004	Child developed rash on neck and both arms to wrists day after shot was given (12/17/03) Mom called family Dr. who instructed to give her an antihistamine (over the counter)By next am rash was gone but child had a fever of 103 degrees - mom took child to Dr. on 12/18/03 then back to Dr. on 12/22/03 because still running temp. of 103 degrees. Dr. diagnosed child with pneumonia and treated with Zithromax and Aerosol treatment. no hospitalization required.				Y					Y	12/16/2003	12/17/2003	1	None	UNK	UNK	None	None	None			1						1	Pneumonia; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U1270AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0240162	06/20/2005	OH	5.0	4		F	01/05/2004	Eyes red and itchy - slight swelling of eyes all day.  Prescribed Tavist syrup, 2 doses; symptoms resolved completely.									Y	12/16/2003	12/16/2003	0	None	UNK	UNK	Grifulvin for Ringworm	None	PCN allergy, hayfever, asthma			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U1270AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0240171	06/20/2005	MI	52.0	51		M	06/20/2005	severe right upper extremity pain/weakness/absent reflexes, pt underwent an extensive rheumatology/vascular surgery/neurology consults with no findings on any tests whatsoever to explain his symptoms, nothing on MRI despite his swelling in arm and right chest, negative angiogram/EMG and multiple labs. Per follow up report-Patient continues to complain of right upper extremity and breast pain.  Right had slightly edematous and discolored.  Neurologist suggest idiopathic brochial plexus neuropathy, likely autoimmune mediated.									N	10/23/2003	12/17/2003	55	see above ---- GENERAL CHEMISTRY ----                                                                                 PLASMA     05/12     04/06     01/03     10/18     06/09           Reference            2005      2005      2005      2004      2004           10:51     09:22     09:15     12:30     15:06     Units    Ranges ------------------------------------------------------------------------------- GLUCOSE             165.      147.      121.               mg/dL   50-200  BUN         8. L     11.        8. L     10.               mg/dL     9-21  CREAT       .9        .9        .9       1.1               mg/dL   .8-1.5  NA                  142.      142.      142.              mmol/L   137-145  K                    4.2       4.2       4.3              mmol/L    3.6-5  CL                  106.      107.      105.              mmol/L   98-107  ECO2                 26.       29.       29.              mmol/L    22-31  CA                   8.4       8.5       8.9               mg/dL   8.4-10.2  PO4                                                        mg/dL   2.4-4.4  URIC AC                                            6.0     mg/dL   3.5-8.5  PROTEIN                        7.2                          g/dL   6.3-8.2  ALBUMIN                        3.9                          g/dL    3.9-5  SGOT                           38.                           U/L    20-57  LDH                                                          U/L   313-618  ALKPHS                         92.                           U/L   38-126  G-GTP                                                        U/L     8-78  T. BIL                          .4                         mg/dL   .2-1.3  D BILI                          .1                         mg/dL     0-.4  MG                                                         mg/dL   1.7-2.2  SGPT                           51.                           U/L    21-72  2HR PP                                                     mg/dL    -<140  CPK                                                120       U/L   55-170  CK-MB                                              1.8     ng/mL      0-6  CKMB%                                              1.5         %      0-4  AMYLASE                                                     IU/L   43-123  LIPASE                                                       U/L   23-300  THEOPHY                                                   mcg/mL     8-20  LACTATE                                                   MMOL/L   .5-2.2  Comments:    a         b         c a. SPECIMEN COLLECTED    *** For test CREAT Normals: 0.8-1.5 *** b. ~For Test: BASIC METABOLIC PANEL (BMP)   ~pre-procedure   *** For test CREAT Normals: 0.8-1.5 ***   *** For test K Normals: 3.6-5.0 *** c. Evaluation for SGOT:   FEMALES: 8-39 U/L   Evaluation for SGPT:   FEMALES: 9 - 52 U/L                                                                                 PLASMA     04/28     07/29           Reference            2004      2003           08:55     11:40     Units    Ranges ------------------------------------------------------------------------------- GLUCOSE    98.      100.     mg/dL   50-200  BUN        12.       10.     mg/dL     9-21  CREAT      1.1        .9     mg/dL   .8-1.5  NA        142.      140.    mmol/L   137-145  K          4.1       3.9    mmol/L    3.6-5  CL        106.      106.    mmol/L   98-107  ECO2       26.       28.    mmol/L    22-31  CA         8.8       8.6     mg/dL   8.4-10.2  PO4                          mg/dL   2.4-4.4  URIC AC                      mg/dL   3.5-8.5  PROTEIN    7.0       6.8      g/dL   6.3-8.2  ALBUMIN    4.3       3.7 L    g/dL    3.9-5  SGOT       30.       29.       U/L    20-57  LDH                            U/L   313-618  ALKPHS     84.       92.       U/L   38-126  G-GTP                          U/L     8-78  T. BIL      .5        .4     mg/dL   .2-1.3  D BILI      .1         0     mg/dL     0-.4  MG                           mg/dL   1.7-2.2  SGPT       39.       31.       U/L    21-72  2HR PP                       mg/dL    -<140  CPK                            U/L   55-170  CK-MB                        ng/mL      0-6  CKMB%                            %      0-4  AMYLASE                       IU/L   43-123  LIPASE                         U/L   23-300  THEOPHY                     mcg/mL     8-20  LACTATE                     MMOL/L   .5-2.2                                                                                                                                                                                             ---- LIPID PROFILE ----                                                                                 SERUM     01/03     04/28           Reference            2005      2004           09:15     08:55     Units    Ranges ------------------------------------------------------------------------------- CHOL      138.      130.     mg/dL    0-200  TRIGLYC   339. H    203.     mg/dL    0-250  HDL        27. L     32.     mg/dL    29-67  LDL         56       57.     mg/dL    0-100  VLDL       68. H     41. H   mg/dL     5-40  RISKFAC   5.11      4.09              4-6.7                                                                                                                                                                                             ---- TUMOR MARKERS ----                                                                                 SERUM     01/03     04/28           Reference            2005      2004           09:15     08:55     Units    Ranges ------------------------------------------------------------------------------- CEA-S                        ng/mL      0-3  PSA-ACC   0.23      0.29     ng/mL   0-3.99  FRPSA                        ng/mL %FRPSA                           % PAP                          ng/mL    0-2.7                                                                                                                                                                                            ---- THYROID FUNCTION ----                                                                                 SERUM     04/06     07/29           Reference            2005      2003           09:22     11:40     Units    Ranges -------------------------------------------------------------------------------  TSH      1.28      1.61    uIU/mL   .49-4.67  FR T-4    1.08      0.97     ng/dl   .71-1.85  Comments:    a a. *** For test FR T-4 Normals: 0.71-1.85 ***   *** For test  TSH Normals: 0.49-4.67 ***                                                                                                                                                                                         ---- METABOLIC FUNCTIONS ----                                                                                 SERUM     04/06     07/29           Reference            2005      2003           09:22     11:40     Units    Ranges ------------------------------------------------------------------------------- FERRIT   169.5               ng/mL   23.9-336.2  B12        350       305     pg/mL   180-914  FOLATE   10.75      7.26     ng/mL     > 3.0 Comments:    a a. Evaluation for FOLATE:   New Reference Range beginning 6/18/05:  Folate > 5.0 ng/mL   Previous Reference Range (before 6/18/05): Folate > 3.0 ng/mL   Reference Range: Folate >3.0 ng/mL                                                                                                                                                                                                 ---- A1C ----                                                                                 BLOOD     01/03     10/18     04/28     12/17     07/29           Reference            2005      2004      2004      2003      2003           09:15     12:30     08:55     10:58     11:40     Units    Ranges ------------------------------------------------------------------------------- A1C-VAR    7.8 H     7.6 H     6.7 H     7.3 H     6.6 H       %   4.4-6.4                                                                                                                                                                                           ---- CBC AND AUTO DIFF ----                                                                                 BLOOD     04/06     01/03     04/28     01/05           Reference            2005      2005      2004      2004           09:22     09:15     08:55     14:22     Units    Ranges ------------------------------------------------------------------------------- WBC        6.3       5.8       6.3       5.6     K/mcL   4.8-10.8  RBC       4.93      4.84      4.80      4.76     M/mcL   4.7-6.1  HGB       14.9      14.7      14.7      14.4      g/dL    14-18  HCT       43.6      42.5      42.2      42.0        %     42-52  MCV       88.5      87.8      87.8      88.4        fL    80-94  MCH       30.1      30.3      30.6      30.2        pg    27-31  MCHC      34.1      34.5      34.9      34.2      g/dL    32-36  RDW       12.9      12.4      12.6      12.6        %    11.5-14.5  PLT        227       173       196       245     K/mcL   130-400  MPV        6.8 L     7.7       7.6       7.0 L      fL   7.4-10.4  NEUT %    67.5      64.2      62.8      62.3         %   42.2-75.2  LYMPH %   24.5      26.9      27.3      31.3        %    20.5-51.1  MONO %     5.8       6.4       6.2       4.3        %    1.7-9.3  EOSIN %    1.8       2.2       3.4       1.7         %      0-4  BASO %     0.4       0.3       0.3       0.4         %      0-2  NEUT #     4.2       3.7       3.9       3.5     K/mcL    2-8.1  LYMPH #    1.5       1.6       1.7       1.7     K/mcL   1.2-3.4  MONO #     0.4       0.4       0.4       0.2     K/mcL   .11-.59  EOSIN #    0.1       0.1       0.2       0.1     K/mcL     0-.7  BASO #     0.0       0.0       0.0       0.0     K/mcL     0-.2  Comments:    a         b         c         d a. *** For test MCH Normals: 27.0-31.0 ***   *** For test EOSIN # Normals: 0.0-0.7 ***   *** For test BASO # Normals: 0.0-0.2 ***   *** For test EOSIN % Normals: 0.0-4.0 ***   *** For test BASO % Normals: 0.0-2.0 ***   *** For test NEUT # Normals: 2.0-8.1 *** b. *** For test WBC Units: K/CUMM ***   *** For test RBC Units: M/CUMM ***   *** For test HGB Units: GM/DL ***   *** For test MCV Units: CUMM ***   *** For test MCH Units: UUG ***   *** For test MCHC Units: %  ***   *** For test PLT Units: K/CUMM ***   *** For test MPV Units: mu3 ***   *** For test MONO # Units: K/CUMM ***   *** For test LYMPH # Units: K/CUMM ***   *** For test EOSIN # Units: K/CUMM ***   *** For test BASO # Units: K/CUMM ***   *** For test NEUT # Units: K/CUMM *** c. *** For test WBC Units: K/CUMM ***   *** For test RBC Units: M/CUMM ***   *** For test HGB Units: GM/DL ***   *** For test MCV Units: CUMM ***   *** For test MCH Units: UUG ***   *** For test MCHC Units: %  ***   *** For test PLT Units: K/CUMM ***   *** For test MPV Units: mu3 ***   *** For test MONO # Units: K/CUMM ***   *** For test LYMPH # Units: K/CUMM ***   *** For test EOSIN # Units: K/CUMM ***   *** For test BASO # Units: K/CUMM ***   *** For test NEUT # Units: K/CUMM *** d. *** For test WBC Units: K/CUMM ***   *** For test RBC Units: M/CUMM ***   *** For test HGB Units: GM/DL ***   *** For test MCV Units: CUMM ***   *** For test MCH Units: UUG ***   *** For test MCHC Units: %  ***   *** For test PLT Units: K/CUMM ***   *** For test MPV Units: mu3 ***   *** For test MONO # Units: K/CUMM ***   *** For test LYMPH # Units: K/CUMM ***   *** For test EOSIN # Units: K/CUMM ***   *** For test BASO # Units: K/CUMM ***   *** For test NEUT # Units: K/CUMM ***                                                                                                                                                                                              ---- RETIC/ESR ----                                                                                 BLOOD     04/06     09/08     06/09     01/05           Reference            2005      2004      2004      2004           09:22     13:27     15:06     14:22     Units    Ranges ------------------------------------------------------------------------------- RETIC      2.0                                      %      .2-3  SEDRATE               14        21 H      13     MM/HR     0-15  Comments:              a a. Evaluation for SEDRATE:   REFERENCE RANGE = 0 - 20 MM/HR  FOR FEMALES                                                                                                                                                                                          ---- URINE CHEMISTRIES ----                                                                                 URINE     01/03     09/08     04/28           Reference            2005      2004      2004           09:15     14:01     08:55     Units    Ranges ------------------------------------------------------------------------------- COLOR  LT.YELLOW LT.YELLOW LT.YELLOW APPEARA  CLEAR     CLEAR     CLEAR SP.GRAV<=1.005 L   1.010     1.010             1.010-1.030  PH         7.0       6.5       7.0              4-8.5  UR GLU     NEG       100       NEG     mg/dL      Neg. UR KETO    NEG       NEG       NEG     mg/dL      Neg. UR. BLD    NEG       NEG       NEG                Neg. UR PROT    NEG       NEG       NEG     mg/dL      Neg. UR BILI    NEG       NEG       NEG                Neg. UROBILI    0.2       0.2       0.2     EU/dL   0.1-1.0  UR NITR    NEG       NEG       NEG                Neg. LEU ASE    NEG       NEG       NEG                Neg. Comments:    a                   b a. MICROSCOPIC NOT DONE DUE TO NEGATIVE DIPSTICK  b. MICROSCOPIC NOT DONE DUE TO NEGATIVE DIPSTICK    *** For test SP.GRAV Normals: 1.01-1.03 ***   *** For test UROBILI Normals: .1-1 ***   *** For test LEU ASE Normals: - ***                                                                                                                                                                                          ---- URINE MICROSCOPIC ----                                                                                 URINE     09/08           Reference            2004           14:01     Units    Ranges ------------------------------------------------------------------------------- WBC/HPF             /HPF      0-5  RBC/HPF             /HPF EPITH C    FEW      /LPF UR.BACT             /HPF YEAST               /HPF TRCMOND             /HPF HYALINE             /LPF GRANULA             /LPF WBC/CAS             /LPF RBC/CAS             /LPF WAXY/CA             /LPF FATTY/C             /LPF AM URAT             /HPF AM PHOS             /HPF TRI PHO             /HPF CA++ OX             /HPF URIC AC             /HPF CYSTINE             /HPF LEUCINE             /HPF TYROSIN             /HPF RE.EPTH             /HPF TR.EPTH             /HPF SQ.EPTH             /HPF                                                                                                                                                                                             ---- MICROALBUMIN ----                                                                                 URINE     01/03     04/28           Reference            2005      2004           09:15     08:55     Units    Ranges ------------------------------------------------------------------------------- MICAL   31-300 H*   >300 H*   mg/g   See Comment Comments:    a         b a. Evaluation for MICAL:   Normal: <30 mg/g   Abnormal: 31-300 mg/g   High Abnormal: >300 mg/g b. *** For test MICAL Normals: - ***                                                                                                                                                                                         ---- MISCELLANEOUS TESTS ----                                                                                    DATE    TIME   SPECIMEN          TEST         VALUE         Ref ranges ------------------------------------------------------------------------------- 04/06/2005 09:22  SERUM             TIBC:        368   mcg/dL     250-450 04/06/2005 09:22  SERUM             FE:          57   mcg/dL      49-181 04/06/2005 09:22  SERUM             FE SAT:      16. L  %         20-55 06/09/2004 15:06  BLOOD             TOT PRO:     6.6   g/dL       6-8.5 06/09/2004 15:06  BLOOD             ALB,EL:      4.0   g/dL       3.2-5.6 06/09/2004 15:06  BLOOD             ALPHA-1:     0.3   g/dL       .1-.4 06/09/2004 15:06  BLOOD             ALPHA-2:     0.7   g/dL       .4-1.2 06/09/2004 15:06  BLOOD             BETA,EL:     0.9   g/dL       .6-1.3 06/09/2004 15:06  BLOOD             GAMMA:       0.8   g/dL       .5-1.6  INTERPRETATION: The SPE pattern appears essentially unremarkable.  Evidence of monoclonal protein is not apparent.  06/09/2004 15:06  BLOOD             ANA:         NEGATIVE         NEG- 06/09/2004 15:06  SERUM             PROL:        4.6   ng/mL      2.64-13.13 06/09/2004 15:06  SERUM             ALDOLAS:     5.1   U/L        1.2-7.6 06/09/2004 15:06  SERUM             MYOGL-S:     28   ng/mL       0-50 06/09/2004 15:06  SERUM             CRP-QNT:     4.3   mg/L       0-4.9 Test(s) performed at Lab Corp Reference Laboratory.  01/05/2004 14:22  SERUM             ASO-TIT:     51.7   IU/mL     0-200   ===============================================================================	UNK	UNK	Outpatient Medications                                 Status ========================================================================= 1)   ACCU-CHEK COMFORT CURVE-H TEST STRIP USE 1 TEST STRIP  ACTIVE        AS DIRECTED 2)   ALCOHOL PREP	none	none			1						1	Abdominal pain upper; Asthenia; Hyporeflexia; Immune system disorder; Laboratory test abnormal; Oedema; Pain; Radiculitis brachial; Skin discolouration; Swelling; Asthenia; Bursitis; Feeling hot; Hyporeflexia; Injection site pain; Muscle twitching; Oedema; Osteoporosis; Pain; Pyrexia; Sensory disturbance; Tenderness; Tendonitis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1139AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0228786	06/23/2005	TX	0.51	0	.5	M	06/16/2005	This case was reported by a physician and described the occurrence of a possible anaphylactic reaction in a 6 month old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The pt's medical history was notable for breast feeding (during the month of Sep 2004). On 28Sep04, the pt received the third dose of Infanrix (lot DTPA6339B2). On 28Sep04, the pt also received injections of 7-valent pneumococcal conjugate vaccine (Prevnar) and influenza virus vaccine (Fluzone; cultures grown in fertilized chicken eggs). Approx two hrs after the administration of Infanrix on 28Sep04, the pt experienced a possible anaphylactic reaction characterized as facial swelling and urticaria. The pt was seen at a physician's office. The anaphylactic reaction was considered life threatening and required clinical intervention. The pt was treated with Benadryl and Elidel. The event resolved on 28Sep04. The physician also reported that, on 28Sep04, the pt's mom was eating eggs. The pt was subsequently found to have class 4 reaction to egg white and egg yolk. The reporting physician considered the anaphylactic reaction to possibly be related to vaccination with Infanrix.			Y	Y					Y	09/28/2004	09/28/2004	0	Allergy testing, date not specified: class 4 reaction to egg white and egg yolk.	PVT	PVT		UNK	The pt's concurrent conditions and concurrent medications were not reported.		A0529487A	1						2	Anaphylactic reaction; Face oedema; Hypersensitivity; Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~639B2~3~~~DTAP (INFANRIX)~2|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PNC~PFIZER\WYETH~~UNK~~~PNEUMO (PREVNAR)~2	USA	Life Threatening	Influenza
0240527	06/23/2005	FL	1.5			M	06/16/2005	This case was reported by a physician and described an 18 month old male pt who inadvertently received separate injections of diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated polio virus vaccine combined (Pediarix) and diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) on the same day. On 10/1/04, the pt received the 3rd dose of Pediarix. On 10/1/04, the pt also received an injection of Fluzone and Prevnar. Later that day, the pt experienced soreness at an unspecified injection site. The physician reported that no intervention was required and the pt was instructed to take ibuprofen and acetaminophen as needed to relieve soreness. Approximately 3 days later, on 10/4/04, the injection site soreness had resolved. In the physician's opinion, the soreness at an unspecified injection site was related to the erroneous administration of Infanrix.									U	10/01/2004	10/01/2004	0	UNK	PVT	PVT		UNK	The pt's medical history, concurrent conditions and medications were not reported.		A0529286A	1						1	Injection site pain; Injection site reaction	DTAP~GLAXOSMITHKLINE BIOLOGICALS~~4~~~DTAP (INFANRIX)~1|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~~3~~~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~~UNK~IM~~PNEUMO (PREVNAR)~1	USA		Influenza
0236183	06/27/2005	NJ	50.0	50		M	06/27/2005	Immunization: Typhoid and Influenza Vaccination Vaccine Date: 16 April 2004 Onset date: 16 April 2004 Symptoms: woozy, lightheadedness, extreme fatigue-sleepiness, malaise, right arm/hand pain, tingling, slurred speech 30-60 minutes following vaccination. Worse 2 hours later requiring ER visit.  History of Present Illness:    This healthy 50 year-old was revaccinated with the Typhoid vaccination to his right arm and the Influenza vaccination to his left arm on 16 April 2005 at 1130 hours.  He reports the typhoid shot really hurt and burned with right hand/thumb pain.  Within 30-60 minutes post vaccination he began to not feel well as if he were drunk feeling woozy, lightheaded with slurred speech (he did not think his words were coherent), difficulty in word enunciation and with extreme fatigue-malaise. These symptoms began while sitting at his desk completing taxes. He was told by his friends his smile was asymmetrical; yet he attributed this to a hap hearted effort due to feeling bad. He returned to the immunization clinic at 1430 hours and was seen MD.  She reported left side facial paralysis, lightheadedness and right arm pain without CNS deficits. He was transferred to Hospital for possible stroke. He describes his lightheadedness as the need to sit because he felt too uneasy on his feet.  There was no room spinning, blurry vision or headaches; however there was a sensation of falling when walking from transport stretcher to hospital bed. He described this sensation as a fullness as if he had water in his ears and being extremely tired and uneasy. He reports eating only a candy bar with a bottle of water that morning. He also reports his job keeps him walking with no change in his routine. The weather conditions were hot and muggy in the 80's. The ER physician treated him for a reaction to typhoid vaccination giving IV fluids and sent him home for 36 hours.  He was reseen by MD on Monday in the clinic. (NEED MEDICAL RECORDS).  Follow up care 20 April 2005 reported him feeling normal, looking better, feeling stronger, and less fatigued as he resumed normal activities of daily living.				Y	Y				Y	04/16/2005	04/16/2005	0	pending not available (lab, ekg, CT x-ray) stroke evaluation	MIL	MIL	Prescribed: HTN: Tiazac (Cardizem) 360 mg daily; alternates Diovan and Diovan HCT every other day. OTC: Centrum prn daily Complementary and alternative: None.	Denies	1. Hypertension age 19. 2. Ureter restriction age 6 repaired. 3. Dislocated left shoulder.			1						2	Face oedema; Hypoaesthesia; Pain; Speech disorder; Coordination abnormal; Dizziness; Dysarthria; Fatigue; Injection site reaction; Malaise; Pain; Paraesthesia; Paralysis; Somnolence	FLU3~SANOFI PASTEUR~U1557AA~7+~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~SANOFI PASTEUR~X0850~4~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|TYP~UNKNOWN MANUFACTURER~~UNK~~RA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0240712	06/27/2005	CA	20.0	20		M	06/27/2005	HIGH FEVER, RASHES (HIVES) UPPER AND LOWER EXTREMETIES WARM TO THE TOUCH AND DEEP RED COLOR, UNUSUAL SHORTNESS OF BREATH DURING LIGHT EXERCISES SUCH AS SIT UPS AND PUSH UPS-PATIENT DENIES.									Y	06/22/2005				MIL	MIL	NKDA	NONE	NONE			1						1	Dyspnoea; Erythema; Feeling hot; Pyrexia; Rash; Urticaria	FLU3~SANOFI PASTEUR~U1555AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABA016AB~UNK~IM~LA~HEP A + HEP B (TWINRIX)~1|IPV~UNKNOWN MANUFACTURER~Y0324~UNK~IM~RA~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MEN~SANOFI PASTEUR~UE495AA~UNK~SC~LA~MENINGOCOCCAL (MENOMUNE)~1|VARCEL~MERCK & CO. INC.~0081P~UNK~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0240718	06/27/2005	IN	42.0	42		M	06/27/2005	Flu Vaccine administered on 11/12/2002 at place of employment. Chronic Daily Headaches started 11/16/2002. Chronic Pansinusitus. Per follow up 9/20/05 Chronic daily headaches.				Y	Y	3		Y	N	11/12/2002	11/16/2002	4	Nuemerous MRI's, MRA, MRV, neumerous CT Scans, blood tests, Lumbar puntures,	UNK	UNK	none	none	none			1						1	Headache; Sinusitis	FLU3~EVANS VACCINES~E31882GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0240719	06/27/2005	TX	31.0	31		F	06/27/2005	Pt developed a spontaneous spinal leak of CSF at the upper thoracic area approximately 19 months ago. Although she has not been headache free since April 2003, and she has had multiple exacerbations and moderations of symptoms, she has recently been able to function in her professional role. She notes that frequently if she gets a cough or a cold she will find that the illness aggravates and irritates her spinal symptoms. In an effort to protect herself from the thoracic strain that would result if she were to contract influenza, and because she is an active pediatrician with probable exposure, she received an influenza immunization with Fluzone on November 5, 2004. Seven days later she awoke in her usual state of health, and then at 9am experienced a sudden worsening of squeezing facial pain, much more severe than in months, with reappearance in cervical and thoracic areas of bone pain, as well as a deeper pain between her shoulder blades. She had not coughed or done any activities that might have caused a new leak.				Y					N	11/05/2004	11/12/2004	7	7 Jan 2005 CT c-spine w/0 contrast - 1.)no evidence of spinal CSF leak, 2.)stable L5 Pars  interarticularis defects ANA Neg 11/19/2004 RF 11/23/04:2.4(0-16.0), 1/5/2004:1.3(0-16), 5/12/2003:0.7 (NOTE: increasing over time, but still not elevated) 11/19/2004---- Albumin 4.8(3.0-4.6) C-reactive protein <0.3 (0-1.0) Ca 9.4(8.0-10.8) CO2 22 (22-32) Cl 106(95-110) Creat 1.0(0.7-1.5) Glomerular filtrate rate-blk 85.2 (>90)* Glomerular filtrate rate-nblk 72.2(>90)* Glucose 199(70-115) Icteric index 1(0-15) Ig A 154.0(73-358)[1/8/2004:207] Ig G 933.0(649-1634)[1/8/2004:975.0] Ig M 195.0(53-251)[1/8/2004:228.0] Lipemia Index 4 (0-50)[1/8/ Phos 3.6(2.5-5.0) K 3.9(3.5-5.3) Na 141(135-150) BUN 12(5-22) Abs Baso 0.02(0-0.2) Abs Eosin 0.05(0-0.45) Abs Lymphs 1.6(1.0-4.8) Abs Mono 0.3(0-0.8) Abs neutro 3.6(1.8-7.7) Baso 0.3(0-0.6) Eosin 0.8(0-0.32) ESR 10(0-15) HCT 41.7(36-46) Hgb 14.6(12.0-16.0) Lymphs 29.0(22-44) MCH 32.1(26-34) MCHC 35.1(31-36) MCV 91.4(80-100) Neut 65.4(36-66) Platelets 264(150-400) RBC 4.56(4.0-5.2) RCDW 12.8 (11.5-14.5) WBC 5.4(4.3-10.0)	MIL	OTH			Previous spontaneous spinal leak March 2003			1						1	Bone pain; CSF test abnormal; Condition aggravated; Laboratory test abnormal; Pain	FLU3~SANOFI PASTEUR~~UNK~SC~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0240808	06/29/2005	OH	48.0	48		F	06/16/2005	Started with numbness in left cheek, tingling in arms and legs. 10 months later had the same symptoms lasting for 2 weeks. I am currently having the same symptoms again. Also tingling around lips.				Y					U	12/17/2003	12/17/2003	0		PUB	OTH		NONE	Seasonal allergies, asthma	flu-like symptoms~Tetanus Toxoid (no brand name)~~0.00~Patient		1						1	Hypoaesthesia; Paraesthesia	FLUX~SANOFI PASTEUR~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0240950	07/05/2005	AZ	81.0	81		M	07/01/2005	From initial information received on 09Feb05 from the pt's wife regarding an adverse event occurring, it was reported that an 81 yr old male pt received a dose of Fluzone SV 2004-2005USP, lot U1504AA, with the expiration date of 30Jun05, admin in the left deltoid on 26Oct04 at a pharmacy clinic. The route of admin was not reported. Five days later, the pt experienced severe pain in his legs and groin area. Subsequently, the pt gradually spread over his entire body. In addition, the pt developed nausea and an equilibrium disorder. Per the reporter, the pt now comes and goes and is less severe. The pt was seen by a general practitioner, then referred to a neurologist. Reportedly, the pt received a flu vaccine annually. He did not recover from these events. From additional information received on 10Feb05 the reporter forwarded the report she submitted online which included the information that the pt had confusion and was unable to walk and was losing weight. He also had a chest x-ray which was normal and an MRI and EMG, results not reported. From additional information received on 22Jun05 and 27Jun05 from the pt's wife, copies of clinical notes from visits with physicians were provided. The pt was seen by a physician on 24Jan05 with a complaint of generalized weakness. He had received the influenza vaccine on 26Oct04 and about one week later felt dumpy. He experienced pain and weakness in his lower extremities. In the mornings he has felt sick to his stomach. He has decreased ambition, feels pooped out, has significant postural lightheadedness and has been more confused since Christmas.  The pt was seen by a physician on 24Jan05 with a complaint of generalized weakness. He had received the influenza vaccine on 26Oct04 and about one week later felt dumpy. He experienced pain and weakness in his lower extremities. In the mornings he has felt sick to his stomach. He has decreased ambition, feels pooped out, has significant postural lightheadedness and has been more confused since Christmas. The pt describes his mood as being down and as having a poor appetite. The pt has difficulties with sleep and fatigue and some difficulties with balance which is associated with postural lightheadedness. The pt reports nausea and gastroesophageal reflux disease, nocturia and feeling depressed and anxious. A neurological examination was unremarkable except for some end gaze nystagmus, which was more prominent when the pt looked to the right. The pt was seen again by a physician on 16Feb05 and reported that he is feeling about 50% better compared to the beginning of the events. At that time he still had pain in his muscles, mostly the leg muscles and the buttock area. He cannot walk for a long time because of the fatigue and muscle aches. At times when he has lost his balance, he has fallen. He denied fever, chills, dysuria and diarrhea. He had complained of headaches for approx one week and has had some constipation. Additionally, he reported that his joints were achy in the left, thigh and buttock area. Physical examination was unremarkable and the pt was fully alert and oriented in no apparent distress. A neurological  examination was without lateralizing signs or signs of meningeal irritation. Per an infectious disease physician, the events could be related to the vaccine or the pt might have acquired a viral illness with viral labyrinthitis. The pt is gradually improving and the physician recommended continued observation of the pt's symptoms. In addition, due to the family history of lupus, it was recommended to investigate the possibility of connective tissue disease. As of Feb 2005, the pt was gaining strength and seems to be on the mend. This incident was reported on 10Jan05. The pt's wife had also informed the local dept of health. At the time of this report, the pt has not recovered from these events. Based upon medical judgement this case is being upgraded to serious.				Y					N	10/26/2004	10/31/2004	5	A CT scan, EKG and CBC were obtained and were all normal. This pt also had an MRI and an EMG, results not reported. From additional information received on 22Jun05: The pt scored a 27 out of 28 on the Kokmen short test of mental status. A cranial nerve examination was notable for some end gaze nystagmus which was more prominent when looking to the right. An MRI scan of the brain performed on 17Jan05 was notable only for some mild generalized atrophy. An EMG and nerve conduction studies were performed on 18Jan05 and showed no evidence of a myopathy or poly radicular neuropathy. Repetitive stimulation was done and there was no evidence of a disorder of neuromuscular transmission. Lab dated 11Feb05: White count was 9000, creatinine 1.1, bilirubin 1.1, ALT 20, AST 27. Sedimentation rate was 16. Urine was clear. From additional information received on 27Jun05: 06Jan05: CT of the head with and without contrast. Multiplanar pre- and post contrast brain CT. Findings: Mild prominence of both the ventricles and sulci, compatible with volume loss and age. Volume loss and small vessel ischemic change consistent with age. 06Jan05: CT of the abdomen and pelvis. Abdomen findings: 4.0cm mid to distal abdominal aortic aneurysm and smaller 1.7cm right common artery aneurysm. Moderate hiatal hernia. Small gallstones. Neg for inflammation about the gallbladder. Pelvis findings: 2.2cm aneurysm, moderate sized, near the distal right common femoral artery. The distribution is slightly unusual it terms of location at the inferior margin of the right common femoral artery. Correlation with a CTA of the extremities would be recommended to further define, as the native vessel has a diameter of 9.0mm. Sigmoid diverticulosis. No evidence of inflammation. 17Jan05: MRI Brain without MCH. Findings: There are scattered areas of increased signal on FLAIR and T2 weighted images in the periventricular white matter. There isage appropriate cerebral atrophy. Otherwise, no significant abnormality is seen. The extracranial structures imaged are unremarkable.	OTH	UNK	Lisinopril		The pt has a history of high blood pressure. He also has penicillin allergy. He did not have any illness at the time of vaccination. From additional information received on 22Jun05 it was reported that the pt has a past medical history of hypertension and lung hemorrhage. He has had eye surgery for glaucoma and a cataract. He has a history of remote tobacco use and previously drank one glass of wine a day. His family history consists of his father having heart disease, his mother having lupus and his daughter having lupus arthritis.		200500350	1						1	Aneurysm; Anxiety; Arthralgia; Asthenia; Balance disorder; Cerebral atrophy; Cholelithiasis; Confusional state; Connective tissue disorder; Constipation; Decreased appetite; Depression; Diverticulitis; Dizziness; Fall; Fatigue; Gait disturbance; Gastrooesophageal reflux disease; Gaze palsy; Groin pain; Headache; Hernia; Hypokinesia; Labyrinthitis; Myalgia; Nausea; Nocturia; Nystagmus; Sleep disorder; Viral infection; Weight decreased	FLU3~SANOFI PASTEUR~U1504AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0240968	07/05/2005	MD	34.0	33		F	06/30/2005	Within 1-2 hrs after taking the flu vaccine in 2002, pt experienced diaphoresis and tachycardia; felt like she was going to pass out. Later, she experienced abdominal cramping and diarrhea. (similar GI symptoms after eating buckwheat pancakes a year ago).									Y	11/18/2002	11/18/2002	0		MIL	MIL	Flonase, Allegra, Desogen	NONE				1						1	Abdominal pain; Diarrhoea; Dizziness; Gastrointestinal disorder; Hyperhidrosis; Tachycardia	FLU3~SANOFI PASTEUR~U0674AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229665	07/08/2005	SC	38.0	37		F	07/01/2005	I suddenly became sick immediately after receiving the flu shot at work.  I had all the symptoms of Guillian Barre Syndrome except paralysis.  Then symptoms proved to be Fibromyalgia.  Lost my job!!								Y	N	10/15/2004	10/15/2004	0	C-Reactive protein 24 times the normal values, brain scan, blood tests $5,000 later, diagnosed with Fibromyalgia.	UNK	UNK			Inhalent Allergies			1						2	Fibromyalgia; Laboratory test abnormal	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Disabling	Influenza
0241149	07/11/2005	WI	78.0	77		F	07/08/2005	An initial report was received from another manf on 06Jul05. Manf had received an initial and follow up report from a licensed practical nurse regarding a 77 year old female who on 15Oct04 at 9:50AM was vaccinated IM in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P). Concomitant therapy included a fourth dose of Fluzone (lot U1380AA) administered in the left deltoid. It was reported that the pt developed a red swollen arm at the injection site after receiving pneumococcal 23v. It was also reported that the pt was seen in the clinic and diagnosed with cellulitis. The pt was treated with an antibiotic. The reporter indicated that the cellulitis was considered to be an important medical event (OMIC). The nurse reported that two other female pt's had similar experiences with the pneumococcal 23v in the past two weeks. There was no product quality complaint involved. Follow up information from the nurse indicated that the pt developed pain, erythema and swelling in the right upper arm about two to three hours after the injection. The pt also had chills and nausea but no fever. The nurse suspected an infection or a possible allergic reaction; however, the pt has no history of drug allergies. It was reported that the pt recovered, date not specified.				Y					Y	10/15/2004	10/15/2004	0		UNK	UNK			The patient has no history of drug allergies.		200501305	1						1	Cellulitis; Chills; Hypersensitivity; Infection; Injection site erythema; Injection site oedema; Injection site pain; Injection site reaction; Nausea; Cellulitis; Chills; Injection site erythema; Injection site oedema; Injection site pain; Injection site reaction; Nausea	FLU3~SANOFI PASTEUR~U1380AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0490P~2~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~V1380AA~5~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0490P~2~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0241159	07/11/2005	OH	1.0	1	.0	F	06/30/2005	12/24/04, client had temp 102 or higher and had seizure. Brought to ER. Motrin given and observed and discharged. 12/25/04, 05:00 AM, another seizure. Called doctor and was instructed to give Motrin and Tylenol alternately. 01/19/05, seizure again. No temp, no illness. Started on Phenobarbital 1/20/05. EEG normal. Has an MRI scheduled, then Neurologist appt on 5/4/05. Has a family history of seizures (mom's nephew, mom's sister and mom's cousin. All grew out of them). Spoke with mom on 5/10/05 and pt had MRI on 4/25/05 and results were normal. Now weaning off Phenobarbital, last dose will be 5/29/05. So far, no seizure activity. Stated that pt didn't get fever with last set of immunizations but did get light rash which lasted x 3 days.				Y					N	12/17/2004	12/24/2004	7	MRI brain without contrast 4/25/05-normal. Note is made of moderate mucosal thickening in the maxillary and ethmoid sinuses bilaterally. Normal study.	PUB	PUB	Amoxil	NONE	Colds and fevers			1						1	Convulsion; Mucous membrane disorder; Pyrexia	FLU3~SANOFI PASTEUR~U1466AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0954N~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0241315	07/13/2005	UT	56.0	56		M	07/13/2005	ER visit 01/23/05; 9 days @ hospital.  No coordination of limbs, dble vision, nausea, weakness-overall lt. side leg and arm and rt. side of face.  Inability to swallow, walk or sit up w/o help.   Treatment-none.  Rehab, PT, OT, f/u PT after hopitalization. Per follow up report-Right side of face numb.  Weakness in extremities.				Y	Y	11			N	11/08/2004	01/23/2005	76	2 CT-brain, 3 MRI-brain and spine, carotid sonagram, renal sonagram, tested for MS, blood diease, spinal tap, multiple blood draws. 12/31/2009 left side numbness waist down, right side of face and dizziness.	UNK	UNK		none	abd. plasty, URI-fever with productive cough, GI problems-diarhea, vomiting and fever	Miller Fisher~Influenza (Seasonal) (Fluzone)~1~0.00~Patient		1						1	Asthenia; Coordination abnormal; Difficulty in walking; Diplopia; Dizziness; Dysphagia; Hypoaesthesia; Hypoaesthesia; Lumbar puncture; Nausea; Nuclear magnetic resonance imaging brain; Scan brain; Ultrasound Doppler; Ultrasound kidney	FLU3~SANOFI PASTEUR~U1379AA/U1456AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0241339	07/15/2005	MD	35.0	34		M	07/07/2005	Subject noted forehead swelling on 06/29/2005, the day following vaccination.  On 07/01/2005 he noted painful hives on both legs and on 07/02/2005, he developed bilateral ankle swelling.  On 07/06/2005, he sought medical attention at the local hospital where he received intramuscularly and by mouth Benadryl.  Information recieved from discharge summary states dyspnea.				Y						06/28/2005	06/29/2005	1	Medical record states elevated WBC's. msv	OTH	PUB	NONE	NONE	Inguinal hernia 09/02 Information received from Discharge summary states asthma, drug abuse, pneumonia. msv			1						1	Asthma; Leukocytosis; Pain; Swelling; Urticaria	FLU3~SANOFI PASTEUR~U1579AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0241430	07/18/2005	AZ	44.0	43		F	07/07/2005	right deltoid 6cm x 6cm erythemous warm and tender.  pain level at 5, on a scale of 10, afebrile, onset evening of 11/18/2004, and pain through the night.				Y					Y	11/18/2004	11/19/2004	1	NONE	PUB	OTH						1						1	Erythema; Feeling hot; Pain; Tenderness	FLU3~SANOFI PASTEUR~U1453DA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0287P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0241458	07/18/2005	VA	42.0	42		M	07/18/2005	First, my sincere apologies for the delay in reporting as I have only just learned of the VAERS program.  This is to report a series of two ANTHRAX innoculations received in 1999 (reported on separate forms), that may be a factor in prolonged and chronic health changes I have experienced since approx May 2001.  Of note, I was also exposed to Tuberculosis in that time frame and exhibited a positive PPD (20mm induration), and subsequently underwent TB preventative treatment with Isoniazid (INH). I have a detailed medical history of monthly visits and lab tests following the INH program and can provide copies.     An immediate and pronounced effect was noticed in May 2001 after the INH program began, most notably exhibited as extreme fatigue, joint pain, arthralgia, loss of range-of-motion, lower back pain, lack of stamina, and loss of strength.  The addition of B-6 to the INH regimen was began in July 2001 and some relief was noted.  Continued problem with joint pain caused me to be seen by the Rheumatology Clinic in Aug 01...no previous history of arthralgia.  After transfer in 2002, began experiencing increased kidney pain (LRQ), fatigue, short-term memory loss, and irregular heartbeat/palpitations.  Echocardiogram performed (negative), thyroid levels checked.  During entire period, Physical Fitness Test (PFT) performance continued to decline and failures were noted.  Generalized chest pain continued into 2004, self-admitted to ER on 17SEP04.  Stress test negative.  Began Prevacid treatment.  Honorably discharged in May 2005 before retirement.     Although the significant decline in health seemed to begin in May 2001 following INH treatment, I have found no linkages between INH side-effects and my experiences.  My concern is that this long-term effect, which persists to this day, is potentially connected with the Anthrax vaccinations received in 1999, and/or interactions between INH and the Anthrax vaccine.				Y					N	11/01/1999	05/29/2001	575	Numerous HEP Panels and blood-work tests were conducted throughout 2001-2004, and these results are available for review,although too voluminous to include here.  In May 2001 it was noted that the ANA SCR was positive (ANA Titer 1:60, speckled) and was considered clinically significant.	MIL	OTH	NONE	NONE	NONE			1						1	Amnesia; Arrhythmia; Arthralgia; Asthenia; Back pain; Fatigue; Joint range of motion decreased; Palpitations	ANTH~EMERGENT BIOSOLUTIONS~FAV024~1~IM~LA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~NO168AA~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0241473	07/19/2005	WA	0.17	0	.2	M	07/18/2005	This subject is a two month old male, who developed a fever while enrolled. The subject received the study vaccine on 7/8/05. The subject developed a fever of 101 degrees F on the same date as the study vaccine was given. The parents took the infant to the emergency room. As per the subject's father, a septic work up was performed and the infant was admitted to the hospital overnight. The father stated that all labs were normal and the infant's temperature went down. Treatment provided was antibiotics for 48 hours. The subject recovered. The fever was reported by the investigator as related to the study vaccine.					Y	1			Y	07/08/2005	07/08/2005	0	Septic work up performed; results not provided.	UNK	UNK					200501332	1						1	Pyrexia	FLU3~SANOFI PASTEUR~U1535AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0241637	07/22/2005	GA	60.0	60		M	07/18/2005	Client called on 7/18/05 to report injection site pain since 11/22/05. Pain when raising R arm.									N	11/22/2004				PUB	PUB	Ativan 1mg 1-2 qd; Multivitamins + B12		Vertigo, nerves, panic attacks, severe depression			1						1	Injection site pain; Joint range of motion decreased	FLU3~SANOFI PASTEUR~U1555AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0241775	07/26/2005	OH	58.0	57		F	01/31/2005	Pt getting 1st pneumonia shot, right deltoid. Reported soreness at site but Sunday am (approx 30 hours later) noted larger amount of redness around injection site and raised bumps (hive-like down arm)  Contacted physician and was advised to take Benadryl and be seen if no improvement. Monday  Continues with milder symptoms today. 1/31/05 Wed follow up with doctor if worsens or no improvement.									N	01/28/2005	01/30/2005	2	N/A	UNK	UNK	Acromax, Lipitor	N/A	Denies allergies, had a mini stroke 1 year ago.			1						1	Injection site erythema; Injection site pain; Urticaria	FLU3~SANOFI PASTEUR~U1418AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0513P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0241786	07/27/2005	NY	55.0	54		F	12/27/2004	From initial information received on 11/5/04 from a physician regarding an adverse event, it was reported that a 54 year old female patient received a FLUZONE vaccination, lot U1478AA, administered in the right deltoid on 10/21/04. The route of administration was not reported. Approximately ten to fourteen days post vaccination (onset date reported as 10/31/04), the patient developed symptoms of diffuse myalgia of the neck and shoulders, which gradually progressed downward to the legs and feet. The patient was seen by a physician, who was to investigate for possible polymyositis. The patient's past medical history includes asthma. She also had an unspecified viral illness on 9/22/04. At the time of this report, the patient had not recovered from these events. From additional information received on 12/1/04 from the reporting physician, it was reported as of 11/23/04 the patient was improving but is still myalgic. Follow up information received on 7/20/05. Based upon additional medical information, this case is being upgraded to serious. It was reported that the patient still has bilateral lower extremity claudication symptoms of undetermined etiology. The events have been persistent since November 2004 and the patient has been seen by a neurologist. An EMG and non-invasive studies were negative. An MRI of the brain was completed on 2/7/05 and was negative. The results of an MRI of the spine are pending. The patient's past medical history is significant for mild spondylosis, which was diagnosed in October 1998. At the time of this report, the patient has not recovered from the events. (OMIC)				Y					N	10/21/2004	10/31/2004	10	From additional information received on 12/1/04: Normal TSH, CK, CMP, and Sed rate. Calcium 10.3, repeat 9.3. From additional information received on 7/20/05: EMG negative; Non-invasive studies negative; Brain MRI on 2/7/05 negative; MRI spine pending.	PVT	PVT	Pulmicort; Serevent		The patient has a past medical history of asthma. On 9/22/04she had an unspecified viral illness. From additional information received on 12/1/04, it was reported that the patient also had a rash with the viral illness in September 2004. From additional information received on 7/20/05, it was reported that the patient was diagnosed with mild spondylosis in October 1998.		200403621	1						1	Intermittent claudication; Myalgia; Polymyositis	FLU3~SANOFI PASTEUR~U1478AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0241787	07/27/2005	CA	0.61	0	.6	M	07/25/2005	From initial information received on 29Nov04 from a health care professional regarding an adverse event occurring, it was reported that a seven month old male pt received his second dose of Fluzone SV 2004-2005 vaccination at 1:15PM on 29Nov04. The pt had no illnesses at the time of vaccination, no known allergies and was not taking any concomitant medications. Approx 2:30PM that same day, the pt developed intermittent body twitching. He was seen in the doctor's office and now has twitching of both arms. The pt's recovery status is reported as unk. Follow up information received on 18Jul05. Based upon new medical information, this case is being upgraded to serious. The pt was seen at a physician's office on 29Nov04. The parents reported that the pt had short jerking episodes. The episodes would occur every 45 seconds to one minute.  The pt was awake during the episodes and would otherwise appear normal. The pt was admitted to the hospital that same day, where it was noted that he had myoclonic jerks that looked a lot like startle reflex. The occurrence of the episodes gradually wore off until they were intermittent and then once every six to eight hours. An electroencephalogram was normal for age and there were no focal spikes. An MRI of the brain showed an incidental finding of Arnold Chiari type 1 malformation with a downward displacement of the cerebral tonsil into the upper cervical canal. The physician reported that this was an incidental finding and was unrelated to the current problem. It was felt that there was no need for any anti seizure medications, just clinical observation. The pt was to be seen for follow up in a neurology clinic in one month. The subject was discharged from the hospital on 30Nov04 and has recovered from these events.				Y	Y	2			Y	11/29/2004	11/29/2004	0	An electroencephalogram was normal for the pt's age and showed no focal spikes. An MRI of the brain showed an incidental finding of Arnold Chiari type 1 malformation with a downward displacement of the cerebral tonsil into the upper cervical canal. Relevant lab tests included a urine drug screen, which was negative. Urinalysis showed a specific gravity of 10.20, pH 6, otherwise negative. The pt's initial white count was 18,700, hemoglobin 13, hematocrit 39, platelets 494,000 with a differential of 22 polys, 6 lymphocytes, 9 monos, 2 eosinophils. A comprehensive metabolic panel showed a sodium of 140, potassium 5, chloride 107, carbon dioxide 24, glucose 118, blood urea nitrogen 8, creatinine 0.4, total calcium 10.5, magnesium 2.5, serum glutamic-oxaloacetic transaminase 52, serum glutamic-pyruvic transaminase 25, alkaline phosphatase 341, total protein 6, albumin 4.7, globulin 1.3. He had a pm cortisol which was normal, a c-reactive protein of 1 and creatinine phosphokinase of 219. Stool samples were negative for Roto virus and Clostridium difficile.	UNK	UNK			The pt had no illnesses at the time of vaccination. He has no known allergies.		200403838	1						1	Convulsion; Dyskinesia; Laboratory test abnormal; Muscle twitching; Myoclonus; Nervous system disorder	FLU3~SANOFI PASTEUR~U1381AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0241842	07/27/2005	FL	0.15	0	.1	F	07/26/2005	This case was reported by a consumer and described the occurrence of mental fogginess in a 2 month old female subject who was vaccinated with combined diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined for prophylaxis. The reporter is the subject's father. A physician or other health care professional has not verified this report. Previous and/or concurrent vaccinations included combined diphtheria, tetanus, acellular pertussis, hepatitis B and inactivated poliomyelitis vaccine given on 5/05 and 7/05. Medical history noted the subject has a male twin who also received Pediarix at 2-4-6 months; however, no personality change was noted with any Pediarix vaccinations. On an unspecified date in March 2005, the subject received first dose of Pediarix (lot number not specified). Concurrently, the subject also received injections of influenza virus vaccine and 7-valent pneumococcal conjugate vaccine. On an unspecified date in March 2005, at an unspecified time after vaccination with Pediarix, the subject experienced mental fogginess. The father stated his daughter was in a fog after vaccination with Pediarix. The father reported that his daughter continued to receive Pediarix at both the 4 (May 2005) and 6 (July 2005 month intervals. This case was assessed as medically serious (OMIC). At the time of reporting, on 7/25/05, the event was resolved.									Y	03/01/2005			UNK	PVT	PVT		UNK			A0567605A	1						1	Mental impairment	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~~1~~~DTAP + HEPB + IPV (PEDIARIX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PNC~PFIZER\WYETH~~UNK~~~PNEUMO (PREVNAR)~1	USA		Influenza
0241957	08/01/2005	WA	3.0	3		M	03/14/2005	Father presents child with swollen, erythema rt arm at inj site. No fever. Child playing and using arm. No blistering/streaking. Home care: cold pack, ibuprofen, at father choice. See if change or increase sx Dr call, no given. f/u phone call 3/14, sx resolving.									Y	03/09/2005	03/11/2005	2		PUB	PUB	NONE	NONE	NONE		WA052112	1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1530AB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0242028	08/03/2005	WI	54.0	54		M	07/12/2005	Pt reports awakening on the AM of 01/08/05 with paresthesia at right arm and right leg. Noticed right foot flopping during his exercise walk that AM. Continues to have intermittent right UE and LE paresthesia until present time. Approx 04/01/2005 developed generalized twitching of muscle in all 4 extremities.									U	01/05/2005	01/08/2005	3	3 MRI's to r/o m.s or spinal cord impingement EMG right leg. Extensive blood testing. Neuro work up still underway.	PUB	PVT	NONE	NONE	Allergic to cat dander, seasonal allergies r/t pollen			1						1	Muscle twitching; Paraesthesia	FLU3~SANOFI PASTEUR~U1557A~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0229490	08/04/2005	KS	79.0	79		F	07/29/2005	Information has been received from a licensed practical nurse concerning a 79 year old female with no known drug allergies who at 2:45 on Nov 4 2004 was vaccinated in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). On Nov 04 2004, the patient was concomitantly vaccinated in the right deltoid with a dose of influenza virus split virion 3v vaccine inactivated (Fluvax) (lot U1462AA). On Nov 05 2004, the patient developed a red, sore arm at injection site (site not specified). Her arm was painful to use. No treatment was administered. Subsequently, the patient recovered. No further information is available.									Y	11/04/2004	11/05/2004	1	UNK	PVT	PVT			UNK		WAES0505USA00205	1						2	Hypokinesia; Injection site hypersensitivity; Injection site pain; Pain	FLU3~SANOFI PASTEUR~U1462AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0529P~UNK~~UN~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0229491	08/04/2005	KS	85.0	85		M	07/29/2005	Information has been received from a licensed practical nurse concerning an 85 year old male with a penicillin allergy who on Oct 26 2004, was vaccinated subcutaneously into the left deltoid, with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). Concomitant therapy included an intramuscular second dose into the right deltoid of influenza virus split virion 3v vaccine inactivated (Fluzone) influenza virus split virion 3v vaccine inactivated (batch U1462AA). Subsequently, the patients left arm was very sore. It was noted that there was no treatment given. Three or four days later, the patient recovered. No further information is expected.									Y	10/26/2004			UNK	PVT	PUB			Penicillin Allergy		WAES0505USA00203	1						2	Pain	FLU3~SANOFI PASTEUR~U1462AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0513P~2~SC~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0232189	08/04/2005	TX	61.0	61		F	07/29/2005	Information has been received from a registered pharmacist concerning a 61 year old white female with no allergies or past medical history who on Jan 11 2005 at 4:00 pm was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649978/0709P), in the left deltoid. Concomitant therapy that day and time included influenza virus split virion 3v vaccine inactivated (Fluzone) (influenza virus split virion 3v vaccine inactivated) (lot 41559BA), in the left deltoid. Other therapy included alendronate sodium and atorvastatin calcium (Lipitor). The patient experienced red radial streaks from the injection site to her hand. The streaks seemed to follow her lymph ducts. There was also erythema and redness. It was reported that she was given something for the allergic response and an antibiotic. Follow up from a nurse in the patients doctors office reported that the patient also had swelling. It was also reported that on Jan 12 2005 the patient had left arm pain, red and swelling which started over night from deltoid down to antecubital fossa. The patient was treated with cephalexin (Keflex) 500 mg (QID x 7 days), diphenhydramine HCL (Benadryl) every 4-6 hours, and otc pain reliever. On Jan 13 2005 the patient took acetaminophen (Tylenol) (one to two tablet every 4 hours) for pain. The patient recovered. It was noted that the patient did not experience an adverse event following prior vaccination. No product quality complaint involved. No further information is expected.				Y						01/11/2005	01/12/2005	1	UNK	OTH	OTH	Fosamax, Lipitor		NONE		WAES0501USA01361	1						2	Erythema; Hypersensitivity; Cellulitis; Erythema; Hypersensitivity; Injection site reaction; Oedema; Pain	FLU3~SANOFI PASTEUR~U15598A~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0709P~UNK~~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~41559BA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0709P~1~~UN~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0235150	08/04/2005	IL	31.0	30		M	07/29/2005	Information has been received from a licensed practical nurse concerning a 30 year old male with asthma and no known allergies who on Jan 07 2005, at approximately 10:00am, was vaccinated IM in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N). Concomitant vaccination that day at the same time included a first dose in the left deltoid of influenza virus whole virion 3v vaccine inactivated (Fluzone) (Lot U1531AA). Other concomitant medication included fluticasone propionate (+) salmeterol xinafoate (Advair). zafirlukas (Accolate), ibuprofen, acetaminophen (Tylenol) and azithromycin (Zithromax. Illness at the time of vaccination included a URI and sinusitis, On Jan 09 2005, the patient developed redness, tenderness, swelling and pain in the vaccinated arm, with decreased range of motion, nausea and vomiting. On Jan 10 2004, the patient went to the emergency room, and subsequently, was hospitalized for cellulitis. The patient was treated with ampicillin sodium (+) sulbactam sodium (Unasyn), IV, methylprednisolone sodium succinate (Solu-medrol), IV, and acetaminophen (+) propoxyphene napsylate (Darvocet-N 100) while in the hospital. It was reported that the patient was discharged from the hospital. and subsequently, recovered. Follow up information has been received from a LPN and medical records. The nurse reported redness, swelling and pain at the site of injection along with a severe headache,. the patient went to the ER on Jan 09 2005 and got scripts for po amoxicillin (+) clavulanate potassium (Augmentin) and IM ceftriaxone sodium (Rocephin). Diagnosis was left arm cellulitis, The medical records indicated that on exam, the arm was very red (erythema) and hot (warmth) with swelling and fever. At the visit the patient reported that it hurt to raise or move the arm . Laboratory results from Jan 09 2005 included a WBC of 12.8 with segs of 88% and a sed rate of 35mm/hr. The nurse reported that the redness, pain, swelling and warmth at the site increased. The patient also had decreased ROM and nausea and vomiting developed. The patient was admitted to the hospital on Jan 10 2005 with diagnosis of cellulitis and sinusitis. medical records indicated that the chief complaint at admission included weakness, nausea, vomiting, headache and pain and redness in the left arm. Treatment included IV fluids, IV methylprednisolone sodium succinate (SOLU-MEDROL), IV ampicillin sodium  (+) sulbactam sodium (Unasyn), Iv metoclopramide hydrochloride (Reglan), guaifenesin (+) phenylephrine hydrochloride (+) phenypropanolamine hydrochloride (Entex PSE), acetaminophen (+) propoxyphene napsylate (Darvocet-N), saline spray and amantadine hydrochloride. Influenza AB screen neutrophil count and sed rate were all increased. See laboratory section for all relevant results. It was reported that the patient recovered on Jan 24 2005. Additional information is not expected.				Y	Y				Y	01/07/2005	01/09/2005	2	01/09/2005 83.2% 30-70 neg ; 10.6 10^3/  1.3-7.4 neg; 88% 30-70 neg. 01/11/2005 Influenza AB screen-presumptive negative.   Absolute Neutrophil 01/10/2005 8.76 k/cm 1.6 - 8.3 Hemoglobin 01/09/2005 14 g/dl 14-18 Erythrocyte 01/09/2005 35 mm/hr 0-15 Erythrocyte 01/10/2005 43 mm/hr 0-15 Erythrocyte 01/12/2005 36 mm/hr 0-15 Glomerular filtration 01/07/2005 105 ml/mi 0-60 Glomerular filtration 01/10/2005 105 ml/mi 0-60 Plasma LDL-C 01/07/2005 166 mg/dl 0-130 Red blood cell count 01/09/2005 4.84 10^6/ 4-6 Serum alanine 01/07/2005 72 u/l 0-35 Serum alanine 01/10/2005 46 u/l 0-35 serum aspartate 01/07/2005 42 u/l 0-35 serum cholesterol 01/07/2005 216 mg/dl 0-200 serum HDL-C 01/07/2005 45mg/dl 0-45 urine specific gravity 01/07/2005 1.036 high urine squamous 01/07/2005 rare WBC count 01/09/2005 12.8 10^3 4.5 - 10.5 WBC count 01/10/2005 10.95 k/cum 4.5 - 10.8 hematocrit 01/09/2005 42.5% 42-52	PVT	PVT	Tylenol, Zithromax, Advair, ibuprofen, Accolate	Sinusitis, Upper respiratory tract infection	Asthma		WAES0501USA04558	1						2	Cellulitis; Headache; Hypokinesia; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Laboratory test abnormal; Medication error; Nausea; Pain; Pyrexia; Vomiting; Alanine aminotransferase increased; Aspartate aminotransferase increased; Asthenia; Blood cholesterol increased; Cellulitis; Erythema; Feeling hot; Headache; Hypokinesia; Injection site oedema; Injection site pain; Injection site reaction; Laboratory test abnormal; Nausea; Pyrexia; Red blood cell abnormality; Tenderness; Urine analysis abnormal; Vomiting; White blood cell count increased; White blood cell disorder	FLU3~SANOFI PASTEUR~U1531AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0946N~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U15311AA~1~~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0946N~1~IM~~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0241149	08/04/2005	WI	78.0	77		F	07/29/2005	Initial and follow up information has been received from a licensed practical nurse concerning a 77 yr old retired female who on 15Oct04 at 9:50AM was vaccinated IM in the right deltoid, with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P). Concomitant therapy included a fourth dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (lot V1380AA) administered IM in the left deltoid. It was reported that the pt developed red, swollen arm at the injection site after receiving pneumococcal 23v polysaccharide vaccine. It was also reported that the pt was seen in clinic and diagnosed with cellulitis. The pt was treated with antibiotic as an intervention. The reporter indicated that cellulitis was considered to be an other important medical event (OMIC). The nurse reported that 2 other female pt's had similar experiences with pneumococcal 23v polysaccharide vaccine (WAES0410USA02650 and 0410USA03090) in the past two weeks. There was no product quality complaint involved. Follow up information from the nurse indicated that the pt developed pain, erythema and swelling in right upper arm about 2-3 hours after injection. The pt also had chills and nausea but no fever. The nurse suspected an infection or possible allergic reaction however the pt has no  history of drug allergies. It was also reported that the pt recovered (date unspecified).				Y					Y	10/15/2004	10/15/2004	0	UNK	OTH	OTH			NONE		WAES0410USA03089	1						2	Cellulitis; Chills; Hypersensitivity; Infection; Injection site erythema; Injection site oedema; Injection site pain; Injection site reaction; Nausea; Cellulitis; Chills; Injection site erythema; Injection site oedema; Injection site pain; Injection site reaction; Nausea	FLU3~SANOFI PASTEUR~U1380AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0490P~2~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~V1380AA~5~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0490P~2~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0242122	08/04/2005	IL	39.0	38		F	07/29/2005	Information has been received from a registered nurse concerning a 38 year old female patient who on Nov 14 2003 at 10:00am was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 643249/0358M), in the right arm intramuscularly. Concomitant therapy that day included an influenza virus vaccine (unspecified) (lot 765876), in the left arm intramuscularly. There was no illness at the time of vaccination. It was reported that several hours post vaccination, the patient developed an injection site reaction of redness and swelling. This initial reaction resolved within days. Once a month since the vaccination, the patient develops an itchy papule at the same site that lasts for a day or so and then resolves. It was also reported that day after shot patient had redness, swelling and itching at injection site. This reportedly subsided after approximately one week. it was also reported that since then monthly same injection site area becomes raised, red and itchy. Unspecified medical attention was sought, but treatment was not required. A product quality complaint was not involved. Additional information has been requested.				Y					U	11/14/2003	11/14/2003	0	UNK	OTH	PUB			UNK		WAES0406USA02041	1						1	Injection site hypersensitivity; Injection site oedema; Injection site reaction; Injection site swelling; Pruritus; Rash papular	FLU3~EVANS VACCINES~765876~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0358M~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0242221	08/04/2005	IL	42.0	41		F	07/29/2005	Initial and follow up information has been received from a registered nurse concerning a 41 year old female who on 09/28/2004 was vaccinated intramuscularly in the right deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P).  On 09/28/2004, the patient was also vaccinated intramuscularly in the left deltoid with a dose of concomitant therapy influenza virus split virion 3v vaccine inactivated (Fluzone).  Other concomitant therapy included Necon, MSD, Biaxin, and Avelox.  Subsequently, 09/28/2004, she experienced tender redness and warmth from her shoulder down to her elbow with pain.  Unspecified medical attention was sought and it was reported that the adverse experience improved on therapy.  In follow up, the nurse reported that on the morning of 09/29/2004, the patient developed a large area of redness, warmth and tenderness at the site of vaccine given in the right arm/deltoid area.  The patient was seen in the physician's office.  On 10/18/2004, the patient recovered.  There was no product quality complaint involved.  No additional information is expected.				Y					Y	09/28/2004	09/28/2004	0	NONE	PVT	PVT	Fosamax, Biaxin, Necon, Avelox		NONE		WAES0409USA02733	1						1	Erythema; Feeling hot; Injection site pain	FLU3~SANOFI PASTEUR~U1446AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~649696/0490P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0242255	08/04/2005	MO	52.0	52		F	07/29/2005	Information has been received from a nurse practitioner concerning a 52 year old female with COPD, HTN and GERD who on Oct 14 2004 was vaccinated intramuscularly in the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 647657/0947N). Concomitant vaccine therapy given intramuscularly in the left deltoid included a dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (lot U1410BA). There was no illness at the time of vaccination. That same day the patient developed shortness of breath, and erythema, induration and diffuse edema in the right upper arm. That night the patient visited the ER after developing a fever. After several days, the patient recovered. the patient did not have any adverse events following prior vaccinations. No product quality complaint was involved. No further information is expected.				Y					Y	10/14/2004	10/14/2004	0	Body temp 10/14/2004 fever	PUB	PUB			Chronic obstructive pulmonary disease, hypertension, Gastroesophageal reflux disease.		WAES0410USA02397	1						1	Dyspnoea; Erythema; Injection site induration; Oedema; Pyrexia	FLU3~SANOFI PASTEUR~U1410BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0947N~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0242258	08/04/2005	WI	78.0	78		F	07/29/2005	Information has been received from a licensed practical nurse concerning a 78 year old retired white female with no known drug allergies who on Oct 13 2004 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P), intramuscularly in the right deltoid. Concomitant therapy that day included a sixth dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (lot U1411AA), intramuscularly in the left deltoid. The patient was seen on Oct 15 2004 with redness and pain in the right upper arm. The arm was swollen and warm to touch. Cellulitis was reported. The patient was treated with ciprofloxacin hydrochloride (Cipro) (500) (x 4 days). The reporter indicated that cellulitis was considered to be an other important medical event. There was no product quality complaint involved. The patient recovered. Follow up indicated that the cellulitis was not an was not an other important medical event. The nurse reported that 2 other female patients had similar experiences with pneumococcal 23v polysaccharide vaccine (WAES0410USA03089, WAES0410USA03090) in the past two weeks. No further information is available.				Y					Y	10/13/2004	10/15/2004	2	UNK	PVT	PVT			UNK		WAES0410USA02650	1						1	Cellulitis; Feeling hot; Hypersensitivity; Oedema; Pain	FLU3~SANOFI PASTEUR~U1411AA~6~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0513P~2~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0242260	08/04/2005	TX	17.0	16		F	07/29/2005	Initial and follow up information has been received from a registered nurse and a physician concerning a 16 year old white female student with a cefaclor (Ceclor) allergy, asthma and allergic rhinitis who on Oct 15 2004, at 1:15pm, was vaccinated IM in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P). Concomitant vaccination, at the same time, on Oct 15 2004 included a dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (lot U1496AA), also administered IM in the left deltoid. Additional concomitant therapies include desloratadine (Clarinex), drospirenone (+) ethinyl estradiol (Yasmin), escitalopram oxalate (Lexa pro), trazodone hydrochloride, fluticasone propionate (Flonase), and fluticasone propionate (+) salmeterol xinafoate (Advair)(250/50 mcg). On Oct 17 2004 the patient called the office to report a red and tender reaction at the injection site with was 3 x 6 inches. The patient was treated with ice packs and ibuprofen (Motrin) for the pain, The patient called again on Oct 18 2004 and reported a 104 degree fever and swelling and redness at the injection site of 7 x 4 inches (also reported as 10x20 centimeters). It was also reported that it was very painful and she was unable to move her arm, symptoms were not relieved by ibuprofen and ice. The patient came to the office ans was given acetaminophen (+) hydrocodone bitartrate (Vicodin) and ice packs for the pain. As of Oct 19 2004 the inject site was still painful and red, but it was reported that she was recovering. She was given naproxen (Naprosyn) for the pain, It was also reported that th patient was prescribed cephalexin (Keflex) for suspected cellulitis and referred to the emergency room for evaluation of suspected myoglobinuria, which was ruled out. The patient was seen in the hospital emergency room on Oct 22 2004 and had a left upper extremity ultrasound, which indicated subcutaneous edema and no abscess. The following diagnostic laboratory tests were performed on Oct 22 2004 and reported below normal: blood hemoglobin test 11.7 g/dl, blood lymphocyte count 24.6%, serum creatin Kinase test 27 u/l, whole blood hematocrit 34.1%, urin specific gravity measurement 1.000, serum sodium test 135 mEg/L, and red blood cell count 3.88m/mm3. Both white blood cell count and blood platelet count were reported above normal at 12.9 K/mm3 and 463 T/mm3, respectively. The physician reported that the patient had one previous dose of pneumococcal 23v polysaccharide vaccine (date not reported) and more than 10 previous vaccinations with influenza virus split virion 3v vaccine inactivated. It was also reported that at the time of vaccination, the patient has generalized aches and pains with subjective fevers and sore throat, no corroborative physical findings or specific etiology. the patient recovered on Oct 31 2004. There was no product quality complaint involved. Additional information is not expected.				Y					Y	10/15/2004	10/17/2004	2	ultrasound 10/22/2004 subcutaneous edema, no abscess, LAB TESTS: hemoglobin 11.7 g/dl low, lymphocyte count 24.6% low, platelet count 463T/mm3 high, body temp 104, WBC count 12.9 K/mm3 high, hematocrit 34.1% low, urine specific gravity 1.000 low, red blood cell count 3.88M/mm3 low, serum creatine kinase 27U/L low, serum sodium 135 mEg/L low.	PVT	PVT	Clarinex, Yasmin, Lexa pro, Flonase, Advair, trazodone hydrochloride	Fever, General body pain, sore throat	Drug hypersensitivity, Asthma, Rhinitis allergic		WAES0410USA03048	1						1	Blood sodium decreased; Cellulitis; Haematocrit decreased; Haemoglobin decreased; Hypokinesia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Laboratory test abnormal; Lymphocyte morphology abnormal; Platelet count increased; Pyrexia; Red blood cell count decreased; Scrotal oedema; Tenderness; Urine abnormality; White blood cell count increased	FLU3~SANOFI PASTEUR~U1496AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0490P~2~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0242263	08/04/2005		45.0	45		F	07/29/2005	Information has been received from a Doctor of Pharmacy concerning a 45 year old female with no known allergies who on Oct 10 2004 was vaccinated in the right arm with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649693/0486P). On Oct 10 2004, the patient was concomitantly vaccinated in the right arm with a dose of influenza virus vaccine. Subsequently, in October 2004, the patient developed a fever, hives and severe muscle pain. The patient sought unspecified medical attention. At the time of this report, the patients hives had decreased. The Doctor of Pharmacy also reported another patient who had similar reaction post vaccination with pneumococcal 23v polysaccharide vaccine  (lot # 649693/0486P) (WAES0411USA01558). Additional information has been requeste.				Y					N	10/10/2004			UNK	OTH	OTH			UNK		WAES0410usa03303	1						1	Myalgia; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0486P~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0242264	08/04/2005	PA	80.0	80		F	07/29/2005	Information has been received from a licensed practical nurse concerning an 80 year old retired white female with an allergy to indomethacin (Indocin) who on Oct 19 2004 was vaccinated intramuscularly with a dose of pneumococcal 23v polysaccharide vaccine (lot 649695/0512P). Concomitant vaccine therapy given intramuscularly included a dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (batch R1410BA). there was no illness at the time of vaccination . On oct 06 2004 the patients arm hurt and had developed diffuse erythema, tenderness, and swelling of the right arm. The area was about 5 inches long by 3 inches wide from the top of her arm to the elbow. On Oct 20 2004 the patient was seen in the physicians office. The patient was treated with cetirizine hydrochloride (Zyrtec), celecoxib (celebrex) and warm compresses. On Oct 27 2004 the patient recovered. No product quality complaint was involved. No further information is expected. This is a consolidation of two reports concerning the same patient.				Y					Y	10/19/2004	10/19/2004	0	UNK	PVT	OTH	UNK		Drug Hypersensitivity		WAES0410USA03308	1						1	Erythema; Oedema; Pain; Tenderness	FLU3~SANOFI PASTEUR~U1410BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0512P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0242347	08/04/2005	IA	47.0	47		F	07/29/2005	Information has been received from a licensed practical nurse concerning a 48 year old female with an allergy to Biaxin who on 10/28/2004 at 1548 was vaccinated in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N).  Concomitant vaccine therapy given in the left deltoid included a first dose of influenza virus vaccine (unspecified) (lot u1449AA).  There was no illness at the time of vaccination.  At 1730 the patient developed pain, redness, warmth and swelling at the injection site.  The arm was very sore and it hurt to use it.  The patient was afebrile.  Unspecified medical attention was sought.  No diagnostic lab tests were performed.  The symptoms lasted one day and the patient recovered.  It was also noted that the patient had no AE's following prior vaccinations.  No product quality complaint was involved.  No further information is expected.  It was also reported that another patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N) and developed an AE (WAES0411USA01318).				Y					Y	10/28/2004	10/28/2004	0	NONE	PVT	OTH			Drug hypersensitivity		WAES0411USA00295	1						1	Erythema; Feeling hot; Injection site swelling; Pain	FLUX~UNKNOWN MANUFACTURER~U1449AA~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~647724/0946N~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0242360	08/04/2005	OH	72.0	71		F	07/29/2005	Information has been received from a 71 yr old Caucasian female RN with no allergies and no medical history who on 03Nov04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 6499130577P), high on her right arm. Concomitant therapy the same visit included influenza virus vaccine (unspecified), in the left arm. There was no illness at the time of vaccination. Subsequently, about 3-4 hrs after vaccinations, she developed pain and is now unable to use her right arm. She was treated with ice, ibuprofen and heat. Follow up reported that the pt developed swelling, redness, pain, flu-like symptoms lasting 36 hrs from onset. There were no relevant diagnostic tests or lab data. The pt took naproxen sodium (Aleve). No further information is expected.									Y	11/03/2004	11/03/2004	0	NONE	OTH	PVT			NONE		WAES0411USA00828	1						1	Hypokinesia; Influenza like illness; Injection site erythema; Injection site oedema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0577P~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0242361	08/04/2005	OH	83.0			F	07/29/2005	Information has been received from an 83 yr old female with no past medical history and no allergies who on 03Nov04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy that day included influenzae virus vaccine (unspecified). On 03Nov04, about three hours after getting injection the pt experienced swollen and red injection site. No medical attention was sought. The pt was considered to be recovering. There were no lab or diagnostic tests performed. No product quality complaint involved. Additional information has been requested.				Y					N	11/03/2004	11/03/2004	0	NONE	OTH	OTH			NONE		WAES0411USA00831	1						1	Injection site erythema; Injection site oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0242372	08/04/2005	IA	40.0	40		M	07/29/2005	Information has been received from a licensed practical nurse concerning a 40 year old male with an allergy to penicillin who on Oct 29 2004 at 2:20 was vaccinated in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N). Concomitant vaccine therapy given in the left deltoid included a first dose of influenza virus vaccine (unspecified0 (lot U1449AA). There was no illness at the time of vaccination. On Oct 30 2004 at 2:30 the patient woke up with nausea and vomiting. He had a red, swollen, painful area where the injection was given. His had a temperature of 100.1 and he had pain in his neck that radiated across to his right shoulder. Unspecified medical attention was sought. No treatment or diagnostic lab tests were performed. On Nov 01 2004 the patients aches and temperature decreased and the redness and swelling went down. Subsequently, the patient recovered. No product quality complaint was involved. No further information expected. No further information is expected. It was also reported that another patient was vaccinated with dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N) and developed an AE (WAES0411USA00295).				Y					Y	10/29/2004	10/30/2004	1	body temp 10/30/2004 100.1	PVT	PVT			Penicillin Allergy		WAES0411USA01318	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Nausea; Pain; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~U1449AA~1~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0946N~1~~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0242397	08/04/2005	WI	76.0	75		F	07/29/2005	Information has been received from a licensed practical nurse concerning a 75 year old white female with no known drug allergies who in 1998 and on 10/12/2004 at 12:10 was vaccinated with a first and second dose of pneumococcal 23v polysaccharide vaccine (lot # 649029/0514P).  Concomitant therapy that day at 12:12 included an eleventh dose of influenza virus vaccine (Fluzone) (lot # U1380AA).  There was no illness at the time of vaccination.  On 10/12/2004 approximately 4 hours later, the patient experienced spreading redness at site and cellulitis at injection site.  The report indicates that the doctor prescribed amoxicillin clavulanate potassium (Augmentin).  Subsequently, the patient recovered from spreading redness at site and cellulitis at injection site.  The report indicates that the patient required medical attention.  No additional information is expected.				Y					Y	10/12/2004	10/12/2004	0	Unknown	PVT	PVT			Unknown		WAES0411USA02724	1						1	Cellulitis; Injection site erythema; Injection site reaction	FLU3~SANOFI PASTEUR~U1380AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~647029/0514P~2~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0242537	08/04/2005	ID	50.0	50		F	07/29/2005	Information has been received from licensed practical nurse concerning a 50 year old female who on Nov 17 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 649692/0371P). Concomitant therapy that day and in the same arm included influenza virus vaccine (unspecified, manufacture unknown). On Nov 17 2004 the patient experienced soreness, redness in injection are, flu like symptoms and fatigue, Over the counter anti inflammatory medication and ice were prescribed, The patient called the office on Nov 18 2004 with no improvement. It was reported that another patient had a similar reaction (WAES0412USA00149). Additional information has been requested.				Y					U	11/17/2004	11/17/2004	0	UNK	OTH	OTH			UNK		WAES0411USA03170	1						1	Fatigue; Influenza like illness; Injection site hypersensitivity; Injection site pain	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0371P~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0242561	08/04/2005	CO	54.0	54		F	07/29/2005	Information has been received from a woman from a physician's office concerning a 54 yr old white female with a history of cellulitis who on the afternoon of 29Sep04 was vaccinated IM in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647359/0740N). Concomitant vaccine therapy given IM in the left deltoid included a yearly dose of influenza virus vaccine (unspecified) (lot U1401BA). On the morning of 30Sep04 the pt developed a temp 101.5 and swelling and erythema over the shot site. Medical attention was sought and the pt's actual temp in the office was 99.9. It was reported that the pt received a 3 pak to prevent the reoccurrence of cellulitis. No diagnostic lab tests were performed. On 01Oct04 the pt recovered. No further information is expected.				Y					Y	09/29/2004	09/30/2004	1	Body temp 09/30/04 101.5; 99.5 temp in office.	PVT	PVT			Cellulitis		WAES0412USA01041	1						1	Injection site erythema; Injection site oedema; Pyrexia	FLUX~UNKNOWN MANUFACTURER~U1410BA~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0740N~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0242593	08/04/2005		0.42			F	07/29/2005	Information has been received from a physician regarding his 7 month old healthy daughter who on 26Dec04 he inadvertently vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot unk). Concomitant therapy on 26Dec04 included a dose of influenza virus vaccine (unspecified) and a dose of diphtheria toxoid (+) hep B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (Pediarix). The report indicated that medical attention was sought. On 26Dec04 the pt experienced a mild fever. It was reported that the physician transported the pneumococcal 23v polysaccharide vaccine overseas (country unk). At the time of the report the outcome is unk. Additional information has been requested.				Y					U	12/26/2004	12/26/2004	0	UNK	OTH	OTH			NONE		WAES0412USA02938	1						1	Medication error; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~DTAP + HEPB + IPV (PEDIARIX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0242597	08/04/2005	MO	58.0	58		M	07/29/2005	Information haws been received from a health professional concerning a 58 yr old white male with no known drug allergies and a history of cerebral vascular accident and coronary artery bypass graft with asthma, diabetes, bronchitis (chronic), gastroesophageal reflux disease, epilepsy, traumatic arthritis, depression and testosterone deficiency who on 08Dec04 at 2:00PM was vaccinated with an IM first dose in the right deltoid of pneumococcal 23v polysaccharide vaccine (lot 647797/0987N). Concomitant therapy that day included a first dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (IM) (Lot U1380AA). It was noted that there was no illness at the time of vaccination. It was reported that according to chart notes, the pt went to the ER on 08Dec04 in the evening with right deltoid redness and swelling, and was treated and released. On 09Dec04 the pt went to the ER. The pt c/o right arm warmth, tenderness, redness, swelling, pain and numbness. The pt also had shortness of breath. Current medications included clopidogrel bisulfate (Plavix), alprazolam, venlafaxine hydrochloride (Effexor), theophylline, ibuprofen, acetaminophen (+) hydrocodone bitartrate (Vicodin) and albuterol. The pt was treated with ceftriaxone sodium (Rocephin) (IM), methylprednisolone (Medrol), hydroxyzine pamoate (Vistaril), cephalexin (Keflex), acetaminophen (+) hydrocodone bitartrate (Vicodin) and warm compresses. He was instructed to return if worse. It was also reported that the pt went to urgent care on 10Dec04, per doctor, for the same symptoms and was treated and released. It was noted that the pt was given antibiotics and supported care was advised. Recovery status was unk. Follow up reported that no further contact with this pt. No further information is expected.				Y					U	12/08/2004	12/08/2004	0	UNK	PVT	PVT	Vicodin tablets, albuterol, alprazolam, Plavix, ibuprofen, theophylline; Effexor.		Cerebrovascular accident; coronary artery bypass, asthma, diabetes, bronchitis chronic, gastroesophageal reflux disease, epilepsy, traumatic arthritis, depression, testosterone decreased.		WAES0501USA00045	1						1	Dyspnoea; Feeling hot; Hypoaesthesia; Injection site erythema; Injection site oedema; Injection site pain; Tenderness	FLU3~SANOFI PASTEUR~U1380AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0987N~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0242620	08/04/2005	MI	44.0	44		M	07/29/2005	Information has been received from a certified medical assistant concerning a 44 year old disabled white male with chronic obstructive pulmonary disease and joint disease, who on Jan 12 2005 at 8:00, was vaccinated intramuscularly into the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647681/0986N). There was no illness at the time of vaccination. Concomitant therapy included an intramuscular dose of tetanus toxoid (batch U1341AA) into the right deltoid, a tuberculin purified protein derivative test (batch C1710AA) given into the left forearm and an intramuscular dose of influenza virus vaccine (unspecified) (U1499AA) into the left deltoid. That night, the patient awoke with a sore site, Unspecified medical attention was sought. An exam of the patient noted that he developed a 5x7 cm area of induration, warmth, and tenderness at the site. The patient was treated with prednisone 50 mg 40/30/20/10 one day each, diphenhydramine hydrochloride (Benadryl) 25mg four times daily, for 48 hours and cool packs for comfort, No diagnostic laboratory test were performed. On Feb 16 2005, the patient wsa seen for follow up an he had no complaints. the patient recovered at that time or sooner. It was also reported that there were no adverse events following prior vaccinations. No product quality complaint was involved. Additional information is not expected. It was also reported that another patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647681/0986N) and experienced adverse events (WAES0501USA04214).				Y					Y	01/12/2005	01/12/2005	0	NONE	PVT	OTH	Tuberculin purified protein derivative C1710AA		Chronic obstructive pulmonary disease, Joint dysfunction		WAES0501USA01706	1						1	Feeling hot; Injection site induration; Injection site pain; Tenderness	DTOX~UNKNOWN MANUFACTURER~U1341AA~UNK~IM~~DIPHTHERIA TOXOIDS (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~U1499AA~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0986N~1~IM~~PNEUMO (PNEUMOVAX)~1|TTOX~UNKNOWN MANUFACTURER~U1341AA~UNK~IM~~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0242636	08/04/2005	LA	58.0	57		M	07/29/2005	Information has been received from a pharmacist and a registered nurse concerning a retired 56 year old caucasian male with an allergy to codeine who on 01/21/2005 at 08:30AM was vaccinated intramuscularly in the right arm with the first dose of pneumococcal 23v polysaccharide vaccine.  Vaccination given on that same day included:  influenza virus split virion 3v vaccine inactivated given subcutaneously.  Concomitant medication included Celebrex 200mg daily.  There was no illness at the time of vaccination.  On 01/21/2005 at 16:30PM, the patient called the office to state that his arm was red, swollen and painful.  He was also short of breath and had a headache and fever.  As of 01/24/2005, his arm was still red, swollen and painful.  He was not short of breath, but was not feeling well.  It was reported that he recovered as of 01/26/2005.  Follow up information reported that the patient's left arm where injection was given was swollen, red, and very painful.  There was no diagnostic or laboratory tests performed.  No further information is available.									Y	01/21/2005	01/21/2005	0	NONE	PVT	PVT	Celecoxib		Drug hypersensitivity		WAES0501USA04551	1						1	Erythema; Headache; Pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U1561AA~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~650327/0792P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0242724	08/04/2005	IL	50.0	50		F	07/29/2005	Information has been received from a licensed practical nurse concerning a 50 year old white female with chronic obstructive pulmonary disease, obstructive sleep apnea, mitral valve disorder, cardiomegaly, depression, tobacco addiction, sulfa allergy, amoxicillin allergy, and cefazolin sodium allergy, who on 2/14/05 at 13:30 was vaccinated IM into the right deltoid with a 0.5ml first dose of pneumococcal 23v polysaccharide vaccine (lot # 649912/0529P). Illnesses at the time of vaccination were acute sinusitis, impacted cerumen, and pain in thoracic spine. Concomitant therapy included an IM dose into the left deltoid of influenza virus whole virion 3v vaccine inactivated (batch # U1500AA), azithromycin, pantoprazole sodium, sertraline HCl, estradiol, lisinopril, calcium, levofloxacin, acetaminophen/hydrocodone bitartrate, aspirin/butalbital/caffeine, and Sitrex. On 2/15/05, the patient was seen in the doctor's office with redness, swelling, and pain at the pneumococcal 23v polysaccharide vaccine injection site (right upper arm). She was treated with diphenhydramine hydrochloride, ice packs, and elevation of her arm. The patient's outcome was unknown. No product quality complaint was involved. The LPN considered the patient's adverse experiences to be other important medical events (OMIC). Additional information has been requested.				Y					U	02/14/2005	02/15/2005	1	UNK	PVT	PVT	Vicodin; Fiorinal; Z-Pak; Calcium; Estradiol; Levaquin; Lisinopril; Protonix; Zoloft	Acute sinusitis, Cerumen impaction, Pain in thoracic spine	COPD; Obstructive Sleep apnea syndrome; Mitral Valve disease; Depression; Nicotine addiction; Sulfonamide allergy; Penicillin allergy; Hypersensitivity; Cardiomegaly.		WAES0502USA02162	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1500AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0529P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0242304	08/05/2005	KY	50.0	50		F	07/28/2005	Diagnosis: G.B. Syndrome. 5/11/05 Sore throat, fatigue. 5/14/05 Numbness and tingling to hands and fingers. 5/15/05 Numbness/tingling to feet. 5/15/05 Deep throbbing, pain in arms up to elbows, pain in shoulders, increased NBC. 5/18/05 Difficulty with gait. 5/19/05 Hospitalized. 5/23/05 Transferred to another hospital and placed in ICU; Condition critical for 4 days. 5/24/05 Lumbar puncture. 5/25/05 LP findings, Guillain Barre. 5/30/05 Step down from ICU. 6/3/05 Admitted to physical therapy rehab facility. 7/28/05 As of this date, discharged planned for 8/2/05.   Received hospital medical records for 5/19-6/3/2005.  FINAL DX: acute inflammatory demyelinating polyneuropathy Records reveal patient experienced bilat ext numbness & tingling w/progressige arm/neck pain x 10 days prior to admit.  Had sore throat & fatigue approx 3 wks prior to onset of s/s.  Transferred from outlying hospital.  On admit to ICU, had weakness of all extremities, urinary retention, constipation, respiratory insufficiency. Neuro consult done.  Tx w/IVIG x 4.  Slow improvement & transferred to inpt rehab.  Per follow up report-Continued muscle weakness, numbness, tingling and pain to lower extremities.  Muscle instability.  Unsteady array gait. Per annual report-Continues to have numbness and tingling to lower extremities (feet & toes), balance is offset by this (numbness and tingling). Physical stamina has not returned to pre-illness level. Has decreased muscle strength in thighs and those muscles fatigue more easily.				Y	Y	15	Y	Y	N	10/12/2004	05/11/2005	211	Increased WBC; Physical therapy rehab; Diagnosis GBS; Lumbar puncture done approximately 5/24/05 - findings GBS. Medical records received 08/17/05 states CSF protein 66(H), hyponatremia, & EMG/NCS abnormal.	PUB	PUB	Fosamax 70mg q wk.	Health was good	NONE; Medical records received 08/17/05 states Pt Hx of allergy and depression.			1						1	Fatigue; Gait disturbance; Guillain-Barre syndrome; Hyponatraemia; Lumbar puncture abnormal; Muscular weakness; Muscular weakness; Pain; Pain in extremity; Paraesthesia; Pharyngolaryngeal pain; Shoulder pain; White blood cell count increased	FLU3~SANOFI PASTEUR~U1476AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0242335	08/05/2005	IA	0.33	0	.3	F	08/05/2005	On 7/27/05 my granddaughter was given all of her 4 month shots at the Dr. office.  On 8/5/05 we were called at home stating that they gave her the adult vaccine PPV instead of PCV.  She was then given the correct vaccine on 8/5/05.  After she was given the first shot on the 7/27/05 she was more cranky and sick.  For 2 days she did run a fever of 101.6 and did not eat all that much.  All she did was cry.  She was given tylenol and was given warm bathes.  Did contact a public health nurse that is assinged to pt and also contacted the CDC on getting the information to make sure she is going to be all right.									Y	07/27/2005	07/27/2005	0		UNK	UNK						1						1	Anorexia; Crying; Irritability; Malaise; Medication error; Pyrexia; Screaming	DTP~UNKNOWN MANUFACTURER~~2~~UN~DTP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~2~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~2~~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0242442	08/08/2005	IL	0.56	0	.6	M	08/08/2005	Mother reports that the day following the immunizations the child developed a runny nose, cough and fever that required a doctor visit. The child has subsequently been put on Pulmicort, Zyrtec, and Albuterol. He was hospitalized for 24 hours with a temp of 105 degrees in late May.  He has been seeing his primary physician almost weekly since April. Continues on medications and has coughing and wheezing symptoms. 11/07/05 Review of medical records indicates diagnosis of bronchiolitis. Additional symptoms include poor appetite and a candida diaper rash. 11/07/2005 hospital records reviewed. Added information that a blocked nasal lacrimal duct was noted on left.				Y	Y	1			N	02/03/2005	02/04/2005	1	Had blood work--unsure as to tests or results. Chest x-ray was normal.	UNK	UNK	none	none	none			1						1	Bronchiolitis; Cough; Decreased appetite; Eye disorder; Pyrexia; Rash; Rhinorrhoea; Wheezing	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A008AA~2~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1416A~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A74400A~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0230574	08/09/2005	OR	14.0			F	11/29/2004	This is a non serious case from a nurse in the USA of involving accidental exposure. The reported causality was not provided. This is a case of possible accidental exposure to FluMist. A parent called to report that she had developed sore throat, cough, weakness and fatigue with onset beginning the same day of administration (MEDI-0002477). While reporting her own adverse events she also stated that her 14 year old daughter also experienced sore throat, cough, weakness and fatigue beginning four days after the mother was vaccinated on Nov 10 2004. The child did not receive the vaccine and fully recovered on Nov 20 2004. Therefore, vaccine administration date, time and lot numbers are not applicable. Mar 04 2005 follow up information received from the reporter: confirmation that the patient never received FluMist.									Y		11/14/2004			OTH	OTH					MEDI0002481	1						2	Asthenia; Cough; Fatigue; Infection transmission via personal contact; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0232078	08/09/2005		21.0			F	05/04/2005	This is a non serious spontaneous case from a healthcare professional in the USA reporting that a medical support member had Accidental Exposure to FluMist while vaccinating military personnel. The reporter determined the events to be unrelated to FluMist administration. A 21 year old female medical support member developed headache and scratchy throat after accidental exposure during FluMist administration. Investigation into these events resulted in no definitive reason why the FluMist was responsible for these symptoms. HEPA filters were put into the environment and since then, nobody has gotten sick. The patient has recovered. The reporter believes military personnel that were vaccinated with FluMist were already sick and hence may have caused the individuals administering FluMist to have headache and scratch throat. The reporter determined the events to be unrelated to FluMist vaccination. Additional information received on Jan 05 2005 and Jan 19 2005 incorporated into above narrative. Additional information received on May 04 2005: patient name, gender and DOB, Vaccine lot number									Y					MIL	MIL					MEDI0002636	1						2	Headache; Medication error; Pharyngolaryngeal pain; Headache; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~500356P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500356P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0232082	08/09/2005		64.0			F	05/04/2005	This is a non serious spontaneous case from a healthcare professional in the USA reporting that a medical support member had accidental exposure (Unlabelled, USA) to FluMist while vaccinating military personnel. The reporter determined the events to be unrelated to FluMist administration. A 64 year old female medical support member developed headache and scratch throat after accidental exposure during FluMist administration. Investigation into there events resulted in no definitive reason why the FluMist was responsible for these symptoms. HEPA filters were put into the environment and since then, nobody has gotten sick. The patient has recovered. The reporter believes military personnel that were vaccinated with FluMist were already sick and hence may have caused the individuals administering FluMist to have headache and scratchy throat. The reporter determined the events to be unrelated to FluMist vaccination. Additional information received on Jan 05 2005 and Jan 19 2005 incorporated into above narrative. Additional information received on May 04 2005: patient name, gender and DOB, vaccine lot number									Y					MIL	MIL					MEDI0002637	1						2	Headache; Medication error; Pharyngolaryngeal pain; Headache; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~500356P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500356P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0232083	08/09/2005		34.0			M	05/04/2005	This is a non serious spontaneous case from a health care professional in the USA reporting that a medical support member had Accidental Exposure to FluMist while vaccinating military personnel. The reporter determined the events to be unrelated to FluMist administration. A 34 year old male medical support member developed headache and scratch throat after accidental exposure during FluMist administration. Investigation into these events resulted in no definitive reason why the FluMist was responsible for these symptoms. HEPA filters were put into the environment and since then, nobody has gotten sick. The patient has recovered. The reporter believes military personnel that were vaccinated with FluMist were already sick and hence may have caused the individuals administering FluMist to have headache and scratchy throat. The reporter determined the events to be unrelated to FluMist vaccination. Additional information received on Jan 05 2005 and Jan 19 2005 incorporated into above narrative. Additional information received on May 04 2005: patient name, gender and DOB, vaccine lot number									Y					MIL	MIL					MEDI0002638	1						2	Headache; Medication error; Pharyngolaryngeal pain; Headache; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~500356P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500356P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0233846	08/09/2005	VA	34.0	33		M	02/23/2005	MEDI 0002920 is not serious spontaneous case from a consumer or other non health professional in the USA of Runny Nose.The reporter causality is related to FluMist. This is a spontaneous case report sent by a consumer that refers to a male aged 33 years. He received FluMist on Feb 03 2005, the time was not recorded. On Feb 05 2005, the patient experienced a stuffed, runny nose, and cold symptoms. the time of onset was not reported. The reporter stated the events resolved in about a week. He used over the counter medicine for treatment and recovered. no further information available.										02/03/2005	02/05/2005	2		OTH	OTH					MEDI0002920	1						2	Pharyngitis; Pharyngolaryngeal pain; Rhinitis; Nasal congestion; Pharyngitis; Rhinitis; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500340P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0234627	08/09/2005	MI	24.0	24		F		This is a non serious case from a consumer in the USA involving nasal congestion. The reporter causality is not provided. A 24 year old female received FluMist on Jan 29 2005 and Experienced irritability, sneezing, runny nose for 2 days followed by 2 days of nasal congestion. it is unknown if the patient recovered from the reported symptoms. Reporter causality was not provided. Feb 28 2005 received additional information : demographics, vaccine date, events details and past med history. Oct 26, 2005 additional information added: patient's age and AE onset.									U	01/29/2005	01/30/2005	1		MIL	MIL	Concomitant Drug(s) not used.		Eustachian tube dysfunction; seasonal allergies;		MEDI0002817	1						2	Fatigue; Irritability; Nasal congestion; Rhinorrhoea; Sneezing; Irritability; Nasal congestion; Rhinorrhoea; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0234713	08/09/2005	UT	18.0	18		F		This is not serious case from a physician in the USA of Urticaria. The reported causality was not provided to FluMist. This is a spontaneous case report sent by a physician that refers to a female aged 18 years. She received FluMist on Feb 10 2005. The patients concomitant medication included drospirenone. The patient developed a flu like illness five days prior to FluMist vaccination. Sometime on Feb 15 2005 the patient developed an urticarial rash, On Feb 20 2005, she developed pain with walking and pain in many joints especially in her knees. She presented in the reporters office on Feb 24 2005 for initial consultation and was diagnosed with reactive arthritis. She received Toradol for treatment and ultra bet for pain. The reported stated he was not sure if the events were due to FluMist. Attempts to locate the vaccine facility and lot number have been unsuccessful. The reporter stated that the patient was lost to follow up. No further information is available. April 25 2005 additional information received from the reporter and incorporated in the narrative: Patients date of birth, confirmation that the reported vaccine facility was incorrect, and the patient was lost to follow up				Y					U	02/10/2005	02/15/2005	5		OTH	OTH	Yasmin	Flu like symptoms	Flu like illness 5 days prior to receiving FluMist		MEDI0002932	1						2	Arthralgia; Arthritis; Urticaria; Arthralgia; Arthritis; Influenza like illness; Pain; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Emergency room visit	Influenza
0242468	08/09/2005	VA	10.0			F	11/23/2004	The reporter causality is not provided to FLUMIST. A pharmacist reported loss of appetite, headach, severe myalgia, extreem malaise, low-grade fever, childs, and slight nasal congestion in a female patient after received a Flumist vaccination, This 10 year old female with a history of seasonal allergies received FluMist at the reporters pharmacy on Nov 12 2004. The reported onset date for the events was Nov 13 2004. The events continued for six days with the first four days more severe thatn the latter. The patient received acetaminophen and ibuprofen for treatment and recovered on Nov 18 2004									Y	11/12/2004	11/13/2004	1		OTH	OTH	Flonase, Clarinex	Seasonal allergy	Seasonal allergies		MEDI0002496	1						1	Anorexia; Chills; Headache; Hypersensitivity; Malaise; Myalgia; Nasal congestion; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500333P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0242469	08/09/2005	MI	49.8	49		M	12/06/2004	The reporter causality is not provided. Case reference MEDI-0002521 is a spontaneous case report sent by consumer which refers to male aged 49 years. The male received FluMist on Nov 23 2004 at 4pm. ON Nov 25 2004, the male stated he was achy all over and had a headache, By the following day the reporter stated he had the full blown flu. On Nov 26 2004 he had light chills that became worse by Nov 27 2004. He stated his chills were so severe on Nov 27 2004 that he had to wear a coat while indoors. He used ibuprofen for treatment. By Dec 02 2004 all events excluding loss of appetite had resolved. The reporter stated his appetite returned on Dec 05 2004.									Y	11/23/2004	11/25/2004	2		OTH	PVT					MEDI0002521	1						1	Anorexia; Chills; Headache; Influenza; Pain	FLUN3~MEDIMMUNE VACCINES, INC.~500337P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0242470	08/09/2005	IN	7.0	6		M		This is a non serious spontaneous case from a physician in the USA who reports a patient tested positive for influenza A (Labeled,USA). The reporter did not provide causality between events and FluMist vaccination. On Nov 11 2004, a 6 year old male received FluMist intranasally and developed fever, sore throat, and stomach ache on the morning of Mar 19 2005. He went to an urgent care facility where he initiated amoxicillin treatment. On Mar 21 2005, the patient visited the doctor where he complained of fever, runny nose, and red eyes. A nasal swab was taken and tested for Influenza A and B. The patient tested positive for influenza A and he discontinued amoxicillin. The patient has improved but has not yet recovered.									N	11/11/2004	03/19/2005	128	Mar 05 positive nasal swab for Influenza A	PVT	PVT	Adderall				MEDI0003081	1						1	Abdominal pain upper; Influenza; Ocular hyperaemia; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500336P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0242471	08/09/2005	VA				U	04/15/2005	The reporter determined that the symptoms were related to receipt of FluMist. A nurse at a military clinic reported that an adult patient received FluMist in January 2005. A few hours later, the patient experienced flu like symptoms. The reporter felt that the symptoms were related to FluMist but she did not think that it should be reported because it was an expected reaction. The patients demographic information was not recorded. It is also unknown if the patient recovered from the reported symptoms.									U					MIL	OTH					MEDI0003231	1						1	Influenza like illness	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0242472	08/09/2005	PA	43.0	43		F	05/09/2005	This is a non serious spontaneous case reported by a nurse in the USA of a 43 year old female who developed hives after receiving FluMist. The reported did not provide casual relationship to FluMist vaccine. A 43 year old female developed hives on both legs within 24 hours of receiving FluMist on Apr 12 2005. the patient had planned for a trip and decided to get the FluMist from a travel health office. Per the reporter, the patient proceeded with her travel plans even when the hives began to appear, However, she reported the event to the travel health office only upon coming back where she was advised to consult with her family physician. the patient is not allergic to eggs but claimed to be prone to skin sensitivity and getting sick easily. The patient did not report any doctor visits or hospitalizations related to this while she was abroad. She has not recovered from this event. The hives are resolving, but the sites were described as still tender and somewhat black and blue in color, Reporter causality was not provided.									N	04/12/2005	04/13/2005	1		PVT	PVT			NONE		MEDI0003367	1						1	Skin discolouration; Tenderness; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500340P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0242473	08/09/2005	NC	39.0	39		M	06/17/2005	MEDI-0003483 is a non serious spontaneous case from a consumer in USA involving flu like symptoms. The reporter causality is not provided to FluMist. A 40 year old male received FluMist on Oct 27 2004 at 1:48 pm. 3-4 days after receiving the vaccine, patient experienced nasal congestion. On the 6th day, the patient felt worse with more flu like symptoms and felt that he developed full blown influenza, He complained of chest congestion, cough, muscle aches, fever and nausea. The patient called his doctor to inform him of his symptoms. He was advised to stay home and rest. His doctor reported the symptoms he developed to the Center for Disease (CDC). After a month, the patient fully recovered. He was then seen at his doctors office where a nasal swab was taken but he did not know what the result was. Per nurse at doctors office, there was no record on patients chart that a nasal swab was done at their office. The reporter felt the events are possibly related to FluMist, although he stated that he was also doing some paint jobs a few days after he received FluMist. The patient fully recovered. Additional information incorporated in narrative. AE onset date.									Y	10/27/2004	10/30/2004	3	Nasal Swab results unknown.	PVT	PVT	Concomitant Drug(s) Not Reported.		Nasal swab-results unknown.		MEDI0003483	1						1	Cough; Influenza; Influenza like illness; Myalgia; Nasal congestion; Nausea; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500336P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0242475	08/09/2005	NY	37.0	36		M	11/23/2004	This is a not serious spontaneous case from a consumer other non health professional in the USA of Headache. The reporter causality is not provided to FluMist. A consumer reported headache, abdominal pain, 100 degree F temperature, vomiting, diarrhea, chills fatigue, muscle ache, and malaise in her husband three days after receiving the FluMist vaccine. The 37 year old male received FluMist on Nov 19 2004. On the Morning of Nov 22 2004, the patient awoke with a headache that became worse by the afternoon. He had chills severe fatigue that became worse in the evening. Later, on the evening of Nov 22 2004, he had general muscle aches, malaise, and abdominal pain. he began vomiting about 9:00 pm on Nov 22 2004. The reporter stated on Nov 23 2004, her husband felt a little better. He still had fatigue, minor diarrhea, and a mild headache. No further information is available.									N	11/19/2004	11/22/2004	3		OTH	PVT	Multi Vitamin				MEDI0002462	1						1	Abdominal pain; Chills; Diarrhoea; Fatigue; Headache; Malaise; Myalgia; Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500340P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0242476	08/09/2005	MD	33.0	33		F	11/22/2004	This is a non serious spontaneous case from a registered pharmacist in the USA who experience a Nose Bleed after receiving FluMist. The reporter did not provide causality between events and FluMist vaccination. At 9:45 am on Nov 10 2004, a 33 year old female received FluMist intranasally and experienced headache, runny nose, and slight fever on Nov 11 2004. On Nov 12 2004, the patient experienced nasal congestion and on the same day her runny nose resolved. The nasal congestion was unresponsive to Flonase (fluticasone propionate) and Deconsal (guaifenesin/pseudoephedrine). Her headache was treated with Tylenol (acetaminophen). On Nov 20 2004, the nasal congestion was on going. On the evening of Nov 20 2004, the patient experienced a severe nose bleed. She is scheduled for an ENT visit in Nov 24 2004. The patient has been using Ocean nasal (sodium chloride) nasal since Nov 11 2004. The reporter did not provide causality between events and FluMist vaccination.										11/10/2004	11/11/2004	1		OTH	OTH	Trimpex, Flonase, LO/Ovral, Ocean nasal spray		Penicillin Allergy		MEDI0002453	1						1	Epistaxis; Headache; Nasal congestion; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0242477	08/09/2005	OH	6.0	5		F	11/23/2004	This is not serious spontaneous case from a nurse in the USA involving Red Face. The reporter causality is not related to FluMist. A nurse reported a red face, runny nose, ear infection, and nasal congestion in female patient 1 day after receiving her FluMist vaccine. This 5 year old girl with a history of allergies presented in the reporters office on Nov 08 2004 with an ear infection. The patient received an intramuscular injection of ceftriaxone sodium for treatment of the ear infection and she received the FluMist vaccine. On Nov 23 200, the patient had a runny nose and nasal congestion. On Nov 15 2004, the infant presented in the reporters office with an ear infection. The patients runny nose had improved but her face was red from nose to her lip. The reporter stated she did not know if the patients face was red due to rubbing her face or if it was red due to the blowing of her nose. No further information is available.									N	11/08/2004	11/09/2004	1		PVT	PVT	Rocephin	Ear infection	Seasonal allergies (Rhinitis), Ear Infection Nov 08 2004		MEDI0002459	1						1	Erythema; Nasal congestion; Otitis media; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~50038P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0242666	08/10/2005	DC	50.0	50		F	12/26/2004	30 hours after vaccination pt noted raised red crash, hot and puffy with serious itch on upper left chest, neck and chin. Has taken 5 days to resolve without treatment.									Y	12/19/2004	12/20/2004	1		OTH	PUB		NONE	NONE			1						1	Feeling hot; Injection site erythema; Injection site oedema; Injection site swelling	FLU3~SANOFI PASTEUR~U1454AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0242816	08/11/2005	AZ	5.0			F	08/10/2005	Left upper arm, red, hot and swollen on 8/9/05. Seen 8/10/05, less swollen but itchy. Area 7x7.5cm red. Benadryl PO and Prelone syrup if not better 8/10/05.									U	08/08/2005	08/09/2005	1	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Feeling hot; Injection site erythema; Injection site oedema; Pruritus	FLU3~SANOFI PASTEUR~U1345CA~5~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1189~4~SC~~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0242838	08/12/2005	AR	35.0	34		F	12/20/2004	10/29/04 C/O site reaction and noted red edematous area where Flu shot given 10/28/04. States 1 week after site reaction had hive like ruddy rash from shoulders- ankles, follow by swelling of face, lips and hands. States went to ER and had injections. Follow by steriod dose pack.				Y					Y	10/28/2004	10/29/2004	1		OTH	OTH					AR0523	1						1	Injection site erythema; Oedema peripheral; Rash; Swelling face; Urticaria	FLU3~SANOFI PASTEUR~U1456AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0242839	08/12/2005	AR	46.0	45		F	01/26/2005	Began itchy, developed rash all over with a few hives that night and throat felt sick. Saw Dr. next day and was told she had an allergic reaction to the flu shot. Rx for medrol dose pack and visteril				Y					Y	01/25/2005	01/25/2005	0		PUB	UNK		Bronchitis- treated with antibiotic the week before	Migraines, IBS		AR0520	1						1	Pruritus; Rash; Urticaria; Vaccination complication	FLU3~SANOFI PASTEUR~U1521AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0243380	08/25/2005	TX	1.91	0	.9	F	07/01/2005	Acute transverse myelitis, optical neuropathy - loss of vision (impairment), demyelinating disorder (CNS) severe, myelopathy. Per follow up report-Neurological symptoms that has been ongoing for the past three years as of 10-31-05.  Patient didn't have this conditon before the shot was given.			Y	Y	Y	1	Y	Y	N	10/31/2002	11/01/2003	366	Yes	PVT	UNK	NONE	NONE	NONE			1						1	Blindness; Demyelination; Myelitis transverse; Myelopathy; Neurological symptom	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0243438	08/26/2005	NC	41.0	40		M	08/24/2005	Migraines, polyarthralgias, persistent nausea with onset following receipt of multiple vaccines.  41 year old male with concerns about a decline in his health following receipt of multiple vaccines prior to his deployment in 2004.  Patient reports new onset migraines, persistent nausea, and joint pain.  Prior to deployment was healthy, with no activity restrictions or other limitations due to health problems.  He is currently undergoing a medical board evaluation.  On 05/03/2004 - not sure what arm he received immunizations.  Does not recall significant swelling, redness, or itching surrounding vaccine sites.  Recalls some tenderness at vaccination sites lasting about 1 week.  About 24-48 hours after vaccine receipt, recalls that it felt like he was getting the flu and began treating with over the counter medications.  (He thinks he took Tylenol Cold and Flu tablets.)  Symptoms included tiredness, felt weak, nauseated with decreased appetite, and generalized body aches.  He does not recall experiencing a fever or chills.  Most of these symptoms gradually improved.  After about 3 weeks from onset, he felt like he was functioning better.  At the time, he attributed the symptoms to the flu or jet lag and adjusting to his new environment.  At the end of May, he continued to experience nausea.  During the flight to Germany on 05/05/2004, patient experienced a severe headache, primarily manifested as severe pressure on the right side of his head.  The flight personnel broke an ammonia inhaler to help relieve the pressure; he recalls it helped him to tolerate the remainder of the flight.  He does not recall a recurrence of the severe headaches, until about 3 months following his initial episode.  Then, he started having severe headaches about 4 times per month.  At that time, he related the headaches to increased stress and being tense and on the edge and he thought they would resolve.  During the first week following vaccine receipt, patient reports that his eyes were really red and itchy with increased tearing; he self treated with Visine, but the next week, the symptoms were getting worse.  He then sought medical evaluation and was seen at the eye clinic.  He recalls that they did  cultures and gave him a prescription for eye drops and ointment for 1 week; within a few days of initiating treatment, his symptoms started clearing; they were completely resolved by 1 1/2 weeks.  Around July 2004, which was about 2 months post-vaccine receipt, patient started experiencing joint pain in his ankles, hands, elbows, and neck.  He sprained his left ankle in July 2004.  Initially, the pain was most prominent in the neck.  Around Mid-July or August, he started having lower back pain with associated symptoms of shooting pains and spasms down his legs, and numbness and buring sensation in his thighs and feet.  He had problems with his right leg dragging and would slip and slide.  He says he almost had bladder incontinence.  His evaluations ruled out Multiple Sclerosis.  In October 2004, his x-rays showed L4-5 degenerative disc disease and his MRI in October, showed multilevel degenerative disc disease of thoracic and lumbo-sacral spine.  Currently, his ankle pain varies in intensity.  On bad days it is hard to walk.  Most recently, he has also developed pain in his upper back, around kidney area on both sides described as aching pain.				Y					N	05/03/2004				MIL	MIL	HCTZ	NONE	Hypertension			1						1	Arthralgia; Asthenia; Decreased appetite; Fatigue; Migraine; Nausea; Pain	FLU3~SANOFI PASTEUR~C12600AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~UNKNOWN MANUFACTURER~794A6~UNK~~~HEP A (NO BRAND NAME)~1|IPV~SANOFI PASTEUR~W07502~UNK~~~POLIO VIRUS, INACT. (IPOL)~1|MEN~SANOFI PASTEUR~UE110AA~UNK~~~MENINGOCOCCAL (MENOMUNE)~1|MMR~MERCK & CO. INC.~0134N~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|TD~AVENTIS PASTEUR~U1011AA~UNK~~~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0243576	08/30/2005	GA	65.0	65		F	01/29/2005	Lump located on left arm, small redden lump, no pain at site or soreness, seen in PC advised to return if not well in 2 wks. Pt did not return.				Y					Y	12/13/2004	12/13/2004	0		PUB	PUB					GA05022	1						1	Injection site erythema; Injection site nodule	FLU3~SANOFI PASTEUR~U1553AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0243764	09/02/2005	IL	62.0	62		F	08/30/2005	Began with tiredness, trouble sleeping, weakness. then heart palpitation nearly blacking out. Breathing problems. Various severe momentary pains, different areas mainly left side of body. Then severe twitching in hand and leg, left side, lasting for hrs. Left me with tremors inside of body, numbness in leg and arm, temporary paralysis in 2 fingers, right side, etc, etc. Still am dealing with some of these symptoms although they are much less severe then they were. Still experiencing tics and tremors constantly though less in intensity, still tire easily.				Y					Y	01/12/2005			Computer Tomography Scan of cervical spine (MRI), Computer Tomography scan of neck with contrast, MRI of brain with and without contrast, MRI of cervical spine with and without contrast, Echocardiogram, Upper endoscopy, numerous blood tests, Urine test, Neurological tests, 24 Hr heart monitor, CT scan lungs, Kidney ultrasound, Emergency room Paresthesias, ENT inspection of Larynx, Esophagram, Immunologist consultation (concluded it was caused by flu shot.	PVT	PVT	Nasonex nasal spray, Premarin vaginal cream, Protonix	NONE	No allergies. Birth defect (I was born with a Dermoid type of thing on my left eye. Had surgery to correct.			1						1	Asthenia; Cardiac disorder; Dizziness; Fatigue; Hypoaesthesia; Insomnia; Muscle twitching; Pain; Palpitations; Paralysis; Respiratory disorder; Tic; Tremor	FLU3~SANOFI PASTEUR~U1443AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0243805	09/06/2005	MI	49.0	48		F	10/15/2004	Patient had developed hives, general body swelling, itching and swelling of lips and face less than 24 hours after receiving flu vaccine intramuscularly.  Instructed to use cool soda baths for itching and also was given a shot of 40gm Depo Medrol and was given Medrol Dosepak.  Patient is to return as needed.				Y					U	10/12/2004	10/13/2004	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Pruritus; Swelling face; Urticaria	FLU3~SANOFI PASTEUR~U1438AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0243947	09/09/2005	MO	1.1	1	.1	F	09/08/2005	Pt received Varivax vaccine on 01/19/2005 and was diagnosed with chicken pox on 09/08/2005. (mild case of Chicken Pox).									U	01/19/2005	09/07/2005	231		PVT	PVT	Amoxicillin	Resolving Ear Infection				1						1	Viral infection	FLU3~SANOFI PASTEUR~01450AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0767D~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0767D~UNK~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0231415	09/16/2005	NY	38.0	38		F	09/13/2005	From initial information received on 23Dec04 from a health care professional regarding an adverse event occurring, it was reported that a 38 yr old female pt received a dose of Fluzone SV 2004-2005 USP, lot number U1523AA, with an expiration date of 30Jun05, administered in the left deltoid on 06Nov04 at 11:00AM. The route of administration was not reported. Two days later, on 09Nov04 at 10:00AM, the pt developed bilateral leg pain. In was suggested by the reporter that the pt is seen for a neurologist consultation, which was scheduled for 14Jan05. Reportedly, the pt did not recover from this events and is under physician's care. Follow up information received on 08Sep05 from a health care professional. It was reported that the pt experienced bilateral leg paresthesia and was referred to a neurologist. An x-ray of the lumbar spine was performed on 30Nov04 and an MRI of the brain on 15Dec04, but no results were provided. The pt lost time at work, but is reportedly is doing well now. It was not reported whether she completely recovered from the events. Based upon the new information provided, this case is being upgraded to serious. (OMIC)				Y					U	11/06/2004	11/08/2004	2	MRI, EEG and CBC were obtained. CBC was 5.5. The pt was told that all tests were within normal limits. From additional information received on 08Sep05, it was reported that the pt had an x-ray of the lumbar spine on 30Nov04 and an MRI of the brain on 15Dec04. No results were provided.	OTH	UNK	Bextra, Flexeril		The pt has occasional back spasms. She had no illnesses at the time of vaccination. From additional information received on 08Sep05, it was reported that the pt has not experienced any adverse events following prior vaccination.		200404017	1						2	Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U1523AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0231530	09/16/2005	MI	86.0	85		M	09/14/2005	From initial information received on Mar 16 2004 from a physicians office, regarding an adverse event, It was reported that an 85 year old male patient received Fluzone SV 2003-2004 USP, lot number U1131AA, administered intra muscularly in the left deltoid on Nov 10 2003. The patient had no reaction at the time of vaccination. He visited his physician for a regular office visit on Dec 31 2003 and had no complaints. On Jan 02 2004, he was seen in the ER for bilateral leg and arm weakness. this was his second visit to the ER, but no details were provided regarding his first visit. He was admitted to the hospital on Jan 02 2004 and was diagnosed with Guillain Barre syndrome. The patients recovery status is unknown. From additional information received on May 28 2004 from a physician, the patients hospital records were provided. The patient was admitted to the hospital on Jan 02 2004 with a three to four day history of progressive arm and leg weakness to the point where he had to walk with a cane and felt like he could fall when he was ambulating. Vital signs were stable on admission. Upon initial exam, the patient appeared weak and had difficulty getting out of bed. He was unable to push himself into a sitting position using his arms. His lower extremities appeared to be areflexic. He had a slightly positive Babinski. Romberg testing was negative. Pronator drift testing was also negative. His gait was watched without ataxia. Cerebellar testing of the lower extremities was normal. The patient denied concurrent fever, shortness or breath, coughing, muscle fasciculations or numbness or tingling of the hands or feet. He also denied exposure to botulism. Reportedly, the patient had not had any tick bites or traveled recently, A CAT scan of the brain on Jan 02 2004 revealed chronic findings with no acute anomaly identified. The patients recovery status was not reported. Follow up information received on Sept 12 2005. It was reported that the patient has recovered from these events. No further information is expected.				Y	Y				Y	11/10/2003	01/02/2004	53	Urinology, EEG, CBC, SMA12.CDC. CK, troponin, CT of brain, and neurological examinations were performed, however, no results were provided at the time of this report. His pulse oximetry was 94, blood pressure 130/75, pulse 90 and respirations 18. CT of the brain completed on Jan 02 2004 revealed chronic findings with no acute anomaly identified. Chest PA and lateral also completed on Jan 02 2004 revealed an apparently new right lobe nodule with stable left mid long nodule. Atherosclerosis and chronic basilar atelectasis were noted with no other acute findings. Laboratory testing completed on Jan 02 2004 included the following,: Urinalysis- urine spec gravity elevated at 1.025, urine ketones-trace (normal : negative), CBC: RBC low at 4.20x10^6/UL, Hemoglobin low at 13.0g/dl, Hematocrit low at 37.6%, Neutrophils elevated at 65.1%, Lymphocytes low at 1.4x10^3/ul. Influenza A/B antigen was negative. RA latex completed on 01/03/2004 was negative. HIV antibody screen completed on 01/04/2004 was negative. Mono screen, Hepatitis C antibody CR and ANA ANF completed on 01/05/2004 were negative/ EB Virus VCA-IGM, Hepatitis B antibody and Hepatitis B antigen completed on 01/06/2004 were negative. EB virus VGA-IGG test was positive at 242 (positive range >20). CMV antibody collected on Jan 08 2004 was negative. Lyme screen IGG/IGM completed on Jan 13 2004 was negative. Hepatitis A antibody HV was positive.	UNK	UNK	Aspirin, Flomax, Nyquil		The pt had previously received influenza vaccines in 1999 and 2001. His pre-existing medical conditions included coronary artery disease with angioplasty x1 and benign prostatic hypertrophy. Past surgical history was positive for hernia repair. The pt had no known allergies.		200401021	1						2	Asthenia; Atelectasis; Atherosclerosis; Extensor plantar response; Gait disturbance; Guillain-Barre syndrome; Haemoglobin decreased; Hypokinesia; Hyporeflexia; Laboratory test abnormal; Lymphopenia; Red blood cell count decreased; Skin nodule; Urine analysis abnormal	FLU3~SANOFI PASTEUR~U1131AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0244212	09/16/2005	MD	58.0	58		F	09/16/2005	The morning after the innoculations I had a headache, sore muscles, pain and swelling at the injection site, and a fever. The fever reached a maximum of 103.4 at 5:30 PM on June 9,2005.  Tylenol and Ibuprufen were taken to reduce the fever.  A course of Cephalexin was started at 11:30 PM on June 10.  Temperature returned to normal by the morning of June 11.  The headache and sore muscles had subsided by that time, as well.  The injection site on the right arm was still sore and red (3 inches in diameter) for more than 2 weeks.									Y	06/08/2005	06/09/2005	1		UNK	UNK	No medications Multiple vitamin Calcium Fish oil	None	None			1						1	Headache; Injection site pain; Injection site swelling; Myalgia; Pyrexia; Vasodilation procedure	FLU3~SANOFI PASTEUR~U1530AB~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB029AB~1~~RA~HEP A + HEP B (TWINRIX)~1|IPV~SANOFI PASTEUR~X0313~UNK~~LA~POLIO VIRUS, INACT. (IPOL)~1|PPV~UNKNOWN MANUFACTURER~0486P~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0244371	09/20/2005	CA	65.0	64		F	09/20/2005	About 3 hours later started feeling nausea then vomiting. Inside of mouth, below tongue, behind lower teeth was swollen . Vomiting continued for about 2-3 hours. Overnight there was some discharge from the eyes resulting in crusty in AM.									Y	09/19/2005	09/19/2005	0		UNK	UNK	high blood pressure pill	none	high blood pressure			1						1	Eye discharge; Nausea; Oedema; Vomiting	FLU3~SANOFI PASTEUR~U1772AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0244399	09/21/2005	VA	0.51	0	.5	F	09/21/2005	Hives appeared one hour after administration of flu vaccine.  Started at neck and spread to torso, arms, legs, chin, around lips, ears.  Benadryl every 6 hours administered for 24 hours.				Y					Y	09/21/2005	09/21/2005	0		UNK	UNK		NONE	NONE`			1						1	Urticaria	DTAP~SANOFI PASTEUR~C2220AA207~3~IM~UN~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~41792AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0807P~3~IM~UN~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~A25964H~3~IM~UN~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0244462	09/22/2005	WV	85.0	84		F	09/22/2005	On 09/21/2005 patient phoned office, advised that her arm was sore and swollen and had a knot and was puffed up, no redness, not warm to touch, states felt like I had the flu for a few days.  Still feels tired, had no fever but was chilled and had sweats.									Y	09/13/2005	09/14/2005	1	NONE	PVT	PVT	Metaprolol mg, Tiazac, Enablex, Meprobamate, Lexapro , Ultracet, Allopurinol, Darvocet, Centrum, Vitamin B12 injection every 1-2 weeks.	Severe Osteoarthritis	Allergy to penicillin, sulfa, codeine, Elavil, Clarinex, Triavil, and Ilosone.  Has hypertension, gout, anxiety-depression, hyperactive urinary bladder, severe osteoarthritis, b-12 anemia.			1						1	Influenza like illness; Pain; Swelling	FLU3~SANOFI PASTEUR~U1775AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0244505	09/23/2005	IL	50.0	50		F	09/23/2005	Client reports that she has received the flu vaccine for the past 5 years. Other than the flu vaccine the only other vaccine that she has received was a Td booster given by our Health Dept on 7/31/03.  3 weeks after she received the flu vaccine last year she developed redness, itching, puffiness of her eyelids.  She also complained of a irritated throat and a dry cough. She sought medical attention as these symptoms persisted.  She finally saw a dermatologist on 9/20/05 for a patch test and received the results today showing a high sensitivity to thimerosal. She called today to report this and ask about the duration of this in her system. I gave her the telephone number for CDC and manufacturer.				Y					N	10/02/2004	10/23/2004	21	Positive patch test for thimerosal.	UNK	UNK	none	none	none			1						1	Cough; Eyelid oedema; Hypersensitivity; Injection site erythema; Laboratory test abnormal; Pharyngolaryngeal pain; Pruritus	FLUX~UNKNOWN MANUFACTURER~~5~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0244569	09/26/2005	ND	25.0	25		M	09/26/2005	PREVIOUS HISTORY - SEVERE ALLERGIC/ADVERSE REACTION TO ANTHRAX VACCINE IN JUNE 2004, LOST FEELING IN HANDS, LOST SKIN ON HANDS, SORE LIMBS, FATIGUE. VAERS INVESTIGATION COMPLETED, RECOMMENDATION FOR NO MORE ANTHRAX VACCINATIONS.  EXEMPTION SIGNED BY MEDICAL DIRECTOR. HOSPTIAL WANTED TO DO PATCH TESTING WITH THE ANTHRAX VACCINE, AND MY SQUADRON COMMANDER SAID NO, BECAUSE MY COMMANDER WAS NOT GOING TO RELEASE ME TO BE A MEDICAL GUINNY PIG. MEDICAL GROUP EXEMPTED ME FROM ANTHRAX WITHOUT FURTHER TESTING.  FURTHERMORE, IT WAS UNKNOWN WHAT FUTURE MEDICAL PROBLEMS I WOULD HAVE ASSOCIATED WITH THE PROBLEMS CAUSED BY ANTHRAX VACCINE. ALSO, IT WAS UNKNOWN WHAT PROBLEMS I WOULD HAVE WITH ANY FUTURE VACCINATIONS OTHER THAN ANTHRAX. WHEN ASKED PRIOR TO DEPLOYING, HOME STATION MEDICAL DOCTOR DID NOT KNOW WHAT AFFECT OTHER VACCINATIONS WOULD HAVE. ON SEPT 26, 2005, I RECEIVED MY FIRST VACCINATION SINCE HAVING THE ANTHRAX VACCINATON.  I RECEIVED A FLU SHOT.  I'VE NEVER HAD ANY PROBLEMS WITH ANY OTHER VACCINATIONS TO INCLUDE THE FLU SHOT PRIOR TO THE ANTHRAX VACCINE INCIDENT.  APPROXIMITELY 15 MINUTES AFTER HAVING THE FLU SHOT, FELT BURNING SENSATION WITH PAIN 7 OUT OF 10, SIMILAR TO ANTHRAX SHOT BURN.  2 HOURS LATER, WENT TO EMEDS, AND DOCTOR COULD NOT EXPLAIN CAUSE. BURNING SENSATION 2 HOURS LATER WAS A 5 OUT OF 10. I HAVE NO FOOD/DRUG ALLERGIES. I INFORMED DOC OF PREVIOUS HISTORY WITH ANTHRAX VACCINATION, AND THE DOCTOR TRIED PURSUADING THAT ANTHRAX WAS SAFE AND DOES NOT CAUSE PROBLEMS WITH OTHER VACCINATIONS. OBVIOUSLY THE DOCTOR WAS NOT LISTENING WHEN I EXPLAINED MY PREVIOUS CASE HISTORY. THE DOCTOR OFFERED BENADRYL AND I DECLINED IT AS I FELT IT WOULD BE OF NO HELP. I BELIEVE THAT MY ANTHRAX VACCINE MESSED UP MY IMMUNE SYSTEM (NO HEALTH TESTS WERE EVER COMPLETED FOR MY EXEMPTION, EVEN THOUGH MEDICAL RECORDS STATE POSSIBLE IMMUNE/NEUROLOGICAL DAMAGE), SEEING HOW THE FLU SHOT WAS A TRIAL AND ERROR SHOT TO SEE WHAT WOULD HAPPEN, THE AFFECTS ARE EVIDENT. ITS NOW 7 HOURS AFTER RECEIVING THE SHOT, AND THE BURNING IS STILL A 5 OUT OF 10. THE EMEDS DOCTOR WANTED ME TO RETURN IF THE CONDITION PERSISTED, AND DID NOT WANT ME TO FILE A VAERS REPORT. I FOUND NO HELP AT EMEDS WHEN I WENT THE FIRST TIME, AND WILL I WILL NOT RETURN TO EMEDS. I INFORMED MY CHAIN OF COMMAND HERE OF MY CASE HISTORY, AND THEY RECOMMENDED I FILE THIS REPORT. MY CHAIN OF COMMAND IS MONITORING ME TO MAKE SURE I DON'T BECOME INCAPACITATED. IT IS EVIDENT FUTURE HEALTH VACCINATIONS ARE DETERIORATING TO MY HEALTH CAUSED BY UNKNOWN HEALTH PROBLEMS ASSOCIATED WITH MY ANTHRAX PROBLEMS. I AM DEPLOYED AND SUPPOSED TO RETURN IN MID JANUARY.  TO CONTACT ME, PLEASE EMAIL AS I CAN CHECK THAT EMAIL FROM ANY COMPUTER.				Y					N	09/26/2005	09/26/2005	0		MIL	OTH	NONE	NONE	-ANTHRAX ADVERSE REACTION, NO ALLERGIES -NO BIRTH DEFECTS -EPIDYMAL CYST REMOVED, SEPTEMBER 2003 -WISDOM TEETH REMOVED - DATE UNKNOWN -TONSILLECTOMY - APRIL 2004	ANTHRAX~Anthrax (Biothrax)~3~0.00~Patient		1						1	Fatigue; Pain; Skin exfoliation; Thermal burn	FLUX~UNKNOWN MANUFACTURER~~2~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0244629	09/28/2005	OR	63.0	62		M	09/21/2005	Patient had severe immobility, soreness in vaccinated arm.  Had blood pressure 172-178/114, quite hypertensive, several readings.  Patient felt tired, diaphoretic for 48 hours - 96 hours after injection.									N	09/16/2005	09/16/2005	0	Blood pressure readings: 155/106, 177/114, 159/101, 176/104.	OTH	PVT	Cozaar.  Patient stopped ASA, Ibuprofen	Hypertension	NONE			1						1	Fatigue; Hyperhidrosis; Hypertension; Movement disorder; Pain	FLU3~SANOFI PASTEUR~U1805AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0605R~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0244630	09/28/2005	NC	6.0	5		F	09/23/2005	Patient received Flumist vaccine, 11:30AM-Noon on 09/20/2005.  Work up at 01:00AM (12 hours later) 09/21/2005 with hives, joint pain, fever of 103-104, rash, achy joints, and lip swelling.  Treated with Benadryl and Motrin with noted improvement.				Y					Y	09/20/2005	09/21/2005	1	NONE	PVT	PVT	Vigamox, Amoxicillin	Strep throat	NO			1						1	Arthralgia; Pyrexia; Rash; Swelling face; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500389P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0244632	09/28/2005	SC	2.0	2	.3	M	09/22/2005	Child had received flu vaccine on 09/20/2005.  Approximately 10 minutes later Mom noticed heavy breathing which progressed to severe audible wheezing.  He was treated with bronchodilaters in the nebulizer machine and was seen on 09/21/2005 in doctor's office.  He was then given orapred, pulmacort, and xapenex.  He was referred to the allergist as well.				Y					Y	09/20/2005	09/20/2005	0	NONE	PVT	PVT	Pulmicort, xopenex, orapred	NONE	GERD, RAD			1						1	Dyspnoea; Wheezing	FLU3~SANOFI PASTEUR~U1846AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0244697	09/28/2005	TX	81.0			U		Swelling, warmth, redness 2 inches under injection site.									Y					OTH	PVT						1						1	Feeling hot; Injection site hypersensitivity; Injection site oedema	FLU3~SANOFI PASTEUR~U1806AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0244700	09/29/2005	WV	69.0	68		F	09/28/2005	On 09/23/2005 at 1500 began shaking all over with chills, and headache, cried with pain, stated hurt all over, no local redness or warmth, afebrile, denied nausea, vomiting or diarrhea, stated spent two days in bed. Since 09/25/2005 continues to feel weak, and had no appetite, but is better.									Y	09/21/2005	09/23/2005	2	NONE	PVT	PVT	Valium, Nexium, Relafen, Actonel, Darvocet, and Nasonex spray.	NONE	Pre existing medical diagnoses included rheumatoid arthritis, osteoarthritis, fibromyalgia, hypertension, GERD, inhalant allergies and lipid disorder.			1						1	Anorexia; Asthenia; Chills; Crying; Headache; Pain	FLU3~SANOFI PASTEUR~U1775AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0244701	09/29/2005	MA	32.0	31		F	09/23/2005	Erythema, swelling, site of influenza immunization given 09/21/2005, reported 09/23/2005.									U	09/21/2005	09/22/2005	1		PUB	PVT						1						1	Injection site erythema; Injection site oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA122AB~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0244747	09/30/2005	CO	7.0	7		M	11/28/2003	10/18 got flu shot, next few days, increasing redness. 10/21 mom saw 1st time max tenderness, 4 oval concentric circles on thigh, 1 central knot/nodule seen in clinic 10/22 slight decreased erythema, limping. 10/23 resolving with itch.				Y					Y	10/18/2003	10/21/2003	3	s/p heart transplant, on Cellcept, Neoral, Lasix.	PVT	PVT	Cellcept, Neoral, Lasix	NONE	Heart transplant			1						1	Cardiac disorder; Erythema; Gait disturbance; Injection site erythema; Injection site mass; Tenderness	FLU3~SANOFI PASTEUR~U11034BA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0244748	09/30/2005	OH	1.04	1	.0	M	09/22/2005	Erythematous, discrete, papular areas along hairline, in scalp, neck, axillae and inguinal areas as well as trunk and extremities.									Y	09/17/2005	09/18/2005	1		PVT	PVT						1						1	Erythema; Rash papular	FLU3~SANOFI PASTEUR~U1777AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0212R~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0244749	09/30/2005	NY	1.57	1	.6	M	09/26/2005	Urticarial rash noted on exam in office 9/24/05, no involvement of palms and soles. Rash diffuse pustular 9/26/05, older lesions purpuric, newer lesions urticarial, erythema multiforme. No arthralgias, arthritis or fever.				Y						09/22/2005	09/23/2005	1	NONE	PVT	PVT	NONE	Resolving URI/coughing	NONE			1						1	Erythema multiforme; Purpura; Rash pustular; Urticaria	FLU3~SANOFI PASTEUR~U1743HA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0244750	09/30/2005	OK	40.0			F	09/28/2005	Reported dizziness, nausea and emesis 2 hrs after vaccine administered.				Y					Y	09/28/2005	09/28/2005	0		PVT	PVT	NONE	NONE	NONE			1						1	Dizziness; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U1756AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0244774	09/30/2005	RI	28.0			F	09/29/2005	Burning, aching mid of neck and chest, lower back. Per annual report-Achy run down, burning recurred in throat, chest, low back									Y					PVT	UNK	Synthrop, Zyrtec, Zantac, Rhinocort	NONE	Seasonal allergies			1						1	Back pain; Chest pain; Myalgia; Neck pain; Skin burning sensation	FLU3~SANOFI PASTEUR~U1747AA~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0244783	10/01/2005	TX	63.0	62		F	10/01/2005	Redness of skin and swelling in arm where vaccine was given. Also hurt to move arm.									N	09/29/2005	09/29/2005	0	N/A	UNK	UNK	None	None	N/A			1						1	Injection site erythema; Injection site swelling; Pain	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0244797	10/03/2005	NV	52.0	51		F	09/27/2005	Swollen lips, tightness, numbness (Left side face and Left side of body) tocal seizure.					Y	4			Y	09/12/2005	09/13/2005	1	Pt admitted, neuro work ups (i.e EEG, MRI brain, carotid doppler, TCA, echocardiogram) all negative.  Medical records state hyperchromic anemia. msv	PVT	PVT	Lotrel 10/20mg	NONE	Hypertension; bronchitis, Anemia Medical records state eye disease, perepherial neuritis. msv			1						1	Convulsion; Face oedema; Hyperchromic anaemia; Hypoaesthesia	FLU3~SANOFI PASTEUR~U1772AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0244801	10/03/2005	TX	6.0	6		M	02/18/2005	Left arm red and warm 10x12cm.									Y	02/16/2005	02/16/2005	0	NONE	PUB	PUB		NONE	NONE			1						1	Feeling hot; Injection site erythema	FLU3~SANOFI PASTEUR~U1459AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0244802	10/03/2005	AL	1.02	1	.0	F	10/03/2005	Papular rash to face, arms and legs.										09/30/2005	10/02/2005	2		PVT	PVT		NONE	NONE			1						1	Rash papular	FLU3~SANOFI PASTEUR~U1773AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0470P~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A85856B~4~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0244834	10/03/2005	GA	26.0	25		F	10/03/2005	Fever, arm swelling, rash, moderate-severe arm pain, body aches.									U	09/30/2005	10/01/2005	1		UNK	UNK	Pt took Benadryl, Zyrtec, and Ibuprofen	none				1						1	Pain; Pyrexia; Rash; Swelling	FLU3~SANOFI PASTEUR~u1778aa~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749p~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0244835	10/03/2005	GA	37.0	37		F	10/03/2005	Fever, trunk rash.									U	09/30/2005	10/01/2005	1		UNK	UNK	none	none	none			1						1	Pyrexia; Rash	FLU3~SANOFI PASTEUR~u1778aa~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749p~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0244872	10/04/2005	PR	39.0	38		M	08/10/2005	Red and itchy rash on some parts of the body for seven thru eleven days. No treatment just Mupirocin (Bactroban) 2% oint, Clindamycin (Cleocin T) 1% and Triamcinolone Ace 0.1% and until rash dries.										05/12/2003	05/10/2005	729		MIL	MIL		NONE	NONE			1						1	Injection site erythema; Injection site rash; Pruritus	ANTH~EMERGENT BIOSOLUTIONS~~UNK~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~4~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~~2~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0244880	10/04/2005	CO	60.0	60		F	10/03/2005	Gradual onset of swelling of right arm with decreased ROM (significant) for 24-36 hours. 4x5 inch area of redness at inject site right arm. Additional symptoms include swelling of stomach, hives on scalp, nausea, fever, pressure behind eyes, HA, pain in joints. Treated with Tylenol and Benadryl. Improved but not recovered.									N	10/01/2005	10/01/2005	0		OTH	OTH	Temazepam; Robaxin; Atenolol	NONE	HBP-mild; Splenectomy/Back injury S/P auto accident; Allergies: Iodine, Sulfa, PCN, Myocins, Niacin, Lotesin, various preservatives, milk, soy.			1						1	Abdominal distension; Arthralgia; Headache; Injection site erythema; Joint range of motion decreased; Nausea; Pyrexia; Sensation of pressure; Swelling; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~4~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0244947	10/05/2005	MI	0.5	0	.5	M	09/30/2005	Menactra given Pt should have been given Prevnar. No adverse reaction reported. No treatment needed.									Y	09/29/2005				PVT	PVT						1						1	Medication error	DTAP~SANOFI PASTEUR~C2277AA~3~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1753AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE336AA~3~IM~RL~HIB (ACTHIB)~1|MNQ~SANOFI PASTEUR~U1780AA~1~IM~LL~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0244948	10/05/2005	MN	58.0	57		F	09/27/2005	Patient received influenza vaccine at approximately 1:00pm 09/26/2005. She called the clinic 24 hrs later to report a rash on the trunk of her body, under breast and on belly. Rash does not itch. No other symptoms reported. Called 09/29/2005 rash gone.									Y	09/26/2005	09/27/2005	1		PVT	PVT	Avonex 30 mcg P35024 IM LD, Levothyroxin, Albuterol sulfate, albuterol inhaler, Advair diskus, Singulair, Diovan, Furosemide, Potassium chloride, Nexium, Estradiol, Triamcinolone CRE, Baby aspirin, Denavir CRE, Lomotil, Calcium carbonate Vi	NONE	Sulfa			1						1	Rash	FLU3~SANOFI PASTEUR~U1756AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0244959	10/05/2005	VA	60.0	59		F	10/05/2005	Evening after shot and day after shot developed hives where pneumonia shot was given and all down arm to elbow.  Also tremendous soreness in arm and feeling like I had a virus.									Y	10/03/2005	10/03/2005	0	none	UNK	UNK	Allegra D, Topamax, Singular, Arthrotec	none	asthma, chronic bronchitis			1						1	Pain; Urticaria	FLU3~SANOFI PASTEUR~41778AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~ot49p~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0244968	10/05/2005	CA	72.0	71		M	10/05/2005	Nausea, Vomiting and diarrhea starting 18 hours after shot.									U	10/04/2005	10/05/2005	1		UNK	UNK						1						1	Diarrhoea; Nausea; Vomiting	FLU3~SANOFI PASTEUR~u1771aa~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0244970	10/05/2005	LA	38.0	37		F	10/05/2005	Received a Fluzone Influenza Virus Vaccine between 8-9:00am on 10-4-05.  At 2:00pm she developed fever (not measured), lethargy, tired, achy symptoms.  Did not sleep well.  Facial flushing.  She began taking ibuprofen every 6hrs. for symptoms.  On 10-5-05, continued having symptoms.  By 3pm, was feeling better, symptoms resolving.									Y	10/04/2005	10/04/2005	0		UNK	UNK	None	None	Emycin			1						1	Fatigue; Flushing; Lethargy; Pain; Pyrexia; Sleep disorder	FLU3~SANOFI PASTEUR~U1756AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U1596AA~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0155418	10/06/2005	TX	21.0			U	10/04/2005	It was reported that a patient 1 of 2) received a Menomune A/C/Y/W-135, A TD adult, a Flu (unspecified) vaccination and a PPD Tubersol skin test during the time of Jun 8 and Jun 10 2000 exact date not specified. Reportedly sometime after the immunization the patient developed Guillain Barre syndrome. Further information requested. On Sept 6 2000, additional correspondence was received from the responsible physician, no additional information was provided. From additional information received on 10/08/2004 from a physician, it was reported that the original reporting physician and retired from the facility shortly after reporting this case in 2000, The physician who replaced the reporter at the facility checked his database in an attempt to locate more information for this case, but was unable to locate any information for this patient, who remains unidentified. No further information is anticipated, this case is considered closed. From follow up information received on Sept 26 2005. Case received from VAERS extraction for the period from 1991 to 2005, and linked to nine other cases. Based on medical information this case had been upgraded to Serious. It was reported that the patient was 21 years old. Date of vaccination was 05/12/2000. The patient developed a fever, chills and sore throat on Jun 08 2000. Onset of weakness in the hands and legs began on Jun 11 2000, 30 days post immunization. The patient was admitted to the hospital on Jun 14 2000 and was treated with IVIG. The patient reportedly was diagnosed with Guillain Barre syndrome. At the time of this report received on Jun 27 2000 by VAERS the patient was still hospitalizes. No further information expected. The VAERS number 155418 was provided for this case. Other nine cases received are U200000491, 200401816, 200501908, 200501909, 200501910, 200509111, 200501912, 200501913, 200501914.					Y				U	05/12/2000	06/11/2000	30		UNK	UNK	PPD				U200000490	1						2	Asthenia; Chills; Guillain-Barre syndrome; Pharyngolaryngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|MEN~SANOFI PASTEUR~UA170AA~UNK~~UN~MENINGOCOCCAL (MENOMUNE)~2|TD~AVENTIS PASTEUR~UNK~UNK~~UN~TETANUS DIPHTHERIA (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0155420	10/06/2005	TX	19.0			U	10/04/2005	It was reported that a patient 2 of 2) received a Menomune, A TD adult, a Flu (Unspecified) vaccination and a PPD Tubersol skin test during the time of Jun 08 and Jan 10 2000 exact date not specified. reportedly sometime after the immunizations the patient developed Guillain Barre syndrome. Further information requested. On Sept 6 2000, additional correspondence was received from the responsible physician, no additional information was provided. From additional information received on Oct 08 2004 from a physician, it was reported that the original reporting physician had retired from the facility shortly after reporting this case in 2000. The physician who replaced the reporter at the facility checked his database in an attempt to locate more information for this case, but was unable to locate any information for this patient, who remains unidentified. NO further information is anticipated, this case is considered closed. From follow up information received on Sept 26 2005. Case received from a VAERS extraction for the period from 1991 to 2005, and linked to nine other cases. Based on medical information this case had been upgraded to Serious. It was reported that the patient was 19 year old male and received vaccination on may 19 2000. the patient developed fever, chills and a cough on Jun 04 2000. On Jun 12 2000, 24 days post immunization he developed lower extremity weakness. On Jun 14 2000 the patient was admitted to the hospital and was treated with IV immunoglobulins. The patient reportedly was diagnosed with Guillain Barre syndrome. No further information expected. The VAERS number 155420 was provided for this case. Other nine cases are U200000490, 200401816, 200501908, 200501909, 200501910, 200501911, 200501912, 200501913, 200501914.					Y				U	05/19/2000	06/12/2000	24		UNK	UNK	PPD				U200000491	1						2	Asthenia; Chills; Cough; Guillain-Barre syndrome; Pyrexia	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|MEN~SANOFI PASTEUR~UA170AA~UNK~~UN~MENINGOCOCCAL (MENOMUNE)~2|TD~AVENTIS PASTEUR~UNK~UNK~~UN~TETANUS DIPHTHERIA (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0245000	10/06/2005	GA	0.63	0	.6	M	10/03/2005	Rash all over body.				Y					Y	09/29/2005	10/03/2005	4		PVT	PUB						1						1	Rash	FLU3~SANOFI PASTEUR~U1765PA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245001	10/06/2005	NC	67.0	67		F	10/05/2005	During previous years flu shot caused headache, pain that subsided by next day. This year however had cold and hot flashes. Overall malaise getting worse to the point that couldn't get up, very weak, dizzy, have shortness of breath, felt pale, cold, clammy, little itchy, couldn't walk without help, dry mouth, sore throat, a bit nauseated. In ambulance, they found that the BP was up to 180 which is very unusual for her. Given fluids and Medication at ER. Released in morning, could move but a bit dizzy. 10/5 felt like run over by a truck, slight headache, weak, cold, pulse up to 95 which is higher than usual. Right now she feels a bit tired and with a headache, but feels much better.										10/03/2005	10/03/2005	0		OTH	PUB		NONE	Seasonal allergies			1						1	Asthenia; Chills; Cold sweat; Difficulty in walking; Dizziness; Dry mouth; Dyspnoea; Fatigue; Feeling cold; Gait disturbance; Headache; Hot flush; Hypertension; Hypokinesia; Malaise; Nausea; Pallor; Pharyngolaryngeal pain; Pruritus; Similar reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245051	10/06/2005	PA		5		M	10/06/2005	10/06/2005 3:50 placed call to pts # listed. Spoke to patients grandfather. Grandfather states he's fine, no problems. Younger voice on phone (child) stated he's ok, listening on other phone. Explained vaccine to grandfather. No adverse reaction.										09/30/2005				PVT	PVT	Proventil1 Intal	Asthmatic, recent fever	Asthma			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA132BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0245068	10/07/2005	AK	45.0	44		F	10/03/2005	Synchopal episode followed by perspiration, pallor and nausea. Ambulance called to home by husband follow up at Hospital ER.				Y					Y	09/20/2005	09/21/2005	1	Chest X ray, labs, EDG, WNL, Echocardiogram done, follow up to be done by cardiologist.	OTH	PUB	NONE	NONE	Penicillin			1						1	Hyperhidrosis; Nausea; Pallor; Syncope	FLU3~SANOFI PASTEUR~U1754AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245069	10/07/2005	SC	1.1	1	.1	M	10/05/2005	09/29/2005 temperature, rash 10/03/2005. 10/04/2005 seen in office T 105, rash worse, decrease in food intake, decrease urinary output- IV fluid.				Y						09/23/2005	09/30/2005	7	CBC	PVT	PVT						1						1	Decreased appetite; Oliguria; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U1753AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0151R~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0220R~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0245070	10/07/2005	NC	30.0	29		F	10/04/2005	About 10 mins after administration patient complained of feeling sweating, clammy and nausea. No visible hives. Per protocol diphenhydramine liquid was administer. Pt vomited and started to complain of difficulty breathing. 911 was called when pt vomited. Pt laid on floor and an epi pen was administered upon protocol. EMS arrived within 5 mins and took pt to hospital. Physician was contacted per protocol.				Y						10/04/2005	10/04/2005	0		OTH	PVT			Allergies, Keflex, Erythromycin, Latex, reported by pt after administration.			1						1	Cold sweat; Dyspnoea; Hyperhidrosis; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U1778AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245071	10/07/2005	IL	77.0	76		M	10/03/2005	Swelling and red rash at site of injection of Pneumovax vaccination.				Y					Y	09/30/2005	10/01/2005	1	NONE	OTH	PUB		NONE	NONE			1						1	Injection site hypersensitivity; Injection site oedema; Injection site rash; Injection site reaction	FLU3~SANOFI PASTEUR~U1806AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0692P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245104	10/07/2005	GA	35.0			M	10/07/2005	Pt admitted to Hospital with lower extremity weakness & subsequently diagnosed with Guillain Barre Syndrome. Infectious Diseases & Neurology consult teams could not find causative medication or infection other than influenza vaccine administered 2 to 3 weeks prior to admission. Information from discharge summary states apnea, convulsions, pneumonia, neuropathy.			Y		Y	85		Y	N		12/31/2004		Information from Discharge summary states herpes simplex, HIV syndrome and tuburcular aggrivation. Medical records state eeg abnormal. msv	UNK	UNK						1						1	Apnoea; Asthenia; Convulsion; Electroencephalogram abnormal; Guillain-Barre syndrome; HIV infection; Herpes simplex; Neuropathy; Pneumonia; Tuberculosis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0245106	10/07/2005	LA	6.0	5		F	10/07/2005	Two days after inhalation of FluMist, perioral rash and nasal itching reported.  Treated with Benedryl and resolved.									Y	10/03/2005	10/05/2005	2	none	UNK	UNK	Multivitamins	none	Sulfa Allergy/causes similar symptoms			1						1	Pruritus; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500389P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0245107	10/07/2005	CA	46.0	45		M	10/07/2005	Severe URI Sx: nasal congestion, sore throat, persistent cough, rhinorrhea, headache, low grade fever, chills, myalgia, general malaise............6-7 out 11 clinic staff vaccinated also came down with varying degree of URI/flu-like Sx's.									Y	09/30/2005	10/01/2005	1	consistent with viral URI	UNK	UNK		None - healthy	None			1						1	Chills; Cough; Headache; Malaise; Myalgia; Nasal congestion; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea; Upper respiratory tract infection	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0245108	10/07/2005	MI	75.0	74		F	10/07/2005	Administered at 10 AM October 6, 2005. Chills with shakes started at 3 PM, lasted 2 hrs. followed by high fever 102.9. I felt I was burning up. 911 call at 6 pm and was taken to hospital. Fever lasted all evening.  Was put on IV and antibiotic. Discharged 11:30 AM next day. October 7, 2005.				Y	Y	1			Y	10/06/2005	10/06/2005	0	Don't know	UNK	UNK						1						1	Chills; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~U1793AA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0245123	10/07/2005	MI	0.5	0	.5	M	10/07/2005	Fever of 102 developed within 4-6 hours of vaccine administration. Increased to max 104.7 taken in ear from 48-72 hours post vaccine.				Y					Y	10/04/2005	10/04/2005	0	Urinalysis via catheter, Positive blood, trace protein, blood and urine culture, CBC, results pending.	PVT	PVT	NONE	NONE	Newborn jaundice, umbilical granuloma,			1						1	Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A013AA~4~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~1762AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A56077A~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0245127	10/10/2005	NY				U		Bleeding at site, swollen area, fever HA										10/07/2005	10/10/2005	3		UNK	UNK	Premarin, Zomar, Lexopvil					1						1	Injection site haemorrhage; Injection site oedema; Pyrexia	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0245129	10/10/2005	GA	59.0	58		F	10/10/2005	started with swelling and pain at the site, then progressed to swelling of entire upper arm down to the elbow. Redness and fever (hot to the touch) of the entire upper arm down to the elbow with increased pain of the entire upper arm down to the elbow. Doctor on call (it was Sunday) prescribed benadryl and lortab for pain, plus putting ice on upper arm for fifteen minutes four times a day.				Y					U	10/08/2005	10/08/2005	0		UNK	UNK	Diltiazem Diovan	None	Allergic to Penicillin & Sulfa  High Blood Pressure			1						1	Erythema; Injection site pain; Injection site swelling; Oedema peripheral; Pyrexia	FLU3~SANOFI PASTEUR~U1771AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0740H~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245131	10/10/2005	AK	36.0	35		F	10/10/2005	Describe the suspected adverse event. Such things as temperature, local and general signs and symptoms, time course, durations of symptoms diagnosis, treatment and recovery should be noted.  Approx 5 hours after administration the patient starting itching and then 2 hours later started breaking out in a rash & wheals. Rash/wheals are on her forearms, across top of chest, on her breast and abdomen. Few lesions on her back. Benadryl 25 mg eliminates itching for approx 4-6 hrs. She is not sure if the rash fades during that time.  No generalized sxs such as wheezing, dyspnea, dysphagia, tachycardia.  Has taken the Flu Shot annually without prior difficulty.									U	10/07/2005	10/07/2005	0	No diagnostic/lab tests available.	UNK	UNK	Vitamin C Centrum Multiple Vitamins	None	Had a miscarriage in August which required a D&C.			1						1	Pyrexia; Rash; Skin ulcer; Urticaria	FLU3~SANOFI PASTEUR~U1754AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245142	10/10/2005		65.0			F		A literature report was received on 27Sep05 concerning a 65 year old Caucasian female. No details were provided regarding the vaccinee's medical history or concomitant medications. Within a few days of vaccination with an influenza vaccine (brand unspecified) in her right arm, the vaccinee developed pruritic nodule at the injection site, which grew to 2cm in diameter. Despite being prescribed with antibiotics and a warm compress, the lesion continued to increase in size. A biopsy, performed six weeks after the initial presentation, revealed a granulomatous and mixed cellular infiltration that was interpreted as reactive in nature. No pathological micro organisms were identified histologically or in cultures obtained from lesional tissue. Within a month after the initial biopsy, the nodule had enlarged to 5cm and had begun to ulcerate. The lesion was resected and revealed a similar reactive histology compared to the initial biopsy. Over the next two years, the lesion continued to increased in size and ulcerate, despite numerous attempts at resection and various courses of oral and topical corticosteroid therapy. Cultures for infectious microorganisms were consistently negative. A course of low dose radiotherapy was administered three years after initial presentation and resulted in complete regression of the lesion and healing of the overlying epidermis. The vaccinee has not had a recurrence within a nine year follow up period, after radiation treatment. Analysis of the tissue samples showed that they all had similar histopathological finding. The epidermis was ulcerated and the full thickness of the reticular dermis was effaced by a sheet of cells extending into subcutaneous fate. The inflammatory proliferation was comprised of a cellular, atypical but polymorphic lymphohistiocytic population of mononuclear cells. The proliferation was characterized by mostly small to medium seized lymphocytes, some with a Plasmacytoid appearance, on a histolytic background. Larger immunoblastic cells made up a small component of the infiltration. In addition, there were scattered areas of necrotizing granulomatous inflammation within the cellular dermal infiltration. The majority of the small lymphoid cells were positive for CD3 and CD5 pan T cell markers. Some small lymphocytes stained with the pan B-cell marker CD20. The larger lymphoid cells predominately marked with CD20. Lymphoid follicle formation was evident in the initial resection but was not present in subsequent material. Special stains for acid fast bacterial and fungal organisms were consistently negative. In situ hybridization studies for kappa and lambda immunoglobulin light chains revealed polytypic plasma cell populations with kappa or lambda ratios of approximately three to one. PCR studies revealed neither clonal immunoglobulin heavy chain nor T-cell receptor gene rearrangement. The authors suggest that although the large majority of pt's received vaccinations do not developed atypical lymphoid proliferations in the vaccination site, the antigenic stimulus of the influenza virus components and/or vaccination associated adjuvants and carriers more than likely triggered an aberrant inflammatory response in this pt. No further information is expected.													Biopsy	UNK	UNK	NONE				CVOX200500128	1						1	Granuloma; Injection site nodule; Injection site oedema; Lymphocyte morphology abnormal; Skin ulcer	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0245144	10/10/2005	SC	22.0	22		F		Tender, red, swollen, size of quarter 1st day, 2nd day size of a coffee cup, 3rd day less redness size increase of an inch but not as much as the 1st and 2nd day.									Y	10/03/2005	10/04/2005	1		OTH	OTH			Asthma, surgical tape, NKDA			1						1	Hypersensitivity; Oedema; Tenderness	FLU3~SANOFI PASTEUR~U1753AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TTOX~SANOFI PASTEUR~U1584BA~UNK~~RA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0245145	10/10/2005	NC	12.0	12		M	10/06/2005	Tender, Red, Swollen for 2 days.										10/03/2005	10/04/2005	1		PVT	UNK	Concerta 54 mg tabs		NKDA			1						1	Hypersensitivity; Oedema; Tenderness	FLU3~SANOFI PASTEUR~U1753AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~AVENTIS PASTEUR~U1584BA~UNK~~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0245146	10/10/2005	NY		91		F	10/07/2005	Local redness, malaise 4 x 6cm.				Y					Y	10/06/2005	10/07/2005	1		PVT	PUB			Sulfa			1						1	Injection site hypersensitivity; Malaise	FLU3~SANOFI PASTEUR~U1846AA~5~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245147	10/10/2005	TX	28.0	27		M	10/06/2005	Local swelling, pain, within 3hours nausea, diaphoresis, myalgia, malaise.									U	10/04/2005	10/04/2005	0	NONE	PVT	PVT		NONE	NONE			1						1	Hyperhidrosis; Injection site oedema; Injection site pain; Malaise; Myalgia; Nausea	FLU3~SANOFI PASTEUR~U1833BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245151	10/10/2005	TX	4.0	4		M	10/07/2005	8 x 9 area of erythema, induration at thigh at site of injection, nontender. Occurred 24 hours after Influenza vaccine (Fluzone) seen after 3 days.									Y	10/04/2005	10/05/2005	1		PVT	PVT	NONE	NONE	Hepatoblastoma, eczema			1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U1756AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245135	10/11/2005	CA	46.0	46		F	10/10/2005	Over 1 week of nasal congestion and rhinorrhea.  2-3 days of general malaise.  Headache 1 day. Above symptoms treated with over the counter cold remedies including Claritin, and Nyquil.									N	09/30/2005	10/02/2005	2		MIL	MIL	none	none	none			1						1	Headache; Malaise; Nasal congestion; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0245136	10/11/2005	OR	36.0	35		M	10/11/2005	High Fever Difficult Breathing Hoarseness Weakness Dizziness Soreness All Over The Body Stomach Ache Nausea				Y					N	10/10/2005	10/10/2005	0		UNK	UNK		none	novocaine			1						1	Abdominal pain upper; Asthenia; Dizziness; Dysphonia; Dyspnoea; Nausea; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0245169	10/11/2005	NC	58.0	58		M	10/05/2005	Left arm became warm, red and swollen Monday prn (10/3/05). Didn't check temp but had chills and sweats Monday pm, sluggish yesterday. Today (105.5) area 5x7 inner left arm with warmth and redness, lower left arm 1x3 area of redness only. Pt states feels better today.										10/03/2005	10/03/2005	0		PUB	PVT	Unsure of name of blood pressure meds.	NONE	Blood pressure, stents x 2 (x6 years), Polyp from 10 days removed 3 weeks later.		NC05086	1						1	Chills; Feeling hot; Hyperhidrosis; Injection site erythema; Injection site oedema; Sluggishness	FLU3~SANOFI PASTEUR~1819AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0691P~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245170	10/11/2005	CA	69.0	68		F	10/04/2005	Fever, chills (102.0 temp). Clear liquids, Tylenol 500mg-650mg every 6 hrs.									Y	09/27/2005	09/28/2005	1		PVT	UNK		NONE	NONE			1						1	Chills; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~142AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0578P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245171	10/11/2005	CA	75.0	74		F	10/04/2005	Fever and chills. Take Tylenol 600mg every 6 hrs. Warm compress if any swelling.									Y	09/29/2005	09/30/2005	1		PVT	UNK						1						1	Chills; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~142AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0578P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245172	10/11/2005	MI	54.0	53		F	10/04/2005	Hives									Y	10/04/2005	10/04/2005	0	NONE	PVT	UNK	NONE	NONE	Allergic to PPD			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1804AA~4~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245173	10/11/2005	NC	4.0	4		F	10/06/2005	Some redness developed 24 hrs after injection, then dramatically worsened. At time of exam (44 hrs after injections), erythema, induration 21x19cm L ant thigh with patch of vesicles medial to injection site. Fever 101 at most, locally 99-100.				Y					U	10/04/2005	10/05/2005	1		PVT	PVT						1						1	Injection site erythema; Injection site mass; Injection site vesicles; Pyrexia	DTAP~SANOFI PASTEUR~U1369DB~5~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1777AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0264~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0467P~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0245174	10/11/2005	IN	1.65	1	.6	M	10/04/2005	Pt started running a temp 10/1/05 am 104ax will on way to Dr's ofc, pt had seizure btwn 10am-11am was taken to ER for eval. Seen in our ofc 10/3/05 doing ok, no fever, no further seizure activity.				Y					Y	09/30/2005	10/01/2005	1	ER-CXR, U/A and Chem 7, CBC, bid Cx. No testing done by PCP.	PVT	PVT	NONE	NONE	NONE			1						1	Convulsion; Pyrexia	FLU3~SANOFI PASTEUR~U1806AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245175	10/11/2005	OH	46.0	46		F	09/30/2005	Cough, wheezing, shortness at breath, red/irritated eyes.									Y	09/29/2005	09/29/2005	0	NONE	OTH	PVT	Prevacid, Lexapro	NONE	NONE			1						1	Cough; Dyspnoea; Eye irritation; Ocular hyperaemia; Wheezing	FLU3~SANOFI PASTEUR~U1778AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245176	10/11/2005	CA	5.0			F	10/06/2005	Large area of erythema and edema at site of injection, developed within 1/2 hr of receiving injection. Subsequent development of diffuse maculopapular pruritic rash on trunk and extremities.									Y				RAST	PVT	UNK		NONE	Asthma			1						1	Injection site erythema; Injection site oedema; Rash maculo-papular; Rash pruritic	FLU3~SANOFI PASTEUR~U1745AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245195	10/11/2005	GA	10.0	9		F	10/11/2005	Received flu vaccine yesterday, 10/10/2005, patient presented to office today with urticaria on chest, back, upper and lower extremities. Child has no c/o sore throat, cough No fever. Physical exam wnl. TX: Benadryl qid for 2 days prn									Y	10/10/2005	10/10/2005	0		UNK	UNK	none	none	none			1						1	Urticaria	FLU3~SANOFI PASTEUR~u180400~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245205	10/11/2005	DC	40.0	40		F	10/11/2005	LOCAL SWELLING AT SITE AND TENDERNESS WITHIN 8 HOURS.  4-5 CM.									Y	10/10/2005	10/10/2005	0	NONE	UNK	UNK		NONE	NONE			1						1	Injection site swelling; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA144BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1|TTOX~SANOFI PASTEUR~U1586CA~UNK~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0245209	10/11/2005	MN	32.0	32		F	10/11/2005	Approximately a week to ten days following flu shot, I developed severe joint and muscle aches (all over the body), a 104 degree temperature, chills, stiff neck and headache.  This lasted for four days and was gone just as quickly as it started.  I assumed I had the flu!  Two weeks later, the same exact symptoms returned, and I've had them several times since then.  Went to see my doctor on the third bout, and had blood work done.  My white blood cell count was elevated to over 18,000.  He put me on antibiotics and when I didn't get better in two days I went back.  Still had a very stiff neck so he referred me to another physician.  I was hospitalized and checked for meningitis, Lyme's disease, STD's, Hep C, familial mediterranean fever, lupus, several other types of diseases.  (Had a positive ANA and elevated CRP).  I am now under the care of a rheumatologist and taking Plaquenil for Rheumatoid arthritis, although I don't think he's positive that's what I have, and I also take methylprednisolone when I have a flare.  My last flare was in September 2005 and lasted 3 days. Information from 60 day follow-up report states: Sporadic episodes of all over body aches, chills, above 100 degrees fever, neck pain, headaches, weakness. This lasts anywhere from 3-5 days. I really don't know if all of this is stemming from th flu shot, but it just seemed odd that after the one and only flu shot I ever had, I now get these recurring flu-like symptoms. 12/31/09 I am currently taking Plaquenil and havent had any flu-like episodes recently . The last on was in March '06-achy joints and muscles and a fever. So I am not sure if I am recovered or just waiting for the next episode.				Y	Y	3			U	12/13/2003	12/31/2003	18	Positive ANA Elevated CRP Elevated white blood cell count when having a flare	UNK	UNK	synthroid; Plaquenil	none	hypothyroidism			1						1	Antinuclear antibody positive; Arthralgia; Asthenia; C-reactive protein increased; Chills; Headache; Musculoskeletal stiffness; Myalgia; Neck pain; Pain; Pyrexia; Rheumatoid arthritis; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0245210	10/11/2005	TX	21.0	21		M	10/11/2005	Symptoms Weakness in the arms, and legs. Numbness all over body, left facial droop, blurry vision. It took all of three weeks to take over entire body.  Diagnoses Guillain-Barre Syndrome  Treatment Immunoglobin Gamma Globulin			Y	Y	Y	26	Y		U	01/23/2004	03/05/2004	42	Spinal tap Computerized axial tomography of head Magnetic Resonance imaging of brain and brain stem Magnetic resonance imaging of spinal canal	MIL	MIL	None	None	None			1						1	Facial palsy; Guillain-Barre syndrome; Hypoaesthesia; Muscular weakness; Vision blurred	FLUX~UNKNOWN MANUFACTURER~~1~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~1~ID~RA~MENINGOCOCCAL (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~1~ID~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0245213	10/11/2005	GA	81.0	81		F	10/11/2005	Pt experienced Nausea and vomiting 1 - 1 1/2 hours after getting flu vaccine. Advised pt to see DR but pt went home, husband called and said she was better, probably car sick plus empty stomach.									Y	10/11/2005	10/11/2005	0		OTH	PVT			Allx Codeine.			1						1	Nausea; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA142AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0245214	10/11/2005	VA	1.48	1	.5	F	10/11/2005	In 2 hrs pt developed swelling and purpura to upper parts of both legs and urticaria all over body pt was given Benadryl.				Y					Y	10/07/2005	10/08/2005	1	WBC 15.0	PVT	PUB	Motrin Suspension	NONE				1						1	Oedema; Purpura; Urticaria; White blood cell count increased	DTAPH~SANOFI PASTEUR~U1400AA~UNK~IM~~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~U1765EA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245215	10/11/2005	GA		77		F	10/11/2005	Pt refers started with knee pains on 10/03/2005, then body aches, fever, headache, decreased appetite, nausea with vomiting x 2 on 10/04/2005. Was seen by MD on 10/05/2005 V/S fer 112 BPM, BP 12/68, T 100.0, recommended bedrest, Tylenol G 4hr and increased fluids.									Y	09/26/2005	10/03/2005	7	CBC, Influence AB A 1.32, B 1.16	PVT	UNK		Hyperlipidemia, Hypothyroidism, allergic rhinitis.	PCN			1						1	Arthralgia; Decreased appetite; Headache; Nausea; Pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1777AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245216	10/11/2005	CA		77		F	10/11/2005	Itching started at night and got progressively worse to the point of hives. On 10/07 felt nauseated, dizzy, woke up with perspiration. 10/11 called doctor and waiting for prescriptions to arrive. Complains of hoarseness.									N	10/06/2005	10/09/2005	3		OTH	OTH	Fosamax, Hyson, aspirin, pepside, substitute, Celebrex, Zyrtec, Predosone, Norex, Nebulizer with albuterol when needed, Lescol.	Pequin Antibiotics	Arthritis, asthma, Blood pressure.			1						1	Dizziness; Dysphonia; Hyperhidrosis; Nausea; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0245238	10/12/2005	CT	1.28	1	.3	F	10/07/2005	Status epilepticus for 30 minutes. Ativan, Phenytine, intubated, 39C temperature. Continued seizures trilepta. Information from discharge summary states eye disorder, rash, somnolance, confusion, paralysis, apnea. msv Medical records states fever. msv				Y	Y		Y	Y	N	09/24/2005	10/02/2005	8	Discharge summary states EEG abnormal. msv	PVT	PUB		NONE	Febrile seizure (4/19/05)			1						1	Apnoea; Confusional state; Convulsion; Electroencephalogram abnormal; Eye disorder; Hypoxia; Paralysis; Pyrexia; Rash; Somnolence; Status epilepticus	FLU3~SANOFI PASTEUR~U1755AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE599AA~4~~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0237R~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A6718817~4~~LL~PNEUMO (PREVNAR)~1	USA	Hospitalisation,Disabling	Influenza
0245239	10/12/2005	CA	1.7	1	.7	F	10/04/2005	Pt had no adverse reactions with imms. Pt admitted to hosp on 9/30/05 for croup x 24 hrs.					Y	1			Y	09/29/2005	09/30/2005	1	Mycoplasma, RSV, Chems, UA, influenza A/B	PVT	PVT	NONE	NONE	NONE			1						1	Croup infectious; Laboratory test abnormal; Respiratory syncytial virus infection	DTAP~SANOFI PASTEUR~C2253AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1743LA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0245244	10/12/2005	PA	0.56	0	.6	M	10/04/2005	NONE Per annual report-.5ml given instead of 0.25ml									Y	09/29/2005	09/29/2005	0	NONE	PVT	PVT	NONE					1						1	Incorrect dose administered	DTAP~SANOFI PASTEUR~C2277AA~3~~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1833BA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A98341C~3~~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0245245	10/12/2005	OK	12.0	11		M	10/07/2005	Localized swelling and redness of injection site.									Y	10/06/2005	10/06/2005	0	NONE	PVT	PVT			Asthma, Cashew allergy			1						1	Injection site hypersensitivity; Injection site oedema	FLU3~SANOFI PASTEUR~U1806AA~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245246	10/12/2005	CA	5.0	4		M	10/06/2005	Swelling, Erythema right deltoid 7.5 x 10.5 cm.										10/04/2005	10/05/2005	1		PVT	UNK						1						1	Erythema; Oedema	DTAP~SANOFI PASTEUR~C2243AA~5~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1818AB~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0343~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0578R~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0245247	10/12/2005	FL	0.51	0	.5	M	10/04/2005	Diffuse Urticaria noted by mom approx. 1 1/2 hrs after vaccine administration. PE in office, Urticaria trunk, extremities and sl or face. No respiratory changes. No wheezing, stridor.				Y					Y	10/04/2005	10/04/2005	0		PVT	PVT	NONE	NONE	NONE			1						1	Urticaria	DTAP~SANOFI PASTEUR~C2243AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1743HA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE336AA~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A56117B~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0245248	10/12/2005	PA	68.0	68		F	10/07/2005	Red, tender at injection site. No signs of infection.									Y	10/05/2005	10/05/2005	0		PVT	PVT						1						1	Injection site erythema; Tenderness	FLU3~SANOFI PASTEUR~U1777AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0790P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245249	10/12/2005	IL	0.74	0	.7	F	10/04/2005	Eyelid swelling, wheezing, hives 10/17/05 Review of medical records indicates chief complaint of swelling around eyes ? allergic reaction to flu vaccine. Final diagnosis was stated as Acute Allergic Reaction (not otherwise specified). Additional symptom noted was trouble breathing.				Y					Y	09/29/2005	09/29/2005	0		PVT	PVT		Mild congestion				1						1	Dyspnoea; Eyelid oedema; Hypersensitivity; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U1765BA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245250	10/12/2005	GA	35.0	34		F	10/05/2005	Pt c/o soreness and swelling in left arm from elbow to shoulder 4 hrs after vaccination. She went to Dr the next day and received treatment.				Y					U	10/04/2005	10/04/2005	0		OTH	PVT		Depressed immune system				1						1	Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U1747AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749P~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245252	10/12/2005	OH	77.0	76		M	10/12/2005	Rapid heartbeat (92-regular 54), sweating, dizzy, took 6 Nitroglycerin sl tabs to treat.									Y	09/30/2005	10/01/2005	1		OTH	PVT			Heart disease			1						1	Dizziness; Heart rate increased; Hyperhidrosis	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245255	10/12/2005	MN	44.0	43		F	10/12/2005	I received the injection on 10/7/05.  Approximately 3-5 minutes after receiving the vaccine I had a local reaction as e/b itching & redness at the site.  Approximately 10 minutes after receiving the vaccine I became short of breath & started to wheeze & cough.  I then went to the ER & received treatment. I had solumedrol IV, Benadryl 50 mg IV, Prednisone 30mg orally and  neb treatment. I was also started on a Solumedrol pack which I started on 10/8/05.				Y					Y	10/07/2005	10/07/2005	0		UNK	UNK	Atenolol 25 mg daily HCTZ 25 mg daily Effexor 150mg daily Premarin 1.25mg daily	None	Allergic to corn, wheat, weeds, tree mix, ragweeds, perfumes, smoke.  Asthma			1						1	Cough; Dyspnoea; Injection site erythema; Injection site hypersensitivity; Pruritus; Wheezing	FLU3~SANOFI PASTEUR~U1805AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245256	10/12/2005	CA	26.0	26		F	10/12/2005	Approx. two days after taking FluMist, I got sore throat, runny and stuffed nose, swollen and runny eyes, non productive cough, general aches and pains and headache.									Y	09/30/2005	10/02/2005	2		MIL	MIL	Prenatal Vitamins, Claritin, Aciphex	none	Seasonal Allergies, GERD			1						1	Cough; Eye swelling; Headache; Lacrimation increased; Nasal congestion; Pain; Pharyngolaryngeal pain; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500390P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0245257	10/12/2005	KS	46.0	45		M	10/12/2005	Headache, watery eyes, blurry vision, post-nasal drip, runny nose, sore throat, muscle and joint aches, low-grade fever (100),diarrhea. All symptoms occurred within 4 hrs of Flu-Mist. treated with Motrin 800 mg /6 hrs and Dayquil.									Y	10/11/2005	10/11/2005	0		MIL	MIL		None	NKDA	Same as above (lesser degree)~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Arthralgia; Diarrhoea; Headache; Lacrimation increased; Myalgia; Pharyngolaryngeal pain; Postnasal drip; Pyrexia; Rhinorrhoea; Vision blurred	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0245260	10/12/2005	CA	52.0	51		F	10/12/2005	Patient began with itching and hives 24 hours after getting vaccine.  Also reports new blanket on bed.  Taking over the counter Benadryl and Alavert.  States not severe enough to be seen by PCP.									U	10/10/2005	10/11/2005	1		UNK	UNK	Atenolol Paxil Albuterol glucosamine/chondratin	None	Atrial flutter/fib; Depression; Asthma Allergy to dust			1						1	Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA120BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0245261	10/12/2005	NY	84.0	84		M	10/12/2005	Night after I got shot. Woke up around 2 am. Threw up and sick to my stomach. Was dizzy which lasted for about six weeks. Don't know if I had a adverse effect. But now afraid to get flu shot this year.				Y					Y	10/18/2004	10/19/2004	1		MIL	OTH		none	none			1						1	Dizziness; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U1447AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245262	10/12/2005	HI	4.0	4		M	10/12/2005	Myalgia, Fever up to 101, Chills.  Treat with Tylenol or Motrin, Bath/Ice Packs, Pushe fluids.				Y					N	10/11/2005	10/11/2005	0	None	UNK	UNK	None	None	None			1						1	Chills; Myalgia; Pyrexia	DTAP~GLAXOSMITHKLINE BIOLOGICALS~628C9~5~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1754AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0265~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0485R~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0245267	10/12/2005	CA	11.0	11		M		Flu vaccine administered at 11AM, 8 hrs later had seizure asthma episode 911 was called, dx'd at ER, sent home same day.				Y					Y	10/08/2005	10/08/2005	0		PVT	PVT	Singulair	NONE	IgA deficiency, asthma, allergic rhinitis, viteligo			1						1	Asthma; Convulsion	FLU3~SANOFI PASTEUR~U1803AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245318	10/13/2005	MS	59.0	58		U	10/13/2005	Given Hep A vaccine instead of Flu Vaccine in right deltoid. Last Hep A app 3 weeks ago. Explained to Pt, given the vaccine right deltoid.									Y	10/13/2005				UNK	UNK	NONE	NONE	NONE			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA145BA~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~0546R~2~IM~RA~HEP A (HAVRIX)~1	USA		Influenza
0245341	10/13/2005	MI	73.0	73		F	10/06/2005	Redness around arm near injection site, with feeling of warmth. Dr treated pt with antibiotics and redness has subsided as of 10/06/2005.				Y					Y	10/02/2005	10/03/2005	1		OTH	OTH	UNK	NONE	UNK			1						1	Feeling hot; Injection site hypersensitivity	FLU3~SANOFI PASTEUR~U1746AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245342	10/13/2005	CA	51.0	50		F	10/07/2005	Arm swelling, itching, redness with axillary tenderness with flu vaccine.				Y					Y	10/04/2005	10/05/2005	1		PUB	PVT	Ketoprofen, Vicodin, Premarin, Zoloft.	COPD. rheumatoid arthritis	Nicotine dependence, allergic rhinitis, anxiety			1						1	Injection site hypersensitivity; Injection site oedema; Pruritus; Tenderness	FLU3~SANOFI PASTEUR~U1818AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0490P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245343	10/13/2005	AZ	2.0	2	.1	F	10/10/2005	Large local swelling, redness and warmth around site from left shoulder point to just above elbow. DX large local reaction to vaccine DTap prob. Tx Benadryl 2 tsp TID x 2D.									Y	10/06/2005	10/07/2005	1		PVT	PUB	NONE	Well check	Congenital Ptosis			1						1	Feeling hot; Injection site hypersensitivity; Injection site oedema	DTAP~SANOFI PASTEUR~C2222AA~4~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1765EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0400R~1~IM~RA~HEP A (VAQTA)~1	USA		Influenza
0245357	10/13/2005	OH	23.0	23		F	10/06/2005	C/O heavy chest, unable to take deep breath. Feels like cold air with deep breathing.  Throat feels tight.				Y					Y	10/06/2005	10/06/2005	0	Sent to ED recieved breathing treatment, 8mg Decadron IV sent home on Medrol Pack	UNK	UNK	Othotricycleine (BCP)	none	none		KY200526	1						1	Chest pain; Dyspnoea; Throat tightness	FLU3~SANOFI PASTEUR~U1794AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245358	10/13/2005	MD	34.0	34		F	10/13/2005	Swelling of throat within 12 hours of the vaccine.									Y	10/12/2005	10/12/2005	0		UNK	UNK						1						1	Pharyngeal oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0245359	10/13/2005	TN	74.0	73		F	10/13/2005	Arm became sore right after shot. As evening progressed, arm started hurting down to finger tips, then up to shoulder, into back of neck. Started running fever 101, started chilling, severe headache, laid down at this time, throat started feeling like it was closing up.  Called my son in medical. He said if this continued to go to EM. I took 2 Tylenol, covered up, because of chilling. Went to sleep.  Woke up sweating. Fever gone. Next morning upon arising my ears were ringing, sound was like in a cave. I figured it was all from the shot. I got o.k. by that evening, everything o.k. Not. Took the shot last year, no problem at all.									Y	09/30/2005	09/30/2005	0		UNK	UNK	Prilosec; Atenolol; Allegra D.	none	Allergies to mold, grass.			1						1	Chills; Headache; Hyperhidrosis; Pain; Pyrexia; Throat tightness; Tinnitus	FLU3~SANOFI PASTEUR~49281037615~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245361	10/13/2005	MN	82.0	81		F	10/13/2005	Pt states had 1 X 1 local, reddened and warm to touch area a few hours post revaccination of the Pneumovax. Today, arm is not sore, but continues with the red local reaction. Pt advised to call back if area.									U	01/10/2005	01/10/2005	0		UNK	UNK						1						1	Injection site erythema; Injection site reaction; Injection site warmth	FLU3~SANOFI PASTEUR~U1839AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245365	10/13/2005	NY	59.0	58		F	10/13/2005	Approximately 45 minutes after receiving the Sanofi Pasture Fluzone Lot # u1839AA.  Prior to arrival back at the clinic, She felt a tightness in the chest and throat that reminded her of asthma like symptoms.  Client had a history of Asthma, and used her Inhailer (Albuterol) 2 puffs, with some relief.  Client reported the above, was seated in the clinic BP 150/80 p 100, Respirations 22 regular but slightly labored. Client was observed for 20 minutes and s/sx did not worsen she was allowed to leave with instructions to return if s/sx worsened, or to go to DR or Hospital.									Y	10/13/2005	10/13/2005	0		UNK	UNK	Albuterol, Claritan	none	Asthma			1						1	Chest discomfort; Dyspnoea; Throat tightness	FLU3~SANOFI PASTEUR~u1839aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245366	10/13/2005	CO	33.0	33		F	10/13/2005	The patient had her flu shot on 10/12/05. Patient called reporting fixed drug eruptions on face, back and chest.  She says they look like pimples.									U	10/08/2005	10/09/2005	1		UNK	UNK	Fexofenadine Tab 180 mg Levothyroxine Tab 75 mcg Atacand 32 mg Synthroid Tab 0.075 mg Allegra Tab 180 mg Cellcept 250 mg cap		Kidney problems			1						1	Acne	FLU3~SANOFI PASTEUR~U1805AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245367	10/13/2005	IL	29.0	28		F	10/13/2005	9 cm. area of redness, induration, painful and warm to touch.									Y	10/12/2005	10/13/2005	1	None	UNK	UNK	None	None	None			1						1	Injection site erythema; Injection site induration; Injection site warmth; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA131AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0245368	10/13/2005	NY	51.0	51		F	10/13/2005	Client came back to flu clinic at approx. 12:30pm complaining of not feeling right.  Received her flu vaccination at approx.10:30am.  Stated she began with asthma symptoms within 1 hour of receiving her flu vaccination.  Describes symptoms of tightness in chest, with some difficulty breathing.  She administered 2 puffs of her Albuterol Inhaler with minimal relief at approx. 11:30am.  She also complained of tingling in her L arm at the site of flu injection.  Minimal reddness/swelling noted.  BP at 12:30pm was 130/82  HR-76 reg and Respir.20 easy and non-labored.  Dr was notified at this time.  Information re: clients medical history/medications and visit assessment given to Dr.  Dr. felt this not to be an acute event and no further tx was warrented at this time. He did ask that client be informed to see her Primary Care Physician if symptoms became more severe and writer did inform client of Dr's recommendations.  Writer did call client back at 3:00pm for  follow-up and client stated her symptoms had improved.									Y	10/13/2005	10/13/2005	0	BP at 12:30pm-130/82  HR-76  Respir-20	UNK	UNK	Albuterol 2 puffs prn Asthma Allegra D qd Synthroid 150 mcg qd Estradial 1mg po qd	none	Hypothyroidism Asthma			1						1	Asthma; Chest discomfort; Dyspnoea; Feeling abnormal; Injection site erythema; Injection site swelling; Paraesthesia	FLU3~SANOFI PASTEUR~U1839AA~UNK~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245370	10/13/2005	MN	68.0	67		F	10/13/2005	Lips swelled.  Difficulty swallowing.  Inside of mouth burned.  Gums were red.  Took Benadryl and symptoms subsided.				Y					Y	10/12/2005	10/12/2005	0	Unknown.  Did see doctor the following day.	UNK	UNK	Vitamin C daily Multivitamin and calcium daily Advil prn for pain	none	none			1						1	Dysphagia; Face oedema; Gingivitis	FLU3~SANOFI PASTEUR~U1744AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245371	10/13/2005	NY	51.0	50		F	10/13/2005	Information described was reported to writer by RN.  She reports that client came to see her on October 11, 2005 at approx. 4:20pm. Client reported that she had received that influenza vaccine earlier in the day at approx. 10am.  Client reported that she experienced onset of symptoms at approx. 1pm consisting of tightness and heaviness in her chest, hoarness of voice with wheezing and coughing.  Client did reportedly stated she took 50 mg of Benedryl by mouth at 2pm with some relief of symptoms.  Client's medical hx is significant for Asthmatic Bronchitis and Cold Induced Asthma.  Client was assessed and a referral to the ED was made.				Y					U	10/11/2005	10/11/2005	0		UNK	UNK	unknown	unknown	Asthmatic Bronchitis Cold Induced Asthma Allergies: PCN			1						1	Chest discomfort; Chest pain; Cough; Dysphonia; Wheezing	FLU3~SANOFI PASTEUR~U1839AA~UNK~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245373	10/13/2005	PA	60.0	60		F	10/13/2005	Redness, swelling, heat, pain, hardness of large area between left elbow and shoulder around site of pneumonia injection. (No adverse reaction from flu shot in right arm.)  First night- bands of black and red around swollen area.  Second night - black and red bands were gone, but all other symptoms remained.  Third night - swelling somewhat diminished, redness & hardness significantly diminished, radiating heat is gone, tenderness has replaced pain in arm.									Y	10/11/2005	10/11/2005	0	I didn't see a doctor or get tested.  I expect the swelling, redness, and soreness to continue to decline, but am reporting this since I have seen no signs of these symptoms listed anywhere, and other people should know that this can develop. I checked the internet & saw only that breathing difficulties & hives are serious adverse reactions to the shot, & since I didn't have these symptoms I believed that my reactions were not reason enough to see a doctor. What I experience(d)has not been a mild reaction, but has been a significant and painful reaction to the pneumonia vaccine.	UNK	UNK	singulair, allegra 180, actonel	none	asthma, outdoor and indoor environmental allergies, osteoporosis			1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245377	10/13/2005	PA		14		M	10/10/2005	Fever day of vaccine; no fever in office at time of vaccination. Child appeared to be fine for next 3 days. About 3 days after 10/8, awoke with T 105, facial rash and left arm/shoulder pain. Seen in office 10/9 AM; lab evaluation. Transported to hospital. Care at ER and PICU.			Y	Y	Y	1			N	10/04/2005	10/09/2005	5	CRP 27.5; Blood culture - Group A Strep	PVT	PVT		Low grade febrile illness	Amoxil, bacone, cefal, hives, Ebstein Anomaly			1						1	Bacterial infection; Pyrexia; Rash; Shoulder pain	FLU3~SANOFI PASTEUR~U1804AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0245379	10/13/2005	UT	66.0	66		F	10/13/2005	Pt received both Pneumovax 23 and Fluzone per pt request on 10/11/05 in the right deltoid. On 10/12/05 her arm began swelling and started turning red. She had no fever except locally in the arm and felt mild flu-like symptoms.				Y					U	10/11/2005	10/12/2005	1	UNK	OTH	PVT	Clomdine, Toprol, Diovan, Lasix, Premarin	NONE	UNK			1						1	Feeling hot; Influenza like illness; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1805AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245380	10/13/2005	UT	56.0	55		F	10/11/2005	Pt received both Pneumovax 23 and Fluzone 2005 in left deltoid on her request  on 10/7/05. Over the weekend she experienced cold-like symptoms and redness that spread throughout the backside of her left arm. Pt saw family physician.				Y					Y	10/07/2005	10/08/2005	1	UNK	OTH	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Pharyngitis; Rhinitis	FLU3~SANOFI PASTEUR~U1805AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245381	10/13/2005	CA	81.0	81		F	10/13/2005	Redness at injection site. Rash about the face with swelling when Pt returned the following day. Gave pt some Benadryl and advised her to contact her physician.				Y					U	10/10/2005	10/11/2005	1		OTH	OTH		NONE	NONE			1						1	Face oedema; Injection site erythema; Rash	FLU3~SANOFI PASTEUR~U1818AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245382	10/14/2005	MN	68.0	68		F	10/13/2005	Patchy localized erythema and tenderness at injection site. Total size 12x15cm.				Y					U	10/11/2005	10/11/2005	0		PVT	PVT		NONE				1						1	Injection site erythema; Tenderness	FLU3~SANOFI PASTEUR~U1811AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0245383	10/14/2005	MN	68.0	68		M	10/13/2005	Erythema, swelling and tenderness at injection site extending distally to forearm (left) extent 25cmx12cm.				Y					Y	10/11/2005	10/11/2005	0		PVT	PVT		NONE				1						1	Injection site erythema; Injection site oedema; Tenderness	FLU3~SANOFI PASTEUR~U1811AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0245384	10/14/2005	MN	53.0	52		F	10/13/2005	Inflamed, Edematous upper arm									Y	10/03/2005	10/03/2005	0		PVT	PVT	Premarin, Zyrtec, Lipitor, Zetta	NONE	NONE			1						1	Injection site inflammation; Injection site oedema	FLU3~SANOFI PASTEUR~U1811AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245388	10/14/2005	TX	73.0	72		F	10/03/2005	Swelling, noted, redness, edema, warmth to touch, joints aching, Teeth aching.				Y					Y	09/28/2005	10/01/2005	3		OTH	PVT						1						1	Arthralgia; Feeling hot; Hypersensitivity; Oedema; Toothache	FLU3~SANOFI PASTEUR~U1811AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~AVENTIS PASTEUR~U1220BA~1~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1|YF~SANOFI PASTEUR~UE639AA~1~SC~RA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0245396	10/14/2005	PA	36.0			F	10/13/2005	A 36 yr old female pt with a medical history of no known allergies, although a seasonal intake of Allegra was reported, no medical conditions and no illness at the time of the vaccination experienced warmth and parasthesia in her right side of the hip, back and stomach i.e. approximately 30 minutes following the IM, deltoid administration of the influenza vaccine (Fluzone) on an unspecified date.  The pt visited a doctor following the event. It was reported that the vaccine administered approx three weeks ago from the time of the report. The pt was going for an MRI and she had not recovered at the time of the report.				Y					N					UNK	UNK	Allegra				200502026	1						1	Feeling hot; Paraesthesia	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245397	10/14/2005	TX	58.0	58		F	10/06/2005	Upper arm shoulder and eventually neck ached continuous for 1 year like when you get the flu shot. Then the spasms that lasted until 2004, Then weakness in the biceps and shoulder and neck. Now I have cramps in them so bad I have to straighten it out which hurt tremendously.								Y	Y	10/02/2002	10/02/2002	0	NONE	PUB	UNK		NONE	Asthma, COPD, Cancer-lung, osteoporosis.			1						1	Asthenia; Muscle spasms; Pain	FLU3~SANOFI PASTEUR~U0925AA~6~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0245399	10/14/2005	NY	5.0	5		M	10/08/2005	R deltoid area is slightly swollen with mod. erythema 6cm x 6cm patch, mildly tender, warmth, full ROM of right UE. Mom states increased redness over 2 days. Advised pt to use Motrin and ice PRN.									Y	10/06/2005	10/08/2005	2		PVT	PVT	Albuterol		Asthma			1						1	Erythema; Feeling hot; Hypersensitivity; Oedema; Tenderness	FLU3~SANOFI PASTEUR~U1746AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245400	10/14/2005	OH	1.0	1	.0	M	10/07/2005	Red, warm papules at injection site 1 firm lump subcutaneous.				Y					Y	09/27/2005	10/07/2005	10		PVT	PVT		Cough about 1 week.				1						1	Feeling hot; Injection site hypersensitivity; Injection site induration; Rash papular	DTAP~SANOFI PASTEUR~C2222AX~4~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1743HA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0116R~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0245401	10/14/2005	GA	73.0	73		M	10/12/2005	Pt had Pneumovax in right arm 10/10/2005 developed redness and pain right upper arm 10/11/2005.										10/10/2005	10/11/2005	1		PVT	PVT	Lisinopril, Glucophage, verapamil, ASA, Atenolol, HCTZ, Lipitor.	NONE	Septra allergy			1						1	Hypersensitivity; Pain	FLU3~SANOFI PASTEUR~U1794AA~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749P~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245402	10/14/2005	NJ	16.0	15		F	09/06/2005	A consumer reported that her 16 year old daughter received FluMist on 14 Dec 04 from her school clinic. Over the next 24 to 48 hours, the patient developed head cold, nasal congestion and tiredness. A couple of weeks later the patient still did not feel better. She was seen by her pediatrician, who on physical exam, said that the patient's nasal turbinate were swollen and clinically diagnosed her with sinus infection and prescribed oral Keflex (cephalexin) for 14 days. The symptoms, however continue. The pediatrician then prescribed Zyrtec (cetirizine hcl), Claritin (loratadine) and a saline nasal spray. In June 2005. she was referred to an allergist due to persistence of above symptoms. The patient underwent 60 different allergy testing which revealed that she was slightly allergic to pollen possibly from maple tree and ragweed. He prescribed oral Medrol. However, the allergist stated to the reporter that it was so mild that it should not produce the severity of the patient's symptoms. On 05 Jul 05, a CT scan of both sinuses showed sinus infection, swollen nasal turbinate and nasal septum deviation. The allergist prescribed Augmentin (co-amoxiclav) 1000 mg twice a day for 14 days and a nasal cortisone spray, which did not improve the patient's symptoms. In August 2005, the patient was referred to an ENT, who did a rhinoscope, which showed mild nasal septum deviation, sinus infection and excessive mucus production. The ENT physician suggested that a surgery to correct the nasal septum deviation should be done, but the reporter state she did not want the surgery done until the cause of the patient's chronic symptoms is known for sure. The reporter plans to bring patient back to the allergist and ask if a culture and sensitivity should be done. As of 06 Sep 05, the patient has not recovered from her symptoms, which now includes difficulty breathing due to the nasal congestion and pallor. The reporter state that the symptoms are possible related to FluMist.										12/14/2004	12/15/2004	1	Allergy test -NI- Positive; CT scan of both sinuses 07/05/05 Positive for sinus infection	OTH	OTH	Concomitant Drugs Not Reported		Eczema		MEDI0003667	1						1	Dyspnoea; Fatigue; Head discomfort; Mucosal inflammation; Nasal congestion; Pallor; Sinusitis; Swelling	FLUN3~MEDIMMUNE VACCINES, INC.~500357P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0245403	10/14/2005	SC	43.0			F	09/19/2005	A non health professional from physician's office reported that a 43 year old female received an expired FluMist vaccine on 24 Aug 05. The nurse who administered the vaccine later found out that the FluMist vaccine's expiration date on the label was 11 May 05. The patient did not report any adverse event following receipt of the vaccine. The reporter causality is not provided.									Y	08/24/2005	08/24/2005	0		PVT	OTH	Concomitant Drugs Not Reported		NONE		MEDI0003684	1						1	Unevaluable event	FLUN3~MEDIMMUNE VACCINES, INC.~500335P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0245404	10/14/2005	MN	67.0	67		F	10/11/2005	Patient experienced large hive like reaction below the site of injection. The hive was about 8 inches long and covered the width of her biceps. She has had the Pneumovax before with out incident. Rt arm became too sore to sleep on. Following morning arm was swollen, Red, sore, became worse by the next day and was moving to the elbow also, went 25 mi to closest Emergency room - saw by doctor who prescribed CEPHALEXIN 500 mg for 10 days.				Y					Y	09/28/2005	09/29/2005	1	None ordered	OTH	OTH	Albuterol; Hydrochlorothiazide; LIPITOR; PRILOSEC; PULMICORT; SYNTHROID; TRUSOPT	None	HTN, Smoker, Lymphoma., Asthma, Ba Barretts esophagus			1						1	Arthralgia; Erythema; No reaction on previous exposure to drug; Oedema peripheral; Pain in extremity; Urticaria	FLUX~UNKNOWN MANUFACTURER~~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0674E~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245430	10/14/2005	WI	6.0	6		F	10/14/2005	R ARM-RED, SWOLLEN, WARM, TENDER, UNABLE TO MOVE ARM, TEMP 103.									Y	10/12/2005	10/13/2005	1		UNK	UNK	ADVAIR 100/50	SORE THROAT	QUESTIONABLE ASTHMA			1						1	Hypokinesia; Injection site warmth; Pain; Pyrexia; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U1792AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0704P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245433	10/14/2005	AK	51.0	51		F	10/14/2005	pt received pneumovax in am. returned to clinic in pm c/o L upper arm pain with decreased mobility.L upper arm (deltoid area) warm to touch with minor swelling. no erythema. pt denied numbness, tingling, weakness L hand. unable to raise L arm above head due to pain. consult with MD. ice pack, rest, otc analgesics recommended. Phoned pt next day: minimal improvement. recommended f/u w MD.  Spoke with pt on 10/13/05. pt stated improved mobility: able to raise arm above head but stated arm still painful. pt had not seen medical provider.pt missed two days of work.									Y	10/10/2005	10/10/2005	0		UNK	UNK	synthroid		allergies: codeine pmh:rheumatoid arthritis/hypothyroidism			1						1	Hypokinesia; Injection site warmth; Pain; Swelling	FLU3~SANOFI PASTEUR~u1754aa~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0887p~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245435	10/14/2005	NC	54.0	54		F	10/14/2005	Rapid heart rate, hives to right arm, hoarseness, throat tightening.				Y					Y	10/13/2005	10/13/2005	0	None	UNK	UNK		none				1						1	Dysphonia; Heart rate increased; Throat tightness; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA153AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0245436	10/14/2005	PA	0.6	0	.6	M	10/14/2005	CHILD DEVELOPED HIGH FEVER AT 3AM. BECAME VERY IRRITABLE. WAS ADMITTED TO HOSPITAL FOR R/O SEPSIS.				Y	Y				U	10/13/2005	10/14/2005	1		UNK	UNK		NONE	NONE			1						1	Irritability; Pyrexia; Sepsis	FLU3~SANOFI PASTEUR~U1743IA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0245439	10/14/2005	TX	75.0	75		F	10/14/2005	ON 10-14-2005 PATIENT RETURNED TO PHARMACY FOR ANOTHER RX AND TOLD ME OF REACTION.  INJECTED UPPER ARM WAS VERY RED AND SWOLLEN. PATIENT REPORTED IT WAS VERY TIGHT BUT SWELLING HAD GONE DOWN AND SHE WAS IMPROVING.									Y	10/12/2005	10/12/2005	0	PATIENT WENT TO PHYSICIAN BUT I DO NOT KNOW WHAT TRANSPIRED THERE.	UNK	UNK	TOPROL XL, COUMADIN, TEMAZEPAM, FEREX 150	NONE	NONE KNOWN TO ME			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U1806AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245449	10/14/2005	MA	79.0	78		M	10/14/2005	10/07 c/o feeling of nausea about 8pm after supper. Pt reports developed temp of 108 F shaking , chills. Temp decreased to 106 rashy 10/08 am. C/O vomiting, diarrhea and shaking chills. 10/9 Temp 103 to 100. By 10/10 temp 99, feeling better. 10/11 afebrile, full recovery per pt. Patient did not call HCP for evaluation.									Y	10/07/2005	10/07/2005	0		OTH	PUB	Simvastatin, metformin, glipizide, fosinopril.	NONE	Diabetes type II, Hypertension, Hyperlipidemia, B12, Anemia			1						1	Chills; Diarrhoea; Nausea; Pyrexia; Rash; Tremor; Vomiting	FLU3~SANOFI PASTEUR~U1819AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245450	10/14/2005	OK	30.0	30		F	10/14/2005	11/11/2005 7:00 arm red, inflamed, warm to touch approx size 1 dm. 11/12/05 joint achiness, no fever, no H/A, mild nausea, fatigue, redness, swelling 3 dm to arm. 11/13/2005 same symptoms but intensified, BP increased, itching to left arm receiving treatment.				Y					U	10/11/2005	10/11/2005	0	NONE	PUB	PVT	NONE		NONE			1						1	Arthralgia; Blood pressure increased; Fatigue; Feeling hot; Hypersensitivity; Injection site inflammation; Nausea; Oedema; Pruritus	FLU3~SANOFI PASTEUR~U1761AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245451	10/14/2005	TX	4.0	4		F	10/14/2005	Mild swelling, erythema.				Y					U	10/12/2005	10/12/2005	0	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Erythema; Oedema	DTAP~SMITHKLINE BEECHAM~AC14B002BA~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1805AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y03432~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0194R~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0245452	10/14/2005	NY	72.0	72		F	10/06/2005	Red rash, hives like area itching on arms and legs, took 25mg Benadryl lasted x 3 days.									Y	10/05/2005	10/05/2005	0		PVT	UNK			Multiple drug allergies, HTN, Degenerative Joint Disease, Rheumatoid Arthritis, Glaucoma, Hyperlipidemia			1						1	Hypersensitivity; Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U1793AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245453	10/14/2005	CA	43.0	42		F	10/14/2005	Itchy throat, shortness of breath, chest tightness, given Benadryl 50mg 1M- resolved and AC'D from ER at 1855.				Y					Y	10/12/2005	10/12/2005	0	NONE	PUB	UNK	NONE	NONE				1						1	Chest discomfort; Dyspnoea; Pruritus; Chest discomfort; Dyspnoea; Pharyngolaryngeal pain; Pruritus	FLU3~SANOFI PASTEUR~U1803AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1803AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0245454	10/14/2005	CA	54.0	54		F	10/14/2005	Developed sore throat and general malaise approx 6 hours after injection. No SOB, no rash, no weakness, no treatment given.				Y					Y	10/12/2005	10/12/2005	0	NONE	PUB	UNK	UNK					1						1	Malaise; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U1803AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245455	10/14/2005	CA	56.0	55		F	10/14/2005	Felt tingling in left arm and shoulder and leg, general malaise. NO SOB, no weakness, no egg allergies, no treatments given.				Y					Y	10/12/2005	10/12/2005	0	NONE	PUB	UNK	UNK	NONE				1						1	Malaise; Paraesthesia; Malaise; Paraesthesia	FLU3~SANOFI PASTEUR~U1803AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1803AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0245456	10/14/2005	CA		50		F	10/14/2005	Generalized Malaise, headache, fever.									Y	10/12/2005			NONE	PUB	UNK		NONE				1						1	Headache; Malaise; Pyrexia	FLU3~SANOFI PASTEUR~U1803AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245457	10/14/2005	GA	79.0	79		F	10/14/2005	Injected flu vaccine into patients deltoid, pulled out needle pt started to bleed. While cleaning area and applying band aid a lump about the size of a nickel and raised c-4 cm came up on pts arm at site of injection. Pt stated it was very painful. Advised to apply ice and take Tylenol.									U	10/14/2005	10/14/2005	0	NONE	OTH	PUB		NONE	NONE			1						1	Injection site haemorrhage; Injection site induration; Injection site pain; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA142AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0245458	10/14/2005	GA	51.0	51		F	10/14/2005	Pt developed pus inside a big welt. Was admitted to the hospital to drain welt, still in hospital as of 10/14/2005, pt is fine, right arm cellulitis per Dr office 10/14/2005. 11/1/05 Review of d/c summary confirms diagnosis of R deltoid cellulitis s/p flu & pneumococcal vaccines. Treated with Vancomycin. Per annual report-10/17/05 per telephone follow up to vaccine providers, both vaccines were administered in the R arm. The site of the cellulitis.					Y	5			U	10/07/2005	10/09/2005	2		UNK	PUB	Insulin		Asthma, Diabetes. 11/01/05 Per review of D/C summary, additional pre-existing diagnosed conditions include thyroid cancer, chronic tracheostomy secondary to tracheal stenosis resulting from acute respiratory distress syndrome, and asthma/COPD.			1						1	Cellulitis; Urticaria	FLU3~SANOFI PASTEUR~U1811AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0245441	10/15/2005	ID	45.0	45		F	10/15/2005	Patient returned to pharmacy 2 days after injection, with red and warm area around right arm injection site.  I recommended her to see a physician.  Patient reported that they thinks this is minor celluitis or an allergic reation.  Patient was placed on Keflex 500mg 1tid x 10days.				Y					U	10/12/2005	10/14/2005	2		UNK	UNK	Unknown	None	Unknown			1						1	Cellulitis; Hypersensitivity; Injection site erythema; Injection site hypersensitivity; Injection site warmth	FLU3~SANOFI PASTEUR~U1811AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0490P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245444	10/16/2005	WA	61.0	60		M	10/16/2005	After getting a company work assignment, my wife and I purchased the current flu vaccinations from a local drugstore.    Three days later, at 3:00 A.M., I was awakened by extreme pain in my neck.  The pain was such that I could not move, even the slightest, as even a movement tiny as a hair would create super intense pain in my neck.  Actually, it was a bit frightening because of not being able to move; even the tiniest movement brought excruciating pain to my neck.  After a time the intenseness subsided, however, the next few days movement in my neck was restricted by pain.  To this day (4 years later) I do not have the free neck movement I enjoyed prior to this experience.  A few months later I went to a dermatologist to check on some red blotches in different areas of my body.  I had had these skin blotches for many years without knowing what they were.  The dermatologist took one look and advised me I have eczema.  He gave me some topical cream to apply to the blotches.  A few days later in discussing this event - flu shot with eczema - a colleague at work described a similar situation with one of his family members.  He said they were advised to never get another flu shot again as it could be severe the next time.  Since that event in 2001, I have discontinued getting flu  shots for fear of re-experiencing such intense pain in my nect again in addition to fear of losing move free movement in my neck.  I do not know the specifics about the vaccine, i.e., manufacturer, type, or even the nurses who gave the shots.    I only submit this in order to help others with similar eczema symptoms as well as seeking information so that I may avoid similar experiences in the future.									Y	09/01/2001	09/04/2001	3		UNK	UNK		none	later discovered i have eczema and have had this for years without realizing it.			1						1	Erythema; Neck pain; Rash macular	FLU3~PARKDALE PHARMACEUTICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0245446	10/16/2005	NM	39.0	39		F	10/16/2005	apx 20 hours after administered a site reaction was noticed including redness, swelling, soreness and area was hot to the touch.  A moderated fever was present at this time and continued to increase.  Within 48 hours all over stiffness and body aches, lasting several days. Most alarming for the pt was a remarkable change of mood and behavior, including irritablity, hostility and aggression that has been increasing as of 10/12/05 and has not subsided with the stiffness and soreness.				Y						10/10/2005	10/11/2005	1	none to date	UNK	UNK			penicillin allergy			1						1	Abnormal behaviour; Aggression; Hostility; Injection site erythema; Injection site pain; Injection site reaction; Injection site swelling; Injection site warmth; Irritability; Mood altered; Musculoskeletal stiffness; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0245447	10/16/2005	MD	77.0	77		F	10/16/2005	Left arm sore, swollen and red to mid forearm. Jowls amd left cheek swollen. Small bisters on back of left arm				Y					N	10/12/2005	10/12/2005	0	None	UNK	UNK	Lisinopril Toprop XL Actonel Aciphex	None	High Blood pressure			1						1	Blister; Erythema; Face oedema; Pain; Swelling	FLUX~UNKNOWN MANUFACTURER~U1836~7+~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~0746P~1~IM~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0245459	10/17/2005	AK	28.0	28		M	10/13/2005	Rapid onset of flu symptoms ( chills, fatigue, mild dehydration, fever , 102.5 F temp at 6:30pm 10/10/2005. Spiked pm on 10/11/2005. Asymptomatic on 10/12/2005. Reaction not observed by health center.				Y					Y	10/10/2005	10/10/2005	0		PUB	UNK		NONE	NONE			1						1	Chills; Dehydration; Fatigue; Influenza like illness; Pyrexia	FLU3~SANOFI PASTEUR~U1558AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245460	10/17/2005	OR	57.0	57		F	10/15/2005	The injection sites are swollen, hot and red. The reactions occur after 28-30 hours. The flu and pneumococcal vaccines were given on the same arm on Wednesday 10/12. Patient took 1 Benadryl tab 25mg on Thursday night. She came in my pharmacy the next day, I instructed her to do ice pace and take Advil, ask to call back.									Y	10/12/2005	10/13/2005	1	NONE	UNK	OTH	NONE					1						1	Injection site hypersensitivity; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U1805AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~579P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245461	10/17/2005	TX	77.0	77		F	10/08/2005	Red, hot, swelling (right arm Pneumonia shot), fever 102F and 99.8F, Treatment Tylenol 500 mg, clindamycin 150 mg.				Y					Y	10/07/2005	10/08/2005	1		OTH	PVT						1						1	Injection site hypersensitivity; Injection site oedema; Injection site reaction; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U1806AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245462	10/17/2005	CA	59.0	58		F	10/05/2005	Itchy hands, blotches spreading from hands to trunk. Hands burning, developed slight tightness in chest.									U	10/03/2005	10/03/2005	0		PVT	UNK	Albuterol inhaler, corbivent inhaler.		Asthma			1						1	Chest discomfort; Pruritus; Rash macular; Skin burning sensation	FLU3~SANOFI PASTEUR~U1811AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245476	10/17/2005	NJ	52.0	52		M	10/13/2005	A 52 year old female patient with medical history of myocardial infarction, congestive heart failure, insulin dependant diabetes mellitus, chronic obstructive pulmonary disease and respiratory failure admitted in a hospital on Oct 03 2005 for the treatment of mental changes and also for all the above mentioned diseases. According to the hospital standing orders patient was given influenza vaccine (Fluzone SV 2005 2006) on Oct 5 2005 and the next day, patient developed decreased muscle reflexes in both lower extremities and increased respiration on ventilator. Neurological consultation was pending to rule out Reyes syndrome at the time of the report. CAT scan and LST performed at an unspecified time was normal but LST ap showed no bacteria but positive glucose. As concomitant treatment she was receiving aspirin and she refused to take insulin for diabetes. Outcome was not reported.				Y						10/05/2005	10/06/2005	1	CAT scan and LST: normal, LST ap: negative bacteria, positive glucose.	PVT	UNK			MI, CHF, IDDM, COPD, and respiratory failure		200502021	1						1	Abnormal behaviour; Blood glucose increased; Hypoxia; Muscle disorder; Respiratory rate increased	FLU3~SANOFI PASTEUR~U1833BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245477	10/17/2005	CT	5.0	4		M	10/13/2005	On 04 year old male child pt with no reported medical history and was in good condition at the time of the vaccination experienced bilateral leg pain in entire limbs with subsequent loss of reflexes on 02Oct05, i.e 5 days following influenza vaccine (Fluzone SV 20052006), lot no: U1804AA, administration. The pt was admitted overnight at an unspecified time in an hospital for observation. Neurological diagnosis was neuralgia. Reflexes returned to normal, pt was recovering but the outcome was unk at the time of the report.					Y				U	09/27/2005	10/02/2005	5		PVT	UNK			NONE		200502029	1						1	Hyporeflexia; Nervous system disorder; Neuralgia	FLU3~SANOFI PASTEUR~U1804AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0245481	10/17/2005	CA		57		F	10/14/2005	Pt would like to remain anonymous as the reporter so that the doctor doesn't know she filed the complaint. Pt complains of soreness at injection sites however had serious pain on left arm, it was also hot, discomfort such that couldn't sleep at night or move left arm at all by next day. Blisters at injection site also appeared and extended through the back of the neck. Had a horrendous case of flu next day with headache, nausea, chills, coughing. No medication taken. Evening of 2nd day bad case of flu starting to recover, symptoms subsiding. Left arm muscles are paralyzed and right arm just sore. Monday hand and arm numb, unable to close fingers. The blisters are now on abdomen, upper breast, shoulder neck and more are appearing. Blisters ooze liquid.									N	10/07/2005	10/07/2005	0		OTH	PUB	Pt did not want to provide this info	NONE	Arrhythmia, thyroid problems.	respiratory~Td Adsorbed (no brand name)~~55.00~In Patient		1						1	Blister; Chills; Cough; Fluid retention; Headache; Hypoaesthesia; Hypokinesia; Influenza like illness; Injection site pain; Nausea; Paralysis; Sleep disorder	FLU3~SANOFI PASTEUR~1771AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0791D~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245482	10/17/2005	WA	29.0	29		F	10/11/2005	Headache about 1 hr at shot, stomach ache around 5PM. Vomit and diarrhea started at 2:00AM still present at time chills.										10/10/2005	10/10/2005	0		OTH	OTH		NONE				1						1	Abdominal pain; Chills; Diarrhoea; Headache; Vomiting	FLU3~SANOFI PASTEUR~U1818AB~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245483	10/17/2005	WA	50.0	49		F	10/11/2005	Redness and soreness at the site, upper respiratory symptoms like diff breathing, sore throat, running nose and sneezing non stop, aches, dizziness.										10/10/2005	10/11/2005	1	99.7F, 50x50mm erythema, heat.	UNK	UNK						1						1	Dizziness; Dyspnoea; Erythema; Feeling hot; Injection site erythema; Injection site pain; Myalgia; Pain; Pharyngolaryngeal pain; Pyrexia; Respiratory disorder; Rhinorrhoea; Sneezing	FLU3~SANOFI PASTEUR~U1818AB~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245484	10/17/2005	GA	83.0	82		F	10/13/2005	NONE									U	10/11/2005	10/13/2005	2		PVT	PVT	Premarin, Maxzide	NONE	Arthritis			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~41794AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1006P~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245485	10/17/2005	MI	62.0	62		F	10/12/2005	PVP 0.5ml administered Mon. 10/10/05 right arm. Approx 7 hrs post injection arm felt warm and next morning c/o arm stiffness and soreness of arm. Denies fever c/o chills. No redness or tenderness noted at injection site. Instructed to put ice to area and call Dr. 2 lg red raised areas noted firm to touch on front and back of upper arm (no redness, tenderness or edema noted at site of injection). Appt made with family physician for 10/13/05. Instr by Dr to cont with ice and use Motrin or Tylenol until seen.									U	10/10/2005	10/10/2005	0		OTH	PVT	NONE	NONE	NONE			1						1	Feeling hot; Injection site pain; Injection site swelling; Musculoskeletal stiffness; Oedema	FLU3~SANOFI PASTEUR~U1846AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0791P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245486	10/17/2005	WA	65.0	65		F	10/07/2005	Same evening as injection was given Pt noticed inj site became red. By the next day the site was also hot and sore, and more red. Pt did not treat.				Y					U	10/04/2005	10/04/2005	0		PVT	PVT	Actonel, Atenolol, Premarin crm	NONE	PCN hives	~Td Adsorbed (no brand name)~1~58.00~In Patient		1						1	Feeling hot; Injection site erythema; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~127AB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0709P~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245494	10/17/2005	GA	72.0	72		F	10/17/2005	Received flu and pneumonia vaccine on 10-14-05. Both vaccines given in same arm due to pt preference. Pt noticed Left upper arm was red on 10-17-05. Area is approximately 3 inches by 2 inches on lower portion of upper arm. Is below where shots would have been given. Area red and warm to touch. No swelling noted.									U	10/14/2005	10/17/2005	3		UNK	UNK	Unknown	None reported by pt	NKA, is disabled and walks with a cane			1						1	Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U1762AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245495	10/17/2005	SC	42.0	42		F	10/14/2005	Within 10 minutes I had inflammation surrounding the shot site and had hives all over. The nurses who were administering the shots told me to place a cold compress on the site and take Benedryl. Once I did that the hives went away. Then, again the next afternoon I got another case of hives on the arm where I got the shot.  I have no known allergies, so this was quite unexpected for me. I've also gotten flu shots over the years with no reaction.									Y	10/14/2005	10/14/2005	0		UNK	UNK						1						1	Injection site inflammation; Urticaria	FLU3~SANOFI PASTEUR~U1763AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245496	10/17/2005	FL	72.0	71		F	10/17/2005	Seen in our ER 2 days after vaccination with Pneumovax (not sure where she received it) c/o pain, edema and erythema at vaccine injection site (left arm). Erythema and edema initially extended from shoulder to elbow. When patient presented to ER, erythema and edema still persisted lower half of upper arm. Afebrile in ER (temp of 98.1). Rated her pain as 3/10 and described pain as burning. MD diagnosis states Acute Cellulitis after Pneumovax. Treatmentin ER included Zithromax 500 mg PO and Decadron 8 mg PO. Also given prescriptions for Zithromax Z-Pak & Decadron.				Y					U	10/11/2005	10/11/2005	0	Seen by ER MD for exam. No labs done.	UNK	UNK	Lipitor, Tylenol, Cortisone Cream	None reported	Lyme Disease, CAD, Smoker (1PPD), + alcohol intake, IBS; Allergic to PCN; Patient gave history of previous Pneumovax vaccination prior to this year; history of previous PICC line insertion in arm that developed the cellulitis post pneumovax vaccine.			1						1	Cellulitis; Injection site erythema; Injection site swelling; Pain; Vaccine positive rechallenge	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245497	10/17/2005	FL	76.0	75		F	10/17/2005	Patient c/o pain and swelling right mid to upper arm following pneumovax vaccination. Described pain as constant, throbbing, rated pain as 6/10.				Y					U	10/01/2005	10/01/2005	0	No labs done.	UNK	UNK	Diovan	No other illness reported.	No known allergies. History of hypertension, hysterectomy, appendectomy, history of UTI x 2 (hard to read MD writing on this), knee arthroscopy, occasional intake of alcohol			1						1	Pain; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245498	10/17/2005	NY	60.0	60		F	10/17/2005	EMPLOYEE RECEIVED FLUZONE 0.5ML IM AT APPROX 8AM 10/14/05. aT APPROX 1 PM DEVELOPED COUGH, FEELING OF SHORTNESS OF BREATH. SEEN IN EMERGENCY DEPARTMENT, HAD NEBULIZER TREATMENT AND RETURNED TO WORK.				Y					Y	10/14/2005	10/14/2005	0	NONE	UNK	UNK	HCTZ	NONE	HYPERTENSION NO KNOWN ALLERGIES PAST HX FLU VACCINE WITHOUT PROBLEM			1						1	Cough; Dyspnoea	FLU3~SANOFI PASTEUR~U1753AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245499	10/17/2005	FL	74.0	73		F	10/17/2005	Patient c/o redness, pain and swelling in left arm persisting 3 days after Pneumovax & influenza vaccines (unknown if one/both vaccinations were  given in left arm).				Y					U	10/10/2005	10/10/2005	0	No labs done.	UNK	UNK	Synthroid	None reported.	No known allergies. History of thyroid condition & left frozen shoulder.			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245500	10/17/2005	TX	18.0	18		F	10/17/2005	Patient received flu vaccination on afternoon of 10/14/05.  She stated the rash started a couple of hours after the shot was given.  The rash consists of welts on various parts of her body that she says itches.  She denied having difficulty breathing or other signs or symptoms.  She showed the rash to me, her school nurse, on Monday morning around 10:00 AM.									Y	10/14/2005	10/14/2005	0		UNK	UNK			Patient is approximately 7 months pregnant.			1						1	Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U1805AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245501	10/17/2005	CA	51.0	51		F	10/17/2005	Immediate pain at site. Within 12 hours swelling, redness and pain at site with numbness and tingling down left arm/hand and that evening, wheezing and SOB. Within 24 hours of injection, wheezing and SOB better but left arm with numbness,and underarm pain and SEVERE swelling of lymph nodes affecting whole underarm, breast area. Now Monday, 10/17 not quite 36 hours with decreased swelling but still underarm sensitivity, pain and swelling.									Y	10/14/2005	10/14/2005	0		UNK	UNK						1						1	Dyspnoea; Hypoaesthesia; Injection site erythema; Injection site pain; Injection site swelling; Lymphadenopathy; Paraesthesia; Wheezing	FLU3~SANOFI PASTEUR~U1754AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245502	10/17/2005	FL	1.95	1	.9	M	10/17/2005	Received flu vaccine in his doctor's office on 10/14/2005. No adverse effects described that evening. Found dead in bed the following morning. Autopsy was performed; results are pending. 3/30/06 Autopsy Report received which stated COD as undetermined.	Y	10/15/2005							N	10/14/2005	10/15/2005	1	None available yet	UNK	UNK	None other than Children's Advil given after immunization	None	None			1						1	Unevaluable event; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~U1775AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0245507	10/17/2005	TX	24.0	23		F	10/17/2005	AS PER MOTHER'S INFORMATION, PATIENT BEGAN HAVING  HEADACHES AND FLU LIKE SYMPTOMS WITH THE INFLUENZA VIRUS VACCINE SHE RECEIVED 10/13/05 AT HER PLACE OF WORK.  THE HEADACHES BECAME WORSE AND THE PATIENT BEGAN EXERIENCING NAUSEA AND VOMITING WHICH PROMPTED HER TO GET MEDICAL HELP 10/17/05 AT OUR FACILITY.  AS PER THE PATIENTS MOTHER'S STATEMENT, THE PATIENT RECEIVE THE INFLUENZA VIRUS VACCINE LAST YEAR WITHOUT A PROBLEM.  THE VACCINE SHE RECEIVED 10/13/05 DID CAUSE A REACTION. SHE BEGAN EXPERIENCING A  RASH TO HER NECK AND THE SITE AS PER HER SUPERVISOR AT HER PLACE OF WORK. AS PER THE ADMITTING RN AT OUR FACILITY,  THE PATIENT IS NOT ALLERGIC TO EGG OR EGG CONTAINING PRODUCTS. SHE HAS NO HISTORY OF GUILLIAN BARRE. SHE HAS NO HISTORY OF OTHER DISEASES. Infroation received from medical records states malaise, blood short eyes, ecchymosis. msv Information from discharge summary states thrombocytopenoia, hemoptosis, hematemesis, hematuria, impaired thinking. msv Medical records states cardiomegely, cholelithiasis, pulmonary edema, perepherial edema, vascular anomaly. msv					Y				Y	10/13/2005	10/14/2005	1	Information received from medical records includes anemia, hematuria, abnormal lab tests, liver envimes increased, thrombocytopenia. msv	UNK	UNK		NONE AS OUR FACILITY RN INFO GIVEN TO HER	NONE AS PER OUR FACILITY RN INFO Discharge summary states blood dyscrasia. msv			1						1	Anaemia; Aspartate aminotransferase increased; Cardiomegaly; Ecchymosis; Eye haemorrhage; Haematemesis; Haematuria; Haemoptysis; Headache; Influenza like illness; Injection site rash; Laboratory test abnormal; Malaise; Mental impairment; Nausea; Oedema peripheral; Pulmonary oedema; Rash; Thrombocytopenia; Vascular anomaly; Vomiting; Injection site rash; Rash; Thrombocytopenic purpura	FLU3~SANOFI PASTEUR~U1744AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1744AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0245514	10/17/2005	CA	9.0	8		M	10/17/2005	Hives 8 hours after FluMist administered intranasally.									Y	10/08/2005	10/08/2005	0		PVT	PVT	Zithromax	Bronchitis 10/04/05.	Reactive airway disease with infection.			1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500388P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0245512	10/18/2005	CA	90.0	90		M		Rash, no fever.									U	10/07/2005	10/11/2005	4	NONE	PVT	PVT	Actos; Metaprolol; Plavix; Prevacid	Diabetes mellitus, Hypertension	Hypertension, Diabetes Mellitus			1						1	Rash	FLU3~SANOFI PASTEUR~U1777AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245522	10/18/2005	UT	0.17	0	.2	F	10/07/2005	Safety and Immunogenicity of Fluzone Influenza virus vaccine (2005-2006 formulation) among healthy children 6 to 12 weeks of age. Initial report received on 30Sep05 from an investigator participating in the above mentioned trial. A two month old female subject developed generalized hives/urticaria and a left swollen ear and was diagnosed with an allergic reaction 10 to 20 minutes after receiving an IM injection of Fluzone No preservative 2005-2006, lot number UD07402, or Placebo in the right thigh on 30Sep05. The subject had no reported medical history. She was treated with Benadryl and Tylenol per os. Her oxygen saturation level was 97% to 98%. The pt recovered from the events. Documents held by sender: physician's office note.				Y					Y	09/30/2005	09/30/2005	0		UNK	UNK					200501961	1						1	Ear disorder; Hypersensitivity; Oedema; Urticaria	FLU3~SANOFI PASTEUR~UD07402~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245523	10/18/2005	CA	16.0	15		F	10/18/2005	Fever, rash on chest/back. Temp to 102, achy.				Y						10/13/2005	10/17/2005	4		PVT	PVT						1						1	Pain; Pyrexia; Rash	FLU3~SANOFI PASTEUR~41753AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245524	10/18/2005	NC	79.0	78		F	10/11/2005	Right deltoid pain for 1 week, no redness, no swelling, no knot.									Y	10/03/2005	10/06/2005	3	NONE	PUB	PUB	NONE	NONE	NONE		NC05090	1						1	Pain	FLU3~SANOFI PASTEUR~U1794AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245525	10/18/2005	MO	73.0	72		F	10/07/2005	Client called stating symptoms of dizziness, bad taste in mouth. Just feel different. Advised client to return. BP taken 92/60, Pulse 72. Client was concerned. Referred to emergency room. Patient history of Diabetes, heart problems, high blood pressure.				Y						10/07/2005	10/07/2005	0		PUB	PUB	Atenolol; Actos; ASA	NONE	Diabetes; HBP; Heart Condition			1						1	Dizziness; Dysgeusia	FLU3~SANOFI PASTEUR~U1744AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245550	10/18/2005	PA	40.0	40		F	10/18/2005	Approx 1/2 hors after getting flu vaccine right deltoid came back to OCC Med complaining of numbness left side of mouth, tongue. Laid down BP 110/70, P60, R20. Fell asleep about 8:50 retook BP 12/80, P72, R20, then had drooling left side of mouth and slurred speech. To ER also noticed had hives down left arm. Telephone F/U with reporter 10/19/05: Final diagnosis was anaphylaxis - reaction to flu vaccine.				Y					Y	10/18/2005	10/18/2005	0	Lab work, CT head, Urine test EKG, medicated with Solumedrol, Benadryl, prednisone. Discharged to home.	OTH	PVT		NONE	NONE			1						1	Anaphylactic reaction; Drooling; Dysarthria; Electrocardiogram; Hypoaesthesia; Scan brain; Urine analysis; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA123BC~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0245551	10/18/2005	MO	72.0	72		M	10/10/2005	Spoke with wife who gave information on patient. Pt c/o hurting arm immediately after shot, which is no unusual, but later arm worsened and could not lift over head, Called MD who prescribed Celebrex. Has taken all weekend not any better. To call MD again today.				Y					U	10/05/2005	10/05/2005	0	NONE	PUB	OTH	BP medication	NONE	High blood pressure			1						1	Hypokinesia; Pain	FLU3~SANOFI PASTEUR~A~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245552	10/18/2005	OR	45.0	45		F	10/07/2005	Shot received 3:45pm 10/04/2005. By 8pm generalized over all feeling of not feeling well. Started getting chills and body aches from 9pm - 12:30am. When I took my temp 100.2. Took some Tylenol to try to reduce fever, went back to bed. Fever broke at around 5am. Had rash from shot site to under arms, around neck, across to under breast. Next day with tongue swelling and soreness and throat swelling. Had a cough like something was stuck in my throat the evening after shot.				Y					N	10/04/2005	10/04/2005	0		PVT	PVT	Novco, Ambien, trazodone.	NONE	Fibromyalgia			1						1	Chills; Cough; Malaise; Pain; Pharyngeal oedema; Pyrexia; Rash; Tongue oedema	FLU3~SANOFI PASTEUR~U1754AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245553	10/18/2005	OH	74.0	74		F	10/07/2005	Right arm 20 x 30 erythema, edematous plague, left arm 4 x 4cm erythema, edematous plague, with 2 hrs became red, swollen. Better 24 hrs later.									N	10/05/2005	10/06/2005	1	NONE	PVT	PVT	ASA, Lisinopril. Evista.					1						1	Erythema; Hypersensitivity; Oedema	FLU3~SANOFI PASTEUR~U1762AA~5~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0691P~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245554	10/18/2005	IL	1.61	1	.6	M	10/11/2005	Large hive developed at injection (DTaP) site within a few minutes of administration. Benadryl 1 tsp given. Observed in office 1/2 hour before discharge.									Y	10/11/2005	10/11/2005	0	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Injection site reaction; Urticaria	DTAP~SANOFI PASTEUR~C2254AA~4~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1743KA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0460~3~SC~LA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0245555	10/18/2005	IL	54.0	54		U		Itching to trunk and all 4 extremities 3 hours after flu shot administration. No angioedema, no visible rash, lung clean pulse ox 98%.									N	10/10/2005	10/10/2005	0		PUB	UNK		Hypertension (controlled)	History of Hypertension, GERD,			1						1	Pruritus	FLU3~SANOFI PASTEUR~U1761AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245556	10/18/2005	MI	31.0	31		F	10/11/2005	Wheezing onset 2pm, aching 3pm - next am, fever 101 + approx 5pm, Gone in am.									Y	10/03/2005	10/03/2005	0		PUB	UNK						1						1	Pain; Pyrexia; Wheezing	FLU3~SANOFI PASTEUR~U1846AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245558	10/18/2005	NC	1.24	1	.2	M	10/05/2005	7-10 days after vaccines, pt developed a fever and had a seizure. Went to ER test run, then came to our office on 10/04/2005.				Y					Y	09/22/2005	10/01/2005	9	Completed at ER on 10/01/2005, Chest x ray, UA, BMP, CBC with DIFF. Blood culture.	PVT	PUB					NC05089	1						1	Convulsion; Pyrexia	FLU3~SANOFI PASTEUR~U1755AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0343R~4~IM~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0609P~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A6563F~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0522R~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0245565	10/18/2005	GA	68.0	67		F	10/17/2005	Red, swollen area to right arm, at injection site down to bend of arm (elbow).									Y	10/14/2005	10/15/2005	1		MIL	PUB		NONE	NONE			1						1	Injection site hypersensitivity; Injection site oedema	FLU3~SANOFI PASTEUR~U1762AA~6~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~4~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245583	10/18/2005	SC	68.0	67		F	10/13/2005	Was given Pneumo and flu shot on Monday Oct 10 developed soreness (pain in upper arm) Monday evening, Tuesday AM deltoid area swollen, red, warm, tender to touch, no fever, but having body aches.										10/10/2005	10/10/2005	0	Given Levaquin 500 1 PO qd x 7 days. Cold compress and Aleve 2 PO Bid.	PVT	OTH	Tenoretic 50/25	NONE	Osteoporosis, hyperlipidemia, HTN.			1						1	Feeling hot; Injection site erythema; Injection site oedema; Injection site pain; Myalgia; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~122AB~1~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0605R~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245586	10/18/2005	FL	57.0	57		F	10/18/2005	Received shot on Thursday, 10/6/05.  Awoke on Sat with generalized muscle and joint aches, sinus congestion, sore throat, ear ache.  Did not have a fever. Stayed in bed all day and took acetaminophen.  Felt somewhat better on Sunday and recovered on Monday.									Y	10/06/2005	10/08/2005	2	none	MIL	MIL		No illness	none			1						1	Arthralgia; Ear pain; Myalgia; Nasal congestion; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U1829AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245587	10/18/2005	KS	54.0	54		F	10/17/2005	Swelling in throat, intense back pain, headache, secretions from eyes, flu symptons.  Patient suspects Thimersol, which she is hypersensitive to. Doctor prescribed prednisone.  Patient is to see her doctor within 24 hours.				Y					U	10/17/2005	10/17/2005	0		UNK	UNK		None	None			1						1	Back pain; Eye discharge; Headache; Influenza like illness; Pharyngeal oedema	FLU3~SANOFI PASTEUR~U1763AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245590	10/18/2005	CA	29.0	28		F	10/18/2005	Vaccine was given in my left arm and immediately developed a hard, red, hot lump and remained in this condition.  Late friday night the lump started to break down and a rash began to form.  Rash was raised, red streaks (lines of varying length) that covered my anterior left arm, lateral left breast and torso, none on abdomen or left hip, some on left lateral thigh.  Still fading, but present today.									U	10/12/2005	10/14/2005	2	none	UNK	UNK	Albuterol-as needed	Ear infection	Asthma			1						1	Injection site erythema; Injection site induration; Injection site mass; Rash; Skin striae	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0245591	10/18/2005	IL	43.0	43		F	10/18/2005	10/14/05 - Received vaccine at approx. 1:30pm.  By that evening, c/o soreness in left arm. 10/15/05 - at approx. 1:30pm - c/o cold chills, fever 101F, achy bones, left upper arm swollen and red/ hot to touch.   10/16/05 - Continued with c/o's from previous day and also c/o severe bone aches in arms and legs.   10/16/05 - Was seen in Emergency Room in the evening.  Diagnosed with cellulitis in left arm and treated with Levaquin by mouth.  Left arm was swollen to the size of an orange, painful to move and hot to touch.  10/17/05 - Was seen by her primary physician at approx. 3pm.  Dr diagnosed her with a severe reaction to pneumonia shot - Dr did not diagnose her with cellulitis.  She was continued on Levaquin and also given Palgic and Ibuprofen. 10/18/05 - Swelling at injection site now size of a dime with redness.  Continues to c/o soreness and body aches.   Did visit ER and Dr's office.  Is missing second day of work today.				Y					U	10/14/2005	10/15/2005	1	Elevated WBC count.	UNK	UNK	synthroid, toprol, generic lasix, elapril	none	allergic to morphine and oxycodone			1						1	Bone pain; Cellulitis; Chills; Erythema; Hypokinesia; Injection site reaction; Injection site warmth; Pain; Pyrexia; White blood cell count increased	FLU3~SANOFI PASTEUR~U1838AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245596	10/18/2005	MS	18.0	18		F	10/18/2005	Pt given Flu-mist approx 15-20 mins later she felt flushed, dizzy, and warm. During observation she developed a slight tightening of the chest and was given an EPI pen inj and transported to the clinic via ambulance. Remained stable and was released about an hour and half later.				Y					Y	10/13/2005	10/13/2005	0		MIL	MIL		NONE	NONE			1						1	Chest discomfort; Dizziness; Feeling hot; Flushing	FLUN3~MEDIMMUNE VACCINES, INC.~500390P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0245601	10/18/2005	CO	71.0	71		F	10/18/2005	Patient complained of tingling tongue and numb lower lip about 10-15 minutes after immunization. RPh spoke with ptn., observed and administered 25mg Benadryl (po) at about 1 hour post imm. (Ptn declined 50mg so she could drive) No further signs of allergy but ptn. wsa concern so 911 called and EMT's checked BP & vitals and released ptn upon her signature and ER doctors verbal approval. Patient had flu shots in the past and had no history of allergic rxn to flu vaccine. We paged her PCP but did not receive a call back. Ptn went home on her own after shopping about 2 hours post imm.   Upon follow up there was no worsening of allergic like symptoms but the ptn did complain of flu like discomfort, but is now feeling fine (10/18/05).									Y	10/12/2005	10/12/2005	0		UNK	UNK	unknown	none	unk			1						1	Hypoaesthesia oral; Paraesthesia	FLU3~SANOFI PASTEUR~U1805AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245602	10/18/2005	WY	66.0	65		M	10/18/2005	Woke up early in morning next day after receiving PPV 23 and flu shots feeling sick, with difficulty raising R arm (arm that got PPV 23 shot), whole R side of body ached, swollen R axillary lymph nodes, redness and pain in underarm area.									Y	10/12/2005	10/13/2005	1		UNK	UNK	None	None	None			1						1	Erythema; Hypokinesia; Lymphadenopathy; Pain	FLU3~SANOFI PASTEUR~U1807AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245604	10/18/2005	FL	33.0	32		M	10/18/2005	I noticed that a day (10/14/05) after taking the Flu shot, I became very weak and tired. I waited to see if there would be any improvement but things got worse on the 18th of October. I because very sleepy, dizzy, and lost appetite. This was followed by severe back pains.  I had no choice than to go to the emergency room.				Y					U	10/13/2005	10/14/2005	1	Series of blood test were conducted and related prescriptions were administered.	UNK	UNK		None	None			1						1	Anorexia; Asthenia; Back pain; Dizziness; Fatigue; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0245611	10/18/2005	PA	33.0	32		F	10/18/2005	Flu and Pneumonia vaccines given 10/17/2005. Pt noted hives in afternoon 10/18/2005. Complained of hives on face neck, torso,extremities. Lips slightly swollen. Denies SOB, fever or difficulty swallowing. Dr ordered pt to take her routine allergy Meds (Allegra, Zantac).									N	10/17/2005	10/18/2005	1		PVT	PVT		Has history of hives	Allergies peanuts, seasonal allergies.			1						1	Face oedema; Urticaria	FLU3~SANOFI PASTEUR~U1819AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749D~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245612	10/18/2005	FL	63.0	63		F	10/14/2005	Redness, pain, warmth on day 2 after injection left deltoid. Pt referred for assessment with PCP.									U	10/12/2005	10/12/2005	0	NONE	PUB	PVT		NONE	NONE			1						1	Feeling hot; Injection site hypersensitivity; Injection site pain	FLU3~SANOFI PASTEUR~U1793AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245606	10/19/2005	TX	53.0	53		M		Local rash, swelling, itching, fever.				Y					Y	10/15/2005				PUB	OTH						1						1	Injection site oedema; Injection site rash; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~61806AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0191P~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245607	10/19/2005	TX	50.0	50		F	10/17/2005	Emotional, nausea, swelling at injection area.									Y	10/11/2005	10/11/2005	0		PVT	PVT		NONE				1						1	Emotional disorder; Injection site oedema; Nausea	FLU3~SANOFI PASTEUR~U1764AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245608	10/19/2005	TX	24.0	24		F	10/17/2005	Swelling and pain at injection area.									Y	10/11/2005	10/11/2005	0		PVT	PVT		NONE				1						1	Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U1764AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245609	10/19/2005	TX	61.0	60		M	10/17/2005	Nausea, dizziness, swelling at injection area.									Y	10/11/2005	10/11/2005	0		PVT	PUB			Codeine, Penicillin, sulfas, meperidine.			1						1	Dizziness; Injection site oedema; Nausea	FLU3~SANOFI PASTEUR~U1764AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245610	10/19/2005	TX	79.0	79		M	10/17/2005	Nausea, swelling at injection.									Y	10/11/2005	10/11/2005	0		PVT	PVT						1						1	Injection site oedema; Nausea	FLU3~SANOFI PASTEUR~U1764AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245628	10/19/2005	MN	56.0	56		M	10/19/2005	Fever within 12 hours, sore and ach within 24-36 hours.									Y	10/14/2005	10/16/2005	2		PVT	OTH						1						1	Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1756AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~0386P~1~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0245629	10/19/2005	MD		6		F	10/19/2005	Oral temperature of 101.7, headache, runny nose, Motrin taken. Symptoms subsided Monday. Went back to school on Tuesday.				Y					Y	10/14/2005	10/16/2005	2		PVT	PVT						1						1	Headache; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~UNK~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0245630	10/19/2005	ME		45		F	10/18/2005	Fever, hives, flushed face, general weakness, dizziness, lightheadedness. Took Tylenol but did not really help. Hives on arms and chest.				Y					N	10/17/2005	10/17/2005	0		PVT	PVT	Tumerol, Avapro.		Blood pressure, asthmatic problems steaming from Pneumonia 2 years ago.	hives~Rubella (no brand name)~~31.00~In Patient		1						1	Asthenia; Dizziness; Flushing; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U1746AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245635	10/19/2005	IL	1.35	1	.4	F	10/19/2005	8 days 10/13/2005 after vaccine administration child developed a red, slightly raised rash around mouth and fever 103. Was hospitalized  (hydro tic IV fluids) for 5 hours then released.				Y	Y	1			Y	10/04/2005	10/13/2005	9	Blood work done at hospital results unknown to this writer.	PUB	PUB	NONE	NONE	NONE			1						1	Hypersensitivity; Pyrexia; Rash erythematous	DTAP~SANOFI PASTEUR~C2183AA~4~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1805AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y02412~3~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0601R~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Hospitalisation	Influenza
0245641	10/19/2005	NY	8.0	8		M		Right deltoid area with erythema, tenderness, small pinpoint dot at injection site. right axillary lymph node palpable 2cm round mobile with erythema and tenderness. Instructed ice, Motrin PRN, ENC movement. Call with increased S/S. no UMP and PRN.									Y	10/10/2005	10/11/2005	1		PVT	PVT	Zyrtec, Nasonex NS.					1						1	Erythema; Injection site reaction; Lymphadenopathy; Tenderness	FLU3~SANOFI PASTEUR~U1746AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245642	10/19/2005	OR	5.0	5		M	10/13/2005	Local Redness, swelling a injection site, about 7cm x 10cm induration, warm to touch, soreness.									Y	10/12/2005	10/13/2005	1		PVT	OTH	Albuterol, Flovent.	Viral GE	Asthma, history of seizure.			1						1	Feeling hot; Injection site hypersensitivity; Injection site induration; Injection site oedema; Pain	FLU3~SANOFI PASTEUR~U1805AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245643	10/19/2005	TX	29.0	29		F	10/19/2005	Pt received flu shot for first time today about 15 mins after receiving medication in left arm. Left arm site became itchy and red. Patient has no C/O difficulty breathing or hives. Reaction is at local site only note. Given Benadryl 50mg PO advised. To call Dr or go to ER if symptoms persisted. 3:15 pm called client at home states no continued problems noted.									Y	10/19/2005	10/19/2005	0		UNK	PVT						1						1	Injection site hypersensitivity; Pruritus	FLU3~SANOFI PASTEUR~U1830AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245644	10/19/2005	WA		52		F	10/19/2005	Injection arm has severe  pain (nerve) that is constantly present and strength, movement significantly reduced, above elbow only.				Y					N	10/05/2005	10/08/2005	3		OTH	PVT	Lioinoprin, Armour thyroid	NONE	Herniated lumbar disc, Hypothyroid.			1						1	Hypokinesia; Neuralgia; Pain	FLU3~SANOFI PASTEUR~U1811AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245645	10/19/2005	CA	64.0	63		M	10/12/2005	About 10 minutes after getting Flu shot he began perspiring and stated just over all did not feel well. He received Epinephrine and Benadryl solumedrol. ER physician states could have been allergic reaction but could also have had a bradycardia dysrhythmia. ER summary states nausea, dyspnea, abnormal vision. msv				Y					Y	10/08/2005	10/08/2005	0	EKG sinus bradycardia rate 50, CBC normal, Chest x-ray normal, chem panel normal, cardiac enzyme negative.  ER Summary states anemia. msv	OTH	PVT	Atenolol, Aspirin	NONE	Hypertension			1						1	Anaemia; Bradycardia; Dyspnoea; Hyperhidrosis; Hypersensitivity; Malaise; Nausea; Sinus bradycardia; Visual disturbance	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA120BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0245647	10/19/2005	PA	40.0	39		F	10/13/2005	Pain, numbness, tingling down left arm that started 10 minutes later, weakness in left 4th and 5th fingers that is still present. Tx: Ibuprofen (OTC), cold locally.									N	10/10/2005	10/10/2005	0	NONE	PVT	PVT	Synthroid	NONE	Hashimotos Thyroiditis s/p partial thyroidectomy, MVP asymptomatic (12 yrs ago).			1						1	Asthenia; Feeling cold; Hypoaesthesia; Injection site pain; Paraesthesia	FLU3~EVANS VACCINES~U1762AA~2~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0245649	10/19/2005	IL	60.0	60		F	10/12/2005	C/o severe sore arm with warmth, redness and swelling. After receiving pneumonia vaccine. Had previous pneumonia vaccine 9/29/99.				Y					Y	10/05/2005	10/05/2005	0		PUB	UNK				10/05/2005~Pneumo (no brand name)~2~0.00~In Patient		1						1	Feeling hot; Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U1803AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0790P~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245650	10/19/2005	NV	72.0	71		M	10/11/2005	Immediately following shot pain in arm, couple of hrs later swelling and redness. Following day, red swollen upper arm went to ER placed on antibiotics				Y					Y	10/10/2005	10/10/2005	0		UNK	UNK	NONE	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U1771AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~07914~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245651	10/19/2005	NV	67.0	66		M	10/11/2005	Immediately following shot pain in arm. Couple of hours later swelling and redness. Following day, Red swollen upper arm, went to ER, placed on antibiotics.				Y					Y	10/10/2005	10/10/2005	0		UNK	UNK	NONE	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U1771AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~07914~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245652	10/19/2005	IA	37.0	37		F	10/12/2005	Fever, aches, took ibuprofen symptoms better in 48 hrs.									Y	10/10/2005	10/10/2005	0		PVT	PUB		NONE	NONE			1						1	Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1803AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245653	10/19/2005	AZ	54.0	54		F	10/12/2005	Two hours after flu vaccine administered experienced headache, extreme fatigue, wheezy cough, dizziness, loss of balance. Next (AM) fatigue, nausea, dizziness, slight loss of balance.									Y	10/11/2005	10/11/2005	0	NONE	PUB	OTH	Vytorin, Prozac, ASA 81mg	NONE	High cholesterol, depression			1						1	Cough; Dizziness; Fatigue; Gait disturbance; Headache; Nausea; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0245654	10/19/2005	WV	1.35	1	.3	F	10/10/2005	After receiving vaccines, pt developed 4.5 inch red, warm to touch, tender area on left thigh. On 10/7/05 she was diagnosed with cellulitis and started on an antibiotic.				Y					U	10/05/2005	10/07/2005	2	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Cellulitis; Feeling hot; Injection site erythema; Tenderness	DTAP~SANOFI PASTEUR~U1342BC~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1792AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0184R~4~IM~RL~HIB (PEDVAXHIB)~1	USA	Emergency room visit	Influenza
0245655	10/19/2005	PA	0.84	0	.8	F	10/12/2005	10:30PM woke up with fever 103.7 R, Grabbing head vomiting and had non-stop crying from 10:30PM to 5:00AM. Seen in Dr's office on 10/11/2005 at 3:30PM. No reaction noted at injection site. No ear infection Dx.				Y					Y	10/10/2005	10/10/2005	0	NONE	PVT	PVT	Fluoride qd, Motrin prn, Tylenol prn.	Temp 100.7 R, fussy, rubbing eyes	RAD			1						1	Crying; Headache; Pyrexia; Screaming; Vomiting	FLU3~SANOFI PASTEUR~U1743HA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245656	10/19/2005	CO		4		M	10/12/2005	17cm x 15.5cm area of erythema and induration with min. tenderness, no fever.									Y	10/10/2005				PVT	PVT						1						1	Injection site erythema; Injection site mass; Tenderness	FLU3~SANOFI PASTEUR~U1773AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245657	10/19/2005	GA	6.0	6		M	10/12/2005	Large local reaction 9x8 left arm red.				Y					Y	10/10/2005	10/11/2005	1		PVT	PVT						1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U1746AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245658	10/19/2005	CA	0.62	0	.6	F		Urticaria 1 hr after influenza vaccine.				Y					Y	10/10/2005	10/10/2005	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1743GA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245659	10/19/2005	NY	91.0	91		F	10/19/2005	IM Flu vaccine (lot#AFLUA120AA) given on 10/10/2005. Between 10/11 to 10/13 the patient experienced nausea and vomiting. On 10/13 the patient experienced coffee-ground emesis. On 10/14 the patient expired. Cause of death pending medical examiner report.	Y	10/14/2005							N	10/10/2005	10/11/2005	1	Recent potassium 6.5 - hemolyzed (date not indicated)	UNK	UNK	Celexa 40mg daily, Senna 2 tabs qHS, Losartan 100mg daily, amlodipine 10mg daily, colchicine 0.6mg daily, Miacalcin, aspirin 325mg daily, sinemet 25/100 TID, prednisone 5mg daily, meclizine.		Penicillin allergy			1						1	Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~AFLUA120AA~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0245661	10/19/2005	NY	50.0	50		M	10/19/2005	EMPLOYEE RECEIVED FLUZONE VACCINE 0.5 ML AT APPROX 12PM. AT APPROX 4 PM DEVELOPED WHEEZE, COUGH, EYE IRRITATION. SEEN IN ED, RECEIVED NEBULIZER TREATMENT AND RX FOR MEDROL DOSE PACK.				Y					Y	10/14/2005	10/14/2005	0	NONE	UNK	UNK			SYNTHROID TOPROL XL FLECAINIDE			1						1	Cough; Eye irritation; Wheezing	FLU3~SANOFI PASTEUR~U1753AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245662	10/19/2005	WI	36.0	36		M	10/19/2005	Flumist administered 10/12 half of dose in each nostril - 2nd nostril some swallowed by pt. Upper respiratory infection started 10/14 - mild rhinitis/congestion.  Early AM Tues 10/18 at 0100 nausea & vomiting q 1hr till 0600.									Y	10/12/2005	10/18/2005	6		UNK	UNK	None	None	None			1						1	Nasal congestion; Nausea; Rhinitis; Upper respiratory tract infection; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0245663	10/19/2005	TX	55.0	55		F	10/19/2005	Patient's symptoms began 24 hrs after administration of Pneumovax in the right deltoid. Patient had swelling and hives at the site of injection and moved upward to the top of the arm. Also had swelling in the lymph nodes in the right armpit area. Patient applied ice and took Benadryl for 2 days. Symptoms subsided.									Y	10/15/2005	10/16/2005	1	None	UNK	UNK	Cozaar 50mg, Femhrt 1/5	None	Hypertension			1						1	Injection site swelling; Lymphadenopathy; Urticaria	FLU3~SANOFI PASTEUR~U1806AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0748P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245670	10/19/2005	IL	40.0	40		M	10/19/2005	Loss of use of arm due to extreme shoulder pain. Nausea and dizziness. No swelling or redness at site.  Worst symptom happens onboard a flight. Nausea and siziness left prior to landing. Pain remained.				Y					Y	10/17/2005	10/17/2005	0	ER doctor checked shoulder for signs of joint damage, and found none.	UNK	UNK	Synthroid, Lithium Carbonate, serevent, Singulair, Lipitor.	None	Allergies: PCN, Mold, Trees. BiPolar, Hypothyroidism, Small Fiber Neuropathy leading to Chronic Ideopathic Anhydrosis with Dysthesia/Parathesia.			1						1	Dizziness; Nausea; Shoulder pain	FLU3~SANOFI PASTEUR~~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245672	10/19/2005	NC	3.0	3		M	10/14/2005	Moderate swelling, pain and redness right thigh, unsure of fever.									U	10/12/2004	10/13/2004	1		PUB	PUB		cough, fever				1						1	Hypersensitivity; Oedema; Pain	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC148002AA~5~IM~~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1746AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0264~4~IM~~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0609P~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0245673	10/19/2005	WA	73.0	73		F	10/07/2005	Swelling and pain left upper arm.									Y	10/06/2005	10/06/2005	0		PVT	PVT						1						1	Oedema; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA131BA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0792P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245674	10/19/2005	WA	32.0	31		F	10/17/2005	Burning initially then, red hot raised circle about 1 1/2 from injection for 3 days. Now muscle pain in arm when extending out.									Y	10/11/2005	10/11/2005	0		PVT	PVT	Zoloft, Prenatal vitamins					1						1	Injection site hypersensitivity; Injection site swelling; Injection site warmth; Myalgia; Skin burning sensation	FLU3~SANOFI PASTEUR~U1818AB~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245675	10/19/2005	TX	3.0	2	.7	F	10/06/2005	Left thigh swollen and tender. She would not support her weight on it.				Y					Y	10/05/2005	10/06/2005	1		PVT	PVT	PPD	NONE	NONE			1						1	Hypokinesia; Oedema; Tenderness	FLU3~SANOFI PASTEUR~U1754AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0287R~1~~LL~HEP A (VAQTA)~1|PNC~PFIZER\WYETH~B08634E~4~~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0245676	10/19/2005	TX	4.0	3		M	10/06/2005	Isolated redness of nose, mouth, and inner ear, nose running, 10ml Benadryl given PO 3:30pm. No difficulty breathing, no swelling of mouth or tongue.				Y						10/06/2005	10/06/2005	0		PUB	PUB		NONE	Cerebral Palsy		TX05087	1						1	Hypersensitivity; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1761AA~UNK~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245678	10/19/2005	VT	2.0	2	.2	M	10/18/2005	NONE									U	10/18/2005				PVT	PVT		NONE	NONE			1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA126BC~1~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0245679	10/19/2005	OH	50.0	49		F	10/19/2005	10/18/2005 C?O flushing at home in evening, 10/19/2005 generalized erythematous rash with pruritus scattered over arms, legs, torso. Lungs - no difficulty Resp, Treatment Benadryl, Hydrocortisone cream.				Y					U	10/18/2005	10/19/2005	1		PVT	PVT	BP med, Tramadol.		egg allergy			1						1	Flushing; Pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~U1773AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245680	10/19/2005	TN	24.0	24		F	10/19/2005	Worked all night, vaccinated at 8:15, went to bed at 8:30. Woke at 11 am, ,body sore, chilling, weakness, (unable to pick up 20 lb child). excruciation headache, Temp 101, symptoms still present at 24 hours past immunization.									Y	10/18/2005	10/18/2005	0		PUB	OTH		NONE				1						1	Asthenia; Feeling cold; Headache; Hypokinesia; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA138BA~1~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0245681	10/19/2005	MO	55.0	55		F	10/19/2005	On Friday, Oct 14 2005 employee contacted employee health nurse and related on 10/12/2005 she had discomfort, swelling and redness at injection site which she reported has continued. Advised to be evaluated in on site ER. 10/14/2005 Diagnosis is cellulitis of vaccine injection site. RX Keflex 500 mg QID 28, Ibuprofen for pain, swelling, warm moist packs to site. Employee was afebrile and denied body aches. Monday 10/17/2005 F/U in Employee Health physicians office, C/O throbbing at injection site, chilling, aching and nauseated. Afebrile. Continued Keflex and ibuprofen. Rx for Benadryl 25mg PO Q 6 hours as needed for itching at injection site.				Y					Y	10/11/2005	10/12/2005	1	NONE	PUB	PVT						1						1	Cellulitis; Chills; Discomfort; Injection site hypersensitivity; Injection site oedema; Injection site pain; Nausea; Pain; Pruritus	FLU3~SANOFI PASTEUR~U1761AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245775	10/19/2005	WI	51.0	51		M	10/19/2005	Angioedema of face/head the morning after receiving vaccine									Y	10/12/2005	10/13/2005	1	NONE	PVT	OTH	Capodicin cream, Allegra, Albuterol	NONE	ASA severe, Theophylline, Nsaids, Vicodin, Biaxin			1						1	Angioneurotic oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~131AA~5~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0245732	10/20/2005	CA	31.0	31		F	10/19/2005	Initial report received from a healthcare provider on 10/14/05. A 31 year old female patient with no pre-existing medical history received an injection of Fluzone SV 2005-2006 USP, lot number unknown, on 10/14/05. Route and site of administration was not reported, and number of previous doses was unknown. She immediately, felt faint, hot and sweaty, and her throat felt swollen. She was seen by a physician, but treatment was not reported. The patient denied illness at the time of vaccination and was on no medications. At the time of this report, the patient had recovered. (OMIC)				Y					Y	10/14/2005	10/14/2005	0		PVT	PVT			The patient denied illness at the time of vaccination, has no pre-existing medical conditions, and was not on other medications. She also had no known allergies.		200502114	1						1	Feeling hot; Hyperhidrosis; Pharyngeal oedema; Syncope	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245733	10/20/2005	MI	50.0	50		F	10/19/2005	Initial report received from a patient who is a health care provider on Oct 14 2005. A 50 year old female patient with no pre existing medical history received in the left deltoid, an injection of Fluzone no preservation 2005 2006, lot number U1752LA, on Oct 13 2005. Within one hour, she experienced a feeling that something was stuck in her throat, a stinging sensation in her mouth and puffy and itchy eyes. She also complained of headache. The patient indicated this was her first vaccination with flu vaccine. The patient has no known allergies and takes vitamins and calcium. Illness at the time of vaccination was not specified. The next morning she was feeling better but the puffy and itchy eyes persisted. She took Claritin that am. Per the reporter, the patient was not evaluated by a physician. At the time of this report, the patient had not recovered.				Y					N	10/13/2005	10/13/2005	0	Relevant diagnostic laboratory test were not reported.	PVT	PVT	Calcium, Vitamins		There are no pre existing medical conditions and no known allergies. The patient takes vitamins and calcium.		200502097	1						1	Eye swelling; Headache; Pain; Pruritus; Stomatitis; Throat tightness	FLU3~SANOFI PASTEUR~U1752LA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245734	10/20/2005	NJ	51.0	51		F	10/19/2005	Initial report received from the pt on 12Oct05. A 51 yr old female pt had received an injection of Fluzone, no preservative 2005-2006, lot number U1752LA, route/site not reported on 29Sep05. On the day of vaccination, the pt experienced shortness of breath, weakness and numbness in her head. Per the reporter, it won't go away. The pt denied illness at the time of vaccination. She would not reveal information regarding pre-existing medical conditions or use of other medications at the time the time of vaccination. At the time of this report, the pt had not recovered from these events and is being evaluated by her own physician next week.				Y					N	09/29/2005	09/29/2005	0	There were no relevant diagnostic or lab tests reported.	UNK	UNK			The pt denied any illness at the time of the vaccination. The pt would not reveal information regarding pre-existing medical conditions or use of other medications at the time of the vaccination.		200502083	1						1	Asthenia; Dyspnoea; Hypoaesthesia	FLU3~SANOFI PASTEUR~U1752LA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245751	10/20/2005	TX	1.11	1	.1	F	10/20/2005	Patient, who is 20 months old, developed shingles seven months after receiving vaccination.									U	03/30/2005	10/14/2005	198	None	UNK	UNK	none	None	Allergy to penicillin.			1						1	Herpes zoster	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|HEP~UNKNOWN MANUFACTURER~~3~~UN~HEP B (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0245752	10/20/2005	CO	74.0	74		F	10/20/2005	on 10/05/05 Pt experience redness swelling at site and the red streaking upwards. This was on left deltoid.  She describes violent pain into her muscles and joints.  The joints involved are elbows, wrists, hands, hips and knees.  Pt has had difficulty sleeping.  She came in on 10/18/05 and had not let her provider know of her problem.									U	10/03/2005	10/05/2005	2	Discussed with doctor.  also infectious ds doctor.  CBC and sed rate on 10/18/05- normal. Treated with medrol dose pack and feeling better 10/20/05.	UNK	UNK	triamterene/HCTZ- stopped since having reaction	no	Edema, hypothyroidism, anxiety/depression.			1						1	Arthralgia; Injection site erythema; Injection site swelling; Insomnia; Myalgia; Skin striae	FLU3~PFIZER\WYETH~U1745AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|TD~AVENTIS PASTEUR~U1618AA~2~IM~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0245754	10/20/2005	GA	64.0			M	10/20/2005	Noticed at approx. 7pm that his right shoulder and arm were swollen, red and warm. Had pain in the shoulder joint. Right hand swollen. had some nausea. Went to ER at about 3 am and was given a pain shot and sent home a couple of hrs. later.				Y										UNK	UNK	Antacids, Hizar (BP med)	no	no allergies			1						1	Arthralgia; Erythema; Feeling hot; Nausea; Oedema peripheral; Swelling	FLU3~SANOFI PASTEUR~U1762AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245756	10/20/2005	NY	66.0	65		M	10/20/2005	Approximately 4 hours after recieving vaccine the patient developed pain, swelling and warmth of his right arm.  Patient states he had fever at this time but did not measure it.  On 10/14/05, patient visited his PMD.  Dr. diagnosed cellulitis and prescribed ciprofloxacin and warm compresses.  Patient states he has had had pneumococcal vaccine previously, most recently approximately 3 years ago.  Dr. reviewed patients chart and stated he has never given the patient pneumococcal vaccine.				Y					U	10/13/2005	10/13/2005	0	None	UNK	UNK		None	History of Splenectomy			1						1	Cellulitis; Injection site pain; Injection site reaction; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1819AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0887P~2~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245759	10/20/2005	MA	55.0	54		F	10/20/2005	10/4/05 Influenza Vaccine given. 10/5 Local reaction at site pink and warm. 10/6 Local reaction about 4x5 arm was tender, red, hard and warm at site of injection. Ice was applied several times to the area. Went to see her NP. The NP advised her to take Benadryl by mouth and to apply ice. The NP advised her to tell RN to fill out a report and to consider giving a smaller dose of flu vaccine next year. RN advised her to get more information about the flu vaccine dosage or have her provider give the dosage next year. She said she has taken antibiotics for past localized reaction to flu vaccine in past years. 10/10 Site of injection much improved as reported.				Y					Y	10/04/2005	10/05/2005	1	none	UNK	UNK		Mild respiratory condition	Diabetes Type 1, GERD, Irrit. Bowel	Local reactions~Influenza (Seasonal) (Fluzone)~~0.00~In Patient		1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~Ui777AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245760	10/20/2005	LA	27.0	27		F	10/20/2005	Localized reaction to injection site.  Measured 40 X 45 mm raised, reddened, and warm to the touch.  No other symptoms.									U	10/19/2005	10/19/2005	0		UNK	UNK		None				1						1	Injection site erythema; Injection site reaction; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1756AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245762	10/20/2005	MA	80.0	80		M	10/20/2005	10/19/2005 Fluarix given to the patient. Patient reported on 10/20 that he started with severe abdominal cramps and nausea four hours after receiving the injection. C/0 severe abd cramps all night and woke at 4am with pain and around projectile vomiting and diarrhea for 15 minutes. No blood noted in fluids. Patient and wife ate the same food and she was not ill. However she did have the same type flu shot with no ill effects. At 4pm on 10/20 patient had diarrhea once again no vomiting.									U	10/19/2005	10/19/2005	0		UNK	UNK	Megace, Coumadin 4mg or 5mg qod, Pravachol 40mg daily, Megace 20mg daily	none	NKA prostate cancer, bone metastastis			1						1	Abdominal pain; Diarrhoea; Nausea; Vomiting projectile	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU141BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0245763	10/20/2005	OK	44.0	43		F	10/20/2005	The shot was administered about 2:00pm.  I was feeling fine, around 4:00pm I started coughing, throat began to tighten & become sore.  Began to have a weakening in the chest.  I took a tylenol & laid down.  After about 15-30 min I woke up & my lower lip, & around my chin were swollen.  My left arm (where the shot was given was really sore).  I began to feel weak all over.  My eyes became runny & very red, the numbness in my lower lip began to spread to my upper lip & I could feel tingling moving up my face.  I went to the Urgent Care & when the doctor felt around the top of my neck just below my bottom lip was tender.  My nose was runny, & I was coughing up some.  I threw up 3 times & was very nauseous.  I don't know if that was due to the shot the doctor gave me--I didn't become nauseous until after the shot.				Y					Y	10/19/2005	10/19/2005	0		UNK	UNK	Levoxyl	Non				1						1	Cough; Eye discharge; Face oedema; Hypoaesthesia; Nausea; Ocular hyperaemia; Paraesthesia; Pharyngolaryngeal pain; Rhinorrhoea; Throat tightness	FLUX~SANOFI PASTEUR~U1831AB~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0245765	10/20/2005	NV	60.0	59		M	10/20/2005	Developed swelling, erythema and heat at vaccine administration site right arm. Edema to elbow. Diagnosed with Cellulitis and given IV antibiotic and treated with Levoquin p.o.				Y					U	10/18/2005	10/18/2005	0		UNK	UNK			hypertension;asthma			1						1	Cellulitis; Injection site erythema; Injection site reaction; Injection site swelling; Injection site warmth; Joint swelling	FLU3~SANOFI PASTEUR~u1836aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0967p~UNK~IM~RL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245766	10/20/2005	OR	76.0	75		F	10/20/2005	lower back pain									N	10/11/2005	10/12/2005	1		UNK	UNK						1						1	Back pain	FLU3~SANOFI PASTEUR~U1805AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245767	10/20/2005	OR	76.0	76		M	10/20/2005	lower back pain									N	10/13/2005	10/14/2005	1		UNK	UNK	Lipitor 20 mg, HCTZ 25 mg, Atenolol 25 mg					1						1	Back pain	FLU3~SANOFI PASTEUR~U1805AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245769	10/20/2005	CA	54.0	54		F	10/20/2005	Within 12 hours, severe pain at injection site, weakness, headache, body aches, fever of 102.9 (at midnight), fever was reduced to 101.9 and remained there for the next 10 hours, then dropped to 97.6 and elevated again to 100.9, remaining there throughout the day. treated with bed rest, cold compresses on head, neck, wrists, acetaminophen, and liquids.									U	10/19/2005	10/19/2005	0	none	UNK	UNK	Excedrin Migraine Rhinocort aqua		fibromyalgia			1						1	Asthenia; Headache; Injection site pain; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245771	10/20/2005	NY	46.0	45		M	10/20/2005	After receiving flu vaccine pt became vasovagal. Placed in chair, head to knees, water tolerated PO. Became diaphoretic, pale, O2 non rebreather applied, LOC approx 5 sec, EMS called, B/P taken, pulse taken, fingerstick done. Removed from health unit by EMS, stable v/s wnl per EMS.				Y					Y	10/20/2005	10/20/2005	0		OTH	OTH	UNK	NONE	NONE			1						1	Dyspnoea; Hyperhidrosis; Hypoxia; Loss of consciousness; Pallor; Syncope vasovagal	FLU3~SANOFI PASTEUR~U1764AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245772	10/20/2005	IL	1.5	1	.5	M	10/20/2005	Swelling of 1/2 left upper arm. Pink and warm to touch. Tender at injection site. Reported by mother to Dr 30 hrs after injection. Advised cool compresses to affected area. Seen in office 10/19/05. Advised to continue same.									Y	10/17/2005	10/18/2005	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Feeling hot; Injection site erythema; Injection site oedema; Tenderness	DTAP~SANOFI PASTEUR~C2254AA~4~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1743KA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~0496~3~SC~LA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0245773	10/20/2005	CA	46.0	46		F	10/20/2005	Approx 6 hrs after flu shot, developed chills, body aches, headaches, fatigue which lasted throughout the noc. Itching of non well being (hives). 4AM to 10AM on 10/12/05. Symptoms lasted approx 2 days but still has small raised area mildly in left arm and chest. Took Tylenol on 10/11/05 1000mg at 16:30 then 500mg 3 hrs later.									Y	10/11/2005	10/11/2005	0		PUB	UNK	Novolen insulin 70/30, Glucophage	NONE	Diabetes Mellitus type II, Allergic to ASA and PCN		CA050072	1						1	Chills; Fatigue; Headache; Injection site swelling; Myalgia; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1828AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245774	10/20/2005	TX	82.0	82		F	10/18/2005	Severe bruising approx 2 inch in diameter; pt states no heat or redness, does not hurt arm with pressure.									Y	10/15/2005	10/15/2005	0		OTH	OTH	Premarin, Synthroid, Zoloft, Sectral, Detrol LA	NONE	Food Allergies			1						1	Contusion	FLU3~SANOFI PASTEUR~U1806AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245776	10/20/2005	GA	72.0	72		F	10/13/2005	Rash below site 4x3 approx 2 days later, left arm slightly below deltoid.									Y	10/11/2005	10/13/2005	2		OTH	OTH	Lisinopril 20mg		NONE			1						1	Injection site rash	FLU3~SANOFI PASTEUR~U1747AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749p~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245777	10/20/2005	TX	70.0	70		F	10/15/2005	Within 2 hrs, arm swelled and ached. Next day arm very swollen, hot and blood red, very painful. Third day same and visited my Dr. He told me I had a severe allergic reaction and recommended my never it again. It took 5 days for it all to disappeared and allow me to sleep pain free.									Y	10/11/2005	10/11/2005	0	Severe allergy reaction	OTH	PVT	Advair, Albuterol	COPD	COPD	Flu~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Erythema; Feeling hot; Hypersensitivity; Injection site oedema; Injection site pain; Myalgia	FLU3~SANOFI PASTEUR~49281037615~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~00006473900~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245778	10/20/2005	DC	1.84	1	.8	F	10/14/2005	About 24 hrs after influenza vaccine given, pt reported to have cluster of suspected seizures (shaking right leg then other extremities, stiffening turning head to right, unresponsive for 10-15 minutes later sleepy. While at day care. Sleepy.  Normal exam when seen that afternoon.				Y					Y	10/10/2005	10/11/2005	1	Negative brain CT	PVT	UNK	NONE	Runny nose, cough, day after vaccination	Trisomy 21, S/P a canal repair, PET placement.			1						1	Coma; Convulsion; Musculoskeletal stiffness; Somnolence; Tremor	FLU3~SANOFI PASTEUR~U1818AB~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245779	10/20/2005	AL	1.81	1	.8	M	10/14/2005	Febrile Seizure Medical records state fever, uncer of the mouth. msv				Y					Y	10/13/2005	10/13/2005	0	Medical records state increased WBCs. msv	PVT	PUB		Mom repots pt didn't feel well prior to immunization Medical records state viral infection. msv	Surgery for pyloric stenosis			1						1	Febrile convulsion; Mouth ulceration; Pyrexia; White blood cell count increased	FLU3~SANOFI PASTEUR~U1743NA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245780	10/20/2005	OH	66.0	65		F	10/15/2005	Extreme soreness in arm (hard to move), fever (101). Pt used ice and ibuprofen (called later and feeling much better).									Y	10/14/2005	10/15/2005	1		OTH	UNK						1						1	Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0791P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245781	10/20/2005	OH	68.0	67		M	10/15/2005	Extreme soreness in arm (has to lift it with other arm). Pt used ice and ibuprofen (called later and feeling much better).									Y	10/14/2005	10/15/2005	1		OTH	UNK						1						1	Hypokinesia; Injection site pain	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0791P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245782	10/20/2005	IL	65.0	65		M		Starting later afternoon (5PM) 10/10/05 pt experienced moderate to severe pain and some swelling at injection site. Was unable to bring his arm across his chest until 10/13/05. Moving arm up and down was painful also. As of 10/16/05 symptoms were gone except for some pain near injection site. Still some minor pain at injection site. Patient received pneumo vaccine (left arm) and fluzone vaccine (right arm) on the same day Oct 10,2005. There was no problem w/the flu shot; only in the arm (left arm) with the pneumo shot. The patient now is recovered fully.									Y	10/10/2005	10/10/2005	0		UNK	UNK						1						1	Hypokinesia; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~01806AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0605P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245783	10/20/2005	CO	76.0	76		F	10/17/2005	10/03/05 flu left arm and pneumonia right arm shots at drug store clinic. By supper time both arms were terribly sore. The pneumonia arm was warm and achy in addition. It throbbed and itched all night and all the following day. I had aches with pains all over by body and I was either burning hot or so cold I shook all night long. There was no sleep. The next day I slept a little from time to time and took pain meds (Esgic plus). Rubbed the itching arm with Solorcaine ointment, stayed in bed and suffered. My bowels were runny and I felt lousy. I had a dry cough and a runny nose. It was hard to lift the pneumonia arm until Thursday when it finally eased up. It really felt like I had some type of flu, I had never had a reaction from either type of shot previously. This is Friday and I still feel lousy, but I kept my chiropractic appt. It is not the 14th and am just beginning to feel like maybe I am getting well.										10/03/2005	10/03/2005	0	NONE	OTH	OTH	Estrace 6x weekly AM 1mg, Estratest 1x wkly AM 1/2 and 1/2, Armour Thyroid daily AM 65mg, Coumadin 6x wkly PM 5mg, Atenolol daily PM 50mg, Digitek daily AM 0.25mg, VagiFem Inserts 1 in approx 10 days, Esgic Plus as needed occasional, Lorata	NONE	Pacer, Atrial fib, heart problems managed well by doctor.			1						1	Diarrhoea; Feeling hot; Hypokinesia; Influenza like illness; Injection site pain; Myalgia; Pruritus; Rhinorrhoea; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~01811AA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~0192P~2~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0245784	10/20/2005	VT	4.0	3		M	10/18/2005	Had flu shot; c/o severe pain later that eve 10/12. When awoke 10/14 has 5-6cm sharply demarcated erythema with 2cm induration in center, very hot and tender. Rx with Duricef x 7 days.				Y					Y	10/12/2005	10/14/2005	2	NONE	PVT	PUB	On Zithromax for persistent otitis media.	R A OM	Amoxicillin rash 10/12/05, asthma.			1						1	Feeling hot; Injection site erythema; Injection site mass; Injection site pain; Tenderness	FLU3~SANOFI PASTEUR~U1804AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245785	10/20/2005	GA	77.0	77		F		Developed rash over entire body about 1 hr after vaccine with edema of lips, chin and ears. Treated at MD office with IV Benadryl was released after 3 hours on prednisone and Zantex at present. Client had allergic reaction to Nexum, had been clear of rash x 2days did not inform nurses of Nexum allergy.				Y					Y	10/12/2005	10/12/2005	0		PUB	PUB						1						1	Oedema; Rash	FLU3~SANOFI PASTEUR~U1836AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245786	10/20/2005	AR	5.0	5		M	10/06/2005	Cough and Nasal congestion. MEDI-0003727 is a non serious spontaneous case from a consumer in the USA involving cough:(Labelled, USA, ). The reporter causality is not provided to FluMist. This case is submitted according to the VAERS Safety Surveillance accelerated reporting agreement for FluMist. A consumer reported that her 5 year old son experienced cough and nasal congestion 4 days after receiving FluMist vaccine on 28Sep05.  The patient has not yet recovered at this time. Earlier, the reporter called in an adverse event report involving her own symptoms after she received FluMist vaccine. The reporter causality is not provided.  Follow-up information received 01-18-2010. Lot number information obtained from reporter.									N	09/28/2005	10/02/2005	4	NI	OTH	OTH	Concomitant Drug(s) Not Reported		NI		MEDI0003727	1						1	Cough; Nasal congestion	FLUN3~MEDIMMUNE VACCINES, INC.~500386P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0245787	10/20/2005	TX	28.0	27		F	10/20/2005	Systemic hives, pruritus started approx 24 hours after injection.				Y					Y	10/19/2005	10/20/2005	1		PVT	PVT	Lexa pro, Yasmin, Kinopin	NONE	NONE			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1905AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245788	10/20/2005	CT	91.0	90		F	10/20/2005	At site of injection area became swollen immediately, ice pack applied swelling went down. Next day individual came area still swollen with ecchymotic areas at site of injection. I to call MD with any further concerns.									Y	10/18/2005	10/18/2005	0		PUB	PUB	HCTZ		HYPN			1						1	Injection site haemorrhage; Injection site oedema	FLU3~SANOFI PASTEUR~U1810AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245789	10/20/2005	WI	34.0	34		F	10/20/2005	Throat constriction over 3 hours, DX epinephrine, Solumedrol, prednisone 60 mg at home, 20mg TID.				Y					Y	10/18/2005	10/18/2005	0		PVT	PVT	NONE	NONE	NONE			1						1	Throat tightness	FLU3~SANOFI PASTEUR~U1861AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245790	10/20/2005	TX	2.0	2	.1	M	10/20/2005	Per mother stated he had a very slight rash face, neck on Monday after vaccines given. On Tuesday his left eye swollen up, pt itching. But I did not call on Tuesday. Rash is worse today (Wednesday). Rash to right upper arm, face, neck. Mother was advised to bring pt into clinic to be assessed. Pt assessed by APRN.				Y					Y	10/17/2005	10/19/2005	2	NONE	PVT	PUB	Tylenol as needed given per mother.	NONE	Phenergan, PCN, Augmentin ES, Diagnosed with roseola.	rash~Measles + Mumps + Rubella (no brand name)~0~1.00~In Patient		1						1	Eye oedema; Pruritus; Rash	DTAP~SANOFI PASTEUR~U1349CA~5~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1805AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1091P~1~IM~RL~HEP A (VAQTA)~1|PNC~PFIZER\WYETH~A94456A~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1113P~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0245792	10/20/2005	PA	82.0	81		M	10/17/2005	Pt states one hour after the shot, my arm started itching. Then it started getting red and swelling. It hurts when I use my arm. Keflex and Benadryl.				Y					Y	10/14/2005	10/14/2005	0		OTH	OTH		NONE	Morphine, hypertension, HL, Coronary artery disease.			1						1	Hypersensitivity; Oedema; Pain; Pruritus	FLU3~SANOFI PASTEUR~U1810AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245793	10/20/2005	CA	37.0	36		F	10/20/2005	Rash at injection site within 12 hours of administration. Non Pruritic. 1-2 mm papular skin cover to numerous to count right deltoid, shoulder, right side face.										10/06/2005	10/06/2005	0		PUB	OTH	Erythromycin	Sinusitis				1						1	Rash papular	FLU3~SANOFI PASTEUR~U1B32BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245794	10/20/2005	TX	6.0	6		M	10/20/2005	Redness, heat, induration starting at injection site and spreading over entire thigh over 2-3 days.				Y					Y	10/17/2005	10/18/2005	1		OTH	OTH		NONE	Hydrocephalus, Developmental Delay			1						1	Injection site hypersensitivity; Injection site induration; Injection site warmth	FLU3~AVENTIS PASTEUR~U1836AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245799	10/20/2005	WA	66.0	66		F	10/20/2005	Right arm discomfort, weakness armpit side not deltoid.									U	10/18/2005	10/19/2005	1		UNK	UNK						1						1	Asthenia; Discomfort	FLU3~SANOFI PASTEUR~U1903AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245453	10/21/2005	CA	43.0	42		F	10/20/2005	Initial report received from health care provider on 13Oct05. A 42 year old female with medical history not reported received an IM injection in the left deltoid of Fluzone SV 2005-2006, lot number U1803AA on 12Oct05 at 12:00PM. Five hours later, she developed an itchy throat, shortness of breath and chest tightness. She was seen in the ER and treated with Benadryl 50mg IM. Relevant diagnostic tests were reported as none. Her symptoms resolved, and she was discharged from the ER. She had no illness at the time of vaccination and was on no medications. At the time of this report, she had recovered. The reporter for this case is the same as for cases 200502110, 200502101 and 200502111.				Y					Y	10/12/2005	10/12/2005	0	Relevant diagnostic/lab tests were reported as none.	PUB	UNK			Pre-existing medical history was not reported. The pt had no illness at the time of vaccination and was on no medications.		200502095	1						2	Chest discomfort; Dyspnoea; Pruritus; Chest discomfort; Dyspnoea; Pharyngolaryngeal pain; Pruritus	FLU3~SANOFI PASTEUR~U1803AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1803AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0245455	10/21/2005	CA	56.0	55		F	10/20/2005	A 55 year old female received an IM left deltoid injection of Fluzone SV 2005-2006 USP, lot number U1803AA, on 12Oct05 at 2:00PM. Four hrs later, she experienced tingling in her left arm and shoulder and leg. She also complained of general malaise. The pt had no shortness of breath, no weakness and no egg allergies. Illness at the time of vaccination was none. Pre-existing medical conditions were not reported. Information regarding other medications was unk. She was examined in an ER, and no treatments were given. There were no relevant diagnostic or lab tests. At the time of this report, the pt had recovered. The reporter of this case is the same reporter for cases 200502101, 200502111 and 200502095. (OMIC)				Y					Y	10/12/2005	10/12/2005	0	NONE	PUB	UNK			Preexisting medical conditions for the pt were not reported. There was no illness at the time of vaccination, and information regarding other medications was unk. Information regarding previous doses was not reported.		200502110	1						2	Malaise; Paraesthesia; Malaise; Paraesthesia	FLU3~SANOFI PASTEUR~U1803AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1803AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0245815	10/21/2005	PA	76.0	76		F	10/20/2005	Initial report received from the pt's daughter on 12Oct05. A 76-year-old female pt, with medical history of sarcoidosis, diabetes type II, hypothyroidism, C-DIF, high blood pressure and high cholesterol, had received a left deltoid injection of Fluzone (lot unk) on 06Oct05 around noon. By the evening of 07Oct05, the pt's arm was sore and she developed a lump at the injection site. During the evening, the pt's oxygen levels had decreased from 91/94 to 84-89. On 08Oct, she developed a slight temp of 99.8F, her oxygen levels were decreased from normal to 88-90, oxygen saturation levels were 55-60 ans she had increased cough. Pt was normally on 2.5 liters of oxygen, oxygen was increased to 4 liters over the next three days gradually. On 09Oct, pt's oxygen levels were 80-85. When the pt's daughter listened to her lungs, she heard gurgling. Pt's temp was 99.8F. Pt's normal dose of Lasix was increased from 40 to 60mg and Prednisone was increased from 12.5 to 20mg. Pt had slight improvement over the next day with oxygen levels at 90-93 and no gurgling present in lungs. On 10Oct, normal doses of Lasix and Prednisone were administered. Pt's temp was 98.8F. During the evening of 11Oct, pt had a temperature of 99.8F and her oxygen levels decreased to 88-90. 12Oct morning, she became winded trying to get out of bed, developed trouble breathing, gasping for air, her lips turned blue, her face was red, she had the chills, began shaking and coughing. Her oxygen levels were 55-60. Prevacid was given. A breathing treatment was given with no success of oxygen levels improving. Pt was admitted. For the symptoms, the pt received Benzonatate, Tylenol, Metronidazole and Macinex, pot chloride. Per the pt's daughter, the physician stated he felt the Fluzone vaccination caused the onset of the pt's symptoms because her immune level is low. She received concomitantly for medical conditions Caduet, Metoprolol, Lotrel, Amaryl, Levothyroxin and aspirin. Pt's recovery status: not reported. Follow-up received on 01-Nov-2005. As per the additional information, the patient had a past medical history of mediastinal lymphadenopathy, respiratory failure and depression. She has also past surgical history of hysterectomy, status post tracheostomy and cataract surgery. The lot number of the influenza vaccine administered is U1810AA. The patient hospitalised from 12-Oct-2005 to 23-Oct-2005 and she was readmitted again on 26-Oct-2005. Later, on 28-Oct-2005, she was transferred to another hospital for cardiac catherisation. The patient presented at medical center with the chief complaint of shortness of breath and acute exacerbation of an unspecified time. She was hypoxemic in the same morning at home. Oxygen saturation was in the range of 60 to 65. She has a history of sarcoidosis, congestive heart failure. She also had fever, chills or palpitations. She is also complaining of abdominal pain. She was evaluated in the emergency room, her Oxygen saturation on 100% non- rebreather mask was 92%. Her abdomen showed generalized tenderness. She was complaining of shortness of breath. Review of systems was significant for chief complaint of shortness of breath and abdominal pain. The patient denied other symptoms such as seizures, syncope, dizziness, blurry vision, chest pain, hemoptysis, nausea, vomiting, constipation, diarrhea, arthralgias, frequency, incontinence, fevers, chills or weight loss. Physical examination Showed the patient alert and oriented, in mild respiratory distress. She is sating 92% on 100% non-rebreather, pulse 118, respirations 32 per minute. Head and neck examination showed normocephalic, pupils are equal and react to light. Neck was supple. No Jugular venous distension, masses, goiter or carotid bruit. Heart: S1, S2, regular, no gallop or murmur. Lungs: Decreased breath sounds bilaterally with bilateral basilar rales. Abdomen: Soft, generalized tenderness, no evidence of any organomegaly. Extremities: no cyanosis, clubbing, edema. Central nervous system examination Showed no evidence of any focal neurological deficit. Chest x-ray showed evidence of bilateral lower lobe densities up to the lower halves of both the right and left hemithorax, which could be secondary to sarcoidosis, however overlying pneumonia can not be excluded. Review of the CBC of 12, hemoglobin of 13, hematocrit of 21, platelet count of 305, troponin was 0.05. According to the reporter, the impression was hypoxemia with respiratory failure, sarcoidosis, pneumonia, diabetes, hypertension but ruled out pulmonary edema, asthma and abdominal pain. She was also taking bentonite, ADVAIR, ATROVENT, calcium, vitamin D, prednisone 12.5 mg, LEXAPRO, metoprolol, LASIX and potassium. Outcome was not reported because the reporter was not sure whether the patient was recovered.					Y	12			U	10/06/2005	10/07/2005	1	10/12/05:blood gas, blood cultures, chest x-ray, EKG, CAT scan of stomach: results not provided.  Oxygen saturation was in the range of 60 to 65. He is sating 92% on 100% non-rebreather, pulse 118, respirations 32 per minute. Head/neck examination showed normocephalic, pupils are equal and react to light. Neck was supple. No Jugular venous distension, masses, goiter or carotid bruit. Heart: S1, S2, regular, no gallop or murmur. Lungs: Decreased breath sounds bilaterally with bilateral basilar rales. Abdomen: Soft, generalized tenderness, no evidence of any organomegaly. Extremities: no cyanosis, clubbing, edema. Central nervous system examination Showed no evidence of any focal neurological deficit. Chest x-ray showed evidence of bilateral lower lobe densities up to the lower halves of both the right and left hemithorax, which could be secondary to sarcoidosis, however overlying pneumonia can not be excluded. Review of the CBC of 12, hemoglobin of 13, hematocrit of 21, platelet count of 305, troponin was 0.05. CT of the chest was performed with intravenous contrast using PE protoc revealed no evidence of pulmonary embolism. The aorta is normal in calib without evidence of dissection. There is diffuse interlobular septal thickening, most severe in the lung associated with traction bronchiectasis and patchy mosaic ground-glass attention. This is consistent with pulmonary fibrosis.	PVT	PUB	Caduet 5mg, Metoprolol, Lotrel 5mg, Amaryl, Prednisone, Levothyroxin, baby aspirin, Lasix, Macinex DM, Oxygen. Bentonite; ADVAIR; ATROVENT;Calcium, Vitamtin D; COUMADIN; Prednisone; LEXAPRO; Metoprolol; Potassium	The pt had the following medical conditions: sarcoidosis, diabetes type II, hypothyroidism, high blood pressure, high cholesterol and C-DIF at time of vaccination.	The pt had the following medical conditions: sarcoidosis, diabetes type II, hypothyroidism, high blood pressure, high cholesterol and C-dif at time of vaccination. Mediastinal lymphadenopathy, respiratory failure and depression. Hysterectomy, status post tracheostomy and cataract surgery. Multiple admission in the past for COPD exacerbation/sarcoidosis and pneumonia. Allergies to Sulfa, penicillin and ACE inhibitors. Ex-cigarette smoker, denies alcohol abuse		200502070	1						1	Abdominal pain; Blood culture; Blood gases; Breath sounds abnormal; Bronchiectasis; Chest X-ray; Chest X-ray abnormal; Chills; Computerised tomogram; Computerised tomogram abnormal; Cough; Cyanosis; Dyspnoea; Dyspnoea; Electrocardiogram; Erythema; Erythema; Fluid retention; Full blood count; Haematocrit decreased; Haemoglobin; Haemoglobin normal; Hypoxia; Hypoxia; Injection site mass; Injection site pain; Lung disorder; Lung disorder; Oxygen saturation decreased; Platelet count normal; Pyrexia; Pyrexia; Rales; Respiratory distress; Tremor; Troponin; White blood cell count increased	FLU3~SANOFI PASTEUR~U1810AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0245827	10/21/2005	SC				U	10/18/2005	Flu shots and pneumonia shots were given to patients in our facility on 10/12/2005 By employees. Approximately 50 injections were given, Four of my employees had the typical reaction to a flu shot, soreness, swelling, redness, and heat at the injection site. On employees reaction was worse than the others. Two other patients reported a bad reaction, with one seeking medical attention at the physicians office next door. She had received the pneumonia shot in the affected arm, and she had severe inflammation and redness. the physician states that the injections were not given in the deltoid muscle of any of the patients that he saw. The shots were given much lower in the fatty tissue of the arm, and the physician was concerned that one patient may develop cellulitis because of the error. Representatives were contacted on 10/14/2005, and they told the physician that the administration technique problem had been addressed with the nurse, and that they had not received any other complaints concerning this particular lot number of the drug.										10/12/2005	10/12/2005	0		UNK	UNK						1						1	Inflammation; Injection site hypersensitivity; Injection site oedema; Injection site pain; Injection site warmth; Medication error	FLUX~UNKNOWN MANUFACTURER~U177AA~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0245828	10/21/2005	NM	74.0	73		F	10/18/2005	9.5 x 9cm edematous area on left upper arm where Pneumovax and flu vaccine were given the night before. Pink ring around edematous area. Has had flu vaccine before without any adverse reaction per patient.										10/17/2005	10/18/2005	1		UNK	UNK						1						1	Injection site hypersensitivity; Injection site oedema	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~UNK~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245829	10/21/2005	MI	1.63	1	.6	F	10/14/2005	Developed facial rash with periorbital redness, bilaterally and mild left sided periorbital edema, developed within 24 hours after vaccination. Also developed perineal rash likely from candida.										10/10/2005	10/11/2005	1		PVT	PUB		NONE	NONE			1						1	Bacterial infection; Hypersensitivity; Oedema; Rash	FLU3~SANOFI PASTEUR~U1743JA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0184R~4~~~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~A67182K~UNK~~~PNEUMO (PREVNAR)~1	USA		Influenza
0245830	10/21/2005	MD	72.0	71		M	10/18/2005	Right arm increased edematous, moving around arm, right arm reddened and painful, c/o limited motion. Referred to PMD.				Y					Y	10/15/2005	10/16/2005	1		PUB	PVT						1						1	Hypersensitivity; Hypokinesia; Joint range of motion decreased; Oedema; Pain	FLU3~SANOFI PASTEUR~U183JAA`~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0790F~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245831	10/21/2005	PA		81		M		Developed pain, swelling right shoulder evening after injection. 2 days later, could not lift right arm. Presented to PCP on 10/17/2005 with right shoulder bursitis and torticollis.									Y	10/09/2005	10/10/2005	1	NONE	OTH	PUB	Vitamins	NONE	NONE			1						1	Bursitis; Hypokinesia; Oedema; Pain; Torticollis	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~UNK~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245832	10/21/2005	CA	19.0	18		F	10/17/2005	Local erythema, indurated injection site right deltoid about 7 x 7 cm induration and erythema, warm to touch. C/O fever, fatigue.									U	10/14/2005	10/15/2005	1		OTH	PVT	NONE	NONE	History of pneumonia 02/05			1						1	Fatigue; Feeling hot; Injection site erythema; Injection site induration; Pyrexia	FLU3~SANOFI PASTEUR~U1754AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0704P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245851	10/21/2005	NJ	47.0	47		F	10/21/2005	Itchy throat followed by nausea and headache, followed by vomiting with hematemesis.									Y	10/19/2005	10/19/2005	0	none	UNK	UNK	none	none	none			1						1	Dry throat; Haematemesis; Headache; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U1743HA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245852	10/21/2005	NC	36.0	36		F	10/21/2005	Redness, swelling, and pain in left arm. Also, severe headache and fever. Inforrmation received from Discharge summary states Phlebitis, chest pain, post vaccine syndrome and injection site pain. msv					Y	1			Y	10/17/2005	10/18/2005	1	Medical records state anemia, hyperglycemia, increased sed rate.	UNK	UNK	Albuterol as directed PRN Flovent 2 puffs bid prn Serevent 2 puffs bid prn Zoloft 100 mg as directed Advair diskus 250 /50 as directed Allegra- D bid Singulair 10 mg qd Zoloft 50 mg qhs Maxzide 75/ 50 qd	Diagnosis: Upper Resporatory Infection, lumbago	Medical Conditions: Asthma GERD TMJ Bronchial asthma  Allergies: Darvocet Darvon Demerol Septra Erythromycin Discharge summary states migraine hx. msv			1						1	Anaemia; Chest pain; Erythema; Headache; Hyperglycaemia; Injection site pain; Pain; Phlebitis; Pyrexia; Red blood cell sedimentation rate increased; Swelling; Vaccination complication	FLU3~SANOFI PASTEUR~U1810AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0746p~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0245855	10/21/2005	TX	39.0	39		F	10/21/2005	Localized reaction with redness, swelling, fever at site and knot under skin arroximately the size of a baseball.									Y	10/19/2005	10/19/2005	0		UNK	UNK	none	none	none	Same as above~Influenza (Seasonal) (Fluzone)~1~0.00~In Patient		1						1	Injection site erythema; Injection site mass; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA123AC~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0245862	10/21/2005	CA	35.0	34		F	10/21/2005	Sneezing and stuffy, runny nose beginning 2-3 days after receiving FluMist.									U	10/18/2005	10/20/2005	2	NA	UNK	UNK	Prescription prenatal vitamin					1						1	Nasal congestion; Rhinorrhoea; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0245866	10/21/2005	PA	1.89	1	.9	M	10/21/2005	Within 24 hours of giving injection the site became markedly swollen, tender, red and indurated.  Patient was sent to hospital and was admitted.  He was treated for cellulitis and allergic reaction.  Per follow up report 11/09/2005 Please note patient has had Flu vaccine in past (10/25/2004 and 01/13/5 without reaction). Evaluation for possible neomycin allergy in process.					Y	2			Y	10/10/2005	10/11/2005	1	contact hospital for results,  no tests done in our office Medical records state leukocytosis. msv	UNK	UNK	singulair 4mg.	Upper respiratory infection/viral conjunctivitis	History of milk, soy, cat allergies tested negative to egg chronic otitis requiring pe tubes eczema, reactive airway disease			1						1	Cellulitis; Hypersensitivity; Injection site hypersensitivity; Injection site induration; Injection site oedema; Injection site pain; Leukocytosis	FLU3~SANOFI PASTEUR~U1794AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0245867	10/21/2005	IA	72.0	72		F	10/20/2005	One week after receiving the Td injection in right deltoid the patient developed a red, swollen area around the injection site with radiation of redness to the right elbow.  Hardness palpated under the skin.  No pain.  She reports itching.  Saw MD on 10/20/05 and was given Kenalog IM, and started on benadryl and cortisone cream.				Y					Y	10/11/2005	10/19/2005	8	None	UNK	UNK	None	No	None			1						1	Injection site erythema; Injection site induration; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U1761AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TTOX~SANOFI PASTEUR~U1220BA~5~IM~RA~TETANUS TOXOID, ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0245868	10/21/2005	MD	42.0	42		F	10/21/2005	Received a flu shot on Tuesday, October 18th.  Around 1 or 2 that afternoon she had a severe allergic reaction.  She had a heavy chest and couldn't breath, her eyes were red and glazed over with discharge, her mouth also broke out with hives.  She went to urgent care and they gave her Benedryl, a breathing treatment and Prednisone.  Yesterday she felt a lot better.  But around 11 AM today, it started to happen again, but she had neglected to take her meds because she had felt better the day before and went back to work.  She isn't allergic to eggs, so she thinks she may be allergic to the preservatives in the flu shot.  She just wanted to make sure we were aware of her incident with the vaccine so we could document her response.  She doesn't have information on the shot itself but provided the clinic and their phone number so we could contact them, get the info and then file a report. Short of breath, swollen glands, itchy throat, irritated red eyes, hives in moth, lips swollen, treated with IV Benadryl.				Y						10/18/2005	10/18/2005	0		UNK	UNK		Allergic reaction.				1						1	Chest pain; Dyspnoea; Eye discharge; Hypersensitivity; Ocular hyperaemia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0245869	10/21/2005	IL	27.0	27		F	10/21/2005	C/O light headedness, dizzy, sweating, nausea, weak, sore all over. Shivering V\S throughout.									Y	10/19/2005	10/19/2005	0	none	UNK	UNK		no	Pt. describes having multiple allergies and sensitivities to food and medications.			1						1	Asthenia; Chills; Dizziness; Hyperhidrosis; Nausea; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflu125bc~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0245873	10/21/2005	MO	38.0	37		F	10/21/2005	Patient states she got a severe headache and could not see out of Right eye.  Felt like a stroke.  Complained of nausea and vomiting and chest tightness.				Y					Y	10/19/2005	10/19/2005	0		UNK	UNK	Patient on several BP meds, Water pill, K+, asthma meds Advair, Albuterol, Isosorbide, Nifedical XL, Hydralazine,Catapril, Spirolactone	No, was being seen for routine follow-up visit.	CHF and Hypertension			1						1	Cerebrovascular accident; Chest discomfort; Headache; Nausea; Visual acuity reduced; Vomiting	FLU3~SANOFI PASTEUR~U1744AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245874	10/21/2005	CA	31.0	30		F	10/21/2005	I experienced severe hives on my arms, legs, feet, back and neck. I also was experiencing some swelling in my fingers and feet. My hives were very warm to the touch and looked like a sunburn. I noticed the hives the day after I rec'd my injection. I rec'd my injection on 10/18/2005 at approximately 2:20pm. I noticed the hives 10/19/2005 at approximately 10:30am. They contined until I was able to get an appointment on 10/20/2005 at 2:30pm. I had been taking my Atarax for the itching with some sign of itching relief, but not the hives disappearing. Once in the Dr. office I was given a shot of Benadryl and sent on my way. I have noticed the hives and itching are back after taking 2 doses of Atarax today 10/21/2005. Its bothersome.									Y	10/18/2005	10/19/2005	1	Benadryl injection given	UNK	UNK	I currently take Prozac, Zrytec, Nasarel, Atarax, Ibuprofin and a women's daily vitamin	none	Allergies to grass, trees, bushes, fontana weeds, Penicillin, Keflex			1						1	Feeling hot; Oedema peripheral; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0245885	10/21/2005	NY	45.0	45		F	10/21/2005	This case was reported by a healthcare professional and described the occurrence of worsened symptoms of bronchial asthma in a 45 yr old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The reporter is the subject. The healthcare professional also reported that two co-workers also experienced worsened symptoms of bronchial asthma following vaccination with Fluarix, however, subject identifiers were not provided. Concurrent medical conditions included asthma. Concurrent medications included unspecified asthma medications. On 05Oct05 the subject received the 1st dose of Fluarix. About 48 to 72 hrs after the Fluarix shot, on or after 07Oct05, the subject reported that her asthma symptoms worsened. The event had improved as of the time of initial reporting, 17Oct05. Worsened symptoms of bronchial asthma was assessed as medically serious by manf (OMIC).									N	10/05/2005	10/07/2005	2	UNK	PVT	PVT	Asthma medication	UNK	Asthma. The subject's concurrent conditions were not reported.		A05788884	1						1	Asthma	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0245889	10/21/2005	MA		55		F	10/21/2005	10/18/05 Within 2 hours of the shot, left eyelid was pinkish at eye lashes and swollen under eye. Bridge of nose was swollen, red, tender. Took Benadryl 50mg that night. Took Claritin D during the day with ASA, Motrin, and Benadryl 25mg last night and Claritin D, ASA and Motrin today. Also have bad headache.									U	10/18/2005	10/18/2005	0		PUB	UNK	Premarin; Nasal Spray; Claritin D		Mold, Dust, Ragweed, Sulfa			1						1	Eye swelling; Eyelid oedema; Face oedema; Headache; Ocular hyperaemia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA122AB~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0245890	10/21/2005	OH	37.0	36		F	10/21/2005	Face numb and swollen, rash around neck, chin/cheeks. Had to take steroids to get rid of.				Y					Y	10/17/2005	10/18/2005	1	NONE	PUB	UNK		NONE				1						1	Face oedema; Hypoaesthesia; Rash	FLU3~SANOFI PASTEUR~U1762AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245891	10/21/2005	IN	63.0	63		F	10/21/2005	Left Arm and shoulder pain. Unable to lift arm to even comb hair. Pain to touch or to lie on. Started Advil 10/20/2005. Pain woke her up from sleep on 10/19/2005 2am. pain started 11 pm day after shot. To Dr 10/21/2005  DR states deep bruise in muscle. Take Advil.				Y					Y	10/18/2005	10/19/2005	1		PVT	PVT	Potassium pill, Glucophage.		No allergies, High blood pressure, Pre diabetic takes potassium pills.			1						1	Contusion; Hypokinesia; Insomnia; Pain	FLU3~SANOFI PASTEUR~U1744AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245892	10/21/2005	LA	10.0	10		F	10/21/2005	Complaints of sinus symptoms (post nasal drip, sore throat, nasal congestion) and body aches morning of 10/19/05. Late that evening was in bed with mom eating pizza when mom states had seizure. Then had another 20-30 seconds after first one. Went to ER.				Y					Y	10/17/2005	10/19/2005	2	CT Scan negative 10/19/05. UA WNL; Chem Profile WNL; CDP WNL.	PVT	PVT	NONE	NONE	NKDA; Occasional otitis media and pharyngitis.			1						1	Convulsion; Nasal congestion; Pain; Pharyngolaryngeal pain; Postnasal drip	FLUN3~MEDIMMUNE VACCINES, INC.~500389P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0245893	10/21/2005	CO	68.0			F	10/21/2005	Redness, pain and swelling in Right arm from shoulder to elbow. Muscle aches especially in arms and legs, chills, and upset stomach began about 4 hrs after receiving vaccines. Today redness has nearly subsided, but swelling persists. Remaining symptoms abating. Treating with ASA and Zantac. She has had flu vaccines in the past, but the last dose was in 1998, Her previous pneumococcal vaccine was in 1999. Pt did inform vaccine provider of her AE.									U	10/19/2005	10/19/2005	0		OTH	OTH	Zantac, Multivitamin, Grape Seed, Green tea capsules	NONE	GI Reflux			1						1	Abdominal discomfort; Chills; Injection site erythema; Injection site oedema; Injection site pain; Myalgia	FLU3~SANOFI PASTEUR~U1805AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245875	10/22/2005	NC	50.0	50		F	10/22/2005	Difficulty breathing, hives, weakness, high fever.				Y					Y	10/12/2005	10/13/2005	1		UNK	UNK						1						1	Asthenia; Dyspnoea; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0245876	10/22/2005	AZ	52.0	52		F	10/22/2005	Skin rash with some hives covering entire front and back of torso. reddened skin under arms and groin area. swelling of nose and stiff neck, inflamed throat tissue. extreme fatigue. er tx adderax, prednisone injection sent home with prednisone 40mgx5days, claritin 10mg, rash reduced but not entirely clear by third day.				Y					U	10/20/2005	10/20/2005	0		UNK	UNK						1						1	Erythema; Face oedema; Fatigue; Musculoskeletal stiffness; Pharyngolaryngeal pain; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0245877	10/22/2005	PA	5.0	5		M	10/22/2005	Right quad tender to palpation. Swollen, hurts with knee flexion.  No hip pain, no knee effusion.				Y					U	10/21/2005	10/22/2005	1	none	UNK	UNK	none	upper respiratiry infection, afebrile	none			1						1	Pain; Swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14A006CA~5~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1815AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y05752~4~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0151R~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0245878	10/22/2005	CA	59.0	58		M	10/22/2005	About 3 hours after Flu vaccination, developed 100.0 F temperature, chills, wheezing, muscle aches and pains, nausea.									Y	10/22/2005	10/22/2005	0	None	UNK	UNK	Multiple--diabetes, hupertension	No	No			1						1	Chills; Myalgia; Nausea; Pyrexia; Wheezing	FLUX~UNKNOWN MANUFACTURER~~1~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0245879	10/23/2005	CA	68.0	67		M	10/23/2005	Shot administered on Tuesday October 17 in the lobby of the facility. On Wednesday I had a burning on the underside of my left arm. This continued until Friday night when I developed severe pain in my shoulder and left arm.  On Saturday I developed a large patch of bubbles where the shot was administered. The pain has increased and is very hard to tolerate. This is written Sunday morning October 23 and I am waiting to get into a facility...might be hard on Sunday.										10/17/2005	10/18/2005	1		UNK	UNK		None...was in clinic to see a dermatologist for a sore finger	None			1						1	Injection site rash; Shoulder pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0245880	10/23/2005	IL	2.0	2	.5	M	10/23/2005	Injection site - right deltoid received at 1630 on Friday, October 21, 2005.  Parents noticed entire right arm swollen, reddened and child scratching at injection site.  Mother began giving Benadryl for age to treat symptoms.  Right arm continued to swell with erythema & itching.  Parents brought child to ED for evaluation & treatment.				Y					Y	10/21/2005	10/22/2005	1	NONE	UNK	UNK		Extended local reaction from injection site.	NONE			1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0245881	10/23/2005	AL	7.0	6		F	10/23/2005	PT RECEIVED FLU MIST ON THURSDAY, HAD 3 RED ROUND AREAS TO LEG ON FRIDAY THAT RESOLVED. SUNDAY AM WOKE UP WITH GENERALIZED RED ROUND, FLAT  RASH . PT CAME TO ER ON SUNDAY AND WAS TREATED AND DISCHARGED TO FOLLOW UP WITH HER PRIMARY CARE MD.				Y					U	10/19/2005	10/23/2005	4		UNK	UNK		NONE	NONE			1						1	Erythema; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0245882	10/23/2005	AL	64.0	64		F	10/23/2005	PT RECEIVED PNEUMONIA, AND FLU SHOT ON THURSDAY, ON FRIDAY THE PT HAD A RED TENDER AREA AT INJECTION SITE.. ON SUNDAY PT REPORTS THE RED AREA HAD SPREAD AND HAD TENDERNESS HAD INCREASED.  PT CAME TO ER FOR TREATMENT. MD NOTED MOTTED REDDNESS TO INJECTION SITE. (SITE LT UPPER LEG)				Y					Y	10/19/2005	10/20/2005	1		UNK	UNK	none	routine check up	cortisone, allergy, medical history of bil mastectomy, htn, RA.			1						1	Injection site erythema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~RL~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0245883	10/23/2005	TX	70.0	69		F	10/23/2005	Constant clearing of throat. Coughing with severe pain in the esophagus from the bottom of my neck down the middle of my chest, so bad you did not want to cough. Hoarseness. Heart Rate over 100. Lasted 3 hrs at least, then I went to bed at 8:30 I was so tired.  I called the Dr to report this--Never received a return call---finally went to bed.									Y	10/20/2005	10/20/2005	0		UNK	UNK		None	codeine  Wasp Stings			1						1	Cough; Dysphonia; Fatigue; Heart rate increased; Nasal congestion; Pain	FLU3~SANOFI PASTEUR~U1807AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245894	10/24/2005	UT	31.0	31		F	10/21/2005	Wheezing, difficulty breathing, hoarseness, dizziness. they started appearing about 7:30-8pm during dinner. it was about 3 1/2 - 4 hours later. Went to Dr at earliest appointment which was at 11:40am the next day.				Y					Y	10/18/2004	10/18/2005	365		PVT	PVT		NONE	migraines, asthma, insomnia.			1						1	Dizziness; Dysphonia; Dyspnoea; Wheezing	FLU3~SANOFI PASTEUR~UNK~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245916	10/24/2005	WA	72.0	71		M	10/17/2005	According to spouse, the pt had difficulty breathing 4 hours later after the shot. He was taken to ER and kept overnight for observation. He was given Prednisone while in hospital. Infoirmationreceived from medical records states increased coughing. msv				Y	Y	1			Y	10/14/2005	10/14/2005	0		OTH	PVT	Prednisone 5 mg Daily and Albuterol Inhaler used as needed; Lovastatin 40 mg daily	NONE	Asthma/Heart Condition  Information received from Medical records states lung disease, tobacco use. msv			1						1	Cough; Dyspnoea	FLU3~SANOFI PASTEUR~U1805AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0245920	10/24/2005	TN	35.0	35		F	10/20/2005	162/34 dysautonomia. Influenza virus vaccine, 35 yr old nurse had sudden loss of peripheral vision on left while at work with some numbness in her hands and feet which had been transient since an influenzae vaccine 10/11. She presented to Emergency dept 10/11 and was returned 10/16 for admission. At that time she was suspected of pulmonary edema and was given Lasix. Blood pressure and heart rate had decreased after admission. She had no headache, nausea, vomiting, dizziness. Neurological exam was otherwise unremarkable. CT of the head in the ER was negative for acute change. She was admitted to the hospital with diagnosis of possible scotoma from a migraine without associated headache. MRI/MRA of head and neck obtained at the hospital were normal. Labs were obtained for hypercoag status and were normal. Thyroid functions were normal and she had no further visual symptom after admission. She did have sinus bradycardia and some transient hypotension that was felt secondary to dysautonomia from her vaccine. She was started on Medrol Dosepak just prior to discharge 10/18. The next day pt had tingling and heart rate of 40. Follow up appt's were made with cardiology. Lot U1832BA Fluzone exp 6/30/06. Information from medical record states pneumonia. msv Employee states still has episodes of decreased blood pressure & heart rate					Y	2			N	10/11/2005	10/11/2005	0	infromation from medical record states abnormal lab test. msv	UNK	UNK			Information from medical record states asthma, trial septial defect. msv			1						1	Autonomic nervous system imbalance; Heart rate irregular; Hypoaesthesia; Hypotension; Laboratory test abnormal; Migraine; Paraesthesia; Pneumonia; Pulmonary oedema; Scotoma; Sinus bradycardia; Visual disturbance; Visual field defect; Autonomic nervous system imbalance; Blood pressure decreased; Headache; Hypoaesthesia; Hypotension; Migraine; Paraesthesia; Scotoma; Sinus bradycardia; Visual field defect	FLU3~SANOFI PASTEUR~U1832BA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1832BA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0245921	10/24/2005	GA	0.0			M	10/24/2005	Saucer sized area on right upper arm below area where shot was given was red and warm to touch. Patient ran temp of 101.8 on night of 10/20/05 and lower temps on 2 subsequent nights. Has not checked temp since 10/22. Had itching of the area later on.  Has noticed improvement.  There is still slight pink color to area but condition has improved.									Y	10/20/2005	10/20/2005	0		UNK	UNK	Takes high blood pressure medication, 3 other meds wife can't remember (husband hard of hearing, wife made phone call)	None	Allergic to PCN			1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Injection site warmth; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~U1762AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~2~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245923	10/24/2005	CO	74.0	74		M	10/24/2005	Sore throat, congestion, cough, body ache, Ibuprofen, 200 mg four times a day.									Y	10/15/2005	10/15/2005	0		UNK	UNK	Sinemet 200/800/day, Requip 7 mg/day, Acyclovir 800 mg/day, Aspirin 325 mg/day	none	Parkinsons, Restless Legs Syndrome			1						1	Cough; Nasal congestion; Pain; Pharyngolaryngeal pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0245924	10/24/2005	WI	58.0	57		F	10/24/2005	States that a 8 p.m. she started to notice hoarseness in her voice and started with a deep persistant cough.  She then when on to have difficulty breathing, tightness in her chest, hives, paleness, weakness, tachycardia, dizziness, abdominal cramping, shortness of breath, and she shook uncontrollably.  She called 911 and was taken to hospital where she was admitted to the ICE Thursday evening and was moved to a regular room on Friday evening and was discharged on Saturday. Discharge summary states angina. msv				Y	Y	2			Y	10/20/2005	10/20/2005	0	Lab tests were done. Was a patient in a hospital. Discharge summary states Hypokalemia, EKG abnormal. msv	UNK	UNK	Atenolol, ASA and Nitroglycerine.	No illness at the time of vaccination.	Allergies - IVP dye, Sudafed Has a cardiac history of leaky valves Discharge summary states tobacco abuse, Hx of Palpitations, Mitral insufficency. Medical record states Hx of tachycardia. msv			1						1	Abdominal pain; Angina pectoris; Asthenia; Chest discomfort; Cough; Dizziness; Dysphonia; Dyspnoea; Electrocardiogram abnormal; Hypokalaemia; Pallor; Tachycardia; Tremor; Urticaria	FLU3~SANOFI PASTEUR~U1831AB~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0245926	10/24/2005	ID	78.0	78		F	10/24/2005	c/o extremely sore left arm from neck to fingers. unable to move arm.  Pain started soon after injection and continued to increase throughout the evening.  Tried to apply heat but was too painful.  Fainted upon arising the next morning.  No redness or swelling noticed.  Advised ibuprofen. Contiued to have pain and extreme fatigue and malaise until 10/24/05									Y	10/21/2005	10/21/2005	0		UNK	UNK	Altace, Thyroid, Zocor, Actonel	none				1						1	Fatigue; Malaise; Pain; Syncope	FLU3~SANOFI PASTEUR~U1807AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0746P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245928	10/24/2005	MD	65.0	64		M	10/24/2005	Pneumococcal vaccine (along with flu vaccine) administered 10/11/05. On second day (10/12), fever began(reaching 102.6 F on 10/13-14). Beginning late 10/11, experienced redness, heat and pain in arm where administered. Arm pain and sensitivity disrupted/prevented sleep. Fever did not subside with self administered dosage of two ibuprofin pills (2 * 200mg) @ 4 hrs. Visited MD on fourth day (10/14). Dr. diagnosed bacterial infection in left (Pneumovax) arm. On doctor's prescription, took Cefzil antibiotic (500 mg twice a day) and, upon increasing ibuprofin dosage to 4 * 200 mg @ 8 hrs, fever began to subside. Total duration before relief: fever began second day, ended on fifth or sixth day (10/15-16). Arm swelling, pain and sensitivity persisted to seventh or eighth day (10/17-18).				Y					Y	10/11/2005	10/12/2005	1		UNK	UNK	Lipitor; Norvasc; Toprol XL; Altace.					1						1	Bacterial infection; Erythema; Injection site warmth; Pain; Pyrexia; Sensory disturbance; Sleep disorder; Swelling	FLU3~SANOFI PASTEUR~U1762AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0791P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245929	10/24/2005	KS	26.0	26		F	10/24/2005	Dizzy, thick tongue, racing heart, red ears. Benadryl 50mg im given.									U	10/24/2005	10/24/2005	0	none	UNK	UNK	labetalol	no	htn			1						1	Dizziness; Erythema; Heart rate increased; Tongue disorder	FLU3~SANOFI PASTEUR~u1756aa~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245931	10/24/2005	OK	63.0	63		M	10/24/2005	Immediate nausea, vomiting, weakness and severe dizziness.										10/22/2005	10/22/2005	0		MIL	OTH	21 others, on insulin pump	none. is diabetic heart problems	diabetes, heart condition			1						1	Asthenia; Dizziness; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0245932	10/24/2005	GA	5.0	5		F	10/24/2005	10/19/05 25 cent red area around injection site of left leg. 10/20/05 25 cent red area with itching 10/21/05 6 x 4 red,hot area,sent to ER by HD staff. Dx was allergic reaction local infection. Treated with Keflex, prednizone, benadryl. 10/24/05 area pink same size.				Y					Y	10/19/2005	10/19/2005	0	none	UNK	UNK	none	none	asthma			1						1	Hypersensitivity; Injection site erythema; Injection site hypersensitivity; Injection site infection; Injection site warmth; Pruritus	DTAP~SANOFI PASTEUR~u1343ca~5~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~u1804aa~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~x1212~2~SC~LL~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0602r~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0245933	10/24/2005	KY	66.0	66		F	10/20/2005	c/o coughing spasms, throat tightness, wheezing and blurred vision within 3 hours after vaccine, blurred vision and sore throat continued and eyes started matting.  Patient sent to MD, recieved corticosteroid shot and rx for antihistamines/eye gtts.  Continues to feel kind of tired today.				Y					Y	10/20/2005	10/20/2005	0		UNK	UNK		no	no, takes Tylenol arthritis every day prn and vitamins		KY2005033	1						1	Cough; Eye discharge; Fatigue; Pharyngolaryngeal pain; Throat tightness; Vision blurred; Wheezing	FLU3~SANOFI PASTEUR~U1744AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245934	10/24/2005	PA	46.0	46		M	10/24/2005	Vaccination was on Sunday 10-23-2005 at approx 4:00pm.  At approximately 1:00am 10-24-2005 patient was experencing high fever, chills and shaking, slight headache.  Advil reduced fever and seemed to calm the shaking.  Patient visited family physician as a precaution. If fever doesn't go away after 24 hours doctor instructed the patient to get a chest x-ray and blood work.									U	10/23/2005	10/24/2005	1		UNK	UNK		none	none			1						1	Chills; Headache; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245938	10/24/2005	MT	47.0	47		F	10/24/2005	Within 2 hours of injection, got a dry mouth, felt kind of woozy and was kinda numb and tingly down her legs.  Eyes kind of blurry.  Had trouble feeling her feet.  Symptoms persisted for approximately 2 hours and were gone by 1900.									Y	10/21/2005	10/21/2005	0	NA	UNK	UNK	Lexapro, Buspar, Lorazepam, Lunesta, Tetracycline (for acne)	None				1						1	Dizziness; Dry mouth; Hypoaesthesia; Paraesthesia; Vision blurred	FLU3~SANOFI PASTEUR~U1764AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245940	10/24/2005	KY	39.0	39		F	10/24/2005	Patient reports about 2hrs. after injection had difficulty catching breath, gasping.  Went to drug store and purchased Primetine inhaler.  Took two puffs and felt better, 1 hour later took another puff and went to bed.  During night had night sweats. Heart rate seemed rapid, face flushed.									Y	10/19/2005	10/19/2005	0	None	UNK	UNK	Lisinopril 10 mg. Glucophage	None	High Blood Pressure, Type 2 Diabetes			1						1	Dyspnoea; Flushing; Heart rate increased; Night sweats	FLU3~SANOFI PASTEUR~U1775AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245942	10/24/2005	CA	52.0	51		M	10/24/2005	Patient stated on 10/21/05 @ 1400 that he had some type of reaction from the flu shot given on 10/19/05.  Pt stated that his chest broke out into hives and his arm is red. the nurse obseved the following, after the sleeve of the (L) arm was pulled up it was (bright), hard and warm to the touch.  the chest area from the bottom of the neck was very red similar to a person blushing or being flushed on a hot day.  From the top of the collar bone the area was concentrated red then began to get less and less red as it descended to the nipple area of the chest.				Y					Y	10/19/2005	10/21/2005	2	None	UNK	UNK		None	Unknown			1						1	Erythema; Injection site erythema; Injection site induration; Injection site warmth; Urticaria	FLU3~SANOFI PASTEUR~U1745AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245943	10/24/2005	AZ	72.0	71		M	10/24/2005	This case was reported by a consumer and described the occurrence of facial palsy in a 71 year old male subject who was vaccinated with Fluarix for prophylaxis. The reporter is the daughter of the subject. A physician or other health care professional has not verified this report. The subject had no pre-existing medical conditions. There were no concurrent medications. On 15 October 2005 the subject received 1st dose of Fluarix in the right arm. On 19 October 2005, 4 days after vaccination with Fluarix, the subject experienced an ear ache. On 20 October 2005, the subject experienced facial paralysis. The subject was taken to a doctor's office after (he) thought he had experienced a stroke. The subject was diagnosed with facial palsy and an ear infection. The subject was treated with steroids for facial palsy and antibiotics for ear infection. At the time of initial reporting, 21 October 2005, the events were ongoing. Comment: Facial palsy was assessed as medically serious by the manufacturer (OMIC).				Y					N	10/15/2005	10/19/2005	4	UNK	OTH	PUB	NONE	UNK	NONE		A0579214A	1						1	Ear pain; Facial palsy; Otitis media	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0245959	10/24/2005	TX	37.0	37		M	10/24/2005	Headaches, sinus pain and vertigo, joint pains.									Y	10/18/2005	10/19/2005	1		PVT	PVT						1						1	Arthralgia; Headache; Sinus headache; Vertigo	FLU3~SANOFI PASTEUR~U1761AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245960	10/24/2005	TX	78.0	77		M	10/20/2005	Pt received vaccines to left deltoid region 10/19/2005 as has had Flu vaccine before but not Pneumococcal PPV 23. C.O 2 days after vaccine developed moderate swelling and reddened area from shoulder to elbow, painful to touch. Applied cold compresses. Area warm to touch. no numbness, tingling or continuous pain. Pt voices able to move extremity without discomfort. No fever.									Y	10/19/2005	10/19/2005	0		PUB	PUB	anticoagulant, anti diabetic needle.		Diabetes, Heart problems			1						1	Feeling hot; Hypersensitivity; Oedema; Pain	FLU3~SANOFI PASTEUR~U1838AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0578P~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245965	10/24/2005	PA	1.26	1	.3	F	10/21/2005	Rash and blotchy skin on face and legs. child very irritable and crying.									U	10/18/2005	10/21/2005	3		PVT	UNK						1						1	Agitation; Crying; Irritability; Rash; Rash macular	FLU3~SANOFI PASTEUR~U1819AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE338AD~4~IM~RL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~Y04602~3~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~A94440H~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0245966	10/24/2005	MA	24.0	24		F	10/12/2005	Within minutes developed erythema and swelling which increased as time passed. Some shortness of breath history of asthma.				Y					Y	10/12/2005	10/12/2005	0	Chemistry elevated glucose 114, CBC elevated Poly 85, Neuts 19.62, Mono .96	PUB	PUB			Asthma, Anaphylaxis with penicillin			1						1	Blood glucose increased; Dyspnoea; Erythema; Laboratory test abnormal; Oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLV9130BB~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0245967	10/24/2005	MT	72.0	71		F	10/18/2005	Evening following vaccine injection, developed large reddened, sore, hot to touch area on arm, no fever. Gradually resolving. Related to Pneumonia site.									Y	10/14/2005	10/14/2005	0		PUB	PUB	UNK		UNK			1						1	Feeling hot; Injection site hypersensitivity; Injection site pain; Injection site reaction	FLU3~SANOFI PASTEUR~U1905AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0371P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245968	10/24/2005	CA	80.0	80		F	10/14/2005	Pt c/o pain, swelling up the right arm and neck, no respiratory distress.									Y	10/10/2005	10/12/2005	2		OTH	OTH	Prevacid, Prozac	Right shoulder pain S/P fall	Allergy Morphine			1						1	Oedema; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~UNK~UNK~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0245969	10/24/2005	PA	4.0	4		M	10/11/2005	9 x 9 cm red and indurated patch, right upper outer thigh. Benadryl 1tsp Q 6 hrs.									Y	10/07/2005	10/08/2005	1		PVT	PUB		NONE				1						1	Hypersensitivity; Injection site induration	DTAP~SMITHKLINE BEECHAM~AC14A010BA~4~~RL~DTAP (INFANRIX)~1|FLU3~AVENTIS PASTEUR~U1794AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y02642~4~~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0346P~2~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0245970	10/24/2005	GA	66.0	66		M	10/21/2005	Right upper arm red and warm to touch, pt c/o soreness in the area.										10/19/2005	10/20/2005	1	NONE	PVT	PVT	Vitamins, Hyzaar, Coumadin	Sinusitis	Chronic bronchitis, Aortic stenosis, BPTH			1						1	Feeling hot; Hypersensitivity; Pain; Sinusitis	FLU3~SANOFI PASTEUR~U1794AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1006P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0245971	10/24/2005	CO	4.0	4		F	10/18/2005	Received vaccine in afternoon, approximately 2-3 hours later the child developed systemic urticaria.									Y	10/17/2005	10/17/2005	0		PVT	PUB		NONE	NONE			1						1	Urticaria	DTAP~SANOFI PASTEUR~U1396DA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~V1846A4~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0400R~2~IM~LL~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~X1244~4~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0556P~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0245972	10/24/2005	PA	70.0	70		F	12/07/2005	A high fever and was very lethargic. Left arm had hives, redness, swelling and hot to the touch from pectoral muscle to bend in arm. Could not lift arm for a day and a half without pain. Continue to have a picking sensation, soreness and discomfort in arm. Follow up: Arm swollen, turned red. Fever (did not take until next day 101 F). Felt tired. Went to bed. Went to Hosp ER states she was given 2 pills and sent home. Doesn't know what they were. Thinks it was a steroid.				Y					Y	10/07/2005	10/07/2005	0	None	PUB	PUB	Coenzyme, Zocor, Fosinex, Phosamax	NONE	High Cholesterol			1						1	Discomfort; Feeling hot; Hypersensitivity; Hypokinesia; Lethargy; Oedema; Pain; Paraesthesia; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U1804AA~2~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1040P~2~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0245973	10/24/2005	KY	71.0	71		F	10/18/2005	Heart palpitating, nausea, headache from hell, blurred vision, Hot burning, chills, shaking, fever, unquenchable thirst, very bad taste in mouth, 17 hours, prescribed Benadryl.									Y	10/03/2005	10/03/2005	0		PVT	UNK	Detropan XL, Sumycin.	NONE	Celebrex, acromycin, Darvon, macredantin, Augmentin, gauifenpse			1						1	Cardiac disorder; Chills; Dysgeusia; Headache; Hot flush; Nausea; Palpitations; Pyrexia; Thirst; Tremor; Vision blurred	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~UNK~UNK~~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0245974	10/24/2005	GA	21.0	21		M	10/12/2005	Pt felt dizzy, lightheaded. Face was flushed and burning sensation. No other treatment.									Y	10/12/2005	10/12/2005	0		MIL	MIL	Rantidine, Zyrtec, Prednisone	UNK				1						1	Dizziness; Flushing; Skin burning sensation	FLUN3~MEDIMMUNE VACCINES, INC.~500390P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0245975	10/24/2005	TX	58.0	58		F	10/18/2005	The injection for the flu vaccine was improper administered. The injection was given on top of the left shoulder and not on the upper arm side. This caused a 2 diam. hematoma. Continued bleeding for one day and I have continued pain on side of neck, all the way down to left arm.				Y					N	10/11/2005	10/11/2005	0	On doctor visit on 10/13/05, doctor stated injection was given in improper place by nurse.	OTH	PVT	NONE	Large 2 dia hematoma, bleeding one whole day and pain to this day.	NONE			1						1	Haematoma; Injection site haemorrhage; Injection site pain; Medication error; Neck pain	FLU3~SANOFI PASTEUR~U1811AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245976	10/24/2005	WA	38.0	37		F	10/11/2005	10/7/05: swelling on right eye (mild). 10/18/05: rash on face (temple area) and neck, increased swelling at right eye. 10/9/05 - 10/11/05: rash, increased swelling. Treatment: Benadryl as needed/ Zyrtek as needed.									Y	10/07/2005	10/08/2005	1	NONE	MIL	MIL	Zyrtec	NONE	NONE			1						1	Eye oedema; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500387P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0245977	10/24/2005	TX	47.0	47		F	10/15/2005	Fever, (rash around injection) body aches and pain/chills, headache (severe) weakness. General feeling of killer flu. Stayed in bed due to adverse side effects of flu vaccine.  Needed to go to to hospital but could not afford to.				Y					U	10/11/2005	10/11/2005	0		PVT	OTH	Synthroid 0.15	NONE				1						1	Asthenia; Chills; Headache; Influenza like illness; Injection site pain; Injection site rash; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U17778A~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245978	10/24/2005	MA	1.02	1	.0	M	10/18/2005	Rash at site erythematous, 10 day after vaccination, no systemic symptoms other than fever other siblings w/ fever and wild sx.										10/07/2005	10/17/2005	10		PVT	PUB	NONE					1						1	Injection site rash; Pyrexia; Rash erythematous	FLU3~SANOFI PASTEUR~41743JA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0610P~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A617187E~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1097N~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0245979	10/24/2005	HI	8.0	8		M	10/17/2005	Flu shot given 10/7/05 AM about 0800. About 12h later, pt rash developed on pt's neck and face that progressed to swelling of eyelids and lips. Pt treated with Benadryl and Relone.				Y					Y	10/07/2005	10/07/2005	0		PVT	PVT	NONE	NONE	NONE			1						1	Eyelid oedema; Face oedema; Rash	FLU3~SANOFI PASTEUR~U1754AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245980	10/24/2005	UT	46.0	45		F	10/17/2005	Swollen arm.				Y						10/07/2005	10/10/2005	3		OTH	PVT						1						1	Oedema	FLU3~SANOFI PASTEUR~U1811A~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0490P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246010	10/25/2005	CA	77.0	76		F	10/20/2005	Diffuse angioedema of face. Quite impressive looking.									Y	10/17/2005	10/17/2005	0		PVT	PVT		NONE				1						1	Angioneurotic oedema	FLU3~SANOFI PASTEUR~U1905AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246011	10/25/2005	FL	79.0	78		M	10/21/2005	5:00 pm extreme shaking, temperature 102.2, Blood pressure 180/75, temperature started to go down slowly about 7:30 pm. Blood pressure stabilized.									Y	10/12/2005	10/12/2005	0		MIL	OTH	Gemfibrozil, metoprolol, Simvastatin, Hydrochlorothiazide	NONE	Has artificial mitro valve, Diabetes			1						1	Blood pressure increased; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246012	10/25/2005	ME	3.0	3		M	10/25/2005	Cellulitis				Y					Y	10/20/2005	10/21/2005	1		PVT	OTH		NONE	RAD as infant, not active currently.			1						1	Cellulitis	FLU3~SANOFI PASTEUR~U1787BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246013	10/25/2005	WA	70.0	70		M	10/25/2005	Fever, chills, sore left arm, headache.  Felt better by Sunday.  Took Dayquil.									Y	10/20/2005	10/20/2005	0		PVT	PVT	Lipitor, aspirin, Prednisone, Neoral.	NO	Rheumatoid Arthritis, Cholesterol.			1						1	Chills; Headache; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0246014	10/25/2005	NC	53.0	52		F	10/24/2005	Flu-like symptoms, hoarseness, cough, colored sputum, achy, tired.  Site of injection is hot, burning throat, fever.  Has been taking over the counter medication.  Today feels much better but still weak, and burning throat.									U	10/12/2005	10/13/2005	1		OTH	OTH	NO		Colitis, Meneires Disease.			1						1	Asthenia; Cough; Dysphonia; Fatigue; Influenza like illness; Injection site warmth; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA1328A~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246015	10/25/2005	CT	6.0	5		F	10/05/2005	11:00AM patient had check up.  Has Asthma, mild cold symptoms, resolving cold.  Flu shot, 1st one ever, reaction with trouble breathing, increased wheezing, cough, vomited.  Oxygen saturation 81 RA, increased to 99 with oxygen.  Treated with Benadryl.  Called 911 to ER via ambulance.			Y						Y	10/05/2005	10/05/2005	0	Oxygen sats monitored in office.	PVT	PVT	NONE	Resolving mild cold symptoms	History of mild interm. Asthma - controlled.		CT 2005-06	1						1	Asthma; Condition aggravated; Cough; Dyspnoea; Vomiting; Wheezing	FLU3~SANOFI PASTEUR~U1829AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0246016	10/25/2005	GA	57.0	57		F	10/24/2005	Profuse sweating but felt ice cold.  Felt weak, nauseated, couldn't get out of bed.  Flu-like symptoms.  Today she is feeling so-so, nauseated, not cold.									Y	10/23/2005	10/23/2005	0		OTH	PVT	Multivitamin, Vitamin C, Insulin, Lantus, Lasix, Androlan, Layastatin, Synthroid.		Diabetes, Hypertension, Thyroid, Cholesterol.			1						1	Asthenia; Feeling cold; Hyperhidrosis; Influenza like illness; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246017	10/25/2005	PA	49.0	49		F	10/24/2005	Sleep all afternoon, sluggish, on 10/23 had hoarseness, difficulty breathing, wheezing, fast heart beat, light-headed.  Called doctor at night:  took Tylenol for fever which helped.  Coughing and wheezing today, used Albuterol Nebulizer.									U	10/22/2005	10/22/2005	0		OTH	PUB	Zyrtec, sono, aspirin, corolenol, singulair, resiptann	sinus draining	leukemia			1						1	Cough; Dizziness; Dysphonia; Dyspnoea; Heart rate increased; Sluggishness; Somnolence; Wheezing	FLU3~SANOFI PASTEUR~~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246018	10/25/2005	NJ	79.0	78		F	10/24/2005	Runny nose, fever, headache, loss of appetite, lethargic, couldn't sleep, dizzy.  Today she feels congested.									U	10/18/2005	10/19/2005	1		PUB	PUB	NO	NO	Leaf dusty allergy.			1						1	Anorexia; Dizziness; Headache; Insomnia; Lethargy; Nasal congestion; Pyrexia; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246026	10/25/2005	KY	7.0	7		M	10/25/2005	10/12/2005 - left arm red area about 4cm diameter, hot and painful to touch, monitored and treated with Motrin.  10/12 vomiting, went to ER, diagnosed with virus and Cellulitis.  Treated with IV Rocephin and Augmentin.									Y	10/10/2005	10/12/2005	2	N/A	PVT	UNK	Singulair and Zyrtec, Advair, Albuterol, Prevacid	No	Asthma			1						1	Cellulitis; Oedema peripheral; Pain; Viral infection; Vomiting	FLU3~SANOFI PASTEUR~U1778AA~4~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0386P~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246030	10/25/2005	SC	67.0	66		F	10/25/2005	Health department nurse received phone call from RN at patient's MD office.  Nurse reported client at home and had a seizure following the same morning receipt of a flu shot.  EMS called and arrived at home.  Patient not taken to ER or hospitalized.  Patient has history of epilepsy and has received flu vaccine in the past.									Y	10/20/2005	10/20/2005	0		UNK	UNK	NONE	History of epilepsy	NONE		SC0518	1						1	Convulsion	FLU3~SANOFI PASTEUR~U1764AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246031	10/25/2005	MS	15.0	15		F	10/25/2005	On the day following vaccination, patient developed confluent pruritic maculopapular rash on elbows and knees which spread to buttocks and upper arms and ear pinnae over the next two days.									U	10/21/2005	10/22/2005	1	Rapid strep test negative 10/21/05 and 10/24/05 in office.	UNK	UNK		Patient presented 10/21/05 with nasal congestion and c/o myalgia on right side of neck and temperature of 99.3.  Moderate erythema of oropharynx noted on exam along with a fine perioral rash.  Rapid strep test negative 10/21/05, patient diagnosed with viral pharyngitis and flu vaccine offered and given at this visit.	none			1						1	Pruritus; Rash maculo-papular	FLU3~SANOFI PASTEUR~U1755AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246032	10/25/2005	IN	12.0	12		F	10/25/2005	Vasovagal response approximately 3 minutes following injection; some tonic-clonic movements noted.									Y	10/14/2005	10/14/2005	0		UNK	UNK						1						1	Dyskinesia; Syncope vasovagal	FLU3~SANOFI PASTEUR~U1846AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246033	10/25/2005	TX	28.0	28		F	10/25/2005	Pt. waited approx 10 min. in our office and had no symptoms. But approx 20 minutes later she felt faint and passed out while driving.  She required emergency abdominal exploration for bleeding and her injuries included pneumothorax, liver laceration, and vena cava laceration which required R. nephrectomy.  12/20/05 Reviewed medical records. Add accident with injuries.			Y		Y	31			Y	10/21/2005	10/21/2005	0		UNK	UNK	none Per review of medical records on 11/07/05 - Flonase	none	none known Per review of medical records on 11/07/05, patient was diagnosed with allergic rhinitis on 9/21/05. She had a history of childhood asthma and depression.			1						1	Abdominal exploration; Dizziness; Injury; Loss of consciousness; Nephrectomy; Pneumothorax; Road traffic accident; Traumatic liver injury; Vena cava injury	FLU3~EVANS VACCINES~61123~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0246034	10/25/2005	WI	73.0	72		F	10/25/2005	Client had very sore, reddened and swollen arm with pain radiating to neck region.									Y	10/17/2005	10/18/2005	1	none	UNK	UNK	unknown	unknown	unknown			1						1	Erythema; Pain; Swelling	FLU3~SANOFI PASTEUR~U1744AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0967P~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~MASS. PUB HLTH BIOL LAB~Td129~1~IM~RA~TD ADSORBED (TDVAX)~1	USA		Influenza
0246036	10/25/2005	OK	51.0	51		F	10/25/2005	I received the vacc. at about 5 pm,  At 10 pm that evening I starting running a fever between 102 and 103.  Severe chills, a terrible headache, body aches, some nausea.  The fever finally broke the middle of the next morning.  I just felt like I had a terrible case of the flu.  I did experience some congestion and wheezing.									Y	10/24/2005	10/24/2005	0		UNK	UNK		none				1						1	Chills; Headache; Nasal congestion; Nausea; Pain; Pyrexia; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246039	10/25/2005	IL	72.0	72		F	10/25/2005	The client received pneumonia vaccine in R deltoid at approximately 10 AM on Friday, 10/21/05.  As day progressed, client states the injection site became increasingly red, painful and swollen and the swelling and redness continued down to the elbow.  The area was still red and somewhat painful when seen on Monday, 10/24/05.  Client did not contact her physician but was advised to consult with her physician before recieving another pneumonia vaccination.									Y	10/21/2005	10/21/2005	0	No tests done.	UNK	UNK	Unknown	None reported.	None reported.			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1838AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246040	10/25/2005	TX	40.0	39		F	10/25/2005	RECEIVED INACTIVATED INFLUENZA VACCINE 10-24-05, GIVEN IM IN LT DELTOID. ON 10-25-05 AWOKE WITH A PRURITIC DRY RED PAPILLARY RASH INVOLVING NECK, TRUNK, BACK AND PROXIMAL LOWER EXTREMITIES.  SHE DID NOT FEEL NOR APPEAR ILL. HAD NO FEVER, RHINORRHEA, MALAISE. NO OTHER KNOWN EXPLANATION FOR THIS RASH. I TREATED HER TODAY WITH DIPHENHYDRAMINE BY MOUTH. No additional terms added from Discharge Summary rec'd 11/10/2005/sr										10/24/2005			NONE	UNK	UNK		NONE.	NONE			1						1	Erythema; Rash; Rash pruritic	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA154BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246043	10/25/2005	AZ	60.0	60		F	10/25/2005	HA severe, question meningeal irritation, joint discomfort, 2 d hx of ha, n/v. D/C diagnosis is aseptic meningitis with likely combination of viral infection and complications from immunization with minimal CSF pleocytosis. Infection Control filled this out form and more information regarding vaccine administration and lot # and manufacturer are not available to me. The pt stated she received 3 vaccines at the same time, Flu, Pertussis/tetanus, Pneumo vacc. Discharge summary states headache, nausea, vomit, viral infection, meningitis. msv					Y	3			Y	10/14/2005	10/16/2005	2	CSF panel (only 6 wbc's 70%segs, 20%lymphs 8%mono's, glu 62, pro 60) CSF bacterial Cx with no growth after 5 days Discharge summary states abnormal CSF. msv Medical record states ketosis. msv	UNK	UNK		Hx pleurisy and pericaridal inflammation during this time.	Discharge summary states pleural effusion, arthritis, pericardial effusion. msv			1						1	Arthralgia; CSF test abnormal; Headache; Ketosis; Meningism; Meningitis; Nausea; Viral infection; Vomiting	DTAP~SANOFI PASTEUR~C2151AC~UNK~UN~UN~DTAP (DAPTACEL)~1|FLU3~AVENTIS PASTEUR~U1777AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0967P~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0246046	10/25/2005	CO	67.0	67		M	10/25/2005	Received pneumonia shot about noon 10/19/05 in my right arm. My arm began to hurt by 4PM that afternoon.  I could not lift my arm.  Put ice pack on the resat of the day.  Next morning, my right arm was 2-3times the size of my left arm.  It was very tender.  I called the doctor after breakfast.  I was instructed to continue with ice and take Tylenol for the pain.  I did that for the remainder of the day. I got up Friday, October 21 and my arm was hot to the touch, the swelling was from my shoulder to be;ow my elbow. My arm was red from my shoulder to my wrist.    Called the doctor once again.  Described my arm.  I was told to come in to see the doctor.  Once the doctor saw the arm, he said it was infected, celullitis.  He prescribed amoxicillin										10/19/2005	10/19/2005	0		UNK	UNK		None				1						1	Cellulitis; Erythema; Hypokinesia; Infection; Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~V1792A13~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246047	10/25/2005	MO	80.0	79		M	10/25/2005	Large red hives with blisters beginning at left deltoid and going down left arm.				Y					U	10/20/2005	10/25/2005	5		UNK	UNK	allopurinol aricept aspriin lisinopril claritin prilosec timolol eye gtts toprol xl zyprexa	none	No known drug allergies, has diagnosis of mental retardation, dementia, and hypertension.			1						1	Blister; Urticaria	FLU3~SANOFI PASTEUR~u1828aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246048	10/25/2005	FL	39.0	38		F	10/25/2005	Pain at injection and local induration.  Seen in the ER and treated w/ course of abx for presumed cellulitis.  Seen by doctor after ER and given course of Antihistamine, Steroids, and H2 Blocker.				Y					U	10/19/2005	10/19/2005	0	None known	UNK	UNK	Trivora Darvocet N100 Allegra Norvasc Lipitor Avapro Proventil Keflex Prednisone	None known	Environmental Allergies and Cats  Hypertension Hypercholesterolemia Asthma Allergic Rhinitis Nasal turbinates hypertrophy Shoulder Arthritis Sleep Walking			1						1	Cellulitis; Injection site induration; Injection site pain	FLU3~SANOFI PASTEUR~u1753aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0704p~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246049	10/25/2005	TX	87.0	87		F	10/25/2005	About an hour or so later her arm started to hurt from the shoulder down to the wrist area.  She began to feel weak.  Pt thought having an MI.  Went to ER and put on monitors.  All tests came back normal but ER doc felt like was possibly a reaction to the vaccination.				Y					Y	10/18/2005	10/18/2005	0	None given	UNK	UNK	Coumadin Lipitor Micardis	No	Allergic to penicillin Hypertension			1						1	Asthenia; Pain	FLU3~SANOFI PASTEUR~U1830AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246051	10/25/2005	MN	55.0	54		F	10/25/2005	Hoarseness  10-12-o5 til present.				Y						10/12/2005	10/16/2005	4		UNK	UNK		end of bladder infection				1						1	Dysphonia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246054	10/25/2005	WA	64.0	64		F	10/25/2005	6-7 hours later developed erythema all over the body, hands swelled up, generalized pruritis, tongue swelled and felt like larynx was swelling. No wheezing, but chest felt tight. 12/30/09 ER records received for date 10/12/09. DX: allergic reaction. Presenting c/o pruritis, rash, tongue swelling. Assessment: diffused erythmatous rash.				Y					Y	10/12/2005	10/12/2005	0	None. ER Report reviewed. Patient had already taken benadryl. ER gave Ranitidine 150, sq Epi, and prednisone 60 mg PO. Sent out on 4 days of prednisone. Reaction resolved in ER.	UNK	UNK	Chronic meds, not recently changed, Lipitor 10 mg q d, Trazadone hs, HCTZ 25 mg daily	None	HTN, fibromyalgia, and dyslipidemia.			1						1	Chest discomfort; Erythema; Laryngeal oedema; Oedema peripheral; Pruritus; Tongue oedema	FLU3~AVENTIS PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246061	10/25/2005	PA	12.0	11		F	10/24/2005	Local rash (red, raised, tiny papular lessions, + edema on left deltoid + tenderness) 12.5 cm length x 6 cm width.									N	10/19/2005	10/20/2005	1		PVT	PUB	Mantonx (PPD) Aventis		Asthma/RAD ; Seasonal allergies ; positive PPD			1						1	Rash; Skin ulcer; Tenderness	FLU3~SANOFI PASTEUR~U18338A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246062	10/25/2005	CA	81.0	80		M	10/25/2005	At about 5 or 6 PM that night, pt's left arm at injection site was swollen with rash on it. Pt took 2 bufferin (325 g) and felt better. Pt had no other signs/symtoms. Had no problems sleeping. In the am, arm still swollen, tender and warm to touch. But again pt feels fine and healthy. Pt feels he does not need any further care or any treatment.									Y	10/24/2005	10/24/2005	0		OTH	OTH						1						1	Feeling hot; Injection site rash; Injection site swelling; Tenderness	FLU3~SANOFI PASTEUR~U1848AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0967P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246063	10/25/2005	KS		2	.4	M	10/25/2005	Accidental full dose (0.5ml) given instead of half dose (0.25ml) administered in RVL. Next morning, mother reports area warm to touch, swollen and red. Patient was evaluated; placed on Bactrim supervision and Orapred orally. Mother reports child fine 10/21/05.				Y					Y	10/17/2005	10/18/2005	1	NONE	PVT	PUB						1						1	Injection site erythema; Injection site swelling; Injection site warmth; Medication error	FLU3~SANOFI PASTEUR~U1756AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246068	10/25/2005	WA	76.0	76		M	10/19/2005	Swollen arm (from wrist to shoulder). Cellulitis? Levaquin 725.				Y					Y	10/12/2005	10/13/2005	1		OTH	PVT		NONE				1						1	Cellulitis; Oedema peripheral	FLU3~SANOFI PASTEUR~U1818AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0607R~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0229030	10/26/2005	TX	5.0	4		M	10/19/2005	30 Minutes after injection wheezing, shortness of breath, pale, lethargy. Gave Xopenex 1.25, EPI .15, Decadron 16mg INS  02. Information received from medical records state watering eyes, allergic reaction. msv									Y	10/19/2005	10/19/2005	0	Information from medical records states abnormal lab tests. msv	PVT	PVT	Benadryl, Propranolol	NONE	Transposition of great arteries, VSD, Vantin allergy.	~DTaP (no brand name)~5~4.00~In Patient		1						2	Dyspnoea; Hypersensitivity; Laboratory test abnormal; Lacrimal disorder; Lethargy; Pallor; Wheezing	FLU3~SANOFI PASTEUR~U1756AA~5~~LL~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0245920	10/26/2005	TN	36.0	35		F	10/26/2005	35 year old nurse had  sudden loss of peripheral vision on left while at work with some numbness in her hands and feet which had been transient since an influenza vaccine 10/11. She presented to emergency department 10/11 and was returned 10/16 for admission.   At that time she was suspected of pulmonary edema and was given Lasix.  Blood pressure and heart rate had decreased after admission. She had no headache, nausea, vomiting, dizziness.  Neurological exam was otherwise unremarkable.  CT of the head in the emergency room was negative for any acute change.  She was admitted to the hospital with diagnosis of possible scotoma from a migraine without associated headache.  MRI/MRA of head and neck obtained at the hospital were normal.  Labs were obtained for hypercoag status and were normal.  Thyroid functions were normal and she had no further visual symptom after admission.  She did have sinus bradycardia and some transient hypotension that was felt secondary to dysautonomia fro her vaccine.  She was started on Medrol Dosepak just prior to discharge 10/18.  The next day patient had tingling and heart rate of 40.  Followup appointments were made with cardiology.  Lot U1832BA -Aventis Pasteur  Fluzone, exp 6/30/06.				Y	Y	2			U	10/11/2005	10/11/2005	0		UNK	UNK		Screening questions: any illiness within past 3 days or fever > 100F?? YES (cold week prior).  All other questions checked NO as follows:  pregnant, allergic to eggs or gelatin, known hypersensitivity, sensitive to thimerosal or mercury, sensitive to latex, previous reaction such as fever, seizure or had to see MD after shot, history of seizure, brain damage, bleeding disorder, Guillain Barre, active nerve disorder or paralysis.	history of visual disturbance on left side after second child born 9-10 years ago and it was a wavy decrease in her vision at that time as well. History of asthma, takes inhalers periodically;  history of cholecystectomy, C-section;  She quit tobacco a week ago; occasional alcohol Mother has history of aneurysm clip and has had headache since the clipping			1						2	Autonomic nervous system imbalance; Heart rate irregular; Hypoaesthesia; Hypotension; Laboratory test abnormal; Migraine; Paraesthesia; Pneumonia; Pulmonary oedema; Scotoma; Sinus bradycardia; Visual disturbance; Visual field defect; Autonomic nervous system imbalance; Blood pressure decreased; Headache; Hypoaesthesia; Hypotension; Migraine; Paraesthesia; Scotoma; Sinus bradycardia; Visual field defect	FLU3~SANOFI PASTEUR~U1832BA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1832BA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0246060	10/26/2005	MT	43.0	42		F	10/25/2005	Flushing, chest tightening, SOB, feeling of impending doom, anaphylaxis tx. Benadryl, Epi, Decadron, Pepcid, Solumedrol, O2, cardiac monitoring. Information received from medical records states anxiety, dizziness. msv			Y	Y	Y				Y	10/25/2005	10/25/2005	0	NONE	PUB	PVT	Synthroid	NONE	Codeine, Darvocet, Bactrim, Amoxicillin, Keflex, Cipro, Vancomycin, Tobramycin, Prenercarl, IV dye.   Information received from medical records states hypothyroid. msv			1						1	Anaphylactic reaction; Anxiety; Chest discomfort; Dizziness; Dyspnoea; Feeling abnormal; Flushing; Hypoxia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~142BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Life Threatening,Hospitalisation	Influenza
0246064	10/26/2005	OR	90.0	89		F	10/25/2005	Vaccine administration at 11:30 am, patient having symptoms in about 20-25 min, sx: pale, light headed, confusion, dizzy, slight nausea. Treatment: place patient sitting down in a chair, monitor RR, and level of consciousness. Monitor injection site and temp. Monitored for 20 mins patient recovered and feeling better, 20 mins patient caregiver called back nausea sx returned.  Called patient PCP for advise, gave Claritin 10mg. Ammonia Tab 1540, and other visit if necessary. Called at 3.20pm patient sleeping, no sx. (follow up) Called at 7.40 PM (to patient and daughter) no RXN. Slight tenderness on arm (per MD ice and Tylenol).										10/25/2005	10/25/2005	0		OTH	PVT	UNK	NONE	NONE listed MSG (unknown if physician diagnosed) a possibility of latex allergy which was described previously.			1						1	Confusional state; Dizziness; Nausea; Pallor; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA130AB~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246065	10/26/2005	MT	45.0	44		F	10/25/2005	Local redness, generalized itching, Tx observation, ice to injection site.				Y					Y	10/25/2005	10/25/2005	0		PVT	PVT	Thyroid T3 + T4, oral contraception (low dose).					1						1	Injection site hypersensitivity; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0246066	10/26/2005	IA	78.0	78		F	10/25/2005	Infection at injection site given Cephalexin 500mg.									U	10/20/2005	10/22/2005	2		OTH	PUB		NONE				1						1	Injection site infection	FLU3~SANOFI PASTEUR~U1903AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246067	10/26/2005	OH	3.0	2	.7	M		Fever and seizure.				Y					Y	10/04/2005	10/05/2005	1	Went to ED needed Diastat CBC renal CXR Blood culture.	UNK	UNK						1						1	Convulsion; Pyrexia	FLU3~SANOFI PASTEUR~U17430A~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246080	10/26/2005	TN	1.23	1	.2	F	10/19/2005	Unknown Pt died in her sleep morning of 10/19, she did have low grade, subjective fever 10/17 and 10/18. No additional information in discharge summary rec'd 11/9/05/sr Additional information added from Autopsy report rec'd 01/11/2006: Preexisting condition -- chronic bronchitis. Patient's sibling was hospitalized for flu & fever & had full recovery & sibling's admission medical record included.  Post mortem viral c/s were neg./sr	Y	10/19/2005								10/17/2005	10/19/2005	2		PVT	UNK		Upper respiratory infection	NONE			1						1	Abnormal sleep-related event; Bronchitis; Pyrexia	FLU3~SANOFI PASTEUR~U1765EA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0246083	10/26/2005	TX	4.0	4		M	10/19/2005	Left deltoid dusky red, indurated, warm, tender, plague, fever.				Y					U	10/14/2005	10/15/2005	1	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Feeling hot; Hypersensitivity; Injection site induration; Pyrexia; Tenderness	DTAP~SANOFI PASTEUR~U1396CA~5~IM~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1761AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y02642~4~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0233R~2~IM~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0246085	10/26/2005	HI	9.0	8		M	10/18/2005	4 x 3 induration and slightly warm, itchy, erythema.									Y	10/16/2005	10/17/2005	1	NONE	PVT	PVT		NONE	NONE			1						1	Erythema; Feeling hot; Injection site induration; Pruritus	FLU3~AVENTIS PASTEUR~U1754AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246086	10/26/2005	AK	0.62	0	.6	M	10/14/2005	Patient developed papular rash on face 10/08 and spread to trunk, no rash on hands and feet. By 10/10. tactile fever on 10/11. NO further spread.									Y	10/05/2005	10/08/2005	3	NONE	OTH	PUB		NONE				1						1	Pyrexia; Rash papular	FLU3~SANOFI PASTEUR~U1754AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246087	10/26/2005	ME	64.0	63		F	09/20/2005	Approx 15 mins after receiving flu vaccine pt states left arm felt cold, fingers left hand numb, nausea, dizziness, slight headache.									Y	09/20/2005	09/20/2005	0	No treatment needed	PVT	OTH		NONE	Codeine, Dilantin.			1						1	Dizziness; Feeling cold; Headache; Hypoaesthesia; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA131BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246088	10/26/2005	CA	65.0			M	10/20/2005	Dr stated he felt tired, weak, headache, within 24 hours of receiving flu shot. Signs/symptoms now resolved. S/S lasted approximately 4 days. Did not seek treatment. Took acetaminophen only.									Y	10/13/2005	10/14/2005	1		PVT	PVT		NONE	Heart disease, Coronary Artery Disease, Hypertension, (S/P CABP 10 years ago).			1						1	Asthenia; Cardiac disorder; Coronary artery disease; Fatigue; Headache	FLU3~SANOFI PASTEUR~U1832BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246089	10/26/2005	NY	5.0	5		F	10/19/2005	Facial swelling, cough and wheezing.									Y	10/18/2005	10/18/2005	0		PVT	PUB	Flovent, Sudafed cough and cold, albuterol.	NONE	Asthma			1						1	Cough; Face oedema; Wheezing	FLU3~SANOFI PASTEUR~U1846AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246090	10/26/2005	GA	58.0	58		F	10/13/2005	Fluzone 10/10/2005, 10/11/2005 itching right hand and head, ears swollen, 10/12/2005 hives problem itches, worst head, right hand severe red swelling, 10/13/2005 left hand arm red itchy, hives worse waist and chest.										10/10/2005	10/11/2005	1		PVT	PVT		NONE	Monoclonal Gammopathy, Diabetes II			1						1	Ear disorder; Hypersensitivity; Oedema; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1819AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246091	10/26/2005	IL				U		Intra nasal flu mist given 10/17/2005. Preceptal cellulitis on left eye. Medical records state conjunctivitis. msv										10/17/2005	10/19/2005	2		PVT	PVT	NONE	NONE	Eczema			1						1	Cellulitis; Conjunctivitis	FLUN3~MEDIMMUNE VACCINES, INC.~500390P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0246092	10/26/2005	PA	32.0	32		F	10/20/2005	Received flu vaccine 10/12/2005. On 10/13/2005 Developed diffuse rash, itching and joint swelling, Evaluated by allergist on 10/17/2005 and prescribed prednisone and Atarax. Seen in Occupational health on 10/19/05 symptoms still present.				Y					N	10/12/2005	10/13/2005	1		PVT	PVT	Singulair, Zyrtec, Allegra		Allergies			1						1	Joint swelling; Pruritus; Rash	FLU3~SANOFI PASTEUR~U1804AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246093	10/26/2005	NC	56.0	56		F	10/14/2005	Pts right upper arm red, swollen and painful to touch. Also warm to the touch. Area of induration and erythema - 120 x 120mm.									Y	10/13/2005	10/13/2005	0	NONE	PUB	PVT	Levothyroxine, Benicar		Allergies, Cipro, penicillin Benadryl, Graves disease.	Difficulty swolling, N & V fever~Vaccine not specified (no brand name)~1~27.00~In Patient		1						1	Erythema; Feeling hot; Hypersensitivity; Injection site induration; Oedema; Pain	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246094	10/26/2005	CO	59.0	59		U		Eyes red on fire mattery, nose stuffy and yet runny, chills, aches heart beat slightly increased, next day weak, felt like walking on a boat unstable, felt fine by day 3.									Y	10/15/2005	10/15/2005	0		UNK	OTH						1						1	Asthenia; Balance disorder; Chills; Eye inflammation; Heart rate increased; Nasal congestion; Ocular hyperaemia; Pain; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246095	10/26/2005	WA	55.0	55		F	10/18/2005	Parasthesia starting in right hand radiating up through arm to right side of neck and face. SX developed after vaccination into right, deltoid. Resolved in 24 hrs. No TXT req'r. Currently patient had mild soreness at injection site.									Y	10/17/2005	10/17/2005	0	Breast cancer 1998 chemo in 1999. Extremely painful parasthesia in 1999 after Taxol therapy.	OTH	PVT	Femura, cymbalta, vitamins		1999 breast cancer, depression, parasthesia with Taxol, parasthesia with moderate illness	Swelling~Typhoid Vi Polysaccharide (no brand name)~~18.00~In Patient		1						1	Injection site pain; Neoplasm malignant; Paraesthesia	FLU3~SANOFI PASTEUR~U1903AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246097	10/26/2005	NV	71.0	71		F	10/10/2005	Patient received 2 vaccines Fluzone in right arm, pneumonia in left arm. She reported flu like symptoms fever, sore neck, throbbing at injection site and hardening around injection site with bruising. This subsided over a couple weeks.									Y	09/27/2005	09/28/2005	1		OTH	UNK			Lupus			1						1	Contusion; Influenza like illness; Injection site induration; Injection site reaction; Neck pain; Pyrexia	FLU3~SANOFI PASTEUR~U1811AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0790P~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246098	10/26/2005	NY	48.0	47		F	10/18/2005	Began with shortness of breath, reserve inhaler taken. Generalized red rash and itching followed. Swelling of face and eyes. Coughing began.				Y					Y	10/14/2005	10/14/2005	0		PVT	PVT		NONE	Asthma			1						1	Cough; Dyspnoea; Eye oedema; Face oedema; Hypersensitivity; Pruritus; Rash	FLU3~SANOFI PASTEUR~U1804AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246099	10/26/2005	LA	48.0	47		F	10/21/2005	Mild localized redness and swelling at injection site 7cm.				Y					Y	10/18/2005	10/18/2005	0		UNK	UNK						1						1	Injection site hypersensitivity; Injection site oedema	FLU3~SANOFI PASTEUR~U1839AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246100	10/26/2005	IA	46.0	46		M	10/21/2005	Pt received a flu injection and pneumonia injection in left deltoid the next day complained of fever, nausea, body aches and left arm with erythematous, indurated and measuring 10.0 x 5.0 C.									Y	10/03/2005	10/04/2005	1		PVT	PVT	Cialas					1						1	Erythema; Injection site induration; Nausea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1806AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0486P~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246101	10/26/2005	IA	56.0	55		M	10/21/2005	PT received a flu injection on 10/17/2005 he called the next day and said he had a temp of 101.8 all that night. it broke around 4am and was doing better.									Y	10/17/2005	10/17/2005	0	NONE	PVT	OTH	Diovan, Flucietine, levoxgl					1						1	Pyrexia	FLU3~SANOFI PASTEUR~U1830AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246102	10/26/2005	MI	45.0	45		F	10/18/2005	PVP administered 10/17/2005 Monday, approx 4 hours post injection noticed soreness and warmth entire upper arm. by evening noticed stiffness and large reddened site upper arm. Took 800mg Ibuprofen at that time. States c/o worse 10/18/2005 am, using ice to site and taking ibuprofen. Reported to me at 4:30 10/18/2005. Instructed to continue ice and ibuprofen. To come back 10/19/2005 am to recheck site. Area outlined also instructed if c/o increase to go to ER. To call Dr 10/19 am to advise him of reaction and need of further Tx. 10/19/2005 9:00am staff member returned to me to check site. Area very light pink no redness, warmth or swelling at site movement greatly improved of arm. Soreness almost completely subsided, re instructed to make PCP aware of reaction									U	10/17/2005	10/17/2005	0		OTH	PVT	Wellbutrin XL, Zoloft, Prevacid, Synthroid, Advair, Clarinex, Flonase.	NONE	Asthma, Depression, Hypothyroid, GERD			1						1	Feeling hot; Hypokinesia; Injection site hypersensitivity; Musculoskeletal stiffness; Pain	FLU3~SANOFI PASTEUR~U1846AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749P~3~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246103	10/26/2005	MA	4.0	4		M	10/17/2005	Left deltoid vaccine injection site increased swelling and pain touch.									Y	10/14/2005	10/14/2005	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U1747A~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246104	10/26/2005	WY	59.0	58		F	10/24/2005	Left arm hurt all night long on 10/17/05. On 10/18/05, had swelling, redness to elbow. Felt hot to touch and had redness. Went to ER evening of 10/18/05. Received IV antibiotics, Clindamycin, then orally.				Y					Y	10/17/2005	10/17/2005	0		PUB	PUB		NONE	NONE			1						1	Erythema; Feeling hot; Pain; Swelling	FLU3~SANOFI PASTEUR~U1807AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1039P~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246105	10/26/2005	NJ	23.0	23		F		Urticaria within 3 hours after vaccine administration right arm. Vaccine administered left deltoid IM.									Y	10/18/2005	10/18/2005	0		PVT	PVT	Zoloft/OBCP	NONE	Depression			1						1	Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA125AC~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246106	10/26/2005	NC	52.0	52		F	10/21/2005	Left arm turned red with fever and swollen near injection site; also sore to touch.									Y	10/18/2005	10/19/2005	1	NONE	PVT	PVT	Allegra	NONE	NONE			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Pain	FLU3~SANOFI PASTEUR~U1752LA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246107	10/26/2005	MI	26.0	25		F	10/20/2005	Soreness in left arm, redness and a small bump on upper arm.									Y	10/18/2005	10/20/2005	2		PVT	UNK	NONE	NONE	Shellfish			1						1	Erythema; Pain; Skin nodule	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA151AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246108	10/26/2005	MI	60.0	60		F	10/21/2005	Redness, swelling around injection site.									Y	10/18/2005	10/19/2005	1		PVT	UNK	Catapres, Prinzide	NONE	NONE			1						1	Injection site erythema; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~UA151AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246109	10/26/2005	MI	51.0	51		F	10/20/2005	Swelling at site of injection and bruising.  Warm to the touch.  Treated with Ice.									Y	10/18/2005	10/20/2005	2		PVT	UNK		No	Allergy to Mold, Dust, Trees, Dogs and Cats, Mites.			1						1	Contusion; Feeling hot; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~UA151AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246110	10/26/2005	MI	61.0	60		F	10/21/2005	Swelling, redness at injection site.  Treated with ice and tylenol.									Y	10/18/2005	10/19/2005	1	NONE	PVT	UNK	Lotrel, Tenormin, Detrol, Glucophage, Acrose	NONE	Keflex, Shellfish.			1						1	Injection site erythema; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~UA151AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246111	10/26/2005	VA	4.0	4		F	10/26/2005	2 1/2 x 2 1/2 area of induration and redness.  Minimal warmth, mild swelling in office on 10/21/2005, after ER visit.  Diagnosed with Cellulitis.  Treated with Cleocin.				Y					Y	10/19/2005	10/20/2005	1	N/A	PVT	PUB		NONE	Asthma			1						1	Cellulitis; Erythema; Feeling hot; Injection site induration; Swelling	DTAP~SANOFI PASTEUR~C2221AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1846AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1240~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0156R~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0246112	10/26/2005	MI	38.0	38		F	10/21/2005	Swelling of joints, rash, itch, swelling to lips.  Benadryl, epi-pen.									Y	10/18/2005	10/20/2005	2		PVT	UNK	NONE	NONE	NONE			1						1	Joint swelling; Pruritus; Rash; Swelling face	FLU3~GLAXOSMITHKLINE BIOLOGICALS~UA151AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246150	10/26/2005	OH	35.0	34		F	10/26/2005	Approx. 11-12 hrs. after vaccination, I noticed my leg muscles and back muscles were sore. Within the hour, I had developed a headache. During the night (15-18 hrs. after vaccination), I felt slightly feverish, appr. 100 degrees F.										10/25/2005	10/25/2005	0		UNK	UNK		none	none			1						1	Headache; Myalgia; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0246151	10/26/2005	NY	52.0	51		F	10/26/2005	On the day of immunization, patient developed local reaction with swelling, redness, warmth. Reaction resolved over next 24 hours with cold compresses, elevation, Benadryl, Claritin. Patient had received pneumococcal vaccine in 2004 but did not recall when asked.				Y					Y	10/20/2005	10/20/2005	0	None	UNK	UNK	None	None	DES exposure MVP Allergic to Augmentin			1						1	Injection site erythema; Injection site reaction; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA129AB~5~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0529P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246152	10/26/2005	NY	44.0	44		M	10/26/2005	Patient developed pain, swelling, decreased ROM right arm and temperature of 102F following immunization.				Y					Y	10/20/2005	10/20/2005	0	None	UNK	UNK	Lopressor 50 QD	None	Allergy to Penicillin Hypertension			1						1	Joint range of motion decreased; Pain; Pyrexia; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA129AB~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0579p~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246153	10/26/2005	SC	66.0	65		F	10/26/2005	Telephone call from client on 10-19-05 pm.  Stated right upper arm is very swollen, tender, red and warm to touch - RN instructed client to notify PMD.  Health Department nurse did not see local reaction.				Y					Y	10/18/2005	10/19/2005	1	NONE	UNK	UNK	NONE	NONE	NONE		SC0519	1						1	Erythema; Injection site warmth; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U1764AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1040P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246154	10/26/2005	IA	15.0	15		F	10/26/2005	UNKNOWN									U	10/25/2005				UNK	UNK	NONE	NONE	NONE			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA123AC~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246155	10/26/2005	WI	47.0	47		M	10/26/2005	Swollen tongue and lips, tight throat with coughing and wheezing.  Injection completed at approximately 1600 and reactions started about 4 hours later.  Gave two benadryl tablets which helped swelling but throat still feels tight.									Y	10/25/2005	10/25/2005	0		UNK	UNK			None			1						1	Cough; Face oedema; Throat tightness; Tongue oedema; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246157	10/26/2005	CT	79.0	79		M	10/26/2005	Flu & Pneumonia vaccine given Friday afternoon. Pt states Right arm was aching that evening (pneumonia vaccination arm).  Next morning complained of swelling and redness. Sunday morning arm was swollen, red and had a pocket of bloody fluid? below elbow.  Went to ER, was given IV antibiotics and sent home on oral medication.  Saw PCP on Monday, who reported that pt is being treated for cellulitis.  Phone call to pt 10/25, states he is improving.				Y					Y	10/21/2005	10/21/2005	0		UNK	UNK						1						1	Cellulitis; Erythema; Pain; Swelling	FLU3~SANOFI PASTEUR~U1802CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0578P~2~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246159	10/26/2005	WI	66.0	65		F	10/26/2005	Can't print pneumonia vaccine - don't know maker or name - but that was given in left arm and is cause of problem.  Sore arm shortly after injection.  Woke during night with extremely sore arm - hot to touch and felt tight.  Following afternoon had swollen, hard nodes under arm, red streak in front of axillary area (1x3), unable to raise arm without pain, extremely tender arm around injecion site and chills.  Felt lightheaded.  Slept 12 hours and awoke to less tenderness - but red streak remained. Nodes are less palpable - injection site sore but not as before.									Y	10/24/2005	10/24/2005	0		UNK	UNK	Lipitor, Zetia, Toprol XL, Amil/Hctz, Aciphex, Mobic, Climara, Aspirin, Calcium, Vit. E, Centrum Silver, Glucosamine Chondroitin with MSM	None	Allergic to Amoxicillin, Cephalexin. Cardiovascular disease.			1						1	Chills; Dizziness; Injection site pain; Injection site warmth; Lymphadenopathy; Skin striae; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246160	10/26/2005	OH	29.0	29		F	10/26/2005	On 10/19/05, pt received flu vaccine at 11 am; at noon face burning, scratchiness in throat, SOB.  Went to ER-given iv fluids, iv benadryl, iv pepcid, iv solumedrol, & sc epi .3 ml 1:1000.  Discharged with medrol dosepak, & scripts for allegra & pepcid.			Y	Y					Y	10/19/2005	10/19/2005	0		UNK	UNK			Allergies:  phenol, depo provera, go-lytely, generic aleve, tb mantoux test. Pt denies any food or egg allergies.			1						1	Dyspnoea; Pharyngolaryngeal pain; Skin burning sensation; Dyspnoea; Hypersensitivity; Pharyngolaryngeal pain; Skin burning sensation	FLU3~SANOFI PASTEUR~1773AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1773AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening	Influenza
0246161	10/26/2005	SC	68.0	68		F	10/26/2005	Redness, swelling, and heat noted in right upper arm.  Clinic RN instructed patient to follow-up with PMD.  Vaccine was given 10/18/05 and afternoon. Patient returned to clinic on 10/19/05 with arthus reaction.				Y					Y	10/18/2005	10/19/2005	1	NONE	UNK	UNK	Unknown	NONE	NONE		SC0520	1						1	Erythema; Injection site warmth; Swelling; Type III immune complex mediated reaction	FLU3~SANOFI PASTEUR~U1764AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1040P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246162	10/26/2005	MS	46.0	46		F	10/24/2005	30 minutes after receiving flu shot had nausea, bilateral leg pain, and light headedness.  Drove self to doctor.  Received phenergan and decadron IV.  S/S almost resolved immediately. Slept most of day and has been fine since.				Y					Y	10/21/2005	10/21/2005	0		UNK	UNK	None	No	None		MS0514	1						1	Dizziness; Nausea; Pain	FLU3~SANOFI PASTEUR~U1806AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246163	10/26/2005	MS	65.0	65		M	10/11/2005	Administered Pneumonia vaccine in L deltoid.  Upper left arm red, swollen and painful.									Y	10/10/2005	10/11/2005	1		UNK	UNK	Crestor Thyroxin	None	None		MS0515	1						1	Erythema; Pain; Swelling	FLU3~SANOFI PASTEUR~U1806AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246164	10/26/2005	MS	6.0	6		M	10/21/2005	Leg sore and child hopping on leg.				Y					Y	10/20/2005	10/21/2005	1	None	UNK	UNK	Breathing Treatments; Zertec	Allergy Problems with pollen	Asthma		MS0516	1						1	Gait disturbance; Pain	FLU3~SANOFI PASTEUR~U1806AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246166	10/26/2005	WA	55.0	54		M	10/26/2005	Onset of fever and chills - 6 p.m., 6 hrs. after vaccine Initial temp. taken at 7:30 p.m.: 100.7 Progressed to 103.1 at 10 p.m.  1000 mg Tylenol given at that time (10 p.m.) Temp increased to 103.6 by 10:30 p.m. Temp decreased to 103.2 at 11 p.m. 5 a.m. temp recorded at 101.6  1000 mg Tylenol given 9 a.m. temp recoded at 99.7 1000 mg Tylenol given 10:30 a.m. temp at 98.1 Still feeling weak and somewhat nauseated; headache, clammy.									Y	10/25/2005	10/25/2005	0	None	UNK	UNK	Exedrin	None	None			1						1	Chills; Cold sweat; Headache; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~Unknown~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246169	10/26/2005	FL	68.0	68		F	10/26/2005	Eyes hurt, fever throughout the night to 104F, severe headache, stiff neck, chills, shaking. Better in AM. Complete recovery by 10-26-05.									Y	10/24/2005	10/24/2005	0	None	UNK	UNK	None	No	None			1						1	Chills; Eye pain; Musculoskeletal stiffness; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~1747AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246171	10/26/2005	UT	56.0	56		M	10/26/2005	First pain/soreness in back (between shoulder blades) and a stiff neck. Then about 48 hours later multiple recurring seizures (petit mal) - almost hourly for 3 days until seizure medication (Depakote) taken.        I had not had seizures for years and had stopped taking my seizure meds earlier this year.  I had had flu shots before (while taking the seizure meds) without problems.  I still have the still back & neck but seizures are subsiding (now that I resumed my meds).				Y					U	10/21/2005	10/21/2005	0	Visited neurologist on 10/25/05 for advise.  Will have EEG tomorrow (10/26/05).	UNK	UNK	none (other than Advil, aspirin & Tylenol)	none	Allergies (hay fever) - get shots from same clinic that gave me the flu shot.			1						1	Back pain; Convulsion; Musculoskeletal stiffness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0246172	10/26/2005	MT	52.0	52		F	10/26/2005	Within 2 hours of injection patient reported to nurse that she just didn't feel good.  Has a headache, dry mouth and vision problems.  Within another half hour stated It feels like I took a draw on a toke.  Reported on 102605 at 0910 that the headache wasn't gone until Sunday, but I have a history of headaches.  Stated the other symptoms were gone by later that evening after injection.									Y	10/21/2005	10/21/2005	0	NA	UNK	UNK	None	None.				1						1	Dry mouth; Headache; Malaise; Visual disturbance	FLU3~SANOFI PASTEUR~U1764AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246175	10/26/2005	KS	47.0	46		F	10/26/2005	Fever and flu type symptoms, aches,  sore throat,  difficulty swallowing & breathing, swelling up of throat, face, and eyes, mucus pouring out of eyes, chills.									Y	10/17/2005	10/17/2005	0		UNK	UNK	Levoxyl, Straterra	None	Penicillin, Cephalosporins, Erythromycin			1						1	Chills; Dysphagia; Dyspnoea; Eye discharge; Eye oedema; Face oedema; Influenza like illness; Pain; Pharyngeal oedema; Pharyngolaryngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246188	10/26/2005	NY	44.0	44		M	10/26/2005	Left arm slightly red, swollen and warm to the touch, localized reaction.				Y						10/25/2005	10/25/2005	0		PVT	PVT		Alpha 1 antitrypsin deficiency, sinusitis (recurrent).				1						1	Injection site hypersensitivity; Injection site oedema	FLU3~SANOFI PASTEUR~U1824AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0578P~1~IM~LL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246189	10/26/2005	FL	34.0	33		F	10/26/2005	Left eye upper eyelid swelled shut upon awakening at 06:00 10/26/2005. Vaccine given approx 15:00 10/25/2005. Treated with warm compress and ibuprofen.									Y	10/25/2005	10/26/2005	1		PUB	PVT	NONE	NONE	allergic Sulfa			1						1	Eyelid oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA145AA~1~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246190	10/26/2005	IL	51.0	50		F	10/26/2005	36 hours post injection, rash, itching started, 48 hours post injection, full body hives with itching, denied dyspnea, dysphagia, shortness of breath, respiratory problems. No relief with Benadryl PO, given Medrol dose pack with decreased symptoms.				Y					Y	10/18/2005	10/19/2005	1	NONE	PVT	PVT	Depo Provera, NSAID, Norvasc, Arthrotec	NONE	No allergies, hypertension, non insulin dependent diabetes mellitus, osteoarthritis			1						1	Pruritus; Rash; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA125AC~1~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0246191	10/26/2005	MI	45.0	44		F	10/20/2005	H/o pain, redness, induration with in 24 hours. Pt examined 72 hours later ecchymosis 2cm x 10 cm area reticulated erythema.				Y					Y	10/14/2005	10/15/2005	1		PVT	UNK						1						1	Ecchymosis; Erythema; Hypersensitivity; Injection site induration; Pain	FLU3~SANOFI PASTEUR~U1763AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0240171	10/27/2005	MI	52.0	51		M	10/20/2005	After flu shot, Rt upper arm pain and weakness. Tendon reflexes absent. Loss of sensation (pin, touch, temperature). Skin warm, hot and mildly engorged. Circumference R>L by one inch. Biceps tender to palpation. NSAIDS did not resolve it. Progressed to Rt chest including swelling and temp changes.								Y	N	10/27/2003	10/27/2003	0	Rheumatology possible RSD. Mammogram negative. 09/01/04 MRI and tendinosis, bursitis impaigement by tip of acconiom bone flow, Venogram and lymphoscintigraphy all negative biopsy pending.	OTH	OTH		Diabetes	S/P Talonavicular arthodesis Left allergies tolectin, Iodine, Traniedol and celeco xib.			1						2	Abdominal pain upper; Asthenia; Hyporeflexia; Immune system disorder; Laboratory test abnormal; Oedema; Pain; Radiculitis brachial; Skin discolouration; Swelling; Asthenia; Bursitis; Feeling hot; Hyporeflexia; Injection site pain; Muscle twitching; Oedema; Osteoporosis; Pain; Pyrexia; Sensory disturbance; Tenderness; Tendonitis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1139AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Disabling	Influenza
0246186	10/27/2005	CO	53.0	52		F	10/26/2005	Hives 4 days later. PO antihistamines.									Y	10/17/2005	10/21/2005	4		PUB	UNK	Levoxyl; Glucophage; Glucotrol; Accupril; Lipitor	NONE	Hypothyroid; Diabetes			1						1	Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA129AB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246187	10/27/2005	PA	54.0	54		F	10/26/2005	10/11/05 Swelling, bruising, tender to touch at injection site. Temp 100.6 on 10/12/05. Ice, Tylenol. 10/13/05 Right upper arm moderately swollen, slightly tender. Take Mobic; continue Tylenol.				Y					Y	10/10/2005	10/11/2005	1	NONE	PVT	PVT	Humira; Nexium; Desyrel; Methotrexate; Menest; Folic Acid; Mobic; Allegra	Left OM - Augmentin started.	RA; Sjogren's Syndrome.			1						1	Contusion; Injection site swelling; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~U1792AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0619P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246205	10/27/2005	IL	64.0	64		M	10/20/2005	Pt received influenzae vaccination at drug store. 1 day after developed headache followed by paraesthesias of hands and feet. Then progressive weakness of legs and arms. Information from 60 day follow-up report states: I did not treat him after diagnosis. Per follow up: patient was evaluated on 10/19/05 and diagnosed with Guillain Barre syndrome. The reported receiving an influenza vaccination approx 1 week before the visit. Symptoms of headache and stiff neck began the day following the vaccination followed by paresthesis of all 4 extremities and progressive weakness. Pt was admitted to hospital, under the care of different neurologists. I do not have further information at this time.   1/25/06 Hospital medical records received for 10/19-10/27/2005. FINAL DX: Guillain-Barre syndrome; type 2 diabetes mellitus; hypertension Records reveal patient experienced HA, neck stiffness, numbness of feet, increased warmth of hands, eye pain & generalized weakness x approx 1 wk.  Had developed myalgias & achiness almost immediately s/p flu shot that progressed to numbness & tingling of fingers/toes,loss of taste, LBP,  & balance difficulty.  Neuro, Nephro, Pulmo consult done, admitted to ICU, tx w/IVIG, improved.  D/C to inpatient rehab					Y	9			U	10/12/2005	10/12/2005	0	Evaluated 10/19/05 clinical exam consistent with Guillain Barre syndrome EMG or 10/19/05 severe demyelinating peripheral neuropathy consistent with Guillain Barre. Pt was admitted to hospital.   Medical records state LABS: CSF: glucose 106(H), protein 205(H), c/s neg.  MRI brain WNL except for small vessel ischemic changes.  Swallow study WNL.  Hyponatremia, abnormal CSF.	UNK	UNK			Type 2 diabetes. Medical records state benign Prostatic Hypertrophy, depression GERD and allergy: sulfa.			1						1	Asthenia; CSF test abnormal; Guillain-Barre syndrome; Headache; Hypoaesthesia; Insomnia; Musculoskeletal stiffness; Paraesthesia	FLU3~AVENTIS PASTEUR~1793AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0246207	10/27/2005	TX	4.0	4		M	10/19/2005	Per mom, evening of vaccine, soreness to arm. Approximately 30 hours later, notable heat, redness and swelling. To ER; instructed to see PCP.				Y					U	10/17/2005	10/17/2005	0		PVT	PVT		NONE	NONE			1						1	Erythema; Feeling hot; Pain; Swelling	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AAC21B028AA~UNK~IM~LA~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1756AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0154R~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0246208	10/27/2005	TX	40.0	39		F	10/10/2005	Received flu vaccine during employee flu clinic on Wednesday, 10/5/05. States are sore/hurting afterwards. On Sunday 10/9, after waking, noticed arm red and swollen from shoulder to elbow on underside of arm. States injection given in lower portion of deltoid.									Y	10/05/2005	10/09/2005	4	NONE	PUB	PUB	Spiralactone	NONE	PCN; Sulfa allergies; HTN		TX05092	1						1	Erythema; Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~U1803AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246209	10/27/2005	WA	52.0	52		F	10/07/2005	Local reaction - 9cmx11cm warm, red, tender, swollen, indurated area, myalgias, chills, headache. Treatment - warm compress, Keflex 500mg QID for 10 days.				Y						10/04/2005	10/05/2005	1		PVT	PVT	Tamoxifen; Miacalcin	NONE	Sulfa; Breast cancer; Osteopenia; Kidney stones			1						1	Chills; Headache; Injection site erythema; Injection site induration; Injection site reaction; Injection site swelling; Injection site warmth; Myalgia; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA127AB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0790P~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246210	10/27/2005	TX		40		F	10/14/2005	Redness spread all over upper torso - rash spread from one breast up to top of head. Rash appeared on arms as raised, red bumps. VS: 144/82, 64, 20, 98.6.									Y	10/11/2005	10/11/2005	0		PUB	PVT	Methylin; Diovan	NONE	Hypertension			1						1	Erythema; Rash erythematous	FLU3~SANOFI PASTEUR~U1839AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246211	10/27/2005	TX	69.0	68		F	10/21/2005	Within 24 hours of administration, area left upper arm was swollen and angry red, size was about 6 inches in length and 2.5 inches in height. Occurred about 1.5 fingers breadth below injection site. Had mild headache and relieved by taking ibuprofen 1 time.									Y	10/14/2005	10/15/2005	1	NONE	PVT	PVT	Fosamax; Synthroid; Lipitor	NONE	Medications allergic to: Ceclor, Sulfa; Mg, Lodine.			1						1	Headache; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U1803AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246212	10/27/2005	WA	71.0	71		F	10/17/2005	Patient developed cellulitis on next day after injection over left forearm. Resolved nicely on antibiotics (oral).				Y					Y	10/11/2005	10/12/2005	1		OTH	UNK		NONE	NONE		WA052125	1						1	Cellulitis	FLUX~UNKNOWN MANUFACTURER~U1771AA~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0791P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246213	10/27/2005	CA	64.0	64		F	10/24/2005	Vaccination Saturday 10/15/05 at 12:35 PM. Next day, left arm was swollen and red. Legs and back pain, tired all day. Monday, 10/17/05, arm still swollen, no redness. Back a little sore.									Y	10/15/2005	10/16/2005	1		PVT	UNK	Vitamins E, C, B6; Lovastatin; Tamoxifen; Guaifenpse; Albuterol; Quar; Flonase	NONE	Asthma; Cholesterol			1						1	Back pain; Erythema; Fatigue; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246214	10/27/2005	OR	75.0	75		M	10/18/2005	Approximately 36 hours after influenza vaccination, patient called complaining of itchy raised areas over body - right. Doctor advised temporarily Ketoconazole. Patient took Benadryl and rash subsided.									Y	10/06/2005	10/07/2005	1	NONE	OTH	PUB	Ketoconazole	Prostate cancer	NONE	Same as above~Influenza (Seasonal) (no brand name)~~74.00~In Patient		1						1	Pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~U1811AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246234	10/27/2005	VT	3.0	2	.8	F	10/27/2005	C/O itchy, red, round knot on arm in area of PCV 7 injection.									Y	10/25/2005	10/26/2005	1		PVT	PUB						1						1	Injection site hypersensitivity; Injection site induration; Injection site reaction; Pruritus	FLU3~SANOFI PASTEUR~U1804AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A56117K~4~IM~RA~PNEUMO (PREVNAR)~1	USA		Influenza
0246235	10/27/2005	CA	65.0	64		M	10/27/2005	Inj 10/06/2005 48 hours past right deltoid injection site developed slight pain, then paresthesia over arm to hand, tingling, electric shock like sensation of weakness. On 10/27 still intermittent tingling.									N	10/06/2005	10/07/2005	1	NONE	UNK	UNK			high cholesterol, high blood pressure			1						1	Asthenia; Injection site pain; Paraesthesia	FLU3~SANOFI PASTEUR~U1828AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246236	10/27/2005	CA	44.0	44		F	10/20/2005	Soreness x 2 days after Pneumococcal injection on right side of neck down to right arm deltoid area.									U	10/18/2005	10/18/2005	0		PVT	PUB		Right neck and deltoid soreness				1						1	Pain	FLU3~SANOFI PASTEUR~U1810AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246240	10/27/2005	OK	42.0	41		F	10/27/2005	Muscles in upper left arm began hurting slightly within ten minutes of vaccine.  Then, pain increased steadily.  By four hours after the vaccine my arm was virtually paralyzed.  I was in extreme pain and totally unable to move my left arm.  Took Benadryl and 600 mg. of Tylenol at that time.  Some motion was returned to arm within ten minutes of taking Benadryl.									U	10/26/2005	10/26/2005	0		UNK	UNK	Llvoxyl 50 mcg, Cytomel 25 mcg	None	Have a reaction to ascorbic acid so cannot have any citrus food like oranges, lemons, limes or grapefruit.  Also allergic to mold.  Have Hashimoto's thyrodis.			1						1	Hypokinesia; Myalgia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246241	10/27/2005	MA	27.0	27		F	10/27/2005	Pruritic rash with signs of early anaphylaxis. Symptoms occurred 5 hours after vaccine administered.				Y					Y	10/26/2005	10/26/2005	0		UNK	UNK						1						1	Anaphylactic reaction; Rash pruritic	FLU3~SANOFI PASTEUR~61824aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246243	10/27/2005	FL	43.0	43		M	10/27/2005	Pt woke me up about 11:30 pm and it scared me because I did not recognize his voice. He sounded extremly hoarse, he was very pale, skin was cold and clammy and wheezing. He said he was having much trouble breathing (getting his breath). I called the emergency dept. and spoke with them relayed Pt's symptoms and I asked if this was a reaction to the flu vaccine I was told they did not think so that any symptoms occurred 10 to 12 hours after the shot. We then made the pt as comfortable as possible and it seemed to start to give him some sort of ease. About two this morning he finally dosed off into a fitful sleep this was on and off for the rest of the night, extreme chills, sweats, nausea persisted. This morning he was still having the occasional chill, very weak, lightheaded, and the breathing problem was much better but uneasy feeling was still here. His eyes are very red, his skin is a little pale and his head hurts. He states he still feels nothing like he did last night. The pt is a owner operator and we had to cancel todays load and Friday's load. It is impossible to drive in this condition. I called and was told to fill this form out.			Y					Y	U	10/26/2005	10/26/2005	0		UNK	UNK	None	None	None			1						1	Asthenia; Chills; Cold sweat; Dizziness; Dysphonia; Dyspnoea; Feeling cold; Headache; Hyperhidrosis; Insomnia; Nausea; Ocular hyperaemia; Pallor; Wheezing	FLU3~SANOFI PASTEUR~41771AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Disabling	Influenza
0246244	10/27/2005	NY	54.0	54		M	10/27/2005	7X4.5 cm lump left deltoid. C/O diarrhea and nausea x 36 hours.									Y	10/24/2005	10/25/2005	1		UNK	UNK	metoprol omeprazole aspirin lipitor advair albuterol elavil	no illness	plavix-pruritis			1						1	Diarrhoea; Injection site mass; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua139aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246245	10/27/2005	NY	78.0	77		F	10/27/2005	10/25/2005 - Received telephone call from patient reporting that on Friday evening (10/21/05) her right arm become red, hot and painful at the injection site down to the elbow.  Patient called her doctor, and MD adviced her to take Clindamycin 150mg. Received Pneumococcal vaccine on the right arm.  Started feeling chills after receiving it.									Y	10/21/2005	10/21/2005	0		UNK	UNK		N/A				1						1	Chills; Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U1904AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0055R~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246248	10/27/2005	SC	73.0	72		F	10/27/2005	Severe erythema at site of injection (right upper arm) with edema and tenderness.  Applied cold pack and took 2 Tylenol ; next am redness lessened but extended over larger area with tenderness into inner aspect of upper arm.  Advised to continue cold occasionally and OTC anti-inflammatory as directed on package and if signs and symptoms were not relieved, to see PMD or ER.									Y	10/20/2005	10/20/2005	0	NONE	UNK	UNK	Synthroid, Vitamins E and C	NONE	Allergies: dogs, mold, mildew, fragrances, bleach. Conditions: diverticulitis, sinus, thyroid disease		SC0521	1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U1819AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0346R~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246249	10/27/2005	MI	37.0	36		F	10/27/2005	Difficulty taking a complete deep inhalation, hoarseness, coughing, chest and throat tightness. Onset 2.5 hours after vaccination, lasting 3 hours.  Similar simptoms when exposed to cat dander, however this experience was more severe.  Recovered on own, however had thoughts of having to go to ER, a place I've never been.									Y	10/26/2005	10/26/2005	0	None completed.	UNK	UNK	none	none	Seasonal allergies Cat & Dog allergies Sulfa drug allergies No food allergies			1						1	Chest discomfort; Cough; Dysphonia; Dyspnoea; Throat tightness	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246250	10/27/2005	GA	63.0	62		F	10/27/2005	Within 5 minutes after Fluzone influenza vaccine administration on 10/26/05 at about 8:50pm, patient reported a tingling sensation in her right ear and right side of face.  She explained that this has happened before on 2 other occasions after administration of influenza vaccinations.  She further explained that the right side of her face, head, & neck went numb for several hours on the previous occasions.  She also said that once she did not have this reaction after an influenza vaccination.  She did not report any breathing difficulty or the like type of allergic reactions. Because of the 2 previous occurences, she was not concerned about this reaction, and after about 15 minutes she left with her husband.  She also mentioned that her 1st cousin (blood relative) also had this same reaction after an influenze vaccination once.  Patient also mentioned that she wanted the vacccination in her right arm because she had a left breast mastectomy.  Patient said that her doctor also witnessed this reaction during one of her previous influenza vaccinations.									Y	10/26/2005	10/26/2005	0	N/A	UNK	UNK	unknown	none	left breast mastectomy	right side head, face, neck tingling then numbness for several hours~Influenza (Seasonal) (Fluzone)~3~0.00~In Patient		1						1	Ear disorder; Hypoaesthesia; Paraesthesia	FLU3~SANOFI PASTEUR~U1826AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246251	10/27/2005	NC	0.17	0	.2	F	10/27/2005	no adverse effect- no tx given.									Y	10/26/2005	10/26/2005	0	N/A	UNK	UNK	N/A	None	None			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U1831AB~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246252	10/27/2005	LA	43.0	42		F	10/27/2005	Local irritation and pruritis at injection site, left deltoid.  No respiratory compromise.  Denies other symptoms.  Benadryl given po.									U	10/23/2005	10/25/2005	2	None.	UNK	UNK	hctz 25mg	denies	HTN, treated occasionally (patient admits missing doses)			1						1	Injection site reaction; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua127bb~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246253	10/27/2005	CA	57.0	56		F	10/27/2005	Approximately 3.5 hours after flu shot I began to experience extreme fluid build-up in my chest.  began coughing, then fluid is pouring out my nose and mouth.  began to have rapid heartbeat, claminess, difficulty swallowing, confusion.  In 20 minutes it went from gad to worse.  I grabbed a cold cup of coffee while I was on the phone with the nurse.  within a few minutes of drinking the coffee I was able to breath without difficulty.  went to clinic.  diagnosed as severe reaction.  blood pressure was low and temperature was 101.  Information received from medical records includes neausea, runny nose.			Y							10/26/2005	10/26/2005	0		UNK	UNK	none	none	none Information received from medical records states tobacco dependance. msv			1						1	Chest pain; Cold sweat; Confusional state; Cough; Dysphagia; Hypotension; Nausea; Pyrexia; Rhinitis; Tachycardia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0246254	10/27/2005	IN	57.0	57		F	10/27/2005	Redness and swelling at site.  Half dollar size.									Y	10/26/2005	10/26/2005	0		PUB	UNK	Darvocet, Hydrocodone, Elavil, Ultram, Welcchol, Xanax, Glucophage, Estress, Zitia and Tricor	Stated to be well	Gall bladder Surgery, Hysterectomy, Lymphoma			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U1764AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246257	10/27/2005	CA	54.0	53		F	10/27/2005	Itching and hives at the injection site 24 hours post injection.  Have not had treatment--was instructed to fill out this form to report.  I'm going to assume that I will recover :)									Y	10/26/2005	10/27/2005	1	none	UNK	UNK	none	none	none			1						1	Injection site reaction; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1828AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246258	10/27/2005	WA	63.0	62		F	10/27/2005	5 days after receiving flu vaccine my wife developed the onset of erythema nodosum like lesions on her right arm and pretibial areas. There were also a few lesions on her face. After 10 days or so they have begun to clear but are still present 20 days after the shot. There was surrounding erythema and some pruritis. I also took a digital picture of the lesions on the pretibial area.									Y	10/07/2005	10/12/2005	5		UNK	UNK	vitamins only	none	in good health			1						1	Erythema nodosum; Pruritus; Skin ulcer	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246259	10/27/2005	OH	78.0	77		M	10/27/2005	Influenza vaccine administered in right deltoid. 2 days later, patient's arm became black and blue and sore, unable to lift over head. Visit to MD office - reported that his MD speculated that an artery had been hit during adminstration. No blood was in syringe when plunger withdrawn during adminstation.				Y					Y	10/17/2005	10/19/2005	2		UNK	UNK			Diabetes			1						1	Contusion; Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U1777AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246261	10/27/2005	IN	44.0	43		F	10/27/2005	Pt experience pain radiating  down left arm for 2 weeks after flu vaccine was administered. She recieved a course of Prednisone and was doing better.				Y					Y	10/14/2005	10/14/2005	0		UNK	UNK		none	erythomycin, minocylin, macordatin allergies hxof migraines and allergiec rhinnits			1						1	Pain	FLU3~SANOFI PASTEUR~U1761AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0245507	10/28/2005	TX	24.0	23		F	10/25/2005	Initial case received from a health care provider on Oct 17 2005. A 23 year old female received a left deltoid injection of Fluzone SV 2005-2006 USP, lot number U1744AA, on Oct 13 2005. On day later in the pm when she went to work, she complained of a rash at the injection site, neck and ankles. She was examined in an ER where she was diagnosed with thrombocytopenia purpura and admitted to the intensive care unit. Per the reporter, she remains hospitalized. Relevant laboratory test were not reported. The patient had received previous doses of Fluzone although adverse events to prior vaccinations were not reported. Pre existing medical conditions were not known. Information regarding other medication were not reported. Illness at the time of vaccination was none. At the time of this report, the patients recovery status was unknown.					Y				U	10/13/2005	10/14/2005	1	Laboratory data was not reported.	UNK	UNK			The pt had no illness at the time of vaccination. Pre-existing medical conditions were not known. Information regarding other medications were not reported.		200502115	1						2	Anaemia; Aspartate aminotransferase increased; Cardiomegaly; Ecchymosis; Eye haemorrhage; Haematemesis; Haematuria; Haemoptysis; Headache; Influenza like illness; Injection site rash; Laboratory test abnormal; Malaise; Mental impairment; Nausea; Oedema peripheral; Pulmonary oedema; Rash; Thrombocytopenia; Vascular anomaly; Vomiting; Injection site rash; Rash; Thrombocytopenic purpura	FLU3~SANOFI PASTEUR~U1744AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1744AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0246262	10/28/2005	PA	3.0	2	.7	U	10/26/2005	A two year old pt with no preexisting medical history or illness, had received a first injection of Fluzone sv 2005-2006 usp, lot number U41753AA on 10Oct05. The route/site of admin were not reported. Two days later the pt developed generalized urticaria throughout the entire body. The pt was seen by a physician and was treated with a antihistamine and a steroid. His/her condition is improving but still persists at the time of this report.				Y					N	10/10/2005	10/12/2005	2		PVT	PVT			There were no illnesses, no known allergies, no use of other medications or pre-existing conditions at the time of vaccination.		200502130	1						1	Urticaria	FLU3~SANOFI PASTEUR~U41753AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246267	10/28/2005	NY	82.0	81		M	10/21/2005	Initial report received from a consumer on 10/11/2005.It was reported from another company that a consumer informed them that her 81 year old father developed hives, angioedema of the lips, thumbs, testicles and had a severe rash on his back after receiving the injection of Fluzone, lot number U1773AA in the left deltoid on Oct 10 2005. The patient has received flu shots in the past and has never had a reaction. He does not have an allergy to eggs. Immunization was received at 14.00 hours and by 18.00 hours he was complaining of being itchy. He then broke out in hives, had angioedema of the lips, thumb and testicles. He went to the emergency department and was treated with Prednisone and Benadryl. At the time of this report the patient states he is still on the medication but the symptoms were much better. (OMIC)				Y						10/10/2005	10/10/2005	0		UNK	UNK			The patient has received flu shots in the past and has never had a reaction. He does not have an allergy to eggs.		200502075	1						1	Angioneurotic oedema; Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U1773AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246268	10/28/2005	CA	55.0	55		F	10/21/2005	A 55 yr old female with a medical history of rheumatoid arthritis received an injection of Fluzone SV 2005 2005 USP, lot number U1745AA, on 14Oct05. The route and site of vaccination were not reported. Within 45 minutes, she complained of tightness and a strange feeling in her throat. The pt also vomited. Per the reporter, the pt has had annual previous doses of Fluzone. There was no information regarding adverse events related to prior vaccinations. She denied illness at the time of vaccination and had no known allergies. The pt takes the medications Remicade, Fosamax, Methotrexate, Prednisone, Indocin and Folic acid. At the time of this report, the pt had not recovered. This case is linked to case number 200502114. (OMIC)				Y					N	10/14/2005	10/14/2005	0	Relevant diagnostic and laboratory test were listed as N/A per the reporter.	UNK	UNK	Folic acid, Fosamax, Indocin, Methotrexate, Prednisone, Remicade		The patient has a history of rheumatoid arthritis and is on the medications Folic acid, Fosamax, Indocin, Methotrexate, Prednisone, Remicade. the patient has received previous doses of Fluzone annually although the exact number of previous doses was not reported. Adverse events to previous vaccination were not reported. The patient denied illness at the time of vaccination and has no known allergies.		200502113	1						1	Throat tightness; Vomiting	FLU3~SANOFI PASTEUR~U1745AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246271	10/28/2005	DC	7.0	6		M	10/24/2005	Developed swollen left elbow 10/17/05 had sore neck and headache day prior. Presented with swollen left elbow and subsequent weakness 10/17 and subsequently developed HSP. Hospitalized x 24 hrs, sent home and readmitted x 5d.  12/22/05 Review of 9-page d/c summary for admission of 10/19/05. D/C diagnosis was Henoch-Schonlein Purpura.  12/22/05 Review of 8-page d/c summary for admission of 10/24/05. D/C diagnoses were viral gastroenteritis and likely Henoch Schonlein Purpura. Symptoms included vomiting, abdominal pain, sore throat, dehydration, and increase in petechial rash. Joints were still swollen.				Y	Y	5	Y		Y	10/13/2005	10/16/2005	3	At hospital, full work up.	PVT	PVT	Fovadil, Flovent 110 2p BID	NONE	10/22/05 Per review of d/c summary asthma was pre-existing.			1						1	Asthenia; Dehydration; Gastroenteritis; Headache; Henoch-Schonlein purpura; Joint swelling; Neck pain; Oedema; Pharyngitis; Viral infection	FLU3~SANOFI PASTEUR~U1746AA~6~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0246273	10/28/2005	TX	60.0	59		U		Chills, fever, chest congestion, ear ache, nasal congestion, immediate within 4 hours.										10/18/2005	10/18/2005	0		OTH	PVT		NONE				1						1	Chills; Ear pain; Nasal congestion; Pyrexia	FLU3~SANOFI PASTEUR~C01793A~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246275	10/28/2005	MI		67		F	10/27/2005	Swelling of left arm pneumonia shot, T 101.0, red, swelling from shoulder to elbow within a few days.				Y						10/25/2005	10/25/2005	0		OTH	PVT	Lipitor, Fosamax		Emphysema, high cholesterol.			1						1	Injection site hypersensitivity; Injection site oedema; Injection site reaction; Pyrexia	FLU3~SANOFI PASTEUR~U1792~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1006P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246276	10/28/2005	MA	6.0			M	10/25/2005	Generalized pruritus, flushing, cough, bronchospasm within 3-4 minutes after admin of 0.5cc Influenza vaccine. Epi Pen Jr, Benadryl 24mg PO, Albuterol by neb led to improvement over 1 hour.				Y					Y	10/24/2005	10/24/2005	0	Patient known to be allergic to gelatin because of allergist evaluation after anaphylaxis to MMR vaccine #2 at age 5 yrs.	PVT	PUB	Albuterol for recent asthma attack	Recovering from asthma attack	Patient known to be allergic to gelatin because of allergist evaluation after anaphylaxis to MMR vaccine #2 at age 5 yrs, also congenital blindness 2 ROP	anaphylaxis~Measles + Mumps + Rubella (no brand name)~2~5.00~In Patient		1						1	Bronchospasm; Cough; Flushing; Pruritus	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246277	10/28/2005	CO	1.05	1	.1	M	10/24/2005	Patient had swollen eyes, red cheeks and fleeting/evanescent urticaria on face.									Y	10/24/2005	10/24/2005	0		PVT	PVT			Amoxicillan - hives	Urticaria~Vaccine not specified (no brand name)~1~1.00~In Patient		1						1	Erythema; Eye swelling; Urticaria	FLU3~SANOFI PASTEUR~U1743NA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X0459~3~~RL~POLIO VIRUS, INACT. (POLIOVAX)~1|VARCEL~MERCK & CO. INC.~0648P~1~~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0246278	10/28/2005	PA	15.0	14		F	10/23/2005	Blank									Y	10/22/2005	10/22/2005	0		OTH	PUB			Allergy: dust, pollen. ADD. Questionable Marfans Syndrome			1						1	Vaccination failure	FLU3~SANOFI PASTEUR~U1804AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246279	10/28/2005	ND	45.0	44		F	10/24/2005	I've never had adverse reaction to Flu shots. I've had before sneezing practically right away and then my nose started running. By evening I developed the worse cough I've ever had. Bronchial system all clogged up. Left ear seems stuffed up as it's harder to hear out of than usual. Woke up that next morning and my mouth and tongue had a coating. Had bad body chills for about a day and a half. Stuffed up and runny nose. No thermometer to take my temp. I'm taking Equalinetussin cough and chest, congestion DM cough syrup and Equaline allergy tablets antihistamine that my mother brough over as I am too sick to go anywhere.									N	10/15/2005	10/15/2005	0		OTH	OTH						1						1	Cough; Nasal congestion; Rhinorrhoea; Sneezing	FLU3~SANOFI PASTEUR~AFLUA138BA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246280	10/28/2005	WI	3.0	3		M	10/20/2005	Swelling of left thigh									U	10/17/2005	10/19/2005	2		OTH	PUB	Flovent, Albutrol		asthma			1						1	Swelling	FLU3~SANOFI PASTEUR~U1805AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246281	10/28/2005	NJ	30.0	30		M	10/21/2005	Reports feeling dizziness, unable to focus, voice hoarseness, trembling,  O2 15L by nonresreather mask then nasal O2 at 2L/min.									Y	10/21/2005	10/21/2005	0	None/ Clinical exam revealed granulation & erythema pharynx	OTH	PVT	NONE	NONE	NONE			1						1	Dizziness; Dysphonia; Erythema; Eye disorder; Tremor	FLU3~SANOFI PASTEUR~U1810AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246282	10/28/2005	MA	0.52	0	.5	M	10/24/2005	Immediately after receiving flu vaccine, Hib, Prevnar, Pediarix (Ibuprofen 50mg) developed body wide hives, no wheezing, no stridor. (had received Hib/Previnar/Pediarix & Ibuprofen @ 4 mo. no problems).				Y					Y	10/24/2005	10/24/2005	0	NONE	PVT	PUB	Ibuprofen	NONE	NONE			1						1	Urticaria	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A018AA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U788BA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE573AA~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~U1788BA~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0246283	10/28/2005	GA	72.0	71		M	10/21/2005	Patient got immun. at 1:pm at 7:00pm c/o extreme soreness under same arm. Pneumonia vaccine was administered by 11:00pm c/o fever/chills, had trouble sleeping due to soreness. Feels better today but arm still extremely sore.									Y	10/20/2005	10/20/2005	0	NONE	PUB	UNK		NONE				1						1	Injection site pain; Pyrexia; Sleep disorder	FLU3~SANOFI PASTEUR~U1904AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246284	10/28/2005	NE				U	10/11/2005	Erythema facial (erythema) Nasal congestion MEDI-0003701 is non serious spontaneous case from a physician in the USA involving Redness around the nose: (unlabelled, USA). The reporter causality is not provided to FluMist. This case is submitted according to the VAERS Safety Surveillance accelerated reporting agreement for FluMist. A physician from a pediatric clinic reported that a child received FluMist in 2004 and later in the day experienced nasal congestion and redness around the nose. The patient completely recovered. No other information is available. The reporter causality is not provided. Information received 6-23-2006 states Vaccine was administered at facility; patient was only seen once.									Y					PVT	OTH	Concomitant drug(s) not reported				MEDI00037010	1						1	Erythema; Nasal congestion	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0246285	10/28/2005	KY	7.0	7		F	10/24/2005	Mom called to report that pt rec'd Flumist 2 days ago- now has chills, body aches, runny nose.									U	10/21/2005	10/23/2005	2		PVT	PVT		NONE	NONE			1						1	Chills; Pain; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500390P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0246308	10/28/2005	MD	52.0	51		M	10/28/2005	51 yo M admitted with chest pain and shortness of breath, given influenzae vaccine at 1000 on 10/25/05.  approximately 12 hours later pt developed fever of 103.5 and cellulitis at site of injection.  Pneumococcal vaccine was administered at the same time - it is unclear if the two vaccines were gven at the same site and/or mixed together.  Pt was treated with intravenous cefazolin and vancomycin for cellulitis.  72 hours after onset, area is still hot, red and swollen although pt reports it feels better.  Temperature declining. 11/14/05 - Per review of d/c summary cellulitis confirmed. Orthopnea was noted.							Y		U	10/25/2005	10/25/2005	0	blood culture negative to date, wbc increased from 7.8 before vaccine to 17.6 (24 hours after vaccine)	UNK	UNK	aspirin 325mg po qday, clopidogrel 75mg po qday, metoprolol 50mg po q12h, pravastatin 40 mg po qhs	chest pain and shortness of breath 11/14/05 Per review of medical records add throat tightness.	pt reports receiving the flu vaccine 2 years ago without any problem.  no known drug allergies and no history of adverse events with vaccines. 11/14/05 Per review of medical records hyperlipidemia, asthma, back pain, and weight gain were pre-existing conditions.			1						1	Cellulitis; Chest pain; Injection site erythema; Injection site reaction; Injection site swelling; Injection site warmth; Orthopnoea; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua151ba~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~PFIZER\WYETH~0605r~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA	Hospitalisation	Influenza
0246309	10/28/2005	VA	46.0	45		F	10/28/2005	Left arm red and bruised at site of injection.  Soreness noted.									U	10/26/2005	10/27/2005	1		UNK	UNK	b/p med and vitamin	None	None			1						1	Contusion; Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U1831AB~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246311	10/28/2005	MD	80.0			M	10/28/2005	80 yo M receiving chemotherapy in outpt cancer center was given influenzae vaccine at 1330 and approximately one hour later pt developed shortness of breath, rales in lungs, and tightness in throat.  pt transferred to emergency room and subsequently intubated and transferred to intensive care unit.  Pt treated with methylprednisolone and furosemide inj.			Y	Y			Y		U	10/27/2005	10/27/2005	0	wbc = 14.7, troponin T went from 0.5 to 2.8, echo normal	UNK	UNK	docetaxel, carboplatin, darbepoetin, palonosetron	lung cancer				1						1	Dyspnoea; Rales; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua151ba~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Life Threatening,Hospitalisation	Influenza
0246312	10/28/2005	OH	17.0	17		M	10/25/2005	Cellulitis at injection site with temperature to 104 F. and vomiting.  No other signs of infection.  Admitted to hospital treated with IV antibiotics starting with Ancef, no significant clinical improvement at site, so antibiotics changed clindamycin, no improvement so changed to zosyn and vancomycin.  Admitted 10/21/05, discharged 10/24/05. Medical records state cough, runny nose.					Y	4			Y	10/19/2005	10/21/2005	2	WBC - 30.8, ESR - 19, CRP - 38.13 Information received from medical records show leukocytosis, abnormal test results, increased sed rates. msv	UNK	UNK	Zoloft, protonix, zyrtec, albuterol	Cough, runny nose	Developmental delays, GERD, allergies, strabismus, obesity Information from Medical Records states facial paralysis, asthma, GI disease and immune system disease. msv			1						1	Cellulitis; Cough; Injection site reaction; Laboratory test abnormal; Leukocytosis; Pyrexia; Red blood cell sedimentation rate increased; Rhinorrhoea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0579P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0246313	10/28/2005	OH	9.0	8		M	10/24/2005	Redness and swelling of left arm, area 4cm x 6cm.  Received a IM dose of rocephin 10-20-05.  Also had vomiting and dehydration, admitted to short stay and rehydrated and given clindamycin IV.  Discharged home after one day with oral antibiotics.  Redness continued to increase, readmitted and received vancomycin IV with improvement of redness and swelling. Term added form Dis Summary rec'd 11/30/2005: Cellulitis				Y	Y	3			Y	10/18/2005	10/19/2005	1		UNK	UNK	Singulair, pulmicort	Sinusitis treated with augmentin	mild asthma			1						1	Cellulitis; Dehydration; Erythema; Swelling; Vomiting	FLU3~SANOFI PASTEUR~U1778AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0751P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0246314	10/28/2005	MA	89.0	89		F	10/28/2005	Febrile, weak. Discharge summary states viral infection, dehydration. msv					Y	2			Y	10/25/2005	10/25/2005	0	labs and x-rays all grossly normal Discharge summary states leukopenia, increased creatine; Medical records state urinary tract infection. msv	UNK	UNK	Coumadin, Lasix, Metoprolol, Digoxin, Protonix, Imdur, K-Dur, Remeron	pre-existing mild illness, probably viral	none Discharge summary states coronary artery disease, atrill fibrulation; Medical records state bone disorder, sinus arrest. msv; Pace maker			1						1	Asthenia; Blood creatine increased; Dehydration; Laboratory test normal; Leukopenia; Pyrexia; Urinary tract infection; Viral infection; X-ray normal	FLU3~AVENTIS PASTEUR~U1777AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0246316	10/28/2005	TX	1.51	1	.5	M	10/28/2005	Patient was afebrile and symptom free for 24 hours after vaccine- approximately 36 hours after vaccination he experienced a temperature and chills and within 10 minutes he had a brief seizure event. EMS arrived and pt was postictal but arousing and in no distress. Patient came to the office the following day and during the visit had spike to 102.6 and another seizure event 4 minutes with some L side face and L arm twitching.  Medical record rec'd 11/7/2005 --additonal terms were Pharyngitis and URI/sr				Y					Y	10/24/2005	10/25/2005	1	CBC with manual differential wbc 4.3/hgb11.6 hct34 plt201  chemistry normal, Blood and Urine Cultures normal Cat Scan Head - negative Influenza a/b wash	UNK	UNK		none	mild eczema amoxil - skin rash in past			1						1	Chills; Convulsion; Muscle twitching; Pharyngitis; Pyrexia; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~u1905aa~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246317	10/28/2005	IN	57.0	57		F	10/28/2005	FEVER, CHILLS, VOMITING, DIARRHEA, MUSCLE ACHES. STARTED ABOUT 2 HOURS AFTER SHOT.  VERY BAD THE FIRST DAY. 2ND DAY, STILL SICK, BUT NOT AS BAD, JUST WEAK AND QUEAZY. 3RD DAY STILL SICK PLUS WAS DIZZY AND KEPT LOOSING MY BALANCE. 4TH DAY AND TODAY, MUCH BETTER, BUT NOT BACK TO NORMAL YET.										10/17/2005	10/17/2005	0		UNK	UNK	BOOD PRESSURE & HORMONES	SLIGHT COLD OR ALLERGIES (FALL LEAVES)	ALLERGIC TO PENICILLIN			1						1	Asthenia; Balance disorder; Chills; Diarrhoea; Dizziness; Myalgia; Nausea; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246319	10/28/2005	MD	15.0	15		M	10/28/2005	Pruritic rash- individual bumps described as like bug bites all over his body.									Y	10/19/2005	10/20/2005	1		UNK	UNK	none	none	none			1						1	Rash pruritic	FLUN3~MEDIMMUNE VACCINES, INC.~500391P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0246321	10/28/2005	MN	35.0	35		F	10/28/2005	Patient states the day she received the vaccination she experienced the following: fever, weakness, vomiting and the injection site was red, raised, warm and approximately 3 inches in diameter.									Y	10/25/2005	10/25/2005	0		UNK	UNK		cough urinary incontinence				1						1	Asthenia; Injection site erythema; Injection site swelling; Injection site warmth; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~u1839aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~ahbrb144aa~2~IM~RA~HEP B (ENGERIX-B)~1	USA		Influenza
0246322	10/28/2005	MN	23.0	23		F	10/28/2005	Received vaccine Oct 11, experiened achiness Oct 16, bronchitis, serous otitis with diagnosis Oct 19.  Reaction to flonase, zithromax including oral candida  and diarrhea with additional treatment of bronchitis and yeast infection required Oct 25.Unable to document fever at home, visits to urgent care x3 did not reveal elavated temperature.  Did not feel unusual level of wellness for two weeks.				Y					U	10/11/2005	10/11/2005	0		UNK	UNK	ortho tri cylen	no	no			1						1	Bacterial infection; Bronchitis; Diarrhoea; Otitis media; Pain	FLUN3~MEDIMMUNE VACCINES, INC.~500389p~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0246323	10/28/2005	WA	38.0	37		F	10/28/2005	Hoarseness, tightness in chest, wheezing and coughing spells.				Y					Y	10/25/2005	10/25/2005	0		UNK	UNK	None	None	Environmental allergies only - mildew, dust, ragweed. Pituitary adenoma untreated at present.			1						1	Chest discomfort; Cough; Dysphonia; Wheezing	FLU3~SANOFI PASTEUR~u1745AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246324	10/28/2005	WI	1.5	1	.5	M	10/28/2005	6AM 10/28/05, MOM NOTICED RED, HOT, TENDER, HARD AREA, 2 IN DIAMETER. FUSSY, IRRITABLE.									Y	10/27/2005	10/28/2005	1		UNK	UNK						1						1	Erythema; Injection site induration; Injection site warmth; Irritability; Tenderness	DTAP~SANOFI PASTEUR~U1350DA~4~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U17651A~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246325	10/28/2005	CO	45.0			F	10/28/2005	Pt had pain in left arm when receiving shot.  Pain continued to get worse over subsequent days and she has limited lifting and moving in arm.														UNK	UNK						1						1	Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U1905AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246326	10/28/2005	OR	22.0	22		F	10/28/2005	Developed vesicular rash 3 days after varivax administration.									Y	10/24/2005	10/28/2005	4		UNK	UNK	none	none	mental retardation, very mild			1						1	Rash vesicular	FLU3~SANOFI PASTEUR~U1746AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0825P~2~IM~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0246327	10/28/2005	CA	3.0	2	.9	M	10/28/2005	Patient developed fever and flu-like symptoms, including vomiting for two days, cough, rhinorrhea, muscle aches, and possible sore throat. Symptoms not yet resolved as of this report. Parents unsure if he received flu shot last year, and records not yet available from prior office.									U	10/26/2005	10/26/2005	0	strep negative, pulse ox 97%, urine negative for infection	UNK	UNK	albuterol, flovent	had already vomited once, thought due to car-sickness	asthma			1						1	Cough; Influenza like illness; Myalgia; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea; Vomiting	FLU3~SANOFI PASTEUR~U1743LA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246337	10/28/2005	AR	43.0	43		F		Pt employee in CCU. Pt stated seeing stars, laid on floor, became flushed, vomited and lost consciousness. Rush to ER - 1000 cc normal saline, AQ adrenalin 0.3 SQ, Benadryl 25mg, Xopenex aerosol, Decadron 4 mg IV.  Pt called at 3:15 doing well.			Y	Y					Y	10/26/2005	10/26/2005	0		PVT	PVT	NONE		Rheumatic Fever 79 11/7/05 Review of medical records indicates history of asthma.	Vertigo~Influenza (Seasonal) (no brand name)~1~37.00~In Patient		1						1	Chest discomfort; Dizziness; Dyspnoea; Flushing; Loss of consciousness; Rash; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA122AB~UNK~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Life Threatening	Influenza
0246339	10/28/2005	MN	37.0			M	10/28/2005	This case was reported by a pharmacist and described the occurrence of digital vasculitis in a 37 year old male subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. This case was also reported by a physician. The pharmacist and physician reported that the subject is a physician. The subject had no pre-existing medical conditions. On 25Oct05 the subject received 1st dose of Fluarix in an unspecified arm (lot number not provided). Within 24 hrs after vaccination with Fluarix, on 26Oct05, the subject experienced bilateral digital vasculitis characterized as petechiae of the fingertips and fingertips that are very sensitive to touch, unable to type. At the time of initial reporting, 27Oct05, the events were worsening. The pharmacist considered the events to possibly be related to vaccination with Fluarix. Digital vasculitis was assessed as medically serious by manf (OMIC).									U	10/25/2005	10/26/2005	1	UNK	OTH	OTH		UNK	The subject had no pre-existing medical conditions. The subject's concurrent conditions and concurrent medications were not reported.		A0579829A	1						1	Hypersensitivity; Petechiae; Vasculitis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246344	10/28/2005	CA	55.0	55		F	10/18/2005	C/O fever of 103 degrees (temp taken with glass thermasat) and chills shaking so bad I can't hardly function. Fever down by 10 am the following morning - she took antipyretic. Complete recovery in 24 hours.									Y	10/17/2005	10/17/2005	0		PUB	PUB			Real dizzy, chronic hepatitis, fibromyalgia, diabetes, anemia, asthma		ca050071	1						1	Tremor	FLU3~SANOFI PASTEUR~U1754AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246345	10/28/2005	TX	68.0	68		F	10/28/2005	Itchy rash around injection site and on legs, both real red (None on arms, face or anywhere else) Took Benadryl to help itching. She saw Dr. No additional treatment needed.									U	10/27/2005	10/28/2005	1		UNK	UNK						1						1	Erythema; Rash	FLU3~SANOFI PASTEUR~U1817AA~7+~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246349	10/28/2005	IN	55.0	54		F	10/28/2005	Swollen lips, neck, throat. Hives face/neck. Wheeze				Y					Y	10/27/2005	10/27/2005	0		PUB	PVT	lipitor 10mg, HCTZ 25mg, effxor, Trazadone		environmental allergies, sulfur allergie			1						1	Pharyngeal oedema; Swelling face; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U1839AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246350	10/28/2005	OH	71.0	71		M	10/27/2005	Severe upper arm swelling erytherma and edema									Y	10/25/2005	10/26/2005	1		PVT	PVT						1						1	Erythema; Oedema; Swelling	FLU3~SANOFI PASTEUR~U1810AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246351	10/28/2005	OH	69.0	69		F	10/27/2005	Severe upper arm edema and swelling encompassing entire upper arm									Y	10/25/2005	10/27/2005	2		PVT	UNK						1						1	Oedema; Swelling	FLU3~SANOFI PASTEUR~U1810AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246352	10/28/2005	OH	67.0	67		F	10/27/2005	Severe upper arm edema, erythema, vessicles, itching									Y	10/25/2005	10/26/2005	1		PVT	PVT						1						1	Blister; Erythema; Oedema; Pruritus	FLU3~SANOFI PASTEUR~U1810AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246353	10/28/2005	NY	69.0	69		M	10/28/2005	Swelling, heat and erythema in arm distal to injection site, involved entire area				Y					Y	10/26/2005	10/26/2005	0		PUB	PUB			HTN, COPD			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~u1829na~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~9570905~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246354	10/28/2005	FL	86.0	86		F	10/28/2005	10/19/05 high temperature 1 AM 103 degrees to 4 AM 99.2 AX 10/21/05 started on macrobid for UTI									N	10/18/2005	10/19/2005	1	10/20/05 final c/s (unable to read the rest)	OTH	OTH	Plavix, oscal, tylenol, biafine	nasal discharge	dementia, hypertension, s/p pneumonia			1						1	Body temperature increased; Urinary tract infection	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU1258C~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246355	10/28/2005	NY	54.0	53		F	10/28/2005	Received flu vaccine at 2pm on 10/24/05. On 10/25/05 woke up systemic hives. Treated by PMD- benadryl and prednisone 20 mg x 5 days.				Y					Y	10/24/2005	10/25/2005	1		PUB	PUB	naprosyn, lovastatin, BP pill, femart	slight cold	latex, penicillin			1						1	Urticaria	FLU3~SANOFI PASTEUR~U17431A~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246356	10/28/2005	CA	77.0	77		F	10/24/2005	Pain and redness at injection right arm to elbow, redness progressive. Pain receding as of 10/22/2005. Pt tried ice, Benadryl, and Aleve				Y					N	10/20/2005	10/20/2005	0		OTH	PVT		Asthma	Asthma			1						1	Injection site hypersensitivity; Injection site pain	FLU3~SANOFI PASTEUR~U1903AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1039P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246330	10/29/2005	MN	68.0	67		F	10/29/2005	A case of Shingles developed within two days of flu vaccination.  Still ongoing, 2 weeks after.										10/14/2005	10/15/2005	1	Shingles confirmed by doctor on 10/24/05.	UNK	UNK	Lipitor 40 mg.	None	None			1						1	Herpes zoster	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246331	10/29/2005	TN	56.0	56		F	10/29/2005	Received the flu vaccine around 12 p.m., on Friday, Oct. 28, 2005.  Around 7:30 p.m., I started having trouble breathing.  Starting wheezing, felt weak all over, had heart palpitations.  This lasted until 2:15 a.m., Saturday morning, Oct. 26, 2005.  I never had an allergic reaction like this before when I took the flu shot.  I was almost at the point where I wanted to call 911, but when it subsided, I was able to sleep.  Woke up around 12:10 p.m. on Saturday afternoon, and have been feeling all right since the episode. I will call my doctor on Monday to report the incident of the reaction of the flu shot.  One more thing... when I was given the flu shot in my left upper arm, it hurt terribly. My arm was immediately sore. (it still is somewhat sore) This is an experience that never happened before either.  So can you explain why this happened to me with this flu vaccine?  I'm not sure what to enter in #13.  All I can tell you that it was the influenza vaccine shot in the arm.									Y	10/28/2005	10/28/2005	0		UNK	UNK		I had no illnesses at the time of the vaccination	I am only allergic to cat dander.			1						1	Asthenia; Dyspnoea; Pain; Palpitations; Wheezing	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0246332	10/30/2005	CA	56.0	55		F	10/30/2005	Fever X 2days (101F) w/ joint aches, which was listed as possible reaction, but also severe vomiting x 1 days.									Y	10/28/2005	10/29/2005	1	None	UNK	UNK	NONE	None	Mild intermittent asthma, allergies to Septra, Erythromycin.			1						1	Arthralgia; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246333	10/30/2005	NV	61.0	60		F	10/30/2005	Pt. rec'd vacc. 10/28 within 2 hours after vacc. pt experienced chest pain L posterior chest wall. Comes into the clinic 10/30 EKG done, Chest x-ray done.				Y						10/28/2005	10/28/2005	0		UNK	UNK						1						1	Chest pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA154BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0246334	10/30/2005	IL	1.27	1	.3	F	10/30/2005	The child was found unresponsive in her crib.  The child was experiencing a seizure (tremors) which involved her right upper and lower extremity and right side of face.  The child was foaming at the mouth.  The seizure lasted approximately 15 minutes and paramedics were called.  Pediatrician was paged.  By the time paramedics arrived, the seizure had ended.  We were advised by pediatrician to take the child to the hospital emergency room.  After that first incident, the child had 11 seizures in the last 3 years.  The child is currently under the care of pediatric neurologist and several anti-seizure medications were tried.  The child is currently on her 3rd anti-seizure medication. Per follow up 01/03/2006 she now has a seizure disorder and is on anti-seizure medication. Follow up received 04/05/2007. Patient has been on seizure meds for over 3 yrs now.				Y	Y	3		Y	N	10/21/2002	11/04/2002	14	1.  Two MRIs of the brain - both negative 2.  Short EEGs and 48hr EEG - all negative 3.  Blood tests - all negative	UNK	UNK	None	None	None			1						1	Coma; Convulsion; Salivary hypersecretion	FLUX~UNKNOWN MANUFACTURER~U0882AA~1~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0246335	10/31/2005	MI	49.0	49		M	10/31/2005	Hives on right arm at the area of the elbow.  On the outer side of the elbow, not on the cease or heel of the elbow.  Covering an area 3 by 4 inches. Mild itching sensation.									U	09/26/2005	09/28/2008	1098		UNK	UNK	Effexor	none	CT iodine, bacatracine, latex, dogs, cats, rag weed, pollen, mild beef and tomatoe allergy, etc.			1						1	Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246346	10/31/2005	WA	33.0	32		F	10/28/2005	Normal prep and counseling for shot. At injection patient flinched and said it felt as needle inbed into arm. Immediately said feeling faint, with 5 seconds passes out in sitting position and head back and actually did not appear to be breathing as we began calling 911 and attempted to get pt to prone position. As we began to try to move her she came to and began to respond. In about 10 minutes paramedics came and she did not want to go to the hospital. They worked with her and in about 50 she was able to go home with a friend.									Y	10/28/2005	10/28/2005	0		UNK	UNK		NONE				1						1	Dizziness; Injection site pain; Loss of consciousness; Respiratory disorder	FLU3~SANOFI PASTEUR~U1818AB~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246347	10/31/2005	NY	91.0	90		F	10/28/2005	Temp 101, chills, nausea, treatment Tylenol, Fluids.									Y	10/28/2005	10/28/2005	0		OTH	PVT						1						1	Chills; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~U1854AA~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246348	10/31/2005	TX	83.0	83		F	10/28/2005	Around 4:30- 5:00 pm pt noticed pain in left arm with redness, swelling and heat. She contacted pharmacy where she was instructed to take Benadryl. Pain and swelling persisted she contacted doctor office who advised to use warm compresses. Follow up with pt indicates improvement with decreased swelling and pain with time. Redness persist and is moving down arm.									Y	10/26/2005	10/26/2005	0	NONE	OTH	PUB		NONE				1						1	Erythema; Feeling hot; Oedema; Pain	FLU3~SANOFI PASTEUR~U1817AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1007P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246367	10/31/2005	OH	60.0	60		F	10/26/2005	A 50 year old female with a medical history of epilepsy since age 13 and brain surgery in Feb 1999 received a .25ml injection of Influenza vaccine, lot number unk, on 19Oct05 at 1:30PM. The route and site of administration and number of previous doses were also unk. Ten hrs later at 11:15PM, the pt experienced a staring seizure (not grand mal) and could not walk. The duration of the seizure was 30 minutes. Illness at the time of vaccination and other medications were unk. The last documented seizures were 23Aug05, 03Aug05 and 23Mar05. The pt's next neurology visit is scheduled for 11Nov05. At the time of this report, the pt had recovered.				Y					Y	10/19/2005	10/19/2005	0		OTH	UNK			The pt has a history of epilepsy since age 13 and had brain surgery in Feb 1999. Illness at the time of vaccination and other medications were unk.		200502177	1						1	Convulsion; Difficulty in walking; Gaze palsy; Hypokinesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0246369	10/31/2005	MI	47.0	47		F	10/26/2005	Tightness in throat, increased heart rate, decreased O2.  Information received from Discharge summary states pharyngitis. msv				Y	Y	1			Y	10/04/2005	10/04/2005	0	With further testing, 10/25/2005 had skin test of allergic reaction to Flu shot, result positive, with itching occurred 2 1/2 hours after and into 10/26/2005.	PVT	PVT	Synthroid					1						1	Heart rate increased; Hypersensitivity; Hypoxia; Pharyngitis; Pruritus; Throat tightness	FLU3~SANOFI PASTEUR~U1778AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0246370	10/31/2005	MS	59.0	59		F	10/24/2005	Redness and edema right deltoid, resulting in cellulitis and edema right arm into right side of neck and face. Saw ER physician on Monday night 10/17/2005 and 10/18/2005, saw family MD on 10/19/2005, was put into hospital 10/19/2005 and released on 10/21/2005.				Y	Y	2			Y	10/17/2005	10/17/2005	0		PUB	PUB	HIV med		HTN			1						1	Cellulitis; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1811AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0246371	10/31/2005	AR	70.0	70		F	10/31/2005	C/O red, swollen and painful at site started itching 1 hour after injection. C/O not feeling well such as joint aching and fatigue.									Y	10/27/2005	10/27/2005	0		PVT	PVT			Allergies, codeine, Penicillin			1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA12SAC~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0605R~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246372	10/31/2005	OR	76.0	75		F		Arm that got the shot became extremely sore after several hours. Couldn't move arm at all w/o getting extreme pain. Unable to undress or dress, etc. lasted about one week, *Pneumococcal.				Y					Y	10/12/2005	10/12/2005	0		PVT	OTH						1						1	Hypokinesia; Injection site pain; Injection site reaction	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~UNK~UNK~~UN~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0246373	10/31/2005	PA	5.0	4		F	10/25/2005	After 10 min pt turned red and listless and started with hives. Within 10 more minutes pt vomited. Pt was given Benadryl T2cc EPI 1:1000, Pt started with redness at 2:50 and given 2CC EPI 1:1000.									Y	10/25/2005	10/25/2005	0		PVT	PVT	NONE	NONE	Astrocytoma removed 3 years ago			1						1	Erythema; Listless; Urticaria; Vomiting	DTAP~SANOFI PASTEUR~C2278AA~5~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1763AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0326~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0295R~2~IM~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0246374	10/31/2005	OR	78.0	78		F	10/25/2005	Shoulder developed pain and swelling over course of a few days. MD gave patient prednisone tabs and pain and swelling are resolving.				Y					U	10/11/2005	10/12/2005	1		OTH	OTH						1						1	Oedema; Pain	FLU3~SANOFI PASTEUR~U1811AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246375	10/31/2005	TN	66.0	65		F	10/22/2005	Hives rash around neck, between and under breast. Slight elevation of temp. Big red ring slightly off center from injection point. Scalp crawled, some slight chills, cough. My opinion I have never reacted to a flu vac, so I think I reacted to the pneumonia one. It stung while being injected.									Y	10/19/2005	10/20/2005	1		PUB	PUB	I take Lipitor and Allegra	NONE	I am allergic to some medicines and some environmental allergens.			1						1	Chills; Cough; Injection site hypersensitivity; Paraesthesia; Pyrexia; Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~UNK~UNK~~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0246376	10/31/2005	CA	4.0	4		M	10/25/2005	Developed hives after Fluzone approx 15 minute with administration itchy and stated skin felt hot. Benadryl given in office. Hives resolved approx 8 hours later saw allergist next day.				Y					Y	10/11/2005	10/11/2005	0		PVT	PVT	Zyrtec	NONE	Sulfa allergy PCN, Tetralogy of Fallot, hypospadias			1						1	Feeling hot; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1818AB~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246377	10/31/2005	WI	64.0	64		F	10/24/2005	Redness - swelling of upper arm shoulder to elbow. Right arm diagnosed as cellulitis.				Y					Y	10/15/2005	10/15/2005	0		OTH	PVT		NONE	NONE			1						1	Cellulitis; Erythema; Oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0246378	10/31/2005	MI	28.0	27		F	10/21/2005	Difficulty breathing, wheezing after vaccination. Given Epinephrine & Benadryl - responded with improved breathing. Sent to ER. Observed treated with steroids and released in stable condition.				Y						10/18/2005	10/18/2005	0		UNK	UNK		Asthmatic Bronchitis	Asthma, Seizure disorder			1						1	Dyspnoea; Wheezing	FLU3~SANOFI PASTEUR~U1903AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246379	10/31/2005	KS	22.0	22		F	10/26/2005	Pt. reports had a firm area at injection site. By 9 pm on 10-25-05. Pt went to bed, awoke at 3 am vomited one time, returned to bed. Upon awakening noted red firm area at injection site. Examined pt at the office (1320) 10/26 area 6 cm x 5cm reddened, indurated.									Y	10/25/2005	10/25/2005	0		PVT	PVT	Birth Control Pill, Topamax (night before)	NONE	Migraines, Anemia			1						1	Injection site erythema; Injection site induration; Vomiting	FLU3~SANOFI PASTEUR~U177AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246380	10/31/2005	ME	77.0			U		On 10-21-05 pm developed the following Sx fever, chills, sweating. From elbow to mid rt arm red and tender, denies swelling. Developed rash waist, under arms, breast, eyes and cheek. Denied any sob or wheeze at anytime. 10/26/05 Sx improving afebrile rash.									Y					PUB	OTH	Tamoxifen	Breast Cancer				1						1	Chills; Erythema; Hyperhidrosis; Pyrexia; Rash; Tenderness	FLU3~SANOFI PASTEUR~U180AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0531P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246381	10/31/2005	MI	9.0	8		F	10/24/2005	On Benadryl for sinus since 10/20/05. Itchy face red rash head to toe w/in 12 hrs. Worsened 10/22, began improving 10/23. Lactose intolerant. Allergy history -  slight allergy to raw eggs. 2000 eat food with eggs with no problem.									Y	10/21/2005	10/21/2005	0	NONE	PUB	PUB	Benadryl	Sinus Pressure  No temp	Penicillin - severe hives		MT0511	1						1	Rash erythematous; Rash pruritic	FLU3~SANOFI PASTEUR~U1830AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246382	10/31/2005	NY	44.0	44		F	10/27/2005	Arm swelled (welts), burning, hot to touch, ache under arm, redness & swelling traveled up & down arm. Emergency room visit, received cefuroxime Axetil.				Y					N	10/22/2005	10/22/2005	0	Cellulitis Inflammation	OTH	UNK						1						1	Cellulitis; Erythema; Feeling hot; Oedema; Urticaria	FLU3~SANOFI PASTEUR~U182AM~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1007P~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246383	10/31/2005	KS	67.0	67		F	10/24/2005	S/S soreness & tenderness in R arm, redness at injection site with red streak going around inner 1/2 of arm. Achiness, fever no degrees. Induration at injection site. TX: Benadryl Injection & Ice to injection site.				Y					Y	10/12/2005	10/13/2005	1		PUB	PVT		NONE	NONE			1						1	Injection site erythema; Injection site induration; Myalgia; Pain; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~U1775AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0513P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246384	10/31/2005	IA	56.0	56		F	10/25/2005	30 minutes after injection felt itching all over. Injection site swelling & red.									Y	10/24/2005	10/24/2005	0		MIL	PVT						1						1	Injection site erythema; Injection site oedema; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA151AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246385	10/31/2005	IA	23.0	23		F	10/25/2005	12 hours after immunization had itching all over.									Y	10/24/2005	10/24/2005	0		MIL	PVT				itching~Influenza (Seasonal) (Fluarix)~~22.00~In Patient		1						1	Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA151AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246386	10/31/2005	WA	9.0	9		M	10/21/2005	A 9-year-old boy who is with a complex history today relating to a flu shot. Since receiving his flu shot, within 12 hours, mom has noticed him to be highly anxious and worried unnecessarily so. He has had tic-like behaviors, which have included mouthing at clothing, being excessively fidgety, as well as habitual coughing. He had an episode like this back almost two years ago, and mom stated it came right after a flu shot as well. Going back through the records I see that he had a flu vaccine on 11/12/03. This time, his mom said that within a week he was ill, and he had a viral-like syndrome where he took some prednisone. Shortly after this, within a month, he developed obsessive-compulsive disorder symptoms and high anxiety including tics with habitual coughing, head tilting, and a need to smell objects habitually. He was seen by doctor in play therapy which did not result in a tremendous amount of improvement. He was ultimately put on Zoloft to help with his high levels of anxiety and OCD symptoms in January of 2004, but this was apparently  a disaster, according to mom and he became very naught and misbehaved. He was therefore taken off of the Zoloft and switched over to Prozac, which was helpful for him, and he took it until May or June of 2004. At which time, he had discontinued it, and he really had not had any return of any symptoms until  his recent flu shot. To complicate matters, he did come back in, in the middle of January, and he had a strep screen at that time which was positive. It was thought that he might have PANDAS syndrome, and he was treated for strep, although he continued to have residual symptoms for several months thereafter. He is in today with no sore throat, fever, cough, or other symptoms, although his strep screen actually comes back and is positive today as well. He has continued to exhibit OCD symptoms, anxiety, and tics since his flu shot was given on Friday, and there has been no general improvement up to today.									N	10/14/2005	10/14/2005	0	Strep ROP	PVT	UNK		NONE	NONE			1						1	Abnormal behaviour; Anxiety; Cough; Obsessive-compulsive disorder; Posture abnormal; Psychomotor hyperactivity; Streptococcal serology positive; Tic; Viral infection	FLU3~SANOFI PASTEUR~U1832BA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246387	10/31/2005	NE	24.0	23		F	10/27/2005	10/20/2005 6pm reports tickle in throat. 6:45 pm reports dyspnea and tightness in chest, lightheadness, used albuterol MDI w/o relief. Went to Urgent care heart rate was 145 min. Was given an injectable steroid. Left urgent care 9:30 with HR of 112 minute.				Y					Y	10/20/2005	10/20/2005	0	Client states EKG unsuccessful, Oxygen saturation was 100%	OTH	PVT	Albuterol inhaler, Allegra D, Synthro, Nortel (7-7-7 birth control)	NONE	Asthma, Hashimoto thyroiditis, seasonal allergies. PNC allergy			1						1	Chest discomfort; Dizziness; Dry throat; Dyspnoea; Heart rate increased	FLU3~SANOFI PASTEUR~U1811AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246388	10/31/2005	NY	58.0	57		F	10/28/2005	Patient called on 10/27/2005 saying after receiving flue shot on 10/26/2005 she was feeling dizzy, achy and ill when questioned, she reported itching and a rash she was advised to go to ER she refused. Called next day 10/28 she said rash was gone she was feeling better.									Y	10/26/2005	10/26/2005	0	NONE	OTH	PVT		NONE	NONE			1						1	Dizziness; Malaise; Pain; Rash pruritic	FLU3~SANOFI PASTEUR~U1762AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246389	10/31/2005	HI	56.0	55		F	10/24/2005	Chills, feverish, lower abdominal pain, headache and lower back pain symptoms.									Y	10/20/2005	10/21/2005	1		OTH	PVT	Dynacire, Concerta, protomx, ASA, vitamins				HI0504	1						1	Abdominal pain lower; Back pain; Chills; Headache; Pyrexia	FLU3~SANOFI PASTEUR~U1818AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246407	10/31/2005	MA	10.0	9		M	10/31/2005	14 cm x 5 cm erthy/swollen area L upper arm at site of vaccination. Fever 103-104				Y					Y	10/25/2005	10/26/2005	1	NONE	PVT	PVT	Motrin, Qvarl Singular	NONE				1						1	Injection site erythema; Injection site swelling; Pyrexia	FLU3~SANOFI PASTEUR~U1804AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246408	10/31/2005	OH	67.0	66		M	10/31/2005	Pneumovax given R deltoid on 10/25/05 pt. noted redness, swelling on 10/26/05 IM. Seen Dr. 10/27/05 advised Benadryl & cold pks. On 10/31/05 no symptoms				Y					Y	10/25/2005	10/26/2005	1	NONE	PVT	PUB	Procardia, Tenormin, Flonase, Lortab	HTN, BPH	PCN			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1810AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0579P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246410	10/31/2005	TX	52.0	52		F	10/25/2005	Pt states left arm hurt on injection 10/20/05 and noted swelling that night which lasted with rash until 10/23/05. Pt took Benadryl and ASA.  Reported to Health Department 10/25/2005. No s/s noted.									Y	10/20/2005	10/20/2005	0	N/A	UNK	UNK	Ogen D, Darvocet prn	Had wasp sting 2 weeks ago	none		MS05017	1						1	Injection site pain; Rash; Swelling	FLU3~SANOFI PASTEUR~01806AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246411	10/31/2005	MA	39.0			F	10/31/2005	Received flu shot at clinic on 10/26/05  Developed periorbital swelling about 6 hrs later  Went to personal MD, treated with Benadryl. No history of allergies, no known previous reaction to vaccines (has had several Flu shots in past).				Y					Y	10/26/2005	10/26/2005	0		UNK	UNK	none	no				1						1	Periorbital oedema	FLU3~SANOFI PASTEUR~~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246412	10/31/2005	GA	33.0	33		M	10/31/2005	Patient did not visit a healthcare professional until 10/28. He said a rash was noted the evening of the immunization(6 hrs. later). On 10/28 he presented to a clinic with a body rash, swollen eyes,swollen rt. hand and SOB. He was treated with Prednisone 20mg BID for 5 days and Allegra for 7 days.				Y					Y	10/26/2005	10/26/2005	0	None	UNK	UNK		None	None			1						1	Dyspnoea; Eye swelling; Oedema peripheral; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500392P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0246413	10/31/2005	PA	40.0	39		F	10/31/2005	Rash appeared approx. 45 min. hr after shot. Called nurse who administered it and left message on her cell phone.  Never returned my call. Rash started on both arms then spread to neck and back and went away after an hour.  Next morning started dizziness, sweating and extreme fatigue with vomiting.  Had to use 2 1/2 days of my vacation/sick time till able to return to work.									Y	10/25/2005	10/25/2005	0		UNK	UNK						1						1	Dizziness; Fatigue; Hyperhidrosis; Rash; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246414	10/31/2005	NM	25.0	24		F	10/31/2005	Developed swelling of the throat, aches, chills, and swollen eyes.									Y	10/25/2005	10/25/2005	0	None	UNK	UNK	None	None	None			1						1	Chills; Eye swelling; Pain; Pharyngeal oedema	FLU3~SANOFI PASTEUR~U1832BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246415	10/31/2005	MO	1.05	1	.1	F	10/31/2005	Mother states child started having what looked like flea bites on her legs appoximatly 2 weeks ago they progressed to back and head over this past weekend and sites on legs are now crusted over.  States child had fever several times over the weekend.									U	09/29/2005	10/17/2005	18		UNK	UNK		No	Allergy - PCN			1						1	Rash	FLU3~SANOFI PASTEUR~u1744aa~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0347r~3~IM~RL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0602r~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0068r~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0246416	10/31/2005	MD	35.0	35		M	10/31/2005	Nausea x 4 days. Fatigue, lightheadedness, dizziness persisting X 7 days. Shortness of breath when lying flat. Objectively normal orthostatic vitals, neuro exam, physical exam. Supportive care recommended.									U	10/25/2005	10/26/2005	1	CBC normal. Other labs pending.	MIL	MIL	none	none	cervical dysplasia	nausea~Influenza (Seasonal) (Fluzone)~~4.80~Patient		1						1	Dizziness; Dyspnoea; Fatigue; Nausea	FLU3~SANOFI PASTEUR~U1839AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246417	10/31/2005	MS	54.0	53		F	10/31/2005	Received vaccine on afternoon of 10-25-05. By  8:00 PM that night, developed baseball-sized knot at site of injection. Over the next three days, the swelling increased in size and gradually migrated down my arm, accompanied by area of intense redness -- from the acromium process down to the antecubital space. Entire upper arm was very swollen, red, hot-to-touch,  and very tender -- preventing restful sleep for two nights.									Y	10/25/2005	10/25/2005	0	N/A	UNK	UNK	estradiol 1 mg tablet daily	none	none			1						1	Injection site erythema; Injection site mass; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246419	10/31/2005	TX	51.0	51		F	10/31/2005	Itchy red rash approximately 24 hours after vaccine administered. Benadryl given at night with kenalog cream applied during day.				Y					Y	10/14/2005	10/15/2005	1		UNK	UNK						1						1	Rash pruritic	FLU3~SANOFI PASTEUR~u1849aa~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246420	10/31/2005	TX	33.0	33		F	10/31/2005	Red, itchy rash, anxious feeling. Given Benadryl.				Y					Y	10/12/2005	10/12/2005	0		UNK	UNK						1						1	Anxiety; Rash pruritic	FLU3~SANOFI PASTEUR~u1806aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246422	10/31/2005	MI	42.0	41		F	10/31/2005	Vaccine given at 4:30pm 10/17 at 8:30 pm felt short of breath, chest tightness and used inhaler. 10:30 to 11:00 pm began shivering Temp 101 oral and continued til 4am when temp broke. Had a severly debilitating headache. On 18th was ill all day with malaise, headache, and muscle aches which lasted 2 days.									Y	10/17/2005	10/17/2005	0	None	UNK	UNK	None	None	Chronic CSF leak			1						1	Chest discomfort; Chills; Dyspnoea; Headache; Malaise; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1904AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246423	10/31/2005	CA	67.0	67		F	10/31/2005	Congestion, headache on one side, difficulty breathing through that side of nose, aches, cold symptoms.									Y	10/26/2005	10/26/2005	0		UNK	UNK	Atenolol, lisinopril, levothroid, hydrochlorothiazide	none	Allergic to penicillin and sulfa drugs.			1						1	Dyspnoea; Headache; Nasal congestion; Pain; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246424	10/31/2005	MN	16.0	15		M	10/31/2005	Erythema, tenderness, induration, and warmth of upper right arm, including the injection site, and fever, consistent with cellulitis.				Y						10/28/2005	10/30/2005	2	CBC showed leukocytosis.	UNK	UNK	Celexa, Risperdal, Dexedrine, Nortriptyline	none	Pervasive developmental disorder, dysthymia, attention deficit disorder			1						1	Cellulitis; Injection site erythema; Injection site induration; Injection site pain; Injection site reaction; Injection site warmth; Leukocytosis; Pyrexia	FLU3~SANOFI PASTEUR~U1802BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1812AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PPV~MERCK & CO. INC.~0287P~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2151AC~1~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0246425	10/31/2005	MA	56.0	55		F	10/31/2005	Patient had flu vaccine injection 10/12/05 between 1-2:00 p.m. at work.  Had no symptoms of current illness.  Experienced a seizure that evening approx. 6-7:00 p.m. while at the dinner table.  Body became rigid, LOC, and pt. bit her tongue.  No loss of urine.  No report available of extremity motions. Seen in Emergency department. In ICU for 24 hours then medical floor for another 24  hours.  CT -cranial was negative.  Lab work showed mild elevation of TSH Medical records state cerebral edema. msv				Y	Y	2			Y	10/12/2005	10/12/2005	0	Subsequent repeat CT scan was negative.  Post seizure EEG was negative and also a brain MRI of was negative. Discharge summary states abnormal EEG, hyperthyroid. msv Medical records state abnormal lab results. msv	UNK	UNK	Lexapro 20mg/daily Estradiol 1 mg/daily	None	Ovarian wedge resection 1972 Hysterectomy 1994 Right carpel tunnel release 1990 Medical records states depression. msv			1						1	Brain oedema; Convulsion; Electroencephalogram abnormal; Hyperthyroidism; Laboratory test abnormal; Loss of consciousness; Musculoskeletal stiffness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA138BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0246428	10/31/2005	WA	54.0	53		M	10/31/2005	Employee who is complaining of double vision since the morning after the vaccination. According to the employee symptoms are worsening. He also complains of flushing on raising in the a.m.										10/26/2005	10/27/2005	1		UNK	UNK		none	Employee reports none			1						1	Flushing; Hepatocellular damage	FLU3~SANOFI PASTEUR~U1778AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246447	10/31/2005	AZ	1.21	1	.2	F	10/31/2005	Large red confluent area on ant. abdomen & chest. Few raised red irregular areas on torso. No rash at site of injection. Gave Benadryl 1/2 tsp po. Swelling & redness lessened over 1 1/2 hours. Completely recovered by 10-31-05. Medical records state facial edema, agitation, rash. msv				Y					Y	10/28/2005	10/28/2005	0	NONE	PVT	PVT	NONE	NONE	Eczema			1						1	Agitation; Erythema; Face oedema; Rash	FLU3~SANOFI PASTEUR~U1743LA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246448	10/31/2005	NY	53.0	52		F	10/28/2005	Chills, body aches approx. 4 hrs after eyes bloodshot & felt swollen (did not take mpi) weak & nauseated - went to bed today to sleep it off. Still a little achy on 10/28 & 10/29									Y	10/27/2005	10/27/2005	0		OTH	UNK	Estradiol 15 mg Caltrate 600	NONE	Mild Asthma			1						1	Asthenia; Chills; Nausea; Ocular hyperaemia; Oedema; Pain	FLUX~SANOFI PASTEUR~U1755AA~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246449	10/31/2005	LA	66.0	66		F	10/31/2005	10-31-05 Pt presents to clinic small bruise noted at injection site L delt. Bruising noted below deltoid area. Pt report delt. was very sore on evening of injection. No problems at time of injection. Reports redness, swelling and itching of entire deltoid area when pt awoken 10/29/05 am. Began to reduce on 10/30/05. 10/3/05 MD ordered Benadryl.				Y					Y	10/28/2005	10/28/2005	0		PVT	OTH	Actonel;Glucophage;Lotrel;Lipitor;Ca;Aisphex, Legian;Premarin;Ceclor;Mycin;Sulfa;Codeine	NONE	DM;DA;HTN;Hyperlipaemia			1						1	Contusion; Hypersensitivity; Injection site erythema; Myalgia; Pruritus	FLU3~SANOFI PASTEUR~U1833BA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1006P~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246450	10/31/2005	GA	10.0	9		M	10/31/2005	Severe headache/pale/diaphoretic weak but oriented. Oxygen give, after 15 min. color returned. Ambulate well.									Y	10/29/2005	10/29/2005	0		PVT	PVT	NONE	NONE	NONE			1						1	Asthenia; Headache; Hyperhidrosis; Asthenia; Headache; Hyperhidrosis; Hypoxia; Pallor	FLUN3~MEDIMMUNE VACCINES, INC.~500392P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500392P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0246469	11/01/2005	OH	47.0	46		F	10/27/2005	Received vaccine around 15:00 on 10/25/2005 by 16:00 on 10/25/2005 patient started feeling light headed, dizzy, sweating progressed to the point of loss of control, slurred speech, unable to tie shoes. Presented to ED with Temp of 91F, near syncope, K=2.5 mmol/L, Blood Glucose = 37 mg/ol. Medical records state sweat, asthenia, hypothermia. msv				Y	Y	2			Y	10/25/2005	10/25/2005	0	K=2.5 mmol/L, Blood glucose 37 mg/ol. Medical records state leukocytosis, albumiuria. msv	OTH	OTH	Synthroid		History of Hypothyroidism.			1						1	Albuminuria; Asthenia; Blood glucose decreased; Blood potassium decreased; Dizziness; Dysarthria; Hyperhidrosis; Hypokinesia; Hypothermia; Leukocytosis; Pyrexia; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0246472	11/01/2005	PA	71.0	71		M	10/26/2005	Go shot at 8:30am at home. At 10pm heart was racing and I got very dizzy. Went right to bed woke up about 7am all symptoms gone.									Y	10/16/2005	10/16/2005	0		OTH	PUB	Coreg, Warfarin, Glucophage, Albuterol, Micronase, Digitalis, Lipitor.	Type 2 Diabetes; Bronchitis	Allergic to peanuts since youth; Lasix.	None~ ()~~0.00~Patient		1						1	Dizziness; Heart rate increased	FLU3~SANOFI PASTEUR~U1914AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246473	11/01/2005	IL	20.0	20		F	10/27/2005	L deltoid with 1mm clear vesicle @ injection site with surrounding 3X4cm oval induration with mild pain.									Y	10/25/2005	10/26/2005	1	NONE	PVT	PVT	Mircette-OCP	NONE	History VSD - (closed)			1						1	Injection site induration; Injection site pain; Injection site vesicles	FLU3~SANOFI PASTEUR~U1832BA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246474	11/01/2005	OK	52.0	51		F	10/26/2005	On 10/25/05 I got the vaccine about 10:30am at 3:00pm I had tightness in my chest so bad I could not lay down, so I walked around the house. I was sick at my stomach.									Y	10/25/2005	10/25/2005	0		OTH	PVT		NONE				1						1	Chest discomfort; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246475	11/01/2005	OK	66.0	66		M	11/26/2005	About 4 hours after vaccine arm very sore 3/4 swelling at site. Arm hurt bad enough he couldn't make a fist. 10/26/05 today it's ok a little sore but can move it. Patient stated  this was a second dose. No treatment sought. Used ice pack & Tylenol.  10/18/99 #1pneumoccocal vaccine.									U	10/25/2005	10/25/2005	0		PUB	OTH		Denies	Diabetic			1						1	Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1824AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0791P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246476	11/01/2005	MI	6.0	5		M	10/27/2005	24 hrs after vaccination purpura, Buttock & arms with mild prolonged P.T. Sibling vaccinated as well with similar clinical uresqulation, may be Henoch-Schonlein Purpura.										10/21/2005	10/22/2005	1	Pending/ ISA	PVT	UNK			Asthma			1						1	Henoch-Schonlein purpura; Pain; Purpura; Tenderness	FLU3~SANOFI PASTEUR~U1839AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246477	11/01/2005	MI	1.66	1	.7	M	10/27/2005	48 hrs after vaccine. purpura LE, Buttock, arms with med prolonged. Pt sibling vaccinated as well with same symptoms. May be Henoch Schonlein Purpura.										10/21/2005	10/22/2005	1	Labs Pending /ISA	PVT	UNK		URI	Asthma			1						1	Henoch-Schonlein purpura; Purpura	FLU3~SANOFI PASTEUR~U1763JA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246478	11/01/2005	NY	53.0	53		F	10/17/2005	Pt received vaccination on Sat Oct 15 2005. Pt noticed on morning of Monday Oct 17 that the arm she received the injection in was red and warm to touch. Pt had a nurse at the doctors office she works at look at her arm. Nurse circled the reddened area in order to monitor it. No c/o itching, burning. Small hard local bump notices at area of injection site. Pt being treated for cellulitis with antibiotics.									Y	10/15/2005	10/17/2005	2		PVT	OTH						1						1	Cellulitis; Feeling hot; Injection site hypersensitivity; Injection site induration; Injection site reaction	FLU3~SANOFI PASTEUR~U1804AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246480	11/01/2005	WI	63.0	63		F	10/28/2005	Started with tingling in right arm & fingers. Spitting up phelm than vomiting & diarrhea. Extreme weakness, fever & chills.				Y					Y	10/19/2005	10/19/2005	0	Blood test, urine test	PUB	PVT	Arimidex	NONE	Sulfonamides blaxin			1						1	Asthenia; Chills; Diarrhoea; Paraesthesia; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1744AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246481	11/01/2005	MI	65.0	65		F	10/28/2005	Extreme debilitating continuous pain in right arm (extending from neck to wrist) after pneumonia shot. This lasted 3 days with 4 more days of moderate pain at site of shot									Y	10/21/2005	10/21/2005	0		PUB	OTH	Neoral;Capoten;Bactrim;Calcium;Vitamin C Xanax	NONE	Liver transplant 1988			1						1	Asthenia; Injection site pain; Pain	FLU3~AVENTIS PASTEUR~U1904AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0790P~2~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246482	11/01/2005	OH	50.0	49		F	10/24/2005	Dizziness, chest discomfort, chest pain and bilateral arm pain.									Y	10/16/2005	10/16/2005	0		PUB	PVT		NONE				1						1	Chest discomfort; Chest pain; Dizziness; Pain	FLU3~SANOFI PASTEUR~U1753AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246483	11/01/2005	MI	60.0	60		F	10/28/2005	Entire Rt. deltoid swelled within hours, hardened, locally reddened, patches of red around base of deltoid, hot skin, ache so bad the arm could not be raided for 1 day. Hurt to move it for 2 more days until swelling subsided. Apparent allergic reaction. No fever, duration 4 days.									Y	10/07/2005	10/07/2005	0		OTH	PVT	Atenolol, Actonel, Vytorin, Hyzaar, Xanax	NONE	NONE			1						1	Hypersensitivity; Hypokinesia; Injection site erythema; Injection site induration; Injection site pain; Injection site swelling; Injection site warmth; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U1792AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0791P~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246484	11/01/2005	ID	84.0	83		F	10/28/2005	Patient stated broke out in hives under arm pit and Lt itched and burned left arm.										10/18/2005	10/18/2005	0		OTH	UNK						1						1	Pruritus; Skin burning sensation; Urticaria	FLU3~SANOFI PASTEUR~U1805AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246485	11/01/2005	PA		68		F	10/28/2005	Area around injection site is raised, red warm to the touch, painful, and larger than a half dollar. Advised Tylenol and cold compress. F/U with us with any changes or concerns less than 1% reporting from injection.									U	10/28/2005	10/28/2005	0	NONE	PVT	PVT	Benicar  20/12.5	NONE	Ceftin, Blaxin, Benadryl, Advil, Cold & Sinus liquid meds.			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1824AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246486	11/01/2005	IN	43.0	42		F	10/28/2005	Intense itching to feet and hands @ 1800 hrs. with rash, continuing after 48 hrs. Rash and itching present @ 72 hrs. ED visit with treatment and resolving.				Y					Y	10/24/2005	10/25/2005	1	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U1838AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246487	11/01/2005	IN	38.0	37		F	10/25/2005	4 hrs after vaccination itching & redness at injection site, irritation present also. At 8 hrs shot site 3 diameter of swelling, itching, redness; also sinus congestion and feet itching top of feet bilaterally lasting about 72 hrs.									Y	10/24/2005	10/24/2005	0		PUB	PUB	Yasmin	Denies	None			1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Pruritus; Sinus congestion; Skin irritation	FLU3~SANOFI PASTEUR~U1838AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246488	11/01/2005	MO	6.0	5		F	10/26/2005	5 minutes after getting shot, patient was standing up and suddenly fell back to floor & hit head. Very still, pale, eyes glaring. Lasted 10 seconds 911 called VSS small dime size lump on back of head. Sent to ER for examine.				Y					Y	10/26/2005	10/26/2005	0	NONE	OTH	PVT	NONE		NONE			1						1	Injury; Loss of consciousness; Pallor; Staring	FLU3~SANOFI PASTEUR~U1802AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246489	11/01/2005	CT	51.0	50		F	10/24/2005	40 minutes after flu shot I had severe jerking of arms and legs, fever, confusion. Treaded with forced fluids, 400cc 5 hours and Tylenol. Weak, sleepy times 4 days									Y	10/13/2005	10/13/2005	0		OTH	PVT		NONE	NONE			1						1	Asthenia; Confusional state; Dyskinesia; Pyrexia; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246490	11/01/2005	OH	41.0	40		F	10/25/2005	Severe joint pain in elbows, wrists, fingers, hips,knees, and ankles beginning approx 6 - 7 hrs after FluMist (not certain if related) joints felt internally inflamed. Had difficulty walking due to pain, holding a cup and writing with a pen. Joint pain resolved in 24 hours (did miss work due to the pain). Took Ibuprofen around the clock and applied warm packs to joints.									Y	10/17/2005	10/17/2005	0		OTH	OTH	Micardis HCT		Hypertension			1						1	Arthralgia; Arthritis; Difficulty in walking	FLUN3~MEDIMMUNE VACCINES, INC.~500426~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0246491	11/01/2005	MO	59.0	59		F	10/27/2005	Hot flashes, shortness of breath, restlessness, anxiousness.									Y	10/17/2005	10/17/2005	0		PUB	UNK	NONE	NO	NONE			1						1	Anxiety; Dyspnoea; Hot flush; Restlessness	FLU3~SANOFI PASTEUR~U1775AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246492	11/01/2005	MT	75.0	75		F	10/26/2005	Patient states on 10/20/05, that 5 1/2 hrs after vaccine rapid pulse, chills, discomfort, blood shot eyes, loss of taste. Refuse to see MD - She  has history of racing pulse on meds. Lasting 1 hour. 10/21 states fine sense of taste returning.									Y	10/17/2005	10/17/2005	0	N/A	PUB	PUB	Atenolol and others,  Boniva	NO	UNKNOWN			1						1	Ageusia; Chills; Discomfort; Heart rate increased; Ocular hyperaemia	FLU3~SANOFI PASTEUR~U1905AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246493	11/01/2005	NC	1.25	1	.2	M	10/26/2005	Intense rash beginning 1 week after vaccine. Referred to Dr who diagnosed Serum Sickness.				Y						10/20/2005	10/24/2005	4	CBC normal	PVT	PUB		NONE recorded	Past history of MRSA abscess as infant			1						1	Rash; Serum sickness	FLU3~SANOFI PASTEUR~U1747AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246494	11/01/2005	MN	74.0	74		M	10/21/2005	Fever, cough, body aches for 5 days. Starting a few hours after receiving flu vaccine.				Y					N	10/20/2005	10/21/2005	1	CBC w/diff.	PVT	UNK		NONE	NONE			1						1	Cough; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1832BA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246495	11/01/2005	MN	77.0	76		F	10/25/2005	Fever, body aches, cough, starting a few hours after flu vaccine. Headache.				Y					N	10/12/2005	10/12/2005	0	CBC	PVT	UNK		NONE	NONE			1						1	Cough; Headache; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1832BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246496	11/01/2005	MN	55.0	54		F	10/21/2005	Upper arm has a pink rash from the shoulder to mid arm laterally, no induration, mild ??. No adenopathy in axillary area of supraclavicular area. Arm is mildly tender. Rash is will migrated.									U	09/23/2005	09/24/2005	1	N/A	PVT	PVT	Ambien, Ciprofloxacin,  Climara, hydroc ??	Pertussis				1						1	Rash; Tenderness	BCG~SANOFI PASTEUR~U1596DA~UNK~IM~RA~BCG (MYCOBAX)~1|FLU3~SANOFI PASTEUR~U756AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHABA026AC~1~IM~LA~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHABA026AC~1~IM~LA~HEP A (HAVRIX)~1	USA		Influenza
0246497	11/01/2005	VT	94.0	94		M	10/27/2005	Shot on Friday- Friday night had fever 101.6 degrees. Slept most of Saturday - part of Sunday fever 99.5 degrees. Still not feel well 10/27/05 - onset of cold, perfect before flu shot									N	10/21/2005	10/22/2005	1		PUB	OTH						1						1	Pyrexia; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246498	11/01/2005	HI	42.0	42		M	10/27/2005	Left arm swelling x 3 days. Resolved on own.									Y	09/27/2005	09/28/2005	1		PUB	PVT			asthma			1						1	Swelling	FLU3~SANOFI PASTEUR~U1754AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0706P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246499	11/01/2005	MI	30.0	30		F	10/25/2005	Received flu shot 4 pm. At 7 pm for half hour had irresistible urge to cough. 7:30 felt throat swelling, developed metallic taste and joints ached. Called nurse thru poison control. She advised ER but patient just stayed home and took benadryl. Joint aching resolved in a couple hours. Metallic taste lasted into next day and sereation of swollen throat resolved next day.									Y	10/21/2005	10/21/2005	0		PUB	UNK		NONE	NONE		MI2005041	1						1	Arthralgia; Cough; Dysgeusia; Pharyngeal oedema	FLU3~SANOFI PASTEUR~U1836AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246500	11/01/2005	MN	27.0	27		F	10/25/2005	2 week hx of cough, bodyaches, headache, fever starting day post flu vaccine.				Y					N	10/04/2005	10/04/2005	0	CAC	PVT	UNK						1						1	Cough; Headache; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1761AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246501	11/01/2005	IL	68.0	68		M	10/26/2005	Pain, swelling from left shoulder to elbow, redness, warm to touch at vaccination site, dime size hive like rash										10/25/2005	10/26/2005	1		PUB	UNK						1						1	Feeling hot; Injection site erythema; Pain; Rash; Swelling	FLU3~SANOFI PASTEUR~U1814AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246502	11/01/2005	IL	71.0	71		F	10/20/2005	Extreme soreness in arm extending 2.5 inches below shoulder (injection site) lasting about 2 weeks. Patient describes difficulty with normal activities due to soreness									U	10/04/2005	10/04/2005	0		OTH	PVT						1						1	Injection site pain	FLU3~SANOFI PASTEUR~U1806AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0605P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246503	11/01/2005	WY	79.0	79		F	10/29/2005	Aches and pains in all joints. Hoarseness. Lost voice for 4 or 5 days. Weakness/tiredness breathing problems									Y	10/11/2005	10/11/2005	0		OTH	PUB	ADVAIR, SINGULAIR, Lorazepam	Was fine				1						1	Arthralgia; Asthenia; Dysphonia; Fatigue; Respiratory disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246506	11/01/2005	FL	2.0	2	.1	M	11/01/2005	Fever, redness, tenderness at site (right thigh). Symptoms occurred 12-24 hours later. No generalized symptoms except fever.				Y					Y	10/25/2005	10/26/2005	1		PVT	UNK						1						1	Injection site erythema; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~U1743KA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~1808627F~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0246507	11/01/2005	MA	51.0	51		M	10/31/2005	Arm very sore and hot got red by midnight. On Sunday felt malaise, tired, fever climbed to 102.5 degrees. Monday morning had to drink lots of fluids, almost passed out on couch. Went to doctor and got chest x-rays and ekg which came back with white cell blood count elevated. On Monday blacked out while driving 3 times on way home. Tuesday had another doctor visit and doctor considered sending him to cardiologist and prescribing antibiotics for possible infection.  On Sunday also had stiff neck mostly on right side and joint aches mainly on Sunday. Today doing well, slightly red at injection site. Asthma condition worsen during this period so had to use the inhaler more often.				Y					Y	10/22/2005	10/22/2005	0		PVT	PUB	prednisone, lithium, zyprexa, flonase, zyrtec, protonix, accolate, zestin, methylgen, amiex, albuterol inhaler, wellbutrin		asthma, stomach problems, latex sensitive, rosacea,			1						1	Arthralgia; Asthma; Fatigue; Feeling hot; Infection; Injection site erythema; Loss of consciousness; Malaise; Musculoskeletal stiffness; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0246508	11/01/2005	GA	72.0	72		F	10/31/2005	Red and hot band on left arm, with swelling for 9 days. Also extended to underarm are to the point that arm was immobile due to the swelling. Didn't have any fever.				Y					Y	10/02/2005	10/02/2005	0		OTH	PUB	Imodium					1						1	Cellulitis; Feeling hot; Joint range of motion decreased; Swelling	FLU3~SANOFI PASTEUR~U177AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~07497~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246510	11/01/2005	AR	40.0	40		F	10/06/2005	Sore throat (Pharyngolaryngeal pain), Nasal congestion, muscle ache (Myalgia), chills, sinus pressure (sinus headache), Headache									Y	09/28/2005	09/29/2005	1		PVT	PVT	Zoloft				MEDI0003720	1						1	Chills; Headache; Myalgia; Nasal congestion; Pharyngolaryngeal pain; Sinus headache	FLUN3~MEDIMMUNE VACCINES, INC.~UNK~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0246511	11/01/2005	IA	42.0			F	10/03/2005	Sore throat (pharyngolaryngeal pain), muscle pain (myalgia).									U	09/28/2005	09/29/2005	1		OTH	OTH	Effexor	Rosacea			MEDI0003722	1						1	Myalgia; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~UNK~1~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0246512	11/01/2005	TX	6.0	5		F		Medication error (medication error), Redness of eyes (ocular hyperemia), Pain eye (eye pain), tearing eyes (lacrimation increased).									Y	09/26/2005	09/26/2005	0		PVT	OTH	Concomitant drug not reported.				MEDI0003706	1						1	Eye pain; Lacrimation increased; Medication error; Ocular hyperaemia	FLUN3~MEDIMMUNE VACCINES, INC.~500389P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0246513	11/01/2005	MA	5.0	5		M	10/31/2005	Pt came in for 5 yr WCC. Vacaine's DTaP #5 IPV #4 MMR #2 as well as influenza .05cc were administered. Pt 10 min later developed wheezing, dyspnea and tightness of chest				Y					Y	10/28/2005	10/28/2005	0		PVT	PUB	singulair, albuterol MDI		asthma			1						1	Chest discomfort; Dyspnoea; Wheezing	DTAP~SANOFI PASTEUR~U1349DA~5~IM~~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y02982~4~SC~~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0031R~2~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0246514	11/01/2005	IN	3.0	2	.6	F	10/31/2005	6 cm x 6 cm red raised area with punctate needle mark in the center									Y	10/28/2005	10/29/2005	1		PVT	PVT						1						1	Injection site swelling; Rash erythematous	FLU3~SANOFI PASTEUR~U1905AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246515	11/01/2005	NJ	16.0	15		M	11/01/2005	10/24- Numbness of tongue & headache 5 pm. 10/25-School nurse called, numbness of the right side of face. Took patient to the doctor diagnosis, was Belle's Palsy 12 pm. Blood test ordered for Lyme. 02/06/07-records received and reviewed: DX Bell's Palsy on 10/25/05 11/7/05-doing better but still complains of right ear pain with intermitten throbbing.				Y					N	10/21/2005	10/24/2005	3	Blood Test, Lyme, Negative	PVT	UNK	Maxair Inhaler	NONE	Asthma			1						1	Facial palsy; Headache; Hypoaesthesia; Tongue paralysis; Facial palsy	FLU3~SANOFI PASTEUR~U1850AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1821AA~1~IM~~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|FLU3~SANOFI PASTEUR~U1850AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|MNQ~SANOFI PASTEUR~U1821AA~1~IM~~MENINGOCOCCAL CONJUGATE (MENACTRA)~2	USA	Emergency room visit	Influenza
0246525	11/01/2005	PA	12.0	11		M	10/26/2005	Child given vaccine not indicated for age Infanrix given instead of Boostrix.										10/26/2005	10/26/2005	0		PVT	PVT		NONE	Eczema			1						1	Medication error	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14A000913A~6~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1930AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|JEV~SANOFI PASTEUR~U1722AA~1~IM~RA~JAPANESE ENCEPHALITIS (JE-VAX)~1	USA		Influenza
0246553	11/01/2005	SC	38.0	37		F	11/01/2005	Lesion (approx. size 1/8x1/2) on arm about 2 1/2 from site of injection.  No other obvious trauma to area.										10/31/2005	11/01/2005	1		UNK	UNK	Topomax; Ortho Evera	None	none			1						1	Skin ulcer	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246555	11/01/2005	KS	54.0	54		F	11/01/2005	Approx 7 hours after vaccine awoke 9:30 PM with uncontrollable shaking, chills, fever, shortness of breath, weakness, and wheezing. Given 2 extra strength Tylenol. Around 2:30 AM, 5 hours later symptoms receded. After awakening around 7AM, still have weakness, and general ill feeling.									Y	10/31/2005	10/31/2005	0		UNK	UNK						1						1	Asthenia; Chills; Dyspnoea; Malaise; Pyrexia; Tremor; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246556	11/01/2005	PA	86.0	86		F	11/01/2005	Right arm red and edemetous, skin warm to touch.									Y	10/15/2005	10/16/2005	1		UNK	UNK	eye drops, dexamethasone, lorazepam, Protonix, Zofran, acetylcysteine, IV dextrose solution	two week history nausea, abdominal pain, emesis. clinically dehydrated. new epigastric mass.	breast carcinoma treated with lumpectomy and clinically stable. degenerative joint disease. history of infectious diarrhea. herpetic zoster.  chronic thrombocytosis secondary to myelofibrotic syndrome. osteoporosis with a prior vertebral compression fracture. may have underlying myelofibrotic syndrome. has mild spinal stenosis. generalized debilitation.			1						1	Injection site erythema; Injection site oedema; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA122AB~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0607R~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246557	11/01/2005	CA	76.0	76		F	11/01/2005	Received vaccine during public innoculation on Friday 10-21-2005.  Flu-like symptoms began on Sunday, and by late Monday experienced alternate chills and fever.  Monday night great difficulty sleeping because of fever and chills.  Was able to get up and function Tuesday, but with difficulty and discomfort.  Patient has had similar reaction to public (clinic administered) flu shots in past years.									Y	10/28/2005	10/29/2005	1		UNK	UNK		none	none			1						1	Chills; Discomfort; Influenza like illness; Insomnia; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0246558	11/01/2005	MI	56.0	56		F	11/01/2005	Patient received the influenza vaccination on 10/24/2005.  She work up that evening with red welts and burning and itching on her left arm around the site of the injection.  The next day she developed welts and generatlized itching in the groin, anal area, back and bilateral arms.  Had three episodes of shortness of breath which prompted breathing treatments which helped the symptoms resolve.									Y	10/24/2005	10/24/2005	0		UNK	UNK	Allegra	None	Asthma, multiple allergies			1						1	Dyspnoea; Injection site erythema; Pruritus genital; Thermal burn; Urticaria	FLU3~SANOFI PASTEUR~U1823AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246559	11/01/2005	OH	72.0	72		F	11/01/2005	Red rash, itchy, raised blisters around the injection site. The area turned very dry and itchy, approx. 3 weeks.									Y	10/20/2005	10/20/2005	0		UNK	UNK	Coumadin		Artial Fibrillation			1						1	Dry skin; Injection site hypersensitivity; Injection site rash; Injection site vesicles; Pruritus	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0246561	11/01/2005	UT	53.0	53		F	11/01/2005	Immunization took place Wednesday, 26 Oct 2005 approx 5:30 PM. I felt fine during the rest of the evening. By early Thursday morning (27 Oct 05)I noticed my bottom lip seemed to be swollen as if I had a hive on it then at about 9:00 AM my voice became very hoarse which I thought was very strange, then my voice faded in and out,also with increased asthma difficulties. My voice is still raspy and fades in and out. My asthma is still troublesome as of todays date is 1 Nov 05. I felt that since the hoarseness is still me and asthma difficulties, I felt it was best that I contact your office about it. I do't have any idea how much longer this will last I'm hoping it goes away soon? I did not go to a doctor for it, I have been taking Benadryl to counter the reaction from it and primateen for the asthma.  I have had Flu Immunizations for years and this is the first time I have had any kind of reaction to it,which was another odd thing about this. My lip still is swollen but not big enough to create attention to it.									N	10/26/2005	10/27/2005	1	None at this point	UNK	UNK	Primateen Benedryl Bayer Asprin	Asthma	Asthma Sinus Allergies			1						1	Asthma; Condition aggravated; Dysphonia; Face oedema; Urticaria	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246562	11/01/2005	OH	78.0	77		M	11/01/2005	Shot given in upper R. arm on Thursday.  Below the elbow a lump appeared the next day, the size of a fist.  My arm was swollen and inflamed from the elbow to the wrist on the inside of the arm.  The area was very tender and painful. The elbow was very painful on Friday, tried call with no reply.  Called again on Sat. and was told to use Tylenol for the pain and see the Dr. on Monday.  Dr. suggested not to get flu shots. On the 24th a visit to Pre Admission for Surgery for hernia, and the Drs. were concerned about the arm.  I took approx. 10 days for the arm to return to normal.				Y					Y	10/20/2005	10/21/2005	1		UNK	UNK						1						1	Injection site inflammation; Injection site mass; Pain; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246563	11/01/2005	NM	0.62	0	.6	M	11/01/2005	I told the doctor I thought my son had a cold that he had a runny nose. He said it really wouldn't matter. That he didn't seem sick. His nurse gave him the flu shot any way. That night he woke up really hot. I gave him some tylenol. He was wheezing and having problems breathing. So I put the Vaporizer on. In the morning I sent him to the sitter. She called at 10 saying he wasn't brathing right. I had my dad go pick him up and meet me. I called his doctors office they said they couldn't get him in till 1:30. I told him we wouldn't wait that long. So we took him to the emergency room. The doctor said he had croup. I told him he had got a flu shot, that didn't seem to matter or he didn't think it was a side effect from the shot. He gave us a steroid prescription. Today 6 days later he is fianally feeling better.				Y					Y	10/26/2005				UNK	UNK		cold				1						1	Croup infectious; Dyspnoea; Feeling hot; Rhinorrhoea; Wheezing	FLUX~UNKNOWN MANUFACTURER~~1~~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0246564	11/01/2005	TN	49.0	49		F	11/01/2005	Immunized at 1245 pm. Within a few minutes, my throat was swollen.(no prob breathing) Within 2-3 hours, I felt like there was water in my lungs. At about 4 hours, I couldn't stop coughing, wheezing. It sounded like I was barking. My eyes were very swollen and became very inflamed with discharge. My was swelling as well to a little lesser degree. I had a low grade fever, 99.9 and in the next hours had chills, and nausea-no vomiting. The following day, I felt achy and cold,I took an antihistamine and my eyes became less swollen by evening. Most of symptoms disappeared within 48 hours except for intermittent intense headaches, mild nausea in the evenings and intermittent pain on my rt side and general malaise. (I've taken the flu shot on many occasions with no adverse reactions)									N	10/27/2005	10/27/2005	0	none	UNK	UNK	none	none	sulfa			1						1	Chills; Cough; Eye discharge; Eye inflammation; Eye swelling; Feeling cold; Headache; Malaise; Nausea; Pain; Pharyngeal oedema; Pyrexia; Wheezing; Cough; Dyspnoea; Face oedema; Ocular hyperaemia; Pain; Pharyngeal oedema; Pruritus; Pulmonary congestion; Pyrexia	FLU3~SANOFI PASTEUR~u1838aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1838AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0246567	11/01/2005	DE	4.0	4		F	11/01/2005	Vaccine administered on 10/20/05 @0745 Per notes in chart: pt vomiting thick mucous & large amount of big yellow stool; Sats decreased to 93-94% and BP 80-90's/50-60's on 10/20/05 @0845 Solu-medrol 20mg IV and Benadryl 10mg IV given @0930 Hives noted by nurse									Y	10/20/2005	10/20/2005	0		UNK	UNK						1						1	Faeces pale; Urticaria; Vomiting	FLU3~SANOFI PASTEUR~U1823AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246568	11/01/2005	FL	53.0	53		M	11/01/2005	Patient reported increased spasticity and some increased shortness of breath 1 week after receiving immunization.									Y	10/18/2005	10/31/2005	13	None	UNK	UNK	GLOVE VINYL SMALL NONSTERILE - USE GLOVE    AS DIRECTED  MIRTAZAPINE 30MG TAB - TAKE ONE-HALF TABLET BY MOUTH AT BEDTIME FOR MOOD AND APPETITE  TABLET CUTTER, POCKET SIZE - USE DEVICE    AS DIRECTED TO SPLIT TABLETS  TOPIRAMATE 100MG TAB -	None	Flexeril- nausea ------                                    17 Active Problems PROBLEM                                           LAST MOD    PROVIDER Pain and swelling or deformity in only 2-4 joints (ICD 799.9)       09/20/2005       Cholecystectomy (ICD 799.9)                       09/10/2005         In past Contracture (ICD 799.9)                           09/10/2005         Elbow flexion Decubitus Ulcer (ICD 799.9)                       09/10/2005         History of with skin flap repair on coccyx UTI (ICD 599.0)                                   09/10/2005         Frequent with various organisms Bladder, Neurogenic (ICD 596.54)                  09/10/2005         Urodynamic studies-3/04- absent sensation, high pressure det Osteopenia (ICD 733.90)                           09/10/2005   Neck Pain (ICD 723.1)                             09/10/2005         Due to kyphoscoliosis yphoscoliosis and scoliosis (ICD 737.39)         09/10/2005   Greenfield filter internal (ICD 799.9)            09/10/2005   FAMILY CIRCUMSTANCES NEC (ICD V61.8); Other family prblm      08/10/2005       ECONOMIC PROBLEM (ICD V60.2); Financial issues    08/10/2005   HOME REMOTE FROM HOSPITAL Transportation issue (ICD V63.0);             08/10/2005       HEPATITIS C CARRIER (ICD V02.62); Hepatitis C carrier 1b genotype 09/10/2005     (ICD-9-CM V02.62)  QUADRIPLEGIA, UNSP (ICD 344.00); Quadriplegia *   01/21/2005     (ICD-9-CM 344.00)  DYSTHYMIC DISORDER (ICD 300.4); Dysthymic Disorder (ICD-9-CM 300.4)        01/21/2005       CONSTIPATION, unspecified (ICD 564.00)            09/13/2005			1						1	Dyspnoea; Muscle spasticity	FLU3~SANOFI PASTEUR~U1762AA~3~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246570	11/01/2005	CA	34.0	34		F	11/01/2005	Developed a rash (approximately 3 inches in size)at the injection site.  Also suffered from fever, headaches, and lightheadedness.									Y	10/27/2005	10/27/2005	0	None.	UNK	UNK	Aldomet, 100 mg/twice daily	None.	Hypertension			1						1	Dizziness; Headache; Injection site rash; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246571	11/01/2005	OH	30.0	30		M	11/01/2005	Approximately 3 hours after injection I had the following symptoms: difficulty breathing, cold sweat, body aches and weakness. Then in another two hours turned into severe nausea, dizziness. Symptoms lasted 12 to 15 hours. Was very close to going to the emergency room when I fell asleep.									Y	10/25/2005	10/25/2005	0		UNK	UNK	none	none				1						1	Asthenia; Dizziness; Dyspnoea; Hyperhidrosis; Nausea; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246572	11/01/2005	FL	59.0			M	11/01/2005	Patient had Flu vaccine and Pneumonia vaccination in same arm on 10/11/2005 at a local grocery store. Seen my office 10/13/2005 with severe reaction at site of injection. Treated with steroid orally and local measures				Y					Y	10/11/2005	10/12/2005	1		UNK	UNK	Flonase, Prevacid, tagamet, aspirin	none	insects, Singulair(hives)			1						1	Injection site reaction	FLU3~SANOFI PASTEUR~u1793AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749p~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246573	11/01/2005	CO	66.0	65		M	11/01/2005	had flu shot on Oct 19, became sick with flu on Oct 22, rather severe, sore throat, fever, headache, unable to eat for 24 hours.									Y	10/19/2005	10/22/2005	3		UNK	UNK						1						1	Anorexia; Headache; Influenza; Pharyngolaryngeal pain; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0246574	11/01/2005	NV	41.0	40		F	11/01/2005	Client experienced facial tingling - 5 minuest after immunization - predominently on the right side. Given 50mg Benedrly P.O. 10 minutes after immunization. Vital signs stable. Hx: allergy to iodine - anaphylaxis. Tingling decreased by 30 minutes following the event. Client's vital signs remained stable. Client instructed to follow-up in the ER if client experienced difficulty breathing or tingling returned.									Y	11/01/2005	11/01/2005	0	Vital signs. Immunization given at 1025 1030 BP: 110/90 P:56 1050 BP: 110/85 P:56	UNK	UNK	UNK	None	UNK HX Anaphylactic Reaction to Iodine			1						1	Paraesthesia	FLU3~SANOFI PASTEUR~U1807AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246578	11/01/2005	NC	50.0	49		F	11/01/2005	Shot administered on 10/22/05. Redness at injection site on posterior upper L arm began next day. Diagnosed with cellulitis on 10/27/05. Started on oral cef..  Recheck on 10/31/05 showed vast improvement. Will complete 7-day course				Y					Y	10/22/2005	10/23/2005	1		PVT	OTH	NONE  At present sulfate	NONE	PCN, Darvon, Demerol. Borderline DM, TBS, Thyroid obesity			1						1	Cellulitis; Injection site erythema	FLU3~SANOFI PASTEUR~U1763AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246579	11/01/2005	NJ	32.0	32		F	11/01/2005	Rash on neck, back, arms, within 18 hours. Then progressed to torso and thighs within 5 days. 12/04 shows mild rash.				Y					Y	10/26/2005	10/27/2005	1		PVT	UNK	NONE	NONE	Merthiolate	~Influenza (Seasonal) (Fluzone)~1~31.00~In Patient		1						1	Rash	FLU3~SANOFI PASTEUR~U1819AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246581	11/01/2005	MA	41.0	41		F	10/27/2005	Developed inability to swallow solid food 10/28/05 which worsened by 10/27/05 and is now having trouble swallowing liquids. Went to hospital walk in 10/27/05. Given prednisone 20 mg TID for 3 days and Pepcid. Not started as of this writing.				Y					Y	10/24/2005	10/25/2005	1		PUB	PUB	Gythroin Zannax	NONE	Bronchitis			1						1	Dysphagia	FLU3~SANOFI PASTEUR~U1854AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246582	11/01/2005	MA	56.0	55		F	11/01/2005	Injection site felt like Bee Sting while driving home. Upper arm was tingly, warm to touch. Red, swollen and itchy 15 minutes after injection. Eventually redness went from shoulder  to elbow. Seen at hospital and given prednisone and Atarax at 9:30 am				Y					Y	10/26/2005	10/26/2005	0		PUB	PUB	Lipitor	NONE	Chronic Bronchitis, High Cholesterol			1						1	Erythema; Feeling hot; Injection site reaction; Paraesthesia; Pruritus	FLU3~SANOFI PASTEUR~U1854AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246583	11/01/2005	MA	63.0	63		M	10/02/2005	Swelling, redness of right arm 7 hours after shot. Arm very painful, unable to sleep. Blurry vision. To P.C.P in am of 10/27 - ordered ice pack only. Went to hospital 10 am 10/27/05 was given prednisone taper pack				Y					Y	10/26/2005	10/26/2005	0		PUB	PUB	Celexa, Lisinopril, HCTZ Vitamin	NONE	Asbestosis			1						1	Erythema; Insomnia; Oedema; Pain; Vision blurred	FLU3~SANOFI PASTEUR~U1854AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246584	11/01/2005	OR	62.0	61		F	10/31/2005	Red swollen area on arm less than 4 inches. Low grade fever 99 degrees F.									U	10/28/2005	10/29/2005	1		OTH	PVT		Light fever, red arm				1						1	Erythema; Oedema; Pyrexia	FLU3~SANOFI PASTEUR~1848AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577P~2~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246585	11/01/2005	CA	10.0	9		F	10/31/2005	Had flu immunization 10/28/05 next day her RUE shakes when she extends her arm. Also complained pain R deltoid and antecubital area, no numbness no area change. No febrile										10/28/2005	10/29/2005	1	NONE	PVT	UNK	NONE	NONE				1						1	Pain; Tremor	FLU3~SANOFI PASTEUR~U1864AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246601	11/01/2005	IL	76.0			F	11/01/2005	This case was reported by a pharmacist and described the occurrence of elevated red blood cell count in a 76 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On Oct 20 2005 the subject received a dose of Fluarix (lot AFLUA1200AA). the pharmacist did not report a previous history of vaccination to influenza virus. On Oct 21 2005, one day following vaccination with Fluarix, the subject experienced an elevated red blood cell count, leg weakness, a high fever and pain throughout her body. The subject was hospitalized on Oct 24 2005 for testing. The events were ongoing at the time of initial reporting, Oct 31 2005. The pharmacist considered the events to possibly be related to vaccination with Fluarix, The pharmacist also stated that , no cause has been determined for her symptoms other than the patient had received the flu vaccine the previous day.					Y	0			N	10/20/2005	10/21/2005	1	Body temperature 10/21/2005 fever, Red blood cell count 10/21/2005 high.	OTH	PVT					A0580343A	1						1	Asthenia; Pain; Pyrexia; Red blood cell abnormality	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA120AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0246515	11/02/2005	NJ	16.0	15		M	11/01/2005	Pt vaccinated 10/21/05 without difficulty with Flu and Menactra. returned to office 10/25/05 with Bell's palsy.									N	10/21/2005	10/25/2005	4	Lyme Titer	PVT	PVT	Mcvair	NONE known	Asthma			1						2	Facial palsy; Headache; Hypoaesthesia; Tongue paralysis; Facial palsy	FLU3~SANOFI PASTEUR~U1850AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1821AA~1~IM~~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|FLU3~SANOFI PASTEUR~U1850AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|MNQ~SANOFI PASTEUR~U1821AA~1~IM~~MENINGOCOCCAL CONJUGATE (MENACTRA)~2	USA		Influenza
0246575	11/02/2005	VA	50.0	50		F	11/02/2005	Influenza Vaccine given SQ.  Local reaction w/ 10 cm of indurated erythema developed around injection site.  This reaction persisted for ~ 7 days.									Y	10/13/2005	10/14/2005	1	none	UNK	UNK	Insulin Zocor Cozaar Enabelex	Type 1 Diabetes	Type 1 diabetes PCN allergic			1						1	Injection site erythema; Injection site induration; Injection site reaction; Erythema; Feeling hot; Rash papular; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA160AF~1~SC~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA143AD~UNK~SC~~INFLUENZA (SEASONAL) (FLUARIX)~2	USA		Influenza
0246577	11/02/2005	CA	24.0	24		F	11/01/2005	Call received day after receiving above vaccines re: nausea/vomiting and diarrhea, 10-15 hours after receiving above vaccines.									Y	10/31/2005	10/31/2005	0		PVT	PVT	OCP	NONE	Seasonal allergies, environmental allergies, cat dander			1						1	Diarrhoea; Nausea; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU122RA~2~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~MERCK & CO. INC.~05C4R02~1~IM~~HEP B (RECOMBIVAX HB)~1	USA		Influenza
0246609	11/02/2005	AL	1.25	1	.2	F	11/02/2005	Febrile Seizure lasting about 5 min evaluated in ER then DCd. No known family hx of seizure. Given Motrin in ER and seizure info in office.				Y					Y	11/01/2005	11/02/2005	1		PVT	PVT		Cold and diarrhea				1						1	Febrile convulsion	DTAP~SANOFI PASTEUR~C2220AA~4~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1743MA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0410P~2~IM~RL~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~A94451H~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0246610	11/02/2005	WA	38.0			F	10/13/2005	A non serious spontaneous case from a nurse involving Papular rash around eyes. The reporter causality is possibly related to FluMist. This case is submitted according to the VAERS safety surveillance accelerated reporting agreement with FluMist. A nurse practitioner reported that a 38 year old female patient experienced non pruritic papular rash around both eyes, back pain and maxillofacial edema, one day after she received FluMist on Oct 6 2005. No accompanying shortness of breath was noted. per the reporter, symptoms presented were not consistent with angioedema. She went back to the clinic ans was prescribed with oral Benadryl (Diphenhydramine), ranitidine, Motrin (ibuprofen) and Percocet (acetaminophen/oxycodone). Complete blood count and urinalysis were done, both of which were within normal. As of Oct 21 2005, the patient has completely recovered from adverse events reported. The reporter assessed the events as possibly related to FluMist.									Y	10/06/2005	10/07/2005	1	CBC and Urinalysis normal	MIL	MIL			Allergy to formaldehyde		MEDI003736	1						1	Back pain; Face oedema; Rash papular	FLUN3~MEDIMMUNE VACCINES, INC.~500387P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0246611	11/02/2005	MI	43.0	43		F	10/20/2005	Localized reaction to flu vaccine: redness 3 1/2 cm and swelling, slightly warm to the area. To ice area and return if symptoms become worse.									Y	10/18/2005	10/18/2005	0	None	PVT	UNK	ZYRTEC; ADVAIR; SINGULAIR; FLONASE	None	BACTRIM; Amoxicillin; Latex; Asthma			1						1	Feeling hot; Injection site hypersensitivity; Injection site oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA151AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246612	11/02/2005	FL	58.0	57		F	10/27/2005	Vaccine given 10:00 am on 10/21/2005 began with pain in left elbow about 4 hours after injection. Took Tylenol deltoid area became hot, hard and painful at some time as the elbow started hurting waited 4 hours took Motrin. Next day pain continued. On Sunday used compresses went to ER on Sunday did EKG, lab test, all test were normal. Given antiinflammatory (Motrin) and Percocet.				Y					Y	10/21/2005	10/21/2005	0	EKG, Lab test were normal	PVT	PVT	Spiro do ketones, Monopril, Lipitor	NONE	Hypertension			1						1	Feeling hot; Injection site induration; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA145BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0246613	11/02/2005	VA	12.0	12		F	10/31/2005	Patient received vaccines on10/28/2005 right arm swollen to quarter size, left arm swollen to about soft ball size. Denies any redness , soreness on and off with movement. Mom called office 10/31/2005 to report symptoms that started on 10/29/2005									U	10/28/2005	10/29/2005	1		PVT	PVT	NONE		NONE			1						1	Oedema; Pain	FLU3~SANOFI PASTEUR~U1824AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2341AA~1~IM~~TDAP (ADACEL)~1	USA		Influenza
0246614	11/02/2005	MA	74.0	74		F	10/31/2005	Hives all over body starting Sat Oct 29 , blisters left wrist area Sat Oct 29am, Sun night took antihistamine call info MD await return.									N	10/27/2005	10/29/2005	2		PUB	PVT	Calcium Vita D, theodor, Lisinopril, Darvocet, Tylenol, Fosamax, Clycolax, Protonix, Klorcon, Prednisone, MVI, Pospire, HH Nebulizer with albuterol, Flovent.	NONE	Stroke April 2005			1						1	Blister; Urticaria	FLU3~SANOFI PASTEUR~1755AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246615	11/02/2005	MN	1.01	1	.0	F		Unusual fussiness for 1 week, then measle type rash.				Y						10/19/2005	10/19/2005	0		PVT	PVT	NONE	NONE	Unremarkable history			1						1	Irritability; Rash morbilliform	FLU3~SANOFI PASTEUR~U1765BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0544R~2~IM~RL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0603R~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0626R~1~IM~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0246616	11/02/2005	WA	66.0	65		M	10/28/2005	Hives, pruritus left arm 2 days after injection treated with cool compress, Benadryl, lotrisone cream.				Y					Y	10/20/2005	10/22/2005	2		PVT	UNK			Penicillin allergy			1						1	Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA127AB~UNK~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0790P~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246617	11/02/2005	NJ	42.0	42		M	10/28/2005	Received vaccine at approximately 11am. At 7pm that same night, employee c/o sweating profusely with uncontrollable chills along with muscle cramps (legs and feet). C/o feeling extremely weak and felt he would pass out. At midnight, he felt a migrating heat from chest to back and down to scrotum. He fell asleep at 2am.									Y	10/27/2005	10/27/2005	0		PUB	UNK	Diovan, baby aspirin,	NONE	Hypertension, congenital low spine deformity, cross renal ectopic kidney.			1						1	Asthenia; Chills; Dizziness; Hyperhidrosis; Muscle spasms; Pyrexia	FLU3~SANOFI PASTEUR~U1904AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246624	11/02/2005	MD	17.0	16		F	11/02/2005	At 11:45 ct. developed rash on arms, neck and inside of mouth near back of throat. Went to school nurse who told her to wash up and return to class.  Rash described as itching badly, red raised spots with white bump in middle.  Hot flashes no fever.  Ct's mother called writer at 3:40 PM and described SX. Writer advised her to take Benydryl (ct. states itching was somewhat relieved and rash improved) and take ct. to ED and if any breathing difficulties call 911.  Ct. saw pediatrician who examined her and sent home.  At 11:00 PM ct. developed severe headache and severe nausea. Pediatrician sent to local ED.   Itching relieved w/ Benydryl 25 mg.  at home 4:00 PM.  Emergency Dept. - Ultraset for HA, Phenegren for nausea and more Benydryl. 11/2, 10:00 AM - rash resolved, slight HA, slight nausea, resting comfortably.				Y					Y	11/01/2005	11/01/2005	0	None.	UNK	UNK	Zyrtec Zantac   Midrin	Rhinitis due to allergy.	Seasonal allergies			1						1	Headache; Hot flush; Nausea; Pruritus; Rash; Rash erythematous	FLUN3~MEDIMMUNE VACCINES, INC.~500392P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0246627	11/02/2005	SC	75.0	75		F	11/02/2005	Patient complained of puffed up arm night of flu shot (10/20/05).  Patient used frozen vegetables as cold compress.  No meds taken for pain.  Next AM on 10/21, patient checked arm for swelling.  None noted. patient then noticed red, raised areas/whelps on upper 1-2 inches of palm of right hand and 3-4 inches of right.  10/22/05 and 10/23/05:  The whelps continued to spread up right forearm from palm of right hand to 6 inches below armpit. No pain or itching.  Patient states that most recent whelps burn and are hot.  Patient has used rubbing alcohol topically but denies any meds just for pain.  Patient denies any new medications, foods, contact with plants or recent yardwork.  Patient has approximate 10 year history of flu vaccination without problems.  RN encouraged patient to see PMD and to use Benadryl and cool compresses for relief at present time. NOTE:  RN followed up with patient on 10/28/05.  Patient stated he saw MD on 10/25/05.  Initial diagnosis from MD was allergic reaction?  After conferring with 2nd MD, the first MD changed diagnosis to ?shingles?  Patient was prescribed Famvir, Benadryl, and Caldyphen.  patient was instructed to return 11/01/05 if no relief with meds.  Patient stated as of 10/28, no symptom relief.				Y					U	10/20/2005	10/20/2005	0	NONE	UNK	UNK	Plavix, Folbic, Niaspin, Folmax, Crestor, Metroprolol, Zoloft	NONE	Hyperlipidemia, Hypertension		SC0522	1						1	Injection site erythema; Injection site swelling; Swelling; Urticaria	FLU3~SANOFI PASTEUR~U1819AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246628	11/02/2005	NY	50.0	49		F	11/02/2005	Employee states she started to experience fatigue, positional vertigo within 24 hours of vaccination. Continued to feel dizzy and was seen by her PMD. Employee states doctor feels that the flu vaccine exacerbated previous condition of vertigo. Employee was diagnosed with HTN (consistant with finding in exam by NP in employee health office: see section 9 of this form) and was given a Rx for Hydrochlorothiazide.				Y					Y	10/22/2005	10/22/2005	0	Physical exam by NP in office: right ear canal conpletely occluded with cerumen. BP 148/88 Possible benign positional vertigo, HTN. Employee followed up with visit to her PMD (see section 7 of this form)	UNK	UNK	Pulmicort Inhaler Seravent Inhaler	None	Ashtma Benign Positional Vertigo			1						1	Condition aggravated; Fatigue; Hypertension; Vertigo	FLU3~SANOFI PASTEUR~1833BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246629	11/02/2005	TX	33.0	33		M	11/02/2005	Six hours after vaccine administered, patient started with high fever 102, nausea,vomitting, diarrhea, rapid heart beat.  Lost 11 lbs due to diarrhea/vomitting overnight.  Only treatment was bedrest.									Y	11/01/2005	11/01/2005	0		UNK	UNK		None	None			1						1	Diarrhoea; Heart rate increased; Nausea; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~61319~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246632	11/02/2005	VT	13.0	13		F	11/02/2005	Patient vaccinated between 10am-1 Pm on October 30, 2005. Found dead in bed next morning at home by parents. Pt had type 1 diabetes with AC1 of 7.0 but having hypoglycemic episodes  1-2 times per week and not wanting to treat the symptoms per endocrinlogist.  Term of DM removed from symtom list as per autopsy report rec'd 12/28/2005/sr This is tag-2 report.	Y	10/30/2005							N	10/29/2005	10/30/2005	1	Autopsy being performed	UNK	UNK	Insulin: Lentis 33 U BF Humulog B, L, D sliding scale	NONE	type 1 diabetes onset 7/03		VT200510302005	1						1	Diabetes mellitus; Hyperglycaemia; Hypoglycaemia	FLU3~SANOFI PASTEUR~U1823AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0246634	11/02/2005	IL	50.0	50		F	11/02/2005	Left arm swelling and redness at injection site and extending distally. Discomfort and warmth at the site.Seen by own Md who suggested she show to health dept staff.				Y					Y	10/31/2005	11/02/2005	2		UNK	UNK						1						1	Discomfort; Injection site erythema; Injection site swelling; Injection site warmth	FLU3~EVANS VACCINES~61323~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0790P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246635	11/02/2005	IL	78.0	77		F	11/02/2005	Received Pneumovax vaccine 10/28/05.  Approximately 4 hours after vaccination, she noticed redness and soreness in arm.  By morning of 10/29/05 - she noted redness from injection site (right deltoid) up her shoulder and down to her wrist. Self-treated with Benadryl and warm compresses and ibuprofen.  By morning of 11/1/01, all redness and soreness had resolved.									Y	10/28/2005	10/28/2005	0		UNK	UNK		None				1						1	Injection site erythema; Pain	FLU3~SANOFI PASTEUR~U1815AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246636	11/02/2005	KS	61.0	60		F	11/02/2005	Onset 5x7 erythematous raised urticarial lesion to left deltoid around injection site.  Received FLUARIX Lot AFLU145AA 10-31-05 IM to LD.  Developed swelling at injection site within 24 hours.  No fever, chills, purulent drainage or axillary LAD present.  C/o mild itching.				Y					Y	10/31/2005	11/01/2005	1	none performed	UNK	UNK	Premarin 0.625 QD, Diovan HCT 160/12.5 QD, ranitidine 150 qd, Cloardipot 3.75 mg prn anxiety, fiber, calcium stoool softener	none known	PCN, Sulfa caused hives			1						1	Injection site erythema; Injection site swelling; Injection site urticaria; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA145AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0246637	11/02/2005	IL	43.0	43		M	11/02/2005	Sore throat, headache, sinus drainage, tired, chronic aches, chronic cough. Similar to Flu.  Treatment: OTC Sinus medicine, cough syrup. Doctor prescribed 3 day script of 500MG Zithromax on 10/31/05.									Y	10/25/2005	10/28/2005	3	None	UNK	UNK	Zoloft, Previcid	None	Cerebral Palsy	Same As Above~Influenza (Seasonal) (no brand name)~1~0.00~In Patient		1						1	Cough; Fatigue; Headache; Pharyngolaryngeal pain; Sinus congestion	FLU3~SANOFI PASTEUR~V1830AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246638	11/02/2005	CA	55.0	54		F	11/02/2005	Pt. was hospitalized for cellulitis in arm that both the flu and the PPV vaccinations were administered. Right arm started hurting within a few hours of the injections.  Client woke up next a.m. with chills and had a fever of 103 degrees, headache, nausea and severe pain in right arm.  Client on Vancomycin, Unisyn and Amoxicillin.  Cultures are pending at this time. 1/24/06 Review of 1-page d/c summary confirms diagnosis of cellulitis of R arm with associated fever, and leukocytosis.					Y	4			U	10/30/2005	10/30/2005	0		UNK	UNK	Estrogen & Vitamins	None	None			1						1	Cellulitis; Chills; Headache; Injection site reaction; Leukocytosis; Nausea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1828AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0605R~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0246639	11/02/2005	NY	82.0	81		M	11/02/2005	Became dizzy at approximately 12:00 noon, fell on sidewalk. Weakness in legs.				Y					Y	11/01/2005	11/02/2005	1	on file at hospital.	UNK	UNK						1						1	Dizziness; Fall; Muscular weakness	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0246640	11/02/2005	AK	27.0	27		M	11/02/2005	Pt with disseminated vaccinia lesions in periphery of initial vaccination site. No intervention.									U	10/06/2005	10/15/2005	9		MIL	MIL						1						1	Injection site vesicles	FLU3~SANOFI PASTEUR~U1771AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020072~1~ID~RA~SMALLPOX (DRYVAX)~1	USA		Influenza
0246642	11/02/2005	MA	0.67	0	.7	F	11/02/2005	Vaccine received 10/26/05. Had brief URI with low grade fever 1 week prior with normal exam. 10/27/05 Began with recurrent lip smacking and drowsiness. EEG consistent with focal seizures. Information from 60 day report states: Ongoing seizure disorder controlled with medication. Felt due to cerebral malformation and not due to influenza vaccine. As per follow up report, reproter wrote to correct pts last name and provided the following information. MRI revealed developmental abnormality on left temporal cortex in hospital, thus neurological conclusion is that is a congenital condition not vaccine related. Medical records state cough. msv					Y				N	10/26/2005	10/27/2005	1	Medical records states eeg abnormal. msv Medical records state abnormal lab test. msv	PVT	PUB	NONE		Medical records states brain syndrome. msv			1						1	Congenital anomaly; Convulsion; Cough; Electroencephalogram abnormal; Laboratory test abnormal; Neurodevelopmental disorder; Pyrexia; Somnolence; Tardive dyskinesia; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~U1747AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0246645	11/02/2005	SC	9.0	8		M	11/02/2005	Pt was given flu mist yesterday then he broke out in hives that night the hives were not itchy and would move to different parts of body.									N	11/01/2005	11/01/2005	0		PUB	PUB	Zyrtec, Zatatore, eye drops	swollen eyes, allergic conjunctivitis, allergic rhinitis				1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~UNK~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0246650	11/02/2005	IA	50.0	49		F	11/02/2005	Swollen glands in neck, rash all over body, fever, tongue burned, swollen. Went to private doctor 10/9/05 put on steroid, received injection - pt not subjection has had flu shots in the past w/out reaction.				Y						10/28/2005	10/28/2005	0		PUB	PVT	Enalapril;Synthroid;Clarinex;Lipitor;Furosemide;Aciphex;Sulfasalazine Over the counter eye caps & multivitamins	NONE	Demerol & Neomycin Sulfate			1						1	Lymphadenopathy; Pyrexia; Rash; Tongue disorder; Tongue oedema	FLU3~SANOFI PASTEUR~U1775AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246651	11/02/2005	IA	42.0	41		F	11/01/2005	took immunization about 11:30am 10/28/2005 when took nap that afternoon had bizarre dreams, that evening began to swell get red and hot, through next day continued swelling maximum size tennis ball was hot, hard, tender, did not ever take temp, talked with someone on 10/31/2005 3 days after injection. Site has went from size to tennis ball to current size of egg, cont red, hard tender and itching, is still having crazy dreams. 01/01/2005 talked to someone again, no itching today, did not have strange dreams 2st time last night and swelling almost gone, historically had a reaction like this 1x with TD immunization, but took Hep A x2 with no problems at all.									Y	10/28/2005	10/28/2005	0		PUB	UNK	Atenolol, Nortriptyline	NONE	Fibromyalgia			1						1	Abnormal dreams; Feeling hot; Injection site hypersensitivity; Injection site induration; Injection site oedema; Pruritus; Tenderness	FLU3~SANOFI PASTEUR~U1904AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246752	11/02/2005	WA	42.0	42		F	11/01/2005	* see 2nd page written by the patient discussing this in detail. The reaction involved the pneuno vaccine (left arm) fever 102.6, arm swollen, red, cellulitis, AB tx				Y					Y	10/17/2005	10/18/2005	1		OTH	UNK						1						1	Cellulitis; Erythema; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U1805AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0055R~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246646	11/03/2005	IL	82.0	81		F	10/31/2005	Slight swelling at inject site 10/24/2005 day of inject. 10/25 soreness 4-5 cm down from inj site physician noted redness and slight warmth antibiotic prescribed Doxycycline 100 BID 7d, At MDs office.									Y	10/24/2005	10/25/2005	1		OTH	OTH		NONE				1						1	Feeling hot; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U18066AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246647	11/03/2005	WV	54.0	54		F	11/02/2005	Swelling, redness, could not use arm for 2 days, missed 1 day work, fever, chills for 24 hours, Treatment ice packs.									Y	10/31/2005	10/31/2005	0		PUB	PUB	NONE	NONE	Asthma			1						1	Chills; Erythema; Hypokinesia; Oedema; Pyrexia	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~UNK~UNK~~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0246648	11/03/2005	OH	66.0	65		F	11/01/2005	Pt called store 11/01/2005 with complaints of very sore arm.				Y					U	10/17/2005				OTH	OTH						1						1	Pain	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246649	11/03/2005	OH	68.0	68		M	11/02/2005	Sore arm									U	10/04/2005				OTH	OTH						1						1	Pain	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246658	11/03/2005	IA	0.76	0	.8	M	10/27/2005	Within 24 hours after administration pt had developed fever up to 103, seizures secondary to fever. Pt was taken to ER per ambulance and was admitted for observation. Pt was diagnosed with an urinary tract infection.				Y	Y	2			Y	10/24/2005	10/25/2005	1	Information received from medical records states anemia, leukocytosis.msv	PVT	PVT	NONE		Medical records states congenital anomaly. msv			1						1	Anaemia; Convulsion; Leukocytosis; Pyrexia; Urinary tract infection	FLU3~SANOFI PASTEUR~U1743NA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0246659	11/03/2005	NE	42.0	42		F	10/28/2005	Pain in left scapular region progressively warm and debilitating, radiating to base of neck to left shoulder and arm. Med hx of asthma added from Med Record rec'd 11/10/2005. Additional medication added--Advair/sr Additional term added form med record rec'd 11/30/2005: Neuropathy/sr Discharge summary states asthma, rhinitis. msv				Y	Y				Y	10/14/2005	10/21/2005	7		PVT	PVT			Discharge summary states thrombosis. msv			1						1	Asthma; Feeling hot; Neuropathy; Pain; Rhinitis	FLU3~SANOFI PASTEUR~U1832BA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0246661	11/03/2005	MD	36.0	36		F	11/03/2005	Patient describes after receiving Adacel and day later became very sick, projectile vomiting, temperature. Went to ER 2 days after and was admitted to ICU. Discharged 3 days later. Diagnosis is also Pneumonia. Information from 60 day follow-up report states: Vaccinee back to work no residual problems.					Y	3			Y	10/27/2005	10/28/2005	1		PUB	PVT	UNK		Diabetes Mellitus			1						1	Malaise; Pneumonia; Pyrexia; Vomiting projectile	FLU3~SANOFI PASTEUR~U1864AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0246662	11/03/2005	OR	41.0	41		F	11/01/2005	Within 24 hours after getting flu mist I developed lots of nasal congestion and runny nose that developed to sinus pressure persisting 2-3 weeks.									Y	10/07/2005	10/08/2005	1	NONE	PVT	OTH		NONE	NONE			1						1	Nasal congestion; Rhinorrhoea; Sinus headache	FLUN3~MEDIMMUNE VACCINES, INC.~500426P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0246663	11/03/2005	OR	49.0	48		M	11/01/2005	Within 24 hours after receiving flu mist became very nasal congested, ears burning, sinus congestion.				Y					N	10/15/2005	10/16/2005	1	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Ear disorder; Nasal congestion; Sinus congestion	FLUN3~MEDIMMUNE VACCINES, INC.~500426P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0246664	11/03/2005	OR	6.0	5		F	10/17/2005	Within 20 mins after receiving flu mist had a severe nose bleed in automobile on way to walmart.				Y					Y	10/17/2005	10/17/2005	0	NONE	PVT	UNK		NONE	NONE			1						1	Epistaxis	FLUN3~MEDIMMUNE VACCINES, INC.~500391P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0246665	11/03/2005	OK	68.0	67		F	11/02/2005	Friday 10/28/2005 hurt but no swelling, Sat 10/29/2005 swelling, aching, redness appeared in blotches, course of day redness increased to elbow front and back. Sunday 10/30/2005 swelling, Monday 10/31/2005 swelling subsided continues to have some aching inside with some swelling to right arm. DR saw patient and instructed pt to use ice pack to area. Pt denies SOB.										10/28/2005	10/28/2005	0		PUB	OTH						1						1	Erythema; Oedema; Pain; Rash macular	FLU3~SANOFI PASTEUR~U1929AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0741R~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246666	11/03/2005	HI	8.0	7		M	10/31/2005	Received flu vaccine 10/21/2005 left arm. irritation, pain, itching to area x 2 days. Local reaction to flu vaccine, now with possible cellulitis.				Y						10/21/2005	10/24/2005	3		UNK	UNK						1						1	Cellulitis; Injection site pain; Injection site reaction; Pruritus; Skin irritation	FLU3~EVANS VACCINES~61123~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0246667	11/03/2005	CO	49.0	49		F	10/28/2005	Given flu vaccine short while after began to itch all over and hives developed.				Y						10/28/2005	10/28/2005	0	Seen in Hospital	UNK	UNK			NONE			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1833BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246668	11/03/2005		43.0			F	10/24/2005	Breathing difficulties with flu vaccine											07/08/2005			UNK	UNK			Pt has hx of multiple allergies including ragweed, cats, grass, dogs.			1						1	Dyspnoea	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246669	11/03/2005	GA	0.51	0	.5	F	11/03/2005	Urticaria, Benadryl				Y					Y	11/01/2005	11/01/2005	0	NONE	PVT	PVT	NONE	NONE	Atopic dermatitis			1						1	Urticaria	DTAP~SANOFI PASTEUR~U1350BA~3~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1903AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0026P~1~IM~LL~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~A98341C~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0246670	11/03/2005	ID	1.02	1	.0	F	11/02/2005	Severe erythema multiforme minor beginning 11/10/2005									N	10/21/2005	11/01/2005	11		PVT	PUB	Amox	URI, otitis media				1						1	Erythema multiforme	FLU3~SANOFI PASTEUR~U1787EA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0486R~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A98339C~5~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0428R~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0246671	11/03/2005	NY	41.0	41		M	10/31/2005	Problem was with shoulder area (left arm) went to primary physician diagnosed with arthritis in rotate cup.				Y					Y	10/03/2005	10/04/2005	1	Arthritis L shoulder	PVT	PVT						1						1	Arthritis; Shoulder pain	FLU3~SANOFI PASTEUR~U1833BA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246672	11/03/2005	CO	62.0	62		F	11/02/2005	Pneumonia shot given in right arm on 10/28/2005. By evening I was unable to lift my arm more than 6 from body. Large red line under swelling, Welt increased in size on Saturday but mobility improved. Welt still red and larger but good mobility by Sunday. Monday less swelling and redness and soreness. Tuesday just slight discoloration, strength also affected.									Y	10/28/2005	10/28/2005	0		UNK	UNK			Allergies Penicillin, sulfa, aspirin			1						1	Asthenia; Hypokinesia; Injection site erythema; Oedema; Pain; Skin discolouration; Urticaria	FLU3~SANOFI PASTEUR~U1864AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0790P~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246673	11/03/2005	NJ	76.0	75		M	10/19/2005	Initial pain when flu vaccine was given, chills that night. Swelling to elbow of left arm next day and continued down arm to fingers by third day. Private MD was called suggested cold-hot applications. Swelling started to subside next day.									Y	10/12/2005	10/13/2005	1	NONE	PUB	PUB			NONE			1						1	Chills; Oedema; Pain	FLU3~SANOFI PASTEUR~U1836AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0513P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246674	11/03/2005	VA	75.0	75		F	10/31/2005	By Friday afternoon Pt arm was swollen with fluid Saturday it was swollen to wrist. Red somewhat and tender called hospital referred to PMP. Spoke with Dr who suggested Benadryl and Tylenol and elevation of arm. Pt cannot take Benadryl but took Tylenol 2 tab Q 4 hours. Is too busy to elevate arm. By Monday arm much better, will go to PMD on Tuesday if not 100% improved.										10/28/2005	10/28/2005	0		PUB	PVT	Prevacid, Plavix, Lotrel, Coreg, Lipitor	NONE	Hx stroke, HX colon CA, carotid artery graft.			1						1	Erythema; Fluid retention; Oedema; Tenderness	FLU3~SANOFI PASTEUR~U1836AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0692P~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246675	11/03/2005	GA	74.0	73		F	10/12/2005	Pneumonia vaccine given in right deltoid at app 11:28am. Noticed arm was sore and swollen at app 5pm. put a cold compress on arm and took a Darvocet. unable to sleep for pain. Has not taken anything or used cold compress today 10/12/2005 suggested she take Tylenol and put cold compress on arm. Deltoid area is swollen and warm to touch no other complaints									Y	10/11/2005	10/11/2005	0		PUB	PUB	Benacor, Zoloft	NONE	Sinus problems, hypertension, IBS, depression		GA05037	1						1	Insomnia; Oedema; Pain	FLU3~SANOFI PASTEUR~U1747AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246676	11/03/2005	GA	79.0	78		F	10/12/2005	PMA administered 10-6-05 at apx 11:00. By evening pt exp soreness at injection site. Took 1 extra strength Tylenol. Next am arm was red, hard and very tender to touch, feverish from injection site to mid biceps/triceps. Place cold compress on area, took Tylenol. Area cont to be sore, feverish and red for 3 days. By 4th day was beginning to feel better, but still some discomfort (primarily soreness)									Y	10/06/2005	10/06/2005	0		PUB	PUB		Sneezing	Hypertension 3 Bypasses		GA05036	1						1	Erythema; Injection site induration; Injection site pain; Myalgia; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~U1747AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~0456P~2~~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0246677	11/03/2005	GA	68.0	67		F	10/06/2005	Patient reports eating supper 10/5/05 and feeling funny stood up-passed out/vomited up to. Went to ER vitals within normal limits. Saw PCP 10-6-05 has large area on right upper arm from elbow to shoulder. Red hot-edematous-PCP instr. pt to take Benadryl and prescribed antibiotic.				Y					Y	10/05/2005	10/05/2005	0	NONE	PUB	PUB	Cholesterol Meds;Hypertension Med; Hypoglycemic Meds	NONE	Lung Cancer, NIDDM, HTN; High Cholesterol		GA05035	1						1	Erythema; Feeling hot; Injection site hypersensitivity; Injection site oedema; Loss of consciousness; Malaise; Vomiting	FLU3~SANOFI PASTEUR~U1747AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246678	11/03/2005	AL	82.0	82		M	10/01/2005	Had shot at 10:30 am; developed a cough, sob; wheezing and hoarseness. He took Claritin 10mg and Robitussin cough syrup. Was better by 5:00 pm. Reaction started at 5:00 pm - 8:00 pm									Y	10/25/2005	10/25/2005	0	NONE	PUB	PUB	Adenotol 50 mg Timoptic	NONE	Hypertension, Macular degeneration, Cancer of prostate		AL0512	1						1	Cough; Dysphonia; Dyspnoea; Wheezing	FLU3~SANOFI PASTEUR~U1811AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246679	11/03/2005	OH	0.76	0	.8	F	10/28/2005	On the afternoon of 10/24/05 got the following immunizations- DTAP, HIB, Prevnar, Fluzone. Approximately 11 hrs later developed a fever, approx 1 hr later temp checked = 105 registered.  Eyes rolled back in head but no shaking episode. Pt had Tylenol approx 2 hrs prior to temp being 105. was seen in ER-T=102 registered.				Y						10/24/2005	10/25/2005	1	COBC 9700 H/H - 11.8/34.5 PL = 252,000 499P:35.7L;13.2M;5.UE;1.2 BA 30 greater that 2B;42P;48l;Zatyps 4M;4E No. 132; K=4.3;CR=104;CO2=18;GLU=120;BUN=8;Cruat=0.3;Ca=9.8;CTOP brain =NL	PVT	PVT	No med at time of shots-later took Tylenol & Motrin	NONE- well that day	NKA;S/P URI & Gastro (remote) 10-5-05 URI & cough			1						1	Eye movement disorder; Pyrexia	DTAP~SANOFI PASTEUR~U1397BA~3~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1743HA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE641AA~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A74406B~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0246680	11/03/2005	IA	46.0	45		F	10/31/2005	Given vaccine at 6:25 am, started with diarrhea at 11:00 am 10/27/05									Y	10/27/2005	10/27/2005	0		MIL	PVT		NONE				1						1	Diarrhoea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA150AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246681	11/03/2005	MO	52.0	51		M	11/01/2005	Eyes started feeling gravely about 10 when he was going to bed. Eyes were almost swollen shut, had swelling under tongue (not throat) Wife called nurse line. He had taken a dose of Dayquil, she had visit with pharmacist and said to give him Benadryl and to go to ER if not better in 1 hr. He was better and did not have to go to ER. Never had difficulty swallowing. C/O bad taste in mouth, eyes puffy until Sun.									Y	10/28/2005	10/28/2005	0		PUB	UNK		NONE	NONE			1						1	Eye disorder; Eye swelling; Tongue disorder	FLU3~SANOFI PASTEUR~U1849AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246682	11/03/2005	CA	0.51	0	.5	M	10/28/2005	Flu shot given to pt at 4:00 pm (10/28/05 - 0.25 ml IM right leg after 20 min at 4:20 pm - redness and warmth only on right leg. Notified Dr 2 hrs - cold compress & Tylenol dosage given. If swelling on mouth & eyes cold compress or call for appt. Difficulty breathing - 911 MM  revivification - understanding murmur develop for 2 hours.										10/28/2005	10/28/2005	0		OTH	UNK		NONE	NONE			1						1	Arrhythmia; Dyspnoea; Erythema; Feeling hot	FLU3~SANOFI PASTEUR~U1848AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246683	11/03/2005	CA	0.78	0	.8	F	10/25/2005	Flu shot given to pt at 10:25 am (10/25/05) = 0.25 ml IM left leg after 15 min at 10:40 am had allergic reaction, redness on left leg and lower back. Notified doctor and check pt.									Y	10/25/2005	10/25/2005	0	NONE	OTH	UNK		NONE	NONE			1						1	Erythema; Hypersensitivity	FLU3~SANOFI PASTEUR~U1861AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246684	11/03/2005	MD	35.0	35		F	11/01/2005	C/O onset of rhinorrhea, nasal congestion, fatigue, sinus pain, viselike headache, temp 102 degrees F times 9 days, chills, nausea, anorexia, myalgia,  arthralgias onset of symptoms 48 hours after flu mist.				Y					N	10/21/2005	10/23/2005	2	CBC at diff & PLT - WNL	MIL	MIL	Synthroid OCPS		Hypothyroidism			1						1	Anorexia; Arthralgia; Chills; Fatigue; Headache; Myalgia; Nasal congestion; Nausea; Pyrexia; Rhinorrhoea; Sinusitis	FLUN3~MEDIMMUNE VACCINES, INC.~500390P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0246685	11/03/2005	NY	43.0	42		F	10/28/2005	Local reaction at site red, warm & itchy over 7 1/2 cm area									Y	10/27/2005	10/28/2005	1		PUB	PVT	Zetia Effexor Prevacid Yasmin	NONE	Asthma			1						1	Application site reaction; Erythema; Feeling hot; Pruritus	FLU3~SANOFI PASTEUR~U1827AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246686	11/03/2005	GA	3.0	3		M	10/28/2005	Large red lump at shot site.									Y	10/25/2005	10/27/2005	2	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Erythema; Injection site mass	FLU3~SANOFI PASTEUR~U17430AA~3~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246687	11/03/2005	NY	58.0	58		F	10/28/2005	Local reaction@ injection site. Red, warm and itchy 7cm area.									Y	10/27/2005	10/28/2005	1		PUB	PUB	Bextra, Meclizine, Toprol XL, HCTZ, Calcium, ASA 81, MVI			local reaction @ injection site, red, warm and itchy 7cm area~Influenza (Seasonal) (no brand name)~~57.00~In Patient		1						1	Cellulitis; Feeling hot; Injection site hypersensitivity; Injection site reaction; Pruritus	FLU3~SANOFI PASTEUR~U1827AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246688	11/03/2005	OR	60.0	59		F	10/28/2005	32 hrs after Flu vaccination a large deep red area about 2 1/2 inches below the injection spot. Spot was slightly swollen and warm to the touch. 6 hours spot started to bruise.									Y	10/25/2005	10/26/2005	1		PUB	PUB	Cholesterol med., Coumadin, Nortriptyline	NO				1						1	Contusion; Erythema; Feeling hot; Swelling	FLU3~SANOFI PASTEUR~U1818AB~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246689	11/03/2005	NY	46.0	46		F	10/28/2005	Local reaction at site of injection. Red, warm, itchy measured 11cm across.									Y	10/27/2005	10/28/2005	1		PVT	UNK						1						1	Feeling hot; Injection site erythema; Injection site hypersensitivity; Injection site reaction; Pruritus	FLU3~SANOFI PASTEUR~U1827AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246690	11/03/2005	IL	52.0	51		M	10/21/2005	Cannot move arm without pain. Taking Aleve for the pain. Extreme pain in biceps musclic ? Pain radiates up to neck region. Arm movement makes pain worse. Pain is severe enough so that he must sleep in chair warm moist heat does not relieve the pain.				Y						10/12/2005	10/13/2005	1		UNK	UNK		NONE	NONE			1						1	Hypokinesia; Myalgia; Neck pain; Pain	FLU3~SANOFI PASTEUR~U1806AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246713	11/03/2005	MO	32.0	32		M	11/02/2005	This case was reported by a nurse and described the occurrence of Bell's palsy symptoms in a 32-year-old male subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. The subject's medical history included carpal tunnel syndrome, obesity and resolved hypothyroidism. The subject does not consume alcoholic beverages or use tobacco. There were no concurrent medications. On Oct 31 2005 the subject received the 1st dose of Fluarix (lot AFLUA151AA). The nurse reported that, This office does not have a record of flu vaccines from the past. On Nov 1 2005, 1 day after vaccination with Fluarix, the subject experienced Bell's palsy symptoms characterized by inability to blink the right eye and decreased sensation on the right side of the face and was seen at a physician's office. The events were considered to be jeopardize the subject or require intervention. The Bell's palsy symptoms were ongoing at the time of initial reporting. Nov 2 2005. The nurse considered the Bell's palsy symptoms to probably be related to vaccination with Fluarix. Comment Bell's palsy symptoms was assessed as medically serious by manufacturer (OMIC). The Bell's palsy symptoms were ongoing at the time of follow-up reporting, 01 November 2005.				Y					N	10/31/2005	11/01/2005	1	UNK	PVT	PVT	NONE; No concurrent medication	The subject's concurrent conditions were not reported.	Carpal Tunnel Syndrome; Hypothyroidism; Obese		A0580533A	1						1	Eyelid disorder; Facial palsy; Hypoaesthesia facial	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA151AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0246719	11/03/2005	NY	0.88	0	.9	F	11/03/2005	Severe irritability, breathing with audible stridor, croup like symptoms, positive lethargy. IN the ER, received Decadron injection, Epinephrine, Albuterol treatment and then transferred to ICU. No new terms in Discharge Summary rec'd 12/08/2005/sr			Y	Y	Y	2			Y	11/01/2005	11/01/2005	0		PVT	PVT						1						1	Croup infectious; Hyperventilation; Irritability; Lethargy; Stridor	FLU3~SANOFI PASTEUR~U1765DA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0246720	11/03/2005	AK	4.0	4		M	11/03/2005	Low grade fever and rhinorrhea for 2 days after administration.  Developed reddish brown area around site of injection, which persisted 8 days post injection.									Y	10/26/2005	10/29/2005	3	NONE	PVT	PVT						1						1	Injection site erythema; Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1849AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246722	11/03/2005	FL	67.0	67		F	11/03/2005	CHILLS WITH VIOLENT SHAKING BEGINNING AT ABOUT 8:15 PM; WENT TO THE ER AT THE ADVISE OF FRIENDS VISITING ARRIVING AT 10 PM; 100 DEGREE TEMPERATURE.  ER GAVE 2 TYLENOL AND COVERED WITH WARM BLANKETS. PATIENT LEFT BY MIDNIGHT.  HAD SOME MUSCLE ACHES BUT FELT ALRIGHT BY MORNING.				Y					Y	11/01/2005	11/01/2005	0	N/A	UNK	UNK			MALROTATION OF THE BOWEL, ITP.  ALLERGIC TO EES, CORTIZONE, CODINE, SULFA, IODINE, PCN, DARVON			1						1	Chills; Myalgia; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U1904AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246726	11/03/2005	KS	63.0	62		F	11/03/2005	Client reported that she was sweating through the night, has temp. of 95.8, has chills and feels achy. Came to work, but went home ill about 10:15 AM.										11/02/2005	11/03/2005	1		UNK	UNK						1						1	Body temperature decreased; Chills; Night sweats; Pain	FLU3~EVANS VACCINES~61503~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0246727	11/03/2005	TN	63.0	63		F	11/03/2005	Patient had temperature of 102 degrees.									Y	11/02/2005	11/03/2005	1	N/A	UNK	UNK	Osteo Bi-Flex P.O. Daily	No	Morphine Tomatoes			1						1	Pyrexia	FLU3~SANOFI PASTEUR~U1866AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246729	11/03/2005	PA	70.0	70		F	11/03/2005	Six hours after shot on 10/7/05 had severe chills, shakes, felt miserable, high heart rate; went to ER and held for hours; symptoms gradually improved; WBC 10.5 7 bands, 85segs,; patient felt better by next day.				Y					Y	10/07/2005	10/07/2005	0	CBC-- WBC 10.5, 7bands 85 segs; lytes normal BUN and creat normal; TSH normal, EKG sinus tachycardia; normal D-dimer	UNK	UNK	Lopid, Colestid, vitamin, ASA	none	Allergic to codeine, sulfa, avelox, cipro, some dyes			1						1	Chills; Heart rate increased; Malaise; Sinus tachycardia; Tremor	FLU3~SANOFI PASTEUR~E1773AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246731	11/03/2005	NY	24.0	24		M	11/03/2005	Palpitations, near syncope Vertigo/dizziness nausea, no vomiting Evaluated in emergency department.  EKG, CT negative. Given IV Fluids, Antivert, phenergan, improved, sent home				Y					Y	11/02/2005	11/02/2005	0	CT scan brain normal	UNK	UNK	Lipitor, ASA	none	hyperlipedemia vaccinated in 2005 for military			1						1	Dizziness; Nausea; Palpitations; Syncope; Vertigo	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA138BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0246733	11/03/2005	WA	63.0	63		F	11/03/2005	Approx. 33 hours after receiving the Fluzone vaccination, the pt. reports a large, solid, raised welt extending from injection site to elbow on L arm.  She says it itched like a hive. Later, round, smaller welts appeared on her left shoulder, back, left and right legs and on her buttocks.  These welts also itched. She used Aveeno to relieve the itching, which it did. She also took a dose of 50mg Benadryl, which seemed to help, also. She does not complain of any other symptoms.  The welts have cleared as of 11/3/05.									Y	10/31/2005	11/01/2005	1	none	UNK	UNK	Vesicare (on since 5/05)	none	none			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1805AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246734	11/03/2005	MD	50.0	49		F	11/03/2005	Patient received flu shot around 8:30 this morning.  This afternoon around 4:00pm after awakening from a nap she noticed a rash on face and stomach.  Patient has never had the flu shot before.  Advised to take benadryl and if it does not get better to visit the ED ASAP.  Advised of symptoms of servere allergic reaction.									U	11/03/2005	11/03/2005	0	None at time of report	UNK	UNK	None Known	No	Asthma, PCN Allergy, Roscea			1						1	Rash	FLU3~SANOFI PASTEUR~U1904AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246736	11/03/2005	MN	56.0	56		M	11/03/2005	Beginning about 36 hours after vaccination, began experiencing chills, headache, body aches, shivering. Fever developed about 48 hours after vaccination. Fever peaked at 102.2 deg about 54 hours after vaccination. Fever accompanied with strong chills, headache, body aches, strong shivering. On recommendation of personal doctor, treated with alternate Tylenol and Advil.									Y	11/01/2005	11/02/2005	1	None.	UNK	UNK	Maxzide 37.5-25 once daily.	None.	None.			1						1	Chills; Headache; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246737	11/03/2005	CA	11.0	11		M	11/03/2005	tonic- clonic seizure 54 hours post vaccination.				Y					U	10/14/2005	10/16/2005	2	sma 12, ct, mri all wnl	UNK	UNK	none	none	allergy-sulfa			1						1	Convulsion	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0246740	11/03/2005	OH	53.0	53		F	11/03/2005	HIVES GENERALIZED.				Y					Y	10/25/2005	10/26/2005	1		UNK	UNK			PENICILLIN ALLERGY			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246741	11/03/2005	TX	49.0	49		M	11/03/2005	Patient received Fluzone vaccination of October 29th (Saturday).  Started noticing joint pain (like arthritis per patient) on Sunday.  The pain is all over the body and patient complained that he can't move.  He called in the symptoms on Thursday (November 3rd).  Patient called from work and had not contacted his doctor. He wanted to know if the symptoms could be due to the flu shot or if it was arthritis or something else.  I encouraged the patient to contact his physician first thing in the morning.									U	10/29/2005	10/30/2005	1	n/a	UNK	UNK	Norvasc, Lipitor, Omeprazole	none	High cholesterol, high blood pressure			1						1	Arthralgia; Pain	FLU3~SANOFI PASTEUR~u1903aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246742	11/03/2005	CO	32.0	31		F	11/03/2005	Severe headache and bodyache, fever with chills and sweating (not sure how high fever was), dizziness, weakness, hoarseness, slight sore throat, dry mouth. Moderate to severe symptoms lasted 5-6 hours. Mild symptoms lasted 24+ hours. 1000 mg acetaminophen helped symptoms. I did not have any rash or swelling at injection site, just minor tenderness. I had a flu shot 2 years ago with no adverse reaction.									Y	11/02/2005	11/02/2005	0		UNK	UNK	oral contraceptives	none	none			1						1	Asthenia; Chills; Dizziness; Dry mouth; Dysphonia; Headache; Pain; Pharyngolaryngeal pain; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246743	11/03/2005	FL	41.0	41		F	11/03/2005	Left arm was swollen 2x normal size, redness and heat from site of shot to elbow.  Became nauseous and dizzy when rising at one point (6-7 hours post shot).  Took ibuprofen which reduced swelling slightly.  Stomach slightly nauseous throughout next day.  Arm is showing steady improvement but still not back to normal after 30 hours post shot.									U	11/02/2005	11/02/2005	0		UNK	UNK	allegra D	none	environmental allergies, asthma			1						1	Dizziness postural; Injection site erythema; Injection site swelling; Injection site warmth; Nausea	FLU3~SANOFI PASTEUR~U1792AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0791P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246750	11/03/2005	NC	2.0	2	.2	M	11/03/2005	1 1/2 (one and one half inches) of redness to upper left deltoid 15 to 20 minutes after injection of vaccine . Per doctor Dytan D 1tsp given at 8:45 am. (11/3/05)				Y					Y	11/03/2005	11/03/2005	0		PVT	PUB	Clarinex, Singulair	NONE	Allergic Rhinitis, Asthma			1						1	Erythema	FLU3~SANOFI PASTEUR~U1831AB~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246751	11/03/2005	VA	57.0	56		F	11/03/2005	Itching all over, wheezing, dizziness, hoarse, pale, weak, irregular heart rate increased, metallic taste in mouth. Driven to PCP's office by a relative pt received IM Benadryl & Steroids. Given RX for PO Benadryl, Solu-Medrol and Zantac. Has completed meds. Irregular HR & metallic taste persisting. Plans to f/u with cardiologist.				Y					U	10/28/2005	10/28/2005	0		OTH	OTH	Evista, Advair, Effexor, Synthroid, diuretic, potassium, Trazadone, Soma, Klonopin, Avinza	NONE	Asthma, CHF, Osteo & rheumatoid arthritis, Hashimoto's thyroid, fibromyalgia, osteopenia, allergies to PCN, Keflex, codeine, ASA, reglan,gardenias,dust, mold, and grass.			1						1	Arrhythmia; Asthenia; Dizziness; Dysgeusia; Dysphonia; Pallor; Pruritus; Wheezing	FLUX~UNKNOWN MANUFACTURER~61319~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0246744	11/04/2005	WA	47.0	46		F	11/04/2005	Within half an hour of receiving the flu shot, I experienced pneumonia like symptoms with restricted breathing, my throat swelled and ached, my eyes turned bloodshot, my mouth began to burn, and my tissues began to swell.  I suspect I was allergic to the shot, perhaps there was thimerosal in it.  12 hours later, the pneumonia and restricted breathing were gone, but I experienced painful bloodshot eyes, swelling of hands and feet, gastric distress, and mouth burn and intense thirst.									Y	11/03/2005	11/03/2005	0		UNK	UNK	none	none	none			1						1	Dyspnoea; Eye pain; Fluid retention; Ocular hyperaemia; Oedema peripheral; Pharyngeal oedema; Pharyngolaryngeal pain; Pneumonia; Thirst	FLU3~PFIZER\WYETH~~1~ID~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0246746	11/04/2005	CA	78.0	77		F	11/03/2005	Client had flu vaccine at 9:35am about 10 mins later had tightness in chest, dizziness, pulse below 50. paramedics were called, by the time they arrived client felt better. Paramedic said B/P 134/80 and pulse 76 client taken to ER by ambulance. Flu vaccine was given in left deltoid no sign of reaction from the shot. No redness, swelling, rash. Client was admitted to Hospital-ER said clients condition was not related to flu shot.				Y						11/03/2005	11/03/2005	0		PUB	UNK		NONE	UNK			1						1	Chest discomfort; Dizziness; Heart rate decreased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61123~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0246747	11/04/2005	KS	75.0	74		F	10/19/2005	Left upper arm around and below injection site very warm, swollen around top 1/2 of arm, and red.									U	10/18/2005	10/19/2005	1		MIL	PVT		NONE	NONE			1						1	Feeling hot; Injection site hypersensitivity; Injection site oedema	FLU3~SANOFI PASTEUR~U1811AA~3~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0531P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246748	11/04/2005	IA	10.0	9		M	11/03/2005	pt was given adult influx split Fluarix instead of Fluzone, no symptoms noted at this time.									U	11/02/2005				PVT	OTH		NONE	NONE			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALJUA123AC~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246749	11/04/2005	IA	5.0	4		M	11/03/2005	Pt was given adult influenza split Fluarix instead of Fluzone. No symptoms noted at this time.									U	11/02/2005				PVT	OTH		NONE	Allergic Augmentin			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA123AC~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246756	11/04/2005		25.0			M	11/04/2005	Patient developed Herpes Zoster on his face.  It was mild and treated appropriately.  It occurred two days after the Influenza vaccine was administered.									Y	10/26/2005	10/28/2005	2	Herpes Zoster	MIL	MIL	None	None	None			1						1	Herpes zoster	FLU3~SANOFI PASTEUR~U1771AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246757	11/04/2005	OH	34.0	34		F	11/04/2005	High fever of 101+F (normal body temperature is 96F) Joint aches especially in arms severe back ache lethargy loss of strength in arms, hands numbness in wrists headache									U	11/03/2005	11/03/2005	0		UNK	UNK		None	aspirin, weeds, dust, dog/cat/feather, shellfish			1						1	Arthralgia; Back pain; Headache; Hypoaesthesia; Lethargy; Muscular weakness; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246759	11/04/2005	NJ	27.0	27		F	11/04/2005	On 11/03/05 I received the Inactivated Influenza Vaccine at approx. 1:40pm.  I went to sleep around 8:00pm that evening.  Around 10:00pm I woke up freezing, my feet were so cold and hurt that I wanted to cut them off so I bundled up and stayed in bed.  I also took my temperature it was 100.6 so I took 2 Tylenol Sinus.  Around 11:00pm my body was boiling so I took my temperature again and it was 102.5.  I changed into something cooler and put a cold, damp wash cloth on my forehead.  I fell asleep and woke up to my alarm at 6:00am on 11/04/05, feeling better and just a little weak.									Y	11/03/2005	11/03/2005	0		UNK	UNK	N/A	None.	None.			1						1	Asthenia; Pain; Peripheral coldness; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246760	11/04/2005	SC	18.0	17		F	11/04/2005	Reported reaction to Health Department on 10/27/05.  Upper right arm (site of PPV23) swollen and warm to touch - 2 elongated areas of redness - advised to take Tylenol and apply cool compresses.  11/02/05:  Patient was called by health department for follow-up at which time patient reported arm much improved.									Y	10/25/2005	10/26/2005	1		UNK	UNK	Cellcept; Zantac; Plaquenil; Keflex	Throat infection	Lupus		SC0523	1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1804AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0887P~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246761	11/04/2005	IL	40.0	39		F	11/04/2005	Approx. 3 hours after the shot, I began feeling a squeezing sensation in my throat, my chest burned and I kept coughing a lot.  I thought I had a sudden onset of a cold, but with no other symptoms.  Then I started getting hoarse, and developed hives on the inside of my mouth.  I lost my voice for a short period of time as well, but after receiving benadryl, all the symptoms cleared up.  I am supposed to take it every 6 hours for 3 days, and when the time is getting close for the next dose, I start to wheeze and cough again.				Y					Y	11/03/2005	11/03/2005	0		UNK	UNK		no	allergic to penicillin			1						1	Chest pain; Cough; Dysphonia; Throat tightness; Urticaria; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0246762	11/04/2005	IN	42.0	41		M	11/04/2005	8 hours of the flu shot, felt severe fatigue, chills, fever, headaches, dizziness, fast heart beat.									U	10/03/2005	10/03/2005	0		UNK	UNK		none	none			1						1	Chills; Dizziness; Fatigue; Headache; Heart rate increased; Pyrexia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246764	11/04/2005	NJ	31.0	30		F	11/04/2005	I received the flu vaccine yesterday at 3PM, by 6:30 PM, my throat felt completly shut. I could not swallow and I had a slight wheezing. I drank some juice and some warm tea, but it didn't help. I was so tired, I went to bed. Although I felt hot, I had the chills and my teeth begin to chatter. I woke up a couple of hours  later and my eyes were puffy, swollen and red, with phlegm in the corners.									Y	11/03/2005	11/03/2005	0		UNK	UNK		none	none	Sore throat, fever, chills~Influenza (Seasonal) (Fluzone)~1~0.00~In Patient		1						1	Chills; Dysphagia; Eye discharge; Eye swelling; Fatigue; Ocular hyperaemia; Throat tightness; Wheezing	FLU3~SANOFI PASTEUR~V1910AC~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246765	11/04/2005	NY	63.0	62		F	11/04/2005	Employee thinks may have developed ocular respiratory syndrome. Took vaccine in am on 10/25. Around 2pm throat felt a little tight, nose was slightly runny and felt slight muscle aches. When stood up felt BP drop, but later thought that may have been coincidental since was also having hot flash. States when has hot flashes, BP always goes down. Went home, drank fluids and went to bed, When woke up at 7pm eyes were matted shut. Looked like peanut butter on my eyelashes. No ocular redness. Face may also have been slightly puffy. Also experienced another drop in BP, but again associated with hot flash. When woke up next am felt fine.									Y	10/25/2005	10/25/2005	0	None	UNK	UNK	Toprol Lisinopril Lipitor Evista Norvasc	None	HTN Mild chronic renal insufficiency MVP			1						1	Blood pressure decreased; Face oedema; Hot flush; Myalgia; Respiratory disorder; Rhinorrhoea; Throat tightness	FLU3~SANOFI PASTEUR~U1833BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246766	11/04/2005	NV	41.0	41		F	11/04/2005	Patient had severe myalgias, widespread drug rash on her body, and fever with nausea and vomiting for two days.									Y	10/27/2005	10/27/2005	0		UNK	UNK	None	none	obesity			1						1	Myalgia; Nausea; Pyrexia; Rash; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AfluA120AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246767	11/04/2005	MI	65.0	65		F	11/04/2005	Received flu vaccine (TIV) at noon. At approx 6pm client was ill with aches, fever, chills and diarrhea. Was feeling better by 5am and able to work.									Y	11/03/2005	11/03/2005	0	None	UNK	UNK						1						1	Chills; Diarrhoea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1904AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246768	11/04/2005	OH	58.0	57		M	11/04/2005	10/19/05 numbness left face/cheek; vague complaints re:left leg attributed to exercise.  10/22/05 symptoms worsened, consulted physician, elevated blood pressure.   Bloodwork ran.  10/23/05 awakened with partial paralysis left lower leg and numbness left leg and hip.  Went to emergency room and was admitted to neuro ICU unit.  Diagnosis:  Transverse Myelitis with cervical and thoracic spinal lesions Discharge summary states multiple sclerosis, urinary retension, facial paralysis, confusion, hematuria. msv Medical records include asthenia. msv				Y	Y	6			N	10/12/2005	10/19/2005	7	MRI's, Spinal Taps Discharge summary states thrombocytopenia, hyperglycemia. msv Medical records state Abnormal CSF, abnormal lab tests. msv	UNK	UNK						1						1	Asthenia; Blood pressure increased; CSF test abnormal; Confusional state; Facial palsy; Haematuria; Hyperglycaemia; Hypoaesthesia; Laboratory test abnormal; Multiple sclerosis; Myelitis transverse; Paralysis; Thrombocytopenia; Urinary retention	FLU3~SANOFI PASTEUR~U1775AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0246769	11/04/2005	WI	16.0	16		F	11/04/2005	Mom stated she developed a generalized rash with itching and hives in the evening after receiving the influenza vaccination on 11-1-2005.  Had gone directly to work out after receiving the vaccine and informed mom of rash after returning home.  Mom reported that she called a nurse friend who told her to give Benadryl and to call Public Health the next day to report reaction.  Mom gave Benadryl 50 mg at approximately 7 p.m. and again at 11 p.m. on 11-1-2005. Mom reported that she was completely improved by the next morning.  Public Health informed mom that she might be allergic to one of the components of the vaccine and that she should notify her physician about this reaction and to check with her physician before receiving any future influenza vaccinations. Mom reported that she is not known to be allergic to eggs and eats them all the time.									Y	11/01/2005	11/01/2005	0	none	UNK	UNK	none	none	none			1						1	Rash pruritic; Urticaria	FLU3~SANOFI PASTEUR~U1764AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246770	11/04/2005	IL	3.0	3		M	11/04/2005	Generalized swelling of upper arm and forearm starting day of injection in deltoid.  Tenderness surrounding small bruise at injection site. Swelling continued on day 3 after injection.   No treatment. Using arm in usual fashion.									Y	10/31/2005	10/31/2005	0		UNK	UNK		none	mild intermittent asthma			1						1	Contusion; Swelling; Tenderness	FLU3~SANOFI PASTEUR~u1830aa~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246774	11/04/2005	OK	43.0	42		F	11/04/2005	Shot site was very hot. Arm sore down to elbow and fingers on hand tingling. Chills and sweats occuring intermittently. Body aches and pains. Nausea. Headache. Redness around site.				Y					U	11/04/2005	11/04/2005	0		UNK	UNK		None				1						1	Chills; Headache; Hyperhidrosis; Injection site erythema; Injection site warmth; Nausea; Pain; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0246808	11/04/2005	MI	67.0	66		F	11/04/2005	Right away felt vac.  moving down to arms and vaginal area especially on left side of body. Swollen glands on neck made it  hard to swallow. Took Benadryl states that nurse gave vac higher than should and hit nerve. Felt a bit tired on afternoon so slept more than normal. Had loss of appetite. Next day had racing heart, called clinic. Felt bruised underarm. Doctor order an EKG (130) and set pt to hospital. Took high blood pressure medication, Lanoxin, left on Thursday afternoon. Got exhausted easily during last week of October.				Y						10/12/2005	10/12/2005	0		PVT	PVT			Allergic to Penicillin;Sulfa drugs,Antibiotics, Mercury base products	itchy eyed~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Anorexia; Dysphagia; Fatigue; Lymphadenopathy; Palpitations; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0246809	11/04/2005	VA	75.0	75		F	11/04/2005	Chills, shaking for 15 minutes; called pharmacy who recommended Tylenol. The next 2 days was overly exhausted.				Y					Y	10/21/2005	10/21/2005	0		OTH	PVT	Aspirin;Singulair;Diltia;Ibuterol;Advair;Pravachol;Vitamin Ardeo;Eye drops	NONE	Asthma;Macular degeneration;Heat problems;Allergic to large quantities of aspirin			1						1	Chills; Fatigue; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0246810	11/04/2005	MN	57.0	57		F	11/04/2005	Face and eyes began to swell especially left side of face. Face became red and hot, sit of vac got swollen, sore, red. Called doctor who recommended Benadryl which helped a bit with the swelling. Next day face was swollen again to the point that pinching on upper lid of left eye. Doctor contacted who sent pt to ER. Was in ER all day on Benadryl and steroids. Discharged early evening with the following medications: Prednisone, hydraxon, cimetidine. 11/3/05 woke with swelling again and ER nurse asked her to come back again to ER to be treated spent all day there. Today doing much better, pt notes that can't work for 2 weeks due to the meds she is taking.				Y					U	11/01/2005	11/01/2005	0		OTH	PVT	Lexapro;Topamax	NONE	Migraines and Depression			1						1	Erythema; Eye swelling; Face oedema; Feeling hot; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0246811	11/04/2005	TN	9.0	8		F	11/01/2005	Left arm swollen, red, painful, high fever									Y	10/24/2005	10/25/2005	1		PVT	PVT		NONE	NONE			1						1	Erythema; Pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U1814AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0082R~2~IM~LA~HEP A (VAQTA)~1|PPV~MERCK & CO. INC.~0604R~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246812	11/04/2005	MO	40.0	40		F	11/04/2005	10-07-05 Onset of pain near left eye, vision blurring. 10-10-05 Saw primary care Dr. Dx was ophthalmic migraine. 10-12-05 Saw optometrist Dr was optic Neuritis. 10-20-05 Saw neurologist Dr. was optic neurotics. She wanted to admit me for IV steroid therapy. 10-20-05 Saw retinal specialist for 2nd opinion.				Y						10/05/2005	10/07/2005	2	Visual exams;visual field exams;CT;MRI extensive eye exam with Retinal Specialist	PVT	PVT	NONE	NONE	NONE			1						1	Eye pain; Migraine; Optic neuritis; Vision blurred; Visual field defect; Eye pain; Headache; Migraine; Nausea; Optic neuritis; Vision blurred; Visual field defect	FLU3~SANOFI PASTEUR~U1761AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1761AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0246813	11/04/2005	VA	50.0	50		F	11/03/2005	Quarter size redness; no pruritus;no pain										10/24/2005				PVT	PVT	Trazodone;Ativan	NONE	NONE			1						1	Erythema	FLU3~SANOFI PASTEUR~U1850AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246814	11/04/2005	VA	40.0	39		F		Injection site red, hot to touch, swollen/knot warmth, itchy for 2 days. Arm sore									Y	10/25/2005				PVT	PVT						1						1	Feeling hot; Injection site erythema; Injection site swelling; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U1763AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246815	11/04/2005	VA	66.0	66		M	11/04/2005	2cm Sm. red spot; hot to touch									Y	10/25/2005				PVT	PVT						1						1	Erythema; Feeling hot	FLU3~SANOFI PASTEUR~U1765AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246816	11/04/2005	VA	26.0	25		F	11/05/2005	2 1/2 cm Red spot with warmth feeling									Y	10/25/2005				PVT	PVT						1						1	Erythema; Feeling hot	FLU3~SANOFI PASTEUR~ULN65AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246817	11/04/2005	VA	51.0	50		F	11/05/2005	4.5 cm area of redness;warmth									Y	10/24/2005			More required	PVT	PVT		NONE	NONE			1						1	Erythema; Feeling hot	FLU3~SANOFI PASTEUR~U1763AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246818	11/04/2005	MD	0.63	0	.6	M	11/01/2005	A 7-month-old comes in today because of hives. Apparently this morning he had his influenza vaccine, the first of his series of two. About 2 hours after it, mother noticed a rash. His ears got red and swollen and the rash was red on his abdomen and arms. Seems to be starting to fade somewhat now. He has been acting okay. Never had any trouble breathing. Never developed a cough. Alert, pleasant white male, no distress. TM's pinkish-gray. Oropharynx is clear. Heat and lungs are clear. Abdomen soft. Skin, he does have an erythematous rash, fine macules around his abdomen. But he has several wheels on his arms. His ears are slight red. Urticaria, probably secondary to flu vaccine. Benadryl Elixir 4 ml every 6 hours for the next 2-3 days and until this rash goes away.				Y					U	10/28/2005	10/28/2005	0		PVT	PVT	NONE	NONE	NONE			1						1	Ear disorder; Erythema; Rash; Swelling	FLU3~SANOFI PASTEUR~U1815AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246819	11/04/2005	MA	59.0	58		F	10/28/2005	Pt presented with a large 4.5 X5cm redness on her arm (lateral side) tow days after getting a Flu shot. No fever reported. Seen by nurse practitioner (above) advised  Benadryl, and ice.  Oct.31,05 redness  went away 10/30. Took Benadryl 125mg. one time, ice.				Y					Y	10/27/2005	10/28/2005	1		PUB	PUB	Motrin 800mg	NO	NKA, HTN, Depression GERD, obesity			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U1747AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246820	11/04/2005	CA	32.0	32		F	10/28/2005	Day of shot arm became increasingly swollen, by evening site was red, painful.  Unable to sleep well.  2 days later area still red, approximately 1/2 inch long and 2 inches wide and still tender to touch.									Y	10/26/2005	10/26/2005	0	NONE	PUB	PVT	NONE	NONE	NONE			1						1	Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~U1864AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246821	11/04/2005	GA	61.0	61		F	11/01/2005	30 minutes after flu shot, she began to have itching on hands and soles of feet.  1% hydrocortisone cream applied to palms of hands and soles of feet, cold packs to feet - No shortness of breath - sent to be evaluated by physician.									Y	11/01/2005	11/01/2005	0		OTH	UNK	Prilosec, Ibuprofen	NONE	GERD			1						1	Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA127BB~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246822	11/04/2005	NC	66.0	66		M	10/24/2005	Within hours after receiving vaccines developed fever 102 degrees, redness on arm, realized he had a pneumonia shot last year at private doctor, (forgot when asked at Health Department).  Saw doctor, advised to take Tylenol and cold compress.				Y					Y	10/18/2005	10/18/2005	0	NONE	PUB	PVT	Captopril, Metoprolol, Hydralazine, Vitarin, Aspirin, Calcium, Omega 3, Aphagon P, Predforte, Dostinep, Acyclovir, Folic Acid	NONE	Herpes in eyes, Hypertension			1						1	Erythema; Pyrexia	FLU3~SANOFI PASTEUR~U1904AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246823	11/04/2005	NC	66.0	66		M	10/19/2005	Swollen, red and warm to touch area at injection site, 6 inches long and 2 inches wide (onset approximately 2 hours after injection).									U	10/18/2005	10/18/2005	0	N/A	PUB	PVT	NONE	None reported	None stated			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1904AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0967P~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246824	11/04/2005	NC	79.0	79		M	10/26/2005	Flu shot 10/17/2005, left deltoid - 10/23/2005 had bruising below bicep at elbow and tightness in tricep muscle.  No swelling, tenderness, or pain.									U	10/17/2005	10/23/2005	6	NO	PUB	PVT	Bextra, Tramadol, Aspirin	NO	NO			1						1	Contusion; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U1836AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246825	11/04/2005	NC	69.0	68		F	10/26/2005	Patient reported the morning of 10/18/2005, fatigue, nausea, swelling to left deltoid.  Wednesday night (10/18/2005) diarrhea and tachycardia.  Experienced visual hallucinations related to lack of sleep.  4x4 cm swelling, redness at injection site.				Y					Y	10/17/2005	10/18/2005	1	NO	PUB	PVT	Evista, Eneptrimine, Mostiuou, Aspirin, Dictrapanexl, Novuring	NO	NO			1						1	Diarrhoea; Fatigue; Hallucination, visual; Injection site erythema; Injection site swelling; Nausea; Sleep disorder; Tachycardia	FLU3~SANOFI PASTEUR~U1836AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0967P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~AVENTIS PASTEUR~U1597A~UNK~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0246826	11/04/2005	NC	69.0	69		F	10/14/2005	Redness, swelling and hot to touch at injection site.  10/14/2005 weight 185 1/2 lbs, pulse 69, temperature 98, blood pressure 128/73.									Y	10/11/2005	10/12/2005	1	NONE	PUB	PVT	Metoprolol, Ditropan, Effexor, Requip, Voltaren	NONE	Allergy to Cefzil.			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246827	11/04/2005	NC	73.0	73		M	10/13/2005	Returned to clinic 24 hours after receiving shots, right arm red and swollen from lower deltoid area to elbow, inner, aspect of arm.  Referred to private physician, who advised cold compresses and Benadryl.				Y					Y	10/12/2005	10/13/2005	1	NONE	PUB	PVT		NONE				1						1	Oedema peripheral	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0967P~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1|TD~AVENTIS PASTEUR~U1597CA~UNK~IM~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0246828	11/04/2005	NC	80.0	79		F	10/18/2005	High Fever (101.9), nausea, diarrhea for 3-4 days, tongue coated, pains.  Symptoms started 2 days after flu vaccine administered.									Y	10/10/2005	10/12/2005	2	N/A	PUB	PVT	Not available	None noted	NO			1						1	Diarrhoea; Nausea; Pain; Pyrexia; Tongue discolouration	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246829	11/04/2005	WI	42.0	41		F	10/28/2005	Flu shot given 10/27/2005.  Patient developed red raised itchy rash in the morning 10/28/2005.  Patient also on IV Levaquin and Clindamycin 10/23-10/25.  Started on antibiotics on 10/26/2005.				Y					U	10/27/2005	10/28/2005	1		PVT	OTH	Levaquin, Clindamycin	Cellulitis of right forearm.	Asthma, Migraines.			1						1	Pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~U1866AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246830	11/04/2005	KS	61.0	60		F	11/02/2005	Patient with 6 inch x 3 1/2 inch wheal, red, warm, itching on right arm below deltoid.  Low grade temperature 99, generalized malaise, no shortness of breath or generalized itching.				Y					U	10/31/2005	10/31/2005	0	NONE	OTH	OTH	Estrogen, NSHIDS, PPI	N/A	Allergy to Penicillin, Talwin, Demerol	redness, swelling, itching~Td Adsorbed (no brand name)~~57.00~In Patient		1						1	Erythema; Feeling hot; Malaise; Pruritus; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U1764AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246831	11/04/2005	VA	37.0	36		F	11/02/2005	Itching and burning 30 minutes after injection.  Later in day noted redness and hardness (size of golf ball) at injection site.  This was relieved around 3pm, was told to put ice to area and take Benadryl.  Went to bed early that night due to feeling tired.  Woke up next morning with swelling in neck, chest and numb feeling at base of skull.  Went to see doctor, prescribed prednisone, darvocet, and claritin, continues to have tingling in hand, soreness in neck.  Still has residual side effects.				Y						10/26/2005	10/26/2005	0		PUB	PUB		NONE	Penicillin			1						1	Hypoaesthesia; Injection site erythema; Injection site induration; Paraesthesia; Pruritus; Skin burning sensation; Swelling	FLU3~SANOFI PASTEUR~U1831AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246834	11/04/2005	VA	0.51	0	.5	M	10/31/2005	1. Immunization (Dtap, Hib, Prevnar, Hep B and FluZone) given IM. 2. five hours later started with temp 103.8F 3. held fever > 101 for four days.				Y					Y	10/27/2005	10/27/2005	0		PVT	PVT	NONE	Runny nose	NONE			1						1	Pyrexia	DTAP~SANOFI PASTEUR~C2278AA~3~IM~~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0192R~3~IM~~HEP B (RECOMBIVAX HB)~1|HIBV~SANOFI PASTEUR~UE770AA~3~IM~~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A85856H~3~IM~~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0246835	11/04/2005	WI	6.0	6		F	10/28/2005	Approx 2 min after receiving influenza vaccine patient experience seizure activity lasting approx 10 sec. Patient slumped from chair to floor and seizured with eyes open, facial color was white with scared look on face. Patient examined by Dr. with no injury or lasting effects present. MD felt it was syncope aft anxiety leading to seizures.									Y	10/26/2005	10/26/2005	0		PVT	UNK		NONE	NONE			1						1	Convulsion; Fall; Pallor	FLU3~SANOFI PASTEUR~U1833BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246836	11/04/2005	GA	52.0	51		F	10/27/2005	Itching on legs, red blotchy rash traveled from legs to trunk to arms. No other symptom.				Y					U	10/27/2005	10/27/2005	0		PUB	PVT		NONE	Codeine - gets hives			1						1	Erythema; Pruritus; Rash	FLU3~SANOFI PASTEUR~U1864AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246837	11/04/2005	OH	37.0	36		F	10/31/2005	W/I 48 hrs- Erythema warmth induration right UE to elbow. Fever/ Myalgias/ Malaise				Y					U	10/27/2005	10/28/2005	1		PVT	UNK		NONE	Multiple Sclerosis			1						1	Erythema; Feeling hot; Malaise; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1850AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0790P~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246838	11/04/2005	CT	83.0	83		F	10/31/2005	Fever, arm pain, swelling, URI symptoms									Y	10/28/2005	10/28/2005	0		PVT	PVT		NONE	Osteoporosis			1						1	Pain; Pyrexia; Swelling; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~U1794AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246839	11/04/2005	CA	24.0	23		M	10/28/2005	Reported dizziness approximately 15:25. Sitting 126/66-64-14 Standing 124/86 92-14. Given po fluids and rested x 30 min - symptom resolved. No other adverse reaction									Y	10/28/2005	10/28/2005	0		OTH	PVT	NONE	NONE				1						1	Dizziness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA138BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246840	11/04/2005	CO	4.0	4		F	10/27/2005	Rapid eye blinking. No pain or vision changes C/W optic neuritis.									Y	10/26/2005	10/26/2005	0		PVT	PVT	Gummy Vitamins	NONE	NONE			1						1	Eye disorder; Optic neuritis	FLU3~SANOFI PASTEUR~U1816AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246841	11/04/2005	OH	27.0	26		F	10/31/2005	Unilateral eyelid swelling (upper/lower) symptom onset 24 hr after vaccination									Y	10/27/2005	10/28/2005	1		MIL	MIL	Zocor;Desogen	NONE	NONE			1						1	Eyelid oedema	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0246842	11/04/2005	TX	32.0	31		F	10/28/2005	C/O pain down whole right arm post-immunization; started immediately after she was given the shot. However, it was better the following day. Today C/O pain down whole length of arm worse with movement. She took Advil but it didn't help. She will try heat when she gets home.									U	10/26/2005	10/26/2005	0		PUB	PUB		NONE	NONE			1						1	Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U18052AA~3~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0600R~2~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0246843	11/04/2005	TX	57.0	57		F	11/04/2005	Hives appeared 48 hours after vaccination. They continued to increase in intensity daily for 4 days, despite taking antihistamines. Doctor prescribed prednisone on day 5 of symptoms.				Y					Y	10/24/2005	10/26/2005	2		OTH	PVT						1						1	Urticaria	FLU3~SANOFI PASTEUR~U1792AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246847	11/04/2005	CA	78.0	77		F	11/03/2005	Immediate swelling/badly bruised 4x2/ nodule 1 day post. Visited personal physician 1 day post.				Y					Y	11/02/2005	11/02/2005	0	Personal physician dx an artery had been hit	OTH	OTH	NONE	NONE	NONE			1						1	Contusion; Skin nodule; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61123~7+~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0246848	11/04/2005	CA	58.0	58		F	11/04/2005	Patient claimed she had delayed allergic reaction at site of injection. Claims it was swollen, hot and red about 24 hours after vaccination. Doctor on cruise ship gave Benadryl and swelling went down.									Y	10/14/2005	10/15/2005	1		OTH	PVT	Albuterol;Singulair; Serevent MDI 10mg discuss		Asthma			1						1	Hypersensitivity; Injection site erythema; Injection site reaction; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1848AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246849	11/04/2005	IL	12.0	12		F	11/03/2005	Mom denied prev. illness. Mom, who is an RN, reports chills and fever within 1 hr of vaccine administration, swelling over left deltoid to left elbow and facial hive like rash. During the night results in scratching and fever. Temp of 103. On 11/3 became aware slight erythema swelling along jaw line and extending to neck, palpates left deltoid minimal swelling no erythema from at shoulder/elbow and unaware of any.									Y	11/01/2005	11/01/2005	0	NONE	PVT	PVT		NONE	Ceclor result in Serum Sickness			1						1	Chills; Erythema; Pyrexia; Rash; Swelling; Urticaria	FLU3~SANOFI PASTEUR~U1802AA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246850	11/04/2005	DE	76.0	75		F	11/04/2005	A painful burning on administration, later an aching and heat at site of inj. Loss of mobility, next day - slightly better but a weakness and fatigue.									Y	10/27/2005	10/27/2005	0	NONE	UNK	UNK		Arthritis	NONE Noted			1						1	Asthenia; Fatigue; Injection site warmth; Movement disorder; Pain; Thermal burn	FLU3~SANOFI PASTEUR~U1778AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246869	11/04/2005	TX	35.0	34		F	11/04/2005	Within 1 hour developed soreness, pain, itching at injection site.  Within 24 hours developed systemic itch/rash.  Saw doctor on 11/03/2005, colestone 2cc given intramuscularly, and Zyrtec 1mg by mouth, Eladel cream.				Y					Y	10/19/2005	10/19/2005	0		PVT	PVT	Adipex	NONE	Allergy to codeine			1						1	Injection site reaction; Myalgia; Pain; Pruritus	FLU3~SANOFI PASTEUR~U1806AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246775	11/05/2005	CA	69.0	69		F	10/24/2005	Extreme dizziness first two days now tapering off. Treated with bed rest.									U	10/24/2005	11/02/2005	9		UNK	UNK	Benicar, Zocor, HCTZ	none				1						1	Dizziness	FLU3~SANOFI PASTEUR~01793 AA~UNK~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749D~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246776	11/05/2005	MI	58.0	57		M	11/05/2005	severe chills then extremely hot.  next day very tired and little energy.									U	11/04/2005	11/04/2005	0		UNK	UNK		none	pcn			1						1	Asthenia; Chills; Fatigue; Hot flush	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246777	11/05/2005	NM	54.0	54		F	11/05/2005	Initial pain in neck over next 24-36 hours gradually spreading to shoulder blades and to chest, sharp pain down right arm. Pain unrelieved with tylenol, heat medicated rub, ibuprofen.  Was awake with pain for two night consecutive nights.  When pain in chest became squeezing and very uncomfortable I went to the ER.  EKG and blood tests were normal and heat and anti-inflammatory drugs I was also given a narcotic prescription-Lortab.  I took two of these at two different times with no relief from this or larger doses of ibuprophen Pain gradually diminished over the next two days being almost completely resolved by late Saturday afternoon with some residual fatigue.				Y					U	10/29/2005	10/31/2005	2		UNK	UNK						1						1	Chest pain; Fatigue; Neck pain	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0246778	11/05/2005	LA	67.0	66		F	11/05/2005	Pain upon injection; injection site of the pneumovax was reported as being given in the Left Deltoid.  However, upon inspection, it appears the injection was given sub-acromially.  No redness or swelling at the area, but it is warm to the touch.  The patient is completely unable to abduct her arm.  Pain is extreme.  She was given Celebrex and Tylenol without any relief.  Ice pack was also given.  I am a physician and have examined her myself.  I have never seen this type of reaction before.				Y					U	11/05/2005	11/05/2005	0	None	UNK	UNK	Zebeta 5 mg (1/2)tablet daily Zocor 20 mg daily	None	Hypertension Hyperlipidemia  No Known Drug Allergies			1						1	Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U1756AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246779	11/05/2005	CA	51.0	50		F	11/05/2005	I got the shot at 3:45 pm. At approximately 8 pm I started feeling like I was loosing my voice and I felt like my upper chest was congested and I needed to cough and clear my throat alot.  I also felt a mild sharp pain in my throat when I swallowed that seemed to move around.  I had been to the Dentist at 2:45  that same day so I thought what I was feeling was from that. (I asked the Dentist the next day and he said it was more likely a reaction to the flu shot) These symptoms lasted till about 11 pm (4 hours) I then at 11pm started to feel achy all over  like I had a fever.  I checked my temperature and it was normal.  I went to bed and awoke at 1am feeling hot as if in a oven. I again checked my temperature at 1 am and it was normal.  These symptoms lasted till 5:30 am when both the achy ness and feeling of being hot went away.   I fell back to sleep and when I awoke at around 8 am I felt much better just tired.  Thank You.									Y	11/01/2005	11/01/2005	0	none other than taking my temperature twice and both times it was normal 98.8	UNK	UNK	none just vitamins, baby aspirin	none	heart palpitations.  Allergic to silver nitrate as a baby.			1						1	Dysphonia; Fatigue; Nasal congestion; Pain; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U1771~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246806	11/05/2005	MI	76.0	76		F	11/04/2005	Husband came in on 11/3/05 and said during dinner of day of flu shot, wife passed out and stayed in hospital 1 night. Unsure of any relationship between shot and episode.				Y	Y	1			Y	10/25/2005				OTH	UNK						1						1	Loss of consciousness	FLU3~SANOFI PASTEUR~U1833BA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0246845	11/05/2005	CA	20.0	19		F	11/05/2005	Chest and throat tightness minutes after vaccination - was given epinephrine subcutaneously and anadryl and solumedrol and pepan and zyrtec.				Y					Y	11/05/2005	11/05/2005	0		PVT	OTH						1						1	Chest discomfort; Throat tightness	FLU3~SANOFI PASTEUR~U1745AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246846	11/05/2005	CA	54.0	53		F	11/04/2005	After the flu vaccine patient took advil for the injection pain within 4 hours after the vaccination, patients sclera turned bright red and dry.  The next morning, she developed flu like symptoms and tearing eyes, she took Benadryl by mouth, symptoms improved. Sclera still red.  Patient has had no prior reaction to flu vaccine.  No medical allergy.										11/02/2005	11/02/2005	0	NONE	PUB	PVT	NO	NONE	Bee sting - desensitization			1						1	Erythema	FLU3~SANOFI PASTEUR~U1866AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246780	11/06/2005	MD	56.0	55		F	11/06/2005	Allergic reaction, pressure in chest, difficulty breathing, sinus congestion - most symptoms passed in 24 hours.									Y	11/05/2005	11/05/2005	0		UNK	UNK		None	Allergic to dust, animals (dog/cats)			1						1	Chest pain; Dyspnoea; Hypersensitivity; Sinus congestion	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246781	11/06/2005	NY	42.0	41		F	11/06/2005	RIGHT ARM PAIN STIFFNESS SWELLING HOT REDNESS OCCASSIONAL SHORTNESS OF BREATH				Y					U	11/04/2005	11/05/2005	1		UNK	UNK		NONE	ALLERGIES-ANIMAL, POLLEN, MOLD ASTHMA			1						1	Dyspnoea; Erythema; Injection site warmth; Musculoskeletal stiffness; Pain; Swelling	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246782	11/06/2005	MD	70.0	69		F	11/06/2005	left arm is extremely swollen and red. Unable to use it. Exception typing this form. This was the result from a pneumonia vaccine received 24 hours ago. I have had a penumonia vaccine 5 years ago with no reactions. I have taken Advil and used ice to reduce the swelling, with no results.										11/05/2005	11/05/2005	0		UNK	UNK		perfectly well	none that I'm aware of			1						1	Erythema; Swelling	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0246844	11/06/2005	TX	62.0	61		F	11/06/2005	Red, swollen, and knots below injection site in right arm - soreness that evening with progression.  The following 2 days - patient advised to take antihistamine and use warm compresses.									Y	11/04/2005	11/05/2005	1		OTH	PVT		NONE				1						1	Erythema; Pain; Skin nodule; Swelling	FLU3~SANOFI PASTEUR~U1929AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246160	11/07/2005	OH	29.0	29		F	11/02/2005	Initial report received on 24/Oct/2005 from a health care professional. A 29-year-old female with pre-existing allergies to phenol, Depo-Provera, go-lytely, generic Aleve and the TB Mantoux test, received an intramuscular left arm injection of Fluzone SV 2005-2006, lot number 17773AA, on 19/Oct/2005 at 11:00 am. One hour later, the patient experienced face burning, scratchiness in her throat and shortness of breath. She was examined in an emergency room and treated with intravenous fluids, intravenous Benadryl, intravenous Pepcid, and intravenous Solu-Medrol. doses for these medications were not reported. Subcutaneous epinephrine 0.3 ml (1:1000) was also administered. the patient was discharged from the emergency room with a Medrol Dosepak and prescriptions for Allegra and Pepcid. Relevant diagnostic tests were not reported. Illness at the time of vaccination and other medications were not reported. Per the reporter, this was a life threatening illness. At the time of this report, the patient had recovered.			Y	Y					Y	10/19/2005	10/19/2005	0		PVT	PVT	allergies to phenol, depo-medrol, go-lytely, generic aleve and the tb mantoux test.		The patient had pre-existing allergies to phenol, Depo-Provera, go-lytely, generic Aleve and the TB Mantoux test. The patient denies any food or egg allergies. Illness at the time of vaccination and other medications were not reported.		200502209	1						2	Dyspnoea; Pharyngolaryngeal pain; Skin burning sensation; Dyspnoea; Hypersensitivity; Pharyngolaryngeal pain; Skin burning sensation	FLU3~SANOFI PASTEUR~1773AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1773AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening	Influenza
0246874	11/07/2005	IN	54.0	54		M	11/07/2005	Patient developed cellulitis at the site of the injection in the right arm 1 day after vaccination.  Required a doctors visit, IM antibiotic injection at the clinic and oral antibiotics.				Y					Y	11/01/2005	11/02/2005	1	none	UNK	UNK	none reported	none reported	none reported			1						1	Cellulitis; Injection site reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA141AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1006P~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246875	11/07/2005	MO	41.0	41		F	11/07/2005	Two weeks after the flu vaccination was administered, there suddenly developed a hot spot at the injection site, with localized heat and swelling to about the size of a ping-pong ball.									U	10/25/2005	11/06/2005	12		UNK	UNK	Protonix, Nasonex	None	GERD, Nasal Allergies			1						1	Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246876	11/07/2005	MD	55.0	55		F	11/07/2005	Symptoms appeared apprx. 3 hrs. after receiving shot.  Throat closed up, difficulty breathing - felt like asthma, light headed - dizzy, secretion from eyes and cough.  Later in the day and into the next day, achy all over, eye secretion continued, cough.									Y	11/05/2005	11/05/2005	0		UNK	UNK	Actenol Detrol	None	None			1						1	Asthma; Cough; Dizziness; Dyspnoea; Eye discharge; Pain; Throat tightness	FLU3~SANOFI PASTEUR~U1771AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246879	11/07/2005	CA				F	11/07/2005	Consumer received influenza vaccine 10/11/05 IM to the left thigh.  Staff reported a 19x8cm area on the left thigh which was erythematous, non raised slightly warm to touch on 10/12/05.  No respiratory distress, vital signs normal.  Rash reported as fading by 10/13/05.  No further problems noted after 10/13/05.									Y	10/11/2005	10/12/2005	1	none	UNK	UNK	Multiple vit, Zonisamide, Enalapril, Phenobarbital, Docusate sod.,milk of mag., lansoprazole, calcium Vit D.	none	Epilepsy, Hypertension, osteoporosis, GI bleeding, reactive airway disease.			1						1	Injection site erythema; Injection site warmth; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AfluA138AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246881	11/07/2005	CO	66.0	65		M	11/07/2005	About 12 hours after receiving Pneumovax in right arm, patient experienced redness, swelling, erythema, and pain from right shoulder to forearm.  Patient contacted PCP and was referred to ER.  Patient was diagnosed with cellulitis and began IV antibiotics (drug and dose unknown) and started cephalexin, 500mg PO QID.  After PCP visit, received rocephin 1 gm IM and will continue cephalexin x7 days.				Y					Y	10/19/2005	10/20/2005	1		UNK	UNK	Lipitor 20 mg, Lisinopril 40 mg	No.	Unknown			1						1	Cellulitis; Erythema; Injection site reaction; Pain; Swelling	FLU3~SANOFI PASTEUR~u1905AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246882	11/07/2005	MN	44.0	44		F	11/07/2005	Patient developed apparent cellulitis 2 days after her pneumococcal vaccine injection at the injection site.  She has large, swollen, tender and erythematous area (10cm x 10cm) with a fever.  She was to see her physician 11/4/05 for further evaluation and treatment.				Y					Y	11/02/2005	11/04/2005	2		UNK	UNK	none reported	none reported	thyroid problems, hypertension			1						1	Cellulitis; Injection site erythema; Injection site reaction; Injection site swelling; Pyrexia; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA141AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0577P~2~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246883	11/07/2005	NV	48.0	48		F	11/07/2005	Hypertension, tachycardia, chest pain, severe myalgias with muscle weakness of lower extremities.				Y					Y	11/04/2005	11/05/2005	1		UNK	UNK			Asthma, history of SVT - on Toprol XL, allergy to Versed and Lidocaine as anesthesia agents			1						1	Chest pain; Condition aggravated; Hypertension; Muscular weakness; Myalgia; Tachycardia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AfluA120AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0246884	11/07/2005	MD	13.0	12		F	11/07/2005	AT APPROX 10 PM 11/4/05 CHILD C/O FEVER SHAKING UNCONTROLLABLY, UNABLE TO FOCUS AND NOTED FEVER OF 104. CHILD STATED LATER THAT SHE WAS HAVING TROUBLE BREATHING BUT DID NOT TELL PARENT AT TIME. MOTHER CALLED ER FOR ADVICE BUT DID NOT SEEK TREATMENT AT THAT TIME. SYMPTOMS LASTED ABOUT 12 HOURS.  TODAY CALLED PCP'S OFFICE TO NOTIFY OF EVENT. NO TEMP TODAY MUCH IMPROVED BUT CONTINUES TO BE TIRED. NO FURTHER COMPLAINTS OF SHORTNESS OF BREATH.									Y	11/04/2005	11/04/2005	0		UNK	UNK	NONE	NONE KNOWN	SULFA DRUGS			1						1	Dyspnoea; Mental impairment; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246885	11/07/2005	IN	6.0	6		F	11/01/2005	It appeared that approximately 5 minutes after the vaccines were administered, the patient blacked out, fell backward, and hit her head. When the patient's mother first picked up the child, the patient was not moving. Then the child began to seize, her body was rigid and tightened up. After approximately 2-3 minutes, the patient was able to stand. After standing, the patient vomited twice.				Y					U	10/27/2005	10/27/2005	0	None	UNK	UNK	None	None	None			1						1	Convulsion; Fall; Injury; Loss of consciousness; Musculoskeletal stiffness; Vomiting	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14A006BA~5~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1765GA~5~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0343~4~IM~LL~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0235R~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0246886	11/07/2005	MI	0.86	0	.9	F	11/07/2005	Hives/welts over all of body.  She treated with Prednisone and Benadryl.									Y	11/01/2005	11/02/2005	1		UNK	UNK	client was being treated for bronchitis and was on albuterol, amoxicillian and prednisone.  Dr feels the reaction was from the amoxicillian	bronchitis	none			1						1	Urticaria	FLU3~SANOFI PASTEUR~u1854aa~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246887	11/07/2005	MN	71.0	70		F	11/07/2005	Immediately after receiving the flu vaccine my voice started becoming hoarse.  I also felt woosy.  I sat down and talked to some people I knew and again commented that I seemed to be losing my voice.  I never connected these symptoms to the vaccine until I got home and read the brochure.  I called the nurse who told me to take Benadryl, which I did.									Y	11/04/2005	11/04/2005	0		UNK	UNK		none before being vaccinated	sulfa, iodine, beta blockers, ace inhibitors, some pain medications, codeine			1						1	Dizziness; Dysphonia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246889	11/07/2005	NY	37.0	36		M	11/07/2005	Approximately 2 hours after receiving the vaccine, patient reported feeling pain in his left arm.  By the next morning, he noticed an area of redness approximately 4 inches in diameter, which was warm and sore.  Patient returned to the clinic on Friday, November 4th with the above findings, and was advised to see his private physician.				Y					U	11/02/2005	11/02/2005	0	None	UNK	UNK	None	None	None			1						1	Erythema; Pain	FLU3~SANOFI PASTEUR~U1819AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246890	11/07/2005	CO	50.0	50		F	11/07/2005	Itching at injection site 2 days after, itching torso, scalp, face 3 days after, still itching at 5 days after injection.									U	11/04/2005	11/06/2005	2		UNK	UNK	Elavil 150 mg q hs propranolol 10 mg q am Maxide q am colace 100 mg bid mobic	none	macrodantin-low BP betadine/iodine dye-rash migraines hypertension endometriosis			1						1	Injection site hypersensitivity; Pruritus	FLU3~SANOFI PASTEUR~U1930AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246892	11/07/2005	VT	86.0	85		F	11/07/2005	pt developed allergic reaction to flu vaccine. sx=cough, sore throat, itching.   tx= reversed c benadryl and steroids				Y	Y	1			Y	11/03/2005	11/03/2005	0		UNK	UNK	benadryl and steroids and albuterol udn and ipratropium udn	n/a	has hx of breast cancer among other things.  (predominant hx)			1						1	Cough; Hypersensitivity; Pharyngolaryngeal pain; Pruritus	FLU3~SANOFI PASTEUR~U1815AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0246893	11/07/2005	TX	54.0	54		M	11/07/2005	Fever, upset stomach, dizzy, tired, runny nose, bone aches,									N	11/03/2005	11/04/2006	366		UNK	UNK		None	none			1						1	Dizziness; Fatigue; Pain; Pyrexia; Rhinorrhoea; Stomach discomfort	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246894	11/07/2005	MN	37.0	37		M	11/07/2005	Development of severe tongue pain followed by bilateral hand pain, with subsequent development of petechiae in the terminal tufts of the hands.  The tongue and hand pain subsided after 48 hours.  Petechiae lasted for weeks.  This was likely a mild manifestation of serum sickness.  I had numerous physicians examine me including an Infectious Disease expert.									Y	10/26/2005	10/27/2005	1	Normal CBC w/ diff, and normal ESR.	UNK	UNK	None	None	None			1						1	Glossodynia; Pain; Petechiae; Serum sickness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~5~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246895	11/07/2005	CA	51.0	50		F	11/07/2005	I had 3 vaccinations that same day at the same time: flu, pneumo, and meningococcal. This was about 11:00 AM local time. At about 11:00 PM, that same day, I developed muscle aches and a fever and violent shivering. At about 1:00 AM, I began vomiting, which lasted until 4:30 AM. The shivering stopped after that, but the fever continued throughout the next day (Nov 3). By Nov 4, all symptoms were gone.									Y	11/02/2005	11/02/2005	0	n/a	UNK	UNK		none known				1						1	Chills; Myalgia; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~1~IM~LA~MENINGOCOCCAL (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~3~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246896	11/07/2005	CA	39.0	39		F	11/07/2005	On 11-1-05 at approximately 2000 employee got a localized rash on her arms. She then developed a sore throat, sinus drainage and body aches. She was off of work on 11-4-05 due to her symptoms. She remained afebrile. Today the symptoms have somewhat subsided and she only has a sinus congestion and pressure. No rash or fever.									Y	11/01/2005	11/01/2005	0	none	UNK	UNK		none	none			1						1	Pain; Pharyngolaryngeal pain; Rash; Rhinorrhoea; Sinus congestion	FLU3~SANOFI PASTEUR~U1770AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246898	11/07/2005	DC	8.0	7		M	11/07/2005	11/2 1400 hr. rec'd FluMist in school setting. After school, (@ 1530 hr.) participated in warm up at football practice.  told mother he couldn't breath out and described breathing problem as the air is stuffed in my throat.  Albuteral inhaler used w/ good relief.  Per mother although child is dxed w/ asthma he has never had an attack like this one.  Condition usually presents as wheezing w/ colds in winter that develop into pneumonia (he has had pneumonia 4x).  Child's pediatrician called by mother who advised her to observe him for 24 hours for any recurrence of problem.  Child kept home from school next day w/ no problems observed.  Mother states she didn't read the VIS before signing consent form and was not aware of asthma as a contraindication for LAIV.									Y	11/02/2005			None.	UNK	UNK	Albuterol		Asthma			1						1	Asthma; Dyspnoea; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500392P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0246899	11/07/2005	CA	39.0	39		F	11/07/2005	Approximately 6 hours after receiving flu vac, noticed swelling and numbness of left face/cheek/jaw.  Took diphenhydramine 50mg PO x 1 with improvement.  Numbness and swelling completely resolved within 3 days.  Had received flu vac in the past w/o problems except for local reaction (soreness/redness at injection site), and generalized malaise, body aches.  This time, in addition to pain/soreness/redness at injection site, generalized malaise, body aches, swelling and numbness were also experienced on the left face/cheek/jaw.									Y	11/02/2005	11/02/2005	0	None.	UNK	UNK	None	None	NKDA.  Seasonal allergy taking claritin on occasions as needed.			1						1	Hypoaesthesia; Injection site erythema; Injection site pain; Malaise; Pain; Swelling	FLU3~SANOFI PASTEUR~U1864AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246900	11/07/2005	MN	31.0	30		F	11/07/2005	Right deltoid region there is a 2-3 inch area of induration erythema with superior ecchymoses at the 1 o'clock position.  Function of the deltoid muscle was normal. Oral temp 35.5 Will treat this localized reaction with Benadryl, ice, and NSAIDs as needed for pain control.									U	11/02/2005	11/03/2005	1	None	UNK	UNK	Celexa 10 mg po daily  Albuterol MDI 2p Q4hrs PRN viral colds Nasacort AQ 2 p uffs daily Ortho Novum 1 po daily Tylenol with codeine as directed po prn  Tylenol/Ibuprofen/Excedrin as directed po prn	Asthma Chronic Rhinosinusitis	Thimerosol			1						1	Ecchymosis; Injection site erythema; Injection site induration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA142BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246901	11/07/2005	AK	20.0	20		M	11/07/2005	Noted Nov 6, 2005 to have Papulo vesicular eruption dorsal hands spread up arms to body; few noted on legs; associated with pruritis. Treated with Benadryl.				Y					Y	10/19/2005	11/06/2005	18	CBC WNL	MIL	MIL	none	none	past hx of dermatophytosis			1						1	Pruritus; Rash papular	FLU3~SANOFI PASTEUR~U1839AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020072~1~ID~LA~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0246902	11/07/2005	MI	34.0	33		F	11/07/2005	Dizziness, very pale, weak, cold sweat.  Started about 1-2 minutes after injection at 12:30pm.  Lasted 2-3 minutes.  Rest of day still had upset stomach, severe headache.									Y	11/07/2005	11/07/2005	0		UNK	UNK	Ortho Evra birth control patch		Allergies include cow's milk and peanuts.			1						1	Asthenia; Dizziness; Headache; Hyperhidrosis; Pallor; Stomach discomfort	FLUX~UNKNOWN MANUFACTURER~~1~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246903	11/07/2005	CA	54.0	54		F	11/07/2005	Fever 103 , chills, diaphoresis, tachycardia, cellulitis shoulder, chest, arm and neck, dehydration, elevated liver function tests.  Person giving vaccine said Oops, I am sorry, but patient not sure what happened. Discharge summary states hepatitis, pleural effusion. msv Follow-up: ? MRSA infection.				Y	Y	4			Y	10/31/2005	11/02/2005	2	WBC 15, ALT 155, alk phos 136, AST 66 total bili1.1, CK 195.  Blood cults negative. Discharge summary states leukocytosis, elevated SGOT, SGPT, alkaline phosphataseHypoproteinsem, hyponatremia. msv Medical records state hyperglycemia, hypocalemia, abnormal lab test. msv	UNK	UNK	unknown; Hydrochlorothiazide	None known	Hypertension (Hx of infected draining wound earlier			1						1	Alanine aminotransferase increased; Aspartate aminotransferase increased; Blood alkaline phosphatase increased; Cellulitis; Chills; Dehydration; Hepatitis; Hyperglycaemia; Hyperhidrosis; Hypocalcaemia; Hyponatraemia; Hypoproteinaemia; Laboratory test abnormal; Leukocytosis; Liver function test abnormal; Pleural effusion; Pyrexia; Tachycardia; White blood cell count increased	FLU3~SANOFI PASTEUR~U1929AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0246904	11/07/2005	CO	70.0	70		F	11/07/2005	ALLERGIC REACTION- PATIENT RECEIVED A RED WELT OR HIVE ABOUT 6 INCHES BELOW SIGHT OF INJECTION. PHYSICIAN PRESCRIBED TOPICAL STEROID AND NURSE RECOMMENDED PTN TAKE ORAL ANTIHISTAMINE. Pneumonia vax was also given on same date. Reaction occured on left arm.									Y	10/18/2005				UNK	UNK						1						1	Erythema; Hypersensitivity; Urticaria	FLU3~SANOFI PASTEUR~U1805AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246927	11/07/2005	NY	7.0	7		M	11/02/2005	Initial report received from a health care provider on 10/26/05. A seven year old male with a medical history of asthma received in the left deltoid an injection of Fluzone, lot number U1746AA on 9/19/05. Ten days later, the patient developed slurred speech and left sided mouth dropping. The patient was examined in an emergency room and diagnosed with Bell's Palsy. He was scheduled for an appointment with a neurology clinic, but was totally well by 10/14/05. The patient received a previous dose of Fluzone in December 2004. Other medications and illness at the time of vaccination were not reported. At the time of this report, the patient had recovered.				Y					Y	09/19/2005	09/29/2005	10		UNK	UNK			The patient has a history of asthma. Other medications and illness at the time of vaccination were not reported. The patient had a previous dose of Fluzone in Dec/2004		200502204	1						1	Dysarthria; Facial palsy	FLU3~SANOFI PASTEUR~U1746AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246929	11/07/2005	IL	45.0	45		F	11/02/2005	Initial report received from a health care provider on 10/26/05. A 45 year old female, with an allergy to Iodine and no pre-existing medical conditions, received an injection of Fluzone, lot number U1802BA, on 10/25/05. Annual previous doses of Fluzone were reported with no adverse event following prior vaccination. The route and site of administration were not reported. Ten minutes post-vaccination, the patient developed hoarseness, a tickle in her throat and nasal stuffiness. Twenty minutes post vaccination, she developed a cough with sputum. She was medicated with an epinephrine pen and examined in an emergency room. The patient was thereafter admitted to an intensive care unit. Relevant diagnostic/laboratory tests not reported. At the time of vaccination, other medications were unknown and illness was denied. At the time of this report, the patient remained hospitalized and had not recovered.					Y	0				10/25/2005	10/25/2005	0		UNK	UNK			The patient has an allergy to iodine and no pre-existing medical conditions. At the time of vaccination, other medications were unknown and illness was denied.		200502221	1						1	Cough; Dysphonia; Hypersensitivity; Nasal congestion; Pharyngolaryngeal pain; Productive cough	FLU3~SANOFI PASTEUR~U1802BA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0246930	11/07/2005	IL	59.0	59		M	11/03/2005	Initial report received from a health care professional on 10/27/05. A 59 year old male patient with a medical history of hypertension and an allergy to penicillin received in IM left deltoid injection of Fluzone, lot number U1756AA, on 10/21/05. Within a few hours post vaccination, he developed swelling and pain in the whole left upper extremity and also in the upper anterior chest and left shoulder. Per the reporter, the event required an emergency room/doctor visit and one day of hospitalization. The patient had a normal CBC, CMP and X-ray. The type of x-ray was not specified. The patient had illness at the time of vaccination for a few days, but the specific illness was not reported. The patient takes Diovan 80mg daily. At the time of this report, the patient had recovered.				Y	Y	1			Y	10/21/2005	10/21/2005	0		PVT	PVT	diovan		The patient has a history of hypertension and an allergy to penicillin. He had an unspecified illness at the time of vaccination for a few days. He takes Diovan 80 mg daily.		200502224	1						1	Oedema peripheral; Pain; Shoulder pain	FLU3~SANOFI PASTEUR~U1756AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0246933	11/07/2005	NY	76.0	76		M		Patient presents for weakness, fatigue, generalized muscle ache and upset stomach following flu and pneumonia vaccination yesterday. Also c/o significant tenderness, swelling in area where he received the pneumonia shot. When he received his pneumonia shot he felt a shooting that went down into his 2nd and 3rd digits of the right hand. Has not been monitoring his SMBGs since he has been worried that they will be high. States in currently working with Dr to better controls his BGs which have not been well controlled recently. Const; reports body aches, chills and fatigue. Denies cardiovascular symptoms. Reports productive cough. Assessment: pain in limb, malaise and fatigue hypertension unspec. Sounds like a localized reaction to pneumonia shot and generalized reaction to flu shot. Advised heating pad for localized reaction and will also try lidoderm patches for pain. Discussed with patient that if this is a nerve issue that it may take a while to completely resolve.  Prior to patient leaving his Blood glucose was checked. shortly after that patient began complaining of being very dizzy and became anxious. Became very pale and diaphoretic. Bp was 50/60 with very weak radial pulse. He was lowered to the floor and 911 was immediately activated. EKG done showed no onset of RBBB no other changes. Patient was transferred to the care of the OFD and transported to OH.				Y	Y				Y	10/19/2005	10/20/2005	1	Discharge summary states hyperglycemia; Medical records states Abnormal EKG. msv	UNK	UNK	Accucheck Test Strips; Felexeril; Darvocet; Elocon; Multivitamins; Vitamin E; Vitamin B Complex; Astelin; Novolog Mix; Lancets; Albuterol/Ipratropium Compound; Lantus; Insulin; Prandin; Nasocort; Pulmicort; Aspirin; Tylenol; Vitamin C; Effe		Allergies Ceclor, Diabetes, chronic obstructive pulmonary disease, Hypertension, hyperlipidemia Discharge summary states depression, Medical records state arthritis. msv			1						1	Anxiety; Asthenia; Blood pressure decreased; Dizziness; Electrocardiogram abnormal; Fatigue; Heart rate decreased; Hyperglycaemia; Hyperhidrosis; Hypertension; Injection site oedema; Injection site reaction; Malaise; Myalgia; Pain; Pallor; Stomach discomfort; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU147AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~UNK~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0246934	11/07/2005	VA	33.0	33		F	11/03/2005	Flu shot given left arm, approximately 2 hours later, developed urticaria, itching, severe pain at site radiating to left arm, neck and shoulder. Site bruised and erythematous. Developed edema of hands, paleness with nausea.			Y	Y					Y	11/01/2005	11/01/2005	0		PVT	PVT			Grass, Thyroid Disease.			1						1	Contusion; Injection site erythema; Injection site pain; Nausea; Oedema peripheral; Pain; Pallor; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1777AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0246937	11/07/2005	TX	78.0	78		F		Neuropathy in feet and legs immediately after vaccination administered. Same thing happened 8-10 years ago, Neuropathy lasted 6 yrs. Before letting up. Had the flu last 2 yrs and was bullied into getting this shot bad mistake, I'm 78 years old. Information from medical records includes paresthia and pain. msv								Y	N	10/24/2005	10/24/2005	0	Peripheral neuropathy feet and legs started 1992 lasted 6-8 years.	OTH	OTH	Thyroid		Arthritis, Osteoporosis Information from Medical records states goiter, anxiety. msv	Neuropathy~Influenza (Seasonal) (no brand name)~~69.00~Patient		1						1	Neuropathy; Neuropathy peripheral; Pain; Paraesthesia; Vaccine positive rechallenge	FLU3~AVENTIS PASTEUR~U1817AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0246938	11/07/2005	NY	91.0	90		F		Patient presents for REACTION TO FLU/PNEUOMNIA VACCINE. Patient presents for a possible reaction to pneumonia vaccination. Received Pneumovax yesterday at about 17:00. went home and started to experience severe pain in the arm in which she received her vaccination. Describes as the worst pain she has ever had. Also states that arm became very swollen and red. Patient also received her flu vaccine at the same time and states that she is feeling a little run down with decreased appetite. Reports body aches, fatigue and loss of appetite, but denies fever. Denies cardiovascular symptoms; denies respiratory symptoms; denies nausea and vomiting; denies symptoms other than state above; denies paresthesia and numbness. Appears healthy and well developed. Weighs within the normal range. Alert and oriented.  Resp: Auscultate good airflow. Lungs are clear bilaterally. CV: Rhythm is regular. S1 is normal. S2 is normal. No heart murmur appreciated. Abdomen: soft, nontender, nondistended, no organomegaly. Lymph: No visible or palpable cervical lymphadenopathy. Muscular: Walk with a normal gait. Range of motion in right arm is limited due to pain. There is significant swelling, induration and tenderness along the entire right upper arm with mild erythema. Epitrochlear lymph nodes are not palpable. Distal radial and ulnar pulses are intact and distal sensations are also intact to touch. Will cover with Keflex and advised patient to limit use of arm as much as possible. Will have patient follow-up tomorrow. Advised that if swelling and redness worsen then she is to go directly to the ED or call the office. Will also notify health department in regards to reaction.									Y	10/19/2005				OTH	UNK	Vitamin B6;Hydrochlorothiazide 25mg;Altace 5mg;Aricept 5mg;Premarin .30mg;Centrum A-z;Vitamin C;Vitamin E;Aspirin 81mg;Ditropan XL 15mg;Fosamax 70mg;Keflex;Prevacid		NONE			1						1	Anorexia; Erythema; Fatigue; Hypokinesia; Pain; Swelling; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246939	11/07/2005	NJ	73.0	72		F	11/01/2005	Both Pneumococcal and flu vaccine given right deltoid 1 inch apart. 2 days later right arm red, hot under arm not at site. 10/28/2005 started biaxcin 250 mg BID. Mastectomy left breast 1991. Dx Cellulitis.				Y					Y	10/26/2005	10/28/2005	2		PUB	PVT			PCN, Erythromycin, Keflex, GERD			1						1	Cellulitis; Erythema; Feeling hot	FLU3~SANOFI PASTEUR~U1904AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246940	11/07/2005	MI	49.0	49		F	11/04/2005	Tachycardia, Nausea, Burning Feeling bilateral arms, lightheaded, itching upper legs, Temp 96.5, increased BP 154*114 - 180/110 monitored 5 hours.									Y	11/04/2005	11/04/2005	0	EKG	PVT	PVT	HCTZ, Prevacid, Climara, Allegra, Lipitor, Paxil		Hyperlipidemia, HPTN			1						1	Blood pressure increased; Body temperature decreased; Condition aggravated; Dizziness; Nausea; Pruritus; Skin burning sensation; Tachycardia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA147BA~2~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0246942	11/07/2005	MA	5.0	4		M	11/07/2005	C/O redness, swelling and painful spot on upper left arm.									Y	11/05/2005	11/06/2005	1		PVT	UNK	Qvar	NONE	NONE			1						1	Erythema; Oedema; Pain	FLU3~SANOFI PASTEUR~U17A7AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246943	11/07/2005	VA	36.0	35		F	11/03/2005	Pt came to employee health on 11/03/2005 stating had chest pain 11/02/2005 and now I have a rash. Wheals seen on torso, armpits legs. Denied any SOB. Over the counter Benadryl recommended. No vaccines without MD's recommendations.									Y	11/01/2005	11/02/2005	1	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Chest pain; Rash; Urticaria	FLU3~SANOFI PASTEUR~U1772AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246944	11/07/2005	WA	2.0	2	.0	M	11/07/2005	Emesis started at dinner time 11/05/2005, gassy and abdominal pain evening of 11/05/2005. Increased nasal symptoms, sneezing on 11/07/2005.									U	11/05/2005	11/05/2005	0		PVT	UNK						1						1	Abdominal pain; Flatulence; Sneezing; Vomiting	FLU3~SANOFI PASTEUR~U1743NA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246945	11/07/2005	TX	28.0	28		F	11/07/2005	Tingling of fingers but subsided and is fine now.									Y	11/03/2005	11/03/2005	0		OTH	OTH		NONE	NONE			1						1	Paraesthesia	FLU3~SANOFI PASTEUR~U1929AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246946	11/07/2005	MI	9.0	9		F	11/07/2005	8:45 flu shot given started to school c/o something stuck in her throat difficulty breathing unable to talk clearly slurred speech, wheezing, conjunctiva almost like jelly. By 10:00 pt was getting Decadron epinephrine, and O2 mask (pulse ox 91% on room air). By 11:00 pt had recovered and was going home. Follow up call 11/04/2005 pt fine.									Y	11/03/2005	11/03/2005	0		OTH	OTH	Concerta	NONE				1						1	Aphasia; Dysarthria; Dyspnoea; Eye disorder; Hypoxia; Throat tightness	FLU3~SANOFI PASTEUR~01903AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246947	11/07/2005	IN	2.0	2	.1	M	11/07/2005	hives about 24 hours after flu shot no local reaction. Hives lasted several days, has not had eggs yet. RX Benadryl, No SOB or angio edema, no prednisone needed.				Y					Y	10/28/2005	10/29/2005	1		PVT	OTH	NONE	NONE	mild eczema, asthmatic bronchitis 2-3x 1 yr			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1863AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246948	11/07/2005	PA	67.0	66		F	11/04/2005	Redness, swelling to arm.									Y	11/02/2005	11/02/2005	0		PVT	PVT		NONE	NONE			1						1	Erythema; Oedema	FLU3~SANOFI PASTEUR~U1829AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0529P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246949	11/07/2005	OH	68.0	68		F	10/17/2005	2 hrs intense pain from shoulder, paralysis, 10 of 10 pain ER visit pain Meds, muscles relaxer.				Y					Y	10/10/2005	10/10/2005	0		OTH	OTH	Coumadin		VTE 2 hour surgery			1						1	Pain; Paralysis	FLU3~SANOFI PASTEUR~U1778AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1308P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246950	11/07/2005	IL	55.0	54		F	11/15/2005	Within 2 hours of receiving vaccine I experienced itchy eyes, lump in throat, difficulty in getting enough air, chills, and fever. All were gone within 6 hours.									Y	10/13/2005	10/18/2005	5		UNK	PVT	NONE	NONE	NONE			1						1	Chills; Dyspnoea; Eye disorder; Pruritus; Pyrexia; Throat tightness	FLU3~SANOFI PASTEUR~UNK~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246951	11/07/2005	CO	73.0	73		F	11/05/2005	Erythema multiforme on same arm vaccine flu shot given opposite side. no temp, no other rash or symptoms.									Y	10/26/2005	10/27/2005	1	NONE	OTH	OTH	UNK	NONE	NONE			1						1	Erythema multiforme	FLU3~SANOFI PASTEUR~U1775AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246952	11/07/2005	NC	4.0	3		M	11/07/2005	Inflammatory reaction to flu vaccine Cellulitis, inguinal nodes, swelling, redness and warm to touch. Keflex.				Y					Y	11/02/2005	11/03/2005	1		PVT	PUB						1						1	Cellulitis; Erythema; Feeling hot; Inflammation; Oedema; Skin nodule	FLU3~SANOFI PASTEUR~U1836AA~4~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246953	11/07/2005	MI	5.0	4		M	10/26/2005	Tuesday 10/25/2005 afternoon parents noticed injection site on left thigh with swelling and redness, itching at site. Increasing erythema and induration, but no systemic symptoms.				Y					Y	10/24/2005	10/25/2005	1		PVT	UNK	Miralax	NONE	Microcephaly, Polydactyly, gastroesophageal reflux, seasonal allergies.			1						1	Injection site erythema; Injection site hypersensitivity; Injection site induration; Injection site oedema; Pruritus	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14A006CA~5~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1903AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X0553~4~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0579R~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0246954	11/07/2005	WA	37.0	36		F	10/28/2005	Flu shot given approx 9:30 on 10/27/2005. Client reports 24 hours later that at 17:00 on 10/27/2005 she began itching and noticed hives on her scalp, face, neck, chest. At the time it was reported head and neck rash had resolved, but hives had developed on lower half of body. Client took Benadryl. Reported was concurrently taking erythromycin and almost complete.									Y	10/27/2005	10/27/2005	0		PUB	PUB	Erythromycin	Sinus infection	Environmental allergy molds, also PCN allergies			1						1	Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U1905AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246955	11/07/2005	AK	58.0	57		M	10/11/2005	C/O left arm sore and feeling achy with cold sweats, hot fever interrupting sleep with nausea. Next morning felt better with resolution by evening.									Y	10/07/2005	10/07/2005	0	NONE	PUB	UNK		NONE	Heart disease		AK200581	1						1	Feeling cold; Hyperhidrosis; Nausea; Pain; Pyrexia; Sleep disorder	FLU3~PFIZER\WYETH~U1754AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1|PPV~MERCK & CO. INC.~0456P~1~SC~LA~PNEUMO (PNEUMOVAX)~1|TD~MASS. PUB HLTH BIOL LAB~TD121~UNK~IM~RA~TD ADSORBED (TDVAX)~1	USA		Influenza
0246956	11/07/2005	AK	73.0			F	10/12/2005	Telephone call from the client reporting redness, swelling and discomfort in her upper left arm, in the area where she received the vaccines. Recommended using cold packs and come to the clinic so the PHN could evaluated. Presented with redness below the injection site of the flu and pneumococcal vaccine. The flu vaccine was given above the Pneumococcal vaccine. Noticed the reaction last night. C/O increased discomfort in the area last night and needed to take pain medication. Also took ibuprofen. Reports the area to have been swollen last night. Reports after applying the cold pack before the visit, the swelling has gone down. Redness noted 5 inches x 3 1/2 inches. Redness pattern is irregular. Redness was located more on the anterior part of upper arm. Very slight redness noted in the armpit area. PHN did not feel any swollen lymph. Slight warm to touch. Continue cold packs to the area today 10/12/2005. Switch to heat packs tomorrow, continue taking ibuprofen. Observe for increased redness. Contact PHN this afternoon with concerns. PHN to contact client tomorrow.									U					PUB	PUB		NONE			AK200582	1						1	Discomfort; Feeling hot; Injection site hypersensitivity; Injection site oedema	FLU3~SANOFI PASTEUR~U1754AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~2~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246957	11/07/2005	AK	77.0	77		M	10/13/2005	Pt received flu and pneumo vaccine on 10/11/2005/ By 9pm that night clients left arm was extremely red and swollen past elbow. Wife indicated area looked overweight with folds hanging over. Swelling slowly resolving. Client indicates mild pain but no other symptoms.									Y	10/11/2005	10/11/2005	0		PUB	PUB	Allopurinol				AK200580	1						1	Erythema; Oedema; Pain	FLU3~SANOFI PASTEUR~U1754AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~04569P~2~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246958	11/07/2005	AK	43.0	43		M	10/14/2005	Developed itching at injection site scratching it noticed rash distal to injection site and deltoid next morning 10/12/2005. Red dot non blanching, appears petechial 10/13 no longer itching scabbing at rash sites.									Y	10/11/2005	10/11/2005	0	NONE	PUB	PUB		NONE	Allergic to bee stings local swelling		AK200578	1						1	Injection site hypersensitivity; Injection site rash; Petechiae; Pruritus	FLU3~SANOFI PASTEUR~U1754AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246959	11/07/2005	AK	56.0	56		M	10/21/2005	Flu vaccine administered left deltoid approx 10:30 am patient returned at 11 0.3 epi administered in left deltoid subq. patients right side of upper lip swelling decreased in 30 min. No resp distress rash or itching.									Y	10/06/2005	10/06/2005	0		PUB	PUB					AK200575	1						1	Face oedema	FLU3~SANOFI PASTEUR~U1754AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246960	11/07/2005	AK	74.0	74		M		Pt described dig. SOB 3 days after shot. Exam performed with CBC, chest x-ray, general health panel. Lab pending. Exam normal. I do not believe/support they are related. Pt has had influenza shot in part w/o symptoms or effects.									U	10/19/2005	10/22/2005	3	CBC;Chest x-ray;Good Health Pane O2Sat	PUB	OTH	Many				AK200574	1						1	Dyspnoea	FLU3~SANOFI PASTEUR~U1754AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246961	11/07/2005	AK	67.0	66		M	09/19/2005	Symptoms on Friday 9-16, had fever, achy, fatigue, X 1 1/2 days. Left arm swelling with redness, soreness unable to sleep on throat side. Other left upper arm warm to touch, erythema approximately 13cm X 10cm tender to touch.									Y	09/14/2005	09/16/2005	2	NONE	PUB	PUB		NONE	NONE		AK200572	1						1	Erythema; Fatigue; Feeling hot; Pain; Pharyngolaryngeal pain; Pyrexia; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U1754AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~UNK~SC~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246962	11/07/2005	OR	70.0	69		F	11/05/2005	Temp 100.2, right arm swollen, red, warm - shoulder right should joint rare than muscle painful. Recommend client to call her MD since it was swelling in joint arms not sight of injection.									U	11/01/2005	11/02/2005	1	Sjogrens Syndrome	PUB	UNK	Cortisone, Morthagrm		Sjogrens			1						1	Erythema; Feeling hot; Myalgia; Pyrexia; Sjogren's syndrome; Swelling	FLU3~SANOFI PASTEUR~U1807AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~2~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246963	11/07/2005	NY	6.0	6		M	10/31/2005	Area reddened, swollen, size of 1/2 dollar no tenderness and no itching									Y	10/28/2005	10/29/2005	1		PVT	PVT		NONE	Long arom. of circl syst and Heart/Dysphagia			1						1	Injection site erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~U1846AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246964	11/07/2005	NY	3.0	3		F	10/07/2005	Redness									Y	10/05/2005	10/06/2005	1		PVT	PVT		NONE	Stridor / Congential Arom of inner ear/ Rea Ct airway Dz			1						1	Erythema	FLU3~SANOFI PASTEUR~U1846AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246965	11/07/2005	NY	3.0	3		F	10/24/2005	Redness/swollen									Y	10/20/2005	10/21/2005	1		PVT	PVT		Eye Injury	React Air Dis			1						1	Erythema; Oedema	FLU3~SANOFI PASTEUR~U1846AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246966	11/07/2005	CO	54.0	53		M	10/31/2005	The day after vaccination, patient state that the injection site started to itch almost immediately after injection. He state that injection site itched all evening but had stopped itching by morning.									Y	10/18/2005	10/18/2005	0		OTH	PUB	Propranolol	NONE	PTS;ARDS;polysythemis;sleep apnea			1						1	Hypersensitivity; Pruritus	FLU3~SANOFI PASTEUR~U1755AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246967	11/07/2005	RI	81.0	81		F	10/18/2005	Fever 100.5, chills, fatigue 2 days.									Y	10/05/2005	10/05/2005	0		OTH	UNK		COPD	PCN Erythromycin			1						1	Chills; Fatigue; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0246968	11/07/2005	NY	7.0	7		F	10/31/2005	The day after Flu shot administration the pt developed some swelling of the L pectoralis area, no redness. Had a 1cmX1cm L axillary lymph node.				Y					Y	10/29/2005	10/30/2005	1	CBC w/diff - benign	PVT	UNK		NONE				1						1	Lymphadenopathy; Swelling	FLU3~SANOFI PASTEUR~U1819AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246969	11/07/2005	NY	2.0	2	.5	M	11/02/2005	36 hr later, awoke from sleep, tremulous, hypo responsive, pale face, blue lips and hard (1/2 hr). ER normal exam.				Y					Y	10/31/2005	11/02/2005	2	NONE	PVT	PVT		NONE	NONE			1						1	Cyanosis; Pallor; Peripheral vascular disorder; Stupor; Tremor	FLU3~SANOFI PASTEUR~U17431A~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246970	11/07/2005	GA	79.0	79		F	10/31/2005	Warm to touch, swollen, bruise (purple, yellow) no fever or pain				Y						10/28/2005	10/30/2005	2		PUB	PVT	Blood pressure, Heart		Mitral value prolapse		GA05040	1						1	Contusion; Feeling hot; Swelling	FLU3~SANOFI PASTEUR~U1833BA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246971	11/07/2005	NV	4.0	3		F	10/31/2005	3 inch area - red, hard, swollen and hot to touch.									Y	10/28/2005	10/29/2005	1		PVT	PVT		NONE	Augmentin;Decadron allergies Hx RAD			1						1	Erythema; Feeling hot; Swelling	FLU3~SANOFI PASTEUR~U1863AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246972	11/07/2005	WA	24.0	24		F	11/01/2005	Bright red splotches which coalesced into 1 large hard patch.										10/30/2005	10/30/2005	0		OTH	OTH		NONE	NONE			1						1	Erythema; Injection site induration; Rash maculo-papular	FLU3~SANOFI PASTEUR~U1839AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0246973	11/07/2005	MI	72.0	72		M	10/28/2005	5 hours after flu shot developed acute burning in throat, swelling of tongue and under tongue, and gums. No shortness of breath. Today (the next day) still has sore throat and swollen tongue and gums (false teeth not fitting) and palate				Y					U	10/27/2005	10/27/2005	0	NONE	PUB	PUB						1						1	Glossodynia; Pharyngolaryngeal pain; Swelling	FLU3~SANOFI PASTEUR~U1904AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246974	11/07/2005	CO	53.0	52		F	10/31/2005	Received flu shot on Oct 22nd,2005 inj hurt, red, swollen and began itching 12 hrs post inj. Used Benadryl po and ice packs to site. Was much better 1 day later.									Y	10/22/2005	10/23/2005	1		PUB	PUB	Allegra	Healthy	PCN/Sulfur drugs			1						1	Erythema; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U1755AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246975	11/07/2005	WI	8.0	7		M	10/27/2005	Urticaria 4 hours after vaccine (influenza)									Y	10/26/2005	10/26/2005	0		PVT	UNK		URI				1						1	Urticaria	FLU3~SANOFI PASTEUR~U1861AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246976	11/07/2005	NE	47.0	46		F	11/01/2005	Numbness and tingling in right arm, starting approximately 3-4 weeks ago. Dull pain noted in shoulder area. These symptoms subsided but pain present in right scapular area, radiating up right side of neck, still present.										10/04/2005	10/08/2005	4		PUB	UNK		NONE	NONE			1						1	Hypoaesthesia; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U1832BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246977	11/07/2005	MN	68.0	68		F	11/03/2005	Pain, swelling, redness, warmth at site of injection right arm. Chills. Progressed to cellutites in right arm. Infection on right arm from pneumonia shot. Tenderness				Y						10/13/2005	10/13/2005	0		PVT	PVT			Asymptomatic regarding hypertension;bilateral lower extremity edema;physiologic flow murmur;coronary artery disease;hypothyroidism;gastroesophageal reflux disease;asthma;6 week history of intermittent dry cough;clear postnasal drip.			1						1	Cellulitis; Chills; Infection; Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth; Tenderness; Cellulitis; Chest pain; Chills; Erythema; Feeling hot; Injection site hypersensitivity; Injection site oedema; Injection site pain; Injection site reaction; Muscle disorder; Tenderness; Urine analysis abnormal	FLU3~SANOFI PASTEUR~U1811AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0753P~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U1811AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0753P~2~SC~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0246978	11/07/2005	NY	78.0	77		F	11/02/2005	Bruise and cellulitis at site of vaccination. Redness extended deltoid to elbow				Y					Y	10/26/2005	10/26/2005	0		PVT	UNK		NONE	Rheum arthritis			1						1	Cellulitis; Contusion; Erythema; Injection site reaction	FLU3~SANOFI PASTEUR~U1746AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246979	11/07/2005	OR	0.69	0	.7	M	11/02/2005	102 degrees - 1:00 am -  minus 7 degrees after received shot. Soreness at the site. No redness, or swelling H/A response. Rash/Line elbow.									U	11/01/2005	11/02/2005	1		PUB	PVT	NONE	NONE	NONE			1						1	Injection site reaction; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U1807AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246980	11/07/2005		29.0	28		F	10/27/2005	Pruritus, hives within 5 minutes of vaccination. Given Benadryl 50 mg IM, Symptoms resolved within 30 minutes.				Y					Y	10/27/2005	10/27/2005	0		MIL	MIL	NONE	NONE	Aspirin free analgesics (acetaminophen).	Pruritis~Influenza (Seasonal) (no brand name)~1~0.00~In Patient		1						1	Pruritus; Urticaria; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U1771AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0643P~2~IM~RA~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0246981	11/07/2005	CA				F		Patient developed generalize allergic reaction with itching and hives treated with antihistamine Benadryl she did visit her family Doctor.				Y					Y					UNK	PVT						1						1	Hypersensitivity; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1805AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0246983	11/07/2005	CA	56.0	55		F	11/02/2005	Lightheadedness, near syncope about 20 min after flu shot, while still in clinic. Similar symptoms in recent months independent of today's injection, may be unrelated.									Y	11/02/2005	11/02/2005	0		PVT	PVT	Many		Hyponatremia, currently under evaluation.			1						1	Dizziness; Syncope	FLU3~SANOFI PASTEUR~U1903AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246984	11/07/2005	IA	73.0	72		F	10/26/2005	Report from client left arm was size of baseball, aching down to hands, burning sensation relieved with Benadryl and ice, red, blisters developing sore.				Y						10/24/2005	10/24/2005	0		PVT	UNK		Lung Problems	No lymph nodes right arm call to MD to give in hip and left arm.			1						1	Blister; Erythema; Oedema; Pain; Skin burning sensation	FLU3~SANOFI PASTEUR~U1811AA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0791P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246985	11/07/2005	IA	55.0	54		F	11/03/2005	Increasing soreness in arm starting yesterday treated with ice, ibuprofen, OTC antihistamine today reports welts and can hardly move arm. MD appointment.				Y						10/01/2005	11/02/2005	32		PUB	PVT		NONE				1						1	Hypokinesia; Pain; Urticaria	FLU3~SANOFI PASTEUR~U1806AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0791P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0246986	11/07/2005	WA	45.0	44		F	11/02/2005	Paresthesia lower lip, tingling feeling left arm and leg, painful throat.									Y	11/02/2005	11/02/2005	0		PVT	PVT	NONE					1						1	Paraesthesia; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U1517AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246987	11/07/2005	TX	11.0	11		M	11/02/2005	Left upper arm swollen, red, tender to touch, body aches, headache.				Y						10/31/2005	10/31/2005	0		PVT	PUB		NONE				1						1	Erythema; Headache; Oedema; Pain; Tenderness	FLU3~SANOFI PASTEUR~U1831AB~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1812AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TD~AVENTIS PASTEUR~U1563AA~1~IM~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0246988	11/07/2005	CA	56.0	56		F	10/06/2005	Pt felt right sided nasal congestion after flu vaccine, followed by fell lousy, emesis x1, chest tightness. HX of same when dry weather/winds. Uses inhaler PRN.									U	10/06/2005	10/06/2005	0	NONE	MIL	PUB	Decongestant, Trazodone,Prozac, Wellbutrin, Albuterol inhaler and tobacco	NONE	Environmental allergies with PRN use inhaler			1						1	Chest discomfort; Malaise; Nasal congestion; Vomiting	FLU3~SANOFI PASTEUR~U1829AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0246941	11/08/2005	FL	70.0	70		F	11/07/2005	Pt given both flu and Pneumovax in same arm by persons at CVS pharmacy. Site reaction, body aches, temp. Pt seen in our office 2 days later.										11/05/2005	11/05/2005	0		OTH	OTH						1						1	Injection site reaction; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~UNK~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247018	11/08/2005	VA				F		None Stated														UNK	UNK						1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U1763AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247021	11/08/2005	WV	1.44	1	.4	M	11/03/2005	Patient had fever of 38.2, 11/02/2005 am, upon onset, no fever at home. Also swelling in face and over body which started 11/02/2005 al per mom Fever started when swelling began. Fine red rash over body and pustules in head. DX was allergic reaction to egg in flu, varicella, and rash to hours to MMR. Admitted to Pediatric floor, 11/02/2005 am. DC DX: Allergic Reaction. Admitted with SOB, face and eyelid swollen times 2 weeks. One hour after immunization eye became swollen and discharge (yellow and clear). Temp in ER 99.					Y	1			Y	10/20/2005	11/02/2005	13	Labs: AST 64, ALT 28, CA 8.4 RBC 5.44, lymphocytes 2, atypical lymphocytes 4 Blood culture negative.	PVT	OTH	Tylenol; Nystatin cream	Ebstein anomaly; Plagiocephaly; Spastic upper/lower extremities; Delayed developmental milestones; Out toeing.	Ebstein anomaly; Plagiocephaly; Spastic upper/lower extremities; Delayed developmental milestones; Out toeing.			1						1	Hypersensitivity; Oedema; Pyrexia; Rash; Rash papular	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A020AA~2~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1765FA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE434AA~2~IM~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~1072P~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A98340B~2~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0421K~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0247023	11/08/2005	MI	42.0	41		M	11/03/2005	Patient received his flu shot the afternoon of Tuesday, Oct 25. On Oct 26 he began complaining of a feeling like an abscessed tooth with pain in his left lower jaw. he developed numbness and swelling in his mouth and lips, like a novocaine feeling. he was given Augmentin 875 mg BID on Thursday, Oct 27. He had severe pain, numbness, and swelling in his lower jaw. he actually had swelling in his whole face. His symptoms progressed, and on Sunday, Oct 30, he presented to the ER with very sore eyes. He could not see when he bent over and his eyes were watering a lot. There it was determined that basically he had facial muscle paralysis, he could not move any of the muscles in his face. He could move his jaw up and down and he did have function of his tongue. He could not close his eyes all the way, squint, move the muscles in his forehead, smile, frown, etc. In the ER he underwent a spinal tap, CAT scan, and multiple blood work, and he was admitted for an overnight stay, with a working diagnosis of possible Guillain Barre syndrome. After a neurology consult it was decided that he most likely had a reaction to the flu shot, with his 7th nerve being attacked. He has been placed on prednisone and Famvir with further neurology follow up planned. His neurologist is anticipating a 6 to 12 month recovery period. Information from 60 day follow-up report states: He recovered, hopefully completely, as of mid December. His neurologist feels it was related to the flu shot. Thank you for your interest and your follow up. Discharge summary disproved GBS diagnosis. Medical records state diarrhea.				Y	Y				Y	10/25/2005	10/26/2005	1	Inromation received from Discharge summary states abnormal CSF results.	PVT	OTH	NONE					1						1	CSF test abnormal; Diarrhoea; Eye pain; Face oedema; Facial palsy; Hypersensitivity; Hypoaesthesia; Lacrimation increased; Nerve injury; Ophthalmoplegia; Pain in jaw; Visual disturbance	FLU3~SANOFI PASTEUR~U1804AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0247024	11/08/2005	NC	17.0	16		M	10/20/2005	Fever 103-104 vomiting, sugar increased to 400, all symptoms with in 4 hours time span after receiving vaccine.									Y	10/16/2005	10/16/2005	0		PVT	PVT	Insulin		Diabetes		NC05096	1						1	Blood glucose increased; Condition aggravated; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1742AA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247025	11/08/2005	PA	61.0	60		F	11/08/2005	Developed left axillary adenitis 3 days after receiving flue vaccine in left deltoid.									Y	11/03/2005	11/06/2005	3	NONE	PVT	PVT	Methmin, Diovan, Vytarin.	NONE	NONE			1						1	Inflammation; Lymphadenopathy	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA123BC~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0247026	11/08/2005	MA	36.0	35		F	11/08/2005	Pt received flu shot at work on 10/13/2005, the evening of the flu shot she began to feel tired and started with fevers. Fevers continued through 11/08/2005 ranging 100.5 - 101.3. no UA, no culture no mono no CBC. Please contact her employer where she received the flu shot for this information.									Y	10/13/2005	10/13/2005	0	NONE	OTH	UNK		NONE				1						1	Fatigue; Pyrexia	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247027	11/08/2005	PA	39.0	38		F	11/07/2005	Has received flu shots in past 7 years with no problem. Could not raise arm above shoulder height. By 8:30 pm got headache, chills, temp was normal, took Tylenol and slept for 1 hour. Woke up at 1:30 am with severe chills, shaking 100.9 temp, nausea, vomiting for 1 hour, called doctor who recommended ER if could not keep liquids. Went to ER by 3am. At 4am seen by ER doctor and got IV fluids and anti nausea medication. At 5:30am temperature of 100.8 given Tylenol left at about 6am on 10/30/2005 slept until 1 pm woke up feeling better, a bit tired, but overall fine.				Y					Y	10/29/2005	10/29/2005	0		OTH	PVT	Zoloft			fever vomiting arm pain~DTP (no brand name)~5~5.00~In Patient		1						1	Chills; Fatigue; Headache; Hypokinesia; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1762A~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247028	11/08/2005	IL	70.0	69		F	11/07/2005	Dizzy, weak, pale.  Called doctor but said it was okay because even if blood pressure low not racing, rested all day.  Next day got rash around pneumonia shot.  Took claritin and used hydrocortisone lotion for rash and itchiness, it helped.  Hoarseness started Saturday and continues to today.				Y					Y	11/03/2005	11/04/2005	1		PVT	PUB	Premarin	No	No			1						1	Asthenia; Dizziness; Dysphonia; Flushing; Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0247029	11/08/2005	IL	64.0	64		M	11/07/2005	After 5-6 hours felt tired, felt not dizzy but lacked equilibrium, so hard to walk, mild headache.  Symptoms mild on Saturday and Sunday.  Symptoms hardly noticeable today.									Y	11/04/2005	11/04/2005	0		PVT	OTH	Prednisone, Vitamin E, Protonix, Acupril	NO	Glaucoma, Sarcoidosis, Osteoporosis, Neuropathy.			1						1	Balance disorder; Difficulty in walking; Fatigue; Headache	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247030	11/08/2005	GA	49.0	49		F	11/07/2005	Sore area in the right shoulder area.  Movement also slower or limited.  Hurts with movement or when lying down.  Has gotten worse but not red.  Slightly swollen.									N	10/27/2005	10/28/2005	1	NONE	PVT	PVT	Allegra, Benadryl	Hives	Eczema			1						1	Hypokinesia; Shoulder pain	FLU3~SANOFI PASTEUR~111862AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1006P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247031	11/08/2005	CA	64.0	63		U		Rash at injection site and warmth at left deltoid muscle to touch.  Diphenhydramine and Ibuprofen 3 times a day, helped it subside.									Y	11/01/2005			NONE	OTH	UNK		NONE	NONE			1						1	Feeling hot; Injection site rash	FLU3~SANOFI PASTEUR~U1816AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1046P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247032	11/08/2005	CA	58.0	58		F	11/07/2005	Muscle pain in right arm, rash on right shoulder, trouble breathing.									Y	11/05/2005	11/05/2005	0		OTH	PVT						1						1	Dyspnoea; Myalgia; Rash	FLU3~SANOFI PASTEUR~U1864AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0742P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247033	11/08/2005	IA	38.0	38		F		10/30/2005 Reports experiencing nausea/lack of energy/increased phlegm and some soreness at site.  10/31/2005  Soreness at site, red, swollen at site.  No further nausea and reports other than her arm, she feels okay.  Referred to primary doctor.				Y						10/29/2005	10/30/2005	1	NONE	PUB	UNK		NONE	Chronic Bronchitis, Asthma, Hypertension		IA05015	1						1	Asthenia; Injection site pain; Nausea	FLU3~SANOFI PASTEUR~U1817AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247034	11/08/2005	PA	39.0	39		F	11/07/2005	Felt nauseous at 17:00, progressed to chills, fever, temp not taken, general malaise, muscle aches, headache. Pt had to retire to bed at 20:00. Woke next morning feeling slightly ill, all symptoms resolved by 11:00. Pt took Advil.									Y	11/04/2005	11/04/2005	0		PVT	PVT	NONE	NONE	NONE			1						1	Chills; Headache; Malaise; Myalgia; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~U1849AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247035	11/08/2005	KS	39.0	38		F	11/12/2005	med. rash itching on torso.									U	11/01/2005	11/02/2005	1		PUB	PUB	Entocort, imuran	NONE	Crohn			1						1	Pruritus; Rash	FLU3~EVANS VACCINES~AFUA130AB~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0247036	11/08/2005	VA	67.0	66		F	11/13/2005	Wheezing, shortness of breath, rash on arm and torso.									Y	11/11/2005	11/11/2005	0		PVT	PVT		NONE	Depression, HTN, allergies -tetracycline, PCN, erythymycin, sulfur,skelaxin			1						1	Dyspnoea; Rash; Wheezing	FLU3~SANOFI PASTEUR~U1763AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1046P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247037	11/08/2005	OH		53		F	11/03/2005	Site of vaccine red, hot and patient desribed sore throat/ throat tightness 24 hrs after shot administration.				Y					Y	11/01/2005	11/02/2005	1	NONE	PVT	PVT	Advair, HCTZ, Cozaar	resolving sinusitis	Asthma, HTN, seasonal allergies			1						1	Injection site erythema; Injection site warmth; Pharyngolaryngeal pain; Throat tightness	FLU3~SANOFI PASTEUR~U1850AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247039	11/08/2005	OH	60.0	59		F		Upper arm started swelling in a few hours. The swelling slowly moved down arm to wrist over several days with slight redness. It took a week until the swelling was going. Took Benadryl for several days									Y	10/15/2005	10/15/2005	0		OTH	PVT	Premarin;Synthroid	NONE				1						1	Erythema; Swelling	FLU3~SANOFI PASTEUR~U1792AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749D~2~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247040	11/08/2005	OR	28.0	28		M	11/01/2005	Probable Guillain Barre onset 11 days after flu vaccine administered.  12/27/05 Received medical records 10/20-10/22/2005. Records state decreased reflexes, paresthesia, asthenia, headache, nausea, confusion, hand weakness progressing x 2 days approx 2 wks s/p flu shot. Weakness & difficulty walking progressed s/p d/c & was readmitted 10/24-10/26/2005.  Neuro consult done, demyelinating neuropathy per NCV..  Tx w/IVIG.  No LP done per pt refusal.				Y						10/07/2005	10/18/2005	11	NCV C/W demyelinating polyneuropathy, early  Medical records state LABS: EMG/NCS abnormal.  MRI WNL.	PVT	PVT	NONE	NONE	NONE Medical records state seizure, heat stroke, bone disease.			1						1	Asthenia; Confusional state; Guillain-Barre syndrome; Headache; Nausea; Paraesthesia	FLU3~SANOFI PASTEUR~U1754AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247041	11/08/2005	WI	65.0	65		F	11/02/2005	Patient states she had a golf ball sized, slightly raised red area where injection was given. Lasted one week. Also C/O cough and fatigue. About pt also on Coumadin, states that since being on Coumadin, has not been able to tolerate eggs, usually gets diarrhea. Started Coumadin 1997. Received yrly flu shot since 2000.									Y	10/20/2005	10/20/2005	0	NONE	PVT	PVT	Coumadin;Verapamil;Lipitor;Lisinopril;Ranitidine PCN	NONE	Allergies -ASA;Codeine;Percocet;Sulfa;Morphine;Norflex;Inderal;Zocor;Questran Light AFib;Lipids;HTN;DM;GERN			1						1	Cough; Diarrhoea; Fatigue; Food allergy; Injection site swelling	FLU3~SANOFI PASTEUR~U1756AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247042	11/08/2005	NH	39.0	38		F	11/03/2005	Redness, swelling, warmth and pain 2 days after shot was administered.									U	11/01/2005	11/03/2005	2		OTH	PVT		NONE				1						1	Erythema; Feeling hot; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA147CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0247043	11/08/2005	OH	46.0	45		M	11/02/2005	About 5 hours after receiving influenza vaccine noticed runny nose, chills, nausea, vomiting, and diarrhea. Vomiting stopped by 03:00 10/29/05. Nauseous, diaphoretic and chills lasted 4 days. Took 1 Phenergan supp 10/08/05. Increased fluid / Gatorade. Did not seek emergency treatment.										10/28/2005	10/28/2005	0	NONE	OTH	UNK	Klonopin	NONE	Allergy to Darvocet Hx:restless leg syndrome	same~Influenza (Seasonal) (Fluzone)~1~35.00~In Patient		1						1	Chills; Diarrhoea; Nausea; Rhinorrhoea; Vomiting	FLU3~SANOFI PASTEUR~U1900AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247044	11/08/2005	WA	61.0	61		F	11/01/2005	Low-grade headache, minor upset stomach, very weak, red swelling and fever in right arm, redness spread all around right arm down from shot place and elbow. Very weak till October 28th,05. Eating or drinking anything caused minor stomach upset.									Y	10/18/2005	10/18/2005	0		OTH	OTH	Premarin;Benicar;Poxicam;Doxepin- Methadone for pain.	Nerve damage in spine	Disk disease, Hayfever			1						1	Asthenia; Erythema; Headache; Pyrexia; Stomach discomfort; Swelling	FLU3~SANOFI PASTEUR~U1771AD~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749P~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247047	11/08/2005	OH	26.0	25		F	11/04/2005	Clammy, sweating, dizzy. Ammonia capsule BP 76/50 10/15; P 88; BF 82/70 10/28									Y	11/04/2005	11/04/2005	0		OTH	OTH	Nyquil OTC	Cold sx, cough at night (no fever)	NONE			1						1	Cold sweat; Dizziness; Hyperhidrosis	FLU3~SANOFI PASTEUR~U1773AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247048	11/08/2005	NV	70.0	70		F	11/01/2005	Pneumovax - Swollen, rash, restriction of movement. Started in evening lasted 4 days still itch 11/1/05. Fluarix - light headiness, sweating for 2 rest body. Temp of 108.3 degrees F. Ok today 10/28/05									Y	10/25/2005	10/25/2005	0		OTH	PUB						1						1	Dizziness; Hyperhidrosis; Hypokinesia; Pruritus; Pyrexia; Rash; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA147BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1039P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247049	11/08/2005	TX	39.0	39		F	10/31/2005	Temp 100.2-102. Induration upper right arm 7 x 9 cm, w/erythema painful to touch and when raising arms. No nausea/vomiting/sob. No physical findings for abscess										10/28/2005				PVT	UNK						1						1	Erythema; Injection site induration; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1903AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0747P~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247050	11/08/2005	IL	68.0	67		F	11/02/2005	Burning cough, shallow breathing with itching on outer skin of throat and back. That lasted about an hour. Then had range of fever 99.2-99.8. Felt really cold and sick. Took Tylenol. Fever left at 5:30 am and I got better.									Y	11/01/2005	11/01/2005	0		PVT	UNK	Corgard 40mg;Maxzide37.5/25mg;Synthroid 0.05mg;Lipitor 10mg;Aspirin 81mg;Premarin 0.625mg;Estrace;Flovent 110mg;Nasonex;Hypo tears;Coral Calcium;Muti-Vitamins	Allergy in right eye	Asthma	temp-aches~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Cough; Feeling cold; Hypoventilation; Pruritus; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247051	11/08/2005	IA	7.0	7		M	11/02/2005	Left arm red and swollen. Treat with ice, Benadryl and Keflex 250/5 Tps every 8 hours x 10 days				Y					Y	11/02/2005				PVT	UNK		NONE	Seafood-rash, Gerd, Necrotizing pneumonia and Empyema			1						1	Erythema; Swelling	FLU3~SANOFI PASTEUR~U1756AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1006P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247052	11/08/2005	FL	19.0	19		F		20 min after injection developed hives and itching all over. Gave her Allegra 150mg times 1, Albuterol MDI 2 puffs and Singular 10mg times 1									Y	10/18/2005	10/18/2005	0		PVT	PVT	NONE	NONE	Cholinergic Urticaria			1						1	Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA138AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0247053	11/08/2005	GA	56.0	55		F	11/02/2005	Swelling, erythema, at injection site in left and right deltoid				Y					Y	10/26/2005	10/26/2005	0	CBC- WNL	OTH	OTH	Ziac;Clonidine;Metaglip;Diovan;HCT2	NONE	HTN, DM, IBS (irritable bowel)			1						1	Injection site erythema; Swelling	FLU3~SANOFI PASTEUR~U1826AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~07P1P~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247054	11/08/2005	OH	56.0	55		F	11/03/2005	Swollen left arm, both shots same arm (Oct 27-28 all day and night). Rash on left arm, rash on both breast. Still there Nov 3rd- Flu like symptoms, fever aching body.									Y	10/26/2005	10/28/2005	2		OTH	OTH		NONE	Tetanus/Codeine			1						1	Oedema; Pain; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0247055	11/08/2005	OR	35.0	35		F	11/02/2005	Approximately 10 min after admin pt felt woozy and head was swirly and needed to sit down. Pharmacist called and CMS pt refused transfer and was assisted to her car									Y	10/28/2005	10/28/2005	0	HR;BP;Glucose;Temp all WNL	OTH	PVT	NONE	NONE	NONE			1						1	Dizziness; Vertigo	FLUN3~MEDIMMUNE VACCINES, INC.~500391P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0247056	11/08/2005	AK	55.0	55		M	11/01/2005	Sore throat followed by constricted airway followed by eye redness/discharge followed by mild elevated temperature, chills, and  and  achiness followed by sinus headache. Course: 24 hours.									Y	10/26/2005	10/26/2005	0		OTH	OTH		NONE	NONE			1						1	Eye discharge; Eye inflammation; Pain; Pharyngolaryngeal pain; Pyrexia; Sinus headache; Throat tightness	FLU3~SANOFI PASTEUR~U1754AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247057	11/08/2005	ID	4.0	4		M	11/04/2005	Redness and swelling of upper part of 2 arms. develop. During 40 - 48 hours a prev vaccine. No fever, No pain. Reaction resolved at 72.									Y	11/01/2005	11/03/2005	2		PVT	PUB		NONE	NONE			1						1	Erythema; Swelling	DTP~SANOFI PASTEUR~C2103AA~5~~RA~DTP (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1861AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X0772~4~~RA~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0416P~2~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0247058	11/08/2005	MI	16.0	15		F	11/08/2005	Administered on 10-25-05 3pm, 101.6 temp 10-26-05 6pm. 10-27-05 2 inch red spot right arm and 101 temp 6 am. 10-27-05 reddened area doubled in size by 11 am.  Physician (allergist) notified. Seen by physician at 4pm, size increasing, moving around arm. Tx with augmentin.  Received 2 doses by 10-28-05(16th birthday), fever continues as well as growth of area.  By 10 am 10-28-05 fever 104, arm very hot to touch.  Returned to pediatrician due to close proximity to home as instructed by allergist.  Decision by both physicians to admitto hospital to treat for sever case of cellulitis.  Admitted to hospital. Blood culture , cbc, creatine protein, etc drawn.  Iv clindamycin Q 8hours started at 6 pm x 48 hours.  Discharged 10-30-05 on po clindamycin x 10 days.  The area ended up extending from below the shoulder to just below the elbow and almost encirling the upper arm. Discharge summary states cellulitis. msv				Y	Y	2			Y	10/25/2005	10/26/2005	1	Blood culture, cbc, creactive protein, a few more. Don't have copies. Please contact physician or hospital for full labs. The blood culture was negative.	UNK	UNK	Singular, advair, Qvar, albuterol inhaler prn		scoliosis,tic disorder(tx in past 2-3 yrs, off rx now, improved)asthma			1						1	Cellulitis; Erythema; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0247059	11/08/2005	ME	10.0	10		F	11/08/2005	REDNESS TO L UPPER ARM  THE DAY AFTER VACCINE GIVEN.  OVER WEEKEND INCRESED PAIN AND INCREASE REDNESS.  AREA RED ROUND INDURATED MACULAE AT INJECTION SITE.				Y					U	10/24/2005	10/25/2005	1		UNK	UNK	NONE	NONE	PULMONARY INSUFFICIENCY S/P ASD CLOSURE, PULMICVALVULOPLASTY, MILD MITRAL REGURG.  MODERATE TRICUSPID REGURG, MULTIPLE ECTOPIC HEART BEATS.  SHORT STATURE			1						1	Erythema; Injection site induration; Pain	FLU3~SANOFI PASTEUR~U1746AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~4113R~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0247060	11/08/2005	WV	25.0	24		F	11/08/2005	injection site-warmth, tenderness, aches that lasted 2 days after injection. Resolved without intervention. Joint stiffness in pinky and ring fingers of both hands. Symptoms most severe the 2 days after injection. Joints are still stiff in the a.m. 7 days after the injection.									N	11/01/2005	11/01/2005	0	none	UNK	UNK	none	none	sulfonamides			1						1	Injection site pain; Injection site warmth; Joint stiffness; Pain	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247061	11/08/2005	WV	54.0	54		F	11/08/2005	Patient received flu vaccine 11/03/2005. Telephoned 11/04 AM reporting upper left chest pain and discomfort and numbness down left arm and into fingertips. Reports symptoms have lasted several hours.				Y					Y	11/03/2005	11/04/2005	1	11/07/2005 Patient's states lab work in ER on 11/04 was WNL times two.	UNK	UNK		P.Sclerosing Cholangitis/Crohn's Disease (Mild)	11/07/2005 Patient states she has history of ventricular tachycardia			1						1	Chest pain; Discomfort; Hypoaesthesia	FLU3~SANOFI PASTEUR~U1819AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247062	11/08/2005	NY	59.0	59		F	11/08/2005	BECAME ILL AFTER VACCINE -WEAK- DURING THAT NIGHT HAD SEIZURE- NO FEVER, WHITE COUNT NORMAL,WENT ON TO HAVE SEIZURES, IN INTENSIVE CARE UNIT, SYMPTOMS WORSENED AND CVA SYMPTOMS AND TRANSFERRED TO HOSPITAL.							Y			11/02/2005	11/02/2005	0	PENDING	UNK	UNK	UNKNOWN	DENIED ACUTE ILLNESS	HISTORY OF BREAST CANCER 8-9 YEARS AGO			1						1	Asthenia; Cerebrovascular accident; Convulsion	FLU3~SANOFI PASTEUR~U1904AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0247064	11/08/2005	OH	50.0	49		F	11/08/2005	Patient noted that several hours after receiving the Flu Vaccine, 11/04/05. She broke out with an itching rash,and hives. She called the ER and they recommended that she take benadryl and and cool bath. The next day,11/05/05 she still had the hives and again called the Er. They advised her to continue taking the benadryl, which she did and then slept most of the day and night. On 11/06/05, she woke with a fever(100), aches all over, a swollen upper lip, and broken out further with hurtful hives. Her family took her to the ER about 3:30 P.M. At the ER she as given SoluMedrol 250mg.I.M. She had decreased itching and was given a second dose of SoluMedrol 250mg I.M. She at no time had any respiratory problems or evidence of Hives in her mouth. She was considered stable and was discharged  about one and one/half hours after admission. She was prescribed Prednisone 20mg; six(6) tablets;take twice a day for three days. She was also to followup with her family physician in two days, A telephome call was made to the patient 11/08/05 to check her status. The hives  have diminished and she can only see the outlines at this time. Has an appointment with her family physician 11/08/05 in the P.M.				Y					Y	11/04/2005	11/04/2005	0	Exam by ER physician	UNK	UNK	Lisinopril 1 mg po, every day Lasix 20 mg po every day Synthroid 75 mcg po every day	Reported having a sinus infection the week before, but nothing at the time of the Flu Vaccination	Known allergy to Betadine No reactions to any other vaccines including the Flu vaccine which she has had for at least 10 years. Fibromyalgia, sinus problems, spinal stenosis, and degenerative disc disease			1						1	Face oedema; Pain; Pyrexia; Rash pruritic; Urticaria	FLU3~EVANS VACCINES~61321~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0247065	11/08/2005	MN	39.0			M	11/08/2005	I WAS TOOK THE VACCIN THEN AFTER THREE DAY I WAS SO SICK. I HAD FLUE FOR TWO WEEKS. RUNNING NOSE, HEADACHE, FEVER, LOOSE APPETITES, SNEEZING, COUGHING AND ITCHING THE WHOLE BODY  SINCE THEN NEVER TAKE ANY VACCINE. NOW I AM WORRY ABOUT MY HEALTH. IT IS SO HARD ME TO TAKE THE VACCINE AGAIN.				Y										UNK	UNK						1						1	Anorexia; Cough; Headache; Influenza like illness; Pruritus; Pyrexia; Rhinorrhoea; Sneezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0247066	11/08/2005	MO	76.0	75		F	11/08/2005	(per pt's description) Severe cold symptoms, worst cold ever! Very Congested, very painful throat, couldn't talk. Bronchitis for 10 days (I was perfectly healthy before I received the vaccine) the vacceine made me very sick  (HCP decription) - pt came in and wanted a vaers report filled out. I copied her description into this box. Pt said she was getting over her cold and was doing better. She said she had not come into contact with anyone who was sick.									Y	10/28/2005	11/01/2005	4	N/A	UNK	UNK	Not given	none	none			1						1	Bronchitis; Nasal congestion; Pharyngitis; Pharyngolaryngeal pain; Rhinitis; Speech disorder	FLUN3~MEDIMMUNE VACCINES, INC.~500389P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0247070	11/08/2005	WI	55.0	55		F	11/08/2005	mild weakness & dizziness with associated fever and hoarseness.										11/07/2005	11/08/2005	1		UNK	UNK						1						1	Asthenia; Dizziness; Dysphonia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247071	11/08/2005	IL	57.0	57		M	11/08/2005	Patient said he started getting numb on tips of both feet/toes on Friday Morning.  By Saturday he started getting numb in the shin area and knees.  Sunday numb in waist and hands.  Monday he went to the doctor, stated he couldn't walk.  Dr. sent him to hosp.  He was directly admitted to ICU.  A lumbar puncture was performed and immune globulin started (15 bottles).  protein levels extremely high in spinal fluid.  Hospitalized one week.  Presently has braces on both legs, using a walker, receiving physical therapy.  To follow-up with primary physician in one week.  To follow-up with neurologist in three weeks.  Requesting info on lot # and manufacturer. Information from 60 day follow-up report states: 1/18/06 Spoke with patient regarding recovery status his knees down has no feeling, has regained feeling in thighs with pain consistantly. He has braces on his legs. Presently no therapy is being provided. Physician is estimating recovery to be 6-12 months.  12/29/05 Medical record received for 10/17-10/21/2005 FINAL DX: Guiliain Barre syndrome, dyspnea.  Records reveal patient experienced progressive aching & weakness of legs, numbness of feet & difficulty walking x 2 days & 2 days s/p flu shot.  Reflexes absent.  Neuro & Pulmo consult done, ICU, tx w/IVIG.  Improved & d/c to home.			Y	Y	Y	5			Y	10/13/2005	10/13/2005	0	Medical record states hyperglycemia, abnormal CSF: glucose 90(H), protein 69(H), abnorma EKG.	UNK	UNK			Medical records states hyperlipedemia, diabetis mellatis, hypertension, lymphoma-like event, depression, artherosclerotic heart disease, myocardial infarction.			1						1	CSF test abnormal; Dyspnoea; Electrocardiogram abnormal; Guillain-Barre syndrome; Hyperglycaemia; Hypoaesthesia; Pain	FLU3~SANOFI PASTEUR~u1744AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0247072	11/08/2005	AZ	63.0	63		M	11/08/2005	Nine days after shot, what looked like rash developed and then moved into my mouth as blood blisters. Went to emergency room; blood test showed blood platelet level at 1000. Hospitalized and given Gamma Globulin intravenously, Prednisone and Ranitidine. Was discharged early because of no insurance when platelet level had reached 16000. I am now being seen as an outpatient. Medical records state hematoma. msv			Y	Y	Y	3			N	10/16/2005	10/25/2005	9	Blood tests at hospital. Medical records state thrombocytopenia. msv. 01/04/10 Destroyed my ability to make Plattleto. Have to take large amount of Prednogoma. Leaves me no energy. No can work.	UNK	UNK	None	None	None			1						1	Blood test abnormal; Haematoma; Oropharyngeal blistering; Platelet count decreased; Rash; Thrombocytopenia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFUUA129CB~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Life Threatening,Hospitalisation	Influenza
0247073	11/08/2005	TX	30.0	30		F	11/08/2005	light headed, cold sweat, throw up, weakness, almost black out.									Y	11/08/2005	11/08/2005	0	none	UNK	UNK	none	none	none	sick feeling~Influenza (Seasonal) (no brand name)~1~0.00~In Patient		1						1	Asthenia; Dizziness; Hyperhidrosis; Loss of consciousness; Vomiting	FLUX~UNKNOWN MANUFACTURER~~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247074	11/08/2005	AL	18.0	18		M	11/08/2005	PT CAME TO ER, AFTER RECEIVING FLU SHOT 4DAYS PRIOR, C/O ACHING AND COUGH, FLU LIKE SYMPTOMS.				Y					Y	11/04/2002	11/08/2005	1100	NEG FLU SWAB	UNK	UNK		NONE	NONE			1						1	Cough; Influenza like illness; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0247075	11/08/2005	SD	7.0	6		M	11/08/2005	Hives and welts, treated with antihistimine.										11/07/2005	11/07/2005	0		UNK	UNK						1						1	Urticaria	FLU3~SANOFI PASTEUR~U1838AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247076	11/08/2005	CO	6.0	6		F	11/08/2005	The night of the flu shot her hair started falling out in a mass quantity.									U	10/06/2005	10/06/2005	0	blood test done to check thyroid and iron count both were fine	UNK	UNK			allergic to all tree nuts and Penicillin	face swelled up and rashed out~Influenza (Seasonal) (no brand name)~~9.50~In Sibling|~Influenza (Seasonal) (no brand name)~~0.00		1						1	Alopecia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247081	11/08/2005	LA	8.0	8		F	11/07/2005	After shot given waited 15 min after to see if any reaction, red splotchy noted to left arm where injection was given up to shoulder. 1) L hard.  Noted: Given Benadryl 12.5 mg im and Prelone 2 tsp po.										11/07/2005	11/07/2005	0		PVT	PUB		NONE				1						1	Injection site erythema; Injection site induration; Rash maculo-papular	FLU3~SANOFI PASTEUR~U1830AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247082	11/08/2005	OH	62.0	62		F	11/08/2005	Had shot at 10:30 am flemy cough, hoarseness, fast heat beat. Cough came about 2 hrs after shot - 12:30 pm then hoarseness and then my voice was gone completely about 2:30. Went to ER arrived 4 pm - symptoms cleared up at 5 pm. Called RN and couldn't leave ER before being seen										11/07/2005	11/07/2005	0		PVT	OTH	Prozac 20 mg every day	NONE	NONE			1						1	Cough; Dysphonia; Heart rate increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247085	11/08/2005	AZ	83.0	83		F	11/01/2005	Fever 101 degrees1:57 am. Ache pain, fatigue x 10 days (Hx of COPD)									Y	10/12/2005	10/13/2005	1		OTH	PVT	Inhalers for COPD	COPD				1						1	Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~A129CB~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0247077	11/09/2005	NY	9.0	8		M	11/09/2005	Partial Complex Seizure.				Y					Y	11/08/2005	11/08/2005	0		UNK	UNK		none	Febrile Seizure as toddler			1						1	Condition aggravated; Convulsion	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0247078	11/09/2005	KS	24.0	24		F	11/08/2005	Client called to report an allergic reaction to the influenza vaccine received on 11/07/2005 reported 3 - 4:30 on 11/7/2005 headache, nausea, 6 pm, Body aches 6:30 - 7pm difficulty breathing, vomiting arms numb, face numb, left leg numb, her mother took her to ER. States recovering still difficult walking. To see MD 11/09/2005				Y					U	11/07/2005	11/07/2005	0		PUB	UNK	Albuterol, Lortab, Pepcid	NONE	Asthma			1						1	Difficulty in walking; Dyspnoea; Headache; Hypersensitivity; Hypoaesthesia; Nausea; Pain; Vomiting	FLU3~SANOFI PASTEUR~U1830AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247079	11/09/2005	CA	38.0	38		F	11/03/2005	Fever 101.2, vomiting x 12 hours, raised rash left arm, appears to be local non although rang of motion of left UE limited. No obstruction 90%.										11/02/2005	11/03/2005	1		PVT	PVT						1						1	Joint range of motion decreased; Pyrexia; Rash; Rash maculo-papular; Vomiting	FLU3~SANOFI PASTEUR~U1807AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1006P~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247080	11/09/2005	OR	83.0	83		U		The injection site was warm, swollen and itchy. The swelling had gone down after 24 hours. Pt was instructed to take Benadryl for itching. Allergic reaction to Flu vaccine only.									Y	11/07/2005	11/07/2005	0	NONE	OTH	UNK						1						1	Feeling hot; Injection site oedema; Injection site reaction; Pruritus	FLU3~SANOFI PASTEUR~U1848AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247122	11/09/2005	LA	46.0	46		M	11/08/2005	Joint pain and weakness. Patient is paraplegic and diabetic. Treated with steroids with improvement. Inromation received from Medical records states vasculitis.  Discharge summary states possible Guillain Barre Syndrome; Medical records state wrist pain, edema of arm.				Y	Y	1			N	11/02/2005			Information from medical records states Lab tests abnormal, creatine increased. ESR 40(H).  CPK 660(H).	PVT	PVT		Medical records state viral infection.	Information received from Medical records states diabetes melletes, quadraplegia secondary to MVA, known aneursysm.			1						1	Arthralgia; Blood creatine phosphokinase increased; Laboratory test abnormal; Muscular weakness; Oedema peripheral; Red blood cell sedimentation rate increased; Vasculitis	FLU3~EVANS VACCINES~61503~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0247123	11/09/2005	OH	57.0	56		M	11/09/2005	C/O local burning pain above injection site.									Y	11/09/2005	11/09/2005	0	NONE	OTH	OTH	Folic acid, Zoloft, Allopurinol, Tiazac, Centrum	High cholesterol, high blood pressure, Gout	Codeine allergy			1						1	Injection site pain; Skin burning sensation	FLU3~SANOFI PASTEUR~U1911AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247124	11/09/2005	NJ	22.0	22		F	11/07/2005	Stated felt burning sensation Pneumovax immunization in right arm. On 11/02/2005 had soreness, redness and swelling shoulder, elbow also had rash near elbow area (but not at injection site) Saw MD 11/02/2005 RX Benadryl, Hydrocortisone cefadroxil 500 mg, TC to client states decreased soreness and redness.				Y					Y	11/01/2005	11/01/2005	0		PUB	PUB			delayed gastro reflux, allergies to as lace, lexpro,			1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Rash	FLU3~SANOFI PASTEUR~U1778AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0790P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247125	11/09/2005	NJ	66.0	66		F	10/21/2005	Pt states left arm elbow to shoulder very tender, sore to touch, increases with movement. Denies fever, redness or swelling, With s/s anaphylaxis. Rx Febrile with Tylenol. 10/21 contacted client decreased discomfort now states some soreness slight swelling, persists. Contacted family MD with TX.									U	10/18/2005	10/19/2005	1		PUB	PUB		lymphoma	NKDA, lymphoma			1						1	Anaphylactic reaction; Discomfort; Hypokinesia; Oedema; Pain; Tenderness	FLU3~SANOFI PASTEUR~U1836AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0486P~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247126	11/09/2005	MD	56.0	55		F	11/03/2005	28 hours after getting flu vaccine I developed fever 101, chills, headache, achiness. Lasted for approx 40 hours. Treated with Acetaminophen and cold cloths on forehead.									Y	10/29/2005	10/30/2005	1		PUB	PVT		NONE	NONE			1						1	Chills; Headache; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1836AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247128	11/09/2005	MN	3.0	2	.8	F	11/08/2005	Child was given preservative free vaccine 0.25ml at 11am about on 11/07 and by 6pm she had a fever of 101 and was shaking. She started to vomit by mid night and threw up x 3. She was given clear liquid and was improving by the afternoon of 11/08.									Y	11/07/2005	11/07/2005	0	NONE	PVT	PVT		Serious Otitis Media				1						1	Pyrexia; Tremor; Vomiting	FLU3~SANOFI PASTEUR~U1765GA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247129	11/09/2005	MI	4.0	3		M	11/09/2005	Allergic reaction, localized erythema greater than 10cm.									Y	11/01/2005	11/02/2005	1		PUB	UNK						1						1	Erythema; Hypersensitivity	FLU3~SANOFI PASTEUR~U1762AA~4~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247132	11/09/2005	MI	1.7	1	.7	M	11/09/2005	Child crying and fussy non-stop since day after vaccination.  Date of vaccination 11-3-05.  Afebrile.  No redness or swelling at injection site.  No malaise.  Treated with Advil prn.				Y					Y	11/03/2005	11/04/2005	1	None	UNK	UNK	None	None	None			1						1	Crying; Irritability	FLU3~SANOFI PASTEUR~U17435A~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247134	11/09/2005	SC	43.0	42		M	11/09/2005	Injection given @ ~12:30pm and symptoms were reported as beginning ~2:30p of scratchy throat followed by lips puffing and mouth swelling by 5:00p along with swollen lymph nodes in cervical neck area, and in axillary area bilaterally.  He took Benadryl by mouth X 2 before sleeping, and reports that his symptoms were subsided by this a.m. when he arose.									Y	09/08/2005	09/08/2005	0	None performed	UNK	UNK	Insulin - Humalog, Capoten, Baby ASA	none	insulin dependent diabetic			1						1	Face oedema; Lymphadenopathy; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U1910AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247135	11/09/2005	CA	30.0	29		M	11/09/2005	24-48 hrs after vaccination, developed severe bilateral excrutiatingly painful axillary lymphadanopathy that persisted for 1wk requiring opiates for pain control. Also developed fevers to 102 F, and diffuse myalgias, arthralgias.									Y	11/05/2005	11/06/2005	1		UNK	UNK	paxil, finasteride	none	none			1						1	Arthralgia; Lymphadenopathy; Myalgia; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~5~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247136	11/09/2005	NY	45.0	44		F	11/09/2005	11/8/05: Was given Flu vaccine at 9:30am and broke out in hives at approximately 1:30pm which subsided without medical treatment by 2:30pm. No other signs or symptoms.									Y	11/08/2005	11/08/2005	0	Lungs clear and equal bilaterally on auscultation.	UNK	UNK	no	None	Allergy to Sulfa MVP with regurgitation Renal Calculi x2			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1854AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247137	11/09/2005	NJ	66.0	65		F	11/09/2005	Patient received influenza vaccine at 5PM and developed eye and hand itching at 8PM.  Patient awoke at 4 AM next morning with angioedema of the lip.  Took Claritin with eventual resolution.				Y					Y	11/01/2005	11/01/2005	0	Skin testing to egg white and egg yolk done; 1:10 prick to Fluzone done. All skin tests negative. Serum testing for egg white, egg yolk adn gelatin ordered.  Egg content of Fluzone given requested online from Maxim.  No phone contact available.  Will call Aventis as well.	UNK	UNK	Liptior, Hyzaar, Nexium,	None	Hypertension			1						1	Angioneurotic oedema; Eye irritation; Pruritus	FLU3~SANOFI PASTEUR~U1827AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247138	11/09/2005	MI	59.0	59		F	11/09/2005	One blister (red with raised center, fluid filled)developed on my arm two days after vaccination.  It itched before it developed and while it was present, but the next day it was flat, but still red and did not itch.  The blister never opened.  Now it is the 4th day after the shot, and the red spot remains.									U	11/05/2005	11/06/2005	1		UNK	UNK	Flonase	None	Respiratory allergies			1						1	Blister; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247139	11/09/2005	UT	0.64	0	.6	F	11/09/2005	This patient after receiving Pediarix and Prevnar has had a rash appear on the face and neck.  This has happened every time she has recieved these immunizations at 2,4 and now 6 months. CDC stated that no action needed to be taken. No treatment was administered.  The CDC stated that it is an unsual reaction to have occur with either of these immunizations.  Therefore this reaction is not life threatning and should not prohibit this patient from receiving any further immunizations.  The risk of any of the diseases out weighs the risk of the rash.				Y					Y	11/08/2005	11/08/2005	0		UNK	UNK	None	None	None			1						1	Rash; Similar reaction on previous exposure to drug	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A008AA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1863AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A25964E~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0247140	11/09/2005	AZ	49.0	48		F	11/09/2005	November 7, 2005 1. Rec'd vaccine at 9:15 am 2. Approx. 7:30 pm felt a bit dizzy 3. Approx. 8:00 pm became extremely dizzy & nauseated and walking was impaired 4. Immediately went to bed; woke at 10 pm and placed call to physician on call - no response 5. Next morning I had a large red welt at the injection site with no muscle pain or any other symptoms. 6. Called Dr next day to report reaction									U	11/07/2005	11/07/2005	0		UNK	UNK	20 mg Prozac daily 10 mg Singular daily	None	Ceclor			1						1	Difficulty in walking; Dizziness; Injection site erythema; Nausea; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247142	11/09/2005	SD	38.0	37		F	11/09/2005	The client was given a flu vaccine 0.5cc IM left deltoid at 1115 on 11-7-05.  At 1230, she returned to the vaccine site and reported that she was experiencing itching of her left arm from elbow to shoulder and was feeling hot all over.  The vaccine site had an induration of about 15mm with redness of about 30 mm.  She denied any shortness of breath. Her blood pressure was 116/82, pulse 72; Benadryl 50 mg given IM in right deltoid and ice applied to the affected area.  She remained at the clinic site for 30 minutes (blood pressure at 1247 114/80, pulse 82; at 1305 112/76, pulse 80)and then was walked back to her work station at SDSU nursing department, where she had nurses nearby to assist if she had further symptoms.										11/07/2005	11/07/2005	0		UNK	UNK	Benicar 20 mg qd Amoxicillin 500mg qd		Has idiopathic thrombocytopenic purpura; had spleen removed 5-03.			1						1	Injection site erythema; Injection site induration; Pruritus	FLU3~SANOFI PASTEUR~U1838AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247143	11/09/2005	MO	1.81	1	.8	M	11/04/2005	Patient had allergy symptoms and mild exacerbation of asthma 4 to 5 days prior to flu shot requiring bronchodilator to be added to his maintenance inhaled steroid. After flu shot at 9:20 AM observed until 9:45 AM. Came back to office at 10:00 AM with tight frequent cough without wheeze. Oxygen saturation initially borderline. Benedryl, Orapred, Xopenex given with increased oxygen saturation, decreased cough. Patient admited for observations.				Y	Y	1			Y	10/19/2005	10/19/2005	0	Admitted to hospital for monitoring. Observed overnight and discharged without problems. No tests or labs.	UNK	UNK	Pulmicort 0.5 Bio innebulizer Xopenex 1.25 Bio pm innebulizer	Allergy symptoms, wheezing intermittently	Asthma, history of hives with eggs		MO2005040	1						1	Asthma; Condition aggravated; Cough; Hypoxia	FLU3~SANOFI PASTEUR~U1787CA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0247144	11/09/2005	SD	52.0	51		F	11/09/2005	Flu vaccine given L deltoid at 0950; client says could feel it going down her arm.  At 1030 she reported feeling a choking feeling and at 1045 returned ambulatory to the vaccine site.  Her B/P was 130/76, pulse 68.  She denied difficulty breathing and did not appear in distress.  At 1050, she reported the choking feeling was no better, so Benadryl 50 mg was given IM Right deltoid.  At 1102, her B/P was 112/80.  She was observed and did not seem in more distress but said that the feeling was not subsiding, so a call was made to the emergency room with the PA there advising giving Epinephrine.  Epinephrine 1:1000 1mg/1ml 0.5 ml given SQ right arm per standing order.  B/P at 1132 was 112/76, pulse 72.  Patient was transported per car to the ER.				Y					Y	11/08/2005	11/08/2005	0		UNK	UNK						1						1	Choking	FLU3~SANOFI PASTEUR~U1838AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247145	11/09/2005	MN	1.93	1	.9	F	11/09/2005	Recieved flu shot Friday October 28th at 10am and by monday morning until wednesday morning had a temperature that hovered between 102 to 104 degrees.									Y	10/28/2005	10/30/2005	2		UNK	UNK		None	none			1						1	Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0247146	11/09/2005	SD	35.0	34		F	11/09/2005	Received flu vaccine IM left deltoid at 1130; at 1140 reported that her throat felt swollen and she was light headed.  Her B/P was 90/60.  Epinephrine 1:1000 1mg/1ml 0.5cc given SQ in right arm at 1146.  Benadryl 50mg given IM right deltoid at 1152.  At 1153 B/P was 110/56, pulse 88, lungs clear.  At 1156 lungs clear, B/P 112/68, pulse 80.  Client was transported per private car to ER.				Y					Y	11/08/2005	11/08/2005	0		UNK	UNK		none				1						1	Dizziness; Pharyngeal oedema	FLU3~SANOFI PASTEUR~U1838AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247148	11/09/2005	CA	43.0	42		F	11/09/2005	It began as what I thought was a headache until I realized the pain was in my eye socket, similar to symptoms of the flu that I've experienced in the past. I did not have fever. I felt pain when I made facial expressions like when I yawned; when I leaned forward, bending over to pick up things; when I would lay down on my left side, causing pressure to the left eye socket; and when I rubbed my left eye.									Y	10/17/2005	10/19/2005	2	NONE	UNK	UNK		NONE	Asthma, allergies to grasses, weeds, and trees, IBS (Irritable Bowel Syndrome), a small sliding hiatal hernia.			1						1	Eye pain; Headache	FLU3~SANOFI PASTEUR~U1745AA~1~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247150	11/09/2005	WA	68.0	68		M	11/09/2005	High temperature (101.7) for several hours; could not bring down with Tylenol/Aspirin.  Called Doctor at home; prescribed Benedryl.  Within 4 hours, temp down, feeling better.  Finally well 2 days later; quite weak, though.									Y	10/19/2005	10/19/2005	0		UNK	UNK	Lipitor, Lisinopril, Hydrocodone for knee pain (total knee replacement 2 weeks prior)	None	Total knee replacement, September 26, 2005; on hydrocodone for pain			1						1	Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~ID~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~ID~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0247160	11/09/2005	MD	56.0	55		F		Fever, chills, redness at injection site. Tylenol, rest, and ice to site.									Y	11/04/2005	11/04/2005	0	NONE	UNK	UNK		NONE	NONE			1						1	Chills; Injection site hypersensitivity; Pyrexia	FLU3~SANOFI PASTEUR~U1826AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247161	11/09/2005	IN	46.0	46		F	11/04/2005	Alot of chest congestion, wheezing, fever, aches, stopped up nose, flushed. sore throat.									Y	10/26/2005	10/28/2005	2	NONE	OTH	OTH	NONE	NONE	Asthma, seasonal allergies			1						1	Flushing; Nasal congestion; Pain; Pharyngolaryngeal pain; Pyrexia; Wheezing	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247162	11/09/2005	GA	73.0	73		F	11/05/2005	Swelling of arm, discolored, pain from shoulder to fingers. Per emergency doctor Cellulitis.				Y					Y	10/23/2005	10/23/2005	0		PUB	OTH		NONE				1						1	Cellulitis; Oedema; Pain; Skin discolouration	FLU3~SANOFI PASTEUR~U712AA~5~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~4006P~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247163	11/09/2005	GA	79.0	78		F		I requested flu shot. Given at  9am Oct 27 2005. Before noon, I had excruciating pain all over head. I have had head pain (chronic) over the late years, but this just added a great deal of pain. Phones Dr office. on Mon Oct 31, saw Dr he added medication I was already taking.									Y	10/27/2005	10/27/2005	0		PVT	UNK			Chronic head pain			1						1	Condition aggravated; Headache	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247164	11/09/2005	UT	47.0	47		F		Deep continuous cough, very tight lungs and throat, hoarseness, hard to breath deep, this started about 5 hours after vaccine was given. Called Dr office, told to go to ER but I took Benadryl, after 1 hour symptoms lessened.									Y	10/28/2005	10/28/2005	0		PUB	UNK		NONE	Cipro, codeine, Iodine.			1						1	Cough; Dysphonia; Dyspnoea; Lung disorder; Throat tightness	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~UNK~UNK~~UN~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0247165	11/09/2005	ME	51.0	50		F	11/08/2005	One hour after receiving influenza vaccine. Felt an itch at injection site and noticed one raised red area by the injection site. Benadryl 25 mg PO taken. Raised area resolved at 10/09/2005.									Y	11/08/2005	11/08/2005	0		PUB	PVT	Toporol					1						1	Injection site hypersensitivity; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U1912AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247166	11/09/2005	NE	85.0	84		F	11/07/2005	10/24/05 Redness and pain in left shoulder where Pneumovax was given. Cold packs, ibuprofen, Benadryl; recommended if worsening of symptoms to see physician. 11/03, early AM, admitted to hospital for shortness of breath and rales per patient's daughter. Released from hospital following day.					Y	1			U	10/23/2005	10/24/2005	1	UNK, Possibly chest X ray	OTH	PVT	Amarul, HCTZ, Isosorbide, Toprol		Coronary Artery Disease, Diabetes Type II, Benign Pancreatic mass.			1						1	Dyspnoea; Erythema; Pain; Rales; Chest pain; Chills; Drug ineffective; Dyspnoea; Erythema; Infection; Injection site hypersensitivity; Injection site oedema; Nausea; Oedema peripheral; Pneumonia; Pyrexia; Rales	FLU3~SANOFI PASTEUR~01806AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0791P~2~IM~LA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~0791P~2~IM~UN~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0247179	11/10/2005	ME	59.0	59		M	11/10/2005	Possible Cellulitis to right arm. Pt states 4 hours after receiving vaccine arm started to swell up. Favor just an allergic reaction.									Y	11/08/2005	11/08/2005	0	Physical exam only.	PVT	UNK		NONE	NONE			1						1	Cellulitis; Hypersensitivity; Oedema	FLU3~SANOFI PASTEUR~U1826AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0605P~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247180	11/10/2005	CA	37.0	36		F	11/09/2005	Vaccine given 14:30. At 19:30 started to have runny nose, watery eyes, nausea and vomiting. Also, throat closing, rashes on face, ears and down her throat. Temperature 98 ; BP 162/54; Pulse 110; Respiration = 30. At 22:45 taken to ER and was given IV Benadryl. Came back to work the following day with symptoms resolved.				Y					Y	11/04/2005	11/04/2005	0	NONE	PUB	PUB		NONE	None Known			1						1	Lacrimation increased; Nausea; Rash; Rhinorrhoea; Throat tightness; Vomiting	FLU3~SANOFI PASTEUR~U1825CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247181	11/10/2005	CA	34.0	34		F	11/09/2005	The shot was given at 11 am, at 12:45, the employee started feeling warm (hot flushes), sick to stomach,and lightheaded. No shortness of breath, no rashes and vital signs stable. Patient sent home to rest.									Y	11/08/2005	11/08/2005	0	NONE	PUB	PUB		NONE	None Known			1						1	Dizziness; Feeling hot; Hot flush; Nausea	FLU3~SANOFI PASTEUR~U1825CA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247182	11/10/2005	ID	2.0	2	.2	F	10/24/2005	Reddened; swollen area at injection site on right thigh. Onset was 34 hours prior to office visit on 10/21/05.				Y					Y	10/19/2005	10/20/2005	1		PVT	PUB	NONE	NONE	NONE		ID05041	1						1	Injection site erythema; Injection site swelling	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC1B025AA~2~~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0481R~3~~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0302R~1~~LL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|PNC~PFIZER\WYETH~A56117H~3~~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0247183	11/10/2005	ID	28.0	27		F	10/17/2005	3 inch area of redness around site where vaccine given. It is also itchy and a little warm to the touch. It is the left upper arm.									Y	10/14/2005	10/14/2005	0	N/A	PUB	PUB	N/A	NONE	NONE		ID05038	1						1	Injection site erythema; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U1805AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247184	11/10/2005	OK	42.0	42		F	11/07/2005	Swollen, red, painful (1 inch diameter around injection site.) Treated with Tylenol									Y	11/04/2005	11/04/2005	0		MIL	MIL	Motrin, Benadryl		Sulfa,  PCN			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1839AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247185	11/10/2005	WA	68.0	67		F		3pm Left Upper arm seems swollen and hot 4pm Left Upper arm became sore and painful couldn't sleep due to pain that night 8pm Ran a fever over 101 degree for 2 days; soreness and fever gradually diminished and was gone by October 31 ( No reaction on right arm where flu shot was given)									Y	10/27/2005	10/27/2005	0		OTH	PUB	Lipitor, Tylenol		Arthritis, High Cholesterol			1						1	Feeling hot; Pain; Pyrexia; Swelling	FLUX~UNKNOWN MANUFACTURER~~7+~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0247187	11/10/2005	CA	1.03	1	.0	F	11/02/2005	Febrile seizure 24 hours after immunization Information from medical records states fever, vomiting, diarrhea. msv									Y	10/24/2005	10/25/2005	1		PVT	UNK						1						1	Diarrhoea; Febrile convulsion; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1818AB~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0643R~3~IM~RL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0240R~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0247188	11/10/2005	TX	22.0	21		F	11/03/2005	High Fevers for 3 days; cough, sore throat, body aches.									Y	10/28/2005	10/29/2005	1	CBC, Sed Rate, Chest X-ray, UA	PVT	PUB						1						1	Chest X-ray; Cough; Full blood count; Pain; Pharyngolaryngeal pain; Pyrexia; Red blood cell sedimentation rate; Urine analysis	FLU3~SANOFI PASTEUR~U1761AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247189	11/10/2005	NY	76.0	76		F	11/01/2005	Patient showed immediate reaction to Fluzone shot in left Deltoid. Immediate rash and redness. Gave patient 1 time a 25mg Benadryl 1 General and 1 to take when she got home (drowsiness issue)- Applied ice pack 15 minutes- swelling and redness decreased- told patient to let us know if problem persist.									Y	11/01/2005	11/01/2005	0		OTH	OTH			Asthma- non effected			1						1	Injection site hypersensitivity; Injection site oedema; Injection site rash	FLU3~SANOFI PASTEUR~U1P33BA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247190	11/10/2005	WI	68.0	67		F	11/07/2005	Sub dermal test site became red inflamed burning itching, ice placed to area (1/2) dose test site									Y	10/18/2005	10/18/2005	0		PVT	UNK			PAN, Keflex, Codeine, Bactrim			1						1	Erythema; Injection site inflammation; Pruritus; Skin burning sensation	FLU3~SANOFI PASTEUR~U1839AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247191	11/10/2005	WI	68.0	68		F	11/04/2005	Sore arms the following day and right arm was red from elbow to the shoulder. M.D. ordered antibiotic.				Y					Y	10/24/2005	10/25/2005	1		OTH	PUB						1						1	Injection site hypersensitivity; Pain	FLU3~SANOFI PASTEUR~U1838AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0607R~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247192	11/10/2005	ME	1.35	1	.3	M	11/04/2005	High fever, Tmax 105 degrees. Febrile seizure. Total symptoms 48 hours. Medical records state viral infection, agitation. msv				Y					Y	10/27/2005	10/28/2005	1	One Arc Zaqo and Cu The: -	PVT	PUB	Gantrism		GER, Bronchitis, Prematurity ( 34 5-7 week Premature)			1						1	Agitation; Febrile convulsion; Pyrexia; Viral infection	DTAP~SANOFI PASTEUR~U1396CA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1787BA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0085R~3~IM~LL~HIB (PEDVAXHIB)~1|IPV~SANOFI PASTEUR~Y0425~3~SC~RL~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0247193	11/10/2005	PA	42.0	41		M	10/31/2005	Fever, decrease range of motion right arm, fatigue, low back pain, 2.5 cm erythema lateral arm at sq. site. tender axillary- RX- Ibuprofen; Claritin B,D 2 pack;									Y	10/25/2005	10/26/2005	1		PVT	PVT						1						1	Back pain; Fatigue; Injection site erythema; Joint range of motion decreased; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~U1762AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1006M~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247194	11/10/2005	MD	61.0	61		F	11/08/2005	Developed rash, Red welts in head, lower back and legs with itching about 10 hours after vaccine given.									Y	11/07/2005	11/07/2005	0	NONE	PUB	PUB	Aciphex, Lescol XL, Tenoretic, Serax, Aricept,		PCN hives			1						1	Erythema; Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U1747AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247195	11/10/2005	MN	28.0	28		F	11/04/2005	Rt arm painful. Red and warm.				Y					N	11/01/2005	11/02/2005	1		PVT	PVT	Alesse, Advair,Albuterol Inhaler, Vi Active, Aleve/Ibuprophen					1						1	Erythema; Feeling hot; Pain	FLU3~SANOFI PASTEUR~U1814AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0605R~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247196	11/10/2005	MN	60.0	60		F		11/03/2005 pt phones with reaction to pneumococcal injection received injection left arm on 10/31, that evening had pain under arm, tired, nausea, chills, achy on 11/01 had increased pain left arm inside of arm had redness and red blotchy area on left breast, no redness or swelling at injection site. Yesterday tenderness pain resolved, redness fading, slight brownish tinge where redness was on breast informed to observe if worsen again needs to be seen. Vaccine reaction form mailed per Dr.									Y	10/31/2005	10/31/2005	0		PVT	PVT						1						1	Chills; Erythema; Fatigue; Injection site reaction; Nausea; Pain; Rash macular; Skin discolouration; Tenderness	FLU3~SANOFI PASTEUR~U1814AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0753P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247197	11/10/2005	MA	51.0	50		F	10/12/2005	Left arm at site redness, hot to touch, pain. Local reaction 10 cm x 10 cm. Referred to Dr tomorrow if no better.										10/11/2005	10/11/2005	0		PVT	PUB						1						1	Injection site hypersensitivity; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~UNK~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247198	11/10/2005	OH	29.0	28		F		Flu shot left arm covered with band aid over nite, Next day removed band aid and has small blister at injection site. Filled with yellow fluid. Area not red, no pain, no warm to touch. First flu shot not allergic to latex, alcohol or band aid adhesive.									Y	10/27/2005	10/28/2005	1		OTH	PVT		NONE				1						1	Fluid retention; Injection site vesicles	FLU3~SANOFI PASTEUR~U1846AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247221	11/10/2005	GA	46.0	45		F	11/10/2005	Site swelling and raised fluid filled vesicle 15 mm in circumference and 2 mm in height. Approximately the size of a dime coin.									U	11/10/2005	11/10/2005	0	None	UNK	UNK	None	None	None			1						1	Injection site swelling; Injection site vesicles	FLU3~SANOFI PASTEUR~U1839AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247222	11/10/2005	NY	51.0	50		F	11/10/2005	At approximately 3 AM on 11/02/05, patient deloped a rash on her right arm that felt like bug bites.  Rash persisted on right arm and was itchy.  On 11/04/05, patient started taking Benadryl tablets and itching and rash resolved within 2 days.									Y	11/01/2005	11/02/2005	1	None	UNK	UNK	None	None	None			1						1	Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~61503~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247223	11/10/2005	WI	64.0	64		M	11/10/2005	Approximately 6 hours after flu shot was administered (shot was not administered at the address listed above, it was done as part of the Shoo the Flu program), I began to feel lightheaded, my heart felt like it was racing, and I found myself unable to get a good breath. I have had asthma for most of my life, but this felt nothing like an asthma attack.  My wife took me to the ER, where they determined that I had some kind of reaction to the shot, since EKG, electrolytes, heart beat, pulse, and blood pressure were all normal. I was given an IV drip with Benadryl and the symptoms disappeared. No further symptoms emerged later.				Y					Y	11/09/2005	11/09/2005	0	EKG Blood tests for electrolyte levels Vitals	UNK	UNK	Klonopin - .25 mg per day Prilosec - as needed	None	GERD Allergies - early trees, pet dander sinusitis situational anxiety			1						1	Dizziness; Dyspnoea; Heart rate increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0247228	11/10/2005	CO	57.0	56		F	11/10/2005	This case was reported by a nurse and described the occurrence of shingles in a 56 year old female subject who was vaccinated with Fluarix for prophylaxis. Medical history included non-smoker and moderate consumption of alcohol. On 11 October 2005 the subject received a dose of Fluarix in the right arm (lot number not provided). The nurse reported that the subject, has had flu shots in previous years. On 11 October 2005, at an unspecified time following the administration of Fluarix, the subject experienced, right arm pain. On 13 October, 2 days after vaccination with Fluarix, the subject experienced pain and itching of the arm, thigh, back and buttock all on the right side of the body. The subject was seen at a physician's office on 14 October 2005, was diagnosed with shingles. The nurse considered the shingles to require clinical intervention (OMIC) and to jeopardize the subject. At the time of follow-up reporting, 09 November 2005, the shingles had improved, the arm pain resolved, and the pain in the right thigh, back and buttock were still present. The nurse considered the events to possibly be related to vaccination with Fluarix and stated that, the flu shot may have precipitated immune response, then the subject got shingles.				Y					N	10/11/2005	10/11/2005	0		PVT	PVT					A0579623A	1						1	Back pain; Herpes zoster; Infection; Injection site pain; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0247232	11/10/2005	MI	84.0	84		F	11/10/2005	Developed cellulitis around injection site within hours of injection which spread down to wrist. Required ER visit and subsequently admission for IV antibiotics. Information from medical records states chills. msv					Y				Y	11/07/2005	11/07/2005	0	information from medical records states anemia. msv	PVT	PVT	Coumadin; Atenolol; Premarin		Skelaxin; Iodine; Codeine; Phenergan; Atrial fibrillation Information from medical records states pancreatitis, carcinoma of skin, hypertension, dementia, GI distress, hyperlipedemia. msv			1						1	Anaemia; Cellulitis; Chills; Injection site reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61503~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0973~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0247233	11/10/2005	MI	85.0	84		M	11/10/2005	Developed cellulitis around injection site spreading down arm. Was seen in ER sent home on oral antibiotics after a course of IV antibiotics overnight.				Y					Y	11/07/2005	11/07/2005	0		PVT	PVT		NONE	NONE			1						1	Cellulitis; Injection site reaction	FLUX~UNKNOWN MANUFACTURER~061503~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0975P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247234	11/10/2005	OH	70.0	69		F	11/10/2005	Swelling, redness,severe degree also of right arm.				Y					Y	10/31/2005	10/31/2005	0	None examination	OTH	OTH		NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U1825BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0512P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247235	11/10/2005	TN	3.0	3		F	11/10/2005	Urticaria face, trunk and extremities, no wheezing no stridor. Normal blood pressure.				Y					U	11/08/2005	11/10/2005	2		PVT	PUB	Zantac, milk of magnesia	gastritis				1						1	Urticaria	FLU3~SANOFI PASTEUR~U18708A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247240	11/10/2005	CA	68.0	67		F	11/10/2005	shortness of breath with wheezing and cough lasting approx. 2 hrs followed by fever, chills and slightly rapid heart beat for several hrs.									Y	11/09/2005	11/09/2005	0	none	UNK	UNK	synthroid	none	seasonal allergies thyroid deasese			1						1	Chills; Cough; Dyspnoea; Heart rate increased; Pyrexia; Wheezing	FLU3~PFIZER\WYETH~~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0247241	11/10/2005	CO	35.0	35		F	11/10/2005	Received flu vaccine at 0945; noticed ocular pruritus around 1030 that progressed to pruritus around neck/upper chest and noticed red flushing rash around chest/neck and face. Returned to clinic. Initially given Zyrtec 10mg. Vital signs stable. No other symptoms. After 30 minutes new onset urticaria on face. Given 0.3mg Epinephrine intramuscularly. Symptoms resolved.				Y					Y	11/10/2005	11/10/2005	0	None	MIL	MIL	Zyrtec 10mg po 24 hours earlier. Synthroid 0.125mg in morning.	None	Hx of allergies and asthma			1						1	Flushing; Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U1916AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247242	11/10/2005	CA	0.51	0	.5	F	11/10/2005	Redness at vaccine site R thigh, not warm to the touch.  Redness has decressed since 10/9/05. No treatment needed.  Mother applied warm compresses to reduce redness.									Y	11/07/2005	11/09/2005	2		UNK	UNK	NONE	NONE, WELL CHILD PE VISIT	NONE			1						1	Injection site erythema; Injection site warmth	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A013AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~41765EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0526R~1~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~A594439E~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0247243	11/10/2005	VA	50.0	49		F	11/10/2005	Returned to see RN about 30 minutes after receiving flu shot, c/o throat tightening, tongue thickening & rash around throat.  BP 160/110,HR 80.  Benadryl 50 mgm IM administered, transported via 911 to ER, adrenalin adminsitered by 911.  Pt. stated (after Benadryl given by RN) that she has had a reaction in the past and had taken 25 mgm Benadryl PO at 8:30 AM, which was approximately 45 minutes prior to receiving her shot. She had not told the RN this during the pre-adminsitration screening.  Returned to work at 1415 after treatment in ED (details of treatment unknown - ?solumedrol?)				Y					Y	10/31/2005	10/31/2005	0	Unknown	UNK	UNK	Unknown	Unknown	History of hypertension; other medical history unknown.  Client stated she has had previous reaction to flu shot, and was told by private MD to continue to receive the vaccine but take Benadryl PO before getting it.  Did not tell the nurse this before receiving the vaccine.  Other details of previous reaction unknown.			1						1	Rash; Throat tightness; Tongue disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA141BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0247244	11/10/2005	OH	49.0	49		F	11/10/2005	Difficulty breathing & fast heartbeat x 1day, hoarseness, weakness, dizziness, muscle aches, soreness at shot site, chills x2days (at time of filling out report.)									Y	11/08/2005	11/08/2005	0		UNK	UNK	Nexium, Lexapro, Synthroid, Levsinex, Estratest	None	Heart bypass April 29, 1994	Muscle aches, soreness, sore throat, weakness~Influenza (Seasonal) (Flu-Imune)~1~0.00~In Patient		1						1	Asthenia; Chills; Dizziness; Dysphonia; Dyspnoea; Heart rate increased; Injection site pain; Myalgia	FLU3~PFIZER\WYETH~0~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0247245	11/10/2005	IN	54.0	53		F	11/10/2005	hives started 16 hours after receiving influenza vaccine  Dr. prescribed alternate schedule of Atarax and Benadryl, prednisone(oral & injection)				Y					Y	11/07/2005	11/08/2005	1	None	UNK	UNK			allergic to penicillin			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1752JA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247246	11/10/2005	VA	38.0	38		F	11/10/2005	Approx 36-40 hours after receiving flu shot woke up in middle of night with hives/itching on both arms & legs; began on L arm (where received shot).  Lasted 4 days; treated with Benadryl 25 mgm PO q 3 1/2 - 4 hours during day, 50 mgm at night.  On 2nd day also experienced slightly puffy eyes.  Denies any SOB, wheezing, hives on trunk or head.  Gradually resolved.  Has had hives in the past in response to stress/illness or when really sick, but was not experiencing any of those at this time.  Also had hives several years ago at end of a bout with the flu.  Spoke with PMD on phone, who recommended the Benadryl; was not evaluated in office as condition improved over the next 4 days.									Y	10/28/2005	10/30/2005	2	None	UNK	UNK	unknown	None	Unknown			1						1	Eye swelling; Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU141BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0247247	11/10/2005	IL	55.0	55		F	11/10/2005	I began to have a sharp pain under my right breast at about 1:00 pm 11/03/05 all across my chest and stomach felt sore. My thought was I got cold in my stomach. Then the pain worsened to the point that my breathing was causing the area around my stomach to just ache terrible. I called my family doctor 11/03/05 about 6:00pm I left a voice message. I tried to wait to hear from her but I became more agitated. Finally my daughter 11/04/05 11:00 am called a friend and took me to  the ER. I told the doctor I was having a lot of pain and it hurt to breathe. I also told him I had taken a Flu vaccine 11/01/05. The doctor ordered blood work a ultra sound a chest x ray and an EKG. I ask the doctor to give me something for pain so I could rest. I was given a shot for pain and something for my stomach. I started to feel better and there was no more pain. I stayed in the ER about six hours The doctor discharged me with two prescriptions 1 for Ranitidine 150 mg Ibuprofen 600 mg. I have a appointment to see my primary physician on  November 15 2005 at 3:00 pm.				Y					Y	11/01/2005	11/03/2005	2		UNK	UNK		I was not ill at the time I took the vaccine	Diabetes high cholestrol high blood pressure hepatitis djd			1						1	Abdominal pain; Breast pain; Chest pain; Dyspnoea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0247248	11/10/2005	OR	59.0	59		F	11/10/2005	Patient became immediately nauseated following injection. I had patient sit down and watched them for about 45 seconds. At that time she was having difficulty breathing, not tightness in chest but having a hard time breathing. Began to get clamy, pale, and having a difficult time finding the words to converse. I administered an Epi-Pen into left arm Deltoid at injection site. Called 911, Continued to observe patient until EMS arrived. She remained conscious and talking, symptoms did not worsen. EMS arrived within 4 minutes.				Y					Y	11/09/2005	11/09/2005	0	EMS informed me that she was doing fine they were taking her to ER for further exam, Most of her symptoms at time of departure were related to Epi-Pen	UNK	UNK	lovastatin, DSS, seroquel, acyclovir, protonix, lexapro, HCTZ, Atenolol	None known	HBP, hyperlipidemia, mood disorder, GERD			1						1	Cold sweat; Dyspnoea; Nausea; Pallor; Speech disorder	FLU3~SANOFI PASTEUR~U1818ab~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247249	11/10/2005	NY	47.0	47		M	11/10/2005	MEMBER COMPLAINED OF ITCHY RAISED RASH ON SCALP, BACK, CHEST. STARTED 2 DAYS AFTER VACCINATION. AS OF TODAY IS STILL ITCHY BUT HAS STARTED TO RESOLVE.									N	11/05/2005	11/07/2005	2		MIL	MIL	N/A	N/A	PATIENT HAD SAME RASH OCT 2003 WITH ANTHRAX AND INFLUENZA VACCINE GIVEN SAME DAY. THOUGHT WAS IT WAS THE ANTHRAX SINCE NO PAST ISSUES WITH FLU. PATIENT SEEN FOR CONSULT WITH IMMUNOLOGY/ALLERGY. PATIENT TOOK PICTURES OF RASH.			1						1	Pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~V1911AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247250	11/10/2005	CO	8.0	8		M	11/10/2005	Pt received influenza TIV on 11.6/05 and developed swollen lymph nodes and extreme pain under the arm which received the injection.									Y	11/06/2005	11/06/2005	0		UNK	UNK						1						1	Lymphadenopathy; Pain	FLU3~SANOFI PASTEUR~U1903AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247251	11/10/2005	MI	58.0	57		F	11/10/2005	5:30pm developed weakness, chills, pallor, aluminum taste in mouth, feverish (did not check temp), itchiness on neck(no rash or hives). Went to bed- woke up at 3am diaphoretic, wet feeling. Feeling weak, but better today.									Y	11/09/2005	11/09/2005	0		UNK	UNK	oxycontin 80mg twice daily, wellbutrin daily, carafate three times daily as needed	hepatitis C	PCN, codeine			1						1	Asthenia; Chills; Dysgeusia; Hyperhidrosis; Pallor; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~U1912AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0086R~1~IM~RA~HEP A (VAQTA)~1	USA		Influenza
0247253	11/10/2005	VA	23.0	22		F	11/10/2005	Approx 25 minutes after receiving flu vaccine c/o feeling shaky, hands shaking; no hives, itching or SOB at that time.  Approx 5 minutes later developed several red spots on face, but still no SOB or wheezing.  Figen Benadryl 50 mgm IM in same arm as shot.  Transported via 911 to ER.  Pt. stated she felt worse after the Benadryl.  BS 122/72, HR 120, Resp 16 as Benadryl given; EMS personnel reported systolic BP at 150 when they arrived.  Follow-up with ER - received solumedrol IV, discharged at 2:00 PM.				Y					Y	10/16/2005	10/16/2005	0	Unknown	UNK	UNK	Unknown	None	Unknown			1						1	Blood pressure increased; Erythema; Tremor	FLU3~SANOFI PASTEUR~U1778AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247255	11/10/2005	TX	29.0	29		F	11/09/2005	Approximately 30 minutes after vaccination developed numbness on tongue and some difficulty swallowing.  Per recommendation of physician and client was given oral Benadryl 50mg, and observed for 1 hour. Symptoms resolved.  On 11/04/2005 spoke with the client and she related she had a headache that PM but this resolved as well.									Y	11/02/2005	11/02/2005	0	None	UNK	UNK	None	Cold.  No fever.	None Known			1						1	Dysphagia; Headache; Hypoaesthesia oral	FLU3~SANOFI PASTEUR~U1811AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247256	11/11/2005		6.0	6		F		A report was received from a healthcare professional in the US on 11/1/05, concerning a 6 year old female vaccinee. No details were provided regarding the vaccinee's concomitant medications. The vaccinee was already hospitalized for other reasons that were not reported. On 10/28/05, the vaccinee received Fluvirin (batch 61122), IM. On 10/30/05, the vaccinee began to experience 6 movement disorder. She was evaluated by a neurologist and the symptoms were not classified as tics but as polymyoclonia. Follow up information will be sought. (OMIC)										10/28/2005	10/30/2005	2		UNK	UNK	Concomitant drugs not reported.				CVOX200500143	1						1	Movement disorder; Myoclonus	FLU3~EVANS VACCINES~61122~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0247258	11/11/2005	GA	0.76	0	.8	F	11/10/2005	Erythema multiforme- minor causes to target lesion over the face, torso, extremities but no mucosal involvement. Patient was interactive and appropriate during exam. Information from Follow-up report states: Dr called Pediatric Partners and stated that patient received a flu vaccine on November 8,2005 and had an adverse reaction to the vaccination. She was seen and treated in the office by DR and he is now requesting the lot number, expiration date, manufactuer of vaccine, and route of the influenza vaccine.				Y					U	11/08/2005	11/09/2005	1	NONE	PVT	PVT	NONE	none- 9 month well child visit	NONE			1						1	Erythema multiforme; Skin ulcer	FLU3~SANOFI PASTEUR~U1743HA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247259	11/11/2005	TX	56.0	56		F	11/11/2005	Body aches experienced on day of immunizations. Injection site swelled and continued swelling until entire upper arm was swollen on 10/07/2005. Patient was advised to take 50mg of benadryl and follow up with doctor.									Y	10/04/2005	10/04/2005	0	n/a	UNK	UNK	n/a	n/a				1						1	Injection site swelling; Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~U1806AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247260	11/11/2005	TX	52.0	52		F	11/11/2005	Having Flu Symptoms for 2 days									Y	11/07/2005	11/08/2005	1		UNK	UNK						1						1	Influenza like illness	FLU3~SANOFI PASTEUR~U1903AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247261	11/11/2005	TX	63.0	63		M	11/11/2005	Having flu symptoms for 2 days									Y	11/07/2005	11/08/2005	1		UNK	UNK						1						1	Influenza like illness	FLU3~SANOFI PASTEUR~U1903AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247262	11/11/2005	CA	70.0	70		F	11/11/2005	24 hrs after flu shot, dizzy, severe aches in joints especially one knee, fever and cold chills then hives, starting on back then neck, arm, eye lids and ankle.  Have had flue shots for years with NO adverse effects.  I am in good health, no major problems except Macular Degeneration of one eye and minor back pain. The reaction lasted approx 24 hrs. I did not call the Doctor nor go to the ER.									Y	11/07/2005	11/08/2005	1		UNK	UNK		None				1						1	Arthralgia; Chills; Dizziness; Pyrexia; Urticaria	FLU3~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0247272	11/11/2005	MI	49.0	49		M	11/11/2005	SOB,cough, Chest pain, body ache, R shoulder ache  comes in today first time since reaction 11am  11-11-05				Y					U	11/08/2005	11/09/2005	1	chest xray negative  pulse ox 98%	UNK	UNK	ultram, lunesta, xanax	copd, metastatic lung cancer s/p right thoracotomy/lobectomy	EES			1						1	Chest pain; Cough; Dyspnoea; Pain	FLU3~SANOFI PASTEUR~u1810AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247274	11/11/2005	MD	38.0	37		F	11/11/2005	2 dyas after the injection developed redness and pain at injection site of Tdap (Adacel)				Y					Y	11/08/2005	11/10/2005	2		UNK	UNK		none	Diabetes, pulmonary stenosis			1						1	Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~u1912aa~1~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~c341aa~1~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0247276	11/11/2005	TX	60.0	60		F	11/11/2005	Shortness of breath, bloodshot eyes, tingling lips, abnormal EKG				Y					Y	11/10/2005	11/10/2005	0	EKG, CMP, CBC	UNK	UNK	Lipitor 10 mg hs Diazide 37.5/25mg daily Premarin .45 mg daily Advair 250/50 mg bid Nexium 40 mg daily Nasocort prn Patanol 0.1 1 drop hs		Hypertension Hypercholesterolemia Asthma Menopausal Palpitations			1						1	Dyspnoea; Electrocardiogram abnormal; Ocular hyperaemia; Paraesthesia	FLU3~SANOFI PASTEUR~U1913AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247277	11/11/2005	AZ	62.0	62		F	11/11/2005	8 hrs after flu vaccine administered, I had high fever, chills and aches everywhere.  I have had the flu in years past and I can only describe this has having a severe case of the flu for 8 hours.  This is the 2nd year I have taken the county vaccine and had this reaction.  I can only conclude that serum from some manufacturers does not agree with me.									Y	11/04/2005	11/04/2005	0		UNK	UNK	estrace, vitamins, lortadine, atenolol	None.  No other vaccine given within 4 weeks prior to date listed in #10.  (Can't clear this entry - it's a typo)	None			1						1	Chills; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247278	11/11/2005	ND	87.0	86		F	11/11/2005	11-4-05 C/o pain rt side rt lower lobe crackles 11-5-05 rt rib pain in morning. 5pm clammy unresponsive went to ER died at hospital. Hospital reports died from pulmonary embolism. Have not received death certificate at this time. 11/18/05 Death certificate received which revealed COD as pulmonary emboli.	Y	11/05/2005							N	11/02/2005	11/04/2005	2		UNK	UNK		had UTI diagnosed 11-1-05	Bactrim Augmentin Flagyl			1						1	Cold sweat; Coma; Pain; Pulmonary embolism	FLU3~EVANS VACCINES~61503~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0247279	11/11/2005	MI	30.0	29		M	11/11/2005	Generalized vaso-vagal response, given orange juice, returned to work.  Approximately 45 minutes after injection, employee returned with c/o persistent dry cough and developing scratchy throat with puffiness tearing and itching of eyes.				Y					Y	11/10/2005	11/10/2005	0		UNK	UNK			Self reported HX of Von WillenBrands			1						1	Cough; Eye irritation; Eye swelling; Lacrimation increased; Pharyngolaryngeal pain; Syncope vasovagal	FLU3~SANOFI PASTEUR~U1846AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247280	11/11/2005	ND	95.0	95		F	11/11/2005	11-03-05 moist mouth breathing no verbal response. Flaccid rt arm. Bilateral rhonchi yellow phlegm. 11-04-05 Verbally responding in the am Drank water. Expired 11-05-05 at 11pm. Death certificate states respiratory failure and pneumonia as cause of death.	Y	11/05/2005							N	11/02/2005	11/03/2005	1		UNK	UNK		No	ASA Phenergan			1						1	Hypotonia; Pneumonia; Respiratory failure	FLU3~EVANS VACCINES~61503~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0247282	11/11/2005	CA	45.0	44		M	11/11/2005	Fever, malaise, muscle aches, 12-24 hrs. after shot.									U	11/08/2005	11/08/2005	0		UNK	UNK		None	Not Known			1						1	Malaise; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~u1848AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0790p~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247283	11/11/2005	CO	40.0	39		F	11/11/2005	Arm soreness - more than typical, low-grade fever onset 10/8/05 temperature ranging from 99.4 to 101.6. Swelling and rash appeared on 11/10/05 covering inside portion of left arm, below injection site and around the arm. Swelling dissipated overnight, but rash remains. Began 3 ibuprofen every 6 hours on 11/10/05.									Y	11/07/2005	11/08/2005	1	none	UNK	UNK	EffexorXR 75mg, Sudafed 12 hour, Levora, calcium supplement, garlic supplement, one-a-day women's supplement, albuterol inhaler	none other than stress and tiredness	Severe-to-profound bilateral sensorineural hearing loss, severe seasonal allergies, asthma, recurrent bronchitis			1						1	Injection site rash; Injection site swelling; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA120BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0604R~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247284	11/11/2005	NE	61.0	61		F	11/11/2005	Red hot arm treated with depomedrol and over the counter benadryl.				Y					Y	10/24/2005	10/25/2005	1		UNK	UNK	none	none	none listed			1						1	Erythema; Feeling hot	FLU3~SANOFI PASTEUR~U1828AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0055R~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247285	11/11/2005	GA	49.0	48		F	11/11/2005	Had severe body aches and stiffness. Also was light headed and had vomiting.									Y	11/09/2005	11/10/2005	1		UNK	UNK		none	asthma			1						1	Dizziness; Musculoskeletal stiffness; Pain; Vomiting	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247286	11/11/2005	VA	67.0	67		F	11/11/2005	pt said her arm was getting redder, more swollen and warm, she had not taken anything for the arm or contacted anyone regarding symptoms.  she came to the pharmacy 24 hours latter, I gave her Benadryl and sent her to her pcp, no difficulty  breathing reported.										10/10/2005	10/10/2005	0	have been trying to contact pt since oct 11.	UNK	UNK						1						1	Erythema; Feeling hot; Swelling	FLU3~SANOFI PASTEUR~u1788aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~o749~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247287	11/11/2005	CA	11.0	11		F	11/11/2005	Unilateral (right) facial nerve palsy beginning hours following vaccine administration. Now improving, but not yet fully recovered. Information from medical records states twitch, facial paralysis. msv				Y					U	11/02/2005	11/02/2005	0	None	UNK	UNK		none	N/A Medical records state obesity. msv			1						1	Facial palsy; Muscle twitching; Paralysis	FLU3~SANOFI PASTEUR~1832BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U1576AA~1~IM~UN~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0247303	11/11/2005	GA	0.76	0	.8	M	11/04/2005	Seriousness criteria other medically significant (OMIC). Initial report received from a physician on Oct 31 2005. A nine month old male infant developed extensive purpura on lower extremities and some on the face and ears three days after receiving the first injection of Fluzone, lot number U1743JA in the left thigh on Oct 25 2005. The patient has a history of eczema and is on topical steroid betamethasone. At the time of vaccination the patient had slight diarrhea. As per reporting physician the purpura resembles HSP Henoch Schonlein Purpura. The physician reports the mom stated the child had a low grade fever and has been fussy. At the time of this report the patient had not recovered. Follow-up information received on 15/Nov/2005 from a health care professional. It was reported that the FLUZONE was administered intra-muscularly. No investigations were completed for the diarrhea the patient had at the time of vaccination and the event resolved. The diagnosis of Henoch-Schonlein Purpura was not confirmed as per the reporter. The patient did not receive a subsequent dose of FLUZONE. The patient was seen by the physician on 11/Nov/2005 and was improved at that time. He has not been seen since and his recovery status is unknown. Follow-up information received on 16/Jan/2006 from a health care professional. Per the reporter, there have been no changes or further evaluation since 15/Nov/2005. The patient is well and has recovered.				Y					Y	10/25/2005	10/28/2005	3		UNK	UNK	Betamethasone	At the time of vaccination the patient had slight diarrhea.	The patient has a history of eczema and is on topical steroid Betamethasone. At the time of vaccination the patient had slight diarrhea. The patient did not receive any vaccinations within four weeks prior to receiving Fluzone. No reported adverse events with any prior vaccinations.		200502247	1						1	Henoch-Schonlein purpura; Irritability; Purpura; Pyrexia	FLU3~SANOFI PASTEUR~U1743JA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247307	11/11/2005	OH	51.0			F	11/07/2005	Initial report received from a registered nurse on Sept 28 2005, A 51 year old female patient developed a cough, fever and wheezing latency not reported which required hospitalization after receiving the injection of Adacel, lot number C2151AC and Fluzone, lot number U1854AA in the deltoid. Administration date, route and site not reported.  The patient has no known allergies and has a history of heart condition type unknown. She denies any illness at the time of vaccination and was on other medications, however the specific Meds are not known. It was reported that the patient was in the hospital for a week. Dates of hospitalization and treatment received not reported. As per reporter the patient was still hospitalized at the time of this report.					Y	0			N					PVT	PVT	On other medications however the specific meds are not known.		The patient has no known allergies and has a history of heart conditions type unknown. She denied any illness at the time of vaccination and was on other medications, however the specific Meds are not known.		200502237	1						1	Cough; Pyrexia; Wheezing	FLU3~SANOFI PASTEUR~U1854AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2151AC~UNK~~UN~TDAP (ADACEL)~1	USA	Hospitalisation	Influenza
0247308	11/11/2005	CA	35.0	35		F	11/07/2005	Initial report received on Nov 01 2005 from a health care professional. A female patient with no reported age and denies allergy to eggs felt hot and itchy in the right side, had nausea, dizziness, shortness of breath, media sternal chest pressure, right arm numbness, hypertension at 152/105, swelling of face and tongue at an unspecified time, the day she received the influenza vaccine (Fluzone SV 2005-2006) lot # U1754AA in the right deltoid on Oct 20 2005. She had received Ativan, Magnesium sulfate, Lopressor, H1 and H2 blockers, Benadryl and epinephrine during unspecified time frame. She was admitted and discharged from an ER at an unspecified time. The outcome was not reported at the time of the report. Of note that the reporter was not sure whether the patient received the influenza vaccine but she was receiving yearly vaccinations for the past five years. According to the reporter the above mentioned symptoms of the adverse events were not consistent with influenza vaccine specially the hypertension. Additional information received from a health care provider on Nov 7 2005. Per the reporter, the vaccine administrator confirmed that Fluzone was administered, and the facility was able to provide the lot number. Per the reporter, the patient had recovered.				Y					Y	10/20/2005	10/20/2005	0		UNK	UNK					200502276	1						1	Chest pain; Dizziness; Dyspnoea; Face oedema; Feeling hot; Hypertension; Hypoaesthesia; Nausea; Pruritus; Tongue oedema	FLU3~SANOFI PASTEUR~U1754AA~6~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247309	11/11/2005	PA	17.0	17		F	11/04/2005	Initial report received on Nov 1 2005 from a health care professional. A 17 year old female patient with a medical history of chronic pain, reflex sympathetic dystrophy and seasonal allergies developed paralysis in right arm Sept 22 2005, I.E. the day after the intramuscular influenza vaccine (Fluzone SV 2005-2006) lot # U1772AA, administration. The patient had the ongoing reflex sympathetic dystrophy at the time of the vaccination. On Oct 4 2005, had an MRI for the persistent paralysis. On Oct 21 2005, the consulting neurologist diagnosed the Parsonage turner syndrome. It was reported that, on Oct 27 2005, she was hospitalized due to total body paralysis from the neck to downwards but had some movements. The patient was not recovered at the time of this report.					Y	0			N	09/21/2005	10/27/2005	36		PVT	UNK	Neurotinin, Allegra, Elavil, Nasacort		Chronic pain, reflex sympathetic dystrophy and seasonal allergies.		200502279	1						1	Neuralgia; Neuritis; Neuropathy; Pain; Paralysis; Radiculitis brachial	FLU3~SANOFI PASTEUR~U2883AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0247310	11/11/2005	NJ				U	11/08/2005	Initial report received from another company on 11/2/2005. It was initially reported by a physician that a health care professional (no individual patient identification provided) received a dose of influenza vaccine in the deltoid on an unspecified date. The lot numbers was not reported, but the manufacturer was reported. An unspecified amount of time later, the patient experienced an anaphylactic reaction. No other information was provided. The reporter of this case is the same as for non serious case 200502307.				Y					U					UNK	UNK					200502305	1						1	Anaphylactic reaction	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247311	11/11/2005	MI				F	11/08/2005	Seriousness criteria other medically significant (OMIC). Initial report received on Nov 3 2005 from a health care professional. A female geriatric patient had received an (route and site not reported) administration of Fluzone SV 2005-2006 usp, lot number and date of vaccination not reported. At an unspecified time later, the patient developed a whole body chicken pox like rash that was macular papular in appearance with some clear fluid filled vesicles. She was admitted to the hospital (date not reported) from an emergency care facility and was treated by an infectious disease physician. Biopsy of the vesicles were completed and the results were pending at the time of this report.				Y	Y	0			N					OTH	UNK					200502338	1						1	Blister; Dermatitis bullous; Rash maculo-papular	FLU3~SANOFI PASTEUR~UNK~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0247313	11/11/2005	FL	34.0	33		F	11/11/2005	Ten minutes following administration of vaccine, pt c/o warmth over her body, then hives, then immediate respiratory distress and throat closing. 911 called, and she was given stat Epi pen 0.3 mg subq with relief. She was transported to the ER and observed until stable.			Y	Y					Y	11/07/2005	11/07/2005	0		OTH	OTH	Advair; Albuterol; Gabapenten		Asthma			1						1	Feeling hot; Respiratory distress; Throat tightness; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA151AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Life Threatening	Influenza
0247327	11/11/2005	MO	4.0	3		F	11/11/2005	Flu shot given on 11/4/05 went to ER on 11/5/05 had broke out in hives on trunk and legs over night; no distress- hives fading due to any intervention.				Y					Y	11/04/2005	11/05/2005	1		PVT	PVT	Prednisone, Methotrexate	Juvenile Dermatomyositis	none, Duodenal atresia at birth- repaired			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1761AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247451	11/11/2005	KY	83.0	82		F	11/11/2005	Felt weak, thirsty, must have been running fever. Drank a lot of liquids and crawled in bed; too weak to take temperature. Also had breathing problems, heart racing, headache. Did not take any medication. Was OK by next day.									Y	11/04/2005	11/06/2005	2		UNK	UNK	Prevacid, Actonel with 6 Diovan. Multivitamin		Glaucoma, high blood pressure, acid reflux, osteoporosis, phlebitis, Fibromyalgia			1						1	Asthenia; Dehydration; Dyspnoea; Headache; Heart rate increased; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247452	11/11/2005	AK	0.65	0	.7	M	11/11/2005	Mother noticed flat rash on trunk of body salmon in color, non papular, non-macular. Temperature of 101 degrees today.										11/08/2005	11/08/2005	0		PUB	PUB	Cipro, Zithromax	Ear Infection				1						1	Pyrexia; Rash	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B010AA~2~~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1743IA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0186R~2~~LL~HIB (PEDVAXHIB)~1	USA		Influenza
0247289	11/12/2005	WI	65.0	65		F	11/12/2005	SORENESS IN ARM WITHIN 3 HOURS. HIVES AND HOT TO TOUCH BETWEEN ELBOW AND SHOULDER. HURT TO LIFT ARM ABOVE SHOULDER OR LAY ON ARM. FELT TIRED ALL OVER.									U	11/10/2005	11/10/2005	0		UNK	UNK	TIMOLOL	NONE	SULFA ALLERGY - GLAUCOMA			1						1	Fatigue; Injection site warmth; Pain; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247290	11/12/2005	TN	33.0	32		M	11/01/2005	Influenza vaccine administered in right deltoid at 13:30. Patient stated that he felt as though the room was closing in and then everything went black. Patient fell to the floor and blacked out for a split second.  Patient's color had drained out of him and he was diaphoretic. Patient was awake, alert and talking. Given a piece of candy. Color returned to normal. Patient given a lollipop and water and layed on the floor for 15-20 minutes. Then sat in chair for 5 minutes. Made complete recovery.									Y	11/01/2005	11/01/2005	0		UNK	UNK						1						1	Hyperhidrosis; Loss of consciousness; Pallor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA1488A~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0247291	11/12/2005	WA	66.0	66		M	11/12/2005	Headache, pain behind the eyes, slight fever, local pain at site of injection, mild diarrhea next morning.  Better by next morning but still not 100%  Treatment:  2 Advil									Y	11/11/2005	11/11/2005	0	none	UNK	UNK	lipitor 20 mg per day	none	none			1						1	Diarrhoea; Eye pain; Headache; Injection site pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247292	11/12/2005	MD	31.0	31		F	11/12/2005	High temperature (39 oC, 102F) for 2 days after 1 day from the flu shot. Muscle and joint ache at whole body for 2 days after 1 day from the flu shot. Nausea and diarrhea for 3 days after 1 day from the flu shot. No appetite for 3 days after 1 day from the flu shot. I had slept for two days and cured.  I just want to report my case. These symptoms were so severe. I couldn't move and therefore couldn't go to a hospital.									Y	11/08/2005	11/09/2005	1		UNK	UNK		None	None			1						1	Anorexia; Arthralgia; Diarrhoea; Myalgia; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247294	11/12/2005	AZ	35.0	34		M	11/12/2005	TEN MINUTES AFTER RECEIVING VACCINE PATIENT COMPLAINED OF A TINGLING AND NUMB TONGUE. STATED IT WAS HARD TO FORM WORDS. HE ALSO STATED HIS THROAT WAS GETTING HOARSE AND BEGIN CLEARING HIS THROAT ALL THE TIME. ALSO   COMPLAINED OF SLIGHT TIGHTNESS OF THE CHEST AND THAT IT WAS HARD TO GET A FULL BREATH.  PATIENT STATED THAT  THE SYMPTOMS HE WAS  EXPERIENCING WERE THE SAME AS THOSE HE EXPIRENCED IN A PAST ANAPHYLACTIC REACTION.   PATIENT WAS PROMPTLY ADMINISTERED 0.3MG OF EPINEPHRINE VIA EPIPEN. FIRE/ RESCUE ARRIVED 5 MINUTES LATER. PATIENT REFUSED TRANSPORT TO HOSPITAL BUT INSTEAD WENT TO URGENT  CARE WITH WIFE. PER PATIENT HE  WAS GIVEN A STEROID INJECTION AND A SCRIPT FOR METHYLPREDNISOLONE  AT URGENT CARE. SPOKE TO PATIENT VIA PHONE 7 HOURS LATER AND STATED HE WAS DOING FINE.				Y					Y	11/12/2005	11/12/2005	0		UNK	UNK		NONE	ALLERGIES  TO MACROLIDES, CODEINE, LIDOCAINE, AND VARIOUS FOODS INCLUDING CORN.   REPORTS NO PREVIOUS ALLERGY TO VACCINES			1						1	Chest discomfort; Dysphonia; Hypoaesthesia; Paraesthesia; Speech disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA144AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0247295	11/12/2005	MD	48.0	48		F	11/12/2005	About 3-4 hrs. after the shot, I had a feeling like my throat was closing up.  I could breathe ok, but felt when I swallowed that there were 2 boulders in my throat.  I also started coughing, like there was a tickle in my throat. My throat was not sore. One other symptom was that my eyes were both red and had yellow puss in the corners.  Within the next hour, I went to be examined and treated.  The doctor prescribed Hydroxyzine- 25 mg and also 150 mg zantac.  I took both and within the next hour felt totally better.  The closing of the throat and the cough went away.  And my eyes cleared up. I slept fine.  Today I woke up with a headache which was helped by Tylenol.  All day I felt lethargic and slept but no other symptoms.  Did not need to take any further medication.				Y					Y	11/11/2005	11/11/2005	0	none/ just examined  - Pulse oxygen was 99%, temperature was normal.	UNK	UNK	on zoloft 150 mg/day calcium and multivitamin	none	allergic to Talwin, Demerol, Sulfa drugs Have had hypo-thyroid and hyper-thyroid, but currently am stable and on no medication for this.			1						1	Cough; Dysphagia; Eye discharge; Headache; Lethargy; Ocular hyperaemia; Throat tightness; Pharyngeal oedema; Eye swelling; Pharyngeal oedema	FLUX~UNKNOWN MANUFACTURER~~3~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1863AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~U1863AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Emergency room visit	Influenza
0247297	11/13/2005	TX	44.0	44		F	11/13/2005	FEVER AND SEVERE BODY ACHES				Y					U	11/07/2005	11/09/2005	2		UNK	UNK		none	none			1						1	Pain; Pyrexia	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0247298	11/13/2005	TX	39.0	38		M	11/13/2005	Temperature of 102 for two consecutive days. Soreness and swelling in throat.  Body aches including muscles and head.										11/10/2005	11/11/2005	1		UNK	UNK						1						1	Headache; Myalgia; Pharyngeal oedema; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U1817AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247300	11/13/2005	TX	70.0	69		F	11/13/2005	Patient had flu shot 11/08/05. Now has 48mm swelling, erythema, and pain at injection site(left arm).  Left arm has red, firm, slightly raised 10x7 cm area on upper arm. Treated with Levaquin 500mg daily for 5 days.  Zyrtec 10mg daily for 5 days. Predisone 40mg one dose.										11/08/2005	11/11/2005	3		UNK	UNK			lupus - not treated at this time.			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~u1866aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247301	11/13/2005	MI	55.0	55		F	11/13/2005	Received flu shot at 3:00PM on 11/11/05 and by 7:00PM started to have asthma symptoms and had to use albuterol spray.  Eyes then became very swollen (nearly shut) and crusty.  Then got chills and very rapid heart beat										11/11/2005	11/11/2005	0		UNK	UNK	Asthmacort, flonase		Asthma			1						1	Asthma; Chills; Condition aggravated; Eye discharge; Eye swelling; Heart rate increased	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0247302	11/13/2005	UT	47.0	47		F	11/13/2005	Hives around location vaccine given within 24 hour period. Lasted 48 hours.									Y	11/10/2005	11/11/2005	1		UNK	UNK	None	None	Arthritis			1						1	Urticaria	FLU3~PFIZER\WYETH~~5~IM~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|PPV~PFIZER\WYETH~~1~IM~RA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0246450	11/14/2005	GA	9.0	9		M	10/31/2005	A nurse reported that a 9 year old male experienced diaphoresis, pallor, headache and weakness, 5 minutes after receiving FluMist vaccine on Oct 29 2005. The patient remained oriented during this time. Oxygen was administered and after 15 minutes, the patients color has resumed and was ambulating well. The patient recovered from the adverse events. The reporter assessed the events as possibly related to FluMist. Additional information has been requested. Follow up - A nurse reported that a 9 year old male experinced diaphoresis, pallor, headache and weakness, 5 minutes after receiving FLUMIST vaccine on 29Oct05. The patient was assessed by a nurse practitioner, who consulted with one of their physicians over the phone regarding the event. Blood pressure was 100/60 mmHg and pulse rate was within normal limit. The patient remained oriented during this time. Oxygen was administered at 2.5-3.0 liters and after 15 minutes, the patient's color resumed and was ambulating well. The patient completely recovered from the adverse events. The following day, the patient's mother reported that the patient is doing fine and did not have any complaints. Per the reporter, the patient does not have any past medical history and was not known to be allergic to egg or egg products. The reported assessed the events as possibly related to FLUMIST. 13Nov05 Follow up information obtained and incorporated in the narrative: vital signs, account of O2 administered, confirmed that pt recovered and does not have any past medical history and allergies.									Y	10/29/2005	10/29/2005	0	Blood pressure, 10/29/05, 100/60 mmHg	PVT	PVT	Concomitant (s) Drug (s) Not Reported				MEDI0003796	1						2	Asthenia; Headache; Hyperhidrosis; Asthenia; Headache; Hyperhidrosis; Hypoxia; Pallor	FLUN3~MEDIMMUNE VACCINES, INC.~500392P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500392P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0246564	11/14/2005	TN	49.0	49		F	11/01/2005	Pt states received vaccine around 12:45pm 10/27/05 approximately 15 minutes later she reports feeling like her throat was swelling with difficulty breathing. About 3-4 hrs later she reports feeling like she had water on her lungs swelling of the face , red and itchy eyes and coughing that sounded like a dog's bark.  That night she states fever 99.9F achiness and chills that continued into the next day. States she took one dose of 500mg acetaminophen 12.5mg diphenhydramine,20mg, ?? the 2nd day.									Y	10/27/2005	10/27/2005	0	NONE	PUB	UNK	NONE	NONE	Allergy to sulfur and Compazine		TN05052	1						2	Chills; Cough; Eye discharge; Eye inflammation; Eye swelling; Feeling cold; Headache; Malaise; Nausea; Pain; Pharyngeal oedema; Pyrexia; Wheezing; Cough; Dyspnoea; Face oedema; Ocular hyperaemia; Pain; Pharyngeal oedema; Pruritus; Pulmonary congestion; Pyrexia	FLU3~SANOFI PASTEUR~u1838aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1838AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0246812	11/14/2005	MO	40.0	40		F	11/10/2005	Initial report received on 04/Nov/2005 from the patient, a 40-year-old female patient received an intra-muscular injection of Fluzone SV 2005-2006 USP, lot number U1761AA in the left arm on 05/Oct/2005 at 08:15. At 19:00 on 07/Oct/2005 she developed pain near her left eye and vision blurring. She was seen by her primary care physician on 10/Oct/2005 with symptoms of left retro-orbital headache extending to the sinus and left side of the head. She was diagnosed with migraine headache related to stressful family situation and amenorrhea times two months. She was started on Relpax for her migraine headache. She had a Papanicolsou smear and complete blood count that day and the results are pending. On 12/Oct/2005 she was seen by an optometrist who performed a visual field exam and noted a defect in the vision field of the left eye and diagnosed her with left optic neuritis. He ordere3d a computed tomography scan of the head (with an without contrast) to rule out multiple sclerosis and referred her to a neurologist. Th computed tomography scan was completed on 12/Oct/2005 and was unremarkable. On 20/Oct/2005 the patient was seen by a neurologist who diagnosed her with left optic neuritis without other associated symptoms related to multiple sclerosis versus isolated optic neuritis. he wanted to treat the patient with intravenous steroids the following Monday and ordered a magnetic resonance imaging of the brain, orbit and cervical spine. The magnetic resonance imaging was completed on 25/Oct/2005 and was diagnosed with very mild optic neuritis of the left eye versus one of the other conditions that can be associated with visual field loss. These include multiple evanescent white dot syndrome, the Acute Idiopathic enlargement of the blind spot syndrome or more unlikely, one of the atypical retinopathies. She is to follow-up with the retinal specialists.				Y					N	10/05/2005	10/07/2005	2	The patient had a physical exam on 10/10/05 and CBC and Pap Smear were performed. The results are pending. A computed tomography was completed on 10/12/05 and result was unremarkable. An eye exam was performed on the patient on 10/12/05 and she was diagnosed with optic neuritis of the left eye. A visual field test that showed a defect in the left vision field. The patient had an extensive eye exam with a retinal specialist on 10/20/05 and was diagnosed with left optic neuritis. She had a neurology consult on 10/25/05 and the result was unremarkable.	PVT	PVT					200502354	1						2	Eye pain; Migraine; Optic neuritis; Vision blurred; Visual field defect; Eye pain; Headache; Migraine; Nausea; Optic neuritis; Vision blurred; Visual field defect	FLU3~SANOFI PASTEUR~U1761AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1761AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0247316	11/14/2005	GU	54.0	54		F	11/14/2005	Patient claims felt pain in left arm that evening. Pain comes and goes, she cannot lift arm or move side to side. Pain radiates to fingers and to neck. No fever. Saw M.D. 11/10/05 received a shot and Meds (propoxyphene 50mg) claims pain still bothering her.				Y					N	11/05/2005	11/05/2005	0		OTH	UNK			Allergic to Tylenol			1						1	Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U1824AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~MASS. PUB HLTH BIOL LAB~Td109~2~IM~LA~TD ADSORBED (TDVAX)~1	USA	Emergency room visit	Influenza
0247317	11/14/2005	WA	85.0	84		F	11/13/2005	Fever (low-grade) sore throat, weakness in legs, dizziness. Symptoms beginning within hours of vaccine. Taken to ER and treated fever- dx- unknown sent home. 11/13 feeling better today.				Y					Y	11/08/2005	11/08/2005	0		OTH	OTH						1						1	Asthenia; Dizziness; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U1818AB~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247318	11/14/2005	CA	47.0	47		F	11/12/2005	Patient complaining of light headed, dizziness and flushing within minutes of receiving flu vaccine. No rash noted. Patient blood pressure was normal and pulse was normal. Also had slight nausea, episode lasted 15 minutes.									Y	11/09/2005	11/09/2005	0		OTH	PVT						1						1	Dizziness; Flushing; Nausea	FLU3~SANOFI PASTEUR~U1805AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247320	11/14/2005	GA	68.0	67		F	11/19/2005	Patient reports a dark circle approximately 1 inch in diameter at the site of the injection in 7 days.									N	10/31/2005	11/01/2005	1		OTH	OTH						1						1	Skin discolouration	FLU3~SANOFI PASTEUR~U1826AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247321	11/14/2005	TX	70.0	70		F	11/11/2005	Redness in the face Difficulty Breathing Shaky				Y					U	11/10/2005	11/10/2005	0		OTH	UNK						1						1	Dyspnoea; Erythema; Tremor	FLU3~SANOFI PASTEUR~U1929AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247322	11/14/2005	CA	48.0	47		F	11/11/2005	Left deltoid- red- local swelling reaction at site including redness to left elbow.									Y	11/08/2005	11/09/2005	1		PVT	UNK						1						1	Injection site erythema; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA138AA~6~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0247323	11/14/2005	NJ	60.0	60		F	11/11/2005	Time of injection1:05 pm, pt then had lunch (pizza), began with palpitations in chest, feels short of breath 5X began 1:20pm. Patient felt much improved by 2:15									Y	11/11/2005	11/11/2005	0	EKG Normal	PVT	OTH	Lisinopril, HCTZ, Zocor, Allegra, oxytrol	NONE	Avelox allergy, HTN, hypercholesterol			1						1	Dyspnoea; Palpitations	FLU3~SANOFI PASTEUR~U1833BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247324	11/14/2005	MI	64.0	63		M	11/11/2005	Patient developed fevers of 102 and a large reddened and swelled area on left upper arm at area of injection, TX with Keflex 500mg teaspoons TID X 10 days.				Y					U	11/09/2005	11/10/2005	1		PVT	PVT	ASA-325mg; Tenormin- 25mg; Lipitor- 40mg; Hytrin- 10 mg		CAD, dyslipidemia, HTN, allergic Rhinitis			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U1869AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0967P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247325	11/14/2005	AR	6.0	6		M	11/11/2005	Warmth and Erythema and Edema at injection site.				Y					Y	11/09/2005	11/09/2005	0		PVT	PVT		Cough- no fever				1						1	Feeling hot; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1849AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1046P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247326	11/14/2005	OR	35.0	34		F	11/11/2005	Approximately 30 seconds after giving injection- patient became pale and diaphoretic with high response. I encouraged to sit down lower her back slowly breathing. Approximately 10 seconds later she flared her head up and her body started  to jerk hands contracted inwardly to her body and eyes rolled back. I rushed out to call 911 and office staff promptly called. After body ceased convulsing checked pulse- strong at reg 88. She would not respond to voice commands until I applied pressure to upper arm.  Continued to feel dizzy upon standing up.									N	11/10/2005	11/10/2005	0	911 Arrived; EMT wanted to transport patient to ER because she continued to feel dizzy, almost 2 hours after incident patient declined- felt better; stated would go to ER with significant other if needed.	OTH	PVT	Vitamins	Denied	Stated allergy to Lidocaine			1						1	Convulsion; Dizziness; Dyskinesia; Eye movement disorder; Hyperhidrosis; Pallor	FLU3~SANOFI PASTEUR~U1865AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247355	11/14/2005	CA	51.0	51		F	11/09/2005	A 51 year old female pt, with no significant pre-existing medical conditions, received an IM injection of Fluzone, lot number U1826AA, in the left deltoid on 02/Nov/2005. Later that evening, she developed numbness in the left side of her face and left top part of her head. No treatment was recommended. (OMIC)				Y					U	11/02/2005	11/02/2005	0		UNK	UNK					200502353	1						1	Hypoaesthesia	FLU3~SANOFI PASTEUR~U1826AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247356	11/14/2005	IN	52.0	52		F	11/08/2005	Initial report received from a HCP on 03/Nov/2005. A 52 year old female pt with a medical history of hypertension and an allergy to strawberries received an IM left arm injection of 5.0 ml (not the recommended dose) of Fluzone SV 2005-2006, lot number U1761AA, on 03/Nov/2005 at 11:20 AM. One hour and twenty-five minutes later, the pt developed shortness of breath and felt dizzy. The pt was treated with Benadryl 50 mg per os and administered an epinephrine pen. The pt was transported via ambulance to an ER. The pt had received an unspecified number of previous doses of Fluzone, but adverse events following prior vaccinations were not reported. Illness at the time of vaccination was reported as non, and current medications were unknown. At the time of this report, the pt's recovery status was not reported. (OMIC)				Y					U	11/03/2005	11/03/2005	0		UNK	UNK			The pt has a history of hypertension and an allergy to strawberries.  Other medications were not known. There was no illness at the time of vaccination.		200502340	1						1	Dizziness; Dyspnoea; Medication error	FLU3~SANOFI PASTEUR~U1761AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247362	11/14/2005	CA	73.0	72		F	11/14/2005	Expired while sleeping approximately 12 - 18 hours after Flu vaccine administered. Coroner's case. Additonal term added from autopsy report: Atheroscleric CAD/sr	Y	11/11/2005							N	11/10/2005	11/11/2005	1		PVT	PVT	Dyazide; Enablex; Tegretol; Norvasc; Procardia; Fosamax		CVA, HTN, GERD, Intracerebral aneurysm, Renal insufficiency			1						1	Coronary artery atherosclerosis	FLU3~SANOFI PASTEUR~U1864AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0247363	11/14/2005	MI	72.0	72		F	11/14/2005	Fatigue extreme, fever, Headache, nausea and vomiting, diarrhea.									Y	11/07/2005	11/08/2005	1		UNK	UNK		None	Type II Diabetes Mellitis			1						1	Diarrhoea; Fatigue; Headache; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1912AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247364	11/14/2005	ME	43.0	43		M	11/14/2005	Seven hours after the shot, I felt very hungry. That evening, besides the pain in my arm from the shot, I had a headache and body aches. The next morning I had a fever of 100.3, nausea, body aches, and headache. By noon, my fever dropped to 99.6. By the second day after the shot, I began to feel better. Five days after the vaccine I have sinus congestion.									N	11/09/2005	11/09/2005	0		UNK	UNK	Multi-vitamin, Calcium/Magnesium vitamin, Omega 3-6-9, Glucosamine sulfate.	One or two days prior to the vaccine, I had a scratchy throat. The day of the vaccination I felt as though I was over it.	None			1						1	Headache; Nasal congestion; Nausea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247365	11/14/2005	TX	66.0	66		M	11/09/2005	PNEUMOCOCCAL SHOT WAS GIVEN ON LEFT ARM, SERVERE PAIN DURING THE NIGHT REQUIRING PAIN PILL. INJECTION SITE\AREA SLIGHTLY SWOLLEN AND WARM TO TOUCH. WAS SEEN BY DR. ON 11/09/2005 AND WAS GIVEN ANTIBIOTICS.									Y	11/07/2005	11/08/2005	1	NONE	UNK	UNK		DO NOT KNOW	HIGH BLOOD PRESSURE, GOES TO THE VA FOR ANY MEDICATION			1						1	Injection site swelling; Injection site warmth; Pain	FLU3~SANOFI PASTEUR~U1811AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1039P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247366	11/14/2005	KS	27.0	26		F	11/14/2005	Patient began having symptoms of severe headache 2 days after receiving flu vaccine.  2 days later vomiting began and she was hopitalized for treatment of symptoms.					Y	5			Y	11/02/2005	11/04/2005	2	Spinal tap-WNL	UNK	UNK	Diamox Zoloft	None	Pseudotumor Cerebri			1						1	Headache; Vomiting	FLU3~SANOFI PASTEUR~U1755AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0247367	11/14/2005	TX	2.0	2	.1	F	11/14/2005	Mom called Nurse line and stated;  My daughter had a flu shot the other day. When she woke up this AM(11/05/2005)at about 9:30 AM, she was not responding. She raises her arm up and is just staring into space.				Y					Y	11/03/2005	11/05/2005	2		UNK	UNK	none	none	None known;new pt			1						1	Coma; Staring	FLU3~SANOFI PASTEUR~U1743NA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247368	11/14/2005	KS	26.0	25		F	11/14/2005	Patient received flu vaccine and then started having severe headaches 1-2 days after receiving the vaccination.  Had vomiting 1 day and was hospitalized for treatment of symptoms. Discharge summary states photophobia. msv Discharge summary states intra cranial hypertension. msv					Y	4			Y	11/02/2005	11/04/2005	2	Spinal tap-WNL Discharge summary states increasted AST, alt, bicarb decreased, ch increased.  msv	UNK	UNK	Topamax Diamox zoloft	None	Pseudotumor cerebri			1						1	Alanine aminotransferase increased; Aspartate aminotransferase increased; Blood bicarbonate decreased; Blood chloride increased; Headache; Intracranial pressure increased; Photophobia; Vomiting	FLU3~SANOFI PASTEUR~U1755AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0247369	11/14/2005	NC	64.0	64		F	11/14/2005	Received injection approx. 4PM, 11-10-05.  Became suddenly hoarse followed by a raspy cough at approx. 8PM.  Cough continued despite fluids, food, cough drop.  At 10PM, remembered I had had the flu shot...checked sheet issued to me and noted severe reactions listed.  By 11PM, upper chest area seemed a bit heavy when breathing but did not have shortness of breath.  Cough was subsiding by midnight but noted tachycardia while at rest...125-130/minute.  Nose and nasopharynx became congested and was unable to nose breathe.  Fell asleep only to be awakened at 2AM with severe shaking chill...did not take temp.  Once calmed down, I went back to sleep.  Awakened again about 3AM with another chill but was less intense than earlier.  Was able to breathe some through nasal passages.  By 7AM, I only had a slight frontal headache and the tachycardia plus all other symptoms were absent.  No further problems.  Some soreness and bruising at injection site but no rash, etc.  Took no medications for any of the above listed items.									Y	11/10/2005	11/10/2005	0		UNK	UNK	lipitor aldactazide premarin clonopin					1						1	Chest pain; Chills; Contusion; Cough; Dysphonia; Headache; Injection site pain; Nasal congestion; Tachycardia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247371	11/14/2005	MD	78.0	77		F	11/14/2005	Developed pain and erythema extending from injection site to elbow on Left arm. One day after recieving injection. Treated with keflex 500mg TID X10 days				Y					Y	11/11/2005	11/12/2005	1		UNK	UNK			Arthritis, Emphysema, Asthma, and Graves disease			1						1	Injection site erythema; Pain	FLU3~SANOFI PASTEUR~U1912AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1006P~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247373	11/14/2005	IN	62.0	61		F	11/14/2005	Client given flu vaccine 11/10/05 @9:45 AM .  States she has previously had a skin rash from a bandaid.  A bandaid was left on her arm for approximately  five (5) minutes. At approximately 5:30 PM- 11/10/05 client noted itchy arm with rash, in general area of injection site. Client did apply cold pack to area.On 11/14/05 this CD person noted slightly reddened red raised area 13 by 10 cm & slightly warm to touch. Client reports no prior reaction to flu vaccine given annually the past 3 plus years.									Y	11/10/2005	11/10/2005	0		UNK	UNK			Client noted that she has developed skin rash from bandaid use in the past. Client reports she is allergic to Sulfa			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Rash	FLU3~SANOFI PASTEUR~U1744AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247374	11/14/2005	OH	46.0	46		F	11/14/2005	starting approx 4 hrs after FluMist administered -sneezing, scratchy throat  Starting approx 8 hrs after FluMist administered through 3 days:  mild sore throat, stuffy nose.  Day 2 mild fever (100 F) and tired.									Y	11/11/2005	11/13/2005	2		UNK	UNK	Diovan HCT, Synthroid, Zyrtec, Zoloft					1						1	Fatigue; Nasal congestion; Pharyngolaryngeal pain; Pyrexia; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0247375	11/14/2005	MI	4.0	3		M	11/14/2005	per nurse = 3 to 4 days of large red patches all over.									N	11/08/2005	11/12/2005	4		UNK	UNK		none	none			1						1	Rash macular	DTAP~SANOFI PASTEUR~u1369da~3~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~u1204aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~ue560aa~3~IM~LA~HIB (ACTHIB)~1|IPV~PASTEUR MERIEUX CONNAUGHT~y0343~3~SC~LA~POLIO VIRUS, INACT. (NO BRAND NAME)~1	USA		Influenza
0247377	11/14/2005	NY	5.0	5		F	11/14/2005	My daughter experienced a tonic-clonic seizure 10 days after her second dose of flu vaccine. Then another seizure 1 month later. 2/2/06 Reviewed medical records and confirmed diagnosis of new-onset seizure. The date of ER visit was 11/04/04.  Child was finishing up Ceftin for sinusitis. PMH states child has 'mild cerebral palsy'.  2/2/06 Per telephone f/u the provider indicated that the dates for the two 2004 Fluzone vaccines were 10/8/04 and 11/12/2004.   1/1/10 - follow up - no seizures for 2 yr (since 1 mo. after vaccine)				Y				Y	N	10/08/2004	11/04/2004	27	2/1/06 - Review of medical records indicates EEG date was 11/19/04. Results were stated as 'markedly abnormal EEG. Repetitive sharp waves and spikes are noted primarily in the left central, parietal, and, to a lesser extent, the temporal regions. These have a high propensity for being epileptogenic'.	UNK	UNK	2/1/06 - Per review of ER record, child was taking Ceftin.	2/1/06 - Per review of ER record child was recovering from sinusitis.	Hemiparesis 2/1/06-Per review of ER record, PMH states mild cerebral palsy.			1						1	Convulsion; Electroencephalogram abnormal	FLU3~SANOFI PASTEUR~~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0247378	11/14/2005	VA	67.0	66		F	11/14/2005	Approx 12 hours after receiving flu shot developed vomiting, hoarse voice, chills.  Lasted approximately 12-14 hours.  No specific treatment required.									Y	10/20/2005	10/21/2005	1		UNK	UNK						1						1	Chills; Dysphonia; Vomiting	FLU3~SANOFI PASTEUR~U1674AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247379	11/14/2005	OH	34.0	33		M	11/14/2005	Hives/redness on trunk and head. Difficulty hearing with slight difficulty breathing. Self-treated w/ Benadryl 50mg.									Y	11/10/2005	11/10/2005	0	NONE	UNK	UNK	NONE	NONE	NONE			1						1	Dyspnoea; Erythema; Hearing impaired; Urticaria	FLU3~SANOFI PASTEUR~U1900AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247380	11/14/2005	VA	53.0			F	11/14/2005	C/O blurred vision, cough, blood shot & swollen eyes, tight throat, low grade nausea approximately 4 hours after receiving flu shot.  Seen in ER, giving IV fluids, CT scan, blood work.  Felt back to normal within 24 hours after the shot.				Y					Y				Type of blood work drawn unknown CT - ?Brain?	UNK	UNK	Unknown	None	Unkown			1						1	Cough; Eye swelling; Nausea; Ocular hyperaemia; Throat tightness; Vision blurred	FLU3~SANOFI PASTEUR~U1778AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247382	11/14/2005	VA	47.0	47		F	11/14/2005	Developed very sore arm the day after the flu shot. Lasted over a week, with entire arm being sore. Denies pins/needles, limitation to movement, swelling, numbness, redness.									U	10/26/2005	10/27/2005	1	None	UNK	UNK	Unknown	None	Unknown			1						1	Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA141BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0247383	11/14/2005	NE	41.0	40		F	11/14/2005	Right deltoid reaction - red and swollen - hot. pain down the arm. treated with antibiotics for cellulitis.				Y					Y	11/08/2005	11/09/2005	1		UNK	UNK	Calcium/D,	none	none			1						1	Cellulitis; Erythema; Injection site reaction; Swelling	FLU3~SANOFI PASTEUR~U1828AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0746P~5~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247384	11/14/2005	CO	5.0	4		M	11/14/2005	Patient started becoming feverish and had decrease in activity and appetite (mom did not have thermometer to take temp). Saturday am 11/12/05 Still feverish, decreased appetite and extreme decrease in activity. Seen in office temp 100.8 ax Rt arm swollen w/some tenderness no noted redness. Parents advised to contact in am unless becomes worse before then. Also told to increase fluids. Pt that evening had increase in temp per mom (no reading taken) and had a febrile seizure seen in ER.				Y					Y	11/11/2005	11/11/2005	0		UNK	UNK	none	none	none			1						1	Decreased appetite; Febrile convulsion; Hypokinesia; Pyrexia; Swelling; Tenderness	DTAP~SANOFI PASTEUR~C2104AA~5~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1787EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1189~4~SC~RA~POLIO VIRUS, INACT. (POLIOVAX)~1	USA	Emergency room visit	Influenza
0247385	11/14/2005	AL	8.0	7		F	11/14/2005	Flu Vaccine given on 11/09/2005. Skin reaction on 11/11/2005, beginning on trunk, face, limb, edema of lips, hands, feet. Afebrile, no itching. Saw PMD on 11/11/2005 and ER visit on 11/ 13/2005. Additional PMD visit 11/14/2005 for bloodwork.				Y					U	11/09/2005	11/11/2005	2	None available at this time.	UNK	UNK	nONE	None	None			1						1	Face oedema; Oedema peripheral	FLU3~SANOFI PASTEUR~U1806AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247387	11/14/2005	GA	0.71	0	.7	F	11/14/2005	Pt woke 1 hour after going to sleep screaming uncontrollably. After calming down, was in a dazed state and did not respond to Mom for about 20 mins. held her head cocked back at an angle. No color change. No tonic-clonic activity. After finally becoming responsive, went back to asleep and slept hard the rest of the night.				Y					Y	11/04/2005	11/04/2005	0	EEG completed-normal.	UNK	UNK	Prilosec	None	gastroesophageal reflux			1						1	High-pitched crying	FLU3~SANOFI PASTEUR~U1863AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247388	11/14/2005	OR	79.0	78		F	11/14/2005	Nausea, headache and severe swelling of upper arm and forearm beginning several hours after immunization and continuing for several days.  Attending physician prescribed dicloxacillin.				Y					Y	10/14/2005	10/14/2005	0		UNK	UNK		None	Unknown			1						1	Headache; Nausea; Swelling	FLU3~SANOFI PASTEUR~U1754AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0579P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247389	11/14/2005	CA	44.0	44		F	11/14/2005	10/26 left arm swelling, pain, hot, red, fever - 5 days later. Decreased ROM on left arm. Continued with severe pain 3 weeks later. Annual followup 01/4/2010 There is still a loss of range of motion in shoulder flexion in my left arm. I continue to have increased muscle fatigued when using my arm and some pain. My left arm has these residual problems and is not normal. It is not like my right arm. It has been over a year since the vaccination and I continue to live with these adverse events, will I ever recover?				Y	Y	10			N	10/25/2005	10/26/2005	1		MIL	PVT						1						1	Erythema; Joint range of motion decreased; Muscle fatigue; Oedema peripheral; Pain in extremity; Pyrexia; Skin warm; Cold sweat; Hypersensitivity; Injection site erythema; Injection site pain; Injection site reaction; Injection site swelling; Injection site warmth; Lymphadenopathy; Nausea; Skin burning sensation; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA122AB~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA122AB~2~~LA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Hospitalisation	Influenza
0247391	11/14/2005	PR	4.0	4		M	10/21/2005	Mom says that today 10/21/2005 at 6:00am. Noticed left arm was red, swollen and hot. Was evaluated by DR. Treatment Benadryl, Prelone, Cephalexin, Zyrtec PO. Per f/u with reporter, on 11/17/05 the doctor made a mistake when he filled in the report of patient. The adverse event reproted as life threatening should be changed to that he required emergency room doctor visit.				Y					Y	10/19/2005	10/21/2005	2		UNK	PVT					PR0506	1						1	Erythema; Feeling hot; Oedema	DTAP~SANOFI PASTEUR~U1387AA~5~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~1765FA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y05762~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0603R~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0247392	11/14/2005	PA	47.0	47		F	12/09/2005	(OMIC). Received flu vaccine at approximately 7:30am in leg. 8:15 am developed a scratchy throat, itching of both eyes and numbness of upper lip. As time elapsed, eyes became very reddened and developed prevalent drainage from both eyes. Symptoms persisted for approximately 6-7 hours. The person took Benadryl symptoms abated.				Y					Y	11/03/2005	11/03/2005	0		PUB	UNK	LIPITOR, SELEXA	None	None			1						1	Dry throat; Eye discharge; Eye irritation; Hypoaesthesia; Ocular hyperaemia; Pruritus	FLU3~SANOFI PASTEUR~U1829AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247393	11/14/2005	PA	53.0	53		F	12/07/2005	Within 1 hour of receiving the flu vaccine the persons eyes began to water and developed excessive nasal congestion. Drainage from eyes increased as time went on and then changed to purulent drainage also complained of upper lip numbness. Excessive nasal congestion persisted for hours. Initially, the person took Motrin and symptoms decreased slightly. Later took Dimetapp nasal spray which also decreased symptoms. (OMIC).									Y	11/03/2005	11/03/2005	0		PUB	UNK	Prempro;Pepcid	NONE	NONE			1						1	Eye discharge; Hypoaesthesia; Lacrimation increased; Nasal congestion	FLU3~SANOFI PASTEUR~U1829AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247397	11/14/2005	NY	73.0	72		F	11/07/2005	I am an insulin dependant diabetic. Went into a low sugar coma at 1am following flu shot. Discharge summary states diaphoretic, combative. msv				Y	Y	2			Y	10/25/2005	10/26/2005	1	Discharge summary states increased WBCs, increased BUN. msv	PVT	UNK			Discharge summary states Hx of diabetes melletus, hypertension, cardiomyopathy.			1						1	Aggression; Atrial fibrillation; Blood urea increased; Condition aggravated; Diabetic coma; Hyperhidrosis; Hypoglycaemia; White blood cell count increased	FLU3~SANOFI PASTEUR~U1802BA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0247398	11/14/2005	NE	30.0	30		M	11/08/2005	Muscle aching, cramping in legs, hands, Etc. Serious shaking, shivering, fever, stiffness, headache, fatigue, started about nine hours after vaccine was administered, is continued soreness, stiffness, fatigue a day after. Recovering 11/08/05. 11/12/2005 symptoms completely resolved approx 5 days.									Y	11/07/2005	11/07/2005	0		PVT	PVT	NONE					1						1	Chills; Fatigue; Headache; Muscle spasms; Musculoskeletal stiffness; Myalgia; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U1772AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247400	11/14/2005	OR	36.0	36		F	11/15/2005	Patient came to pharmacy 11/13/05 asked if swelling and pain (from underarm to breast side) was typical of flu shot. These symptoms occurred after flu shot and remained for past 10 days.				Y					Y	10/31/2005	10/31/2005	0		OTH	OTH						1						1	Pain; Swelling	FLU3~SANOFI PASTEUR~U1848AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247401	11/14/2005	AL	66.0	66		F	11/19/2005	Patient stated her right arm (from pneumococcal) was hurting really bad. It was red and swollen and she had a bad headache and neck pain on Saturday. Patient came by office and we looked at her arm. It was red, swollen and hot to the touch. Instructed patient to take a Benadryl and apply heat to the area. Possibly a reaction to the preservatives in the vaccine.									Y	11/11/2005	11/12/2005	1		PVT	PVT	Premarin, Claritin, Zantac, Lortab, Mobic, Prose/ DS, Flonase, Tylenol		GERD, joint pain, peripheral neuropathy, osteoarthritis, menopause			1						1	Erythema; Feeling hot; Headache; Neck pain; Swelling	FLU3~SANOFI PASTEUR~61503~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0386P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247405	11/14/2005	VA	57.0	57		F	11/14/2005	Nausea, stomach cramps - hives symptoms lasted approximately 24 hours.									Y	11/10/2005	11/10/2005	0		PVT	UNK						1						1	Abdominal pain; Nausea; Urticaria	FLUX~UNKNOWN MANUFACTURER~61319~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247406	11/14/2005	MN	88.0	88		F	10/12/2005	Got Flu shot 10/12/05 at 11:00 am. At 3:00 am severe pain woke me up and arm ached like I hit it with a hammer from shoulder to wrist and sick feeling all over, legs ached and weak nausea, chills and sick feeling in stomach. Woke up 4 hours later and pain better put still feels effects of this flu shot. Woke up sick every morning and weak legs with headache. Not allergic to eggs.									N	10/12/2005	10/12/2005	0		PVT	PVT	Blood Pressure, Prozac					1						1	Abdominal pain upper; Asthenia; Chills; Headache; Nausea; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247407	11/14/2005	DC	24.0	24		F	10/20/2005	Immediate syncope after injection, lasting less than 1 minute. V/S 90/60. P 80 placed in recovery position, 450X3, monitored VS, CV status - recovered completely in 20 minutes with BP increase to 110/70 (baseline) P 68.									Y	10/12/2005	10/12/2005	0	NONE	OTH	PUB	Aralen	NONE	Vasovagal syncope, Congenital VSD with murmur	fainting~Vaccine not specified (no brand name)~~12.00~In Patient		1						1	Blood pressure increased; Syncope	FLU3~SANOFI PASTEUR~Z06051~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247408	11/14/2005	IL	45.0	44		F		Patient received vaccinations in right deltoid on 10/31/05. Approximately 6-8 hrs later noticed swelling, redness and pain in area of injections. Symptoms increased patient saw physician on 11/02/05. Prescribed dicloxacillin on 500mg QID X 5 days - currently on 2nd course of Atx. tx.				Y						10/31/2005	10/31/2005	0	N/A	OTH	PVT	Unknown	NONE	Carcinoma S/P lymph node removal L axilla			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1838AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247409	11/14/2005	TX	50.0			M	11/18/2005	Wife reported patient had generalized hives, joint pain, decreased range of motion of arms due to pain, secondary skin infection due to scratching.				Y						10/28/2005				OTH	PVT						1						1	Arthralgia; Infection; Joint range of motion decreased; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1904AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247410	11/14/2005	FL	45.0	44		F		7:30pm, fatigue, dizzy, nausea, dry heaves 11/07/05, 11/08/05 3am nausea, dry heaves, eyes swollen shut, dizzy, joint pain. 11/08/05 temp 96.0, BP 145/82, given clarinex po, phenergan po, phenergan supp. gt. community clinic. 11/09/05 80%  improved, better.				Y					Y	11/07/2005	11/07/2005	0	NONE	PVT	OTH	Nexium, multivitamins		environment dust, PCN, morphine			1						1	Arthralgia; Dizziness; Eye swelling; Fatigue; Nausea; Retching	FLU3~SANOFI PASTEUR~U1866AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247411	11/14/2005	MI	73.0	72		F	11/13/2005	Woke up in the middle of the night with hives, gone the next day. Didn't take anything for the hives									Y	10/25/2005	10/25/2005	0	NONE	PUB	PUB	not given	NONE	not given			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247412	11/14/2005	PA	55.0	54		F	11/07/2005	Onset 10/29/05: Extreme deep body chills, body aches, joint pain, general lethargy, loss of appetite, fever to 104F, headache, chest congestion, cough, stuffy head, runny nose. Total loss of energy  and motivation continues at day 10 of onset. 5 days work lost 11/7/05. Script: cough syrup w/codeine, Eval.  for chest x-ray.				Y					Y	10/21/2005	10/29/2005	8		PUB	UNK		N/A				1						1	Anorexia; Arthralgia; Asthenia; Chills; Cough; Head discomfort; Headache; Lethargy; Pain; Pulmonary congestion; Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1764AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247413	11/14/2005	OR	68.0	68		F		Slight fever not sure of reading, swollen arm from Tuesday to late Sat. Nausea, very ill that night. Felt ill until Friday.									Y	10/25/2005	10/25/2005	0		PVT	OTH	Fosamax, bone, lisinopril, atenolol	No				1						1	Injection site swelling; Malaise; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0247414	11/14/2005	MT	8.0	8		M	11/08/2005	Immediate local swelling at injection site increased in size over next 3 minutes to approx. 1 X 1 1/2 with 1/8 induration , after 3 minutes another site of swelling appeared with circumference of 50 cent piece and induration of 1/8.				Y						11/02/2005	11/07/2005	5		PUB	PUB	N/A	N/A	N/A			1						1	Injection site induration; Injection site swelling; Swelling	FLU3~SANOFI PASTEUR~U1864AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247415	11/14/2005	CA	3.0	2	.8	M	11/10/2005	Per Mom day after Flu vaccine pt hot fever of 101.0F for about 2 hours then had a seizure. History underlying seizure disorder and was on Fentanyl patch which seems to  increase seizures.									Y	10/26/2005	10/27/2005	1		PVT	PVT	Methadone, Oxycodone, chloral Hydrate, Zyrtec, Tranxene,	Pancreatitis	Cerebral Palsy, Seizure disorder, Developmental delay,spastic quadriplegia, cortical blindness.			1						1	Convulsion; Pyrexia	FLU3~SANOFI PASTEUR~U1745AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247416	11/14/2005	AZ	53.0	53		F	11/04/2005	4-5 hours after flu vaccine pt contacted student health with complaints of eyes burning and hurting, shortness of breath, fever. Symptoms reduced over 24 hours. Also with headache and back ache. Didn't seek care in clinic.									Y	11/01/2005	11/01/2005	0	NONE	OTH	PUB	Enalapril, Lovastatin	NONE	sulfa, high cholesterol, hypertension.			1						1	Back pain; Dyspnoea; Eye inflammation; Eye pain; Headache; Pyrexia	FLU3~SANOFI PASTEUR~U1904AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247417	11/14/2005	NC	6.0	5		F	11/09/2005	Leg swollen, red, painful, hot to touch MD feels allergic reaction, treated with ice to area, elevation, prednisone PO, Benadryl, reaction resolved completely within 3 days.									Y	11/03/2005	11/04/2005	1		PVT	UNK		NONE	NONE			1						1	Erythema; Feeling hot; Hypersensitivity; Oedema; Pain	FLU3~SANOFI PASTEUR~U1911AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247418	11/14/2005	WA	49.0	49		F		Within 2 hours of injection severe fatigue, diffuse aching and painful lt shoulder, left neck and left scapular muscles. Pain and fatigue persisted 24 hours. Had to go to bed at 7pm day of shot due to fatigue no fever.									Y	10/27/2005	10/27/2005	0	NONE	PVT	UNK						1						1	Fatigue; Myalgia; Neck pain; Pain; Shoulder pain	FLU3~SANOFI PASTEUR~U1864AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247420	11/14/2005	ND	31.0	30		M	11/02/2005	10/31/2005 fever 103 10/31 fever 99.2 P 84, R22, 4 x 5 induration left triceps. Achiness. Seen by PAC, 11//3/2005 symptoms decreased, fever, redness per pt.									Y	10/28/2005	10/30/2005	2		PVT	UNK	Norvasc, Naprosyn, Avandia, Lorcet	Juvenile rheumatoid arthritis	Codeine, metformin, Celebrex		ND0511	1						1	Erythema; Injection site induration; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U18022AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0346R~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247421	11/14/2005	TX	13.0	12		M	11/09/2005	The patient was given the pneumococcal vaccine polyvalent Pneumovax 23 on 11/7/05. The patient was given the shot subcutaneous on the left thigh. On 11/9/2005 mom called our office stating the child had a pancake size reaction to the shot. The pt had fever 101.0 and neck pain. The pt was treated with Prednisone 20mg and Keflex 500mg.				Y					U	11/07/2005	11/07/2005	0	A CBC was ran	PVT	OTH		NONE	NONE			1						1	Hypersensitivity; Neck pain; Pyrexia	FLU3~SANOFI PASTEUR~U1905AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0082R~1~IM~RA~HEP A (VAQTA)~1|MNQ~SANOFI PASTEUR~U1822AA~1~IM~LL~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PPV~MERCK & CO. INC.~0691P~1~SC~LL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247422	11/14/2005	PA	68.0	67		F	11/07/2005	Left arm erythema edema at site peripheral with streaking to left breast and under arm.									N	11/04/2005	11/06/2005	2		PVT	PVT	Metformin, Synthroid, lisinopril, zeta, volturen		Diabetes mellitus II, Hypertension, HLD, allergies tetnas Lasix Zocor.			1						1	Hypersensitivity; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1904AA~5~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749B~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247423	11/14/2005	IN	1.06	1	.1	F	11/07/2005	MMR, Varicella, Influenza vaccine administered on Oct 27 2005. Red, papular rash began Nov 1 on trunk, spread to extremities, face. later developed mild cough 4 days after onset of rash.									U	10/27/2005	11/01/2005	5	NONE	PVT	PVT		NONE	NONE			1						1	Cough; Erythema; Rash papular	FLU3~SANOFI PASTEUR~01765FA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0301R~1~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0629R~1~~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0247424	11/14/2005	MI	82.0	82		F	10/28/2005	Redness and some swelling in upper arm, generalized aching in arm. Heat in arm extreme fatigue. Happened day after then got.									Y	10/26/2005	10/27/2005	1		OTH	PUB	Zantac, Zetia, Bentyl,Miralax	NONE	Arthritis, Allergy sulfa, vancomycin, Tequin.			1						1	Erythema; Fatigue; Feeling hot; Oedema; Pain	FLU3~SANOFI PASTEUR~U1764AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1046P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247425	11/14/2005	CA		2	.3	M		Swelling and redness whole upper arm and part of forearm.									Y	11/01/2005	11/02/2005	1		PVT	PVT		NONE				1						1	Erythema; Oedema	FLU3~SANOFI PASTEUR~U1765FU~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247426	11/14/2005	NC	1.18	1	.2	F	11/04/2005	Erythema multiforme minor.				Y					Y	10/26/2005	10/27/2005	1	Clinical diagnosis	PVT	PUB	NONE	NONE	NONE			1						1	Erythema multiforme	FLU3~SANOFI PASTEUR~U1765GA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247427	11/14/2005	KY	5.0	5		M	11/07/2005	Rash, Whelps all over									Y	11/04/2005	11/04/2005	0	NONE	PVT	UNK	Potassium;Chlorda;Hydrochlorothiazide, Nalex A-12	Temp 99.2 on 5 days, runny nose, vomiting	Idiopathic hypercalciuria, gross hematuria			1						1	Rash; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500390P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0247428	11/14/2005	IN	43.0	42		M	11/07/2005	Dizziness and chest pain resolved with in 30 minutes. Vasovagal response to Flu shot									Y	11/07/2005	11/07/2005	0	Vasovagal response to Flu shot	PVT	PVT		Shoulder pain and hypertension				1						1	Chest pain; Dizziness; Syncope vasovagal	FLU3~SANOFI PASTEUR~1827AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247429	11/14/2005	TX	43.0	43		M	11/08/2005	Went to the clinic received vaccine on 10/31/2005, injection was given in my left arm. 20-30 min after vaccination I noticed swelling and extreme pain to left arm. Tues 11/01/2005 started having a severe rash and severe pain to left arm. Still having pain in left arm fever and aches. Unknown- reported by patient				Y					U	10/31/2005	10/31/2005	0	NONE	PVT	OTH	HTZ, Lipitor, verapamil, vitamin	NONE	NONE			1						1	Injection site swelling; Oedema; Pain; Pyrexia; Rash	FLUX~SANOFI PASTEUR~U1861AA~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0513P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247430	11/14/2005	NE	13.0	12		F	11/04/2005	Menactra vaccination given 11-2-05 (pm). Pt got sleepy, fatigued later that night. Right arm red, hot swollen - 6 in length 5 around arm. Hard and hurts really bad.  Tx: allergy tablets, Tylenol, ice, Topical allergy creams.									N	11/02/2005	11/02/2005	0		PVT	OTH	NONE	NONE	NONE	~Meningococcal Conjugate (Menactra)~1~12.00~In Patient		1						1	Erythema; Fatigue; Feeling hot; Injection site induration; Oedema; Pain; Somnolence	FLU3~SANOFI PASTEUR~U1903AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1769AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0247431	11/14/2005	OH	72.0	71		F	11/07/2005	Pt's left arm below area where vaccine administered in LD was red, warm, swollen and painful. Pt states onset of symptoms shortly after vaccine given.				Y						11/01/2005	11/02/2005	1		PVT	UNK						1						1	Feeling hot; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~UNK~UNK~~UN~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0247432	11/14/2005	OH	80.0	79		F	11/03/2005	Received vaccine on 11-2-05. Developed itching all over and hives on face and neck. Reports red swollen area on left arm halfway below shoulder and elbow.									Y	11/02/2005	11/02/2005	0	NONE	PUB	PUB		NONE				1						1	Erythema; Oedema; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247433	11/14/2005	NY	1.08	1	.1	M	11/04/2005	11/01 flu vac at 3pm leg sore, hysterical did not sleep, 1102 lethargic vomiting 103.5 Tylenol given, called ER Motrin added. ER visit Viral Syndrome Temp 102.5 suppository N/V. 11/03 feeling better in am, still SX in pm.				Y						11/01/2005	11/01/2005	0		PUB	UNK		Healthy				1						1	Lethargy; Pain; Pyrexia; Viral infection; Vomiting	FLU3~SANOFI PASTEUR~U1765DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247434	11/14/2005	NY	43.0	43		F	11/03/2005	After receiving influenza vaccine at approx. 8:30 am, client presented at office of school nurse (10:00 am) complaints of continual coughing and tightness in her throat. Was sent to hosp. ER where they administered Zyrtec and prescribed Benadryl which was not taken until night time. Client went to work 11/02/05, the next day.				Y					Y	11/01/2005	11/01/2005	0		OTH	PUB	NONE	NONE	NONE			1						1	Cough; Throat tightness	FLU3~SANOFI PASTEUR~U1904AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247436	11/14/2005	TX	41.0	41		F	10/31/2005	States that 24 hours after being immunized at approx 2pm 10/28/2005 starts with chills, temp 100 also c/o massive headache. Arm red and swollen. Cold packs to arm. States today 10/31 she feels better except for the local reaction. States welp was approx 5 inches long with welp at left arm.									Y	10/27/2005	10/28/2005	1		PUB	PUB	Zyrtec, Ales, Ambien PRN	NONE			TX05094	1						1	Chills; Erythema; Headache; Oedema; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U1811AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577R~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247437	11/14/2005	TX	6.0	6		M	11/01/2005	Approx 20 hours after immunization pt c/o itching, rash over body, swelling mother took to ER. Pt given Roceneic Epinephrine updraft, Prelone, Tagamet. Much improvement with treatment.				Y					Y	10/29/2005	10/29/2005	0		PVT	PVT		NONE	Previous vaccine reaction with MMR, DTap,IPV injections 09/29/2003	rash~DTaP (no brand name)~5~4.00~In Patient		1						1	Oedema; Pruritus; Rash	FLU3~SANOFI PASTEUR~U1833BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247438	11/14/2005	TX	2.0	2	.1	M	11/01/2005	Day after Hep A and flu shot received got erythema at the shot site, day after complained that he couldn't walk and eyes were dilated. Taken to ER, diagnosed with inner ear infection and vertigo. Mom comes back look at child and for her was flu like symptoms.				Y					Y	10/26/2005	10/27/2005	1		PVT	PUB					TX05095	1						1	Difficulty in walking; Hypokinesia; Influenza like illness; Injection site erythema; Mydriasis; Otitis media	DTAP~SANOFI PASTEUR~C2277AA~4~IM~~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1838AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0287R~1~IM~RL~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0247439	11/14/2005	OH	64.0	64		M	11/14/2005	Left arm red, swollen, painful decreased range of motion, TX Tylenol, Benadryl PO. Return to office PRN. Assume he recovered.				Y					Y	11/11/2005	11/12/2005	1		PVT	PVT	non?az?, altace, ??, topal, flomax, ???,		Allergy: aspirin, sulfur. Illness: HNT,PVD,GERD,ASVD.			1						1	Erythema; Joint range of motion decreased; Oedema; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA127AB~UNK~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0579P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247440	11/14/2005	OH		18		M	11/11/2005	Chills, following day. Following day difficulty walking and urinating. Being treated with Cestriaxone, Acyclovir. It appears as recovery is pregressing forwar. Another MRI is scheduled in late March. Bladder function continues to improve as does coordination. Pt feels he now has a stutter.				Y					U	10/30/2005	11/07/2005	8		UNK	UNK						1						1	Chills; Difficulty in walking; Dysphemia; Dysuria; Nuclear magnetic resonance imaging; Balance disorder; Dysuria; Fall; Gait disturbance; Headache; Hypokinesia; Pain; Paraesthesia; Peripheral coldness; Pyrexia; Balance disorder; Chills; Difficulty in walking; Dysuria; Encephalopathy; Headache; Immunoglobulins increased; Pain; Paraesthesia; Peripheral coldness; Pyrexia; Sensory disturbance	MNQ~SANOFI PASTEUR~~UNK~~~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|FLU3~SANOFI PASTEUR~U1815AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|MNQ~SANOFI PASTEUR~U1821AA~UNK~~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|FLU3~SANOFI PASTEUR~U1815AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|MNQ~SANOFI PASTEUR~U1821AA~UNK~~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~3	USA	Emergency room visit	Influenza
0247441	11/14/2005	TN	53.0	52		F	11/14/2005	Itching of chest, arms and back about 10 min after Fluzone vaccine. Benadryl 25mg PO given. Episode resolved 30-45 min after Benadryl.									Y	11/14/2005	11/14/2005	0		PUB	PUB		NONE	NONE		TN05058	1						1	Pruritus	FLU3~SANOFI PASTEUR~U1915AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247442	11/14/2005	MA	1.25	1	.3	F	11/14/2005	Localized swelling at 2 injections sites, 1 on each thigh site of right PCV and left Dtap/Hib, about 2.5 cm area swelling, induration. No warmth no tenderness.				Y					N	11/11/2005	11/12/2005	1		PVT	PUB						1						1	Injection site induration; Injection site oedema; Injection site reaction	DTAP~SANOFI PASTEUR~U1349DA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1747AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE707AA~4~IM~LL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0782P~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A25964E~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0247443	11/14/2005	MT	59.0	58		F	11/14/2005	Shot given on 11/07/2005 on Wednesday noticed red area and swelling continued, now on Monday 11/14 redness continues to spread, swelling is the same. Redness is 5 wide and almost all the way around the arm. Called ER they said Benadryl and Ice pack.									U	11/07/2005	11/09/2005	2		OTH	PUB		NONE	NONE			1						1	Erythema; Oedema	FLU3~SANOFI PASTEUR~C1868AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2341AA~1~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0247444	11/14/2005	NY	69.0	68		F	11/04/2005	Pt received the pneumococcal vaccine in the afternoon on 11/2/05 and reports her arm was stiff and sore  that evening. Wednesday the arm was red and had heat to the touch. On Thursday the redness was spreading and her arm was swollen from the shoulder to the torso.				Y						11/02/2005	11/02/2005	0		PUB	UNK	Lipitor,chlcueme, fosamax	just had a cold a month one month ago	PCN			1						1	Erythema; Injection site erythema; Injection site pain; Injection site warmth; Musculoskeletal stiffness; Swelling	FLU3~SANOFI PASTEUR~UU763AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0746P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247445	11/14/2005	NY	51.0	51		F	11/07/2005	Several hours after injection pain at the site by it's difficulty movement of he arm, next day increasing swelling and redness by 9pm on 11/5 thought she should go to the ER. Given Benadryl and ice packs, by 11/7 felling better and improving.				Y					Y	11/04/2005	11/04/2005	0		PUB	UNK	Lipitor, prevacid	NONE	Allergy PCN			1						1	Hypokinesia; Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1824AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0746P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247446	11/14/2005	NY	83.0	82		F	11/09/2005	Pt reports arm was sore, swollen and red beginning Friday eve and continued throughout the weekend. Symptoms resolved by Monday took naproxen for the discomfort.									Y	11/04/2005	11/04/2005	0		PUB	UNK	NONE	NONE	NONE			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~41824AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0746P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247447	11/14/2005	GA	4.0	4		F	11/14/2005	Mild induration, soreness and redness				Y					U	11/04/2005	11/05/2005	1		PVT	PUB			MSG			1						1	Injection site erythema; Injection site induration; Injection site pain	DTAP~SANOFI PASTEUR~AC148002~5~IM~~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1842AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0324~4~IM~~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0602R~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0247449	11/14/2005	PA	53.0	53		F	10/28/2005	A 53 year old female received FluMist vaccine on Oct 9 2005. On Oct 20 2005, while visiting her dentist to have her braces removed, she noticed that she had a left facial droop. Over the next three days after that, the patient reported that she experienced left sided facial paralysis, increased tearing of left eye, strange salty taste in her mouth, inability co close her left eye, pain above and below the left ear, some slurring of speech, left sided headache and hypersensitivity to sounds. On Oct 24 2005, she went to see her primary physician, who, after conducting a cranial nerve exam and based on her symptoms, diagnosed her with Bell's palsy. Lyme disease diagnosis was also considered initially but was leaning toward Bells palsy because she did not have any recent exposure to ticks. Currently, she is being treated with oral prednisone, acyclovir, and amoxicillin. Her symptoms have improved but continued except for ear pain, left sided headache and the slurred speech, which she has recovered from. No other procedures were performed. A call was made to her primary physician but have yet to hear back from him at the time of this report. The reporter assessed the events as possibly related to FluMist.									N	10/09/2005	10/20/2005	11		OTH	OTH	Lisinopril, Prempro		Hypertension		MEDI0003777	1						1	Dysarthria; Dysgeusia; Ear pain; Eye disorder; Facial palsy; Headache; Lacrimation increased; Sensory disturbance	FLUN3~MEDIMMUNE VACCINES, INC.~UNK~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0247450	11/14/2005	WI		57		M	11/11/2005	Shaking all over, chills, fever, next morning felt fine - 11/8 at night was ok. Wednesday night 11/9/05, problems reoccurred similar problems on Thursday night couldn't get warm. Problems usually recurred at night. Today feels slightly warm and fatigued.									Y	11/07/2005	11/07/2005	0		PVT	PVT	enalapril, zetia	NO	NO	chill,fever, 5 days in bed~Influenza (Seasonal) (no brand name)~~30.00~In Patient		1						1	Fatigue; Feeling cold; Feeling hot; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0236840	11/15/2005	CA	57.0			M	11/07/2005	Nurse came into my room - station I -RM 106 many months ago and asked me if I wanted a Flu shot- I told her yes - I also told her I heard that Flu shots could make a person a little sick and that you could run a slight fever also - then she has me sign a paper and then she then gave me the shot then the ext. I don't think the nurse ever reported this at all to VAERS. Keep this highly confidential and if you call me just ask for my name only or write me in my letter from you gets thru to you may be- then last week -ADD nov. 1  to  5 a CNA came into my room and said they were giving out Flu shots I told her then the 1st Flu shot almost killed me- she then left  then another CNA came to my room and she said to me come on the doctor has ordered you a Flu shot you have to take it, she did not say which MD it might have been my MD here, I think for sure. But no name given out to me at all by then I was pretty pissed off and angry about all of this all the CNA told me the Flu shot was new on a better formula so I went into the doctors room and where the NSG was giving out Flu shots in there and her and I got into it she then said I don't want to get into a argument with you, then she gave me my 2nd Flu shot here last week. App between Nov. 1 & Nov.5/05. Then I said to her you give good shots (Flu) and I walked out of the room- pretty much pissed off. I also told her if I started getting sick I sure as hell was going to tell a nurse here. Thankfully got no reactions from the 2nd Flu shot got here last week.			Y						Y					UNK	UNK	Taking a lot of other medication		High BP, Chest pain, allergies			1						2	Neurosis; Unevaluable event	FLU3~SANOFI PASTEUR~U1504AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening	Influenza
0246575	11/15/2005	VA	50.0	50		F	10/17/2005	10cm Erythematous papular reaction. Warm to touch, tender. No systemic effects. Vaccine administered SC based on pkg insert.									Y	10/13/2005				OTH	OTH	Insulin via SC11		Diabetes Mellitus insulin dependent.			1						2	Injection site erythema; Injection site induration; Injection site reaction; Erythema; Feeling hot; Rash papular; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA160AF~1~SC~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA143AD~UNK~SC~~INFLUENZA (SEASONAL) (FLUARIX)~2	USA		Influenza
0247419	11/15/2005	VA	4.0	4		F		Urticaria rash at site of injection				Y					Y	11/05/2005	11/05/2005	0		PVT	PVT			NKDA, NKA			1						1	Injection site urticaria	FLU3~SANOFI PASTEUR~U1854AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247440	11/15/2005	OH	18.0	18		M	11/15/2005	11/07 body ache, headache, fever, trouble urinating. 11/08 ER for above symptoms with inability to walk balanced, cold and tingling sensation in feet and legs inserted a cath and prescribed antibiotics. 11/09 much difficulty walking fell over, returned to ER transferred to Clinic.				Y	Y					10/29/2005	11/07/2005	9		PVT	PVT			Allergic to Amoxicillin			1						2	Chills; Difficulty in walking; Dysphemia; Dysuria; Nuclear magnetic resonance imaging; Balance disorder; Dysuria; Fall; Gait disturbance; Headache; Hypokinesia; Pain; Paraesthesia; Peripheral coldness; Pyrexia; Balance disorder; Chills; Difficulty in walking; Dysuria; Encephalopathy; Headache; Immunoglobulins increased; Pain; Paraesthesia; Peripheral coldness; Pyrexia; Sensory disturbance	MNQ~SANOFI PASTEUR~~UNK~~~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|FLU3~SANOFI PASTEUR~U1815AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|MNQ~SANOFI PASTEUR~U1821AA~UNK~~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|FLU3~SANOFI PASTEUR~U1815AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|MNQ~SANOFI PASTEUR~U1821AA~UNK~~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~3	USA	Hospitalisation	Influenza
0247491	11/15/2005	NY	55.0	55		M	11/07/2005	Acute onset vertigo evening of vaccine hospitalized, treated with valium, released next day. Presently, still not completely well. 1/04/09 Patient feels problem with Dyscaria/buring with urination are temporarily linked to treatment of Flurix.					Y	1			U	11/02/2005	11/02/2005	0		PVT	UNK			GERD, Mild renal insufficiency			1						1	Dysuria; Vertigo	FLU3~SANOFI PASTEUR~U1836AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0247492	11/15/2005	CO	73.0	73		M	11/03/2005	Developed febrile illness shaking, chills, rigors, temp of 102 F on 10/27/2005. By 10/31/2005 he had developed a rash that became confluent in lower trunk. He had fever, aches, myalgias, rash progressed to entire body. Headache but no joint inflammatory symptoms. No reaction in wife or son. -12/15/05 Review of medical record related to initial hospitalization of 11/1/05-11/4/05 indicates final diagnoses of 'serum sickness reaction ? to flu shot' and paroxysmal atrial fibrillation. Other symptoms noted were decreased appetite, arthralgia, sore throat, postnasal drip. 12/15/05 Review of discharge summary for hospitalization from 11/8/05 - 11/14/05 indicates final diagnosis of acute MI, s/p stent placement with improving CHF.					Y	3			Y	10/22/2005	10/27/2005	5	ERS 45 11/01/2005, ERS 20 11/20/2005, Eosinophils 270, C3131, C428 -Per 11-4-05 review of d/c summary troponin enzymes were elevated and ischemic changes were evident on EKG. Cardiac cath revealed 99% occlusion o the mid RCA with decreased distal flow and 80% occlusion of the distal posterolateral branch. Echo indicated a basal inferior infarct, septal posterior hypokinesis, and mild mitral regurgitation. Elevated LFTs were noted, but there was no definite evidence of intrahepatic metastatic disease.	OTH	PUB	Coumadin, Multivitamin, Benadryl,Calcium, Glucosamine.	Pancreatic carcinoma	H/o DVT			1						1	Atrial fibrillation; Cardiac failure congestive; Chills; Coronary artery occlusion; Headache; Liver function test abnormal; Myalgia; Myocardial infarction; Myocardial ischaemia; Pain; Pneumonia; Pyrexia; Rash; Red blood cell sedimentation rate increased; Serum sickness; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA153BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0247496	11/15/2005	IL	68.0	68		F	11/08/2005	Received flu and pneumonia vaccine and developed tightness in center of back and shakiness									U	10/07/2005	10/07/2005	0		PUB	MIL						1						1	Tremor	FLU3~SANOFI PASTEUR~U1744AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0887P~2~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247497	11/15/2005	MT	42.0	41		F	11/09/2005	Patient felt faint, flushed some problem breathing, pale.				Y					Y	11/09/2005	11/09/2005	0		OTH	PVT	Wellbutrin	NONE	Lexapro allergy			1						1	Dizziness; Dyspnoea; Flushing; Pallor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0247498	11/15/2005	UT	62.0	62		M	11/10/2005	Dizzy Tue, Wed, Thurs and increasing. Notice it when he turns head to either side esp.  when holding head to one side. Otherwise feels fine, no headache, no nausea, no cramps , not off balance. Has flushing of face also, oft and on X 3 days.										11/07/2005	11/08/2005	1	142/80 96.4	PUB	PUB	Norvasc 10mg;HCTZ 25mg;Alprazolam, Zoloft 50mg	NONE	Subarachnoid hemorrhage 2 yrs ago - Titanium Clip .25mg			1						1	Body temperature; Dizziness; Flushing	FLU3~SANOFI PASTEUR~U1803AA~5~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247499	11/15/2005	PA	46.0	45		F	11/14/2005	On Wednesday swelling, redness at site of injection; swelling as big as palm of hand. Thursday underarms were itchy. Friday ears were swollen, oozing from ears. Today still itchy, rash starting to go away, sore, used ice packs.										11/07/2005	11/08/2005	1		PVT	PVT	Topamax;Claritin (generic);Aciphex	NONE	NONE			1						1	Ear disorder; Injection site erythema; Injection site swelling; Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247500	11/15/2005	NJ	5.0	4		F	11/15/2005	Her arm was very swollen and hard. When I went to take off band-aid some skin came off. (Sunday 11/13/05). This morning her arm had not changed in size but it was hot then later swelling spread and it was reddish color (11/14/05) 9.										11/12/2005			NONE	OTH	PUB	NONE	NONE	NONE			1						1	Erythema; Feeling hot; Injection site induration; Oedema	DTAP~UNKNOWN MANUFACTURER~2221Aa~5~IM~LA~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~4~IM~RA~HIB (NO BRAND NAME)~1	USA		Influenza
0247501	11/15/2005	PA	81.0	81		F	11/09/2005	Pt reported on 11/09/05 that she experienced a hive on right arm, and swelling and redness from deltoid area to elbow. Pt referred to PCP on 11/11/05 TC from pt. Pt seen by PCP and prescribed Cephalexin 500mg x 3 days and withal prednisolone fm today.									Y	11/07/2005	11/08/2005	1	NONE	UNK	UNK	NONE	NONE	Pt PMH/PSH of left mastectomy w/lymph node removal			1						1	Erythema; Swelling; Urticaria	FLU3~SANOFI PASTEUR~U1823AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247502	11/15/2005	MI	5.0	5		M	11/15/2005	Onset of rash 12-24 days after  immunization									Y	11/09/2005	11/10/2005	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Rash	FLU3~SANOFI PASTEUR~U1911AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247503	11/15/2005	CA	36.0	35		F	11/07/2005	Coughing, wheezing, difficulty breathing, neck glands swelling and sore, tongue felt as though it was thickening. Nebulizer treatment in ofc, albuterol and Medrol Rx's				Y					Y	11/03/2005	11/03/2005	0		PUB	UNK	Darvocet;Soma				CA050077	1						1	Cough; Dyspnoea; Lymphadenopathy; Tongue disorder; Wheezing	FLU3~SANOFI PASTEUR~U1818AB~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247504	11/15/2005	FL	75.0	74		F	11/15/2005	Fever, chills, body, muscle aches 1st day. Large swelling of muscle, redness progressing left arm then into right arm. Then heat and dark coloration at size of both muscles. Dr. said it was some type of infection spreading.				Y					Y	10/11/2005	10/12/2005	1	UNK	PUB	PUB		NONE				1						1	Erythema; Infection; Injection site warmth; Myalgia; Pain; Pyrexia; Skin discolouration; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0247505	11/15/2005	PA	57.0	57		F	11/14/2005	Sore arm, swollen, sensitive, dry mouth, chills, respiratory problems worsened to the pint that had to use a nebulizer and Mvcinex, flushed face. Today still has hard time breathing.										11/11/2005	11/11/2005	0		PUB	PUB	Dyphylline;Zyrtec;Advair;Ambivent;Cipro;Ceanothus;Singulair;Lovasiponf;Combivent		Allergies: seasonal indoor;outdoor;perfume;cleaning products;asthma			1						1	Chills; Dry mouth; Dyspnoea; Flushing; Pain in extremity; Respiratory disorder; Swelling	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247506	11/15/2005	ME	12.0	12		M	11/08/2005	Redness, itching, warmth, at injection location.										11/08/2005	11/08/2005	0		PVT	PUB		NONE	NONE			1						1	Hypersensitivity; Injection site erythema; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U1796AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247507	11/15/2005	IL	0.95	0	1	M	11/05/2005	Vomiting- diarrhea-lethargic- sleepiness, fussy - from 18:15 pm 11/4/02 - till present (noon 11/5/05). Sticking tongue out, smacking lips, moving legs more slowly than previously.									U	11/04/2005	11/04/2005	0	EEG - ordered	PVT	PVT		NONE	NONE			1						1	Diarrhoea; Hypokinesia; Irritability; Lethargy; Somnolence; Tongue disorder; Vomiting	FLU3~SANOFI PASTEUR~U1787FA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247508	11/15/2005	CA	79.0	79		F	11/08/2005	4 days after receiving flu vaccine patient reports she developed a rash in groin/genitalia  (labia) back and arms. Patient clinically stable, no signs of anaphylaxis injection site normal									U	11/02/2005	11/06/2005	4	Labs not done	PVT	PVT	Zyrtec;Ultram;Levothyroxine;Lembivent	Diabetes;Hypothyroid;Arthritis	Levaquin;Claritin;Topica Steroids			1						1	Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61319~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0247509	11/15/2005	IA	77.0	77		F	11/08/2005	About 2 hr. noticed some pain which got worse every hr for 3 or 4 hr. arm started swelling and getting hot which remained for 3 days. Didn't want to use or lift arm for 2 days which let up on 3rd; on 4th day swelling started going down that I could use and pain had let up starting on 3rd day, another person getting shot pneumococcal had same adverse reaction at same time I did.									Y	10/31/2005	10/31/2005	0	NONE	PUB	OTH	Zocor;L-Thyroxine 88mcg	NONE	Ragweed, House dust			1						1	Feeling hot; Hypokinesia; Pain; Swelling; Hypokinesia; Pain; Swelling; Hypokinesia; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0792P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~0792P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~2|PPV~MERCK & CO. INC.~0792P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~3	USA		Influenza
0247510	11/15/2005	IL	70.0	69		F	11/07/2005	My face broke out on the right side in two spots. It was swollen. I went to see doctor. I was given a prescription for Keflex and an antibiotic ointment.				Y					N	10/22/2005	10/24/2005	2		UNK	UNK						1						1	Face oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA120AA~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0247511	11/15/2005	OH	8.0	8		F	11/09/2005	11-05-05: mild warm slight raised area, C/O soreness at site and redness (left thigh). 11-06-05 worsened to more C/O soreness at site. Activities (physical ) continued. 11-07-05 (Mon) better less sore. 11/08/05 (Tue) pink area noted left thigh 19x21 and MD referred to ED. 11/08/05; ED visit: Dx Cellulitis, Tx; Keflex times 10 days.  Improving as of 11-09-05				Y					Y	11/04/2005	11/05/2005	1	Clinical Dx: Cellulitis	PUB	PUB	NONE	NONE	In remission (Brain Ca hx)			1						1	Cellulitis; Injection site erythema; Injection site swelling; Injection site warmth; Myalgia	FLU3~SANOFI PASTEUR~U1815AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247512	11/15/2005	NE	2.0	2	.1	F	11/09/2005	Urticaria treated with Benadryl				Y					Y	10/19/2005	10/19/2005	0		PVT	PVT	Vigamox	NONE	A topic Dermatitis;Constipation;Allergies; Amoxicillin			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1905AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247513	11/15/2005	MD	54.0	54		F	11/03/2005	Redness/Swelling at injection site and warmth, area measured 50 mm x 30 mm;raised area									Y	11/02/2005	11/03/2005	1		PUB	UNK	Synthroid	NONE	Hashimoto Disease; Mild Asthma			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1764AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247514	11/15/2005	PA	47.0	46		F	11/09/2005	Developed numbness and tingling in all 10 digits hands and feet 11/8/05 at 3 am that has progressed to affecting the entire hands, and predominantly plantar aspect of feet. Feels week. Unstable with Romberg testing. Able to stand and walk.									U	11/07/2005	11/08/2005	1	CBC;CMP;CRP;ESR;VIT B12;TSH;EBV;IGL;IGM;RPR;Arterial blood gas	UNK	UNK		Sinusitis;COPD;RAD;Anxiety	As in 18 Hlo mononucleosis			1						1	Asthenia; Hypoaesthesia; Paraesthesia	FLU3~SANOFI PASTEUR~0183AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247515	11/15/2005	MN	65.0	64		F	11/08/2005	Developed and area of erythema 4.5cm x 6.5cm around the area she received pneumovax. Area was tender and slightly hardened. Patient also experiencing some vomiting. Discharge summary states rash, drug reaction, diarrhea. msv. Per follow up from 01/31/2006 Had problems with R shoulder rotator cuff very soon after going home from hospital. Moderate pain has diminished to slight pain 2 months later. Also had marked increase in arthritis of shoulder, hips, knees, back now relieved by anti inflammatories, but still a problem. It is difficult to say whether the above is related or not, but the timing is certainly coincidental.									U	11/07/2005	11/08/2005	1	Discharge summary states leukocytosis. msv Medical records states anemia, drug levels decreased. msv	PVT	PUB	Unknown	NONE	Unknown Discharge summary states hyperlipedemia, hypertension, migraine, osteoporosis, drug allergy. msv			1						1	Anaemia; Arthritis; Diarrhoea; Drug interaction; Drug level decreased; Injection site erythema; Injection site induration; Injection site pain; Leukocytosis; Pain; Rash; Vomiting; Anorexia; Cellulitis; Chills; Diarrhoea; Gastrointestinal sounds abnormal; Injection site erythema; Injection site swelling; Limb discomfort; Malaise; Pain in extremity; Pruritus; Pyrexia; Rash; Skin discolouration; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA141AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1006P~1~SC~RA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~SC~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0247516	11/15/2005	KS	62.0	62		F	11/04/2005	10/24/05 at 7:00 pm, patient having chills, joint pain, headache and nausea. 10/25/05 at 7:30 am, she has rash on trunk, neck and upper arms. Rash did not itch or have discomfort was a spotty appearance. 10/26/05 at 7:20 am, rash was solid red, did not itch. Felt like a fever. 10/27/05, all symptoms were gone.									Y	10/24/2005	10/25/2005	1	NONE	PUB	PVT	NONE	NONE	NONE			1						1	Arthralgia; Chills; Erythema; Feeling hot; Headache; Nausea; Rash	FLU3~SANOFI PASTEUR~U1830AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247517	11/15/2005	NE	42.0	41		F	11/09/2005	Pain and tenderness that began in left arm and progressed across upper back.									Y	10/14/2005	10/31/2005	17		PVT	PVT						1						1	Back pain; Pain	FLU3~SANOFI PASTEUR~U1832BA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247518	11/15/2005	MO	65.0	65		F	11/09/2005	Nausea, hives of mouth and eye and headache. Treated with Benadryl.									Y	10/19/2005				OTH	OTH	Benadryl	A few days later				1						1	Headache; Nausea; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247519	11/15/2005	MN	46.0	46		F	11/09/2005	Developed erythema, tenderness, swelling and warmth at injection site. Seen in urgent care and given Keflex, symptoms improved.				Y					Y	11/06/2005	11/07/2005	1		PVT	PVT	NONE	NONE	Glaucoma			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA141AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1006P~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247520	11/15/2005	CT	74.0			F	11/07/2005	Arm was hot (from shoulder to elbow) swollen, unbearable to touch for 4 days on 5th day start, it started to improve, and it was very itchy.														OTH	OTH						1						1	Feeling hot; Oedema; Pain; Pruritus	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~UNK~UNK~~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0247521	11/15/2005	ID	0.53	0	.5	M	11/19/2005	Fever 105.8 watch closely over the next few days, if fever lasts more than 5 days Follow in clinic. Or if not felling well, having trouble breathing or other concerns, or if non blanching rash appears.				Y					Y	11/04/2005	11/06/2005	2	NONE	PVT	PUB						1						1	Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B010AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UNK~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A56077C~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0247522	11/15/2005	NV	47.0	46		F	11/08/2005	Pain that radiated up arm and neck, plus down arm to hand. 2 days of body aches, chills, followed by on going pain from injection site to elbow that increases when arm is raised up from side. Its a shooting, aching, nerve irritation like pain, persisting to today.									U	10/18/2005	10/18/2005	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Chills; Injection site pain; Neuralgia; Pain	FLU3~SANOFI PASTEUR~U1794AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247523	11/15/2005	OH	19.0	19		F	11/08/2005	Pt received vaccine in the am on  10/24/2005. Then per pt report, she was seen in the hospital ER with the following symptoms, fever, severe shaking, vomiting. Pt states the ER Dr told her she was having a reaction to vaccines she received on 10/24/2005. Pt is pregnant and EDC is 01/09/2005.				Y					Y	10/24/2005	10/25/2005	1		PUB	PVT	Prenatal Vitamins	NONE	Pregnant			1						1	Hypersensitivity; Pyrexia; Tremor; Vomiting	FLU3~SANOFI PASTEUR~U1804AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0946P~1~UN~LA~HEP B (RECOMBIVAX HB)~1	USA	Emergency room visit	Influenza
0247524	11/15/2005	IL	64.0	64		F	11/08/2005	The day after Pneumonia injection my upper right arm from elbow to shoulder was red, hot to touch, swollen and very painful. It looked like cellulitis. The inner arm was worse that the outer area where the actual shot was given it lasted 4 days.									Y	11/01/2005	11/02/2005	1	NONE	OTH	PVT	Tavist	NONE	Allergic to pollen, dust, smoke etc			1						1	Cellulitis; Feeling hot; Injection site hypersensitivity; Injection site oedema; Injection site pain; Injection site reaction	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0792P~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247525	11/15/2005	MT	67.0			M	11/09/2005	Pt received influenza vaccine at 9:00 arrived at ER at 14:45 stated throat feels swollen. Solumedrol 125 mg IM given at 15:05. Pt monitored for 2 hours by Physician and then DPC to home.				Y					Y	11/01/2005	11/01/2005	0	NONE	OTH	UNK			Allergic to DCN			1						1	Pharyngeal oedema	FLU3~SANOFI PASTEUR~U1832BA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247526	11/15/2005	GA	5.0	5		F	11/10/2005	Right arm with marked redness, firmness and swelling with 24 hours of flu vaccine. No fever, no decreased ROM. Improved by 72 hours with Benadryl and Ibuprofen.				Y					Y	11/07/2005	11/08/2005	1		PVT	PVT	NONE	NONE	NONE			1						1	Erythema; Injection site induration; Oedema	FLU3~SANOFI PASTEUR~U1858AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247528	11/15/2005	IL	7.0	6		F	11/01/2005	7 days after flu mist pt diagnosed with right middle and right lower lobe pneumonia with effusion.									Y	10/24/2005	10/31/2005	7	CXR	PVT	PVT	NONE	Mild Cold symptoms	NONE			1						1	Pleural effusion; Pneumonia	FLUN3~MEDIMMUNE VACCINES, INC.~500389~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0247529	11/15/2005	TX	11.0	11		M	11/09/2005	Pt was seen on 11/04/05 and was given the poly valent Pneumovax 23. The shot was given subcutaneous in the left thigh. On 11/09/05 the patient presented with a coin (dollars size swelled area. The patient had no fever or other symptoms.									U	11/07/2005	11/08/2005	1		PVT	OTH						1						1	Oedema	FLU3~SANOFI PASTEUR~U1905AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0082R~1~IM~RL~HEP A (VAQTA)~1|MNQ~SANOFI PASTEUR~U1822AA~1~IM~LL~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PPV~MERCK & CO. INC.~0691P~1~SC~LL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247530	11/15/2005	NC	9.0	9		F	11/10/2005	Patient received 0.50 mg of vaccine per prescribed dose in left deltoid. She walked out of exam room, talked with her father and turned to me stating, Mommy I am going to throw up, she became very pale, diaphoretic and fainted. 5cc of Benadryl given PO and she recovered completely about 30 mins later.									Y	11/05/2005	11/05/2005	0		PUB	PVT		NONE	NONE			1						1	Hyperhidrosis; Nausea; Pallor; Syncope	FLU3~SANOFI PASTEUR~U1836AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247531	11/15/2005	MA	60.0	59		M	11/07/2005	4-4 1/2 hours after flu vaccine received, developed total body aches, headache and lightheadness. Had difficulty sleeping that night due to headache. Symptoms subsided by									Y	11/05/2005	11/05/2005	0	NONE	PUB	PUB	HCTZ		Hypertension			1						1	Dizziness; Headache; Insomnia; Pain	FLU3~SANOFI PASTEUR~U1854AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247533	11/15/2005	NY	26.0	25		F		26 Year old female reported feeling itchiness, trembling and lightheaded approximately 40 minutes after receiving vaccine went to Emergency Dept. TX with Benadryl PO.				Y					Y	11/01/2005	11/01/2005	0	NONE	PVT	PVT	NONE		Latex gloves reaction rash, reported by patient			1						1	Dizziness; Pruritus; Tremor	FLU3~SANOFI PASTEUR~U1778AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247535	11/15/2005	AS	62.0	62		F	10/19/2005	Symptoms per patient report, swelling, arm pain, low grade fever, on 13th and 14th better on 15th then nausea and diarrhea on 16th. By 17th all symptoms were cleared.									Y	10/13/2005	10/13/2005	0		PVT	PVT			Morphine, sulfa, codeine, Hypertension, glaucoma, coronary artery disease, migraines		LA051101	1						1	Diarrhoea; Nausea; Oedema; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1756AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0746P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247536	11/15/2005	CA	5.0			M	11/02/2005	A nurse practitioner reported that a 5 year old male received FluMist on Oct 24 2005, and that the next day, the patients mother called the office to report that the patient experienced facial swelling on the areas of the forehead, nose and cheeks. On Oct 26 2005, the patient was seen at the clinic. The reporter examined the patient and noted tenderness on the swollen areas. She was informed by the mother that the patient was given oral Benadryl starting on Oct 25 2005. The reporter ordered an x ray of the fact to rule facial trauma. However, as of Nov 1 05, the x ray has not been performed yet per the patients mother. The patients clinical outcome is unknown at this time. The reporter assessed the event as possibly related to FluMist.									U	10/24/2005	10/25/2005	1		PVT	UNK					MEDI0003774	1						1	Swelling face; Tenderness	FLUN3~MEDIMMUNE VACCINES, INC.~500392P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0247537	11/15/2005	MN	31.0	31		M	10/26/2005	A male physician reported that 2 days after he received FluMist on Oct 11 2005, he experienced low grade fever, chills and myalgia. On Oct 17 2005, he noted that he had a fever of 103 degrees Farenheit and he started to cough. A chest x ray was performed (date unspecified) and revealed pneumonia. He was treated with combination of amantadine and Levaquin (levofloxacin). The patients clinical outcome was unknown at the time of report. The reporter causality is not provided. Follow up - This is a non serious spontaneous case from a physician involving pneumonia. The reporter causality is not provided. This case is submitted according to VAERS Surveillance accelerated reporting agreement for FLUMIST. A 31-year-old male physician reported that 2 days after he received FLUMIST on 11Oct2005, he experienced low grade fever, chills and myalgias. On 17Oct05, he noted that he had a fever of 103 degrees Farenheit and he started to cough. A chest x-ray was performed that revealed pneumonia. He was treated with a combination of amantadine and LEVAQUIN. The event is considered resolved. The reporter causality is not provided.									U	10/11/2005	10/13/2005	2	Chest X-Ray, Pneumonia	OTH	OTH	Concomitant Drug (s) Not reported				MEDI0003780	1						1	Chills; Cough; Myalgia; Pneumonia; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0247538	11/15/2005	VA	64.0	64		M	11/15/2005	Pt presented w/Ataxia, areflexia; Dysarthria; Ophthalmoplegia; paresthesia weakness, ptosis; buphthalmos working diagnosis is Miller  Fisher Syndrome a type of Guillain Barre Syndrome. As per annual follow up report 68 yr old male admitted for increasing ataxia, distal paresthesias and opthamoplegia, arreflexia, vocal cord paralysis.					Y	8			U	11/05/2005	11/09/2005	4	Anti GQ b1 AB sent (not back)	PUB	MIL	Tylenol, Lisinopril, Tiazac, Prevacid, Plavix, Maxide.	NONE	COPD; A-FIB; HTN; GERD			1						1	Asthenia; Coordination abnormal; Dysarthria; Eyelid ptosis; Miller Fisher syndrome; Ophthalmoplegia; Paraesthesia; Vocal cord paralysis	FLU3~SANOFI PASTEUR~U1930AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0247540	11/15/2005	PA	57.0	57		F	10/22/2005	Excruciating pain in right arm starting approx. 3 hrs after vaccination. Could not sleep that night. No relief from any position. Arm still cannot be raised w/o pain after 5 weeks (11/15/05). Concerned about long-term effects.									N	10/07/2005	10/07/2005	0		OTH	PUB		NONE	NONE			1						1	Hypokinesia; Insomnia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0247541	11/15/2005	VA	53.0	52		F		Abdominal pain; chills; no nausea, vomiting; diarrhea or fever				Y					Y	11/09/2005	11/09/2005	0	NONE	PUB	UNK	Prevacid;ERT	NONE	Dilaudid			1						1	Abdominal pain; Chills	FLUX~UNKNOWN MANUFACTURER~61319~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0247565	11/15/2005	FL	67.0	67		F	11/15/2005	I received the injections for Flu and Pneumonia on Nov. 14 at 3:00 p.m. I started having symptoms around 6:00 or 6:30 p.m. I started feeling like the phrendulom (sp) at the back of my throat was swelling.  I started having trouble swallowing, this went on for about an hour, it seemed to get a little worse, at that time I decided to take a Benadryl tablet.  After about an hour to hour and a half I started feeling better.  I have been O.K. since.									Y	11/14/2005	11/14/2005	0		UNK	UNK		None	Penicillin,Shell Fish			1						1	Dysphagia; Oedema; Throat tightness	FLUX~UNKNOWN MANUFACTURER~~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0746P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247566	11/15/2005	MA	57.0	57		M	11/15/2005	2 hours after, itching; 10 hours after hives all over body except face;received intravenous pepcid, pretanisone, diphenhyramine. same occured the next night, 9 November.				Y					Y	11/08/2005	11/08/2005	0		UNK	UNK		none	aspirin			1						1	Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0247567	11/15/2005	FL	53.0	52		F	11/15/2005	Within 4-5 hours of receiving the shot, I developed a dry cough, became very tired, then came down with severe chills.  I took an aspirin then went to bed. The symptoms passed within about 5-6 hours, and I was perfectly fine after that time.									Y	10/21/2005	10/21/2005	0		UNK	UNK	none	none	none			1						1	Chills; Cough; Fatigue	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247568	11/15/2005	IA	70.0	70		M	11/15/2005	Resident noted with a diffuse area of erythema (19x12cm) and warmth to right deltoid area. Venous distention noted to right lower arm. Denies pain or itching. No resp.distress, no hives, tongue WNL, handles secretions normally. No change in ROM or hand grips.  Physician notified, New order for Benadryl 25mg po q6hr prn.  11/13/05 Only slight pinkness remains to area.									Y	11/08/2005	11/10/2005	2		UNK	UNK		none	Cephalosporins   CVA  Dementia HX of Fx Shoulder, ribs			1						1	Erythema; Feeling hot; Vasodilatation	FLU3~SANOFI PASTEUR~U1803AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1004P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247569	11/15/2005	TX	50.0	50		F	11/15/2005	First flu vaccine, ever. Evening of vaccine, approx 7:30, sudden onset of fatigue, aches and joint pain (wrists, ankles, hips,knees, shoulders...all over). Tightness in chest, breathing discomfort, and coughing when trying to take deep breath. Feeling like heart flutters. Headache (inc neck and ears). Symptoms have continued for 6 days now with a little improvement. Seeing Dr Thursday: 11/17.									Y	11/09/2005	11/09/2005	0		UNK	UNK	Levoxil/Armour compound (30/60)	None	Probable Hashimoto's Thyroiditis			1						1	Arthralgia; Cardiac flutter; Chest discomfort; Cough; Dyspnoea; Fatigue; Headache; Pain	FLU3~SANOFI PASTEUR~U1817AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247573	11/15/2005	WI	33.0	32		F	11/15/2005	3.5 hours post vaccination-scratchy throat, tightness in chest, blood-shot eyes, light-headed, dizzy				Y					Y	10/28/2005	10/28/2005	0	EKG done-normal	UNK	UNK	None	None	allergic to kiwi			1						1	Chest discomfort; Dizziness; Ocular hyperaemia; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U1752JA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247574	11/15/2005	WI	0.34	0	.3	F	11/15/2005	Patient given Influenza vaccine, is not recommended for under age 6 months. CDC Hot line called 1-800-232-2522.									U	11/14/2005	11/14/2005	0	None	UNK	UNK	none	none known				1						1	Medication error	DTAP~GLAXOSMITHKLINE BIOLOGICALS~c14ab002aa~2~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~u1743ka~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0656n~1~IM~LL~HIB (PEDVAXHIB)~1|IPV~SANOFI PASTEUR~10265~2~SC~RL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~a67186k~2~SC~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0247575	11/15/2005	IN	2.0	2	.3	F	11/15/2005	SHE SLEPT FOR 3 HOURS RIGHT AFTER THE SHOT.  SHE BEGAN RUNNING A FEVER UPON AWAKING, STATED HER HEAD WAS HURTING, THEN A HALF HOUR LATER STARTED VOMITING.  SHE VOMITED OFF AND ON FOR 3 HOURS OR SO.									Y	11/14/2005	11/14/2005	0		UNK	UNK	NONE	NONE	NONE			1						1	Headache; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247576	11/15/2005	IL	46.0	46		F	11/15/2005	Patient temporary passed out after receiving flu shot.  She warned nurse in advance that she would, as she does with all injections.  Nurse told patient to drink something cold when she came to.									U	11/15/2005	11/15/2005	0		UNK	UNK						1						1	Loss of consciousness	FLU3~EVANS VACCINES~61549~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0247578	11/15/2005	SD	45.0	44		F	11/15/2005	Patient's eyes burned immediately and shortly thereafter developed a sore throat, coughing, and nasal discharge.  Early a.m. on 11-11-05, the day following vaccine, patient noticed she was severely hoarse and is still completely hoarse today 11-15-05.									N	11/10/2005	11/10/2005	0		UNK	UNK	Celebrex, Vitamin, Premarin, Calcium	None	Allergies to Cats/Dogs, Metal, Reglan.  Some environmental allergies.			1						1	Cough; Dysphonia; Eye irritation; Pharyngolaryngeal pain; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500 389P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0247579	11/15/2005	VA	53.0	53		M	11/15/2005	Received vaccine about 9:30AM 11/14/05 At 2AM 11/15, c/o nausea, generalized malaise & body aches. Fainted, then vomited x3 over the next one hour or so. Experienced chills about 5AM.				Y					Y	11/14/2005	11/15/2005	1	none	UNK	UNK	Flonase	none	seasonal allergies			1						1	Chills; Malaise; Nausea; Pain; Syncope; Vomiting	FLU3~SANOFI PASTEUR~U1836AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247580	11/15/2005	MD	51.0	50		F	11/15/2005	Approximately 3 to 4 hours after flu shot, I began experiencing shortness of breath, tightening of the chest and deap breaths caused dry coughs.  When symptoms progressed I contacted nurse triage and was told to take benedryl and breathe in moist air (hot shower running).  Approximately 40 minutes after taking the benedryl, sypmtoms began to clear.  No symptoms were present upon awakening the following morning (today).									Y	11/14/2005	11/14/2005	0		UNK	UNK	None	No illness at time of vaccination	None			1						1	Chest discomfort; Cough; Dyspnoea	FLU3~SANOFI PASTEUR~U1911AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247581	11/15/2005	MA	62.0	61		F	11/15/2005	3:00 PM school nurse received Flu vaccine, 3:15PM  began c/o itch, rash present on left flank-Benadryl 50mgm.po, B/P 160/82. Called PCP, he requested no epinephrine be given because her B/P going up. Patient c/o swollen tongue and chest pain-transported by ambulance to Hospital.				Y					Y	11/14/2005	11/14/2005	0		UNK	UNK		No	She had other allergies but not to eggs. She had high blood pressure and was treated with medication.			1						1	Chest pain; Hypertension; Pruritus; Rash; Tongue oedema	FLU3~SANOFI PASTEUR~U1826AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247582	11/15/2005	MS	3.0	2	.7	M	11/07/2005	Mother called 20 minutes past flu shot stating that child had raised red rash.  Counseled mother to take to pmd.  pt saw Dr at Clinic.  Denies problems with previous vaccine or flu shot				Y					Y	11/14/2005	11/14/2005	0		UNK	UNK		NONE	NONE		MS05018	1						1	Rash erythematous	FLU3~SANOFI PASTEUR~U1831AB~2~ID~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247584	11/15/2005	MS	67.0	66		F	10/14/2005	PT STATES EDEMA AND SORENESS BEGAN 2 HRS PAST INJECTION. REFERRED TO PT'S PRIVATE PHYSICIAN. PT SELF TREATED WITH COOL COMPRESSES AND IBUPROPHEN AND BENADRY.  SAW PRIVATE MD.  GIVEN MEDROL				Y					Y	10/13/2005	10/13/2005	0		UNK	UNK					MS05019	1						1	Oedema; Pain	FLU3~SANOFI PASTEUR~U1806AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247585	11/15/2005	MS	69.0	69		F	10/24/2005	FLU AND PNEUMONIA ADMIN IN R ARM @ PT'S REQUEST.  SAW PMD ON 10/24/2005 WITH RED STREAKS GOING DOWN ARM BACK TO ELBOW.  A PMD TREATED WITH ANTIBIOTICS				Y					Y	10/21/2005	10/24/2005	3		UNK	UNK		None			MS05020	1						1	Erythema	FLU3~SANOFI PASTEUR~U1811AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247586	11/15/2005	NM	6.0	5		M	11/15/2005	Per mother, child developed hives 5 hours after receiving the flu vaccine and the hives remained for 4 days. No fever reported. Mother notified pediatrician and was advised not to be concerned.									Y	11/10/2005	11/10/2005	0		UNK	UNK						1						1	Urticaria	FLU3~SANOFI PASTEUR~U1085AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247588	11/15/2005	NY	61.0	60		F	11/15/2005	a. Aches, pains, high fever--103 for two days b. Onset of cold like symptoms-Still occuring c. Large swelling and pain at injection site-Has still not returned to normal after one week.										11/09/2005	11/10/2005	1		UNK	UNK						1						1	Injection site oedema; Injection site pain; Pain; Pharyngitis; Pyrexia; Rhinitis	FLU3~SANOFI PASTEUR~U1825CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~0748P~UNK~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0247589	11/15/2005	CT	46.0	45		F	11/15/2005	First time patient ever received flu vaccine. Vaccine administered in left deltoid.  Patient was asked to remain in room for 10 minutes to observe for any adverse events.  Within 5 minutes patient reported numbness and tingling center of tongue and began traveling down into throat and esophagus.  On observation patient had no difficulty breathing or swallowing.  No edema of tongue or throat.  Within 10-15 minutes patient's symptoms resolved.									Y	11/08/2005	11/08/2005	0		UNK	UNK						1						1	Hypoaesthesia; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA148BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0247534	11/16/2005	WI	75.0	74		M	11/03/2005	C/O onset of neck pain 1 day after receiving flu vaccine									U	10/26/2005	10/27/2005	1		PVT	OTH	Combivent, L-Thyroxin, Fosamax, Spiriva, Viagra, Calcium, Lipitor, Azmacort, aspirin, Albuterol inhaler		COPD, osteoporosis, hypothyroid, elevated cholesterol			1						1	Neck pain	FLU3~SANOFI PASTEUR~U1833BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247592	11/16/2005	MN	55.0	54		F	11/10/2005	Very few minutes, pt felt rush heart racing like a panic attack, dizzy. Tongue felt like it was swelling			Y						Y	11/03/2005	11/03/2005	0		PUB	UNK	Lipitor, Cymbalta, Trazodone					1						1	Dizziness; Heart rate increased; Panic reaction; Tongue oedema	FLUX~UNKNOWN MANUFACTURER~U1911AA~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0247594	11/16/2005		21.0			M	10/24/2005	Small pox vaccine received 10/05/2005, Flu vaccine 10/13/2005, Generalized rash and itching developed 10/16/2005. Also with sores in mouth at ER on 10/17/2005. Rash described as diffuse vesicular rash with some lesions 6-7 mm in circumference on the back. rash on scalp, neck, trunk, arms, legs with scattered macules, papules, water blisters. Involvement in the mouth with an erythematous stomatitis with a soft whitish exudate. Dx of erythema multiforme major possibly 2 hours to vaccines (small pox and less likely to flu discharges 10/24/2005.					Y					10/13/2005	10/16/2005	3		UNK	UNK	Aveeno, Triamcinolone cream, Benadryl, Mycostatin, Decadron elixir, Vancomycin, Polysporin ointment, Domeboro topically, hydroxyzine, Whirlpool baths.					1						1	Blister; Erythema multiforme; Mouth ulceration; Pruritus; Rash; Rash macular; Rash papular; Rash vesicular; Skin ulcer; Stevens-Johnson syndrome; Stomatitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1	USA	Hospitalisation	Influenza
0247596	11/16/2005	IL	30.0	30		M	11/11/2005	We had an incident at our flu shot clinic where the patient had a reaction to the flu shot. The patient was a 30 year old male, DOB 5/13/75 he had no previous flu shot. I verified with the patient if he was allergic to eggs and he stated that he was not. The patient was Hispanic but spoke perfect English. I gave him the shot an the he told him to stay in the store for 15-20 minutes and if he felt funny then he would come back to me. He came back about 7-10 minutes later and said that he couldn't feel his arm and that his hands were swelling. I told him to sit down and asked if he was having trouble breathing. He said no. I told my technician , who was helping me to call 911. She did and gave them the info that was available. As the patient was sitting and I was talking to him. he said he was feeling a little dizzy and his head went down.. I said stay with me.. talk to me.. he was. And I gave him the first Epi-Pen dose about 2 minutes after we got off the phone with 911. After I did that I was talking to him ad he started seizing. I held his head and was talking to him. When the seizure was over he was talking to me again and saying that his head hurt. After about another 2-3 minutes, I gave another Epi-Pen and then the paramedics came and took him away after doing the vitals. He was talking when he left. If you have any questions, please don't hesitate to call.				Y					Y	11/11/2005	11/11/2005	0		OTH	OTH						1						1	Convulsion; Dizziness; Flat affect; Headache; Oedema peripheral	FLU3~SANOFI PASTEUR~U1806AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247597	11/16/2005	LA	76.0	76		F	11/11/2005	Itching, redness at site. Reported to vaccination on 11/11/05 @ 08:50 am.									U	11/08/2005	11/08/2005	0	NONE	PVT	PVT		NONE	Allergy to sulfa, codeine			1						1	Injection site erythema; Injection site hypersensitivity; Pruritus	FLU3~SANOFI PASTEUR~U1866AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247598	11/16/2005	NY	62.0	62		F	11/04/2005	Nausea, sweaty, tired, clammy per patient. BP 108/60, P78 r20.  Has received flu vaccine X 5 years.									U	11/04/2005	11/04/2005	0		OTH	PVT			Asthma			1						1	Cold sweat; Fatigue; Hyperhidrosis; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLVA151BA~2~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0247599	11/16/2005	NY	37.0	37		M	11/04/2005	Shaking, nauseous, vomiting X 4. Shallow breather per patient. BP 140/80 P=60 R=18. First time received flu vaccine.									U	11/04/2005	11/04/2005	0		OTH	PVT			None Known			1						1	Hypoventilation; Nausea; Tremor; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLVA151BA~2~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0247600	11/16/2005	IA				U		Pain bilateral calves, tender 72-96 hrs. Post influenza vaccine, normal reflexes.									U	11/06/2005	11/10/2005	4		OTH	PVT		NO	NONE			1						1	Muscle spasms; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247601	11/16/2005	NH	5.0	5		M	11/13/2005	Vasovagal syncope after Flumist, approx. 15 minutes after administration.									Y	11/08/2005	11/08/2005	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Syncope vasovagal	FLUN3~MEDIMMUNE VACCINES, INC.~500390P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0247602	11/16/2005	OH	37.0	37		F	11/10/2005	10:20 flu vaccine administered. 10:35 color pale c/o lightheaded and tired, slurred speech, HR 72, R 20, BP 128/32, VS normal stable. 10:40 c/o feeling like having hang over, vision blurred. 11:00am notified. Transferred from Dr office via car driven by co-worker, refused  EMS, hospital 2 miles away no distress noted at transfer. 12:20 returned from doctor with orders to go home and sleep. Color normal, weakness and slurred speech remain. Instructed to go to ER if symptoms worsen or remain. 11/11/05 Follow up with patient after reaction following Fluzone injection yesterday. She states that she is feeling much better and has spoken with her physician this morning and was advised to stay home from work and drink plenty of fluids. She is currently experiencing a sore throat and thinks she may have had a  fever accompanied by chills during the night. Headache and muscle aches are present at this time. She was asked if she had ever had a similar experience and she said these same symptoms had occurred five years ago after her last flu shot. She stated that two weeks ago she had a gastrointestinal virus (vomiting and diarrhea) for 4 days. Advised patient not to take a flu sot in the future without consulting a physician about her reaction to the vaccines received five years ago and this year.				Y					U	11/10/2005	11/10/2005	0		OTH	PVT						1						1	Asthenia; Chills; Dizziness; Dysarthria; Fatigue; Hangover; Headache; Myalgia; Pallor; Pharyngolaryngeal pain; Pyrexia; Vision blurred	FLU3~SANOFI PASTEUR~U1866AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247603	11/16/2005	OH	3.0	2	.7	M	11/08/2005	Broke out in hives on both legs, arms, buttocks 1 1/2 hours after receiving flu vaccine. Last 24 hours. Received Benadryl and Zyrtec.				Y					Y	11/07/2005	11/07/2005	0		PVT	PVT						1						1	Urticaria	FLU3~SANOFI PASTEUR~U1788HA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247604	11/16/2005	VA	32.0	31		F	11/14/2005	11/09/05 3:30pm began to feel chills and body aches upon returning home felt stiffness in neck muscles. T-101.5F. 4am sweats upon arising  felt fine but weak. 11/10/05 am felt itching on chest and back, no rash visible. 11/11/05 Friday am asymptomatic none of the s/s were presented in the health services dept.									Y	11/09/2005	11/09/2005	0	N/A	PUB	PUB	NONE	None specific at this time	None			1						1	Asthenia; Chills; Hyperhidrosis; Musculoskeletal stiffness; Pain; Pruritus	FLU3~SANOFI PASTEUR~U1826AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247605	11/16/2005	WA				F		At 12:00am after receiving vaccine - felt fluid running down back of throat - went to bathroom - swollen face with left eye conjunctival hemorrhage. Better as of 11/14/05.										11/09/2005	11/10/2005	1		PUB	OTH	Synthroid	NONE	hyperthyroidism			1						1	Conjunctival haemorrhage; Face oedema	FLUN3~MEDIMMUNE VACCINES, INC.~500393P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0247606	11/16/2005	DE	39.0	39		F	10/21/2005	10/13/05 11:55am c/o feeling weird and thinking everything is funny and of being able to hear heart beat in my ears.  BP=126/76, P=80, strong and regular. respiration regular and non labored. loud  heartbeat kept her awake 10/13/05 pm called private MD office 10/14/05 and was advised by nurse on call MD to seek emergency care if in acute distress. Did not seek emergency care was evaluated by pt  on 10/17/05. Ability to hear heart beat continued until 10/19/05, C/O numbness in mouth on 10/18/05 and 10/20/05 - resolved 10/21/05.				Y						10/13/2005	10/13/2005	0		PUB	PUB	Elavil prn, soma		migraine headaches. back pain, allergic to robitussin expectorant, albuterol, percocet and nicoderm patches	felt tired, had strong heart beat times several minutes post vaccination~Influenza (Seasonal) (no brand name)~4~35.00~In Patient		1						1	Paraesthesia oral	FLU3~SANOFI PASTEUR~U1794AA~5~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247607	11/16/2005	CT	52.0	51		F	11/14/2005	Flu vaccine administered in morning. Developed 100.4 fever (oral) that evening  with body aches, headache and cough. Fever gone by second day. Cough remains and headache. Has developed laryngitis. Unsure if it is related to cough. Still with symptoms 11/14/05.									Y	11/10/2005	11/10/2005	0	NONE	PVT	PVT	NONE	NO	NO			1						1	Cough; Headache; Laryngitis; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62013~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0247608	11/16/2005	CT	55.0	55		F	11/14/2005	Approx. 36 hrs after receiving injection of Flu vaccine developed headache and body aches. R4lieved with Advil. Denied fever or cough. Headache persists to present (aa/14/05).										11/10/2005				PVT	PVT	Tarka,Avandamet, liato, Protonix, water pill, potassium supplement	NO	NONE			1						1	Headache; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62013~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0247609	11/16/2005	OH	53.0	53		F	11/10/2005	Pneumovax given. AM became pain very sore- temp and Urticaria 103-104F. Chills - muscle and joint aches X 5 days. Treatment: rest, Tylenol, Keflex 500mg, qid.				Y						11/02/2005	11/02/2005	0		OTH	PVT						1						1	Arthralgia; Myalgia; Pain; Pyrexia; Urticaria	FLU3~AVENTIS PASTEUR~U1839AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0579P~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247610	11/16/2005	PA	0.36	0	.4	F	11/15/2005	-temp elevation. urticarial diffuse rash developed 1 hour after receiving flu vaccine. Parent brought baby back to the office to be examined. Ck after injection no change in respiration's, muscle tone  activity. Treatment: prescribed Orapred 2-5 P.O. BID X 5 days. Child examined 11/2/05. No rash noted - resp-distress, - change in behavior, eating well. Follow-up appointment scheduled in 1 week.									Y	11/01/2005	11/01/2005	0		PVT	PUB						1						1	Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U1804AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247611	11/16/2005	PA	0.06	0	.1	M	11/13/2005	no adverse event noted.									Y	10/14/2005				PVT	PUB			NONE			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U1804AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247612	11/16/2005	MO	1.11	1	.1	M	11/15/2005	Morbilliform rash - trunk and extremities - no treatment.									N	11/01/2005	11/15/2005	14	NA	PVT	PUB	albuterol nebulizations, tylenol or motrin	NONE	heart murmur, ashleaf, spot			1						1	Rash morbilliform	FLU3~SANOFI PASTEUR~U17GSEA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0602R~1~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0562P~1~SC~~VARICELLA (VARIVAX)~1	USA		Influenza
0247613	11/16/2005	GA	77.0	77		F	11/15/2005	Whelps over entire body with itching  1st Benadryl OTC 2nd Steroid injection Dytan bid; medrol dose pack TAD				Y					N	11/10/2005	11/12/2005	2		PVT	UNK			NORVASC			1						1	Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61501~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0247614	11/16/2005	GA	4.0	4		M	11/08/2005	Pain at injection site X 2 days. Redness, swelling from injection site on upper arm to elbow X 5 days									Y	10/06/2005	10/07/2005	1		PVT	UNK						1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1746AA~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247615	11/16/2005	IL	7.0	7		F	11/15/2005	Pt was given flumist vaccine in approx. 15-20 minutes pt called from car and stated that pt's throat felt clogged. No drooling. Breathing ok. Per Dr recommendation pt sent to Glenbrook ER.  This information was included in the 15-day VAERS report submitted on 20 JUNE 2006.				Y					Y	11/15/2005	11/15/2005	0		PVT	PVT			NKA, MVP			1						1	Throat tightness; Throat tightness	FLUN3~MEDIMMUNE VACCINES, INC.~500393P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500393P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Emergency room visit	Influenza
0247633	11/16/2005	PA	54.0	54		F	11/16/2005	SORE THROAT; CHEST CONGESTION; COUGH; HOARSENESS (LARYNGITIS); WEAKNESS									N	11/07/2005	11/09/2005	2		UNK	UNK		NONE	SEASONAL ALLERGIES			1						1	Asthenia; Cough; Laryngitis; Pharyngolaryngeal pain; Pulmonary congestion	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247634	11/16/2005	MI	0.61	0	.6	M	11/16/2005	Patient broke out in hives, starting where the injection was given.  The hives continued to  spread over his whole body.  Mom states that she noticed the hives about an hour after child received immunization.  Client was taken to the emergency room and mom states that client was treated with some medication and sent home with oral benadryl.  Mom states that client is doing well today.  Mom states that ER physician told her that it could be a reaction to the eggs found in the flu vaccine.				Y					Y	11/15/2005	11/15/2005	0	none	UNK	UNK	none	Client had a fever on 11/13/05.	none			1						1	Urticaria	FLU3~SANOFI PASTEUR~u1823aa~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247635	11/16/2005	AZ	12.0	12		F	11/16/2005	SENSORY NEUROPATHY LEFT ARM DOWN TO FINGERS WITHOUT LOSS OF STRENGTH.									U	11/12/2005	11/12/2005	0		UNK	UNK	VITAMINS	NONE	DRUG REACTION TO HEPATITIS A AND PENICILLIN			1						1	Neuropathy	FLU3~SANOFI PASTEUR~U1807AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247638	11/16/2005	MA	78.0	78		M	11/16/2005	3-4 days after Flu shot given on 11/2/05, started having itching all over (feet first) (805 legs 205 arms). Saw doctor PCP 11/11/05 then saw dermatologist 11/4/05. Tx Erythema Multiforme probably 2 days to flu shot. Treated with soaks and cream.				Y					Y	11/02/2005	11/05/2005	3	Dermatologist	PUB	UNK	ASP;Allopurinol (Gout);Claritin	NONE	2/14/05 Right THR			1						1	Erythema multiforme; Pruritus	FLU3~SANOFI PASTEUR~U1831AB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247639	11/16/2005	CA	47.0	46		M	11/16/2005	Dizziness, hot flashes, paleness - all beginning approx. 18 hours after vaccination, subsiding 5-6 hours later.									Y	11/14/2005	11/15/2005	1		UNK	UNK	aciphex, lexapro					1						1	Dizziness; Hot flush; Pallor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247640	11/16/2005	HI	54.0	54		F	11/16/2005	Was administered vaccine around 3:30 p.m. on 11/11/2005.  Approximately 3 hours after receiving vaccine had sudden tightness of chest, which worsened rapidly - similar to severe asthma attack.  Took Primatene tablet, and conditions graduadally lessened until I was able to breathe more freely in about 3 hours.  Was very surprised as the suddenness of the attack, as was feeling fine.  This episode included, in addition to severe tightness in chest, extreme difficulty breathing, and wheezing. (I was a childhood asthma sufferer, with occasional attacks as an adult, but haven't had one for over 10 years.  Also had severe allergies when infant through age 5, including dairy products and eggs, but outgrew those and have no current adverse reaction to eggs or dairy products.)									Y	11/11/2005	11/11/2005	0		UNK	UNK						1						1	Asthma; Chest discomfort; Condition aggravated; Dyspnoea; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247641	11/16/2005	KY	53.0	52		F	11/16/2005	Received Via Employee Immunization.  Developed shortness of breath and a dry, hacking cough.  Treated with Diphenhydramine 50mg IM and Methylprednisolone 80mg IM.  Symptoms resolved				Y					Y	10/28/2005	10/28/2005	0		UNK	UNK						1						1	Cough; Dyspnoea	FLU3~SANOFI PASTEUR~U18688~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247642	11/16/2005	CO	10.0	9		M	11/16/2005	Generalized tonic clonic seizure at night in bed witness by family.  Patient had received flu vaccine 8 days prior.  Additional terms added from DIS. Summary rec'd 10/30/2005:WBCinc, BP inc, Magnesium inc, platelets inc./sr Discharge summary states confusion. msv				Y	Y	1			Y	10/20/2005	10/29/2005	9	EEG was abnormal confirming seizure disorder.	UNK	UNK	None	None	None			1						1	Blood pressure increased; Confusional state; Convulsion; Electroencephalogram abnormal; Laboratory test abnormal; Platelet count increased; White blood cell count increased	FLU3~SANOFI PASTEUR~U1832BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0247645	11/16/2005	OH	71.0	71		F	11/16/2005	About 2 hr. after receiving vaccine, pt began to get dizzy, couldn't focus to read, gradually worsened, and pt became nauseated due to dizziness about 7 pm- cont. for approx. 36 hours.  Also had pain in neck									Y	10/19/2005	10/19/2005	0	N/A	UNK	UNK	Dyazide Synthroid	None	Seasonal allergies, hypertension, hypothyroid			1						1	Dizziness; Nausea; Neck pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA130AB~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0247646	11/16/2005	CA	63.0	62		F	11/16/2005	Headache, raspy throat, watery and then crusty eyes, chills									Y	11/15/2005	11/15/2005	0		UNK	UNK						1						1	Chills; Dry throat; Eye discharge; Headache; Lacrimation increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247648	11/16/2005	OR	43.0	43		M	11/16/2005	ARTHRALGIA, LOCALIZED EDEMA AND ERYTHEMA AT INJECTION SITE, SITE OF PNEUMOVAX/ LT ARM, LESS THAN 24 HOURS FOLLOWING VACCINATION WITH PNEUMOVAX AND INFLUENZA. PT WAS SEEN IN CLINIC ABOUT 24 HOURS FOLLOWING THE VACCINES AND IS BEING TREATED WITH ANTIBIOTICS AND ANTI-IMFLAMITORIES.				Y					U	11/15/2005	11/15/2005	0	NONE	UNK	UNK	ASA, LORAZAPAM, VICODIN,LEXAPRO, TRICOR,ZETIA, LOVASTATIN, LISINOPRIL, NIASPAN, IMDUR, ATENOLOL	NONE	HX MI, COPD, CVD, HTN			1						1	Arthralgia; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1863AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1006P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247651	11/16/2005	NC	35.0	34		F	11/16/2005	Had Fluarix vaccine 11/14/05 in AM. On 11/15/05 while driving home noticed vaccinated arm felt tired. Better in AM but symptoms return as day progressed. Continued to have these symptoms.									N	11/14/2005	11/15/2005	1	NONE	OTH	OTH	Allegra;Nasonex;Singulair	Allergies-Dust mites	Dust mite-Allergies			1						1	Fatigue; Myalgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA120AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0247652	11/16/2005	CA	14.0	14		F	11/16/2005	At 01:30, 16 1/2 hours after immunization, awoke with urticaria, generalized, and slight tongue swelling. Given Benadryl. Urticaria gave in AM. No respiratory symptoms.									Y	11/15/2005	11/15/2005	0	NONE	PVT	PVT	NONE	NONE	Mild set genial allergic Roes notes			1						1	Tongue oedema; Urticaria	FLU3~SANOFI PASTEUR~U1832BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVA019AA~1~IM~RA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U1780AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0247653	11/16/2005	FL	53.0	53		F	11/15/2005	Got progressively worse. Felt sleep, tired, fatigued, nausea, dizzy. By noon next day ached head to toe, fever close to 100 degrees; took aspirin.									U	11/14/2005	11/14/2005	0		OTH	OTH	NONE		NONE			1						1	Dizziness; Fatigue; Nausea; Pain; Pyrexia; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247654	11/16/2005	NM	52.0	51		F	11/16/2005	Pt given flu vaccine in right deltoid. Pt arm turned red, pt c/o throat tightness and chest tightness. Benadryl 50 mg im gulln. Motrin 600mg PO gulln.									Y	11/16/2005	11/16/2005	0	NONE	PVT	PVT	Zantac;Percocet;Xanax;Methocarbamol;Naprosyn	NONE	Allergic to PCN			1						1	Chest discomfort; Erythema; Throat tightness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61128~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0247655	11/16/2005	CA	2.0	2	.4	M	11/17/2005	Arm - shoulder to elbow swollen by 24 hrs after shot 2/3 of length. 1/4 width red, warm. RX with claritin 5mg, motrin, and cool compresses.									Y	11/14/2005	11/15/2005	1	N/A	PVT	PVT						1						1	Injection site erythema; Injection site oedema; Injection site warmth; Oedema peripheral	FLU3~SANOFI PASTEUR~U1787EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247389	11/17/2005	CA	44.0	44		F	11/15/2005	10/25/2005 Tuesday as flu vaccine was being administered, I complained of severe burning pain in my arm, By that evening my arm was painful and starting to swell. 10/26 in am my arm was more edematous and I felt more burning pain. 10/27 around 11:00am I went to ER. There was now edema from my elbow to my shoulder. Pain persisted. The ER doctor thought it was a local reaction and it would pass. 10/28 all symptoms were worse. 10/29 edema was not into the soft tissue in my back, under my arms and into my left breast. The pain was severe. It felt like nerve pain (burning)and as though my arm was constricting. The ER doctor prescribed Prednisone 40 mg for 4 days. He stated he had no idea what was happening. 10/30 by Sunday evening the generalized edema and pain was worse and there was now redness and heat at the injection site. I felt clammy and nauseated. I went to the ER. they started IV Vancomycin and admitted me. I was there for 10 days. 10/31 - Nov 3 labs and CT scan were negative. I believe staph was cultured from my nose. A second Iv Antibiotic was added. Dr discontinued the antibiotics on Nov 3, as I was not responding. During this time the edema worsened and the severe pain continued. Also the lymph nodes under my arms and in my groin were swollen and painful. He then thought it might be an allergic response. Solumedrol was started. 11/04 - 11/07 there was some improvement in the area of the lymph nodes (less swelling and pain) and the edema in my arm was slightly reduced but the pain remained. On Monday 11/07 Dr called in an allergist/immunologist. 11/08 an MRI was done it showed layers of fluid in the soft tissues. I also saw the allergist. her assessment was that this was not an allergic reaction by a atypical reaction to an irritant in the vaccine. 11/09 Put on PO Prednisone. 11/10 Discharged on Prednisone in declining dose for seven days. Follow up appointment with allergist. (not seen as yet). 11/15 Tuesday there has been some improvement in the generalized soft tissue edema. The edema in my arm is slightly improved. The burning pain also seems to be slowly resolving.				Y	Y	10			N	10/25/2005	10/25/2005	0		UNK	UNK	Methadone, Neurontin, Topamax, Elavil, Arthrotec; KLONOPIN; CELEXA; ZYRTEC; SINGULAIR; ATENOLOL		Medical record states allergy, cancer of overy and pain. msv			1						2	Erythema; Joint range of motion decreased; Muscle fatigue; Oedema peripheral; Pain in extremity; Pyrexia; Skin warm; Cold sweat; Hypersensitivity; Injection site erythema; Injection site pain; Injection site reaction; Injection site swelling; Injection site warmth; Lymphadenopathy; Nausea; Skin burning sensation; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA122AB~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA122AB~2~~LA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Hospitalisation	Influenza
0247663	11/17/2005	NY	30.0	30		F	11/15/2005	(OMIC). Initial report received from a patients parent on Nov 7 2005. A 30 year old female patient with a medical history of asthma and an allergy to dog and cat dander received a left deltoid injection of Fluzone SV 2005-2006, lot number U1764AA, on Nov 4 2005. The route of administration was not reported. The patient had received no previous doses. Five to ten minutes following vaccination, the patient fainted. The patient was also shaking. She was examined in an emergency room and discharged. Per the reporter, an electrocardiogram was normal, and the patient had an elevated white blood cell count. There were no illness at the time of vaccination, although, the patient had an unspecified illness a week prior to vaccination. Other medications were birth control pills. At the time of this report, the recovery status was unknown.				Y					U	11/04/2005	11/04/2005	0	EKG Normal, WBC Elevated	OTH	UNK			The patient has a history of asthma and an allergy to dog and cat dander. She had no illness at the time of vaccination, although, she was sick a week prior to vaccination. Other medications were birth control pills.		200502365	1						1	Syncope; Tremor; White blood cell count increased	FLU3~SANOFI PASTEUR~U1764AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247664	11/17/2005	IL	49.0	49		F	11/15/2005	Initial report received from a health care provider on Nov 8 2005. A 49 year old female patient with a possible history of asthma or COPD received an intramuscular deltoid injection of Fluzone no preservative 2005 2006. lot number U1802BA, on Oct 25 2005. Eight days later, she developed sensitivity to touch and an alternate sensation of burning and cold to both lower extremities. On Nov 5 2005, these symptoms became worse with the additional onset of stuttering. On Nov 7 2005, the patient experienced decreased feeling, an inability to move both lower extremities and was hospitalized. Per the reporter, results are pending for an MRI of the brain without contrast and a lumbar puncture culture, VDRL, bacteria, virus, and fungal. At the time of this report, the diagnosis was unconfirmed. The patient was treated with prednisone starting on Nov 2 2005 and discontinued at the time of hospitalization. The patient denied illness at the time of vaccination, and other medications were not reported. Number of previous doses was reported as past years. At the time of this report, recovery status was not reported.					Y	0				10/25/2005	11/02/2005	8		UNK	UNK			The patient had a pre existing medical history of possible asthma or COPD. The patient denied illness at the time of vaccination, and other medication were not reported. Number of previous doses of vaccine was reported as past years.		200502373	1						1	Dysphemia; Hyperaesthesia; Paraesthesia; Paralysis; Peripheral coldness; Sensory disturbance; Skin burning sensation	FLU3~SANOFI PASTEUR~U1802BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0247665	11/17/2005	OH	47.0	47		F	10/28/2005	A 47 year old nurse, with prior history of asthma, reported that she began to experience chest tightness, wheezing, scratchy throat, tiredness, nasal congestion, headache, runny nose, body ache and dehydration, 3 days after she received FluMist on Oct 7 2005. She was seen by her primary physician and was given nebulization treatments for her wheezing. She was also prescribed an unspecified antibiotic which had to be changed to Avelox (moxifloxacin) and oral decongestants. She also received intravenous hydration as she felt dehydrated. As of Oct 28 2005, the patient continues to have nasal congestion, headache, runny nose, tiredness and body aches. All other symptoms have resolved. The patient also stated that other members in her family received FluMist but did not experience any adverse event. The reporter assessed the events as possibly related to FluMist.				Y					N	10/07/2005	10/10/2005	3		PVT	OTH			Asthma		MEDI0003775	1						1	Chest discomfort; Dehydration; Fatigue; Headache; Nasal congestion; Pain; Pharyngolaryngeal pain; Rhinorrhoea; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500389P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0247666	11/17/2005	CA	7.0	7		M	10/28/2005	A pharmacist reported that a 7 year old male experienced pneumonia, fever and cough one day after receiving FluMist on Oct 21 2005. On Oct 22 2005, the patient developed a fever of 100 degrees F. On Oct 23 2005, he was brought to an urgent care center where he was prescribed oral Ceftin (Cefuroxime). On Oct 24 2005, the high grade fever persisted (temperature unrecalled) and the patient started to cough. On Oct 27 2005, a chest x ray showed pneumonia on the right upper lobe. He was seen at the doctors office, where he was given one dose of Rocephin (Ceftriaxone) via intramuscular injection. He was then sent home with prescription of oral Augmentin (co amoxiclav). The patient has not yet recovered from the adverse events at the time of this report. The reporter assessed the events as possibly related to FluMist. Additional information has been requested.				Y					N	10/21/2005	10/22/2005	1	Body Temperature 10/22/2005 100 degrees F, Chest X ray 10/27/2005Pneumonia right upper lobe.	OTH	OTH					MEDI0003794	1						1	Cough; Pneumonia; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500388P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0247667	11/17/2005	CA	50.0	50		F	11/03/2005	12 hours later very painful, 24 hours whole left arm swollen, numbness down left arm from armpit to palm. 2 large red welts with itching. Extremely painful 72 hours left hand tingly and cooler than right side. 1 welt still visible 6 under injection site.									Y	10/31/2005	10/31/2005	0		PUB	UNK						1						1	Erythema; Hypoaesthesia; Oedema; Pain; Paraesthesia; Peripheral coldness; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1802AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247668	11/17/2005	PA	14.0	13		F	11/14/2005	Left upper arm became red, warm to touch swollen and sore. pt had also developed nausea, vomiting, and headache. Red area 5 inches x 7 inches indurated.				Y					Y	11/10/2005	11/11/2005	1	NONE	PVT	PVT	Singulair, Advair	Upper respiratory infection	Asthma, Seasonal allergies			1						1	Erythema; Feeling hot; Headache; Injection site induration; Nausea; Oedema; Pain; Vomiting	FLU3~SANOFI PASTEUR~U1850AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1768AA~1~~LL~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PPV~MERCK & CO. INC.~0607R~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247669	11/17/2005	GA	45.0	45		F	11/08/2005	Received flu vaccine 10:30am noticed itching 10 mins after then hot and aching after 30 minutes. Returned to health dept 11:15am referred to MD.				Y					Y	11/08/2005	11/08/2005	0		PUB	PUB	Flonase, Synthroid, Fem Hrt	Sinus congestion				1						1	Feeling hot; Pain; Pruritus	FLU3~SANOFI PASTEUR~U1930AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247670	11/17/2005	VA	65.0	65		M	11/09/2005	Pt stated he noted a bump at injection site after receiving a flu shot 2 weeks ago. Added he did not look at area but started scratching it through his shirt. Denies redness, swelling or pain. During assessment of site by medical director it was noted to be a dry, raised area the size of 1 x 0.9 cm. No signs of infection was noted and director advised pt to keep area clean and if it becomes reddened or swollen to return.									Y	10/25/2005	10/25/2005	0	NONE	PUB	PVT	Ranitidine, Lotrel, Protonix, Tylenol	Post laser surgery right shoulder	ASA, ibuprofen		VA05019	1						1	Dry skin; Injection site nodule; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U1747AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247671	11/17/2005	PA	22.0	21		F		Upset stomach, nausea, felt hot, sweaty no fever.									Y	11/04/2005	11/04/2005	0	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Hot flush; Hyperhidrosis; Nausea; Stomach discomfort	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA139AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0247672	11/17/2005	PA	44.0	44		M		Lightheadedness about 1 1/2 hour after injection, BP increased, HR irregular, felt faint, dry mouth, overall achiness. PCP diagnosed allergic reaction.				Y					Y	11/10/2005	11/10/2005	0	PCP diagnosed allergic reaction, Completed EKG, lab work, UA	OTH	PVT	Benazepril, HCTZ, ASA	NONE	NKDA, Hypertension			1						1	Blood pressure increased; Dizziness; Dry mouth; Heart rate irregular; Hypersensitivity; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA139AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0247673	11/17/2005	NC	1.02	1	.0	M	11/14/2005	Urticaria at site of RVL immunization given Prevnar seen by MD at health dept Dx allergic reaction right upper thigh at site of immunization 4th dose of Prevnar given at that site.									Y	11/08/2005	11/08/2005	0	NONE	PUB	PUB		NONE	NONE			1						1	Hypersensitivity; Injection site reaction; Injection site urticaria	FLU3~SANOFI PASTEUR~U1787AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE582AA~4~IM~LL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~Y02982~3~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0850P~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A83578P~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0247674	11/17/2005	AZ	5.0	4		M	11/11/2005	Foster mom reports 2 redness and 1 diameter lump in area of IPOL site. LA SQ. DTaP given in Left deltoid.									Y	11/09/2005	11/09/2005	0		PVT	PUB						1						1	Injection site hypersensitivity; Injection site induration; Injection site reaction	DTAP~SANOFI PASTEUR~C2253AA~2~~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1755AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB092AB~1~~RA~HEP B (ENGERIX-B)~1|IPV~SANOFI PASTEUR~Y0496~2~SC~LA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0247675	11/17/2005	WA	38.0	38		F	11/12/2005	Severe piercing pain rippling from left side of pelvis to right side occurring 5 minutes after vaccination (Flu) to left deltoid muscle.									Y	10/27/2005	10/27/2005	0	NONE	OTH	PVT	Effexor, Wellbutrin, Zoloft	NONE				1						1	Pain	FLU3~SANOFI PASTEUR~U1903AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247676	11/17/2005	CT	71.0	70		F	11/07/2005	Within 5 minutes I had of the flu shot, a fast heart beat. It lasted 1 hour.									Y	10/31/2005	10/31/2005	0		PUB	UNK		NONE	NONE			1						1	Heart rate increased	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247678	11/17/2005	WA	38.0			F	10/26/2005	Large reddened 60 mm area round.														PVT	OTH						1						1	Erythema	FLU3~SANOFI PASTEUR~U184AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247679	11/17/2005	PA		66		F		< 24 hours after Flu immunization, had complete loss of function of legs, falling, extreme weakness. That slowly resolved over 24 - 36 hours.				Y					Y	11/03/2005	11/04/2005	1	NONE	OTH	OTH	Lotrel, ASA, Lotensin HCT, Evista	NONE	Hypertension, OA, Diabetes mellitus 2			1						1	Asthenia; Fall; Movement disorder	FLU3~SANOFI PASTEUR~U1846AA~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247680	11/17/2005	NE	71.0	70		M	11/10/2005	Left upper arm red and warm to touch, non indurated. Approx 22 x 12 cm erythema. TX antibiotic, antihistamine.									Y	11/08/2005	11/10/2005	2		PVT	PVT	Zestril, Crestor, Albuterol nebulizer	NONE	NKA, HX bladder cancer, Prostate Cancer, Hypertension, high cholesterol, Chronic obstructive pulmonary disease.			1						1	Erythema; Feeling hot	FLU3~SANOFI PASTEUR~U1870AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0791P~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247681	11/17/2005	WA	46.0	45		F	10/28/2005	Feeling of being light headed, dizziness, itching then rash.									Y	10/27/2005	10/27/2005	0		UNK	UNK						1						1	Dizziness; Pruritus; Rash	FLU3~SANOFI PASTEUR~U1864AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247682	11/17/2005	CA	56.0	55		F	11/09/2005	Enlarged lymph node in supraclavicular area in same side as vaccine was given. No pain, no fever. Malaise, sore throat 11/10/2005 4:00 am.									Y	11/08/2005	11/09/2005	1	NONE	PVT	PVT	Estrogen		NONE	swollen lymph nodes~Td Adsorbed (no brand name)~~45.00~In Patient|fever, aches~Influenza (Seasonal) (no brand name)~~20.00~In Si		1						1	Lymphadenopathy; Malaise; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U1865AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247683	11/17/2005	MA	58.0	58		F	11/13/2005	Developed fever, body aches, but the most unusual, unexpected reaction was intense red color in both eyes, discharge swollen eyes, with pain, symptoms lasted into the second day. cleared on 3rd day.									Y	11/03/2005	11/03/2005	0	NONE	OTH	PUB	Levoxil for thyroid	3rd week after broken wrist other wise ok.	Allergies to various pollens, dust mites, mold, severe allergy to IVP dye.			1						1	Eye discharge; Eye pain; Eye swelling; Ocular hyperaemia; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247684	11/17/2005	CA	1.16	1	.2	M	11/11/2005	Received DPaT in right upper thigh on 11/09/2005, had fever first night (Tactile), Resolved. Today has warm swollen local reaction 5 x 5 cm. NO fever, eating well. No systemic SXS, no red streaks.									U	11/09/2005	11/09/2005	0		PVT	UNK						1						1	Feeling hot; Injection site oedema; Pyrexia	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B006AA~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U17436A~5~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247685	11/17/2005	NY	53.0	53		F	11/01/2005	Left upper extremity swollen swollen and painful on moving blotch the size of a silver dollar. Cool compress, Tylenol for pain. Discomfort 2-3 days at site of pneumococcal injection site.									Y	10/24/2005	10/25/2005	1		PUB	PUB	Insulin	NONE	History of catex sensitivity, Diabetes			1						1	Discomfort; Hypokinesia; Injection site oedema; Injection site reaction; Pain; Rash macular	FLU3~SANOFI PASTEUR~U1846AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0967P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247687	11/17/2005	VA	48.0	47		F	11/14/2005	Pt reports that by 11/11/2005 in the evening hours she had area patch that was warm to the touch about 7cm long a small orange size per pt. By Saturday 11/12/2005, pat reported redness had spread down her arm further, was very sensitive to the touch and had a darker center right around where shot was given. Pt is here on 11/14/2005 and arm is still red. Almost circumferential about 15-30cm in size. Given PRX of Keflex 500 mg QID x 7 days on 11/14/2005. The redness was around where pt was given Pneumovax vaccine.									Y	11/11/2005	11/11/2005	0	NONE	PVT	OTH	Singulair, Calcium carbonate, Effexor XR, Amitriptyline, Benicar	NONE	Hypertension, Asthma, GERD, depression, allergic rhinitis, allergies: HCTZ, ACE inhibitors, Trazodone, Lisinopril.			1						1	Erythema; Feeling hot; Hyperaesthesia; Injection site reaction; Skin discolouration	FLU3~SANOFI PASTEUR~U1825FA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0741R~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247712	11/17/2005	IN	7.0	7		F		Employee states after receiving flu shot at 11:30 am 11/15/05 she felt fine until 6pm or 7pm. Then she ached all over and had trouble exhaling. This lasted 1 hr. She took a sleeping pill and when she woke, she was fine.									Y	11/15/2005	11/15/2005	0		UNK	OTH	Ortho Tri-Cyclen	NONE	NONE			1						1	Dyspnoea; Pain	FLU3~SANOFI PASTEUR~U1764AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247716	11/17/2005	SC	53.0	53		M	11/17/2005	Patient called on 11/3 in the AM reporting redness, inflammation and warmth to touch in RA at site of PPV23 injection.  Admits never received PPV23 before.  Instructed by RN to come to the health department for assessment or make an appointment with private MD.  RN did not see or assess patient.				Y					Y	11/01/2005	11/02/2005	1	NONE	UNK	UNK	Tenormin, Plavix, Vitorin, Niaspan	NONE	NONE		SC0524	1						1	Injection site erythema; Injection site hypersensitivity; Injection site inflammation	FLU3~SANOFI PASTEUR~U1903AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1040P~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247717	11/17/2005	SC	69.0	69		F	11/17/2005	11/9/2005:  Patient states about 6 hours after receiving injection she began hurting under her arm and having nausea.  Took Darvocet for pain.  Was unable to sleep.  Still complained of soreness and nausea today.  Denies arm being red or hot to the touch.									Y	11/08/2005	11/08/2005	0		UNK	UNK	Synthroid, Latrell, Premarin, Nexium, Inderal	NONE	Mitral valve prolapse; diverticulitis	childs; fever~Influenza (Seasonal) (Fluzone)~2~5.70~In Sibling|~Influenza (Seasonal) (Fluzone)~~0.00~In Sibling	SC0525	1						1	Insomnia; Nausea; Pain	FLU3~SANOFI PASTEUR~U1903AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1040P~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247718	11/17/2005	MS	13.0	13		M	11/17/2005	rash at the site of injection  axillary lymph node swelling									Y	11/11/2005	11/11/2005	0		UNK	PVT						1						1	Injection site rash; Lymphadenopathy	FLU3~SANOFI PASTEUR~u1775aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247719	11/17/2005	IA	11.0	11		F	11/17/2005	Focal seizure  2 hours after vaccine given... partial seizure 24 hours after give									Y	11/14/2005	11/14/2005	0		UNK	UNK	Tegritol	none	Cerebal Palsy.. seizure disorder	Fever~DTaP + Hib (no brand name)~~0.30~In Patient		1						1	Convulsion	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247720	11/17/2005	PA	57.0	57		F	11/17/2005	The Flu Shot was given on 11/9/05 @ 10:00 AM in the Left Deltoid muscle without difficulty. That evening client reported she had ichy skin in left ear lobe and left side of neck under the chin. Then the next day awaken with a swollen left earlobe and non-raised rash in left nesk area the size of a 50 cent piece and complains of itchyness in this area.I administered 25 mg of Benadryl and sent her back to work. Two hours later I called her to see how she was doing and she informed me she was going home because she was to tired to work. That night she reports that the entire left ear became swoollen and ichy. Her rash also got larger. She applied a cream to the ear and took a motrin tablet her friend gave her. She does not remember what the name of the cream was.									Y	11/09/2005				UNK	UNK	None	None				1						1	Fatigue; Pruritus; Rash; Swelling	FLU3~SANOFI PASTEUR~U1826AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247721	11/17/2005	VA	68.0	68		F	11/17/2005	Patfient received the PPV23 vaccine on 11/14/05 sc left arm;  site became extremely red and painful the evening of 11/16/05.  Pt says she put ice on it yesterday.  This is patients second pneumococcal vaccine.  The first was given greater than 5 years ago.  The flu shot was also given at the same time IM, left arm also, as patient had surgery in the right arm.  Patient not in any acute distress.  She was concerned about the redness since she has never had any problems from receiving the flu shot every year.  She will continue cool compresses, take alleve as needed.  Recommended to call her PCP if redness worsens.									U	11/14/2005	11/16/2005	2		UNK	UNK	Coazzar, Clarinex	none	no allergies			1						1	Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~u1831ab~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0748p~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247722	11/17/2005	MO	2.0	2	.8	M	11/17/2005	Approximately 24 hours after receiving flu vaccine patient had a seizure lasting 20 seizures.  It was a full tonic-clonic seizure.  At the hospital the Pediatrician noticed a rash on patient's trunk and hand (I observed this also).  She did a throat culture for strep and stated that this was not an adverse reaction to the vaccine.  Additionally a resident at the ER indicated it was not an adverse reaction to the vaccine and the patient's pediatrician stated it was not an expected reaction but that it would be reported to FDA/CDC.				Y					Y	11/01/2005	11/02/2005	1	throat culture for strep during ER visit EEG appeared abnormal at follow-up physician visit MRI on 2nd follow-up physician visit	UNK	UNK		Patient had croup	patient is treated with Zyrtec for seasonal allergies			1						1	Convulsion; Rash; Convulsion	FLUX~UNKNOWN MANUFACTURER~~UNK~~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1805AA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0247723	11/17/2005	AZ	72.0	72		F	11/17/2005	Sept.23: Received vaccine. Sept.25: Headache, lethargy. Oct. 17: Had complete eye examination. Recommended seeing opthalmologist. Oct. 29: Woke to double vision. Nov. 3:  Acupuncture treatment for headache and impaired vision. Fever of 103 deg. by 6:00pm. Drank ginger ale to reduce fever. Headache gone 7:00pm fever broke. Nov. 5: Called primary care doctor, DO to report above. Spoke with Dr. Told to go to Emergency Room for an MRI. Followed inst. Had MRI at med. center, with report that their were no tumors or evidence of stroke. Followed up with appt. at primary care. Nov. 7: Talked with Dr. in his office. Told him I thought the double vision was an adverse reaction to a flu shot. (Non converm.) Nov.15: Appt.with Dr., Opthalmologist Spec. glacoma and cataracts. Diagnosis: Sixth nerve palsy. No evidence: glaucoma/cataracts. Follow-ups Dec. 7 & Feb.21, '06. Nov17: Follow-up treatment w/ acupuncturist. Nov18: Reading vision returning-Dbl/6' distance.				Y					N	09/23/2005			Medical center; Opthalmologist	UNK	UNK						1						1	Headache; Lethargy; Pyrexia; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0247724	11/17/2005	CO	4.0	4		M	11/17/2005	Phone call from mother, stating that child had a flu shot on 11/15/05 at about 9am, the next morning she noted child had a rash on his cheek and ear.  The rash now covers his face.  Child may have a slight fever or 99 (mother states she is having problems with her thermomater). Denies any other symptoms.   Researched Fluzone package insert, and discussed with manufacturer.  Informed mother that we would report as a possible vaccine reaction, but she should monitor the child for increasing symptoms and if she has any concerns, he should see his pediatrian. Also advised her to keep child home from daycare.									U	11/15/2005	11/16/2005	1		UNK	UNK						1						1	Pyrexia; Rash	FLU3~SANOFI PASTEUR~U1746AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247725	11/17/2005	VA	48.0	48		F	11/17/2005	Generalized puritis with 3.5 x 3.5 erythema and warmth at injection site.  No SOB or difficulty breathing.  Occured within 20 minutes of injection				Y					Y	11/16/2005	11/16/2005	0		UNK	UNK			Allergic to Dilaudid, Phenergan and Sulfa.  Has had similiar reactions to tetanus and PPD.			1						1	Injection site erythema; Injection site hypersensitivity; Pruritus; Similar reaction on previous exposure to drug	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62445~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0247726	11/17/2005	CA	39.0	39		F	11/17/2005	approx 15 minutes after flu shot administration I initially felt increasingly disorientated, brief nausea and then I went blind. I felt as if I was separated from my body! I was semi-conscious and totally paralysed (lucky I was sitting down). I struggled for air as felt extremely hot and sweat. I was completely recovered after 15 minutes! I thought I was having an allergic reaction which in turn made me panic so I'm not sure as to whether or not this reaction was a panic attack or an alegic reaction as the symptoms are similar. I need to know so that I don't receive the flu shot again if I am allergic.									Y	11/16/2005	11/16/2005	0	None	UNK	UNK	None	None	erythimicin			1						1	Blindness; Depressed level of consciousness; Disorientation; Dissociation; Dyspnoea; Hot flush; Hyperhidrosis; Hypersensitivity; Nausea; Panic reaction; Paralysis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247727	11/17/2005	MA	57.0	57		F	11/17/2005	Approximately 15 minutes following immunization, this recipient complained of itching and began developing hives. Two 50 mgm. doses of Benadryl were given 10 minutes apart and her symptoms progressed. Anambulance then transported her to the Emergency Department. She was treated, evaluated for a period of time and released home in good condition.				Y					Y	11/17/2005	11/17/2005	0		UNK	UNK		No	None Known			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1830AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247728	11/17/2005	MA	54.0	54		F	11/17/2005	She came to the Occupational health Department shortly after receiving the Flu shot, complaining of dizziness, feeling lightheaded and cold. She was treated and released with no further signs and symptoms.				Y					Y	11/10/2005	11/10/2005	0		UNK	UNK	no	No	No			1						1	Dizziness; Feeling cold	FLU3~SANOFI PASTEUR~1826AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247729	11/17/2005	NY	15.0	15		M	11/17/2005	16 TO 17 HRS AFTER VACCINES GIVEN PATIENT DEVELOPED FEVERS, MYALGIS, STIFF NECK, & HEADACHE. PATIENT TREATED SYMPTOMATICALLY AND SYMPTOMS RESOLVED IN 48 HRS.				Y					Y	10/03/2005	10/04/2005	1		UNK	UNK	ZOLOFT 50MG QHS ZYRTEC 10MG QD PIROXICAM 20MG QD PRN KNEE PAIN		OBCESSIVE COMPULSIVE DISORDER TURRET'S SYNDROME DEPRESSION PERENNIAL ALLERGIES OSGOOD-SCLATTER DISEASE EXERCISE INDUCED ASTHMA			1						1	Headache; Musculoskeletal stiffness; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1794AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1640AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0247732	11/17/2005	NC	52.0	51		F	11/17/2005	Flu vaccine administered 11/15/05 9:30 am. About 2-3 hours later states she started feeling hot/itchy with facial and chest flushing. Also scratchy throat. First time ever to receive a flu vaccine. Took Benadryl 3 times. Symptoms have decreased. Now only has redness on one facial cheek. No itching. Telephone call to employee to evaluate symptoms States she has greatly improved. No further itching and redness decreased to one side of face only. Resolving facial redness and itchiness post flu vaccine. To notify her PMD and update EHM if symptoms return. Employee reported to EHM that she had developed facial and chest redness and a feeling itchy about 2-3 hours after receiving a flu vaccine on 11/15/2005 around 9:30 am here at the main clinic. Went home and took 2 Benadryl which started to relieve s/s and a third Benadryl before bedtime. Continue to have facial flushing and achy feeling today, so came to EHM for evaluation. Hoc Anaphylaxis to medications. Known allergies to cortisone, morphine and penicillin. Hx of essential tremor treated with Inderal. OTC meds included vitamin C and multivitamin. Facial and chest redness remains present BP 122/72, pulse 60, lungs clear. Possible reaction to flu vaccine. Benadryl 25mg tax times 1 given now and one dose for later in the day. After returned to regular work. Vaers form completed. Will reassess on 11/17/05. Instructed if s/s worsen to notify her MD. Recommended no future flu shots Verbalized understanding.									N	11/15/2005	11/15/2005	0		OTH	PVT	Inderal;Vit C/Multivitamin	NONE	Allergy - Penicillin,morphine;has essential tremor - takes Inderal			1						1	Erythema; Feeling hot; Flushing; Pain; Pharyngolaryngeal pain; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA120AA~1~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0247733	11/17/2005	NY	1.57	1	.6	M	11/11/2005	Left thigh w/diffuse redness									Y	10/24/2005	11/01/2005	8		PVT	PVT		NONE				1						1	Erythema	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14006AA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1765CA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247734	11/17/2005	MO	4.0	4		M	11/17/2005	Mom called and said her son was aching like an old man after receiving the flu shot on 11-15-2005. She said he won't hardly walk, his neck and ears hurt, and he's crying. Mom took him to the doctor. Dr drew  labs as noted below. Dr thought it was an immune system response. Tx with ibuprofen was done and child was okay after noon on Wednesday 11/16/05. Tx resolved itself.				Y					Y	11/15/2005	11/15/2005	0	CBC ok; other labs -ok	PUB	PUB		NONE	NONE			1						1	Crying; Difficulty in walking; Ear pain; Neck pain; Pain	FLU3~SANOFI PASTEUR~U1915AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247740	11/17/2005	CA	39.0	39		F	11/17/2005	two severe episodes of hives									Y	10/04/2005	10/05/2005	1		UNK	UNK	none	no	no			1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0247744	11/17/2005	HI	7.0	7		F	11/17/2005	C/O Myalgia, headache, fever 102 which started around 7:00pm the day the shot was given.										11/16/2005	11/16/2005	0	None	UNK	UNK		None	None			1						1	Headache; Myalgia; Pyrexia	FLU3~PFIZER\WYETH~U1754AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0247747	11/17/2005	NY	51.0	51		F	11/17/2005	I received the flu shot at around 10:30 am. At about 2:30 pm I started to feel my eyes were bothering me.  My co-worker told me my eyes were very red.  My throat was also begining to get sore.  On the train ride to my therapy I began to feel worse.  At the Doctors office I my mouth began to feel swollen and I had the chills, and started to cough.  By the time I got home my body ached, my eyes and mouth were swollen and my head hurt.  I drank some tea with lemon and honey, took 2 Aleves, had some lipton chicken soup and went to bed.  Next day Wednesday November 16, stayed home and drank some more tea, had some soup.  By the afternoon I started to feel alot better.  I didn't go see my Dr.  I returned to work on Thursday and my co-workers told me to call the 800 number to let them know of my reaction from the flu shot.									Y	11/15/2005	11/17/2005	2	none	UNK	UNK						1						1	Chills; Cough; Eye swelling; Headache; Ocular hyperaemia; Pain; Pharyngolaryngeal pain; Swelling face	FLU3~SANOFI PASTEUR~U1819AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247748	11/17/2005	OR	55.0	55		F	11/17/2005	about 20 minutes after getting my flu and phnemonia shot, I experienced numbness on the left side of my face.  My eye and cheek are totally numb, and a little numbness on the right cheek and eye.  Also bad headache, and nausea.				Y					U	11/17/2005			Dr.'s office to Urgent care for a ekg, to emergency room for cat scan	OTH	OTH		none			OR200537	1						1	Facial palsy; Headache; Hypoaesthesia; Nausea	FLU3~AVENTIS PASTEUR~U1868AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1047P~1~UN~LA~PNEUMO (PNEUMOVAX)~1|UNK~UNKNOWN MANUFACTURER~~UNK~UN~UN~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0247749	11/17/2005	CA	15.0	15		F	11/17/2005	Heaviness in foot, both lower extremities weakness and tingling,ataxia. Dx'D mild Guillain Barre Discharge summary states headache.  Medical record states dizziness, nausea					Y	1			U	11/12/2005	11/12/2005	0	EMG C/W Guillain Barre, LP CSF nl protein/glucose, 2 WBC Discharge summary statres abnormal lab results.	OTH	UNK	NONE					1						1	Dizziness; Guillain-Barre syndrome; Headache; Laboratory test abnormal; Nausea; Paraesthesia; Sensation of heaviness	FLU3~AVENTIS PASTEUR~U1871BA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0247750	11/18/2005	AZ	81.0	81		M	11/18/2005	While watching wife had severe allergic Rxn to flu shot ( and 10 min after her flu shot) Pt vasovagal syncope on chair and progressed  to full arrest.  No additional information from Medical Record rec'd 01/25/2006/sr	Y	11/17/2005	Y	Y					N	11/17/2005	11/17/2005	0		PVT	PVT	Prazosin 2mg;Ditropan XL; 10mg;Cozaar 50mg;Namenda 10mg;Zoloft 50mg;Diovan 160		No allergies, Alzheimer's, HTN, increased Prostate Specific Antigen, asbestos exposure, cardiomegaly, high cholesterol, anemia, lung asbestosis.			1						1	Anaphylactic reaction; Cardiac arrest; Hypersensitivity; Syncope; Syncope vasovagal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61501~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0247753	11/18/2005	NY	40.0			F	11/15/2005	Initial report received on Nov 11 2005 from a health care professional.  A 40 year old female patient (date for birth not reported) with an unknown medical history received an influenza vaccine on either 11/02/2005 or 11/03/2005. The manufacturer, route, site and lot number of the vaccine was not reported. Per the reporter the patient was diagnosed with encephalomyelitis of undetermined etiology (date of diagnosis not reported). The patient's recovery status is reported as unknown at the time of this report.				Y										OTH	OTH					200502428	1						1	Encephalitis	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0247754	11/18/2005	WA	48.0	47		M	11/15/2005	Seriousness criteria Other medically significant (OMIC). A 47 year old male with a medical history of plantar warts received an intramuscular right deltoid injection of Fluzone SV 2005 2006. lot number U1865AA, on Oct 24 2005. The patient maintained a log of his adverse events. One day later, he developed tail bone swelling. On Oct 26 2005, he experienced lip swelling. On Oct 27 2005, the back of his head was swollen, and he had welts in his hairline, beard and lips. The patient experienced shortness of breath. On Oct 30 2005, he developed tightness in his right thigh. On Oct 31 2005. he developed a cough, sore throat and swollen glands. On Nov 2 2005, the arches of his feet were painful, both hands were swollen, his palms had welts, and he could hardly walk. He was examined by a physician on Nov 2 2005 and prescribed extra strength ibuprofen and allergra. At the time of this report, he is still not well. The patient had no illness at the time of vaccination, and other medications were not reported. The patient had received three previous dosed of Fluzone. At the time of this report, the patient had not recovered.				Y					N	10/24/2005	10/25/2005	1		UNK	UNK			The patient has a history of plantar warts.		200502366	1						1	Bone disorder; Cough; Difficulty in walking; Dyspnoea; Face oedema; Lymphadenopathy; Malaise; Muscle disorder; Oedema; Pharyngolaryngeal pain; Urticaria	FLU3~SANOFI PASTEUR~U1865AA~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247755	11/18/2005		85.0			F		A report was received from a non healthcare professional  on Nov 10 2005, concerning a female vaccinee aged approximately 85 years old. The vaccine's medical history or concomitant medications was unknown by the reporter. On an unknown date, the vaccine received Fluvirin (batch 61503). On an unknown date the vaccinee developed localized cellulitis and swelling at the injection site. The vaccinee is currently hospitalised and her symptoms are persisting. Follow up information will be sought.					Y	0								UNK	UNK	Concomitant drugs not reported.				CVOX200600155	1						1	Cellulitis; Injection site oedema; Injection site reaction	FLU3~EVANS VACCINES~61503~UNK~~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0247758	11/18/2005		85.0			M		A report was received from a non healthcare professional on Nov 10 2005, concerning a male vaccinee aged approximately 85 years old. The vaccine's medical history or concomitant medications was unknown by the reporter. On an unknown date, the vaccinee received Fluvirin (Batch 61503). On an unknown date the vaccinee developed localized cellulitis and swelling at the injection site. The vaccinee is currently hospitalised and his symptoms are persisting. Follow up information will be sought.					Y	0								UNK	UNK	Concomitant drugs not reported				CVOX200500154	1						1	Cellulitis; Injection site oedema; Injection site reaction	FLU3~EVANS VACCINES~61503~UNK~~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0247759	11/18/2005	AZ	82.0	81		F	11/18/2005	Approx 10 mins after Fluvirin shot and 20 mins after Kenalog Marcaine left shoulder intra articular injection. Pt had SOB,hive like rash,itching, syncope and near loss of consciousness, given O2, IV fluids, Benadryl, SQ epi, Solu Medrol, shoulder pain, decreased range of motion. Pain keeping PT awake at night. Prior to administration pt was lightheaded an slumped to floor. Pt was layed on floor, Pt semi alert no LOC. Small amount of clean emesis, O2 given by facemask, then Benadryl and EPI given. Then Pt lifted to wheel chair taken to BM9. IV was started O2 sat 93. Monitor put on. Low BP noted PVC and Decreased HR if sat up. So Pt was maintain in supine position 600-700 cc IV saline Solu, No wheezing. mild decreased in rash. Given Solumedrol and transported to ER in ambulance. A & O x3 and talking.			Y	Y					Y	11/17/2005	11/17/2005	0		PVT	PVT	Norvasc 10 mg;Levothynxine 25;Lexapro10mg;Dopral XL 100;Lasix 20;Avapro;Trazodone 50mg;Nexium	Shoulder arthritis	Macrobid, hypertension, Arteriosclerotic peripheral vascular disease. endometriosis, CVA x 3, Syncope, Low thyroid, High cholesterol, Degenerative disk disease. Osteo arthritis left shoulder.			1						1	Blood pressure decreased; Depressed level of consciousness; Dizziness; Dyspnoea; Heart rate irregular; Hypersensitivity; Hypoxia; Joint range of motion decreased; Pain; Rash; Sleep disorder; Syncope; Urticaria; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61501~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening	Influenza
0247760	11/18/2005	VA	0.78	0	.8	M	11/17/2005	Mom describes about 2 1/2 hours after vaccination child with problems breathing, whistling in throat, shaking, trembling, crying a lot. Both legs hot. No color change or swelling at site per mom. Seen in ER discharged 9am 11/09 still fussy. Decreased sleep, crying, very sweaty, vomiting, flaccid, limp went to clinic hospitalized.  Information received from parents on the 60 day follow-up states that parent reports child is not as active as prior to vaccintions. Father feels child speaks slowly, sleeps more. Doctor has told parents that increase sleeping is normal.				Y	Y	4			U	11/08/2005	11/08/2005	0		PUB	PUB	NONE	Stuffy nose, Phlegm in throat				1						1	Agitation; Crying; Dyspnoea; Feeling hot; Hyperhidrosis; Hypersomnia; Hypotonia; Insomnia; Irritability; Speech disorder; Tremor; Vomiting; Wheezing	DTAP~SANOFI PASTEUR~AC21A021AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1746AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SANOFI PASTEUR~AC21A021AA~4~IM~LL~HEP B (GENHEVAC B)~1|HIBV~SANOFI PASTEUR~UE766AA~4~IM~RL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~AC21A021AA~4~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~A98341A~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0247762	11/18/2005	PA	1.97	1	1	M	11/14/2005	Pt received Influenza vaccine 11/01/2005, pt had fevers and then suffered a febrile seizure 11/3/2005, requiring admission to pediatric inpatient unit. Evaluation revealed leukopenia. Information from medical records states pharyngitis, hypothermia. msv Medical records state vomiting. msv				Y	Y	2			Y	11/01/2005	11/02/2005	1	WBC 1900 33% neutrophils, 48% lymphocytes, 8% basophils Information from Medical records state leukopenia, hyperglycemia. msv Medical records state abnormal platletts. msv	PVT	PVT	NONE					1						1	Basophilia; Convulsion; Hyperglycaemia; Hypothermia; Leukopenia; Lymphopenia; Neutropenia; Pharyngitis; Platelet disorder; Pyrexia; Vomiting; White blood cell count decreased	FLU3~SANOFI PASTEUR~U1787DA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0247763	11/18/2005	NV	65.0	65		F	11/12/2005	Left upper arm with wide red area below injection site. Measures about 7 x 7 cm spreading down to elbow then medial down lower arm about 1cm below her elbow. T 98.2, P 96, R 18, BP 151/91. Area is warm to touch with heat radiating from red area.  12/15/05 Review of D/C summary indicates final diagnosis of cellulitis L arm (site of pneumococcal vaccine). Arm was described as erythematous, swollen and uncomfortable. Treated with Timentin IV for 24 hours. She did develop some wheezing overnight in hospital and attributed it to the new carpet being put down near her room. She was treated with nebulizer and Solu-Medrol. She was d/c on PO prednisone in 3 tapered doses and albuterol inhaler two puffs qid.				Y	Y	1			Y	11/10/2005	11/11/2005	1	3/6/09: CBC 11/12/05 (see attached)	PVT	OTH	3/6/09:PRN, ADVAIR; SINGULAIR; anti-hypertensive hormones (estrogen)	None	12/15/05 - Per review of d/c summary preexisting conditions include HBP & asthma.  3/6/09: Allergies			1						1	Cellulitis; Condition aggravated; Erythema; Full blood count; Injection site erythema; Injection site warmth; Skin warm; Swelling	FLU3~SANOFI PASTEUR~U1865FA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0604R~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0247765	11/18/2005	FL	55.0	55		F		Severe localized inflammatory signs from left shoulder to elbow and generalized malaise, shaking, chills, fever, nausea, vomiting symptoms started 7 hours after vaccination.									Y	11/15/2005	11/15/2005	0		OTH	OTH		NONE	NONE			1						1	Chills; Inflammation; Malaise; Nausea; Pyrexia; Tremor; Vomiting	FLU3~SANOFI PASTEUR~U1872AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0607R~UNK~SC~LL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247766	11/18/2005	WA	25.0	25		F	11/18/2005	I experienced itching, burning, and swelling at site of flu shot right deltoid. Redness measuring 6 cm across and 4cm down. Received shot on 11/14/2005 had some arm tenderness on 11/15/05 and noticed itching, burning, and swelling morning of 11/16/05.				Y					U	11/14/2005	11/15/2005	1	none	PVT	PUB	Minocycline, BCP (Apre)	NONE	Allergic to citric Acid			1						1	Erythema; Injection site oedema; Pruritus; Skin burning sensation; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61501~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0247767	11/18/2005	WA	49.0	48		F	11/18/2005	Nauseated that evening. 11/17 weak, nausea, myalgia, headache, 11/18 weak, diarrhea, afebrile, no treatment.									Y	11/16/2005	11/16/2005	0	NONE	PVT	PUB			Polymyosipistis, Diabetes			1						1	Asthenia; Diarrhoea; Headache; Myalgia; Nausea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61501~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0247768	11/18/2005	CA	2.0	2	.4	M	11/18/2005	Left upper arm became red, warm, firm and swollen, tender to touch on 11/16/2005. Treated with ice, cold compresses, improving.				Y					Y	11/15/2005	11/16/2005	1	NONE	PUB	PUB		NONE	Asthma			1						1	Erythema; Feeling hot; Oedema; Tenderness	FLU3~SANOFI PASTEUR~U176EA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247769	11/18/2005	OR	23.0			F	11/20/2005	Chills, hot, cold, left upper arm stiffness, erythema, hot to touch, no parasthesia, burning sensation. Progressive SX over 24 hours.									U					MIL	MIL	Motrin		Allergic to erythromycin			1						1	Chills; Erythema; Feeling cold; Feeling hot; Hot flush; Musculoskeletal stiffness; Skin burning sensation	FLU3~SANOFI PASTEUR~U1916AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247770	11/18/2005	WY	7.0	7		F	11/15/2005	Within 5 minutes, patient's right arm from above elbow to top of shoulder became erythematous and itchy. The redness and itching progressed into her neck and her throat became itchy. Benadryl 25mg was given at 5 minutes. After 45 minutes, patient's arm remained red, but itching was gone.									Y	11/14/2005	11/14/2005	0	NONE	PVT	PVT	NONE	NONE	Allergies (environmental); Skin sensitivities			1						1	Erythema; Pruritus	FLU3~SANOFI PASTEUR~U1761AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247771	11/18/2005	RI	53.0	52		F	11/11/2005	Within 1 hour, employee started to feel itchy. Pain at injection site. Rash started with small open areas. Prednisone to start on 11/12/05. MRI to be done to assess nerve damage. Left upper arm slightly swollen. Feels squeezing type discomfort. No pain medication needed.				Y					N	10/12/2005	10/12/2005	0	CBC; Sed Rate; ANA to be done.	PVT	PVT	Ambien; Cipro BID	NONE	Heart murmur from childhood; Positive Lyme titer			1						1	Discomfort; Injection site pain; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U1747AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247772	11/18/2005	CO	66.0	65		F	11/12/2005	Feverish, aching muscles - particularly arm, back and neck; weak. Red, swollen, sore upper arm where shots given. Could only sleep for 24-48 hours.									Y	10/19/2005	10/19/2005	0	NONE	OTH	PUB	NONE	NONE	NONE			1						1	Asthenia; Erythema; Myalgia; Pyrexia; Sleep disorder; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247773	11/18/2005	NY	4.0	4		F	11/16/2005	Edema/erythema of entire deltoid area where vaccine administered.									Y	11/10/2005	11/11/2005	1	NONE	PVT	PUB		NONE	Asthma; Rhinitis			1						1	Erythema; Oedema	FLU3~SANOFI PASTEUR~U1863AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247774	11/18/2005	WA	1.3	1	.3	F	11/18/2005	Immediate swelling at site where DTaP given. Benadryl tsp PO in the first few minutes.									Y	11/18/2005	11/18/2005	0		PVT	PUB	NONE	Swelling at site	NONE			1						1	Injection site swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B006BA~4~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1743NA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0422R~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0247775	11/18/2005	IA	51.0	51		F	11/16/2005	Approximately 8-10 hours after vaccine given, patient became ill: nausea/vomiting/diarrhea - duration 24 hours. Unsure if vaccine related or just unrelated illness.									Y	10/27/2005	10/28/2005	1	NONE	PUB	PVT	Welbutrin	NONE	NONE			1						1	Diarrhoea; Malaise; Nausea; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA147CA~UNK~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0247776	11/18/2005	VA	51.0	51		F	11/18/2005	Patient received vaccine on 11/15/05 and noticed a rash on 11/16/05; slightly raised, reddened rash bilaterally on lower extremities (from mid-calf to ankle). Neck and forearms were itchy without visible rash noted. Patient felt achy and voice was hoarse on the night of 11/15/05. 11/18/05 Still has rash on lower extremities.									N	11/15/2005	11/16/2005	1		OTH	PVT	Crestor; Avandia; Metamorphin; Lisinopril; ASA; Amaril	NONE	Allergic to PCN; Patient is diabetic; High cholesterol			1						1	Dysphonia; Pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~U1904AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247777	11/18/2005	MT	37.0	36		F	11/15/2005	Arm started hurting at injection site about 2 hours after administered. Next day, my whole arm hurt, injection site was swollen, red, and hot. 2 days after injection, arm was really painful, red, swollen and injection site was hot to touch, developed fever of 102.4. Tylenol and ice packs; fever broke at about 1 AM; arm still painful.									Y	11/10/2005	11/10/2005	0	NONE	PUB	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U1868AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247778	11/18/2005	MS	41.0	41		F	11/12/2005	Red wheal 24 hours after vaccine was given. OTC Benadryl 50mg Q12 hours for 48 hours. Benadryl and Decadron IM at doctors office.				Y					Y	11/03/2005	11/04/2005	1	NONE	PUB	UNK	Glucovance 5/500	Diabetes	Allergies - Levaquin			1						1	Erythema; Urticaria	FLU3~SANOFI PASTEUR~~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247780	11/18/2005	NY	3.0	2	.6	M	11/14/2005	Acute onset of severe and persistent stuttering within 24 hours of vaccination.									U	11/11/2005	11/12/2005	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Dysphemia	FLU3~SANOFI PASTEUR~U1854AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247781	11/18/2005	SC	37.0	37		F	11/14/2005	Body aches/muscle cramps - severe chills, high fever (101F), headaches, shakes, stomach cramps. Lasting about 6 hours then just achy, tired for 24 to 48 hours.									Y	11/07/2005	11/07/2005	0		OTH	PVT	NONE	Sinusitis (no fever) not severe	NONE			1						1	Abdominal pain upper; Headache; Muscle spasms; Pain; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247782	11/18/2005	IA	46.0	46		F	11/09/2005	11:10am- nasal congestion with drainage. Denies SOB or tightness of throat. 11:20am - reports throat closing in. Constant throat clearing. Face  and neck red. 911 called. 11:24 - epinephrine 0.3 mL given left arm subq. pulse =80, R=34. 11:28 ambulance to ER.				Y					Y	11/07/2005	11/07/2005	0	Acute allergic reaction	OTH	PVT	None	NO	Allergy to PCN- red rash body			1						1	Erythema; Hypersensitivity; Nasal congestion; Rhinorrhoea; Throat tightness	FLU3~SANOFI PASTEUR~U1830AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247783	11/18/2005	NY	67.0	67		M	12/14/2005	Swelling and soreness at area of vaccination. Swelling continued to spread from shoulder to wrist. Finally had to visit emergency room where cellulitis was diagnosed by Dr. and 10 days of antibiotics (Cephalexin) was prescribed. Doesn't have manufacturer or lot # info requested on ack letter.				Y					Y	10/28/2005	10/28/2005	0	Problem developed in right arm where pneumonia vaccine was administered.	PVT	OTH	Ibuprofen, Lisinopril		Blood pressure treated with Lisinopril			1						1	Cellulitis; Injection site pain; Injection site reaction; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0247784	11/18/2005	RI	67.0	66		F	11/08/2005	No signs, symptoms of local reaction at site. At 6pm of day of injection client was on a treadmill and began to have palpitations. On 11/05 at 12PM client began to have palpitations again, dizzy, heaviness in chest, client advised to see MD with these symptoms ASAP.									U	11/04/2005	11/04/2005	0	none yet	PUB	PVT		None known	None known			1						1	Chest pain; Dizziness; Palpitations	FLU3~SANOFI PASTEUR~U1778AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247785	11/18/2005	NY	70.0	69		F	11/15/2005	P stated was given both flu and pneumo vac. in left upper arm. Arm swelled and became very reddened with red streaks per patient. went to ER.				Y					Y	11/10/2005	11/10/2005	0		PUB	PUB						1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema	FLU3~SANOFI PASTEUR~U1778AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0691P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247786	11/18/2005	CA	0.53	0	.5	M	11/17/2005	Day says baby had a 5 minute episode of blank staring, unresponsiveness, w/mild floppiness, and pale discoloration of face, which occurred about 12 hrs after immunizations, plus fever 100.8 - 102F, baby now well and asymptomatic.				Y					Y	11/16/2005	11/17/2005	1	N/A	PVT	PVT		NONE	NONE			1						1	Coma; Hypotonia; Pallor; Pyrexia; Skin discolouration; Staring	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B011BA~3~IM~~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1754AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE682AA~3~IM~~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A98341K~3~IM~~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0247787	11/18/2005	OK	40.0	39		F	11/14/2005	AT 14:40 LPN notified by patient that she had spoken with co worker and believed she was having an allergic reaction R/T bumps on face and arms.				Y					Y	11/11/2005	11/11/2005	0	NONE	OTH	PVT		NONE				1						1	Hypersensitivity; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61503~4~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0247788	11/18/2005	RI	53.0	53		F	11/07/2005	Client stated that she felt no pain at the time of the injection into the left deltoid. The following day she reported some muscular soreness. During that night, about 36 hours after the injection, she awoke with severe pain in left arm which totally interfered with sleep. The pain was radiating down the arm to the hand and she had difficulty raising the arm. That day, 48 hours after injection, she noted slight redness at the site and swelling of the left arm as well as under the arm near the axilla. Three days out she still reported tingling. She treated herself with moist heat and OTC pain reliever. By day 4, she consulted a physician but was having improvement in function and diminishing pain.				Y					U	11/03/2005	11/05/2005	2	To MD, to Neurologist, x-rays	OTH	PVT	Unknown	None known	None known			1						1	Injection site erythema; Injection site pain; Injection site swelling; Joint range of motion decreased; Myalgia	FLU3~SANOFI PASTEUR~U1762AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247789	11/18/2005	WI	23.0	22		M	11/14/2005	Rash torso, ring like rash left arm at site I&D at site. Given Benadryl and Minocycline. Possible erythema multiforme post smallpox vaccination.									Y	11/04/2005	11/13/2005	9		MIL	MIL	None	None	None			1						1	Erythema multiforme; Rash	ANTH~EMERGENT BIOSOLUTIONS~fav107~1~SC~~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1911AA~5~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020072~1~~~SMALLPOX (DRYVAX)~1	USA		Influenza
0247790	11/18/2005	NY	54.0	54		M	11/06/2005	Numbness of left foot, skin on toes, instep, medial aspect of foot and arch, extending up shin about half way. Also rapid burning sensation of skin, itching, (severe) on skin on chest and back.									U	11/05/2005	11/05/2005	0	NONE	MIL	MIL	NONE	Paresthesia medial aspect left foot	NONE			1						1	Hypoaesthesia; Pruritus; Thermal burn	FLU3~SANOFI PASTEUR~U1869AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~SANOFI PASTEUR~Y0794~4~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0247791	11/18/2005	FL	49.0	48		M	11/14/2005	11/9/05 vaccine given, 11/12/05 in AM felt full heavy ache feeling in right arm, became more intense throughout the day. On 11/13/05 and 11/14/05 when reported the pain was transient and less intense. Site verified that it was given in the deltoid. States no point tenderness.									Y	11/09/2005	11/12/2005	3	NONE	PVT	UNK		NONE	Denies	sore arm~Tetanus Toxoid (no brand name)~~0.00~In Patient		1						1	Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA147CA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0247792	11/18/2005	GA	66.0	65		F	11/15/2005	Received pneumonia vaccine on 11/14/05 in right arm at 11:30am. States around 1:30pm start having pain. Discovered rash around 8:30pm felt a raised area. Had been hurting all night. In today at health dept. Has reddened rash right arm with some warm and swelling.				Y					N	11/14/2005	11/14/2005	0		UNK	UNK	Norvasc  10mg daily, Zoloft 50mg daily, Darvocet-N 100 prn	No	Sulfur, Codeine, Bactrim			1						1	Injection site pain; Injection site swelling; Injection site warmth; Rash erythematous	FLU3~SANOFI PASTEUR~U1936AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247793	11/18/2005	PA	77.0	77		F	10/25/2005	Swelling, tenderness right upper arm.				Y					Y	10/24/2005	10/24/2005	0		PVT	UNK		NONE				1						1	Injection site swelling; Tenderness	FLU3~SANOFI PASTEUR~U1794AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0607R~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247794	11/18/2005	AL	39.0	38		F	11/07/2005	Right upper arm, swollen, red and warm to touch. State had a Flu shot yesterday sent to see MD for evaluation. Unable to get vaccine lot # today. Phone call and was told  patient had pneumonia shot right arm.				Y					Y	11/03/2005	11/04/2005	1		PUB	PUB	NONE	NONE			AL0513	1						1	Erythema; Feeling hot; Oedema	FLU3~SANOFI PASTEUR~U1817AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MUR~MERCK & CO. INC.~0456P~UNK~IM~RA~MUMPS + RUBELLA (FOREIGN)~1	USA	Emergency room visit	Influenza
0247795	11/18/2005	AS	76.0	75		F	10/31/2005	Pt received flu and pneumonia on 10/26/05. Four hours later that night clients arm was very sore/painful- was pink and swollen 1/2 way down to elbow - difficult to left arm, chills next day symptoms slowly resolving - pain continued in arm especially with lifting arm.									Y	10/26/2005	10/26/2005	0		PUB	PUB	alka seltzer, aciphex 20mq day	cold with cough, runny nose and slight sore throat	allergies to mold pollen and grasses		AK200584	1						1	Chills; Injection site pain; Joint range of motion decreased; Swelling	FLU3~SANOFI PASTEUR~U1757AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247796	11/18/2005	AK	63.0	63		F	10/28/2005	Patient received Flu/Pneumo vaccines on 10/25/05. Patient complained of redness, swelling, pain all the way around arm. Patient in to see doctor at clinic. Patient reports feeling much better at time of phone call 13:20 10/28/05.									Y	10/25/2005				PUB	PUB	Synthroid				AK200585	1						1	Erythema; Pain; Swelling	FLU3~SANOFI PASTEUR~U1754AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0346R~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247797	11/18/2005	AK	67.0	66		F	11/01/2005	24 hours after vaccination, client experienced pain, redness, swelling from left deltoid down to elbow. No fever associated. The pain was excruciating that client ended up to ER. Client was put on Ciprofloxacin for 10 days.				Y					Y	10/20/2005	10/21/2005	1		PUB	UNK		NONE	NONE		AK200586	1						1	Erythema; Pain; Swelling	FLU3~SANOFI PASTEUR~U1754AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~3~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247798	11/18/2005	IA	70.0	70		M	11/15/2005	Left arm was sore and ached evening of 10/31/05. Morning of 11/01, left triceps red, sore for about 1 week.									Y	10/31/2005	10/31/2005	0	NONE	PUB	PVT	NONE	NONE	NONE			1						1	Erythema; Pain	FLU3~SANOFI PASTEUR~U1811AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0781P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247799	11/18/2005	PA	84.0	84		F	11/18/2005	5am on 11/17/05, awoke with severe dizziness, lightheadedness, nausea, sweaty/cold. She had difficulty walking, so she used a walker. Symptoms improved with time without treatment. 11/18/05 Still a little lightheaded in AM.									N	11/16/2005	11/17/2005	1	NONE	PVT	PVT	Chondrotin; Monopril; Iron; Coumadin; Vitamin; Glucosamine		Osteoporosis; GE Reflux; Hypertension; Anemia; Venous insufficiency (peripheral); Polymyalgia rheumatica; Defibrination syndrome; Edema; Osteoarthrosis; Esophagus disorder; Fibromyalgia and Myositis; Allergic reaction to some medications.			1						1	Difficulty in walking; Dizziness; Feeling cold; Hyperhidrosis; Nausea	FLU3~SANOFI PASTEUR~U1850AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247800	11/18/2005	TX	8.0	8		F	11/18/2005	Nausea, sneezing, fever 101, sore throat, headache. Head/forehead hurts to turn head. No muscle rigidity.									U	11/15/2005	11/17/2005	2		PVT	OTH	NONE	NONE				1						1	Headache; Nausea; Pharyngolaryngeal pain; Pyrexia; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~500426P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0247801	11/18/2005	CA	81.0	80		F	11/17/2005	Hives started on hands and spread to palm. by 9 pm started scratching legs and noticed big hives. Site of injection swollen, red, hoarse voice called nurse help line. Advised to go to ER arrived at ER at 10:45 pm given Benadryl which helped. Released by 1 am. On Monday some what better itching subsided. Today voice still hoarse, hives disappearing.				Y					U	11/12/2005	11/12/2005	0		PVT	MIL	Multivitamin;Calcium;Iron tablet	NONE	NONE			1						1	Dysphonia; Injection site erythema; Injection site oedema; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0247802	11/18/2005		4.0	4		F	11/18/2005	14 cm x 11 cm right thigh pink, blanchly, increase warmth area, tender.  7 cm x 6 cm left thigh pink, blanchly, increase warmth area ( but less pink than right and not warm). Same in clinic 2 days after vaccine administered than immunitization clinic. No fever, no limp									N	11/16/2005	11/16/2005	0	per immunization tech. rxn r thigh flu vaccine, rxn left thigh DTaP	MIL	MIL	albuterol MDI	cough	speech delay, s/p THA			1						1	Erythema; Feeling hot	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC148006AA~5~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1930AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0551P~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0247805	11/18/2005	NV	44.0	43		M	11/11/2005	Given vaccine on Wednesday 11/9/2005 and developed fever, chills, left arm ache on Thursday. Approx 3 circular area around injection site noted on Friday.									U	11/09/2005	11/09/2005	0	NONE	PVT	PVT		NONE	NONE			1						1	Chills; Injection site reaction; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U18658A~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0605R~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247806	11/18/2005	CA	5.0	4		M	11/14/2005	Lt arm swollen and warm, non tender 2 day after 1st 1 2 S. No Tx other than symptomatic.									U	11/11/2005	11/13/2005	2	NONE	PVT	PVT		NONE	NONE			1						1	Feeling hot; Oedema	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC14A006CA~5~IM~LA~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1816AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0705R~2~IM~RA~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~Y0235~4~SC~LA~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0234R~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0247829	11/18/2005	KY	64.0	64		F	10/31/2005	Patient received Pneumonia Vaccine in Rt Deltoid, and Influenza vaccine in Left Deltoid on 10/27/05.  By AM of 10/28/05 Rt. Arm had edema and redness below site to elbow.  Patients Privent MD instructed to talk Tylenol every 3 hours and apply ice for next 24-48 hours.       By 10/31/05 Redness relieved edema minimal.									Y	10/27/2005	10/28/2005	1		UNK	UNK					KY2005035	1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1761AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0287B~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247832	11/18/2005	NV	54.0	54		F	11/18/2005	Terrible fatigue, headache, low grade fever, nausea , excruciating joint and muscle pain. Missede day of work									Y	11/15/2005	11/16/2005	1		UNK	UNK	HCT Xanax	None	HPB, arthritis, multiple pharmaceuitical and environmental allergies, panic disorder			1						1	Arthralgia; Fatigue; Headache; Myalgia; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~u1869aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247833	11/18/2005	CO	40.0	40		F	11/18/2005	11/15 - Pt presented with red, itchy rash on face x 3 days; some small spots on arms.  Rash just erupted.  Pt took OTC claritin and topical hydrocortisone with little relief.  No new detergents, soaps, animals, pillow, bedding, towels or food.  Symptoms have never happened before.  Treated with methylprednisolone Dose-Pack.									Y	11/10/2005	11/12/2005	2	NONE	UNK	UNK	NONE	NONE - Healthy	NKDA, No latex or egg allergy. PMH - NONE			1						1	Rash; Rash pruritic	FLUN3~MEDIMMUNE VACCINES, INC.~500392P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0247834	11/18/2005	NC	33.0	33		F	11/18/2005	After receiving vaccination at 11:15am 11/14/05, patient developed sore throat 11/16/05 am.  Patient began OTC throat lozenges with menthol on her way to work.  During the day, headache and mild earache presented.  Patient took anacin (aspirin/caffeine).  In the evening, patient took Robotussin with expectorant and gargled with salt water.  Sleeping elevated was ok.  On 11/17 am, patient visualized yellow phlegm in back of throat and sore throat was worse.  Patient gargled with salt water.  Patient again had headache during the day.  Robotussin was continued throughout the day.  In the evening, voice was deminished.  At night, dissolving OTC product with decongestant and acetominophen was taken but sleep (elevated) was poorer and coughing began.  Today, third day of symptoms, patient has sore throat, mild upper back aches, fatigue and mild cough.  Overall, nasal symptoms have been insignificant.  Patient considers effects to throat and the level of fatigue significant and in the moderate range.  Patient is concerned that the reason to get a flu shot (two children at home under the age of three, one only 15month old) has now put her children at risk of acquiring the flu strain from her, as local supplies of thermosil free vaccine are limited and her children have not yet been vaccinated this year. This information is solely for the purpose of evaluating the safety of this lot of vaccine, not for the purpose of pursuing compensation or reimbursement for health care expenses.  Contrary to the rep, I believe that the purpose of this form is not to presume an association but to provide you with information you can combine with hundreds of other peoples' data to make that determination.  My assumption is that inactivated (killed) is not 100.00% effective.										11/14/2005	11/16/2005	2	Patient intends to recooperate over weekend at home.	UNK	UNK	11/14 was the last day of 10 days on 50mcg levothroxine for slightly low (but in normal range) hormone level diagnosed by blood test.	none	None significant.  Some IBS symptoms reported to Physician in 10/05.  Also tested low thyroid hormone in 10/05 - see box 17.			1						1	Back pain; Ear pain; Fatigue; Headache; Increased bronchial secretion; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U1764AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247835	11/18/2005	WA	47.0	46		F	11/18/2005	Within 24 - 48 hours developed overall body muscle pain, aches, stiff neck, tingling in arms to finger tips, upset stomach, head aches.  Lasting 1 week. Contacted Health District and was told to contact Dr. if symptoms worsen.									Y	10/20/2005	10/21/2005	1		UNK	UNK		none				1						1	Headache; Musculoskeletal stiffness; Myalgia; Pain; Paraesthesia; Stomach discomfort	FLUX~UNKNOWN MANUFACTURER~unknown~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247836	11/18/2005	WI	55.0	55		F	11/18/2005	At the site of injection, left Deltoid, patient has a red, raised, local reaction.  The affected area is oval in shape and about 3 inches by 2 inches.  Patient reports no other syptoms or problems.  Patient reported to the pharmacy 24 hours after receiving her vaccine.  Patient was instructed to contact her MD for treatment.									U	11/17/2005	11/17/2005	0		UNK	UNK	Unknown	None reported	No allergies reported			1						1	Injection site erythema; Injection site induration; Injection site reaction	FLU3~EVANS VACCINES~61503~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0247837	11/18/2005	FL	66.0	66		F	11/18/2005	Pt Reports Chills, Fever 101 F, headache, Nausea, Drowsiness by 9PM the day the vaccination was given. Redness and induration at injection site increased through day of report.  Took Alieve in the AM of !1/17. Seen in ER at 4:30 PM 11/17/05. ER physician perscribed tylenol and Benadryl every 4 hours and intermitent ice and heat to injection site.				Y					Y	11/16/2005	11/16/2005	0	None	UNK	UNK	Synthroid, Lipitor,Fosemex	None	Allergic to PCN, Hx Left Masectomy, Hypothyroid			1						1	Chills; Headache; Injection site erythema; Injection site induration; Nausea; Pyrexia; Somnolence	FLU3~SANOFI PASTEUR~U1872AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0748P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247839	11/18/2005	OH	45.0	45		F	11/18/2005	Chest pain approx. 20 minutes after recieving the flumist, ear lobes tingley and very jittery  I gave her benadryl, she called her doctor and went home to rest.  The synmptoms disapeared within 30 min of taking the benadryl.									Y	11/18/2005	11/18/2005	0		UNK	UNK	none	none	allergic to citrate			1						1	Feeling jittery; Paraesthesia	FLUN3~MEDIMMUNE VACCINES, INC.~500394P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0247841	11/18/2005	IA	31.0	31		F	11/18/2005	Patient developed hardness, swelling, redness at the deltoid injection site, and the redness traveled down to the armpit over then next several hours.									Y	11/15/2005	11/15/2005	0		UNK	UNK	Oxazepam 30mg at bedtime; Nicotine 21mg patch, Vitamin b complex with c;	none	Codeine allergy, sulfamethoxazole allergy			1						1	Erythema; Injection site erythema; Injection site induration; Injection site swelling	FLU3~SANOFI PASTEUR~U1802AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~9570903~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247842	11/18/2005	WI	32.0	32		F	11/18/2005	c/o dizziness, hives after 3 days of receiving influenza vaccine. The patient cont. to c/o of hives sporadically appearing/disappearing on arms, torso, neck and behind knees. c/o pruritis. The size of Hives range from size of a pencil eraser to golf ball size.									N	11/03/2005	11/06/2005	3		UNK	UNK	inhaler prn	Denies. Did state that on 11/10 c/o N/V.	Hx/o allergies (enviromental/seasonal)			1						1	Dizziness; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1839AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247843	11/18/2005	TN	61.0	61		F	11/18/2005	PATIENT EXPERIENCED RASH ON FACE AND HAS NOT BEEN TREATED. RASH IS STILL PRESENT, BUT IMPROVING (PER THE PATIENT) ON 11/18/05. ADVISED TO TREAT ALLERGY WITH BENDADRYL TABLETS ON 11/18/05.									N	11/09/2005	11/09/2005	0		UNK	UNK	UNKNOWN	NONE	NONE DOCUMENTED PER PATIENT			1						1	Rash	FLU3~SANOFI PASTEUR~U1866AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247844	11/18/2005	TX	21.0	21		F	11/18/2005	Altered mental status and generalized weakness. Discharge summary states encephalopathy. msv Medical records state abnormal vision, palpitations, anxiety, speech disorder. msv.					Y	2			Y	11/11/2005	11/11/2005	0	MRI of brain	UNK	UNK	none?	None known	1997 viral meningitis; 2002 umbilical hernia repair; 2004 stomach virus; 2005 back injury.			1						1	Anxiety; Asthenia; Encephalopathy; Palpitations; Speech disorder; Stupor; Visual disturbance	FLU3~SANOFI PASTEUR~u1744aa~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0247845	11/18/2005	OR	71.0	71		F	11/18/2005	I recieved the shot at 12 noon Monday and I woke up Tuesday with Hives and swollen eyes. This is Friday and I still have it.This was a flu shot										11/14/2005	11/15/2005	1		UNK	UNK						1						1	Face oedema; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247846	11/19/2005	MD	40.0	40		F	11/19/2005	Patient is my wife and a Russian immigrant (with fair English language skills). I am a PharmD (clinical pharmacist) and thus filing this report for my wife.  On the evening of Thurs, Nov 17 2005, at an employee & family flu vaccination clinic onsite my wife recived an IM flu shot, and approximately 2 hrs later, she experienced  laryngeal spasm and edema and difficulty breathing.  Throat felt swollen inside and out.  This persisted for about 3 hrs (from 10 pm to 1am, disrupting sleep) and gradually faded away by 3am. No treatment administered, but was seconds away from going to hospital.			Y						Y	11/17/2005	11/17/2005	0	none performed	UNK	UNK	none	none  (was treated with chemotherapy & radiation for Hodgkins Lymphoma 3 years ago, and now in complete remission)	allergic to sulfites in red wine (has experienced similiar reactions in past to certain red wines).  No known allergy to eggs or egg proteins (tolerate ingestion of egg food products OK).			1						1	Dyspnoea; Laryngeal oedema; Laryngospasm; Pharyngeal oedema	FLU3~SANOFI PASTEUR~U1850AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0247847	11/20/2005	CO	64.0	64		F	11/20/2005	Vaccine given at 9.30 am. Chills at 4.pm,weakness,headache,chough,sneezing and fever of 103.01 by 5pm.At 9pm,temp.102.02. Difficulty breathing,I have Asthma and COPD and use Oxygen.By morning felt much better.rough night of trying to sleep.Am doing OK now.									Y	11/18/2005	11/18/2005	0		UNK	UNK	Paxil,aciphex,combivent,serevent,pulmocort.	none	Asthma,COPD penacillan allergies			1						1	Asthenia; Cough; Dyspnoea; Headache; Pyrexia; Sneezing	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0247848	11/20/2005	WI	32.0	32		F	11/20/2005	Right after Flu shot, felt very fatigued which got worse throughout the day- developed fever and internal pain all over body- had difficulty breathing and experienced pain in lungs, very weak/no energy and fast heart rate. A few days later, broke out with rash all over arms and spreading to neck area.									N	11/12/2005	11/12/2005	0		UNK	UNK						1						1	Fatigue; Heart rate increased; Pain; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~?~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247849	11/20/2005	MI	58.0	58		M	11/20/2005	112 days after receiving vaccine developed left ear area pain and loss of sense of taste on left side of tongue. On day 6 after vaccine administration I expereinced the gradual onset of a loss of motor function on left side of face (peripheral VIIth nerve distribution, which was mild at first and progressed to a complete paralysis of motor function over the next 18 hours. The systems have persisted, now 9 days after receiving the vaccine. (Bell's Palsy)				Y					N	11/11/2005	11/13/2005	2	Diagnosis baserd on physical exam	UNK	UNK	Aspirin, Tetracycline	None	None Medical records state allergy. msv			1						1	Ageusia; Ear pain; Facial palsy	FLU3~SANOFI PASTEUR~U1912AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247850	11/20/2005	CA	80.0	80		M	11/20/2005	Patient broke out in a rash over most of his body. There was also swelling in the hands, feet and face.  This was treated in Urgent Care with an antihistimine shot followed by a course of Benadryl and the application of Triamcinolone Acetonide Ointment USP (0.1%).				Y					Y	11/08/2005	11/10/2005	2	none	UNK	UNK	Lovastatin, Verapamil, Hydrochlorothiazide, Ranitidine	none	none			1						1	Face oedema; Oedema peripheral; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0247166	11/21/2005	NE	84.0			F	11/11/2005	Information has been received from a pharmacist and daughter of the consumer concerning an 84 year old female who on Oct 23 2005 was vaccinated IM with a second 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 650453/0791P). The patients daughter called the pharmacist to report that on Oct 24 2005 her mother developed redness and swelling in the arm she received pneumococcal 23v polysaccharide vaccine. The patient was hospitalized on the evening of Nov 2 2005 with shortness of breath, rales, and pneumonia. The pharmacist reported that he pulled all of his pneumococcal 23v polysaccharide vaccine off his shelf and requested a lot check be done. At the time of the report the patient was reported as not recovered. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. 11/16/05 additonal terms -- chest pain, fever, chills, nausea/sr					Y				N	10/23/2005	10/24/2005	1	Unknown	OTH	OTH	UNK		Immunisation		WAES0511USA00613	1						2	Dyspnoea; Erythema; Pain; Rales; Chest pain; Chills; Drug ineffective; Dyspnoea; Erythema; Infection; Injection site hypersensitivity; Injection site oedema; Nausea; Oedema peripheral; Pneumonia; Pyrexia; Rales	FLU3~SANOFI PASTEUR~01806AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0791P~2~IM~LA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~0791P~2~IM~UN~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0247779	11/21/2005	WI	53.0	52		F	11/08/2005	1 hour after vaccination, developed hives around injection site with itching. Site red, hard, warm, swollen. Induration 2 in x 1 in 1/2 hour later developed generalized itching lasting 24 to 48 hours. Took Zyrtec for 4 days. 3 days less swelling. Still hard, slightly red, slightly itchy.									Y	10/07/2005	11/07/2005	31		PVT	OTH	Advair, Effexor, Singulair, Allegra, Cholestyramine,	NONE	Asthma, Seasonal allergies, sensitivity contact solution.			1						1	Feeling hot; Injection site hypersensitivity; Injection site induration; Injection site oedema; Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA131AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0247855	11/21/2005	FL	80.0			M	11/16/2005	Information has been received from a registered nurse concerning an 80 year old male patient, with an unknown medical history and unknown drug reaction/allergies, who on Oct 12 2005 was vaccinated (route unknown) in his right arm with a dose of pneumococcal 23v polysaccharide vaccine (650453/1791P). Concomitantly he was vaccinated in his left arm with a dose of influenza virus vaccine (unspecified). Subsequently, on an unspecified date, the patient developed chills, swelling of his arm, fever, and coughing. The patient was treated with gatifloxacin (Tequin), 400 mg, daily for 7 days. On an unknown date the patient recovered. The patients experiences were considered to be other medical events by the reporter (OMIC). Additional information has been requested.									Y	10/12/2005				OTH	OTH					WAES0511USA01538	1						1	Chills; Cough; Oedema; Pyrexia	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0791P~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247866	11/21/2005	OH	8.0			M	11/17/2005	Information has been received from a registered pharmacist concerning an 8 year old male with asthma who on Oct 18 2005 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 650454/0751P). Concomitant therapy that day included influenza virus vaccine (unspecified), in the other arm. Other therapy included montelukast sodium (Singulair) and budesonide (Pulmicort). On Oct 19 2005 the patient had redness and swelling of his left arm. He was seen by the physician on Oct 20 2005 and as a result of this visit he was directed to admit 23 hours short stay on Oct 21 2005. He experienced redness and swelling at the site and he would not could not move his arm. He also had nausea and vomiting. He received one dose of ceftriaxone sodium (Rocephin) (IM) dose unknown in physicians office. After his admission to the short stay unit he was placed on IV clindamycin. He was discharged home, readmitted to impatient unit on Oct 23 2005 because the localized reaction kept getting larger instead of smaller and it continued to progress. He was placed on IV vancomycin. He was discharged on Oct 25 2005. According to his mother he was still not back to normal. The patient was considered to be recovering. Additional information has been requested.				Y	Y				U	10/18/2005	10/19/2005	1		OTH	OTH	Pulmicort, Singulair		Asthma		WAES0511USA01518	1						1	Hypokinesia; Injection site hypersensitivity; Injection site oedema; Malaise; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0751P~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0247869	11/21/2005	CA	68.0	68		M	11/17/2005	Information has been received from a physician via a company representative concerning a male in his 60's who two weeks ago, on approximately Oct 28 2005 was vaccinated IM with 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. the patient was vaccinated with pneumococcal 23v polysaccharide vaccine and influenza virus vaccine ( unspecified lot # not provided) concurrently on separate sites. Two weeks ago, on approximately Oct 28 2005 the patient became hot, nauseated, had dry heaves and developed low blood pressure and bradycardia. An ambulance was called and the patient went to the hospital. The patient was treated with unspecified therapy. The patient was reported as recovered. There was no product quality complaint involved. Additional information has been requested.					Y				Y	10/28/2005	10/28/2005	0		UNK	UNK					WAES0511USA01992	1						1	Bradycardia; Hot flush; Hypotension; Nausea; Retching	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0247876	11/21/2005	MO	29.0	28		F	11/14/2005	Cellulitis at injection site 6 x 3 2 days after injection ER with IV fluid and antibiotic. Fever 102-103 2 days after inj. ER with 24 OBS for IV fluids. 1/24/06 Medical records reviewed stated patient experienced pain & redness at injection site, fever and was diagnosed with cellulitis.  Patient was pregnant.				Y	Y	2			Y	11/10/2005	11/12/2005	2	Blood culture + for staph epidermidis.	PUB	PUB	Prenatal Vitamins		Pregnant 20 weeks			1						1	Cellulitis; Injection site erythema; Injection site pain; Laboratory test abnormal; Pyrexia; Cellulitis; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~U1881AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577P~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~UNK~UNK~~RA~PNEUMO (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0247877	11/21/2005	IA	83.0	82		F	11/15/2005	Pt noticed redness and swelling in left deltoid where Pneumovax had been administered. On 11/13, erythema extended from the mid humerus down to the wrist and she was admitted to the hospital for observation. It was tender, warm to palpation, and there was moderate swelling. Treated with IV levo. 12-15/05  Review of 2-page medical records final dx cellulitis L arm (site of pneumonia vax).					Y	1			Y	11/10/2005	11/11/2005	1		PVT	UNK	Synthroid, Neurontin , Vitamin B1, B12		Codeine, some antibiotics			1						1	Cellulitis; Erythema; Feeling hot; Injection site hypersensitivity; Injection site oedema; Injection site pain; Injection site reaction	FLU3~SANOFI PASTEUR~U1819AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1007P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0247879	11/21/2005	ME	73.0	72		F	11/18/2005	Severe upper extremity pain at site of vaccine injection with generalization to extreme shoulder joint.				Y					Y	11/04/2005	11/04/2005	0		PVT	PUB						1						1	Arthralgia; Injection site pain	FLU3~SANOFI PASTEUR~U1846AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0605P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247880	11/21/2005	OH	3.0	2	1	M	11/21/2005	11/18 Quarter size knot with red circle. 11/19 golf ball size area of redness - entire thigh swollen. Advised Motrin every 6 hours and Benadryl 1 tsp every 6 (1 1/2 tsp)									Y	11/17/2005	11/18/2005	1		PVT	PUB	NONE		Asthma			1						1	Erythema; Oedema	DTAP~SANOFI PASTEUR~C2183AA~4~IM~~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1787DA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A98341H~4~IM~~PNEUMO (PREVNAR)~1	USA		Influenza
0247881	11/21/2005	MO				U		Metal taste in mouth 30-40 minutes after shot.									Y	11/17/2005	11/17/2005	0		PUB	UNK		NONE	Polymyositis			1						1	Dysgeusia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247882	11/21/2005	UT	8.0	8		M	11/21/2005	Local reaction - red, warm to touch. Treatment: Ice and heat, Benadryl				Y					Y	11/09/2005	11/11/2005	2		UNK	PUB	Singulair;Rhinocort;Pulmicort	NONE	NONE			1						1	Erythema; Feeling hot	FLU3~SANOFI PASTEUR~U1763AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0748P~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247883	11/21/2005	IL	1.27	1	.3	F	11/07/2005	Febrile Seizure occurred 1 day following vaccine administration.				Y					Y	10/25/2005	10/26/2005	1		PVT	OTH	Omnicef	resolved UM, NONE Medical records state otitis media. msv	One previous febrile seizure.			1						1	Febrile convulsion	FLU3~SANOFI PASTEUR~U1870AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~057R~3~~LL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~A98341A~4~~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0247884	11/21/2005	AZ	63.0	63		F	11/21/2005	Headache, sore throat, chills - 11/12/05 until 11/17 - then today 11/21/05 - felt ill again auto immune disorders same symptoms again no fever, body ache. Call MD - hasn't return call.									N	11/11/2005	11/12/2005	1		PVT	PUB	Klonopin (anti anxiety)	NONE	Auto immune disorders;Seasonal Allergies	flu like symptoms~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Chills; Headache; Immune system disorder; Pain; Pharyngolaryngeal pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247885	11/21/2005	IL	1.38	1	.4	M	11/17/2005	Diffuse hives, onset 3 days after injection treated with Orap  med and Benadryl				Y					Y	11/14/2005	11/17/2005	3	NONE	PVT	UNK		NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U17651A~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247886	11/21/2005	CA	65.0	64		M	10/28/2005	Pt received two vaccinations of flu. Pt did not display any untoward symptoms										10/28/2005				UNK	UNK						1						1	Unevaluable event	FLU3~SANOFI PASTEUR~1884AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247887	11/21/2005	FL	49.0	48		F	11/17/2005	Local reaction within 15 min of injection, redness, itching and hives lasting several hrs. (6 known reactions from 2 vials) total of 20 injections given									Y	11/06/2005	11/06/2005	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Erythema; Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61127~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0247888	11/21/2005	FL				F	11/17/2005	Localized reaction - hives - itching redness at injection site.									Y	11/08/2005	11/08/2005	0		PUB	PVT	NONE	NONE				1						1	Hypersensitivity; Injection site erythema; Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61127~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0247889	11/21/2005	FL				F	11/17/2005	Large area on deltoid with increase itching hives and redness lasting several hours at injection site									Y	11/08/2005	11/08/2005	0		PUB	PVT						1						1	Injection site erythema; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61127~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0247890	11/21/2005	FL				F	11/17/2005	Localized reaction - redness itching next day. Flu like symptoms									Y	11/08/2005	11/08/2005	0		PUB	PVT						1						1	Erythema; Influenza like illness; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61127~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0247891	11/21/2005	FL				F	11/17/2005	Severe flu like symptoms for two days									Y	11/08/2005	11/09/2005	1		PUB	UNK						1						1	Influenza like illness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61127~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0247892	11/21/2005	FL				M	11/17/2005	Localized reaction at injection site									Y	11/09/2005	11/09/2005	0		PUB	UNK						1						1	Injection site reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61127~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0247893	11/21/2005	AL	64.0	64		F	11/09/2005	Phone call 11/14/05 Pt had flu vaccine given 11/03/05 about 3 pm (had some flushing but di not tell anyone) 1 hr (4 pm) had flushed feeling head to toe. Almost fainted lasted approx 1 hr then had cold chills. Pt did not see MD. Just wanted to know about a flu shot next year. Referred pt to MD.									Y	11/03/2005	11/03/2005	0		PUB	PUB	gurmontil, protonic, atenolol, ativan, hormone patch		Hypertension, antideprssant		AL0516	1						1	Chills; Dizziness; Flushing	FLU3~SANOFI PASTEUR~U1817AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247894	11/21/2005	AL	50.0	49		F	11/09/2005	Pt states - temp 104 degrees at 10 pm 11/03/05 chills, headache, sob - did not go to ER or see MD. States she had fever and felt bad until 11/08/2005									Y	11/03/2005	11/03/2005	0		PUB	PUB	Tricor, Zetial, Cymbuta, Trazadone		Diabetes, depression	~Influenza (Seasonal) (no brand name)~~0.00~In Sibling	AL0514	1						1	Chills; Dyspnoea; Headache; Pyrexia	FLU3~SANOFI PASTEUR~U1817AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247895	11/21/2005	AL	34.0	34		M	11/09/2005	Information reported by patient's wife 11/09/2005. Pt developed shortness of breath, wheezing and throat feeling sore, about 7 - 7:30 pm 11/08/05. They consulted pt's sister who is a doctor. I was advised to use Albuterol inhaler (from their child's rx) and also to take Benadryl 50 mgm and prednisone 20 mgm (colick they had on hand) and additional dose of Benadryl taken at 12. Felt better by 6 am.									Y	11/08/2005	11/08/2005	0		UNK	UNK	Toprol		hypertension		AL0515	1						1	Dyspnoea; Pharyngolaryngeal pain; Wheezing	FLU3~SANOFI PASTEUR~U1881AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247897	11/21/2005	TN	42.0	42		F	11/08/2005	Received Fluzone .5cc IM at 12:30 on 11/05/2005. Ate lunch 4:30 no new food. Around 6 pm was fainting with a new type paint indoors and became short of breath, dizzy, and broke out in hives. Took Benadryl and has been symptom free since. Advised to notify PCP of incident.									Y	11/05/2005	11/05/2005	0		PUB	PUB			Asthma		TN05057	1						1	Dizziness; Dyspnoea; Urticaria	FLU3~SANOFI PASTEUR~U1838AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247898	11/21/2005	TN	59.0	59		F	11/07/2005	Husband reports patient became short of breath, wheezing, coughing about 3 hours post flu shot. Eyes red. Took her to ER where she was given O2 and a shot of benadryl and toBld to take an OTC Benadryl in the am.				Y					Y	11/04/2005	11/04/2005	0		PUB	UNK					TN05055	1						1	Cough; Dyspnoea; Ocular hyperaemia; Wheezing	FLU3~SANOFI PASTEUR~U1830AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247899	11/21/2005	NY	52.0	52		M	11/15/2005	Localized hive on forehead, underarms and wrists. Pt advised to self administer 50 mg Benadryl PO.									Y	11/15/2005	11/15/2005	0		PUB	PUB		NONE	Nuts;Pine;Environmental;PCN;Asthma;Eczema			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1836AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247900	11/21/2005	NY	25.0	24		M	11/15/2005	Near syncope,  hypotension, pale skin, tremors.				Y					Y	11/15/2005	11/15/2005	0		PUB	PUB		NONE	IDT			1						1	Hypotension; Pallor; Syncope; Tremor	FLU3~SANOFI PASTEUR~U1836AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247901	11/21/2005	PA	77.0	76		F		11-10-05 Patient presented to the State Health Center concerned about redness at the injection site of her vaccines she received at State Health Center on 11-08-05. On assessment by doctor CHN the upper left arm was notably red and warm to touch. The patient was referred to her primary care physician. 11-10-05 up on telephone follow up with her. she state that doctor did start her on an antibiotic, Cephalexin 500mg. QID X 10 days. 11-14-05 Follow up telephone call to patient: client states that the concerned redness on her left upper arm has resolved.				Y					Y	11/08/2005	11/09/2005	1		PUB	PUB	Lipitor;Diclofenac;Os-cal;Nexium	NONE	Arthritis;High Cholesterol;Allergies;Erythromycin;Amoxil			1						1	Feeling hot; Injection site erythema	FLU3~SANOFI PASTEUR~U1863AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247902	11/21/2005	NY	60.0	60		F	11/12/2005	Rash noted both arms and chest. No respiratory distress. Pt refused treatment									U	11/12/2005	11/12/2005	0		PUB	PVT		NONE				1						1	Rash	FLU3~SANOFI PASTEUR~U1911AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247903	11/21/2005	MS	8.0	8		M	11/09/2005	Approx 10 min after injection pt told mother I'm going blind and he passed out in seat of car and fell over. Went to ER and approx 1 hours later increased B/P and  is jerking  arms, legs and stomach ache. Stayed till 11:15 pm. doctor told me didn't know what cause  episode.				Y					Y	11/08/2005	11/08/2005	0		OTH	UNK	NONE	NONE	Heart Murmur;Zithromax Allergy;Anxiety Problems			1						1	Abdominal pain upper; Blindness transient; Blood pressure increased; Dyskinesia; Loss of consciousness	FLU3~SANOFI PASTEUR~U1838AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247904	11/21/2005	WY	68.0	68		F	11/18/2005	8 cm fairly well - demarcated erythematous, warm area and left shoulder - cellulitis				Y					Y	11/02/2005	11/03/2005	1		PVT	OTH	Nexium;Ambien;Toprol XL					1						1	Cellulitis; Erythema; Feeling hot	FLU3~SANOFI PASTEUR~U1773AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0706P~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0247905	11/21/2005	KS	4.0	4		M		48 hours after receiving flu vaccination seen in urgent care with bump swelling and redness.									Y	10/28/2005	10/29/2005	1	a	UNK	PUB	NONE	NONE	Asthma			1						1	Erythema; Swelling	FLU3~SANOFI PASTEUR~U1854AA~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247906	11/21/2005	KY	63.0	62		F	11/15/2005	Left arm swollen and red and itchy									Y	11/11/2005	11/13/2005	2	NONE	PUB	PUB	Premarin;Quinapril	NONE	NONE			1						1	Erythema; Oedema; Pruritus	FLU3~SANOFI PASTEUR~U1870Aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~AVENTIS PASTEUR~U15E6AA~UNK~IM~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0247907	11/21/2005	NH	7.0	7		M	11/16/2005	After receiving flu vaccine the next day area on arm a little smaller than the  bottom cm of a small coffee cup, was red and raised.  Patient was given Motrin every 6 hours. This lasted less than 32 hours.									Y	11/11/2005	11/12/2005	1		PUB	PUB	Zantac;Finase	NONE	NONE			1						1	Rash erythematous	FLU3~SANOFI PASTEUR~U1824AA~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247908	11/21/2005	MN	65.0	65		U		Severe body aches, in bed next day severe body aches, sick to stomach. Sunday felt a little better. Ok Monday about 10pm.										11/04/2005	11/04/2005	0		PUB	PUB	NONE					1						1	Nausea; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0247910	11/21/2005	OH	33.0	33		F	11/16/2005	Within 90 minutes of injection, was flushed, headache, body aches, nausea.									Y	11/11/2005	11/11/2005	0		UNK	UNK		NONE	NONE			1						1	Flushing; Headache; Nausea; Pain	FLU3~SANOFI PASTEUR~U1911AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247911	11/21/2005	OH	63.0	62		F	11/16/2005	Received vaccine before lunch and by 4:00 pm was having chills, low grade temp, coughing and became hoarse, headache, and sore throat. Took Tylenol, continued to have symptoms for 36 hours and then all symptoms subsided.									Y	11/11/2005	11/11/2005	0		PVT	UNK		NONE	Seasonal Allergies			1						1	Chills; Cough; Dysphonia; Headache; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U1911Aa~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247912	11/21/2005	MA	44.0	43		F	11/16/2005	Rash developed at vaccine site within 24 hrs spreading for 3 days. Area became red, hot, hard and very itchy. No treatment given. Pt con'ts with a slight rash, afebrile during reaction and has no tenderness.									Y	11/11/2005	11/12/2005	1	NONE	PVT	PUB	Cimetidine;Premarin;Haldol	NONE	NONE			1						1	Injection site erythema; Injection site pruritus; Injection site rash; Injection site warmth	FLU3~SANOFI PASTEUR~U1747AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247913	11/21/2005	NJ	35.0	34		F	11/14/2005	Ongoing hacking cough worsening since flu mist given									Y	11/04/2005	11/07/2005	3		PVT	UNK		NONE	NONE			1						1	Cough	FLUN3~MEDIMMUNE VACCINES, INC.~500389P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0247914	11/21/2005	NJ	12.0	11		F	11/14/2005	Patient had flu mist prior to symptoms of upper respiratory congestion.  Intermittent hacking cough . Symptoms worsening									Y	10/21/2005	11/14/2005	24	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Cough; Upper respiratory tract congestion	FLUN3~MEDIMMUNE VACCINES, INC.~50038AP~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0247915	11/21/2005	NJ	14.0	14		F	11/14/2005	Since flu mist given - upper airway congestion, cough- non production intermittent cough. Worsening.									Y	10/13/2005	11/14/2005	32	NONE	PVT	UNK	NONE	NONE				1						1	Cough; Lung disorder; Rhinitis	FLUN3~MEDIMMUNE VACCINES, INC.~500389P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0247916	11/21/2005	IL	69.0	69		F	11/14/2005	Three hrs after shot I experienced a weird feeling off and on. 2 hrs after that I was freezing to death couldn't stop shaking for 4 hrs-covered with 4 blankets. Warmed up to where I was burning up with 102.4 temp. Took 2 Tylenol and gradually subsided. Next day weak feeling and not so perky.									Y	11/01/2005	11/01/2005	0	NONE	UNK	OTH	Toprol XL;Aspirin 81mg	NONE	NONE			1						1	Asthenia; Ephelides; Feeling abnormal; Feeling cold; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U1849AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247917	11/21/2005	MS	35.0	35		F	11/06/2005	Burning reported immediately injection administration. 4 Nov 2005. Burning continued through day with warmth, reported at the site. Late that night itching/scaling  noted on today.									N	11/04/2005	11/04/2005	0	NONE	MIL	MIL	NONE		NONE			1						1	Injection site warmth; Pruritus; Skin burning sensation	FLU3~SANOFI PASTEUR~U1869AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247918	11/21/2005	TX	44.0	43		F	10/19/2005	4 hrs after vaccine severe coughing, wheezing, mucous in throat. Necessary to sleep in upright position to breath; used inhaler to relieve symptoms Duration 1 day at most sever; 2 more days less severe.										10/19/2005	10/19/2005	0		OTH	PVT		NONE	Environmental Allergies;Pollen, dust, mold, trees, grasses			1						1	Cough; Insomnia; Rhinitis; Wheezing	FLU3~SANOFI PASTEUR~U1806AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247919	11/21/2005	PA	60.0	59		F	11/14/2005	Every severe allergic reaction, with except for the hives. Breathing, heart rate, dizziness, fever, even  the left kidney - sever pain. No medical coverage for hospital visits.				Y					U	11/07/2005	11/08/2005	1		PUB	OTH	Tenormin;Aspirin;Nasonex;Zyrtec;Lorazepam	Ring ear left;Osteo;Arthritis;Hypertension;Elevated  Cholesterol;	Codeine;Anectine;Sulfa Amoxil			1						1	Dizziness; Dyspnoea; Heart rate increased; Pyrexia; Renal pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0247920	11/21/2005	NC	3.0	2	.7	F	11/15/2005	Pt received a flu vaccine and upon arrived at home pt with hive, no resp. distress, no cough , no wheeze. Mom gave her a dose of Benadryl with improvement.									Y	11/15/2005	11/15/2005	0		PVT	PUB		Had been seen in office on 11/7/05 diagnosed with Exanthem/Urticaria-mom state had gotten better	Cefzil - hives 1/05			1						1	Urticaria	FLU3~SANOFI PASTEUR~U788EA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247922	11/21/2005	NH	9.0	9		M	11/16/2005	After receiving flu vaccine the next day there was an area on the arm that was red and raised about the size of a small coffee cup. Patient was given Motrin every 6 hours. Area then had some bruising. Redness and swelling lasted with bruising for about 3 days.									Y	11/11/2005	11/12/2005	1		PUB	PUB	Advair 20 mg every am;Singular 0.3 every HR;Zoloft 75 mg every day	NONE	NONE			1						1	Contusion; Injection site hypersensitivity; Injection site oedema; Injection site swelling	FLU3~SANOFI PASTEUR~U1824AA~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247923	11/21/2005	NY	43.0	43		F	11/10/2005	States she felt ache and itchy all over felt sweaty, had buzzing in her ears, felt her mouth and throat were swelling. Stated this was her first influenza vaccine ever. State this reaction occurred at other times, but could not be specific about what may have caused it. Took Benadryl, self-prescribed, on her own with relief.									Y	11/01/2005	11/01/2005	0		UNK	UNK						1						1	Hyperhidrosis; Pain; Pharyngeal oedema; Pruritus; Swelling; Tinnitus	FLU3~SANOFI PASTEUR~U1762AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247924	11/21/2005	WI	0.68	0	.7	F	11/09/2005	Rash on leg and moved to back, stomach and arms. Pelvic area swollen, took Benadryl which made it better. MD recommends not giving second dose.				Y					Y	11/08/2005	11/09/2005	1		PUB	UNK		NONE	NONE			1						1	Rash; Swelling	FLU3~SANOFI PASTEUR~U1743NA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247925	11/21/2005	GA	0.51	0	.5	M		Redness to left arm, swollen and warm to touch. No fever but c/o pain when arm touched. Benadryl PO and cool compresses to arm as needed.				Y					U	11/14/2005	11/15/2005	1	NONE	PVT	PUB	NONE	NONE	Kawasaki Disease 2003			1						1	Erythema; Feeling hot; Oedema; Pain	FLU3~SANOFI PASTEUR~U1823AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247927	11/21/2005	OK	50.0	50		F	11/14/2005	Approx 1 hours and 20 min after receiving vaccine patient c/o nausea, dizziness and tingling to right side of her tongue.									Y	11/11/2005	11/11/2005	0		OTH	PVT		NONE	Sulfa;Keflex;Bactrim;PCN			1						1	Dizziness; Nausea; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61503~4~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0247928	11/21/2005	WA	40.0	39		F	11/14/2005	Decrease range of motion, pain and ache.									N	10/27/2005				PVT	OTH						1						1	Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~U1864AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247929	11/21/2005	PA	36.0			F	11/09/2005	Itching, hives- Got flu shot Thursday morning, Thursday afternoon, itching, Friday morning hives and itching, sneezing, Sunday mostly all gone.									Y				NONE	PUB	OTH	Synthroid	NONE	Allergies- Molds;Weeds;Dust Mites;Hypothyroid			1						1	Pruritus; Sneezing; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA13AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0247930	11/21/2005	WI	17.0	16		M	11/16/2005	Client received vaccine on 11-4-05 at 4:30 pm. On 11-9-05, he started to have itchiness, with no redness, that was unrelieved by Benadryl. It later developed that night into hives on his arm and both legs. He had welts on his legs and arms. He also complained of chest pain. On 11-9-05, he went to urgent care. On 11-15-05, he still had some itchiness and redness, that is helped by Zyrtec.				Y					Y	11/04/2005	11/08/2005	4	NONE	PUB	PUB	Minocycline started 10/8 missed a couple of doses	NONE	Sulfa			1						1	Chest pain; Erythema; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1904AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247931	11/21/2005	CT	6.0	6		F	10/27/2005	A pharmacist reported that a 6 year old female experienced swelling of nares, obstructed airflow, headache, nausea, vomiting and loss of appetite, 4-6 hours after receiving FluMist vaccine. The symptoms lasted for 48 hours. No other information was available at the time of report. The reporter causality is not provided. Additional information has been requested.									U	10/24/2005	10/24/2005	0		OTH	OTH					MEDI0003776	1						1	Anorexia; Dyspnoea; Headache; Nausea; Oedema; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~UNK~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0247932	11/21/2005	OH	62.0	62		M	11/25/2005	After flu shot within min had facial drooping and gotten a little worse. Occ. Thursday Nov 17, 2005.				Y					N	11/17/2005	11/17/2005	0	Labs CBC NL;Mono elevated	MIL	MIL		Bells Palsy				1						1	Facial palsy; Goitre	FLU3~SANOFI PASTEUR~U1900AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247934	11/21/2005	KY	30.0	30		F	10/26/2005	Reported 10/25/05 approx 1 1/2 - 2 hours after vacccine broke out in hives all over.  While driving home felt lik I was choking, took Benadryl 150mg 3times over 12-15 hours									Y	10/13/2005	10/13/2005	0	none	UNK	UNK		none	none		KY2005038	1						1	Choking; Urticaria	FLU3~SANOFI PASTEUR~U1794AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247935	11/21/2005	TX	40.0	40		F	11/21/2005	Entire right side of my body (arm and leg) hurt after the shot. Leg stopped hurting the next day.  My arm is still hurting a month later.  I can not lift anything heavy or raise my arm without feeling pain and it constantly tingles all the way down to my fingers.  I have been taking medications prescribed by my physician to help with the pain.  I took Mobic for 10 days and now I am taking Methylprednesolone.  The vaccine was administered at my worksite location and was paid by my company.  No one else has had a similar reaction.  The company is aware of the problem as well and has filed an internal report.				Y					U	10/27/2005	10/27/2005	0		UNK	UNK	none	none	none			1						1	Pain; Paraesthesia	FLU3~SANOFI PASTEUR~V1811AA~2~ID~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247936	11/21/2005	LA	30.0	30		F	11/21/2005	weasing, heart beat changes, aches, 101.8 fever, dizziness, nausia, back aches, cannot concentrate									N	11/17/2005	11/17/2005	0		UNK	UNK	currently also on trinessa birth control					1						1	Arrhythmia; Back pain; Disturbance in attention; Dizziness; Nausea; Pain; Pyrexia; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247937	11/21/2005	VA	55.0	62		F	11/21/2005	2x3 reddened rash to right Deltoid area; erythema and warmth present. Acetaminophen given for pain									Y	10/28/2005	10/30/2005	2	none	UNK	UNK	FUROSEMIDE, BISACODYL, ENALAPRIL, SYNTHROID,MOM, MVI, SENNOKOT,DILANTIN, DEPAKENE, MYLICON, LACTULOSE, CALCIUMW/D	NO ACUTE ILLNESS	MR-PREEXISTING.MEGACOLON; NKA			1						1	Injection site erythema; Injection site hypersensitivity; Injection site rash	FLU3~SANOFI PASTEUR~U1815AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247938	11/21/2005	MI	43.0	43		F	11/21/2005	6 hours after vaccine administration, onset of shortness of breath, wheezing.  Chills, low grade fever.  No treatment required.  Symptoms resolved in eight ours.									Y	11/15/2005	11/15/2005	0	none	UNK	UNK	Corgard Zantac	None	None	Chills, body aches~Influenza (Seasonal) (no brand name)~1~0.00~In Patient		1						1	Chills; Dyspnoea; Pyrexia; Wheezing	FLU3~SANOFI PASTEUR~U1903AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247939	11/21/2005	MD	46.0	45		M	11/21/2005	Received flu vaccine in the left deltoid on 11/04/05.  Started to have left arm pain on 11/06/05 which progressed to the right.  Reported to the ED on 11/07/05 with severe bilateral arm pain radiation from his neck requiring hospitilization.  He complained of  feverand pain from his waist up.  He denied lower expremity involvement. He had elevated LFT's and was diagnosed with viral syndrome.  Cardiac workup was negative and c-spine x-ray revealed DJD of the neck. He was discharged on 11/08/05 with dilaudid.  He followed up with his PCP and had a CT of the chest which revealed a small infiltrate in the LLL.  MRI of the neck revealed mild disc herniation at C-6.  He wqs treated with a Medrol Dose pack and Zithromax which initially relieved his pain.  He reported back to the ED on 11/16/05 and was admitted, again with severe bilateral arm pain.  Neuro consult determined symptoms were not caused by the C-spine and he was diagnosed with bilateral brachial plexitis.  The pain was relie ved by IV Medrol and he was discharged on 11/19/05. Medical record states dehydration. msv				Y	Y	6			U	11/04/2005	11/06/2005	2	Elevated ALT, AST on 11/07/05 CT of chest positive for LLL infiltrate MRI of C-spine positive for disc herniation C-6 Negative EBV, CMV, Lyme, HCVab Positive for HBVab Medical record states leukocytosis, hyperglycemia.	UNK	UNK	Multivitamin Supplement (brand unknown) Motrin	None reported	Arthritis, DJD C-spine Allergy: topical antifungals Medical record states spinal fracture, allergy. msv			1						1	Alanine aminotransferase increased; Aspartate aminotransferase increased; Dehydration; Hyperglycaemia; Laboratory test abnormal; Leukocytosis; Liver function test abnormal; Lung infiltration; Neck pain; Pain; Pyrexia; Radiculitis brachial; Viral infection	FLU3~SANOFI PASTEUR~U1825DA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0247941	11/21/2005	CO	47.0	47		F	11/21/2005	Swollen, itching eyes with discharge; swollen hands and feet; severe difficulty breathing; throat closing up; hives; stomach ache; headache; fever of 101; joint pain; severe congestion; ear ache.  Onset 3 hours after vaccine. Lasted 12 hours. Still have some congestion and itching eyes.									N	11/19/2005	11/19/2005	0		UNK	UNK	protonix 40mg per day	none	allergic to peniciilin; sulfa drugs. Acid reflux.			1						1	Abdominal pain upper; Arthralgia; Dyspnoea; Ear pain; Eye discharge; Eye irritation; Eye swelling; Headache; Nasal congestion; Oedema peripheral; Pyrexia; Throat tightness; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247942	11/21/2005	FL	72.0	0	.0	F	11/21/2005	Am having acute dizziness.										11/16/2005	11/17/2005	1		UNK	UNK		none	none			1						1	Dizziness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0247943	11/21/2005	MA	54.0	54		F	11/21/2005	I received flu shot at a clinic conducted by Board Of Health on Wednesday 11/17/05 around noon. I have received annual flu shots at this clinic for at least the last three years. I have been getting the flu shot for my predisposition to serious affect of flu with my life long asthma for over ten years. My asthma is in complete control. I have not had an attack in at least five years as of this year 2005. Adverse reaction to 11/17/05 Wednesday flu shot is as follows:  Starting with 7pm on the evening of the shot 11/17/05 I felt completely drained and weak and my hands were shaky; I could not stay up and went to bed. I was achy and generally unwell. I assume I was just tired. I awoke after a long sleep feeling generally rested at 5:30 a.m. the next day Thrusday 11/18, but I was still overcome with this achy and sore feeling like I had been beat up especially in my waist area and my muscles and bones just felt sore and achy. I figured I might be coming down with someting. As the day went on I began to think the unwell feeling which presisted and compounded throughout the day might be a non serious reaction to flu shot and it would pass since I did not get a live virus. I went to bed tired and early. I awoke on Friday 11/19/05 still feeling achy and beat up and sore all over; but this feeling started to diminish by late afternoon Friday and I was myself by that evening. I awoke on Saturday 11/20/05 feeling fine; but at around 1 p.m. I was completely overwhelmed with tortuous hives and itching full trunk and bright red skin neck to pelvis. I did not have any breakfast that morning, only half a cup of coffee, then went out for errands, I had eaten out at noon having a plain coffee, milk, sugar and chocolate chip cookie. I drove home all itchy, took Benadryl (two) and a shower; I called my doctor who said to come in. Arrived at his office at 2 pm with hives and redness all over my trunk but itching relieved by Benadryl. I was drowsy. My blood pressure was 110/60 which is my average range; my lungs were completely clear not even a wheeze; my lips and tongue and throat had no affect or itchy feeling. It was just the hives affecting me. I did not feel unwell, just drowsy from Benadryl. Doctor admin. epinepherine and observed me for about 2 1/2 hours. My husband had accompanied me and took me home with instruction to take anthistimine at bedtime and doctor's opinion the hives would not reappear. I arrived home at 5 p.m. At 6 p.m. the hives started to flare and red all over my trunk. I took an antihistimine; itching subsided; I went to bed at 8 p.m. very drowsy; I awoke at 3:30 a.m. Sunday 11/21 to a flare of hives and itching; just took another antihistimine without even getting out of bed to look in mirror; awoke at 8 a.m. and saw hives had overtaken my arms and legs. I called doctor who prescribed 60 mg. of prednisone once a day for next five days. I filled prescrip. took first dose of 60 mg. that Sunday 11/21 and another antihistimine around noon (about 24 hours after first hives showed). Fell asleep; woke by husband and had lunch in bed at around 3 p.m.; fell asleep and woke to full hives flaring now on my trunk and on my face; took antihistimine; ate dinner while hives spread now to my hands and feet (back and front) with slight discomfort on back of hands and feet from itching. At around 10 pm I felt normal; hives had subsided considerable and I assumed the prednisone was working; went to bed at 1 pm without antihistimine because I had a wake up call at 5:30 a.m. Monday 11/22. Woke at 3:30 a.m. 11/22 Monday with hives all over my trunk and legs, and pelvis itching; tried to sleep thru it because I had to wake at 5:30 and was so tired. Woke at 5:30 to see the hives everywhere and flared and terribly itchy; but not on my face. Took 60 mg. prednisone and anthistimine and shower. It is now 12:27 p.m. Monday 11/22/05. I have been ill in one way or the other reacting to something immediately after getting flu shot 11/17/05 with little let up. I went from general malaise the evening of shot into the entire next day and most of the next; felt better evening and morning before hives showed up at noon Saturday. These hives that are not going away but continue to flare despite epinepherine, prednisone two courses 60 mg each; and antihistimine every four to six hours. I feel itchy but can resist the urge as long as I have antihistimine working inside me. I have hives visible on body. They move from one area to another. Right now my chest is sort of itchy with hive markings. I am alarmed as this does not appear to be a food allergy....it has been over 72 hours sine I ate a chocolate chip cookie which I ingested a full thirty minutes before hives; but in any case was fully treated as if it were food allergy but with no relief in symptoms at all in 72 hours. It is looking less and less like a food allergy. I am on a course of prednisone 60 mg. a day which is making me very unsettled and jumpy. I feel itchy; and I am dependent upon antihistimine with their own side effects of dry mouth and tiredness as well as jittery nerves. I want to get off this merry go round. I want a diag. that makes sense. I think I reacted to the flu shot. I want to be taken seriously, as I am not one to complain, but to only speak up when I am alarmed. My husband, age 55 is in perfect health with no symptoms; my child age 17 is well with no symptoms. I hope this is not contagious. I don't think it was a food allergy reaction to a cookie I have eaten with no problems in the past. I don't have food allergies. The only thing that has happened to me or my family is I am reacting to the flu shot with initially malaise and achy bones and muscles; like I was beat up, sore; now unrelenting hives that are not responding to general allergy treatment. I  have not changed any cleaning products and we cook at home. I have not been out to eat since 2003; that is how infrequent our visits to a restaurant have been until I had coffee and cookie last Saturday. My diet has not changed. My vitamins (which I forget to take anyway) have not changed. I have no pets. I live in a house where we have lived for the past four years. THE BOARD OF HEALTH ASKED ME TO GO ONLINE AND FILL OUT THIS FORM AND THEN I FOUND YOU WANTED INFO LIKE MANUF. AND ROUT WHICH I DO NOT HAVE, BUT THE NURSE WHO HAS THIS INFO IS AWAY FOR THE DAY FROM OFFICE GIVING OUT FLU SHOTS; SO I WAS ASKED BY HER STAFF TO RELAY TO YOU TO CALL THEM FOR THAT DETAILED INFO WHEN YOU GET THIS REPORT. YOU CAN CALL THEM. THE NURSE IS USUALLY AVAILABLE AS WELL AS THE DIRECTOR AT THAT NUMBER. THANK YOU.				Y						11/16/2005	11/17/2005	1	Blood Pressure 110/60 when presented with hives to Dr.  No breathing problems No swelling of mouth or discomfort/itchy lips, etc. Administered epinepherine and observed 2 1/2 hours. Sent home with epi script, allergist referral and sample anthistimine to be taken once a day at bed time. Told patient hives should not be expected to flare again.	PUB	UNK	Advair 100/50 2x day Flonase nose spray 2x day	None. PLEASE CONTACT NURSE AT BOARD OF HEALTH FOR RECORDS ON WHAT FLU VACCINE WAS ADMINSTERED TO ME 11/17/05. SHE ASKED ME TO FILL OUT THIS FORM BUT DID NOT GIVE ME THE INFO REQUIRED BY YOU ON THE FORM SUCH AS MANUF. LOT NUMBER ROUTE. It was administered in my right arm and I had previous doses from local board of health (at least three) which they have records for in the nurse file under my name or from the records of previous clinics. CONTACT THE NURSE or speak to any one in the office; i.e., the director.	Asthma please call scituate town hall for their records on manufacturere and type of flu shot...office asked me to send form online, but nurse unavailable so staff asks you call directly			1						1	Asthenia; Erythema; Malaise; Myalgia; Pain; Pruritus; Tremor; Urticaria	FLU3~SANOFI PASTEUR~U1831AB~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247944	11/21/2005	WY	16.0	16		F	11/21/2005	Influenza vaccine administered 11/4/05. Recipient life flighted to pediatric intensive care 11/8/05 and placed on ventilator and dialysis. Dx with GoodPasture Syndrome and died 11/19/05. Terms added from Discharge summary rec'd 01/08/2006: shock, anemia, cardiac failure, menoptysis, fever, hypoxia, cough, lung infiltrate, tachypnea.  Terms added to pre-existing conditions: Obesity, asthma, depression, hypertension, amenorrhea./sr	Y	11/19/2005							N	11/04/2005	11/08/2005	4		UNK	UNK						1						1	Anaemia; Asthma; Cardiac failure; Cough; Glomerulonephritis; Haemoptysis; Hypoxia; Lung disorder; Obesity; Pyrexia; Renal failure; Respiratory arrest; Sepsis; Shock; Tachypnoea	FLU3~SANOFI PASTEUR~U1803AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0247945	11/21/2005	MD	48.0	48		M	11/21/2005	Hearing loss, severe tinnitus, pain, discomfort, fullness/pressure in both ears, fluid buildup(?). After additional time, contacted primary physician, assuming some type of ear infection, treated with Avelox antibiotic starting approx. 10/26/2005 for approx 7 days. Little relief. Then went to ear specialist, who put me on 9 day course of Prednisone started approx 11/11/2005. DID get some relief during treatment, but symptoms returned after finishing the Prednisone. Per follow up 2/28/2006: After approximately 9-10 weeks the seevere inflammation/congestion, especially in left ear DID subside somewhat. Maybe as a result of the 3 courses of rednisone and decongestions. Hearing test showe additional permanent hearing loss. Not sure what to do next. Also tinnitus is much worse 24x7. I saw in the news that Manufacturer was trying to get Flumist approved for children under 5 years old. I think this is a very bad idea. And flumist should not be administered to anyone with any history of ear problems, no matter how mild. Also don't forget that young children probably cannot describe post vaccine ear problems easily. You could only determine that from pre and post vaccine administration ear/hearing tests. That is not likely even to occur, except by chance. Don't approve for young children.				Y				Y	N	10/15/2005	10/17/2005	2	Pending...only hearing tests so far. Medical records state lab test abnormal. msv	UNK	UNK		None	Medical records state allergy. msv			1						1	Deafness; Ear discomfort; Ear pain; Hypoacusis; Inflammation; Laboratory test abnormal; Nasal congestion; Tinnitus; Ear discomfort; Hypoacusis; Tinnitus	FLUN3~MEDIMMUNE VACCINES, INC.~TBD~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500387P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Disabling	Influenza
0247946	11/21/2005	MI	70.0	70		F	11/21/2005	Pt and spouse state she had been recovering well after Cancer of lung and stomach and returned to work. 4-5 days after getting Flu shot 11/09/2004 she developed progressive weakness which was later DX as ALS. Death from ALS 11/05.  No additional terms added from Discharge Summary rec'd 11/28/2005/sr  Serum Sickness added from Med. Record rec'd 12/07/2005	Y	11/20/2005	Y		Y			Y	N	11/09/2004	11/14/2004	5		PVT	OTH	Synthroid, Lipitor, Iressa	Lung and stomach cancer	Allergic to PCN	N V D~Influenza (Seasonal) (no brand name)~~65.00~In Sibling|~Influenza (Seasonal) (no brand name)~~0.00~In Sibling		1						1	Asthenia; Demyelination; Neuropathy; Serum sickness	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0247957	11/21/2005	IA	59.0	58		F	11/21/2005	Flushing-redness on hands, legs, shoulder and buttocks comes and goes. Called her Dr. ; said to go on Claritin for  2 wks. I had suggested Benadryl, prior to talking to her Doctor.									N	11/11/2005			She's on Ultrasound therapy - uses lotion with therapy	OTH	OTH	Lipitor;Alprazolam;Norvasc;Levothyroxine;Toprol (XL) 25 mg	NONE	Allergy - PCN			1						1	Erythema; Flushing	FLU3~SANOFI PASTEUR~U1803AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247958	11/21/2005	WA	3.0	3		F	11/17/2005	Head down clenched up, stiff, eyes rolling back in head, wet her pants, 5 minutes after event fell asleep.				Y					Y	11/10/2005	11/10/2005	0	Blood work done 11-10-05;EEG done 11-21-05	PVT	PUB	Multi Vitamin	Seborrhea;Torticollis				1						1	Eye movement disorder; Insomnia; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U1816AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247959	11/21/2005	VA	33.0	33		F	11/01/2005	Fever 102.2 oral for 24 hours, malaise, muscle aches, congestion, sneezing, headache - symptoms lasted for 5 days. Treated with Tylenol and decongestant.									Y	10/25/2005	10/26/2005	1		PUB	PUB	Oral Contraceptive Pills	NONE	NONE	Flu like symptoms and pain~Td Adsorbed (no brand name)~2~20.00~In Patient		1						1	Headache; Malaise; Myalgia; Nasal congestion; Pyrexia; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~500388P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0247962	11/21/2005	CA	35.0	35		F	11/21/2005	Stated that shortly after receiving immununization she had shakiness, lightheadedness and itching on both arms but no shortness of breath.  Took Benadryl 25 mg about one and half hours after immununization.  When evaluated at 3pm her BP was 142/100 and pulse 80.  After she left she was seen in UC where she fainted and was taken to ER where she had a chest x-ray, EKG and head CT.  Was discharged to home 3AM 10/21/05 from ER.				Y					Y	10/20/2005	10/20/2005	0		UNK	UNK	None	None	No known medical allergies			1						1	Dizziness; Pruritus; Syncope; Tremor	FLU3~SANOFI PASTEUR~U1754AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247963	11/21/2005	ME	33.0	33		F	11/21/2005	On 11-16-05 approx. 2 hours after LAIV, developed dizziness, chills, exhaustion. 11-17-05, aching, prostration, vomiting, headache, fever. 11-18-05 cough, runny nose.									Y	11/16/2005	11/16/2005	0	none	UNK	UNK		none	none			1						1	Chills; Cough; Dizziness; Fatigue; Headache; Pain; Prostration; Pyrexia; Rhinorrhoea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500389P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0247964	11/21/2005	FL	70.0	70		F	11/21/2005	Soreness and reduced ROM of left arm around 8 PM on day of injection. Swelling and erythema of left arm from injection site to antecubital area on inner aspect of arm next morning.									U	11/17/2005	11/17/2005	0	None	UNK	UNK	None	none	None			1						1	Injection site erythema; Injection site swelling; Joint range of motion decreased; Myalgia	FLU3~SANOFI PASTEUR~U1826AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0771P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247965	11/21/2005	WI	1.7	1	.7	F	11/21/2005	severe hives, resolved with Benadryl				Y					Y	11/15/2005	11/16/2005	1		UNK	UNK	vitamins	none	none			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1817AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0247876	11/22/2005	MO	29.0	28		F	11/16/2005	Temperature evening of injection. Next day reddened and painful site. 11/12/05 swollen, red, painful site in ER. Ancef IV then Keflex PO QID. Follow up Monday 11/14/2005 with Dr. 11/14/2005 Admitted to hospital with Cellulitis. Mefoxin one gm IV Q6. Dismissed 11/15/2005 on Keflex.				Y					U	11/10/2005	11/10/2005	0	WBC 21-0, blood culture, latex negative staphylococcus.	UNK	UNK	Prenatal Vitamin	UNK	6 months pregnant			1						2	Cellulitis; Injection site erythema; Injection site pain; Laboratory test abnormal; Pyrexia; Cellulitis; Injection site hypersensitivity; Injection site oedema; Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~U1881AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577P~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~UNK~UNK~~RA~PNEUMO (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0248018	11/22/2005	NC	5.0	5		M	11/07/2005	Severe swelling of left leg, where immunization was given. Painful, warm to the touch. Pt was hospitalized. Vaccine given 11/02, hospitalized 11/03.					Y	1			Y	11/01/2005	11/02/2005	1		PVT	PVT	Singular, Flovent	Bilateral serous otitis media, Sinusitis	Asthma, Allergies	arm swelling~Influenza (Seasonal) (no brand name)~~0.00~In Patient	NC05102	1						1	Feeling hot; Injection site oedema; Injection site pain; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U1747AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0248019	11/22/2005	WA	80.0	80		F	10/07/2005	Approx 10 minutes after vaccine had nausea, dizziness, extremities were cold, facial sweating, throat tightening. 12/2/05- Per review of medical records chief complaint in ER was SOB & dyspnea. Received epinephrine in pharmacy prior to arrival at ER. Recovered. Rx in ER with Phenergan and given Rx for Benadryl to take home for PRN use. Final diagnosis was allergic reaction to flu shot'. Anaphylaxis was NOT circled on ER sheet.  Sent home in an hour.			Y	Y					Y	10/07/2005	10/07/2005	0		OTH	OTH	Nexium, Ditropan XL					1						1	Dizziness; Hyperhidrosis; Hypersensitivity; Nausea; Peripheral coldness; Throat tightness	FLU3~SANOFI PASTEUR~LU1805AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0248020	11/22/2005	FL	72.0	72		M	11/14/2005	Given vaccine on 11/07/2005 at 2:00pm, into left shoulder area by nurse, pain in arm started a about 4:30 - 5:00pm, same day with fatigue. By 10 pm same day I could not use my left arm, could not lift, push, pull with it, as if paralyzed. Hand left could not grip or hold. Pain severe 10 on scale of 0 to 10. Had to have assistance to get up out of Bed, Chairs. Could not stand and use a walker, venor propel wheelchair. I am still unable to use my left arm, though pain is now 5, swelling still to some degree. - 12/15/05 Review of medical record reveals no definitive diagnosis, no mention of paralysis, and no additional symptoms. 1/1/10 - follow up-  still have limited use of left arm; still limited strength in grip of left hand;still lingering pain in left shoulder and were flu injection was given;still  can feel a ball in left arm where injected as if it formed a lump of fluid. ive heard people, many of them, have died from that shot. you ought to be more vigilant before administering that poison ! Cannot use vaccinated arm much as it is  in constant pain (5 on a scale of 0-10) with pain up to 10 when I do certain things - which I most put up with to get up from chair, bed, couch, wheelchair (cannot use to move forward, but pain is less backing it up pushing on wheels in reverse. My doctor of health care plan says the injection may have gone into a nerve, of which he says nothing can be done. I'm not getting any better, but getting worse. I have been advised to contact a lawyer, which I am tempted to do -as this is ruining my life by taking away one  of my arms!				Y				Y	N	11/07/2005	11/07/2005	0	12/15/05 Per review of medical records an x-ray of the shoulder was normal.	UNK	UNK	Glyburide, Fosinopril, Aspirin, Vitamins, Protonix, Metformin	Have 3 spinal injuries for several years, Diabetes type 2 for 4 years.	Have 3 spinal injuries for several years, Diabetes type 2 for 4 years.			1						1	Fatigue; Grip strength decreased; Hypokinesia; Injected limb mobility decreased; Injection site mass; Injection site pain; Monoplegia; Oedema; Pain in extremity; Paralysis; X-ray normal	FLU3~SANOFI PASTEUR~U1912AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0248021	11/22/2005	NY	1.47	1	.5	F	11/17/2005	Generalized Seizure with fever. No additioanl terms added form Discharge summary rec'd 01/04/2006. Per annual report-Projectile vomiting and fever on 11/10/05. 01/04/2005 Records rec'd from Sinaia Hospital.  Diagnosis was benign febrile seizure as originally stated on VAERS form/. 1/19/06Received letter from PCP and medical records which were copies of ER records.  Additional terms found were cyanosis, emesis and loss of appetite. 1/30/06 Parent called to report that she had forgotten to report that patient had received flu shot simultaneously with MMR on 11/2/05.  Child had severe vomiting and fever on 11/10/05 & was taken to ER on 11/11/05.  Patient developed a mild rash several days after d/c from hospital which has now resolved.  Mother also reported that child had episode of flu symptoms on 1/26/06.  Child is scheduled for varicella vaccine & Mother requested information sheet which was mailed to her. 7/27/06 Received T/C from parent who reported that patient received chickenpox vax today.  Instructed that if she has an AE to file another VAERS report.  Stated understanding of same.  Also wanted noted in patients file that she has had several high fevers of 104 not associaed w/any vax but no further febrile seizure activity.  Mother plans to t/c when child received school vax w/further update.				Y	Y				Y	11/02/2005	11/12/2005	10		PVT	PVT						1						1	Convulsion; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1743AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0601R~1~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Hospitalisation	Influenza
0248022	11/22/2005	IN	0.51	0	.5	M	11/10/2005	Parent reports pt developed paleness, lethargy. Parent became very concerned and called ambulance. Discharge summary states vomiting. msv				Y	Y				Y	11/07/2005	11/07/2005	0		PVT	PUB	Tylenol					1						1	Lethargy; Pallor; Vomiting	DTAP~SANOFI PASTEUR~C2222AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1765GA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE766AA~4~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A56677C~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0248025	11/22/2005	TX	7.0	6		F	11/22/2005	Pt broke out with hives on lower abdomen, lower back, and inner thighs. Given IM Benadryl and Epi at ER. PO Benadryl steroid Tx x 7 days				Y					Y	11/18/2005	11/18/2005	0		PVT	UNK		NONE		rheumatoid arthritis~Hep B (no brand name)~1~13.00~In Sibling		1						1	Urticaria	FLU3~SANOFI PASTEUR~U1811AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248026	11/22/2005	CO	49.0	49		F	11/10/2005	Discharge from eyes, sensation of tightness and congestion in lungs, soreness and aching in arm, shoulder and neck of injection site.									Y	11/09/2005	11/09/2005	0		PUB	PUB	Prozac x 1 week prior to vaccination	NONE	NONE			1						1	Eye discharge; Injection site pain; Lung disorder; Nasal congestion; Pain	FLU3~SANOFI PASTEUR~U1863AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248027	11/22/2005	KY	34.0	34		M	11/17/2005	Phone call received at 9:30am 11/16/05 from worksite that pt c/o sore throat, swelling and was not ill. Advised office person to have pt seen by physician ASAP. Work to await next call as pt did not have a cell phone. Called at 9:50am from work site as a 3 way with pt now in out of town. Pt stated that around 11:30am on 11/13 he felt like his throat was swelling, sore and had chills. Denies any other symptoms. Advised to seek medical help ASAP. Call placed to work site 11/17, unknown if pt went to doctor but is working.									U	11/15/2005	11/15/2005	0		OTH	PUB		NONE	NONE			1						1	Chills; Oedema; Pharyngolaryngeal pain; Throat tightness	FLU3~SANOFI PASTEUR~U1905AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248028	11/22/2005	MA	46.0	46		F	11/17/2005	6 x 8 cm indurated, warm, erythematous, itchy, non tender, no fever.				Y					Y	11/04/2005	11/04/2005	0		PVT	PVT						1						1	Erythema; Feeling hot; Injection site induration; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61321~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0248029	11/22/2005	MA	8.0	8		M	11/17/2005	Shot given, and upon return home dizzy, vomited and rashy. Did resolve over several minutes. Then local reaction x 2-3 days.									Y	10/12/2005	10/12/2005	0		UNK	UNK		NONE	Asthma			1						1	Dizziness; Injection site reaction; Rash; Vomiting	FLU3~SANOFI PASTEUR~U1792AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248030	11/22/2005	CA	4.0	4		F	11/16/2005	Right deltoid 75mm x 86mm red, swollen, hot to touch, Benadryl and Tylenol.									U	11/14/2005	11/16/2005	2	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Erythema; Feeling hot; Oedema	DTAP~SANOFI PASTEUR~C2254AA~5~~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1865AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0424~4~~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0291R~2~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0248031	11/22/2005	NV	69.0	68		F	11/16/2005	Hives over body. Controlled with Benadryl 50 mg one time.  Then 2 times Benadryl 50 mg no help. Big welts, itching. Breathing problems and choking on 10/23/2005. To Emergency hospital for injections and RX of antihistamine and prednisone 5 days. Symptoms lasted 8 days. Doctor advised no more flu shots very dangerous.				Y					Y	10/21/2005	10/23/2005	2		OTH	OTH	Femhrt 1/5 daily	NONE	Allergy to penicillin family, bee stings.			1						1	Choking; Dyspnoea; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~UNK~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248032	11/22/2005	OH	37.0	37		F	11/17/2005	Tachycardia, sore throat x 24 hours.									Y	11/15/2005	11/15/2005	0		PUB	OTH						1						1	Pharyngolaryngeal pain; Tachycardia	FLU3~SANOFI PASTEUR~HU1872AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248033	11/22/2005	MA	1.06	1	.1	M	11/18/2005	Pt with rash looks like several varicella lesions on back and arm no systemic symptoms. Don't appear to bother patient, very minor problem.									Y	11/01/2005	11/16/2005	15		PVT	PUB		URI SX no fever				1						1	Dermatitis bullous; Skin ulcer	FLU3~SANOFI PASTEUR~U1788HA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0610P~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A94456B~4~IM~LA~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0893P~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0248034	11/22/2005	RI	8.0	7		M	11/16/2005	Swelling of left arm, rash at injection site, mild erythema, no tenderness.									Y	11/14/2005	11/16/2005	2		MIL	MIL						1						1	Erythema; Injection site rash; Oedema	FLU3~SANOFI PASTEUR~U1872AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248035	11/22/2005	MA	30.0	30		F	11/17/2005	Received vaccination at 4 pm 11/15/05, at 10am 11/16/2005 developed chills and left arm began to be sore, swollen and red at site of injection. As day progressed began headache, fatigue, dizziness and shortness of breath,muscle pains, back ache. Went to ER at 3:30pm, received 80 mg Advil, Temp at that time 103 and Toradol.				Y					Y	11/15/2005	11/16/2005	1	Blood work obtained, blood cultures.	PUB	PUB	Keflex PO		Car accident 1980 Splenectomy			1						1	Back pain; Chills; Dizziness; Dyspnoea; Fatigue; Headache; Injection site hypersensitivity; Injection site oedema; Myalgia; Pain	FLU3~SANOFI PASTEUR~U1854AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577R~2~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~MASS. PUB HLTH BIOL LAB~TD137~3~IM~LA~TD ADSORBED (TDVAX)~1	USA	Emergency room visit	Influenza
0248036	11/22/2005	KS	5.0	4		M	11/11/2005	Seen in ER Hives (influenza Vaccine) last 24 hours. Urticaria on legs,feet, and buttock. TX Orapred.				Y					Y	10/24/2005	10/25/2005	1	NONE	PVT	UNK	Miralax	Rash	History cleft lip and palate with repairs, skin reaction to tape.			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1805AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248037	11/22/2005	MA	73.0	73		M	11/17/2005	Left upper arm redness, slight swelling, painful to touch, afebrile, seen in ER, no RX. 11/17/2005 client able to golf 2 days after shots.				Y					Y	11/15/2005	11/15/2005	0	NONE	PUB	PUB	Vasotec 5mg OQ		Hypertension			1						1	Erythema; Oedema; Pain	FLU3~SANOFI PASTEUR~U1854AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577R~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0248038	11/22/2005	VA	70.0	69		F		chills, severe headaches, sore muscles, sick at stomach, lifeless, eye balls hurt, just like flu symptoms. Took 4 days to recuperate.				Y					Y	11/10/2005	11/10/2005	0	NONE	PUB	UNK		NONE	NONE			1						1	Chills; Eye pain; Feeling abnormal; Headache; Influenza like illness; Myalgia; Stomach discomfort	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0248039	11/22/2005	MI	70.0	69		F	11/14/2005	Has raised rash on chest and arms that causes intense itching off and on. This also occurred last year after flu shot. Seen doctor on  11/16/2005 started on Zyrtec and will stop levothy roxine 50 mcgs x 7 days and will try different generic thyroid. Prior to next years flu shot to start Zyrtec x7 days.				Y					N	11/10/2005	11/12/2005	2		MIL	PVT	Crestor, Cardizem, Thyroid levothyroxine	NONE	Increased B/P, cholesterol.	rash, itching~Influenza (Seasonal) (no brand name)~4~68.00~In Patient		1						1	Pruritus; Rash; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U1936AA~5~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248040	11/22/2005	CA	3.0	3		F	11/17/2005	6 1/2 cm local reaction on left arm.									U	11/15/2005	11/15/2005	0		PVT	PVT						1						1	Injection site reaction	FLU3~SANOFI PASTEUR~U1807AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248041	11/22/2005	NY	26.0	25		F	11/18/2005	Arm swelling right after injection,  had reaction before to tetanus injection.									Y	10/17/2005	10/17/2005	0	NONE	PVT	PVT	PPD, Atenolol		Mean venous pressure			1						1	Injection site oedema	FLU3~SANOFI PASTEUR~U1804AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248043	11/22/2005	MN	5.0	5		M	11/17/2005	5 days after Flu vaccine macular pink rash around the immunization site occurred. Rash was itchy but not painful. No induration. No respiratory SXS.									U	11/08/2005	11/13/2005	5		PVT	UNK						1						1	Injection site hypersensitivity; Injection site rash; Pruritus; Rash macular	FLU3~SANOFI PASTEUR~U1802BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248044	11/22/2005	GA		1	.0	M	11/17/2005	Began with lesion at the vaccination site. 1 cm crusted area. Centany cream TID x 7/10 days to lesion.				Y					U	10/21/2005	11/05/2005	15		PVT	PVT						1						1	Injection site reaction; Skin ulcer	FLU3~SANOFI PASTEUR~U1850AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0028R~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0550R~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0248045	11/22/2005	IA	63.0	62		F	11/17/2005	5:00 pm - Unsteady on legs. 8:00 pm- Fever-Chills-Headache.									Y	11/07/2005	11/07/2005	0		OTH	OTH	NONE	NONE	Chronic Hepatitis C			1						1	Balance disorder; Chills; Headache; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0248046	11/22/2005	WI	31.0	30		F	11/10/2005	Pt received flu vaccine at Elementary School 11-2-05. 11-5-05 Developed arthralgia, fatigue, temp. 11-8-05 Generalized rash.				Y					Y	11/02/2005	11/05/2005	3	BC;Chem 8- WNL	OTH	OTH	Ortho Evia Patch	NONE	NONE	Rash~Influenza (Seasonal) (Fluzone)~~28.00~In Patient		1						1	Arthralgia; Fatigue; Rash	FLU3~SANOFI PASTEUR~U1854AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248047	11/22/2005	MO	56.0	56		F	11/11/2005	Pt c/o tongue swelling on 11/10/05 with food tasting funny on 11/10/05. Today 11/11/05 right eye won't close and right side of mouth dribbles and droops.										11/09/2005	11/10/2005	1		PUB	OTH	NONE	NONE	Ceclor;Penicillin			1						1	Drooling; Dysgeusia; Eye disorder; Tongue oedema	FLU3~SANOFI PASTEUR~U1881AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248048	11/22/2005	KY	83.0	83		F	11/17/2005	About one hour after getting the shot, I became very dizzy, it lasted about one hour then slowly went away. No treatment.									Y	10/26/2005				PUB	UNK	Mestinon;Metoprolol;Levothyroxine	Myasthenia Gravis	Mitral Valve Prolapse			1						1	Dizziness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0248049	11/22/2005	IL	5.0	4		M	11/16/2005	Inflammation erythema at injection site. 4 1/2 x 2 cm after injection. Noted red welts next day. Seen 11/14/05 diagnose with erythema				Y					Y	11/07/2005	11/08/2005	1	Clinical observation	PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site inflammation; Urticaria	FLU3~SANOFI PASTEUR~APU1814AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248050	11/22/2005	IN	1.12	1	.1	F	11/11/2005	NONE										10/21/2005				PVT	MIL	NONE	NONE	NONE			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U1765EA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~1169M~UNK~IM~LL~HIB + HEP B (COMVAX)~1	USA		Influenza
0248051	11/22/2005	CA	49.0	49		M	11/11/2005	Hives appeared on right forearm first, then left forearm. Lasted approx. 15 min.									Y	11/21/2005			NONE	PVT	PVT	NONE	NONE	Allergy Dust mites			1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61501~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0248052	11/22/2005	CA	3.0	2	.7	M	11/16/2005	Wheezing, nasal congestion for 3 weeks. No prior history. Treated with Flovent and Albuterol.				Y					U	10/18/2005	10/18/2005	0	NONE	PVT	PVT	NONE	Conjunctivitis	NONE			1						1	Nasal congestion; Wheezing	FLU3~SANOFI PASTEUR~U1848AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248053	11/22/2005	MD	62.0	62		M	11/17/2005	4 hours after injection, client developed severe shortness of breath, with wheezing and tightness in chest. Took 3 (Benadryl PO) 2 hrs after symptoms developed and used Albuterol inhaler and symptoms were resolved in 24 hours.									Y	11/04/2005	11/04/2005	0		OTH	OTH	NONE	NONE	Seasonal Allergies			1						1	Chest discomfort; Dyspnoea; Wheezing	FLU3~SANOFI PASTEUR~U1826AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248054	11/22/2005	GA	28.0	28		F	11/22/2005	Pt has welps on neck and left arm, stated started about 10 am (11-22-05), received flu vaccine on 11-21-05. Took Bactrim DS on 11/21/05 as well. Advised stop Bactrim see physician who ordered. Follow-up Information 14-APR-2006: Prob reaction to Bactrim									Y	11/21/2005	11/22/2005	1	Follow-up Information 14-APR-2006: Note * Pt tested later - must have been Bactrim.	PUB	PUB	Bactrim DS	NONE	NONE			1						1	Laboratory test; Urticaria	FLU3~SANOFI PASTEUR~U1930AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248055	11/22/2005	VA	39.0	39		F	11/22/2005	There is a small spot approx 3 mm circle on arm where she states flu vaccine was given on 11-16-05, that is flesh colored or lack of pigmentation. She states it was not there prior to the flu shot. It is flat and doesn't itch or hurts. No treatment received.									U	11/16/2005				PUB	UNK		NONE	Allergic: PCN;Tylenol;Vicodin;Benadryl			1						1	Pigmentation disorder	FLU3~SANOFI PASTEUR~U1910AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248057	11/22/2005	PA	48.0	48		M		Pneumovax given 11/14/05 right arm. Seen 11/16/05 C/O low grade temp 99.5, bright erythema; splotchy warm around right upper arm. 2% Cellulitis. Keflex 500mg  t t.i.b. every  5 days. Benadryl 25mg t every 6 hrs prn.									Y	11/04/2005	11/16/2005	12		PVT	PVT		Dizziness;Depression	Stroke;HTN;Neuropathy			1						1	Cellulitis; Erythema; Feeling hot; Pyrexia; Rash maculo-papular	FLU3~SANOFI PASTEUR~U191LA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0750P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248058	11/22/2005	PA	67.0	66		M	11/22/2005	11-18-05 t 97.7- right arm tenderness, redness, swelling, cellulitis. Right arm 22 cm x 36 cm erythema. Right arm 2.54 cm > than left arm. Keflex 500 mg t T.I.D. times 7 days									Y	11/16/2005	11/17/2005	1		PVT	PVT		CAD;Neck pain				1						1	Cellulitis; Erythema; Swelling; Tenderness	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0750P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248059	11/22/2005	IL	53.0			F	11/22/2005	In am 11/18/05 by 11 pm localized injection reaction possible allergic response to Fluzone 2 x 3 x 1 1/2 elevation, hard, red, swollen. Intensely itchy hot area around IM injection site. Resolving ecchymosis mild swelling persist.									Y				NONE	PUB	MIL	Allegra;Flonase;Diuretic	NONE	HTN;Environmental and Rx Allergy PCN;EES			1						1	Erythema; Hypersensitivity; Injection site induration; Injection site reaction; Oedema; Pruritus	FLU3~SANOFI PASTEUR~U1870AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248060	11/22/2005	KS	48.0	47		M	11/22/2005	Within 1 hr of shot developed severe headache (still has) sore muscle (soreness & stiffness) at arm and shoulder that has gone down between his shoulder blades. He went to doctor and they did blood tests, chest x-ray and heart monitor. These test seem OK. Wife states that evening after shot he could hardly get upstairs was weak and short of breath. He has taken 3 days of after prednisolone  now on a muscle relaxant for one week.				Y					N	11/04/2005	11/04/2005	0		PUB	UNK		NONE	Allergies to cotton;rag weed;sea weed			1						1	Asthenia; Dyspnoea; Headache; Musculoskeletal stiffness; Myalgia	FLU3~SANOFI PASTEUR~U1830AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248062	11/22/2005	MO	4.0	4		M	11/22/2005	Hives notes to left upper arm. Benadryl administered.				Y					Y	11/10/2005	11/10/2005	0		PVT	PVT						1						1	Urticaria	FLU3~SANOFI PASTEUR~U1867AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0287R~1~IM~LA~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0248063	11/22/2005	MO	5.0	5		F	11/22/2005	5 1/2 x 4 1/2 cm reddened, warm to upper left arm. No treatment with RX.				Y					Y	11/08/2005	11/10/2005	2		UNK	PVT	NONE	NONE	NONE			1						1	Erythema; Feeling hot	DTAP~SANOFI PASTEUR~C2254AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1862AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0287R~1~IM~RA~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~Y0460~4~SC~LA~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0579R~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0248064	11/22/2005	OH	51.0	50		F	11/22/2005	I received the shot at 9:00 AM and by 3:00 PM I felt hot and achy.  By 7:00 PM I had a fever of 102 and my joints were extremly sore.  I was shaking and could barely walk.  I had a terrible headache and was nauseous.  This was on Thursday.  The fever slowly dropped and abated by Saturday.  My normal teperature is about 96.  By Saturday I was back to 96 degrees and my joints were Ok by Monday.									Y	11/10/2005	11/10/2005	0		UNK	UNK	Uniphyll 400 mg, Cenestin .45 mg, Prilosec 20 mg, Topomax 600 mg, Verapamil 240 mg, Synthroid 100 mcg, Advair 100/50, Biotin 1000 mcg, Multi-vitamin		COPD, Hoshimoto's Disease			1						1	Arthralgia; Feeling hot; Headache; Nausea; Pain; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0248067	11/22/2005	VA	29.0	29		F	11/22/2005	This 29 year old patient received Nasal FluMist on Friday, 16 September 2005.  She awoke three days later unable to bend or move with pain and swelling to bilateral hands, fingers and back of her knees.  She reported welts covering her torso and extremities. She denied any fevers, chest pain, or breathing problems.  She was taken to Emergency Room 19 Sept 2005 5:33 am and treated with IV Solumedrol and Benadryl for an allergic reaction. She was released home with prednisone 50 mg PO x 4 days, Benadryl 50 mg PO every six hours as needed and Pepcid 20 mg one tablet twice a day for ten days. She reported some resolution of swelling/hives while using the Benadryl; however the hives returned with any cessation of her medication.  She followed up on 20 Sept 2005 9:00am advising her that her swelling had decreased with above medications however the itching persisted. Dr. noted macules and papules over the extremities and trunk with erythema and pruritus present.  Hydrocort Val (Westcort) topical 0.2% ointment was added to her above medications. This service member returned to work beginning to complain of feeling bad meaning fatigued, malaise, joint pain and felt a lump in her throat.  That evening she slept fitfully awakening early Wednesday morning wheezing, short of breath with tightness in her throat, and hives/welts all over her body.  She returned to Hospital 21 Sept 2005 and advised again it was an allergic reaction.  She was treated with another dose of Benadryl, Pepcid and IV Solumedrol She was instructed to continue home use of above medications. She followed up 22 Sept 2005 still with itchy rash/welts and joint pain/swelling for 4 days. This patieny stated there was a large purple bruise to palms of both hands, medial aspect both knees, which was swollen and tender to touch. There was no known trauma or recent illness. The physician noted reddish maculopapular pruritic rash/wheals over her arms, legs, back, chest, palms. She was diagnosed with dermatitis due to drugs and medicine (FluMist) and myalgia/myositis. Zyrtec and Darvocet were prescribed with prednisone increased to 60 mg x 3-4 days, and continued use of Benadryl prn, Motrin and Pepcid.  She was referred to the Vaccine Healthcare Center 28 Sept 2005 with concerns of a possible adverse event to the FluMist vaccine.  This patient continued to complain of severe (9-10/10) diffuse bilateral joint pain, persistent hives/rash to her torso and extremities and difficulty sleeping at night due to the pain. She reported no further bruising to her hands but stated swelling to her hands was worse every morning. The rash was described as multiple fine pale pink single macular pruritic rashes seen mainly in the morning to bilateral inner elbows, knees, back, and axilla. She still complains of a constant lump just under her cricothyroid membrane in her throat as if trying to swallow but can't get it to go down.  She denies any difficulty breathing, talking or swallowing. Laboratory studies include high CRP at 55.8 (normal 0-8) with a borderline positive ANA at 1:80 speckled.  Her rheumatoid factor was negative, CK was 22 and normal CBC, Chemistry, and urinalysis. As of 01 November 2005 she reported completion of prednisone. She continues to get controllable rashes and variable joint pain. She continues to follow up with her PCP for repeat labs and specialty referrals.				Y					U	09/16/2005	09/19/2005	3	10 Nov 2005 0954   ANA   SERUM BORDERLINE 1:80 SPECKLED (H)         ANA   SERUM POSITIVE: >/=1:80; Titer/Pattern to Follow (H)         C-Reactive Protein High Sensitivity       7.26         CK          54                       RF    SERUM <20                      RF    SERUM NEGATIVE                       ESR   WHOLE BLOOD, NOS  19                  28 Oct 2005 1456 Chlamydia LCX     ENDOCERVIX  NEGATIVE     GC LCX      ENDOCERVIX  NEGATIVE  29 Sept 2005 ESR       20 (nl high) at 1447; 12 at 0801 CRP/US    55.8 (0-8) ANA       Borderline 1:80 (speckled high) RF        negative CK        22 (l) Urine     clear, negative glucose, bili, ketone, blood, protein, nitrate.  TRACE leuk, pH 6.0, Spec Grav 1.024, urobil 0.2.  Microscopic: 1-3 WBC, epith 5-10,  CBC       WBC 6.9, RBC 4.76, HGB 14.7, HCT 43.0, Plt 344, RDW 11.5, PNM 63.20, lymphs 24.60, mono 7.0, eos 4.5, baso 0.70, Lipid panel Chol 209 (H), Trig 336 (H), HDL 65, LDL 77, VLDL 67 BMP         Ca 9.1, CO2 20, Cl 113 (H), Crea 0.8, glucose 80, K 4.5, Na 142, BUN 14, Anion gap 9 Hepatic panel Albumin 3.7, Bili 0.4, direct bili 0.1, Alk Phos 62, Total protein 6.9, ALT 20, AST 19, ratio 1.2  02 Sept 2005 Hemoglobin A1C  5.1 Free T4  0.97 TSH  2.167 CMP   Albumin 4.0, bili 0.7, Ca 9.1, CO2 23, Cl 108, Crea 0.9, glucose 89, Alk Phos 49, K 3.8, total protein 7.0, Na 139, ALT 34 (H), AST 26, BUN 12, Lipid panel  Chol 219 (H), trig 165 (H), HDL 57, LDL 129, VLDL 33 CBC  WNL	MIL	MIL	Zyban, alprazolam, Midrin, BCP, Lexapro, mvi	denies	migraines, tobacco cessation, anxiety,			1						1	Antinuclear antibody positive; Arthralgia; Contusion; Dermatitis; Dyspnoea; Fatigue; Headache; Hypersensitivity; Malaise; Oedema peripheral; Pruritus; Rash maculo-papular; Red blood cell sedimentation rate increased; Throat tightness; Urticaria; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0248068	11/22/2005	GA	59.0	59		F	11/22/2005	Redness, pain, swelling warmth around site of injection. Redness extends almost to rt. elbow. Movement of arm is difficult.Generalized tenderness to palpation. No cellulitis. Temp - 97.5. Tx: Pred Pack #1, Tylenol prn, warm compresses, Elidel cream, Clarinex, Benadryl HS. RTC in am.				Y					Y	11/09/2005	11/09/2005	0		UNK	UNK		N/A	N/A			1						1	Hypokinesia; Injection site erythema; Injection site hypersensitivity; Injection site pain; Injection site swelling; Tenderness	FLU3~SANOFI PASTEUR~U1910AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0513P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0248071	11/22/2005	MT	48.0	48		F	11/22/2005	Within 2 hours of vaccination, developed pain, redness and swelling (1/2 size of orange). Iced and used ibuprofen.This lasted 4-5 days. Pt later developed 5 small red lesions, each .5 cm with itching. No drainage/pus. Slow to heal, on 11/9/05, still had 3 lesions visible.									Y	10/21/2005	10/21/2005	0	None	UNK	UNK	unknown	none	no known allergies			1						1	Injection site erythema; Injection site pain; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U1832 BA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248072	11/22/2005	WI	39.0	39		F	11/22/2005	November 7th at 11:00 pm symptoms were itching on trunk of body,. Patient took oral Benadryl. November 8th at 8:00 am saw Dr. (unrelated consult) noticed hives on patient's stomach, back, buttocks, breast, lower abdomen, inner thighs.  Dr. told her to take 2 Benadryl every 4-8 hours.  Patient went home.  On November 9th, symptoms worsened.  Patient called primary MD on November 9th. Patient saw PA at 1:00 pm that day. Hydroxyzine HCL  50 mg tabs 1-2 tabs three times per day for rash. This medicine did help the rash and itching. On November 10th and 11th, patient developed sore throat and body aches. On the 10th, itching and hives returned. On the 12th, the itching and hives stopped.  On November 12th, lower abdominal pain started. Dr. (GYN) was seen on November 14th. Pelvic was done on patient as she had hysterectomy on 10/26.  Hives and itching returned associated with the abdominal pain in th evening of the 14th. Pelvic ultrasound (internal and external) on November 15th due to abdominal pain. Ultrasound was normal. On November 16th got stomach flu with nausea, poor appetitie, sharp abdominal pain. Diarrhea started on the 16th pm to early 17th am. On November 18th am went to Divine Savior ER, saw Dr., due to dehydration. Urine C/S and CBC were fine. One liter of IV fluids were administered and she went home. On November 18th pm, returned to ER because symtoms did not improve. Dr. saw patient. Two IV liters were given, Phenergan for nausea, Dilantin for the pain. Patient sent home on clear liquid diet. Prochlorperazine 5 mg for nausea was given previously for gastric bypass and MD approved continued use. On November 20th, feeling somewhat better, went to church. On November 22nd, still on liquids as solids upset stomach. Patient still has diarrhea with upset stomach.				Y					U	11/07/2005	11/08/2005	1	See number 7 above	UNK	UNK	Effexorxr 75 mg; Gabapentin 600 mg; Lorazepam 1 mg; Trazodone 100 mg; Levothyroxine 0.150 mg; ranitidine 150 mg; prochlorperazine 5 mg; prilosecotc 40 mg; vitamin daily; stool softener; Maalox prn	Hysterectomy on October 26, 2005. Patient was not ill on November 7th.	Allergic to Amoxicillin, Penicillin, Cephalosporins, Bioxin, Zithromax, Geodon. Gastic bypass Sept. 2003, diabetes prior to 2003. Meniere's disease started 1989. Irregular bleeding so hysterectomy was done.	Red ring around injection site~Tetanus Toxoid (no brand name)~~0.00~Patient		1						1	Abdominal pain; Decreased appetite; Dehydration; Diarrhoea; Nausea; Pain; Pharyngolaryngeal pain; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1838AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248073	11/22/2005	MT	22.0	22		F	11/22/2005	Within 2 hours of administration, developed redness, swelling and itching to area above injection site. Instructed to ice. Lasted for 3-4 days.									Y	11/15/2005	11/15/2005	0		UNK	UNK	unknown	none	none known			1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U1868AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248074	11/22/2005	CO	48.0	48		F	11/22/2005	Client received a flu and pneumonia vaccine in the same arm on the same day (12:30 pm).  At 7pm client noted extreme chills and aching. She went to bed and woke the next morning with a lump under her armpit, which was sore. Her arm also had a large reddened swollen area at the vaccine site. Over the course of the day she continued to feel awful with chills and aches. The next day she awoke with lumps along her clavicle and neck on the same body side as her immunizations. She presumed these to be enlarged lymph glands. She sought help at the local walk-in clinic. The physician diagnosed her with Shingles, even though she had no rash or skin eruptions in these areas. She was prescribed a drug costing $180 (name unknown) for shingles. She did not use it because she did not believe it was shingles. The lumps diminished over the next week and were gone by 8 days. The chills, aching, and malaise lasted 3 + days.				Y					Y	11/03/2005	11/05/2005	2	None	UNK	UNK	Lanoxin, Estrace, multi-vit	None	atrial fibrillation			1						1	Chills; Herpes zoster; Injection site erythema; Lymphadenopathy; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA 120 BA~3~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0604 R~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0248075	11/22/2005	MT	46.0	48		F	11/22/2005	24 hours after immunization, developed 7X8 cm reddened edematous itchy patch above injection site. Resolving after 72 hours.									Y	11/15/2005	11/16/2005	1	none	UNK	UNK	none known	none	had been on steroid treatment prior to immunization			1						1	Injection site erythema; Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~SANOFI PASTEUR~U1868AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248083	11/22/2005	OR	43.0	43		F	11/04/2005	Red, hot, swollen, upper arm, fever.									Y	11/01/2005				PVT	OTH	Singular;Advair;Wellbutrin	NONE	Asthma;Acid Reflux;Mitral Valve Prolapse			1						1	Erythema; Feeling hot; Oedema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61320~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0490P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248086	11/22/2005	CA	15.0	15		M		Immediate acute swelling of right deltoid area. Tender but non erythematous. Advised ice compress and Motrin. Vaccines received: Hep A and Meningococcal.										11/02/2005	11/02/2005	0		OTH	OTH		NONE				1						1	Swelling; Tenderness	FLU3~SANOFI PASTEUR~U1861AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0705R~1~IM~RA~HEP A (VAQTA)~1	USA		Influenza
0248087	11/22/2005	OR				F		Red, hot, swollen upper arm.									Y	11/01/2005				PVT	UNK	Altace;Toprol;Lipitor;Prilosec;Vivelle Dot;Diltiazem	NONE	HTN;Chronic Rhinitis;Esophageal Reflux;Mitral Valve Prolapse			1						1	Erythema; Feeling hot; Oedema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61320~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0490P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248095	11/22/2005	CO	15.0	15		M	11/07/2005	2 days post vaccine developed redness & pain at site - went to ER, differential diagnosis was vaccine reaction VS cellulitis ; tests included blood cultures and CBC ; had consult with infectious disease specialist and was treated with keflex X 14 days				Y					Y	10/24/2005	10/26/2005	2	WBC's , treated as cellulitis	PUB	PUB	singulair 5 mg, elavil 10 mg		sulfa allergy, chronic fatigue syndrome, asthma, depression			1						1	Cellulitis; Injection site erythema; Injection site pain; White blood cell disorder	FLU3~SANOFI PASTEUR~U1755AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0513P~1~SC~~PNEUMO (PNEUMOVAX)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B001AA~1~IM~~TDAP (BOOSTRIX)~1	USA	Emergency room visit	Influenza
0248115	11/23/2005	NY	42.0	41		F	11/18/2005	Initial report received on Nov 14 2005 from a consumer. A 41 year old female patient with a history of allergy to penicillin and whooping cough in Feb of 2005 was administered (route not reported) Fluzone SV 2005-2006 USP, lot number U17622A ( the lot number reported was not a valid lot number for the flu vaccine) in the left arm on Nov 11 2005 at 11:30am. At 13:30 that afternoon she experienced a severe coughing spell and was seen by a nurse. She took Benadryl liquid and the cough subsided but she had difficulty breathing. At 18:30 that evening she was seen in the ER and was treated with intravenous fluids and medications. The name, route and site of administration of medications used to treat these events were not reported. Blood work, urinalysis and a chest x ray were completed in the ER. The patient was release to go home that same evening. The patient had recovered from these events at the time of this report.				Y					Y	11/11/2005	11/11/2005	0		UNK	UNK			The patient had no illness at the time of the vaccination. Her pre existing medical history includes allergy to Penicillin and a past history of whooping cough in February of 2005.		200502499	1						1	Cough; Dyspnoea	FLU3~SANOFI PASTEUR~U17622A~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248117	11/23/2005		10.0			U	11/21/2005	MEDI 0003824 is a serious spontaneous case from a physician involving erythema multiforme. The reporter causality is probably not related to FluMist vaccine. A physician reported that a 10 year old child developed a rash 2 weeks after receipt of FluMist. The rash included the palms and was reported to be erythema multiforme. However, no mucosal involvement was reported. The reporter did not think this was related to FluMist. The patients clinical outcome is unknown. No other information is available at the time of this report. Important medical Event (OMIC).									Y					UNK	UNK					MEDI0003824	1						1	Erythema multiforme; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0248118	11/23/2005	VA	4.0	4		F	11/16/2005	11/12 Sat evening rash on buttocks, 11/13 Sunday rash on legs and ankles, 11/14 Monday ankles very swollen and behind knees, 11/14 Wed face rash, swollen lips, plus itching x 5 days. Call to RHHD then TO Dr. family has no insurance, was given order to place client in bath tub with baking soda and use Benadryl as needed.				Y					U	11/09/2005	11/13/2005	4	NONE	PUB	PUB	NONE		NONE		VA05020	1						1	Face oedema; Oedema; Pruritus; Rash	DTAP~SANOFI PASTEUR~DTPa639B2~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1746AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0343~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0151R~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0248119	11/23/2005	GA	48.0	48		F	11/16/2005	11/06-11/09/2005 fever, muscle aching, nausea, severe weakness, abdominal pain, dizziness, felt mentally strange, inappropriate behavior such as turning lamp on and lamp already on, flicking lights off and on.									Y	11/04/2005	11/06/2005	2	NONE	PUB	UNK	Synthroid, Diovan, Demadex, Toprol, Allegra, Singular.	None	Hypertension, Hypothyroidism, Myalgia, Chronic pyelitis,  Mean Venous Pressure, Sinusitis, Allergy.			1						1	Abdominal pain; Abnormal behaviour; Asthenia; Dizziness; Emotional distress; Myalgia; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~U1904AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248120	11/23/2005	MN	5.0	5		M	11/16/2005	11/16/2005 9:00am received vaccines (DTaP, OPV, MMR, Flu) 7:10 am started with tight coriza, 9:20 am hives started appearing 9:30 transport to ER via EMT.				Y					Y	11/16/2005	11/16/2005	0		PUB	PUB	Lasix, Allopurinol, Digoxin.	NONE	Congential heart defect with repair 12/08/2000 and 02/01			1						1	Rhinitis; Urticaria; Cough; Cyanosis; Dysphonia; Dyspnoea; Rash; Urticaria	DTAP~SMITHKLINE BEECHAM~DTPa633A2~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U0846AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0324~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~00312~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|DTAP~UNKNOWN MANUFACTURER~~UNK~~~DTAP (NO BRAND NAME)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~2|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~2	USA	Emergency room visit	Influenza
0248121	11/23/2005	OR	40.0	40		F	11/18/2005	2 or 3 days after injection left arm started hurting felt tingling and numbness in left arm and 3 fingers and is slowly getting worse. TC to Employee health 11/11/2005 stated maybe hit nerve ant to see my doctor.									U	11/02/2005	11/04/2005	2		UNK	UNK						1						1	Hypoaesthesia; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U1818AB~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248122	11/23/2005	NJ	33.0	32		F	11/18/2005	11/11/05 shot administered, 11/12/05 pm felt itchy took Benadryl for 24 hours, 11/13/05 lips, face, swollen, blotchy, ED steroids Benadryl, 11/14/05 worse blotches, 11/16/05 PMD Zantac, Zyrtec given, 11/17/05 felt worse saw allergist possible Naprosyn reaction.				Y					Y	11/11/2005	11/12/2005	1	NONE	OTH	OTH	Synthroid, Naprosyn, Lexapril	NONE	Had allergy testing in past no DX			1						1	Face oedema; Hypersensitivity; Pruritus; Rash macular	FLU3~SANOFI PASTEUR~UIB25BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248123	11/23/2005	WI	1.01	1	.0	F	11/18/2005	MMR vaccine administered 11/08/2005, mom noted rubeoliform rash on trunk, slightly noted on extremities and face.				Y					Y	11/08/2005	11/18/2005	10		PVT	OTH						1						1	Rash	FLU3~SANOFI PASTEUR~U1743MA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0452R~3~IM~RL~HEP B (RECOMBIVAX HB)~1|MMR~MERCK & CO. INC.~0769R~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08637E~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0248124	11/23/2005	MI	68.0	68		F	11/20/2005	10/17 light headed, slight headache began, 10/21 temp 99.4, sleeping more naps, 10/22 severe diarrhea onset 4am diarrhea has continued to this day. uniformed stools, hyperactive bowel stimulated every time I eat or drink. Unimproved diarrhea for one month. Treated with Pepto Bismol, Loperamide, BRAT diet, fluids with electrolytes. Diagnosed as post injection inflammation.									N	10/12/2005	10/22/2005	10	Stool cultures x 3 negative for bacteria, OVA and parasite.	PVT	PVT	Lisinopril, Trazodone, Ibuprofen, Multi Vitamin	NONE	Hypertension, History colon polyps.	Diarrhea~Influenza (Seasonal) (no brand name)~~0.00~Sibling		1						1	Diarrhoea; Dizziness; Headache; Pyrexia; Somnolence	FLU3~AVENTIS PASTEUR~U1753AA~UNK~IJ~AR~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248125	11/23/2005	MI	60.0	59		F	11/23/2005	Patients daughter reported that her moms tongue, lip and face swelled up. Patient was a little short of breath. She took Claritin and the swelling went down a little. Next morning pt was better but still had slight swelling.									Y	11/22/2005	11/22/2005	0		OTH	OTH						1						1	Dyspnoea; Face oedema; Tongue oedema	FLU3~SANOFI PASTEUR~U1839AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248126	11/23/2005	IL	64.0	64		F	11/21/2005	Beginning the day after she received vaccine, patient complained of her arm being very sore. As of Monday, Nov. 21 ( 1 week later ), she stated her arm was still very sore. She contacted MD but had not heard back yet.									U	11/14/2005	11/15/2005	1		OTH	OTH						1						1	Pain	FLU3~SANOFI PASTEUR~U1866AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248127	11/23/2005	CA	50.0	50		F	11/23/2005	Redness, swelling where the shot was given, soreness, aches. Hoarseness, wheezing, hives ( mild ) Shot was given on 11/15/05 I still have									N	11/15/2005	11/15/2005	0		OTH	UNK			Allergies, asthma			1						1	Dysphonia; Injection site erythema; Injection site oedema; Pain; Urticaria; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0248136	11/23/2005	VA	58.0	58		M	11/23/2005	numbness and pain (4 on pain scale) of left arm started in lower arm 20 minutes after receiving injection.				Y						11/22/2005	11/22/2005	0		UNK	UNK			allergic to Motrin			1						1	Hypoaesthesia; Pain	FLU3~SANOFI PASTEUR~u193AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248137	11/23/2005	OK	51.0	50		F	11/23/2005	Hives over entire body about 14 hours after shot administered. Called the Stillwater emergency room and was told to take (2) Benedryl and watch for indications of breathing trouble or swollen eyes. Rash stayed about 48 hours but hives and itching ceased by morning.									Y	11/18/2005	11/19/2005	1		UNK	UNK		None	High Blood Pressure take Atenol			1						1	Pruritus; Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0248138	11/23/2005	CT	83.0	83		F	11/23/2005	Patient received her flu vaccine at a Flu Clinic by our organization. She went home and then at noon felt very tired. She laid down and fell asleep. She felt this was unusual. In the afternoon she got up to get ready for a benefit. She went to the benefit early evening. Symptoms happended within 30 minutes of arriving. She ate something then vomited and passed out. They transported her via ambulance to ER. She was evaluated and released. She called me on Thursday. I interviewed her on Friday and she felt fine. I told her I would submit the report to you and she may be called for more information. She has received flu vaccines in the past with no problems.				Y					Y	10/25/2005	10/25/2005	0		UNK	UNK		None				1						1	Fatigue; Loss of consciousness; Vomiting	FLU3~SANOFI PASTEUR~U1764AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248139	11/23/2005	CT	84.0	83		F	11/23/2005	Patient came to a Flu Clinic. She received the shot approximately at 11:00am. In 15 minutes she felt funny, not right, out of it. She complained of a headache and numbness in upper part of face which spread to lower face. BP was 144/80 then changed to 184/84, 190/84, 194/86 as she sat there for one hour with monitoring. Pulse was irregular (70s-80s). Her physicians where called promptly. Her medical physician was not in but her cardiologist called us back. The physician decided to have the patient go to his office at 3pm. I called the patient in the evening and the next day and she said she felt fine at this point. She slept well during the night. Doctor thoroughly evaluated her. She did not receive any medication treatments.				Y					Y	11/09/2005	11/09/2005	0		UNK	UNK						1						1	Blood pressure increased; Headache; Heart rate irregular; Hypoaesthesia; Malaise	FLU3~SANOFI PASTEUR~U1836AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248140	11/23/2005	MS	71.0	70		F	10/19/2005	ITCHING & REDNESS AROUND SITE OF VACCINATION STARTING DAY OF ADMINISTRATION 10/14/2005. PT STATED SHE HAD THE SAME REACTION LAST YEAR.  STATES EGGS MAKE HER SICK.									Y	10/14/2005	10/14/2005	0	NONE	UNK	UNK					MS05022	1						1	Injection site erythema; Injection site hypersensitivity; Pruritus; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U1806AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248141	11/23/2005	IL	5.0	5		M	11/23/2005	Patient had generilized rash with wheezing and decreased oxygen saturation.				Y	Y	1			Y	11/22/2005	11/22/2005	0		UNK	UNK	Pulmicort, ALbuterol, Prevacid	cerebral palsy	cerebral palsy, Bacitracin/polymyxin, Sulfonamides, Ketorolac, midazolam			1						1	Hypoxia; Rash; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0248142	11/23/2005	NC	36.0	36		F	11/23/2005	Patient with newly diagnosed MS admitted to neurology service 11/16 pm because for about two weeks patient has had numbness of the left upper thigh and left lower abdomen as well as recent history of numbness and clumsiness of right arm post flu shot given on 11/4/05.   There is a distinct cold sensation.  Patient admitted 11/16/05 for steroid therapy for presumed MS flare possibly precipitated by flu shot.				Y	Y	2			Y	11/04/2005	11/05/2005	1		UNK	UNK	flaxseed, progestin	None	Pre-eclampsia, pre-term labor 2 years ago, Rhinitis			1						1	Clumsiness; Condition aggravated; Feeling cold; Hypoaesthesia	FLU3~AVENTIS PASTEUR~U1764AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0248153	11/23/2005	ID	72.0	72		M	11/23/2005	10 days after flu injection, client experienced pain in upper chest, neck and back. Thought he was experiencing a heart attack. Taken by ambulance to hospital - was seen by cardiologist. Viral pleurisy was diagnosed. Condition was resolved 48 hours later. Pt. released and given Rx of protonix 40 mg BID.				Y					Y	11/10/2005	11/20/2005	10	EKG - normal results Blood work (unknown tests or results)	PUB	PVT	maginex, protonix, diovan, toprol, lipitor, dextromethazine		Heart condition - stent place 8 years ago, pacemaker 1 year ago			1						1	Myocardial infarction; Pain; Pleurisy	FLU3~SANOFI PASTEUR~U1904AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248163	11/23/2005	IA	52.0	52		F	11/23/2005	BRIGHT RED, HOT TO TOUCH, AT INJECTION SITE HEADACHE									Y	11/22/2005	11/23/2005	1	NONE	UNK	UNK	NONE	NONE	HAY FEVER, DETERGENTS, CERTAIN JEWELRY, FRAGRANCES	NAUSEA~Influenza (Seasonal) (Fluvirin)~1~0.00~In Patient		1						1	Headache; Injection site erythema; Injection site warmth; Similar reaction on previous exposure to drug	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61501~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0248165	11/23/2005	FL	36.0	35		F	11/23/2005	Onset within 10 minutes of vaccination beginning with vertigo without nausea, and numbness of tongue.  At no time was there any difficulty breathing or heart palpitations.  This progressed over a 2 hour period to include numbness of body with pain in shot arm.  It felt like I was shot up with novicaine everywhere and pain down my (left)arm and my left hand felt like it was smashed.  Client spoke with her physician by phone but was not seen.  The numbness and discomfort lasted approximately 24 hours.  This was followed by malaise for another 48 hours.  When contacted November 2, 2005, client stated that she felt completely recovered.  At no time did she check her temperature.									Y	10/27/2005	10/27/2005	0	none	UNK	UNK	multivitamin	none	none			1						1	Hypoaesthesia; Injection site pain; Malaise; Vertigo	FLU3~SANOFI PASTEUR~U1904AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248166	11/23/2005	UT	1.13	1	.1	M	11/23/2005	Fever; crying; large, red welt at sight of injection.  Mom stated that the child cried all night and had a fever.  She stated that she had had a reaction to Tetanus when she was young.									Y	11/22/2005	11/22/2005	0	none	UNK	UNK	NONE	NONE	NONE			1						1	Crying; Pyrexia; Similar reaction on previous exposure to drug; Urticaria	DTAP~SANOFI PASTEUR~C2254AA~3~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1754AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE610AA~3~IM~LL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~Y0496-2~3~SC~RL~POLIO VIRUS, INACT. (IPOL)~1|PPV~MERCK & CO. INC.~A56117A~3~IM~RL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248167	11/23/2005	MA	11.0	11		M	11/23/2005	Redness and tenderness noted around injection site 2 days after immunization.  Brought in for eval.  No streak, fever, or nausea.  Exam showed poorly demarcated area of erythema without warmth.  Small area of tenderness with slight induration about 1cm in size central to erythematous area.  No other tenderness.  No significant adenopathy.										11/21/2005	11/23/2005	2		UNK	UNK		none	none			1						1	Injection site erythema; Injection site induration; Injection site pain	FLU3~SANOFI PASTEUR~U1823AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B002AA~1~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0248168	11/23/2005	CA	1.25	1	.3	M	11/23/2005	Developed acute cerebellar ataxia 36 days after varivax and MMR were administered, with vomiting and wide-based unstable gait.  CT scan of the brain was normal, patient was observed with no medication or further intervention				Y					U	10/17/2005	11/22/2005	36	CT brain - negative	UNK	UNK	singulair, xopenex, pulmicort	none	reactive airways disease, beginning 12/04			1						1	Cerebellar ataxia; Gait disturbance; Vomiting	FLU3~SANOFI PASTEUR~U1807AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0293R~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0626R~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0248170	11/23/2005	TN	13.0	12		F	11/23/2005	Immediately after receiving the Fluviron, she fainted and hit her head on the floor.				Y					Y	11/23/2005	11/23/2005	0		UNK	UNK	Concerta 56mg, Tagamet 200mg					1						1	Injury; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62445~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0248174	11/24/2005	MN	67.0			M	11/24/2005	Diagnosed with Guillan-Barre.  Improved after IVIG therapy. Discharge summary states pain in legs, abnormal gait. msv					Y	3			Y		11/22/2005		Elevated CSF protein 96 with 3 nucleated cells. inconclusive nerve conduction studies.  Pt received influenza vaccine within 4 weeks of developing sx consistent with GBS. Discharge summary states lab tests abnormal. msv	UNK	UNK		none	none Discharge summary states degenerative bone disease. msv			1						1	CSF test abnormal; Gait disturbance; Guillain-Barre syndrome; Laboratory test abnormal; Pain in extremity	FLU3~AVENTIS PASTEUR~U1838AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0248178	11/25/2005	CT	70.0	69		F	11/25/2005	Crimson spot @ site and 2x3 erythemtous macular reaction.									Y	11/16/2005	11/16/2005	0		UNK	UNK		none				1						1	Erythema; Injection site erythema	FLU3~SANOFI PASTEUR~u1850aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248179	11/25/2005	CT	49.0	48		F	11/25/2005	Large area of erythema - 9x8 and induration 8/10. Benadryl 50 mg po, patient had taken Ibuprofen 800 mg 1 hour prior to being seen. She describes getting similar rxn to dT in past.									Y	11/16/2005	11/16/2005	0		UNK	UNK		None admitted		yes~DT Adsorbed (no brand name)~1~0.00~In Patient		1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~u1850aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248180	11/25/2005	FL	60.0	60		M	11/25/2005	Received Vacination around 2:30 PM Tuesday Nov 22,2005. About 8:30 PM I started having chills, fever and loss of energy, and bad headaches, followed by aches and pain. Symptoms continued until approxamately 8AM on Nov. 23 2005, except for the loss of energy which I still have, but not as severe.									U	11/22/2005	11/22/2005	0		UNK	UNK						1						1	Asthenia; Chills; Headache; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0248182	11/25/2005	OH	1.27	1	.3	M	11/25/2005	Patient developed rash consistent with Varicella on 10/14/05.  Patient had a diffuse papular rash that was itchy.  There had been no known exposure, but the distribution made me suspicious of Varicella.  I only treated with Zyrtec for symptom relief and he did well as far as I know.				Y					U	12/01/2004	10/14/2005	317	none	UNK	UNK	none	none	none			1						1	Pruritus; Rash; Rash papular	FLU3~SANOFI PASTEUR~U1442AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1191N~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A57553F~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0649P~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0248184	11/27/2005	WA	66.0	66		M	11/27/2005	pt was hospitalized with cellulitis and on iv No new terms added from Discharge Summary rec'd 12/28/2005/sr				Y	Y	2			Y	11/23/2005	11/23/2005	0	not back from dr siler as of this date	UNK	UNK		NONE KNOWN AT THE TIME	NONE			1						1	Cellulitis	FLU3~SANOFI PASTEUR~U1865AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1048P~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0247515	11/28/2005	MN	64.0	64		F	11/22/2005	11-07-05 Vaccine. 11-08-05 - Noted redness, swelling, discomfort in right arm injection area, returned to Minute Clinic in pm and was checked by CNP on duty. She checked with her supervisor and then ordered Doxycycline orally. Took one and then could see that redness, etc. was progressing. Called internist on call that evening who advised me to take another Doxycycline and see Dr. in am if running a temp or feeling worse. That night, started running a 101 F temp, had severe shaking chills, felt very ill. Next morning went in to see Dr. who admitted me to hospital with cellulitis of right arm. 11-9-05 Admitted to hospital about noon and received Levaquin IV at 6 pm WBC at clinic 16,000+ and neutrophils elevated. Area about 6 cm by 8 cm and pain. 141-10-05 Right arm cellulitis progressing, temp down, received Levaquin IV at 6pm. Much pain in right arm area. 11-11-05 Cellulitis still progressing and antibiotic changed to Clindamycin IV every six hours. Feeling ill no appetite. 11-13-05 Progression of cellulitis continued Began to develop very itchy skin rash on trunk of body. Changed to Vancomycin IV every 24 hours. skin rash getting worse, and moderate diarrhea, hyperactive bowel sounds, very poor appetite. 11-14-05 Skin rash progressing and covering most of body, diarrhea continued. Cellulitis contained. 11-15-05 Home from hospital on oral Levaquin allergic skin reaction, etc. worse. 11-17-05 To clinic to see Dr. for severe itching and discoloration and darkening of skin on trunk, diarrhea. Taken off all antibiotics, cellulitis not progressing any more, pain less. Intense discomfort of skin. Antihistaminic prescribed. 11-18-05 Followup clinic visit - Finally not feeling worse. 11-22-05 As of this date, some discoloration of skin on trunk, mild rash on legs and arms, occasional episodes of itching, large area on right upper arm discolored, but no pain, redness. Still some digestive system upset, but appetite is returning. This is a record of the illness to the best of my memory of events.b joints 1/1/10 follow up- moderate arthritis in hips, feet & thumb joints;allergic to cipro;taking cipro for uti; strain of e. coli became resistant to cipro. also had mild itching of face.			Y	Y	Y	7			N	11/07/2005	11/08/2005	1		PUB	PUB	HCTZ;Inderal L.A.;Fluoxetine 20 mg;Nexium		Keflex;EES;Septra DS			1						2	Anaemia; Arthritis; Diarrhoea; Drug interaction; Drug level decreased; Injection site erythema; Injection site induration; Injection site pain; Leukocytosis; Pain; Rash; Vomiting; Anorexia; Cellulitis; Chills; Diarrhoea; Gastrointestinal sounds abnormal; Injection site erythema; Injection site swelling; Limb discomfort; Malaise; Pain in extremity; Pruritus; Pyrexia; Rash; Skin discolouration; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA141AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1006P~1~SC~RA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~SC~RA~PNEUMO (PNEUMOVAX)~2	USA	Life Threatening,Hospitalisation	Influenza
0248154	11/28/2005	NJ	1.67	1	.7	M	11/25/2005	Child experienced fever, passed out. Mother took her to ER. Child's temp in ER was 104.8. Redness at site on right arm				Y					Y	11/21/2005	11/21/2005	0	CBC with diff in ER results normal 11/23/05 UA - results pending	PVT	PUB	Augmentin, albuterol					1						1	Injection site erythema; Loss of consciousness; Pyrexia	DTAP~SANOFI PASTEUR~C2325AA~4~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1904AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0129P~3~IM~LA~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~A98341K~2~IM~RA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0248155	11/28/2005	OH	76.0	75		F	11/11/2005	Arm was red and warm to touch. Has taken antibiotics since then ( 11/07/05 ) and redness has gone away after two days									Y	11/07/2005	11/07/2005	0	had pneumonia vaccine in 2004. Patient unaware.	OTH	PUB						1						1	Erythema; Skin warm	FLU3~SANOFI PASTEUR~U1869AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0815P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248158	11/28/2005	NC	70.0	70		F	10/18/2005	Reddened and itching area approx 6 cm diameter at injection site.									Y	10/16/2005	10/18/2005	2		PUB	UNK						1						1	Hypersensitivity; Injection site erythema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0248185	11/28/2005	NY	45.0	45		M	11/28/2005	Fluttering in the chest Nausea, Emesis Chest Tightness Shortness of Breath Lightheadedness				Y	Y	1			Y	11/08/2005	11/08/2005	0	Cardiac Enzymes negative ECG Negative CXR Normal	MIL	MIL	None	None		Flu like, cold sweats, joint pain~Influenza (Seasonal) (no brand name)~~0.00~Patient		1						1	Atrial flutter; Chest discomfort; Dizziness; Dyspnoea; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0248186	11/28/2005	NY	36.0	35		M	11/22/2005	Initial report received on Nov 10 2005 from a consumer. A 35 year old male patient with a history of depression had received an intra muscular injection of Fluzone SV 2005 2006 USP, lot number U1823AA, in the right deltoid, his first subcutaneous injection of YF VAX, lot number UE664AB, in the right arm, his first intra muscular injection of another manufacturers Pneumovax vaccine, lot number 0749P, in the left deltoid and his first intra muscular injection of Menactra, lot number U1812AA, in the right arm on Nov 2 2005 at 16:00. Ten hours later he woke up with a temperature of 101 degree F that increased to 104.8 deg F. he went to the ER were he was treated with IV fluids and Tylenol. Blood test were performed. He was then sent home. The next day on 11/04/2005 at 16:00 he experienced nausea, blacking out, and back pain, He again went to the ER where he had additional blood test and a lumbar puncture. He was sent home with a prescription of Vicodin, He was on bed rest from 11/05/2005 to 11/08/2005 and was seen by the physician on 11/08/2005 at 10:00 am. On 11/09/2005 he was admitted to the clinic for infectious diseases and per the reporter, was diagnosed with yellow fever. Additional information and hospital records were received on 11/11/2005. Per the reporter, as of 14:45 on 11/10/2005 the patient was doing better and will be discharged to home from the clinic on 11/10/2005. The reporter stated that the patients predominant symptoms were sever headaches and neck pain with pain in his eyes. He was also sensitive to light. She stated that for the first two visits to the emergency room the patient was told it was probably a reaction to the flu vaccine and was told to rest and take Tylenol. She stated the patient was diagnosed at the clinic as having a mild case of yellow fever and was now feeling better since they controlled the pain.  Hospital records received on 11/11/2005 indicated the patient was admitted to the hospital on 11/09/2005 with a complaint of headache that was occipital in nature with no radiation with pain and pressure behind his eyes. He had not had any episodes of blurred vision. His pain started the morning of 11/3/2005 along with a fever. The patients wife stated that the patient had syncopal episode on Friday 11/04/2005 in the ER possibly related to hyperventilation. The patient stated the headache was not getting better. His alleviating factors included lying down and avoiding light. The aggravating factors included moving and light. Physical Neurological examination was negative. Laboratory data was reported as follows (date of laboratory work not reported), white blood count 7.8, platelet count 283, hemoglobin 15.7, hematocrit 43.9, sodium 137, potassium 3.1, chloride 102, bicarbonate 25, blood urea nitrogen 9, creatinine 1, glucose 110, calcium 9.4, international normalized ratio 0.99, partial thromboplastin time 32.1. Lumbar puncture completed in the ER on 11/04/2005 revealed normal cerebrospinal fluid. The patient had an Anesthesia consult that ruled out a spinal headache, and a neurology consult that ruled out any neurological component to the headache. He had a magnetic resonance imaging scan that was normal with no acute changes which would suggest etiology of the headache. His diagnosis was headache most likely due to post viral encephalitis or post spinal tap. The patient refused to leave the hospital and wanted to be admitted. He was admitted for observation and was started on Robaxin 750 mg four times a day, potassium chloride CR 20 mEq, Norco 10/135 mg as needed. He had blood cultures taken, sedimentation rate, liver function test and Prothrombin time. The patient had a Infectious Disease consult on 11/10/2005. It was reported that twelve hours after the vaccination on 11/02/2005 the patient developed occipital headaches and was admitted to the hospital with a high grade fever of 104.0 deg F. The fever de-effervesced itself. His headaches were attributed to post lumbar puncture headache. The patient was treated on 11/09/2005 with additional medications of Motrin and Metoclopramide. The recommendation of infectious disease was that the patient could be sent home with reassurance that his headache will resolve in one week, these symptoms are most likely due to yellow fever vaccination. The patient was advised to take off from work for one week to ten days. He was told if his headaches persisted beyond one week he should see his neurologist for a serum patch to treat post spinal tap headache. His liver function test was found to be mildly elevated which can be secondary to vaccination. The patient was discharged in stable condition, afebrile and with pain under control. The discharge medications were Motrin 400 mg by mouth three times a day and wean off as needed. Metoclopramide 5 mg by mouth before meals and at bedtime as needed and Norco 325.5 mg one tablet by mouth every six hours as needed. The patient was to follow up with his primary care physician in one week. Further information obtained via telephone call with the physician on 11/11/2005 reveals that the patient was not diagnosed with the disease yellow fever. He was diagnosed as Adverse reaction to vaccine. The physician states the cerebral spinal fluid results were no cells present. It was reported that the patient's recovery status was described as fine with a little remaining headaches.					Y	0			N	11/02/2005	11/03/2005	1	Laboratory data was reported as follows (date of laboratory work not reported), white blood count 7.8, platelet count 283, hemoglobin 15.7, hematocrit 43.9, sodium 137, potassium 3.1, chloride 102, bicarbonate 25, blood urea nitrogen 9, creatinine 1, glucose 110, calcium 9.4, international normalized ratio 0.99, partial thromboplastin time 32.1. Lumbar puncture completed in the ER on 11/04/2005 revealed normal cerebrospinal fluid.	OTH	UNK	Effexor		The patient had no illnesses at the time of the vaccination. He has a history of depression and was taking Effexor, 50 mg daily at the time of the vaccination. Medical records received on 11/11/2005 stated that on the advise of the patients primary care physician, the patient was asked to discontinue the Effexor. The date of discontinuation is not reported. The patient was taking no other medications at the time of vaccinations. Per the reporter, the patient did not have any other vaccinations within four weeks prior to these vaccinations. Per the medical records the patient has no allergies. It is unknown if the patient had any previous doses of the Fluzone vaccine.		200502412	1						1	Activated partial thromboplastin time prolonged; Back pain; Blood calcium increased; Blood glucose increased; Blood potassium decreased; Encephalitis; Eye pain; Headache; Hyperventilation; Liver function test abnormal; Loss of consciousness; Nausea; Neck pain; Photophobia; Pyrexia; Sensation of pressure; Syncope	FLU3~SANOFI PASTEUR~U1823AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1812AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PPV~MERCK & CO. INC.~0749P~1~IM~~PNEUMO (PNEUMOVAX)~1|YF~SANOFI PASTEUR~UE664AB~1~SC~RA~YELLOW FEVER (YF-VAX)~1	USA	Hospitalisation	Influenza
0248189	11/28/2005	MD	52.0	52		M	11/21/2005	Initial report received from a health care provider on Nov 16 2005. A 52 year old male patient with a medical history of migraines received a left deltoid injection of Fluzone SV 2005-2006, lot number U1772AA, on 10/13/2005. Route of administration was not reported. On approximately 11/11/2005, the patient developed numbness and tingling in his hands and feet that moved up the extremities and muscle weakness. On 11/14/2005, the patient was examined in an ER, and thereafter, admitted to the hospital. Admitting diagnosis was not reported. The results of a CT and MRI were unknown. At the time of this report, the patient continued to be hospitalized and not recovered.					Y	0			N	10/13/2005	11/11/2005	29		UNK	UNK			The patient had a history of migraines. Illness at the time of vaccination was none. Other medications were unknown.		200502480	1						1	Hypoaesthesia; Muscular weakness; Paraesthesia	FLU3~SANOFI PASTEUR~U1772AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0248190	11/28/2005	HI	0.67	0	.7	F	11/22/2005	Seriousness criteria other medically significant (OMIC), Initial report received from another manufacturer, report number WAES0511USA00146, on 11/9/2005. A nine month old female patient received in the left thigh a second dose of Fluzone SV 2004-2005, lot number U1381AA, on 4/29/2005. The patient had a history of facial rash and eye discharge, and her mother was vaccinated varicella virus vaccine, while pregnant. One month post vaccination, on 5/29/2005, the patient developed a fever, runny nose and sneezing. She was treated with acetaminophen. On 6/01/2005, the patient developed a rash on her body which was sparse and erythemous on the trunk. On 6/02/2005, the patients appetite was slightly decreased. On 9/22/2005, the patient developed a fever of 102 deg F, and on 9/28/2005, the patient experienced a febrile seizure and urinary tract infection. C reactive protein was high and positive at 9.2 mg/dl. Microscopic urine analysis showed bacteria to be many. Urine culture from a catheterized specimen showed greater than 100,000 cfu/ml of Escherichia coli. The patient was treated with cephalexin, acetaminophen, and ibuprofen. The patient was directed to be examined by her physician the following day. On Oct 1 2005, it was noted that the patient had not had a fever for more then 24 hours, she was urination well, and her activity was normal, On Oct 2 2005, a urine culture was repeated, although results were not reported. Imaging was to be done in one month. On Oct 11 2005, it was reported that the patient had been constipated for one day. She was afebrile and had completed the cephalexin. On Oct 26 2005, it was noted that the patient was constipated and had developed a fever on and off for four days. The patient's vaccination history included, on Oct 29 2004, a first dose of IPOL, lot number X1006, given in the right thigh, a first dose of Daptacel, lot number C1996AA, given in the left thigh, a first dose of Prevenar , lot number 495721, given in the left thigh and a first dose of Comvax, lot number 648422/0091P, given in the right thigh. Vaccinations received on 12/10/2005  include a second dose of Daptacel, lot number C2104AA, given in the right thigh, a second dose of ACTHIB (dose one was a different product), lot number UE335AC given in the left thigh, and a second dose of Prevnar, lot number A7400E, given in the right thigh. Vaccinations received on Jan 28 2005 include a third dose of Daptacel, lot number C2131AA, in the left thigh a second dose of IPOL, lot number X1189, given in the left thigh, a second dose of Comvax, lot number 6481423/0128P, given in the right thigh, and a third dose of Prevnar, lot number A557562B given in the right thigh. Vaccination received on Mar 29 2005 include a third dose of Hepatitis B virus vaccine dose one and two were Comvax, lot number 647593/0465P, given in the left thigh and a first does of Fluzone SV 2004-2005, lot number U1381AA, given in the right thigh. Following these events, the patient was subsequently vaccinated with a left thigh injection of Fluzone SV 2005-2006, lot number U1754AA, On 10/11/2005. Adverse events experienced by the patient after this vaccine are reported in non serious case 200502514. At the time of this report, the patients recovery status was unknown.				Y					U	04/29/2005	09/28/2005	152	Sept 28 2005 C reactive protein positive at 9.2 mg/dl Microscopic urinalysis many bacteria. Urine culture from catheterized specimen greater than 100,00 cfu/ml of Escherichia coli.	UNK	UNK			The patient had a history of facial rash and eye discharge. The patients mother was vaccinated with varicella virus vaccine while pregnant.		200502398	1						1	Bacterial infection; Constipation; Decreased appetite; Febrile convulsion; Laboratory test abnormal; Pyrexia; Rash; Rash erythematous; Rhinorrhoea; Sneezing; Urinary tract infection	FLU3~SANOFI PASTEUR~U1381AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248193	11/28/2005	PA	58.0	57		F	11/23/2005	A 57 year old female patient with no significant medical history, and who had received the flu vaccine for the past three years with no reaction, had received an intramuscular injection of Fluzone SV 2005-2006 USP, lot number U17622AA, in the left arm in 02/Nov/2005 at 12:15 pm. the next day the patient developed a headache that became more severe in nature on04/Nov/2005. ON 04/Nov/2005 she developed swelling in her hands, arms, legs and ankles. This was accompanied by pain the the joints. She went to the ER and was treated with steroids. The patient had recovered from these even at the time of this report.				Y					Y	11/02/2005	11/03/2005	1		PUB	PVT					200502497	1						1	Arthralgia; Headache; Joint swelling; Oedema peripheral	FLU3~SANOFI PASTEUR~U17622AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248194	11/28/2005	OH	47.0	47		M	11/23/2005	Initial report received on 11/17/2005 from a health care professional. A 47 year old male patient with a history of passing out when giving blood, had received an intramuscular injection of Fluzone SV 2005-2006 USP, lot number U1911AA, site not reported, on Nov 17 2005. Within minutes, his color turned green, his eye rolled back in his head and he became unconscious. the patients blood pressure 90/60 and he was sent to the ER for evaluation. Per the reporter, the patient did not have hives or difficulty breathing. The status of his recovery as the time of this report was not reported.				Y					U	11/17/2005	11/17/2005	0	The patients blood pressure was taken and it was 90/60.	UNK	UNK	Vitamins		Patient has a history of passing out when giving blood. The patient has not had any other vaccinations within four weeks prior to the date of this vaccination.		200502506	1						1	Blood pressure decreased; Eye movement disorder; Loss of consciousness; Skin discolouration	FLU3~SANOFI PASTEUR~U1911AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248196	11/28/2005	NC	9.0	9		F		A nurse from a doctors office reported that a 9 year old female, with no previous medical history, experienced fever, cough and cough out blood, 4 days after she received FluMist vaccine on Oct 28 2005. On Nov 1 2005, the patient began to have fever. On Nov 2 2005, the patient felt worse and was coughing so much that she cough out a glob of blood. She was seen a physician who ordered that the patient use a mist tent. Per the reporter, as of Nov 10 2005, the patients mother has not called the doctors office nor has she brought patient back for follow up. The patients clinical outcome is unknown at the time of report. The reporter causality is not provided.				Y					Y	10/28/2005	11/01/2005	4		PVT	OTH	Concomitant drugs not reported				MEDI0003815	1						1	Cough; Haemoptysis; Malaise; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~503386P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0248203	11/28/2005		59.0	59		M	11/22/2005	Information has been received from a medical assistant concerning a 59 year old white male who on Nov 9 2005 was vaccinated IM with 0.5 ml dose of pneumococcal 23 polysaccharide vaccine (lot 650084/0605P). the patient also received influenza virus vaccine (unspecified) on the opposite arm. Concomitant therapy included salmeterol xinafoate (severent) and albuterol sulfate (+) ipratropium bromide (Combivent). On Nov 9 2005, the patient developed allergic reaction. On Nov 10 2005, the patient came to the clinic and was treated with antibiotics. The patient was reported as recovered. Allergic reaction was considered to be an other important medical event by the reporting medical assistant (OMIC). Additional information is not expected.									Y	11/09/2005	11/09/2005	0		OTH	OTH	Combivent, Serevent				WAES0511USA02980	1						1	Hypersensitivity	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0605P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248215	11/28/2005	SC	85.0	85		F	11/18/2005	Information has been received from a respiratory therapist concerning a female (age not provided) who on 10-Nov-2005 was vaccinated IM with 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot # 649988/0629P). The patient also received influenza virus vaccine (unspecified) on the opposite arm. No reaction to the influenza virus vaccine was reported. On 10-Nov-2005, the patient developed a little swelling and heat at the injection site. Two hours later the entire arm was swollen and she was unable to drive. She was told by the physician to go to the emergency room (ER). On 11-Nov-2005, a friend drove her to the ER and she was treated there. The patient's outcome was not reported. A little swelling and heat at the injection site and swollen arm were considered to be other important medical events (OMIC) by the reporting respiratory therapist. There was no product quality complaint involved. The respiratory therapist also provided information regarding another patient's experience with pneumococcal 23v polysaccharide vaccine (WAES #0511USA01974,0511USA02334). Additional information has been requested.					Y				Y	11/10/2005	11/10/2005	0		OTH	OTH					WAES0511USA02335	1						1	Hypokinesia; Injection site warmth; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0692P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0248220	11/28/2005	PA	3.0	3		M	11/21/2005	Around 8:30 pt started with vomiting and c/o severe headache and what felt like buzzing bees in his head. Mom said his eyes were funny looking and was taken to ER where doctors had a hard time waking him up. Pt was then admitted. Per annual report-Reporter states possible diagnosis is pediatric migraine. No 2nd dose of flu vaccination will be administered.  Hospital report requested from Medical Center.  2/1/06 Review of medical records (neuro consult) Final impression: probable pediatric migraine, nothing suspicious for seizure.					Y	1			Y	11/18/2005	11/18/2005	0	12/15/05 - Per review of medical records CXR was negative. 2/1/06 - Per review of medical records (neuro consult) CT scan was negative.	PVT	PVT	NONE		DTAP  vaccine-hives	~DTaP (no brand name)~4~2.00~In Patient		1						1	Depressed level of consciousness; Eye disorder; Headache; Migraine; Similar reaction on previous exposure to drug; Vomiting	FLU3~SANOFI PASTEUR~U1777AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0248221	11/28/2005	IN	54.0	54		M	11/17/2005	Approximately 40 minutes after injection, patient returned to area where shots were being administered. He was very short of breath, pale, and diaphoretic. Complained of SOB and throat swelling. 911 was called immediately. Benadryl 50mg IM and EPI 1:1000 .3 SQ was administered immediately. Patient's symptoms improved prior to ambulance arrival. Patient transported to nearest hospital.   12/22/05 Reviewed medical records. Additional symptoms include flushing, nausea, chest pain, and felt faint/lightheaded. Treated with NTG, phenergan, morphine, and Lovenox (antithrombotic).				Y	Y	2			Y	11/02/2005	11/02/2005	0	12/22/05-Per review of medical records, troponins were negative.	OTH	PVT			Diabetes; HTN; Hyperlipidemia 12/22/05 - Per review of medical records, there is PH of CAD resulting in CABG surgery and stent placement.			1						1	Dizziness; Dyspnoea; Flushing; Hyperhidrosis; Nausea; Pallor; Pharyngeal oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA125AC~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0248222	11/28/2005	CT	78.0	78		F	11/22/2005	Received 0.5ml Fluzone on 10/19/05. 10/20/05, experienced a non MI cardiac event with cardiomyopathy. Discharge summary states myocarditis, diaphoresis, nausea. msv				Y	Y	6			U	10/19/2005	10/20/2005	1	Discharge summary states abnormal EKG, abnormal lab tests. msv	PUB	PUB	UNK		Discharge summary states hypertension, hypercholesteremia, diatetes mellatis. msv			1						1	Cardiomyopathy; Electrocardiogram abnormal; Hyperhidrosis; Laboratory test abnormal; Myocarditis; Nausea	FLU3~SANOFI PASTEUR~U1778AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0248223	11/28/2005	CO	33.0			F	11/21/2005	Patient received FluMist. As she was driving home, she felt like she was going to pass out two times. Each lasted a few seconds, but patient had to pull over until the episode passed. (OMIC)									Y	11/18/2005	11/18/2005	0		UNK	UNK						1						1	Dizziness	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0248249	11/28/2005	CA	40.0	39		F	11/22/2005	Per patient, Rash to left upper arm appeared 24 hours following flu shot. Rash warm to touch, and itchy. Seen in Emp Health on 11/18/05; diffuse rash to abdomen, a febrile, with rash to left arm from shoulder to elbow. Denies other S/S.									Y	11/15/2005	11/16/2005	1		PVT	PVT	Denies	NONE				1						1	Feeling hot; Pruritus; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U1865AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248250	11/28/2005	IA	52.0	51		F	11/22/2005	2 hours after vaccine given came to health office complaining of itching at site. Redness, edema and warmth present.									Y	11/07/2005	11/07/2005	0		OTH	UNK						1						1	Hypersensitivity; Injection site erythema; Injection site oedema; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U1830AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248251	11/28/2005	FL	50.0	49		F	11/22/2005	Flu vaccine given at 3 pm. 4 pm noted itchy around right side of neck. Given Benadryl 25mg PO and then took Benadryl 25mg PO on arrival at her home. 5:00 pm call to employee, home safe, no further redness.									Y	11/22/2005	11/22/2005	0	NONE	PUB	UNK		NONE	Sensitive to adhesives			1						1	Erythema; Pruritus	FLU3~SANOFI PASTEUR~U1935AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248252	11/28/2005	HI	43.0	43		M	11/18/2005	About 8 hours after immunization, patient noted fever up to 104 degrees (oral), chills and headache. Also note red rash at immunization site. Sx improving using Tylenol.									Y	11/16/2005	11/16/2005	0	NONE	PVT	PVT		NONE	NONE			1						1	Chills; Headache; Injection site erythema; Injection site rash; Pyrexia	FLU3~SANOFI PASTEUR~U1754AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248253	11/28/2005	CT	58.0	58		F	11/17/2005	Approx 24 hrs after receiving Fluzone injection; pt developed a strawberry-type rash that appeared to look like windburn. very pruritic. Area effected included injection site left deltoid, left face, neck and hairline. Pt denied any respiratory compromise or hives; denied fever. Benadryl topical helpful in alleviating itch. All S/S resolved 24 hrs after onset.									Y	11/10/2005	11/11/2005	1		PVT	PVT			Allergies: Codeine;Tylox;Macrobid			1						1	Injection site reaction; Purpura	FLU3~SANOFI PASTEUR~U1869AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248254	11/28/2005	UT	71.0	71		F	11/20/2005	Dark purple bruise at administering site, extreme swelling and redness around the site, tithing and tenderness. Administered on Nov 17th symptoms on Nov 18th. Dr visit on Nov 21 - medication prescribed by Dr.				Y					U	11/17/2005	11/18/2005	1		OTH	UNK		NONE	NONE			1						1	Contusion; Hypersensitivity; Injection site erythema; Injection site reaction; Injection site swelling; Pruritus; Tenderness; Erythema	UNK~UNKNOWN MANUFACTURER~~UNK~~~VACCINE NOT SPECIFIED (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1808AB~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0248255	11/28/2005	PA	80.0	79		F	11/23/2005	Pneumovax administered 11/21/05 in left upper arm. Received a phone call from patient on 11/22/05 that her arm was stiff and sore. Was advised to apply cold compresses for 48 hours. On 11/23/05 presented to office. Arm was significantly  red fro elbow to axilla area - completely around but not involving injection site area. Hot to touch. Most pronounce redness and heat was ulnar aspect above antecubital area at hands breadth in size.									Y	11/21/2005	11/22/2005	1	NONE	PVT	PVT	HCTZ;Fosamax;Multivitamins;Calcium +D;Celebrex (Dc'd 2 days before inj)	NONE	Arthritis;HTN			1						1	Erythema; Feeling hot; Musculoskeletal stiffness; Myalgia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~60214~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1047P~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248256	11/28/2005	AR	52.0	51		F	11/18/2005	Within 2 hours of receiving vaccine in left deltoid begin having neck pain and stiffness. Nuchal rigidity lasted over 24 hours. 11/21/05 now reports 2 days of weakness in arm.									Y	11/15/2005	11/15/2005	0	NONE	PUB	PVT		NONE	NONE			1						1	Asthenia; Musculoskeletal stiffness; Neck pain; Nuchal rigidity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61503~6~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0248257	11/28/2005	RI	4.0	4		M	11/22/2005	Right leg swelling, redness through out thigh.				Y					Y	11/17/2005	11/18/2005	1		PUB	OTH		NONE	Local Allergy to mosquito bites			1						1	Erythema; Swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14A011AA~UNK~~~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1804AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1240-2~UNK~~~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0232R~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0248258	11/28/2005	ND	39.0	39		F	11/21/2005	Onset of coughing 2 hrs post injection lasted 45 minutes, report build up of spectrum used inhaler 2 times with relief. Reports previous response with allergy shots. 11/22 completely better.									Y	11/21/2005	11/21/2005	0	NONE	OTH	OTH	Inhaler	NONE	Asthma			1						1	Cough	FLU3~SANOFI PASTEUR~U1861AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248259	11/28/2005	TX	44.0	44		F	11/14/2005	Nausea, shortness of breath, instructed patient to call 911, EMS saw patient, patient refused transport to hosp. Saw her own doctor.				Y					U	11/12/2005	11/12/2005	0		OTH	PVT		Nasal Congestion	NONE			1						1	Dyspnoea; Nausea	FLU3~SANOFI PASTEUR~U1817AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248260	11/28/2005	OR	56.0	56		F	11/21/2005	Pain from neck, shoulder and upper arm. Shot was given in shoulder. I have used ice, heat and Tylenol. I am still having problems.									N	11/16/2005	11/16/2005	0	NONE	PVT	PVT		NONE	Allergic to dust and mold			1						1	Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0248261	11/28/2005	CT	22.0	21		F	11/17/2005	Per mother approx 24 hrs after receiving Fluzone injection, pt developed a strawberry type rash that looked like wind-burn that was very pruritic. Involved area included injection site left deltoid, left face, neck and hairline. No respiratory involvement or compromise, no fever. Benadryl topical very helpful in alleviating itch. All S/S resolved 24 hrs after onset.									Y	11/04/2005	11/05/2005	1		PVT	PVT		NONE	Allergy Codeine			1						1	Haemangioma of skin; Injection site reaction; Rash pruritic	FLU3~SANOFI PASTEUR~U1869AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248262	11/28/2005	CA	23.0	23		F		Became very itchy after the shot.									Y	11/21/2005	11/21/2005	0	NONE	PVT	PVT						1						1	Pruritus	FLU3~SANOFI PASTEUR~U1825CA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248264	11/28/2005	PA	12.0	11		F		Local Rx right deltoid given Td and influenzae on 11/15/05 - tender, swollen 4 x 2; no erythema, normothermia to palp injections were spaced 1/4 apart. Examined by myself on 11/17/05. Tx Q.I.D. Ibuprofen; Keflex 500 one PO B.I.D.									Y	11/15/2005				PVT	UNK	NONE	NONE	NONE			1						1	Oedema; Tenderness	FLU3~SANOFI PASTEUR~U1753AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~AVENTIS PASTEUR~U1619BA~6~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0248265	11/28/2005	NE	79.0	78		F	11/23/2005	Individual reports pain at time of injection and return following AM. Individual reports left arm continues to hurt when using it or wt bearing. Denies any redness or swelling at site at site at any time- Physician thought tendon or ligament was inflamed - Rx'd Celebrex but individual refused to take due to concerns re side effects.				Y					U	10/07/2005	10/08/2005	1	NONE	OTH	PVT	Dyazide, Protonix, Fosamax, Zetia, Multiple Vitamin	NONE	Mild HBP, arthritis, hx bleeding ulcer 5 years ago			1						1	Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA120AA~7+~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0248266	11/28/2005	CA	0.84	0	.8	F	11/04/2005	Child had immunizations at 10 AM 11/2/2005 - Fever started at 10:30 PM according to the ER on 11/03/2005 - Was 10:56 when they arrived in the ER at 4 am 11/4/2005 - CBC, BI culture done.				Y					Y	11/02/2005	11/03/2005	1	CBC, Blood culture done 11/4 - 11/5 seen for VT Id treated with Ceftmax zone.	PVT	PVT	Hemophoylsis					1						1	Pyrexia	FLU3~SANOFI PASTEUR~U1816AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB185AB~UNK~IM~RL~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0248268	11/28/2005	CT	82.0	82		F	11/28/2005	Rash on the body noted 11/15/2005 2 days after Flu shot and Pneumovax were given. New order; Benadryl q 6 hours PRN. Hydrocortisone to rash resolved 11/18/2005.									Y	11/13/2005	11/15/2005	2		OTH	UNK		Has very poor appetite. Not eating.				1						1	Rash	FLU3~SANOFI PASTEUR~U1900AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0748P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248269	11/28/2005	NY	42.0	42		F		Weakness, tiredness and sleepy x 1 day.									Y	11/18/2005				PUB	UNK						1						1	Asthenia; Fatigue; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0248270	11/28/2005	PA		73		M	11/23/2005	Nurse did not swab site of injection before administration. Eyes became irritated and got progressively worse as if had stones in them; left eye had swelling and redness on left corner, right eye also irritated. Washed eyes; had some relief and went to sleep. later on noticed that had swelling on both eyes (bags on eyes) especially top lid of left eye. Puffiness on top and bottom lid reduced. Right now has watery eyes.									N	11/22/2005	11/23/2005	1		MIL	MIL	Prolosev	NONE	NONE			1						1	Eye irritation; Eyelid oedema; Ocular hyperaemia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0248271	11/28/2005	KS	30.0	30		F	11/28/2005	Employee's first influenza vaccine to date. CDC info sheet on influenza inactivated vaccine given and discussed. Employee denied sulfate allergy. Vaccine administered accordingly. Onset of tachycardia (130), increased BP, dizziness, and pale within 5-10 minutes of administration. Employee monitored on floor by co-workers. No medication given. Employee did not notify provider until 11/28/05 at 09:45. Advised employee not to take flu vaccine again.			Y						Y	11/22/2005	11/22/2005	0		PVT	PVT			Asthma; Allergy to sulfa			1						1	Blood pressure increased; Dizziness; Pallor; Tachycardia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62217~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening	Influenza
0248272	11/28/2005	MN	63.0	62		F	11/28/2005	Facial rash thick, red, burning.									Y	11/09/2005	11/12/2005	3	ne ESR, weak Pos <1.40 ANA, Pos RF (past).	OTH	PVT		NONE				1						1	Antinuclear antibody positive; Rash; Rash erythematous; Skin burning sensation	FLU3~SANOFI PASTEUR~U1761AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248273	11/28/2005	PA	46.0	45		F	11/28/2005	Approximately 2.5 to 3 hrs after vaccination, I started having trouble breathing with coughing and wheezing. (I was diagnosed as suffering from an asthma attack about 10 years ago after prolonged exposure to small dust particles from construction.  I have 1-2 incidents a year that require me to use an inhaler.)  At approximately 6 to 6:30p.m. I used the inhaler and gradually obtained relief beginning after about 20-30 minutes of using the inhaler. I did alert the nurse at the Health Unit where I work and where the vaccine was administered.  She noted that the time elapsed strongly supported the view that it was not a reaction to the vaccine and did not believe I needed to fill out this form and recommended I contact my doctor. I believe it was a reaction and submit it only for any value it may have in terms of tracking/evaluating. Thank you.									Y	11/21/2005	11/21/2005	0		UNK	UNK	none	none	see No. 7 above			1						1	Asthma; Cough; Dyspnoea; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0248274	11/28/2005	CT	74.0	73		M	11/28/2005	Patient complained of very red itchy site. Site had small white spot in the center surrounded by red itchy area 4-6mm in size. No pain or swelling. He showed area to his own doctor he was told he should still have the flu shot next year. Patient is concerned he would have an anaphlactic reaction next year. He is a retired Dr. At this time white spot is present redness is getting smaller. All this is as reported by patient.									Y	10/29/2005	10/31/2005	2		UNK	UNK	Combivent, HCTZ, Atenelol, Vitamins, Coumadin, Cosar, Fosamax	None	Asthma, environmental allergies, sea bass,			1						1	Erythema; Pruritus	FLU3~SANOFI PASTEUR~U1815AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248275	11/28/2005	MA	54.0	54		M	11/28/2005	Erythema, pruritis, warm to touch in an area 4 X 5 around the injection site. MD recommended OTC Diphenhydramine cream which was effective in decreasing symptoms.									Y	11/18/2005				UNK	UNK	Prilosec, Singular, Allegra, combivent, flovent, Flonase		Asthma			1						1	Injection site erythema; Injection site hypersensitivity; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U1872AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248276	11/28/2005	FL	71.0	70		M	11/28/2005	Reports pain and heat at injection site with swelling for 2 days after the injection. Pain radiated from top of left forearm to ring and middle finger of left hand. Took ASA for Pain.									Y	11/16/2005	11/16/2005	0	none	UNK	UNK	Unkown	Unkown	Allergic to PCN			1						1	Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1872AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0745P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248277	11/28/2005	MI	0.88	0	.9	M	11/28/2005	The most serious concern that took us to the emergency room, was his excellerated heartbeat and breathing along with his weakness and inability to walk.  He was given the vaccine approx. 10 am the morning of 11/25/05, and by noon, after he awoke his morning nap, he couldn't walk without falling down, and cried constantly for almost 24 hours.  Over the course of the day, he breathing became heavier and faster and his heart felt like it was going to explode.  His body was very lifeless and because of the weakness in his legs, required us to carry him constantly for almost 2 days.  He was taken to the ER at approx. 5:30 am on the 26th and sent home diagnosed as side effects of the vaccine.  Push liquids and tylenol for discomfort.  Today is Monday, although he's feeling better, he is still very weak and irritable.				Y					Y	11/25/2005	11/25/2005	0	Chest xray to rule out possiblity of pneumonia, bronchitis etc.	UNK	UNK		mild cold	none known			1						1	Dyspnoea; Feeling abnormal; Gait disturbance; Heart rate increased; Irritability; Muscular weakness	FLUX~UNKNOWN MANUFACTURER~~1~~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0248278	11/28/2005	MN	12.0	12		M	11/28/2005	Mother called today. States son received FluMist 5 days ago, he has rash noted this am.  Rash is from head to toe, red dots, stomach most noted to be blotchy.  States no fever.									U	11/22/2005	11/28/2005	6		UNK	UNK	multi vitamins	none noted	none noted			1						1	Rash; Rash macular	FLUN3~MEDIMMUNE VACCINES, INC.~500389p~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEP~MERCK & CO. INC.~0958p~2~IM~LA~HEP B (RECOMBIVAX HB)~1	USA		Influenza
0248279	11/28/2005	TX	3.0	3		F	11/28/2005	seizure				Y					U	10/29/2005	10/29/2005	0		UNK	UNK		none				1						1	Convulsion	FLU3~SANOFI PASTEUR~u1814aa~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248281	11/28/2005	ME	56.0	56		F	11/28/2005	Approximately 4 hours post influenza vaccine developed persistent cough (lasting 3 hours), oral mucosal edema, sudden itchy eyes. Subsequently this patient described near anaphylaxis with respiratory involvement and angioedema.									Y	11/07/2005	11/07/2005	0	N/A	UNK	UNK		None known	Subsequent to vaccine, she concluded she must be allergic reaction to thimeresol due to history of itchy eyes with contact lens solution. Declined thimeresol allergy prior to vaccine.			1						1	Angioneurotic oedema; Conjunctivitis; Eye irritation	FLU3~SANOFI PASTEUR~U1912AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248284	11/28/2005	TX	1.18	1	.2	M	11/11/2005	Vaccine administered 11/7/05. Onset of vesicular lesions lower trunk and groin 11/11/05. T 99.5 seen by MD and given Rx for Atarax on 11/11/05.				Y					Y	11/07/2005	11/11/2005	4		PVT	PUB	NONE	NONE	Blind due to optic nerve atrophy;History of large Kidney due to reflux		TX05098	1						1	Skin ulcer	FLU3~SANOFI PASTEUR~U1817AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0302R~1~~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0637R~1~~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0248307	11/28/2005	CA	4.0	4		F	11/10/2005	Erythema 50mm x 25mm noted by mother 08/10/05. States applied cool ice compresses and gave Tylenol. Mild slight swelling noted when presented in office. Child has no difficulty moving arm. Advised to administer Benadryl cream or cortisone cream to sight, or give oral Benadryl and or Tylenol for discomfort.									Y	11/08/2005	08/10/2005			PUB	PUB	NONE	NONE	NONE			1						1	Discomfort; Erythema; Oedema	DTAP~SMITHKLINE BEECHAM~AC14A010BA~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1818AB~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB076~4~IM~RA~HEP B (ENGERIX-B)~1|HEPA~MERCK & CO. INC.~0287R~1~IM~RA~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~Y0241~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0232R~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0248321	11/28/2005	NE	49.0	49		F	11/28/2005	24 hrs after receiving vaccine, the patient developed Bell's Palsy affecting the right side of her face.				Y						11/18/2005	11/19/2005	1	Negative CT/MRI scan	UNK	UNK		None	None			1						1	Facial palsy	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61122~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0248282	11/29/2005	NY	35.0	35		M	11/29/2005	Smallpox vaccine administered 21Nov05. Initial read 28Nov05 was normal reaction. Returned today 29Nov05, now with approximately 2 inch diameter area on Rt Deltoid, localized swelling, warmth, pain. Decreased Shoulder ROM secondary to pain. Pt c/o Chills. Treatment with OTC Tylenol at present and continue to observe site. F/U PRN.									U	11/21/2005	11/29/2005	8		MIL	MIL	Benadryl	None	Possible allergy to fruit preservative.			1						1	Chills; Hypokinesia; Injection site oedema; Injection site pain; Injection site warmth	ANTH~EMERGENT BIOSOLUTIONS~FAV107~1~SC~LA~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~50387P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~PFIZER\WYETH~4020072~1~~RA~SMALLPOX (DRYVAX)~1	USA		Influenza
0248330	11/29/2005	PA	75.0	75		M	11/29/2005	Guillain Barre Syndrome start 11/14/05. Started with blurred vision, dysphagia, nausea. Discharge summary states amblyopea, cerebrovascular disease, dizzy, dehydration, NPN increased, peripheral vascular disease.  Discharge summary states ischemic cerebrovascular disease, abnormal gait.					Y	10	Y		U	11/08/2005	11/14/2005	6	Discharge summary states abnormal lab tests.  Medical records state hyponatremia.	PVT	PVT	Triglycerine; HCT; Diovan		HTN; Hyperlipidemia; Cataract Medical records state coronary artery disease.			1						1	Cerebral ischaemia; Dehydration; Dizziness; Dysphagia; Gait disturbance; Hyponatraemia; Laboratory test abnormal; Nausea; Vision blurred	FLU3~SANOFI PASTEUR~U1903AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0248335	11/29/2005	TN	60.0	60		M	11/23/2005	11/16/05 3AM, Muscles in arm and chest tightening up and into chest - breathing hurt chest to back. Could not take a deep breath without excruciating pain. To ER. Admitted for 2 days. Cardiac work up; no cardiac problems. Muscle were like rocks.				Y	Y	2			Y	11/15/2005	11/16/2005	1		PUB	UNK	Monopril; Cardizem CD		Hypertension			1						1	Chest discomfort; Dyspnoea; Muscle rigidity; Pain	FLU3~SANOFI PASTEUR~U1838AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0248337	11/29/2005	OK	4.0	4		M	11/29/2005	Patient recieved his vaccines at approx. 4:15 PM. After leaving the clinic he developed hives and difficulty breathing at approx. 4:50 PM. They returned immediately to the clinic where he was noted to have generalized urticaria, wheezing and respiratory distress. Color appeared somewhat dusky. He was immediately given .2ml Epinephrine SQ and 25mg benadryl IM with rapid improvement in symptoms. Patient was then transferred to the emergency room for further observation.			Y	Y					Y	11/28/2005	11/28/2005	0	Vital signs(after epinephrine) T 98.4/P 113/R 28/ BP 100/48/ Pulse Ox 93%	UNK	UNK	Claritin Syrup, Albuterol Inhaler	None	Asthma, Allergic Rhinitis, Eczema			1						1	Cyanosis; Dyspnoea; Respiratory distress; Urticaria; Wheezing	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B006AA~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1929AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0496~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0330R~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Life Threatening	Influenza
0248339	11/29/2005	VA	28.0	28		F	11/29/2005	1.25 hours after receiving flu vaccine, noticed redness at site, pruritis of neck and arms.  No SOB, no angioedema.				Y					Y	11/21/2005	11/21/2005	0		UNK	UNK		None	Post-partum depression, well treated with Zoloft.  MD diagnosed allergy to sulfa.			1						1	Angioneurotic oedema; Dyspnoea; Injection site erythema; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62445~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0248342	11/29/2005	IL	47.0	46		F	11/29/2005	Mainly local reaction--swelling, redness, heat around injection site.  Lasted 5 days.  Had malaise, low grade fever for 2 days.									Y	10/31/2005	11/01/2005	1		UNK	UNK	HRT, effexor, pravachol	none	high cholesterol, menopause			1						1	Injection site erythema; Injection site oedema; Injection site warmth; Malaise; Pyrexia	FLU3~PARKDALE PHARMACEUTICALS~~5~IM~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0248343	11/29/2005	OH	58.0	57		F	11/29/2005	The client notified Health District on 11/29/05 of her symptoms after receiving her flu shot on 11/18/05. She is experiencing a throbbing pain in her right arm and shoulder. She describes it as a constant throbbing pain that persists regardless of any OTC pain relievers that she has taken. Client states that she has taken the flu shot in the past without incident. She has been advised to follow up with her family physician.									N	11/18/2005	11/19/2005	1		UNK	UNK	n/a	Client had finished antibiotics for and upper respiratory infection.	Allergic to codeine			1						1	Pain	FLU3~SANOFI PASTEUR~U1815AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248344	11/29/2005	IL	60.0	60		F	11/29/2005	Within four days of administration I developed  the following a) hot swollen painful knuckle joint, left hand b) vaginal yeast infection c) hives on left arm c) headache, mild, began evening on day I received the injection and continued through the following day d) aura similar to that of classical migraine: some numbing and tingling in left foot and around the lips									U	11/22/2005	11/22/2005	0		UNK	UNK	Allegra 180 mg Cardizam 180 Premarin .3 mg Nexium Asthma inhalers		Anti phosphalipid sydrome, anticardiolipin possible Reynaud's  allergy to Molds,dustmite, Molds exertional Asthma Migraine Headaches, by history(now infrequent) GERD			1						1	Arthralgia; Feeling hot; Fungal infection; Headache; Hypoaesthesia; Joint swelling; Paraesthesia; Urticaria	FLUX~UNKNOWN MANUFACTURER~unknown~2~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0248345	11/29/2005	ME	68.0	67		F	11/29/2005	Patient reported a sore right arm since the flu shot on 11/4.  Has been seen by her family doctor and told that it was a local reaction and to ice it and use tylenol as needed.				Y					N	11/04/2005	11/04/2005	0		UNK	UNK		none reported				1						1	Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA148AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0248346	11/29/2005	OH	36.0	36		F	11/29/2005	Full body raised red rash, (except face). Diffuse large papules covering buttocks, arms, legs, chest and back. Referred to dermatologist who prescribed steroid therapy, both parental and oral.									Y	11/14/2005	11/21/2005	7	skin culture done by dermatologist, results pending	UNK	UNK	prenatal vitamins 1 daily. Synthroid 0.05 mg daily	none	no allergies. Hypothyroid			1						1	Rash erythematous	FLU3~SANOFI PASTEUR~AF1UA154AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248348	11/29/2005	ND	54.0	53		M	11/29/2005	On 11-26-05 arm broke out in a red, raised, itchy rash.  Arm sore.  On 11-28 rash down to elbow.  On 11-29 a few raised areas to his wrist.  Instructed to take Benadryl.  IF worsens, see MD.									U	11/21/2005	11/26/2005	5	none obtained	UNK	UNK	None	None	None			1						1	Rash erythematous; Rash pruritic	FLU3~SANOFI PASTEUR~U1881AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248350	11/29/2005	VA	4.0	4		M	11/29/2005	Mom reported moderate edema, redness in right thigh morning after injection date, edema increased by 24hrs post injection to knee. No fever reported, child was fussy. Motrin was given by mom and ice applied. 7pm on Day 2 edema involved entire thigh to knee and surrounding knee with redness. 9:30pm Day 2 redness had begun to decrease edema the same mom was giving Benadryl. child up walking and playing. Day 3 only slightly swollen and no redness. Day 4 very little edema, no redness child functioning normally.										11/23/2005	11/24/2005	1	N/A	UNK	UNK						1						1	Erythema; Oedema	DTAP~GLAXOSMITHKLINE BIOLOGICALS~Ac14A0098A~5~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1863AA~5~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1240~4~SC~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0612P~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0248351	11/29/2005	CA	4.0	3		M	11/29/2005	Firm upper arm circumference increase redness,itches 19cm erythema shoulder to elbow									Y	11/23/2005	11/25/2005	2	none	UNK	UNK						1						1	Erythema	FLU3~SANOFI PASTEUR~U1848AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248352	11/29/2005	ID	1.16	1	.2	F	11/29/2005	23 Nov had flu vaccine, 25 Nov developed emesis, no fever.  Emesis resolved by 26 Nov. 27 Nov had a few minute seizure at home, shortly afterwards had another seizure that did not resolve until tx in ER with Ativan and another anti-seizure medication (records not available).  Patient did not have a fever before, during or after seizure.  Transferred to PICU, normal spinal tap, MRI, EEG.  Etiology of seizure undetermined per neurologist. Medical records state otitis, sleep disorder.				Y	Y	2			Y	11/23/2005	11/27/2005	4	MRI, EEG Medical records state hyperkalemia, leukocytosis, increased AST.	MIL	MIL	Pedialyte	emesis, malaise Medical records state rhinorhea.	34 week premature delivery otherwise well child with normal development			1						1	Aspartate aminotransferase increased; Convulsion; Hyperkalaemia; Hyponatraemia; Leukocytosis; Otitis media; Sleep disorder; Vomiting	FLU3~SANOFI PASTEUR~U1916AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0248353	11/29/2005	WA	43.0	43		M	11/29/2005	Cellulitis in the left arm where influenza and pneumoccocal vaccines given				Y					Y	11/18/2005	11/19/2005	1	None	UNK	UNK	Lisinopril, Metformin, Lovastatin	None	Type II DM, Hypertension, Hyperlipidemia, fatty Liver			1						1	Cellulitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61319~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0570905~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0248354	11/29/2005	OH	52.0	52		F	11/29/2005	Right arm weakness, severe pain of right arm with internal and external rash; pain to touch triceps and deltoid muscles.				Y					U	10/31/2005	11/01/2005	1		PVT	PVT	Avonex;Varivax Prn;Vitamins	Multiple Sclerosis	Allergies: PCN;Keflex;Sulfa;Levaquin;Urised;Macrodantin			1						1	Muscular weakness; Pain; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61123~5~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0248355	11/29/2005	NY	76.0	75		F	11/21/2005	11/11/05 presented at emergency room with c/o fever, chills, and cough. Symptoms started 2 days after receiving influenza vaccine from County health. Admitted for dehydration and further observation. Questionable reaction. Discharge summary states bronchitis. msv				Y					Y	11/04/2005	11/11/2005	7	CBC - white count elevated 11-1 19;neutrophil 6 bands;hemoglobin 13.7;hematocrit 39-9;potassium 2.3;glucose 227. All others within normal limits.	PUB	PUB		NONE	Allergy to Sulfa Discharge summary states osteoporosis, ischemic cerebreum. msv			1						1	Blood gases abnormal; Blood glucose increased; Blood potassium decreased; Bronchitis; Chills; Cough; Dehydration; Haematocrit decreased; Haemoglobin decreased; Pyrexia	FLU3~SANOFI PASTEUR~APU1747AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248356	11/29/2005	NJ	10.0	10		F	11/18/2005	0.5 cc Fluzone given about 6:15 pm  - no known allergies. Child 1st time for flu vaccine, stated feeling fine. Parent at side for question. Asked to sit 5-10 minutes after few minutes stated felt ok and ready to leave., child got pale, diaphoretic. B/P 94/70 P 64, supine and increase legs. After 15 minutes color good, pulse 80 and strong, B/P 96/78. Went home with mother referred to family physician for any questions.									Y	11/17/2005	11/17/2005	0		PUB	UNK		NONE			NJ200113	1						1	Hyperhidrosis; Pallor	FLU3~SANOFI PASTEUR~U1936AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248357	11/29/2005	NY		82		F	11/21/2005	Received flu and pneumonia on 11/15/05 clinic. By evening, redness, pain, swelling, SOB on Thursday. Antibiotic and Benadryl prescribed.				Y					Y	11/15/2005	11/15/2005	0		PUB	UNK	Premarin; Zantac	NONE				1						1	Dyspnoea; Erythema; Pain; Swelling	FLU3~SANOFI PASTEUR~U1912AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0746P~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0248358	11/29/2005	TX	23.0	23		M	11/15/2005	Multiple lesions/rashes throughout the upper arms bilaterally, the back, the neck, the trunk, and bilateral hip trexor areas. The genitalia and lower extremities, plus face and forearms diagonally  had no reaction or rashes.									Y	10/26/2005	10/27/2005	1		UNK	UNK	NONE	NONE	NONE			1						1	Rash; Skin ulcer	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA131BA~UNK~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0248359	11/29/2005	CA	65.0	64		M	10/28/2005	Pt received two vaccinations of flu. Pt did not display any untoward symptoms										10/02/2005				PUB	PUB					CA050078	1						1	Unevaluable event	FLU3~SANOFI PASTEUR~1844AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248360	11/29/2005	IL	11.0	10		M	11/25/2005	Fever 103, chills and sweats, dizziness - hallucinating. Gave Tylenol and Ibuprofen. Reported symptoms to primary care doctor. They instructed me to watch and call if not resolve within 24-48 hours.									Y	11/21/2005	11/21/2005	0	NONE	PUB	OTH		NONE				1						1	Chills; Dizziness; Hallucination; Hyperhidrosis; Pyrexia	FLU3~SANOFI PASTEUR~U1881AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248361	11/29/2005		47.0	46		F	11/04/2005	Pt received the influenza vaccine 2005-2006 - Fluvirin - 0.5 ml IM at 12:10 11/3/05. At 13:30, she felt dizzy, spots in vision, itchiness - to nose, throat, chest, facial redness, and SOB. She received 25mg diphenhydramine.  At 17:00 pt complained of weakness, dizziness. She receive fluid and felt much better.										11/03/2005	11/03/2005	0		UNK	UNK			She receive the influenza vaccine last year.			1						1	Asthenia; Dizziness; Dyspnoea; Erythema; Pruritus; Visual disturbance	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61123~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0248363	11/29/2005		55.0	55		F	11/13/2005	Pt adm for low back pain. Had right total hip replacement about 2 wk prior to admission and influenza vaccine about 3 wk prior to adm. After adm developed numbness in hands and feet and progressive generalized weakness. Also had to have pulmonary consult and was put on BiPAP. Neurologist stated Guillain Barre Syndrome most likely diagnosis. Medical records state pt tx w/plasmapheresis & include Urinary tract infection, bradycardia, fatigue, nausea, bacterial infection.					Y	15	Y			11/01/2005			CSF culture - negative;CSF bacterial antigen neg;Rheumatoid factor neg; Hep A,B & C neg;HIV neg;ANA neg;CMV AB,IgG - positive 3.25 Medical records anemia, leukocytosis, abnormal CSF w/protein 158(H).	UNK	UNK			Pt had son with H/O Guillain Barre Syndrome Medical records state OA, migraine, hyperlipedemia, anxiety, allergy. Right THR 10/05, left THR 2003.			1						1	Anaemia; Asthenia; Bacterial infection; Bradycardia; CSF test abnormal; Fatigue; Guillain-Barre syndrome; Hypoaesthesia; Leukocytosis; Nausea; Urinary tract infection; Asthenia; Back pain; Difficulty in walking; Dyspnoea; Hypokinesia; Laboratory test abnormal; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U177AA~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0248364	11/29/2005	WA	54.0	53		F	11/18/2005	Approx 20 min after shot, began feeling faint, heart racing, nauseated, chilled. BP checked and 140-150 over 90-113. Pulse 130 range. Saw doctor propranolol given. Advised not to have another flu shot.				Y					Y	10/28/2005	10/28/2005	0		PUB	PVT	Premarin 0.32 mg;Pulmicort inhaler B.I.D.	NONE	Asthma			1						1	Dizziness; Feeling cold; Hypertension; Nausea; Palpitations	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA151BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0248365	11/29/2005	WA	43.0	42		F	11/18/2005	About 20 minutes after receiving vaccine, patient started to feel nauseous, slight dizzy and felt a headache coming on. Patient had to go to the bathroom and vomited twice. A staff nurse assisted her and walked her to her office where patient laid down and was covered by a blanket. An initial BP reading was 139/82. Patient laid in her office for about 20 minutes under observation but had to get up to vomit again. Patient sister in-law came to pick up patient to take her to her residence. BP taken just before leaving an hour after BP was 136/80.									Y	10/28/2005	10/28/2005	0		PUB	PVT	NONE	NONE	NONE			1						1	Dizziness; Headache; Nausea; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA151BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0248366	11/29/2005	CA				F		Patient received FluMist vaccine on 10/20/05 after 48 hours she felt weak, generalized, with vomiting and diarrhea.									Y	10/20/2005	10/22/2005	2	NONE	PVT	PVT		NONE	NONE			1						1	Asthenia; Diarrhoea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500387~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0248367	11/29/2005	NY	67.0	67		M		11/14/05 Got both shots in left arm at 10 am. 11/15/05 Left shoulder sore and inflamed, fever 100.5 degrees F, nausea. 11/16/05 Inflammation and swelling of left arm spreading down past elbow. 11/16/05 Went to ER at 5 pm. 11/16/05 9 pm treatment apply cold packs to reduce swelling and inflammation. Take Cephalexin 500mg, Zyrtec 10mg; Methyl prednisolone 4 mg as prescribed. 11/17/05 Follow up with PCP 11:15 am continue treatment as above. MD wasn't sure if condition was reaction to vaccine or bacterial infection of ski. Wrote prescriptions to treat both possibilities.				Y					U	11/14/2005	11/15/2005	1		PUB	OTH	Lipitor 10mg;Temazepam 30 mg;Mirtazapine 7.5mg; Co Spot Vitamin E 400IU	NONE	Prostate Cancer- Radical Prostatectomy 8/2002			1						1	Injection site inflammation; Myalgia; Nausea; Pyrexia; Swelling	FLU3~AVENTIS PASTEUR~U1747AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0746P~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0248368	11/29/2005	WI	0.99	0	1	F	11/18/2005	Child began with rash to back and belly - began looking blotchy - worsened by 2 pm 11/5 - ped Benadryl given - no improvement - to ER given steroid 6pm. 11/5 50% improvement next am - by 11/6 pm worsened again - reported as hives to entire body - given epinephrine and Zantac per ER (2nd time to ER). 11/7 3-4 pm improved 11/8 am clear/ fully recovered				Y					Y	11/03/2005	11/04/2005	1		PUB	PUB	NONE	NONE	NONE			1						1	Rash; Rash macular; Urticaria	FLU3~SANOFI PASTEUR~U1765BA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248370	11/29/2005	PA	59.0	58		F	11/20/2005	Starting in 3 hours after vaccines, severe left arm pain. Next day rash developed around 15 cm from the site of the injections. Now 2 days after vaccine arm pain is improving but large rash persists.									U	11/18/2005	11/18/2005	0		PVT	PVT	synthroid		hypothyroidism			1						1	Pain; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61501~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0746P~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248371	11/29/2005	NE	0.59	0	.6	M	11/18/2005	Fever > 104									U	11/17/2005	11/17/2005	0		PVT	PVT						1						1	Pyrexia	FLU3~SANOFI PASTEUR~U1867DA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248372	11/29/2005	CA	2.0	2	.3	F	11/18/2005	Pt received Prevnar #4 in right deltoid on 11/16. Returned today with cellulitis at same area.									U	11/16/2005	11/17/2005	1		PVT	PUB						1						1	Vaccination failure	FLU3~SANOFI PASTEUR~U1765GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~SMITHKLINE BEECHAM~019BA~1~IM~LA~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~A98340H~4~IM~RA~PNEUMO (PREVNAR)~1	USA		Influenza
0248373	11/29/2005	VT	6.0	6		M	11/21/2005	7 X 9 cm red/firm blotchy edges over left deltoid. No streaks, no central papule									Y	10/25/2005	10/26/2005	1		OTH	PUB	tylenol					1						1	Erythema; Rash macular	FLU3~SANOFI PASTEUR~U1809AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248374	11/29/2005	NC	8.0	8		M	11/16/2005	Hives started about 2 hours post flumist vaccine. Started on face and chest; also c/o itchy scalp. Also slight swelling around chin. No difficulty breathing noted.				Y					Y	11/15/2005	11/15/2005	0		PVT	PVT	zithromax	strep pharyngitis				1						1	Face oedema; Pruritus; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500387P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0248375	11/29/2005	NY	1.72	1	.7	F	11/18/2005	Hives developed 24 hours after administration				Y					U	11/17/2005	11/18/2005	1		PVT	OTH	amoxicillin	OM				1						1	Urticaria	FLU3~SANOFI PASTEUR~U1872AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248376	11/29/2005	IN	3.0	3		F	11/21/2005	C/o weakness. I felt dizzy for 1-2 days after flu shot. He din't act himself and was tired, staggered when walking. Lasted for 1-2 day.									Y	10/17/2005	10/17/2005	0		PVT	PUB						1						1	Asthenia; Dizziness; Gait disturbance; Myasthenic syndrome	FLU3~SANOFI PASTEUR~U1746AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248377	11/29/2005	VT	57.0	56		M	11/21/2005	Vaccine at state employee flu clinic. Called PHN at 4:30 pm reporting onset of rough throat and mild difficulty swallowing - denied rash, itching, hives. Subsequently seen at Hospital ER. Client reports he was given Benadryl and prednisone. Held for observation then releashed.				Y					Y	11/18/2005	11/18/2005	0		PUB	PUB	allegra, nasalide		Allergies: dust, pollen, cat dander			1						1	Dysphagia; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U1930AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248378	11/29/2005	OH	5.0	5		M	11/21/2005	Hives 1 and half hour after flu shot given. Taken to er - Given Benadryl and prelone. Hives gone 2-3 hours after meds given				Y					Y	11/11/2005	11/11/2005	0		PVT	PUB	xopenex, pulmicort	asthma - hospital f/u	asthma			1						1	Urticaria	FLU3~SANOFI PASTEUR~u1903AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248379	11/29/2005	NJ	55.0	54		M	11/29/2005	Stutering, hot flush feeling on face shortness of breath. Dry cough									U	11/17/2005	11/17/2005	0		UNK	UNK						1						1	Cough; Dysphemia; Dyspnoea; Hot flush	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0248380	11/29/2005	PA	10.0	9		M	11/18/2005	Large local reaction left deltoid 16cmx10cm redness, swelling, tenderness, and itching. Started almost 24 hours after injection.									Y	11/15/2005	11/16/2005	1		PVT	PVT	Flovent	S/P Mono; Stomatitis	Asthma; Recurrent sinusitis			1						1	Injection site erythema; Injection site reaction; Injection site swelling; Pruritus; Tenderness	FLU3~SANOFI PASTEUR~U1903AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248381	11/29/2005	FL	67.0	67		F	11/21/2005	Within 24 hours of vaccine, local tenderness, swelling, erythema, fever, palpitations, HA, dyspnea. Vital signs 24 hours after vaccine: temp 101.5 oral; pulse 134; BP 136/80; R 15; Pulse Ox 95. Patient given Benadryl and Toprol after CXR, EKG and CB work done. Significant improvement after 5 days.				Y					Y	11/02/2005	11/02/2005	0	CXR negative; EKG: sinus tachycardia; CDG, CMP negative	PVT	PVT		NONE	COPD; Lung cancer 1996; S/P lobectomy			1						1	Dyspnoea; Erythema; Headache; Palpitations; Pyrexia; Sinus tachycardia; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U1777AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0512P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0248382	11/29/2005	MN	35.0	34		F	11/21/2005	At time of shot, left deltoid pain with shooting pain into left hand. Persistent left deltoid pain with exacerbation on froward flexion and lifting to horizontal.				Y					U	10/26/2005	10/26/2005	0		PVT	PUB	Zyrtec;MUI;Ortho Tri-Cyclen	NONE	Allergic - Rhinitis;Asthma mild			1						1	Movement disorder; Pain	FLU3~SANOFI PASTEUR~U1882BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248383	11/29/2005	MA	1.11	1	.1	F	11/16/2005	Slight rash developed on upper thigh, increased up to buttocks and down the leg to knee. Rash began as very red and raised to lacy then became bruise-like. Onset at 2 days lasting up to 2 weeks. Continues with slightly lacy bruise like redness; not itchy. Afebrile not painful. No treatment given.									Y	10/26/2005	10/28/2005	2	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Contusion; Rash erythematous	FLU3~SANOFI PASTEUR~U1747AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248384	11/29/2005	OH	53.0	53		M	11/16/2005	Generalized pain in area of immunization. Has persisted for about 2 weeks. Has not decreased and is not helped by OTC pain medication.									U	11/05/2005	11/07/2005	2	NONE	MIL	MIL		NONE	NKDA			1						1	Pain	FLU3~SANOFI PASTEUR~U1911A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248385	11/29/2005	OH	76.0			M	11/04/2005	Client reported an unexplained fever (101.4) of 12 hour duration six days post vaccine. Consulted MD who advised reporting symptoms.									Y	10/26/2005	11/02/2005	7	NONE	PUB	PUB		NONE				1						1	Pyrexia	FLU3~SANOFI PASTEUR~U1823AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248386	11/29/2005	MO	23.0	23		F	11/14/2005	6 PM at home, felt weak, hot, dizzy, and aching. Left arm numbness. 1st time she had the flu shot. Recovered by 11/9/05.									Y	11/08/2005	11/08/2005	0	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Asthenia; Dizziness; Feeling hot; Hypoaesthesia; Pain	FLU3~SANOFI PASTEUR~U1870AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248387	11/29/2005	MN	0.54	0	.5	M	11/17/2005	Received below vaccines about 1600 on 11/15/05, was on day 9/10 of Amoxicillin for sinusitis. Symptoms had resolved. 12 hours later, developed hives, low grade temp, and 1 loose stool. (Diffuse erythematous plaques with central white papule - face, trunk, and extremities). Treated with Benadryl. No wheezing/hypotension. Hives lasted 72 hours.									Y	11/16/2005	11/17/2005	1	NONE	PVT	PVT			Mild hypospadius			1						1	Diarrhoea; Erythema; Pyrexia; Rash papular; Urticaria	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B033BA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1743MA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE552AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A94439B~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0248388	11/29/2005	NY		40		F	11/21/2005	Awoke next morning with hives on buttock; used Hydrocortisone cream, self prescribed. Following day, Friday, took Benadryl, on own, with relief, resolving by Saturday. On Sunday, hives were getting larger, still taking Benadryl. On Monday, developed hives on each hand. Denies other symptoms. Referred to MD to assess.										11/16/2005	11/17/2005	1	NONE	PUB	PUB	Prevacid; Motrin; Xanax	NONE	Allergies: Percocet, Sulfa, Cipro, Minicycline			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1762AA~UNK~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248389	11/29/2005	MA	32.0	31		F		Pain (3/10) in left neck and lower jaw at rest, increasing with movement, talking, or swallowing. Radiating locally to neck and mouth and tender to touch lasting 2 days. Onset of symptoms 48 hours after vaccine administration. Some tingling and paraesthesia for about 5 hours.				Y					Y	11/04/2005	11/06/2005	2	ER visit revealed non infection and not thyroiditis.	PUB	UNK		NONE	NONE			1						1	Neck pain; Odynophagia; Pain in jaw; Paraesthesia; Tenderness	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248391	11/29/2005	MN	21.0	21		F	11/11/2005	Severe wrist left pain starting day after flu shot, progressively worsening each day. F/U with ortho DR. Thought it was Fracture. Diagnosis Dequairvains F/Vaccine.				Y					Y	11/07/2005	11/08/2005	1	X-Ray of wrist 11/11/2005 was negative.	PVT	PVT	NONE	NONE	Allergic to Celesporins.			1						1	Pain; Tendonitis	FLU3~SANOFI PASTEUR~1802FA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248392	11/29/2005	WI	46.0	45		M	11/15/2005	11/14/2005 9pm chills, sweating, T 99.2, weak, 11/15/2005 1am weak, frequent Bowel movements by x 5, Abdominal cramps, headache, felt like fainting, tachycardic ? rate, felt short of breath. 911 called in ER headache, stomach pain, med given. Headache remains now.				Y					Y	11/14/2005	11/14/2005	0	Blood draws, chest X ray, MD would not file VAERS, stated unrelated to vaccine and 11/16/2005 returned to work per wife.	PUB	PVT	NONE					1						1	Abdominal pain; Abdominal pain upper; Chills; Diarrhoea; Dizziness; Dyspnoea; Headache; Hyperhidrosis; Hypotonic urinary bladder; Pyrexia; Tachycardia	FLU3~SANOFI PASTEUR~U1915AA~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248393	11/29/2005	NE	29.0	28		F	11/22/2005	Chills, fatigues, hives x 7 days. Treated self with Benadryl.									Y	11/12/2005	11/13/2005	1	NONE	PUB	UNK		NONE	Seasonal Allergies			1						1	Chills; Fatigue; Urticaria	FLU3~SANOFI PASTEUR~U1929AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248394	11/29/2005	OK	53.0	52		F		Broke out in hives hours after shot.									Y	11/17/2005	11/17/2005	0		UNK	UNK		NONE				1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0248395	11/29/2005	IL	44.0	43		M	11/21/2005	Aches.									Y	11/14/2005	11/15/2005	1		OTH	OTH	Pravachol	NONE	NONE			1						1	Pain	FLU3~SANOFI PASTEUR~U1854AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248396	11/29/2005	IA	35.0	34		F	11/23/2005	Hives, rapid heart, nausea.				Y					Y	11/17/2005	11/17/2005	0		OTH	PVT						1						1	Heart rate increased; Nausea; Urticaria	FLU3~SANOFI PASTEUR~U1744AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248397	11/29/2005	AR	13.0	12		M	11/17/2005	Received vaccine 11/14/2005. 11/16/2005 in office with 4 inch diameter erythema warm, very painful to touch, slight swelling, no fever. By pm increased pain in arm and increased swelling. Placed on Cephazolin. 11/17/2005 am pt had fever 101 continued pain, erythema more blotchy, swelling same. 11/18/2005 erythema migrated but decreased afebrile, less painful.				Y					N	11/14/2005	11/16/2005	2		PVT	PVT	Advair, Albuterol		Asthma			1						1	Erythema; Feeling hot; Oedema; Pain; Pyrexia; Rash macular	FLU3~SANOFI PASTEUR~U1803AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0691P~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0248398	11/29/2005	IL	58.0	57		F	11/22/2005	About 5:00pm itchy scratchy throat, tightness, red scratchy eyes, mucus collected in corner of eyes. Shivers (did not have thermometer), nausea could not eat dinner. Took Benadryl about 5:30, Tylenol 6:00, felt better about 8:00-8:30 pm.									Y	11/14/2005	11/14/2005	0		OTH	PUB						1						1	Anorexia; Chills; Eye discharge; Eye irritation; Nausea; Ocular hyperaemia; Pharyngolaryngeal pain; Pruritus; Throat tightness	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0248400	11/29/2005	NV	75.0	74		F	11/28/2005	Site of injection hot and sore. Chills and temperature until 11/27/2005. Shaking so bad that nearly fell out of bed. On 11/24 called pharmacist who recommended Tylenol and adorosen every 5 hours. If don't take medication started shaking shaking by 4 hour. Also felt weak and Saturday had to take Albuterol because started wheezing.									N	11/19/2005	11/24/2005	5		PUB	PVT	Allegra, albuterol, Ambien, anadrine, atenold, buetaride, Lipitor, Acinopril, Nitroglycerin, Ped 3350 Electrolyte, Prilosec, Propoxin, Vitron C, Dedotex, Cocachin, Vebotyroxin, Ranacor, Cholocon.		Pace maker, asthma	unable to walk for 3 weeks~Td Adsorbed (no brand name)~~22.00~In Patient		1						1	Asthenia; Chills; Injection site pain; Injection site warmth; Pyrexia; Tremor; Wheezing	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0248401	11/29/2005	RI	37.0	36		M	11/21/2005	Patient reported feeling warm, flush, light headed, weak, perspiring. BP 72/48 pulse 54, radial pulse thru a day second BP 68/42, color waxy. Administered Epinephrine BP 92/70 pulse 62. Called 911 for EMT. Administered EPI by 160/90 pulse 58. EMT transported to Hospital.				Y					Y	11/08/2005	11/08/2005	0		PUB	PVT						1						1	Asthenia; Dizziness; Feeling hot; Flushing; Heart rate irregular; Hyperhidrosis; Hypotension	FLU3~SANOFI PASTEUR~U1866AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248406	11/29/2005	NC	59.0	58		F	11/29/2005	5 minutes after vaccine. pt c/o feeling weak, headache, tightness in throat.				Y					U	11/28/2005	11/28/2005	0	CBC, EKG done	OTH	UNK			Diabetes Mellitus, Arthritis, Hypertension, Thyroid Can, Hiatal hernia.			1						1	Asthenia; Headache; Throat tightness	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0247945	11/30/2005	MD	48.0	48		M	11/21/2005	MEDI003867 is a non serious spontaneous case from a consumer involving hearing loss. The reporter causality is possible to FluMist Vaccine. An 48 year old male consumer reported that he experienced bilateral hearing loss, tinnitus and ear fullness 2 days after he received FluMist vaccine on Oct 15 05. he described the symptoms as more on the left ear than the right side. He was seen by an ear doctor who did a hearing test at the clinic. He was prescribed oral steroids which improved his symptoms. However, on day after taking the last dose, his symptoms started to worsen again. The patient has not yet recovered. He stated that he thinks his symptoms are possibly caused by the FluMist vaccine. Verbal consent to contact his physician was requested but he stated that he wants to contact his physician first and will call back with the physicians name and contact number.									N	10/15/2005	10/17/2005	2	Hearing test.	PUB	OTH					MEDI0003867	1						2	Deafness; Ear discomfort; Ear pain; Hypoacusis; Inflammation; Laboratory test abnormal; Nasal congestion; Tinnitus; Ear discomfort; Hypoacusis; Tinnitus	FLUN3~MEDIMMUNE VACCINES, INC.~TBD~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500387P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0248403	11/30/2005	FL	62.0	61		F	11/29/2005	Was vaccinated in the evening of 11/14/05 and had minor discomfort at injection site. The next morning the deltoid muscle was sore. Arm has gotten progressively sore to the point today she is able to lift her arm to nipple height. Has pain radiating down to fingers and up to left side of neck. States she was unable to enjoy her vacation because pain was severe. 11/24/05 was first time she reported symptoms. I have taken her off duty today and have prescribed OT.				Y					U	11/14/2005	11/15/2005	1	NONE	PVT	PVT	Mobic	NONE	Degenerative disc disease (Cervical).			1						1	Injection site pain; Joint range of motion decreased; Myalgia; Neck pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61320~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0248404	11/30/2005	TX	59.0	59		F	11/29/2005	Patient received shot 3 PM. Experienced chills and fever of 101 F at 6 PM. Took Tylenol and slept. In AM, no more fever, but aches continued throughout next day.									Y	11/12/2005	11/12/2005	0		OTH	PVT	Buspirone; Combipatch; Metoprolol	NONE	NONE			1						1	Chills; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1913AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248439	11/30/2005	GA				F	11/04/2005	This is a non serious spontaneous case from a consumer in the USA involving PASSED OUT. The reporter causality is not provided to FluMist. An office manager in a pediatrics practice reported that an adult female passed out, fell and hit her head on the floor, a few minutes after she and her children received FluMist vaccine on 10/21/05, Friday. After 10 seconds, the patient woke up and could not remember what happened. Her husband came and brought the patient to her doctor and for a CT scan of the head. The husband stated that the patient had not had anything to eat that day except for a can of diet soda. Information on patient's medical history is not available. The following Monday, 10/24/5, a physician from the pediatrics practice called to check on the patient. He was told by patient that the head CT scan had no findings and that she was feeling fine and went back to work. (OMIC).									Y	10/21/2005	10/21/2005	0		PVT	OTH	NONE				MEDI0003809	1						1	Injury; Loss of consciousness	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0248440	11/30/2005	WI	32.0	32		M	11/15/2005	A physician reported that a 32 year old male patient received FluMist vaccine from a military clinic on 10/28/05. On 10/31/05, he noted flea-bite like rashes on his ankles, pruritic and had a burning pain sensation. He was seen by a medic at the military facility, who initially thought it was scabies and treated the rash with Permethrin cream. Over the next ten days, the rash progressed up to his legs, groin, abdomen, chest, back, neck, head, and scalp. Edema of the forearms, legs, and hands were also noted. A skin biopsy was done on 11/10/05, the result of which is unknown. On 11/12/05, he was admitted to a hospital. He was treated with oral prednisone, Zyrtec, loratadine, and ranitidine. No improvement was noted. On 11/14/05, the patient was transferred to a hospital. Upon admission, diffuse erythematous rash was noted. The reporter's description was that the patient's whole body looked like it was sunburnt. Micropustules were noted on the knuckles of the hands, arms, and thighs. Labs done at this hospital on 11/14/05 included: CBC which was within normal except for white blood cell count which was elevated (24,000); urine analysis was within normal and Basic Metabolic Profile (BMP), also within normal limits. A skin biopsy was done on admission and which confirmed diagnosis of Acute Generalized Exanthematous Pustulosis. Vital signs were within normal. A Triamcinolone whole body wrap was started as part of the treatment. Currently the patient is taking oral cetirizine, loratadine, and diphenhydramine for the rash and morphine for the burning pain sensation. On 11/15/05, some improvement was noted one day after the whole body wrap was administered. The micropustules were noted to be desquamating and the edema was less. Per the reporter, the patient did not have any past medical history, no known drug or egg/egg product allergies and was not taking any medications prior to receipt of FluMist. The patient received FluMist vaccine during the 2005-2006 flu season. The reporter assessed the adverse events as possibly related to FluMist vaccine, but also considered the possibility of drug reaction to the earlier treatments received for the rash. The patient was not yet recovered and remains admitted to the hospital.					Y				U	10/28/2005	10/31/2005	3	Basic metabolic profile: within normal; Skin biopsy: unknown/acute generalized exanthematous pustulosis; Urine analysis: within normal; WBC: 24,000.	MIL	MIL	NONE				MEDI0003849	1						1	Oedema peripheral; Pain; Pruritus; Rash; Rash erythematous; Rash pustular; Skin burning sensation; White blood cell count increased	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0248441	11/30/2005	TX				F	11/16/2005	This is not a serious spontaneous case from a consumer in the USA involving right ear neurosensory drop. The reporter causality is not provided to FluMist. A consumer reported that an adult female patient received FluMist on 1/7/05, and immediately after experienced stuffiness, congestion, and headache. This progressed to right ear fullness which never went away. Progressively, her hearing worsened and stated that she hears sounds in her right ear like water dripping. She was treated with a few courses of antibiotics and steroids. She was evaluated by two different ENT specialists and an audiologist. On 3/23/05, sinoscopy showed some inflammation within the sinus itself. Tympanogram showed normal pressure on both ears. Audiogram showed neurosensory drop on the right side. An MRI performed on 3/29/05 showed no acute intracranial abnormality nor any evidence of mass effect or enhancing lesions in the gray or white matter. The patient has not yet recovered. The reporter causality is not provided. (OMIC).  A follow up report will be submitted in accordance w/ 21CFR600.80. 4/12/2007.									Y	01/07/2005	01/07/2005	0		MIL	MIL	NONE				MEDI0003855	1						1	Audiogram abnormal; Ear discomfort; Headache; Hearing impaired; Immediate post-injection reaction; Inflammation; Nasal congestion; Neurosensory hypoacusis; Nuclear magnetic resonance imaging normal; Respiratory tract congestion; Sinoscopy; Tinnitus; Tympanometry normal	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0248444	11/30/2005	VA	10.0	10		F	11/07/2005	Site where administered the Pneumovax, red, warm, very tender, swelling 9x11cm and fever. Started 24 hours after vaccine. Continued for 4-5 days. Pt ok after antibiotic and antihistamine treatment.									Y	11/04/2005	11/07/2005	3		PVT	PVT	Zyrtec; Singulair; Nasonex	NONE	Cefzil; Zithromax; Erythromycin; Bactrim allergies.			1						1	Injection site hypersensitivity; Injection site oedema; Injection site warmth; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~U1824AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0704P~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248445	11/30/2005	CT	40.0	40		F	11/28/2005	On 11/5/05, developed fever 103.5, swollen left arm, stiff neck for 2 days, severe body aches and headache for 1 day. Was unable to attend work on 11/7/05 because of pain, discomfort and stiffness.									Y	11/04/2005	11/05/2005	1	NONE	PUB	PVT		NONE	NONE	Same~Influenza (Seasonal) (no brand name)~~37.00~In Patient		1						1	Discomfort; Headache; Musculoskeletal stiffness; Pain; Pyrexia; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA153AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0248446	11/30/2005	CT	42.0	42		F	11/28/2005	Patient described hives located on back, face, chest and abdomen 18 hours after receiving vaccine. The site where received was warm, red and induration about 48 hours. Took Benadryl.									Y	11/08/2005	11/09/2005	1	NONE	OTH	PVT		NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site warmth; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA153AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0248447	11/30/2005	WI	51.0	50		F	11/09/2005	Approximately 5-6 hours after administration of vaccine, developed pronounced injected sclera (bilateral) with no itching. Also pronounced facial flush - by 10-12 hours later, noted moderate muscle aches, neck ache (occipital area) and photophobia - bed rest and PO Ibuprofen and no S/S next morning.									Y	11/08/2005	11/09/2005	1	NONE	PUB	PUB	Lipitor; HCTZ; Ibuprofen	NONE	High cholesterol		WI0516	1						1	Flushing; Injection site reaction; Myalgia; Neck pain; Photophobia	FLU3~SANOFI PASTEUR~U1838AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248448	11/30/2005	WI	66.0	66		F	11/10/2005	Had approximately 5 episodes of feeling like she could not breathe or swallow between 11:00 PM on 11/9/05 and 1:40 AM on 11/10/05. I still have neck tightness as of 3:00 PM 11/10/05. Advised to contact her physician.									Y	11/08/2005	11/09/2005	1		PUB	PUB	Gemfribroeil; Potassium; HCTZ; Triampthine; Lipitor; OTC Calcium and D; Aspirin; Multivitamin	NONE	Atrial fibrillation - ablation 6/05; Hypertension; High cholesterol		WI0515	1						1	Dysphagia; Dyspnoea; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U1904AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248449	11/30/2005	WI	61.0	60		M	11/08/2005	Felt achy about 2 hours after immunization. Noted fever about 5:30 PM. Temp 102. Developed chills, nausea, vomiting. To ER about 10 PM. Evaluated and treated with Tylenol. Better by 1 AM; fine by 5 AM.				Y					Y	11/07/2005	11/07/2005	0	CXR; CBC; Urine	PUB	PUB	Humulin Insulin	NONE	Insulin dependent DM.		WI0514	1						1	Chills; Nausea; Pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1817AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248450	11/30/2005	WI	71.0	70		F	10/31/2005	10-12 pimples left deltoid around injection site. Itchy, painful. Scabbed over by 10/25/05.				Y					Y	10/20/2005	10/21/2005	1		PUB	PUB	Toprol		Hypertension		WI0513	1						1	Injection site vesicles; Pain; Pruritus	FLU3~SANOFI PASTEUR~U1744AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248451	11/30/2005	IL	43.0	42		F	11/22/2005	Difficulty taking a deep breath. Also had wheezing for approximately 2-3 hours. Overall body aches and burning eyes.									N	11/21/2005	11/21/2005	0		OTH	UNK		NONE	NONE			1						1	Dyspnoea; Eye irritation; Pain; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0248452	11/30/2005	PA	4.0	4		F	11/16/2005	Large area (5cmx7cm) of redness, blistery pimples overlying tender indurated soft tissue swelling at site of injection. Note: same thing happened last year, but milder.									Y	11/12/2005	11/13/2005	1	NONE	PVT	UNK		NONE	Hypotonic; Developmental delay; Seizure disorder			1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site vesicles	FLU3~SANOFI PASTEUR~U1854AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248453	11/30/2005	VA	51.0	51		F	11/28/2005	Severe headache with onset approximately 12 hours after vaccine receipt.				Y					Y	11/07/2005	11/07/2005	0	Ct scan of head normal; LP completed - results reported by patient as normal; CBC: WBC 6.5; RBC 4.01; Hgb 12.6; Hct 36.7; Platelet count 277; Prothrombin time 10.7; INR 1.04; PTT 33; Chem panel: Na 142; K 4.3; Chloride 104; CO2 27; BUN 10; Cr 0.9; Glu 101; Ca 9.6; Total Protein 7.5; Albumin 4.1; Bili total 0.1; AST 23; ALT 27; Alk Phos 76.	MIL	MIL	Neurontin; Ultram; Elavil on daily basis: PRN use of Vicodin; Zyrtec or Claritin	NONE	Chronic neck pain; Multiple allergies; Chronic tinnitus			1						1	Headache	FLU3~SANOFI PASTEUR~U1833BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248462	11/30/2005	OH	49.0	49		F	11/30/2005	Respiratory problems after flu shot.  Coughing, pain deep in lungs, red eyes overall aching/pain. Coughing lasted for several hours until I took Benadryl.  Flu like symptoms lasted for 2 days.									Y	11/18/2005	11/18/2005	0		UNK	UNK		No	None			1						1	Chest pain; Cough; Influenza like illness; Ocular hyperaemia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0248466	11/30/2005	CT	46.0	46		M	11/30/2005	Received flu shot on 11/17/05 at 10:20am. At 3:30 that afternoon bad coughing, fever (101), joints aching, dull eyes.									Y	11/17/2005	11/17/2005	0		UNK	UNK		NO				1						1	Arthralgia; Cough; Pyrexia; Staring	FLU3~SANOFI PASTEUR~U1945AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248468	11/30/2005	MA	49.0	48		F	11/30/2005	Received vaccine approx. 6:15pm Started with symptoms at 9:15pm. Had difficulty breathing, wheezing and coughing spasms. fine red rash noted on her neck and side of face. She went to hospital by 10:20pm where she received epinephrine injection and IV Benadryl. She remained under observation until 5am.				Y					Y	11/29/2005	11/29/2005	0		UNK	UNK	Zyrtec 10mg daily Alesse 28 daily (birth control)	none	allergic to Sulfa; mold; cotton tree; cockroaches			1						1	Cough; Dyspnoea; Rash; Wheezing	FLU3~SANOFI PASTEUR~U1854AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248469	11/30/2005	NC	44.0	44		M	11/30/2005	Onset of symptoms began morning of 11/17/05.  Diagnosis of Guillain-Barre Syndrome confirmed 11/18/05. Discharge summary states dizzy, hypertension,dysphagia, pain, apnea. Medical record states headache, paresthesia, weakness.			Y	Y	Y	11			U	11/08/2005	11/17/2005	9	Blood work, CT scan, Lumbar tap, MRI, Chest X-Ray, Nerve conductive study	UNK	UNK	none	none	none Medical records state GI disorder, hypertriglycemia, hypertension.			1						1	Apnoea; Asthenia; Dizziness; Dysphagia; Guillain-Barre syndrome; Headache; Hypertension; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~u1810aa~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0248470	11/30/2005	WA	43.0	42		M	11/30/2005	Pain slowly developed over 2-1/2 days. Awoke with severe pain in shoulder; resulted in emergency room visit @ 1:00am, 11/20/2005.  Treated for local allergic reaction, consisted of Prednisone (anti-inflamitory)for 5 days (20mg/day) and Percocets (pain killer) as needed.  Patient Comment: Believe shot was delivered too high into shoulder area of arm (near crest of shoulder).				Y					Y	11/17/2005	11/20/2005	3		UNK	UNK	None	No illnesses.	None			1						1	Pain; Shoulder pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0248471	11/30/2005	CO	49.0	49		F	11/30/2005	Onset of paresthesias of hands approximately one month after vaccination.  Slow progression of symptoms to include paresthesias of lower extremities followed by weakness. Diagnosis of Guillian Barre Syndrome made on Jan. 14, 2004.  1/10/06 Received hospital medical records of 1/14-1/15/2005. FINAL DX: Guillain Barre syndrome Records reveal patient experienced numbness & tingling in her extremities, decreased endurance, myalgias for several mo.  Saw PCP 12/08.  Continued to worsen & again saw PCP on 1/13 who did LP.  Admitted for IVIG.  Exam revealed decreased reflexes, sensation decrease in stocking-glove pattern, gait disturbance.   Per 60 day follow up report-Still with paresthesias of feet. Not yet working full time due to fatigue. Still with pareythemus of feet; weakness; fatigue but I continue to see improvement monthly.				Y	Y	1			N	10/07/2004	11/09/2004	33	Lumbar Puncture done on Jan. 14, 2005  All MRIs of head and neck were normal  Medical record states abnormal CSF: csf protein 239(H). MRI spine c/w DDD.	UNK	UNK	Dilantin Lexapro	no	Seizure disorder History of asthma (resolved) Allergic to latex and pecans  PMH: chronic back pain, kyphosis, reduction mammoplasty			1						1	CSF test abnormal; Guillain-Barre syndrome	FLU3~SANOFI PASTEUR~U1489AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0248472	11/30/2005	IL	85.0	85		M	11/30/2005	Seen 18nov05-swollen left arm/ hand.  Seen 21nov05- 3+ pitting edema progressed to MCP joints. Treatments---rx for Prednisones 18nov05--pt took 1 dose; got shakes & stopped taking it.  21nov05-- rx for Zyrtec; patient instructed to follow up x 1 week.				Y					U	11/16/2005	11/18/2005	2	none	MIL	MIL	Synthyroid; Nystatin; Aspirin; Proventil inhaler, Amiodarone HCL; Zocor; Alendronate sodium; Keflex; Colase;	none	Allergy to Sulfa drugs; Medical history of hypothyroidism; Atrial fib (cardiac disorders); osteoporosis; hx of nephrectomy;			1						1	Oedema	FLU3~SANOFI PASTEUR~U1858AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0055R~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0248473	11/30/2005	NC	31.0	30		F	11/30/2005	Swelling, redness, warmth and pain at injection. Developed cellulitis.				Y					Y	10/27/2005	10/29/2005	2		UNK	UNK	Norvasc, Metformin, multivitamin	Hypertension, hirsutism, pregnancy, mild hypertriglyceridemia	Benadryl (h/o porphyria in family)			1						1	Cellulitis; Injection site erythema; Injection site pain; Injection site reaction; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0751P~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0248474	11/30/2005	NC	20.0	19		F	11/30/2005	Swelling, redness, warmth and pain at injection site.  No treatment required.									Y	10/17/2005	10/18/2005	1		UNK	UNK	pernatal multivitamin, acetaminophen	h/o 2 miscarriages, 24 wks pregnant	none			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0751P~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248475	11/30/2005	MA	54.0			M	11/30/2005	Several years ago developed wrist pain 3-4 days after flu vaccine.  Had a couple of years w/ no reaction.  Last year developed wrist, ankle, elbow pains w/o fever, malaise or other flu like symptoms, aches persisted for 2-4 days.  This year again had no constitutional symptoms except aches in wrist (particularly L), elbows and ankles, and aches lasted longer then 2-4 days but were treated well w/ anti inflam meds.  vaccinated as part of employee health program at the hospital.									Y				None	UNK	UNK	none	none	none			1						1	Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~U1825BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0248478	11/30/2005	WI		0	.8	F	11/30/2005	Patient's mother reported 2 seizures lasting 30 minutes, generalized. 12/22/05 Review of d/c summary. Diagnosis confirmed as seizure. Episodes of staring and perioral cyanosis were noted. No fever.					Y	2			Y	11/16/2005	11/17/2005	1	Normal EEG, Normal MRI 12/22/05 Per review of d/c summary - CT of head was normal.	PVT	UNK	NONE					1						1	Convulsion; Cyanosis; Staring	FLU3~SANOFI PASTEUR~U1787EA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A85856P~3~~RL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0248482	11/30/2005	MA	1.03	1	.0	F	11/30/2005	Bloching rash chest/abd/leg duration , area 0.5- 1 cm									U	11/17/2005	11/21/2005	4		PVT	UNK						1						1	Rash	FLU3~SANOFI PASTEUR~10765FA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~10728~UNK~~LA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA		Influenza
0248483	11/30/2005	SC	46.0	46		F	11/30/2005	Shot in left arm. Glands on left side of body badly swollen. (at base of neck, groin of left leg)									Y	11/16/2005	11/17/2005	1		PUB	PVT	Allegra, flovent		Asthma			1						1	Oedema; Pharyngeal oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0248484	11/30/2005	WV	82.0	81		F	11/30/2005	Developed petechiae and purpura of legs bilaterally several days after the injection. Skin changes lasted around 2 weeks.									Y	11/08/2005	11/13/2005	5	CBC normal 11/21/05	PVT	PVT	zoloft, HCTZ, Diovan, lovad, fosain, zanax		CAD, HTN,  high lipids, osteoporosis, kidney stone, pcn allergy			1						1	Petechiae; Purpura	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61998~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0248486	11/30/2005	WI	23.0	22		F	11/30/2005	Itching white hives on back, abdomen and legs. 19 days post Inactivated Influenza virus Fluzones. No SOB									Y	11/10/2005	11/29/2005	19	Hx allergies; drugs, codeine, cats	OTH	OTH	Birth control unknown name					1						1	Hypersensitivity; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1764AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248490	12/01/2005	CA	45.0	44		F		Initial report received from a health care professional on Nov 21 2005. A 44 year old female received an injection of Fluzone SV 2005-2006 USP on Nov 4 2005. Eight days later the patient gradually developed weakness of her lower extremities. The weakness progressed to where the patient was unable to walk, She was hospitalized and diagnosed with Guillain Barre syndrome. No information was provided regarding the patients treatment. At the time of this report, the patient was improving, but was in rehabilitation. She has not recovered from the events.					Y	7			N	11/04/2005	11/12/2005	8		PUB	PUB			The patient has a history of allergy to sulfa.		200502537	1						1	Abasia; Asthenia; Guillain-Barre syndrome; Hypokinesia	FLU3~SANOFI PASTEUR~U1848AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0248492	12/01/2005	LA	59.0	58		F	11/29/2005	I was vaccinated about noon on Saturday, November 12 2005. By bedtime that night, my upper arm shot area was starting to get red. Sunday, my arm was itching and I started getting chills. Sunday night my arm was swollen and red shot area upper arm. Monday I had the nurse at the health unit check it. She advised me to go to my doctor. My doctor was out of town so his nurse looked at it. She said I needed to be seen by a doctor that day. I went to the clinic. The doctor there and both nurses above said I had cellulitis, The doctor prescribed oral antibiotics twice a day for ten days.			Y	Y					Y	11/12/2005	11/12/2005	0		OTH	OTH	Atenolol; Detrol LA; Dapsone; Lipitor; Hydrochlorothiazide; Estradiol; Levothroid; Quinapril		Dermatitis herpetiformis; Allergic to wheat, rye, barley, and oats in all forms and shapes.	Allergic reaction; caught flu; relapsed flu~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Cellulitis; Chills; Injection site hypersensitivity; Injection site oedema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0248494	12/01/2005	NH	30.0			F	11/13/2005	45 minutes after receiving flu shot developed severe shortness of breath and chest pain. Troponin I, note: pt is not allergic to eggs. Additional terms from Dis Dummary rec'd on 12/02/2005: Tachycardia, Resp. Distress, Wheeze, React Aggrav, Lab Test Abnormal/sr			Y		Y				Y	11/11/2005	11/11/2005	0	Troponin I 0.41 11/12/2005; Small Q waves on EKG; O2 sat initially 93% on 100% NRB.	UNK	UNK			Asthma			1						1	Chest pain; Condition aggravated; Dyspnoea; Laboratory test abnormal; Respiratory distress; Tachycardia; Wheezing	FLU3~SANOFI PASTEUR~U1823AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0248495	12/01/2005	OH	26.0	26		M		Complaints of fever, never took temp but felt hot with generalized malaise, aches in legs for 3-4 days and then tremors to legs. Lasted approximately 7 weeks. Seen by private physician and was taken off current meds - Wellbutrin, Claritin, Nasarel at about day 4. Placed on steroids at that time. Was told by his physician that it was due to the egg protein in the vaccine. (OMIC). Serum Sickness No new terms added from Medical Record rec'd 12/12/2005.									Y	11/01/2005				UNK	UNK	Wellbutrin; Claritin; Nasarel					1						1	Malaise; Pain; Pyrexia; Serum sickness; Tremor	FLU3~SANOFI PASTEUR~U1854AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248496	12/01/2005	OH	46.0	46		F		Day after vaccine, complained of aching bilateral legs and sore ankles. Ankles red and hot with pain. Still present and improves with ambulation. Denies tremors, nausea, vomiting, diarrhea or fever. (OMIC)									Y	10/20/2005	10/21/2005	1		UNK	UNK	Vitamins and Iron					1						1	Erythema; Feeling hot; Pain	FLU3~SANOFI PASTEUR~U1804AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248497	12/01/2005	FL	60.0	59		M	11/30/2005	Pt c/o trouble swallowing 45 min after receiving flu shot. No other c/o. No local reaction. VSS, gave 2 children's benadryl fast use and take VSS 20 min later. Pt refused further Tx. Instructions given to call 911 if symptoms worsen. Pt stable 1.5 hours after flu injection given.									Y	11/16/2005	11/16/2005	0		UNK	UNK			Allergies: Peanuts, glycerin			1						1	Dysphagia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0248498	12/01/2005	CA	5.0	5		M	11/30/2005	5 year old male seen 11/19/05 for well child exam. Exam included DTaP and Influenza vax in right upper outer arm. Plus left arm IPV, MMR, Pneumoccol 23 vax. 11/21/05 seen for redness and blistering right arm 11/22/05. 5 x 3 cm area of blistering 10 x 10 area of heat, redness and swelling.									U	11/19/2005	11/21/2005	2		UNK	UNK			severe development delay, blind, seizures, microcephaly			1						1	Blister; Erythema; Skin warm; Swelling	DTAP~UNKNOWN MANUFACTURER~~UNK~~RA~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~~LA~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~~LA~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0248499	12/01/2005	AL	40.0	40		F	11/25/2005	Flu vaccine gotten 10/05/05 pt c/o arm hurting off and on since injection. No visible problem at all, just hurts. She first called health dept. 11/21/05 to report continues to hurt off and on. Aleve and Ibuprofen not helped.									Y	10/05/2005	10/05/2005	0		PUB	PUB					AL0518	1						1	Pain	FLU3~SANOFI PASTEUR~U1761AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248500	12/01/2005	AL	69.0	69		F	11/21/2005	Pneumonia administered with flu imm on 11/18/05 - That evening pt states arm - lower 2/3 of upper arm (above elbow) started to swell and was painful. Pt states used treat on it Fri pm only. By Sunday swelling and soreness began to subside. As edema subcided orange discolorization began to appear. Today arm not sore but has orange skin color in lower 2/3 of upper arm. Pt reports no sob resp problems. High temp as any general reaction.									Y	11/18/2005	11/18/2005	0		PUB	UNK					AL0517	1						1	Body temperature increased; Oedema; Pain; Skin discolouration	FLUX~SANOFI PASTEUR~U1881AA~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0887P~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248501	12/01/2005	MI	63.0	63		M	11/14/2005	Swelling and discomfort of right foot progressfully worse next 2 days. Saw Podiatrist on 11/07. Diagnosed as either gout or arthritis. Antiinflamatories perscribed.				Y					N	11/03/2005	11/04/2005	1	x-rays, pedal pulse, comparisons blood work	PUB	PUB					MI2005037	1						1	Arthritis; Discomfort; Gout; Swelling	FLU3~SANOFI PASTEUR~U1904AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248502	12/01/2005	MI	78.0	78		M	11/15/2005	Client into County Dept of Public Health today. Reports raised red papules (pimples), that began as red blothces on interior, posterior torso, spreading to arms and legs. Very pruritic; papules had no discharge. Denies dyspnea, heart  (can't read) rash. Saw a few different doctors. Lesions began resolving 10/28/05.				Y					U	10/20/2005	10/24/2005	4	3 mm punch biopsy	PUB	PUB	oral hyperglycemic, hypertension medication, plavix, cholesterol		hpertension, diabetes, hypercholesterol		MI2005036	1						1	Rash macular; Rash papular	FLU3~SANOFI PASTEUR~U747AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248503	12/01/2005	NE	40.0	40		F	11/27/2005	Reported tingling, shooting pain in left deltoid with injection that has continued with movement or use of arm. Denied any redness or swelling. Heat helps, taking Ibuprofen tabs. Doesn't like doctors and refuses to see doctor when recommended.									U	10/26/2005	10/26/2005	0		UNK	UNK	glucosamine, zoloft, extragen, detrol, synthroid		Nerve damage to facial nerve caused by Pitritary tumor surgery			1						1	Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U1744AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248504	12/01/2005	AR	54.0	53		F	11/16/2005	11/15 throat was closing. Entire body covered with a violent red rash. 11/15 went to er x 2 and Dr. office x 7 hours. 11/16 back to Dr office. Later: found out pt ate coconut macroons with nuts. 15 minutes after symptoms started				Y					Y	11/04/2005	11/15/2005	11		PUB	PVT						1						1	Hypersensitivity; Rash erythematous; Throat tightness	FLU3~SANOFI PASTEUR~A120AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248505	12/01/2005	AR	33.0	33		F	11/21/2005	15 min post shot c/o slight sob and tingling. H/O asthma - appears complaint but no albuterol this am. Albuterol 2 puffs. 15 min later tightness resolving and tingling decreases. Has had chest congestion x 1 week - has received doxycycline x 7 days with 5 days remaining. Wears perfume with no usual problem. Has allergy appt later this month. 30 min post injection itching continues but no rash or sob. Denies egg allergy. First flu shot. Refused benadryl/mi 1 hr 15 min later no change. No hives. Advised to notify SVHC if further change									U	11/21/2005	11/21/2005	0		PUB	PVT		1 week chest congestion medicated	asthma, chest congestion, hypertension			1						1	Asthma; Chest discomfort; Dyspnoea; Paraesthesia; Pruritus; Pulmonary congestion	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61319~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0248517	12/01/2005	TN	52.0	51		F	12/01/2005	Vaccine given 11/16 at 9:15am. By 1pm, patient had cough and would eat ice.  3 hours later, patient's eyes burning, red and puffy.  Nasal airway swollen - no air; back of tongue swollen.  Patient has no known allergies. She took Benadryl 25mg three times that day and went to sleep.  The next day patient okay.									Y	11/16/2005	11/16/2005	0		UNK	UNK			no known allergies			1						1	Cough; Eye irritation; Eye swelling; Ocular hyperaemia; Rhinitis; Tongue oedema	FLU3~SANOFI PASTEUR~U1870AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248518	12/01/2005	OH	82.0	81		F	12/01/2005	48 hrs following influenza vaccination left deltoid developed erythema, edema and she noted all over muscle & joint pain and chills/night sweats. Sought her PCP's attention and was placed on a steroid dose pack and instructed to take anti-inflamatory of her choice (per phone conversation with nurse). As of today she is feeling much better, steroid tx is completed and she has no interest in taking another influenza vaccination in the future.				Y					Y	11/08/2005	11/10/2005	2	Serum Sickness per PCP.	UNK	UNK		NONE PER PATIENT	ALLERGIC TO MOTRIN, ERYTHROMYCIN & PCN  MED HX-IRON DEFICIENCY ANEMIA & ARTHITIS			1						1	Chills; Erythema; Myalgia; Night sweats; Oedema; Serum sickness	FLU3~SANOFI PASTEUR~U1793AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248520	12/01/2005	PA	63.0	63		F	12/01/2005	encephalitis/short term memory difficulty multiple lesions on mri treated with iv steroids 12/2/05 Per review of medical records the following additional symptoms were noted: distorted vision, confusion, loss of balance, falls, unusual smells, roaring in ears, increased urinary frequency, and weakness L leg. 12/22/05 Review of medical record indicates stroke in occipital lobe and ataxia.  Follow-up: 12/02/2005 - VERBAL REPORT FROM REPORTER: Date of admission was 11/22/05. Pt. likely to be discharged today or tomorrow. Final diagnosis is ADEM s/p influenza vaccine. Additional symptoms not mentioned on original VAERS report include left-sided weakness, gait disturbance. While in hospital the patient has exhibited intermittent sundowning. 12-2-05 Verbal report from vaccine provider: Lot # not recorded. Syncope and dizziness do not appear to be pre-existing to receipt of flu vaccine. Apparently patient had not had any previous flu vaccines.			Y	Y	Y	12	Y	Y	N	10/06/2005	10/17/2005	11		UNK	UNK	ZOCOR; ZIAC - S		syncope hypertension hyperlipidemia dizziness 12/2/05 - Reviewed medical records. Add mild occipital HA for many months and severe oral ulcers. 12/22/05 Per review of medical record add  allergy to PCN and morbid obesity.			1						1	Acute disseminated encephalomyelitis; Balance disorder; Cerebrovascular accident; Confusional state; Coordination abnormal; Delirium; Encephalitis; Fall; Gait disturbance; Hemiparesis; Memory impairment; Metamorphopsia; Muscular weakness; Parosmia; Pollakiuria; Skin ulcer; Tinnitus	FLU3~SANOFI PASTEUR~~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0248522	12/01/2005	FL	79.0	79		M	12/01/2005	Headache, generalized body aches, hives and joint pain.									N	11/17/2005	11/19/2005	2		UNK	UNK	Digoxin, quinadine, atenalol and fosama.	none	NKA			1						1	Arthralgia; Headache; Pain; Urticaria	FLU3~SANOFI PASTEUR~U1904AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248524	12/01/2005	OH	11.0	10		M	12/01/2005	Flu vaccine given 11.18.2005; bell's palsy noted 11.28.2005. Terms added from Discharge summary rec'd 01/08/2006: Blurred vision, myopathy, facial asymmetry/sr				Y					Y	11/18/2005	11/28/2005	10	Blood sugar 100mg/dl-wnl hearing test wnl	UNK	UNK	rhinacort aqua nasal palgic albuterol prn	allergic rhinitis	asthma allergies			1						1	Facial palsy; Myopathy; Vision blurred	FLU3~SANOFI PASTEUR~u1850aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248525	12/01/2005	VT	5.0	5		F	12/01/2005	She had 4 injections, 2 in each arm.  Flu and MMR in her right arm and IPV and DTaP in her left.  Today 2 days after her immunizations, the site of her left arm became 50% more swollen than before, very hot red and itchy.  It has spread around the arm like an arm band.  She had a very bad headache the day after her immunization.									U	11/29/2005	11/30/2005	1		UNK	UNK		no				1						1	Headache; Injection site erythema; Injection site warmth; Pruritus; Swelling	DTAP~UNKNOWN MANUFACTURER~~UNK~~LA~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~~LA~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0248526	12/01/2005	WV	56.0	56		F	12/01/2005	--palpitation for nearly two hours after shot --blood shot eyes couple hours after shot --tightness in left shoulder --left arm inflamed, hot, w/ a knot in the center of an area about 1 in diameter--palpitation and blood shot eyes were short-lived, redness w/ heat, knot, and tightness in shoulder are still evident.									N	11/30/2005	11/30/2005	0		UNK	UNK	Diovan	None	None			1						1	Erythema; Injection site inflammation; Injection site mass; Injection site warmth; Ocular hyperaemia; Palpitations	FLU3~SANOFI PASTEUR~u1824aa~2~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248528	12/01/2005	MI	58.0	58		F	12/07/2005	Patient states 1 Hour after flu vaccine. She was not feeling well. She hurt redness and swelling at the left upper arm. She started Benadryl 11/20. Presented 11/21/2005 no symptoms of cellulitis.									Y	11/16/2005	11/16/2005	0	CBC, Sed rate all normal limits.	PVT	UNK						1						1	Erythema; Malaise; Oedema; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA154~1~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0248530	12/01/2005	MO	51.0	50		F	10/14/2005	Received vaccine Fluzone 10/13/2005 at 12pm. Symptoms started at 3:30pm. Reported nasal congestion, over production of sputum, conjunctivitis, Shortness of breath.									Y	10/13/2005	10/13/2005	0	NONE	PUB	PUB		NONE	EES, Neosporin, IVP Dye			1						1	Conjunctivitis; Dyspnoea; Nasal congestion; Productive cough	FLU3~SANOFI PASTEUR~U1775AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248531	12/01/2005	MO	53.0	53		M	10/14/2005	Heavy sweating, shortness of breath, chills, and very weak also light headed with headache, and upset stomach.									Y	10/11/2005	10/12/2005	1	NONE	PUB	PUB		NONE				1						1	Asthenia; Chills; Dizziness; Dyspnoea; Headache; Hyperhidrosis; Stomach discomfort	FLU3~SANOFI PASTEUR~U1775AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248532	12/01/2005	GA	1.48	1	.5	M	11/22/2005	Per daycare provider fever 103, got light blue around lips, increased motor activity then brief post ictal phase. ambulance called taken to ER where they were intercepted by parents who signed him out AMH and took him to another ER by private car. He was seen and diagnosed with febrile seizure and URI.				Y					U	11/17/2005	11/18/2005	1		PVT	PVT						1						1	Cyanosis; Febrile convulsion; Postictal state; Psychomotor hyperactivity; Pyrexia; Upper respiratory tract infection	DTAP~SANOFI PASTEUR~C2325AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1787GA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0688P~3~IM~RL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0239R~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0248363	12/02/2005	GA	56.0	55		F	11/25/2005	Oct 30 breathing problems, Tingling in fingers, toes, weakness in legs, lower back pain, total inability to move by Nov 2nd. Diagnosed as acute infective polyneuritis, treated with plasmapheresis, breathing improved. No in long term therapy. Arms, fingers still numb. Trouble walking still in therapy Nov 25.				Y	Y	25	Y		U	10/10/2005	10/30/2005	20	Spinal tap, High protein level.	PVT	PVT	Zocor		Hip joint degeneration, possibly from birth.			1						2	Anaemia; Asthenia; Bacterial infection; Bradycardia; CSF test abnormal; Fatigue; Guillain-Barre syndrome; Hypoaesthesia; Leukocytosis; Nausea; Urinary tract infection; Asthenia; Back pain; Difficulty in walking; Dyspnoea; Hypokinesia; Laboratory test abnormal; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U177AA~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0248538	12/02/2005	PA	1.07	1	.1	M	11/25/2005	Patient became ill within 24 hours of vaccine administration with URI symptoms, He was then discovered by parents to have stopped breathing.	Y	11/24/2005							N	11/22/2005	11/23/2005	1		UNK	PUB	NONE					1						1	Apnoea; Malaise; Upper respiratory tract infection; Abnormal sleep-related event; Coma; Lethargy; Pyrexia; Respiratory disorder	FLU3~SANOFI PASTEUR~U1787DA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1072P~1~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0418R~1~~~VARICELLA (VARIVAX)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~SANOFI PASTEUR~~UNK~~~HIB (ACTHIB)~2|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~2|VARCEL~MERCK & CO. INC.~~UNK~~~VARICELLA (VARIVAX)~2	USA	Results in Death	Influenza
0248539	12/02/2005		23.0	23		F		A report was received from a mother of a 23 year old female vaccine (Ref. NA05-010756). The vaccine has a history of fibromyalgia and is allergic to multiple antibiotics including, erythromycin, penicillin, clarithromycin, azithromycin, clindamycin, cefprozil, SMX/TMP, gatifloxacin and doxycycline. The vaccines concomitant medication include Triphasil for endometriosis and fluoxetine. The vaccine has received influenza vaccine in the past without event. On Nov 1 2005, the vaccine received Fluvirin (batch number 61350), intramuscularly. Within 2 hours of vaccination the vaccine experienced tremors of the hands and arms, low grade fever (99.2 to 100F) and myalgias. Fever and myalgias resolved with in 24 hours. Tremors progressed to seizures increasing in severity and frequency. The mother described seizures and jerking with posturing. The vaccine as admitted to hospital for seizure disorder workup. She was given an EEG and brain MRI which were both negative for any disorder. She was started on an anticonvulsant. She was discharged from hospital on Nov 14 2005 with diagnosis of pseudo seizures. The vaccinee continues to have tremors, she experiences 40-50 episodes a day. Follow up information will be sought.  Follow-up report received on 26 Nov 2009: The patient had a medical history of drug allergy to all antibiotics, fibromyalgia and had experienced car accident in 2004. This patient had another dose of FLUVIRIN on 03 Nov 2009. She experienced arm tremors two hours after injection and then experienced five hundred seizures in four weeks. The patient was hospitalized for six days at two different hospitals. The patient also developed confusion, exhaustion and a little memory loss on an unspecified date. The outcome of arm tremor, seizures, confusion and exhaustion was reported as fully recovered. Following internal review on 15 Apr 2010 of the data received on 25 Nov 2009, it was corrected to FLUVIRIN (batch number 61350). Follow-up report received on 29 Jun 2010 from consumer: Added ADACEL concomitant drug information. The patient's medical history included caesarean section, postural orthostatic tachycardia syndrome (Nov 2002), endometriosis, serum sickness, numerous surgeries due to strep bacteria settling in joints (1997-2001) and multiple drug allergies (penicillin, CEFZIL, propofol, BIAXIN, BACTRIM, ketamine, ZITHROMAX, CLEOCIN, BREVITAL, TEQUIN and doxycycline). It was reported that after car accident (occurred in 2004), the patient did not sustain a head injury, but suffered from cervical injuries as well as compression fractures of the spine between the lower thoracis and upper lumbar area. The patient was previously vaccinated with flu vaccines (Dec 2002 and Nov 2003) as well as meningitis vaccine (Jun 2000) and experienced unremarkable side effects. A chest CT was performed (date unspecified) and possibility of GUILLAIN-BARRE syndrome was ruled out. Electroencephalogram (EEG) showed some rhythmic slowing with abrupt return to base line suggesting a non epileptic origin. Head CT, brain MRI and blood work were normal. The patient's prolactin levels were 18.9 on 09 Nov 2005, 30.4 on 11 Nov 2005 and 37.2 on 12 Nov 2005 (suggesting true seizure activity as per neurologist). Urine analysis was negative for Wilson's disease and the patient was neurologically stable. The outcome of the events was not reported.					Y	6			Y	11/01/2005	11/01/2005	0	11/11/2005, Blood prolactin, 30.4, High; 11/12/2005, Blood prolactin, 37.2, High; 11/11/2005, Electroencephalogram, Showed some rhythmic slowing with abrupt return to base line suggesting a non epileptic origin	OTH	OTH	Triphasil;Fluoxetine; ATIVAN; Klonopin	Drug hypersensitivity; Fibromyalgia	The vaccinee has an underlying endometriosis and a history of fibromyalgia. Allergic to multiple antibiotics including, erythromycin, penicillin, clarithromycin, azithromycin, clindamycin, cefprozil, SMX/TMP, gatifloxacin and doxycycline. Has received influenza vaccine in the past without event. Road traffic accident; Caesarean section; Postural orthostatic tachycardia syndrome; Knee operation; Serum sickness		CVOX200500176	1						1	Amnesia; Blood prolactin increased; Blood test normal; Computerised tomogram head; Computerised tomogram normal; Confusional state; Conversion disorder; Convulsion; Convulsion; Dyskinesia; Dyskinesia; Electroencephalogram abnormal; Fatigue; Myalgia; No reaction on previous exposure to drug; Nuclear magnetic resonance imaging brain normal; Posturing; Pyrexia; Tremor; Tremor; Urine analysis normal	FLU3~EVANS VACCINES~61350~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~~UNK~UN~UN~TDAP (ADACEL)~1	USA	Hospitalisation	Influenza
0248540	12/02/2005		18.0			M	11/18/2005	A physician reported that an 18 year old male study participant experienced headache and diagnosed with viral meningitis 14 days after receipt of study vaccine on Oct 24 2005. He complained of headache on Nov 7 2005. On 11/08/2005, he went to the Emergency department where a spinal tap confirmed a diagnosis of viral meningitis. He was treated with unspecified medications and was discharged on Nov 11 2005. The patient recovered without sequelae. He went back to school on Nov 16 2005 and wad advised to follow up with his physician in a few weeks. No further information is available as the study participant refused to sign release of medical records. The investigator assessed the adverse events as possibly related to study vaccine.					Y	0			Y	10/24/2005	11/07/2005	14		OTH	OTH	NONE				MEDI0003874	1						1	Headache; Meningitis	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0248547	12/02/2005	MD	15.0	15		F	11/10/2005	11/08/2005 received flu shot and pneumo vaccine in left deltoid and PPD left forearm. Pain in left deltoid within 1/2 hour of recd shot. Swelling started by that evening and grew larger within 24 hours. Approx 4-5 inches from injection site dime size, non blanching erythema that was tender to palp started 24 hours later. By 48 hours erythema increased to about 4x3.									U	11/08/2005	11/08/2005	0	NONE	MIL	MIL	PPD, Enbrel, Synthroid, Cyotomel	None Acute, Chronic, Psoriasis, Hypothyroid (hashimotos)		high fever, uncontrollabel screaming 6 hours~DTP (no brand name)~1~17.00~Sibling		1						1	Injection site erythema; Injection site oedema; Injection site pain; Tenderness	FLUX~SANOFI PASTEUR~U1911AA~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0815P~1~IJ~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248548	12/02/2005	NY	43.0	43		F	11/28/2005	left deltoid with red, raised area approx 7 cm in diameter. Hot to touch and painful c/o shortness of breath more than usual. Pt is 1PPD smoker.				Y					U	11/25/2005	11/27/2005	2		OTH	OTH			PCN, Herniated disc			1						1	Dyspnoea; Feeling hot; Hypersensitivity; Injection site swelling; Pain	FLU3~SANOFI PASTEUR~U1826AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248549	12/02/2005	AZ	22.0	22		F		Received vaccine in am about 10am mother called me about 3pm patient had total body fine red rash some itching. Suggested Benadryl 5 mg PO and to see MD if not resolved.										11/22/2005	11/22/2005	0		OTH	OTH						1						1	Erythema; Pruritus; Rash	FLU3~SANOFI PASTEUR~U1816AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248550	12/02/2005	CA	67.0	67		F	11/22/2005	Hives, SOB, pressure in chest, spoke with her pharmacist told to go to the ER, went was treated and sent home after a few hours. Given a shot in ER and oral med for hives.				Y					Y	10/20/2005	10/20/2005	0	NONE	OTH	UNK		NONE	Hypertension, Gastritis on meds for these.			1						1	Chest discomfort; Dyspnoea; Urticaria	FLU3~SANOFI PASTEUR~U1828AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248551	12/02/2005	VA	1.11	1	.1	F	12/02/2005	Seen in ER on night of 11/28/2005 for high fever, had 3 short febrile seizures, labs drawn.				Y					Y	11/28/2005	11/28/2005	0		PVT	PUB		NONE	NONE Medical records state bronchitis, cough. msv			1						1	Febrile convulsion; Pyrexia	FLU3~SANOFI PASTEUR~U1765EA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248552	12/02/2005	OH				F	11/22/2005	Patient has never had a flu vaccine in the past. Patient received flu vaccine after denying allergies to anything, but Iodine. Stated, she has worn contacts and had no irritation to solution. Denies allergy to eggs or latex. Nurse administered flu vaccine 2-3 min later patient state I can't breath. My arms tingle. 1 pm B/P 168/110 P 170 R 30. Squad called. EPI administered per directions. 1:50 patient state I feel better. B/P 160/50 P 100 R 20. Alert, oriented. Squad arrived 2:00 pm transported to ER. 11-22-05 5 pm discharged from hospital with 2 more epi pins. 11/23/05 reported she had fully recovered to and went out Christmas shopping 11/23/05.									Y	11/22/2005	11/22/2005	0		PUB	UNK	UNK	NONE	Iodine			1						1	Blood pressure increased; Dyspnoea; Heart rate increased; Paraesthesia	FLU3~SANOFI PASTEUR~U1827AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248554	12/02/2005	CO	0.65	0	.6	M	10/14/2005	Marked edematous swelling of extremity developing over 48 hr. Non painful. Treatment Benadryl.									Y	10/10/2005	10/11/2005	1		PVT	PVT	NONE	NONE	Reactive airway disease			1						1	Oedema peripheral	FLU3~SANOFI PASTEUR~U1818AB~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248555	12/02/2005	NC	25.0	25		M		Off site flu clinic, school RN alerted us of reaction. Pt received shot and began to feel achy, feverish and have chills approx 1 hr after receiving shot. Approx 6:30 pm he told the RN his face swelled and felt like a lump in his throat. Also experienced watery eyes though out evening until Tuesday. He never saw an MD. His wife is a pharmacist and she gave him Claritin -symptoms began to resolve. 11/23/05 pt was feeling fine.				Y					Y	11/21/2005	11/21/2005	0		OTH	UNK			Allergy: Amoxicillin			1						1	Chills; Lacrimation increased; Pain; Pyrexia; Swelling face	FLU3~SANOFI PASTEUR~U1778AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248556	12/02/2005	IL	2.0	2	.5	F	11/23/2005	Pt received Varivax and Prevnar on 11/9/05. Mom noticed bumps a week later after staying at aunts. Aunt had a dog with fleas so attributed spot to flea bite. She noticed a scab (pt was itching) with bumps around it (not sure if fluid filled). Took her to ER and was told had infection related to vaccine site and started on Keflex to pt tid times 10 days. Mom brought her to office to be rechecked. Yellow scab with erythema and surrounding dry pustules on right upper thigh.				Y					Y	11/09/2005	11/16/2005	7		PVT	PUB	NONE	NONE	NONE			1						1	Erythema; Pruritus	FLU3~SANOFI PASTEUR~U1787EA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A98341A~4~~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1110P~1~~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0248557	12/02/2005	MI	74.0	73		F	11/28/2005	No adverse events until 10:30 pm next day. Got up from relaxing position suddenly felt dizzy, laid down on floor - proceeded to passed out momentarily - tried to get up and momentarily passed out again. Rested for approximately 3/4 hours and then was ok. No events since.									Y	11/08/2005	11/09/2005	1		MIL	UNK						1						1	Dizziness postural; Loss of consciousness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0248558	12/02/2005	IN	1.35	1	.3	M	11/28/2005	Pt received the vaccine on Wed 11/23/2005 at approximately 11am. Mom called clinic to report pt had awoken from nap at 3pm with large white welts on left leg, arm, and abdomen. No fever had slight cold with runny nose. Had received vaccine in left leg. Mom called physician who ordered Benadryl. No shortness of breath reported. Call mom today reported hives continued through Friday 11/25, used Benadryl with relief. Pt has had previous dose for vaccine 02/08 no apparent allergy to eggs.									Y	11/23/2005	11/23/2005	0		PUB	PUB		Cold, runny nose, slight fever				1						1	Pharyngitis; Rhinitis; Rhinorrhoea; Skin discolouration; Urticaria	FLU3~SANOFI PASTEUR~U1788EA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248559	12/02/2005	MI	27.0	27		F	11/28/2005	Returned approximately 90 minutes after getting injection stating her arm was itching. Arm where it was given is blotchy. No hives.									U	11/28/2005	11/28/2005	0		OTH	PVT						1						1	Pruritus; Rash macular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61128~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0248560	12/02/2005	TN	37.0	36		F	11/21/2005	Redness and swelling at site of influenza injection.									Y	11/18/2005	11/20/2005	2	NONE	UNK	UNK		NONE				1						1	Injection site hypersensitivity; Injection site oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA122BB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0248561	12/02/2005	MT	36.0	35		F	11/23/2005	Rash all over body and then progressed to hives (ears, neck, trunk, arms, legs).									Y	11/09/2005				PUB	PVT		NONE	NONE			1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~U1868AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248563	12/02/2005	OR	76.0	76		F	11/23/2005	Approx 4 Hours after receiving flu shot felt achy, which lasted thru the night. Face was red, on 11/18/2005 called Dr told to take Benadryl. She did so and redness went away. No redness on 11/19/2005. Did have facial redness on 11/20 and 11/21. Called Dr on 11/22. Told to take Benadryl. Do so and no redness since.									Y	11/17/2005	11/17/2005	0		PUB	PVT	Synthroid, Plaqunil, Atenolol, Sinemet, Vit C, Centrum, Calcium, Glucosamine with MSM.				OR200540	1						1	Erythema; Pain	FLU3~SANOFI PASTEUR~U1868AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248564	12/02/2005	OR	71.0	71		M	11/22/2005	Had flu shot about 10am 10/31/05. Approx 3pm experienced chills, fever, felt weak, decreased appetite. Reports no fever or chills next day 11/01/05 but continued to have low energy and low appetite. Episode lasted 2 1/2 days did not consult a doctor.									Y	10/31/2005	10/31/2005	0		PUB	PVT	Vitamins		Allergy to penicillin		OR200539	1						1	Asthenia; Chills; Decreased appetite; Pyrexia	FLU3~SANOFI PASTEUR~U1815AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0790P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248565	12/02/2005	OR	41.0	40		F	11/30/2005	Local erythema, edema, induration about 8cm in diameter at site. Within 24 hours of vaccine, she had a temp of 100.4, myalgias, pruritus, rash on upper chest, neck and upper back that is slightly raised, papular. 11/30/2005 no pruritus, erythema gone, mild induration.									Y	11/11/2005	11/12/2005	1		PVT	UNK	Lisinopril, HCTZ, Wellbutrin	NONE	Allergic reaction to Sporanox, rash urticaria, Hypertension.			1						1	Injection site erythema; Injection site induration; Injection site oedema; Myalgia; Pruritus; Pyrexia; Rash papular	FLU3~SANOFI PASTEUR~U1831AB~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0605R~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248567	12/02/2005	WA	49.0	49		M	11/29/2005	Very sore left arm since shot. It has not gone away. Pain wakes him up at night. Pain is located over left deltoid. It does not radiate. Is not associated with loss of function or numbness.				Y					N	10/27/2005	10/27/2005	0		PUB	UNK	on lipids		high cholesterol			1						1	Insomnia; Pain	FLU3~SANOFI PASTEUR~U1807AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248568	12/02/2005	NY	60.0	60		M	11/20/2005	Cellulitis infection on left arm. Emergency room visit and private doctor visit.				Y					U	10/27/2005	10/27/2005	0		OTH	UNK	cefadroxil					1						1	Cellulitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0248569	12/02/2005	NY	58.0	57		F		Cellulitis infection - swelling on arm. Visit to doctor.									U	10/27/2005	10/27/2005	0		UNK	UNK						1						1	Cellulitis; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248571	12/02/2005	OR	5.0	5		F	10/18/2005	A nurse practitioner reported that a 6 year old female experienced profuse bloody nose within 10 minutes of FluMist administration on Oct 17 2005. Bleeding resolved with ice pack and maintaining patient on a supine position. No other information was available at the time of the report. The reporter causality is not provided. A nurse practitioner reported that a 5-year-old female experienced profuse bloody nose within 10 minutes of receiving FLUMIST on 17Oct2005. The bleeding was resolved with ice pack and placing her in a supine position. On March 28, 2006 the nurse reported the event has completely resolved. Additional information date of birth and adverse event onset date/time and outcome.									Y	10/17/2005	10/17/2005	0	NONE	PVT	PVT					MEDI0003748	1						1	Epistaxis	FLUN3~MEDIMMUNE VACCINES, INC.~500391P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0248572	12/02/2005	LA	50.0	50		M	10/17/2005	A nurse reported that a 49 year old male received FluMist vaccine at an inappropriate site. At approximately 3:45pm on Oct 15 05, a nurse administered FluMist vaccine to the patient via intramuscular injection. The nurse reported that he was unfamiliar with FluMist and was unaware that it is approved for intra nasal use only. Not noticing the label that said for intra nasal use only, he broke off the tip of the FluMist syringe and aspirated the 0.5ml content using a different syringe with needle and injected it to the patient. As of Oct 24 2005, the patient did not report any adverse events but was advised to inform the nurse or call for emergency help if there need be. The reporter causality is not provided. Information received 06/23/2006. Lot # not available. Lost during act of nature.									Y	10/15/2005	10/15/2005	0		MIL	MIL					MEDI0003751	1						1	Medication error; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~1~~RA~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0248573	12/02/2005	IN	8.0	7		M	10/17/2005	MEDI-003745 is not a serious spontaneous case from a consumer or other non health professional involving elevated blood glucose (unlabelled). The reporter causality is not provided to FluMist. A medical assistant from a physician's office reported that a 7 year old male, with history of new onset juvenile diabetes, experienced elevated blood glucose levels ranging from 300-500 mg/dl, 2 days after receiving FluMist vaccine on 05Oct05. Per the reporter, the patient's mother has since brought the patient to his pediatric endocrinologist for management of the elevated blood glucose. The patient is also receiving insulin (dosage and frequency not specified). He has not recovered. The reporter causality is not provided.				Y					N	10/05/2005	10/07/2005	2		PVT	PVT	Concomitant Drug not reported	Juvenile diabetes			MEDI0003745	1						1	Blood glucose increased	FLUN3~MEDIMMUNE VACCINES, INC.~500289P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0248574	12/02/2005	CA	39.0	39		M		A nurse reported that an expired FluMist vaccine was administered to a 39 year old male patient on Oct 19 2005. There was no adverse event reported following vaccine administration, No other information is available. The reporter causality is not provided.									Y	10/19/2005	10/19/2005	0		PVT	OTH					MEDI0003752	1						1	Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~500101P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0248575	12/02/2005	TX	9.0	9		M	10/19/2005	A nurse reported that a 9 year old male experienced left nare closed. and multiple violent sneezing of about 15-20 times immediately after FluMist vaccine on 10/19/2005. There was no additional information at the time of report. The patients clinical outcome in unknown. Reporter causality is not provided. A nurse reported that a 9-year-old male experienced left rare clomire and multiple episodes of violent sneezing approximately 15-20 times immediately after receiving FLUMIST vaccine on 18Oct2005. The patient's clinical outcome is unknown. Reporter causility is not provided. 26Apr2006: Additional information received include date of birth, lot number and expiration date of vaccine.									U	10/18/2005	10/18/2005	0		OTH	OTH	Concomitant Drug(s) Not Used		Past disease: Leopard syndrome.		MEDI0003754	1						1	Immediate post-injection reaction; Nasal congestion; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~U1833BA~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0248576	12/02/2005	WI	38.0			F	10/20/2005	A nurse reported that an adult female received expired FluMist vaccine on an unspecified date. There were no adverse advents reported. No other information was available at the time of report. The reporter causality is not provided. Information received 06/23/2006. Adverse Event onset date/time, lot number of vaccine, and vaccine administration date/time are unavailable.									Y					OTH	OTH					MEDI0003759	1						1	Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0248577	12/02/2005	IL	7.0	7		F	10/25/2005	A 7 year old female had FluMist accidentally sprayed on her left eye on Oct 25 2005, when she moved her head back as a nurse was spraying the vaccine into her left nostril. As a result, the child experienced left eye photosensitivity. The affected eye was flushed with normal saline. On Oct 26 2005 the patients mother called the doctors office to inform them that the patient has fully recovered. The reported assessed the adverse event as possibly related to FluMist.									Y	10/25/2005	10/25/2005	0	NONE	PVT	OTH					MEDI0003769	1						1	Eye disorder; Medication error; Photosensitivity reaction	FLUN3~MEDIMMUNE VACCINES, INC.~500388P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0248578	12/02/2005	MD	3.0			M	10/25/2005	A physician reported that a 3 year old boy received FluMist vaccine by mistake on Oct 25 2005. No adverse event occurred at the time of report. The reporter causality is not provided.									Y	10/25/2005	10/25/2005	0		PVT	OTH					MEDI0003771	1						1	Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~500391P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0248579	12/02/2005	PA	3.0	3		F	10/26/2005	A physician reported that a 3 year old female received FLUMIST vaccine in error. No adverse event was reported to have occurred at the time of this report. The reporter causality is not provided.									Y	10/26/2005	10/26/2005	0		PVT	OTH					MEDI0003772	1						1	Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~500392P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0248580	12/02/2005	CO	45.0	45		F	10/27/2005	A nurse reported that an adult female received FluMist on Oct 26 2005 an accidentally sprayed the vaccine to her right eye. The patient flushed her right eye with liquigel and water. The patient also reported that she thinks her eyelashes caught most of the sprayed liquid. On Oct 27 2005, the reporter was informed by the patient that she is doing great and has completely recovered. The reporter causality is not provided. Additional information: date of birth, age at time of vaccination and lot number of vaccine.									Y	10/26/2005	10/26/2005	0		OTH	OTH					MEDI0003779	1						1	Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~500392P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0248581	12/02/2005	PA	40.0			F	10/28/2005	A nurse reported that a 40 year old female experienced FluMist vaccine accidentally sprayed on her eye when she received the vaccine on Oct 28 2005. No adverse event was reported. The reporter also stated that one third of the vaccine was administered on one nostril and the remaining two thirds to the other nostril, possibly due to been a problem with the divider dosing clip. No other information is available at the time of report. The patient completely recovered. The reporter causality is not provided.									Y	10/28/2005	10/28/2005	0		PVT	OTH					MEDI0003785	1						1	Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~500426P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0248582	12/02/2005	TX	6.0	6		U	10/31/2005	A nurse reported that a 6 year old child experienced nausea, vomiting and stomach pain. Three days after receiving FluMist on Oct 28 2005. the patient is being taken cared of at home. The patients clinical outcome is unknown. The reporter causality is not provided. No other information was available at the time of the report. Additional information has been requested. Follow up information - Patient DOB and vaccine lot number received.									Y	10/28/2005	10/31/2005	3		PVT	OTH	Concomitant Drug (s) Not Reported				MEDI0003792	1						1	Abdominal pain upper; Nausea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500386~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0248583	12/02/2005	GA	33.0	33		F	11/04/2005	MEDI-0003805 is not serious spontaneous case from a consumer involving sore throat. The reporter causality is not provided to FluMist. An office manager in a physician's office reported that a 33 year old female and 3 other office staff experienced headache and sore throat 2 days after receiving FluMist vaccine on 26Oct05. The patient recovered. The reporter causality is not provided. Follow up - Patient's  DOB received.									Y	10/26/2005	10/28/2005	2		PVT	OTH	Concomitant drug (s) not reported				MEDI0003805	1						1	Headache; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0248584	12/02/2005	GA	33.0	32		F	11/04/2005	MEDI-003806 is not a serious spontaneous case from a consumer in the USA  involving sore throat. The reporter causality is not provided to FLUMIST. An office manager in a physician's office reported that a 33 year old female and 3 other staff experienced headache and sore throat 2 days after receiving FLUMIST vaccine on 26Oct05. After taking Tylenol Ibuprofen, she completely recovered. The reporter causality is not provided.									Y	10/26/2005	10/28/2005	2		PVT	OTH	Concomitant drug not reported				MEDI0003806	1						1	Headache; Oropharyngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0248585	12/02/2005	GA	35.0	35		M	11/04/2005	MEDI-0003807 is a not serious spontaneous case from a consumer involving sore throat. The reporter causality is not provided to FluMist. An office manager in a physician's office reported that a 35 year old male and 3 other office staff experienced headache and sore throat 2 days after receiving FluMist vaccine on 26Oct05. This patient completely recovered. The reporter causality is not provided.									Y	10/26/2005	10/28/2005	2		PVT	OTH	Concomitant drug not reported				MEDI0003807	1						1	Headache; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0248586	12/02/2005	GA	36.0	36		F		MEDI-00068085 is not serious spontaneous case from a consumer involving sore throat. The reporter causality is not provided to FluMist. An 36 year old female office manager in a physician's office reported that she and 3 other office staff experienced headache and sore throat 2 days after receiving FluMist vaccine on 26Oct05. This patient recovered from the headache but sore throat continued. The reporter causality is not provided. A 36 year old female officer manager in a physician's office reported that she and 1 other staff experienced headache and sore throat 2 days after receiving FLUMIST vaccine on 26Oct05. SHe took TYLENOL and MOTRIN. She recovered from the headache but sore throat continued. The reporter causality is not provided. 12April2006: Additional information obtained: Patient's date of Birth.									N	10/26/2005	10/28/2005	2	NONE	PVT	OTH	Concomitant drug not reported				MEDI0003808	1						1	Headache; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0248587	12/02/2005	NJ	34.0			F	11/04/2005	MEDI-0003810 is a non serious spontaneous case from a consumer involving red pimple like dots around nose. The reporter causality is not provided to FluMist. A 34 year old female reported that she experienced red pimple like non-pruritic dots around the nose 2 weeks after receiving FluMist on 12Oct05. There was no medical intervention. The patient has not yet recovered. The patient's husband also experienced the same red pimple like dots a week after they both received the FluMist at their children's pediatrician's office. The reporter causality is not provided. This case is linked to MEDI-0003816.									U	10/12/2005	10/26/2005	14		PVT	PVT	Concomitant drugs not used				MEDI0003810	1						1	Acne; Erythema	FLUN3~MEDIMMUNE VACCINES, INC.~500386P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0248588	12/02/2005	NJ	38.0			M	11/08/2005	MEDI-0003816 is a non serious spontaneous case from a consumer involving red pimple like dots around the nose. The reporter causality is not proved to FluMist. A consumer reported that her 38 year old husband developed red pimple like, non-pruritic, dots around the nose one week after receipt of FluMist vaccine on 12Oct05 from his children's pediatrician's office. As of 08Nov05, the dots persisted, but are now less and brownish in color. The reporter causality is not provided. The reporter also reported that she experience the same adverse event two weeks after receiving FluMist vaccine. This case is linked to AER # MEDI-0003810.									N	10/12/2005	10/19/2005	7		PVT	PVT	Concomitant drugs not used				MEDI0003816	1						1	Acne; Erythema	FLUN3~MEDIMMUNE VACCINES, INC.~500386P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0248602	12/02/2005	OH	46.0	45		F	12/02/2005	PAIN AT SITE OF INJECTION IN THE SHOULDER WENT TO ER MD SAID MAY HAVE NICKED A NERVE AND IT WOULD PROBABLY BE SORE FOR A COUPLE OF WEEKS PATIENT SAID PAIN WAS IN THE ARM SHE GOT HER PNEUMONIA SHOT IN				Y					Y	10/31/2005	10/31/2005	0		UNK	UNK						1						1	Injection site pain	FLU3~SANOFI PASTEUR~U1833BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0248603	12/02/2005	DC	26.0	25		F	12/02/2005	7cm x 8cm localized erythema and pruritic reaction starting approx 8 hours after vaccine administration. No respiratory complaint. Treated with Loratidine 10mg once a day and Diphenhydramine 25mg every pm until symptoms resolve.									Y	11/30/2005	11/30/2005	0	None	UNK	UNK	Albuterol, Advair, Ortho Evra patch		Penicillin, Codeine Asthma			1						1	Erythema; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62017~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0248604	12/02/2005	IL	85.0	84		F	12/02/2005	11/25/05 Patient called and spoke with Branch Manager in re: to having a flu and pneumonia shot on 11/22 and is experiencing swelling in arm....(it was not documented which arm this was occuring in). Director has attempted several times to reach patient to get more information.....calls were not successful..phone not answered.									U	11/22/2005	11/23/2005	1		UNK	UNK	Unknown	Unknown	Unknown			1						1	Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62017~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1038p~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248606	12/02/2005	FL	34.0	34		F	12/02/2005	Flu shot yesterday - right after flu shot my toes started tingling, then the tingling increased - numbness started today.  I can't move my right arm or leg due to numbness.  no trouble breathing, having trouble urinating, onset of syptoms was about 5 minutes after the flu shot according to the patient. Medical records state asthenia, urinary incontinence; apathy. msv I tried to follow up with this pt today, the phone number on her records has been diconnected.				Y	Y				U	12/01/2005	12/01/2005	0	Medical record states Lab test abnormal. msv Per 60 day follow up report-no further information available.	UNK	UNK	Advair, Albuterol	no acute illness	Viral encephalitis, transverse myelitis, multiple sclerosis, Guillian-Barre Syndrome Medical records states palpitation, asthma. msv			1						1	Apathy; Asthenia; Hypoaesthesia; Laboratory test abnormal; Paraesthesia; Urinary incontinence	FLU3~SANOFI PASTEUR~U1802EA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0248609	12/02/2005	IA	32.0	32		F	12/02/2005	Patient developed nausea and vomiting earlier the day of 28 Nov 05.  ER visit on am of 29 Nov 05.  Patient given IV analgesics, antiemetics,a nd IV fluids; diagnosis of volume depletion and viral syndrome.  Patient discharged to home.  Lost consciousness at home and fell off bed.  Transported to ER and intubated by EMT.  Patient is currently an inpatient at hospital. Information from Medical records states cough,myocarditis, cardiovascular disease. Mechanical ventilation & ICU.  Tx w/IVIG.  Feeding tube.  Slow improvement & transferred to inpatient rehab. Discharge summary states Guillian-Barre syndrome, myocarditis, apnea, pneumonia.			Y	Y	Y	30			U	10/31/2005	11/28/2005	28	EMG indicative of Guillian-Barre syndrome.  Sputum normal, Ct of Brain normal; all other WNL; negative lumbar puncture; negative strep screen Medical records state abnormal lab tests.	UNK	UNK		none indicated	NKDA, hypertension			1						1	Apnoea; Cardiovascular disorder; Cough; Fall; Guillain-Barre syndrome; Hypoxia; Laboratory test abnormal; Loss of consciousness; Myocarditis; Nausea; Pneumonia; Viral infection; Vomiting	FLU3~SANOFI PASTEUR~U1794AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0248610	12/02/2005	GA	51.0	50		F	12/02/2005	Complained of muscle aches and fever requiring a visit to the ER.  This episode lasted less than 24 hours.  All tests and cultures were negative.  The physician told him that he felt the event was due to an allergic reaction to the flu vaccine.				Y					Y	11/20/2005	11/20/2005	0		UNK	UNK		None reported	Allergic to Stadol- steroids.  Had back surgery - goes to the pain clinic had gastric bypass surgery			1						1	Hypersensitivity; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1846AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248611	12/02/2005	UT	51.0	50		F	12/02/2005	CHIEF COMPLAINT: Allergic reaction.  HISTORY OF PRESENT ILLNESS: This 50-year-old female was in her usual state of health until about 30 minutes after getting her flu shot today. She then started to have itching in her palms which she recognized as an allergic reaction, having had a similar response to a soap which she is allergic to in the past. She then began to get flushed and itchy all over and began to notice some fullness in her lips and tongue and a sense of presyncope and pending doom. She was quickly placed in one of our patient care rooms where an IV access was established and I saw her. She had a hard time providing me much history initially because she was so anxious and uncomfortable. She did not report having problems breathing. She did not feel as though her airway was closing off.  PLAN: Received 50 mg of IV Benadryl and 8 mg of IV Zofran. Over the next 15 to 20 minutes her symptoms dramatically improved and she was observed for another hour. She received 1 L of IV fluid during that time and was essentially asymptomatic at the time of discharge except for a little bit of residual swelling in her hands. The patient will take 50 mg of Benadryl at bedtime tonight. She will continue the Benadryl on a q.6h. basis for the next 24 to 48 hours unless her symptoms have resolved in the morning and she is feeling well. She was told that if she was feeling up to it she could return to work tomorrow.				Y						11/16/2005	11/16/2005	0	CONTEMPORANEOUS EKG INTERPRETATION: A 12-lead EKG shows a normal sinus rhythm at 90 beats per minute. She does have a bit of a prolonged QT interval. She has some mild nonspecific inferolateral T-wave abnormality which I think is minimally changed from a previous tracing.  MEDICATIONS: Inderal, Depakote, Tegretol, trazodone, and a p.r.n. Imitrex. She had a shot of Imitrex this morning.	UNK	UNK	MEDICATIONS: Inderal, Depakote, Tegretol, trazodone, and a p.r.n. Imitrex. She had a shot of Imitrex this morning.	unknown	PAST MEDICAL HISTORY: She has a history of SVT. She is status post hysterectomy. She had some minimal valvular heart problems associated with Phen-Fen use several years ago.			1						1	Anxiety; Discomfort; Face oedema; Flushing; Hypersensitivity; Oedema peripheral; Pruritus; Tongue oedema	FLU3~SANOFI PASTEUR~U1816AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248613	12/02/2005	IL	69.0	69		F	12/02/2005	Patient came back to our branch on 11/30 to notify us that 3 hours after she recieved her pneumo shot that she had swelling/redness/hurting in her right arm.  This was the arm she received the pneumo shot in on 11/29.  I told her to elevate the arm,apply ice and if not better on 12/1 tp ca;; me after she notifies her physician.  On 12/1 she went to her physician and he gave a prescription for an antibiotic.				Y					U	11/29/2005	11/29/2005	0	Unknown	UNK	UNK	Unknown	Unknown	Unknown			1						1	Erythema; Pain; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62017~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1038p~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0248634	12/02/2005	UT	27.0	26		M	11/18/2005	C/O itching, burning and tightness of throat 10 minutes after flu shot. Given antihistamine, observed for 30 minutes with vital signs monitored- sent to MD.									Y	11/14/2005	11/14/2005	0	NONE	OTH	PVT	UNK	NONE	Knee surgery with pulmonary embolism post-op			1						1	Pruritus; Throat tightness	FLU3~SANOFI PASTEUR~U1848AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248635	12/02/2005	NJ	79.0	78		F	11/23/2005	Daughter states : My mother became nauseous after receiving the flu shot. She was also lethargic and her face appeared reddened around the cheeks. She felt like that until about 7 pm. She refused to go to an emergency room. Her MD was not available . She felt better after 7 pm.									Y	11/22/2005	11/22/2005	0		PUB	PUB		NONE	NONE		NJ200514	1						1	Erythema; Lethargy; Nausea	FLU3~SANOFI PASTEUR~U1916AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248636	12/02/2005	NJ	35.0	35		M	11/21/2005	Full body ached could hardly move, had a pounding headache for several days, skin hurt to the touch. Right arm was red and sore for several days, had chills and cold sweats. Body was flush.				Y					Y	11/07/2002	11/08/2005	1097		PUB	PUB		NONE	NONE		NJ200515	1						1	Chills; Erythema; Flushing; Headache; Hyperhidrosis; Hypokinesia; Myalgia; Pain; Tenderness	FLU3~SANOFI PASTEUR~U1904AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0513P~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0248637	12/02/2005	CA	1.92	1	.9	M	11/09/2005	Rash upper chest 24-48 hrs post vaccination.									N	11/02/2005	11/04/2005	2	NONE	PVT	PUB	Tri-Vi-Flor		NONE		CA050081	1						1	Rash	FLUX~SANOFI PASTEUR~41765AA~1~~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PNC~PFIZER\WYETH~B086343~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0248638	12/02/2005	CA	1.36	1	.4	M	12/02/2005	Local tissue induration and erythema at vaccine administration site.									U	11/30/2005	12/02/2005	2		PUB	UNK		NONE	NONE			1						1	Injection site erythema; Injection site induration	DTAP~SANOFI PASTEUR~C2277AA~UNK~~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1765AA~UNK~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~U2716AA~UNK~~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A56117E~UNK~~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0248639	12/02/2005	MI	56.0	55		F	12/02/2005	Flushed, shortness of breath, headache, disoriented.										11/28/2005	11/28/2005	0		OTH	PVT	Detrol LA;Lisinopril;Inderal La;Zocor;Ambien	NONE	Hypertension, Nickel			1						1	Disorientation; Dyspnoea; Flushing; Headache	FLU3~SANOFI PASTEUR~U1858EA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248640	12/02/2005	UT	44.0	44		F		Right shoulder and upper back became bright red and hot to touch 15 minutes after injection of influenza vaccine.									Y	11/11/2005	11/11/2005	0	NONE	PUB	PUB	UNK	UNK	UNK			1						1	Erythema; Feeling hot	FLU3~SANOFI PASTEUR~U1832BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248641	12/02/2005	VT	31.0	31		M	11/21/2005	Client broke out into hives 10 minutes after receiving a flu shot.									Y	11/10/2005	11/10/2005	0		OTH	PVT	UNK	UNK	UNK			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1816AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248642	12/02/2005	UT	53.0	53		M	11/18/2005	Rash, purple spots developed day after injection noted stiffness of extremities and heart palpitation also.										10/27/2005	10/28/2005	1		OTH	PVT	UNK	Cancer				1						1	Cardiac disorder; Musculoskeletal stiffness; Palpitations; Rash; Skin discolouration	FLU3~SANOFI PASTEUR~U1890AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248643	12/02/2005	UT	34.0	34		M	12/02/2005	Five minutes after receiving flu shot client c/o throat tightness, pressure behind eyes, heavy chest and itching. Given antihistamine referred to MD.										11/15/2005	11/15/2005	0		OTH	PVT	NONE	NONE				1						1	Chest pain; Eye disorder; Pruritus; Sensation of pressure; Throat tightness	FLU3~SANOFI PASTEUR~U1848AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248644	12/02/2005	UT	43.0	42		F	12/02/2005	Complained of tingling at arms and legs. Thick tongue, chills 25 minutes after flu shot, referred to MD.										11/10/2005	11/10/2005	0		OTH	PVT	UNK	UNK				1						1	Chills; Paraesthesia; Tongue disorder	FLU3~SANOFI PASTEUR~U1816AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248645	12/02/2005	TN	6.0	5		M	12/02/2005	No ill effects due to injection.									Y	11/11/2005				PVT	PVT		NONE				1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA153BA~1~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0248646	12/02/2005	CA	6.0	5		M	12/01/2005	Child Took Vax on 11/22. On 11/24 woke up fever 100.5, a few hours later started vomiting quite often, sneezing, coughing. felt better next day.									Y	11/22/2005	11/24/2005	2		PVT	UNK	Singular when needed		On and off allergies			1						1	Cough; Pyrexia; Sneezing; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~UNK~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0248615	12/03/2005	FL	57.0	57		F	12/03/2005	Two days after receiving the flu shot I developed severe pain in my throat, difficulty in swallowing, a sharp pain accompanies each time I swallow, soreness, terrible scratchy feeling each time I swallow along with pain. A stiff neck, no temperature. Fatigue, loss of appetite. This is the 7th day since I received the shot.									N	11/25/2005	11/27/2005	2		UNK	UNK	AVAPRO for blood pressure	None	none			1						1	Anorexia; Dysphagia; Fatigue; Musculoskeletal stiffness; Pain; Pharyngolaryngeal pain	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0248616	12/03/2005	NY	65.0	65		F	12/03/2005	About 4 hrs. after receiving flu shot I started a constant cough which lasted about 4 hrs. Then I had chills on & off for about two hrs. No fever & aside from those 2 symptoms felt OK. Next day just muscle aches from coughing along with a very dry mouth and not quite feeling up to par energy wise though I did put it a full days work. The day after that felt  normal.									Y	11/30/2005	11/30/2005	0		UNK	UNK	Hyzaar, Accuprel, Lipitor					1						1	Chills; Cough; Dry mouth; Myalgia	FLU3~PFIZER\WYETH~V1815AA~1~ID~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0248617	12/03/2005	TX	61.0	60		F	12/03/2005	PATIENT EXPERIENCED A RASH AT THE SITE OF INJECTION WHICH EXTENDED TO HER SHOULDER AND UPPER ARM. SHE ALSO EXPERIENCED SWELLING AND TIGHTNESS IN THE MUSCLE AT THE SITE OF INJECTION. THE RASH GRADUALLY DISAPPEARED IN APPROX. 7-10 DAYS. SHE STILL HAS A SLIGHT AMOUNT OF MUSCLE TIGHTNESS IN THE BACK OF THE BICEP WHEN SHE EXTENDS HER ARM. SHE TOOK TYLENOL AT THE ONSET OF REACTION BUT DID NOT TAKE ANY OTHER MEDS OR SEEK ANY TREATMENT FROM HER DOCTOR OR EMERGENCY CLINIC.									Y	11/12/2005	11/13/2005	1	NONE KNOWN	UNK	UNK	ZOLOFT 50MG, TRICOR 145MG, MAXZIDE-75/50, DILTIA XT 240MG.	NONE KNOWN	DIABETES, HIGH BLOOD PRESSURE, HIGH CHOLESTEROL			1						1	Injection site rash; Injection site swelling; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U1806AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248618	12/03/2005	NY	26.0	26		F	12/03/2005	Pt evaluated in emergency department for fever 103, fatigue, swollen, red left arm, swollen face and lips. Received pneumovax 11/30/05, same day also received infuenza vaccine in the right arm (no problems noted in that arm).				Y	Y	2			Y	11/30/2005	12/02/2005	2	blood cultures pending WBC 15.6 (patient on prednisone 10mg QOD)	UNK	UNK	prednisone10 mg po QOD lisinopril 20mg po QD acyclovir 400mg po BID multiple vitamin 1 po QD oral contraceptive pill	none	membranous proliferative glomerulonephritis type II herpes simplex			1						1	Face oedema; Fatigue; Injection site erythema; Pyrexia; Swelling	FLUX~UNKNOWN MANUFACTURER~~3~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0248619	12/04/2005		39.0	39		M	12/04/2005	Mild febrile illness with myalgias at 4-5 days post-vaccination, but then with onset of diffuse, pruritic, acneiform (pustular) rash on post-vaccine day 11.				Y					U	11/23/2005	12/04/2005	11	none -- physician examination/documentation	MIL	MIL	NONE	NONE	NONE			1						1	Dermatitis acneiform; Myalgia; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~2~IM~~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~2~IM~~HEP A (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~ID~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0248620	12/04/2005	MA	44.0	43		F	12/04/2005	R arm became severely painful,warm, red, edematous from upper arm down to hand.  Accompanied by fever.  Sx began few hours after flu vaccine administered and wosened with time.  Presentation consistent with cellulitis.  Required IV antibiotics twice in ER as well as course of PO antibiotics.				Y					Y	11/30/2005	11/30/2005	0		UNK	UNK	Levoxyl, Bupropion SR	Resolving mild,viral pharyngitis (afebrile)	Hypothyroidism, Latent TB, Non-Hodgkins Lymphoma (in remission x5 yrs), allergic rhinitis, Depression, S/P splenectomy			1						1	Cellulitis; Erythema; Injection site warmth; Oedema peripheral; Pain; Pyrexia	FLU3~SANOFI PASTEUR~u1914aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456p~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0248621	12/04/2005	OH	65.0	65		F	12/04/2005	It has been a month since I had the vaccine and I still have pain in the shoulder where the shot was given.  I have trouble lifting my arm up higher than my shoulder and also have pain when I lift objects with that arm. I have taken Tylenol, Naproxen, and have used both heat and cold on the affected arm.									N	11/01/2005	11/01/2005	0		UNK	UNK		None	Vitamin E Potassium (3 per day) Effexor (12.5 mg) Maxide (37.5 mg) Lipitor (20 mg) Cancer treatment for 5 weeks in 2002			1						1	Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U1833BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248622	12/04/2005	OH	67.0	66		M	12/04/2005	Severe pain in shoulder and back next day after shot was given on 11/01/05. Went to doctor on 11/07/05 and he prescribed a dose pack and muscle relaxant. Went back to doctor 11/14 or 15/05 prescribed pain meds.  Went to ER on 11/29/05 as pain had gotten worse, I felt this might be a heart attack.  Pain went from shoulder to neck and jaw area.  Discharged from ER after determining it was not heart related.  Pain is still in the left shoulder and surrounding area.				Y					N	11/01/2005	11/02/2005	1	Blood tests Ekg Xray hospital monitoring	UNK	UNK	Altace 5 mg Lipitor 10 mg Folbee Lasix 40 mg Plavix 75 mg Flomax 0.4 mg Lopressor 50 mg Flonase .05% Combivent  Ambien as needed Paxil 25 mg	None	May 2003 heart attack June 2003 angioplasty November 2004 5 stents March 2005 Gall bladder and appendix surgery (tumor with cancer in appendix)			1						1	Back pain; Pain in jaw; Shoulder pain	FLU3~SANOFI PASTEUR~U1833BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248623	12/04/2005	DE	71.0	70		F	12/04/2005	Vertigo, began 24 hours after administration, slowly resolved after weeks.									Y	11/09/2005	11/10/2005	1		UNK	UNK	Verapamil, Lisinopril, HCTZ, Prozac	No	NKDA, hypertension, depression.			1						1	Vertigo	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62013~1~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~07779~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248572	12/05/2005	MS	50.0	50		M	12/05/2005	FluMist nasal spray flu vaccine administered IM to deltoid.  Patient was a law enforcement responder detailed to hurricane relief duties at the time.  Nurse who administered vaccine was unaware of availability of nasal vaccine.  He broke off the tip of the syringe-like nasal spray devise and drew up .5 ml of the medication into a sterile syringe.  He then administered to the patient IM.  The error was discovered several hours later.  The patient was located and reported no adverse effects.  His vital signs, general health status, and the site of injection did not indicate any adverse reaction at any time over the following 5 days.  When contacted approximately 7 weeks after the event, there was still no indication of any adverse effects.  Although the patient reports no adverse effects from the mistake, it is being reported because the packaging of the product, using a syringe-like device to spray into nose, may be a contributing factor to the error and possibly could occur again.  The event was reported to the manufacturer immediately and apparently this was the first instance of IM injection of the FluMist.  I am a supervisor RN who was also deployed for hurricane relief.  I can be contacted to discuss the incident if need be.									Y	10/15/2005	10/15/2005	0		UNK	UNK	None	None reported	Unremarkable history			1						2	Medication error; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~1~~RA~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0248632	12/05/2005	NC	7.0	7		F	12/02/2005	Generalized hives and whelps - Urticarial allergy reaction plus eyelid swelling, writs/ankle swelling, intense pruritus.									Y	11/30/2005	11/30/2005	0	NONE	PVT	PVT		NONE	NONE			1						1	Eyelid oedema; Pruritus; Swelling; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62013~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0248674	12/05/2005	NY	72.0	72		M	11/28/2005	Information has been received from a physician concerning a 72 year old male with chronic obstructive pulmonary disease (COPD), a history of pneumonia (patient was hospitalized two weeks prior due to pneumonia) and no allergies who on 11/16/05 was vaccinated IM in the right arm with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 650082/0691P). Concomitant vaccination given on that same day included a dose of influenza virus vaccine. Concomitant therapy included fluticasone propionate, tiotropium bromide, zolpidem tartrate and fluticasone propionate, PRN. Within 24 hours of vaccination, on 11/17/05, the physician reported that the swelling was growing. Treatment with amoxicillin (+) clavulanate potassium and cold compresses was provided. The reporting physician stated that the patient may need to be hospitalized if the swelling did not improve. It was noted that prior to the vaccinations, the patient told the physician that he had not received the pneumococcal 23v polysaccharide vaccine, but post vaccination the patient stated that he may have been vaccinated with pneumococcal 23v polysaccharide vaccine recently. The reporting physician considered the adverse experience to be disabling and also considered it to be an other important medical event (OMIC). Additional information has been requested.				Y				Y	Y	11/16/2005	11/16/2005	0		OTH	OTH	Flovent; Flonase; Spiriva; Ambien		Pneumonia; Hospitalization		WAES0511USA03303	1						1	Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0691P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0248681	12/05/2005		62.0			F	12/01/2005	Information has been received from a registered nurse via a company representative concerning a 62 year old female who in Oct 2005, was vaccinated IM in the right deltoid with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 649693/0456P). Concomitant therapy included a dose of influenza virus vaccine (unspecified) administered in the left arm. It was reported that within 15 minutes of being vaccinated, the patients arm began to hurt. She described the pain as feeling like a bee sting. She had a 2-3 inch circle of swelling and redness at the injection site. The spot was warm to the touch. Within 2 hours, the 2-3 inch circle spread all the way from her shoulder to her elbow. She went to the emergency room and they gave her a methylprednisolone (Medrol) dose pack and discharged her. Subsequently, on an unspecified date on Oct 2005, the patient made a full recovery. There was no product quality complaint involved. It was reported that the patients first vaccination with pneumococcal 23v polysaccharide vaccine was five years ago. The reporter considered the patients experiences to be other important medical events (OMIC). Additional information had been requested.				Y					Y	10/01/2005	10/01/2005	0		OTH	OTH					WAES0511USA03757	1						1	Feeling hot; Injection site hypersensitivity; Injection site oedema; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0456P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0248682	12/05/2005		62.0	62		M	12/01/2005	Information has been received from a health professional concerning a 64 year old male who in October 2005, was vaccinated with a first 0.5ml IM dose in the right deltoid of pneumococcal 23v polysaccharide vaccine (lot # 649693/0456P). Concomitant therapy included atorvastatin calcium and concomitant vaccine administered on the same day included a dose in the left arm of influenza virus vaccine. In October 2005, about 3 hours after vaccination, the patient developed severe pain in his arm and he could barely move it. His arm was swollen and red. The patient went to the emergency room. He was given methylprednisolone and was discharged. It was reported that the patient made a full recovery. There were no laboratory or diagnostic tests performed. No product quality complaint was involved. The event was considered to be an other important medical event by the reporter (OMIC). Additional information has been requested.				Y					Y	10/01/2005	10/01/2005	0		OTH	OTH	Lipitor				WAES0511USA03790	1						1	Erythema; Hypokinesia; Pain; Swelling	FLU3~SANOFI PASTEUR~01854AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0248693	12/05/2005					F		A report was received from a healthcare professional on 17th November 2005, regarding a female vaccinee aged 32-40 years old. No details were provided regarding the vaccinee's medical history or concomitant medications. On 17th November 2005, the vaccinee received a Fluvirin vaccination intramuscularly,. Within 20 minutes the vaccinee experienced extreme flushing of the face, itching on her back, flushing, wooziness, shaking and sweating. The vaccinee did not go to hospital, but an observer said that she probably should have gone. The outcome of the vaccinee was unknown at the time of reporting. Follow up information received on 23rd November 2005 reported that the vaccinee returned to the site experiencing dizziness and feeling hot. Her blood pressure was checked at 12:30 pm the reading was 180/120, pulse 112-120. 911 was called. The vaccinee blood pressure was checked again and was 160/100, pulse 115. It was suggested that the vaccinee should go to her doctor. The vaccinee state that she felt like a migraine headache coming on. The vaccinee was not taken to hospital.									U	11/17/2005				UNK	UNK	NONE				CVOX2005200195	1						1	Dizziness; Flushing; Hyperhidrosis; Migraine; Pruritus; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62017~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0248694	12/05/2005					F		A report was received from a healthcare professional on Nov 17 2005, regarding a female vaccine aged 32-40 years old. No details were provided regarding the vaccine's medical history or concomitant medications. On Nov 17 2005, the vaccinee received a Fluvirin vaccination intramuscularly. The vaccinee returned to the site to report she feels dizzy. She was hot and her blood pressure was high. Patient laid down and then felt better. Follow up received on Nov 23 2005 stating the vaccine returned to the vaccination site to report she feels dizzy. BP 140/82 pulse 72. The vaccine was asked if she would like to lie down. The vaccine said yes. The healthcare professional then followed her to the hall (close by and more private) and helped her to lie down. The vaccine then said that she felt better. She complained of feeling hot BP reached 200 140/78 pulse 74. The vaccine had no rash and difficulty breathing.										11/17/2005	11/17/2005	0		UNK	UNK					CVOX200500196	1						1	Dizziness; Hot flush; Hypertension	FLU3~EVANS VACCINES~2017~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0248695	12/05/2005	HI	35.0	35		F	11/28/2005	This is a serious spontaneous case involving Bells Palsy. The reporter causality is possible to FluMist. A 35 year old nurse with previous history of Bell's palsy secondary to head trauma when she was 8 years old, experienced slurred speech, watery eyes, drooling at night while asleep, inability to close right side of mouth completely and swelling of right side of face 2 days after receiving FluMist vaccine on Nov 12 2005. She was seen by her primary physician who referred her to a neurologist. She was diagnosed with Bell's Palsy. She was treated with oral prednisone for 6 days and Valtrex (Valacyclovir) for one week. No diagnostic procedures or laboratory test were done. By Nov 18 2005, her symptoms had improved and as of Nov 28 2005, she had completely recovered. However, she stated that she is beginning to have an ear infection. She will see her primary physician regarding treatment. No signs and symptoms of other central nervous system disorder was reported. The reported assessed the events as possibly related to FluMist.									Y	11/12/2005	11/14/2005	2		PVT	PVT	Concomitant drugs not reported.	Head injury	Bell's Palsy, Asthma, Pollen allergy		MEDI0003872	1						1	Condition aggravated; Drooling; Dysarthria; Face oedema; Facial palsy; Lacrimation increased; Otitis media	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0248697	12/05/2005	OH	67.0	67		F	12/02/2005	Injection 4:30pm Nov 18, at 8:00pm throat started to swell with unbearable pain, tongue swelled and neck. ER, oxygen, Solu Medrol IV, Benadryl IV, Pepsin IV, Throat X ray, blood work.			Y	Y					Y	11/18/2005	11/18/2005	0		OTH	UNK	Diovan		Asthma;Emphysema;High Blood Pressure			1						1	Pain; Pharyngeal oedema; Tongue oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0248698	12/05/2005	NY	57.0	56		M	12/02/2005	24 hours after vaccine had edema / erythema / warmth of forearm deltoid.									U	11/29/2005	11/30/2005	1	NONE	PVT	PVT	Flovent;AccNeb;Nasonex	NONE	NONE			1						1	Erythema; Feeling hot; Oedema	FLU3~SANOFI PASTEUR~U1863AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248699	12/05/2005	GA	43.0	43		M	11/02/2005	Left arm shoulder stiffed up, couldn't raise arm. Taken Advil and Tylenol. Condition slowly improving but today still in pain.									U	11/15/2005	11/15/2005	0		OTH	PVT	50IU Medryl;Avonex;Prednisone;CellCept; Neurontin	NONE	Multiple Sclerosis			1						1	Hypokinesia; Musculoskeletal stiffness; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUAB9AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0248701	12/05/2005	MN	50.0	49		M	11/28/2005	Severe chest pain, tightness of breath, wheezing, cough with phlegm. Chills and fever (up to 40 degrees C) pain at muscle site joints. Patient came to EOHS with a slip from urgent care. Patient state he did the flu shot at EOHS on Mon noon. A cough of his later restarted experiencing chest pain and sob. This was followed with hot/cold sweats into the evening after dinner. He called the triage nurse at emergency room. She advised him to go to the urgent care - he did this. A copy of the report is in file. Vaccine Adverse Reporting System. He said the Dr on the slip said this was a reaction to the flu shot. Patient said however eh had a sore throat and cold for 2 wks prior to getting the flu shot. At Urgent Care he had blood test done which he indicated his white blood count was very high. He was put on an antibiotic and state he felt better after taking this. He had coughing with phlegm prior to the flu shot. Advised since he is on antibiotic he should follow-up with his PMD before the antibiotics is gone as if needs to cont. with antibiotic and be evaluated. 11/25/05 call patient -  completed medications but was unable to talk on cell phone will call me back to discuss current health state. 11/28/05 Symptoms 2 wk prior to when rec'd flu vaccine includes cough, mild sore throat, felt fine the day of vaccinations. Advised patient to consult PMD concerning future vaccines and allow them to administer if still recommended. 11/28/05 no symptoms. 11/29/05 Appt with Primary MD.				Y					Y	11/21/2005	11/21/2005	0	Blood test;Chest X-ray;EKG	PUB	PVT			NONE			1						1	Arthralgia; Chest pain; Chills; Cough; Dyspnoea; Hyperhidrosis; Myalgia; Pyrexia; Wheezing	FLU3~SANOFI PASTEUR~U1870AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248702	12/05/2005	CA	76.0	75		M	11/29/2005	Sudden severe paint and stiffness (next day after shot) in shoulder joints, hip joints, knee joints and leg thigh, pain in elbows. Four weeks later still extreme pain and stiffness. Described pain relievers were not effective. No severe health problems before flu shot.										10/20/2005	10/31/2005	11		PVT	UNK	Micardis	NONE				1						1	Joint stiffness; Pain	FLU3~SANOFI PASTEUR~U777AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248703	12/05/2005	TN	20.0	19		F	11/29/2005	Swelling and erythema of face approx. 2 hrs post administration. Resolved within 2 hrs post administration of Allegra 180. No further symptoms									Y	11/25/2005	11/25/2005	0		PVT	OTH	NONE	NONE	Allergy to Ceftin			1						1	Erythema; Swelling	FLUN3~MEDIMMUNE VACCINES, INC.~500426P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0248704	12/05/2005	OH	85.0	85		F	11/25/2005	Monday am shot given and redness and swelling increase that evening right upper of arm, to fingers . Did not notify MD. Advised to call MD and will today. Upper swelling has gone down right elbow decrease.  Including swelling Thurs 11/24/05 to fingers.										11/21/2005	11/21/2005	0		PUB	UNK						1						1	Erythema; Swelling	FLU3~SANOFI PASTEUR~U1824AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0607R~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248705	12/05/2005	PA	58.0	57		M		11/16/05 Swelling and pain. Severe local reaction at Pneumovax site									Y	11/15/2005	11/16/2005	1		PVT	PVT		NONE				1						1	Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1910AA~3~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0877R~2~SC~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248706	12/05/2005	IL	83.0	83		F	11/22/2005	Upper arm swollen, redness. Antibiotic. Dx Cellulitis upper left arm.				Y					Y	11/09/2005	11/12/2005	3		OTH	OTH	Norvasc;Actonel;Lipitor;Protonix	NONE	HTN;High Cholesterol;Osteopenia			1						1	Cellulitis; Erythema; Oedema	FLU3~SANOFI PASTEUR~U1802AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248707	12/05/2005	PA	7.0	6		M	11/28/2005	Bell's Palsy- received flu vaccine 11/11/05 - developed Bells palsy 11/16/05-  negative lyme titers and EBV titers									Y	11/11/2005	11/16/2005	5	Negative Lyme and EBV Titers	PVT	PVT	NONE					1						1	Facial palsy	FLU3~SANOFI PASTEUR~U1900AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248708	12/05/2005	CT	1.01	1	.0	M	11/29/2005	11-28-05 Rash developed. 11-25-05 Fever developed on Amoxil, antibiotic change to Zithromax. 11-27-05 Phone call from mother pt has white patches on throat advised to be seen if no improvement. 11-29-05 Dx with measles vaccine reaction also with acellular ataxia at time of vaccine.									U	11/16/2005	11/28/2005	12	NONE	PVT	PUB		B.O.M.;Rhinitis; Dx at well visit	NONE			1						1	Pyrexia; Rash	FLU3~SANOFI PASTEUR~U1788BA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0562R~1~IM~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0248709	12/05/2005	TN	26.0	25		M	11/16/2005	Flu and Pneumonia vaccine give in same syringe currently in process of re-vaccinating per CDC. No adverse effects.										10/22/2005	10/22/2005	0		OTH	PUB		ESRD	NONE			1						1	Medication error	FLU3~SANOFI PASTEUR~U1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248710	12/05/2005	CA				M		Chills, fever, ache, sore eyes, cough, runny nose, productive cough.									U	11/07/2005	11/09/2005	2		PUB	PUB						1						1	Chills; Cough; Eye pain; Pyrexia; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0248711	12/05/2005	NY	1.01	1	.0	F	11/29/2005	Left arm posterior, upper immediate red, raised area on skin with hard knot-like area palpable in center of area. Given Benadryl (1mg 1kg) and monitored 1 our post vaccine. Will call tomorrow to check reaction site.										11/29/2005	11/29/2005	0	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U1788GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0610P~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A94456F~4~IM~RA~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0437P~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0248712	12/05/2005	CT	51.0	51		F	11/30/2005	At approx 8:30 pm on 11/16 I became very tired and went to bed. I woke up at 2:00 am felt very heavy. At 5:30 am got up out of bed with much difficulty and went to bathroom. Eyes almost swollen shut. Got into shower and blacked out. Got to bed could hardly move. Had difficulty breathing, talking or moving. Arm and hands were very swollen, tongue was very thick. When tried to sit or stand I was very dizzy. I was very pale and weak. Spent two days in bed. Still very tired, neck, arm shoulder hurting. When the PA gave me my shot she poked me three times.									U	11/16/2005	11/16/2005	0		PVT	OTH		NONE	Allergies to sulfa and Levaquin. Suffer from Fibro Myalgia			1						1	Asthenia; Dizziness postural; Dyspnoea; Eye swelling; Loss of consciousness; Movement disorder; Oedema peripheral; Pallor; Sensation of heaviness; Speech disorder; Tongue disorder	FLU3~SANOFI PASTEUR~U1935AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248713	12/05/2005	CT	43.0	43		F	11/23/2005	Given Thursday, 11/17/05. On Friday and Saturday, 11/18/05 and 11/19/05, area size of silver dollar on left deltoid, reddened, hard and hot to touch as reported by patient. States she applied warm soaks - no medical care sought. Not observed by nurse. Area checked on 11/23/05; appears normal, left deltoid area flat, soft with normal skin tones - no marks.									Y	11/17/2005	11/18/2005	1		UNK	UNK		NONE	Penicillin; Tetra; EES; Sulfa; Biaxin; Ceclor			1						1	Injection site erythema; Injection site induration; Injection site warmth	FLU3~SANOFI PASTEUR~U1916AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248714	12/05/2005	TN	66.0	65		M	11/17/2005	Flu and pneumonia vaccine given in same syringe. Currently in progress of re-vaccinating per CDC.										10/22/2005	10/22/2005	0	NONE	OTH	PUB	NONE	ESRD	NKA			1						1	Medication error	FLU3~SANOFI PASTEUR~V1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248715	12/05/2005	TN	87.0	87		F	11/17/2005	Flu and Pneumonia vaccine given in same syringe. Currently in process of re-vaccinating per CDC.									U	10/22/2005			NONE	OTH	PUB	NONE	ESRD	NKA			1						1	Medication error	FLU3~SANOFI PASTEUR~V1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~10B8P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248716	12/05/2005	TN	79.0	79		M	11/17/2005	Flu and Pneumonia vaccine given in same syringe. Currently in process of re-vaccinating per CDC.									U	10/22/2005			NONE	OTH	PUB	NONE	ESRD	NKA			1						1	Medication error	FLU3~SANOFI PASTEUR~U1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248717	12/05/2005	TN	64.0	63		M	11/17/2005	Flu and Pneumonia vaccine given in same syringe. Currently in process of re-vaccinating per CDC.									U	10/22/2005			NONE	OTH	PUB	NONE	ESRD	NKA			1						1	Medication error	FLU3~SANOFI PASTEUR~U1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248718	12/05/2005	TN		72		F	11/17/2005	Flu and Pneumonia vaccine given in same syringe. Currently in process of re-vaccinating per CDC.									U	10/22/2005			NONE	OTH	PUB	NONE	ESRD	NKA			1						1	Medication error	FLU3~SANOFI PASTEUR~U1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248719	12/05/2005	TN		40		M	11/17/2005	Flu and Pneumonia vaccine given in same syringe. Currently in process of re-vaccinating per CDC.									U	10/22/2005			NONE	OTH	PUB	NONE	ESRD	NKA			1						1	Medication error	FLU3~SANOFI PASTEUR~V1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248720	12/05/2005	TN		84		M	11/17/2005	Flu and Pneumonia vaccine given in same syringe. Currently in process of re-vaccinating per CDC.									U	10/22/2005			NONE	OTH	PUB	NONE	ESRD	NKA			1						1	Medication error	FLU3~SANOFI PASTEUR~V1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248721	12/05/2005	ID	46.0	46		F	11/17/2005	Flu and Pneumonia vaccine given in same syringe. Currently in process of re-vaccinating per CDC.									U	10/22/2005	10/22/2005	0	NONE	OTH	PUB		ESRD	NKA			1						1	Medication error	FLU3~SANOFI PASTEUR~U1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248722	12/05/2005	TN	72.0	72		F	11/17/2005	Flu and Pneumonia vaccine given in same syringe. Currently in process of re-vaccinating per CDC.									U	10/22/2005	10/22/2005	0	NONE	OTH	PUB	NONE	ESRD	NKA			1						1	Medication error	FLU3~SANOFI PASTEUR~V1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248723	12/05/2005	TN	72.0	71		F	11/17/2005	Flu and Pneumonia vaccine given in same syringe. Currently in process of re-vaccinating per CDC.									U	10/22/2005	10/22/2005	0	NONE	OTH	PUB	NONE	ESRD	NKA			1						1	Medication error	FLU3~SANOFI PASTEUR~V1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248724	12/05/2005	TN	49.0	48		M	11/17/2005	Flu and Pneumonia vaccine given in same syringe. Currently in process of re-vaccinating per CDC.									U	10/22/2005	10/22/2005	0	NONE	OTH	PUB	NONE	ESRD	NKA			1						1	Medication error	FLU3~SANOFI PASTEUR~V1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248725	12/05/2005	TN	71.0	71		M	11/17/2005	Flu and Pneumonia vaccine given in same syringe. Currently in process of re-vaccinating per CDC.										10/22/2005	10/22/2005	0	NONE	OTH	PUB	NONE	ESRD	NKA			1						1	Medication error	FLU3~SANOFI PASTEUR~V1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248726	12/05/2005	TN	21.0	21		M	11/17/2005	Flu and Pneumonia vaccine given in same syringe. Currently in process of re-vaccinating per CDC.									U	10/22/2005	10/22/2005	0	NONE	OTH	PUB	NONE	ESRD	NKA			1						1	Medication error	FLU3~SANOFI PASTEUR~V1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248727	12/05/2005	TN	65.0	64		M	11/17/2005	Flu and Pneumonia vaccine given in same syringe. Currently in process of re-vaccinating per CDC.									U	10/22/2005	10/22/2005	0	NONE	OTH	PUB	NONE	ESRD	NKA			1						1	Medication error	FLU3~SANOFI PASTEUR~V1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248728	12/05/2005	TN	43.0	43		M	10/17/2005	Flu and Pneumonia vaccine given in same syringe. Currently in process of re-vaccinating per CDC.									U	10/19/2005			NONE	OTH	PUB	NONE	ESRD	NKA			1						1	Medication error	FLU3~SANOFI PASTEUR~V1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248729	12/05/2005	TN	41.0	41		F	11/16/2005	Flu and pneumonia vaccine given in same syrinage. Currently in process of re-vaccinating per CDC. No adverse effects.									Y	10/20/2005	10/20/2005	0		OTH	PUB		ESRD				1						1	Medication error	FLU3~SANOFI PASTEUR~U1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248730	12/05/2005	TN	78.0	78		M	11/01/2005	Flu and pneumonia vaccine given in same syrinage. Currently in process of re-vaccinating per CDC. No adverse effects.									Y	10/28/2005	10/28/2005	0		OTH	PUB		ESRD				1						1	Medication error	FLU3~SANOFI PASTEUR~U1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248731	12/05/2005	TN	54.0	54		M	11/17/2005	Flu and pneumonia vaccine given in same syringe. Currently in process of re-vaccinating per CDC. No adverse effects.									Y	10/22/2005				OTH	PUB		ESRD	NKA			1						1	Drug administration error; Vaccination failure	FLU3~SANOFI PASTEUR~U1763AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248732	12/05/2005	TN	63.0	62		F	11/17/2005	Flu and pneumonia vaccine given in same syringe. Currently in process of re-vaccinating per CDC. No adverse effects.									Y	10/22/2005	10/22/2005	0		OTH	PUB		ESRD				1						1	Medication error	FLU3~SANOFI PASTEUR~U1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248733	12/05/2005	TN	41.0	40		F	11/17/2005	Flu and Pneumonia vaccine given in same syringe currently in process of re-vaccinating Per CDC.										10/22/2005	10/22/2005	0		OTH	PUB						1						1	Medication error	FLU3~SANOFI PASTEUR~U1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248734	12/05/2005	TN	59.0	58		M	11/17/2005	Flu and Pneumonia vaccine given in same syringe currently in process of re-vaccinating Per CDC										11/22/2005	11/22/2005	0		OTH	PUB		End stage renal disease				1						1	Medication error	FLU3~SANOFI PASTEUR~U1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248735	12/05/2005	TN	60.0	59		F	11/17/2005	Flu and Pneumonia vaccine given in same syringe currently in process of re-vaccinating Per CDC										10/22/2005	10/22/2005	0		OTH	PUB		End stages renal disease				1						1	Medication error	FLU3~SANOFI PASTEUR~U1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248736	12/05/2005	TN	61.0	61		F	11/17/2005	Flu and Pneumonia vaccine given in same syringe currently in process of re-vaccinating Per CDC										10/22/2005	10/22/2005	0		OTH	PUB		End stages renal disease				1						1	Medication error	FLU3~SANOFI PASTEUR~U1736AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248737	12/05/2005	TN	50.0	49		M	11/17/2005	Flu and Pneumonia vaccine given in same syringe currently in process of re-vaccinating Per CDC										10/22/2005	10/22/2005	0		OTH	PUB		ESRD				1						1	Medication error	FLU3~SANOFI PASTEUR~U1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248738	12/05/2005	TN	61.0	61		F	11/17/2005	Flu and Pneumonia vaccine given in same syringe currently in process of re-vaccinating Per CDC										10/22/2005	10/22/2005	0		OTH	PUB		ESRD				1						1	Medication error	FLU3~SANOFI PASTEUR~U1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248739	12/05/2005	TN	74.0	74		M	11/17/2005	Flu and Pneumonia vaccine given in same syringe currently in process of re-vaccinating Per CDC										10/22/2005	10/22/2005	0		OTH	PUB		ESRD				1						1	Medication error	FLU3~SANOFI PASTEUR~U1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248740	12/05/2005	TN	84.0	84		F	11/17/2005	Flu and Pneumonia vaccine given in same syringe currently in process of re-vaccinating Per CDC										10/22/2005	10/22/2005	0		OTH	PUB		ESRD				1						1	Medication error	FLU3~SANOFI PASTEUR~U1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248741	12/05/2005	FL	59.0	59		F	11/28/2005	States noted 11/24/2005 early afternoon sharp pain in left anterior chest, later able to feel in posterior chest.				Y						11/21/2005	11/24/2005	3		PUB	PVT	Lisinopril, HCTZ		Ibuprofen allergy, hypertension			1						1	Chest pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61320~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0248742	12/05/2005	TN	64.0	64		M	11/11/2005	Flu and Pneumonia vaccine given in same syringe currently in process of re-vaccinating Per CDC										10/22/2005				OTH	PUB		ESRD				1						1	Medication error	FLU3~SANOFI PASTEUR~U1763AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248743	12/05/2005	MD	77.0	76		M	11/29/2005	Flu shot Rec'd 7:30pm. Diarrhea started at 4:00am 11/09. took Imodium but loose bowel movements continued until about noon that day. slight headache but relieved with aspirin.									Y	11/09/2005	11/10/2005	1		PUB	PUB		NONE	NONE			1						1	Diarrhoea; Headache	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0248744	12/05/2005	MA	99.0	98		M	11/29/2005	Left arm at site of injection occurred 1 week after vaccine admin. Intermittent pain for 2 weeks. No treatment.									Y	11/07/2005	11/14/2005	7		PUB	PUB			NONE			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U1831AB~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248745	12/05/2005	AL	74.0	74		M	10/02/2005	Severe itch all over body with tongue swelling. Treated with Epi and Benadryl sent home. No further problems. Left town x 3 weeks after receiving flu shot. Contact made due to this.				Y					Y	10/19/2005	10/19/2005	0	NONE	PUB	PUB		NONE	NONE			1						1	Pruritus; Tongue oedema	FLU3~SANOFI PASTEUR~U1811AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248746	12/05/2005	WA	53.0	52		F	11/07/2005	Itchy, burning feeling across shoulder after vaccination generalized itching on trunk has had same S/S after using hot tub. Used hot tub pm 11/04/2005 broke in hives pt took Sudafed and felt better.									U	10/31/2005	10/31/2005	0		PUB	PUB		NONE			WA052129	1						1	Pruritus; Skin burning sensation; Urticaria	FLU3~SANOFI PASTEUR~U1904AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248747	12/05/2005	PA	49.0	48		F	11/09/2005	Developed numbness and tingling in all 10 digits hands and feet 11/08/2005 at 3am that had progressed to affecting the entire hands, and predominantly plantar aspect of feet. Feels weak. Unstable with Romberg testing. Able to stand and walk.									U	11/07/2005	11/08/2005	1	CBC, CMP, CRP, ESR, Vit B12, TSH, SBV, IGG, IGM, RPR,  blood gas.	PUB	UNK		Sinusitis, LCPD, RAD, anxiety	Mononucleosis			1						1	Asthenia; Balance disorder; Hypoaesthesia; Paraesthesia	FLU3~SANOFI PASTEUR~01863AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248748	12/05/2005	MI	56.0	55		F	11/07/2005	Patient states she received a flu shot at the ICHD on 10/28/05 at 4:00-4:30 pm. She states that she felt weird after getting the shot. State weird means her face felt tight but she didn't pay attention. She was visiting her sister who was a patient at medical center that evening. While at hospital she laid down between 8-9 pm, preparing to spend the night with her sister. States she immediately began to have swelling of her lips, tongue, eyes and neck. She states that her eyes were very bloodshot. She was taken down to Emergency Department, where she was given an IV. She was sent home on prednisone for 5 days, 3 days of Tagamet and 3 days of Benadryl. Symptoms resolved. Medicine course was completed and symptoms returned 2 days later. Patient went to hospital, where she states she was given a prednisone shot and was sent home with 7 days of Benadryl, Tagamet and prednisone. Today she is on day 3 of the 2nd medicine course and feels well. Requested medical records from hospital and IRMC ER on 11/08/05.				Y					Y	10/28/2005	10/28/2005	0		PUB	PUB			NONE		M12005039	1						1	Eye swelling; Feeling abnormal; Ocular hyperaemia; Swelling face; Tongue oedema	FLU3~SANOFI PASTEUR~U1810AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248749	12/05/2005	MI	83.0	83		M	11/21/2005	C/O pain at the injection site that evening 10/19/05. 10/20/05 arm felt heavy, not red and swollen. Continued to get worse swelling from deltoid right arm to fingers. Called son went to ER on 10/22. IV antibiotics times 3 days. PO antibiotic times 7 days per PCP. Recovery took 2-3 weeks now feels well.				Y					Y	10/19/2005	10/19/2005	0		PVT	PUB	DES/Diuretic	NONE	DES/Diuretic		M12005038	1						1	Injection site pain; Sensation of heaviness; Swelling	FLU3~SANOFI PASTEUR~U1836AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0790P~2~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0248750	12/05/2005	GA	4.0	4		F	12/01/2005	Shots given Tuesday 11-29-05. Mom called 12-1-05 leg large amount redness and swelling - limping. Tx Motrin, cool soaks, observe. Expect 3-5 days to resolve.				Y						11/29/2005	12/01/2005	2		PVT	PVT	MiraLax;Oxistat prescribed 11-29-05	Constipation				1						1	Erythema; Hypotonia; Swelling	DTAP~SANOFI PASTEUR~C2253AA~5~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1815AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0639P~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0248751	12/05/2005	IN	11.0	11		F	12/02/2005	Patient received Adacel vaccine and had swelling to the arm. Patient's parents consulted with their family physician and was diagnosed with a local reaction.				Y					Y	11/01/2005	11/16/2005	15	NONE	PUB	PUB	UNK	NONE	NONE			1						1	Swelling	FLU3~SANOFI PASTEUR~U1849AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2124AA~1~IM~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~0427R~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0248753	12/05/2005	CA	48.0	48		M	11/30/2005	Pt c/o pain on left deltoid, pain and fever times 2 days. Pt was treated with Septra by mouth and dicloxacillin.									U	11/28/2005	11/28/2005	0		PUB	PUB		Infection	Diabetes Mellitus			1						1	Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1807AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1004D~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TTOX~SANOFI PASTEUR~U1221BA~1~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0248754	12/05/2005	WA	0.57	0	.6	M	11/29/2005	Fever 103 11/29/05 02:21 mom called consulting nurse at hospital, mom and dad gave Motrin. 6 month old with 103 degree temp, mom calling patient had 4 immunizations today, just woke up with fever, rectal temp 102, alert and active, movement of extremities times 4, took bottle, no rashes, wetting diapers, no difficult  breathing, DTP,Hib PCV, flu shot, concerned about how high fever is. For fevers > 102 F (38.9 C) give acetaminophen every 4 hours or Ibuprofen every 6 hours. Call back if fever (temperature > 100.4 F) lasts > 3 days. Pains lasts > 3 days. Caller will comply with recommended disposition.									Y	11/28/2005	11/29/2005	1		PVT	UNK			NONE			1						1	Pyrexia	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC148005AA~2~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1743NA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE476AA~2~IM~LL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~Y0325~2~SC~LL~POLIO VIRUS, INACT. (POLIOVAX)~1|PNC~PFIZER\WYETH~94451H~2~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0248755	12/05/2005	AK	57.0	56		M	11/28/2005	Hives all over body									N	11/10/2005	11/12/2005	2		PUB	PUB		NONE	Cipro;Dilantin;Rheumatoid arthritis		AK200587	1						1	Urticaria	FLU3~SANOFI PASTEUR~U1754AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248756	12/05/2005	IL	52.0	52		M	11/14/2005	left arm neuralgia				Y					N	09/30/2005	10/01/2005	1		PVT	UNK			DM, HTN, asa, pcn, sea food			1						1	Neuralgia	FLU3~SANOFI PASTEUR~U1810AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248757	12/05/2005	CA	0.51	0	.5	F	11/30/2005	11:00 shots. 11:30 swollen left eye. 12:00 Emergency room visit. Eye swollen shut. Red hives on back, neck and stomach. Benadryl injection.				Y					U	11/18/2005	11/18/2005	0		PVT	PVT	infant tylenol					1						1	Eye oedema; Urticaria	DTP~PFIZER\WYETH~PC21B022CA~3~~~DTP (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1816AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~UNKNOWN MANUFACTURER~~3~~~HEP B (NO BRAND NAME)~1|OPV~PFIZER\WYETH~~3~~~POLIO VIRUS, ORAL (NO BRAND NAME)~1|PNC~PFIZER\WYETH~A94440H~3~~~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0248794	12/05/2005	NY	24.0	23		F	12/05/2005	Received vaccine at 4:19pm and felt ill at 10:00 pm that eve. Reports fever, chills, achy  bones, Headache, lethargy/fatigue. Sudden onset of sxs. Took Advil and slept. Able to attend college in am but remained fatigued and achy. No fever in am.									Y	11/15/2005	11/15/2005	0		UNK	UNK	none	none	None but states she was diagnosed with mercury poisoning in January, 2005.  Fine now.			1						1	Chills; Fatigue; Headache; Lethargy; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1836AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248795	12/05/2005	NM	55.0	55		F	12/05/2005	Extreme body aches everywhere Weakness and chills 3rd day aching joints									Y	11/30/2005	12/01/2005	1		UNK	UNK						1						1	Arthralgia; Asthenia; Chills; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62017~UNK~ID~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0248797	12/05/2005	NC	63.0	62		F	12/05/2005	Sharp pain at site of injection, beginning immediately at time of injection; patient reports no swelling, redness, fevers/chills/sweats or other signs of infection; patient says area is constantly tender to palpation and painful, regardless of movement of arm.									N	10/24/2005	10/24/2005	0	Advised patient to see her primary care physician for further workup;  has not gone as of this time.	UNK	UNK	None	None	None			1						1	Injection site pain; Pain; Palpitations	FLU3~SANOFI PASTEUR~U1904AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248798	12/05/2005	NM	31.0	31		F	12/05/2005	Fever. Blood in urine 24 hours after.				Y					Y	11/30/2005	12/01/2005	1	Urine culture and sensitivity: Negative for growth	UNK	UNK		none	none			1						1	Blood urine; Pyrexia	FLU3~SANOFI PASTEUR~U1868AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248799	12/05/2005	WI	23.0	23		F	12/05/2005	Pt has muscle aches fever of 103.				Y					U	12/04/2005	12/05/2005	1		MIL	MIL	Singulair Prevacid Nasacort	Pt claims none	Pt claims none			1						1	Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1882AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248800	12/05/2005	MI	1.08	1	.1	M	12/05/2005	Pt developed vesicular rash on erythematous base 11 days after varicella vaccination.				Y					U	11/21/2005	11/30/2005	9		UNK	UNK	none	none	none			1						1	Rash erythematous; Rash vesicular	FLU3~SANOFI PASTEUR~u1826aa~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~ue770aa~4~IM~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0165p~1~IM~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0065r~1~IM~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0248802	12/05/2005	MN	69.0	69		F	12/05/2005	Broke out in hives within 24 hours and by the third day she was covered on the upper part of her body along with her arms and legs.  Her daughter a dermotologist started her on oral medication and an ointment.  There wasn't a change in food, laundry soap or medication.									Y	11/15/2005	11/16/2005	1		UNK	UNK	Vitamin, ASA 1/2 of a 325 mg tablet, Calcium, Niacin 500 mg daily		Allergy:  Codeine, Levaquin CAD, Hyperlipidemia			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1870AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248803	12/05/2005	CA	25.0	25		F	12/05/2005	Fine systemic papular rash sparing anterior trunk beginning near injection site approx. 24 hours after influenza vaccine.									Y	11/30/2005	12/01/2005	1	None	MIL	PVT	Orthocyclen	No acute illness	Denies.	Rash~Measles + Mumps + Rubella (no brand name)~1~0.00~Patient		1						1	Rash papular	FLU3~SANOFI PASTEUR~U1865AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248804	12/05/2005	VA	53.0	52		F	12/05/2005	Vaccine administered at approx.3:45pm 0n 11/08/05 At approx. 7:15pm My throat started to feel like someone was cutting it with a knife and I became hoarse. Maybe 15 minutes later I began to have labored breathing as if something was heavy on my chest. At this time I was in bed laying down trying to take a nap. I got up and went to the bathroom and in the mirror I could see my bottom lip was swollen about 4-5 times its normal size and my scalera in both eyes were beet red. I was due to work overtime on the 11-7 shift and went on. By the time I got there I was having chills and sharp needle pains in my legs, arms, neck, head and in my back. I was sent to the emergency room by the night supervisor. When I got there I had a fever of 102.0. I was given Benadryl and Tylenol and was discharged several hours later. I am having bouts of fatigue since then.				Y					U	11/08/2005	11/08/2005	0		UNK	UNK		NO ILLNESS	ASTHMA, HYPERTENSION, ALLERGIC TO PENICILLIN			1						1	Chest pain; Chills; Dysphonia; Dyspnoea; Face oedema; Fatigue; Ocular hyperaemia; Paraesthesia; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U1828AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248806	12/05/2005	CA	68.0	68		F	12/05/2005	Approximately 3 weeks after vaccination, patient developed myalgias, arthralgias, joint swelling, malaise, and severe blisters and swelling of her upper and lower lips.  She did not seek medical attention and symptoms have completed resolved by today (except for some residual inflammation and scarring of the lips) by my exam of the patient today.  Patient is concerned and convinced that symptoms are related to vaccine. However, I (her physician) am not convinced of a relation between the vaccine and her symptoms.  However, having not had the opportunity to examine the patient at the height of her symptoms, I am at a clinical disadvantage.									Y	10/27/2005	11/21/2005	25		UNK	UNK	Zocor, Cozaar, Plendil, Elocon cream, Aspirin, Fish oil supplement, Calcium, Vitamin D, Vitamin B12	None documented.	Hypertension, diabetes, dyslipidemia, carotid artery atherosclerosis, atopic dermatitis.			1						1	Arthralgia; Blister; Face oedema; Joint swelling; Malaise; Myalgia	FLU3~SANOFI PASTEUR~U1775AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248807	12/05/2005	TX	58.0	57		F	12/05/2005	Severe pain at injection site, which was very high on shoulder. Pain and weakness in arm from the day shot was given, 11-7-05, through 11-24-05. Unable to reach across or above body without significant pain in shoulder. From 11-24-05 through 11-26-05, I immobilized my arm and applied heat continuously. Pain was reduced, but I still have discomfort raising my arm above my head. It feels as if the rotator cuff might have been injured.									N	11/07/2005	11/07/2005	0	None	UNK	UNK						1						1	Hypokinesia; Injection site pain; Muscular weakness; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0248820	12/05/2005	NC	5.0	4		M	12/05/2005	Right arm - red, swelling, fever about 4 inches down the arm ( 10 pm on 12/03/05 ) gave 1 teaspoon benadryl									Y	12/02/2005	12/03/2005	1		PUB	PUB						1						1	Erythema; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U1836AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248821	12/05/2005	IN	43.0	42		F	12/02/2005	Arm red - warm, hot to touch, painful. Started on Tequin on 12-2-05.									Y	11/28/2005				PVT	PVT		NONE				1						1	Erythema; Feeling hot; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~6201B~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~10416P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248822	12/05/2005	CA	50.0	49		M	12/05/2005	The patient was given the incorrect vaccine. Patient should of been given Tdap ( Adacel ). He was given Tdap ( Boostrix ) for adolescent use only									Y	11/30/2005	11/30/2005	0		PVT	OTH						1						1	Medication error	FLU3~SANOFI PASTEUR~U1868AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~038P~1~~RA~PNEUMO (PNEUMOVAX)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B001AA~1~~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0248823	12/05/2005	SC	19.0	19		F	11/21/2005	Vaccine administered approx. 8:30 am. Client left room of administration and immediately felt. Had tingling and drawing of both hands, increase shallow respirations and pallor. 8:40 am pulse 123 resp 28  8:55 pulse 90 resp 23 b/p 100/60  9:10 am pulse 84 resp 20 B/P 100/62. Extreme stiffness of hands									Y	11/18/2005	11/18/2005	0		PUB	PUB			sulfur drugs, green dye			1						1	Dyspnoea; Joint stiffness; Muscle spasms; Pallor; Paraesthesia	FLU3~SANOFI PASTEUR~U187288~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247509	12/06/2005	IA	77.0	77		F	11/10/2005	Pneumonia vaccine administered 10/31 in right deltoid. Developed right arm swelling 10/31 through 11/04, sore. Unable to use right arm.									Y	10/31/2005	10/31/2005	0		PUB	UNK			UNK			1						2	Feeling hot; Hypokinesia; Pain; Swelling; Hypokinesia; Pain; Swelling; Hypokinesia; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0792P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~0792P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~2|PPV~MERCK & CO. INC.~0792P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~3	USA		Influenza
0247722	12/06/2005	MO	3.0	2	.8	M	11/22/2005	Mom states less than 24 hours after flu shot, patient had seizures and was seen at hospital. Patient had no history of seizures, but had had flu shots for 3 years per mom.				Y					U	11/01/2005	11/02/2005	1	EEG	PUB	UNK						1						2	Convulsion; Rash; Convulsion	FLUX~UNKNOWN MANUFACTURER~~UNK~~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1805AA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0248816	12/06/2005	CA	4.0	4		M	11/30/2005	Cellulitis at site of immunization with Tetanus vaccine. Excellent response to antibiotic rx.				Y					Y	11/28/2005	11/29/2005	1		PUB	PUB		NONE	Afebrile seizure			1						1	Cellulitis; Injection site reaction	DTAP~SANOFI PASTEUR~C2184AA~5~~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1828AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1191~4~~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0485R~2~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0248817	12/06/2005	NH	62.0	61		F		Chills, fever, general malaise, achy feeling entire body lasting 5 days.									Y	11/10/2005	11/10/2005	0		PVT	UNK	Allegra; Actonel; Advair; Naprosyn; Lisinopril	NONE				1						1	Chills; Malaise; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62013~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0248818	12/06/2005	CA	60.0			F	12/09/2005	60 year old female history of SLE came here after getting Flu shot vaccine with ascending numbness in both lower extremities.				Y					U				MRI spine patchy abnormal involvement C2, C3, C4 without cord expansion of volume loss consist of myelitis.	OTH	UNK		Numbness started from lower Extremities				1						1	Hypoaesthesia; Myelitis	FLU3~SANOFI PASTEUR~UNK~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248819	12/06/2005	OR	0.54	0	.5	M		Baby was given vaccines at 9:45am. Parents then took him to a public pool. He developed rash, red, blotchy on trunk, most prominent axillae diaper area. Returned to office 12:15pm. Given Benadryl about 1 hour later rash was gone never recurred, even after going to pool again.				Y					Y	09/21/2005	09/21/2005	0	NONE	PVT	PVT	NONE	NONE	He vomits rice and oatmeal cereals			1						1	Erythema; Rash; Rash macular	DTAP~SANOFI PASTEUR~C2253AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U17436A~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y04592~3~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~A74406~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0248833	12/06/2005	SC	36.0	35		F	12/06/2005	After influenza vaccine given on 11-7-05. At 4 pm on 11-9-05 developed generalized rash with extreme itching during night hours. On Friday and into Friday night on 11-11-05 experienced generalized ache.  Saturday night experienced onset of tingling in arms, every joint hurt with stiffness.  Sunday, nov. 13th, temperature of 99.6; pain more severe with difficulty walking - joints more painful and reddened.  Seen by nurse practitioner who made diagnosis of flu vaccine reaction.  Prescribed Naproxen 275 mgm - 2 tabs am and pm; Tramadol 50 mgm - 1-2 tabs q 4hrs.  Had better day on the 14th (Monday), but experienced painful joints and sleeplessness Monday night.  Back of neck and particularly joint in right arm painful - continued on Tuesday, the 15th. Returned to work on wednesday, Nov. 16th, right arm pain continued.  Report from lab work done was within normal limits.				Y					Y	11/09/2005	11/10/2005	1	Strep test within normal limits	UNK	UNK	NONE	NONE	NONE		SC0526	1						1	Arthralgia; Erythema; Insomnia; Pain; Paraesthesia; Pruritus; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U1819AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248834	12/06/2005	SC	78.0	77		F	12/06/2005	11/9/05 - tired, unable to work in garden.  Was able to walk and cook.  Did not feel like doing anything.  On 11/10/05 - eyes hurt and sensitive to light.  Did not see PMD or take Tylenol.  Public health nurse made referral to PMD if necessary.									Y	11/07/2005	11/09/2005	2	NONE	UNK	UNK	NONE	NONE	Arthritis - total knee replacement		SC0527	1						1	Eye pain; Fatigue; Photophobia	FLU3~SANOFI PASTEUR~U1823AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248835	12/06/2005	TX	58.0	58		M	12/06/2005	Fever developed within two hours of receiving flu shot on December 17, 2004.  Symptoms of flu continued, and treated by physician, hospitalization and diagnosis of Guillain Barre Syndrome made on January 8, 2005.   Has remained in hospitals until November 23, 2005 when released home with no function of daily activities.  Discharge summary for 1/8-2/6/2005. FINAL DX: presumed Guillain-Barre syndrome, respiratory failure requiring mechanical ventilation & quadriparesis; Pulmonary emboli; basilar atelectasis vs pneumonia by x-ray; hyponatremia secondary to SIADH; prerenal azotemia, resolved;  transient hematuria likely related to cathether, resolved; HTN; N/V, possibly Flagyl related; depression; recent diarrheal syndrome resolved.   Also states developed low-grade fever, dizziness, weakness & diarrheal illness following flu shot.  Seen in ER & d/c to home.  Had syncope & worsening s/s, returned to ER & admitted.  Eventually developed gen weakness, syncope & quadriparesis, intermittent confusion, apnea, hypertension/hypotension, dyasthenia.   During hospital stay developed quadreplegia, pulmonary empolism, bradicardia, hematuria, hyponatremia(114).  Areflexic.  ICU.  Neuro & nephro consults done.  Developed resp distress & was intubated.  Had non-ST change MI s/p hypotension/hypoxia.  Tx w/IVIG w/minimal improvement.  Developed bacteremia from lines & tx w/IV antibiotics.  Transferred to inpt rehab.			Y	Y	Y	30				12/17/2004	12/17/2004	0	Spinal Tap- showing hight levels of protein.  Medical record states LABS: MRI c-spine w/spondylosis & stenosis.  CSF: WBC 24(H), RBC 68(H), lymphs 24(L), protein 86(H), glucose 53(N), c/s neg.  CT angio (+) for PE.  Echocardiogram WNL.  CPK-MB & troponin (+).	MIL	MIL	Protonix, Lipitor	None	None known  Medical records states PMH: GERD, dyslipidemia, gout, sciatica, OSA, bilat inguinal hernia repair, TURP.  Allergy: sulfa.  Family hx: silicosis, COPD, dyslipidemia, CVA.			1						1	Apnoea; Asthenia; Bacterial infection; Bradycardia; Confusional state; Dehydration; Diarrhoea; Guillain-Barre syndrome; Haematuria; Hypertension; Hypotension; Pulmonary embolism; Pyrexia; Quadriplegia; Syncope	FLUX~UNKNOWN MANUFACTURER~U1505AA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0248837	12/06/2005	PA	33.0	32		F	12/06/2005	Immediately after injection of influenza vaccine on 11/17/05 patient felt pain at left deltoid site, went up arm toward neck. Patient reports bump at base of neck, left side on 11/18/05, 26 hrs after injection. Taking tylenol for pain, to see doctor 11/23/05									Y	11/17/2005	11/17/2005	0	seen by private physician 11/23/05, no treatment, reports that the lymph node enlargement may be related to the influenza injection	UNK	UNK		none	none			1						1	Lymphadenopathy; Pain; Skin nodule	FLU3~SANOFI PASTEUR~U1863AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248838	12/06/2005	NY	28.0	28		F	12/06/2005	By patient report:  Patient visited outside health facility due to upper arm cellulitis.  Received 24 hours of IV antibiotics followed with one week of PO antibiotic course.				Y	Y	2			Y	11/22/2005	11/23/2005	1	N/A	UNK	UNK	Levothyroxine	N/A	HX of Pneumonia x 2.  Hashimoto's disease.			1						1	Cellulitis; Injection site reaction	FLU3~SANOFI PASTEUR~U1869AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1047P~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0248839	12/06/2005	IL	76.0	76		F	12/06/2005	Client states 2 weeks after receiving the flu shot she had pain in her neck and couldn't turn it. She went to a chiropractor six times and felt a little better. About that time she also noticed her Lt arm feeling weak. Her Rt arm was okay. She saw a nurse practitioner and had elevated BP and was put on medication for this. She states her gait is unsteady and when she walks goes to her Lt. Flu shot was given on 10/4/05. She was seen in the emergency room on 12/2/05 and sent home on a med for arthritis. Today she states she is maybe a little better but still feels weak.				Y					N	10/04/2005	10/18/2005	14	12/2/05 EKG-normal; CT scan of head-normal Labwork done, client states was normal.	UNK	UNK	Zoloft	NONE	NONE			1						1	Gait disturbance; Muscular weakness; Neck pain	FLU3~SANOFI PASTEUR~U1803AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248841	12/06/2005	MD	28.0	28		F	12/05/2005	Facial and eye edema on 11/29/05.  She went to the ER.  Benadryl 2 tabs. and Zyrtec daily for 14 days.  No itching or shortness of breath.				Y					U	11/28/2005	11/28/2005	0	None.  Still on meds	UNK	UNK	none	no	none known			1						1	Eye oedema; Face oedema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62018~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB152DA~6~IM~RA~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0248844	12/06/2005	GA	45.0	45		F	12/06/2005	Upset stomach (very, very acid for the first day- no more).  Sore throat (still a little sore). General malaise (much better). Throat kept swelling even while taking Benadryl (still swollen but much better). Itching eyes and eyelids (no more). Itchy ears (inside) (no more). Rash like little blisters on forehead (gone now). Paled face (no more). Glassed eyes (no more). Nasal passages swelled (mostly gone). Tongue swelled (mostly gone). Inside of mouth swelled (gone). Wheezing (some). Hard time swallowing (mostly gone). Hard time breathing (mostly gone). Fever blister - secondary to acid stomach (gone).									Y	11/18/2005	11/24/2005	6	None.  Did not seek medical assistance until 12/7/05.	UNK	UNK	None	None	None			1						1	Blister; Dysphagia; Dyspnoea; Eye irritation; Herpes simplex; Malaise; Pallor; Pharyngolaryngeal pain; Rash; Staring; Stomach discomfort; Tongue oedema; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62013~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0248846	12/06/2005	FL	30.0	29		F	12/06/2005	Reported by client: Right arm pain and swelling at injection site(stated the size of a baseball).  6 hours later swelling in the right armpit with pain radiating to elbow.									N	12/05/2005	12/05/2005	0	None	UNK	UNK	Advair, Allegra, Singular, Topomax, Levapro, Zovia, Belladona, Nasonex, Ultram and Phenergan.	None reported.	Pre-existing diagnosed: asthma, seasonal allergies and migraine headaches.  Allergies: Immitrex, Tetracycline, Ceftin and Avalox.			1						1	Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1938AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248851	12/06/2005		1.0			M		A report was received from a healthcare professional regarding a 12 month old vaccinee. No details were provided regarding the vaccine's medical history or concomitant medication. On an unknown date the vaccinee received in Influenza vaccination, the vaccinee had also been vaccinated with the following on unknown dates, Varicella virus vaccine live, measles virus vaccine (Enders Edmonston), Mumps virus vaccine live (Jeryl Lynn), Rubella virus vaccine live (Wistar RA 24/3) and Pneumococcal vaccine. The vaccinee experienced a small amount of lesions on the body and fever elevated to 105 degrees F. The vaccinee was taken to hospital and was administered antibiotics. Laboratory studies were performed, but the results are unknown. The vaccinee recovered.					Y	0							Body temperature 105 F;Diagnostic and Laboratory tests result not provided.	UNK	UNK	Concomitant drugs not reported				CVOX200500216	1						1	Medication error; Pyrexia; Skin ulcer	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0248854	12/06/2005	CA	67.0	67		F		Difficulty breathing;weakness;fast heart beat;dizziness;hives and swelling.					Y	1			Y	11/11/2005				OTH	OTH	Ibuprofen 800 mg;Trimti HCTZ 75-50 mg;Doxepin HCL 50 mg					1						1	Asthenia; Dizziness; Dyspnoea; Heart rate increased; Swelling; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0248855	12/06/2005	NC	3.0	3		M	11/11/2005	Local reaction 7cm x 7cm erythema left deltoid non tender.									Y	11/09/2005	11/11/2005	2		PVT	PVT	Prevacid, Singulair, Motrin		Asthma		NC05107	1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U1823AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248857	12/06/2005	WI	0.85	0	.8	F	12/06/2005	Flu shot received 12/02 fever developed later on 12/02/2005 persisting through 12/05/2005.									U	12/02/2005	12/02/2005	0	NONE	PVT	OTH	NONE		Atopic Dermatitis			1						1	Pyrexia	FLU3~SANOFI PASTEUR~U1787EA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248858	12/06/2005	IL	58.0	57		F	12/06/2005	Shortly after receiving vaccine developed rash down left arm, light flushing in the face. the rash did cause itching. Pt took Benadryl and stated by the evening symptoms had subsided.									Y	12/05/2005	12/05/2005	0	NONE	OTH	PUB	NONE	Cold	Allergy, penicillin, hives			1						1	Flushing; Pruritus; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61129~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0248859	12/06/2005	IA	86.0	86		F	11/18/2005	Telephone call reported client had reaction to PN vaccine left deltoid region that affected it. Arm and side of body. Redness, rash and pain. Client seen DR 11/15/2005.										11/08/2005	11/18/2005	10	UNK	PUB	PVT						1						1	Injection site hypersensitivity; Pain; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61321~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0248860	12/06/2005	IA	63.0	63		F	11/18/2005	PN given in right gluteal and area red and sore shortly after given. Seen Dr 11/18/2005 and given cortisone injection, increased redness and swelling this am.										11/15/2005	11/18/2005	3		PUB	PVT		Had rotator cuff surgery wk before	Husband reports other med allergies.			1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61321~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0604R~UNK~IM~GM~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248861	12/06/2005	MD	71.0	70		F	11/29/2005	Flu shot at 7:30pm. severe diarrhea onset 7:30 am next morning. vomiting and fainting spell late that nite. Went to ER for IV and nausea medicine. Fever up to 102 was dehydrated but blood Chem was ok, low salts.				Y					Y	11/09/2005	11/10/2005	1	Blood chemistry ok except salts a little low.	UNK	PUB	Aciphex, vitamins, calcium					1						1	Blood sodium decreased; Dehydration; Diarrhoea; Pyrexia; Syncope; Vomiting	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0248862	12/06/2005	MD	27.0	27		M	11/10/2005	Patient seen in ER today c/o swelling of the left side of his face. Unable to lift my top lip on the left side. Also reports tenderness of the left sinus. No visual symptoms, no difficulty swallowing or breathing. Vital signs stable. Dx possible Bell's palsy. Rx with prednisone taper and Valtrex. Interested in VAERS form. Will contact tomorrow for intake information and follow up. Addendum 12/01/2005 spoke with pt 11/29/2005 and he said he was completely symptom free.				Y					U	10/24/2005	11/07/2005	14	NONE	MIL	MIL	Hydroxy OTC		Eczema			1						1	Face oedema; Facial palsy; Tenderness	FLU3~SANOFI PASTEUR~U1833BA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248863	12/06/2005	NC	51.0	51		F	11/30/2005	Guillain Barr Symptoms, no reflexes on right side, weakness, muscle aches, liver function test abnormal. Medical records state migraine, viral infection, rash, splenomegaly. msv									N	10/10/2005			CT scan, Blood work Medical records state lung disease, increased SGOT, SGPT, hypoproteionemia, abnormal lab tests. msv	OTH	PVT	Lisinopril, Inderal, Diltiazem, Fluoxetine, Midrin, aritus	NONE	Medical records state depression, migraine, neurosis. msv Medical records state tenosynovitis. msv			1						1	Alanine aminotransferase increased; Aspartate aminotransferase increased; Asthenia; Guillain-Barre syndrome; Hypoproteinaemia; Hyporeflexia; Laboratory test abnormal; Liver function test abnormal; Lung disorder; Migraine; Myalgia; Rash; Splenomegaly; Viral infection	FLU3~SANOFI PASTEUR~U1778AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248864	12/06/2005	OR	0.8	0	.8	M	11/28/2005	Fever up to 103.4 ax starting the evening vaccines were given. Lasted 6 days rash blotchy in axilla, neck, elbows and ankles also slight swelling of ankles for 5 days.									Y	10/26/2005	10/26/2005	0	NONE	PVT	UNK		Mild URI	NONE			1						1	Oedema; Pyrexia; Rash; Rash macular	FLU3~SANOFI PASTEUR~U1818AB~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SMITHKLINE BEECHAM~AHBVB092AA~UNK~~LL~HEP B (ENGERIX-B)~1|IPV~SANOFI PASTEUR~X05552~UNK~~RL~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0248865	12/06/2005	FL	51.0	51		F	11/30/2005	High fever and chills with hard shaking, trembling started 11/18/2005. Had all night. Next morning still had fever but chills subsided. However I started having a rapid heart beat which got as fast as 160 bpm. This lasted off and on all day scaring me. Tachycardia									Y	11/18/2005	11/18/2005	0	BP and heart rate were elevated. Took blood pressure, heart rate several times with home BP kit.	OTH	PVT		NONE				1						1	Blood pressure increased; Chills; Heart rate increased; Pyrexia; Tachycardia; Tremor	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0248866	12/06/2005	OH	52.0	52		M	11/14/2005	Patient first described feeling light headed within a couple minutes of vaccination. We had him sit down and he then began reporting nausea and dizziness as well. His blood pressure and pulse were fine, no SOB noted. Gave him orange juice and cake doughnut in case of low blood sugar issues. Took small amount of each. Pt and wife left to go to ER after about 30 minutes with no resolution in SX.				Y					Y	11/10/2005	11/10/2005	0		OTH	OTH	BP Meds per pt		High BP being treated.			1						1	Dizziness; Nausea	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248867	12/06/2005	AL	1.28	1	.3	F	11/30/2005	Patient was given 2 doses of influenza vaccine, one dose 0.25, one dose 0.5cc no adverse reaction.									Y	11/30/2005				PVT	PUB	NONE	NONE	Atopic dermatitis			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248869	12/06/2005	TX	16.0	16		M		10/09/2005 back to school after receiving shot developed severe headache, took 500mg Tylenol after school and again at HS. 10/10/2005 headache lessened went to school, headache continued, nasal congestion, felt bad, During night woke drenched with sweat, but no elevated temp. wrong sweat from sheets, pillowcase and PJ's. 10/11/2005 woke feeling ok and 10/12/2005 feeling normal.									Y	11/09/2005	11/09/2005	0		PUB	PUB	Ritalin, Tenex		Attention Deficit and hyperactive disorder, school sports PE 08/05 found slight heart murmur.			1						1	Headache; Hyperhidrosis; Malaise; Nasal congestion	FLU3~SANOFI PASTEUR~U1830AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0133R~1~IM~RA~HEP A (VAQTA)~1	USA		Influenza
0248870	12/06/2005	WI	51.0	50		F	12/02/2005	Became very restless, anxious, twisting and turning, could not settle down. Was cold, Generalized weakness, Headache, Next day, loss of balance. symptom's lasted until 12/01/2005. Symptoms developed all at once approx 4 hours after vaccination. Encouraged to discuss with PMD.									Y	11/29/2005	11/29/2005	0	NONE	OTH	OTH	Clonazepam, Zoloft		Social anxiety disorder, Migraines.			1						1	Abnormal behaviour; Anxiety; Asthenia; Balance disorder; Feeling cold; Headache; Restlessness	FLU3~SANOFI PASTEUR~U1881AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248871	12/06/2005	WA	34.0	34		F	11/01/2005	Soreness and stiffness in neck and arm on right side (same as inj site). Achiness in upper body. No meds or Tx									Y	10/28/2005	10/28/2005	0	NONE	PUB	PVT	NONE	NONE	NONE			1						1	Injection site reaction; Musculoskeletal stiffness; Myalgia; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA151BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0248872	12/06/2005	WA	51.0	50		F	11/01/2005	Extreme fatigue and achiness plus chills. Denies fever. S/S lasted until 10/29/05 at 12:00. Took Tylenol (1gm) time one.									Y	10/28/2005	10/28/2005	0		PUB	PVT	NONE	NONE	NONE			1						1	Chills; Fatigue; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA151BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0248873	12/06/2005	WA	29.0	28		F	11/01/2005	Neck and arm stiffness that lasted 24 hours. Took Advil for discomfort									Y	10/28/2005	10/28/2005	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Musculoskeletal stiffness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA151BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0248875	12/06/2005	WA	58.0	57		F	11/28/2005	Red, swelling at inj site Tennis Ball plus itching and fever. States she took Tylenol off and on x's one week until red/purple lump was gone.									Y	10/28/2005	10/28/2005	0		PUB	PVT	Tylenol PRN	NONE	Seasonal Allergies - Physician diagnosed	allergy inj 2/05 serum antigen~Vaccine not specified (no brand name)~~0.00~In Patient		1						1	Hypersensitivity; Injection site erythema; Injection site reaction; Injection site swelling; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~U1864AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248876	12/06/2005	SC	59.0	58		F	12/01/2005	Received flu vaccine 8:55 am 11/29/05 began breaking out with red rash on neck down  upper chest with itching and burning on 8:00 pm 11/30/05.									Y	11/29/2005	11/30/2005	1	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Erythema; Pruritus; Rash; Skin burning sensation	FLU3~SANOFI PASTEUR~U1824AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248878	12/06/2005	TN	80.0	80		F	11/17/2005	Flu and pneumonia vaccine give in same syringe. Currently in process of re-vaccinating per CDC.										10/22/2005				OTH	PUB		ESRD	UNK			1						1	Medication error	FLU3~SANOFI PASTEUR~U1763AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248879	12/06/2005	MN	33.0	32		F	12/02/2005	Pt developed severe pain on left where vaccine was administrated. Hard to move shoulder and lost sleep over pain. Took Vicodin to alleviate pain. Saw PCP who did an MRI that showed the vaccine was administered to high, hitting the tendon and causing tendonitis and bursitis. Pain improving at this point.				Y					Y	11/17/2005	11/18/2005	1	MRI- showed damage to tendon for shot and bursitis	PVT	PVT	Wellbutrin;Robitussin-AC	NONE	Allergies to sulfa drugs;Compazine. No medical problems			1						1	Bursitis; Hypokinesia; Incorrect route of drug administration; Pain; Sleep disorder; Tendonitis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA141BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0248880	12/06/2005		57.0	57		F	11/22/2005	1. Redness at site of injection at 48 hours post vaccine and 3 cm diameter in size. 2. Rash on forearms ?? urticarial at 24 hours post vaccine. Already had cleared by 48 hours. 3. Felt shaking.									N	11/17/2005	11/19/2005	2	NONE	MIL	MIL		T/x of	Seizure disorder; Hyperlipidemia			1						1	Injection site erythema; Rash; Tremor	FLU3~SANOFI PASTEUR~U1930AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248881	12/06/2005	IA	55.0	55		F	11/27/2005	Patient developed following Sxs approximately 5 1/2 hours after receiving flu vaccine - sore throat, runny stuffy nose, aches, pains and exhaustion. Went to bed, slept for 12 hrs and felt fine when she woke up.									Y	11/18/2005	11/18/2005	0	NONE	OTH	OTH	UNK	NONE	UNK			1						1	Fatigue; Nasal congestion; Pain; Pharyngolaryngeal pain; Rhinorrhoea; Somnolence	FLU3~SANOFI PASTEUR~U1830AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248882	12/06/2005	IA	43.0	42		F	11/21/2005	Later in the evening was in hot tub and noticed rash on abdomen. Got out and rash continue to spread to arms, chest and neck. Have used hot tub many times before - no problems. Called physician next day - recommended Benadryl- hydrocortisone  cream.				Y					Y	11/15/2005	11/15/2005	0	NONE	OTH	UNK	BCP	NONE	NONE			1						1	Rash	FLU3~SANOFI PASTEUR~U1794AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248883	12/06/2005	IA	40.0	39		F	11/14/2005	About 3:30 pm - Began feeling weak, tired, nauseous. Approx one hour later, skin began feeling tingling and itchy. By 7:30 pm temperature was 101 degrees F, skin was red and very itchy/tingling. Skin continued to be bothered beyond 24 hours. Temp at 8:00 am 11/15 was 99 degrees F.									Y	11/08/2005	11/08/2005	0	NONE	OTH	UNK	NONE	NONE	NONE			1						1	Asthenia; Erythema; Fatigue; Nausea; Paraesthesia; Pruritus; Pyrexia; Skin disorder	FLU3~SANOFI PASTEUR~U1830AA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248884	12/06/2005	TX	8.0	8		M	12/01/2005	Vaccine at 8 am approx 11:00 am hives - at pm 8:30/9:00 pm running fever increase itching. Next am - started vomiting, fever progressing all day. Gave Benadryl/Tylenol/Motrin next morning. Total illness lasted about 3 days.									Y	11/15/2005	11/15/2005	0		OTH	PUB	NONE	NONE	Heart murmur			1						1	Pruritus; Pyrexia; Urticaria; Vomiting	FLU3~SANOFI PASTEUR~U1817AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248885	12/06/2005	PA	13.0	12		M	12/02/2005	Seizure generalized tonic clonic lasting about 30 sec. Resolved spontaneously. Evaluation normal after event.				Y					Y	11/29/2005	11/30/2005	1	Head CT scan;CBC;Lytes;BUN;CR-normal	PVT	PVT		NONE	Down Syndrome, Allergic Rhinitis;S/P repair; AV canal defect mitral valve			1						1	Convulsion	FLU3~SANOFI PASTEUR~U1850AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1877AA~UNK~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0248886	12/06/2005	MI	42.0	41		M	11/28/2005	Telephone call from pt. 11/25/05 states he had swelling in axilla right and red welts on right shoulder. Beginning 1 hour after vaccination. He began taking Benadryl. Had some fatigue several days, 11/2//05 wife state at work feeling better.									Y	11/22/2005	11/22/2005	0	NONE	OTH	PVT		NONE	NONE			1						1	Erythema; Fatigue; Swelling; Urticaria	FLU3~SANOFI PASTEUR~U1872AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1047P~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248888	12/06/2005	IA	88.0	87		F	11/08/2005	Client reports the same day arm had egg sized red area with pain and swelling. Called DR office again and found she just had it in April and this is why she reacted she said she forgot she had it.									Y	10/31/2005	10/31/2005	0	NONE	PUB	PVT	Calcium;ASA;Nexapril taken that am	NONE	Once had a cellulitis after injury		JA05017	1						1	Erythema; Pain; Swelling	FLU3~SANOFI PASTEUR~V1903AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248850	12/07/2005		49.0	49		M	12/07/2005	ATYPICAL PNEUMONIA, MICROPLASMA IN UPPER HALF OF RIGHT LUNG.			Y	Y	Y	5			Y	02/07/2003	02/08/2003	1	X-RAY SHOWING PNEUMONIA IN RIGHT UPPER HALF OF LUNG MICROPLASMS, LIVER ENZYMES ABNORMAL. Added from Discharge Summary rec'd 12/14/2005: Blurred vision, dizzy, flu symptoms, SOB, ear pain/sr	MIL	MIL	NONE	NONE	NONE			1						1	Cough; Dizziness; Dyspnoea; Ear pain; Headache; Hepatic enzyme abnormal; Influenza; Pneumonia; Toothache; Vision blurred	ANTH~EMERGENT BIOSOLUTIONS~FAV064~1~ID~RA~ANTHRAX (BIOTHRAX)~1|FLU3~PFIZER\WYETH~9870303~1~IM~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|MEN~SANOFI PASTEUR~CIB243AA~1~ID~LA~MENINGOCOCCAL (MENOMUNE)~1|SMALL~PFIZER\WYETH~4020071~1~ID~RA~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~C10705~1~ID~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Life Threatening,Hospitalisation	Influenza
0248856	12/07/2005	CA	32.0	31		F	12/06/2005	Patient vaccinated on 12/2/05 and complained of vomiting, headache and 103 fever for 2 days approximately 27 hours status post vaccination.									Y	12/02/2005	12/03/2005	1	NONE	PVT	PVT	Dayquil	Headache; Upset Stomach; Sinus problems; Tired.	PCN			1						1	Headache; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1868AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~AVENTIS PASTEUR~C2384AA~UNK~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0248910	12/07/2005	OH	3.0	2	.7	F	12/07/2005	Large local reaction to left thigh and no systemic signs all within 24 hours of vaccine.									Y	12/02/2005	12/03/2005	1	NONE	MIL	MIL	NONE	NONE	NONE			1						1	Injection site reaction	FLU3~SANOFI PASTEUR~U1916AA~4~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248911	12/07/2005	WI	42.0	41		F	11/30/2005	My arm hurt immediately. By Sunday morning, I went to emergency room. I had severe pain down my entire right arm from the shoulder. I couldn't sleep because of the pain. It still hurts.				Y					N	11/04/2005	11/04/2005	0	Nerve damage in right arm.	OTH	PVT		NONE	Allergies to amoxicillin, vibromycin; hypoglycemic.			1						1	Nerve injury; Pain; Sleep disorder	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61323~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0248912	12/07/2005	TX	0.84	0	.8	M	11/28/2005	Developed rash on face/body. Seen in ER. Physical examination - urticarial rash. Rx: Benadryl 6.25mg PO, Prednisone 18mg PO. Decreased erythema.				Y					Y	10/31/2005	10/31/2005	0	NONE	PVT	PUB	NONE	NONE	NONE		TX05102	1						1	Erythema; Rash; Urticaria	FLU3~SANOFI PASTEUR~U1743HA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248913	12/07/2005	TX	11.0	10		F	11/21/2005	Hives - treated with Benadryl.									Y	11/17/2005	11/17/2005	0		PVT	PVT	Singulair; Albuterol; Flonase; Advair; Auralgon	Otalgia; Allergic Rhinitis; Asthma	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1814AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248914	12/07/2005	OR	6.0	5		F	11/15/2005	11/15 Mom reports that child received flu shot at approximately 3:00 PM. At 7:00 PM, she began vomiting, no dinner. Restless in the NOC, temp 104. Mom gave Gatorade in NOC. Next AM, eating little, no emesis. Questionable temp. To PCP. No problems identified (Wed). Thurs, no fever, no emesis, eating and returned to school. More quiet than usual. By Thursday evening, ate good dinner and slept well. Yesterday (11/14) temp again increased to 105, poor appetite and lethargy. Better today. Kept home from school 11/15/05.									Y	11/08/2005	11/08/2005	0	NONE	PUB	PUB	NONE		Downs Syndrome		OR200542	1						1	Lethargy; Oral intake reduced; Pyrexia; Restlessness; Vomiting	FLU3~SANOFI PASTEUR~U1868AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248915	12/07/2005	OR	52.0	52		F	11/08/2005	Telephone call to clinic 11/8. Client states at 11:00 PM she experienced nausea and difficulty breathing. Complained of feeling achy all over. Awake off and on all NOC. In AM, continued to complain of achiness; had trouble getting going. Stayed home from work. Had also complained of abdominal pain and syncope in the NOC. Abdominal pain relieved after stool. Had increased pulse at 112/min and decreased BP at 88/58. Had taken a dose of Trazadone at HS (Med is not new). Eating/Drinking FLDS. 11/10/05 Telephone call follow up states felt ok. 11/9 returned to work. Complained of light soreness at injection site. Did not go to doctor. No history of previous injection reactions. Continued to be fine today. Client states I wonder if the Trazadone made me feel this way.									Y	11/07/2005	11/07/2005	0	NONE	PUB	PVT	Trazadone	NONE	NONE		OR200541	1						1	Abdominal pain; Blood pressure decreased; Dyspnoea; Heart rate increased; Injection site pain; Nausea; Pain; Syncope	FLU3~SANOFI PASTEUR~U1868AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248917	12/07/2005	OH	50.0	49		F	12/01/2005	Pt called to report burning in both eyes and scratchy throat several hours after influenza vaccine administered.  Denies tightness in throat or chest or difficulty breathing.  Has taken vaccine in past with no problems.  Relieved with PO Benadryl within 24hrs.									Y	12/01/2005	12/01/2005	0		PVT	UNK						1						1	Dry throat; Eye irritation	FLU3~SANOFI PASTEUR~U1911AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248918	12/07/2005	MD	73.0			F	11/30/2005	Bright red at injection site.  Swollen and sore for over two weeks.  Felt strange.  Sensitive to air inside and outside-burning.  Ensuing days awaken to inability to open eyes.  Cranial pressure, aching joints.														PUB	OTH	Ogen, Provera, gastrocrom vitas, some supplements		allergies-dust mite, mold, dust			1						1	Arthralgia; Eye disorder; Headache; Injection site erythema; Skin burning sensation; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0248929	12/07/2005	MN	12.0	11		M	12/07/2005	Fluarix vaccine given to patient under the age of 18.  Lot # afluaa147 exp 8/4/06.									Y	11/05/2005	11/05/2005	0		UNK	UNK	no	no	no			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~afluaa147~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0248930	12/07/2005	VA	39.0	38		M	12/07/2005	C/O severe dizziness and dry throat 30 minutes after receiving immunization.  Benadryl 50mg IM/EKG.									Y	12/07/2005	12/07/2005	0	n/a	MIL	MIL	n/a	n/a	n/a			1						1	Dizziness; Dry throat	FLU3~SANOFI PASTEUR~U1935AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248934	12/07/2005	AL	0.51	0	.5	F	12/07/2005	LOW-GRADE FEVER, REDNESS/SWELLING AT INJECTION SITE, FUSSINESS IN CHILD WITH NON-STOP CRYING EPISODES LASTING OVER THREE HOURS.  THIS OCCURRED EARLY IN MORNING FOLLOWING IMMUNIZATIONS. REPORTED TO OFFICE 12/7/05 ORAPRED AND BENADRYL ORDERED.									N	12/06/2005	12/07/2005	1		UNK	UNK						1						1	Crying; Injection site erythema; Injection site swelling; Irritability; Pyrexia	DTAPH~SANOFI PASTEUR~U1387BB/UE653AA~3~SC~LL~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~U1788AA~1~SC~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~PASTEUR MERIEUX CONNAUGHT~Y0343~3~SC~RL~POLIO VIRUS, INACT. (NO BRAND NAME)~1|PNC~PFIZER\WYETH~A94451C~3~SC~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0248935	12/07/2005	MI	37.0	37		F	12/07/2005	Patient c/o swelling to left deltoid with pain and discomfort. Local edema noted on left deltoid.									Y	12/03/2005	12/03/2005	0		MIL	MIL	NA	NA	NKDA			1						1	Discomfort; Pain; Swelling	FLU3~SANOFI PASTEUR~U1869AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U1616DA~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0248940	12/07/2005	NY	0.87	0	.9	M	12/07/2005	POST 10 MINUTES OF RECIEVING INFLUENZA VACCINE. PATIENT DEVELOPED RASH ON TRUNK OF BODY. M.D ADMINISTERED 3/4 TSP. OF BENADRYL BY MOUTH. CHILD WAS DISCHARGE IN NO APPARENT DISTRESS. SMILING, ACTIVE, CONSCIOUS.									Y	12/06/2005	12/06/2005	0	NONE	UNK	UNK	NONE	WELL BABY WITH MILD CASE OF BRONCHIOLITIS.	NONE			1						1	Rash	FLU3~SANOFI PASTEUR~U1788GA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248942	12/07/2005	CA	4.0	3		M	12/07/2005	On 11/08/05,Mother of patient called to say patient has rectal temperature of 104.8 (had flu vaccine on 11/07/05). 11/09/05, ear temperature of 101.3.  11/10/05, ear temperature of 103.9. Mom writes on notes about those days, her son has a horrible cough, vomiting, no appetite.  Patient was taken to see a physician on 11/10/05, where he had temp of 99.9, was diagnosed with viral syndrome. Mom says later that Dr. said the fever was not related to the flu vaccine. On progress notes from the Dr. visit, cough, congestion, nasal discharge, vomiting, constipation, fever, no appetite were listed as presenting symptoms.  Treatment recommended as follows: ibuprofen alternating as needed with tylenol, fluids, rest.				Y					Y	11/07/2005	11/08/2005	1	Just thermometer reading	UNK	UNK	TYLENOL	Had mild upper respiratory illness 1 month prior to vaccination	Asthma, Anemia			1						1	Anorexia; Constipation; Cough; Nasal congestion; Pyrexia; Rhinorrhoea; Viral infection; Vomiting	FLU3~SANOFI PASTEUR~U1770AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248944	12/07/2005	OH	22.0	21		F	12/07/2005	Anaphylactic reaction, chest tightness, SOB, spO2 dropped to 64 %. 0.3 mg epinephrine and 25 mg Benadryl given. Onset of symptoms occurred approx 5 minutes post injection of Fluzone. 911 was called Pt was transported to hospital for observation.			Y	Y					Y	12/05/2005	12/05/2005	0		PUB	PUB	Zantac, Trileptal, Naprosyn, Albuterol, Zelnorm	Anaphylactic Reaction	Asthma, Seizures, Anxiety			1						1	Anaphylactic reaction; Chest discomfort; Dyspnoea; Hypoxia	FLU3~SANOFI PASTEUR~U1872AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0248947	12/07/2005	MI	42.0	42		F		30 minutes after injection, hives developed at injection site. Developed flushing and hives across chest, throat closing, wheezing. Pt is being worked up for possible carcinoma due to ongoing, repeated espiodes of the anaphylactic reaction.\ Medical records state urticaria, dyspnea. msv				Y	Y				Y	12/01/2005	12/01/2005	0	CBC X 2;BMP	UNK	UNK	Oral Conception	NONE	NONE Medical records state allergy, hypoglycemia. msv			1						1	Dyspnoea; Flushing; Injection site reaction; Throat tightness; Urticaria; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62217~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0248948	12/07/2005	PA	45.0	45		F	12/07/2005	12/2 Awoke in AM with inability to smile and close right eyelid. Went to ER and diagnosed with Bell's Palsy. Rx with Acyclovir and Prednisone. Lyme titer done - no results yet. CT scan of head negative.				Y					U	10/11/2005	12/02/2005	52	CT Scan Head WNL; Lyme titer done 12/2/05 - no results available.	PVT	OTH		NONE	NKDA; NKLA; NKFA; Migraines; Sinusitis; Herniated disc.			1						1	Eyelid retraction; Facial palsy; Hypokinesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA154BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0248949	12/07/2005	FL	42.0	42		F	12/07/2005	10:05 Patient given 0.5cc Fluarix flu vaccine IM left deltoid without incident. 10:20 Complaints of rash and pruritus upper chest, neck and facial area; face flushed. Given Benadryl 25mg PO 2 times and reported to doctor. Advised contact personal MD or present to clinic for Solumedrol PRX. 12/1 No rash/pruritus reported.									Y	11/30/2005	11/30/2005	0	NONE	OTH	OTH	Multivitamins; Tylenol PM	NONE	NONE			1						1	Flushing; Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA151AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0248950	12/07/2005	KS	1.05	1	.0	F	12/07/2005	Redness and welt at site of MMR immediately after injection. Resolved with in 20 minutes with no other symptoms.									Y	12/05/2005	12/05/2005	0		PVT	PVT		NONE	NONE			1						1	Injection site hypersensitivity; Injection site reaction; Urticaria	DTAP~SMITHKLINE BEECHAM~AC14A006CA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1743AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE777AA~4~IM~LL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0240R~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08636D~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0784R~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0248951	12/07/2005	MI	38.0	37		F	12/06/2005	Received Hep B and Flu for first time. Approx 20 minutes after, started itching on torso. Arrived home later pm discovered numerous hives, torso, back, legs, arms. No fever, no resp distress, no local reactions. Called health access took Benadryl, SXS relieved but have reappeared. Continues with Benadryl. Contact DR for advice direction for future IMS.									Y	12/05/2005	12/05/2005	0		PUB	PVT	Digoxin, Foslmax		Heart arrhythmia, osteoporosis, environmental food allergies, denies egg or yeast allergy.			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1747AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0687R~1~IM~RA~HEP B (RECOMBIVAX HB)~1	USA		Influenza
0247295	12/08/2005	MD	48.0	48		F	12/08/2005	At 3 hours after vaccination, patient felt swelling in throat (no itching, difficulty breathing), noticed eyes puffy; went to clinic and given Zantac. Symptoms resolved 1 hour later.				Y					Y	11/11/2005	11/11/2005	0	NONE	OTH	PVT	Calcium; Vitamin D; Zoloft	NONE	Sulfa; Demerol; Toluene			1						2	Cough; Dysphagia; Eye discharge; Headache; Lethargy; Ocular hyperaemia; Throat tightness; Pharyngeal oedema; Eye swelling; Pharyngeal oedema	FLUX~UNKNOWN MANUFACTURER~~3~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1863AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~U1863AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Emergency room visit	Influenza
0248538	12/08/2005	PA	1.07	1	.1	M	11/30/2005	Fever lethargy questionable duration. Sleeps in same bed as mother (a 16 year old), who on 11/26/2005 at 5:00 am noted funny breathing, then found infant unresponsive - EMS also unresponsive. Resus at hospital (see attached form).	Y	11/24/2005							N	11/22/2005	11/24/2005	2		PUB	PUB						1						2	Apnoea; Malaise; Upper respiratory tract infection; Abnormal sleep-related event; Coma; Lethargy; Pyrexia; Respiratory disorder	FLU3~SANOFI PASTEUR~U1787DA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1072P~1~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0418R~1~~~VARICELLA (VARIVAX)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~SANOFI PASTEUR~~UNK~~~HIB (ACTHIB)~2|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~2|VARCEL~MERCK & CO. INC.~~UNK~~~VARICELLA (VARIVAX)~2	USA	Results in Death	Influenza
0248969	12/08/2005	FL	5.0	4		F	11/30/2005	Patients arm was red, swollen, hot 2 days after shots were given right arm.				Y						11/21/2005	11/23/2005	2	Severe Cellulitis	PVT	PVT		NONE				1						1	Cellulitis; Erythema; Feeling hot; Oedema	DTAP~SMITHKLINE BEECHAM~AC14A009BA~5~~RA~DTAP (INFANRIX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61503~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~Y0459~4~~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0239R~2~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0248971	12/08/2005	MN	14.0	14		F	12/02/2005	Arthus reactions, (redness, swelling, plus wheezing and lymphadenitis with intermittent chest pain.									Y	11/21/2005	11/22/2005	1	Chest X ray, Albuterol and pulse and taper of steroids.	PVT	PVT	Nasonex, Protopic, Zyrtec, Singular, Prednisone	NONE				1						1	Chest pain; Injection site hypersensitivity; Injection site oedema; Lymphadenitis; Type III immune complex mediated reaction; Wheezing	FLU3~SANOFI PASTEUR~U1915AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1004P~1~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248972	12/08/2005	FL	5.0	4		F	11/30/2005	Patients left arm was red, slightly swollen, hot 2 days after shots were given left arm.				Y					Y	11/21/2005	11/23/2005	2	Mild Cellulitis	PVT	PVT		NONE				1						1	Cellulitis; Erythema; Oedema	DTAP~SMITHKLINE BEECHAM~Ac14A0098A~5~~RA~DTAP (INFANRIX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61503~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~Y0459~4~~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0239R~2~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0248973	12/08/2005	WA	11.0	11		M	12/02/2005	Pt developed hives about 5 hours after vaccinations, improved with Benadryl.				Y					Y	11/30/2005	11/30/2005	0	NONE	PVT	UNK	Hydrocortisone cream	NONE	Fibrodysplasia of tibia, Eczema			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1865AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1809AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0248974	12/08/2005	WI	0.53	0	.5	F	12/05/2005	Fever and rash.				Y					Y	12/01/2005	12/02/2005	1		PVT	PVT						1						1	Pyrexia; Rash	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B034AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1830AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A85856E~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0248975	12/08/2005	MN	1.26	1	.3	M	11/23/2005	Pt here for 15 month check and well at time. Rash began 11/17/2005  on face, by noon rash head, neck, tummy. Seen and diagnoses as varicella at 6pm 11/17/2005. Fever to 104 on 11/22. No known exposure to disease. Pt was ill for 10 days with fever for 7 days.									Y	11/08/2005	11/17/2005	9	NONE	PVT	PVT		Well child.				1						1	Malaise; Pyrexia; Rash; Viral infection	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B002BA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1743MA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A858~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0393R~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0248992	12/08/2005	TX	1.04	1	.0	M	12/08/2005	Rash, hives to face then spread to torso.				Y					U	12/06/2005	12/06/2005	0		PVT	PVT	PPD skin test, Tylenol	NONE	NONE			1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~U1905AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0291R~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0324R~1~~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0248993	12/08/2005	SC	46.0	46		F	12/08/2005	Awoke 11/05/05 am with numbness and tingling (gradual onset over 1 week time period) from waist down and in both hands.  Went to MD at Doctor's Care on 11/12.  On 11/13: unable to walk; went to Urgent Care and was scheduled for MRI and sent home.  On 11/13 pm - more difficulty walking - went to ER - X-ray and referral to neurologist.  On 11/14: saw family MD and was admitted to Hospital.  Spinal tap and multiple MRIs done.  Neurologist's diagnosis was Guillian Barre' Syndrome Medical records state urinary tract infection, pain.  Utilized brace (leg) and cane to assist with ambulation.				Y	Y	8			N	10/31/2005	11/05/2005	5	Multiple MRIs - normal; Chest x-ray normal; Spinal tap showed high protein level; bloodwork normal; diagnosis was Guillian Barre' Syndrome Discharge summary states csf abnormal, GBS disproved.	UNK	UNK	Lisimpril; Wellbutrin 150 mg (began on 11/3); Clonidine	Coughing - no fever	Hypertension; Depression		SC0528	1						1	CSF test abnormal; Difficulty in walking; Guillain-Barre syndrome; Hypoaesthesia; Laboratory test abnormal; Pain; Urinary tract infection	FLU3~SANOFI PASTEUR~U1903AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0248995	12/08/2005	OH	1.03	1	.0	M	12/08/2005	Patient received the Prevnar vaccine, Comvax vaccine, Varivax vaccine, and athe Fluzone vaccine on 11-29-05 around 9 am.  Patient's mother called at 138 pm to report that the patient was very fussy, acting like his entire body was in pain especially the leg area.  She was advised to give a dose of Tylenol and call back in 45 minutes if there was no improvement. The patient's mother called back at 405pm to report that he had fallen asleep after the tylenol but when he woke up he is crying when any pressure is applied to the legs and was refusing to stand or walk on it, the patient's mother was advised to bring the child back in to the doctor's office to be re evaluated.  Mother returned with the patient at 7pm and was seen MD the patient's legs were found to have small red puncture marks but no swelling and the patient was doing beter by the time of the visit.				Y					Y	11/29/2005	11/29/2005	0	none	UNK	UNK	none	none reported	none listed			1						1	Erythema; Hypokinesia; Irritability; Pain	FLU3~SANOFI PASTEUR~u1850aa~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0695r~2~IM~LL~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~bo8637e~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0788r~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0248996	12/08/2005	SC	58.0	58		F	12/08/2005	Client complained of a skin burning feeling that is constant since time of the injection.  He says burning is from his upper arm at immunization site down to the inside of wrist.  Client denies any loss of function and has not taken any medicine for this complaint.  During the past 23 days he says pain is no better and no worse, just the same.									N	11/09/2005	11/09/2005	0	NONE	UNK	UNK	Blood pressure prescription; Nasonex	NONE	Heart attack about 12 years ago, hypertension, seasonal allergies		SC0529	1						1	Pain; Skin burning sensation	FLU3~SANOFI PASTEUR~U1914AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0248997	12/08/2005	CT	45.0	44		M	12/08/2005	Pt reports started with chest congestion 11/28, sweating at night but not sure if any fever. Complained of R arm being swollen but unable to say when swelling started. Saw MD 11/30. Pt states the MD saidyour immune system is too good. He was treated with Symmetrel 100 mg and hydrocodone/ap				Y					Y	11/19/2005	11/28/2005	9		UNK	UNK		NONE	NONE			1						1	Hyperhidrosis; Oedema; Pulmonary congestion	FLU3~SANOFI PASTEUR~U1945AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0248998	12/08/2005	MS	67.0	66		F	12/02/2005	7-8 CM AREA OF REDNESS, HEAT AND SWELLING APPROX 1 INCH BELOW LOWER INJECTION SITE ON L UPPER ARM AND SECOND S/P MASTECTOMY R SIDE.  C/O MUSCLE ACHE, SORENSS @ REDDEN AREA. DEVELOPED CHILLS, BODY ACHES AND JUST DIDN'T FEEL WELL DAY AFTER IMMUNIZATION LASTING 11/29/2005-12/01/2005. REDDEN L ARM PRESENT TO ELBOW.									Y	11/29/2005	11/29/2005	0	NONE	UNK	UNK	AVISTA AND VITAMINS DAILY	NONE	RIGHT MYSTECTOMY IN 1995		MS0523	1						1	Chills; Injection site erythema; Injection site oedema; Injection site warmth; Myalgia	FLU3~SANOFI PASTEUR~U1915AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~104OP~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249000	12/08/2005	NJ	69.0	69		M	12/08/2005	Approximately four hours after administration of flu vaccine (and concurrent pneumococcal vaccine), patient felt flu symptoms.  Within 2-3 hours, full case of flu developed with chills/fever, full-body muscle aching, eye irritation, dry cough, headache, fatigue.  Patient spent next 36 hours in bed.  Fever broke after appox. 30 hours.  Dry cough persists into fourth day after vaccination.  Treatment was bed rest, aspirin, OTC cough suppressant.  Patient is not illness-prone, has not had flu for more than five years prior.  Patient in generally strong health, except for Type II diabetes, which is well controlled by diet, medication, and exercise.  No adverse reaction with any prior influenza vaccination.									Y	12/05/2005	12/05/2005	0	None	UNK	UNK	Metformin, Glipizide	None	Type II diabetes			1						1	Chills; Cough; Eye irritation; Fatigue; Headache; Influenza; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~7+~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0249003	12/08/2005	KS	90.0	89		F	12/08/2005	PT REPORTED DISCOMFORT OF LUE AND RN NOTED REDNESS AND MINIMAL SWELLING APPROX. 6x3 BEGINNING APPROX. 1 BELOW INJECTION SITE AND EXTENDING TOWARDS ELBOW AND AROUND ARM POSTERIORLY.  ICE PACK WAS APPLIED TO SITE.									N	12/04/2005	12/07/2005	3		UNK	UNK		NON-ACUTE PNEUMONIA	NO KNOWN ALLERGIES, H/O ALZHEIMER'S DEMENTIA, CHF, AND DEPRESSION			1						1	Discomfort; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U1917AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0974P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249005	12/08/2005	WA	52.0	52		M	12/08/2005	The patient received his flu vaccine injection in the upper left deltoid muscle between 10AM and 11AM on 11/6/05.  At the time of immunization he did not complain of pain.  Later that day he experienced sharp pain in the injection area when lifting it and has had continued pain since that time associated with lifting of the arm or going through a range of motion (eg., when applying deoderant he can only lift his arm to about 90 degrees-- he cannot lift his arm any further without pain.  He does not experience pain upon touching or pressing his arm, only upon lifting or moving in a range of motion. He has not seen a physician at this point (12/8/2005).									N	11/06/2005	11/06/2005	0		UNK	UNK	Unknown	None	Iodine			1						1	Injection site pain; Joint range of motion decreased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA151AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249010	12/08/2005	IN	0.52	0	.5	M	12/08/2005	Baby developed rash almost immediately after receiving immunizations. Parents also reported baby acting tired and sleepy. Child's pediatrician notified 12/08/2005 rash gone, baby has low grade fever 100.									Y	12/07/2005	12/07/2005	0		PUB	PUB			Baby has slight asymptomatic rash after 4 month			1						1	Fatigue; Pyrexia; Rash; Somnolence	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B015DA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~19114AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0620R~3~IM~LL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~AS6077C~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0249011	12/08/2005	CA	26.0	26		F	12/08/2005	10/25/05 abdominal cramps since she had taken 1st oral typhoid 3 hours eariler. Pt also described nausea and vomiting. Oral typhoid stopped - symptoms resolved.									Y	10/24/2005	10/25/2005	1		PUB	PUB						1						1	Abdominal pain; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U1745AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB036AA~1~IM~RA~HEP A + HEP B (TWINRIX)~1|TD~AVENTIS PASTEUR~U1187AA~4~IM~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1|TYP~BERNA BIOTECH, LTD.~3000902~1~PO~MO~TYPHOID LIVE ORAL TY21A (VIVOTIF)~1	USA		Influenza
0249016	12/08/2005	WA	63.0	62		F	12/08/2005	Pt developed a lot of soreness and swelling at injection site a few days after. She states it has decr but there is still a nodule (golf ball sized) at injection site over 3 weeks after.									N	11/13/2005	11/15/2005	2		OTH	OTH						1						1	Injection site nodule; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U1818AB~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249083	12/08/2005	MN	54.0	54		F	12/09/2005	10 hours after vax severe vomiting, diarrhea, myalgia and fever									Y	12/08/2005	12/08/2005	0		PVT	UNK	vitamine, sulfa, estrogen, progest					1						1	Diarrhoea; Myalgia; Pyrexia; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62938~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0246977	12/09/2005	MN	68.0	68		F	12/06/2005	Initial report received from another manufacturer (who received information from a health care provider, report number WAES0510USA07895, on Nov 23 2005. A 68 year old female patient received a left deltoid injection of Fluzone SV 2005-2005. lot number U1811AA, on Oct 13 2005. On the same day, the patient received a subcutaneous right arm injection of Pneumovax 23,, lot number 650452/0753P. During the night on Oct 13 2005, she experienced chills and developed pain, swelling, redness and warmth of the right upper arm (not the site of Fluzone administration). There was no other known injury, fever or related symptoms of concern. On Oct 14 2005, she presented to the physicians office and upon examination, was found to have 2/4+ edema, erythema, tenderness and warmth of the posterolateral right upper arm. There was no other external evidence of injury or inflammation and no lymphangitis or local adenopathy. The local reaction at the injection site was diagnosed as cellulitis that effected the entire right upper arm and was probably secondary to the Pneumo 23 vaccine. She was given acetaminophen for fever control and cephalexin 500 mg PO TID for ten days. On Oct 15 2005, she was re examined in her physicians office as her right upper arm continued to be red, swollen and slightly tender. She had normal range of motion of joints and normal neurovascular assessment of the right arm and no lymphangitis. Home health care was required for intravenous administration of Rocephin 2 grams on Oct 15 2005 and daily for two additional days. On Oct 16 2005, she was re examined. The warmth and redness of the right arm were about the same, and pain had decreased. On Oct 17 2005, there was decrease in the swelling, redness and tenderness of the right upper arm, but increased redness to the forearm with minimal tenderness. She received additional intravenous dose of Rocephin on Oct 18 2005. upon examination on Oct 18 2005, the patients right arm was much improved. She was instructed to complete the cephalexin. The patient was reported to have recovered from this event on Oct 18 2005. Additional adverse events described by this reporter include an asymptomatic bacteriuria with negative culture (onset approximately Oct 2005), a pulled muscle on the buttock/leg (onset Oct 24 2005) and pain in the right lower chest that increased with deep breathing (onset Oct 26 2005). No additional information was provided regarding these events. At the time of this report, recovery status for these events was not reported. The reporting manufacturer considered the events to be medically significant (OMIC). Pre existing medical history included corrective lenses, allergies to amoxicillin, Augmentin, and grass and trees, hypertension, Lower extremity edema, physiologic flow murmur, coronary artery disease, hypothyroidism, GERD, Degenerative joint disease, post nasal drip, asthma, cholecystectomy, tonsillectomy, dry cough, syncope, headache, tears in the right medical and lateral menisci and sinusitis.				Y					U	10/13/2005	10/13/2005	0		PVT	UNK	ASA, Atenolol, Caltrate, Hydrochlorothiazide, Levoxyl, Synthroid, Zestril, Ranitidine, Vitamins		Pre existing medical history included corrective lenses, allergies to amoxicillin, Augmentin, and grass and trees, hypertension, Lower extremity edema, physiologic flow murmur, coronary artery disease, hypothyroidism, GERD, Degenerative joint disease, post nasal drip, asthma, cholecystectomy, tonsillectomy, dry cough, syncope, headache, tears in the right medical and lateral menisci and sinusitis.		200502550	1						2	Cellulitis; Chills; Infection; Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth; Tenderness; Cellulitis; Chest pain; Chills; Erythema; Feeling hot; Injection site hypersensitivity; Injection site oedema; Injection site pain; Injection site reaction; Muscle disorder; Tenderness; Urine analysis abnormal	FLU3~SANOFI PASTEUR~U1811AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0753P~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U1811AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0753P~2~SC~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0249008	12/09/2005	SC	89.0	89		F	12/09/2005	Daughter-in-law reported that 10 days post influenza vaccination (11/04/2005) patient became paralyzed.  Was admitted to hospital and was treated for Guillian Barre Syndrome.     12/06/05: Updated report - patient remains hospitalized and has regained some feeling/movement.  Has feeding tube in place and is being treated for bleeding ulcers.   NOTE:  #13 will not allow me to enter greater than 9 previous influenza doses.  Patient has actually received 20+ doses.  Discharge summary includes cough, cold, dysphagia, parethesis, weakness, tachycardia, pneumonia, pneumoperitneum.  Medical records state reflexes decreased.			Y	Y	Y	16	Y		Y	10/25/2005	11/04/2005	10	NONE reported Discharge summary states abnormal chest, abdomenal films; lab tests abnormal. msv	UNK	UNK	NONE reported	NONE	No report Discharge summary states pacemaker, hypertension, arthritis. msv		SC0531	1						1	Asthenia; Cough; Dysphagia; Gastric ulcer haemorrhage; Guillain-Barre syndrome; Hyporeflexia; Laboratory test abnormal; Paraesthesia; Paralysis; Pharyngitis; Pneumonia; Tachycardia	FLU3~SANOFI PASTEUR~U1764AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0249009	12/09/2005	NY	47.0	46		F	12/09/2005	At 48 hours after administration of vaccine redness of 1.5 inches diameter, swelling, warmth to the touch, and pain at the site on the right deltoid.  Patient noted this reaction about 44 hours after administration.									Y	12/07/2005	12/09/2005	2	None	UNK	UNK	Unknown	None	NKDA			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1930AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249021	12/09/2005	NJ	1.08	1	.1	M		Received vaccine 11/03/2005, admitted in heart failure, myocarditis 11/10/2005, Died 11/10/2005. Increasingly cranky for 2 days procedding admission to hospital.	Y	11/10/2005							N	11/03/2005	11/10/2005	7		PUB	PUB	Pulmicort, Zantac, Singulair, Albuterol, AccuNeb	History of RAD	Premie, asthma			1						1	Cardiac failure; Irritability; Myocarditis	FLU3~SANOFI PASTEUR~U1904AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0347R~UNK~IM~LA~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~A25962H~UNK~IM~RA~PNEUMO (PREVNAR)~1	USA	Results in Death	Influenza
0249023	12/09/2005	CT	61.0			F	12/05/2005	Seriousness criteria: other Medically significant (OMIC). Initial report received from a health care provider on Nov 29 2005. A 61 year old female with a medical history of psycho affective disorder received an injection of Fluzone SV 2005-2006, lot number unknown, on a unspecified date in mid Nov 2005. Route and site of administration, and illness at the time of vaccination were unknown. The patient has a history of allergies to penicillin, gentamycin, latex and strawberries. No other pre existing conditions were reported, although the patient is on multiple other medication. Two weeks post vaccination, on Nov 28 2005, she became unresponsive and was examined in an ER. Per the reporter, the cause of the event was diagnosed as due to mercury derivative in the flu vaccine. The patient was released from the hospital. At the time of this report. the recovery status was not reported.				Y					U		11/28/2005			PVT	PVT	Synthroid, Analopril, Trileptal, Depakote, Effexor, Oxybutynin, Fosamax, Norvasc, Lactulose, Protonix, Vitamin D, Oscal, Senokot, Klorcon, Vitamins.		The patient has a history of allergies to penicillin, gentamycin, latex and strawberries.		200502660	1						1	Coma; Hypersensitivity	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249032	12/09/2005	MI	48.0			M	12/06/2005	Information has been received from a 48 year old male consumer with a form of lupus that affects his skin, who on Oct 12 2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included a dose of influenza virus vaccine (unspecified). It was noted that the pharmacist did not clean the site prior to administering the pneumococcal 23v polysaccharide vaccine. It was also noted that both vaccines were given in the same arm. On Oct 13 2005 at 2:00 the consumer went to the emergency room because he felt sick. and the pain in his arm was unbearable. It was noted that his pulse was 118 and his white blood cell count was over 20,000. The consumer stated that his condition was life threatening. He was admitted to the hospital and given IV antibiotics for 3 days. The first antibiotic did not work so he was given a different one for 3 more days, while he was still in the hospital. Laboratory diagnostic studies included blood test. The patient was hospitalized for 6 days. The patient was discharged with cephalexin (Keflex) but had a reaction to it and had to return to the emergency room for treatment. He was prescribed Prednisone for his reaction. The patient was recovering but he was still receiving wound care for the site of the pneumococcal 23v polysaccharide vaccine injection. It was also noted that the patients condition improved after treatment. It was also noted that the patient has never had this type of reaction to an injection before. Prior to these vaccinations, he had not been treated for his lupus for over a year. No product quality complaint was involved. Felt sick, pain in arm was unbearable, white blood cell count was over 20,000 and pulse was 118 were considered to be immediately life threatening. Additional information has been requested.			Y	Y	Y	6			U	10/12/2005	10/12/2005	0	Diagnostic laboratory 10/13/2005 blood test, Total heartbeat count 10/13/2005 118, WBC count 10/13/2005 over 20,000.	OTH	OTH			Lupus erythematosus		WAES0511USA04627	1						1	Heart rate increased; Hypersensitivity; Injection site reaction; Malaise; Pain; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0249041	12/09/2005	CA	43.0	42		M	12/09/2005	About 1 1/2days after injection of FluMist, go the flu, runny nose, congestion, minor cough, aches, and tight chest-every time I inhale to max it hurts in my chest.  Some movement hurts in my chest/heart area.									U	12/05/2005	12/07/2005	2		PVT	OTH	Pravachol 10 mg	NONE	NONE			1						1	Chest discomfort; Cough; Hypokinesia; Influenza; Nasal congestion; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0249042	12/09/2005	OH	2.0	2	.1	F	12/10/2005	Within hrs of vaccine child developed urticaria, eyes shut swollen-Benadryl given									Y	11/23/2005	11/23/2005	0	NONE	PVT	PVT		NONE	NONE			1						1	Eye swelling; Urticaria	FLU3~SANOFI PASTEUR~U1787CA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249043	12/09/2005	CA	4.0	3		M	11/02/2005	Following info given by mother: 11-17-05 c/o fever, vomiting & diarrhea, 11-18-05 no further fever, vomiting or diarrhea, 11-19-05 Left arm swollen with red blotches from deltoid to elbow, 11-21-05 symptoms have diminished slight itching called PMD office.  Not seen.										11/17/2005	11/17/2005	0	NONE	PUB	PUB	NONE	NONE	Allergic-Penicillin, Cephalexin			1						1	Diarrhoea; Injection site erythema; Pruritus; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1770AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249045	12/09/2005	CT	1.0	1	.0	M		Rash began AM of 11/16/05 noted 1st on nape as small dots various sizes then 11/17 spread to arms, legs, chest, head, scalp increased number of spots, size remained same ~5mm diam some with a target on nape; concentrated in warm area of body (axilla, scalp), some with pinpoint central vesicle; on 11/18/05 Pt awoke with swollen eyelids L almost closed, swollen hands and feet.  Fever to 100 F rectal & diffuse rash 1-2 cm diam macular with central vesicle-Pt given 20mg oral prednisone in office and 1mg 1cc/dose every 12 hrs for 3 days-until rash disappeared on 11/21/05.  EM-serum sickness				Y					Y	10/31/2005	11/16/2005	16		PVT	OTH	Augmentin started 11/8/2005 stopped 11/17/2005	Persistent otitis media failed Zitromax clinical	rash on 9/12/05 and one dose Augmentin and 10 days Amoxil			1						1	Eye swelling; Pyrexia; Rash; Serum sickness	FLU3~SANOFI PASTEUR~U1854AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0031R~1~~LL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|VARCEL~MERCK & CO. INC.~0562R~1~~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0249046	12/09/2005	SD	61.0	60		F	12/05/2005	On 11-12-05 in AM noted a painful lump in armpit.  On 11-16-05 was worse and was seen by second physician who put her on Keflex 500mg qid x 10 days.  Resolved as of 12-5-05.				Y					Y	11/10/2005	11/12/2005	2	Unknown-I believe physical exam only	PVT	PVT		NONE	Thimerisol			1						1	Lymph node pain	FLU3~SANOFI PASTEUR~41802IA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249047	12/09/2005	MA				M	11/16/2005	Fever 105, chills, vomiting, diarrhea x 24-48hr then resolved									Y	10/28/2005			NONE	PUB	UNK		NONE	Asthma, allergies:Penicillin, pineapple, grape cake frosting			1						1	Chills; Diarrhoea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~AFLU712580~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249048	12/09/2005	VA	0.54	0	.5	M	11/18/2005	Fluirin by Chiron is indicated for patients older than 4yrs.  Inadvertently given to this 6 month old child.										11/17/2005	11/17/2005	0	NONE	PVT	PVT		NONE	NONE			1						1	Medication error	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62017~1~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0249049	12/09/2005	WI	46.0	46		F	10/18/2005	Around 5 pm the day of getting the flu vaccine began to feel wheezing and SOB.  These symptoms did progress somewhat.  Normal peak flow is 400 at 7pm that evening my peak flow was 250.  Used Albaterol inhaler and steam bath to help symptoms which elected to pass about 9pm.									Y	10/17/2005	10/17/2005	0		PVT	UNK		NONE	Asthma, hypertension (treated)			1						1	Dyspnoea; Wheezing	FLU3~SANOFI PASTEUR~U1833BA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249050	12/09/2005	CA	76.0	76		F	11/18/2005	c/o numbness and pain in left arm at the site of the flu vaccine immediately after administration.  For the next two days after the vaccine, she felt tired and slept.  The third day after the vaccine (11/5) the patient had a rash and itching on her left arm and felt ill.				Y					N	11/03/2005	11/03/2005	0	On 11/11/05, the patient was diagnosed with shingles.	PUB	PUB	Protonix 1/day	NONE				1						1	Fatigue; Herpes zoster; Hypoaesthesia; Injection site pain; Pruritus; Rash	FLU3~SANOFI PASTEUR~U1770AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249051	12/09/2005	NC	67.0	67		F	11/23/2005	Pt received Pneumovax 23 in the right deltoid by intramuscular injection on 11/21/2005 and influenza in the left deltoid. The time was around 4pm. Pt reports having shortness of breath and experiencing tightness in her chest as she traveled up a flight of stairs to her garage apartment later that day. the episode lasted about ten minutes. During the night, other symptoms appeared. around 9:30 pm to 10 pm, pt had shooting pain in her arm, experienced severe shaking of the head and body for 5-10 minutes, throat and nose became dry for about 45 minutes, felt warm and appeared flushed. She also experienced nausea and diarrhea through the night. Pt presented to the health department for further evaluation on 11/22/2005. The nausea had subsided and had a decrease in episodes of diarrhea. She also reported malaise. She did not have a thermometer to measure her body temperature when whe experienced feeling warm the previous night. Pt evalutaed by nurse and upper left arm tenderness and swelling into left axilla was noted. Arm was also warm to the touch, but no paralysis noted. Pt has no drug allergies or food allergies and is currently on three meds: Zoloft 50 mg every day, Diovan HCT, and Verelan. Pt was to report to us if symptoms did not resolve in a 48 hour period or if symptoms worsened, to follow up with primary care doctor or emergency room. Pt contacted health department of 11/23/2005 and stated that swelling had not resolved and that pain had extended into left breast. Pt was advised to follow up with a medical provider and went to an urgent care that day where she was diagnosed with cellulitis and received Keflex 500mg qid for 7 days and Vicoden 500mg for pain. Will continue to follow up with pt until fully resolved.				Y					U	11/12/2005	11/12/2005	0	UNK	PUB	PVT	Zoloft, Verelan, Diovan HCT	NONE	Hypertension, anxiety			1						1	Cellulitis; Chest discomfort; Diarrhoea; Dry throat; Dyspnoea; Feeling hot; Malaise; Nasal dryness; Nausea; Pain; Pyrexia; Swelling; Tremor	FLU3~SANOFI PASTEUR~U1872AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1048P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0249052	12/09/2005	KY	1.3	1	.3	M		Parent states child has four blister type rash marks.  Physician verified Chicken Pox total of 6 pox on child-no other S/S, well and dried pox 12-5-04.									Y	11/14/2005	12/02/2005	18	NONE	PUB	UNK	NONE	Has dry skin patches not requiring meds	Eczema-physican told parent it was dry skin or detergent reaction no meds required.			1						1	Blister	DTAP~SANOFI PASTEUR~U1369CB~4~~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~0186AA~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0898P~1~~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0249053	12/09/2005	OR	5.0	5		M	12/02/2005	L arm red and hot entire L arm									Y	11/28/2005	11/30/2005	2	NONE	PVT	PVT	Amoxicillin	Ear infection				1						1	Feeling hot; Injection site erythema	DTAP~SANOFI PASTEUR~C2254AA~5~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1754AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0496~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0240R~2~SC~RA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA		Influenza
0249054	12/09/2005	FL	4.0	4		F	12/01/2005	Induration and swelling 7x8cm on L deltoid noted on 28-30 H after injection.  Q fever given Robitussin and Albuterol for associated cough and wheezing noted as 32 Hp.										11/29/2005	12/01/2005	2		PVT	PUB		NONE	NONE			1						1	Cough; Injection site induration; Injection site oedema; Pyrexia; Wheezing	DTAP~SMITHKLINE BEECHAM~AC14B002BA~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1912AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~40343~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0603R~2~SC~LA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA		Influenza
0249055	12/09/2005	MI	1.51	1	.5	M	11/14/2005	red ear with itching, blotchy rash. Rash treated with Rx Benadryl 1/4 tsp every 4 hours- completey cleared in 6-8 hrs. Was not seen in office.									Y	11/09/2005	11/09/2005	0		PVT	PVT		NONE				1						1	Pruritus; Rash; Skin irritation	FLU3~SANOFI PASTEUR~U1743HA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249056	12/09/2005	CA	45.0	45		M	12/07/2005	Events reported on 12/6/05. Following flu shot to left deltoid, patient complained of swelling and pain to left shoulder. Patient stated it was so painful I had to take Vicodin for a couple of weeks. Duration of severe pain approximately 2 weeks, though very painful for 4 weeks total. Seen by personal physician, MRI completed - normal. Full ROM to left shoulder.				Y					Y	10/12/2005	10/12/2005	0	MRI normal.	PVT	PVT	Naproxen; Claritin	Denies	Allergies: Penicillin, Erythromycin, Tetracycline; Pollens; Yellow dye; Grasses; Medical Conditions: Carpal tunnel, Bakers asthma (in past).			1						1	Pain; Shoulder pain; Swelling	FLU3~SANOFI PASTEUR~U1832BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249057	12/09/2005	CA	4.0	4		F	11/21/2005	Eyrthema and swelling around site of shots on left arm - 2 x 2 cm induration 2.5 x 3.5 cm - mother  Rx possible infection.										11/10/2005	11/11/2005	1		PVT	PVT						1						1	Infection; Injection site erythema; Injection site induration; Injection site swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14A006CA~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1802CA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y032S2~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0382R~2~SC~RA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA		Influenza
0249058	12/09/2005	DE	0.74	0	.7	M	11/02/2005	Itching within 12 hour post shot wheezing that evening - wheeze persists - on albuterol and pulmacort via nebulizer									Y	10/27/2005	10/27/2005	0		PVT	PVT						1						1	Pruritus; Wheezing	FLU3~SANOFI PASTEUR~VF62AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249059	12/09/2005	OH	55.0	54		F	12/05/2005	Vaccine 11 am 12/08/05. Ill around 5 pm. Cold back, face warm, hot itchy eyes and head, headache, puffy eyes. All symptoms x 2 days, weakness and swollen throat. Did not go to ER/doctor. All resolving except still feeling weak.									N	12/03/2005	12/03/2005	0		UNK	UNK			Headaches- migranes			1						1	Asthenia; Eye disorder; Eye oedema; Feeling cold; Headache; Pharyngeal oedema; Pruritus; Skin warm	FLU3~SANOFI PASTEUR~U1872AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249060	12/09/2005	AZ	55.0	55		F	12/06/2005	Received immunization at 3 pm. Adverse reaction started at 7 pm following a work out. Cough, sore throat, chills, burning in both eyes, low grade fever, body aches, whole body trembling. Lasted until 11 pm. Next day had headache and very fatigued, diarrhea began and has not stopped.									N	11/10/2005	11/10/2005	0		PVT	UNK			Celiac, spruce			1						1	Chills; Cough; Diarrhoea; Eye pain; Fatigue; Headache; Pain; Pharyngolaryngeal pain; Pyrexia; Tremor	FLU3~AVENTIS PASTEUR~U1832BA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249061	12/09/2005	NC	26.0	25		F	12/09/2005	Approximately 5 hours after vaccination pt experienced Double vision, Dizziness, Nausea, Headache and Racing Heart. Pt called Health Dept and was referred to PMD. Pt states PMD diagnosed viral syndrome and prescribed Naproxen.				Y					Y	11/30/2005	11/30/2005	0		UNK	UNK	none	none reported	none			1						1	Diplopia; Dizziness; Headache; Heart rate increased; Nausea; Viral infection	FLU3~SANOFI PASTEUR~U1872AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249062	12/09/2005	CT	32.0	32		F	12/09/2005	Patient stated that within 2-3 minutes following injection began experiencing dizziness, sweating, and tingling everywhere. Prior to injection told nurse that she was petrified of needles. She did not indicate that she was experiencing anything until about 7-8 minutes following injection.  She was placed on the floor in Trendelenburg position and given coke to drink.  Her color was good, pulse normal, and was not diaphoretic.  She remained on the floor for about 10 minutes.  Left clinic site with no complaints.									Y	12/08/2005	12/08/2005	0	none	UNK	UNK	none		Allergic to Penicillin and Erythromycin			1						1	Dizziness; Hyperhidrosis; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~63193~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0249064	12/09/2005	MI	23.0	23		F	12/09/2005	Ten minutes after receiving vaccination alerted nurse she had breathing issues, nurse observed rapid breathing, anxious; sent to urgent care and was transported via ambulance to where she received treatment (benadryl & epinepherine) for an allergic reaction, chest x-ray, respiratory work-up.  Prescribed prednisone.				Y					Y	12/06/2005	12/06/2005	0		UNK	UNK	None	Denies	Denies			1						1	Anxiety; Dyspnoea; Hypersensitivity	FLU3~SANOFI PASTEUR~U1838AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249071	12/09/2005	IL	71.0	71		F	12/09/2005	Patient notified us regarding rt. arm redness, swelling in upper arm 3x5 area, warm to touch. 8-10 hours after injection.  Took tylenol, took it easy.									U	10/25/2005	10/25/2005	0		UNK	UNK	Unknown	Unknown	unknown			1						1	Erythema; Injection site warmth; Swelling	FLU3~SANOFI PASTEUR~u1836aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577p~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249072	12/09/2005		63.0	62		M	12/09/2005	1 week following flu vaccine started to feel tingling numbness in toes/fingertips. LE weakness which is progressively worsening over past 4 weeks, increased reflexes. Medical records state Hypertonia, pain. msv				Y	Y					10/26/2005	11/04/2005	9	Medical records state abnormal lab tests. msv	UNK	UNK			Discharge summary states hypertension, renal failure, arthritis, polycythemia.  Medical records state obesity, constipation, spontanious bone fx. msv			1						1	Asthenia; Hyperreflexia; Hypertonia; Hypoaesthesia; Laboratory test abnormal; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0249073	12/09/2005	IL	69.0	68		F	12/09/2005	On 10-21, notified us of Lt arm red 1 inch in diam.  Rt arm bruised.  Patient is on Plavix. Noticed the redness 24 hours after shot.									U	10/20/2005	10/21/2005	1	Unknown	UNK	UNK	unknown	unknown	unknown			1						1	Contusion; Erythema	FLU3~SANOFI PASTEUR~u1905aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577p~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249082	12/09/2005	WA	43.0	42		M	12/07/2005	Temperature during 3 days. Sunday am severe chest pain. Shot went through arm pit extreme pain. Rash outlined like bulb, under arm pit and chest areas very tender				Y					Y	12/03/2005	12/03/2005	0		PUB	UNK	melformin, lauters, hemalog, multivit		diabetes			1						1	Chest pain; Pyrexia; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0249084	12/09/2005	FL	69.0	68		F	12/09/2005	At night, chills and sweats began and fever of 101 took aspirin. On Wednesday symptoms on and off. Red blotch appeared 2 inches below injection sites, a streak appearred on one side. Today, doctor diagnosed it as phebotis type reaction. Red and hard in certain areas. Prescribed cephalexin for next 2 weeks. (500 mg, 3 x day)				Y					U	12/06/2005	12/06/2005	0		PUB	PUB	lipitor, actonel, toradol		asthma			1						1	Cellulitis; Chills; Erythema; Hyperhidrosis; Phlebitis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0249077	12/11/2005	NV	48.0	47		F	12/11/2005	Developed a severe case of cellulitis. Fever, chills, sweats, swelling on site of needle in right arm and severe swelling and redness in area next to where needle when in.  Extreme pain for 5-7 days.  Put on antibiotics, ceflex and cipro, pain relievers, and steroids.				Y					Y	12/01/2005	12/02/2005	1		UNK	UNK		No illness.  I was bit by a student and needed to receive a tetanus shot.  I had a cold in November when the flu shot was given at my school, so I wanted to have it as well as the pneumonia shot done at the clinic while I was there.				1						1	Cellulitis; Chills; Hyperhidrosis; Injection site erythema; Injection site swelling; Pyrexia	DT~BSI~~UNK~~~DT ADSORBED (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0249080	12/12/2005	PA	0.55	0	.6	M	12/12/2005	Infant began flailing/self-stimming on 12-25-04. Infant stopped babbling, eating, was irritable, not cuddly, had disturbed sleep problems, and was diagnosed with autism spectrum on 8-10-05. Medical record states congenital muscle anomally. msv  Per annual follow-up: Encepholathy, speech and language regression, cognitive impairment, autism, global developmental delay, severe egg and peanut allergy, severe gastric intestinal issues.  Additional comments: Children should not be made to receive these shots. Parents should have informed consent .  Our twins received this vaccine at 6 months and just shy of 7 months. Follow-up: Patient still has dx of regressive encephalopathy w/ features of autism.								Y	N	11/30/2004	12/25/2004	25		UNK	UNK	Zithromax	double ear infections and upper respiratory infection.	ezcema, soy intolerance, developmental delay	later dx of autism~Influenza (Seasonal) (Fluzone)~1~0.60~Patient|~Influenza (Seasonal) (Fluzone)~~0.00~Sibling|later dx of autis		1						1	Abnormal behaviour; Autism; Cognitive disorder; Developmental delay; Irritability; Oral intake reduced; Regressive behaviour	DTAP~SANOFI PASTEUR~C2103AA~3~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1442AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE396AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A57861F~3~IM~RL~PNEUMO (PREVNAR)~1|UNK~UNKNOWN MANUFACTURER~X1240~3~IM~LL~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA	Disabling	Influenza
0249081	12/12/2005	MD	0.55	0	.6	M	12/12/2005	Infant stopped babbling, looked at us as though he did not know who we were, began gazing, stopped eating, was irritable, not cuddly, had disturbed sleep problems, began surface scanning objects, crossing eyes, and was diagnosed with autism spectrum on 8-10-05. Medical record states congenital abnormality. msv Encephalopathy, speech and language regression, cognitive impairment, autism, gilobal dev. delay severe egg & peanut allergy, severe GI issues.  This should not be a mandated vaccine.  Our twins received this vaccine at 6 months and just shy of 7 months.  Parents should be informed. Follow-up: Patient still has a dx of regressive encephalopathy w/ features of autism.								Y	N	11/30/2004	12/30/2004	30		UNK	UNK	albuterol, amoxicillan	breathing difficulty	eczema, milk and soy intolerance, developmental delay, Medical record states asthma . msv	later dx of autism~Influenza (Seasonal) (Fluzone)~1~0.60~Patient|later dx of autism~Influenza (Seasonal) (Fluzone)~1~0.60~Siblin		1						1	Abnormal behaviour; Autism; Cognitive disorder; Congenital anomaly; Encephalopathy; Food allergy; Irritability; Oral intake reduced; Sleep disorder; Staring; Strabismus	DTAP~SANOFI PASTEUR~C2103AA~3~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1442AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE396AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A57861F~3~IM~RL~PNEUMO (PREVNAR)~1|UNK~UNKNOWN MANUFACTURER~X1240~3~IM~LL~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA	Disabling	Influenza
0249085	12/12/2005	TX	0.51	0	.5	F	12/09/2005	Urticaria									Y	12/05/2005	12/05/2005	0	NONE	PUB	PUB	NONE	NONE				1						1	Urticaria	DTAP~SANOFI PASTEUR~U1348DA~3~~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1743NA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0160V~1~~LL~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~A25964F~4~~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0249086	12/12/2005	OR	72.0	71		F	12/09/2005	Pain in right arm starting 2 days post vaccination. Still unable to lift arm. Has not visited a doctor as of 12/04/2005.									U	10/20/2005	10/22/2005	2		OTH	PUB			UNK			1						1	Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U1811AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577P~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249114	12/12/2005	OH	53.0			F	12/06/2005	Initial report received on 12/5/05 from a health care provider. An adult female patient received an IM injection of Fluzone SV 2005-2006, lot number U1930AA, on an unspecified date. Number of previous doses was reported as one.  Within five minutes of receiving the vaccine, she had a seizure. An ambulance was called. However, the patient refused transport. There was no illness at the time of vaccination and no known pre-existing medical conditions. The patient will reportedly follow up with her physician. At the time of this report, the patient had fully recovered. (OMIC)				Y					Y					UNK	UNK					200502712	1						1	Convulsion	FLU3~SANOFI PASTEUR~U1930AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249117	12/12/2005	MD	53.0	52		F	11/30/2005	Red, swollen, tender area on right deltoid where flu vaccine was administered.									U	11/28/2005	11/30/2005	2		OTH	UNK	Fosamax	NONE	Sulfa			1						1	Injection site hypersensitivity; Injection site oedema; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62216~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0249118	12/12/2005	FL	81.0	81		M	12/05/2005	Pt with febrile illness, myalgias, sore swollen arm at site.									Y	11/16/2005	11/17/2005	1		PVT	PVT			Diabetes mellitus, Atrial fibrillation, HX colon Cancer, Hypertension.			1						1	Injection site oedema; Injection site pain; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1869AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249119	12/12/2005	CA	1.1	1	.1	F	12/07/2005	Mother notice reaction the night that the vaccines were given. The area where shot were given was warm and red pt had no symptoms. R leg 80 x 40 cm left 30 x 10 cm.									U	12/05/2005	12/06/2005	1		OTH	OTH						1						1	Feeling hot; Injection site hypersensitivity	DTAP~SANOFI PASTEUR~C2207AA~UNK~~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~SP417656A~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE723AB~UNK~~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0612P~UNK~~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A74406E~UNK~~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0194P~UNK~~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0249120	12/12/2005	MN	13.0	13		M	12/02/2005	Arthus reaction (redness, swelling, wheezing, lymphadenitis, intermittent chest pain.									Y	11/21/2005	11/22/2005	1	Albuterol and Pulse and Taper Q steroids.	PVT	PVT	Albuterol, Robinul, Advair Disc, Zyrtec, Rhino Covet	NONE	Chromosome defect.			1						1	Chest pain; Erythema; Lymphadenitis; Oedema; Type III immune complex mediated reaction; Wheezing	FLU3~SANOFI PASTEUR~U1915AA~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1004P~1~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249121	12/12/2005	NE	64.0	64		M	11/18/2005	Patient called 11/08/2005 and had described Pain in injection arm after flu shot, subsiding and state tingling in left hand, pinkie, and ring finger. Recommended to patient that if continues or worsens to contact his doctor and make appointment.									U	10/17/2005	11/08/2005	22		OTH	PVT	UNK	UNK	UNK			1						1	Injection site pain; Paraesthesia	FLU3~SANOFI PASTEUR~U1806AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249122	12/12/2005	MA	61.0	61		F		Immediate itching, later hot to touch and red for about 5 days.									Y	11/20/2005	11/20/2005	0		PUB	OTH	Aspirin, Vitamins					1						1	Erythema; Feeling hot; Pruritus	FLU3~SANOFI PASTEUR~U1836AB~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249123	12/12/2005	MN	1.11	1	.1	F	12/05/2005	Redness, warmth, swelling, around vaccine site started 48 hours after vaccine, cellulitis diagnosed. Treated with Augmentin.									U	11/22/2005	11/24/2005	2		PVT	UNK		NONE	NONE			1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U1867CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0356R~3~IM~LL~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~B08643B~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0356R~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0249124	12/12/2005	NY	1.26	1	.3	F	12/06/2005	Pharyngeal swelling, urticaria, right arm swelling, required epinephrine, Steroids, Diphenhydramine.				Y					Y	11/30/2005	12/01/2005	1		PVT	PVT	NONE	NONE	Asymptomatic inversion chromosome 11, seizures age 4-5 months only.			1						1	Oedema; Pharyngeal oedema; Urticaria	DTAP~SANOFI PASTEUR~C2325AA~4~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1854AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A56077K~4~IM~RA~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0333R~1~IM~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0249125	12/12/2005	HI	57.0	57		F	12/01/2005	Arthralgias, Myalgias, increased sed rate 50.				Y					Y	10/29/2005	11/01/2005	3	Increased sed rate 50, ANA neg CBC-WNL, LTS	UNK	PVT		NONE	Keflex, Antihistamine, PCN		HI0508	1						1	Arthralgia; Myalgia; Red blood cell sedimentation rate increased	FLU3~SANOFI PASTEUR~U1754AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249126	12/12/2005	HI	75.0	75		M	12/07/2005	Severe arthritis left shoulder and left knee on day after vaccine.				Y					Y	11/10/2005	11/11/2005	1	Sed rate 107, WBC 10.2,Uric acid, rheuma factor neg.	PVT	PVT	Nifedipine, Glyburide, Medizine	NONE	Diabetes, Hypertension, Hyperlipidemia		HI0507	1						1	Arthritis; Red blood cell sedimentation rate increased; White blood cell count increased	FLU3~SANOFI PASTEUR~U1754AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249127	12/12/2005	HI	77.0	77		M	12/01/2005	Arthralgias, myalgias, fever 102.				Y					Y	11/17/2005	11/18/2005	1	NONE	PVT	PVT	Thyroxine, Plavix, Aciphex	NONE	Tetanus, sulfa		HI0506	1						1	Arthralgia; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1754AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249128	12/12/2005	MT	26.0	26		F	12/08/2005	Hives, sensation of throat closing, Given epinephrine x 2 and taken to hospital.				Y					Y	11/29/2005	11/29/2005	0		PVT	PVT	NONE	NONE	History of asthma, well controlled.			1						1	Throat tightness; Urticaria	FLU3~SANOFI PASTEUR~U1868AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249130	12/12/2005	OR	22.0	22		F	10/27/2005	Redness, swelling, tenderness, sore and itchy.										10/25/2005	10/27/2005	2		PVT	OTH	Metformin, Glyburide, Diabetic medication.	NONE	Diabetes			1						1	Erythema; Oedema; Pain; Pruritus; Tenderness	FLU3~SANOFI PASTEUR~U1816AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249131	12/12/2005	AZ	17.0	16		F	12/01/2005	Pt received Menactra and Tdap in right deltoid about 10 hours later developed swollen arm to fingers with numbness, C?O wrist pain slowly improving.				Y					U	11/28/2005	11/28/2005	0		PVT	PUB						1						1	Hypoaesthesia; Oedema; Pain	FLU3~SANOFI PASTEUR~U1754AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1821AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2151AC~1~IM~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0249143	12/12/2005	DC	25.0	24		F	11/30/2005	Myalgia and Flu like symptoms, Papillar skin rash on abdomen and thighs 24-48 hrs post vac administration.  No fever.  Symptoms resolved 72 hrs post vaccination.  No treatment given.									Y	11/23/2005	11/25/2005	2	NONE	PVT	PUB	Orthotricycinne, BCP, Doxcycychline, Claritin 11/22/2005 only	NONE	ASA-NSAID, Sensitivity-reaction easy bruising			1						1	Influenza like illness; Myalgia; Rash	FLU3~AVENTIS PASTEUR~208032~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249146	12/12/2005	IL	67.0	67		F	12/12/2005	On 12/8/05, patient contacted me regarding a swelling and redness in  her right arm.  This arm she received a pneumonia shot on 12/8/05.  The reaction began about 24 hours after the shot.  Her daughter is an R.N. and suggested that she notify us regarding the problem.  I advised her to keep her arm elevated and apply ice.  In the event the events became worse over the weekend to call her physicians exchange.  She also said she would let me know this week on how she is doing.									U	12/08/2005	12/09/2005	1	Unknown	UNK	UNK	Unknown	Unknown	Unknown			1						1	Erythema; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61549~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1038p~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249148	12/12/2005	WI	0.64	0	.6	F	12/12/2005	The patient had her shots yesterday. Last night, she developed a 103 fever. Her twin sister had the same shots and she developed same symptoms. She has had runny nose for one week, but she did not seem at all sick. After her first set of shots on 8/31/05, she had fever up to 104, which lasted three days and resolved spontaneously. After her second set of shots, she had no problems. The shots that were given both the first and thrid times are the HIB and PREVNAR. Fevers this time lasted 48 hrs.									Y	12/02/2005	12/02/2005	0		UNK	UNK	NONE	SEE NOTE IN BOX 7	NONE	FEVER TO 104 STARTING 4 HRS AFTER IMMUNIZATIONS AND LASTING 72 HRS.~Hib (PedvaxHIB)~1~0.20~In Patient		1						1	Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1867DA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0362R~2~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~A98341A~2~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0249149	12/12/2005	WI	0.64	0	.6	F	12/12/2005	She received some immunizations day before being seen. 3-4 Hrs later she developed high fever to 103. She has no other symptoms now, except for a little runny nose, which she has had for about 1 wk. After her first set of shots, she had a high fever to 104 lasting 72 hrs, along with her twin sister. With the second set of shots, she had no reactions. The fever after the first set of shots started 3-4 hours after receiving the immunizations and lasted 72 hrs. The shots that were given both first and third times are the HIB and PREVNAR.									Y	12/02/2005	12/02/2005	0	none	UNK	UNK	NONE	SEE NOTE IN BOX 7	NONE	FEVER TO 104 STARTING 4 HRS AFTER IMMUNIZATIONS AT 2MOS AGE AND LASTING 72 HRS.~Hib (PedvaxHIB)~1~0.20~In Patient|FEVER TO 104 S		1						1	Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1867DA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0362R~2~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~A98341A~2~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0249150	12/12/2005	OH	44.0	43		M	12/12/2005	Persistant pain at the injection site, small palpable nodule at the site.									U	10/06/2005	10/06/2005	0		UNK	UNK						1						1	Injection site mass; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA130BB~1~SC~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249151	12/12/2005	MS	5.0	4		F	12/02/2005	ON 12/1/05 P.M. PATIENTS ARM BELOW SITE OF INJECTION TURNED PURPLISH-RED AND WAS VERY HOT. MOTHER TOOK CHILD TO NP @ 3 P.M ON 12/2/05 AND WAS TOLD THAT CHILD HAD CELLULITIS. RX FOR ANTIBIOTICS, STEROIDS, AND BENADRYL. RED AREA MEASURES ABOUT 2 1/2 INCHES BY 1 1/2 INCHES.				Y					Y	11/30/2005	12/01/2005	1	NONE	UNK	UNK	XOPONEX NEBULIZER				MS0524	1						1	Cellulitis; Injection site erythema; Injection site reaction; Injection site warmth	FLU3~SANOFI PASTEUR~U1915AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249152	12/12/2005	PA	47.0	47		F	12/12/2005	Flu vaccine administered at approx 2 pm, at approx. 5:45pm, patient thought she had something lodged in throat.  looked in mouth and observed swelling in throat and had nerve pain in mouth and throat area also experienced chest pain across front and back, had coughing and runny nose. Took Baclofen and aspirin and laid down.  At approx. 10pm, her symptoms subsided.									Y	11/09/2005	11/09/2005	0		UNK	UNK	baclofen		multiple sclerosis			1						1	Chest pain; Cough; Neuralgia; Pharyngeal oedema; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1777AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249153	12/12/2005	CT	64.0	63		M	12/12/2005	Patient admitted to hospital 12/9/5 with an acute, rapidly ascending motor weakness diagnosed as Guillain-Barre, for which he received a 5 day course of IVIG followed by inpatient rehab (ongoing at the time of this report).  The patient had no URI or GI symtoms or sick contacts in the preceeding 4 weeks (he did have his usual chronic smoker's cough but no acute change in sputum).  The patient's symtoms began on 12/8/5; he had received the flu vaccine at work on 12/6/5.  The patient had received flu vaccines at this same place of work over the last 12 years without any remembered ill effect. Medical records state paresthesia. msv				Y	Y	5			U	12/06/2005	12/08/2005	2	12/9/5 CSF: protein 124, wbc 1 12/9/5 EMG: widespread demyelinating             polyradiculoneuropathy 12/9/5 MRI: no acute spinal lesions Medical records stte CSF abnormal.	UNK	UNK	Benicar/HCTZ Vytorin Pletal Lumbar Depo-Medrol 07/08/04                    02/25/05                    12/07/05	none Medical records state pain in back. msv	L2-L3 herniated disc PAD (right lower extremity) HTN Dyslipidemia Medical record stes tobacco dependance, perpherial vascular disease. msv			1						1	CSF test abnormal; Cough; Demyelination; Guillain-Barre syndrome; Hypokinesia; Laboratory test abnormal; Neuropathy; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~63350~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0249154	12/12/2005	AK	4.0	4		M	12/12/2005	Significant swelling to right thigh.  Swelling was from the groin to below the knee.									U	12/08/2005	12/09/2005	1		UNK	UNK	none	none	none			1						1	Joint swelling; Swelling	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~~1~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~~5~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0249155	12/12/2005	OH	57.0	57		M	12/12/2005	Patient developed acute disseminated encephalomyelitis.  Flu vaccination received on October 6, 2005.  Symptoms began 9 days post flu vaccination, on October 14, 2005.  Patient had high blood pressure, weakness in the left hip and a left facial palsy.  The symptoms progressed and on day October 16, 2005 he presented to the ER in the morning.  By the evening he was admitted later that eventing he was completely paralyzed from the chest down on the left side, including complete foot drop.  He was positive for Babinski on the left.  He was admitted to the neuro critical care unit at hospital.  He received 5 days of IV solumedrol, 1000mg (October 17-21, 2005).  He was discharged home on October 21, 2005 day.  He began physical therapy for the left leg.  On November 3, 2005 he began complaining of double vision.  This was initially attributed to the Pred taper, however, was diagnosed with optic neuroitis within the next week.  Within the next week he also began to repeat himself and became increasingly confused.  His symptoms progressed and he was ultimately taken to the ER for and emergent MRI on November 21, 2005.  That MRI revealed new inflammatory lesions in the cervical cord and in the right parietal lobe of the brain.  He was oriented to person and place but not to time.  He was admitted to the medical ICU and was started on another course of IV solumedrol, 1000 mg for 9 days.  He was disoriented, had short term memory loss and could not walk on his own.  Later in the ICU stay he was evaluated by physical, occupational and speech therapists. Each found that he had moderate impairment.  He remained in the medical ICU until November 25, 2005 when he was transferred to the neuro critical care unit.  He had improved somewhat on the solumedrol.  On November 26, 2005 he was transferred to the neurology step-down unit.  He remained in the neuro step-down unit until November 29, 2005 when he was transferred to the rehab unit at hospital.  He received one hour per day of each, speech, occupational and physical therapies.  He continued to improve physically, however, the cognative impairment of short term memory loss, confusion and organization problems persisted.  On December 1, 2005 it was found that he had developed HIT Syndrome and was transferred back to the neuro step-down unit for seven days of treatment with an alternative anticoagulant.  He continued to improve physically and mentally and was deemed stable for discharge on December 9, 2005.  On that date he was discharged home with orders for physical and speech therapies.  His medications are Prednisone 100 mg QD, Zoloft 50 mg QD, Neurontin 300 mg TID, Protonix and Coumadin.  On December 12, 2005 it was determined that the Coumadin therapy was not necessary and it was discontinued.  The patient will remain on all other medications until March 1, 2005 at which time he has a follow up appointment with doctor. Per 60 day follow up report-Patient's vision in the left eye has recovered to 70/20 with a 95% visual field. He continues to recover his mental status however still struggles with math/numbers and is not as mentally sharp as he was prior to the the injury. He is expected to make a full recovery, however, it is anticipated that it will take 6 months or more. He has not yet returned to work.  Per annual follow-up: Continued cognitive deficits include difficulty with sequencing expression, urinary reasoning and attention. He also continue to have significant visual problems as a result of persistent optic nuritis. The patient has been unable to return to his career as a physician/surgeon. It is unknown whether he will ever recover sufficiently such that he can return to work.					Y	25			N	10/06/2005	10/16/2005	10	4 MRIs completed over 8 weeks.  Showed inflammatory lesions in the cervical and thoracic spinal cord and the right parietal lobe of the brain.	UNK	UNK	None.	None.	None.			1						1	Amnesia; Asthenia; Cognitive disorder; Confusional state; Difficulty in walking; Diplopia; Disorientation; Encephalitis; Extensor plantar response; Facial palsy; Heparin-induced thrombocytopenia; Nuclear magnetic resonance imaging; Optic neuritis; Paralysis; Speech disorder	FLUX~UNKNOWN MANUFACTURER~~7+~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0249158	12/12/2005	PA	5.0	4		M	12/12/2005	Cellulitis around DTaP site - 8cmx4cm indurated, warm, tender, swelling at left deltoid, noted 2 days after immunization in office. No fever. Patient was admitted to hospital for IV antibiotics. 2/10/06 Review of d/c summary confirms diagnosis of cellulitis of left upper arm treated with Clindamycin. Patient was discharged one day following admission.				Y	Y	1			Y	12/07/2005	12/08/2005	1		PVT	PUB	Zithromax	Strep Throat	2/10/06 - Review of d/c summary indicates child has allergy to PCN.			1						1	Cellulitis; Injection site induration; Injection site reaction; Injection site swelling; Injection site warmth; Tenderness	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B006AA~UNK~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1844AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0460~UNK~SC~~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~029R~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Hospitalisation	Influenza
0249159	12/12/2005	IA	8.0	8		M	12/12/2005	Site of pneumovac very reddened, warm to tocuh, painful per patient,									U	12/09/2005	12/10/2005	1	NONE	PVT	PVT		NONE	Pneumonia, bronchitis			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U1849AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0691P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249160	12/12/2005	NY	50.0	49		M	12/09/2005	Injection site sore.  By weekend semi productive cough began and took Mucinex which helped.  On Monday 12/5, felt panicky; woke up in middle of night feeling cold and shivering uncontrollablly.  Also had a burning headache.  On Tuesday was in bed all day feeling sick.  At night shivering , shakes began again as well as headache.  On Wednesday was seen by chronic fatigue specialist who gave him a gammoglobulin, B-12 and vitamin intravenous drip.  Mentioned it was a neuropathy because had intense pain on feet.  Wednesday night slept much better but was either too hot or cold coughing to the point of chest pains.  Took Prednisone.  Yesterday felt better had sinus irritation, brown discharge when coughing.  Today felt roughness on mouth and discovered a fungal infection, began to take Diflucan and clotrimazole.				Y					U	12/01/2005	12/01/2005	0		PVT	PVT	Singular, Metformin, Topamas, Lipitor, Lexapro, Clonazepan, Nexium, Accupril, Methadone, Imitrex, Codeine, Nasacort, Mucinex, Predinsone, Dicyclomine, Diflucan	NONE	Chronoic fatigue syndrome, fibromyalgia, diabetes, growth hormone deficinecy, Immune system problems, Krontiyhoid, Hepatitis C.			1						1	Chills; Cough; Fungal infection; Headache; Injection site inflammation; Pain in extremity; Sinusitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0249161	12/12/2005	TN	5.0	4		M	12/12/2005	The patient returned to our office approximately 1-2 hours after receiving flu shot, MMR, DTap, and IPV.  He had generalized urticarin, diffuse wheezing, and decreased blood pressure (88/64).  He was given 3 tsp Orapred, Benadryl 25 mg & Xspenex 1.25mg.  Ten minutes later wheezing & urticaria resolved and BP was 98/74.				Y					Y	12/09/2005	12/09/2005	0		PVT	PUB	NONE	NONE	NONE			1						1	Blood pressure decreased; Urticaria; Wheezing	DTAP~SANOFI PASTEUR~C2253AA~5~~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1914AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0496~4~~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0153R~2~~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA	Emergency room visit	Influenza
0247509	12/13/2005	IA	77.0	77		F	11/10/2005	Pneumonia vaccine administered 10/31 in right deltoid. Developed right arm swelling 10/31 through 11/4. Sore, unable to use right arm.									Y	10/31/2005	10/31/2005	0		PUB	UNK			UNK		IA05016	1						3	Feeling hot; Hypokinesia; Pain; Swelling; Hypokinesia; Pain; Swelling; Hypokinesia; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0792P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~0792P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~2|PPV~MERCK & CO. INC.~0792P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~3	USA		Influenza
0249165	12/13/2005	NE	1.25	1	.3	F	12/07/2005	Information has been received from a health professional concerning a 15 month old female who on Nov 18 2005 was vaccinated with a 0.5ml dose of varicella virus vaccine live (lot 646669/0626R). Concomitant vaccinations that day included a dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) and a dose of influenza virus vaccine (unspecified). On Nov 19 2005 the patient developed cellulitis at the injection site with a pea sized lump at the center. The patient went to an urgent care  clinic on Nov 19 2005 and was treated with cephalexin (Keflex). Over the next week the lump tripled in size and started to itch. The child was taken back to the urgent care clinic and placed on sulfamethoxazole (+) trimethoprim (Bactrim). The child was assumed to be recovering. There was no product quality complaint involved. The patients adverse experiences were considered to be other important medical events (OMIC). Additional information has been requested.				Y					Y	11/18/2005	11/19/2005	1		OTH	OTH					WAES0512USA00217	1						1	Cellulitis; Injection site mass; Injection site reaction; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HBHEPB~MERCK & CO. INC.~~UNK~UN~UN~HIB + HEP B (COMVAX)~1|VARCEL~MERCK & CO. INC.~6466690626R~UNK~UN~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0249182	12/13/2005	TX	1.53	1	.5	F	12/12/2005	Right thigh presented a 3 diameter erythema, tender, and indurated, this is where DTaP was given. TX Clindamycin.				Y					U	12/10/2005	12/10/2005	0		PVT	PVT						1						1	Injection site erythema; Injection site induration; Injection site reaction; Tenderness	DTAP~SANOFI PASTEUR~C2044AA~4~~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1775AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08634K~4~~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0249183	12/13/2005	MO	0.82	0	.8	F	11/23/2005	Development of welps over trunk, arms, legs, onset within 12 hours. Seen in ER 10/21/2005.				Y					Y	10/18/2005	10/18/2005	0		OTH	OTH	NONE	Fever 100.2, Viral	NONE	~Hib (no brand name)~2~0.33~In Patient		1						1	Urticaria	FLU3~SANOFI PASTEUR~U1761AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249184	12/13/2005	MD	59.0	58		F	11/28/2005	Itching at site of injection, also noted red blotching consistent with shape of band aid. Also approx 4x4 area upper left arm. PMD notified advised to give Benadryl 25 mg IM, irritation, inflammation resolved approx 20 min.									Y	10/26/2005	10/26/2005	0	NONE	PUB	PUB	UNK	NONE	NONE			1						1	Erythema; Inflammation; Injection site reaction; Pruritus; Rash macular; Skin irritation	FLU3~SANOFI PASTEUR~U1904AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249185	12/13/2005	GA				U		Became dizzy Fri - Sunday, I have too much difficulty reading this.									Y	11/14/2005	11/18/2005	4		PUB	PVT						1						1	Dizziness	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0249186	12/13/2005	PA	63.0	62		M	11/17/2005	Swelling of tongue.									Y	11/15/2005	11/15/2005	0		PVT	OTH			IV's, Betadine, Zithromax, Bee sting.			1						1	Tongue oedema	FLU3~SANOFI PASTEUR~U1210CA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249187	12/13/2005	CA	42.0	41		F	12/07/2005	Pt was administered .5cc of Influenza vaccine, 20-30 mins later, pt came back c/o severe itching, urticaria down left arm, and chest tightness, sob. I administered .3cc of EPI 1:1000 IM in left deltoid at 12:02 while a desk clerk dialed 911. Obtained VS as ER staff came in. BP 182/96, P 199, SP O2 99%,				Y					Y	12/07/2005	12/07/2005	0		OTH	MIL	NONE	NONE	NONE			1						1	Chest discomfort; Dyspnoea; Heart rate increased; Hypertension; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1935AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249188	12/13/2005	NC	61.0	60		M	12/07/2005	Nausea, subjective fever at 104F, dizziness, blurry vision, vomiting, chills, SOB.				Y						12/02/2005	12/02/2005	0	CXR, CBC, CMP	PUB	PUB			Peripheral vascular disease, Coronary artery disease, hypertension, Nicotine Addict.			1						1	Chills; Dizziness; Dyspnoea; Nausea; Pyrexia; Vision blurred; Vomiting	FLU3~SANOFI PASTEUR~U1929AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0740R~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0249189	12/13/2005	NY	50.0	50		M	12/08/2005	Arm pain (injection site and gravitating to left elbow), generalized weakness, severe headache, breathing difficulty (mild wheezing), flu-like symptoms, joint pain and increased sweating, on set of symptoms, one hour to twelve hours after injection.									N	12/01/2005	12/01/2005	0		OTH	UNK	NONE		Seasonal Allergies			1						1	Arthralgia; Asthenia; Dyspnoea; Headache; Hyperhidrosis; Influenza like illness; Injection site pain; Wheezing	FLU3~SANOFI PASTEUR~U1936AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249190	12/13/2005	MD	65.0	64		F	11/28/2005	10 min post vaccine administration patient had episode of dizziness that resolved without treatment. Client returned to health dept 1 hour later with dizziness and facial flushing no other symptoms. PMD notified advised patient to go home, rest, take 1- 2 po benadryl 25 mg PRN. Spouse with patient. No symptoms at discharge approx 20 min									Y	10/26/2005	10/26/2005	0		PUB	PUB						1						1	Dizziness; Flushing	FLU3~SANOFI PASTEUR~U1904AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249191	12/13/2005	CA	38.0	37		M	11/30/2005	Within 24 hrs after rcving the flu nasal inhalant the ARGAS (sinus ARGAS) on my face had the feeling of a mild sunburn and lasted for about a week.									Y	11/14/2005	11/15/2005	1		OTH	MIL						1						1	Skin burning sensation	FLUX~UNKNOWN MANUFACTURER~~UNK~PO~MO~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0249192	12/13/2005	CA	31.0	31		F	12/09/2005	First time for flu shot. Right upper arm felt sore after injection and had pain sleeping on right arm. Next day felt pain with normal activities. Still feels tenderness at site. Still has pain with certain movements such as lifting objects.									N	11/01/2005	11/01/2005	0	UNK	OTH	PUB	UNK	NONE	UNK			1						1	Hypokinesia; Pain; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~148AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249193	12/13/2005	OR	11.0	10		F	12/01/2005	Approx 48-72 hours after flumist given developed fever to 103 degrees, lasting around 24 hours plus hives on face and back lasting around 48 plus hours -note- immunization not given here. MD saw pt vaccine obtained privately by patient and not given here.									Y	11/28/2005	11/30/2005	2		OTH	UNK						1						1	Pyrexia; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0249194	12/13/2005	WA	57.0	56		M	12/08/2005	100.6 onset 8 hours after vaccine, stomach upset first, severe chills, elbow through shoulder ache, joint pain, severe headache, muscle pain, nausea, diarrhea, stomach cramps, can't sleep, fell like may get cold.									Y	12/06/2005	12/06/2005	0		PVT	UNK	ASA;Aleve;Vit B	NONE	Hay fever			1						1	Arthralgia; Chills; Diarrhoea; Insomnia; Myalgia; Nausea; Pharyngitis; Pyrexia; Rhinitis; Shoulder pain; Stomach discomfort	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62759~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1048P~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249196	12/13/2005	IN	68.0	67		F		Chest felt tight and shallow breathing, voice tone changed when I talked, coughing to get more air in my lungs, this was 2 hours after the flu shot. The doctor gave me a Benadryl shot and it helped me breath normal again.				Y					Y	10/21/2005	10/21/2005	0		PUB	OTH	NONE	NONE	NONE	Hives~Vaccine not specified (no brand name)~1~21.00~In Patient		1						1	Chest discomfort; Cough; Dysphonia; Hypoventilation	FLU3~SANOFI PASTEUR~U1838AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249197	12/13/2005	AZ	51.0	50		F	12/05/2005	Lymphadenopathy left subclavian discovered 24 hours after injection. Site tender to touch. Ibuprofen with warm compress used to treat.  Improvement in size after one week but still tender and palpable.									Y	11/28/2005	11/29/2005	1		PVT	PVT	Zantac;Flexeril;Synthroid	NONE	NONE	swollen lymph in neck~Rubella (no brand name)~~27.00~In Patient		1						1	Lymphadenopathy; Tenderness	FLU3~SANOFI PASTEUR~U1868AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249198	12/13/2005	AZ	80.0	80		F	12/07/2005	C/O vomiting, diarrhea, abdominal cramping, body aches, right flank pain.									Y	11/16/2005	11/17/2005	1	Enteritis possible reaction to flu shot	PVT	UNK		F/U Kyphoplasty due to Fx compression	HTN;DVT;PE;Osteoporosis;Pacemaker;Knee DJD			1						1	Abdominal pain; Diarrhoea; Enteritis; Flank pain; Pain; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61501~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0249199	12/13/2005	MI	45.0	45		F	12/07/2005	Hives, hoarseness, shortness of breath, hives under arms, below eyebrows, at catheter sites for insulin pump around waist. Diagnose by nurse prac w/poison ivy!				Y					Y	10/10/2005	10/11/2005	1		PVT	UNK	Avalide;Humalog		Diabetes Mellitus Type I;Graves Disease			1						1	Dysphonia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0249200	12/13/2005	OH	1.55	1	.6	M	12/08/2005	Dtap #4 given IM right upper thigh and Polio #3 given IM right lower thigh on 11-29-05. On 11-30-05 parents reported right leg was red and swollen. No improvement through course of day with conservative tx parents took to ER 11-30-05 pm and followed up at office 12-12-05.				Y					Y	11/29/2005	11/30/2005	1	NONE	PVT	PVT	Cream for eczema from dermatologist name of med not known.	NONE	Eczema			1						1	Erythema; Oedema	DTAP~SANOFI PASTEUR~U1350AO~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1869AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0460~3~IM~RL~POLIO VIRUS, INACT. (POLIOVAX)~1	USA	Emergency room visit	Influenza
0249201	12/13/2005	VA	24.0	23		F	12/02/2005	C/O  chest tightness, throat tightness and tongue swelling while driving her car home - went straight to ER at Memorial Hospital, saw doctor.				Y					Y	12/01/2005	12/01/2005	0		OTH	PVT	Allegra;Nexium;Ortho Tri-Cyclen	NONE	NONE			1						1	Chest discomfort; Throat tightness; Tongue oedema	FLU3~SANOFI PASTEUR~U1872AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249203	12/13/2005	OK	82.0	81		F		36 hours after shot, dizziness, weakness, and high blood pressure. 12-6-05 still dizziness									N	10/24/2005	10/26/2005	2	Went to doctor week later with blood pressure high	PUB	UNK	NONE					1						1	Asthenia; Dizziness; Hypertension	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0249204	12/13/2005	IA	0.59	0	.6	F	12/08/2005	Pt given Menactra in error at 6 month visit. Pt had slight cold symptom at time of vaccine but no fever - temp. was 97.2 unable to contact mom by phone since phone disconnected, mom called office on 12-02-05 concerning sister; I explained to her what happened and she said she was a little fussy that night and cut a tooth.									Y	11/29/2005	11/29/2005	0	NONE	PVT	PUB		Cold signs and symptoms	NONE			1						1	Irritability; Medication error	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B027AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U17651A~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1723AA~1~IM~RL~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0249215	12/13/2005	LA	51.0	51		M	12/13/2005	Patient received the influenza vaccine.  Approximately 15 minutes following the vaccine administration the patient became diaphoretic, clammy, and short of breath.  He reported that his 'throat was closing' and having difficulty breathing.  Epinephrine 1:1000 was immediately administered and the patient was transported to the emergency room.    In the emergency department the patient was found to have tracheal wheezing, resp rate 28-30 bpm, and Sat of 100% on room air.  Patient had an IV started and was given diphenhydramine 25 mg IVP, famotidine 20 mg PO, methylprednisolone 125 mg IVP.  He was observed for the next 2 1/2 hours without further treatment or complaints.  He was discharged home with a Medrol dose pack.   The patient has not returned for a follow-up appointment with his primary care physician yet.				Y					Y	12/05/2005	12/05/2005	0	No laboratory test were preformed.  Pulse oximetry ranged from 98-100% on room air.	UNK	UNK	Pravachol 30 mg daily Pravacid 30 mg daily Wellbutrin XL Combivent Combivir  Viread Sustiva	None	HIV, hypertension, COPD, hyperlipidemia  No known drug allergies			1						1	Cold sweat; Dyspnoea; Hyperhidrosis; Throat tightness; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62445~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0249217	12/13/2005	CA	1.05	1	.0	F	12/13/2005	Child with two brief (1-2 minutes) generalized seizures associated with fever 104 F.				Y					Y	11/30/2005	12/09/2005	9		UNK	UNK	none	no	no			1						1	Convulsion; Pyrexia	FLU3~SANOFI PASTEUR~VI804AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0383R~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0626R~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0249218	12/13/2005	TX	15.0	14		M	12/13/2005	Fainted within 15 minutes of administration of fluzone (Aventis).  Regained conscious within one minutes but continue dizziness for 30-45 minutes after that. Uncertained of vasovagal response or adverse reaction to Fluzone.  Previous flu vaccine vaccination without any problems.									Y	12/12/2005	12/12/2005	0	BP=110/70, PR=88, RR=24	UNK	UNK	None	None	None			1						1	Dizziness; Syncope; Syncope vasovagal	FLU3~SANOFI PASTEUR~U1871BA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249219	12/13/2005	NJ	56.0	56		F	12/13/2005	Patient reports cold symptoms for 2 weeks including rhinorrhea, cough productive of white mucus, body aches, lethargy. Denies fever, but has not taken temperature.									N	11/14/2005	11/15/2005	1	None, client declined to have temperature taken by vaccine administrator.	UNK	UNK	Levoxyl	denies	thyroid disease			1						1	Cough; Lethargy; Pain; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1826AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249222	12/13/2005	CO	42.0	41		F	12/13/2005	Showed signs of illness approx. 6 hours after shot was administered on Thursday morning. She complained of pain at the site of the shot. Her mood became elevated and she was very argumentative. She later described it as being outside of herself. After very little sleep, she woke up on Friday morning with a scratchy throat and a mild headache. Feeling exhausted she slept most of the day. Saturday she woke up with no voice. She was flushed and achy. She has constant chills. Her muscles from the shot site on her right arm up through her neck were extremely tight and sore. Sunday she still had no voice. The aches and chills continued. She started feeling dizzy. Monday her voice returned although it was extremely hoarse. The dizziness worsened and she went to a doctor.				Y					U	12/08/2005	12/08/2005	0		UNK	UNK		none	none			1						1	Aggression; Chills; Dizziness; Dysphonia; Fatigue; Flushing; Headache; Injection site pain; Mood altered; Myalgia; Pain; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~05-06~1~ID~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249223	12/13/2005	PA	30.0	30		M	12/13/2005	Patient had what appeared to be a gran mal seizure that occurred without warning approximately 2 hrs after receiving the flu vaccine.  He has no prior hx of seizures, there is no family hx of seizures, and he otherwise has been in good health.  It's unclear if there is any relationship between the vaccination and the development of the seizure other than the timing.				Y					Y	12/12/2005	12/12/2005	0	Normal CT of head and basic laboratory analysis. Further work-up including MRI of brain and EEG recommended.	UNK	UNK	none	none	none			1						1	Convulsion	FLU3~SANOFI PASTEUR~U1746AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249224	12/13/2005	MO	81.0	80		F	12/13/2005	Onset 6-8 hours after flu vaccine administered, fine rash over her body. Stated her face felt like sandpaper.									Y	12/06/2005	12/06/2005	0		UNK	UNK			Stroke, breast cancer, heart ds. Severe allergy to poison ivy/oak			1						1	Rash	FLU3~SANOFI PASTEUR~U1881AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249226	12/13/2005	VA	1.01	1	.0	M	12/13/2005	Spiked fever of 103 and became very lethargic.  Would not stand up on his own, crying, and very fussy.  Very sleepy too.									Y	12/12/2005	12/13/2005	1		UNK	UNK	Prevacid	None	Acid Reflux Allergies			1						1	Crying; Irritability; Lethargy; Pyrexia; Somnolence	FLUX~UNKNOWN MANUFACTURER~~2~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~2~IM~RL~HEP B (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~2~IM~LL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249227	12/13/2005	MA	44.0	43		F	12/13/2005	Asthma Attack treated with bronchodialator.				Y					Y	11/18/2005	11/18/2005	0		UNK	UNK			Hx of Asthma in childhood			1						1	Asthma; Condition aggravated	FLU3~SANOFI PASTEUR~U1831AB~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249229	12/13/2005	NM	29.0	29		F	12/13/2005	Dizziness, 10 hours.  Headache, >24 hours.  Elbow joint pain, >24 hours. Nausea, 10 hours. Dry heaves, 3 times in 8 hours.  Pressure in nasal cavity, 6 hours.  Tingly face, 8 hours.  Loss of appetite, 24 hours. Fatigue, >24 hours.  No treatment besides lots of rest.									Y	12/12/2005	12/12/2005	0	None.	UNK	UNK	None.	None.	Seasonal allergies.  Full body rash/hives from Zithromax within the past year.  Allergic reaction to MSG, similar to this reported reaction to FluMist.			1						1	Anorexia; Arthralgia; Dizziness; Fatigue; Headache; Nasal congestion; Nausea; Paraesthesia; Retching	FLUN3~MEDIMMUNE VACCINES, INC.~500394P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0249232	12/13/2005	MI	37.0	37		F	12/13/2005	3 1/2 hours after flu vaccine, developed itchy throat, trouble swallowing feels like a golf ball in throat went to medical facility and treated for a reaction.				Y					Y	10/28/2005	10/28/2005	0		OTH	UNK						1						1	Dysphagia; Pruritus	FLU3~SANOFI PASTEUR~U1778AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249234	12/13/2005	IA	86.0	86		F	11/18/2005	Telephone call reported client had reaction to pneumonia vaccine left deltoid region that affected left arm and side of body. Redness, rash and pain. Client seen Doctor 11/15/05				Y						11/18/2005	11/18/2005	0		PUB	PVT					IA05018	1						1	Erythema; Pain; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61321~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1007P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0249236	12/13/2005	NY	1.03	1	.0	M	12/13/2005	Yesterday after child received shots; he started to cry, turned blue, seemed to stop breathing. Eyes rolled to back of head, body turned stiff, shaking occurred. Shaking lasted about 5 seconds whole episode lasted about 2 minutes. Ambulance brought child to ER; had temperature of 102 degrees F. Diagnosed there with febrile seizure.				Y					Y	12/12/2005	12/12/2005	0		PVT	PVT	NONE	Getting over cold symptoms	Amoxicillin causes rash.			1						1	Crying; Eye movement disorder; Febrile convulsion; Musculoskeletal stiffness; Pyrexia; Respiratory disorder; Tremor	FLU3~SANOFI PASTEUR~U1867CA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~VE770AA~4~IM~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0600R~UNK~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~054912~UNK~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0249237	12/13/2005	ME	52.0	52		F	12/13/2005	Soreness, burning, inability to raise arm over head consistent for approx. three weeks. Phys prescribed Flexeril and cellebrix to have x-rays 12/13/05				Y					U	11/21/2005	11/28/2005	7		PUB	PVT		NONE	NONE			1						1	Hypokinesia; Myalgia; Skin burning sensation	FLU3~SANOFI PASTEUR~U1824AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249238	12/13/2005	ME	44.0	43		F	12/13/2005	Immediate left shoulder pain, no relief. Dx rotor cuff syndrome with tendon irritation. Cortisone injection ongoing PT									N	10/26/2005	10/26/2005	0		PUB	PVT						1						1	Pain; Rotator cuff syndrome; Tendon disorder	FLU3~SANOFI PASTEUR~U1819AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249239	12/13/2005	MD	76.0	76		F	12/10/2005	12/01/05 24 hours post injection progressive increase rash started at site left arm over entire body nonpruritic nonbillform maculopapular ( arms, body, legs ) - resolved within few days no meds				Y					Y	11/29/2005	11/30/2005	1		PVT	PVT			multiple drug allergic reactions rash, upset stomach, nauseated			1						1	Rash maculo-papular	FLU3~SANOFI PASTEUR~U1856AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249261	12/13/2005	GA	0.6			U		red rash all over body									Y					PVT	PUB						1						1	Rash	DTAP~SANOFI PASTEUR~U1396DA~2~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1787BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~1013P~1~IM~RL~HIB + HEP B (COMVAX)~1|IPV~SANOFI PASTEUR~Y0343~2~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~A9440D~2~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0249231	12/14/2005	OK	41.0	41		F	12/07/2005	Took shot about 3:15pm 12/06/05. Shortly after it hit my heart and my face got hot, My chest hurt the rest of the evening with my heart beating too fast, 12/07/05 3:00pm my chest is still hurting and I did physical work at work an I started panting for breath my hands sweat, got dizzy and hot. My chest still hurts. Additonal term  from Discharge Summary rec'd 12/28/2005: vaccine reaction/sr				Y	Y	2			Y	12/06/2005	12/06/2005	0	EKG abnormal.  No additional terms in Medical Record rec'd 12/16/2005	OTH	OTH	Synthroid		Fast heart rate on occasion.			1						1	Chest pain; Dizziness; Electrocardiogram abnormal; Feeling hot; Heart rate increased; Hot flush; Hyperhidrosis; Respiratory disorder; Vaccination complication	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62755~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0249265	12/14/2005		26.0	26		F		A report was received from a healthcare professional on Dec 2 2005 concerning a 26 year old female vaccinee. The vaccinee was 16 1/2 weeks pregnant at time of vaccination. On Nov 23 2005 the vaccinee received Fluvirin intramuscularly. 4 days later, on Nov 27 2005 the vaccinee experienced a severe headache and neck stiffness. The vaccinee was directed to the ER on Dec 1 2005 where she was diagnosed with viral meningitis. The out come was not reported.										11/23/2005	11/27/2005	4		UNK	UNK	Concomitant drugs not reported.				CVOX200500231	1						1	Headache; Meningitis; Musculoskeletal stiffness; Unintended pregnancy; Viral infection	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~UNK~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0249266	12/14/2005	FL	34.0	34		F	12/14/2005	Developed symptoms by 3pm, flu like symptom, headache, myalgias, by Wednesday started vesicular rash on face, had descended down to abdomen. His back and upper thighs, C/O subjective fevers, primary symptom is itching. ER on the 8th, was given steroids, prescribed prednisone pills and they did not seem to have worked. Pt admitted on the 9th. Admission for observation and medication trial with high dose IV steroids, Tamiflu and Acyclovia. Pt discharges on the 12th.  12/20/05 Review of d/c summary indicates d/c diagnosis was chicken pox.				Y	Y	3			Y	12/05/2005	12/05/2005	0	12/20/05 Review of d/c summary indicates Varicella Zoster IgM was 1.8  high. IgG was also high. US of gallbladder showed splenomegaly. Mono screen was negative. Mild increase in LFTs noted.	OTH	UNK						1						1	Headache; Immunoglobulins increased; Influenza like illness; Liver function test abnormal; Myalgia; Pruritus; Pyrexia; Rash vesicular; Splenomegaly; Viral infection	FLU3~SANOFI PASTEUR~U1825BA~2~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0249267	12/14/2005	IL	78.0	77		F		Throughout years never had a reaction. The flu inj was not a problem but the Bolster Pneumonia in left arm was crucible occurring just less then 24 hours, arm swelled to 3 times size, heat was radiating and rigor of both arm where couldn't grasp a phone to call Doctor. As per annual follow up report: clinical indication Bacteremia and sepsis, cellulitis, left shoulder. Fever, chills, shaking, pain, nausea.			Y	Y	Y	5			U	11/04/2005	11/05/2005	1	Poisonous toxin, Elevated enzymes liver count.  As per annual follow up report: see all attached forms reflecting it was definitely toxin.	PVT	UNK						1						1	Bacterial infection; Cellulitis; Chills; Drug toxicity; Feeling hot; Hepatic enzyme abnormal; Injection site reaction; Nausea; Oedema; Pain; Pyrexia; Sepsis; Tremor	FLU3~SANOFI PASTEUR~U1802BA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0607R~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0249268	12/14/2005	CA	78.0	77		M	12/11/2005	Patient received a flu vaccine on 10/08/05. he then developed a cough, malaise and angioedema. He was admitted on 11/07/05 with nephritis. Biopsy on 11/30/05 showed necrotizing glomerulonephritis. Additional terms added from Dischare Summary rec'd 12/28/2005: Headacne, tachy. CHF, kidney failure, dec. urine output,  inc. creatinine/sr Discharge summary states drug reaction. msv Per 60 day folow up report-Patient died of end stage renal disease with multi-organ failure.	Y				Y				N	10/05/2005	10/06/2005	1	Kidney biopsy showed necrotizing glomerulonephritis.	OTH	PVT	NONE	NONE				1						1	Angioneurotic oedema; Blood creatinine increased; Cardiac failure congestive; Cough; Drug toxicity; Glomerulonephritis; Headache; Malaise; Multi-organ failure; Nephritis; Oliguria; Renal failure; Renal failure chronic; Tachycardia	FLU3~SANOFI PASTEUR~U1808AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0249269	12/14/2005	KY	1.01	1	.0	M	12/12/2005	Within 10 min of receiving vaccines, child became unresponsive to mom, eyes rolled back, muscle tone decreased, BP 82/48, P 100, R 26 x easy, non reactive to stimuli. Epinephrine 1:1000 .1cc given SUBQ. Child became more responsive, recovered 35-45 min.				Y					Y	12/12/2005	12/12/2005	0	EEG to be done	PVT	PUB		Sinusitis	Eczema			1						1	Coma; Eye movement disorder; Hypotonia	FLU3~SANOFI PASTEUR~U1914AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~1014P~3~IM~LL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0383R~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0414R~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0249270	12/14/2005	PA	62.0	61		M	12/08/2005	About a week 4-6 days later client developed a rash with raised pimple like papules and spontaneous bruises under arms with extreme itchiness.									Y	10/18/2005	10/23/2005	5	Blood work by physician.	OTH	OTH	Altace, Isosorbide, Lipitor, Allopurinol, Toprol.	NONE	High blood Pressure, arthritis.			1						1	Acne; Contusion; Pruritus; Rash; Rash maculo-papular; Rash papular	FLU3~SANOFI PASTEUR~U1777AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249283	12/14/2005	MI	54.0	54		F	12/14/2005	Dec 2nd- Ear pain Lt side sharp & deep, blurred vision- Eye won't close, tearing, mouth drooped to side Lt nostril constanly running, muscle twitches under eye and above lip, difficulty chewing & swallowing. Dec 4th E.R. visit Medical records state paresthesia, facial paralysis. msv				Y					Y	11/08/2005	12/04/2005	26	CAT scan Bloodwork Medical records state leukocytosis, abnormal lab tests. msv	UNK	UNK	Lipitor Zesteretic	none	Blood Pressure elevated Cholesterol Medical records state tenosynovitis. msv			1						1	Dysphagia; Ear pain; Eye disorder; Facial palsy; Laboratory test abnormal; Leukocytosis; Muscle twitching; Paraesthesia; Vision blurred	FLU3~SANOFI PASTEUR~U1833BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249284	12/14/2005	KY	56.0	56		U	12/14/2005	recieved vaccination at 1:00 pm 12/12/05, at work,then went to break @ 2:00 pm and started having chest pains really bad, this i thought was from having a hiatel hernia. then at 5:00 i went to lunch and had a sore throat and started coughing and could not stop,then within 30 minutes i started getting real dizzy, and then i got the chills so bad i had to leave work, when i got home i took my temp. and it was 101.7. this was around 7:00 pm. my fiance had a prescription for tamiflu and i started taking this. The next morning my fever had broke and was back to normal. I just had the aches and pains and felt lousy the rest of the day and slept pretty much the whole day. I have had to miss 2 days work because of this.									Y	12/12/2005				UNK	UNK		none				1						1	Chest pain; Chills; Cough; Dizziness; Hiatus hernia; Pharyngolaryngeal pain	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0249285	12/14/2005	NC	32.0	32		M	12/14/2005	Flu vaccine given at 8:30 am. client developed shortness of breath and back pain around 11 am.Took Advil for relief and soon developed lip swelling and itchy mouth. Went to local ER and was given Benadryl and ibuprofen.Sent home on Prenisone by mouth for 4 days.				Y					Y	12/13/2005	12/13/2005	0		PUB	PUB	Advil					1						1	Back pain; Dyspnoea; Face oedema; Pruritus	FLU3~SANOFI PASTEUR~U1846AA~1~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249287	12/14/2005	NJ	59.0			F	12/14/2005	Onset of right sided Bell's palsey 12 hours post injection.  The patient has tolerated IM flu injections very well in each of the past 10 years.				Y					Y	11/03/2005	11/04/2005	1	Treatment with IM steroids. Complete resolution in 48 hours.	UNK	PVT	None	None	None			1						1	Facial palsy	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA138BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0249290	12/14/2005	WI	52.0	52		F	12/14/2005	Pt developed rash at injection site 3-4 days after administration.									Y	10/14/2005	10/21/2005	7		UNK	UNK	Thyroid 50mcg.,Hctz 50mg.	none	hypothroidism, hypertension			1						1	Injection site rash	FLU3~SANOFI PASTEUR~U1744AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249291	12/14/2005	NY	3.0	2	.5	F	12/14/2005	Presenting symptoms included: mental status changes; regression of developmental milestones; ataxic gait; incoordination; seizures; loss of speech; inability to eat; meningial signs; tremor; irritability. Above mentioned symptoms appeared acutely on 12/1/05. Pt. is still in the hospital, already two weeks. A clear diagnosis has not been established, working diagnosis is post-infection/post-vaccine encephilitis.Treatments included: empiric antibiotics started and discontinued, acyclovir continued for 14 days, IVIG. Patient is improving. Discharge summary states viral infection. msv				Y	Y		Y		U	11/22/2005	12/01/2005	9	Discharge summary states EEG abnormal. msv	UNK	UNK		None	None			1						1	Aphasia; Convulsion; Coordination abnormal; Electroencephalogram abnormal; Encephalitis; Irritability; Meningism; Mental impairment; Neurodevelopmental disorder; Oral intake reduced; Tremor; Viral infection	FLU3~SANOFI PASTEUR~1788BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0249293	12/14/2005	GA	84.0	83		M	12/14/2005	~ 2 wks after vaccine he became weak, next day he collapsed, was taken to ER , was admitted to hospital. Spouse said diagnosis was Guillian-Barre. After a lengthy stay in the hospital, he has been moved to a long term care facility. Information from discharge summary states apnea, pneumonia, urinary tract infection. msv Medical records state dysphagia. msv			Y	Y	Y		Y		U	10/10/2005			Medical records state normal lab test, hyperglycemia. msv	UNK	UNK	flomax 0.4 altace 5	no	Discharge summary states leukemia, diabetes mellatis, hypertension.msv Medical records state abnormal gait. msv			1						1	Apnoea; Asthenia; Dysphagia; Guillain-Barre syndrome; Hyperglycaemia; Laboratory test abnormal; Pneumonia; Syncope; Urinary tract infection	FLU3~SANOFI PASTEUR~U1778AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0249294	12/14/2005	MS	64.0	63		F	12/14/2005	Large inflammatory area 4-5 cm in diameter that resulted in decreased ability to raise left arm that appeared within 24 hrs of injection no s/s infection but area was very large an warm to touch.				Y					Y	12/05/2005	12/05/2005	0		UNK	UNK						1						1	Hypokinesia; Injection site inflammation; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62013~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1039P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0249296	12/14/2005	AZ	20.0	20		F	12/14/2005	NAUSEA, CLAMMY PALE SKIN, LOW BLOOD PRESSURE. SLIGHT DIFFICULTY BREATHING EMERGENCY PERSONEL ARRIVED AND TREATED PATIENT FOR AN ALLERGIC REACTION.  EMERGENCY PERSONEL SAID THAT PATIENT WAS HAVING A REACTION, BUT NOT SURE IF IT WAS AN ALLERGIC REACTION.				Y					U	12/14/2005	12/14/2005	0		UNK	UNK						1						1	Blood pressure decreased; Cold sweat; Dyspnoea; Nausea; Pallor	FLU3~SANOFI PASTEUR~U1805AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249298	12/15/2005	CA	0.0			U	12/15/2005	I got a rash on my arms and legs for several days. They would go away as I slept and in the daytime and return in the evenings.									Y					UNK	UNK						1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0249299	12/15/2005	MD	11.0	11		F	12/15/2005	Itching on both arms and hives to arms.				Y					Y	12/14/2005	12/14/2005	0	Possible allergic reaction to flu shot.	MIL	MIL	none	none	none			1						1	Hypersensitivity; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1872AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249300	12/15/2005	MS	64.0	64		M	12/01/2005	24 HRS PAST GETTING FLU SHOT PATIENT C/O BEING DIZZY, HAD LOW GRADE FEVER & RUNNY NOSE X 1 DAY.  DIARRHEA X 6-8 HOURS.									Y	11/14/2005	11/15/2005	1	NONE	UNK	UNK					MS0525	1						1	Diarrhoea; Dizziness; Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1015AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249301	12/15/2005	OK	37.0	37		F	12/15/2005	Immediately after shot, arm began to get sore.  Soreness has continued to increase in severity.  Arm is swollen. Pt can not move arm above shoulder level.									U	10/25/2005	10/25/2005	0		UNK	UNK			Asthma, blood in urine, possible bladder cancer, migraines			1						1	Hypokinesia; Joint range of motion decreased; Pain; Swelling	FLU3~SANOFI PASTEUR~U1861AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249302	12/15/2005	PA	57.0	56		F	12/15/2005	Within 4 hour of 3:15pm injection: severe sore throat, inflammation and redness of mucosa under my tongue, and feelings of tongue slightly swollen, fever of 100 degrees, eyes tearing throughout the night.  sll symptoms were gone within about 20 hours except for slight swelling and redness under my tongue.									Y	12/13/2005	12/13/2005	0	NA	UNK	UNK	None	None	None			1						1	Erythema; Lacrimation increased; Mucosal inflammation; Pharyngolaryngeal pain; Pyrexia; Tongue oedema	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0249303	12/15/2005	MT	0.97	0	1	F	12/15/2005	Seizure, febrile.				Y					Y	12/14/2005	12/14/2005	0		UNK	UNK	Tylenol	URI which progressed to bronchiolitis after the vaccine given	None			1						1	Convulsion	FLU3~SANOFI PASTEUR~U1765HA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249306	12/15/2005	MS	35.0	35		F	12/09/2005	PT STATES:  AFTER FLU SHOT MY BODY WAS WEAK AND I WAS DRAGGING FOR 2 DAYS'. 12/9/2005 PT WENT FOR SONOGRAM M D AND FOUND NO HEARTBEAT OF FETUS.									Y	11/29/2005	12/09/2005	10		UNK	UNK		MORNING SICKNESS	5-6 WEEKS PREGNANT		MS05027	1						1	Abortion spontaneous; Asthenia	FLU3~SANOFI PASTEUR~U1806AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249307	12/15/2005	MS	59.0	58		F	11/17/2005	PT COMPLAIN OF FEELING BAD THE DAY OF THE VACINE. NECK GOT STIFF AND HURT. WHEN HELD HEAD BACK SHE HAD PAIN. ALSO HAD HEADACHES AND NAUSEA. DENIES FEVER. ENERGY LEVEL DROPPED ON 10/22/05. CONTINUED WITH ENERGY DECREASE. FATIGUE AND STIFF NECK WORSENED. LASTED ABOUT 2 WEEKS.									Y	10/20/2005	10/21/2005	1	NONE	UNK	UNK		NONE			MS05028	1						1	Asthenia; Fatigue; Feeling abnormal; Headache; Musculoskeletal stiffness; Nausea; Neck pain	FLU3~SANOFI PASTEUR~71839AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249308	12/15/2005	MO	61.0	61		F	11/10/2005	11/4 Reported 5 p.m. fever 102 degreees F continued through night. 7 p.m. felt achy, could barely move especially through ribcage abdominal very painful. 11/5 7 a.m. fever 100 degrees F. Started feeling better in the afternoon. Called Health Department 11/9. Still complaining of sore intestines and severe constipation. Did not seek medical attention. 11/10 states feels good today.									Y	11/02/2005	11/04/2005	2	none	UNK	UNK	BUPROPION 50 MG @ BEDTIME, ONE A DAY VITAMIN	NONE	MITRAL VALVE PROLAPSE		MO2005043	1						1	Abdominal pain; Constipation; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1830AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249310	12/15/2005	MO	1.15	1	.1	M	11/10/2005	CLIENT BEHIND ON VACCINE SCHEDULE. GIVEN PEDIARIX AND IPV SAME DAY INADVERTENLY.										11/03/2005				UNK	UNK					MO2005041	1						1	Medication error	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~ACZ1A02AA~5~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~APU1863AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0481R~2~IM~LL~HIB (PEDVAXHIB)~1|IPV~SANOFI PASTEUR~APX1240-2~2~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0131R~1~IM~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A25964K~2~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1113P~1~IM~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0249311	12/15/2005	CA	19.0	19		F	12/15/2005	Congestion, headache across forehead, sinus swelling and blurred vision. CT scan, eye exam and 2 liters normal saline.				Y					Y	12/10/2005	12/11/2005	1	CT scan and eye exam	MIL	MIL	None	None	Allergy to amoxicillin and Strabisimus (verticle)			1						1	Headache; Nasal congestion; Swelling; Vision blurred	FLUN3~MEDIMMUNE VACCINES, INC.~500387~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0249312	12/15/2005	WI	75.0	74		F	12/15/2005	Developed marked dyspnea on exertion with SOB at rest and occasional cough productive of red sputum.  Condition deteriorated despite intervention. Additional terms added from Discharge Summaries rec'd 12/28/2005: Hypoxia, lab test abnorm, leukocytosis, Inc. BP, Hyperglycemia, atrial fib, anemia, dyrhythmia, resp failure, cardiomegaly, pneumothorax, ileus, broncholitis, pneumonia/sr	Y	12/02/2005			Y	27			N	11/02/2005	11/04/2005	2	ABG, CBC, chemistry, lung biopsy	UNK	UNK	synthroid 75 mcg qd; lopressor 200 mg BID; lasix 40 mg daily; norvasc 5 mg daily; pulmicort inhaler BID	non-productive cough, nasal drainage, afebrile	HPD, hypothyroidism, anxiety, reflux disease, S/P laryngeal cancer			1						1	Anaemia; Arrhythmia; Blood pressure increased; Bronchiolitis; Cardiomegaly; Cough; Dyspnoea; Hyperglycaemia; Hypoxia; Ileus; Laboratory test abnormal; Leukocytosis; Pneumonia; Pneumothorax; Respiratory failure	FLU3~SANOFI PASTEUR~U1802FA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0249313	12/15/2005	CA	36.0	36		M	12/15/2005	Passed out. SPO2 100% water intake 3 cups.									Y	12/10/2005	12/10/2005	0	None	MIL	MIL	None	None	None			1						1	Loss of consciousness	FLUN3~MEDIMMUNE VACCINES, INC.~500387~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0249314	12/15/2005	IL	69.0	68		F	12/15/2005	101 fever, rt arm swollen, red from shoulder to elbow within 8 hours....of recieving shot.  12/15 swelling went down into wrist area.  temperature gone still red/swollen. Called VNA-TIP on 12/14 left message this director was told that she took tylenol and contacted physician.  He was heading out of town she called us to inform of situation.  I advised her to apply ice to the area take tylenol and to let me know how things are overnight. She called me back mid morning said her pharmacist looked at her arm and suggested she go to the emergency room...I asked this patient to let me know how things go.				Y					U	12/13/2005	12/13/2005	0	Unknown	UNK	UNK	Unknown	Unknown	Unknown			1						1	Erythema; Pyrexia; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62107~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1038p~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0249315	12/15/2005	OH	5.0	4		F	12/15/2005	Patient vomitted, had diarrhea,and then fainted-- became very pale, then whole face including ears bright red except all area around mouth was white, arms also red, chest white, Then splotches almost like hives  All she wanted to do was sleep even though it was 11:00 A.M. after a good nights rest.  This began immediately after receiving the 4 shots.  Patient stayed in doctors office for about 3 hours to be watched carefully.  She wanted to sleep entire time after fainting.  She never got upset when she received the shots.  Doctor said it was definately a reaction but she has never seen such an immediate reaction.									Y	11/10/2005	11/10/2005	0	Doctors checked blood pressure and her breathing.  They were fine.	UNK	UNK		no				1						1	Diarrhoea; Erythema; Pallor; Syncope; Urticaria; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~UN~DTAP + HEPB + IPV (PEDIARIX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~~GM~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1	USA		Influenza
0249318	12/15/2005		67.0	67		F	12/13/2005	Information has been received from a registered nurse concerning a 67 year old female with high blood pressure who on Nov 21 2005 was vaccinated IM into the right arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 651330/1048P). On Nov 21 2005, the patient was also vaccinated in the left arm with a dose of influenza virus vaccine (unspecified). Concomitant therapy included sertraline HCL (Zoloft), hydrochlorothiazide (+) valsartan (Diovan HCT) and verapamil HCL (Veralan). On Nov 21 2005 the patient developed shortness of breath, shooting pain in her right arm, shaking of her head and body, dryness of mucus membranes, nausea, diarrhea, fatigue, cellulitis and she felt flushed. From her right deltoid to her elbow she developed cellulitis with swelling, tenderness and axillary pain. The patient was treated with cephalexin (Keflex) and acetaminophen (+) hydrocodone bitartrate (Vicodin). The patient was reported as recovered. Shortness of breath, shooting pain in her right arm, shaking of her head and body, feeling flushed, dryness of mucus membranes, nausea, diarrhea, fatigue and cellulitis were considered to be disabling and other important medical events by the reporting nurse (OMIC). There was no product quality complaint involved. Additional information has been requested.								Y	Y	11/21/2005	11/21/2005	0		OTH	OTH	Diovan HCT, Zoloft, Veralan		Blood pressure high		WAES0512USA00738	1						1	Cellulitis; Diarrhoea; Dry skin; Dyspnoea; Fatigue; Flushing; Mucous membrane disorder; Nausea; Oedema; Pain; Tenderness; Tremor	FLU3~SANOFI PASTEUR~UNK~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1048P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0249329	12/15/2005	IL	16.0	16		F	12/14/2005	NONE, Flu vaccine given today, and pt had flu vaccine 12/05/2005.										12/14/2005			NONE	OTH	UNK	Depakote, Flonase, Zoloft, Albuterol, Seroquel,	Resolving abdominal pain.	Fish (throat swelling), Pears (H/O rash).			1						1	Medication error	FLUX~UNKNOWN MANUFACTURER~U1881AA~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~MERCK & CO. INC.~0187R~3~IM~LA~HEP A (VAQTA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52600~1~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0249331	12/15/2005	GA	41.0	40		F	12/15/2005	Within 10-12 hours post flu mist, pt noted onset of nasal congestion, headaches, body aches and nausea. Symptoms have not subsided and continue today. Also reports sinus congestion, dry cough, and decreased appetite. Stated nasal drainage is clear and denies any problems with seasonal allergies. has seen a provider and was treated with Cefzil, Flonase and Maxiphed, with no improvement. Was also given a Z pack. pt is concerned about feeling ill for so long. Nasal drainage start 11/09/2005, headache, general started 11/09/2005, Flu like symptoms 96 hours start 11/09/2005, nausea w/o vomiting start 11/09/2005.				Y						11/08/2005	11/09/2005	1		MIL	MIL						1						1	Cough; Decreased appetite; Headache; Influenza like illness; Malaise; Nasal congestion; Nausea; Pain; Rhinorrhoea; Sinus congestion	FLUN3~MEDIMMUNE VACCINES, INC.~500388P~1~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0249332	12/15/2005	MN	64.0	63		F	12/02/2005	Arm red and painful -9 (1-10).				Y					Y	11/21/2005	11/21/2005	0		PVT	PVT			Hypertension, Aortic valve replaced.			1						1	Erythema; Pain	FLU3~SANOFI PASTEUR~U193AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0746P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0249334	12/15/2005	MI	3.0	2	.7	F		Started small bump on knuckles then arms and legs, itchy. No fever lasting 3-4 days, left small dark areas on skin. Mother do not report to office until 12/13/2005.									Y	11/08/2005	11/10/2005	2		PVT	UNK	Takes multi vitamin.	NONE	Umbilical hernia.			1						1	Pruritus; Rash; Skin discolouration	FLU3~SANOFI PASTEUR~U1765FA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249335	12/15/2005	NJ	5.0	4		F	12/15/2005	None Stated.									Y	12/12/2005	12/14/2005	2		PVT	UNK						1						1	Unevaluable event	DTAP~SANOFI PASTEUR~U1396CA~5~~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1914AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249336	12/15/2005	MA	1.39	1	.4	M	12/15/2005	Rash 2 weeks after vaccine.									Y	12/05/2005	12/15/2005	10		PVT	PUB		NONE				1						1	Rash	DTAP~SANOFI PASTEUR~U1396CA~4~~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1747AA~UNK~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~~4~~LL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0467R~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0249337	12/15/2005	MD	1.02	1	.0	F	12/12/2005	Ran a fever of 103 four days after being vaccinated.				Y					Y	12/08/2005	12/10/2005	2	Ran a throat culture.	PVT	PVT	NONE	NONE	NONE			1						1	Pyrexia	FLU3~SANOFI PASTEUR~U1746AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1299N~1~IM~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A944400~3~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0656P~1~IM~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0249338	12/15/2005	VA	62.0	62		M	12/09/2005	Pt received flu vaccine on 12/02/2005. Pt called MD on 12/09/2005 and stated he broke out in welts on arm and chest on 12/07/2005 then more appeared on legs 12/08/2005. No itchiness. Referred to PMD pt agreeable to f/u with PMD.									U	12/02/2005	12/07/2005	5		PVT	UNK	Plavix, Anti hypertension, antilipidemic.		Hypertension, Heart attack, high cholesterol.			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1872AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249339	12/15/2005		29.0	29		M	11/17/2005	Pt with development of varicella following vaccination.									U	10/24/2005	11/08/2005	15	None	MIL	MIL	Pamelor, Doxycycline.	NONE	NONE			1						1	Viral infection	FLU3~SANOFI PASTEUR~U1839AA~7+~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0433P~1~~RA~HEP B (RECOMBIVAX HB)~1|VARCEL~MERCK & CO. INC.~0893P~1~~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0249340	12/15/2005	LA	89.0	89		F	11/30/2005	Slight swelling and severe redness to left arm from sight of injection in deltoid muscle to elbow. This was observed by family 2 days after injection. Reaction began clearing up by 5-6 days after injection. No sign of redness or swelling 7 days after injection.									Y	11/21/2005	11/23/2005	2		PUB	PUB	Lasix;Arecept;Nexium;Lotrel;Lexapro;ASA;Clortom	NONE	PCN;HTN;Non Hodgkins Lymphoma		UA05T205	1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U1917AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249341	12/15/2005	MI	46.0	45		F	11/28/2005	Approximately 1 hr after receiving flu vaccine client began to experience chest tightness accompanied by cough. She fell asleep approximately 4 hrs after receiving the vaccine, still coughing with chest tightness. When she woke up 1 hr later her symptoms were gone and she felt better. No further symptoms have been experienced.									Y	11/21/2005	11/21/2005	0	NONE	PUB	UNK	St Joh's Wort;OTC Vitamins;Iron	NONE	Iron Deficiency Anemia		M12005042	1						1	Chest discomfort; Cough	FLU3~SANOFI PASTEUR~U1935AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247295	12/16/2005	MD	48.0	48		F	12/13/2005	Initial report received from a health care professional on 08/Dec/2005. A 48 year old female patient received an intra-muscular dose of Fluzone SV 2004-2005 USP, lot number U1863AA, in the left deltoid on 11/Nov/2005 at 2:00 pm. Three hours later, she felt swelling in her throat and noticed that her eyes were puffy. She did not experience any itching or difficulty breathing. The patient was seen by a physician and was treated with Zantac. The symptoms resolved one hour after treatment.				Y					Y	11/11/2005	11/11/2005	0		OTH	PVT	Calcium;Vitamin D;Zoloft		The patient has a history of allergies to Sulfa, Demerol and toluene. She has no history of adverse events following prior vaccination, and had previously received three doses of influenza vaccine. She had no reported illnesses at the time of vaccination.		200502736	1						3	Cough; Dysphagia; Eye discharge; Headache; Lethargy; Ocular hyperaemia; Throat tightness; Pharyngeal oedema; Eye swelling; Pharyngeal oedema	FLUX~UNKNOWN MANUFACTURER~~3~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1863AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~U1863AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Emergency room visit	Influenza
0247440	12/16/2005	OH	18.0			M	12/13/2005	Initial report received from the Centers for Disease Control and Prevention (VAERS numbers 247539 and 247440) on 22/Nov/2005. An 18 year old male patient received a dose of Menactra, lot number U1821AA, in the right arm and a dose of Fluzone SV 2005-2005 USP in the right arm on 29/Oct/2005 at 11:00 am. Eight days later the patient experienced chills, body aches, headache, fever and trouble urinating. The following day he had difficulty walking (also reported as inability to walk balanced). He was seen in the emergency room and also complained of a cold and tingling sensation in his feet and legs. A catheter was inserted and the patient was prescribed antibiotics. On 09/Nov/2005, the patient had much difficulty walking and fell over. He returned to the emergency room and was transferred to a clinic. He was treated with ceftriaxone and Acyclovir. The admission note state that the impression was probably ADE (acute disseminated encephalopathy) likely secondary to Menactra. The patient had a high cervical sensory level and bilateral pyramidal signs. He had an abnormal MRI, which showed bilateral patchy white matter signals. The patient's recovery status is unknown. This information had previously been submitted to the FDA. Follow-up information received on 30/Nov/2005 from the Centers for Disease Control and Prevention. Admission date to the hospital was 09/Nov/20052. The patient was transferred for rehabilitation on 15/Nov/2005. At that time, a lack of sensation below the shoulder remained. At the time of this report, the patient had not recovered. Follow-up information received on 08/Dec/2005 from the consulting neurologist. It was reported that the patient had a viral upper respiratory infection about two weeks prior to his admission to the hospital. Following the onset of the reported symptoms of ADEM. he was admitted to the hospital on 09/Nov/205. The principal diagnosis was acute disseminating encephalopathy.  A lumbar puncture on 10/Nov/2005 showed a red blood cell count of 13, white blood cell count of 99, protein 84, glucose 99, elevated IgG 8.4, albumin 58.1. A gram stain was negative and culture of the CSF showed no growth. PCR for herpes simplex was negative. Empiric therapy of Acyclovir and ceftriaxone were started upon admission, but were discontinued upon receiving the laboratory work. The patient was treated with a four day course of IV Solu-Medrol, which resulted in a clinical and neurological improvement. Physical and occupational therapies were also initiated,and it was noted that the patient had good progression of retaining lower extremity strength. An ophthalmologic examination confirmed that the retinal and optic nerves were not involved. On 14/Nov/2005, the IV Solu-Medrol was discontinued and oral prednisone therapy was begun. The patient continued to require physical and occupational therapy to regain strength and control. He was, however, stooling and voiding spontaneously. On 15/Nov/2005, the patient was transferred to a rehabilitation hospital in good condition.				Y	Y	7			N	10/29/2005	11/07/2005	9	10/Nov/2005 lumbar puncture - red blood cell count of 13, white blood cell count of 99;protein 84;glucose 99;elevated IgG 8.4;albumin 58.1;A gram stain was negative, and culture of the CSF showed no growth. Herpes simplex PCR - negative	PVT	PVT			The patient has a history of amoxicillin allergy. From information received on 08/Dec/2005, it was reported that the patient had a viral upper respiratory infection about two weeks prior to his admission to the hospital		200502548	1						3	Chills; Difficulty in walking; Dysphemia; Dysuria; Nuclear magnetic resonance imaging; Balance disorder; Dysuria; Fall; Gait disturbance; Headache; Hypokinesia; Pain; Paraesthesia; Peripheral coldness; Pyrexia; Balance disorder; Chills; Difficulty in walking; Dysuria; Encephalopathy; Headache; Immunoglobulins increased; Pain; Paraesthesia; Peripheral coldness; Pyrexia; Sensory disturbance	MNQ~SANOFI PASTEUR~~UNK~~~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|FLU3~SANOFI PASTEUR~U1815AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|MNQ~SANOFI PASTEUR~U1821AA~UNK~~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|FLU3~SANOFI PASTEUR~U1815AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|MNQ~SANOFI PASTEUR~U1821AA~UNK~~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~3	USA	Hospitalisation	Influenza
0249328	12/16/2005	DC	77.0	77		F	11/18/2005	The vaccine was given Thursday, 10/13/2005 about 12:00pm. Friday 10/14/05 I was cold and sluggish all day. About 6:00pm I went to bed and did not wake until Sat 10/15/05 about 9:00am. I woke up with a headache, my entire body was aching, muscles, joints, fingers, feet, shoulders. I could hardly get out of bed, I was bent over as I moved slowly to the bathroom. Chills were running up and down my muscles. The arms, hands and wrist were so swollen I could not make a fist, wring water out of my bath cloth or dish cloth, neither could I turn on my shower. When I moved my bones made loud cracking sounds. Pain to move my neck. My gums were sore and aching event though teeth had been pulled out years ago. Elbow ached, made cracking sounds. I would wake up about 5:00am with aching fingers, wrist, joints. Feet were aching, the toenail on right foot was split down the middle. Right eyelid is dropping (noticeable). Lumps or swelling are under the skin in my arms and hands. I had to take one step at at time, could not squat. Had difficulty getting out of bed. Weakness in my knees.				Y					N	10/13/2005	10/14/2005	1	1st blood test abnormal and 2nd blood test indicated Lupus.	PVT	UNK	Sular, Zocor, HCTZ, Calcium, Vitamin	NONE	Pollen, Dust mold, aspirin.			1						1	Arthralgia; Asthenia; Bone disorder; Chills; Eye disorder; Feeling cold; Headache; Hypokinesia; Laboratory test abnormal; Nail disorder; Neck pain; Oedema; Oedema peripheral; Pain; Sluggishness; Stomatitis; Systemic lupus erythematosus	FLU3~SANOFI PASTEUR~U1804AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249365	12/16/2005	NY	48.0	48		F	12/14/2005	Initial report received from a health care provider on 12/Oct/2005. A 48 year old female patient with a pre-existing medical history reported as no egg allergies, had been hospitalized for unspecified reasons, and received an injection of Fluzone SV 2005-2006, lot number unknown; and Pneumovax, manufacturer lot number unknown, at the time of hospital discharge on 05/Oct/2005. The sites and routes of vaccination were unknown. Five days later, she developed a scattered pinpoint rash on her torso that became generalized over her entire body. The patient had no illness at the time of vaccination, and information regarding other medications was unknown. The patient was examined in the emergency room and treated with steroids and Benadryl. Per the reporter, the patient returned to the emergency room 12 hours later and received the same treatment. The patient was examined during an office visit on 12/Oct/2005, and the symptoms had resolved. The patient was not hospitalized for these events. At the time of this report, the patient had recovered. Follow-up information received on 28/Nov/2005 from a health care professional. It was reported that the patient had been hospitalized due to a possible vascular occlusion of the third right finger prior to receiving the vaccine on 05/Oct/2005. An angiogram at the time of hospitalization was negative. The patient had not received any influenza vaccines in the past. Following the event of generalized rash on 10/Oct/2005, the patient improved and the reaction had mostly resolved at the time of this report (it was previously reported that the patient had recovered). No other information was provided at this time. Follow-up information received on 07/Dec/2005 from another company (reference number WAES0510USA06778). It was reported that the Fluzone SV 2005-2006 and the Pneumovax vaccinations were administered in opposite arms, but no specific site was reported. Following the onset of the events on 10/Oct/2005, the patient was seen in an emergency room twice on the same day. On the first visit she was treated with oral prednisone and diphenhydramine hydrochloride (Benadryl). During the second emergency room visit, she was treated with IV steroids and diphenhydramine hydrochloride (Benadryl)., and was placed on oral prednisone. It was noted that the patient experienced a local site reaction of the arm, but it was not reported whether the reaction occurred at the site of the Fluzone SV 2005-2006 or Pneumovax injection. The patient was seen by the physician on 12/Oct/2005 and the symptoms had resolved at that time. The reporter noted that the patient was not hospitalized for the events. At the time of this report, the patient had recovered. The reporting physician considered the diffused rash and local site reaction of the arm to be disabling and other important medical events. Based upon this new information, this case is being upgraded to serious.				Y				Y	Y	10/05/2005	10/10/2005	5		PVT	UNK			The patient had no illness at the time of vaccination, and information regarding other medications was unknown. Per the reporter, the patient had no egg allergies. No other medical conditions were reported. Prior to receiving the vaccine on 05/Oct/2005, the patient had been hospitalized for unspecified events. From additional information received on 28/Nov/2005, it was reported that the patient had been hospitalized due to a possible vascular occlusion of the third right finger prior to receiving the vaccine on 05/Oct/2005. An angiogram at the time of hospitalization was negative. The patient had not received any influenza vaccines in the past. From additional information received on 07/Dec/2005, it was reported that the patient's past medical history also included hay fever.		200502082	1						1	Injection site reaction; Rash	FLU3~SANOFI PASTEUR~~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0249369	12/16/2005	TX	41.0	40		F	12/12/2005	Initial report received on 07/Dec/2005 from a health care professional. A 40 year old female with no significant medical history, had received an intra-muscular injection of Fluzone SV '2005-'2006 USP, lot number U1775AA, in the right deltoid and an intra-dermal injection of TUBERSOL 5 TU, lot number C2079AA, in the right arm on 07/Dec/2005. Fifteen minutes later, the patient had a large red area at the injection site (side was not identified), difficulty breathing, chest tightness and weakness in her legs. She was transferred in a wheel chair to the nurse office and was given oxygen. An electrocardiogram was done and she was transferred to the hospital. It is unknown if the patient recovered from these events at the time of this report.				Y					U	12/07/2005	12/07/2005	0		UNK	UNK	Tubersol				200502731	1						1	Asthenia; Chest discomfort; Dyspnoea; Injection site erythema; Injection site reaction	FLU3~SANOFI PASTEUR~U1775AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249371	12/16/2005	MN	48.0	48		F	12/05/2005	About 2-3 days after receiving flu shot, started to develop weakness and tingling in arm. Then began to have cramping sharp pain in different parts of the arm and on admission (hospital) was experiencing chronic headache, neck pain, shooting pain in arm from shoulder into forearm associated with weakness and loss of feeling. Ears plugged, throat dry. Is recovering somewhat according to recent report. Discharge summary states pain in arm, fatigue, hypotension. msv Per 60 day follow up report-Patient states she is about 85% recovered. Occassionally experiences a spasm when lifting a heavy object or when bending arm back to put on a coat which causes a feeling of weakness from neck to elbow. Back to work at a .7 fte which is what she was working before the incident. Patient states that she goes to physical therapy about twice a month now compared to 4 times weekly just after the incident. 02/02/07 Stated to me that about twice each month she gets weakness in her left upper arm and pain that radiates into her neck on the left side accompanied by a migraine headache.				Y	Y	4			N	11/08/2005	11/11/2005	3		PVT	PVT	Mirapex;Premarin;Lexapro					1						1	Asthenia; Dry throat; Ear discomfort; Fatigue; Flat affect; Headache; Hypotension; Muscle spasms; Muscle spasms; Neck pain; Pain; Pain; Pain in extremity; Paraesthesia	FLU3~SANOFI PASTEUR~U1802DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0249372	12/16/2005	CA	5.0	4		F	12/09/2005	Right arm swelling 5x5, itchy and red. Ice pack with Tylenol.									Y	12/07/2005	12/08/2005	1		PVT	PVT	NONE					1						1	Erythema; Oedema; Pruritus	DTAP~SANOFI PASTEUR~C2220AA~5~~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1863AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0326~4~~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0301R~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0249373	12/16/2005	PA	82.0	81		M	12/12/2005	At 6pm the day vaccine was administered, patient developed chills (no temperature was taken) and achiness. The following day the patient still did not feel well with chills and achiness. He remained at rest the entire day. By 11/25 symptoms completely resolved.									Y	11/23/2005	11/23/2005	0	NONE	PUB	PVT	Zocor, Unknown medication for tremors.	NONE	Chronic bronchitis, essential tremor, hypercholesterolemia.			1						1	Chills; Malaise; Pain	FLU3~SANOFI PASTEUR~U1914AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249374	12/16/2005	MN	70.0	69		F	12/07/2005	Swollen upper left arm, sore, hard, reddened. (twice the size)  Had received pneumonia vaccine on 11/14/03-but did not remember it when screened on 11-14-05.									Y	11/14/2005	11/14/2005	0	NONE	PUB	PUB		NONE	NONE			1						1	Erythema; Injection site induration; Myalgia; Swelling	FLU3~SANOFI PASTEUR~U1881AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249375	12/16/2005	CT	8.0	8		F		3x3x5 cm region of induration with eczematons patch at injection site.  Mild elevation in eosinophils on CBC 10%.  WBC 9,100; Poly 32; Lymph 52; Mono 5 Eo 10 Base 1.									Y	10/28/2005	12/01/2005	34	RAST: 1.07 KU/L 173% Ret moderate response; CBC, RAST for eggs.	PVT	PVT		No acute illness	severe anoxic encephalopathy secondary to Birth Asphyxia resulting in persistent vegetative state, seizure disorder, spastic quadriplegia with dystonic posturing, gastrostomy tube feeds for nutrition, tracheostomy tube placement secondary to upper airway obstruction, aphagia with aspiration, ventilator dependency, history of ARDS 1999, constipation, eczema, MRSA colonization, question of SIADH, sensory perceptual deficit			1						1	Eosinophilia; Hypersensitivity; Injection site induration	FLU3~SANOFI PASTEUR~U1802BA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249376	12/16/2005	MI	4.0	4		F	11/29/2005	L arm swelling and fever-seen in ER on Saturday and in office on Monday.  Got shots on Friday at Health Dept..				Y					Y	11/18/2005	11/18/2005	0	CBC, Bld culture negative, chest xr normal.	PUB	PUB		NONE	Asthma			1						1	Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U1747AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0249378	12/16/2005	CT	2.0	2	.1	M	12/12/2005	Flu shot 10/18/05, 12/8/05 about 3 days with 2nd dose hives on stomach/neck.  zero trouble breathing.									Y	12/08/2005	12/11/2005	3	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1912AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249379	12/16/2005	IN	55.0	55		F	12/09/2005	12/6/05:started feeling extremely tired, headache; removed Bandaid entire area underneath was red; 12/7/05: noticed scratch marks approx 2-3 away from site; 12/8/05: stayed home from work for rest; 12/9/05: Contacted VAERS, was advised to see to see a doctor; Contacted 122 MDG, sent to Dupont ER for immediate treatment.				Y					U	12/03/2005	12/05/2005	2		MIL	MIL	Nexium 40mg	NONE	Acid Reflux			1						1	Erythema; Fatigue	FLU3~SANOFI PASTEUR~U1911AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~9020072~UNK~~~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0249381	12/16/2005	MA	74.0	73		M	12/13/2005	Experienced severe pain in chest cavity right side, headache, abdominal pain, feeling very cold. Abdominal and chest pain subsided in early morning following day. Headache subsided around noon. Does not think temp elevated. Was seen by his urologist 5 days later after Cystoscopy and PSA blood work. PSA elevated from 4.6 - 5.6. PSA to be repeated as MD thought flu shot or cystoscopy could account for PSA elevation. Was not 1st flu shot. No adverse reaction in past to flu vaccine.									Y	11/01/2005	11/01/2005	0		PUB	PUB	Proscar, Flomax, Inhalers emphysema.	NONE	Emphysema, Hypertension, Prostate enlarges.			1						1	Abdominal pain; Chest pain; Feeling cold; Headache; Prostatic specific antigen increased	FLU3~SANOFI PASTEUR~U1831AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249382	12/16/2005	CA	0.09	0	.1	M	12/12/2005	Infant less than 2 months of age received Flu Vac.									U	12/12/2005	12/12/2005	0		OTH	PUB						1						1	Medication error	FLU3~SANOFI PASTEUR~U1743LA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249407	12/16/2005	OH	52.0	51		F	12/16/2005	Cellulitis diagnosed by the ER but review of chart by me along with other reports of acute cellulitis diagnosed in ER in post vaccinees makes me think most likely scenario is vigorous local reaction.  Clindamycin prescribed.  Swelling started one day after vaccine and extended above shoulder and below arm				Y						11/10/2005	11/13/2005	3	none	UNK	UNK	unknown	none	unknown			1						1	Cellulitis	FLU3~SANOFI PASTEUR~~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1006P~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0249409	12/16/2005	ME	62.0	62		F	12/16/2005	Approximately 3-4 hours after receving vaccine developed achiness and general malaise. Woke next morning with fullness in throat, nausea, achey, chills. No respiratory difficulty nor wheezing.									Y	11/07/2005	11/07/2005	0		MIL	PVT						1						1	Chills; Malaise; Nausea; Pain; Throat tightness	FLU3~SANOFI PASTEUR~U1912AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249412	12/16/2005	CA	43.0	43		M	12/16/2005	Tues 13 DEC PM - Fatigue, muscle and headaches, late PM fever 102 deg. Wed 14 DEC AM - 102 deg. fever, nausea, sore throat, fatigue, dizzy, muscle and headaches, and PM vomiting, sweats and chills. Thu 15 DEC AM - nausea, sweats and chills, sore throat, fatigue, dizzy, muscle and headaches. Early PM temp 98.6 Fri 16 DEC - fatigue, dizzy, muscle and headaches. Treated with OTC medications 3 days of work lost.									Y	12/10/2005	12/13/2005	3	None performed	MIL	MIL	None	None	None			1						1	Chills; Dizziness; Fatigue; Headache; Hyperhidrosis; Myalgia; Nausea; Pharyngolaryngeal pain; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0249415	12/16/2005	MN	17.0	17		M	12/16/2005	Diagnosed with new onset Diabetes Mellitus, Type I (December 11, 2005).					Y	3				11/04/2005				UNK	UNK						1						1	Diabetes mellitus	FLU3~SANOFI PASTEUR~U1802BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1768AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Hospitalisation	Influenza
0249417	12/16/2005	MD	85.0	85		F	12/16/2005	Complained of vertigo. She is subject to vertigo but it was so bad she went to the Emergency room.				Y					Y	12/03/2005				UNK	UNK						1						1	Vertigo	FLU3~SANOFI PASTEUR~U1935AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249418	12/16/2005	MO	56.0	55		F	12/16/2005	12/12/05 BP today at 160/98 Pulse 98bpm.  Cient presents today with c/o adverse reaction from influenza vaccine she received on 12/5/05 at our office.  Noted area to left deltoid at ~2 x 3/4 with faint yellowish-green area appearing to be old bruise.  Client states that within 30 minutes after receiving flu shot, she became symptomatic with dizziness, heart palpitations, swollen tongue, whelps to tongue, and nausea.  States later in day developed loose stools that persisted for ~1 week.  Discussed VIS information including recommendations to follow-up with PCP for such symptoms.  Client voiced understanding.  States she feels it was a reaction to the vaccine and nothing else was different in her daily routine, intake, or encounters to cause a reaction except this vaccine.  States symptoms persist today including occasional palpitations, dizziness, occasional nausea, and sweating.  Discussed increased pulse and BP findings and encouraged follow-up with PCP immediately for evaluation.  Client voiced understanding.  Plans to seek medical care today with PCP.  Discussed need to avoid flu vaccine in future until allergic reaction ruled out by PCP.   Client states at onset of symptoms after shot received, she took P.O. Benadryl with relief of swelling.  Has not taken any other medication or done any further interventions for tx since 12/5/05.   12/16/05  T.C. to client.  States she went for appt with NP and was told that it would be greater than 1 week before appt date so she decided to go home and see if symptoms stopped.  States she is no longer experiencing problems and does not plan further follow-up.  States she will no longer take flu shot in future. Questions encouraged.				Y					Y	12/05/2005	12/05/2005	0		UNK	UNK	None listed	None noted	Allergy: PCN, Codeine, Sulfa; Hx of Bells Palsy 2002			1						1	Contusion; Diarrhoea; Dizziness; Heart rate increased; Hyperhidrosis; Nausea; Palpitations; Tongue oedema; Urticaria	FLU3~SANOFI PASTEUR~U1854AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249419	12/16/2005	IA	66.0	66		F	12/16/2005	Patient received vaccine on 11/9/05 afternoon and states on the morning of 11/10/05 she experienced severe pain in the injection site of the L deltoid, radiating upward to the L shoulder and neck area, as well as radiating downward to the wrist area with numbing and tingling of the middle finger. Patient states the injection site, beneath the skin is 'lumpy.' Note - Patient reported adverse event to Health Department on 12/16/05.				Y					N	11/09/2005	11/10/2005	1	Patient reports an x-ray of L arm was completed with no abnormalities reported.	UNK	UNK	Patient report taking Effexor XR; Lantus 15U qd; Avandia qd;	None; routine screening for allergies, past allergic rx, Guillain-Barre and fever completed prior to vaccination.	NKA; Diabetes, Depression			1						1	Hypoaesthesia; Injection site mass; Injection site pain; Paraesthesia; Hypoaesthesia; Hypokinesia; Injection site mass; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U1849AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0249421	12/16/2005	UT	20.0	20		M	12/16/2005	Patient states he noticed faded red spots around the Smallpox vaccination site which were hot to the touch when he changed his bandaid at 0700 hours on Wednesday, 14 Dec 2005.  Patient states spots were more solid and zit-like, dark red, and hot to his touch when he checked the same site on Thursday, 15 Dec 2005, at 0700 hours.  Patient presented to this Immunization Clinic at 0940 hours on Friday, 16 Dec 2005 requesting to have his Smallpox sited checked.  After viewing the site we asked the PAC to also view the site.  The PAC viewed the site and had the patient return with her to the clinic where the patient underwent an office visit with the PAC.  See diagnosis and prescription information in box 12.				Y					U	12/06/2005	12/14/2005	8	PAC diagnosed the patient with - vaccinia and cellulitis of the vaccine site. PAC prescribed the following medications: Zyrtec 10 mg Sig: take 1 tablet by mouth daily as needed for allgery; Keflex 500 mg  Sig: take 1 capsule by mouth four times daily until gone for infection; Zantac 150 mg Sig: take 1 tablet by mouth twice daily.	MIL	MIL	Smallpox given per Milvax site instruction (scar).  No other vaccinations received by patient between 15 January 2005 and 6 December 2005.	None	No known allergies to medications. No known allergies to foods. No know allergies to vaccines received prior to 6 December 2005.			1						1	Cellulitis; Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U1916AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020072~1~ID~RA~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~Z0042~1~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0249422	12/16/2005	CA	7.0	7		F	12/16/2005	Syncope x 2, pallor, and lethargy 16 hours post administration of influenza vaccine.  CBC and comprehensive metabolic panel obtained, results normal, treated with IV hydration x 2 hours and monitored closely in clinic, condition stable, discharged home.				Y					Y	12/15/2005	12/16/2005	1		UNK	UNK	Tylenol	None	Acute lymphoblastic leukemia	Fever, severe leg pain~Influenza (Seasonal) (no brand name)~1~4.30~In Patient		1						1	Lethargy; Pallor; Syncope	FLU3~SANOFI PASTEUR~U1802AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249427	12/16/2005	PA	39.0	38		M	12/16/2005	Started around 2:00 am severe chills, sweats, fever, nausea, body aches continues with symptoms at time of documenting this.									N	12/15/2005	12/16/2005	1		PVT	PVT		NONE	Allergies - PCN			1						1	Chills; Hyperhidrosis; Nausea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1827AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249428	12/16/2005	MN	12.0	11		F	12/16/2005	Child was vaccinated within 1-2 minutes collapsed was lowered to ground by mom and nurse, had stiffening of right arm, clenching teeth, held breath, unresponsive lasted about 20-30 seconds, recover completely within 90 minutes.				Y					U	12/05/2005	12/15/2005	10	MRI;EEG	PVT	PVT	NONE	NONE	NONE			1						1	Breath holding; Bruxism; Coma; Loss of consciousness; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~1913AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249436	12/16/2005	NJ	56.0	55		F	12/06/2005	Received pneumovax right arm on Fri. By saturday am arm was sore. By Sunday am, could not raise arm. Had burning, sharp pain radiating from jaw down neck, to injection site, to elbow, thumb and 1st 2 fingers of right hand. Is wearing sling on advice of physical therapy friend; taking ibuprofen and icing arm.				Y					U	12/02/2005	12/04/2005	2		PUB	PVT			Lyme disease		NJ200515	1						1	Joint range of motion decreased; Neck pain; Pain; Pain in jaw	FLU3~SANOFI PASTEUR~U1936AA~1~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1048P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0249423	12/18/2005	TN	43.0	42		F	12/18/2005	Vaccine taken at 10:40 AM.  Fatigue within 30 minutes.  Fever, muscle aches, headache, cough, chest congestion, and sore throat began at approximately 3:30 PM.  Left eye became very red, itchy, and swollen at about 8 PM.  None of these symptoms were present before the vaccination.  Treated fever with Tylenol.  Treated eye symptoms with Elestat.									Y	12/13/2005	12/13/2005	0	N/A	UNK	UNK		Slight cold with sniffles.				1						1	Cough; Eye irritation; Eye swelling; Headache; Myalgia; Nasal congestion; Ocular hyperaemia; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~49281037615~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249426	12/19/2005	CA	44.0	44		F	12/17/2005	Cellulitis versus vaccine drug. Pt seen 12/15/05 after receiving inj. 12/12/05 right deltoid.				Y						12/12/2005				PVT	UNK		NONE	Allergy: Codeine;Morphine;ASA;PCN			1						1	Cellulitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62445~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0748P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0249444	12/19/2005	IN	54.0	54		F	12/14/2005	Admitted to hospital with Guillain Barre syndrome. Onset of symptoms 11/29/2005 tingling extremities. 12/01 difficulty walking, 12/03 admitted to hospital due to low back pain and difficulty walking. 12/05 numbness in lower extremities, limited range of motion, weakness in all extremities. Transferred to different hospital on 12/05/2005. Discharge summary states pain of skin, atelecticsis, respiratiory insufficency. msv Per 60 day follow up report- Continues to receive IVIG every other week. Condition gradually improving. Still has impaired mobility. Foley cath remains anchored PEG tube removed 2-28-06. Was a swing bed patient at out facility 1/10/06 to 2/7/06. Currently continuing recovery at home. 02/08/2007 per patient repat- states has rediual effects including diminished sensation in feet from the ankles down.  Still has some balance problems.  One numb finger.  He has returned to work.			Y	Y	Y		Y		N	10/31/2005	11/29/2005	29	Discharge summary states hyponatremia, abnormal CSF, hypothyroid, abnormal lab test. msv	PVT	PVT	UNK		Discharge summary states hypertension, hypothyroid. msv			1						1	Asthenia; Atelectasis; Back pain; Balance disorder; CSF test abnormal; Gait disturbance; Guillain-Barre syndrome; Hypoaesthesia; Joint range of motion decreased; Laboratory test abnormal; Paraesthesia; Respiratory failure	FLU3~SANOFI PASTEUR~U1849AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0249447	12/19/2005	CA	11.0	11		F		2.5 macular rash with tenderness at upper arm. Flu shot administered 23 hours earlier at another facility.									U	11/29/2005	11/30/2005	1	NONE	OTH	OTH	NONE	UNK	UNK			1						1	Rash macular; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0249448	12/19/2005	PA	53.0	52		F		High fever, all body aches, pain, severe congestion, coughing, fatigue. Received Advil 200mg IT PO Q 4-6 hours. Ocean Spray, increased fluid intake.				Y						11/21/2005	11/21/2005	0	Most like flu/viral. Not ordered.	PUB	UNK			NONE			1						1	Cough; Fatigue; Nasal congestion; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62018~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0249449	12/19/2005	OH	31.0	30		F	12/12/2005	Patient complained that injection hurt more than usual when received it on 11/18/05. Stated when woke up next morning, 11/19/05, arm hurt to move it certain way or to lift anything. Stated continues to have this same sore muscle ache now when moves deltoid muscle or lifts anything. Has been taking Advil for pain. Stated no fever nor other symptoms noted; just the pain at injection site for 3.5 weeks. States area does not hurt when pushed on. Plans to follow up with physician for evaluation.									U	11/18/2005	11/19/2005	1		PUB	PUB	Folic acid; Centrum; Calcium; BC pill	NONE	History of asthma.			1						1	Hypokinesia; Injection site pain; Myalgia; Pain	FLU3~SANOFI PASTEUR~U1838AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249450	12/19/2005	NY	61.0	61		F	12/08/2005	Client came into our office; left upper arm swollen, redden and warm to touch. No harden area. Instructed client to call her MD to be seen and to apply cool compress to area for relief. 12/9 Client saw MD; he prescribed antihistamine, prednisone and Keflex 500mg BID for 10 days. Spoke to client 12/13. She is doing well; no redness or swelling noted.									Y	12/07/2005	12/07/2005	0		PUB	PUB		NONE	Environmental allergies			1						1	Erythema; Injection site warmth; Swelling	FLU3~SANOFI PASTEUR~U1916AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0486P~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249451	12/19/2005	PA	67.0	67		M	11/07/2005	2 hours past receiving vaccine, started with chills, fever 99-100, edema from armpit to lower lateral arm, redness and pain. Symptoms subsided 3 days later.									Y	11/03/2005	11/03/2005	0		PUB	PUB	Hydrodiural 25mg	NONE	NONE; History of Prostate cancer			1						1	Chills; Erythema; Oedema peripheral; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1804AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249452	12/19/2005	PA	66.0	65		F	11/07/2005	Vaccine given at approximately 10 AM 11/3/05. BY evening, client reports fever 102, edema from armpit to elbow, diaphoresis, pain and redness at left injection site. Next day, client extremely lethargic and tired - slept all day. Continued with intermittent fever for 4 days. 11/7/05 Symptoms subsiding.									Y	11/03/2005	11/03/2005	0		PUB	PUB	Hydrodiuril; Evista; Ca Nasal Spray; Miralax; Lactulose	NONE	Allergy ASA; Amoxillin; IBS			1						1	Fatigue; Hyperhidrosis; Injection site erythema; Injection site pain; Lethargy; Oedema peripheral; Pyrexia	FLU3~SANOFI PASTEUR~U1804AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249453	12/19/2005	CT	44.0	44		F	12/19/2005	Vaccine administered 10:00 AM. Became itchy around 3:00 PM and developed welt on abdomen. Around 5:00 PM, she went to ER when she developed tongue swelling. Has history of 5 throat closures due to bee stings and other allergies. Received Albuterol, Prednisone and Benadryl from ER visit. Discharged without further complications 12/14/05.				Y					Y	12/14/2005	12/14/2005	0	Allergic reaction	OTH	OTH	Yes (did not want to disclose meds).	NONE	Asthma; Hearing impairment; Foot neuropathy			1						1	Hypersensitivity; Pruritus; Tongue oedema; Urticaria; Hypersensitivity; Pruritus; Tongue oedema; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62754~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~6275U~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0249453	12/19/2005	CT	44.0	44		F	12/19/2005	Vaccine administered 10:00 am. Became itchy around 3:00 pm and developed welt on abdomen. Rounded 5 am she went to ER when she developed tongue swelling. Has history of 5 throat closure due to bee stings and other allergies. Received albuterol , prednisone, epinephrine and Benadryl from  ER Visit. Discharged without further complications.H/O 12/19/05				Y						12/14/2005	12/14/2005	0	Allergic RXN	OTH	OTH	Yes (Patient did not want to disclose meds)	NONE	Asthma, Hearing impairment;Right foot neuropathy			1						2	Hypersensitivity; Pruritus; Tongue oedema; Urticaria; Hypersensitivity; Pruritus; Tongue oedema; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62754~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~6275U~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0249454	12/19/2005	CA	4.0	4		F	11/17/2005	10cmx7cm area of erythema, swelling and warmth of injection site. Resolved with Benadryl.				Y					Y	11/07/2005	11/09/2005	2	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1864AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249455	12/19/2005	CA	3.0	3		M	11/18/2005	Large, purplish area of swelling (16cm x 8cm) at injection site.				Y					Y	10/27/2005	11/02/2005	6	NONE	PVT	UNK	Albuterol after onset of reaction		Prematurity			1						1	Injection site swelling; Skin discolouration	FLU3~SANOFI PASTEUR~U1864AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249456	12/19/2005	CA	5.0	5		F	11/17/2005	11/9/05 Flu vaccine administered. 11/11/05 Half of thigh swollen, red, warm to touch. Resolved with Benadryl.									Y	11/09/2005	11/11/2005	2	NONE	PVT	PVT	NONE	NONE	Milk intolerance in infancy (resolved). History of urticaria 6/05.			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1864AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249457	12/19/2005	NC	73.0	72		M	12/14/2005	Mouth with numbness inside and left arm had strange feeling also two fingers on left arm that lasted for 2 hours.									Y	10/26/2005	10/26/2005	0		PUB	PUB			artery disease		NC05119	1						1	Flat affect; Hypoaesthesia	FLU3~SANOFI PASTEUR~U1846AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249458	12/19/2005	NC	76.0	75		F	12/14/2005	Lips became numb and right eyelid for short time. Lips stayed numb. C/O starting to have chills. Lasted x 3 hrs. Also numbness left arm and little two fingers. C/O on 10/29/2005 level numbness of lips.									Y	10/26/2005	10/26/2005	0	NONE	PUB	PUB	BP Med	NONE	On BP Med.		NC05118	1						1	Chills; Hypoaesthesia	FLU3~SANOFI PASTEUR~U1846AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249459	12/19/2005	CA	50.0	50		F	12/14/2005	Mild muscular pain (at rest) with moderate pain on movement days 2-4 following flu shot. Resolved on day 4. One week post flu shot, following light workout, left arm with moderate to severe pain radiating to socket and occasionally down left arm. Left arm pain subsided over next 4 days. Pain somewhat relieved by 400 mg ibuprofen. Resolved 12/11/05									Y	11/30/2005	12/07/2005	7		PVT	PVT						1						1	Arthralgia; Myalgia; Pain	FLU3~SANOFI PASTEUR~U1865AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249460	12/19/2005	NE	49.0	49		F	12/11/2005	Patient has been experiencing pain in the right arm where her flu shot has been given since of vaccine. It sometimes goes down her arm and neck. She has been using a warm compress and Aleve without any relief.				Y					N	11/19/2005	11/19/2005	0	NON	OTH	OTH	NONE	NONE	Allergies to sulfonamides, Macrodantin.			1						1	Injection site pain; Neck pain	FLU3~SANOFI PASTEUR~U1866AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249461	12/19/2005	IL	1.51	1	.5	F	12/08/2005	Right arm upper swollen and extended to shoulder neck, and right cheek. reaction occurred first 24-48 hours. Patient went to ER, Benadryl given. No shortness of breath. F/U at PMD, with decreased swelling localized right deltoid and clavicular area. Continued Benadryl and cool compressed.				Y					Y	11/29/2005	11/30/2005	1		PVT	PVT	Benadryl		GERD, Atopic dermatitis, Bronchiolitis			1						1	Oedema	DTAP~SANOFI PASTEUR~U1369CA~4~~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1867DA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE533AA~2~~RA~HIB (ACTHIB)~1	USA	Emergency room visit	Influenza
0249462	12/19/2005	DE	31.0	30		F	12/08/2005	On 11/16/2005 Starting with pruritus on back. On 11/17/2005 developed a patchy area on back, pruritic it raised with blisters forming. Saw MD on 11/25/05 due to additional raised patches on mid back and right ribs and pain. Placed on RX acyclovir 5 QD for 7 days. Out of work 11/28/08 to 12/02/05. Saw MD again 11/29/05 for increased pain, placed on Gabapentin. As of 12/08/2005 done with acyclovir and off Gabapentin and returned to work 12/05/05. Has pain on and off now. Continues with pruritus and rash resolving, blisters are resolved.				Y					Y	11/14/2005	11/16/2005	2		PVT	OTH	Augmentin	Eye infection	NONE			1						1	Blister; Pain; Pruritus; Rash; Rash maculo-papular	FLU3~SANOFI PASTEUR~U1881AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249463	12/19/2005	IL	45.0	44		F	12/08/2005	Reported 6 hours after received flu shot had pretty intense myalgia. This was relieved: motrin and a night's rest. On 11/21/05 Patient wondered if it was possible to develop herpes zoster without blisters. She was diagnosed with this after seeing her MD for right hip pain. I called CDC NIP hotline and informed no known correlation between flu shot and development og herpes zosters. I left a message on the CDC hotline and never got a call back. I called VAERS and only got a recording. I would have like to have beneficial to speak to someone from VAERS to see if completion of this form was necessary.				Y					Y	11/11/2005	11/11/2005	0		PVT	OTH			allergy to PCN, sulfa			1						1	Arthralgia; Herpes zoster; Myalgia	FLU3~SANOFI PASTEUR~U1881AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249464	12/19/2005	MA	87.0	86		F		11/02/2005 pain at injection site all night. Unable to sleep went to ER 11/03/2005am. Redness around site 3-4 swollen. Given IV antibiotics in ER, home with Keflex prescription and Percocet. 11/04/05 appt with own MD ? allergic reaction. Became sick on Keflex and was discontinued.				Y					Y	10/31/2005	11/12/2005	12	NONE	PUB	PUB	Norvasc, ASA		Ocean fish, Hypertension, arthritis.			1						1	Hypersensitivity; Injection site hypersensitivity; Injection site oedema; Injection site pain; Insomnia; Malaise	FLU3~SANOFI PASTEUR~U1854AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249465	12/19/2005	CA	0.7			F	12/16/2005	Parent reported seeing child have rhythmic 20 sec right arm/leg twitching for 4 days (intermittent) This reminded mom of aunt who had a stroke. Mom reported this on a routine follow up today.									Y				NONE	PVT	PVT	NONE	NONE	Prematurity 34 4/7 gestation at birth			1						1	Muscle twitching	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B028AA~3~~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1743LA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE762AA~3~~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A56077R~3~~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0249466	12/19/2005					U	12/15/2005	Egg size lump on arm where flu shot was given.										10/21/2005				UNK	UNK						1						1	Injection site mass	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249467	12/19/2005					F	12/15/2005	Day #1 Left upper arm, Flu shot. Day #2 Site extremely swollen, red, hot to touch, itchy deep under site. Approx 7x7 cm site lymph node swollen under left arm lasted thru the weekend.														UNK	UNK						1						1	Hypersensitivity; Injection site erythema; Injection site reaction; Injection site swelling; Injection site warmth; Lymphadenopathy; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA129AB~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249468	12/19/2005					F	12/15/2005	Redness and itchy										10/20/2005				UNK	UNK						1						1	Erythema; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA129AB~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249471	12/19/2005	OH	64.0	64		F	10/14/2005	Got pneumonia shot 10/12/05. On 10/13/05, got swelling in upper arm and fever of 101.3. Able to control with ice and Ibuprofen.									Y	10/12/2005	10/13/2005	1		PUB	PVT			NONE			1						1	Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U1839AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0607R~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249472	12/19/2005	OH	53.0	52		F		Arm was swollen, red and warm to the touch. After a couple of days swelling and redness started to go away.									Y	11/15/2005	11/15/2005	0		UNK	PVT		NONE	NONE			1						1	Erythema; Feeling hot; Oedema	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0914P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249473	12/19/2005	OH	64.0	64		F	10/08/2005	Diarrhea, vomiting, fever, extreme thirst.									Y	10/05/2005	10/05/2005	0		OTH	PUB		NONE	UNK			1						1	Diarrhoea; Pyrexia; Thirst; Vomiting	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249474	12/19/2005	OH	67.0	67		F	10/10/2005	Lethargy, nausea,lightheaded.									Y	10/05/2005	10/05/2005	0		UNK	UNK						1						1	Dizziness; Lethargy; Nausea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~U17472AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0249475	12/19/2005	OH	53.0			F	10/02/2005	Redness around injection site approx 4 diam, warm area and painful. Reaction began approx 6:00 pm after I had just returned from store. Area has steadily increased with approx size.														UNK	UNK		NONE	NONE	Redness and swelling~Influenza (Seasonal) (no brand name)~1~51.00~In Patient		1						1	Feeling hot; Injection site erythema; Pain	FLU3~SANOFI PASTEUR~U1839AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749P~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249476	12/19/2005	OH	51.0	50		F	10/31/2005	Edema and redness the morning after vaccination, lasting 3 days.									Y	10/28/2005	10/29/2005	1	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Erythema; Oedema	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0815P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249477	12/19/2005	OH	46.0	46		F	10/17/2005	Reported rash on face and upper body this past weekend. She called her doctor and he referred her to us. Not having trouble breathing. I recommended Benadryl to help rash.									U	10/14/2005	10/15/2005	1		OTH	OTH	Potassium;Duragesic;Lidoderm;Paxil;Topamax;Fluoroplex;Trazodone		Multiple Sclerosis			1						1	Rash	FLU3~SANOFI PASTEUR~U1839AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249478	12/19/2005	MI	50.0	50		F	10/27/2005	Left arm swollen, red down to elbow. Tender at injection site. Used Ibuprofen and cold compresses the first 24 hrs but didn't go away. Pharmacist called her MD and advised pt to got to urgent care.				Y					U	10/25/2005	10/26/2005	1		OTH	OTH		NONE	Recovering from Breast Cancer			1						1	Erythema; Injection site reaction; Oedema; Tenderness	FLU3~SANOFI PASTEUR~U1746AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0249480	12/19/2005	MI	62.0	62		F	10/21/2005	10/21/05 Husband took patient to therapy in morning where she felt dizzy and nausea occurred. Patient experienced vomiting episode.									Y	10/20/2005	10/21/2005	1		OTH	OTH	Fentanyl 100mcg;Lymca 75mg					1						1	Dizziness; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249481	12/19/2005	OH	69.0	68		M	12/01/2005	Area of arm where vaccine was administered is red, painful, swollen and feels hot. Pt is using ice, but refuses ibuprofen. Pt called back on 12-2-05 did take ibuprofen on 12/1/05.									U	11/30/2005	11/30/2005	0	NONE	OTH	PVT	Levaquin;Prevacid	Diverticulitis- recovering vaccine	Allergies- PCN;Ceclor;Iodine			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1869AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1046P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249482	12/19/2005	OH	69.0	69		F	10/15/2005	Pt phoned Saturday afternoon said they had received a pneumonia vaccine on 10/14/05. Area where vaccine was given red and sore mildly inflamed. Told pt to use ice and either Tylenol or Ibuprofen. If inflammation becomes worse or developed other symptoms contact doctor.									Y	10/14/2005	10/15/2005	1		OTH	OTH		NONE	UKN			1						1	Injection site erythema; Injection site inflammation; Myalgia	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0799P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249483	12/19/2005	OH	73.0	73		M	10/16/2005	(Describe by daughter) Morning the day after vaccination (10/15) unable to move right arm. (one that had pneumonia shot) and feel sick and weak. Symptoms got worst the next day (10/16) vomit several times, too weak that barely able to get up out of bed. (No redness or swollen around the site of injections) Advise daughter to call 911.				Y					U	10/14/2005	10/15/2005	1		OTH	UNK		Recovering from a cold				1						1	Asthenia; Hypokinesia; Malaise; Vomiting	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0249484	12/19/2005	OH	81.0	80		F	10/16/2005	Diarrhea and vomiting (dry heaves) during night 10/13. 10/14 Called nurse line who told her to drink tea and take Imodium  did not feel it was related to flu shot.									Y	10/13/2005	10/13/2005	0		OTH	PUB		NONE	NONE			1						1	Diarrhoea; Retching	FLU3~SANOFI PASTEUR~U1833DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249485	12/19/2005	MI	81.0	81		F	10/29/2005	Patient called pharmacy on 10/28/05 around 11 am, said that her right arm hurts a lot and its very difficult to move above head (right arm being site of injection on 10/21/05). She stated that the pain started 10/22/05 but its worse now.										10/21/2005	10/22/2005	1		OTH	UNK		NONE	Pt said she had cortisone shot in same arm about 2 months ago			1						1	Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U1747AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249491	12/19/2005	GA	37.0	37		F		Injection given 12/12/05 and noticed swelling 9cm below site (left deltoid) given in deltoid area. Swollen, tender, and slight numbness and progressively got more numb no sign of infection. Area of swelling 5 cm x 5 cm. Seen 12/18/05 swelling gone away, no numbness.									Y	12/12/2005	12/13/2005	1		OTH	PVT						1						1	Hypoaesthesia; Injection site oedema; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~63194~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0249492	12/19/2005	MN	9.0	9		M	12/16/2005	Hives on his elbows, ankle, leg, groin, buttocks, foot.									Y	12/15/2005	12/15/2005	0		PVT	PVT		Sore throat, cough, runny nose, mattery eyes, no fever.				1						1	Urticaria	FLU3~SANOFI PASTEUR~U1913AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249493	12/19/2005	VA	32.0	32		F	12/19/2005	Dizziness, x20secs  several episodes and shoulder muscle aches within 72hrs of vaccine repeat of Sx three days later  Dizziness worse with lying down bending over and changing positions from lying to standing  no sycope									Y	11/15/2005	11/18/2005	3		UNK	UNK	Oral contraceptive	none	none			1						1	Dizziness; Myalgia	FLU3~SANOFI PASTEUR~U1826AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249494	12/19/2005	ID	69.0	69		F	12/19/2005	SWELLING, REDNESS, WARMTH AT INJECTION SITE AND A HEADACHE LASTING FOR 4 DAYS.  NO LONG TERM PROBLEM. Reaction occured on left arm, site of Flu and Pneumonia.									Y	10/27/2005	10/28/2005	1		UNK	UNK	PREMARIN, MOVIC, AVAPRO, PRILOSEC, LIPITOR, METOCLOPRAMID	N/A	HTN, ARTHRITIS			1						1	Headache; Injection site hypersensitivity; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U1903AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1039P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U1586CA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0249495	12/19/2005	FL	1.0	0	1	M	12/19/2005	Approx. one minute after administering vaccines, pt developed erythema accompanied by hives. Pt scratched some areas. Pt was without s/s of respiratory distress. Pt given Benadryl 12/5 5ml po and Prelone 5ml po. Pt monitored for over a hour. Pt given referral to allergist, rx for benadryl and return appointment for tomorrow.									Y	12/19/2005	12/19/2005	0		UNK	UNK		NA	NA			1						1	Erythema; Urticaria	FLU3~SANOFI PASTEUR~pmcu1765ga~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~MSD0482R~4~IM~RA~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~MSD0236R~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~WYB08634C~5~IM~RA~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~MSD0418R~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0249496	12/19/2005	OK	57.0	57		F	12/19/2005	At 1800 jaw pain started, felt tight and burning, face,lips and eyes swollen within 30 minutes, progressed to headache and swollen neck.  Took Ibuprofen and went to sleep at 2100.  By 2300 burning was resolved but swelling continued until noon the next day.  No coughing, hives or wheezing reported.									Y	11/18/2005	11/18/2005	0	None, did not seek medical care.	UNK	UNK		None				1						1	Face oedema; Headache; Oedema; Pain in jaw; Periorbital oedema	FLU3~SANOFI PASTEUR~U1881AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249497	12/19/2005	AL	43.0	43		F	12/19/2005	Lost hearing in her right ear due to neuronitis possibly from live virus administration to nasal mucosa. 2/23/06 - medical record reviewed. Pt c/o R ear pain on 2/14/05 followed by dizziness and recurrent pain after treatment. On 3/4/05 pt was diagnosed with OM chronic mucosanguineous R ear and restarted on Biaxin and Duratuss. On 3/15/05, the patient was diagnosed with otitis media nonsuppurative serous after fluid was shown behind TM on audiogram. It was recommended that patient not receive further FluMist vaccines. An aeromedical summary dated 11/4/05 stated diagnosis as sensorineural hearing loss caused from FluMist vaccination. 03/31/2010 Follow-up: Permanent sensorinerial hearing loss most likely secondary to viral neuronitis (moderate to severe hearing loss).								Y	N	01/07/2004	01/10/2004	3	Audiograms repeated	MIL	MIL		viral neuronitis 2/23/06 - review of medical records indicates there was no pre-existing illness at time of vaccination.	cleft lip repair, bifid uvula			1						1	Audiogram abnormal; Deafness neurosensory; Deafness unilateral; Dizziness; Ear pain; Neuritis; Otitis media chronic	FLUN3~MEDIMMUNE VACCINES, INC.~500357P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Disabling	Influenza
0249498	12/19/2005	IL	11.0	11		M	12/19/2005	Pt recieved Flu vaccine and Td vaccine per doctor's orders.  Pt turned red on arms, face and torso within 10 seconds of vaccine.  MD was notified immediately.  Child received one tsp antihistamine immediately.  Remained in clinic for 30 minutes.  No signs of resp distress, no complaints of difficulty breathing.  Pt did stated that he did feel a little itchy and mouth felt itchy.  MD escorted pt to ER.  Pt was released from ER, no epi given, but was given steroids.  MOP stopped back in Peds after ER visit to verify meds with MD.  MOP given home instruction, child was in NAD.									Y	12/15/2005	12/15/2005	0	observation in Peds clinic and ER	MIL	MIL	unsure	Was seen in clinic that day for sinus drainage and headache.	No allergies per MOP			1						1	Erythema; Pruritus	FLU3~SANOFI PASTEUR~U1858CA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U1636BA~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0249500	12/19/2005	WA	48.0	48		M	12/19/2005	24 hours after shot-12/10, approximately 2 pm,started feeling sick to my stomach, body aches, went to bed.  The next day, 12/11, had diarrhea, body aches, chills, headaches, felt nauseated, felt like vomiting, but couldn't. These symptoms continued until 12/18 at which time I started feeling better.  On Thrusday, 12/15/, went to the employee health center to see if they could give me anything for the nausea, they could not, they told me I should go home if I had diarrhea.  This was around 10:30 am, I finished out my shift, around 2 pm.  The next day, 12/16, went again to employee health, again the same, could not give me anything, told me to go home or see my doctor. This was around 8:15 am, went and made an appointment with my doctor for 10:00am.  Went to my doctor at that time, was told there wasn't much to do, just rest and take tylenol, which I did.				Y					Y	12/09/2005	12/10/2005	1		UNK	UNK	none	none	none	same as described above~Influenza (Seasonal) (no brand name)~1~0.00~In Patient		1						1	Chills; Diarrhoea; Headache; Nausea; Pain; Stomach discomfort; Vomiting	FLUX~UNKNOWN MANUFACTURER~41864AA~1~ID~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0249501	12/19/2005	WI	0.5	0	.5	F	12/19/2005	Received vaccine on afternon of Nov. 2. On Nov. 4 woke up in a.m. short of breath. As day went on, I became lightheaded and weak. During the afternoon, I developed a sharp pain in my left side that became worse every time I took in a breath.My whole back, esp. left side, hurt by late afternoon and I had continous spasms over my entire upper and lower back. I was in extreme pain and could not stand up straight to walk and had my daughter drive me to Urgent Care late in the afternoon.  Pain lasted several days altho lessened in intensity by 11/10/05. Urgent Care MD could find no cause for pain, gave me RX for pain med and sent me home.Extreme pain at home through the night.         ( I called my MD's office earlier in the day to report that I wasn't feeling well, asked if this was normal and was told that some discomfort was normal after flu shot but to call again if I continued to feel ill.)Went to Urgent Care after clinic closed for the day.				Y					U	11/02/2005	11/04/2005	2	Urgent Care MD ordered chest x-ray, EKG, both were normal.  Blood pressure, temperature, heart rate were normal.	UNK	UNK	Clonazepam .5 mg Zyrtec 10 mg	None	Have had dystonia in neck muscles for 30+ years. Some mild arthritis in fingers.			1						1	Asthenia; Dizziness; Dyspnoea; Muscle spasms; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0249502	12/19/2005	GA	70.0	70		M	12/16/2005	Pt received Td, pneumonia and flu on 11/16/05. On 11/18/05 arms sore, shoulders upper body. Appt to doctor due to knee 11/17/05. Next week could not use upper body. 11/29/05 DR cortisone inj- anti inflammatory seldane. MRI performed 12/9/05 recommend WNL - head and neck U/S to R/O stroke. Back to MD 12-12-05 stated had to be Tetanus and Diphtheria. Dx inflammatory myopathy. Had a fever 12/9/05 has been running a low grade fever. Start prednisone today - 12/16/2005. Flu vaccine adm by Medical Center on same day 11-16-05 as pneumonia and Td. Flu adm in right deltoid. Phone CMC 12-19-05 spoke to  person to report reaction at 2:06 pm. Instructed HD completed a varies report form.				Y					Y	11/16/2005	11/18/2005	2		PUB	PVT	Seldane;Steroid pack;Cortisone shot					1						1	Hypokinesia; Myalgia; Myopathy; Pyrexia; Asthenia; Pain	PPV~MERCK & CO. INC.~0456P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~UNKNOWN MANUFACTURER~~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1823AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|TD~MASS. PUB HLTH BIOL LAB~144~UNK~~~TD ADSORBED (TDVAX)~2	USA	Emergency room visit	Influenza
0249508	12/19/2005	MI	67.0	66		M	11/03/2005	Pt reports severe discomfort right shoulder beginning with in 24 hours and continuing for 2 weeks. Unable to lift arm. Receives 6 doses Ibuprofen per day to move arm and to sleep.									U	10/21/2005				OTH	PUB		NONE				1						1	Discomfort; Hypokinesia; Insomnia	FLU3~SANOFI PASTEUR~U1839AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0579P~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249510	12/19/2005	OH	80.0	79		F	10/27/2005	Redness, swelling and pain at injection site and down arm. Patient treated with ice and ibuprofen.									U	10/25/2005	10/26/2005	1		OTH	PUB						1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U1833BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1038P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247615	12/20/2005	IL	8.0	7		F	11/15/2005	This is a serious case from a nurse in the USA of involving THROAT FELT CLOGGED. The reporter causality is possible to FluMist. This case is submitted according to the VAERS Safety Surveillance accelerated reporting agreement for FluMist. The reporter stated that a 7 year old female child with a history of mitral valve prolapse received FluMist vaccination, nasally on 11/15/05. No concomitant medications or vaccines were reported. Approximately 15 minutes after receiving FluMist the patient called from the car and reported that her throat felt clogged. There was no drooling and her breathing was normal. The physician recommended that the patient go to the emergency room for evaluation. There was no additional information at the time of this report. (OMIC)									U	11/15/2005	11/15/2005	0		PVT	PVT	NONE	Mitral valve prolapse			MEDI0003907	1						2	Throat tightness; Throat tightness	FLUN3~MEDIMMUNE VACCINES, INC.~500393P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500393P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0248120	12/20/2005	GA	5.0	5		M	12/20/2005	Patient received MMR, dTaP, Polio, and the flu vaccine at the health department.  10 minutes after, while getting into the car, the patient started experiencing a cough, rash and hives on face, body, back, and extremities, a hoarse voice, difficulty breathing, and perioral cyanosis.  Paramedics were called.  He was brought to hospital.  In the ER, he received 80 mls of NS bolus, Epinephrine IV, Ranitidine and Benadryl.  He was admitted to the PICU for overnight observation.				Y	Y	1			Y	11/16/2005	11/16/2005	0	unknown	UNK	UNK	Digoxin 90 mcg PO BID Enalapril 2.5 mg PO BID Furosemide 15 mg PO BID	unknown	double outlet right ventricle ASD/VSD and tricuspid insufficiency 1st degree AV block			1						2	Rhinitis; Urticaria; Cough; Cyanosis; Dysphonia; Dyspnoea; Rash; Urticaria	DTAP~SMITHKLINE BEECHAM~DTPa633A2~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U0846AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0324~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~00312~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|DTAP~UNKNOWN MANUFACTURER~~UNK~~~DTAP (NO BRAND NAME)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~2|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~2	USA	Hospitalisation	Influenza
0249502	12/20/2005	GA	70.0	70		M	12/20/2005	Flu vaccine was administered by our office on 11/16/05. We were contacted on 12/19/05 that this pt. had reported upper body weakness and pain; treated by his PMD. The Health Dept. had also administered a pneumonia and tetanus vaccine on the same day. Pt. was vaccinated by RN. Any added information collected on this incident will be added to this report.				Y					U	11/16/2005	11/18/2005	2	Unknown	UNK	UNK	unknown	None	unknown			1						2	Hypokinesia; Myalgia; Myopathy; Pyrexia; Asthenia; Pain	PPV~MERCK & CO. INC.~0456P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~UNKNOWN MANUFACTURER~~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1823AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|TD~MASS. PUB HLTH BIOL LAB~144~UNK~~~TD ADSORBED (TDVAX)~2	USA	Emergency room visit	Influenza
0249532	12/20/2005	MA	33.0	33		F	11/30/2005	Within 2 hours after receiving flu shot, patient felt red bumps that were abrasive to touch on her skin. She is not allergic to eggs. Last flu shot 10 yrs ago. Next day she had red spots all over her body that itched. She was taking Benadryl. No respiratory problems.									Y	11/10/2005	11/10/2005	0	Received steroids times 1 wk	OTH	PVT	Zoloft;Multivitamins	NONE	NONE			1						1	Erythema; Pruritus	FLU3~SANOFI PASTEUR~U1846AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249533	12/20/2005	MA	45.0	44		F	12/09/2005	Acute onset of coughing, hard time breathing, called PCP, went to hospital EW nebulizer 4 times felt better right away.									Y	12/05/2005	12/05/2005	0		OTH	PVT			Asthma;Cats;Feathers			1						1	Cough; Dyspnoea	FLU3~SANOFI PASTEUR~U1762AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249534	12/20/2005	OH	56.0	55		M	12/15/2005	11 am first time receiving flu shot. After 10 minutes, became diaphoretic. C/O of slight dizzy. BP 100/60, P80, R160 received epinephrine, declined to call 911, declined to call physician. Symptoms subside BP 120/184, P80,R16 after 25 minutes 11:25 am. Advised to contact physician if symptoms returned.									Y	12/15/2005	12/15/2005	0		OTH	UNK	UNK	NONE	Hypertension			1						1	Blood pressure decreased; Dizziness; Heart rate decreased; Hyperhidrosis	FLU3~SANOFI PASTEUR~U1846AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249535	12/20/2005	NY				M		Hives at site of immunization lasting 1 month									U	11/10/2005	11/25/2005	15		PVT	PVT		NONE	NONE			1						1	Injection site reaction; Urticaria	FLU3~SANOFI PASTEUR~U1733AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1822AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0249536	12/20/2005	NY	14.0	13		F	12/15/2005	Within few minutes of vaccine, patient c/o itching on her back fine flat red rash was noted covering trunk. Benadryl 25mg po given. Patient recovered without further incident.									Y	12/12/2005	12/12/2005	0	NONE	OTH	PVT	Allergy shots every 6 wks for venom allergies	NONE	Allergic to white faced wasps and hornets;Amoxicillin			1						1	Erythema; Pruritus	FLU3~SANOFI PASTEUR~U1916AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249537	12/20/2005	NJ	52.0	52		F	12/15/2005	45 min after influenza vaccination client returned to clinic stating she felt nauseated and hot. Pale, moist skin warm to touch, Client weak. B/P 154/90, Pulse 76/min, resp normal. Within 30 minutes (2pm) client felt better, but start to itch, call 911 and sent to ER. Given epinephrine, Benadryl, Prednisone sent home after 2.5 hours.				Y					Y	11/18/2005	11/18/2005	0		PUB	PUB	Albuterol;Wellbutrin;Vendomet; Aricept;Micardis; Vitamins;Diabetic	NONE	Diabetes- blood sugar 153 at time of reaction			1						1	Asthenia; Feeling hot; Nausea; Pallor; Pruritus	FLU3~SANOFI PASTEUR~U1823AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249538	12/20/2005	RI	1.03	1	.0	M		2 x 1 both size cm erythema induration and vesiculation.										12/02/2005	12/14/2005	12		PUB	PUB		NONE	NONE			1						1	Blister; Erythema; Injection site induration	FLU3~SANOFI PASTEUR~U1787AA~UNK~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0236R~UNK~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0783R~1~~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0249539	12/20/2005	IL	69.0	69		F	12/09/2005	Patient developed swelling and pain of her entire RUE within hours of receiving the pneumococcal vaccine; described seeing 'hives' or 'welts' with severe pain, was unable to use the entire RUE.				Y					U	11/18/2005	11/18/2005	0	NONE	PUB	PUB	Procardia XL;Levaquin;Ibuprofen		Hypertension;Left shoulder lipoma;Adenomatous colonic polyps			1						1	Hypokinesia; Pain; Swelling; Urticaria	FLU3~SANOFI PASTEUR~U1858BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0741R~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0249543	12/20/2005	MD	64.0	64		M	12/20/2005	Fluzone/Influenza vaccine Aventis Lot U1764AA,administered 12/14/2005 by nurse at about 12:30 PM. By 7:00 PM non-productive, hacking cough, bad headache, painful joints and generally seeming like having the flu. Next day stayed home on sick leave, developed an ear ache (R), with very swollen lymph glands on neck, from in front of ears downward to side of neck, with right side still swollen and some tenderness as of 12/20/2005 (six days later). Other symptons have gradually reduced with headache gone after 3 days, general joint pain after 2-3 days, some coughing still continues, and right side of neck and ear tenderness still somewhat of concern.  In the CDC VAERS data review by vaccine type, mfg, lot, the lot for my flu vaccine had 11 entries, and ranked among the 10 lots for all entries. Of note, 4 entries were in uninterrupted sequence, with the remaining 7 in close sequence. I received this dose as a (left-over/remaining dose) late injection because I had been deployed for Hurricane Katrina and had taken other shots for that deployment in early September, and the shots were just made available on a limited basis. I am concerned if this is an allergic reaction that I need to discuss with my physician, a known side effect of the vaccines, or something more specific. Thanks.									U	12/14/2005	12/14/2005	0	None to date	UNK	UNK		None	general seasonal allergies Penn and demerol allergy			1						1	Arthralgia; Cough; Headache; Lymphadenopathy	FLU3~SANOFI PASTEUR~U1764AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249544	12/20/2005	MN	53.0	53		F	12/20/2005	Pain in arm with decrease in range of motion following flu shot lasting until present. Visit to primary MD, who ordered x ray (neg) and PT. Firt PT appt was 12/19/05, who started a course of exercises. Will see again in 2 weeks.									U	10/31/2005	11/01/2005	1	x ray	UNK	UNK	hydrochlorothiazide prempro	none	none			1						1	Hypokinesia; Pain	FLU3~SANOFI PASTEUR~1904AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249571	12/20/2005	OH	73.0	73		M	12/13/2005	Flu shot 10/13/05 had red rash with itching from above knees to head, arms, thighs and chest.  Saw Dr. 11/30/05 was treated wing methylprednisolone 4 mg packet for 7 days.  and Zyrtec 10mg 1x day for 10 days.  rash still present no difficulty breathing.  To follow up with Dr again or dermatologist.									U	10/13/2005	10/15/2005	2	CBC 11/30/05	OTH	OTH	Atendol 50mg 1x day, asprin 51mg 1x day, Dyazide 37 1x day, Tyrazosin 1x day 5mg	NONE	Bypass surgery 1990			1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0249576	12/20/2005	NM	1.25	1	.2	M	12/19/2005	Parents state knot appeared on right leg shortly after injection was given and area became reddened. Child taken to doctor who prescribed anti-itch cream. Parents returned with child to local health office after affected area began to worsen. Advised to return to doctor's office for prescription of antibiotics.				Y					Y	12/06/2005	12/06/2005	0	NONE	PUB	OTH	NONE	NONE	NONE			1						1	Erythema; Injection site induration	FLU3~SANOFI PASTEUR~U1765HA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249577	12/20/2005	CA	49.0	49		F	12/02/2005	11/29/05 5:00 pm feeling tired. Late that night vomited one time. 11/30/05 Achy body, tired, diarrhea, vomiting, diarrhea through the night to 12/1/05. 12/1/05 Tired, achy. 12/2/05 Sinusitis, Rhinitis. Not sprayed but dripped in when administered.									N	11/29/2005	11/29/2005	0	NONE	PUB	PUB	NONE	NONE	NONE		CA050086	1						1	Diarrhoea; Fatigue; Pain; Rhinitis; Sinusitis; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500392P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0249585	12/20/2005	FL				F	12/20/2005	Approximately 4 hours following the vaccine the employee was taken to the E.R. for an anaphylactic reaction. She developed hives and the sensation of her throat closing, 102.0 degree temperature, vomiting and body aches. Employee improved with treatment and returned to work within 2 days. A latex rast was performed and was negative.  No other information was provided.				Y					Y				A latex rast was performed and was negative.	UNK	UNK						1						1	Anaphylactic reaction; Pain; Pyrexia; Throat tightness; Urticaria; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA123AC~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0249588	12/20/2005	FL	0.0			U	12/20/2005	Approximately 2 hours after receiving the vaccine the employee broke out in hives with blisters. The hives progressed to multiple body parts. This employee was treated and was referred to an allergist for continued treatment.  A latex rast was performed and was negative.  The employee has remaining reddened areas but with treatment the itching has subsided. no further information was provided.				Y					U				A latex rast was performed and was negative.	UNK	UNK	UNK	UNK	UNK			1						1	Blister; Erythema; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA123AC~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0249589	12/20/2005	FL	0.0			U	12/20/2005	Employee developed hives on arms, trunk and legs.  She was treated by her personal doctor.				Y					U					UNK	UNK	UNK	UNK	UNK			1						1	Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA123AC~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0249590	12/20/2005	FL	0.0			U	12/20/2005	Documented arm swellings with pain and redness lasting more than 3 days. Untreated. This is the 1st of two such identical documented reports from this source-no other information was provided.									U					UNK	UNK	UNK	UNK	UNK			1						1	Erythema; Pain; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA123AC~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249591	12/20/2005	FL	0.0			U	12/20/2005	Documented arm swellings with pain and redness lasting more than 3 days. Untreated. This is the 2nd of two such identical documented reports from this source-no other information was provided.									U				not provided	UNK	UNK	UNK	UNK	UNK			1						1	Erythema; Pain; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA123AC~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249592	12/20/2005	FL	0.0			U	12/20/2005	Employee reports fever, chills muscle aches  felt like full blown flu This is the first of 2 such identical reports from this source.  No other information provided									U					UNK	UNK	UNK	UNK	UNK			1						1	Chills; Influenza like illness; Myalgia; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA123AC~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249593	12/20/2005	FL	0.0			U	12/20/2005	Employee reports fever, chills muscle aches  felt like full blown flu This is the second of 2 such identical reports from this source.  No other information provided									U				UNK	UNK	UNK	UNK	UNK	UNK			1						1	Chills; Influenza like illness; Myalgia; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA123AC~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249603	12/21/2005	WI	4.0	4		M		Shortly after immunizations, began sneezing and then complaining of abdominal pain. Then he began vomiting for about 45 minutes. Vomiting up thick clear phlegm. Also, developed a rash mainly over knees, elbows, stomach, hands, ears, chest, and on thighs where given injections. Became lethargic and non-responsive to voice. Admitted to PICU; given 30mg Solumedrol and a IVS bolus of 300ml.				Y	Y	1			Y	12/01/2005	12/01/2005	0		PVT	PVT		Had otitis media with congestion and cough 1 week ago.	History of penile chordee, congenital phimosis and penile scrotal encroachment at 9 months.			1						1	Abdominal pain; Coma; Lethargy; Rash; Sneezing; Vomiting	DTAP~UNKNOWN MANUFACTURER~~UNK~~~DTAP (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Hospitalisation	Influenza
0249604	12/21/2005	AZ	45.0	44		M	12/16/2005	Itch trunk area since Wednesday 12-14-05 (raised rash back,  and stomach area)									Y	12/12/2005	12/14/2005	2		OTH	OTH	NONE	Healthy	Smoker			1						1	Pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~U1871BA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249605	12/21/2005	WI	4.0	3		F	12/14/2005	C/O chills, headache, fever 102.6 degrees F, lethargic, diarrhea times 1. Headache with 1st flu shot. Denies nausea and vomiting. Brother c/o viral infection 1 wk ago. 12/16/05 Pt getting better fever broke.									Y	12/13/2005	12/13/2005	0		PUB	PUB	FL tablets					1						1	Chills; Diarrhoea; Headache; Lethargy; Pyrexia	FLU3~SANOFI PASTEUR~U1787~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249606	12/21/2005	TX	41.0	41		F	11/14/2005	Patient received the influenza vaccine on Thursday, 11-3-05. That evening she developed a rash on her back. She took Benadryl. The rash cleared up but returned on her neck and face the next day. She continued to take Benadryl. The rash spread to her arms and legs and was gone by Monday.									Y	11/03/2005	11/03/2005	0		OTH	UNK		NONE	NONE			1						1	Rash	FLU3~SANOFI PASTEUR~U1755AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249617	12/21/2005	IN	83.0	83		M	12/21/2005	My father received a flu vaccination from his doctor on Dec. 6, 2005. The next day, he began experiencing dizzy spells that continued to worsen. We thought he might have an inner ear infection, so he made an appointment with his doctor for Dec. 16, 2005. The doctor could find no infection. That night, Dec. 16, 2005, my father got up in the middle of the night and was very dizzy, and he fell and hit the back of his head, which caused subarachnoid bleeding in his brain. He did not realize he had fallen, so he did not call anyone or go to the hospital. The next evening, Dec. 17, 2005, he had seizures and had to be rushed to the hospital, where he is still a patient. I spoke with his neurologist last night at the hospital and he said he thinks my father had a stroke on Dec. 7, 2005, the day after he received the flu shot, and that the dizziness caused by the stroke caused him to fall and injure himself. Because the stroke happened the day after he received the flu shot, I'm very concerned the vaccine may have caused the stroke. Information received from the 60 day follow-up stated he became dizzy and suffered a light stroke two days after getting the shot, then fell and hit his head on December 16. From that, he suffered a subdural hematoma that required a borehole drilled, then later a craniotomy. He did not recover from that and passed away January 31, 2006			Y	Y	Y			Y	N	12/06/2005			He is in the hospital now.	UNK	UNK		No				1						1	Cerebrovascular accident; Craniotomy; Dizziness; Fall; Haemorrhage intracranial; Injury; Subdural haematoma	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0249621	12/21/2005	MO	25.0	24		F	12/21/2005	Patient presented on 12-21-05  11:35am complaining of continued pain in right shoulder area from Fluvirin injection received on 12-3-05. She also mentioned a decreased range of motion in the right shoulder area.									U	12/03/2005	12/21/2005	18		UNK	UNK		none	none			1						1	Joint range of motion decreased; Shoulder pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62445~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0249623	12/21/2005	AL	17.0	17		M	12/21/2005	9x9cm diameter area at the injection site that is red, hot, painful, tender, and swollen/fluctulant. Started on Keflex, presumed cellulitis.									U	12/19/2005	12/21/2005	2		MIL	MIL	none	none	none			1						1	Cellulitis; Injection site erythema; Injection site pain; Injection site reaction; Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~SYR~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0249624	12/21/2005	CA	45.0	45		F	12/21/2005	The injection hurt. The arm continued to be painful, without redness or swelling. Have had some numbness ang tingling. Arm continues to have a dull pain making it hard to move and do things like getting dressed.  About a week and a half after the flu shot got a sore throat and laryngitis.  At that time the arm started to flare up and get painful again. Went to the doctor for the sore throat and mentioned the arm. He felt the shot had made her fibromyalgia flare and that it should be reported to VAERS.				Y					U	11/29/2005	11/29/2005	0		UNK	UNK	Estrogen replacement, Calcium suppliments, Ametriptiline, Fosxame	Had just recovered from a viral infection that had her achy and fatigued. History of Fibromyalgia.	Fibromyalgia			1						1	Condition aggravated; Fibromyalgia; Hypoaesthesia; Hypokinesia; Injection site pain; Joint range of motion decreased; Pain; Paraesthesia; Pharyngolaryngeal pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62447~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0249635	12/21/2005	MA	45.0	45		F	12/19/2005	Gave vaccine early afternoon. Around 5 pm, developed wheezing, watery nose and tongue felt funny. Between 6-7 pm, lower jaw, lower lip and tongue felt numb. Wheezing got worse. Took benadryl 25 mg. Wheezing improved. Went to er and received pepcid. Took more benadryl and pepcid at midnight and symptoms resolved next day.				Y					Y	11/21/2005	11/21/2005	0		OTH	PUB	lorapepam		depreeion, anxiety, fibromyalgia			1						1	Hypoaesthesia; Rhinorrhoea; Wheezing	FLU3~SANOFI PASTEUR~U1872AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249636	12/21/2005	MA	5.0	5		M	12/13/2005	Left arm red, warm,. swollen at injection site. 10 x 10 cm. Cellulitis. Tx with Keflex.										12/12/2005	12/13/2005	1		PVT	UNK		NONE		redness~Influenza (Seasonal) (no brand name)~1~4.00~In Patient		1						1	Cellulitis; Injection site erythema; Injection site swelling	DTAP~SANOFI PASTEUR~U1344DA~4~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U12872AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0248~4~SC~LA~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~1072P~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0249637	12/21/2005	CO	34.0	34		F	12/12/2005	Patient was given 0.5 ml of vaccine. She took the vaccine well but 10 seconds later patient complained that she did not feel well. She then lost consciousness and fell right of the chair. She awoke 30 seconds later with no memory of the event.				Y					Y	12/09/2005	12/09/2005	0	BP 110/80;HR :70	OTH	OTH	Celexa 40 mg;Ortho Tri-Cyclen	NONE	NONE			1						1	Loss of consciousness; Malaise; Memory impairment	FLU3~SANOFI PASTEUR~U1816AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249640	12/22/2005	NC	46.0	45		F	12/08/2005	Erythema, induration, tenderness at injection site left deltoid, left upper arm. No fever. Symptoms resolved after 5-7 days.									Y	11/10/2005	11/11/2005	1		PVT	UNK	lexapro, xanax, omeprazole, hydrocodone, flexerill		Hepatitis C virus infection, depression			1						1	Injection site erythema; Injection site induration; Tenderness	FLU3~SANOFI PASTEUR~U1777A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1046P~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249641	12/22/2005	ND	34.0	33		F	11/22/2005	Neck and headache, chill, diaphoresis, flank pain, chest pain. Symptoms last every night. Mild headache now.									Y	11/21/2005	11/21/2005	0	CBG normal except # segs 78;bands 2;Lymph 7;UA neg.	PVT	OTH	Depo Provera;Lexapro	NONE	NONE		ND0512	1						1	Chest pain; Chills; Flank pain; Headache; Hyperhidrosis; Neck pain	FLU3~SANOFI PASTEUR~U1881AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249646	12/22/2005	IN	1.2	1	.2	M	12/19/2005	Physician ordered Prevnar. Patient given pneumovax.									Y	11/23/2005	11/23/2005	0		PVT	PUB						1						1	Medication error	FLU3~SANOFI PASTEUR~U1765FA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0301R~1~~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PPV~MERCK & CO. INC.~1006P~1~~LL~PNEUMO (PNEUMOVAX)~1|VARCEL~MERCK & CO. INC.~0120R~1~~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0249647	12/22/2005	VA	1.02	1	.0	F	12/21/2005	Morbilliform rash on trunk same on upper extremities, low grade fever.									Y	12/12/2005	12/20/2005	8	NONE	PVT	PVT		NONE	NONE			1						1	Rash morbilliform	FLU3~SANOFI PASTEUR~U1787FA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0484R~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0069R~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0249650	12/22/2005	GA	44.0	44		M	12/22/2005	Vaccine given on 11/16/05 at about 11:30 AM: 9 hours after receiving the shot: hot flashes, muscle aches, cold sweats: lasting for two days. Then on 11/21/05 5 days after the vaccine: cold sweats, low grade fever, insomnia, chest pains - as if a great weight was on the chest, back pains between the shoulder blades, body aches, trouble breathing. 11/22/05 8:30 AM - went to the clinic - low oxygen in blood, blood in urine, high white and red blood count, low grade fever, body aches, back pain, chest pain. Ambulanced to hospital: Arrived about 11:30AM given oral and IV MEDS, heart monitor, nitroglycerin ointment 2% 1GM, Troponin I, Magnesium, Promethazine HCL, Sod Chloride 0.9%, Cenftriaxone Injection, Morphine injection, Lopressor 50 mg, Aceta tablets 325 mg, Darvon 100 mg, Ambien 5mg, Plavix 75mg, Hum R Per unit, Diovvan HT 160/12.5, Pantoprazole 40mgp, Travenol, Insulin Glargine, zoccar 80mg, oxygen, admitted to the hospital, continued observation, heart monitoring, antibiotics, Discharged on 11/24/05 at 2:30 PM ordered to take CEFUROXIME AXETIL antibiotics 500 mg two times daily for ten days. On 11/25/05 10:00 am the right arm began to hurt, swelling, and hot to the touch. Pain got worst till swelling got very bad. 11/30/2005 8:00 AM saw my Cardiologistist to review what happened at the hospital and told him of the pain in the arm. He dignosied it as a staff infection and told me to continue to take the medication hospital assigned but if it got worst to go back to the hospital. On 12/01/05 went back to the hospital a blood clot was found and infection in my arm: treatment included Enoxaparin, saline flush 10ml, Sod Chloride 0.9%, Septra Ds Tablet, Ceftriaxone injection: Oral medication included Augmentin, Bactrim DS, Motrin, Vicodin. On 12/03/05 4:00 pm began to feel clammy, hot with cold sweats but no fever and was gone the next day. Have been healthy since.				Y	Y	3			Y	11/16/2005	11/16/2005	0	blood, urine, EKG.	UNK	UNK	Potassium Gluconate, Nexium 40mg, Glucophage 100mg 2Xs daily, Plavix 75mg, Toprol XL 200mg, Zocor 80mg, Diovan HCT 2Xs 160mg/12.5mg, Advanced Formula Complete vitamine tablet.	None	Allergy - Asprine: Medical Condition i Leaky Arotic Heart valve, Type II Sugar Diabites, High Blood pressure, Irritable Bowl Syndrome.	None~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Back pain; Bacterial infection; Blood urine; Chest pain; Cold sweat; Dyspnoea; Hot flush; Hyperhidrosis; Injection site warmth; Insomnia; Myalgia; Pain; Pyrexia; Red blood cell abnormality; Swelling; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0249662	12/22/2005	OH	38.0	37		F	12/22/2005	4 hours after vaccination:  foreign body sensation in throat, dry cough 6 hours after vaccination:  fatigue, low-grade fever (temperature not taken), uncontrollable chills/rigors, muscle aches (entire body), injected eyes (bloodshot) 7 hours after vaccination:  Treatment with Advil 400 mg 2 hours after Advil:  improvement in symptoms 8 hours after Advil:  further improvement except for tiredness									Y	12/21/2005	12/21/2005	0	None	UNK	UNK	multivitamins	None	None			1						1	Chills; Cough; Fatigue; Myalgia; Ocular hyperaemia; Pyrexia; Throat tightness	FLU3~SANOFI PASTEUR~u1830aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249666	12/22/2005	ND	37.0	36		F	12/22/2005	Received both the influenza vaccine and the new pertussis/diphtheria/tetanus in my right deltoid.  My arm swelled up the next day and developed a mild cellulitis.									Y	12/19/2005	12/20/2005	1		UNK	UNK		None	None			1						1	Cellulitis; Swelling	DTAP~PFIZER\WYETH~~1~IM~RA~DTAP (ACEL-IMUNE)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~~5~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249667	12/22/2005	VA	9.0	8		M	12/22/2005	Patient received 0.5 cc Fluarix vaccination IM; this is not approved by the FDA for use in children younger than 18 years.  No apparent side effects.									Y	11/19/2005	11/19/2005	0		UNK	UNK	Unknown	N/A	Unknown			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU141BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249668	12/22/2005	VA	7.0	6		M	12/22/2005	Patient received Fluarix vaccination - this is not approved for those under age 18. No adverse reactions reported by Mom.									Y	11/19/2005	11/19/2005	0		UNK	UNK	Unknown	N/A	Unknown			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU1413BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249669	12/22/2005	VA	6.0			F	12/22/2005	Patient received Fluarix vaccine, which is not approved for children under age 18.  No adverse reactions reported by Mom.									Y				N/A	UNK	UNK	Unknown	N/A	Unknown			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU141BA~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249670	12/22/2005	VA	9.0	9		M	12/22/2005	Patient received Flurarix vaccine, which is only approved for those over age 18; no adverse reactions reported by Mother.									Y	11/19/2005	11/19/2005	0	N/A	UNK	UNK	Unknown	N/A	Unknown			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU141BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249671	12/22/2005	VA	11.0	11		F	12/22/2005	Patient received Fluarix vaccine, which is not approved for children under age 18.  No adverse reactions according to Mom.									Y	11/19/2005	11/19/2005	0	N/A	UNK	UNK	Unknown	N/A	Unknown			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU141BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249672	12/22/2005	VA	16.0	15		F	12/22/2005	Patient received Fluarix vaccine, which is not approved for children under age 18.  No apparent side effects according to mom.									Y	11/19/2005	11/19/2005	0	N/A	UNK	UNK	Unknown	N/A	Unknown			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU141BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249673	12/22/2005	VA	17.0	17		F	12/22/2005	Patient received Fluarix vaccine, which is not approved for those under age 18.  No apparent side effects according to Mom.									Y	11/19/2005	11/19/2005	0	N/A	UNK	UNK	Unknown	N/A	Unknown			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU141BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249674	12/22/2005	VA	16.0	16		M	12/22/2005	Patient received Fluarix vaccine, which is not approved for those under age 18.									Y	11/19/2005	11/19/2005	0	N/A	UNK	UNK	Unknown	N/A	Unknown			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU141BA~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249675	12/22/2005	VA	17.0	17		M	12/22/2005	Patient received Fluarix vaccine, which is not approved for use in those under age 18. No adverse reactions according to Mom.									Y	11/19/2005	11/19/2005	0	N/A	UNK	UNK	Unknown	N/A	Unknown			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA141BA~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249676	12/22/2005	VA	17.0	17		M	12/22/2005	Patient received Fluarix vaccine, which is not approved for children under the age of 18.  Mom reports no adverse reaction.									Y	11/19/2005	11/19/2005	0	N/A	UNK	UNK	Unknown	N/A	Unknown			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA141BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249663	12/23/2005	VA	72.0	72		F	12/23/2005	Received the flu 2 weeks after the shot then it turned pneumonia. 2/21/06 Received medical records which revealed patient experienced acute respiratory failure, pneumonia, CHF, hypernatremia, azotemia, HTN, MRSA pneumonia & MRSA UTI.  PMH: hypercholesterolemia, osteoporosis, compression fx, liver cyst, hypothyroidism & hyperlipidemia./ss							Y		N	10/24/2005	11/24/2005	31	chest x ray, blood work, ventilator MRSA pneumonia MRSA UTI	UNK	UNK		none	high blood pressure, thyroid			1						1	Azotaemia; Cardiac failure congestive; Hypercholesterolaemia; Hyperlipidaemia; Hypernatraemia; Hypertension; Hypothyroidism; Osteoporosis; Pneumonia; Respiratory failure; Urinary tract infection	FLU3~PFIZER\WYETH~~UNK~~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation	Influenza
0249664	12/24/2005	OH	0.34	0	.3	M	12/24/2005	At 2mths routine vax.. approx 1 hr after started having unconsolible screaming.. Was fussy/crabby for approx 2wks after. At 3mth routine vax. Pertussis vax was eliminated. Approx 1 hr after started having inconsolable crying.. Tylenol was administered after each vax approx every 4 hours.									Y	12/05/2005	12/05/2005	0		UNK	UNK		None	none			1						1	Agitation; Irritability; Screaming	DTAPH~UNKNOWN MANUFACTURER~~2~SC~LL~DTAP + HIB (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~SC~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0249665	12/26/2005	TX	28.0	27		M	12/26/2005	My arm hasn't stopped hurting since my shot.  I have about 50% strength in that arm and when I move my shoulder beyond certain angles I feel like someone is stabbing me.  The pain has caused me to awake in the middle of the night on several occassions.  My friend is a doctor and he told me that they a nerve was probably hit.  That it would just take time, I told him that was unacceptable.  What if I have permanent nerve damage in my arm?									N	11/10/2005	11/10/2005	0		UNK	UNK		None	N/A			1						1	Pain; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0249685	12/26/2005	MI	50.0	49		F	12/26/2005	FLU VACCINE RECEIVED AT PLACE OF EMPLOYMENT.  ACTUAL INJECTION WS NON-EVENTFUL HOWEVER, THE ADMINSTRATION OF THE VACCINATION MEDICATION WAS QUITE PAINFUL.  APPROXIMATELY TWO (2) HOURS AFTER INJECTION ARM STARTED BECOMING QUITE SORE.  HAVING RECEIVED FLU VACCINATIONS YEARLY FOR MANY YEARS, IT WAS NOT UNUSUAL TO EXPERIENCE SOME TENDERNESS IN THE HOURS AFTER THE INJECTION. THAT EVENING, I EXPERIENCED EXTREME PAIN IN THE ARM AND WAS BARELY ABLE TO MOVE IT.  THIS CONTINUED THROUGHOUT THE NIGHT KEEPING ME AWAKE MOST OF THE NIGHT.  AFTER A FEW DAYS IT DAYS IT WAS FEELING BETTER.  A LITTLE SORE BUT NOTHING SEVERE SO I ASSUMED MY ARM WAS RECOVERING.  HOWEVER, JUST AS I THOUGHT IT WAS IMPROVING, THE PAIN AGAIN BECAME QUITE SEVERE (THIS OCCURRED APPROX SEVEN (7) DAYS AFTER THE INJECTION.  OVER THE FOLLOWING WEEKS, THE LEVEL OF PAIN FLUCTUATED BETWEEN MILD (TOLERABLE) AND SEVERE (MOVEMENT CAUSED ME TO GASP).  ON DECEMBER 14, 2005, I VISITED MY PRIMARY CARE PHYSICIAN.  HE TOLD ME HE FELT THAT THE SYMPTOMS WERE NOT CAUSED BY NEEDLE, BUT DIAGNOSED IT AS A NEURITIS CAUSED BY THE VACCINE.  HE PRESCRIBED NEUROTININ (GABAPENTIN 300 MG TWICE DAILY FOR TWO WEEKS).  I WAS UNABLE TO CONTINUE WITH THAT TREATMENT BECAUSE IT CAUSED SEVERE DIARRHEA AND GAS.  I HAVE AN APPOINTMENT SCHEDULED WITH AN ORTHOPAEDIC SPECIALIST FOR DECEMBER 30, 2005.				Y					N	11/18/2005	11/18/2005	0	NONE AT THIS TIME.	UNK	UNK	SYNTHROID ZOLOFT	NONE.	HASHIMOTO THYROIDITIS.			1						1	Diarrhoea; Hypokinesia; Injection site pain; Neuritis; Pain; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA151AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0249419	12/27/2005	IA	66.0			F	12/27/2005	This citizen sent a letter to her local health department on December 13th to report this AE. The letter was also sent to CDC OD on December 14th and the letter was then forwarded to this reporter who is entering the information on behalf of this citizen, whom i spoke with on the phone today.  The letter and today's phone conversation both involve the citizen describing severe pain upon movement and loss of mobility in the left arm.  The arm pain extends from the left shoulder and neck down to the wrist area and also involves numbness and tingling of the middle finger.  She now also reports feeling small lumps at the injection site.  She is beginning physical therapy at 2PM on 12/27/05.  I asked her for permission to fill out this report on her behalf. I also told her that she would be receiving a follow-up letter from the VAERS system which would ask her if her symptoms had resolved.  I have given her my phone number to contact me directly if she desires to contact me to discuss.				Y				Y	N	11/09/2005	11/10/2005	1		UNK	UNK	insulin injeciton and also oral medicaltion for diabetes	none	diabetic for past 16 years			1						2	Hypoaesthesia; Injection site mass; Injection site pain; Paraesthesia; Hypoaesthesia; Hypokinesia; Injection site mass; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U1849AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Disabling	Influenza
0249686	12/27/2005	CA				U	12/07/2005	This case was reported by a healthcare professional and described the occurrence of flu like symptoms in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The healthcare professional reported that four adults experienced  flu like symptoms following administration of Fluarix, however, subject identifiers were not reported. On an unspecified date on or after 01 September 2005 and on or before 16 September 2005, the subject received 1st dose of Fluarix (lot number not provided). On an unspecified date on or before 16 September 2005, less than one week after vaccination with Fluarix, the subject experienced flu like symptoms, upset stomach, lightheadedness, dizziness, and chills. At the time of initial reporting, 16 September 2005, the events were ongoing.									N	09/01/2005	09/01/2005	0	UNK	OTH	OTH		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported.		A0574648A	1						1	Chills; Dizziness; Influenza like illness; Stomach discomfort	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249687	12/27/2005	MD	78.0	77		F	12/07/2005	This case was reported by a nurse and described the occurrence of a needle stick injury in a 77 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. Follow-up was received by an office manager. There were no concurrent medications. On 03 October 2005 the subject received 1st dose of Fluarix in an unspecified arm. The nurse reported that she, attached a 25 gauge, 5/8 inch needle to the prefilled syringe of Fluarix. Upon pulling back on the dose, the needle released form the hub of the syringe and stayed in the patient's arm. The needle did not break. The subject was taken to the emergency room. At the emergency room, a specialist was called in and had to make a cut to remove the needle from the subject's arm. The procedure was completed in the emergency room and the subject was discharged from the emergency room on the same day. It was not reported if the subject received any of the Fluarix. The event was ongoing at the time of follow-up reporting, 25 October 2005. The office manager reported that it was determined that the incident was caused by a fault with the needle, not any problem with the Fluarix syringe.				Y					N	10/03/2005	10/03/2005	0	UNK	PVT	PVT	No concurrent medication	UNK	The subject's medical history and concurrent conditions were not reported.		A0576823A	1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0249688	12/27/2005	TX	38.0	37		F	12/07/2005	This case was reported by a nurse and described the occurrence of chest tightness in a 37 year old female subject who was accidentally exposed to influenza virus vaccine (Fluarix) for prophylaxis. The reporter is the subject. Medical history included a severe egg allergy. The nurse also reported that she is not latex sensitive. On 03 October 2005 the subject was removing a label from a used Fluarix viral. She reported that she did not use gloves when handling the vaccine. Within minutes on 03 October 2005, the subject noticed that her mouth and lips were itching and she was coughing. Later that day, on 03 October 2005, the subject administered a Fluarix dose to a patient and she noticed the same symptoms. On 03 October 2005, the subject took a desloratadine (Clarinex) and within 30 minutes, the events resolved. On 04 October 2005, the subject was again accidentally exposed to Fluarix when a small drop of the vaccine was expelled from a syringe. Shortly after the accidental exposure to Fluarix, on 04 October 2005, the subject again experienced itching of the mouth and lips, coughing and slight chest tightness. The subject state that, these symptoms never happened when she administered Fluzone (influenza virus vaccine).										10/04/2005	10/04/2005	0	UNK	OTH	OTH		UNK	Egg Allergy  The subject reported that she is not latex sensitive. The subject's concurrent conditions and concurrent medications were not reported.	This subject was accidentally exposed to Fluarix on 03 October 2005 and experienced itching and coughing.~Influenza (Seasonal) (	A0577064A	1						1	Chest discomfort; Cough; Medication error; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~2~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249689	12/27/2005					M	12/07/2005	This case was reported by a healthcare professional and described the occurrence of generalized rash in an adult male subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The subject is a physician. On 05 October 2005 the subject received 1st dose of Fluarix. At an unspecified time following the administration of Fluarix, on 05 October 2005, the subject experienced a generalized rash. The generalized rash resolved on an unspecified date on or after 05 October 2005 and on or before 07 October 2005.										10/05/2005	10/05/2005	0	UNK	OTH	OTH		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported.		A0577439A	1						1	Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249690	12/27/2005		12.0			U	12/07/2005	This case was reported by a nurse and described the occurrence of injection site soreness in a 12 year old subject of unspecified gender who was inadvertently vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The reporter is the mother of the subject. On an unspecified date in 2005, on or before 14 October 2005, the subject received 1st dose of Fluarix at an unspecified site of administration (lot number not provided). Fluarix is recommended for immunizing individuals 18 years of age and older. At an unspecified time following the administration of Fluarix, on or before 14 October 2005, the subject experienced injection site soreness. At the time of reporting 14 October 2005, the outcome of the injection site soreness was not provided. Follow-up to the case will not be available.									U				UNK	OTH	OTH		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported. The nurse reported that the subject's sibling also inadvertently received Fluarix and experienced injection site soreness. Please see case A0578343A	This vaccinee's sibling experienced soreness at the injection site following receipt of Fluarix~Influenza (Seasonal) (Fluarix)~~	A0578342A	1						1	Injection site reaction; Myalgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249691	12/27/2005		14.0			U	12/07/2005	This case was reported by a nurse and described the occurrence of injection site soreness in a 14 year old subject of unspecified gender who was inadvertently vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The reporter is the mother of the subject. On an unspecified date in 2005, on or before 14 October 2005, the subject received 1st dose of Fluarix at an unspecified site of administration (lot number not provided). Fluarix is recommended for immunizing individuals 18 years of age and older. At an unspecified time following the administration of Fluarix, on or before 14 October 2005, the subject experienced injection site soreness. At the time of reporting, 14 October 2005, the outcome of the injection site soreness was not provided. Follow-up to the case will not be available.									U				UNK	OTH	OTH		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported. The nurse reported that the subject's sibling also inadvertently received Fluarix and experienced injection site soreness. Please see case A0578342A.	This vaccinee's sibling experienced soreness at the injection site following receipt of Fluarix~Influenza (Seasonal) (Fluarix)~~	A0578343A	1						1	Injection site reaction; Medication error; Myalgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249692	12/27/2005	WI	54.0	53		F	12/07/2005	This case was reported by a nurse and described the occurrence of dizziness to a 53 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On 28 October 2005 the subject received 1st dose of Fluarix in the left arm (lot AFLUA151BA). Approximately 20 minutes after receiving Fluarix, on 28 October 2005, the subject experienced dizziness, nausea, and felt like fainting. The subject was seen at a physician's office. The events had improved as of the time of initial reporting 28 October 2005. The nurse considered the events to possibly be related to vaccination with Fluarix.				Y					N	10/28/2005	10/28/2005	0	UNK	PUB	PUB		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported. The nurse reported that one other subject experienced adverse events following receipt of Fluarix from lot AFLUA151BA. Please see case A0580144A.		A0580143A	1						1	Dizziness; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA151BA~1~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0249693	12/27/2005	WI	43.0	42		F	12/07/2005	This case was reported by a nurse and described the occurrence of vomiting in a 42 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On 28 October 2005 the subject received 1st dose of Fluarix in the right arm (lot AFLUA151BA). At an unspecified time following receipt of Fluarix, on 28 October 2005, the subject experienced vomiting and nausea. The subject rested at home. The events were ongoing at the time of initial reporting, 28 October 2005. The nurse considered the events to possibly be related to vaccination with Fluarix.									N	10/28/2005	10/28/2005	0	UNK	PUB	PUB		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported. The nurse reported that one other subject experienced adverse events following of Fluarix from lot AFLUA151BA. Please see case A0580143A.		A0580144A	1						1	Nausea; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA151BA~1~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249694	12/27/2005	IL	50.0			F	12/07/2005	This case reported by a pharmacist and described the occurrence of shingles in a 50 year old female subject who was vaccinated with influenza virus vaccine for prophylaxis. On 10/20/05 the subject received a dose of Fluarix. The pharmacist reported that the suject received influenza virus vaccine, in the past without incident. At an unspecified time following the administration of Fluarix, on 10/20/05, the subject did not feel well. The subject was seen at a physician's office on 10/21/05 and was diagnosed with shingles. The subject was treated with anti-viral medication. The events had improved as of the time of initial reporting. 10/05 the pharmacist considered the events to possibly be related to vaccination with fluarix. On follow up received 11/22/05, the pharmacist reported the events had resolved with treatment unspecified anti-viral medication. The pharacist considered the events to be unrelated to vaccination with Fluarix.				Y					Y	10/20/2005	10/20/2005	0		OTH	PVT					A0580342A	1						1	Feeling abnormal; Herpes zoster	FLU3~GLAXOSMITHKLINE BIOLOGICALS~120AA~2~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0249695	12/27/2005	NY				F	12/07/2005	This case was reported by a nurse and described the occurrence of itchy rash in a female subject of unspecified age who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date in 2005, on or before 04 November 2005, the subject received 1st dose of Fluarix (lot AFLUA154BA). At an unspecified time after vaccination with Fluarix, on or before 04 November 2005, the subject experienced a generalized itchy rash. The subject was seen at a physician's office. The outcome of the event was not reported.				Y					U				UNK	OTH	OTH		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported.		A0581031A	1						1	Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA154BA~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0249696	12/27/2005					F	12/07/2005	This case was reported by a consumer and described the occurrence of viral illness in an adult female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The reporter is the subject. A physician or other health care professional has not verified this report. On 02 November 2005 the subject received a dose of Fluarix. The subject did not provide information regarding previous immunization with influenza virus vaccine. On an unspecified date on or before 08 November 2005, within days of vaccination with Fluarix, the subject experienced tiredness On 06 November 2005, she experienced swollen glands and difficulty swallowing. On an unspecified date on or before 08 November 2005, the subject was seen at a physician's office. The subject reported that the physician told that she had, a non-specific viral illness. The swollen glands and difficulty swallowing resolved on or after 06 November 2005 and on or before 08 November 2005. The viral illness and tiredness were ongoing at the time of initial reporting, 08 November 2005. Follow-up will not be available.				Y					N	11/02/2005			UNK	OTH	OTH		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported.		A0581486A	1						1	Dysphagia; Fatigue; Lymphadenopathy; Viral infection	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0249697	12/27/2005	VA	57.0	57		F	12/07/2005	This case was reported by a nurse and described the occurrence of injection site pain in a 57 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. There were no concurrent medications. On 28 October 2005 the subject received a dose of Fluarix in the left deltoid (lot AFLUA131BA). The nurse reported that the subject, had been getting her flu vaccine in previous years and never reacted to the flu shot like she did with Fluarix. On 28 October 2005, less than one day after vaccination with Fluarix, the subject experienced injection site pain in the left arm. The nurse reported that, on 29 October 2005, within 24 hours of injection' of Fluarix, the pain went to her left arm, then to the neck, and subsequently to the right side of the body. The pain was so severe that the patient could not lift her left arm up. Approximately five days after injection of Fluarix, on 02 November 2005, the subject was seen at a physician's office to treat a sinus infection. At the time of initial reporting the events were improved. The nurse considered the sinus infection to be unrelated and all the other events to probably be related to vaccination with Fluarix.				Y					N	10/28/2005	10/28/2005	0	UNK	PUB	OTH	No concurrent medication	UKN	The subject had no pre-existing medical conditions. The subject's concurrent conditions were not reported.		A0581493A	1						1	Hypokinesia; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA131BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0249698	12/27/2005	WA	48.0	48		F	12/07/2005	This case was reported by a nurse to a sales representative and described the occurrence of arm pain at the injection site in a 48 year old female subject who was vaccinated with influenza virus vaccine for prophylaxis. On 10/26/05, the subject received the first dose of Fluarix. Information regarding previous immunization with influenza virus vaccine was not provided. On 10/26/05, at an unspecified time after vaccination with Fluarix, the subject experienced arm pain at the injection site. As of 11/10/05, the event remained unresolved. In the reporting nurse's opinion, the event was probably related to vaccination with Fluarix.  At the time of follow-up reporting, December 19, 2005, the event had improved. In the nurse's opinion, the event was related to vaccination with Fluarix. The nurse also reported that the injection of Fluarix was possibly administered too high.									N	10/26/2005	10/26/2005	0		PUB	PVT		The subject's concurrent conditions and concurrent medications were not reported. The nurse reported that two additional subjects experienced arm pain at the injection site following the administration of Fluarix. (See A0581512A and A0581848A).	Shoulder Surgery.		A0581510A	1						1	Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~154AA~1~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249699	12/27/2005	WA	49.0	49		F	12/07/2005	This case was reported by a nurse to a sales representative and described the occurrence of arm pain at the injection site in a 49 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On 25 October 2005, the subject received the first dose of Fluarix (lot AFLUA154AA). Information regarding previous immunization with influenza virus vaccine was not provided. One day later, on 26 October 2005, the subject experienced arm pain at the injection site. As of 10 November 2005, the event remained unresolved. In the reporting nurse's opinion, the event was probably related to vaccination with Fluarix. The nurse also reported the injection of Fluarix was possibly administered too high.									N	10/25/2005	10/25/2005	0	On an unspecified date in 2005, after October 25, 2005, the subject's shoulder was x-rayed. The results of the x-ray were not provided.	PUB	PVT		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported. The nurse reported two additional subjects who experienced arm pain at the injection site following the administration of Fluarix. (See A0581510A and A0581848A)		A0581512A	1						1	Injection site pain; Vaccination complication; X-ray limb	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA154AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249700	12/27/2005	KY				U	12/07/2005	This case was reported by a pharmacist and described the occurrence of raised area injection site in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The pharmacist reported that, 50 percent of the patients, experienced a raised area at the injection site, however, a specific number of subjects was not provided. On an unspecified date in 2005, on or before 09 November 2005, the subject received a dose of Fluarix (lot AFLUA148BA). Information regarding previous immunization with influenza virus vaccine was not provided. At an unspecified time following vaccination with Fluarix, on or before 09 November 2005, the subject experienced a red, raised area at the injection site. The subject was taken to the emergency room. The outcome of the injection site reaction was not provided. The pharmacist considered the injection site reaction to probably be related to vaccination with Fluarix.				Y					U				UNK	PVT	PVT		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported.		A0581626A	1						1	Erythema; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA148BA~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0249701	12/27/2005	PA	37.0	36		F	12/07/2005	This case was reported by a nurse and described the occurrence of chest heaviness in a 36 year old female subject who was vaccinated with influenza virus vaccine for prophyylaxis. On 11/07/2005 at 1:05 pm, the subject received 1st dose of Fluarix in the left deltoid. On 11/07/2005 at 1:10 pm, 5 minutes after vaccination with Fluarix, the subject experienced chest heaviness, tingling body and headache. At 1:10 pm, the subject's blood pressure was 104/70 mm Hg, heart rate was 80 and respiratory rate was 14. The subject was observed for 1/2 hour. At approximately 1:40 pm on 11/07/05, the chest heaviness and body tingling resolved, blood pressure was 108/70 mm Hg, heart rate was 76, respiratory rate was 12 and temperature was 98.2  degrees F. The headache lasted for 4 hours and resolved at approximately 5:10 pm on 11/07/05.									Y	11/07/2005	11/07/2005	0		OTH	OTH					A0581681A	1						1	Chest pain; Headache; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~120AA~1~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249702	12/27/2005					U	12/07/2005	This case was reported by a pharmacist to a sales representative and described the occurrence of injection site irritation in an elderly subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date in 2005 on or before 10 November 2005, the subject received a dose of Fluarix (lot number not provided). Information regarding previous immunization with influenza virus vaccine was not provided. At an unspecified time following the administration of Fluarix, on or before 10 November 2005, the subject experienced injection site irritation that required a trip to the emergency room. The outcome of the injection site irritation was not reported.				Y					U				UNK	OTH	OTH		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported.		A0581701A	1						1	Injection site reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0249703	12/27/2005	WA	54.0			F	12/07/2005	This case was reported by a nurse to a sales representative and described the occurrence of arm pain at the injection site in a 54 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On 25 October 2005, the subject received the first dose of Fluarix (lot AFLUA154AA). Information regarding previous immunization with influenza virus vaccine was not provided. One day later, on 26 October 2005, the subject experienced arm pain at the injection site. As of 10 November 2005, the event remained unresolved. In the reporting nurse's opinion, the event was probably related to vaccination with Fluarix. Follow up - This case was reported by a nurse and described the occurrence of arm pain at the injection site in a 54-year-old female subject who was vaccinated with FLUARIX, GlaxoSmithKline. On 25 October 2005, the subject received a dose of FLUARIX in the right arm (lot AFLUA154AA). Information regarding previous immunization with influenza viruenza virus vaccine was not provided. At an unspecified time following the administration of FLUARIX. On 25 October 2005, the patient experienced arm pain at the injection site. The subject was seen at a physician's office. On an unspecified date in 2005, after 25 October 2005, the subject underwent a CT scan and ultrasound. The results of these tests were not provided. The event was ongoing as of 19 December 2005. In the reporting nurse's opinion, the event was probably related to vaccination with FLUARIX. The nurse also reported that the injection of FLUARIX was possibly administered too high.				Y					N	10/25/2005	10/25/2005	0	On an unspecified date in 2005, after 25 October 2005, the subject underwnt a CT scan and ultrasound. The results were not provided.	PVT	PVT	No concurrent medication	Unknown	The subject's medical history and concurrent conditions were not reported. The nurse reported two additional subjects experienced arm pain at the injection site following the administration of FLUARIX. (See A0581510A and A0581512A)		A0581848A	1						1	Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA154AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0249704	12/27/2005	ME				M	12/07/2005	This case was reported by a healthcare professional and described the occurrence of an allergic reaction in an adult male subject who was vaccinated with influenza virus vaccine (Influenza vaccine, manufacturer unspecified) for prophylaxis. On an unspecified date in 2005, the subject received a dose of influenza virus vaccine (manufacturer and dose number unspecified). Information regarding previous immunization with influenza virus vaccine was not provided. At an unspecified time after vaccination with flu vaccine, the subject experienced an allergic reaction which was possible due to thimerosal. At the time of reporting on 10 November 2005, the outcome of the event was unspecified. Follow-up information received on 15 November 2005 indicated that the reporter had no additional details regarding this event. No further follow-up will be conducted.									U				UNK	OTH	OTH		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported.		A0581856A	1						1	Hypersensitivity	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0249705	12/27/2005					F	12/07/2005	This case was reported by a physician and described the occurrence of shortness of breath in a female subject aged between 50 and 59 years old who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The reporter is a radiologist. On 10 November 2005 the subject received 1st dose of Fluarix (lot number not provided). On 10 November 2005 4 hours after vaccination with Fluarix, the subject experienced shortness of breath. The subject was seen on 10 November 2005 by the reporting physician for a chest x-ray. The chest x-ray results were not provided. The outcome of the shortness of breath was not reported.				Y					U	11/10/2005	11/10/2005	0	Chest X-ray 10Nov2005 unknown	OTH	OTH		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported.		A0581976A	1						1	Dyspnoea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0249706	12/27/2005	AZ	47.0	47		M	12/07/2005	This case was reported by a physician and described the occurrence of exanthema in a 47 year old male subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On 16 October 2005 the subject received 1st dose of Fluarix (lot number and site of injection not provided). On 21 October 2005, 5 days after vaccination with Fluarix, the subject experienced exanthem consisting of urticarial papules on the neck, face and upper trunk. The subject was seen at a physician's office and was treated with prednisone. The physician reported that laboratory test results including complete blood count, chemistry profile, serology for valley fever or cocci, and IgE levels were all normal. The outcome of the events was not reported. The physician considered the events to possibly be related to vaccination with Fluarix.				Y					U	10/16/2005	10/21/2005	5	CBC Oct2005 normal;Chemistry NOS Oct2005 normal;IgE Oct2005 normal; October 2005: The reporting physician state that, Serology for Valley Fever and cocci were Normal.	PVT	OTH		UNK	The subject's medical history, concurrent, conditions and concurrent medications were not reported.		A0582002A	1						1	Rash; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0249707	12/27/2005	NC	50.0	50		F	12/07/2005	This case was reported by a nurse and described the occurrence of injection site pain in a 50 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The subject's medical history included hypertension. Concurrent medications included Amlodipine (Norvasc) and Multivitamins (Multivitamin). The subject had no illness at the time of vaccination with Fluarix. On 09 November 2005 at 9:00 a.m., the subject received a dose of Fluarix in the left deltoid (lot AFLUA120AA). A previous dose of influenza virus vaccine (unknown manufacturer) was administered on 04 December 2003. On 09 November 2005, 10 minutes after vaccination with Fluarix, the subject experienced a constant dull pain (4 on a pain scale of 1-10) in the left deltoid and shooting pain (5 on a pain scale of 1-10) on the left side of neck with flexion. The subject took 600 mg ibuprofen (Motrin). On 11 November 2005, at an unspecified time in the morning, the subject awoke with dull pain. The subject took 400 mg Motrin and was pain free by the afternoon of 11 November 2005. The nurse considered the events to be related to vaccination of Fluarix.									N	11/09/2005	11/09/2005	0	UNK	OTH	PVT	Amlodipine;Multivitamin	Hypertension;	The subject had no illness at the time of vaccination with Fluarix.		A0583094A	1						1	Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA120AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249708	12/27/2005	NC	37.0	37		M	12/07/2005	This case was reported by a consumer and described the occurrence of arm tingling in a 37 year old male subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The reporter is the subject. A physician or other health care professional has not verified this report. The subject's medical history included altered sensation of the left side since 28 May 1995. The subject had no concurrent illness at the time of vaccination with Fluarix. Concurrent medications included Naproxen for an unspecified indication. On 15 November 2005 at 2:55 p.m., the subject received 1st dose of Fluarix in the left deltoid (lot AFLUA120AA). Immediately upon receipt of the injection of Fluarix, on 15 November 2005, at 2:55 p.m., the subject experienced left arm tingling and feeling of arm and hand falling asleep. The reporter stated that, the subject received no treatment. The outcome of the events was not reported. Follow up received states - This case was reported by a consumer and described the occcurrence of arm tingling in a 37-year-old male subject who was vaccinated with FLUARIX, GlaxoSmithKline. The initial reporter is the subject. This case was subsequently confirmed by a nurse practitioner. The subject's medical history included arthritis and an altered sensation of the left side since 28 May 1995. The subject had no concurrent illness at the time if vaccination with FLUARIX. Concurrent medications include Naproxen for arthritis. On 15 November 2005 at 2:55 p.m. the subject received 1st dose of FLUARIX in the left deltoid (Lot AFLUA120AA). Immediately upon receipt of the inhection of FLUARIX, on 15 November 2005, at 2:55 P.M., the subject expereinced left arm tingling, feeling of arm and hand falling asleep, and numbness and tingling of the tongue without any oral swelling. The subject was treated with BENADRYL on 15 November 2005. The events resolved on 16 November 2005. The nurse practitioner considered the events to probably be related to vaccination with FLUARIX and also related to his medical history.									Y	11/15/2005	11/15/2005	0	UNK	OTH	PVT	Naproxen	Unknown	Arthritis. The subject's medical history included altered sensation of the left side since 28 May 1995. The subject had no concurrent illness at the time of vaccination with Fluarix.		A0583096A	1						1	Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA120AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249709	12/27/2005	NY	30.0	30		F	12/07/2005	This case was reported by a nurse and described the occurrence of limited range of motion in arm in a 30 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. There were no concurrent medications. On 08 November 2005 the subject received 1st dose of Fluarix in the right arm (lot AFLUA148AA). On 08 November 2005, less than one day after vaccination with Fluarix, the subject experienced limited range of motion in the right arm. At the time of initial reporting, 29 November 2005, the outcome of the event was not provided. The nurse considered the event to possibly be related to vaccination with Fluarix.									U	11/08/2005	11/08/2005	0	UNK	PVT	PVT	NO concurrent medication	UNK	The subject had no pre-existing medical conditions. The subject's concurrent conditions were not reported. The nurse reported that 2 other subjects experienced a limited range of arm motion following immunization with Fluarix. Please see cases A0583912A and A0583913A.		A0583911A	1						1	Joint range of motion decreased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA148AA~1~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249710	12/27/2005	NY	50.0			F	12/07/2005	This case was reported by a nurse and described the occurrence of limited rang of motion in arm in a 50 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. Medical history included tendonitis. There were no concurrent medications. On 09 November 2005 the subject received 1st dose of Fluarix in the left arm (lot number not provided). On 09 November 2005, less than one day after vaccination with Fluarix, the subject experienced limited range of motion and discomfort in the left arm. At the time of initial reporting, 29 November 2005, the outcome of the events was not provided. The nurse considered the events to possible be related to vaccination with Fluarix.									U	11/09/2005	11/09/2005	0	UNK	PVT	PVT	No concurrent medication	UNK	Tendonitis. The subject's concurrent conditions were not reported. The nurse reported that 2 other subjects experienced a limited range of arm motion following immunization with Fluarix. Please see cases A0583911A and A0583913A.		A0583912A	1						1	Discomfort; Joint range of motion decreased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249711	12/27/2005	NY	50.0			F	12/07/2005	This case was reported by a nurse and described the occurrence of limited range of motion in arm in a 50 year old female subject who was vaccinated with influenza virus vaccine for prophylaxis. There were no concurrent medications. On 11/04/05 the subject received 1st dose of Fluarix in the left arm. On 11/04/05, less than one day after vaccination with Fluarix, the subject experienced limited range of motion in the left arm. At the time of initial reporting, 11/29/05, the outcome of the event was not provided. The nurse considered the event to possibly be related to vaccination with Fluarix.									U	11/04/2005	11/04/2005	0		PVT	PVT					A0583913A	1						1	Joint range of motion decreased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249712	12/27/2005	MD				U	12/07/2005	This case was reported by a pharmacist and described the occurrence of injection site soreness in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine for prophylaxis.  On an unspecified date on or after 10/18/05 and on or before 10/28/05 the subject received a dose of Fluarix. The site of injection of the Fluarix was not provided. On an unspecified date in October 2005, less than one month after vaccination with Fluarix, the subject experienced injection site soreness. The injection site soreness resolved on an unspecified date on or before 11/28/05.									Y	10/18/2005	10/28/2005	10		PVT	OTH					A0583939A	1						1	Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249713	12/27/2005	MD				U	12/07/2005	This case was reported by a pharmacist  and described the occurrence of injection site soreness in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine for prophylaxis. On an unspecified date on or after 10/18/05 and on or before 10/28/05 the subject received a dose of Fluarix. The site of injection of the Fluarix was not provided. On an unspecified date in 10/05, less than one month after vaccination with Fluarix, the subject experienced injection site soreness. The subject sought medical attention. The injection site soreness resolved on an unspecified date on or before 11/28/05.				Y					Y	10/18/2005	10/28/2005	10		PVT	OTH					A0583942A	1						1	Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0249714	12/27/2005	MD				U	12/07/2005	This case was reported by a pharmacist  and described the occurrence of injection site soreness in an adult  subject of unspecified gender who was vaccinated with influenza virus vaccine for prophylaxis. On an unspecified date on or after 10/18/05 and on or before 10/28/05 the subject received a dose of Fluarix. The site of injection of the Fluarix was not provided. On an unspecified date in 10/05, less than one month after vaccination with Fluarix, the subject experienced injection site soreness. The injection site soreness resolved on an unspecified date on or before 11/28/05.									Y	10/18/2005	10/28/2005	10		PVT	OTH					A0583943A	1						1	Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249715	12/27/2005	MD				U	12/07/2005	This case was reported by a pharmacist and described the occurrence of injection site soreness in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine for prophylaxis. On an unspecified date on or before 10/18/05 and on or before 10/28/05 the subject received a dose of Fluarix. The site of injection of the Fluarix was not provided. On an unspecified date in 10/05, less than one month after vaccination with Fluarix, the subject experienced injection site soreness. The injection site soreness resolved on an unspecified date on or before 11/28/05.									Y	10/18/2005	10/28/2005	10		PVT	OTH					A0583944A	1						1	Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249716	12/27/2005	MD				U	12/07/2005	This case was reported by a pharmacist and described the occurrence of injection site soreness in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine for prophylaxis. On an unspecified date on or before 10/18/05 and on or before 10/28/05 the subject received a dose of Fluarix. The site of injection of the Fluarix was not provided. On an unspecified date in 10/05, less than one month after vaccination with Fluarix, the subject experienced injection site soreness. The injection site soreness resolved on an unspecified date on or before 11/28/05.									Y	10/18/2005	10/28/2005	10		PVT	OTH					A0583945A	1						1	Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249717	12/27/2005	MH				U	12/07/2005	This case was reported by a pharmacist and described the occurrence of injection site soreness in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date on or after 18 October 2005 and on or before 28 October 2005 the subject received a dose of Fluarix. The site of injection of the Fluarix was not provided. On an unspecified date in October 2005, less than one month after vaccination with Fluarix, the subject experienced injection site soreness. The injection site soreness resolved on an unspecified date on or before 28 November 2005. The nurse reported that 7 other subjects experienced adverse events following the administration of Fluarix. Please see cases A0583939A, A0583942A, A0583943A, A0583944A, A0583945A, A0583947A, and A0583948A									Y	10/01/2005	10/01/2005	0	UNK	OTH	OTH		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported.		A0583946A	1						1	Injection site reaction; Myalgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249718	12/27/2005	MD				U	12/07/2005	This case was reported by a pharmacist and described the occurrence of rash in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date on or after 18 October 2005 and on or before 28 October 2005 the subject received a dose of Fluarix. On an unspecified date in October 2005, less than one month after vaccination with Fluarix, The subject experienced rash. The rash resolved on an unspecified date on or before 28 November 2005. The nurse reported that 7 other subjects experienced adverse events following the administration of Fluarix. Please see cases A0583939A, A0583942A, A0583943A, A0583944A, A0583945A, A0583946A, and A0583948A.									Y	10/01/2005	10/01/2005	0	UNK	PVT	OTH		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported.		A0583947A	1						1	Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249719	12/27/2005	MD				U	12/07/2005	This case was reported by a pharmacist and described the occurrence of rash in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date on or after 18 October 2005 and on or before 28 October 2005 the subject received a dose of Fluarix. On an unspecified date in October 2005, less than one month after vaccination with Fluarix, the subject experienced rash. The rash resolved on an unspecified date on or before 28 November 2005. The nurse reported that 7 other subjects experienced adverse events following the administration of Fluarix. Please see cases A0583939A, A0583942A, A0583943A, A0583944A, A0583945A, A0583946A, and A0583947A.									Y	10/01/2005	10/01/2005	0	UNK	PVT	OTH		UNK	The subject's medical history, concurrent conditions and concurrent medications were not reported.		A0583948A	1						1	Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249726	12/27/2005	TN	63.0	62		M	12/20/2005	Seriousness criteria Other medically significant (OMIC). Initial report received from a consumer, who is a physician, on Dec 13/2005. A 62 year old male patient with no significant past medical history, received a dose of Fluzone SV 2005-2006 USP, lot number unknown, in the left deltoid on Nov 29 2005. The route of administration was not reported. Two to three hours post vaccination, the patient experienced myalgias in his neck and shoulder area, which were followed by pain from his neck to chest with deep inspiration. The symptoms resolved by the following day. The symptoms reoccurred on Dec 6 2005 and resolved by Dec 7 2005. On Dec 10 2005, the patient again developed the same symptoms, but had more severe crushing chest pain. The patient was seen in an ER that day and an electrocardiogram was suggestive of pericarditis. He had EKG changes that suggested acute ischemia and he was transported via helicopter to a heart center. The EKG changes reverted to normal within eight hours. An echocardiogram on Dec 11 2005 was suggestive of pericarditis. A cardiac catheterization on Dec 12 2005 was normal. On Dec 13 2005 he had studies showing open coronary arteries, but apparent pericarditis. No treatment information was provided. At the time of this report the patient was still experiencing mild chest pain and had not recovered from the events.				Y					N	11/29/2005	11/29/2005	0	12/10/2005 EKG suggestive of pericarditis. EKG changes suggested acute Ischema. EKG changes reverted to normal within eight hours. 12/11/2005 Echocardiogram suggestive of pericarditis. 12/12/2005 cardiac catheterization normal.	PVT	UNK	Celexa				200502781	1						1	Chest pain; Myalgia; Myocardial ischaemia; Pain; Pericarditis	FLU3~SANOFI PASTEUR~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249738	12/27/2005	CT	49.0	49		M	12/20/2005	Information has been received from a physician concerning a 49 year old male financial officer with no medical history who on the morning of 11/19/05 was vaccinated in the right arm with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant vaccine therapy given in the left arm included a dose of influenza virus vaccine and a dose of diphtheria toxoid/tetanus toxoid (lot # Td143). There was no illness at the time of vaccination. Subsequently the patient developed a temperature of 104, shaking chills, malaise, and a rash area about the vaccination site. Subsequently, the patient recovered. The physician felt that temperature to 104, shaking chills, malaise and a rash area about the vaccine site were considered to be other important medical events (OMIC) because the patient missed a couple days of work. No further information is expected.									Y	11/19/2005			Body temp 104	PVT	PVT					WAES0512USA00526	1						1	Chills; Injection site rash; Malaise; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~RA~PNEUMO (PNEUMOVAX)~1|TD~UNKNOWN MANUFACTURER~TD143~UNK~~UN~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0249744	12/27/2005	CA	1.59	1	.6	U		Approximately 22 hrs after administration of influenza vaccine, status epileptic generalized, then walk in local facility. Child had brief febrile seizure previously at 10 mos, did not have fever at time of seizure but developed one later in the day,				Y	Y	2			Y	12/07/2005	12/08/2005	1		PVT	PVT	NONE	Mild URI symptoms	Brief febrile seizure at 10 months.			1						1	Epilepsy; Pyrexia	FLU3~SANOFI PASTEUR~U1743GA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0249745	12/27/2005	AL	54.0	54		F	12/12/2005	Numbness to both arms and hands and generalized weakness (unable to raise arm over her head on 12/9/05 and unable to get up from the floor). Referred to MD on 12/12/05 as soon as reported. Medical records state GBS, decreased reflexes, anxiety. msv			Y	Y					Y	12/07/2005	12/09/2005	2	Spinal tap and EMG, DX Guillain Barre syndrome 12/13/2005 Medical records state CSF abnormal, lab test abnormal. msv	PUB	UNK	Prilosec;Wellbutrin; Singular; Actos10mg; Glucophage;Alepucinol 250;Altace		HTN; Insulin Resistant Medical records state renal lithiasis, depression, back pain, allergy, dyspnea; GI disorder, obesity. msv		AL0523	1						1	Anxiety; Asthenia; CSF test abnormal; Guillain-Barre syndrome; Hypoaesthesia; Hypokinesia; Hyporeflexia; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U1881AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0249746	12/27/2005	FL	59.0	59		M	12/16/2005	On 10/27/2005 received Fluzone vaccine for flu prevention at work. On 12/02/2005, employee noticed tearing in left eye excessive, followed by left sided facial paralysis. Other serious important medical events (OMIC). Patient/employee still is having drooping of mouth (L) and some speech slurring. Is still attending speech therapy clases. no real improvement in condition.									N	10/27/2005	12/02/2005	36	Seen in hospital on 12/02/2005 seen by neurologist on 12/05/2005. Pt diagnosed with Bells palsy ? optic nerve involvement with tearing. Information received from the 60 day follow-up states patient/employee still is having drooping of mouth, left and some speech slurring. Is still attending speech therapy classes. No real improvement in condition.	UNK	UNK			Allergy to Flagyl, developed rash after use of drug.			1						1	Dysarthria; Eye disorder; Facial palsy; Facial palsy; Lacrimation increased; Facial palsy; Lacrimation increased; Nervous system disorder	FLU3~SANOFI PASTEUR~41755AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~41755AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0249747	12/27/2005	TN	41.0	40		M	12/20/2005	Reports having body aches early in AM so much so that he was unable to complete his normal work out at the gym. He went home to lie down only to awake later that evening with chills, fever, and some mental confusion (his wife reported that he was holding his hand out as if holding a cup but there was no cup there. She called and was advised to give Motrin q 8 hours alternating with Tylenol q 4-6 hours. The confusion and somnolence increased and she again called, spoke with MD who advised to take to ER. He was evaluated at ER, Rx'd with IV's for dehydration and released. Early the next morning, he became increasingly confused and somnolent and developed fecal incontinence. She again called and was advised by he MD to call 911 and return to the ER. He was evaluated there CT scan, MRI and a spinal tap was accomplished that was positive for elevated protein and 20 cells. A consult was obtained and it was decided that VIG was not indicated and the member was transferred to another hospital's ICU. 1/4/06 D/C summary indicates final diagnosis was post-vaccine encephalitis.  1/4/06 Review of medical indicates additional symptoms/conditions include altered mental status, seizure followed by apnea, tachycardia  due to anxiety/agitation, and ataxia.				Y	Y	8				11/22/2005	12/01/2005	9	LP positive for elevated protein and 20 cells, MRI non focal HSV PCR and VDR negative (other tests pending). USAMRIID consulted and concurrence that VIG was not indicated.	MIL	MIL	Multi vitamin		Allergic Rhinitis			1						1	Agitation; Anxiety; CSF test abnormal; Chills; Confusional state; Convulsion; Coordination abnormal; Dehydration; Encephalitis; Faecal incontinence; Hypokinesia; Laboratory test abnormal; Pain; Pyrexia; Somnolence; Tachycardia	FLUN3~MEDIMMUNE VACCINES, INC.~50039~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~SMITHKLINE BEECHAM~AHAVB087AA~2~IM~UN~HEP A (HAVRIX)~1|SMALL~PFIZER\WYETH~4020072~2~~UN~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~X0300~2~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Hospitalisation	Influenza
0249749	12/27/2005	VA	61.0	61		F	12/16/2005	Approx at 10:55 c/o sob and feelings of something in her throat. A/0X3 no immediate distress of any observed. Benadryl 25 mg IV given by EMS. Pt recovered d/c to home per coworker on 12/16/05.				Y					U	12/16/2005	12/16/2005	0		MIL	MIL	Insulin	SOB/ short of breath				1						1	Dyspnoea; Throat tightness	FLU3~SANOFI PASTEUR~U1778AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249752	12/27/2005	CA	32.0	31		M	12/08/2005	Symptoms - diffuse rash on scalp, neck, upper chest and behind ears. Signs - macular, papular, pretubal rash sparing hands, lower extr. and lower abdomen; pustular lesions were only on the neck, no ulcerations/blisters/scale/oozing. Not oily or flaky in appearnce. Non-pruritic. Time - 10 days past small pox vaccianation  Treatment - cloberasol 0.054 solution to scalp; triamcinalone 0.1% cream to other regions.									Y	11/09/2005	11/19/2005	10		MIL	MIL	synthroid		Hogdkins lymphoma, hypothyroidism due to radiation treatment 200+			1						1	Exfoliative rash; Rash maculo-papular; Skin ulcer	FLUN3~MEDIMMUNE VACCINES, INC.~500391P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~PFIZER\WYETH~40P0072~1~~LA~SMALLPOX (DRYVAX)~1|TYP~BERNA BIOTECH, LTD.~Z00422~2~IM~RA~TYPHOID LIVE ORAL TY21A (VIVOTIF)~1	USA		Influenza
0249753	12/27/2005	NY	40.0	40		F	12/15/2005	0950 pt sitting flushed face, slight wheezing bilaterally anterior/posterior like. B/P 178/98 p 120 R- 28 Treated with albuterol duffs- self admin. wheezing decreased. 0958 BP 180/110 AP - 64 R - 26. Hives left shoulder area noticed at 1000. Epin 1:1000.3 given right arm SQ, wheezes increased bilat. Medical ambulance called 1/20: Spoke with Dr. at hospital ED 11:20. Patient to be D/C'd from ED and doing well.				Y					Y	12/15/2005	12/15/2005	0		UNK	UNK			Asthma, sevel food allergies(not eggs)			1						1	Flushing; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U1863AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249754	12/27/2005	GA	0.75	0	.8	F	12/20/2005	Pt given flu shot and returned about 15 min later covered with hives. No respiratory distress. Gave nebulizer treated with Xopenex 0.63mg, 4mg Decadron IM, 0.1 ml of Epinephrine 1:1000 mg hives resolved after about 30 min.				Y					Y	12/20/2005	12/20/2005	0		PVT	PUB	Cefzil 125/5	Otitis media, cough	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1788DA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249755	12/27/2005	VA	6.0	5		M	10/22/2005	Sore throat, congestion, cough, fever, severe bilateral otitis media with perforation.									Y	10/17/2005	10/17/2005	0	NONE	PVT	PVT	NONE	NONE	Benign rolander epilepsy			1						1	Cough; Nasal congestion; Otitis media; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500389P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0249756	12/27/2005	ME	43.0	42		M	12/07/2005	Mild swelling, redness, tenderness at Td site. Flu like symptoms: body aches, fatigue, dizziness) Most symptoms lasted 4 days. Soreness in left arm lasted one week.									Y	12/04/2005	12/04/2005	0		MIL	MIL			shell fish allergy	flu like symptoms~Vaccine not specified (no brand name)~~23.00~In Patient		1						1	Dizziness; Fatigue; Influenza like illness; Injection site erythema; Injection site oedema; Pain; Tenderness	FLU3~SANOFI PASTEUR~U1911AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~AVENTIS PASTEUR~U1215DA~3~IM~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0249757	12/27/2005	MA	56.0	56		M	12/19/2005	16-18 hour after receipt- deathly ill - cold sweats, stomach convulsions ie vomiting, eyes would not stop rotating. eyes couldn't focus, blurred vision. Eyes still blurry, stomach still upset.									N	12/14/2005	12/15/2005	1		PUB	PUB						1						1	Abdominal discomfort; Eye disorder; Hyperhidrosis; Malaise; Vision blurred; Vomiting	FLU3~SANOFI PASTEUR~U1831AB~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249758	12/27/2005	AZ	5.0	4		F	12/16/2005	12/01/05 Phone call: Mom states right arm swollen twice as big as left arm. Advised appt. 12/05/05 office visit: right arm redness, swelling, mild cellulitis likely vaccine related.				Y					Y	11/29/2005	11/30/2005	1		UNK	PUB	NONE	NONE	NONE			1						1	Cellulitis; Erythema; Oedema	DTAP~SMITHKLINE BEECHAM~628B9~5~IM~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1825CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~025AA~2~IM~LA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~Y02982~4~SC~~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0579R~2~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0249759	12/27/2005	ID	26.0	26		F	11/23/2005	Immediately after receiving flumist, pt felt nausea and vomited once. She subsequently felt progressively better.				Y					Y	11/23/2005	11/23/2005	0		MIL	MIL						1						1	Nausea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500390P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0249760	12/27/2005	CA	51.0	51		M	12/19/2005	Awoke 11:00 pm with high fever and body aches. Did not feel good enough to take temp until 5:00 am. Temp 100.8. At 6:00 am temp down to 100.0. Had low grade fever and minor body aches until around 12/18/05 12:00 noon. Treatment : 3 doses of 1000 mg tylenol 12/17/05.									Y	12/16/2005	12/16/2005	0		OTH	PVT						1						1	Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1905AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249761	12/27/2005	MO	67.0	67		F	12/18/2005	Break out in rash covering body from face to knees. Comes back approximately every 6 days. Treatment- 2 benedryl tablets									N	11/09/2005	11/09/2005	0		OTH	OTH			Hypertension, Meniere's disease			1						1	Rash	FLU3~SANOFI PASTEUR~U1825EA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249762	12/27/2005	PA	8.0	8		F	12/16/2005	Influenza vaccine administered. Patient got up and walked across room and fainted; several minutes later. She woke up 2-3 seconds later and became alert.				Y					Y	12/14/2005	12/14/2005	0		PVT	PVT						1						1	Syncope	FLU3~SANOFI PASTEUR~U1910AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249763	12/27/2005	AL	3.0	2	.5	M	10/06/2005	Child started vomiting 1 1/2 hr after shot and continued to vomit every 15 minutes from 2:30 - 6:30 pm and gave emetrol and vomiting stopped.									Y	10/05/2005	10/05/2005	0		PVT	OTH						1						1	Vomiting	FLU3~SANOFI PASTEUR~U1743MA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249764	12/27/2005	AK	25.0	24		F	11/03/2005	States Flu Shot given in right deltoid. Right shoulder sore cannot raise above shoulder level without pain - injection given 3 weeks prior and symptoms have been present since injection (next am).									N	10/12/2005	10/13/2005	1	NONE	PUB	PUB	NONE	NONE	NONE		AK200589	1						1	Hypokinesia; Myalgia; Pain	FLU3~SANOFI PASTEUR~U1754AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~UNKNOWN MANUFACTURER~122~2~~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0249765	12/27/2005	AK	73.0	72		F	11/14/2005	Client call c/o redness, pain, swelling on her left arm. The redness start from the site extended under arm to above elbow about hand sized after 24 to 48 hours after administration.									Y	11/10/2005	11/11/2005	1	NONE	PUB	UNK		NONE	NONE		AK200588	1						1	Erythema; Pain; Swelling	FLU3~SANOFI PASTEUR~U1754AA~7+~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0346R~3~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249766	12/27/2005	AK	1.19	1	.2	M	12/14/2005	14 mo male had MMR and varicella immunization 11/21/05. 11/29/05 had fever 101.9 degrees and minimal seizure . W/U and exams at the time was not revealing a source of infection. ? ear infection, Rocephin was given IM. Parents have continued to monitor temperature every time the diaper is changed. In the evening pt has 100.4-101.4 temp. No other symptoms. No crying, appetite good, normal BM, playing normally, gaining wt. No vomiting, diarrhea, pulling ears, or cough. Fever non specific. Rash could represent modified measles infection from the immunization. No evidence of encephalitis at present. CDC description of fever from measles is short deviation (2-3 day), varicella has also been described as producing a fever. Pt not toxic and the rash may be from any number of wild viruses in the community. Teething may give febrile reaction. Parents continue to be concerned so will give Zithromax for possible occult infection. Without more than occasional  fever would not advocate spinal fluid analysis, blood cult or repeat blood w/u.									Y	11/21/2005	11/29/2005	8		PUB	OTH	NONE	NONE	NONE		AK2005101	1						1	Convulsion; Pyrexia	FLU3~SANOFI PASTEUR~U17431A~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1152N~3~IM~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0294R~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0197P~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0249767	12/27/2005	MN	10.0	9		M	12/22/2005	Hives on arms, face, upper back occurred about 24 hr after influenza vaccine was given. No respiratory symptoms.									U	12/21/2005	12/22/2005	1		PVT	UNK	Flovent;Albuterol	Mild cold symptoms	Mild Asthma			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1802BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249768	12/27/2005	NM	51.0	50		F	12/13/2005	Patient received flu vaccine 11/16/05. Later that evening became dizzy, felt fluttering sensation in right breast and fainted. Also felt itchy. S/S continued next day, though decreased and with no fainting. Urged pt to go to Urgent Care.				Y					Y	11/16/2005	11/16/2005	0		OTH	OTH	Lexapro;Allegra					1						1	Dizziness postural; Pruritus; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0249769	12/27/2005	WI	55.0	55		M	12/19/2005	Immunized afternoon of 12/10/05. Afternoon 12/17/05 developed arm pain, body aches worsened 12/18/05 - developed redness/warmth. Circumferential diagonal  around 2/3 of upper arm - pm of 12/19 started to have some improvement. Recommended Aleve 2 BID and heat.									N	12/16/2005	12/17/2005	1		PVT	PVT	Monopril;Lipitor(started after vaccine); Triamterene;Coreg	NONE	Cardiomyopathy;CHF 10/04 significantly improved;Hypercholesterolemia;HTN			1						1	Erythema; Feeling hot; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~63193~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C2151AC~UNK~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0249770	12/27/2005	PA	62.0	62		F		11/11/05 Within the following week I could not raise my arm in a certain direction due to the pain that I felt in my muscle. By 12/8 the pain was now in my armpit, down the inside of the arm and slightly across top part of left breast. Went for EKG OK. Dr Rx cephalexin helped to rid the lymph glands of infection. But the muscle still has not recovered. Improved but still very sore.				Y					N	11/11/2005	11/11/2005	0		PUB	UNK	Lipitor;Levoxyl	NONE				1						1	Hypokinesia; Myalgia; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62014~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0249771	12/27/2005	WI	50.0	49		F	12/20/2005	10 cm elevated rash at injection site. 3 cm purple area in center.										12/14/2005	12/16/2005	2		UNK	PVT						1						1	Injection site reaction; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62217~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0249772	12/27/2005	WI	66.0	65		M	12/17/2005	Erythemic wheal at injection site 2cm diameter.										12/13/2005	12/17/2005	4		UNK	PVT						1						1	Injection site erythema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62217~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0249773	12/27/2005	GA	42.0	42		M	12/13/2005	4 days after injection, soreness with tingling in the thumb (left side)				Y					U	12/03/2005	12/07/2005	4		MIL	MIL	Ibuprofen, hydrocodon	Dental surgery on 11/30/05	Dental surgery on 11/30/05			1						1	Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U1911AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249774	12/27/2005	CO				F	12/05/2005	Warm to the touch, egg size lump on arm.									U	10/21/2005	10/21/2005	0		UNK	UNK						1						1	Injection site mass; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA129AB~UNK~IM~AR~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249775	12/27/2005	CO				F	12/15/2005	Got flu shot appox 08:45 am 5-10 min later left arm was throbbing from shoulder to tips of fingers. About 1 hour after flu shot she began to feel ill. Headache started- took advil to try to avoid. Stomach was upset - Ran fever and got the chills. About 1 hour later, room began to spin. Thought she was going to pass out. Went home where she did become ill and then fell asleep. Slept until evening. Felt better Saturday.									Y	10/21/2005	10/21/2005	0		UNK	UNK						1						1	Headache; Malaise; Pain; Stomach discomfort; Vertigo	FLU3~GLAXOSMITHKLINE BIOLOGICALS~A129A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0249810	12/27/2005	PA	49.0	49		F	12/27/2005	Client first recv'd the Flu Vaccine in the left arm, and then approximately 1 minute later received Pnuemococcal vaccine in the right arm. About 2 minutes later, client c/o not feeling good, with queezy stomach and nausea. Client became very flushed in the face and neck area. Both sites of injection appeared to be minimally swollen and slightly red. Client denied any shortness of breath. HR was 80 -88.  BP was 140/80. Epinepherine was not administerd, as client stated that she felt better after a few minutes.  BP returned to 110/70, and HR 80. Flushing subsided significantly, and nausea subsided. Clients allergist was contacted. She advised pt to take Allevert when she got home. Per, post-event phone conversation with Client, Client stated she did take Benedryl when she got home, and was feeling fine.									Y	12/13/2005	12/13/2005	0	none	UNK	UNK	Alavert, prn.	none	Seasonal and environmental allergies. Client is in the process of allergy desensitization.			1						1	Blood pressure increased; Flushing; Injection site erythema; Injection site swelling; Malaise; Nausea	FLU3~SANOFI PASTEUR~U1904AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0791P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249811	12/27/2005	IA	60.0	59		F	12/27/2005	Main symptom was dizziness. Started doctoring on November 3, 2005/shot administered on November 1, 2005 and I woke up on November 2, 2005 with the symptoms. I was feeling great before the vaccine. The symptoms developed into ear infection, rhinitis, sinustitis (I already have chronic sinusitis) but symptoms worsened. I am still being treated by ENT doctors for ear trouble. I had to have sinus x rays, cat scan (facial) and medications to fight this condition and am still doctoring for flu like symptoms which are ear aches, body aches, neck pain and bad headaches.  This has resulted in a lot of medical bills so far to fight this problem. I have already had 6 doctor visits and the two x rays. Doctor will not rule that this illness is a reaction to the flu shot, but I think that it is more than a coincidence that the morning after the vaccine, 20 hours I would wake up sick and still have to be treated for flu type symptoms.  This has caused hardship for paying bills and trying to work while sick.  Thanks.				Y					N	11/01/2005	11/02/2005	1	cat scan(facial) showed ear trouble sinus x ray showed no inflammation the blood tests showed everything o.k. with the blood.	UNK	UNK	Lipitor, Atenolol, Zyrtec, Singulair	Only sinus trouble and the onset of rhinitis(perhaps)	Environmental allergies, hypertension, high cholesterol, obesity.			1						1	Condition aggravated; Dizziness; Ear pain; Headache; Influenza like illness; Neck pain; Otitis media; Pain; Rhinitis; Sinusitis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA147AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0249812	12/27/2005	FL	36.0	36		F	12/27/2005	Severe atrophy of upper arm muscle, pain to touch.				Y					U	10/14/2005	10/17/2005	3		UNK	UNK		None	None			1						1	Injection site atrophy; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0249813	12/27/2005	NM	54.0	54		F	12/27/2005	Recv'd Short at 3:30pm at work; within 2 hrs, started feeling feverish and had cramping in the lower intestines.  While returning from the restroom, I passed out in the hallway, hit my head, refused medical treatment, was taken home by supervisor, who called every half hour to make sure I was OK.  Bad headache resulted from fainting due to hitting the back of my head on the concrete floor.  Headache lasted approximately 4 (four) days, accompanied by nausea.									Y	12/15/2005	12/15/2005	0		UNK	UNK		none	Allergies to sulfa, Darvacet, Percacet, and Codeine.			1						1	Abdominal pain; Headache; Injury; Loss of consciousness; Nausea; Pyrexia; Syncope	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0249817	12/27/2005	MI	0.53	0	.5	F	12/22/2005	Called pt mom told mom what mistake was done. Ask mom how baby was doing. Mom states baby is fine, no complaints.									Y	12/20/2005	12/20/2005	0	NONE	OTH	PUB	NONE	NONE				1						1	Medication error	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A017AA~2~~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1788HA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0516P~2~~RL~HIB (PEDVAXHIB)~1|MNQ~SANOFI PASTEUR~U1722AA~UNK~~RL~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0248254	12/28/2005	UT	71.0	71		F	12/23/2005	Erythematous lump resolving with diphenhydramine however patient went to private MD who began dicloxacillin.									Y	11/17/2005	11/19/2005	2		OTH	UNK						1						2	Contusion; Hypersensitivity; Injection site erythema; Injection site reaction; Injection site swelling; Pruritus; Tenderness; Erythema	UNK~UNKNOWN MANUFACTURER~~UNK~~~VACCINE NOT SPECIFIED (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1808AB~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0249821	12/28/2005	IL	1.61	1	.6	F	12/28/2005	None Stated Autopsy Report received 3/16/06 revealed COD as bronchopneumonia.	Y	12/12/2005							N	12/06/2005	12/12/2005	6		PVT	PVT	NONE					1						1	Pneumonia	FLU3~SANOFI PASTEUR~U1788FA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0249823	12/28/2005	PA	13.0	13		M	12/22/2005	Initial report received on Dec 20 2005 from the patients parent. A 13 year old male patient with a history of Angelman's syndrome diagnosed at age two and seizures received an injection of Fluzone SV 2005-2006, lot number unknown, route and site of administration unknown, on Nov 16 2005. Illness at the time of vaccination was none. Per the reporter, the patient seizure activity had been controlled with medications, and his last seizure had occurred in March 2005. On Nov 22 2005, seizure activity began and gradually worsened. He experienced three seizures on that day. The parent administered Diastat, and the seizure activity stopped. On Nov 24 2005, the patient had two seizures. An ear infection was suspected, and the patient was prescribed Amoxicillin. Examination by the patients physician on Nov 26 2005, following two additional seizures, revealed no ear infections. On Dec 2 2005, the patient was examined in an ER after having continued seizure activity. he was administered Dilantin and admitted to the hospital. Total number of seizures on that day were 18. Additional medications used in treatment were Depakote, Topamax, Klonopin and Zarontin. Per the reporter, a videography test determined that the patient had continuous seizures from Dec 6 2005 to Dec 7 2005. At the time of this report, the patient remained hospitalized and had not recovered.					Y				N	11/16/2005	11/22/2005	6		UNK	UNK			The patient has a history of Angelman's syndrome and seizures.		200502811	1						1	Abnormal behaviour; Mental retardation severity unspecified; Microcephaly	FLU3~SANOFI PASTEUR~~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0249825	12/28/2005	MI	1.0	1	.0	F	12/22/2005	Patient had well check 12/15/2005, had vaccines, went for screening CBC within 2-3 hours of the visit. Patient has continued to have low platelet counts- most recently 120,000 on 4-4-06.					Y	1			U	12/15/2005	12/15/2005	0	Platelet count 43,000 on 12/15/2005, 16,000 on 12/16/2005	OTH	PUB		Loose stool 3-4 times per day.				1						1	Platelet count decreased; Unevaluable event	FLU3~SANOFI PASTEUR~U1823AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0234R~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0418R~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0249827	12/28/2005	KY	67.0	66		F	12/20/2005	The person giving me the flu shot gave it to me in the wrong area; into tendon and the injection was extremely painful. I have had flu shot before; never, never was it so painful. I can barely raise my right arm. It is difficult to get dressed and extremely painful. My doctor has suggested I go to physical therapy. I am in pain all of the time.Information from Medical records states disc disease, arthritis, tendonitis. msv				Y				Y	N	11/18/2005	11/18/2005	0	Information from Medical records states lab tests abnormal. msv	OTH	OTH	NONE		Medical records state Hx of arthritis. msv			1						1	Arthritis; Bone disorder; Hypokinesia; Laboratory test abnormal; Medication error; Pain; Tendonitis	FLUX~UNKNOWN MANUFACTURER~62445~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0249828	12/28/2005	MI	79.0	79		F	12/20/2005	RX Guillain Barre syndrome. Symptom bilateral leg weakness, numbness and tingling in extremities it began on 12/08/2005 is currently being evaluated for rehab. Was unable to ambulate. GBS confirmed in medical record 02/04/06. msv Medical records state hematuria, urinary tract infection, renal failure. msv Patient can walk, but she still has numbness in her arms and legs				Y	Y	11			Y	11/29/2005	12/11/2005	12	Spinal fluid, 0 WBC, Gluc 15, protein 84, MRI ruled out radiculopathy and brain abnormalities, CT scan no disc herniation or spinal stenosis.  Medical records state leukocytosis, hyponatremia. msv	PUB	PVT	Novolin insulin;Lanoxin;Cardizem;Theo-Dur		Diabetes A fib, COPD, Chronic renal failure.  Medical records state Hx of pain, adrenal adoma, atrial fib, osteopenia, heart failure, hypertension; also granuloma, pancreatitis. msv			1						1	Asthenia; CSF test abnormal; Guillain-Barre syndrome; Haematuria; Hypoaesthesia; Hyponatraemia; Leukocytosis; Paraesthesia; Renal failure; Urinary tract infection	FLU3~SANOFI PASTEUR~U1764AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0249829	12/28/2005	NC	23.0	22		F	12/05/2005	Intrauterine fetal demise at 39 weeks and 4 days (? cord accident)									Y	10/25/2005	11/15/2005	21		PUB	PVT	prenatal vitamins				NC05112	1						1	Intra-uterine death	FLU3~SANOFI PASTEUR~U1747AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249830	12/28/2005	NC	18.0	17		F	12/01/2005	Pt reports went to ER and treated for hives- was given benadryl 11/05/05				Y					Y	11/04/2005	11/05/2005	1		PUB	PVT	prenatal vitamins				NC05113	1						1	Urticaria	FLU3~SANOFI PASTEUR~U1815AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249831	12/28/2005	NC	32.0	32		F	12/05/2005	Pt with intrauterine fetal demise at 24 weeks and 3 days. 12/02/05									Y	11/04/2005	12/02/2005	28		PUB	PVT	prenatal vitamins, iron				NC05114	1						1	Nonspecific reaction	FLU3~SANOFI PASTEUR~U1815AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249832	12/28/2005	NC	21.0	20		F	12/01/2005	Pt delivered stillborn infant 11/25/05 32 weeks and 5 days gestation.									Y	10/26/2005	11/25/2005	30		PUB	PVT	prenatal vitamins, iron				NC05115	1						1	Stillbirth; Unintended pregnancy	FLU3~SANOFI PASTEUR~U1747AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249833	12/28/2005	NC	18.0	18		F	12/01/2005	Pt had intrauterine fetal demise at 27 weeks and 3 days gestation. (11/21/05).									Y	10/26/2005	11/16/2005	21		PUB	PVT	prenatal vitamins				NC05116	1						1	Nonspecific reaction	FLU3~SANOFI PASTEUR~U1836AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249834	12/28/2005	NC	62.0	62		F	12/01/2005	On 11/30, 15 minutes after injection, felt like tongue went to sleep and ants were crawling on tongue. At same time as these sensations, also felt very sleepy. No difficulties breathing or swallowing, no chest pain, no rash or pruritis. At 0400 12/01/05, right side of face felt heavy and swollen. Also with headache over right eye. At time of clinic visit 12/01/05 at 1140, face felt less heavy/swollen and headache less severe. Complaining of dizziness. Right arm BP 162/116. Referred to ED at local hospital and to be taken by daughter, son, husband who accompanied her to clinic this am. Denied problems at injection site. Slightly warm to touch and slightly tender- no site edema, erythema or bruising.				Y					Y	11/30/2005	11/30/2005	0	EKG, chest CT normal	PUB	PUB	acetaminaphen		S/P breast surgery in 1986 for malignancy		NC05117	1						1	Dizziness; Face oedema; Headache; Hypertension; Skin warm; Somnolence; Tenderness; Tongue disorder	FLU3~SANOFI PASTEUR~U1854AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249835	12/28/2005	NC	20.0	19		F	12/16/2005	12/09/05 IUFD EDC 12/09/05 delivered 12/09/05 at 1629 SVD male 5 lb 14 oz without apgars 0/0									Y	11/16/2005	12/09/2005	23		PUB	PUB	prenatl vitamins daily				NC05120	1						1	Nonspecific reaction	FLU3~SANOFI PASTEUR~U1815AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249836	12/28/2005	PA	66.0	66		F	01/09/2006	Within one week hive,congestion,muscle aches, joint pain.										11/02/2005	11/12/2005	10	NONE	PUB	OTH	Insulin Diabetic Type I	NONE	Sensitivity to mold			1						1	Arthralgia; Myalgia; Nasal congestion; Urticaria	FLU3~SANOFI PASTEUR~U1863AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249837	12/28/2005	TX	37.0	37		M	12/21/2005	Red rash. Dr orders Benadryl 100mg times 1 dose PO;Benadryl 100mg PO at bedtime times 5 days.									Y	12/19/2005	12/20/2005	1		OTH	OTH	Enalapril;NPH Insulin;Glyburide		Vancomycin;PCN;Cipro			1						1	Erythema; Rash	FLU3~SANOFI PASTEUR~U1917AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249838	12/28/2005	CA	1.19	1	.2	M	12/21/2005	Patient had appointment with Dr on 12/19/2005 at 11:22 am with hx of rash on body for the last 3-4 days. He got VZV on 11/28/05. No fever.										11/28/2005	12/15/2005	17	C. pox secondary to VZV Vax	PVT	PVT						1						1	Rash	FLU3~SANOFI PASTEUR~U1787EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0382R~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0625R~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0249839	12/28/2005	WA	49.0	49		F	12/22/2005	1 day after injection pt had rash, warm extremities, nausea, generalized itching.									Y	12/21/2005	12/21/2005	0		OTH	PVT		NONE	HTN;Hyperlipidemia			1						1	Feeling hot; Nausea; Pruritus; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62936~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0249840	12/28/2005	OH	8.0	8		F	12/22/2005	Papules and early vesicles suggestion of post vaccine chicken pox. Distributed on scalp, trunk and extremities.									Y	12/01/2005	12/22/2005	21		PVT	PVT	NONE	Cough;Bronchitis				1						1	Acne; Blister	FLU3~SANOFI PASTEUR~U1854AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~062912~1~IM~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0249841	12/28/2005	CO	51.0	50		F	12/12/2005	Acute onset of pain and swelling 48 hours in right knee s/p transplantation 10/05, spontaneous resolution at 72 hours.									Y	12/06/2005	12/07/2005	1	NONE	PUB	PUB	Many	NONE	Many			1						1	Pain; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0249842	12/28/2005	GA	75.0	75		F	10/31/2005	Pt called to c/o fever, chills, pain, redness, and swollen at site of injection (Lt Arm). Pt states pain 20 mins after receiving vaccines. Pt went to Dr and was given pain medication and prednisone. Meds. also includes Darvocet, Keflex.				Y					N	10/25/2005	10/25/2005	0	NONE	PUB	PUB	Vitamin;Calcium;B/P Meds;Thyroid Meds	NONE	Hx of Breast Cancer;Hypertension;Thyroid Disorder			1						1	Chills; Injection site erythema; Injection site oedema; Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~U1836AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0456P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0249843	12/28/2005	PA	1.8	1	.8	F	12/23/2005	Pt developed a temp to about  105 degrees F approximately 24 hrs after vaccines and then had a seizure for approximately 15 seconds. Medical records state vomiting. msv				Y					Y	12/14/2005	12/15/2005	1	RSV positive Medical records state leukocytosis. msv	PVT	PUB		URI	G-6-PO deficiency carrier Medical records state congemnital anomaly. msv			1						1	Convulsion; Leukocytosis; Pyrexia; Vomiting	DTAP~SANOFI PASTEUR~C2325AA~4~IM~UN~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1743IA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249844	12/28/2005	RI	0.55	0	.6	F	12/07/2005	Rash all over body - no fever									Y	12/05/2005	12/06/2005	1		PVT	PVT		NONE	NONE			1						1	Rash	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A013AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1844HA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A25962A~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0249845	12/28/2005	MA	70.0	70		F	12/23/2005	Received influenza and pneumovax at approx. 3 pm 12/21/05 - Developed muscle aches and low grade fever 100-101 po, and H/A at approx 6 pm on 12/21/05. Still has sx's - taking O.T.C. Motrin/Aspirin.										12/21/2005	12/21/2005	0		PUB	OTH	NONE	NONE	NONE			1						1	Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1831AB~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577R~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0249847	12/28/2005	MA	70.0	70		F	12/19/2005	12/13/05 very tired, coughing, congestion, fever 102 degrees. Biaxin 10 days.									Y	12/08/2005	12/13/2005	5		PUB	PUB	Fosamax	NONE	NONE			1						1	Cough; Fatigue; Nasal congestion; Pyrexia	FLU3~SANOFI PASTEUR~U1831AB~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249848	12/28/2005	MA	21.0	20		F	12/20/2005	Rash at injection site for influenza vaccine. Pt prescribed cephalexin 500 mg q.i.d. by another physician.				Y					Y	12/07/2005	12/19/2005	12	NONE	PVT	UNK	Zoloft 23 mg qd;Oral contraceptions	NONE	NONE			1						1	Injection site rash	FLU3~SANOFI PASTEUR~U1872AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~07832~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0249849	12/28/2005	CA	4.0	4		F	12/21/2005	Redness, swelling, and warmth to injection site on right deltoid in a 2' circumference around site.									Y	11/30/2005	12/01/2005	1	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Injection site erythema; Injection site swelling; Injection site warmth	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B010AA~1~~RA~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1754AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0232R~2~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0249852	12/28/2005	VA	44.0	44		F	12/28/2005	Influenza vaccination administered at 0650am 12/15/05 in left deltoid. 12/16 muscle aches, lower back cramping, lethargic, very tired, took Motrin for symptoms. 12/17 on awakening in early morning weak, very fatigued, nauseated-dry heaves, shaking uncontrollably--called EMS and was transported and treated in ER at hospital. Fever 103.7 was treated w/ IV fluids and d/c home. Continued with headache and nausea 12/18 & 12/19. Slowly began to feel better. Reported to me 12/20.				Y					Y	12/15/2005	12/16/2005	1		MIL	PVT		none	none			1						1	Asthenia; Fatigue; Headache; Lethargy; Muscle spasms; Myalgia; Nausea; Pyrexia; Retching; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61503~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0249853	12/28/2005	PA	67.0	67		F	12/28/2005	Severe left arm pain.				Y					N	11/28/2005	11/28/2005	0	Nerve conduction studies reported as idiopathic brachial neuritis.	UNK	UNK	Amitriptyline, HCTZ, Actonel, Metformin, Synthroid, ASA , Mg. Oxide, K-dur	none	Type 2 DM, Osteoporosis, Hypothyroidism			1						1	Pain; Radiculitis brachial	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62018~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0249854	12/28/2005	NM	10.0	10		F	12/28/2005	Patient had bilateral calf muscle aches, watery eyes, low grade fever and general malaise 12- 24 hours after her first flu shot. The symptoms were severe enough that she came to the clinic crying. Influenza A and B swabs were negative and exclude a concommitant influenza infection. Treatment: oral ibuprofen with good relief at the clinic. Informational sheets regarding adverse effects of flu shots given to mother.				Y					U	12/27/2005	12/28/2005	1	Influenza A and B antigen are negative	UNK	UNK		None	None			1						1	Lacrimation increased; Malaise; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1787AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249855	12/28/2005	OH	82.0	81		F	12/28/2005	Received Flu vaccine on 12/21/2005.  Rash started 12/23/05.  Complained of itching and rash on upper torso.  States looks like measles.  No fever or other symptoms.  Has Fractured arm (5 weeks ago) and is under care of a doctor.  States no pain meds									U	12/21/2005	12/23/2005	2		UNK	UNK	Baby ASA QD, Coreg	None	Broken Arm: 5 weeks ago.			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~u1872AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249856	12/28/2005	OH	84.0	83		F	12/28/2005	Bruise and pain on Left arm within 1-2 days after vaccination.  Used heat/ice.  On Mobic for spinal stenosis and getting injections for spinal stenosis.									N	11/02/2005	11/03/2005	1		UNK	UNK	Mobic		Spinal Stenosis    On 12-28-2005 talked with patient on telephone.  Pt. states saw doctor today.  States he feels that she has rotator cuff problems in left shoulder.			1						1	Contusion; Pain	FLU3~SANOFI PASTEUR~U1838AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249858	12/28/2005	TX	69.0	69		M	12/27/2005	Developed neck myalgia, as well as in shoulders and arms; progressed to facial weakness, dysarthria and extreme weakness and gait ataxia (over 3-4 days). Information received from the 60 day follow-up states re-hospitalized 3-2-06 to 3-4-06 with recurrent facial and lower extremity weakness.					Y	13			Y	12/08/2005	12/11/2005	3	Spinal tap - CSF = increased glucose and increased total protein; Multiple other labs (WBC normal).	PVT	PVT	Ultram; Flomax; Colare; Ambien; Tramadol	Bronchitis	Allergy - codeine			1						1	Blood glucose increased; CSF test abnormal; Coordination abnormal; Dysarthria; Facial paresis; Lumbar puncture; Muscular weakness; Myalgia; White blood cell count	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0249861	12/28/2005	ME	59.0	59		F	12/20/2005	Left deltoid paint no redness, warmth, swelling. No fever, sweats/chills. Pain seems to be slowly increasing.									Y	12/06/2005	12/06/2005	0	NONE	PUB	PUB		NONE	Ampicillin Allergy			1						1	Pain	FLU3~SANOFI PASTEUR~U1823AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249881	12/28/2005	GA	0.53	0	.5	M	12/12/2005	Within 10 Minutes of vaccines developed severe hives diffusely but no wheezing.				Y					Y	12/12/2005	12/12/2005	0	Pulse oximetry 97-99%	PVT	PVT	NONE	NONE	NONE			1						1	Urticaria	DTAP~SANOFI PASTEUR~C2325AA~3~~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U17430A~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE800AA~3~~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B08636H~3~~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0249890	12/28/2005	GA	1.02	1	.0	M	12/21/2005	Information has been received from a licensed practical nurse concerning a 12 month old male with no allergies or medical history who on 07-Nov-2005 was vaccinated in the left thigh with a dose of PROQUAD (lot # 651812/0769R). Concomitant vaccinations on the same day included a dose in the right thigh of PEDVAXHIB (OMPC) (lot # 651665/0482R) and a dose in the arm of influenza virus vaccine (unspecified). The patient's mother called the physician's office on 09-Nov-2005 to report that the child had a fever of 100.4 on 08-Nov-2005. She gave him MOTRIN. The fever went to 102.8 on 09-Nov-2005. The child was seen by the physician on 09-Nov-2005 and his fever was 103. The child was kept in the office and TYLENOL and MOTRIN were alternated to get his temperature down. The last temperature was 101.3. Laboratory tests were performed. A stat CBC was basically within normal limits, a urinalysis looked normal, and cultures were pending. The child was seen on 10-Nov-2005 by the physician and had some chest congestion and was fussy. Albuterol syrup was ordered and the mother was told to call if there was any change. It was noted that therapy with PROQUAD  was discontinued. At the time of the report, the patient was recovering. A product quality complaint was not involved. Fever, chest congestion, and fussy were determined to be other important medical events  by the reporter. Additional information has been requested.				Y					Y	11/07/2005	11/08/2005	1	Body temp, 11/08/05, 100.4; 11/09/05, 102.8; 11/09/05, 103; 11/09/2005, 101.3. Complete blood cell 11/09/05 basically within normal limits, urinalysis looked normal, urine culture pending.	OTH	OTH		Ear discomfort; fever	Dermatitis atopic		WAES0511USA01852	1						1	Body temperature increased; Chest discomfort; Full blood count normal; Irritability; Pyrexia; Urine analysis	FLU3~SANOFI PASTEUR~W7431A~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0482R~3~UN~UN~HIB (PEDVAXHIB)~1|MMRV~MERCK & CO. INC.~0769R~1~SC~UN~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0249891	12/28/2005	OH	1.03	1	.0	F	12/21/2005	Information has been received from a physician concerning a female who on Oct 25 2005 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella Virus Vaccine live (upgrade process) (lot 651812/0769R). ten days following vaccination, on Nov 4 2005, the patient experienced a measles like rash and a fever. Additional information has been requested. This is in follow-up report(s) previously submitted on 12/21/2005.  Information has been received from a physician concerning a 12 month old child, with no known drug allergies, who on 25-OCT-2005, at 9:00am, was vaccinated with a first subcutaneous dose of PROQUAD (Merck) (Lot # 655812/0369R).  Concomitant vaccines administered at the same time a third intramuscular done of COMBAX (Lot# 652498/0643R), a fourth intramuscular dose of PREVNAR (Lot# A85856M) and a first intramuscular dose of FLUZONE (Lot# U1753AA).  It was noted that the patient had signs and symptoms of a mild upper respiratory infection at the time of vaccination.  Ten days following vaccination.  On 06-NOV-2005, the patient experienced a measles like rash and a fever.  It was also reported that in the morning of 06-NOV-2005 the patient developed erythematous, papular lesions all over her chest and abdomen.  Subsequently the patient recovered.  Additional information is not expected.				Y					Y	10/25/2005	11/04/2005	10	Body temp 11/04/2005 fever	PVT	PVT	UNK		UNK		WAES0511USA01871	1						1	Pyrexia; Rash morbilliform	FLU3~SANOFI PASTEUR~U1753AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0643R~3~IM~UN~HIB + HEP B (COMVAX)~1|MMRV~MERCK & CO. INC.~0769R~1~SC~UN~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~A85858H~4~IM~UN~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0249907	12/28/2005	TX	82.0	82		F	12/23/2005	Large (approximately 10x5) area on left hip, abdomen, back. Area red, patchy, welts; inflamed area. Referred patient to doctor for examination.									U	12/02/2005	12/05/2005	3		OTH	PVT		NONE	NONE			1						1	Erythema; Injection site inflammation; Urticaria	FLU3~SANOFI PASTEUR~U1817AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249908	12/28/2005	SC	70.0	69		F	11/07/2005	Lip swelling, eyes itching, palm itching, throat, tongue, lips itchy. Took 2 doses of Benadryl 50mg each dose.									Y	11/05/2005	11/05/2005	0	NONE	OTH	PVT		NONE	NONE			1						1	Eye irritation; Face oedema	FLU3~SANOFI PASTEUR~U191AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249909	12/28/2005	NY	67.0	66		F	12/23/2005	Developed palpable purpura over lower legs then over thighs, forearms and abdominal wall. Purpura of lower legs became necrotic pustules.									N	12/14/2005	12/16/2005	2	CBC; WBC increased (14.800).	PVT	PVT	Behlcar; Imdur; Coreg; Zetia	Hyperlipidemia	Hyperlipidemia; Hypertension			1						1	Purpura; Rash pustular; Skin necrosis; White blood cell count increased	FLU3~SANOFI PASTEUR~U1836AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0192424	12/29/2005	CA	54.0	53		M	10/18/2002	The patient developed Sepsis. Pancytopenia due polyclonal Gammopathy. The patients family suspect the flu vaccine is the cause of his illness. He required plasmapheresis to remove gamma globulin.			Y						U	09/28/2002	10/14/2002	16		UNK	UNK	Glucophage; Glucotrol; Nizoral; Decapro					1						2	Globulins increased; Pancytopenia; Sepsis	FLU3~SANOFI PASTEUR~E31972GA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening	Influenza
0249746	12/29/2005	FL	59.0	59		M	12/28/2005	On 10/27/05 employee received Fluzone vaccine for flu prevention at work. Employee is a physcian assistant. On 12/02/05, employee noticed tearing in left eye (excessive), followed by left sided facial paralysis				Y					N	10/27/2005	12/02/2005	36	Seen in JFK Hospital, Atlantis, Fl on 12/02/05 by neurologist, opthmalogist on 12/05/05. Pt diagnosed with Bell's Palsy with optic nerve involvement.	PUB	PUB			allergy to flagyl, developed rash after use			1						2	Dysarthria; Eye disorder; Facial palsy; Facial palsy; Lacrimation increased; Facial palsy; Lacrimation increased; Nervous system disorder	FLU3~SANOFI PASTEUR~41755AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~41755AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0249862	12/29/2005	WI	7.0	6		F	12/28/2005	Mom called office 1 hour after child received vaccine states she felt dizzy and nearly fainted. Also reported increased irritability.									Y	12/27/2005	12/27/2005	0	NONE	PVT	PVT	NONE	NONE	Sulfa allergy			1						1	Dizziness; Irritability	FLU3~SANOFI PASTEUR~U1929AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249863	12/29/2005	KS	27.0	26		F	12/23/2005	Mon at 3:15 had PNE vaccine. Woke up Tues morning with pain and swelling with 4 long x 2 wide 4 high, accompanied by NALKLA, fatigue. By Wed arm doubled in size. PT TX hydrocortisone, Tylenol, Benadryl.				Y					Y	12/19/2005	12/20/2005	1		PUB	UNK	Keppra, Aciphex.		Rheumatoid arthritis, Fibromyalgia, Bursitis, Hypoglycemia, Hypothyroidism, Epilepsy.			1						1	Fatigue; Oedema; Pain	FLU3~SANOFI PASTEUR~~7+~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~1~~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0249915	12/29/2005	NY	64.0	63		M	11/09/2005	Death, No cause/effect established.	Y	10/22/2005	Y						N	10/20/2005	10/22/2005	2		UNK	UNK	Diltiazem (INVOB) 240mg SA Cap;Omeprazole (Prilosec) 20mg Cap, SA;Nephrocaps Cap; Simvastatin 20mg TAB;Warfarin (Coumadin) NA 2mg tab;Lisinopril 5mg Tab;Aspirin 81mg Tab,Enteric Coated;Albuterol 90mcg 20- IMHL,Oral;Nicotine 14MG/24HR transd		Chronic renal failure, on peritoneal dialysis, Anemia of CRF, Arteriosclerotic Heart Disease and atrial fibrillation, COPD, hypertension, no cause and effect relationship has been established for this event.			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U1983AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0249916	12/29/2005	NY	69.0	69		M	11/10/2005	No cause/effect established; patient died in his sleep.	Y	10/27/2005	Y						N	10/26/2005	10/27/2005	1		UNK	UNK	Dorzolamide 2%/TIMOLOL 0.5% SOLN,OPH; Potassium Chloride (K-DUR) 20MED 3A Tab; Trinexyphenidil HCL 2mg Tab;Metoprolol Tartrate 25mg Tab;Aspirin 325mg Tab,Enteric Coated;Carbidopa 10/Levodopa 100mg Tab; Finasteride 5mg Tab;Ferrous Sulfate 32		Advanced Parkinson's Disease,  Shy Dragger Syndrome, Atrial Fibrillation. No cause and effect relationship has been established for this event. The event may have been related to an underlying condition or may have occurred by chance after a vaccine was administered.			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U1819AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0249925	12/29/2005	MA	38.0	37		F	10/18/2002	Development of headache, itchy eyes, congestion, hot flushes after receiving flu shot. No rashes or resp distress. Seen by NP. Given Benadryl 50mg PO, Pepcid 20mg PO, with lessening of symptoms sent home with instructions to take Benadryl 96 hours and Pepcid 20 mg QD x6 days.										10/15/2002	10/15/2002	0	NONE	UNK	UNK	NONE		Type II diabetes, allergy sulfa.			1						1	Eye disorder; Headache; Hot flush; Nasal congestion; Pruritus	FLU3~SANOFI PASTEUR~U0904CA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249926	12/29/2005	OR		56		F	10/24/2003	Pt with history of migraines (using Topamax for prophylaxis) developed severe migraine within 13 hours of receiving flu shot.										10/17/2003	10/17/2003	0	NONE	UNK	UNK			History of migraines but not as severe or long in duration, using Topiramate as prophylaxis.			1						1	Condition aggravated; Migraine	FLU3~SANOFI PASTEUR~U1122AA~UNK~SC~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249927	12/29/2005	NY	1.3	1	.3	M	12/23/2005	Fever for 5 days. Start 2-3 days after immunization.				Y					Y	12/14/2005	12/16/2005	2		PVT	PVT	NONE	NONE	Allergy to amoxil, HX of GERD.			1						1	Pyrexia	DTAPH~SANOFI PASTEUR~UE600AB~4~IM~RL~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~U1743HA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0603R~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0249935	12/29/2005	OH	40.0	40		M	12/29/2005	Itching watery eyes followed by rapidly worsening angioedema, urticaria and anaphylaxis within 2 hour of vaccination. Patient was treated aggressively with IM dexamethasone, Benadryl and sub cutaneous epinepherine.  Symptoms initially improved but later worsened again.  At that time IV Solumedrol was given and patient was transported to the ER.  patient was discharged from the ER on oral steroids.  Later that evening developed a local swelling with numbness and tingling in Left arm and hand with a L sided facial droop.  He was referred both to an allergist as well as a neurologist.  He currently has a vaccine induced polyneuropathy with a brachial plexus neuritis and is following with Neurology.				Y					U	12/14/2005	12/14/2005	0		UNK	UNK	proscar	none	none			1						1	Anaphylactic reaction; Angioneurotic oedema; Eye irritation; Facial palsy; Hypoaesthesia; Lacrimation increased; Paraesthesia; Polyneuropathy; Radiculitis brachial; Swelling; Urticaria	FLU3~SANOFI PASTEUR~U1770AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249939	12/29/2005	TX	40.0	40		M	12/29/2005	The client stated the day after receiving vaccinations developed raised areas on his left wrist surrounding the wrist and extending about 4 inches above the wrist. Had some itching and redness in color.  States it did not cause much discomfort and he did not seek medical assistance States symptoms lasted serveral weeks slowly improving over this period.  It has resolved.									Y	11/14/2005	11/15/2005	1	None	UNK	UNK	None Known	None	None Known			1						1	Pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~U1881AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U1616BA~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0249940	12/29/2005	CA	0.54	0	.5	F	12/29/2005	About  2.5 hours post vaccine pt had urticaria over face and body. Lungs clear. Also with some facial and eyelid swelling. Benadryl given po.				Y					Y	12/29/2005	12/29/2005	0		UNK	UNK		Pt with probable eczema.	Probable eczema and history of mild torticollis at birth.			1						1	Eyelid oedema; Swelling face; Urticaria	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~ac21b022ba~UNK~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~u17430a~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~a67184h~UNK~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0249941	12/29/2005	MO	4.0	4		M	12/29/2005	MMR given 12/26/05 - 24 hrs later developed firm, red, warm, and swollen area at inj site (left glut.) approx 4 1/2 inches x 5 inches. Dr. notified and Benadryl given. On 12/28/05 area increased to approx 8 x 5. Dr notified and Benadryl cont. On 12/29/05 area has decreased to approx 7 x 4 1/2 continuing to give Benadryl at this time.										12/26/2005	12/27/2005	1		PVT	UNK	Zyrtec 5mg every day	NONE	Seasonal Allergies	~Measles + Mumps + Rubella (MMR II)~1~0.13~In Sibling		1						1	Injection site erythema; Injection site swelling; Injection site warmth	DTAP~GLAXOSMITHKLINE BIOLOGICALS~614B9~5~IM~GM~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1870AA~2~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0496~4~SC~GM~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0608P~2~SC~GM~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0249942	12/29/2005	WY	51.0	50		M	12/29/2005	1/2 hour post injection got severe headache took asa with no relief.  5 1/2 hour post injections began trembling and had fatigue. 6 hours unable to ambulate. Within next 12 hours s/s  resolved pt did not seek medical attention.									Y	12/16/2005	12/16/2005	0		OTH	PVT		NONE	Renal Cell Carcinoma;Hyperthyroidism;Asthma			1						1	Fatigue; Headache; Movement disorder; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62926~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0249943	12/30/2005	IA	3.0	3		F	12/20/2005	No known adverse events. There were no adverse reactions or events. Therefore there is no date or time.										12/15/2005				PUB	UNK						1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61129~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0249944	12/30/2005	IA	5.0	4		F	12/20/2005	No known adverse events. There were no adverse reactions or events. Therefore there is no date or time.										12/15/2005				PUB	UNK						1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61129~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0249947	12/30/2005	CA	34.0	34		M	12/22/2005	Dec 12 shot given, Dec 21 thin red line extending medially, Dec 22 erythema expanded to cellulitis, TX with Bactrim DS x 10 days and Rifampin 600ml daily x 10 days.				Y					U	12/12/2005	12/21/2005	9	NONE	MIL	MIL	PPD	NONE	NONE			1						1	Cellulitis; Erythema	ANTH~EMERGENT BIOSOLUTIONS~~UNK~~LA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~2~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~RA~HEP B (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~~RA~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0249950	12/30/2005	NC	22.0	21		F	12/12/2005	Redness at injection site. 1st 24 hr, then spread down left arm to fingertips, pain in arm, tingling left index 3rd finger. Took Benadryl 50mg every 6 hrs without relief.				Y					Y	12/09/2005	12/10/2005	1		OTH	UNK		NONE	Asthma			1						1	Injection site erythema; Pain; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~3~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0249951	12/30/2005	MO	35.0	34		F	12/22/2005	Pt received flu shot on 20 Dec 05 that evening left arm had a large welt became hot and itching. On 22 Dec 05 pt was seen by Dr friend and diagnosed with an allergic reaction.									Y	12/20/2005	12/20/2005	0	Allergic reaction given Keflex and Atarax	OTH	MIL	NONE	NONE	NONE			1						1	Feeling hot; Hypersensitivity; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1916AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249954	12/30/2005	CT	65.0	64		F	12/30/2005	Sudden asthmatic cough, palpitating heart, chills, redness on upper arm, shoulder and chest, UNCONTROLLABLE SHAKING THROUGHOUT BODY.									Y	12/12/2005	12/12/2005	0		PUB	PUB						1						1	Asthma; Chills; Cough; Erythema; Palpitations; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0249957	12/30/2005	WI	1.63	1	.6	F	12/30/2005	DEC. 30TH, 1:30PM, WHILE MOM WAS BATHING HER, NOTICED RED, SWOLLEN AREA THE SIZE OF A SILVER DOLLAR ON R UPPER ARM.									Y	12/29/2005	12/30/2005	1		UNK	UNK						1						1	Erythema; Swelling	DTAP~SANOFI PASTEUR~U1387DA~4~IM~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~01765CA~2~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249958	12/30/2005	TX	1.51	1	.5	F	12/30/2005	Measles-like rash on face, neck, chest, abd 12 days after administration of the vaccine.									Y	12/16/2005	12/28/2005	12		UNK	UNK	None	None	None			1						1	Rash morbilliform	DTAP~SANOFI PASTEUR~0380R~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1743MA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~AC14B006BA~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0249961	12/30/2005	MO	1.1	1	.1	M	12/30/2005	Rash outbreak, hives on knees and elbows, fussy.				Y					U	12/29/2005	12/30/2005	1		UNK	UNK						1						1	Irritability; Rash; Urticaria	FLU3~SANOFI PASTEUR~u1788ea~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~0602r~1~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~a25964k~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0249965	12/30/2005	KS	59.0	59		M	12/29/2005	Itching 4-5 hrs after injection on chest, back and arms. No hives just redness and itching. Became worse as time went on at it worst 48 hr after injection. Within 72 hr began to subside. By 12-28-05 completed gone.									Y	12/22/2005	12/22/2005	0		PUB	UNK		NONE				1						1	Erythema; Pruritus	FLU3~SANOFI PASTEUR~U1881AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0249966	12/30/2005	CA	1.98	1	1	F	12/30/2005	Pt given flu shot on Dec. 2nd and developed significant knee swelling hours after the vaccine. Pt continues with arthropathy and limp. Per 60 day follow up report-probable pareci Articular juvenille rheumatoid arthritis diagnosis.					Y	1			N	12/02/2005	12/02/2005	0		PVT	UNK						1						1	Arthropathy; Hypotonia; Juvenile arthritis; Swelling	FLU3~SANOFI PASTEUR~U1861AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0249967	12/30/2005	WA	3.0	2	.6	F	12/29/2005	Pt developed Henoch Schonlein purpura 20 days post immunization.				Y					Y	11/15/2005	12/05/2005	20	Classic rash, trace hemotum 2	PVT	PUB	NONE	NONE	04/03 Ventricular Septal Defect 745.4			1						1	Henoch-Schonlein purpura	FLU3~SANOFI PASTEUR~U1743NA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249963	12/31/2005	CA	1.35	1	.3	F	12/31/2005	Pt with febrile seizure x 5 minutes.				Y					Y	12/29/2005	12/31/2005	2		UNK	UNK						1						1	Febrile convulsion	DTAP~UNKNOWN MANUFACTURER~~UNK~~~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~UNK~~~HIB (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0249972	01/03/2006	NC				U	12/28/2005	Seriousness criteria other medically significant (OMIC). This case involves a cluster of five female (no specific identification provided). The patients had all received vaccinations with Fluzone SV 2005-2005 USP on unspecified dates. The vaccines were received at the local health department and were from three different lots. No information on the specific lot numbers was provided. An unspecified amount of time following vaccination, the five women experienced intra-uterine fetal death. Two of the patients were sisters. Of the five total patients, two of the fetuses were at 37 to 40 weeks gestation at the time of fetal death, and three were 20 to 36 weeks. There was no available information on the causes of deaths in the fetuses or if autopsies are planned. It was not reported whether any of the five female patients recovered from the events.				Y					U					UNK	UNK					200502820	1						1	Abortion spontaneous; Unintended pregnancy	FLU3~SANOFI PASTEUR~~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249975	01/03/2006	IN	73.0	72		M	01/03/2006	Pt developed 2-3 blister reaction within 24 hr. pain swelling. Pt was seen rx with Prednisone, Claritin. Pt was seen again drained the tense blister clear serous fluid drained.				Y					Y	12/28/2005	12/29/2005	1		UNK	UNK	Aspirin Oral 81mg (1 tablet qd), Glucophage 500mg (1 tab po bid), Keflex 500mg (1 tab po tid), Lipitor 20mg (1 QD), Prednisone 10mg (40 MG PO ONCE DAILY X 5 DAYS), Vicodin 5-500mg (1 tablet po q 6 hours-prn pain), Zoloft 50mg (1 tab po qd)					1						1	Blister; Pain; Swelling	FLU3~SANOFI PASTEUR~U1913AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1039P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0249987	01/03/2006	NC	48.0	47		M	12/13/2005	11/21/2005 hospitalized with heart attack, underwent angioplasty and stent placement discharged from hospital 11/23/2005.				Y	Y	3			Y	11/14/2005	11/21/2005	7		PVT	UNK						1						1	Myocardial infarction	FLU3~SANOFI PASTEUR~U1777AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0249990	01/03/2006	ID	46.0	46		F	11/08/2005	Swollen, red, hot, induration at site of injection, lasted 7 days.  Not painful but tender and itched alot.				Y					U	11/01/2005	11/02/2005	1		OTH	PVT	Not known	Unknown	Allergy to sulfa		ID05045	1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U1828AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249991	01/03/2006	ID	9.0	9		F	11/16/2005	Severe headache the night after vaccine, worst headache ever - not known to have migraines.  It resolved over 6 hours - vomited once.									Y	11/15/2005	11/16/2005	1		PVT	PVT					ID05047	1						1	Headache; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500386P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0249993	01/03/2006	MO	24.0	24		M	12/13/2005	Vaccine given 11/30/2005 between 2-4pm.  On 12/02/2005. patient noted right facial weakness and mouth drooping.  He denied any numbness or tingling, slurred speech, weakness of arms or legs, difficulty swallowing.  He stated that symptoms appeared to be resolving, but he wondered if this had anything to do with recent vaccine.  Referred to MD for evaluation. 01/04/2006 per telephone f/u with reporter diagnosis was Bells Palsy and sinsus infection. Sinusitis was treated with Zithromax.				Y						11/30/2005	12/02/2005	2		OTH	UNK						1						1	Facial palsy; Sinusitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62017~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0249994	01/03/2006	CA	4.0	3		M	10/27/2005	Swollen lips, small bumps on face, arms, legs redness.  Patient has no history of adverse reaction to influenza vaccine in the past and no egg allergy.  He has a history of Pulmonary Atresia.  25 mg of Benadryl administered orally which he tolerated well.  Continued erythema and progression of urticarial rash.  Decadron administered intramuscularly.  No new hives, slow decrease in erythema.  Tranfered to ER for further management due to hypotension and poor perfusion.				Y					Y	10/27/2005	10/27/2005	0		PVT	PUB		NONE	Pulmonary Atresia			1						1	Erythema; Hypotension; Rash; Swelling	FLU3~SANOFI PASTEUR~U1854AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0249996	01/03/2006	FL	71.0			F	12/28/2005	Shot 10/21/2005 - Terrible pain down shoulder/arm after injection - felt like going to fall off.  Aching still going on - 12/28/2005, can't use right arm, very painful.									N					PUB	UNK		NONE				1						1	Hypokinesia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0250005	01/03/2006	TX	1.02	1	.0	F	12/15/2005	runny nose, cough, skin vessels torn									U	11/17/2005	12/13/2005	26		PUB	PUB	NONE	NONE	NONE		TX05106	1						1	Cough; Rhinorrhoea; Skin reaction	FLU3~SANOFI PASTEUR~U1743KA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE727AA~4~~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0033R~1~~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|PNC~PFIZER\WYETH~A98341B~4~~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1113P~1~~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0248217	01/04/2006	NE	62.0	62		F	12/30/2005	Initial report received on Dec 22 2005 from another manufacturer, report WAES0511USA03324. A 62 year old female patient with a history of hypertension was vaccinated in the left deltoid with her first dose of Fluzone no preservative 2005-2006, lot number U1825EA and in the right deltoid with a 0.5 ml first dose of another manufacturers Pneumovax 23 vaccine, lot number 650082/0691P on Nov 10 2005. On Nov 12 2005 at 8:30 the patient was seen by a physician and presented with redness and swelling at the injection site and under arm. Her diagnosis was adverse reaction to vaccination. No laboratory test were done and treatment included hydroxyzine hydrochloride (Atarax). At the time of this report, the patient was recovering.				Y					N	11/10/2005	11/12/2005	2		PVT	PVT	Lipitor, Plavix.		The patient has a pre existing condition of hypertension.		200502854	1						2	Injection site hypersensitivity; Injection site oedema	FLU3~SANOFI PASTEUR~U1825EA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0691P~1~~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0249980	01/04/2006	PR	44.0			M	12/14/2005	None stated									N					MIL	MIL			NONE			1						1	Vaccination failure	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|YF~UNKNOWN MANUFACTURER~~UNK~~~YELLOW FEVER (NO BRAND NAME)~1	USA		Influenza
0250028	01/04/2006	NE	67.0	66		F	12/30/2005	Case received form another manufacturer on Dec 22 2005 under the reference number WAES0511USA01987. It was initially reported by a health care professional that a 66 year old female patient received a dose of Fluzone no preservative 2005-2006, lot number U1825EA, intra muscularly in the left deltoid and a dose of Pneumovax 23, lot number 651318/1006P, intra muscularly in the right deltoid. The next day, the patient developed a fever of 102 degrees F. In addition, she had redness, swelling, pain and warmth of her right arm. She was seen by a physician on Nov 10 2005 and was diagnosed with Cellulitis of the right arm. It was noted that her right arm was red and raised and demarcated ion the leading margin. She had tenderness of the right upper arm. She was treated with telithromycin (Ketek) for nine days and Allegra D for 10 days. It was noted that the patient was unable to work and the reporter considered the events to be disabling and an other important medical event (OMIC). The events associated with the cellulitis were limited to the arm in which the Pneumovax 23 was administered. The patient has not recovered from the events.				Y					N	11/09/2005	11/10/2005	1		PVT	PVT	Crestor				200502850	1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Injection site pain; Injection site reaction; Injection site swelling; Injection site warmth; Pyrexia; Tenderness; Cellulitis; Injection site erythema; Injection site reaction; Injection site swelling; Injection site warmth; Pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U1825EA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1006P~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U1825EA~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1006P~1~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0250038	01/04/2006	SC	70.0	70		F	01/04/2006	Patient received Fluzone and Pneumovax in left deltoid at 11:00am on 10/21/05.  Later that evening her left arm became very painful, red and swollen.  She sent to the ER that evening and then x2 on 10/22/05 with continued pain				Y					Y	10/21/2005	10/21/2005	0	NONE	UNK	UNK	UNKNOWN	NONE	NONE		SC0532	1						1	Erythema; Pain; Swelling	FLU3~SANOFI PASTEUR~U1836AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0346R~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0250040	01/04/2006	SC	79.0	79		M	01/04/2006	Patient received flu vaccine on 10/21/2005, about 3 hours later, experienced raised, red bumps on left side of her face with pain and itching and complaint of headache.  Went to local ER and then to MD.  Diagnosed as shingles.				Y					Y	10/21/2005	10/21/2005	0	NONE	UNK	UNK	UNKNOWN	NONE	Allergic to penicillin		SC0533	1						1	Headache; Herpes zoster; Pain; Pruritus; Rash	FLU3~SANOFI PASTEUR~U1836AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250041	01/04/2006	SC	7.0	6		F	01/04/2006	6 year old patient received flu shot on 11/29/2005 in left arm at mass flu clinic.  He was restrained by his father during the injection.  Parents state he had pain in left arm after the injection and has been unable to move left arm or hand since he received the injection.  He was taken to ER on 11/2, 11/6, and 11/7.  Received Tylenol with Codeine and Prelone prescriptions.				Y					U	10/29/2005	10/29/2005	0	X-rays of left arm on 11/6.	UNK	UNK	NONE	NONE	NONE		SC0534	1						1	Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U1831AB~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250042	01/04/2006	KY	19.0			M	01/04/2006	Patient has had some abdomen pain with elevated pancreatic enzymes 14 days after receiving FluMist vaccine.				Y	Y	10			Y					MIL	MIL	None	None	None			1						1	Abdominal pain; Pancreatitis	FLUN3~MEDIMMUNE VACCINES, INC.~500393P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0250044	01/04/2006	SC	77.0	76		F	01/04/2006	Reported dizziness after getting shot.  Helped to lay down on exam table.  Blood pressure 140/80.  Pulse 120.  Complained of some chest pain.  Transported via ambulance to emergency room.				Y					U	11/15/2005	11/15/2005	0	NONE	UNK	UNK	UNKNOWN	NONE KNOWN	History of 2 triple bypass surgeries.  Defibrillator placed.		SC0535	1						1	Blood pressure increased; Chest pain; Dizziness; Heart rate increased	FLU3~SANOFI PASTEUR~U1831AB~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250045	01/04/2006	SC	67.0	67		F	01/04/2006	Ecchymosis of deltoid extending halfway down upper left arm.  Experienced dizziness the morning of 11/17/05 and bruising at site of injection which slowly progressed down left arm.				Y					Y	11/16/2005	11/17/2005	1	NONE	UNK	UNK	NONE	NONE	NONE		SC0536	1						1	Contusion; Dizziness; Ecchymosis	FLU3~SANOFI PASTEUR~U1914AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250046	01/04/2006	SC	60.0	59		F	01/04/2006	On 12/03/05 patient got up as usual, had coffee, then experienced difficulty talking.  Unable to communicate to friends what was wrong.  Went to ER and experienced a seizure.  According to patient he does not remember what happened after that.  Next thing he remembered was waking up in hospital bed. 1/5/06 review of 2-page d/c summary indicates final diagnosis of new onset seizure disorder and mild gait ataxia. Review of medical record confirms new onset seizure diagnosis.					Y	3			Y	11/16/2005	12/03/2005	17	Hospital ruled out CVA 1/5/06 Per review of medical records - EEG was described as abnormal.	UNK	UNK	Welcohl for hypertension; Cozar	NONE	Hypertension;  elevated liver enzymes		SC0537	1						1	Convulsion; Coordination abnormal; Electroencephalogram abnormal; Loss of consciousness; Speech disorder	FLU3~SANOFI PASTEUR~U1872AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0250047	01/04/2006	SC	33.0	32		F	01/04/2006	Complained of pain at right arm injection site at time of injection and continues to have pain that runs down arm on daily basis.  No fever, no redness at injection site.  Referred to private MD for follow-up.									U	10/07/2005	10/07/2005	0	NONE	UNK	UNK	NONE	cold, nasal drainage, congestion, no fever	history of asthmatic bronchitis, no birth defects, no known allergies		SC0538	1						1	Injection site pain	FLU3~SANOFI PASTEUR~U1747AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~MASS. PUB HLTH BIOL LAB~Td120~1~IM~RA~TD ADSORBED (TDVAX)~1	USA		Influenza
0250048	01/04/2006	KY	60.0	60		F	12/15/2005	C/O dizziness for 4 days, nausea, afebrile, body aches.									Y	11/26/2005	11/26/2005	0		UNK	UNK		N/A	Fibromyalgia and Htn		KY2006002	1						1	Dizziness; Nausea; Pain	FLU3~SANOFI PASTEUR~U1830AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250050	01/04/2006	MD	19.0	19		F	01/04/2006	ON 3 JAN 06, AT 09:00, PT RECEIVED 2ND DOSE OF HEP A IN UPPER LEFT ARM, AND FLU VACCINE IN LOWER LEFT ARM. PT RETURNED TO SICK CALL TODAY COMPLAINING OF REALLY ITCHY BUMPS ON BILATERAL TRICEPS REGION, NECK, BREASTS, UPPER AND LOWER TORSO AND BILATERAL THGHS. PT HAD NO OTHER COMPLAINTS. PT WAS SEEN BY HEALTH CARE PROVIDER FOR FOLLOW UP CARE.				Y					Y	01/03/2006	01/03/2006	0		MIL	MIL		NONE NOTED	NONE NOTED			1						1	Rash	FLU3~SANOFI PASTEUR~U1858CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVBO32BA~2~IM~LA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0250051	01/04/2006	KY	19.0	19		M	01/04/2006	Patient had pancreatic tail erosion on CT and elevated Amylase & Lipase enzymes.				Y	Y	11			Y	11/14/2005	11/25/2005	11	Pancreatic enzymes, CT scan	MIL	MIL	none	none	none			1						1	Blood amylase increased; Lipase increased; Pancreatic disorder	FLUN3~MEDIMMUNE VACCINES, INC.~500393P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0250052	01/04/2006	MN	43.0	43		F	01/04/2006	Shot given at 10:30 am, lunch of sandwich at 11:00 am.  1:00 pm feel moderately dizzy.  No other symptoms at this time. No treatment given.  Will call doctor if symptoms increase or last more than a few hours.										01/04/2006	01/04/2006	0		UNK	UNK	Ortho Novum 7/7/7 Paxil 10 mg	None	None			1						1	Dizziness	FLU3~SANOFI PASTEUR~U1917AA~1~ID~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250058	01/04/2006	NY	0.88	0	.9	M	01/04/2006	That evening after getting flu vaccine child cried screamed - high pitched cry, would start and stop every few minutes.									Y	11/21/2005	11/21/2005	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	High-pitched crying	FLU3~SANOFI PASTEUR~U1867CA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250065	01/05/2006	NY	27.0	27		M	11/22/2005	Right upper arm erythema and induration with extension to the axilla, associated with axillary adenopathy. Fevers and chills noted at onset of symptoms. PCP prescribed Keflex.									Y	11/14/2005	11/14/2005	0	Temp 37.3 C	OTH	PVT		NONE	NONE			1						1	Chills; Erythema; Injection site induration; Lymphadenopathy; Pyrexia	FLU3~SANOFI PASTEUR~U1910AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0748P~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0250066	01/05/2006	FL	47.0	46		F	12/20/2005	Shortness of breath, dizziness, numbness of face, hands, legs, feet, shaking, elevated blood pressure, itching, dry mouth and throat, difficulty swallowing. Symptoms began within two hours of receiving flu shot.				Y					Y	12/15/2005	12/15/2005	0	To ER, received IV Benadryl, observed for 24 hours and released. Returned to look 12/19/2005.	OTH	PVT		NONE				1						1	Blood pressure increased; Dizziness; Dry mouth; Dry throat; Dysphagia; Dyspnoea; Hypoaesthesia; Pruritus; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62938~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0250067	01/05/2006	IL	55.0	55		F	12/28/2005	Flu-like symptoms for about 2-3 days, Not severe.									Y	10/20/2005	10/20/2005	0		OTH	PVT			Heart, Diabetes, Arthritis, allergies.			1						1	Influenza like illness	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0250073	01/05/2006	PA	50.0	50		F	01/05/2006	Left arm red raised area 2 1/2 x 3 3/4, chest tight went to ER Keflex 500mg x 2 Benadryl 25mg BID.				Y					Y	12/07/2005	12/08/2005	1	NONE	PVT	PVT	Atenolol, ASA	Hypertension	NONE			1						1	Chest discomfort; Erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U1827AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250074	01/05/2006	MD	50.0	50		F	01/05/2006	Dime sized nodule in large adipose deposit of left upper arm where Fluzone injection reportedly given.  Reports discomfort when lies on left side or pushes at site.  Injection more than 30 days ago.									U	12/01/2005	12/01/2005	0		UNK	UNK		Not reported				1						1	Discomfort; Injection site mass; Injection site pain	FLU3~SANOFI PASTEUR~UA1833AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250075	01/05/2006	TX	26.0	25		F	01/05/2006	Patient received flu vaccine on 12/29/2005 and began to run low grade temp and broke out in rash on 12/30/2005.  Rash was located on trunk and arms.   No history of egg allergy. (1/4/2006)The rash if fine, macular, slightly raised, no vesicles, warm to touch. More on arms and legs last weekend and now mainly on back (1/4/2006). Calamine lotion and benadryl recommended.									Y	12/29/2005	12/30/2005	1		UNK	UNK			Pregnancy			1						1	Feeling hot; Pyrexia; Rash erythematous; Rash macular	FLU3~SANOFI PASTEUR~U1814AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250079	01/05/2006	NY	38.0	37		F	01/05/2006	Influenza vaccine administered on 1/3/06 at 11 AM. At 3 AM on 1/4/06, patient went to hospital ER, with complaints of circumoral cyanosis, oral temperature of 103.3, generalized muscle aches particularly across shoulder blades and lower back, lethargy, and chills. Stated that she was given oral ibuprofen in ER. Today, 1/5/06, she is still complaining of generalized muscle aches. She stated that this was the first time she had ever received the influenza vaccine. Also reported today, 1/5/06, that she later recalled that she often gets headaches when she eats eggs.				Y					Y	01/03/2006	01/04/2006	1	None	UNK	UNK	Altace 2.5 mg PO daily  Synthroid 50 mcg PO daily	None	Hypertension, Hypothyroidism			1						1	Chills; Cyanosis; Headache; Lethargy; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1935AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250080	01/05/2006	PA	45.0	45		F	01/05/2006	From Thursday 12/22/2005 through Friday 12/30/2005 I felt tired and run down.  On Saturday, 12/24/2005, I started getting cold sores.  The cold sores were a severe case covering both my upper and lower lips.  I have not had such a bad case since I was 14 years old and did not protect my lips from the sun.  On Thursday, 12/29/2005 I started sneezing and had a runny nose, only in my left nostril, which continued for 2 days.  Currently I feel OK.									Y	12/21/2005	12/24/2005	3		UNK	UNK	none	none	none			1						1	Fatigue; Herpes simplex; Rhinorrhoea; Fatigue; Mouth ulceration	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500386P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0250081	01/05/2006	TN	48.0	47		F	01/05/2006	10/25/05 Received flu shot in right deltoid. Soreness in deltoid after injection. 12/30/05 Notified supervisor of soreness in deltoid. Hurting off and on in that deltoid muscle ever since that time. 1/4/05 Spoke with clinic. Denied redness, rash, inflammation, numbness, fever, loss of arm use in right upper arm.									N	10/25/2005	10/25/2005	0	None	UNK	UNK	Estrogen patch Levothyroxine 0.05mg PO daily	None	Hypothyroidism			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U1811AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250082	01/05/2006	NY	75.0	74		F	01/05/2006	Pt states 2 days after vaccine administered had redness, swelling, itching, cellulitis in area Pneumococcal vaccine administered.									Y	12/28/2005	12/31/2005	3	NA	UNK	UNK	Hyzarr 50/12.5mg Crestor 10mg	Well Adult	Sulfa			1						1	Cellulitis; Injection site erythema; Injection site hypersensitivity; Injection site reaction; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U1936AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1048P~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0250084	01/05/2006	FL	63.0	62		M	01/05/2006	Cold Hands & Feet two weeks after flu shot, then numbing of hands and feet from elbows down and knees down. numb spot on back. feet are still numb as of this date, but improving.  Lost weight as I could not eat. first Doctor I went to said I had GERD and gave me the purple pill, but could not tell me why my feet and hands were numb. Internal med Doctor took Blood test, Xrays, Cat scan, MRI and referred me to a neurologist and I had a Spinal Tap on March 12,2003 and was told I had GBS, which still lingers today. No more flu shots!!!!!!!!! Medical records state decreased reflexes,abnormal gait. msv				Y					Y	10/15/2002	11/01/2002	17	spinal tap Medical records state lab tests abnormal, CSF abnormal. msv	UNK	UNK	High blood pressure meds	none	High blood pressure Medical record states GI disorder, carcinoma of prostate. msv			1						1	CSF test abnormal; Gait disturbance; Gastrooesophageal reflux disease; Guillain-Barre syndrome; Hypoaesthesia; Hyporeflexia; Laboratory test abnormal; Oral intake reduced; Peripheral coldness; Weight decreased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0249843	01/06/2006	PA	1.8	1	.8	F	01/03/2006	Initial report received on 23/Dec/2005 from a physician. A 22 month old female patient with a concurrent illness of Respiratory Syncytial Virus at the time of the vaccination and a medical history of being a carrier for Glucose-6-Phosphate Dehydrogenase (G6PF) deficiency had received an intramuscular injection of DAPTACEL, lot number C2325AA (site not reported) and an intramuscular injection of FLUZONE No preservative '2005-'2006, lot number U1743IA (site not reported) on 14/Dec/2005 at 10:00. 24 hours post-vaccination the patient developed a temperature of 105.0 degrees Fahrenheit and then had a seizure for 15 seconds. At the time of this report the patient had recovered from these events. (OMIC)				Y					Y	12/14/2005	12/15/2005	1	The patient was positive for Respiratory Syncytial Virus.	PVT	PVT			Per the reporter, the patient had a questionable upper respiratory infection at the time of the vaccination. She has a medical history of being a carrier for Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency. Use of other medications were not reported.		200502858	1						2	Convulsion; Pyrexia; Respiratory disorder	DTAP~SANOFI PASTEUR~C2325A~4~IM~UN~DTAP (DAPTACEL)~2|FLU3~SANOFI PASTEUR~U17431A~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0250085	01/06/2006	MI	44.0	43		F	01/06/2006	Please help me and let me know if anyone else has complained about severe arm pain that has persisted over a month after receiving the flu vaccine.  Hours after I got the shot (back in November, the week before Thanksgiving) my arm started to hurt and got progressively worse until I could barely use it.  I can barely pick things up or reach with the arm that I was vaccinated in.  My doctor told me that it was tendonitis, but I never had this prior to getting the flu shot.  I had a flu shot last year and had no problems.  I called the Health Department and they said they had received 2 other complaints like mine.  I have sat in the whirlpool and soaked my arm in warm water, taken motrin, and slept with a heating pad around it. PLEASE LET ME KNOW WHAT I SHOULD DO.  I HAVE BEEN SUFFERING WITH LIMITED USE OF MY LEFT ARM FOR GOING ON 2 MONTHS NOW.  PLEASE HELP ME.  THANK YOU.				Y					N	11/21/2005	11/22/2005	1		UNK	UNK	none.	none	none			1						1	Hypokinesia; Pain; Tendonitis	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0250089	01/06/2006	WA	3.0	3		M	01/04/2006	Red, swollen, arm 2 days later, pt treated with antibiotics.				Y					Y	01/02/2006	01/04/2006	2		PVT	PUB			Reactive airway disease			1						1	Erythema; Oedema	FLU3~SANOFI PASTEUR~U1868AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250100	01/06/2006	NM	34.0	34		F	12/29/2005	Severe reaction in allergic symptoms that include chronic and excruciating headaches, aches, high fever, fatigueness, and swelling to soreness where shot was given. Is currently being treated for these symptoms. Pain in right arm. Information received from the 60 day follow-up states not fully recovered have improved in symptoms still do have headaches and pain in arm. Information received from the annual follow up indicates patient has not recovered. My headaches worsened, I have migraines on a daily bases & pain so I am not sure if the shot caused me to have pain with neurological symptoms such as pain on arm and legs-numbness etc. I really don't know if the shot caused my headaches to worsen because every since I took the shot in a months time, I expereinced more pain that is chronic. Or altogehter this could be mistaken.			Y	Y	Y		Y	Y	N	11/23/2005	11/23/2005	0		PUB	OTH	NONE	Flu symptoms and dizziness	Neurological disorders			1						1	Fatigue; Headache; Hypersensitivity; Hypoaesthesia; Injection site pain; Injection site swelling; Migraine; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0250101	01/06/2006	MA	0.64	0	.6	M	12/30/2005	Vomiting pm 12/29/05. Drowsy looking per parent - 911. Vomiting occurred 2-3 hrs after vaccine administration 2 episoded of profuse, vigorous vomiting, spaced 1/2 hrs apart. According to parents he became unresponsive after  2nd episode of vomiting when EMT's arrived he was alert.  Added terms from Discharge summary rec'd 01/13/2006: Hypotonia, viral infection/sr				Y	Y				Y	12/29/2005	12/29/2005	0		PVT	UNK						1						1	Coma; Hypotonia; Somnolence; Viral infection; Vomiting; White blood cell count increased	FLU3~SANOFI PASTEUR~U1787FA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0250102	01/06/2006	VA	63.0	62		M	01/03/2006	Flu shot given approximately 8:15 AM, 10/22/05. By 6 PM, same evening, patient developed explosive, uncontrollable diarrhea lasting 5-6 days. On 11/08, patient began experiencing numbness, tingling in extremities. By 11/09, patient could no longer stand, walk. Went to ER; admitted to hospital. Diagnosed with GBS.  Information from discharge summary states gout, bone disorder  as additional symptoms. msv			Y	Y	Y	50	Y	Y	U	10/22/2005	10/22/2005	0	Informationfrom discharge summary states abnormal EMG, lab testing abnormal. msv	PVT	PVT	Atenolol; Mevacor; Lopid		Information received from discharge summary states coronary artery disease, CA of Prostate, hypertension and hyperlipedemia. msv			1						1	Abasia; Bone disorder; Diarrhoea; Gout; Guillain-Barre syndrome; Hypoaesthesia; Hypokinesia; Laboratory test abnormal; Paraesthesia	FLU3~SANOFI PASTEUR~U1861AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0250103	01/06/2006	WV	50.0			F	11/10/2005	Muscle pain				Y	Y	0			U		10/20/2005			UNK	UNK	Loratadine 10mg tab;Meclizine RCL 12 tab; Anastrozole 1mg tab		Episode of CP and Shortness of Breath			1						1	Myalgia; Asthma; Chest pain; Condition aggravated; Dyspnoea; Heart rate increased; Nausea; Oral intake reduced; Pain; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~AVENTIS PASTEUR~U1900AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0250104	01/06/2006	MI	16.0	15		F	12/16/2005	Received intramuscular injection of flu vaccine in left deltoid at 8PM at night.  Per mom almost immediately began complaining of hurt.  Per mom client continues to hurt even though daughter active - skiing, swimming, shoveling snow.  Has not given any Tylenol or Motrin.  Mom reports increased pain by touching the corner where shoulder and arm meet, has not seen doctor.  Advised needed to follow up with doctor and to call for diagnosis and  recommendations.									N	11/14/2005	11/14/2005	0		PUB	PVT	Keflex for acne	NO	NONE		MI2005051	1						1	Pain	FLU3~SANOFI PASTEUR~~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250105	01/06/2006	MI	41.0	41		F	12/02/2005	Complaint of bruise at injection site and pain at top of shoulder inside, Saturday PM and 4 days later still painful.  One week after on 10/23 complaint of excruciating pain, 8 of 10 point scale, cannot raise left arm above head without pain.  Saw physician who diagnosed tendonitis and prescribed Motrin and arm rest.  12/02/2005 follow up call states still restricted range of motion and following up with doctor.				Y					N	10/14/2005	10/15/2005	1	NONE	PUB	PUB	NONE		Allergic to bees, wasp, hornets.		MI2005050	1						1	Contusion; Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U1850AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250106	01/06/2006	MI	57.0	57		F	12/02/2005	Complaint of general soreness at injection site, then 4-5 days later pain worse, slowly increasing to throbbing.  Dressing difficult, ab and adduction causes pain.  No redness at site but had limited range of motion.  Saw doctor who recommended arm sling, Motrin and rest, throbbing continues.  Patient started 5 days after and diagnosis as acute myositis.  12/02/2005 improving.				Y					Y	10/14/2005	10/18/2005	4	NONE	PUB	PUB	Toprol xl, Prilosec over the counter	NONE	Allergy to tandril, darvon, penicillin, heart catheter dye, vicodin.		MI2005049	1						1	Hypokinesia; Injection site pain; Myositis	FLU3~SANOFI PASTEUR~U1850AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250107	01/06/2006	MI	31.0	31		F	12/02/2005	Complaint of achy normal feeling but later 10/19/2005 strong pain especially with arm hanging or moving.  Any movement increases pain.  Swelling identified by doctor at visit to clinic.  Diagnosed as inflammation of deltoid muscle.  Prescribed Darvocet, muscle relaxers, compresses.  10/28/2005 symptoms gone.				Y					Y	10/14/2005	10/19/2005	5	NONE	PUB	PUB	Unknown		Allergy to aspirin and sulfa		M12005048	1						1	Myositis; Pain; Swelling	FLU3~SANOFI PASTEUR~U1850AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250108	01/06/2006	MI	49.0	49		F	12/02/2005	Within minutes of injection had pain at site, had increasing difficulty lifting arm over head that progressed for about 2 weeks but is now resolving somewhat.  Saw doctor who stated must be bad reaction to shot but take medicine for pain as needed or Motrin.  12/02/2005 follow up call states is improving.				Y					Y	10/28/2005	10/28/2005	0		PUB	PUB	NONE	NONE	Allergy		MI2005047	1						1	Hypokinesia; Injection site pain	FLU3~SANOFI PASTEUR~U1850AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250109	01/06/2006	MI	46.0	46		F	12/02/2005	Complaint of sharp dull ache elbow to top of hand, whole arm noticed evening of injection.  Aggravated with picking up item, headsets as she is a hearing technician.  Took Motrin, no doctor visit.  12/02/2005 telephone call follow up - continues with dull ache from top of hand to elbow and some residual loss of strength.  No problem at injection site just ache.										11/09/2005	11/09/2005	0		PUB	PUB	No meds	No fever - sick 2 weeks prior.	Hayfever - no known allergies.		MI2005046	1						1	Asthenia; Pain	FLU3~SANOFI PASTEUR~U1872AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250110	01/06/2006	MI	44.0	43		M	11/21/2005	11/15/2005 States felt really bad 7-73PM night of flu shot.  Cold symptoms, chills, achy, eyes blood shot and dry.  11/16/2005 at work feeling somewhat better, eyes still blood shot.  Received Advil 11/17/2005 PM feeling much improved, eyes better.  11/21/2005 recovered.									Y	11/15/2005	11/15/2005	0		PUB	PVT	NONE	NONE	NONE		M12005043	1						1	Chills; Dry eye; Ocular hyperaemia; Pain	FLU3~SANOFI PASTEUR~U1872AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250111	01/06/2006	WY	40.0	40		F	12/29/2005	4 inch band around arm approximately 2 inches below injection site, red hot, swollen.  Neck swollen under chin area, tender to touch, no fever.  During time for reporting in office, arm decreased in color and temperature.  Patient states she received a pneumonia shot in 1994.										12/28/2005	12/28/2005	0	NONE	PUB	PVT	Ritalin, Allegra, Vanconase, Benadryl, Nexium	NONE	Anemia, Spinal cord tumor, many severe allergies, TMJ, Chronic Fatigue Syndrome, Carpal Tunnel Syndrome, Migraines, Endometriosis.			1						1	Oedema peripheral	FLU3~SANOFI PASTEUR~U1868AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1048P~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0250112	01/06/2006	OH	59.0	58		M	12/09/2005	Patient was given flu shot 10/30/2005.  Said he had muscle tenderness for approximately 3 weeks.  No redness or swelling, just sore.  On 11/23/2005 told him to contact his doctor just to check it out.  On 11/26/2005 he said the pain had disappeared.  Patient went to doctor for regular check up and was told he had an adverse reaction to the flu shot, that spread to rotator cuff.  Doctor told him to use Aleve for 3 weeks and come in to get cortisone shot.									Y	10/30/2005	11/01/2005	2		OTH	PVT	NONE					1						1	Myalgia	FLU3~SANOFI PASTEUR~U1833BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250113	01/06/2006	IA	37.0	37		F	12/29/2005	Within about 4-24 hours the patient noted her arm becoming red, painful and swollen down to her finger tips.  She had difficulty getting dressed due to the pain and edema today.									U	12/28/2005	12/28/2005	0		PUB	PVT	Unknown	NONE	Patient denied			1						1	Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~U174AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0791P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0250114	01/06/2006	NY	1.0	1	.0	M	12/29/2005	Bumps noted 12/23/05 on Abdomen/back (approx 20) with red vesicles, resolved in 1 day. 12/29/05 4 vesicles noted at vaccine site.  Some with oval red background.									U	12/16/2005	12/23/2005	7	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Blister; Injection site reaction	FLU3~SANOFI PASTEUR~U1850AA~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0464R~1~~LL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|PNC~PFIZER\WYETH~B086364~4~~~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0629R~1~~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0250115	01/06/2006	MI	72.0	72		F	10/14/2005	None stated									Y	10/10/2005	10/11/2005	1		PUB	PVT	UNK	NONE				1						1	Vaccination failure	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0790P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0250116	01/06/2006	PA	50.0	51		F	11/10/2005	Reddened, tender, and warm area developed 12-16 hours after receiving the flu shot.									Y	11/09/2005	11/10/2005	1	NONE	PVT	OTH	Sular, Advair, Aualide	NONE	Asthma, hypertension, metabolic syndrome, arthritis			1						1	Injection site erythema; Tenderness	FLU3~SANOFI PASTEUR~U1900AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250117	01/06/2006	MI	77.0	77		M	10/14/2005	Patient received pneumonia vaccine 10/11/05 on 10/12/05 area (L deltoid) was painful and red.  Patient noted streaks; reported to Health Department.  I referred him to his physician.  Upon follow-up with patient, I found his physician had him take allergy medicine and redness and pain subsided.									Y	10/11/2005	10/12/2005	1	None known	PUB	PVT		NONE				1						1	Injection site erythema; Pain	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0790P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0250118	01/06/2006	MA	54.0	54		F	11/23/2005	11/9/05 received Fluzone.  1st got very sore arm.  Then got sore throat next day very achy.  No fever.  Very sore throat and got worse.  Aches continued and cough, bronchitis & conjunctivitis									Y	11/09/2005	11/09/2005	0		PUB	PUB	Synthroid	NONE	Euthyroid			1						1	Bronchitis; Conjunctivitis; Cough; Myalgia; Pain; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U1854AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250119	01/06/2006	ND	5.0	4		F	12/28/2005	2 cm swelling from an injection in R deltoid on 12-13-05.  Mother noticed it day of injection.  Decreasing in size.  redness and warmth.  Rash noted on trunk-more pronounced on back.  Slept most of day on 12-16-05.  Had 2 injections in each arm L and R.									Y	12/13/2005	12/13/2005	0	NONE	PUB	PVT	Nasonex, Prevacid, Adderale, Singular	NONE	No known allergies, meds, ADHD		ND0513	1						1	Erythema; Feeling hot; Rash; Swelling	DTAP~SMITHKLINE BEECHAM~C1996AA~2~IM~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1849AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1189-2~2~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0345P~2~SC~RA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA		Influenza
0250143	01/06/2006	OK	43.0	43		F	01/06/2006	Pt received influenza vaccine on Dec 9th 2005 @ 0820. She returned to work where she begin to feel itchy and feel as though she had something caught in her throat. She returned to the clinic around 1043. She was administered O2 6 liters via nasal cannula. Her vital signs were obtained. At 1050 she was given Benadryl 25mg IM and 0.3 of epinephrine. At 1100 doctor ordered 40 mg of Solumedrol IM be given. At 1103 doctor ordered 0.3ml epinephrine IM be given. Pt was transferred to hospital.				Y					Y	12/09/2005	12/09/2005	0		MIL	MIL			allergic to Keflex, Amoxicillin, and PCN			1						1	Pruritus; Throat tightness	FLU3~SANOFI PASTEUR~U1935AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250145	01/06/2006	OH	56.0	55		F	01/06/2006	Client had a Grand Mal seizure on 12/28/06.  Client didn't have a history of seizures before this. Medical records state sleep apnea, snoreing.					Y	1			Y	12/21/2005	12/28/2005	7	Medical records state abnotmal EEG. msv	UNK	UNK			Medical records state GI Disease, anxiety, rhinitis, allergy, insomnia. msv			1						1	Electroencephalogram abnormal; Grand mal convulsion; Sleep apnoea syndrome; Sleep disorder	FLU3~SANOFI PASTEUR~1872AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0250155	01/06/2006	SD	53.0	53		F	01/06/2006	Redness, swelling, hot - 4x2 inches with numbness and tingling index in middle finger.  Nausea, vomiting, diarrhea for 24 hours after vaccine.  Symptoms are resolving.									N	12/30/2005	12/31/2005	1	NONE	PVT	PVT	Unknown	NONE	NONE			1						1	Diarrhoea; Hypoaesthesia; Nausea; Oedema peripheral; Paraesthesia; Vomiting	FLU3~SANOFI PASTEUR~U1913AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250148	01/07/2006	MA	33.0	33		M	01/07/2006	Flat rash to face and neck within 24 hours of recieving flu vaccine.									N	12/03/2005	12/04/2005	1		MIL	MIL	Lisinopril	Cough, sore throat	Hypertension			1						1	Rash	FLU3~SANOFI PASTEUR~U1911AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250151	01/08/2006	MI	57.0	56		M	01/08/2006	11-13-2005 to 11-19-2005 Hospital admission. Diagnosis:  Idiopathic Thrombocytopenic Purpura  Symptoms: Dense cutaneous petechiae on feet & ankles. Large bullous hemorrhages on buccal mucosa.  Occasional petechiae on face, wrists and back. Symptoms were first noticed in the morning of 11-12-2005.  Treatment: ER  11-13-2005   Blood Test, 3:30 PM  Platelet Low 4,000,  Received: Steroid IV  2 - Chest x-ray's            Blood Test, 5:51 PM Platelet Low 2,000,  11-14-2005 Blood Test, 6:25 AM Platelet Low 1,000,       Received: Prednisone 100mg/day:            Protonix 40 mg/once daily IV- Rho(D) Immune Globulin       250ml over 30 minutes:        Ultra Sound-spleen, liver, 11-15-2005 Blood Test, 12:35 PM Platelet Low 1,000,       Received: Prednisone 100mg/day:     Protonix 40 mg/once daily 11-16-2005 Blood Test, 5:00 AM Platelet Low 1,000,       Received: Prednisone 100mg/day:     Protonix 40 mg/once daily             IV-Platelets Volume 250   (Donor P72919) 11-17-2005 Blood Test, 6:00 AM Platelet Low 1,000,       Received: Prednisone 100mg/day:     Protonix 40 mg/once daily       Bone Marrow Biopsy 11-18-2005  Received: IVIG, 1000ml, 100grams         Blood Test, 4:29 AM Platelet Low 4,000,       Received: Prednisone 100mg/day:     Protonix 40 mg/once daily 11-19-2005  Blood Test, 4:00 AM  Platelet Low 60,000,       Received: Prednisone 100mg/day:     Protonix 40 mg/once daily 11/21/05 Blood Work, Platelet  241,000  12/09/05 Blood Work, Platelet 283,000        12/20/05 Blood Work, Platelet 280,000			Y	Y	Y	7			Y	11/05/2005	11/12/2005	7	11-13-2005   Blood Test, 3:30 PM  Platelet Low 4,000, 11-14-2005   Blood Test, 6:25 AM  Platelet Low 1,000, 11-15-2005  Blood Test, 12:35 PM  Platelet Low 1,000, 11-16-2005  Blood Test, 5:00 AM  Platelet Low 1,000, 11-17-2005  Blood Test, 6:00 AM  Platelet Low 1,000, 11-18-2005      Blood Test, 4:29 AM  Platelet Low 4,000, 11-19-2005  Blood Test, 4:00 AM  Platelet Low 60,000, 11/21/05        Blood Test,         Platelet  241,000,  11/17/05  Left Iliac Bone Marrow Biopsy, Cellular Bone Marrow with increased megakaryocytogenesis.  The bone marrow biopsy is adequately cellular with maturing trilinear hematopoiesis, and increased megakaryocytogenesis.  There is no dysplasia identified.  The presence of increased megakaryocytogenesis in the marrow with thrombocytopenia suggested a peripheral destruction of platelets.  RBC: Microcytosis, polychromatophilia. WBC: No significant abnormalities. Platelets: No significant abnormalities. Erythrocytogenesis: Adequate and maturing. Myeloid Leukogenesis:  Adequate with orderly maturation. Sideroblast count is 19%, Prussian blue. Storage Iron:  Decreased, 1+/4+, Prussian Blue stain. Megakaryocytogenesis: Increased (10/hpf). M:E Ratio (Smear) is: 1.9:1  11/14/05 Ultra Sound-spleen, liver.  11/13/05 Chest X-Ray, two views.	UNK	UNK	Atenolol 25 mg / Twice Daily	Diarrhea	No Allergies, birth defects. Irregular Heart Beat ( Benign PVC's) Gilbert Syndrome Hypertension			1						1	Marrow hyperplasia; Megakaryocytes abnormal; Mouth ulceration; Petechiae; Platelet count decreased; Thrombocytopenic purpura	FLU3~SANOFI PASTEUR~U1763AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0249935	01/09/2006	OH	40.0	40		M	01/05/2006	Initial report received on 29/Dec/2005 from a physician. A 40 year old male patient with no known allergies or history of egg allergies, had received his first administration (route not reported) of Fluzone SV '2005-'2006 USP lot number U1770AA, in the left deltoid on 14/Dec/2005. Within two hours post-vaccination the patient developed anaphylaxis and angioedema. He was seen by a physician multiple times and at some point was diagnosed with polyneuropathy and brachial plexus neuritis that was secondary to angioedema. He is currently being followed by a neurologist. Allergy testing was completed (date not reported and the results are pending. The patient had not recovered from these events at the time of this report. (OMIC)				Y					N	12/14/2005	12/14/2005	0		PVT	UNK	Proscar				200502870	1						2	Anaphylactic reaction; Angioneurotic oedema; Neuritis; Polyneuropathy	FLU3~SANOFI PASTEUR~U1770AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0250080	01/09/2006	PA	45.0	45		F	01/05/2006	Patient was given Flu Mist shot on 12/21/2005.  From Thursday, 12/22 through Friday, 12/30 patient felt tired and run down.  On Saturday 12/24 patient started getting cold sores.  The cold sores were a severe case covering both the upper and lower lips.  Patient had not had such a bad case since she was 14 years old and did not protect her lips from the sun.  On Thursday, 12/29 patient started sneezing and had a runny nose, only in the left nostril, which continued for 2 days.  Patient is currently feeling okay.									Y	12/21/2005	12/22/2005	1	N/A	OTH	UNK						1						2	Fatigue; Herpes simplex; Rhinorrhoea; Fatigue; Mouth ulceration	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500386P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0250103	01/09/2006	MD	50.0	50		F	01/09/2006	TITLE: TRIAGE NOTE DATE OF NOTE: OCT 23, 2005@11:05 ENTRY DATE: OCT 23, 2005@11:05:41  Temp: 97.3 Blood Pressure:   Systolic : 155   Diastolic: 78 Pulse: 68; Resp: 20; O2 Saturation: 98Room Air Chief Complaint (List any treatments prior to coming to hospital):EPISODE OF CP AND SHORTNESS OF BREATH AFTER GETTING FLU SHOT ON THURSDAY.  TREATED AT HOSPITAL THAT NIGHT, DIAGNOSED W/ POSSIBLE ASTHMA ATTACK.  I'VE NOT FELT RIGHT SINCE.  PLACED ON PREDNISONE AT THAT TIME.SHORT WINDED, CAN'T EAT, CAN'T SLEEP,  I FEEL LIKE MY HEART IS RACING, PAIN IS A CONSTANT 7-8 ON 1-10 SCALE, CENTER OF CHEST. TAKING NOTHING FOR PAIN.      ************************************* TITLE: PHYSICIAN ER NOTE DATE OF NOTE: OCT 23, 2005@11:41 ENTRY DATE: OCT 23,2005@11:41:26        Chief Complaint: chest pain, 7-8/10 Present Illness: This is a 50yo, FEMALE, came to ER with: no cough, sometimes worse with breathing.  Not taking anything for pain  now.  radiation: none.  prior hx of same: none  heart hx: none.  Pain doesn't seem to be related to movement.  Some nausea at times.  Fever: none.  Lung hx: asthma, under tx.  Denies rashes.  Smoke: none.  Got flu shot on Thursday.  Pain in chest came on like asthma attack precipitated by smoking, used albuterol and still had pain.  Has had pain nonstop since Thursday PM, never has gone away.  Legs: no swelling. Has had prior steroid tx without any palpitations or nausea.  Allergies: AMOXICILLIN Physical exam: General: ambulatory, awake, alert, speech clear HEENT: No jvd  no icterus  Lungs: clear to p and a  no rhonchi or wheezes Heart:  RSR, no murmurs, no gallop chest wall: some left parasternal tenderness of inferior sternum. no vesicular rash  healed surgical scars times three left breast, nontender Abdomen: soft, non tender, positive bowel sounds, liver and spleen are not palpable. Extremities: No edema.  bilat no calf tenderness, Homan's neg bilat radial pulses wnl bilat.  Assessment:  chest wall pain, costochondritis, doubt cardiac origin, initial workup (DC instructions for hospital reviewed) negative, pain constant, worse with palpation, ekg today wnl, theirs wnl doubt PE: no tachycardia, sat 98% and no respiratory distress will repeat workup to re-assure patient.  She has taken nothing for  pain and should be taking meds for this.  asthma not an issue: no wheezing and good response to prednisone. Plan: Lab tests chest xray Final disposition:  pending Condition at discharge: Discharge home in stable condition, Follow up with CPC. 10/23/2005 ADDENDUM				Y					N	10/20/2005	10/20/2005	0	CBC Coll. date 10/23/05 11:46   WBC     RBC     HGB     HCT     MCV     MCH     MCHC  17.8 H  4.36    12.8 L  37.7 L  86.3    29.4    34.0  RDW     PLT     MPV      13.4    313     8.1  CHEM 7 Coll. date    10/23/05 11:46   GLUCOSE BUN     CREAT   SODIUM  K       CHLOR   CO2  100     19 H    0.9     137     4.0     106.7   22.0  pt has leukocytosis likely due to steroids.  Will check pa and lat cxr.10/23/2005 ADDENDUM          cpk and tropo wnl.	UNK	UNK	Active Outpatient Medications =============================== 1)   ALBUTEROL 90MCG 200D ORAL INHALE 2 PUFFS FOUR TIMES A DAY AS NEEDED TO HELP BREATHING 2)ANASTROZOLE 1MG TAB TAKE ONE TABLET BY MOUTH DAILY FOR THE TREATMENT OF BREAST CANCER	She came in for Well Woman Exam, C/O arms falling asleep at night for the last 2 weeks When she wakes up in the morning they are tingly and painful.  worse on the rt. starts in the shoulder.  She aches all over all the time.  Started Zocor and Arimidex at the same time.	1. Arthralgia   3. Anemia    4. Breast Cancer    5. Hyperlipidemia   6. Osteoarthritis            7. Gastroesophageal Reflux Disorder    8. ASTHMA W/O STATUS ASTHM    9. ALLERGIC RHINITIS NOS			1						2	Myalgia; Asthma; Chest pain; Condition aggravated; Dyspnoea; Heart rate increased; Nausea; Oral intake reduced; Pain; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~AVENTIS PASTEUR~U1900AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0250154	01/09/2006		1.53	1	.5	M	01/06/2006	9 1/2 x 10 cm area of blanching, pink area left thigh, increased warmth.  Circumference of thigh 3 cm greater than right thigh.  Able to walk okay.									Y	01/05/2006	01/05/2006	0	N/A	MIL	MIL	NONE	NONE	NONE			1						1	Feeling hot; Injection site discolouration	DTAP~GLAXOSMITHKLINE BIOLOGICALS~14B006BA~4~~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1858AA~3~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250164	01/09/2006	AZ	71.0	71		M	01/06/2006	Initial report received on 03/Jan/2006 from a consumer. A 71 year old male who received an intramuscular injection of Fluzone SV 2005-2006 USP, lot number U1773AA, expiration date 30/Jun/2006, in the arm (site not specified) in October, 2005. Approximately six weeks later, the patient developed a loss of feeling in his hands and tingling in his feet. At an unspecified time later, he was admitted to the hospital for eight days and diagnosed with GBS (Guillain-Barre Syndrome). Per the reporter, the patient had recovered from this event at the time of this report. Follow-up information received from a health care professional on 24/Jan/2006. It was reported that the patient received the FLUZONE vaccination on 25/Oct/2005 at 1:35 PM. It is unknown whether the patient had any relevant diagnostic or laboratory testing. As per the reporter, the name of the responsible physician that was provided by the patient's wife is unknown at that facility. No other information was provided at this time.					Y	8			Y	10/25/2005				UNK	UNK		Per the reporter, the patient had no illnesses at the time of the vaccination.	Medication history was not provided but the patient did have knee replacement surgery in 2005.		200600035	1						1	Guillain-Barre syndrome; Hypoaesthesia; Paraesthesia	FLU3~SANOFI PASTEUR~U1773AA~UNK~IM~AR~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0250167	01/09/2006	DC	0.65	0	.7	F	01/05/2006	Initial report received on 12/29/05 from a consumer. A seven month old female with no significant past medical history had received an administration (route not reported) of FLUZONE (lot number not reported) in the thigh on 12/2/05. Per the reporter, on 12/3/05, it was noticed that the patient was opening her arms wide, her mouth wide and shaking, not violently but noticeably. This was reported to have occurred approximately six times this day. These behaviors have continued but at the time of this report, they are more frequent but less noticeable. The episodes occur approximately 24 times a day. Per the reporter, the patient's arms are less extended when she spreads her arms open but she continues to open her mouth wide. At the time of this report, the reporter had noticed that the patient was now frequently opening and closing her hands. This occurs when the patient is active as well as when she is inactive. The patient was seen by a pediatrician on 12/9/05 and he referred the patient to a pediatric neurologist. The patient was seen by the pediatric neurologist on 12/12/05 and per the reporter, the pediatric neurologist did not feel the episodes were seizures as the patient was cognitive of her surroundings during these episodes. No treatment was recommended. At the time of this report, the patient had not recovered from these events. (OMIC)				Y					N	12/02/2005	12/03/2005	1		PVT	PVT					200502869	1						1	Abnormal behaviour; Tremor	FLU3~SANOFI PASTEUR~~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250168	01/09/2006	GA	4.0	4		M	01/04/2006	Fluzone vaccine given 10-21-05. Presented in office 12-13-05 with c/o extremity pain 5 times days. Labs ordered. Presented back in office 12-7-05 with Arthralgia and back pain and sent to ER. 12-21-05 admitted to hospital (Guillain Barre Syndrome). Per telephone follow up with reporter vaccine provider, the patient also received fluzone on 10/21/2005. Vaccine sites were not recorded for any vaccine. The patient later presented in the office on 12/3/05 (not 12/13/05) C/O extremity pain X 5 days. The AE onset date therefore was 11/28/05 (not 12/26/05). He was hospitalized from 12/21/05-12/26/05. Only fever was reported after previous fluzone immunizations in 2002 & 2003. 1/26/06 Review of 3-page d/c summary confirms GBS as final diagnosis. Additional symptoms include profuse diarrhea for 2 weeks just prior to admission, poor appetite, and weakness.  1/26/06  Review of 14-page medical record confirms GBS per neurology consult. Additional symptoms include poor appetite, fatigue, and weakness.				Y	Y	5			Y	10/21/2005	11/28/2005	38		PVT	PVT	NONE		1/26/06-per review of discharge summary Also PMH on early October of strep throat.	Fever with all vaccines~DTaP (Daptacel)~~0.00~In Patient		1						1	Arthralgia; Asthenia; Back pain; Decreased appetite; Diarrhoea; Fatigue; Guillain-Barre syndrome; Pain; Similar reaction on previous exposure to drug	DTAP~SANOFI PASTEUR~C2277AA~5~IM~UN~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1850AA~3~~~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0575~4~SC~UN~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0485R~2~IM~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Hospitalisation	Influenza
0250176	01/09/2006	MD	58.0	58		F	01/05/2006	Client states she experienced nausea, vomiting, diarrhea, dehydrated and had fever.  Saw Dr on 11/23/05 who stated to increase intake and questionable flu shot prescription.									Y	11/17/2005	11/20/2005	3		OTH	OTH	Celexa, Vitorin	NONE	NONE			1						1	Diarrhoea; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1826AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250177	01/09/2006	CT	50.0	50		F	12/30/2005	2 weeks following shot: Arms feel heavy and strange, buzzing behind knees, wrists, palpitations, residual left upper and lower extremities feelings of weakness, quivering voice, shaky legs, hands cramping.				Y					N	11/11/2005	11/24/2005	13	Exam/EKG negative, CBC/Chemo/TFTS/Lyme all negative.	UNK	UNK			Hip dysplasia, osteopenia.			1						1	Muscle spasms; Palpitations; Demyelination; Dysphonia; Erythema; Heart rate increased; Hypoaesthesia; Muscle twitching; Neuropathy peripheral; Paraesthesia; Rash; Urticaria	FLU3~SANOFI PASTEUR~U1778AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1778AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0250178	01/09/2006	MA	54.0	53		M	01/04/2006	Right deltoid muscle pain with associated polymyalgia of neck, shoulders, lower back and proximal thighs				Y					Y	11/15/2005	11/18/2005	3	Sed rate-c/o	PVT	PUB	Benicar, Lipitor, Viagra	Hypertension, hyperlipidemia	NONE			1						1	Myalgia; Red blood cell sedimentation rate increased	FLU3~SANOFI PASTEUR~U1872AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250180	01/09/2006	OH	68.0	68		F	12/21/2005	Patient c/o flushing from site of injection (RD, IM) to fingers and to neck/face area.									Y	12/21/2005	12/21/2005	0	NONE	PUB	PUB	UNK	All illness denied	Arthroscopic surgery L knee- recent, knee replaced-past			1						1	Flushing	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250200	01/09/2006	OH	3.0	3		M	01/09/2006	Mother describes child developed hives that were flat, pea-sized,what looked like a sm. blister in center and these moved around and would come and go.  Also had some swelling of eye lids, hands and left big toe and the swelling would come and go. No temp. but wouldn't eat. These symptoms developed about 26 hrs. after flu shot and lasted 1 1/2 weeks.  Did see Pediatrician on 12/10/2005 who wrote urticaria and prescribed Benedryl for the itching.  Doctor reported incident to us to report to VAERS.  Child has hx of Asthma.  Dr. recommended child not have flu shot next year or have child tested by allergist.									Y	12/07/2005	12/08/2005	1		UNK	UNK	Asthma meds. as needed - albuterol, pulmicort and singular	NO	Hx of Asthma			1						1	Eyelid oedema; Oedema peripheral; Urticaria	FLU3~SANOFI PASTEUR~U1747AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250201	01/09/2006	OH	49.0	49		M	01/09/2006	One week after flu vaccination developed numbness in hands/feet.  Weakness in extremities progressed.  Seen by PCP as well as another clinic.  Diagnosed with Guillain Barre Syndrome in Novemeber 2006.  Pt with continued weakness.  Uses walker.  Unable to perform ADLs. Medical records state pain, gait abnormal, reflexes decreased. msv I believe he still has weakness, fatigue, decreased endurance.  According to patient report.  May contact patient for further information at phone # listed.				Y				Y	N	10/11/2005	10/18/2005	7	Positive spinal tap for Guillian Barre. Several other tests performed including EMGs, MRIs, bloodwork.  24 hour urine.  2 complete neurological exams. Medical records SGOT elevated, alk phospatase elevated, lab test abnormal. Information receive from the 60 day follow-up states still being treated for GBS. Patient still very limited with ADL's. Requiring assistance.	UNK	UNK	Atenolol		No known allergies Hypertension			1						1	Aspartate aminotransferase increased; Asthenia; Blood alkaline phosphatase increased; Gait disturbance; Guillain-Barre syndrome; Hypoaesthesia; Hyporeflexia; Laboratory test abnormal; Pain	FLU3~SANOFI PASTEUR~U1846AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0250215	01/10/2006	CA	1.36	1	.4	M	01/09/2006	Swelling to left thigh with redness.				Y					U	01/06/2006	01/09/2006	3		PVT	PVT						1						1	Erythema; Swelling	DTAP~SANOFI PASTEUR~C2131AA~3~~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1787FA~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0112R~UNK~~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0250216	01/10/2006	PA	0.49	0	.5	M	01/09/2006	Child erroneously received 2nd dose of flu shot 1 week after 1st shot. There is a possibility that the first dose contained 0.5cc instead of 0.25cc. Child has not experienced any adverse reaction.									Y	12/27/2005			NONE	PVT	PVT	NONE	NONE	NONE			1						1	Medication error	FLU3~SANOFI PASTEUR~U1904AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250224	01/10/2006	TX	45.0	44		M	01/10/2006	12/02/05 flu vaccine administered noticed swelling to both hands and at injection site. 12/07/05 office visit, DX mild myalgia, local swelling right deltoid. 12/09/05 return visit symptoms improved states much better. Ache left hand is all that remained. Negative exam. 01/09/06 office visit c/o cough, sob, swelling lower extremities, referred to ER and left AMA. 01/10/06 office visit increased sob, dizziness, 3x tibial edema, increased jugular venous distention, irregular heart beat, weight increase 238, went via ambulance to hospital.				Y					U	12/02/2005	12/02/2005	0	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Cough; Dizziness; Dyspnoea; Heart rate irregular; Injection site oedema; Myalgia; Oedema; Oedema peripheral; Pain; Vasodilatation; Weight increased; Cough; Dizziness; Dyspnoea; Heart rate irregular; Injection site oedema; Myalgia; Oedema; Oedema peripheral; Pain; Vasodilatation; Weight increased	FLU3~SANOFI PASTEUR~U1866AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1866AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0250225	01/10/2006	FL	64.0	64		F	01/04/2006	Started with severe bone ache with hot/cold feelings and electrical shock feelings, then a hive like rash with itching and burning pain, finally developed into a huge, severe rash on torso and pelvic area . Pictures included.				Y					N	10/28/2005	10/30/2005	2	Also visited dermatologist tested negative for lupus and lyme disease.	PVT	PVT	Synthroid, Zocor, Glucophage	NONE	Type 2 Diabetic			1						1	Bone pain; Feeling cold; Hot flush; Paraesthesia; Pruritus; Rash; Skin burning sensation; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~U1777AA~1~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0250226	01/10/2006	OH	65.0	65		F	01/05/2006	After 24 hrs-next day: 1)L arm slight swollen and red at the site; 2)Arm moved only with difficulty and pain; 3)Lymph glands in axilla swollen and painful; 4)pain across back and down L breast when movement of arms.									Y	11/10/2005	11/11/2005	1		OTH	OTH	Vitamins, Quinine Sulfate, Estrogen patch	NONE	Metamucil, Penicillin, Phenobarbital			1						1	Erythema; Hypokinesia; Pain; Swelling; Back pain; Chest pain; Chills; Fatigue; Hypokinesia; Lymphadenopathy; Musculoskeletal pain; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U1872AH~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0815P~1~SC~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0815P~UNK~SC~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0250227	01/10/2006	WI	33.0	33		M	12/28/2005	Cellulitis- treated with Avelax and Omnicef-resolved after 6 days									Y	11/14/2005			NONE	OTH	OTH		NONE	NONE			1						1	Cellulitis	FLUX~UNKNOWN MANUFACTURER~AFLUA154BA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0250228	01/10/2006	OR	59.0	58		F		10/31/05 received shot, 11/5/05 flat in bed too tired and ill feeling to even watch TV.  Within the next week a virus attacked me.  Started with sinus headache, congestion. I did all healthy things that I could do to fight it back.  I was ill for 3 weeks.									Y	10/31/2005	11/05/2005	5		UNK	OTH	NONE	NONE	Penicillin and sulfides			1						1	Nasal congestion; Sensation of heaviness; Sinus headache	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA148B~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0250229	01/10/2006	GA	1.11	1	.1	M	01/04/2006	Patient had seizure (48hrs) within of the 2nd dose of Fluzone PF vial.  Dad stated child did not feel well before shot was checked before shot was given.				Y					Y	12/27/2005	12/29/2005	2	Had EEG at hospital	PVT	PUB	NONE	NONE	NONE			1						1	Convulsion	FLU3~SANOFI PASTEUR~U1787BA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250231	01/10/2006	NC	1.09	1	.1	M	12/27/2005	Local induration and erythema onset day of vaccine.				Y					Y	12/19/2005				PVT	PUB	Fluoride .25mg	NONE	NONE			1						1	Erythema; Injection site induration	DTAP~SANOFI PASTEUR~U13690B~4~~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1746AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0482R~4~~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~A23969A~4~~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0250232	01/10/2006	NY	76.0	76		M	01/04/2006	Nov 4 05 awoke w/ extremely bloodshot and watery eyes, Nov 14 & 29 saw Dr because of right eye-double peripheral vision, Dec 6 Awoke with double vision, Dec 7 MRI of head-normal, more visits to doctor & optometrist.  Diagnosis-lateral rectus palsy of right eye				Y					N	11/03/2005	11/04/2005	1		OTH	PUB	Aspirin, Gaestro, Digitek, Cardizem	NONE	High blood pressure, high cholesterol (normal values with meds.) Medical record states retinal disease. msv			1						1	Diplopia; Lacrimation increased; Ocular hyperaemia; Ophthalmoplegia	FLU3~SANOFI PASTEUR~U1904HH~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250249	01/10/2006	KY	42.0	42		F	11/10/2005	C/O BP elevated, dizziness x 3-4 days wich came and went, body aches.									Y	10/26/2005	10/26/2005	0		UNK	UNK		n/a	HTN		KY2006003	1						1	Blood pressure increased; Dizziness; Pain	FLU3~SANOFI PASTEUR~U1830AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250251	01/10/2006	IN	1.17	1	.2	F	01/10/2006	Parent-(mother) phoned the Health Department and informed to me that her daughter vomited today and she has contacted her doctor and needed to tell her doctor what vaccinations she recieved 1/9/06.She informed that her daughter has at this time of the call stopped vomiting. I gave her list of all vaccines that were given on this date and instructed to give the list to her infants doctor. I instructed to call us at the Health Department to follow up with us after she has followed up with doctor. Parent verbilizes understanding to talk to her physician.										01/09/2006	01/10/2006	1		UNK	UNK		None	None			1						1	Vomiting	DTAP~SANOFI PASTEUR~U1349BA~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1765FA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0338P~4~IM~RL~HEP B (RECOMBIVAX HB)~1|HIBV~MERCK & CO. INC.~0210R~4~IM~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0774P~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A56077C~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0218R~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0250256	01/10/2006	CO	73.0	72		U		Pneumonia vaccine given on 12/15/05.  By 12/18/05 infection spread to my bottom forearm.  Severe pain of 4 was where the vaccine was administered.  Went to ER at 5 on 12/18/05 and released on 12/19/05.				Y	Y	2				12/15/2005	12/16/2005	1		UNK	UNK						1						1	Injection site infection; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0250257	01/10/2006	CA	1.09	1	.1	F	12/15/2005	2.5cm x 2cm induration, redness R Anterior thigh, 2 days after shots.  Instructions: Benadryl, Motrin, warm compresses									U	12/13/2005	12/14/2005	1	NONE	UNK	UNK	NONE	NONE	NONE			1						1	Erythema; Injection site induration	DTAP~SANOFI PASTEUR~AC21BB2788~2~IM~~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U17431A~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE765AA~2~IM~~HIB (PROHIBIT)~1|PNC~PFIZER\WYETH~A5a117E~2~IM~LA~PNEUMO (PREVNAR)~1	USA		Influenza
0250258	01/10/2006	OH	1.28	1	.3	M	01/10/2006	Patient awoke from nap with welts/hives all over body, swollen.				Y					Y	01/04/2006	01/06/2006	2	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Swelling; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~2~~RL~HIB (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~4~~RL~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0248556	01/11/2006	IL	2.0	2	.5	F	01/11/2006	Pt. received Varivax & Prevnar on 11/9/05. Mom noticed bumps a week later after staying at aunts. Aunt had a dog with fleas, so attributed spot to fleabite. She noticed a scab (Pt. was itching it) with bumps around it (not sure if fluid filled). Took her to ER and was told had infection related to vaccine site and started on Keflex 1 tsp. TID for 10 days. Mom brought her to this office to be rechecked. Yellow scab with erythema and surrounding dry pustules on right upper thigh.				Y					Y	11/09/2005	11/16/2005	7	None	UNK	UNK	None	None	None			1						2	Erythema; Injection site infection; Rash	FLU3~SANOFI PASTEUR~U1787EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|PNC~PFIZER\WYETH~A98341A~4~IM~RL~PNEUMO (PREVNAR)~2|VARCEL~MERCK & CO. INC.~1110P~1~IM~RL~VARICELLA (VARIVAX)~2	USA	Emergency room visit	Influenza
0250273	01/11/2006	IA	68.0	68		M	01/04/2006	2 day history of progressive swallowing difficulty, speech changes, and  bil. numbness and tingling of hands and feet. Bulbar weakness due to Miller-Fischer Guillain-Barre variant likely due to flu shot. Received approx 12-01-05. Medical records state somnolance, decreased reflexes, tachycardia, anxiety, apnea. msv Information received from the annual follow up indicates patient has not recovered. As of November 06, patient is still on therapy for decreased grip strength and inablity to complete ADL's due to GUILLAIN-BARRE.			Y	Y	Y		Y		Y	12/01/2005	12/15/2005	14	CSF-Negative.  Nerve conduction studies and clinical exam with Respiratory failure requiring vent and 6 tube feeds. Medical records state lab test abnormal. Information received from the 60 day follow-up states he is home with G Tube feeds and assisted ambulation and ADL's per family.	PVT	PVT	Prevacid, Cholesterol		Medical records state GI disorder, hyperlipedemia. msv			1						1	Activities of daily living impaired; Anxiety; Apnoea; Asthenia; CSF test normal; Dysphagia; Gastrointestinal tube insertion; Grip strength decreased; Guillain-Barre syndrome; Hypoaesthesia; Hyporeflexia; Laboratory test abnormal; Miller Fisher syndrome; Nerve conduction studies; Paraesthesia; Respiratory failure; Somnolence; Speech disorder; Tachycardia	FLU3~AVENTIS PASTEUR~U1861AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0250285	01/11/2006	CO	38.0	37		F	01/11/2006	Asthma symptoms of wheezing, SOB, and coughing began 2 hrs after flu shot,necessitating the use of an inhaler twice within 20 minutes. Breathing then eased up and flu-ish symptoms began - aching, fever(no temp taken), nausea, shivering, cold. She felt horrible all evening. Finally fell asleep and felt OK the next morning. Normally her asthma is very mild and affects her only occasionally. She has allergies to pollens, spores, and mold.									Y	11/14/2005	11/14/2005	0	N/A	UNK	UNK	Zyrtec prn	none	Mild allergies to spores, mold, pollen.			1						1	Asthma; Chills; Cough; Dyspnoea; Feeling cold; Malaise; Nausea; Pain; Pyrexia; Wheezing	FLU3~SANOFI PASTEUR~U1865AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250286	01/11/2006	NJ	48.0	48		F	01/11/2006	Progressive drooping right eye, right cheek and right side of mouth/upper lip, decreased sensation right side of face and mouth over the course of two days. Diagnosed as Bell's palsy on ER visit on third day, and treated with course of steriods po. 3/6/06 - review of medical record confirms diagnosis of Bell's Palsy.				Y					Y	12/15/2005	12/28/2005	13	neurological examination by emergency MD	UNK	UNK	Effexor po	none	history of migraine headaches, NKA	local swelling~Influenza (Seasonal) (no brand name)~1~0.00~In Patient		1						1	Facial palsy; Hypoaesthesia	FLU3~SANOFI PASTEUR~U1936AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250288	01/11/2006	CO	50.0	49		F	01/11/2006	Flu vaccine given 11/15/05. Vaccine site had mild soreness, typical following any vaccine. 3-5 days later she hit the arm with force on a door jam. Client does not recall how soon the pain began following the hit on the door jam but she began to have severe pain with left arm motion (9-10 on a scale of 10). She was unable to lift her arm above her head with her elbow bent without severe pain. Pain with that motion has continued, but the pain has decreased to a 5-6. She is awakened at night with pain when sleeping on her left side. She has taken 1 Aleve per day for the last 2 weeks. She reported initial weakness in her left fingers with slight tingling, but that has resolved. She has not seen a doctor due to financial concerns.									U	11/15/2005	11/22/2005	7	none	UNK	UNK	none	RECOVERING FROM A COLD, NO FEVER	none			1						1	Hypokinesia; Injection site pain; Paraesthesia	FLU3~SANOFI PASTEUR~U1865AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250294	01/11/2006	SC	61.0	60		F	01/11/2006	10/8/05:  Aching noted at left deltoid area. 10/10/05: Fluid-filled blisters appear on left deltoid area.  States she also had fever so she took tylenol and an antibiotic she had at home. 10/14/05:  increase in blisters.  Skin reddened and swollen down to left wrist.  Seen by MD.				Y					U	10/06/2005	10/08/2005	2	NONE	UNK	UNK	refused to give information	states none	Allergic to ASA;  Breast cancer survivior - 15 years in remission		SC0540	1						1	Blister; Erythema; Pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~V174AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~MASS. PUB HLTH BIOL LAB~Td120~1~IM~LA~TD ADSORBED (TDVAX)~1	USA	Emergency room visit	Influenza
0250295	01/11/2006	ND	55.0	54		F	01/11/2006	Patient complained of a sore throat and red, puffy eyes the  morning following the injection.  She came to our office at 1345 hours and requested Benadryl.  By the next morning the sore throat and red puffy eyes were gone, after taking the Benadryl.									N	12/06/2005	12/07/2005	1	None needed	UNK	UNK	OTC vitamins and progesterone cream	Slight sore throat for two days prior to incident	Sulfa allergy			1						1	Eye swelling; Ocular hyperaemia; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U1917AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250299	01/11/2006	NY	45.0	45		M	01/10/2006	Approx 2pm flu vaccine given approx 2:20 patient experiencing itching all over, red spots noted on face and neck.  Epinephrine  1ml given per standing order.  O2 administered.  Patient sent to ED per nurse practioner				Y					Y	12/05/2005	12/05/2005	0		OTH	OTH			Atrial Septal Aneurysm, Cromolyn, Lidocaine, dust, pollen, animal dander, baby powder, insecticide			1						1	Pruritus; Rash	FLU3~AVENTIS PASTEUR~01529PCA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250300	01/11/2006	OH	88.0	88		F	01/11/2006	I have completed this form on behalf of the patient. I am a local health department nurse. I have become familiar with the patient, over the past 6 years I have checked her blood pressure on a weekly basis. She received a flu vaccination on 10/14/05 in her right deltoid. On the evening 10/16/05, she states she began chilling and soon thereafter began vomiting. She also experienced diarrhea. She was able to tolerate small amounts of boost yet was unable to tolerate solid foods for five days. On 10/19/05, she saw her family physician with continued nausea and a heaviness in her legs. She was diagnosed with a UTI and treated with antibiotics. She gradually began tolerating solid foods yet remained weak. On 11/10/05, she experienced an episode of extreme numbness to her legs. 911 was called and she was admitted with a lab confirmed case of GBS. She was in the hospital for weeks then to be transferred to another facility. She does have some gross motor movement to her lower extremities and he arms are weak yet some fine motor skills evident. I spoke with one of the associates at the hospital in regards to reporting this case. He was not aware of this reporting system therefore I am reporting the case. Medical record states pain, confusion, CVA, urinary tract infection. Information received from the 60 day follow-up states 3-28-06 Client remains a resident. She is presently in therapy and making progress. She is now walking with the assistance of a walker and supervision. She is able to feed herself without problems. Client and her family feel that with continued therapy she may be able to leave the facility and move in with one of her children with the hope of someday getting back to her apartment.  Follow-up: 4-10-07 patient is able to ambulate with the use of a walker. She has been unable to move back to her home independently. She remains at a nursing home facility.				Y	Y		Y		N	10/14/2005	11/10/2005	27	CSF via spinal tap indicative of GBS Medical record states abnormal lab test, hypokalemia, bacterial infection. msv	PVT	PVT	Plavix 75mg QD; Isosorb 30mg BID; Diavan 1 tablet QD; Atenolol 50mg half of a tab QD; Prevacid 1 tablet QD; Bumetanide 0.5mg QD; Ecotrin 1 tablet QD; Multivitamin 1 QD; Calcium 600mg TID; Metamucil BID; Nitrostat prn		Allergies: milk, nickel, sulfa and PCN. Sensitive to the following medications Procardia, Claritin, Tagamet, Motrin, Zithromax, Vioxx, Celebrex.  Medical record states hypertension, congestive heart failure, coronary artery disease, arthritis, Gastric reflux . msv			1						1	Activities of daily living impaired; Asthenia; Bacterial infection; CSF test abnormal; Cerebrovascular accident; Confusional state; Diarrhoea; Feeling cold; Guillain-Barre syndrome; Hypoaesthesia; Hypokalaemia; Lumbar puncture; Muscular weakness; Nausea; Sensation of heaviness; Urinary tract infection; Vomiting; Walking aid user	FLU3~AVENTIS PASTEUR~U1904AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0250306	01/12/2006	FL	79.0	78		F	01/05/2006	On 12-8-05 Patient informed office that she had been having pain at injection site since 12-4-05.  Dr. diagnosed cellulitis prescribe antibiotics.  By 12-22-05 cellulitis resolved.									Y	11/30/2005	12/04/2005	4		PVT	UNK						1						1	Cellulitis; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62216~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~AVENTIS PASTEUR~U1616AA~1~~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0250307	01/12/2006	WY	53.0	52		F	12/13/2005	Approximately 5 hrs after receiving the shot patient had bad flu symptoms.  Nausea, cold chills, throwing up and aching all over.				Y					Y	11/01/2005	11/01/2005	0		PVT	PVT		NONE	Allergic Penicillin			1						1	Chills; Influenza like illness; Nausea; Pain	FLUX~UNKNOWN MANUFACTURER~AFLUA153AA~5~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0250316	01/12/2006	TX	44.0	43		M	01/12/2006	Developed transverse myelitis following administration of Flu Vaccine in 2003.  Admitted to acute care hospital Nov 2003.  Out of work for 1 month. Discharge summary states parethesia, asthenia. msv					Y	5			Y	10/10/2003	11/10/2003	31	Discharge summary states lab test abnormal. msv Medical record states hyperglycemia, abnormal csf. msv	UNK	UNK	Insulin Capoten	none.  History of IDDM,	IDDM Discharge summary states bone disease, neuropathy. msv			1						1	Asthenia; CSF test abnormal; Hyperglycaemia; Laboratory test abnormal; Myelitis transverse; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~765499~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0244630	01/13/2006	NC	6.0			F	11/16/2005	A non serious spontaneous case from physician involving hives.  The reporter causality is possible to FluMist.  A physician reported that on 21 Sep 05 a patient experienced hives approximately 12 hours after receiving FluMist vaccine.  The patient was seen at the reporter's office and was given oral hydroxyzine.  The patient had conjunctivitis at the time of vaccine and was being treated with antibiotics.  She has previous history of urticaria unrelated to vaccine administration.  Per the reporter the patient is not allergic to eggs and has received other live vaccines with no problem.  After 4 days, the patient completely recovered from the hives.  The reporter assessed the event as possibly related to FluMist vaccine.				Y					Y	09/20/2005	09/21/2005	1		PVT	OTH	NONE	Conjunctivitis	Urticaria		MEDI0003853	1						2	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500389P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Emergency room visit	Influenza
0246284	01/13/2006	NE				U	10/11/2005	A physician reported that patient received FluMist in 2004 and later in the day experienced nasal congestion and redness around the nose.  The patient completely recovered.  No other information is available. The reporter causality is not provided.									Y					PVT	OTH	Concomitant drugs not reported				MEDI0003701	1						3	Erythema; Nasal congestion; Erythema; Nasal congestion	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3	USA		Influenza
0250332	01/13/2006	VA	20.0	20		M	01/13/2006	The Department of Health informed the HC in May 05 of the death of a medically discharged patient. The patient enlisted in Nov 04, medically discharged in Jan 05, and died on Feb 17th. The following HPI is an account of the events prior to his death as recalled by his mother during an interview in May 05. The service member a 20 year old male, who received his enlistment vaccines on 23 Nov 04. While speaking with his mom on 30 Nov he mentioned that he had a cough, and some chest pain. She state that she encourage him to seek medical attention. She state that a couple of days later, while he was running he 'passed out' and when he went to the doctor he was told it was asthma. Mom reported that while he was at home during Christmas, he reported to his family that he was experiencing some chest pain, and did have bumps on his face that cleared in Jan. Mom was unaware of which vaccines her son received but did remember that her son said that the needle was funny. Mom does not recall if he had a scar on his arm. She state that he was discharged for stress related issues and complaints of chest pain. Mom is unaware of any other details regarding her son's illness during that time only that the chest pain persisted. When questioned about his past history of asthma, she mentioned that he had it a little in childhood but has not been bothered by it since that time. She did mention that her son felt that his pain was not related to asthma. Mom was also questioned about the waiver for a medical exam upon discharge. She state that he was told that if he requested a workup, it would delay his release and that they may not even discharge him. He received his enlistment vaccines of Hep A-Hep B, Influenza, Meningococcal, MRR, Polio, and Td on 23 Nov 04 and he received his second Hep A-Hep B on 5 Jan 05. Chest pain start 11/30/2004, dyspnea (shortness of breath) start 11/30/2004. 4/3/06 Received Autopsy Report which revealed COD as chronic myocarditis.	Y	02/17/2005							N	11/23/2004	11/30/2004	7	18 Feb 05: Cardiac-normal distribution of small patent coronary arteries. The valves appear normal. The myocardium does not show any acute changes. The left ventricle measures 1.4 cm in thickness. The septum measures 1.4 cm in thickness. The aorta has youthful intima. Resp-prominent congestion and mild edema without any discrete lesion. The airways patent. The vasculature free of thromboemboli. Microscopic Exam: Heart the mural sections show rare perivascular mononuclear cells some with plasmacytoid features. The AV node section shows extensive infiltration with mononuclear cells many of which are necrotic. Lung there is edema and congestion with focal mild interstitial chronic inflammation and proliferation of pigmented alveolar macrophages. Brain and live - unremarkable. Kidney a rare Bowman capsule sclerosis is seen in the cortex. Pathologic diagnosis: Chronic myocarditis involving AV node. No lethal injuries.	MIL	MIL			Asthma age 5			1						1	Asthma; Chest pain; Cough; Loss of consciousness; Myocarditis; Nasal congestion; Oedema	FLU3~SANOFI PASTEUR~U1501AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~UNKNOWN MANUFACTURER~AHABA015AA~2~UN~UN~HEP A (NO BRAND NAME)~1|IPV~SANOFI PASTEUR~X0706~1~SC~UN~POLIO VIRUS, INACT. (IPOL)~1|MEN~UNKNOWN MANUFACTURER~UE122AA~1~SC~UN~MENINGOCOCCAL (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0781P~1~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|TD~SANOFI PASTEUR~01282AA~1~IM~UN~TD ADSORBED (NO BRAND NAME)~1	USA	Results in Death	Influenza
0250341	01/13/2006	NC	74.0	74		M	01/10/2006	Numbness and weakness in legs progressed to arms, face about 1 week before presenting to physician 12/27/05. Tx: IVIG. Diagnosed GBS. Discharge summary states decreased reflexes, hypertension, chest pain, gout. msv Annual follow up information indicates patient has not recovered, since injection patient has had electric shock type feelings throughtout his body. Admitted to hospital 5/30/06 with right side weakness & numbness. MRI showed moderate cerebral atrophy with associated periventricule ischemic demyelinization. Admission to hosptial 12-27-05 with extremity numbness & weakness. Per 60 day follow up: GUILLAIN BARRE has resolved except for occassional parethesias.					Y	10			Y	12/09/2005	12/20/2005	11	Discharge summary states lab tests abnormal, csf abnormal. msv	PVT	PVT	ASA; Nexium; Pulmicort; Singulair; Milk thistle		Asthma; GERD; S/P knee replacement Discharge summary states hyperlipidemia, bone disorder.  Medical records state brain aneurysm. msv			1						1	Blood product transfusion; CSF test abnormal; Chest pain; Gout; Guillain-Barre syndrome; Hypertension; Hypoaesthesia; Hyporeflexia; Laboratory test abnormal; Muscular weakness; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~63356~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0747P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0250344	01/13/2006	NY	1.08	1	.1	M	01/05/2006	3-4 day hours of fever followed by outbreak of diffuse rash, erythematous papular rash.  Rosacea vs post vaccine measles/rubella reaction.										12/22/2005	01/01/2006	10		OTH	PUB			NONE			1						1	Pyrexia; Rash erythematous; Rosacea	FLU3~SANOFI PASTEUR~U1787BA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0442R~3~~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0295R~UNK~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0121BR~UNK~~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0250345	01/13/2006	LA	56.0	55		M	12/31/2005	11/07/2005 Seen in ER and patient stated he had stiffness in left arm on Saturday 11/05/2005 and broke out today, 11/07/2005 with blisters where injection was given.  11/09/2005 no other problems noted.  Small 3mm blister noted on left deltoid.									Y	11/04/2005			NONE	PVT	PVT		NONE	Allergic to PPD skin test			1						1	Hypokinesia; Injection site vesicles	FLU3~SANOFI PASTEUR~U1866AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250346	01/13/2006	TX	34.0	33		F	01/06/2006	On 01/04/2006 received flu vaccine in left deltoid.  Shortly thereafter developed swelling, induration, pain and erythema around injection site which has progressively worsened.  Area involved is size of ping-pong ball.										01/04/2006	01/04/2006	0		PVT	UNK	OCA	NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~63194~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0250347	01/13/2006	PA	65.0	64		F	01/10/2006	Fluzone vaccine administered by accident.  Patient had local reaction at age 19.  She has never had the flu vaccine since.  Patient reacted with redness and itchiness.									U	01/10/2006	01/10/2006	0		PVT	PVT		Arthritis flare	NIDDM, HTN, GERD, CVA, Asthma, Allergies, Diverticulosis, Gastric bypass.	large local reaction~Influenza (Seasonal) (no brand name)~~19.00~In Patient		1						1	Medication error	FLU3~SANOFI PASTEUR~4938AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0791P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0250348	01/13/2006	NY	3.0	3		F	01/09/2006	Approximately 5 hours after receiving flu vaccine mother noticed a rash on face extending to legs and back.  Also lip itchiness.									Y	01/05/2006	01/05/2006	0		MIL	UNK		Viral syndrome, abnormal ua				1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U1788HA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250349	01/13/2006	NY	4.0	4		M	12/28/2005	Left arm soft tissue, swelling and redness, tenderness measured 14.5cm x 11cm.  Left arm Cellulitis.				Y					Y	12/14/2005	12/15/2005	1	NONE	PVT	PUB		NONE	Amoxicillin - hives			1						1	Cellulitis; Erythema; Swelling; Tenderness	DTAP~GLAXOSMITHKLINE BIOLOGICALS~C2243AA~5~~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1819AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0324~4~~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0935P~2~~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0250350	01/13/2006	IN	1.4	1	.4	F	01/05/2006	Small knot at injection site.  No redness, swelling noted by mother.  Possibility it is from the HIB injection.  Child gets very tense at time of immunizations.									Y	12/15/2005			NONE	PUB	PUB		NONE	NONE			1						1	Injection site mass	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~21A004AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1765EA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0528R~3~IM~RL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0301R~UNK~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0637R~UNK~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0250355	01/13/2006	OH	1.04	1	.0	M	01/12/2006	Rash all over body - started on face and spread down chest and back and to extremities and low grade fever.  Symptomatic treatment for fever and cough.				Y					U	12/30/2005	01/04/2006	5	NONE	PVT	OTH	Flovent, Albuterol	NONE	Asthma			1						1	Cough; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U1765DA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0694R~3~~RL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0377R~UNK~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A56077A~4~~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0120R~UNK~~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0250368	01/13/2006	WI	13.0	12		M	12/22/2005	Immunization given at 8am. School contacted parent. Patient was complaining of dizziness, had difficulty walking, fever of 101.  Slept at home until this AM.  12/22 Seen by provider.  Temp 103 given Tylenol at clinic.  Wheezing (history of asthma) weakness and difficulty walking.  Treatment-Tylenol, Rule out viral infection.  Local injection site sore/red.										12/21/2005	12/21/2005	0	(per parent) quick strep	PUB	UNK	Asthma, Advira, Singular, Loratadine,Prn Albuterol	NONE	Asthma			1						1	Asthenia; Difficulty in walking; Dizziness; Injection site hypersensitivity; Injection site pain; Pyrexia; Somnolence; Wheezing	FLU3~SANOFI PASTEUR~41761AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250373	01/13/2006	PA	1.28	1	.3	F	12/27/2005	6-8 chicken pox bumps on buttocks and thighs.									U	12/15/2005	12/27/2005	12	NONE	OTH	PUB	NONE	NONE	NKDA			1						1	Viral infection	DTAP~SANOFI PASTEUR~U1397BA~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1914AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE709AA~3~IM~RL~HIB (PROHIBIT)~1|MMR~MERCK & CO. INC.~0465R~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A98340K~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0789R~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0250388	01/13/2006	ND	1.23	1	.2	F	01/13/2006	On 12/29/05 child was irritable, felt warm, had a poor appetite and had red spots on her with no fluid on her head, diaper area and back. Ended up being worst on Sunday, 1/1/06 with big hard fluid filled red spots that popped open and scabbed over per mother.  Mother states treated with baths and Tylenol and child recovered.  On 1/13/06 mother called to say that 2 brothers previousily immunized for varicella were also sent home from school with chickenpox.									Y	12/21/2005			None	UNK	UNK	None	None - child was healthy	None			1						1	Decreased appetite; Feeling hot; Irritability	FLU3~SANOFI PASTEUR~U1787CA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0611D~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0216R~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0250389	01/13/2006	VA	1.0	1	.0	M	01/13/2006	Red area at right thigh, then 2 papules formed, which almost vesiculated and are now drying up.  These vesicles were at the sight of the varicella injection.  Clinically the child is fine.									U	12/22/2005	01/05/2006	14	none	UNK	UNK	NONE KNOWN	NONE KNOWN	NONE KNOWN			1						1	Erythema; Injection site vesicles	FLU3~SANOFI PASTEUR~U1787DA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0377R~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0635R~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0250395	01/13/2006	MI	35.0	35		F	01/13/2006	Patient received pneumococcal vaccine, lot# 0877R, right deltoid in clinic 12/20/05. Called office 12/22/05 to report right deltoid pain, itching, redness, swelling at injection site, et syncope on 12/20/05. Advised to go to ER. 12/23/05 notified patient at ER with fever 103, severe body myalgias, HA, suspects meningitis. Work up for meningitis was negative. WBC 20,000. Patient was discharged 12/27/05.				Y	Y	5			Y	12/20/2005			Need to contact ER.	UNK	UNK	Elidel PRN, Klonopin 0.5 mg PRN anxiety, Lexapro 20 mg daily.		No known allergies. Congenital Heart Disease - ASD.			1						1	Headache; Injection site erythema; Injection site hypersensitivity; Injection site pain; Injection site swelling; Myalgia; Pruritus; Pyrexia; Syncope; White blood cell count increased	FLU3~SANOFI PASTEUR~U1903AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0877R~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0250396	01/13/2006	MI	40.0	39		F	01/13/2006	Patient received Pneumococcal Pneumovax vaccine IM right deltoid lot #0605R. Called 12/22/05 to report right arm swelling, heat, itching, underarm pain. Advised patient to take allegra and ibuprofen. 12/23/05 called patient. Patient doing better, pain gone, swelling improved.									Y	12/20/2005			None	UNK	UNK	Paxil 20 mg PO Daily, Albuterol inhalation daily, Allegra D PO Daily PRN, Xanax PRN, Tenormin 25 mg PO BID		No known allergies. Congenital Heart Disease.S/P coarctation repair.			1						1	Feeling hot; Pain; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U1903AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0605R~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0250416	01/13/2006	MN				M		A patient experienced upper respiratory infection after receiving FluMist in 17 Nov 2005.  The upper respiratory infection has persisted for about six days at the time of report.  Further information has been requested.  The clinical outcome is unknown.  The reporter causality is not provided.									U	11/17/2005	11/18/2005	1		PUB	PUB	Concomitant drugs not reported				MEDI0003879	1						1	Upper respiratory tract infection	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0250418	01/13/2006	CA	12.0			M	10/28/2005	A consumer reported that her child experienced vomiting, severe headache, stuffy nose and watering eyes 2 days after receiving FluMist vaccine on 25 Oct 2005.  In school, vomited four times.  Motrin and Dimetapp were given orally.  By 29 Oct 2005, the patient had recovered from all symptoms except for the stuffy nose.  The reporter added that the other child received FluMist but did not have any adverse reaction.  The reporter assessed the events as possibly related to FluMist.									N	10/25/2005	10/27/2005	2		PVT	PVT	Concomitant drugs not reported				MEDI0003781	1						1	Headache; Lacrimation increased; Nasal congestion; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0250419	01/13/2006	NC	5.0	5		F	11/07/2005	A nurse from a doctor's office reported that patient with no past medical history experienced fever of 103 degrees Fahrenheit, coughing and body aches 3 days after receiving FluMist vaccine on 04 Nov 2005.  The patient was seen at doctor's office and was given Tylenol and albuterol. On 08 Nov 05, the patient's mother called the doctor's office to report that the patient was still coughing, had body aches and low grade fever of 100 degrees Fahrenheit. The reporter causality is not provided. Additional information has been requested.									U	11/04/2005	11/07/2005	3	Body temp-11/07/05 103 degrees; 11/08/05 100 degrees	PVT	OTH	Concomitant Drug(s) not reported				MEDI0003814	1						1	Cough; Pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500386P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0250420	01/13/2006	PA	37.0			M	11/28/2005	A patient received FluMist vaccination on 28 Nov 2005 for influenza immunization.  Within 1-2 hours of receiving FluMist patient experienced dizziness and headache.  When the symptoms occurred patient called facility where they received the vaccination however was not given any specific instructions. No additional information was available at the time of this report.									U	11/28/2005	11/28/2005	0		PVT	PVT	Concomitant drug(s) not reported				MEDI0003888	1						1	Dizziness; Headache	FLUN3~MEDIMMUNE VACCINES, INC.~5000394P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0250421	01/13/2006	TX				F	11/30/2005	Felt ill (malaise).  Vaccine exposure during pregnancy.  Non serious spontaneous case from a Pharmacist involving a woman who felt ill.  The reporter causality is possible to FluMist. A woman received FluMist vaccination intra-nasally for influenza immunization on 12 Nov 2005.  The woman was 31 weeks pregnant at time of vaccination. On an unspecified date she felt ill. It was not reported whether or not the symptoms continued.									U	11/12/2005				OTH	OTH	Concomitant drugs not reported				MEDI0003897	1						1	Malaise; Unintended pregnancy	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0250423	01/13/2006	PA	8.0	7		F	01/13/2006	Generalized rash-fine, small reddened papules with itching.  Child awoke this AM with the rash and complained of itching. Gave Benadryl phone order 2 tsp. Had vaccine 13 hrs prior; had also just completed a second course of Zithromax on the same day.									Y	01/12/2006	01/13/2006	1		OTH	OTH	Just completed Zithromax on 1/12/06.	NONE recently recovered from strep throat	Penicillin, Sulfa, Cefzil allergies, Grade II Vesico-uretical reflux			1						1	Erythema; Pruritus; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~63423~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0250424	01/13/2006	WA	29.0	29		F	01/13/2006	Immediate pain after injection , fever that night.  Pain in left shoulder still decreased range of motion, severe pain in the front of shoulder.  Seen in ER the by an ortho specialist. Given two cortisone injections (October and December) and still unable to bring arm across chest and nonstop pain.  Had an MRI in Dec 2005, showed				Y					N	10/10/2005	10/10/2005	0	MRI done and PT ordered, not started yet.	PVT	PUB	NONE	NONE	NONE			1						1	Joint range of motion decreased; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~AFLUA122BB~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0250425	01/13/2006	IN	30.0	30		F	01/13/2006	Site and arm pain - redness, swelling, red pin point at site.									Y	11/06/2005	11/06/2005	0	NONE	OTH	MIL	Unknown	NONE	NONE			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U1911AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250406	01/16/2006	GA	38.0	37		F	01/16/2006	Red, splotchy rash appeared on legs and progressed to forearms. Itchy at first then it subsided. Led to full body coverage of red rash. Spots and rash was not inflammed only erythematous. Patient saw primary care provider 6-7 days after rash appeared and was given a Medrol dose pack. Blood work was obtained and all came back within normal limits. Another round of prednisone was given as well as Kenalog. Improvement has been slow. Recovery is still in process.				Y					Y	11/10/2005	11/14/2005	4	Dermatologist diagnosis of vasculitis, complete lab work-up.	UNK	UNK	Depo-Provera injection	None	NKDA			1						1	Erythema; Rash; Rash maculo-papular; Vasculitis	FLU3~SANOFI PASTEUR~U1762AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250422	01/17/2006	NC	1.04	1	.0	M	01/13/2006	Rash maculopapular on 01/05/2006, no fever, mild fussiness.									Y	12/23/2005	01/04/2006	12		PVT	UNK	Pulmacort, Albuterol	Asthma	No know drug allergy, Asthma/RAD History of respiratory synctial virus			1						1	Irritability; Rash maculo-papular	FLU3~SANOFI PASTEUR~64831AB~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0609P~UNK~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0071R~UNK~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0250433	01/17/2006	WV	61.0	61		F	01/11/2006	The first week of April 2005, she was diagnosed with Guillain Barre Syndrome. She was totally paralyzed and on respiratory assistance. She is now in a rehab hospital. She is much better now 1/06, but still in rehab and speech therapy.  Discharge summary of 4/9-5/23/05. FINAL DX: Guillain-Barre syndrome; respiratory failure; GI bleed. Records reveal patient experienced weakness of left eye & left extremities which rapidly progressed to include all extremities.  Neuro consult done.  Tx w/IVIG.  Developed respiratory failure due to progressive muscular weakness & intubated; SVT resolved; hypotension, resolved w/fluids & blood transfusion; emergent laparoscopy for GI bleeding secondary to gastric artery lacerations; DVT in RUE s/p PICC line insertion; constipation; hypomagnesium; Trached w/collar O2, tube feeding & nonambulatory upon d/c to inpatient rehab facility.			Y	Y	Y	45	Y		N	12/08/2004	04/05/2005	118	Guillain Barre Syndrome  Medical records LABS: EMG/NCS abnormal & c/w GBS.	PUB	PUB		NONE	Discharge summary states PMH: spinal stenosis, chronic renal insuffencey, hypothyroidism, multinodular goiter, GERD, hypertension, asthma.			1						1	Gastrointestinal haemorrhage; Guillain-Barre syndrome; Laboratory test abnormal; Paralysis	FLU3~SANOFI PASTEUR~U1455CA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0250434	01/17/2006	ND	82.0	82		M	11/10/2005	Anaphylaxis to flu shot. Dyspnea, audible crackles, diaphoretic, nausea, skin cool to touch, nausea, accessory muscles to breath.			Y		Y	3			Y	11/07/2005	11/08/2005	1		PVT	PVT	ASA; Prilosec; KCl; Plavix; Crestor; Lopressor; Lasix;		Anemia; CRF; Bladder outlet obstruction; Gynecomastia; Recent chest pain; Recent bradycardia			1						1	Anaphylactic reaction; Dyspnoea; Feeling cold; Hyperhidrosis; Nausea	FLU3~SANOFI PASTEUR~U1761AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0250435	01/17/2006	CA	1.01	1	.0	M	01/10/2006	Two days after vaccination patient has a 30-40 min episode of upper and lower extremities rhythmic jerking movements without LOC; No fever;recovered with IV valium.				Y	Y	2			Y	01/04/2006	01/06/2006	2		PVT	PVT						1						1	Dyskinesia	FLU3~SANOFI PASTEUR~U1787EA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0485R~1~~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~07619~1~~RL~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0250436	01/17/2006	MI	3.0	2	.7	M	01/04/2006	5-10 minutes status post vaccines, developed respiratory distress, apnea; given O2. Saturation initially 70% increasing to high 80s with O2. EMS activated. Taken via EMS to ER. Received 5Q Epi and corticosteroids. Observed as inpatient. Discharged next morning.  2/7/06 Discharge Summary reviewed stated patient experienced premature birth w/cleft lip & palate (s/p repair), glaucoma, developmental delay (decreased speech), cyanosis, apnea, urticaria, wheezing, uvular & facial swelling, hypoxia.  Final dx: acute anaphylactic reaction, life threatening event, possible egg allergy.				Y	Y				Y	01/03/2006	01/03/2006	0		PVT	PVT	NONE		Cleft palate; Prematurity; Developmental delay; cataracts.			1						1	Anaphylactic reaction; Apnoea; Cleft lip and palate; Cyanosis; Face oedema; Glaucoma; Hypersensitivity; Hypoxia; Laryngeal oedema; Premature baby; Respiratory distress; Speech disorder; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U1787DA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB077CA~1~IM~LL~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~0791R~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0250437	01/17/2006	PA	59.0	58		U		Received fluzone vaccine in AM and had 4 hour episode of internal chills and feeling incapacitated.  Denies diaphoresis during episode.  Felt chilled to my core.									Y	01/06/2006	01/06/2006	0	NONE	OTH	PVT	Lisinopril, Lipitor, Synthroid		Hypothyroidism, HTN, increased blood lipid levels.			1						1	Chills; Feeling abnormal	FLU3~SANOFI PASTEUR~U1938AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250438	01/17/2006	NY	47.0	46		F	01/09/2006	Patient reported had flu shot 1 month ago December 7th.  Since that date has experienced pain, arm and finger, numbness, and lost range of motion in right arm.  X-rays done by doctor - no arthritis, no bone or shoulder injury.  Currently using heat, Tylenol and Advil.  To start physical therapy on Thursday, 01/12/2006.				Y						12/07/2005	12/10/2005	3	X-rays of right arm - no bone or shoulder injury or arthritic changes.	PUB	PUB	NONE	NONE	NONE			1						1	Hypoaesthesia; Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~U1916AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250439	01/17/2006	NC	26.0	26		M	01/05/2006	Erythema, edema, heat at site of immunization.  Edema has increased since date of injection, right arm deltoid.  Approximately 50mm diameter of circular swelling around injection site.									Y	10/20/2005	10/20/2005	0	NONE	PUB	PUB	Norvasc Lisinopril HCTZ	NONE	NONE		NC06002	1						1	Erythema; Injection site swelling; Injection site warmth; Oedema	FLU3~SANOFI PASTEUR~U1836AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250440	01/17/2006	OH	0.56	0	.6	M	01/13/2006	Onset 4am, 12/13/2005 - Generalized erythema, jerking head back and forth, shaking arms/legs, increased heart rate, fever 104.3-102.6  Possible febrile seizure.  Prescribed Tylenol, Motrin, Oral fluids.				Y					Y	12/12/2005	12/13/2005	1	NONE	PVT	PUB	Prevacid	GERD	GERD Medical records state vomiting. msv			1						1	Dyskinesia; Erythema; Heart rate increased; Pyrexia; Tremor	DTAP~SANOFI PASTEUR~U1396DA~3~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1765DA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0297R~2~IM~LL~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~A56077A~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0250461	01/17/2006	KY	27.0	26		F	12/09/2005	Started with mild pain at 5pm on 11-29-05, achy joint of shoulder.  At 2-3 am 11/30 severe pain, horrible, could not lie on lt side, could not elevate arm, now 12/12 remains tender, unable to raise arm easily to reach into cupboard, cannot sleep on lt side deltoid arm very tender.									Y	11/29/2005	11/29/2005	0		UNK	UNK	prenatal vitamins	n/a	5 months pregnant		KY2006005	1						1	Arthralgia; Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U1858BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250465	01/17/2006	MN	43.0	42		F	01/17/2006	Developed severe myalgias in right deltoid, right shoulder, right thoracic back, and radiated to left thoracic back.  Painful to do tasks at work like typing and note taking.  (Pt is right handed.)  No paresthesias.  History of similar myalgias occurring after administration of flu shot,  lasting for 3 months.  No erthyema or swellling of site.  No relief of symptoms with pain medication (tylenol).  Very sensitive to medications, did not want to take muscle relaxers or ibuprofen.  Recommended to pt to try moist heat and biofreeze topical lotion.									U	01/12/2006	01/13/2006	1		UNK	UNK	Levothroid	none	no	severe myalgia~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Hypersensitivity; Myalgia; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA141BA~3~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0250468	01/17/2006	FL	42.0	42		M	01/17/2006	Tingling and numbness in both hands and both feet, weak muscles in upper back, lower back, legs and arms poor bladder and bowel control, limited numbness in legs and lower torso up to but not including the chest  TREATMENT 5 days of IV of immunogobulins each day 30ml except for days 4 which was 24ml and day 5 which was 26ml because enough was not found. Information from Medical records includes back pain as symptoms. msv  Discharge summary states reflexes decreased, ataxia, GBS, weak. msv 3/31/2010 Follow up: Sensory loss in legs and feet along with recurrent pain in hand and forearms developing arthritis in joints.			Y	Y	Y	7	Y		N	11/29/2005	12/12/2005	13	Blood chemistry, lower lumbar puncture, MRI of spinal cord and neck, xrays of head, neck, chest, spine, CAT scan of brain.  Information from Medical records states abnormal EMG, abnormal CSF, Creatinine elevated. msv Discharge summary states CSF protein increases, transaminase elevated, lab tests abnormal. Information received from the 60 day follow-up states the recovery process is still taking place but my conditions is getting better. Still numbness in feet, pain in hands and arms, fatigue, and difficulty with balance. GBS recovery takes 6 months - 2 years.	UNK	UNK		Upper respiratory infection, post nasal drip.	No known allergies to drugs or food, upper respiratory infection, post nasal drip. Medical records includes hyperlipidemia as Hx. msv			1						1	Arthritis; Back pain; Balance disorder; Blood creatinine increased; Blood test; CSF protein abnormal; CSF test abnormal; Chest X-ray; Coordination abnormal; Electromyogram abnormal; Faecal incontinence; Fatigue; Guillain-Barre syndrome; Hypoaesthesia; Hyporeflexia; Immunoglobulin therapy; Laboratory test abnormal; Lumbar puncture; Muscular weakness; Muscular weakness; Nuclear magnetic resonance imaging; Pain in extremity; Paraesthesia; Scan brain; Sensory loss; Skull X-ray; Spinal X-ray; Transaminases increased; Urinary incontinence; X-ray	FLU3~SANOFI PASTEUR~U1854AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0250476	01/17/2006	TX	36.0	35		F	01/17/2006	Patient received AVA #1 on 17 Dec 03 noticed an intense burn for 5 min that radiated down hand immediately following the vaccination.  Noticed slight redness and swelling at the injection site.  Mid Jan 04 noticed stiffness and soreness of hips, knees and shoulders that would require taking 10 steps just to straighten up from a sitting position.  Initially thought it was due to deployment and poor quality beds.  Patient reported problems keeping up with people walking at a normal gain, nothing drastic, just trailing 10-15 steps behind others in her unit.  Noticed that stiffness was worse in the morning and after periods of inactivity.  Stated began feeling like the day after completing a road march and whole body was fatigued.  Noted some days were better than others, muscles felt sore, but joints bothered more.  Initially hips were most bothersome.  Pain described as a deep pain, #4 scale 1-10 with 10 being worse, with varying degrees of intensity but always present.  Tylenol and physical therapy would help a little but noticed no relief with ibuprofen.  Did initially have problems with foot pain but that is not as bothersome now, however no longer walking as did in the past.  Reports occasional stiffness of hands and mild muscle discomfort.  Describes this discomfort as a fatigue more so than a ache.  Notices that always tired, and unable to attribute this fatigue with activity.  Noticed that there is an increase in the aching when it is cold.  Has had rheumatologic evaluation and to date no diagnosis has been determined.				Y						12/17/2003	01/17/2004	31	27 Jan 05: Whole body bone scan-the delayed whoe body planar images show mild focal increased uptake in the bilateral acriomio-clavicular joints bilateral hip joints and left patella suggestive of mild degenerative changes.  There is asymmetric mild focal uptake at the rt lesser trochanteric region suggestive of stress related changes.  There is focal uptake at the rt 1st MTP joint region medially at the sesamoid bone suggestive or sesamoiditis.  There is also focal uptake at the left 1st MTP joint suggestive of stress related/post traumatic/degenerative changes.  Impression: Mild DJD of the shoulder joints, hip joints and knee joints as described above.  Sesamoiditis of rt foot.  Mild stress related changes as described above.	MIL	MIL	Naprosyn 500 mg, Acetaminophen 500mg	NONE	Iliotibial band syndrome			1						1	Arthralgia; Erythema; Fatigue; Joint stiffness; Muscle atrophy; Musculoskeletal discomfort; Myalgia; Pain; Swelling	ANTH~MICHIGAN DEPT PUB HLTH~FAV081~1~SC~~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~U1269AA~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0250224	01/18/2006	TX	45.0	44		M	01/16/2006	Initial report received on 01/10/2006 from a health care professional. A 44 year old male with no significant medical history had received his first administration (route not reported) of Fluzone SV 2005 2006 USP, lot number U1866AA, in the right deltoid, on the afternoon of 12/02/2005. At an unspecified time later, he developed swelling to both of his hands and at the injection site. On 12/07/2005 the patient was seen in the physicians office with local swelling to the right deltoid and he was diagnosed with mild myalgia. On 12/09/2005 he returned to the physicians office and all of his symptoms had improved to where he only had aching in his left hand. The patient stated that he was much better and the physicians exam that day was negative. On 01/09/2006 the patient returned to the physicians office with a complaint of cough, shortness of breath and swelling of the lower extremities. He was referred to the ER and left AMA. On 01/10/2006 the patient was again seen in the physicians office with increased SOB, dizziness, 3+ tibial edema, increased jugular vein distention, irregular heart beat and weight increase to 238 lbs. The patient was sent to the hospital via ambulance. Per the reporter, it is unknown if the patient recovered from these events at the time of this report.				Y					N	12/02/2005	12/02/2005	0		OTH	PVT					200600080	1						2	Cough; Dizziness; Dyspnoea; Heart rate irregular; Injection site oedema; Myalgia; Oedema; Oedema peripheral; Pain; Vasodilatation; Weight increased; Cough; Dizziness; Dyspnoea; Heart rate irregular; Injection site oedema; Myalgia; Oedema; Oedema peripheral; Pain; Vasodilatation; Weight increased	FLU3~SANOFI PASTEUR~U1866AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1866AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0250489	01/18/2006	CA	47.0	47		F		On 12/23 patient developed fever up to 104 at home. Presents to hosp ER and noted document that left arm demonstrates an area of erythema about the size of a silver dollar, tender to touch and indurated. Fever continued per patients about 12 days. Admitted on 12/31 for evaluation meningitis. Follow-up: Red swollen.					Y				Y	12/22/2005	12/23/2005	1	CSF;WBC's at 31;80 degrees lymphs;Protein 75;some elevation in liver function tests.	PVT	PVT			Hx of Pneumonia			1						1	CSF lymphocyte count increased; CSF protein increased; CSF white blood cell count increased; Erythema; Induration; Liver function test abnormal; Pyrexia; Swelling; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62014~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1006P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0250504	01/18/2006	VA	1.02	1	.0	M		Child reportedly fussy, irritable and with mild fever during interval between vaccines and death. 2/27/06 Received autopsy report which reveals patient's COD was Sudden Unexpected Death in Childhood/ss No new information found in medical records from PCP.	Y	10/30/2005							N	10/25/2005	10/30/2005	5		PVT	OTH						1						1	Irritability; Pyrexia; Sudden infant death syndrome; Unevaluable event	FLU3~SANOFI PASTEUR~U1762AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0935P~UNK~~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0195P~UNK~~RL~VARICELLA (VARIVAX)~1|FLU3~SANOFI PASTEUR~U1762AA~1~SC~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|MMR~MERCK & CO. INC.~0935P~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~2|VARCEL~MERCK & CO. INC.~0195P~1~SC~RL~VARICELLA (VARIVAX)~2	USA	Results in Death	Influenza
0250505	01/18/2006	MN	41.0	41		M	01/09/2006	Seven hours after patient received shot there stomach became painful, then got chills with nausea.  24 hours later sinuses were draining and spirting out a lot of slime.  36 hours later patient was spitting yellow slime.  Patient started taking antibiotics available at home. Patient sick for 3 weeks									Y	11/17/2005	11/17/2005	0		PVT	PVT		NONE	NONE			1						1	Abdominal pain; Chills; Nausea; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1913AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250506	01/18/2006	AZ	87.0	86		F	01/12/2006	Received injection R deltoid 11/7/05.  Beginning 11/8/05 has had pain on/off in R arm/shoulder since through today.  Did not experience erythema/swelling in shoulder.  Symptoms similar to rotator cuff tendinitis vs tear.				Y					U	11/07/2005	11/08/2005	1	MRI shoulder is ordered.	OTH	OTH	Tamoxifen, Dyazide, Synthroid, Diltiazem	NONE	Hypertension, Breast cancer, Hypothyroid, restless legs			1						1	Pain; Rotator cuff syndrome; Shoulder pain; Tendonitis	FLUX~UNKNOWN MANUFACTURER~U1816AA~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~1046P~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0250507	01/18/2006	TX	3.0	2	.5	F	01/13/2006	Arm and leg on side of vaccination became so painful unable to put on clothes. After 24 hrs then resolved spontaneously.									Y	11/19/2005	11/20/2005	1		PVT	PVT						1						1	Pain	FLU3~SANOFI PASTEUR~U17431CA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250508	01/18/2006	FL	50.0	50		M	01/04/2006	Itching, red, hive like rash on neck approx 90 minutes after injection, insidious onset									Y	01/04/2006	01/04/2006	0		MIL	MIL	NONE	NONE	Seasonal allergies-ragweed			1						1	Erythema; Pruritus; Rash	FLU3~SANOFI PASTEUR~U1936AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250509	01/18/2006	OR	36.0	35		F		Within 1/2 hour arm became painful and swollen at site.  The swelling continued and spread from shoulder to elbow over the next 24-48 hours.  Patient contacted an on-call physician and was prescribed Omnicef with 3 doses.  About 18 hours the swelling almost totally resolved still had muscle tenderness.  No fever.										01/06/2006	01/06/2006	0		PVT	PVT	Celexa 40mg	URI	No allergies or birth defects.  Anorexia nervosa			1						1	Myalgia; Pain; Swelling	FLU3~SANOFI PASTEUR~U183~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0605R~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0250510	01/18/2006	NV	53.0	53		F	01/04/2006	Achy arm/shoulder-continuing to get worse-range of motion not good-hurts to remove clothes overhead.  Sideways movement at times sharp pain.  Exam area of L upperarm site is tender and warm to touch.										11/16/2005	11/23/2005	7		OTH	UNK	NONE	NONE	NONE			1						1	Feeling hot; Joint range of motion decreased; Pain; Tenderness	FLU3~SANOFI PASTEUR~U1794AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250511	01/18/2006	MO	0.5	0	.5	F	12/30/2005	Bullous at site of DTAP.  All 4 injection sites red, warm, 3-5cm size.  Diffuse macular skin eruption.									Y	12/19/2005				PVT	PVT		NONE	NONE			1						1	Dermatitis bullous; Erythema; Feeling hot; Rash macular	DTAP~GLAXOSMITHKLINE BIOLOGICALS~A1143008AA~3~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1743MA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X0460~3~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~B08643B~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0250512	01/18/2006	SC	6.0	6		F	01/11/2006	Mother relates nausea with onset 4hr or less after administration of vaccine, followed by abdominal pain, vomiting, diarrhea, this also occurred after 1st dose on 11/30/2005.				Y					Y	01/03/2006	01/03/2006	0		PVT	PUB			Sulfa drug allergy			1						1	Abdominal pain; Diarrhoea; Nausea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~800387P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0250513	01/18/2006	CA	60.0	59		F	01/11/2006	Patient presents 1/11/06 with L arm swollen, red, hard, warm in large area distal to vaccination sites.  No streaking, margins of induration uneven.  Denies itching, reports fever.  Prescribed Keflex, Motrin and Benadryl.				Y						01/10/2006	01/10/2006	0		PVT	PUB	Prilosec, Naprosyn, Tylenol #3, Glipizide	Abdomen tenderness	Adult onset diabetes mellitus, Osteoarthritis			1						1	Erythema; Feeling hot; Injection site induration; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U1914AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1049P~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0250515	01/18/2006	IL	54.0	54		M	12/07/2005	At 2pm patient experienced watery itchy eyes, runny nose and chop cough.  Resolved with over the counter antihistamine and symptoms were gone next morning.									Y	12/06/2005	12/06/2005	0		OTH	OTH	NONE	NONE	NONE			1						1	Cough; Eye irritation; Lacrimation increased	FLU3~SANOFI PASTEUR~U1854AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250516	01/18/2006	PA	5.0	5		M	01/10/2006	L deltoid area at site where flu vaccine was given, red and swollen 10x5 cm area-tender and firm.  Similar reaction to flu vaccine last year.  Treated with Benadryl, Orapred				Y					Y	11/15/2005	11/16/2005	1		PVT	PVT		NONE	NONE			1						1	Erythema; Injection site induration; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U1910AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250519	01/18/2006	OH	48.0	48		F	01/18/2006	Received shot at approx. 10 a.m. on 1/10/06.  Began to feel achy around 3:00pm.  That evening experience muscle and joint pain, headache, heart racing, heart palpitations and dizziness.  Went into work next day still felt ill and called doctor.  Doctor wanted to see immediately. (1/11/06) Physician believes all are side effects of flu shot.  Returned to Doctor on 1/12/06 because still experiencing heart racing, dizziness and palpitations.  Dr. orders heart monitor for 24 hours.  Do not have the results as of yet.  I now have a sinus infection and bronchitis (1/16/06-present).				Y					Y	01/10/2006	01/10/2006	0	Heart monitor worn.	UNK	UNK	None	none	none.			1						1	Arthralgia; Bronchitis; Dizziness; Headache; Heart rate increased; Myalgia; Pain; Palpitations; Sinusitis	FLU3~PFIZER\WYETH~~2~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0250521	01/18/2006	AZ	67.0	66		M	01/18/2006	On 1/12/2006 patient received flu shot.  Wife states patient had episode of transient dizziness that evening.  Has been having light-headedness and dizziness off and on since that time.  This RN instructed the wife to take patient to his physician.  Wife felt symptoms might be related to flu shot.  Apparently she has already notified VAERS and called to request the vaccine lot number from the Health Department.									U	01/12/2006	01/13/2006	1	none known, to see physician	UNK	UNK	none	Denied illness or fever at time of vaccination.	History of Fluctuating Blood Sugar, history of bleeding ulcer			1						1	Dizziness	FLU3~SANOFI PASTEUR~U1868AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250524	01/18/2006	IN	14.0	14		F	01/18/2006	Approximately 7 hours after receiving vaccine (per mother)pt. c/o increased heart rate, chest hurting, room spinning and difficulty taking a deep breath.  No tx. per mom. Still c/o increased heart rate today 1/18/2006. Advised to call family physician.									N	01/17/2006	01/17/2006	0	None	UNK	UNK						1						1	Chest pain; Dyspnoea; Heart rate increased; Vertigo	FLU3~SANOFI PASTEUR~U1519AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB156AA~2~IM~RA~HEP B (ENGERIX-B)~1	USA		Influenza
0250531	01/19/2006	VA	7.0	7		M	01/13/2006	Left upper arm edematous.  Swelling from elbow almost to shoulder.  Better today than yesterday (01/13/2006).				Y						01/11/2006	01/11/2006	0	N/A	PVT	UNK						1						1	Oedema; Swelling	FLU3~SANOFI PASTEUR~U1826AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250532	01/19/2006	WV	0.64	0	.6	M	01/12/2006	2nd dose of infant flu vaccine given to pt on 1/9/06. At 11 pm this  evening pt. developed blank stare and face turned blue and felt hot. Pt taken to ER and Dx with acute febrile seizure. Tx with Motrin/Tylenol. Medical record states fever.				Y					Y	01/09/2006	01/09/2006	0	UA - negative - done in ER	PVT	PUB	NONE	NONE	Single Kidney Medical record states congenital abnormality.		WV0601	1						1	Cyanosis; Febrile convulsion; Feeling hot; Pyrexia; Staring	FLU3~SANOFI PASTEUR~U1787DA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250533	01/19/2006	NE	51.0	51		M	01/13/2006	Inflamed, hot, hard, fever 101, achiness and neck stiff.									Y	12/31/2005	01/01/2006	1		PVT	PVT	Inderal LA;Allopurinol;Albuterol Inhaler;Flonase;Claritin	NONE	Asthma Gout			1						1	Feeling hot; Injection site induration; Injection site inflammation; Musculoskeletal stiffness; Pain; Pyrexia; Erythema; Injection site inflammation; Musculoskeletal stiffness; Pain; Pyrexia	FLU3~SANOFI PASTEUR~41761AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1008P~1~IM~UN~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U1761AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1006P~2~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0250546	01/19/2006	TX	83.0	83		F	12/08/2005	Patient complained of having mild SOB, hoarseness, wheezing, that began 12/6/05.  Developed hives night of 12/7/05.  States took Benadryl capsules 2hrs or more ago.  Denies any reaction or problems at injection site.  Has had the vaccine yearly for many years.  Strongly advises to go to nearest emergency room for evaluation.  Client declined.  On a follow up report says client reports condition has improved.  Client states that they did go to ER as advised in report.  Client denies having SOB, wheezing, or hoarseness.  No longer has hives.  States she continues to take antihistamine.  Denies having any reaction at injection site.  Although advised to be evaluated by doctor promptly, client states she will see doctor as scheduled for checkup in January 2006.									Y	12/06/2005	12/06/2005	0	NONE	PUB	PUB	Benadryl, Thyroid, diovar		to oral antibiotics/heart disease			1						1	Dysphonia; Dyspnoea; Wheezing	FLU3~SANOFI PASTEUR~U1915AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250550	01/19/2006	VA	11.0	11		M	01/19/2006	Patient took the Flu vaccine  at 2:20 PM on 1/17/06.  Around 7PM my son started experiencing dizziness then around midnight spiked a high fever of 102 which lasted for two days.  The redness around his injection site was the size of a large orange. He became very lethargic sleeping most of the next day after the injection.  Also complained it felt hard to breathe and had stiffness.  He also said his feet tingled.  Gave Advil to bring down the fever.  This is the first time the patient has taken the flu vaccine.  He had no other symptoms such as coughing, sore throat, etc. to indicate other illness.									N	01/17/2006	01/17/2006	0		UNK	UNK	None	None	Suffers from seasonal mild allergies.			1						1	Dizziness; Dyspnoea; Injection site erythema; Lethargy; Musculoskeletal stiffness; Paraesthesia; Pyrexia; Somnolence	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0250551	01/20/2006	CA	45.0	44		F	01/17/2006	On 9th day after vaccination, patient had difficulty urinating. Patient was hospitalized the following day. While hospitalized patient lost sensation in lower half of body. Information from Discharge summary states viral infection, myelitis, urine incontinence. msv					Y	7			Y	10/28/2005	11/06/2005	9	Information from Discharge summary indicates abnormal CSF report, Abnormal lab testing. msv	OTH	PVT	UNK		From Discharge summary information confirms vascular anomaly. msv			1						1	CSF test abnormal; Dysuria; Laboratory test abnormal; Myelitis; Sensory disturbance; Urinary incontinence; Viral infection	FLU3~SANOFI PASTEUR~U1815AB~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0250554	01/20/2006	SC		53		M	01/17/2006	Body aches-esp leg and knee.  Problem now with pain left hand, middle finger and base left thumb, left wrist.									Y	12/21/2005	12/21/2005	0		OTH	UNK		Left hand and wrist pain	milk, bee stings			1						1	Arthralgia; Pain	FLU3~EVANS VACCINES~63194~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0250555	01/20/2006	CA	69.0			F	01/19/2006	Redness, swelling upper arm 8x6 inches.  Tried with ice and antibiotics.									Y					PVT	PVT	Oravan, Arumidix, Prevacid, ASA	NONE	Penicillin			1						1	Erythema; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61122~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0250569	01/20/2006	MT	47.0	47		F	09/07/2005	From initial information received on 12/17/2004 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 47 year old female patient received a dose of Fluzone, administered in the right deltoid and a dose of Menumune, administered in the left arm on 12/06/2004.  Routes of administration were not reported.  Ten days later, on 12/16/2004, the patient developed gastrointestinal upset, nausea, vomiting, diarrhea, severe generalized aching, aching behind the eyes and a headache.  In addition, she developed neck and spine stiffness.  The patient also felt feverish, but no temperature was taken.  Reportedly, the patient previously received flu vaccinations, but no reactions were reported.  Per the reporter, the patient has not recovered from these events.  Followup information received on 08/25/2005.  The patient received fluzone intramuscularly and received menomune subcutaneously.  Per the reporter, the patient recovered completely and was only ill for several days.  The patient previously told the reporter that she had Meningitis when working in a hospital and when she became ill after the shots, she was feeling like she did at the time of the meningitis - stiff neck and back, headache, etc.  To the reporter's knowledge, the patient did not have any other pre-existing conditions and was not on any other medications.  No lab tests were done or treatment given.  The reporter was unable to contact the patient further.									Y	12/06/2004	12/16/2004	10		PUB	UNK			It is unknown where the patient has any pre-existing medical conditions, birth defects or allergies.  She had no illnesses at the time of vaccination.  It is unknown if the patient was taking any concomitant medications at the time of vaccination.		200403993	1						1	Abdominal discomfort; Diarrhoea; Headache; Meningitis; Musculoskeletal stiffness; Nausea; Pain; Vomiting	FLU3~SANOFI PASTEUR~U1556AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~SANOFI PASTEUR~UE157AA~UNK~SC~~MENINGOCOCCAL (MENOMUNE)~1	USA		Influenza
0250591	01/20/2006	CT	16.0	15		M	01/14/2006	Progressive loss of balance, ataxia and speech abnormal. Lumbar puncture and clinical picture Guillain Barre. Ruled out intracranial lesion/process, metabolic, etc. From Discharge summary, discharge summary states celebellar ataxia, GBS disproven, WBCs found in CSF.				Y	Y	3			U	12/14/2005	01/03/2006	20		OTH	PVT	NONE		RAD			1						1	Balance disorder; CSF test abnormal; Cerebellar ataxia; Coordination abnormal; Speech disorder	FLU3~SANOFI PASTEUR~U1858AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0250592	01/20/2006	IL	1.63	1	.6	M		Rash on face, facial flushing the day after vaccines given.  Received Benadryl orally.  Also concurrent upper respiratory infection, otitis media.				Y					Y	01/12/2006	01/13/2006	1	NONE	PVT	PVT						1						1	Flushing; Otitis media; Rash; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~U1848AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~VE777AA~4~IM~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0601R~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08640F~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0250593	01/20/2006	CA	56.0	55		F	01/12/2006	Flu shot given in left arm on 1/11/06 at 6:15pm.  3hrs later extreme vertigo and dizziness. Unable to function or drive a car.  Today (1/12/06) still very dizzy and nausea.									N	01/11/2006	01/11/2006	0		PVT	PVT		NONE				1						1	Dizziness; Nausea; Vertigo	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62447~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|UNK~UNKNOWN MANUFACTURER~C2212AA~UNK~ID~LA~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA		Influenza
0250504	01/22/2006	VA	1.02	1	.0	M	01/22/2006	My son died in his crib 5 days after his one year immunizations and flu shot without warning.	Y	10/30/2005							N	10/25/2005	10/30/2005	5		UNK	UNK	Tylenol drops at night, only once, if needed for teething.	Teething, boogers in nose, heavy breathing during playtime.				1						2	Irritability; Pyrexia; Sudden infant death syndrome; Unevaluable event	FLU3~SANOFI PASTEUR~U1762AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0935P~UNK~~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0195P~UNK~~RL~VARICELLA (VARIVAX)~1|FLU3~SANOFI PASTEUR~U1762AA~1~SC~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|MMR~MERCK & CO. INC.~0935P~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~2|VARCEL~MERCK & CO. INC.~0195P~1~SC~RL~VARICELLA (VARIVAX)~2	USA	Results in Death	Influenza
0250581	01/22/2006	CA	41.0	41		F	01/22/2006	Woke at 7 AM this morning with severe diarrhea.									U	01/21/2006	01/22/2006	1		UNK	UNK	none	none	none			1						1	Diarrhoea	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0250730	01/23/2006		45.0			F	01/18/2006	Information has been received from a physician concerning a 45 year old female with type II diabetes mellitus who on approximately 11/07/2005 was vaccinated SQ with a dose of Pneumococcal 23v polysaccharide vaccine (lot #649914/0578P) and a dose of influenza virus vaccine (unspecified) into the opposite arm (unspecified). Concomitant therapy included an unspecified oral therapy. Subsequently the patient developed redness, pain and swelling to the arm that was used for the Pneumococcal 23v polysaccharide vaccine. Medical attention was sought and the patient received diphenhydramine hydrochloride (Benadryl) and prednisone. Subsequently, the patient recovered from redness, pain and swelling to the arm. The physician considered redness, pain and swelling to the arm to be other important medical events (OMIC). Additional information has been requested.				Y					Y	11/07/2005				OTH	OTH	Therapy unspecified		Type II Diabetes Mellitus		WAES0601USA01368	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0578P~UNK~SC~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0250733	01/23/2006	TN	76.0	76		F	11/09/2005	Client received Fluzone on 11/5/05. On 11/7/05 she began itching on back and head, around waist. It became worse on 11/8/05. On 11/9/05 itching not as bad. Is taking Benadryl and a cream for itching.									Y	11/05/2005	11/07/2005	2		PUB	PUB			PCN		TN05060	1						1	Pruritus	FLU3~SANOFI PASTEUR~U1838AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250734	01/23/2006	MO	81.0	80		F	01/12/2006	Profound myalgia upper extremities. Myositis. Several days after injection reaction at 6 wks post.									U	10/31/2005	11/02/2005	2	Sed rate = 45;LD4 - 190;CPR - 110	PVT	PVT	Inderal 120mg la and qd;Trental 400mg tid	NONE	CAD;Hyperlipidemia;Tremors			1						1	Myalgia; Myositis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~A126AC~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0577P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0250736	01/23/2006	WA	48.0	47		F	01/17/2006	6 weeks persistent left deltoid pain (injection site). Cannot exclude underlying rotator cuff syndrome. No visible/palpable exam findings.									N	12/01/2005	12/01/2005	0	NONE	PVT	UNK		NONE	History left rotator cuff syndrome 2 yrs prior.			1						1	Injection site pain; Rotator cuff syndrome	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62217~2~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0250737	01/23/2006	NM	15.0	15		F	12/30/2005	PCV7 0.5 ml sub-q right arm given on 12/2//05. 12/30/05 at 16:00 received call fro mom. Inj. site red with 3 1/2 - 4 diameter. Temp 99.8. Advised ice pack and ibuprofen. Call on call physician if necessary.									Y	12/28/2005	12/29/2005	1		PUB	PUB	Singular;Zyrtec 10mg;Albuterol MPI;Asmanox	Cough;Ear ache				1						1	Injection site erythema; Pyrexia	FLU3~SANOFI PASTEUR~U1864AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1784AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PNC~PFIZER\WYETH~B08643A~UNK~SC~RA~PNEUMO (PREVNAR)~1	USA		Influenza
0250738	01/23/2006	NY	76.0	76		M	01/17/2006	On 1/10/06 pt received influenza and pneumococcal vaccine in the left deltoid area. Pt returned on 1/13/06 reporting increased swelling and redness in this area. DR. assessed pt placed on Augmentin 875 mg bid x8 days.				Y					Y	01/10/2006	01/12/2006	2		PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U1787CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~AVENTIS PASTEUR~U1596CA~1~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0250739	01/23/2006	OH	12.0	11		M	01/18/2006	Left arm 16 x 20 cm induration with edge of erythema central pallor, warmth administered 9:30 swelling by 5 pm follow day current description. Right arm 4 x 4.5 cm total erythema, swelling, warmth at sit of Menactra 24 hours later.									Y	01/16/2006	01/16/2006	0	NONE	PVT	PVT	Singular 5mg qns;Advair 100/20 one BID; Zyrtec D one BID	NONE	Asthma;Allergy to ibuprofen, aspirin;Suspected allergy to shellfish.			1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth; Pallor; Dizziness; Erythema; Injection site oedema; Medication error; Nausea; Erythema; Feeling hot; Injection site induration; Injection site inflammation; Injection site reaction; Oedema peripheral; Swelling	FLU3~SANOFI PASTEUR~U1753AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1782AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PPV~MERCK & CO. INC.~0605R~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~651524/0605R~UNK~IM~~PNEUMO (PNEUMOVAX)~2|FLU3~SANOFI PASTEUR~U1753AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|MNQ~SANOFI PASTEUR~U1782AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~3|PPV~MERCK & CO. INC.~0605R~1~IM~LA~PNEUMO (PNEUMOVAX)~3	USA		Influenza
0250740	01/23/2006	MI	47.0	47		M	11/15/2005	First day after receiving vaccine- tired. Second day - malaise, fever. Third day - headache, muscle aches, runny nose, chest congestion, ear pain, anorexia, insomnia.									N	11/09/2005	11/10/2005	1	NONE	PUB	PVT	Zyrtec;Flonase;Astelin	NONE	Seasonal allergies		MI2006002	1						1	Anorexia; Ear pain; Fatigue; Headache; Insomnia; Malaise; Myalgia; Nasal congestion; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500393P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0250741	01/23/2006	MI	41.0	41		M	12/14/2005	Received FluMist on Thursday and by Friday afternoon had runny nose, sneezing and body aches. These symptoms lasted for 3 days after which the body aches subsides, but there was lingering stuffiness and runny nose for a couple of weeks.									Y	11/03/2005	11/04/2005	1	NONE	PUB	PVT		NONE	Spring and Fall Seasonal Allergies (different symptoms).		MI2006001	1						1	Nasal congestion; Pain; Rhinorrhoea; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~500387P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0250742	01/23/2006	DE	76.0	76		F	10/31/2005	Low BP (80/60), diaphoresis, lightheadedness, pallor. Orange juice and granola bar given. 10/31/05 12:05 pm influenza vaccine .5cc administered in left deltoid per standing order. Consent signed. Pt reports I feel lightheaded, BP taken 80/60, diaphoresis and pallor noted. Pt alert and oriented, answering questions. Granola bar and orange juice given. Paramedics called. 10/31/05 12:10 pm report given to paramedics. Pt stated she gave blood (pleresis) earlier this AM. Pt still conscious drinking juice. State that she is embarrassed  and that paramedics not necessary. Pt states she feels better. Reassured pt paramedics is necessary and PHN wants to ensure that she is alright. 10/31/05 12:15 pm waiting with pt for paramedics. Pt sitting in chair, stable, conscious, answering questions. Pt states she feels lightheaded again and diaphoresing. Paramedics arrived. 10/31/05 12:20 pm Paramedics here. O2 given and VS taken. Pt taken to hospital. Will follow-up with VAERS and pt status. 11/1/05 4:30 pm T/C to pt home. Spoke to pt. Pt states that she is fine, was taken to hospital care ER and was evaluated and sent home stable. No follow up needed.				Y					N	10/31/2005	10/31/2005	0	NONE	OTH	PUB	NONE	NONE	NONE			1						1	Blood pressure decreased; Dizziness; Hyperhidrosis; Pallor	FLU3~SANOFI PASTEUR~U1815AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250743	01/23/2006	DE	52.0	52		F	11/17/2005	Client report generalized itching within the hour after receiving flu shot.  Took Benadryl.  Went to physician that evening-Temp 100 had swollen glands 11/13/05.									Y	11/11/2005	11/11/2005	0	Throat culture-negative for strep	PUB	PUB	NONE	NONE	Sarcoidosis lung			1						1	Lymphadenopathy; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~01936~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250744	01/23/2006	OR	1.11	1	.1	F	01/09/2006	rash over body developing on 1/8/06.  Flat red areas over body, face, scalp.  Per 1/19/06 TV with mom.  Rash lasted 5 days now gone.				Y					Y	12/30/2005	01/08/2006	9	NONE	PVT	PUB	Amoxicillin	Bilateral osteoradionecrosis	NONE		OR200602	1						1	Rash	FLU3~SANOFI PASTEUR~U1914AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0529R~4~IM~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0601R~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0417R~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0250745	01/23/2006	WY	43.0			F	01/11/2006	Joint achiness and chills evening of vaccination.									Y					PUB	UNK		NONE	NONE but had allergy to Thermisol in the past.			1						1	Arthralgia; Chills	FLUX~UNKNOWN MANUFACTURER~AFLUA153AA~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0250746	01/23/2006	WY	60.0	59		F	12/01/2005	General achiness, headache, dizziness.									Y	10/25/2005			NONE	PUB	UNK						1						1	Dizziness; Headache; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA153AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0250747	01/23/2006	WY	36.0	36		M	12/01/2005	Flu like symptoms and vomiting at 3AM.									Y	10/27/2005	10/28/2005	1		PUB	OTH	NONE	NONE	NONE			1						1	Influenza like illness; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA153AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0250748	01/23/2006	TN		8		M	01/05/2006	Right arm red, swollen about the size of two quarters.  Treat with cold compress and Tylenol for pain.									Y	01/03/2006	01/04/2006	1		PVT	PVT		NONE	NONE			1						1	Erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U1915AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250749	01/23/2006	TN	11.0			M	12/10/2005	Reaction of L deltoid to flu vaccine on 12-8-05. 6x4 cm pink and slight raised.  No temp.  No allergies to egg.									Y					PVT	PUB		NONE	NONE			1						1	Erythema; Injection site reaction; Injection site swelling	FLU3~SANOFI PASTEUR~U1063AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250750	01/23/2006	AL	78.0	77		F	01/09/2006	Patient states received flu shot 12-14-05.  States nurse stated blood ran down arm.  Arm hurt that day and next day arm blue around injection site and remained for two weeks.  Patient noticed 1-7-06 that deltoid swollen and appeared bruised.  Patient states they were applying alcohol since injection received.  States arm is stinging and feels hot today.									N	12/14/2005	12/14/2005	0		PUB	UNK	Caltrate, Aspirin, Tylenol prn	NONE	No known drug allergies			1						1	Contusion; Feeling hot; Haemorrhage; Injection site reaction; Pain; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62755~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0250765	01/23/2006	IA	79.0	78		M	01/19/2006	Received pneumovax 01/10/2006 in left deltoid on 01/10/2006.  Developed redness, warmth, edema from site distally to hand.  Received Benadryl 25mg every 4 hours as needed and ice pack as desired.  Rash persisted thru 01/14/2006.									Y	01/10/2006	01/11/2006	1	NONE	PUB	UNK	Methadone HCL, Enalapril, Prednisone	NONE	None Known			1						1	Erythema; Feeling hot; Oedema; Rash	FLUX~UNKNOWN MANUFACTURER~0371P~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0250767	01/23/2006	VA	48.0	47		M	01/23/2006	10cm x 6cm area on R deltoid with slight edema, erythema, warm to touch. No streaking. Neuro/vascular intact. Postive joint pain in R shoulder x 2 days (resolved today). No SOB.									U	01/20/2006	01/21/2006	1	N/A	UNK	UNK	Lorazepam, Lorcet, Amaryl, Hctz, Albuterol, Combivent, Advair, Lasix, Lipitor, Coreg, KCl, Lisinopril, Aldactone, Flonase	No acute	NKDA DM, HTN, OSA, CHF, CAD, Pulmonary HTN, Dyslipidemia			1						1	Arthralgia; Injection site erythema; Injection site oedema; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62013~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0250768	01/23/2006	TX	57.0	56		F	01/23/2006	The injection was given high and posterior and the nurse said it felt like the needle hit something that felt like burlap.  I had severe pain at the sight but know that is common side effect but then I had weakness and pain of the arm that went past the 4 days so I reported it to the appropriate department.				Y					N	11/03/2005	11/03/2005	0	Brachial Plexitis per physical medicine specialist who did an EMG and complete examination of musculature and nervous system.	UNK	UNK	Synthroid Actonel Prevacid since actonel irritated Stomach	None	Osteopenia, goiter.			1						1	Injection site pain; Muscular weakness; Myalgia	FLU3~SANOFI PASTEUR~U1802DA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250781	01/23/2006	IN	30.0	29		F	01/23/2006	Vaccine failure, flu shot on 11/08/2005.  patient tested flu A positive on 01/23/2006.									Y	11/08/2005	01/22/2006	75	Nasopharyngeal swab Flu A, Flu B, RSV, Rapid Test	PVT	PVT	Glucophage, Reglan, Santura, Imdur	Asthma, Obesity	Headache, Anxiety/Depression/PTSD, Obesity, Blind in left eye			1						1	Drug ineffective	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61998~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0250794	01/24/2006	PA	37.0	36		F	01/20/2006	Contracted cellulitis within hours of receiving flu shot. Extremely sick almost hospitalized. I was on antibiotics for 14 days.			Y	Y					Y	12/02/2005	12/02/2005	0		OTH	PUB			Penicillin allergy			1						1	Cellulitis; Malaise	FLU3~SANOFI PASTEUR~U1903AA~UNK~SC~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0346R~UNK~SC~UN~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening	Influenza
0250795	01/24/2006	GA	1.05	1	.1	F	01/18/2006	13 month old male with rash - possible measles. Plus fever to 101.6. Had MMR vaccines 3 one week ago - broke out in rash yesterday evening after bath. Began on chest/neck and spread to entire body - less on arms/legs- rash not bothersome. Also has red/watery eyes.  ____ok ______ activity.									U	01/05/2006	01/15/2006	10		PUB	PUB	NONE	URI	NONE			1						1	Erythema; Lacrimation increased; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U1765FA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0631R~3~~LL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~9104510~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A98341D~4~~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0250796	01/24/2006	PA				U		Cellulitis, vomiting, diarrhea, high fever, dizziness, lethargy, loss of appetite.									Y	12/02/2005				OTH	PUB	Ortho Tri-Cyclen					1						1	Anorexia; Cellulitis; Diarrhoea; Dizziness; Lethargy; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1903AA~UNK~SC~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~U346R~UNK~SC~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0250797	01/24/2006	ME	1.13	1	.1	F	01/18/2006	Rash immediately after vax given, 5 days following shot pt developed a thick lump that grew larger - no documented visit for this reaction.									U	01/03/2006	01/03/2006	0		PVT	OTH	NONE	S/P OMG;UTI on 12-21-05	NONE			1						1	Injection site mass; Rash	FLU3~SANOFI PASTEUR~U1788EA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0784~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0250798	01/24/2006	ME	44.0	43		F		Anaphylaxis, blurred vision, fever, cough, swelling of lips and eyes, myalgias symptoms lasted from 3 pm until 8 am 12/6/05. Recovered fully.				Y					Y	12/05/2005	12/05/2005	0		PVT	PUB						1						1	Anaphylactic reaction; Cough; Eye swelling; Myalgia; Pyrexia; Swelling face; Vision blurred	FLU3~SANOFI PASTEUR~U1914AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250799	01/24/2006	FL	50.0	49		F	01/13/2006	2 days after shot, began with erratic muscle pain, after tingling chest, shoulder, arms and thighs. Initially treated with Advil x 2 weeks and partial relief of symptoms, got worse and visits to ER x 2 (times) within next week. Then my PCP and finally rheumatologist. All testing has been negative so far.				Y					N	12/12/2005	12/14/2005	2	Shoulder and Hip X-rays;CBC;BMP;Thyroid panel;Rheumatoid panel;CPIC;ESR	OTH	PVT		NONE				1						1	Myalgia; Paraesthesia	FLU3~SANOFI PASTEUR~U1826AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250800	01/24/2006	WA	27.0	26		M	01/18/2006	Continuous sinus problems, pressure, having to blow nose once every hour or two from late October to early January. Sinus polyp found on x-ray. Unknown if related.									U	10/07/2005	10/15/2005	8	Head X-ray	MIL	MIL		NONE	Cancer Survivor			1						1	Sinusitis	FLUN3~MEDIMMUNE VACCINES, INC.~500387P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0250801	01/24/2006	WA	33.0	33		F	01/17/2006	Had influenza nasal spray in October 2005, has had sinus problems since. Boggy nasal turbinates today with clear exudate. If not better by next week will CT sinuses. This is third patient that has reacted in this clinic.									N	10/07/2005	10/08/2005	1	CT Pending	MIL	MIL	NONE	NONE	NONE	May 1993~Typhoid Vi Polysaccharide (no brand name)~1~20.00~In Patient		1						1	Sinusitis	FLUN3~MEDIMMUNE VACCINES, INC.~500387P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0250828	01/24/2006	WI	48.0	47		F	01/24/2006	I receved flu and pneumococcal vaccine on 11-08-05 were I work at 1:15 pm. The flu shot went in my right arm and pneumococcal in the left arm.  I felt some stinging after the pneunococcal shot was given in the left arm but didn't make anything of the situation.  By 5:00 PM I went to the office and told the first aid person to look at my left arm because it felt like it was on fire and I couldn't raise my arm.  She took one look at it and called the head person of first aid on my shift and decided to take me up to the hospital to have a doctor look at my left arm because of the red lump and burning pain I could not even raise my arm it hurt so bad.  At the hospital they took me to see the doctor that was on call.  The doctor told me that I develop a sit reaction to the pneumococcal shot and told me to home and put a warm compress on the site reaction.  I followed her instructions.  The next day Wed. 11/09/05 I went into work and by 7:00 PM I felt achy and feverish and finish my shift went home at 10:00 pm I took 3 Advil and went right to bed.  The next day Thurs 11/10/05 I  planned to go into work as I was undressing I looked in the mirror to examine my left arm to see if the site reaction was going away then I noticed red streaking on my left arm elbow up forward and back and under arm and into the chest area.  The time was about 12:15 pm I called work to let them know that I was going back to the hospital ER and was'nt planning on coming into work.  I arrived at the hospital and the doctor examined me and told me that I had infection and ordered an IV filled with strong antibotics along with a tetanus shot.  He also ask me if I had the lot number or the pneumococcal vaccine and I gave him the number which was 0876R exp 4Aug07 and called the hospital where the shot came from and to pull that lot number.  The next I went to see my family doctor and ask her if I had blood poisoning and she said yes and that I was grateful to notice the signs of the red streaking and went to the emergency clinic.  The reason why I get these vaccinations is to stay healthy because I have M.S. Information received from Medical records states cellulitis. msv			Y	Y					U	11/08/2005	11/08/2005	0	none	UNK	UNK	Avonex for treatment M.S., paxil 20mg, clonazepam 1mg levothyroxine 137mg	Site reaction and blood poisoning.	Multiple Sclerosis, under active thyroid.			1						1	Cellulitis; Erythema; Hypokinesia; Injection site infection; Injection site mass; Injection site pain; Injection site reaction; Pain; Pyrexia; Skin striae	FLU3~SANOFI PASTEUR~U1862AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0876R~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening	Influenza
0250829	01/24/2006	NY	44.0	43		F	01/24/2006	Immediately experienced a migraine, felt loopy and just wanted to lay down.									Y	11/22/2005	11/22/2005	0		UNK	UNK		None	Hx. of migraines.			1						1	Dizziness; Migraine	FLUN3~MEDIMMUNE VACCINES, INC.~500U26P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0250830	01/24/2006	IL	72.0	71		F	01/24/2006	On 1/20/06 patient telephoned to Department of Health. Pt. states aprox. 5 days post vaccination(10/21/05) had rash on back, arm leg and feet, which later blistered.  Pt. was evaluated by pvt. MD.  Pt. states doctor informed her that rash was due to the flu and/or pneumonia shot. Doctor is on vacation until 1/31/06 and is not available for confirmation.  Pt. also states that has blisters on feet and has home health nurses to come weekly to do foot and dressing care. Pt. states had received flu shot before, but this is the first time received pneumo shot. Pt. is very clear that MD did not tell her she had shingles and was told by MD it was reaction to the shot.				Y					Y	10/21/2005	10/26/2005	5		UNK	UNK	Medication for HTN	UNK	HTN			1						1	Blister; Rash	FLU3~SANOFI PASTEUR~U1805AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0748P~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0250831	01/24/2006	IL	29.0			F	01/24/2006	Complained of tongue feeling thick and numbness right side of face 30 minutes after vaccine was given. No SOB, or distress. Alert and oriented. VS:@1122:P=72,R=24,B/P=125/80    @1133:P=88,R=18,B/P=132/80    @1148: P=78; RR=18; B/P=124/80    @1203: P=70; RR=19, B/P=102/60 Epi 1:1000 .75mg intramuscular to Left arm @11:25									Y				NA	UNK	UNK	None	None known	None Known			1						1	Blood pressure decreased; Hypoaesthesia; Tongue disorder	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62939~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0250833	01/24/2006	AK	54.0	54		M	01/24/2006	PATIENT DEVELOPED CELLULITIS AT THE SITE REQUIRING ANTIBIOTICS APPROXIMATELY TWO DAYS AFTER INJECTION.									Y	12/28/2005	12/30/2005	2		UNK	UNK		HEP C				1						1	Cellulitis; Injection site reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61321~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1044P~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0250838	01/24/2006	CA	7.0	6		M	01/24/2006	Hives on shoulder. The next day he experienced a heavy feeling in his chest.									Y	01/19/2006	01/19/2006	0		OTH	UNK			Slight Asthma			1						1	Chest discomfort; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500395P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0250839	01/24/2006	IN	34.0	34		F	01/23/2006	Vaccine failure.  Flu shot on 11-7-05. Flu A positive and symptomatic on 01-23-06.				Y					Y	11/07/2005	01/22/2006	76	Binax Now Flu A, Flu B, RSV Nasopharyngeal swab rapid test.	PVT	PVT	NONE	NONE	NONE			1						1	Dyspnoea; Influenza; Vaccination complication	FLU3~SANOFI PASTEUR~6199B~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250840	01/24/2006	IN	3.0	3		M	01/24/2006	Vaccine failure. 1st 1/2 dose on 10-27-05. 2nd 1/2 dose on 11-29-05.  Flu A positive and symptomatic on 1-23-06.				Y					Y	10/27/2005	01/21/2006	86	Binax Now Flu A, Flu B, RSV, Nasophanengeal swab rapid test	PUB	PUB	Zyrtec 1mg/ml, 1.2 tsp poqd	NONE	Chronic Allergic Rhinitis & recurrent acute otitis media			1						1	Influenza; Respiratory disorder; Vaccination complication	FLU3~SANOFI PASTEUR~U1765FA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250841	01/24/2006	CA	10.0	10		F	01/24/2006	Flu and Pneumovax given on Dec 7 2005.  Since vaccine running increased fever, malaise, myalgias.  And testing CRP, bloodwork etc negative, fever on and off about 6 weeks.  Had redness, swelling, tenderness to R arm site 2 days after inject given. Still running on and off fever, malaise, myalgias.									N	12/07/2005	12/08/2005	1	CXR, mono, CBC, chem panel-Epsilon Barr Virus panel sed rate done.  WBC increased on 12/10/05-now NL.  Had fever steady on 12/8/05 temp up as 105.	PVT	UNK		Sinus infection	Diabetic			1						1	Erythema; Malaise; Myalgia; Pyrexia; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U1865AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1047P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0248502	01/25/2006	MI	78.0	78		M	11/15/2005	Client reports raised red papule (pimples) that began as red blotches on anterior, posterior torso, spreading to arms and legs.  Very pruatic; papules had no discharge.  Denies dyspnea, heart palpitations, rash. Saw Dr 10/26/05 and 10/27/05 (Biopsy done).  Received antibiotics, anti-prumatic. Saw Dr on 11/7/05. Lesions began resolving 10/28/05.				Y					Y	10/20/2005	10/24/2005	4	3 mm punch biopsy	PUB	PUB	oral hypoglycemic for diabetes, hypertension medication, Plavix	NONE	hypertension, diabetes, hypercholesterol			1						2	Acne; Neoplasm skin; Skin ulcer	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0250850	01/25/2006	IL	6.0			F	01/20/2006	Initial report received on 01/16/2006 from the patients parent. A six year old female patient with no significant past medical history had received an intramuscular injection of Fluzone SV 2005-2006 USP, lot number U1814AA, in the arm site nor reported, in Nov 2005 day not reported. Immediately after the injection was administered, the patient had pain and weakness in the right leg and difficulty walking. The patient was admitted to the hospital on 01/06/2006 and was later transported to a hospital on 01/10/2006. The patient was discharged from the hospital on 01/13/2006. Per the reporter, the patient was diagnosed with muscular skeletal pain. Relevant tests performed were MRI's, bone scan, cat scan of the abdomen and spinal tap (date and results not reported). At the time of this report, the patient had not recovered.					Y	8			N					UNK	UNK			Per the reporter, the patient had no illnesses, pre-existing medical conditions or use of other medications at the time of the vaccination.		200600122	1						1	Asthenia; Bone pain; Difficulty in walking; Myalgia; Pain	FLU3~SANOFI PASTEUR~U1814AA~1~IM~AR~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0250852	01/25/2006	NC	5.0	5		F	01/19/2006	Red allergic urticaria L upper arm 1.5 x 7/8 at site of of IPV vaccine.  We start cream BID to skin and oral Benadryl.				Y					Y	01/17/2006	01/19/2006	2	NONE	PVT	PVT	NONE	NONE	Allergic to Amoxicillin			1						1	Injection site erythema; Injection site urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B005AA~5~~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~V1863AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0298~4~~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0609P~2~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0250857	01/25/2006	OH	26.0	25		M	12/03/2005	15 minutes after receiving shot, became light-headed, noticed hive-like rash on both upper arms.  Patient describes feeling warm, diaphoretic, facial pallor noted.  Patient reported back to clinic, seen by physician's assistant and assessed heart rate, blood pressure and remained in office for observation.  Patient reports symptoms subsided around 10:30AM.									Y	12/03/2005	12/03/2005	0		MIL	MIL	Nexium Paxil	light-headed, flushed, diaphoretic, pale	None known			1						1	Dizziness; Feeling hot; Flushing; Hyperhidrosis; Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~~7+~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0250858	01/25/2006	MD	19.0	19		F		Approximately 15mm sl. erythema at site.  Twenty minutes after leaving facility, mother phoned stating area was 25 cents size red and uncomfortable.   01/25/2006 Patient returns for PPD reading above site of error - approximately 35mm, sl. erythema and raised - states doesn't bother me.  Advised may persist several weeks, review as needed.									Y	01/23/2006	01/23/2006	0	Montoux PPD - lot number C2212AA, right arm	OTH	PUB		NONE	NONE			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U1914AA~UNK~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250893	01/26/2006	NY	48.0	47		M	01/26/2006	On the am of 11/7/05, awoke with an inability to focus his eyes on the alarm clock and he was unable to walk independently.  He went to his primary MD-who reported severe nystagmus and ataxia.  He was started on Antivert for possible acute labyrnthitis and an MRI was ordered for rule out MS.				Y					Y	11/05/2005	11/07/2005	2	MRI-acute labyrnthitis	UNK	UNK	Lipitor, Glucosamine, MVI, Vitamin E, ASA	On 11-4-05, felt if he may be coming down with a cold-it never developed into a cold.	High cholesterol			1						1	Coordination abnormal; Difficulty in walking; Labyrinthitis; Nystagmus; Visual disturbance	FLU3~SANOFI PASTEUR~1747AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250897	01/26/2006	MO	50.0	50		F	12/28/2005	That evening kept itching, could not stop. Next day light rashes, itching was uncontrollable. Went to pharmacy. Bought itch cream and allergy medication as suggested by pharmacist after I told her about the vaccine shot I received. Sunday I was swollen twice the size and could not breath. Went to ER and received a shot and medications from pharmacy, said my respiratory system could have shut down.  Information from medical records state hypertension as finding. msv			Y	Y					Y	11/03/2005	11/03/2005	0		OTH	PVT						1						1	Dyspnoea; Hypertension; Oedema; Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0250900	01/26/2006	CA	55.0			M	01/18/2006	Received flu vaccine on 10/24/05. One week later developed numbness related to cranial nerve 9. Symptoms lasted for 10-12 weeks. Examined by a neurologist and expects a full recovery (OMIC)									Y	10/24/2005	10/24/2005	0		UNK	UNK						1						1	Hypoaesthesia; Hypoaesthesia	FLU3~SANOFI PASTEUR~AFUA130AB~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~AFUA130AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0250901	01/26/2006	FL	13.0	13		M	01/20/2006	Pt received vaccine in afternoon of 01/13/2006, developed generalized hives the morning of 01/14/2006. Seen in ER, received Benadryl PO. Took PO Benadryl x 2 days.				Y					Y	01/13/2006	01/14/2006	1		PUB	PUB		NONE	Asthma			1						1	Urticaria	FLU3~SANOFI PASTEUR~41936AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250902	01/26/2006	CA	0.5	0	.5	M	01/20/2006	Rapid onset of macular rash within 2 hours after immunizations.  Trunk to extremity spread, spares hands, feet, mucosa.  Rectal temps 99.4 within 12 hours later increased 101.4.  Today approximately 75 hours later afebrile, rash remains.									Y	01/17/2006	01/17/2006	0	NONE	PUB	UNK	NONE	NONE	NONE			1						1	Pyrexia; Rash macular	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B010AA~3~~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1765HA~UNK~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0205R~3~~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08637K~3~~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0250935	01/27/2006	NJ	6.0			M	01/23/2006	Initial report received from another company and a health care professional on 1/19/2006. A six year old male patient with no medical history, had received a dose of Fluzone no preservative 2005-2006, lot number U1742JA, on 1/27/2005. The route and site of administration were not reported. Approximately one week post vaccination, the patient developed vomiting and a fever, which may have been as high as 103 degrees F as per the reporter. The patient was also achy, had joint pain and hip pain. X rays and MRI of the hip were negative. The reporter stated that the information was given to her by the patients mother, who reported that the patient seems to get better and then becomes worse again. The patient is currently being worked up for lyme disease. The reporter stated that she believed the patient was hospitalized for the events. He has not recovered and is under a physicians care.  (OMIC)				Y	Y	0			N	12/27/2005				UNK	UNK					200600138	1						1	Arthralgia; Pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1743JA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0250939	01/27/2006	GA	0.83	0	.8	F	01/24/2006	Patient seizure, and was taken to Hospital.					Y	1			Y	11/18/2005	11/18/2005	0		PVT	PUB	NONE					1						1	Convulsion	FLU3~SANOFI PASTEUR~U1787GA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0250940	01/27/2006	TN	65.0	65		F	12/20/2005	Complaint of pain in left arm approximately one week ago in ability to hold anything in left arm.  Seen by the doctor, states patient was immunized in the tendon causing inflammation, prescribed prednisone and Advil.				Y					Y	11/18/2005	12/14/2005	26	NONE	OTH	PVT	Premarin, Levoxyl				TN05070	1						1	Pain; Tendonitis	FLU3~SANOFI PASTEUR~U1915AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250941	01/27/2006	TN	37.0	36		F	12/05/2005	Patient came to clinic today, left arm red, about size of half dollar.  Has taken Benadryl.  Flu shot in past no trouble.  Family had flu shots, shes the only one with redness - no fever, no swelling.  Is broken out with bites from camping - will see the doctor on Tuesday 12/06/2005.									Y	12/02/2005	12/03/2005	1		PUB	PUB	NONE				TN05069	1						1	Erythema	FLU3~SANOFI PASTEUR~U1915AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250942	01/27/2006	TN	46.0	46		F	12/09/2005	Patient reports exacerbation of MS including extreme fatigue which began 2 days post vaccination, lasted approximately 1 week and increased visual acuity in the left eye which occurred approximately 4 days post vaccination.  Reports about 90% of visual acuity has now returned.  Patient did not receive any medical attention for these reactions.									N	11/02/2005	11/04/2005	2	NONE	PUB	PUB	NONE	NONE	Multiple Sclerosis		TN05068	1						1	Fatigue; Visual disturbance	FLU3~SANOFI PASTEUR~U1744AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250943	01/27/2006	TN	40.0	39		F	11/28/2005	Received flu shot 11/07 - symptoms started 2 days later - itching under arms and ribs - went away after 7 hours - started again Thursday afternoon went away that night - again Friday PM - went away within hours.  Saturday early itching.  Had whelps not sure if due to immunizations.  Whelps all over body.  Shot of cortisone by doctor, zpak, Zyrtec.  Per doctor possible allergy to preservatives in flu shot.									Y	11/07/2005	11/09/2005	2	NONE	PUB	PUB		NONE	Allergy to penicillin/bactrim DS		TN05067	1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1744AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250944	01/27/2006	TN	31.0	31		F	11/17/2005	Patient began to have heart palpitations, sweating and headache - arm at injection site was painful.  Took BENADRYL - onset approximately 1 hour after injection.									Y	11/17/2005	11/17/2005	0		PUB	PUB		NONE	NONE		TN05066	1						1	Headache; Hyperhidrosis; Injection site pain; Palpitations	FLU3~SANOFI PASTEUR~U1915AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250945	01/27/2006	TN	53.0	53		F	11/16/2005	Flu shot left arm about 8am went to PCP at 9:30 am received pneumonia left arm also, PPD same time right forearm. later that night 6 or 7 pm. hurting left arm, nauseated, fever 101, red goose egg on left upper arm. Saw PCP on Wed 11/09/2005 stayed off work until Mon 11/14/2005 PCP took a picture of arm no treatment, arm sore today 11/16 feels ok otherwise.									U	11/07/2005	11/07/2005	0	Blood, urine draw, 11/07, PE on 11/29	PVT	PUB	NEXIUM; COZAAR	no	HTN		TN05065	1						1	Injection site hypersensitivity; Injection site mass; Nausea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1744AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~~1~UN~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0250946	01/27/2006	TN	36.0	36		F	11/09/2005	36 hours later noticed pain right deltoid rash on right arm, also back, no energy, flushed, slight body aches, no sob, (D+C after miscarriage m month ago). T96.8, BP 100/70, Lung CTA BL BS.									U	11/07/2005	11/08/2005	1		PUB	PUB		NONE			TN05064	1						1	Asthenia; Flushing; Injection site pain; Pain; Rash	FLU3~SANOFI PASTEUR~U1744AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250947	01/27/2006	TN	40.0	39		F	11/09/2005	24 hours after getting flu shot left arm starting itching and sore like a bruise, NKA, on 1 med Hypertension Zelnorm, and another med Enalapril. No SOB, no rash/hives. 4x2 cm red raised tender to touch left deltoid.									U	11/07/2005	11/08/2005	1		PVT	UNK			Hypertension, Tooth filled Sat 11/05/2005		TN05063	1						1	Contusion; Injection site hypersensitivity; Injection site pain; Injection site swelling; Pruritus; Tenderness	FLU3~SANOFI PASTEUR~U1838AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0250948	01/27/2006	SD	10.0	9		M	01/23/2006	flat, hive all over, TX Atarax 10mg 5cc's 4-5 times daily for itching.				Y					Y	01/13/2006	01/18/2006	5		PVT	PVT	NONE	Viral URI	Allergy to Amoxicillin			1						1	Pruritus; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500390P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0250949	01/27/2006	WA	0.5	0	.5	F	01/23/2006	Rash-macular/papular-head to toe									U	01/19/2006	01/19/2006	0		PVT	PUB		RSV in previous 10-14 days	Prematurity-34 weeks			1						1	Rash macular; Rash papular	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B008AA~3~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1773AA~1~SC~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE773AA~3~IM~LL~HIB (PROHIBIT)~1|PNC~PFIZER\WYETH~B08637AA~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0250950	01/27/2006	NM	49.0	48		M	01/25/2006	Pain, weakness and decreased range of motion of L arm since 11/3/05 when Pneumovax injection was given in L arm (deltoid).  Affects entire arm from L shoulder to forearm (on of sensation.  Seen in clinic 1/3/05 and 1/19/05 with same symptoms.										11/03/2005	11/03/2005	0	Referral to Neurology pending	PVT	PVT	NONE	NONE	Obesity, No known drug allergies			1						1	Joint range of motion decreased; Muscular weakness; Pain	FLUX~UNKNOWN MANUFACTURER~U177BAA~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0055R~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0250982	01/27/2006	ME	67.0	67		M	01/23/2006	About 1 week after administration of Td. Since it has been sore which has limited range of motion.  No redness, swelling.  Note induration at the time.				Y					N	09/27/2005	09/29/2005	2	NONE	PVT	PUB	NONE					1						1	Injection site induration; Joint range of motion decreased; Myalgia	FLU3~SANOFI PASTEUR~~6~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~UNKNOWN MANUFACTURER~~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0250974	01/29/2006	PA	60.0	59		M	01/29/2006	Patient developed pruritic maculopapular eruption first on legs then back and torso 7 hours after receipt of Fluzone vaccine.  Diagnosed by dermatologist as erythema multiforme, treated with high-dose prednisone over 2 weeks, with good response and no recurrence.				Y					Y	11/28/2005	11/28/2005	0		UNK	UNK	None	None	Chronic lymphoctic leukemia, non-progressive with stable lymphocyte counts.			1						1	Erythema multiforme; Pruritus; Rash maculo-papular	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0250900	01/30/2006	CA	55.0	55		M	01/30/2006	Received flu vaccine on 10/24/2005 one week later developed numbness related to cranial nerve 9. Symptoms lasted 10-12 weeks.									Y	10/24/2005	10/31/2005	7	UNK	PUB	OTH	UNK		UNK			1						2	Hypoaesthesia; Hypoaesthesia	FLU3~SANOFI PASTEUR~AFUA130AB~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~AFUA130AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0250997	01/30/2006	IA	33.0	33		F	01/26/2006	Information has been received from a physician concerning a normally very healthy 33 year old white female non-smoker with a history of acute otitis media, caesarean section requiring hospitalization, and an allergy to clarithromycin (Biaxin) who on 25-Nov-2005 at 09:30 am was vaccinated in the right deltoid with an eighth dose of pneumococcal 23v polysaccharide vaccine (lot #A651319/1007P). Illness at the time of vaccination included bilateral maxillary sinusitis. The patient was hospitalized for cellulitis from 28-Nov-2005 to 29-Nov-2005. The patient recovered on an unspecified date. A product quality complaint was not involved. Additional information has been received from a physician's office. On 26-Nov-2005, the patient had localized redness and warmth at the injection site. As the day went on, the redness doubled in size and was painful. The patient had nausea and vomiting. She was treated with amoxicillin (+) clavulanate potassium (Augmentin), guaifenesin, nalbuphine hydrochloride (Nubain), promethazine hydrochloride (Phenergan), azithromycin (Zithromax), and levofloxacin (Levaquin). It was noted that the symptoms started on 26-Nov-2005 and required the patient to be hospitalized for one day. Medical records from the patient's hospitalization included a history and physical which indicated that the patient was seen by her family physician on 25-Nov-2005 for a cold and was diagnosed with an upper respiratory infection and sinusitis. She was placed on oral amoxicillin (+) clavulanate potassium (Augmentin). The patient received her first dose of pneumococcal 23v polysaccharide vaccine and also received a yearly influenza vaccine in the left deltoid. The next day, on 26-Nov-2005, she noted some localized redness and warmth about the right deltoid, the site of the pneumococcal 23v polysaccharide vaccine. She was feeling worse as the day went on with pain and redness. She subsequently came into the emergency room for further evaluation and treatment. Upon arrival, her temperature was 38.8, pulse was 124, respirations were 20, blood pressure was 91/62, and her oxygen saturation was 100 percent on room air. It was determined that the patient had right arm cellulitis and that she would benefit from impatient IV antibiotics and care and was admitted to the hospital on 27-Nov-2005. In the afternoon of 27-Nov-2005, she was feeling much better. She was started on IV sultamicillin (Unasyn) 3 gm Q6 hours. In the emergency room she had received nalbuphine hydrochloride (Nubain) IM 10 mg once and promethazine hydrochloride (Phenergan) IM once. The patient noted having had nausea and vomiting on 26-Nov-2005 and earlier in the morning on 27-Nov-2005. She had no further nausea and emesis since the emergency room injection. The patient state that her arm felt a little sore about the right deltoid but not anything severe. She was quite pleased on how much better she felt in the afternoon of 27-Nov-2005 compared to earlier that day. The medical record noted that she started amoxicillin (+) clavulanate potassium (Augmentin) on 25-Nov-2005 and had two doses and just one dose on 26-Nov-2005 and none since because she was too nauseated in the evening to take the second dose. She had been taking guaifenesin 600 mg since approximately 25-Nov-2005 and was sporadically using hydrocodone syrup since approximately 25-Nov-2005. She had a nonproductive cough. In the afternoon of 27-Nov-2005, she appeared well, alert, and oriented. Respirations were unlabored, 16 per minute and her pulse was 84. She had some grayish-green nasal drainage and similar postnasal drainage. Her pharynx had mild injection. She had a very red, warm and somewhat swollen right deltoid area. There was a black pen marker approximately 4 by 6 inches drawn out at the border. Laboratory studies from the emergency room revealed and 12 percent bands. Hemoglobin was normal at 12.6. Blood cultures times 2 were drawn. The assessment was right deltoid arm cellulitis and upper respiratory infection/sinusitis. The plan was to continue with sultamicillin (Unasyn). A progress note from 28-Nov-2005, indicated that her right arm felt better and was less painful. She believed the redness was moving down her arm. She had a little nausea on and off. An assessment revealed that her right lateral deltoid area was erythematous and was essentially at the same location by the pen markings except that it had move down distally. It was just slightly warm. The erythema was a dark dull red. The assessment with right lateral deltoid cellulitis versus severe local immune skin reaction to pneumococcal 23v polysaccharide vaccine. It continued to improve. She did well and gradually recovered as an inpatient. She was discharged late in the afternoon on 28-Nov-200k with an order for levofloxacin (Levaquin) 750 mg PO every day for 10 days, promethazine hydrochloride (Phenergan) 25 mg PO Q6H prn for nausea and acetaminophen (+) oxycodone hydrochloride (Percocet) 1-2 tabs PO Q4H as needed for pain. It was noted that she was inadvertently given azithromycin (Zithromax) 750 mg IV when the order was for levofloxacin (Levaquin) 750 mg. She was to follow-up on 29-Nov-2005 with her family physician. Cellulitis was considered to be another important medical event by the reporter (OMIC). Other business partner numbers included E2005-05574.				Y	Y	2			Y	11/25/2005	11/28/2005	3		PVT	PVT	Augmentin, Nubain, Phenergan, Zithromax, Levaquin	Maxillary Sinusitis;Upper Respiratory Tract Infection	Otitis Media Acute;Hospitalization;Caesarean Section; Drug Hypersensitivity;Non-Smoker		WAES0512USA03242	1						1	Cellulitis; Erythema; Injection site hypersensitivity; Injection site warmth; Myalgia; Nausea; Pain; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~651319~7+~~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0251005	01/30/2006		60.0			F	01/20/2006	Information has been received from a physician concerning an approximately 60 year old female with type II diabetes mellitus who on approximately 11/07/2005 was vaccinated SQ with a dose of Pneumococcal 23v polysaccharide vaccine (lot #649914/0578P) and a dose of influenza virus vaccine (unspecified) into the opposite arm (unspecified). Concomitant therapy included an unspecified oral therapy. Subsequently the patient developed redness, pain and swelling to the arm that was used for the Pneumococcal 23v polysaccharide vaccination. Medical attention was sought and the patient received diphenhydramine hydrochloride (Benadryl) and prednisone. Subsequently, the patient recovered from redness, pain and swelling to the arm. The physician considered redness, pain and swelling to the arm to be other important medical events (OMIC). Additional information has been requested.				Y					Y	11/07/2005				OTH	OTH	Therapy unspecified		Type II diabetes mellitus.		WAES0601USA01525	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0578P~UNK~SC~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0251009	01/30/2006	MD	50.0	49		F	01/29/2006	Had flu shot, developed pain, swelling and fever. Pain shooting up my shoulder and neck.										11/18/2005	11/18/2005	0		PVT	OTH	Synthroid	NONE	Hypothyroidism			1						1	Injection site oedema; Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~U1914AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0251010	01/30/2006	GA	1.0	1	.0	F	01/30/2006	Scattered 3mm papular rash, DX Varicella, TX Acyclovir. Vaccine given 12/20/2004, reaction 12/04/2005.				Y					Y	12/20/2004	12/04/2005	349		PVT	PUB		Eczema	Aclovate cream			1						1	Drug ineffective; Rash papular; Viral infection	FLU3~SANOFI PASTEUR~U1437AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~C2114AB~1~~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0853P~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0646P~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0251012	01/30/2006	OH	1.31	1	.3	M	01/26/2006	Patient seen at office within 2 weeks after vaccination due to bump over body.  On exam patient had papular pap-lo-vesicular and umbilicated lesions on body.									Y	12/20/2005	01/03/2006	14		PVT	PUB		NONE	NO			1						1	Rash papular; Rash papular	FLU3~AVENTIS PASTEUR~U787GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|BCG~SANOFI PASTEUR~~UNK~~~BCG (MYCOBAX)~2|VARCEL~MERCK & CO. INC.~0419R~1~SC~~VARICELLA (VARIVAX)~2	USA		Influenza
0251013	01/30/2006	NC	49.0	48		F	01/24/2006	Patient received flu shot (1st flu vaccination) in left deltoid intramuscularly on 01/10/2006.  Later that day, experienced swelling in bicep with tenderness.  Left axillary node tenderness/swelling.  Symptoms resolved, but does have occasional sharp pain and tenderness.				Y					Y	01/10/2006	01/10/2006	0		PUB	PUB	HCTZ, Norvasc, Potassium	NO	Hypertension			1						1	Pain; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U1914AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0251014	01/30/2006	MD	62.0	61		F	01/26/2006	Postural vertigo - unable to lie down flat on back or rise to sitting position without experiencing vertigo and some nausea which continues 1-20 through 1-26 (has not ceased).									N	01/19/2006	01/20/2006	1	NONE	OTH	OTH	Lipitor, synthroid, baby aspirin, prevacid, vitamins, glucosamide	NONE	Arthritis, high cholesterol			1						1	Vertigo	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA132BA~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0251060	01/30/2006	NY	27.0	27		M	01/30/2006	Influenza vaccine, Lot #U1747AA, 0.5cc administered I.M. to R Deltoid at approx. 3:35pm on 1/27/06.  Had pt wait x 15 min (1st time receiving flu vaccine).  At 3:45pm, pt was standing, leaning against wall and appeared distressed (staring straight ahead, furrowed brow) and via interpreter pt c/o sensation of lips swelling and throat closing, and mild difficulty breathing. Pt's skin warm to touch, had hand tremors, but no diaphoresis and no rash or c/o itching.  Pt was given 3 tsp (15cc) of liquid diphenhydramine HCl (12.5mg/5cc)at this time and was moved to a sitting position.  At 3:50pm condition was no better, and per interpreter, sensation of throat closing was slightly worse. Pulse=64 BPM,Reg Rate, BP 124/84. 0.3 ml of Epinepherine 1:1,000 was given S.C. in L arm at this time. At 4:00pm, pt clutched chest and throat, was gasping for breath, tears rolling down face.  He was lowered to lying position on floor and 911 was called.  BP was 110/82, pulse 82, lungs auscultated from front only-no wheezing heard, no rash or hives or c/o itching. One more tsp. of diphenhydramine was given. Pt breathing eased with movement to lying position, he remained alert, anxious,skin, warm and dry (though shivering), stated tightness in throat was no worse, but no better. Pt was covered with blankets and EMS arrived within 5 minutes, administered Oxygen via face mask and pt was transported to E.R. with interpreter for further eval. Per the pt's employer, he was felt to be recovered and was released at about 8:00 pm that evening.				Y					Y	01/27/2006	01/27/2006	0	Blood Glucose at EMS arrival=133 O2 saturation was high 90%	UNK	UNK	None	None	None			1						1	Anxiety; Dyspnoea; Face oedema; Hypoxia; Lacrimation increased; Pharyngeal oedema; Skin warm; Staring; Throat tightness; Tremor	FLU3~SANOFI PASTEUR~U1747AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0251073	01/31/2006	MN	69.0	68		M	01/27/2006	Fever, chills, temp, headache, dry cough, anorexia, weight loss.				Y					Y	10/20/2005	10/24/2005	4	NONE	PVT	PVT		Viral upper respiratory	NONE			1						1	Anorexia; Chills; Cough; Headache; Pyrexia; Weight decreased	FLU3~SANOFI PASTEUR~U1832BA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0706P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0251075	01/31/2006	VA	4.0	4		M	01/26/2006	Mild swelling of right thigh at injection site (MMR). Seen by DR. Benadryl 125/5 1tsp PO given and Tylenol 240mg PO given at 11:25, mild redness and swelling left thigh inj site.									Y	01/26/2006	01/26/2006	0	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Injection site hypersensitivity; Injection site oedema; Injection site reaction	DTAP~SMITHKLINE BEECHAM~AC14B002BA~5~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1914AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y03262~5~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1056R~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0251076	01/31/2006	KY	1.11	1	.1	F	01/06/2006	Pt had measles rash 10 days after vaccine administered. PCP told mom that child had measles from vaccine.									Y	12/01/2005	12/11/2005	10	NONE	UNK	UNK		NONE			TN05072	1						1	Rash morbilliform; Viral infection	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A019AA~4~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1787AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0347R~3~IM~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0152R~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A98339E~1~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0426R~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0251117	01/31/2006	PA	1.28	1	.3	M	01/31/2006	Had MMR given along with Prevnar and flu vaccine (NOS on 10/15/2005). Office visit: 11/1/05 C/O runny nose 1 weep rash 3>2 days, fever on 2 week									Y	10/15/2005			Rubella- IgG 1.84 increase;Rubella IgM 3.592 increase.	PVT	PUB	Motrin	NONE	NONE			1						1	Laboratory test abnormal; Pyrexia; Rash; Rhinorrhoea	FLU3~SANOFI PASTEUR~U1863AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0031R~UNK~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A9834D~UNK~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0251118	01/31/2006	NJ	0.77	0	.8	F	01/31/2006	10/26/05 9:30pm Mother called stating daughter had flu shot today. Now c/o eyes red and swollen, skin is slightly blotchy. Mother feels child is having allergic reaction to vaccine. Benadryl given. 10/27/05 10:30 am Mother called back, states child is much better. Subsequent immunocap allergy testing plus egg white allergy.									Y	10/26/2005	10/26/2005	0	Childhood Allergy Profile plus egg white allergy	PVT	PVT		NONE	NONE			1						1	Erythema; Eye swelling; Hypersensitivity; Rash macular; Skin disorder	FLU3~SANOFI PASTEUR~U1787CA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0251125	02/01/2006	TX	77.0	77		F	01/26/2006	Initial report received on 11/3/2005 from a consumer. A 77 year old female patient who was currently taking Zestoretic, Toprol XL, 200 mg, Tricor, 160 mg and Synthroid 0.1mg at the time of the vaccination had received an administration (route site not reported) of Fluzone SV 2005-2006 USP lot number not reported on 9/21/2005. The next day she complained of muscle soreness, weakness and joint pain. The patient fells it is very severe in nature. She was evaluated by a physician and was prescribed methylprednisolone which slightly improved her conditions. The patient had some unspecified diagnostic testing completed to rule out rheumatoid arthritis. The patient had not recovered from these events at the time of the report. Follow up information received on 1/13/2006 from the patient. Per the reporter, the patient stated she developed muscle weakness and soreness the day after receiving an intramuscular injection of Fluzone SV 2005-2006 USP, lot number U1806AA, in the left deltoid on 9/21/2005 at 15:30. After seeing three doctors she was diagnosed with polymyalgia rheumatica. The patient was taking Norvasc at the time of the vaccination. It is unknown if the patient recovered from these events at the time of this report. Follow up information received on 1/24/2006 from the patient. The patient reported that the day after receiving an injection of Fluzone, she woke up aching like she had the flu. She traveled and a pre planned trip from 10/13/2005 to 10/20/2005 and reported that she was in great pain and could not sleep at night. She was seen by a physician who prescribed Advil, which did not improve her symptoms. She reported that she had to be assisted out of chairs, the bus, etc. and that by the time she returned home she was home bound until she saw a rheumatologist and received the diagnosis of poly myalgia rheumatica. She reports that she is now taking prednisone and had had to add Norvasc to control her high blood pressure. It was not reported whether she has recovered from the events. Due to the new information provided on 1/24/2006, this case is being upgraded to serious (OMIC).				Y					U	09/21/2005	09/22/2005	1		OTH	PVT	Toprol XL, Zestoretic, Tricor, Synthroid, Norvasc,				200502337	1						1	Arthralgia; Asthenia; Hypertension; Hypokinesia; Influenza like illness; Insomnia; Muscular weakness; Myalgia; Pain; Polymyalgia rheumatica	FLU3~SANOFI PASTEUR~U1806AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0251131	02/01/2006	NE	1.33	1	.3	M	01/27/2006	Information has been received from a registered nurse concerning a 16 month old male  with a history of osteomyelitis in the left leg who on 11/18/2005 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (lot # 646669/0626R). Concomitant vaccination that day included a third dose of Hib conj hepatitis B vaccine (lot 652710/0695R) given IM in the right thigh and a first dose of influenza virus split virion 3v vaccine inactivated (Fluzone) given IM in the left thigh. Illness at the time of vaccination was resolved OM. On 11/30/2005 the patients mother noted a marble size lump at the varicella virus vaccine live  injection site and a  swollen gland in his groin. The child was seen by the physician on 12/02/2005 with induration and redness at the injection site. The patient was treated with cephalexin (Keflex). At the time of the report the patient was recovering. There was no product quality complaint involved. Follow up information indicated that on 11/30/2005 the patient developed a lump at the injection site and swollen lymph node in the right groin without redness. On 12/01/2005 the lump at the injection site was red. On 12/02/2005 the patient had a 1x1 cm area of erythema with papule and 2-3 cm long x 1-2 cm wide induration and inguinal adenopathy. The patient had no temperature and was  treated with Keflex 250 TID x 10 days. No work up was done. On approximately 12/12/2005 the patient recovered. The patients events were considered to be other important medical events (OMIC). No further information is expected.				Y					Y	11/18/2005	11/30/2005	12		PVT	PVT		Otitis media	Osteomyelitis		WAES0512USA00224	1						1	Injection site erythema; Injection site hypersensitivity; Injection site induration; Injection site oedema; Injection site reaction; Lymphadenopathy; Rash papular	FLU3~SANOFI PASTEUR~U17658A~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0695R~3~IM~RL~HIB + HEP B (COMVAX)~1|VARCEL~MERCK & CO. INC.~0626R~UNK~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0251134	02/01/2006	OR	32.0	32		M	01/24/2006	12/17/2005 1st signs of nerve damage, 12/19/05 Dr visit no diagnosis, 12/21/05 Dr visit referred to neurologist, 12/22/05 Neurologist diagnosed GBS, 12/23/05 EMG Spinal Tap confirmed Guillain Barre Syndrome, 01/24/06 partially recovered. Information from medical records includes paresthesis, decreased reflexes, ataxia. msv			Y	Y					U	11/07/2005	12/17/2005	40	Proteins in spine were high, EMG showed nerve damage.  Information from medical records includes abnormal lab tests. msv	PVT	PVT			Acid reflux			1						1	CSF test abnormal; Coordination abnormal; Guillain-Barre syndrome; Hyporeflexia; Laboratory test abnormal; Nerve injury; Paraesthesia	FLU3~SANOFI PASTEUR~U1905AA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0251136	02/01/2006	SC	57.0	57		F	01/31/2006	Flu shot caused a local panniculitis that lasted more than 1 year and required surgical excision of inflamed necrotic fat to finally cure.				Y					Y	12/02/2004			1/12/05 pathology report fat necrosis with acute inflammation.	PVT	PVT		NONE	psoriasis			1						1	Panniculitis; Skin necrosis; Toxic epidermal necrolysis	FLU3~SANOFI PASTEUR~U1555AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0251150	02/01/2006	MI	58.0	58		M	02/01/2006	Symptoms began next day-initially aching and stiffness in neck and shoulders.  Following day began feeling weakness and unsteadiness in legs, and tingling and numbness in hands.  Worsened over 3-4 week period.  12/7/05 app't with internist.  He set up spinal MRI, blood tests, and appointment with neurologist.  1/2/06 app't with neurologist.  Diagnosis post vaccinial transverse myelitis.  He set up brain MRI and lumbar puncture procedure, as well as a 12 day program of interveinous and oral steroids. Information from medical records state abnormal gait.msv Follow-up: Transverse myelitis. No improvement.								Y	N	11/08/2005	11/09/2005	1	spinal mri-transverse myelitis. blood work-normal brain mri-normal (no MS) lumbar puncture-normal (no MS) Information from medical records states abnormal lab reports. msv	UNK	UNK	combivent	none	none			1						1	Balance disorder; Blood test normal; Gait disturbance; Hypoaesthesia; Lumbar puncture normal; Muscular weakness; Musculoskeletal stiffness; Myelitis transverse; Nuclear magnetic resonance imaging brain normal; Nuclear magnetic resonance imaging spinal cord abnormal; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~u1910aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0251169	02/02/2006	CT	52.0	51		F	01/30/2006	Client reports constricting feeling in chest, cough becoming productive, difficulty breathing and those symptoms lasted through PM. Client went to bed. Awoke next morning with face/eyes swollen - these symptoms lasted through next day. Entire event lasted approximately 24 hours. Client did not seek any treatment.									Y	11/15/2005	11/15/2005	0	NONE	PUB	UNK		NONE	NONE			1						1	Chest discomfort; Dyspnoea; Face oedema; Periorbital oedema	FLU3~SANOFI PASTEUR~U1916AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0251170	02/02/2006	NJ	4.0	3		F	01/19/2006	Within 1-2 hours of vaccine, pt became lethargic and difficult to arouse. Vomited once.				Y					Y	01/18/2006	01/18/2006	0	Urine drug screen, tox screen; Head CT; All results negative; Done in ER	OTH	PUB	NONE	NONE	Asthma		NJ200601	1						1	Depressed level of consciousness; Lethargy; Vomiting	FLU3~SANOFI PASTEUR~U1867DA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0251171	02/02/2006	VA	0.96	0	1	M		PC from PGM states infant with big knot in leg. Saw PMD - referred to surgeon. Had I and D of abscess per PGM 1/2 inch wide 1 inch in depth that is patched daily and placed on 10 days of antibiotics. To follow-up with surgeon. 1/05/2006 C and S done. See MD notes (attached). Abscess left thigh - I & D on 12/28/2005. Culture Staph A, susceptible to Bactrim.									Y	12/19/2005	12/21/2005	2		PUB	PUB		NONE	NONE			1						1	Injection site abscess	FLU3~SANOFI PASTEUR~U1765EA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0251174	02/02/2006	IA	5.0	5		F	02/02/2006	Child had 6 cm. rash on right deltoid area and hives on trunk of body.				Y					Y	01/31/2006	02/01/2006	1		UNK	UNK		NA	NA			1						1	Rash; Urticaria	DTAP~SANOFI PASTEUR~C2405AA~5~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1866AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0488R~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0251178	02/02/2006	CO		0	.0	M	02/02/2006	Pt reported numbness down arm from site of flu injection. This occurred 3 weeks following administration of immunization.									U	11/01/2005	11/21/2005	20		UNK	UNK						1						1	Hypoaesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~150AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0251200	02/03/2006	MI	68.0	68		F	01/31/2006	Initial report received from the patient on 1/24/2006. The 68 year old female patient with a medical history of glaucoma, had received an injection of Fluzone SV 2005-2006 USP, lot number not reported, in the left deltoid on 11/01/2005. One day later, her face swelled up and she developed red blotches on her face. Her eyes were red and swollen. She also developed a sore between her eyes, which became painful and itchy. She was seen by her eye specialist two to three weeks later and was treated with Benadryl and steroids. The patient reported that she now has a deep scar between her eyes and cannot wear glasses because of her puffed eyes. She has not recovered from these events.				Y					N	11/01/2005	11/02/2005	1		PVT	UNK			The patient has a history of glaucoma. She had previously received one dose of influenza vaccine.		200600163	1						1	Erythema; Eye disorder; Eye swelling; Face oedema; Ocular hyperaemia; Pain; Pruritus; Rash macular	FLU3~SANOFI PASTEUR~~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0251204	02/03/2006	MA	54.0	54		F	01/30/2006	Eyes became itchy 1 1/2-2 hours after flu shot.  During night yellow discharge from eyes and puffy lids. Eyelashes were stuck together. This lasted for about 24 hours.									Y	10/31/2005	10/31/2005	0	Normal temp, blood pressure, heart rate, etc.	OTH	PUB	NONE	NONE	NONE			1						1	Eye discharge; Eye inflammation; Eye irritation	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0251213	02/03/2006	MN	49.0	49		F	02/03/2006	R arm pain and swelling post flu and pnemovax injections warm to touch. Sx noted after 24 hrs of injections- local reaction.									U	02/01/2006	02/02/2006	1	local reaction	UNK	UNK	tetracycline 250mg caps bid for acne, temazepam 15mg caps 1 cap q hs,prn, tretinoin 0.05% cr for acne, avelox 400 mg tab 1 tab qd, minocycline 50 mg caps 1 cap qd for acne	non	Depression, acne, allergy to septra, allergy to lexapro.			1						1	Injection site warmth; Pain; Swelling	FLU3~SANOFI PASTEUR~U1915AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0886R~1~IM~LA~HEP A (VAQTA)~1|PPV~MERCK & CO. INC.~0741R~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0251221	02/03/2006	OH	43.0	43		F	02/04/2006	10/19 begin to feel bad, 10/21 high fever will not come down even with Tylenol or Advil,  10/24 ER chest X ray diagnosed with pneumonia, 10/25 Dr appt to check medication, 10/29 noticed weakness in legs beginning in morning balance problems and weakness worsen, 10/30, ambulance to ER, 11/02 spinal tap clear symptoms paralysis, foot drop, muscle spasms, inflamed nerve endings in legs and feet, 11/04 transferred to another hospital, 11/04 extremely high protein level in blood due to deterioration of muscles. Start on baclofen to stop spasms, 11/09 protein level back to normal, 11/11 transferred to rehab Unit cannot walk at all, 11/14-22 physical therapy 4 times a day for 45 minutes. Learn to walk again, balance problems, diagnosed with Post infectious myositis, released 11/22 on going therapy to improve function. 11/25 begin outpatient therapy 3 times a week on going due to peroneal nerve damage in feet. I have peroneal neuropathy- foot drop due to flu vacine. Swelling of feet and ankles, pain in feet, decreased movement, no feeling in toes ore feet. Still go to physicial therapy to regain strength and flexability. Constatn muscle spasms in feet. Nerve damage from ankles down. 3/31/2010 Follow up: No feeling in feet and legs due to damage to peroneal nerve. Loss of movement in ankles/swelling in feet neurological problems-short term memory loss, difficulty in concentration and difficulty finding words and thoughts.			Y	Y	Y	24	Y		N	10/15/2005	10/21/2005	6	Spinal tap (2) clear, EMG (2) never damage to peroneal nerve.  Information received from discharge summary states CPK increased, lab tests abnormal, from Medical records, sed rate increased. msv	OTH	PVT	NONE		Sulfa Allergy;Mitral Valve Prolapse			1						1	Abasia; Amnesia; Balance disorder; Blood creatine phosphokinase increased; Chest X-ray abnormal; Disturbance in attention; Electromyogram abnormal; Feeling abnormal; Hypoaesthesia; Hypokinesia; Infective myositis; Joint swelling; Laboratory test abnormal; Lack of spontaneous speech; Lumbar puncture normal; Muscle atrophy; Muscle spasms; Muscular weakness; Nerve injury; Neuropathy; Neuropathy peripheral; Oedema peripheral; Pain in extremity; Paralysis; Peroneal nerve palsy; Pneumonia; Protein total increased; Pyrexia; Red blood cell sedimentation rate increased	FLU3~SANOFI PASTEUR~U1793AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0251222	02/03/2006	NY	17.0	16		M	02/02/2006	Patient reportedly developed tiny, confluent fine raised rash on face-cheeks and forehead and at site of flu injection-upper L arm.  Non-erythematous, non-puritic, denies itching, difficulty breathing, swelling, hoarseness, wheezing, dizziness or fast heart rate.  Occurs 2 days after fluzone administration.									Y	01/30/2006	02/01/2006	2		OTH	PUB	NONE					1						1	Injection site swelling; Rash; Rash erythematous	FLU3~SANOFI PASTEUR~U1914AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0251218	02/04/2006	IN	1.51	1	.5	F	02/03/2006	1/2 dose flu shot on 11/10/05.  2nd 1/2 dose (same lot and exp) on 12/6/05.  Febrile 2/2/06 and Flu A test positive on 2-3-06 (rapid nasopharyngeal swab).				Y					Y	12/06/2005	02/02/2006	58	Rapid nasopharyngeal swab flu A/flu b/ RSV, with flu A positive.	UNK	UNK	11-18-05, Zithromax (100mg/5ml) 4.5 ml po on day 1, 2.25 ml po on days 2-5. (failure of Amoxicillin (250 mg/5ml) 5ml po tid for 10 days, therapy given 10-26-05).	Bilateral Acute otitis media.	Short stature/poor weight gain			1						1	Drug ineffective; Viral infection	FLU3~SANOFI PASTEUR~U1863AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0251244	02/06/2006	MD	38.0	38		F	02/02/2006	Initial report received on 1/30/2006 from the patients parent. A 38 year old female patient with a history of pericarditis and insulin dependent diabetes had received an administration (route not reported) of Fluzone SV 2005-2006 USP lot number not reported, in the left arm, and an administration route not reported, of another manufacturers Pneumovax 23 vaccine, lot number not reported in the left arm on 11/03/2005. that same day the patient developed chest and shoulder pain. the patient was uncomfortable for three weeks and on 12/16/2005 she began to experienced shortness of breath. The chest pain became more severe on 12/28/2005 and the patient was seen in the ER. per the reporter, the patient had high ketoacidosis, WBC and a 0.38 cardiac enzyme. An Echo, EKG and cat scan was completed (date and results not reported). At the time of this report the patient had not recovered from these events. - Per review of medical records on 4/13/06 the diagnoses were hyperglycemia, dyspnea, and elevated troponin (0.38). Leukocytosis was later noted and was thought to be secondary to the elevated blood glucose. Admission list of diagnoses included diabetic ketoacidosis, possible sinusitis, hypothyroidism, shortness of breath (likely secondary to metabolic acidosis), and history of tobacco abuse (down to 1 PPD from 2PPD). Malaise and periorbital swelling were noted on PE. 4/13/06 Review of medical records for 3/23/06 overnight ER admission indicates discharge diagnoses of fever, abdominal pain, and chest pain.  Per 60 day follow up recipient has not recovered yet has elevated white blood count, fevers of 100.1-100.6 and shortness of breath episodes.  Follow-up: High white blood count. Elevated neutrophils. Low grade fever. Burning in chest area. All since 11-3-05.				Y	Y	1			N	11/03/2005	11/03/2005	0	Per review of medical records on 4/13/06, chest CT with IV contrast was negative. Abdominal CT and pelvic CT were negative. WBC was 28.2 then 12.7. Urinary protein was 25 and blood glucose was 452 then 107. There was no sign of pulmonary embolism. D Dimer was 336 (norm 0-200). Blood culture showed no growth at 5 days.	UNK	UNK	Cozaar;Levoxyl;Lantus		Per the reporter, the patient had no illnesses at the time of the vaccination. The patient had a history of pericarditis and insulin dependent diabetes. She was taking Cozaar, Levoxyl and Lantus at the time of the vaccination.		200600225	1						1	Abdominal pain; Blood culture negative; Blood glucose increased; Cardiac enzymes increased; Chest pain; Chest pain; Computerised tomogram; Computerised tomogram abdomen normal; Computerised tomogram normal; Diabetic ketoacidosis; Discomfort; Dyspnoea; Dyspnoea; Echocardiogram; Electrocardiogram; Eye swelling; Fibrin D dimer normal; Hyperglycaemia; Leukocytosis; Malaise; Metabolic acidosis; Neutrophil count increased; Protein urine present; Pyrexia; Shoulder pain; Troponin I increased; White blood cell count increased; Asthma; Bacterial infection; Chest pain; Dyspnoea; Enzyme abnormality; Hypokinesia; Nausea; Pain; Pyrexia; Vomiting; White blood cell count increased	FLU3~SANOFI PASTEUR~U1863AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0529D~UNK~~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U1863AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0529D~UNK~~~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0251246	02/06/2006	NH	29.0	28		F	01/31/2006	On 1/12/06 client reported she experienced numbness and tingling in her hands and feet. This progressed to difficulty with ambulation and inability to use her facial muscles. She was diagnosed with GBS and hospitalized on 01/22/2006. Client was 22 weeks pregnant on 01/12/2006. Client also reported she was ill with cold symptoms prior to onset. Discharge DX Guillain Barr syndrome resolving. Information from Discharge summary states incontinence of urine. msv				Y	Y	8			Y	11/19/2005	01/12/2006	54	From Discharge summary add hypokalemia. msv	PUB	PUB	NONE		Allergy to cats From Discharge summary information adds pregnancey to Hx. msv			1						1	Difficulty in walking; Facial palsy; Guillain-Barre syndrome; Hypoaesthesia; Hypokalaemia; Malaise; Paraesthesia; Pharyngitis; Rhinitis; Urinary incontinence	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA120AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0251247	02/06/2006	NC	30.0	30		F	02/05/2006	Raised redness 7 cm in diameter, itching, no fever. Received flu shot on 4Feb06 around 14:00, symptoms started around 18:00 on 4Feb06									U	02/04/2006	02/04/2006	0		MIL	MIL		NONE	Sulfa;Phenergan;Dencrol			1						1	Pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~U1869AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0251248	02/06/2006	CA				F		A female child was vaccinated with Flumist, intra-nasally on 20 Jan 2006 for influenza.  After receiving Flumist the child complained to the school nurse about not feeling well.  The school nurse examined the child and sent the child back to class.  No specific symptoms were noted at that time.  On the evening of 20 Jan 2006, approximately 8 hours after vaccine administration, the parents took the child to the ER due to facial edema.  It was not reported whether or not treatment was received for the symptoms.  The child returned to school on 23 Jan 2006.									U	01/20/2006	01/20/2006	0		PUB	PUB	Concomitant Drugs not reported				MEDI0004076	1						1	Face oedema; Malaise	FLUN3~MEDIMMUNE VACCINES, INC.~50039~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0251258	02/06/2006	VA	82.0			F	02/06/2006	Left Deltoid. Arm was very sore and hard to move. Area where vaccine administered was size of a grapefruit according to home nurse.  Area was bruised and remained bruised at the 10 day mark.  Pt was seen by her PCP who stated it was fine and no treatment needed.  Area resolved itself.  Pt stated was not on coumadin.				Y					Y	10/08/2005				UNK	UNK						1						1	Contusion; Hypokinesia; Pain	FLU3~SANOFI PASTEUR~u1764aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0251269	02/07/2006	GA	1.01	1	.0	F	02/06/2006	About 12 lesions, trunk mostly.  One on head.  Diagnosis: Varicella  Treatment: Symptomatic				Y					Y	11/14/2005	12/04/2005	20	NONE	PVT	PUB	PPD 2181AA RA, NONE	NONE	NONE			1						1	Skin ulcer; Viral infection	FLU3~SANOFI PASTEUR~U1804AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0602R~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0627R~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0251274	02/07/2006	GA	1.01	1	.0	M	02/01/2006	Information has been received from a physician concerning a 12 month old male with an allergy to amoxicillin (+) clavulanate potassium (Augmentin) who on 21-Oct-2005 was vaccinated in the right thigh with a first dose of varicella virus vaccine live. Concomitant vaccinations administered that day included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live, a dose of influenza virus split virion 3v vaccine inactivated (Fluzone), and a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar). There was no illness at the time of vaccination. Subsequently, the patient developed a small amount of lesions on the body and a fever elevated to 105 degrees Fahrenheit. The patient was taken to the hospital and administered antibiotics. Laboratory studies were performed (results not provided). The patient subsequently recovered. It was noted that it was not known what vaccine caused the events. A product quality complaint was not involved. Follow-up information from the physician indicated that on 01-Nov-2005 papulopustular lesions developed around the injection site. The patient's fever started three days ago, on 04-Nov-2005. It was to 102 F. The patient also had gunky eyes. On 04-Nov-2005 and 05-Nov-2005 the patient's temperature was at 103.5 F. On 06-Nov-2005 the patient's fever was 105.2 F. He was then sent to the emergency room and started on azithromycin (Zithromax). It was noted that the patient was on therapy with cetirizine hydrochloride (Zyrtec). Laboratory test were performed, abnormal results were as follows: C reactive protein was 12.4 mg/dl (high), white blood cell count was 20.7 (high), red blood cell count was 3.79 (low), hemoglobin was 10.2 (low), hematocrit was 29.8 (low), and RDW was 15.6 (high). A strep scream was negative. On 07-Nov-2005 the patient was seen in the physician's office. He had a cluster of lesions at the injection site of the vaccine on the right thigh x 1 week, and one pustule on neck x several days. Upon exam the patient had thrush on the buccal mucosa (both sides) and on the left tonsil. It was noted that he had been on amoxicillin (+) clavulanate potassium (Augmentin) since 28-Oct-2005. The physical examination showed that his nose/sinus, mouth/teeth, throat and skin were abnormal. Assessment of the patient indicated fever, vaccine -type varicella and thrush. The plan from the physician included reassurance, flu for fever > 5 days, and nystatin. There was no mention of hospitalization. The patient's adverse events were determined to be other important medical events by the physician (OMIC). Additional information is not expected.				Y					Y	10/21/2005	11/01/2005	11	Physical examination 11/07/05 - Abnormal nose/sinus, mouth/teeth, throat, skin. 11/06/05 Streptococcus negative 11/06/05 Hemoglobin 10.2 g/dl low-normal range 10.5-14.0 11/07/05 Body height measurement 81.5 cm - 32 in 11/06/05 Body temp 105.2 F fever 11/06/05 RDW 15.6% high - normal range 11.5-14.0 11/07/05 RI 40 11/07/05 Total heartbeat count 128 11/06/05 Hematocrit 29.8% low - normal range 32.0-42.0 11/06/05 WBC count 20.7 high - normal range 6.0-14.0 11/06/05 Serum C-reactive 12.4 mg/d high - normal range 0-0.5 11/06/05 RDW 29.8% low - normal range 32.0-42.0 low 11/06/05 Red blood cell count 3.79 low - normal range 3.80-5.40 11/04/05 Body temp 102 F fever 11/05/05 Body temp 103.5 F fever 11/07/05 Body weight measurement 11.7 kg  25.6 lb	PVT	PVT	UNK		Allergic reaction to antibiotics		WAES0511USA00930	1						1	Blood gases abnormal; Candidiasis; Dermatitis bullous; Eye discharge; Haematocrit decreased; Haemoglobin decreased; Injection site reaction; Laboratory test abnormal; Pyrexia; White blood cell count increased; Candidiasis; Eye discharge; Haematocrit decreased; Haemoglobin decreased; Hypersensitivity; Injection site reaction; Laboratory test abnormal; Pyrexia; Rash papular; Rash pustular; Skin disorder; Skin ulcer; Viral infection; White blood cell count increased	FLU3~SANOFI PASTEUR~~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~~UNK~~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~~UNK~~UN~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~~UNK~~UN~VARICELLA (VARIVAX)~1|FLU3~SANOFI PASTEUR~~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|MMR~MERCK & CO. INC.~~UNK~~UN~MEASLES + MUMPS + RUBELLA (MMR II)~2|PNC~PFIZER\WYETH~~UNK~~UN~PNEUMO (PREVNAR)~2|VARCEL~MERCK & CO. INC.~~UNK~~RL~VARICELLA (VARIVAX)~2	USA	Emergency room visit	Influenza
0251307	02/07/2006	WA	38.0	38		F	02/07/2006	Patient states that about 12 hours after receiving vaccine she began feeling ill with swollen glands in neck, fatigue, muscle aches, and fever.  States she felt perfectly healthy prior to vaccine, and when she returned to relate this information two and a half days after receiving vaccine she said she still felt ill.									U	11/17/2005	11/17/2005	0	Received PPD test (Tubersol, 5TU) at same time as the below listed vaccine, on left forearm intradermally.  PPD was read as negative (0 mm) on 11/9/05, the date she reported the adverse event.	UNK	UNK		No	States she had allergies to Penicillin and Keflex; denied any chronic or long-term health problems or conditions at time of vaccine. Stated she had received injectable flu vaccine in past without difficulty.			1						1	Fatigue; Lymphadenopathy; Malaise; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1905AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0251311	02/08/2006	FL	5.0	5		F	02/03/2006	As soon as the I/M vaccine was administered-within 1-2 seconds Pt became tense and went into a generalized tonic seizure lasting about 3.5 minutes.  Pt vital signs remained stable.  She was post icteal after treatment.  She was sent to ER via paramedics.				Y					Y	02/02/2006	02/02/2006	0	Seen at ER.  Head CT, CBC, BMP and exam were normal.	PVT	UNK			Prematurity, otitis media, BMT x3			1						1	Convulsion; Postictal state	FLUX~UNKNOWN MANUFACTURER~61321~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0251342	02/09/2006	NH	50.0	49		F	02/06/2006	Sore throat, swelling within 2 days of Flumist, persisted for weeks,then tinnitus.  Still having URI symptoms 1 month after Flumist.				Y					N	01/04/2006	01/06/2006	2	Normal CBC, negative throat culture	PVT	UNK		NONE	Sulfa, compuzine allergies, history migraine headache, hypothyroid			1						1	Pharyngolaryngeal pain; Swelling; Tinnitus	FLUN3~MEDIMMUNE VACCINES, INC.~500390P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0251347	02/09/2006	WI	36.0	36		M		Dry cough.  A little chest tightness. states physician.  Friend told him he had Oculo-Respiratory Syndrome-an adverse event found after Canadian flu vaccine.									Y	11/02/2005	11/02/2005	0	NONE	OTH	PVT		NONE	NONE			1						1	Acute respiratory distress syndrome; Chest discomfort; Cough	FLU3~SANOFI PASTEUR~U1744AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0251349	02/09/2006	MI	31.0	30		F	01/15/2006	Swollen area left arm 5 diameter. Blisters itching, redness.  No bleeding. Treatment-Z Pack, Medrol dose pack									Y	01/03/2006	01/03/2006	0		PUB	PVT		NONE	Penicillin			1						1	Blister; Erythema; Pruritus; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62759~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0251350	02/09/2006	CA				U	01/31/2006	Cellulitis around injection site.										01/11/2006	01/31/2006	20		UNK	UNK						1						1	Cellulitis; Injection site reaction	FLU3~SANOFI PASTEUR~U1832BA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1049P~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0251363	02/09/2006		1.19	1	.2	M		A report was received from a healthcare professional on 12/19/2005, regarding a 13 month old male vaccinee. No details were provided regarding the vaccinees medical history or concomitant medications. On 10/21/2005, the vaccinee received 0.25 ml of influenza vaccine. On 12/9/2005, the vaccinee received 0.25 ml of Fluvirin intramuscularly in the leg. On 12/11/2005, it was noted that the vaccinee was not bearing any weight on the leg that received the vaccination. No localized redness at injection site was reported. At the time of reporting the adverse event was continuing. Follow up information received on 2/1/2006: the vaccinee had no relevant past medical history and was receiving no concomitant medications. The vaccinee was diagnosed with transient synovitis in the left hip, hip pain and a fever. Onset of symptoms was within twenty four hours of receiving Fluvirin. X ray of the left hip and lower leg were negative and blood cultures and biochemistry were all within normal limits. The vaccinee was treated with Motrin (Ibuprofen). All symptoms were resolved within four weeks of vaccination.								Y	Y	12/09/2005	12/10/2005	1		UNK	UNK	NONE				CVOX200500258	1						1	Abdominal pain; Hypokinesia; Medication error; Pyrexia; Synovitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~51128~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0251368	02/09/2006	OH	2.0	2	.5	F	02/08/2006	On 2/6/06 Mom in clinic c/o child had rash, hives, itching on Saturday. 2/4/06 Mom treated with 2.5 HIC cream ? on 2/4/06. Macular erythematous, lesions on face. Mom reports was on back and legs. ?  temp. Denies new foods cream soups, detergent ?. No urticaria. Will see tomorrow.									Y	01/26/2006	02/04/2006	9		PUB	PUB		NONE	NONE			1						1	Erythema; Pruritus; Rash macular; Skin ulcer; Urticaria	DTAP~SANOFI PASTEUR~U1396BA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1872AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0935R~3~IM~LL~HIB + HEP B (COMVAX)~1|IPV~SANOFI PASTEUR~Y0575~3~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~B08635A~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0251375	02/10/2006		25.0	25		F	02/07/2006	Information has been received from a nurse practitioner concerning a 25 year old female inpatient with obesity, other unspecified conditions, latex allergy, morphine allergy, and multiple other medication allergies, who on 12/28/2005 was vaccinated subcutaneously in the left arm with a dose of Pneumococcal 23v polysaccharide vaccine (lot unknown) and influenza virus vaccine (unspecified), prior to discharge from the hospital. Patient was in the hospital for an unspecified reason. Nurse reported that the patient was obese and the vaccination was given subcutaneously because the needle was not long enough. Shortly after vaccination, on 12/28/2005, the patient developed injection site itching, chills, shaking and fever of 39.2 degrees C. After discharge, on 1/3/2006, she was seen at the clinic with a 5cm x 3 cm blister. The blister was opened and now the patient has an open wound and big hole. The wound is being packed daily and the patient has received cephalexin (Keflex) and pain pills (unspecified). The patients present status was reported as not recovered. No product quality complaint was involved. Injection site itching, chills, shaking, fever of 39.2 degree C and blister 5cm x 3cm were considered to be disabling and an other important medical event (OMIC). Additional information has been requested.				Y				Y	N	12/28/2005	12/28/2005	0	Body temp 12/28/2005 39.2 Degrees.	OTH	OTH			Obesity, general symptom, latex allergy, drug hypersensitivity, multiple allergies, hospitalization.		WAES0602USA00417	1						1	Chills; Injection site hypersensitivity; Injection site vesicles; Pruritus; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0251381	02/10/2006	MD	61.0			F	02/08/2006	Initial report received on 1/27/2006 from an investigator participating in the above mentioned trial under the reference number FID02. A 61 year old female subject received an intradermal injection of either study article influenza virus vaccine USP trival A and B high dose, Subvirion U or study article influenza virus vaccine USP trival A and B Subvirion U on 9/27/2005. On that day she developed redness at the injection site which resolved over the next nine days. Twenty one days post vaccination, she had no complaints and was administered an intramuscular injection of Fluzone SV 2005-2006, lot number not reported. Approximately ten days following that vaccination, she was hospitalized with neurological complaints and diagnosed with transverse myelitis. A MRI showed subtle findings in the spinal cord. She was treated with steroids and fully recovered. Per the reporter, the subject is now (date not reported) readmitted with an exacerbation of the disease, and the neurologist believes this is a form of acute disseminated encephalomyelitis. The MRI findings are extensive in the posterior cord although her clinical symptoms are not as bad. She also has CSF pleocytosis with 100 cells/cu mm. Per the reporter, the subject may have had subtle neurological symptoms for years that had not been reported for medical attention. With exacerbation and remissions, it may be the start of multiple sclerosis. At the time of this report, the subject had not recovered. The causality of the event is reported as associated. Follow up information received on 2/3/2006. The onset date for the second episode of transverse myelitis is reported as 1/27/2006. At the time of this repot, the subject had not recovered. According to the investigator, the event is related to the study, product.					Y	0		Y	N	09/27/2005	09/27/2005	0		UNK	UNK	Clonidine; Lisinopril; Hydrochlorothiazide; Zetia; Nexium; Calcium; Vitamins; Toprol; Aspirin		The patient has a history of hypertension, hypercholesterolemia, gastroesophageal reflux, and cholelithiasis.		200600214	1						1	CSF test abnormal; Condition aggravated; Encephalitis; Injection site erythema; Multiple sclerosis; Myelitis transverse; Neurological symptom; Pleocytosis	FLU3~SANOFI PASTEUR~~UNK~ID~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0251384	02/10/2006	PA	1.23	1	.2	M	02/09/2006	Non Stop crying, seems to be in pain, lethargic, decreased appetite, refusing to walk.										02/08/2006	02/08/2006	0		PVT	UNK		Had fever, vomiting, decreased appetite, trouble sleeping, 3 days prior to vaccine.				1						1	Agitation; Crying; Decreased appetite; Difficulty in walking; Hypokinesia; Lethargy; Pain	DTAPH~SANOFI PASTEUR~U12826C~1~IM~RL~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~U18024AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A65653C~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0251386	02/10/2006	TX	59.0	58		F	02/04/2006	Difficulty breathing, resulting in panic attack, requiring emergency room visit at 2:00am, Ativan injection. Subsequently panic attacks over period of 6-8 weeks, requiring medication (Ativan tablets). This was the first panic attack experienced in my life. I would be too terrified to ever take another flu shot.				Y					Y	11/22/2005	11/23/2005	1		OTH	PVT	Premarin .625 mg.	NONE	NONE			1						1	Dyspnoea; Panic reaction	FLU3~EVANS VACCINES~62216~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0251387	02/10/2006	NY	76.0	76		F	02/08/2006	Stiff neck and pain between shoulders and base of skull.									N	10/03/2005	10/04/2005	1		UNK	UNK						1						1	Musculoskeletal stiffness; Pain	FLU3~SANOFI PASTEUR~U1846AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0251388	02/10/2006	NY	77.0	76		M	02/08/2006	Stiff neck much pain when turning between shoulders and base of skull.										10/03/2005	10/07/2005	4		UNK	UNK						1						1	Musculoskeletal stiffness; Pain	FLU3~SANOFI PASTEUR~U1846AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0251405	02/10/2006	IA	1.5	1	.5	M	02/10/2006	Local reaction right deltoid 4 x 5 cm.				Y					Y	02/07/2006	02/08/2006	1		UNK	UNK		NA				1						1	Injection site reaction	DTAP~SANOFI PASTEUR~41387DA~4~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1861AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0251420	02/10/2006	WA	50.0	49		F	02/10/2006	Rash, arthralgias, swollen joints, red eyes, low grade fever, swollen lymph nodes in groin.				Y					Y	01/20/2006	02/02/2006	13	NONE	PVT	OTH	NONE					1						1	Arthralgia; Joint swelling; Lymphadenopathy; Ocular hyperaemia; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U1808AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0380R~UNK~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0251412	02/11/2006	NH	37.0	37		F	02/11/2006	11/03 severe pain in arm: nerve or bone? Unable to lift objects or arm or lay on arm for @ 4 months, 11/04 same reaction occurred and apparently resolved although a long term illness mimicing auto-immune disease ensued, doctor questioned bursitis.									U	11/04/2003	11/04/2003	0	x-ray, ortho exam, bloodwork	UNK	UNK	none	no	allergies: environmental and pharmaceutical			1						1	Bursitis; Hypokinesia; Pain	FLUX~UNKNOWN MANUFACTURER~~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0251416	02/12/2006	NE	26.0	26		F	02/12/2006	Beginning the evening that I received my pneumonia vaccine, I began to have severe pain in my left arm up through my shoulder.  The area seems to only have some slight swelling and has no bruises or bumps.  The pain is still quite severe, getting worse during the night hours.									N	02/10/2006	02/10/2006	0		UNK	UNK	insulin	none	diabetes			1						1	Hypokinesia; Pain; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0251439	02/13/2006	IA	79.0	78		F	02/13/2006	One day post vaccination patient complained of increasing mild redness and soreness. Whole arm started to swell by the time the patient returned home from our office on the day of immunization. Patient went to emergency room; Benadryl recommended.				Y					Y	12/08/2005	12/08/2005	0		UNK	UNK	Lexapro 20 mg	none	Hyperlipidemia, depression			1						1	Erythema; Pain; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62217~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1044P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0251441	02/13/2006	PA	22.0	21		F	02/13/2006	The patient developed a painful, swollen, mildly red area on her left posterior upper arm.  The patient also experienced an increased heart rate (up to 150 bpm), fevers (up to 40.8 C), and increased white blood cell count (up to 26,000).  She was started on naproxen 250mg by mouth three times daily. Discharge summary states hypotensive, ataxic. msv							Y		Y	01/01/2006	01/03/2006	2	Aspiration of the swollen area of the left posterior upper arm was unsuccessful.  CT scan of the swollen area showed no fluid collection and no free air. Discharge summary states anemia, abnormal lab tests, UA abnormal. msv	UNK	UNK	APAP, azithromycin, ceftriaxone, famotidine, ferrous sulfate, heparin sodium, albuterol nebulizer	Pneumonia	Acute disseminated encephalomyelitis. Discharge summary states hemiparsis. msv			1						1	Anaemia; Aspiration; Coordination abnormal; Erythema; Heart rate increased; Hypotension; Laboratory test abnormal; Pain; Pyrexia; Swelling; Urine analysis abnormal; White blood cell count increased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA131AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1005P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0251443	02/13/2006	MN	0.49	0	.5	M	02/13/2006	Apparent solitary mastocytoma on right thigh where DTaP was given.									Y	11/14/2005	11/17/2005	3		UNK	UNK	none	none	none			1						1	Skin nodule	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B006AA~3~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U186281A~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0343~3~SC~RL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~A94456H~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0251462	02/13/2006	VA	47.0	46		F	02/13/2006	Pt experienced blurred vision, heat and exacerbated (preexisting) headaches which lasted for several hours.  The next day after her return to work she had increased tearing of eyes, persisting headache and a few episodes of increased heat.  The headache it still on going to date.  She has had and ongoing medical concern of hypoglycemia. She was referred to her PCP but declined to go.									Y	02/09/2006	02/09/2006	0	NONE	PVT	UNK	Motrin, Tylenol	headache, nasal drainage	hyperprolactinemia	left hand numbness~Influenza (Seasonal) (no brand name)~1~44.00~In Patient		1						1	Headache; Hypoglycaemia; Lacrimation increased; Pyrexia; Vision blurred	FLUN3~MEDIMMUNE VACCINES, INC.~500389P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0251463	02/13/2006	TX	59.0	59		F	02/09/2006	Flu shot given 11-30-05.  Pt states right arm started hurting same day, and has gotten progressively worse-Pt states took pills from doctor and physical therapy without relief-Pt complained of weakness right hand.  Right upper arm appears normal; no redness, swelling or masses.				Y					N	11/30/2005	11/30/2005	0		OTH	PUB		NONE	Diabetes, HTN, anxiety			1						1	Muscular weakness	FLU3~SANOFI PASTEUR~U1915AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0251464	02/13/2006	TX	1.01	1	.0	F	02/09/2006	Varicella (Dx)-large bumps started on neck-spread to head, arms, chest, abd and back. Treatment: Benadryl-Caladryl									Y	10/18/2005	02/07/2006	112	NONE	PVT	PUB	NONE	Well child	Preme RDS-positional plagiocephaly			1						1	Rash; Viral infection	FLU3~SANOFI PASTEUR~U1805AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE337AA~4~IM~LL~HIB (PROHIBIT)~1|MMR~MERCK & CO. INC.~0233R~1~SC~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|VARCEL~MERCK & CO. INC.~0064R~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0251465	02/13/2006	PA	1.04	1	.0	M	02/07/2006	Child was injected with .5mL of influenza vaccine instead of 0.25mL.  The child appeared well subsequently and no symptoms were thought to occur.									Y	02/06/2006	02/06/2006	0	NONE	PVT	PUB	Singular 4mg	left otitis media with effusion	atopy			1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~01854AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0621R~3~IM~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0320P~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08634D~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0064R~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0251466	02/13/2006	CA	33.0	33		M	02/03/2006	Injection site very swollen and warm to touch and redness around site.									Y	01/30/2006	02/02/2006	3		UNK	PVT						1						1	Feeling hot; Injection site erythema; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62758~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~SANOFI PASTEUR~U1636AA~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0251496	02/14/2006	MS	36.0	36		F	02/10/2006	Patient stated it felt like a sun blister with itching on neck, face and arms. She was given 25 mg Benadryl PO and recovered without complications. No ER visit required.									Y	10/20/2005	10/20/2005	0	NONE	PVT	PUB	Synthroid and Estrace	NONE	NKDA			1						1	Blister; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA145AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0251499	02/14/2006	IN	29.0	28		F	02/14/2006	Vaccine Failure.  Sinus congestion, fever, red painful eyes.  Cough.				Y					Y	10/27/2005	02/01/2006	97	Rapid Nasopharyngeal swab in office Flu A/B test was positive for flu A.	UNK	UNK	WellbutrinXL 150mg po qd Allegra 180mg po qd	none	depression/anxiety allergic rhinitis eczema carpal tunnel syndrome			1						1	Drug ineffective; Eye pain; Nasal congestion; Ocular hyperaemia; Pyrexia; Viral infection	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61998~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0251509	02/14/2006	CA	64.0	64		F	02/14/2006	Extreme pain  for a week, limited motion and weakness left  shoulder and arm since 12/8/05. Treatment: Vicodin, Prednisone, Physical therapy.				Y					N	11/23/2005	12/08/2005	15	Blood test, X-ray, MRI, EMG	UNK	UNK						1						1	Joint range of motion decreased; Muscular weakness; Pain	FLU3~SANOFI PASTEUR~1816AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0251515	02/14/2006		55.0			F	02/14/2006	This case was reported in a literature article and described the occurrence of a cutaneous lymphoid hyperplasia in a 55 year old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. On an unspecified date the subject received 1st dose of influenza vaccine (unknown, right deltoid). Within days of vaccination with Influenza vaccine, the subject developed an erythematous, non tender 1cm nodule within the inoculation site. Over the ensuing eighteen months, it gradually enlarged, and became pruritic and indurated. A biopsy revealed marginal zone B cell lymphoma. A staging evaluation including computed tomography scans of the chest and abdomen had no evidence of disease beyond the deltoid area. A four week course of radiotherapy resulted in a complete clinical regression. The patient developed recurrent disease on the contralateral anterior shoulder eighteen months after her initial presentation. She was not aware of any predisposing events localized to this site. The 1 CM recurrent lesions was excised with no further treatment. Histopathologically, both tumors had similar findings. the nodular proliferation's were characterized by a cellular lymphoplasmatic perivascular and periadnexal infiltration with mild cytologic atypia. Both tumors occupied the full thickness of the reticular dermis. There were no well formed germinal centers. The infiltrations were composed of small to medium sized lymphocytes, histiocytes and sheets of peripherally located plasma cells. Classic marginal zone of monocytoid lymphocytes were not conspicuous. The majority of the lymphoid cell were positive for the pan T cell markers CD3 and CD5. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the events were resolved. The author considered the events were related to vaccination with influenza vaccine.									Y					OTH	OTH					B0410963A	1						1	Erythema; Hyperplasia; Injection site hypersensitivity; Injection site induration; Injection site nodule; Lymphoma; Neoplasm; Pruritus; Skin ulcer; Injection site erythema; Injection site induration; Injection site nodule; Injection site reaction; Pruritus; Pseudo lymphoma; Skin ulcer	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0251516	02/14/2006		65.0			F	02/14/2006	This case was reported in a literature article and described the occurrence of lymphoid hyperplasia in a 65 year old female subject who was vaccinated with influenza virus vaccine (influenza vaccine, manufacturer unspecified) for prophylaxis. On an unspecified date the subject received 1st dose of influenza vaccine (unknown, right deltoid). Within days of vaccination with influenza vaccine, the subject developed a pruritic nodule at the injection site. Within a few days after the injection the nodule grew to 2 cm in diameter. Despite therapy with antibiotics and warm compresses, the lesion continued to increase in size. A biopsy performed 6 weeks after initial presentation revealed granulomatous and mixed cellular infiltration that was interpreted as reactive in nature. No pathologist microorganisms were identified histologically or in cultures obtained from lesional tissue. Within a month after initial biopsy, the nodule had enlarged to 5 cm and had begun to ulcerate. The lesion was resected, and revealed a similar reactive histology compared to the initial biopsy. Over the next 2 years, the lesion continued to increase in size and ulcerate, despite numerous attempts at resection and various courses of oral and topical corticosteroid therapy. Cultures for infectious microorganisms were consistently negative. Ultimately, a course of low dose radiotherapy was administered three years after the initial presentations and resulted in complete regression of the lesions and healing of the overlying epidermis. The patient has not had a recurrence within a nine year follow up period after radiation treatment. Histologically, all tissues had similar findings. The epidermis was ulcerated, and the full thickness of the reticular dermis was effaced by a sheet of cells extending into subcutaneous fat. The inflammatory proliferation was comprised of a cellular, atypical but polymorphic lympho histiocytic population of mononuclear cells. The proliferation was characterized by mostly small to medium sized lymphocytes, some with a plasmacytoid appearance on a histiocytic background. Larger immunoblastic cells made up a small component of the infiltration. In addition, there were scattered area of necrotizing granulomatous inflammation within the cellular dermal. This case was assessed as medically serious my manufacturer (OMIC). At the time of reporting the events were resolved. The author considered the events were related to vaccination with influenza vaccine.									Y					OTH	OTH					B0410977A	1						1	Granuloma; Hyperplasia; Injection site hypersensitivity; Injection site inflammation; Injection site nodule; Pruritus; Skin ulcer; Granuloma; Injection site hypersensitivity; Injection site nodule; Pruritus; Pseudo lymphoma; Skin ulcer	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0251528	02/15/2006	OR	44.0	44		M	02/06/2006	Patient appears to exhibit brachial neuritis in shoulder. Pain, weakness, burning. Not yet receiving treatment started about few weeks post vaccination.									N	12/05/2005	01/01/2006	27		OTH	PVT	UNK	NONE	NONE			1						1	Asthenia; Pain; Radiculitis brachial; Skin burning sensation	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA126BC~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0251552	02/15/2006	CA	1.04	1	.0	F	02/15/2006	L leg limp, unable to walk on it, redness, water filled blister at sight, (L thigh) (varicella lesion)? Treatment-Dr visit-CBC, ESR drawn, Motrin for pain, re check leg next day 2/16/06				Y					N	02/13/2006	02/14/2006	1	CBC, ESR-drawn	PUB	PUB		NONE	NONE			1						1	Blister; Erythema; Hypotonia	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~SANOFI PASTEUR~687AA~4~~LL~HIB (PROHIBIT)~1|MMR~MERCK & CO. INC.~0235R~1~~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~08634B~4~~LL~PNEUMO (PREVNAR)~1|VARCEL~UNKNOWN MANUFACTURER~0782R~1~~RL~VARICELLA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0251557	02/16/2006	CA	58.0	58		M	02/10/2006	2 large welts around bicep to armpit-100.4 fever-severe pain-24 hours after shot									Y	02/08/2006	02/09/2006	1		MIL	UNK		NONE				1						1	Hypersensitivity; Pain; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0251571	02/16/2006	TX	35.0	35		M	02/16/2006	Reaction to smpx vac site beginning with red streaking extending down arm and across chest-dx w/cellulitis. Also had swollen lymph nodes in armpit and by clavical on left side. Day 5 I had chest pain and high blood pressure. Numerous test given to check my heart with doctor.				Y	Y	1			Y	01/26/2006	01/29/2006	3	Data pending: ER and cardiology eval.	MIL	MIL	denies	denies	denies			1						1	Cellulitis; Chest pain; Erythema; Hypertension; Lymphadenopathy; Skin striae	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~~1~~LA~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~~UNK~~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Hospitalisation	Influenza
0251579	02/16/2006	TX	57.0	56		M	02/15/2006	11/02/05 felt mild discomfort, feverish. until 11-12 started achiness in elbow and shoulder. 11-15 all joints were in pain 11-21 excruciating pain joints and muscles, took Fluricet (did not help). 11-25 started Prednisone (didn't help) 12-17 and 12-21 oxycodone 5 & 10 mg (didn't help) 12-9 hydrocodone 10 mg (didn't help) 1-3-06 Penicillin started taking Royal Jelly 12/22/05 until now (seemed to help).				Y	Y	3			Y	11/01/2005	11/02/2005	1	Cytomegalovirus IgG 0.20, cytomegalovirus IgM 0.47, Alkaline phosphatase 350 H, A/G ratio 1.0 L, Serum albumin 3.1 L, Serum chloride 92 l, Serum sodium 131 L, Monocytes 1.2 H, Lymphs 4 L, Neutrophils 86 H, Platelets 478 H, Hematocrit 32.9 L, Hemoglobin 11.2 L, RBC 3.56 L, White blood cell 14.8 H, Sedimentation rate 98 H, BUN 35 H, Creatinine 1.7 H, Chloride 95 L, HDL Cholesterol 32 L, Glucose H, TSH H, T3 uptake H,	PVT	PVT	Aldactone, Coumadin, Digoxin, Coreg, Lasix, Lexapro, Diovan, Potassium, Levoxyl.		Heart attack and open heart surgery, A fib, Hyperthyroidism, Hypertension			1						1	Albumin globulin ratio abnormal; Arthralgia; Blood albumin decreased; Blood alkaline phosphatase increased; Blood chloride decreased; Blood chloride increased; Blood cholesterol decreased; Blood creatinine increased; Blood glucose increased; Blood sodium decreased; Blood urea increased; Discomfort; Haematocrit decreased; Haemoglobin decreased; Laboratory test abnormal; Lymphopenia; Monocytosis; Myalgia; Pain; Platelet count increased; Pyrexia; Red blood cell count decreased; Red blood cell sedimentation rate increased; White blood cell count increased; Arthralgia; Immune system disorder; Laboratory test abnormal; Myalgia; Pyrexia; Red blood cell sedimentation rate increased	FLU3~SANOFI PASTEUR~U1903AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1903AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0251580	02/16/2006	NC	75.0	74		F	02/16/2006	Discomfort L arm 2-10-06; Induration and erythema; tenderness; temp 100.  Treatment-Medrol Dose pack and Keflex 500 mg 3 times a day for 7days. 2-13-06 (Patient reports resolving)									Y	02/08/2006	02/10/2006	2	NONE	PVT	PVT		NONE				1						1	Erythema; Injection site induration; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~U1858FA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1049P~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0251581	02/16/2006	TN	17.0	16		M	02/16/2006	2/9/06 received vaccines at about 1615.  Pt reports at about 2200 starting having sharp abdomen pain and became lightheaded, everything in vision became red in color. Pt reports vomiting next AM 2x's. Then states saw spots in different colors at times in peripheral vision.									N	02/09/2006	02/09/2006	0	NONE	PVT	PVT		NONE	Sickle Cell Disease (Hgb SC)			1						1	Abdominal pain; Chromatopsia; Dizziness; Visual disturbance; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61128~5~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|MNQ~SANOFI PASTEUR~U1893AA~UNK~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0251599	02/17/2006	KS	67.0	67		F		L upper arm with redness, edema, warm to touch sore. No shortness of breath.				Y						10/11/2005	10/11/2005	0		PUB	UNK		NONE	NONE		KS200530	1						1	Erythema; Feeling hot; Oedema	FLU3~SANOFI PASTEUR~U1744AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0513P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0251600	02/17/2006	NE	57.0	57		F	01/26/2006	Received Td in L deltoid on 11-14-05.  On 11-21 arm became itchy, red, warm and swollen and began losing feeling in fingers.  Saw MD on 11-21-05.  Was treated with antibiotics and steroids.				Y					Y	11/14/2005	11/21/2005	7		OTH	PVT	Claritin, Flonase, Lipitor, Prempro	NONE				1						1	Erythema; Feeling hot; Hypoaesthesia; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U1881AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U1206CA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0251601	02/17/2006	CA	36.0	36		M		Itching, dry cough, sore throat, headache, sinus congestion, eye redness, myalgia, wheezing inspiratory, tickle in chest, child pruritus.  Symptom started 4 hours after injection. A 36 year old male patient with no known allergies, had received an intramuscular injection in the left deltoid and 4 hours later, he experienced tickle in chest, dry cough, sore throat, injected sclera, myalgia, chills, injection site soreness and rash on his left hand.  It was worth noting that the patient had enlarged tonsils but was not ill at time of the vaccination.  The concomitant treatment was not provided. The patient had already received previous doses of Influenza vaccine. The patient received diphenhydramine hydrochloride (Benadryl) per os as corrective treatment.  The patient recovered on an unspecified date.				Y					Y	11/09/2005	11/09/2005	0	No labs	PUB	PUB		No illnesses at time of vaccination.	No known allergies, enlarged tonsils		200502424	1						1	Cough; Eye irritation; Headache; Myalgia; Pharyngolaryngeal pain; Pruritus; Sinus congestion; Wheezing	FLU3~SANOFI PASTEUR~U1828AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0251626	02/17/2006	CT	10.0	10		M	02/17/2006	Patient received the Td and flu shots on 12/22/05.  That evening, mother reported patient to be feeling ill.  He was then seen to have a tonic clonic seizure by mom that she believes lasted about 3 minutes.  Since she was frantic at the time, it is unk. the exact length of the sz or if he had a fever at the time.  Either way, a neighbor took him to a local ED, where a w/u was done.  No fever was reported, no meds given to stop the sz.  An MRI/EEG/blood work was done that were all negative (BLOOD INCLUDED CBC and Lytes).  Patient was d/c'd from the ED without meds.  Patient has since returned to baseline without any recurrence of seizure activity.				Y					Y	12/22/2005	12/22/2005	0	Neg Brain MRI  Neg EEG Nl blood work	UNK	UNK	flovent 44mcg 2 puffs BID albuterol MDI 2 puffs q4h PRN alavert 10mg qd	none	asthma developmental delay with LD eczema			1						1	Convulsion; Malaise	FLU3~SANOFI PASTEUR~U1823AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U1221CA~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0251636	02/17/2006	NY	1.21	1	.2	M	01/24/2006	Child one minute later vomited immediately and then became hyporesponsive. Responded well to Epi, O2 and Albuterol treatment. Transported to ER.				Y					Y	01/24/2006	01/24/2006	0		PUB	PUB	Polyviflor with Fe		Eczema/atopic dermatitis			1						1	Stupor; Vomiting	FLU3~SANOFI PASTEUR~U1836AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08634A~UNK~~~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0251639	02/17/2006	VA	48.0	48		M	02/17/2006	Pt expressed no pain at time of vaccine. Direct soreness at injection site (but no redness or swelling) which pt says never went away and got worse over next weeks to include neck and right upper arm. Now with electric shock type pain of both upper arms with extreme abduction L>R. Also with bladder incontinence and involuntary upper body tremors-rarely .  Referred by PCP to Urology to Neurology to rule out neurological issues. Pain is only with movement upper arms. All symptoms began same time.									U	11/02/2005	11/03/2005	1	MRI, EMG testing scheduled by neurologist 2/21/06.	PUB	OTH	Paxil, Alprazolam, Flomax		Information received from Medicl records states Urinary incontinence, anxiety and back pain as parts of medical Hx. msv			1						1	Musculoskeletal stiffness; Myalgia; Pain; Tremor; Urinary incontinence	FLU3~SANOFI PASTEUR~U1825BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0251648	02/20/2006	IL	44.0	44		F	02/20/2006	Developed an abscess at site of injection.  Received antibiotics and warm compresses to site which helped relieve abscess.				Y					Y	10/21/2005	10/30/2005	9		UNK	UNK						1						1	Injection site abscess	DT~BSI~U484R~1~IM~LA~DT ADSORBED (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1761AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0484R~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0251649	02/20/2006	MD	84.0	83		M	02/20/2006	Patient administered Pneumococcal vaccine in upper right arm.  Area of warmth and redness observed.									Y	02/18/2006	02/19/2006	1		UNK	UNK	Tylenol, Tessalon, Lovenox, guaifenisin la, Moxifloxacin, potassium chloride	Bronchitis	Community -acquired pneumonia, Thrombocytopenia			1						1	Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~u1914aa~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1118r~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0251274	02/21/2006	GA	1.01	1	.0	M	02/14/2006	Initial report received from another manufacturer, report number WAER0511USA00930, on 2/8/2006. Information was received from a physician concerning a 12 month old male patient with an allergy to Augmentin who received, on 10/21/2005, an injection of Fluzone SV 2005-2006, lot number and route and site of administration not reported, an injection of MMR II, lot number and route and site of administration not reported, a first dose, right thigh, injection of Varivax, lot number and route of administration not reported, and an injection of Prevnar, manufacturer, lot number and route and site of administration not reported. Events outlined at the beginning of this report included oral candidiasis, eye discharge and varicella. Eleven days post vaccination, on 11/1/2005, the patient developed fever of 102 degrees F and papulopustular lesions around the injection site of the right thigh. On 11/4/2005, he developed gunky eyes and continued with fever between 102 and 103 degrees F. On 11/6/2005, the patients fever was 105.2 degrees F. He was examined in an ER and started on Zithromax. It was noted that the patient was on Zyrtec as that time. Abnormal laboratory findings included C reactive Protein 12.4 mg dl (HIGH), WBC 20.7 (HIGH), hemoglobin 10.2 (LOW) and hematocrit 29.8 (LOW). A strep screen was negative. The patient was re examined by his physician on 11/7/2005, and at that time, had a cluster of lesions at the injection site of the right thigh (now x one week) and one pustule on his neck (for several days). He also had thrush on the buccal mucosa and on the left tonsil. It was noted that he had been on Augmentin since 10/28/2005. The physical examination showed that his nose/sinus, mouth/teeth, throat and skin were abnormal. The patient was treated with nystatin. Concurrent conditions listed by the reporter included an allergic reaction to antibiotics. There was no mention of hospitalization for these events. However, the patients adverse events were determined to be other important medical events by the physician (OMIC). Per the reporter, the patient had recovered.				Y					Y	10/21/2005	11/01/2005	11		UNK	UNK	Zyrtec		The patient has an allergy to Augmentin.		200600289	1						2	Blood gases abnormal; Candidiasis; Dermatitis bullous; Eye discharge; Haematocrit decreased; Haemoglobin decreased; Injection site reaction; Laboratory test abnormal; Pyrexia; White blood cell count increased; Candidiasis; Eye discharge; Haematocrit decreased; Haemoglobin decreased; Hypersensitivity; Injection site reaction; Laboratory test abnormal; Pyrexia; Rash papular; Rash pustular; Skin disorder; Skin ulcer; Viral infection; White blood cell count increased	FLU3~SANOFI PASTEUR~~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~~UNK~~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~~UNK~~UN~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~~UNK~~UN~VARICELLA (VARIVAX)~1|FLU3~SANOFI PASTEUR~~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|MMR~MERCK & CO. INC.~~UNK~~UN~MEASLES + MUMPS + RUBELLA (MMR II)~2|PNC~PFIZER\WYETH~~UNK~~UN~PNEUMO (PREVNAR)~2|VARCEL~MERCK & CO. INC.~~UNK~~RL~VARICELLA (VARIVAX)~2	USA	Emergency room visit	Influenza
0251515	02/21/2006		55.0			F	02/15/2006	Seriousness criteria other medically significant (OMIC). Initial report received on 2/10/2006 from a literature review. A 55 year old patient had received an influenza virus vaccination (manufacturer, lot number and site were not reported) in the right deltoid area and within a few days, developed a non tender, erythematous 1cm nodule within the inoculation site. Over the next 18 months, the nodule gradually enlarged and became indurated and pruritic. A biopsy showed MALT lymphoma. The nodular proliferation had a cellular lympho plasmacytic perivascular and periadnexal infiltration with mild cytologic atypia. In situ hybridization studies showed monotypic kappa light chain restriction within plasma cell clusters. A 4 week radiotherapy course resulted in a complete clinical regression. Eighteen months after her initial presentation, a Histopathologically similar lesion recurred on her contralateral anterior shoulder, and was excised. A second patient with the same lymphoproliferative disorder was reported and is referenced in case number 200600331.				Y					Y					UNK	UNK					200600330	1						2	Erythema; Hyperplasia; Injection site hypersensitivity; Injection site induration; Injection site nodule; Lymphoma; Neoplasm; Pruritus; Skin ulcer; Injection site erythema; Injection site induration; Injection site nodule; Injection site reaction; Pruritus; Pseudo lymphoma; Skin ulcer	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0251516	02/21/2006		65.0			F	02/15/2006	Seriousness criteria other medically significant (OMIC). Initial report received on 2/10/2005 from a literature review. A 65 year old patient had received an influenza virus vaccination (manufacturer, lot number and site not reported) and developed a pruritic nodule with the inoculation site in her right upper arm, which grew to 2cm in diameter within a few days after the injection. She received anti bacterial and warm compresses, but her lesions continued to grow. Six weeks after initial presentation, a biopsy showed a granulomatous and mixed cellular reactive infiltration, which was comprised of atypical but polymorphic lympho histicoytic mononuclear cells. In Situ hybridization studies showed polytypic plasma cell populations. Within one month of the biopsy, her lesion continued to grow and ulcerate, despite numerous resection attempts and oral and topical corticosteroid treatment. Three years after initial presentation, radiotherapy resulted in a complete regression of her lesion and healing of the overlying epidermis. Her lesion did not recur during nine years follow up. A second patient experienced lymphoproliferative disorder and that case is referenced in case number 200600330.				Y					Y					UNK	UNK					200600331	1						2	Granuloma; Hyperplasia; Injection site hypersensitivity; Injection site inflammation; Injection site nodule; Pruritus; Skin ulcer; Granuloma; Injection site hypersensitivity; Injection site nodule; Pruritus; Pseudo lymphoma; Skin ulcer	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0251658	02/21/2006	MI	0.5	0	.5	F	02/17/2006	Initial report received on 09/Nov/2005 from a health care professional. A six month old female had received her first administration (route and site not reported) of Fluzone No. Preservative '2005-'2006 (lot number not reported) on 02/Nov/2005. Per the reporter, at an unspecified time later the mother brought the child in for her well baby check up and it was noted the child was restless. A WBC was drawn and the child had a WBC level of 20,000 with no reported infectious process. The patient had received on 07/Sep/2005 vaccinations with ACTHIB, Dtap, IPV and Prevnar. None of the manufacturer's names, lot number or route and site of administration were reported. The patient had not recovered from this event a the time of this report. Seriousness Criteria: Other Medically Significant (OMIC). This case was upgraded to seriousness due to the diagnosis of anemia. Follow-up information received on 06/Feb/2006 from a health care professional. It was reported that the patient had a yeast infection and a history of GERD at the time of the vaccination. She was vaccinated with Fluzone, lot number U17U3JA, intramuscularly in the left thigh on 02/Nov/2005. At an unspecified time later, the patient experienced greater than three hours of crying that was difficult to console for 48 hours. The child was described as being wired/irritable and agitated but had no fever. She would not sleep for 11 hours. There was no visible signs of redness or swelling at the injection site. In retrospect, a similarly reaction occurred at the patient's two month old vaccinations on 12/Jul/2005 with Dtap, Polio, HIB and PCV7, but this was attributed to a bad yeast infection since the baby was breast feeding. The patient did develop a low grade fever and was given Tylenol by the mother and this was reported to the physician on 10/Sep/2005. On 09/Nov/2005, the patient had elevated WBC's and it was felt that the patient was too far out from the vaccination to be related to the vaccine. A repeat CBC with differential, AST, ALT, Cold agglutinins and peripheral smear were completed. The results revealed WBC to be 15.8, Hgb 10.4 and Lymphs 64%. On 18/Nov/2005 the physician felt the current adverse events were compatible with the flu vaccine and not related to the history of GERD, Zantac or Prevacid. On 26/Dec/2005 an upper endoscopy with biopsy was completed and did not show any bleeding. It was recommended that Poly-Vi-Sol with iron be given with food for the anemia. A repeat CBC was to be completed in one month. On 11/Jan/2006 the mother gave up garlic and onions and the patient's screaming stopped for six-seven days. An allergy workup was completed and was negative. On that day her WBC's were 16.9, Hgb 10.2 and Lymphs were 77%. Per the reporter, it is uncertain about the cause of the adverse reaction following the vaccination. The child seems much better since the mother gave up garlic and onions. The physician plans to pre-medicate with Tylenol and Benadryl before the next immunizations. A repeat CBC will be repeated at the next child visit on 08/Feb/2006. At that time the physician will consider a hematology consult. The events were updated per this information. At the time of this report, it was not reported if the patient had fully recovered from these events.				Y					N	11/02/2005				PVT	PVT	Zantac;Prevacid		Patient had no illnesses at time of vaccination. She has a history of GERD and takes Zantac. Follow-up information received on 06/Feb/2006: Patient had a yeast infection at the time of the vaccination. The patient had vaccinations of Dtap, Polio, HIB and PCV7 on 12/Jul/2005 at two months old. No vaccinations were received within four weeks of this vaccination.		200502403	1						1	Agitation; Anaemia; Crying; Insomnia; Irritability; Restlessness	FLU3~SANOFI PASTEUR~U1743JA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0251669	02/21/2006	PA	70.0	70		F	12/21/2005	Progressive paralysis, admitted hospital 11/23/2005. Discharge summary states Guillain-Barre syndrome, respiratory failure, bacterial infection, anemia, hypotonia, paresthesia, decreased reflex. msv. 60 Day Follow-up Information 09-MAY-2006: Persistent paralysis and reporter dependent.				Y	Y				U	10/06/2005	11/22/2005	47	Discharge summary sttes EEG abnormal. msv	PVT	PVT	Accupril, Cardizem					1						1	Anaemia; Bacterial infection; Bacterial infection; Electroencephalogram abnormal; Guillain-Barre syndrome; Hyporeflexia; Hyporeflexia; Hypotonia; Laboratory test abnormal; Paraesthesia; Paralysis; Respiratory failure; Respiratory failure	FLU3~SANOFI PASTEUR~U1869AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0251672	02/21/2006	OR	44.0			F	02/15/2006	(OMIC) I had a flu shot and I have a two numb fingers and my arm was very sore and itching and my arm feels numb only my half of my arm, I do not have any medical and I am waiting okay for some financial help. I have had flu shots before and never in my life have I had this reaction. This is the worst flu shot I have ever had. Nothing showed up until about 3 weeks after. My arm is not getting any better. I did not ask for this. I tried taking vitamin be for my nerves but it has not went away. Fluarix is the vaccine and it is bad. I will have to work this out. In the mean time I want someone to know about this. The numbness is no fun and I hope this vaccine wares off if not my arm is permanently have numb and I have to live with this.											12/20/2005			UNK	UNK						1						1	Hypoaesthesia; Pain; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0251673	02/21/2006	AK	29.0	28		F	12/28/2005	Client reported developing hives the evening of 12/23/05.  Was seen ER 12/24/05-was told that hives were probably not related to flu vaccine, unknown what caused hives. Given steroid and Benadryl to take.				Y					N	12/23/2005	12/23/2005	0	Hives still occurring off and on.	PUB	PUB	NONE	Reported slight fever earlier in week.			AK200606	1						1	Urticaria	FLU3~SANOFI PASTEUR~U1754AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0251674	02/21/2006	AK	76.0	76		F	12/01/2005	Soreness at site of pneumonia vaccine 1st night, some itching noted-redness and swelling noted from shoulder to elbow. Lasted 2 weeks. 1st called 11/4/05-noted some improvement after five days 11/4/05. Follow up 12/1/05.									Y	10/31/2005	10/31/2005	0	NONE DONE	PUB	PUB		NONE			AK200602	1						1	Myalgia; Pruritus; Swelling	FLU3~SANOFI PASTEUR~APU1754AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0346B~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0251675	02/21/2006	AK	63.0	63		F	02/03/2006	Client reports soreness in L deltoid after receiving flu vaccine. Soreness has never gone away and has increased in intensity. Also complained of limited range of motion with L arm. Saw PMD 1/25/06-referred to vaccine provider. Referred back to PMD.				Y					N	10/21/2005	10/21/2005	0		PVT	PUB		NONE	Pre-diabetic		AK200601	1						1	Joint range of motion decreased; Myalgia	FLU3~SANOFI PASTEUR~U1754AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0251676	02/21/2006	ND	1.03	1	.0	F	02/16/2006	Pt had seizure 5 minutes after administration of 12 month immunization. Seen in  ER had T 103. Fine 2 minutes after event. No further fever or seizure. Information recieved from Medical records states staring, drooling sliva and jerking as additional symptoms. msv				Y					Y	11/17/2005	11/17/2005	0	NI CBC, CXR, BMP	PVT	PUB	NONE	NONE	NONE Information from Medical records state ear infections as Hx. msv			1						1	Convulsion; Drooling; Muscle twitching; Pyrexia; Stupor	FLU3~SANOFI PASTEUR~U1787EA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A74406E~4~~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~06QSR~1~~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0251677	02/21/2006	NC	1.26	1	.3	M	02/03/2006	Approx 15 minutes after immunizations were given-child's face became red and developed hives-resolved quickly.									Y	02/03/2006	02/03/2006	0	NONE	MIL	PUB	NONE	NONE	NONE			1						1	Erythema; Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B005AA~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1914AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0942R~1~IM~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0251678	02/21/2006	MN	32.0	32		F	12/21/2005	Received shot at 11:00 AM, approx 4:30 PM patient began feeling short of breath a little, with a lump in the base of my throat, kind of dizzy, arm was achy and sore in antecubital area. These sx slightly improved around 6 and by 7:30 PM were gone. Approx 10 PM pt. was hit with the typical flu sx: shivering/chills, extremely achy, weak, headache, tired. Pt. went to bed and in AM was fine.									Y	11/27/2005	11/27/2005	0	NONE	PUB	PUB	Retina cream Qd, minocycline BID	end of approx 7 days of flu like sympt	NONE			1						1	Asthenia; Chills; Dizziness; Dyspnoea; Headache; Influenza; Myalgia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0251679	02/21/2006	CA	9.0	8		M	02/10/2006	Exacerbation of asthma, cough and MD diagnosis bronchitis.				Y					Y	01/28/2006	01/29/2006	1	NONE	PUB	OTH	NONE	NONE	Asthma			1						1	Asthma; Bronchitis; Cough	FLUN3~MEDIMMUNE VACCINES, INC.~500409P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0251680	02/21/2006	TX	71.0	70		F	02/16/2006	Patient given flu vaccine on 10-18-05 and had symptoms of flu on 1-18-06. Pt confirmed with flu by throat culture. Pt had Influenza A. Possible vaccine failure.									Y	10/18/2005	01/18/2006	92	throat culture positive for Influenza A	PVT	OTH	Minipress, Lantus, aspirin EC, Oxozide, Prinivil	NONE	Allergies: Sulfa, Tetanus. Conditions: DM, HTN, Hep C, increased lipids.			1						1	Influenza; Laboratory test abnormal; Vaccination complication	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA138BA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0251681	02/21/2006	SC	65.0	65		F	02/10/2006	I had flu shot about 3:00 PM Nov 15. 6:30 AM Nov 16 my left leg would not hold me up. 8 days later I could walk normal. My three middle toes on left foot swelled up. I could only wear sneakers. Ball of left foot swelled and to this day I feel like I'm walking on a wad of gum and my toes are still numb.									N	11/15/2005	11/16/2005	1		PUB	UNK	Lotrel 5/20-1 daily, ACT 05 45 1/2 daily.	NONE	Hypertension, diabetes			1						1	Hypoaesthesia; Muscular weakness; Oedema peripheral	FLU3~SANOFI PASTEUR~U1831AB~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0251682	02/21/2006	PA	6.0	6		M	01/13/2006	Child received influenza vaccine on 1-11-06. On 1-13-06 mother phoned in stating since 4 am on 1-13-06 child vomiting. Small diarrhea stool noted. Mother instructed to call family physician due to concern of dehydration.									U	01/11/2006	01/13/2006	2	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Dehydration; Diarrhoea; Vomiting	FLU3~SANOFI PASTEUR~U1746AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0251763	02/22/2006	VA	26.0	26		M	02/22/2006	Presents for education of what vaccines he can/cannot take with thimerasol and neomycin allergies.  Has taken FluMist, IM Influenza w/o adverse events since allergies identified.  Received allergy testing 4/2002 following a one year history (onset Feb 2001) of chronic left TM rupture/OM partially responsive to treatment (neomycint gtt, po Augmentin, Sudafed, then cortisporin otic gtts, acetic acid gtts, cipro HC gtts and po).  ENT referrals began in July 2001. He later developed bilateral eczema dermatitis to external ear canals tx w/Valisone/Diprolene.  On December 7, 2001 he presented to ER w/bilat eye swelling, painful itching face with papules and scales c/w eczema.  He stated onset began w/Cipro use last October w/wo med use but s/s worse.  Used Hydrocortisone cream w/relief. Dx Eczematous blepharitis w/periorbital edema in raccoon eye distribution. F/u exams dx eczematous papular rash (ear) left neck and shoulder ?to debonide? Resolution of symptoms was documented 12/20/01 with dx hypertension and EKG changes after prednisone use.  Eczematous Plaque to lt jaw and pinpoint periorbital papules upper lids returned @ 2/11/02. By 4/2002 his dx centered towards airborne allergic contact vs adult eczema. Patch testing ordered - positive for thimerasol (3-4+), neomycin sulfate (0-1) and epoxy resin (0-1). Referral to allergy and immunology was conducted 12 Jan 06 following use of desomide about eyes in 2001-2.  Can he received flu shot and tetanus shot as no problems w/previous vaccines?  Has seafood allergy to lobster (tightness of throat/swallowing prob).				Y					Y	11/29/2001	04/01/2002	123	none	MIL	MIL	none at time of reaction	chronic OM/URI	eczema, hypyerlipidemia			1						1	Condition aggravated; Dermatitis; Eczema; Electrocardiogram abnormal; Eye irritation; Eye oedema; Eye swelling; Hypersensitivity; Hypertension; Otitis media; Pain; Rash papular; Skin exfoliation	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0246583	02/23/2006	MA	63.0	63		M	02/20/2006	Initial report received from another manufacturer, report number WAES0511USA03790, on 2/15/2006. Information was received from a health care professional concerning a 63 year old male patient, with a history of asbestosis, who received an intramuscular, left arm injection of Fluzone SV 2005-2006, lot number 01854AA (not a valid manufacturer lot number), and an intramuscular, first dose, right deltoid injection of Pneumovax 23, lot number 649693/0456P, on 10/26/2005. Three hours post vaccination, the patient developed severe pain from his shoulder to his elbow (specific arm not specified), and could barely move it. Seven hours post vaccination, he developed swelling and redness from his shoulder to his elbow. He also was unable to sleep and experienced blurry vision. The patient was examined in an ER, on 10/27/2005, and treated with a Medrol Dosepak. No laboratory or diagnostic test were performed. Subsequently, the patient mad a full recovery on 10/29/2005. The event was considered to be an important medical event per the reporter (OMIC). This reporter is the same as for case 200600361.				Y					Y	10/26/2005	10/26/2005	0		UNK	UNK	Lipitor, Celexa, Lisinopril, Hydrochlorothiazide, Vitamins				200600360	1						2	Hypokinesia; Injection site hypersensitivity; Injection site oedema; Injection site pain; Insomnia; Vision blurred	FLU3~SANOFI PASTEUR~01854AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0456P~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0251779	02/23/2006	AZ	0.68	0	.7	F	02/23/2006	Approximately one hour after receiving the flu shot, my daughter had red blotches/bumps all over her body.  She began tugging her ears and they became swollen as well. 3/7/06 Received ER medical records which revealed patient experienced acute allergic reaction w/hives, rash & facial edema/ss				Y					Y	12/05/2005	12/05/2005	0		UNK	UNK		none	none			1						1	Ear pain; Erythema; Face oedema; Hypersensitivity; Rash; Rash macular; Swelling; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0251780	02/23/2006	MD	38.0	38		M	02/23/2006	ON 9 JAN 06, PT WAS SCREENED & RECEIVED TD VACCINE IN RT UPPER ARM AND FLU VACCINE IN LEFT UPPER ARM. HE RETURNED TODAY COMPLAINING OF CONSTANT DEEP STABBING PAIN IN UPPER RIGHT ARM FOR APPROX 6 WEEKS. STATES THE PAIN OCCURS WHEN HE DOES LATERAL FULL ARM RAISES, OR BACKWARDS ARM MOTIONS. HE VOICED NO OTHER ADVERSE SYSTEMS REACTIONS. PT IS DIRECTED TO SEE HIS PRIMARY CARE MANAGER TODAY. PT REPORTS TODAY THAT HE HAD COMPLETED A REGIME OF PREDNISONE 4 DAYS PRIOR TO RECEIVING THE CURRENT VACCINATIONS.									U	01/09/2006	01/09/2006	0	NONE	UNK	UNK	NA	NONE	NONE			1						1	Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U1858CA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TTOX~SANOFI PASTEUR~U1620AA~2~IM~RA~TETANUS TOXOID, ADSORBED (NO BRAND NAME)~1	USA		Influenza
0251783	02/23/2006	NJ	1.0	0	1	F	02/23/2006	Vaccines were given at approximately 11:30 AM.  Mother states child had fever and seizure at home at 11:00 PM that same night. Tylenol was given by parent 1 time. Child was taken and seen at ED. Information received from ER summary states vomiting and confusion as symptoms.  msv				Y					Y	02/21/2006	02/21/2006	0		UNK	UNK		none	None			1						1	Confusional state; Convulsion; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1867CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0237R~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A74406A~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0587P~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0251791	02/23/2006	OH	57.0	57		F	02/23/2006	10/28/05 Patient developed cold and flu symptoms and neck pain 10/31/05 patient had facial paralysis ED physician diagnosed with Bell's palsy Hospital employee				Y					Y	10/28/2005	10/28/2005	0		PVT	OTH						1						1	Facial palsy; Influenza like illness; Neck pain; Paralysis; Pharyngitis; Rhinitis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA138AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0251817	02/24/2006	WA	33.0	32		F	02/24/2006	Left arm numb and tingly. Dec to present needle pricks randomly off and on thru out body.									U	11/17/2005	11/26/2005	9	Neurologist appt 2/1/06- Brain MRI;Thoracic-cervical MRI done	OTH	PUB		NONE	Allergy shots- dust mites, seasonal	MS~Varicella (no brand name)~~31.00~In Sibling|~Varicella (no brand name)~~0.00~In Sibling		1						1	Hypoaesthesia; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62217~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0251818	02/24/2006	MI	45.0	44		F	02/20/2006	2 hrs after receiving flu vaccine C/O headache, intermittent dizziness with fever. No Dx. 2/7/06 C/O fatigue, muscle aches. No fever.									Y	02/06/2006	02/06/2006	0	CBC-OK;TSH-normal;Influenza A&B antigen negative;Comprehensive Profile OK	PVT	PVT	AeroBid;Albuterol;ASA	Felt like coming down with cold	Asthma;Allergic PCN			1						1	Dizziness; Fatigue; Headache; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U1911AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0251832	02/24/2006	MI	47.0	47		F	01/30/2006	Admission date 1/13/2006 AIDP- Acute Inflammatory Demyelinating polyneuropathy. Information received from discharge summary states GBS, urinary incontience, fecal incontinence, decreased reflexes, asthenia, paresthesis. msv				Y	Y	6			Y	12/06/2005	01/11/2006	36	LP results showed Albumino-Cytologic Dissociation Information from discharge summary states abnormal CSF. msv	PUB	PVT	Rhinocort		Information from discharge summary states depression as part of medical Hx. msv			1						1	Asthenia; CSF test abnormal; Demyelination; Guillain-Barre syndrome; Hyporeflexia; Inflammation; Laboratory test abnormal; Paraesthesia; Polyneuropathy; Guillain-Barre syndrome; Injection site inflammation; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U1763AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB029BA~UNK~IM~RA~HEP A + HEP B (TWINRIX)~1|TDAP~SANOFI PASTEUR~C2384AA~UNK~IM~LA~TDAP (ADACEL)~1|FLU3~SANOFI PASTEUR~U1763A~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB0298A~UNK~~~HEP A + HEP B (TWINRIX)~2|TDAP~SANOFI PASTEUR~C2384A~UNK~~~TDAP (ADACEL)~2	USA	Hospitalisation	Influenza
0251835	02/24/2006	IL	57.0	57		M	02/02/2006	ITP, Platelet transfusion +. Information received from Discharge summry states thrombocytopenia. 60 Day Follow-up Information 12-May-2006: Lost contact.					Y				U	10/24/2005			Low Platelets	PVT	OTH		Asthma	H/O thyroid CA			1						1	Idiopathic thrombocytopenic purpura; Platelet count decreased; Thrombocytopenia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61123~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0251843	02/24/2006	CO	59.0	58		F	02/24/2006	24 yr old patient vaccination developed body aches, fatigue, headache, joint pain, stiffness, neck pain, low back pain, felt out of sorts light headedness, intermittent nausea, feels the same, sometimes worse 2 1/2 weeks post vaccination.									U	11/04/2005	11/05/2005	1		UNK	UNK	ibuprofen for root canal pain		Confirmed west nile case 2003, bronchitis sept 2005, root canal 11/11/05.		CO0506	1						1	Arthralgia; Back pain; Dizziness; Fatigue; Feeling abnormal; Headache; Joint stiffness; Nausea; Neck pain; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0251854	02/24/2006	CA	37.0	37		F	01/24/2006	Shot given and client states felt immediate intense sharp pain which continued until MD visit on 1/2/06. MD stated that bursa was possibly punctured from flu vaccination resulting in bursitis. Steroids given for 6 days in which pain subsided. Before medication client could not lift left arm above 45 degree angel. With medication client regained full ROM. Decreased strength which is slowly returning. On 1st day off med pain returned. Dr visit 1/10/06 and NASID given and MD stated to take indefinitely twice a day PRN for pain.				Y					N	11/08/2005	11/08/2005	0		OTH	UNK		NONE	NONE			1						1	Asthenia; Bursitis; Hypokinesia; Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~U1770AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0251855	02/24/2006	PR	44.0	44		M	02/18/2006	Skin rash severe Skin disorder, joint pain, night sweat. HBP, Headache.				Y					U	10/24/2004	02/15/2006	479		MIL	MIL	PPD					1						1	Arthralgia; Rash	ANTH~EMERGENT BIOSOLUTIONS~~6~~UN~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~3~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~4~~~HEP B (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~2~~~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0251856	02/24/2006	LA	1.37	1	.4	F	02/14/2006	C/O red leg, no pain. Apply cool compress. Call DR on Monday am. Per DR on call.									Y	02/06/2006	02/10/2006	4	NONE	PVT	PUB	NONE	NONE	Otitis Media, respiratory syncytial virus, Bronchiolitis.			1						1	Erythema	DTAPH~SANOFI PASTEUR~U10415C~4~~RL~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~U1917AA~3~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0300R~1~~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1114P~1~~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0251857	02/24/2006	GA	39.0	39		M	02/13/2006	Migraine headaches, dizziness, trouble sleeping, feeling sick, tired, muscle joint aches, memory problems, ringing in my ears, depressed, light hurting my eyes, high blood pressure, throwing up.				Y						03/16/2003	03/20/2003	4		MIL	MIL						1						1	Arthralgia; Depression; Dizziness; Hypertension; Insomnia; Malaise; Memory impairment; Migraine; Myalgia; Photophobia; Tinnitus; Vomiting; Chest X-ray; Chest discomfort; Chest pain; Chills; Dizziness; Dyspnoea; Fatigue; Feeling hot; Headache; Hypertension; Laboratory test; Migraine; Pyrexia	ANTH~EMERGENT BIOSOLUTIONS~~UNK~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1|ANTH~EMERGENT BIOSOLUTIONS~~1~SC~LA~ANTHRAX (BIOTHRAX)~2|HEP~UNKNOWN MANUFACTURER~~2~SC~~HEP B (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0251858	02/24/2006	IL	53.0	53		M	02/13/2006	Tetanus Diphtheria Decavac - left deltoid - sore arm. Flu injection right deltoid - unsettled stomach, lethargic, pain everywhere, inability to focus.									Y	01/24/2006	01/25/2006	1		OTH	PUB			Post Polio syndrome;Chronic demyelinating;Polyneuropathy			1						1	Depressed level of consciousness; Lethargy; Myalgia; Pain; Stomach discomfort	FLU3~SANOFI PASTEUR~U1849AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~AVENTIS PASTEUR~U1637BA~UNK~IM~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0251859	02/24/2006	IN	32.0	31		M	12/01/2005	C/O SOB and tachycardia shortly after receiving flu vaccine - went to ER - HR 120, BP 163/94. R 20 - placed on O2 - denied SOB, chest pain, labs drawn with EKLT. Accucheck 96 during MD eval HR increase 150, c/o weak, dizzy - 0920. HR 80's. referred to cardiologist  Echo (normal).				Y					Y	11/11/2005	11/11/2005	0	EKLT;BMP;UA;UDS;CBC;Troponin;CKMB;Thyroid Accucheck;TSH;Echo	PUB	PVT	Protonix 40 mg qd	NONE	Allergy PCN;GERD			1						1	Asthenia; Dizziness; Dyspnoea; Heart rate increased; Tachycardia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61128~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0251860	02/24/2006	ID	2.0	1	.9	F		Pt has seizures with nausea and vomiting.				Y					Y	02/14/2006	02/14/2006	0	CT Scan done-negative	PUB	OTH	NONE	NONE	NONE Information from medical records states convulsions as medical Hx. msv			1						1	Convulsion; Nausea; Stupor; Vomiting	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B006AA~4~~~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1743NA~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0251861	02/24/2006	MO	0.56	0	.6	M	02/10/2006	01-10-06 Mom called the clinic this AM to report patient had been taken to the ER at hospital after having a seizure. Mom reported 3 hrs after immunization a fever of 104. Medical records state irritability, Rhonchi. msv				Y					Y	02/09/2005	02/09/2005	0		PVT	PUB		Medical records state diarrhea at time of vaccination. msv	30 week former premie wt 3 lbs 2 oz.			1						1	Asthma; Convulsion; Irritability; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21005AA~2~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1787AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0287R~1~IM~RL~HEP A (VAQTA)~1|HIBV~MERCK & CO. INC.~0655R~2~IM~LL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~A25969B~2~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0251863	02/24/2006	MA	1.07	1	.1	F	12/28/2005	Fluvac- hives, temp - given Benadryl, given epinephrine right thigh. Projectile vomiting, bronchospasms. O2 SAT decrease, Tachycardia. Information received from medical records includes irritability, rhonchi. msv				Y					Y	12/19/2005	12/19/2005	0		PVT	OTH	Polycitra;Fluoride;Tylenol	Pneumonia Follow-up Dx 12/7/05 Information from Medical records states diarrhea as hx. msv	Renal Tubular Acidosis;Milk Protein Allergy			1						1	Bronchospasm; Haemoglobin decreased; Irritability; Pyrexia; Tachycardia; Urticaria; Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PNC~PFIZER\WYETH~~4~~~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0251864	02/24/2006	FL	43.0	42		M	01/19/2006	Severe pain at injection site. Right arm - arm was incapacitated. Pt stated he got weak and fainted. ER ov - Oxycodone, Percocet;IV.				Y					Y	11/10/2005	11/10/2005	0		PVT	PVT	Advair;Rhinocort;Advil;Singular;Proventil	NONE	Asthma;Rhinitis			1						1	Asthenia; Hypokinesia; Injection site pain; Syncope	FLU3~SANOFI PASTEUR~U1753AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0791P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0251865	02/24/2006	CA	0.61	0	.6	F	02/06/2006	Developed erythematous, pruritus papules over entire body/face after receiving second dose of influenza vaccine likely allergic reaction. Information received from medical records includes fever, vomiting, viral illness. msv									U	01/31/2006	01/31/2006	0		PUB	UNK		NONE	NONE			1						1	Erythema; Hypersensitivity; Pruritus; Pyrexia; Rash papular; Viral infection; Vomiting	FLU3~SANOFI PASTEUR~U1765GA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0251866	02/24/2006	VA	5.0	5		F		Rash, itching, hives									Y	01/27/2006	01/27/2006	0	NONE	PVT	PUB		Abdominal Pain				1						1	Pruritus; Rash; Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B002AA~5~~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1914AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0326~4~~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0234R~2~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0251867	02/24/2006	OH	11.0	11		M	01/25/2006	Client fainted app 5 minutes after receiving vaccine and hit his head on the floor. Client rested approximately 45 minutes but still felt weak. EMS called. On checking vital signs while standing client had seizure at approximately 10:30. Transported to hospital at 10:45 am.				Y					U	01/25/2006	01/25/2006	0		PUB	UNK	Mother states no other medication at home	Mother did not indicate any illness	Mother did not specify any diagnosis.			1						1	Asthenia; Convulsion; Syncope	FLU3~SANOFI PASTEUR~U1872AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0251869	02/24/2006	CT	1.04	1	.0	M	02/17/2006	Probable hemorrhagic edema of infancy 8 days after vaccine, parents state red eruption from feet to face - swollen feet (?tender); seen in office 6 days later with extensive ecchymoses.				Y					Y	02/02/2006	02/10/2006	8	PT;PTT;Platelets - Normal	PUB	PUB	Ferinsol	NONE	Anemia			1						1	Ecchymosis; Erythema; Oedema; Oedema peripheral; Rash	FLU3~SANOFI PASTEUR~U1787BA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0296R~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A56117D~4~~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0913R~1~~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0251870	02/24/2006	AZ	4.0	4		F	02/02/2006	Left deltoid skin reaction. Erythema and Edema. Benadryl 1 tsp q 4 hours. Motrin 2 tsp q 3 pm T hours or pain.										01/31/2006	02/01/2006	1	TB test 005N4P right forearm	PVT	PUB	NONE	NONE	Had 5mm hole in heart	~DTaP (Infanrix)~5~4.00~In Patient		1						1	Erythema; Oedema	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B008AA~5~~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1755AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB076AA~1~~RA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~Y0575~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0360R~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A25964D~3~~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0251873	02/24/2006	CA	38.0	37		F	01/27/2006	Approx 3-4 hrs after influenza vaccine, both eyes noted to be red - otherwise eyes asymptomatic. Later that evening, had tightness, difficulty breathing.									Y	01/03/2006	01/03/2006	0		PUB	UNK		NONE	NONE			1						1	Dyspnoea; Ocular hyperaemia	FLU3~SANOFI PASTEUR~U1828AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0251875	02/24/2006	GA	1.03	1	.0	M	01/27/2006	Red maculopapular rash all over body.				Y					Y	01/11/2006	01/23/2006	12	NONE	PVT	PUB	NONE		Anemia			1						1	Erythema; Rash maculo-papular	FLU3~SANOFI PASTEUR~U1788DA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0235R~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0445R~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0251876	02/24/2006	IL	3.0	2	.7	F	01/25/2006	Client was given MMR and Varicella vaccines using ActHib diluent. Incident occurred on 01/19/06.										01/19/2006				PUB	PUB		NONE	Diaper dermatitis			1						1	Medication error	DTAP~SANOFI PASTEUR~C2254AA~5~~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1803AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1045N~1~~RL~HEP B (RECOMBIVAX HB)~1|HIBV~SANOFI PASTEUR~UE415AA~4~~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0296R~1~~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0323R~1~~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0251878	02/24/2006	IA	47.0	46		M	01/31/2006	Left deltoid, red itchy, warm to touch and swollen. Distance line of where redness and edema stop. Used ice to site. Also stated had nausea/aching that lasted approx 12 hours.									Y	11/02/2005	11/02/2005	0		PUB	PVT	UNK	NONE	History of pneumonia			1						1	Cellulitis; Erythema; Feeling hot; Nausea; Oedema; Pain; Pruritus; Swelling; Feeling hot; Injection site erythema; Injection site pain; Injection site swelling; Malaise; Nausea; Pain; Pruritus	FLU3~SANOFI PASTEUR~U1761AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0529P~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U1761AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~649912/0529P~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0251881	02/24/2006	OH	45.0	45		F	02/01/2006	Within one hour of flu vaccine left arm painful. Deltoid had bruise and swelling. Pain had lasted and remains tender to touch.									Y	11/11/2005	11/11/2005	0	NONE	OTH	PVT		NONE	NONE			1						1	Contusion; Pain; Swelling; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61128~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0251845	02/25/2006	OR	5.0	5		M	02/24/2006	Approximately six hours after receiving the shot he developed a runny nose and congestion.  18-hours after the shot he developed a cough.  36-hours after the shot he began vomiting.  48-hours after the shot he developed a 103 degree temp.  He was given Robitussin for the cough, tylenol for the fever, Benadryl for the sinus and crackers, soup and liquids for the vomiting.				Y					U	02/22/2006	02/22/2006	0		UNK	UNK	none	none	Asthma			1						1	Cough; Nasal congestion; Pyrexia; Rhinorrhoea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0246582	02/27/2006	MA	56.0	55		F	02/22/2006	Initial report received from another manufacturer, report number WAES0511USA03757, on 15/Feb/2006. A 55 year old female patient, with a history of chronic bronchitis and high cholesterol, received on intramuscular, left arm injection of Fluzone SV 2005-2006, manufacturer lot number U1854AA; and an intramuscular, right deltoid second dose injection of Pneumovax 23, manufacturer, lot number 649693/0456P; on 26/Oct/2005. The patient reportedly received influenza vaccinations yearly. There was no illness at the time of vaccination. Fifteen minutes post-vaccination, the injection site, (specific site not reported), felt like a bee sting; and the upper arm was tingly, warm to touch, red, swollen and itchy. The arm began to hurt, and the patient complained of extreme pain at the injection site. She experienced a two to three inch circle of swelling and redness at the injection site, and the site was warm to the touch. Within two to three hours, the arm redness extended from the shoulder to the elbow. On the same day, the patient was examined in an emergency room and treated with prednisone, Atarax and a Medrol Dosepak. It was reported that the patient was diagnosed with a severe allergic reaction. No laboratory or diagnostic studies were performed. The patient recovered from the events on 30/Oct/2005. The reporter in this case considered the event to be an important medical event (OMIC). The reporter in this case is the same as for case 2006-00360.				Y					Y	10/26/2005	10/26/2005	0		UNK	UNK	Lipitor				200600361	1						2	Hypersensitivity; Injection site erythema; Injection site hypersensitivity; Injection site pain; Injection site reaction; Injection site swelling; Injection site warmth; Pain; Paraesthesia; Pruritus	FLU3~SANOFI PASTEUR~U1854AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0456P~2~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0252053	02/27/2006	NV		0	.0	M	02/27/2006	It started out with entire body going completely, while he made very tight fists with his hands and then would blank out and shake quite violently, these would last anywhere from 45 sec to an entire minute long.  There would be several of these episodes throughout the day!!  We only had one night in which this took place.  The started on the 12th of January 2006 and did not quit until the 23rd of January.  We never saw any signs that he would go into these at all nor were we sure of what kinda signs to be looking for... MY biggest fear was once he stopped shaking the blank stare would sometimes continue even with me calling his name, making loud noises around him etc.  Even touching him didnt work, he mainly had to come out of it on his own.				Y					Y	01/11/2006	01/12/2006	1	MRI, Cat scans, blood work and EEG's...All these results to date have come back NORMAL!!	UNK	UNK	NONE	NONE	NONE	Seizure activity~Influenza (Seasonal) (Fluzone)~2~0.60~In Patient		1						1	Coma; Loss of consciousness; Musculoskeletal stiffness; Staring; Tremor	FLU3~SANOFI PASTEUR~~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0252061	02/27/2006	IL	1.38	1	.4	M	02/27/2006	On 2/15/06 patient developed low grade fever and vomited X1.  On 2/16/06 no fever, had clonic-tonic, generalized seizure that lasted 3 minutes.  Paramedics found him post-ictal, afebrile; brought to ER where he had 2 more seizures, lasting 2 minutes.  Treated with Ativan & admitted to Ped Floor, where he was very agitated and had another seizure.  Treated with phenobarbital20 mg/kg & complete sepsis workup done.  Treated with Rocephin after spinal tap.  No more seizures and remained afebrile.  Patient returned to baseline, was playful, alert, feeding well & in no distress.  Remains on Phenobarbital and referred to Pediatric Neurologist and follow-up with pediatrician.  Discharged from hospital in stable condition.				Y	Y	2			U	02/14/2006	02/15/2006	1	Sepsis work-up done, including spinal tap, CBC, blood cultures and urine cultures.  All were negative.  CT of head with and without contrast was normal.  EEG results pending.	UNK	UNK	Cephalexin 250 mg/ml susp. 2.5 ml BID	Balanitis	None Information received from medical records states congenital heart problems, atrial septal defect. msv			1						1	Agitation; Convulsion; Postictal state; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1788AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0250177	02/28/2006	CT	50.0	50		F	01/16/2006	Initial report received from a Registered Nurse on 10/Jan/2006. A 50 year old female patient developed tingling and numbness in the left arm after receiving (latency not reported) the intramuscular injection of Fluzone, lot number U1778AA in the left arm on 10/Nov/2005. The patient had no illnesses at the time of vaccination and had received the flu vaccine previously. The patient was seen by a physician. Treatment provided was not reported. At the time of this report the patient had not recovered. Follow-up information received on 15/Feb/2006 from a health care provider. Per the reporter, the patient was hospitalized with neurological complications. The date of hospitalization was not reported. The date of vaccination has been amended to 09/Nov/2005, and the onset of the adverse events is reported as 2 weeks later. A consultation report from a neurologist is provided. The patient reported a tingling sensation in the feet and later in the hands two weeks following a flu shot. The left sided tingling was greater than the right, and she also experienced muscle twitching and an alteration in her voice. She subsequently experienced improvement, but has residual tingling in her left upper greater than lower extremity that remains. She also had 2-3 episodes of heart racing from sleep. She developed a red bumpy welt like rash on her left shoulder to back that has now resolved. Brain MRI of 20/Jan/2006 was unremarkable. C-spine MRI showed degenerative neurological examination, motor examination revealed a 5/5 strength in all groups. Tone was normal. No tremor was present. Gait was intact. Sensory examination is intact. Per the neurologist, the symptoms may represent a transient neuro-immunologic reaction to the flu shot or other neuro-immunologic entity. There is no imaging evidence of a central demyelinating process. However, she continues to experience subjective abnormal sensation over the left side of her body which could represent a resolving mild subacute demyelinating peripheral polyradiculoneuropathy. The patient was scheduled to received EMG/nerve conduction studies. At the time of this report, the patient had not recovered.					Y	0			N	11/09/2005				OTH	PVT	Calcium;Vitamins		The patient has received the flu vaccine previously. There was no illness at the time of vaccination and other medications were unknown. The patient has a history of bilateral femoral osteotomies for congenital hip dysplasia and has had breast biopsies. She has allergies to demerol and morphine.		200600081	1						2	Muscle spasms; Palpitations; Demyelination; Dysphonia; Erythema; Heart rate increased; Hypoaesthesia; Muscle twitching; Neuropathy peripheral; Paraesthesia; Rash; Urticaria	FLU3~SANOFI PASTEUR~U1778AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1778AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0252080	02/28/2006	OH	61.0	61		F	02/28/2006	Dx Brachial Neuropathy. Vaccine given 1/5/06. Pain at injection site eventually traveling down arm. Diffuse myalgia, vomiting 10 days later. Seen 1/27/06 with very tender shoulder. 2/16/06 and 2/17 visits showed 3/5 weakness, loss of sensation left arm. Given  Lyrica Mesic Ultracet. Information received from the annual follow up indicates patient has not recovered. Has continued LUE neuropathy with significant disablity. Difficulty working as hairdresser. Patient does not have insurance. Wants to know is there compensation available for her at least to cover medical costs? Lost contact with patient. Moved to California.								Y	U	01/05/2006	01/17/2006	12		PVT	PVT	Actos;Metformin;Glipizide		Diabetes;Chronic Abdominal Pain			1						1	Asthenia; Impaired work ability; Injection site pain; Myalgia; Neuropathy peripheral; Pain in extremity; Radiculitis brachial; Sensory loss; Tenderness; Vomiting	FLU3~SANOFI PASTEUR~U1872AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0252085	02/28/2006	TX	1.08	1	.1	M	02/20/2006	2-10-06 Pt received vaccine. 2 days later mother noticed urticaria - comes and goes with milk ingestion. Present today at clinic visit.									U	02/10/2006	02/12/2006	2		PUB	PUB	tylenol					1						1	Urticaria	FLU3~SANOFI PASTEUR~U1788FA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE688AA~4~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B17697E~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0252107	02/28/2006	DE	0.5	0	.5	M	02/21/2006	Had anaphylactic reaction approx half hour after pediarix #3, prevnar #3 and Flu #1. Swelling og face/ears/lips. Urticaria generalised. No tongue swelling and wheezing. Given epinepherinr IM, benadryl IV and solumedrol IV.				Y					Y	02/21/2006	02/21/2006	0		PVT	PVT	tylenol		eczema			1						1	Anaphylactic reaction; Face oedema; Oedema; Urticaria; Wheezing	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B037CA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1787DA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08642D~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0246284	03/01/2006	NE				U	02/22/2006	MEDI-0003701 is a non serious spontaneous case from a physician in the USA involving Redness Around The Nose: (Unlabelled USA). The reporter causality is not provided to FluMist. This case is submitted according to the VAERS Safety Surveillance accelerated reporting agreement for FluMist. A physician from a pediatric clinic reported that a child received FluMist in 2004 and later in the day experienced nasal congestion and redness around the nose. The patient completely recovered. No other information is available. The reporter causality is not provided. Vaccine was not administered at this facility and child has not been seen since then. Therefore, patient's date of birth; age at time of vaccination; adverse event onset date/time; lot number for vaccine and vaccine administration date/time are not available and not retrievable as per reporter.  1/5/10 follow up - Erythema facial (Erythema) Nasal congestion (Nasal congestion)									Y					PVT	OTH	Concomitant drug not reported				MEDI0003701	1						2	Erythema; Nasal congestion; Erythema; Nasal congestion	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3	USA		Influenza
0252101	03/01/2006	OK	1.05	1	.0	F	02/28/2006	Developed rash (hives), swollen eyelids.									Y	02/27/2006	02/28/2006	1		PVT	PUB			Birth mark on back			1						1	Eye swelling; Urticaria	FLU3~SANOFI PASTEUR~U188iAA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0827R~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0948R~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0252198	03/01/2006	MA	5.0			F	02/24/2006	Information has been received from a infectious diseases pediatrician concerning her 5 year old daughter who, at her 5 year old check-up, was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Concomitant vaccinations included a dose of influenza virus vaccine (unspecified) and a dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3 component vaccine (+) poliovirus vaccine inactivated (ver0) (+) tetanus toxoid (Pediarix). The pediatrician reported that after receiving the dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live her daughter went into anaphylactic shock. 911 was subsequently called to the child's pediatrician's office. It was noted that the child's face swelled around an oxygen mask and head such that her ears could not be seen. The patient was treated with epinephrine. The child was rushed to a hospital via ambulance, but it was not reported if she was kept overnight. Allergy testing revealed that the child had a severe allergy to gelatin. The child was noted to be recovered as she responded well to the epinephrine. Anaphylactic shock was considered to be immediately life-threatening. Additional information has been requested.			Y	Y					Y	10/28/2005	10/28/2005	0	Allergy test - severe gelatin allergy	OTH	OTH					WAES0602USA04263	1						1	Anaphylactic shock; Face oedema; Hypersensitivity; Hypoxia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A020AA~UNK~~UN~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~V1778AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0610P~UNK~~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Life Threatening	Influenza
0252212	03/01/2006	KY	0.57	0	.6	F	03/01/2006	Fluzone .25ml administered on 2-23-06 in office. No problems at that time. ON 2-28-06 Mom states infant awoke with droopy left eye and mouth.No change neurological noted. Came into office a few hours later and symptoms had almost completely resolved. No problems notes.									Y	02/23/2006	02/28/2006	5		UNK	UNK	Zantac .8 and Fluconozole		preterm infant with dx at birth of intraventricular hemorrhage Medical records state prematurity as part oif Hx. msv			1						1	Facial palsy	FLU3~SANOFI PASTEUR~u1938aa~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0252217	03/01/2006	CA	38.0	38		F	02/22/2006	Client started oral Typhoid on 1/27/06 and she noticed facial rash-little red bumps not itching in week of 1/30/06. No more rash by the week of 2/6/06. Follow-up Information 31-MAR-2006: Client did not know when this rash started, she noticed the rash on the week of 1/30/06. No date or time provided by client.									Y	01/25/2006			NONE	PUB	UNK		NONE	NONE			1						1	Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500394P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB036A~1~~LA~HEP A + HEP B (TWINRIX)~1|IPV~SANOFI PASTEUR~Y0324-2~UNK~~LA~POLIO VIRUS, INACT. (IPOL)~1|TYP~BERNA BIOTECH, LTD.~3000917~UNK~PO~MO~TYPHOID LIVE ORAL TY21A (VIVOTIF)~1	USA		Influenza
0252229	03/02/2006	MA	65.0	64		F	01/24/2006	Scratchy throat, congested, achy, puffy eyes.									Y	11/02/2005	11/02/2005	0		OTH	PUB	NONE	NONE	NONE			1						1	Eye swelling; Nasal congestion; Pain; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~UI854AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0252232	03/02/2006	VA	41.0	40		M	02/23/2006	Patient complains of soreness of left arm. Arm is warm to touch. VHC notified at 10:30. VHC provider evaluated patient and gave instructions: Alternate warm-cold compress for 48 hrs. Take Motrin for pain.									U	02/21/2006	02/22/2006	1		MIL	MIL	BP medicine		Diabetes			1						1	Myalgia	FLU3~SANOFI PASTEUR~U1882AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1044P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0252233	03/02/2006	NE	1.95	1	.9	M	02/15/2006	Developed cellulitis in L arm quarter size. 2/8/06 Dad called, son has cellulitis on L arm where Pediarix was given 10-31-05 given antibiotics, info given to Dr. 2-13-06 called Dr. she asked me to call dad and find out particular. Spoke with dad, son developed redness and cellulitis. The next day approx 1 1/2 months later after itching/digging at area he began to have a pus like discharge from L arm where inj. were given. Approx 2 wks later they took him to Dr and were told that it was cellulitis and he was placed on antibiotic course. That didn't seem to help so he was placed on another antibiotic, area is getting smaller. I have a call into Dr office to find out what antibiotics were given. VAERS report filed.				Y					Y	10/31/2005	11/01/2005	1	Culture - Negative	PUB	PUB	NONE	NONE	NONE		NE062	1						1	Cellulitis; Erythema; Pruritus	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B010AA~2~IM~LA~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1744AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A25962A~2~IM~RA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0252234	03/02/2006	NE	1.31	1	.3	M	02/15/2006	Developed cellulitis in RA < quarter size. 2/8/06 Dad called son has cellulitis where Pediarix was given on 1/11/06 given antibiotics info given to Dr. 2/13/06 Spoke with LPN, she asked me to call dad and find out particulars. Spoke with dad, states son had redness and swelling the day of the inj. They took him to see Dr 1 week later and was told it was cellulitis but not placed on antibiotic. Dad states area not any bigger. Will contact Dr to see what antibiotic he was placed on. Vaers report will be filed.				Y					Y	01/11/2006	01/11/2006	0	NONE	PUB	PUB	NONE	NONE		2/1/06~DTaP + HepB + IPV (Pediarix)~2~0.23~In Sibling	NE063	1						1	Cellulitis; Erythema; Injection site reaction; Swelling	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B010AA~2~IM~RA~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1881AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0480R~3~IM~RA~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~A98341B~3~IM~LA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0252257	03/03/2006	ID	54.0	54		M	03/02/2006	Developed severe nausea, vomiting and muscle aches 3-4 days after vaccine. ~1 week after developed severe dizziness, inability to focus, memory loss. Over the next months symptoms have improved slowly. Still complained of severe weakness and fatigue. Can only work 4 hrs day then has to rest.									N	10/27/2005	10/31/2005	4	All labs within normal limits	PUB	PUB		COPD, bronchitis, Ethohism				1						1	Amnesia; Asthenia; Dizziness; Fatigue; Myalgia; Nausea; Vision blurred; Vomiting	FLU3~SANOFI PASTEUR~U1903AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0748P~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0252275	03/03/2006	WA	8.0	8		M	02/27/2006	Left arm -local swelling 2cm x 2.5 cm area of induration									U	02/24/2006	02/25/2006	1	NONE	PVT	PUB		J Diabetes Mellitus	J Diabetes Mellitus			1						1	Injection site induration; Swelling	FLU3~SANOFI PASTEUR~41903AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0346R~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0252304	03/03/2006	CA	5.0	5		F	03/03/2006	Area of erythema and induration at Dtap site. Size 14 x 13 cm.									U	03/01/2006	03/02/2006	1		PUB	OTH		Asthma;ROM	Asthma			1						1	Injection site erythema; Injection site induration	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B006BA~5~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1914AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0638~4~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0301R~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0252305	03/03/2006	CA	51.0	51		F	02/10/2006	Info from patient: 51 year old healthy woman went Nov 16,2005, for a routine flu shot that was offered by Employee Benefits section of the County. She states that the injection was given very rapidly and with force that seemed like stabbing. This was much more forceful and fast than previous shots she had received. She had local soreness that day and then had increasing soreness and weakness of her left arm. She states that since then she cannot lift heavy items with that arm and sometimes her arm is so weak that she has trouble getting her arm into a sleeve. She states that the pain varies between discomfort and more severe pain and is sometimes up into her shoulder and down to her wrist. She was seen at the office of her primary care doctor in December, 2005. She reports that the doctor said her symptoms could be from the shot, or could be tendon damage but that there were no specific answers. Ibuprofen was prescribed. She will return to her doctor because she still has the weakness and pain as of January 27,2006.				Y					N	11/16/2005	11/16/2005	0		OTH	PVT	NONE	NONE	NONE			1						1	Discomfort; Hypokinesia; Muscular weakness; Myalgia; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61128~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0252300	03/05/2006	IL	67.0	67		M	03/05/2006	Patient experienced extreme myalgia in upper right leg which persisted for 48 hours, then the pain subsided very slowly over the next 4 days. This started 4 hours after administration of the vaccine. (The date of vaccination entered in Question 10  approximate, actual date was within 10 days of 10/18/2005)									Y	10/18/2005	10/18/2005	0	patient had an annual flu shot  for at least the previous twenty (20) years	UNK	UNK	Nexium, Maxzide-25					1						1	Myalgia; Pain	FLU3~SANOFI PASTEUR~U1854AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247166	03/06/2006	NE	85.0	84		F	03/03/2006	Initial report received from another company (reference number QAES0511USA00613) on 2/28/2006. This information was reported to the other company by a pharmacist. An 84 year old female patient with no reported medical history, had received an intramuscular injection of Fluzone SV 2005-2006 USP, lot number U1806AA, in the right deltoid and an intra muscular injection of Pneumovax 23, lot number 650453/0791P, in the left deltoid on 10/23/2005. The patients daughter called the pharmacist to report that on 10/24/2005, one day post vaccination, her mother developed redness and pain in the left shoulder where the Pneumovax 23 product was administered. the patient was treated with cold packs, ibuprofen and diphenhydramine hydrochloride (Benadryl). The pharmacist recommended that the patient should see her physician if the symptoms worsened. It was reported that the patient was hospitalized on the evening of 03/Nov/2005 with shortness of breath, rales and pneumonia.  The patient was released from the hospital the next day. It is unknown whether the patient had any illness at the time of vaccination. The patients recovery status was reported as unknown (also reported as not recovered). The pharmacist reported that he pulled all of his Pneumovax 23 vaccine off his shelf and requested a lot check be done. The records of testing prior to the release of the Pneumovax 23 lot were checked by the other company's Quality Assurance department and were found to be satisfactory. The lot complied with the standards of the center for biologics evaluation and research and was released.					Y	1			N	10/23/2005	10/24/2005	1		OTH	PVT					200600485	1						3	Injection site hypersensitivity; Injection site pain; Injection site reaction; Pneumonia	FLU3~SANOFI PASTEUR~U1806A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~0791P~2~IM~LA~PNEUMO (PNEUMOVAX)~3	USA	Hospitalisation	Influenza
0248060	03/06/2006	KS	48.0	47		M	03/02/2006	Initial report received on 11/22/2005 from a patient. A 47 year old male with a history of ragweed allergies received a left deltoid injection of Fluzone SV 2005-2006 USP, lot number U1830AA, on 11/4/2005 at 6:00pm. One hour later, he developed a severe headache and sore arm. he now complains of stiffness and aches in his left arm, neck, shoulder and down his mid back. An electrocardiogram, chest x ray and complete blood count are reported as within normal limits. There was no illness at the time of vaccination, and the patients medications include Flonase and allergra. He also receives allergy shots every two weeks. Per the reporter, the patients symptoms are persisting, and he has not recovered. Follow up information received on 2/27/2006 from a health care professional. Per the new information, the adverse events were updated. it was reported that the patient was also allergic to cotton and sea weed. Per the reporter, the route of administration of the vaccine was intramuscular. The event was described as severe headache, sore and stiff muscles of the arm and shoulder that extended down between the patients shoulder blades. This occurred one hour post vaccination. At an unspecified time later, he was seen by a physician and results of blood tests, chest x ray and heart monitor seemed okay. Per the wife, on the evening of the vaccination, the patient could hardly get upstairs as he was weak and short of breath. At the time of this report, the patient had been taking Prednisone for three days and had been taking a muscle relaxant for one week. It was reported that the patient had not recovered from these events at the time of this report.				Y					N	11/04/2005	11/04/2005	0		PUB	UNK	Flonase, Allegra, allergy injections.		There were no illnesses at the time of the vaccination. The patient is allergic to cotton, rag week and sea weed.		200502540	1						2	Asthenia; Dyspnoea; Headache; Hypokinesia; Musculoskeletal stiffness; Myalgia; Pain	FLU3~SANOFI PASTEUR~U1830A~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0252336	03/06/2006	PA	65.0			F	02/27/2006	Emergency nurse said erratic heart beat, in ER for about 2 1/2 hrs. Vaccine given and immediately had palpitations.				Y					Y					PUB	UNK		NONE	NONE			1						1	Heart rate irregular; Palpitations	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0252337	03/06/2006	VA	75.0	75		F	02/25/2006	On 10/18 her arm was painful, red and swollen. She also had fever, body aches throughout 10/18, 10/19, 10/20 & 10/21. She was also nauseous. When she presented to me on 10/21 her arm was red and splotchy. I referred immediately to MD and called MD and he prescribed Keflex. She also went to MD that night and he confirmed Cellulitis and said Keflex ok.				Y					Y	10/18/2005	10/18/2005	0		PVT	PVT	Betimol;Premarin; Chlordiazepoxide/amitriptyline	NONE	Allergy - Fluoroquinolones			1						1	Cellulitis; Erythema; Nausea; Pain; Pyrexia; Rash maculo-papular; Swelling	FLU3~SANOFI PASTEUR~U1747AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0791P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0252338	03/06/2006	MI	74.0	73		F	03/02/2006	Right arm (where shot given) starting to hurt immediately by time arrive home. Couldn't lift- ached continuously went back to Dr. He said not from shot - sent to phy therapy - arm still aches hurt to lift in certain positions.									N	10/18/2005	10/18/2005	0		PVT	UNK	Diovan;Lovastatin;Multi Vitamin;Baby Aspirin	NONE	Allergic to test dye;High Blood Pressure;Clost;Herpes			1						1	Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U1902AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0252344	03/06/2006	MD	1.0	0	1	M	02/24/2006	Vesicle in varies stages of healing on the body, arm, leg. No Tx.										11/21/2005	02/21/2006	92	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Blister	FLU3~SANOFI PASTEUR~U1935AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0295R~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A25969A~5~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0252357	03/06/2006	NY	63.0	63		F	03/06/2006	The injection was administered intramuscularly in the right deltoid using a 1 inch needle. The acromion process was palpated as site reference and injection given below acromion in dense portion of deltoid muscle. The site was visualized when patient presented to clinic today and was unremarkable. Patient reports pain and discomfort in right upper arm upon pressure and position changes. Pt relates discomfort to injection and has sought medical attention through two physcians. The initial provider was seen approximately one month ago and patient was treated with anti-inflammatory medication that produced no relief per patient. The second provider offered her a shoulder x- ray of which she declined.									N	11/30/2005	11/30/2005	0		UNK	UNK	hypertensive medication	none reported on adult immunization intake form	denies per adult immunization intake form			1						1	Discomfort; Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U1904AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0252378	03/07/2006	CA	9.0	9		F	03/03/2006	pt noted redness in LOA of left deltoid in evening of 3/1/06 day of administration. Swelling noted by mother on 3/2/06 redness had increased. Today 3/3/06 color and swelling subsiding. Child c/o some itching at site. Mother gave TYELNOL x 1 last evening. Child offers no other complaints, nor does mother. Child anxious to return to her school at this time.									Y	03/01/2006	03/01/2006	0	None	PVT	UNK		None	None			1						1	Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62447~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARCEL~MERCK & CO. INC.~0769P~1~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0252386	03/07/2006	NY	0.17	0	.2	F	03/02/2006	High pitch cry - 35 minutes.									Y	02/28/2006	02/28/2006	0		PVT	PVT	NONE	NONE	NONE			1						1	High-pitched crying	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~C21B053AA~UNK~~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UE809AA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08639A~UNK~~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0252412	03/07/2006	AR	3.0	3		F	03/07/2006	Two weeks after the flu shot, started having generalized mycloinc seizures and generalized convulsive seizures.  Three different anticonvulsants were tried, then IVIg was given to the patient. She is still having seizures not as many, but she must wear a helmet all the time. We are down to less than 5 a day. 3/31/2010 Follow up: The seizures stopped, but it is hard to tell if she has any mental deficis at this time.			Y	Y	Y	5			U	11/14/2005	11/29/2005	15	CT Scans showed no abnormality. Blood work showed no abnormality.  Video EEG performed at hospital captured Generalized Myclonic Seizures.  Patient had no prior health problems, no family history of seizure disorders, no mental degredation that would be associated with other known seizure disorders.  Viral exposure from the flu shot, was determined by doctors to be the cause of the seizures.	UNK	UNK	None	None The previous year, the flu shot was given in two doses, not just one.	None- was a normal vaginal deliery- 42 weeks gestation.  No health problems ever!!			1						1	Blood test normal; Computerised tomogram normal; Convulsion; Electroencephalogram abnormal; Immunoglobulin therapy; Myoclonic epilepsy	FLU3~SANOFI PASTEUR~U1871BA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0252426	03/07/2006	CT	49.0	48		M	03/07/2006	Pain at left upper arm and shoulder area when patient moves the arm above head or behind the back. Also experiences numbness in same location along with pain. These symptoms last about 2 minutes then resolve per the patient. Symptoms started about 2 days post vaccination. Patient has not received any formal treatment.									N	12/19/2005	12/21/2005	2	NONE	OTH	PVT	NONE		Raynaud syndrome, Allergy to Tobramycin	Same as current event~Influenza (Seasonal) (no brand name)~~42.00~In Patient		1						1	Hypoaesthesia; Hypokinesia; Injection site pain; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U1772AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0252433	03/08/2006	TX	56.0	55		F	02/22/2006	2/14/06 Pt felt nausea, vomiting, difficult swallowing and wheezingin the evening at 2000 hrs approx 10 hrs after vaccine (2/14/06 1035). Pt had expressed no allergy to eggs or problems with previous vaccination. 2/15/06 Pt reported ernesis/nausea that cleared up by mid-day.									Y	02/14/2006	02/14/2006	0	NONE	PUB	PUB		NONE	Penicillin (hives), Vicodin (hives), Parvocet (itching)		TX06012	1						1	Dysphagia; Nausea; Vomiting; Wheezing	FLU3~SANOFI PASTEUR~U1915AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0252434	03/08/2006	TX	40.0	39		M	02/22/2006	Fever 101-102, myalgias, swelling, redness moderate 8 cm diameter both deltoid for 5 days following immunization.				Y					Y	02/18/2006	02/18/2006	0	CBC, CXR	PVT	OTH	NONE	NONE	History Non Hodgkins Lymphoma s/p bone marrow transplant	swelling~Influenza (Seasonal) (no brand name)~1~0.00~In Patient		1						1	Erythema; Myalgia; Pyrexia; Swelling	DTAPH~SANOFI PASTEUR~U1397AA~1~IM~LA~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~U1870AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0324~3~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|PPV~MERCK & CO. INC.~0605R~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0252463	03/09/2006	VA	4.0	3		F	02/21/2006	Had 2 shots, one in each arm. Lt arm in morning, upper arm grew big, red/purple, swollen, itching, skin very dark in color. Only local itching. From shoulder to elbow Mom describes swelling. Seen by MD given cephalexin supervision. Mom reports arm smaller after medicine.				Y					Y	12/20/2005	12/21/2005	1	Will fax reports from hospital - have been requested. This is info from Mom.	PUB	PUB	NONE	NONE	NONE			1						1	Contusion; Pruritus; Skin discolouration; Swelling	FLU3~SANOFI PASTEUR~U1914AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A98341A~4~IM~RA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0252465	03/09/2006	GA	36.0	35		F	11/07/2005	Patient states she received the flu vaccine at 9AM.  Around 12 Noon she began to feel nauseated, had diarrhea felt dizzy and had hot flashes.  She left work and went home.  By 4PM that day she was feeling much better.  Did not go see a doctor.									Y	11/04/2005	11/04/2005	0		PUB	PUB		NONE	Hypertension		GS05043	1						1	Dizziness; Hot flush; Nausea	FLU3~SANOFI PASTEUR~U1804AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0252466	03/09/2006	GA	43.0	42		F	11/10/2005	Per patient approximately 3 hours after receiving flu vaccine, patient experienced uncontrollable shaking, fever 101 degrees lasting 1-1 1/2 hours.  Also nauseated, dizziness, severe aches in joints, felt like coming down with the flu.									Y	11/08/2005	11/08/2005	0	NO	PUB	PUB	Neutron, Phenergan	NONE	Breast Cancer 2 years ago.		GA05044	1						1	Arthralgia; Dizziness; Influenza like illness; Nausea; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U1914AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0252467	03/09/2006	OH	76.0	76		M	02/20/2006	Left arm was swollen from my shoulder to my wrist. For a week.				Y					Y	10/31/2005	10/31/2005	0		UNK	UNK		NONE				1						1	Oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0252468	03/09/2006	CA	47.0	47		F	03/06/2006	A couple hours after the flu shot, I felt pain at the site of the shot as well as a burning sensation in my fingers, upper and lower arm. This was accompanied a few days later by loss of motion and soreness. About 12 weeks later I was diagnosed with rotator cuff tendinitis. It has been treated with Aleve then with a cortisone shot.				Y					U	11/14/2005	11/14/2005	0	Check for range of motion in left arm, limited to 90 percent sideways, 30 back, 180 up.	PVT	PVT		NONE	Allergic to penicillin.			1						1	Injection site pain; Joint range of motion decreased; Pain; Rotator cuff syndrome; Skin burning sensation; Tendonitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0252469	03/09/2006	GA	70.0	70		F	03/03/2006	Sore arm since vaccine was administered. Woke up on 3/2/06 with pain in the shoulder and arm muscle. In arm vaccinated with the pneumococcal vaccine.									U	12/19/2005	03/02/2006	73		OTH	PVT						1						1	Injection site pain; Injection site reaction; Myalgia; Shoulder pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~139AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1046P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0252502	03/09/2006	TX	39.0	39		M	03/09/2006	This 41 year old received routine influenza, typhoid, and yellow fever vaccinations on 23 Feb 2004. He reported experiencing fatigue, muscle aches and bilateral arm soreness for two days following this group of vaccinations. He denied any fever, chest pain or breathing difficulty, nausea or vomiting.  He continued training which included shooting at the pistol range. He reported undergoing a dental procedure (tartar removal) without prophylactic antibiotics in December 2003 with a past medical history of heart murmur, GERD, mononucleosis as a teenager, and various orthopedic ailments (see past medical history below). He was questioning the association of Anthrax vaccine given 17 March 2003 and his endocarditis. [NOTE: 3/17/2003 AVA #1 marked DO NOT GIVE on one SF 601 and a PHS 731 form but entered into DEERS and onto DDF 2766 as given. No further AVA vaccinations documentated.] He was deployed one week later on 01 March 2004.  By 04 March 2004 he awoke feeling bad with severe thirst and feverish.  He reported to medical 6/7 March 2004 with persistent fevers, chills and maliase.  He was advised he may have the flu versus travel fatigue, given an unknown shot and prescribed Motrin. His symptoms persisted and worsened over the next few days. On 11/12 March 2004 he returned to the medical clinic and was administered 3 IV's as his hands and feet were yellow, had xrays and was advised he may have an STD or sinus infection.  He was treated for sinusitis and dehydration. His symptoms would begin to resolve only to relapse again.  On March 26, 2004 he again experienced reoccurrence of fevers, chills, nausea and vomiting, a non-productive cough without shortness of breath or chest pain.  He reported to clinic complaining of fatigue upon awakening, climbing a flight of stairs requiring him to sit down due to fatigue, and inability to do any physical training or stretching due to illness.  He denied any chest pain or shortness of breath but admitted he got winded with exertion. He had lost approximately 27 pounds (unintentinal) over the previous 2 months due to lack of appetite. He was drinking increased amounts of gatorade due to fevers. He considered low iron as possible cause for his fatigue and self-treated with vitamin B supplements, iron pills and ate leafy green vegetables.  He was treated with another course of antibiotics following normal laboratory studies.   By 25 April 2004 he had completed 14 days on Z-pak and was again ill with fevers, chills, nausea, vomitng, fatigue.  He complained of being sick as a dog.  He returned to the doctor for further evaluation and lab studies.  His labs from 25 April were repeated on 27 April due to inconsistency in lab data results. His ESR was now positive.  He was sent to a cardiologist on 28 April 2004 for cardiac evaluation and admitted with endocarditis for ten days.  Review of available medical records document in April 2004 an evaluation and subsequent admission for emergency suspicion of mitral valve endocarditis, mitral valve insufficiency third degree.  It was reported he complained of 2 month history of night sweats, fevers and shivering with considerable reduction in his physical efficiency/athletic abilities; treated for suspected sinusitis with bactrium then Zithromax without improvements. History of heart murmur for several years with tartar deposit removal 2 months ago without prophylactic antibiotics.  His exam showed pale skin color, ipsilateral vesicular breathing noise, tachycardia, loud systolics through all auscultations with a p.m. in IV, TCR left parasternal.  His color Doppler echocardiogram showed a 4.6 cm left auricle enlargement, clearly degenerated mitral valve with suspicion on the front mitral valve velum.  Left ventricle was enlarged end diastolic with 6.3 cm at above normal systolic function (EF 78%).  Mitral valve insufficiency III-IV was evident by coloor Doppler sonography with no pericardial discharge.  He was admitted, placed on oxygen for dyspnea, streptococci viridans was identified via blood cultures and he was given 1x10 mega-penicillin G IV antibiotics per day. A transesophageal echocardiography revealed a high degree of mitral valve insufficiency with tearing of chordae and slightly hardened mitral valve; physical exam documented a loud, holosystolic cardiac murmur radiating to all areas of the heart with a third heart tone auscultated in the diastolic region. Due to increasing heomdynamic impairment an Urgent mitral valve reconstruction was indicated.  He underwent mital valve reconstruction with a Medtronic Duran Ancor Ring 20 R (SN R49795, Diam 29mm) on 14 May 2004 without complications. He was treated with IV Vancomycin and Penicillin G then changed to oral Augmentin.  Follow up echocardiogram 21 May 2004 showed normal left ventricular function; mitral valve after annuloplasty and quadrangular resection of posterior velum showed a very good result, anterior velum is freely movable, posterior velum is very competent with normal gradient. He developed a thoracal pain syndrome due to previous left shoulder surgery treated with physiotherapy and medication.  He was discharge from hospital 25 May 2004 to a rehab hospital where he developed a drug-induced exanthema to Augmentin and was change to Elobact (Cephalosporin) which increased the allergic reaction. He was treated with IV Gentamicin then oral Sobelin (to take for 3 months) with no further adverse events. He also fell into post-op depression which resolved with 2 weeks of discussion therapy.  Follow up evaluation with cardiologists (July 04-Jan 05) documented h/o MVP with possible bacteremia exposure after a dental procedure without prophylactic antibiotics two months prior to onset of his endocarditis. He is s/p mitral valve repair in May 2004.  He is doing well since surgery doing light weight-training 3x/wk, and a total of 30 minutes of aerobic exercise (stationary bike, walking, elliptical machine) 2-3x/wk.  He denies any chest pain or unusual shortness of breath during exercise.  Two months ago, he had one episode of persistent tachycardia 1 hour after doing 10 laps in swimming pool, and denied any associated symptoms.  Three nights ago (1 Jan 05) he had five episodes of sudden onset of SOB as he fell asleep.  Sleeps on one pillow with no SOB while lying at this angle.  These episodes resolved spontaneously without recurrence.  He denied any lightheadedness or syncope since May 2004. Meds include ASA 81 mg, MVI, Tums prn.  His exam was normal with normal EKG biphasic P in V1-2 w/o ST elevation/depression, normal CBC, chol 232, Tg 265, HDL 40, LDL 139, Normal CXR w/MV prosthesis, TTE Aug 2004 LVEF 55-65% (see below results), GXT 3 Jan 2005 normal indicating no evidence of exertional cardiac ischemia.  Doctor notes indicated he was clinically doing well with no functional limitations. Recommendations were to continue annual routine cardiology follow up with annual ECHO not required.  He remains asymptomatic as of this interview 19 April 2005 and follow up contact in Jan 2006. Review of available medical records noted the onset and documentation in pre/post deployment forms 2004 for migraine headaches with recommendations for speciality evaluation 12/2004. No further evaluation or medical records are available to describe these headache.  These headaches were described as frontal aches that began in 3/2004 and were only monthly by 12/2004.  No further characteristics of these headaches were identified.					Y	5			Y	02/23/2004	03/04/2004	10	8/12/2004: Exercise Stress Test s/p MV repair, MEB evaluation, perform TTE: Summary: Left ventricular EF 55-65%, No SAM noted of MV anterior leaflet, the annuloplasty ring in MV annulus appeared normal.  Mild mitral stenosis, acceptable, left atrium mildly dilated, estimated peak pulmonary artery systolic pressure could not be determined due to incomplete TR Doppler. MV repair is adequate, no sig MR or MS. No previous study for comparison available. (see attached file) 1/05/2005: Exercise Stress Test: Exercised for 10 minutes into stage 4, 11 METs, 100% MHR with test stopped due to fatigue, no chest pain or shortness of breath. Resting ECG normal. Functional Capacity normal, HR appropriate, BP normal resting -blunted response, chest pain none, arrhythmias, no, ST changes: depression upsloping, none. Overall impression: normal stress test.   01-18 Jun 2004 (see attached files for full summary): normal CBC, lytes, FBS, Hg1AC, INR, PTT/PT, Lipids,Chem 18 with elev LDL 271 and Lipase 81,; CK 6/1/04 23, CRP 2.3.	MIL	MIL	MVI	denies dental procedure 1-2 months prior to vacc and endocarditis	MVP GERD			1						1	Anorexia; Bacterial infection; Blood iron decreased; Chills; Cough; Dehydration; Dyspnoea; Endocarditis; Fatigue; Laboratory test abnormal; Malaise; Myalgia; Nausea; Night sweats; Pain; Pallor; Pyrexia; Rash; Sinusitis; Tachycardia; Thirst; Vomiting; Weight decreased; Yellow skin	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~SANOFI PASTEUR~~UNK~~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|YF~SANOFI PASTEUR~~UNK~~~YELLOW FEVER (YF-VAX)~1	USA	Hospitalisation	Influenza
0246515	03/10/2006		15.0			M	01/30/2006	(OMIC) Initial report received on 11/30/2005. A 15 year old male patient with a medical history of asthma had received an administration route and site not reported of Menactra, lot number U1821AA and a flu vaccine (manufacturer, route, site and lot number not reported) on 10/21/2005. Three days later, on 10/24/2005 the patient developed Bells palsy. Testing was done for Lyme disease and it was negative. The patient had a clinic visit and he was improving on 10/31/2005. Follow up information received on 12/09/2005. On 10/21/2005, the patient was vaccinated with a intramuscular, unspecified arm injection of Menactra, lot number U1821AA and an intramuscular, right arm injection of Fluzone SV 2005-2006 USP, lot number U1850AA. On 10/24/2005 at 6:00pm, the patient developed numbness of his tongue and a headache. On 10/25/2005, he was examined by the school nurse and complained of numbness of the right side of his face. He was then examined by his physician and diagnosed with Bells palsy. There was no illness at the time of vaccination, and other medications include a Maxair inhaler.										10/21/2005	10/24/2005	3		UNK	UNK	Maxair Inhaler		The pt has a preexisting medical condition of asthma. He was taking Maxair inhaler at the time of the vaccination.		200502670	1						3	Facial palsy; Headache; Hypoaesthesia; Tongue disorder	FLU3~SANOFI PASTEUR~U1850AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~3|MNQ~SANOFI PASTEUR~U1821AA~UNK~IM~~MENINGOCOCCAL CONJUGATE (MENACTRA)~3	USA		Influenza
0252515	03/10/2006	CA	2.0	2	.2	M	02/10/2006	Vomiting, redness, and warmth at site - patient returned for follow up next day.  No treatment required. Per follow-up: Pt had local reactin to DTaP of flu shot. Reaction 2 1/2 x 2 1/2 inch L thigh. Area warm to touch.									Y	02/08/2006	02/09/2006	1		PVT	PUB		Croup				1						1	Feeling hot; Injection site erythema; Local reaction; Vomiting	DTAP~SANOFI PASTEUR~U1397BA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1787BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0560R~1~IM~RL~HEP A (VAQTA)~1|HIBV~SANOFI PASTEUR~UE782AA~4~IM~RL~HIB (ACTHIB)~1	USA		Influenza
0252544	03/10/2006	CO	48.0	47		M	03/10/2006	Pt received vaccine at approx 8:30am.  At approx 7:30pm she noticed hives on her lower torso.									Y	03/02/2006	03/02/2006	0		UNK	UNK		none	allergy to shellfish			1						1	Urticaria	FLU3~SANOFI PASTEUR~U1773AA~2~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U1576BA~2~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0252558	03/10/2006	MI	1.23	1	.2	F	03/07/2006	Child developed fever 103F within 24 hours of TIV vaccine. Dehydrated, vomiting and diarrhea. Hospitalized rehydrated and medicated. Rotavirus rule out.				Y	Y	1			Y	03/01/2006	03/02/2006	1		PUB	PUB	NONE	Information received from ER summry states fever, anorexia as symptoms at vaccination. msv	Oral Food a version;Hx of Roto virus infection			1						1	Dehydration; Diarrhoea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U1765FA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0252630	03/10/2006	OR	31.0			M	03/02/2006	This case was reported by a healthcare professional and described the occurrence of a body rash in a 31 year old male subject who was vaccinated with hep A vaccine (Havrix) for prophylaxis. Influenza vaccine given on 22Dec05; influenza virus vaccine; given on 22Dec05; polysaccharide typhoid vaccine; unk given on 22Dec05. Concurrent medications included Decavac. On 22Dec05 the subject received a dose of Havrix (dose and lot number not specified). Concurrently on the same date, the subject also received injections of influenza virus vaccine (Fluzone); polysaccharide typhoid vaccine (Typhim Vi) and DeCavac. On 24Dec05, two days after vaccination with Havrix, the subject developed a pinpoint non pruritic body rash. At the time of reporting the event was unresolved. The healthcare professional considered the event was possibly related to vaccination with Havrix.									N	12/22/2005	12/24/2005	2	UNK	OTH	OTH	Decavac (tetanus vaccine + diphtheria toxoid).	UNK	The subject's medical history, concurrent medications, and concurrent conditions were not reported.		A0587098A	1						1	Rash pruritic	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~RA~HEP A (HAVRIX)~1|TYP~SANOFI PASTEUR~~UNK~~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0252811	03/10/2006	NY	18.0	18		M	11/28/2005	Case received from a healthcare professional on 20Oct05. A 18 year old male pt without relevant medical history had received his first IM injection of Menactra, batch number U1808AA and an IM dose of Fluzone, batch number U1753AA on 18Oct05 and within a few hours later, he developed high fever at 102, shaking and chills. The pt required doctor visit. He received acetaminophen (Tylenol). The fever decreased and the pt was better. However, he was not completely recovered at the time of the report. The pt had no known allergies but experienced high fever after his second dose of hep B vaccine. He did not present with any illness at time of vaccination and did not take medicines. Follow up information received from a health care provider on 28Nov05. There was no illness at the time of vaccination. At the time of this report, the pt had recovered. Further information is not expected.				Y					Y	10/18/2005	10/18/2005	0		PVT	PVT			The pt had no known allergies but experienced high fever after his second dose of hep B vaccine. He did not present with any illness at time of vaccination and did not take medicines.		200502165	1						1	Chills; Pyrexia; Tremor; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U1753AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1808AA~1~IM~~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0252648	03/13/2006	AL	0.81	0	.8	M	03/07/2006	Started fever on 02/28/2006 Mom called and reported still had fever on 3/3/06. Tylenol controlled fever. No local rxn. 3/4/06 developed a rash, fever gone, poss roseola.									Y	02/27/2006	02/28/2006	1	NONE	PVT	PUB	Zantac	NONE	NONE			1						1	Pyrexia; Rash; Roseola	FLU3~SANOFI PASTEUR~U1788AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0252649	03/13/2006	NH	59.0	58		F	03/06/2006	Pt reports redness, swelling, pain at site. Also reports nausea and vomiting since she received medication (vaccine). Pt has been using Tylenol for pain.									Y	02/28/2006	02/28/2006	0	NONE	PVT	PVT	Lisinopril, Pravastatin, Lantus Insulin, Zetia	NONE				1						1	Injection site erythema; Injection site oedema; Injection site pain; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U1824AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1117R~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0252663	03/13/2006	GA	1.02	1	.0	F	03/10/2006	Papules, vesicles, scabbed vesicles 50 on legs trunk and face. Dx: chicken pox post vaccination. Tx: Acyclovir.				Y					Y	11/18/2004	02/20/2006	459	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Blister; Rash papular; Viral infection	FLU3~SANOFI PASTEUR~U1437AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1069N~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0273P~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0252689	03/13/2006	SC	48.0	48		F	03/13/2006	11-5-05:  Flu vaccine at flu clinic and worked in yard. 11-7-05:  Complained of aches, pains, tingling, numbness and heat all over  - down spine and down to right major toe, right thumb, left shoulder, but mainly in her neck and spine. 11-17-05: Saw family doctor and was referred for MRI of neck and had blood test.  Put on anti-inflammatory meds and Aciphex 11-23-05: Referred for MRi of thoracic region. 12-01-05: Family doctor referred patient to neurologist for evaluation of arachnoid cyst and disc problem in neck. 12-05-05: Saw neurologist who told her about cyst on spine and that the flu shot or any shot can cause neuralgia. Referred her to a neurosurgeon and placed on muscle relaxant. 12-13-05: Saw neurosurgeon.  He told her the cyst may have been there since birth or from an accident and they would just monitor it.  The neuralagia was from inflammation and he felt that it was from the flu vaccine.  Patient is concerned and does this mean that she should not get anymore flu shots in the future? and she wants to know if anyone else has ever had this happen to them?				Y					Y	11/05/2005	11/07/2005	2		UNK	UNK	NONE	NONE			SC0604	1						1	Cyst; Feeling hot; Hypoaesthesia; Neuralgia; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U1823AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0252693	03/13/2006	NC	26.0	26		M	03/13/2006	RECEIVED BOTH SMALLPOX AND INACTIVATED INFLUENZA VACCINES ON 11/18/2005.  HE PRESENTED TO THE VACCINE HEALTHCARE CENTER ON 12/01/05 FOR EVALUATION OF FATIGUE, FEVERS, POOR SLEEP, LEFT SHOULDER PERSISTENT PAIN, AND CONCERNS REGARDING HIS INOCULATION SITE.  THE PATIENT WAS EXAMINED AND FOUND TO HAVE AN ORAL TEMPERATURE OF 99.2F.  HE DID APPEAR FATIGUED.  HE WAS DIAGNOSED AS HAVING A ROBUST REACTION AND SENT HOME ON CLARITIN, MOTRIN, AND LIDEX CREME. THE PATIENT CONTINUED WITH FATIGUE ON THE FOLLOWING TWO DAYS BUT NEVER COMPLAINED OF CHEST PAIN OR SHORTNESS OF BREATH. THE PATIENT WAS FOUND DECEASED IN HIS BARRACKS BED ON THE MORNING OF 12/04/05. ACLS PROTOCOL WAS INITIATED IN THE FIELD AND CONTINUED IN THE HOSPITAL EMERGENCY ROOM TO NO AVAIL.   THE PATIENT WAS PRONOUNCED DEAD AT 0933 HOURS. THE PATIENT'S INITIAL AUTOPSY WAS NEGATIVE FOR ANY SIGNS OF FOUL PLAY, FRACTURE, ACUTE INJURY, TRAUMA, ALCOHOL OR ILLICIT DRUG INTOXICATION OR OVERDOSE. 8/3/06 Received medical records & autopsy report which stated COD as hypersensitivity myocarditis.  Final autopsy diagnoses also include sudden death in apparent healthy 26 year old; history of recent smallpox & flu vax; lymphocytic eosinophilic myocarditis, pulmonary edema.	Y	12/04/2005							N	11/18/2005	11/28/2005	10	1)URINE TOXICOLOGY IS NEGATIVE FOR DRUGS OF ABUSE. 2)AUTOPSY SERUM TOXICOLOGY IS NEGATIVE FOR DRUGS OF ABUSE. 3)CBC IS NEGATIVE FOR SIGNS OF ACUTE BLOOD LOSS WITH A NORMAL HEMOGLOBIN AND HEMATOCRIT.	MIL	MIL	CLARITIN 10 MG QD PRN (DISPENSED 12/1/05) MOTRIN 800 MG TID PRN PAIN (DIPSENSED 12/01/05) LIDEX CREME 0.05% (DISPENSED 12/1/05).	NONE	MEDICAL CONDITIONS: ASTIGMATISM, FLAT FEET NKDA			1						1	Fatigue; Injection site pain; Laboratory test abnormal; Myocarditis; Pulmonary oedema; Pyrexia; Shoulder pain; Sleep disorder; Sudden death; Cardiac disorder; Eosinophilia; Medication error; Pericarditis; Viral infection	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4020072~1~~LA~SMALLPOX (DRYVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~2	USA	Results in Death	Influenza
0251579	03/14/2006	TX	56.0	56		M	03/08/2006	Patient developed myalgia, severe joint pain, fever and exaggerated immunologic response.  ESR increased to 70, anemia				Y					Y	11/01/2005	11/04/2005	3	Elevated ESR, liver Enzymes, CMF	PVT	PVT	WARFARIN, Levoxyl, Diovan, Aldactone, Coreg, Lasix	Heart Disease, Hypothyroid.	Severe arteriosclerosis, Heart Disease, Graves Disease, S/P CABG			1						2	Albumin globulin ratio abnormal; Arthralgia; Blood albumin decreased; Blood alkaline phosphatase increased; Blood chloride decreased; Blood chloride increased; Blood cholesterol decreased; Blood creatinine increased; Blood glucose increased; Blood sodium decreased; Blood urea increased; Discomfort; Haematocrit decreased; Haemoglobin decreased; Laboratory test abnormal; Lymphopenia; Monocytosis; Myalgia; Pain; Platelet count increased; Pyrexia; Red blood cell count decreased; Red blood cell sedimentation rate increased; White blood cell count increased; Arthralgia; Immune system disorder; Laboratory test abnormal; Myalgia; Pyrexia; Red blood cell sedimentation rate increased	FLU3~SANOFI PASTEUR~U1903AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1903AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0252727	03/14/2006	MI	22.0	22		F		Rx axillary lymph node swelling and rt arm discomfort. Cellulitis requiring hospitalization and IV-ABX sent home with picc line and IV-ABX developed clots hospitalized again. Dc'd with PO ABX and Coumadin. DVT's L arm Discharge summary states synovitis. msv				Y	Y				Y	02/13/2006	02/14/2006	1		PVT	UNK			Rheumatoid Arthritis, Autism Discharge summary states allergy, otitis media. msv			1						1	Cellulitis; Injection site pain; Lymphadenopathy; Synovitis; Thrombosis; Cellulitis; Injection site abscess; Injection site reaction	FLU3~SANOFI PASTEUR~U1858EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0740R~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0740R~UNK~~UN~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0252746	03/14/2006	SC	38.0	38		M	03/08/2006	Pneumonia - Admitted to hospital 2/21/05 with hypoxemia and LLL pneumonia. Tx with tequin, rocephin, azithromycin, augmentin. Discharged 2/23/05. Influenza A & B - symptoms started > 5 days prior to hospitalization, so no antiviral rx. started. Discharge summary states hypokalemia dehydration. msv				Y	Y	2			Y	01/08/2005	02/13/2005	36	Medical records state leukocytosis, hypocalemia, hyponatremia. msv	MIL	MIL	Potassium		Episodic low back pain			1						1	Dehydration; Hypocalcaemia; Hypokalaemia; Hyponatraemia; Hypoxia; Influenza like illness; Leukocytosis; Pneumonia	FLUN3~MEDIMMUNE VACCINES, INC.~500357P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0252748	03/14/2006	MI	5.0	5		M	03/08/2006	Large area of erythema at site of immunization L upper arm.									Y	03/06/2006	03/07/2006	1		PVT	PUB	Flovent;Singulair	NONE	NONE			1						1	Injection site erythema	DTAP~SANOFI PASTEUR~U1615~5~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U18720AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0576~4~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0302R~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0252749	03/14/2006	CA	15.0	14		M	02/17/2006	2/16 11:30 a.m. shots received. 2/17 2 a.m. fever, chills, vomiting. Today with both eye swelling, HA, dizziness, decrease po. Pt arrived from out of the country 2 days ago. Pt temp 100.9, B/P 107/76, Pulse 127 done by MD.				Y					U	02/16/2006	02/17/2006	1		PUB	OTH	Aspirin	NONE				1						1	Chills; Dizziness; Eye swelling; Headache; Pyrexia; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62758~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVA03AA~1~IM~LA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U1822AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2340AA~6~IM~RA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~0431R~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0252750	03/14/2006	TN	11.0	11		F	01/31/2006	Anaphylactic reaction. BP 98-70, P 92. Pale, clammy, lethargic, throat constriction. Epi-Jr. 0.15mg given. 911 called. Taken to Hosp via rural metro ambulance.				Y					Y	01/31/2006	01/31/2006	0	Blood Glucose -93	PUB	PUB	Synthroid 100 mcg HS		Hypothyroidism		TN06004	1						1	Anaphylactic reaction; Lethargy; Pallor; Throat tightness	FLU3~SANOFI PASTEUR~U1915AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~AVENTIS PASTEUR~U1584BA~UNK~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0252751	03/14/2006	TN	3.0	3		F	01/26/2006	Fluzone vaccine administered 1-25-06 a.m. 2:00 p.m. child started to itch from her head, chest, back and ears, Mother described it as a slightly raised pink rash. Child is playing eating and sleeping but continues to scratch next day.									U	01/25/2006	01/25/2006	0		PUB	PUB					TN06003	1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U1755A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0252757	03/14/2006	HI	56.0	55		F	03/14/2006	Received shot and that night about 2 am woke up with extreme joint and muscle pain everywhere unable to stop the pain, it was so  extreme I was on the floor crying, My husband had to help me out of bed. This pain traveled throughout my body and I was unable to raise my arms from my side as well as my legs didn't work either all with lots of pain. My muscles jerk and some times have no energy to even stand up. My doctor ran every test there was to rule out Lupus, RA, Tumors and other stuff, all negative, he did say that he thought it to be Serum Poisoning. From the Perservative in the flu shot, Thimerosal. I have been so sick ever since. I have not worked, unable to clean my house or cook, watch my grand child, my life stopped, and I had to take drugs around the clock even writing every dose down so I would not over dose. Had to take Zoloft ( never took this before) Pain killer Ultram, IB 800mg. Plus many vitamins and detox, Chiropractors, accupucture, Lotions. I've spent alot of money to get this out of my body and get my life back, but they said it would take about 6 months and it has been 5 and I can finally think enough to write this down. I walked the floor at nights to just ease the pain so not much sleep I thought I was losing my mind. I'm still on the drugs but better then before. My mind forgets lots of things that happened I have to ask my family. This is something I will never do again, I will just have to die from the flu if thats the case, it would be quicker.				Y					N	10/24/2005	10/25/2005	1		UNK	UNK	Levoxyl 150mcg 1x Progesterone 100mg 1x	Knee pain from injury	Graves Disease/ take thyroid meds.			1						1	Arthralgia; Crying; Dyskinesia; Myalgia	FLU3~SANOFI PASTEUR~~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0252761	03/14/2006	AL	24.0	24		M	03/14/2006	DEVELOPED ACUTE LEFT SIDED CHEST PAIN ON THE MORNING OF FEBRUARY 28, 2006. THE PATIENT WAS ASLEEP AT THE TIME THE PAIN DEVELOPED.  THE PAIN WAS ASSOCIATED WITH NAUSEA AND DIAPHORESIS BUT NO VOMITING. THE PATIENT WAS TAKEN TO SICK CALL BY THE SICK CALL VAN AND SEEN BY THE PHYSICIAN'S ASSISTANT.  THE PA REFERRED THE PATIENT IMMEDIATELY TO THE EMERGENCY ROOM FOR EVALUATION.  THE PATIENT WAS SEEN ON 2/27/06 FOR TONSILLITIS AND DEHYDRATION.  HE WAS TREATED IN THE THE CLINIC WITH A FEW LITERS OF IV FLUIDS AND IV BICILLIN WITH GOOD RESULTS.  THE PATIENT WAS FOUND TO HAVE AN ABNORMAL EKG WITH WIDESPREAD ST ELEVATION, RIGHT AXIS DEVIATION, CONSIDER PERICARDITIS.  HIS PAIN RESOLVED AFTER ONE SPRAY OF NITROGLYCERIN.  HIS OTHER LABS REVEALED ELEVATED CARDIAC ENZYMES AND TROPONIN. HE WAS ADMITTED TO THE TELEMETRY WARD FOR TREATMENT AND OBSERVATION.  THE PATIENT MADE GOOD PROGRESS AND WAS FOUND SUITABLE FOR DISCHARGE ON MARCH 2, 2006. 05/08/06--8 page medical record received. In addition, a completed VAERS form included as 2 page correspondence. LOS 2/28-3/2-DC DX-acute myopericarditis-with abnormal EKG (non specific ST depression, right axis deviation, widespread ST elevation, elevated cardiac enzymes (positive CPK and troponin and chest pain. HX of asthma. patient will receive permanent exemption status from future smallpox vaccination.					Y	3			Y	02/16/2006	02/28/2006	12	1-EKG-NSR, RATE 95,NOSPECIFIC ST DEPRESSION, RIGHT AXIS DEVIATION, WIDESPREAD ST ELEVATION, CONSIDER PERICARDITIS. 2-CPK 1777, CPK-MB 107.2, TROPONIN 2.05 3-CHEST X-RAY: NORMAL LUNGS WITH NO ACTIVE DISEASE 4-NORMAL ECHOCARDIOGRAM 5-NEGATIVE URINE DRUG SCREEN 6-CBC WITH WBC ELEVATION OF 14.4K BUT NORMAL HGB/HCT AND PLT COUNT.	MIL	MIL	NONE	NONE	MEDICAL PROBLEMS: ASTHMA NKDA			1						1	Chest pain; Dehydration; Electrocardiogram abnormal; Enzyme abnormality; Hyperhidrosis; Nausea; Pericarditis; Tonsillitis	ANTH~EMERGENT BIOSOLUTIONS~FAV096~1~UN~UN~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~3~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~SMITHKLINE BEECHAM~AHBVB171AA~3~UN~UN~HEP B (ENGERIX-B)~1|SMALL~PFIZER\WYETH~4020072~1~ID~UN~SMALLPOX (DRYVAX)~1|TYP~PFIZER\WYETH~Z02762~1~UN~UN~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0252819	03/15/2006	CO	50.0	50		M	03/08/2006	Received flu vaccine 2/1/06. Developed localized soreness to right arm at injection site. Flu symptoms started 2/3/06 fever, achiness, chills. Illness continued through 2/9/06 then started feeling better. Awakened early am 2/12/06 with swelling and pain whole right arm. Treated initially with antibiotic and later with anti inflammatory.				Y					Y	02/01/2006	02/12/2006	11	Initially saw his personal MD and was prescribed antibiotic. Later saw workman's comp MD and had a Doppler exam to right arm which was normal.	OTH	UNK	NONE	Low grade temp week prior to flu shot.	NONE			1						1	Chills; Influenza like illness; Injection site pain; Malaise; Oedema; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1773AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0252820	03/15/2006	OH	70.0	70		F	03/12/2006	Pain in arm toward shoulder and down toward elbow left. Arm gets weak with internal vise like squeezing, similar to a blood pressure cuff action. Red rash from wrist up to shoulder, internal itching, symptoms still in arm.									U	11/17/2005	11/20/2005	3		PUB	PVT	Pravachol, Buspar, Vit E.	NONE	NONE			1						1	Asthenia; Erythema; Injection site pain; Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0252848	03/16/2006	WA	5.0	5		F	02/22/2006	Lt arm redness/warmth/swelling form deltoid to elbow, with elbow effusion. Was admitted and treated for cellulitis. - 4/13/06 Review of 11-page d/c summary confirms diagnosis of cellulitis and a secondary diagnosis of viral syndrome. Initially had a fever of 101 and vomiting.  She was treated with IV antibiotics and prescribed Keflex PO for 7 days after. Date of immunization should be changed to 02/17/2006. Additional vaccines given that day include PPV (Merck, 0746P, right arm) and flu (AP, U1868AA, right arm).				Y	Y	2			Y	02/17/2006	02/17/2006	0		PVT	PUB	Amoxicillin	Sickle Cell Disease - not sick	Sickle cell disease			1						1	Cellulitis; Injection site hypersensitivity; Injection site oedema; Injection site warmth; Joint effusion; Pyrexia; Viral infection; Vomiting	FLU3~SANOFI PASTEUR~U1868AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~SANOFI PASTEUR~UE485AA~1~IM~LA~MENINGOCOCCAL (MENOMUNE)~1|PPV~MERCK & CO. INC.~0746P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0252860	03/16/2006	TX	1.13	1	.1	F	03/07/2006	Dx: Varicella- rash,itching-Benadryl 12.5/5 3/4 tsp q 6 hours prn-Caladryl prn.									Y	11/19/2003	03/06/2006	838		OTH	UNK	NONE	UNK	NONE			1						1	Drug ineffective; Pruritus; Viral infection	FLUX~UNKNOWN MANUFACTURER~~1~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~1~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~~1~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0252882	03/16/2006	NY	52.0			M	03/16/2006	52 year old man with a history of Hodgkins disease and T cell, B cell rich lymphoma, coronary artery disease, valve replacement, developed thrombocytopenia approximately one week after recieving influenza vaccine (2005/6).  The patient presented to our urgent care with a platelet count of 9.  Patient experienced dyspnea & elevated BP.  Patient received IVIG, platelet transfusions and was put on prednisone. Discharge summary states idiopathic thrombocytopenia purpura. msv				Y	Y				Y	11/10/2005	11/18/2005	8	Platelet count on 11/18/05: 9K Platelet count on 11/10/05: 178K Discharge summary states abnormal lab tests. msv	UNK	UNK	Atacand 8 mg (first dose on 11/10/05)case reports also associate thrombocytopenia with atacand) Atenolol 25 mg Aspirin 325 mg	History of Hodgkins disease and T cell, B cell rich lymphoma.	Discharge summary states hypertension, aortic valve repoacement, coronary artery disease, hypercholesterol, Hodgkins, thyroid nodule. msv			1						1	Blood pressure increased; Dyspnoea; Laboratory test abnormal; Platelet count decreased; Platelet count increased; Thrombocytopenia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA145AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0252968	03/20/2006	NM	1.01	1	.0	M	03/14/2006	10 days after vaccine, patient broke out w/full blown measles rash, from head to toe. Fever ranging from 101.0-104.3 non-stop crying, lethargic, refused to walk, eyes irritated him severely. Lasted 5 days. Prescribed Benadryl and Motrin. 3/21/06 Received medical records from PCP which revealed patient experienced rash, fever & swollen lymph glands/ss			Y	Y					U	02/16/2006	02/26/2006	10		PVT	OTH			RSV treated w/Prednisone and Albuterol 12-16-05.	Fever~DTaP (no brand name)~~0.00~Sibling|~DTaP (no brand name)~~0.00~Sibling		1						1	Crying; Difficulty in walking; Drug ineffective; Eye irritation; Lethargy; Pyrexia; Rash morbilliform	DTAP~SANOFI PASTEUR~C2254AA~4~UN~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U1938AA~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0718R~4~UN~RL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0487R~1~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08640H~4~UN~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0914R~1~UN~LL~VARICELLA (VARIVAX)~1	USA	Life Threatening	Influenza
0252969	03/20/2006	OH	47.0	46		M		Pt was given influenza vaccine and pneumococcal vaccine 3/13/2006 prior to discharge from hospital. He came to the ED 3/15/06 @ 5:39 with a swollen face he was given Benadryl and Prednisone.				Y	Y				Y	03/13/2006				UNK	UNK		Asthma, recovering pneumonia, bronchitis, hypertension	Information received from ER summary states cerebral palsy as Health HX. msv			1						1	Face oedema	FLU3~SANOFI PASTEUR~U1762AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1117R~UNK~SC~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0252970	03/20/2006	TX	65.0	64		F	03/08/2006	Beginning 3/1/06 swelling and redness of L arm at location of pneumococcal polysach vaccine. Fever and headache started 3/1/06. Fever cont'd thru 3/4. Headache persist, L arm pain persists as of 3/8/06.				Y					U	02/28/2006	03/01/2006	1	Ultra sound of L upper arm.	PUB	PUB	KCL;Estratest HS;ACIP;Maxite;CA;Metamucil	NONE	HTN		TX06015	1						1	Headache; Injection site hypersensitivity; Injection site swelling; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1915AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577R~1~SC~LA~PNEUMO (PNEUMOVAX)~1|TD~AVENTIS PASTEUR~U1596DA~UNK~~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0253015	03/20/2006	CA	23.0			M	03/20/2006	Patient complained of left arm pain that radiated down left shoulder in between the biceps and triceps muscles and down the extensor surface of the forearm into the left hand following administration of a flu shot.									Y	12/14/2005	12/15/2005	1	Neurology referral after rest and NSAIDS not helpful. EMG normal.  Ortho eval. of shoulder. Pt. has transferred so patient and health record are unavailable for information.	MIL	MIL						1						1	Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0253078	03/21/2006	NY	55.0	55		F	03/20/2006	This case was reported by a nurse and described a 55 year old female subject who was inadvertently vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. Medical history included diabetes and one-half pack a day smoker. On an unspecified date in November 2005, the subject received an injection of influenza virus vaccine (unknown manufacturer). On 06 February 2006 the subject inadvertently received a dose of Fluarix (lot AFLUA132EA). This represents 2 separate immunizations for influenza in the same flu season. It is recommended to administer one dose of Fluarix annually. On 07 February 2006, the subject experience arm pain and arm redness. The events resolved on 27 February 2006. The nurse consider the events to require intervention or to jeopardize the subject. The nurse consider the arm pain and redness to not be related to vaccination with Fluarix.									Y	02/06/2006	02/07/2006	1		PVT	PVT			Diabetes, smoker. The subject's concurrent conditions and concurrent medications were not reported.		A0593906A	1						1	Injection site erythema; Injection site pain; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA132EA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0253146	03/23/2006	OH	36.0	36		F	02/14/2006	Palpations. Sinus tachycardia. Systemic reaction to flu shot.				Y					Y	12/09/2005	12/09/2005	0	EKG, Echdoppler, labs, chest x-ray	PUB	PVT						1						1	Chest X-ray abnormal; Electrocardiogram abnormal; Laboratory test abnormal; Medication error; Palpitations; Sinus tachycardia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~62759~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0253147	03/23/2006	GA	66.0	66		M	03/13/2006	Patient called today (3/13/06) and complained that right arm was sore. He had flu shot on 11/03/05. Said it started several weeks after vaccination.									Y	11/03/2005	12/05/2006	397		OTH	PVT						1						1	Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~142AA~1~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0253169	03/23/2006		67.0	67		F		A report was received from a healthcare professional on 3/14/2006, regarding a 67 year old female vaccinee. No details were provided regarding the vaccines medical history or concomitant medication. On 11/17/2005 the vaccinee received a 0.5 ml Fluvirin vaccination in the deltoid. On 11/25/2005, 2 weeks of receiving the flu shot the vaccinee visited her doctor with symptoms of positive body aches, headache and swelling in right let. The symptoms had started after vaccination and the vaccinee self medicated with Advil for the pain. A diagnosis of acute rheumatoid arthritis was made. The vaccinee had no incidence of arthritis before the vaccination. The vaccinee had lab work performed (details not provided). The vaccinee has been prescribed prednisone and referred to a rheumatologist. The vaccinees arthritis is ongoing of the times of report.										11/17/2005	11/25/2005	8		UNK	UNK	Concomitant drugs not reported.				CVOX200600053	1						1	Headache; Oedema peripheral; Pain; Rheumatoid arthritis	FLU3~EVANS VACCINES~61501~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0253176	03/23/2006	WI	50.0	49		M	03/23/2006	Patient has had a very sore left arm.  He has sharp shooting pains if he lifts his left arm up, especially over his head, and then this leads to persistent achiness.  No redness or swelling has occurred.  Symptoms have persisted now for 3 weeks.									U	03/02/2006	03/02/2006	0		UNK	UNK	lovastatin	none	hyperlipidemia			1						1	Hypokinesia; Pain	FLU3~SANOFI PASTEUR~u1881aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~ahavb105aa~1~IM~RA~HEP A (HAVRIX)~1|TDAP~SANOFI PASTEUR~c2340aa~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0253193	03/23/2006	GA	39.0			M	03/21/2006	This case was reported by a pharmacist and described the occurrence of unable to lift arm in a 39 year old male subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. Medical history included multiple sclerosis. Concurrent medications included interferon beta-la (Avonex) and Cyanocobalamin (Vitamin B12) which were indicated for the multiple sclerosis. On an unspecified date in 2005, before 01 December 2005, the subject received 1st dose of Fluarix in an unspecified arm (lot AFLUA139AA). The pharmacist reported that this was the, patient's 1st time receiving a flu vaccination. The pharmacist also reported that, the day after the vaccination, the patient was unable to lift his arm (that received the vaccination) more than 3 inches. There was no paralysis; the inability to move the arm was due to the ache. The subject was seen at a physician's office. At the time of initial reporting, 01 December 2005, the events were ongoing. The pharmacist considered the events to probably be related to vaccination with Fluarix.				Y					N				UNK	OTH	OTH	Interferon beta-la;Cyanocobalamin	UNK	Multiple Sclerosis The subject's concurrent conditions were not reported.		A0584309A	1						1	Hypokinesia; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA139AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0253194	03/23/2006	NJ	59.0			F	03/21/2006	This case was reported by a physician and described the occurrence of Bell's palsy in a 59 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The subject had no pre-existing medical conditions and is a non-smoker. There were no concurrent medications. The subject had received influenza virus vaccine (unknown manufacturer) in previous years with no adverse events following receipt of the vaccination. On 03 November 2005 at 3:00 pm, the subject received a dose of Fluarix in the left arm (lot AFLUA138BA). At 3:20 am on 04 November 2005, 12 hours after vaccination with Fluarix, the subject experienced Bell's palsy. The subject was seen at a physician's office and was treated with steroid (Steroids). The event resolved within 3 days. on an unspecified date in November 2005. The physician considered the event to be clinically significant (or requiring intervention) (OMIC). The physician reported that he will advise against future influenza vaccinations. The physician considered the Bell's palsy to possibly be related to vaccination with Fluarix.				Y					Y	11/03/2005	11/04/2005	1		OTH	PVT	No concurrent medication				A0585772A	1						1	Facial palsy	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA138BA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0253195	03/23/2006	NC	39.0	39		M	03/21/2006	This case was reported by a consumer and described the occurrence of muscle soreness at injection site in a 39 year old male subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The reporter is the subject. A physician or other health care professional has not verified this report. The subject's medical history included gastric reflux. Concurrent medications included Esomeprazole (Nexium) which was indicated for the gastric reflux. The subject had received an unspecified number of influenza virus vaccine immunizations in previous years with no adverse events. On 14 November 2005 at 15:00 pm, the subject received a dose of Fluarix in his left arm (dose number and lot number not provided). On 14 November 2005, less than one day after vaccination with Fluarix, the subject experienced deep muscle soreness at injection site. The subject went back to the health clinic as a result of the event, and the nurse was not able to help him. The event was ongoing at the time of initial reporting, 15 December 2005.				Y					N	11/14/2005	11/14/2005	0	UNK	OTH	PVT	Esomeprazole	UNK	Gastric Reflux The subject's concurrent conditions were not reported.		A0585930A	1						1	Injection site pain; Myalgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0253196	03/23/2006					U	03/21/2006	This case was reported by a healthcare professional and describe the occurrence of asthma related reaction in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The reporter is the co-worker of the subject. On an unspecified date, the subject received a dose of Fluarix (number of previous doses and lot number not provided). On an unspecified date, post vaccination with Fluarix, the subject experienced an asthma related reaction. The subject was seen at a physician's office. The subject had to improved between 14 and 21 days after the (Fluarix) shot. Asthmatic reaction was assessed as medically serious by manufacturer (OMIC).				Y					N					OTH	OTH					A0586491A	1						1	Asthma	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0253197	03/23/2006					U	03/21/2006	This case was reported by a healthcare professional and described the occurrence of asthma related reaction in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The reporter is the co-worker of the subject. On an unspecified date, the subject received a dose of Fluarix (number of previous doses and lot number not provided). On an unspecified date, post vaccination with Fluarix, the subject experienced an asthma related reaction. The subject was seen at a physician's office. The subject had to do breathing treatments within 5 days of vaccination with Fluarix. The event improved between 14 and 21 days after the (Fluarix) shot. Asthmatic reaction was assessed as medically serious by manufacturer (OMIC).				Y					N					OTH	OTH					A0586493A	1						1	Asthma	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0253198	03/23/2006	OH	40.0	40		M	03/21/2006	This case was reported by a consumer and described the occurrence of ringing in ears in a 40 year old male subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The reporter is this subject. A physician or other health care professional has not verified this report. The subject reported that he had previously received immunization with influenza virus vaccine (unknown manufacturer) with no subsequent adverse events. On an unspecified date in November 2005 at 10:00 am, the subject received a dose of Fluarix in the left arm (dose number and lot number not provided). Two days later, on an unspecified date in November 2005, the subject experienced ringing in ears, a rash on the upper part of the body and red faced. Three weeks after receiving Fluarix the subject was seen by dermatologist. The subject was prescribed antihistamines. The rash and facial redness resolved on an unspecified date on or before 19 January 2006, the ringing in the ear was ongoing.				Y					N	11/01/2005	11/01/2005	0	UNK	OTH	OTH	NONE	UNK	The subject had no pre-existing medical conditions. The subject's concurrent conditions were not reported.		A0589942A	1						1	Erythema; Rash; Tinnitus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0253199	03/23/2006	WA	55.0	54		F	03/21/2006	This case was reported by a nurse and described the occurrence of pain in a 54 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. There were no concurrent medications. The subject had received an unspecified number of immunizations of influenza virus vaccine (manufacturer unknown) in previous years with no adverse events following receipt of the immunization. On 05 January 2006 the subject received a dose of Fluarix in the right arm (lot AFLUA154AA). Approximately 12 hours later, on 05 January 2006, the subject experienced pain in the arm and the neck. The subject was seen at a physician's office. At the time of initial reporting, the event was ongoing. The nurse considered the event to probably be related to vaccination with Fluarix.				Y					N	01/05/2006	01/05/2006	0	UNK	PUB	PUB	NONE	UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported.		A0590549A	1						1	Neck pain; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA154AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0253200	03/23/2006	CT	42.0	41		F	03/21/2006	This case was reported by a physician and described the occurrence of arm numbness in a 41 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The subject had no adverse events following receipt of prior immunizations with influenza virus vaccine (unknown manufacturer). There were no concurrent medications. On an unspecified date in October 2005, the subject received a dose of Fluarix in the left arm (lot AFLUA138BA). Less than one month following the administration of Fluarix, on an unspecified date in October 2005, the subject experience numbness at the injection site and numbness of the left arm below the injection site. The subject was seen at a physician's office. At the time of follow-up reporting, 14 February 2006, the events were ongoing. The physician considered the events to probably be related to vaccination with Fluarix.				Y					N	10/01/2005	10/01/2005	0	UNK	OTH	OTH	NONE	UNK	The subject's medical history and concurrent conditions were not reported.		A0591130A	1						1	Hypoaesthesia; Injection site reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA138BA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0251244	03/24/2006	MD	38.0	38		F	03/18/2006	11/3/05 Received Fluzone and Pneumovax 23 vaccine; both in left arm. That night, excruciating pain in left arm, back and chest. Could not lift left arm. Took Tylenol and used a vibrator for the next 3 weeks trying to ease pain. Felt nauseated and cold 11/6 - 11/9. 12/13/05 Had first episode of shortness of breath while lying down. Lasted around 20 minutes. Inhaled breath felt cold. 12/13 Threw up 4 times, no ketones. Chest felt heavy and body achy. 12/16 Another shortness of breath episode while sitting up. Lasted 45 minutes. Made a doctor's appointment for 12/21. High white blood count -WBC- and 100.5 fever. Doctor said it was probably a bacterial infection and asthma. Prescribed Avelox and Advair. Had a chest x-ray. 12/26 Pain and pressure on left  side of chest. Went to doctor; said to see pulmonologist. 12/30 Rushed to hospital with severe chest pain and shortness of breath. Tests ruled out asthma. High WBC, fever, elevated cardiac enzymes, ketones. Home 1/1/06. Breathing not as labored. 1/5 Went to doctor. Said it must be viral; stop the Avelox. 1/8 Rushed to hospital with chest pains and shortness of breath again. Elevated cardiac enzymes. Sent for nuclear stress test. Heart fine. 1/21 Threw up 7 times, fever 100.5; still episodes of shortness of breath. Had echocardiogram. Heart is fine. Went to pulmonologist 2/6; had PFT test. Lungs are fine. Received abnormal mammogram and PAP smear results. Still having high WBC, fevers of 99.9 - 101.8 daily, shortness of breath, and sporadic pain in left back chest or arm. Now seeing infectious disease doctor. Going for nuclear tagged WBC scan 3/20 and 3/21. (OMIC)			Y	Y	Y				U	11/03/2005	11/03/2005	0	12/21/05: Doctor ran WBW, temperature; went for chest x-ray. 12/28/05: WBC and temp. 12/30/05: Did blood work, sinus CT scan, blood gases, chest x-rays, multiplanar reconstruction CT, MRI, CAT Scan of face and jaw. 1/8/06: Did blood work and ECG. 1/9: Nuclear stress test. 1/27: Echocardiogram. 2/1: Endocrinologist ran blood tests. 2/23-27: Doctor ran CBC with differential/Platelet tests. 2/28: RA Latex Turbid. 2/6: Pulmonary Function test. 2/7: Breast ultrasound guided core biopsy. 3/14: Blood cultures. 3/20-21: Nuclear tagged WBC scan.	UNK	UNK	Lantus and Humalog Insulin; Cozaar 100mg to protect the kidney.		White female, hearing impaired since birth, Type 1 Diabetic for 33 years, one pack a day smoker but has since cut back. Allergic to morphine, valium and codeine. Takes Lantus, Humalog and Cozaar - to protect the kidney.			1						2	Abdominal pain; Blood culture negative; Blood glucose increased; Cardiac enzymes increased; Chest pain; Chest pain; Computerised tomogram; Computerised tomogram abdomen normal; Computerised tomogram normal; Diabetic ketoacidosis; Discomfort; Dyspnoea; Dyspnoea; Echocardiogram; Electrocardiogram; Eye swelling; Fibrin D dimer normal; Hyperglycaemia; Leukocytosis; Malaise; Metabolic acidosis; Neutrophil count increased; Protein urine present; Pyrexia; Shoulder pain; Troponin I increased; White blood cell count increased; Asthma; Bacterial infection; Chest pain; Dyspnoea; Enzyme abnormality; Hypokinesia; Nausea; Pain; Pyrexia; Vomiting; White blood cell count increased	FLU3~SANOFI PASTEUR~U1863AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0529D~UNK~~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U1863AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0529D~UNK~~~PNEUMO (PNEUMOVAX)~2	USA	Life Threatening,Hospitalisation	Influenza
0252727	03/24/2006	MI	22.0			F	03/21/2006	Information has been received from a mother concerning her 22 year old daughter with arthritis, autism and allergy to cephalexin (Keflex) and floxins, who on 2/13/2006 was vaccinated with Pneumococcal 23v polysaccharide vaccine (lot 651573/0740R), in the upper right arm. Concomitant therapy included influenza virus vaccine (unspecified), in the other arm. On 2/13/2006 the patient experienced cellulitis in her upper right arm and abscess and was hospitalized for 11 days, The patients cellulitis in her upper right arm and abscess persisted. The mother noted that they believed that her daughters autism may be a result of DTP vaccine given as a child. Additional information has been requested.				Y	Y	11			N	02/13/2006	02/13/2006	0		OTH	OTH			Arthritis;Autism;Drug Hypersensitivity		WAES0603USA01588	1						2	Cellulitis; Injection site pain; Lymphadenopathy; Synovitis; Thrombosis; Cellulitis; Injection site abscess; Injection site reaction	FLU3~SANOFI PASTEUR~U1858EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0740R~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0740R~UNK~~UN~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0253240	03/24/2006	HI	24.0	24		F	03/20/2006	Developed amenorrhea for1 year after receiving AVA #2. Also developed motion sickness that persists to the present. 1 year later developed fibromyalgia/chronic fatigue syndrome. Symptoms: fatigue, malaise > 60 days, amenorrhea, nausea - motion sickness, diarrhea, constipation, dizziness, cognitive deficiency, dyspnea (shortness of breath), numbness left side of body.									N	10/21/2004	11/05/2004	15		MIL	MIL						1						1	Amenorrhoea; Cognitive disorder; Constipation; Diarrhoea; Dizziness; Dyspnoea; Fatigue; Fibromyalgia; Hypoaesthesia; Malaise; Nausea	ANTH~EMERGENT BIOSOLUTIONS~FAV088~2~~~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1457AA~3~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0253288	03/27/2006	CO	52.0	51		F	03/20/2006	Left upper arm became very sore, painful and stiff over a few weeks. 1/9/06 - MD diagnosed frozen shoulder and injected with cortizone. Arm was better for about 2 weeks and progressively returned to pain and stiffness. Arm being treated by a chiropractor since 1/30/2006; arm is still stiff and painful in deltoid muscle. Difficult to lift arm, put on seatbelt. Arm still stiff, sore and painful.				Y					U	11/29/2005	12/01/2005	2		PVT	PVT			Quinalone drugs, sulfa			1						1	Musculoskeletal stiffness; Myalgia	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0253289	03/27/2006	CO	4.0	4		F	03/24/2006	Right upper thigh erythema 8 X 10 cm induration 3.5 X 5 cm erythema centrally covering. Warm to touch. Started 3/22/06. Vaccines given 3/21/06 Tx'd with benadryl 1.5-2 tsp tid. Keflex 250/s 1 tsp tid #150 cc.				Y					Y	03/21/2006	03/22/2006	1		PVT	PVT						1						1	Erythema induratum; Feeling hot	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14A007AA~5~~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1866AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y08424~4~~RL~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0971R~2~~LL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA	Emergency room visit	Influenza
0253290	03/27/2006	IL	1.31	1	.3	M	03/20/2006	Pt received immunizations on 3/14/06. Parents noted right groin swelling 3/19/06. Denies fever, rash. Groin area swelling same color/temp as surrounding areas with size less than a dime per father. Father took child to MD. States MD said it was lymph node reaction. To keep eye on it. Return if not resolved by 2nd week of April.				Y					N	03/14/2006	03/20/2006	6		PUB	PUB						1						1	Lymphadenopathy; Swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B006AA~4~UN~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1743NA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0636P~1~UN~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA	Emergency room visit	Influenza
0253370	03/28/2006	IA	67.0	67		F		Patient described swelling of her arm from her elbow to her shoulder starting around 4:00 pm. Injection given around 2:30 pm. Arm swelled to nearly twice its size and was very painful. She saw her Dr the next am and the swelling had decreased. No residual problems. Her previous pneumovax was given in 1999.				Y					Y	10/13/2005	10/13/2005	0	WBC done - pt reports normal	PUB	PUB			Diabetes - diet controlled			1						1	Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~U1838AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~~2~IM~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0253380	03/28/2006	PR	33.0	33		M	03/22/2006	Depression, rash, and skin itch, lower back and back pain and others. Per 60 day follow up patient has not recovered has depression. All my records are at the VA.								Y	N	11/02/2003				MIL	MIL			lower back pain			1						1	Back pain; Depression; Pruritus; Rash	ANTH~EMERGENT BIOSOLUTIONS~~3~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~2~~~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Disabling	Influenza
0253405	03/28/2006	VA	1.03	1	.0	F	03/15/2006	Received vaccines 2/23/06, RTO on 3/13/06 presented with raised rash around injection site on left thigh, 4 papules, 2cms.				Y					Y	02/23/2006	03/13/2006	18		PUB	PUB						1						1	Injection site rash; Injection site swelling; Rash papular	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B006AA~2~~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1788EA~UNK~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0145P~2~~LL~HIB + HEP B (COMVAX)~1|IPV~SANOFI PASTEUR~Y0326~2~~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0234R~UNK~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A25969C~2~~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1022R~UNK~~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0253415	03/28/2006	MD	59.0	59		M	03/28/2006	The patient's left arm was noted reddened, swollen and warm to the touch.  The patient stated that the swelling began after he recieved influenza and pnuemonia vaccines.									Y	03/22/2006				UNK	UNK	atorvastatin 40mg po qday Bumetanide 2mg po qday Cephalexin 250mg po qid Digoxin 0.25mg po qday Esomeprazole dr 40mg qday Aspart Insulin , sliding scale insulin NPH 40 units am, 46 units pm metoprolol xl 12.5mg po qday Metronidazole 500mg t	GIB sts	nkda, hypertension, hyperchloesterolemia			1						1	Erythema; Feeling hot; Swelling	FLU3~SANOFI PASTEUR~V1914AA~1~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~1117R~1~ID~LA~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0253426	03/29/2006	TX	80.0	80		F	10/12/2005	Pt reported that at  pneumococcal site she had pain, swelling, heat, redness which extended down to wrist. Contact ER - nurse advise to take Tylenol. She went to Dr on her traveling. On Monday at 6 pm given 10 days of cephalexin 500 mg to take qid. Direct back or used at 08:30 that decreased swelling. No redness, states she can now bend her elbow and it seem to be getting better. Client asked to call back when she returns from her visit out of town and give additional information of when symptoms subsided completely. She also stated that she did not have any difficultly breathing, no hives and no itching. The Flu shot site was without any reaction she said.				Y						10/09/2005	10/09/2005	0		OTH	UNK						1						1	Injection site hypersensitivity; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U1744AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0772P~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0253427	03/29/2006	TX	31.0			F	10/15/2005	L deltoid - pneumococcal vaccine, experienced severe pain scale 1-10 #10. Spoke to Dr 9/27/05. Dr thought it could be reaction from flu shot. There after she reported she were  paralyzed from neck to toes could not move. Experienced difficulty breathing, symptoms. Subsided on the third day at 08:30 am.									Y	09/26/2005	09/27/2005	1		OTH	UNK		Cerebral Palsy/Heart Condition				1						1	Dyspnoea; Pain; Paralysis	FLU3~SANOFI PASTEUR~U1744AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0253428	03/29/2006	TX	55.0	55		F	10/05/2005	On 10/4/05 L upper arm toward back with redness and swelling approx 1 in diameter. Experienced pain along the whole arm.									Y	10/03/2005	10/04/2005	1		UNK	UNK						1						1	Erythema; Pain; Swelling	FLU3~SANOFI PASTEUR~U1744AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0253429	03/29/2006	TX	74.0	74		F	09/30/2005	9/27/02: 74 y/o female reported, aches in legs and head and sneezing, felt lousy, low grade fever 98 degrees am increase to 99.9 pm. 9/28/05 clear mucous from nose, sneezing caused. 9/29/05 T=100 deep bronchial cough with dark green phlegm/ 9/30/05 feel much better today. No redness, no soreness at site of injection.									Y	09/26/2005	09/27/2005	1		OTH	UNK						1						1	Bronchitis; Cough; Headache; Malaise; Pain; Pyrexia; Rhinitis; Sneezing	FLU3~SANOFI PASTEUR~U1744AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0253430	03/29/2006	TX				F	03/18/2006	10/5/05 In arm right deltoid pneumoccal vaccine site, soreness, warm. Swelling, aching /// /// /// swelling down arm to armpit. Says she took ibuprofen /// also took benadryl last night. Edema progressed /// 4 fingers above her elbow in her right arm /// /// //// //// .									U	10/04/2005	10/05/2005	1		UNK	UNK						1						1	Feeling hot; Injection site pain; Injection site swelling; Oedema	FLU3~SANOFI PASTEUR~U1744AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0253437	03/29/2006	PA	32.0	32		F	03/29/2006	Rcvd Hepatitis B and Influenza vaccines same day (11/16/2005).  Diagnosed with Guillain Barre syndrome on 2/7/2006 after experiencing tingling sensations in hands/feet and increasing weakness and paralysis which started 2/3/2006. Discharge summary states dysphagia. msv			Y	Y	Y	10			Y	11/16/2005	02/03/2006	79	Spinal tap revealed elevated protein, blood workup to exclude infection and other diseases were done, chest xrays, MRI (negative), also EMG. Discharge summary states antibodies elevated. msv	UNK	UNK	NONE	NONEDischarge summary states sinsitis. msv	NONE			1						1	Autoantibody positive; CSF test abnormal; Dysphagia; Guillain-Barre syndrome; Muscular weakness; Paraesthesia; Paralysis	FLU3~SANOFI PASTEUR~U1763AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB172AA~2~IM~RA~HEP B (ENGERIX-B)~1	USA	Life Threatening,Hospitalisation	Influenza
0253440	03/29/2006	VA	1.0	1	.0	F	03/29/2006	Diagnosed with chicken pox 3/16/2006.  Fever per parent report.  Scattered, small, mildly pruritic vesicles on back, face and legs.				Y					Y	10/20/2003	03/13/2006	875	None	UNK	UNK	Benadryl	None	None			1						1	Blister; Pyrexia; Rash; Viral infection	FLU3~SANOFI PASTEUR~U1147AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0627N~3~IM~UN~HEP B (RECOMBIVAX HB)~1|VARCEL~MERCK & CO. INC.~1058M~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0253470	03/30/2006	TN	57.0			M	11/16/2005	Hx of taking the flu injection three days ago and two days ago a red rash and itching began. States it worst on face, back, chest and arm. Never had a problem before taking the flu shot in the past. Hx of SOB with COPD, no, no chest pain. Pt give vistaril and discharged from ER. Pt actually came back to the ER on 11/23/05 to say that the rash had not gotten any better. More vistaril given and pt discharged.					Y					11/14/2005	11/16/2005	2		UNK	UNK			Hx of SOB with COPD			1						1	Lung disorder; Rash erythematous; Rash pruritic	FLU3~SANOFI PASTEUR~U1929AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0253471	03/30/2006	TN	70.0			M	10/25/2005	Pt received flu shot on 10/25/05 and developed rash/itching on arms and trunk which required ER visit and derm visit. Pt discharged from ER and given Decadron plus Claritin 10mg qd.					Y					10/25/2005	10/25/2005	0		UNK	UNK						1						1	Rash pruritic	FLU3~SANOFI PASTEUR~U1614AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0253472	03/30/2006	TN	1.23	1	.2	M	03/24/2006	Pt. grandmother states child is wheezing would someone check child? Clinic staff report child had been running around waiting room following shots. Mother reports recent Dx of asthma. Pts respirations 30 min and heart rate 140/min. Faint expiratory wheezing hear and over bronchial tubes. Slight prickly rash noted around collar area. Pt in no apparent distress. No retractions or respiratory distress noted. Called 911. EMTs arrived. No respiratory distress noted. Pulse by OZ sat monitor/pulse ox 150/min. O2 sat was 99% per pulse ox. Pt mother declined need for ride by ambulance to ER. Mother referred to ER for elevated heart rate. Rash on collar area faded prior to leaving clinic. Mother states she will take child to children's ER for follow up.				Y					Y	03/15/2006	03/15/2006	0		PUB	PUB	albuterol PRN	Hx of asthma - recent diagnosis Medical records state bilateral otitis media, conjunctivitis. msv	Hx of asthma - recent diagnosis			1						1	Asthma; Heart rate increased; Rash; Wheezing	FLU3~SANOFI PASTEUR~U1787AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0253498	03/30/2006	FL	84.0	83		M	03/30/2006	Approx 6 weeks after patient received flu vaccine patient c/o soreness left upper arm. Came to Health dept. No tenderness, bruising or knot noted. Client then went to his pvt MD. X-rays were taken of left arm, came out neg. Returned to Health dept. still c/o left arm pain.				Y					N	01/04/2006	01/25/2006	21	x-ray left arm	UNK	UNK	unknown	no	no			1						1	Pain	FLU3~SANOFI PASTEUR~U1904AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0253508	03/31/2006	IN	77.0			M	03/30/2006	Patient cannot move arm around especially in the morning.  This started right after reaction on the injection site.  Patient uses left arm where he got the pneumovax, to play golf.  It has affected his golfing.									Y	10/14/2005	10/17/2005	3		OTH	OTH		pain, redness, site of injection.	N/A			1						1	Hypokinesia; Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0579P~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0253514	03/31/2006	FL	1.03	1	.0	F	03/27/2006	Patient still got chickenpox after receiving varicella vaccine.				Y					U	01/03/2006	03/24/2006	80		PVT	PVT						1						1	Drug ineffective; Infection	FLU3~SANOFI PASTEUR~U1867DA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0483R~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0549R~UNK~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0253549	04/03/2006	WA	82.0	81		M	03/30/2006	24 hrs after getting flu/pneumo shot. Chest had cough and cold s/s, paralysis of left side, loss of balance and stiff neck lasting 1 1/2 wks. Prostate and urinary probs.Medical records disprove paralysis, abnormal gait. Does confirm fatigue. msv				Y					Y	12/01/2005	12/02/2005	1	Metabolic panel, CAT scan pelvis/abdo with contrast, UA culture. Medical records confirms abnormal lab test. msv	PVT	PVT	BP meds	Prostate, urinary retention	Neck injury in 1942.			1						1	Cough; Fatigue; Laboratory test abnormal; Musculoskeletal stiffness; Pharyngitis; Rhinitis	FLU3~SANOFI PASTEUR~U1868AA~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0748P~3~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0253572	04/03/2006	OR	43.0	43		F	03/29/2006	Acute hepatitis. Transit and now resolved. Chest pain admission 11/17/05 likely related, non cardiac cause as final diagnosis. Medical records include pharyngitis, bacterial infection . msv					Y	1			Y	11/15/2005	11/17/2005	2	Lipase, Hep A, B, C negative, ANA, smooth muscle antibody, thyroid function, hematochromocytosis screen negative, LFT's peaked 12/1/05.  Medical records include urine bilirubin increased, increased alt, ast. msv	PVT	OTH	Trazodone, Fish oil, calcium, multivitamin.		Ovarian cyst (resolved 2000), spontaneous pneumothorax 1978 Medical records state hepatic syndrome. msv			1						1	Alanine aminotransferase increased; Aspartate aminotransferase increased; Bacterial infection; Blood bilirubin increased; Chest pain; Hepatitis; Liver function test abnormal; Pharyngitis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA132AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0253621	04/03/2006	ME	33.0			M	04/03/2006	Patient complained of pain in left upper arm.  Left arm elbow to shoulder reddened, with slight swelling, warm to touch.									Y	03/31/2006	04/02/2006	2	N/A	PUB	PVT		Hypertension, GERD	Hypertension, GERD, NKA			1						1	Erythema; Feeling hot; Pain; Swelling	FLU3~SANOFI PASTEUR~U1911AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~C741R~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0253617	04/04/2006	CA	5.0	5		M	04/03/2006	Swelling. There were swellings 2cm x 3 cm noted on 4/2/06 by mom.									U	03/31/2006	04/03/2006	3	N/A	PVT	PVT						1						1	Swelling	FLU3~SANOFI PASTEUR~U1914AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0706R~UNK~~LA~HEP A (VAQTA)~1	USA		Influenza
0253626	04/04/2006	MD	47.0	47		F	11/17/2005	47 year old active duty physician presents with acute severe neuralgia pain over right lower face with onset approximately 8 hours after receiving live influenza vaccine intranasally.										11/14/2005	11/17/2005	3	CT of sinuses normal; pantopex dental x-rays normal	UNK	UNK	Ibuprofen, Oxycodone		History of autoantibodies and family history of autoimmunity.  Remote history of migraine but asymptomatic for 2 years.  Different pain.			1						1	Neuralgia	FLUN3~MEDIMMUNE VACCINES, INC.~500390P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0253639	04/04/2006	VA	47.0	47		M	10/11/2005	Approximately 36 hours post follow up mist vaccination.  Patient broke out with rash on legs, spreading to arms, itchy.  Mild flu-like symptoms noted and some throat tingling, tightness about 48 hours post vaccination.				Y					N	10/05/2005	10/06/2005	1		OTH	MIL		NO	NONE			1						1	Influenza like illness; Pruritus; Rash; Throat tightness	FLUN3~MEDIMMUNE VACCINES, INC.~500390P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0253665	04/04/2006	AZ	0.37	0	.4	M	03/29/2006	Persistent fever and irritability for 48 hrs after vaccines.									Y	08/09/2005	08/09/2005	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Irritability; Medication error; Pyrexia	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B002AA~2~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~Y02652~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE575AA~2~IM~LL~HIB (ACTHIB)~1|PPV~MERCK & CO. INC.~0512P~1~IM~LL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0253709	04/05/2006	PA	1.0	1	.0	F	04/05/2006	Child received varicella vaccine 11/08/2002.  Diagnosed with disease 04/04/2006.										11/08/2002	04/04/2006	1243	N/A	PVT	UNK		NONE	NONE			1						1	Drug ineffective; Infection	FLU3~SANOFI PASTEUR~U0988BA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0599M~UNK~~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0253710	04/05/2006	GA	19.0	18		F	12/01/2005	10 minutes after administering flu shot, patient complained of swelling in eyelids, lips and throat getting tight.  Administered Benadryl and epinephrine.  Stabilized.  911 called and responded, patient taken to ED.				Y					Y	11/08/2005	11/08/2005	0		PUB	PUB		denies			GA05047	1						1	Eye swelling; Swelling face; Throat tightness	FLU3~SANOFI PASTEUR~U1904AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0253711	04/05/2006	GA	41.0	40		F	11/29/2005	Arm sore within minutes tingling in fingers of right hand within 3 days.  Continues today with numbness right hand.  Bruising at injection site.  No fever.				Y					U	10/24/2005	10/24/2005	0		OTH	PUB		NO	NO		GA05046	1						1	Contusion; Hypoaesthesia; Pain; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA151BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0253712	04/05/2006	GA	47.0	46		F	03/10/2006	Sore arm, seizure, 1 month after flu shot, 12/19/2005.  Went to hospital.				Y					Y	11/18/2005	11/19/2005	1	EEG, CT at hospital	PUB	PUB	Protonics, Claritin, Zestoretic, Cranberry supplement	NONE			GA06010	1						1	Convulsion; Pain	FLU3~SANOFI PASTEUR~U1930AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0253736	04/05/2006	CA	12.0	11		F	03/31/2006	LEFT DELTOID AREA RED AND HOT TO TOUCH HAS NO FEVER MOTHER STATES ON DAY CHILD WAS VACCINATED CHILD WAS VERY TIRED AND SLEEPY.  OTHER WISE CHILD FINE.									Y	03/29/2006	03/31/2006	2	NONE	UNK	UNK	NONE	NONE	NONE			1						1	Erythema; Fatigue; Feeling hot; Somnolence	FLU3~SANOFI PASTEUR~U1765HA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~SANOFI PASTEUR~U1812AA~1~IM~LA~MENINGOCOCCAL (MENOMUNE)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B002AA~6~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0253795	04/07/2006	IN	1.37	1	.4	M	04/07/2006	2/15/06 - child slept through the night,8:00 am woke up with Blotchy, Red, Swollen, hive like areas on body with systemic rash. No respiratory distress. Decreased eating habits throughout entire time frame of reaction. Temp. ranging from 99.9-100.6 for several days. No complaints of pain. Mom states he was fussy, but not itching. 10AM on 2/16/06 seen local physician. Had been receiving amoxicillin (10 day dosage) for week prior to vaccination for ear inf. Only given Tylenol for reaction symptoms. No other tx. given. Mom states it did take until Friday for rash to begin disappearing. At this point, rash felt very sandpapery. Redness/blotch/swelling was down, but redness would continue if he got too hot or if he cried. Complete recovery with appetite returned to normal.				Y					Y	02/14/2006	02/15/2006	1	No diagnostic testing done at physician visit.	UNK	UNK	Amoxicillin for ear infection. 10 day regime. On day 7 on arrival to clinic.	Recovering from an ear infection.	None			1						1	Erythema; Irritability; Pyrexia; Rash; Rash macular; Swelling; Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14A009BA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1788EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08633C~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0253808	04/07/2006	FL				M	04/04/2006	Information has been received from a male consumer regarding a case in litigation who in 11/1996, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included a dos of influenza virus vaccine (unspecified). Within 24 hours, the patient was in the ER with saucer size blotches on his torso, thighs, arms, and sides. Prednisone was prescribed (in descending amounts) along with clobetasol propionate (Temovate) and was ineffective. Two months later, it erupted again with the same results from treatment. The consumer stated he has been undergoing this cycle 4 to 5 times a year and dermatologist have been unable to stop the eruptions. The consumer noted that his quality of life has been damaged. At the time of this report, the patient has not recovered. Saucer sized blotches on his torso, thighs, arms, and sides was considered to be disabling. Additional information has been requested.				Y				Y	N	11/01/1996	11/01/1996	0		OTH	OTH					WAES0603USA03731	1						1	Rash; Rash macular	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0253862	04/10/2006	MD	53.0	52		F	10/21/2005	Discomfort in joints; neck, writs, hips, knees, ankles, top of feet, fingers.									Y	10/20/2005	10/21/2005	1	NONE	PUB	PUB	Prednisone, Imuran, Atenolol, Aygestine, Cyclosporin, Nexium, Cardizem, Lasix	NO	Kidney disease, status post kidney transplant			1						1	Arthralgia	FLU3~SANOFI PASTEUR~M1836AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0253863	04/10/2006	OH	53.0	52		F	04/05/2006	Complained of pain shortly after receiving injection.  Severe pain caused limited range of motion.  Presented with complaints nearly 4 months after injection.									U	11/16/2005	11/16/2005	0	NONE	OTH	PVT		NONE	None known			1						1	Joint range of motion decreased; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61322~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0253997	04/11/2006	CA	77.0	76		M		The day following flu shot developed a mild headache which has persisted to this date. Stated it is not debilitating just there.				Y					N	10/22/2005	10/23/2005	1	Had a CT scan 2 months post shot and an MRI 1 1/2 months following CT. CT showed no significant changes (but no prior studies to compare wit), MRI showed mild sinus blockage.	PUB	PUB	1/4 ASA, Singular	NONE	COPD			1						1	Headache; Sinus congestion	FLU3~SANOFI PASTEUR~U1770AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0254051	04/13/2006	MN				F	12/27/2005	The patient received FLUMIST on 12/20/2005 and 2 days later, on 12/22/2005, developed a rash on her trunk and arms.  The rash was treated with diphenhydramine as needed, but failed to resolve.  Prior to receiving FLUMIST she had eye surgery on 12/16/2005 and took VALIUM and saline eye drops following surgery.									U	12/20/2005	12/22/2005	2		PVT	PVT	VALIUM; saline eye drops		Eye surgery on 12/16/2005 and subsequent treatment with vVALIUM and saline eye drops.		MEDI0003950	1						1	Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500394P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0254052	04/13/2006	CA	48.0			F	12/28/2005	MEDI-0003953 is a Non-Serious spontaneous case from a nurse in the USA of a 48 year old woman involving flu-like symptoms. The reporter causality is possible to FluMist. A 48 year old female pt received FluMist vaccination, intranasally on 12/22/2005 for influenza immunization. The pt received Trivalent Inactivated Influenza Vaccine (TIV) for the last 3 years. No other concomitant medications were reported. The night of the vaccination the pt began to feel ill. The feeling worsened over the next day. The exact symptoms were unspecified however they were described as flu-like symptoms. No other information was provided.									U	12/22/2005	12/22/2005	0		PVT	PVT	NONE		NONE		MEDI00039530	1						1	Influenza like illness	FLUN3~MEDIMMUNE VACCINES, INC.~500426P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0254053	04/13/2006	CA	40.0			F	01/12/2006	A 40 year old female who received FluMist on 01/06/2006 with family reported a stuffy nose, achiness, cough and a fever.  No history of close contact with anyone with flu or a cold.  The physician did not treat symptoms and the symptoms are ongoing.										01/06/2006	01/06/2006	0		PVT	PVT	Concomitant drugs not reported.				MEDI0004047	1						1	Cough; Nasal congestion; Pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500395P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0254054	04/13/2006	CA	5.0			F	01/12/2006	A 5 year old female who received Flumist on 01/06/2006 reported stuffy nose, achiness, and cough.  No history of close contact with anyone with flu or a cold.  Physician did not treat symptoms and still having symptoms of cold.										01/06/2006	01/06/2006	0		PVT	PVT	Concomitant drugs not reported.				MEDI0004049	1						1	Cough; Nasal congestion; Pain	FLUN3~MEDIMMUNE VACCINES, INC.~500395P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0254055	04/13/2006	CA	8.0			F	01/12/2006	This is a Not Serious Spontaneous case from a Pharmacist in the USA of stuffy nose, achiness, and cough. The reporter causality is possible to FluMist. This case is submitted according to the VAERS Safety surveillance accelerated reporting agreement for FluMist. An 8 year old female who received on 1/06/06 with family reported stuffy nose, achiness and cough. No history of close contact with flu or a cold. The pt's physician did not creat symptoms. The symptoms are still ongoing.									N	01/06/2006	01/06/2006	0		PVT	PVT	Concomitant drugs not reported				MEDI00040500	1						1	Cough; Nasal congestion; Pain	FLUN3~MEDIMMUNE VACCINES, INC.~500395P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0254056	04/13/2006	NE	6.0			U	12/22/2005	A nurse reported that a 6 year old child received expired FLUMIST vaccine on 12/16/05. No adverse event was reported. The reporter causality is not provided to FLUMIST. No other information was provided.									U	12/16/2005	12/16/2005	0		OTH	OTH	Concomitant drugs not reported				MEDI00039410	1						1	Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0254057	04/13/2006	SC	39.0	39		F	12/30/2005	A female consumer reported that she experienced irritating cough and slight tightness in the chest the next day and everyday after she received FLUMIST vaccine on 12/15/2005. She later found out that she should not have received FLUMIST due to her past medical history of asthma, although she is not sure if these symptoms are due to FLUMIST or not. The event has been considered resolved.									Y	12/15/2005	12/16/2005	1		OTH	OTH	NASONEX; ADVAIR		Asthma		MEDI0003992	1						1	Chest discomfort; Cough; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0254058	04/13/2006	WI	39.0	39		M	01/10/2006	This is a non serious spontaneous case from a registered nurse in the USA of migraine and small nodule in nose (unlabelled, USA). The reporter causality is possible to FluMist. This case is submitted according to the VAERS Safety Surveillance Accelerated reporting agreement for FluMist. MEDI00040340 is a 40 year old male that was vaccinated with FluMist intranasally on 1/6/05. Within 1-1.5 hours of received the vaccine, he developed a migraine and a small nodule (1 millimeter) inside his right nostril. There was no aura or other migraine symptoms, and he did not take anything to treat his migraine. The nurse was not able to palpate the nodule. No treatment was prescribed for the nodule and the pt reported that the nodule had been decreasing in size. The clinical outcome of this event in unknown. Follow up - Patient's DOB and vaccine lot number provided.									U	01/06/2006	01/06/2006	0		PVT	PVT	Concomitant drug (s) not reported				MEDI0004034	1						1	Migraine; Skin nodule	FLUN3~MEDIMMUNE VACCINES, INC.~5003938~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0254059	04/13/2006	IL	35.0	34		M	03/16/2006	MEDI0004267 is a Not Serious Spontaneous case from a physical therapist in the USA involving joint stiffness. The reporter causality is not provided to FluMist. On 12/8/2005, she began to complain bilateral muscle pain and joint stiffness. The pain began behind the kneecaps when going from sitting to standing. He took naproxen which relieved the pain. However, the pain returned whenever naproxen was not taken. The pt saw his primary care physician sometime at the end of 12/05, and was given naproxen. After a day of starting Naproxen, on 1/6/06, he developed soreness of the muscle, bilateral muscle pain and joint stiffness. Oxiproxin was discontinued. This event is ongoing.									N	12/07/2005	12/08/2005	1	ANA, CBC (complete blood count) on 1/20/06-normal. Culture of left elbow-staphylococcus aureus positive on 10/23/05 and ESR-normal on 1/20/06.	PVT	PVT	Concomitant drugs not reported		10/23/05: Culture of elbow revealed staph aureus1o/20/05; CBC, ESR and ANA were normal.		EDI00042670	1						1	Bacterial infection; Joint stiffness; Myalgia	FLUN3~MEDIMMUNE VACCINES, INC.~500391P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0254079	04/13/2006	OK	19.0	18		F	04/13/2006	6 hours after receiving YF vaccine client c/o abdominal pain and was taken to the ER by father who is a physician.  Given Lortab for pain, but no relief and returned again to ER with same c/o.  Telephone call from mother with above information and she stated that they were going to check her liver enzymes at that time.				Y						04/07/2006	04/07/2006	0	liver enzymes	UNK	UNK	unknown	none	none			1						1	Abdominal pain	FLU3~SANOFI PASTEUR~1881AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|YF~SANOFI PASTEUR~UE813AA~1~SC~RA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0254082	04/13/2006	WA	1.48	1	.5	F	04/13/2006	10/19/05: Mom called PCP re swelling on L leg the size of a quarter at site of vaccines had increased to double that size.  Instructed to use ice and tylenol.  10/27/05: Mom called PCP child's tummy not feeling well. 11/7/05: 2PM PCP office visit. Both of child's thighs have large blisters with welts on L thigh.  PCP states contact dermatitis inner groin due to new diaper wipes.  Instructed to stop using new diaper wipes. 11/7/05: 7:30 PM Mom called stating rash spreading to eyes, face and going down neck, child fussy.  Instructed to go to ED. 11/7/05: ED physical exam states vital signs stable. afebrile. Does not appear ill. ENT: Oropharnynx: Clear. TMs and throat clear. Neck supple. Lungs: clear.Cardiac: regular rate and rhythm. Skin: diaper area-type rash, but well peripheral to this there are also some separate and distinct-appearing urticarial plaques out on the lateral thighs. Similar urticarial plaques can be noticed on the back of the neck. No vesicles, pustules or drainage or discharge.  No petechiae, prpura.  Assessment Urticaria.  Given Benadryl x 1 in ER Resume old wipes and eliminate the new wipes. Benadryl as recommended at home.  FU with doctor.				Y					Y	10/17/2005	11/07/2005	21	None	UNK	UNK	Flouride drops	None				1						1	Abdominal pain upper; Dermatitis contact; Injection site swelling; Injection site vesicles; Irritability; Rash; Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B006AA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1743LA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0644P~1~IM~LL~HEP B (RECOMBIVAX HB)~1|VARCEL~MERCK & CO. INC.~0556R~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0254144	04/17/2006		10.0			M	04/12/2006	Seriousness criteria Other medically significant (OMIC). From initial information received on 4/4/2006 from a literature report entitled PET scan hypermetabolism induced by influenza vaccination in a patient with non Hodgkin lymphoma. It was reported, that a 10 year old boy developed an intense hypermetabolism area on positron emission tomography PET scan after receiving influenza virus vaccine. The boy, who was two years off therapy for non Hodgkins lymphoma, received an influenza virus vaccine (dosage not stated) in his left deltoid muscle and, nine days later, a routine PET scan showed an intense hypermetabolism area in his left axillary region and a smaller hypermetabolism area in his left supraclavicular area, a disease progression was suspected. The boy underwent excision on his lymph node (1.3 in greatest dimension), a reactive lymph node with evidence of follicular and interfollicular hyperplasia was found. Eight months after the initial PET scan, another hypermetabolic lymph node was found in his left axilla with about half of the metabolic intensity of his initial node. The node (2.5 cm in greatest dimension) was excised and was found to have florid hyperplasia with no lymphoma evidence. Author comment, the intense isolated hypermetabolism areas on two occasions, the pathological findings of reactive lymph nodes and the boys continued good health nine months after the initial PET scan, support the hypothesis that this hypermetabolism area (occurred as a result of local antigens processing and lymphocyte proliferation in response to the patients influenza vaccination). A search did not reveal any7 previous case reports of hypermetabolism associated with influenza virus vaccine.				Y					U				Florid hyperplasia with no lymphoma evidence.	UNK	UNK			The patient had a history of non Hodgkins lymphoma.		200600779	1						1	Hyperplasia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0254146	04/17/2006	MS	1.4	1	.4	F	04/14/2006	Initial report received on 1/31/2006 from a health care professional. A 17 month old female patient with no significant medical history had received an administration (route not reported) of Fluzone SV 2005 2006 USP, lot number U1915AA, in the left thigh and an administration (route not reported) of Tripedia, lot number U1345BA, in the left thigh on 1/25/2006. At an unspecified time later, the patient developed an injection site abscess with redness and edema. The abscess was verified by ultrasound and the patient was evaluated by a physician and treated with antibiotics. At the time of this report, the patient had recovered from these events. The reporter for this case is the same as for case 200600227. Follow up information received on 4/10/2006. The patient has a past medical history of recurrent otitis media with myringotomy and tympanostomy tube placement in Oct 2005. The patient received her Fluzone and Tripedia vaccine intramuscular on 1/25/2006. One day post immunization, she developed severe left leg redness, swelling and pain at the injection site. She was seen by her physician the following day. On examination, her left proximal thigh had a large area of erythema, induration, tenderness and warmth around and distal to the injection site. She was also found to have an ear infection, earache, rhinitis, intermittent fever and cough. She was diagnosed with acute upper respiratory infection and ear infection. Per the physician, there was a small risk for cellulitis/abscess, and she was admitted to the hospital for treatment. She was to have a CBC with platelets, influenza swab, and RSV test. No laboratory results were provided.				Y	Y	0			Y	01/25/2006	01/26/2006	1		PVT	PVT					200600226	1						1	Cellulitis; Condition aggravated; Cough; Ear pain; Injection site abscess; Injection site erythema; Injection site hypersensitivity; Injection site induration; Injection site oedema; Injection site pain; Injection site warmth; Otitis media; Pyrexia; Rhinitis; Tenderness; Upper respiratory tract infection	DTAP~SANOFI PASTEUR~U1345B~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1915A~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0254155	04/17/2006	NY	0.52	0	.5	F	04/11/2006	Friday 04/07/2006, Mom states felt warm and gave Advil.  Saturday, 04/08/2006, no fever but left leg child was keeping straight, no noted redness or swelling.  Was seen at doctor on Monday, 04/10/2006, but Mother upset and was unable to examine baby well.				Y					U	04/06/2006	04/07/2006	1	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Feeling hot	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B053EA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1787DA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE709AA~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B08634H~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0254218	04/18/2006	IA	0.75	0	.8	M	03/20/2006	on 3/3/06 pt developed rash on chest, face, neck and back, arms. Eyes started swelling by evening so took to ER. Physician in ER dx'd as allergic to eggs, ordered Benadryl and Amoxil. 3/4 mom brought pt to our clinic for follow up. Rash remained. PA ordered Prednisone (Burst and taper) on 3/11/06.				Y					Y	02/25/2006	03/03/2006	6	NONE	PVT	PUB	NONE	NONE				1						1	Eye oedema; Hypersensitivity; Rash	FLU3~SANOFI PASTEUR~U1787EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0254219	04/18/2006	TX	1.02	1	.0	F	04/10/2006	Had Varivax at health dept 3/14/06. Was seen in my office by me 4/6/06 complaining of several days of insect bites, on exam pt had lesions consistent with Varicella < or = to 10 lesions.									Y	03/14/2006	04/03/2006	20		PUB	PUB	NONE	NONE	NONE			1						1	Skin ulcer; Viral infection	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0254284	04/18/2006	AK	1.6	1	.6	F	04/07/2006	Pt had influenza @ time of receiving vaccine. She had been given Tylenol prior to the vaccine appointment, per her foster parents. She was febrile in the evening and also today 4/7/06.				Y					N	04/06/2006	04/06/2006	0	Rapid Influenza-Positive 4/7/06	PUB	OTH		Influenza			AK200628	1						1	Pyrexia; Viral infection	FLUX~UNKNOWN MANUFACTURER~~1~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0254305	04/19/2006	TX	37.0	37		M	04/19/2006	Flushing, pruritis, heartburn, facial erythema, diaphoresis, chills.				Y					Y	04/18/2006	04/18/2006	0	None, but treated with Zyrtec, Zantac, and injectible epinephrine	MIL	MIL		none	Prior rxn to flu shot, 10 years prior, pt did not reveal this, thought to be due to thiomerasol, pt not egg allergic.			1						1	Chills; Dyspepsia; Erythema; Flushing; Hyperhidrosis; Pruritus	FLU3~SANOFI PASTEUR~U1916AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0254318	04/19/2006	MA	59.0	58		F	11/22/2005	2 hours after injection developed chest pressure cough. Chills and nausea, resolved on their own within several hours.									Y	11/20/2005	11/20/2005	0	NONE	PUB	UNK	Claritin		dawn, grass, pine, latex sensitivity			1						1	Chest discomfort; Chills; Cough; Nausea	FLU3~SANOFI PASTEUR~1802BA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0254319	04/19/2006	MA	47.0	47		F	11/24/2005	Approx 1 hour after receiving the shot, felt tightness in throat, dry mouth, thirsty, funny feeling in lower lip, vital signs stable, no respiratory distress, heart rate normal. Given 50 mm Benadryl, Returned to work after 1 hr observation.									Y	11/02/2005	11/02/2005	0	NONE	PUB	UNK		No	Asthma, allergic to Ibuprofen - hives.			1						1	Dry mouth; Thirst; Throat tightness	FLU3~SANOFI PASTEUR~41802BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0254342	04/20/2006	AK	22.0	22		M	03/14/2006	Reports He ETOH abuse and low immune system. On 3/10 he requested following TD, Flu, Pneumonia vaccine, even though he is only 22 YR old. On Sat 3/11, client reports awakening with red, swollen, tender left arm with limited ROM. Around 2pm, noted fever 102.4, and feeling achy all over. Saw DR who prescribed Z Pac 5day and Ibuprofen. 3/14 Still C/O some tenderness, and swelling able to move arm better, but still not full ROM.				Y					Y	03/10/2006	03/11/2006	1		PUB	PUB	Steterra, IBP, Tylenol PRN	Non specific SX: cough, weakness				1						1	Injection site hypersensitivity; Injection site oedema; Joint range of motion decreased; Pain; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~U1754AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1040P~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2340AA~1~IM~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0254384	04/20/2006	FL	52.0	52		F	01/31/2006	Started with severe posterior thigh pain and cramping. Pair became progressively worse and she was unable to walk. Hospital ER, Admission, Rehab. Treatment with high dose steroids. Diagnosed with Transverse Myelitis at the L2 level. Remains wheel chair bound at this time. 5/5/06 Medical records received from 1st hospital which reveal patient received flu vaccine approx 1 mo prior to experiencing sudden onset severe posterior thigh pain w/cramping on 12/11/05 which became progressively worse & she presented to the ER.  MRI of the LS spine showed edema of terminal spinal cord & clonus.  Patient was then transferred to larger hospital for evaluation which revealed diagnosis of acute transverse myelitis at L2 level.  She was treated with high dose steroids w/ on ly approx 30-40% improvement in symptoms & was transferred back to initial treating facility.  Has continued pareparesis & weakness of the quadriceps femoris & illiopsoas muscles in the distribution of the posterior tibial & common peroneal nerves consistent w/L2 transverse myelitis, worse on the right, along w/bowel & bladder incontinence.  PMH: MVP & HTN.  5/11/06 Received medical records from PCP which reveal patient had shingles 4/05.  As of 3/06, patient only able to take a few steps w/a walker.  5/30/06 Received medical records from larger hospital which did not reveal any new dx/ss				Y	Y		Y		N	11/18/2005	12/11/2005	23		PVT	PVT			Mitral Valve Prolapse, Hypertension			1						1	Abasia; Faecal incontinence; Hypokinesia; Muscle spasms; Myelitis transverse; Pain; Urinary incontinence; Viral infection	FLU3~SANOFI PASTEUR~U1935AA~6~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0254440	04/23/2006	SC	39.0	39		M	04/23/2006	Patient reported dizziness S/P Influenza immunization.  Dizziness described as being 'light' and present while sitting upright with eyes open and closed.  Steady gait while ambulating, strong radial pulses, warm and moist skin at trunk, warm and dry at extremities, no loss of consciousness, not orthostatic, although dizziness subsided while supine.  Pt evaluated by a Physicians Assistant and released to follow up with PCP if symptoms persist.  Possible relation to to current prescribed medication, Zoloft.  Patient placed on Zoloft approximately 2-3 weeks ago and denied any side effects.									Y	04/22/2006	04/22/2006	0	Abnormal Lead III while lying	MIL	MIL	Zoloft	Patient denied	Patient denied any allergies.  Diagnosed with Anxiety and reported a longer thatn recent history of psych meds.			1						1	Dizziness	FLU3~SANOFI PASTEUR~U1936AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0254449	04/24/2006	TX	19.0	19		M	04/21/2006	19 yr old ADA biracial male who received a smallpox vaccine (primary 3 jabs in left arm), along with an influenza vaccine in his right arm on 11/9/05. Prior to Nov 2005, service member describes his health as being very good. He denies any unusual local reactions at his influenza vaccine site. His smallpox vaccine site was assessed around day 7 as a take. Around day 7 or 8, he experienced fatigue, headaches, and body aches, as well as redness and swelling around his SPV site and left axillary lymphadenopathy. Around day 9 he began experiencing chest pain located substernally and on the left side of his sternum. The pain was sharp and intermittent. On Friday, 11/18/05, the pain subsided shortly after onset. It returned again on Sunday 11/20, and lasted all day. He went to work on Monday, 11/21, and ended up going to the hospital when the pain intensified. When the pain started, it was rated as a level 5/10, but on 11/21, it had increased to a level 10/10. The pain was brought on with activity. (Pain occurred with walking slowly on a flat surface for 1 or 2 blocks, 3 METS). The pain became worse when he took deep breaths and when he laid down, especially on his left side. The pain was accompanied by shortness of breath, an increased heart rate, and fatigue. At the hospital, his evaluation was consistent with myocarditis and he was admitted to the ICU. He was monitored and treated with anti inflammatories. He was discharged on 11/24/04 and reports he continued to have chest pain, shortness of breath, fatigue and the sensation of his heart racing with minimal exertion. He was evaluated by Cardiology at BAMC on 11/30/06. At that time, he would describe his health as poor. He took Motrin BID and was on limited duty until Jan 16th, when he was re-evaluated by Cardiology and his medication was changed. He currently reports he experiences a racing heart, shortness of breath and chest pain with minimal exertion and with excitement. (Sometimes he wakes up with symptoms following a vivid dream.) He remains on a profile for limited duty. Symptom: Chest pain. Comment: sharp, intermittent CP on day 9 after SPV and flu vaccine; onset with activity and worse with lying on left side and with deep breaths. Fatigue, malaise>60 days. Comment: fatigue started about 1 week after vaccines, but still present 2 months later. Lymphadenopathy, axillary. Comment: around day 7, left axillary (same side as SPV). Symptom: Tachycardia. Comment: heart racing. Symptom: Dyspnea (shortness of breath); Symptom: Headache, general; Symptom: muscle pain. Plan is to initiat a medical board-see enclosed reports.				Y	Y	3			N	11/09/2005	11/16/2005	7	Diagnostic tests: 11/21/05. CXR conclusion: Normal portable chest. 11/22/05: Transthoracic echo-summary of findings: Left ventricular systolic function was normal. LVEF was estimated range being 55-65%. There were no left ventricular regional wall motion abnormalities. 11/23/05: NM Myocardial perfusion imaging. Impression: There are minimal patchy elevated signal intensity on the delayed enhancement imaged through septum; there is a possibility this is artifact. Recommend further correlation with T2-weighted images. 11/30/05: Echocardiogram-Summary of Findings: Left ventricular systolic function was hyperdynamic. Left ventricular diastolic function parameters were normal. The estimated pulmonary arter systolic pressure was within the normal range. Respirophasic IVC response blunted c/w CVP of at least 15 mmHg. Normal echocardiographic study. 11/30/05. Indium-Mibi Dual Isotope study-Impression: Limited study. Labs: 11/23/05 at 0302. CK 666 (49-397); CK-MB 49.2 (0-4); Troponin I 11.44 (0-0.03); 11/24/05 at 0347. CRP 6.1 (0-5.0); ESR 16 (0-20).	MIL	MIL	NONE		Patellofemoral syndrome			1						1	Chest pain; Dyspnoea; Fatigue; Headache; Heart rate increased; Injection site erythema; Injection site oedema; Lymphadenopathy; Malaise; Myalgia; Myocarditis; Tachycardia	FLUX~UNKNOWN MANUFACTURER~500357P~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4030013~1~~LA~SMALLPOX (DRYVAX)~1	USA	Hospitalisation	Influenza
0254456	04/24/2006	OK	39.0	39		M	04/21/2006	Symptom: Joint pain, multiple joints Comment: migratory joint pain; denies muscle pain but describes bone pain. Pt describes nausea and vomiting and diarrhea as starting around Spring 2003. No triggers identified such as diet changes or stress, but always associated with cycles of joint pain. (Does not know what end to put on toiler...feels like I'm going to throw up and have diarrhea.) No significant weight loss. His Internist recommended an evaluation by a Gastroenterologist, but service member has not followed through at this time. No abdominal pain, constipation, cramping or bloating. No blood in stools. N history of reflex disease, ulcers, liver disease and gall bladder disease. Reports onset of fatigue in 2002. Describes as feeling drained and having no energy to perform usual activities-sometimes dragging when I get up and some days fatigue hits him in the middle of the day. Typically has about 10-15 good days per month where he can carry out duties and activities of daily living without problems. On bay days rates his energy level as being 20% of his baseline prior to 2002. Longest period over past 12 months where he did not feel fatigued was 3 weeks. No particular pattern of fatigue noted. Denies feeling weak or sleepy. Fatigue does not seem to be affected by alcohol or any medications that he has taken. Fatigue does not seem to be triggered or exacerbated by activity but generally he will no even attempt activities on his bad days. On a good day, he can carry out activities without noting a prolonged recovery; during a recent period of fatigue he hired his brothers to clean his yard. Denies associated headaches, visual changes, memory changes or difficulty concentrating, but as previously noted , experiences sore throats and migratory arthralgias. 6/2002-Acute earache prior to onset of migratory joint pains. 6/2002-pharyngitis, acute; experiences sore throats prior to onset of migratory joint pains. 2002-malaise and fatigue; chronic fatigue associated with migratory arthralgias. 2002-pain in joints, migratory joint and bone pain.				Y					N	01/06/2001	06/01/2002	511	ESR-37 (-15); RF-58 (-40); ANA screen-negative; 2002-body scan/CT-neg;9/6/02-Cervical spine series, findings-spine series did not include an odontoid view; CXR-A suggestion of a density is identified in the left apex, which is asymmetrical, suggestion of a left apical mass. A chest CT is recommended. Impression: Apical densities bilaterally which are seen only on the lung windows and probably representing scar formation. Incidental noted is some fatty infiltration of the liver and a 1.0cm cyst in the left lobe. 10/14/02, EMG ordered; ECG-normal; 12;/18/03-sickle cell screen neg.; 8/3/04-ESR 16; Alk Phos 135 (20-125); UA-1+ occult blood, trace protein	MIL	MIL	NONE	NONE	PCN allergy; Eye injury and surgery in 1982; HTN-told he had high BP in 2003; currently not taking any medication; tonsillectomy and adenoidectomy as child; repair of corneal laceration, cataract extraction, removal of intra-ocular foreign body and anterior vitrectomy of right eye-11/82			1						1	Arthralgia; Blood urine; Chest X-ray abnormal; Cyst; Diarrhoea; Ear pain; Fatigue; Hepatic steatosis; Nausea; Pharyngolaryngeal pain; Red blood cell sedimentation rate increased; Vomiting	ANTH~EMERGENT BIOSOLUTIONS~FAV047~6~SC~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~4008215~4~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0254526	04/25/2006	CO	5.0	4		M	04/20/2006	On 3/28/06 Pt came into DR office complaining of fever, vomiting and diarrhea for 3 days. He had been treated with Motrin and Tylenol. ON exam he was lethargic has white nasal discharge, mildly erythematous tonsils and lymphadenopathy. He tested positive for influenza B on Quidel Quickvue.									Y	10/27/2005	03/25/2006	149	Quidel Quickvue influenza A+B test B positive.	PVT	PUB	NONE	NONE	Allergies, asthma			1						1	Bacterial infection; Diarrhoea; Erythema; Lethargy; Lymphadenopathy; Pyrexia; Rhinorrhoea; Tonsillitis; Vomiting	FLU3~SANOFI PASTEUR~V1755AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X1189~4~IM~LL~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0254601	04/26/2006	CA				U	04/21/2006	Initial report received from a health care provider on 4/13/06. A patient, of unknown age and gender, had received an injection of Fluzone SV, lot number not reported and date of vaccination not reported. Per the reporter the patient had developed pancytopenia. The recovery status was not provided, and additional information was not provided. (OMIC)				Y					U					UNK	UNK					200600863	1						1	Pancytopenia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0254755	04/26/2006	OH	1.37	1	.4	M	02/15/2006	Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a 16 month old male patient who experienced a golf ball sized red and purple area at the injection site. At 16 months of age, the patient received the third dose on 12/6/2005. The patient has a past history of a neutrophil count problem at birth, The patient received two prior doses of Prevnar without incident. Indication for Prevnar was immunisation. Product was administered on 12/6/2005. Dose regimen was 1 dose 1 time per day intramuscular. Concomitant therapy included Zantac (ranitidine Hydrochloride), Prevacid (lansoprozaole) and Flu shot (influenza virus vaccine polyvalent). On 12/08/2005, the patient developed a golf ball sized red and purple area on his upper right arm at Prevnar injection site (injection site inflammation), injection site erythema, injection site discoloration. The area was described as warm to the touch and hard, with an open spot (injection site warmth, injection site induration. The patient visited the pediatrician who believed it was an infection and treated the patient with an antibiotic (injection site infection). The reporter stated that the area has improved though there is still a red and purple appearance and a hardness. Additional information has been requested.									U	12/06/2005	12/08/2005	2	UNK	OTH	OTH	Prevacid, Zantac	UNK	Neutrophil count abnormal		HQWYE333613JAN06	1						1	Injection site erythema; Injection site hypersensitivity; Injection site induration; Injection site infection; Injection site inflammation; Injection site warmth; Skin discolouration	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PNC~PFIZER\WYETH~~3~IM~RA~PNEUMO (PREVNAR)~1	USA		Influenza
0254647	04/27/2006	NC	6.0	5		M	04/26/2006	About 2 weeks after receipt of influenza vaccine in Dec 05, 8 YO male developed mildly pruritic Eczematoid lesions on extremities and trunk similar to reaction in 2004, looking back mother noted that previous reaction was about 3/4 weeks following his last flu vaccine, and lasted about 1 year. See comments for description of previous reaction.				Y					Y	12/06/2003	01/01/2006	757	Diagnostic test PST positive =3+, negative =0 food panel for foods most commonly associated with eczema including corn, whole egg, whole milk, peanut, soy, and wheat (does not eat shell fish) was entirely negative. PST for dust mite mix was also negative. Lab 07/29/2004 1715, IgE serum 16.4 (l), CBC W/Diff, WBC blood 5.2, RBC blood 4.56, Hgb blood 12.6, Hct blood 36.5, MCV blood 80.0, MCH blood 27.7, MCHC blood 34.6, RDW blood 12.9, PLT blood 196, MPV blood 11.4 (H), PMN blood 49.0, Lymphs blood 38.5 (H), Mono blood 7.5, Eos blood 4.3 (H), Baso blood 0.7, PMN blood 2.5, lymphs blood 2.0, Mono blood 0.4, Eos blood 0.2, Baso Blood 0.0, Review blood manual diff not performed manual diff not performed. Date ordered 3/1/2005 1005, Date resulted 3/4/2004 1200, collect sample skin upper arm , bacteriology result no growth after 72 hours, gram stain 3/1/04 no PMN present rare mononuclear cells present, rare epithelial cells present, no organisms seen,	MIL	MIL	NONE	NONE	NONE	pruritic eczematoid lesions~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Eczema; Eosinophilia; Laboratory test abnormal; Lymphocytosis; Pruritus; Skin ulcer; Vaccine positive rechallenge; Volume blood increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0254648	04/27/2006	NJ	35.0	34		M	04/21/2006	Cellulitis around injection									Y	04/11/2006	04/19/2006	8	NONE	MIL	MIL	Amoxicillin, Entex	Sinusitis	NONE			1						1	Cellulitis; Injection site reaction	FLU3~SANOFI PASTEUR~U1839AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020072~1~SC~LA~SMALLPOX (DRYVAX)~1	USA		Influenza
0254808	04/30/2006	WI	23.0	23		M	04/30/2006	Increased symptoms of seasonal rhinitis every year after receiving FluMist vaccine. Treatment with Perscription Zyrtec effective.				Y					N	10/01/2003	10/15/2006	1110	none	UNK	UNK	none	none	none			1						1	Rhinitis allergic	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0254832	05/01/2006	AL	3.0	3		F	04/24/2006	Child developed fever early morning of Monday 11/7/06, then status epilepticus. Was brought to ER, was intubated and ventilated. Suffered hypoxic insult. Died 11/8/06. 7/6/06 Received medical records & autopsy report from hospital which reveal COD as status epilepticus with subsequent severe hypoxic/ischemic encephalopathy; cerebral edema with bilateral cerebellar tonsillar herniation; subdural hematoma, small, right lateral cerebellum & asthma (by clinical history).  Stated that status epilepticus possibly related to URI (MRSA).  Temp max 105.8	Y	11/08/2005							N	11/03/2005	11/07/2005	4	WBC 28,500.	PVT	PUB	Flovent; Singulair	Asthma	Asthma			1						1	Asthma; Cardiomegaly; Cerebral ischaemia; Encephalopathy; Hepatic necrosis; Hypoxia; Pneumonia; Pyrexia; Status epilepticus; Subdural haematoma	FLU3~SANOFI PASTEUR~U1830AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0254850	05/01/2006	WV	1.91	1	.9	F	03/02/2006	Reported by child's grandmother when contacted (to recall child for flu vaccine 2nd dose), that child had developed rash 2 days after 1st few vaccine ///. Rash described as looking like water blisters under skin. No itching. Rash covered abdomen from below breast nipples to above navel. Rash lasted 7-8 days. No other effects. Child taken to physician who recommended child not receive flu vaccine dose No. 2. Note: Health department was not notified of child's rash until 3/1/06. Nurse made numerous calls over 4 wk period trying to reach grandparent to get info needed to file Vaers report.				Y					Y	12/20/2005	12/22/2005	2	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Rash papular	FLU3~SANOFI PASTEUR~U1788BA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0254934	05/02/2006	CA	54.0	54		F	04/25/2006	Experienced flu like symptoms (body ache, headache, low grade fever, lose of appetite), within hours of receiving vaccination. Symptoms persisted to varying degrees over the next 3 months. Developed a persistent dry cough after a couple of weeks. Developed a large (tennis ball size) infection in lower back area at site of a previous surgery (performed in 2002). The culture came back as Serratia Marcescens. Required emergency surgery to clean site of infection and use of antibiotics.			Y	Y	Y	2			U	11/17/2005	11/17/2005	0	Culture from infection came back as Serratia Marcescens.	OTH	OTH		Developed flu like symptoms within hours of receiving the vaccine.				1						1	Anorexia; Bacterial infection; Cough; Headache; Infection; Influenza like illness; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61501~1~~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0254940	05/02/2006	OH	1.22	1	.2	M	04/25/2006	Pt developed a papular and vesicular rash over his trunk, neck, head and later, on extremities about 1 week after vaccine. On exam, crusted lesions were noticed. (Pt came to office approx. 5 days after onset of rash).									Y	03/27/2006	04/10/2006	14		PVT	PUB						1						1	Rash papular	FLU3~SANOFI PASTEUR~U1788EA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0255012	05/03/2006	NC	40.0	40		F	05/03/2006	Received a flu shot on 12/8/2005 through my employer.  Within 5 minutes after injection, I was itching profusely, but itching ceased within 15 minutes.  Then, 10 days later, all hell broke loose.  I went into anaphylactic shock on two occasions and have been experiencing a long list of frightening symptoms which are consistent with chemical exposure:  Hives; mysterious rashes (on face, hands, knees and feet)experienced indoors and when exposed to cold temperatures outdoors; difficulty breathing; airway constriction; itchy burning skin; drastic shifts beween the chills and sweating; numbness in extremeties; pins and needles pain in extremeties; nausea; diarrhea; tachycardia; neurocardiogenic syncope; chest pain and tightness;  lightheadiness; constant sensation of wanting to pass out; constant dehydration; rashes and difficulty breathing with products, chemicals and odors the I was NOT previously sensitive to.  I've been living a nightmare for 5 months and have suffered financially as a result of lost working hours and medical bills.  I've seen numerous doctors including my primary care physician, been to the emergency room twice and have had various blood labs drawn.  I've been diagnosed as having an ongoing allergic reaction, but have received little to no help or direction for treatment from the medical community.  My pcp informed me that she had no idea of how to test for chemical poisoning or toxicity?  I asked for a mercury level test to be done via blood and am still awaiting results.  I also had a skin/tissue analysis done to see what toxins my body was releasing:  I tested positive for mercury, aluminum, copper and arsenic.  In addition, I've done much research on the chemicals used to preserve the flu vaccine and it's horrifying!!!  If I knew then, back in December, what I know know, I would have never received the flu shot.  I'm appalled, to say the least, that the FDA, the CDC and our governments would allow such toxic chemicals to be used in a vaccine that the masses receive.  Currently, my health has improved a bit, but I await a long road to recovery before my immune system is back on track.  I require various medications to suppress/control the allergic reactions and to prevent cardiac dysfunction (tachycardia and NCS).			Y	Y					N	12/08/2005	12/17/2005	9	1. Blood labs indicating elevation of neutrophils. 2. Skin test revealing positives to 3 metals and arsenic. 3. Awaiting blood lab results for mecury/lead levels.	UNK	UNK		NONE	1) Tachycardia 2) Seasonal allergies/ chronic sinusitus Medical records state hypercholesteremia, miral valve prolaps, AV node re-entry tachycardia. msv			1						1	Anaphylactic shock; Chest discomfort; Chest pain; Chills; Dehydration; Diarrhoea; Dizziness; Dyspnoea; Hyperhidrosis; Hypoaesthesia; Laboratory test abnormal; Nausea; Paraesthesia; Pruritus; Rash; Syncope; Tachycardia; Throat tightness	FLU3~SANOFI PASTEUR~U1945AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0044216	05/08/2006		34.0			M	03/24/2006	Initial information received on 26Sept05. Case linked to nine other cases. It was reported that a 34 yr old pt developed Guillain Barre Syndrome after receiving Menomune (lot number, site and route of admin not reported) on 30Nov90. On 12Dec90 the pt developed weakness which began in the feet and moved upwards. the pt was unable to walk and dropped things. The pt had mild upper respiratory infection symptoms one week prior to admission. An IgM on 17Dec90 was abnormal and consistent with Guillain Barre Syndrome. The pt received five plasmaphoresis exchanges. No further information reported. No further information expected. Other nine cases received are U200000490, U200000491, 2004-01816, 200501908, 200501909, 200501910, 200501911, 200501912, 200501913. Follow up information received on 19Dec05. The pt was a male. Vaccinations received on 30Nov05 include an injection of Menomune A/C/Y/W-135, lot number 0D21085; an injection of Influenza vaccine, lot number 0511019 (which does not correspond to manf lot number); an injection of influenza vaccine, lot number 0511019 (which does not correspond to a manf lot number); an injection of TD ADS Adult, lot number 9L11011; an injection of Adenovirus vaccine, lot 4888220; an injection of Measles and Rubella virus vaccine, lot number 0302R; an injection of mumps virus vaccine, lot number 02106 and OPV, lot 0611C.					Y	0				11/30/1990	12/12/1990	12	An IGM on 17Dec90 was abnormal and consistent with Guillain Barre Syndrome.	UNK	UNK			The pt had mild upper respiratory symptoms one week prior to admission. He also has a history of positive PPD.		200501914	1						3	Asthenia; Coordination abnormal; Gait disturbance; Guillain-Barre syndrome; Movement disorder	FLU3~SANOFI PASTEUR~0511019~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~3|MEN~SANOFI PASTEUR~0D21085~UNK~~UN~MENINGOCOCCAL (MENOMUNE)~3|MER~MERCK & CO. INC.~0302R~UNK~~UN~MEASLES + RUBELLA (MR-VAX II)~3|MU~MERCK & CO. INC.~02106~UNK~~UN~MUMPS (MUMPSVAX II)~3|OPV~PFIZER\WYETH~0611C~UNK~PO~MO~POLIO VIRUS, ORAL (NO BRAND NAME)~3|TD~AVENTIS PASTEUR~9L11011~UNK~~UN~TETANUS DIPHTHERIA (NO BRAND NAME)~3	USA	Hospitalisation	Influenza
0255217	05/09/2006	FL	10.0	10		F	05/04/2006	Approx 15 mins after flu vaccine administration pt started getting pruritic, erythematous lesions on face and torso. 2tsp Benadryl given and pt waited inside clinic 30 mins.									Y	05/04/2006	05/04/2006	0	NONE	UNK	UNK	NONE	Left ear pain and diarrhea	NONE			1						1	Erythema; Rash pruritic	FLU3~SANOFI PASTEUR~U1937AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0255323	05/11/2006		68.0	68		F	05/08/2006	Information has been received concerning a 68 year old female with rheumatoid arthritis, osteoporosis and pain who on 11/25/2005 was vaccinated (route unknown) with a dose of pneumococcal 23v polysaccharide vaccine (lot # unknown) and a jab of influenza virus vaccine unspecified. Concomitant therapy included diclofenac, leflunomide, tramadol HC1 (Tramadolor), cholecaloiferol, risedronate sodium (Actonel) and etanercept Enbrel. It was reported that a patient was a participant in a study. In the evening of 11/25/2005 the patient also had a dose of etanercept Enbrel. Approximately three months post initiation of etanercept Enbrel therapy and one day after Saturday 11/26/2005 receiving the Pneumococcal 23v polysaccharide vaccine, the patient started feeling ill (malaise), pain in joints (knees, elbows, all over body, arthralgia), and wasn't able to move (movement disorder). On 11/27/2005, the patient called the ambulance and was accepted as an inpatient on 11/28/2005 (2 days later) for an unknown period of time. Therapy with etanercept Enbrel was discontinued. The patient was diagnosed with polyarticular septic arthritis. Treatment included intravenous antibiotics unspecified. It was reported that the patient was re admitted to the hospital approximately one month later, additional details were not provided. It was reported that the septic arthritis was considered severe and it persisted. The reporter suspected the event was related to therapy with etanercept Enbrel and Pneumococcal 23v polysaccharide vaccine was identified as co suspect. The temporal relationship between the onset of the event and the administration of therapy suggests that a causal relationship is possible, however, causality is confounded by the concurrent use of diclofenac, leflunomide, tramadol HCL Tramadolor, and Pneumococcal 23v polysaccharide vaccine. Additional information is not expected.					Y				U	11/25/2005	11/26/2005	1	Procedure unspecified awaiting results for diagnosis of septic arthritis, lymphocyte count 9/19/2005 1.81% 12/14/05 2.07%, neutrophil count 9199/05 14.8% 12/14/05 4.99% 12/14/05 22.52% 09/19/05 7.72%, WBC count 09/19/05 15.92% 12/14/05 7.78% 09/19/05 10.45% 12/14/05 24.2%.	OTH	OTH	Cholecaloiferol, Diclofenac, Enbrel, Leflunomide, Actonel, Tramadolor		Rheumatoid arthritis, Osteoporosis, Pain		WAES0605USA00011	1						1	Arthralgia; Arthritis bacterial; Lymphopenia; Malaise; Movement disorder; Neutropenia; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0255384	05/12/2006	CA	10.0	10		M	04/27/2006	The child was participating in a post-marketing evaluation of the safety of influenza virus vaccine live, intranasal (Flumist) in healthy children and healthy adults 5 through 49 years of age. A report was received a Bell's Palsy coincident to FluMist. A ten year old male received FluMist on 18Nov05 and was diagnosed with Bell's Palsy coincident to FluMist. A ten year old male received FluMist on 18Nov05 and was diagnosed with Bell's Palsy on 20Nov05. On 16Nov05, the child was seen in the ER for a headache at the left occiput (pain radiating to the left jaw, tingling on left side of face, runny nose, and nasal congestion. At that time, the child denied numbness or ear pain, but did mention being hit in the head with a dodge ball two weeks prior to that ER visit. On 20Nov05, the child was unable to fully close the left eyelid, could not move the left side of the mouth or face, had decreased sensation in the left side of the face and was diagnosed with mild Bell's Palsy. The child was able to raise his eyebrows and the rest of the neurological examination was within normal limits. The child was treated with prednisolone 30mg twice a day for ten days (to be weaned as per protocol). And acyclovir 400mg by mouth five times per day for ten days. A recommendation was made to check the child in one month; however, the recommendation was not adhered to and no visits were on record since 20Nov05. The outcome of the event was not reported. The reporter assessed the event as possibly related to Flumist. Follow-up: 08 Dec 06 per the investigation, since 30 Jun 06, there was no mention made of BELL's Palsy Tx. Reminder: This case ongoing from FM025 which is a study.									Y	11/18/2005	11/20/2005	2		OTH	OTH			Febrile seizure		MEDI0004521	1						1	Eyelid retraction; Facial palsy; Headache; Nasal congestion; Paraesthesia; Rhinorrhoea; Sensory disturbance	FLUN3~MEDIMMUNE VACCINES, INC.~IN500391P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0255385	05/12/2006	CA	40.0	40		M	04/27/2006	The patient was participation in a post marketing evaluation of the safety of influenza virus vaccine live, intranasal flu mist in health children and healthy adults 5 through 49 years of age. A report was received of Bells palsy, neck pain, shoulder pain, and discomfort around the right ear coincident of FluMist. A 40 year old male with a history of migraines, anxiety, arthroscopic surgery, and chronic back pain, received FluMist on 11/25/2006 and developed Bells Palsy on 12/3/05. The patient reported several days of neck and shoulder pain that occasionally radiated to the right arm (no weakness or numbness) and one to two days of discomfort around the right ear. The patient was taking hydrocodone acetaminophen for pain due to recent arthroscopic surgery in 11/21/05. ON 12/14/05, the event of Bells Palsy was considered resolved. The outcome for the events of neck and shoulder pain were not provided. The reporter assessed the event of Bells palsy as possibly related to FluMist. The reporter did not provide a statement of causality for the events of neck and shoulder pain. This case is linked to MEDI0004189 (patient experienced pneumonia after receiving FluMist.									Y	11/25/2005	12/03/2005	8		OTH	OTH	Vicodin		Migraine, Anxiety, Chronic back pain, Arthroscopic surgery.		MEDI0004507	1						1	Anxiety; Back pain; Discomfort; Facial palsy; Migraine; Neck pain; Pain; Shoulder pain	FLUN3~MEDIMMUNE VACCINES, INC.~IN500394P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0255386	05/12/2006		43.0	42		F	04/26/2006	Post Marketing Evaluation of the Safety of Influenza Virus vaccine live intranasal FluMist in healthy children and healthy adults 5 through 49 years of age. This is a 43 year old female who received FluMist on 11/14/05 and was diagnosed with Guillain Barre syndrome. On 1/26/06 at approximately 2am, the patient woke up and walked to the bathroom. She reported having difficulty using her right hand and almost fell down while she was walking to the toilet. She was seen at a hospital and was found to have a low potassium level of 2.8 which was repleted to 3.2. She also complained of a headache and neck stiffness, head CT was negative and a lumbar puncture was negative aside from and elevated CSF protein of 67. She was discharged home. A week prior to this event, she complained of flu like illness. At home, she was unable to walk and became almost quadriplegic. She was then brought to the emergency room. In the ER, neurology was consulted and an EMG was done with findings that were was strongly suggestive of Guillain Barre syndrome. She was then given Dilaudid 1mg IV and intravenous immunoglobulin IVIG was started at 400mg KG day to complete a total of 5 days. Other treatment include plasmapheresis. During the course of her hospitalization, she was also diagnosed with depression and was placed on Prozac (Fluoxetine). She was discharged after 31 days to a skilled nursing facility. In the SNF, Dilaudid was continued for pain management together with Fentanyl patch. As of 4/18/06, the rehabilitation notes indicated that the patient remains dependent on all activities of daily living although she continues to show increased strength for trunk and hip control. The SNF consult notes also indicated that she does not have sufficient motor neuron recovered to give significant gains in functional mobility. Physical therapy in ongoing. Medications in the SNF included. Subcutaneous Heparin, Tylenol, Nevacor (Lovastatin), Prilosec (omeprazole), Quinine sulfate, Elavil (amitriptyline), Fentanyl patch, Dilaudid, Ativan (alprazolam), Colace (docusate sodium), Senna, Dulcolax (bisacodyl), milk of magnesia, oil enema, Nasarel and artificial tears. The patient has not yet recovered. The reporter has assessed this event as not related to FluMist.			Y	Y	Y			Y	N	11/14/2005	01/26/2006	73	01/26/06 Alkaline phosphatase 42; ALT 40; Amylase 47; Anion gap 11. 01/27/06 Anion gap 5. 01/26/06 AST 16; Bicarbonate 30. 01/27/06 Bicarbonate 28. 01/26/06 Bilirubin total 0.6; direct 0.2. 01/26/06 BUN 16; 01/27/06 BUN 13. 01/26/06 Calcium 9.2. 01/27/06 Calcium 9.6. 01/26/06 Chloride 93. 01/27/06 Chloride 102. 01/26/06 CK 19; 01/27/06 CK 35. 01/26/06 CK index 1.1. 01/26/06 CKMB 0.2. 01/26/06 Creatinine 0.8. 01/27/06 Creatinine 0.7. 01/26/06 CSF Glucose 56; 01/26/06 CSF gram stain negative. 01/26/06 CSF protein. 01/26/06 CSF RBC 30. 01/26/06 CSF WBC 2. 01/26/06 EKG normal sinus rhythm. Rate of 61 with an isolated T-wave inversion at 3, but no ST abnormalities. 01/26/06 EMG suggestive of Guillain Barre synd. examination nerve conduction study and needle EMG all strongly suggestive of GBS. 01/26/06 Eosinophils 1%. 01/27/06 1%. 01/26/06 Glucose 101. 01/27/06  Glucose 96. 01/26/06 Head CT negative; 01/26/06 Hematocrit 40.6. 01/27/06 Hematocrit 39.8. 01/26/06 Hemoglobin 13.6. 01/27/06 Hemoglobin 13.9. 01/27/06 INR 1.1. 01/26/06 Lipase 304. 01/26/06 LP (lumbar puncture) negative. Colorless CSF with 2 WBC and 30 RBC; elevated CSF protein of 67; glucose normal at 56; no organisms on gram stain. 01/26/06 Lymphocytes 39%. 01/27/06 Lymphocytes 29%. 01/27/06 Magnesium 2.2. 01/26/06 Monocytes 7%. 01/27/06 Monocytes 5%. 01/26/06 Neutrophils 50%. 01/27/06 Neutrophils 65%. 01/27/06 Phosphorus 3.3. Platelets 01/26/06 353. 01/27/06 Platelets 400. 01/26/06 Platelets 2.8 was repleted and value increased to 3.2 on same day below normal. 01/26/06 Potassium 3.2. 01/27/06 Potassium 4.0 was repleted and value increased to 3.2 on same day below normal. 01/27/06 PT 11.4. 01/27/06 PTT 24.8; 01/26/06 Sodium 134. 01/27/06 Sodium 135; 01/26/06 Total protein total 7.1; albumin-4.0 pending. 01/26/06 Urinalysis 3+ ketones, 3+ epi and 1+ mucous. 01/26/06 WBC 10.1; 01/27/06 10.1.	OTH	OTH	Lovastatin, Omeprazol, Potassium, Chloride, Metolazone		Past surgical history: right elbow surgery, left shoulder surgery. Past disease: hyperlipidemia; esophageal acid reflex; vaginal hysterectomy; appendectomy, cholecystomy, Tonsillectomy.		MEDI0004505	1						1	Abasia; Alanine aminotransferase increased; Blood alkaline phosphatase increased; Blood bicarbonate decreased; Blood bilirubin increased; Blood calcium increased; Blood chloride increased; Blood creatinine increased; Blood glucose increased; Blood sodium increased; Blood urea increased; CSF test abnormal; Depression; Gait disturbance; Guillain-Barre syndrome; Haematocrit decreased; Headache; Hypokalaemia; Hypokinesia; Influenza like illness; Laboratory test abnormal; Lipase increased; Monocytosis; Movement disorder; Musculoskeletal stiffness; Neutropenia; Pain; Platelet disorder; Quadriplegia; Red blood cell abnormality; White blood cell disorder	FLUN3~MEDIMMUNE VACCINES, INC.~IN500393P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0255440	05/15/2006	NJ	7.0	7		M	05/15/2006	Developed fever 101-103 within 12 hours of Fluzone. Seen 3 days later. Diagnosed viral pharyngitis. Seen again on day 7/10/12/05, with erythema and swelling of M-P joints 2-5 in both hands. DX'd with acute arthritis, possibly lymes W/- serology. Had strep throat x 2 on 3/30/06. and on 4/11/06 TX'd amoxil and Duricef respectively, but on 4/11/06 was noted to have HR 52. EKG complete heart block, admitted to hospital cardiac pacemaker placed. Note EKG at birth was normal sinus rhythm. Discharge summary states bradycardia, fever, heart block. msv					Y				N	05/02/2005	05/02/2005	0	EKG complete heart block, admitted to hospital, cardiac pacemaker placed, note EKG at  birth was normal sinus rhythm Medical records state increased sed rate. msv	PVT	UNK			Discharge summary states pharyngitis. msv			1						1	Arthritis; Atrioventricular block; Bacterial infection; Bradycardia; Cardiac disorder; Erythema; Heart rate irregular; Joint swelling; Pharyngitis; Pharyngolaryngeal pain; Pyrexia; Red blood cell sedimentation rate increased; Viral infection; Arthritis; Atrioventricular block; Bacterial infection; Bradycardia; Erythema; Joint swelling; Pharyngitis; Pharyngolaryngeal pain; Pyrexia; Viral infection	FLU3~SANOFI PASTEUR~U1753AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1753AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0251012	05/17/2006	OH	1.31	1	.3	M	05/12/2006	Information has been received from a physician concerning a 16 month old white male with a history of prematurity(born at 32 weeks gestation) who on the morning of 20 December 2005, at 15 3/4 months of age, was vaccinated subcutaneously in the right thigh with the first dose of varicella virus vaccine live (Oka/Merck) (lot # 649486/0419R). There was not concomitant therapy. The physician reported that on the morning of 03 January 2006, the patient presented to his office with papulovesicular lesions and umbilicated lesions over his body. On 09 January 2006, the patients papulovesicular lesions and umbilicated lesions resolved. No further information is available.				Y					Y	12/20/2005	01/03/2006	14	UNK	PVT	PUB	NONE		Prematurity		WAES061USA03628	1						2	Rash papular; Rash papular	FLU3~AVENTIS PASTEUR~U787GA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|BCG~SANOFI PASTEUR~~UNK~~~BCG (MYCOBAX)~2|VARCEL~MERCK & CO. INC.~0419R~1~SC~~VARICELLA (VARIVAX)~2	USA	Emergency room visit	Influenza
0256124	05/17/2006	CA	1.01	1	.0	M	05/12/2006	Information has been received from a physician concerning a 35 month old white male pt with no pre-existing allergies or medical conditions, who on 19Nov03 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot 646235/0828N). Concomitant vaccine therapy administered on the same day, 19Nov03 included a first SC dose in the right arm of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 641629/0667N) and a first IM dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (lot U1091AA) administered in the left arm. It was noted that the pt developed a rash and was seen in the office with a three day history of rash on his inner thigh and knee. Onset was reported as 11OCT05. The rash was reported as somewhat itchy and there was no fever. The rash was in clusters of vesicles on erythematous base and isolated to L-3 dermatome on left lower extremities. As per the pt's mother the pt had varicella vaccine with routine immunizations at 1 year of age. There was no history of wild type illness. Follow up information received on 28Oct05 contained the following adverse experience: respiratory infection illness (approx 07Oct05). Additional information has been requested. The physician also reported a case of chickenpox in the pt's unvaccinated family members (female twins) (WAES0506USA00501 and 0506USA00815).				Y					N	11/19/2003	10/07/2005	688	UNK	PVT	PVT			NONE		WAES0506USA00565	1						1	Erythema; Rash pruritic; Rash vesicular; Respiratory tract infection	FLU3~SANOFI PASTEUR~U1091AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0667N~1~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0828N~1~SC~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0256883	05/17/2006	AR	2.0	2	.1	F	05/12/2006	Information has been received from a registered nurse concerning a 26-month-old female who on 10/26/2005, was vaccinated SC in the right thigh with a 0.5 mL dose of varicella virus vaccine live (oka/Merck) (lot #65117/0428R). Concomitant vaccination on the same day included a dose in the left thigh of influenza virus vaccine (unspecified) (lot #U1743IA) and a first dose in the left thigh of hepatitis A vaccine (inactive) (manufacturer unknown) (Havrix) (lot #AHAVA018BA). There was no illness at the time of vaccination. On 11/09/2005, the patient developed two lesions at the injection site. It was noted that the patient's mother, who had a history of chickenpox, was pregnant and it was unknown if she had chickenpox at that time. Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information was received from the registered nurse who reported that the mother called on 11/09/2005 and stated that her daughter had red spots on the right upper thigh which were hard. The patient did not have a fever. The reporter was not able to provide any further information. No further information is expected.				Y					U	10/26/2005	11/09/2005	14	body temp 11/09/05-afebrile	PVT	OTH			UNK		WAES0511USA01859	1						1	Erythema; Injection site reaction; Skin disorder; Skin ulcer	FLUX~UNKNOWN MANUFACTURER~U1743IA~UNK~~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVA018BA~1~~LL~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~6511770428R~UNK~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0256910	05/17/2006	WI				F	05/12/2006	Info has been received from a physician concerning a white female with a history of recurrent ear infections who on 11/7/05, was vaccinated, SC, with the 1st 0.5 mL dose of varicella virus vaccine live (lot 650223/0426R). Concomitant vaccinations given on that same day included the 4th, IM, dose of Prevnar (lot A98341H) and the 1st, IM, dose of influenza virus whole virion 3v vaccine inactivated (Fluzone) (lot U1743KA). The pt developed a red, bumpy (raised lesions) rash at the injection site that did not appear to be classic chickenpox. Unspecified medical attention was bought and the physician was trying to determine if the pt should be isolated. No lab/diagnostic tests were performed. Subsequently, the pt's rash resolved. Additional info is not expected.				Y					Y	11/07/2005	11/17/2005	10	NONE	PVT	OTH			Ear infection		WAES0511USA03208	1						1	Injection site erythema; Injection site swelling; Skin ulcer	FLU3~SANOFI PASTEUR~U1743KA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A98341H~4~IM~~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0426R~1~SC~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0256937	05/17/2006	NE	1.26	1	.3	F	05/12/2006	Information has been received from a registered nurse concerning a 15-month-old white female with no known allergies or medical history, who on 11/18/2005 was vaccinated subcutaneously in the right with a first dose of varicella virus vaccine live (Oka/Merck) (lot #646669/626R). Concomitant vaccination on the same day included an intramuscular third dose in the right thigh of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (MSD) (lot #652710/0695R) and an intramuscular first dose in the left thigh of influenza virus split virion 3v vaccine inactivated (Fluzone) (lot #U1765BA). There was no other concomitant medication. There was no illness at the time of vaccination. The mother called the office to report that the child developed three vesicular lesions at the injection site on 11/29/2005. Unspecified medical attention was sought and no diagnostic laboratory tests were performed. At the time of the report, the patient was recovering. A product quality complaint was not involved. Follow-up information was received from the registered nurse who reported that the child's mother called the office in the morning on 11/29/2005 to report that the patient had redness at the injection site initially and had bubbly bumps that were very small. The mother was instructed to monitor the symptoms and was told it was probably just a reaction. The patient recovered on an unspecified date.				Y					Y	11/18/2005	11/29/2005	11	NONE	PVT	PVT			NONE		WAES0512USA00206	1						1	Injection site erythema; Injection site vesicles	FLU3~SANOFI PASTEUR~U1765BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~6527100695R~3~IM~RL~HIB + HEP B (COMVAX)~1|VARCEL~MERCK & CO. INC.~6466690626R~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0256938	05/17/2006	NE	1.24	1	.2	M	05/12/2006	Information has been received from a health professional concerning a 14 month old white male, with no medical history and no allergies, who on 11/11/2005 was vaccinated with a 0.5 ml subcutaneous first dose in the right thigh of varicella virus vaccine live (Oka/Merck) (Lot #646669/0626R). Concomitant vaccine administered on the same day included a third intramuscular dose in the right conj-hepatitis B vaccine (MSD) (Lot #652498/0643R), and a first intramuscular dose in the left thigh of influenza virus split virion 3v vaccine inactivated (Fluzone) (Lot #U1767CA). There was no illness at the time of vaccination. It was reported that, on 11/15/2005, the patient's mother notified the reporter that on 11/13/2005 (previously reported on 11/14/2005) the child developed a fever of 103.4 F and extreme pain when the child tried to us the leg in which the vaccine was given. The mother was advised to give the child over-the-counter ibuprofen. The patient was seen in the office on 11/16/2005 and the fever was down to 99.6. On 11/18/2005, the fever and leg pain had resolved, but the child did develop a mild red rash on his trunk. At the time of the report the patient was recovering. The reporter assumed that the child had since recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow up information from a health professional indicated that no treatment was provided except for ibuprofen and warm compresses. It was reported that the patient recovered. Additional information is not expected.				Y					Y	11/11/2005	11/13/2005	2	Test:                 Date             Value     Normal Range                    Comment  Basophil count 11/14/05  1.1%         0.0-1.0 basophil count 11/14/05    0.06 thous  eosinophil count 11/14/05  0.2%         0.0-3.0 eosinophil count 11/14/05  0.01 thous Hemoglobin        11/14/05  11.5 g/dl 1   10.3-12.4 Lymphocyte count 11/14/05 59.3%        20.0-64.0 lymphocyte count 11/14/05   3.27 thous 1.9-6.8 monocyte count    11/14/05  0.81 thous neutrophil count   11/14/05  24.7             21.0-67.0 neutrophil count    11/14/05  1.36 thous  1.6-8.3 platelet count        11/14/05  181 thous   219-452 body temp             11/15/05   103.4F body temp              11/16/05  99.6 CSF monocyte count 11/14/05 14.7%      5.0-11.0 erythrocyte                11/14/05   45mm/h 0-15 White blood cell         11/14/05                          few atypical lymphs mean corpuscular      11/14/05    25.1 pg 23.2 27.5 mean corpuscular      11/14/05   32.5 g/dL 31.9-35.0 mean corpuscular vol 11/14/05   77.1 fL   70.5-81.2 mean platelet vol       11/14/05   9.4fL nucleated erythrocyte 11/14/05   0 WBC   0-100 red blood cell count    11/14/05   4.59 milli  4.1-5.00 RDW                            11/14/05  38.4 fL RDW                             11/14/05 13.6% serum C-reactive protein 11/14/05 <0.3 mg/dl  0.0-0.7 WBC count                   11/14/05   5.51 thous 6.2-14.50 white blood cell            11/14/05       -  Scan of smear confirms automated differential hematocrit                     11/14/05   35.4%    30.9-37.0	OTH	OTH			NONE		WAES0512USA00207	1						1	Laboratory test abnormal; Pain; Pyrexia; Rash erythematous; Difficulty in walking; Pyrexia; Red blood cell sedimentation rate increased; Vaccination complication	FLU3~SANOFI PASTEUR~U1787CA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~6524980643R~3~IM~RL~HIB + HEP B (COMVAX)~1|VARCEL~MERCK & CO. INC.~6466690626R~1~SC~RL~VARICELLA (VARIVAX)~1|FLU3~SANOFI PASTEUR~U17871A~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|HBHEPB~MERCK & CO. INC.~652498/0643R~3~IM~~HIB + HEP B (COMVAX)~2|VARCEL~MERCK & CO. INC.~646669/0626R~1~SC~~VARICELLA (VARIVAX)~2	USA	Emergency room visit	Influenza
0257161	05/17/2006	OR	25.0	25		F	05/12/2006	Information has been received from a registered nurse concerning a 25 year old white female with allergies to vancomycin and latex, and with Hirschsprung's disease and short-bowel syndrome who on October 30, 1995 at ; was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). There was no illness at the time of vaccination. Concomitant therapy that day included influenza virus split virion 3V vaccine inactivated (Fluzone (influenza virus split virion 3v vaccine inactivated)) (has received in the past). On October 30, 1995 at 3:40 PM, 10 minutes after injection, the patient became quite agitated and developed pain in the throat. It was noted that the patient was scratching her skin vigorously. The patient was given 0.3cc of 1:1000 dilution epinephrine. The symptoms resolved rapidly on October 30, 1995. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations. It was also noted that the patient had a reaction to hepatitis B virus vaccine rHBsAg (yeast) (WAES #0601USA01543). No additional information is expected.				Y					Y	10/30/1995	10/30/1995	0	NONE	PVT	OTH	Epinephrine		Allergic reaction to antibiotics; Latex allergy: Hirschsprung's disease; short bowel syndrome	~Hep B (no brand name)~~0.00~In Patient	WAES0601USA02315	1						1	Agitation; Pharyngolaryngeal pain; Pruritus	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~~1~~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0257378	05/17/2006		1.07	1	.1	F	05/12/2006	Information has been received from a health professional concerning a 14 month old female with a normal immune status who on 10 January 2006, was vaccinated subcutaneously in the left arm with a 0.5ml dose of varicella virus vaccine live (Oka/Merck) (lot #645164/0064R). Concomitant therapy that day included Hib conj vaccine (OMPC) (manufacturer unknown), measles mumps rubella vaccine (MSD) and influenza virus vaccine (unspecified). The patient's mother called to report that on 16 February 2006, her daughter developed a line of tiny vesicular lesions on her left side. She described the line as 2-3 inches wide and about 6 inches long. From the description the nurse felt this may be shingles. It was noted that the patient had not been in for an exam. No labs were done. At the time of this report the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.				Y					N	01/10/2006	02/16/2006	37	NONE	OTH	OTH			UNK		WAES0602USA04554	1						1	Rash vesicular	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~MERCK & CO. INC.~~UNK~~~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0064R~UNK~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0257402	05/17/2006					M	05/12/2006	Herpes Zoster Information has been received from a registered nurse (RN) concerning a male in his 60s year who on 20-JAN-2006 was vaccinated with a 0.5ml dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccinations administered on that same day included a dose of measles virus vaccine live (Enders-Edmonston)(+) mumps virus vaccine live (Jeryl Lynn((+) rubella virus vaccine live (Wistar RA 27/3)(MSD), a dose of influenza virus vaccine (unspecified) and diphtheria toxoid (+) tetanus toxoid. The RN reported that in 2006 the patient developed a rash. The patient went to a free clinic where a diagnosis of shingles was made. At the time of this report, the outcome was unknown. Additional information has been requested.				Y					U	01/20/2006			Unknown	OTH	OTH			Unknown		WAES0602USA05523	1						1	Herpes zoster	DTOX~UNKNOWN MANUFACTURER~~UNK~~~DIPHTHERIA TOXOIDS (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~~TETANUS TOXOID (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~~UNK~~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0257414	05/17/2006	NY	1.01	1	.0	F	05/12/2006	Information has been received from a health professional concerning a 14 month old female with a history of bronchiolitis and no known allergies, who on 12 December 2005 (also reported on 05 December 2005), was vaccinated subcutaneously in the right arm with a 0.5 Ml dose of varicella virus vaccine live (lot # 650231/1114P). Concomitant vaccination that day included a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CMR197) (Prevnar), a dose of influenza virus vaccine (unspecified) and a dose of measles-mumps-rubella vaccine. Concomitant therapy included diphenhydramine hydrochloride (Benadryl). A rash did not occur at the site of injection post vaccination. On 21 February 2006, she had developed a vesiculo-papular rash, also described as a diffuse papular rash, on her face, trunk and extremities. On 22 February 2006, the patient was seen by the physician. The patient was had greater than 100 lesions on her face, trunk and upper arms. Some burrows were noted. The patient was afebrile. The physician assumed it was scabies and the patient was treated with permethrin (Elimite). The patient did not get better and she was seen again on 27 February 2006. She still had a diffuse papular rash, many of which were crusted. The patient's diagnosis was possible varicella. VZVID isolates were requested by the physician. On 28 February 2006, the specimen was obtained from a papule. The specimen was inadequate, negative for b-globuin, no strain was identified. It was noted that there had been no recent exposure to chickenpox or shingles. At the time of the report the patient had not yet recovered. There was no product quality complaint involved. Diffuse papular rash was considered to be an other important medical event. Additional information has been requested. (OMIC)				Y					N	12/12/2005	02/21/2006	71		OTH	OTH	Benadryl; Elimite		Bronchiolitis		WAES0603USA00125	1						1	Rash papular	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~~UNK~~~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1114P~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0255765	05/18/2006	NC	0.69	0	.7	F	05/15/2006	Initial report received on 09May06 from an investigator. A 13 month old female subject developed profound sensorineural hearing loss bilaterally after she had received an IM, right thigh, second dose injection of Fluzone No Preservative Trival A & B Subvirion U, lot number U1743IA, on 07Dec05. At nine to ten months of age, the parent had noticed that the baby was not responding to sound. The SAE was considered by the investigator to be a persistent or significant disability/incapacity. The onset set date of the SAE was reported as 04May06, 148 days following administration of the second dose of the study vaccine. At the time of this report, the subject had not recovered. According to the investigator, the event was related to the study vaccine.								Y	N	12/07/2005	05/04/2006	148		UNK	UNK					200601070	1						1	Deafness; Hypoacusis	FLU3~SANOFI PASTEUR~U1743I~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0255799	05/18/2006	MD	21.0	21		M	05/18/2006	A FEW MINUTES AFTER OVERSEAS IMMUNIZATIONS COMPLETED HE SAID HE WANTED THE TYPHOID TODAY ALSO. NO TYPHOID GIVEN TODAY.  WRITING UP CHARGE PAPERS-OBSERVED CLIENT BECAME VERY PALE, SAW BLACK SPOTS AND FELT FAINT.  SITTING IN CHAIR-DRINKING OJ, MOIST AND COOL CLOTH TO FOREHEAD & WRISTS-PERFUSE PERSPIRATION-ASSISTED FROM CHAIR AND LAID DOWN, ELEVATED FEET ON PILLOWS-CALLED NURSE TO HELP MONITOR AND INCIDENT REPORT.  BP 118/76 P 73 @2:48 PM ALERT & ORIENTED X3.  ATE CRACKERS AND OJ. DANGLED, BP 106/80, P68.  STOOD WITH ASSISTANCE.  TO CAR WITH FRIEND DRIVER @3:45 PM. AFTER EVENT, STATED HE FELT WEAK WHILE OBSERVING FRIEND GET SHOTS BEFORE HE RECEIVED HIS.									Y	04/28/2006	04/28/2006	0	VITAL SIGNS	UNK	UNK	NONE	NO TEMP ELEVATION.  C/O SORE THROAT A FEW DAYS AGO-FINALS WEEK AT COLLEGE-TIRED.	NONE			1						1	Asthenia; Pallor; Syncope; Vitreous floaters	FLU3~SANOFI PASTEUR~U1881AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB105AA~1~IM~LA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~Y0576~5~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MEN~SANOFI PASTEUR~UE515AA~1~SC~LA~MENINGOCOCCAL (MENOMUNE)~1|TDAP~SANOFI PASTEUR~C2340AA~1~IM~RA~TDAP (ADACEL)~1|YF~SANOFI PASTEUR~UE813AA~1~SC~LA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0255819	05/19/2006	VA	23.0	23		M	05/13/2006	23 year old male who presented with chest pain 11 days following his smallpox immunization. EKG and echo are consistent with mild myocarditis. Pt is being transferred to hospital. Per 60 day follow up: After the patient left foreign country to return to the US, I have not heard any further reports about this patient. I am unsure of where he is at this time.					Y	2			U	05/01/2006	05/12/2006	11	EKG ST increase, V5 V6, increased troponin, Echo Global hypokinesis.  Medical records state increased ERS, elevated AST. msv	MIL	MIL	PPD		Medical records state cold, cough, fever. msv			1						1	Aspartate aminotransferase increased; Chest pain; Electrocardiogram abnormal; Hypokinesia; Laboratory test abnormal; Myocarditis; Red blood cell sedimentation rate increased	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~RA~HEP B (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4020072~1~~LA~SMALLPOX (DRYVAX)~1	USA	Hospitalisation	Influenza
0255821	05/19/2006	DC	3.0	2	.6	M	03/02/2006	Ataxia possible cerebellitis. Required observation only. Medical records state leg pain. msv					Y	2			Y	12/30/2005	01/02/2006	3	Medical records state H&H decreased, abnormal EKG. msv	PVT	PVT			Medical records state speech problems, drooling, croup. msv Discharge summary states sinus infection, conjunctivitis, viral infection. msv			1						1	Arthralgia; Cerebellar syndrome; Coordination abnormal; Electrocardiogram abnormal; Haematocrit decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U1867DA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0255909	05/19/2006	IN	1.04	1	.0	M	05/19/2006	Vaccines administered 1/26/06. Exactly seven days later child woke up in night around 11 pm with cough that sounded like he was trying to constantly clear his throat. Awoke next morning with white spots on face and back/body but had red, raised areas on back, but not past the waist. Eyes, nose, and lips were swollen. Taken to ER. Given oral steroid at ER. Mom states she gave him more oral steroid at home as doctor ordered. Complete recovery and no further treatment needed. Mom informed nurse of reaction at 15 month visit on 5/10/2006.				Y					Y	01/26/2006	02/01/2006	6	none	UNK	UNK	none	none	none			1						1	Cough; Eye oedema; Face oedema; Rash erythematous; Rash maculo-papular	FLU3~SANOFI PASTEUR~U1788EA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0620R~3~IM~RL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0301R~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0064R~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0255918	05/19/2006	WA	16.0	16		M	05/19/2006	Administration Menactra at 11:00 AM for trip. Came home, pt's arm pain at school. Didn't feel good. Arm ached and felt achy all over. Went to bed, felt hot and horrible all night long, headache, tossed and turned. Didn't feel like a headache. Could get up. When up /// checked temp 103.5F. Given Tylenol, pushed fluids and temp decreased to 99F. Went up again 10:30 AM to >101F. Left arm is very hard. Doesn't wish to ///. Dizzy and continues to achy.				Y					U	05/18/2006	05/18/2006	0		PUB	PUB	NONE	NONE	NONE			1						1	Dizziness; Flushing; Headache; Injection site induration; Pain; Pruritus; Pyrexia; Sleep disorder; Dizziness; Feeling hot; Headache; Hypokinesia; Injection site pain; Insomnia; Malaise; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1868AAA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2057AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TYP~BERNA BIOTECH, LTD.~3000974~UNK~~~TYPHOID LIVE ORAL TY21A (VIVOTIF)~1|FLU3~SANOFI PASTEUR~U1868AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|MNQ~SANOFI PASTEUR~U2057AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TYP~BERNA BIOTECH, LTD.~3000974~UNK~PO~MO~TYPHOID LIVE ORAL TY21A (VIVOTIF)~2	USA	Emergency room visit	Influenza
0256006	05/22/2006	CA	89.0			M	05/17/2006	Seriousness criteria other medically significant (OMIC). Initial report received on 5/11/2006 from a health care professional. An 89 year old male patient with an unknown medical history, had received an influenza vaccine in the right deltoid on an unspecified day in Sept 2005. the trade name, manufacturer, lot number, and route of administration were not reported. Within a week of receiving the influenza vaccine, the patient developed right shoulder pain and was unable to move his arm. He required medical evaluation, and was treated with steroid injections. Per the reporter the patients influenza vaccination was administered with a 25g one inch needle and may have been administered higher up on the deltoid near the shoulder joint than in the recommended area of the deltoid muscle. At the time of this report, the patient was in rehabilitation and the range of motion in his right arm was improving. The reporter stated that another patient experienced the same reaction following vaccination, but may have only received pneumococcal vaccine. No patient identification or other details were provided for this second patient.				Y					N					OTH	UNK					200601116	1						1	Hypokinesia; Injection site pain; Medication error	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0256025	05/22/2006	MD	51.0	50		M	05/22/2006	11/05 started having speech difficulty. Hoarse speech ever since.				Y					N	10/05/2005	11/01/2005	27	Brain MRI, Myasthaim Gravis panel. Blood test, Carotid artery ultrasound, electroencephalogram, coronary ultrasound, EKG.	OTH	PVT		NONE	NONE			1						1	Dysphonia; Speech disorder	FLU3~SANOFI PASTEUR~U1793AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0257742	05/22/2006	CO	17.0			F	05/18/2006	This case was reported by a physician and described the occurrence of sore arm in a 17 yr old female subject who was inadvertently vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). At the time of administration of Infanrix, the subject was taking Azithromycin for bronchitis. On 25OCt05 the subject inadvertently received a dose of Infanrix in the left arm (dose number and lot number not provided). Infanrix is not recommended for immunizing individuals 7 years of age or older. On 25Oct05, the subject was also vaccinated with influenza virus vaccine (Fluzone). The site of the injection of the Fluzone was not provided. On 25Oct05, less than one day after vaccination with Infanrix and Fluzone the subject experienced a sore arm. At the time of initial reporting, 27Oct05, the sore arm was ongoing.									N	10/25/2005	10/25/2005	0	UNK	PUB	PUB	Azithromycin	Bronchitis	The subject's medical history was not reported.		A0579947A	1						1	Injection site pain	DTAP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0257981	05/22/2006	NY	2.9			F	05/19/2006	Info has been received from an RN concerning an approximately 33 month old female pt who in approximately 2003, was vaccinated in the afternoon with a dose of MMRII. Concomitant vaccine therapy included multiple unknown vaccinations including influenza virus vaccine (unspecified). The physician reported that about 15-18 hours after the vaccinations, the pt had a generalized urticaria. The pt sought unspecified medical attention. The pt recovered. There was no product quality complaint reported. Follow-up info from the physician, indicated that the morning after vaccination in approx. 2003, the pt woke up with generalized facial swelling and hives all over. There was periorbital edema. There was no chest tightness, wheezing, shortness of breath, GI symptoms, nasal symptoms, dizziness or loss of consciousness. The pt's mother gave her Benadryl and the hives went away after several hours. Prior to that, there had been a history of significant diaper rash at about 18 months. Eggs were taken out of the diet and the problem resolved. Therefore, there was a concern of an egg allergy. It was reported that the pt does eat cakes and cookies baked with eggs without any problems. She has eaten Jell-o without any problem. Recently, the pt went for her 2nd follow-up vaccination with MMRII and they refused to give it to her for fear that she would have another reaction. The physician stated that he doubts that the pt's hive reaction was due to the egg content of the flu vaccine. He stated that we will obtain MMR vaccine and do skin testing followed by in office challenge. A skin test will also be done for eggs and if possible for gelatin. It was reported that the pt's father has respiratory allergies. Additional info has been requested.				Y					Y				UNK	OTH	OTH			Diaper rash		WAES0508USA01780	1						1	Swelling face; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|UNK~UNKNOWN MANUFACTURER~~UNK~~~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0256148	05/23/2006	VA	1.28	1	.3	M	05/23/2006	Experieced fever and episodes of global shaking, tightening, and clenching 2 days after his 15 months vaccinations- DTaP, IPV, and MMR. Staring spells; obsessive, non-purposeful play such as spinning; flapping; tip-toe walking; never developed language; lost fine and gross motor skills; inconsolable tantrums and head-banging; lost eye contact and socialization; sensory integration dysfunction; hypotonic; and decreased DTR's.  Diagnosed with Autism otherwise known as Mercury Poisoning. Had 22 vaccinations by 15 months. Requires 40 hours/week of intensive therapy at my expense due to his permanent neurological damage from the vaccinations. 05/25/06-received 2 pages of medical information from clinic-includes vaccine administration record and office visit of 9/23/04, day of vaccine. Documentation includes expressive language delay and referral to language delay program. Spoke with employee at clinic and she will fax additional office notes for visits prior to vaccine administered on 9/23/04, this is the vaccination date that the reporter/mother associates with her child's autistic symptoms.  07/03/06-records from DOS 9/23/04-document expressive language delay. no additional records forthcoming.								Y	N	09/23/2004	09/25/2004	2	Autism Mercury Poisoning	UNK	UNK	None	None	None			1						1	Abnormal behaviour; Autism; Drug toxicity; Hypotonia; Pyrexia; Speech disorder; Staring; Tremor	DTAP~SANOFI PASTEUR~C1699AA~4~IM~RL~DTAP (DAPTACEL)~1|FLUX~UNKNOWN MANUFACTURER~X1038~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0416P~1~IM~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Disabling	Influenza
0256155	05/23/2006	NY	20.0	20		F	02/23/2005	Headache, dizziness, shakiness, heaviness of head.									Y	02/22/2005	02/22/2005	0		UNK	UNK			Sulfa Drugs			1						1	Dizziness; Headache; Tremor	FLU3~SANOFI PASTEUR~U1521AB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0256156	05/23/2006	NY	20.0	20		F	02/23/2005	Dizziness, shakiness, hot flashes, spots in vision.									Y	02/22/2005	02/22/2005	0		OTH	UNK			Suprax			1						1	Dizziness; Hot flush; Tremor; Visual disturbance	FLU3~SANOFI PASTEUR~U1521AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0255918	05/24/2006	WA	16.0	15		M	05/19/2006	Administered Menactra at 11 am at health dept for trip came home from school didn't feel good, arm ached felt achy all over went to bed, felt hot and horrible all night long, headache, tossed and turned. Didn't feel like he could get up, woke up at 7:30 checked temp 103.5 oral gave Tylenol pushed fluids temp went down to 99, spiked again at 10:30am to 101. Left arm is very sore doesn't want to move it. Bed bound, dizzy, continues to achy.									U	05/18/2006	05/18/2006	0		PUB	PUB	NONE	NONE	NONE			1						2	Dizziness; Flushing; Headache; Injection site induration; Pain; Pruritus; Pyrexia; Sleep disorder; Dizziness; Feeling hot; Headache; Hypokinesia; Injection site pain; Insomnia; Malaise; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U1868AAA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2057AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TYP~BERNA BIOTECH, LTD.~3000974~UNK~~~TYPHOID LIVE ORAL TY21A (VIVOTIF)~1|FLU3~SANOFI PASTEUR~U1868AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|MNQ~SANOFI PASTEUR~U2057AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TYP~BERNA BIOTECH, LTD.~3000974~UNK~PO~MO~TYPHOID LIVE ORAL TY21A (VIVOTIF)~2	USA		Influenza
0256341	05/24/2006	FL	15.0	15		M	05/16/2006	Pt twice developed neurologic amyotrophy after influenza vaccine. It occurred in the deltoid region in which he was injected. First episode. Resolved totally. Recovering from 2nd episode. 60 day Follow-up Information 15-AUG-2006: Still in P.T. - not complete strength.				Y				Y	U	11/07/2005	02/01/2006	86	Neuro consult X 2 concurring dx-Parsonage/Turner Syndrome AKA neurologic amyotrophy	PVT	PVT	NONE					1						1	Injection site reaction; Muscle atrophy; Nervous system disorder; Neuralgic amyotrophy	FLU3~SANOFI PASTEUR~U1804AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0256554	05/25/2006		79.0			F		A literature report was received on 02Nov05 concerning a 79 yr old female vaccinee. The vaccinee had a history of abdominal swelling for several months, which was later diagnosed as ovarian carcinoma. No details were provided regarding the vaccinee's  concomitant medications. In Dec 2000, the vaccinee presented with a 2 wk history of purpuric eruption over her lower legs that started 2 weeks after receiving Fluvirin. Investigations revealed elevated ESR at 75mm in the first hr, proteinuria and haematurio on urinalysis. A skin biopsy showed a leucocytoclastic vasculitis which responded to treatment with clobetasol propionate ointment. Her vasculitis had almost fully recovered before anti cancer therapy was started. Her urinalysis returned to normal 2 wks after presentation. The discussion between the authors suggest a causative link could not be proven. Although it it likely that the vaccine has potential to provoke immunologically mediated problems. The mechanism by which influenza vaccine cause vessel damage is likely to be by abnormal immunological activation.														UNK	UNK	NONE	NONE	Several month history of abdominal swelling. Diagnosis of ovarian carcinoma		CVOX200300144	1						1	Haematuria; Proteinuria; Purpura; Vasculitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0256585	05/25/2006	IL	70.0	69		M	05/25/2006	Client began having neurologic symptoms (blurred vision, weakness) week of 11/21/05; tested to rule out stroke, multiple sclerosis; formal diagnosis of Guillan Barre Syndrome made in 1/06; client admitted to hospital for plasmaphorese in 2/06 for three days. Medical records state headache, abnormal gait. msv				Y	Y	3			Y	10/18/2005	11/21/2005	34	Medical records state CSF abnormal, abnormal lab tests. msv	UNK	UNK			Hodgkins Disease (2000); blastomycosis (2004) Discharge summary states hypertension, hyperlipedemia, anemia. msv			1						1	CSF test abnormal; Gait disturbance; Guillain-Barre syndrome; Headache; Laboratory test abnormal; Neurological symptom; Vision blurred; Visual acuity reduced	FLU3~SANOFI PASTEUR~U1838AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0256594	05/25/2006	MN	64.0	64		F	05/24/2006	Phone call from pt today c/o burning sensation right deltoid with vaccine administration 5/3/06. 4 days after (5/7/06) developed a tingling sensation right arm. Use anti inflammatory such as Advil, heat to area, if no improvement to see MD in 3 days.									U	05/03/2006	05/03/2006	0		PUB	PVT	Vivelle dot 0.1, Boniva 1q month	NONE	NONE			1						1	Injection site pain; Paraesthesia; Skin burning sensation	FLU3~SANOFI PASTEUR~U1881AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~194AA~2~IM~LA~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~105AA~2~IM~RA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~Y0535~UNK~SC~LA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0246632	05/26/2006	VT	13.0	13		F	05/23/2006	My daughter's heart stopped during the night after the vaccination took place. It was not related to her diabetes. There was no sign or any seizure. She previously reacted to the pertussis vaccine when she was young. This was her 2nd flu shot.	Y	10/30/2005							N	10/29/2005	10/30/2005	1		PVT	UNK	Lantis; Novolog (Insulin)	Type I Diabetes	Type I Diabetes	~DTP (no brand name)~1~0.00~In Patient		1						2	Cardiac failure; Similar reaction on previous exposure to drug	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Results in Death	Influenza
0255440	05/26/2006	NJ	7.0	7		M	05/24/2006	Initial report received on 5/15/2006 and 5/17/2006 from a physician. A seven year old male patient with no significant past medical history had received an intramuscular dose of Fluzone SV 2005-2006USP, lot number U1753AA, in the deltoid muscle (exact site not reported) on 10/05/2005. Approximately 12 hours post immunization, the patient developed a fever of 101.0 to 103.0 degrees F. He was seen by the physician on 10/8/2005. A strep culture was negative, and the patient was subsequently diagnosed with viral pharyngitis. On 10/12/2005, the patient presented to the physicians office with erythema and swelling of the second through fifth M-P joints on both of his hands. The mother reported that the patient had been bitten by a tick a few days prior to the office visit. Blood work including serology testing was completed for possible lyme disease and all the results were negative. The patient was subsequently diagnosed with acute arthritis. The patients symptoms of fever, viral pharyngitis, erythema and swelling of the second through fifth M-P joints on both hands and acute arthritis were all reported as recovered with a few days of onset of symptoms. On 3/30/2006 the patient developed strep throat and was treated with Amoxil. He had strep throat again on 4/11/2006 and was seen by the physician and treated with Duricef. During the physical examination on 4/11/2006, it was noted the patient had a heart rate of 52. An EKG showed the patient to be in complete heart block. Bradycardia had not been noted on previous examinations and an EKG that was done at birth had shown normal sinus rhythm. The patient was admitted to the hospital from the physicians office and was subsequently transferred to another hospital for placement of a cardiac pacemaker. The patient was subsequently discharged from the hospital and was doing well with the pacemaker on 5/17/2006. His recovery status was reported as not recovered.				Y	Y	7			N	10/05/2005	10/05/2005	0	10/08/2005 strep culture was negative, 10/12/2005 blood work and serology testing to rule out lyme disease was negative. 04/11/2006 EKG showed complete heart block. At an unspecified time, a cardiac pacemaker was placed for complete heart block.	PVT	UNK					200601151	1						2	Arthritis; Atrioventricular block; Bacterial infection; Bradycardia; Cardiac disorder; Erythema; Heart rate irregular; Joint swelling; Pharyngitis; Pharyngolaryngeal pain; Pyrexia; Red blood cell sedimentation rate increased; Viral infection; Arthritis; Atrioventricular block; Bacterial infection; Bradycardia; Erythema; Joint swelling; Pharyngitis; Pharyngolaryngeal pain; Pyrexia; Viral infection	FLU3~SANOFI PASTEUR~U1753AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1753AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0256757	05/26/2006	KS	78.0	77		M	05/26/2006	FOUR HOURS AFTER THE SHOT HAD SOB, FEVER OF 103 DEGREES. DID NOT GO TO THE ER DUE TO THE COST. BETTER THE NEXT DAY. fEVER WENT DOWN. ALL SYMPTOMS GONE BY THE FOLLOWING DAY.									Y	04/24/2006	04/24/2006	0		UNK	UNK	NONE	NO	NO			1						1	Dyspnoea; Pyrexia	FLU3~SANOFI PASTEUR~U1810AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1008P~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U1576BA~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0256968	05/30/2006	MN	10.0	10		F	05/25/2006	1st ever flu shot given 12/16/03 then ITP diagnosed 1/2/04 had noticed easy bruising for about 3-4 wks around the time flu shot given.				Y					Y	12/16/2003	01/02/2004	17	Platelet count 1000 on 1/2/04	PVT	PVT	NONE					1						1	Contusion; Platelet count decreased; Thrombocytopenic purpura	FLU3~EVANS VACCINES~765956~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0257025	05/30/2006	MI	68.0	67		M	05/30/2006	Pt states the day after receiving the Influenza & Pneumococcal vaciines his Rt shoulder started to hurt with stiffness & the pain/stiffness started to progress down into his hips & knees.  He has difficulty opening his Lt hand when he wakes up in the morning.  He states he has a little arthritis in the Lt shoulder & spurs here & there but his physician is not able to find the cause of the joint problems.				Y					N	11/22/2005	11/23/2005	1		UNK	UNK		none	Pt reported joint problems today 5/30/2006.			1						1	Hypokinesia; Joint stiffness; Pain	FLU3~SANOFI PASTEUR~U1930 AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0790P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0257031	05/30/2006	WV	29.0	29		M	05/30/2006	ONE PATCH OF HAIR LOSS APPEARED WITHIN 30 DAYS OF VACCINE ADMINISTRATION AND CONTINUED TO INCREASE OVER THE NEXT COUPLE OF MONTHS. BY TODAY OVER 50 PERCENT OF HEAD AND FACIAL HAIR HAS FALLEN OFF.  VARIOUS STEROID TREATMENT HAVE BEEN ADMINISTERED WITHOUT ANY IMPROVEMENT.									N	10/18/2005	11/15/2005	28	ALOPECIA AREATA	MIL	MIL		ECZEMA	NONE			1						1	Alopecia; Alopecia areata	FLUN3~MEDIMMUNE VACCINES, INC.~500388P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0257819	05/30/2006	SC	40.0			F	05/26/2006	Information has been received from an approx 40 yr old female physician who on 24Oct05 was vaccinated SC with a 0.5ml, second dose of hep A virus vaccine inactivated (lot646790/0693N). Concomitant therapy included influenza virus vaccine (unspecified) and tuberculin purified protein derivative. On 24Oct05 the pt developed blood red eyes, swollen eyes, itchy eyes, swollen tongue and cough approx 1-2 hrs after the dose. She was treated with diphenhydramine hydrochloride (Benadryl) after which a fever developed. As of 28Oct05, she had recovered from the events. Additional information has been requested.				Y					Y	10/24/2005	10/24/2005	0	UNK	OTH	OTH	tuberculin purified protein		UNK		WAES0510USA09900	1						1	Cough; Eye swelling; Ocular hyperaemia; Pruritus; Pyrexia; Tongue oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~MERCK & CO. INC.~0693N~2~SC~~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0257827	05/30/2006		6.0	5		F	05/26/2006	Information has been received from a health professional concerning a 5 yr old female child with no pertinent medical history or allergies who on 20OCT05 was vaccinated with hep A virus vaccine inactivated (lot649459/0287R). Concomitant therapy included influenza virus vaccine (unspecified) (dose not reported). On 20Oct05, 2 hrs after the pt received her first hep A virus vaccine inactivated and flu vaccine in different arms, the pt developed hives. She was treated was diphenhydramine hydrochloride (Benadryl). No lab tests were required. Subsequently about 2 hrs after the vaccine, the pt recovered from hives. Additional information has been requested.				Y					Y	10/20/2005	10/20/2005	0		PVT	OTH	UNK		Immunization		WAES0512USA02799	1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~MERCK & CO. INC.~0287R~UNK~IM~~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0257294	06/01/2006	MD	8.0	8		F	05/11/2006	A report was received of itchy rash coincident to FluMist. An eight year old female received FluMist vaccine sometime between 12/29/2005 and 6/02/2006. In the evening of 1/4/2006, the child developed a rash and was seen by a physician on 1/6/2006. The rash was described as an itchy, erythematous, maculo papular rash primarily located on the upper and lower extremities and the trunk. The child had no fever, cough or congestion and no history of suspicious allergies or similar rash in the past. Physical examination revealed a scattered erythematous fine papular rash on the trunk proximal arms, and the lower extremities. The parents had applied hydrocortisone cream to the rash prior to presentation to the physicians office. Event outcome was not reported. The reporter assessed the causality of the event to FluMist as unrelated.									U	12/29/2005	01/04/2006	6		OTH	OTH	Concomitant drugs not reported				MEDI0004570	1						1	Erythema; Rash maculo-papular; Rash pruritic	FLUN3~MEDIMMUNE VACCINES, INC.~500386P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0257300	06/01/2006	VA	47.0	47		F	05/30/2006	Spouse states 1 day after taking 1st oral typhoid capsule, she developed nausea, headache, abdominal cramps, forgetfulness, disorientation, wheezing. She continued capsules until complete.									U	05/12/2006			NONE	PVT	PVT	Lorazepam, XANAX	NONE	Allergic to Penicillin and Macrolide			1						1	Abdominal pain; Disorientation; Headache; Memory impairment; Nausea; Wheezing	FLU3~SANOFI PASTEUR~U1815AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB106AA~1~IM~RA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~Y1068~UNK~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|TD~MASS. PUB HLTH BIOL LAB~TD152~UNK~IM~LA~TD ADSORBED (TDVAX)~1|TYP~BERNA BIOTECH, LTD.~3000968~1~PO~MO~TYPHOID LIVE ORAL TY21A (VIVOTIF)~1	USA		Influenza
0257347	06/01/2006	TX	38.0	37		F	06/01/2006	PT. DEVELOPED SWELLING AT SITE OF INJ. SOON AFTER ADM. AND STATED FEELING DIZZY. PT. PLACED IN SUPINE POSITION WITH LEGS ELEV. ICE PACK APPLIED TO SITE AND VS TAKEN. B/P 104/68, HR 64, 0XYGEN SATS 100%. AFTER 12 MIN. PT. STATED FEELING BETTER AND WANTING TO SIT UP. ASSISTED TO SITTING POSITION AND VS MONITORED WHILE SITTING BEFORE BEING ALLOWED TO STAND. B/P 113/70, HR 68, 02 100%. NO DIZZINESS STATED, NO SOB NOTED, NO RASH PRESENT. SN AND DR. PRESENT WITH INSTR. TO CALL 911 OR GO TO ER IF SOB, SWELLING OF LIPS, OR WORSENING OF S/S,AND TO CONT. TO USE ICE PACK TO AREA Q 20 MIN ON AND Q20 MIN OFF AS NEEDED.									Y	06/01/2006	06/01/2006	0		PUB	PVT	FLONASE; ZYRTEC; MICROGESTIN					1						1	Dizziness; Injection site swelling	FLU3~SANOFI PASTEUR~U1915AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVA021AA~UNK~IM~RA~HEP A (HAVRIX)~1|IPV~PASTEUR MERIEUX CONNAUGHT~Y1050~UNK~SC~RA~POLIO VIRUS, INACT. (NO BRAND NAME)~1|TTOX~SANOFI PASTEUR~U1703BA~UNK~IM~LA~TETANUS TOXOID, ADSORBED (NO BRAND NAME)~1|TYP~SANOFI PASTEUR~Z0425~UNK~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0257649	06/02/2006	CA	78.0	78		F	11/17/2005	2 days after vaccination, client became ill with s/sx of upset stomach, headache, achy, reddening of skin with a flat rash that appeared to be hives. Symptoms were relieved by Benadryl. Client could not eat for 2 days.									Y	11/07/2005	11/09/2005	2	NONE	PUB	PUB	UNK	NONE	NONE		CA060020	1						1	Erythema; Headache; Oral intake reduced; Pain; Rash; Stomach discomfort	FLU3~SANOFI PASTEUR~U1828AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0257650	06/02/2006	CA	35.0	34		F	11/01/2005	Client did not feel well 1 hour after vaccination, by 21:00 PM. Signs and symptoms included headache, backache, fever 102 F, chills, chest pain and SOB. Client went to ER at 22:30 PM. Received IV fluids and Toradol injection. Client discharged home after about 3 hours. Dx'd at ER-adverse reaction to flu vaccine.				Y					Y	10/28/2005	10/28/2005	0	EKG and CXR to R/O Cardiac problems	PUB	PUB	NONE	NONE	NONE		CA060021	1						1	Back pain; Chest pain; Chills; Dyspnoea; Headache; Hypersensitivity; Malaise; Pyrexia	FLU3~SANOFI PASTEUR~u1828AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0257785	06/05/2006	CO	24.0	24		F	05/25/2006	Took first Vivotif 6/28/05, #2 06/30/05pm, Insomnia, nausea. Dillusional thinking, unaware of surroundings. To hospital ER, diagnosis manic episode, to treatment facility 10 days. Lithium, Zyprexia, Lamictal.					Y	10			Y	06/28/2005	07/01/2005	3		OTH	PVT	NONE					1						1	Abnormal behaviour; Insomnia; Mania; Nausea; Thinking abnormal	FLU3~AVENTIS PASTEUR~U1417AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~AVENTIS PASTEUR~U1211AA~1~IM~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0257936	06/06/2006	TX	42.0	41		F	06/01/2006	Vaccine administered on 10/10/05. On 5/17/06, pt dx'd with influenza via in office flu test. Antibody titer levels drawn on 5/19 show inf type A; Ab <8; inf type B; AB <8, vaccine failed.									Y	10/10/2005	05/17/2006	219	Inf Type A; AB <8; Inf Type B; AB <8	PVT	PVT		NONE	NONE			1						1	Drug ineffective; Influenza like illness; Bronchitis; Influenza like illness; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U1772AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1772A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0251857	06/07/2006	GA	39.0	39		M	06/07/2006	I am still suffering from the symptoms of the vaccines, sick all of the time high blood preasure, dizziness, chills, heat spikes, bad migranes, very tired all of the time.  This medically retired 42 year old reported being in good health prior to his deployment from in 2003.  While there he received his first Anthrax vaccination 16 March 2003 along with his second Hepatitis B vaccination. Later that evening he began to feel hot as if he had a fever and a headache. His headache was a 10/10 pain scale described as a sharp sledge hammer hitting his head to the right side, top, and back of his head. This headache persisted all night causing him to present to sick call the next day where he also complained of profuse sweating.  He was diagnosed with hypertension (records unavailable) and given some pills which did help the headache but did not resolve it. A few days later, approximately 3/21/03 he returned to medical for routine immunizations and was given his primary Smallpox vaccination.  He stated he told medical he was still feeling bad from the AVA/Hepatitis B vaccines and was advised he would get better.  His symptoms worsened that evening and he presented to the emergency room for difficulty breathing, chest pain, feverish and worsening headaches.  He described his chest pain as something sitting on chest better sitting up and as a sharp constricting pain while breathing in or out. He described this pain as unable to take a breathe in as if you were running in zero degree weather.  He was released following a CXR and laboratory studies with an unknown diagnosis of probable reaction to vaccinations. This pain lasted for 2-3 days on an unknown medication.				Y					N	03/16/2003	03/16/2003	0	pending	MIL	MIL	unknown	denies	none			1						2	Arthralgia; Depression; Dizziness; Hypertension; Insomnia; Malaise; Memory impairment; Migraine; Myalgia; Photophobia; Tinnitus; Vomiting; Chest X-ray; Chest discomfort; Chest pain; Chills; Dizziness; Dyspnoea; Fatigue; Feeling hot; Headache; Hypertension; Laboratory test; Migraine; Pyrexia	ANTH~EMERGENT BIOSOLUTIONS~~UNK~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1|ANTH~EMERGENT BIOSOLUTIONS~~1~SC~LA~ANTHRAX (BIOTHRAX)~2|HEP~UNKNOWN MANUFACTURER~~2~SC~~HEP B (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0258182	06/08/2006	UT	4.0	4		M	06/08/2006	Drew up and labled vaccines for patient and sibling.  Patient was reciving 4 immunizations (DTaP, Hepatitis A, Polio, MMR) 2 in each thigh. Gave DTaP, Hepatitis A in the right thigh went to give Polio, MMR immunizations in left thigh and grabbed the immunizations drawn up for the sybling (Hepatitis A, Flu) and administered these instead of the intended vaccines.  Immediately realized what had occurred and informed patient's mother who was present in the exam room.  Patient's mother verbalized understanding of situation and agreement with patient to return at a later date to receive last dose of Polio vaccine as patient had already received 4 injections (one in error) today.  Patient was seen by PCM in Pediatrics NP immediately after leaving Immunization Clinic.  NP reviewed anaphalaxic signs and symptoms and what to watch for and be aware of with patient's mother.									U	06/08/2006	06/08/2006	0		MIL	MIL	unknown	None	none at this time			1						1	Medication error	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B027AA~5~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U1936AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~0287R~3~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0827R~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0258195	06/09/2006	FL	46.0	46		F		A report was received from a consumer on 31May06, concerning a 46 yr old female vaccinee. The vaccinee has a medical history of Graves disease, for which she is being treated with levothyroxine daily. On 04Nov03 the vaccinee received Fluvirin vaccination. Within 24 hrs of the injection she began experiencing severe hot flashes, numbness and tingling, joint pain, night sweats and gait abnormalities. The symptoms have subsided slowly over the past three years, with significant improvement in the last four months, but have not yet completely resolved. The vaccinee was seen by a neurologist soon after the vaccination and serum sickness was diagnosed. Follow up information was received on 19 July 2006 from the subjects Neurologist. Following flu vaccination in November 2003 the vaccines felt generally achy. She noted some whole body paresthesia, muscle aches, fatiguability and a suspicion regarding peripheral neuropathy was raised. The vaccinee denied any history of visual changes, and any family history of multiple sclerosis. The vaccinee has been monitored since March 2003., when she sustained a needlestick injury, and was subsequently found to have a false positive HIV result. Upon examination no neurological deficits were detected, distal and proximal strength and sensation were preserved. Gait and co-ordination were normal. Cranila nerve and mental status examination were unremarkable. Reflexes were symetric at 1/4 throughout including ankle jerks. The general impression was that the whol body paresthesia and pain following vaccination probably represented some immunological derangement similar to that seen in serum sickness and is improving. She did not appear at this time to have any clinical evidence of GUILLIAN-BARRE syndrome, peripheral neuropathy or multiple sclerosis, however an EMG of the lower extremities is to be performed to determine whether or not there is evidence of peripheral neuropathy. Awaiting follow up report from the vaccinees primary physician.									U	11/04/2003	11/05/2003	1		UNK	UNK	SYNTHROID		Graves disease; no risk factors reported; needle stick injury March 2003 - False positive HIV		CVOX200600065	1						1	Arthralgia; Arthralgia; Fatigue; Gait disturbance; Hot flush; Hypoaesthesia; Myalgia; Night sweats; Pain; Paraesthesia; Paraesthesia; Serum sickness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0258294	06/12/2006	CA	1.92	1	.9	M	06/12/2006	Death on 10/26/2005 (found deceased in bedroom), flu vaccination given 10/13/05.  Patient also seen at that time for low-grade fever, crankiness, diarrhea, diagnosed with viral stomatitis given finding of ulcers inside lower lip. 6/20/06 Received medical records from PCP which reveal that on day of vax patient had fever, crankiness, sleep difficulties, diarrhea, decreased oral intake & cold sores of lower lip.  Dx: viral illness & stomatitis.  6/21/06 Received autopsy report which revealed COD as complications of viral infection.  Histology of lungs showed atypical interstitial pneumonitis & brain showed perivascular inflammation consistent with viral infection.  Bacterial & viral cultures were neg.  Neuropath exam revealed focal privascular chronic inflammation consistent with viral encephalopathy./ss	Y	10/26/2005							N	10/13/2005	10/26/2005	13	Final autopsy report just received.  Cause of death complications of viral infection.  All cultures negative.  Pathology of brain showed focal perivascular chronic inflammation consistent with viral encephalopathy, slight brain swelling.  Lung path showed minimal edema and minimal acute and chronic inflammation (mostly lymphocytes and macrophages with occasional neutrophils and rare plasma cells).	UNK	UNK	none	viral stomatitis	none			1						1	Brain oedema; Diarrhoea; Encephalopathy; Irritability; Lip ulceration; Pneumonitis; Pyrexia; Stomatitis; Viral infection	FLU3~SANOFI PASTEUR~U1765CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0258374	06/13/2006	VA	0.5	0	.5	F	06/13/2006	General hives				Y					Y	06/07/2006	06/07/2006	0		PVT	PVT						1						1	Urticaria	DTAP~SANOFI PASTEUR~U432AP~3~~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U867DA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1213R~2~~LL~HEP B (RECOMBIVAX HB)~1|HIBV~SANOFI PASTEUR~UE969AA~3~~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B08651A~3~~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0258442	06/15/2006	GA	49.0	48		F	06/15/2006	Chronic urticaria/Grover's disease which began 2 weeks post influenza vaccine.									N	10/07/2005	10/21/2005	14	TSH, RPR, CBC, ANA, RF--all within normal limits	UNK	UNK	synthroid 0.125mcg, activella 1-.5	none	hypothyroidism			1						1	Urticaria	FLU3~SANOFI PASTEUR~u1777aa~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0258681	06/22/2006	PA	1.02	1	.0	M	06/19/2006	Varicella vaccine breakthrough. Developed fever, cough, nasal congestion on 6/9/06. Temp 100. Rash started 6/14/06. Had about 20 scattered pustules on trunk. Diagnosed with varicella in our office by doctor on 6/14/06.									U	01/12/2004	06/09/2006	879		PVT	PVT	NONE	Otitis media	NONE			1						1	Cough; Nasal congestion; Pyrexia; Rash; Viral infection	FLU3~SANOFI PASTEUR~U1231BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0577N~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0258695	06/22/2006	CA	1.49	1	.5	M	06/22/2006	Complete permanent change of behavior and facial expression.  Brain damage (diagnosed with developmental delays).								Y	N	03/15/2005	03/16/2005	1	diagnosed with developmental delays on 05/23/06	UNK	UNK		Medical record states urinary tract infection. msv	none			1						1	Abnormal behaviour; Nervous system disorder; Neurodevelopmental disorder	FLU3~SANOFI PASTEUR~U1452AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0258725	06/23/2006	OK	44.0	43		M	06/23/2006	June 13, 2006 felt like mass in throat, then numbness in fingers and toes. Started having difficulty in gait followed by weakness in gym (unable to lift weights). Treated by IVIG and dose Prednisolone. Admitted 6/20/06.					Y				U	06/02/2006	06/13/2006	11		PUB	PUB	Ibuprofen; Ambien; Vicodin					1						1	Asthenia; Gait disturbance; Guillain-Barre syndrome; Hypoaesthesia; Movement disorder; Throat tightness; Asthenia; Gait disturbance; Guillain-Barre syndrome; Hypoaesthesia; Throat tightness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~HEP A + HEP B (TWINRIX)~1|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|MNQ~SANOFI PASTEUR~~UNK~~~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|YF~UNKNOWN MANUFACTURER~~UNK~~~YELLOW FEVER (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~HEP A + HEP B (TWINRIX)~2|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~2|MNQ~SANOFI PASTEUR~~UNK~~~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~2|YF~UNKNOWN MANUFACTURER~~UNK~~~YELLOW FEVER (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0258736	06/23/2006	OH	0.21	0	.2	F	06/19/2006	Initial report received on 08May06 from an investigator participating in the above mentioned trial. A six month old female subject experienced failure to thrive and chronic diarrhea, 112 days after receiving an IM, right thigh, second dose injection of Influenza virus vaccine No preservative Trival A and B Subvirion U. Lot number UD07402. Sixteen days later, she was hospitalized for the event. At the time of this report the event was considered ongoing. According to investigator, the events were not related to the study vaccine. Follow up information received on 26May06. The subject's final diagnosis was autoimmune enteropathy assumed to be protein allergy. Follow up information received on 09Jun06. Per the reporter, 105 days post immunization, the subject developed otitis media, chronic diarrhea, mild dehydration and failure to thrive that lead to hospitalization on 06May06. On admission to the hospital the subject weighed 13 pounds 6 oz. A RAST test was completed and was negative for whey, wheat, soybean, peanut and egg. A barium contrast enema of the colon was normal with no abnormalities. Stool cultures for parasite, ova and bacteria were negative. Immunology/serology testing was completed and showed the immunology IGG=875 (range 211-741 mg/dl), IGG 1-750 (range 205-409), IgA 169 (range 10-50), IgM 104 (range 20-100), Celiac disease antibodies showed Gliadin ABS, IgG 74.9 (range 0.0-24.9EU) and Gliadin ABS, IGA34.9 (range 0.0-24.9EU). The HIV antibody was non reactive. Treatment for the event was not provided. The subject was started on Neocate 32-35 oz a day, with no other foods until good weight gain is obtained. The subject was discharged from the hospital on 19May06 with a discharge weight of 12 pounds 10.5 oz. The subject was discontinued from the study on 26May06. At the time of this report, the subject had not recovered from these events. The events in this case were previously reported as not related to the study vaccine, but according to the investigator, the causality has changed and is now being reported as related to the study vaccine.					Y	14			N	12/29/2005	04/20/2006	112		UNK	UNK					200601062	1						1	Dehydration; Diarrhoea; Enteritis; Immunoglobulins increased; Otitis media	DTAP~SANOFI PASTEUR~~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UD07402~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~~3~IM~RL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~~3~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0258740	06/23/2006	CA				U		A nurse reported that a child (gender and age unspecified) with unknown medical history had an episode of seizure following receipt of FluMist vaccine and was hospitalized. Information regarding hospitalization, treatment and event outcome were not provided at the time of this report. The reporter causality was not reported.					Y				U					OTH	OTH	Concomitant drugs not reported				MEDI0004668	1						1	Convulsion	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0258757	06/23/2006	MN	75.0	75		F	02/23/2006	2 weeks after receiving flu shot I started falling and have been in a wheelchair since Feb 2005. Medical records state decreased reflexes, ALS. 60 day Follow-up Information 29-SEP-2006: I am still in a wheel chair. I am gradually regaining strength in my arms and legs and am crawling. I am getting oriental-accupuncture which is helping remove toxins.								Y	N	10/25/2004			Medical records state CK increased, abnormal lab tests. msv	UNK	UNK			Medical records state hyperlipedemia, injury, accident and back pain. msv			1						1	Amyotrophic lateral sclerosis; Balance disorder; Blood creatine phosphokinase increased; Fall; Hyporeflexia; Laboratory test abnormal; Multiple sclerosis; Wheelchair user	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Disabling	Influenza
0258879	06/27/2006	FL	65.0	64		F	06/19/2006	Redness, swelling, fever, knobs under skin. Swelling goes down after aspirin and ice applied. Swelling returns after aspirin wears off. Started 15 days after shot									N	06/14/2006	06/15/2006	1		MIL	MIL		None	None			1						1	Erythema; Rash erythematous; Swelling	FLU3~SANOFI PASTEUR~U1858CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1036P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~AVENTIS PASTEUR~U1707BA~UNK~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0258898	06/27/2006	SC	24.0	24		F	06/27/2006	Had negative pregnancy test on 7APR06 and had subsequent vaccinations on that day. Subsequently had a ligh period on 27APR06 and missed period May/June. Pregnancy test was found to be positive on 15June06. Last sexual activity noted to be 22Mar06 to 6APR06. Estimated due date 1FEB07.									U	04/07/2006	04/07/2006	0	Pregnancy Test 15June06-positive	MIL	MIL	None	None	NKDA			1						1	Medication error; Unintended pregnancy	FLU3~SANOFI PASTEUR~U1916AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~AHBVB190AA~3~IM~RA~HEP B (RECOMBIVAX HB)~1|HEPA~MERCK & CO. INC.~AHAVB066AA~2~IM~RA~HEP A (VAQTA)~1|SMALL~PFIZER\WYETH~4020072~1~ID~LA~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~X0850~1~IM~RA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0258975	06/29/2006	MI	45.0	45		F	06/26/2006	Pt reports that since receiving the flu shot on Mon 10/17, she has developed enlarged lymph nodes on the left side of her neck and into the clavicle area. She has never had a flu shot before. She has had headaches and occasional nausea. She talked to a physician coworker, but did not seek treatment.										10/17/2005	10/17/2005	0		UNK	UNK						1						1	Headache; Lymphadenopathy; Nausea	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0258976	06/29/2006	MI	39.0			U	06/26/2006	Reaction to flu shot - inflamed and spasms in both arms and neck muscles.											12/23/2005			UNK	UNK						1						1	Inflammation; Muscle spasms	FLU3~AVENTIS PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0258977	06/29/2006	MI	37.0			F	06/26/2006	Pt states had flu vaccine a couple of weeks ago and I think I am having a reaction. I have paresthesia. Pt had similar symptoms 5 years ago and was treated by a neurologist who couldn't find anything. Symptoms started morning of 12/28 around 07:00 AM when pt woke up. I am having numbness that starts in my toes and fingers and progresses up my extremities, also having facial numbness. I think it is from the flu vaccine.				Y					U		12/28/2005			OTH	OTH	UNK	UNK	UNK			1						1	Hypoaesthesia	FLU3~AVENTIS PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0258978	06/29/2006	MI	38.0	37		F	06/26/2006	Pt received the flu shot 11/21/05. She experienced chest tightness, but does not think she is wheezing. Also did not have inhaler with her. Asthma exacerbation.				Y					U	11/21/2005	11/21/2005	0		OTH	OTH	Inhaler		Asthma			1						1	Asthma; Chest discomfort	FLU3~AVENTIS PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0259000	06/29/2006	IL	1.17	1	.2	F	06/29/2006	Rec'd. vx for foreign travel on a Friday.  Over the weekend, developed fever followed by rash all over body (sm. red bumps, no vesicles or blisters).  Pediatrician ruled out chickenpox; prescribed Benadryl.				Y					Y	06/09/2006	06/10/2006	1	none done	UNK	UNK	none	none evident	none			1						1	Pyrexia; Rash	FLU3~SANOFI PASTEUR~UI881AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0646R~1~IM~RL~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~0263F~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0259012	06/30/2006	KS	21.0	21		F	06/26/2006	Influenza, PO Typhoid, Tdap given 5/2/06. She developed weakness and shortness of breath that night which continued until 5/3/06. Also mild tachycardia.				Y					Y	05/02/2006	05/02/2006	0	None	OTH	OTH		No	Ceclor, penicillin			1						1	Asthenia; Dyspnoea; Tachycardia	FLU3~SANOFI PASTEUR~U1828AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~(L)C2340AA~UNK~IM~~TDAP (ADACEL)~1|TYP~BERNA BIOTECH, LTD.~3000917~4~PO~MO~TYPHOID LIVE ORAL TY21A (VIVOTIF)~1	USA	Emergency room visit	Influenza
0259055	06/30/2006	CA	50.0	50		F	06/30/2006	Immediate redness, itchiness on vaccination site. As time progresses, redness on site is rising, hard, hot, and increasing in size. Now, at 19 hours post vaccination, arm is aching from wrist to shoulder. As to question 9 - arm has not recovered yet.				Y					U	06/28/2006	06/28/2006	0		UNK	UNK	Synthroid - Generic brand Forteo	none	Allergies to grasses, weeds, trees only.			1						1	Injection site erythema; Injection site hypersensitivity; Injection site induration; Injection site warmth; Pain; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61501~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0259064	06/30/2006	OR	54.0	54		M	06/30/2006	Sore muscles in arm for two weeks.  Soreness increasing from day of shot for weeks.  Muscles throughout body became sore and weak.  Fatique increasingly becoming worse within days of shots and continued to worsen to severe fatigue within 1 week of shots and continues to remain today. Dizziness & nausea within 2 weeks of shots.  Continues off & on regularly.  Mind cloudy and memorory fadding within 1 month of shot.  Continued to worsen and effect daily routine to point of missing work, unable to function as normal causing and to the point of depression.  All symptoms continue now.  Seeing various doctors to treat symptoms.  Various tests and treatment of symptoms continue to date.  Cause possibly due to previous Anthrax Vaccine the effected immune sysmtem and was complicated and compromised health by recent vaccines.  There is a previous Vaers for Anthrax Vaccine on filed in previous years.				Y					N	04/20/2006	04/27/2006	7	blood tests, MRIs,	MIL	MIL		See previous determination of anthrax vaccine VAERS.	Auto immune compromised from previous anthrax vaccine shots from military.  Also old VAERS.			1						1	Condition aggravated; Depression; Dizziness; Fatigue; Muscular weakness; Myalgia; Nausea	FLU3~SANOFI PASTEUR~U1911AA~UNK~PO~MO~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB166AB~UNK~IM~UN~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0259085	07/03/2006		36.0			M	06/28/2006	Information has been received from a health authority concerning a 36 year old male who on 11/10/2005 was vaccinated intramuscularly in the arm with a dose of pneumococcal 23v polysaccharide vaccine (lot #648713/1336N, batch #hv24420). Concomitant suspect therapy given intramuscularly in the same arm included a dose of influenza virus split virion 3v vaccine inactivated (Enzira) (batch #02701). That same day the patient experienced a severe systemic reaction. The patient felt unwell (fatigue) and feverish with a very painful, red, and swollen arm. He also had a headache. The symptoms persisted for five days. At the time of report the patient was recovering. It was noted that the patient had previously received an influenza vaccination without any adverse effects. No further information is available. Other business partner numbers include E200600625 and ADROIT IE002280. The reporter felt that fever, fatigue, pain in arm, swollen arm and headache were other important medical events. (OMIC)									U	11/10/2005	11/10/2005	0		UNK	UNK	UNK				WAES0606USA04777	1						1	Fatigue; Headache; Medication error; Oedema peripheral; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~02701~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1336N~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0252693	07/06/2006	NC	26.0			M	06/30/2006	Initial report received on 26Jun06 from a newspaper article, which was printed in the 24Jun06 edition of the newspaper. A 26 yr old male pt, who was a soldier, received a dose of influenza vaccine and a dose of smallpox vaccine on 18Nov05. The trade names, manufacturers, lot numbers, routes and site of admin were not reported. 16 days after receiving the vaccines, the soldier died. Autopsy tests showed inflammation of the heart muscle. The military physicians who reviewed the pt's case did not find the vaccinia virus, the main ingredient of smallpox vaccine, in the soldier's heart muscle, however they did find evidence of parvovirus B19 and concluded that the vaccines might have caused (the soldier's) death. No other information was available at the time of this report. Follow up information was received from a health care professional on 27Jun06. The smallpox vaccine that was administered was Dryvax. The lot number was not reported, but per the reporter was one lot number for all. The trade name, manf and lot number for the influenza vaccine was not reported. At the time of vaccination, the pt was taking Motrin (one dose from prescription for vaccine side effects) and an alternative medication supplement known as NitroT3, which the reporter states did not appear to contain any active ingredients associated with cardiac effects. The pt had no past medical history of immune problems, anemia, HIV or cancer. He had no history of joint problems. He did have a history of boils on the back as per his mother, but they were never seen by anyone and were not evident at the time of autopsy. The pt presented as dead on arrival and no blood was available for IgM for parvovirus B19. The military is working on obtaining historical sera for serologies. The histology was not consistent with parvovirus B19 and PCR testing will need to be repeated per lab recommendation. The possibility of specimen contamination cannot be ruled out. Additional testing of the liver is planned. As per the reporter, the final autopsy findings was eosinophilic myopericarditis consistent with vaccinia associated myopericarditis.	Y	12/04/2005							N	11/18/2005			Evidence of parvovirus B19 was located in the soldier's heart muscle. The histology was not consistent with parvovirus B19 and PCR testing will need to be repeated per lab recommendation. The possibility of specimen contamination cannot be ruled out. Additional testing of the liver is planned.	UNK	UNK	Motrin, Nitro T3		The pt had no past medical history of immune problems, anemia, HIV or cancer. He had no history of joint problems. He did have a history of boils on the back as per his mother but they were never seen by anyone and were not evident at the time of autopsy.		200601575	1						2	Fatigue; Injection site pain; Laboratory test abnormal; Myocarditis; Pulmonary oedema; Pyrexia; Shoulder pain; Sleep disorder; Sudden death; Cardiac disorder; Eosinophilia; Medication error; Pericarditis; Viral infection	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4020072~1~~LA~SMALLPOX (DRYVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~2	USA	Results in Death	Influenza
0259310	07/07/2006	VA	31.0	31		M	07/07/2006	Heart arrythmia, Syncope, Seizure. Admitted through ED. Stress Test, 3 days telemetry monitoring, Echocardiogram, All normal. 12/12/06 Received medical records from hospital which reveal patient admitted 5/8/06-5/10/06 s/p syncopy & possible seizure following vax.  Patient was incontinent of urine & had post ictal period.  Found to be in atrial fib & was admitted to cardio to r/o MI which was ruled out by enzymes.  Instructed not to receive further anthrax vax. Final Dx: Syncope.			Y	Y	Y	3			Y	05/08/2006	05/08/2006	0	EKG, Cardiac labs, Stress test, Echo, Sonogram R/O DVT LABS: TEE confirmed presence of very small patent foramen ovale.	MIL	MIL		none	Elevated Homo- Systein levels High Cholesterol PMH: hyperlipidemia, electrical shock (requiring skin grafting), increased homocysteine level.			1						1	Arrhythmia; Atrial septal defect; Convulsion; Syncope	ANTH~MICHIGAN DEPT PUB HLTH~~1~IM~LA~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~5~SC~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0259349	07/10/2006	CA	63.0	63		M	07/03/2006	One week after flu shot he developed numbness and tingling of extremities, developed weakness, respiratory failure/diagnosis of Guillain Barre made at another hospital. Pt hospitalized over one year at another hospital and still has residual weakness. Pt has not been back to our facility since Discharge summary states decubitus, apnea, PAT, anemia. msv Discharge summary states contracture, dysphagia, pain, thrombosis. msv. 60 day Follow-up Information 21-SEP-2006: I have had no further contact with patient.					Y			Y	U	10/22/2003	10/29/2003	7	Discharge summary states hyperkalemia. msv	OTH	PUB	UNK		Discharge summary states gout.msv Discharge summary states allergy. msv			1						1	Anaemia; Apnoea; Dysphagia; Guillain-Barre syndrome; Hypoaesthesia; Pain; Respiratory failure; Skin ulcer; Tachycardia paroxysmal; Tendinous contracture; Thrombocythaemia	FLU3~SANOFI PASTEUR~U1287AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0259501	07/13/2006	NJ	54.0	53		F	07/10/2006	Patient feels pain at the injection site, left arm deltoid region, with tenderness to the touch or pressure and weakness of elevation of the left arm. No atrophy. Presented on 05/17/06; improving on Diclofenac 75 mg twice daily.				Y					N	11/01/2005	11/02/2005	1	5/17/06: C K Enzyme 204 N=<165	PVT	PVT	NONE	NONE	NONE			1						1	Blood creatine phosphokinase increased; Injection site pain; Muscular weakness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA151AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0259543	07/13/2006		65.0			F	07/12/2006	The following report was received from another manufacturer. This case was reported by a pharmacist and described the occurrence of anaphylactic reaction in a 65 year old female subject who was vaccinated with influenza virus vaccine live for prophylaxis. Medical conditions included allergy to strawberries, drug reaction/allergy to Demerol, depression and hypertension. On an unspecified date, a number of years ago, the subject received an unspecified dose of Flu vaccine. An unspecified time after vaccine with the Flu vaccine, the subject developed an anaphylactic reaction. The subject sought medical attention. This case was assessed as medically serious (OMIC). At the time of reporting, the event was resolved.									Y					OTH	OTH		Allergies to strawberries, allergy to Demerol, depression and hypertension			A0611876A	1						1	Anaphylactic reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0259568	07/14/2006		22.0	21		F	07/10/2006	In study female subject born on 02Dec1983 was vaccinated with 0.5ml, IM of investigational vaccine (study is still blinded). Per protocol, this 22 yr old female subject was seen at the investigative site for influenza-like illness including fever (102.0F) sore throat, cough, myalgia, and chills. Onset of symptoms was 07Apr06, 157 days after vaccination (vaccination date 01Nov05). Viral culture was positive for influenza B. The investigator considered the event as not related to vaccine. Follow up report pending with resolution date and outcome information. Seriousness criterion: medically significant (OMIC). Possible for vaccine failure. The reported events except for vaccine failure are not expected. On a case level, the case is considered expected due to vaccine failure. Follow up 26Apr06 Complete recovery. Concomitant medications: Trinessa started in 2000 and Zoloft started in 2002. The reported events except for vaccine failure are not expected. On a case level, the case is considered expected due to vaccine failure. Follow up 27Jun06 today we received the information that the study has been unblinded on 26Jun06. The subject received Fluvirin (lot 61122). The reported events except for vaccine failure are not expected. On a case level, the case is considered expected due to vaccine failure.									Y	11/01/2005	04/07/2006	157		OTH	OTH	Trinessa; Zoloft				MA20060271	1						1	Chills; Cough; Drug ineffective; Influenza like illness; Myalgia; Pharyngolaryngeal pain; Pyrexia; Viral infection	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61122~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0259569	07/14/2006		46.0	45		F	07/10/2006	In study a 45 yr old female subject born on 18Mar1960 was vaccinated IM with 0.5ml of investigational drug on 08Nov05. The subject was seen at the investigative site clinic on 03Mar06 for influenza like illness including aching all over, sore throat, fever, cough. Temp taken at the clinic was 100.5F. Onset of symptoms was on 01Mar06, 113 days after immunization. Subject took ibuprofen starting on day of onset (1 March). Rapid influenza test was positive for influenza A. And the subject was given Tamiflu. Viral culture was positive for influenza A/H3N2. Resolution was on 06Mar06 was complete recovery. The investigator considered the event as not related to vaccination. Seriousness criterion: Medically significant (OMIC). Possible for vaccination failure. The reported events, except for vaccination failure, are not expected. On a case level, the case is considered expected due to vaccination failure. Follow up 23Mar06: We just received the completed documentation. No further relevant new information reported. The reported events, except for vaccination failure, are not expected. On a case level, the case is considered expected due to vaccination failure. Follow up 27Jun06: Today we received the information that the study has been unblinded on 26Jun06. Subject received Fluvirin (lot 61122). The reported events, except for vaccination failure, are not expected. On a case level, the case is considered expected due to vaccination failure.									Y	11/08/2005	03/01/2006	113		OTH	OTH	Ibuprofen				MA20060177	1						1	Cough; Drug ineffective; Influenza like illness; Pain; Pharyngolaryngeal pain; Pyrexia; Viral infection	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61122~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0259616	07/17/2006	MI	47.0	47		F	07/17/2006	Received vaccine on a thursday, on Sunday had a reaction after eating (all foods had been previously eaten with no adverse effects). Had severe diarrhea, cramping, facial and throat swelling and passed out. Was eventually transported to hospital via ambulance and diarrhea progressed to bloody diarrhea. Discharge summary states dehydration, hypokalemia. msv				Y	Y	4			Y	10/06/2005	10/09/2005	3	WBCs 13000, PT 13, glucose 107, BUN 20, creatinine 1.0 hemoglobin 15, hematocrit 42.  other test essentially normal.	UNK	UNK	singulair, zyrtec D, prinivil, lasix,tenormin,climara	none Medical records state colitis. msv	asthma, previous surgery for a PDA and also have a replaces aortic valve and an aortic graft Medical records state colitis. msv			1						1	Dehydration; Diarrhoea; Diarrhoea haemorrhagic; Face oedema; Hypokalaemia; Loss of consciousness; Muscle spasms; Pharyngeal oedema; White blood cell count increased	FLU3~SANOFI PASTEUR~u1762aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0259659	07/18/2006	PR		51		M	07/05/2006	NONE										10/12/2002			b	MIL	MIL						1						1	Unevaluable event	ANTH~EMERGENT BIOSOLUTIONS~FAV063~UNK~~~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U0574AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0259663	07/18/2006	OH	1.01	1	.0	M	07/11/2006	Multiple vesicles in various stages of development; rash present for ~6 days. Rash is pruritic. Treatment: atavax syrup 3/4 tsp every 6 hours PRN itching.									Y	12/01/2005	07/11/2006	222		PVT	PUB	None	Upper respiratory infection	SVD			1						1	Blister; Rash pruritic; Rash vesicular	FLU3~SANOFI PASTEUR~I1797DA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE581AA~4~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A56077A~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0550R~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0259671	07/18/2006	OH	0.51	0	.5	F	07/11/2006	After immunizations on 01/12/2006, mom states child was irritable between 4-5 hours after receiving them.  Also states child had breathing difficulties after receiving them later in the evening.  Irritability lasted 3-4 days.  Difficulty breathing only lasted that evening.									Y	01/12/2006	01/12/2006	0		PUB	UNK	NONE	NONE	NONE			1						1	Dyspnoea; Irritability	DTAP~UNKNOWN MANUFACTURER~~UNK~~~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1	USA		Influenza
0259854	07/24/2006	MD	70.0	69		F	07/19/2006	Initial report received on 13Jul06 from another manf who had originally received the report from a healthcare professional. A 69 yr old female pt with a past medical history of allergy to Penicillin (hives), and who had a current work related injury of left leg contusion with probable hematoma, had received an intra muscular dose of Fluzone 2005-2006, lot number U1912AA and a first IM dose of Pneumovax 23, lot number 650649/0790P, on 07Nov05 at 16:30PM. The sites of administration were not reported for either vaccine administered. At 22:00PM, five hours post immunization, the pt developed left upper arm erythema with mild to moderate warmth. Her arm was tender and swollen from the shoulder down with a beefy rash. The pt received unspecified medical attention and was diagnosed with questionable cellulitis. She was treated with Tylenol, antibiotics (Keter), and prednisone. The pt subsequently recovered from these adverse events. Per the reporter, the cellulitis was considered to be an important medical event (OMIC).				Y					Y	11/07/2005	11/07/2005	0		PVT	PVT	Tylenol; Antibiotics (Keter); Prednisone	At the time of vaccination the patient had a work related injury of left leg contusion with probable hematoma.	The patient has a past medical history of allergy to Penicillin that causes hives.		200601773	1						1	Cellulitis; Erythema; Feeling hot; Injection site swelling; Rash; Tenderness; Cellulitis; Injection site erythema; Injection site oedema; Injection site warmth; Rash; Tenderness	FLU3~SANOFI PASTEUR~U1912A~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0790P~1~IM~~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U1912AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0790P~1~IM~UN~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0259860	07/24/2006	OK	11.0	11		F	01/18/2005	Child did not feel well for several weeks before onset. Started fever 12/31/2004. Diagnosed with ear infection 1/3. Progressive weakness and neuro symptoms in legs and arms. Seen in ER 1/8/05 and transported to hospital. Diagnosed with Guillain Barre syndrome. Remains there on a ventilator. Parents report another child with same diag in hospital. Also got flu shot.    11/28/06 Received hospital medical records for 1/8/05-2/1/05  Final DX: GBS; respiratory failure, resolved; bulbar paresis, resolving; and drug induced neutropenia, stable. Records reveal patient developed ascending paralysis & respiratory distress. Intubated from 1/10/05 to 1/25/05.  Also had HTN during hospitlization.  Received plasmapheresis & IVIG x 5 days with slow clinical improvement.  Had neuropathic pain, neutropenia & anemia.  Was transferred to inpatient rehab center.			Y	Y	Y	24	Y		N	11/09/2004	12/31/2004	52	Medical records LABS: LP done 1/08/05 consistent w/GBS. EMG done 1/10/05 revealed acute demyelinating process. ET aspirate & urine c/s both of which grew strep & received antibiotics. Anemia & neutropenia.	PUB	PUB	NONE		Prematurity		OK0501	1						1	Anaemia; Asthenia; CSF test abnormal; Guillain-Barre syndrome; Hypertension; Hypoxia; Malaise; Neutropenia; Otitis media; Paralysis; Pyrexia; Respiratory distress	FLU3~SANOFI PASTEUR~U1527AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0259861	07/24/2006	OK	57.0	57		F	11/15/2004	Dyspnea (Hx of asthma, takes inhaler, oral albuterol, Flovent). Physician diagnosed as RAD. 7/27/06 Received medical records from hospital which reveal patient admitted 11/9/04 on day of vax with chief complaint of SOB, productive cough, chest tightness, HA & leg swelling.  PMH: asthma x 10 years, OA, RA, irregular heart beat, back pain, c-spine fusion, hypothyroidism & gout.  Patient continues to smoke approx 1ppd cigarettes.  Stated that on day of vax did not use her nebs & SOB became progressively worse.  Exam revealed coarse rales & exp wheezing with decreased air movement.  There was 2+ pitting edema of bilateral lower extremities. Dx: acute exacerbation asthma, possible CHF, possible COPD, possible URI, shronic back pain, HTN, irregular heart beat & tobacco abuse.  Progressed well & was d/c home on steroids.  Final dx: acute reactive airway disease/ss					Y	2			Y	11/09/2004	11/09/2004	0	WBC 17.3, UA +.  Chemistries were WNL.	PUB	PUB	Albuterol; Verapamil; Synthroid; Premarin; Lasix; K+ Flovent	RAD	RAD; Heart Disease; HTN		OK0431	1						1	Asthma; Chest discomfort; Cough; Dyspnoea; Headache; Laboratory test abnormal; Rales; Swelling; Wheezing	FLU3~SANOFI PASTEUR~U1530AB~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0259864	07/24/2006	IA	1.0	1	.0	F	07/06/2006	Had 2 hr generalized seizure. Temp 101 ER 107. Subsequently has severe brain damage with loss of speech, walking, vision. Also had abnormal liver enzyme elevation, requiring liver biopsy. Liver recovering. Discharge summary I states cerebral edema, hypotension, hyporeflexive, sepsis. Discharge summary II states edema of arm. msv. 60 day Follow-up Information 11-OCT-2006: Continued severe neurologic sequela unable to talk, walk, feed self (requires gastrostomy), plus findings of cerebral palsey.			Y	Y				Y	N	03/09/2006	03/17/2006	8	AST 11, 475; ALT 8,225; liver Bx severe central necrosis; head MRI diffuse cerebral ischemia.  Discharges summary states elevated BUN, hyponatremia, hypophosphate, anemia. msv	PVT	PVT						1						1	Alanine aminotransferase increased; Anaemia; Aphasia; Aspartate aminotransferase increased; Biopsy liver normal; Blindness; Blood urea increased; Brain oedema; Cerebral ischaemia; Cerebral palsy; Convulsion; Difficulty in walking; Gastrostomy tube insertion; Hepatic enzyme increased; Hepatic necrosis; Hyponatraemia; Hypophosphataemia; Hyporeflexia; Hypotension; Necrosis; Nervous system disorder; Oedema peripheral; Pyrexia; Sepsis; Speech disorder	FLU3~SANOFI PASTEUR~V1866AA~4~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0433R~3~IM~LL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0722R~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08543F~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Life Threatening,Disabling	Influenza
0259868	07/24/2006	OK	52.0	51		F	11/15/2005	States that she did not begin itching or breaking out with hives until the next day. She wasn't sure it was due to flu shot or cleaning chemicals.				Y					Y	11/02/2005				PUB	PUB					OK0558	1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U1805AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0259869	07/24/2006	OK	9.0	9		F	11/09/2005	15:33 Client received Tri-Influenza vaccine 0.5ml administered via R deltoid within 10 min visualized edematous hives localized to face and R posterior arm breathing/respiration regular rate and rhythm, client denied any other symptoms, referred to ER for further eval. B/P 102 64 P 112.				Y					U	11/09/2005	11/09/2005	0		PUB	PUB	4	NONE	NONE		OK0556	1						1	Urticaria	FLU3~SANOFI PASTEUR~U1881AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0259870	07/24/2006	OK		40		F		She presented to the hospital on 11/24/05 c/o sore muscle L deltoid area since receiving Flu shot 8 days ago. Dr's dx muscle or tendon inflammation only.				Y					Y	11/15/2005	11/15/2005	0		PUB	PUB	UNK	NONE	NONE		OK0555	1						1	Injection site inflammation; Injection site pain; Myalgia; Tendon disorder	FLU3~SANOFI PASTEUR~U1881AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0259871	07/24/2006	OK	69.0	69		F	10/17/2005	Malaise, swelling, throbbing to 3 inches below the right elbow, radiating to inner right arm, painful to touch. 10-13-05 started Benadryl and Aleve every 4-6 hours. 10-17-05 swelling and inflammation gone but aching remains. Will continue Aleve. 10-19-05 tenderness only at injection site.									Y	10/12/2005	10/12/2005	0	None	OTH	OTH	Urso, Premarin	No	Shellfish, MSG, alcohol Auto immune liver problem Arthritis			1						1	Inflammation; Malaise; Pain; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U1792AA~3~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0791P~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0259872	07/24/2006	OK		59		F	10/21/2005	Patient describes arm sore after shot, red and swollen later that evening. That night ran fever all over and had joint pain in knees only. Called 10-20-05 use cool pack on arm and Motrin routinely all day. 10-21-05 states much improved, continue Motrin. Today better, red arm only.										10/18/2005	10/18/2005	0		PUB	PUB						1						1	Arthralgia; Erythema; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U1838AA~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0259873	07/24/2006	OK	23.0			F	03/13/2005	State tightness in throat, rash on upper lip and headache times 2 weeks with generalized achiness.									Y				None	PUB	PUB	Toperal	None	None			1						1	Headache; Pain; Rash; Throat tightness	FLUN3~MEDIMMUNE VACCINES, INC.~500340P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TD~UNKNOWN MANUFACTURER~~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0259874	07/24/2006	OK	1.4	1	.4	M	12/16/2004	Mom called. States He got his 1st  half of the flu shot last month at his Dr and he got his 2nd half yesterday from the Health Dept. He started throwing up within an hour of getting the shot. Child doesn't have a rash, fever or diarrhea. Still unable to keep food down. 12-16-04. Instructed mom to call out provider if indicated to watch for signs of dehydration.										12/15/2004	12/15/2004	0	None	PUB	PUB	None	None	None			1						1	Vomiting	FLU3~SANOFI PASTEUR~U1528AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0259875	07/24/2006	OK	14.0	14		F	11/16/2004	Left deltoid became swollen, client states (was heavy) mild rash on arm, face left side. Rash barely visible when presented @ the Grady Co Health Dept 2:00pm 11/16/04									Y	11/15/2004	11/16/2004	1	None	PUB	PUB		None	Asthma			1						1	Rash; Swelling	FLU3~SANOFI PASTEUR~U1460AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0259936	07/24/2006	OK		1	.8	U		Left arm has edema, heat and bruising. Parent's giving TYLENOL.									N	12/09/2004	12/09/2004	0	NONE	PUB	PUB		NONE	NONE		OK0434	1						1	Contusion; Oedema	DTAPH~SANOFI PASTEUR~V08567C~4~IM~LA~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~U1414AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A83578B~3~IM~RA~PNEUMO (PREVNAR)~1	USA		Influenza
0259942	07/24/2006	OK	1.19	1	.2	F	10/18/2004	Client presented to clinic with small pink papules on face, stomach, back, arms. Legs 15-20 total, on 10/15/04. Mom states she started breaking out yesterday. Child scratching bumps. Recommended Calamine lotion, Aveeno bath and Benadryl.									U	11/10/2003	10/14/2004	339	NONE	PUB	PUB	UNK	UNK	UNK		OK0424	1						1	Rash papular; Rash pruritic	FLUX~UNKNOWN MANUFACTURER~U1268AA~1~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~MERCK & CO. INC.~0827N~3~IM~RL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0272N~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~493382~3~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0441N~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0233585	07/25/2006	TX	36.0	36		F	07/21/2006	Information has been received from a registered nurse concerning a 36 year old white female visiting nurse co-worker with a lot of seasonal allergies, who on 12/30/04 in the PM was vaccinated IM with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 647657/0947N). There was no illness at the time of vaccination. Concomitant therapy included a dose of influenza virus whole virion 3v vaccine inactivated. On 1/2/05 in the PM, the patient experienced Guillain-Barre syndrome and was hospitalized. No other information was available regarding the adverse event. It was unknown as to whether the patient recovered. There was no product quality complaint involved. Follow up information received from a nurse indicated that 2-3 days post immunization, the patient reported having an extremely painful and swollen arm at the site of pneumococcal 23v polysaccharide vaccine administration. The physician treated for local cellulitis. The patient continued to feel progressively worse. It was noted that she started with back pain, which, on 1/22/05, progressed to pain and numbness and tingling to the extremities. On 1/27/05, the patient admitted to the hospital because she was unable to stand or walk. Neurogenic bladder was noted. On 2/6/05, an EMG was indicative of Guillain-Barre. She has been admitted to the hospital multiple times since for the symptoms of Guillain-Barre. There was no history of problems with any other vaccination. At the time of the report, the patient was still unable to work, with many cognitive and slurred speech problems. The outcome was reported as not recovered. The reporter indicated that the Guillain-Barre was considered to be disabling, life threatening, and an other important medical event (OMIC). No additional information is expected.			Y	Y	Y	0	Y	Y	N	12/30/2004	01/02/2005	3	Electromyography, 2/06/05: indicative of Guillain-Barre	PVT	PVT			hypersensitivity		WAES0508USA04057	1						3	Abasia; Cellulitis; Guillain-Barre syndrome; Hypoaesthesia; Injection site pain; Injection site reaction; Injection site swelling; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~3|PPV~MERCK & CO. INC.~0947N~1~IM~~PNEUMO (PNEUMOVAX)~3	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0245250	07/25/2006	GA	35.0	34		F	07/21/2006	Initial and follow up information has been received from a pharmacist concerning a 34 yr old female with a depressed immune system and no drug reactions/allergies reported, who on 04Oct05 was vaccinated IM into the left deltoid at 3:00PM with a 0.5ml first dose of pneumococcal 23v polysaccharide vaccine (Lot 650331/0749P) and at the same time vaccinated IM into the right deltoid with a dose of influenzae virus split virion 3v vaccine inactivated (Fluzone). Four hours after the vaccination (7:00PM) on 04Oct05, the pt developed a soreness and swelling in the left arm from the elbow to the shoulder. The pt was seen at the doctor's office. At the time of the report the pt's present status was unk. No product quality complaint was involved. The pharmacist requested a lot check. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. Additional information is not expected.				Y					U	10/04/2005	10/04/2005	0	NONE	OTH	OTH		Total systemic resistance decreased.	UNK		WAES0601USA02738	1						2	Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0749P~1~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0245673	07/25/2006	WA	73.0	73		F	07/21/2006	Information has been received from a health professional concerning a 73 yr old white female who on 06Oct05 at 9:30AM was vaccinated IM in the left arm with a second dose of pneumococcal 23v polysaccharide vaccine (lot650327/0792P). Concomitant vaccination that day included a dose of influenza virus split virion 3v vaccine inactivated (Fluvax) (lot AFLUA1318A) given in the left arm. Four to seven hours post vaccination the pt experienced pain, redness and swelling at the injection site. Unspecified medical attention was sought. At the time of the report the pt had recovered. There was no product quality complaint involved. Follow up information indicated that on 06Oct05 at 19:00 the pt experienced redness, swelling and pain in her left arm. No further information is expected.				Y					Y	10/06/2005	10/06/2005	0	UNK	PVT	OTH			UNK		WAES0510USA07600	1						2	Injection site erythema; Injection site pain; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~1318A~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~2|PPV~MERCK & CO. INC.~0792P~2~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0246068	07/25/2006		76.0	76		M	07/21/2006	Initial and follow-up information has been received from a pharmacist concerning a 76 year old male who on 12-OCT-2005 was vaccinated intramuscularly, with 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot # 651539/0607R). It was reported that this was the first dose of pneumococcal 23v polysaccharide vaccine that the patient had received. On 12-OCT-2005, the patient was also vaccinated intramuscularly in the left arm with 0.5 ml dose of influenza virus vaccine (unspecified). On 13-OCT-2005, the patient went to the doctor's office and was diagnosed with right arm cellulitis. The physician treated the patient with levofloxacin (Levaquin), 750 mg. The patient sought unspecified medical attention. On 19-OCT-2005, the patient had recovered. Upon internal review, the reporter felt that the patient's right arm cellulitis was an other important medical event (OMIC). Additional information has been requested.				Y					Y	10/12/2005	10/13/2005	1		OTH	OTH					WAES0510USA07518	1						2	Cellulitis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0607R~1~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0246352	07/25/2006	OH	67.0	67		F	07/21/2006	Information has been received from a physician concerning a 67 yr old female who on 25Oct05 in the AM was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot650331/0749P), in the right deltoid. Concomitant therapy that day included influenza virus split virion 3v vaccine inactivated (Fluzone (influenza virus split virion 3v vaccine inactivated) ) (lot U1810AA), in the left deltoid. On 26Oct05 the pt experienced severe upper arm edema, erythema, vesicles and itching. Subsequently, the pt recovered. There were no relevant diagnostic tests or lab data. Additional information has been requested.									Y	10/25/2005	10/26/2005	1	NONE	PVT	PVT			UNK		WAES0512USA01472	1						2	Injection site erythema; Injection site oedema; Injection site vesicles; Pruritus	FLU3~SANOFI PASTEUR~U1810AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0749P~UNK~~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0246408	07/25/2006	OH	72.0	71		M	07/21/2006	Edema peripheral; burning sensation; discomfort; urticaria; erythema Information has been received from a registered nurse concerning a 71 year old white male with a penicillin allergy who on 25-OCT-2005 was vaccinated in the right deltoid muscle pneumococcal 23v polysaccharide vaccine (lot #549989/0579P). Concomitant therapy that same day included a vaccination in the left deltoid muscle with influenza virus split virion 3v vaccine inactivated (Fluzone) (influenza virus split virion 3v vaccine inactivated). On 26-OCT-2005 the patient presented at the medical center with a red, swollen hive looking area on the right upper inner arm with complaints of burning and discomfort. The patient's primary care physician prescribed diphenhydramine hydrochloride (Benadryl) which the patient refused. The patient was advised to apply cold packs to the affected area and return for a re-check if the site worsened. The patient's primary care physician also recommended that the patient no longer receive the pneumococcal 23v polysaccharide vaccine. Subsequently, the patient recovered from the red, swollen, hive looking area on the right upper inner arm as well as from the burning and discomfort. Additional information is not expected.				Y					Y	10/25/2005	10/26/2005	1		OTH	OTH			Penicillin allergy		WAES0511USA00535	1						2	Discomfort; Erythema; Oedema peripheral; Skin burning sensation; Swelling; Urticaria; Injection site erythema; Injection site swelling; Skin burning sensation; Urticaria	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~649989/0579P~UNK~IM~~PNEUMO (PNEUMOVAX)~2|PPV~MERCK & CO. INC.~0579P~1~IM~~PNEUMO (PNEUMOVAX)~3	USA	Emergency room visit	Influenza
0246408	07/25/2006	OH	71.0	71		M	07/21/2006	Information has been received from a RN concerning a 71 yr old Caucasian male pt with hypertension and benign prostatic hyperplasia (BPH) who on 25Oct05 at 1:30PM was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot649989/0579P), IM in the right deltoid. There was no illness at the time of vaccination. On 26Oct05 in the PM the pt developed swelling/redness right upper arm, and slight burning sensation began. The pt was seen in the physician's office on 27Oct05. It was also reported that the pt experienced hives and swelling all around injection site. The pt was advised diphenhydramine HC1 (Benadryl) and ice pack. There were no relevant diagnostic tests or laboratory date. The pt recovered on 27Oct05. No further information is expected.				Y					Y	10/25/2005	10/26/2005	1	NONE	PVT	PVT	UNK		Hypertension; Benign prostatic hyperplasia		WAES0511USA00017	1						3	Discomfort; Erythema; Oedema peripheral; Skin burning sensation; Swelling; Urticaria; Injection site erythema; Injection site swelling; Skin burning sensation; Urticaria	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~649989/0579P~UNK~IM~~PNEUMO (PNEUMOVAX)~2|PPV~MERCK & CO. INC.~0579P~1~IM~~PNEUMO (PNEUMOVAX)~3	USA	Emergency room visit	Influenza
0246504	07/25/2006	OH	64.0	64		F	07/21/2006	Information has been received from a RN concerning a 64 yr old Caucasian female with hypothyroid who on 22Oct05 at 11:30AM was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 651318/1006P), in the right arm IM. Concomitant therapy that day included an influenza virus vaccine (unspecified) in the other arm. There was no illness at the time of vaccination. The pt reported that by evening on 22Oct05 at 8:00PM my hand on that arm was puffed out on top and arm was aching. Next day swelling on hand gone down some and knuckles were black and blue. Pain in arm and elbows lasted 4 days. On 6th day the hand (was) still discolored. Information was also received from the responsible physician's office which reported that on 22Oct05 the pt developed edematous to right hand, pain to right arm described as aching. Following day knuckles to right arm ecchymotic, pain lasted 4 days ecchymosis lasted 6 days. The pt recovered one week after immunization. The pt had health dept visit on 26Oct05. No lab tests were performed. It was also reported that other pt's experienced an adverse event following vaccination with pneumococcal 23v polysaccharide vaccine (WAES0510USA09350, 0511USA01105 and 0511USA01106). Additional information is not expected.				Y					Y	10/22/2005	10/22/2005	0	UNK	PUB	PVT			Hypothyroidism	Pain in arm and elbow~Pneumo (no brand name)~~68.00~In Sibling|~Pneumo (no brand name)~~0.00~In Sibling	WAES0511USEA01104	1						2	Arthralgia; Contusion; Ecchymosis; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~1006P~2~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0247439	07/25/2006	OH	64.0	64		M	07/21/2006	Information has been received from a physician concerning a 64 year old male with asparaginase and sulfonamide allergy, hypertension, peptic ulcer disease, gastroesophageal reflux disease, and arteriosclerotic vessel disease who on 11-NOV-2005 AT 8:00 am was vaccinated with pneumococcal 23v polysaccharide vaccine, in the left deltoid.  Concomitant therapy that day included influenza virus split virion 3v vaccine inactivated, in the right deltoid.  Other therapy included amlodipine besylate (NORVASC), alginic acid (+) aluminum hydroxide (+) magnesium carbonate (TOPROL), finasteride(PROSCAR), clopidogrel bisulfate (PLAVIX) and ramipril (ALTACE).  There was no illness at the time vaccination.  On 12-NOV-2005 at 10:45 am the patient experienced external pain in deltoid, trouble abducting arm and redness.  Additional information has been requested.									U	11/11/2005	11/12/2005	1	Unknown	PVT	PVT	TOPAL, NORVASC, PLAVIX, PROSCAR, ALTACE		Concurrent conditions: Sulfonamide allergy, drug hypersensitivity, hypertension, peptic ulcer disease, gastroesophageal reflux disease, atherosclerosis		WAES0512USA01490	1						2	Erythema; Joint range of motion decreased; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA127AB~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~2|PPV~MERCK & CO. INC.~0579P~UNK~~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0249365	07/25/2006	NY	48.0	48		F	07/21/2006	Information has been received from a physician concerning a 48 year old female with hay fever, no egg allergies and no other pertinent medical history had been hospitalized for a possible vascular occlusion of the third finger on her right hand. An angiogram was negative. While in the hospital, on 10/5/05, she was vaccinated in the arm with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant vaccination therapy included a dose of influenza virus split virion 3v vaccine inactivated given in an unspecified but different arm. There were no other concomitant medications. There was no illness at the time of vaccination and the patient was discharged from the hospital on that same day. On 10/10/05, the patient developed a diffused pinpoint rash on her torso that became generalized over her entire body. She went to the hospital emergency room twice on the same day, was treated and released. The first visit, she was treated with oral prednisone and diphenhydramine hydrochloride. The second visit at the ER, she was treated with IV steroids and diphenhydramine hydrochloride, at that time she was placed on prednisone PO. It was noted that the patient experienced a local site reaction of the arm but was unsure if it was site vaccinated with influenza virus vaccine or pneumococcal 23v polysaccharide vaccine. The patient was examined during an office visit on 10/12/05 and the symptoms had resolved. The reporter noted that the patient was not hospitalized for these events. At the time of this report, the patient had recovered. The reporting physician considered the diffuse rash and local site reaction of the arm to be disabling and other important medical events (OMIC). Additional information is not expected.				Y				Y	Y	10/05/2005	10/10/2005	5		PVT	OTH					WAES0510USA06778	1						2	Injection site reaction; Rash	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~2	USA	Disabling	Influenza
0250028	07/25/2006	NE	66.0	66		F	07/21/2006	Information has been received from a licensed practical nurse concerning a 65 year old white female (157 lb) teacher, with no known drug allergies and no medical history, who on 11/09/05 at 3:30 PM was vaccinated IM into the right deltoid with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 651318/1006P). Concomitantly the patient was vaccinated IM into the left deltoid muscle with a fourth dose of influenza split virion 3v vaccine inactivated (lot # U1825EA). Concomitant therapy included rosumvastatin calcium. There was no illness at the time of vaccination. On 11/10/05 the patient developed cellulitis. The patient's right arm was red, warm, painful, and swollen. She had a fever of 102F. The patient was treated with telithromycin 400mg for 9 days and fexofenadine hydrochloride (+) pseudoephedrine hydrochloride 180mg for 10 days. The patient was reported recovered. There was no product quality complaint involved. Follow up information from a health professional indicated that the patient contacted the physician on 11/10/05 and was seen in the office. The patient complained of redness that was raised and demarcated on the leading margin, and tenderness of the right upper arm. The diagnosis was cellulitis of the upper arm. It was noted that the patient was unable to work. The event was considered to be disabling and to be an other important medical event by the reporter (OMIC). The records of testing prior to the release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. A review of the system revealed that there were no open quarantines registered against this lot/fill. Additional information is not expected. This is a consolidation of two reports concerning the same patient.				Y				Y	Y	11/09/2005	11/10/2005	1	Body temp, 11/10/05: 102.	PVT	PVT	CRESTOR				WAES0511USA01987	1						2	Cellulitis; Injection site hypersensitivity; Injection site oedema; Injection site pain; Injection site reaction; Injection site swelling; Injection site warmth; Pyrexia; Tenderness; Cellulitis; Injection site erythema; Injection site reaction; Injection site swelling; Injection site warmth; Pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U1825EA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1006P~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U1825EA~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1006P~1~IM~~PNEUMO (PNEUMOVAX)~2	USA	Disabling	Influenza
0250226	07/25/2006	OH	65.0	65		F	07/21/2006	Information has been received from a 65 year old female public health registered nurse (115 pounds and 5'4) with allergies to phenobarbital, psyllium husk (METAMUCIL) and penicillin who on 10-NOV-2005, at 15:30 was vaccinated SC into the left arm with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine.  On 10-NOV-2005, the patient was vaccinated intramuscular into her left deltoid with a dose of influenza virus vaccine (unspecified).  On 11-NOV-2005, the patient developed swollen axillary glands, difficulty moving her arm, fever and chills for 48 hours, sore arm, pain across her left back and clavicle and down her breast and was extremely tired.  The patient was reported was reported as recovered.  There was no product quality complaint involved.  Additional information is not expected.									Y	11/10/2005	11/11/2005	1	Unknown	PUB	PVT			Concurrent conditions: Penicillin allergy, drug hypersensitivity		WAES0511USA03532	1						2	Erythema; Hypokinesia; Pain; Swelling; Back pain; Chest pain; Chills; Fatigue; Hypokinesia; Lymphadenopathy; Musculoskeletal pain; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U1872AH~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0815P~1~SC~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0815P~UNK~SC~~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0250533	07/25/2006	NE	51.0	51		M	07/21/2006	Information has been received from a healthcare professional concerning a 51 year old male with asthma, thyroid problems, allergic rhinitis, gout and tremor and no allergies who on 31-DEC-2005 in the am was vaccinated, with a second dose of pneumococcal 23v polysaccharide vaccine intramuscularly.  Concomitant therapy that day and time included a first dose of influenza virus split virion 3v vaccine inactivated (FLUZONE), intramuscularly in the arm.  Other concomitant therapy included allopurinol, propranolol HCL (INDERAL), albuterol, fluticasone propionate (FLONASE) and loratadine (CLARTIN).  There was no illness at the time of vaccination.  On 31-dec-2005 the patient had neck stiffness.  On 01-JAN-2006 the patient experienced fever at 101 degrees, some achiness, arm became red, painful, hot hard and swollen (also described as arm inflamed).  The patient recovered on 02-JAN-2006.  There were to relevant diagnostic or laboratory tests.  Additional information is not expected.				Y					Y	12/31/2005	12/31/2005	0	body temperature 01/01/2006 101 F	PVT	PVT	albuterol, allopurinol, FLONASE, CLARITIN, INDERAL		Concurrent conditions: Gout, Asthma, Thyroid disorder, Rhinitis allergic, tremor		WAES0601USA01729	1						2	Feeling hot; Injection site induration; Injection site inflammation; Musculoskeletal stiffness; Pain; Pyrexia; Erythema; Injection site inflammation; Musculoskeletal stiffness; Pain; Pyrexia	FLU3~SANOFI PASTEUR~41761AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1008P~1~IM~UN~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U1761AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1006P~2~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0250739	07/25/2006	OH	12.0	11		M	07/21/2006	Injection site edema; dizziness; medication error; nausea; injection site erythema. Information has been received from a mother who is a licensed practical nurse concerning her 11 year old male son with asthma and allergy to ibuprofen, who on 16-JAN-2006 was vaccinated intramuscularly in the arm with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot#0651254/0605R). Concomitant therapy included influenzae virus vaccine (unspecified) in the same arm. On 16-JAN-2006 several hours post vaccination the patient developed redness near injection site and swelling near injection site and experienced nausea and dizziness. Unspecified medical attention was sought. At the time of the report the symptoms remained. The patient's present status was reported as not recovered. No product quality complaint was involved. additional information has been requested.				Y					N	01/16/2006	01/16/2006	0	None	OTH	OTH			Asthma drug hypersensitivity		WAES0601USA02109	1						2	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth; Pallor; Dizziness; Erythema; Injection site oedema; Medication error; Nausea; Erythema; Feeling hot; Injection site induration; Injection site inflammation; Injection site reaction; Oedema peripheral; Swelling	FLU3~SANOFI PASTEUR~U1753AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1782AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PPV~MERCK & CO. INC.~0605R~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~651524/0605R~UNK~IM~~PNEUMO (PNEUMOVAX)~2|FLU3~SANOFI PASTEUR~U1753AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|MNQ~SANOFI PASTEUR~U1782AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~3|PPV~MERCK & CO. INC.~0605R~1~IM~LA~PNEUMO (PNEUMOVAX)~3	USA	Emergency room visit	Influenza
0251878	07/25/2006	IA	47.0	46		M	07/21/2006	Injection site pain; pain; injection site pruritus; injection site warmth; nausea; malaise; injection site swelling; injection site erythema. Information has been received from a registered nurse concerning a 46 year old white male with penicillin allergy and hypertension who on 02-NOV-2005 at 10:00 AM was vaccinated with pneumococcal 23v polysaccharide vaccine (0.5ml) (IM) (Lot # 649912/529P) in the left deltoid. Concomitant therapy at the same time included influenza virus split virion 3v vaccine inactivated (Fluzone) (influenza virus split virion 3v vaccine inactivated) (IM) (Lot #U1761AA), in the right deltoid. There was no illness at the time of vaccination. On 02-NOV-2006 at 6:00 PM the patient experienced injection site red, itchy, warm to touch, swollen and soreness in the left deltoid. There was a distinct dime where redness and edema stopped. The patient used ice to site. The patient also stated that he had nausea/aching that lasted approximately 12 hours. The patient recovered. There was no adverse experienced following prior vaccinations. Additional information is not expected.				Y					Y	11/02/2005	11/02/2005	0	None	PVT	PUB			Penicillin allergy; hypertension		WAES0511USA00656	1						2	Cellulitis; Erythema; Feeling hot; Nausea; Oedema; Pain; Pruritus; Swelling; Feeling hot; Injection site erythema; Injection site pain; Injection site swelling; Malaise; Nausea; Pain; Pruritus	FLU3~SANOFI PASTEUR~U1761AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0529P~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U1761AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~649912/0529P~UNK~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0259854	07/25/2006	MD	70.0	69		F	07/21/2006	Information has been received from a registered nurse concerning a 69 year old female with a penicillin allergy hives who on 11/7/2005 at 1630 was vaccinated intramuscularly with her first dose of Pneumococcal 23v polysaccharide vaccine (lot 650649/0790P). Concomitant vaccine therapy included a dose of influenza virus split virion 3v vaccine inactivated Fluzone given intramuscularly in the other arm lot U1912AA. At the time of vaccination the patient had a left leg contusion with a probable hematoma (work related). At 2200 that night her left upper arm developed erythema with mild to moderate warmth, was tender and swelled from the shoulder down with a beefy rash. Unspecified medical attention was sought. The patient was diagnosed with questionable cellulitis and was treated with acetaminophen Tylenol ES, antibiotics Keter, 400 two QD x 7 days, and prednisone 20mg, two QD x 5 days, Subsequently, the patient recovered. Cellulitis was considered to be other important medical event (OMIC). No further information is expected.				Y					Y	11/07/2005	11/07/2005	0		PVT	PVT		Contusion of lower leg	Hives, penicillin allergy		WAES0511USA03770	1						2	Cellulitis; Erythema; Feeling hot; Injection site swelling; Rash; Tenderness; Cellulitis; Injection site erythema; Injection site oedema; Injection site warmth; Rash; Tenderness	FLU3~SANOFI PASTEUR~U1912A~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0790P~1~IM~~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U1912AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0790P~1~IM~UN~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0260034	07/25/2006	SC				F	07/21/2006	Information has been received from a respiratory therapist concerning a female age not provided, who on 11/9/05 was vaccinated IM into the left arm with 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). The patient also received influenza virus vaccine unspecified on the opposite arm. On approximately 11/9/05, the patient developed hot, painful and swelling about size of half dollar at injection site. The physician ordered 50mg of diphenhydramine hydrochloride Benadryl PO and 30 mg prednisone for three days. The patient was reported as recovered. Hot, painful and swollen injection site was considered to be an other important medical event by the reporting respiratory therapist (OMIC). There was no product quality complaint involved. Additional information is not expected.									Y	11/09/2005	11/09/2005	0		PVT	PVT					WAES0511USA01974	1						1	Injection site oedema; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0692P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0260038	07/25/2006	SC	49.0	49		F	07/21/2006	Information has been received from a respiratory therapist concerning 49 year old black female educator (164 lb, 66) with no known drug allergies and sarcoidosis who on 07NOV-2005 was vaccinated intramuscularly with 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P).  The patient also received influenza virus vaccine (unspecified) on the opposite arm.  On 07-NOV-2005, the patient developed erythema, hot, itching and swelling about size of half dollar at injection site.  The physician ordered 50 mg by mouth of diphenhydramine hydrochloride (BENADRYL).  The patient was reported as recovered.  hot and swollen injection site was considered to be an other important medical event by the reporting respiratory therapist.  There was no product quality complaint involved.  Additional information is not expected. (considered an other medically important condition) (OMIC)									Y	11/07/2005	11/07/2005	0		PVT	PVT			Concurrent conditions: Sarcoidosis		WAES0511USA02334	1						1	Injection site erythema; Injection site swelling; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0692P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0260039	07/25/2006	NY	37.0	37		M	07/21/2006	Information has been received from a licensed practical nurse concerning a 37 year old white non drinking (also reported to use alcohol regularly, 2-3/day), male, chef, with no known allergies, who lives with his wife, performs his own activities of daily living and is independent, with a past surgical history of an open reduction with an internal fixation of the right lower leg, who has reflux disease, multiple sclerosis for the past two years, inflammatory acne, migraines, joint pain in the pelvic and thigh region, and who formerly had smoked one and a half packs per day since he was fourteen yrs old, and who has a family history of a father with Parkinson's disease, who on 09Nov05 was vaccinated IM into the right arm with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 650453/0791P). Concomitant vaccine administered on the same day included a dose in the left arm of influenza virus vaccine live (unspecified). The nurse reported that the pt self administered interferon beta 1a (Avonex), into the right arm, IM, later in the same day. The nurse stated that the pt had been taking interferon beta la (Avonex), once a week, for about 4 or 6 months (also reported as a year and a half). Concomitant therapy also included lansoprazole (Prevacid) and tetracycline hydrochloride, 500 mg, BID, PO, for the treatment of acne. It was noted that the pt had not had any problems with cellulitis or true injection site reaction in the past. On 09Nov05 the pt developed cellulitis and was hospitalized. The pt had a bacterial culture test which had no problem. The pt was reported as recovered. There was no product quality complaint involved. Follow up information from a physician indicated that on the morning of 09Nov05 the pt felt nauseous with chills, sweating, and fever. The pt experienced a headache and dizziness without hallucinations. It was reported that the pt normally had a feeling of fever and nauseousness the day after his interferon beta 1a (Avonex) shots but this was reportedly much worse than normal. The pt had received the immunization shots before this was reportedly much worse than normal. The pt had received the immunization shots before but never received all three shots in one day before. The pt took naproxen sodium (Aleve) with no relief. The pt's symptoms continued to worsen as the day progressed. The pt then went to the ER where he was started on ceftriaxone sodium (Rocephin) and IV fluids. The pt had presented with a fever of 39 deg C. The pt was treated with acetaminophen (Tylenol), 1g, oral administration. The pt also had three oval shaped areas of warm, erythematous macules over the right deltoid. The pt originally presented with one near the axillary border but upon the examination the pt had two more areas of erythema. The lesions were approx 3cm x 3cm ovals with a larger lesion measuring around 5cm x 3cm. The pt also had a scabbed over burn mark on his right forearm that was clean and dry without any redness or discharge. Upon evaluation, the pt's redness had diminished and was more diffuse compared to the day prior. A review of systems was performed in the hospital on 10Nov05. The review of the head, eyes, ears, nose and throat indicated that the pt had a headache, denied any migraines or head trauma, denied any changes in vision, there was diplopia or loss of visual fields. The review of the ears, nose, and throat indicated that the pt denied any sore throat, congestion or epistaxis. The review of the neck indicated that the pt did not report daily neck stiffness and pain, denied any masses or histories of bruits. The respiratory review indicated that the pt denied any shortness of breath, cough, or hemoptysis. The cardiac review indicated that the pt denied any chest pain, dyspnea on exertion, orthropnea, or palpitations. The gastrointestinal review indicated that the pt reported recent nausea, but denied any vomiting over the past 24 hrs. The genitorinary review indicated that the pt reported weakness and numbness in his hands. His left was greater than his right. The pt did report light headedness, usually after his interferon beta la (Avonex) shots. The musculoskeletal review indicated that the pt reported general arthralgias on a daily basis. The endocrine review indicated that the pt denied any polydipsia, polyphagia, or polyuria. The heme review indicated that the pt denied any ease of bruising, history of deep vein thrombosis, or pulmonary edema. Upon physical examination on 10Nov05 the pt's temp was 98.8, blood pressure was 108/64, pulse was 99, respiratory rate was 18, and O2 saturations were 96% on room air. The pt's extraocular muscles were intact, pupils were equally reactive to light and accommodation, mucosa was pink and moist. The pt's neck was soft, nontender, and no adenopathy was noted. The pt's cardiac examination showed regular rate and rhythm, first heart sound, second heart sound and no murmurs, rubs or gallops. The pt was clear to auscultation bilaterally. There were no wheezes or crackles. The pt's abdomen was soft and non tender with positive bowel sounds at four quadrants. The upper and lower extremity pulses at radial and dorsal pedis were 2+. There were right sided, deltoid, erythematous, macules that were warm to the touch. There was a right forearm burn with signs of good healing. There was no discharge or erythematous base. The assessment was a febrile illness that was secondary to cellulitis, bacteremia was ruled out. The plan was to continue with ceftriaxone sodium (Rocephin), 1g, every 24 hrs, IV. The results of the blood cultures were awaited. Liver function, urinalysis, sedimentation rate, and c reactive protein were cultures were to be checked. The pt was to be observed overnight. A consulting physician indicated that, on 10Nov05, the pt was seen in the ER where he was found to be febrile to 39 and with a white count that was over 20,000. There was a significant cellulitis over the arm and he was admitted for further management. The pt was ultimately admitted on 10Nov05 and started on IV ceftriaxone sodium (Rocephin), 1g, IV, every 12 hrs. The physician noted that despite the IV ceftriaxone sodium (Rocephin) the pt's white count remained high the following day and he remained febrile to 101. It was decided to add some empiric vancomycin 1g IV every 12 hrs. The pt indicated to the physician that over the last day he felt markedly improved. The pt's arm was less tender and his fever was down. His white count was down slightly from 24,000 to 21,000. The review of systems was negative for sore throat, cough, shortness of breath, abdominal pain, diarrhea, dysuria, urgency, frequency, skin rash, or joint symptoms. A physical examination was unremarkable with the exception of a very large area of erythema, warmth and marked tenderness with deep palpation of the muscle area over the right deltoid. The impression was that the pt had a localized cellulitis without abscess formation over his right deltoid area, in the area where he received both the pneumococcal 23v polysaccharide vaccine and interferon beta-1a (Avonex). The physician did not think that this was just a primary injection reaction, and that he may have developed a cellulitis as a result of one of his injections and it was difficult to know whether it was the pneumococcal 23v polysaccharide vaccine or the interferon beta-1a (Avonex). It was reported that the pt seemed to be clinically improving, particularly over the last 24 hrs with vancomycin initiated. The physician indicated that the event may have been a staphylococcal etiology and in particular methicillin resistant Staphylococcus aurous. It was noted that a contaminated needle could not be ruled out. The physician recommended to continue the pt both on vancomycin and ceftriaxone sodium (Rocephin). The pt was to be rechecked to make sure there was no evidence of myositis. A discharge summary from a physician indicated that the pt was discharged on 14Nov05 with a diagnosis of right deltoid cellulitis, resolved leukocytosis, and multiple sclerosis. The discharge medications were linezolid (Zyvox), 600mg, twice a day for the next 10 days, and acetaminophen (+) hydrocodone bitartrate (Vicodin), 1-2 tablets, every 6 hrs, as needed. A physician indicated that the pt presented for a follow up visit on 22Nov05. It was noted that the pt had not worked since 19Nov05 and was planning to return on 24Nov05. It was also noted that the pt had not given himself his usual doses of interferon beta-1a (Avonex). It was reported that the pt had multiple concerns concerning whether to continue with interferon beta 1a (Avonex) and whether to seek the opinion of a sub specially neurologist who works with multiple sclerosis primarily. The assessment for the cellulitis and abscess was that the pt appeared to be significantly improved and his acute syndrome was nearly resolved. The physician noted that he should complete his antibiotic course. The right supraclavicular node would likely remain somewhat tender for the next 1-2 weeks but should resolve without any discomfort. The physician reported that he had sent the vial containing pneumococcal 23v polysaccharide vaccine to the manf for gram stain and culture, in order to identify any possible pathogens which the vaccine might have contained. The physician suspected that the cellulitis was a result of being immunocompromised and probably related to the combination of the two injections given in a short temporal proximity. The physician recommended that the pt wait until 2 weeks had passed since the last dose of antibiotic before restarting interferon beta-1a (Avonex) injections, then continue per routine. It was reported that the pt recovered fully on 22Nov05. Cellulitis was considered to be immediately life threatening, disabling and other important medical event by the reporter (OMIC). A lot check was requested. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. In addition there were no open Quarantines registered against this lot/fill. Additional information is not expected.			Y		Y	0	Y	Y	Y	11/08/2005	11/09/2005	1	Blood pressure 11/10/05 108/6; 11/11/05 120/8; 11/14/05 112/7. Pulse oximetry 11/14/05 71; 11/11/05 80. Chest x-ray 11/09/05 negative for any signs of infiltrates or cardiomegaly. Abscess culture 11/09/05 no problem; arterial blood O2 11/11/05 98%; band neutrophil count 11/10/05 14%; 11/11/05 38%. Segmented neutrophil 11/11/05 48%; body temp 11/10/05 98.8; serum C reactive protein 11/11/05 16; pulse oximetry 11/10/05 96% on room air; hepatic function tests 11/11/05 normal; erythrocyte 11/11/05 4; breath analysis 11/14/05 18; 11/11/05 16; 11/10/05 18; body temp 11/14/05 36.3; 11/11/05 99; hematocrit 11/11/05 39.7; WBC 11/11/05 21.8; WBC 11/09/05 24000; 11/10/05 19.2; total serum carbon 11/10/05 27; total heartbeat count 11/10/05 99; serum sodium 11/10/05 135; serum potassium 11/10/05 135; serum glucose 11/10/05 90; serum creatinine 11/11/05 1.2; 11/10/05 1.1; serum chloride 11/10/05 98; serum blood urea 11/11/05 12; serum blood urea 11/10/05 17; body temp 11/09/05 39C; segmented neutrophil 11/10/05 73; blood culture 11/11/05 no growth; hemoglobin 11/10/05 15.5; platelet count 11/10/05 180; 11/11/05 15600.	PVT	PVT	Avonex; Prevacid; tetracycline hydrochloride 500mg.		Multiple sclerosis; open reduction of fracture with internal fixation. Gastrooesophageal reflux disease; smoker; acne; migraine; arthralgia.		WAES0511USA03361	1						1	Arthralgia; Asthenia; Cellulitis; Chills; Contusion; Dizziness; Headache; Hyperhidrosis; Hypertension; Hypoaesthesia; Injection site erythema; Laboratory test abnormal; Leukocytosis; Medication error; Multiple sclerosis; Nausea; Pyrexia; Rash macular; Skin ulcer; Tenderness; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0791P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0260044	07/25/2006	TN	57.0	56		F	07/21/2006	Information has been received from a health professional concerning a 56 yr old female pt with allergies to codeine derivatives, penicillins and tetracyclines who on 04Nov05 (also reported as 05Dec05) was vaccinated IM in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 650541/1004P) (also reported as 650542/1005P). Concomitant therapy included influenza virus vaccine (unspecified). There was no illness at the time of vaccination. The pt had a local reaction at the injection site on 08Nov05. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information indicated that the pt called the office on 06Dec05 with pain, swelling and rash around injection site which began approx 15:00 on 05Dec05. The pt extended up toward her neck, left ribcage and left breast. On 06Dec05 she still had swelling, rash and pain around the injection site with limited mobility. On 06Dec05, the pt was advised to treat the symptoms with warm compresses and 400-600mg of ibuprofen to decrease inflammation and to help with pain. The pt was further advised to treat with diphenhydramine hydrochloride (Benadryl) (OTC), 25mg or loratadine (Claritin) 1-2 every 6-8 hrs and to call the office if symptoms persisted. At the time of this report, the pt had not called regarding above. The outcome of the events were unk. No further information is available.				Y					U	12/05/2005	12/05/2005	0	UNK	PVT	PVT			Drug hypersensitivity		WAES0512USA00802	1						1	Injection site inflammation; Injection site pain; Injection site rash; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1004P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260046	07/25/2006					U	07/21/2006	Information has been received from a registered pharmacist concerning a patient who was vaccinated with pneumococcal 23v polysaccharide vaccine.  Concomitant therapy that day included influenza virus vaccine (unspecified).  Subsequently the patient experienced cellulitis in the arm that the pneumococcal 23v polysaccharide vaccine was given.  Unspecified medical attention sought.				Y					U				Unknown	OTH	OTH			Unknown		WAES0512USA01233	1						1	Cellulitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260047	07/25/2006	OR	52.0	52		F	07/21/2006	Information has been received from a registered nurse concerning a 52 year old female with exercise induced asthma and allergies to penicillin and sulfonamide who on 11/16/05 at 2:30pm was vaccinated IM, into the left deltoid, with a 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine (lot 651328/1046P). Concomitant therapy included influenza vaccine (lot U1827AA) given IM into the right deltoid. On 11/16/05, shortly after the vaccination, the patient developed redness, warmth, swelling and pain at left deltoid injection site. The patient visited the ER due to the pain but no treatment was required. Follow up reported that the patient sought medical attention via a doctors visit and the patient was treated with unspecified antihistamine and antibiotic. The patient recovered within 2 weeks. The reporting registered nurse considered redness, swelling, warmth and pain at injection site to be other important medical events (OMIC). Additional information is not available.				Y					Y	11/16/2005	11/16/2005	0		OTH	OTH			Asthma exercise induced, Penicillin allergy, Sulfonamide allergy.		WAES0512USA02036	1						1	Injection site hypersensitivity; Injection site oedema; Injection site pain; Injection site reaction; Injection site warmth	FLU3~SANOFI PASTEUR~U18277AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1046P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260051	07/25/2006	MO	52.0	52		F	07/21/2006	Information has been received from a health professional concerning a 52 year old immunocompromised female with rheumatoid arthritis who on 12/08/05 was vaccinated SC in the right arm with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649695/0512P). Concomitant therapy the same day included influenza virus vaccine (unspecified) and tuberculin given in the left arm. On 12/10/05 the patient presented with cellulitis of her right arm. She was treated with antibiotics and has recovered. There was no product quality complaint involved. Cellulitis of right arm was considered to be an other important medical event (OMIC) and disabling. Additional information has been requested.				Y				Y	Y	12/08/2005	12/10/2005	2		OTH	OTH	Tuberculin		Rheumatoid arthritis, Immunosuppression		WAES0512USA03220	1						1	Cellulitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0512P~UNK~SC~UN~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0260076	07/25/2006	PA	76.0	75		F	07/21/2006	Information has been received from a registered nurse concerning a 75 year old female with no known allergies who on 9/14/2005 at 3:30 pm was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine 0.5ml IM lot 647661/0055R, in the right deltoid. Concomitant therapy that day included influenza virus split virion 3v vaccine inactivated lot U1772AA, in the left deltoid. Subsequently within 24 hours, the patient developed an adverse reaction on right arm. The patient experienced redness at injection site, mild swelling and achiness arthralgia. The patient was treated with acetaminophen Tylenol and Ibuprofen. The patient recovered on 9/17/2005. No product quality complaint involved. It was also reported that another patient had an adverse reaction following vaccination with Pneumococcal 23v polysaccharide vaccine (WAES0509USA03027). No further information is expected.				Y					Y	09/14/2005	09/14/2005	0	UNK	PVT	PVT			unk		waes0509usa02437	1						1	Arthralgia; Injection site hypersensitivity; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U1772AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0055R~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260077	07/25/2006	TX	58.0			F	07/21/2006	Information has been received from a physician concerning a 58 yr old female who on 03Oct05 was vaccinated IM with a 0.5mL first dose of pneumococcal 23v polysaccharide vaccine (lot 650327/0792P). Concomitant vaccination on the same day in the other arm included a dose of influenza virus whole virion 3v vaccine inactivated (Fluzone). On 03Oct05, within 1.5 hrs of vaccination, the pt experienced a very sore arm. Unspecified medical attention was sought. No treatment was required. Additional information has been requested.				Y					U	10/03/2005	10/03/2005	0	UNK	OTH	OTH			UNK		WAES0510USA04031	1						1	Injection site pain	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0792P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260078	07/25/2006	VA	86.0	85		F	07/21/2006	Information has been received from a health professional concerning a 86 year old female with asthma, chronic obstructive pulmonary disease, dust allergy, pollen allergy and mold allergy who on 10/11/2005, between 11:00 and 16:00, was vaccinated IM in the right deltoid with a 0.5ml second dose of Pneumococcal 23v polysaccharide vaccine (lot 646501/0497N). Concomitant therapy included a dose in the left arm of influenza vaccine unspecified. On 10/12/2005 the patient presented to the doctor office. She had a knot on the right arm, was feeling funny and had pain in her right arm up to her neck. She was treated with cetirizine hydrochloride Zyrtec and no lab were done. At the time of this report she had not recovered. Follow up information indicated that the patients right arm was swollen down to the elbow, she had pain that ran down her arm and had a strange or funny feeling. There was a knot on her arm where the injection was given. It was reported that the patient recovered on an unknown date. Additional information is not expected.				Y					Y	10/11/2005	10/12/2005	1	NONE	OTH	OTH			Asthma, Chronic obstructive pulmonary disease, house dust allergy, pollen allergy, mycotic allergy.		WAES0510USA06821	1						1	Injection site induration; Injection site oedema; Injection site pain; Malaise; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0479N~2~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260079	07/25/2006	FL	70.0			F	07/21/2006	Information has been received from a 70 year old female with depression, acid reflux, a broken left arm and no allergies who on 10/13/2005, was vaccinated SC in the right arm with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650331/0749P) last dose reportedly received 10 years prior. Concomitant vaccinations on that same day included a dose in the right arm of influenza virus vaccine (unspecified). Other concomitant therapy included esomeprazole magnesium (Nexium), tolterodine tartrate (Detrol) and sertraline HCL Zoloft. The patient reported that on 10/13/2005, she developed chills and swelling and redness around the injection site. No lab diagnostic test were performed as medical attention was not sought. At the time of this report, the patient's events persisted. No further information is available.									N	10/13/2005	10/13/2005	0	NONE	OTH	OTH	Nexium, Zoloft, Detrol		Depression, Acid reflux Oesophageal, arm fracture.		WAES0510USA07463	1						1	Chills; Depression; Injection site hypersensitivity; Injection site oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0749P~2~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0260080	07/25/2006	PA	82.0	82		F	07/21/2006	Information has been received from a pharmacist concerning an 82 yr old white female hospital inpt with a penicillin allergy who on 20Oct05 at 14:30pm was vaccinated IM in the left deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 651524/0605R). Concomitant vaccination at the same time included an IM dose in the right deltoid of influenza virus split virion 3v vaccine inactivated (Fluarix) (lotAFLUA123BC). Concomitant therapy included levothyroxine Na (Synthroid), Mg oxide (Mag ox 400 tablets), excitalopram oxalate (Lexapro). Salcatonin (Miacalcin), sucralfate (Carafate), colestipol HC1 (Colestid), ranitidine hc1 (Zantac), zolpidem tartrate (Ambien), iron (unspecified),  pantoprazole sodium (Protonix), loperamide HC1 (Loperamid), Fluticasone propionate (+) salmeterol xinafoate (Advair diskus), potassium chloride (Klor-con), furosemide (Lasix), ondansetron hydrochloride (Zofran), nitroglycerin (Nitrostat), aluminum hydroxide (+) magnesium hydroxide (Maalox), acetaminophen (Tylenol extra strength), escitalopram oxalate (Lexapro), ferrous sulfate, magnesium hydroxide (Phillips Milk of Magnesia) and lorazepam (Ativan). Illness at the time of vaccination included a rectal bleed, low hemoglobin and hermatocrit, and congestive heart failure. On 21Oct05, the pt developed a local reaction at the injection site on her left arm. She experienced warmth, redness, and a raised area at the injection site. She also had a fever of 102.5 deg F. A chest x-ray and urinalysis were performed (results not provided). Unspecified medical attention was sought. At the time of the report, the pt had not recovered. A product quality complaint was not involved. Follow up information was received from the pharmacist who reported that on 21Oct05 at 8:00AM, the pt had a fever of 102.5 deg, swelling, hardness, redness, tenderness, and warmth at the injection site. The area was noted to be the size of a baseball. The reaction improved daily up until discharge on 25Oct05. The reaction was treated with acetaminophen (Tylenol) 650 mg PO and warm compresses. It was unk if the pt recovered. See lab section for all diagnostic results including a chest x-ray and urinalysis. No further information is expected.				Y					U	10/20/2005	10/21/2005	1	10/21/05: chest x-ray mild CHF; diagnostic lab hep panel: nonreactive; body temp 10/21/05 102.5F; urine acetoacetone negative; urine appearance slightly hazy; urine bacteria screen rare; urine bilirubin test negative; urine blood trace; urine color amber; urine culture <10.0 CFU/M; urine glucose negative; urine leukocyte esterase 2+; urine mucous test none seen; urine nitrite negative; urine pH 6.0 (4.5-7.5); urine protein negative; urine RBC count rare; urine specific gravity 1.015; urine squamous 2-5; urine unspecified casts none seen; urine unspecified none seen; urine urobilinogen 0.2; urine WBC count 20-30.	PUB	PUB	Tylenol extra strength 500mg; Maalox 30 mL; Colestid 5mg; Lexapro 10mg; Ferrous sulfate 325mg; Advair diskus; Lasix (furosemide) 40mg; iron (unspecified); synthroid 75 microgm; Loperamid 2mg; Ativan 2mg; Phillips milk of magnesia 30ml, Mag	Cardiac failure congestive; hematocrit low; haemoglobin low; rectal bleeding	Hospitalization; penicillin allergy		WAES0510USA08417	1						1	Cardiac failure congestive; Feeling hot; Injection site erythema; Injection site induration; Injection site swelling; Pyrexia; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~123BC~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0605R~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260081	07/25/2006	PA				F	07/21/2006	Information has been received from a health professional concerning a female pt who on 21Oct05 was vaccinated IM in the right deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy at the same site in the right deltoid included a dose of influenza virus vaccine (unspecified). On 22Oct05 the pt complained redness and soreness at the site. Unspecified medical attention was sought. The pt is recovering. Follow up information indicated that the pt has recovered. No additional information is available. Additional information is not expected.				Y					Y	10/21/2005	10/22/2005	1	UNK	OTH	OTH	UNK		UNK		WAES0510USA08594	1						1	Injection site erythema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260082	07/25/2006	TX	65.0			M	07/21/2006	Information has been received from a pharmacist concerning a 65 yr old male with an enlarged prostate and a history of benign prostatic hyperplasia who on 17Oct05 was vaccinated with a 0.5mL IM dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). Suspect vaccination that day included a dose of influenza virus vaccine (unspecified). Concomitant therapy included morniflumate (Flomax). The pt complained the same evening that he difficulty voiding. It was reported that the pt had enlargement of the prostate the day after vaccination. Medical attention was not sought. No laboratory diagnostic tests were performed. Subsequently the pt recovered. There was no product quality complaint involved. Additional information is not expected.									Y	10/17/2005	10/17/2005	0	NONE	OTH	OTH	Flomax (Morniflumate)	Enlarged prostate	Benign prostatic hyperplasia		WAES0510USA08741	1						1	Condition aggravated; Dysuria; Prostatic disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0692P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0260083	07/25/2006	CO				F	07/21/2006	Information has been received from a physician concerning a female adult who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included a dose of influenza virus vaccine (unspecified). Subsequently, the pt experienced neck pain. Unspecified medical attention was sought. There was no additional information regarding the pt's present status. No product quality complaint was involved. Additional information has been requested.				Y					U				UNK	OTH	OTH			UNK		WAES0510USA08959	1						1	Neck pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260084	07/25/2006		36.0	36		M	07/21/2006	Information has been received from a RN concerning a 36 yr old male who on 10Oct05 was vaccinated IM with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot650327/0792P). Concomitant therapy included a dose of influenza virus vaccine (unspecified). On 10Oct05 later that day, the pt experienced a severe localized reaction with soreness, redness, and bruising from the deltoid to the elbow, headache and a fever to 101 deg F. It was noted that the pt also experienced 5 minute episodes of nausea, dyspnea and vertigo a few times that evening. Unspecified medical attention was sought. On 12Oct05, the pt recovered. It was also noted that the pt also had a dose of pneumococcal 23v polysaccharide vaccine the year before. No product quality complaint was involved. Additional information has been requested.				Y					Y	10/10/2005	10/10/2005	0	Body temp 10/10/05 101 deg F.	OTH	OTH			UNK		WAES0510USA09233	1						1	Contusion; Dyspnoea; Headache; Injection site erythema; Injection site pain; Nausea; Pyrexia; Vertigo	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0792P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260085	07/25/2006	MT	67.0	66		F	07/21/2006	Information has been received from a licensed practical nurse concerning a 66 yr old female pt with allergies to meperidine hydrochloride (Demerol), codeine, and procaine hydrochloride (Novocain), degenerative joint disease, hormone deficiency and dyspepsia who on 25Oct05 was vaccinated IM into the upper left deltoid with a second dose pneumococcal 23v polysaccharide vaccine (lot 651523/0604R). Concomitant therapy given IM into the left deltoid included a third dose of influenza virus whole virion 3v vaccine inactivated (Fluzone (influenza virus whole virion 3v vaccine inactivated)) (lot U1777AA), Iansoprazole (Prevacid) and omeprazole. There was no illness at the time of vaccination. On 25Oct05, the pt returned to the office because she experienced a more extreme reaction than usual to the vaccine which included possible cellulitis with redness, warmth, swelling at the site and severe site pain and tenderness. Unspecified medical attention was sought. The pt used ice packs and ibuprofen for two days for muscle aches and redness. On 29Oct05 after 4 days, the pt recovered. It was noted that the pt did not have a reaction to the initial vaccination of pneumococcal 23v polysaccharide vaccine. A investigation into the lot number was requested. No product quality complaint was involved. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. Additional information in not expected.				Y					Y	10/25/2005	10/25/2005	0	UNK	OTH	OTH	Prevacid; Prilosec		Drug hypersensitivity; degenerative joint disease; dyspepsia; hormone level abnormal		WAES0510USA09246	1						1	Cellulitis; Feeling hot; Injection site erythema; Injection site pain; Injection site swelling; Myalgia; Tenderness	FLU3~SANOFI PASTEUR~U1777AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0604R~2~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260087	07/25/2006	NY	59.0			M	07/21/2006	Information has been received from a RN concerning a 59 yr old male with neck squamous cell carcinoma, metastases to lung and a history of left upper lobe lobectomy. On 11Oct05 the pt was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649697/1038P). Concomitant suspect therapy included an unspecified influenza virus vaccine. On an unspecified date, the pt complained of a scratchy throat and cough after vaccination. On 14Oct05 the pt was treated for wheezing and a worsening of cough. The pt was ordered sulfamethoxazole (-) trimethoprim (Bactrim), codeine phosphate (+) promethazine hydrochloride (Phenergan with codeine) and an albuterol inhaler. It was reported that the pt was normally dyspneic. Several days later, the physician added fluticasone propionate (+) salmeterol xinafoate (Advair) inhaler. The pt was not getting better and he was started on oral prednisone. On 25Oct05, the nurse contacted the pt and it was reported that he was feeling better. At the time of this report, the pt was recovering from the events. Additional information has been requested.				Y					N	10/11/2005	10/14/2005	3	UNK	OTH	OTH	UNK		Surgery, squamous cell carcinoma; Metastases to lung; dyspnea.		WAES0510USA09450	1						1	Cough; Pharyngolaryngeal pain; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1038P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260088	07/25/2006	NJ	44.0	44		F	07/21/2006	Information has been received from a healthcare worker concerning a 44 yr old female pt with asthma and environmental allergies who on 25Oct05 was vaccinated IM with her first dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). Concomitant therapy included fluticasone propionate (+) salmeterol xinafoate (Advair), tiotropium bromide (Spiriva), montelukast sodium, and albuterol. On 26Oct05 the pt developed redness at injection site (not specified). On 27Oct05 she was seen in the office with blisters around the injection site, with a large red swollen area around that and pain. The pt was treated with diphenhydramine hydrochloride (Benadryl) and another unspecified medication. Her symptoms persisted. No product quality complaint was involved. Follow up information has been received from a physician concerning the female administrative assistant with environmental allergies to trees, grass, dust and ragweed, who on 25Oct05 at 6:00PM was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). On the same day the pt was also vaccinated with influenzae virus split virion 3v vaccine inactivated (Fluzone) in the left deltoid below the pneumococcal 23v polysaccharide vaccination. The physician reported that on the morning of 26Oct05 the pt developed lymphadenitis of the left arm extended to axilla with induration and redness. A complete blood cell count was within normal limits (wnl). The pt recovered from lymphadenitis, induration, and redness. Additional information is not expected.				Y					N	10/25/2005	10/26/2005	1	Complete blood cell 10/2005 wnl	PVT	PVT	Albuterol, Advair, Singulair, Spiriva		Asthma; environmental allergy		WAES0511USA00006	1						1	Injection site erythema; Injection site mass; Injection site pain; Injection site swelling; Injection site vesicles; Lymphadenitis	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0529P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260092	07/25/2006	PA				U	07/21/2006	Incision site cellulitis; pain; vomiting Information has been received from a registered nurse concerning a patient in their 60's who in approximately October 2005 was vaccinated intramuscularly with a 0.5ml of pneumococcal 23v polysaccharide vaccine. Concomitant vaccination at the same time included influenza virus vaccine (unspecified) (both vaccines were administered at separate sites and via separate syringes). Subsequently the patient developed a site reaction of cellulitis, vomiting and described their body as hurting. Unspecified medical attention was sought. The patient was treated and subsequently recovered. Additional information has been requested.				Y					Y				Unknown	OTH	OTH			Unknown		WAES0511USA00186	1						1	Cellulitis; Pain; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260094	07/25/2006	ID				M	07/21/2006	Information has been received from a physician concerning a male who on 02-NOV-2005 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine.  Concomitant therapy that day in the sane arm included influenza virus vaccine (unspecified).  The first vaccination was given three months ago and second was given by mistake. On 02-NOV-2005 the patient experienced pain at the injection site.  Follow up reported that the patient did not have reaction  Additional information has been requested.				Y					U	11/02/2005	11/02/2005	0	Unknown	OTH	OTH			Unknown		WAES0511USA00499	1						1	Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~2~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260096	07/25/2006	FL				U	07/21/2006	Information has been received from a physician concerning an adult patient who within the lst week (approximately November 2005) was vaccinated SC with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine. Concomitant vaccine therapy administered on the same day included a dose of influenza virus vaccine (unspecified). The physician reported that within the last week (approximately November 2005) the patient developed redness only, at the injection site. It was mentioned that the patient may have been given a steroid. It was also mentioned that the nurse gave both shots in the same arm but no record could be found. There were no laboratory studies performed. The adverse event improved and the patient is recovering. There was no product quality event reported. No further information was available regarding the adverse event. The patient sought unspecified medical attention. Additional information has been requested.				Y					N				None	OTH	OTH			Unknown		WAES0511USA00941	1						1	Erythema; Injection site erythema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~SC~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260097	07/25/2006	NY				F	07/21/2006	Information has been received from a female consumer who on 23-OCT-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot reported as 1406P.  Concomitant therapy that day in the same arm included influenza virus vaccine (unspecified).  She reported that she became quite ill beginning the day after receiving the shots, on 24-OCT-2005.  The patient's physician confirmed that she experienced a severe reaction to the vaccination.  The patient ended up missing a full week of work and at the time of the report was still feeling the effects.  No further information was provided.  No product quality complaint was involved.  Additional information has been requested.									N	10/23/2005	10/24/2005	1	Unknown	OTH	OTH			Unknown		WAES0511USA01194	1						1	Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0260098	07/25/2006	NC	68.0	68		F	07/21/2006	Initial and follow up information has been received from a health professional concerning a 68 year old white female, with hypertension, hypercholesterolemia, penicillin allergy, venous insufficiency and peripheral vascular disorder who on 08-NOV-2005 was vaccinated intramuscularly in the left deltoid with a second dose  (0.5 ml) of pneumococcal 23v polysaccharide vaccine (lot 651329/1047P) and at the same time was vaccinated intramuscularly in the right deltoid with a second dose of influenza virus SAg 3v vaccine inactivated (CHIRON). On 08-NOV-2005 the patient's left deltoid area became red, swollen, warm to touch and sore.  The patient was notified to use warm compresses and call back if no better.  Subsequently, on an unknown date, the patient recovered.  No product quality complaint was involved.  Additional information is not expected.				Y					Y	11/08/2005	11/08/2005	0	NONE	PVT	PVT			Concurrent conditions: hypertension, hypercholesterolemia, penicillin allergy, venous insufficiency, peripheral vascular disorder		WAES0511USA01531	1						1	Erythema; Feeling hot; Myalgia; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1047P~2~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260099	07/25/2006	TN	74.0	74		F	07/21/2006	Information has been received from a health professional concerning a 74 year old female with allergies to acetaminophen (+) hydrocodone bitartrate (LORTAB) and acetaminophen (+) codeine phosphate (TYLENOL 3) who on 26-OCT-2005 was vaccinated intramuscular in the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine.  Concomitant vaccines that day included the influenza vaccine (unspecified).  There was no illness at the time of vaccination.  On 26-OCT-2005 she had a severe local reaction on the right arm at or near the injection site of the pneumococcal 23v polysaccharide vaccine.  She had discomfort, bruising, inflammation and redness.  The outcome was unknown. Unspecified medial attention was sought.  No product quality complaint was involved.  Follow up information indicated that the patient returned to the office on 28-OCT-2005, she had felt arm discomfort on that day of injection.  Over the next 2 days, beginning on 28-OCT-2005, the patient had bruising and inflammation to the site and the surrounding area was red and hot with swelling.  No laboratory tests are performed and the patient recovered on 31-OCT-2005.  Additional information is not expected.				Y					Y	10/26/2005	10/26/2005	0	NONE	PVT	PVT			Concurrent conditions: drug hypersensitivity		WAES0511USA01805	1						1	Contusion; Discomfort; Erythema; Injection site inflammation; Injection site reaction; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0531P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260100	07/25/2006	NC	74.0	74		M	07/21/2006	Follow up information has been received from a licensed practical nurse concerning a 74 year old male patient, with hypertension, hyperlipidemia, erectile dysfunction (ED), and unknown drug reactions/allergies who on 08-NOV-2005 was vaccinated intramuscularly in the left deltoid with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine.  It was also reported that the patient received a second dose of influenza virus vaccine (AVENTIS) intramuscularly in the right deltoid on the same day.  The patient stated about 1 hour after she got home, on 08-NOV-2005, 'the area became red swollen, hot to touch.  There was no illness at the time of vaccination.  It was reported that the patient either presented to the office or called the office to report the adverse events.  The treatment was a warm compress and follow up call to the physician if needed.  Outcome was reported as unknown.  No product quality complaint was involved.  Additional information is not expected.				Y					U	11/08/2005	11/30/2005	22	Unknown	PVT	PVT			Concurrent conditions: Hypertension, Hyperlipidemia, Erectile dysfunction		WAES0511USA02024	1						1	Erythema; Swelling	FLU3~SANOFI PASTEUR~~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1047P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260101	07/25/2006	CT	3.0			M	07/21/2006	Information has been received from a registered nurse concerning a 3 year old male with asthma who on 08-nov-2005 was vaccinated subcutaneous in right arm with a dose of pneumococcal 23v polysaccharide vaccine.  The patient was given a flu shot (unspecified) in the same arm as pneumococcal 23v polysaccharide vaccine.  On 08-nov-2005, 6 hours after the vaccination, the patient developed a cellulitis reaction, 103 F fever, erythema and pain.  The pain was reported as recovered.  There was no product quality complaint involved.  A lot check has been requested.  The records of testing prior to release of this lot have been checked and found to be satisfactory.  The lot complies with the standard and revealed that there were no open quarantines registered against this lot/fill.  Additional informational has been requested.									Y	11/08/2005	11/08/2005	0	body temperature 11/08/2005  103 degrees	OTH	OTH			Concurrent conditions: asthma		WAES0511USA02160	1						1	Cellulitis; Erythema; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0792P~UNK~SC~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0260102	07/25/2006	PA				U	07/21/2006	Information has been received from a registered nurse concerning a patient in approximately October 2005, was vaccinated intramuscularly with 0.5 ml of pneumococcal 23v polysaccharide vaccine.  Concomitant vaccination at the same time included influenza virus vaccine (unspecified)(both vaccines were administered at separate sites and via separate syringes).  Subsequently the patient developed an injection site reaction.  The arm was red and swollen and was described as being cellulitis like, however the patient was not diagnosed with cellulitis .  Unspecified ,medical attention was sought.  The patient was treated and the reaction went down the next day.  Additional information has been requested.				Y					Y				Unknown	OTH	OTH			Unknown		WAES0511USA02410	1						1	Erythema; Injection site reaction; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260103	07/25/2006	PA				U	07/21/2006	Information has been received from a registered nurse concerning a patient who in approximately October 2005, was vaccinated intramuscularly with 0.5 ml of pneumococcal 23v polysaccharide vaccine.  Concomitant vaccination at the same time included influenza virus vaccine (unspecified) (both vaccines were administered at separate sites and via separate syringes).  Subsequently the patient developed an injection site reaction.  No further details pertaining to the site reaction were available.  Unspecified medical attention was sought.  The patient subsequently recovered.  Additional information has been requested.				Y					Y				Unknown	OTH	OTH			Unknown		WAES0511USA02424	1						1	Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260104	07/25/2006	MO	44.0	44		F	07/21/2006	Information has been received from a certified medical assistant (CMA) concerning a patient who was vaccinated with pneumococcal 23v polysaccharide vaccine.  Subsequently the patient experienced swelling, pain at injection site and hot skin to touch.  The outcome of the events was not reported.  In follow up, the certified medical assistant reported that this patient had not developed hotness of swelling as originally reported.  The 44 year old female with diabetes mellitus, an allergy to codeine and hypercholesterolemia was vaccinated in the right arm on 07-NOV-2005 with a dose of pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included influenza virus vaccine (unspecified), also given in the right arm the same day and tetanus toxoid, given in the left arm on the same day.  On 08-NOV-2005 the patient's right arm ached through to breast and chest.  There was no redness.  The patient's outcome was not reported.  No further information is available.									U	11/07/2005	11/08/2005	1	Unknown	PVT	OTH			Concurrent conditions: drug hypersensitivity, diabetes mellitus, hypercholesterolemia		WAES0611USA02487	1						1	Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0751P~UNK~~~PNEUMO (PNEUMOVAX)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0260105	07/25/2006	MO	65.0	65		M	07/21/2006	Information has been received from a certified medical assistant (CMA) concerning a 65 year old patient who on 28-OCT-2005 was vaccinated with pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included tetanus toxoid and influenza virus vaccine (unspecified).  Subsequently the patient experienced swelling, pain at injection site, hot skin to touch, red and warm to touch at injection site, and achiness all over.  The outcome of the events was not reported.  Follow up information has been received concerning the 65 year old male patient employed in a dental lab with coronary artery disease (CAD), diabetes mellitus, hypertension, and a history of myocardial infarction (2002) who on 28-OCT-2005 was vaccinated in the right arm with a dose of pneumococcal 23v polysaccharide vaccine.  On the same day, the patient was also vaccinated in the right arm with influenza virus vaccine (unspecified), and in the left arm with tetanus toxoid.  Other concomitant therapy included pioglotazone hydrochloride (ACTOS). atorvastatin calcium (LIPITOR), aspirin, metoprolol, lisinopril, and glipizide.  On 29-OCT-2005 it was reported that the patient developed red, hot and swollen at injection site.  The patient recovered.  Additional information is not expected.									Y	10/28/2005	10/29/2005	1	Unknown	PVT	OTH	aspirin, LIPITOR, glipizide, lisinopril, metoprolol, ACTOS		Medical History: myocardial infarction Concurrent conditions: coronary artery disease, diabetes mellitus, hypertension		WAES0511USA02488	1						1	Injection site inflammation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0751P~UNK~~~PNEUMO (PNEUMOVAX)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~~TETANUS TOXOID, ADSORBED (NO BRAND NAME)~1	USA		Influenza
0260106	07/25/2006	MO	70.0	70		F	07/21/2006	Information has been received from a certified medical assistant (CMA) concerning a 70 year old patient who on 28-OCT-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient experienced pain at injection site, hot skin to touch, swelling, achiness all over, and red and warm to touch at injection site.  The outcome of the events was not reported.  Follow up information has been received from a physician concerning the 70 year old female restaurant owner with hypertension, diabetes mellitus, hypothyroidism, anemia and allergies to clarithromycin (BIAXIN) and codeine who on 28-OCT-2005 was vaccinated in the right arm with her second dose (first dose in 2000) of pneumococcal 23v polysaccharide vaccine. lot number ( confirmed certified medical assistant stated when patient's chart was pulled the lot number was not the lot originally reported).  The patient was vaccinated with influenza virus vaccine in the left arm on the same day.  On 28-OCT-2005 the patient developed right arm red, hot swollen, hard lump, feels flu like symptoms.  The patient required unspecified oral antibiotics and recovered on approximately 30-NOV-2005.  Additional information is not expected.									Y	10/28/2005	10/28/2005	0	Unknown	PVT	OTH			Medical History: Immunization Concurrent conditions: allergic reaction to antibiotics, drug hypersensitivity, hypertension, hypothyroidism, diabetes mellitus, anemia		WAES0511USA02489	1						1	Influenza like illness; Injection site erythema; Injection site pain; Injection site swelling; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0751P~2~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0260107	07/25/2006	FL	59.0	58		F	07/21/2006	Information has been received from a 58 year old female with hypothyroidism an allergy to sulfa, who on 31-OCT-2005 was vaccinated subcutaneous in the right arm with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine.  Concomitant vaccine therapy administered on 31-OCT-2005 included a dose of influenza virus vaccine (unspecified) administered in the left arm.  Other concomitant medication included levothyroxine Na (SYNTHROID).  The patient reported that the next day, on 01-NOV-2005 she experienced a severe reaction and reported that her right upper arm swelled, was hot, red, filled with fluid, and was about 40 percent than normal.  She also experienced a fever and chills and reported that  I was in bed for a couple of days.  The adverse events improved and she recovered on 08-NOV-2005.  There was no product quality complaint reported.  The patient did not seek medical attention.  Additional information has been requested.									Y	10/31/2005	11/01/2005	1	NONE	OTH	OTH	SYNTHROID		Concurrent conditions: hypothyroidism, Sulfonamide allergy		WAES0511USA03092	1						1	Chills; Hypersensitivity; Injection site inflammation; Pyrexia; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~SC~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0260108	07/25/2006	NE	52.0	52		F	07/21/2006	Information has been received from a license practical nurse concerning a 52 year old female daycare provider with sulfa allergy and no medical history, who on 09-NOV-2005, at 16:45, was vaccinated intramuscular into the right deltoid with a first 0.5 ml dose of pneumococcal 23v polysaccharide vaccine.  On 09-NOV-2005, the patient was vaccinated intramuscular with a third dose of influenza virus split virion 3v vaccine inactivated (FLUZONE). Concomitant therapy included levothyroxine Na (LEVOXYL).  There was no illness at the time of vaccination.  On 11-NOV-2005 the patient developed cellulitis, fever and body aches.  The patient's arm was swollen and redeemed.  The patient was treated with cephalexin (KEFLEX) 500 mg four times a day for 10 days, gatifloxacia (TEQUIN) 400 mg every day for 5 days and ceftriaxone sodium sodium (ROCEPHIN) 500 mg every day for 3 days.  The patient was reported as recovered.  Follow up information from a health professional indicted that the patient was seen on 11-NOV-2005 by a physician and complained of a red, raised, swollen area at the injection site that spread to the axilla.  It was noted that the patient said she had run a fever, but her temperature was normal in the physician's office.  The diagnosis was cellulitis and an abscess of the upper arm.  The patient was seen again on 12-NOV-2005 and received another injection of ceftriaxone sodium (ROCEPHIN), and the arm area looked improved.  The patient had not been seen since.  There was no product quality complaint involved.  Additional information is not expected.  This report is a consolidation of two reports concerning the same patient.									Y	11/09/2005	11/10/2005	1	body temperature 11/17?/2005  fever	PVT	PVT	LEVOXYL		Concurrent conditions: Sulfonamide allergy		WAES0511USA03464	1						1	Cellulitis; Erythema; Injection site swelling; Pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U1825EA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1006P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0260109	07/25/2006	VA	74.0	73		M	07/21/2006	Edema peripheral; fatigue; pain; erythema Information has been received from a physician and a registered nurse concerning a 73 year old retired white male with no allergies or medical history who on 31-OCT-2005 was vaccinated IM in the left deltoid with a second 0.5ml dose of pneumococcal 23v polysaccharide vaccine (Lot #649914/0578F). Concomitant therapy included psyllium husk (Metamucil), aspirin daily, Vitamin B12 injection monthly, and a dose of influenza virus vaccine (unspecified) given in the right arm. There was no illness at the time of vaccination. A few hours post vaccination, the patient developed fatigue. At 2200 that night he developed an onset of redness and swelling in the left arm from his shoulder to his elbow and total body aches. Unspecified medical attention was sought. No lab studies were performed. Twelve hours later he felt completely fine. On 21-NOV-2005 he notified the office. It was also reported that in 1997 the patient had received a first dose of pneumococcal 23v polysaccharide vaccine. No product quality complaint was involved. No further information is expected.				Y					Y	10/31/2005	10/31/2005	0	None	OTH	OTH	aspirin cyanocobalamin Metamucil		None		WAES0511USA03535	1						1	Erythema; Fatigue; Oedema peripheral; Pain; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~649914/0578P~2~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260110	07/25/2006	MT	61.0	60		F	07/21/2006	Injection site pain; Swelling Initial and follow up information has been received from a licensed practical nurse concerning a 60 year old white female with arrhythmia. hormone replacement therapy, no known allergies an a prior immunization with pneumococcal 23v polysaccharide vaccine in 2000. On 26-OCT-2005, the patient was vaccinated intramuscularly into the left arm with pneumococcal 23v polysaccharide vaccine (Lot #651526/0604R). On that same day in the AM the patient was vaccinated intramuscularly into the right arm with the fourth dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (influenza virus split virion 3v vaccine inactivated) (Lot #U1777AA). Concomitant therapy included verapamil, estrogens, conjugated (Premarin) and digoxin (Lanoxin). On 26-OCT-2005 in the PM the patient developed extremely painful muscle at the injection site and some swelling x4days. On 30-OCT-2005 the patient recovered from the events. Additional information is not expected.									Y	10/26/2005	10/26/2005	0	Unknown	PVT	PVT	Lanoxin Premarin verapamil		Arrhythmia, hormone replacement therapy		WAES0511USA03736	1						1	Injection site pain; Swelling	FLU3~SANOFI PASTEUR~U1777AA~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~651523/0604R~2~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0260111	07/25/2006	MT	62.0	62		F	07/21/2006	Injection Site Pain Information has been received from a health professional concerning a 62 year old white retired female with hyperparathyroidism and no known allergies who on the morning of 27-OCT2005 was vaccinated IM into the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot #651523/0604R). Concomitant therapy given IM in the morning into right deltoid included a dose of influenza virus whole virion 3v vaccine inactivated (Fluzone) (influenza virus whole virion3v vaccine inactivated( (lot #U1777AA), calcium carbonate (+) cholecalciferol (Caltrate + D) and vitamins (unspecified) On 31-OCT-2005 the patient recovered. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.									Y	10/27/2005	10/27/2005	0	Unknown	OTH	OTH	Caltrate + D Vitamins (unspecified)		hyperparathyroidism		WAES0511USA03742	1						1	Injection site pain	FLU3~SANOFI PASTEUR~U1777AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~651523/0604R~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0260112	07/25/2006					U	07/21/2006	Swelling Information has been received from a nurse concerning a patient who on an unspecified date was vaccinated IM in the arm with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included an unspecified influenza virus vaccine given in the same arm. Subsequently, the patient developed swelling. Medical attention was sought. Subsequently, the patient recovered. No further information is available.				Y					Y				Unknown	OTH	OTH			Unknown		WAES0511USA03756	1						1	Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260113	07/25/2006	MO	18.0	17		M	07/21/2006	Injection site reaction; pain; erythema; skim warm; swelling. Information has been received from a licensed practical nurse concerning a 17 year old (also reported as 14 year old) white male with diabetes mellitus juvenile onset who on 07-NOV-2005 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine in the left deltoid (650649/0790P), intramuscularly in the left deltoid. Concomitant therapy that day included a first dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (Batch #U1792AA) intramuscularly in the right deltoid. The patient experienced a local injection site reaction after receiving pneumococcal 23v polysaccharide vaccine, described as swollen, red warmth and pain to left deltoid. The patient was told to use ice 2 to 3 times an hour and ibuprofen (Advil) and diphenhydramine hydrochloride (Benadryl). The patient recovered on 11-NOV-2005. There was no illness at the time of vaccination. The patient did not experience any adverse events following prior vaccinations. The records testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. In addition, a review of the Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill. Additional information not expected.				Y					Y	11/07/2005	11/08/2005	1	None	PVT	OTH			Diabetes mellitus juvenile onset		WAES0511USA03776	1						1	Erythema; Feeling hot; Injection site pain; Swelling	FLU3~SANOFI PASTEUR~U1792AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~650649/0790P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260114	07/25/2006	PA	61.0			M	07/21/2006	Injection site reaction; chills; myalgia Information has been received from a physician concerning a 61 year old male with diabetes who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy three days prior to the pneumococcal 23v polysaccharide vaccine included a dose of influenza virus vaccine (unspecified). Subsequently the patient experienced a severe injection site reaction with chills and myalgia. It was noted that the patient recovered on an unknown date. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.				Y					Y				Unknown	OTH	OTH			Diabetes		WAES0511USA03799	1						1	Chills; Injection site reaction; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260115	07/25/2006	MT	61.0			F	07/21/2006	Erythema; pain in extremity; edema; peripheral Information has been received from a health professional concerning a 61 year old white female with degenerative joint disease, hormone deficient, hyperparathyroidism, codeine and sodium pent allergy who on 25-OCT-2005 later in the PM was vaccinated IM in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (Lot #651523/0604R). Concomitant therapy included a IM dose in the left deltoid of influenza virus split virion 3v vaccine inactivated (Fluzone) (influenza virus split virion 3v vaccine inactivated) (Lot U1777AA). It was reported that the patient had 2+ doses of influenza virus split virion 3v vaccine inactivated (Fluzone) (influenza virus split virion 3v vaccine inactivated). On 25-OCT-2005 the patient complained of a red, painful and swollen arm after the immunization. It was reported that it lasted two days and the patient recovered.  Additional information is not expected.									Y	10/25/2005	10/25/2005	0	Unknown	PVT	PVT			Degenerative joint disease; hormonal imbalance; drug hypersensitivity; hyperparathyroidism		WAES0511USA03869	1						1	Erythema; Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~U1777AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~651523/0604R~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0260116	07/25/2006	CT	8.0			F	07/21/2006	Pyrexia; erythema Information has been received from a registered nurse concerning a 8 year old female with asthma who in late October 2005 was vaccinated SQ in right arm with a dose of pneumococcal 23v polysaccharide vaccine (lot #not provided). The patient was given a flu shot (unspecified) in the same arm as pneumococcal 23v polysaccharide vaccine. Twelve hours post vaccination the patient developed a 103 F fever and erythema. The fever persisted for 12 hours. The patient was reported as recovered. There was no product quality complaint involved. Additional information has been requested.									Y				body temp 10/??/05 103 degree	OTH	OTH			Asthma		WAES0511USA04331	1						1	Erythema; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~SC~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0260117	07/25/2006	MT	53.0	53		F	07/21/2006	Pain in extremity; erythema; edema peripheral Information has been received from a licensed practical nurse concerning a 53 year old white female with a tetanus allergy and clindamycin allergy, who on 25-OCT-2005 was vaccinated IM into the right arm with a fifth dose of pneumococcal 23v polysaccharide vaccine (lot #651526/0604R). Concomitant therapy given IM into the left arm included a second dose of influenza virus whole virion 3v vaccine inactivated (Fluzone) (influenza virus whole virion 3v vaccine inactivated (lot #U1777AA) montelukast sodium (MSD) calcium (unspecified) (+) vitamins (unspecified) and temazepam (Restoril). There was no illness at the time of vaccination. On the evening of 25-OCT-2005 the patient's upper arm became extremely painful, red and swollen. The patient's arm remained painful and swollen for 4 to 5 days. Unspecified medical attention was sought. The patient was treated with ibuprofen and acetaminophen (Tylenol) for the discomfort. It was noted that the patient started to feed better after 7 days. On 01-NOV-2005 the patient recovered. An investigation into the lot number was requested. No product quality complaint was involved. The records of testing prior to release of this lot have been check by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.				Y					Y	10/25/2005	10/25/2005	0	Unknown	OTH	OTH	Calcium (unspecified) Singulair Restoril		Allergy to vaccine Drug hypersensitivity		WAES0511USA04616	1						1	Erythema; Oedema peripheral; Pain; Swelling	FLU3~SANOFI PASTEUR~U1777AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~651523/0604R~5~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260118	07/25/2006	WA	19.0	18		M	07/21/2006	Injection site pain; injection site erythema Information has been received from a registered nurse concerning an 18 year old male with asthma who on 01-DEC-2005 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (Lot #651318/1006P). Concomitant therapy given into the other arm included a dose of influenza virus vaccine (unspecified) (no reaction noted). On 01-DEC-2005 (previously report as 04-DEC-2005) the patient was seen in the doctor's office with an injection site reaction described as pain and redness. No diagnostic laboratory studies were performed. The patient was treated with cephalexin (Keflex). Four days later, the patient's symptoms completely resolved. No product quality complaint was involved. Additional information is not expected.				Y					Y	12/01/2005	12/01/2005	0	None	PVT	OTH			Asthma		WAES0512USA01724	1						1	Erythema; Injection site erythema; Injection site pain; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~651318/1006P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260119	07/25/2006		86.0	86		F	07/21/2006	Information has been received from a pharmacist concerning an 86 yr old female inpt with a diagnosis of cardiac arrhythmia who on 10Dec05 was vaccinated IM in the arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 651572/0741R) as a routine immunization during hospital stay. Concomitant therapy included warfarin sodium (Coumadin), atorvastatin calcium (Lipitor), isosorbide mononitrate (IMDUR), tolterodine tartrate (Detrol LA), diltiazem hydrochloride (Cardizem CD), and an unspecified influenza virus vaccine (given the same day, in the other arm). Later on 10Dec05, the pt developed a red raised area at the pneumococcal 23v polysaccharide vaccine injection site. The pt reported that the area was sore to the touch. On 12Dec05, the area of redness had increased to approx 4 by 6 inches in size. Tylenol was ordered for discomfort but had not been taken. Cold compresses had been used. At the time of the report, the pt had not recovered. Additional information has been requested.									N	12/10/2005	12/10/2005	0	UNK	OTH	OTH	Lipitor, Cardizem CD, IMDUR, Detrol LA, Coumadin		Arrythmia; hospitalization		WAES0512USA01911	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0741R~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0260120	07/25/2006	WA	58.0	58		M	07/21/2006	Information has been received from a RN concerning an 58 yr old male with asthma who on 05Dec05 was vaccinated IM into the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 650330/0748P). Concomitant therapy given into the other arm included a dose of influenza virus vaccine (unspecified) (no reaction noted). That night, the pt experienced an injection site reaction described as pain with tenderness, swelling and redness. On 06Dec05, the pt was seen in the doctor's office. The pt was treated with cephalexin (Keflex). Two days later, the pt's symptoms completely resolved. No product quality complaint was involved. Additional information is not expected.				Y					Y	12/05/2005	12/05/2005	0	NONE	PVT	OTH			Asthma		WAES0512USA01913	1						1	Injection site erythema; Injection site pain; Injection site swelling; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0748P~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260121	07/25/2006	MN				M	07/21/2006	Information has been received from a medical assistant via a company rep concerning a male physician who on approx 19Nov05 was vaccinated IM into the arm with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine. Concomitant vaccination at the same time in the same arm included a dose of influenza virus vaccine (unspecified). Subsequently, on approx 19Nov05, the pt was very ill for two days and experienced body aches, fever and severe site reaction involving a rash, soreness and swelling down his entire arm. Unspecified medical attention was sought. The physician was reported to have recovered. There was no product quality complaint involved. Additional information has been requested.				Y					Y	11/19/2005	11/19/2005	0	UNK	OTH	OTH	UNK		UNK		WAES0512USA02801	1						1	Injection site pain; Injection site rash; Injection site swelling; Malaise; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260122	07/25/2006	TN	72.0			M	07/21/2006	Information has been received from a RN concerning a 72 yr old male who on 23Nov05 was vaccinated IM in the arm with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot unspecified). Secondary suspect vaccinations included a dose of influenza virus vaccine (unspecified) given in the same arm as the pneumococcal 23v polysaccharide vaccine. On 23Nov05 the pt developed swelling and itching at the injection site. Unspecified medical attention was sought and the pt was given over the counter medications to calm his symptoms and he recovered (date unspecified). No product quality complaint was involved. Additional information has been requested.				Y					Y	11/23/2005	11/23/2005	0	UNK	OTH	OTH	UNK		UNK		WAES0512USA03808	1						1	Injection site swelling; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260123	07/25/2006	MO	55.0			F	07/21/2006	Information has been received from a physician concerning a 55 yr old white retired female with no allergies who in approx Oct 2005, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot not reported). Concomitant suspect therapy included a dose of influenza virus vaccine (unspecified) administered at the same time into the same arm. On 26Oct05 the pt developed redness from the shoulder to elbow, swollen tender, axilla glands, and throbbing pain. It was reported that the pt stated that she received the pneumococcal 23v polysaccharide vaccine yearly for 10 yrs except last year. The pt outcome was not reported. Additional information has been requested.									U		10/26/2005		UNK	OTH	OTH	UNK		Immunization		WAES0601USA00893	1						1	Injection site erythema; Lymphadenopathy; Pain; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0260124	07/25/2006	GA	68.0	68		M	07/21/2006	Initial and follow up information has been received from a pharmacist concerning a 68 yr old white male with shellfish allergy who on 03Oct05 was vaccinated at 5:30PM IM into the left deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 650331/0749P) and at the same time vaccinated IM into the right deltoid with a dose of influenza virus split virion 3v vaccine inactivated (Fluzone). Concomitant therapy included clopidogrel bisulfate (Plavix), ramipril (Altace) and rosuvastatin calcium (Crestor). There was no illness at the time of vaccination. At 7:00PM on 03Oct05 the pt complained of itching on the back of the neck and woke up at night with swollen, red left arm from the elbow to the shoulder. The pt was seen at the doctor's office and treated with ibuprofen, 800mg 3x/day and ice. At the time of the report the pt's present status was unk. No product quality complaint was involved. Pharmacists is requesting a lot check.  The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. Additional information is not expected.				Y					U	10/03/2005	10/03/2005	0	Body temp 98.8 deg	OTH	PUB	Plavix, Altace, Crestor		Shellfish allergy		WAES0601USA02753	1						1	Injection site erythema; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260125	07/25/2006	CA				M	07/21/2006	Information has been received from a RN concerning a male pt (18 to 20 yrs of age) who on 25Jan06 was vaccinated SC in the left tricep with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P). Concomitant therapy included influenza virus 3v reassortant vaccine live intranasal (Flumist), hep A virus vaccine inactivated (+) hep B virus vaccine rHBsAg (yeast) (Twinrix), meningococcal ACYW conj vaccine (dip toxoid) (Menactra), MMR vaccine, penicillin G benazathine (Bicillin) and tuberculin purified protein derivative. In less than 24 hrs, on approx 26Jan06 the pt experienced localized cellulitis like reactions, soreness from the tricep to axilla, redness, limited range of motion, hardness at injection site. The pt had a fever of 101. 6 deg F and had a CBC lab test performed. It was noted that in the past no reactions had been noted when the pt received the vaccine IM in the deltoid. Unspecified medical attention was sought. The outcome was reported as unk. No product quality complaint was involved. Additional information has been requested.				Y					U	01/25/2006	01/26/2006	1	1/26/06 body temp 101.6; CBC no results provided.	OTH	OTH			UNK		WAES0602USA00231	1						1	Cellulitis; Injection site erythema; Injection site induration; Injection site pain; Movement disorder; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~HEP A + HEP B (TWINRIX)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|MNQ~SANOFI PASTEUR~~UNK~~~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PPV~MERCK & CO. INC.~0490P~UNK~SC~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260126	07/25/2006					U	07/21/2006	Information has been received from a RN pharmacist concerning a pt who was vaccinated with pneumococcal 23v polysaccharide vaccine. Concomitant therapy that day included influenza virus vaccine (unspecified). Subsequently the pt experienced cellulitis in the arm that the pneumococcal 23v polysaccharide vaccine was given. Unspecified medical attention was sought.				Y					U				UNK	OTH	OTH			UNK		WAES0604USA00284	1						1	Cellulitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260420	07/25/2006	FL				M	07/21/2006	Information has been received from a physician concerning a male who on 10/12/05 was vaccinated with Pneumococcal 23v polysaccharide vaccine (0.5ml), in the arm. Concomitant therapy that day included influenza virus vaccine (unspecified), in the opposite arm. On 10/14/05 the pts arm was swollen (arm vaccinated with Pneumococcal 23v polysaccharide vaccine). The physician did not think that the Pneumococcal 23v polysaccharide vaccine caused the swelling. The pt was prescribed an antibiotic and swelling was gone. Subsequently, the pt recovered. Additional information has been requested.				Y					Y	10/12/2005	10/14/2005	2	UNK	OTH	OTH			UNK		WAES0511USA01529	1						1	Injection site oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0260439	07/25/2006	OH				U	07/21/2006	Information has been received from a physician a pt who in Oct/Nov05, who along with 6 other pt's was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 650331/0749P and 649989/0579P). Some pt's were first time vaccinated while others received a previous injection at least 5 yrs ago. Concomitantly they were vaccinated in separate sites with a dose of influenza virus vaccine (unspecified). Subsequently, the pt developed severe local reactions. The pt was reported as recovered. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. In addition, a review of the quality control system revealed that there were no open quarantines registered against this lot/fill. There was no product quality complaint involved. Additional information has been requested.									Y				UNK	OTH	OTH			UNK		WAES0511USA02164	1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0749P~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0260753	07/25/2006	OH				U	07/21/2006	Information has been received from a physician regarding a patient who, along with 6 other patients, in October/November 2005, was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot# 650331/0749P and 649989/0579P). Some patients were first time vaccinated while others received a previous injection at least 5 years ago. Concomitantly they were vaccinated in separate sites with a dose of influenza virus vaccine  (unspecified). Subsequently, the patient developed severe local reactions.  The patient was reported as recovered.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. In additional, a review of the Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill. There was no product quality complaint involved. Additional information ahs been requested.									Y	10/01/2005	10/01/2005	0	UNK	OTH	OTH			UNK		WAES0606USA03884	1						1	Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0579P~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0260754	07/25/2006	OH				U	07/21/2006	Information has been received from a physician regarding a patient who, along with 6 other patients, in October/November 2005, was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot# 650331/0749P and 649989/0579P). Some patients were first time vaccinated while others received a previous injection at least 5 years ago. Concomitantly they were vaccinated in separate sites with a dose of influenza virus vaccine  (unspecified). Subsequently, the patient developed severe local reactions.  The patient was reported as recovered.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. In additional, a review of the Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill. There was no product quality complaint involved. Additional information ahs been requested.									Y	10/01/2005	10/01/2005	0	UNK	OTH	OTH			UNK		WAES0606USA03885	1						1	Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0579P~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0260755	07/25/2006	OH				U	07/21/2006	Information has been received from a physician regarding a patient who, along with 6 other patients, in October/November 2005, was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot# 650331/0749P and 649989/0579P). Some patients were first time vaccinated while others received a previous injection at least 5 years ago. Concomitantly they were vaccinated in separate sites with a dose of influenza virus vaccine  (unspecified). Subsequently, the patient developed severe local reactions.  The patient was reported as recovered.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. In additional, a review of the Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill. There was no product quality complaint involved. Additional information ahs been requested.									Y	10/01/2005	10/01/2005	0	UNK	OTH	OTH			UNK		WAES0606USA03886	1						1	Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0579P~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0260756	07/25/2006	OH				U	07/21/2006	Information has been received from a physician regarding a patient who, along with 6 other patients, in October/November 2005, was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot# 650331/0749P and 649989/0579P). Some patients were first time vaccinated while others received a previous injection at least 5 years ago. Concomitantly they were vaccinated in separate sites with a dose of influenza virus vaccine  (unspecified). Subsequently, the patient developed severe local reactions.  The patient was reported as recovered.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. In additional, a review of the Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill. There was no product quality complaint involved. Additional information ahs been requested.									Y	10/01/2005	10/01/2005	0	UNK	OTH	OTH			UNK		WAES0606USA03887	1						1	Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0579P~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0260757	07/25/2006	OH				U	07/21/2006	Information has been received from a physician regarding a patient who, along with 6 other patients, in October/November 2005, was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot# 650331/0749P and 649989/0579P). Some patients were first time vaccinated while others received a previous injection at least 5 years ago. Concomitantly they were vaccinated in separate sites with a dose of influenza virus vaccine  (unspecified). Subsequently, the patient developed severe local reactions.  The patient was reported as recovered.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. In additional, a review of the Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill. There was no product quality complaint involved. Additional information ahs been requested.									Y	10/01/2005	10/01/2005	0	UNK	OTH	OTH			UNK		WAES0606USA03888	1						1	Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0579P~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0260758	07/25/2006	OH				U	07/21/2006	Information has been received from a physician regarding a patient who, along with 6 other patients, in October/November 2005, was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot# 650331/0749P and 649989/0579P). Some patients were first time vaccinated while others received a previous injection at least 5 years ago. Concomitantly they were vaccinated in separate sites with a dose of influenza virus vaccine  (unspecified). Subsequently, the patient developed severe local reactions.  The patient was reported as recovered.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. In additional, a review of the Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill. There was no product quality complaint involved. Additional information ahs been requested.									Y	10/01/2005	10/01/2005	0	UNK	OTH	OTH			UNK		WAES0606USA03889	1						1	Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0579P~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0260279	07/26/2006	TX	8.0	8		F	07/21/2006	Approximately 1 month after receiving hepatitis A child developed vitiligo followed by autoimmune Thyroiditis with complete thyroid failure.										10/24/2005	11/04/2005	11		PVT	PVT						1						1	Thyroid disorder; Thyroiditis; Vitiligo	FLU3~SANOFI PASTEUR~U1756AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0400R~1~IM~RA~HEP A (VAQTA)~1	USA		Influenza
0260280	07/26/2006	MA	71.0	70		F	07/20/2006	Severe pain at injection site (right deltoid) started 2 days post injection, radiated down arm to dorsa medial metacarpal area and into back of neck.  Pain has persisted up to this time (patient told me about this, first time today). She says she had a similar but milder reaction to a flu shot given by her primary care provider 1 year earlier, pain lasting 6 months (unknown by me until today).									N	11/16/2004	11/18/2004	2	Nerve transmission study by neurologist reportedly normal.	PVT	UNK		Eczema, hypothyroid, depression, diverticulitis, gastroesophageal reflux disease	status post bilateral mastectomy for breast cancer with lymph node resection on the left.	Severe pain at injection site (right deltoid) started 2 days post injection, radiated down arm to dorsa medial metacarpal area a		1						1	Injection site pain	FLU3~SANOFI PASTEUR~U1516A~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0260281	07/26/2006	IN	77.0	76		M	07/21/2006	Bell's palsy due to flu shot, onset 2 days after administration, diagnosed. Required plastic surgery. Medical record states keratosis. msv				Y						11/02/2005	11/03/2005	1	Brain MRI done 11-11-2005, left cranial nerve changed consistent with Bell's palsy. Medical record states abnormal lab test. msv	PVT	UNK	Simvastatin 40mg, Lovastatin 40mg, Terazosin 5mg	NONE	allergic to morphine, Septra Medical records state hyperlipedemia. msv			1						1	Facial palsy; Keratitis; Laboratory test abnormal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61503~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0260888	07/31/2006	PR	46.0	46		M	07/31/2006	RASH ON BACK AND CHEST.									N	08/15/2005	10/20/2005	66		UNK	UNK						1						1	Rash	ANTH~MICHIGAN DEPT PUB HLTH~~6~IM~UN~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0260963	08/01/2006	CA	4.0	4		M	08/01/2006	Redness, small rash, warmth to right thigh.									Y	07/28/2006	07/29/2006	1	None	PVT	OTH	Fluoride drops MVI with iron	no	None			1						1	Erythema; Feeling hot; Rash	DTAP~SANOFI PASTEUR~U16358A~5~~RL~DTAP (DAPTACEL)~1|FLU3~PARKDALE PHARMACEUTICALS~26902~UNK~~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1|IPV~SANOFI PASTEUR~Y06382~4~~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0237R~2~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0260969	08/02/2006	CA	31.0	31		M	07/31/2006	Diagnosed with Type 1 diabetes in Sept 2004, classic symptoms of polyuria, polydipsia, acidosis,  fatigue and weight loss. Brief hospitalization for IVF's and insulin initiation. Family history of diabetes. 8/3/06-medical records included with VAERS report.  Chief Complaint on visit of 6/20-06:  I was told you were doing research on people who got diabetes after getting the vaccines. HX Present illness: Patient interested in filing a VAERS report regarding the onset of his Type 1 diabetes following receipt of multiple vaccines.  After vaccines of MMR, IPV, TD, Hep A and Hep B on 5/2/05 complained of feeling sick (body aches, fatigue) within 2-3 day period. No local reactions to Typhoid and Influenza vaccines on 5/19/05. Smallpox on 6/13/05 and denies any significantly increased redness, streaking or swollen axillary lymph nodes. C/O pruritus at small pox vaccine site. In August 2005 began to experience increase in drinking water and frequency of urination, weight loss of 5 pounds. Increase intake lots of sugar in his diet to regain weight. Constipation for 2 weeks, back pain, numbness and tingling in legs, felt like feet wouldn't move. Fatigue, continued weight loss, breath fruity, seen in ER blood glucose >300, admitted for ketoacidosis, hospitalized for 7 days.  Family HX: type 1 diabetes and type 2 diabetes. Consulting MD: no fevers or chills, positive for weight loss and anorexia. No blurry vision, no nausea, vomiting or abdominal pain. Positive for polydipsia and polyuria. Positive for nocturia, no dysuria. Positive for musculoskeletal pain in his legs and back. All other pertinent review of systems are negative.  DX: Diabetes Mellitus Type I with symptom onset approximately 3-4 months following multiple vaccinations.  No additional records requested. krk				Y	Y	7		Y	N	05/19/2005	08/01/2005	74	Labs 10/25/05 GAD 65 AB 1.0 (<1.0), Islet cell AB, IFA w/reflex negative, A1C 9.4, Fructosamine 242, urine ketones negative, glucose 138.  DX Tests: 9/3/05-CT pelvis with contrast: no active disease within the abdomen or pelvis. 01/23/06 MRI L Spine w/o contrast, degenerative changes, worst at L5-S1 on the left.	MIL	MIL	NONE					1						1	Acidosis; Blood glucose increased; Diabetes mellitus; Fatigue; Laboratory test abnormal; Polydipsia; Polyuria; Weight decreased	FLU3~SANOFI PASTEUR~~4~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1083P~2~IM~UN~HEP B (RECOMBIVAX HB)~1|HEPA~MERCK & CO. INC.~0917P~2~IM~UN~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~X11892~2~SC~UN~POLIO VIRUS, INACT. (IPOL)~1|SMALL~UNKNOWN MANUFACTURER~4020072~1~~UN~SMALLPOX (NO BRAND NAME)~1|TD~SANOFI PASTEUR~U1354AA~3~IM~UN~TD ADSORBED (NO BRAND NAME)~1|TYP~SANOFI PASTEUR~X08502~1~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Hospitalisation,Disabling	Influenza
0260997	08/02/2006	MA	0.35	0	.4	M	07/28/2006	Fever, mild erythema at injection sites.									U	07/27/2006	07/28/2006	1	NONE	PVT	PUB	TYLENOL	NONE	NONE			1						1	Injection site erythema; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B056AA~2~~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UE830AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08633E~2~~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0261019	08/02/2006	MO	63.0	63		F	08/02/2006	02/06 bursa sac irritation, persistent pain in left arm, 3/06 muscle therapy, 6/06 MRI showed a torn rotator cuff, 6/15/06 surgery for rotator cuff injury, Prednisone x 2 wks refer to ortho.				Y	Y				U	11/15/2005	11/15/2005	0		PUB	UNK						1						1	Arthropathy; Muscle disorder; Pain; Tendon disorder	FLU3~SANOFI PASTEUR~U1881AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0261115	08/07/2006	PR	33.0	33		M	08/03/2006	Joints ache, severe headache, skin problems, photophobia, short term memory loss, eye syndrome, hearing loss, dermatitis, sensorineural hearing loss of combine types, pterygion, polyarthralgia, Blepharitis, allergic conjunctivitis. I am a 36 year old male; after several tests provided by the Medical Center (2 MRI's, DEXA, Bone Scan and XR's from hospital) the results showed that I have develope osteopenia, T11 & T12 collapsed and L5 S1 severe degeneration. There was also found on this tests that I have rheumatoid arthritis.01/1/2010 there is pain in my spinal cord and joints and the medication given to me doesn't lease the constant pain.				Y				Y	U	10/30/2003			Hearing loss, eye syndrome, spine degradation.	MIL	OTH	PPD					1						1	Amnesia; Arthralgia; Blepharitis; Conjunctivitis allergic; Deafness neurosensory; Dermatitis; Eye disorder; Headache; Hypoacusis; Intervertebral disc degeneration; Osteopenia; Photophobia; Rheumatoid arthritis; Skin disorder; Spinal osteoarthritis	ANTH~EMERGENT BIOSOLUTIONS~~4~~UN~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4020071~UNK~~UN~SMALLPOX (DRYVAX)~1	USA	Disabling	Influenza
0261129	08/07/2006	PR	46.0	44		M		Frequent headaches episodes, generalized muscular pain, generalized weakness, hypothyroidism, anxiety disorder, shoulders, knees and ankle joints pain, hearing loss. I received 4 anthrax vaccines in a 40 days period.				Y					N	05/03/2004	12/01/2004	212	high thyroid stimulating hormone	MIL	UNK	NONE	NONE	NONE			1						1	Anxiety; Arthralgia; Asthenia; Blood thyroid stimulating hormone increased; Headache; Hypoacusis; Hypothyroidism; Myalgia	ANTH~EMERGENT BIOSOLUTIONS~~1~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~1~~~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~~1~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0261165	08/07/2006	FL	0.14	0	.1	F	07/31/2006	Cried high pitch cry from 6 pm-2 am, not a whiney baby by history.  Went to emergency room but was never seen.				Y					Y	07/22/2006	07/29/2006	7	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Screaming	DTAP~SANOFI PASTEUR~C2431AA~1~IM~LL~DTAP (DAPTACEL)~1|FLU3~EVANS VACCINES~B08658C~1~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~MERCK & CO. INC.~0514R~1~IM~RL~HEP B (FOREIGN)~1|HIBV~SANOFI PASTEUR~UE879AA~1~IM~LL~HIB (ACTHIB)~1	USA	Emergency room visit	Influenza
0261209	08/08/2006	NY	8.0	8		F	08/07/2006	Total body red rash not pruritic 8 hours after flumist. No fever.									Y	08/03/2006	08/03/2006	0	No	PVT	PVT		No	None			1						1	Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500428P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0261298	08/09/2006	TX	1.52	1	.5	M	08/05/2006	After vaccines he started to just fall down without cause. On 10-19-04 he had a seizure in the morning. Blood work and EEG done, all results negative. No further events after seizure until vaccines given on 4/6/06.				Y					Y	09/16/2004	10/01/2004	15	EEG-negative	PVT	OTH	None	None	None	loss of leg function~Hep A (no brand name)~~3.00~Patient		1						1	Convulsion; Fall	DTAP~SANOFI PASTEUR~C1700AA~UNK~IM~LL~DTAP (DAPTACEL)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~MERCK & CO. INC.~0128P~UNK~IM~~HEP B (FOREIGN)~1|HIBV~UNKNOWN MANUFACTURER~~UNK~~~HIB (NO BRAND NAME)~1|IPV~SANOFI PASTEUR~X1006~UNK~SC~LL~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0261335	08/10/2006	CA	46.0	45		M	04/05/2006	Injection site necrosis Injection site reaction Injection site redness Injection site induration Injection site itching. Medication error Initial report received on 23/Nov/2005 from a health care professional. Per the reporter, several people may have been administered 0.5cc to 1.0cc of TET TOX ADG USP, lot number U1367AA, intradermally in the forearm on 26/)ct/2005. At an unspecified time later, fourteen patients reported redness, induration and itching at the test site. One of those fourteen patients additionally developed necrosis at the test site. At the time of this report, the symptoms were still persisting for all fourteen patients. Follow-up information received on 03/Apr/2006. The patient for this case is a 46 year old male and had no illness at the time of vaccination. Immunization was received on 26/Oct/2005 at 07:45. Recovery status was not reported. No further information expected. The reporter for this case is the same as for cluster of cases 2005-02571, 2005-02572, 2005-02573, 2005-02574, 2005-02575, 2005-02576, 2005-02578, 2005-02579, 2005-02580, 2005-02581, 2005-02582, 2005-02583.				Y					U	10/26/2005				PVT	UNK			Per the reporter, the patient's pre-existing medical history, use of other medication and illnesses at the time of the testing was unknown. It was also reported that is is unknown if this patient had any other vaccinations within four weeks prior to this testing.		200502570	1						1	Injection site erythema; Injection site induration; Injection site necrosis; Injection site reaction; Medication error; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TTOX~SANOFI PASTEUR~U1367A~UNK~ID~~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0261386	08/11/2006	PR	42.0	41		U		Itch, headache, forget thing, lumps, involuntary movement arms and legs, cramps, changes blood pressure, lost power legs and arms.								Y	U	09/17/2004	09/17/2004	0		MIL	UNK	PPD					1						1	Asthenia; Dyskinesia; Headache; Memory impairment; Muscle spasms; Pruritus; Skin nodule	ANTH~EMERGENT BIOSOLUTIONS~~UNK~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~UNK~~~MENINGOCOCCAL (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Disabling	Influenza
0261567	08/15/2006		71.0			F	08/11/2006	Information has been received from the authors of a published literature article, title as above, concerning a 71 year old female with chronic obstructive pulmonary disease and chronic anaemia and a history of breast cancer who in status post lumpectomy and lymph node dissection 1999. IN Oct 2000, the pt was hospitalized for inferior wall myocardial infraction (OCT 2000) and underwent coronary artery bypass with placement of a saphenous vein graft to the right coronary artery RCA and mitral valve repair. Family history included congestive heart failure, brother at age 59, and myocardial infraction, brother at age 67. In approx Dec 2000 the pt was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine, manufacturer unknown, and influenza virus vaccine unspecified. Subsequently the pt developed recurrent reversible dilated cardiomyopathy secondary to viral and streptococcal pneumonia vaccine associated myocarditis. Her case was as follows: On 12/29/2000 the pt presented to the Emergency dept after having been awakened by shortness of breath. The pt denied chest pain, palpitations, dizziness, nausea or diaphoresis. She had recently received pneumococcal pneumonia and flu vaccination. Physical examination was significant for an oxygen saturation of 82% on ambient air, lower extremity edema and pulmonary edema on the chest X ray. ECG revealed sinus tachycardia with Q waves noted in the inferior leads and T wave inversions in the same leads. A TTE was performed, which revealed mild left ventricular enlargement, severe segmental LV dysfunction with severe hypokinesis of the septum, anterior wall, apex and distal lateral wall and hypokinesis of the inferior and posterior walls as well, representing a significant interval change from her previous study. The pt was taken to the cardiac catheterization lab where and angiography revealed a paten SVG to the RCA, normal left anterior descending artery LAD, normal left circumflex artery,but now also showed an ejection fraction of 18% with a kinetic inferobasal and mid inferior walls,mild apical hypokinesis, mild anterobasal hypokinesis and severe anterolateral hypokinesis. The pt was managed in the coronary care unit and treated successfully with diuresis, IV inotropic therapy, digoxin, Angiotensin converting enzyme inhibitor and beta adrenergic receptor blockade. The pt was discharged on 1/5/01. In March 2001, the pt was admitted to the hospital for elective bronchoscopy for work up of a recently discovered lung nodule. TTS at this time revealed mild segmental LV dysfunction, severe hypokinesis of the mid and basal inferior and posterior walls. As compared with the study done on the last hospital admission, there was mild improvement in LV function. In late Dec 2001. the pt was readmitted to the hospital with symptoms of upper respiratory tract infection, complaining of shortness of breath, wheezing, and cough production of white sputum. She had recently received her yearly flu vaccination. Her symptoms began 6 days prior to admission. She denied chest pain, nausea, vomiting, diaphoresis, fever, dizziness or palpitations. IV antibiotics and bronchodilators therapy were initiated. On pulmonary examination, crackles were heard and an echocardiogram was performed to assess LV function and valve anatomy. TTE revealed severe global LV dysfunction again worsened from the previous examination. Five days later cardiac catherization was done to evaluate SVG and coronary artery anatomy, revealing 90% stenosis of the proximal segment of the first right posterolateral RCA branch. Ejection fraction at this time was reported to be 39%. There was no evidence of infarction at this time. Repeat TTE, performed as an out pt, on 2/28/02 showed an improvement in LV function with mild segmental LV dysfunction. Over the next 3 years, the pt was followed as an out pt and had routine echocardiograms performed. In Feb and Nov 2002, TTE showed with mild segmental LV dysfunction with akinesis of basal inferior and basal posterior walls and normal function of the repaired mitral valve, In 2002, the pt did not receive the flu vaccine and she did not have any variation if ejection fraction during that year. Ejection fraction remained at approx 54%. In April 2004, the pt presented to the hospital with URI symptoms, complaining of cough, rhinorrhea and shortness of breath starting the night before admission. At this time, the pt also reported orthopnea. It was reported that in Jan 2004 the pt had undergone an exercise thallium test which revealed no ischemia an ejection fraction was 62%. Cardiac biomarkers were elevated. The pt was admitted to the hospital to rule out myocardial infraction and was tested for URI. A TTE revealed severe segmental LV dysfunction with akinesis of posterior and inferior walls and hypokinesis of the remaining segments. Cardiac catheterization was performed an revealed patency of the SVG to the RCA and a patent stent in the first right posterolateral branch of the RCA. There was mild diffuse disease seen in the midsegment of the LAD. During the hospital stay, the pt had non sustained ventricular tachycardia, with was evaluated with electrophysiology and treated medically. The pt was again discharged without complications. Repeat electrocardiogram was performed as an out pt 1 month later, again showing the reversal of LV dysfunction. This TTE revealed mild segmental LV dysfunction. Since then, the pt has done well and continued to follow up on an out pt basis. The authors reported that myocarditis leading to cardiomyopathy was caused by viral upper respiratory infection and post streptococcal pneumonia vaccine. A copy of the published literature article is attached as further documentation of the pts experienced.					Y	0			Y	12/01/2000	12/29/2000	28	Bronchoscopy 3/01, cardiac catheterization 12/29/00, cardiac catheterization 4//04, chest x ray 12/29/00 pulmonary edema, ejection fraction study 12/29/00 18% 04/04 62%, electrocardiogram 12/29/00, Transthoracic 12/29/00, Transthoracic 02/28/02, Transthoracic 05/04, Transthoracic 4/04, Transthoracic 12/01, Transthoracic 3/01, Ejection fraction study approx 54% during that year, ejection fraction study 12/01 39%, Cardiac 4/04 sustained ventricular tachycardia, cardiac enzyme panel 4/4 elevated, pulse oximetry 12/29/00 82% on ambient air.	OTH	OTH	UNK		Lump excision, lymph node dissection, coronary artery bypass, Myocardial infarction, breast cancer, hospitalization, Mitral valve repair, chronic obstructive pulmonary disease, Anemia.		WAES0608USA00722	1						1	Bacterial infection; Cardiomyopathy; Cough; Dyspnoea; Hypokinesia; Hypoxia; Laboratory test abnormal; Lung disorder; Myocarditis; Oedema peripheral; Orthopnoea; Pneumonia; Productive cough; Pulmonary oedema; Rhinorrhoea; Sinus tachycardia; Upper respiratory tract infection; Ventricular septal defect; Ventricular tachycardia; Viral infection; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0261574	08/15/2006	PR	44.0	44		M	08/03/2006	High temperature, high blood pressure, vision loss, possible glaucoma, muscle ache, anxiety, depression.  11/16/06 Received medical records from VAMC which reveal patient seen 9/03 for acute supurative conjunctivitis.  No other problems noted until 6/05 when eval by neurosurgeon for neck & back pain after falling from truck on deployment 2004.  Disc bulging noted at that time at C4-5, C5-6 &  C6-7.  HNP t L5-S1.  Had received 2 epidural blocks for lumbar pain with some resolution.  Next seen 8/06 by neurosurgeon still c/o LBP & neck pain.  Was receiving PT.  Felt that surgery would not benefit patient & he was to continue PT & meds.  Vaccination record also included with records.				Y				Y	N	02/14/2003	06/08/2005	845		MIL	MIL	PPD					1						1	Anxiety; Blindness; Depression; Glaucoma; Hypertension; Myalgia; Pyrexia	ANTH~EMERGENT BIOSOLUTIONS~FAV088~5~SC~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~MERCK & CO. INC.~~1~IM~~HEP B (RECOMBIVAX HB)~1|HEPA~MERCK & CO. INC.~~1~IM~~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~~1~SC~~POLIO VIRUS, INACT. (IPOL)~1|MEN~SANOFI PASTEUR~~1~SC~~MENINGOCOCCAL (MENOMUNE)~1	USA	Disabling	Influenza
0261653	08/17/2006	PR	39.0	39		M	08/17/2006	NUMBNESS FROM THE WAIST DOWN, LOSS OF FEELING SENSATION (GENITAL AREA), LOSS OF LIBIDO, SUDDEN LOSS OF MEMORY, SWOLLEN LEGS..ARE SOME OF THE ADVERSE EVENTS THE PATIENT IS BEING EXPERIENCING. AT THIS MOMENT PATIENT IS SEEKING TREATMENT AT THE HOSPITAL REGARDING IS LEG & WAIST(NUMBNESS) CONDITION, HIS INABILITY TO NORMALLY FUNCTION (SEXUALLY), AS WELL AS PSYCHOLOGICAL THERAPY. MOST OF THIS EVENTS ARE BEING TAKEN PLACE ONCE THE PATIENT RETURNED FROM DEPLOYMENT ON FEB 2005, AFTER SPENDING ONE YEAR ON THEATER.  02/21/2007 MR received.  Called contact in MR to request EMG full report. Multiple visits beginning 07/03/2006 through 12/10/2007. Initial visit 07/03/2006 for c/o chronic low back pain and shoulder pain.  Also reports anxiety, decreased libido and intermittant numbness over hand, leg, and shoulders. PE: normal, except left forearm scar. Impression: Chronic back and shoulder pain w/o focal neuro deficits or evidence of acute musculoskeletal disorder. Also seen by Psychiatry same day with above complaints and in addition: forgetfulness and increased irritability.  Mental Status Exam WNL except for sad mood and constricted affect. F/u 08/16/2006 for EMG/NCVS for numbness, tingling, and burning sensation in both legs accompanied by back pain.  To R/O radiculopathy vs. neuropathy. PE of 11/06/2006 notes that patient voids well, no changes in urine stream. Otherwise WNL except for a skin fungal infection.				Y					N	12/11/2003	06/01/2005	538	Labs and Diagnostics: UA, CBC and Chemistry WNL except CPK-high at 705, LDH-high at 257, and SGOT high at 43.  CXR normal.  Duplex scan of lower extremities show no evidence of DVT, peripheral venous insufficiency. CT Lumbar spine shows  Paralumbar muscle spasm. Diffuse posterior disc bulging noted at L5-S1.  X-ray lumbosacral spine-normal. Shoulder X-ray shows small spur at the right humoral head, and no fractures or dislocations. 03/05/2007 Brief EMG note already included in submitted MR received which states  Needle EMG and NCS of both LE done today as requested.  ABN: PN (Axonal & Demyelinating Motor) but no Rad.  Complete Report to follow.  No complete report available.	MIL	MIL	NONE. Meds: Celexa.		PMH:  Anxiety.  s/p motor cycle accident.  Allergies:  none noted.			1						1	Amnesia; Hypoaesthesia; Libido decreased; Oedema peripheral; Sensory disturbance	ANTH~EMERGENT BIOSOLUTIONS~~3~IM~LA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~2~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~3~IM~RA~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~3~IM~RA~HEP A (NO BRAND NAME)~1|OPV~UNKNOWN MANUFACTURER~~1~PO~MO~POLIO VIRUS, ORAL (NO BRAND NAME)~1|YF~UNKNOWN MANUFACTURER~~1~IM~UN~YELLOW FEVER (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0261973	08/23/2006	NY	44.0	44		M	08/15/2006	Dizziness, nausea and lightheadedness hearing voices due to dizziness. Symptoms reoccurred however 2 wks later.									Y	12/03/2005	12/04/2005	1	Evaluated by otolyrngologist	MIL	UNK		Dizziness started after dose				1						1	Dizziness; Nausea	FLU3~SANOFI PASTEUR~U1823AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0262056	08/24/2006	KY	64.0	63		M	08/17/2006	3/07/06 Pt in clinic, states had soreness, aches and chills for a few days after flu shot, was given on 2/16/06, then 7-10 days later rash developed near injection site and that was spreading around arm to chest.  Said rash was painful but did not itch, Was seen by Dr and diagnosed with allergic dermititis on this date.  Was given Rx. for Diprolene 0.05% cream Bid, Pt calls on 8/15/06 and stats symptoms improve when uses diprolene cream but never go away.  Wife describes a purple blotches.  Told to F/U with Primary Care Physician.  Pt is adament that he thinks symptoms due to flu shot.									N	02/16/2006	02/23/2006	7		UNK	UNK	Cardizem	none	no		KY2006032	1						1	Chills; Dermatitis allergic; Injection site rash; Pain	FLU3~SANOFI PASTEUR~U1915AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0262099	08/25/2006	NJ	49.0	49		F	08/19/2006	Immunizations administered on 06May06. On 07May06 pt experienced severe headache and vomiting that lasted through 08May06.									Y	05/06/2006	05/07/2006	1	NONE	MIL	MIL	NONE	NONE	Hay fever			1						1	Headache; Vomiting	FLU3~SANOFI PASTEUR~U1869AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABA026AA~1~IM~LA~HEP A + HEP B (TWINRIX)~1|TD~MASS. PUB HLTH BIOL LAB~U1210CA~1~IM~RA~TD ADSORBED (TDVAX)~1	USA		Influenza
0262252	08/29/2006	PR	52.0	49		M		I will attach DD Form 2766 and copy of certificates of vaccination and sign and symptoms. Memory loss with dizziness, trouble remembering recent information, disorientation, insomnia, sleep problems, joint & muscle aches, anxiety, angry, irritable, depression, diabetes mellitus, loss of energy,eye disease, vision problems, hypertension, coordination problems, blood pressure varies, sneezing, weakness, weight loss, joint swelling, lower back pain, back pain, respiratory problems, muscle & joint pain, rib cage pain, eye pain, chest pain, skin itching, Charlie horse,										12/12/2003				MIL	MIL						1						1	Anger; Anxiety; Back pain; Chest pain; Coordination abnormal; Depression; Diabetes mellitus; Dizziness; Eye pain; Fatigue; Hypertension; Insomnia; Joint swelling; Memory impairment; Muscle spasms; Pain; Pruritus; Visual disturbance; Weight decreased	ANTH~EMERGENT BIOSOLUTIONS~~UNK~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0262609	09/05/2006	MI	75.0	76		M	07/25/2006	On 7/6/06 client came to HD stating that on 11/08/05 he had a flu shot that resulted in many untoward side effects necessitating Dr visits and testing. S/s began 2 days after shot with night sweats and one-two wks later needed CXR and antibiotics for Dx of pneumonia or a spot on lung which he is still being followed up for and is scheduled for a CT of lungs. Also saw Dr for hearing loss and sinus problems. Had about 10 Dr visits since onset to date. Coughing resolved but lung spot remains for weeks. Still testing and follow up in process.				Y					U	11/08/2005	11/11/2006	368	Saw Dr and has had Cat scans on sinuses and lung. Dr's watching his lung but client is deferring future flu shots.	PUB	PUB	NONE	NONE	NONE		MI2006014	1						1	Cough; Hypoacusis; Lung disorder; Night sweats; Pneumonia; Sinusitis	FLU3~SANOFI PASTEUR~U1778AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0262657	09/06/2006	CA	18.0	18		M	09/06/2006	Admitted to hospital on Sep 2nd, 2006 with bilateral upper and lower extremity (ascending) weakness, calf pains and intermittent tingling of feet. Vital signs normal, antalgic gait, walks only with assistance. Diagnosed with variant of Guillain Barre, treated with IV Immune Globulin. Remains in hospital at this time, but transferred from ICU to medical ward. 02/08/07-records reviewed  DX: GBS EMG NCS:abnormal study electrophysiologic evidence of severe motor greater than sensory acquired multifocal sensorimotor peripheral neuropathy with axonal greater than demyelinating features. Given the history this likely represents GBS. The prognosis for recovery with predominant axonal features would probably be a protracted course. Presented with progressive weakness and numbness in hands and feet time 3 days. Weakness began first then tenderness in his gastrocs and numbness working its way distal to proximal up to his elbow and knees. History of productive cough since beginning of basic training. No fever, chills or night sweats. Exposed to others with diarrhea but he has not had diarrhea.  Hospital course continued to have weakness in lower extremities mainly feet, also decreased grip strength with no change during ICU stay. Treated with IVIG for 3 days. No change in neuro symptoms or respiratory function transferred from ICU to medical floor and subsequently discharged. 1/29/2010 Last contact with patient : 5/1/09, on disabled retired list with 30% disability. Not back to baseline-still experiencing lower extremity weakness.					Y	5			N	08/29/2006	08/30/2006	1	Abnormal EMG EMG NCS:abnormal study electrophysiologic evidence of severe motor greater than sensory acquired multifocal sensorimotor peripheral neuropathy with axonal greater than demyelinating features. Given the history this likely represents GBS	MIL	MIL	none	none	penicillin allergy			1						1	Blood product transfusion; Disability; Gait disturbance; Gait disturbance; Guillain-Barre syndrome; Hypoaesthesia; Intensive care; Muscular weakness; Myalgia; Myalgia; Nerve conduction studies abnormal; Paraesthesia	FLUN3~MEDIMMUNE VACCINES, INC.~500430P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB061AA~2~IM~LA~HEP A + HEP B (TWINRIX)~1|IPV~SANOFI PASTEUR~Y1051~1~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|TDAP~SANOFI PASTEUR~C2457AA~1~IM~RA~TDAP (ADACEL)~1|YF~SANOFI PASTEUR~VEG01AA~1~SC~LA~YELLOW FEVER (YF-VAX)~1	USA	Hospitalisation	Influenza
0262752	09/08/2006		71.0			F		The vaccinee has a history of Breast cancer including post lump excisions and Lymph node dissection 1999. The vaccines concurrent conditions include chronic obstructive pulmonary disease and chronic anemia. The vaccines family history includes congestive heart failure (brother at age 59) and myocardial infraction (brother at age 67). The vaccinee dose not consume alcohol, was on no medications and has no known history of coronary artery disease prior to October 2000. In Oct 2000, the vaccinee presented to the hospital with a chief complaint of shortness of breath, choking in the throat and a funny feeling in her abdomen. On admission the electrocardiogram revealed ST elevation in II, III, a VP, Q waves in II, III a VF and ST depressions in V1-V. Laboratory date demonstrated elevated cardiac enzymes (CPK peak of 1575 IU/L) consistent with an inferior wall myocardial infarction. On physical examination, the vaccinee was in respiratory distress. She had a harsh III/VI systolic murmur suggestive of mitral regurgitation MR. She was incubated and mechanically ventilated for respiratory distress. A bedside Transthoracic echocardiogram was performed and revealed a myxomatous mitral valve and partial rupture of the posteromedial papillary muscle, as well as severe eccentric mitral regurgitation. Severe hypokinesis of the mid and basal inferior walls were also noted. Emergency cardiac catherization was performed revealing total occlusion of the mid segment of the right coronary artery, normal left anterior descending artery, severe MR, ejection fraction of 40% and elevated means pulmonary capillary wedge pressure of 21 mm HG. coronary artery bypass surgery with placement of saphenous vein graft to RCA and mitral valve repair were recommended and undertaken without complication. The vaccinee was discharged 10 days later. In Dec 2000, the vaccinee received anti influenza vaccine (brand unspecified) and Pneumovax 23. Subsequently the vaccinee developed recurrent reversible dilated cardiomyopathy secondary to viral and streptococcal pneumonia vaccine associated myocarditis. On 12/29/2000 the vaccinee presented to the emergency department after having been awakened by shortness of breath. The vaccinee denied chest pain, palpitations, dizziness, nausea or diaphoresis. Physical examination was significant for any oxygen saturation of 82 percent on ambient air, lower extremity edema and pulmonary edema in the chest x ray. ECG revealed sinus tachycardia with Q waves noted in the inferior leads ant T wave inversions in the same leads. A TTE was performed, which revealed mild left ventricular enlargement, severe segmental LV dysfunction with severe hypokinesis of the septum, anterior wall, apex and distal lateral wall and hypokinesis of the inferior and posterior walls, representing a significant interval change from her previous study on 12/21/2000. The vaccinee was taken to the cardiac catherization lab where angiography revealed a patent SVG to the RCA, normal left anterior descending artery, normal left circumflex artery but now also showed an ejection fraction of 18 percent with akinetic inferobasal and mid inferior walls, mild apical hypokinesis, mild anterobasal hypokinesis and severe anterolateral hypokinesis. The vaccine was treated in the coronary care unit and treated successfully with diuresis, IV inotropic therapy, digoxin, angiotensin converting enzyme inhibitor and beta adrenergic receptor blockade. The vaccinee was discharged on 1/5/2001. In March 2001 the vaccine was admitted to the hospital for elective bronchoscopy for workup of a recently discovered lung nodule. TTE at this time revealed mild segmental LV dysfunction, severe hypokinesis of the mid and basal inferior and posterior walls. As compared with the study done on the last hospital admission, there was mild improvement in LV function. In late 12/2001, the vaccinee was readmitted to the hospital with symptoms of an upper respiratory tract infection,  complaining of shortness of breath, wheezing and cough productive of white sputum. The vaccinee had recently received her yearly flu vaccine. Her symptoms began 6 days prior to hospital admission. She denied chest pain, nausea, vomiting, diaphoresis, fever, dizziness or palpitations. IV antibiotics and bronchodilator therapy were initiated. On pulmonary examination, crackles were heard and an echocardiogram were performed to assess LV function and valve anatomy. TTE revealed severe global LV dysfunction again worsened from the previous examination. Five days later cardiac catherization was done to evaluate SVG and coronary artery anatomy, revealing 90 percent stenosis of the proximal segment of the first right posterolateral branch of the RCA and normal LAD. A coronary stent was successfully placed in the posterolateral RCA branch. Ejection fraction at this time was reported to be 39 percent. There was no evidence of infarction at this time. Repeat TTE, performed as an outpatient, on 2/26/2002 showed an improvement in LV function with mild segmental LV dysfunction. Over the next 3 years, the vaccinee was followed as an Outpatient and had routine echocardiograms performed. A coronary stent was successfully placed in the posterolateral RCA branch. In Feb 2002 and Nov 2002, TTE showed mild segmental LV dysfunction with akinesis of basal inferior and basal posterior walls normal function of the repaired mitral valve. In 2002 the vaccinee did not receive the flu vaccine and she did not have any variation in vaccinee presented to the hospital with URI symptoms, complaining of cough, rhinorrhea and shortness of breath starting the night before admission. AT this time, the vaccinee also reported orthopnea. It was reported that in Jan 2004 the vaccinee had undergone an exercise thallium stress tests, which revealed no ischemia, and ejection fraction was 62 percent. Cardiac biomarkers were elevated. The vaccinee was admitted to hospital to rule out myocardial infarction and was treated for URI. A TTE revealed severe segmental LV dysfunction with akinesis of posterior and inferior walls and hypokinesis of the remaining segments. Cardiac catherization was performed and revealed patency of the SVG to the RCA and a patent stent in the first right post lateral branch of RCA. There was mild diffuse disease seen in the mid segment of the LAD, During the hospital stay, the vaccinee and non sustained ventricular tachycardia, which was evaluated with electrophysiology study and treated medically. The vaccine was discharged without complications. Repeat electrophysiology was performed as an outpatient 1 month later, again showing the reversal of LV dysfunction. The TTE revealed mild segmental LV dysfunction. Since then the vaccinee has done well and has continued to follow up as an outpatient. The authors reported that myocarditis leading to cardiomyopathy was caused by viral upper respiratory infection and post streptococcal pneumonia vaccine. No further information is expected.					Y	0				12/01/2000			Bronchoscopy 3/01 NREP, cardiac 10/00 NREP, catherization 12/29/00 4/04 NREP, cardiac 4/04 NREP, electrophysiology sustained ventricular tachycardia, cardiac enzyme panel 4/04 elevated, cardiac enzymes 10/00 NREP, chest X ray 12/29/00 NREP pulmonary edema, Ejection fraction 10/00 40 percent, ejection fraction 12/29/00 18 percent, study 12/01 39 percent, electrocardiogram 10/00 ST elevations, Pulmonary NREP, Capillary wedge pressure, Pulse oximetry 12/29/00 82 percent on ambient air, Systolic murmur NREP, Transthoracic echocardiography 12/29/00 NREP, Transthoracic echocardiogram 10/00 NREP, Transthoracic echocardiography 3/01 partial rupture of the posteromedial papillary muscle. 12/01/01 02/28/02 05/04 NREP.	UNK	UNK	Concomitant drugs not reported.		History of breast cancer, post lump excision, lymph node dissection 1999. Hospitalization in Oct 2000 for inferior wall myocardial infarction. Underwent coronary artery by pass with placement of a saphenous vein graft SVG to the right coronary artery and mitral valve repair. Concurrent conditions. chronic obstructive pulmonary disease and chronic anaemia. Family history includes congestive heart failure (brother at age 59) and myocardial infraction (brother at age 67).		CVOX200600076	1						1	Abdominal discomfort; Bacterial infection; Cardiomyopathy; Choking; Coronary artery disease; Cough; Dyspnoea; Enzyme abnormality; Hypokinesia; Hypoxia; Laboratory test abnormal; Mitral valve incompetence; Muscle disorder; Myocardial infarction; Myocarditis; Oedema peripheral; Orthopnoea; Pneumonia; Productive cough; Pulmonary oedema; Respiratory distress; Sinus tachycardia; Upper respiratory tract infection; Ventricular tachycardia; Viral infection; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0262925	09/12/2006	ND	28.0	28		F	09/12/2006	A nurse prospectively reported that a 28 year old female subject was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) during an unspecified trimester of pregnancy. On an unspecified date in Oct 2005, the subject received 1st dose of Twinrix. The dated of the subjects last menstrual period and trimester of pregnancy were not reported. On the same day, the subject also received influenza virus vaccine (unknown manufacturer) and a Tuberculin skin test (unknown manufacturer). Follow up information received on 9/8/06 indicated that the subjects pregnancy was complicated by PSOL at 35 weeks. The subject was hospitalised for premature labor on 3/31/06 for less than 24 hours. She was also hospitalized on 4/1/06 and 4/2/06 for greater than or equal to 24 hours. The subject was successfully treated with IV hydration, oral terbutaline (2.5mg every four hours as needed) and oral hydroxyzine (50mg daily as needed). The etiology of the premature labor remains undetermined. Additional information indicated that the subject received multiple oral supplements during pregnancy including Henalmic formula (1 three times daily), enriching greens (1 three timed daily), vitamin A C E (1 two times daily) and prenatal vitamins 1 daily. The subject gave birth via spontaneous vaginal delivery to a normal, male infant on 5/23/06 (39 weeks gestation). The infant weighed 6 lbs and 13 oz's, was 19 3/4 inches in length with and APGAR score of 8 at one minute and 9 at five minutes. Oligohydramnios was noted during labor. No further details were provided.					Y	0			U	10/01/2005				MIL	MIL	Tuberculin, Unknown, Prenatal vitamins, (potassium iodide + potassium sulfate + calcium salt + phosphorus salt + vitamin A + Ascorbic acid + Niacimamide + Thiamine hydrochloride + Riboflavin + vitamin D + Manganese salt + Iron salt + Cobalt				A0580463A	1						1	Premature labour; Unintended pregnancy	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~~1~~UN~HEP A + HEP B (TWINRIX)~1	USA	Hospitalisation	Influenza
0263067	09/15/2006	VA	7.0	6		F	09/11/2006	Developed fever 104.7 about 24 hours after FluMist vaccine. Also c/o lethargy and congestion, headache, and eye hurting. Seen in office 9/8/06 T 98.1. Symptoms resolved 24 hours later.				Y					Y	09/06/2006	09/07/2006	1		PVT	PVT	NONE	NONE	NONE			1						1	Eye pain; Headache; Lethargy; Nasal congestion; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500428P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0263122	09/18/2006	PR	36.0	36		F	09/10/2006	Skin rash, urinary incontinence, alopecia (hair loss), frequency upon urination, weight gain.									N	12/16/2003			She has been with exposure to direct sunlight.  She develops skin itchy, redness and hives develops.	MIL	MIL	Doxycycline, Hyslate, Betamethasone, dipropionate cream	skin rash, weight gain, difficulty remembering	Acne vulgaris, alopecia			1						1	Alopecia; Erythema; Pruritus; Rash; Urinary incontinence; Urticaria; Weight increased	ANTH~EMERGENT BIOSOLUTIONS~~3~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0263157	09/18/2006	CA	0.73	0	.7	F	09/18/2006	Fever to 103.5 after the shot (within 24 hours) and her right leg was swollen and red to the size of a half-dollar.									Y	01/25/2006	01/25/2006	0	None	UNK	UNK						1						1	Injection site erythema; Injection site swelling; Pyrexia	FLU3~SANOFI PASTEUR~U1765FA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0263181	09/19/2006	KY	2.0	2	.1	M	09/15/2006	Mother states that one week after influenza vaccine on 10/31/05 (given in right thigh he began having swelling and redness to right knee, subsequently diagnoses with JRA by DR (as a out PT) (of note a older sib subsequently diagnosed with JRA a few months later.)										10/31/2005	11/07/2005	7		PVT	PUB	NONE	NONE	NONE			1						1	Erythema; Joint swelling; Rheumatoid arthritis	FLU3~SANOFI PASTEUR~U1854AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0263184	09/19/2006	NV	36.0	36		F	09/13/2006	Arm where Tdap given red, swollen, warm to touch, temperature 100.2, lymph nodes in neck swollen. Swelling on arm and lymph nodes swelled 24 hours after injection. Treatment with steroids.				Y					Y	09/11/2006	09/13/2006	2		MIL	MIL	Verapamil, ASA, Triphasil	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site warmth; Lymphadenopathy; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500430P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~MERCK & CO. INC.~0154R~2~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|TDAP~SANOFI PASTEUR~AC52B005AA~1~IM~UN~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0263192	09/19/2006	WI	1.28	1	.3	M	09/18/2006	Started to show symptoms of chicken pox-spots September 13, 2006.  No hospitalization.  Treatments for itchiness and other symptoms.									N	12/15/2004				OTH	OTH	NONE	NONE	NONE	Chicken pox~Varicella (no brand name)~1~3.00~In Patient		1						1	Dermatitis bullous	DTAPH~SANOFI PASTEUR~UE314AA~3~~LL~DTAP + HIB (TRIHIBIT)~1|FLUX~UNKNOWN MANUFACTURER~U1381AA~2~~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0044P~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0263427	09/21/2006	NY	32.0	32		M	09/21/2006	Within 4 hours of receiving vaccine, patient developed fever to 103, nausea, vomiting, diarrhea.  Illness persisted for 4 days when began abating.  Went to ER for 3 liters IV hydration on day 2 of illness.  Ate possibly contaminated food day prior to onset of illness (and flu vaccine).  10/13/06 Received medical records from hospital which reveal patient seen in ER on 9/15 for fever 102.9, aches, weakness, lightheadedness, HA, malaise, chills, vomiting, diarrhea & abdominal pain & pain at injection site with paresthesias of left arm which began after flu vax same day.  Patient reported had similar s/s after previous flu shots but with longer time in between vax & onset of symptoms.  PMH: HIV +, recent c-diff infection s/p tx for sinus infection.  Kept in ER until following day when released home w/final ER dx: immunization reaction.  10/30/06 Received medical records from provider/reporter which reveal patient called on 9/19 & was seen on 9/20 with continued watery diarrhea, fever, chills & low BP. MD spoke with hospital for lab results & felt episode could be related to possibly contaminated food rather than flu shot; however, since it was patients 3rd negative reaction following flu shot, was not to receive any further flu shots./ss				Y					Y	09/15/2006	09/15/2006	0	none	UNK	UNK	Lexapro, Advair, Albuterol	None	HIV, stable off medication.  Asthma. Recent c-diff infection s/p antibiotics for sinus infection.			1						1	Abdominal pain; Asthenia; Chills; Diarrhoea; Dizziness; Headache; Injection site pain; Malaise; Nausea; Pain; Paraesthesia; Pyrexia; Vaccination complication; Vomiting; Abdominal pain; Abdominal tenderness; Asthenia; Blood test normal; Chills; Diarrhoea; Disorientation; Dry throat; Dyspnoea; Faecal incontinence; Fatigue; Heart rate increased; Hyperhidrosis; Hypoaesthesia; Hypokinesia; Hypotension; Malaise; Neuralgia; Pyrexia; Sensory disturbance; Tremor; Urine analysis normal; Visual disturbance	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69898~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~N/A~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0263440	09/22/2006	IN	59.0	59		F	09/15/2006	Redness, heat, swelling and pain in right arm, cellulitis in right arm.  Treated with 1 gram ROCEPHIN to right buttock intramuscular, treated for KEFLEX 500 mg four times a day for 10 days.				Y					N	09/12/2006	09/12/2006	0	NONE	PVT	UNK		NONE	NONE			1						1	Cellulitis; Erythema; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70279~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1008P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0263463	09/22/2006	ND	28.0	28		F	09/22/2006	1 hr after administering, pt began experiancing hoarse voice/ loss of voice. later sx to include fever, swollen lymp nodes, chills, L ear pain.									N	09/20/2006	09/20/2006	0		MIL	MIL		None	None			1						1	Chills; Dysphonia; Ear pain; Lymphadenopathy; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500430P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0263427	09/23/2006	NY	32.0	32		M	09/23/2006	Patient received Chiron Influenza Vaccine at 10:30am on 9/15/2006 on left deltoid.  Within approximately 2 hours patient felt electrical sensation running down the posterior of his left arm to the elbow from the axillary attachement of the left pectoralis.  Shortly thereafter patient experience diarrhea and a slight disorientation accompanied by neuralgia and general malaise.  Approximately 4pm, patient began have extreme chills and uncontrollable shaking.  Patient went home with severe abdominal cramping via subway.  Took some benedryl in transit.  Began sweating profusely, experiencing numbness in the extremities and dyspnea, blackened vision, weakness, difficulty sitting, or standing.  Fever 104, dry throat, repeated diarrhea and abdominal cramping, unable to control bowels.  Patient went to Mount Sinai ER in NYC around 11pm.  Received blood tests and urinalysis.  Patient had extremely tender lower abdomen  Received 3 bags of Saline fluid, 1 bag of Reglin, Tylenol.  Patient released home around 7am the following morning. ER doctors reported that patient had fever, low blood pressure and rapid pulse.  Patient still experiences diarrhea and cramping.  Patient experienced 2 days of migraine like headaches within days following ER release, extreme fatigue.  Missed 1 weeks classes and work.   On 9/20/2006, Patient visited his PCP with vitals of 99.7 temperature, pulse of 56, and BP of 97/70.  Patient still experience fatigue, lack of appetite, diarrhea, abdominal cramping and lower abdoominal tenderness.				Y	Y	1			U	09/15/2006	09/15/2006	0	Blood tests negative for infection. Urinalysis negative for infection	PUB	UNK	Lexapro, Singulair	None	HIV+, Asthma, Mold/Dust/Peanut Allergies,  Norpramine Allergy,			1						2	Abdominal pain; Asthenia; Chills; Diarrhoea; Dizziness; Headache; Injection site pain; Malaise; Nausea; Pain; Paraesthesia; Pyrexia; Vaccination complication; Vomiting; Abdominal pain; Abdominal tenderness; Asthenia; Blood test normal; Chills; Diarrhoea; Disorientation; Dry throat; Dyspnoea; Faecal incontinence; Fatigue; Heart rate increased; Hyperhidrosis; Hypoaesthesia; Hypokinesia; Hypotension; Malaise; Neuralgia; Pyrexia; Sensory disturbance; Tremor; Urine analysis normal; Visual disturbance	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69898~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~N/A~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Hospitalisation	Influenza
0263492	09/25/2006	MT	66.0	65		F	09/18/2006	One hour after the immunization redness, swelling, heat and pain developed at the site left arm deltoid. Clt noted a rapid heart rate as she went to bed at 10:30pm. She awoke at 1:00am from pain at the site. She noted the rapid heart rate also at that time. She fainted and her husband helped her recover from the faint and the went to ER for care.				Y					Y	09/14/2006	09/14/2006	0	EKG negative for heart condition, given Benadryl, ice, Ibuprofen and Tylenol in ER.	PUB	PVT	Celebrex, Ibuprofen	NONE	Osteoarthritis knees.			1						1	Heart rate increased; Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth; Sleep disorder; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70385~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1039P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0263493	09/25/2006	MI	76.0	76		F	02/17/2006	Client states after receiving influenza inj 11/17/05 felt a soreness in her left arm throughout. Client felt soreness was normal until 11/19/05, felt pain under her left arm. Client states her underarm was swollen and felt hot to the touch, she also noticed redness there. These symptoms have continued everyday since then. Client states it is difficult to dress herself, she usually asks her husband to assist her. Client states she received the flu shot approx 5 inches down from the top of her shoulder, on 11/17/05. Client was advised to call her physician to evaluate her arm and under arm client states she will do so.									U	11/17/2005	11/19/2005	2	NONE	PUB	PUB	NONE		Penicillin, Sulfa allergies.		MI2006018	1						1	Erythema; Feeling hot; Hypokinesia; Injection site pain; Oedema; Pain	FLU3~SANOFI PASTEUR~U1935AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0263510	09/25/2006	CA	39.0	39		F	09/21/2006	Seriousness criteria other medically significant (OMIC). Initial report receive on 9/13/06 from a health care professional. A 39 year old female pt had received a left deltoid injection of Fluzone SV 2006-2007, lot number U2204AA, on 9/12/06. Immediately post vaccination, she felt light headed, dizzy and faint. Later the day at home she experienced visual disturbances (floaters) and a blind spot in the visual field of her right eye. Per the reporter, the eye symptoms and dizziness is persisting. The pt has also received a left deltoid first dose injection of Hepatitis A vaccine, lot number 0144F, on 8/24/06. At the time of this report, the pt has not recovered.				Y					N	09/12/2006	09/12/2006	0		PVT	UNK	TYLENOL, FLONASE				200602429	1						1	Dizziness; Syncope; Visual disturbance; Visual field defect	FLU3~SANOFI PASTEUR~U2240AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0263512	09/25/2006	MD	65.0	65		F	12/20/2006	This case was reported by a pharmacist and described a 63-year-old female subject who developed severe flu symptoms after receiving an influenza vaccination (other manufacturer) . There were no concomitant medications or pertinent medical history.  The subject's concurrent medical conditions were not reported.  The subject had a sulfa allergy. On an unspecified date several years ago, the subject received influenza vaccine (unknown manufacturer: dose number and lot number not provided).  On an unspecified date, the subject developed severe flu symptoms after receiving the influenza vaccination.  No other symptoms were reported. No other information was available. This is in follow-up to report (s) previously submitted on 10/16/2006. Information has been received from a physician and a 65-year-old female who is a physician with asthma, allergies (ragweed) and penicillin an aspirin allergies, who on 22-SEP-2006 at 10:30 am was vaccinated subcutaneously in the right arm with a first dose 0.65 ml dose of ZOSTAVAX vaccine (Merck). Concomitant vaccination included: a dose of pneumococcal 23v ploysaccharide vaccine (MSD), a dose of inlfuenza virus vaccine (unspecified) (given on the same arm about 3 inches away from the site of varicella-zoster virus vaccine live (Merck) administration) and a dose of tetanus toxoid vaccine (manufacturer unknown). Other concomitant medications included: ADVAIR, SINGULAIR and ALLEGRA. On 23-SEP-2006 the patient expereinced a severe localized reaction on her right arm including erythema, pain/tenderness, swelling, pruritus and warmth. The patient did not experience any systemic reations, no fever, no sore throat and no joint pain. It was reported that the reaction gradually subsided after 6 days and significantly reduced after 10 days. On 05-OCT-2006, the patient  was seen by the allergist, she still had a mild macular eythema, but no other skin lesions were identified. The patient was also wondering whether she should receive her additional allergy immunotherapy which she is getting about once every 4 weeks. She was also treated in the allergist office for asthma, aspirin and penicillin allergy. The physician discussed the potential etiologies for her raction to varicella-zoste virus vaccine live (Merck). The time sequence may resemble either type-3 or type-4 hypersensitivity. In addition, patch testing for varicella-zoster virus vaccine live (Merck) may also be beneficial which potentially can help us to identify whether she has any T-cell mediated hypersensitivity reaction. There is always a possibility the reaction could be directed to the preservatives. Ingredients of the vaccination have to be examined to see whether additional patch testing can be performed. The physician recommended that she get IgG and IgM antibody titers for VEV. The results of these tests were varicella-zoster Ab, IgM = < 0.90 (negative) and varicellla-zoster V Ab, IgG = 4.24 (positive). The physician noted that the patient could continue her current prescribed allergy and asthma medication and continue to receive her immunothereapy as planned. No product quality complaint was involved. No additional information has been requested.				Y					N	09/22/2006	09/23/2006	1	No lab diagnostic studies were performed. Serum varicella zoster, 10/05/06, 4.24, IgG antibody test, high positive; Serum varicella zoster, 10/05/06, <0.90, IgN antibody rest, negative	OTH	OTH	No concurrent medication ALLEGRA; ADVAIR; SINGULAIR	sulfa allergy Asthma; Penicillin allergy; Drug hypersensitivity; Seasonal allergy	There were no concomitant medications or pertinent medical history.  The subject's concurrent medical conditions were not supported.		A0610558A	1						1	Influenza like illness	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~UN~UN~TETANUS TOXOID (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~0622F~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0263513	09/25/2006	NH				U	09/08/2006	This case was reported by a pharmacist and described the occurrence of an unspecified adverse reaction in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Flu vaccine, manufacturer unspecified) for prophylaxis.  On an unspecified date, the subject received an unspecified dose of Flu vaccine. At an unspecified time after vaccination Flu vaccine, the subject experienced an unspecified adverse reaction.  At the time of reporting, the outcome of the event was unspecified.  This report was received.									U				Unknown	OTH	OTH		Unknown	The subject's medical history, concurrent conditions, and concurrent medications were not provided.		A0613741A	1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0263514	09/25/2006		42.0			F	09/08/2006	This case was reported by a consumer and described the occurrence of severe arm pain in a 42-year-old female subject who was vaccinated with influenza virus vaccine (Flu vaccine, manufacturer unspecified) for prophylaxis.  A physician or other health care professional has not verified this report.  The subject's medical history, concurrent conditions and concurrent medications were not provided.  On am unspecified date, approximately two years from the time of reporting, the subject received an unspecified dose of Flu vaccine (unknown). At an unspecified time after vaccination with Flu vaccine, the subject experienced severe pain and numbness in her left arm.  She thought she was having a heart attack.  She presented to the emergency room where it was determined that she did not have a heart attack.  At the time of reporting, the outcome of the events was unspecified.				Y					U				Unknown	OTH	OTH		Unknown	The subject's medical history, concurrent conditions, and concurrent  medications were not provided.		A0615375A	1						1	Hypoaesthesia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0263515	09/25/2006	VA	60.0			U	09/08/2006	The following report was received from another manufacturer.  This case was reported by a physician and described the occurrence of an unspecified reaction in a 50-year-old subject of unspecified gender who was vaccinated with influenza virus vaccine 9Flu vaccine, manufacturer unspecified for prophylaxis.  On an unspecified date the subject received an unspecified dose of Flu vaccine.  At an unspecified after vaccination with Flu vaccine, the subject experienced an unspecified reaction.  The type of reaction to the flu vaccine was unknown.  The flu vaccine was not given by the reporter.  At the time of reporting the outcome of the event was unspecified.  No further information was available.				Y					U				Unknown	OTH	OTH		Unknown	The subject's medical  history, concurrent conditions, and concurrent medications were not provided.		A0616363A	1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0263516	09/25/2006	VA	80.0	80		M	09/08/2006	This case was reported by a nurse and described the occurrence of worsened arm arthralgia in a 81-year-old male subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis.  The subject's medical history included arm arthralgia prior to receiving the vaccination with Fluarix. His allergies included penicillin, terazosin (Hytrin), clopidogrel (Plavix), hydrochlorothiazide and possibly prednisolone, dexamethasone 9Decadron) and methylprednisone (Depo Medrol).  Concurrent mediations included Aspirin and cholestyramine (Questran lite). The subject had not experienced any reactions after vaccination with previous influenza virus vaccines.  On 11 November 2005, the subject received an unspecified dose of Fluarix (0.5 ml, intramuscular, left arm).  The lot number was ASLUA141BA and the expiration date was 26 July 2006.  At an unspecified time after vaccination with Fluarix, the subject experienced worsened arm arthralgia, which required medical attention at his doctor's office.  At the time of reporting the outcome of the event was worse. Follow-up information on 26 September 2006 indicated that the subject's condition was still not resolved. The subject's physician felt that the event could possibly be related to treatment with FLUARIX.				Y					U	11/11/2005			Unknown	PVT	PVT	Aspirin, Cholestyramine	Unknown	The subject was allergic to Penicillin, Hytrin, Plavix, and hydrochlorothizide. He was possibly allergic to prednisolone, decadron and depomedrol. Follow-up information indicated that the suject only uses alcohol occasionally and does not use tobacco.		A0618114A	1						1		FLU3~GLAXOSMITHKLINE BIOLOGICALS~ASLUA141BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0263519	09/25/2006	MD	65.0	65		F	09/25/2006	24 hours after injection of SHINGLES VACCINE developed local VERY SEVERE SWELLING, REDNESS, PRURITUS, PAINFUL, HOT. 3/4 of the arm, encircling it. Can not sleep because of itching and pain. No systemic symptoms. The patient is a Pediatrician well versed in vaccine reactions. The patient takes Advair 100 for mild asthma. Received a flu shot in the same arm, same date, different area of the arm. At 72 hours the reaction persists.									N	09/22/2006	09/23/2006	1		UNK	UNK		none	Allergic to Penicillin and Aspirin Mild Asthma. Takes Advair 100			1						1	Injection site erythema; Injection site hypersensitivity; Injection site pain; Injection site swelling; Injection site warmth; Pruritus; Sleep disorder; Injection site erythema; Injection site hypersensitivity; Injection site oedema; Injection site pain; Injection site warmth; Pruritus; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1|TD~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~~TD ADSORBED (DITANRIX)~1|VARZOS~MERCK & CO. INC.~~UNK~SC~~ZOSTER LIVE (ZOSTAVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|VARZOS~MERCK & CO. INC.~0622f~UNK~SC~UN~ZOSTER LIVE (ZOSTAVAX)~2	USA		Influenza
0263600	09/26/2006	WA	46.0	46		F	09/26/2006	Rubor, warmth, edema of injection site, pain on touch.									Y	09/25/2006	09/26/2006	1		UNK	UNK			Rheumatoid Arthritis, Goiter, Asthma, Hay fever			1						1	Injection site swelling; Injection site warmth; Pain; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA201BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0263628	09/27/2006	MI	82.0	82		M	09/27/2006	Patient left, ten minutes later returned and said he was light headed. Took his blood pressure it was 60/40 for 3 times.  Called 911 and took his blood pressure and it was 80/nothing. Emergency techs took him to the hospital.				Y					Y	09/27/2006	09/27/2006	0		UNK	UNK	Cardura, Iron, Allopurinol, zoloft, potassium, lopressor, lasix, combivent	Knee pain	Pacemaker, CHF			1						1	Blood pressure decreased; Dizziness	FLU3~SANOFI PASTEUR~U2256aa~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0263641	09/27/2006	NM	24.0	23		F	09/27/2006	8/25 six hours after flu shot received in right deltoid she became hot and her skin was flushed red. She vomited x 1 then went home. She was dizzy and aching across her arms and shoulders. That night she had diarrhea and said to ache, 9/27 she is still feeling achy.									Y	09/25/2006	09/25/2006	0	NONE	MIL	PVT		NONE	Penicillin			1						1	Diarrhoea; Dizziness; Erythema; Feeling hot; Hot flush; Pain; Vomiting	FLU3~SANOFI PASTEUR~U2240AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0263678	09/28/2006	TX	24.0	23		M	09/28/2006	9 days post smallpox vaccination pt presented with pustular lesions spreading from the site of the vaccination to his shoulder and back.				Y					Y	09/21/2006	09/26/2006	5	none	MIL	MIL		no				1						1	Blister; Injection site vesicles; Diarrhoea; Haematemesis; Headache; Influenza like illness; Pain; Pruritus; Rash papular; Rash pustular	SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1|ANTH~EMERGENT BIOSOLUTIONS~FAV103~UNK~IM~UN~ANTHRAX (BIOTHRAX)~2|FLUN3~MEDIMMUNE VACCINES, INC.~5004284P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB061AA~UNK~IM~UN~HEP A + HEP B (TWINRIX)~2|SMALL~PFIZER\WYETH~4020072~UNK~SC~UN~SMALLPOX (DRYVAX)~2	USA	Emergency room visit	Influenza
0263728	09/29/2006	PR	47.0	44		M	09/19/2006	Articulation pains; lower back pain, left arm pain, disorder mental, unknown things.  11/16/06 Received medical records from VAMC which reveal patient experienced chronic low back pain, left knee & shoulder pain.  MRI showed discogenic & degenerative changes of facet DJD & right neural foramina narrowing. No radiculopathy.  Left shoulder subacromial bursitis.  Patient received multiple rounds of PT/OT & continues in chronic pain clinic. Other medical history includes neurosis, histrionic, acute stress reaction, organic affective syndrome, gen anxiety, HTN, osteoarthorsis of knee, LS spondylosis, Major depression with psychosis (with at least 2 hospitalizations, last d/c 1/06)), RVT of right leg, dyslipidemia.			Y		Y	59		Y	N	11/03/2003	12/01/2003	28		MIL	MIL		Headache pain, flu, articulation pain		~Anthrax (Biothrax)~~45.00~In Patient		1						1	Arthralgia; Back pain; Pain; Thinking abnormal	ANTH~EMERGENT BIOSOLUTIONS~~3~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0263734	09/29/2006	TX	69.0	69		F	09/26/2006	Left deltoid site hot to touch, swollen, hard and reddish extending 2 inches. Above elbow used ice pack on Saturday then hot packs on Sunday Thru Monday all signs and symptoms subsided except burns at site on Tuesday.									Y	09/23/2006	09/23/2006	0		OTH	OTH	NONE	NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69428~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0003F~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0263735	09/29/2006	TX	33.0	33		F	09/21/2006	Swelling, pain radiating from left deltoid to triceps area tightness and pressure at site with slight rash.										09/20/2006	09/20/2006	0	NONE	OTH	OTH	Birth control					1						1	Injection site oedema; Injection site pain; Injection site rash; Sensation of pressure	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69428~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0003F~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0263736	09/29/2006	TX	72.0	71		F	09/19/2006	Pt reported that on 09/18/2006 she noted a rash or whelps across her collar bone area but more concentrated on the left side. She denies itching and states that today. 9/19/06 rash appeared to be diminishing.									Y	09/16/2006	09/18/2006	2	NONE	OTH	OTH	Synthroid, Fosamax, Astelin		Hayfever, Demerol, Sulphur drugs.			1						1	Rash; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69428~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0263777	09/29/2006	MD	27.0	27		F	09/29/2006	Pneumovax 9/27, pain 9/28, hospitalized for pain control and IVF 9/29, WBC 26000, usual SBP 105, minimum of 79mmHg through 5 liters of LR IVF. 10/12/06 Received medical records from PCP which reveal patient seen for vax on 9/27 & had rash on RLE for approx 2 weeks.  Visit note of 9/28 indicates patient had bad reaction to pneumonia shot & was sent to hospital for pain control.  Notes indicate she received IVF, tylenol & MSO4 along with steroid & pain was controlled. 11/1/06 Received medical recorsd from hospital which reveal patient experienced severe 10/10 left arm & back pain, HA, tachycardia, heavy sweating, nausea.  Left arm noted to be reddened & tender. After several hours observation & IV pain meds, patient with very little improvement & was admitted for further w/u.   Dx: Pneumovax reaction & hypotension.				Y	Y	1				09/27/2006	09/28/2006	1	see above LABS: WBC 26.3,  CXR & L shoulder x-rays were WNL.  EKG showed sinus tachy with ST & T wave abnormality, ? ischemia. 1/8/07 Received additional labs from hospital: BMP from ER on 9/28 showed slightly low Na of 135.  Blood c/s x2 were neg.  UA showed lactobacillus & staph coag neg.	UNK	UNK		none	asthma			1						1	Headache; Hyperhidrosis; Hypotension; Laboratory test abnormal; Nausea; Pain; Rash; Tachycardia; Vaccination complication; White blood cell count increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70249~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0486F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0263780	09/30/2006	NY	51.0	49		F	09/30/2006	Left arm, swelling, redness, calor x 3 days.Pt given keflex for cellulitis.									Y	09/28/2006	09/29/2006	1	NA	UNK	UNK		NA	NKDA, Asthma, GERD,Vitiligo, Depression			1						1	Cellulitis; Injection site erythema; Injection site swelling; Rash	FLU3~SANOFI PASTEUR~u2256aa~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1036P~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0263781	09/30/2006	OH	79.0	79		F	09/30/2006	PATIENT RECIEVED VACCINE AT AROUND 3:20pm 9/28/06. At around 7pm had itching and hives on arms and a few on chest. Patient's wife called pharmacy ask what they should do. Advised to take benadryl and contact MD if symptoms got worse and to phone their doctor in the morning. Talk to wife following day patient doing fine.									Y	09/28/2006	09/28/2006	0		UNK	UNK						1						1	Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA202AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0263828	10/02/2006	PR	24.0	24		M		I developed the following symptoms after the vaccination and during my deployment (Feb 2004-Feb 2005). Mood swings, blood pressure varies, endurance loss, muscle fatigue, flu-like symptoms, sinusitis and lower back pain.									N	02/03/2004				MIL	MIL						1						1	Asthenia; Back pain; Fatigue; Influenza like illness; Mood swings; Muscle disorder; Sinusitis	ANTH~EMERGENT BIOSOLUTIONS~FAV075~1~~UN~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4031003~UNK~~UN~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~UN~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0263846	10/02/2006	PA	0.8	0	.8	M	10/02/2006	This case was reported by a lawyer and described the occurrence of neurological injury in a male subject who was vaccinated with hepatitis B vaccine (Engerix B) and or unidentified hepatitis B vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of hepatitis B vaccine.  According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced serious and permanent neurological injuries: which were attributed to  toxic mercury exposure.  The following information was received via medical records.  The subject was vaccinated with hepatitis B vaccine (Engerix B) on January 1994, 28 March 1994, and 19 July 1994.  The subject was also vaccinated with combination diphtheria and tetanus toxoids, pertussis adsorbed and Haemophilus influenzae type B conjugate vaccine and strain not specified (MMR vaccine) for prophylaxis.  The subject had a history of recurrent ear infections/ middle ear effusion with insertion of ventilation tubes of 18 months of age, and treatment with antibiotic therapy.  According to the mother, the subject's development was normal until 15 months of age,  and he experienced regression at 18 months of age when he stopped speaking.  Upon examination on 09 August 1996, it was noted that the subject was seeing a speech therapist who felt he was behind, although definite (speech) retardation, was not seen.  Assessment included speech delay, question behavior related. On that date, Totramune and oral polio vaccines were administered as the subject was behind on his shots.  On 19 November 1996, the subject was evaluated for a high fever of 104 degrees Fahrenheit, and it was noted that he had experienced possible febrile seizures in the past.  A progress note dated 10 January 1997 indicated that the subject's parents were seeking a referral to an autism clinic to determine why he was not speaking.  Following evaluation in August 1997, impression included developmental delay with questionable autism.  An audiological evaluation on 24 October 1997 resulted in a diagnosis of grossly normal hearing in at least one ear.  In May 1998, the subject was diagnosed with attention deficit hyperactivity disorder, rule out mood disorder, and moderate mental retardation.  He was described as a danger to self, mom, dog, and others, and exhibited increasing aggression.  Medications included olanzapine and clonidine.  In June 1999 the subject was seen for concerns of aggression with jumping, lack of fear, frequent falling, destructiveness, head banging, and eating non food items.  Treatment at that time included PAXIL, olanzapine, and clondidine.  Per the subject's mother, RITALIN had made his behavoir worse.  It was noted that he had not been formally diagnosed with autism; however his mother referred to him as autistic.  The subject had very limited speech and made car noises and monkey noises.  He was successfully using sign language and a sign board.  According to an evaluation performed on 01 September 2000, the subject had also been diagnosed with attention deficit hyperactivity disorder, which had been treated in the past with PAXIL, Adderall, and ZYPREXA.  Additionally it was noted that the subject experienced episodes of bizarre behavoir which appeared to be associated with exacerbations of chronic gastrointestional distress.  By July 2001, the subject was described as capable of ambulation but only for short distances, after which he either tired out easily of refused to move.  In September 2001, a physician's letter described the patient as autistic with self destructive and harmful behaviors, and virtually impossible to toilet train.  In July 2002, the subject's autism was described as profound, and he required physical and  toilet train.  In July 2002, the subject's autism was described as profound, and he required physical and occupational therapy.  A psychiatric examination in November 2003 included a description of the subject as autistic and mentally retarded with profound violent tendencies.  In January 2004, the subject's medications included clonidine, DEPAKOTE, and trazodone.  This case was assessed to be medically significant.  (OMIC)									U	07/19/1994				PVT	OTH					A0621527A	1						1	Abnormal behaviour; Aggression; Autism; Convulsion; Gastrointestinal disorder; Hypoacusis; Mental retardation severity unspecified; Otitis media; Psychomotor hyperactivity; Pyrexia; Speech disorder	DTAP~UNKNOWN MANUFACTURER~~UNK~~~DTAP (NO BRAND NAME)~1|DTPHIB~PFIZER\WYETH~~UNK~~~DTP + HIB (TETRAMUNE)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~ENG1318A2~3~IM~LA~HEP B (ENGERIX-B)~1	USA		Influenza
0263856	10/02/2006	OR	2.0	2	.3	M	09/28/2006	No adverse events, we were instructed to report to VAERS because vaccine was given to a pt under 18 yrs old.									U	03/26/2006				PVT	PUB	Amox	Sinusitis	Hirschprungs disease			1						1	Medication error	DTAPH~SANOFI PASTEUR~U13873CA~1~IM~LL~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~U1787AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABA026AC~1~IM~LL~HEP A + HEP B (TWINRIX)~1|MMR~MERCK & CO. INC.~0296R~1~IM~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08635C~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0263863	10/02/2006	CA	91.0	91		M		Severe muscle soreness.									N	09/27/2006	09/29/2006	2	NONE	OTH	PVT	Caduet, Dyazide, ASA, vitamins		HTN, Cancer, hepatitis, gall stone surgeries,			1						1	Myalgia	FLU3~SANOFI PASTEUR~U2240AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0263880	10/02/2006	IL	72.0	72		F	10/02/2006	Rt. arm was very swollen, red and tender from the shoulder to elbow.				Y					Y	09/29/2006	09/29/2006	0		PUB	PUB	allergy injections and asthma inhalers		allergies to dust and mold; asthma			1						1	Erythema; Oedema peripheral; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69480~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0674F~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0263882	10/02/2006	WA	39.0	39		F	10/02/2006	general itching, redness (flushed), diaphoresis, some shortness of breath, seen in ER, dx:  allergic rxn to FLUMIST				Y					Y	09/25/2006	09/25/2006	0		UNK	UNK		None reported	stated after rxn started that she had exercised induced asthma			1						1	Dyspnoea; Erythema; Flushing; Hyperhidrosis; Hypersensitivity; Pruritus	FLUN3~MEDIMMUNE VACCINES, INC.~500431P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0263921	10/03/2006	CA	53.0	53		U	09/15/2006	Hives possibly from flu vaccine reddened patches through out body itching.				Y					Y	09/12/2006	09/14/2006	2		PVT	PVT	Estroven (OTC)		NONE			1						1	Erythema; Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U2240AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0263923	10/03/2006	HI	4.0	4		F	09/27/2006	On 9/21/06 developed maculo papular clusters confluent pink non tender but mildly purpuric rash consume anterior chest, and back. Rash intensity varied for first 2-3 days but steadily resolved so that by 9/27/06 the rash was minimal Not erythematous and barely palpable).									Y	09/19/2006	09/22/2006	3	NONE	PVT	PVT	NONE		NONE			1						1	Rash maculo-papular; Rash pruritic; Skin discolouration	FLU3~SANOFI PASTEUR~U2237AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0651F~1~IM~RA~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~Y1068~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~0815F~2~SC~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0263926	10/03/2006	TX	60.0	59		F	10/02/2006	Swelling in deltoid region on Saturday. Pt said felt kind of tender. Sunday swelling went down but felt kind of warm to the touch. Monday no swelling in deltoid area but there is redness toward outer aspect of biceps and feels warm to the touch no pain.										09/29/2006	09/30/2006	1		UNK	UNK	Combivent inhaler, Actonel, Hydrocodone, Zocor.		Osteoporosis, Emphysema, remission cancer.			1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U2108AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0263931	10/03/2006	TN	5.0	5		M	10/03/2006	Temperature to 103, malaise, headache, myalgias developing after 48 hours from vaccination.				Y					Y	09/29/2006	10/01/2006	2		UNK	UNK		None, recovered from asthma				1						1	Headache; Malaise; Myalgia; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500435p~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0263932	10/03/2006	NY	73.0	73		M	10/03/2006	Received vaccine on 9/28/2006.  On 10/2/2006 Patient reported through a third party that he developed a 'rash' two days later. Asked him (through third party) to go to his doctor.  Doctor stated he had 'hives'.									Y	09/28/2006	09/30/2006	2		UNK	UNK						1						1	Rash; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70279~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0263934	10/03/2006	LA	0.0	23		M	10/03/2006	10-02-06 Pneumavax 23 vaccination sq to rt arm and Influenza vaccine IM lt arm in early am. Reported flu like symptoms and swelling and warmth to rt arm symptoms started at about 12 am.									Y	10/02/2006	10/03/2006	1	None	UNK	UNK		No	No			1						1	Feeling hot; Influenza like illness; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69480~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0003F~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0263935	10/03/2006	LA	0.0	23		M	10/03/2006	10-02-06 Pneumovax 23 vaccination sq to rt arm and Influenza vaccine IM lt arm in early am. Reported flu like symptoms and swelling and warmth to rt arm symptoms started at about 12 am.									Y	10/02/2006	10/03/2006	1	None	UNK	UNK		No	No			1						1	Feeling hot; Influenza like illness; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69480~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0003F~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0263942	10/03/2006	GA	36.0	35		M	10/03/2006	Pt is a 37 year old male who reported no problems with his health until early Feb 05. He stated he was vaccinated for anthrax and when questioned because his records showed he received small pox and declined anthrax, he stated that he was told to keep the area covered until the scab came off and to take precautions with laundry. He initially reported problems with night sweats and problems breathing and stated he was eventually diagnosed with sarcoidosis. He stated he took steroids and methotrexate and began to feel better and was eventually cleared to deploy with his unit in Oct. He received additional immunizations, but does not recall which ones but stated he had no problems following subsequent immunizations. In Dec 05 he experienced a sudden onset of weakness on the right side of face, along with problems closing his eye, and drooling, He also noted at the same time hearing loss and headaches on the right side of his head. He denied these symptoms prior to the onset of facial weakness and sought immediate medical attention. He was diagnosed with Bells palsy and eventually returned to state side. He reports continued problems with the headaches and facial weakness and states that there is little improvement in his symptoms despite taking the medication. He reports the headaches are no constant, whereas it would have pain free periods the first month, on the right side of his head rated # on scale of 1-10 and 10 being worse. He stated at times the pain may reach 10 and it sometimes wakes him up at night. He stated it is like a giant toothache and is always there, never pain free and stated Midrin helps only a little, He denies photosensitivity, nausea, altered sensation, and neck pain. He stated that his hearing problem started with the onset of his Bells palsy and that he occasionally has ringing in his right ear only, especially when his headache is severe. Clamminess 02/2005, dyspnea (shortness of breath) 02/2005, Facial nerve paralysis/palsy 12/2005, head pain 12/2005 comment rt side of head. Hearing loss 12/2005				Y					N	01/15/2005	02/01/2005	17	6/23/05 chest X ray evidence of hilar and mediastinal adenopathy representing either benign or malignant process such as sarcoidosis metastatic disease etc. 2/6/06 MRI brain with Gadolinium normal. Specifically no abnormalities are noted along the course of the right facial nerve. 2/6/06 pulmonary function test a sarcoidosis normal spirometry. No significant change in FEV1 post bronchodilator treatment. Normal lung capacity. There is air trapping with residual volume of 46% of TLC. There is mild reduction in diffusion capacity which normalized after adjustment for alveolar volume. 2/8/06 MRI internal auditory canal normal. 2/9/06 Biopsy of RT arytenoid mass squamous mucosa with no lesion. No non necrotizing granulomas identified.	MIL	MIL						1						1	Asthenia; Cold sweat; Drooling; Dyspnoea; Eye disorder; Facial palsy; Headache; Hypoacusis; Laboratory test abnormal; Night sweats; Pain; Sarcoidosis; Sleep disorder; Tinnitus	FLU3~SANOFI PASTEUR~~1~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SMITHKLINE BEECHAM~AHBVB004AA~3~~UN~HEP B (ENGERIX-B)~1|SMALL~PFIZER\WYETH~4020072~1~~UN~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~X08622~1~~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0263991	10/04/2006	MA	1.51	1	.5	M	09/30/2006	8x6 cm redness with about 4cm no indurated center left upper arm with Dtap site non tender no fever not ill.										09/28/2006	09/29/2006	1		PVT	PUB	NONE	NONE	NONE			1						1	Injection site erythema; Injection site reaction	DTAP~SANOFI PASTEUR~U1635BA~4~IM~LA~DTAP (TRIPEDIA)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~U2174DA~3~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0263992	10/04/2006	NJ	35.0	35		F	10/04/2006	Experienced gripping chest pain, a sharp pain when breathing. Had to sit and rest for 1 hour continued to rest the after noon. Today feels fine.									Y	10/03/2006	10/03/2006	0		OTH	PVT	Topical cortisone	No	Aspirin and hay fever allergies.			1						1	Chest pain; Dyspnoea	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0264000	10/04/2006	GA	87.0	87		F	10/04/2006	Patient said arm was swollen and she was complaining of being tired and achy all-over.									U	10/03/2006	10/03/2006	0		UNK	UNK	Not known	None	Unknown			1						1	Fatigue; Pain; Swelling	FLU3~SANOFI PASTEUR~U2256AA~2~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1036P~2~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264009	10/04/2006	OR	45.0	45		M	10/04/2006	Within 10 hrs of vaccine, patient developed redness, swelling and tenderness limited to outer area if right bicep. Wife called me to report this the next afternoon. Symptoms hadn't worsened or spread since night before, so I recommended application of ice pack to site 10 min on, 10 min off as needed for comfort and ibuprofen as needed.									U	10/02/2006	10/02/2006	0	none	UNK	UNK	none	none	none			1						1	Erythema; Swelling; Tenderness	FLU3~SANOFI PASTEUR~u2240aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1036p~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264012	10/05/2006	TX	1.32	1	.3	M	10/04/2006	Redness to right thigh 13x15cm and swelling.				Y					U	10/03/2006	10/04/2006	1	NONE	PVT	PVT	Tylenol	NONE	NONE			1						1	Injection site erythema; Injection site oedema	DTAP~SANOFI PASTEUR~C2649AA~4~~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2257AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08682A~4~~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0264059	10/05/2006	NY	4.0	4		M	10/05/2006	Right arm edematous and warm to touch above the elbow, no fever or tenderness.									Y	10/03/2006	10/05/2006	2		UNK	UNK	polyviflor	mild cough no fever	none			1						1	Injection site warmth; Swelling	DTAP~SANOFI PASTEUR~c2650aa~1~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~u2195aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0699f~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0264061	10/05/2006	ME	45.0	45		F	10/05/2006	Pt received flu shot at 11:00am.  At 11:05, pt reported feeling numbness in left arm and lip, tingling in head, and flushing. Admin Benadryl 50 mg PO.  At 11:15 am, pt reports relief of symptoms.  No rash, itching, or hives noted at any times.  No resp symptoms present.									Y	10/04/2006	10/04/2006	0		UNK	UNK	unknown	none reported	none known			1						1	Flushing; Hypoaesthesia; Hypoaesthesia oral; Paraesthesia	FLU3~SANOFI PASTEUR~U2256AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264062	10/05/2006	OH	23.0	23		F	10/05/2006	On 10/3/06  started itching all over body around 2:30pm-3:00pm and Right eye swelling started called Dr.  Put on Prednisone 10 mg, taking 6 tablets one day and reducing down by one until gone.  Went to see Dr. on 10/05/06 had albuteral breathing treatment, advised to use Advair Diskus 100/50 1 puff twice a day until better.  Also told to get Benadryl 25mg 1 pill twice a day, and artificial tears to help with swelling of eye.									N	10/02/2006	10/03/2006	1		UNK	UNK	1/2 Synthroid 125mcg	none	Amoxicillan, Biaxin, and gentamyacin			1						1	Eye swelling; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69427~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0264064	10/05/2006	AZ	68.0	68		F	10/05/2006	Teary left eye, dripping left nostril, then drooling out of left side of mouth when eating, numbness entire left side of face down to chest including throat and neck. Eye does not close. Mouth when smiling droop on left side - can't smile, can't pronounce words with P or B- can't form whistle type mouth. Had flu injection Sat. afternoon and Mon afternoon developed symptoms. First thought could then when couldnt eat dinner without drooling and numbness, went to E.R. Had CT scan, various blood tests until l0:30 that night, and they thought it was Bells Palsy but could not be sure positively if it was a stroke.  I was referred me to my internist where I went Tues morning. He would like to do an MRI to completly rule out stroke but I said to wait. Meanwhile I am taking prednisone 20 mg. 4 for three days, 3 for three days, 2 for two days and l for one day along with Valtrex 1 gram 2 x a day for 7 days along with various eye ointments to keep my left eye lubricated (as it is blood red and hurts) along with wearing a patch.  Do not know at this time how much, if any, permanent damage this shall leave me with nor how long this shall continue with my entire left eye, head, face and neck and throat being numb.				Y				Y	Y	09/30/2006	10/02/2006	2	There are no lab tests for Bells Palsy; but one can see the sudden onset and objective and symptomatic signs by looking and/or talking with me or seeing me eat. I have taken flu shots as long as they have been available in years back and here since 1995 to the present time and had NO REACTION.	UNK	UNK	Rhythmol 225 mg. 3x day;Toprol XL 25 mg. l x day  and a baby aspirin l x day for afib problems for heart;Prilosec 20 mg. lx day for GERD; Levoxyl .l25- 5  days a week and .112- 2 days a week for thyroid replacement since I had my thyroid re	None other than noted in pre existing	Allergies: Adhesive tape; sulphur and penecillin Heart atrial fibrillation Valley Fever in 1997 -  Lung resection in March 1998 for Valley Fever they thought might be CA and was just Valley Fever Appendectomy 1956 Left breast biopsy for microcalcification benign Thyroid CA -thyroid removal followed by I-131 radiation drink in 1982 Right knee arthroscopic surgery 1990 Polpypectomy uterine benign 1972 about or earlier Eyelid surgery 2004 Summer Broken right foot bone 1983 Mitral Valve Prolapse Auto Accident with multiple musculoskeletal problems 1989			1						1	Drooling; Facial palsy; Hypoaesthesia; Lacrimation increased; Nasal congestion; Speech disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Disabling	Influenza
0264065	10/05/2006	AZ	26.0	26		F	10/05/2006	Had influenza shot on Tuesday Octboter 2 around 1:00pm.  No complications Tuesday night.  On Wednesday, noticed about a baseball size red welt at injection site severe redness, tenderness, and warmth at sight.  Also experienced all over body burning sensation, like a hot flash.  No visible signs of inflammation or redness on outward skin.  Felt as like internal cooking.  Felt sunburn like but with no redness.  Was unable to get any sleep due to soreness of arm or hot flash sensations.  Was advised by employee health to take ibuprofen.  I took ibuprofen 800mg x 2 doses and hot flashes resolved but came back after ibuprofen wore off.  Redness and swelling at arm is not resolved at this time									U	10/02/2006	10/03/2006	1		MIL	OTH	Advair 250/50, Aleve	allergies, getting over sinus infection	Allergy to Iodine and injected iodine dyes.  Medical conditions of asthma, allergies, pseudotumor cerebri, migraines	Developed a chicken pox at site of administration~Varicella (no brand name)~1~0.00~Patient		1						1	Hot flush; Injection site erythema; Injection site pain; Injection site warmth; Sleep disorder; Thermal burn; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0264067	10/06/2006	GA	66.0	66		F	10/05/2006	Shot was administered around 12:30pm. Pt complained of severe pain at 3:30pm. She went to Dr at 4:00 but they could not see her. 4:15 she went to ER. ER nurse gave IV injection of Dilaudid and nausea med. ER took X ray of shoulder. Was given another inj of Dilaudid. Sent home with RX for prednisone, pain, muscle relaxants.				Y					N	10/02/2006	10/02/2006	0		OTH	PVT			Macrodantin			1						1	Shoulder pain	FLU3~SANOFI PASTEUR~U2256AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1036P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0264098	10/06/2006	IL	55.0	55		F	10/06/2006	Very ill 12 hours after receiving both the flu and pneumococcal vaccine in same arm.  Sore arm, extreme chills, fever, body aches, no appetite, very thirsty.  Can't imagine how flu could have been any worse.  This is 2 days later and am still extremely tired.  Arm still quite sore and cannot lay on that side not yet.  Husband wanted me to go to hospital 1st night it was so bad.										10/04/2006	10/05/2006	1		OTH	UNK		NONE	NONE			1						1	Chills; Malaise; Myalgia; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0264099	10/06/2006	TX	36.0	36		F	10/05/2006	Right deltoid hump, skin rash, abdomen rash, back 10/5/06-slight dizziness, slight dumpiness of tip of tongue.									Y	10/05/2006	10/05/2006	0	NONE	PVT	PVT	ALLERGA (allergy medicine)	NONE				1						1	Dizziness; Rash; Skin nodule	FLU3~SANOFI PASTEUR~U2239AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264108	10/06/2006	CA	35.0	35		F	10/06/2006	Pt had slight tingling of left pinkie finger after receiving vaccine.She felt flushed and felt slightly sweating. Pt was anxious and felt she had heightened sense of awareness. Called paramedics. Pt had a BP of 107/60 and a HR of 70. Pt states her BP is usually low and 107/60 was normal for her. Patient states she feels tingling over entire body. Gave pt 50 mg of Benadryl IM. Released patient to EMT. After examining patient, EMT released pt and asked her to buy some oral benadryl. Warned patient about possible drowsiness with Benadryl injection.  Followed up with patient on 10/06/06. Pt states she is fine and has had no further problems.									Y	10/04/2006	10/04/2006	0	BP 107/60 HR 70	UNK	UNK	Unknown	None	None/unknown			1						1	Anxiety; Blood pressure decreased; Flushing; Hyperhidrosis; Paraesthesia; Sensory disturbance	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70277~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0264111	10/06/2006	TX	61.0	61		F	10/06/2006	Pt. states she woke up on 10/5/05 at 3:00 am with chills.  Left arm began to get very sore and erythmatous along with swelling.  Saw a physician on 10/6/06 at 11:00 am who diagnosed cellulitis and was put on Z-pak and ice packs, and was instructed to go to the ER if the site worsens.  There was some discrepancy on the site of each vaccine; pt. states she thought the influenza vaccine was given first in the right arm; and the pneumovax vaccine was given second in the left arm.  Also, pt. does not remember feeling the left arm being wiped with alcohol swab.				Y						10/04/2006	10/05/2006	1		UNK	UNK		None	PCN, duracef, silk			1						1	Cellulitis; Chills; Erythema; Pain; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70736~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0002F~4~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0264113	10/06/2006	SC	48.0	48		F	10/06/2006	8cm diameter area of erythema, increased warmth, and tenderness at site of injection.				Y					U	10/03/2006	10/06/2006	3		UNK	UNK			Hypertension, depression, anxiety, gastric reflux, rheumatoid arthritis			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U2275AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~~HEP A + HEP B (TWINRIX)~1	USA	Emergency room visit	Influenza
0264114	10/06/2006	TX	5.0	5		M	10/06/2006	PATIENT DEVELOPED LIP SWELLING, PERIORBITAL SWELLING, AND HIVES  AFTER ARRIVING AT HOME FROM THE DOCTORS OFFICE.  WAS TAKEN TO THE EMERGENCY ROOM WHERE EPINEPHRINE, ZANTAC, BENADRYL AND PREDNISONE WERE GIVEN.  PATIENT RECOVERED QUICKLY.			Y	Y					Y	10/04/2006	10/04/2006	0	NONE DONE	UNK	UNK	ZONOGRAM, CLONIPIN	NONE	HISTORY OF ANGELMANS SYNDROME (SEIZURE DISORDER)			1						1	Face oedema; Periorbital oedema; Urticaria	FLU3~SANOFI PASTEUR~U2180AA~5~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1008F~2~IM~RL~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~0802F~2~SC~LL~VARICELLA (VARIVAX)~1	USA	Life Threatening	Influenza
0264119	10/06/2006	AZ	47.0	47		F	10/06/2006	Burning sensation about an hour after shot.  Redness past the shot area about 3 inches in diameter.  Continued burning for one day.  Hoarse throat, and difficulty breathing.  Low grade fever, thought maybe I just had a cold, but art is very sore and very red 30 hours later.  Throat not as sore, have taken allergy pills and advil.									U	10/05/2006	10/05/2006	0		UNK	UNK		slight cough	none known			1						1	Dysphonia; Dyspnoea; Injection site erythema; Pharyngolaryngeal pain; Pyrexia; Thermal burn	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0264125	10/06/2006	GA	70.0	70		F	10/06/2006	Patient was administered expired flu vaccine consulted with district, state, authority, and manufacturer-revaccinated 10/05/06 no problem from expired flu vaccine.									Y	10/03/2006	10/03/2006	0	NONE	PUB	PVT	NONE	NONE	No Known allergies		GA06053	1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U1930AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264126	10/06/2006	GA	73.0	73		M	10/06/2006	Patient administered expired flu vaccine consulted with district, state, agency and manufacturer-revaccinated on 10/5/06 no problem with expired flu vaccine.									Y	10/03/2006	10/03/2006	0	NONE	PUB	PVT	NONE	NONE	No known allergies		GA06052	1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U1930AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264127	10/06/2006	GA	75.0	75		M	10/06/2006	Pt administered expired flu vaccine consulted with district, state, CDC and manufacturer. Revaccinated on 10/05/2006 no problems from expired vaccine.									Y	10/03/2006	10/03/2006	0	None	PUB	PVT	None	None	NKA		GA06051	1						1	Medication error	FLU3~SANOFI PASTEUR~U1930AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264128	10/06/2006	GA	78.0	78		F	10/06/2006	PT administered expired flu vaccine notified district, State and manufacturer, revaccinated 10/05/06 no problems from expired vaccine.									Y	10/03/2006	10/03/2006	0	NONE	PUB	PVT	NONE	NONE			GA06050	1						1	Medication error	FLU3~SANOFI PASTEUR~U1930AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264129	10/06/2006	GA	76.0	76		M	10/06/2006	Pt was administered expired flu vaccine consulted with district, state, and manufacturer, revaccinated 10/05/06 no problems from expired vaccine.									Y	10/03/2006	10/03/2006	0	NONE	PUB	PVT	NONE	NONE	NKA		GA06049	1						1	Medication error	FLU3~SANOFI PASTEUR~U1930AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264130	10/06/2006	GA	76.0	76		F	10/06/2006	Pt was administered expired flu vaccine consulted with district, state, CDC and manufacturer, revaccinated 10/05/06 no problems from expired vaccine.									Y	10/03/2006	10/03/2006	0	None	PUB	PVT	None	None	None Known		GA06048	1						1	Medication error	FLU3~SANOFI PASTEUR~U1930AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264131	10/06/2006	GA	77.0	77		M	10/06/2006	Pt was administered expired flu vaccine consulted with district, state, and manufacturer, revaccinated 10/05/06 no problems from expired vaccine.									Y	10/03/2006	10/03/2006	0	NONE	PUB	PVT	NONE	NONE	NKA		GA06047	1						1	Medication error	FLU3~SANOFI PASTEUR~U1930AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264132	10/06/2006	GA	72.0	72		F	10/06/2006	Pt received expired flu vaccine consulted with district, state, CDC and manufacturer, revaccinated 10/05/06 no problems from expired vaccination.									Y	10/03/2006	10/03/2006	0	NONE	PUB	PVT	NONE	NONE	NKA		GA06054	1						1	Medication error	FLU3~SANOFI PASTEUR~U1930AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264137	10/06/2006	TN	6.0	6		M	10/02/2006	Child received FluMist per protocol and after review of signed consent form on 9/26/06 an AM at school clinic conducted by health dept. Mom reported child played football that evening. After school on 9/27/06 mom noticed redness around nose, inside of nose and under eyes. On 9/28/06 child went to school with same amount of redness on his face. On 9/28/06 at 10:00am, the school called the parent due to an increase in the redness. Mom took the child to Dr who evaluated the rash. Mom was asked if it was poison ivy. Mom stated no that she thought it was a reaction to receiving the FluMist vaccination two days earlier. Dr gave child oral Benadryl and cortisone cream with instructions to return if condition worsened. Mom gave the child cortisone cream but there was no positive effect. Child was a little itchy but Benadryl controlled the itch. Mom returned to Dr on 9/29/06 because reddened area had spread to trunk and extremities. Area around face (nose, nostrils, and under eyes) was slightly raised and contiguous (as reported by mom). Area on body (trunk and all extremities front and back) was speckled (as reported by mom). Mom reported that reddened areas became slightly raised but did not weep. Dr gave child Oraped and Benadryl orally Q 6 hours PRN. Mom took pictures of child on 9/29/06 to document affected areas. Mom said that she would send copies of the photos for reference. On 10/2/06 in the afternoon, nurse manager notified director of nursing of childs reaction and clinic management of the condition. Director of Nursing was able to contact mom the morning of 10/3/06 to discuss events and gather information for VAERS. They informed mom that they were submitting VAERS and reporting the incident to the vaccine manufacturer. In addition they recommended that mom talk with their pediatrician before receiving another influenza vaccination. Mom reported that child was recovering fine but still has some redness.									Y	09/26/2006	09/28/2006	2	NONE	PUB	PUB	NONE	NONE	Allergic to Augmentin EES			1						1	Erythema; Pruritus; Rash erythematous	FLUN3~MEDIMMUNE VACCINES, INC.~500431P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0264138	10/06/2006	TX	81.0	81		F	10/06/2006	Wake up with rash on abdomen under breast and on neck with itching.				Y					N	10/05/2006	10/05/2006	0		OTH	PUB		NONE	Sulfa			1						1	Pruritus; Rash; Pruritus; Rash; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA202BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0486F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA20281A~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~2|PPV~MERCK & CO. INC.~0486F~1~IM~LA~PNEUMO (PNEUMOVAX)~2|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA202BA~2~~UN~INFLUENZA (SEASONAL) (FLUARIX)~3|PPV~MERCK & CO. INC.~04868F~2~~UN~PNEUMO (PNEUMOVAX)~3	USA	Emergency room visit	Influenza
0264121	10/07/2006	MO	55.0	55		M	10/07/2006	Received Pneumonia and Flu shots at 11:00am on 10-06-06: one in each deltoid. Appx. 2 hours later severe pain, muscle aches, stiffness, and tenderness developed in the left arm where Pneumonia shot was administered. Condition worsened all day and spread to top of shoulder, arm-pit, and neck area. The pain became so intense that the left arm could not be moved or touched. Took a Tylenol before bedtime, which did relieve the pain some. Spent most of the night without sleep. Could not lay on or move left arm. The next morning same symptons but somewhat less severe. Can't raise arm outward (away from body) or overhead. Now 10:00am and pain still intense!									U	10/06/2006	10/06/2006	0		UNK	UNK	Coumadin       5mg Lipitor        10mg Enalapril      5mg Toprol XL      100mg Gemfibrozil    600mg Effexor XR     37.5mg Prevacid       30mg Asprin         81mg		Cornory Disease (3 stents) Hiatial Hernia acid reflux			1						1	Musculoskeletal stiffness; Myalgia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264122	10/07/2006	TN	64.0	64		F	10/07/2006	Ran fever of 102.3 degrees.  Took Tylenol.									Y	10/02/2006	10/05/2006	3		UNK	UNK		None	None			1						1	Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0264123	10/07/2006	WA	53.0	53		M	10/07/2006	Very red, sore, hot reaction over four inches from left arm site of injection. Trouble breathing. Dr said possible infection but three friends had same exact reaction after taking vac from same location.				Y					N	10/04/2006	10/04/2006	0		UNK	UNK	Benadryl	Allergies only				1						1	Dyspnoea; Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0264124	10/08/2006	FL	74.0	74		F	10/08/2006	I got the hives and my husband got Hoarseness									Y	10/04/2006	10/05/2006	1		UNK	UNK		none				1						1	Dysphonia; Urticaria	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0264156	10/09/2006	IL	2.0	2	.5	M	10/06/2006	Hep A 1440 given instead of 720. No reaction as of contact with mother 10/09/06.									Y	10/04/2006				PVT	PVT		Conjunctivitis				1						1	Medication error	FLU3~SANOFI PASTEUR~U2174DA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB109AA~2~IM~LA~HEP A (HAVRIX)~1	USA		Influenza
0264170	10/09/2006	CO	65.0	65		F	10/09/2006	Complained of extreme soreness, redness/rash and warmth at site of injection.   She went to the doctor, was diagnosed with cellulitis and was prescribed cephalexin 500mg QID as treatment.				Y					Y	10/04/2006	10/05/2006	1	Not known	UNK	UNK	LEVOTHYROXINE 75MCG ESTRATEST HS	NONE KNOWN	ALLERGIES TO : Codeine, tetracylines, terfenadine, quinolones, piperidine antihistamines			1						1	Cellulitis; Injection site erythema; Injection site pain; Injection site rash; Injection site reaction; Injection site warmth	FLU3~SANOFI PASTEUR~U2177AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0391F~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0264173	10/09/2006	TX		64		F	10/09/2006	In morning soreness and swelling in right arm by the afternoon (5 pm) had chills lasted for 12 hours, started again afternoon of 10/5 by 1 pm.  Had chills until 10/6.  Had a 4-inch round node by injection site.				Y					Y	10/03/2006	10/04/2006	1		OTH	PVT	PLAVIX, TOPROL, CELEBREX, ZOCOR	NONE	heart attack 3 years ago, cholesterol, arthritis			1						1	Chills; Injection site nodule; Myalgia; Swelling; Chills; Confusional state; Fatigue	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U2218AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0485F~UNK~~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0264174	10/09/2006	UT		53		F	10/09/2006	body aching and chills-malaise.									Y	10/04/2006	10/05/2006	1		PVT	PVT	NONE	NONE	NONE			1						1	Chills; Malaise; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69424~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0486F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264175	10/09/2006	UT		49		M	10/09/2006	Fever, chills, body aches, headache.  Symptoms began with redness and swelling at site of injection.									Y	10/03/2006	10/04/2006	1		PVT	PVT		NONE	NONE			1						1	Chills; Headache; Injection site erythema; Injection site swelling; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69424~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0486F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264176	10/09/2006	TX		75		F	10/09/2006	Redness, swelling (some) and warmness, redness started at top of arm and moved down the arm.									Y	10/06/2006	10/06/2006	0		OTH	UNK		NONE				1						1	Erythema; Injection site warmth; Swelling	FLU3~SANOFI PASTEUR~U2180AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0391F~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264177	10/10/2006	TX	66.0	66		F		Area that received vaccination (left arm) is swollen to the size of hand; hard and warm to touch; hurts when raise arm; Patient has no other medical problems; suggested ALEVE and hydrocortisone cream of which she took and she said will take BENADRYL.  Spoke to the manufacturer of Pneumovax and they suggest going to emergency room, which was relayed to patient per person mentioned.										10/09/2006	10/09/2006	0		OTH	PVT	ALLERGA	NONE	NONE			1						1	Injection site oedema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U2180AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0486F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264197	10/10/2006	PR	43.0	43		M		High blood pressure, lost of memory, depression, hearing loss, appearing warts in my body.									Y	11/02/2003				MIL	MIL	Lisinopril, Uenlafaione HCL, Clonazepam,					1						1	Amnesia; Blood pressure increased; Depression; Hypoacusis; Skin papilloma	ANTH~EMERGENT BIOSOLUTIONS~~UNK~~UN~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~4~~UN~SMALLPOX (DRYVAX)~1	USA		Influenza
0264198	10/10/2006	WI	7.0	7		F	10/02/2006	Red, swollen upper right arm, hives, red streak from site of injection, gave Benadryl.				Y					Y	09/29/2006	09/30/2006	1	Acute sinusitis 9/29/06	PVT	PVT	Augmentin	Acute sinusitis	Immunodeficiency, selective IGA.			1						1	Injection site erythema; Injection site oedema; Sinusitis; Urticaria	FLU3~SANOFI PASTEUR~U2168AA~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0089F~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0264199	10/10/2006	TX	56.0	56		M	09/25/2006	Pt complained of swollen tongue days after vaccine given, pt states no other meds taken or changes in daily routine.									U	09/22/2006	09/23/2006	1		OTH	PVT	Benadryl	NONE				1						1	Tongue oedema	FLU3~SANOFI PASTEUR~U2180AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264200	10/10/2006	MA	55.0	55		F	10/09/2006	Pt reported that the left side of her brain became blocked sometime after receiving Flu vaccine, no exact date given pt would not reveal MD name but MRI and Cat Scan were normal. PT recovered threw the us of every work.									Y	10/27/2005	08/31/2006	308	MRI and Pet Scan of brain normal.	PUB	UNK	Atenolol, HCTZ, Norvasc.	NONE	Essential HTN benign			1						1	Mental impairment	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA142AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0264201	10/10/2006	NC	52.0	51		F	09/27/2006	Immediate swelling and local fever in arm tightness. Pt used ice packs and Ibuprofen (800) during the night. On 9/27 saw Dr prescribed antibiotic and pain mediation.				Y					U	09/26/2006	09/26/2006	0		PUB	PVT					NC06091	1						1	Injection site oedema; Injection site warmth; Musculoskeletal stiffness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70383~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0089F~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0264260	10/10/2006	NJ	54.0	54		M	10/10/2006	24 hours after flu shot got chills and 96.5ºF body temp.  Slept for 4 hours. Awoke with 101.3º body temp.  Spent rest of day and most next day in bed with fever around 101º.  Fever subsided in evening.  Following day body temp back to normal.  Feel fine today...4 days later.									Y	10/06/2006	10/07/2006	1		UNK	UNK	Lipitor, Triamterene					1						1	Chills; Pyrexia	FLUX~UNKNOWN MANUFACTURER~70736~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0264261	10/10/2006	CA	1.33	1	.3	M	10/10/2006	No adverse symptoms at time vaccine was given.  No adverse signs noted at the time the vacine was administered.  No calls from parents to report adverse effects.  .25 cc adult flu vacine given instead of pediatric flu vacine.  This report is being filled out per call to VAERS by supervisor who stated that vacine was not recommended in children under 4 years of age and VAERS report should be completed.									Y	10/06/2006				UNK	UNK	None at this time.	None, child's visit to MD was a preop for hernia repair.				1						1	Medication error	DTAP~SANOFI PASTEUR~C2207AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70384~1~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARCEL~MERCK & CO. INC.~0915F~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0264267	10/10/2006	MI	47.0	47		F	10/10/2006	Complains of a numbness feeling in her right arm, extending from her elbow down to her right index finger on 7 Nov 05.				Y					U	11/05/2005	11/07/2005	2		MIL	MIL	N/A	N/A	NKDA			1						1	Hypoaesthesia	FLU3~SANOFI PASTEUR~U1869AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0264268	10/10/2006	TX	51.0	51		M	10/10/2006	Vaccine given on 10/06/06 at 11:45 AM; flu-like symptoms appeared shortly thereafter and are still present (10/10/06); fever peeked at 102.5F, dizziness, chest discomfort, very weak and hoarse. Medical attention was necessary but unavailable because of weakened atate, not able to drive. Vaccine was given as part of a health clinic.				Y					Y	10/06/2006	10/06/2006	0	N/A	UNK	UNK		None	None			1						1	Asthenia; Chest discomfort; Dizziness; Dysphonia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0264269	10/10/2006	VA	31.0	31		F	10/10/2006	Administered Flumist vaccine at 1245-1300. Pt felt sleepy, tongue heavy and palpitations within 1 hour of administration.				Y					Y	10/10/2006	10/10/2006	0		MIL	MIL		Hypothyroidism	none			1						1	Palpitations; Somnolence; Tongue disorder	FLUN3~MEDIMMUNE VACCINES, INC.~500429P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0264274	10/10/2006	TX	41.0	41		M	10/10/2006	This case was reported by a pharmacist and described the occurrence of feeling of pressure in legs in a 41 year old male subject who was vaccinated with Fluarix for prophylaxis. The subject had no adverse events following receipt of prior immunizations of Influenza (unspecified manufacturer). On 9/28/06 the subject received a dose of Fluarix in the right arm. On 10/1/06, 3 days after vaccination with Fluarix, the subject experienced feeling of pressure, heat and discomfort from his knees to his feet. The pharmacist considered the events to be clinically significant (or to require intervention) (OMIC). The subject was seen by his physician and referred to a neurologist. At the time of initial reporting, 10/9/06, the event were ongoing.				Y					N	09/28/2006	10/01/2006	3		OTH	PVT					A0622827A	1						1	Discomfort; Feeling hot; Limb discomfort; Sensation of pressure	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA202BA~UNK~~LL~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0264276	10/10/2006	IN	1.0	1	.0	M	10/10/2006	Developed 102 temp lasting 36-48 hours. Developed about 3x2.5 inch red, raised area on right thigh. Also developed hives on right lower leg and abdomen. Hard 1.5 inch diameter area wider red area. Phoned nurse who administered vaccines. Says HIB and Hep A given in right thigh.									Y	10/05/2006	10/06/2006	1	NONE	PVT	UNK		URI	RAD			1						1	Injection site erythema; Injection site induration; Injection site swelling; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U2202AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB124AA~1~IM~RL~HEP A (HAVRIX)~1|HIBV~MERCK & CO. INC.~0276F~3~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08691H~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0264277	10/10/2006	OH	66.0	66		M	10/10/2006	Patient felt discomfort in left arm approximately 2 hours after vaccine. Subdermal bleeding due to Warfarin use with excessive swelling and bruising.				Y					Y	10/05/2006	10/05/2006	0		OTH	PUB		NONE				1						1	Contusion; Discomfort; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA202AA~4~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0264278	10/10/2006	IL	0.5			F	10/10/2006	Given .25cc of Fluvirin vaccine.									U	10/10/2006				OTH	UNK		NONE	NONE			1						1	Medication error	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0263678	10/11/2006	TX	24.0	23		M	10/04/2006	09/22/06 flu like symptoms after smallpox injection 9/19/06, headache, body aches, blood streaked emesis diarrhea, rash developed on back ant right shoulder and pruritis. Chest + papular rash, pustules. D/C to quarters x 24 hours, Motrin, Tylenol T 98.7.				Y					Y	09/14/2006	09/22/2006	8	NONE	MIL	MIL	Motrin/Tylenol	UNK	UNK			1						2	Blister; Injection site vesicles; Diarrhoea; Haematemesis; Headache; Influenza like illness; Pain; Pruritus; Rash papular; Rash pustular	SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1|ANTH~EMERGENT BIOSOLUTIONS~FAV103~UNK~IM~UN~ANTHRAX (BIOTHRAX)~2|FLUN3~MEDIMMUNE VACCINES, INC.~5004284P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB061AA~UNK~IM~UN~HEP A + HEP B (TWINRIX)~2|SMALL~PFIZER\WYETH~4020072~UNK~SC~UN~SMALLPOX (DRYVAX)~2	USA	Emergency room visit	Influenza
0264299	10/11/2006	SC	68.0	67		M	10/11/2006	Left upper arm pain and tenderness, fever, elevated WBC count.				Y					U	10/10/2006	10/10/2006	0	CBC	PVT	PVT						1						1	Injection site pain; Pyrexia; Tenderness; White blood cell count increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70618~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1007P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0264300	10/11/2006	CA		72		M	10/09/2006	10/5, rash on arm, 10/6, pain in left kidney area, rash extended from injection site to elbow, very hot. Trouble urinating. Seen by doctor the the afternoon and started on treatment with Keflex (4 X/day). Tylenol for pain and warm/moist compresses. Rash almost gone today. Pain in kidney area continues. Relief of medication only lasts 4-6 hours.				Y					N	10/04/2006	10/05/2006	1		OTH	PUB	Levothyroxine; Enalapril; Lasix (furosemide); vitamin C and E, Owvite with lutein; ///	NONE	Hypothyroid; high blood pressure; cerebral hemorrhage (in 1988) shunt.			1						1	Injection site rash; Injection site warmth; Renal pain; Urinary retention	FLUX~UNKNOWN MANUFACTURER~02186AA~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0391F~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0264301	10/11/2006	TX	30.0	29		F	10/09/2006	High fever, ache (body) difficult breathing, tightness in chest, headache, coughing, sharp chest pain, fatigue, burned vision.									Y	10/06/2006				PUB	OTH	Zyrtec D		Sinus infection 9/25/06			1						1	Chest discomfort; Chest pain; Cough; Dyspnoea; Fatigue; Headache; Pain; Pyrexia; Vision blurred	FLU3~SANOFI PASTEUR~U2180AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264303	10/11/2006	NC	21.0	21		M	09/12/2006	21 year old male presented to ER with local reaction to smallpox vaccine, had smallpox shot a wk ago. When going to bed noted area raised and painful with red strip on upper arm with red streak to axilla. Given Toradol 60 mg IM in ER. Wound dressed, sent home, F/U in am.				Y					Y	08/24/2006	09/03/2006	10	HIV	MIL	MIL	Naproxin	NONE	NONE			1						1	Erythema; Injection site erythema; Injection site pain; Injection site swelling	FLUN3~MEDIMMUNE VACCINES, INC.~500429P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~PFIZER\WYETH~4002072~1~~RA~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0264305	10/11/2006	PA	6.0	5		M	10/03/2006	Right arm swollen, slightly erythematous and tender.				Y					U	10/02/2006	10/03/2006	1		PVT	PVT	NONE	NONE	Dry mold, peanuts, dogs, ? eggs.			1						1	Erythema; Oedema; Tenderness	FLU3~SANOFI PASTEUR~U2168AA~4~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0264308	10/11/2006	RI	74.0	74		F	10/03/2006	Pt complained of headache 5 min after injections. Placed pt on left side SXS within normal limit. Headache after 15 min. Pt remained on left side for additional 15 min. SXS continued within normal limit called pt at 4:00 pm husband stated she is out driving and feels fine.									Y	10/03/2006	10/03/2006	0		PUB	UNK						1						1	Headache	FLU3~SANOFI PASTEUR~U2256AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1036P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264309	10/11/2006	CA	40.0	40		F	10/03/2006	4 hours after injection given pt developed fever 101 right arm, red sore arm, swelling in shoulder arm. She went to the ER SC with type 4 reaction to protein in the vaccine. Pt and nausea, declined pain and and nausea meds. As of 10/06/06 pt still has pain and is not able to have full ROM of arm and shoulder. Is followed by PCP. RXN in right arm Pneumovax in right deltoid.				Y					N	09/29/2006	09/29/2006	0		PVT	PVT		NONE	All compazine, morphine, codeine, sulfa.			1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site reaction; Joint range of motion decreased; Nausea; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69424~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0486F~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0264311	10/11/2006	LA	44.0	43		F	10/03/2006	None Stated									Y	10/02/2006	10/03/2006	1		OTH	PVT						1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69480~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0003F~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264312	10/11/2006	TX	46.0	45		F	10/04/2006	Hoarse voice, voice strangled, coughing frequently, throat not clearing, itching palms, head, arms and legs, inside body, tight air way, no wheezing. BP 115/67, HR 74. Refused to go to ED took 50 mg PO Benadryl. S/S subsided within 1 hour.									Y	10/04/2006	10/04/2006	0		OTH	OTH	Tylenol, Advil.		Dermatitis 2002 etiology unk, altered sensorium.			1						1	Cough; Dysphonia; Pruritus; Throat tightness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70277~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0264399	10/11/2006	IA	60.0	60		M	10/11/2006	High fever, severe muscle and body as a whole aches, night sweats, chills.  Full scale flu-like symptoms excepting respiratory.									Y	10/10/2006	10/10/2006	0	none	UNK	UNK	lisinopril, hydrochlorothiazide, norvasc	none	none			1						1	Chills; Influenza like illness; Myalgia; Night sweats; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264400	10/11/2006	GA	31.0	31		F	10/11/2006	Reported on 10/10/06 that she had seizure (absence of reality) approximately one hour after having had vaccines of MMR and Fluzone. States she has had controlled seizure disorder on Depakote and has only had one other seizure episode.  She has had MMR and Td previously on the same day without problems. She stated she took Benadryl and then slept. She stated the following morning she awoke feeling much better. Has scheduled appt. with neurologist on 10/12/06 for regular annual visit.									Y	10/06/2006	10/06/2006	0	None	UNK	UNK	Depakote ER 500mg 1 daily. Daily Vitamins and Calcium Depo Provera 150mg q 3 mo.	None				1						1	Convulsion	FLU3~SANOFI PASTEUR~U2275AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1053R~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0264402	10/11/2006	NC	84.0	84		F	10/11/2006	Patient developed an immediate swelling at site of injection.  She did not report discomfort, just some stiffness.  Observed for 30 minutes, then patient felt jittery.  Observed for another 20 minutes and took a BP reading, which was 196/113.  Patient reported uncontrolled BP for the past week. Administered 25 mg diphenhydramine PO.  Swelling began to subside.									Y	10/10/2006	10/10/2006	0	none	UNK	UNK	TOPROL, LOTREL, NAPROXEN	HYPERTENSION	HYPERTENSION			1						1	Feeling jittery; Injection site swelling; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U1286AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264404	10/11/2006	VA	41.0	41		M	10/11/2006	Received IM Influenza vaccine 31 Oct 2003 to right deltoid w/mass and tenderness to site area. Approximately 01 Nov 2003 he noted slt tender mass rt supraclavicular area. Denies dental procedure, fever, chills, n/v, shortness of breath, cough, sore throat, dysphagia, smoking. DID have hx abd pain, loose stool prior to vac. HX HTN, lipomas, migraines. Seen by Surgery clinic and Occ health with dx enlarged rt supraclavicular node, poss hilar adenopathy rt upper lung field  11 Oct 2006: 1 Node still present @ 1/2-1cm size, mobile to mid subclavicular nodal region; mobile and non-tender.				Y					Y	10/31/2003	11/01/2003	1	Exam: supraclavicular node rt @2cm firm but mobile, superficial, no erythema or edema: CXR cannot exclude hilar adenopathy on rt upper lung field, with neg exam per surgeon now size at 1cm one day later. CBC wnl	MIL	MIL	Lisopril, HCTZ and vit in 2003 now changed	denies	HTN since 2000 Skin mole removal in 2003 discoid lupus in 2006 migraine  HX PCN allergies			1						1	Injection site mass; Injection site pain; Skin nodule	FLU3~PFIZER\WYETH~~UNK~SC~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0264405	10/11/2006	NY	4.0	4		F	10/11/2006	48 hours after vaccination, mother noticed edema and erythema at the vaccination site (left leg). No fever.									Y	10/06/2006				UNK	UNK		none	Polyviflor			1						1	Injection site erythema; Injection site swelling	DTAP~SANOFI PASTEUR~c2498aa~5~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~u2195aa~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~z0018~4~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0699f~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0264407	10/11/2006	OH	42.0	42		F	10/11/2006	Received flu vaccine on 10/11 at 11:45am in employee health. received in right upper arm. developed numbness in right arm and fingers. then developed numbness in face with right side being greater than left several minutes after injection. right eye began to twitch for 30 minutes. pressure around right eye. numbness started to subside in about one hour but fingers and right side of face, especially under right eye, continues to feel numb and tingly. face and fingers remain to feel slightly numb and tingling several hours later. pressure continues around right eye with numbness under right eye several hours post injection.									N	10/11/2006	10/11/2006	0	none. told by employee health that this would go away and that they had never heard of anything like this.	UNK	UNK	synthroid, toprol xl, proventil solution hhn, azmacort, pepcid.	recoving from ur cold.	asthma, allergies, hypothyroidism, heart arrhythmia.  allergies: codeine, cephalosporins, sulfa			1						1	Hypoaesthesia; Muscle twitching; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~unknown~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0264411	10/11/2006	WA	47.0	47		F	10/11/2006	Fever of 101.8, moderate muscle ache over entire body, headache, chills, red eyes (with some white-ish discharge), racing heart beat, swelling of face, fingers, injection site soreness, sore throat. Symptoms were extreme enough to force bed rest. Took Ibuprofen which eased the symptoms.  Most symptoms were gone by following morning except injection site soreness.									Y	10/10/2006	10/10/2006	0	None	UNK	UNK		None	None			1						1	Chills; Eye discharge; Face oedema; Headache; Heart rate increased; Injection site pain; Myalgia; Ocular hyperaemia; Oedema peripheral; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~2186AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264413	10/11/2006	CA	54.0	54		F	10/11/2006	On 10/11/2006 at approximately 08:30 a.m, the above named employee received the Inactivated Influenza Vaccine (Right Deltoid) and a PPD SKIN Test (Left Arm).  She states that approx. 1 hour post vaccination she developed on LUE fine raised red rash on the LUE spreading to BUE's and back. Other symptoms include generalized pruritis.  Denies respiratory symptoms, Chest pains, or SOB at time of report.   10/11/06 Approx.12:00 Noon:  The employee  report that she recieved a Cortisone Injection from her treating physician for a plantar fascitis problem.  10/11/06 @ 16:30:  The employee presented to the Employee Health Office to report a possible vaccine adverse reaction to the flu shot based on the above symptomology reported.   - Employee self medicated with 2 Benadryl   (50mg total) with little relief at time of report.   -Employeee reports a history of multiple medical conditions.   -Denies adverse reactions with previous Flu vaccine given in 2005. - Employee was referred for further medial evaluation.				Y					Y	10/11/2006	10/11/2006	0	Employee was referred for further Medical Evaluation	UNK	UNK	10/11/06:Cortisone injection in foot;PPD TST Macrodantin (UTI)x1wk Salagen X 5yrs;Tramadol X 27mos Tylenol PRN Pain	No contraindication to vaccine reported.	Arthritis, Fibromyalgia, Sojren Syndrome, Plantar Fascitis, Carpal Tunnel Both Hands, Hx of neck and Back Surgeries			1						1	Pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~U2240AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0264414	10/11/2006	TX				F	10/11/2006	Fever, chills, swollen around injection Tylenol.									U	10/09/2006	10/10/2006	1		OTH	OTH		NONE				1						1	Chills; Injection site oedema; Pyrexia	FLU3~SANOFI PASTEUR~U2180AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0391F~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264415	10/11/2006	GA	59.0	59		F	10/11/2006	5 hrs after receiving vaccine, pt experienced large reaction with red itchy raised lesion, followed by generalized itching (esp of scalp), fatigue, unarousable sleep for over 8 hours, hang over in am, Headache, nausea and muscle aches.									Y	10/10/2006	10/10/2006	0	NONE	PVT	PVT		NONE	Benadryl, Codeine, HCTZ, Sulfa			1						1	Depressed level of consciousness; Erythema; Fatigue; Hangover; Headache; Injection site swelling; Myalgia; Nausea; Pruritus; Skin ulcer	FLU3~SANOFI PASTEUR~U2238AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264416	10/11/2006	CA	64.0	63		F	10/11/2006	The pt had an injection site reaction a red band went around her arm and she had a rash in her armpit. Also she had flu like reaction for 12 hrs (this was right arm), she took Benadryl and was fine her husband is MD.									Y	10/09/2006	10/09/2006	0	NONE	OTH	OTH	UNK	NONE	UNK			1						1	Influenza like illness; Injection site erythema; Rash	FLU3~SANOFI PASTEUR~U2240AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1036P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264429	10/12/2006	TX	42.0	42		F	10/10/2006	Red, swollen, warm to touch (area around injection site).									U	10/07/2006	10/08/2006	1		OTH	PVT		NONE				1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U2180AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0391F~4~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264430	10/12/2006	NC	81.0	80		F	10/06/2006	Pt received flu vaccine in RD IM on 10/02/06. Right arm sore since then. Advised pt to put ice on it and take Tylenol. Go to private DR if not better. Pt to call Dr today.									U	10/02/2006	10/02/2006	0		UNK	UNK	Paxil, MUT, Tylenol.					1						1	Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69480~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0264445	10/12/2006	VA	46.0	46		F	10/12/2006	Initially, I experienced only the expected side effects of the vaccine (e.g., slight discomfort at the location of the vaccine, slight achiness).  However, approx. 8 hours later, I began to experience significant pain in my arms and additional pain (not as severe) throughout my entire upper body.  The pain was so severe in the arms, that I was unable to lift them above my waist.  My neck was also quite stiff (it hurt to move it and I had a pounding headache.  Shortly thereafter I became nauseous, got freezing cold and began to shake uncontrollably.  The shaking continued on and off for about 45 minutes, but the movement from very cold to very hot, nausea, stiffness and headache continued throughout the night.  I was also unable to sleep.    The following day, I was still unable to move my arms without extreme discomfort and remained nauseous, fatigued and feverish through out the day.  By the second day after the shot, movement in my arms was restored, but the nausea and fatique continued, although to a lesser degree.  It is now the third day after the shot and the only remaining symptoms are slight achiness, nausea and soreness at the injection site (i.e., the expected symptoms).  I should note 3 facts:  (1) I had received the vaccine without incident approx. 5 1/2 years prior to this injection;  (2) I received the flu shot at the same time; (3) I had an allergy shot the prior Monday (could not find this listed in the pull down menu in no. 14)									N	10/09/2006	10/09/2006	0	n/a	UNK	UNK	Advair (100/50); Singular (10 mg daily); Combivent (2 puffs, 2x per day); allergy shots; Ortho Trycyclen Low; Prozac (15 mg daily); Wellbutrin (150 mg daily)	n/a	enivornmental allergies; asthma; copd (bronchitis)			1						1	Chills; Discomfort; Fatigue; Headache; Hot flush; Hypokinesia; Injection site pain; Musculoskeletal stiffness; Nausea; Pain; Pyrexia; Sleep disorder; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0264451	10/12/2006	FL	32.0	32		F	10/12/2006	ON OCT. 3RD INFLUENZA VACCINE WAS ADMINISTERED FIRST TIME RECEIVING VACCINE.  OCT. 4TH EMPLOYEE CALLED THE IMMUNIZATION CLERK C/O SWELLING IN HER FACE. EMPLOYEE TOOK ZYRTEC FOR ALLERIES.  ON OCT. 11TH SWELLING WAS GOING INTO HER NECK AND SHE WENT TO THE DOCTOR.				Y					N	10/03/2006	10/04/2006	1	EMPLOYEE WENT TO WORKMANS COMP. PHYSICIAN ON OCT. 11TH.	UNK	UNK	EMPLOYEE TOOK LAST DOSE OK ANTIBIOTIC FOR RECENT UTI THE DAY BEFORE VACCINE.	OCT. 4TH C/O TOOTH SWELLING AND GUM SWELLING THEN KNOT IN NECK THE NEXT DAY.	EMPLOYEE HAS SEASONAL ALLERIES, HX. OF COLONOSCOPY ON OCT. 2ND. ON OCT. 4TH C/O SWELLING AROUND HER TOOTH THEN NEXT DAY KNOT IN HER NECK AND GUM SWELLING MORE.			1						1	Face oedema	FLU3~SANOFI PASTEUR~U2178AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0264456	10/12/2006	CA	75.0	74		F	10/02/2006	Asthma attack, muscle soreness and fever.									Y	09/26/2006	09/26/2006	0		OTH	PVT		NONE				1						1	Asthma; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U2240AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264466	10/13/2006	IN	1.02	1	.0	M	10/06/2006	Fever listless/lethargic: opisthotonus nuthal rifiche petechiae neck and arm where tourniquet was.  No local reaction to shots.  10/27/06 Received medical records from second hospital which revealed patient was seen in ER on 10/5 & experienced fever (102.2 ax), lethargy & decreased appetite.  Had been seen by PCP on 10/5 & LP was done in office & sent to first hospital. Transferred to second hospital to r/o sepsis. Petecchaie noted on neck & face & initial physician noted opisthotonos & nuchal rigidity.  Final dx: febrile reaction to immunizations. 10/31/06 Received medical records from first hospital which reveal patient admitted 10/5/06 with fever & listlessness.  Presentation was limp, pale, irritable with stiff neck & fever of 101.8ax s/p vax day before. 11/13/06 Received medical record from PCP for office visit 10/4/06 day of vax which revealed patient was healthy with only redundant foreskin noted as health concern & was referred to urologist./ss					Y				Y	10/04/2006	10/05/2006	1	LABS: in PCP office 10/5 showed WBC 14.6, granulo 74%, 26% lymphs & monos.  plt ct 391,000.  Hgb 12.2.  UA neg. LP done & was neg.  All cultures neg./ss LABS from second ER: WBC 10.94, neutros 57, lymphs 35, eos 0.4, bands 21.  CT scan of heal was WNL with mild mucosal thickening in right maxillary & right ethmoid sinus./ss	PVT	PVT						1						1	Lethargy; Listless; Opisthotonus; Pallor; Petechiae; Pyrexia; Vaccination complication	FLU3~SANOFI PASTEUR~U2257AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~0826F~1~~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08691F~4~~LL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0264471	10/13/2006	PA	5.0	5		F	10/10/2006	Redness, swelling and pain at sight of injection ((L) arm).									Y	10/07/2006	10/08/2006	1		PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site pain; Injection site swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B040AA~UNK~~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2256AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1032~UNK~~RA~POLIO VIRUS, INACT. (POLIOVAX)~1|MMRV~MERCK & CO. INC.~0973F~UNK~~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0264472	10/13/2006	MI	61.0	61		F	10/03/2006	Pt complained that she couldn't lift or use arm the next day. Went to MD and recommended ice and pain pills for a few days and scheduled ultrasound of arm.				Y					N	09/28/2006	09/29/2006	1		OTH	OTH	Vicodin for pain	NONE	NONE			1						1	Injection site pain; Joint range of motion decreased	FLU3~SANOFI PASTEUR~U2256AA~7+~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0264483	10/13/2006	CA	30.0	30		M	10/13/2006	Developed bilateral axillary lymphadenopathy 2 days post vaccination started having fever 3 days after vaccination. Worsening tenderness in axillary lymphadenopathy on day 5 post vaccination.									N	10/05/2006	10/07/2006	2	EKG non specific Q waves in AVF, No ST changes.	MIL	MIL			Seasonal allergic rhinitis.			1						1	Lymphadenopathy; Pyrexia; Tenderness	ANTH~EMERGENT BIOSOLUTIONS~FAV102~7+~SC~UN~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500430P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~PFIZER\WYETH~4020076~2~~~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~Z0925~4~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0264484	10/13/2006	NC	59.0	59		F	10/13/2006	got the shot at 10:45 am. it was administered in my right deltoid. felt fine when i went to sleep about 10p. woke up at approx 2am with very sore throat (right side) and very sore right ear. the ear pain subsided for the most part on 10-12 and as of today 10-13 the pain in both my throat and ear have greatly lessened but is still noticable. on 10-12 i was so weak that i spent most of the day in bed sleeping. i continue to feel weak today, but not as weak as yesterday.									U	10/09/2006	10/10/2006	1	if i am not completely recovered by 10-16 i will go to the dr.	UNK	UNK	actonel 5mg lorazepam 1 and 1/2 mg remeron 7 mg		gad_(generalized anxiety disorder)	~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Asthenia; Ear pain; Pharyngolaryngeal pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70736~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0264488	10/13/2006	LA	73.0	73		F	10/13/2006	Area of right deltoid shows redness with erythmea, patient instructs very pain and warm to touch, instructed to apply cold compresses to site, use Benadryl and prescription of pain medication given if needed.				Y					U	10/12/2006	10/12/2006	0	none	UNK	UNK	Clonidine .2mg qd, Zyrtec 10mg qd, Norvasc 10mg qd, Synthroid 100micrograms qd, Ditropan XL 10mg qd, HCTZ 25mg qd, Alprazolam .25mg Q6H prn, Tamoxifen 20mg qd, Premarin vaginal cream, Wellbutrin 150mg qd	None	HTN, Hypothyroidism, obesity, depression, incontinence, h/o breast cancer, menopausal			1						1	Erythema; Injection site warmth; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71213~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0003F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0264490	10/13/2006	GA	35.0	35		F	10/13/2006	Received flu shot at 2:00 at work (free flu shots); this was my first flu shot ever. Throat started getting scratchy at about 4:00. Throat started tightening and started wheezing by 6:00.  One eye felt dried out.  By 8:00 had severe body aches, difficulty breathing, eyes red & puffy, bad headache.  Took inhaler (I have mild allergy to cats) to help with breathing, and took ibuproferin.  Told husband to keep an eye on me & went to bed.  Besides a slight headache & mild body aches, I felt better in the morning. I have not visited an emergency room since I was 5 yrs old and I seriously considered going that evening.									Y	11/03/2005	11/03/2005	0		UNK	UNK	None	None	mild asthma requiring occasional use of inhaler			1						1	Dry eye; Dyspnoea; Eye swelling; Headache; Ocular hyperaemia; Pain; Pharyngolaryngeal pain; Throat tightness; Wheezing	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0264511	10/13/2006	TX	50.0	50		F	10/13/2006	Pt said that she slept most of today, but woke up this afternoon with left arm swollen to elbow, hot to the touch and painful. She said she could lift arm and that swelling has not worsened since she woke up. I advised her to continue her anti inflammatory medicine, take a couple of Benadryl and to place cold compress on left arm. I also advised her to have a family member or friend with her over next few hours and to contact doctor or go to ER if swelling worsens or dose not get better by the next day.									Y	10/12/2006	10/13/2006	1		OTH	PVT	Spiriva, Ditropan XL, Albuterol, Lisinopril, Prevacid, Zoloft, Vytorin, Lidoderm, Tizanidine, Mobile, Ambien.	NONE	Allergy Tetracycline.			1						1	Injection site oedema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U2180AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0391F~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264513	10/13/2006	TN	56.0	55		F	10/13/2006	Pt called c/o top lip swollen 3 hrs post injection. Pharmacist advised 50 mg Benadryl if no improvement go to ER.									U	10/13/2006	10/13/2006	0		UNK	UNK						1						1	Face oedema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71215~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0264515	10/13/2006	IL	83.0	82		M	10/13/2006	10/12/06 15:08 pt began to c/o left arm and neck pain after immunization, difficulty breathing, color became dusky appeared to have trouble catching breath, O2 at 9L per face mask applied Benadryl 50 mg/ml administered 15:09, Dr paged, 1510 pt c/o chest pain Nitro stat 0.4mg administered sublingually pulse oximeter @ 98% HR 89, BP 150/96, HR 82 15:30 EKG started, pt feeling better as stated by him, chest pain resolved, breathing normally, HR 82 pulse ox 97%, color pink.									Y	10/12/2006	10/12/2006	0	EKG, pulse oximetry.	PVT	PVT			Allergic to sulfa, COPD, colon cancer, Meningioma, CAD, OA, A Feb, CHF, IC Hemorrhage.			1						1	Chest pain; Cyanosis; Dyspnoea; Hypoxia; Injection site pain; Neck pain	FLU3~SANOFI PASTEUR~U2239AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264517	10/13/2006	DC	7.0	7		F		Bell's Palsy Developed 3 days after being given Flu mist in my office, symptoms 95% resolved in 6 days from onset. 10/16/06 Received medical records from PCP which reveal patient on track developmentally on 6/8/06 visit.  Received FluMist on 10/4/06.  On 10/6 had difficulty visualizing at school with right eye.  On 10/9/06 noted to have 2 days of erythematous right infra orbital area with slight facial asymmetry which increased on 10/8 & was taken to ER.  Labs & CT scan were reported as WNL. ER started patient on antibiotics, antivirals & steroids with improvement noted on 10/9 office visit.  Dx: Bells Palsy, r/o Lyme, virus & AE to FluMist.  Right eye was patched for protection.  Seen again on 10/13/06.  continued on same meds.  Was much improved: frown symmetrical & smile only slightly asymmetrical.  Able to close both eyelids tightly. Dx: Idiopathic Bells Palsy, almost completely resolved. 12/7/06 Received medical records from hospital which patient seen in ER on 10/8 w/right facial paralysis since 10/7.  Tx w/antibiotics, antiviral & steroids. CT scan of head was WNL.  Only lab included in records was partial CBC which was WNL.				Y					Y	10/04/2006	10/07/2006	3	Lyme Disease Western Polot neg LABS: ESR elevated at 30, WBC 8.1.  Lyme IgM antibodies positive./ss	PVT	PVT	NONE	Fatigue for a few weeks	NONE			1						1	Erythema; Facial palsy; Visual disturbance	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0264518	10/13/2006	GA	65.0	65		F	10/13/2006	Fever, large area of erythema, 8x3, unable to use rt arm to get out of chair.									Y	10/06/2006	10/07/2006	1	NONE	PVT	PVT		NONE	Allergic to Penicillin, sulfa, Ibuprophen, naproxyn, corgard, Erythromycin, Lavaxyl			1						1	Erythema; Hypokinesia; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70249~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0320F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264519	10/13/2006	GA	61.0	60		M	10/13/2006	Fever, pain, erythema of skin on right upper arm, swelling of right upper arm.									Y	10/06/2006	10/07/2006	1	NONE	PVT	PVT	Lantus, Flonase, Advair, Albuterol, Ibuprofen, Lipitor, Glucophage, Gluoctrol	NONE	No allergies, COPD, osteoarthritis, DM II, allergic rhinitis.			1						1	Injection site erythema; Injection site oedema; Injection site pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70249~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0320F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264520	10/13/2006	CO	40.0	39		F	10/13/2006	Approx 5 minutes after administration pt complained of racing heart, nausea, tingling fingers, and clamminess. Her breathing was not labored, and blood pressure was 138/78 with pulse of 90. 911 was called. Paramedics arrived and checked her out. Her blood pressure normalized to 118 over 70. Paramedics advised her to go to hospital, but did not take her in the ambulance. Reaction was suspect to be anxiety/adrenalin reaction. Pt then left the store.									Y	10/12/2006	10/12/2006	0		OTH	PVT						1						1	Anxiety; Blood pressure increased; Cold sweat; Heart rate increased; Nausea; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71033~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0264521	10/13/2006	MS	19.0	19		F	10/13/2006	RN gave shot at 2:45 pm, pt went to work at 3:00, began to notice chest getting tight and SOB. Pt told other staff who passed it off. One employee told he to contact RN at 3:48 was reported to RN. RN told her to get to her employee Nurse office where she work. PT looked okay no rash not cyanotic, but pt said chest felt tight and she couldn't breath, Rn took her to ER at 3:50 (where she works). The gave Xopenex breathing treatment 3:55 and IV Solumedrol 125 mg at 3:50. They watched her gave her a prescription for Medrol dose pack. Pt went home at 5:00pm released into care of aunt who is LPN (works at hospital too), Pt said she was fine when she left, no chest tightness, no SOB. RN told her to never take a flu shot again. Pt mother was deceased about 1 month ago Others said PT RN did not believe it to be from cancer.				Y					Y	10/12/2006	10/12/2006	0	O2 Sat normal	PUB	PVT	Birth Control Pills		Seizures in the past.			1						1	Chest discomfort; Dyspnoea	FLU3~SANOFI PASTEUR~U2165CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0264496	10/14/2006	TX	80.0	80		M	10/14/2006	Dizziness (vertigo) and  moderately severe fatigue beginning approximately 10 minutes after influenza immunization. More severe by suppertime. Could not stand. Severe the following day. Gradually improved. Immunized Oct. 9,2006. Mild residual symptoms Oct. 14.									N	10/09/2006	10/09/2006	0		UNK	UNK	pravastatin 20 mg daily	none	yellow dye no.5, aspirin, penicillin, tetracycline, sulfa			1						1	Dizziness; Fatigue; Hypokinesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0264497	10/14/2006	PA	3.0	3		M	10/14/2006	HAD VACCINE YESTERDAY AFTERNOON. IN EVENING NOT FEELING WELL AND BECOMING VERY PALE. IN MORNING WOKE UP AT 7 AM VOMITING AND VERY PALE. COMPLAINING ABOUT DIZZINESS, BAD VISION AND VOMITING A LOT THROUGHOUT DAY! MOSTLY VOMITING CLEAR FLUIDS. NOT REPORTED TO PEDEATRICIAN AS IT IS WEEKEND. FATHER MD HIMSELF AND TREATING PATIENT.									N	10/13/2006	10/13/2006	0		UNK	UNK		NONE	ASTHMA, ALLERGIES TO POLLENS E.G. BIRCH ALLERGIC TO PEANUTS, TREE NUTS, SESAME SEEDS, SHELLFISH			1						1	Dizziness; Malaise; Pallor; Visual disturbance; Vomiting	FLUX~UNKNOWN MANUFACTURER~~4~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0264501	10/15/2006	WA	42.0	42		F	10/15/2006	Shortly after the vaccination my arm began to hurt, in my opinion, above average for this vaccination which I've had before. Then within a few hours I began to feel sick and got hives on my face, head and chest. I itched alot. No shortness of breath was noted or breathing problems.  Some dizziness the next day (today).									Y	10/14/2006	10/14/2006	0		UNK	UNK		No	Asthma, possible rheumatoid arthritis			1						1	Dizziness; Malaise; Pain; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0263519	10/16/2006	DC	65.0	65		F	10/10/2006	Information has been received from a 65 year old female who is a physician with asthma and penicillin and aspirin allergies, who on 9/22/06 was vaccinated SB in the right arm with a 0.65 ml dose of varicella zoster virus vaccine live. Concomitant vaccination (given in the same arm about 3 inches away from the site of varicella zoster) included a dose of influenza virus vaccine (unspecified). Other concomitant medications included Advair, and Allegra. On 9/23/06 the pt experienced a severe localized reaction on her right arm including erythema, pain/tenderness, swelling, pruritis and warmth. It was reported that the reactions appeared within 24 hours after the injection. At the time of the report, 9/25/06, the pt still had the symptoms. NO product quality complaint was involved. Additional information has been requested.									N	09/22/2006	09/23/2006	1	NONE	OTH	OTH	Allegra, Advair, Singulair		Asthma, penicillin allergy, drug hypersensitivity.		WAES0609USA05953	1						2	Injection site erythema; Injection site hypersensitivity; Injection site pain; Injection site swelling; Injection site warmth; Pruritus; Sleep disorder; Injection site erythema; Injection site hypersensitivity; Injection site oedema; Injection site pain; Injection site warmth; Pruritus; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1|TD~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~~TD ADSORBED (DITANRIX)~1|VARZOS~MERCK & CO. INC.~~UNK~SC~~ZOSTER LIVE (ZOSTAVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|VARZOS~MERCK & CO. INC.~0622f~UNK~SC~UN~ZOSTER LIVE (ZOSTAVAX)~2	USA		Influenza
0264512	10/16/2006	TX	65.0	65		M	10/13/2006	Swelling at site of injection.  Doctor said possible infection.									U	10/11/2006	10/12/2006	1		OTH	UNK						1						1	Injection site swelling	FLU3~SANOFI PASTEUR~U2180AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0391F~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264539	10/16/2006	TX	51.0	50		F	10/11/2006	Initial report received on 10/3/06 from a health care professional. A 50 year old female pt, with an allergy to Vicodin and Penicillin, had received a left deltoid dose of Fluzone SV 2006-2007 USP, lot number U2192AA, on 10/3/06. The route of administration was not reported. The pt experienced a sudden onset of itching and rash at the injection site on 10/3/06. She required medical evaluation and was treated with Solu Medrol and Zyrtec. The recovery status of the pt was reported as unk. The reporter for this case is the same as for case 200602586. (OMIC)				Y					U	10/03/2006	10/03/2006	0		UNK	UNK			It was unknown if the patient had any illnesses, or was using any other medications at the time of the vaccination on 03/Oct/2006.  The patient is allergic to Vicodin and Penicillin.  It was unknown if the patient had received any other vaccination within four weeks of the vaccination on 03/Oct/2006.		200602585	1						1	Injection site hypersensitivity; Pruritus; Rash pruritic	FLU3~SANOFI PASTEUR~U2192AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0264540	10/16/2006	TN	12.0	12		F	10/04/2006	Serious post marketed study vase from a Nurse of chest pain considered medically important.  The reporter causality is possible top Flu Mist.  This is a case involving a 12-year-old female patient with unknown medical history who received Flu Mist VACCINATION ON 03oCT06.  Ten minutes after receiving Flu Mist, this patient returned to the clinic complaining of not feeling right.  According to the nurse who was present at the clinic, the patient exhibited diaphoresis and rapid respiration.  Patient's pulse rate was over 150 (sitting) and patient began to complain of having chest pain (supine).  There were no complaints of shortness of breath, radiation of pain, nausea or vomiting, dizziness, anxiety, or loss of consciousness.  Paramedics were called and the patient's blood pressure (160/80, no baseline BP available) was taken.  As the patient was waiting for an ambulance, she complained that he throat felt funny.  After clearing her throat,the patient indicated that the throat symptom had completed dissipated.  The paramedics and the patient's father arrived at the scene five minutes later and the patient was taken to the emergency room.  The reporter denies that the patient was on any medications, including aspririn-containing therapy, prior to Flu Mist vaccination.  The patient's father denies this patient having any allergies or hypersensitivity to eggs or egg products.  According to the reporter, however, there is a history of patient hospitalization about a year ago for stomach problems.  The patient was told by the hospital not to eat eggs, corns and wheat.  The outcome of the events is unknown at this time.  A request was made to the reporter to forward all relevant follow up medical documentation's obtained on this patient to Product Safety.  The investigator causality is possible to Flu Mist. (OMIC) Per information from annual follow up: Subject recommende to receive regular counseling therapy-No additional information expected from the reporter. 07-Mar-2008				Y					U	10/03/2006	10/03/2006	0		PUB	OTH	NONE				MEDI0004980	1						1	Chest pain; Heart rate increased; Hyperhidrosis; Malaise; Respiratory rate increased; Chest pain; Cold sweat; Heart rate increased; Hyperhidrosis; Hypertension; Pallor	FLUN3~MEDIMMUNE VACCINES, INC.~500434P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500434P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Emergency room visit	Influenza
0264542	10/16/2006	IL	83.0	83		F	10/10/2006	Took flu shot Friday and Sunday morning went to mail box and had weakness in legs.  Could not walk so she crawled to her house and up stairs to call her daughter on the phone.  Blood pressure and pulse were normal.  Admitted to hospital for tests.  Doctor stated all tests negative.  She had same symptoms the past two years after flu vaccine but didn't relate these symptoms with the flu shot.  The symptoms have progressively worsened since the first ones 3 years ago.  Medical doctor recommended no further flu shots and reported it to our health department.  Stated after two days her symptoms ceased and she had no further problems.  Still has a little soreness in the thighs, but she can walk without difficulty.  Instructed client I would fill out form and she might be contacted.  Instructed her not to take any further vaccines in future.					Y	1			Y	10/06/2006	10/08/2006	2		PUB	UNK			Pacemaker			1						1	Asthenia; Hypokinesia; Pain; Vaccine positive rechallenge	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69240~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0264552	10/16/2006	FL	9.0	8		M	10/10/2006	Reaction happen about 10 minutes after shot (nickel size per mom). Then later that day the area began to get bigger in size. Pt was seen the next morning (10/10/06).									Y	10/09/2006	10/10/2006	1		PVT	UNK			Sensitive to Powdered gloves.			1						1	Injection site reaction	FLU3~SANOFI PASTEUR~U2273AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264553	10/16/2006	AL	1.42	1	.4	F	10/10/2006	Developed an urticarial/erythema multiforme type (target lesions) rash on 10/04 with erythema and swelling of knees and elbows and some involvement of wrists. Treated with Atarax, Resolved completely within 3 days.				Y					Y	10/03/2006	10/04/2006	1		PVT	PVT		Irritability/Teething.				1						1	Erythema; Erythema multiforme; Oedema; Skin ulcer; Urticaria	FLU3~SANOFI PASTEUR~U2174DA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0264555	10/16/2006	GA	56.0	56		M	10/16/2006	Weakness, pain in legs, hips and neck, heart racing. There was no improvement Sunday. Today pt coughing, had fever, still weak. Pt currently away from since he is a truck driver. Reporter stated pt has not had problems with Flu vaccine before.									U	10/14/2006	10/14/2006	0		OTH	PVT						1						1	Arthralgia; Asthenia; Cough; Heart rate increased; Neck pain; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~70619~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0264556	10/16/2006	IN	16.0	16		F	10/13/2006	Pain in right upper arm from time of administration of vaccine and continuing 8 days.									U	10/05/2006	10/05/2006	0	NONE	PVT	PVT		NONE				1						1	Injection site pain	FLU3~SANOFI PASTEUR~U2239AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0223F~2~~LA~HEP B (RECOMBIVAX HB)~1|HPV4~MERCK & CO. INC.~0955F~1~~RA~HPV (GARDASIL)~1	USA		Influenza
0264557	10/16/2006	FL	71.0	71		F	10/13/2006	Pt was in bathroom and felt dizzy and nauseated and fell to floor and hit head. Unsure if she lost consciousness. Daughter transported her to ER. She felt well shortly after incident. Pt describes feeling very achy in legs and general muscle aches evening of vaccine administration and slight dizziness.				Y					Y	10/11/2006	10/13/2006	2	Pt believes CBC and chemistry taken. She is to see PCP next week for further evaluation. Cat scan done and other tests per pt.	OTH	OTH	Blood pressure medicine	None known. pt stated she had a 24 hour virus a week or two ago, but no other illness or sx.	Pt has had hx of sinus problems as a teen and has had sinus surgery several years ago.			1						1	Dizziness; Fall; Loss of consciousness; Myalgia; Nausea; Pain	FLU3~SANOFI PASTEUR~U2186AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0264558	10/16/2006	OH	71.0	71		F	10/04/2006	Extreme red, hard, swelling of upper arm from elbow to shoulder continuing and including circumference of arm. Very painful, fever 98.9-100.6 2 1/2 days, intense pain, chills, welts on arm, Tues and all night. Advil Benadryl Ice.									Y	10/03/2006	10/03/2006	0		PUB	UNK	Actonel, Centrum Vit D, Crestor, Caltrate, Nexium, Total EFA	NONE	Adhesive tape,carafate, Osteoporosis			1						1	Chills; Injection site erythema; Injection site induration; Injection site oedema; Injection site pain; Pyrexia; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~A202AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1049P~2~~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264583	10/16/2006	IL	41.0	41		F	10/16/2006	Left deltoid muscle became red, hot and a lump formed within 5 minutes of receiving flu vaccine IM injection.									Y	10/16/2006	10/16/2006	0	NONE	PVT	PVT	NONE	NONE	Allergic to walnut and pecan nuts.			1						1	Injection site erythema; Injection site mass; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69479~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0264584	10/16/2006	WA	61.0	60		M	10/16/2006	Two days after flu shot, pt noticed redness/inflammation/scabbing on corners of right shoulder and on forearm. Still present.									U	10/04/2006	10/06/2006	2		OTH	PVT						1						1	Injection site erythema; Injection site inflammation; Vasodilation procedure	FLU3~SANOFI PASTEUR~U2240AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264586	10/16/2006	CA	82.0	81		F	10/13/2006	Pt received vaccine on 10/11/06. Had reaction on Friday, 10/13/06, 2 AM. Swells at site of injection and pain. Pt was advised to see physician. 16:00 on 10/13/06. No swell as per her LPN. But still pain. Advised again to see physician. As of 10/14/06, 11:00 AM, feeling better, little pain, less swelling and no redness.									U	10/11/2006	10/13/2006	2		OTH	PUB	Inhaler for asthma.	NONE	Asthma; no allergies			1						1	Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2186AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264587	10/16/2006	AZ	65.0	65		F	10/16/2006	As soon as vaccine was given, on right arm, site was hurting, had chills at night, uncontrollable cold. 10/12/06, arm was swollen, red all the way around, itched a lot, was really heavy, couldn't move it. 10/15, felt better.									U	10/11/2006	10/11/2006	0		OTH	PVT	Multivitamin; hydrocodone	NONE	Back pain; allergy to penicillin			1						1	Chills; Feeling cold; Injection site erythema; Injection site pain; Injection site swelling; Joint range of motion decreased; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0264588	10/16/2006	NE		52		F	10/16/2006	Right away, had tenderness at injection site, in face right jaw joint was tender and lasted for a couple of days. Monday 10/9, felt really fatigued, Tuesday 10/10, had severe headache, fever, not able to retain fluids, slept all day, coughing. 10/11 was vomiting, slept a lot, called doctor and was told to keep hydrated. 10/12, gradually starting eating, drinking tea, felt weak. 10/13, went to work, still felt sick, lips were ashen, pupils consricted/sensitivity to light. During the weekend, got more sleep. Today, 10/16, feels better but comments that was not able to do much for 1 week.									Y	10/04/2006	10/09/2006	5	called my family physicain but did not visit him	OTH	PUB	Multivitamin; Flomax; Toprol; Klonopin; senna	NONE	Urinary retention; problems sleeping; constipation; tachycardia; avoid Vioxx and codeine.			1						1	Fatigue; Headache; Injection site pain; Miosis; Pain in jaw; Pallor; Pyrexia; Sleep disorder; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0264615	10/16/2006	CO	10.0	10		F	10/12/2006	Redness, warmth, induration at injection site right arm.				Y					Y	10/10/2006	10/11/2006	1		PVT	UNK	Biaxin, Claritin	Sinusitis	Amoxicillin hives, Environment allergies.			1						1	Injection site erythema; Injection site induration; Injection site warmth	FLU3~SANOFI PASTEUR~U2177AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0741F~2~~RA~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~0915F~2~~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0264649	10/16/2006	TN	58.0	58		M	10/16/2006	58 year old male administered Flumist live virus vaccine that should not be given to individuals older than 50. Pt educated on influenza symptoms and instructed to report for medical care immediately if symptoms present. Pt stated he is very healthy and will comply.										10/15/2006				MIL	MIL	none noted	none	n/a			1						1	Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~500430P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0264650	10/16/2006	AZ	38.0	38		F	10/16/2006	Abdominal pain, headache, fever, chills, nausea, runny nose, cough, tiredness, facial edema.									Y	10/14/2006	10/14/2006	0	n/a	MIL	MIL	n/a	n/a	n/a			1						1	Abdominal pain; Chills; Cough; Face oedema; Fatigue; Headache; Nausea; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500431p~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0264653	10/16/2006	ID	43.0	43		M	10/16/2006	She received the vaccine on 14 Oct 06 at apporoximatley 1030.  By 1700 she was feeling dizzy and had the chills.  Her temperature at that time was 101.  She had a fever for the next 24 hours and the highest it got was 102.6.  She took ibuprofen to aleviate the fever, but it only helped her joint pain.  She then took Tylenol and her fever came down.									Y	10/14/2006	10/14/2006	0		MIL	MIL		None	None			1						1	Arthralgia; Chills; Dizziness; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500431P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0264657	10/16/2006	LA	71.0	71		F	10/16/2006	Redness and erythema to left deltoid area, instructed to use otc Benadryl orally and apply cold compresses until redness and pain subsided, if no better than to RTC.									Y	10/13/2006	10/14/2006	1		UNK	UNK	Lorazepam 0.5mg 1 daily, Fluoxetine 20mg 1 daily, Alprazolam 0.25mg Q6H prn, Premarin .625mg 1 daily, Multivitamin, Caritin 10mg 1 daily, Prilosec 20mg 1 daily, Albuterol MDI prn, Combivent BID, Synthroid 125micrograms 1 dialy					1						1	Injection site erythema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71213~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0003F~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264660	10/16/2006	CA	61.0	60		F	10/16/2006	Patient developed soreness and swelling around Right Deltoid muscle with pain on 10/13/06;  erythema developed on 10/15/06.  Patient used Ibuprofen, Tylenol, and an anti-inflammatory cream as treatment.									N	10/12/2006	10/13/2006	1		UNK	UNK	Nexium, Hydrochlorothiazide, Nasonex, Vivelle Dot, Prometrium	None.	NKDA.			1						1	Erythema; Myalgia; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71034~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0619F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264661	10/16/2006	MN	56.0	56		F	10/16/2006	Received vaccination at 3:30 pm.  At app. 7:00 pm, noticed phlemmy throat, wheezing and coughing.  At app. 2:00 am, had extreme chills and fever of at least 102, headache, body aches, head congestion, plugged left ear, mattery eyes, swollen eyelids, weakness, and was pale and gray.									Y	10/10/2006	10/10/2006	0		UNK	UNK	wellbutrin, trazadone, actonel	none	penicillin, sulfa, and bee sting allergies			1						1	Asthenia; Chills; Cough; Ear discomfort; Eye discharge; Eyelid oedema; Headache; Nasal congestion; Pain; Pallor; Pyrexia; Wheezing	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0264665	10/16/2006	CT	28.0	28		F	10/16/2006	Experienced difficulty breathing, severe wheezing, hoarseness, elevated heart rate, dizziness, hives, paleness and weakness.  I went to the emergency room and received 2 steroids, 2 benadryl and a breathing treatment.  Went home with an inhaler and benadryl.				Y					Y	10/12/2006	10/12/2006	0		UNK	UNK	Paxil, xanax when needed, kariva birth control	none	none			1						1	Asthenia; Dizziness; Dysphonia; Dyspnoea; Heart rate increased; Pallor; Urticaria; Wheezing	FLUX~UNKNOWN MANUFACTURER~62213AA~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0264666	10/16/2006	WA	33.0	33		F	10/16/2006	DIFFICULTY BREATHING, FAST HEART BEAT, DIZZINESS, PALENESS, WEAKNESS, FEVER,BODY ACHES ,VOMITING, CHEST PAIN. HEART BEAT LASTED FOR ABOUT 5 MINUTES, VOMITED 1 TIME, DIFFICULTY BREATHING FOR ABOUT 2 DAYS , DIZZINESS AND WEAKNESS FOR 3 DAYS SO FAR  AND  CHEST PAIN FOR 2 DAYS.									U	10/13/2006	10/13/2006	0	WILL GO TO THE DR.	UNK	UNK		NONE				1						1	Asthenia; Chest pain; Dizziness; Dyspnoea; Heart rate increased; Pain; Pallor; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0264667	10/17/2006	NE	62.0	62		F	10/17/2006	Nurse reported on 10/14/06 that the left upper deltoid w/ reddened, slightly raised area where pt had pneumovax given the night before.  Pt. reports that it itches, area slightly raised about 0.1 cm, measures about 1.25 cm x 1 cm.  Reported to pharmacist, stated was dermal reaction and to watch it for increase in swelling or warmth.  On 10/16/06 it measures 17 cm x 10 cm, is very tender to the touch, red, warm and swollen.  Reports her arm is aching.  Dr. thinks the area is possibly a secondary reaction and started her on Cipro 500 mg po BID for 7 days and started her on Vicodin for c/o pain.									N	10/13/2006	10/14/2006	1		UNK	UNK	Enteric Coated Aspirin 325 mg po q day, Ibuprofen 600 mg po tid w/ meals, Propranolol Hcl 20 mg po BID, Ropinirole HCl 0.25 mg po q day, Bisacodyl EC 5 mg po bid prn, Docusate Na 100 mg po BID prn, Ibuprofen 600 mg po TID prn, Promethazine	Dysphagia, basal migraine, vertigo, unsteady gait, r/o CVA, some right hemiparesis	Allergy to Penicillin, history of fibromyalgia, and had had some chest palpitations the night previous to admission, had 3 wk history of rt ear pain, woke the morning of 10/09/06 with slurred speech			1						1	Injection site erythema; Injection site swelling; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA222AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0675F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264669	10/17/2006	FL	82.0	82		F	10/12/2006	Patient was found by her son, expired.  He states it looked like she went in her sleep. 10/19/06 Received Death Certificate which states COD as Found Dead, CAD s/p angioplasty, and hypercholesterolemia with contributing factors of HTN, PVD and hypothyroidism.	Y	10/11/2006							N	10/03/2006	10/11/2006	8		PVT	PVT	Flonase, Zocor, Premarin, Synthroid, Prevacid, Disaleral		Allergic rhinitis, hypercholesterolemia, hypothyroidism, RA			1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69240~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0264694	10/17/2006	PR	43.0	43		M	10/03/2006	Depression, angry, rash, lost memory, joint pain, fever, anxiety.  Major depression, peptic ulcer disease, nonerosive gastritis of the antrum and the body of stomach, small hiatal hernia, H phylir positive. Pain in joint involving shoulder regions, subacromial shoulder injection, neuralgia of the nighth cranial nerve.  Records received-11/17/06-DX: Major depression, peptic ulcer disease, nonerosive gastritis of the antrum and the body of stomach, small hiatal hernia, H phylir positive. Pain in joint involving shoulder regions, subacromial shoulder injection, neuralgia of the nighth cranial nerve.			Y						N	12/16/2003				MIL	MIL	PPD/12/16/03					1						1	Amnesia; Anger; Anxiety; Arthralgia; Depression; Gastritis; Hiatus hernia; Neuralgia; Peptic ulcer; Pyrexia; Rash	ANTH~EMERGENT BIOSOLUTIONS~~4~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0264698	10/17/2006	MI	13.0	12		F	10/17/2006	Red swollen square shaped area on right deltoid noticed next am after immunization. Mom gave Tylenol as pt c/o pain in that area. Still present at office visit 10/16/06 and painful.				Y					Y	10/13/2006	10/14/2006	1		PVT	PVT		NONE				1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U2197AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1780AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~U1880CA~1~IM~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0264700	10/17/2006	NJ	5.0	5		F	10/13/2006	Left arm red, swollen warm to the touch. 1st day measured 4.5 x 4 left arm to above elbow. 2nd day 5x5 all around arm. TX BENADRYL, cold compress, antibiotic.				Y					Y	10/05/2006	10/06/2006	1	Blood work	PVT	PVT		NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U2273AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0264701	10/17/2006	NJ	5.0	5		F	10/13/2006	Left arm swollen, red warm to touch, 1st day measured 4x3, 2nd day 4x4. gave Benadryl, cold compress and antibiotic.				Y					Y	10/05/2006	10/06/2006	1		PVT	PVT		NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U2273AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0264702	10/17/2006	IL	24.0	24		F	10/12/2006	Within one hour after influenza shot pt had itching head. By that night itching head to toe. Hives developed with itching. Became flushed, bright red, left arm had swollen area at injection site, bright red, warm to touch, Treated with Benadryl, Medrol pack				Y						10/10/2006	10/10/2006	0	NONE	PUB	PUB	Welbutrin	NONE	Seasonal Allergies			1						1	Erythema; Flushing; Injection site erythema; Injection site oedema; Injection site warmth; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2180AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0264704	10/17/2006	IN	65.0	65		M	10/12/2006	Fever, Sever right shoulder pain.				Y					Y	10/03/2006	10/03/2006	0	Basic Metabolic profile normal	PVT	PVT		NONE	Coronary artery disease, generalized osteoarthritis.			1						1	Pyrexia; Shoulder pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71033~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0618F~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0264706	10/17/2006	OR	71.0	71		F	10/12/2006	Sore, stiff arm, couldn't move at all had to see urgent care for antibiotics and pain medication (Keflex, vicodin).				Y					U	10/09/2006	10/09/2006	0		OTH	PUB	Atenolol, Fosamax, Paxil, Prilosec, Plavix, quinine, Moxzale, Aspirin.	NONE	HBP, Osteoporosis.			1						1	Hypokinesia; Musculoskeletal stiffness; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70738~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0741R~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0264710	10/17/2006	CA	60.0	60		F	10/11/2006	4:30 pm cough, 7:30 chills, fever, seizures, swollen eyes, gue coming out of eyes, blurred vision whole body jerked for 12 hours.									Y	10/05/2006	10/05/2006	0		OTH	UNK						1						1	Chills; Convulsion; Cough; Dyskinesia; Eye swelling; Pyrexia; Vision blurred	FLU3~SANOFI PASTEUR~2X6644168~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264712	10/17/2006	NY	26.0	26		F	10/17/2006	Developed a hive and itching on her face- right side of the cheek and ear. Had bug bite on her forehead. Has respiratory allergies which have been worse this week (itchy throat and eyes)  Had a previous reaction to Compazine.				Y					Y	10/17/2006	10/17/2006	0		UNK	UNK	Aciphex (for acid reflux) Seasonel (birth control) Benadryl 25 mg administered by mouth	takes medication for irritable bowel	When in college diagnosed with Penicillin allergy at a Emergency Room.			1						1	Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70279~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0264713	10/17/2006	FL	72.0	72		F	10/17/2006	Pneumonia vaccine in left deltoid 10/14 approx 1 p.m.  During the night of 10/14, I developed pain, swelling and extreme inflammation, which progressed during the following day to involve my arm from shoulder past elbow. On 10/16 I went to my internist who prescribed prednisone (Medrol 4 mg pak)									N	10/14/2006	10/14/2006	0		UNK	UNK		none	none			1						1	Injection site inflammation; Pain; Swelling	FLU3~SANOFI PASTEUR~V2186AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1037P~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264715	10/17/2006	GA	51.0	51		F	10/17/2006	Onset of Headache, Sinuses swelling, pain in eyes, nose, teeth, neck and chills about 3:15;  Temp 100.1 at 5:30 with severe body aches;  Temp of 101 with all previous symptoms and difficulty breathing through nose at 6:00.  Treated with: Excederin + oxycodone (per Emory Dr on call)- temp down to normal at 11:55.  Today (October 17th), body aches and extreme fatigue.										10/16/2006	10/16/2006	0	Nowhere else on form to add to #13: On MArch 8th,2006 was given tetanus innoculation.  Had severe reaction: swelling of arm, intense pain for 2 weeks with 3 large PAINFUL blotches swollen on left arm.	UNK	UNK	Excederin -500 mg, oxycodone 5/325, Ultram & Skellaxin 800 mg		Allergies: Penicillan, Tetracycline, Sulfa, Quinines, Arithromycin, Epi, ceflex, Ceclor, Cipro	FLu for 3 weeks~Influenza (Seasonal) (no brand name)~~0.00~Patient		1						1	Chills; Dyspnoea; Eye pain; Fatigue; Headache; Neck pain; Pain; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0264718	10/17/2006	OH	33.0	33		F	10/17/2006	Developed L arm pain at injection site within 1 hour of immunization (9:30 am) Pain radiates down her arm to her fingers and up into her L neck & head. Developed a severe headache that persisted and some nausea despite Ibuprofen 600 mg at time of presentation to Employee Health 12noon.  Was released to return home from work today.									U	10/17/2006	10/17/2006	0		UNK	UNK	Zoloft, Advair, OTC decongestant, Iron Supplement, rescue Albuterol inhaler		Hx allergy to Biaxin, Hx asthma, Iron deficiency anemia & endometriosis			1						1	Headache; Injection site pain; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU216BA~3~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0264722	10/17/2006	TX	54.0	54		F	10/13/2006	Friday evening right arm swollen, hot, and red. Could not sleep.  Got up Sturday morning with chills and 102.4 fever.  Took aspirin.  Called school nurse.  She called back in afternoon and told me to call my doctor.  I called him and he told me to take 600 mg ADVIL every six hours and to continue the fluids.  I have been doing this since Saturday evening.  My are is still red, tender, and a little warm.									Y	10/13/2006	10/13/2006	0		UNK	UNK		none	none			1						1	Chills; Erythema; Injection site warmth; Pyrexia; Sleep disorder; Swelling	FLU3~PFIZER\WYETH~~2~IM~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|PPV~MERCK & CO. INC.~0619F~2~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~U1217DB~2~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0264723	10/17/2006	MN	1.0	1	.0	M	10/17/2006	Erythema Multiforme Fever DC DX: erythema multiforme without mucositis or mucosal involvement. Febrile viral upper respiratory illness. HX: presented with 2 day hx of progressive rash, began on Friday evening 10/6/06. seen in urgent care on 10/7/06. Had been receiving amoxicillin for sinus infection had taken for approximately 1 week. Instructed to discontinue medication and begin Benadryl. At time of presentation ot urgent care the rash was mild in appearance, however, over 12-24 hours rash spread and now involves ears and remainder of body surface. Not febrile during this time.Sinus symptoms had resolved. PMX includes strep throat once and sinus infection once. Febrile during hospitalization temp max of 104.					Y	3			Y	10/05/2006	10/06/2006	1	Electrolytes, Blood Culture, CBC Labs: metabolic panel BUN/creatinine ratio 57, A/G ratio 2.1. Blood culture negative. Hemaglobin 13.2.	UNK	UNK						1						1	Erythema multiforme; Pyrexia; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~U2174HA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB133AA~1~IM~RL~HEP A (HAVRIX)~1|MMRV~MERCK & CO. INC.~0832F~1~SC~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Hospitalisation	Influenza
0264730	10/17/2006	NM	6.0	6		M	10/16/2006	Mom called office 10/16/2006 at 1347.  Child had broke out in head to toe hives about 1/2 hour after flu shot.  Gave BENADRYL and improved.									Y	10/16/2006	10/16/2006	0	NONE	PVT	PVT		NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2193AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264731	10/17/2006	WA	2.0	2	.7	M	10/05/2006	Gave 0.25 cc Fluvirin instead of Fluzone in left thigh IM.									Y	10/05/2006	10/06/2006	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70091~1~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0264732	10/17/2006	VA	39.0	39		F	10/16/2006	Severe tender and erythema of injection site.  No fever									U	10/02/2006				PVT	UNK		NONE	NONE			1						1	Injection site erythema; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69479~UNK~~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C2557AA~UNK~~RL~TDAP (ADACEL)~1	USA		Influenza
0264733	10/17/2006	PA	30.0	30		F	10/17/2006	Rash, urticaria upper torso, arms and face.  Treatment BENADRYL 50 mg by mouth.									Y	10/17/2006	10/17/2006	0		OTH	PVT	NONE	NONE	NONE			1						1	Rash; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71034~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0264734	10/17/2006	MA		42		F		Vaccine was given 10/9 at local grocery store.  Developed left arm pain 10/10 with swelling,myalgia, fever (started10/11) and left side trunk and left leg pain.  Seen 10/13 with persistent symptoms.				Y					Y	10/09/2006			NONE	OTH	OTH			failed back syndrome, depression			1						1	Myalgia; Pain; Pyrexia; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0264737	10/17/2006	PR		37		M		Problem breathing while sleep, back pain, abdomen pain, numbness arms, legs.										11/02/2003				MIL	MIL						1						1	Abdominal pain; Back pain; Dyspnoea; Hypoaesthesia	ANTH~EMERGENT BIOSOLUTIONS~~UNK~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0264724	10/18/2006	FL	24.0	0	.0	F	10/18/2006	Influenza vaccine administered at 10 am.  Developed headache and fever at approx 7 pm; maximum fever 102.3 (Rectal), subsided by 2 pm.									Y	10/10/2006	10/10/2006	0	None Did not seek medical attention	UNK	UNK		None	None			1						1	Headache; Pyrexia	FLU3~SANOFI PASTEUR~U2197AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264729	10/18/2006	WA	33.0	32		F	10/17/2006	Tightening of throat, sever pain at injection site, with lump at injection site.									Y	10/17/2006	10/17/2006	0		PUB	PVT	NONE	NONE	Milk, dairy allergy, heart murmur.			1						1	Injection site mass; Injection site pain; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA206AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0264833	10/18/2006	NJ	20.0	20		M	10/17/2006	Within days of vaccination (smallpox) Pt described constant headache, dysarthria, and incoordination. MRI c/w cerebritis-cerebellitis. Tx IV steroids, Acyclovir, TCN.  11/7/06 Received medical records from 1st hospital which reveal patient admitted 10/12/06 w/bifrontal HA & slurred speech following small pox vax 10/6/06.  Initial CT of brain was WNL.  Then developed left facial weakness & mild asymmetry of reflexes.  MRI then revealed T2 signal in right superior & mid frontal gyri.  Initial labs were WNL.  LP revealed WBC 245, 91% lymphs, protein 194, glucose 58.  Tx for presumptive meningoencephalitis & suspected post vax reaction, viral .  Tx w/steroids, antivirals & antibiotics IV.  Appeared stable x 2 days then abruptly developed worsening speech, ataxia & repeat MRI showed new bilateral cerebellar T2 hyperintensity.   Final/Transfer DX: probable post immunization reaction with meningoencephalitis initially focal & now with bilateral cerebellar involvement.  Transferred to second hospital on 10/18/06. 1/23/07 Received medical records from 2nd hospital which included: 1. Additional progress notes records from community hospital. 2. Medical records from clinic s/p release from second hospital which relate s/s to smallpox vac reaction.  Still had speech difficulty, slow gait, right hand tremors & intermittent vision difficulty.  Was receiving PT/OT/ST.  As of 12/11/06 2-4 more mo of rehab recommended before returning to active duty.  Still having trouble with balance & gait disturbance. Vax records included here reveal patient received FluMist & Smallpox on 9/29/06. 3. D/C summary from 2nd hospital for 10/19-10/25/06 admit as well as H&P. 4. VHC Summary: Patient received anthrax, smallpox, flumist, & Hep A&B in preparation for deployment.  Patient developed frontal HA approx 6 days after receipt of vax which grew progressively worse until awoke 10/12 with slurred speech, difficulty walking, blurred vision, & hand tremors.  Went to Troop Medical Center then to civilian ER & was admitted.  MRI of brain was positive for ill defined abnormal T2 hyperintense signal involving gray & white matter of right superior frontal & right middle frontal gyri with suggestion of cortical thickening.  Admitted 10/12/06-10/19/06 & then transferred to second hospital. FINAL DX: post vaccination cerebellitis. Follow-up: C/O worsening frontal headache behind his eyes for 3-5 days that was not ameliorated with TYLENOL. On 12 Oct 06 he developed slurred speech, difficulty focusing his eyes and unsteadiness in his gait. He was seen and sent to ER. He denied chest pains, fever, SOB, nausea, vomiting, arthralgias, myalgias or any symptoms of a URI. Headache, general Start: 10/06/2006 End: 10/13/2006. Comment: frontal, behind eyes and occipital. Symptom: Gait abnormality Start: 10/12/2006 Comment: trouble with coordination (jumping, running, walking back wards). Symptom: Cognitive deficiency Start: 10/12/2006 End: 10/22/2006. Comment: has trouble with word finding and slurred speech when tired. Symptom: Tremors Start: 10/12/2006 End: 10/22/2006 Comment: of hands.				Y	Y	12			Y	09/29/2006	10/12/2006	13	LABS: MRI positive.  CSF revealed WBC 245, RBC 7, poly 4, lymphs 91, monos 5, o eos, protein 194, glucose 58.  ESR 50.  C/S neg.  WBC 9,600, 62 segs, 29 lymphs, 8 monos, 1 eos. Diagnostic Tests: MRI-positive for ill-defined abnormal T2 hyperintense signal involving the gray and white matter of the right superior frontal and right middle frontal gyri. There is a suggestion of cortical thickening. Lumbar tap- WBC 245; RBC 7 with 4% poly; 9% lymphocytes; 5% monocytes; 0% eosinophils; CSF-gram stain no WBC; no organisms; Culture-no growth 72 hrs. EKG- Normal sinus rhythm; Labs: 12 Oct 06 CRP 2.8; 13 Oct 06 CBC-WBC 9; 600; Hgb 12.7; Hct 36.7; PLT CT 263; 000 with 62%segmental; 0 basophil; BUN 10; Cr. 1; SGOT 22; SGPT 16; Alkaline Phosphate 61.	MIL	MIL	None	Slight cold	PMH: patients mother has had MS for approx 10 years. None			1						1	Cerebellar syndrome; Coordination abnormal; Dysarthria; Headache	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~PFIZER\WYETH~4020076~1~~UN~SMALLPOX (DRYVAX)~1	USA	Hospitalisation	Influenza
0264837	10/18/2006	LA	1.29	1	.3	M	10/18/2006	3 days after vaccines given (DTaP, IPV, MMR, Flu shot), pt had fever 103, seizure, URI SX and mild RAD exacerbation. ER DR DX with pneumonia but radiology reading of CXR is normal. PT HX has frequent URI and RAD. Unclear as to whether the febrile seizure was from vaccines or illness although illness was not fairly mild. Treatment included antipyretics, antibiotics, breathing treatments, antihistamine and decongestant.				Y					Y	10/03/2006	10/06/2006	3	CXR normal	PVT	PVT	Had used Xopenex, Pulmicort a few days before vaccinations.		Reactive airway disease, Eczema.			1						1	Asthma; Condition aggravated; Convulsion; Febrile convulsion; Pneumonia; Pyrexia; Upper respiratory tract infection	DTAP~SANOFI PASTEUR~C2638AA~4~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2174HA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1031~3~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0700F~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0264881	10/18/2006	OH	5.0	4		M	02/02/2006	A 4 year old male child with with no known allergies and history of asthma developed a large reddened and warm area at the injection site at an unspecified time the day he received IM influenza vaccine (Fluzone SV 2005-2006), lot no U1838AA in the right thigh on 10/25/05. He had also received, the same day, IM Tripedia in the left thigh, IM inactivated poliomyelitis vaccine (IPOL) in the left thigh and SC MMR vaccine in the right thigh. He was concomitantly taking  albuterol PRN. Flovent and Singulair QD at the time of the report. The pt consulted the physician on 10/29/2005, and he was recovering slowly at the time of the report. Follow up information received on 1/30/06 from a health care provider. The pt had received two previous flu vaccinations without any reaction. At the time of this report, the pt had fully recovered.				Y					Y	10/25/2005	10/25/2005	0		PVT	PVT	Albuterol PRN, Flovent, Singulair QD.		No known allergies, Asthma		200502233	1						1	Injection site erythema; Injection site warmth	DTAP~SANOFI PASTEUR~U1349AA~UNK~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1838AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0265~UNK~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0995P~UNK~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0264894	10/18/2006	TX	35.0	35		F	10/18/2006	Patient developed erythema to L Deltoid, warm to touch and soreness. Vaccine administered 10/16/06 (4pm). Local skin reaction occurred within 24 hours. Patient given antihistamine to aid with allergic reaction 10/18/06. Patient is to take Benadryl 25mg at bedtime 10/18/06. Patient was asked to report no change in status or if condition worsens. Follow-up by Employee Health Nurse twice daily.									N	10/16/2006	10/17/2006	1		UNK	UNK		None	NOne			1						1	Erythema; Hypersensitivity; Injection site warmth; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71216~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0264895	10/18/2006	TX	48.0	48		F	10/18/2006	Patient reported local erythema with redness and induration approx 7cm circumferentially. Patient reported soreness and area warm to touch. Patient vaccinated 10/13/06 and had edema 10/14/06 in am. Patient states she took Tylenol for discomfort. Monday 10/16/06, patient signs and symptoms had subsided. Employee Health Nurse did review symptoms with patient, no further signs are present.									Y	10/13/2006	10/14/2006	1		UNK	UNK		None	None			1						1	Erythema; Injection site induration; Injection site pain; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71216~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0264898	10/18/2006	FL	29.0	28		F	10/18/2006	10/12/06 daytime: c/o arm hurting, sore, & cold symptoms; 10/12/06 PM to emergency room with dizziness, spasms into neck and shoulder, decreased ability to move arm, heart beating fast.  At ER, BP was elevated, pulse 133. Many yrs prior had reaction to flu vaccine, but no problems in subsequent years.				Y					Y	10/10/2006	10/12/2006	2		UNK	UNK			allergy to ASA			1						1	Blood pressure increased; Dizziness; Hypokinesia; Muscle spasms; Pain; Pharyngitis; Rhinitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70385~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0264900	10/18/2006	IL	25.0	25		F	10/18/2006	Stomach pains, fever, chills, bloody diarrhea. Was seen in ER and given IV fluids.				Y					Y	10/17/2006	10/17/2006	0	x-rays, labs	UNK	UNK	zoloft	none	PCN			1						1	Abdominal pain upper; Chills; Diarrhoea haemorrhagic; Pyrexia	FLU3~SANOFI PASTEUR~~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0264902	10/18/2006	MA	71.0	71		F	10/18/2006	Approzimately seven hours after a flu shot was given (1:15P to 8:30P)patient started with the chills and unable to get warm, shortly after the patient along with the chills began to shake uncontrollably. Patient an LPN, took her blood pressure and it was in the low 200's, tempurature was 98.2.  We then called our Doctors office who advised we go the local hospital emergency room. Upon arriving at the hospital, patients blood pressure was taken and was 163/93 very high for the patient who usaully is in the low 120's over 60's, no change in temp.  Patient was seen and examined by a doctor who felt it was a adverse reaction to the flu shot, not an allergic reaction. By this time the shakes and chills had begun to calm down.  Doctor had patient relax laying down for an hour after which her blood pressure was taken again and it was normal, shakes had subsided, so was discharged to go home and told she should feel better winthin 24 to 48 hours and if she didn't contact her primary doctor.  She is feeling better this morning, but has headache and feels all washed out.				Y					N	10/17/2006	10/17/2006	0		UNK	UNK		NONE				1						1	Blood pressure increased; Chills; Fatigue; Headache; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0264903	10/18/2006	NY	41.0	41		F	10/18/2006	Patient received a dose of Influenza vaccine (as noted below) at approximately 8:00am.  At approximately 11:00am the patient notes the onset of itchyness  at 11:25am Clinic staff was notified. At that time the patient's BP was 156/96 Pulse 76, Resp 18 no distress.  the patient's face was flushed and scalp was red.  Her colleagues reported that her face appeared puffy.  There was no respiratory distress or involvement.  Patient was monitored for 20 minutes and all symptoms resolved on their own.  Reaction was isolated to head and face.									Y	10/18/2006	10/18/2006	0	Patient is currently under care for ideopathic Hives.  She is working with a dermatologist and allergist to determine the cause.  She will notify them of the occurence and will follow up with her PCP should symptoms recurr.	UNK	UNK	None noted	None	currently assessing idiopathic hives as noted above			1						1	Blood pressure increased; Erythema; Face oedema; Flushing; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2256AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264904	10/18/2006	FL	22.0	22		F	10/18/2006	Cellulitis left deltoid; T 100.6 F; headache; localized swelling; erythema; raised rash 8-10 mm at injection site. Treated with Keflex.				Y					Y	10/16/2006	10/17/2006	1	N/A	UNK	UNK	Birth control pills	none	none			1						1	Cellulitis; Erythema; Headache; Injection site rash; Pyrexia; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70279~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1046P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0264905	10/18/2006	FL	56.0	56		F	10/18/2006	Employee reports Nausea, Vomiting, Diarrhea, Severe epigastric pain the evening after she took the flu vaccine earlier that morning. Symptoms subsided and she was ok by 5:00am the next morning. Is not sure it was related to vaccine but did want it reported.									Y	10/11/2006	10/11/2006	0	Was diagnosed with breast cancer in August 2005 and is taking Femara.	UNK	UNK	Femara	None	Cancer of breast in August 2005 with surgery.	Dizziness, Weakness~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Abdominal pain upper; Breast cancer; Diarrhoea; Nausea; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA211BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0264908	10/18/2006	TX	47.0	47		F	10/18/2006	Patient reports erythema to L arm followed by muscle soreness and itching. There is induration noted approx 7cm. Patient reports reaction 10/17/06 around 5pm but states she applied topical cortisone to area for relief of itching. 10/18/06 am she noted that there was redness and edema to site with area warm to touch.  Area was assessed, no broken skin noted, and patient is afebrile (and has been throughout symptoms). Oral antihistamine (Claritin) given and area was assessed bid. Patient was asked to take oral Benadryl at bedtime and area will be reassessed in am. Advised to contact Employee Health for any other symptoms or concerns.									N	10/16/2006	10/17/2006	1		UNK	UNK	Topical Hydrocortisone cream applied to site at home 10/17/2006					1						1	Erythema; Injection site erythema; Injection site swelling; Injection site warmth; Myalgia; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71216~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0264910	10/18/2006	AK	47.0	47		F	10/18/2006	Injection given on 10-16-06 in Left deltoid - red, bruised, warm to touch reaction approx. six inches in length and mildly itchy.  Treatment at home with warm packs to area, over the counter anti-itch cream.									N	10/16/2006	10/17/2006	1		UNK	UNK						1						1	Contusion; Injection site erythema; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U2238AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264916	10/18/2006	NY	3.0	3		F	10/18/2006	Right arm has swelling, erythema, tenderness and pain since administration of vaccine on 10/16/06, area began to increasing site on day of administration yesterday (10/17/06)  bullae which continued to increase in number and weep today. Put on Keflex 10 day.				Y					U	10/16/2006	10/16/2006	0	NONE	PVT	OTH	Inmsulfate	NONE	Anemia, Blaunt disease (leg bowing).			1						1	Crying; Dermatitis bullous; Injection site erythema; Injection site oedema; Injection site pain; Tenderness	FLU3~SANOFI PASTEUR~U2175GA~3~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0264918	10/18/2006	IA	81.0	80		F	10/18/2006	Bruising on the arm the night after the injection.									Y	10/12/2006	10/12/2006	0		UNK	UNK	Coumadin					1						1	Contusion; Injection site reaction	FLU3~SANOFI PASTEUR~U2216AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264920	10/18/2006	PA	52.0	52		F	10/18/2006	Pt woke in the morning stating her eyes were swollen shut and face was swollen. No itching, no SOB, rash to face and chest.									Y	10/17/2006	10/18/2006	1		OTH	PVT						1						1	Eye oedema; Face oedema; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71034~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0264921	10/18/2006	IL	67.0	66		U		Had pneumonia shot at approx 1400 state around 1600 arm began to swell. In the evening felt chilled, had a low grade fever. Phoned health dept around 10:00 on 10/18 stating that are was red, warm and swollen, bigger than her head.									U	10/17/2006	10/17/2006	0		PUB	PVT		NONE	Penicillin			1						1	Chills; Injection site erythema; Injection site oedema; Injection site reaction; Injection site warmth; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69895~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0391F~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264988	10/18/2006	PA	70.0			F		Pt Came back to pharmacy and had some swelling of the arm near the injection site. I offered her oral Benadryl capsules 2 (25mg) caps.									Y				NONE	OTH	OTH						1						1	Injection site oedema	FLU3~SANOFI PASTEUR~U2215AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0391F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264932	10/19/2006	IL	25.0	24		F	10/15/2006	Pt present about 30 mins after exposure to latex and about 45 mins after getting flu mist. Symptoms began with local itch on chin and progressed to itching all over. No dyspnea/ dizzy.				Y					Y	10/14/2006	10/14/2006	0		MIL	MIL		C/O itching to bottom of mouth reaction to vaccine.	Allergy to latex, itching and swelling.			1						1	Pruritus	FLUN3~MEDIMMUNE VACCINES, INC.~500430P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0264933	10/19/2006	GA	73.0	73		F	10/16/2006	Pain in arm (unable to lift it high), extreme pain (as of this date I still have this pain, Vomit 3x on 10/06/06, diarrhea on 10/06/06.				Y					N	10/06/2006	10/06/2006	0		OTH	UNK						1						1	Diarrhoea; Hypokinesia; Injection site pain; Pain; Vomiting	FLUX~UNKNOWN MANUFACTURER~70277~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~06197~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0264956	10/19/2006	UT	1.03	1	.0	F	10/18/2006	Zostavax given to 1 year old child rather than ProQuad. Parents advised to watch for redness, swelling at inj site, C Pox rash in 1-3 wks, bring child in for ProQuad in 3 months.									Y	10/17/2006				PUB	PVT						1						1	Medication error; Medication error	FLU3~SANOFI PASTEUR~U2174GA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0144F~1~IM~LL~HEP A (VAQTA)~1|HIBV~MERCK & CO. INC.~0494P~3~IM~LL~HIB (PEDVAXHIB)~1|VARZOS~MERCK & CO. INC.~0981F~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1|VARZOS~MERCK & CO. INC.~0981F~UNK~SC~UN~ZOSTER LIVE (ZOSTAVAX)~2	USA		Influenza
0264965	10/19/2006	IL	71.0	71		F	10/19/2006	Patient called indicating that her right arm was swollen, sore.  This is the arm she recieved the pneumonia shot in.....  She applied ice to her right arm.									Y	10/12/2006	10/12/2006	0		UNK	UNK		Unknown	Unknown			1						1	Pain; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70385~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~486F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264966	10/19/2006	MO	68.0	68		F	10/19/2006	Client called us indicating that her arm swelled, and exhibited hives.  She called her physician and us to report the incident.									Y	10/03/2006	10/03/2006	0		UNK	UNK		Unknown	Unknown			1						1	Swelling; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFlua211AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0264967	10/19/2006	MO	51.0	51		F	10/19/2006	Arm was swollen, hot to the touch...client indicated temperature of 102.  Client called her physician....doctor ordered antibiotics/ibuprofen.				Y					Y	10/09/2006	10/09/2006	0		UNK	UNK	Unknown	Unknown	Unknown			1						1	Injection site warmth; Pyrexia; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70385~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0485F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0264968	10/19/2006	IL	73.0	73		F	10/19/2006	Pain shooting down back and arms.  She put ice on it and elevated her arm...									Y	10/17/2006	10/17/2006	0		UNK	UNK	Unknown	Unknown	Unknown			1						1	Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70620~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0264970	10/19/2006	CT	36.0	36		F	10/19/2006	Patient received an influenza vaccination at hospital sponsored clinic for employees at approximately 8:30am.  She began to experience itching of the hands approximately 2 hours later, developed generalized hives - seen by Nurse, immediately escorted to Emergency Dept - received IV fluids, IV solumedrol, oral benadryl, albuterol via neb(has asthma).  Discharged home after treatment.  Instructed to remain out of work for one additional day.				Y					Y	10/19/2006	10/19/2006	0		UNK	UNK	None known	No	Environmental allergies, asthma			1						1	Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~702777~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0264971	10/19/2006	IL	68.0	68		M	10/19/2006	Redness & Swelling & itching									Y	10/05/2006	10/05/2006	0		UNK	UNK	Unknown	Unknown	Unknown			1						1	Erythema; Pruritus; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69428~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0485F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264975	10/19/2006	IL	70.0	70		F	10/19/2006	Soreness, Hives & lumps under axillary to breast area.				Y					Y	10/05/2006	10/06/2006	1		UNK	UNK	Unknown	Unknown	Unknown			1						1	Breast mass; Pain; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69428~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0485F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0264976	10/19/2006	IL	68.0	68		F	10/19/2006	Real sore.  Little bit of chills, No swelling or redness. Left arm/pneumonia shot.									Y	10/05/2006	10/05/2006	0		UNK	UNK	Unknown	Unknown	Unknown			1						1	Chills; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70383~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0485F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0264985	10/19/2006	PA	5.0	5		M	10/16/2006	10/14/2006 pt presented with lateral thigh edema, erythema, cellulitis at site treated for cellulitis with Augmentin.										10/12/2006	10/13/2006	1		PVT	UNK			NONE			1						1	Cellulitis; Injection site erythema; Injection site oedema	FLUN3~MEDIMMUNE VACCINES, INC.~500434P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~MERCK & CO. INC.~0804F~UNK~IM~LL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~0976F~UNK~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0264986	10/19/2006	AL	1.27	1	.3	M	10/19/2006	Fever 102, vomited x 1									Y	10/17/2006	10/18/2006	1		PVT	PVT		NONE	NONE			1						1	Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2147HA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB124AA~1~~RL~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1046F~1~~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0264984	10/20/2006	CA	2.0	2	.4	F	10/19/2006	Pt became dramatically apneic 5 days after receiving flu vaccine. No other SX noted.				Y					Y	10/04/2006	10/09/2006	5	MRI neg	PVT	PVT		NONE	NONE			1						1	Apnoea	FLU3~SANOFI PASTEUR~U2174GA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265005	10/20/2006	HI	0.6	0	.6	F	10/13/2006	12/25/2004 Seen in ER for 2 week HX of cough, runny nose, weakness, crying. Not admitted 12/29/04 admitted to medical center diag with Guillain Barr syndrome. Hosp 2 weeks diag with dysphegia, tube fed for 3 months.   12/18/06 Received hospital medical records which indicate patient was hospitalized 12/29/2004-1/12/2005. Final Dx: Guillian Barre Syndrome; LLL atelectasis; swallowing difficulties/aspiration. Records reveal patient experienced gradual worsening of cough, respiratory distress & difficulty feeding over 2 weeks.  Gradual lethargy leading to loss of head control & limb movement. PCP treated for reactive airway diseas on 3 visits & was seen in ER x 1 for stridor secondary to viral syndrome.  Neuro consult done.  Noted to have general hypotonia with grunting respirations.  Treated w/IVIG.  Slow improvement.  PT/OT/feeding consults done with slow improvement.  Remained on NG tube feeds at d/c to home with Home Health nursing.			Y		Y	14				11/01/2004	12/11/2004	40	Barium swallow 1/20/06 mild dysphegia, Barium swallow 7/7/05 mild/mod dysphagia  Medical records LABS: MRI of spine & brain showed thickening & enhancement of cauda equina & prominant extra axial fluid in brain c/w GBS.  CSF showed protein 195, glucose 73, WBC 4.	PVT	UNK			Birth hx: NSVD, pregnancy complicated by maternal gestational diabetes.   Medical records PMH: Admitted at 2 mos of age to r/o sepsis which was viral.			1						1	Agitation; Aspiration; Asthenia; Atelectasis; CSF test abnormal; Cough; Dysphagia; Feeding disorder neonatal; Guillain-Barre syndrome; Hypotonia; Lethargy; Respiratory distress; Rhinorrhoea; Viral infection	FLUX~UNKNOWN MANUFACTURER~~1~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0265006	10/20/2006	IL	67.0	67		F	10/19/2006	Had pneumonia vaccine on 10/17/2006 states was sore that evening. Noticed the following day red streaks near vaccine. On 10/19 states, has several blotches on front and back of arm.										10/17/2006	10/18/2006	1		PUB	UNK		NONE	NONE			1						1	Injection site erythema; Pain; Rash macular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70739~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0391F~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265008	10/20/2006	CA	66.0	66		F	10/13/2006	left arm cellulitis like reaction.									N	10/11/2006	10/13/2006	2		PUB	OTH	Albuterol, Lexapro, Ambien.	COPD	NONE			1						1	Cellulitis; Injection site reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71033~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1047P~UNK~~LA~PNEUMO (PNEUMOVAX)~1|TD~AVENTIS PASTEUR~U1724BA~UNK~~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0265009	10/20/2006	TX	57.0	57		F	09/27/2006	09/27/2006 pt reported, left deltoid hot to touch hard, red and no rash. Follow up 10/13/06 pt states 9/28/06 that area cleared.									Y	09/26/2006	09/27/2006	1		UNK	OTH	NONE		NONE			1						1	Injection site erythema; Injection site induration; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~09428~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0003F~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265010	10/20/2006	NM	33.0	33		M	10/16/2006	10/11/06 3:00pm hives under arm went to hospital, got Benadryl, then hives spread over abdominal area, under arm, chest, itching on leg and stomach. 10/13/06 cleared up.									Y	10/11/2006	10/11/2006	0		OTH	OTH	Albuterol, Clybumide.		Asthma, Diabetes, allergy to Phenobarbital.			1						1	Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~71213~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0265011	10/20/2006	TX	69.0	69		F	10/16/2006	10/15/06 arm tender 2 hours after shot, 10/16/06 red with whelps 2 inch diameters, tender and aching to touch. Pt states 10/17/06 slight redness, but resolving. No whelps at this time.									U	10/15/2006	10/15/2006	0		OTH	OTH	Glucophage, Effexor, Detrol,		Allergy to grass, dust, Penicillin, E Mycin.			1						1	Injection site erythema; Pain; Tenderness; Urticaria	FLU3~SANOFI PASTEUR~2274AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0003F~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265012	10/20/2006	MD	62.0	62		F	10/17/2006	Day after getting shot I suddenly began to itch all over from head to foot, stinging itches. Horrible lasted 45 minutes till I used medicated powder. Never had a reaction in past Had red rash all over.									Y	10/05/2006	10/06/2006	1		PUB	OTH	HRT, Singulair, Calcium, Multi vitamin, Fiber.		Asthma controlled by Singulair.	only small aches in past~ ()~~0.00~In Patient		1						1	Erythema; Pain; Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0265014	10/20/2006	PA	1.12	1	.1	M	10/16/2006	Pt presented in clinic 10/14/06 with clinical disease chicken pox. Had varicella vaccine on 12/21/04.										10/21/2004	10/14/2006	723		PVT	PUB	NONE		Ventricular septal birth defect, asthma.			1						1	Drug ineffective; Viral infection	FLU3~SANOFI PASTEUR~U1469AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0854P~1~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1106N~1~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0265015	10/20/2006	PA				M	10/13/2006	Client thought that vanish point needle broke off in left deltoid, denied pain. Found on further examination that needle point was not in clients arm. Client was not injured.									Y	10/13/2006	10/13/2006	0	Physical exam	OTH	PVT		Anxiety	UNK			1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71215~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265016	10/20/2006	MA	1.82	1	.8	M	10/13/2006	Pt was given Fluviron 0.25 cc instead of Fluzone 0.25, Fluviron recommended to be given over age 4. Department of public health notified. Has not been approved over age 4. No ill effects. Revaccinated in 25D with Fluzone. Immune response may not be effective.										10/12/2006	10/12/2006	0		PVT	PVT		NONE				1						1	Medication error	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71034~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265017	10/20/2006	OR	69.0	69		F	10/17/2006	24 hours after inj Bells Palsy face sag, pain behind ear, eye tear and not fully shut, cant lift brow, increase BP, no pucket mouth, drool, difficulty with suck.									N	10/11/2006	10/12/2006	1		OTH	PVT	Aggrenox, Synthroid, Paxil, ASA.		4yr post CVA.			1						1	Blood pressure increased; Drooling; Eye disorder; Facial palsy; Lacrimation increased; Pain	FLU3~SANOFI PASTEUR~42186AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265018	10/20/2006	NC	71.0	70		F	10/16/2006	Inflammatory arthritis right shoulder (injection given in right arm).				Y						10/05/2006	10/16/2006	11		UNK	UNK						1						1	Arthritis; Inflammation	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA202BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0265019	10/20/2006	NE	38.0	38		F	10/16/2006	Red streaked upper arm. Firm and tender swelling at site of injection.									Y	10/12/2006	10/13/2006	1		PVT	OTH		NONE	NONE			1						1	Injection site erythema; Injection site oedema; Tenderness	FLU3~SANOFI PASTEUR~U2202AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2559AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0265037	10/20/2006	MD	31.0	31		F	10/20/2006	I recieved the flu mist vaccination on 10/17 at 9:30 AM.  Within a few hours, I developed a headache and nasal congestion.  Over the next two days, these symptoms continued and worsened.  By the evening of 10/19, I was feeling terrible.  Throughout the night, I progressed to having extreme chills, fever, sweats, body aches, a pounding headache and nasal congestion/running nose.  Today is 10/20, and these synptoms are still present. I feel terrible and very ill.									N	10/17/2006	10/19/2006	2		UNK	UNK	None	No illness until the vaccination.  Then became progressively ill. My three young children and husband are perfectly healthy.  My 3- year old son had the injection for flu on the same date.  He is fine.	None			1						1	Chills; Headache; Hyperhidrosis; Malaise; Nasal congestion; Pain; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0265038	10/20/2006	MD	72.0	72		F	10/20/2006	High Fever and general feeling of being ill. He received the influenza and pneumonia vaccine at 10:30 AM. He is starting to feel better this AM and the fever broke about 7:00AM. The  right arm from the pneumonia shot is very sore and weak.									Y	10/19/2006	10/19/2006	0		UNK	UNK		none	Asthma, heart condition			1						1	Injection site pain; Malaise; Pyrexia	FLUX~UNKNOWN MANUFACTURER~71356~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~D619F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265039	10/20/2006	NC	65.0	65		F	10/20/2006	PATIENT RECEIVED PNEUMOVAX RIGHT DELTOID INTRAMUSCULAR ON 10/18/2006. PATIENT IS IN CLINIC TODAY WITH COMPLAINTS OF SLIGHT TENDERNESS/SORENESS AT SIGHT OF INJECTION THAT BEGAN THIS MORNING. PATIENT ALSO HAD TWO DISTINCT RED AREAS MEASURING 20 CENTIMETERS IN LENGTH AND 7 CENTIMETERS WIDE EXTENDING LATERALLY ACROSS THE RIGHT BICEP.  EDUCATED PATIENT ON VACCINE AND POSSIBLE SIDE EFFECTS AND TO SEEK MEDICAL ATTENTION IMMEDIATELY IF SYMPTOMS WORSEN OR BECOME LIFE THREATENING.									U	10/18/2006	10/20/2006	2		UNK	UNK	NO	NO	NO			1						1	Injection site erythema; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69480~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1048P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265040	10/20/2006	MO	74.0	73		M	10/20/2006	Received Zostavax and flu vaccine on 10/11.  Developed fever 102.4 documented on 10/18.  Was admitted for IV fluids.  No other obvious source found.  Had recently been hospitalized and operated for small obstruction which made him susceptible to the dehydration factor.  No infectious etiology found related to fever.  Hospital and PCP MRs received documenting 73 yr old who presents 1 week s/p Flu and Zostavx immunizations with fever, dysuria, and not feeling well.  Patient reports need to push on bladder to empty. Admitted to hospital for hydration and IV antibiotics.   Impression: Suspect UTI from inability to empty bladder well.  Doubt reaction to Zostavax  Discharge DX: Fever,  Dehydration, Hydronephrosis, BPH with outlet obstruction, concha bullosa, anemia, and past hx. of abd. incision dehiscence.					Y	2			Y	10/11/2006	10/18/2006	7	CBC no shift, CXR, Urine culture, blood cultures negative. LABS and DIAGNOSTICS: Renal US shows mild left hydronephrosis and moderate postvoid residual.	UNK	UNK	Meds: metamucil, Ergocalciferol, Flomax, Lidocaine/Prilocaine topical, Hyoscyamine sulfate PRN, vitamins, Vitamin D, and sulfamethoxazole-trimethoprim.	superficial wound infection with B. fragilis.	allergy-phenergan history of colectomy for ulcerative colitis, osteoporosis, vitamin D deficiency PMH:  COPD, Hypertension, Hemorrhoids, Joint pain, Sleep Apnea, cataracts, osteoporosis, diverticuli, low back pain, anemia, sinusitis, allergic rhinitis and testosterone deficiency. Recent surgery for bowel obstruction with wound dehiscence.			1						1	Anaemia; Dehydration; Hydronephrosis; Prostatic disorder; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70089~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARZOS~MERCK & CO. INC.~0981F~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Hospitalisation	Influenza
0265041	10/20/2006	MN	45.0	47		F	10/20/2006	Hives over all her body; received treatment with Prednisone.				Y					Y	10/13/2006	10/13/2006	0		UNK	UNK		None	None			1						1	Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA211AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0265044	10/20/2006	TN	58.0	58		F	10/20/2006	INNOCULATED ON 10/14/2006,11:AM WITH PNEUMOCOCCAL VACCINE(1ST INNOCULATION 1999) AND ANNUAL INFLUENZA VACCINE.  PAIN, SWELLING, AND FEVER BEGAN AT SITE OF PNEUMOCOCCAL INNOCULATION AT 1:00PM.  2:00PM PAIN IN UPPER ARM BECAME INTENSE.  3:OOPM NAUSEA BEGAN.  INGESTED AT 9AM, 220MG OF NAPROXEN.  5OOMG OF ACETAMINOPHEN INGESTED AT 9AM & 1PM.  PATIENT BECAME FEARFUL OF ADVERSE REACTION BEING LIFE THREATENING BECAUSE OF PRE-EXISTING CONDITIONS OF ASTHMA, HYPERTENSION, & OBESITY.  TRIP TO EMERGENCY ROOM AT 4PM.  DECIDED NOT TO WAIT TO SEE PHYSICIAN. NO TREATMENT RECEIVED. RETURNED HOME. VOMITING BEGAN AT 5PM.  PHONED THE PHYSICIAN ON CALL.  SHE PRESCRIBED 25MG PROMETHAZINE SUPPOSITORY TAKEN AT 5:30PM.  VOMITING CEASED WITH MODERATE NAUSEA REMAINING FOR THE NEXT 8 HRS. MOIST HEAT APPLIED TO SHOULDER WHICH HELPED EASE PAIN SLIGHTLY.  400MG OF IBUPROFEN TAKEN ORALLY AT 6:30PM, 11PM, AND 5AM.  INTENSE PAIN LASTED FOR 16HRS.  UPPER ARM REMAINED SWOLLEN, FEVERISH, AND IMMOBILE FOR 4 DAYS.  LEFT ARM STILL HAS LIMITED ROTATION AND MILD PAIN AROUND SHOULDER JOINT. PUBLIC SHOULD BE ALERTED TO EXPECT A MORE SEVERE REACTION WITH A SECOND PNEUMOCOCCAL INNOCULATION.  NO ADVERSE REACTION WAS DISPLAYED WITH THE 1ST INNOCULATION IN 1999 AND NO REACTIONS FROM ANY INFLUENZA VACCINATIONS.				Y					N	10/14/2006	10/14/2006	0		UNK	UNK	3X DAILY 250MG VERAPAMIL 1X DAILY 25MG HYDROCHLOROTHYAZIDE 2X DAILY 220MG NAPROXEN	NONE	ASTHMA, MODERATE HYPERTENSION, OBESITY, OSTEOARTHRITIS			1						1	Hypokinesia; Injection site pain; Injection site swelling; Injection site warmth; Nausea; Pain; Shoulder pain; Vomiting	FLU3~SANOFI PASTEUR~U2180AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1037F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0265045	10/20/2006	WI	2.0	2	.5	M	10/20/2006	2-3 AREA AROUND INJECTION SITE. WARM, RED, AND HARD. NOT TENDER.									Y	10/17/2006	10/18/2006	1		UNK	UNK						1						1	Injection site erythema; Injection site induration; Injection site warmth	FLU3~SANOFI PASTEUR~U2166BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0741F~2~IM~RA~HEP A (VAQTA)~1	USA		Influenza
0265048	10/20/2006	IL	50.0	50		F	10/20/2006	Gave flu vaccinations at my place of employment.  Received shot at 11:30a.  At 2:30p, I began to feel very dizzy and legs and arms became tingly.  Felt disorientated.									Y	10/19/2006	10/19/2006	0		UNK	UNK		None	Allergy to Penicillin			1						1	Disorientation; Dizziness; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0265049	10/20/2006	NY	77.0	76		M	10/20/2006	Approximately 2 hours after recieving vaccine patient reported itching of his right arm which he scratched vigorously.  He then developed redness and swelling below the injection site.  Ice packs applied to area.				Y					U	10/19/2006	10/19/2006	0	None	UNK	UNK	None	None	None			1						1	Injection site erythema; Injection site swelling; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71210~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1040P~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0265050	10/20/2006	NY	20.0	81		F	10/20/2006	Approximately 8 hours after receiving vaccine, patient complained of feeling very tired and weak with joint pain in all four extremities (L>R).  Pain had resolved in all extremities except left arm within 5 days.				Y					U	10/13/2006	10/13/2006	0	None	UNK	UNK	None	None	None			1						1	Arthralgia; Fatigue	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71277~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0265051	10/20/2006	MI	39.0	39		F	10/20/2006	Pt had swelling, redness, and streaking down entire arm to fingers tips, fever, aches, pain. She iced her arm and took Motrin and Benadryl.  She continues to have redness, warmth, swelling, itching and pain a week after vaccination.  She will have a follow up visit with the physician next week.				Y					Y	10/12/2006	10/12/2006	0		UNK	UNK	none	no	no			1						1	Erythema; Pain; Pruritus; Pyrexia; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70277~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0265052	10/20/2006	NC	69.0	69		M	10/20/2006	PATIENT RECEIVED INFLUENZA VACCINE INTRAMUSCULAR LEFT DELTOID ON 10/17/2006.  PATIENT REPORTS HAVING A ITCHY THROAT AND SWELLING OF THE TONGUE A FEW HOURS AFTER VACCINATION.  LATER IN THE EVENING, THE PATIENT EXPERIENCED HIVES ON CHEST, BACK, LEGS, ARMS, NECK, AND FACE.  CONTACTED THEIR DAUGHTER WHICH IS A NURSE AND THE EMERGENCY LINE AT THE LOCAL HOSPITAL WHICH SUGGESTED TAKING BENADRYL.  TALKED WITH PATIENT ON 10/18/2006 CONCERNING REACTION WHICH STATED A DECREASE IN HIVES.  HE PLANS TO CONTINUE TAKING BENADRYL.  STRONGLY SUGGESTED HE FOLLOW UP WITH PRIVATE MEDICAL DOCTOR OR CLINIC.									U	10/17/2006	10/17/2006	0		UNK	UNK	UNABLE TO CONTACT PATIENT	NO	UNKNOWN			1						1	Pharyngolaryngeal pain; Tongue oedema; Urticaria	FLU3~SANOFI PASTEUR~U2178AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265054	10/20/2006	CO	1.99	1	1	M	10/20/2006	20cm x 30cm area of induration, warmth 48 hours after pcv vaccine.  No systemic illness.				Y					U	10/18/2006	10/19/2006	1		UNK	UNK		no	no			1						1	Injection site induration; Injection site warmth	FLU3~SANOFI PASTEUR~u2177aa~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~b08649d~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0265055	10/20/2006	TX	43.0	43		M	10/20/2006	Within about 8 hrs of receiving flu vaccine began to feel weak, achey and feverish; within 12 hrs he broke out with a small red pinpoint sized rash on his trunk; no anaphylactic symptoms experienced; saw physician twice, received medication for symptoms, was ill and missed work 6 days.				Y					Y	10/09/2006	10/09/2006	0		UNK	UNK		stated feeling tired but not moderately or severely ill				1						1	Asthenia; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA213BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0265056	10/20/2006	TX	24.0	24		F	10/20/2006	Within 8 hours of vaccination employee began to experience aching and swelling at vaccine site, swelling spread up shoulder and a small knot formed above clavicle; other symptoms within 24 hourse included fever; no symptoms of anaphylaxis reported; physician seen and diagnosed as local reaction to flu vaccine, prescribed naproxen, symptoms subsided by 10-20-06.				Y					Y	10/06/2006	10/07/2006	1		UNK	UNK		none reported				1						1	Injection site pain; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU213BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0265057	10/20/2006	NC	61.0	63		F	10/20/2006	Pt. called 10-20-06 4:15pm stating that her arm was hurting and that she was experiencing some chills last night and today.  She was taking pain medication Percocet 7.5/325 for another pain condition for her back that she used.									U	10/19/2006	10/19/2006	0		UNK	UNK	Synthroid, Paxil, Percocet, Klonopin, Seroquel	Not available	No allergies according to Patient.  Medical conditions unknown.			1						1	Chills; Pain	FLUX~UNKNOWN MANUFACTURER~2f600911~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0265059	10/20/2006	IA	53.0	53		F	10/20/2006	Patient's right bicep was red, swollen and warm around injection site 2 days after receiving the flu shot.  Patient stated that it was also tender.  She said that she had been taking benadryl and it wasn't helping with the reaction. She was not running a fever.  We had the nurse practitioner look at the arm.  She prescribed Cephalexin just in case it was an infection.									U	10/18/2006	10/19/2006	1		UNK	UNK						1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71213~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265073	10/20/2006	FL	61.0	60		F	10/20/2006	Severe pain in arm, cough, fever, headache, congestion, etc Flu symptoms.									Y	10/09/2006				UNK	PVT	NONE	NONE	NONE	Flu, test subject for the hong kong flu vaccine~Influenza (Seasonal) (no brand name)~~23.00~In Patient		1						1	Cough; Headache; Influenza like illness; Nasal congestion; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0265074	10/20/2006	NJ	1.31	1	.3	M	10/20/2006	Right upper arm inflammation, warm to touch, hardness and bruising. Afebrile. Treating with cool compresses, Tylenol and PO Benadryl.									Y	10/18/2006	10/19/2006	1		PVT	PVT			Peanut Butter, HX petechiae.	~Measles + Mumps + Rubella (no brand name)~1~1.08~In Patient		1						1	Contusion; Injection site induration; Injection site inflammation; Injection site warmth	DTAP~SANOFI PASTEUR~C2489AA~4~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2166AB~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0679F~3~IM~LA~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~8086468~3~IM~LA~PNEUMO (PREVNAR)~1	USA		Influenza
0265076	10/20/2006	MA	26.0	26		F	10/20/2006	Itchy rash over arms, back and legs. Resolved after couple days. Reported 1 week after vaccine given.									Y	10/10/2006				UNK	UNK		No	No			1						1	Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA201AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0265077	10/20/2006	MA	52.0	52		F	10/20/2006	Hypersensitivity reaction, right upper extremity became inflamed after receiving immunization. Reaction resolved by 10/17/06. Evaluated on 10/16/06.									Y	10/13/2006	10/13/2006	0	None	PUB	OTH		None	RA (rheumatoid arthritis) status post methotrexate.			1						1	Hypersensitivity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71216~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~PFIZER\WYETH~0577R~1~~RA~PNEUMO (PNU-IMUNE)~1|TD~MASS. PUB HLTH BIOL LAB~Td153~UNK~~LA~TD ADSORBED (TDVAX)~1	USA		Influenza
0265081	10/20/2006	TX	27.0	26		F	10/20/2006	Swollen right upper arm with fever at site.									Y	10/16/2006	10/17/2006	1	None	OTH	OTH	Zyrtec Singulair Advair	None	Asthma Imitrex Levaquin			1						1	Feeling hot; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0265061	10/21/2006	VA	49.0	49		F	10/21/2006	Received both Fluzone and Pneumovax in top left arm one below the other on 6:45 pm 10/18/06.  At 1 am, I woke up and could not catch my breath. My left Arm hurt very bad, it was hot, swelled, and was sore and same arm broke out in welts below shot area above the elbow on 10/20/06. I took Tylenol every 3.5 hours for pain. The pain was so bad I could not move my arm if the Tylenol was not taken. I felt very congested and tired after the shot. It should be noted my arm hurt badly and I not able to sleep. Today 10/21 6:45 am the pain has lessened but the welts are still on my arm and very hot to touch. There are two welts about the size of a quarter each.  I have had taken many flu shot in the past and never had an allergic reaction. I believe I am reacting to the Pneumovax injection.  I am allergic to several drugs Norvasc Tabs 5 mg, Nifedipine 60 mg.   Currently I am being treated for high blood pressure. I take the following medications:  Lisinopril  5 mg 1 Daily Hychlochlorot 25 mg 1 daily, and for allergies Rhinocort Aqua Spray 32 mcg 1 sprays each nostril 1 daily. In September I was diagnosed with mild sleep apnea. My blood pressure is under control.  My other vitals are perfect. My last blood pressure checked on 06/27/06 and was 132/76. That is about the normal range when it is checked.    This 1.5 past years, I have has many health issue:  July 19, 2005 Surgery for Prolapsed Rectum  Surgery for Abdominoplasty  February 28, 2006  Bladder Surgery.  I was unable to take the  RX pain medications because I felt like I was unable to breath.   I hope this helps your studies on these drugs for allergic reactions. I am fine now. My arm is just a little sore today.  I did not report this to my Doctor. I will tell him about it when at my next appointment on December 18, 2006.									Y	10/18/2006	10/18/2006	0		UNK	UNK	Lisinopril  5 mg 1 Daily Hychlochlorot 25 mg 1 daily, and for allergies Rhinocort Aqua Spray 32 mcg 1 sprays each nostril 1 daily	Currently I am being treated for high blood pressure. I take the following medications:  Lisinopril  5 mg 1 Daily Hychlochlorot 25 mg 1 daily, and for allergies Rhinocort Aqua Spray 32 mcg 1 sprays each nostril 1 daily. In September I was diagnosed with mild sleep apnea. My blood pressure is under control.  My other vitals are perfect. My last blood pressure checked on 06/27/06 and was 132/76. That is about the normal range when it is checked.	I am allergic to several drugs Norvasc Tabs 5 mg, Nifedipine 60 mg.			1						1	Dyspnoea; Feeling hot; Injection site warmth; Pain; Urticaria	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265062	10/21/2006	AK	86.0	86		F	10/21/2006	About 2-3 days later upper left arm very sore,red, & swollen in 3 inch X 3 inch area.  No fever or other Sx.  It hurt too much to lie on it.  Public Health Nurse notified by patient on 10/19/06 and examined left arm with quarter size round erythemic, tender & warm to touch area with a darker dime size area in the center.  Patient's daughter reports today 10/21/06 by phone that soreness & redness is resolving.									Y	10/09/2006	10/12/2006	3	none	UNK	UNK						1						1	Erythema; Injection site warmth; Pain; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U2237AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0320F~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265063	10/22/2006	CA	31.0	31		F	10/22/2006	Six hours after receiving vaccination, I developed a low grade fever, muscle aches, restlessness and vomiting. Symptoms lasted 18 hours and within 24 hours of vaccination completely dissipated.									Y	10/21/2006	10/21/2006	0	None	UNK	UNK		None	Allergy to aspirin, chronic asthma			1						1	Myalgia; Pyrexia; Restlessness; Vomiting	FLU3~SANOFI PASTEUR~21213A17~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265064	10/22/2006	OH	39.0	39		F	10/22/2006	Hoarseness and Shortness of breath.									N	10/21/2006	10/21/2006	0		UNK	UNK	Prevacid, Amitripoline 50mg qpm,	none	none			1						1	Dysphonia; Dyspnoea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70740~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0264540	10/23/2006	TN	12.0	12		F	10/18/2006	9:50 child presented back to clinic c/o chest pain and racing heart rate. HR >150, bp 160/80, RE>20, diaphoretic, clammy, and pale, denies SOB, 9:55 HR >150, BP 190/98, 9:56 EMS arrived, child transported to hospital. Hospital records attached.				Y	Y	1			Y	10/03/2006	10/03/2006	0		PUB	OTH	NONE		Anxiety (panic attacks) per hospital admit record.			1						2	Chest pain; Heart rate increased; Hyperhidrosis; Malaise; Respiratory rate increased; Chest pain; Cold sweat; Heart rate increased; Hyperhidrosis; Hypertension; Pallor	FLUN3~MEDIMMUNE VACCINES, INC.~500434P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500434P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Hospitalisation	Influenza
0265072	10/23/2006	OH				F	10/22/2006	Hives, Itchy.									U	10/22/2006	10/22/2006	0	Hives	OTH	OTH		NONE				1						1	Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70740~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265109	10/23/2006					U	10/16/2006	Seriousness criteria other medically significant (OMIC). Initial report received on 10/12/06 from the vaccine safety information sharing system on behalf of a health care professional. A teenager had received an Influenza vaccine on an unspecified date, and within a few weeks developed acute disseminated encephalomyelitis. The pt did not require any treatment. The vaccine trade name, manufacturer, route and site of administration was not reported. Per the reporter, the health care professional was questioning whether meningococcal vaccine (or any other vaccine) can cause a recurrence of acute disseminated encephalomyelitis (ADEM) (assuming a causal relationship, for the event, which, in his opinion, has not been firmly established). No other information was provided. The recovery status of the pt is unk.				Y					U					UNK	UNK					200602666	1						1	Encephalitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0265114	10/23/2006	PA	0.51	0	.5	M	10/20/2006	Seizure activity x 2 hospitalized given anti seizure medication.  Well child exam of 10/18/06 received from pediatrician.  Hospital record of 10/19-20/06 also received which reveals tonic/clonic seizure activity x2.  Tx'd with Ativan IM and IV as well as Cerebyx.  No further seizures during 1 night admission. Tmax=100'F.  Discharge dx: Seizure Disorder probably 2' to vaccine./pc				Y	Y	2			Y	10/18/2006	10/18/2006	0	Labs significant for blood glucose of 175 upon admission.  CT of brain shows no abnormality.	PVT	PUB						1						1	Convulsion; Hyperglycaemia; Pyrexia; Vaccination complication	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B063AA~3~~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2195AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08657K~3~~RL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0265116	10/23/2006	TN	65.0	64		M	10/21/2006	Dizziness, Weakness, feeling of impending doom, Shaky, tremor like movements. A/O no loss of consciousness, no SOB, pain, nausea, vomiting.				Y					U	10/21/2006	10/21/2006	0	Sent to ER	UNK	UNK	NONE	Recent Root canal	NONE			1						1	Asthenia; Dizziness; Feeling abnormal; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70740~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0265117	10/23/2006	ME	20.0	19		F	10/22/2006	States lightheadedness, feeling flushed, stomach queasy, BP 125/75. Lungs clear bilat, no stridor noted, denies itching, SOB, no local reaction noted at site. States have not eaten all day. Instructed to eat. After eating prolen bar feels better. Instructed to go to ER if symptoms worsen. No changes after eating observed for 20 mins.									Y	10/22/2006	10/22/2006	0		OTH	PVT		NONE				1						1	Dizziness; Flushing; Nausea	FLUX~UNKNOWN MANUFACTURER~70940~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0265118	10/23/2006	CA	78.0	78		F	10/20/2006	Swollen eyes, aching joints especially jaw which made it painful to chew. Throat closing up, swollen tongue symptoms continued next day. Seen by doctor on 10/17 prescribed prednisone. Medication helped, was able to eat something and today does not feel as achy. Extreme achiness, headache, bothered my eyes, some dizziness, persisted for several weeks. Ultimate duration a month. Doctor prescribed  Prednisone. Finally cleared up.				Y					Y	10/11/2006	10/11/2006	0		OTH	OTH	COUMADIN; CALTRATE; Estradiol; OXYTROL	No	Stroke 2 1/2 years ago; Seasonal allergies. Stroke on 4/29/2004			1						1	Arthralgia; Eye swelling; Pain in jaw; Throat tightness; Tongue oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0265119	10/23/2006	MD	59.0	59		M	10/18/2006	Received Flu vaccine  U2178AA  exp 6/30/07, 4 hours later had generalized raised red rash. No itching, SOB etc. During same evening left hand and arm with increased swelling with slight redness, warmth at left deltoid inject site. Itching began 10/18/06 at 3:30pm Medicated with Benadryl PO 25mg now and 25mg at bedtime.									N	10/18/2006	10/18/2006	0		MIL	PUB	Lipitor, ASA.					1						1	Injection site erythema; Injection site oedema; Injection site warmth; Oedema; Pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~U2178AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265120	10/23/2006	GA	82.0	81		F	10/16/2006	Edema from top of arm and elbow warm to the touch.									Y	10/02/2006	10/02/2006	0		OTH	PUB						1						1	Injection site oedema; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70739~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1004D~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265121	10/23/2006	PA	4.0	4		F	10/19/2006	Right arm swollen, red.									Y	10/16/2006	10/17/2006	1		PVT	PVT						1						1	Injection site erythema; Injection site oedema	DTAP~SANOFI PASTEUR~C2649AA~5~~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2239AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0001~4~~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0950F~2~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0265122	10/23/2006	CA	48.0	47		F	10/19/2006	Within minutes of receiving immunization, arm began to tingle and itch. After 1/2 hour, itch progressed to chest, head and back. Had rash on face, arm and chest.									Y	10/18/2006	10/18/2006	0		PUB	PUB		NONE	Allergy to sulfa, shrimp, mild/mod asthma.			1						1	Paraesthesia; Pruritus; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69427~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265123	10/23/2006	TX	22.0	22		F	10/17/2006	Pain in left arm, from injection site down. Dizziness, nausea, stiffness in left arm (injected arm). No local reaction, no redness no knot, no SOB, no hives.									Y	10/17/2006	10/17/2006	0		UNK	UNK	Yasmin, Zoloft, Protonix.	NONE	NONE			1						1	Dizziness; Injection site pain; Musculoskeletal stiffness; Nausea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70384~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265124	10/23/2006	CA	1.05	1	.0	F	10/18/2006	Fever up to 105 deg, rash on left leg advised Motrin for fever, lukewarm baths for fever and Benadryl for rash. Symptoms started 10/15/06.				Y						10/06/2006	10/15/2006	9		PUB	PVT	Amoxil	Resolving Poss. sinusitis.				1						1	Pyrexia; Rash	FLU3~SANOFI PASTEUR~U2174DA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0237F~4~IM~RL~HIB + HEP B (COMVAX)~1|HEPA~MERCK & CO. INC.~0741F~1~IM~RL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~1123R~1~SC~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0265125	10/23/2006	LA	4.0	4		F	10/16/2006	Developed cough that progressed to wheezing and decreasing O0 Sat to 90%.				Y					Y	10/13/2006	10/13/2006	0	Test pending serum Tryptase level/IgE RAST gelatin.	PVT	PVT		Cold	Congenital heart disease.	Anaphalaxis~Hib + Hep B (Comvax)~2~4.00~In Patient		1						1	Cough; Hypoxia; Wheezing	FLU3~SANOFI PASTEUR~U2192AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265126	10/23/2006	GA	3.0	3		M	10/18/2006	10/17/2006 Received flu shot 10/16/06 woke up this am with left arm red and swollen, area the entire upper arm. No fever, site warm to touch, no glands swollen, no tenderness.				Y					Y	10/16/2006	10/17/2006	1		PVT	PVT						1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U2292AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265128	10/23/2006	TX	54.0	54		F	10/17/2006	Pt received pneumococcal Immunization 10/10/06 left arm 10/12/06 c/o 3 red spots on left deltoid. States sore touch. No treatment. Resolved 10/14/2006.									Y	10/10/2006	10/11/2006	1	NONE	PUB	PVT	NONE	NONE	2 pack			1						1	Injection site erythema; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69480~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0877R~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265181	10/23/2006	FL	51.0	51		F	10/19/2006	Had influenza vaccine 4 pneumovax or 10/17/2006 at 11:30am, soreness to arms started 10/17/06. Redness to both arms, 1 3/4 redness to left deltoid arm and 2 3/4 redness to right deltoid area. SX started 10/18/06. Severe headache, hurting down into left ear and jaws bilateral and down into neck. Started today. No relief of symptoms with Tylenol.										10/17/2006	10/17/2006	0		PUB	UNK	Vitamin E, Calcium.	NONE	Allergies to Ibuprofen and Aspirin.			1						1	Ear pain; Headache; Injection site erythema; Injection site pain; Neck pain; Pain in jaw	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70279~5~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1046O~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265183	10/23/2006	IN	72.0	72		F	10/23/2006	Received vaccine 10/18/06 area became reddened et sore, by 10/18/06 area was like an abscess with fluid in it approx walnut sized. Pt expressed pus et blood from injection site on 10/22/2006 estimated about 4 oz, consulted her Dr and was prescribed an antibiotic to start 10/23/06. (Wheal was bout 10mm+).				Y					Y	10/18/2006	10/20/2006	2	NONE	PUB	PVT	Insulin, Amitriptyline, Glucophage, Zocor, Norotin, Lisinopril, Vitamin C and B12, Lasix.		Diabetes			1						1	Fluid retention; Injection site abscess; Injection site erythema; Injection site pain; Urticaria	FLU3~SANOFI PASTEUR~U2239AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265185	10/23/2006	GA	53.0	53		F	10/21/2006	Pt has had an SUT her entire life. She has had 2 episodes in the last 3 weeks that sent her to the ER. On of those episodes occurred after her vaccination. (SVT = Ventricle tachycardia).				Y					N	10/21/2006	10/21/2006	0		OTH	PVT		NONE	SVT tachycardia.			1						1	Condition aggravated; Supraventricular tachycardia	FLU3~SANOFI PASTEUR~U2165EA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265186	10/23/2006	CO	53.0	52		F	10/21/2006	Tightness and burning in chest. Suddenly. 7 hours after injection coughing with small production phlem. 16 hours after burning sinus and eyes and headaches. Benadryl. For 2 hrs hard to breath.									Y	10/19/2006	10/19/2006	0	NONE	OTH	PVT	Bentyl	NONE	IBS			1						1	Chest discomfort; Chest pain; Cough; Eye inflammation; Headache; Sinusitis	FLU3~SANOFI PASTEUR~49281~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265191	10/23/2006	GA	64.0	64		M	10/23/2006	Patient reported that about 2-3 hours after receiving fluzone injection his blood pressure was elevated.  He checked it at home and reported it to be 155/98.  He had been doing yardwork (planting flowers).  He reported that his pulse was elevated at about 105.  He reports that after about 2 hours of elevated blood pressure he stopped the yard work and just rested.  He monitored both blood pressure and pulse for about the next 8 hours, it decreased after about 7 hours and patient reports he went to bed as usual.  The next morning patient states his blood pressure was only a little elevated.  He does suffer from high blood pressure which is normally controlled by medication, and he reports that he did take his medication as usual the evening before the vaccination, and the evening after the vaccination.  He did not seek any medical attention and reported this back to the pharmacy 2 days following the vaccination.  He reports he has received a flu shot every year for about the last 10 years without any problem.									Y	10/21/2006	10/21/2006	0	None	UNK	UNK	Plavix 75mg  Toprol XL 50mg Diovan 160mg Depakote ER 500mg  Keppra 500mg Synthroid 75mcg Aspirin 81mg Folic Acid 800mcg Advair 100/50 Multivitamin	None	High blood pressure Seizures Emphysema			1						1	Blood pressure increased; Condition aggravated; Heart rate increased	FLU3~SANOFI PASTEUR~U2215AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265193	10/23/2006	AL	50.0	50		F	10/23/2006	Patient reported local irritation, swelling and redness and slight fever. Patient reports exceptional tiredness and runny nose. Local reaction continued to worsen with increased soreness and development of knot at site and weakness in the arm.  Reported slight numbness around mouth and lips that increased and was spreading to face.  Reported that she routinely take NSAID.				Y					Y	10/20/2006	10/20/2006	0		UNK	UNK	Aleve daily	None	Patient reported reaction to tuberculosis vaccine.			1						1	Erythema; Fatigue; Hypoaesthesia; Injection site mass; Pain; Pyrexia; Rhinorrhoea; Skin irritation; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA213AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0265194	10/23/2006	MD	29.0	29		F	10/23/2006	Developed severe urticaria starting the evening after administration.									Y	10/19/2006	10/19/2006	0	To see allergist	UNK	UNK	orthotricycline concerta ritalin protonix inh pyridoxime	LTBI ADD GERD	Urticaria to penicillins			1						1	Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA211AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0265195	10/23/2006	GA	56.0	56		F	10/23/2006	SWELLING AT ELBOW, MILD ELBOW EFFUSION, WARMTH, ERYTHEMA AND TENDERNESS TO ELBOW AND FOREARM. NO FEVER OR OTHER SYMPTOMS. PATIENT SEEN AND TREATED AT URGENT CARE CENTER.				Y					Y	10/20/2006	10/21/2006	1	NO TESTS WERE DONE TO MY KNOWLEDGE	UNK	UNK	Cardizem CD, Hydroxyzine, Lotrisone lotion, Flexeril, Xenical, Ambien, Miralax, Lodrane 24hr, Lortab, Premarin, Effexor XR 150mg	no acute illness	HTN, Hormone therapy, Insomnia, Pulmonary emolism, Atrial Fibrillation, Depression, Depression and Anxiety, Tinea pedis, back pain, Myalgia. Allergy to Neurontin, Ciprofloxacin, Methadone			1						1	Erythema; Feeling hot; Joint effusion; Joint swelling; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71355~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0391F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0265196	10/23/2006	MD	61.0	61		F	10/23/2006	Patient had symptoms of racing heart and increased blood pressure approx 1 hour after the pneumovax vaccine. Patient went to emergency room and was treated for BP 155/100 to 160/112 and HR 100-110. Vaccine injection site was warm, swollen and red on back of left arm at SQ injection site. Patient had EKG that was normal and told to watch back of left arm. Patient returned to ER next day for continuing elevated BP. Patient diagnosed with an inflammatory hypersensitivity reaction over SQ site that covered the span of the back of the left arm and told to watch area, no antibiotic prescribed. No medication needed for elevated BP, told to see primary physician regarding BP levels.				Y					Y	10/20/2006	10/20/2006	0	EKG normal	UNK	UNK	Claritin	None	Demoral, Lidocaine			1						1	Blood pressure increased; Heart rate increased; Hypersensitivity; Injection site erythema; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA222AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0352F~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0265197	10/23/2006	WI	45.0	45		F	10/23/2006	Per ER diagnosis:  Cellulitis in right deltoid area two days post vaccination.  Injection site was purple; red wheal, 2-inches in diameter formed around the purple area.  Warm to touch.  Increased pain (touch and movement).  Elevated temperature=101 degrees Farenheit.  Treatment:  Erythromycin 333 mg. t.i.d. X 10 days; Vicodin PRN.				Y					Y	10/19/2006	10/21/2006	2		UNK	UNK	Metformin, Singulair, Lescol, Aleve		PCN, ASA			1						1	Cellulitis; Injection site erythema; Injection site reaction; Injection site warmth; Pain; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~02216AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0391F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0265202	10/23/2006	MS	23.0	23		F	10/23/2006	PT IS NURSE AT OUR HOSPITAL, CAME TO INF. CONTROL FOR INFLUENZA VACCINE AT 1300.  REC'D VACCINE WHICH SHE HAS TAKEN EVERY YEAR FOR THE LAST 4-5 YEARS AND NEVER HAD A PROBLEM. APPROX. 5-10 MINUTES AFTER GETTING THE SHOT SHE REPORTED TO A COWORKER THAT SHE WAS HAVING TROUBLE GETTING HER BREATH.  tHE COWORKER BROUGHT HER TO THE ER IMMEDIATELY WHERE SHE WAS FOUND TO BE IN EXTREME RESP. DISTRESS WITH AUDIBLE WHEEZING AND AN INITIAL OXYGEN SAT OF 85%.  SHE WAS TREATED WITH CONTINUOUS NEBULIZERS, XOPENEX (SHE TOOK 4 PUFFS FROM HER MDI ENROUTE TO ER), ALBUTEROL AND RACEMIC EPINEPHRINE.  SHE REC'D 0.4 EPINEPHRINE SUB Q AND SOLUMEDROL 250MG IV.  SHE IMPROVED SOMEWHAT BUT HAD TO TRANSFERRED TO A PULMONOLOGIST AND AN ALLERGIST.  THEY BOTH TOLD HER THEY BELIEVED THE REACTION WAS FROM THE FLU SHOT--NOT HER ASTHMA.  SHE IS A NEWLY DIAGNOSED ASTHMATIC AND WAS HOSP. ABOUT 2 MOS PRIOR TO VACCINATION WITH ASTHMA. INCIDENTLY, SHE HAD STOPPED TAKING HER SINGULAIR ABOUT ONE WEEK PRIOR TO VACCINATION AS ORDERED.				Y	Y	3			Y	10/19/2006	10/19/2006	0		UNK	UNK	XOPENEX INHALER	NEW ONSET ASTHMA 2 MOS PRIOR TO VACCINE. HAD D/C SINGULAIR ONE WEEK PRIOR.  STATED CHEST FELT TIGHT IN AM.  DID NOT REPORT THIS PRIOR TO VACCINATION.	PREMIE, HAD ASTHMA UNTIL AGE 3,  NO PROBLEMS AGAIN UNTIL 2 MOS AGO WHEN SHE WAS HOSPITALIZED WITH ASTHMA.			1						1	Dyspnoea; Hypoxia; Respiratory distress; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70737~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0265203	10/23/2006	CO	52.0	52		F	10/23/2006	Individual called today to report a reaction to her flu shot 2 days ago. She noticed her heart pounding approx. 5 hours after her flu vaccine. She then began brief periods of shaking over the next 2 hours. Sometimes the shaking began in her thighs and moved upward to her shoulders. Other times the shaking began at the top of her body and moved to lower extremities. She describes it as being intense enough to shake her bed and almost seizure-like. The episodes lasted approx 1 min each. Her temperature was 98.1 F. Her husband was with her and they did not seek emergency help. The following day her temperature was 99.6 F and she had a headache, but had no further episodes of shaking. No sore throat or other respiratory symptoms were experienced. 2 days following the flu shot she felt her health was back to normal. She has had many flu shots in the past. She was advised to report these symptoms to her physician and to consult him regarding next year's flu shot.									Y	10/21/2006	10/21/2006	0	none	UNK	UNK	Cholestermine Citrucel	None	None			1						1	Headache; Heart rate increased; Pyrexia; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~206BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0265204	10/23/2006	FL	37.0	37		F	10/23/2006	Fluzone administered on 10/20/2006 - L deltoid.  Developed L arm pain.  In the evening had muscle aches in cheat and arms. 10/21/2006 had R sided upper lip swelling, aches and chills, the L sided upper lip swelling in pm. Severe difficulty moving L arm and generalized weakness. 10/22/06 Decreased lip swelling, R eye swollen, Decrease in body aches. 10/23/06 lower lip swollen, but is feeling better.									Y	10/20/2006	10/20/2006	0	none	UNK	UNK	Unknown	None	Cystic Fibrosis			1						1	Asthenia; Chills; Eye swelling; Face oedema; Injection site pain; Myalgia; Pain	FLU3~SANOFI PASTEUR~U2197AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265205	10/23/2006	MI	86.0	86		F	10/23/2006	Patient received the flu vaccine without complications on 10/20/06 at an offsite clinic.  Nothing stood out in my mind.  Patient presented with bruising on Monday 10/23/06.  The pharmacist who viewed the site called me.  Said that there was significant bruising below the site of injection.  The pharmacist said she could view where I injected her, it was in the deltoid muscle, and the bruising was lower then the site and down to her elbow.  Patient also brought it to our attention then that she was on plavix.  We called her doctor, no answer.  We instructed her to go to the emergency room.  I did a follow up call with her latter on 10/23/06 and she said she did see her doctor, that there was no infection and that it would take time to clear up.  There is minimumal discomfort and she is able to move her arm freely.  I told her I would follow up with her on Tuesday 10/24/06.  When I talked with her in the morning trying to assess what was going on she seem conherent and able to answer all of my questions without problems.  When I called to check on her she seemed out of it and had no idea who I was.  I will continue to follow up.				Y					U	10/20/2006	10/23/2006	3		UNK	UNK	Plavix, ASA 81mg rest	none				1						1	Contusion	FLU3~SANOFI PASTEUR~u2256aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265206	10/23/2006	WA	4.0	4		M	10/23/2006	L arm sore, fever 104 0ne day, emesis.									Y	10/20/2006	10/20/2006	0		UNK	UNK						1						1	Pain; Pyrexia; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21Bo70AA~4~IM~RA~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~EVANS VACCINES~71034~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~AC21BO0AA~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1047R~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~BO867720~1~IM~LA~PNEUMO (PREVNAR)~1	USA		Influenza
0265208	10/23/2006	PA	40.0	40		F	10/23/2006	2 hours post vaccination, she developed lower back pain, followed shortly with a persistant cough, within the next hour both eyes swelled shut with matter developing in the eyes. The back pain grew more intense with hives following and a fever of 99.1 degrees. Several hours after the vaccination, she complained of constricted breathing both in the lungs and tightness around the throat. Also noted was hoarseness in the voice. She went to a local medical clinic where a Physician's Assistant declared that she developed an allergic reaction to the (protein)in the flu vaccination and he prescribed Zyrtec for the symptoms. Complete resolutions of the symptoms with treatment occured after 48 hours.				Y					Y	10/18/2006	10/18/2006	0	N/A	UNK	UNK	None	None	Sulfa Allergy			1						1	Back pain; Cough; Dysphonia; Eye discharge; Hypersensitivity; Pyrexia; Throat tightness	FLU3~SANOFI PASTEUR~u2215aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265211	10/23/2006	MS	33.0	33		F	10/23/2006	RIGHT ARM IS EXTREMELY SORE AND CRAMPING ALL THE WAY DOWN (MAINLY IN THE UPPER ARM).  FEELS AS THOUGH IT IS BRUISED AND HAS FEVER IN A 4 TO 6 INCH DIAMETER AROUND SHOT AREA, AS WELL AS HIVES (RAISED WITH WHELPS, ITCHING AND REDNESS).  WHOLE UPPER ARM IS SORE TO TOUCH.  FIRST NOTICED REDNESS & CRAMPING 10-23-06 8:00 AM.  FIRST NOTICED SORENESS 10-20-06 6:00 PM.  EXTREME SORENESS NOTED 10-21-06 2:00 PM. EXTREME SORENESS IS GETTING BETTER NOW (10-23-06 10:15 PM), BUT IS STILL VERY SORE.									U	10/20/2006	10/20/2006	0		UNK	UNK	ALSO RECEIVED B-12 SHOT SAME DAY IN RIGHT HIP AREA ALONG WITH LISTED IN NO. 10	NO	IRRITABLE BOWEL SYNDROME			1						1	Contusion; Erythema; Injection site warmth; Muscle spasms; Pain; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0247682	10/24/2006	CA	57.0	56		F	10/16/2006	Noted tender, enlarges supra clavicular lymph node on right side, day after flu shot in right arm. Itching and redness also noted. Enlarged lymph node on right side, day after flu shot in right arm. Itching and redness also noted. Enlarged lymph node last year also. No itching or redness. On this date, condition is the same with swelling in are of affected node.									Y	10/13/2006	10/14/2006	1		PVT	PVT	Estradiol,Protonix			Same~Influenza (Seasonal) (no brand name)~1~55.00~In Patient		1						2	Erythema; Injection site oedema; Lymphadenopathy; Pruritus; Tenderness; Vaccine positive rechallenge	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA220BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA		Influenza
0265223	10/24/2006	IA	3.0	3		F	10/18/2006	Severe leg pain, refusal to walk, increased CK in blood, hematuria. Summary: Previously healthy almost 4 yr old presented to pediatrician 3 days S/P Fluzone injection on 10/14/06 with c/o pain and refusal to walk.  Vomited the night before.  Admitted for observation to R/O Guillian-Barre vs. acute myositis.   Discharged 1 day later. No D/C summary was written.  F/U visit to PCP on 10/25/06 with  DX: myositis following an influenza vaccine.  Energy and activity level now normal.  Urinating well.  Status: Resolved./pc					Y	1			Y	10/14/2006	10/16/2006	2	Increased CK, Myoglobin in urine pending.  10/1706: UA was positive for hazy, brown urine with high leukocytes, protein, blood, WBCs, and amorphous matter.  Urine myoglobin was high.  10/25/06:Urine dipstick was WNL with pH of 6 and SG of 1.020.	PVT	UNK						1						1	Blood creatine phosphokinase increased; Difficulty in walking; Haematuria; Hypokinesia; Myoglobinuria; Myositis; Pain; Urine analysis abnormal; Vaccination complication; Vomiting	FLU3~SANOFI PASTEUR~U2192AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0265225	10/24/2006	ID	65.0	65		F	10/12/2006	On Wed 10/11 had itching on left arm, beginning in the morning. on 10/12 had hive all over left arm on 10/13 noticed hives on right arm. Has not called MD has not taken any meds at time of report.									Y	10/09/2006	10/11/2006	2		PUB	PVT	Thyroid	NONE	NONE		WA062153	1						1	Urticaria	FLU3~SANOFI PASTEUR~U2240AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1047P~1~IM~LA~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~0621F~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0265226	10/24/2006	AZ	5.0	4		F	10/19/2006	4x3.75 erythema on left lateral arm, cellulitis area receiving warm compress, and antibiotic Omnicef.									Y	10/16/2006	10/16/2006	0		PVT	PVT		NONE	Allergy to PCN			1						1	Cellulitis; Injection site erythema	FLU3~SANOFI PASTEUR~U2193AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265227	10/24/2006	OH	48.0	48		F	10/20/2006	Noticed swelling and redness around injection site (approx size of 50 cent piece) within 24 hours. Had headache and nausea about 48 hours following injection which lasted for 24 hours. Feels completely fine today (10/20). No treatment required.									Y	10/14/2006	10/15/2006	1	NONE	PVT	OTH	OCP, Kelp, Ibuprofen,	NONE	Allergic to PCN, any narcotic itching, bee stings, latex, daughter can not take tetanus.			1						1	Headache; Injection site erythema; Injection site oedema; Nausea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71210~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265228	10/24/2006	CA	31.0	31		F	10/11/2006	Arm was hurting one hour after shot was given, pt developed hives and itching 6 hours later. Pt saw PCP next day at 4pm and received Decadron shot, prednisone and Atarax.				Y					Y	10/09/2006	10/09/2006	0	NONE	OTH	OTH	Multivitamins, B12, Calcium, Vit C, Glucosamine, Cranberry, Prevacid, Effexor.	NONE	Sulphanomide			1						1	Injection site pain; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2240AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265229	10/24/2006	FL	29.0	29		F	10/20/2006	Both arms started hurting at 3:30pm by 11:30pm she was weak, dizzy and her arms aches. Temp 102. Awoke at 3am with chills and severe body ache, nausea, no vomiting. Had rabies vaccine in veterinary school in 2000. Does not know brand. Only SX was headache, 10/19/06 pt got severe stiff neck and headache 10/13/06 about 10pm lasted 24 hours and disappeared spontaneously.									Y	10/11/2006	10/11/2006	0		PVT	PVT						1						1	Asthenia; Chills; Dizziness; Headache; Musculoskeletal stiffness; Nausea; Pain; Pyrexia; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69240~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265230	10/24/2006	NY	72.0	72		M	10/20/2006	He had an influenza vaccine on the right arm on 10/13/06 and a Pneumovax on the left arm. He had a previous pneumovax in 994 without any difficulty. The day following this injection, his left arm became more swollen over the posterior medial aspect extending down to the forearm. The arm was itchy. he did not have any face or throat itchiness or rashes. He called the ER and they advised him just to monitor the situation. Today he fells the arm is better and the swelling is going down. Itching is slight, but resolving. The pt as outlined before had a fall with a fracture of the left clavicle, which has been treated conservatively. He has no other specific complaints.									Y	10/13/2006	10/13/2006	0		PVT	UNK		NONE				1						1	Injection site oedema; Pruritus	FLU3~SANOFI PASTEUR~201AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749F~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265231	10/24/2006	MN	52.0	52		F	10/18/2006	Erythema, body aches, fever to 99.2									Y	10/16/2006	10/17/2006	1		PVT	PVT	Aleve, ASA, Byetta, Calcium with Vit D, Fish oil.		Diabetes, Hyperlipidemia, Benign essential hypertension.			1						1	Erythema; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2257AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1007P~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265232	10/24/2006	MA	66.0	65		F	10/19/2006	Tongue swelling, difficulty breathing, needed Benadryl Prednisone, Albuterol.				Y					Y	10/18/2006	10/18/2006	0		PVT	PVT	Decadron, Biaxin, Pirbuterol.		Seasonal allergies.			1						1	Dyspnoea; Tongue oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA2138BA~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0265233	10/24/2006	TX	69.0	69		F	10/19/2006	Right arm could not be lifted, front, back, or up. That lasted until the following week. Still have trouble lifting anything or raising arm. Hurts right in the shoulder and sometimes to the neck. Mostly still can't move without pain. 05-FEB-2010: P. shot given high on right shoulder, still causing pain when raised to side. Painful most of time. Went to MRI fluid on bursa. 2/1/10									U	10/05/2006	10/05/2006	0		OTH	UNK	ERYTHROMYCINE, MORPHINE	NONE	Morphine, Codeine, IVP			1						1	Bursa disorder; Injected limb mobility decreased; Neck pain; Nuclear magnetic resonance imaging; Pain; Pain; Shoulder pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265234	10/24/2006	HI	2.0	2	.1	F	10/19/2006	Given Varivax, Hep A and Fluzone 10/10/2006. Shingle like rash downL5-S1 dermatome about 48 hours later. Have HX of previous chicken pox.									Y	10/10/2006	10/12/2006	2		PVT	PVT	Poly Vi Flor Chew tabs.	NONE				1						1	Herpes zoster; Viral infection	FLU3~SANOFI PASTEUR~U238AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0741F~2~IM~LL~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~0245F~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0265235	10/24/2006	FL	0.93	0	.9	F	10/19/2006	Infant developed hives over entire body several hours after vaccine. MR received from hospital which documents three separate ER visits (10/17,10/18, and 10/20/2006) for generalized welts over the childs body, which began on the day of Flu vaccine.  Initially thought to be an allergic reaction to Augmentin, which the child was taking for otitis media and an URI(resolved). Augmentin was stopped 10/17/06 but welts persisted despite tx. with Benedryl and Decadron IM. Third ER visit on 10/20 resulted in tx with Benedryl and Solumedrol IV. Dicharged home to F/u with PCP. Dicharge DX: Erythema Multiforme, allergic reaction with rash.				Y					U	10/17/2006	10/17/2006	0		PVT	PVT	Augmentin	Recovered from otitis media, URI	GERD			1						1	Erythema multiforme; Hypersensitivity; Rash; Urticaria	FLU3~SANOFI PASTEUR~U2175GA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265236	10/24/2006	TX	30.0	30		F	10/17/2006	30 minutes after taking flu shot and 2 Tylenol ears flushed, neck started itching no shortness of breath, cool compress applied, 30 min later creases of both arms red, no itching ice pack applied, 30 mins later, ear redness, redness on neck gone. 45 mins later took 50 mg Benadryl 1 hour later no itching or redness.									Y	10/17/2006	10/17/2006	0	NONE	PUB	PVT	BCP	NONE			TX06069	1						1	Erythema; Flushing; Pruritus	FLU3~SANOFI PASTEUR~U2239AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265237	10/24/2006	ID	48.0	48		F	10/18/2006	Bruise, hot to touch, lump and Ibuprofen, heat.									Y	10/16/2006	10/16/2006	0		UNK	UNK		Sinus, URI	NONE			1						1	Contusion; Injection site mass; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA2086A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0265238	10/24/2006	CA	72.0	72		M	10/14/2006	My head/brain not working right experiencing much confusion was spacey, light headed, dizzy. Legs extremely weak. On 10/13/06 legs were twice as weak-came close to falling that day. Legs were actually trying to collapse.				Y				Y	N	09/29/2006	09/29/2006	0		PVT	PVT	Fosamax, spirolastone, Dioron, Bupropion, buspirone, Labothroid.		Orthostatic tremors, cardiomyopathy, osteoporosis.			1						1	Asthenia; Confusional state; Dizziness; Thinking abnormal	FLU3~SANOFI PASTEUR~U2177AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0265239	10/24/2006	GA	4.0	4		F	10/19/2006	Buttocks and lower extremity purpura rash with angioedema, arthritis symptoms BL ankles. child also received Zithromax antibiotic and Lodrane D same day as flu shot.				Y					Y	10/16/2006	10/17/2006	1	UA showed proteinuria. symptoms resolved with prednisone treatment.	PVT	UNK		Right otitis external, URI				1						1	Angioneurotic oedema; Arthritis; Proteinuria; Purpura	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70280~1~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0265273	10/24/2006	CA	34.0	33		M	10/24/2006	High Fever (103-104 F), redness and extremely sore.  Left deltoid region for 4 days, hospitalized for 4 days which cost me $19,100.00 and I don't have any health insurance. I went to one of the flu shot camps on 3rd October 2006 to take the flu shot because the flu season just began.  I went there and filled out the form and ready to take flu shot when administering nurse offered if I would also like to take a pneumonia shot which cost me $40 nd total of $65 including flu shot.  But I was not aware that this pneumonia shot will cost me thousands of dollars.  In the evening of the same day I started to feel little achy and getting little temperature.  But next day in the morning I had a fever about 103 F and body was aching which prompted me to go to the emergency room.  I went there and after few hours of diagnostic and few blood tests they admitted me to the emergency room and started IV.  At this time, my left upper arm was all red and sore that one cannot even touch that part of the hand.  I stayed in the hospital for 4 days because of this pneumonia shot which nurse offered.  Doctor said at the hospital that because of the pneumonia shot there is an adverse effect which kept me in the hospital  for 4 days.  I am only 34 years old and doctor was surprised that why I would need this shot.  He said this shot is only for person above 65 years of age.  I do not have any kind of health coverage and now the hospital bill is $19,100.60.  My income is very low to pay bill.  Now who is responsible for such an event?? Drug store, manufacturer of the vaccine, or the Nurse who offered it?? Hospital MR received which revealed a previously healthy 33 yr old man who presented to the ER with fever, muscle aches, redness, swelling and pain at the site of his Pneumovax.  Admission H&P shows symptoms are consistant with cellulitis, but underlying abcess needs to be ruled out.    Infectious disease consult with the following impression: 1) Fever and leukocytosis 2) Systemic reaction to Pneumococcal vaccine 3) Local reaction and local cellulitis to the injection site 4) Allergic reaction with small hives noted. Treated with antibiotics and steroids. Discharge Summary received. By 3rd hospital day patient was afebrile, no swelling or tenderness, minimal erythema. Discharged home on prednisone to F/U in one week if any problems. DISCHARGE DIAGNOSIS: Adverse reaction to pneumococcal vaccine, local reaction resolved.					Y	4			Y	10/03/2006	10/03/2006	0	LABS and DIAGNOSTICS: WBC's 25.7 upon admission down to 12.3 three days later on antibiotics.  CT of left brachium reveals No Abscess, fluid collection, or mass identified.	OTH	PVT			none noted			1						1	Cellulitis; Erythema; Hypersensitivity; Injection site pain; Injection site reaction; Leukocytosis; Myalgia; Pain; Pyrexia; Swelling; Unevaluable event	FLU3~SANOFI PASTEUR~U218AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0391F~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0265274	10/24/2006	IL	66.0	66		F	10/24/2006	Approximately 10:30 am on 10/24/2006 injected patient with Fluzone 2006 0.5 ml. Approximately 10:45 am patient left building felt fine.  Approximately 11:20 am patient returned complain of swollen lip, throat swelling.  Approximately 11:25 am gave Epi pen injection called medical doctor to inform.  Approximately 11:30 am Emergency Medical Technician took blood pressure 168/108 gave them Epi pen and left to emergency room. observation stay on 10/25/2006 experienced swelling of lips and inability to speak. Symptoms began approximately 45 minutes prior to arrival. No difficulty breathing. No difficulty swallowing. Symptoms began 20 minutes after vaccine. PMH:lip swelling from oral AB once in the past. IN ER some slight swelling of lips. some swelling of the arms but no rash or pruritis.  RX with Solu-Medrol and Benadryl. Per annual follow up: Pt was kept overnight at hospital for observation. Spoke to pt after she was released and was doing well.				Y	Y	1			Y	10/24/2006	10/24/2006	0	Labs: Chem: WNL, glucose 152 CBC with diff: WNL  Myoglobin 87.2 BNP: <5.0 CPK MB <1.0 CXR: no acute infiltrate	OTH	PUB	Avalide, Aspirin, PREVACID, ALLEGRA					1						1	Pharyngeal oedema; Swelling face	FLU3~SANOFI PASTEUR~U2257AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0265276	10/24/2006	CA	38.0	38		F	10/24/2006	Pt reported rash (dark spots on thorax, abdomen, arms, and shoulder, beginning 10-12 hours after receiving Influenza vaccine at work in hospital on 10/20/2006.									U	10/20/2006	10/20/2006	0		PUB	PUB						1						1	Rash; Skin discolouration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71216~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265279	10/24/2006	NH	73.0	73		F	10/24/2006	Chills and fever, right elbow red swollen.									Y	10/20/2006	10/20/2006	0		PVT	UNK		Post pneumonia 9/26/06				1						1	Chills; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U2195AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1044P~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265280	10/24/2006	MA	1.27	1	.3	F	10/24/2006	Diffuse erythematous macules/papular rash with congestive and low grade fever.  10 days after immunizations.										10/12/2006	10/22/2006	10		PVT	PUB	NONE					1						1	Erythema; Pyrexia; Rash maculo-papular	FLU3~SANOFI PASTEUR~U2175GA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE830AA~4~IM~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0615F~1~IM~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0265281	10/24/2006	MO	4.0	4		M	10/24/2006	7 cm X 7cm warm, redden area to left deltoid.  No treatment.				Y					Y	10/18/2006	10/21/2006	3		PVT	PVT	NONE	NONE	NONE			1						1	Erythema; Injection site warmth	DTAP~SANOFI PASTEUR~C2649AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2166LA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0240~4~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0707F~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0265282	10/24/2006	MD	50.0	50		F	10/29/2006	Noted bruised and red, swollen, tender area mid right deltoid warm and painful to touch.									U	10/23/2006	10/24/2006	1	NONE	PVT	UNK	heparin 5000u sq twice a day, Lantus 45u daily every am, ASA 81 mg daily, Lexapro 10mg by mouth daily, Skelaxin 800mg daily by mouth, SINGULAIR 10mg by mouth daily, SPIRIVA inhaler daily, ADVAIR 100/50 puff one twice a day, PROTONIX 40mg by	cellulitis right foot, IDDM	migraine, depression, hypertension, asthma, UTI, IDDM since 23 years old, arthritis, legally blind left eye, partial blind right eye.			1						1	Contusion; Erythema; Hyperaesthesia; Injection site warmth; Pain; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U21650A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0674F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265283	10/24/2006	MI	29.0	29		F	10/23/2006	60 mm round, red area, sore and hot to touch.  Oral temperature 97.8, no other signs and symptoms.									Y	10/18/2006	10/20/2006	2	NONE	PVT	PVT	Unknown	NONE	Unknown			1						1	Erythema; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA221BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0265290	10/24/2006	MD	5.0			M	10/24/2006	Patient develop fever of 101.9 F 3 days after receiving FluMist which progess to peak of 104.4 5 days after FluMist administration.  Patient tx'd with Motrin.				Y					Y	10/13/2006	10/16/2006	3	None discussed	UNK	UNK	Not Known	None noted.	Unknown.			1						1	Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500436P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0265291	10/24/2006	NJ	38.0	38		F	10/24/2006	Pt. awakened 10/24/06 @ 5am. After shower body was more red than usual.  On drive to work, pt felt uncomfortable, felt heat and pressure on chest and back. Skin felt itchy. At work, coworkers advised her she was red. Called office at 8:15am. No c/o difficulty swallowing, no coughing. Advised to see MD now. Temp. 98.6, P 72, B/P 117/70. MD administered Kenalog IM, told to take Benadryl po at home and if symptoms worsened or not resolving to go to ED.				Y					N	10/23/2006	10/24/2006	1		UNK	UNK						1						1	Discomfort; Erythema; Feeling hot; Pruritus; Sensation of pressure	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA218BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0265293	10/24/2006	IA	37.0	37		F	10/24/2006	vesicular reaction at influenza vaccination site				Y					U	10/20/2006	10/21/2006	1	none	UNK	UNK	Lexapro  BCP   Ativan	none	allergies  amoxicillin sulfa			1						1	Injection site vesicles	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71034~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0265295	10/24/2006	MD	67.0	67		F	10/24/2006	Client c/o swelling right after injection and it decreased the next day, however c/o increased pain at sight and stated sometime last week the pain went down her left arm and she had numbness in her fingers on her left hand occasionally. Client encouraged to call her PMD.Injection was given with a biojector.				Y					U	10/12/2006	10/12/2006	0		UNK	UNK		none				1						1	Hypoaesthesia; Injection site pain; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69426~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0265296	10/24/2006	TX	50.0	41		F	10/24/2006	Patients arm was swollen,she also had arm pain,fever,chills nausea,and headache.  Her MD said she probably had already been previously exposed to a bug.  She is getting better				Y					Y	10/21/2006	10/21/2006	0		UNK	UNK						1						1	Chills; Headache; Nausea; Pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U2213AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1036P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0265300	10/24/2006	ID	36.0	36		F	10/24/2006	5 minutes after injection, itchy, hot and noticed rash and hives on arms, face. Hands started to swell.  Went to pharmacy and took 25mg of Benadryl.									Y	10/24/2006	10/24/2006	0		UNK	UNK	Aleve	None	None			1						1	Feeling hot; Oedema peripheral; Pruritus; Rash; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA208BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0265301	10/24/2006	NJ	30.0	30		F	10/24/2006	Took flu shot in January 1993, and was hospitalized with Guillain-Barre Syndrome in February, 1993. Acute phase lasted 4 months, with total paralysis. ICU, ventilation, and step-down for 4 months, and then rehabilitative care for 2 months. Took immunoglobulin, steroids and plasmapheresis treatments. Per 60 day follow up: I contracted GUILLAIN-BARRE syndrome as a result of recv'g the vaccine. The residuals of total paralysis include numb legs and feet & other issues. We need a disclaimer on the flu shot form!			Y	Y	Y	180	Y	Y	N	01/10/1993	02/03/1993	24	See above	UNK	UNK	none	none	none			1						1	Blood product transfusion; Guillain-Barre syndrome; Hypoaesthesia; Intensive care; Mechanical ventilation; Paralysis; Plasmapheresis; Vaccination complication	FLUX~UNKNOWN MANUFACTURER~Unknown~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0265303	10/24/2006	PA	45.0	44		F	10/24/2006	Developed nasal stuffiness in one week, followed by development of nasal hemangioma requiring removal as an outpatient				Y					Y	10/16/2005	10/27/2005	11		UNK	UNK	None	None	None			1						1	Haemangioma; Nasal congestion	FLUN3~MEDIMMUNE VACCINES, INC.~500426P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0265304	10/24/2006	WI	4.0	4		M	10/24/2006	UPPER LEFT ARM IS SWOLLEN,RED,HOT,AND TENDER. THE ENTIRE UPPER ARM IS SWOLLEN.									Y	10/23/2006	10/23/2006	0		UNK	UNK	SINGULAR 4 MG DAILY,ALBUTEROL NEBS, PULMICORT NEBS	COUGH,LUNGS WERE CLEAR,NO WHEEZING	ASTHMA, ALLERGIC TO TREES,TREE NUTS,PEANUTS, DOGS, CATS, DUST MITES,RAGWEED,MOLDS			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	DTAP~SANOFI PASTEUR~02627AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2165BB~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~40991~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0707A~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0265311	10/25/2006	OH	5.0	5		F	10/24/2006	Received Flumist 10/20/2006. 10/22/2006 developed headache and fever. 10/23/2006 developed nose bleed only symptomatic treatment needed but sent home from school and mom was quite upset.				Y					Y	10/20/2006	10/21/2006	1	NONE	PVT	UNK		NONE	NONE			1						1	Epistaxis; Headache; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500432P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0265312	10/25/2006	NJ	27.0	27		F	10/13/2006	Telephone interview 10/12/06. Patient reports onset of symptoms began within the hour. Redness and swelling at right arm. Symptoms progressed. Fever greater than 102, nausea, vomiting, dizziness, and arm swelling to twice its size. ER visit; received steroids and Benadryl. On exam 10/13/06, pink area on right arm approximately 6x4. Not swollen or arm. No open areas noted. Patient reports not feeling 100% without specific complaints. On interview, patient reports fever around 101 and nausea and vomiting and arm swelling.				Y					Y	10/03/2006	10/03/2006	0	Blood cultures and many blood tests. Patient told tests negative; results unknown.	PUB	PVT	Yazmin; Donperidon	NONE	Gastroparesis; Endometriosis			1						1	Dizziness; Erythema; Nausea; Pyrexia; Swelling; Vomiting	FLU3~SANOFI PASTEUR~U2204AA~5~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0391F~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0265313	10/25/2006	CA	43.0	43		F	10/20/2006	Sudden onset of hot rush immediately after flu-shot injection to left deltoid, followed by feeling of diaphoretic with palpitation, heart rate increase 130 sinus tachycardia, no ectopy.				Y					Y	10/19/2006	10/19/2006	0	NONE	PUB	PVT			rheumatoid arthritis			1						1	Hyperhidrosis; Palpitations; Tachycardia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA216BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0265315	10/25/2006	FL	49.0	49		F	10/25/2006	18/06HIVES, HOARSENESS WEDNESDAY 10/18/06 HIVES, TORSO, BENEDRILL 2 EVERY 3.5 HOURS X2 THURS. 10/19/06                           X4 FRIDAY 10/20/06                     EARS, ARMS X4 SAT.   10/21/06                            LEGS, LIP, HOARSENESS  X4 SUN    10/22/06     SAME AS ABOVE  X5 MON    10/23/06     BENEDRILL X1 TUE    10/24/06     NO SYMPTOMS									Y	10/17/2006	10/18/2006	1		UNK	UNK	INSULIN SYNTHROID ALTACE TOPROL	NONE	DIABETES INSULIN DEPENDENT ALLERGIC: PENNICILLIN/ SHELLFISH	YES~Influenza (Seasonal) (no brand name)~1~0.00~In Patient		1						1	Dysphonia; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70279~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265316	10/25/2006	TX	45.0	45		F	10/25/2006	WITH IN 24 HOURS LARYNGITIS WITH IN 36 HOURS UPPER RESPIRATORY INFECTION INCLUDING INABILITY TO EQUALIZE EARS, HEARING AFFECTED ADDED TO SYMPTOM WITH IN 48 HOURS FEVER, DEEP COUGHING, WHEEZING DIFFICULTY BREATHING  ADDED TO SYMPTOMS. WILL REQUIRE DOCTOR VISIT TO ELIMIANTE SECONDARY BACTERIAL INFECTION.				Y					N	10/21/2006	10/22/2006	1		UNK	UNK	DETROL LA NEXIUM WELLBUTRIN XL	NONE	NONE			1						1	Bacterial infection; Balance disorder; Cough; Dyspnoea; Hypoacusis; Laryngitis; Pyrexia; Upper respiratory tract infection; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0265317	10/25/2006	MD	52.0	52		F	10/25/2006	Fluvirin administered via Bioject injection device on 10/24/06.  Ct. returned to clinic on 10/25/06 to present with contusion 105 mm (w) by 70 mm (l).  Ct. state L upper arm was sore from the time she recieved the vaccination. In the evening she noticed the bruising and swelling when she undressed.  Rates pain 3 on 1 - 10 scale.  Also states she bruises easy.									Y	10/24/2006	10/24/2006	0	none	UNK	UNK	Enbrol injections q. wkly Leventhriod Tenormen Hyrochlorothiazide Methatrexate Folic Acid Motrin PRN	No	PCN allergy			1						1	Contusion; Injury; Pain; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71639~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265321	10/25/2006	OH	31.0	31		M	10/25/2006	Patient passed out for around 30 seconds.  This was about 20 minutes after the shot was administered.									Y	10/25/2006	10/25/2006	0		UNK	UNK	n/a	n/a	n/a			1						1	Syncope	FLU3~SANOFI PASTEUR~2217AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265322	10/25/2006	UT	16.0	16		F	10/25/2006	Swelling of entire right arm.  Not treated with exception of Benadryl, improved spontaneously.				Y					Y	10/20/2006	10/21/2006	1	None	UNK	UNK		No	Ectodermal Dysplasia			1						1	Swelling	FLU3~SANOFI PASTEUR~U2218AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~04749F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0265323	10/25/2006	MD	23.0	23		M	10/25/2006	ON 24 OCT 06, RECIEVED LIVE INTRANASAL FLU VACCINE. ON 25 OCT @ 0600 PT STATES HAD A NOSE BLEED CONTINIOUS BLOOD FLOW FROM THE RIGHT NOSTRIL. BEGIN TO FEEL DIZZY, LIGHT HEAD, HEART PALPITATIONS, BEGAN TO FEEL FUNNY AND WEAK. PT WAS SEEN FOR TREATMENT. IV THERAPY, PT RECEIVED 24 HR QUARTERS.				Y					Y	10/24/2006	10/25/2006	1	GLUCOSE TEST: DR STATE IT WAS NORMAL EKG: DR STATE IT WAS NORMAL	MIL	MIL	NA					1						1	Asthenia; Dizziness; Epistaxis; Feeling abnormal; Palpitations	FLUN3~MEDIMMUNE VACCINES, INC.~500430P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0265324	10/25/2006	TX	10.0	10		F	10/25/2006	Pt. complained of right arm and  right axilla swelling. Pt.'s mother states she is taking her to PCP today.  Symptoms started morning after				Y					U	10/23/2006	10/24/2006	1		UNK	UNK	Unknown	Unknown				1						1	Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69899~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0265325	10/25/2006	CO	43.0	43		F	10/24/2006	Client found deceased approximately 53 hours after administration of vaccine.  She had no fevers or other apparent systemic effects.  She had congenital developmental delay, epilepsy, spastic quadriplegia, dysphagia, thyroid cancer. This report is submitted for the unexpected death of a patient 2 days later receiving 2006 Influenza vaccination.  Client  was a 43-year-old female with profound mental retardation and severe developmental disability from unknown prenatal factors.  She had been a resident of a residential long term care facility since she was age 2 years.  She was born at full term after an uncomplicated pregnancy except for very little fetal movement.  She had an uncomplicated delivery, breathed spontaneously, weighted 8 pounds, 7 ounces but demonstrated poor tone and flaccidity during the neonatal period with no improvement.  She subsequently demonstrated further profound developmental disabilities, a generalized tonic/clonic seizure disorder, spastic quadriplegia, severe lumbar scoliosis, osteoporosis, osteoarthritis, dysmenorrhea, dysphagia and episodes of aspiration pneumonitis.  She had been diagnosed with a thyroid tumor in 2005, most consistent with thyroid carcinoma but her guardians had elected to not submit her for treatment of this condition.  She had a diffuse, chronic pain syndrome, possibly related to neuromuscular disorders.  She was legally blind and non-verbal.  She was NPO and had a G-tube for all nutrition and medications.  She was severely disabled, dependent on others for all ADL and had no effective means of communication.  She had an Advance Directive and a DNR order.  Her guardians are her parents.  Client had been in a general decline in health for several years and was being treated for her acute and chronic conditions but with an emphasis on comfort measures and measures to maximize her quality of life.  She received influenza vaccinations annually due to being a high risk individual resident of a long term care facility with no recorded adverse reactions.  On 10-17-06 she had a routine medical evaluation and was found to be in her usual state of compromised health, with no change in treatment recommended.  She was given an influenza vaccine on 10-21-06 at her residence by a facility nurse and appeared to be in stable health at that time.  On daily follow up by nursing she did not appear to be in ill health or have any adverse reaction to the vaccine, with no fever, apparent pain or other discomfort, no abnormal vital signs or rash.  She was last observed during a bed check by her residential staff at 3:30 am on 10-24-06, about 53 hours after the vaccination was given and was observed to be sleeping comfortably in prone position and in no distress.  The staff neither heard nor witnessed anything unusual but when they checked her one hour later at 4:30 am she was found to be unresponsive, cyanotic, with no respiratory effort and no pulse.  Since she had a legal DNR in effect no resuscitation effort was made.  She was pronounced dead at 4:50 am on 10-24-2006 by doctor name given.  The Coroner was contacted, the death was determined to be of natural causes and the body was released to Mortuary. 11/13/06 Received Death Certificate which revealed COD as cardiopulmonary arrest; generalized tonic/clonic seizure disorder; with contributing factors of congenital developmental disability.	Y	10/24/2006							N	10/21/2006	10/24/2006	3		UNK	PUB	Milk of Magnesia 20 cc every bedtime; Tegretol 400 mg every am, 400 mg every pm and 600 mg every bedtime; Diflocenac 50 mg twice a day, Zantac 150 mg twice a day, Actonel 35 mg once weekly, Oxycodone/APAP 5/325 at 12 am, 6 am, noon and 2 at	Significant Chronic Conditions and Diagnosis list: Mental Retardation, profound (level) 318.2, (Etiology) Unknown etiology, (Seizures) Generalized Tonic/Clonic 345.1, (Vision) Legally blind; optic atrophy, bilaterally.  Old retinal detachments, Cataracts, OU, per doctor name reported 7/26/1993; Cataracts both eyes, per doctor name reported 1-6-00; Exophthalmos right eye, long standing; extropia, left eye, 2-27-02.  Episcleritis, right eye 3-03.  (Hearing) Hearing is normal in both ears, 8-02.  (Chronic Pain) Chronic pain syndrome 733.90, 5-31-01: possibly secondary to Ostoarthritis or symptomatic scoliosis.  (Dental) Bruxism severe 9-25-98, (GI) Constipation 564.00, (G-Tube) Status/Post Nissen Fundoplication with Gastrostomy tube 10-04-88.  (GYN) History of Dysmenorrhea and irregular periods 625.3; Fibrocystic breasts 610.1, biopsy 4 mm mass of left breast, benign, 10-19-01.  (Ortho) Severe lumbar scoliosis 737.30, Spastic quadriplegia 343.2; Fracture right proximal Femur 11-27-00 with open reduction internal fixation (ORIF); refractured 3-18-01 and repeat ORIF.  (ORTHO) Osteoporosis 733.0, 3-19-02, (Other) Local reaction to IV Morphine Sulfate 11-27-00; Athetoid Movement Disorder 333.90, Right sided nodular Thyroid neoplasm 193, (Respiratory) Pneumonia, 3/01, (Surgery) Abscess, left axilla, incised and drained, doctor name reported, 9-18-99; resolved, 10-4-99	Significant Chronic Conditions and Diagnosis list: Mental Retardation, profound (level) 318.2, (Etiology) Unknown etiology, (Seizures) Generalized Tonic/Clonic 345.1, (Vision) Legally blind; optic atrophy, bilaterally.  Old retinal detachments, Cataracts, OU, per doctor name reported 7/26/1993; Cataracts both eyes, per doctor name reported 1-6-00; Exophthalmos right eye, long standing; extropia, left eye, 2-27-02.  Episcleritis, right eye 3-03.  (Hearing) Hearing is normal in both ears, 8-02.  (Chronic Pain) Chronic pain syndrome 733.90, 5-31-01: possibly secondary to Ostoarthritis or symptomatic scoliosis.  (Dental) Bruxism severe 9-25-98, (GI) Constipation 564.00, (G-Tube) Status/Post Nissen Fundoplication with Gastrostomy tube 10-04-88.  (GYN) History of Dysmenorrhea and irregular periods 625.3; Fibrocystic breasts 610.1, biopsy 4 mm mass of left breast, benign, 10-19-01.  (Ortho) Severe lumbar scoliosis 737.30, Spastic quadriplegia 343.2; Fracture right proximal Femur 11-27-00 with open reduction internal fixation (ORIF); refractured 3-18-01 and repeat ORIF.  (ORTHO) Osteoporosis 733.0, 3-19-02, (Other) Local reaction to IV Morphine Sulfate 11-27-00; Athetoid Movement Disorder 333.90, Right sided nodular Thyroid neoplasm 193, (Respiratory) Pneumonia, 3/01, (Surgery) Abscess, left axilla, incised and drained, doctor name reported, 9-18-99; resolved, 10-4-99			1						1		FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70385~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0265329	10/25/2006	CA	4.0	4		M	10/23/2006	Swollen, tender, red and fine large area at site of vaccine. Prescribed compresses and Motrin PRN.				Y						10/18/2006	10/18/2006	0	NONE	PVT	PVT						1						1	Injection site erythema; Injection site pain; Injection site swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B032AA~UNK~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2237AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1051~UNK~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0099N~UNK~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0265331	10/25/2006	MA	34.0	34		F	10/24/2006	Approximately 5.5 hours after flu shot administered, patient reported that she developed bilateral conjunctivitis - lasted < 24 hours and required no medical treatment. S/S included bilateral bright red eyes, bilateral burning in eyes. No discharge or pus, cough, headache, muscle aches, fever (did not check her temperature).									Y	10/20/2006	10/20/2006	0	NONE	OTH	PVT	NONE	NONE	Allergies to trees, grass, mold; no medical conditions.			1						1	Conjunctivitis; Eye irritation; Ocular hyperaemia	FLU3~SANOFI PASTEUR~U2213AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265332	10/25/2006	PA	75.0	75		F	10/18/2006	Right upper arm swelling, itching, pain, edema skin from deltoid to elbow within 4 hours.  By next am after Prednisone edema upper arm less.  Bruised appearance to upper forearm.  Patient on Coumadin.  Did ice arm and apply pressure.  Not clear hematoma as more serious swelling.				Y						10/17/2006	10/17/2006	0		PVT	PVT	Coumadin	NONE	chronic Coumadin			1						1	Contusion; Oedema; Pain; Pruritus; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~694323~2~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0320F~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0265333	10/25/2006	DE	70.0	70		F	10/25/2006	Patient reports evening after flu vaccine had fever of 102 and was talking out of her head. Symptoms lasted for 2 days.									Y	10/16/2006	10/17/2006	1		PVT	UNK		NONE	HTN; IDDM; COPD			1						1	Abnormal behaviour; Pyrexia	FLU3~SANOFI PASTEUR~U2177AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265334	10/25/2006	FL	1.54	1	.5	M		Given DTaP, Hep A, and flu vaccine 10/23/2006. On 10/24/06, developed hives on arms and hands swollen. Not sure if from vaccine.										10/23/2006	10/24/2006	1		PVT	UNK						1						1	Oedema peripheral; Urticaria	DTAP~SANOFI PASTEUR~C2477AA~4~IM~UN~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2174AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB06AA~1~IM~UN~HEP A (HAVRIX)~1	USA		Influenza
0265336	10/25/2006	AZ	69.0	69		F	10/19/2006	The vaccine was administered at approx 9:10am, her symptoms started 2 hours later. Her left arm was hard, hot and sore. She had chills and a fever of 100. By evening it was really hot and red and she went to bed early. Arm was hard up to the arm pit on outside and red inside, Entire arm had a red streak. Hot until 10/18/06									Y	10/16/2006	10/16/2006	0		PUB	PVT			Allergic to Penicillin			1						1	Chills; Erythema; Injection site erythema; Injection site induration; Injection site pain; Injection site warmth; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69426~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265337	10/25/2006	AZ	47.0	47		F	10/24/2006	She immediately got an uncomfortable feeling of medicine going through her veins. From that time until 10/21/06 she had red blotches at the injection site. Her armpit felt swollen and tender to the touch. Arm felt feverish. Her shoulder and left breast felt swollen to touch. Hives red welts around the arm pit but not at the injection site.									Y	10/18/2006	10/18/2006	0		PUB	PVT		NONE	NONE			1						1	Discomfort; Erythema; Injection site erythema; Injection site warmth; Oedema; Rash macular; Tenderness; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71210~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1048P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265338	10/25/2006	MI	1.03	1	.0	M	10/17/2006	None Stated										10/13/2006				PVT	PUB						1						1		FLU3~SANOFI PASTEUR~V2175HA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB099CB~1~IM~UN~HEP A (HAVRIX)~1|HIBV~MERCK & CO. INC.~0212R~4~IM~UN~HIB (PEDVAXHIB)~1|HPV4~MERCK & CO. INC.~0688F~1~IM~UN~HPV (GARDASIL)~1|PNC~PFIZER\WYETH~B22930D~4~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0265345	10/25/2006	MD	1.28	1	.3	F	10/25/2006	Fever to 104, generalized seizure taken by paramedic to ER.				Y					Y	10/19/2006	10/19/2006	0	CBC, blood culture	PVT	UNK		NONE	NONE			1						1	Convulsion; Pyrexia	DTAP~SMITHKLINE BEECHAM~AC14B040BA~4~~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2275AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0279F~3~~LA~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08646C~4~~RA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0265353	10/25/2006	MA	34.0	34		F	10/25/2006	Symptoms = Arm swelling Signs = Red Time Course = 10 minutes post injection Treatment = Sent patient to her OBGYN.  They said arm swelling went down.  They monitored patient.									Y	10/23/2006	10/23/2006	0		UNK	UNK			Pregnant - 6 months	Arm swelling~Influenza (Seasonal) (Fluzone)~1~0.00~In Patient		1						1	Swelling	FLU3~SANOFI PASTEUR~U2165EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265354	10/25/2006	MA	48.0	48		F	10/25/2006	Symptoms = Swelling in deltoid Signs = Swelling Time Course = within minutes Treatment = Sent to ED, arm was iced. pt discharged.				Y					Y	10/20/2006	10/20/2006	0		UNK	UNK				Deltoid Swelling~Influenza (Seasonal) (Fluvirin)~4~0.00~In Patient		1						1	Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~AFLUA208BA~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0265355	10/25/2006	NC	46.0	46		F	10/25/2006	The day after flu shot was given, I had dry heaves, severe migraine that lasted all day and into the evening.  That afternoon went to ER.  Was given Toradol injection for headache which took an hour or so before the headache started to get better.				Y					Y	10/23/2006	10/24/2006	1	CT scan head 10/24/06 - Good	MIL	OTH	Metoprolol, lisinopril, Protonix, Wellbutrin, triamterene/HCTZ	None	High BP, GERD, PMS			1						1	Migraine; Retching	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA218BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0265356	10/25/2006	MD	5.0	5		M	10/25/2006	1. Abdominal pain and vomiting about 52 hours post vaccine (lasted 45 mins, then cleared) 2. Stuffy, runny nose coupled with cough from +/- 52 hours post vaccine until present (treating with OTC medications) 3. Low grade fever 52 hours post vaccine (cleared overnight with 1 dose of Motrin)									N	10/20/2006	10/22/2006	2	None	UNK	UNK	Prevacid, Zyrtec	None	environmental allergies, brachial plexus injury at birth (2 subsequent surgeries)			1						1	Abdominal pain; Nasal congestion; Pyrexia; Rhinorrhoea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0265358	10/25/2006	NJ	65.0	65		F	10/25/2006	At 7pm on 10/23/06 pt c/o inside of L ear and eardrum became itchy.  As evening advanced, itching progressed to L eye.  At 6am pt c/o bilateral eyes and ears reddened and itching, neck and back of scalp burning, hot, reddened and itching.  Pt came to work at 8am and symptoms progressed where itching became intense and lips, chest, inside of mouth and throat became involved.  Pt called Public Health Nursing and was advised to seek medical assistance immediately.  Pt. seen at Dr.Is In T /?, P 85, B/P 140/76 and given steroid injection and Benadryl. Pt. returned to work and called clinic.  Advised to read discharge instructions and if sx worsened to go to call 911 and get to ED.				Y					N	10/23/2006	10/23/2006	0		UNK	UNK	Singulair,Rhinocort, Fosamax,Zetia,Vit D, Calcium, B Complex, Multi Vit, Glucosamine, flax seed oil	no	asthma, seasonal allergies, food allergies - soy, apples, nuts and elevated cholesterol.  A number of yrs ago had a drug reaction where/extremities (bilateral arms and legs) became red and hot. Treated with medication and told never to take that med again.  Does not know what med she took.			1						1	Erythema; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69424~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0265359	10/25/2006	GA	64.0	64		F	10/25/2006	Difficulty breathing, hoarseness, wheezing									U	10/24/2006	10/24/2006	0		UNK	UNK	none	none	hay fever			1						1	Dysphonia; Dyspnoea; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA220AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0265360	10/25/2006	KY	60.0	60		F	10/25/2006	Patient developed redness and swelling the evening after the vaccination.  On her own, she put a heating pad over the area.  Called to discuss with Pharmacist on Wednesday 10-25-06, she referred her to another pharmacist.  He advised the patient to take some diphenhydramine and to use cold compress and seek medical treatment if it worsened.  We didn't hear anything else until ARNP from medical association called around 3:00pm 10-25-06 and told us the patient had a documented case of cellulitis.  I phoned the pharmacy's clinical coordinator and she referred me to this form and she was to call our pharmacy district manager.				Y					U	10/23/2006	10/23/2006	0	Cellulits per ARNP	UNK	UNK	Premarin 0.625mg 1 QD Carisoprodol 350mg 1 q6-8h Hydrocodone/APAP 10/325mg 1 q8h Axert 12.5mg 1 as needed Celebrex 200mg 1 qd Alprazolam 0.5mg 1/2 bid Lexapro 20mg 1 bid Nasonex 2 sprays each nostril qd	unknown	unknown			1						1	Cellulitis; Swelling	FLU3~SANOFI PASTEUR~U2274AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0619F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0265361	10/25/2006	OR	69.0	69		M	10/25/2006	Hives from head to toe.  Puritis.  No breathing difficulties.  Reaction occurred with in 15-30 minutes of receiving vaccination.  Patient has received flu vaccination many times in the past without reaction.  Patient seen in the ER and treated with Solumedrol 125mg IM, Benadryl 50mg po and released.				Y					U	10/25/2006	10/25/2006	0	none.  Vaccine type - Flulaval -below will not allow me to enter this data	UNK	UNK	Metoprolol, aldactone, lisinopril, asa, piroxicam, lipitor, doxazosin	none	chf, chronic renal insufficiency, bph, hyperlipidemia			1						1	Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601011~7+~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0265362	10/25/2006	TX	37.0	37		F	10/25/2006	immediately after vaccination noticed bruising and knot at site of injection. Day after vaccine had cough, flu-like symptoms and sinus infection (dx by MD. On 10/22/06 noted numbness sensation on hands, feet and part of mouth.  1/16/07 Received medical records from neurologist which reveal initial eval done 10/30/06 for progressive weakness & tingling of extremities.  Patient had viral illness of fever, malaise, arthralgias & nausea s/p flu shot 2 weeks prior.  Then developed tingling  of bilateral toes which progressed up & into her hands with weakness of all extremities along with significant imbalance.  Patient reported going to ER on 10/26. Exam revealed absent reflexes, finger to nose & heel to shin were ataxic, gait was wide based & unstable.  Patient seen on 10/31 with some improvement & dx unchanged.  Next seen on 11/13 with significant improvement.  Continued to have left facial palsy & was treated with ointment & taping at night.   FINAL DX: Miller-Fisher variant of GBS based on clinical s/s of prominent ataxia, double vision, areflexia & retained power.  Complete seventh nerve palsy.  It was felt that all of her symptoms were secondary to the flu shot & that patient would continue to improve over time. 2/1/07 Received medical records from hospital ER & Employee health which reveal patient seen in ER on 10/26/06 with tingling of fingers, feet, mouth & tongue with nausea.  Ambulation noted to be unsteady & hand grips were equal but weak. FINAL DX: Anxiety r/o hyperventilation.				Y					U	10/18/2006	10/18/2006	0	none LABS: EMG/NCS was essentially WNL with left tibial & peroneal F wave had no response.  MRI of brain revealed white matter disease, thought to be demyelinating,of unknown etiology & was to be repeated in 6 mo.  CT of chest done 10/26 was WNL.  WBC done 10/26 9.7, diff was WNL.	UNK	UNK	Multi-vitamin	none	Cervical Cancer - 5 years in remission PMH: cervical cancer in remission, recent weight loss of 10# with decreased appetite.  Occasional double vision.			1						1	Contusion; Cough; Hypoaesthesia; Influenza like illness; Injection site mass; Injection site reaction; Sinusitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70277~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0265364	10/25/2006	AZ	49.0	49		F	10/25/2006	cellulitis diagnosed on 10/25/06 in right arm irregular shaped lesion about 24cm x 14cm along widest points low grade fever numbness & tingling in arm; muscle pain, skin sensitivity Keflex & Bactrim for 10 days Tetnus shot  scheduled for recheck 10/26				Y					U	10/23/2006	10/23/2006	0	blood work CBC	UNK	UNK	Zoloft 50 mg daily	none	none			1						1	Cellulitis; Hypoaesthesia; Myalgia; Paraesthesia; Pyrexia; Skin disorder; Skin ulcer	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0265374	10/26/2006	KS	65.0	65		M	10/23/2006	Information has been received from a physician concerning a 65 year old male pt with coronary artery disease, congestive heart failure, type II diabetes, and kidney stones and a history of gastric banding who on 10/17/06 was vaccinated on left shoulder with his first dose of Pneumococcal 23v polysaccharide vaccine (lot 651322/1044P). The pt also received influenza virus vaccine on the right shoulder. Concomitant therapy included Altace, Elavil, Lasix, potassium, Coreg and Keflex. Within 3 hours the pt had localized pain left arm and shivering. An hour later he had sluggish speech, was confused, and was taken to the ER with a systolic blood pressure of 129 and sat oxygen of 100%. He was confused, and slurred speech, and severe shivering. Warm blanket and oxygen administered. The pt had severe left shoulder pain, especially with movement, with a heavy sensation in arm. The physician indicated that blood tests including cardiac enzymes were performed, and that the events did not appear to be cardiac related. The pt was not able to raise his arm but was able to move his fingers, there was severe pain with passive movement of arm. Additional vital signs included systolic blood pressure 109, pulse 55, temp 97.7. The physician stated that he may need to transfer the pt to a larger facility for treatment, evaluation, and possible admission. The reporter also indicated that previous doses of influenza virus vaccine have not resulted in adverse symptoms. the physician considered the events to be immediately life threatening, and other important medical events (OMIC). A product quality complaint was not involved. Additional information has been requested.			Y	Y					N	10/17/2006	10/17/2006	0		OTH	OTH	ELAVIL, COREG, KEFLEX, LASIX (FUROSEMIDE), potassium (unspecified), ALTACE		Gastric banding, Coronary artery disease, cardiac failure congestive, type II diabetes mellitus, kidney stone.		WAES0610USA10776	1						1	Chills; Confusional state; Hypokinesia; Hypoxia; Injection site pain; Sensation of pressure; Shoulder pain; Speech disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1044P~1~~UN~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening	Influenza
0265386	10/26/2006	NE	25.0	23		F	10/23/2006	Received Fluvirin 0.5cc IM left deltoid. Within 15 minutes of receiving shot, developed severe pain and numbness down arm. Ached all over, anxiety. Denied SOB or chest tightness.									Y	10/19/2006	10/19/2006	0	NONE	OTH	PVT	NONE	NONE	Panic attacks			1						1	Anxiety; Hypoaesthesia; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69424~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265388	10/26/2006	MN	43.0	43		F	10/21/2006	Swollen tongue, sore on tongue. Flu symptoms - nausea, diarrhea, body aches, temp 98.6. Flu symptoms lasted for 1 week. Swollen tongue and sores lasted for 2 days.									Y	10/11/2006	10/11/2006	0		PUB	UNK	Nexium	NONE	NONE			1						1	Diarrhoea; Influenza like illness; Nausea; Pain; Tongue oedema; Tongue ulceration	FLU3~SANOFI PASTEUR~U2169NA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265389	10/26/2006	FL	61.0	61		F	10/20/2006	Mild case of painful to the touch feeling on buttocks and upper thigh of one leg. Lasted about 5 days, then went away. Caused me to wonder if I might come down with hives since I knew that was a symptom.									Y	10/06/2006	10/09/2006	3	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0265390	10/26/2006	VA	19.0	19		M	10/19/2006	Urticaria both elbows.									Y	10/19/2006	10/19/2006	0	NONE	MIL	MIL		NONE	NONE			1						1	Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA219BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1|TYP~SANOFI PASTEUR~Z0276~UNK~IM~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0265391	10/26/2006	WI	67.0	67		F		Site of pneumonia shot swollen, hot, red (4x6), fever 102.4, aches and chills, slight nausea. Next 4 days, arm hot, fever steady at 99. Used Naprosyn 230mg (2) BID, hot packs to arm.									Y	10/09/2006	10/10/2006	1	NONE	OTH	OTH	Avandia; Foradil; Spiriva; Lipitor; Cozaax; Clonidine	NONE	Diabetes; Asthma; Emphysema; Multiple drug allergies.			1						1	Chills; Injection site erythema; Injection site swelling; Injection site warmth; Nausea; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~3~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265392	10/26/2006	CO	47.0	47		F	10/18/2006	Myalgias, numbness, nightmare, anxiety, small ring redness around injection site.				Y					Y	10/17/2006	10/18/2006	1		PVT	PVT	Lipitor; Benadryl; Prozac	NONE	NONE			1						1	Anxiety; Hypoaesthesia; Injection site erythema; Myalgia; Nightmare	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71213~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0265393	10/26/2006	NY	5.0	5		F	10/26/2006	Within one hour after treatment, head jerking for 5 minutes.									Y	10/25/2006	10/25/2006	0	NONE	PVT	UNK	NONE	Mild pharyngitis; strep negative	NONE			1						1	Dyskinesia	DTAP~SANOFI PASTEUR~C2630AA~5~~~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2169MA~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0240~4~~~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0265394	10/26/2006	NC	19.0	19		M	09/12/2006	The clinical history is that of a 19 year old man who received a smallpox vaccine 8 days prior to presenting with numerous small pustular lesions over his entire body and scalp. The histologic findings of Intracorneal vesicles, basilar layer reduplication with prominent nucleoil, scattered keratinocyte cytoplasmic changes and the presence of moderate mixed (lymphocytic/neutrophilic0 perivascular.				Y						08/31/2006	09/07/2006	7	Skin Biopsy (tissue sample) for pathology.	MIL	MIL	Hydrocodone; Naproxen; Clindamycin	NONE	NONE			1						1	Blister; Rash pustular; Skin ulcer	FLUN3~MEDIMMUNE VACCINES, INC.~500429P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB068BC~4~IM~~HEP A + HEP B (TWINRIX)~1|TYP~SANOFI PASTEUR~Z0425~2~IM~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0265408	10/26/2006	VA	76.0	76		M	10/26/2006	Pt recieved a ppv-23 pneumovax on 10/18/06. On 10/20/06 pt returned to office with low grade fever, pain and swelling distally from injection site (SQ) in left upper extremity to the mid forearm.  Area warm to touch, erythematous and edematous.  Diagnosed as cellulitis, given Ciprofloxacin x 10 days.  To be seen for recheck in 2 weeks. Pt was co-administered Fluviron Flu Vaccine the same visit (10/18/06) in the Right upper extremity without adverse effect. The PPV-23 was  lot #0485F exp.5/5/07.									Y	10/18/2006	10/19/2006	1	T-99.2 po, p-68,rr-18, bp 138/64.  Uric acid collected to r/o gout level 4.8 mg/dl (WNL)	UNK	UNK	Flomax 0.4 mgg 2 tabs po qd Zocor 80 mg po BID Rantidine 150 mg po BID	None reported	Dyslipidemia, Nocturia, BPH, DM type II, Ventral hernia, colon polyps			1						1	Cellulitis; Injection site erythema; Injection site oedema; Injection site pain; Injection site swelling; Injection site warmth; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70385~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0485F~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265409	10/26/2006	NC	70.0	70		F	10/26/2006	Patient received Pneumovax right deltoid intramuscular on 10/24/2006.  Patient had complaints of pain at injection site that night and a fever the following morning of 99.5 F.  Patient also developed red streaks on bicep of right arm with swelling and tenderness.  Patient has been taking Tylenol for pain.				Y					U	10/24/2006	10/24/2006	0		UNK	UNK	Unknown	No	No			1						1	Erythema; Injection site pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70741~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1044P~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U1880CA~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0265410	10/26/2006	MN	37.0	37		F	10/26/2006	Medical Asst. administered, in error, an injectable flu vaccine intra-nasally. The precipating events are as follows:  1)On 10/23 at 0615a, vaccines were incorrectly dispensed by Pharmacist ; specifically, the correct 500 doses of injectable vaccine was correct but the 60 doses of  Fluarix was incorrect (correct vaccine is FluMist).  2)MA administered the vaccine intranasally althougth she questioned is looked different there was a plastic valve that somewhat mirrored the one on the FluMist.   3)Employee/patient described the feeling of fluid down her throat not that of a mist which caused MA and her concern enough to discuss with writer who was adminstering other vaccines and TB Tests at the time.   4)MA states she examined the insert after and furthered questioned the vaccine administration but did not immediately recognize is was IM administration only. Potential Injury: Pharmacy contacted the manufacturer rep and confirmed there are no adverse reactions due to the injectable form of vaccine being administered/absorped into the nasal mucosa; no mild irration was noted by patient when contacted several hours later; no benefit of immunity is obtained by this method.  Readministration of injectable or intranasally was recommended.  Additional Comments:1) Pharmacy notified of error in dispensing of vaccine in order to determine process defects or procedural concerns. 2) Medical Assistants not considered qualified to make medical/clinical decisions that require judgement. MA did question the unusual container after the employee/patient commented after the the medical was administration, she did review the insert (per patient) and mentioned to writer that it looked different.  3) The RNs responsible for ensuring the vaccine is correct; RNs take some responsibility for not reading carefully the product packaging and/or insert. RN at the time of pick up from Pharmacy and writer after incorrect administration.  4) A 2nd occurrence happened several minutes later 5) VAERS report will be completed									Y	10/23/2006				UNK	UNK		none	none known			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFUA206BA~1~IN~NS~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0265411	10/26/2006	WA	53.0	53		F	10/26/2006	Urticaria on face, arms and trunk.									U	10/24/2006	10/24/2006	0	None.	UNK	UNK		No.	Allergies to demerol, hydrocodone, cefzil and septra.			1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70619~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265412	10/26/2006	MN	48.0	48		F	10/26/2006	Medical Assistant administered, in error, an injectable flu vaccine intra-nasally. The precipating events are as follows:  1) On 10/23 at 0615a, vaccines were incorrectly dispensed by Pharmacist; specifically, the correct 500 doses of injectable vaccine was correct but the 60 doses of Fluarix was incorrect (correct vaccine is FluMist. 2)MA administered the vaccine intranasally after she questioned it looked different but there was a plastic valve that somewhat mirrored the one on the FluMist.   3) Patient described the feeling of fluid down her throat.   4)MA had just prevsious given one dose incorrectly to another patient and then states she examined the insert after and further questioned the vaccine administration but did not immediately recognize it was IM administration.   5) MA did showed injectable syringe to writer (RN) who was giving other vaccines and TB tests. It was after that the MA reviewed the packaging again and found this to be the injectable flu vaccine incorrectly dispensed by pharmacy and undetected by HS.  Potential Injury: Pharmacy contacted the manufacturer's rep and confirmed there are no adverse reactions due to the injectable form of vaccine being administered/absorped into the nasal mucosa; no mild irration was noted by patient when contacted several hours later; no benefit of immunity is obtained by this method. Readministration of injectable or intranasally was recommended.   Additional Comments: 1) Pharmacy notified of error in dispensing of vaccine in order to determine process defects or procedural concerns. 2) Medical Assistants not considered qualified to make medical/clinical decisions that require judgement. MA did question the unusually container after the employee/patient commented after the the medical was administration, she did review the insert (per patient) and mentioned to writer that it looked different.  3) The RNs responsible for ensuring the vaccine is correct; both RN and writer (RN) take some responsibility for not reading carefully the product packaging and/or insert. RN at the time of pick up from Pharmacy and writer after incorrect administration.  4) Further clinical judgement by MA and RN before or after 1st incident would have prevented this one. 5) VAERS report will be completed									Y	10/23/2006				UNK	UNK		none	none			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA206BA~1~IN~NS~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0265413	10/26/2006	FL	58.0	58		F	10/26/2006	Had the PPV shot along wityh the influenza shot and with in 6 hours started running a high fever of 101 It lasted for at least 48 hours....the arm where the ppv was injected became extremly painful I could not move the arm at all and it was swollen and inflamed and a BIG red mark around the injection sight...It iwas so painful I couldnt move oreven touch my arm,...the aches and fever were unbarable as of today October 26th the arm is still swollen hot and tender to the touch and a big red mark where the shot was adminisered				Y					U	10/23/2006	10/23/2006	0		UNK	UNK	prozac	none	none			1						1	Hypokinesia; Injection site erythema; Injection site inflammation; Injection site pain; Injection site swelling; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0265414	10/26/2006	VA	21.0	21		M	10/26/2006	Throbbing Headache that started 7 hours after Flu-mist and and lasted 4 days.  Seen in office visit.				Y					Y	10/16/2006	10/16/2006	0	None	MIL	MIL	None		None			1						1	Headache	FLUN3~MEDIMMUNE VACCINES, INC.~500433P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0265415	10/26/2006	IL	1.3	1	.3	M	10/26/2006	RECIEVED DTap,HIB AND FLU ON OCT 19TH. MOM REPORTED YESTERDAY THAT SEE NOTICED RED RAISED BUMPS ON THE TRUCK OF HIS BODY AND BOTH ARMS AND LEGS. MOM REPORTS THAT CHILD HAD NO FEVER. HAS BEEN ON 9DAY THERAPY TREATMENT OF AMOXILLICIN, WHICH MOM REPORT THAT SHE IS ALLERGIC TO AMOXICILLIN.				Y					U	10/19/2006	10/25/2006	6		UNK	UNK	AMOXICILLIN	MOM REPORT NONE AT TIME OF VACCINATION	NONE			1						1	Rash erythematous	DTAP~SANOFI PASTEUR~C2406AA~1~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2174DA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE872AA~4~IM~RL~HIB (ACTHIB)~1	USA	Emergency room visit	Influenza
0265417	10/26/2006	TX	40.0	40		F	10/26/2006	90 min after FluMist pt experienced flushing which progressed to cough and chest tightness.  progressed to throat tightness and itching, difficulty swallowing.  Eyes became red. Cough worsened.  Returned to clinic.  No wheezing.  Vitals stable.  No hives.  treated with Epi and Zyrtec.  Sx resolved.				Y					Y	10/26/2006	10/26/2006	0	Tryptase pending	MIL	MIL	None	None	None			1						1	Chest discomfort; Cough; Dysphagia; Flushing; Pruritus; Throat tightness	FLUN3~MEDIMMUNE VACCINES, INC.~500431P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0265418	10/26/2006	VA	0.5	0	.5	F	10/26/2006	Blotches of redness over trunk and extremities. Otherwise stable.				Y					U	10/25/2006	10/25/2006	0	Pulse ox 97%	UNK	UNK		Runny nose, stuffy nose, cough				1						1	Erythema	DTAP~SANOFI PASTEUR~c2627aa~UNK~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~ut2175ba~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1099r~UNK~IM~LL~HEP B (RECOMBIVAX HB)~1|HIBV~CONNAUGHT LABORATORIES~0277f~UNK~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~b08649e~UNK~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0265420	10/26/2006	TX	25.0	25		F	10/26/2006	Aprroximately 0900 on 10/25/2006 received vaccination to right deltoid. Blisters noted this morning when itching began at site.									Y	10/25/2006	10/26/2006	1		UNK	UNK			Environmental/seasonal allergies			1						1	Injection site reaction; Injection site vesicles; Pruritus	FLUX~UNKNOWN MANUFACTURER~71640~3~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0265424	10/26/2006	VA	0.75	0	.7	M	10/26/2006	Patient presented fever and fussiness (7 hours after vaccine administered). Vomiting 15 times > (24 hours after loss of consciousness for seconds and stiffness. Repeated similar episodes 4 hours after. 12/22/06 Received medical records from hospital which reveal patient admitted 10/24/06-10/27/06 with fever & vomiting since receiving flu vax.  On day after vax had brief tonic-clonic episode with eyes rolling back, cyanosis & limpness afterward.  Fever 101 & had 2nd seizure.  Afebrile in hospital & no further seizures. Final DX: Febrile seizure s/p immunization w/flu vax; 2 brief febrile seizures.					Y	2			Y	10/23/2006	10/23/2006	0	LABS: WBC initially 26,100, neutros 54, bands 11, lymphs 22, monos 13.  Initial blood cultures 10/25 grew gram + coccus, coag neg staph aureus which was thought to be contaminant.	OTH	PUB	ALBUTEROL MDI 2 puffs as needed	reactive airways disease	allergy to amoxicillin possible allergy to ceftriaxon. PMH: URI at 3 months of age, pneumonia & RAD 10/06 with fever of 106 associated w/jerky movements but no cyanosis.  Treated w/IV & oral antibiotics, inhaler & prednisone. Birth Hx: c section for transverse lie, 7#.			1						1	Cyanosis; Eye movement disorder; Grand mal convulsion; Irritability; Laboratory test abnormal; Leukocytosis; Loss of consciousness; Musculoskeletal stiffness; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2175HA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0265425	10/26/2006	PA	1.07	1	.1	M	10/26/2006	6 days after receiving influenza vaccine and ProQuad pt developed fever 101.7 and ataxia with frequent falling.									U	10/19/2006	10/24/2006	5		PVT	PVT						1						1	Coordination abnormal; Fall; Pyrexia	FLU3~SANOFI PASTEUR~U2174EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~0978F~1~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0265426	10/26/2006	MO	50.0			M	10/26/2006	Fever to 105, confusion, WBC increase 26,000 within 24 hrs of receiving a flu vaccine and Pneumococcal vaccine. Required ER visit IV hydration.				Y					Y				WBC increase 26,000	PVT	UNK		NONE	NONE			1						1	Confusional state; Pyrexia; White blood cell count increased	FLU3~SANOFI PASTEUR~U215AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0089F~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0265427	10/26/2006	CA	64.0			F	10/26/2006	Redness, swelling in right upper arm with tingling in fingers after pneumonia shot. Presented 10/26/06 to community clinic with improvement of signs and symptoms. States she had a bee sting (yellow jacket) RUA 1 week before her shot in the right axilla area.									U	10/24/2006	10/24/2006	0		PUB	OTH						1						1	Injection site erythema; Injection site oedema; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA213AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0485F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265428	10/26/2006	WA	47.0	46		M	10/26/2006	10/24/06 Pneumonia vaccine and influenza vaccine given left deltoid one inch apart per pt requested. 10/25/2006 2pm pt seen due to swelling, redness, burning left deltoid. Pt had 101 temp, malaise, myalgia, headache and sinus congestion. Pt stated he felt awful, I gm of Rocephin given right deltoid, pt request. Pt given RX for Keflex 500 mg P WID x 10 day. 2 325mg aspirin given for fever. 10/26/06 call from wife pt vomiting and temp came back last night at 102. Wife instructed to take pt to ER for evaluation and treatment.				Y						10/24/2006	10/25/2006	1		PVT	PVT	Concerta, Zoloft, Xanax, Androgel, Loprox.		ADD, male hypogonadism, Migraine, anxiety.			1						1	Headache; Injection site erythema; Injection site oedema; Malaise; Myalgia; Pyrexia; Sinus congestion; Skin burning sensation; Vomiting	FLU3~SANOFI PASTEUR~U2242AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0485F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0265429	10/26/2006	AK	63.0	63		F	10/26/2006	Left arm Red, swollen arm shoulder to elbow, painful, ROM, started 10/24/06 afternoon. C/o feeling achy all over, chills that evening. Took TYLENOL improvement today 10/26/06.										10/24/2006	10/24/2006	0	NONE	PUB	PUB		NONE				1						1	Chills; Injection site erythema; Injection site oedema; Injection site pain; Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~U2237AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1008P~2~IM~LA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~LC2340AA~7+~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0265430	10/26/2006	AK	60.0	60		F	10/26/2006	Red welts on upper part of legs, itch, time approx 10am, given a shot of Benadryl.									Y	10/25/2006	10/25/2006	0	NONE	OTH	PUB		NONE	Ampicillin, Sulfa, shrimp; ?		AK200640	1						1	Erythema; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2238AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265431	10/26/2006	TN		53		F	10/26/2006	Extreme pain on right arm felt like it was dislocated. Had nausea from pain.  Tylenol did not help slept through Saturday, Sunday was able to move arm only from wrist to elbow, Monday had more movement on Wednesday was back to normal.									Y	10/20/2006	10/20/2006	0		OTH	PUB	RISPERIDAL	NONE	NONE			1						1	Nausea; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0265432	10/26/2006	TX	3.0	3		F	10/25/2006	4-5 hours after immunization patient developed hives----> resolved after 1 dose BENADRYL; patient also complain of leg pain at injection site.  24 hours after immunization noted local reaction (erythema, warmth, induration) around injection site.  When measured at clinic 82.4 Fahrenheit immunization local reaction 10 x 7 cm.									Y	10/24/2006	10/24/2006	0	NONE	PVT	PVT		NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site warmth; Pain; Urticaria	FLU3~SANOFI PASTEUR~U2166KA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~BOF131R~4~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0265433	10/26/2006	MS		55		F	10/26/2006	Tightness on upper leg muscles was not able to use these muscles to stand up.  Tightness gradually decreased over 4 days.  Only had residual soreness for 3 days specially on muscles above the knee towards the hip joint.									Y	10/05/2006	10/05/2006	0		OTH	PVT	ALLEGRA, LIPITOR, Rowaza, Colazae, EFFEXOR, REMERON, Eusia, Potassium CL, Multivitamin, Ca with lorgard, HCTZ	NONE	seasonal allergies, high cholesterol and high blood pressure, allergic to penicillin, sleep apnea, Krones disease, mitral valve prolapse.			1						1	Myalgia	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0265434	10/26/2006	VA	26.0	26		M	10/25/2006	Injection given in left deltoid, left fore finger and left thumb presented with numbness within 10 minutes of injection.									U	10/25/2006	10/25/2006	0		OTH	UNK		yes	NONE			1						1	Hypoaesthesia	FLU3~SANOFI PASTEUR~U2195AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265445	10/26/2006	NE	1.3	1	.3	M	10/26/2006	Extreme fussiness and muscle spasm									Y	10/13/2006	10/13/2006	0		UNK	UNK		Loose stools x 2, temperature of 102 previous week.  Presumed teething.	Reflux; resolved.			1						1	Irritability; Muscle spasms	DTAP~SANOFI PASTEUR~C2129AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2174HA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0310F~1~IM~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08682A~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0265449	10/26/2006	KS	63.0	63		F	10/26/2006	Patient described fever of 100.6, redness, swelling, itching at site of injection.									Y	10/20/2006	10/20/2006	0	none	MIL	MIL	unknown	none	Hx of allergy to eggs, but several years ago went to allergist to be tested and such small rxn told her to get flu injection and never has any issues for several years except on this date.			1						1	Injection site erythema; Injection site reaction; Injection site swelling; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~U2199AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265450	10/26/2006	WA	68.0	68		F	10/26/2006	I first gave influenza vaccine in left deltoid, then immediately administered pneumonia vaccine in right deltoid. Patient said she immediately had metallic taste when given pneumonia shot.  She then began to flush bright red on face and extremities and said she felt dizzy.  I gave her (2) diphenhydramine 25mg capsules.  Patient rested about ten minutes (her pulse was taken periodically) and then said she felt fine (skin color looked normal at that time, also). She called later in evening to report that she felt fine and we followed up with her again the next morning.									Y	10/23/2006	10/23/2006	0		UNK	UNK	N/A					1						1	Dizziness; Dysgeusia; Erythema; Flushing	FLU3~SANOFI PASTEUR~U2218AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0619F~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265453	10/26/2006	UT	2.0	2	.4	M	10/26/2006	29 month old given 0.5 ml of flu vaccine which should not be given until child is 36 months old.									Y	10/23/2006			none done	UNK	UNK	none	none	none			1						1	Medication error	FLU3~SANOFI PASTEUR~U2177AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265455	10/26/2006	AK	34.0	34		F	10/26/2006	Dizziness, Nasua, Weezing, Difficulty breathing, Weakness, Fast heart beat.				Y					Y	10/17/2006	10/17/2006	0		UNK	OTH	Pancreliphase, Ortho tri-cyclen lo		Chronic Pancreatitis Allergies: Grass, bee sting, flagyl, amoxicillin, penacilian,  ampicillin, erithromycin, metronidazole		ak200677	1						1	Asthenia; Dizziness; Dyspnoea; Nausea; Tachycardia; Wheezing	FLU3~SANOFI PASTEUR~u2238aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265456	10/26/2006	MI	65.0	65		F	10/26/2006	Inpatient treatment for facial included solumedrol/ranitidine/loratadine; ECF treatment for angioedma included IM solumedrol 125 mg, Benadryl 25 mg IM;  patient was already on mechanical ventilation									Y	10/24/2006	10/25/2006	1	Monitored peak inspiratory pressures on the ventilator as a measure of bronchosonstriction - the facial rash and tongue swelling abated with treatment	UNK	UNK	cortef, asa, xanax, kcl,unkown other meds	seiaure disorder, vent dependent respiratory failure, adrenal insufficiency, COPD	ceftazidime; pre-existing conditions as with illness at time of vaccine			1						1	Angioneurotic oedema; Rash; Tongue oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AF14A2011A~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~unknown~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265457	10/26/2006	CA	65.0	65		F	10/26/2006	large purple area around injection site in upper left arm, area just below injection site substantially swollen, red and itchy. Area about 4 inches beginning approx 2 inches above elbow in a swatch around outer half of arm. Fever for about 3 days. Dizziness 1 day.									Y	10/13/2006	10/13/2006	0		UNK	UNK	Relafen	None	None			1						1	Contusion; Dizziness; Injection site erythema; Injection site reaction; Injection site swelling; Pruritus; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0265459	10/26/2006	HI	0.56	0	.6	M	10/26/2006	Approximately 10 minutes after Prevnar, Pediarix, and Influenza preservative free were given hives at neck with pruritis noted. Within 5 minutes swelling of eyelids noted.  No respiratory problems.  MR received from pediatrician which reveals development of facial hives and swelling of the eyes which began approx. 10 minutes following dose #3 of Pediarix and Prevnar, and dose #1 of preservative-free Flu vaccine. No past hx. of vaccine rxn. Initially treated with po Benedryl, but hives continued to spread to the neck and eyelids.  Infant was then treated with SQ epinephrine and po Prelone after which the hives and swelling began to diminish. No anaphylaxis per MD. Infant was sent home with instructions for Benedryl and Prelone usage.  TC from father 24 hours later reported no further hives.  F/U visit to Ped. 2 days post vax. showed infant continuing to do well without further hives. To F/U with allergist. Diagnosis: Allergic reaction resolved, ? due to egg in Flu vaccine vs. other vaccine preservatives./									Y	10/18/2006	10/18/2006	0	none	UNK	UNK	none	none	none	hives, eyelid edema~Influenza (Seasonal) (Fluzone)~1~0.50~In Patient		1						1	Eyelid oedema; Hypersensitivity; Pruritus; Urticaria	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B064AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2174GA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~Bo8646H~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0265460	10/26/2006	OR	16.0	16		F	10/26/2006	Patient experienced tightness in chest and phlegm in throat approximately 40 minutes after receiving vaccination.  Went to ER and was treated with Benadryl capsules and Zantac tablets.				Y					Y	10/19/2006	10/19/2006	0		UNK	UNK	unknown	none	unknown			1						1	Chest discomfort	FLU3~SANOFI PASTEUR~U2218AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265464	10/27/2006	CT	38.0	38		F	10/24/2006	Information has been received from a licensed practical nurse concerning a 38 year old female with asthma, hypothyroidism and travafloxacin mesylate (Trovan) allergy and a history of pneumonia and positive PPD test (after receiving BCG as a child) who on 10/16/06 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (0.5ml) (lot 651401/0619F), IM in the left arm. Concomitant therapy that day included a dose of Influenza virus vaccine, in the right arm. Other concomitant therapy included albuterol, vitamins, Ortho cyclen, Synthroid. On 10/17/06 the pt had left arm discomfort and was unable to raise her arm. On 10/18/2006 she had a fever of 103.3F and was seen in the office that day. The pt was treated with Keflex by mouth. The pt was sent for blood test for white blood count, which was 18,000. The pt had been admitted to the hospital on 10/19/06 with temp of 104F and vomiting. The pt was treated with IV clindamycin and Vancomycin. A surgical consult had been ordered for a 9x12 cm area of erythema that was red and swollen localized at injection site. There were no complaints of right arm pain in influenza site. It was reported to be unk if she had received Pneumococcal 23v polysaccharide vaccine in the past. At the time of the report, the pt was considered to be not recovered. The reporter considered the pts experience to be an other medical event (OMIC). Additional information has been requested.				Y	Y				Y	10/16/2006	10/17/2006	1	Body temp 10/18/06 103.3F, 10/19/06 104F, WBC count 10/19/06 18000.	OTH	OTH	albuterol, ORTHO-CYCLEN, SYNTHROID, vitamins (unspecified)		Pneumonia, PPD skin test positive, asthma, Drug hypersensitivity, Hypothyroidism.		WAES0610USA11834	1						1	Discomfort; Hypokinesia; Injection site erythema; Injection site oedema; Injection site swelling; Pyrexia; Vomiting; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0619F~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0265465	10/27/2006	NC	59.0	59		F	10/24/2006	Information has been received from a medical assistant concerning a 59 year old female diabetic who on 10/11/2006 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 651319/1007P). Concomitant therapy included influenza virus vaccine administered at the same visit in separate arms (separate sites). On approximately 10/11/06 the pt developed a reaction in arm where the Pneumococcal 23v polysaccharide vaccine was administered, that ranged from redness to blotchiness to pain. Medical attention was sought. it was also reported that the pt had a problem with her blood sugar that was described as she went into diabetic coma but came right out. The pt did not visit the hospital. At the time of the report she was still experiencing symptoms. The medical assistant requested a lot check. No product quality complaint was involved. Upon internal review, diabetic coma was considered to be an other important medical event (OMIC). Additional information has been requested.				Y					Y	10/11/2006	10/11/2006	0		OTH	OTH			Diabetes		WAES0610USA11882	1						1	Condition aggravated; Diabetic coma; Injection site erythema; Injection site pain; Injection site reaction; Rash macular; Blood glucose increased; Condition aggravated; Diabetic coma; Injection site erythema; Injection site pain; Injection site reaction; Rash macular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71033~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1007P~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~1007P~UNK~~UN~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0265468	10/27/2006	MO	2.0	2	1	F	10/17/2006	Pt received flu shot 0.25ml to LAT mom left and went to store was in line and pt began acting really drowsy. Took pt to car stuck her in car seat and noticed that she threw her head back. Mom called pt name and pt was unresponsive says her eyes had rolled back in her head. Called us and was seen in Drs office.  11/28/06 Received medical records from hospital which reveal patient seen in PCP office on 10/16/06 for routine check up & flu shot.  Had cough, slight wheeze & head congestion symptoms for approx 1 day at time of visit w/temp 100.7.  Became very sleepy then unresponsive later same day & went to ER.  Neuro improved in ER but respiratory status worsened & was kept overnight for continued observation & management of asthma. MEDS: singulair & pulmicort for asthma & propanolol for SVT. Xopenex PRN.  GIven Rx for orapred during 10/16/ visit./ss Information received from annual follow up indicates causal relationship unclear.					Y	3			Y	10/16/2006	10/16/2006	0	LABS: CT of head was WNL.  WBC 12.9, neutros 81.3, lymphs 14.7, AST 33, Creatinine 0.3, BUN/Creatine ratio 50	PVT	PUB	Tylenol, Xopenex, Pulmicort, Motrin, Propranolol, Singulair.		SVT, Asthma  PMH: pneumonia, RSV.			1						1	Coma; Eye movement disorder; Leukocytosis; Somnolence	FLU3~SANOFI PASTEUR~U2175HA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0265470	10/27/2006	NY	1.59	1	.6	M	10/26/2006	Pt developed eye lid edema, 2 urticaria in forehead, scalp, 2 at hairline. breath sounds clear, some drooling developed, SC epi given, Benadryl 15mg, Orapred 12 mg, Epinephrine 1:1000 0.1mg.  11/7/06 Received medical records from hospital which indicate patient received Epi, benadryl & Orapred in PCP office prior to being sent to ER for further eval & tx.  Exam revealed facial swelling, puffy eyelids & urticaria.  Received only IV Tagemet in ER.  Improved & d/c home on steroids & benadryl. Dx:  Acute allergic reaction./ss				Y					Y	10/26/2006	10/26/2006	0	Pt sent to ER for fluids, IV Tagamet, Discharged home on Benadryl, Orapred.	PVT	PVT	NONE	NONE	NONE			1						1	Drooling; Eyelid oedema; Face oedema; Hypersensitivity; Urticaria	DTAP~SANOFI PASTEUR~C2627AA~UNK~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2191AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0950F~UNK~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0265472	10/27/2006	IL	64.0			F		On 10/3/06 received both Flu and Pneumococcal vaccine both were injected in the same arm. 2nd injection hurt very bad. Spoke out in pain and the administrator rubbed area vigorously. Injections less than 1/2 apart. approx 6 hours later arm was very warm touch, hurt, had fever, and chills. Next day 10/04/06 woke up in pain and red mark on arm (4x2). Took Tylenol and Motrin. 10/05/06 had linear line on arm and seen Dr was cellulitis was in my lymph glands and arm pit. Prescribed antibiotics. Seen Dr again on 10/10 changed antibiotic, some pain.														UNK	UNK						1						1	Cellulitis; Chills; Injection site erythema; Injection site pain; Injection site warmth; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265473	10/27/2006	IL	57.0	56		M	10/24/2006	Red rash, rectal area and hairline. progressed to arms and body. Developed hives TC to MD given prescription for methylprednisolone PO.									Y	10/18/2006	10/19/2006	1		PUB	PUB	NONE	NONE				1						1	Erythema; Rash; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70279~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265474	10/27/2006	GA	64.0	64		F	10/22/2006	Site of injection is red, swollen, hot and hurts in right arm.									U	10/20/2006	10/21/2006	1		OTH	OTH	Percocet, Flexeril, Lidoderm, Zoloft, Ativan.					1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U2256AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1048P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265475	10/27/2006	NY	4.0	3		F	10/23/2006	Flu vaccine given on 10/13/2006, torticollis developed on 10/18/2006, seen by me on 10/18/2006 symptoms, and signs subsided in 36-48 hours.									Y	10/13/2006	10/18/2006	5		PVT	PVT	NONE	NONE	NONE			1						1	Torticollis	FLU3~SANOFI PASTEUR~U2178AA~3~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265478	10/27/2006	IA	11.0	11		M	10/23/2006	Redness at left deltoid.				Y					U	10/21/2006	10/22/2006	1		PVT	PVT	Tylenol, PRN	NONE	NONE			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U2165DA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265479	10/27/2006	MI	65.0	64		F	10/22/2006	Her left arm became severely sore (almost unbearable, she had a high fever that first evening, on 10/19/06 her arm turned red and swelled up. She has been taking Motrin and putting ice on her arm. The swelling, pain and fever have all went away.									Y	10/18/2006	10/18/2006	0	NONE	OTH	PVT		NONE	NONE			1						1	Erythema; Oedema; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2256AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0619F~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265480	10/27/2006	WI	2.0	2	.4	F	10/23/2006	Pt received Flu immunization in am and then 4 hours later developed hives, coughing, wheezing, difficulty breathing. Child taken to ER and received Albuterol neb, Benadryl PO and Prelone PO. Child went home on Benadryl and Prelone PO x 4 days and recovered well.  Final dx: acute urticaria & bronchospasm./ss				Y					Y	10/20/2006	10/20/2006	0		PVT	PVT		NONE	Dermatitis			1						1	Bronchospasm; Cough; Dyspnoea; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U2174DA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265481	10/27/2006	NJ	31.0	31		F	10/26/2006	At approx 2-3 hours after receiving the vaccine began to have a dry cough, sore throat , Wheezing, temp went to 103. Took Benadryl, went to ED had IV, Tylenol, chest X ray and Labs.  1/29/07 Received medical records from hospital which reveal patient seen in ER on 10/17/06 with cough w/wheeze, fever of 103, myalgias & sore throat.  Tx w/IVF, antipyretics & neb tx.  Improved & d/c to home to f/u w/PCP if no improvement. FINAL DX: febrile illness s/p flu shot.				Y					Y	10/17/2006	10/17/2006	0	Chest X ray, Labs CBC LABS: CXR neg.  WBC 8.4, neut 84.7, lymph 11.7.  Strep screen neg.	OTH	OTH		NONE	Asthma as child years and last environmental seasonal.			1						1	Cough; Pharyngolaryngeal pain; Pyrexia; Wheezing	FLU3~SANOFI PASTEUR~U2165EA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265482	10/27/2006	NJ	39.0	39		F		9 hours after vaccine sever pain entire arm and neck, fever 1005 oral, nausea, chills, body ache, insomnia, slowly recovered over 3 days, 1st time Pneumonia shot gets Flu vaccine every year.									Y	10/16/2006	10/16/2006	0		OTH	UNK	Effexor, Flonase, Opituar		Sarcoidosis, Vertigo 3x in 2 yrs.			1						1	Chills; Insomnia; Nausea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2213AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1037P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265484	10/27/2006	MA	40.0	39		F	10/24/2006	Received Fluarix IM right deltoid 10/18/06 at 8:30 am woke with pain at 2:21am 10/19/06 with right arm pain extending to axilla. Treated with erythromycin. with resolve of pain in 2 days.									Y	10/18/2006	10/19/2006	1		PUB	UNK	NONE	NONE	NONE			1						1	Injection site pain; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~220AB~3~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0265485	10/27/2006	NM	78.0	78		M	10/23/2006	Given flu shot 10/19/06 comes into clinic 10/23/06 because hematoma to left deltoid and to above elbow. States decrease soreness today. Ecchymosis on left arm 6:x9 1/2, Pain x 2 days, unable to put arm over head decreased ROM.									Y	10/19/2006	10/19/2006	0	On Coumadin Therapy 10/17/06 INR 2.39	PUB	PVT			On coumadin therapy, Diabetes.			1						1	Injection site haemorrhage; Injection site pain; Joint range of motion decreased	FLU3~SANOFI PASTEUR~U2192AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265486	10/27/2006	MA	43.0	42		F	10/24/2006	Felt tired, chills, fever, headache, nausea no treatment, symptoms spontaneously subsided in about 12 hours.									Y	10/18/2006	10/18/2006	0		PVT	UNK						1						1	Chills; Fatigue; Headache; Nausea; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~220AB~2~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0265487	10/27/2006	LA	69.0			U		Given an Influenza virus vaccine on 10/19/06 pt complained of burning after injection. 10/20/06 presents to work and has large hematoma, red raised area.									Y					PUB	OTH						1						1	Injection site haemorrhage; Injection site swelling; Thermal burn	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70091~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265489	10/27/2006	NY	50.0	50		F	10/27/2006	Note: Have had a flu shot every year for at least 10 yrs.  Started with chills 8 hours after shot, went to a fever, sweats, little nausea, headache.  What woke me up during the night was my fingers swelled so much I couldn't get my rings off.  My ring finger (left hand, had shot in left arm)was so tight, it was discolored, after 1 hour I finally got engagement ring off (which is normally very loose), still couldn't get wedding band off. Got left pinky ring off.  Right hand was not bad, but by morning,it was a little swollen, got those rings off in the shower.  Ended up going to a jeweler to get my wedding band cut off because it was so tight, the jeweler said there was no way it was coming off.  That ring was tighter than the engagement ring, however, I have always been able to get if off in the past.  The swelling has gone down and the rest of the symptoms were gone within 24 hours.  I haven't tried to put my rings on yet.									Y	10/25/2006	10/25/2006	0	None	UNK	UNK	Zeita, zyrtec, Urocit K, vitamins	None	high cholostrol, kidney stones, sinus allergies, allergic reaction to codine, demoral, some anethistics, sulfur			1						1	Chills; Headache; Hyperhidrosis; Nausea; Oedema peripheral; Pyrexia; Skin discolouration	FLU3~PFIZER\WYETH~U2213AA~2~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0265490	10/27/2006	VA	78.0	78		F	10/27/2006	Syncope, code blue Code team called 12/12/06 Received medical records from hospital which reveal patient admitted 10/19/06-10/24/06.  Received flu shot on 10/20.  Patient experienced syncope, unresponsiveness, bradycardia & hypotension approx 1 hours later.  Cardio consult done.   Hospital course complicated by hypotension secondary to meds & by UTI. Final Dx: syncope secondary to sick sinus syndrome s/p pacemaker on 10/20/06 for AV block; coronary artery disease; HTN; high cholesterol; anemia; ;hypothyroidism; UTI; and SIADH.							Y		Y	10/20/2006	10/20/2006	0	ECG, Pulse Ox, LABS: CT scan, MRI & MRA of head were WNL. EKG & enzymes all WNL.  Na 129.  EKG revealed first degree AVB.	UNK	UNK	clonidine, mirtazapine, isradipine, pregabalin, simvastatin,pantoprazole,furosemide,levothyrxine, cetirizine, isosorbide dinitrate, enoxaparin, docusate sodium	Coronary artery disease Hypertension Hypothyroidism	SULFA DRUGS PMH: cardiac cath 4/06 showed 3 vessel disease, neg stress thallium test.  Drug eluting stent placement x 4.  Arthritis; mild mitral regurgitation; left atrial enlargement.  S/P renal artery stening 5/06.			1						1	Anaemia; Atrioventricular block first degree; Bradycardia; Coronary artery disease; Hypercholesterolaemia; Hyponatraemia; Hypotension; Hypothyroidism; Laboratory test abnormal; Syncope; Urinary tract infection	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA220BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0265491	10/27/2006	WA	38.0	38		F	10/27/2006	She had flulike symptoms a few hours after the vaccine was administered.  She progressively got worse and went to her private physician after a few days.  He prescribed her antibiotics, which she has been taking.  She now has a respiratory infection.				Y					U	10/14/2006	10/14/2006	0		MIL	MIL						1						1	Influenza like illness; Respiratory tract infection	FLUN3~MEDIMMUNE VACCINES, INC.~500431P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0265492	10/27/2006	WI	35.0	35		F	10/27/2006	Recieved Flumist. Within 16 hours if recieving mist noticed very blood breast milk.  No trauma, no new meds started, nothing changed.  Had been nursing at this time 10.5 months.  Sice bloody milk lactation suppply has drastically decreased.									U	10/18/2006	10/19/2006	1	n/a	UNK	UNK	none	none	none			1						1	Breast haemorrhage	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0265494	10/27/2006	AZ	36.0	36		F	10/27/2006	I was given the Influenza vaccine in my left arm and the Pneumococcal vaccine in my right arm.  Reaction occured to the Pneumococcal vaccine. Redness and swelling at the injection site.  Hard lump/welt developed after a couple hours at injection site.  Area was swollen and hot, and painful to the touch.  Red area increased in size over the next few days.  The day of the injection I felt like I was running a fever (chills).  Flu like symptoms (fatigue, muscle aches).  Had headache on and off all week.  Injection was given on Monday, symptoms starting to improve the following Friday (current date).  Redness has improved.  Still can feel a lump and it is tender to touch.  Still warm to the touch.  Still have a headache.									Y	10/23/2006	10/23/2006	0		UNK	UNK	Birth control; Maxalt - PRN;	History of migraines.	Penicillin allergy; cephlasporin allergy; Soma allergy; Migraines.			1						1	Chills; Fatigue; Headache; Injection site erythema; Injection site induration; Injection site mass; Injection site swelling; Injection site warmth; Myalgia; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0265495	10/27/2006	CA	28.0	28		F	10/27/2006	10/27/06:  Employee in Employee Health Services to report generalized rash and pruritis and attributes symptoms to receipt of the flu vaccine given 3 days ago. On 10/24/06 employee received the inactivated flu vaccine administered in the Right Deltoid. Employee denied any contra-indications to receiving vaccine. No signs of rash/redness at injection site. Employee noticed rash and itching on noc of 10/26/06 after returning from her Beautician.  Denies respiratory symptoms.  Denies use of new products i.e shampoos, soaps, perfumes.  Employee was referred for further evaluation.				Y					Y	10/24/2006	10/26/2006	2	N/A	UNK	UNK	Celexa times 2months.  Last dose 1 week ago. Birth Control discontinued approx. 1 year ago.	None	No Known Allergies			1						1	Injection site erythema; Injection site rash; Pruritus; Rash	FLU3~SANOFI PASTEUR~U2218AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265496	10/27/2006	CA	36.0	36		M	10/27/2006	I received a flu shot at 1:30 pm. Around midnight, I was suffering from a fever of 101.9 degrees all night. The next day I still had a fever of about 101.1 until noon.  The flu shot was adminsitered at my workplace.									Y	10/25/2006	10/26/2006	1		UNK	UNK						1						1	Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0265497	10/27/2006	TX	37.0	36		F	10/24/2006	Received the Influenza Vaccine in the left Deltoid on 10/22/06.  On 10/24/06  the injection site has a 10cm oval erythema area and the entire arm is edematous and tender to touch.				Y					Y	10/22/2006	10/24/2006	2	All labs drawn were normal	UNK	UNK	HCTZ Toprol Pramarin	None	High blood pressure Seasonal allergies Codeine Morphine			1						1	Injection site erythema; Oedema peripheral; Tenderness	FLU3~SANOFI PASTEUR~U2195AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265499	10/27/2006	MS	75.0	75		M	10/27/2006	75 y.o male came back to the health department c/o twenty min. after taking the flu and pneumonia shot his right jaw began to swell. On assessment public health nurse, noted the right jaw is edematos. Patient tell nurse he gets the flu shot every year, but this is the first time he has ever gotten the pneumonia shot. He got the pneumonia shot in the RT Deltoin and is RT jaw is swelling. I contacted patient's PMD. I contacted Our Dist. health Officer. Dr.  told me to get the patient to ER. PHN transports pt. to ER. By now his lip was swelling and it had become more difficult for the pt. to speak. He remain alert and oriented. I called one of his friends to come to the ER while pt. went in to see ER doctor. He was given two inj. and prescriptions x 3 to get filled.				Y					U	10/25/2006	10/25/2006	0	According to Patient, he recieved two injections at ER. He has prescriptions for:Benadryl, Prednisone, and Amlodipine.	UNK	UNK	Lotrel5/20		NKA DX: HTNCVD			1						1	Face oedema; Speech disorder	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70279~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0607R~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0265500	10/27/2006	GA	1.03	1	.0	M	10/27/2006	Mother states noticing rash on child face then spreading to torso and arms, states rash started about 2days ago, states mild fever. Mother brought child to health dept today, 10-27-06. Rash is pink, is starting to fade from face but still highly visible in torso. No treatment given, advised to give acetaminophen for fever.									U	10/16/2006	10/25/2006	9		UNK	UNK						1						1	Pyrexia; Rash	FLU3~SANOFI PASTEUR~U2180AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1009R~3~IM~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0832F~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0832F~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0265501	10/27/2006	MD	3.0	3		M	10/27/2006	He received the Flu Shot on 10-17-06.  That evening, he complained of some pain and the injection area appeared okay.  The following morning, his upper thigh had a large red circle around the sight, he complained of pain, and he was limping after getting out of bed.  We contacted his PCP who advised us to continue to monitor the area, which now appears okay.  They also suggested we complete this online form to report the incident.									Y	10/17/2006	10/17/2006	0		UNK	UNK		None	None			1						1	Gait disturbance; Injection site erythema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~3~~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0265502	10/27/2006	WA	38.0	38		F	10/27/2006	Fever 103.0 (F)X4 days with onset <24 hours from immunization. Diarrhea, fatigue, chills. Swelling from left deltoid to elbow with redness and tenderness to site. Patient remains symptomatic 4 days post immunization.									N	10/23/2006	10/24/2006	1		UNK	UNK		none	none			1						1	Chills; Diarrhoea; Fatigue; Injection site erythema; Injection site pain; Oedema peripheral; Pyrexia	FLU3~SANOFI PASTEUR~U2240AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2609AA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0265503	10/27/2006	IL	37.0	37		F	10/27/2006	10/252006 began to feel bad achy all over, no fever but had headache and nauseated.  10/262006 headache worse with stiff neck. At 5 pm both eyes and lip became swollen.  feels like she had huge lips  Letft dark blue circle uder her left eye on 10/27/2006.  Denies difficulty breathing but states she could not get a deep breath.  On 10/27/2006 states sill fells achy but not nauseated and headache is 1/2  of what it was yesterday.  Facial swelling going down.  Feels like she can breath normally today.  Advised to watch for difficulty breathing, fever, stiff neck and headache this weekend.  If occurs should go to the physician immediately									Y	10/19/2006	10/25/2006	6	did not go to a physician	UNK	UNK		no				1						1	Dyspnoea; Eye oedema; Face oedema; Headache; Musculoskeletal stiffness; Nausea; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70384~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~SMITHKLINE BEECHAM~ahbv346ba~1~IM~LA~HEP B (ENGERIX-B)~1|MMR~MERCK & CO. INC.~0537F~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TDAP~SANOFI PASTEUR~C2456AA~1~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0265505	10/27/2006	TX	29.0	29		F	10/27/2006	Employee received flu shot 7 days ago and broke out with fine red rash on trunk that itches a great deal 2 days later.  No other symptoms noted.  Rash spread to upper extremities.									Y	10/20/2006	10/22/2006	2		UNK	UNK		none reported	none reported			1						1	Erythema; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA216AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0265507	10/27/2006	TN	47.0	47		F	10/27/2006	Approximately ten minutes after receiving the vaccine the patient came back to pharmacy stating that she felt dizzy. She sat down and then when asked how she felt she says she has a history of seizures and felt like she was about to have a seizure.  She complained of blurred vision, shortness of breath, tremor. EMS arrived shortly after to assist patient and take her to ER. Patient also stated she has history of diabetes.  She stated she checked blood sugar prior to arriving to pharmacy and said it was okay.				Y					U	10/27/2006	10/27/2006	0		UNK	UNK	UNKOWN					1						1	Dizziness; Dyspnoea; Tremor; Vision blurred	FLU3~SANOFI PASTEUR~U2274AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265508	10/27/2006	AK	55.0	55		F	10/27/2006	Patient developed fever of 102 degrees farenheit. Injection site with increased swelling and erythema next day.  Treatmnent included OTC antihistamine and icing to area.									U	10/23/2006	10/24/2006	1		UNK	UNK	Effexor, Synthroid, Lipitor, Voltarin, Flexeril, Trazodone, ERT, Prevacid, Vicodin, Gabatine, generic Allegra	NONE	Anaprox, Stadol, Demerol			1						1	Injection site erythema; Injection site swelling; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69425~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0089F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265509	10/27/2006	CA	16.0	16		M	10/27/2006	This is a 16 year old male patient who is trach-dependent secondary to an inoperable C1-C2 juvenile pilocytic astrocytoma with significant radiation necrosis and neurologic sequelae.  His vaccination was given 10/16/06 11:00.  Patient developed red, itchy rash the following morning.  He was given IV Benadryl and Atarax with little improvement.  Infectious disease was consulted.  The rash persisted for 3 days, then resolved completely.  No respiratory nor mucosal involvement.  Prior to the rash, he had had about 1 week of nausea, slightly loose stools and a sore throat, and was finishing a course of Ceftazidime and Ciprofloxacin for Pseudomonas tracheitis.  No new medications nor exposures. 12/8/06 Received medical records from hospital which reveal patient was rehospitalized on 11/3/06 for trach reconstruction & decannulation. Was initially dx w/transverse myelitis 12/05 then MRI & biopsy revealed JPA 1/06.  Patient has remained hospitalized from 2/06 first as inpatient then into rehab.  Was scheduled to reenter rehab s/p trach reconstruction.				Y					Y	10/16/2006	10/17/2006	1	Mycoplasma titers negative Chest x-ray negative	UNK	UNK	Baclofen Fluoxetine Multi-vitamin with minerals Miralax Nystatin powder Lansoprazole Ciprofloxacin ear drops Ceftazidime Ciprofloxacin	Loose stools Sore Throat Nausea	Inoperable C1-C2 juvenile pilocystic astrocytoma Pseudomonas tracheitis Tracheostomy-dependent Subglottic obstructive collapse Acquired central hypoventilation Left hemiparesis Right upper extremity weakness Radiation necrosis Anxiety/depression PMH: inoperable juvenile pilocytic astrocytoma(JPA) at C1-C2, s/p radiation tx, radiation necrosis; s/p hyperbaric O2 therapy; & central hypoventilation s/p trach.			1						1	Bacterial infection; Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA201AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0265512	10/27/2006	CA	64.0	64		F	10/27/2006	SWELLING OF ARM, RED, HOT, PAINFUL, PATCH.  FEVER OF 100-101 DEGREES F FOR ONE NIGHT WITH SEVERE HEADACHE.  GENERAL MALAISE FOR 4 DAYS AFTER SEVERE REACTION.									Y	10/20/2006	10/21/2006	1		UNK	UNK	SYNTHOID, ESTRATEST, LIPITOR, HYDROCHLORTHIAZIDE, EFFEXOR	NONE	NONE			1						1	Erythema; Headache; Injection site warmth; Malaise; Pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U22133AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1649P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265514	10/27/2006	WV	61.0	0	.0	F	10/27/2006	My arm starting hurting severly as soon as nurse injected medicine in my arm.  Pain was very bad.  Arm at injection site was hot to touch, and blotchy hives around the site.										10/25/2006	10/25/2006	0		UNK	UNK	altace, lovastatin, plavix, zoloft, zanax, lasix, klor-con	none	Recovering from heart surgery, which Dr. put stent in heart blockage on Aug 7th, 2006, otherwise good health.			1						1	Injection site warmth; Pain; Rash macular; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265531	10/27/2006	TN	68.0	67		M		Left arm edema, erythema and heat covering entire distal to shoulder and immediately proximal to elbow. Pt c/o discomfort.									U	10/25/2006	10/25/2006	0		PVT	UNK		Hypolipidemia				1						1	Discomfort; Injection site erythema; Injection site oedema; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69424~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1007P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265532	10/27/2006	VA	68.0	68		F	10/27/2006	Client Developed itchy facial skin and swelling and redness on the left side of the face. Facial skin is also bumpy per clients report.									U	10/25/2006	10/25/2006	0		PUB	PUB	Tamoxifen, Detrol, Prozac, Fosamax.	NONE	NONE			1						1	Erythema; Face oedema; Rash pruritic	FLU3~SANOFI PASTEUR~U2256AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265533	10/27/2006	TX	38.0	37		F	10/27/2006	10/02/2006 received Fluzone and Pneumovax. 10/03/06 left arm turned red, swollen, 10/04 visit to MD, 10/04 or 5 went to ER, 10/05 went to ER again and was admitted, 10/06 discharged with RX for Clindamycin 300mg and Bactrim DS.									Y	10/02/2006	10/03/2006	1		OTH	UNK						1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U2180AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0391F~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265534	10/27/2006	VA	74.0	73		F	10/27/2006	Redness at site right arm, pain at site right, swelling at site right arm, red streaks from site pm of 10/26/06 gone on 10/27/06.									Y	10/26/2006	10/26/2006	0		PVT	PVT						1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71647~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1007P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265535	10/27/2006	CA	0.71	0	.7	F	10/27/2006	Hives, immediately, following influenza vaccine, resolved immediately with Benadryl PO. MR received revealing healthy infant with several food allergies and eczema, who developed hives within a few minutes of receiving Fluzone. Hives resolved quickly after PO Benadryl. F/U 1 week later with allergist who provided Epipen Jr. PRN, as well as Albuterol, and antihistamines PRN Primary DX: Influenza Vaccine  Allergy.									Y	10/24/2006	10/24/2006	0	NONE	PVT	UNK		Hives Urticaria	hives, food allergies, eczema			1						1	Hypersensitivity; Urticaria	FLU3~SANOFI PASTEUR~U2174DA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265536	10/27/2006	WA	80.0	80		F	10/26/2006	Redness, swelling, and warmth covering entire deltoid region of left arm. Vaccine administered at 2:35pm and pt reports symptoms appeared in the evening of the same day.									U	10/25/2006	10/25/2006	0	NONE	OTH	UNK		NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U2218AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0320F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265537	10/27/2006	OR	52.0	52		F		1 day after felt tired and achy, slept all day, day 2 broke out in hives all over body, 1 dose of Prednisone not helpful, 2 dose of prednisone helpful still on prednisone.									Y	10/11/2006	10/12/2006	1	NONE	UNK	UNK		NONE	Fibromyalgia, Stroke factor V leiden, Depression.			1						1	Fatigue; Pain; Somnolence; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71034~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265538	10/27/2006	CO	42.0	42		F	10/25/2006	Mild cellulitis pt started on Keflex.									U	10/23/2006	10/24/2006	1	NONE	PVT	PVT	NONE	NONE	Heart Murmur			1						1	Cellulitis; Cellulitis	FLU3~SANOFI PASTEUR~U2219AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2219AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0265518	10/28/2006	FL	3.0	3		M	10/28/2006	On Wednesday 10/25/06 received the Flu vacine (via shot) along with his 3 year old twin brother and 5 year old sister.  All children were perfectly healthy prior to the vacination.  By early evening he was showing a 103 degree tempature, which progressively worsened.  On Friday night simptoms included sore throat with swelling (unable to swollow), aches, pains, continued high fever requiring a trip to the emergency room, where they suggested it might be a virus and (incorrectly) prescribed antibiotics.  We did not fill the antibiotic prescription as we know they have no affect on a virus.  Giving him over the counter Tylenol and Motrin throughout this event provided very little if any releif.  On Saturday morning we returned to the doctor where the vaccine was received.  The doctor ran throat cultures and performed an complete checkup determining that he has the flu.  I understand that the vaccine (shot) is prepared with dead cultures, but find it very difficult to believe that (being the only one sick in the home at this time) this event was not due to the vaccine.  He has had fever reaction to the vaccine in the past, but nothing like this.  The child has just returned from the doctor and now has a 104.2 degree tempature.  My child is more sick then he has ever been in his life and I am extremely upset that the media representation of this vacine does everything to insure the public of it's safety and nothing to report that there is a chance (however slight) that an adverse reaction could include full blown Flu.  I am also extremely concerned for my childs saftey in the immediate since, as well as longer term issues.  We will now be returning to the emergency room for the second time to try and obtain some relief.				Y					U	10/25/2006	10/25/2006	0	May be obtained from emergency room, Dr., as well as the next emergency room.	UNK	UNK		NONE	NONE			1						1	Dysphagia; Pain; Pharyngolaryngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~2~~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0265519	10/28/2006	CA	6.0	72		M	10/28/2006	Upper right arm had extreme pain in muscle at vaccine administration site of Pneumococcal Polysaccharide Vaccine. Unable to lay on arm when sleeping do to extreme pain for approx 8 hrs beginning 7 hrs after vaccination was given at 10 AM 10/26/2006. At approx 8 AM the next day 10/27/2006, the skin on the right arm beginning at the vaccination site proceding 3 inches wide and 7 inches down the arm was raised with red blotches that were warm to touch and itched. Application of Triamcinolone 0.1% Ointment reduced the skin swelling to onlya few red raised blotches after 12 hours as of 10 AM on 10/28/2006.										10/26/2006	10/26/2006	0		UNK	UNK						1						1	Feeling hot; Injection site pain; Pruritus; Rash macular	FLUX~UNKNOWN MANUFACTURER~~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265521	10/28/2006	MO	59.0	59		F	10/28/2006	Intense pain shooting through entire arm, sometimes into shoulder, sometimes into back at upper shoulder blade area, arm and hand weakness. Unrelieved by medications, ice applied several times, heat alleviated only slightly. Joint stiffness and weakness in shoulder, arm and hand. I received flu shot 12 hours ago and it's no better. Began about 5 minutes after receiving shot - just after reaching my car in the parking lot. 3 Advil tablets every 4 hours have not helped. It's the weekend and I live alone. I have no money for emergency room care. I'm really scared of this. I called ask a nurse but they didn't know what to have me do other than ice, heat and pain meds. They don't help at all.									N	10/28/2006	10/28/2006	0		UNK	UNK	vitamins	none	scoliosis, fibromyalgia, arthritis			1						1	Joint stiffness; Pain; Shoulder pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0265522	10/29/2006	OK	55.0	55		F	10/29/2006	Vaccination in A.M. of 10/26/06.  Reaction to pneumococcal polysaccharide vaccine.  Specific vaccine information unknown to patient.  Red inflammation up to 3 diameter as of 10/29/06; temp. to 102F; swelling and soreness in arm where vaccination was administered; treatment recommended: (10/28/06-1st visit) ice pack, tylenol/motrin rotation, lortab; (10/29/06-2nd visit) hot pack, bactrim.										10/26/2006	10/27/2006	1		UNK	UNK		None.				1						1	Pain; Pyrexia; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0265523	10/29/2006	FL	65.0	65		F	10/29/2006	High fever and chills beginning evening of injections and lasting three days; swollen red upper arm at site of pneumonia injection from day of injection to present time; Motrin, liquids and bed rest as treatment.									U	10/25/2006	10/25/2006	0	None	UNK	UNK	None	None	None			1						1	Chills; Injection site erythema; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~5~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0265524	10/29/2006	ID	57.0	57		F	10/29/2006	swelling at sites muscular pain at sites and throughout the body nausea chills for 3 days sweats-temperature at 102 for 2 days vertigo migraine and cluster headaches severe fatigue Sleep Advil Inhaler									U	10/25/2006	10/25/2006	0		UNK	UNK	Singular, Advair, Flonase, Vivelle	At the time of the vaccination I was healthy.	sulfa, latex, food allergies (not eggs),grasses, pollens, tree molds, perfumes, paints, dander			1						1	Chills; Fatigue; Headache; Injection site pain; Migraine; Nausea; Pyrexia; Vertigo	FLU3~SANOFI PASTEUR~~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265525	10/29/2006	VA	63.0	64		F	10/29/2006	Flu shot received on 10/24/06 at 1:45PM. At approximately  6:00 PM began severe throat pain, swelling of the lips and mouth area, reddening and tearing of the eyes. Constricted breathing. Taken to emergency room and treated and released after 3 hours. Steroid treatments followed and symptoms went way after approximately 48 hours.				Y					Y	10/24/2006	10/24/2006	0		UNK	UNK		NONE	NONE			1						1	Face oedema; Lacrimation increased; Ocular hyperaemia; Pharyngolaryngeal pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0265528	10/30/2006	OH	46.0	46		M	10/24/2006	Day after pneumonia shot, sore arm, 2 days later left arm swollen, red and hot to the touch starting about 1 from where pneumonia shot was given. Red streaks going down arm towards hand. Went to urgent care. Was told by doctor it was either a reaction to the needle or to the medicine. Diagnosed with cellulitis and put on Cephalexin and Allegra, when I spoke with pt on 10/24 swelling gone and almost back to normal.				Y					Y	10/17/2006	10/18/2006	1		OTH	PVT	Allergy shot					1						1	Cellulitis; Erythema; Injection site erythema; Injection site oedema; Injection site pain; Injection site reaction; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA202AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0743F~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0265530	10/30/2006	WY	44.0	43		F	10/26/2006	Red, warm flat rash left upper arm. with flushing and slight raised are of rash to chest and neck. Seen and observed in ED, TX with Anti histamine.									Y	10/25/2006	10/25/2006	0	Allergic reaction	PUB	PVT		NONE	Thermisol allergy only in contact solution.			1						1	Flushing; Hypersensitivity; Injection site erythema; Injection site rash; Injection site warmth; Rash erythematous	FLU3~SANOFI PASTEUR~U2218AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265555	10/30/2006	AZ	29.0	28		U		Swollen arm, blotchy skin, severe pain.									N	10/26/2006	10/26/2006	0		OTH	OTH		NONE				1						1	Oedema; Pain; Rash macular	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0265558	10/30/2006	CT	40.0	40		F	10/25/2006	Seriousness criteria other medically significant (OMIC). Initial report received on 10/17/06 from a family member of the pt who is also a health care professional. A 40 year old female pt, with a past medical history of asthma and dust and pollen allergies, had received a left deltoid injection of Fluzone SV 2006-2007 lot number unk, on either 10/9/06 or 10/10/06. Fifteen minutes post vaccination, the pt experienced wheezing, and itchy throat, cough, nasal congestion and chest tickle. The event required a physician examination. She was treated with a Zopinex inhaler, and the symptoms resolved after 45 minutes. The pt had experienced the same symptoms following an cortisone injection two weeks prior to these events. Relevant diagnostic testing included an IgE of 630 and neg testing for egg and chicken allergies. The pt recovered from the event.				Y					Y	10/09/2006	10/09/2006	0		PVT	UNK	Zopinex inhaler		The pt has a history of asthma and allergies to dust and pollen.		200602700	1						1	Chest discomfort; Cough; Nasal congestion; Pruritus; Wheezing	FLU3~SANOFI PASTEUR~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265559	10/30/2006	GA	34.0	34		F	10/26/2006	Seriousness criteria other medically significant (OMIC). Initial report received on 10/17/06 from a health care professional. A 34 year old female pt, with a history of latex allergy, had received an IM injection of Fluzone SV 2006-2007, lot number U2165CA, on 10/17/06. Ten minutes post vaccination, the pt experienced lightheadedness and shortness of breath. She was treated with IV Benadryl and transported to the ER. At the time of this report, the pt had not recovered.				Y					N	10/17/2006	10/17/2006	0		UNK	UNK			The pt had an allergy to latex. She had no illness at the time of vaccination and was on on other medications.		200602709	1						1	Dizziness; Dyspnoea	FLU3~SANOFI PASTEUR~U2165CA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265563	10/30/2006	ND	94.0	94		F	10/26/2006	Pt received flu vaccine on 10/25/06. Today was stroke like symptoms. Left sided weakness et paralysis. CT neg for stroke. Seen in ER with suspicion of stroke. Doing well until found this morning with left facial droop and left side hemiparesis. Presented with extreme weakness of left side. PMX significant for many episodes of ITA, HX of atrial fibrillation. Has a pacemaker. HTN. CT head in 2005 showed chronic changes of white matter without any acute changes suggestion of stroke or hemorrhage. PE: WNL except for unable to elicit Babinski signs. Neurological exam obvious droop to left, weakness, strength is 1/5 in left and upper extremities. Responds to commands, follows commands. Alert but somulant.  Assessment: TIA versus CVA. Transferred to stroke center at St. Alexius.  At time of injection patient lived in assisted living, after adverse event she was hospitalized and later died.	Y			Y	Y				N	10/25/2006	10/26/2006	1	Seen in ER with suspicion of stroke. Doing well until found this morning with left facial droop and left side hemiparesis. Presented with extreme weakness of left side. PMX significant for many episodes of ITA, HX of atrial fibrillation. Has a pacemaker. HTN. CT head in 2005 showed chronic changes of white matter without any acute changes suggestion of stroke or hemorrhage. Blood sugar 144. PE: WNL except for unable to elicit Babinski signs. Neurological exam obvious droop to left, weakness, strength is 1/5 in left and upper extremities. Responds to commands, follows commands. Alert but somulent.  Assessment: TIA versus CVA. CT scan without contrast: prominent deep white matter changes. Compared to study of 3/28/05: significant degree of decreased density in subcortical and perventricular deep white matter regions bilaterally suggesting chronic small vessel ischemic changes. No evidence of mass, hemorrhage or definite areas of acute ischemia.	PUB	UNK	Lasix, ASA, Toprol, Nitro Furitoin, KU.	UTI	PMX significant for many episodes of ITA, HX of atrial fibrillation. Has a pacemaker. HTN.		ND0614	1						1	Blood glucose increased; Cerebrovascular disorder; Computerised tomogram abnormal; Death; Facial palsy; Hemiparesis; Hemiplegia; Neurological examination abnormal; Somnolence; Transient ischaemic attack	FLU3~EVANS VACCINES~69425~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0265564	10/30/2006	IN	80.0	80		M		Severe red rash, hives, drop in blood pressure, and pulse, dizziness, weakness, nausea, faintness.				Y	Y	1			Y	10/13/2006	10/13/2006	0		OTH	PUB	Omeprazole DR, Finasteride, Lisinopril.					1						1	Asthenia; Blood pressure decreased; Dizziness; Erythema; Heart rate decreased; Nausea; Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0265565	10/30/2006	PR	55.0	55		M	10/20/2006	High blood pressure, high cholesterol, Insomnia, vision problem, diabetes mellitus, arthritis, pain right and left shoulder, pain feet, like a electrical shock. Initial report includes documentation of sick visit on 16 Jan. 2003 for fever and cough.  Txd with phenergan. Next visit 10 June 2003 discussing diabetes, HTN, and high cholesterol dx in Feb/March 2003, which placed him on limited duty to monitor response to diabetes tx. MR received from VA documenting multiple office visits for c/o dizziness, abdominal pain, chest pain, injury from bike accident, hand numbness and tingling, toenail avulsion, ear pain, sore throat, dysphagia, h/a, and upper and lower back pain between 06/2004 and 11/2006. Had carpal tunnel surgery 07/2006. Assessments: As above in PMH (Diabetes Mellitus dxd in 2003, HTN, lumbar disc herniation, bilateral rotator cuff tears repaired in 2004,depression, anxiety, hypercholesterolemia, elevated LFTs). As soon they put me the shoot my blood sugar raise until 557 and my joint start to pain red hard.  After that course me surgery in both shoulder and carpal tunnel in right hand also I have 3 bulgens on back (disk) I lost memory and deppresion I check with VA for this sickness I have to wear glasses because I lost vision  Per 60 day follow up: I never feel symptoms of diabetes, only after the vaccination occur. I sent evidence that all year, that I will be activated during regualr army and national guard never feel diabetes symptoms. Also army reserve. Those events both sugery on my shoulders and carpal tunnel surgery cause me highly depression.			Y	Y				Y	U	01/10/2003	01/16/2003	6	Glucose levels in the mid 100's to 200's, otherwise as in PMH.	MIL	MIL	NONE		PMH: Diabetes Mellitus dxd in 2003, HTN, lumbar disc herniation, bilateral rotator cuff tears repaired in 2004, depression, anxiety, hypercholesterolemia, elevated LFTs.			1						1	Arthritis; Blood cholesterol increased; Blood glucose increased; Cough; Diabetes mellitus; Hypertension; Insomnia; Pain in extremity; Paraesthesia; Pyrexia; Shoulder pain; Visual disturbance	ANTH~EMERGENT BIOSOLUTIONS~~UNK~UN~UN~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|OPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~POLIO VIRUS, ORAL (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~UN~UN~TD ADSORBED (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~UN~UN~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|YF~SANOFI PASTEUR~UB0320AA~UNK~UN~UN~YELLOW FEVER (YF-VAX)~1	USA	Life Threatening,Disabling	Influenza
0265566	10/30/2006	NJ	3.0	3		M	10/30/2006	Patient is a 3 year old male who had a seizure of 3 minutes on 10-25-06 PM. This progressed to cyanosis and no respirations. Mother gave 2 rescue breaths and then did not find the carotid pulse. She initiated CPR times 2 minutes. EMS arrived and found pulse and now breathing but posticial. Transported to Hospital and admitted overnight. DC DX: for 10/25-10/26/06 Febrile Seizure HX of febrile seizures times three in the past. Normal EEG 7/05. Previously followed by neurologist. URI symptoms for up to one week prior to seizure.  EEG pending CXR: normal chest  EKG normal Labs WNL with AST 45.					Y	1			Y	10/23/2006	10/25/2006	2	EEG normal 15.4, 13.2, 38, 348 Cardiology and neurology consults 86N/113/96 EEG pending CXR: normal chest  EKG normal Labs WNL with AST 45.	PVT	UNK		Congestion, no fever, no cough	2 previous episodes of seizures/cyanosis not requiring CPR			1						1	Convulsion; Cyanosis; Febrile convulsion; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U2243AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0265567	10/30/2006	NY	65.0	64		F		Cellulitis injection site.				Y					U	10/24/2006			NONE	UNK	UNK						1						1	Cellulitis; Injection site reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA216AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0265568	10/30/2006	NE	73.0	73		F		Redness in left arm over deltoid, swollen and warm, both vaccinations in same arm. Rocephin, Prednisone, Benadryl, Keflex.				Y					U	11/08/2005	11/08/2005	0	NONE	OTH	OTH	Effexor, Spironolactonel HCTZ, Tamoxifen, Vitamins.	NONE	UNK			1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0265569	10/30/2006	NE	11.0	10		M	05/10/2006	Right arm sore, red, hard to move, low grade fever, Benadryl, Then Claritin, Ibuprofen.				Y					U	11/14/2005	11/15/2005	1	NONE	OTH	OTH	NONE					1						1	Hypokinesia; Injection site erythema; Injection site pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0265570	10/30/2006	MI	70.0	69		F	10/25/2006	Arm feels heavy and hurts, chest, back, underarm, cant lift up arm.										10/24/2006	10/24/2006	0		UNK	UNK						1						1	Hypokinesia; Pain; Sensation of heaviness	FLU3~SANOFI PASTEUR~U2215AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265571	10/30/2006	TX	85.0	85		F	10/20/2006	Throat swollen, blood pressure increase, pt contacted doctor, was advised to take Benadryl.									Y	10/19/2006	10/19/2006	0		OTH	PVT	KCL, Premarin, HCTZ Propanolol.					1						1	Blood pressure increased; Throat tightness	FLU3~SANOFI PASTEUR~U2216AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265572	10/30/2006	AL	56.0	55		F	10/03/2006	Pt stated within 30 mins. of receiving flu vaccine she was on her way home when she experienced tightness in her chest. She also experienced throat tightness and was hoarse. She had wheals on her arms and neck, No treatment got better on its own by this morning, advised to see MD.									Y	10/02/2006	10/02/2006	0	NONE	PUB	UNK	Norvasc, Protonix, Toprol XL, Neurontin.		Heart disease, High blood pressure.		AL0626	1						1	Chest discomfort; Dysphonia; Throat tightness; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70737~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265573	10/30/2006	MD	4.0	4		M	10/25/2006	Left lat arm 8x11 cm erythema with 6x4 cm induration. non tender, increase local temp. on 10/25/06 exam reaction noticed 10/24/06 evening. Flu vaccine given IM left deltoid 10/23/06.				Y						10/23/2006	10/24/2006	1		PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site warmth	FLU3~SANOFI PASTEUR~02273AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265574	10/30/2006	ND	68.0	68		F	10/25/2006	Wide spread urticaria and pruritis.									U	10/24/2006	10/24/2006	0	NONE	OTH	OTH	Lipitor, Protonix, Multiple GTC supplements.		Hyperlipidemia, allergic rhinitis, GERD, Osteoarthritis.		ND0613	1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265575	10/30/2006	FL	67.0	67		M		10/06/2006 severe pain in right shoulder. 10/06/06 hospital ER. Given pain killer and told to see a physician. 10/09/2006 saw orthopedic Surgeon. Had W rays and MRI. 10/10/06 diagnosis deltoid hematoma from injection, acute rotator cuff tendonitis, septic arthritic from the injection. Given pain killer, antibiotics and rehab.				Y					N	10/06/2006	10/06/2006	0		PUB	OTH	Temazapam, Clonazepam, Carbidopa.	NONE	Allergies Polysporin, depression.			1						1	Arthritis bacterial; Injection site haemorrhage; Shoulder pain; Tendonitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0265576	10/30/2006	FL	40.0	40		F	10/25/2006	Approx 8-10 hours after receiving influenza vaccine, experienced pain in the shoulder, neck and severe headache.									Y	10/14/2006	10/14/2006	0		PVT	PVT		NONE	NONE			1						1	Headache; Neck pain; Shoulder pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA211A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0265578	10/30/2006	VT	7.0	6		M	10/25/2006	Lip/eye swelling following Fluzone.				Y					Y	10/17/2006				PVT	PUB	Claritin, Flonase		Allergic rhinitis, critical AS/aortic insufficiency			1						1	Eye oedema; Face oedema	FLU3~SANOFI PASTEUR~U2166AB~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265579	10/30/2006	VT	6.0	5		F	10/25/2006	Pt seen for Immunization administration. Returned to office 15 minutes later with swelling around eyes, 6cm diameter red, swelling, slight edema, around Varivax injection site, and few scattered urticarial lesions. Given Dexamethasone, Benadryl, Epi on hand. PT watches about 4 hours office released home.				Y					Y	10/24/2006	10/24/2006	0	PT to f/u with allergy specialist and lab testing.	PVT	PUB	Albuterol, Nasonex, Ditrol LA					1						1	Erythema; Eye oedema; Injection site oedema; Injection site reaction; Skin ulcer; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71210~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARCEL~MERCK & CO. INC.~1048F~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0265580	10/30/2006	PA	1.19	1	.2	F	10/25/2006	On 10/06/06 or 10/07/06 mom noted several vesicular lesions on left thigh surrounded by erythema at injection site, increased swelling x 3-4 D, then decreased, slight tender, No fever no rash elsewhere. MD saw 10/11/06 left lower thigh with about 2cm area erythema, slight induration with overlying crusting vesicle. Non tender, Excoriated, no rash elsewhere, no evid. cellulitis/abscess. Sx TX.									Y	09/26/2006	10/06/2006	10	Pt seen by MD 10/11/06	PVT	PVT						1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site vesicles; Skin ulcer; Tenderness	FLU3~SANOFI PASTEUR~U2178AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE919AA~4~IM~LL~HIB (ACTHIB)~1|MMRV~MERCK & CO. INC.~0826F~1~SC~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0265581	10/30/2006	GA	32.0	32		F	10/25/2006	Pt returns to office c/o itching all over. Pt state approx 30 min after receiving flu vaccine began to itch from head to feet, soles of feet even itching. No SOB, no swelling, no vesicle rash. Pt states previous hx flu vaccine with no adverse reaction (approx 10 years ago). Pt has no egg allergy, no history any drug allergy. Claritin XL given with relief of itching.									Y	10/25/2006	10/25/2006	0	NONE	OTH	OTH	NONE	NONE	Hypertension			1						1	Pruritus	FLU3~SANOFI PASTEUR~2275AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265582	10/30/2006	ID	23.0	22		F	10/26/2006	Red area with slight warmth around injection site, Painful to touch.									Y	10/25/2006				PVT	PVT		NONE	NONE			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA208BA~1~SC~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0265583	10/30/2006	MI	25.0	24		F	10/14/2006	Immediately dizzy, diaphoretic, cold, clammy, blurred vision, pale, BP 60/86, pulse thready, Epi 0.5 given per RN, pulse better 86. Receipts and all information regarding Flu shot given to pt before transport to ER, Police arrive, then EMS arrived took to ER alert, orientated and feeling better. Cold pack followed and appropriate at time of administration of vaccine.				Y					Y	10/14/2006	10/14/2006	0	NONE	UNK	OTH	UNK					1						1	Blood pressure decreased; Cold sweat; Dizziness; Feeling cold; Heart rate irregular; Hyperhidrosis; Pallor; Vision blurred	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71215~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0265584	10/30/2006	NJ	34.0	34		M	10/24/2006	Immediate severe pain associated with pneumococcal vaccine redness, swelling, hive on the medial aspect of the injection site.				Y					Y	10/18/2006	10/18/2006	0	NONE	PVT	PVT	NONE	NONE	HIV			1						1	Injection site erythema; Injection site oedema; Injection site pain; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~7737~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0320F~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0265601	10/30/2006	NC	67.0	67		F	10/30/2006	Arthus reaction manifested by local erythema and edema to just above the elbow that slowly improved over the following 6 days.										10/24/2006	10/24/2006	0	NONE	MIL	MIL		None; h/o breast cancer, s/p left breast mastectomy				1						1	Erythema; Oedema; Type III immune complex mediated reaction	FLU3~SANOFI PASTEUR~U2199AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1210R~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265602	10/30/2006	MD	62.0	62		F	10/30/2006	10/26/06 - 11pm started to feel achy. 10/27/06 - R arm hurting, edema from elbow to axilla. Arm red/hot to touch. Fever 101. 10/27/06- Seen at clinic; Rx Augmentin given. 10/30/06 - Edema resloved, no temperature.				Y					Y	10/26/2006	10/26/2006	0	None	UNK	UNK	unknown	NO	None			1						1	Erythema; Injection site warmth; Oedema; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2178AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0607R~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0265606	10/30/2006	SD	40.0	40		F	10/30/2006	Employee complained of redness, swelling, warmth and discomfort around injection site.  Area red, warm to touch and uncomfortable to touch on exam.									Y	10/27/2006	10/28/2006	1		UNK	UNK			NKA	Local Skin Reaction~Influenza (Seasonal) (Fluarix)~1~0.00~In Patient		1						1	Discomfort; Injection site erythema; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA213BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0265607	10/30/2006	IA	80.0	80		F	10/30/2006	RECEIVED VACCINE ABOUT NOON ON 10-19-06. THAT EVENING SHE NOTICE RASH ALL OVER BODY. NOT RAISED OR IRRITATING. THE RASH WAS MOSTLY GONE BY MORNING BUT PERSISTED IN THE RT LOWER LIMB FOR 2 DAYS. MODERATE ACHES AND PAINS THROUGHOUT ENTIRE BODY FOR 2 DAYS AFTER VACCINATION. PT HAS RECEIVED THE INFLUENZA VACCINE BEFORE WITHOUT ANY PROBLEMS LIKE THIS IN THE PAST.									Y	10/19/2006	10/19/2006	0		UNK	UNK	BISOPROLOL,AMBIEN,LEVOTHYROXINE,ACTONEL,AROMASIN,INDAPAMIDE,LIPITOR,KCL	NO	CANCER WITH CHEMOTHERAPY, OSTEOPOROSIS HYPOTHYROID,			1						1	Pain; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F600911~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0265608	10/30/2006	MI	42.0	42		F	10/30/2006	Approximately 1 hour after administration, dry, choking like cough developed.  7 hours after administration, patient developed a fever(101.5), dizziness, mood changes, racing heart-rate, weakness and odd breathing - felt like something in my chest.  Experineced no hives. No treatment sought.  Following day had fever and body aches.  Third day had only a low grade fever (99).  Felt fine on the fourth day.									Y	10/27/2006	10/27/2006	0	None	UNK	UNK	None	None	None			1						1	Asthenia; Cough; Dizziness; Dyspnoea; Heart rate increased; Mood altered; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2244AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265611	10/30/2006	MD	21.0	21		F	10/30/2006	After Flumist vaccination, pt developed low grade fever x 3 weeks, swollen lymph nodes x 1 week, developed congestion and cough x 3 weeks and headaches.  Patient had nausea and vomiting x 1 week. Pt missed total of about 6 days of work.				Y					Y	09/13/2006	09/16/2006	3		MIL	MIL	Nuvaring, Midrin, women's one-a-day multi-vitamin	No illness at time of vaccination	NKDA, season allergies			1						1	Cough; Headache; Lymphadenopathy; Nasal congestion; Nausea; Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500436P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0265612	10/30/2006	GA	69.0	69		F	10/30/2006	Pt assessed due to complaint of arm pain s/p injection antibiotics started.				Y					Y	10/25/2006	10/26/2006	1	CBC done, within therapeutic range.	UNK	UNK	Allopurinol  Aspirin  Buspar  Caduet  Celebrex  Glucophage  Zebeta Zoloft					1						1	Pain	FLU3~SANOFI PASTEUR~U2243aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0485f~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0265615	10/30/2006	IL	67.0	67		M	10/30/2006	Right arm sore and feel rotten all over.  Evening of 10/19/06 arm really hurting.  Feels better today; but thought you ought to know about it.  Applied heat to it Client applied heat to it.  Took tylenol.									Y	10/19/2006	10/19/2006	0		UNK	UNK	Unknown	Unknown	Unknown			1						1	Malaise; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F600911~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0618~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265616	10/30/2006	IL	64.0	64		F	10/30/2006	The day after receiving the flu shot, patient states she developed sudden onset of diarrhea, shorly after joint pain in shoulders, knees, ankles and arches of feet.  No pain in hips or elbows.  Also had trouble swallowing for few hours, resolved now.  C/O significant swelling in hands, unable to make fist.  Joint pain and swelling still persist today.									N	10/28/2006	10/29/2006	1	None	PUB	PUB	Synthroid	None	Allergy to Codiene			1						1	Arthralgia; Diarrhoea; Dysphagia; Musculoskeletal pain; Oedema peripheral	FLU3~SANOFI PASTEUR~U2243AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265618	10/30/2006	UT	12.0	12		M	10/30/2006	He received the shot in an afternoon clinic and that night he woke up around 1:30 am screaming and holding his head.  He was saying everything is spinning, I don't know what is wrong.  Called 911 and they came and evaluated client.  Mom took temperature and the temp was 103.  EMS evaluated client and did not find anything.  October 10th client developed a cold and then went and was put on amoxicillin.  Rash started on his face a week after that and rash has spread on his face.  Rash is only on the right side of his face.  Finished the course of amoxicillin.  Has appointment with dermatologist on Thursday.				Y					Y	10/03/2006	10/04/2006	1		UNK	UNK	None	None	Legg-Perthes disease			1						1	High-pitched crying; Pharyngitis; Pyrexia; Rash; Rhinitis; Vertigo	FLU3~SANOFI PASTEUR~U2240AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1875AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0265619	10/30/2006	WI	5.0	5		M	10/30/2006	WOKE WITH T.100 ON 10/27/2006.LETHARGIC ALL DAY. T. WENT AS HIGH AS 101.5. THAT NIGHT MOM NOTICED AN AREA ON HER LEFT ARM WHICH WAS RED, HOT AND RAISED, ABOUT THE SIZE OF A TENNIS BALL. NO ITCHING. ARM WAS SOMEWHAT SORE WHEN SHE LIFTED IT.									Y	10/26/2006	10/27/2006	1		UNK	UNK						1						1	Erythema; Injection site warmth; Lethargy; Pain; Pyrexia; Rash erythematous	FLU3~SANOFI PASTEUR~U2212AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1043F~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0265622	10/30/2006	ND	0.0	32		F	10/30/2006	RASH AROUND INJECTION SITE, APPROX. 2 TO 3IN LASTING 4 DAYS. RASH ON CHEST ON 3RD DAY (LASTING ONLY ABOUT 8 HRS),  HEADACHES AND VERY SORE THROAT CONTINUING, DIZZYNESS (3RD DAY), MUSCLE ACHES IN INJECTION ARM CONTINUING. VERY TIRED, LIKE FIGHTING OFF A COLD									Y	10/19/2006	10/19/2006	0	NONE	UNK	UNK		NONE	ALLERGIC TO PENICILLIAN, AMOXICILLIAN, SULFA DRUGS, LATEX	SEVER SWELLING AND REDNESS FROM ELBOW TO SHOULDER, LARGE WHITE/HARD SPOT 6IN DIAMETER FOR 3 WEEKS AFTER.~Measles + Mumps + Rubel		1						1	Dizziness; Fatigue; Headache; Injection site rash; Myalgia; Pharyngolaryngeal pain; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0265635	10/30/2006	PA	12.0	11		M	10/27/2006	large (3x2  1/4 inch) warm, red, slightly raised local reaction on right upper arm.									Y	10/25/2006	10/26/2006	1	NONE	PVT	PVT	Flonase, Pulmicort, Allegra		Asthma, allergies, GE reflux.			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2273AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1044F~2~IM~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0265636	10/30/2006	TX				F	10/30/2006	Hot, swollen, and red at the injection site. No other symptoms, no open sore or drainage.									Y	10/12/2006	10/13/2006	1	NONE	PVT	PVT		NONE	Cancer of breast, breast surgery.			1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U2212AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265637	10/30/2006	NY	48.0	47		F	10/30/2006	Generalized rash, urticaria, employee denied any allergies until reaction occurred she stated she had cortisone the same day as her flu vaccine 2 yrs ago and was told by her MD rash was due to cortisone.									Y	10/30/2006	10/30/2006	0		PVT	UNK		NONE	NONE	rash~Influenza (Seasonal) (Fluzone)~~45.00~In Patient		1						1	Rash; Urticaria; Vaccine positive rechallenge	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA213AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0265638	10/30/2006	CT	83.0	83		F	10/23/2006	Left arm has marked area of erythema (10x12cm), warm to touch and is bordered by 2 area of ecchymosis (approx 2x4cm) pt is not on anti coagulants.									Y	10/21/2006	10/22/2006	1		PUB	PUB	Lipitor, Altase, Glyburide		High blood pressure, High Cholesterol, Diabetes.			1						1	Injection site erythema; Injection site haemorrhage; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70383~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265623	10/31/2006	CO	52.0	52		F	10/30/2006	I received two vaccines: influenza and pneumococcal at my work place. At the site of the pneumococcal polysaccharide vaccine injection (outside left upper arm half-way between shoulder and elbow), there was redness that spread to a diameter of 3 inches with swelling, and pain to the touch approximately 30 hours after injection. I also experienced chills, weakness, and dizziness at this time. 48 hours later, the redness at the pneumococcal polysaccharide injection site is now wider and larger, and I can barely move my arm. I became extremely weak, I experienced exhaustion after completing a simple task, and at moments of relaxation I could feel my heart beating at a rapid heart rate. Also, I was still experiencing dizziness and chills. At this time, I had a low-grade fever of 99.1, and my average temperature tends to be 97.6 degrees. On October 22 at approximately 11:15 AM, I called and spoke to a nurse practioner, who said to put antibiotic ointment and a warm compress at the site of the pneumococcal polysaccharide injection, and to take an anti-inflammatory. The nurse practioner said if I become worse, to call my doctor. I followed the nurse practioner instructions. By the next day, Monday, the redness grew to 3.5 x 5 inches with a large hard lump almost as big and was still very painful. Although, I was not experiencing the dizziness, I became exhausted easily. I called my doctor's office, and made an appointment for that afternoon. Dr. processed lab work on my blood and urine and ran an EKG. He sent me home with 5 tablets of Zyrtec 10 mg, and allergy medication. I was instructed to take one tablet at night for 5 days. I had lost 2 pounds in 3 days - down to 118 lbs, and I'm 5'5. On Tuesday, I reported to my doctor's office that I was stil weak and now had a sore throat in the morning. Within 48 hours of taking the Zyrtec 10 mg, the redness and lump receded by at least an inch all around. However, it was on this day, Wednesday, October 25, when I learned that the only other co-worker that received a pneumococcal polysaccharide vaccine had a similar experience at her pneumococcal polysaccharide vaccine injection site, except her experience was worse than mine.I was told to ice the pneumococcal polysaccharide vaccine injection site. She was taken to the emergency room the evening of October 20, 2006, as her redness and swelling was past her shoulder joint and her elbow joint. My co-workers diagnosis was Cellulitis. I reported to my doctor this news. He said if I did not get better from his current instructions, then he would see about changing them. On Saturday, October 28, my sore throat became constant throughout the day, and worse at night. I have now post nasal drip, sneezing, slightly congestion in my nasal passages, and tight chest - I suspect wheezing. The injection site is now 2 x 2, though not a bright red anymore - just a dark shadow appearance - and a hard lump that hurts when pressed. I would appreciate any feedback regarding this matter.				Y					N	10/19/2006	10/20/2006	1	Diagnosis: allergic reation to pneumococcal polysacchride vaccine.  Tests: urine and blood lab work and an EKG.	UNK	UNK	Hormone Replacement Therapy - Half tablet of each at night: Tri-Est 2/.25/.25 Progesterone 100mg VANIQA prescription cream applied twice daily morning and night for 30 days.		Allergy to codine and the penicillin family.			1						1	Asthenia; Cellulitis; Chills; Dizziness; Fatigue; Heart rate increased; Hypersensitivity; Injection site erythema; Injection site induration; Injection site mass; Injection site pain; Injection site reaction; Injection site swelling; Pharyngolaryngeal pain; Postnasal drip; Pyrexia; Weight decreased; Wheezing	FLUX~UNKNOWN MANUFACTURER~~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0265633	10/31/2006	GA	30.0	30		F	10/30/2006	Sat evening past vaccines pt c/o burning sensation on internal parts of body, felt confused. Pt last seen Mon am 3 and found at 5pm ER Intubated, hypothermia, T 89 core, no B/P, to ICU x 3 days 3 days of floor.  11/10/06 Received only partial medical records requested from hospital.  T/C to hospital to request remainder of records.  Available records reveal patient admitted 10/23/06.  Was found unresponsive & unclothed in her bed by parent.  Last seen several hours prior.  EMS found her w/agonal respiration & O2sat of 73%, hypotensive, glucose 102, initial rectal temp 87.8.  Intubated in ER & given aggressive fluids. Admit DX: hypotension & shock of unclear etiology; altered mental status; profound hypothermia; anion gap metabolic acidosis most likely lactic acidosis; respiratory failure; elevated creatinine; mild leukocytosis; significantly elevated CPK most likely due to rhabdomyolysis; mily hypernatremia; hx of thyroid cancer; chronic back pain; hx of partial seizure disorder; bipolar disorder; PCOD; and obstructive sleep apnea.  Admitted to ICU & put on multiple antibiotics after cultured.   2/16/07 Received medical records from hospital which reveal patient d/c to home on 10/28 on inhaler, KCL supplement & continued oral antibiotics. FINAL DX: altered mental status w/acute respiratory failure with respiratory acidosis, metabolic acidosis, resolved, etiology uncertain; fever, probable aspiration pneumonia, improved; fatty liver w/elevated LFTs; rhabdomyolysis, resolved; mild hypokalemia; hx of bipolar dx; polycystic ovarian disease; partial seizures; chronic pain syndrome.			Y	Y	Y	6			U	10/21/2006	10/21/2006	0	LABS: WBC 11,300, CPK 3,260; urine screen + for benzodiazepine, opiates & cannabinoids (uses marijuana for chronic pain control).  CT of head WNL.  EKG showed nonspecific ST-T wave changes; CXR showed cardiomegaly w/bilateral fluffy interstitial infiltrates.	OTH	OTH	Depakate, Zoloft, Zelnorm, Levothyroxine, Aldactane, Lunesta, Oxycodone, Flexeril, marijuana.		SOMA, Follicular Thyroid Ca, previous HX of seizure.  PMH: follicular thyroid cancer 2003 s/p total thyroidectomy; seizure disorder s/p MVA w/CHI 1998; bipolar disease 2002; polycystic ovarian disease; high cholesterol; sleep apnea; chronic back pain & right arm pain s/p work injury several years prior; & obesity.			1						1	Blood pressure decreased; Body temperature decreased; Confusional state; Feeling hot; Hypothermia	FLU3~SANOFI PASTEUR~U2245AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0486F~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0265634	10/31/2006	PA	77.0	76		F	10/27/2006	Flu vaccine given on 10/149/06 left deltoid IM. In the evening on 10/20/06 noticed redness, swelling, itch and warmth over entire left upper arm. Applied ice for 24 ours and SX improved. On Sat noticed bilateral lower leg and feet red and itchy. On Monday right hand and elbow became itchy. Applied hydrocortisone cream with relief. Pt also on Zyrtec 10mg for TX of year round allergies.				Y					U	10/19/2006	10/20/2006	1		PVT	PVT	Sudafed	Eustachian tube dysfunction.				1						1	Erythema; Injection site erythema; Injection site hypersensitivity; Injection site oedema; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U2195AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265670	10/31/2006	UT	56.0	56		F		Difficulty breathing, Hoarseness, Dizziness, Weakness, rapid heart beat.									N	10/20/2006	10/20/2006	0		OTH	UNK	NONE					1						1	Asthenia; Dizziness; Dysphonia; Dyspnoea; Heart rate increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0265671	10/31/2006	SC	4.0	4		F	10/31/2006	2in X 1 1/2 in red, firm, warm area at injection site right leg.									U	10/27/2006	10/28/2006	1		PVT	PUB						1						1	Injection site erythema; Injection site induration; Injection site warmth	FLU3~SANOFI PASTEUR~U2244AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~0817F~UNK~~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0265673	10/31/2006	NH	47.0			F		Shingles outbreak symptoms 2d prior, rash the day after.									Y					OTH	PVT		Pain tenderness at site the day before vaccination.	NONE			1						1	Herpes zoster; Rash; Viral infection	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0265674	10/31/2006	TX	44.0			U		Arm Swollen and rash of about 4 1/2 inches in area. Painful and swollen. Pt was going to go see his regular Dr.														OTH	PVT	NONE	NONE	NONE			1						1	Injection site oedema; Injection site pain; Injection site rash	FLU3~SANOFI PASTEUR~U2213AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0619F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265675	10/31/2006	PR	39.0	39		M		Sleep problems, skin itching dry and flaky, Impotence, Incontinence urinary, memory difficulty, headaches continuos.									N	01/23/2003	06/24/2004	518	Cholesterol; Migraine; MRI and CT scan of head; HBP; Erectile Dysfunction.	MIL	MIL		None	None			1						1	Blood cholesterol; Computerised tomogram head; Dry skin; Erectile dysfunction; Headache; Hypertension; Memory impairment; Nuclear magnetic resonance imaging; Pruritus; Pruritus; Skin disorder; Skin exfoliation; Sleep disorder; Urinary incontinence	ANTH~UNKNOWN MANUFACTURER~~UNK~IM~~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0265677	10/31/2006	NJ	4.0	4		M	10/30/2006	Swollen, redness of right arm tense below vaccine site.									Y	10/23/2006	10/26/2006	3		PVT	PUB						1						1	Injection site erythema; Injection site oedema	DTAP~SANOFI PASTEUR~U1397BA~5~~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2275AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265678	10/31/2006	CT	17.0	17		M	10/30/2006	Chest pain, itching, hive, TX Prednisone 10mg, Albuterol inhaler 2 Puffs.				Y					U	10/24/2006	10/27/2006	3	EKG, Chest X ray	PVT	PVT	NONE	NONE	Allergies, sulfa, Augmentin.		CT200608	1						1	Chest pain; Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70618~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0265681	10/31/2006	VA	39.0	38		F	10/30/2006	Sensation of swelling in neck and left deltoid area, tingling and sharp pain in left foot. Tingling in right hand. Referred to neurologist today.				Y					U	10/25/2006	10/25/2006	0		PVT	UNK			Recovering from bronchitis.			1						1	Injection site oedema; Oedema; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U2189AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265682	10/31/2006	CO	48.0	48		F	10/31/2006	Pt given injection in the superior anterior portion of right deltoid. Pt heard crunching sound. Pain has gradually worsened.									N	10/22/2006	10/22/2006	0		OTH	PVT		No	Seasonal allergies, GERD, Migraines.			1						1	Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~AR~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0265684	10/31/2006	IN	30.0	30		F	10/31/2006	HIVES & ITCHING OVER ENTIRE BODY.  STARTED FRIDAY, 10-17-06 @ 11 PM.  CALLED PHYSICIAN ON SUNDAY.  PHYSICIAN DETERMINED THAT IT WAS A REACTION TO THE INFLUENZA VACCINATION.  PATIENT WAS GIVEN A PRESCRIPTION FOR A 10 DAY REGIME OF PREDNISONE.  THE WELTS FELT WARM, BUT THERE WAS NO GENERALIZED FEVER.									Y	10/27/2006	10/27/2006	0	NONE	UNK	UNK	WELBUTRIN, NEXIUM, WATER PILL	NONE	MENIERE'S DISEASE, ACID REFLEX, DEPRESSION			1						1	Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70737~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265685	10/31/2006	VA	42.0	42		F	10/31/2006	10/27/06 sudden onset of severe dizziness, nausea, headache, heartburn, muscle weakness UE and LE. Admitted to hospital X 2 nights for w/u12/08/06 Received medical records from hospital reveal patient experienced dizziness, spinning sensation, heartburn, nausea, right ear pain, headache, slurred speech & heaviness of arms & legs. Admitted to hospital on 10/27/06. Consults by ENT, neuro which revealed nystagmus even in primary position of gaze & tympanic membrane changes right ear.  Improved with treatment of antibiotics, antinausea & anti vertigo meds.  D/C to home on 10/29/06.   Final Dx: Vertigo & sinusitis, both improving.  Per annual follow up report: Permant damage to right inner ear. Per 60 day follow up: She has recovered fro the most part and returned to work approx 1 month ago. She continues to have mild balance problems.					Y	2			Y	10/12/2006	10/27/2006	15	LABS: WBC on admit 11.1.  CT of head was WNL. MRI brain WNL.  MRA of brain & neck revealed congenital anomalies.	UNK	UNK		none	none known PMH: hyperlipidemia, GERD.			1						1	Balance disorder; Computerised tomogram normal; Dizziness; Dysarthria; Dyspepsia; Ear pain; Headache; Impaired work ability; Muscular weakness; Nausea; Nuclear magnetic resonance imaging brain abnormal; Nuclear magnetic resonance imaging brain normal; Nystagmus; Sensation of heaviness; Sinusitis; Vertigo; White blood cell count increased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA221BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0265686	10/31/2006	NY	72.0	72		M	10/31/2006	On 10/21/2006, at 11:30am, received his flu shot.  At 3:00pm he states that he began to feel cold, chills, sweats, vomiting, dizzy, and weak.  He states that this continued until 9:00pm, and he then began to feel better, but still tired and weak.  Stated that he stayed in bed and rested, with out symptoms, until 10/23/2006, 7:00am, and stated that he then felt normal.  He states that he did not call or see a doctor during this time.  States that he believes that it is due to the flu shot, as he had the flu shot two years ago and had a similar reaction.  States that he will be discussing this with his MD, and will not get another flu shot.  States that he did not get the flu shot last year.									Y	10/21/2006	10/21/2006	0	None.	UNK	UNK	Flecainide 100mg, 2 tablets, BID Insulin SQ, BID Lotrel 5/10, 1 capsul QDay Metoprolol 60mg BID	Denies.	NKA Diabetes Mellitus Hypertension Lower aorta aneurism repair with stent.	chills, N/V, dizzy~Influenza (Seasonal) (no brand name)~1~0.00~In Patient		1						1	Asthenia; Chills; Dizziness; Fatigue; Feeling cold; Hyperhidrosis; Similar reaction on previous exposure to drug; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F600911~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0265688	10/31/2006	GA	0.2	0	.2	F	10/31/2006	NO ADVERSE REACTIONS HAVE BEEN OBSERVED AT THIS POINT.  INFLUENZA SHOT ADMINISTERED TO INFANT LESS THAN 6 MONTHS OF AGE.										10/27/2006			NONE	MIL	MIL	NONE	NONE	NONE			1						1	Medication error	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B089AA~1~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2174GA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0276F~1~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08646H~1~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0847F~1~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0265689	10/31/2006	MA	1.54	1	.5	M	10/31/2006	Onset of swelling in r upper arm extending to 50% of right upper limb within 24 hours of immunization, associated fever. After 24 hours developed blisters in same area. Seen in Emergency room. Treated with Prednisone, Benadryl and antibiotics with improvement.				Y					Y	10/27/2006	10/28/2006	1	none	UNK	UNK		none	none			1						1	Injection site vesicles; Pyrexia; Swelling	DTAP~SANOFI PASTEUR~U1857CC3108~4~IM~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2174EA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265690	10/31/2006	CT	77.0	77		M	10/31/2006	On awakening the following morning client reported having chills, nausea, dizziness, fever and his bones felt sore. He went to hospital emergency room were he said his temperature was recorded at 103F and he said the doctor told him it was a reaction to the flu vaccine. He was given IV fluids and antibiotics and told to take Motrin or Tylenol for fever and report to own doctor if he did not feel better.				Y					Y	10/27/2006	10/28/2006	1	Unknown	UNK	UNK		None client stated he felt well	No allergy to eggs or Thimersol. NKA			1						1	Bone pain; Chills; Dizziness; Nausea; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71355~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0265691	10/31/2006	NM	47.0	47		F	10/31/2006	A 4cm area, raised with induration. swelling traveled down arm to elbow to length of 15 cm. hot to the touch and tender. No drainage noted. Area of arm affected is front upper arm from site of injection to elbow. Assumed to be the pneumococcal vaccine injection. Pt further states that sx started with mild flu like symptoms: ha, fever, body aches, chills, and got progressively worse as day progressed.									U	10/27/2006	10/28/2006	1		UNK	UNK						1						1	Chills; Headache; Injection site induration; Injection site pain; Injection site swelling; Injection site warmth; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71639~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0674f~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~u1923ga~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0265692	10/31/2006	CO	90.0	90		F	10/31/2006	The patient complained of pain in the right arm which progressed to her neck and back. She also reported a loss of hearing in both ears for approximately one hour. However, the patient does wear hearing aids in both ears. The patient reports to us 8 days after receiving the vaccine and everything is resolved with no current complaints. She states that she feels completely fine now.									Y	10/23/2006	10/23/2006	0		UNK	UNK	None	None	None			1						1	Back pain; Hearing impaired; Neck pain; Pain	FLU3~SANOFI PASTEUR~U2218AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265693	10/31/2006	TN	26.0	26		F	10/31/2006	Influenza Vaccine given around noon on 10/30/06.  No allergy to eggs or eggs products.  This was her 1st flu vaccine.  Symptoms began around 1455.  Presented to the E.D. at 1740 with Tachycardia, eye redness, and itchy sore throat.  Solu Medrol 100mg. IV and Benadryl 25mg. IV.  Breathing treatment X1.  Observed until 0200 on 10/31/06, then discharged.				Y					Y	10/30/2006	10/30/2006	0	DX: Oculorespiratory Syndrome	UNK	UNK	Birth Control Pills	None	None			1						1	Ocular hyperaemia; Pharyngolaryngeal pain; Tachycardia	FLU3~SANOFI PASTEUR~U2212AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265694	10/31/2006	CO	29.0	29		M	10/31/2006	Hives and rash broke out over thighs and torso.  Also, I experienced muscle fatigue and aches.									Y	10/13/2006	10/14/2006	1		MIL	MIL		None				1						1	Muscular weakness; Myalgia; Rash; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500431P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0265697	10/31/2006	GA	3.0	3		M	10/31/2006	Patient presented 7 days after vaccination with left sided Bell's palsy. Referred to neurology after being placed on oral steroids. Left face flaccid, DX Bell's Palsey. Neuro referral provided. 11/17/06-continues with normal sensation. Slight decrease ton of Left?Right with 4/5 strength. DX: bell's Palsy, fever, pharnygitis-strep, URI.									U	10/23/2006	10/29/2006	6		UNK	UNK	None	None	None			1						1	Facial palsy; Pharyngitis; Pyrexia; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~U216CA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265702	10/31/2006	PA	36.0	36		F	10/31/2006	I RECEIVED THE FLU VACINATION AND A PNUEMONIA VACINCATION IN THE LEFT SHOULDER AT THE SAME TIME. AROUND 1:30PM ON 10/27/06. ABOUT 2 HOURS AFTER THE SHOTS MY ARM BECAME INCREASINGLY SORE.  THE SORENESS STARTED IN THE SHOULDER BUT OVER THE COURSE OF THE EVENING SPREAD TO THE ENTIRE LEFT ARM, ARMPIT, LEFT SIDE OF TORSO AND LEFT SIDE OF NECK UP TO BELOW THE LEFT EAR. I HAD LOW FEVER ON THE EVENING OF THE SHOT AND THE FOLLOWING MORNING AND NAUSEA (HOWEVER NO VOMITING).  I HAVE NOT HAD MUCH OF AN APPETITE FOR THE LAST 3 DAYS BUT THE OTHER SYMTOMS HAVE IMPROVED. SHOTS WERE GIVEN BY VISITING NURSES - PAID FOR BY MY EMPLOYER.									Y	10/27/2006	10/27/2006	0		UNK	UNK	SYNTHROID	NO	HYPOTHYROIDISM			1						1	Decreased appetite; Nausea; Neck pain; Pain; Pyrexia; Shoulder pain; Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265703	10/31/2006	PA	10.0	10		F	10/31/2006	Headache after administration of Flu Mist (nasal flu vaccine)- occurred immediately after vaccination. Tylenol given. Resolved within 24 hours.									Y	10/30/2006				UNK	UNK		None	Failure to thrive Elevated LFT's- no etiology			1						1	Headache	FLUN3~MEDIMMUNE VACCINES, INC.~50043P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0265704	10/31/2006	TX	66.0	66		F	10/31/2006	Within 20 minutes of receiving vaccine, felt itching and redness with warmth to site of vaccination, left deltoid.									Y	10/31/2006	10/31/2006	0	vital signs: T 98.2 F, BP 140/78, P 84 regular; PE: speech clear, no distress, no eyelid or lip swelling	UNK	UNK			penicillin			1						1	Injection site erythema; Injection site warmth; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71926~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265705	10/31/2006	MN	31.0	31		F	10/31/2006	Sore throat on 10/19 in the AM - no treatment. Headache and neck pain starting on 10/21. Severe headache, neck pain, and fever on 10/22.  Went to doctor on 10/22.  Doctor sent patient to ER.  CT scan, blood work, and lumbar puncture done in ER.  Given MS 6 mg, Zofran 4 mg X 2, Phenergan 25 mg, 2 gm Rocephin; all IV. Headache and neck pain continued for next 3 days.  CBC done on 10/26.  Patient returned to ER because of severe head ache. Blood patch to lumbar puncture site was done on 10/26 to correct leaking spinal fluid from lumbar puncture.  Patient's headache was still present but pain was much less.  Patient said symptoms subsided completely on 10/29.				Y					Y	10/17/2006	10/19/2006	2	10/24/2006 CBC done 10/24/2006 Normal enhanced head CT 10/24/2006 Lumbar puncture - neg for meningitis and RBCs 10/26/06 Normal CBC	UNK	UNK	Ortho Evra	None	None			1						1	Headache; Neck pain; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500434P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0265706	10/31/2006	PA	65.0	65		F	10/31/2006	Developed chills PM of 10-26-06. Headache for 24 hours starting 10-28-06. Decreased appetite. 10-28-06 patient noted a 4X4 inch red swollen area right upper arm at injection site. 10-31-06 patient states she is feeling better. Still with small amount of redness and swelling at injection site.									Y	10/26/2006	10/26/2006	0	None	UNK	UNK	No Meds	None known	None			1						1	Chills; Decreased appetite; Headache; Injection site erythema; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69480~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0620F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265707	10/31/2006	TX	1.1	1	.1	M	10/31/2006	Pts mom states that child has fluid filled blisters appearing all over body. Confirmed by hospital staff. Started 10/30/06.				Y					U	10/27/2006	10/30/2006	3		UNK	UNK		None	colic-11/05, congestion-11/05, allergic dermititis-04/05, ge reflux-11/05			1						1	Blister	FLU3~SANOFI PASTEUR~u2192aa~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~0823f~1~SC~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~b08682d~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0265708	10/31/2006	IN	16.0	15		M	10/31/2006	Pt. and mom returned to clinic on 10-31-06 at approx. 6:50pm and reported hives starling on upperback and chest them spreading to trunk and down arms and legs on Sat., 10-28-06 and swollen eyes on Sun, 10-29-06. Denies SOB, Denies redness or swelling at L deltoid injection site. Mother says hives resolved with Benadryl No redness or swelling observed at L deltoid by NP.									Y	10/27/2006	10/28/2006	1	none	UNK	UNK	Advair, doxycycline, albuterol, singulair	none reported	asthma pt mother			1						1	Eye swelling; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70738~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265709	10/31/2006	FL	2.0	2	.6	F	10/31/2006	Started showing signs of hives, ichy rash all over body (legs, arms, buttocks, face, shoulders, and back) approx 15-20 minutes after administration of flu doseage. Returned to the doctors immediately and was told to administer 1 tsp of Children's Bendryl every 4-6 hours until symtoms were relieved.				Y					U	10/31/2006	10/31/2006	0		UNK	UNK	none	cold-cough, stuffy nose, and sneezing	none			1						1	Pruritus; Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0265714	10/31/2006	VA	6.0	6		M	10/31/2006	Hives, rash, wheezing, chest pain, SOB.			Y	Y					Y	10/31/2006	10/31/2006	0		PVT	PUB	Xopenex, Pulmicort.	Coughing, no fever, history asthma	Chronic RAD			1						1	Chest pain; Dyspnoea; Rash; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U2275AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0265715	10/31/2006	DC	35.0	35		M	10/31/2006	Developed total body rash with itching 4 hours after receiving FluMist. Case complicated by a 3 week viral illness that had just resolved and pt had taken Levaquin for 3 days and stopped the medication 2- days before receiving the vaccine. Dermatitis, Diffuse, generalized.									Y	10/17/2006	10/18/2006	1	CMG IGM neg, EBV IGM neg, LYM AB neg, RBC blood 4.09 (L), HgB blood 12.1 (L), HCT blood 34.9 (L), MCV blood 85.3, MCH blood 29.6, MCHC blood 34.7, Pit Blood 431 (H), RDW CV blood 11.7 (L), MPV Blood 6.9 (L).	MIL	MIL	NONE	Lymphadenopathy resolving. Stopped Levaquin 2-3 days before receiving FluMist.	NONE			1						1	Dermatitis; Haematocrit decreased; Haemoglobin decreased; Laboratory test abnormal; Platelet count decreased; Rash pruritic; Red blood cell count decreased	FLUN3~MEDIMMUNE VACCINES, INC.~500430P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0265716	10/31/2006	MD	7.0	7		F	10/26/2006	12:15 c/o red, raised rash with hives right forearm, small red area left arm, 4pm back of right hand red rash, per mom saw Dr pm 10/26/06, spoke to mom 10/27/06 reports Dr above symptoms were related to a local reaction from something other the FluMist, rash gone next day after Benadryl, Child in school.				Y					Y	10/26/2006	10/26/2006	0		UNK	PUB	NONE	NONE	Eczema, Previous rash to orange peel, chlorine, polyester			1						1	Erythema; Rash; Rash erythematous; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500438P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0265719	10/31/2006	FL	1.26	1	.3	F	10/31/2006	Broke out in rash within 24 hours of receiving vaccines, rash on trunk and face.				Y						10/30/2006	10/31/2006	1	NONE	PVT	PVT		NONE	NONE			1						1	Rash	DTAP~SANOFI PASTEUR~C2489AA~4~~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2166BA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF026AA~4~~LL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0699F~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0265720	10/31/2006	PA	51.0	51		F	10/30/2006	Fever 104 degree within 8 hours of receiving shot.									Y	10/25/2006	10/26/2006	1	NONE	PVT	PVT	NONE	cough for 3 weeks, without fever	migraine headache, anxiety			1						1	Pyrexia	FLU3~SANOFI PASTEUR~U2195AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265722	10/31/2006	NY	0.57	0	.6	F	10/27/2006	1/2 dollar size red area on both left and right thighs.									Y	10/26/2006	10/27/2006	1	NONE	PVT	PVT		NONE	NONE			1						1	Erythema	DTAP~SANOFI PASTEUR~C2480AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2191AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF040AA~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B08666H~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0264173	11/01/2006	TX	64.0			F		24 hrs after had chills, confusion, exhaustion, lasted 12 hrs. 48 hrs see above lasted 18 hours.									Y					OTH	PVT	Plavix, Toprol, Zocor, Celebrex.	NONE				1						2	Chills; Injection site nodule; Myalgia; Swelling; Chills; Confusional state; Fatigue	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U2218AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0485F~UNK~~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0265538	11/01/2006	CO	42.0	42		F	10/25/2006	Mild cellulitis. Patient started on Keflex.									U	10/23/2006	10/24/2006	1	NONE	PVT	PVT	NONE	NONE	Heart murmur			1						2	Cellulitis; Cellulitis	FLU3~SANOFI PASTEUR~U2219AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2219AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0265727	11/01/2006	MD	0.79	0	.8	M	10/27/2006	Seriousness criteria other medically significant (OMIC). Initial report received on 10/24/06 from a health care professional. A 10 month old male pt, with no current illnesses, allergies, or past medical history, but who was taking either Zantac or Prevacid (reporter was unsure), had received a first 0.25ml dose, left thigh, IM injection of Fluzone, lot number U2168BA, on 10/20/06. Within 24 hours post immunization, the pt developed left sided facial drooping that would not elevate with smiling, and his left eye would not stay open. He was medically evaluated and diagnosed with Bells Palsy. Diagnostic and treatments received were not reported. The pt had previously received, 15 days prior to this vaccination, a third dose, right thigh IM injection of Hep B vaccine lot number AHBVB301A, on 10/5/06. At the time of this report, the pt had not recovered.				Y					N	10/20/2006	10/21/2006	1		PUB	PUB	Zantac, Prevacid				200602770	1						1	Facial palsy	FLU3~SANOFI PASTEUR~U2168BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265728	11/01/2006	WV	60.0	60		F	10/26/2006	A 60 year old female pt, with no known past medical history, had received an IM, left deltoid injection of Fluzone SV 2006-2007, lot number U2195AA, on 10/4/06. Eight days post vaccination, the pts whole leg went numb. She began to fall, but the felling in her leg returned. Four days after that, she experienced no feeling from her waist down and from both elbows to both hands. She was subsequently admitted to the hospital on 10/16/06. the admitting diagnosis was rule out Guillain Barre syndrome or transverse myelitis. However, per the reporter, it was determined not to be Guillain Barre syndrome. The final diagnosis had not yet been determined. Relevant diagnostic testing included a MRI and lumbar puncture which were negative. The pt was discharged from the hospital on 10/18/06 and was scheduled to follow up with a neurologist and to have an EMG. A Medrol dose pack was prescribed upon discharge. At the time of this report, the pt had not recovered.					Y	3			N	10/04/2006	10/12/2006	8		UNK	UNK					200602710	1						1	Fall; Flat affect; Hypoaesthesia; Myelitis transverse	FLU3~SANOFI PASTEUR~U2195AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0265736	11/01/2006	MI	30.0	30		F	11/01/2006	dizziness, diaphoresis, chest tightness, hives on torso, itching, throat tightness, swollen lips, bloodshot eyes. Took benadryl and prednisone.									Y	10/31/2006	10/31/2006	0		UNK	UNK	None	none	None			1						1	Chest discomfort; Dizziness; Face oedema; Hyperhidrosis; Ocular hyperaemia; Pruritus; Throat tightness; Urticaria	FLU3~SANOFI PASTEUR~U2244AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265738	11/01/2006	IA	53.0	53		F	11/01/2006	Received the vaccination at 0730 10/31/06.  within 1/2 hour started to feel flu like symptoms.  She continued to feel sick to her stomach, became pale.  She reported her arms and legs felt like cement and she had trouble lifting them.  After one hour she had hives.  She was seen by the Dr. by 1000. Dr. did physical and gave benadryl.  She was seen again on 11/1/06 to clear to return to work.				Y					Y	10/31/2006	10/31/2006	0	none	UNK	UNK	Indomethocin XL, Calcium  Multi Vit		Fibromyalgia, osteo-arthritis			1						1	Nausea; Pallor; Sensation of heaviness; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69897~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0265740	11/01/2006	IN	80.0	80		F	11/01/2006	@ 5:00pm on 103106, Patient noticed L arm painful upon movement, no swelling or redness, began to chill but did not take temp. arm so painful patient took a Lortab, and went to bed at 9:00pm. Slept well. This AM arm still sore upon movement and is slightly warm to touch. Still no redness or swelling. Patient took another Lortab this AM. Feels no need to see DR.									Y	10/31/2006	10/31/2006	0		UNK	UNK	Centrum Silver, Detrol LA, Lasix, Oscal, Lisinopril, Toprol, Potassium, Baby ASA, Vit C, Ocuvite	None	Aortic Valve Replacement and Bypass surgery in May of 2005			1						1	Chills; Feeling hot; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71830~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~9570905~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265741	11/01/2006	GA	53.0	53		F	11/01/2006	Redness, swelling and pain at injection site occurred ~6 hours after injection.									Y	10/25/2006	10/25/2006	0	N/A	UNK	UNK	Albuterol, Advair, Fluticasone, Requip, loratadine, fish oil, folic acid	none	asthma			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2244AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0618F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265742	11/01/2006	LA	36.0	36		F	11/01/2006	10/30/06; 15-30 minutes post vaccination experienced pain in arm radiating to elbow and chest.  Developed redness on chest, red blotches on arm & neck; shortness of breath, wheezing & tightness of chest.  See in emergency department within an hour from vaccination.  Treated with Solucortef, Benadryl and after approx 4 hours discharged home.  Around 8:30pm began experiencing same type of symptoms, tightness of chest and wheezing.  Returned to ED at 8:53pm.  Treated with Albuteral sulfate, SoluMedrol, Benadryl and Decadron.  Admitted as in-patient 10/30/06.  Still in-patient as of this report.  11/7/06 Received medical records from hospital  which reveal patient admitted 10/31/06-11/1/06.  Patient became flushed, warm, sick & nauseated with swelling of back & neck pain & swelling within 30 min of flu vax.  Seen in ER & released.  Returned to ER approx 4 hours later with flushing & tight throat.  Admitted for observation.  Received IV steroids & antihistamines.  Had another episode of flushing & throat tightening while hospitalized.  Received additional steroids with improvement.  D/C home on tapering steroids, pepcid & benadryl.  Was referred for allergy testing. LABS: All WNL. Dx: adverse reaction to medical vaccine & early anaphylactic reaction secondary to AE./ss				Y	Y	2			Y	10/30/2006	10/30/2006	0		UNK	UNK	Only birth control	None	Allergy to Demerol; severe reaction December 2005 presumbly from Augmentin, required ventilator support for 1.5 days.			1						1	Anaphylactic reaction; Angioneurotic oedema; Chest discomfort; Chest pain; Dyspnoea; Erythema; Hot flush; Nausea; Pain; Rash macular; Vaccination complication; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71826~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0265743	11/01/2006	NY	48.0	48		F	11/01/2006	Next day developed moderate redness and swelling in arm with fever.									U	10/31/2006	11/01/2006	1	NOne	UNK	UNK		None				1						1	Erythema; Pyrexia; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71353~1~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0320F~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265744	11/01/2006	MD	2.0	2	.7	M	11/01/2006	My son broke out in hives on his face, arms, legs and back.									Y	10/29/2006	10/29/2006	0		UNK	UNK		No.	No.			1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~3~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0265746	11/01/2006	CO	62.0	62		M	11/01/2006	1 degree elevation fever Muscle aches Rapid pulse -- about 100 for 12 hours									Y	10/31/2006	10/31/2006	0		UNK	UNK	Fosamx Lisinopril	None	Allergy to sulfa			1						1	Heart rate increased; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U2219AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265748	11/01/2006	MO	67.0	67		M	11/01/2006	Swollen Left arm, soreness in bicep, swelling moved down to forearm.  It is hard to determine which shot caused the reaction.  Unfortunately, the nurse administered both shots in same arm.  Nurse was reminded of company policy to administer in different arms.									Y	10/17/2006	10/17/2006	0		UNK	UNK	Unknown	Unknown	Unknown			1						1	Pain; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70385~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0618F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265750	11/01/2006	TN	47.0	46		F	11/01/2006	First pt. starting c/o feeling funny, arms tingling, then lips started tingling, then got numb, tougue starting feeling funny, started coughing.				Y					Y	11/01/2006	11/01/2006	0		UNK	UNK		None	None			1						1	Cough; Hypoaesthesia; Malaise; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601411~7+~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0265754	11/01/2006	IA	28.0	28		F	11/01/2006	Allergic reaction- rash progressed quickly down entire right arm.  Arm tingling in both arms.  Complained of dizziness, blurred vision. Puffy under eyes, unable to walk straight, arm swollen. Contacted ER.  Benedryl 5 mg po given and Epinephrine 0.5 ml given L arm subq.  Pt observed for 40 minutes after epi given.  Symptoms cleared.									Y	11/01/2006	11/01/2006	0		UNK	UNK	none reported	none reported	none reported			1						1	Dizziness; Eye swelling; Gait disturbance; Hypersensitivity; Paraesthesia; Vision blurred	FLU3~SANOFI PASTEUR~U2215AA~1~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265755	11/01/2006	CA	1.89	1	.9	M	11/01/2006	22 MO OLD BOY GOT HIS INFLUENZA VACCINE 10/30/06;  HE DEVELOPED FEVER OF 105F AND SEIZURES ON 10/31/06.  HE WAS TAKEN TO LOCAL HOSPITAL VIA AMBULANCE.  LAB WORK AND CT WERE NORMAL AND HE WAS DISCHARGED.  HE FOLLOWED TODAY IN CLINIC AND LOOKS NORMAL WITH A NEGATIVE EXAM AND NO FEVER. 11/7/06 Received medical records from PCP which reveal patient in good health & normal development as of 7/06.  Next vs was for flu fax on 10/30.  Last visit is 11/1 as f/u to ER visit for febrile seizures.  Labs, CT & CXR reported by PCP as WNL but   CT of brain report revealed possible mastoiditis.  Parent refused LP.  Patient was to continue on oral antibiotics./ss  12/1/06 2nd letter faxed to hospital to request medical records/ss 1/9/07 Received medical records from hospital which reveal patient seen in ER on 11/1/06 following seizure activity which included post ictal period in ambulance & ER.  Recent hx of febrile illness with rhinitis & cough.  Temp 103.6 in ER.  Treated with IM antibiotics & given oral antibiotics upon d/c to home FINAL DX:  Seizure; fever; & bronchiolitis.				Y	Y	1			Y	10/30/2006	10/31/2006	1	CBC, RENAL PANEL, URINALYSIS, CT HEAD AND CXR WERE ALL NEGATIVE.  MOTHER REFUSED SPINAL TAP. LABS: CXR revealed infiltrate in bilat perihilar regions.  CT of head was WNL. CBC reported as normal but no report in records received.  BMP was WNL.  Cath UA was WNL.  Parent refused LP.	UNK	UNK	NONE	NO	URTICARIA REACTIVE AIRWAYS Birth HX: Full term NSVD w/o complications. Family HX:  sibling with a seizure disorder.			1						1	Convulsion; Pyrexia	FLU3~SANOFI PASTEUR~U2176EA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0265757	11/01/2006	OR	41.0	41		F	11/01/2006	SOB, DIZZINESS, CONFUSION, HIVES AT THE SITE ARM SWELLED UP, INCREASE PULSE RATE, WHEEZING.			Y						Y	10/25/2006	10/25/2006	0	NONE	UNK	UNK		ASTHMA, VOCAL CORD DYSFUNCTION	MORPHINE, ASA, NSAIDS, LATEX, NUTS, ZELNORM.	SOB,CONFUSION,DIZZINESS,~Influenza (Seasonal) (no brand name)~1~0.00~In Patient		1						1	Confusional state; Dizziness; Dyspnoea; Heart rate increased; Swelling; Urticaria; Wheezing	FLUX~UNKNOWN MANUFACTURER~~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0265764	11/01/2006	OH	2.0	2	.8	M	11/01/2006	Hematuria (blood in urine), proteinuria, and abdominal pain approximately 20 hours after receiving influenza vaccine. Exam normal including blood pressure. Normal ASO, serum albumin, urine Ca/creatinine ratior, urine culture. Complement profile pending. Patient will have followup exam 1 week after incident.				Y					U	10/24/2006	10/25/2006	1	see above	UNK	UNK		none	allergies			1						1	Abdominal pain; Haematuria; Proteinuria	FLU3~SANOFI PASTEUR~V2174EA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265770	11/01/2006	PA	73.0	73		M	11/01/2006	Left bottom side of arm, red, hot, painful to touch since Monday 10/30/06									U	10/30/2006	10/30/2006	0		PVT	OTH	Lipitor, Lisinopril, Acyclovir, Folic acid, Mag Cit,	NONE	Hyperlipidemia, HTN, cold sores, DM, Chronic pain.			1						1	Erythema; Feeling hot; Pain	FLU3~SANOFI PASTEUR~U2167MA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265771	11/01/2006	OR	66.0	65		F	11/01/2006	6x6 red, swollen, warm to touch area right deltoid. F/u 11/02/06, apply ice take Ibuprofen 600mg TID.										10/30/2006	10/31/2006	1	BP 138/80	PUB	UNK						1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U2218AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0601F~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265772	11/01/2006	FL	19.0	19		M	11/01/2006	Pt received Fluarix vaccination in left deltoid, one day later presented with 2 lesions his arm (c) diagnosed as erythema multiforme - appeared one day after vaccination.									U	10/24/2006	10/25/2006	1	None performed	MIL	MIL	NONE	NONE	NONE			1						1	Erythema multiforme; Skin ulcer	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA219BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0265773	11/01/2006	CA	35.0	35		F	10/30/2006	Vaccine administered IM Left deltoid on 10/25/2006. Pt reported back to clinic and seen on 10/26/2006 with large erythematous induration, tenderness, and itching to left deltoid at injection site with red blotches all over body and facial flushing. Pt given prescription Atarax 25 mg PO Q4 PRN and instructed to go to ER if symptoms worsen.									Y	10/25/2006	10/26/2006	1		PVT	PVT			DM-2, Chronic etoltism, depression, obesity, HTN			1						1	Erythema; Flushing; Injection site erythema; Injection site induration; Injection site pain; Injection site reaction; Pruritus	FLU3~SANOFI PASTEUR~V2186AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB068BB~2~IM~RA~HEP A + HEP B (TWINRIX)~1	USA		Influenza
0265774	11/01/2006	MI	48.0	47		F	10/30/2006	Erythema, Edema, warmth to touch. 10/20/06 10x7 in size. Treatment with Levaquin 500mg 1tab x 10 day, Claritin 10 mg daily.				Y						10/27/2006	10/27/2006	0		UNK	UNK						1						1	Erythema; Feeling hot; Oedema	FLUX~UNKNOWN MANUFACTURER~71033~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0265775	11/01/2006	TX				F	10/18/2006	Please see attached.														UNK	UNK						1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70383~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265776	11/01/2006	PA				U	07/19/2006	A newborn patient in a hospital setting was given influenza vaccine instead of the intended Hepatitis B vaccine. First vial sent by Pharmacy was the correct product, but it was dropped and had to be replaced. The second vaccine was sent and the baggie was labeled correctly but it contained the Fluarix instead of the Engerix-B. Products look very similar. Increased monitoring of patient with no apparent harm.									Y					PUB	OTH						1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0265778	11/01/2006	PA	53.0	53		F	10/24/2006	Facial swelling especially around eyes with sneezing and excessive tearing of eyes, approx 1 hour after injection. 50mg Benadryl taken by mouth per order of Dr, eye swelling gradually decreasing.									Y	10/24/2006	10/24/2006	0		PUB	PVT	NONE		Sulfa			1						1	Eye oedema; Face oedema; Lacrimation increased; Sneezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70737~1~~GM~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265779	11/01/2006	OH	68.0	67		M	10/24/2006	Left arm was swollen, red, hot, had induration, sore. (only in the arm) x 3 days. Pt did not take any medication.									Y	10/16/2006	10/16/2006	0		OTH	PUB						1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site pain; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69423~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0485F~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265781	11/01/2006	TX	35.0	34		F	10/16/2006	Vaccine administered at 3:30pm 10/09/06 shortly after pt began itching and rash on arms legs torso, scalp and neck. Raised red welts. Was seen in Employee Health Clinic the next day. TX'D with IM and oral steroids and PO Benadryl.				Y					Y	10/11/2006	10/11/2006	0		OTH	OTH	Lexapro	NONE	General anxiety disorder.			1						1	Erythema; Rash pruritic; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA218BA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0265782	11/01/2006	CA		54		F	10/14/2006	Pain down arm where vaccine administered. Patient described lump feeling, pain 8/10. 3:20 BP 109/71, P 84; 3:30 BP 112/70, P 93. 10/16/06 Patient reported swelling went down evening of 10/14 and she was not having any further problems									Y	10/14/2006	10/14/2006	0	EMS called and assessed patient. Said possible vagal response; pain from vasoconstriction.	OTH	PVT		NONE	Migraines - medicated with Zomig			1						1	Injection site mass; Injection site swelling; Pain; Syncope vasovagal; Vasoconstriction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71215~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265784	11/01/2006	NM	31.0	31		F	10/21/2006	Patient experienced dizziness and felt as though she was going to faint. Numbness in arm injection was given in left. Difficulty breathing when trying to speak, very pale. 911 called - patient started to recover on her own. 911 assessed and patient was able to go home with family. Asked by 911 to follow up with primary physician.									Y	10/21/2006	10/21/2006	0	NONE	PUB	OTH	NONE	NONE	NONE			1						1	Dizziness; Dyspnoea; Hypoaesthesia; Pallor; Syncope	FLU3~SANOFI PASTEUR~U2240AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265785	11/01/2006	IA	1.97	1	1	M	10/23/2006	Rash, itchy, redness, rough.				Y					Y	10/19/2006	10/20/2006	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Erythema; Pruritus; Rash	FLU3~SANOFI PASTEUR~U2174DA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265786	11/01/2006	IA	37.0	37		M	10/27/2006	Received Fluzone vaccine 0.5 IM RD. Within 30 minutes of receiving vaccine, experienced facial swelling, became real tired and went to sleep. Also has had mid back pain. Swelling decreased this AM. This person presented to this clinic at 0815 10/27/06. Positive orbital swelling. Given Benadryl  PO. BP 104/80, AP 76. No acute distress at this time.									Y	10/26/2006	10/27/2006	1		PUB	PUB	NONE	NONE; mild cold symptoms.	ASA allergy			1						1	Back pain; Face oedema; Fatigue; Somnolence	FLU3~SANOFI PASTEUR~U2274AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265787	11/01/2006	MN	24.0	24		F	10/26/2006	Patient received FluMist while pregnant. Due 3/07.										10/26/2006	10/26/2006	0		PVT	UNK		NONE	NONE			1						1	Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~560434B~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0265788	11/01/2006	CA	37.0	37		F	10/23/2006	Fever, myalgias, HA and rash starting on day of FluMist administration.									N	10/14/2006	10/14/2006	0		MIL	MIL	NONE	NONE	NONE			1						1	Headache; Myalgia; Pyrexia; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500432P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0265789	11/01/2006	NY	72.0	71		F	10/25/2006	5 days - very tender, swollen and hard at site of injection. 2 days - body ache all over, chills, low temperature - very tired. 2 days - rash on arms, legs, chest, stomach. 2nd Day, took Advil for pain in arm - very sore. 3rd day - more rash and itches now - took Benadryl. 1st day only - sore throat. Most symptoms gone Sunday.									Y	10/17/2006	10/18/2006	1		PUB	OTH	Evista; Timolol; Norvasc; Aspirin	NONE	Penicillin allergy			1						1	Chills; Fatigue; Hypothermia; Injection site induration; Injection site pain; Injection site swelling; Pain; Pharyngolaryngeal pain; Pruritus; Rash	FLU3~SANOFI PASTEUR~U2213AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1037P~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265790	11/01/2006	NY	74.0	74		F	10/25/2006	Patient called complained of bleeding from site of vaccination - several hours after placement. Seen in office, positive swelling, positive pain, site reddened and warm to touch. 6-8cm induration. Advised cool compresses, Tylenol Q 6H.									Y	10/23/2006	10/23/2006	0		PVT	PVT		NONE	ASHD			1						1	Injection site abscess; Injection site erythema; Injection site induration; Injection site pain; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69428~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0899F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265791	11/01/2006	TX	82.0	82		M	10/28/2006	Fever 101 evening of 10-25-06. Rash on left arm (shot administered) 10-26-06 - 10-27-06									Y	10/25/2006	10/25/2006	0		UNK	UNK						1						1	Pyrexia; Rash	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265792	11/01/2006	AL	0.83	0	.8	F	10/27/2006	Last PM, around 8 PM, 10/26/06, pt felt warm and T 102, received Flu shot at approx 2:30 10/26/06 at 0230 AM, temperature (rectal) was 104.5. This AM (10/27/06 at 0930, T 103.2) In office, T 98.9 rectal.				Y					Y	10/26/2006	10/26/2006	0	CBC - wnl	PVT	PVT		NONE	NONE			1						1	Pyrexia	FLU3~SANOFI PASTEUR~U2246AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265793	11/01/2006	CA	56.0	56		F	10/25/2006	1-2 hours after shot got uncontrollable severe diarrhea that lasted 3 days. Also got a red circle the side of baseball around injection site that lasted for about a week. This is the flu shot I reacted to.									Y	10/03/2006	10/03/2006	0		OTH	PVT	NONE	NONE	NONE			1						1	Diarrhoea; Injection site erythema	FLU3~SANOFI PASTEUR~U2186AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265794	11/01/2006	ID				F	10/26/2006	Received flu shot on 10/25/06. Developed a rash which resembled skin being rub with sand paper.									Y					PVT	PVT						1						1	Skin irritation	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA208BA~UNK~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0265795	11/01/2006	PA	73.0	73		F	10/26/2006	Injection left large red hard lump - which stayed for three days. It was very warm in spite of ice pack. General pain and discomfort.									Y	10/11/2006	10/11/2006	0		OTH	UNK		NONE	NONE			1						1	Discomfort; Injection site erythema; Injection site induration; Injection site mass; Injection site warmth; Pain	FLU3~SANOFI PASTEUR~U2013EA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265798	11/01/2006	IN	75.0			F		Hives on eyes and face. 2005 flu shot. I am not allergic to eggs or shellfish. Just wanted you to know. No need to follow up.									Y					PUB	UNK		NONE				1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0265799	11/01/2006	MD	2.0			M	10/23/2006	Local reaction to left leg following flu shot. 8.5 by 10.5cm local reaction, red, hot and spreading.									Y					PVT	PVT	Albuterol; Flonase; Zithromax	Cough; Wheezing; Bronchitis	NONE			1						1	Injection site erythema; Injection site reaction; Injection site warmth	FLU3~SANOFI PASTEUR~U2174EA~4~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265800	11/01/2006	WI	28.0	28		M	10/27/2006	None stated.										10/26/2006	10/26/2006	0		UNK	UNK						1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2242AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265804	11/01/2006	WI	35.0	35		F	10/26/2006	Employee received Influenza vaccine at 11:00 am 10/25/2006 at 13:05 reported to occupational health services with hives face, mouth, neck, trunk and arms, hands tingling, by mouth Diphenhydramine 50 mg given 1310.  Employee stated chest tightness, asthma like signs and symptoms. Three 1:1000 Epi given SQ taken to emergency room.				Y					Y	10/25/2006	10/25/2006	0		PVT	UNK		NONE	allergic beestings, Guiafensin, animal dander.			1						1	Chest discomfort; Dyspnoea; Paraesthesia; Urticaria	FLU3~SANOFI PASTEUR~U2212AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265805	11/01/2006	WA	55.0	55		F	10/27/2006	Erythema, edema.  CBC-6200 WBC with 65/35% L/M.  BENADRYL over the counter as directed.									Y	10/20/2006			CBC (results as above)	OTH	UNK		NONE	sulfa allergy			1						1	Erythema; Oedema	FLUX~UNKNOWN MANUFACTURER~69425~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0089F~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265806	11/01/2006	WA	67.0	67		F	10/27/2006	Mild to moderate erythema/edema at injection site. ZYRTEC 10mg every day/ice to site.									Y	10/23/2006	10/24/2006	1		PVT	PVT	LISINOPRIL, SYNTHROID	NONE	SULFA, CODEINE, ULTRAM			1						1	Injection site erythema; Injection site oedema	FLUX~UNKNOWN MANUFACTURER~69425~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0089F~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265807	11/01/2006	MO	4.0	4		F	10/31/2006	10/27/2006 at 4 year well check administered Dtap, Polio, ProQuad, Flu-mom advised Sunday following injection sites red and hot and developed a rash- seen at urgent care.									Y	10/27/2006	10/29/2006	2		PVT	UNK		NONE				1						1	Injection site erythema; Injection site rash; Injection site warmth	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B035AA~5~~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~K2275AA~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~20001~4~~LL~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~0971F~2~~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0265809	11/01/2006	PA	52.0	52		F		Fever, rash, myalgias, nausea, vomiting, diarrhea.				Y					Y	10/25/2006	10/27/2006	2		OTH	OTH	Zeta, Cymbalta, Flonase		VICODIN, seasonal allergies			1						1	Diarrhoea; Myalgia; Nausea; Pyrexia; Rash; Vomiting	FLU3~SANOFI PASTEUR~U2218AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265810	11/01/2006	MD	7.0	7		F	10/31/2006	Woke up Sunday, 10/29, in the morning with fever of 101.7 and vomited.  Felt achy.  Parent gave TYLENOL/ADVIL.									Y	10/24/2006	10/29/2006	5	NONE	OTH	PUB	NONE	NONE	lactose intolerant			1						1	Pain; Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500438P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0265811	11/01/2006	FL	33.0	33		F	11/01/2006	Fever 101 degrees, eyes swollen. tightness in chest, body aches.  MOTRIN for temperature and aches.									Y	10/31/2006	11/01/2006	1	NONE	OTH	PVT		NONE	NONE			1						1	Chest discomfort; Eye swelling; Pain; Pyrexia	FLU3~SANOFI PASTEUR~42240AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0247515	11/02/2006	MN	65.0	64		F	11/02/2006	Pt developed redness and pain at site of injection in right arm, progressively got worse.  Pt developed chills, nausea, and fever.  Oral doxycycline was started on outpatient basis.  Fever and malaise progressed.  Pt was admitted to hospital with diagnosis of cellulitis at injection site. DC DX: for DOS 11/9-11/15/05 Cellulitis due to pneumovax infection with erythema Drug reaction to clindamycin, now an allergy diarrhea apparently becoming more firm and resolving other past medical history is hyperlipidemia, hypertension, history of migraines. leukocytosis that has since resolved cultures are negative at this time					Y	6			Y	11/02/2005	11/02/2005	0	cultures are negative at this time	UNK	UNK	Fosamax, Inderal, Imitrex, ASA, Ativan, Mobic, Dyazide	none noted	Osteoporosis, migraine, hypertension, hyperlipidemia			1						3	Cellulitis; Chills; Condition aggravated; Diarrhoea; Injection site erythema; Injection site pain; Injection site reaction; Malaise; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|PPV~MERCK & CO. INC.~~UNK~IM~RA~PNEUMO (PNEUMOVAX)~3	USA	Hospitalisation	Influenza
0265829	11/02/2006	MA	81.0	81		M	10/25/2006	Patient appeared to have lost conscious. Wife thought it was due to drop in glucose patient did not have breakfast. Wife gave a glucose tab. Patient appeared to begin to respond. We had called EMT when they arrived the indicated patient blood pressure was low he was then taken to ER for further evaluation.				Y					Y	10/25/2006	10/25/2006	0		OTH	PVT		NONE				1						1	Blood pressure decreased; Loss of consciousness	FLU3~SANOFI PASTEUR~U2165EA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265830	11/02/2006	GA	51.0	51		F	10/15/2006	Fever/severe pain and swelling at inoculation site/redness and infection at site of pneumococcal vaccine/chills/overall pain and fatigue/headache				Y					Y	10/06/2006	10/07/2006	1		OTH	OTH		NONE	NONE			1						1	Chills; Fatigue; Headache; Injection site erythema; Injection site infection; Injection site pain; Injection site swelling; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU5204AA~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1037P~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0265844	11/02/2006	OH	67.0	66		F	10/23/2006	10/20/2006 1pm pt c/o chest pain from one shoulder to the other denies SOB, But sounds SOB and anxious over the phone. Has had previous heart attacks x 2. She is alone at home advised to call 911 states she will. Rn 10/23/06 call to pt pt was admitted for heart problems which she said was unrelated to flu vaccine.  Patient developed chest pain and a rapid heartbeat approximately 1.5 hours after Fluvirin.  911 was called and she presented in the ER with atrial fibrillation with rapid ventricular response. MI was ruled out via EKG and cardiac enzymes.  Patient coverted to sinus rhythm without intervention and was admitted for observation. Medications were adjusted and the patient was dicharged home.  No discharge summary written. Assessment on date of discharge: 1. Chest pain.  Myocardial Infarction ruled out. 2. Cardiac dysrhythmia 3. Hypertension. 4. DM, anxiety, GERD, chronic back pain. Of note:  Medical record also included 3 additional hospital admissions over the next week for cardiac issues.  Patient later recalled falling on her chest and hitting her pacemaker several weeks ago.  A later final DX (10/29/06) included questionable pacemaker abnormality.					Y	3			Y	10/20/2006	10/20/2006	0	Cardiac enzymes (-)	PUB	PVT	MicroK, Diltiazem, Lipitor, Metaprolol, Trazodone, Lasix, Lexapro, Humulin, Metformin, Zestril, prevacid, ASA, nitroglycerine PRN, Avandia, docusate PRN		Atherosclerotic heart disease, MIx2, hypertension, CHF, pacemaker, diabetes, anxiety, GERD, chronic back pain.  Allergies:  Sulfa, tape.			1						1	Anxiety; Back pain; Chest pain; Diabetes mellitus; Dyspnoea; Gastrooesophageal reflux disease; Hypertension	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71216~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0265848	11/02/2006					M	10/30/2006	Seriousness criteria other medically significant (OMIC). Initial report received on 10/24/06 from the pts daughter who is also a health care professional. A male pt, age not specified, had received an injection of influenza vaccine, manufacturer not reported, lot number not reported, on an unspecified date in 1995. Two weeks post vaccination, the pt developed peripheral vision loss. Recovery status was not reported. This event was reported secondary to an inquiry, and the reporter stated, he is now suffering from pulmonary fibrosis and needs flu vaccine. Additional details were not provided.				Y					U					UNK	UNK					200602777	1						1	Visual field defect	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0265852	11/02/2006	IL	2.75	2	.8	F	11/01/2006	Thirty min after Fluzone vaccine, Pt developed swelling to eyelids, hyperemia to face, hives on chest and generalized pruritus.				Y					U	11/01/2006	11/01/2006	0		PVT	PUB		NONE	Hypoplastic left heart / Transposition of great vessels			1						1	Eyelid oedema; Hyperaemia; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2275AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265854	11/02/2006	NV	58.0	58		M		Swelling spot and soreness where flu shot was given on 10/07/2006. Pt abo stated that swelling was Y2 dollar size. On exam today induration 1.5 cm x 1 cm erythema and swelling at injection site no adenopathy no numbness decreased rash and profusion. No evidence of secondary infection. Skin warm but not hot.									Y	10/07/2006	10/08/2006	1	NONE	PUB	PUB						1						1	Feeling hot; Injection site erythema; Injection site induration; Injection site pain; Injection site swelling; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA215AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0265855	11/02/2006	NV	50.0	50		U		I received a Flu shot and during the day my arm hurt a lot. The next day my arm still hurt and I noticed a big bruise on my arm. I still have the bruise and my arm still hurt.									Y	10/07/2006	10/08/2006	1		UNK	UNK						1						1	Contusion; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA215AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0265856	11/02/2006	CA	58.0	58		M	10/29/2006	Pt developed chills, coughing, sneezing, and sweats within 20 minutes after vaccines administered. Had temp to 103, positive cough producing copious mucous within one day.									Y	10/12/2006	10/12/2006	0		PVT	PVT		COPD; chronic congestion	COPD, Type II DM, HTN, tobacco dependencies			1						1	Chills; Cough; Hyperhidrosis; Pyrexia; Sneezing	FLU3~SANOFI PASTEUR~U2193AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~089F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265857	11/02/2006	VT	1.0	1	.0	F	10/30/2006	Rash around inj site and on buttocks. Treated with Benadryl.									Y	10/27/2006	10/28/2006	1	Allergy Testing	PVT	PUB	Tylenol	NONE	NONE			1						1	Injection site rash	FLU3~SANOFI PASTEUR~U217UEA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~1091F~1~~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0265858	11/02/2006	CT	40.0	40		F	10/30/2006	Pt called on 10/30 at 10:15 AM to report she developed rash on bilateral and back areas of neck 4 days after vax administration. Notes itch at times - rash has lessened but still can feel bumps on skin. Denies problem at site of injection - Had gotten vax x 15 yrs without problems noted. Did not Tx or seek medical attention. Is recovering.										10/18/2006	10/22/2006	4		PUB	PVT		NONE	NKDA - Hx: RA			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U2275AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265859	11/02/2006	IA	70.0	70		F	10/30/2006	Left deltoid .6cm x .3cm blister area where injection was given (Noted 10/26/06 by home care aide)									Y	10/24/2006	10/26/2006	2		OTH	OTH	Imdur, Prednisone, Glipizide, Compazine, Lipitor, Lexapro, Prilosec, Hydrocodone Acetaminophen, Coumadin, Oxygen, Fosamax	None	Coumadin Therapy, Osteoporosis			1						1	Blister	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70279~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265861	11/02/2006	FL	72.0	72		F	10/24/2006	Patient called at 11:00 am on 10/24/06. Received flu vaccine on 10/23/06 around 1:00 pm. Approximately 1 1/2 hours after injection patient complained bitter taste in mouth which she still had as of this next day conversation. Patient denies any SBO, swelling in mouth, SOB, urticaria. Advised to go to PCP or local ER and notify me of results. I called patient on 2 separate dates to checkon her but she would not speak to me. She did call in & talk to another nurse & she said her son was a physician & she was returing ho,e to be checked by him. No further correspondence with her.										10/23/2006	10/23/2006	0		OTH	PVT		N/A				1						1	Dysgeusia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71216~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265870	11/02/2006	NY	0.0			F	11/01/2006	Right arm mild swelling and warmth from shoulder to elbow.  Injection was in deltoid.  very pruritic from shoulder to hand on right only.									Y	10/30/2006	10/31/2006	1	none	UNK	UNK	none	none	no allergies			1						1	Feeling hot; Oedema peripheral; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71033~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265871	11/02/2006	FL	20.0	20		F	11/02/2006	DIZZY, GROGGY, AND TIRED.									Y	10/31/2006	10/31/2006	0		UNK	UNK	Miralax, Flonase, Prilosec, Prozac, Advair, Ortho-tri-cyclen	x	Asthma; Allergic to adaptic bandages, cingulair			1						1	Dizziness; Fatigue; Somnolence	FLU3~PFIZER\WYETH~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0265873	11/02/2006	SC	51.0	51		F	11/02/2006	10/21/06 AM, after vaccines administered on 10/20/06:  experienced upper left arm tenderness with heat and progressive hardness throughout the day - increased tenderness with onset of general body aches accompanied by slight fever (98.9 - usual body temp is 97).  Also experienced stomach pain with diarrhea.  10/22/06: same symptoms as 10/21/06. 10/23/06:  red splotches on upper arm - tender and hot - less general body aches and arm less tender and hot.  Each subsequent day a little better.  10/23/06: called MD who advised: not take pneumonia vaccine again; apply ice' and take Benadryl 25 mg t.i.d. 10/24/06: Saw MD for allergy shots administered in right arm.				Y					Y	10/20/2006	10/21/2006	1	NONE	UNK	UNK	Triam HCTZ 1 daily each AM Zyrtec 10mg 1 at hs Effexor 1 at hs Lo-ovral 1 at hs Advil PRN	NONE	Allergies to mold, grasses, and trees.  Some food sensitivities.  Receive allergy shots every 1-2 weeks		SC0620	1						1	Abdominal pain upper; Diarrhoea; Injection site induration; Injection site warmth; Pain; Pyrexia; Rash maculo-papular; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71209~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0601F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0265876	11/02/2006	TX	69.0	69		F	11/02/2006	Acute Pancreatitis Onset of nausea abd pain, previous biliary pancreatitis 1998.				Y	Y	8			Y	10/24/2006	10/24/2006	0	On admission lipases over 26,000. WBC 30.2, amylase 3206, albumin 4.0, AST 21, ALT 33, alk phos 85.	UNK	UNK		COPD Chronic Nerve Pain	Allergies Codeine and Sulfa			1						1	Laboratory test abnormal; Pancreatitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71033~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0265878	11/02/2006	NC	65.0	65		F	11/02/2006	PATIENT RECEIVED PNEUMOVAX ON 10/23/2006.  SHE EXPERIENCED HIVES AROUND INJECTION SITE, REDNESS, TENDERNESS, AND SORENESS ON 10/25/2006.  ON 10/26/2006, SHE EXPERIENCED A FLAT, RED RASH ON HER CHEST AND BREASTS.  SHE HAS BEEN TAKING BENADRYL WHICH HAS DECREASED THE SYMPTOMS.									Y	10/23/2006	10/25/2006	2	NO	UNK	UNK		NO	NO			1						1	Injection site erythema; Injection site pain; Rash; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70277~5~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1048P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265885	11/02/2006	WI	36.0	36		F	11/02/2006	Had the flu shot approx 1pm on 10/31/06.  Approx 4 hours later, had two big hives on my neck and felt acky/sick to my stomach.  About 2:00am woke up with tight chest and went back to bed.   About 6:00am, got up for work and my chest was so tight I was crunched over to catch my breath.  This lasted for about 10 minutes and then the chest tightness went in waves, not constant.  I also had a rash on my left side of my kneck for about 1 hour.  This tightness went on for most of the morning but by afternoon was gone.  I did have a headache in the morning, but that did go away  Today,  11/2, I woke up for work and my chest was so tight, for a good 20 minutes.  I did call my husband as I was worried.  I walked around to try and get by blood flowing and it seemed to subside a bit.  The tightness continues still, just in waves.  I also feel a bit feverish(not sure I have an acutal temperature),have a slight headache and am a little light headed. Sorry..I sound like a hypocondriac here but I wanted to share all my symptoms.									U	10/31/2006	10/31/2006	0		UNK	UNK	none	none	none			1						1	Chest discomfort; Dizziness; Dyspnoea; Nausea; Pain; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLKA201AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0265886	11/02/2006	MA	21.0	21		F	11/02/2006	Paleness, dizziness, feeling of being overheated (did not take temperature, so possibly not a fever), vomiting.									Y	11/01/2006	11/02/2006	1		UNK	UNK	ibuprofen	none	mild asthma			1						1	Dizziness; Pallor; Vomiting	FLUX~UNKNOWN MANUFACTURER~~7+~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0265889	11/02/2006	MI	29.0	29		F	11/02/2006	Received flu vaccine on 10-26-06. First time ever receiving vaccine. Diarrhea on 10-27-06. 10-28-06 developed rash on face and trunk, felt lightheaded and dizzy. Treated in ED with Benadryl. 10-29-06 Rechecked in ED.  Rash gone.  Very sleep from Benadryl.				Y					Y	10/26/2006	10/28/2006	2	None	UNK	UNK		One week prior to vaccine, had fever, cough, chest cold for 2 weeks.  Treated with Robitussin and Sudafed Cold tablets.	Seasonal allergies, pollen allergy, Prilosec allergy.			1						1	Diarrhoea; Dizziness; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua206aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0265891	11/02/2006	FL	38.0	38		F	11/02/2006	Rash to face and neck spreading to lower part of the body.  Appeared 4 hours after vaccine.				Y					Y	11/01/2006	11/01/2006	0		MIL	OTH		none	none			1						1	Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500429P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0265892	11/02/2006	TX	41.0	41		F	11/02/2006	Felt achy 6 hours after getting Tdap and flu shots (Tuesday); left arm warm and sore, by the next day (Wednesday) felt body aches and warmth progressing to fever by evening, 100.4 - 101 F, took Ibuprofen for fever and on Thursday had redness and induration on left upper arm.									U	10/31/2006	10/31/2006	0	T = 98.2 F	UNK	UNK	Zpack	upper respiratory infection				1						1	Feeling hot; Injection site erythema; Injection site induration; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71926~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C2609AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0265894	11/02/2006	CO	37.0	37		F	11/02/2006	Employee c/o skin flushing, itching, scratchy throat and ears, shortness of breath shortly after receiving the Influenza vaccine. Employee treated at emergency room with Epi 1:1000 0.5 SQ left arm;benedryl 50 mg. IVSP; Solumedrol 125 mg IVP; Zofran 4 mg IVP. Employee sent home on Benedryl P.O. 4 times daily for next five days and Prdnisone dose pack. Employee to follow-up with primary care physician.				Y					Y	10/31/2006	10/31/2006	0		UNK	UNK	none	none	Allergy to compazine, gramicidin othalmic.			1						1	Dyspnoea; Flushing; Pharyngolaryngeal pain; Pruritus	FLU3~SANOFI PASTEUR~U2193AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265895	11/02/2006	MI	11.0	11		M	11/02/2006	Patient had uticaria after administration of influenza and DTap vaccinations.				Y					N	10/31/2006	10/31/2006	0		UNK	UNK	Albuterol and Nasonex.	Asthma and allergic rhinitis.	Asthma, allergic rhinitis, allergy to amoxicillin and benadryl.			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2201BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B007AA~1~IM~LA~TDAP (BOOSTRIX)~1	USA	Emergency room visit	Influenza
0265896	11/02/2006	NC	56.0	56		F	11/02/2006	Received flu shot around 10:30 am on 10/26/06; by 9:00 am the next morning, had migraine headache.  Pain in headaches increased; called doctor and received pain medication and prescription for Imitrex.				Y					N	10/26/2006	10/27/2006	1	Doctor's visit and chiropractor's visit.	UNK	UNK		None known.	Allergies			1						1	Headache; Hypersensitivity; Migraine	FLUX~UNKNOWN MANUFACTURER~Unknown~3~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0265897	11/02/2006	IL	67.0	67		F	11/02/2006	By 11 PM a nickel sized red spot appeared; by 7 AM on Sun.10/8 raise in temp.; by 8 PM temp was 102.2 and redness 3x5 card size, very hot and painful; I took a Tylenol PM; Mon.AM 10/9 temp down to 100.2, Pain and stiffness in arm  - redness continued to spread past elbow and completely around arm with light swelling all of Mon. and Tues. Felt 'lousy'in general; Tues. temp dropped to 99.0 and Wed. pain lessened, redness continued, temp went to 98.3 (still high for me); Thurs 10/9 temp 97.6(my usual range)arm began to itch, redness started to break-up, arm heat subsided, arm ached.  By Sat. 10/11 arm still achy, redness continues to fade away. Over the next 3-4 days reddness faded out and all itching stopped I returned to feeling fine again. NOTE: this was more of a reaction than I had with previous vaccination in 2001 then I had only rednesss and sore arm.  Both in 2001 and this time both flu and this were given in the same arm (left)due to lack of lymph system in right arm.									Y	10/07/2006	10/08/2006	1		UNK	UNK	Asacol,Celebrex,Cozar,Generic for Glucovance, Lovastatin, Actos	None	Crohns, Diabetes			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Pain; Pruritus; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265899	11/02/2006	GA	1.02	1	.0	M	11/02/2006	PERSISTANT CRYING LASTING GREATER THAN 24 HOURS.				Y					Y	10/31/2006	10/31/2006	0		UNK	UNK	BENADRYL, MOTRIN, TEETHING TABS,AXID		GERD			1						1	Crying	FLU3~SANOFI PASTEUR~U2177AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~0828F~1~SC~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0265900	11/02/2006	IL	57.0			M	11/02/2006	HIV+ patient. Trivalent influenza vaccine (Sanofi) administered 10/24/06.  72 hours vaccine, patient reported painful left-sided facial rash.  Patient examined 11/2/06 - symptoms consistent with herpes zoster. Rash resolving, no post-herpetic neuralgia.  No hearing or visual complications.									Y	10/24/2006	10/27/2006	3	CD4 count=195 (9/25/06)	UNK	UNK	Truvada, Sustiva, Bactrim	No	HIV			1						1	Herpes zoster; Pain; Rash	FLU3~SANOFI PASTEUR~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265901	11/02/2006	NC	61.0	61		F	11/02/2006	Unknown.  Patients husband came pharmacy at ~ 12pm 11/02 mentioning that his wife had passed away in the evening. Pharmacist manager is a friend of the family and relayed on information on to myself that was running a flu clinic at that location today. 11/9/06 Received Death Certificate which reveal COD as ischemic heart disease and HTN with insomnia, hypothyroidism and chronic bronchitis as contributing factors.	Y	11/02/2006							N	10/31/2006	11/02/2006	2		UNK	UNK	Lisinopril, Thyroid, Protonix, Detral, Premarin, Colestid		Allergies:  Penicillin, Tetracycline.  Medical Conditions: Several			1						1		FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601311~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Results in Death	Influenza
0265902	11/02/2006	VA	40.0	40		F	11/02/2006	24 hours after receiving the flu shot, I had difficulty breathing, tightness in the throat and chest, itching, and a rash on the left arm.  I went to a local Patient First, where I received a shot to stop the itching, and a shot of steriods for the breathing difficulties.  In addition, I was given a 6 day steriod pack to take beginning on 11/2/06.  The flu shot was received on 10/31/06 at appox noon, the reactions begin on 11/01/06 at appox 5 PM.				Y					Y	10/31/2006	11/01/2006	1		UNK	UNK	Amazcort Zoloft Albuteral	Diabetic Asthma	diabetic asthma			1						1	Dyspnoea; Throat tightness	FLUX~UNKNOWN MANUFACTURER~~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0265903	11/02/2006	IL	19.0	19		F	11/02/2006	Chest tightness and coughing (15 minutes post injection) relieved by albuterol inhaler, 2 puffs. Some dizziness noted. No local injection site reaction noted. Recipient has history of asthma. Paramedics called. No additional intervention or treatment was required. Pulse and BP normal.									Y	11/01/2006	11/01/2006	0	BP: 120/80  Pulse: 88	UNK	UNK	albuterol metered dose inhaler	autoimmune disorder (unspecified)	latex allergy described (not MD verified)			1						1	Chest discomfort; Cough; Dizziness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71643~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265904	11/02/2006	OH	46.0	45		M	11/02/2006	Patient developed Oculorespiratory Syndrome w/in 48 hours of receiving flu vaccine.  Patient has red eyes, Hoarseness, tightness in chest, short of breath, nasal congestion, bloody sputum, low grade fever.				Y					N	10/23/2006	10/25/2006	2	Chest Xray	UNK	UNK	albuterol	none present	asthma			1						1	Chest discomfort; Dysphonia; Dyspnoea; Haemoptysis; Nasal congestion; Ocular hyperaemia; Pyrexia	FLU3~SANOFI PASTEUR~U2217aa~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265906	11/02/2006	CA	0.0			F	11/02/2006	Approx. 5-15 min after receiving flu shot report of female resting in parking area. Through Vietnamese neighbor reported feeling weak, headache and dizzy. Had not eaten that AM. Denied heart problems or diabetes. 911 called to check patient.  Vitals were within range but did take her to ER because very unstable and weak.				Y					U	11/02/2006	11/02/2006	0	unknown	UNK	UNK		unknown				1						1	Asthenia; Dizziness; Headache	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70384~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0265907	11/02/2006	CA	36.0	36		F	11/02/2006	Severe Headache, Breathing difficulty, back pain and soreness, arm soreness, muscle soreness, irritability, odd taste in mouth.				Y					U	11/01/2006	11/01/2006	0		UNK	UNK	Metformin XR	none	PCOS, Asthma			1						1	Back pain; Dysgeusia; Dyspnoea; Headache; Irritability; Myalgia; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0265913	11/02/2006	IA	70.0	70		F	11/02/2006	The evening of flu shot pt experienced localized reaction of warmth, redness to site with some welts et light red raised rash to upper arm with itching x 4-5 days.									Y	10/25/2006	10/25/2006	0		PVT	UNK			PCN, Keflex			1						1	Injection site erythema; Injection site rash; Injection site swelling; Injection site warmth; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2273AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265914	11/02/2006	PA	57.0	57		M	11/01/2006	Pt received TD left deltoid and pneumovax and flu vaccine right deltoid on 10/30/06. Seen here 11/01/06 achy and fever also right deltoid red and swollen.									Y	10/30/2006	10/31/2006	1		PVT	UNK						1						1	Injection site erythema; Injection site oedema; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2167MA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~06746~UNK~~RA~PNEUMO (PNEUMOVAX)~1|TD~AVENTIS PASTEUR~U1786DA~UNK~~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0265915	11/02/2006	IN	24.0	24		F	11/02/2006	Student had Fluzone injection on 10/25/06. Student stated 4 hours after injection, developed temp 102, chills, body aches and had numbness in the roof of mouth. Student took 2 Benadryl and 2 Tylenol, went to bed and felt better in the am.									Y	10/25/2006	10/25/2006	0		PUB	PVT	NONE					1						1	Chills; Hypoaesthesia; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2165CA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265916	11/02/2006	LA	67.0	66		M	11/02/2006	Had to go to ER, Benadryl did not help much had to take an Epinephrine injection which resolved the problem. Similar reaction last year after taking a flu, pneumonia and using an albuterol inhaler.				Y					Y	10/25/2006	10/25/2006	0		PVT	PUB	Enalapril, Terazosin, Gemtibrozil, Aspirin, Multi vitamin.			ER visti neede epirephrine shot~Influenza (Seasonal) (no brand name)~~65.00~In Patient		1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0265918	11/02/2006	NJ	82.0	81		M	11/02/2006	Cellulitis like local reaction began within hours of administration.				Y					U	11/01/2006	11/01/2006	0	NONE	PVT	PVT	Zocor, Ativan, Viagra, Toprol XL, Flomax.	NONE	HTN, depression, BPH, high cholesterol, CAD.			1						1	Cellulitis; Injection site reaction	FLU3~SANOFI PASTEUR~U2204AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0882F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0265910	11/03/2006	CA	1.0			M	10/30/2006	NONE									Y	10/30/2006				OTH	UNK		Constipated				1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2175HA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265911	11/03/2006	CA	0.66	0	.7	M	10/30/2006	NONE									Y	10/30/2006				OTH	UNK						1						1	Unevaluable event	FLU3~SANOFI PASTEUR~~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265912	11/03/2006	CA	0.83	0	.8	F	10/30/2006	NONE									Y	10/30/2006				OTH	UNK		Not eating well x 4 days				1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2175HA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265933	11/03/2006	NC	9.0	9		M	10/31/2006	Two hours after administration of FluMist vaccine child had a questionable 3 min generalized seizure. Child was evaluated by EMS, taken to ER eval and released. Sleep dep EEG and appt with neuro pending.				Y					Y	10/27/2006	10/27/2006	0	CT- nl (cranial), EKG - nl, GBS - 106, pulse ox - sleep dep EEG pending	PVT	PUB	Concerta	Allergic Rhinitis	NONE			1						1	Convulsion	FLUN3~MEDIMMUNE VACCINES, INC.~500435P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0265934	11/03/2006	MI	75.0	75		F	10/30/2006	Received Flu vaccine 10-13-2006 3p left deltoid at health department, localized soreness at injection site next morning, pain started that night below injection site to elbow, pain radiated up left arm to back of neck.  Relief with heat not cold, TYLENOL at 5 no relief.  Relief with heat only, pain stayed in left arm, shoulder and neck area till 10-28-06.  Pain for 15 days.									Y	10/13/2006	10/14/2006	1	NONE	PUB	PVT	ASA daily	NONE	NONE			1						1	Neck pain; Pain; Shoulder pain	FLU3~SANOFI PASTEUR~U2168BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265935	11/03/2006	NJ	79.0	79		F	10/21/2006	Chills on 10/08/2006 - Followed by 102 temperature for 2 days, upper arm completely inflamed and painful to motion. Left with a hard lump, throbs and itches. Still have lump - throbbing and itching.										10/07/2006	10/08/2006	1		PUB	UNK		NONE	NONE			1						1	Chills; Hypokinesia; Injection site induration; Injection site inflammation; Pain; Pruritus; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA207BA~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1048P~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265936	11/03/2006	WI	71.0	71		F	11/01/2006	Right deltoid area swollen, red, painful, hot to touch, no drainage, no fever 11/01/2006.  Patient advised to use ice packs locally, increase water intake and observe, report changes 11/1/06, return if worse.										10/31/2006	11/01/2006	1		PVT	PVT		post polio, diabetes mellitus II, hypertension, degenerative joint disease, unstable angina, ventri-tachycardia	CODEINE, PENICILLIN, RED DYE			1						1	Erythema; Injection site warmth; Pain; Swelling	FLU3~SANOFI PASTEUR~U2192AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0618F~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0265937	11/03/2006	NY	50.0	50		F	10/26/2006	None stated. Arm swollen. Sore L arm.				Y					Y	10/25/2006	10/25/2006	0		PVT	PVT		NONE				1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2273AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265938	11/03/2006	NY	64.0	64		F	10/26/2006	Pt had numb arm, chills, fever 101 approx 3hr after vaccine. Sore L arm, myalgias, fever 101. Painful frequent urination.				Y					Y	10/25/2006	10/25/2006	0	UA-neg	PVT	PVT		NONE				1						1	Unevaluable event	FLU3~SANOFI PASTEUR~UZ273AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0391F~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0265939	11/03/2006	NJ	58.0	58		F	10/24/2006	Complained of itching on the left hand above thumb 1/2 hr after Flu inj. No complaint of SOB, no CP, no dyspnea, no hives, no difficulty swallowing BP 220/100. 11:15 called squad. 11:35 Taken via ambulance to hospital. Pt states, I am the AHS man and we are having a major conversion today. I am selling and buying a house.				Y					U	10/24/2006	10/24/2006	0		OTH	PVT	Atenol, Synthroid, Ativan, Glucophage		Latex			1						1	Pruritus	FLU3~SANOFI PASTEUR~U2165EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265940	11/03/2006	IL	1.55	1	.5	M	10/23/2006	Redness of left arm noted on 10/22/2006 (also 23 after vaccine), diameter at 3 cm (also swelling and pain).									Y	10/20/2006	10/22/2006	2	NONE	PVT	UNK		NONE	NONE			1						1	Erythema; Pain; Swelling	DTAP~SANOFI PASTEUR~U1369AA~4~~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2174GA~3~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265941	11/03/2006	NY	32.0	32		F	10/19/2006	Fever, weakness, pain in body, heart palpitations, vomiting and diarrhea. Fever 100 next day worst symptoms.				Y					Y	10/19/2006	10/20/2006	1		OTH	PVT						1						1	Asthenia; Diarrhoea; Pain; Palpitations; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2217AA~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265942	11/03/2006	OH	61.0	61		F	10/31/2006	Flu vaccine given 10/19 left arm became sore by evening of 10/19 sore and pain on 10/20 pt spoke doctor, he told her to to use cold. Problems developed in joints by Sat swollen knee, ankles, hands, became shaky, severe weakness and shakiness. Went to ER on 10/24 continues, Dx with tic douloureux. Still has symptoms at this time.  11/28/06 Received ER medical records which reveal patient seen 10/24/06 w/complaints of several days of left arm pain which had begun & worsened after flu shot.  On 10/24, developed severe, sharp, lancinating, electrical pain in left face & jaw.  Treated w/tegretol & trileptal. Final Dx: trigeminal neuralgia.				Y					U	10/19/2006	10/19/2006	0	None at our office LABS: WBC 5.3, All cardiac w/u was WNL.	PUB	PVT	Atenolol, Enolapril, Zetia, Cercocet, Tramadol	Back pain under control	Stenosis of spine and degenerative disc disease, HTN PMH: high cholesterol, TIA, chronic low back pain			1						1	Asthenia; Joint swelling; Pain; Tremor; Trigeminal neuralgia	FLU3~SANOFI PASTEUR~U2178AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265943	11/03/2006	MT	25.0	25		F	10/31/2006	10/25/06 9:30 pm given Fluarix within 5 minutes site started to itch, arms turned blotchy within 20 minutes had hives arms, leg, chest, back.  Face red, no swelling.  No airway problems. Throat scratchy.				Y					Y	10/25/2006	10/25/2006	0	NONE	PUB	PVT	Ortho-Norvo, Vitamins, Calcium, Vitamin C	NONE	NONE			1						1	Pruritus; Rash macular; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA216AA~1~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0265952	11/03/2006		59.0	59		M		A report was received from a healthcare professional in the USA, via a company representative on 10/26/06, concerning a 55 year old male vaccinee. The vaccinee has a significant cardiac history. No details were provided regarding the vaccinee's concomitant medications. On 10/22/06, the vaccinee was administered Fluvirin, IM. On the same day, 10/20/06, the vaccinee experienced sweating and stomach pains. He called an ambulance and was admitted to the Emergency room with Myocardial Infarction. The vaccinee is still hospitalized. The nurse does not believe the vaccinee continues to have symptoms. The nurse does not consider the symptoms to be related to the vaccine due to the vaccinee's cardiac medical history. Follow up information will be sought.					Y	0				10/20/2006	10/20/2006	0		UNK	UNK	Concomitant drugs not reported.		The vaccinee has a significant cardiac history.		CVOX200600320	1						1	Abdominal pain upper; Hyperhidrosis; Myocardial infarction	FLU3~EVANS VACCINES~71642~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0265953	11/03/2006					F		A report was received from a health care professional in the USA on 10/20/2006 concerning a female vaccinee. No other patient identifiers or details regarding the vaccinees past medical history or concomitant medications were provided. On the 10/13/06 the vaccinee received a dose of influenza vaccine (potentially Fluvirin). Later that day, the vaccinee developed severe pain in her arm and flu-like symptoms. The pain progressed and emergency medical care was summoned. The patient was eventually placed in the intensive care unit due to blood pressure instability. Outcome of the events is not yet known. Further information is requested.					Y	0			U	10/13/2006	10/13/2006	0		UNK	UNK	Concomitant drugs not reported.				CVOX200600245	1						1	Blood pressure increased; Influenza like illness; Pain	FLU3~EVANS VACCINES~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0265956	11/03/2006	IN	52.0	52		F	11/02/2006	None stated										10/30/2006	10/31/2006	1	Swelling and warmth localized redness and injection site.	PVT	UNK						1						1	Injection site erythema; Injection site oedema; Injection site warmth; Unevaluable event	FLU3~SANOFI PASTEUR~U2202AA~7+~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265957	11/03/2006	MN	65.0	65		F	11/03/2006	24 hours after immunizations pt developed 5x12cm local site reaction at Pneumovax site and fever up to 38.5 C.									U	11/01/2006	11/02/2006	1	NONE	PVT	UNK		NONE				1						1	Injection site reaction; Pyrexia	FLU3~SANOFI PASTEUR~U21675A~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0359F~3~IM~GM~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~0981F~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0265963	11/03/2006		50.0	50		F	11/03/2006	This female subject was enrolled in the prophylactic open study. On 10/23/06, she received a dose of influenza vaccine (lot # AFLUA201A, IM, LA). On 10/23/06, about 30 minutes after the 1st dose of Fluarix, this 50 year old subject developed cardiac pain, shortness of breath, and headache and was hospitalized. The pain was intermittent. Her blood pressure was 127/77 and pulse rate 75. She was put on oxygen therapy. Chest was clear. Myocardial infarction was ruled out. The subject was on no concomitant medications. The events were unresolved at the time of reporting. The investigator considered that there was a reasonable possibility that the cardiac pain, shortness of breath and headache may have been caused by influenza vaccine and that the events were possibly due to study participation.					Y	0			N	10/23/2006	10/23/2006	0		OTH	OTH					B0443822A	1						1	Chest pain; Dyspnoea; Headache	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA201A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0265975	11/03/2006	MN	33.0	33		F	11/03/2006	Patient received flu shot at 1330 on 11/5/2005 and within one-half hour developed left arm pain radiating to left hand. Pain progressed throughout afternooon and at approx 1700, she developed some shortness of breath and a closing sensation in her throat.  She presented to Emergency dept at 1817 and was given Benadryl 50 mg IM and Vicodin 5/500, 2 tabs, and heating pad to shoulder.  Chest symptoms and pain improved. She states she has no egg allergy and has received flu shots in the past without problems.				Y					Y	11/05/2005	11/05/2005	0		UNK	UNK	none	none	none			1						1	Dyspnoea; Pain; Throat tightness	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0265978	11/03/2006	CA	2.0	2	.5	F	10/22/2006	Following the vaccine(2 hrs later)the patient developed nausea, vomiting, diarrhea and lethargy.  Later that night she began to spike a fever.  The lethargy, weakness, fever, and fussiness continued to progress over a couple of weeks along with some anorexia.  On 10/18 her speech got worse and she was inable to walk with unwillingness to hold urine or stool.  11/16/06 Received medical records from hospital which reveal patient admitted 10/21/06 after 3 week history of progressive malaise, ataxia, anorexia & decreased speech after being transferred from outlying hospital.  Had developed N/V/D & fever approx 2 hours after flu shot.  Initial exam revealed irritable & lethargic patient with mild shotty lymphadenopathy.  Tx w/high dose steroids. PMH: HOP, eczema, UTI Birth Hx: c-section, 8 lbs, 3.8 oz, No complications. Family Hx: 4 yo brother w/febrile seizure.  D/C dx:  Acute disseminated encephalomyelitis, resolving./ss			Y	Y	Y	7			Y	10/03/2006	10/03/2006	0	Brain MRI showed bilateral central nervous system areas of white matter abnormalities consistent with acute disseminated encephalomyelitis. LP: negative LABS: initial hospital WBC 20.1, neurs 76%.  Another hospital: WBC 17, 400. MRI of brain showed multiple bilateral CNS white matter lesions consistent with ADEM.	UNK	UNK	None	None	Eczema, UTI at either 1 or 2 months of age. Allergies: Sulfa drugs, amoxicillin, peanuts.			1						1	Abasia; Anorexia; Asthenia; Coordination abnormal; Diarrhoea; Encephalitis; Faecal incontinence; Irritability; Lethargy; Leukocytosis; Nausea; Pyrexia; Speech disorder; Urinary incontinence; Vomiting	FLU3~SANOFI PASTEUR~U21740A~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0265980	11/03/2006	NC	43.0	43		F	11/03/2006	Approx 2 hrs after receiving flu vaccine - inside of mouth burning and stinging.  Throat hurting and feeling like something in it.  Face reddened.  Eyes turned bloodshot and discharging mucus from them.  Wheezing and vomiting.  Later, body very achy.  Went to urgent care facility - gave me antihistamine, but didn't seem to know much.  The same thing happened to me last year when I received the flu vaccine.									Y	11/02/2006	11/02/2006	0		UNK	UNK		none	none			1						1	Eye discharge; Ocular hyperaemia; Pain; Pharyngolaryngeal pain; Stomatitis; Vomiting; Wheezing	FLU3~SANOFI PASTEUR~U2717AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265981	11/03/2006	LA	61.0	61		F	11/03/2006	Soreness/pain present since post-injection. Redness, rash, 1-2 vesicles noted on 10/30/2006. Seen by doctor today, 11/03/2006, and prescribed Kenalog 0.1% cream, Lodine 400mg bid, and Ultram prn.				Y					U	10/26/2006	10/30/2006	4		UNK	UNK	Altace; Premarin; Lipitor; Levoxyl; Glucophage; Dyazide; Eotrin; Hydroxyzine	None	Non-insulin dependent diabetes mellitus; Asthma; Hypothyroidism; Hypertension. Allergies to Sulfa and Codeine.			1						1	Blister; Erythema; Injection site pain; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71641~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0743F~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0265982	11/03/2006	PA	33.0	33		F	11/03/2006	Upon receiving the shot:  pain and burning under skin from shot area to distal extremity.  Followed by numbness and heaviness immediately after.  This lasted approximately 6-8 hours (shot administered 12:30, Thursday).  Friday, localized pain and (muscular) soreness at site with no reddness.  Noticed canker sores found in mouth.  Pimple (chicken pox like) or bug bike like on my scalp and nose.  Saturday,  more of these found on my scalp, abdomnial area, and back.  Sunday, more found on my torso and proximal extremities.  Appearing more like blisters/lesions.  Monday, more found on my face, torso, buttock and proximal extremities.  Some itch and some burning sensation.  Sore throat.  Went to ER, lesions were found on the back of my throat.  Went to Dermatologist that day, biopsy done.  Given prednisone 30 mg once a day. Tuesday, more new blisters with pus filled.  Wednesday, saw Dermatologist- one was scaped for culture I believe.  Dermatologist instructed me to stop taking the prednisone.  Wednesday evening - phone call from dermatologist to confirm PLEVA(pityriasis lichenoides et varioliformis acuta/mucha haberman disease).  Treatment:  minocycline 100mg BID.				Y					N	10/27/2006	10/28/2006	1	Biopsy:  PLEVA (pityriasis lichenoides et varioliformis acuta)	UNK	UNK	multi-vitamin 500 mg vit C both taken at bedtime		Oct 3 - given Valtrex for 3 days to treat Herpes 1 on/inside nose.  Large canker sores in mouth at this time, but went away 7- 10 days during this time.  Flu shot given on the 27th of October.			1						1	Aphthous stomatitis; Blister; Hypoaesthesia; Injection site pain; Myalgia; Pruritus; Sensation of heaviness; Skin burning sensation	FLU3~SANOFI PASTEUR~U2168CA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265984	11/03/2006	MN	61.0	61		F	11/03/2006	Local swelling and redness of the injected site. Swelling extended upto back of her neck and caused pain. It improved spontaneously and today when I examined it the swelling is 10x10 cm and erythematous.									Y	11/01/2006	11/02/2006	1	Advised warm soaks and started on keflex 500mg po tid x 5days.	UNK	UNK						1						1	Erythema; Injection site erythema; Injection site swelling; Pain	FLU3~SANOFI PASTEUR~U2286AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0265985	11/03/2006	MI	91.0	91		F	11/03/2006	Approx. 30min after administration of the inactivated Influenza vaccine, resident had a swollen tounge, facial drooping, and vomiting. Garbled speech and twitching noted, son stated that speech and twitching was normal for her. VS remained WNL.  Resident was able to follow simple directions.  Son did not want resident to be sent out to the hospital for evaluation.  Advance Directives state DNR and comfort measures only.  Resident has a history of TIA's and seizures.  Resident was monitored and kept comfortable.									Y	11/02/2006	11/02/2006	0	none	UNK	UNK	Synthroid, Miacalcin, ASA, Celeza, Os-cal, Dilantin, Remeron, Tobradex, Keflex.	Was currently taking Keflex X 7 days for infected skin tear.  Keflex started on 10-31-06.	Allergy:  Darvocet.  Diagnosis:  CHF, Seizure disorder, Progressive dementia, Hypothyroidism, Osteoarthritis, HTN, MI, Hypercholestrolemia, Depression with psychotic features, Chronic kidney disease.			1						1	Facial palsy; Muscle twitching; Speech disorder; Tongue oedema; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69423~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0265991	11/03/2006	FL	30.0	30		M	11/03/2006	On Monday, October 30, the patient received a pneumococcal vaccine and over a period of 48 hours he developed a progressive swelling and extreme tenderness over the site of the injection on the left arm.  On November 2 he was seen by M.D. and patch of 7 x 8 cm of erythema and induration that on the previous day had been quite small had enlarged and spread to the medial aspect of the arm.  The patient had significant induration and the overlying skin was warm and despite the fact that the patient had been trying to use cold compress to obtain relief he was quite uncomfortable.  The patient also had a temperature that was documented to 101.5.  It should be noted that all these reactions occurred while the patient was receiving linezolid. 11/28/06 Received medical records from hospital which reveal patient admitted 10/16/-10/30/06 w/Dx: excerbation of cystic fibrosis of increased cough, production of purulent sputum, increased fatigue, renal dysfunction, vomiting/diarrhea & general malaise.  Also had lost approx 20# over past 2-3 mo.  Received IV antibiotics.  Consults by pulm & ID.  Improved significantly.  Was given flu & pneumo on day of d/c to home. D/C DX: acute exacerbation of cystic fibrosis, improved; renal insufficiency, resolved; & electrolye imbalance, treated. Patient was readmitted to hospital approx 48 hours after receiving vax w/severely swollen arm w/pain, limited mobility, fever, redness, induration & edema extending from lower deltoid to elbow.  Admitted 11/2/06 & d/c 11/5/06.  Treated with IV antibiotics.  Developed & was treated for candida.  Improved significantly & was d/c to home on continued oral antibiotics. D/C DX: severe reaction to pneumococcal vax w/cellulitis & sterile vaccine reaction; cystic fibrosis, stable; recovering from recent CF exacerbation; chronic hypokalemia & hypomagnasemia; & candidiasis. Patient was febrile on 2NOV06					Y	3			N	10/30/2006	11/02/2006	3	LABS: bronchoscopy revealed + pseudomonas & staph aureus.	UNK	UNK			PMH: cystic fibrosis w/multiple exacerbations.  Recently on multi antibiotics for prior pseudamonas infection & MRSA in sputum.  Recurrent sinusitis s/p multi sinus surgeries.  GERD. Right elbow arthritis.			1						1	Bronchoscopy abnormal; Candidiasis; Cellulitis; Condition aggravated; Cough; Cystic fibrosis lung; Diarrhoea; Electrolyte imbalance; Erythema; Fatigue; Hypokalaemia; Hypomagnesaemia; Induration; Injection site oedema; Injection site pain; Injection site pain; Injection site swelling; Malaise; Mobility decreased; Oedema peripheral; Pain in extremity; Pyrexia; Renal failure; Skin warm; Sputum purulent; Vaccination complication; Vomiting; Injection site erythema; Injection site oedema; Tenderness	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~1~SC~RA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~0001F~UNK~SC~UN~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0265993	11/03/2006	IL	0.0			M	11/03/2006	Itching, swelling, redness at injection site; arm pain; diphenhydramine given; history of penicillin allergy.				Y					Y	10/31/2006	11/02/2006	2		UNK	UNK			penicillin allergy			1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Pain; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua218ba~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0265994	11/03/2006	IL	0.0			F	11/03/2006	Arm pain; rash; itching, redness, swelling at injection site; diphenhydramine and methylprednisolone given.				Y					Y	10/25/2006	10/27/2006	2		UNK	UNK			penicillin and levofloxacin allergies			1						1	Injection site erythema; Injection site swelling; Pain; Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua218ba~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0265995	11/03/2006	IL	0.0			F	11/03/2006	Arm pain; redness, itching, swelling at injection site.									Y	10/31/2006	11/02/2006	2		UNK	UNK			penicillin and azithromycin allergies			1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Pain; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua218ba~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0265997	11/03/2006	CT	0.0	74		F	11/03/2006	Pnuemovax Injection site, right deltoid noted to be red, tender, and warm on 10/25/2006 after receiving the injection on 10/23/2006.  No fever or chills.  Went to primary care provider who prescribed Keflex.				Y					Y	10/23/2006	10/25/2006	2	NA	UNK	UNK	Zetia, Synthroid, Norvasc, Dyazide	none	Hyperlipidemia Hypertension Thyroid condition			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA221AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0352F~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0265999	11/03/2006	AZ	6.0	6		F	11/03/2006	Swelling on both arms at site of injection.  Painful.									U	11/02/2006	11/03/2006	1		UNK	UNK		None	None			1						1	Injection site swelling; Pain	DTAP~UNKNOWN MANUFACTURER~~5~IM~UN~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~3~IM~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~2~IM~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0266019	11/03/2006	KY	50.0	50		M	11/01/2006	Erythema rash, slight burning.  Treatment: gave 1 BENADRYL 25mg capsule.									Y	11/01/2006	11/01/2006	0	NONE	OTH	PVT	WELLBUTRIN, PREVACID	NONE	previous slight reactions to shots/vaccines.	rash~Influenza (Seasonal) (no brand name)~~40.00~In Patient		1						1	Rash erythematous	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71215~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266020	11/03/2006	CA	47.0	47		F	11/03/2006	10/09/2006 Possible Urinary Tract Infection-pelvic pain. 10/17/2006 Medical doctor visit pain in feet, pelvic girdle pain, rectal pain. 10/30/2006 Neurologist loss of sensation, waist down. MR received PMH: 51 year old in excellent health.  Meds: Thyroid, Prozac, Advil PRN.  Allergic to raspberries.  She had abrupt onset of perineal pain and difficulty urinating 4 days s/p flu vax.for which she was treated with antibiotics. Subsequently developed pain, allodynia on soles of feet, perineum, axillae.  No weakness noted at this time.  Treated with 2 of 6 Apheresis treatments prior to discharge from hospital. Discharge DX:  Post-vaccinial dysimmune radiculitis				Y					N	10/05/2006	10/09/2006	4	LABS and Diagnostics:  CBC, CMP, PT, PTT all normal.	PUB	UNK	Meds: Thyroid, Prozac, Advil PRN.	NONE	Allergic to raspberries.			1						1	Dysuria; Immune system disorder; Pain; Pain in extremity; Pelvic pain; Perineal pain; Proctalgia; Vaccination complication	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALFLA208BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0266021	11/03/2006	AR	28.0	28		M	11/03/2006	Developed generalized hives, but very few in number.  Initially pruritic, but this resolved with use of steroid cream (over the counter), no wheezing, no respiratory symptoms.									N	10/27/2006	11/01/2006	5		UNK	UNK		NONE	ulcerative colitis			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2213AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266001	11/04/2006	IL	61.0	61		M	11/04/2006	Possible signs of bell palsy, swelling and soreness on left side of face, droopy eye, teary eye. Sagging of left side of face. MR and received revealing a previously healthy 61 year old (no meds) who presented with left facial weakness of 2 weeks duration. Symptoms began several days after his flu shot. He also complained of hearing loss in the left ear as well as tenderness in the left mastoid region. He was intially seen by his PCP (unknown) and treated with steroids which did not improve the problem. Speech articulation was also affected.  Corneal reflex markedly decreased on the left.  Initial Assessment: Left peripheral facial weakness with decreased hearing and sensation of left face, suggesting a lesion in the brainstem/left CP angle/or menigeal lesions, or of multiple cranial nerves.   Addendum following MRI results-Flu shot neuritis									U	11/03/2006	11/04/2006	1	LABS and DIAGNOSTICS: MRI negative for any brain involvement although some enhancement of the descending portion of the left facial nerve in the temporal bone was noted, which may be secondary to facial neuritis associated with Bell's Palsy.	UNK	UNK	none	none	none noted			1						1	Corneal reflex decreased; Facial palsy; Hearing impaired; Hemiparesis; Lacrimation increased; Neuritis; Speech disorder; Swelling; Tenderness; Facial palsy; Hearing impaired	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|UNK~UNKNOWN MANUFACTURER~~UNK~~UN~VACCINE NOT SPECIFIED (NO BRAND NAME)~2	USA		Influenza
0266002	11/04/2006	WA	1.29	1	.3	M	11/04/2006	Child broke out in hives on back, stomach, face and legs a few hours after receiving a hepatitis A shot. I viewed an article online that stated children over 2 should receive this shot in 2 parts, 6 months apart. My son is only 15 months old.				Y					U	11/03/2006	11/03/2006	0		MIL	MIL		None	None			1						1	Medication error; Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~~3~IM~LL~DTAP (INFANRIX)~1|FLUX~UNKNOWN MANUFACTURER~~2~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~1~IM~RL~HEP A (NO BRAND NAME)~1|PNC~PFIZER\WYETH~~2~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0266003	11/05/2006	FL	66.0	66		F	11/05/2006	Had pneumo shot same time, same arm.  Now very red, very tender and swollen. Swelling started approx. 2 hours post shots.  General fatigue sore muscles, weak in both arms 4 hours post.  Pain so severe, that she became nauseuous 14 hours post.  Two days in bed, third day a little improvement in general fatigue.  Still swollen, very tender and red in left arm at site of shots.									N	11/02/2006	11/02/2006	0	none	UNK	UNK	hyzaar	none	Hypertension			1						1	Fatigue; Injection site erythema; Injection site pain; Injection site swelling; Muscular weakness; Myalgia; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266004	11/05/2006	CA	62.0	62		F	11/05/2006	Vaccinated 11/4/06 Saturday 10am. Symptoms at 9pm Saturday night. Hives all over body. Breathing difficult, throat tightened, hoarseness. Felt relief Sunday morning 11/5 1am.										11/04/2006	11/04/2006	0		MIL	UNK						1						1	Dysphonia; Dyspnoea; Throat tightness; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0266005	11/05/2006	NC	39.0	39		M	11/05/2006	Pt developed rash on arm, chest and back.  Pt also had severe itching and rhinorrhea.  Symptoms began = 1 hour after adminstation.  Pt was given some benedryl.  Symptoms are resolving.				Y					Y	11/05/2006	11/05/2006	0		MIL	MIL						1						1	Pruritus; Rash; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~5004431P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0266006	11/05/2006	IN	55.0	55		M	11/05/2006	Pt developed rash on legs and back about three hours after receiving influenza vaccination on 3 November 2006.									Y	11/03/2006	11/03/2006	0	none	MIL	MIL	none	none	none	rash/putstules to back, face, chest and itcing~Td Adsorbed (no brand name)~~0.00~In Patient		1						1	Rash	FLU3~SANOFI PASTEUR~42199AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266007	11/05/2006	NY	43.0	43		M	11/05/2006	Pt started having itching and redness on face, neck, axilla, flanks and hands around 11am today, reported symptoms at 1430 because it was getting worse.  Pt was given FluMist at 1100 11/4/06.  Pt denies any shortness of breath, no difficulty breathing, throat swelling.  No Stridor noted. Pt given 50 mg benadryl at 1445 PO.				Y					U	11/04/2006	11/05/2006	1		MIL	MIL	none	none	HTN, Hyperlipidemia			1						1	Erythema; Pruritus	FLUN3~MEDIMMUNE VACCINES, INC.~500438P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0266008	11/05/2006	MN	53.0	53		M	11/05/2006	10/26/2006 Flu Shot was given at 2:00pm in left arm.  5:00pm sore swollen knees, could hardly walk. Sore right shoulder also.  By 7:00pm 101 degree temp.  8:00 102.3 temp. 10/27/2006 Still stiff and sore knees and shoulder.  By afternoon, hands and knuckles also swollen.  Temp was 101 degrees.  Much difficulty walking both days. 10/28/2006  Symptoms the same. 10/29/2006  Able to walk better and use arm better.									Y	10/26/2006	10/26/2006	0	none	UNK	UNK	Lisinopril 5mg Loratadine 10 mg Naproxen Sodium 220mg Glucosamine 500mg x 3 Chondroitin 400mg x 3 Equate multi vitamin	none	none			1						1	Difficulty in walking; Joint swelling; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0266010	11/05/2006	CA	1.64	1	.6	M	11/05/2006	Fast Heart Beat, Fever, difficulty Breathing.				Y					Y	11/01/2006	11/01/2006	0		UNK	UNK						1						1	Dyspnoea; Heart rate increased; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~2~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0266011	11/05/2006	CA	2.0			M	11/05/2006	Within 30 mins. a 2 diameter, hard, red, hot, painful lump appeared at the injection site.  It was still there after several hours, so I was advised to treat my son with children's motrin.  I gave him motrin daily for 4 days at which time the lump disappeared. 10 days after the vaccination, my son developed a severe case of hives--large, raised, itchy blotches all over his body.  I treated him with Benadryl but the hives kept recurring every few hours.  After a few days of hives, I brought him to the allergist who prescribed Zyrtec and Zantac 2x a day for 1 month.  This treatment controlled the hives until my son missed 2 doses (2 weeks after the treatment was begun) and hives recurred.  The treatment was resumed and continued for the remainder of the month.  When the treatment ended the hives did not recur.				Y					Y					UNK	UNK		May have had a cold.  No fever.	egg allergy			1						1	Injection site erythema; Injection site induration; Injection site mass; Injection site pain; Injection site warmth; Rash erythematous; Rash macular; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0266012	11/06/2006	CA	60.0	60		M	11/04/2006	Patient's father came in; said patient felt ill, went to emergency room, got hospitalized for respiratory problem/infection and died day(?) shortly afterward. 11/20/06 Received medical records from hospital which indicate patient seen 10/13/06 with altered mental status, SOB, nausea, vomiting.  Seen in local clinic & dx w/HTN.  Patient coded outside ER where he had been brought by his parents.  Code/intubation were successful.  NGT revealed coffee ground gastric contents. LABS: WBC 41,800, H/H 9.3/26.3, plts 119,000.  Na 110, K5.5, BUN/creat 108/3.9, cl 76.  Troponin 0.16.  Calcium 5.7.  Beta natriuretic peptide 1570. ABG showed metabolic acidosis.  CXR revealed cardiomegaly w/pulmonary congestion consistent w/CHF & RLL pneumonia.   Patient expired 10/23/06 when he coded again while on his way to OR for trach. No autopsy was done. DX: cardiopulmonary arrest s/p successful resuscitation; Gram neg septic shock, acute renal failure; metabolic acidosis; hypocalcemia; ARDS; multi system organ failure; & UGI bleeding. 12/1/06 Received death certificate which reveals COD as acute cardiopulmonary arrest, septic shock & hypertension.	Y	10/23/2006							N	10/05/2006				OTH	PVT	NONE					1						1	Respiratory disorder; Respiratory tract infection; Infection; Malaise; Respiratory disorder	FLU3~SANOFI PASTEUR~U2240AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2240AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0266015	11/06/2006	KY	38.0	37		M	11/05/2006	Pt was given 2 pneumovax and Fluzone inj on 11/02/06 (afternoon). Pts wife called 11/02/06 in the evening to say pt had fever, vomiting and soreness. On 11/04/2006. PT had worsening of symptoms w/large areas of redness and swelling. Pt went to ER on 11/4/06 and was diagnosed with cellulitis and given antibiotic on that date.				Y					Y	11/02/2006	11/03/2006	1		OTH	PVT						1						1	Cellulitis; Injection site erythema; Injection site oedema; Pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2180AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0619F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0266018	11/06/2006	CT	3.0	3		M	11/03/2006	Pt developed Bell's palsy within hours of vaccine administration. PCP MR received revealing a 3 yr. old in for a well-child exam on Oct. 20, 2006.   PMH consists of asthma and seasonal allergies. Only c/o is of cold sx.and runny nose x 2 days. Exam reveals Right OM effusion. Flu shot given. Acute visit of 10/23/2006 for c/o Left side of face not moving.   DX: Bells Palsy (URI probable etiology).  F/U visit of 10/27/2006 reveals some improvement, child able to smile and close eyelid more./pc 11/16/2006 Hospital MR received revealing child presenting to ER on evening of flu shot with the following sx.: L side of mouth unable to smile, L eye unable to fully close, L forehead does not wrinkle with raised eyebrow, and clear watery discharge from L eye.  DIAGNOSIS: Bell's Palsy				Y					U	10/20/2006	10/20/2006	0	Lyme AB negative.	PUB	PUB		Cold sx.and runny nose x 2 days. Exam reveals Right OM effusion.	asthma and seasonal allergies			1						1	Facial palsy	FLU3~SANOFI PASTEUR~U2275AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266047	11/06/2006	TX	6.0	6		F	11/03/2006	Pt received Varicella and Influenza vaccine at 2:00pm within 15-30 mins, pt developed facial angioedema (lips, eyelids), difficulty breathing, facial flushing, hypoxemia and drooling. Pt started on O2 by nasal cannule, given epinephrine 0.15mg IM and Diphenhydramine 55 mg PO X 7. 01/12/07-records received and reviewed.  DC DX: Allergic reaction. Treated overnight  in ER temp 98.9,  Eyelid, tongue swelling with pruitis and SOB. Treated with Solu-Medrol and Benadryl				Y	Y	1			Y	10/31/2006	10/31/2006	0		PVT	PUB	Lasix, Metroprolol, Enalapril, ASA, amoxicillin.		Heterotaxy syndrome, congenital heart disease, asplenia PMH: Status post pacemaker insertion.			1						1	Angioneurotic oedema; Drooling; Eyelid oedema; Flushing; Hypoxia	FLU3~SANOFI PASTEUR~U2245AA~7+~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0905F~2~SC~RL~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0266049	11/06/2006	NY	70.0	70		F	10/27/2006	I became so very dizzy that I had to drop to the knees, I shut my eyes.  I became very sick to my stomach and being I couldn't reach the bathroom, I grabbed onto a couch and threw up and then I lost control of my bowels. 11/15/06-spoke with reporter, did not see a physician until 11/3/06. She erred in marking life threatening illness. krk  Patient seen only 1 time by Dr. on 11/14/2006. 12/5/06-Impression: right sided endolymphatic hydrops. Asymmetric sensorineural hearing loss. Recommendations: MRI, viral titers and ENG.  History of fall on right side of face in May 2003, June 25, 2004 during airplant flight her right ear closed up to the point of difficulty hearing with sporadic fluctuations in her hearing, vertigo summer of 2005, in summer of 2005 diagnosed with Meniere's disease after ENG, EcoG testing. January or February 2006 second bout of brief spontaneous vertigo. June 5, 2006 second fall again without dizziness while doing aerobics. Broker her left wrist. September 2006 blisters showed up for about 10 days on her right buttocks. Reported to be herpes type virus. Changed from Lipitor to Zocor on October 18, 2006, subsequently stopped Zocor due to Flu shot on October 21, 2006 and within 2 hours she was vertiginous as spinning. Experienced nausea, vomiting and loss of bowels with diaphoresis. Denies change in aural fullness or hearing. Duration 2 1/2 hours. November 1st and 5th 2006 had 2nd and 3rd debilitating spellings. Placed on Antivert on November 2, 2006 by ENT.				Y					Y	10/21/2006	10/21/2006	0		OTH	OTH	Advair, Flonase, Bactroban, Norvasc, Triam HTZ, Gabapentin, Crestor, Ecotrin, Actonel.		asthma, hypertension, Menieres disease, pinched nerve, disc C4-C5 giving me trouble, high cholesterol, low bone density, 2 strokes.			1						1	Dizziness; Faecal incontinence; Hypoacusis; Meniere's disease; Vomiting	FLUX~UNKNOWN MANUFACTURER~~3~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0266050	11/06/2006	AL	68.0	68		F	11/01/2006	Fever up to 105.2, chills, right shoulder pain, body aches, hypotension, pt admitted to medical center to ICU. 11/14/06-DC DX: Reaction to Pneumovax. Hypertension. Rheumatoid arthritis. Iron deficiency anemia. Hypothyroidism. Fevers up to 105 prior to admission.					Y	1			Y	10/31/2006	10/31/2006	0	Blood cultures negative. WBC 9.2. UA clear	PVT	PVT	Actonel, Tandem, Celebrex, Levoxyl, Prednisone.		Med allergies Codeine, Hydrocodone, Cipro, medical conditions: hypertension, PVD, rheumatoid arthritis, anemia , iron deficiency, hypothyrodisim.			1						1	Blood culture negative; Chills; Hypotension; Pain; Pyrexia; Rheumatoid arthritis; Shoulder pain; Urine analysis normal; White blood cell count normal	FLUX~UNKNOWN MANUFACTURER~12F69511~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0619F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0266057	11/06/2006	IL	10.0	9		F	11/06/2006	Two events within 24 hours after vaccine given. Pt saw blue spots in eyes for 15-20 minutes vomited 1x after 1st episode.									Y	10/24/2006	10/25/2006	1		PVT	OTH						1						1	Visual disturbance; Vomiting	FLU3~SANOFI PASTEUR~U2257AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266058	11/06/2006	TX	55.0	55		F	11/03/2006	Facial skin irritation.									Y	10/31/2006	10/31/2006	0		PVT	PVT	Singulair, Albuterol inhaler, Advair		Hypertension.			1						1	Skin irritation	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601511~UNK~~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0266059	11/06/2006	TX	65.0	64		F	11/03/2006	Profuse Sweating, shakiness, nausea, stomach cramping, weak feeling.									Y	11/01/2006	11/01/2006	0		PVT	PVT						1						1	Abdominal pain; Asthenia; Hyperhidrosis; Nausea; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601511~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0266060	11/06/2006	VA	64.0	64		F	11/01/2006	Inj of flu vaccine with incident 10/21/2006 left arm noted blister at injection site, 1/2 inch blister reddened border, mildly inflamed non tender no discomfort, swelling or fever.									Y	10/21/2006	10/26/2006	5		PUB	PUB			Mild HBP, mild Lipidemia.		VA06029	1						1	Injection site erythema; Injection site inflammation; Injection site vesicles	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA210AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0266063	11/06/2006	TX	23.0	22		F	10/20/2006	SOB at 1500 seen by provider given Benadryl 25g PO, SXS resolved.				Y					Y	10/20/2006	10/20/2006	0	O2 sat at 1630 96% with pulse 66.	PUB	PVT	Codeine	Sharp pain left eye			TX06073	1						1	Dyspnoea	FLU3~SANOFI PASTEUR~U2212AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266064	11/06/2006	TX	7.0	6		F	11/03/2006	Indurated, erythema sore arm, circumferential with fever.									Y	11/01/2006	11/02/2006	1		PVT	UNK		Mild URI	H/O asthma, allergies.			1						1	Injection site erythema; Injection site induration; Injection site pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266065	11/06/2006	WI	65.0	64		F	10/27/2006	Vaccine given in right arm, Arm swelled up, got very hot. Severe pain in arm, shoulder, and, neck. Got red blotches 3-4 inches in diameter on arm, shoulder, and neck. Fever of 102.7 or 102.9 for 3 days. Headache, nausea, and vomiting.									Y	10/16/2006	10/16/2006	0		PUB	PVT	Lipitor, Trazodone.		Penicillin			1						1	Headache; Injection site oedema; Injection site pain; Injection site warmth; Nausea; Pyrexia; Rash macular; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266066	11/06/2006	KY	73.0	72		F	10/31/2006	Pt received flu vaccine on 10/20/06. Reports having Flu like symptoms on 10/23/06. Pt states having chills, fever (but did not take temp). Headache and heart racing. Pt reports having a little congestion the day she got her shot but did not say anything. Pt states she has not gone to the doctor but will call him today because she cannot get rid of the cough. Pt states she will never get another flu shot.										10/20/2006	10/23/2006	3		OTH	PUB		Pt now reports she was a little congested.				1						1	Chills; Cough; Headache; Heart rate increased; Influenza like illness; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F60104~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0266067	11/06/2006	MN	73.0	73		M	10/30/2006	Pneumovax booster triggered generalized swelling and intense itching, Prednisone PO and clinic exam only.									U	10/27/2006	10/28/2006	1	Examined	PUB	PVT			Allergies, codien, sulfa, Aleve, Ibuprofen, Fedine.			1						1	Oedema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266068	11/06/2006	UT	55.0	55		F	10/24/2006	Left side of tongue went numb Saturday and is still numb today. Monday has effected taste. Received vaccine (flu) Thursday the 19. Given in the right arm.									N	10/19/2006	10/21/2006	2	NONE	PUB	OTH						1						1	Dysgeusia; Hypoaesthesia; Tongue disorder	FLU3~SANOFI PASTEUR~U2177AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266070	11/06/2006	SC	66.0	65		F	10/27/2006	Morning after vaccine very dizzy, almost past out. Blood pressure high. Dizzy all day nausea, dizzy, light headed continued Tues, Wed, Thurs, Fri, Still not completely gone.				Y					U	10/22/2006	10/23/2006	1	Blood pressure levels higher than normal	UNK	OTH	NONE	NONE	NONE			1						1	Dizziness; Hypertension; Nausea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70740~UNK~~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0266071	11/06/2006	NY	76.0	76		F	10/27/2006	Pt had pain, swelling, and redness at site. Tylenol, Benadryl and ice.									Y	10/23/2006	10/23/2006	0	Neg	PVT	PVT			HCTZ, sun tan lotion			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71211~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0486~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266072	11/06/2006	WI	51.0	51		F	10/20/2006	Pain shoulder to mid fore arm slight swelling.				Y					Y	10/19/2006	10/20/2006	1		MIL	UNK	ASA		NONE			1						1	Injection site oedema; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA211BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0266076	11/06/2006	NM	50.0	50		F	10/28/2006	Swelling and pain and hardness of right arm. Swelling is travelling down arm. there is a definite demarcation of swelling. Ibuprofen for swelling and pain. Pt reports no fever, chills or other SX.									U	10/26/2006	10/27/2006	1		OTH	PVT	Amour Thyroid, Advil cold Sinus, Biest HRT, Advil	Cold and Sinus condition	Sulfa, is sensitive to percocet.			1						1	Injection site induration; Injection site oedema; Injection site pain; Oedema	FLU3~SANOFI PASTEUR~U2240AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1036D~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266078	11/06/2006	NH	41.0	41		F	10/27/2006	Large local reaction with cellulitis. Treated with antibiotic prescribed from Emergency Room visit. Flu shot admin. 10/20/06, pt called office to inform of ER visit - pt called 10/23/06, we seen her immediately. Referred to clinic - pt did not return.				Y					Y	10/20/2006	10/20/2006	0	ER sent pt for CBC differential - blood culture - all returned within normal limits.	PVT	PVT		NONE	Hives - unspecified			1						1	Cellulitis; Injection site reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70737~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0266079	11/06/2006	KY	16.0	15		M	10/27/2006	Per patient: few minutes after receiving flu injection of 0.5 cc sneezing and runny nose for 15-20 minutes, arrived at home, laid down, eyes became puffy, hives all over body, throat became sore and appeared swollen., Went to hospital emergency room.				Y					Y	10/26/2006	10/26/2006	0	NONE	PVT	UNK	Advair in wintertime	NONE				1						1	Eye swelling; Pharyngeal oedema; Pharyngolaryngeal pain; Rhinorrhoea; Sneezing; Urticaria	FLU3~SANOFI PASTEUR~U2245AA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266080	11/06/2006	MI	37.0	37		F	10/26/2006	Localized swelling, redness and heat. Swelling area measured 7cm x 8cm. Swelling started 90 mins after injection and continued for 18 hours. Histamine headache that started 24 hours after shot and continued for 11 days.				Y					Y	10/12/2006	10/12/2006	0	NONE	PVT	PVT	Advair, Singulair, Atrovent, Fosamax,.	NONE	Asthma	~Tetanus Toxoid (no brand name)~~10.00~In Patient		1						1	Cluster headache; Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U2195AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266081	11/06/2006	VA	32.0	32		M	10/27/2006	Erythematous, papular rash, confluent in some regions located to upper ext, head and neck. Blanch able non pruritic. Tx with 24 hour with Benadryl 50 mg Q 6 hours with relief. Trial of Prednisone 60 mg QD x 5 days.									Y	10/24/2006	10/26/2006	2		MIL	MIL	NONE	NONE	NONE			1						1	Erythema; Rash papular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA219BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|TYP~SANOFI PASTEUR~Z0276~7+~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0266084	11/06/2006	FL	60.0	60		M	11/01/2006	Pt left after vaccine without s/s adverse reaction, received phone call after leaving work that pt had returned to office with C/O dizziness, labored breathing and pressure like feeling over right eye.									Y	10/31/2006	10/31/2006	0		UNK	PVT	Toprol, Folic acid, Norvasc, Ecotrin, Plavix, Vytorin.	NONE	Cardiovascular disease, Hypertension.			1						1	Dizziness; Dyspnoea; Eye disorder; Sensation of pressure	FLU3~SANOFI PASTEUR~U2244AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266108	11/06/2006	MA	24.0	24		M	11/06/2006	RECEIVED MULTIPLE VACCINATION REQUIRED FOR DEPLOYMENT. ON 21 OCTOBER AT ABOUT 1500 HOURS, RECEIVED HEPATITIS A/B (TWINRIX), Tdap (ADACEL), TYPHOID, YELLOW FEVER IN LT DELTOID ALL WITHIN 1 CIRCUMFERENCE FROM EACH OTHER. IN HIS RT DELTOID HE RECEIVED INFLUENZA VACCINE. MEMBER AWOKE AT ABOUT 0300 ON 22 OCTOBER (ABOUT 12 HOURS LATER)WITH LT ARM PAIN RADIATING DOWN ARM AND UP NECK AND WAS GIVEN TORDAL IM. SUBSEQUENTLY DEVELOPED RASH SPREADING FROM SITE OF IMMUNIZATIONS INJECTION TO FACE, CHEST AND GROIN THRU 24 OCTOBER. TREATED 24 OCTOBER WITH PREDNISONE, RANITIDINE, AND DIPHENHYDRAMINE WITH COMPLETE RESOLUTION BY 30 OCTOBER.				Y					Y	10/21/2006	10/22/2006	1	PREVIOUS Td WAS 1996 PER PT H(X).	MIL	MIL	none	none	NONE			1						1	Injection site rash; Neck pain; Pain	FLU3~SANOFI PASTEUR~U2199AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB030BA~2~IM~LA~HEP A + HEP B (TWINRIX)~1|TDAP~SANOFI PASTEUR~~1~IM~LA~TDAP (ADACEL)~1|TYP~SANOFI PASTEUR~Z0122AV~1~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|YF~SANOFI PASTEUR~UE896AA~1~IM~LA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0266109	11/06/2006	FL	15.0	15		M	11/06/2006	About 1 hour after receiving the vaccines the clinet returned with his parent. He had swelling and redness in the right arm and complained of severe pain at injection site.									U	11/03/2006	11/03/2006	0		UNK	UNK	Unkown	None	Cerebral Palsy.			1						1	Erythema; Injection site pain; Swelling	FLU3~SANOFI PASTEUR~U2244AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0618F~1~ID~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266111	11/06/2006	MN	27.0	27		F	11/06/2006	Within 4 hours of the vaccination, I woke up with severe muscle soreness in the R deltoid that was partially relieved with ibuprofen and improved the next day. 3 days later, the pain recurred and has worsened, originating in my upper arm/shoulder and shooting into my scapula and jaw, as well as down my forearm into my fingers. It is constant, deep, and feels like a knife is stuck in my humerus. I have been taking ibuprofen round-the-clock, and am icing it several times a day. This is perhaps the most severe pain I have ever had and I am unable to sleep more than an hour or two at a time. I am seeing a physician this afternoon.				Y					U	10/30/2006	10/30/2006	0		UNK	UNK	CellCept 500 mg po bid Ortho TriCyclen Lo (28 day cycle) Multivitamin	None	Dermatomyositis, seasonal allergies			1						1	Myalgia; Pain; Pain in jaw; Sleep disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~alfua208ba~3~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|TDAP~SANOFI PASTEUR~c2609aa~7+~IM~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0266112	11/06/2006	KY	54.0	54		F	11/06/2006	I am an RN in a pediatric practice and take the Influenza Vaccine yearly.  Approximately 32 hours after receiving the Influenza Vaccine, I had severe vomiting and fever of 102 degrees.  I used Phenergan and Tylenol for symptoms.  These same adverse symptoms have been reported verbally to me by several other people in the community after they had received the Influenza vaccine in less than a 48 hour period.									Y	10/31/2006	11/01/2006	1	none	UNK	UNK	Advair, Singulair, Altace	None	None			1						1	Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2245AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266113	11/06/2006	PA	54.0	54		F	11/06/2006	Flu like symptoms.  Tired, swelling, redness, hot, sore arm and muscle.  Place warm clothes.				Y					Y	11/03/2006	11/03/2006	0		UNK	UNK	Tyleon Arthritis 650MG Voltarin 30mg Cymbalta 30mg	none	Sulpha, Floxin, Iodine			1						1	Fatigue; Influenza like illness; Injection site erythema; Injection site swelling; Injection site warmth; Myalgia; Pain	FLU3~SANOFI PASTEUR~U2254AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266114	11/06/2006	TX	35.0	35		M	11/06/2006	Increased blood pressure (Machine 140/90; Manual 165/138) and HA.  Sent to ER for treatment.  AT ER:  EKG, CAT scan, meds given (3 Tylenol, 3 nitro, 50 mg Metoprolol. 12/8/06 Received medical records from hospital which reveal patient experienced pounding headache while at dentist. BP check revealed significant hypertension & was sent to ER for evaluation.  BP in ER was 165/138 & HA was 7/10 since vax earlier on same day.  Treated w/antihypertensives & NTG in ER with good relief & was released to care of PCP.  Final Dx: hypertension.				Y					Y	11/04/2006	11/04/2006	0	LABS: CT of brain was WNL.	MIL	MIL	unknown	none	untreated hypertension PMH: untreated hypertension			1						1	Blood pressure increased; Headache	FLUN3~MEDIMMUNE VACCINES, INC.~500431P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0266115	11/06/2006	TX	55.0	55		M	11/06/2006	Flu-like symptoms accompanied with diarrhea.									Y	11/03/2006				MIL	MIL	unknown	none	unknown	flu symptoms/diarrhea~Influenza (Seasonal) (no brand name)~~0.00~Patient		1						1	Diarrhoea; Influenza like illness	FLU3~SANOFI PASTEUR~U2286AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~SANOFI PASTEUR~Z0425~5~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0266118	11/06/2006	NY	3.0	3		M	11/06/2006	Spots all over face noticed next morning (vaccine was give 6pm Thursday.  Effects noticed Friday morning). Left eye swelled up. Gave him Benadryl next day after calling doctor.  Spots diminished and are slowly disappearing.									Y	10/12/2006	10/13/2006	1	NONE	UNK	UNK	Pulmicort .25 daily	none	asthma			1						1	Eye swelling; Rash maculo-papular	FLUX~UNKNOWN MANUFACTURER~~1~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0266119	11/06/2006	WI	46.0	46		F	11/06/2006	PATIENT STATES THAT WITHIN 2 HOURS OF RECEIVING THE FLU VACCINE SHE LOST HER VOICE OR WAS HOARSE.  FELT LIKE THERE WAS FLUID IN LUNGS, COUGH, FELT LIKE SHE WAS WHEEZING.  SYMPTOMS LASTED FOR A COUPLE OF HOURS. BREATHING WAS OK. HOARSE UNTIL NEXT DAY.									Y	11/02/2006	11/02/2006	0		UNK	UNK	ENPRESSE 28	NONE	PSORIASIS, HEMATURIA			1						1	Cough; Dysphonia; Wheezing	FLU3~SANOFI PASTEUR~U2167MA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266120	11/06/2006	PA	52.0	52		F	11/06/2006	According to patient, at 4 pm began to feel woozy and tired.  By 6:30 pm states she just felt out of it and laid down on the couch.  At 8 pm she states that she got up to go to the bathroom and literally fell over because she was dizzy. She then took Benedryl 25mg by mouth and went to bed.  States that all night she just continued to feel dizzy and confused.  The next morning she was tired and couldn't get out of bed because she just didn't feel like she could wake up.  At that time she did notice that her arm was red and warm in a 2 inch circle around the injection site.  This area remained red and warm for the next 5 days.  There is still a slight discoloration to the area according to the patient.  The feelings of fatigue and dizziness resolved on their own.  This patient states she has had flu shots in the past without any reactions.									Y	10/13/2006	10/13/2006	0	none done	UNK	UNK	Routinely takes effexor XR, Zocor, Byetta, benecar,topromax, glucophage and ibuprofen	none	diabetes			1						1	Confusional state; Dizziness; Fall; Fatigue; Injection site erythema; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69480~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266123	11/06/2006	NC	34.0	34		F	11/06/2006	Large localized reaction developed within 24 hours with pain, erythema, induration, gradually getting worse over the next 48 hrs to included numbness and tingling in arm that was injected with Tdap. OTC Ibuprofen and cold compresses to injection site recommended.									Y	10/31/2006	11/01/2006	1	n/a	MIL	MIL	MVI	none	none			1						1	Hypoaesthesia; Injection site erythema; Injection site induration; Injection site pain; Injection site reaction; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TDAP~SANOFI PASTEUR~C2559AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0266124	11/06/2006	NC	27.0	27		F	11/06/2006	Large localized reaction in R arm with pain, swelling, erythema and induration that started within a few hours of receiving the shot. Gradually worsened over the next 48 hrs and developed some numbness and tingling in arm that was vaccinated with Tdap.  OTC Ibuprofen and cold compresses were recommended for pain relief.  Discussed with pt s/s of systemic allergic reaction and need to seek emergent care should they develop.									Y	10/31/2006	10/31/2006	0	n/a	MIL	MIL	NONE	NONE	NONE			1						1	Hypoaesthesia; Injection site erythema; Injection site induration; Injection site pain; Injection site reaction; Injection site swelling; Paraesthesia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TDAP~SANOFI PASTEUR~C2559AA~1~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0266125	11/06/2006	VA	54.0			F	11/06/2006	Approximately 27 hours after the shot patient developed splotchy face, continued over the next few hours to develop into redness and itching over entire face.  Went to bed, then woke in the morning with eyes swollen shut due to swelling.				Y					Y	10/28/2006	10/29/2006	1		UNK	UNK	unknown	None	None			1						1	Erythema; Eye swelling; Pruritus; Rash maculo-papular	FLU3~SANOFI PASTEUR~U22133A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266127	11/06/2006	NE	55.0	55		F	11/06/2006	Patient experienced fever (~100 F) and hives/rash on arms and legs. She is not allergic to any medications or food products (eggs, milk). She has never recieved the flu and Pneumo vaccines in the past. Pt was instructed to take Acetaminophen and Diphenhydramine for the reaction. Patient called back the next day (11/5/06 ~10AM) and said that she was doing significantly better.									Y	11/03/2006	11/05/2006	2		UNK	UNK		None.	None.			1						1	Pyrexia; Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~69424~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0486F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266128	11/06/2006	NC	34.0	34		F	11/06/2006	Experienced large local reaction after vaccination with Tdap on 10/31/06. Begin to have pain in arm same night on day she received the vaccine, that gradually worsened with pain, swelling, erythema and induration. Recommended OTC Ibuprofen and cold compresses to injection site for pain relief.  Reviewed systemic allergic s/s that would require emergent medical attention.									Y	10/31/2006	10/31/2006	0	na	MIL	MIL	none	none	none			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U22896AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2559AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0266129	11/06/2006	MS	35.0	30		F	11/06/2006	Flu vaccine administered @ 10 a.m. At 1:20 p.m. patient presented @ flu clinic c/o swelling of eyes, face,hands and eye tearing. Shortly started complaining of throat tightness. Resp 22; B/P 120/78; MD Assessment by Dr.; Epi .4mg give  sugq per RN. Benadryl 50 mgm IM.				Y					Y	11/06/2006	11/06/2006	0	None	UNK	UNK	?B/P Med	None reported	Hx allergy to soy products		MS06012	1						1	Eye swelling; Lacrimation increased; Oedema peripheral; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua215aa~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0266130	11/06/2006	MO	54.0	54		F	11/06/2006	Employee received vaccine on 10/27/06 after having a bone scan with contrast.  She reports becoming extremely ill 3 hours after administration of the vaccine.  Began vomiting and was examined in ED--received IV fluids and Magnesium.  Her PCP examined employee and states the illness may have been caused by the Influenza vaccine.				Y					Y	10/27/2006	10/27/2006	0	***Several employees and community members have had gastroenteritis**** Unrelated to the Influenza vaccine	MIL	OTH	Unknown	none	breast cancer			1						1	Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA204BA~3~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0266131	11/06/2006	CA	59.0	60		F	11/06/2006	Pt came into the office 2 days later, with reddness, swelling, and a very painful arm, not feeling good.  Pt was given Vicodin and taken off work for 2 days.									Y	10/28/2006	10/30/2006	2		UNK	UNK						1						1	Erythema; Malaise; Pain; Swelling; Erythema; Pain; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71356~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0619f~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71356~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~0619f~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0266131	11/06/2006	CA	61.0	60		F	11/06/2006	Patient came into office 2 days later, with redness, swelling and a very painful arm, not feeling good. Patient was given Vicoden and taken off work for 2 days.									Y	10/28/2006	10/30/2006	2		PVT	PVT						1						2	Erythema; Malaise; Pain; Swelling; Erythema; Pain; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71356~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0619f~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71356~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~0619f~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0266133	11/06/2006	OR	29.0	29		F	11/06/2006	Had flu vaccine 11/2 at 13:00.  By 14:00 had throat tightening and shweezing.  Took Benadryl 25mg and by 14:30 had tongue and lip swelling.  Co-workers recommended she go to the ED for Epi but she went home and continued Benadryl every 3 hours.  Had temt of 101.3 during the night, gone by morning of 11/3.  At report on 11/3 had no respiratory symptoms but lips and tongue still swollen.  Reports that recent tetanus booster made arm very swollen as well.  Not sure if this vaccine was right or left arm - guessed left.									Y	11/02/2006	11/02/2006	0		UNK	UNK						1						1	Face oedema; Throat tightness; Tongue oedema; Wheezing	FLU3~SANOFI PASTEUR~U2193AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266135	11/06/2006	WI	66.0	66		F	11/06/2006	Twelve hours after IM injection in LD with 0.5cc Pneumovax, Lot 485F soreness at injection site noted.  By 24 hours after injection, the UNDERSIDE of left arm from elbow to axilla was sore, red, warm, and swollen. Saw MD  around 2PM on Sat, 11/04/06; was started on Keflex. Returned to clinic Monday 11/06/2006. Area was larger, but less redness. Using Keflex, anti-inflammatories, elevation, and heat to area.				Y					Y	11/03/2006	11/04/2006	1		UNK	UNK						1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2246AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0485F~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0266136	11/06/2006	AK	39.0	39		F	11/06/2006	Presented to the ER 30 minutes after Flu injection with localized irritation.  Right side of upper arm, proximal forearm, shoulder and back all red itchy.  No shortness of breath, wheezing or difficulty swallowing.				Y					Y	10/26/2006	10/26/2006	0	Diagnosis - hypersensitivity reaction to flu vaccine.	UNK	UNK					AK200669	1						1	Hypersensitivity; Skin irritation	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA215AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0266137	11/06/2006	IL	41.0	41		F	11/06/2006	Patient noted that after 20-30 minutes after getting vaccine her face was flushed, and had chest itchiness. She felt lightheaded, nausea, and heart palpitations and dry mouth. Sent to ER and given 50 MD of Benadryl and symptoms slowly subsided.				Y					Y	10/25/2006	10/25/2006	0		UNK	UNK						1						1	Dizziness; Dry mouth; Flushing; Nausea; Palpitations; Pruritus	FLU3~SANOFI PASTEUR~U2202AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266138	11/06/2006	WA	50.0	50		F	11/06/2006	16 hrs after vaccination, bilateral forearm and hand pain. 24hrs after vaccination; left sided facial asymetry and sole of left foot was itchy.  MR received documenting an ER admit for c/o new onset bilateral arm pain with difficulty in moving her hands, and dysthesias of both arms.  She was also noted to have a left-sided facial droop. Pt. was admitted to R/O stroke.  PE: WNL except slightly slurred speech, decreased sensation to light touch in the V2 distribution bilaterally.  Left facial droop with forehead sparing.  To follow up for facial droop in 1-2 weeks. No discharge dx. reported on D/C Summary. F/U report received from 11/02/2006 which notes improvement of all symptoms with the exception of a remaining slight facial droop. Assessment:  Left facial droop c/w central lesion (involving only lower 2/3rds). + risk factors for CVA of HTN, but this is well-controlled.  DDX would be small CVA not yet detected on CT & MR vs vasculitis.				Y	Y	1			Y	10/25/2006	10/26/2006	1	Labs and Diagnostics: CT of head-no abnormalities, no hemorrhage.  MRI brain-no acute stroke, No other findings to explain the patient's symptoms.  Labs: unremarkable.	UNK	UNK	Meds: Nifedipine, Atenolol, HCTZ, and MVIs.		PMH: Obstructive Sleep Apnea, HTN.  Allergies:  PCN, sulfa (which caused a similar reaction).			1						1	Facial palsy; Pain; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA211AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0266139	11/06/2006	AK	49.0	49		F	11/06/2006	Right deltoid had redness after double dose of Flu vaccine given - no treatment needed.									Y	10/18/2006	10/18/2006	0		UNK	UNK					AK200673	1						1	Erythema; Medication error	FLU3~SANOFI PASTEUR~U2237AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266140	11/06/2006	AK	25.0	25		F	11/06/2006	Tender, red and raised localized reaction to left deltoid after flu vaccine given.									Y	10/16/2006	10/16/2006	0		UNK	UNK					AK200674	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2237AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266142	11/06/2006	PA	69.0	69		M	11/06/2006	A raised red swollen lesion 2 inch by 2 inch at the site of injection of Flu vaccination in the left arm which is sore to the touch and itches.									U	11/04/2006	11/05/2006	1		UNK	UNK	no					1						1	Injection site erythema; Injection site hypersensitivity; Injection site pain; Injection site swelling; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~123~1~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266144	11/06/2006	MO	11.0	10		F	11/04/2006	Pt developed chest tightness, Hives within 10 min of flu vaccine (Fluzone(. Given Epi Pen and transported to ER per paramedics in satisfactory condition.				Y					U	11/04/2006	11/04/2006	0	To ER	OTH	PVT	NONE	NONE	NONE			1						1	Chest discomfort; Urticaria	FLU3~SANOFI PASTEUR~U2250AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266145	11/06/2006	NC	61.0	60		F	11/06/2006	Started itching all over, started on the way home from receiving flu vaccine. No rash, no hives, no itchy throat, no breathing problems. Lasted through the night. Fine the next day reported to health dept by client on 11/03/06.									Y	10/31/2006	10/31/2006	0		PUB	PVT	Guafaline, Diavan HCT, Benadryl,  albuterol.	NONE	HBP, Chronic asthma, Seasonal allergies, PCN, ASA, Sulfa, Pain Med.			1						1	Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71354~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266146	11/06/2006	CO	23.0	23		F	11/06/2006	Vaccine injected 8:52 am. Client returned at 9:13 saying she felt dizzy, light headed, if she closed her eyes she would pass out. 9:15 B/P 154/100, P 129, 9:20 126/78 P 124. 9:47 143/103 P 100, no change. Mothers MD office called client refused, 911 called client taken to ER.				Y					U	11/06/2006	11/06/2006	0		PUB	OTH						1						1	Dizziness; Hypertension; Loss of consciousness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71647~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0266143	11/07/2006	ND	0.82	0	.8	M	10/31/2006	2 days after injection in right thigh a rash (bumpy) appeared on right thigh front and back. Without fever, without swelling. No adverse effect on mobility.									Y	10/25/2006	10/27/2006	2		OTH	PUB	None	None	None			1						1	Rash	FLU3~SANOFI PASTEUR~U2174DA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266162	11/07/2006	FL	6.0	6		M		24 HR after shot, severe headache, fever, 8 days later he fell into a coma non responsive. DC DX: encephalitis. Follow up with neurologist 7/16/06-combination of childhood migraine and medication reboudn headache phenomenon.  and on 10/17/06- symptoms of ADD.			Y	Y	Y	5			Y	11/26/2005	11/28/2005	2	EEG: occasional sharp waves. CBC normal CRP less than 0.7 CSF: WBC 8, 1000 RBC, sugar 85, protein 30. Culutures negative MRI of brain on 12/8/05: showed multiple gray and white matter abnormal matter changes consistent with encephalitis versus venous CVA. MRV of brain normal.	PVT	UNK			Tubes in ears and his adenoids removed.			1						1	Coma; Encephalitis; Headache; Laboratory test abnormal; Pyrexia	FLU3~SANOFI PASTEUR~61753AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0266163	11/07/2006	IN	55.0	55		F	11/06/2006	Shot 11/3/06 fever 103 11/4/ PM, 11/6 PM 104. Redness of site 11/5, worsening 11/7/06									Y	11/03/2006	11/04/2006	1	None	PVT	PVT		None	Sulfa allergy			1						1	Erythema; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA223AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0320F~1~~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2609AA~1~~RA~TDAP (ADACEL)~1	USA		Influenza
0266165	11/07/2006	MD	9.0	8		F		10/31/06 complained of bouts of dizziness and head hurting to mother.  11/3/06 Mother called to report.									U	10/30/2006	10/31/2006	1	None	OTH	PUB	NONE	NONE	NONE			1						1	Dizziness; Headache	FLUN3~MEDIMMUNE VACCINES, INC.~500438~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0266166	11/07/2006	FL	56.0	56		F	11/06/2006	complained of redness, warmth, discomfort at left site on 10/25/06 3PM. On 10/28/06 complained of pruitis at waist, abdomen, posterior thighs. Complained of flat red blotched on neck, shoulder and groin, leg,and swelling in hands. Went to UCC on 10/29/06 at 12 PM and was treated with SoluMedrol, Prednisone times 1 week. Complained of trace hoarseness and clearing of throat. Recovered not until 11/7/06.				Y					Y	10/25/2006	10/25/2006	0	N/A Patient visited Employee Health on 11/1/06 to report reaction.	OTH	UNK	Famotaine, actos, prednisone lipitor	N/A	Hyperlipademia, sugar intolerance			1						1	Erythema; Feeling hot; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLIA221BA~2~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0266167	11/07/2006	TX	52.0	51		F	11/06/2006	Swollen, red, hot, tender, itching. Benadryl, ice pack, heat, topical Benadryl Tylenol.									Y	11/03/2006	11/03/2006	0		OTH	OTH						1						1	Erythema; Feeling hot; Pruritus; Tenderness	FLU3~SANOFI PASTEUR~U2245AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2454AA~1~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0266168	11/07/2006	MI	45.0	44		F	11/02/2006	Left upper arm local reaction. Swelling of 7x8 cm, itching. On Benadryl and Cephalaxin 500 mg.										10/03/2006	11/01/2006	29	Induration measurement 7x8 cm.	PVT	PVT		Eustachian tube dysfunction	Penicillin, chronic bronchitis, COPD			1						1	Induration; Local reaction; Swelling	FLU3~SANOFI PASTEUR~U2178AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266171	11/07/2006	IL	8.0	7		M	11/02/2006	Redness on left arm, a 6lx 1cm, pruritus. (Noted 3 days after vaccine administered).									Y	10/26/2006	10/29/2006	3		PVT	UNK						1						1	Injection site erythema; Pruritus	FLU3~SANOFI PASTEUR~U2257AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0036F~1~~LA~HEP A (VAQTA)~1	USA		Influenza
0266180	11/07/2006	MN	36.0	36		F	11/07/2006	11/5/06 Swelling/warmth of hands bilaterally.  11/6/06 Swelling, erythema, pruritis of hands and feet bilaterally, no rash or blisters. 11/7/06 Patient presents with above symptoms to clinic.  Advised Benadryl 50 mg every 6 hours.									N	11/02/2006	11/05/2006	3	NONE	PUB	PUB	LoEstrin 24	NONE	NONE			1						1	Erythema; Feeling hot; Oedema peripheral; Pruritus	FLU3~SANOFI PASTEUR~UZ196AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266181	11/07/2006	CA	8.0	8		M	11/06/2006	Fever of 104.5, swelling, redness, pain left shoulder.  Headache.  IV Ancef, oral Keflex				Y						11/01/2006	11/01/2006	0		UNK	UNK			arachnoid cyst, acenesis corpus callosum, hydrocephalus, shunt, seizures	cellulits~DTaP (no brand name)~4~5.00~Patient		1						1	Erythema; Headache; Injection site pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U2186AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~SANOFI PASTEUR~UC454AA~1~SC~RA~MENINGOCOCCAL (MENOMUNE)~1|PPV~MERCK & CO. INC.~1117R~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0266182	11/07/2006	CA	19.0	19		M	11/06/2006	T 103, Cellulitis right shoulder Tx IV Ancef, PO Keflex.				Y						11/01/2006	11/03/2006	2	WBC 23,700, 73% Segs, 15% Bands, 7% Lymph's, T Bili 2.4.	UNK	UNK			Gallstone			1						1	Blood bilirubin increased; Cellulitis; Pyrexia; White blood cell count increased	FLU3~SANOFI PASTEUR~U2186AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2002AC~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PPV~MERCK & CO. INC.~1117R~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0266194	11/07/2006	SC	38.0	37		F	11/07/2006	Left deltoid area red (approximately 30 mm redness), swollen, and warm to touch.  Denies pain or fever.									Y	10/31/2006	11/01/2006	1		UNK	UNK	NONE	NONE	Allergic to penicillin		SC0621	1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA215AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0266196	11/07/2006	NC	46.0	46		F	11/07/2006	Vaccinated on 10/31/06 with Tdap, flumist and Tb test. That night at home, she noted sore arm that got worse the next day. When she presented to the clinic on 11/2/06, there was swelling, erythema, pain and induration at injection site. This was causing some restriction of her ROM and tingling in hand/fingers.  Recommended OTC Ibuprofen and cold compress to injection site. Described severe allergic systemic reaction that would require emergent medical attention.									Y	10/31/2006	10/31/2006	0	n/a	MIL	MIL	Allegra anti-hypertensive statin	none	HTN hyperlipidemia seasonal allergies			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling; Joint range of motion decreased; Paraesthesia	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TDAP~SANOFI PASTEUR~C2559AA~1~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0266197	11/07/2006	NC	41.0	41		F	11/07/2006	Vaccinated on 10/31/06 with Tdap, flu shot and Tb test. 30 minutes after vaccination she noted pain in the arm injected with Tdap. She continues to have pain in the arm along with swelling and numbness. Recommended OTC Ibuprofen and cold compress to injection site. Aware of s/s of severe allergic systemic reaction and need to seek emergent medical attention should she develop such signs.									Y	10/31/2006	10/31/2006	0	n/a	MIL	MIL	Proventil inhaler	none	Diabetes;  HTN;  Asthma			1						1	Hypoaesthesia; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TDAP~SANOFI PASTEUR~C2559AA~1~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0266198	11/07/2006	NC	44.0	44		F	11/07/2006	Vaccinated on 10/31/06 with Tdap and flu shot and also received a Tb test that day. The next day she noted her arm was sore with a knot at the injection site of the Tdap. Over the next several hours the injection site became hard, hot and painful. She is also having some itching at the injection site today.  Recommended OTC Ibuprofen and cold compress for pain relief of injection site. Described s/s of severe allergic reaction and need to seek emergent medical care if she should develop any s/s.										10/31/2006	11/01/2006	1	n/a	MIL	MIL		none	none			1						1	Injection site hypersensitivity; Injection site induration; Injection site mass; Injection site pain; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U2286AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2559AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0266202	11/07/2006	NC	40.0	40		F	11/07/2006	Vaccinated with Tdap, flu and received Tb test on 10/31/06. She notes that she felt bad a few hours after being vaccinated with flu like symptoms. The s/s gradually worsened over the next 24 hours and she also developed pain, swelling and redness at injection site of both vaccines, the flu shot site worse than the other. She did have some mild tingling and numbness in L arm. Recommended OTC Ibuprofen and cold compresses to injection site for pain relief. Described s/s of severe adverse reaction and to seek emergent care if she develops such.									U	10/31/2006	10/31/2006	0	n/a	MIL	MIL	none	none	seasonal allergies			1						1	Influenza like illness; Injection site erythema; Injection site pain; Injection site swelling; Malaise	FLU3~SANOFI PASTEUR~U2199AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2556AA~1~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0266205	11/07/2006	TX	1.09	1	.1	M	11/07/2006	Apparently healthy 13 montly old fraternal male twin received vaccines (see below) at approximately 9AM on 11/2/06.  Approximately 12 hours later child experienced seizure at home.  EMT came to home and gave Versed to patient at about 10:30PM and child was brought to ER.  Temp at ER 101.8 (rectal).  At about 11:15PM child experienced respiratory failure, attempte was made to intubate; child pronounced dead at approximately 12:02AM on 11/3/06.  2/22/07 Received autopsy report which reveals COD as complications of midazolam administration following a s/p vaccination benign febrile seizure.	Y	11/03/2006	Y	Y					N	11/02/2006	11/02/2006	0	WBC 44,800, Potassium 3.3; rectal temp in ER 101.8	UNK	UNK	Patient reportedly was given Versed by EMT approximately 45 minutes before respiratory arrest	none reported	child was born at 34-35 gestation.  Is a fraternal twin; sister received same immunizations at same visit on 11/2/06.			1						1	Pyrexia; Respiratory failure; White blood cell count increased; Body temperature increased; Convulsion	FLU3~SANOFI PASTEUR~U2196AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~UNKNOWN MANUFACTURER~C0806~3~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0950F~1~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|FLU3~SANOFI PASTEUR~U2196AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|IPV~SANOFI PASTEUR~Z0306~3~SC~RL~POLIO VIRUS, INACT. (IPOL)~2|MMR~MERCK & CO. INC.~0950F~1~SC~LL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~2|PNC~PFIZER\WYETH~B08646B~4~IM~RL~PNEUMO (PREVNAR)~2	USA	Results in Death	Influenza
0266206	11/07/2006	CO	75.0	75		F	11/07/2006	Patient walked away and a minute or so later came back and reported she was dizzy.  She sat down and became flushed.  5-10 minutes later she said she was short of breath.  She did not have any wheezy breath sounds or signs of constriction or localized reactions at injection sites.   MR received from hospital. PMH: 75 yr. old with hx. of depression osteoarthritis, CAD, reflux and urinary stress incontinence.  Within 5-10 minutes of receiving pneumovax, pt. became dizzy, flushed, short of breath, and experienced some chest pressure and muscle spasm.  Evaluated in ER where she was stable. PE was normal.  Given cardiac hx. she was admitted for serial cardiac enzymes and observation o/n. She remained stable with no c/o  chest pain or SOB.  Discharged next day.  Assessment: Allergic reaction to Pneumovax.				Y	Y	1			Y	11/02/2006	11/02/2006	0	LABS and Diagnostics: EKG, cardiac enzymes, CBC, and CXR all WNL.  BMP significant only for glucose of 148.	UNK	UNK	Meds: Prozac, ? med for urinary incont., premarin cream, and Nitrostat PRN.		Patient had previous atrial fibrillation. PMH: 75 yr. old with hx. of depression osteoarthritis, CAD, reflux and urinary stress incontinence.			1						1	Blood glucose increased; Chest discomfort; Dizziness; Dyspnoea; Flushing; Hypersensitivity; Muscle spasms	FLU3~SANOFI PASTEUR~u2218aa~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0352f~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0266207	11/07/2006	MD	36.0	36		M	11/07/2006	NONE										11/03/2006				UNK	UNK		NONE	NO KNOWN ALLERGIES			1						1	Unevaluable event	DTAP~SANOFI PASTEUR~C2489AA~UNK~IM~LA~DTAP (DAPTACEL)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72818~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266208	11/07/2006	CA	38.0	38		F	11/07/2006	Had vaccine at approximately 3:30pm on 10/31, noticed symptoms at 8:30pm: swollen lips, and at 7:00am on 11/01 woke up with hives around neck, and lips still swollen.  Hives lasted until about 9:30am.  Treated with over the counter cortisone cream in am.  No PO meds except iron supplement, and metro lotion for treament of rosacea - only on face.  Have had injectable flu shots the last three years with no problem.									Y	10/31/2006	10/31/2006	0		UNK	UNK	Metro Lotion for face	None	Rosacea on cheeks			1						1	Face oedema; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500432P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0266209	11/07/2006	CA	25.0	25		F	11/07/2006	Received flumist at 3:45pm, immediately followed by flushed face and warm ears, at 5:00 pm developed chills & sleepness, hives developed at 12:30 pm on 11/1, took 25 mg of Benadryl, no other problems.  Client has had injectable flu vaccines in the past with no reactions.									Y	10/31/2006	10/31/2006	0		UNK	UNK	Celexa 20 mg once per day, Flonase once per day, Restoril at pm PRN for sleep, and birth control pills.	None	None			1						1	Chills; Feeling hot; Flushing; Somnolence; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500438P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0266211	11/07/2006	VA	48.0	48		F	11/07/2006	Given at ~12noon--No problems except sore arm until dinnertime then c/o feelings of periodic heart palpitations like I had just run a marathon and mild SOB; continued on & off through next day as well.  No other complaints.									Y	11/06/2006	11/06/2006	0	None	UNK	UNK	None	None	States: Had same type of feelings x 2 postpartum due to hyperthyroid problem--latest 11 years ago			1						1	Dyspnoea; Pain; Palpitations	FLU3~SANOFI PASTEUR~U2241AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266212	11/07/2006	GA	72.0	72		F	11/07/2006	PATIENT'S LT ARM BEGAN FEELING SORE AND REDNESS NOTED AROUND 12:00 P.M.LATER IN EVENING, PATIENT BEGAN HAVING CHILLS, FEVER AND LT ARM STILL NOTED RED. PATIENT STATES TOOK #2 BABY ASA LAST NIGHT @ 7:30 P.M. AND FEVER AND CHILLS SUBSIDED THIS A.M. PRESENTED TO CLINIC @ 3:30 P.M. WITH A 6 X 5 AREA TO LT ARM WITH LIGHT REDNESS,WARM TO TOUCH AND LOWER AREA RAISED.PATIENT C/O LT ARM STILL SORE SOMEWHAT.STATES WENT TO HEART DOCTOR EARLIER TODAY AND HE SENT HER TO THIS CLINIC FOR NURSE TO OBSERVE REACTION. ADVISED PATIENT TO RETURN HOME AND PLACE COOL COMPRESSES AND TAKE TYLENOL PRN.									U	11/06/2006	11/06/2006	0		UNK	UNK	LASIX, COREG, POTASSIUM, AMPARIL, BABY ASA, PREVACID		HEART ATTACK, PACEMAKER, DEFIBRILLATOR, HTN. ALLERGIES: CASHEWS, TETANUS SHOTS, CERTAIN COLD MEDS.			1						1	Chills; Injection site erythema; Injection site warmth; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601311~5~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1007P~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266213	11/07/2006	CA	0.0	49		M	11/07/2006	10/31 flu shot administered approximately 1400, asymptomatic. 11/01 complaint of severe headache, myalgia. 11/2 fever (up to 108) chills, myalgia. 11/6 presents with complaint of chills, low grade temp. and myalgia. Referred to work comp. pysician.				Y					U	10/31/2006	11/01/2006	1		UNK	UNK	Cozar 100mg po QD  (3years) Verapamil 240mg po QD (2 years) Tezanidine 4mg po QD BID (1year) Lyrica 75mg po BID (1year)	denies illness	allergic to Erythromycin and contrast dye			1						1	Chills; Headache; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U2218AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266215	11/07/2006	CO	48.0	48		F	11/07/2006	Patient called to pharmacy and stated that after 2 week she was still having difficulties moving the arm that she got the vaccination in.  She has tried taking ibuprofen, applying heat and anagelsic rubs but still has difficulties with activities of daily living like dressing.									U	10/23/2006	10/24/2006	1	none known	UNK	UNK		none known	none known			1						1	Hypokinesia; Pain	FLU3~SANOFI PASTEUR~u2218aa~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266216	11/07/2006	CA	56.0	56		F	11/07/2006	11/3/2006 NOON - HIVES ON FACE, QUICKLY SPREAD TO NECK.  DULL HEADACHE. 11/3/2006 1:30 PM - HIVES ON RIGHT WRIST. 11/3/2006 3:30 PM - HIVES ON WRIST AND NECK IMPROVE. 11/3/2006 5:30 PM AND 10:00 PM - TOOK ACETAMINOPHEN. 11/4/2006 12:00 AM - HIVES ON FACE, NECK, WRIST REAPPEAR.  SWEATING. 11/4/2006 7:00 AM - HIVES GONE. INTERMITTENT HEADACHE.  FATIGUE, NAUSEA, MALAISE. 11/4/2006 10:00 AM - TOOK AIRBORNE									Y	11/03/2006	11/03/2006	0	NONE	UNK	UNK	NONE	NONE (MENOPAUSE)	MENOPAUSE; ALLERGY TO ASPIRIN (GETS WELTS ON LIPS)			1						1	Fatigue; Headache; Hyperhidrosis; Malaise; Nausea; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71216~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266217	11/07/2006	CT	24.0	24		F	11/07/2006	Fever of 102, total body aching, muscle, joint, and bone pain.  Chills, red blotchness on arm. DC DX: DOS 11/7/06-Resolving allergic reaction to flu shot. Immediately after receiving flu shot experienced server pain in injection sit. Later that day had server chills and shaking, myalfgia. Treated with tylenol and fluids. Follow-up: 3pm 11/6/06 received flu vaccine - developed immediate pain at site 7/10 intensely \ persisted - Later in evening entire body aching 10/10 with shaking shaking so hard - heart hurt, heart aching took BENADRYL no helping 4 AM took TYLENOL 11/7/06. 11/7/06 9AM seen in student medical clinic T 101 degrees P 128 120/70 flushed. Blotchy rash body ache. Decreased to back and lower legs 8-9/10.				Y	Y	1			Y	11/06/2006	11/06/2006	0	negative strep test	OTH	PVT	none; FLONASE; BC pill	none; was feeling well	Allergies to sulfa drugs. Hx seasonal allergies			1						1	Chills; Erythema; Hypersensitivity; Injection site pain; Myalgia; Pain; Pyrexia; Rash macular; Streptococcal identification test negative; Tremor	FLU3~SANOFI PASTEUR~U2197AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0266218	11/07/2006	CA	62.0	62		M	11/07/2006	Client presented to ED 10/29/06 with lower extremity weakness and pain. He was admitted to the Med/surg unit for testing. CT unremarkable, EMG studies showed demyelinating polyneuropathy. CSF protein slightly elevated. A few days later was admitted to Critical Care Unit due to increased weakness and paralysis. Shortly after admission to CCU, was intubated and dialyzed. He is now undergoing plasmaphoresis treatment. He has been positively diagnosed with Guillan-Barre Syndrome.			Y	Y	Y	11	Y		U	10/20/2006	10/29/2006	9	LP-Positive for protein, Negative CT, EMG Studies positive for demyelinating neuropathy.	UNK	UNK	lipitor	Had muscle weakness for past 6 months, according to wife.	Increased cholesterol level, post rotator cuff sx.			1						1	CSF test abnormal; Demyelination; Guillain-Barre syndrome; Hypoxia; Muscular weakness; Pain; Paralysis; Polyneuropathy	FLU3~SANOFI PASTEUR~U2193AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0266219	11/07/2006	WI	29.0	29		F	11/07/2006	Hives, itching				Y					Y	11/01/2006	11/01/2006	0		UNK	UNK	albuterol	none	Diabetes, asthma			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~u2212aa~4~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266233	11/07/2006	AZ	66.0	66		M	11/07/2006	At approximately 2:00 pm his arm started feeling bad, but he kept working in the yard until 7:00 pm at which time he went inside and took a shower. His arm was swollen and he started getting chills. Monday he was better, but today he still feels a headache and he can't sleep on his arm.									Y	11/03/2006	11/03/2006	0		PUB	PVT	NONE					1						1	Chills; Headache; Malaise; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70736~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0485F~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266236	11/07/2006	SC	23.0	23		F	11/07/2006	Red, knot with fever in it cm right deltoid where flu shot was given! 3.5 cm by 3.5 cm									Y	11/06/2006	11/06/2006	0	NONE	PVT	PVT		NONE	IBS	red, fever, knot~Influenza (Seasonal) (Fluzone)~1~23.00~In Patient		1						1	Injection site erythema; Injection site mass; Injection site warmth	FLU3~SANOFI PASTEUR~U2248AA~3~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266237	11/07/2006	SC	34.0	34		F	11/07/2006	Site of injection was sore, red, feverish, bruised. Induration measured by nurse practioner x4.5 cm									Y	11/06/2006	11/07/2006	1		PVT	PVT	Phentermine, Orthotricyclen, Lexapro	NONE	Possible Sulfa Allergy	swelling, redness arm~Influenza (Seasonal) (no brand name)~7~33.00~In Patient		1						1	Contusion; Injection site erythema; Injection site induration; Injection site pain; Injection site reaction; Injection site warmth	FLU3~SANOFI PASTEUR~U2248AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266230	11/08/2006	GA	45.0	45		F	11/07/2006	Patient immediately felt pain down right arm, pain increased during afternoon.  Patient went to emergency room in evening and received morphine injection.  As of 11-7-2006 in evening symptoms are improving.				Y					N	11/06/2006	11/06/2006	0		OTH	PVT	Fluoxetine, Trazodone, Alprazolam, Sorna, Clonazepale, Hydrocodone APAP		nerve damage in left arm			1						1	Pain	FLU3~SANOFI PASTEUR~U2167NA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1048P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0266232	11/08/2006	NV	42.0	42		F	11/06/2006	Right arm swollen/erythema/headache 9 hours after vaccine given. Provider was not aware at vaccination time that patient had a history of lupus.				Y					U	11/03/2006	11/04/2006	1		PVT	PVT		NONE	Penicillin allergy			1						1	Erythema; Headache; Swelling	FLU3~SANOFI PASTEUR~U2193AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0620F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~UNKNOWN MANUFACTURER~U17B0GA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0266242	11/08/2006	NY	49.0	49		F	11/03/2006	Initial report received on 10/26/06 from a health care professional. A 49 year old pt, with a history of asthma and allergy to penicillin, Keflex, Ceclor, Anaprox, Clindamycin, Vancomycin, and sulfa drugs, had received an IM injection of Fluzone SV 2006-2006, lot number U2199AA, on 10/26/06 at 14:35pm. The site and route of administration was not reported. Ten minutes post immunization, the pt experienced left side numbness from the lip to the ear that was progressing to the left eye. The pt denied any dysphagia or dyspnea. Diagnostic and treatments received were not reported. The reporter considered these adverse events as other medical important events (OMIC). The recovery of the pt is unk.				Y					U	10/26/2006	10/26/2006	0		UNK	UNK			The patient has a history of asthma and allergy to Penicillin, Keflex, Ceclor, Anaprox (anaphylaxis), Clindamycin, Vancomycin, Sulfa drugs		200602838	1						1	Hypoaesthesia; Hypoaesthesia	FLU3~SANOFI PASTEUR~U2199AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2199AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0266243	11/08/2006	KY	15.0	15		M	11/03/2006	Seriousness criteria other medically significant (OMIC). Initial report received on 10/27/06 from a health care professional. A 15 year old male pt, with no concurrent illnesses, and a history of reactive airways disease, and allergy to Sulfa drugs and Penicillin, had received a left arm, IM injection of Fluzone SV 2006-2007 USP, lot number U2257AA, on 10/25/2006 at 16:45pm. At approx 17:45pm, one hour post immunization, the pt went to the ER with generalized hives and shortness of breath. He was treated with Solu Medrol, Benadryl IV, and Albuterol nebulizer. Diagnost6ics performed were not reported. At the time of this report, the pt had recovered.				Y					Y	10/25/2006	10/25/2006	0		UNK	UNK			The pt had no illnesses at the time of vaccination on 10/25/2006. The pt does have a history of RAD, and allergy to sulfa and Penicillin. Other medications the pt was taking at the time of the vaccination were not provided.		200602851	1						1	Dyspnoea; Urticaria	FLU3~SANOFI PASTEUR~U2257AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266249	11/08/2006	CO	23.0	23		M	10/31/2006	Pt passed out approx 5 min after vaccine administration, for about 1 minute. Felt well, returned to work at approx 30 mins after vaccine admin. didn't feel well and became disoriented. Had amnesia for next few hours until hospitalization. Was hospitalized x 24 hours and had w/u including MRI, Lab, Exam all neg. 12/8/06 Received medical records from hospital which reveal patient  had flu shot at work & became confused approx 2 hours s/p flu shot.  Patient had been ill & left work day before flu vax.  Was admitted to hospital 10/24/06 & remained overnight for observation.  Neuro consult done Final Dx: Acute mental status changes & increased bilirubin.  Allergy to flu shot.				Y	Y	1			Y	10/24/2006	10/24/2006	0	LABS: WBC 14,300, lymphs 9.7, mono 0.7, NE# 12.  CT of head was WNL. EKG was WNL.	OTH	OTH	NONE	Viral illness 24 hours before vaccine				1						1	Amnesia; Depressed level of consciousness; Disorientation; Hypersensitivity; Laboratory test abnormal; Loss of consciousness; Malaise; Vaccination complication	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69480~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0266250	11/08/2006		24.0	0	.1	F	11/08/2006	Pt received Td injection on Saturday November 4th .Pt presented 8 Nov with induration and erythema over right deltoid 40x45mm (golf ball size).  She states it was twice as big on Monday (6 Nov).  She states she felt burning pain over right deltoid approximately 1 hour after injection received.  She states swelling and readness with muscle pain peaked 48 hours later.  She also states she had tiny blisters over site. Blisters were not visible on 8 Nov.									Y	11/04/2006	11/04/2006	0		MIL	MIL						1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site vesicles; Myalgia; Thermal burn	FLU3~SANOFI PASTEUR~U2286AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~AVENTIS PASTEUR~U1879AA~1~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0266251	11/08/2006	NY	65.0	65		F	11/08/2006	Progressive symmetric lower extremity motor weakness extending to the upper extremities (power 2/5 both upper and lower extremities) with gradual loss of deep tendon reflexes till they were absent. Clinical diagnosis of GUILLAIN-BARRE syndrome. Transferred to intensive care unit on 10/28/06. Did not require intubation. Developed autonomic dysfunction with variable blood pressure and intermittent sinus tachycardia. Started on plasmapheresis (total 6 sessions) on 10/28/06 and responded with recovery of motor strength.				Y	Y	13	Y		Y	10/11/2006	10/25/2006	14	Negative MRI/CT of c-spine. LP (<1 week from onset of symptoms) showed protein of 46.6 with no WBC.	UNK	UNK	Lipitor 20mg po qday Levoxyl 100mcg po qday ASA 81mg po qday	None	Hypothyroidism Hypercholesterolemia Arthritis			1						1	Guillain-Barre syndrome; Hyporeflexia; Muscular weakness; Sinus tachycardia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70385~2~ID~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0266253	11/08/2006	TX	55.0	55		F	11/08/2006	Spouse called RN at home approximately 4 hrs. after shot, states left upper arm grossly swollen, redden and warm to touch. Size of a baseball painful to move arm and client is crying. treated with cold compress, Advil X4 tabs, and Benadryl X2 at home. 11/8 at 8 am, area still red and enlarged. Not as painful and planning to go to work today. No doctor seen yet.										11/07/2006	11/07/2006	0		UNK	UNK	unknown	unknown	not known			1						1	Crying; Erythema; Injection site warmth; Pain; Swelling; Feeling hot; Pain; Swelling	FLU3~SANOFI PASTEUR~U2253AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2253AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0266253	11/08/2006	TX	55.0	55		F	11/08/2006	Left upper arm - grossly swollen, red area size of baseball. Warm to touch and painful to move arm. Reported by spouse at 6:47 PM evening of shot. Treated with cold compress, Advil and Benadryl.									U	11/07/2006	11/07/2006	0		PUB	PVT		NONE	NONE			1						2	Crying; Erythema; Injection site warmth; Pain; Swelling; Feeling hot; Pain; Swelling	FLU3~SANOFI PASTEUR~U2253AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2253AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0266254	11/08/2006	NY	68.0	68		F	11/08/2006	Approximately 9 hours after being vaccinated patient reported awaking with heart palpitations.  She went to the Emergency Department and reports that she was diagnosed with Atrial Fibrillation.				Y					Y	10/18/2006	10/19/2006	1	Unknown	UNK	UNK	None	None	Unknown			1						1	Atrial fibrillation; Palpitations	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71210~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB287AA~1~IM~LA~HEP B (ENGERIX-B)~1|TD~MASS. PUB HLTH BIOL LAB~Td154~1~IM~LA~TD ADSORBED (TDVAX)~1	USA	Emergency room visit	Influenza
0266255	11/08/2006	NY	70.0	70		F	11/08/2006	Immediately after receiving a dose of flu vaccine patients right arm developed approximately quarter sized area of swelling with pain.  There was no redness or discoloration.									Y	10/24/2006	10/24/2006	0	None	UNK	UNK	Unknown	None	Unknown			1						1	Pain; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70739~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1040P~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266256	11/08/2006	OH	44.0	44		F	11/08/2006	Swelling of left shoulder, collar bone, left neck area up to jaw.				Y					Y	10/25/2006	10/25/2006	0		MIL	OTH			Macrodantin-hives			1						1	Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70741~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0266257	11/08/2006	MD	0.38	0	.4	M	11/08/2006	12/01/04: Dry cough, fever; seen at Dr's office. Diagnosed with bronchiotitis. No medication prescribed. Advised to use humidifier.  12/02/04: Synagis shot given at home by hospise nurse. This was a regular procedure since he was premature. 12/02/04: I called doctor's office to cancel well baby appointment, because he had just been seen the day before for a bad cough. I didn't think he should keep his appointment for his immunizations when he was this sick. The nurse said that if I didn't keep the appointment that we would be dropped as a patient and charged for a missed appointment. I said that typically with my other children, doctors don't want to give immunizations when the child is sick and tell me to reschedule well-baby appointments. I took him in because of her threats. He was seen by the doctor that day. I re-stated my concern about giving him immunizations when he was sick. He convinced me that it would be fine.  He was given four more shots that day (listed below) 12/03/2004: My husband and I were up early because he had an early day at work. (4 am) When I checked on him, he seemed to be sleeping in an odd position. When I went to adjust him, his head fell back and he was limp and not breathing. We called 911. While we waited for the ambulance, they told me to breathe softly into his mouth. I did with no response.  In the emergency room, they tried to revive him, but he died.	Y	12/03/2004							N	12/02/2004	12/03/2004	1	Autopsy report: I'm still waiting for my copy, which I had to send for in writing. On 12/03/2004, I was told that there would be a police report and an autopsy which is standard procedure in the death of an infant. I told them I was glad, and that I was anxious to find out if the immunizations were the cause of death. Weeks later, I was given verbal results over the phone. After they told me all of the things that did NOT cause his death, they said that they were listing the cause as unknown natural causes and later they had to change it to SIDS because they had to put something other than unknown When I asked about the results of the test for reaction to vaccines, she said they didn't test for that. I was shocked and disappointed, because for us, that was the most important test to be given!	UNK	UNK	Synagis	Cold, cough, fever (Doctor's office said there was no fever, but he had a fever at home prior to appointment.)	Premature			1						1	Apnoea; Bronchiolitis; Cough; Hypotonia; Pyrexia	DTAP~UNKNOWN MANUFACTURER~~2~IM~RL~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~2~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~2~IM~LA~HIB (NO BRAND NAME)~1|OPV~UNKNOWN MANUFACTURER~~2~IM~RA~POLIO VIRUS, ORAL (NO BRAND NAME)~1	USA	Results in Death	Influenza
0266258	11/08/2006	MD	30.0	30		M	11/08/2006	10/26/2006 smallpox vaccination by vaccinia innoculation. Pt reports 1 wk F NS 4d multifocal pustular eruptions upper torso, gluteal area, UE/ LE. ROS otherwise negative.  No conjunctival findings. HR 75. COR PULM unremarkable. Lesions as described, only original innoculum site on LUE with eschar. Bilateral axillary LN L>R. No relevant PMHx or family Hx. Apparently spouse healthy. No children.  Our clinical impression was generalized vaccinia, low severity. Discussed role of contact precautions at home and at work, avoidance of patient care, monitoring for superinfection with both patient and his PCM.  Patient subsequently evaluated by Dermatology. They felt rash more consistent with vaccination folliculitis. Appreciated their evaluation and reference. However, in setting of LN on R as well and systemic sx (F NS) may be a mixed syndrome, or atypical GV. No change to our recommendations. Patient has excellent following and we remain available for urgencies or questions.				Y					U	10/26/2006	11/03/2006	8	CBC W/o Diff Site/Specimen 07 Nov 2006 1011 Units Ref Rng  WBC BLOOD 5.8 x10(3)/mcL (4.0-11.0)  RBC BLOOD 4.93 x10(6)/mcL (4.70-6.10)  Hgb BLOOD 14.3 g/dL (14.0-18.0)  Hct BLOOD 40.8 (L)  % (42-52)  MCV BLOOD 83.0 fL (80.0-94.0)  MCH BLOOD 29.1 pg (27.0-32.0)  MCHC BLOOD 35.1 % (31.0-37.0)  Plt BLOOD 185 x10(3)/mcL (150-450)  RDW-CV BLOOD 12.6 % (11.5-14.5)  MPV BLOOD 8.4 fL (7.4-10.4)	MIL	MIL						1						1	Folliculitis; Rash pustular	FLUN3~MEDIMMUNE VACCINES, INC.~500437P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~PFIZER\WYETH~4020072~1~ID~~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0266260	11/08/2006	WI	71.0	71		F	11/08/2006	Patient had a very large (approx. 20 cm diameter) confluent, blanchable urticarial plaque at immunization site on left deltoid, that was moderately erythematous, tender, and warm to touch. Patient denies having any fever, chills, dyspnea, or other illness.									U	10/24/2006	10/25/2006	1	N/A	UNK	UNK	Unknown	None	Unknown			1						1	Injection site erythema; Injection site pain; Injection site urticaria; Injection site warmth	FLU3~SANOFI PASTEUR~U2212AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0619F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266261	11/08/2006	KS	56.0	56		F	11/08/2006	Symptoms began 6 hours following the vaccination.  They began with a sore, scratchy throat followed by a 7 - 12+ day course of fever, sore throat, myalgia, nasal coongestion, cough, weakness, fatigue, runny nose, dry cough followed by a productive cough.  Symptoms of nasal/sinus congestion, runny nose, chest congestion, productive cough continue.									N	10/27/2006	10/27/2006	0		UNK	UNK		healthy, no illness	none			1						1	Asthenia; Cough; Fatigue; Myalgia; Nasal congestion; Pharyngolaryngeal pain; Rhinorrhoea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266262	11/08/2006	WA	55.0	55		F	11/08/2006	Next Day:  large, red, itchy welts under arms, waist area, inner thighs gone the next day.									Y	10/19/2006	10/20/2006	1		UNK	UNK		None	None			1						1	Erythema; Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71354~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266266	11/08/2006	CA	51.0	51		M	11/08/2006	Rash on arms and legs after flu shot. I noticed rash a little more than a day after shot.										11/06/2006	11/07/2006	1		UNK	UNK						1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0266269	11/08/2006	TN	9.0	9		F	11/08/2006	Was given a flu mist on 10/10/06.  This was her very first flu shot.  Two days later, she travelled with her parents.  She started blowing her nose on the plane and upon arrival, her cold got really bad that her nose was constantly running and sneezing.  Mother gave her 5 mg of Singulair thinking she had allergy but it got worse.  Before she slept that night, mother gave her a dose of cold meds at around 8+ pm.  Around 2+ AM, woke up to go to the bathroom.  When she got back to her bed, she started shaking violently facing down on the bed with limbs going up and down.  Her eyes were rolled up and mother could hear her chest congestion and she was having a hard time breathing or seemed to be not breathing.  This lasted about 2 mins.  EMS was called and she was brought to the ER.  She was monitored and sent home after 5 hours.  A Cat Scan was done and result was normal.  6 days later, she and her parents flew back home.  That night, she woke up at 10+ and started walking around.  Mother took her back to her bed.  As she was going down to her bed, she suddenly had a fright and was all stiffen up and shaking and her eyes rolled back again.  This episode also lasted for 2 mins.  EMS was called and she was brought to the ER to be monitored.  A contrast Cat Scan was done and was normal.  All other tests done appeared normal.  She was sent home after 7 hours.  The following week, an EEG was done and was reported normal.  On both occasions of travelling, she did not have much sleep prior to the flight and during the flight.  She has travelled numerous times a year since an infant, and has never had seizures in her life before now.  The seizure happened after she was given a flu shot.				Y					U	10/10/2006	10/13/2006	3	Since she had two seizures, the pediatric neurologist started her on Keppra.  A sleep test was ordered.	UNK	UNK	None	None	None			1						1	Convulsion; Dyspnoea; Eye movement disorder; Musculoskeletal stiffness; Nasal congestion; Rhinorrhoea; Sneezing; Tremor	FLUN3~MEDIMMUNE VACCINES, INC.~0000~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0266270	11/08/2006	WI	55.0	55		F	11/08/2006	Patient received vaccine on 11/7/06 at 1:45 pm. Patient awoke on 11/8/06 with aches, diaherra, and dizziness.									Y	11/07/2006	11/08/2006	1		UNK	UNK	High blood pressure med, asthmas & allergy meds, rec'd allergy vaccines on 10/30/06 for cats, grasses, trees, dogs, dustmites...	none - had viral infection (cold & cough) a few weeks ago	none			1						1	Diarrhoea; Dizziness; Pain	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0266271	11/08/2006	CA	62.0			M	11/08/2006	This case was reported by a physician and described the occurrence of Guillain Barre Syndrome in a 62 year old male subject who was vaccinated with Fluarix for prophylaxis. The subjects medical history, concurrent conditions and concurrent medications were not reported. On 10/24/06 the subject received 1st dose of Fluarix. The lot number and expiration date were not provided. An unspecified amount of time later, but on the same day as Fluarix administration, the subject experienced Guillian Barre syndrome. the subject was hospitalised on 10/29/06. The subject was treated with plasma exchange (Plasmapheresis), but did not respond. At the time of reporting the outcome of the event was unspecified.					Y	0			U	10/24/2006	10/24/2006	0		OTH	OTH					A0626459A	1						1	Guillain-Barre syndrome	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0266276	11/08/2006	NE	60.0	60		M	11/08/2006	Very sore arm with redness down to bicep.									Y	10/31/2006	11/03/2006	3	NONE	OTH	OTH		NONE	diabetes, hypertension, hypercholesterol			1						1	Erythema; Myalgia	FLU3~SANOFI PASTEUR~U2253AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266279	11/08/2006	MO	22.0	22		M	10/24/2006	Administered Fluvirin vaccine, patient collapsed and passed out. He came to and was sweating blood pressure 70/40, pulse 58, blood pressure 109/68, pulse 68, blood pressure 110/71, pulse 71.  Sat down and drank H20.  Felt better after 15 minutes.  Refused to emergency room.  Vasovagal, syncope.				Y					Y	10/20/2006	10/20/2006	0	blood pressure 70/40, 109/63, 119/71 on 10/20/06, physical exam: within normal limits on 10/21/06	OTH	PVT	Singular 10mg every day, Claritin 10mg every day, Nasocort AQ, Zen every 24 hours	NONE	Seasonal allergies			1						1	Circulatory collapse; Hyperhidrosis; Loss of consciousness; Syncope; Syncope vasovagal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71033~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0266280	11/08/2006	PA	70.0	69		F	11/06/2006	Syringe injected into deltoid nurse thought needle broke.  Patient complained of pain at site.  Site red, ambulance called and patient taken to emergency room. Health notified.				Y					Y	10/19/2006	10/19/2006	0	emergency care, diagnostic radiology	OTH	PUB		NONE	NONE			1						1	Injection site erythema; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~7156~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0266281	11/08/2006	IL	55.0	55		F	11/04/2006	Had vaccines on 10/25. Broke at in hives on Tuesday 10/31 treated myself with with cortisone and Benadryl. Had steroid injection at doctors office on 11/3. Nurse said I was second pt in there for hives that day. Will need to go back on 11/6 for another injection because I am still breaking out badly.				Y					Y	10/25/2006	10/25/2006	0	NONE	UNK	PVT			NONE			1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0266282	11/08/2006	OH	47.0	47		F	11/08/2006	Pt given Fluzone vaccine at 11:45, came back to office by 3pm with rash, warmth, hives on side of face. No rash redness at injection site.									U	11/07/2006	11/07/2006	0	NONE	PVT	PVT			Idiopathic neuropathy			1						1	Feeling hot; Rash; Urticaria	FLU3~SANOFI PASTEUR~U2204AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266283	11/08/2006	NY	70.0	70		F	11/02/2006	Localize reaction left arm 24 hours post vaccination. Warm, red, itchy, no treatment needed.									Y	10/31/2006	11/01/2006	1		PUB	UNK						1						1	Injection site erythema; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U2253AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266284	11/08/2006	NY	64.0	64		F	11/02/2006	Pt received the flu shot and her arm became red, itching within minutes. History of asthma, also hives treated with 25 mg Benadryl.				Y					Y	10/31/2006	10/31/2006	0		UNK	OTH			Asthma, Hives			1						1	Injection site erythema; Pruritus	FLU3~SANOFI PASTEUR~U2253AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266285	11/08/2006	UT	53.0	53		F	11/03/2006	After injection has sore arm. 5 hours later was unable to swallow felt like someone was sitting on chest. Eyes were dry like the eyelids were glued. Lips were tingling. Since could only breath about 30% was scared to fall asleep. On 11/3 was able to swallow and breath better. Chest still hurts probably from being tight for so long.									U	11/02/2006	11/02/2006	0		OTH	UNK	Avapro, Eulsta, Synthroid, Vitamins.		High blood pressure, thyroid condition, allergic to penicillin, Percocet, Keflex.			1						1	Chest discomfort; Chest pain; Dry eye; Dysphagia; Dyspnoea; Insomnia; Paraesthesia	FLU3~SANOFI PASTEUR~U3516AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266286	11/08/2006		49.0	48		M	11/08/2006	Muscle and tendon aching after AVA 4. With subsequent AVA immunization developed cramping during exercise. Discomfort interferes with sleep 2-3x week. Symptoms continue to present Muscle spasm, Muscle pain.									N	11/01/2003	11/01/2003	0	See attached	MIL	MIL	NONE	NONE	NONE			1						1	Discomfort; Muscle spasms; Myalgia; Sleep disorder; Tendon disorder	ANTH~EMERGENT BIOSOLUTIONS~FAV077~6~~UN~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U1147AA~7+~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266287	11/08/2006	ME	57.0	57		F	11/08/2006	Hoarseness to voice, bilateral periorbital edema, tightness in neck/throat, chest pain and pressure, exercise intolerance.									Y	11/07/2006	11/07/2006	0		PVT	PVT	Synthroid, Femora					1						1	Chest discomfort; Chest pain; Dysphonia; Periorbital oedema; Throat tightness	FLU3~SANOFI PASTEUR~U2201BA~4~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266289	11/08/2006	MN	58.0	58		F	11/08/2006	Received influenza vaccine at 7:30, pain in arm began at 12pm. Severe pain in shoulder, arm and radiating into neck area continued for 5 days. Swelling on day 1-3. No redness at injection site.									Y	11/03/2006	11/03/2006	0	NONE	PUB	PVT		NONE	Hypertension, High cholesterol.			1						1	Injection site oedema; Injection site pain; Neck pain; Shoulder pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72000~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266290	11/08/2006	OH	20.0	20		M	10/26/2006	Mild GI symptoms prior to receiving vaccine. By evening N/O diarrhea Friday am T 101F with Tylenol symptoms until Sat. Sun am went to med center. DX bilateral otitis media neg for influenza ATB and cough medicine. Mon better.				Y					Y	10/19/2006	10/19/2006	0	Flu neg	PUB	PUB		Nausea, Diarrhea				1						1	Cough; Diarrhoea; Otitis media; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500437P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0266291	11/08/2006	NY	70.0	70		F	10/21/2006	Five hrs after receiving flu vaccine I began to tremor extensively (entire body) and could not control my hands to use telephone. Tremors lasted approx two hours, then subsided. the identical adverse event occurred with last years vaccine.									Y	10/13/2006	10/13/2006	0		PVT	UNK	Furosemide	NONE	Ibuprofen allergy.	tremors~Influenza (Seasonal) (no brand name)~~69.00~In Patient		1						1	Tremor; Vaccine positive rechallenge	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70735~7+~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266292	11/08/2006	ME	41.0	41		F	11/03/2006	Generalized soreness, blotchy red, non raised areas on inner upper left arm. Mild LAD noted. No signs of infection or cellulitis.									Y	11/01/2006	11/01/2006	0		PVT	PUB		NONE	Splenectomy			1						1	Injection site erythema; Injection site pain; Rash macular	FLU3~SANOFI PASTEUR~U2286AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0485F~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266293	11/08/2006	OH	33.0	33		F	11/01/2006	2PM received vaccine, developed 2:30pm hives face, 4:00 pm pt took Benadryl 25 mg PO Of her own. Pt also has multiple hives on torso and legs.									U	11/01/2006	11/01/2006	0		OTH	PVT	Profin					1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69898~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266294	11/08/2006	WI	70.0	69		F	11/03/2006	11/2 2:30 got up, dizziness, weakness. Rested for a couple hours. Had HA when got up took Tylenol and HA gone after 1/2 hour. Slight HA today. Normally dose not have HA.									Y	11/01/2006	11/02/2006	1	BP 152/74	PUB	PUB	Lisinopril, HCT, Metropol, Fosamax, K+, Lipitor.	NONE	Hypertension			1						1	Asthenia; Dizziness; Headache; Hypertension	FLU3~SANOFI PASTEUR~U2242AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266295	11/08/2006	MI	13.0	12		M	11/03/2006	Tremors, chills, with fever occurred about 2am vaccines need about 12 hours earlier. No unconsciousness. Fatigue, diffuse myalgia but no WKNS and nl neurologic exam,									U	11/01/2006	11/02/2006	1		PVT	UNK	Motrin		HX chronic OM in early childhood			1						1	Chills; Fatigue; Myalgia; Pyrexia; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~U2195AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~C2572AA~1~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0266296	11/08/2006	AL	16.0	16		M	11/03/2006	Onset dizziness 24 hours no vomiting.  No findings on physical.  No ataxic gait.									Y	10/24/2006	10/25/2006	1	CBC normal	PVT	PVT	NONE	NONE	NONE			1						1	Dizziness	FLUN3~MEDIMMUNE VACCINES, INC.~500438P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0266298	11/08/2006	PA	58.0	58		F	11/02/2006	Tired flu symptoms then the rash started-just a few each day and only on one side of the body, went to doctors, said it was shingles.				Y					Y	10/18/2006	10/25/2006	7	Doctor said it was from the Influenza shot-it is going away gradually	OTH	OTH	NONE					1						1	Fatigue; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69479~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0266299	11/08/2006	RI	12.0	12		M	10/31/2006	15-20 minutes after receiving FluMist, Varivax, and Tdap. Mother called clinic. Pt had on eye swollen and other eye starting to swell. Told to call 911 and take to ER.  MR received from PCP revealing a healthy 12 yr. old who received Varivax, Boostrix, and Flumist on 10/30/2006 and within 15-20 minutes developed swelling of the eyes.  He was taken to the ER where he was treated with Benadryl, and was doing well per MD report. Hospital MR received documenting visit for c/o itching, facial swelling, mouth swelling, and trouble breathing. PE: WNL with peri-orbital erythema. Patient had Benadryl and symptoms were resolving. DX: Allergic reaction.				Y					Y	10/30/2006	10/30/2006	0		PUB	UNK	Meds: none		PMH: none.  Allergies: rxn to eggs in the past but now tolerates.			1						1	Eye oedema	FLUN3~MEDIMMUNE VACCINES, INC.~500437P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B01BA~UNK~IM~UN~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~0920F~UNK~SC~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0266300	11/08/2006	TX	17.0	17		M	11/01/2006	Developed a rash around 2 hours after administered. Rash started at inside crease of elbow and spread down to hand. Prickly rash. Benadryl applied and Zyrtec given PO. Rash persisted through morning.									Y	10/31/2006	10/31/2006	0	NONE	OTH	PVT	Singulair, Zyrtec for seasonal allergies.	NONE	Seasonal allergies.			1						1	Rash	FLU3~SANOFI PASTEUR~U2216AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0485F~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266302	11/08/2006	AL	20.0	20		F	10/31/2006	Throbbing pain at injection site radiation to arm pit area, inj site deltoid, began 8-9 hours after immunization, difficulty lifting arm, driving gradually got better over 48-72 hrs.									Y	10/30/2006	10/31/2006	1		PVT	PVT		NONE	Diagnosed with strep throat 2 days later.			1						1	Hypokinesia; Injection site pain; Pain	FLU3~SANOFI PASTEUR~U2180AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0391F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266303	11/08/2006	GA	30.0	30		F		Pt given Fluarix 10/11/06 pm of 10/11/06 noticed rash on inner thighs 10/12/06 came to work, hands and feet swollen and red edematous itching rash. Dr ER physician saw her, Gave Medrol dose pack and Atarax RX.				Y					Y	10/11/2006	10/11/2006	0		PVT	PVT	Zyrtec	NONE				1						1	Erythema; Oedema peripheral; Rash; Rash pruritic	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA211AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0266304	11/08/2006	GA	5.0	5		F	11/02/2006	Patient had baseball-softball size (in diameter) and smaller hive like welts all over torso and back of knees. Over two days, spread to feet, neck, and face but was heaviest around waist and on back. She had a fever, above 102 F a few days prior to this that lasted maybe 12 hours and seemed pale and a bit labored with breathing. On Nov 1, 2006 rash disappeared except on feet and back and was completely gone by Nov 2, 2006. Benadryl. She remained out of school from 10/27-11/02/06.  Chronology of Visits report received which revealed well child with  PMH of urticaria and lactose intolerance who was seen 1 week after Varivax and Flumist for occurance of urticaria. DX: Urticaria				Y					Y	10/23/2006	10/30/2006	7	Doctor tested patient for Rapid strep test but came back negative on 10/30/06. Urinalysis was run for other reasons but doctor seems to have diagnosed with pharyngitis only.	PVT	UNK		None	Born premature at 35 weeks and 6 days. Had reflux as infant and Reactive Airway Disease/Asthma. PMH: urticaria and lactose intolerance			1						1	Dyspnoea; Pyrexia; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1|UNK~UNKNOWN MANUFACTURER~~UNK~~~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0266305	11/08/2006	CT	53.0	53		M	11/01/2006	Hives arms and legs.										10/30/2006	10/30/2006	0		PVT	PVT	NONE	NONE				1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69889~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266306	11/08/2006	OR	40.0	40		M	10/31/2006	Fever, chills, erythema/tenderness at site of injection at deltoid with lymphangitis extending into left axilla.									Y	10/26/2006	10/27/2006	1	NONE	PVT	PVT		NONE	Asthma			1						1	Chills; Injection site erythema; Injection site pain; Lymphangitis; Pyrexia	FLU3~SANOFI PASTEUR~U2251AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0486F~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266307	11/08/2006	IA	60.0	60		F	10/30/2006	Low grade fever, redness/mild erythema without induration on upper anterior and external rotation on right arm. Developed pneumonia; put on Levaquin.				Y					N	10/03/2006	10/03/2006	0	Chest x-ray	PVT	PVT		NONE	COPD; Asthma; TIA; Allergies to IVP Dye and codeine.			1						1	Drug ineffective; Erythema; Pneumonia; Pyrexia	FLU3~SANOFI PASTEUR~U2180AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1117R~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0266308	11/08/2006	IA	61.0	60		F	10/30/2006	4 cm x 7 cm redness, warmth. Put on Avelox & Zyrtec				Y					Y	10/25/2006	10/25/2006	0	None	PVT	PVT		NONE	HTN, Hyperlipidemia, allergies to Amoxicillin and Doxycycline.			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U2242AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1117R~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0266309	11/08/2006	NY	49.0	49		F	10/26/2006	Employee describes swelling and tenderness at injection site after influenza vaccination. Warm to touch and pain across left shoulder and down arm. Seen by PMD who diagnosed possible muscle infection. Rx with Levaquin for 10 days.				Y						10/19/2006	10/19/2006	0		PVT	PVT	Estrogen	NONE	Sulfa; Codeine			1						1	Infection; Injection site pain; Injection site swelling; Injection site warmth; Shoulder pain	FLU3~SANOFI PASTEUR~U2199AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266310	11/08/2006	TN	93.0	93		F	10/31/2006	Patient received vaccines. Within 5 minutes, patient was lightheaded, complaining of shortness of breath, felt very strange, and said her tongue felt numb. After getting information her symptoms progressed to wheezing, so an Epi-Pen was administered and 911 was called.				Y					Y	10/25/2006	10/25/2006	0		PUB	PUB	Lexapro; Nifedipine; Actonel; Mobic	NONE	Allergic: Ibuprofen, phenobarbital, Prednisone, furantoins			1						1	Dizziness; Dyspnoea; Feeling abnormal; Hypoaesthesia oral; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71644~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1036P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0266311	11/08/2006	PA	60.0	60		M	10/29/2006	Achy joints (elbows, knees, lower back, shoulders). Start Mon- Thurs. Tired (exhausted) general malaise unable to work for 3 days.									Y	10/13/2006	10/16/2006	3		OTH	PVT	Verapamil	None				1						1	Malaise; Pain	FLU3~SANOFI PASTEUR~U2165EA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266312	11/08/2006	CO		12		M		Patient given flu shot; 5 minutes later, patient fainted, unconscious for 5 seconds. Patient hit head; EMT called, assessed and cleared.									Y	10/24/2006	10/24/2006	0		PUB	OTH	Albuterol; Arodate	NONE	NONE			1						1	Injury; Syncope	FLU3~SANOFI PASTEUR~U2218AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266313	11/08/2006	OH	73.0	72		F	11/01/2006	Patient awoke 11/1/06 with reddened area 3 1/4 & 2 1/2 on L arm, laterally. Reports tenderness in area. Area of inflammation is 3-4 distal to deltoid. Denies fever. States was tired and had rhinitis but not other symptoms. Took Tylenol 10/30/06. No axillary node involvement.									Y	10/30/2006	11/01/2006	2		PUB	PUB	Allergy shots	None	Environmental allergies			1						1	Erythema; Injection site inflammation	FLU3~SANOFI PASTEUR~U2256AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266314	11/08/2006	TX	1.86	1	.9	F	10/31/2006	Rash (per mother - parent made phone call) over trunk and arms. Fine rash.									U	10/30/2006	10/31/2006	1	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Rash	DTAP~SANOFI PASTEUR~U1891CA~4~~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2174HA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0804F~1~~RL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~0466F~1~~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0266315	11/08/2006	CO	54.0	54		M	10/31/2006	Myalgias, headache, fatigue, loss of appetite, left shoulder pain, left arm pain.									Y	10/25/2006	10/26/2006	1	NONE	PVT	PVT			NKDA			1						1	Anorexia; Fatigue; Myalgia; Pain; Shoulder pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69427~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0881F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266318	11/08/2006	VA		3		F		Patches of raised bumps appearing sporadically - began 4.5 hours after vaccine.				Y						11/04/2006	11/04/2006	0	NONE	PVT	UNK		NONE	NONE			1						1	Rash	FLU3~SANOFI PASTEUR~U2273AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266319	11/08/2006	AZ	37.0	37		F	11/02/2006	2.5 hours after vaccine given, developed bronchospasm, conjunctivitis, rhinitis, sore throat. 7 hours later, developed fever, tachycardia (130), hypotension, myalgia - treated in ED with saline fluid bolus and Benadryl.				Y					Y	10/26/2006	10/26/2006	0	NONE	PUB	UNK		Pregnancy	Asthma; Environmental allergies, PCN; Sulfa			1						1	Bronchospasm; Conjunctivitis; Hypotension; Myalgia; Pyrexia; Rhinitis; Tachycardia	FLU3~SANOFI PASTEUR~U4224AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266349	11/08/2006	GA	49.0	49		F	11/02/2006	Progressively thru the night patient was feeling more achy all over body, no appetite/nausea, headache, runny nose (slight) backache. Patient was not sleeping well at 3 AM and got up to take Tylenol. Patient was so weak. Patient fell over and fainted. Had severe sweating then chills thru the night.									N	11/01/2006	11/02/2006	1		OTH	UNK	None	None				1						1	Anorexia; Back pain; Muscular weakness; Nausea; Pain; Rhinorrhoea; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0266359	11/08/2006	NE	56.0	56		F	11/02/2006	Early evening of 10/31 began to feel very fatigued. Took nap at 20:00 before coming to work that night of 10/31. When woke up at 21:00 felt very hot and bedding patient was laying on was hot. Showered then came to work. Began chills. Started the hoarseness and scratchy throat at 24:00. Has had headache often. Has taken one dose of ALEVE. No site soreness, redness or swelling.				Y					U	10/31/2006	11/02/2006	2		PUB	PVT	ADVAIR; COMBIVENT; AMARYL; HYZAAR; AVANDIA; LASIX; LEXAPRO	None	None			1						1	Chills; Dysphonia; Fatigue; Feeling hot; Headache; Pharyngolaryngeal pain	FLUX~SANOFI PASTEUR~U2212AA~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0266275	11/09/2006	IL	42.0	41		M	11/08/2006	Rash developed and swelling around wrist of both hands.									Y	11/08/2006	11/08/2006	0		OTH	OTH						1						1	Oedema; Rash	FLU3~SANOFI PASTEUR~U2192AA~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266368	11/09/2006	OR	31.0			F	11/06/2006	Information has been received from a 31 year old female nurse practitioner with chronic asthma and latex allergy who on 10/24/06 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 651318/1006P) (0.5ml), IM. Concomitant therapy that day included influenza virus vaccine (unspecified), at a different site. Subsequently, about two hours post vaccination, the pt developed local reactions at the injection site. The reactions included erythema, induration and cellulitis. She stated that she was also short of breath and required additional asthma medication. At the time of the report, the pt was recovering. The reporter considered her experience to be an other medical event (OMIC). Additional information has been requested.				Y					N	10/24/2006	10/24/2006	0		OTH	OTH			Asthma chronic, Latex allergy.		WAES0610USA13946	1						1	Cellulitis; Dyspnoea; Injection site erythema; Injection site induration	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1006P~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0266372	11/09/2006	PA				U	10/06/2005	A pt with unk medical history, had received a dose of Fluzone SV 2006-2007 USP, lot number U2273AA on an unspecified date. The route and site of administration was not reported. The day after receiving the vaccination, the pt appeared to have a severe hypersensitivity to the vaccination of pruritic allergic reaction that progressed, and actually required short hospitalization and treatment with systemic corticosteroids, etc. Diagnostic performed were not reported. Per the reporter, there were no other causes that could be determined for this, and therefore the assumption was that it was indeed due to the influenza vaccine.					Y	0			U					UNK	UNK					200602888	1						1	Hypersensitivity; Pruritus	FLU3~SANOFI PASTEUR~U2273AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0266373	11/09/2006	AL	45.0			F	10/06/2006	Seriousness criteria other medically significant (OMIC). Initial report received on 11/1/06 from a health care professional. A 45 year old female pt, with unk medical history, had received an IM injection of Fluzone SV 2006-2007 USP, lot number U2180AA, on 10/31/06. The site of administration was not reported. Four hours post immunization, the pt experienced itchy eyes and throat. Her eyes turned bright red and her face started to swell. The pt went to the ER and was treated with Solu Medrol, IV Pepcid, Benadryl, and Zyrtec. Diagnostic performed were not reported. At the time of this report, the pt was much better with only red eyes.				Y					U	10/31/2006	10/31/2006	0		UNK	UNK					200602895	1						1	Eye disorder; Face oedema; Ocular hyperaemia; Pruritus	FLU3~SANOFI PASTEUR~U2180AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266374	11/09/2006	PA	17.0	17		M	11/06/2006	Seriousness criteria other medically significant (OMIC). Initial report received on 11/3/06 from a health care professional. A 17 year old male pt had received an injection of Fluzone  SV 2006-2007, lot number U2275AA, at some time during the week of 10/23/06. Within a few minutes post vaccination, the pt experienced chest tightness, and swelling of the nose and throat. He was transported by ambulance to an ER where he was treated and released. At the time of this report, the pt had recovered.				Y					Y	10/23/2006	10/23/2006	0		UNK	UNK					200602947	1						1	Chest discomfort; Nasal oedema; Throat tightness	FLU3~SANOFI PASTEUR~U2275AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266375	11/09/2006	WA	24.0	24		F	11/07/2006	10/31/06 1530, Employee received FLULAVAL vaccine left deltoid.  11/01/06 1000, Employee woke up with redness and swelling at injection site.  11/02/2006 Employee states arm looks much worse, came in for evaluation.  Measured 50 cm X 50 cm redness, swelling and warmth at injection site.  Continued to monitor, employee states completely resolved 11/05/06. (OMIC) Per 60 day report: Total recovery. No file needed & she did not get the flu. No treatment required.									Y	10/31/2006	11/01/2006	1	none	UNK	UNK			none			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F061311~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0266376	11/09/2006	PA	60.0			M	11/06/2006	This pt my brother received Zostavax and a flu vaccine on the same visit approx 7-10 days prior to developing a stroke. The stroke by MRI MRA was a complete occlusion of his R internal carotid artery with the MCA arterial distribution affected. Risk factors were hyperlipidemia but this was well controlled with statin Zocor 40 for years. No hypertension. No diabetes. Healthy life style, occasional daily cocktail, non smoker ever. Only prior medical history otherwise was a urethral stone two or three years ago. 02/27/07-records received and reviewed for DOS 11/5-11/8/06 DC DX: cerebrovascular accident secondary to carotid dissection on the right side. hyperlipidemia. Admitted with left sided facial droopiness. He had a right internal carotid artery dissection is hole.  He still has cognitive impairment (mild), R facial droop.  He wil never be able to believe Per 60 day follow up: Pt had a right internal carotid artery dissection. He had a large R MCA stroke. He has regained most use of left hand. He still has a large left lip droop. He has difficulty with speech, of math calculations and difficulty concentrating.			Y	Y					N		11/05/2006		Normal lab. Normal vital signs. MRA/MRI findings above for complete R internal carotid artery occlusion involving an MCA stroke.  CXR: Normal, MRA of brain acute infarct in the distribution of right middle cerebral artery. MRA of carotids impaired flow in right internal carotid artery. Repeat MRA showed improved flow. CT cineangiography showed dissection of right middle cerebral artery with intact blood flow. EEG abnormal slow activity on right. Sylvian area is consistent with recent right middle cerebral artery distribution stroke.	UNK	UNK			No hypertension, no diabetes no comorbidities except for hyperlipidemia well controlled with statin Zocor therapy for years.			1						1	Carotid artery occlusion; Cerebrovascular accident; Cerebrovascular accident; Nuclear magnetic resonance imaging brain abnormal	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Life Threatening	Influenza
0266378	11/09/2006	MN	12.0	11		F		Tired, Lethargic, dizzy, headache, weak, fever, cough, nausea. Temp of 103F, pale/peaked. Note from Nursing Supervisor. Child was vaccinated on a Thursday and came to school on Friday. She was absent on Monday and Tuesday of the following week but returned to school on Wednesday. The school nurse did not see the child in the shcool health office. As far as the school nurse and public health know, the child was never taken in to see a doctor for any complaints that were listed by the reporter. History includes suspected Beckers Muscular Dystrophy. Father has it.								Y	Y	10/26/2006				UNK	OTH						1						1	Asthenia; Cough; Dizziness; Fatigue; Headache; Lethargy; Nausea; Pallor; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500437P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Disabling	Influenza
0266379	11/09/2006	CT	66.0	66		M	11/01/2006	Within 15 minutes of receiving flu and Pneumo shots at flu clinic pts did not feel well, was seated I went to him, he stated he felt some numbness on left side of face, no pallor, no difficulty breathing. I gave him smelling salts and took his BP 195/101 pulse 68, Pt admitted he did not take BP med that am. He sat for 1/2 hour longer and wife administered BP med. Pt was oriented, not confused. Advised him to call MD ASAP and they left. DC DX: probable transient ischemic attack with left facial and hand numbness resolved. poorly controlled hypertension dilated ascending aorta with mild aortic insufficiency and aortic valvular sclerosis and left ventricular hypertrophy with normal left ventricular ejection fraction. Repeat echo via transesophageal echocardiogram showed no cardiac source of emboli. Mild aortic regurgitation with mild aortic vale thickening. Trace tricuspid and mitral regurgitation. Normal LV/RV size and function. Pulmonary artery of normal size. Ascending aorta/root is normal in size. Dyslipidemia Anxiety History of Lyme Disease not presently active Palpitations. BP on admission 190/93. Neurologic exam 5/5 bilateral upper and lower extremities. Cranial nerves 2 through 12 grossly intact other than decreased sensation on left side initially. Per 60 day follow up: I have received no further information regarding this patient.					Y				Y	11/01/2006	11/01/2006	0		PUB	PVT	Did not take BP med this am					1						1	Blood pressure increased; Cardiac failure; Hypertension; Hypoaesthesia; Transient ischaemic attack	FLU3~SANOFI PASTEUR~2194AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1049P~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0266380	11/09/2006	TX	69.0	69		F	11/08/2006	Hot, red, swollen on 11-07-06. Swollen part in lower arm. Inside of elbow still today (11-8-06) still not as bad. Take 50mg of Benadryl tonight.									U	11/07/2006				OTH	PVT		None				1						1	Erythema; Feeling hot; Swelling	FLU3~SANOFI PASTEUR~U2178AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0486F~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266382	11/09/2006	KY	1.0	1	.0	M	11/08/2006	Development of fever 105 and maculopapular circular rash over site of vaccinations 7 days after immunizations.				Y					N	10/30/2006	11/08/2006	9	None	PVT	PVT	None	None	None			1						1	Pyrexia; Rash macular	FLU3~SANOFI PASTEUR~U2243AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~AC21B05AA~3~IM~LL~HIB (PEDVAXHIB)~1|MMRV~MERCK & CO. INC.~0815F~1~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08646H~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0266386	11/09/2006		66.0	66		F	10/27/2006	flu & pneumoccal vaccine given on 10/24 at 2pm. Patient experiencing flu like symptoms on Wednesday (febrile, chills, sweats). Patient woke up Thursday with temp 101F and redness , increased swelling on arm-pain 7/10. Area 10x12cm, general malaise, feeling slightly better Friday. Afebrile.				Y					Y	10/24/2006	10/25/2006	1	None	PVT	PUB	Cozan 50mg, Diazide, Detrol LA	None	Hypertension, allergies: Iodine			1						1	Influenza like illness; Malaise; Pain; Pyrexia; Swelling	FLUX~SANOFI PASTEUR~K12~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0486F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0266387	11/09/2006	TX	52.0	51		F	11/05/2006	Patient complained of throat closing up, burning eyes, wheezing, no rash after leaving clinic at night. Patient states was doing fine next AM. Patient declined to return to clinic.									Y	11/01/2006	11/01/2006	0		PVT	PVT			Penicillin, sulfa			1						1	Lacrimation increased; Throat tightness; Wheezing	FLU3~SANOFI PASTEUR~U2202AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266388	11/09/2006	MT	16.0	16		M	10/31/2006	Swollen 50 degrees, warm, painful									Y	10/30/2006	10/31/2006	1	None	PUB	UNK	Concerta, Zoloft	None	Depression, Attention-deficit hyperactivity disorder.  Dust, weed and penicillin allergy.			1						1	Feeling hot; Pain; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70278~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266389	11/09/2006	TN	37.0	37		F	11/03/2006	Urticaria. Given Deponedrol 80 mg, oral Prednisone and hydroenyzme.									Y	10/23/2006	10/24/2006	1		PVT	PVT		None	Diphenhydronias allergy, history of hypothyroidism with goiter.			1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69897~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266391	11/09/2006	NY	65.0	65		M	11/04/2006	Extreme chills/sweating. Fatigue. Severe aches in most joints. Some joint swelling. No nausea. Bedridden 6 days. Headache. Intermittent fever 101.									Y	10/23/2006	10/23/2006	0		OTH	PVT	Altace 5mg daily, Fosamax 70mg weekly	None	None			1						1	Arthralgia; Chills; Fatigue; Headache; Hyperhidrosis; Joint swelling; Pyrexia	FLU3~SANOFI PASTEUR~U2213AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266392	11/09/2006	ME	60.0	60		M	11/03/2006	10/24 pain and warmth developed in right arm. 10/25 rash appears on right hip and leg. 10/26 rash spreads to left hip and leg resolving on right side some what. 10/30 wife calls to inform of rash. 11/1 rash resolved arm still tender.									Y	10/24/2006	10/24/2006	0	None	PVT	PVT	Bactrim SS, Coumadin, Folic Acid, Fosamax, Fosomax, Gamunex, hydroxychloroquine, itraconazole, Kcl slow release, Motrin, Nexium, Prednisone	no illnesses at this time but has had dermatomyositis and fevers/lymphadenopathy.	None			1						1	Feeling hot; Pain; Rash; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA210AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0674F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266393	11/09/2006	MI	13.0	13		M	10/31/2006	Headache, vomited x 1, swollen and red right arm.				Y					Y	10/27/2006	10/29/2006	2		PVT	UNK		None				1						1	Erythema; Headache; Swelling; Vomiting	FLU3~SANOFI PASTEUR~U2178AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1922AB~UNK~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B009BA~UNK~IM~RA~TDAP (BOOSTRIX)~1	USA	Emergency room visit	Influenza
0266395	11/09/2006	CA	8.0	7		M	11/08/2006	Had flu vaccine at approx 9:30am 11/6/06 and developed severe headache at 4pm, which lasted 36 hours. No prior history of headaches.									Y	11/06/2006	11/06/2006	0	None	PVT	PUB	Risperdal	None	atymial autistic features, mild CP			1						1	Headache	FLU3~SANOFI PASTEUR~U2193AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266416	11/09/2006	SC	57.0	57		F	11/09/2006	Aching in legs, weakness, numbness, shortness of breath, admitted to hospital 10/31/06.  11/21/06 Received medical records from hospital which reveal patient admitted 10/31/06 for progressive generalized weakness which began 10/29 associated with paresthesias & progressive gait disorder. Patient admitted for further w/u to exclude cord compression. There was no obvious muscle weakness on exam of 11/1 & it was felt that patient had quickly resolved GBS.  She was D/C at that time.  Patient was readmittted on 11/2/06 with dx of GBS & respiratory failure.  Noted to have phrenic nerve involvement requiring bipap support after being seen with SOB. Treated with plasma exchange x 5 & improved well.  D/C to home 11/7/06 PMH: asthma, obesity, HTN, osteoporosis, restless leg syndrome. Final DX: GBS w/respiratory failure, resolving./ss					Y	7			Y	10/27/2006	10/29/2006	2	LABS: EMG/NCS reported by neurologist as WNL (no report included).  MRI of complete spine revealed degenerative changes with multilevel spinal stenosis & small disc protrusions at C3-4, T9-10 & T11-12.	PVT	PVT	Flovent, Xopenex, Singulair		Allergic rhinitis, asthma, allergic PCN, Codeine, Avelox.			1						1	Asthenia; Dyspnoea; Gait disturbance; Guillain-Barre syndrome; Hypoaesthesia; Pain; Paraesthesia; Respiratory failure	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71639~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0266418	11/09/2006	MI	75.0	74		F	11/09/2006	10/21/2006 Pt c/o redness, warm, swelling from shoulder down to wrist left arm. Resolved by 10/25/06, Denies hives or dyspnea.									Y	10/20/2006	10/21/2006	1	Pt called 11/09/06 to report.	PUB	PVT	Procardia, Altace, Evista Miacalcin spray		Arthritis			1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70277~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1047P~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266419	11/09/2006	NJ	56.0	55		F	10/30/2006	10/26/2006 pt gripping sensation in stomach, 1/2-1 hour duration 24 hours after inoculation, site of injection warm, tender and edematous. Pts normal temp 98.6, her temp 99.2. Pt c/o skin tender to touch, muscle and body aches 4 hours.									Y	10/25/2006	10/26/2006	1		PUB	PVT	Effexor, Verapamil, Crestor, Vitamin	NONE	Allergic sulfa and mycins (all) latex bandaid		NJ200607	1						1	Abdominal pain; Injection site oedema; Injection site warmth; Myalgia; Pain; Pyrexia; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70739~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266420	11/09/2006	NJ	60.0	59		M	12/12/2006	Patient has nasal congestion, legs feel achy. Patient shuffled as he walked, generalized pain. Saw Dr 10-12-06 patient complained of severe constant muscle ache in calves or legs. Patient had difficulty sleeping last night.									Y	10/10/2006	10/11/2006	1	None	PUB	PVT		None				1						1	Insomnia; Myalgia; Nasal congestion; Pain; Restless legs syndrome	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~07278~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266421	11/09/2006	MD	9.0	8		M	11/09/2006	Developed wheezing. Seen in private physicians office and treated with Xopenex nebulization on11/7/06 and cleared on 11/8/06 visit of wheezing.				Y					Y	11/02/2006	11/06/2006	4	None	PUB	PUB	None	None				1						1	Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500439P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0266423	11/09/2006	MO	53.0	53		F	11/09/2006	On 11/7/06 presented to Employee Health office reporting weakness in left arm since vaccination received. Denies pain. No localized, heart, redness, swelling. Denies fever.									U	10/17/2006	10/17/2006	0		PVT	PVT						1						1	Muscular weakness	FLU3~SANOFI PASTEUR~U2257AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266425	11/09/2006	CA	44.0	43		M	11/09/2006	Hives. Red, bumps to back, chest, neck, arms, started 11:30 in AM today. Swelling, redness and itching to Left eyelid started 11/07/06 at 16:30. Diagnosed-stye to Left eye, possible allergic reaction				Y					Y	11/07/2006	11/07/2006	0		PUB	PUB	Seizure med	None	Seizures			1						1	Erythema; Eye irritation; Hypersensitivity; Pruritus; Swelling; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71210~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0266427	11/09/2006	UT	9.0	9		F	11/09/2006	Complained of hives developing on face around eyes about 2-4 hours after Influenza vaccination. Parent called in report but didn't want to bring patient into clinic for evaluation.									U	11/07/2006	11/07/2006	0	None	PVT	UNK	Unk	None	Latex allergies			1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70868~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266434	11/09/2006	NY	63.0	63		F	11/09/2006	Patient reported developing swelling and redness of right arm and glands under the arm.  Patient stated that it was difficult and painful to raise her arm.  Patient stated she used ice packs and antibiotic cream on her arm with some improvement in symptoms.									U	10/25/2006	10/27/2006	2	None	UNK	UNK	Unknown	None	Unknown			1						1	Erythema; Pain; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70739~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1040P~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266437	11/09/2006	WI	70.0	70		F	11/09/2006	2-3 hours post vaccination pain in L axillary area then continued with redness and swollen.  ROM is decreased.  Cannot pick up anything with that arm.				Y					U	11/07/2006	11/07/2006	0	none	UNK	UNK	no	no	PCN allergy			1						1	Erythema; Joint range of motion decreased; Pain; Swelling	FLU3~SANOFI PASTEUR~U2192AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0302F~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0266438	11/09/2006	IL	48.0	48		F	11/09/2006	Cellulitis at site- placed on Omnicef 300mg BID									Y	10/28/2006	10/29/2006	1		UNK	UNK						1						1	Cellulitis; Injection site reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70741~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266439	11/09/2006	CO	3.0	3		M	11/09/2006	Patient was inadvertently given the influenza vaccine adult formulation to be used for age 18 yrs and over.  Parent of child notified on same day after we contacted the vaccine manufacturer.  We informed parent of possible side affects to watch for, such as increase pain, redness, swelling, fever,headache, cough, sore throat.  Parent instructed to call back immediately to the office if they observe any of the symptoms.									U	11/08/2006	11/08/2006	0	Per manufacturer instructions, no need to repeat flu vaccine dose.  No other instructions given other than to watch for the above mentioned symptoms.	UNK	UNK	none	no	allergic to Omnicef			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601711~1~IM~RL~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0266440	11/09/2006	MS	0.0			F	11/09/2006	Administerd Flu Vaccine in R Deltoid 11/6/2006; Presented with swelling under groin area of R arm 11/7/2006; Afebrile; Denied Tenderness @ swollen Area. Private MD visit 11/8/2006. Rx Valtaren SR				Y					Y	11/06/2006	11/07/2006	1		UNK	UNK		Denied	Denied		MS06013	1						1	Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA215AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0266441	11/09/2006	WY	54.0	54		F	11/09/2006	C/O weakness, dizzyness, nausea, and heart pounding ~30 minutes after shot given.  Shot was given at outside clinic.  Client presented to Public Health office 2 hours later were PHN took vitals.  BP and Pulse above normal range.  Advised to see Primary MD.				Y					Y	11/07/2006	11/07/2006	0	BP 166/88 P 104	UNK	UNK	None	None	Was told heart beat is irregular several years ago.			1						1	Asthenia; Dizziness; Heart rate increased; Hypertension; Nausea; Palpitations	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71639~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0266442	11/09/2006	MD	49.0	49		F	11/09/2006	Received vaccine on 11/7/06 woke up the next morning on 11/8/06 with Hives over entire body. She took Benadryl and they started to resolve. Instructed to call PCP is symptoms worsened. Denied Shortness or breath.									Y	11/07/2006	11/08/2006	1		UNK	UNK						1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71830~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266443	11/09/2006	CA	61.0	61		F	11/09/2006	hives, pain, and swelling at site.  systemic fatigue reported as well.				Y					U	11/06/2006	11/06/2006	0		UNK	UNK						1						1	Fatigue; Injection site pain; Injection site swelling; Urticaria	FLU3~SANOFI PASTEUR~u2252~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0619F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0266444	11/09/2006	IN	59.0	49		F	11/09/2006	8:50 - c/o dizziness. Diaphoretic. BP 168/92 P 96 RR 16 Blood sugar - 65. Benadryl 50 mg given. Capri Sun given to drink. 9:00 BP 142/74 P 96 RR 16 9:05 142/70 - given animal crackers to eat 9:10 140/72 BS - 78 9:25 138/70 P 80 9:40 140/74 10:15 to Hospital for exam				Y					Y	11/09/2006	11/09/2006	0		UNK	UNK						1						1	Dizziness; Hyperhidrosis; Blood glucose decreased; Blood pressure increased; Dizziness; Hyperhidrosis; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601311~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601311~UNK~~LA~INFLUENZA (SEASONAL) (FLULAVAL)~2	USA	Emergency room visit	Influenza
0266445	11/09/2006	CA	47.0	47		F	11/09/2006	After flu shot on 10/23/06, she had sore arm and fever of 100F come and go, coughs and hoarse voice. She was sick up to today 11/9/06. Doctor gave her sick leave and put her on Z-pack.									N	10/23/2006	10/25/2006	2	Upper Respiratory Infection No lab test done	UNK	UNK		No	Hypertension			1						1	Cough; Dysphonia; Pain; Pyrexia; Upper respiratory tract infection	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71641~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266446	11/09/2006	IN	46.0	0	.0	F	11/09/2006	8:50 AM - c/o dizziness. Diaphoreic. BP178/110 P 72  RR 12. Blood sugar 51. Benadryl 50 mg given along with Capri Sun. 9:00 152/94 P 72 RR 12 9:05 156/90 P 72 RR 12 Given animal crackers to eat 9:10 134/78 P 72 RR 12 Blood sugar 74 9:25 116/58 P 72 RR 12 Feeling a little better, but still weak and dizzy 9:40 132/62 c/o nausea 10:15 To Hospital for exam				Y					Y	11/09/2006	11/09/2006	0		UNK	UNK						1						1	Asthenia; Blood pressure increased; Dizziness; Hyperhidrosis; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601311~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0266447	11/09/2006	GA	56.0	56		F	11/09/2006	Received vaccination at apporximately 11:45; onset of symptoms was approximately 12:06pm.  Symptoms:  Diaphoretic, whoozie, slurred speech.  Was diagnosed in the hospital with a large hemorrhagic CVA and was vented due to respiratory distress. 12/21/06 Received medical records from hospital which reveal patient hospitalized 11/6/06-11/27/07.  Consults by neuro neurosurg, pulm, cardio, endocrin and GI.  Intubated in ER.  Developed aspiration pneumonia.  PEG feeding tube placed until extubated & able to tolerate puree diet.  Transferred to Rehab facility on 11/27/06 & d/c to home on 12/5/06. Final Dx: Intracranial hemorrhage in right basal ganglia; HTN; hypothyroid; and hypokalemia. Patient out come unknown; Please contact the family for any future updates.  Per 60 day follow up: Does not know the current status of the patient.							Y		U	11/06/2006	11/06/2006	0	Unknown	UNK	UNK	UNKNOWN	UNKNOWN	UNKNOWN PMH: HTN & hypothyroidism			1						1	Cerebrovascular accident; Dizziness; Dysarthria; Haemorrhage intracranial; Hyperhidrosis; Hypertension; Hypokalaemia; Hypothyroidism; Pneumonia aspiration; Respiratory distress	FLU3~SANOFI PASTEUR~U2217AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0266450	11/09/2006	IA	65.0	65		F	10/30/2006	Day after receiving flu vaccine, I broke out in hives and had uncomfortable itching.  The following day I took an Alavert tablet, and the itching stopped in about 45 minutes.  Itching did not return.									Y	10/30/2006	10/31/2006	1		UNK	UNK						1						1	Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0266451	11/09/2006	MN	7.0	7		F	11/09/2006	Patient was administered an adult dose (0.5ml) of flu vaccine not indicated for patients under 18 years of age. No adverse affects were observed. Patient's mother was informed that no 2nd dose was required. CDC was notified.									U	11/06/2006	11/06/2006	0	N/A	UNK	UNK		NA	NA			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F600911~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0266452	11/09/2006	MN	5.0	5		M	11/09/2006	Patient was administered an adult dose (0.5ml) of flu vaccine not indicated for patients under 18 years of age. No adverse affects were observed. Patient's mother was informed that no 2nd dose was required. CDC was notified.									U	11/06/2006	11/06/2006	0	NA	UNK	UNK						1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F600911~1~IM~LL~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0266453	11/09/2006	WA	30.0	30		F	11/09/2006	Got flu shot and with in 6 - 8 minutes of injection, my throat started tightening up.  I started itching all over and developed rash starting on upper extremities, chest and stomach.  I became very dizzy and hot.   Has received flu shot for the last 12 yrs without incidence.   Was laid on back and elevated legs.  Received benadryl and prednisone.  Monitored B/P. Recovered fully. No health changes since receiving last flu shot.									Y	10/17/2006	10/17/2006	0		UNK	UNK	Refuses to list	None	none			1						1	Dizziness; Feeling hot; Pruritus; Rash; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA232AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0266454	11/09/2006	MN	7.0	7		F	11/09/2006	Patient was administered an adult dose (0.5ml) of flu vaccine not indicated for patients under 18 years of age. No adverse affects were observed. Patient's mother was informed that no 2nd dose was required. CDC was notified.									U	11/06/2006	11/06/2006	0		UNK	UNK						1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601311~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0266455	11/09/2006	MN	8.0	8		M	11/09/2006	Patient was administered an adult dose (0.5ml) of flu vaccine not indicated for patients under 18 years of age. No adverse affects were observed. Patient's mother was informed that no 2nd dose was required. CDC was notified.									U	11/06/2006	11/06/2006	0		UNK	UNK						1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601311~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0266456	11/09/2006	GA	65.0	65		F	11/09/2006	Patient describes left arm as being very sore and difficult to move. No longer constant pain, but unable to sleep comfortably. Patient states that she has a history of left shoulder injury. Has been using a heating pad. Advised to see personal MD									Y	11/03/2006	11/04/2006	1		UNK	UNK						1						1	Joint range of motion decreased; Pain; Sleep disorder	FLU3~SANOFI PASTEUR~U2244AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1007P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266458	11/09/2006	SC	47.0	47		F	11/09/2006	Occurred within 6 hours and continue to occur 2 days later. Fever of 102 degrees, Chills, Nausea, Dizziness, Joint Pain, Loss of appetite, Vaccine site inflammation (muscle pain, swelling). Treated with asprin, tylenol, lots of fluid				Y					U	11/07/2006	11/07/2006	0		UNK	UNK	none	none	none			1						1	Anorexia; Arthralgia; Chills; Dizziness; Injection site inflammation; Myalgia; Nausea; Pyrexia; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0266459	11/09/2006	NJ	1.8	1	.8	F	11/09/2006	Fever Tm104.9 today; generalized tonic-clonic seizure lasting <5minutes; ended spontaneously; seen in emergency room and discharged home.  11/28/06 Received medical records from ER which reveal patient presented with fever 104.9 & seizure lasting approx 30 sec then was post ictal.  When examined in ER she had recovered & had no further seizure activity & after observation was d/c to home. Birth HX: WNL.  delivered full term via c section, 7 lbs. Normal development.  No hx of seizures in patient or family members. Final DX: febrile seizure w/o evidence of infection./ss				Y					Y	11/08/2006	11/09/2006	1	None	UNK	UNK	None	None	None			1						1	Febrile convulsion	FLU3~SANOFI PASTEUR~U21751A~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266460	11/09/2006	VA	57.0	57		F	11/09/2006	Patient's husband reports that she received the flu shot on 10/25/06. On 10/31/06 went to the ER with severe pain in neck and shoulders with some limited movement to upper extemities.  Pain was the major presenting SX.  Patient's husband reports that patient was given a DX of pinched nerve or something like that.  Patient was given Vicodin and Ibuprofen and sent home.  Within 1 to 2 hours after arriving home, patient had complete paralysis.  Patient was able to talk and had no breathing difficulties, but could not move her upper or lower extemities.  Patient was transported to ER via 911 where she remains at the time of this report.  Some improvement has been reported at the time of this writing.  Pt is able to move her L arm and leg. Pt is able to wiggle toes and fingers on the right side.  Pt has no bowel or bladder function. Dx is Transverse Myelitis.  1/2/07 Received medical records from REHAB hosital which reveal patient admitted 11/8/06-11/29/06 with a 3 day history of progressive numbness & weakness of extremities.  Treated w/steroids, PT/OT & antibiotics.  Consults by ID, neuro & PMR PMH: hypothyroidism FINAL DX: cervical cord transverse myelitis; tetroplegia w/Brown Sequard syndrome; hypothyroidism; neurogenic bowel & bladder, resolved; low grade fever; c diff colitis; & strep & yeast UTI, resolved. 2/1/07 Received medical records from first hospital which reveal patient admitted 11/1-11/8/06 after experiencing bilateral arm & leg weakness to the point that she could not walk.  Two days prior to admit, had been helping to move furniture when felt pain in neck spreading to shoulder & weakness into her right arm.  Seen at urgent care center & received pai meds.  When leaving center, legs became weak to the point could not walk.  Ambulance called & taken to ER.   Admit exam revealed right arm strength of 0, left arm movement only from elbow down.  Right leg strength 0 & left leg can flex from knee down.  Having urine & bowel problems requiring enemas & Foley cath. Neuro & neurosurg consults done.  Tx w/5 days of high dose steroids which provided improvement but patient was still unable to walk.  PT/OT started. Transferred to rehab hospital, to f/u w/neuro & neurosurg & to repeat MRI of c spine in 6-8 weeks. FINAL DX: Transverse myelitis with right sided paralysis & left sided weakness; DJD in cervical spine; & history of hypothyroidism.			Y							10/25/2006	10/31/2006	6	Reportedly had x-rays, brain scan and a high contrast scan. 11/1-11/8 LABS: MRI of c spine showed white matter changes, contusion vs inflammation & DJD.  Hct 36. Chem WNL.  EKG sinus brady.  MRI of brain was WNL.  MRI of c spine revealed white matter inflammation at C2-3 level & DJD changes at C5-6 level. 11/8-11/29 LABS: MRI or c spine revealed white matter changes with transverse myelitis from C2-C7 (lesion was about 2.9 cm in greatest height)  with increase in cervical cord size.  There was also cervical spondylosis w/disk bulging at C2-3, C4-5 & C6-7 but this was felt to be noncontributory.  MRI of head showed few scatter foci with nonspecific gliosis in the white matter.  MRA of head was WNL.	UNK	UNK	Synthroid	None	Allergies for unspecified amount of time. Allergy shots-had one 1 week prior to flu vaccine. PMH: hypothyroidism.			1						1	Joint range of motion decreased; Myelitis transverse; Neck pain; Nerve compression; Paralysis; Shoulder pain	FLU3~SANOFI PASTEUR~U2256AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0266461	11/09/2006	DC	0.0	57		F	11/09/2006	Patient received vaccine afternoon and woke the next morning with decreased mobility and pain.  Unable to sleep due to pain.  Went to personal physicain who DX patient with tendonitis due to the flu shot.  Taking Aleve with good results.  Mobility improving and pain diminishing.									Y	10/31/2006	11/01/2006	1		UNK	UNK	Avodart, thyroid, statin drug, antihypertensive.	None	None			1						1	Hypokinesia; Insomnia; Pain; Tendonitis	FLU3~SANOFI PASTEUR~U2213AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266462	11/09/2006	WA	15.0	15		M	11/09/2006	Tonic posturing 1-2 seconds following administration of Tdap vaccine, 1 minute following Influenza vaccine.  Tonic upper extremity posturing lasted approximately 20 seconds, with full resolution of symptoms.				Y					Y	11/09/2006	11/09/2006	0	Capillary glucose 139	UNK	UNK	None	None	None			1						1	Posturing	FLU3~SANOFI PASTEUR~U2274AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B009BA~1~IM~RA~TDAP (BOOSTRIX)~1	USA	Emergency room visit	Influenza
0266463	11/09/2006	FL	36.0	36		F	11/09/2006	TWO DAYS AFTER ADMINISTRATION OF LIVE NASAL FLU VACCINE, DEVELOPED ITCHING, SUBSEQUENT EXTENSIVE URTICARIAL REACTION LASTING SEVERAL WEEKS INCLUDING ANGIOEDEMA OF FACE AND LIPS. MR received. Patient received Flumist on 10/10/2006.  On 10/12/2006 began experiencing hives which continued several weeks.  First sought treatment on 11/01/2006 for urticaria which was treated with Zyrtec, a Methylprednisolone dose-pak and Cimetidine.  On 11/07/2006 she sought treatment for facial swelling and continued hives. Swelling of lips and cheeks were noted, no stridor. Assessment:  Urticaria with angioedema. Prednisone taper. F/U on 11/09/2006 with hives decreasing, but still having itching. Assessment: Urticaria/angioedema likely 2' to live flu vaccine, improving.				Y					Y	10/10/2006	10/12/2006	2	NONE	UNK	UNK	Meds: Topamax, Ambien CR, Effexor XR, and Axert.	NONE	PMH: migraine H/A, tension H/A, post-partum depression, major depression, panic disorder, insomnia, ADHD, and thalassemia trait.  Allergies: Verapamil, oral contraceptives, Stadol.			1						1	Angioneurotic oedema; Pruritus; Swelling face; Urticaria; Vaccination complication	FLUN3~MEDIMMUNE VACCINES, INC.~UNKNOWN~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0266464	11/09/2006	TX	40.0	40		F	11/09/2006	swollen, red, itchy injection site, swelling, pain in arm, chest tightness, head ache, slight swelling of tongue.  Give Benadryl and albuterol									Y	11/09/2006	11/09/2006	0		UNK	UNK	avapro, advair	getting over a cold	ppv, aspirin, aloe vera, ace inhibitors, asthma			1						1	Headache; Injection site erythema; Injection site pain; Injection site reaction; Injection site swelling; Pruritus; Tongue oedema	FLUX~UNKNOWN MANUFACTURER~?~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0266468	11/09/2006	NC	5.0	5		F	11/08/2006	Patient recieved FluMist at approximately 11:30am with no complaints. While at lunch the patient comlained of something in his throat and began to gag himself, Mom thought something could be caught in his throat but after drinking fluids the sensation began to get worse.  She returned to the office for him to be examined.  On exam he was noted to be in no acute distress.  He did have pallor, have slight tonsilar hypertrophy, swollen mucous membranes with clear rhinorrhea. Chest exam was clear. Paient reported tingling sensation in tongue and throat, with throat feeling funny. He was noted to be swallowing with mild difficulty.  He was given a dose of epi IM and po Atarax.  Symptoms improved in 30 minutes.  MR received/, revealing a well child exam of 10/03/2006. Only c/o is seeing spots for which he was given a referral. Child returned 11/08/2006 for c/o intermittant diarrhea x 2 weeks. FluMist given.  One hour later child returned with c/o throat closing and trying to gag himself by putting fingers in throat. Exam:  pale panic appearance, turbinates swollen with clear d/c, lungs clear. Txd with Atarax and epinephrine IM. Symptoms resolved in 30. Impression: Anaphylactic reaction to FluMist.				Y					Y	11/08/2006	11/08/2006	0		UNK	UNK	N/A	Gastroenteritis (diarrhea),	Cat dander; hypoglacemia			1						1	Anaphylactic reaction; Dysphagia; Hypertrophy; Mucous membrane disorder; Paraesthesia; Retching; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500438P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0266470	11/09/2006	MD	36.0	36		F	11/09/2006	NONE									U	11/03/2006			N/A	UNK	UNK		NONE	NO KNOWN ALLERGIES			1						1	Medication error	DTAP~SANOFI PASTEUR~C2489AA~1~IM~RA~DTAP (DAPTACEL)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71828~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266012	11/10/2006	CA	60.0	60		M	11/07/2006	A 60 year old male pt had received a first dose, left deltoid injection on Fluzone SV 2006-2007, lot number U2240AA, on 10/05/2006. On the same day, the pt felt ill and went to an ER. He was hospitalized for respiratory problems/infection and died on an unk number of days shortly afterwards. Past medical history was not reported. It was not known whether the pt had any illnesses at the time of vaccination. The exact date of death was not reported.	Y				Y	0			N	10/05/2006	10/05/2006	0		OTH	PVT					200602965	1						2	Respiratory disorder; Respiratory tract infection; Infection; Malaise; Respiratory disorder	FLU3~SANOFI PASTEUR~U2240AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2240AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0266466	11/10/2006	CA	40.0	40		F	11/10/2006	I got a flu shot on Tuesday afternoon and it hurt worse than normal, it was an intense stinging sensation rather than the mild burning sensation I've gotten from previous flu shots. Within 3 hours I was very sore & achy, which I expected, and I took some ibuprofen. Within 3 more hours I was in more pain than I could believe. It was like I had electricity running through my entire body and a hangover at the same time and then got hit by a truck on top of it. Every single joint and musle was painful -- beyond sore and achy to excruciating pain! At one point I told DH that even my teeth and hair hurt. I slept fitfully & feverishly all Tuesday night and then all day Wednesday! I'm feeling better Thursday but I still have a couple of areas that still feel like they have a charge to them. I have never had any reaction to any vaccine or any medication before.									Y	11/07/2006	11/07/2006	0	Hospital did not seem interested in pursuing this because it was not an allergic reaction. I was also told that the two glasses of wine I'd had that evening could have had an adverse reaction with the ibuprofen.	UNK	UNK	Prenatal vitamins (we're trying to conceive but I'm not pregnant at this time.)	None	None			1						1	Injection site pain; Insomnia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0266472	11/10/2006	LA	24.0	24		M	11/07/2006	Seriousness criteria other Medically significant (OMIC). A 24 year old male pt with a history of asthma and allergy of Vicodin received doses of YF Vax, influenza vaccine (Manufacturer unk), Hepatitis A vaccine (manufacturer unk), Hepatitis B vaccine (manufacturer unk), and Typhoid vaccine (manuf unk), in mid October 2006. The lot numbers were reported as unk. The routes and dates of administration were not reported. As per the reporter, all of the vaccines except for the YF Vax were administered at another facility. Approx two days after receiving the vaccines, the pt complained of a general headache, right pupil enlargement and blurred eyesight in his right eye. The pt used a scopolamine patch approx six to seven hours after the pupil changes were noted. He was evaluated at an emergency room, where he was diagnosed with possible meningitis ore questionable mild encephalitis. An MRI and CBC chemistry were all neg. The condition resolved and the pt recovered from the events.				Y					Y	10/01/2006				UNK	UNK	Scopolamine Patch		The patient has a history of asthma.  He has a possible allergy to VICODIN.  It is unknown whether he experienced any adverse events following prior vaccination.  The patient denied any illness at the time of vaccination.		200602905	1						1	Encephalitis; Headache; Meningitis; Mydriasis; Vision blurred	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~UN~HEP A (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~UN~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|YF~SANOFI PASTEUR~~UNK~~UN~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0266481	11/10/2006		65.0			M		A report was received from a health care professional concerning a 65 year old male vaccinee. The vaccinee has a past medical history of gastric banding, and a current history of coronary artery disease,d congestive cardiac failure, Type II Diabetes mellitus and kidney stones. Concomitant medications included Altace, Coreg, Elavil, Keflex, Lasix and Potassium. The vaccinee had received Influenza vaccine in the past with on adverse effects. On 10/17/06 the vaccine received influenza vaccine (Brand unspecified) in his right shoulder and pneumococcal 23 v polysaccharide vaccine in his left shoulder. Within 3 hours the vaccinee developed localised pain in his left arm and shivering. An hour later he had sluggish speech and was confused. He was taken to the ER with a systolic blood pressure of 129 and saturated oxygen at 100%. He was confused, had slurred speech and severe shivering and was treated with oxygen and a warm blanket. The vaccinee had severe left shoulder pain, especially with movement, with a heavy sensation in the arm. The physician indicated that blood test including cardiac enzymes were performed, and that the events did not appear to be cardiac related. The vaccinee was not able to raise his arm but was able to move his fingers, there was severe pain with passive movement of the arm. Additional vital signs included systolic blood pressure 109, pulse 55, temp 97.1. Hospital transfer for further evaluation, treatment and possible hospital admission were being considered at the time of the report. The reporter considered the events to be serious, immediately life threatening and in important medical event (OMIC).			Y							10/17/2006	10/17/2006	0		UNK	UNK	Altace, Coreg, Elavil, Keflex, Lasix, Potassium.		Gastric banding, Coronary artery disease, congestive cardiac failure, Type II diabetes mellitus, kidney stone. Previous exposure to influenza vaccines, with no adverse effects.		CVOX200600553	1						1	Chills; Confusional state; Dysarthria; Hypokinesia; Hypoxia; Injection site pain; Sensation of heaviness; Shoulder pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1044F~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening	Influenza
0266488	11/10/2006	MD	54.0	54		F	11/10/2006	Severe pain and redness/heat at site, fever, nausea, headache, body aches.									U	11/07/2006	11/08/2006	1		UNK	UNK		None	Diabetes, asthma			1						1	Headache; Injection site erythema; Injection site pain; Injection site warmth; Nausea; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266490	11/10/2006	MO	40.0	40		F	11/10/2006	Around 4:45 pm - Difficulty breathing, I couldn't seem to take a deep breath, and also little faint - lasted about 15 minutes - no treatment, because I was driving home from work during the time.  It was scary to the point of me almost pulling over to the side and pressing my ONSTAR button for assistance, but I let my windows down and kept on driving.									Y	11/03/2006	11/03/2006	0		UNK	UNK	NONE	NONE	Asthma, Allergic to Penicillin, Allergic to Ragweed	Difficulty Breathing~Influenza (Seasonal) (no brand name)~1~0.00~In Patient		1						1	Dyspnoea; Syncope	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0266491	11/10/2006	WI	12.0	12		M	11/10/2006	11/8/2006 EVENING, FIRST NOTICED RED, SWOLLEN, LUMP AT INJECTION SITE. SLIGHTLY WARM. HURTS TO LIFT ARM. REDDENED AREA IS 2X1.  DOESN'T ITCH.									Y	11/08/2006	11/08/2006	0		UNK	UNK			PENICILLIN			1						1	Hypokinesia; Injection site erythema; Injection site mass; Injection site swelling; Pain	FLU3~SANOFI PASTEUR~U22122AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266492	11/10/2006	CT	44.0	44		F	11/10/2006	Acute pain all the way down the R arm (ulnar nerve) in which the vaccine was administered. Pain was followed by numbness for approximately 12 hours. Also, acute nausea and gagging, sick to stomach for over 24 hours.									Y	11/06/2006	11/06/2006	0		UNK	UNK	no	no	no			1						1	Hypoaesthesia; Nausea; Pain; Retching	FLU3~SANOFI PASTEUR~U2197AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266495	11/10/2006	MO	61.0	61		F	11/10/2006	Employee alleges bilateral blepharedema, along with swelling of lips. C/O slight chest tightness but no frank shortness of air. Employee did not seek medical treatment as of this date. Employee also alleges similar symptoms last year, following the flu shot, but did not put it together until it happened again this year.									Y	11/01/2006	11/02/2006	1		UNK	UNK				Blepharedema~Influenza (Seasonal) (Fluzone)~~0.00~In Patient		1						1	Chest discomfort; Eyelid oedema; Face oedema	FLU3~SANOFI PASTEUR~U2202AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266496	11/10/2006	OH	44.0	44		M	11/10/2006	PATIENT EXPERIENCED CELLULITIS TYPE REACTION AT SITE OF PNEUMONIA VACCINATION AND VISITED HIS PHYSICIAN, PHYSICIAN ASKED FOR REACTION TO BE REPORTED BUT NO TREATMENT WAS GIVEN.				Y					U	11/09/2006	11/10/2006	1		UNK	UNK	METHADONE 40MG TID OXYCODONE 15MG TID CARISOPRODOL 350MG HS	OXYCODONE				1						1	Cellulitis; Injection site reaction	FLU3~SANOFI PASTEUR~421877AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0958F~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0266499	11/10/2006	CO	30.0	30		F	11/10/2006	11:20AM-Pt was given 3 vaccines. 1st)Influenza-L Deltiod. 2nd)MMR-L upper arm,SQ 3rd) Adacel (Tdap)-R Deltoid. Within 3 minutes after Adacel injection, pt c/o extreme itching to R upper arm. On inspection, the area around the Adacel injection site was reddened and swollen, from approx 1 1/2 inches below the site up and over her shoulder.  Pt took a Benadryl, then stated this isn't going to work. The rash was spreading quickly to her neck and face.  I drew up a dose of Epinephrine (0.5cc) and injected it into the pt's L upper arm.  About 90 seconds later, the pt stated It isn't working. I drew up a 2nd dose of Epinephrine, (0.5cc), and gave it to her in her R upper arm. Then, immediately after, a co-worker began to transport pt to the Emergency Dept.  The total time spent from initial injection to leaving for the ED was less than 5 minutes.  The pt cored on the way to the ED, approx 3 minutes after leaving the office.  The pt was taken directly to the ICU, where she was intubated.  1/19/07 Received medical records from hospital which reveal patient admitted 11/10-11/13/06 for anaphylaxis & SOB s/p vax. Required intubation due to unstable airway.  Treated with high dose steroids & Benadryl.  Extubated following day but had bronchoscopy & was re intubated due to labored breathing & edematous soft tissue above the vocal cords.  Successfully extubated on 11/12 & remained stable for 24 hours prior to d/c home.  Patient was to obtain a PCP & get appointment ASAP. FINAL DX: Anaphylaxis, secondary to vax; vocal cord dysfunction; history of depression. Followup 3/30/2010. We are almost certain it was the Tdap (adacel) vaccine that caused the reaction.			Y		Y	3			Y	11/10/2006	11/10/2006	0		UNK	UNK	Tylenol, Tylenol PM,Benadryl, Wellbutrin, Prozac, Trileptal, Abilify, Effexor.	None	Allergies to ASA, PCN, Cipro, Ceclor, Sulfa, Tetracycline, Erythromycin. Hx of Anaphylactic RXN to shellfish, depression. Allergies: Has multiple allergies & has had several episodes of anaphylaxis.  PMH: Intubated 4 times over past year for airway management.			1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA211BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|MMR~MERCK & CO. INC.~0310F~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TDAP~SANOFI PASTEUR~C5229AA~UNK~IM~RA~TDAP (ADACEL)~1	USA	Life Threatening,Hospitalisation	Influenza
0266500	11/10/2006	AZ	1.66	1	.7	M	11/10/2006	~16 days after immunization pt. developed bilateral [[name]] pain and refusal to weight bear, extreme irritability and fussiness.  Waking from sleep at night.  ~25 days after vaccine continued irritability and ED visit with pain with neck flexion as well as hip flexion.  No fevers.  Given Tylenol/Motrin throughout course.  Admitted to hospital, underwent LP with high protein, no other abnormalities.  Had EMG which demonstrated conduction velocities of acquired peripheral nerve disease and diagnosed with Guillan [[name]] Syndrome. 12/21/06 Received medical records from hospital which reveal patient admitted 11/4/06-11/13/06 after having severe cervical & back rigidity & pain with significant irritability for approx 9 days.  Patient had been seen at multiple outpatient facilities prior to admit & dx w/viral syndrome.  Admitted with meningismus & irritability.  Tx w/IVIG.  Responded slowly but was able to again walk at time of d/c.  Was to f/u w/neuro & have PT/OT at home. Final Dx: Guillain [[name]] Syndrome with additional dx of sensory neuropathy, encephalopathy and plexopathy changes.				Y	Y	9			U	10/05/2006	10/14/2006	9	CSF protein 1352 CSF culture- no growth x 72 hours EMG- conduction velocities of acquired peripheral nerve disease LABS: LP revealed protein 1352, glucose 38, WBC 4.  MRI of spine revealed neuritic change c/w possible lumbar plexopathy.  EMG/NCS revealed polyneuropathy c/w GBS.  Cultures all neg.  Cocci serologies neg.	UNK	UNK		No	None			1						1	CSF test abnormal; Guillain-Barre syndrome; Insomnia; Irritability; Nervous system disorder; Pain; Proctalgia	FLU3~SANOFI PASTEUR~u2174ga~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0266501	11/10/2006	CO	41.0	41		F	11/10/2006	On November 2 about 30 minutes after the injection I became dizzy. On November 3 I still felt light headed and nausea with pain around a 5 in right arm all day. The night of November 3 I noticed large welts on right arm.  On November 4 the welts continued into my armpit and into the right side of my chest along with significant pain and swelling in right arm, under arm and chest.  I took Benadryl the afternoon and night of November 4 because I was traveling.  November 5 I took more Benadryl and the swelling began to dissipate.  Through out Noveber 5 the swelling,pain and welts continued to improve with the help of Benadryl.  By November 7 all swelling, pain and welts had resolved.									Y	11/02/2006	11/02/2006	0	None	UNK	UNK	Humira, Methotexate, Folic Acid, Advair, Meloxicam, Prilosec, Bayer aspirin.	none	Ankylosing Spondolyitis, Raynauds disease, vasculitis and small airway disease.			1						1	Dizziness; Nausea; Pain; Swelling; Urticaria	FLU3~SANOFI PASTEUR~U2184AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1049P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266502	11/10/2006	OR	39.0	39		M	11/10/2006	Adverse Reaction Timeline:  09:30 am: I received a flu vaccination (FLUARIX). 10:30 am: I began to experience the onset of a headache. 10:45 am: I began to experience pain and soreness in my right arm. 11:00 am: My headache had become more painful. 11:30 am: I ate lunch and took extra strength Tylenol hoping to alleviate the pain I was experiencing. 12:30 pm: My headache is now throbbing and I am feeling a slight fever/sweat. 12:45 pm: I depart outside to get some fresh air; it was cool and raining outside.  1: 30 pm:  I took another extra strength Tylenol to try to alleviate the pain of my severe headache, and the pain/sore/stiffness in my right arm. 2:00 pm:   I drank a lot of cold water, but my headache is still throbbing and is more painful as I move my head. 3:00 pm:   I began to experience a slight relief from my headache, but my arm is still sore and painful. 4:00 pm:   The pain of my headache is still there, but is no longer throbbing and as intense. My arm is still painful to move. 5:00 pm:   I took another extra strength Tylenol with dinner and now the pain of my headache is starting to lessen. My arm is still painful when moving or touching. 6:00 pm:   I lied down to take a nap and awoke at 7:00 pm still feeling the pain of my headache and arm. 9:00 pm:   The pain of my headache is lessening, but my arm is still painful. 10:00 pm:  I went to bed still feeling slight pain of my headache, and my arm continues to be painful. 11-08-2006 05:00 am:  I get up still feeling a light headache, but the pain in my arm has now lessened. 06:00 am thru 4:30 pm:  I continued to have a slight headache throughout the day, the pain had lessened in my arm and head, but I experienced extreme and frequent urination all day long. I had to urinate constantly throughout the day, which I thought was very unusual. I had to urinate approximately every 20-30 minutes through out the day, and forced myself to drink water to prevent dehydration. 4:30pm thru 10:00pm: The pain in my arm is very slight, but I continued to have a slight headache. 11-09-2006 I had experienced a light headache throughout the day with some light dizziness and a muffled feeling in my left ear.  11-10-2006 I continue to have slight headaches off and on and experience slight dizziness at times throughout the day. I decided to complete the VAERS-1 form, and called the clinic for information to complete the form. They were very uncooperative and would not give out the full name of the person who administered the vaccine, or the name of the Doctor. They also tried to convince me that the PROBLEMS I was experiencing were not related to the flu vaccine. They did not ask how I was doing, or what measures I should take to alleviate my symptoms. I had to ask them many times for the information required to complete the Form VAERS-1(FDA). They were very uncooperative and extremely unprofessional!! As of 11-10-2006 at 5:31pm I still have a slight headache/dizziness, and if the pain continues I will go to urgent care tomorrow to find out why I am still having these PROBLEMS from the FLU VACCINATION.									N	11/07/2006	11/07/2006	0		UNK	UNK	NONE	NONE	NONE			1						1	Dizziness; Headache; Hyperhidrosis; Hypokinesia; Pain; Pollakiuria; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA215AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0266503	11/10/2006	FL	49.0	49		F	11/10/2006	Minutes after getting the shot, I started to feel paresthesias in different parts of my body, the first one being some burning sensation & very slight pain in a buttock which I self-injured about a year ago (when I injected myself with Toradol & Norflex and since then have had pain & some numbness). Every tingling and/or prickling sensation I felt lasted only very few seconds, it was on different parts of my body (specially arms & calfs), and the whole episode lasted only a few minutes.  Could this have been possible, or was this a product of my imagination?  I wasn't looking for any adverse reaction, I just started to feel this, and suddently it came to my mind that this could be an effect from the vaccine. It lasted for only very few minutes, and I just thought you might want to know about this.									Y	10/09/2006	10/09/2006	0		UNK	UNK	Arthrotec 75 mg  Norflex tab  Atenolol Zantac 75 mg (generic) Phenylephrine HCL tab  Tynelol Arthritis	Sinusitis	Allergic to Codeine R/O Seronegative arthritis Cervical and lumbar HNP's Lumbar radiculopathy DJD, worse in hips & feet CTS, TOS HBP			1						1	Pain; Paraesthesia; Thermal burn	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0266512	11/10/2006	CO	82.0	82		M	11/10/2006	Healthy 82 yo male well at physical exam 10/31/06. Received flu vaccine mass immunization 11/04*06, Ill on Mon-Tues 11/6-7, Admitted to hospital 11/07/06. Steven Johnson Syndrome, Renal and respiratory failure and death on 11/9/06.  11/20/06 Received medical records from hospital which reveal patient admitted 11/7/06-11/9/06 for hypoxia then quickly developed a macular, then petechial associated with circumoral desquamation, very concerning for Stevens Johnson syndrome.  Patient had fever (103-104)/chills, myalgias, DOE w/dry cough, 5# weight loss over 1 week & weakness for approx 1 week prior to admit.  Also had tooth abscess approx 5 days prior to admit for which he did not receive antibiotics.  ID & resp consults done.  No death certificate included. PMH: hyperlipidemia & pre diabetes. LABS: CXR revealed bilat infiltrates w/effusion.  WBC 12.2, plts 40.  Rapid influenza test was neg.  Blood, urine & sputum cultures neg. Final DX: respiratory failure; sepsis, pneumonia, hypotension, renal failure, liver failure. 11/27/06 Received death certificate from funeral home which states COD as sepsis & pneumonia with acute renal failure as contributing factor.	Y	11/10/2006							N	11/04/2006	11/07/2006	3	WBC 44.2, Platelets 51,000, ALT 698, AST 1596, Sodium 132, Creatine 3.7.	PVT	PVT			Pre diabetes, Hyperlipidemia.			1						1	Alanine aminotransferase increased; Aspartate aminotransferase increased; Blood creatine phosphokinase increased; Malaise; Platelet count decreased; Renal failure; Respiratory failure; White blood cell count increased; Asthenia; Blood creatinine increased; Dehydration; Fatigue; Infection; Nausea; Ocular hyperaemia; Pain; Pneumonia; Pyrexia; Renal failure acute; Sepsis; Weight decreased	FLU3~SANOFI PASTEUR~U2255AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2255AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0266526	11/10/2006	CA				M	11/09/2006	Redness and swelling in left axilla, injection given right deltoid opposite arm.				Y					Y	10/20/2006	10/23/2006	3	NONE	PVT	UNK		NONE	NONE			1						1	Erythema; Oedema	FLU3~SANOFI PASTEUR~U2240AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266528	11/10/2006	MO	0.51	0	.5	F	11/10/2006	20 minutes after injections pt developed three 1cm area of erythema on both feet and right lower leg, at about 500 pm mom called from home resolved. Dr will examine pt in office.									Y	11/09/2006	11/09/2006	0		PUB	PUB	Albuterol	RAD, Diaper rash	Respiratory Distress Syndrome, RDP, Prematurity			1						1	Erythema	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B071AA~1~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2176BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0889R~1~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08649C~1~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0266529	11/10/2006	WV				F	11/10/2006	Pt telephoned the office on 11/9/06 one day after receiving the vaccine, stating that she was having joint pain in her legs markly both knees. States that it hurt to straighten her legs. Pt stated that her arm was not sore, red, or swollen. Advised her to come in to the office or at least see her physician for check up and she refused. Instructed pt that this is probably not a reaction to flu vaccine.									U	11/08/2006	11/09/2006	1		OTH	UNK						1						1	Arthralgia	FLUX~UNKNOWN MANUFACTURER~AFLUA123AA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0266530	11/10/2006	MA	90.0			F		Lt arm red, warm to touch, swollen from mid upper arm to anticubital area. C/O discomfort when touch. Physician notified.										11/08/2006	11/09/2006	1	Lt Mastectomy	OTH	UNK						1						1	Discomfort; Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U2215AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266531	11/10/2006	IL	51.0	51		F	11/10/2006	10/18 has mosquito bites on each arm after injection site on upper arm, No temp noted scratching eased after 10/23, still has upset stomach.									Y	10/18/2006	10/19/2006	1		PUB	UNK		NONE	NONE			1						1	Pruritus; Stomach discomfort	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69897~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266532	11/10/2006	DE	7.0	7		M	11/08/2006	Site swollen, red, nausea, vomiting, headaches.									Y	10/30/2006	10/31/2006	1		PVT	PVT			Asthma induced by colds.			1						1	Headache; Injection site erythema; Injection site oedema; Nausea; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71640~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0674E~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266533	11/10/2006	IA	57.0	57		F	11/08/2006	High fever 104 and Neutropenia. Pt presented with hyperpyrexia up to 104. Which began 24 hours after influenza vaccine. Noted to have decreased 1,700 5 days later.				Y					Y	10/18/2006	10/19/2006	1	see attached lab results.	OTH	OTH	Synthroid	NONE	NONE			1						1	Hyperpyrexia; Neutropenia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0266534	11/10/2006	MI	83.0	82		M	11/08/2006	Fever, chills, joint pain and weakness started evening of Flu shot.				Y						11/06/2006	11/06/2006	0	CBC, CMP	PVT	UNK	Hytrin, Tenormin, Singular, Prednisone, Spiriva, Advair, Lasix, Procardia.	Sore foot, resolved Left	allergies PCN EES, HTN, arthritis.	Flu like symtoms~Influenza (Seasonal) (no brand name)~~63.00~In Patient		1						1	Arthralgia; Asthenia; Chills; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72002~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0266535	11/10/2006	IL	46.0	45		F	11/10/2006	B/P 160/110 11/09, 140/90 11/10 at private physician and office extremely tired, had diarrhea 11/04 et felt ill, Sunday 11/05 felt fine 11/06 feet and legs throbbing, no temp, still has frontal headache, left arm sore, achy, throbbing x 4 days									Y	11/03/2006	11/04/2006	1		OTH	PVT						1						1	Blood pressure increased; Diarrhoea; Fatigue; Headache; Malaise; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70739~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266536	11/10/2006	MA	55.0	55		M	10/20/2006	Developed headache 10/18/06 worsened 10/19/06. Developed achy joints and low back discomfort felt tired for 1 week.									Y	10/12/2006	10/18/2006	6		PUB	PVT						1						1	Arthralgia; Back pain; Discomfort; Fatigue; Headache	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA21AA~1~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0266537	11/10/2006	TX	12.0	11		M	11/10/2006	Significant shortness of breath and stridor moderate distress and wheezing. Xopenex 0.63 mg nebulizer was administered which improved pts condition stridor resolved completely.				Y					Y	11/08/2006	11/08/2006	0	PFTS, B/P	PVT	PVT						1						1	Dyspnoea; Respiratory distress; Stridor; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500434P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0266538	11/10/2006	WI	21.0	20		F	11/09/2006	Flu vaccine given 11/7/06 approx 3pm, next morning pink rash (with itching) over trunk and extremities.										11/07/2006	11/08/2006	1		OTH	PVT			Has allergy to corn, cinnamon and Blueberries and sulfa drugs.	rash~Hep B (no brand name)~2~18.00~In Patient		1						1	Rash pruritic; Skin discolouration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71647~2~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266539	11/10/2006	NJ	11.0	11		M	11/10/2006	Large, red, swelling at site. Treatment Benadryl, cool packs, observation.									Y	11/04/2006	11/05/2006	1		PVT	PVT						1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U2238AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1042F~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0266540	11/10/2006	NJ	18.0	17		M	11/10/2006	Redness, swelling at site of injection (50mm x 50mm), hardness. Symptoms still resolving. Treating with Motrin for pain, observation.										11/08/2006	11/09/2006	1		PVT	PVT			Codeine allergy, Migraines.			1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U2238AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2159AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~1060F~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0266542	11/10/2006	NH	69.0	69		F	10/26/2006	Erythema left arm, pt reported Tues evening 10/24 pain arm, stiffness and pain left side body cramping left leg Tues with increased difficulty breathing.									Y	10/24/2006	10/25/2006	1	Office visit	PVT	UNK		NONE				1						1	Dyspnoea; Erythema; Muscle spasms; Musculoskeletal stiffness; Pain	FLU3~SANOFI PASTEUR~U2169PA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266544	11/10/2006	FL	84.0	84		F	11/06/2006	Pt admitted to medical center 10/24/2006 for SOB and resp distress. No documented fever. Long standing H/O COPD. Pt expired 11/2/06 no autopsy done.	Y	11/02/2006							N	10/17/2006	10/24/2006	7		PVT	PVT	Oxygen 2 liters, nebulizer four times a day, singular 10mg every morning, spiriva every morning, albuterol inhaler twice a day, advair 100/50 twice a day, Ibuprofen 200 mg as needed, Xanax 25 mg 1/2 tab by mouth  as needed, B12 500mg liquid		COPD			1						1	Dyspnoea; Respiratory distress	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70707~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0266545	11/10/2006	VA	6.0	6		M	11/06/2006	10/25/06 am school nurse called to take child to Doctor. Rash hives on feet morning of 10/26/06 I reported to school nurse. Evening of 10/26/06 rash spread through body. Got appt 9:00am. 10/27/06 rash appeared to turn to blisters in certain areas of body spreading through out. Treated with Bacitracin zinc ointment. Prescription by Dr. Child did not have high fever. He experienced chills and sweating. Loss of appetite. Sores in mouth and nose, underneath tongue discoloration. Fast heart beat, tiredness. Also treated with Children's Benadryl and appears to have recovered today.  12/14/06 Received medical records which included Lot number.  Reveal patient seen on 10/25 with cold s/s of sore throat, nasal congestion & dry cough for approx 1 day.  Afebrile.  Exam revealed purulent nasal discharge & erythematous pharynx.  Received flu shot.  Developed rash which started on feet following day & spread to extremities.  Exam on 10/27 revealed gen macular erythematous rash with several erythematous, papular & occasionally umbilicated lesions on dorsal & ventral aspect of feet, palms, buttocks belly, chin & mouth.  Patient was out of school until 11/6/06. Final Dx: Hand, foot & mouth disease.				Y						10/25/2006	10/26/2006	1	LABS: rapid strep was neg.	UNK	UNK		Cold	Cleaning of ears.			1						1	Anorexia; Chills; Fatigue; Hand-foot-and-mouth disease; Heart rate increased; Hyperhidrosis; Injection site vesicles; Mouth ulceration; Rash; Tongue discolouration; Urticaria	FLU3~SANOFI PASTEUR~U2201BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266504	11/11/2006	VI	3.0	2	.9	M	11/11/2006	Parents brought child to clinic for fever (102.1 on arrival) and listless.  Fever since early this morning (about 10 hours).  had not given any remedy for fever.  Was seen by MD and given tylenol suppository for fever and parents advised of fever control.  no other symptoms voiced.  child received flu vaccine 2 days ago.				Y					Y	11/09/2006	11/11/2006	2	none	UNK	UNK	denies	mother denies	Mother states child has history of freqent episodes of pneumonia (last in July 2006)and bronchitis.  Also speech delay.			1						1	Listless; Pyrexia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266505	11/11/2006	WA	14.0	14		F	11/11/2006	The day following administration of Nasal Flumist, developed mild urticarial rash on nose and cheeks.									U	11/10/2006	11/11/2006	1		UNK	UNK	None	None	? h/o mild allergic rhinitis.			1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500433P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~MERCK & CO. INC.~074TF~UNK~IM~LL~HEP A (VAQTA)~1	USA		Influenza
0266506	11/11/2006	CA	4.0	4		M	11/11/2006	One day after flu shot mother noted 3x2 cm swelling and redness on left thigh where injection had been given.									Y	11/10/2006	11/11/2006	1	None	UNK	UNK	None	None	None			1						1	Injection site erythema; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~5~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0265783	11/12/2006	CA	51.0	51		F	10/23/2006	I had the flu shot on Friday and by Sunday, felt still very tired and started to get congested and coughing. I have continued to be congested (yellow) and coughing and it's more than a week later. When I had the shot the nurse drew blood so site was sore.									N	10/13/2006	10/15/2006	2		OTH	PVT	Toprol XL	NONE	HBP; Seizure disorder			1						1	Cough; Fatigue; Injection site pain; Nasal congestion	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71215~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266507	11/12/2006	NJ	63.0	63		M	11/12/2006	Developed high fever and severe body ache within 18 hours.  Attempted control with 1 gm acetaminophen every four hours.  After thre (3) doses changed to 400 mg ibuprofen every six (6) hours.  Fever subsided in 24 hours. Aches persisted for two (2) sufficient to warrant continued medication.									Y	11/09/2006	11/10/2006	1		UNK	UNK	none	none	hay fever			1						1	Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~7+~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266509	11/12/2006	CA	33.0	33		F	11/12/2006	I had a severe reaction to the flu shot.  In addition to feeling like I have the flu, I have hives on most every part of my body-solid raised and large hives on the inside and outside of my legs, behind, arms and chest.  My nose is runny.  I continue to have major hives and swelling of the legs, feet and hands and it is 5 days later.  I still feel very ill.  My hives burn and itch.    There have been no changes in diet, creams or my environment.  I am not allergic to eggs.				Y					N	11/07/2006	11/07/2006	0		UNK	UNK	atenolol aciphex	one	penicillin, eurithromiacin, amoxicillin, sulfa, fish,   lqts, gerd			1						1	Malaise; Oedema peripheral; Pruritus; Skin burning sensation; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0266510	11/12/2006	NY	38.0	38		F	11/12/2006	Chest congestion with slight wheezing beginning about three hours after injection and lasting for about 48 hours.									Y	11/02/2006	11/02/2006	0		UNK	UNK	Vitamin B-Complex and Calcium supplements	NA	NA			1						1	Nasal congestion; Wheezing	FLU3~SANOFI PASTEUR~U2217AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266511	11/12/2006	CA	8.0	8		F	11/12/2006	Arthus reaction: left deltoid region.									U	11/11/2006	11/11/2006	0		UNK	UNK		none	asthma	arthus~Influenza (Seasonal) (no brand name)~1~4.50~In Patient		1						1	Type III immune complex mediated reaction	FLU3~SANOFI PASTEUR~U2252AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266517	11/13/2006	AZ	13.0	12		F	11/10/2006	Marked redness, swelling and pain at site of PPV 23, Headache, nausea, dizziness, neck pain.										11/07/2006	11/09/2006	2		PVT	PUB		NONE	NONE			1						1	Dizziness; Headache; Injection site erythema; Injection site oedema; Injection site pain; Nausea; Neck pain	FLUN3~MEDIMMUNE VACCINES, INC.~500434P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|PPV~MERCK & CO. INC.~0899F~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~AVENTIS PASTEUR~U1637EA~1~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0266519	11/13/2006	CA	32.0	32		F	11/10/2006	Flu vaccine leaked out the side of the syringe (BD integra) where the needle attaches. Vaccine dripped down her arm and got on her face. 0.3 ml (adjusted dose) was then readministered.									Y	10/27/2006	10/27/2006	0		OTH	PVT						1						1	Medication error	FLU3~SANOFI PASTEUR~U2240AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266520	11/13/2006	ID	30.0	29		F	11/10/2006	Nausea, Dizziness, flushed feeling. Person suffers from panic attacks, low BP 92/58.				Y					Y	11/10/2006	11/10/2006	0	Parasympathetic reaction, possible reaction to panic disorder.	OTH	UNK		Dizziness and nausea	Panic disorder, Anxiety.			1						1	Dizziness; Flushing; Nausea; Panic reaction	FLU3~SANOFI PASTEUR~U2218AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266521	11/13/2006	ID	0.77	0	.8	M	11/10/2006	Wheezing				Y					Y	11/09/2006	11/09/2006	0		PVT	PVT	NONE	NONE	NONE			1						1	Wheezing	FLU3~SANOFI PASTEUR~UT2176JA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266523	11/13/2006	KY	65.0	65		F	11/10/2006	Left arm swelling, redness, warm to touch, soreness (describes as caked-feeling (hardness) under the redness).  Gave shot 11/07/2006 approximately 2 pm-adverse effects started next morning on 11/08/2006 (area effected starts about 3 inches below shot area and goes down arm another 4 to 5 inches) as of 11/10/2006, still experiencing side effects but still have lessened due to BENADRYL. Patient also states diarrhea and nauseated starting next morning.										11/07/2006	11/08/2006	1		OTH	OTH	BENADRYL starting 11/09/2006 in pm and still taking	NONE	NONE			1						1	Diarrhoea; Erythema; Myalgia; Nausea; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70087~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1036P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266524	11/13/2006	FL	1.27	1	.3	F	11/10/2006	Patient was administered DTap/IPV/Flu vaccine within 5 minutes or less after vaccines given, patient developed generalized flushing and urticaria and swelling of lips noted, anaphylaxis.  Patient given Epinephrine SC and Decadron IM with with good response.									Y	11/09/2006	11/09/2006	0	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Anaphylactic reaction; Flushing; Swelling face; Urticaria	DTAP~SANOFI PASTEUR~U1891CA~4~IM~~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U21751A~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0001~3~SC~~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0266525	11/13/2006	IN	3.0	3		M	11/10/2006	Patient received Flumist at age 3 instead of after age 5.										11/05/2006	11/05/2006	0	NONE	PUB	UNK		NONE	NONE			1						1	Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~500439~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0266527	11/13/2006	NY	33.0	33		F	11/09/2006	Approximately 2 hours after vaccine, patient complain of increased hives on back of legs.  Then became painful.  Patient exercised at gym for 1 hour and then noticed swelling of both hands/wrists.  Vomited at 2100.  Took BENADRYL,  by mouth at 2300, as per phone order by private medical doctor.  Next am, patient woke up with increased hives and feet swelling.  Then went to hospital emergency room.				Y					Y	11/03/2006	11/03/2006	0	Hives lasted 3 1/2 days.	OTH	PVT	Zoloft, Wellbutrin, Estrastep FE	Approximately 2 patch of hives	sleep apnea, depression, allergy to wheat			1						1	Pain; Swelling; Urticaria; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71211~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0266560	11/13/2006	ND	74.0	74		M	10/26/2006	Client experienced right sided weakness, mental confusion 12 hrs after receiving flu shot. 11/28/06 Received medical records from hospital which reveal patient admitted 10/25-10/28/06 for final DX: polymyositis exacerbation & TIA.  Had been feeling well until received flu shot 10/23.  He awoke during the night & fell on his way to bathroom.  Continued to have persistent weakness of both upper & lower extremities.  Also had right sided weakness & right facial droop alternating with normal neuro findings. Developed acute pneumonia.  Treated with antibiotics, prednisone & PT.  On 10/28 was transferred to SNF for further PT until final d/c to home on 10/30. FINAL DX: polymyositis flare up; TIA; acute pneumonia; CHF exacerbation; GERD, anxiety; DM type 2./ss					Y	3			Y	10/23/2006	10/24/2006	1	LABS: CK markedly elevated at 2158.  WBC elevated 12,000.  CT of head was WNL.	OTH	PVT		Polymyositis, Diabetes, CHF, pneumonia.	Polymyositis  PMH: polymyositis (dx 2004 by biopsy at Clinic), NIDDM, GERD, anxiety, CHF, colon ca.		ND0615	1						1	Blood creatine phosphokinase increased; Cardiac failure congestive; Confusional state; Facial palsy; Hemiparesis; Leukocytosis; Pneumonia; Polymyositis; Transient ischaemic attack	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71354~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0266562	11/13/2006	NJ	3.0	3		M	11/07/2006	Emesis, trouble breathing, rash, itching, nasal congestion within 20 minutes from influenza vaccine.				Y					Y	11/01/2006	11/01/2006	0		PVT	PVT	NONE	NONE	NONE			1						1	Nasal congestion; Pruritus; Rash; Vomiting	FLU3~SANOFI PASTEUR~022Y3AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266563	11/13/2006	IL	56.0	56		F	11/02/2006	Diaphoresis, tachycardia, shortness of breath, weakness, dizziness									Y	11/02/2006	11/02/2006	0		PUB	UNK	NONE	NONE	NONE			1						1	Dizziness; Dyspnoea; Hyperhidrosis; Hypotonic urinary bladder; Tachycardia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA218BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0266565	11/13/2006	OR	4.0	4		M	11/06/2006	Left deltoid area 9cm diameter, indurated, red, hot, swollen occurred the next day after shot given.  Treated with Orapred.									U	11/02/2006	11/03/2006	1	NONE	PVT	PVT	NONE	NONE	9/1/06 reaction to DTaP vaccine	swelling, hot~DTaP (no brand name)~5~4.00~In Patient		1						1	Erythema; Injection site induration; Injection site warmth; Swelling	FLU3~SANOFI PASTEUR~U2166LA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266566	11/13/2006	PA	70.0			F	11/07/2006	11/01/06 Complain of swelling, redness advised to apply ice and TYLENOL for discomfort.  Call in 2 days to report per doctor.  11/07/06 Area clear no swelling, redness after applying ice.									Y					PVT	OTH		NONE				1						1	Erythema; Swelling	FLU3~SANOFI PASTEUR~U2164AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1036P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266567	11/13/2006	NH	2.0	2	.4	M	11/06/2006	Received Flu vaccine at 0945, one hour after vaccine mom noted patient rolling tongue back and forth inside lower lip.  Became fussy ate a little at 1030.  Refused lunch, fell asleep on way to medical doctor office. Vomited x 2 in office, lethargic but arousable in medical doctor office for 1 hour, then alert and active.  Later at home temperature 100 degrees axillary and fussy. Seemed fine in am 11/7.				Y					Y	11/06/2006			NONE11	PVT	PUB	NONE	NONE	NONE		NH0707	1						1	Irritability; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~UT2175BA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266569	11/13/2006	OH	52.0	52		F	11/08/2006	Headaches, denies resp symptoms multiple hives from right axilla arm to thigh. Scattered on left side.				Y					U	11/06/2006	11/07/2006	1		PUB	UNK			Asthma			1						1	Headache; Urticaria	FLU3~SANOFI PASTEUR~U2247AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266571	11/13/2006	WA	53.0	53		F	11/07/2006	Felt SOB, eyes itchy, swollen had flu like symptoms. Took Benadryl and symptoms. Were lessened. No hosp visit needed.									Y	11/05/2006	11/05/2006	0		PVT	UNK	Simbalta, Thyroid, Estradiol.					1						1	Dyspnoea; Eye disorder; Influenza like illness; Pruritus	FLU3~SANOFI PASTEUR~U2255AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266573	11/13/2006	NC	75.0	75		F	11/06/2006	Left arm began to ache about 1 hour after dose given then right arm began to ache similarly later same day. Pt also had upset stomach no diarrhea or nausea.									Y	10/30/2006	10/30/2006	0	NONE	OTH	PUB	SYNTHROID; lipid lowering; BP medication.	NONE	Hypertension, Hypothyroid, High cholesterol.			1						1	Pain; Stomach discomfort	FLU3~SANOFI PASTEUR~U2215AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266576	11/13/2006	MO	47.0	46		F	11/10/2006	Injection site within 5 minutes turned red and started itching severely. Claritin 10mg was administered PO. Ice pack was administered topically. Within 15 minutes DX relieved.									Y	11/09/2006	11/09/2006	0		PVT	UNK		NONE	Anxiety, Fibromyalgia			1						1	Injection site erythema; Injection site hypersensitivity; Pruritus	FLU3~SANOFI PASTEUR~U2196AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266577	11/13/2006	KS	42.0	42		F	11/08/2006	The flu shot was given on 10/18/06. The next morning, there was severe pain in the shoulder which felt like the muscle was torn or out of the socket. This lasted for 4 days. The pain started to decrease for 2 days On 10/25/06, woke up with excruciation pain, described as sharp, knife pain, with burning, radiating pain from the should to the elbow. Additionally, there was deep inside the bone pain. Went to the doctor on 11/01/06 was told to apply heat and take ibuprofen. On  11/3/06 and 11/4/06 ran a temp of 100.5 with body aches, sore throat and splotchy hives on stomach and chest (which started before the temp). The arm pain continues and seemed to be amplified by the fever. 11/05/06 no temp. 11/07 no sore throat. The intense pain is decreasing. The arm now feels weak and with muscle pain on the inside and outside of the arm. Arm mobility and range is limited due to pain.				Y					N	10/18/2006	10/19/2006	1	NONE	OTH	OTH	NONE	NONE	NONE			1						1	Asthenia; Bone pain; Joint range of motion decreased; Myalgia; Pain; Pharyngolaryngeal pain; Pyrexia; Rash maculo-papular; Shoulder pain; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA210BA~1~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0266581	11/13/2006	VA	19.0	18		F	11/08/2006	Vasovagal RXN. Pt HR decreased to 50 and BP decreased.									Y	10/13/2006	10/13/2006	0	Skin prick tested for allergies.	PVT	PVT	Allegra, Nasolcrom, Acne meds, Bactrim	NONE	Acne, allergies to raw peaches, carrot, potatoes, kiwi, apples, cherries.	Fever~DTP (no brand name)~1~1.17~In Patient		1						1	Blood pressure decreased; Bradycardia; Heart rate irregular	FLU3~SANOFI PASTEUR~U2165CA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0688F~1~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0266582	11/13/2006	OH	14.0	13		M	11/07/2006	Rapid Breathing, Close throat, weakness, asthma symptoms.				Y					Y	11/03/2006	11/03/2006	0	Questionaire, symptoms, heart monitor.	OTH	PVT	NONE		NONE			1						1	Asthenia; Asthma; Respiratory rate increased; Throat tightness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69240~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0266584	11/13/2006	MO				U	11/07/2006	We have had several complaints that severe pain, erythema and swelling for 48-72 hours after injection. Please advise.									Y	11/03/2006	11/04/2006	1		PVT	UNK						1						1	Erythema; Pain; Swelling	FLU3~SANOFI PASTEUR~U2196AA~UNK~ID~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266585	11/13/2006	WY	66.0	66		F	11/03/2006	Received Pneumovac vaccine in AM and began having severe pain in same arm a few hours later. Says pain was a 10 unable to sleep. Today 11/3/06 pain is an 8. No redness, no swelling, no fever. Says pain felt like a knife digging in arm. Encouraged to take usual pain med-Tylenol. Continued pain thru 11/06/06-warm compresses helped relieve pain.									Y	11/02/2006	11/02/2006	0		PUB	PVT	None	None	None			1						1	Insomnia; Pain	FLU3~SANOFI PASTEUR~U2218AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0620F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266586	11/13/2006	WY	65.0	64		M	11/03/2006	Received pneumovax vaccine approx 11:00am. By 19:00 experienced severe pain in Left arm. Did not see any redness or swelling. Denies fever. On scale of 1-10, says pain was a 3. Says pain is easing up and much better today 11/3/06.									Y	10/26/2006	10/26/2006	0		PUB	PVT	None	None	None			1						1	Pain	FLU3~SANOFI PASTEUR~U2218AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1044P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266588	11/13/2006	MI	72.0	72		F	11/09/2006	Received Fluzone on 11/3/06 in AM by 6 PM same day noticed left side of face droopy. Went to ER Saturday 11/4/06 in afternoon. DX with Bells Palsy. Still droopy at this time 11/9/06. DC DX: Bell's Palsy in ER on 11/4/06 Seen in ER for facial assymetry on right. Difficulty closing left eye. CT head: evaluation of posterior fossa was mildly degraded by streak artifact. The fourth ventricle is midline without mass impression. Evaluation of suprtentorial brain revealed evidence of coritcal mild atrophy. No ventriculomegaly. No mass or midline shift. No extraazxial fluid collection. No acute major territorial infarct or intracranial hemorrhage				Y					U	11/03/2006	11/03/2006	0	Took blood at hospital	OTH	PVT	Lopressor, Protonix	None	None			1						1	Facial palsy	FLU3~SANOFI PASTEUR~U2242AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266589	11/13/2006	TN	55.0	55		F	11/07/2006	Swollen/hot area around injection site. Dr. did not think this was true allergic reaction. Dr. recommended ice on arm and come back Friday. Local reaction.				Y					Y	11/06/2006	11/07/2006	1		OTH	PVT		None	None			1						1	Feeling hot; Injection site reaction; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72002~1~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0266590	11/13/2006	OR	1.33	1	.3	F	11/07/2006	Febrile seizure on 10/31/06 with emergency room follow up visit on 11/01/06. Chart notes from office visit attached. Emergency room report attached. Patient apparently has been fussy all day with probable fever although mother has not checked it. As she was being held in mother's arms this afternoon approximately an hour prior to arrival mother noticed that eyes rolled back in head, became rigid and was not breathing well. Her lips became blue. This lasted for 20-30seconds and then she became limp. Paramedics arrived. She was a bit lethargic at that point. Axillary temp is 103.7. Vital signs were otherwise stable. She was transported to this facility. Has not had any cough for URI symptoms, no nausea or vomiting, no diarrhea.				Y					Y	10/23/2006	10/31/2006	8	Neurological exam: She is alert and oriented and moves her extremities appropriately, with normal tone. Pupils are equally round and reactive to light and extraocular movements are intact.	PVT	PVT	Sodium Fluoride	Failure to thrive				1						1	Eye movement disorder; Febrile convulsion; Hypotonia; Irritability; Lethargy; Respiratory disorder	FLU3~SANOFI PASTEUR~U2193AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0279F~4~IM~RL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0974F~1~SC~LL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|PNC~PFIZER\WYETH~B08670C~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0266591	11/13/2006	NJ	41.0	41		F	11/10/2006	Monday of vaccine developed itchiness armpits/rash. Benadryl taken. 11/2/06 rash in AM, took Benadryl 50mg. 5:30pm hives, breathing difficulty went to urgent care center. Nebulizer/IM epinephrine, prednisone and Benadryl. 11:30pm hives received to St Barbabas Nebulizer, IM Epi, prednisone and Benadryl. 2AM symptoms recurred-Epi, Prednisone, Benadryl, nebulizer. Adarax and prednisone given on discharge.				Y					Y	11/01/2006	11/01/2006	0		OTH	PVT	Advair	None	Severe asthma			1						1	Dyspnoea; Pruritus; Rash; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70618~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0266592	11/13/2006	PA	11.0	11		F	11/06/2006	Fine red, papular, pruritic rash on 1st and 2nd digits both hands and dorsum both feet.									U	10/31/2006	11/01/2006	1	None	PVT	PVT	None	None	None			1						1	Erythema; Rash; Rash papular; Rash pruritic	FLU3~SANOFI PASTEUR~U2199AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0955F~1~IM~RA~HPV (GARDASIL)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B011CA~6~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0266596	11/13/2006	WI	57.0			M	11/06/2006	103-103.8 fever, uncontrollable shaking, vomiting, Diarrhea, missed 2 days work 10/25/06 and 10/26/2006.									Y					OTH	OTH		NONE				1						1	Diarrhoea; Pyrexia; Tremor; Vomiting	FLUX~UNKNOWN MANUFACTURER~70279~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0266597	11/13/2006	MO	34.0	33		F	11/03/2006	Received flu shot left deltoid. Noted this morning pin size red dots from shot site to elbow. Non raised, no itching. Stated approx 50 spots. Instructed to notify MD.									U	11/02/2006	11/03/2006	1		OTH	PVT			NONE			1						1	Injection site rash	FLU3~SANOFI PASTEUR~U2274AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266598	11/13/2006	IA	29.0	28		F	11/07/2006	Severe muscle aches, vomiting, headaches, runny nose, general malaise which started abruptly the day after receiving her flu vaccine.									Y	10/28/2006	10/29/2006	1	CBC revealed leukopenia, consistent with Flu like illnesses.	PVT	UNK	Norolog insulin	NONE	Type I Diabetes Mellitus.			1						1	Headache; Influenza like illness; Leukopenia; Malaise; Myalgia; Rhinorrhoea; Vomiting	FLU3~AVENTIS PASTEUR~U2242AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266599	11/13/2006	IN	43.0	42		F	11/03/2006	2.5 x 3.5 erythematous slightly raised area.									Y	11/01/2006	11/02/2006	1	NONE	PVT	OTH	Zithromax, Tussinex.	Upper Respirator illness	Bronchitis, History breast cancer.			1						1	Erythema; Rash maculo-papular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA223AA~2~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0266600	11/13/2006	IA	60.0	60		M		Pt reported pain at injection site 1 day following administration of the flu shot. The pain has persisted for 2 weeks pain with movement and raising his left arm.									U	10/20/2006	10/21/2006	1		PUB	PUB	Propanolol, Primadone.	NONE	Tremors.			1						1	Hypokinesia; Injection site pain	FLU3~SANOFI PASTEUR~U2180AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266601	11/13/2006	MI		72		U		Injection 11am, 6pm unwell. 9:30 pm brassy cough, temp 101.6, nausea, next morning to void, nausea, felt strange, faint, lay on floor, no temp crawled to bed. BP 97/58, pulse 68. Better now.									Y	10/21/2006	10/21/2006	0		PUB	OTH			Molds, Dust, asthma, GERD			1						1	Cough; Malaise; Nausea; Pyrexia; Syncope	FLU3~SANOFI PASTEUR~U1278AA~1~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266602	11/13/2006	MH	53.0	53		F	11/07/2006	Redness, itching, heat began in left arm with injection progressed across upper chest and into upper right arm, histamine reaction resolved with 150 mg Ranitadine and Prilosec.									Y	11/06/2006	11/06/2006	0		OTH	OTH	Plaquenil, Lisinopril.	NONE	Morphine, Indocin, systemic lupus.			1						1	Erythema; Feeling hot; Injection site erythema; Injection site hypersensitivity; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U2201AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266603	11/13/2006	CA	44.0	43		F	11/02/2006	Pt was observed after flu vaccine as she developed soreness in mouth after previous 2 flu vaccines. No swelling in tongue throat no chest tightness. She developed angioedema, difficulty breathing and swallowing. TX with Epi, Benadryl, Kenalog. Improved but catw returned tx at clinic.									Y	10/26/2006				UNK	UNK			HX asthma, Idiopathic angio edema.	sores in mouth~Influenza (Seasonal) (no brand name)~~41.00~In Patient		1						1	Angioneurotic oedema; Dysphagia; Dyspnoea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0266605	11/13/2006	MI	37.0	37		F	11/03/2006	Red water eyes, dry cough, chills w/o fever body aches 6 hours after receiving flu shot 11/01/06. All symptoms resolved approx 9 hours later.									Y	11/01/2006	11/01/2006	0		PVT	PVT		NONE				1						1	Chills; Cough; Lacrimation increased; Ocular hyperaemia	FLU3~SANOFI PASTEUR~U2189AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266606	11/13/2006	VA	88.0	87		M	11/07/2006	Vaccine morning of 10/31/06 was achy and stiff neck next day, stiff neck continued and was severe 11-04 and 11/05. Stated better yesterday evening.										10/31/2006	11/01/2006	1		PUB	UNK	Cortisone injection early 10-06	NONE	NONE			1						1	Musculoskeletal stiffness; Pain	FLU3~SANOFI PASTEUR~U2256AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266607	11/13/2006	AZ	26.0	25		F	11/03/2006	30 minutes after injection, pt noticed redness and swelling at injection site. this progressed to swollen eyes, pruritus on face and upper trunk and periorbital edema. Lips were tingling and mild nausea. treated with Diphenhyromide and Prednisone x 2 days. Pt returned several hours later with palpitations and tachycardia and anxiety. pt calmed down over 2 hours and discharged home.				Y					Y	10/26/2006	10/26/2006	0	NONE	PUB	PUB		NONE	HX allergy to morphine, codeine, Darvocet, Wolff Parkinson while out of the country S/P ablation.			1						1	Anxiety; Eye oedema; Injection site erythema; Injection site oedema; Nausea; Palpitations; Paraesthesia; Periorbital oedema; Pruritus; Tachycardia	FLU3~SANOFI PASTEUR~U2219AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266609	11/13/2006	TX	31.0	31		F	11/07/2006	Redness and swelling at site, itching to area.									Y	11/06/2006	11/06/2006	0		UNK	UNK						1						1	Injection site erythema; Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~U2245AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266610	11/13/2006	NM	6.0	5		M	11/02/2006	Pt received Flu vaccine in clinic 15 minutes after experiencing flushing of right side of chest and face that progressed to both sides. Heart rate increased to 171, temp increased 37.6.				Y					Y	11/01/2006	11/01/2006	0	Monitored HR , TO, BP, O2 Sat, lung and chest, heart exam done.	OTH	OTH	Phenobarb, Topomax, Benadryl, Nasonex, Prednisolone, Dilantin.					1						1	Flushing; Heart rate increased; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71826~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0266611	11/13/2006	NH	51.0	51		F	11/06/2006	8am shot 11am coughing and sneezing, 12pm fever, chills, aches, bloodshot and watery eyes, all over sick feeling (like I had the flu from shot, trouble breathing, wheezing. Took 1 Benadryl which helped a little, but still have reaction day after shot. Was given flu shot for those allergic to latex, supposedly.									N	11/05/2006	11/05/2006	0		PUB	OTH	Synthroid, Estrace, Toprol, Lisinopril, Prevacid, Allegra.		Latex, Sulphur, iodine, animal dander, aspirin sensitivity.	very ill~Influenza (Seasonal) (no brand name)~~50.00~In Patient		1						1	Chills; Cough; Dyspnoea; Influenza like illness; Lacrimation increased; Malaise; Ocular hyperaemia; Pain; Pyrexia; Sneezing; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0266612	11/13/2006	NV	62.0	61		F	10/23/2006	10/21/06 local redness, swelling, sore, 10/22/06 redness extend to elbow, visit urgent care DX cellulitis, TX IV antibiotics plus oral Keflex.				Y					Y	10/20/2006	10/21/2006	1		OTH	PVT						1						1	Cellulitis; Injection site erythema; Injection site oedema; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA204BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0619F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0266615	11/13/2006	OH	54.0	53		F	11/06/2006	About 1-1.5 hrs after getting flu shot developed itching, and tightness in chest. Site of injection red and swollen. Treated with Epi 0.3ml SQ which relieved symptoms and then Zyrtec 10mg prescribed.				Y					Y	10/17/2006	10/17/2006	0	None	PVT	OTH	Lasix, Lisinopril, Metag, Lovastatin, Plavix, Restoriz, aspirin	None	Diabetes, heart disease			1						1	Chest discomfort; Injection site erythema; Injection site swelling; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70279~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0266616	11/13/2006					U		A report was received from a health care professional on 11/2/06 concerning an unidentified vaccinee, with a past medical history of pancreatitis, who experienced an episode of pancreatitis where the possible etiology was Fluvirin administration. No pt identifiers, details of the vaccines concomitant medications, or dated of Fluvirin administration or the event were provided. Further information is requested.														UNK	UNK	Concomitant drugs not reported.		History of pancreatitis		CVOX200600585	1						1	Condition aggravated; Pancreatitis	FLU3~EVANS VACCINES~~UNK~~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266627	11/13/2006	WI	1.14	1	.1	M	11/08/2006	11/2/06 at midnight developed a fever to 104.7F. Did not respond to Tylenol. Resolved within 24 hours.									Y	10/19/2006	11/02/2006	14		PUB	PUB	None	None	Allergic to Cefprozil			1						1	Pyrexia	FLU3~SANOFI PASTEUR~U2174HA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~9104510~1~SC~LA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|VARCEL~MERCK & CO. INC.~0638R~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0266637	11/13/2006	NC	0.5	0	.5	F	11/13/2006	Presented to office next day with temperature of 102.9, rectal.  Had fever of 104, rectal during the night.  Cheeks flushed, fussy.  Diagnose with vaccine reaction.									Y	11/09/2006	11/10/2006	1	NONE	PVT	PVT		NONE	NONE			1						1	Flushing; Irritability; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC1BO79AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2191AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08683E~3~IM~RL~PNEUMO (PREVNAR)~1|TTOX~MEDEVA PHARMA, LTD.~1160R~1~IM~LL~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0266640	11/13/2006	NY	15.0	15		M	11/13/2006	Patient  developed mild problems. Low Vitamin A, Carotene. Given flu shot. Renial disturbance aggravated. Doctor does not feel any relationship to shot. Father feels there is. Seen at down state medical centers.									U	10/20/2006	10/21/2006	1		PVT	PVT		None but autism	History-above autism			1						1	Condition aggravated; Hypovitaminosis	FLU3~SANOFI PASTEUR~U2238AA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266641	11/13/2006	NY	6.0	6		F	11/09/2006	Hives, relieved with use of BENADRYL. MR received documenting TC from pt's mom to office RN re: hives over body following Flumist.  Treated with po Benadryl. No other tx.									Y	11/07/2006	11/08/2006	1	none	PUB	PUB			PMH: Pt. had been on Amoxicillin for strep (-)  infection.			1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500438~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0266645	11/13/2006	VA	25.0	25		F	11/13/2006	The patient was vaccinated 10/30/6.  The following day she presented to employee health witha  3 x 3 reddened hardened area at the site of injection.									Y	10/30/2006	10/31/2006	1	None	UNK	UNK	Cymbalta, Yasmin	None	Topical steroid allergy; diagnosed w/anxiety disorder			1						1	Injection site erythema; Injection site induration	FLU3~EVANS VACCINES~71826~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266646	11/13/2006	VA	26.0	26		F	11/13/2006	Immediately following vaccination 10/30/6, pt developed lump on R arm where tdap was given.  The following AM pt woke up with itching dots under that same arm & throughout the day developed itching under her shirt which she attributed to the tags inside her clothing.  When her husband was cutting the tags from her clothing that afternoon, he observed that there were welts at sight of tag & on legs and belly.  Visited family MD @ 2-3pm that day as breakout was increasing and now encompassed entire body.  She was given a shot of prednisone.  About 8pm that evening, her mother observed that her neck and eyes were swelling and the pt was complaining of her throat tingling--her mother observed her throat was full of welts.  In the interim, the pt took one Benadryl po.  The patient also did an Aveeno bath & used Aveeno lotion.   By the following AM the welts had subsided.  The patient was afraid to go to bed that evening, because she feared she would quit breathing with the tingling feeling she was having in her throat.  Family MD attributed rxn to thimerisol in flu and dtap vaccine pt rcv'd 10/30/6.				Y					Y	10/30/2006	10/30/2006	0		UNK	UNK	None	None	Migraines			1						1	Eye swelling; Injection site mass; Pharyngolaryngeal pain; Pruritus; Throat tightness; Urticaria	FLU3~EVANS VACCINES~71826~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C2492BA~2~IM~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0266647	11/13/2006	DE	33.0	34		F	11/13/2006	24 hours after Influenza Vaccine administered, patient complained of headache, backache, cough and sore arm where injected. Stated no redness present on arm.									U	11/08/2006	11/09/2006	1		UNK	UNK		none				1						1	Back pain; Cough; Headache; Injection site pain	FLU3~SANOFI PASTEUR~U2275AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266649	11/13/2006	NV	45.0	45		F	11/13/2006	Approx. 3 hours later I developed painful, red, itchy eyes, cough, flushed face, need to repeatedly clear my throat.  I went to urgent care, where I was give a Solumedrol injection, and was instructed to take otc Benadryl when I got home.  They diagnosed an allergic reaction and conjunctivitis.				Y					Y	11/09/2006	11/09/2006	0		UNK	UNK	Zoloft	cold sore	none			1						1	Conjunctivitis; Eye irritation; Eye pain; Flushing; Hypersensitivity; Ocular hyperaemia	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0266650	11/13/2006	WI	1.05	1	.1	F	11/13/2006	proquad admininstered im should of been given sq.									Y	11/13/2006	11/13/2006	0	none	UNK	UNK	none	none	none			1						1	Medication error	FLU3~SANOFI PASTEUR~u2253aa~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0507f~3~IM~RL~HIB + HEP B (COMVAX)~1|MMRV~MERCK & CO. INC.~0826f~UNK~IM~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~b08646c~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0266651	11/13/2006	CA	37.0	37		F	11/13/2006	ON 4 NOV 2006 PATIENT NOTICED REDNESS, SWELLING, HARDNESS AND HOT TO THE TOUCH AT INOCULATION SITE.									Y	11/04/2006	11/04/2006	0		MIL	MIL	LIPITOR		MULTIPLE ALLERGIES			1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~A223AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0266652	11/13/2006	GA	48.0	47		M	11/13/2006	1030am: On 11/07/2006 administered FluMist intranasally 0.25mg both nostrils. 1145am: Patient c/o tingling of face, skin tightening and red blotches.  Noted erythema and swelling unilateral left side of face with hives to neck and upper chest.  Patient denied any shortness of breath or difficulty breathing. 1440pm: B/P 147/91, HR 63, RR 18. Administered Benadryl 50mg IM and Solumedrol 125mg IM. 1513pm: Symptoms subsided.  Patient recovered.  Skin complexion normal, no evidence of redness, swelling or hives.  Discharged home with PO Benadryl. 11/13/2006 0830am:  Patient returns to clinic with symptoms worsened.  Vital signs stable. Afebrile. Patient mentioned his eye had swollen shut over the weekend and he felt bad.  Denies any decrease in vision, blurred vision, headache or dizziness. Noted erythema, urticaria, increased swelling especially left outer ear, unilateral left side facial edema with cracking of skin of left upper eye lid and left lymph node enlargement. Additional skin lesion noted to right shoulder annular, redness, cracking of skin and honey crusted.  Patient states it itches like the dickens. Approximatley 1030am:  Patient evaluated and treated with Medrol dose pack and Azithromycin Z-pack.  MR received revealing 2 outpatient visits for c/o sudden onset of red blotches, skin tightening and facial itching initially beginning several hours after Flumist administration. Second visit 6 days later for continued facial redness, itching, and swelling, as well as rash on the right shoulder. Iniitially treated with Benadryl IM and Solumedrol with po Benadryl to continue at home. Medrol dose pak and azithromycin (Z-pak)  given at 2nd visit. DX: 11/07/2006 Allergy to drug serum/vaccines. BP isolated elevated. DX: 11/13/2006 Allergic reaction.  Impetigo									Y	11/07/2006	11/07/2006	0	None.	UNK	UNK	HCTZ 25mg Atenolol 50 mg Clotrimazole 1% Motrin 800mg Meds:  Ibuprofen, HCTZ, Atenolol, Clotrimazole topical.	None stated.	Eczemoid Dermatitis Tinea Corporis Pinguelua Seborrheic Keratosis PMH: 47 yr old with hx. of eczematoid dermatitis, seborrheic keratosis, hyperkeratosis of right 4th toe, H. pylori infection, pinguecula, cataracts, presbyopia, astigmatism, myopia, and isolated elevated BPs.			1						1	Erythema; Eye swelling; Face oedema; Lymphadenopathy; Paraesthesia; Rash macular; Swelling; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500429P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0266654	11/13/2006	GA	38.0	38		F	11/13/2006	day 2: bad headache. day 3: bad headache +sore throat.  day 4: same + chills.  day 5: headache, sore throat, red raised rough rash, cough.  day 6: slept 18 hours. day 7: slept 18 hours. upset stomach and itching began 1-2 days later, and generalized peeling 1-2 days after that.  Headache is now milder.									Y	10/31/2006	11/01/2006	1	-	UNK	PUB	Maxide 25 mg qd Diovan 80 mg qd BCP	none				1						1	Chills; Cough; Headache; Pharyngolaryngeal pain; Pruritus; Rash erythematous; Skin exfoliation; Somnolence; Stomach discomfort	FLU3~SANOFI PASTEUR~U2253AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266656	11/13/2006	WI	65.0	65		M	11/13/2006	Telephone call received from patient on 11/10/2006 at 10:30AM, reporting the following reaction to the Influenza Fluzone vaccine: numbness in joaw and erythema in neck, face, and jaw. Denies any other anaphylactic reactions.									U	11/09/2006	11/10/2006	1	LABORATORY DATA FROM 9/21/2006 HgbA1C:9.9 CPK: 334 Fasting cholesterol: 323 HDL:50 Triglycerides: 266 Calcium: 9.5 Urinalysis: Negative except for glucose 250, protein 100 mg/dL Sodium: 140 Potassium 4.4 Chloride: 98 Carbon Dioxide: 33 Anion Gap: 9 Glucose: 250 BUN: 78 Creatinine: 2.4 GFR: 29	UNK	UNK	Aranesp 230 mcg SC every 2 weeks Metalozone 5 mg po QD Furosemide 40 mg po BID Altace 10mg po QD Aspirin 81 mg po QD Coreg 3.125 1/2 tab in the AM and 12 tab in the PM Diovan 160 mg po QD Norvasc  1mg po BID Ferrous Sulfate 325 mg po BID Om	None except for chronic diseases under question #19.	Diabetes Mellitus Type 2-Insulin Requiring Chronic Kidney Disease Stage 4 Proteinuria/Nephrotoxicity Hypertension Hyperlipidemia History of prostate CA Prostate surgery 2004 Legally blind Cataract replacements S/p appendectomy S/p tonsillectomy s/p prostatectomy Urinary incontinence S/p removal of abdominal tumor Anemia of chronic kidney disease Iron Deficiency Anemia	Reaction per pt.'s primary care provider. Pt. unable to describe specific reaction symptoms.~Hep B (Recombivax HB)~1~0.00~In Pat		1						1	Erythema; Hypoaesthesia	FLU3~SANOFI PASTEUR~42241~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266659	11/13/2006	OR	25.0	25		F	11/13/2006	3 days after the flu shot vaccine my blood pressure was much higher than it usually is(bp taken at rest 130/70 on this instance).   I could feel my heart beating even while sitting down and resting. Symptoms lasted for aprox. 24 hrs.  E-mailed my primary NP for advice regarding high bp (did not mention flu vaccine); no action taken.									Y	11/07/2006	11/10/2006	3	bp 130/70 (normal for patient is 100/60)	UNK	UNK	None	None	allergic to Zoloft (Sertraline);had one seizure.			1						1	Blood pressure increased; Palpitations	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0266662	11/13/2006	NC	6.0	6		M	11/13/2006	Client received flu vaccine 11/8/06. Mother noted RT. deltoid become redden and swelling Thursday pm. Friday morning redness had increased with swelling. Child seen by pvt md and dx with cellulitis at injection site and placed on keflex. Monday  11/13/06 mother states his arm is improving. Client is being followed up by pvt md.				Y					Y	11/08/2006	11/09/2006	1	NONE	UNK	UNK	none	none	none			1						1	Cellulitis; Injection site erythema; Injection site reaction; Injection site swelling	FLU3~SANOFI PASTEUR~U2286AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266663	11/13/2006	MD	59.0	59		F	11/13/2006	I developed a fever to 101.5, pain at injection site, area of erythema measuring 6 inches x 2 inches.  The symptoms persisted for 3 days.									Y	09/27/2006	09/27/2006	0		UNK	UNK		Extensive dental work associated with pain.	ragweed, milk, trees, grasses, animal dander asthma, Gerd, Sleep Apnea,			1						1	Injection site erythema; Injection site pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~7+~SC~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~2~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266664	11/13/2006	WI	1.6	1	.6	F	11/13/2006	11-12-06 11:00 AM - MOM NOTICED T.102.7. LIGHT PINK PINPOINT SPOTS ON ABDOMEN. BY THE AFTERNOON, THE SPOTS HAD SPREAD TO HER BACK. T.>102 DEGREES WITH MOTRIN. 11-13-06 RASH IS NOW ALL OVER HER BODY EXCEPT HER ARMS AND UPPER FACE.T.102.6. THE RASH NEVER DID ITCH NOR IS IT RAISED.									Y	11/10/2006	11/12/2006	2		UNK	UNK		SLIGHT COUGH				1						1	Pyrexia; Rash	FLU3~SANOFI PASTEUR~U2166BA~3~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266665	11/13/2006	GA	24.0	24		F	11/13/2006	Pt developed fever and redness at injection site the day following the vaccination.  Went to ER and was admitted.  Cultures were negative.  Pt had an MRI of affected arm; PICC line placed for administration of abx. 12/29/06 Received medical records from hospital which reveal patient admitted to hospital 10/28/06-11/1/06 with fever, chills & left arm cellulits & hereditary xerocytosis s/p splenectomy remotely at age 3 years.  Patient received both flu & pneumovax in left arm.  ID consult notes that site of flu vax was unremarkable but site of pneumovax was red, tender, angry, inflammed & very painful.  Temp max 102.7 Treated with IV antibiotics, pain meds & continued on oral antibiotics at d/c.  Consult by ID & ortho. FINAL DX: Severe left arm cellulitis; anemia; asplenia secondary to remote splenectomy for hereditary xerocytosis; PCN allergy; & severe leukemoid reaction.				Y	Y	5			Y	10/27/2006	10/28/2006	1	Blood and urine cultures; CBC; CMP per admitting MD.  CXR after PICC placement; MRI of left arm. LABS: WBC max 47,600, segs 87%.  WBC at d/c was 12.1, hgb 11, plts 455. Blood, urine cultures all neg.  CXR was WNL, MRI of left arm revealed evidence of soft tissue infection.	UNK	UNK		None	History of splenectomy.  Allergic to PCN.			1						1	Injection site erythema; Pyrexia; Cellulitis; Dyspnoea; Injection site erythema; Injection site oedema; Injection site pain; Injection site reaction; Pyrexia; White blood cell count increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70736~1~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1047P~2~SC~LA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~1047P~UNK~SC~LA~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0266666	11/13/2006	CA	58.0	58		F	11/13/2006	c/o feeling tingly and itchy one hour after the shot- arms, face, all over. No SOB. On further questioning, pt has reacted to eggs once with similar symptoms.									Y	10/25/2006	10/25/2006	0	none	UNK	UNK	sudafed OTC, ibuprofen	none	asthma, anxiety			1						1	Paraesthesia; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70736~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266673	11/13/2006	IA	32.0	32		F	11/13/2006	Hives, progress to welts, progress lower extremities inflammation, progress facial swelling, including eyes, lips tongue, to eventually include torso, face and limbs.  11/28/06 Received medical records from hospital which reveal patient admitted 10/29-11/03/06.  Rash had developed day after flu shot & progressed to severe itching & SOB.  Seen in ER, treated w/steroids & d/c to home on oral steroids.  Continued to worsen & returned to hospital within 24 hours & ws admitted.  Treated with IV steroids, Benadryl & epi & rash & swelling completely resolved.  She was d/c to home to be followed by allergist. FINAL DX: Severe allergic reaction to flu shot; anxiety; & hyperglycemia.				Y	Y	7	Y		Y	10/24/2006	10/25/2006	1	LABS: WBC 15.5	UNK	UNK						1						1	Anxiety; Hyperglycaemia; Hypersensitivity; Inflammation; Leukocytosis; Swelling; Swelling face; Urticaria; Vaccination complication; Inflammation; Oedema; Urticaria	FLU3~SANOFI PASTEUR~U2165DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2165DA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0266676	11/13/2006	CA	0.78	0	.8	M	11/13/2006	One day after Flu hot patient developed temperature 100.0, vomiting and diarrhea. All symptoms now resolved except diarrhea.				Y					Y	11/09/2006	11/10/2006	1	NONE	PVT	UNK	TYLENOL, BENADRYL	NONE	NONE			1						1	Diarrhoea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~UT2175CA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266677	11/13/2006	CA	23.0	23		F	11/13/2006	Was given Fluarix vaccine IM 10/19/06 at workplace by RN on site. Has reported today pain in arm since and peels as if worsening. Didn't note any swelling/hot/redness or hardening of skin muscle. Hurts when using arm to dress, move, etc.										10/19/2006	10/19/2006	0	NONE	OTH	OTH	NONE	NONE	No egg or latex allergy			1						1	Abdominal pain; Skin exfoliation	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA202BA~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0266678	11/13/2006	IA	77.0	77		F	11/13/2006	Pain in right arm, swelling gradually radiated to fingers. Back at doctor's by 3:30 pm; was given antihistamines condition did not improve overnight back to the doctor's by morning: was given Ibuprofen for pain and fever. Couldn't raise arm for a while. Feeling better by first week of November, today is back to normal.				Y					Y	10/26/2006	10/26/2006	0		PVT	PVT	Lipitor, Aspirin, Atenolol, Anomasin, Zestral, Multivitamin and Vitamin D, E, C	NONE	High cholesterol and high blood pressure, breast cancer in remission since 2005			1						1	Joint range of motion decreased; Pain; Pyrexia; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70738~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0320F~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0266444	11/14/2006	IN	49.0	49		F	11/14/2006	This case was reported by a healthcare professional and described the occurrence of tremor in a 49 year old female subject who was vaccinated with influenza virus vaccine (FluLaval) for prophylaxis. The subject had received influenza virus in previous years with in subsequent adverse events. On 11/9/06 at 8:21am, the subject received a dose of FluLaval. On 11/9/06 at 8:50am, 29 minutes after vaccination with FluLaval, the subject experienced tremor, dizziness, and sweating. The subject returned to the health care professional who had administered FluLaval. the subjects blood pressure was elevated at 170/110mm Hg and her blood sugar was decreased at 60. The subject received juice, crackers and diphenhydramine hydrochloride (Benadryl). The subject then went to the ER and was released the same day. The healthcare professional considered the events were clinically significant (or requiring intervention) (OMIC). The outcome of the events was not reported.				Y					U	11/09/2006	11/09/2006	0	Blood Glucose 11/9/06 60, Blood pressure 170/110mm Hg.	OTH	OTH					A0627333A	1						2	Dizziness; Hyperhidrosis; Blood glucose decreased; Blood pressure increased; Dizziness; Hyperhidrosis; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601311~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601311~UNK~~LA~INFLUENZA (SEASONAL) (FLULAVAL)~2	USA	Emergency room visit	Influenza
0266689	11/14/2006	NY	21.0	21		M	11/09/2006	7 days after vaccine, developed rash over neck. Progressed to inner arms, lower back, buttocks, inner thighs and back of knees. Hot and cold feelings, headaches. We are checking labs and close observation.				Y					N	10/26/2006	11/02/2006	7	CBC; LFT; COAGS; Renal function; ESR; CRP	PVT	PVT	NONE	NONE	Bilateral hearing loss			1						1	Feeling cold; Headache; Hot flush; Rash	FLU3~SANOFI PASTEUR~U2238AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB109CA~1~IM~RA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~Z0421~6~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|TYP~SANOFI PASTEUR~Z0122~1~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|YF~SANOFI PASTEUR~UE896AA~1~SC~LA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0266693	11/14/2006	IL	2.0	2	.4	M	11/09/2006	Febrile seizure possible flu vaccine related. 12/13/06-records reviewed. ER visit 11/7/06- DX:Febrile illness and febrile seizure Pneumonia Bilateral otitis. Temp at home after seizure 100. Temp in ER 103 (R) Transferred to Hospital ovenight stay Follow up visit with PCP on 11/9/06-mild congestion. lungs CTA				Y					Y	11/07/2006	11/07/2006	0	CT of Brain without contrast CXR: minimal perihilar infiltration on the left. CT Brain: examination is markedly suboptimal due to patient motion. No gross evidence of intracranial hemorrhage. Blood culture: negative CBC neutrophils 9.2, lymphocytes 0.4 fbs 140 CO2 19	PVT	PVT	N/A	N/A	N/A			1						1	Febrile convulsion; Otitis media; Pneumonia	FLU3~SANOFI PASTEUR~U2200LA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266694	11/14/2006	OH	6.0	6		M		Redness, swelling and itching 4x6 area left upper arm 24 hours after shot, fever 99.6. I saw him 48 hours after the shot and thought this was likely a reaction but the red area was more painful and larger and not helped by Benadryl, so I wanted to cover the possibility of cellulitis (Rx Keflex). T 97.6; improvement by 11/07/06.				Y						11/04/2006	11/05/2006	1		PVT	PVT		NONE	Kawasaki's Disease 2004 - no coronary artery involvement; Egg allergy.			1						1	Injection site erythema; Injection site hypersensitivity; Injection site swelling; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~U2248AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266695	11/14/2006	IA	68.0	68		F	11/08/2006	Received flu vaccine 10/25/06. Noted increased shortness of breath, cough for over a week prior to receiving vaccine, but more acute 10/27/2006. Pneumonia, on vent, small pneumo, GI bleed. H&P HX of weakness, COPD. MD indicates that a flu vaccince administered 3 days prior to admission and then developed generalized symptoms of SOB, cough and malaise one day prior to admission is likely coincidental.  On ventilator, trached. DC Summary received for DOS 10/28-12/5/06- MRSA positive sputum DC DX: respiratory failure bilateral pneumonitis known left pneumothorax massive GI bleeding anemia secondary to blood loss malnutrition.					Y	8			Y	10/25/2006	10/27/2006	2	CXR: Diffuse wel defined infiltrate in left upper lobe, left lingula and left lower lobe consistent with pneumonia. Cardiomegaly.  Labs: Glucose 248, WBC 32.6.	PUB	PVT		Shortness of breath, cough, malaise	COPD, pneumonia			1						1	Anaemia; Blood glucose increased; Cardiomegaly; Cough; Dyspnoea; Gastrointestinal haemorrhage; Pneumonia; Pneumonitis; Respiratory failure; White blood cell disorder	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71643~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0266696	11/14/2006	IA	18.0	18		F	11/08/2006	Administered FluMist vaccine, Monday 10/30/06. Developed abdominal pain, body aches, nausea about 24 hours later. Had emesis/vomiting 11/1, 11/2.				Y					U	10/30/2006	10/31/2006	1		UNK	UNK						1						1	Abdominal pain; Nausea; Pain; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0266697	11/14/2006	WI	11.0	11		M	11/09/2006	Pt became pale, sweaty and diaphoretic within 2-3 minutes after influenza vaccine was given in left vastus lateralis (IM). Pt was Rx with epinephrine 0.1cc SC injection; Benadryl 25mg IM injection. Patient is presently evaluated by pediatric cardiologist for dilated cardiomyopathy.									Y	11/08/2006	11/08/2006	0		PVT	UNK		NONE	Pre-existing Cerebral Palsy; Cardiomyopathy; Bipolar depression and seizures.			1						1	Hyperhidrosis; Pallor	FLU3~SANOFI PASTEUR~U2165BB~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266698	11/14/2006	IL		50		F	11/07/2006	11/3/06 Soreness right arm, chills, shakes, knot (right) arm started out golf-ball sized - baseball sized to softball size; felt hard. Unable to move arm. Saturday/Sunday, called mom, knot in arm smaller. Still feel hard. Able to move arm. Monday, no treatment.									Y	11/01/2006	11/03/2006	2	NONE	PVT	PVT	Clonazepam; Fosamax; Nexium	NONE				1						1	Chills; Injection site induration; Pain; Skin nodule; Tremor	FLU3~SANOFI PASTEUR~U2243AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0352~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266699	11/14/2006	IL	7.0	7		F	11/09/2006	Nasal FluMist accidentally sprayed into eyes when child suddenly moved her head back. Family was contacted again 11/6/06; child is fine.									Y	11/04/2006	11/04/2006	0	NONE	PVT	PVT		NONE	NONE			1						1	Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~500437P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0266700	11/14/2006	MO	12.0	12		F	11/08/2006	Dizzy/lightheaded, blurred vision, muffled hearing, weak.									Y	11/08/2006	11/08/2006	0		PVT	PVT	Singulair 10mg	NONE	NONE			1						1	Asthenia; Dizziness; Hypoacusis; Vision blurred	FLU3~SANOFI PASTEUR~UT2174LA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266701	11/14/2006	LA	4.0	3		M	11/09/2006	Left thigh red and swollen, warm to touch, redness size of approx 3cm x 3cm. No fever/treatment-symptom care.				Y					Y	11/06/2006	11/06/2006	0	NONE	PVT	PUB	NONE	NONE	Bronchitis/Reactive Airway Disease			1						1	Erythema; Feeling hot; Swelling	FLU3~SANOFI PASTEUR~U2245AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266702	11/14/2006	VA	68.0	67		F	10/31/2006	7x20 cm area of erythema and induration at and distal to site of vaccination.									Y	10/30/2006	10/31/2006	1		PVT	PVT		NONE	rashes from sulfa, zyrtec, pencillin, doxycycline.			1						1	Erythema; Injection site induration	FLU3~SANOFI PASTEUR~U2164AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1044P~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266703	11/14/2006	MS	37.0	36		F	11/07/2006	Received flu vaccine 11-6-06 at 15:15pm and patient awoke on 11-7-06 she had reddened rash on both arms, legs and torso. And itching at those sites. Denies respiratory difficulty.										11/06/2006	11/07/2006	1		PUB	UNK	NONE	NONE	NONE			1						1	Erythema; Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA321AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0266704	11/14/2006	VA	63.0	63		F	11/08/2006	Awaken  2:00 am next am face and mouth felt funny not able to hold water in mouth. Grew worse Left eye unable to close by 6 am on 11-04-06. Head left side face left side severe headache severe pain left eye and behind left ear and entire left head. Symptoms remained 11-8-06. 11/15/06-records received from facility: DX acute maxillary sinusitis. Bellys Palsy, IDDM, hyperlipidemia, peripheral neuropathy, depression, hypokalemia, chronic pain right hip, emphysema, urinary stress incontence, chronic right knee pain, GERD.				Y						11/03/2006	11/04/2006	1	Patient reports was diagnosed by symptoms	PUB	UNK	Glucovance, Lantus, Regular Insulin, Indocin, Zantac PRN, Zoloft, Neurontic	Sinus headache constantly years	Bells Palsy 1986 to right side			1						1	Arthralgia; Depression; Diabetes mellitus; Eye disorder; Eye pain; Facial palsy; Gastrooesophageal reflux disease; Headache; Hyperlipidaemia; Hypokalaemia; Neuropathy peripheral; Sinusitis; Urinary incontinence	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFluA210AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0266705	11/14/2006	TX	68.0	68		F	11/02/2006	pneumococcal immunization given 9/13/06. Received email from patient on 11/2/06. Complained of itching at injection site since injection was given.										09/13/2006	09/13/2006	0	NONE	PUB	PVT	NONE	NONE	NONE			1						1	Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69480~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0877R~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266706	11/14/2006	NY	74.0	73		F	11/09/2006	Exactly 2 weeks after flu shot patient had a hacking cough, bad head cold, some fever, a few days later patient developed mump like swelling on left side of face and neck. Weakness. Could not get out of bed, tearing eyes.									N	10/07/2006	10/14/2006	7	Saw MD on 10/14/06 and received prescription for Augmentin.	OTH	PUB	NONE	NONE	NONE			1						1	Asthenia; Cough; Face oedema; Lacrimation increased; Nasal congestion; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA202BA~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0266707	11/14/2006	NY	84.0	84		M	11/09/2006	2 weeks after flu shot my husband had headache, sore throat, hacking cough and phlegmy cough, stuffy and runny nose, tearing eyes, weakness all over, couldn't get out of bed.									N	10/07/2006	10/14/2006	7		OTH	PUB	Captoprit fuerosimide, potassium	NONE	NONE			1						1	Asthenia; Headache; Influenza like illness; Lacrimation increased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~A202AB~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0266709	11/14/2006	WV	50.0	49		M	11/06/2006	Received Influenza vaccine at approx 0830AM. Remained under observation for 20 minutes then returned to work. At 9:50AM he returned to clinic site complained of difficulty taking a deep breath, felt like he was wheezing and that his throat was tight and had just vomited. B/P  /HR R-20. Epinephrine 0.1ml given SQ and Benadryl 50mg given IM at 9:52am. 10:10 reported relief in shortness of breath and throat tightness. EMS dispatched 9:52 immediately and arrived at 10:20A. He was assessed and declined transport to hospital. 10:30A- transported home. Instructed to seek immediate medical attention if symptoms returned.									Y	11/06/2006	11/06/2006	0	UNK	OTH	PVT		NONE	Penicillin, hypoglycemia			1						1	Dyspnoea; Throat tightness; Vomiting; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601511~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0266710	11/14/2006	OK	1.17	1	.2	F	11/07/2006	Hives									Y	11/04/2006	11/05/2006	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2196AA~UNK~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266711	11/14/2006	TX	92.0	92		F	11/03/2006	Local reaction redness, warmth, erythematous plaque, tenderness. Empiric treatment with Augmentin in case of _________process but not likely-resolved in 3 days.									Y	10/31/2006	10/31/2006	0	NONE	PVT	UNK	Fosamax, Levothyroxin, Isosorbide Mono, Hydrochbrt hypertension, Lovastztin, Atenolol, Aspirin, Oxytral Patch, Aleve		hyperlipidemia, osteoporosis, Coronary artery disease			1						1	Application site reaction; Erythema; Feeling hot; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70277~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0618F~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266713	11/14/2006	AK	0.5	0	.5	M	11/08/2006	Ears became thick and red, appeared as though they itched.  He also had a rash on trunk, legs and arms (wheal type lesions through out trunk, legs and arms). VS: Temp 37.8.  Tylenol was given 10 mg/kg and Benadryl 10 mg. 11/22/06 Received medical records from hospital which reveal patient seen in ER on 11/7/06 with rash & fever.  Had been seen in AM at PCP for well child visit & vax.  Ears became thick & red in afternoon & appeared itchy.  Also developed rash on trunk & extremities.  Low grade fever of 100.3 at home w/o treatment.  In ER temp was 100.0.  Exam revealed reddened, warm & mildly swollen ears.  There were several urticarial wheal type lesions throughout trunk, legs & arms.  Tx w/Benadryl & Tylenol in ER & symptoms resolved. Final DX: possible vaccine reaction vs environmental exposure to new shampoo & foods.				Y					Y	11/07/2006	11/07/2006	0	Urticaria	PVT	UNK		Healthy			AK200678	1						1	Erythema; Oedema; Pyrexia; Swelling; Urticaria	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B069AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2175GA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08691A~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0266714	11/14/2006	NJ	14.0	14		F	10/25/2006	Patient had erythema multiforme and arthralgia.				Y					Y	10/17/2006	10/19/2006	2	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Arthralgia; Erythema multiforme	FLU3~SANOFI PASTEUR~U2237AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266715	11/14/2006	MN	1.78	1	.8	M	11/02/2006	Fever and lethargy. Fussiness and cried all night.				Y					Y	11/01/2006	11/01/2006	0	NONE	PVT	UNK		NONE	History of prematurity, no sequelae of prematurity			1						1	Crying; Irritability; Lethargy; Pyrexia	FLU3~SANOFI PASTEUR~U2212AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266716	11/14/2006	OH	75.0	75		F	11/08/2006	Uper arm soreness after 28 days.									U	10/11/2006	10/11/2006	0		OTH	PVT						1						1	Myalgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA202AA~1~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0266719	11/14/2006	MI	49.0	49		F	11/05/2006	2 1/2 hours after getting the shot patient legs went numb and she couldn't walk due to throbbing, anything aching. Large red spots on her body.									N	10/31/2006	10/31/2006	0	Not yet, trying to get better on my own.	OTH	PVT	Dramorph	NONE	intersistyal cistitis-bladder disease			1						1	Difficulty in walking; Hypoaesthesia	FLU3~SANOFI PASTEUR~U2216AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266721	11/14/2006	MT	40.0	39		F	11/02/2006	Developed rash on trunk, legs, arms. No itching, fever, aches.									Y	11/01/2006	11/02/2006	1	NA	PUB	PVT	Prevacid, Dannatal	None	Allergy-Percocet, Lortab. Gall bladder sludge.			1						1	Rash	FLU3~SANOFI PASTEUR~U2193AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266722	11/14/2006	CA	1.49	1	.5	M	11/08/2006	Was given vaccines at approximately 9:30 am. At 8:30 pm had a fever and generalized seizure lasting 10-15 minutes. 11/21/06-office note for visit 11/8/06-febrile seizure at home temp 102. Previous seizure . Assessment viral versus febrile seizure.									Y	11/06/2006	11/06/2006	0	Had febrile seizure at age of 7 months	PVT	PVT		None	Asthma			1						1	Febrile convulsion	DTAP~SANOFI PASTEUR~C2649AA~4~IM~~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~V2176EA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB130AA~1~IM~~HEP A (HAVRIX)~1|HIBV~SANOFI PASTEUR~UE873AC~4~IM~~HIB (ACTHIB)~1	USA		Influenza
0266723	11/14/2006	PA	34.0	34		F	11/13/2006	Left arm with painful, local swelling involving entire upper arm began within 12 hours of immunization.									Y	11/08/2006	11/08/2006	0		PVT	PVT	Detace, Lo-oval, nepamax, multivitamin	NONE	Hypertension			1						1	Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2253AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266725	11/14/2006	CT	43.0	43		F	11/09/2006	Afebrile localized reaction left upper arm - reddened, hot to touch, swollen - underside left arm. Checked 5 hours later and redness. Tylenol/Ice; doctor notified. Reaction subsided 11/10/06 with itching only.									Y	11/07/2006	11/09/2006	2		PUB	OTH		NONE	NONE			1						1	Erythema; Injection site warmth; Swelling	FLU3~SANOFI PASTEUR~U2164AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266726	11/14/2006	MT	57.0	57		F	10/23/2006	Shot hurt when given. Did not feel well by 17:00. 21:00 temp 102.8 F through Sunday. Arm red, bruised (20cm), swollen at site (80cmX90CM) on Monday. Temp 97.5. Monday AM, took tylenol 2 tabs 500mg/eq. Ice applied.									Y	10/21/2006	10/21/2006	0	NONE	PVT	PVT	Glucophage; Zocor; Diovan	NONE	Type II Diabetes; Cholesterol; BP			1						1	Contusion; Injection site pain; Injection site swelling; Pyrexia	FLU3~SANOFI PASTEUR~U2177AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266727	11/14/2006	MO	29.0	29		F	11/07/2006	Vaccination given at 1420. That evening she developed increased temp, nausea, and hives. Swollen eyes and general malaise. She took Tylenol. At 0900 the next day she still had allergy symptoms. 25mg of Benadryl given. Symptoms decreased.									Y	11/06/2006	11/06/2006	0		OTH	UNK		NONE	Asthma; Heart murmur; All sulfa			1						1	Eye oedema; Malaise; Nausea; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U2202AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266728	11/14/2006	PA	4.0	4		F	11/09/2006	Large local inflammatory response 7cmX8cm with low grade temp 99. Tenderness to touch and increased warmth to touch. Patient had similar reaction last year.				Y					Y	11/07/2006	11/09/2006	2		PVT	UNK	NONE	NONE	NONE	Inflammatory response; low grade fever; tenderness to touch; increased warmth to touch.~Influenza (Seasonal) (no brand name)~~0.		1						1	Injection site inflammation; Injection site warmth; Pyrexia; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71640~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0266729	11/14/2006	TX	5.0	5		M	11/07/2006	Received FluMist on 11/3/06. Started breaking out in hives on 11/4/ and 11/5. Treated with Benadryl. DX: for DOS 11/16/06-urticaria, rule out strep. Possible reaction to FluMist. Strep negative. Note on 11/7/06-hives resolved. Entered note in patient chart allergy to FluMist.									Y	11/03/2006	11/04/2006	1	Strep test negative. performed on 11/6/06	PVT	PVT	None	None	None			1						1	Condition aggravated; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500433P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0266731	11/14/2006	CO	55.0	55		F	11/02/2006	Hives, low grade temp, body aches.									U	10/30/2006	10/31/2006	1	NONE	PUB	PVT	Lisinopril	NONE				1						1	Pain; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0391F~1~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266733	11/14/2006	NY	62.0	62		M	10/27/2006	About 9 hours after immunization, rather sudden fatigue, severe generalized myalgia with a sense of rigors though afebrile lasting about 6 hours. Never had similar reaction to prior flu or Td shots. Tdap was now this year shot site soreness was slight.									Y	10/26/2006	10/26/2006	0		PVT	UNK	NONE	NONE	NONE			1						1	Chills; Fatigue; Injection site pain; Myalgia	FLU3~SANOFI PASTEUR~U2199AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2609AA~UNK~IM~~TDAP (ADACEL)~1	USA		Influenza
0266744	11/14/2006	NY	72.0	72		M	10/31/2006	Cellulitis developed at injection site within 24h. Responded well to Keflex 500mg every 10 hours for 10 days.				Y					Y	10/24/2006	10/24/2006	0	NONE	PVT	OTH		hypertension	Food allergies (peanuts, chocolate)			1						1	Cellulitis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA220BA~UNK~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|UNK~UNKNOWN MANUFACTURER~0749F~UNK~~LA~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0266745	11/14/2006	NY	69.0	69		F	10/31/2006	Cellulitis developed at injection site within 24 hours. Responded well to KEFLEX 500 gram PO for 10 days.				Y					Y	10/24/2006	10/26/2006	2	NONE	PVT	OTH		HYPERTENSION, ANXIETY	Allergy to Codeine			1						1	Cellulitis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA220BA~UNK~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0749F~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0266751	11/14/2006	VA	1.25	1	.3	F	11/14/2006	Two febrile seizures within 10 days of the MMR/V. 01/25/07-ER records received. Temp in ER 96.5. In usual state of health except for some mild URI symptoms. In ER after 2 suspected febrile seizures. Seen initially at Arlington ED with temp 104.3, urine and blood tests negative. DC home late last night, at 2:00 am medicated with Tylenol at home, began seizure movement. Rash at injection site. ER notes indicates in FH recent chicken pox. DC summary not included.  01/25/07-Additional progress notes received,  Assessment:fever most likely either viral or secondary to the MMRV. Questionable febrile seizure first event much less typical second much more classic.				Y	Y	2			Y	11/01/2006	11/10/2006	9	12/13/06- Received lab reports CSF culture negative, Protein 28, lymphs 75, macrophages 25, glucose 73.  Chem WNL, glucose 108, CBC: WNL segs 68 and lymphs 25 Influenza antigen negative for influenza A and B antigen. UA WNL Blood culture: negative.RSV: negative.	PVT	PVT	NONE					1						1	Febrile convulsion	FLU3~SANOFI PASTEUR~U2174EA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~0976F~1~SC~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Hospitalisation	Influenza
0266752	11/14/2006	NM	59.0	59		F	11/14/2006	Severe chills, lot of pain all muscles-lasted 2 days. Headache, nausea.									Y	11/02/2006	11/02/2006	0		OTH	UNK	CRESTOR, LEXAPRO, FEUOFLURXINE	NONE	Allergies Lisinopril			1						1	Chills; Headache; Myalgia; Nausea	FLU3~SANOFI PASTEUR~49281037815~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~00006494300~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266755	11/14/2006	CO	58.0	58		F	11/14/2006	Shot given 11/12/06 at 12:20 pm, by 8pm arm swollen by 11/14/06. Red arm swelling, chills, fever and achiness went to primary doctor. Doctor gave antibiotics and Benadryl.				Y					N	11/12/2006	11/12/2006	0	Doctor visit	OTH	PVT	Bupropion 150 mg BID, Aciphex 20 mg QD	NONE	Depression			1						1	Chills; Pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U2218AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0485F~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0266756	11/14/2006	KS	77.0	76		M	11/14/2006	Client arrived at health department on 11-14-06 1pm to report: Had Influenza and Td vaccination on 11-07-2006, on Friday 11-10-06 approximately 1 am, started having bad cough, drainage from sinus, hoarseness, slight headache, this lasted until 11-13-06.										11/07/2006	11/10/2006	3	NONE	PUB	PVT	ASPIRIN 1 PO QD, LIPITOR 10mg PO QD, MULTIVITAMIN PO QD	NONE	NONE			1						1	Cough; Dysphonia; Headache	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71926~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~AVENTIS PASTEUR~U1943BA~4~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0266757	11/14/2006	MD	6.0	6		F	11/14/2006	Patient in the office, mom stated child had not received Flu vaccine, stated no illness, no allergies, no meds today. Vaccine given per protocol. Mom doesn't speak English, a paper was given to interpreter at end of visit. The paper stated that the child received Flumist on 11-13-06. Mom stated via interpreter that because the child did not receive a shot she did not think the child had the vaccine. Agency was contacted per agency, no adverse reaction should occur, 11-14-06 Fluvirin dose is void. Child is to receive dose #2 in 28 days from Flumist. Doctor and patients mother aware.										11/14/2006				PVT	PUB	NONE	NONE	NONE			1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~71827~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0266761	11/14/2006	AZ	11.0	11		M	11/14/2006	Severe body aches, headache, mild sore throat, site of vaccine red, hard, hot to touch, swollen to about the size of a baseball.  Fevers from 101.5 to 103.1 over three days that would not break with Tylenol or Motrin.  Nausea and vomiting for one day.									Y	11/07/2006	11/08/2006	1		UNK	UNK		None	None			1						1	Headache; Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth; Pain; Pharyngolaryngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~6~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~~1~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0266762	11/14/2006	NM	15.0	15		F	11/14/2006	20 minutes after the injection, the patient's first ever flu shot, she developed generalised erythema rash, facial sweeling and shortness of breath. This flu shot was done at a school site. Volunteer doctors (unspecified) and was attended by ER physician. She was given oral prednisolone for 4 days and albuterol inhalation at ER. 5 days after this episode in my clinic, she is well and normal peak flow.				Y					Y	11/09/2006	11/09/2006	0	Peak Flow at Day 5: normal.	UNK	UNK		Nil	Cephalosporins cause rash			1						1	Dyspnoea; Face oedema; Rash erythematous	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0266763	11/14/2006	NY	39.0	39		F	11/14/2006	5:58pm received fluzone, IM, L deltoid  6:10pm became flushed and began to feel tightness in throat - pt self administered one puff of albuterol inhaler.   6:12pm pt c/o stomach cramps and ongoing throat tightness, she self anministered epi-pen L thigh. BP 200/100 pulse=100 6:38 pt feeling a little better,and did not want ambulance called,but then stomach cramps started again, 911 was called. 6:45 2nd dose of IM epinepherine given as pt cramps getting worse (her typical symptom with anaphylaxis)sx subsiding by the time ambulance crew arrived at 7:00pm-pt transported to hospital.				Y					U	11/13/2006	11/13/2006	0		UNK	UNK	Zantac zyrtec	No acute illness	asthma Ideopathic Anaphylaxis x 3 years Allergy testing has only revealed mild environmental allergies, but anaphylactic reactions have occurred after eating. Pt's allergist had suggested pt get the flu vaccine this year, but to bring someone to drive her home and her epi-pen. Pt has received the flu vaccine for the last 2 years without incident			1						1	Abdominal pain; Blood pressure increased; Flushing; Heart rate increased; Throat tightness	FLU3~SANOFI PASTEUR~U2247AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266764	11/14/2006	GA	2.0	2	.0	M	11/14/2006	0.5 ml of flu vaccine given of the 36 months and older vacc.  Pt is only 24 months.  No reactions occurred as of yet.									Y	11/06/2006				UNK	UNK						1						1	Medication error	FLU3~SANOFI PASTEUR~70737~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266765	11/14/2006	MN	52.0	52		F	11/14/2006	Had shot at 330pm, went home and nose started terrific itching, and continued for 1 day. Called Pharmacist, and he thought reaction was from flu vaccine.That night felt drugged and almost called 911. Next am took Benadryl. Helped some. On 11\12 stopped Benadryl, itching subsided.									Y	11/10/2006	11/10/2006	0		UNK	UNK		none	Allergic to sulfa. Depression. Eczema as a child.			1						1	Pruritus; Sluggishness	FLU3~SANOFI PASTEUR~U2201BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266768	11/14/2006	MN	71.0	71		F	11/14/2006	CELLULITIS AT THE INJECTION SITE.				Y					Y	11/07/2006	11/10/2006	3	THIS IS INTERESTING AS BOTH THIS PATIENT AND HIS WIFE HAD THE SAME VACCINATION, SAME DAY, SAME NURSE & BOTH DEVELOPED CELLULITS AT THE INJECTION SITE. WE BELIEVE THIS PT HAD A DELAYED RX BECAUSE DELAYED HE WAS ON AN ANTIBIOTIC FOR DENTAL WORK. THE MORE CURIOUS THING IS THAT WE HAD A SIMILAR CASE OCCURR IN SEPTEMBER OF THIS YEAR. I JUST SUBMITTED THAT REPORT TODAY AS WELL.	UNK	UNK			CAD, ATRIAL FIBRILLATION			1						1	Cellulitis; Injection site reaction	FLU3~SANOFI PASTEUR~U1913aa~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0486f~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0266770	11/14/2006	CA	45.0	45		F	11/14/2006	WITHIN 6HRS OF INJECTION: VERTIGO/SYNCOPE, FEVER, EXTREME CHILLS/SHIVERS, NAUSEA, SIGNIFICANT SWELLING AT INJECTION SITE, HEADACHE, MUSCLE SPASM/WEAKNESS. TX'D WITH 800MG IBUPROFEN Q4-6H PRN PAIN/FEVER. WARM COMPRESS TO INJECTION SITE, PUSHED FLUIDS AS TOLERATED TILL NAUSEA SUBSIDED. VERTIGO/SYCOPE - 48HRS CHILLS/SHIVERS/FEVER - 72HRS MUSCLE SPASM/WEAKNESS - 48 HRS NAUSEA - 48 HRS SWELLING AT INJECTION SITE - 72 HRS PAIN AT INJECTION SITE - 96 HRS AND STILL PAINFUL HEADACHES - 96HRS AND STILL PAINFUL									Y	11/11/2006	11/11/2006	0		UNK	UNK	ALUPENT	NONE	ASTHMATIC			1						1	Chills; Headache; Injection site pain; Injection site swelling; Muscle spasms; Muscular weakness; Pyrexia; Syncope; Vertigo	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0266772	11/14/2006	IN	1.17	1	.2	F	11/14/2006	Mother states child with temperature of 100.9Ax on 11/13/2006.  RLE swollen, red, tight with no tenderness to touch. Child s/w 'fussy' today, with no temperature elevation. Recommended that child continue to receive Tylenol as needed and to apply ice to the site.  If no improvement within 2 days, child should be seen by physician.									U	11/13/2006	11/13/2006	0	none	UNK	UNK	none	none	none			1						1	Erythema; Irritability; Pyrexia; Swelling	DTAPH~SANOFI PASTEUR~u14709c~4~IM~RL~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~u2175ha~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266775	11/14/2006	CA	20.0	20		F	11/14/2006	3 days after flu shot, She developed headache, running nose, watery eyes, phlegm, sneezing and 1 day fever of 100 F. Up to today 11/14/06, she still has very bad running nose and watery eyes.									N	10/19/2006	10/22/2006	3	No	UNK	UNK	No	No	No			1						1	Headache; Lacrimation increased; Nasal congestion; Pyrexia; Rhinorrhoea; Sneezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71641~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266777	11/14/2006	FL	49.0	49		F	11/14/2006	TEN SECOND PERIODS OF VERTIGO, NAUSEA, AND HEADACHES, S/S HAVE PERSISTED FOR OVER A WEEK.									Y	11/08/2006	11/09/2006	1	N/A	UNK	UNK	N/A	N/A	N/A			1						1	Headache; Nausea; Vertigo	FLU3~SANOFI PASTEUR~U2178AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266780	11/14/2006	TX	0.0	44		F	11/14/2006	PATIENT INITIALLY PRESENTED WITH LARGE BRUISE APPROXIMATELY 2 INCHES IN DIAMETER, AND COMPLAINED OF SORENESS AND FEVER AT INJECTION SITE ABOUT 2 DAYS AFTER RECEIVING VACCINE.  I INSTRUCTED PATIENT TO CONTINUE TO MONITOR.  WITHIN A FEW DAYS, THE BRUISE WAS GONE , BUT AN INDENTION IN THE SKIN REMAINED AT THE SITE.									Y	10/23/2006	10/24/2006	1		UNK	UNK						1						1	Contusion; Injection site necrosis; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U2213AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266785	11/14/2006	OR	0.75	0	.8	M	11/14/2006	Local inflammatory reaction at vaccination site.									U	10/31/2006	11/04/2006	4	None required	UNK	UNK			NKDA			1						1	Injection site inflammation	DTAP~UNKNOWN MANUFACTURER~~UNK~IM~RL~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~RL~HEP B (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~UNK~IM~RL~HIB (NO BRAND NAME)~1	USA		Influenza
0266786	11/14/2006	TX	7.0	7		F	11/14/2006	SHORTLY UPON RECIEVING THE FLU MIST ONE OF HER CHEEKS SHOWED QUARTER SIZE RED MARK, THE NEXT DAY THERE WAS RED SPLOTCHES ON BOTH CHEEKS WAR TO THE TOUCH, BOTH ARMS WERE ALSO INFLAMMED AND SHE EXPERIENCED SLIGHT PAIN, NEXT DAY EVERYTHING WAS CLEARED UP, PT WAS GIVEN ZYRTEC AND COLD PACKS WERE ADMINISTERED BY MOM AT HOME.									Y	11/07/2006	11/07/2006	0	NONE	UNK	UNK	PT IS ON FLONAS AND ZYRTEC 5MG CHEWABLES DAILY	IN GOOD HEALTH NO FEVER	ALLERGIES	RED SPLOTCHES ON CHEECKS AND ARMS~Influenza (Seasonal) (FluMist)~1~7.90~In Patient		1						1	Erythema; Injection site inflammation; Pain; Rash maculo-papular	FLUN3~MEDIMMUNE VACCINES, INC.~500437P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0266787	11/14/2006	LA	65.0	65		F	11/14/2006	Immediately following vaccination the patient reported having a fever and feeling achy all over.  Her illness progressed over the next few day into a 'flu like syndrome'.  This never resolved and continued to progress.  Patient admitted to another hospital 17 days after receiving her annual influenza vaccination with total paralysis.  Patient was diagnosed by a neurologist with Guillian-Barre syndrome.  She received 5 days of IVIG and has experienced improvement in the paralysis.  12 days after hospital admission, she was transfered to an inpatient rehab unit.  11/16/06 Received medical records from hospital which reveal patient admitted 11/04/06 to acute floor of hospital with GBS.  She had developed cold & cough s/s, facial weakness & upper back pain approx 1 week s/p flu shot.  Speech with mild dysarthria & right 7th peripheral nerve impairment.  Dysesthesias in BLEs, DTRs areflexic in UE & LEs & decreased motor strength in RLE.  Patient also had complaints of N/V & RUQ epigastric pain.  Cardiac w/u was neg.  Consults by neuro, cardio & GI.  No D/C summary included with records.  Patient transferred to rehab unit for continued PT/OT/ST. PMH: HTN, migraine headaches, thyroidectomy,  Final Dx: GBS, mild per neuro consult./ss			Y	Y	Y	12			Y	10/17/2006	11/03/2006	17	LABS: Na 129	UNK	UNK	aldactone 50 mg qd, avapro 300mg qd; diltiazem SR 420 mg qd, singulair 10 mg qd, Tricor 145mg qd, premarin 0.625 mg qd		adverse effects: Statins - myopathy			1						1	Back pain; Cough; Dysarthria; Guillain-Barre syndrome; Hyponatraemia; Influenza like illness; Muscular weakness; Pain; Paralysis; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA211BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Life Threatening,Hospitalisation	Influenza
0266790	11/14/2006	CA	6.0	6		M	11/14/2006	Hives over most of body 4 days after immunization.									U	11/10/2006	11/13/2006	3	None	UNK	UNK	Albuterol Flovent	Some cold symptoms	Asthma			1						1	Urticaria	FLU3~SANOFI PASTEUR~V2252AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0245454	11/15/2006	CA	54.0	54		F	12/06/2005	Initial report received from a health care provider on 10/13/05. A 54 year old female received an IM, left deltoid, injection of Fluzone, lot number U1803AA, on 10/12/2005 at 12:00pm. Six hours later, she developed a sore throat and general malaise. She had no shortness of breath, no rash and no weakness. the pt was seen in an ER, but no treatments were given. Pre existing medical conditions, illness at the time of vaccination and number of previous doses were not reported. Information regarding other medications was unk. At the time of this report, the pt had recovered. the reporter in this case is the same as for cases 2005-02095, 2005-02110 and 2005-021111. Follow up information received on 12/5/05 from a health care provider. The case was reviewed, and there is no additional information. Further information is not expected.				Y					Y	10/12/2005	10/12/2005	0	NONE	PUB	UNK			Pre existing medical conditions, illness at the time of vaccination and number of previous doses of Fluzone were not reported. information regarding other medications was unk.		200502101	1						2	Malaise; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U1803AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0249763	11/15/2006	AL	3.0	2	.5	U	01/26/2006	A two year old patient received a .25ml injection on 05/Oct/2005. One hour and thirty minutes post-vaccination, the patient began vomiting. The patient vomited every 15 minutes for four hours. The patient was treated with emetrol and the vomiting stopped. Pre existing medical conditions, gender, illness at the time of vaccination, and route and site of administration were not reported. No diagnostic test were reported. At the time of this report, the patient had recovered. Follow up information received on 24 Jan 2006: Per the reporter, the patient received the Fluzone vaccination in the left thigh and this was his first dose. The patient had a Radioallergosorbent Test (RAST) completed (date not reported) and the result was 0.10, Class 1 or mild allergy. No further information is expected.									Y	10/05/2005	10/05/2005	0		PVT	PVT			Pre existing medical history was not reported. Follow up information received on 24 Jan 2006: At the time of this vaccination, the patient had no illnesses or previous vaccinations within four weeks.			1						2	Hypersensitivity; Vomiting	FLU3~SANOFI PASTEUR~U1743MA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0249890	11/15/2006	GA	1.02	1	.0	M	02/02/2006	Initial report received on 11/Nov/2005 from a health care professional. A 12 month old male patient, with no significant medical history, had received an intra-muscular injection of FLUZONE No Preservative '2005-'2006, lot number U17431A, in the left thigh, a subcutaneous injection of another manufacturer's vaccine, PROQUAD, lot number 0769R in the left thigh and an intra muscular injection of another manufacturer's vaccine, PEDVAX, lot number 0482R, in the right thigh on 07/Nov/2005. Per the mother, the patient developed a fever of 100.4 degrees Fahrenheit on 08/Nov/2005. His fever went down to 102.8 degrees Farenheit on 09/Nov/2005. The patient was seen in the physicians office that day and his temperature was measured at 103.0 degrees Farenheit. The patient was again seen by the physician on 10/Nov/2005 and his temperature was measured at 99.0 degrees Farenheit. Per the reporter, the patient was still irritable when seen by the physician on 10/Nov/2005. Relevant diagnostic test/laboratory data were collected (date not reported).The urinalysis was normal, the complete blood count was within normal limits and the urine culture results were not back at the time of this report. The irritability was still persisting at the time of this report. Follow up information received on 30/Jan/2006 from a health care professional. Per the reporter, the patient did recover from these events  (date not reported). The reporter reviewed the case and there is no additional information to provide at this time. No further information is expected.				Y					Y	11/07/2005	11/08/2005	1	Relevant diagnostic tests/laboratory data were collected (date not reported). The urinalysis was normal, the complete blood count was within normal limits and the urine culture results were not back at the time of this report.	PVT	UNK			Per the reporter, it is not clear if the patient had any illnesses at the time of vaccination. There were no pre-existing medical conditions or use of other medications at the time of the vaccination. The patient did not have any other vaccinations within four weeks prior to this vaccination.		200502426	1						2	Irritability; Pyrexia	FLU3~SANOFI PASTEUR~U1743IA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~MERCK & CO. INC.~0482R~UNK~IM~RL~HIB (PEDVAXHIB)~2|MMRV~MERCK & CO. INC.~0769R~UNK~SC~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~2	USA	Emergency room visit	Influenza
0250739	11/15/2006	OH	11.0	11		M	02/28/2006	An 11-year-old male patient with a pre-existing medical history, allergy to Ibuprofen/Aspirin and shellfish and who was taking Singulair, Advair, and Zyrtec D had received his third intramuscular injection of Fluzone SV 2005-2006 USP, manufacturer Sanofi Pasteur, Inc, lot numberU1753AA, in the left deltoid; his first dose of Menactra, manufacturer Sanofi Pasteur, Inc., lot number 1782AA in the right deltoid and his first dose of another manufacturer's Pneumoccocal vaccine, lot number 0605R, in the left deltoid.  Six and a half hours later, he developed a 16 x 20 cm induration with an edge of erythema, central pallor, and warmth to the left arm.  Seven and a half hours post vaccination, he additionally developed left arm swelling.  Twenty four hours post-vaccination he developed a four x four cm of erythema, swelling, and warmth at the Menactra vaccination site on the right arm.  The following day the symptoms on the left arm were unchanged.  No relevant diagnostic tests/laboratory data were collected.  At the time of this report, the patient had recovered from these events.  Follow-up information received on 21/Feb/2006 As per reporter the patient had no previous reaction to Fluzone in the past.  The swelling of the left arm stopped at the elbow and did not go past the joint.  Treatment included Zyrtec and cool compresses.  Since the date of the initial report the patient has had skin test for allergies.  As per reporter, the patient has recovered.									Y	01/16/2006	01/16/2006	0	Per the reporter, no relevant testing or laboratory work was completed.	PVT	PVT			The patient had no illnesses at the time of vaccination.		200600139	1						3	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth; Pallor; Dizziness; Erythema; Injection site oedema; Medication error; Nausea; Erythema; Feeling hot; Injection site induration; Injection site inflammation; Injection site reaction; Oedema peripheral; Swelling	FLU3~SANOFI PASTEUR~U1753AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1782AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PPV~MERCK & CO. INC.~0605R~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~651524/0605R~UNK~IM~~PNEUMO (PNEUMOVAX)~2|FLU3~SANOFI PASTEUR~U1753AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|MNQ~SANOFI PASTEUR~U1782AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~3|PPV~MERCK & CO. INC.~0605R~1~IM~LA~PNEUMO (PNEUMOVAX)~3	USA		Influenza
0257936	11/15/2006	TX	41.0	41		F	06/29/2006	Initial report received on 01/Jun/2006 from a health care professional. A 42 year old female patient with no reported concurrent illness had received an intramuscular dose of Fluzone SV 2005-2006 USP, lot number U1772AA, in the left arm on 10/Oct/2005 at 16:30 pm. 218 days, post-immunization, the patient was diagnosed with influenza type A via a flu test performed in the physicians office on 17/May/2006 at 10:00 am. On 19/May/2006, an antibody titer level was drawn on the patient and the results showed influenza type A and B with Ab less than eight on both. At the time of this report, the patient had recovered from the event. Follow-up report received on 23/Jun/2006 from a health care professional. As per the reporter, the patient had no history of adverse events following influenza vaccination. Concomitant medications at the time of vaccination included Armour Thyroid 60mg. and Z-max 2gm. per os, which was given on 10/10/2005. Following the onset of the symptoms on 17/May/2006,the patient was treated with supportive care. She had sequaleae of bronchitis, which was treated with axithromycin. A copy of the patient's laboratory report was provided. Antibody testing for influenza type A and type B were both determined to be in the range and were less than eight, which is the reference range. The patient recovered from the events on 31/May/2006. Further information is not anticipated.				Y					Y	10/10/2005	05/17/2006	219	17/May/2006: Flu test positive for influenza type A.; 19/May/2006: Antibody titer levels drawn showing influenza type A, Ab less than eight and influenza type B, Ab less than eight. Follow up received on 23/Jun/2006 included a copy of the laboratory report. Antibody testing for influenza type A and type B were both determined to be in range and were less then eight, which is the reference range.	PVT	PVT	Armour Thyroid, Z-Max		Per the reporter, the patient had no illnesses or known drug allergies at the time of vaccination on 10/Oct/2005. The patient had no vaccinations within four weeks of the vaccination on 10/Oct/2006. From follow-up information received on 23/Jun/2006, it was reported that the patient had no previous adverse events following influenza vaccination. Concomitant medications at the timeof vaccination included Armor Thyroid and Z-Max.		200601331	1						2	Drug ineffective; Influenza like illness; Bronchitis; Influenza like illness; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U1772AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1772A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0266791	11/15/2006	ID	51.0	51		M	11/14/2006	Patient complained of inflamed and hot left arm at site of injection.  Patient did not specify when the onset of these symptoms occured, but he required medical treatment from an urgent care facility 3 days after the vaccine was administered.				Y					Y	11/08/2006				UNK	UNK	N/A	None	N/A			1						1	Injection site inflammation; Injection site warmth	FLU3~SANOFI PASTEUR~U22158AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266800	11/15/2006		68.0	68		F	11/08/2006	Information has been received from a licensed practical nurse concerning a 68 year old female with sulfa, amoxicillin and Cephalexin monohydrate allergy and a history of pulmonary embolism who on 10/30/06 was vaccinated with Pneumococcal 23v polysaccharide vaccine (lot 651404/0352F). Concomitant therapy included influenza virus vaccine (manufacturer unspecified). On 10/30/2006, the pt experienced an injection site reaction with fever, swelling, achiness, decreased appetite, erythema and fatigue. The pt had been previously vaccinated with Pneumococcal 23v polysaccharide vaccine in 1995. The pt was treated with antibiotics, antihistamines and steroids. At the time of the report, the pts injection site reaction with fever, swelling, achiness, decreased appetite, erythema and fatigue persisted. Injection site reaction with fever, swelling, achiness, decreased appetite, erythema and fatigue were considered to be other important medical events (OMIC). Additional information has been requested.									N	10/30/2006	10/30/2006	0		PVT	OTH			Pulmonary embolism, sulfonamide allergy, allergic reaction to antibiotics.		WAES0611USA01030	1						1	Decreased appetite; Fatigue; Injection site erythema; Injection site swelling; Oedema; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0352F~2~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266822	11/15/2006	VA	50.0	50		F	11/13/2006	Client developed chest tightness 30 minutes after receiving vaccine but did not report it to nurse in health unit. Came to health unit 11/8/06 complain of redness, swelling, pain and itching at site of injection (left deltoid). Doctor checked site-not infected. Area cleansed with alcohol, hydrocortisone cream and cold pack applied. Client did not divulge that chest tightness was still present. She apparently took Benadryl at home 11/8 and it went away. re-checked 11/9, local reaction diminished. No more chest symptoms.									Y	11/07/2006	11/07/2006	0	NONE	OTH	OTH	LEVOTHYROID, RELAFEN, ALBUTEROL	NONE	SULFA, PCN, MYCINS			1						1	Chest discomfort; Injection site erythema; Injection site pain; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U2256AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266823	11/15/2006	CT	9.0	9		F	11/15/2006	Local 16 x 9 cm erythematous lesion around the injection site, warm to touch, no fissures or discharge noted.									Y	11/09/2006	11/10/2006	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Erythema; Injection site warmth; Skin ulcer	FLU3~SANOFI PASTEUR~U2164AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266833	11/15/2006	IN	74.0			U	11/10/2006	Initial report received on 07 November 2006 from a health care professional.  A 74-year-old patient (gender not provided), with a past medical history of hypothyroidism, had received an intra-muscular injection os FLUZONE SV '2006-'2007 USP, lot number U2242AA, on 23 October 2006. The route of administration was not reported.  The patient was taking Lipitor, Coumadin and Synthyroid at the time of vaccination.  Two days post-immunization, on 25 October 2006, the patient developed symptoms (symptoms were not reported).  At an unspecified amount of time later, the patient was evaluated by a physician and diagnosed with mesenteric adenitis.  The patient required hospitalization (dates were not reported).  Diagnostic tests revealed an increased liver function test, and an increased INR level.  At the time of this report, the patient had not recovered.					Y				N	10/23/2006	10/25/2006	2		PVT	PVT	Synthroid, Lipitor, Coumadin		The patient has a history of hypothyroidism, per the reporter, it was unknown if the patient had an concurrent illnesses, or vaccinations within four week of this vaccination on 23 October 2006.		200602976	1						1	Liver function test abnormal; Lymphadenopathy	FLU3~SANOFI PASTEUR~U2242AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0266838	11/15/2006	PA	55.0	55		M	11/15/2006	On 8 Nov 2006, at ~10:00 AM I received a free dose (I.M.) of infuenza vaccine administered by our Health Services department.  At ~8:30PM, the same day, I gean ito experience chills which manifested into uncontrollable shaking of my entire body.  This lasted for approximalety 2 hours.  I had no fever at that time.  The shaking subsided and I was able to go to sleep.  The next morning I awoke with a sever headache, 101.5 fever, muscles aches, and extreme lethargy. I said home and slpet most of the day.  pain killers did not help my feveror headache.  I couldn't eat any food.  The next day, Friday, 10 November 2006, I had the same symptoms.  i went to my docutor who agrred that it appreaded that I had vaccine-induced flu.  I also began to get diarrhea on this day. I started alternating my pain meds and that helped my headache and my fever started to come down.  By Sunday, 12 November 2006, I was able to begin taking solid foods.  I returned to work on 13 November 2006 but in a very lethargic state.  I still have some of the effects of this event.				Y					Y	11/08/2006	11/08/2006	0		UNK	UNK	none	none	none			1						1	Chills; Diarrhoea; Headache; Lethargy; Myalgia; Oral intake reduced; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0266841	11/15/2006	WI	54.0	54		F	11/15/2006	First noted signs at 6:00 AM, when she got out of bed. Felt arthritic. Aches in feet, ankles, all joints of hands and wrist. Swelling at injection site. site was puffy for about 1 inch in diameter. Red in center. No treatment. Still feels symptoms in feet and hands today. Particularly in proximal thumb joint. When standing whole foot hurts.									U	11/13/2006	11/14/2006	1	None at this time	UNK	UNK	Levothyroxin, Wellbutrin, Paxil,	None	Exercise induced asthma, Hypothyroidism, prior ablation and surgery.			1						1	Arthritis; Injection site erythema; Injection site swelling; Pain in extremity	FLU3~SANOFI PASTEUR~U1267AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266843	11/15/2006	PA	60.0	60		F	11/15/2006	Extreme fatigue 1 hour after the shot; followed by laryngitis, fever and upper respiratory infection which lasted 7 days so far at this writing.  At this writing my head is still stuffy and I have post-nasal drip.									N	11/08/2006	11/08/2006	0		UNK	UNK	Pravachol					1						1	Fatigue; Laryngitis; Postnasal drip; Pyrexia; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~2241AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266845	11/15/2006	MD	72.0	71		M	11/15/2006	Within 12 hours flue-like symptons of muscle ache, headache, chills, fatigue, cough, loss of appetite. In general, myalgia. Persisted with gradual improvement over 7 days. Shot given about 2PM on Nov. 4, 2006.									Y	11/04/2006	11/04/2006	0		UNK	UNK	vytorin, HCTZ, atenolol, klor-con	no	dust and pollen allergies			1						1	Anorexia; Chills; Cough; Fatigue; Headache; Influenza like illness; Myalgia	FLU3~SANOFI PASTEUR~u2251aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266846	11/15/2006	NY	34.0	34		F	11/15/2006	Aout 7 hours after receiving vaccine I was itching and noticed red bumps on my abdomen and back. I still have them (2.5 days later) only from my neck down to hips, occasionally itchy. I took benadryl one night but didn't seem to have any effect.										11/12/2006	11/12/2006	0	none	UNK	UNK	none	none	none			1						1	Erythema; Pruritus; Rash	FLU3~SANOFI PASTEUR~U2256AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266847	11/15/2006	MA	44.0	44		F	11/15/2006	Rec'd flu immunization for first time.  Screened at employee flu clinic prior to immunization, which did not contraindicate giving flu vaccine.  Approx 2 hours later at home, c/o swelling tongue, increased dyspnea, throat closing up  After taking Albuterol inhaler without relief, took Benedryl, 911 called, transported to local ER.  Rec'd followup care for anaphylaxis.				Y					Y	11/09/2006	11/09/2006	0		UNK	UNK			Asthma			1						1	Anaphylactic reaction; Dyspnoea; Throat tightness; Tongue oedema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70384~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0266848	11/15/2006	SC	43.0	43		F	11/15/2006	Special note:  Patient is a nurse in the immunization clinic.   Within 5 minutes after injection patient had itching at right arm injection site, chest tightness, and throat itching, shortness of breath.  Patient took two (2) puffs of Albuteral inhaler at 4:45 pm.  Experienced loud pulmonary wheezing at 5:30 pm.  Patient took Xophrenox per nebulizer x2 treatments consecutively.  Within the hour patient took 3rd Xophrenox treatment with decrease in wheezing and shortness of breath.  No problems at injection site other than itching which did not increase later in the day.  Patient also experienced cyanosis around mouth with wheezing episode.									Y	11/07/2006	11/07/2006	0	NONE	UNK	UNK	Desensitization injection every 3 weeks; Advair, Prevacid. History of asthma	NONE	Codeine, bee stings, mold, mildew, dust mites, trees, pollen, grasses, cats.  History of asthma		SC0622	1						1	Chest discomfort; Cyanosis; Dyspnoea; Injection site hypersensitivity; Pruritus; Wheezing	FLU3~SANOFI PASTEUR~U2245AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266849	11/15/2006	PA	0.0			M	11/15/2006	Localized redness as vaccine site then chest pain and shortness of breath.  Patient transported to the emergency department and then discharged home from ED.				Y					Y	11/09/2006	11/09/2006	0		UNK	UNK						1						1	Chest pain; Dyspnoea; Injection site erythema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71640~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0266850	11/15/2006	PA	3.0	3		F	11/15/2006	Mother noticed inward deviation of right eye on 11/1/06, immunization given 10/25/06. Patient had progressive vision loss starting 11/12/06. MRI shows multiple demyelinating lesions and bilateral optic neuritis, most likely diagnosis at this time is Acute Demyelinating Encephalomyelitis (ADEM). Further workup pending.  1/2/07 Received medical records from hospital which reveal patient admitted 11/13/06-11/17/06. HPI: 2-3 day hx of acute & worsening visual loss preceded by a 2 week hx of right eye deviation.  Initial s/s began w/preceding viral illness characterized by fatigue & low grade fevers.  Improved & given a flu shot.  Parent noted right eye medial deviation & was referred to ophthal but condition worsened prior to appointment & was admitted to hospital.  Began stumbling, could not feed herself & unable to complete play/puzzle tasks she had done previously.  Opthal exam in ER noted significant bilateral visual loss & inflammation of bilateral optic nerves.  Exam also revealed shotty cervical lymphadenopathy.  Treated w/high dose IV steroids.  Neuro, ophthal & neuro-opthal consults done.  Continued on tapering steroids on d/c to home.  Was to be followed by neuro, opthal clinics.  Although her vision improved in left eye to 20/160, right eye remained unchanged & was responsive only to hand movement with afferent pupillary defect & decreased right abduction.  It was not known if vision would be permanently impaired & family was referred to early intervention specialists.  FINAL DX: Acute Demyelinating encephalomyelitis.					Y	5			U	10/25/2006	11/01/2006	7	MRI with multiple foci of T2 hyperintense signal consistent with demyelination and optic neuritis. Lumbar puncture pending. Ophthamologic exam with significant bilateral vision loss and papilledema. LABS: head CT showed inflammaation of right half of optic chiasm & right pre chiasmatic nerve.  WBC on admit 15.9, sed rate 35.  CSF showed normal glucose & protein, WBC 8, 14 monos, 86 lymphs.  CSF IgG was 1.88.	UNK	UNK	none	viral syndrome (had been fatigued with low grade fever for about 1 week)	lacrimal canal stenosis, obesity Family hx: mother is s/p strabismus surgery as child & currently sees glaucoma specialist every 6 mos.			1						1	Blindness; Demyelination; Encephalitis; Optic neuritis; Strabismus	FLU3~SANOFI PASTEUR~U1765FA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0266852	11/15/2006	WI	72.0	72		F	11/15/2006	L arm swollen, red and experiencing pain.				Y					U	11/13/2006	11/14/2006	1	UNKNOWN	UNK	UNK	UNKNOWN	UNKNOWN	UNKNOWN			1						1	Erythema; Pain; Swelling	FLU3~SANOFI PASTEUR~U2217AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0391F~3~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0266853	11/15/2006	WI	25.0	25		F	11/15/2006	The evening after receiving the Influenza Vaccine patient was having SOB, fever, pale, dizzy and went to ER to be evaluated.				Y					Y	11/13/2006	11/13/2006	0	unknown	UNK	UNK	Advir 250/50 Albuterol inhaler 2 puffs prior to exercise	no	Asthma			1						1	Dizziness; Dyspnoea; Pallor; Pyrexia	FLU3~SANOFI PASTEUR~u2256aa~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266855	11/15/2006	MS	64.0	63		M	10/27/2006	PT STATED GOT FLU AND PNEUMONIA SHOT; WENT TO ER NIGHT OF INJECTION; WAS TOLD HE HAD CELLULITIS; WENT TO MD THIS AM AND GIVEN ANTIBIOTICS.				Y					Y	10/26/2006	10/26/2006	0	NONE	UNK	UNK		NONE	NONE		MS05014	1						1	Cellulitis; Injection site reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71826~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0607R~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0266856	11/15/2006	MS	20.0	20		F	11/06/2006	Received immunization around 9 a.m. 11/1/2006; Patient states she had pulse rate increase;  Chest pains; Trouble Swallowing; Rash all over from head to toe; itching; Tight hissing in Throat afternoon of 11/1/2006; Saw PMD and CNP 11/01/2006 afternoon.				Y					Y	11/01/2006	11/01/2006	0	EKG	UNK	UNK	Singular & Zyrtec	None	Seasonal allergies; Allergic to animals, hair, Tussin		MS06015	1						1	Chest pain; Dysphagia; Heart rate increased; Pruritus; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71826~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0266857	11/15/2006	CA	1.04	1	.0	F	11/15/2006	Routine physical 11/6/06.  Received flu vaccine for first time, Comvax#3, Prevnar#4 (fever to 101 after 2 month shots, none since).  Developed fever to 104 later that evening, 102.7 the following morning.  No other symptoms.  Seen 11/7/06.  No fever since follow-up visit 11/7/06.									Y	11/06/2006	11/06/2006	0	11/7/06 wbc 14.6  Hgb 11.4 HCT 34.7  Plt 312 55% lymphs 16% mono 29% gran	UNK	UNK						1						1	Pyrexia	FLU3~SANOFI PASTEUR~U2191BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0879F~3~IM~LL~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~Bo8670C~4~ID~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0266859	11/15/2006	FL	49.0	49		F	11/15/2006	The girl put the shot in too high - up in the shoulder, not in the deltoid muscle.  I am in excruciating pain.  The arm is limited in useage. I felt an excruciating pain in the arm and let her know, as she gave the shot, and she continued to place the drug in my arm. Information received from the annual follow up indicates recipient has not recovered. After I had received the shot-which she put in the wrong place-too high on the arm- into the shoulder joint-I could not use my arm for four months. I had intense pain. Granted the shot was placed wrong, but no one would believe me that it was the flu shot causing an inflammatory reaction in my joint. I cannot seem to get compensation for my injury. The pain has gotten better-it took a full year but my shoulder is weak and atrophied due to non-use. I lost a 1/2 year of work-can I get some compensation. Per 60 day follow up: Chronic bursitis of left shoulder - MRI explains: Fluid in the subacromial subdeltoid bursa in keeping iwth bursitis. Chronic low grad Left should pain with restricted range of motion and loss of strength-shoulder atrophy. Before the shot which she put too high I had no shoulder pain what so ever.								Y	N	10/24/2006	10/24/2006	0	I went to the doctor  on 10/25/06 while I still had the shot mark and bandaid on my arm and she verified that it was too high.	UNK	UNK		None	None			1						1	Bursitis; Hypokinesia; Pain; Vaccination complication	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0266862	11/15/2006	IN	51.0			F	11/15/2006	This case was reported by a healthcare professional and described the occurrence of tremor in a 51-year-old female subject who was vaccinated with influenza virus vaccine (FluLaval) for prophylaxis. The subject had received influenza virus vaccine in previous years with no subsequent adverse events.  On 09 November 2006 at 8:25 a.m., the subject received a dose of FluLaval.  On 09 November 2006 at 8:50 a.m., 25 minutes after vaccination with FluLaval, the subject experienced tremor, dizziness, and sweating.  The subject returned to the healthcare professional who had administered FluLaval.  The subject's blood pressure was elevated at 170/80 mm Hg and her blood sugar was decreased at 51.  The subject received juice, crackers and diphenhydramine hydrochloride (BENADRYL).  The subject then went to the emergency room and was released the same day. The healthcare professional considered the events were clinically significant (or requiring intervention).  The outcome of the events was not reported.  (OMIC)				Y					U	11/09/2006	11/09/2006	0	Blood glucose 11/9/06 51, blood pressure 170/80 mm Hg.	OTH	OTH					A0627339A	1						1	Blood glucose decreased; Blood pressure increased; Dizziness; Hyperhidrosis; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601311~UNK~~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0266870	11/15/2006	WA	68.0	68		F		Right arm sore, itching, swollen, bright red, hot to touch, very painful to touch, restricted motion. lasted approx 1 week.									Y	10/31/2006	10/31/2006	0		PVT	UNK			Diabetes.			1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth; Joint range of motion decreased; Pruritus; Erythema; Joint range of motion decreased; Myalgia; Pain; Pruritus; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71647~3~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0399F~1~~RA~PNEUMO (PNEUMOVAX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71647~3~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~0399F~1~~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0266871	11/15/2006	IL	91.0	91		U		Large red center, indurated surrounding, the injection site, occurred within a few hours of injections (right arm).									Y	11/06/2006	11/06/2006	0	NONE	PVT	PVT		Stuffy nose	hypertension, COPD, CHF, osteoarthritis.			1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U2196AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1048P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266872	11/15/2006	MA	65.0	65		F	11/14/2006	Vomiting 3-4 hours after vaccine administration and dizzy.									U	11/14/2006	11/14/2006	0		PVT	PVT		NONE	NONE			1						1	Dizziness; Vomiting	FLU3~SANOFI PASTEUR~U2164AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266911	11/15/2006	AZ	4.0	4		M	02/01/2006	Initial report received on 07-OCT-2005 from a health care professional. A 4-year-old male child patient with no reported medical history developed swelling in the left eyelid and injection site inflammation associated with redness, swelling and warmth in the right arm, although the nurse reported that the patient received influenza vaccine (FLUZONE SV 2005-2006, lot U1818AB) in the left deltoid on 04-OCT-2005. All the above mentioned events developed on the day of the vaccination. He had also received a hepatitis-A vaccine on 03-OCT-2005 in the left deltoid. Outcome was unknown at the time of the report. Follow-up information received on 30-JAN-2006 from a healthcare provider. The patient had no diagnostic testing and no treatments. Per the reporter, the patient had recovered.									Y	10/04/2005	10/04/2005	0		PVT	UNK			NONE		200502053	1						1	Eyelid oedema; Injection site erythema; Injection site inflammation	FLU3~SANOFI PASTEUR~U1818AB~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266912	11/15/2006	NJ	5.0	4		F	01/24/2006	Initial report received on 10-OCT-2005 from a health care professional in USA. A 4-year-old female child patient with a medical history of ongoing eczema in the thigh experienced injection site inflammation associated with swelling and redness in the left upper arm on 07-OCT-2005, the day after the influenza vaccine (FLUZONE SV 2005-2006) administration. It was reported that the administration with S/8 needle bunched site resulting in a subcutaneous administration. Her consulting physician prescribed Ibuprofen (MOTRIN) and antitituolic on 10-OCT-2005. The patient's condition was improving at the time of the report. She was taking multivitamins since an unspecified time. Outcome was not reported.									Y	10/06/2005	10/07/2005	1		PVT	UNK	Multivitamins				200502054	1						1	Injection site erythema; Injection site inflammation; Injection site swelling; Medication error	FLU3~SANOFI PASTEUR~U1810AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266913	11/15/2006	OH	72.0	71		F	11/18/2005	Initial report received from the patient on 07-OCT-2005. A 71-year-old female patient with a medical history of rheumatoid arthritis received an injection of Fluzone 5V 2004-2005, lot number not reported, in OCT-2004. The patient had received many previous doses. The route and site of injection were not reported. Three weeks post-vaccination, the patient started to feel weak and could not open door handles. She also felt fatigued. The weakness and fatigue level lasted for three months. Per the reporter, she was examined by her rheumatologist and placed on Enbrel. Per the reporter, her sedimentation rates were high during this time. Illness at the time of vaccination and other medications were not reported. At the time of this report, the recovery status was unknown.				Y					U	10/01/2004	10/21/2004	20	Unspecified date: high sedimentation rates, per the reporter.	UNK	UNK			The patient had a pre-existing history of rheumatoid arthritis.		200502055	1						1	Fatigue; Muscular weakness; Red blood cell sedimentation rate increased	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266914	11/15/2006	AK	37.0	37		F	02/22/2006	Initial report received from a patient who is a health care professional in the USA on 13/Oct/2005. A 37 year old female patient developed a metallic taste in her mouth, her BP was 120/101 and she felt fuzzy approximately 10-15 minutes after receiving the injection of Fluzone, lot number U1754AA in the right deltoid on 12/Oct/2005. Patient denied dizziness. Stated BP normalized 10-15 minutes later. Duration of the metallic taste and fuzzy feeling was two hours. No other signs or symptoms were reported. As per reported the patient recovered. Follow-up information received on 21/Feb/2006 from a health care provider. The case was reviewed, and the reported has no additional information.									Y	10/12/2005	10/12/2005	0		PVT	UNK			Patient is allergic to shrimp, Betadine, peanut butter. She is on no medication and had no illness at the time of vaccination. Patient had no vaccination within 4 weeks prior to receiving Fluzone on 12/Oct/2005.		200502084	1						1	Blood pressure increased; Dysgeusia; Feeling abnormal	FLU3~SANOFI PASTEUR~U1754AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266916	11/15/2006	NJ	3.0	3		M	12/27/2005	Initial report received from physician on the 17/Oct/2005. A three and half year old male child developed redness and swelling at the injection site down to the elbow after receiving the injection of Fluzone, lot number U1753AA in the right deltoid on 9/19/05. the pt received in concomitant Havrix, lot number AHABV0711AA in the left deltoid. The pt was seen by a physician on 9/21/05 and was started on Zyrtec and corticosteroids. As per reporter the pt completely recovered within hours. Follow up information received on 12/21/2005 from a health care professional. the route of administration of the Fluzone was IM. To previous dose of flu vaccine were received prior to this vaccination. The adverse events of redness and swelling did extend to the elbow. The pts adverse events were treated with Prelone one teaspoon times two days, then one half teaspoon times two days, then on fourth teaspoon times two days, then stopped. No further information is expected.				Y					Y	09/19/2005	09/20/2005	1		PVT	PVT			The pt has no known allergies. Denies per existing medical conditions, not on any medications and denies any illness at the time of vaccination. No vaccinations were received within four weeks of receiving Fluzone on 9/19/05. follow up information received on 12/21/05 indicated that the pt had not had any previous doses of flu vaccine prior to this vaccination. The pt also had no illness at the time of the vaccination. The pt had no other vaccinations within four weeks of this vaccination.		200502112	1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U1753AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHABV0711AA~UNK~~LA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0266917	11/15/2006	TX	74.0	74		F	01/10/2006	Initial report received from a Pharmacist on 10/17/05. A 74 year old female pt developed a hardened area at the injection site and bruising at the injection site which went down to the back of her arm, 24 hours after receiving the injection of Fluzone, lot number U1806AA on 10/13/05. Route and site of administration not report. The pt has a history of Alzheimer and is on medication which was not specified. She is also on Aspirin 81mg daily. Treatment was not reported. As per reporter, at the time of this report the pt had not recovered. Follow up information received from a health care provider on 1/9/06. The vaccination was administered IM in the left deltoid. The pt had received six previous doses. The pt recovered four or five days following the vaccinations.									Y	10/13/2005	10/14/2005	1		PUB	PUB	ASA		The pt has a history of Alzheimer and is on medication for this and also aspirin. No known allergies.		200502129	1						1	Contusion; Injection site induration	FLU3~SANOFI PASTEUR~U1806AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266918	11/15/2006	OR				U	02/27/2006	Initial report received from a nurse in the USA on 17-OCT-2005. A patient (gender and age not reported) complained of a metallic taste after receiving the injection of Fluzone. Route, site, lot number and date of administration not reported. Treatment and recovery status was not reported. Follow-up information received on 24-MAR-2006 from a health care provider. The event onset was OCT-2005. Per the reporter, the patient had recovered from the event, and there is no additional information available. Additional information is not expected. Same reporter in case 2005-02132.									Y		10/01/2005			OTH	OTH					200502131	1						1	Dysgeusia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266919	11/15/2006	OR				U	03/27/2006	Initial report of a cluster involving Fluzone was received from a nurse on 10/17/2005. It was reported that pts (specific number involved, gender and age not reported) complained of nausea and vomiting, fever, diarrhea and burning at the injection site after receiving the injection of Fluzone. Route site, lot number and date of administration not reported. Treatment and recovery status was not reported. Follow up information received on 3/24/06 from a health care provider. At the time of this report, the pt had recovered from the events. The case was reviewed, and no additional information was available. Same reporter in case 2005-02131.									Y					OTH	OTH					200502132	1						1	Diarrhoea; Nausea; Pyrexia; Thermal burn; Vomiting	FLU3~SANOFI PASTEUR~~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266920	11/15/2006	DE	51.0	51		F	03/21/2006	Initial report received from a pt (who is a nurse) on 10/18/05. A 51 year old, female pt experienced burning upon administration of 0.5ml of Fluzone given inadvertently in the left forearm Intra dermally. She also received Tubersol in the right forearm. Within 10 minutes, she developed redness and a rash covering her entire forearm. The injection site was warm to touch, swollen and itchy. At the time of the report, the rash had disappeared. The reaction site was not specified. It was not known if the other symptoms had resolved. She has not recovered.									Y	10/17/2005	10/17/2005	0		PUB	PUB	Fosamax, Lexapro, ASA, Vitamins, Advil.		NONE		200502136	1						1	Incorrect route of drug administration; Injection site erythema; Injection site hypersensitivity; Injection site oedema; Injection site rash; Injection site warmth; Pruritus; Thermal burn	FLU3~SANOFI PASTEUR~U1936AA~UNK~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266921	11/15/2006	ID	53.0	53		F	02/06/2006	initial report received from a pharmacist on 10/20/05. A 53 year old female pt developed lower back pain, right side radiating to the left side two days after receiving the IM injection of Fluzone, lot number U18811AA in the left deltoid on 10/4/05. The pt is on Vicodin which was prescribed for pain 2 months ago. The type of pain was not reported. The pt had no illness at the time of vaccination. Symptoms resolve don their own. No medical treatment prescribed and the pt did not see a physician. follow up information received on 2/3/06 from a health care provider. The pt did not have a previous history of back pain and had not done anything to aggravate her lower back within seven days prior to vaccination. The duration of the lower back pain was a week. The pt had received the flu vaccine every year for 20 years. Same reporter and reporting facility in cases 2005-02155, 2005-02157.									Y	10/04/2005	10/06/2005	2		OTH	UNK	Vicodin		Vicodin which was prescribed for pain 2 months ago. The type of pain was not reported. The pt had no illness at the time of vaccination. It is unk if the pt received any vaccinations within four weeks prior receiving Fluzone.		200502156	1						1	Back pain	FLU3~SANOFI PASTEUR~U1811AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266922	11/15/2006	ID	91.0	91		F	03/27/2006	A 91-year-old female patient developed lower back pain on the right side, radiating to the left side over a course of 2-3 days following the intramuscular injection of FLUZONE, lot # U18811AA in the left deltoid on 04-OCT-2005. The symptoms resolved on their own. No medical treatment was sought, and no diagnostic tests performed. The patient receives the flu vaccination yearly and is on sleeping pills. As per reporter the patient recovered. Follow-up information received on 24-MAR-2006 from a health care provider. The patient had no history of back problems, and the lower back pain she experienced lasted for 7-10 days. The patient indicated the pain was quite severe for three days after vaccination and got less severe day by day after that. She had not aggravated her lower back in any way prior to vaccination. The event did not require examination by a physician. Same reporter and reporting facility in cases 2005-02155 and 2005-02156.									Y	10/04/2005	10/06/2005	2		UNK	UNK			The patient denies any pre-existing medical conditions or illness at the time of vaccination. She is on sleeping pills. It is unknown if the patient received any vaccinations within four weeks prior to receiving FLUZONE. The patient receives the flu vaccination yearly.		200502157	1						1	Back pain	FLU3~SANOFI PASTEUR~U1811AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266923	11/15/2006	MD	61.0	60		F	01/30/2006	Initial report received from a nurse in the USA on 20-OCT-2005. A 60-year-old female patient developed a severe headache, stomach pains with diarrhea and a fever of 101 degrees Fahrenheit shortly after receiving the injection of Fluzone in the left deltoid on 18-OCT-2005. Treatment received not reported. At the time of this report, which is two days post immunization, the patient feels okay. The patient has received the influenza vaccination many times with no reactions. Follow-up information received on 27-JAN-2006 from a healthcare provider. The adverse event onset was one hour post-vaccination. The patient also experienced constipation. The patient has a history of asthma for which she takes Advair. The symptoms subsided 24-48 hours post-vaccination.									Y	10/18/2005	10/18/2005	0		OTH	UNK	ADVAIR		The patient had no pre-existing medical conditions and had no illness at the time of vaccination. The patient has received the influenza vaccination many times with no reaction. Additional information: the patient has a history of asthma.		200502168	1						1	Abdominal pain upper; Diarrhoea; Headache; Pyrexia	FLU3~SANOFI PASTEUR~01772AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266924	11/15/2006	CA	47.0	47		F	02/13/2006	Initial report received from a nurse practitioner in the USA on 21-OCT-2005. A 47-year-old female developed redness of her neck and face (no rash) and joint pains of her hands and elbows three hours after receiving the injection (route not reported) of FLUZONE, lot # U1818AB, in the left deltoid on 20-OCT-2005. As per reporter symptoms resolved with no medical intervention. Follow-up information received on 13-FEB-2006. There were no other vaccinations within four weeks of the date of vaccination. Additional information is not expected.									Y	10/20/2005	10/20/2005	0		PVT	UNK	SYNTHROID, ZOLOFT, NSAID		The patient has a history of hypothyroidism, depression, minor muscle injuries. She is on SYNTHOID, ZOLOFT, NSAID and minor muscle relaxants. The patient denies any illness at the time of vaccination. The patient received the flue vaccine seven years ago.		200502169	1						1	Arthralgia; Erythema	FLU3~SANOFI PASTEUR~U1818AB~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266925	11/15/2006	NY	41.0	41		F	02/28/2006	Case received from a healthcare professional in the USA on 24-OCT-2005 via the MIS/VIS under the reference number 05-0567. A 41-year-old female patient with a medical history of environmental allergy, asthma and hypothyroidism had received a dose of FLUZONE, batch number U1762AA in the left deltoid and a dose of PNEUMOVAX (batch number 0790P) in the right deltoid on 21-OCT-2005, and 24 hours post-vaccination, i.e. on 22-OCT-2005, she developed injection site cellulitis at left upper arm with raised red rash, fine rash on shoulder and back and with injection site pain. The patient did not complain of shortness of breath or chest pain. The cessation date of each symptom was not reported. The patient was receiving concomitant treatment as budesonide, Thyroid, albuterol, aciclovir (ZOVAREX) and cetirizin (ZYRTEC). The patient required a doctor visit. No relevant laboratory tests. She received intramuscular ceftriaxone (ROCEPHINE) and diphenhydramine hydrochloride (BENADRYL) per oo. Further details were requested. Follow-up information received on 03-FEB-2006 from a health care professional. Per the reporter, the patient received one dose of Rocephin for treatment of the event and then was started on Duricef by mouth. The patient had no history of food or drug allergy in the past. The patient did not return. Per the reporter, the patient recovered from these events at the time of this report.				Y					Y	10/21/2005	10/22/2005	1	NONE	PVT	PVT	RUNECORT (budesonide), THYROID, ALBUTEROL, ZOVAREX (aciclovir), ZYRTEC (cetirizin), PULMACORT (budesonide), DURICEF		The patient had a history of environmental allergy, asthma, hypothyroidism but no food or drug allergy. There was no illness at the time of vaccination. The patient received previous doses of FLUZONE but dates were not sure. No vaccines were received within four weeks prior to this vaccination.		200502175	1						1	Cellulitis; Injection site pain; Injection site reaction; Rash	FLU3~SANOFI PASTEUR~U1762AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0790P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0266926	11/15/2006	NJ	64.0	64		F	02/07/2006	Case received from a healthcare professional in the USA on 24-OCT-2005 via MIS/VIS under the reference number 05-0568. A 64-year-old female patient with a medical history of hypercholesterolemia, diabetes mellitus and hypertension had received a dose of FLUZONE, batch number U1828AA, in the right arm and a dose of PNEUMOVAX, batch number 0055R, in the left arm on 17-OCT-2005, and 24 hours post-vaccination, i.e. on 18-OCT-2005, she developed fever at 101, which reached 103 36 hours post-vaccination, dry heaves, chills and redness at the injection site extending under her arm. She did not present with any illness at time of vaccination. Her symptoms were resolved on unspecified date except the redness which was decreased to size of 50 cent piece. The patient was receiving concomitant treatment as diuretics, LIPITOR, ZEDIC, LISINOPRIL and GLIPIZIDE. The patient required a doctor visit. Patient outcome was not recovered. Further details were requested. Follow-up information received on 03-FEB-2006 from a healthcare provider. There was no illness at the time of vaccination. Concomitant medication is corrected from ZEDIC to ZETIA. Additional information is not provided.									N	10/17/2005	10/18/2005	1	Temperature, 101, 24 hours post-vaccination and 103 36 hours post-vaccination. No other data.	PVT	UNK	DIURETIC, LIPITOR, ZETIA, LISINOPRIL, GLIPIZIDE		The patient had hypercholeserolemia, diabetes mellitus and hypertension. She did not present with any illness at time of vaccination.		200502176	1						1	Chills; Injection site erythema; Pyrexia; Retching	FLU3~SANOFI PASTEUR~U1828AA~7+~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0055R~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266927	11/15/2006	MI	46.0	46		F	02/14/2006	Case received from a healthcare professional in the USA on 26-OCT-2005 via the MIS/VIS under the reference number 05-0576. A 46-year-old female with a medical history not reported had received a dose of FLUZONE, batch number U1762AA in the left deltoid on 17-OCT-2005 and 1 day later, i.e. on 18-OCT-2005, she developed a red, swollen arm, swollen lymph nodes, painful neck and low grade fever. The patient did not present with any illness at time of vaccination and received her last dose of influenza vaccine in 2003. Her symptoms were not resolved at the time of the report. The patient required a doctor visit. Further details were requested. Follow-up information received on 13-FEB-2006. Per the reporter, there is no additional information at this time. Additional information is not expected.				Y					N	10/17/2005	10/18/2005	1		UNK	UNK			Not reported. The patient did not present with any illness at time of vaccination. The patient received her last dose of influenza vaccine in 2003.		200502202	1						1	Injection site swelling; Lymphadenopathy; Neck pain; Pyrexia	FLU3~SANOFI PASTEUR~U1762AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266928	11/15/2006	PA				U	06/28/2006	Initial report received from a health care provider on 25-OCT-2005. A cluster of approximately 270 patients experienced a black dot at the injection site after receiving intramuscular deltoid injections of FLUZONE from either lot number U1753AA or lot number U1746AA. Attempts to wipe the black dot off were not successful. Per the reporter, alcohol swabs are used to prep the vials, and they use BD Precision Glide syringe / needles and regular BD non-safety syringe needles. Approximately 300 doses were administered, now change the needle after drawing up the dose, and the black dot no longer appears at the injectino site. Per the reporter, the status of the event was unknown. Follow-up information received on 16-JUN-2006. Per the reporter, the BD PRecision Glide needles were used to administer other products at the site adn the same result of a black dot was observed. Because of th is, the BD Precision Glide needles were changed to another type of needle, and the site no longer saw the black dots. Per the reporter, the event of black dot was definitely thought to be associated with the BD Precision Glide needles and not the FLUZONE vaccine. The events of black dot were reported as temporary and disappeared later on.									Y					PVT	UNK					200502212	1						1	Skin discolouration; Vaccination complication	FLU3~SANOFI PASTEUR~U1746AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266929	11/15/2006	MI				U	03/06/2006	Initial report received from a healthcare provider on 25-OCT-2005. A cluster of three patients experienced a black dot at the injection site after receiving an intramuscular deltoid injection of FLUZONE, lot number U1819AA, on an unknown date. The patients' ages, names, and dates of birth were not reported. Per the reporter, the black dot was noticed after injecting the FLUZONE. The reporter states the black dot wouldn't wipe off, and that she felt that it was an impression or outline from the diameter of the needle, not really a black mark on the skin. One inch 25 gauge needles and safety glide syringes are the devices used. This event occurred three times, and then the staff began using new needles for injection. There have been no additional occurrences since. They routinely use alcohol to prep the vial stopper. No adverse events have been reported from the three patients, and no patients have called back concerning the black dot at the injection site. The status of the patients' black dot was unknown. Follow-up information received on 22-FEB-2006 and 27-FEB-2006. Per reporter there is no additional information available. To the reporters' knowledge none of the patients had any adverse event except for the black dot at the site of administration. No further information expected.									U					PVT	UNK			Illness at time of vaccination, other medications and pre-existing medical conditions were unknown.		200502213	1						1	Skin discolouration; Vaccination complication	FLU3~SANOFI PASTEUR~U1819AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266930	11/15/2006	NC				U	11/28/2005	Initial report received from a health care provider on 25-OCT-2005. A cluster of approximately ten patients experienced a dark dot at the injection site after receiving an intramuscular deltoid injection of FLUZONE, either lot number U1819AA or U1824AA, on an unknown date. The patients' ages, names, and dates of birth were not reported. Per the reporter, the small dark dot didn't wipe off. She then noticed residual on the vial stopper after prepping the vial with an alcohol swab. The vaccine administrator felt the residue was on the needle after penetrating the vial stopper, and this is what left the dark mark at the injection site. This occurred in approximately ten patients out of 1000 patients immunized. They use Precision Glide syringes with 23 gauge one inch needles. None of the patients reported an adverse event. The status of the patients' dark dot was not reported.									U					UNK	UNK			Illness at the time of vaccination, pre-existing medical conditions and other medications were unknown.		200502214	1						1	Skin discolouration; Vaccination complication	FLU3~SANOFI PASTEUR~U1824AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266931	11/15/2006	OH	3.0	3		M	02/01/2006	Initial report received on 27 Oct 2005 from a health care professional. A 3 year old male child with no known allergies, history of asthma, failure to thrive and general abscess presented with eyes almost swollen shut few hours after the intramuscular influenza vaccine, lot no: U1838AA administration in the right thigh on 27 Oct 2005. The patient was seen by a physician, Benadryl was ordered. It was reported that the patient had a previous dose of the same vaccine last year. No other symptoms were reported. Patient's conditon got improved and he recovered at the time of the report. Follow up information received on 30/Jan/2006. Per the reporter, the patient had received an injection of Fluzone on 07/Feb/2005 and did not experience any reactions. At the time of the vaccination, the patient had Asthma, failure to thrive and a dental abscess. Patient was taking Amoxil for the dental abcess at the time of the vaccination. The patient experienced swollen eyes 30 minutes post vaccination and was treated for this with Benadryl 5mg/kg every six hours for 24 hours. No further information is expected.				Y					Y	10/27/2005	10/27/2005	0		PVT	PVT	Albuerol Prn, Amoxil		Follow up information received on 30/Jan/2006. The patient had no known allergies but did have asthma, failure to thrive and a dental abscess (being treated with Amoxil at the time of the vaccination) at the time of the vaccination. A previous Fluzone injection was given 07/Feb/2005 and no reactions were noted. No other vaccines were received within four weeks of this vaccination.		200502232	1						1	Eye swelling	FLU3~SANOFI PASTEUR~U1838AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266932	11/15/2006	FL				M	11/25/2005	Initial report received on 28-OCT-2005 from a healthcare professional in USA. A 4-year-old male child patient with no reported medical history received two doses of FLUZONE on 24-SEP-2005 and 25-OCT-2005, respectively. It was reported that, however, it was not the first time the patient received the vaccine. The patient did not experience any reaction following the first dose and complained of myalgia at an unspecified time. Physician stated that the patient had normal temperature upon examination. Patient also complained of nausea at an unspecified time and he was not recovered at the time of the report.				Y					N	09/24/2005				PVT	PVT					200502244	1						1	Myalgia; Nausea	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266933	11/15/2006	MI	46.0	45		F	02/14/2006	Initial report received on 28 Oct 2005 from a health care professional. A 43 year old female patient a medical history on no known allergies and denies medical conditions, felt as if her chest was expanding 3 hours following the influenza vaccine (Fluzone SV '2005-'2006) administration on 24 Oct 2005. The next day she woke up with a head ache and sore throat. On 28 Oct 2005, headache has been resolved but the sore throat became worse. The patient was complained of lymph node tenderness and she was not recovered at the time of the report. Follow up information received on 13/Feb/2006 from a health care provider. Per the reporter, there is no additional information at this time.				Y					N	10/24/2005	10/24/2005	0		UNK	UNK			No known allergies and denies medical conditions.		200502245	1						1	Chest discomfort; Headache; Lymphadenopathy; Pharyngolaryngeal pain; Tenderness	FLU3~SANOFI PASTEUR~U1762AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266934	11/15/2006	IN	48.0	48		F	03/21/2006	Initial report received on 31 Oct 2005 from a health care professional. A 48 year old female patient with a medical history on no known allergies and diabetes experienced vertigo approximately 4 hours after the influenza vaccine (Fluzone SV '2005-'2006) administration on 25 Oct 2005. She was sent to an emergency room, where she was evaluated by the Emergency room physician. The glucose test was within normal limits at an unspecified time. She was concomitantly administered with insulin pump and some other unspecified medications. Outcome was not reported. Follow up information received on 20/Mar/2006 from a health care provider. The patient has a medical history of insulin dependent diabetes mellitus type 1, hypertension and hypothyroidism. Per the reporter, the patient had received a double dose of the Fluzone vaccine on 25/)ct/2005. The site of administration was in the upper left arm. The patient has not had any recurring symptoms since October 2005. It has been recommended to the patient by her treating physician not to to received the Fluzone vaccination again. No follow-up appointments have been completed.				Y					Y	10/25/2005	10/25/2005	0	Glucose: within normal limits	PVT	PVT	Insulin pump		No known allergies, diabetes Type 1, hypertension, hyprothroidism. She has received annual vaccination with Fluzone.		200502248	1						1	Medication error; Vertigo	FLU3~SANOFI PASTEUR~U1828A~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266935	11/15/2006	VA	82.0			F	11/28/2005	An 82 year old female patient with a medical history of no known allergies developed slight dizziness and felt very much fatigued approximately 1-2 days after the influenza vaccine and Pneumovax administration on an unspecified date. The patient was not recovered at the time of the report.									N					UNK	UNK					200502280	1						1	Dizziness; Fatigue	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266936	11/15/2006	OH	62.0	62		F	11/30/2005	Case received from a healthcare professional in the USA on 03/Nov/2005. It is worth nothing that 4 other patient experienced similar reactions however only one report was made. A 62 year old female patient with a medical history of drug and fruit allergy and increase, had received on 27/Oct/2005 an intramuscular dose of influenza vaccine, batch number U1906AA, in the deltoid, and immediately after, she developed swelling at injection site and ecchymosis at injection site. Moreover, she became diaphoresic, red in color with increased heart rate. No epi was ever given. Her condition was improved but bruising and swelling at injection site persisted. The patient was allergic to peaches, PABA, sulfonamide and thiazides. She also had a history of blood pressure increased. The patient did not present with any illness at time of vaccination. She had annually received a dose of influenza vaccine for 11 years. She had concomitant treatment: baby ASA (3Xweek), enalapril (Vasotec), indapamid (Lozol), metoprolol (Toprol) and nifedipin (Procardia). Patient outcome was not recovered. Further information was requested. Follow up information was received on 15/Mar/2006 from a healthcare professional. Per the reporter, no epinephrine was given for these events, no lab was collected and it was felt that the causality of the reaction was food allergies. At the time of this report, the patient had recovered approximately one week post-vaccination around 03/Nov/2006. No further information is expected.									Y	10/27/2005	10/27/2005	0	No diagnostic tests/laboratory data was collected for these events.	PUB	PUB	BABY ASA, VASOTEC (enalapril), LOZOL (indapamid), TOPROL (metoprolol), PROCARDIA (nifedipin)		The patient had allergies to peaches, PABA (para-aminobenzoic acid), sulfonamides and thiazides. She also had a history of blood pressure increased. New information received on 15/Mar/2006: The patient had no illness at the time of vaccination. She had not received any other vaccinations within four weeks of this vaccination.		200502327	1						1	Contusion; Flushing; Heart rate increased; Hyperhidrosis; Injection site haemorrhage; Injection site swelling	FLU3~SANOFI PASTEUR~U1906AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266937	11/15/2006	SD	47.0	47		F	02/17/2006	Case received from a healthcare professional in the USA on 03/Nov/2005. A 47 year old female patient with no known allergies , had received on 29/Oct/2005 in intramuscular dose of influenza vaccine, batch number U1811AA, in the left deltoid, and 30 minutes later, she developed white fuzzy tongue and she complained of her mouth felt slimy. Moreover, 2.5 days post-vaccination, the patient developed nausea and vomiting. She did not take any medication and did not present with any illness at time of vaccination. Patient outcome was not reported. Further information was requested. Follow up information received on 02/FEB/2006 from a healthcare provider. The patient's recovery status is unknown. Follow up information received on 17/Feb/2006 from a health care provider. The patient's recovery status is unknown.									U	10/29/2005	10/31/2005	2		PUB	PUB			The patient had no known allergies. She did not take any medication and did not present with any illness at the time of vaccination.		200502328	1						1	Nausea; Tongue black hairy; Vomiting	FLU3~SANOFI PASTEUR~U1811AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266938	11/15/2006	CO	50.0	50		F	04/04/2006	A 50 year old female, with history of environmental allergy, upset stomach to eggs and asthma, had received an injection on left deltoid of influenza vaccine on 24-Oct-2005 AM. In the afternoon of the same day, she complained of shoulder pain. There was no history of injury. Then, she complained of whole arm pain, unable to raise arm laterally without pain. There was no numbness or tingling. She received corrective treatment with Tylenol, sling and ice. Patient's recovery status: not recovered. The patient has been rechecked 3 days later. Follow up information received on 03/Apr/2006. Per the reporter, the patient recovered from these events. No further information is expected.				Y					Y	10/24/2005	11/24/2005	31		PVT	UNK	Nasonex, Zyrtec, Advair, Singular, Atrovent, Alental		The patient had no illnesses at time of vaccination. Medical conditions: environmental allergy, upset stomach to eggs, asthma. She received concomitant medications such as Nasonex, Zyrtec, Advair, Singular, Atrovent, Alental.		200502336	1						1	Hypokinesia; Pain; Shoulder pain	FLU3~SANOFI PASTEUR~U1810AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266939	11/15/2006	CO	48.0	48		F	02/07/2006	A 48 year old female, with medical history of allergy to thimerosal in contact solution, fibromyalgia, restless leg, and irritable bowel, had received an injection of influenza vaccine FLUZONE (lot number U1811AA) in her left deltoid on 19-Oct-2005. 3 days later, she experienced extreme dry noses, eyes, skin. Also mouth, lips, teeth and sinuses were dry. She stated past history of allergy to thimerosal in contact solution. On 02-Nov-05, i.e. 11 days after beginning of symptoms, she saw a physician as symptoms were still persisting. Patient's recovery status: not recovered. Follow up received on 06/Feb/2006 from a health care provider. The patient was examined by her physician on 03/Nov/2005 and had rhinitis and dry sinuses which he attributed to medications that she is currently taking. The date of vaccination is amended to 21/Oct/2005, and the onset of the adverse events is amended to 24/Oct/2005. Per the reporter, the physician stated that the patient is recovered and that her symptoms were not a result of the vaccination.				Y					Y	10/21/2005	10/24/2005	3		PUB	UNK	LEVBID, REQUIP		The patient had no illnesses at time of vaccination. Medical history: allergy to thimerosal in contact, fibromyalgia, restless leg, irritable bowel. She took Zoloft as other medication.		200502339	1						1	Dry eye; Dry mouth; Dry skin; Rhinitis	FLU3~SANOFI PASTEUR~U1811AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266940	11/15/2006	KY	48.0	48		M	03/06/2006	A 48 year old male patient, with history of enlarged prostate, depression, chronic obstructive pulmonary disease, and gastroesophageal reflux disease, reported that he experienced severe burning as flu vaccine was injected. He received FLUZONE, lot number U1839AA, intramuscularly on right deltoid on 03-Nov-2005. Patient's recovery status: not reported. Follow up information received on 06/Mar/2006 from a physician. Per the reporter, the patient only complained of injection site burning. The patient never had any other reaction or toxicity to the vaccine injection. The patient did not miss work or go to the emergency room as a result of this injection. No further information is expected. The coding of burning sensation was updated to injection site burning due to this new information. At the time of this report the patient had recovered from these events.									Y	11/03/2005	11/03/2005	0		OTH	PUB			The patient had no illness at time of vaccination. He had no known allergy. Medical conditions: enlarged prostate, chronic obstructive pulmonary disease (COPD), gastroesophageal reflux disease (GERD). He received Wellbutrin (depression) and Omeprazole (GERD).		200502348	1						1	Injection site pain	FLU3~SANOFI PASTEUR~U1839AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266941	11/15/2006	AL				U	02/01/2006	5 patients out of 100 complained of persistent pain lasting approximately 2-3 weeks from shoulder to elbow, across the arm after they received Fluzone (lot unknown, date not reported). Follow up information received on 30/Jan/2006. Per the reporter, the orthopedic evaluation and the MRI indicated that the patient had an impinged nerve. The symptoms became noticeable at the time of the vaccination, but was not directly caused by the vaccination.									Y					UNK	UNK					200502400	1						1	Neuralgia; Shoulder pain	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266943	11/15/2006	MO				F	01/30/2006	A female patient with no reported age and medical history complained of weakness, felt hot, dizzy and achy approximately 3 to 5 hours following the influenza vaccine administration in the right deltoid on 08-Nov-2005. The patient stated, she felt out of commission and she complained of left arm numbness that quickly resolved. She developed slight redness in right arm at the injection site. Outcome was not reported. Follow up information received on 27/Jan/2006. The patient recovered. Additional information is not expected.									Y	11/08/2005	11/08/2005	0		PVT	PVT					200502429	1						1	Asthenia; Dizziness; Feeling hot; Hypoaesthesia; Injection site erythema; Pain	FLU3~SANOFI PASTEUR~~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266944	11/15/2006	WI				U	06/28/2006	It was reported that about half of 11,000 doses of influenza vaccine administered have resulted in a tiny black dot tattoo at injection site. Outcomes were not reported. Follow up information received on 03/Feb/2006 from a health care professional. Per the reporter, about half of more of 20,000 doses of the vaccine resulted in a tiny black dot tattoo at the injection site, not half of 11,000 doses as previously reported. None of the recipients had problems from this injections. It was not reported if the recipients had recovered from this event at the time of this report. Follow up information received on 08/Jun/2006 from a health care professional. As per the reporter, the case has been reviewed and there is no additional information. Further information is not anticipated. Follow up information received on 16/Jun/2006. Per the reporter, it was suspected that the needles were causing the previously reported event of black dot tattoo, but they can not rule out the possibility of a relationship with the vaccine since they have no further information.														PUB	PVT					200502438	1						1	Skin discolouration	FLU3~SANOFI PASTEUR~U1881AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266945	11/15/2006	TX	48.0	48		M	03/14/2006	A 48 year old male patient with a medical history of seasonal allergies developed very sore and painful clavicular and shoulder area, approximately 2-3 hours following the intramuscular influenza vaccine administration in the left deltoid on 19-Oct-2005. In the same evening, he experienced great difficulty in picking up his arm. This has improved slightly but pain wakes him at night at the time of the report. The symptoms were improving with Motrin and he has not been evaluated by a physician at the time of the reporter. Outcome was not reported. It was reported that, he was receiving the same vaccine yearly for may years. Follow up information received on 13/Mar/2006 from the patient. Per the reporter, the patient was seen by a physician on 15/Nov/2005 and it was determined that the patient was experiencing signs and symptoms of bursitis. The patient was then treated with diclofenac. His symptoms improved. In late December the patient was treated with nabumetone for a wrist injury, by the end of the second course of that NSAID, the patient had recovered from the shoulder pain. This was determined to be 09/Mar/2006. The adverse events were updated per this new information. The previous adverse events were placed as co-manifestations of the bursitis. The arm discomfort was changed to Joint range of motion decreased as this was better coding for the symptom. No further information is expected.				Y					Y	10/19/2005	10/19/2005	0		PUB	PUB	ALLEGRA; MULTIVITAMINS; NABUMETONE		Seasonal allergy, Fluzone annually for many years.		200502440	1						1	Bursitis; Shoulder pain; Sleep disorder	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266946	11/15/2006	WA				U	12/12/2005	The reporter provided us with the information that approximately 300 people experienced a grayish black dot at injection site, i.e. deltoid, immediately after receiving Influenza vaccine (Fluzone), batch numbers U1805AA and U1839AA, vanish point syringe/needles used. The reporter stated her arm was still having grayish black dot after her dose received on 03/Nov/2005. No reports of adverse events had been received to date and no other events were reported.									U					UNK	UNK			UNK		200502444	1						1	Skin discolouration	FLU3~SANOFI PASTEUR~U1805AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266947	11/15/2006	PA				U		8 patients presented with black dots following intramuscular injection of flu vaccine (FLUZONE, lot number U1807AA). Outcomes were not reported. Follow up information received on 25/Jan/2006. Per the reporter, at the facility were the vaccines were administered, the black dots were noted by the staff nurses and medical assistants on multiple days to an unknown number of patients. During their flu shot clinics there is typically only one nurse giving injections. Not until later, did they realize that they were all periodically seeing the same event. The black dots were so small that none of the patients were aware of the event and there were after injection reports of pain and swelling associated with the black dots. All the patient's recovered from these events at the time of this report. No further information is expected.									Y					UNK	UNK					200502445	1						1	Skin discolouration	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266948	11/15/2006	CO	10.0			F	03/21/2006	Case received from a healthcare professional in the USA on 14-NOV-2005 (MIS/VIS # 05-0660). A 10-year-old female patient had received an injection of FLUZONE with preservative (lot unknown) in OCT-2005. She developed (latency not reported) a local reaction with swelling, skin peeling and scaling. The patient had had three prior flu immunizations without any problem. Patient's recovery status not reported. Follow-up information received on 20-MAR-2006. Per the responsible physician the patient received FLUZONE, lot number U1846AA (expiry date 30-JUN-2006) on 10-OCT-2005. Patient recovered. No further information is expected.										10/10/2005				UNK	UNK			Patient medical history mild learning disability (mental retardation), scoliosis (surgery 1 month ago, prior to immunization). The patient had no known allergies. She did not take any other medications. She had had 3 prior flu immunizations without any problem. Family history: atopic disease.		200502446	1						1	Injection site swelling; Skin exfoliation	FLU3~SANOFI PASTEUR~U1846AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266949	11/15/2006	CT				F	12/21/2005	Initial report received on 14/Nov/2005 from a health care professional. A female patient had received an administration (route and site not reported) of Fluzone SV (lot number not reported) on an unspecified date. At an unspecified time later the patient developed eye problems (not otherwise specified). No further information was provided. Follow up information received on 21/Apr/2006 from a health care provider. The reporter indicates that she was unable to reach the patient and that no further information is available.									U					UNK	UNK					200502465	1						1	Eye disorder	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266950	11/15/2006	VA	42.0	42		F	01/30/2006	Initial report received on 15 Nov 2005 from a health care professional. A 42 year old female patient with no reported medical history developed metallic taste in her mouth 2 days following the intramuscular intramuscular influenza vaccine (Fluzone SV '2005-'2006), lot no: U1773AA, administration in the left deltoid on 10 Nov 2005. She was also on nix treatment for the lice occurrence. The patient was not recovered from the adverse event at the time of the report. Follow up received on 26/Jan/2006. Per the reporter, the patient was contacted on 23/Jan/2006 and then she reported that the metallic taste resolved approximately two weeks after the initial complaint. The patient further reports having altered taste problems after each uses of Nizoral shampoo that was prescribed by her physician for a scalp issue. The patient concluded that the reported taste issues were not caused by administration of the flu shot. The patient has recovered. No further information is expected.									Y	11/10/2005	11/12/2005	2		UNK	UNK	NIX		The patient uses Nizoral shampoo for a scalp issue.		200502467	1						1	Dysgeusia	FLU3~SANOFI PASTEUR~U1773AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266951	11/15/2006	MA				F	02/06/2006	Case received from a patient, who is a healthcare professional, on 16 Nov 2005. A female patient (age unknown) had received an injection of influenza vaccine (Fluzone, lot unknown), as yearly, in left deltoid on 14 Oct 2005. On 18 Oct 2005, i.e. 4 days later, she developed a bilateral rash on legs (thigh area) of purpuric appearance, which spread to arms, forehead, face and neck. She felt swollen when warm with burning sensation. There was no itching. The symptoms resolved approximately within 3 weeks. Follow up information  received on 03/Feb/2006 from a health care provider. No treatment was received, and there was no infectious disease investigation or etiological work-up.  The lot number is provided as U1753AA. The patient had not experienced symptoms following previous vaccinations.				Y					Y	10/14/2005	10/18/2005	4		PVT	UNK			The patient had no illnesses at time of vaccination. She had no egg allergy. It was unknown if the patient received other medication (she refused)		200502493	1						1	Purpura; Skin burning sensation; Swelling	FLU3~SANOFI PASTEUR~U1753AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266952	11/15/2006	CA	34.0	34		F	03/27/2006	Case not medically confirmed. Case received from a patient 16 Nov 2005. A 34 year old female patient had received a 1st dose of Fluzone (lot unknown) in her left arm on 07 Nov 05. 30 minutes later, she had hot, dizzy, headache and flushed. Within 24 hours, she developed sinus and urinary tract infections (urinalysis was performed). On 07 Nov 05, after infections occurred, she visited physician. The initial symptoms lasted half hour. Patient's recovery status: not reported. Follow up information received on 07/Feb/2006 from a health care professional. Per the reporter, the lot number of the Fluzone wa U1805AA and the vaccination was given on 04/Nov/2005 not 05/Nov/2005 as previously reported. After review of this case by the reporter there was no additional information available to add at this time. Follow up information received on 13/Mar/2006. Per reporte, the injection was given with a 5/8needle which was a medication error. The size of the patient and intramuscular route required a 1 needled. There were not cultures performed. The patient was followed up at a clinic. Reporter will be forwarding further follow up information. Follow up information received on 27 Mar 2006. Per the reporter, the case was reviewed, and there is no additional information at this time.				Y					U	11/04/2005				OTH	UNK			The patient had no illnesses at time of vaccination. Patient medical history: allergy (some medications), anxiety. She received lorazepam.		200502494	1						1	Dizziness; Feeling hot; Flushing; Headache; Medication error; Sinusitis; Urinary tract infection	FLU3~SANOFI PASTEUR~U1805A~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266953	11/15/2006	NJ	71.0	70		F	01/27/2006	Initial report received on 17 Nov 2005 from a health care professional. A patient with no reported age and gender experienced chills, shaking, eyes were running and sore throat almost 5 hours following the influenza vaccine (Fluzone SV '2005-'2006), lot no: U1916AA administration on 15 Nov 2005. On 17 Nov she had laryngitis. The patient was not recovered at the time of the report. Follow up information received on 26/Jan/2006. Per the reporter, the patient coincidentally contracted an upper respiratory disease at the time of the vaccination. The patient realized that the injection had no connection with her flu vaccination. No further information is expected.									N	11/15/2005	11/17/2005	2		PVT	PUB			many previous doses of Fluzone. Follow up information received on 26/Jan/2006. Per the reporter, the patient had an upper respiratory infection at the time of the vaccination.		200502508	1						1	Chills; Feeling cold; Lacrimation increased; Laryngitis; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U1916AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266954	11/15/2006	HI	1.13	1	.1	F	11/30/2005	Initial report received from another manufacturer, report number WAES0511USA00146, on 09-NOV-2005. A nine-month-old female patient received in the left thigh an injection of FLUZONE, lot number 01754AA, on 11-OCT-2005. The patient has a history of facial rash and eye discharge, and her mother was vaccinated with varicella virus vaccine while pregnant. The patient also has a history of febrile seizure and urinary tract infection on 28-SEP-2005. On the day of vaccination the patient had been constipated for one day, was afebrile and had completed cephalexin that was being taken for a urinary tract infection. Eighteen days post-vaccination, on 29-OCT-2005, the patient complained of constipation and fever for four days. The patient's vaccination history includes, on 29-OCT-2004, a first dose of IPOL, lot number X1006, given in the right thigh; a first dose of DAPTACEL, lot number C1996AA, given in the left thigh; a first dose of PREVNAR, lot number 495-721, given in the left thigh, and a first dose of COMVAX, given in the right thigh; a second dose of ACTHIB (dose one was a different product), lot number UE335AC, given in the left thigh; and a second dose of PREVNAR, lot number A7400E, given in the right thigh. Vaccinations received on 28-JAN-2005 include a third dose of DAPTACEL, lot number C2131AA, in the left thigh; a second dose of IPOL, lot number X1189, given in the left thigh; a second dose of COMVAX, lot number 6481423/0128P, given in the right thigh; and a third dose of PREVNAR, lot number A57562B, given in the right thigh. Vaccinations received on 29-MAR-2005 include a third dose of Hepatitis B virus vaccine (doses one and two were COMVAX, lot number 647593/0465P, given in the left thigh; and a first dose of FLUZONE, lot number U1381AA, given in the right thigh. Vaccinations received on 29-APR-2005 include a second dose of FLUZONE, lot number U1381AA, administered in the left thigh. The patient has a history of a previous adverse event recorded in case 2005-02398. At the time of this report, the patient's recovery status was unknown.									U	10/11/2005	10/29/2005	18	Urine culture from catheterized specimen greater than 100,000 cfu/ml of escheria coli.	UNK	UNK			The patient had a history of facial rash and eye discharge. The patient's mother was vaccinated with varicella virus vaccine while pregnant. The patient has a history of a febrile seizure and urinary tract infection on 29-SEP-2005.		200502514	1						1	Bacterial infection; Constipation; Pyrexia	FLU3~SANOFI PASTEUR~U1754AA~3~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266955	11/15/2006	NY	51.0	51		M	12/14/2005	Initial report received on 21-Nov-2005 from a health care professional in USA. A 51 year old male patient, who is a physician with a medical history of no known allergies and discoid lupus erythematosus developed urticaria on abdomen, arms, occipital scalp and sacrum approximately 2 days following the influenza vaccine (Fluzone SV 2005-2006) lot no:U1817AA in the right deltoid on 09-Nov-2005. He was also complained of digital swelling of toes and heels and also heel pain. He self diagnosed with Reiters syndrome:, self medicated since an unspecified time with zithromax, cipro and doxycycline but no steroids. The CBC, CMP, sedimentation rate, C-reactive protein and HIV negative at an unspecified time. he had not seen any of note that he was receiving Fluzone annually and concomitantly taking plaquenil since an unspecified time.									N	11/09/2005	11/11/2005	2	CBC CMP Sedimentation rate, C-reasstive protein and HIV negative	UNK	UNK	Plaquenil		No known allergies, discoid lupus erythematosus. Fluzone annually		200502533	1						1	Oedema peripheral; Pain in extremity; Reiter's syndrome; Urticaria	FLU3~SANOFI PASTEUR~U1817AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266956	11/15/2006	CO				M	03/22/2006	A male patient of unspecified age with a medical history of emphysema and asthma experienced cramping and diarrhea 10-15 minutes following eating, duration 4 days, the day he received influenza vaccine (Fluzone SV 2005-2006) lot no:U1871BA in an unspecified arm on 17-Nov-2005. The event began in the evening at 06.00 PM of the vaccination. Signs and symptoms still persisted at the time of the report in relation to eating. Follow up information received on 212/Mar/2006. The initial reporter advises that the patient did not received the flu vaccine at their facility. However, he has no additional information about the case and no contact information for the patient or his physician. Additional information is not expected in this case.									N	11/17/2005	11/17/2005	0		OTH	UNK			Emphysema and asthma, patient. was taking other medication but unknown		20052539	1						1	Diarrhoea; Muscle spasms	FLU3~SANOFI PASTEUR~U1871B~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266957	11/15/2006	VA	8.0	8		M	12/15/2005	Case received from a healthcare professional in the USA on 22/Nov/2005 via the MIS/VIS under the reference number 05-0699. This case is included in a cluster of 5 cases and is linked with an 08 year old male patient with no medical history noted had received on 05/Nov/2005 an intramuscular dose of influenza vaccine (Fluzone), batch number U1819AA in the deltoid and 2 days later, i.e. on 07/Nov/2005 he experienced redness and swelling from deltoid to back beyond shoulder and down to elbow with injection site warmth to touch per he mummy. The patient was recovered on unspecified date.									Y	11/05/2005	11/07/2005	2		UNK	PVT					200502543	1						1	Erythema; Feeling hot; Swelling	FLU3~SANOFI PASTEUR~U1819AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266958	11/15/2006	VA	1.0	1	.0	F	12/15/2005	Case received from a healthcare professional in the USA on 22/Nov/2005 via the MIS/VIS under the reference number 05-0700. This case is included in a cluster of 5 cases and is linked with 2005-02542,2005-02543,2005-02545 and 2005-02546 cases. A 1 year old female patient with no medical history noted had received on 05/Nov/2005 his first intramuscular dose of influenza vaccine (Fluzone), batch number U1819AA and 2 days later, i.e. on 07/Nov/2005 she experienced temperature at 100-100 degrees F, slight red and mild cold symptoms. It is worthy noting that the patient received her third intramuscular injection of Hepatitis B vaccine (other MFR), batch number 0336R in the left leg and her first subcutaneous injection of Varivax (other MFG), batch number 0427R in the left thigh on 26/)ct/2005. The patient did not present with any illness at time of vaccination. The patient was recovered on unspecified date. Follow up information received on 15/Feb/2006 from a health care professional. Per the reporter the patient had the injection in the left thigh. No relevant diagnostic tests/laboratory data were collected.									Y	11/05/2005	11/07/2005	2		PVT	PVT			None noted		200502544	1						1	Body temperature increased	FLU3~SANOFI PASTEUR~U1819AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266959	11/15/2006	VA	4.0	4		F	03/20/2006	Case received from a healthcare professional in the USA on 22/Nov/2005 via the MIS/VIS under the reference number 05-0700. This case is included in a cluster of 5 cases and is linked with 2005-02542,2005-02543, and 2005-02546 cases. A 4 year old female patient with no medical history noted had received on 05/Nov/2005 an intramuscular dose of influenza (Fluzone), batch number U1819AA and 1 day later, i.e. on 06/Nov/2005 she experienced fever at 102 degrees F, sore throat and increased body aches. She was on amoxicllin time 6 days per Mom. The patient was recovered on unspecified date. Follow up information received on 17/Mar/2006 from a health care worker. The site of administration of the vaccine was unknown. Per the reporter, the case was reviewed and there is no additional information at this time. Additional information is not expected.									Y	11/05/2005	11/06/2005	1		PVT	PVT			Amoxicillin times 6 days.		200502545	1						1	Pain; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U1819A~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266960	11/15/2006	NM	63.0	63		F	12/20/2005	Initial report received on 30-Nov-2005 from a health care professional in USA. A 62 year old female patient with ongoing knee and joint pain complained of severe leg pain on 29-Nov2005 i.e. the day after the influenza vaccine (Fluzone SV 2005-2006)), lot no:U1815AA administration in the right gluteal site. Consulting physician evaluated on 30-Nov-2005. Outcome was unknown at the time of the report.				Y					U	11/28/2005	11/29/2005	1		UNK	UNK			Right knee and joint pain at the time of the vaccination.		200502661	1						1	Pain	FLU3~SANOFI PASTEUR~U1815AA~UNK~~GM~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266961	11/15/2006	PA	33.0	33		F	02/14/2006	Initial report received on 07-DEC-2005 from a health care professional in USA. A 33 year old female patient with knee problem felt pain and burning immediately upon the intramuscular influenza vaccine (Fluzone SV 2005-2006), lot no:U1763AA administration in the left deltoid on 03-Nov-2005. The events persisted for 1 month 2 weeks, soreness arm appeared normal, 3 weeks injection site OK, pain with movement especially lifting since an unspecified time. The patient was taking altran and feldene. Outcome was not reported. Follow up information received on 30/Jan/20006. Per the reporter, the patient continued to experience occasional left deltoid pain. The patient had not fully recovered from these events at the time of this report. Follow up information received on 13/Feb/2006. There were no relevant diagnostic tests. At the time of this report, the patient had recovered.				Y					Y	11/03/2005	11/03/2005	0		PVT	UNK	Feldene				200502728	1						1	Pain	FLU3~SANOFI PASTEUR~U1763AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266962	11/15/2006	MS	30.0			F	12/21/2005	Initial report received on 07-Dec-2005 from a health care professional in USA. A 30 year old female patient with a medical history of no known allergies experienced nausea and dizziness at the beginning of the day of immunization with influenza vaccine (Fluzone SV 2005-2006), lot no:U1811AA in the month of Oct-2005. The symptoms gradually worsened and patient was not recovered at the time of the report.				Y					N					UNK	UNK					200502729	1						1	Dizziness; Nausea	FLU3~SANOFI PASTEUR~U1811AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266963	11/15/2006	OH	19.0	18		F	12/23/2005	Initial report received from a physician in the USA on 09/Dec/2005. An 18 year old female patient complained of pain at the injection site with numbness in the arm, pain in left upper chest and right breast with radiation into the back around the dermatome after receiving the injection (route not reported) of Fluzone, lot number U1869AA in the left deltoid on 08/Dec/2005. The patient was seen by the physician and treated with Benadryl and anti-inflammatories. The patient had no illness at the time of immunization. As per reporter, at the time of this report the patient had not recovered.				Y					N	12/08/2005	12/08/2005	0		PVT	PVT	Contraceptive		The patient is on birth control has no medical conditions and is allergic to fentanyl.		200502759	1						1	Breast pain; Chest pain; Injection site pain	FLU3~SANOFI PASTEUR~U1869AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266964	11/15/2006	IA	59.0	59		M	02/01/2006	Initial report received from a pharmacist in the USA on 09/Dec/2005. A 59 year old male patient developed pain at the injection site three days after receiving the intramuscular injection of Fluzone, lot number U1803AA in the left arm on 02/Nov/2005. Two weeks later the patient visited his Primary care physician and complained on tingling fingers and pain in the entire left arm. The patient had no illness at the time of vaccination and has received the flu vaccine previously. As per reporter the patient had not recovered at the time of this report. Follow up information received on 30/Jan/2006. The case was reviewed and no additional medical information is provided.									N	11/02/2005				UNK	UNK			The patient had no illness at the time of vaccination and has received the flu vaccine previously. It is unknown if the patient was on medication, had any pre-existing medical conditions or allergies.		200502763	1						1	Abdominal pain; Injection site pain; Paraesthesia	FLU3~SANOFI PASTEUR~U1803AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266965	11/15/2006	NY	47.0	47		F	12/28/2005	A 47-year-old female patient with no known allergies or illnesses at the time of vaccination had received an administration (route and site not reported) of FLUZONE  SV '2005-'2006 USP on 04/Nov/2005  On 08/Nov/2005 she complained of feeling unsteadiness She said she did not feel unsteady on her feet, she felt unsteady in her head.  She was seen by a physician.  It is unknown if the patient recovered from this event at the time of this report.									U	11/04/2005	11/08/2005	4		PVT	PVT	LEVOTHYROXINE, ECOTRIN, VITAMIN E, VITAMIN C, L-LYSINE, RED POST RICE		Patient denies any illness at the time of vaccination/. The patient had no known allergies.  She was taking Levothyroxine, Ecotrin, L-Lysine vitamin E and C and red post rice at the time of the vaccination.		200502799	1						1	Balance disorder; Head discomfort	FLU3~SANOFI PASTEUR~U1773AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266966	11/15/2006	NE	1.1	1	.1	F	03/23/2006	Initial report received from health care professional on 17/Dec/2005 A 13-month-old female with no pre-existing medical history, had received a second dose injection, (route and site of administration not reported), of FLUZONE SV '2005-'2006 manufacturer Sanofi Pasteur, lot number U1761AA on 14/Dec/2005.  Within 24 hours, she experienced a fever of 104.9 and the 102.9 degrees Fahrenheit.  The event required a doctor's visit, and she was treated with Ibuprofen.  The patient had no focal or neurological problems.  She had no vomiting or rash.  Blood cultures were negative.  At the time of the initial report, the patient had not recovered.    Follow-up information received on 21/Mar/2006 from a health care provider  The second dose FLUZONE vaccination was administered in the right thigh.  The patient had reported that three hours hours later she developed a temperature of 104 degrees Fahrenheit and was irritable  The patient was examined by a physician two days post -vaccination on 16/Dec/2005 for acute onset of fever.  The patient had received Tylenol shortly before presenting to the clinic, and at that time, her temperature was 103.6,  On exam, she was slightly listless, apathetic with no respiratory distress.  Lab Tests performed on 16/Dec/2005 showed a cath UA that was negative.  CBC-white count 10.6 (differential: 14% bands, 56% segs, 2% eosinophils, 10% monocytes, and 8% lymphocytes), hemoglobin 12.3, hematocrit 35.9, and platelets 274,000.  The patient was administered Rocephin 500 mg, intramuscularly.   One 17/Dec/2005 the patient was again examined.  Her maximum temp since receiving Rocephin had been 102.8.  Mom states that her daughter has had increasing irritability over the past eight hours, but is drinking better.  She was given Motrin, last dose at 04:00.  She has not had any vomiting or diarrhea, and had good urine output.  No other family member has been ill.  Mother stated that the day prior after her daughter was given Motrin,she did standup but had a hard time walking.  She had not observed any seizure activity or focal neurologic symptoms.  No skin rashes were noted and no meningeal signs were demonstrated.  Oxygen saturation was 97% on room air and hear rate of 140 and BP 82/56.  On 17/Dec/2006 CRP was 2.5.  White count was 2500 with 42% lymphocytes, 36% segs, and 14% bands.  Platelet count was stable at 225.   Hemoglobin was 10.4 grams, SGPT was normal at 21 and SGOT elevated at 75.  Blood and urine cultures were negative after 24 hours, and throat cultures were negative after 48 hours.  Repeat Rocephin 500 mg. was administered intramuscularly. On 19/Dec/2005, the patient's fever had subsided.  She had developed a red macular rash which did blanche.  She is very alert and playful today.  Appetite is stable.  For the reporter, the working diagnosis was systemic viral infections with viral exanthema versus vaccine induced fever and rash.  At the time of this report, the patient had recovered from the events. Prior to these events on 10/Nov/2005, the patient had received an intramuscular injection of FLUZONE (dose one) lot number 01814AA in the left thigh Measles, Mumps, and Rubella (dose one), manufacturer, Merck, lot number 0625R in the left thigh.  Following these immunizations the patient had experienced loose stools and low-grade temperatures for five days  The reporter for this case is the same as for case 2005-02808				Y					Y	12/14/2005	12/14/2005	0	The patient had blood cultures and they were negative	PVT	PVT			The patient denies any illnesses at the time of the vaccination.  The patient has no known allergies and had no significant medical conditions and was not using any other medications at the time of the vaccination.		200502803	1						1	Apathy; Aspartate aminotransferase increased; Diarrhoea; Difficulty in walking; Haemoglobin decreased; Irritability; Listless; Neurological symptom; Pyrexia; Rash; Rash macular; Viral infection; White blood cell count decreased; Apathy; Aspartate aminotransferase increased; Diarrhoea; Difficulty in walking; Haemoglobin decreased; Heart rate increased; Irritability; Listless; Lymphocyte morphology abnormal; Pyrexia; Rash; Rash erythematous; Tachycardia; Viral infection; White blood cell count increased	FLU3~SANOFI PASTEUR~U1761A~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1814A~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0266966	11/15/2006	NE	1.1	1	.1	F	03/23/2006	December 16, 2005 - A cath UA that was negative.  Culture negative, blood culture negative, CDC - white count 10.6, hemoglobin 12.3 A 13 month female patient with no significant medical history, had received her first administration of FLUZONE SV '2005-2006 USPC, lot number U1814AA (route and site not reported); an administration of another manufacturer's MEASLES, MUMPS, AND RUBELLA VACCINE, lot number 0578 R (route and site not reported); and an administration of another manufacturer's VARIVAX vaccine, lot number 0625R (route and site not reported) on 10/Nov/2005.  Approximately tow days later, she developed loose stools.  She was afebrile.  The patient subsequently received another administration of FLUZONE SV'2005-'2006' USPC, lot number U1761AA (route and site not reported) on 14/Dec/2005.  The patient had not recovered from this event at the time of this report.  The patient had received Tylenol shortly before presenting to the clinic and at that time her temperature was 103.8.  On exam she was slightly listless, apathetic with no respiratory distress.  Heart was tachy, other wise regular rhythm, no murmur.   Lab tests performed on 16/Dec 2005 showed a cath UA that was negative.  CBC - white count 10.6, hemoglobin 12.3, hematocrit 35.9, platelets, 274,000.  Differential 14% bands, 56% segs, 2% eosinophils, 10% monocytes, and 8% lymphocytes.  The patient was given 500 IM Rocephin prior to dismissal and asked to follow-up the next day with a repeat CBC. On 17/Dec/2005 the patient was seen again.  She was given Tylenol and the temperature did initially decrease but then spiked up to 104.9 twice over the following 24 hours.  Her maximum temp since receiving Rocephin has been 102.8.  Mom states that her daughter has had increasing irritability over the past eight hours, but is drinking better.  She was given Motrin, last does at 04:00.  She has not had  any vomiting or diarrhea.  Good urine output.  No other family members have been ill.  Mother stated that the day prior after her daughter was given Motrin she did stand up but had a hard time walking.  She has not observed any seizure activity or focal neurologic symptoms.  NO skin rashes noted.  No meningeal signs demonstrated.  Oxygen saturation 97% on room air with a heart rate of 140, BP 82/56.  On 17/DEc/2005 CRP was 2.5.  White count was 2500 with 42% lymphocytes, 36% segs, and 14% bands.  There were a few lymphocyte variants present.  Platelet count was stable at 225.  Hemoglobin was 10.4 grams, SGPT was nomal, SGOT elevated a t75.  Blood and urine cultures negative after 14 hours.  Ibuprofen will be continued and encouraged fluids.  Rocephin 500 mg IM with the throat cultures negative for 28 hours. On 19/Dec/2005 the physicians spoke with the mom.  Her daughter's fever subsided yesterday.  She did break out in a red macular rash with did blanche.  She is very alert and playful today.  Appetite is stable.  Per reporter, the working diagnosis therefore is systemic viral infection with viral exanthema versus vaccine induced fever and rash.  Given the fact that the patient had a similar response after the first flu shot, it was recommended to withhold further flu vaccinations at this time.  ON 21/Mar/2006 the reporting physician called Sanofi Pasteur and reported the patient recovered.  Date of recovery not reported.  No further information expected.  The reporter for this case is the same as for case 2005-02803.  Follow-up information received on 21/Mar/2006 On 10/Nov/20005, the patient received the intramuscular injection of Fluzone (dose one) lot number U1814AA in the left thigh and the injections of Measles, Mumps, and Rubella (dose one), manufacturer Merck, lot number 0578R in the right thigh, and Varivax (dose one), manufacturer MERCK,  lot number 0625R in the left thigh.  Following these immunizations, the patient had a low-grade fever for about five days.  No other symptoms were reported.  The patient received the second dose of Fluzone, lot number U1761AA on 1/Dec/2005 which was administered intramuscularly int he right thigh.  Mom reported that approximately three hours later her daughter developed a temperature up to 104 (rectal) and was quite irritable.  She was seen by a physician on 16/Dec/2005.  The				Y					Y	12/14/2005	12/14/2005	0	December 16, 2005 -  A cath UA was negative.  Culture negative.  Blood culture negative. CBC- white count 10.6, hemoglobin 12.3, hematocrit 35.9, platelets 274,000.  Differential 14% bands, 56% segs, 2% eosinophils, 10% monocytes,and 8% lymphocytes.  December 17, 2005 - Oxygen Saturation was 97% on room air with a heart rate of 140, BP 82/56.  On 17/Dec/2006 CRP was 2.5.  White count was 2500 with 42% lymphocytes, 36% segs, and 14% bands.  There were a few lymphocyte variants present.  Platelet count was stable at 225.  Hemoglobin 10.4, SGPT normal, SGOT elevated at 75.  Blood and urine cultures negative after 24 hours.	PVT	PVT			The patient denies any illnesses at the time of vaccination.  She has no known allergies and no significant medical conditions.  The patient denies any use of other medications.   Fluzone (dose one) lot number U814AA and the injections of Measles, Mumps, and Rubella (dose one), manufacturer MERCK, lot number 0578R and Varivax (dose one), manufacturer MERCK, lot number 0625R.  Following these immunizations the patient had a low-grade fever for about five days.	Fever~Influenza (Seasonal) (Fluzone)~1~1.00~In Patient	200502808	1						2	Apathy; Aspartate aminotransferase increased; Diarrhoea; Difficulty in walking; Haemoglobin decreased; Irritability; Listless; Neurological symptom; Pyrexia; Rash; Rash macular; Viral infection; White blood cell count decreased; Apathy; Aspartate aminotransferase increased; Diarrhoea; Difficulty in walking; Haemoglobin decreased; Heart rate increased; Irritability; Listless; Lymphocyte morphology abnormal; Pyrexia; Rash; Rash erythematous; Tachycardia; Viral infection; White blood cell count increased	FLU3~SANOFI PASTEUR~U1761A~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1814A~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0266968	11/15/2006	IA	58.0	58		M	08/11/2006	Initial report received on 09/jan/2006 from a physician. A 58 year-old female patient with no pre-existing medical history received an intramuscular injection of Fluzone SV 2005-2006, manufacturer Sanofi Pasteur, lot number U1794AA, on 10/Nov/2005.  Site of administration was not reported.  On the same day, she developed tendonitis and neuritis of the left shoulder.  Physical exam of the shoulder revealed a decreased range of motion, decreased extension and 4/5 strength of the left upper extremity.  Other medication were none and there were no illnesses at the time of vaccination.  At the time of this report, the patient had not recovered although the reporter indicated that the patient is in the process of recovering.  Follow-up information received on 22/Feb/2006 Fluzone was administered in the left upper arm (deltoid). Per reporting physician (who is from patient's plan) she saw the patient on 02/Jan/2006.  The patient related a history of soreness and a knot which developed approximately 1 inch x 0.5 inches, in the general area of where the flu shot was given in the left upper arm followed by achiness, decreased range of motion, decreased strength in the upper extremity.  Currently the arm is not swollen all the time, but it aches.  The patient says it is slowly getting better,  and previously it really hurt when she got the flu shot.  On physical examination, there is decreased extension and decreased range of motion of the left upper extremity between 90 and 180 degrees.  Reporting physicians assessment:  Neuritis or tendonitis, adverse reaction to flu vaccine.   Treatment included two physical therapy  sessions, Motrin as needed.  No laboratory or diagnostics were performed.  The tendonitis was limited to the left shoulder. The patient's condition was deemed to be not work related and she requested to continue her full duty.  The physician will see her again in 7 to 14 days.  On 04/Jan/2006 the patient's work place spoke with the patient.  She will be following up with her own physician and has scheduled own PT as this is not a work related issue.  The patient cancelled her appointment with the reporting physician which was scheduled for 17/Jan/2006. Follow-up information received on 23/Mar/2006.  The case was reviewed and no additional information was available.  Follow-up information received on 20/Jun/2006 from a health care professional.  The reporter contacted the patient who stated that she experiences severe pain with certain arm movements several times per week.  When the left arm is elevated to shoulder height, she has pain at the injection site (4-5/10 on pain scale).  When she lowers the arm, the pain dissipates.  She still notices the left sided weakness, but has adapted to use both hands for a surer grip.  Per the reporter, she had not had any further evaluation or treatment related to this incident.  Follow-up information received on 24/Jul/2006 from a health care professional.  The patient had received physical therapy treatments.  Per the reporter, the pain in the left arm continues.  At the time of this report, the patient had not been evaluated by a neurologist or private physician although she plans to seek advice from primary care physician.				Y					N	11/10/2005	11/10/2005	0		OTH	PVT			The patient had no preexisting condition, is on no other medications and had no illnesses at the time of vaccination.  Follow-up information received on 22/Feb/2006:  Previous history of variety of conditions, fractures, dentures, trouble breathing, pleurisy, mitral valve prolapse, occasional irregular rhythm of the heart, urinary tract symptoms.  Last tetanus booster four years ago.  Back problem four years ago which cane under workers comp.		200600071	1						1	Asthenia; Injection site nodule; Injection site pain; Injection site reaction; Neuritis; Tendonitis	DT~BSI~~UNK~~~DT ADSORBED (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~01794A~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266970	11/15/2006	MI	28.0	27		F	03/22/2006	A initial report received on 20/Jan/2006 from a health care professional. A female patient (date of birth not reported) had received an administration (route not reported) of DIPHYTHERIA AND TETANUS TOXOIDS (lot number not reported), in the left arm and an administration (route not reported) of FLUZONE SV '2005-'2006 USP (lot number not reported), in the right arm on 09/Jan/2006. At an unspecified time later, the patient developed a baseball size lump to the left arm at the injection site that was hot to touch and red. Patient was unable to bend the elbow on the left arm. She also developed a fever and flu-like symptoms that lasted four days. At the time of this report, the arm had a one and a half centimeter hard, red area and the patient had not fully covered. Follow-up information received on 20/Mar/2006. Per reported, the patient last had tetanus/diptheria vaccination  ten years ago. Patient has no pre-existing allergies or medical conditions and denies being on any concomitant medication  or having any illnesses at the time of vaccination. The patient received the intramuscular injection of Decavac, lot number 01703CA (expiry date 11/Jul/2007) in the left arm, the intramuscular injection of Fluzone, lot number U1935AA (expiry date 30/Jun/2006) in the right arm, the intramuscular injection of the second dose of Hepatitis B Vaccine, lot number 0336R, (site not reported) and the subcutaneous injection of MMR, lot number 0295R (site not reported) on 09/Jan/2006 at 7 AM. It was also reported the patient received the intramuscular injection of the first dose of Hepatitis B Vaccine, lot number 0336R (date received not reported) within four weeks prior the vaccines received on 09/Jan/2006. The patient's fever began at approximately 7:30-8:00 PM on 09/Jan/2006 along with arm soreness. The next morning the patient's arm was very sore and progressively got more painful with redness and swelling. By evening she could hardly lift her arm or grip the steering wheel. It swelled to the size of softball which could actually be seen through the patient's clothing. The arm felt very warm and tender with touch. Also, very painful to lift or move. Almost had a bullseye appearance. Fever of 101 began approximately eight hours after injection and continued for 24 hours. On 19/Jan/2006 when this report was made there was still a 1 1/2 diameter raided hard bump that appears to be sunburned. The patient was seen by the physician on 20/Jan/2006. No diagnostic tests or laboratory data was performed. Per reporter, the patient recovered. No further information expected.				Y					Y	01/09/2006	01/09/2006	0		PVT	PVT			Per the reporter, the patient has no illnesses at the time of the vaccinations but it was unknown if she had any pre-existing medical conditions or was using any other medications. Follow-up information received on 20/Mar/2006-Per reporter, the patient last had tetanus/diptheria vaccination ten years ago. Patient has no pre-existing allergies or medical conditions and denies being on any concomitant medication or having any illness at the time of vaccination.		200600145	1						1	Erythema; Feeling hot; Influenza like illness; Injection site inflammation; Injection site reaction; Joint range of motion decreased; Pain; Pyrexia; Swelling	DT~SANOFI PASTEUR~U1703C~UNK~IM~LA~DT ADSORBED (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1935A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0336R~UNK~IM~~HEP B (FOREIGN)~1|MMR~MERCK & CO. INC.~0295R~UNK~SC~~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA	Emergency room visit	Influenza
0266971	11/15/2006	MI				M	03/03/2006	Initial report received from a Licensed Practical Nurse on 21/Feb/2006.  A male patient, 26-28 years old with no prior egg allergies developed gastroenteritis signs and symptoms after eating eggs approximately two months after receiving Fluzone (lot number unknown) in the the deltoid, administered either in October or November 2006. The patient has not received the flu shot prior. It is not known if the patient had any illness at the time of vaccination. Per the reporter there is no further information available as this event was mentioned to her months ago and she can't remember the patient's name. Recovery status is unknown.									U					UNK	UNK			No prior egg allergies. Medical conditions and concomitant medications are unknown.		200600424	1						1	Gastrointestinal disorder	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266972	11/15/2006	CA	58.0	58		F	05/05/2006	Initial report received on 24/Feb/2006 from the patient. A 58 year old female patient with a history of asthma and allergies to sulfa drugs, Penicillin, and currently taking synthroid, Theophylline and Advair, had received an intra-muscular injection of a INFLUENZA VACCINE (manufacture and lot number not reported) in the left arm, on an unspecified day in October 2005. Approximately one week later, she developed small raised bumps on her left elbow, and one month later, on both elbows and both knees. In January 2006 the bumps spread to her groin and she was seen by a dermatologist on 26/Jan/2006. She was diagnosed with Psoriasis. No other information was provided regarding the dermatology visit. Follow-up information received on 01/May/2006 from a health care provider. The product administered was Fluzone SV 2005-2006, lot number U182AA, administered on 03/Oct/2005. The patient had received annual flu vaccinations. She has received no other vaccinations within four weeks of the 03/Oct/2005 vaccination. At the time of vaccination, she had chronic asthma and allergic rhinitis. She also had a history of Hashimoto's hypothyroidism which was stable. Other medications included Claritin, albuterol and Intal. At the time of this report, the patient had not recovered.				Y					N	10/03/2005				UNK	UNK	Claritin, Intal, Albuterol		The patient had no illnesses at the time of the vaccination. She has a history of allergies to Sulfa drugs and Penicillin of which she gets hives when she takes these. She also has a history of asthma and Hashimoto's hypothyroid.		200600474	1						1	Psoriasis; Skin irritation	FLU3~SANOFI PASTEUR~U1828A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266973	11/15/2006	OH	0.88	0	.9	M	05/19/2006	Initial report was received from a consumer and a physician on 24/Apr/2006 and assessed as non-serious listed. Follow-up report was received on 17/May/2006 from a physician and the case is now considered non-serious, unlisted. A mother reported that her 15-month old  male child developed hives 6 hours after receiving the injection of Fluzone (dose two), lot number U1854AA in the left leg on 08/Nov/2005. The mother reported that the hives were large (half dollar size) on her son's torso, arms and legs. Per mom there was no fever or difficulty breathing.  The patient was seen by and allergist, date not reported. Symptoms resolved with p.o. Benadryl. Allergy testing confirmed the patient had no egg allergies. From information received on 17/May/2006 from the patient's primary care physician, the patient had a viral illness at the time of vaccination and the adverse event was reported as a croup like viral illness. The patient recovered. No further information expected. New version created on 19/May/2006 to document in the narrative that the latest received date for version 2 was 17/May/2006.				Y					Y	11/08/2005	11/08/2005	0	Allergy testing was negative for egg allergy.	UNK	UNK			The patient had no illness at the time of vaccination. He had no past medical history and was on no other medications. Follow-up received on 17/May/2006-It was previously reported the patient had no illness at the time of vaccination, however the patient's allergist reported the patient had a viral illness at the time of vaccination.		200600919	1						1	Croup infectious; Urticaria	FLU3~SANOFI PASTEUR~U1854A~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266975	11/15/2006	NY	1.87	1	.9	M	12/15/2005	Initial report received from nurse on 20/Sep/2005. A 22 month old male child immediately developed hives at the injection site, and an hour later had generalized hives after receiving the intramuscular injection of Fluzone (Preservative Free), lot number U1743JA in the left thigh on 17/Sep/2005. The patient received the flu vaccine last year with no adverse event. The generalized hives lasted for three days. The patient also had signs and symptoms of a cold with congestion, and acted like their throat was sore. There was no wheezing or respiratory distress. As per reported the signs and symptoms of the sore throat were still persisting at the time of this report. Follow up information received 01/Dec/2005. The vaccination was administered on 17/Sep 2005 at 11:00. There was no illness at the time of vaccination. At the time of this report, the patient had recovered.									Y	09/17/2005	09/17/2005	0		PVT	PVT	Vitamins		The patient has a history of eczema as an infant. At the time of vaccination he was on vitamins and had no illness. The patient did not receive any other vaccination within four weeks prior receiving Fluzone on 17/Sep/2005.		200501858	1						1	Feeling cold; Nasal congestion; Pharyngolaryngeal pain; Urticaria	FLU3~SANOFI PASTEUR~U1743JA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266976	11/15/2006	NC	19.0	19		F	12/19/2005	Initial report of a cluster of five cases received from a health care professional on 26/Sep/2005. It was reported that three employees complained of pain and swelling at the injection site. One employee had redness at the injection site and two other employees complained of pain and swelling and had an egg shaped lump at the injection site (and one of these reported feeling flushed without fever). All reported the area was warm to touch. Symptoms for all patients except one had resolved by 26 September 2005. All patients had received the flu shot in the past with no reactions. This case involves a female patient (age not reported) who developed a knot and soreness at the injection site after receiving the intramuscular injectionof Fluzone, lot number U177AA in the deltoid on 21/Sep/2005. Onset date of symptoms and treatment received was not reported. As per reporter the symptoms had resolved by 26/Sep/2005 and patient recovered. Follow up information received on 02/Dec/2005. It was reported that the patient was 19year old at the time of the events. Further information is not expected. Same reporter in cases 2005-01922, 2005-01924, 2005-01927.									Y	09/21/2005				PVT	UNK			It is unknown if the patient had any pre-existing conditions, was on medications or had any illness at the time of vaccination. The patient has received previous flu vaccinations with no reactions. Product trade name, dates of administration not reported.		200501925	1						1	Feeling hot; Injection site inflammation; Injection site mass; Injection site pain; Myalgia	FLU3~SANOFI PASTEUR~U1777AA~UNK~IM~AR~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266978	11/15/2006	NY	0.75	0	.8	F	11/28/2005	Initial report received from a registered nurse on 26/Oct/2005. A nine month old female infant developed a red flat rash on her stomach that spread to both upper and lower extremities to below the elbow and knee, three to four hours after receiving the intramuscular injection of Fluzone, lot number U1743HA in the thigh on 14/Oct/2005. As per reporter the mom stated the rash lasted 24 hours and then disappeared. Mom denied fever or pruritis. Patient recovered. Follow up information received from a health care provider on 23/Nov/2005. The patient was not seen by a physician, and the patient did not require treatment. The rash was gone within 24 hours. Further information is not expected.									Y	10/14/2005	10/14/2005	0		PVT	PVT			The patient has no known allergies or pre-existing medication conditions. She had no illness at the time of vaccination and was not on medications. No reactions to previous immunizations and did not receive any vaccinations within four weeks prior receiving Fluzone on 14/Oct/2005.		200502223	1						1	Rash	FLU3~SANOFI PASTEUR~U1743HA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266980	11/15/2006	IL	5.0	4		F	02/02/2006	Initial report received on 22/Nov/2005 from a health care provider. A 4 year old female patient, with a medical history of allergies to penicillin and sulfa, received an intramuscular, left thigh injection of Fluzone No Preservative 2005-2006, lot number U1802EA, on 05/Nov/2005. On 21/Nov/2005, the patient developed generalized hives and was treated with Benadryl without effect. She was diagnosed by her physician with Erythema Multiforme. Her strep test was negative. The patient had no illness at the time of vaccination and denied other medications. At the time of this report, the patient had not recovered. Follow-up information received on 30/Jan/2006 from a health care professional. Per the reporter, the mother called the facility on 23/Nov/2005 and indicated the patient was diagnoses by an allergist with the hives and it was felt that the hives were secondary to a random even and not the Fluzone vaccination. The patient was started on steroids and the rash was much better that day. The patient was seen by her physician on 23/Jan/2006 and she had completely recovered from all the events. No further information is expected.				Y					Y	11/05/2005	11/21/2005	16		PVT	PVT			The patient has an allergy to penicillin and sulfa.		200502538	1						1	Erythema multiforme; Rash; Urticaria	FLU3~SANOFI PASTEUR~U1802FA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266981	11/15/2006	ME	1.33	1	.3	M	03/20/2006	Initial report received on 15/Feb/2oo6 from a health care professional. A 17 month old had received an administration (route and site not reported) of FLUZONE SV, (lot number not reported) on an unspecified day in 2006. The next day, the patient developed a low grade fever and mild vomiting. No other information was provided. At the time of this report the patient had recovered from these events. Follow up information received on 17/Mar/2006 from a health care provider. The date of vaccination was 12/Jan/2006, and the adverse event onset date was 13/Jan/2006. The lot number for Fluzone is provided as U1765FA, and the vaccination was administered intramuscularly. Per the reporter, the patient had a second dose of flu vaccine on 15/Feb/2006 without any problems, and the physician felt the symptoms were due to a virus (not the vaccine). Adverse events have been amended to reflect this new information.									Y	01/12/2006	01/13/2006	1		PVT	UNK			The patient had no illness at the time of vaccination and had a history of a displaced left kidney and right ventricular hypertrophy by EKG.		200600363	1						1	Pyrexia; Viral infection; Vomiting	FLU3~SANOFI PASTEUR~U1765F~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266982	11/15/2006	PA	62.0	61		F	01/24/2006	Initial report received on 07 Oct 2005 from a patient. A 61 year old female patient with a medical history of atrial fibrillation, sino-ventricular tachycardia, osteoporosis, vertigo, ankylosing spondylitis, fibromyalgia and asthma developed chills, facial flushing, hot feeling on face, indigestion and heartburn 4 hours following the influenza vaccine (FLUZONE SV '2005-'2006), lot no: U1846AA, administration in the left arm on 06 Oct 2005. She had also experienced pounding headache, neck pain and generalized aches 8 hours following the above vaccination, among them only aches were persisting at the time of the report. It was reported that, she is taking yearly vaccination with Fluzone and was concomitantly taking treatment of Tiazac, proventil, propafenone, avista, prevacid, Claritin and xanax since an unspecified time. The patient was not recovered at the time of the report. Follow up information received on 23/Jan/2006 from a health care provider. The provider has no knowledge of the incident. Additional information is not expected.									N	10/06/2005	10/06/2005	0		PUB	UNK	Propafenone, Tiazac, Proventil, Avista, Prevacid,  Claritin, Xanax		Yearly vaccination with Fluzone Atrial fibrillation, sino-ventricular tachycardia, osteoporosis, vertigo, ankylosing spondylitis, fibromyalgia and asthma.		200502043	1						1	Chills; Dyspepsia; Headache; Hot flush; Neck pain; Pain	FLU3~SANOFI PASTEUR~U1846AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266983	11/15/2006	TX	66.0			F	11/18/2005	Initial report received from a consumer on 13/Oct/2005. A 66 year old female patient reported that approximately three years ago she developed local pinkness and warmth at the injection site which went down to the wrist area, 24 hours after receiving the injection of Fluzone. Lot number, route and site of administration not known by the patient. The patient reported symptoms lasted two to three days. She was diagnosed by a physician as having a thimerosal allergy. The patient recovered.									Y					PVT	UNK			Patient's medical history was reported as unknown other than having an allergy to thimersal.		200502100	1						1	Erythema; Feeling hot; Injection site inflammation	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266984	11/15/2006	VA	11.0	11		F	11/17/2005	Initial report received from a consumer, the mother of a patient on 15/Oct/2005. The mother reported that her 11 year old daughter developed itchy red raised spots on the front and back of her torso and neck two days after receiving the injection of Fluzone (lot number not reported) in the deltoid on 11/Oct/2005. The spots were not on the patient's face or extremities. She had no fever and no other symptoms. The physician prescribed Benadryl. The patient also had just started on a cream for a patch of eczema on 11/Oct/2005. At the time of this report the patient had not recovered.				Y					N	10/11/2005	10/13/2005	2		MIL	PVT	Zyrtec, Singular, Mometasone		Mother of the patient denies her daughter received any vaccinations within 4 weeks prior receiving Fluzone on 10/Nov/2005. Denies any illness at the time of vaccination other than and eczema patch. The patient is allergic to horses, feathers, cats, molds and has asthma and eczema. She is on Zyrtec, Singular, Mometasone ointment.		200502108	1						1	Rash pruritic	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266985	11/15/2006	PA	40.0	40		F	01/24/2006	Initial report received from a consumer on 20/Oct/2005. A 40 year old female patient complained of her skin being so sensitive, chills, pounding behind eyes, aches all over, diarrhea frequently, bones ache, and flank pain over her kidneys after receiving the intramuscular injection of Fluzone, lot number U1792AA in the right deltoid on 19/Oct/2005 at 12:30 PM. It was reported the diarrhea, which was liquid in consistency started on the 19/Oct/2005 at 4:30 PM, four hours post immunization, and was still present at the time of this report on 20/Oct/2005 at 10:30 AM. Latency of other symptoms, treatment and recovery status not reported. Follow up information received on 24/Jan/2006 from a health care provider. Per the reporter, the patient did not follow up with them. He went to his own physician. Illness at the time of vaccination, other medication and pre-existing medical conditions were all unknown. Additional information is not expected.									U	10/19/2005				UNK	UNK					200502152	1						1	Chills; Diarrhoea; Flank pain; Headache; Myalgia; Skin irritation	FLU3~SANOFI PASTEUR~01792AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266986	11/15/2006	CT	84.0	83		F	12/21/2005	An 83 year old female patient had received an injection (Route and site not reported) of FLUZONE SV '2005-'2006 USP (lot number not reported), on 19/Oct/2005. Per the reported, one to two days later the patient complained of chills. Then 23/Oct/2005 her behavior changed drastically with mental changes and a change in her disposition. The patient suddenly became illogical and had memory loss along with anxiety and paranoia. The reporter described this with an example of the patient asking Where is my mother in the house? The patient did not recognize people close to her. The patient was not evaluated by a physician. The reporter states that the patient has had a similar reaction such as this in the past with the use of prednisone. Follow up information received on 15/Dec/2005 from the vaccine provider. Lot number for Fluzone SV 2005-2006 is provided as U1903AA. The vaccine provider is not the patients health care provider. Additional medical information cannot be provided for this patient. The patient is lost to follow up. Further information is not expected.									N	10/19/2005	10/23/2005	4		PUB	PUB			The patient denies any illnesses at the time of the vaccination. She has a pre-existing medical condition of arthritis and has no known allergies. In the past, the patient has experienced mental changes, changes in her behavior, anxiety, paranoia, memory loss an illogical thinking with the use of prednisone. She was not using any medication at the time of the vaccination. The patient had no other vaccinations within four weeks prior this vaccination.		200502235	1						1	Abnormal behaviour; Amnesia; Anxiety; Chills; Histrionic personality disorder; Mental impairment; Paranoia; Thinking abnormal	FLU3~SANOFI PASTEUR~U1903AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266987	11/15/2006	MI	54.0	53		F	03/28/2006	Initial report received on 01 Nov 2005 from a patient. A 53 year old female patient with a medical history of allergy to cats and intravenous iodine developed coughing for 15 minutes and her eyes began to feel gritty and turned blood shot red around 3:00pm following the influenza vaccine (Fluzone SV '2005-'2006) administration on 26 Oct 2005 at 11:00am. It was reported that, by 6:00pm she had a hard time seeing. Lather in the evening, she reported to have flu like symptoms with nausea and feeling weak. She was on prevacid from an unspecified time for gastroesophaeal reflux disease. She went to bed at an unspecified time and next day she was fine. Follow up information received on 27/Mar/2006 from the patient. There was no illness at the time of vaccination, and the patient was on no other medications. Additional information was not provided.									Y	10/26/2005	10/26/2006	365		OTH	PVT			Patient had Fluzone since 1995 every year. Allergy to cats and intravenous iodine. Gastroesoophageal reflux disease.		200502277	1						1	Asthenia; Cough; Eye irritation; Influenza like illness; Nausea; Ocular hyperaemia; Visual acuity reduced	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266988	11/15/2006	CA				F	12/08/2005	Initial report received on 10 Nov 2005 from a patient. A female patient of no reported age and medical history immediately developed a severe sinus infection and urinary tract infection following flu vaccine at a pharmacy about a week ago. Outcome was not reported.														UNK	UNK					200502425	1						1	Sinus congestion; Urinary tract infection	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266989	11/15/2006	NY	42.0	42		M	06/13/2006	Initial report received on 14-NOV-2005 from a health care professional. A 42-year-old male patient with patient with a medical history of moderate asthma experienced congestion of the sinus and lungs, laryngitis, and felt feverish, 24 hrs following the influenza vaccine (Fluzone SV '2005-'2006) administration in the left deltoid. Signs and symptoms were less than 2 days ago but it still persisted at the time of the report. It was also reported the patient had dark sputum and he was not recovered at the time of the report. Patient was receiving yearly vaccination with the same vaccine since an unspecified time. Follow-up information received on 12/Jun/2006 from the patient. At the time of this report, the patient had recovered.									Y	11/09/2005	11/10/2005	1		PUB	UNK	Advil, Maxair		Moderate asthma. Yearly vaccination with Fluzone.		200502439	1						1	Nasal congestion; Pulmonary congestion	FLU3~SANOFI PASTEUR~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266990	11/15/2006	AZ	50.0	50		M	12/14/2005	Initial report received on 21-NOV-2005 from a patient in USA. A 50-year-old male patient with no reported medical history but ongoing head cold or sinus infection experienced injection site pain within an hour following influenza vaccine (Fluzone SV '2005-'2006), lot no: U1865AA administration in the right deltoid. He had received the one dose of the same vaccine previously at an unspecified time. He has pain in the shoulder joint and when he sleeps with his arm over his head, after these 2 and half weeks sore, dull pain in the right shoulder. The patient was not recovered at the time of the report.									N	11/04/2005	11/04/2005	0		UNK	UNK			Ongoing head cold or sinus infection		200502531	1						1	Arthralgia	FLU3~SANOFI PASTEUR~U1865AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266991	11/15/2006	DC	41.0	41		F	12/21/2005	Initial report received on 08-DEC-2005 from a patient in USA. A 41-year-old female patient with a medical history of no known allergies, increased cholesterol and asthma woke up with pain and stiffness in her fingers and joints bilaterally, i.e. approximately 2 days after the influenza vaccine (Fluzone SV '2005-'2006), lot no.: U1804AA administration in the left deltoid on 11-Oct-2005. Also she had some pain in the inner side of her elbows. Additionally, she complained of a travelling pain in her lower back, wrist and achilles tendon area bilaterally. The laboratory tests performed at an unspecified time revealed mycoplasma pneumonia elevated. Pain continues to persist. Patient also stated that her left middle finger appears swollen at the joint at the time of the report. Outcome was not reported. Of note that, the patient was taking Lipitor and Zyrtec occasionally.										10/11/2005	10/13/2005	2	Mycoplasma pneumonia elevated	PUB	PUB	Lipitor, Zyrtec		No known allergies, increased cholesterol and asthma. Receiving Fluzone annually.		200502737	1						1	Arthralgia; Joint stiffness; Laboratory test abnormal; Oedema peripheral	FLU3~SANOFI PASTEUR~U1804AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0264956	11/16/2006		1.03	1	.0	F	11/14/2006	Information has been received from a nurse concerning a 12 month old female who on 17-OCT-2006 was accidentally vaccinated with a 0.5 mL sc dose of varicella-zoster virus vaccine live instead of a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (MSD). The patient was asymptomatic at the time of the report. Additional information has been received from a health professional who reported that the patient was fine and had no reported adverse experiences. The reporter believed that the error occurred likely due to the fact that both vaccines were stored in the freezer and that the vials looked very similar. She noted that although the vial caps were color-coded and different for each vaccine, this was not readily or easily seen upon first glance. She added that it would be very helpful if the actual boxes containing the vaccines were different colors or somehow very distinct from each other. She felt that in general, the vaccine boxes were all very similar. The patient's sister was also inadvertently vaccinated with varicella-zoster virus vaccine live (WAES 0610USA10818). This is in follow-up to report (s) previously submitted on 11/14/2006. Information has been received from a nurse concerning a 12-month-old female who on 17-OCT-2006 was accidentally vaccinated with a 0.5 mL SC dose of ZOSTAVAX (Merck) (lot # 652936/0981F) instead of a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Merck upgrade process) (MSD). The patient was asymptomatic at the time of the report. Additional information has been received from a health professional who reported that the patient was fine and had no reported adverse experiences and no chickenpox rash was noted. The reporter believed that the error occurred likely due to the fact that both vaccines were stored in the freezer and that the vials looked very similar. She noted that although that the vial caps were color-coded and different for each vaccine, this was not readily or easily seen upon first glance. She added that it would be very helpful if the actual boxes containing the vaccines were different colors or somehow very distinct from each other. She felt that in general, the vaccines boxes were all very similar. The patient's sister was also inadvertently vaccinated with ZOSTAVAX vaccine (Merck) (WAES # 0610USA10818).									U	10/17/2006	10/17/2006	0	Unknown	OTH	OTH	Unknown		Unknown	medication error~Zoster (Zostavax)~~4.00~Sibling	WAES0610USA10819	1						2	Medication error; Medication error	FLU3~SANOFI PASTEUR~U2174GA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0144F~1~IM~LL~HEP A (VAQTA)~1|HIBV~MERCK & CO. INC.~0494P~3~IM~LL~HIB (PEDVAXHIB)~1|VARZOS~MERCK & CO. INC.~0981F~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1|VARZOS~MERCK & CO. INC.~0981F~UNK~SC~UN~ZOSTER LIVE (ZOSTAVAX)~2	USA		Influenza
0266869	11/16/2006	IL	68.0	68		F	11/15/2006	After 1st day, reactions rash, itching on face, arms and legs since Oct 20th 2006. Pt went to see doctor on 11/08/06 but talked to MD on 10/20/06 and got Prednisone on 10/27/06.				Y					Y	10/19/2006	10/20/2006	1	NONE	OTH	OTH		NONE				1						1	Rash pruritic	FLU3~SANOFI PASTEUR~U2257AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0266887	11/16/2006	MT		47		F	11/09/2006	11/03/2006 at 4am clt developed sx of Nausea, Vomiting and diarrhea. Clt stated she felt very tired with episodes of chills and sweating and sore upper abdomen. No fever. Client states she had GI problems and often experiences GI side effects with medication. 11/09/06 TC to client states n/v stopped on 11/03, but continued to have extreme hotness and sweating thru 11/4. Client was fine on 11/05/06.									Y	11/02/2006	11/03/2006	1		PUB	PVT	Prilosec				MT0606	1						1	Abdominal pain; Chills; Diarrhoea; Fatigue; Feeling hot; Hyperhidrosis; Nausea; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71034~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB050AA~1~IM~RA~HEP A + HEP B (TWINRIX)~1|TD~MASS. PUB HLTH BIOL LAB~TD155~UNK~IM~LA~TD ADSORBED (TDVAX)~1|YF~SANOFI PASTEUR~UE888AA~1~SC~LA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0266889	11/16/2006	MI	14.0	14		F	11/16/2006	Pt received injections 10/25/06. Flu and HPV in one thigh. Tdap and Menactra in other thigh unk which thigh each given. Pt then went to allergist and received allergy injection in each arm. Admitted 10/26/06 for fever 103, dehydration and muscle cramping, sent home 10/27/06. DC DX: allergic reaction.  2 day history of fever. On same day as immunizations she received routine allergy shots. Immunizations received in thighs and allergy injections in arms. Complained of arms puffed and welted evening prior to admission, became painful. Also blotchiness on legs. Complained of pain in legs. Headache since immunizations, myalgias and arthralgias especially to shoulder area. Neck pain, prickly sensaton in feet. Previous immunization reacion 3 weeks ago with pain and symptomatic problems.  PMH: environmental allergens. Eczema. Roavirus at age 2  months. PE: Extremities, there is injection site visible. No rash, erythema or exudate noted around the injection sites. No other rashes.					Y				Y	10/25/2006	10/26/2006	1	Labs: Glucose 118, CO2 21, C-reactive protein 1.8.	PVT	PVT	Nasocort, Zyrtec, Allergy injections.		Allergic Rhinitis.  PMH: environmental allergens. Eczema. Roavirus at age 2  months.			1						1	Dehydration; Hypersensitivity; Muscle spasms; Pyrexia	FLU3~SANOFI PASTEUR~U2256AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0955F~1~IM~UN~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U1948AA~1~IM~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B012AA~1~IM~UN~TDAP (BOOSTRIX)~1	USA	Hospitalisation	Influenza
0266892	11/16/2006	MI	43.0	43		F	11/13/2006	Several days later, fever, chills, headache, body aches.									U	10/16/2006	10/19/2006	3		PUB	PVT		NONE	NONE			1						1	Chills; Headache; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA206AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0266893	11/16/2006	NY	42.0	42		M	11/16/2006	10/31/06 had flu vacc, 11/02/06 began flu symptoms, feverish, chills, headache, achy, productive cough, runny nose, sore throat, will observe for now.				Y					N	10/31/2006	11/02/2006	2	Chest X ray	PUB	UNK		NONE				1						1	Chills; Cough; Headache; Influenza like illness; Pain; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~2F600911~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0266894	11/16/2006	AZ		58		F	11/14/2006	Swelling, redness and pain over right deltoid, developed by next AM fever to 102.6 CXR showed pneumonia on 11/09/06.				Y					Y	11/07/2006	11/08/2006	1	CXR LLC Pneumonia	PUB	PUB		NONE	RSD right arm.			1						1	Injection site erythema; Injection site oedema; Injection site pain; Pneumonia; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~74641~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1049P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0266895	11/16/2006	MI	39.0	39		F	11/10/2006	Could not sleep, sweating, hurt all over, nausea, headache.									Y	10/17/2006	10/18/2006	1		PVT	UNK						1						1	Headache; Hyperhidrosis; Insomnia; Nausea; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA206AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0266896	11/16/2006	KS	0.02	0	.0	M	11/13/2006	Pt received vaccination around 9am returned to vaccination room at 10:30 with complaints of itching, difficulty breathing, diaphoresis, and dizziness. Fire and medic called to triage pt on site. Pt walked away after treatment.									Y	11/09/2006	11/09/2006	0	None	PUB	PUB	None	None	None			1						1	Dizziness; Dyspnoea; Hyperhidrosis; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71034~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0266897	11/16/2006	IL	70.0	69		F	11/16/2006	3 days after getting injections noticed dry cough, felt congested, no temp, no redness, no swelling at either site.									U	11/09/2006	11/12/2006	3		PUB	UNK		None	high blood pressure, blood sugar increase			1						1	Cough; Nasal congestion	FLU3~SANOFI PASTEUR~U2241AA~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0620F~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266898	11/16/2006	VA	62.0	62		F	11/12/2006	Left bicep area tightened up within 20 minutes of shot; then the left upper arm ached. An 8 on a 1-10 pain scale. Like the bone has been bruised. The area near the bicep actually turned black and blue. By Oct. 6 the aching stopped and the bruising gradually disappeared in 10 days.									Y	10/04/2006	10/04/2006	0	None	OTH	UNK		Left frozen shoulder	inflammation of rotator cuff-left			1						1	Contusion; Myalgia	FLUX~UNKNOWN MANUFACTURER~1412~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~1037P~1~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0266899	11/16/2006	CA	64.0	63		F	11/13/2006	Could not breathe without coughing 3 hours after vaccination.									Y	11/02/2006	11/02/2006	0		PVT	UNK		None	None			1						1	Cough; Dyspnoea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0266900	11/16/2006	CA	72.0	71		F	11/13/2006	Left arm pain at site of injection of flu shot began 3 days after injection and has continued to date. Some relief with Ibuprofen. Pain radiating up and down Left arm to shoulder, elbow, armpit, left chest.									N	09/18/2006	10/01/2006	13		PVT	PVT	Actonel	mild Vertigo				1						1	Injection site pain; Pain	FLU3~SANOFI PASTEUR~42240AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266901	11/16/2006	WA	77.0	76		F	11/16/2006	congestion in the 24hours after injection and swelling entire upper Right arm including right shoulder. With inflammation into right axilla very painful with mobility greatly decreased.									Y	10/10/2006	10/10/2006	0		OTH	UNK		None	Molds			1						1	Inflammation; Joint range of motion decreased; Nasal congestion; Swelling	FLU3~SANOFI PASTEUR~U2186AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0391F~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266903	11/16/2006	NY	16.0	16		F	11/10/2006	Patient has seizure history. Last seizure was over 1 year ago. Had grand mal seizure 31 hours after receiving flu vaccine.									Y	11/08/2006	11/09/2006	1		PVT	PVT	Lamintol, Zetoritin	None	seizure disorder			1						1	Grand mal convulsion	FLU3~SANOFI PASTEUR~Y2244AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266906	11/16/2006	MA	74.0	74		F	11/10/2006	5x5 for one day. Right arm red, swollen, warm, painful; rates pain at 7, couldn't sleep because of pain, positive itchy. Instructed patient to apply ice; patient given Clarinex.										11/09/2006	11/10/2006	1		PVT	PUB	None					1						1	Erythema; Feeling hot; Insomnia; Pain; Pruritus; Swelling	FLU3~SANOFI PASTEUR~72006~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1040P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266907	11/16/2006	OH	65.0	64		F	11/10/2006	Vaccine given on 10-31-2006. Arm turned red and swelling within a few hours. Very painful. Temp 100F by 7 pm. Went to hospital. ER doctor confirmed a reaction. Use ice and go back to doctor. Went back to doctor on 11/01/06 was told it was cellulitis and given amoxcillan 500 mg for 7 days.				Y					Y	10/30/2006	10/30/2006	0	Just seen by ER doctor.	UNK	UNK		None	None			1						1	Cellulitis; Erythema; Injection site pain; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0266908	11/16/2006	OH	3.0	3		M	11/13/2006	Flu vaccine injected on 11/11/06. Redness at site noted 20-24 hours after injection. Applied warm compress. Increased in size over next 24 hours - scheduled appt with Pediatrician. 10 cm x 8.5 cm redness, warm, positive induration. Rx Duricef. Also seeing allergist.									N	11/11/2006	11/12/2006	1		PVT	PVT	NONE	NONE	Peanuts			1						1	Injection site erythema; Injection site induration; Injection site warmth	FLU3~SANOFI PASTEUR~U2169MA~5~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266909	11/16/2006	NC	32.0	31		F	11/28/2005	It was reported that three employees complained of pain and swelling at the injection site. One employee had redness at the injection site and two other employees complained of pain and swelling and had an egg shaped lump at the injection site (and one of these reported feeling flushed without fever). All reported the area was warm to the touch. Symptoms for all patients except one had resolved by 26-SEP-2005. All patients had received the flu shot in the past with no reactions. This case involves a female patient (age not reported) who developed redness and irritation over the entire top of her arm at the injection site after receiving the intramuscular injection of FLuzone in the deltoid on 21-SEP-2005. Onset date of symptoms and treatment received was not reported. As per reporter the symptoms had resolved by 26-SEP-2005 and patient recovered. Same reporter in cases 2005-01923, 2005-01924, 2005-01925, 2005-01926, 2005-01927. Follow-up information received from a health care provider on 23-NOV-2005. The vaccine administrator's name, patient's date of birth and age are provided. The patient's age is 31 years. No additional information is provided. Further information is not expected.									Y	09/21/2005				PVT	UNK			It is unknown if the patient had any pre-existing conditions, was on medications or had any illness at the time of vaccination. The patient has received previous flu vaccinations with no reactions. Product trade name, dates of administration not reported.		200501922	1						1	Injection site erythema; Injection site reaction	FLU3~SANOFI PASTEUR~U12777AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266910	11/16/2006	NC	30.0	30		M	12/19/2005	Initial report of a cluster of six cases with the same lot number was received from a health care professional on the 26/Sep/2005. It was reported that three employees complained of pain and swelling at the injection site. One employee had redness at the injection site and two other employees complained of pain and swelling and had an egg shaped lump at the injection site (and one of these reported feeling flushed without fever). All reported the area was warm to touch.  Symptoms for all patient except one had resolved except for one by 26 September 2005. All patients had received the flu shot in the past with no reactions. This case involves a male patient ( age not reported) developed an oval shaped hard area right below injection site, his face was flushed and his cheeks were red after receiving the intramuscular injection of Fluzone in the deltoid on 21 Sep 2005.  The nurse checked the patient's temperature as he felt feverish but he did not have a fever. Onset date of symptoms and treatment received was not reported. As per reporter the symptoms had resolved by 26 Sep 2005 and patient recovered. Same reported cases 2005-01922, 2005-01924, 2005-01925, 2005-01926, 2005-0192 Follow-up information received on 28 Nov 2005. The patient name and date of birth are clarified. The patient was 30 years old at time of the event. Further information is not expected.									Y	09/21/2005				PVT	UNK			It is unknown if the patient had any pre-existing conditions, was on medications or had any illnesses at the time of vaccination. The patient has received previous flu vaccinations with no reactions.  Product trade name, dates of administration not reported.		200501923	1						1	Feeling hot; Flushing; Injection site reaction	FLU3~SANOFI PASTEUR~01777AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266993	11/16/2006	TX	59.0	58		F		2 hours after getting injection patient started having flu like symptoms. Could hardly lift arm. Patient took some Tylenol and has been feeling better.									Y	11/13/2006	11/13/2006	0	None	PVT	PVT	Advair, Prednisone synthoid, Ambien, Periactin	None	Aspirin, Penicillin, Kelfex tequin			1						1	Influenza like illness; Joint range of motion decreased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F600911~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0266995	11/16/2006	TN	36.0	36		F	11/08/2006	Vesicular lesion 1.5cm at injection site. 7 other vesicles resembling varicella lesions on arms, chest. Follow-up Information sent 16 November, 2006: I am a family doc. I had a patient with an unusual reaction to killed flu vaccine. I am attaching photos. The first two (dated 2004 on photo) were taken Nov 8, 2006, 1 week after vaccination. The lesions appear vesicular and are on both arms, the largest being at the injection site. The second set of three photos were taken Nov 14th, 2006, 2 weeks after vaccination. The lesions at the injection site was 2cm across, appeared to have central clearing with an indurated margin. The lesions are not pruritic. I will fax the VAERS sheet and mail the originals. Thanks for your help and insight.									Y	10/31/2006	11/01/2006	1	Photos	OTH	PVT	LOESTRIN 1/20 (BCPs)	None	Seafood allergy			1						1	Blister; Injection site induration; Skin ulcer	FLU3~SANOFI PASTEUR~U2243AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266996	11/16/2006	AL	6.0	6		F	11/16/2006	Administered wrong dose of flu vaccine to patient. Administered 0.5cc IM of Flulaval-Influenza vaccine for Adults to a 6yr old child.  This patient did not have an adverse event the patient was given the wrong dose of medicine.										11/16/2006				PVT	OTH	Trileptal, Keppra		Epilepsy			1						1	Incorrect dose administered; Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F600411~1~IM~RL~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0267009	11/16/2006	MA	14.0	14		M	11/16/2006	Received flu shot on 11/10/06 in the morning, was fine all day, at approximately 345pm developed bad headache, sweating, vomiting and chills. no neck pain or stiffness. took tylenol. did not go to the emergency room.									Y	11/10/2006	11/10/2006	0		UNK	UNK	flovent albuterol	none	allergy to amoxicillin hx reactive airway disease			1						1	Chills; Headache; Hyperhidrosis; Vomiting	FLU3~SANOFI PASTEUR~U2253AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267010	11/16/2006	MN	37.0	37		F	11/16/2006	11-15-06 noticed numbness, swelling, pain, and blisters roof of mouth behind two front teeth. Stomach ache evening of 11-13-06. Will go to see a doctor if symptoms do not resolve.										11/13/2006	11/15/2006	2		UNK	UNK	vitamins	no	none			1						1	Abdominal pain upper; Hypoaesthesia; Oral mucosal blistering; Pain; Swelling	FLUN3~MEDIMMUNE VACCINES, INC.~500439P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0267011	11/16/2006	ND	49.0	49		M	11/16/2006	Seen on 14Nov06 with c/o cold and flu sx. Following Flu Mist inoculation 3 days prior. Non-specific symptoms listed, generalized achiness. Diagnosed as Viral Syndrome (NOS) s/p Flumist 3 days prior. Motrin prn, Robitussin DM, push fluids.				Y					Y	11/10/2006	11/14/2006	4	None	MIL	MIL	Diltiazem, Cetirizine, Terbinafine, Naproxen, HCTZ, Rabeprozole Sodium,	None	Seasonal Allergies, Celery			1						1	Influenza like illness; Pain; Pharyngitis; Rhinitis; Viral infection	FLUN3~MEDIMMUNE VACCINES, INC.~500439P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0267012	11/16/2006	WI	14.0	14		M	11/16/2006	Injection given Sub Q intead of IM. Ice pack to arm immediately.  No adverse symptoms. No local irritation or inflammation.									Y	11/08/2006				UNK	UNK						1						1	Medication error	FLU3~SANOFI PASTEUR~U2242AA~1~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267013	11/16/2006	OH	23.0	23		F	11/16/2006	Received inactivated flu vaccine approx. 0830 11/15/06 was sent to outpatient tx. unit approx 1440 with c/o itching then dry cough and some dypsnea. BP 122/79, P 91, R 22 O2 sat 100%, 1444 epinephrine 0.4 given IM right deltiod, albuteral via nebulizer x3 starting at 1445, IV of 0.9%NS started , 1505 Benadryl 50mgm given IVP, 1510 Solu-medrol 125mggm given IVP at this time BP 146/71, P123, O2 sat 98%. Monitored for 3 hours and discharged to home-respiratory symptoms resolved				Y					Y	11/15/2006	11/15/2006	0	none done	UNK	UNK	Ortho Tri-Cyclen Wellbutrin 100 mgm every day	none	none			1						1	Cough; Dyspnoea; Pruritus	FLU3~SANOFI PASTEUR~U2260AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267014	11/16/2006	SC	44.0	44		F	11/16/2006	Received vaccination at hospital during annual flu shot administraion. Vaccination to Right deltoid.  Swelling and tenderness of right elbow on 11/07/2006. Increasing fatique and general joint tenderness to all joints-onset evening of 11/07/2006. Low grade fever, running nose, sore throat and general mailaise, onset 11/10/06. Fever resolution on 11/13/06. R elbow continues to be swollen and inflamed as of this report. Right arm weakness persists.									U	11/06/2006	11/07/2006	1	NP confirmed that there is no DVT or arterial occlusion to Right arm.  Objectively looks like an unexplained bursitis in right elbow joint. Causing pain and swelling. R arm weak. Unable to hold mug etc.	UNK	UNK	none	none	none			1						1	Arthralgia; Bursitis; Fatigue; Malaise; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea; Swelling; Tenderness	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0267016	11/16/2006	WA	62.0	62		F	11/16/2006	Low back pain onset same day as immunizations.   No h/o injuries or trauma. Has improved over last 2 days somewhat.  No fever, no other arthralgias or myalgias, no weakness or numbness.  Patient has had h/o of similar episodes of low back pain x 2 in her life.  Immunizations given include Td right deltoid and influenza vaccine left deltoid.				Y					U	11/07/2006	11/07/2006	0	None	UNK	UNK	aspirin, Zocor, Prilosec, Pulmicort, Flonase, Diovan, Ditropan	NONE	ECZEMA  H/O DEPRESSION  POSTMENOPAUSAL  MIGRAINES 346.10 CTS  OSTEOARTHRITIS  HTN 401.1 INCONTINENCE  GERD 530.81 ALLERIC RHINITIS 477.9 ASTHMA 493.00 HYPERLIPIDEMIA 272.4			1						1	Back pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71216~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~SANOFI PASTEUR~U1880BA~4~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0267017	11/16/2006	TX	53.0	53		F	11/16/2006	Arm was swollen, hot to the touch, welts from the elbow to the shoulder. This lasted for two days, I was very uncomfortable and I stayed in bed taking Advil and Benadryl. By the 4th day, I felt back to normal.									Y	11/07/2006	11/07/2006	0		UNK	UNK	Zelnorm	none	irritable bowel			1						1	Injection site warmth; Oedema peripheral; Urticaria	FLU3~SANOFI PASTEUR~U2272AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0320F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267018	11/16/2006	TX	5.0	5		M	11/16/2006	RT HAD 5CM SWELLING, REDNESS.									Y	11/06/2006	11/06/2006	0	NONE	UNK	UNK	NONE	IN GOOD HEALTH, TEMP NORMAL	NONE	5CM BUMP NEAR INJ. SITE~Influenza (Seasonal) (Fluzone)~6~5.80~In Patient		1						1	Erythema; Swelling	FLU3~SANOFI PASTEUR~C2243AA~6~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267019	11/16/2006	AZ	63.0	63		F	11/16/2006	Patient developed erythema (2 days post-vacine) with swelling and redness.  Main involved area was approximately baseball sized with some diffuse smaller surrounding red areas.									N	11/14/2006	11/16/2006	2	Patient reported no adverse reaction to prior vaccines.  Patient complained of a sore throat prior to vaccine.	UNK	UNK	N/A	Patient complained of sore throat.	N/A			1						1	Erythema; Swelling	FLU3~SANOFI PASTEUR~U2218AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0620F~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267020	11/16/2006	NJ	11.0	11		F	11/16/2006	Acute Bell Palsy, noon on 11/15/06. Left sided. Neuro exam normal. 12/19/06 Received medical records from reporter/provider which reveal patient in good health on day of vax.  Next visit was 11/16/06 which revealed that on 11/15 patient abruptly developed droop of left face, smiling only on right side, decreased taste on left side.  Left eye would not close tightly & could not raise left eyebrow.  Treated w/eye ointment. Final DX: Bells Palsy.				Y					U	11/01/2006	11/15/2006	14	none	UNK	UNK	none	none	asthma			1						1	Dysgeusia; Facial palsy; Ophthalmoplegia	FLU3~SANOFI PASTEUR~c2557aa~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~u2241aa~1~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0267021	11/16/2006	GA	51.0	51		F	11/16/2006	At the time of injection (11:55 a.m. Tuesday morning Nov. 14th 2006) I was healthy, just finished a 3 mile run, was well hydrated and feeling great.  After the injection I started going down hill in the evening.  Starting with a sore arm at site for injection.  Then aches and pains, followed by very sore throat and still today it is hard to swallow. Could not sleep that night due to the aches, sinus congestion, inability to breath through nose, sore throat and every joint aching as well as muscle aches that included even my gums and scalp.  The next day I had absolutely no energy, could not get up and function.  Stayed in bed all day unable to participate in daily life, and took Sudafed, Advil and throat spray. These symptoms continued through the night of the 14th through all day on the 15th and are some what subsiding but still very much present on the 16th.  The reaction was so severe I swore off ever getting another flu shot.									U	11/14/2006	11/14/2006	0		UNK	UNK	Synthroid 125 MCG	NONE, never been healthier	pre-diabetic, controlled	flu symptoms~Influenza (Seasonal) (no brand name)~~4.80~In Patient		1						1	Arthralgia; Asthenia; Dysphagia; Dyspnoea; Injection site pain; Insomnia; Myalgia; Nasal congestion; Pain; Pharyngolaryngeal pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA221AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0267022	11/16/2006	VA	53.0	53		M	11/16/2006	Pneumonia vaccine, noteworthy reaction.  Received immunization in right leg.  About 6 hours after this, developed stiffness and swelling in leg muscle from hip to knee, so severe that I literally could not bend the leg more than a few degrees.  It took 15 minutes to bend it enough to sit in an automobile, and then another 15 minutes to unbend it upon standing up.  Skin was light pink on front and inner leg, about 10 degrees warmer to touch than opposite leg, and leg had swollen about 10-15% larger than other leg, to the point the skin was stretched.  This extreme swelling and stiffness/warmth lasted 30 hours and then slowly dissipated over the following three days, with some redness and swelling remaining between knee and 8 above knee for another 3 days.  So, a little over a week altogether.				Y					Y	11/01/2006	11/01/2006	0	None, was seen by nurse two days after the immunization to document this reaction.	UNK	UNK	None	None	None			1						1	Erythema; Joint range of motion decreased; Musculoskeletal stiffness; Swelling	DTPHIB~UNKNOWN MANUFACTURER~~UNK~IM~LA~DTP + HIB (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~RL~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0267024	11/16/2006	NM	44.0	44		F	11/16/2006	Pain in my left arm, left hand tingling, painful shoulder.  Range of Motion are severly limeted.  Have recieved a shot of toradal at Doctors office.  Also took a prescription of prednazone.  A nerve damage test is scheduled for november 27th.  I feel like I am losing strenghth in my left arm and shoulder.				Y					N	10/27/2006	10/27/2006	0		UNK	UNK	synthroid, zoloft, glucophage, carafate					1						1	Asthenia; Joint range of motion decreased; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267026	11/16/2006	PA	5.0	5		M	11/16/2006	Per mom, asthma symptoms since the intranasal influenza vaccine was administered. Symptoms were intermittent but cough was fairly consistent since the vaccine was given.				Y					Y	10/12/2006	10/13/2006	1	CXR: hyperinflation good response to bronchodilators and prednisone	UNK	UNK		none	hospitalized with asthma type symptoms at age 3 years			1						1	Asthma; Condition aggravated; Cough	FLUN3~MEDIMMUNE VACCINES, INC.~.500433P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0267027	11/16/2006	MI	31.0	31		F	11/16/2006	Approximately 4 to 5 hours later, patient developed pain in joints throughout body; upper arm where vaccines were administered was red, warm (looked like blotchy rash).									N	11/14/2006	11/14/2006	0		UNK	UNK		Lupus	lupus			1						1	Arthralgia; Injection site erythema; Injection site warmth; Rash; Rash macular	FLU3~SANOFI PASTEUR~u2271AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1004y~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267028	11/16/2006	MS	64.0	64		M	11/14/2006	2 WEEKS AFTER VACCINATION PT HAD SEVERE VERTIGO SAW PMD AND GIVEN RX FOR ANTIVERT.  AS OF 11/14/06 PT STILL WITH DIZZINESS.				Y					Y	10/24/2006	11/05/2006	12		UNK	UNK		NONE VOICED			MS06016	1						1	Dizziness; Vertigo	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70279~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0267029	11/16/2006	MS	94.0	94		F	11/14/2006	2 weeks after flu vaccine, patient had severe dizziness and vertigo; Saw PMD and was given Rx for antivert.  As of 11/14/2006 patient had improved some, but still c/o some dizziness.				Y					Y	10/24/2006	11/05/2006	12		UNK	UNK		None Voiced	Unknown		MS06017	1						1	Dizziness; Vertigo	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70279~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0267033	11/16/2006	FL	18.0	18		M	11/16/2006	Developed Guillain Barre Syndrome about 1 week after receiving flu vaccine. Had strep pharyngitis about 6 weeks before onset of Guillain Barre. Experienced peripheral numbness and about 1 week prior to requiring hospitalization for weakness on 11/08/2006.  5/11/07 Received medical records from hospital which reveal patient experienced LE numbness, difficulty walking & went to ER.  Neuro consult done.  LP done was abnormal & combined w/LE areflexia, ataxia, paresis of LEs admitted 11/8/06-11/18/06 for GBS.  Tx w/plasmapheresis x 5 w/good results.  Continued to have some weakness of toes & numbness of LEs but was minimal at D/C to home w/PT.   FINAL DX: Guillain Barre syndrome, s/p plasmapheresis.			Y	Y	Y	10	Y		Y	10/27/2006	11/08/2006	12	Increased protein in CSF LABS: Chem & CBC were WNL.  CK was 342.  Serum IgG 1940, albumin 5.0. CSF revealed protein 85, glucose 54, Albumin 59.6, IgG 13.5, c/s neg.  Blood c/s neg.  MRI of L-spine was WNL.  CT of brain was WNL.  CXR was WNL.	PVT	PVT	NONE		Nodular cystic allergies.  PMH: URI approx 4 wks prior to this admit.			1						1	Asthenia; CSF test abnormal; Guillain-Barre syndrome; Hypoaesthesia	FLU3~SANOFI PASTEUR~U2175GA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0267035	11/16/2006	MI	14.0	14		F	11/16/2006	Mom said about 48 hours after shot, within 15 minutes, upper body waist broke out in very red and irritating hives. Mom gave her BENADRYL and hydrocortisone topical. Mom called Dr next day 11/16 to inform that blisters were almost completely dry. Doing better.									Y	11/13/2006	11/15/2006	2	NONE	OTH	PVT		NONE				1						1	Urticaria	FLU3~SANOFI PASTEUR~U2216AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267036	11/16/2006	TX	30.0	29		F	11/10/2006	Dizziness, cotton mouth, drowsiness. Unable to stay awake, hard to move mouth, facial muscles, tingling in face. Headache could feel inject contents move up and through arm in a rush about 5 min after given. Next day-headache, still dizziness with fast motion. Hard to focus attention.									Y	11/09/2006	11/09/2006	0		OTH	PVT			Sulfa drugs			1						1	Dizziness; Dry mouth; Headache; Paraesthesia; Somnolence	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72002~5~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267038	11/16/2006	TX	33.0	32		F	11/11/2006	Dizzy, disoriented, roaring in head, unable to stay awake, lowered blood pressure. Lasted approximately 15 hours. Extreme dry mouth.				Y					Y	11/07/2006	11/07/2006	0	NONE	OTH	PVT	Estrogen, Progesterone		Sulfa drugs			1						1	Blood pressure decreased; Disorientation; Dizziness; Dry mouth; Headache; Somnolence	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72002~5~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0267039	11/16/2006	TX	20.0	19		F	11/11/2006	Dizziness, cotton mouth, headache, could not focus, swelling on arm the size of a quarter for about 3 days.									Y	11/07/2006	11/07/2006	0	NONE	OTH	PVT	Fluticasine, Singular, Allegra-D, Yasmin					1						1	Disturbance in attention; Dizziness; Dry mouth; Headache; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72002~3~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267040	11/16/2006	GA	66.0	66		F	11/16/2006	Client reported today by phone - on 11/8/06 left arm red, warm to touch and raised area blotches. Seen at her Dr office the afternoon on 11/8/06 for stomach problems, reflux and COPD did but doctor see the area. reported to health dept 11/16/06 at 3:30 pm to nurse.				Y					Y	11/07/2006	11/08/2006	1		PUB	UNK	Z-pack, Prilosec, Zyrtec	Reflux disease, stomach problems				1						1	Erythema; Feeling hot; Rash maculo-papular	FLU3~SANOFI PASTEUR~U2248AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0601F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0267041	11/16/2006	NY	36.0	36		F	11/16/2006	None Stated.  11/30/06 Received medical records from hospital which reveal patient was admitted 11/7/06 w/right sided numbness & tingling of arm, leg & cheek for 15 hours.  Migraine HA normal pattern was 1-2/month but since flu shot had increased to 2-3/week with one episode of difficulty with word finding & writing.  Patient improved with use of steroids. PT/OT/ST evals done. FINAL DX: left pontine lesion, cerebral infarction vs ADEM. 12/14/06 Received medical records from neuro which reveal patient initially evaluated 11/17/06.  Exam revealed: five finger dexterity exam was abnormal on right; decreased response to pain & temp on entire right side; impaired finger to nose movement on right; impaired balance with ataxic gait. Unable to make a clear diagnosis.  MRI was to be repeated in approx 6 mos Final Dx: ADEM vs MS.				Y	Y	3			N	10/26/2006	10/26/2006	0	LABS: CT scan of head revealed low density lesion in left anterior pons.  MRI suggested infarction, neoplasm or possible single demyelination lesion.  MR spectroscopy revealed elevated lactate levels over acetylcholine levels which although not felt to be definitive would be consistent with infarction or demyelination.  TEE was neg.  Carotid US was WNL & was confirmed by MR angiography.  LDL 130, total cholesterol over 200.  LP revealed no WBC, protein 68.8.  C/s neg.  MS studies were pending at d/c.  LABS: MRI of head revealed abnormality in left superior pons c/w subacute infarct, demyelinating lesion or hypercellular tumor.  MRA was WNL.  Additional labs received from hospital revealed CSF showed oligoclonal banding & elevated myelin basic protein c/w acute immune mediated demyelination or MS.	OTH	UNK			Latex, allergic erythromycin.  Allergies: erythromycin, latex & vicodin PMH: mild asthma, hyperlipidemia, migraines, febrile seizures in childhood			1						1	Cerebral infarction; Encephalitis; Hypoaesthesia; Laboratory test abnormal; Migraine; Multiple sclerosis; Nuclear magnetic resonance imaging brain abnormal; Paraesthesia; Speech disorder	FLU3~SANOFI PASTEUR~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0267042	11/16/2006	LA	66.0	66		F	11/16/2006	Received at 1:00 pm - Became very tired about 2 hrs after, by bed time my eyes were burning, I was sneezing, coughing and had a terrible sore throat. had chills, fever that night and next 2 nights.									Y	11/06/2006	11/06/2006	0	NONE	OTH	PVT	NONE	NONE				1						1	Chills; Cough; Eye pain; Fatigue; Pharyngolaryngeal pain; Pyrexia; Sneezing	FLU3~SANOFI PASTEUR~U2245AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267043	11/16/2006	CO	46.0	46		F	11/16/2006	11/15 8:00 Started coughing - burning in lungs and esophagus with each deep breath - pain in lungs. Tightness in chest, ears feeling full and painful, eyes painful. hard to swallow, gums feeling puffy. Face swollen. 11/16 Today face still swollen, eyes with discharge (yellow). feeling very tired.									Y	11/15/2006	11/15/2006	0		OTH	PVT		NONE	Seasonal allergies. When young - allergic to tetanus horse serum			1						1	Chest discomfort; Cough; Dysphagia; Ear discomfort; Ear pain; Eye discharge; Eye pain; Lung disorder; Oesophageal disorder; Pain; Swelling face	FLU3~SANOFI PASTEUR~U2249AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267044	11/16/2006	IA	63.0	63		F	11/16/2006	Pt received Pneumovax 11-13-06; Next day noticed swelling to right deltoid and baseball round induration. Two days later noticed red streaks 3-5 long maybe 3/4 wide encircling upper armpit. Deltoid hot to touch and tender. Also red blotchy, red, raised rash to forearm/elbow. No itching.									Y	11/13/2006	11/14/2006	1		PVT	UNK		NONE	Sulfa; codeine; PCN; pseudoephedrine; ESTRADERM; ERYTHRACIN; tetracycline			1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth; Rash erythematous	FLU3~SANOFI PASTEUR~U2246AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1036P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267045	11/16/2006	PA	2.0	2	.2	M	11/16/2006	Received Influenza vaccine 11/3/06. 11/9/06 had acute onset of facial simple motor tics.				Y					U	11/03/2006	11/09/2006	6		PVT	PVT	NONE	Upper resp infection	NONE			1						1	Tic	FLU3~SANOFI PASTEUR~UT21765~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267046	11/16/2006	MI	35.0	34		F	11/16/2006	11-10-06 Left arm sore weak heavy; 11-11-06 no ss; 11-12-06 no ss; 11-13-06 no ss; 11-14-06 numbness to anterior left side, left eye twitch, speech slurred, left side of face edema; 11-15-06 ss worse.  11/20/06 Received medical records which reveal patient seen in ER with numbness of left face, left eye weakness, left facial swelling, left facial droop.  Left eye was tearing more & was drooling from left side of mouth.  Treated w/steroids & antiviral.  D/C to home from ER to f/u with PCP. Final DX: Bells Palsy./ss				Y					N	11/10/2006	11/14/2006	4		OTH	OTH	MV	NONE	Lumpectomy in June '06			1						1	Asthenia; Drooling; Dysarthria; Face oedema; Facial palsy; Hypoaesthesia; Muscle twitching; Pain	FLU3~SANOFI PASTEUR~U2253AA~7+~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267050	11/16/2006	AL	1.0	1	.0	F	11/16/2006	Right arm with area of 2 cm x 2 1/4 cm erythema. No pain with palpation. Very minor firmness at site.									Y	11/16/2006	11/16/2006	0	CBC done after the immunization	PUB	PUB	NONE	NONE	Anemia			1						1	Erythema; Injection site induration	DTAPH~SANOFI PASTEUR~U1891AB~1~IM~RL~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~U2147HA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~0978F~1~SC~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0267069	11/16/2006	MI	89.0	89		F	11/14/2006	Information has been received from a physician concerning an 89 year old female with high cholesterol, high blood pressure and osteopenia who on 09-OCT-2006 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX. Concomitant vaccination included a dose of influenza virus vaccine (unspecified) on 05-OCT-2006. In the morning of 10-OCT-2006 the patient experienced excruciating body pain, burning and throbbing of ears, pressure in head, stomach pain, severe headache and was lightheaded. She had achiness and tightness with sore muscles of the neck, shoulders and arms. Her entire body was weak, she was unable to turn her head. She also had burning in mouth and tongue. Unspecified medical attention was sought. The patient had improvement, but was not fully recovered. There was no product quality complaint involved. Additional information has been requested.				Y					N	10/09/2006	10/10/2006	1	UNK	PVT	PVT			Cholesterol high; blood pressure high; osteopenia		WAES0610USA12613	1						1	Abdominal pain upper; Asthenia; Dizziness; Feeling hot; Glossodynia; Headache; Hypokinesia; Myalgia; Neck pain; Pain; Paraesthesia oral; Sensation of pressure	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0267073	11/16/2006	PA	66.0	66		F	11/14/2006	Information has been received from a 66 year old female with asthma, restless legs syndrome, and an allergy to an unspecified antibiotic who on 26-OCT-2006 was vaccinated SC with a 0.5 mL dose of ZOSTAVAX. Concomitant vaccination at the same time included a dose of influenza virus vaccine (unspecified). Other concomitant medication included montelukast sodium (MSD), clonazepam (CLONOPIN), and ropinirole hydrochloride (REQUIP). on 26-OCT-2006, nine hours after vaccination, the patient began to itch all over. She was treated with cetirizine hydrochloride (ZYRTEC), but continued to itch all over. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. 6/17/10 Additional informationi has been received from the patient's physician who reported that on 27-OCT-2006, the patient had puritis and a rash and went to the emergency room. The patient recovered on 29-OCT-2006. Medical records revealed that the patient was admitted to the emergency room on 27-OCT-2006 at 19:38 PM. The complaint was reaction to shingles vaccine, rash, itch and voic going. It was noted that the patient had a history of high cholesterol and hypothyroidism. The patient took 40 mg of prednisone and at 20:00 PM no rash was noted. She was alert and oriented, her speech was clear, and no shortness of breath was noted. The clinical impression was that she had an acute allergic reaction to varicella-zoster virus vaccine live ZOSTAVAX (Merck). The patient departed the emergency room at 21:40 PM. Additional information is not expected.				Y					Y	10/26/2006	10/26/2006	0	NONE	PVT	OTH	CLONOPIN, SINGULAIR, REQUIP		Asthma, restless legs syndrome, allergic reaction to antibiotics		WAES0610USA14575	1						1	Aphonia; Pruritus; Rash; Reaction to previous exposure to any vaccine; Varicella post vaccine	FLUX~UNKNOWN MANUFACTURER~U2273A~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~0622F~1~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0267075	11/16/2006	CA	62.0	62		F	11/14/2006	Information has been received from a physician concerning a 62 year old female with a codeine allergy and a history of breast cancer 8 years ago, who on 10/12/06 was vaccinated SC in the arm with a 0.65ml dose of Varicella Zoster vaccine (lot 652966/0722F). Concomitant therapy included Vagifem. Concomitant vaccination included a dose of Influenza vaccine (unspec) given in the other arm on the same day. On 10/28/2006 the pt experienced fever blisters or cold sores on her lips. The pt was seen by a physician on 10/30/06, no lab or diagnostic test were performed. At the time of this report the pt had not recovered. no product quality complaint was involved. Additional information has been requested.				Y					N	10/12/2006	10/28/2006	16	NONE	OTH	OTH	Vagifem, Temazapam		Breast cancer, Drug hypersensitivity.		WAES0611USA00570	1						1	Blister; Lip ulceration	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~0722F~UNK~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0267411	11/16/2006		17.0			F	11/14/2006	Information has been received from a physician concerning a 17 year old female pt with on past medical history who on 10/2/06 was vaccainted with a dose of HPV vaccine, lot 653735/0688F. Concomitant therapy included an unspecified flu shot. It was reported that after receiving HPV vaccine, the pt passed out. Medical attention was sought. the pt recovered the same day. No further information is available.				Y					Y	10/02/2006	10/02/2006	0	NONE	OTH	OTH			NONE		WAES0610USA01138	1						1	Loss of consciousness	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~0688F~UNK~UN~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0267427	11/16/2006	TX	11.0			F	11/14/2006	Information has been received from a physician concerning an 11 year old female who was the daughter of a nurse that works in his office. On 30-SEP-2006 the patient was vaccinated with a 0.5 ml dose of GARDASIL (lot #654540/0800F). At that same time, the patient received a second dose of FLUMIST. On 01-OCT-2006 the patient had a funny feeling in her face. By 03-OCT-2006 her face was crooked on one side and becoming paralyzed. The patient was treated with an unspecified steroid medication and was reported to be feeling better, but the symptoms were not totally gone. The patient was seen by a neurologist and was diagnosed with Bell's Palsy. The physician reported that one year ago, the patient was given FLUMIST and had no adverse reactions. At the time of this report, the patient was recovering from the events. The physician reported that it was his opinion that Bells Palsy was caused by FLUMIST and not GARDASIL. Additional information has been requested.				Y					N	09/30/2006	10/01/2006	1	UNK	OTH	OTH	UNK		UNK		WAES0610USA08291	1						1	Facial palsy	FLUN3~MEDIMMUNE VACCINES, INC.~~2~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0800F~UNK~UN~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0267432	11/16/2006	PA	13.0	13		F	11/14/2006	Information has been received from a physician concerning a 12 year old female with asthma and Advair allergy who on 10/11/06 was vaccinated with HVP vaccine. Concomitant therapy that day included varicella virus vaccine and influenza vaccine. On 10/11/06 the pt experienced numbing at injection site and around arm. The pt recovered. Unspecified medical attention was sought. Additional information has been requested.									Y	10/11/2006	10/11/2006	0	NONE	PVT	PUB			Asthma, drug Hypersensitivity.		WAES0610USA09277	1						1	Hypoaesthesia; Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~0800F~UNK~UN~UN~HPV (GARDASIL)~1|VARCEL~MERCK & CO. INC.~~UNK~UN~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0265991	11/17/2006	FL	30.0	30		M	11/13/2006	Information has been received from a pharmacist concerning a 30 year old hospitalized male with cystic fibrosis and drug hypersensitivity to piperacillin sodium + tazobactam sodium (Zosyn) who on 10/30/06 was vaccinated SW with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine upon discharge from the hospital. Concomitant therapy included Zyvox. Subsequently the pt developed progressive swelling, tenderness and redness to the upper arm in a 7 by 8 cm area. ON 11/2/06, the pt was readmitted to the hospital. At the time of the report, the pt had not recovered. The pharmacist reported that the pt was vaccinated with lot 653283/0001F, 655587/0882F, 654981/0674F or 651149/0088F. The pharmacist could not narrow down which lot number the pt received and requested a lot check for each of them. Additional information has been requested.				Y	Y	0	Y		N	10/30/2006				OTH	OTH	Zyvox		Cystic fibrosis, Drug hypersensitivity, Hospitalisation.		WAES0611USA01593	1						2	Bronchoscopy abnormal; Candidiasis; Cellulitis; Condition aggravated; Cough; Cystic fibrosis lung; Diarrhoea; Electrolyte imbalance; Erythema; Fatigue; Hypokalaemia; Hypomagnesaemia; Induration; Injection site oedema; Injection site pain; Injection site pain; Injection site swelling; Malaise; Mobility decreased; Oedema peripheral; Pain in extremity; Pyrexia; Renal failure; Skin warm; Sputum purulent; Vaccination complication; Vomiting; Injection site erythema; Injection site oedema; Tenderness	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~1~SC~RA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~0001F~UNK~SC~UN~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0266242	11/17/2006	NY		49		F		Pt med with flu vaccine at 1435 went back to work. Called me 1445 stating she was feeling left side numbness from lip to ear progressing to left eye, denies dysphasia or dyspnea.										10/26/2006	10/26/2006	0		UNK	UNK			Asthma, Penicillin, Clindamycin, Vaco mucin, Keflex, Ceclor, Araprox (Anaphylaxis)			1						2	Hypoaesthesia; Hypoaesthesia	FLU3~SANOFI PASTEUR~U2199AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2199AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0266870	11/17/2006	WA	68.0	68		F		Right arm sore, itching, swollen, bright red, hot to touch, very painful to touch, restricted motion. Lasted approximately one week.									Y	10/31/2006	10/31/2006	0		PVT	UNK						1						2	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth; Joint range of motion decreased; Pruritus; Erythema; Joint range of motion decreased; Myalgia; Pain; Pruritus; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71647~3~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0399F~1~~RA~PNEUMO (PNEUMOVAX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71647~3~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~0399F~1~~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0267049	11/17/2006	VT	8.0	8		M	11/16/2006	Thirty-six hours following injection noted redness, swelling and warmth progressing over next 12 hours. No fever, systemic signs of illness.				Y					Y	11/14/2006	11/15/2006	1		PVT	PVT	Flovent, Albuterol	NONE	Allergies to feathers, animals			1						1	Erythema; Feeling hot; Swelling	FLU3~SANOFI PASTEUR~U2243AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267089	11/17/2006	MI	30.0	30		F	11/13/2006	Seriousness criteria other medically significant (OMIC). A 30 year old female pt received an initial dose of Adacel, lot number C2559AA, administered in the left deltoid, and a dose of influenza vaccine, lot number not reported, administered in the right deltoid on 11/3/06. The needle sizes and gauges were not known. 24 hours later, the pt experienced severe body aches, systemic anorexia, lethargy, and a temp of 101 degs F. Her left deltoid was swollen at the site of injection to golf ball size and was red and painful. the pt also experienced a headache, for which she took Motrin as needed. It was not reported whether the pt required any medical intervention. The pt reported that her body aches subsided by 11/6/06. At the time of this report on 11/7/06, the local site swelling, pain and lethargy continued and the pt had not recovered.				Y					N	11/03/2006	11/04/2006	1		PVT	UNK			The patient has a history of allergies to codeine and Imitrex.		200602978	1						1	Anorexia; Headache; Injection site erythema; Injection site oedema; Injection site pain; Lethargy; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C2559AA~1~~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0267094	11/17/2006	WI	1.0	0	1	M	11/13/2006	10/17/06 given MMR-V, Hep B-Hib, Hep A, and Flu vaccine. 10/31/06 acute onset transverse myelitis.  12/4/06 Received medical records from hospital which reval patient admitted 10/31/06-11/21/06 for generalized weakness & inability to move extremities well x 1 day.  Had viral URI s/s for approx 1 day. Neuro exam revealed global weakness & decreased tone from the neck down.  Had diminished cry.  Developed UGI bleed possibly secondary to high dose steroids.  Developed ileus probably secondary to ADEM.  Treated with decompression & multiple anti virals & antibiotics.  Neuro, GI & PM&R followed patient & was to received services at home upon d/c. Final Dx: probable ADEM.  Pneumatosis intestinalis, resolved.  Anemia requiring multiple transfusions. Per 60 day follow up: Not fully back to his baseline. He still has grars and fine motor delays. Not sitting unassisted. His getting weekly OT and PT. He has lower extermity atrophy. He is making slow progress developementally. He still has global developmental delays.					Y				N	10/17/2006	10/30/2006	13	Abnormal brain/spine MRI LABS: CT of head was WNL. MRI of head & spine consistent with ADEM or transverse myelitis.    LP of 10/31 revealed protein 85, RBC 530, neutro 68, lymphs 9, eos 1 baso 1, glucose 52.  LP of 11/6 revealed protein 42, RBC 44, lymps 17, mono 71, macrophages 12, glucose 78. CSF myelin basic protein 16.6.All cultures neg.  CRP 23.9.  ESR 84	PVT	PVT	NONE		Shaken baby syndrome at 7 months of age.  PMH: right frontoparietal subdural hemorrhage that extended into the interhemispheric fossa & intraretinal hemorrhages that resolved at 7 mos of age.  Shaken baby syndrome secondary to a daycare provider. Birth HX: 39 4/7 gest age & born via normal SVD.			1						1	Acute disseminated encephalomyelitis; Anaemia; Asthenia; CSF glucose increased; CSF lymphocyte count abnormal; CSF monocyte count increased; CSF neutrophil count increased; CSF protein increased; CSF test abnormal; Crying; Fine motor delay; Gastrointestinal haemorrhage; Hypotonia; Ileus; Laboratory test abnormal; Lumbar puncture abnormal; Muscular weakness; Myelitis transverse; Nuclear magnetic resonance imaging brain abnormal; Nuclear magnetic resonance imaging spinal cord abnormal; Occupational therapy; Physiotherapy; Pneumatosis intestinalis; Red blood cell sedimentation rate increased; Red blood cells CSF positive; Spinal muscular atrophy; Transfusion; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~U2257AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~6356R~3~~LL~HIB + HEP B (COMVAX)~1|HEPA~MERCK & CO. INC.~1008F~1~~LL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~0661F~1~~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Hospitalisation	Influenza
0267096	11/17/2006	IL	72.0	72		F	11/10/2006	Pt developed confusion, decreased spontaneous speech, tremors, muscle rigidity and gait unsteadiness a day after getting the flu shot in a church.					Y	0				11/04/2006	11/05/2006	1		UNK	UNK			Patient has a history of DM, HTN, anemia			1						1	Confusional state; Gait disturbance; Muscle rigidity; Speech disorder; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0267098	11/17/2006	NV	44.0	44		M	11/14/2006	Erythema, fever, chills 24 hours post injection				Y					Y	11/10/2006	11/11/2006	1		PUB	PVT						1						1	Chills; Erythema; Pyrexia	FLU3~SANOFI PASTEUR~U2218AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0485F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0267099	11/17/2006	WA	3.0	3		M	11/13/2006	Swelling under right eye. Red flat spot on chest, back and legs. Swelling going away in face already.									Y	11/13/2006	11/13/2006	0		PVT	PUB		NONE	NONE			1						1	Erythema; Swelling	FLU3~SANOFI PASTEUR~U2219AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0741F~1~IM~UN~HEP A (VAQTA)~1	USA		Influenza
0267101	11/17/2006	TN	10.0	10		M	11/13/2006	Mother of patient called Monday 11-13-06. States child got fever 102 degrees three hours after receiving Fluzone flu vaccine 0.5 ml and bad headache. Still headache next day with fever 101 degrees (11-11-06). On 11-21-06, headache a little better with fever 99-100 degrees.									Y	11/10/2006	11/10/2006	0		PVT	PVT	UNK	UNK	NONE			1						1	Headache; Pyrexia	FLU3~SANOFI PASTEUR~U2169MA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267102	11/17/2006	NY	60.0	59		F	11/13/2006	Right arm redness, warm and tender. Hardness around area where vaccine was given. Bloodwork ordered, Augmentin ordered. follow up next day.										10/10/2006	10/10/2006	0		PVT	UNK	Advair, Prednisone, Ecotrin, Triamterene-hctz, Proventil, K-dur, Norvasc, Atenolol					1						1	Erythema; Feeling hot; Injection site induration; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70279~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0087F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267103	11/17/2006	IN	32.0	31		F	10/30/2006	Treated in hospital for Right arm pain, fever of 101.0. Small bruise at injection site. 10-30-06 Patient complains of arm pain and swelling. Stated it is not any worse.				Y					Y	10/27/2006	10/28/2006	1	X-ray of right arm-negative	OTH	PVT		NONE	NONE			1						1	Contusion; Pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U2192AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0743F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0267104	11/17/2006	NY	75.0	75		M	11/13/2006	Redness and swelling at injection site within 5 hours. Travels to elbow. Saw a Dr on 11-13-06, placed on antibiotic. Arm still red and swollen. Recommended ice to be used.				Y					U	11/10/2006				PUB	UNK		NONE	NONE			1						1	Injection site erythema; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70619~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0899~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0267105	11/17/2006	PA	8.0	8		F	11/10/2006	Patient getting squeezing in chest.  Not able to bet in a deep breath.  No couth.  Getting DOE.  No temp elevation.  O2 sat 98%.  CXR neg.  Albuterol inhaler provided relief and prescription given for albuterol MDI. 11/20/06 Received medical records from provider which reveal patient in good health but with AM stomach aches even on non school days.  Peppermint candy relieves.  Poor appetite.  Received FluMist on 10/27 & became ill on 10/28 with squeezing in chest & SOB.  Treated w/albuterol MDI.  CXR was WNL.				Y					Y	10/27/2006	10/28/2006	1	CXR neg.  O2 saturation 98%.	PVT	PUB	NONE	Constipation	Allergic to bees.  Asthma.			1						1	Chest pain; Decreased appetite; Dyspnoea	FLUN3~MEDIMMUNE VACCINES, INC.~500439P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0267106	11/17/2006	UT	21.0	21		F	11/09/2006	Shortness of breath, red and swollen eyes, rash on neck and chest, hypotension, tachycardia, chest pain. Developed in evening after receiving vaccine at approximately 1pm. Treated in ER for possible allergic reaction to flu vaccine. 1st flu shot employee had ever received.				Y					U	10/10/2006	10/10/2006	0	WBC 14.9 on 10/11/06; DD QNT 957 10/10/06; K+3.1	PVT	PVT	Benadryl, birth control, Ibuprofen	NONE	MD dictation states unremarkable.			1						1	Chest pain; Dyspnoea; Eye swelling; Hypotension; Ocular hyperaemia; Rash; Tachycardia	FLU3~SANOFI PASTEUR~U2177AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267107	11/17/2006	PA	4.0	4		F	11/10/2006	Developed headache, fever, earache, vomiting. Diagnosed with right otitis media 24 hours after nasal flumist. Temp in office 101.7 F.				Y					Y	11/09/2006	11/10/2006	1		PVT	PUB	Lotrisome	Eczema	Omnicef allergy			1						1	Ear pain; Headache; Otitis media; Pyrexia; Vomiting; Wrong drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500439P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0267108	11/17/2006	GA	4.0	3		F	11/13/2006	Swelling, hot to the touch, itching.									Y	11/09/2006	11/09/2006	0	NONE	PVT	PVT	Zyrtec, Singular, Pepcid AC	NONE	Allergy to egg whites			1						1	Feeling hot; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U2167NA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267109	11/17/2006	TN	6.0	6		F	11/10/2006	Bell's palsy on Right and weak right eyelid, decrease scotopic threshold response, asymmetric smile, able to follow brow bilateral seems to be improving. No treatment. 12/18/06 Received medical records from reporter which reveal patient seen 7/06 & dx w/strep throat, treated/resolved & then otitis media, treated/resolved.  Received flu shot at pharmacy on 10/11. Seen by reporter on 11/3/06 after being evaluated by eye dr who dx bells palsy.  Facial weakness had been present for approx 1 week. Right eyelid weakness, right corner of mouth drooping, able to wrinkle forehead bilaterally.  Temp 99.5. Final Dx: Bells Palsy.  Mother reported to reporter on 12/6/06 that all symptoms had resolved.				Y						10/11/2006	10/27/2006	16	NONE	OTH	PVT	NONE	NONE	None but broke left arm 3 days earlier. Strep throat 7/06 Otitis media ?date			1						1	Facial palsy; Ophthalmoplegia; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69897~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0267110	11/17/2006	CA	62.0	61		F		That evening just not feeling well. Serum going in arm was very uncomfortable. Arm from shoulder to elbow hurt rest of day. Next day woke up with very rapid racy heart beat, weakness, dizziness, slight nausea.  All symptoms lasted two full days and night. Slight recurrence 5 days later lasting half of day with same symptoms.									Y	10/25/2006	10/26/2006	1		PVT	UNK		NONE	NONE			1						1	Asthenia; Dizziness; Heart rate increased; Nausea; Pain; Vaccination complication	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0267111	11/17/2006	OH	3.0	2	.5	M	11/08/2006	Mom reports: redness and warmth. 3 inch circumference at site of injection left thigh.									Y	11/06/2006	11/07/2006	1		PVT	PVT		NONE	Asthma			1						1	Erythema; Feeling hot	FLU3~SANOFI PASTEUR~U2243AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267112	11/17/2006	CA	5.0	5		F	11/09/2006	Had influenza vax given 11/7/06 in left thigh. 24hours later had pain in leg and did not want to walk. Developed red raised bumps which later became a ringed area around inject site and swelling went down. Associated malaise.										11/07/2006	11/08/2006	1		OTH	OTH		NONE	Asthma			1						1	Difficulty in walking; Injection site swelling; Malaise; Pain	FLU3~SANOFI PASTEUR~U2237AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267114	11/17/2006	MT	3.0	3		F	11/14/2006	DTAP-arm turned red from elbow to shoulder;Varicella-rash approximately 1/2 in around needle site; Flu-rash around needle site approximately 1 inch				Y					U	11/14/2006	11/14/2006	0		PUB	UNK		NONE				1						1	Erythema; Injection site rash	FLU3~SANOFI PASTEUR~U2218AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0931F~1~~LA~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~0795F~1~~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0267116	11/17/2006	PA	1.29	1	.3	F	11/14/2006	11 days after vaccine, Right injection with red bump				Y					U	11/03/2006	11/14/2006	11	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site nodule	FLU3~SANOFI PASTEUR~U2169MA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0495F~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0267117	11/17/2006	ME	23.0	23		F	10/31/2006	7:55 a.m. Client received a flu shot in left deltoid. Gave her a sheet on (What you need to known 2006-07 Influenza vaccines. instructed her to stay around people for the next 30 minutes in case of an allergic reaction. 8:10 a.m. Client came back to office complaining that her throat feels tight and has tingling in her hands. Client states My throat started feeling different when I got back to class but it kept getting worse. My throat has a fullness to it now it is getting worse. 8:15 a.m. Epi-pen 0.3 mg administered to RIGHT THIGH LOT#5EM436 expires 03/07. 2 Puffs from Albuterol inhaler and Benadryl (50mg) given. Person name called ambulance service and client's husband. Blood pressure 140/80, pulse 90. 8:25 a.m. Ambulance Service arrived and transported to hospital emergency room.				Y					Y	10/27/2006	10/27/2006	0		UNK	UNK		NONE	NONE			1						1	Paraesthesia; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA208BA~1~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0267118	11/17/2006	MA	68.0	68		M	11/15/2006	Clinic participant complained of sudden, non-radiating lower back pain after receiving injections. Pain resolved after sitting for approximately 10 minutes. Pulse was 76 beats/minutes. Blood pressure 140/80. Ambulance was called. Client symptoms had resolved. He declined to be assessed at ER. Primary HCP notified.									Y	11/13/2006	11/13/2006	0		PUB	PUB	ENALAPRIL 10mg QD, ADVAIR 250/50 BID, SPIRIXA QD, ALBUTEROL MDI, METFORMIN ER 500mg BID	NONE	NIDDM, HTN, Asthma ?COPD, Allergic- Penicillin			1						1	Back pain	FLU3~SANOFI PASTEUR~U2279AA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0601F~3~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267119	11/17/2006	MA	51.0	51		F	11/14/2006	Abdominal cramping and diarrhea for 72 hours.									Y	11/08/2006	11/08/2006	0		PUB	PUB			NONE			1						1	Abdominal pain; Diarrhoea	FLUX~UNKNOWN MANUFACTURER~71210~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0267120	11/17/2006	MA	29.0	28		F	11/14/2006	Diarrhea with abdominal pain. 6cm area of redness, swelling and warmth at injection site with itching for 3 days.									Y	11/08/2006	11/08/2006	0	NONE	PUB	PUB		NONE	NONE			1						1	Abdominal pain; Diarrhoea; Erythema; Feeling hot; Pruritus; Swelling	FLUX~UNKNOWN MANUFACTURER~71210~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0267121	11/17/2006	PA	74.0	73		F	11/10/2006	Shortly after vaccine, at home patient felt pain, developed edema and redness of right arm(upper). With range of motion -she had more severe pain. Took Tylenol and applied ice to area. This lasted through the next day Wednesday and some on Thursday. Friday (11-10-06), pain subsided to about 15%. Edema decreased. Has red blotches. Called home health nurse.										11/07/2006	11/07/2006	0	NONE	PUB	PVT		NONE	NONE			1						1	Erythema; Oedema; Pain; Rash macular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2Fb011611~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1137P~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267122	11/17/2006	DC	1.22	1	.2	M	11/02/2006	The child received the Flu shot on 11/1/06 in the Right thigh. During the evening mom stated he started to wheeze, began breakingout with hives on both cheeks, Left axillary and both thighs.				Y					Y	11/01/2006	11/01/2006	0		PUB	PUB		NONE				1						1	Urticaria; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~UT2176JA~2~IM~RL~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0267123	11/17/2006	NC	53.0	60		F	10/25/2006	Per employer, she received flu vaccine at work on 24-OCT-2006 at approximately 8:15 am. The only symptom reported on Thursday was red eyes. 25-OCT-2005 when she got out of bed she noted a tingling sensation of both her tongue and face. When she looked in the mirror she observed that her face was flushed and both lips were swollen. She denied any difficulty with breathing or swallowing.									Y	10/24/2006	10/25/2006	1	NONE	UNK	UNK	NONE		NONE			1						1	Flushing; Ocular hyperaemia; Paraesthesia; Swelling face	FLU3~SANOFI PASTEUR~U2177AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267125	11/17/2006	IL	0.59	0	.6	F	11/17/2006	High fever 103.9. No other symptoms.				Y					Y	11/01/2006	11/01/2006	0		PUB	PVT		NONE				1						1	Pyrexia	FLU3~SANOFI PASTEUR~01861AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267126	11/17/2006	IN	36.0	35		F	11/17/2006	Injection at 10:45-headache by noon within 2 hours. Noticed flashes, fatigue, shivering, flushed skin. Over day 1 and day 2; on day 3 swelling of hands, face, chest hurt, red skin, generalized itching. Required MD attention and adrenalin injection at local immediate care facility.									Y	11/10/2006	11/10/2006	0	UNK	OTH	OTH	Levoxyl, Ambien	NONE	Cortisone, morphine, adhesive tapes, benzoin, NSAIDS			1						1	Chest pain; Chills; Erythema; Fatigue; Flushing; Headache; Pruritus; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA234AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0267127	11/17/2006	MO	1.9	1	.9	F	11/13/2006	Acute onset crying, grunting respiration, fever, distress.  11/30/06 Received medical records from PCP which reveal patient in good health on day of vax.  Returned to office after waking from nap crying & shaking & grunting with each breath.  PCP felt it was probable immunization reaction & after about 2 hours of observation in the office was sent home.  Symptoms returned & worsened at home & was admitted to hospital for additional management & observation.  Temp on admit was 103 & patient had faint lacy macular rash over her arms, legs & torso.  CXR & abdominal films were WNL./ss 12/8/06 Received medical records from hospital which reveal patient admitted to hospital 11/9/06 with acute grunting & fever, rule out sepsis or intussusception.  Continued to improve while hospitalized & was d/c to home on 11/11/06.  No d/c summary included with records & no final dx available.				Y	Y	2			Y	11/09/2006	11/09/2006	0	LABS: WBC on admit 15.2, segs 79, monos 14.  CRP 2.3 on admit & was 5.8 next day.  One set of blood cultures grew strep viridans were was felt to be contamination.  CXR & abd xrays were WNL.	PVT	UNK						1						1	Agitation; Crying; Grunting; Pyrexia	FLU3~SANOFI PASTEUR~UT2157DA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0267128	11/17/2006	NC	19.0	19		M	11/16/2006	Description: 19 year old male developed multiple symptoms after vaccination with SPV, JEV, and Flumist. Symptom: Epistaxis start: 11/07/2006. Comment: Reports an episode of 1.5hrs of bleeding on last week. One episode of 10 minutes on yesterday. Reports a problem of 'chronic nosebleeds' in the past and prior to vaccination. Symptom: Pain start: 11/07/2006. Comment: Reported pain in his neck and back since last week, helped by Tylenol. Symptom: Lymphadenopathy, axillary. Start: 11/07/2006. Comment: Very painful left axilla on last week; resolved now. Symptom: Fever. Start: 11/08/2006. Comment: Patient has felt feverish but his measured temps have been normal. Temp yesterday was 98-98.7F. Symptom: Chills. Start: 11/08/2006. Comment: Alternating with the previous fever. Symptom: Vomiting. Start:11/13/2006. Comment: X 1 episode with 'streaks' of blood. Symptom: Anorexia. Start: 11/07/2006. Comment: patient reports his appetite had been decreased by half for the past few days.				Y					Y	10/31/2006	11/07/2006	7	Diagnostic Tests: None; Labs: Patient is referred to WAMC lab for a CBC.	MIL	MIL		NONE	Allergies: Sulfur; no medical conditions, no birth defects.			1						1	Chills; Decreased appetite; Epistaxis; Lymphadenopathy; Pain; Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|JEVX~UNKNOWN MANUFACTURER~~1~UN~UN~JAPANESE ENCEPHALITIS (NO BRAND NAME)~1|SMALL~UNKNOWN MANUFACTURER~~1~~UN~SMALLPOX (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0267136	11/17/2006	MI	4.0	4		M	11/13/2006	Patient seen in ER 11-NOV-2006 14:45. Mother reported itching on left thigh 10-NOV-2006. 11-NOV-2006 noticed redness and swelling and warmth left thigh. Treated with Benadryl 25 mg PO every 6 hours until symptoms gone. Prenisone 5 mg and ice to area.				Y					Y	11/09/2006	11/10/2006	1		PVT	PVT	NONE	NONE	NONE			1						1	Feeling hot; Injection site erythema; Injection site swelling; Pruritus	DTAP~SANOFI PASTEUR~C2278AA~5~IM~LL~DTAP (DAPTACEL)~1|FLUX~UNKNOWN MANUFACTURER~71827~2~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~SANOFI PASTEUR~Y0323~5~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0377R~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0267139	11/17/2006	NE	56.0	56		F	11/17/2006	Lips numb, tongue tingling, check neck back. Heart racing, palms sweating, very tired, explosive diarrhea in the night.									Y	11/15/2006	11/15/2006	0		OTH	PUB	methimazole	Cough	Sulfa, propanol, effexar			1						1	Diarrhoea; Fatigue; Heart rate increased; Hyperhidrosis; Hypoaesthesia; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0267140	11/17/2006	MA	2.0	2	.1	F	11/17/2006	Received only influenza vaccine 11/16/06. Awoke with mild-moderate ataxia within 24 hours. Otherwise well. No evidence of weakness but DTR's 1+ equal bilaterally. No nystagmus. EOMs normal.				Y					N	11/06/2006	11/17/2006	11		UNK	UNK	None	none	none			1						1	Coordination abnormal	FLU3~SANOFI PASTEUR~UT2176BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267141	11/17/2006	FL	37.0	37		M	11/17/2006	Patient administered FLUMIST vaccine and one week post vaccine, patient developed flulike syndrome, followed by fatigue and shortness of breath that worsened over 6 weeks before being referred to local cardiologist presenting with severe cardiomyopathy and associated congestive heart failure. 12/22/06 Received medical records from hospital which reveal patient admitted 11/10/06-11/14/06 after having flu like s/s of fever, malaise & body aches for approx 1 week after received the FluMist vax, followed by SOB & fatigue that continued to worsen over approx 6 wk period before presented to cardiologist office profoundly symptomatic.  Exam revealed JVD & est CVP of 10-12; summation gallop; small amount of ascites; trace bipedal edema Final DX: Congestive heart failure, compensated; cardiomyopathy, severe & presumably post-viral.			Y	Y	Y	4			Y	09/11/2006	09/18/2006	7	TSH 4.9, ANA pending, rheumatoid factor negative LABS: echo showed 10-15% ejection fraction, mild mitral regurg & reduced cardiac output.	MIL	MIL	Lisinopril 20MG HYDROCHLOROTHIAZIDE 25MG	None	Moderate Hypertension PMH: HTN treated intermittently for approx 10 years.			1						1	Ascites; Cardiac failure congestive; Cardiomyopathy; Dyspnoea; Fatigue; Influenza like illness; Laboratory test abnormal; Oedema peripheral	FLUN3~MEDIMMUNE VACCINES, INC.~500433P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Life Threatening,Hospitalisation	Influenza
0267142	11/17/2006	WI	52.0	54		F	11/17/2006	sore throat, achiness, and edema bil eyes.									Y	10/23/2006	10/23/2006	0		UNK	UNK			2-events of hives, unknown source.			1						1	Eye oedema; Pain; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~62165BB~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267143	11/17/2006	PA	78.0	78		F	11/17/2006	I received the vaccine on 11/13/06 at 11:15 AM. About 8 hours later I began to feel a slight sore throat and earache.  However, at about midnight I developed a severe anxiety attack and depression, which lasted for about 7 hours.  It was accompanied by a very low (96.8) temperature and chills. All of the symptoms subsided by about 8:00PM on November 14.									Y	11/13/2006	11/13/2006	0		UNK	UNK	None	None	Hashimoto's thyroiditis, mild hypertension.  Allergy to ragweed.			1						1	Anxiety; Chills; Depression; Ear pain; Pharyngolaryngeal pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0267144	11/17/2006	VA	68.0	68		M	11/17/2006	Patient recieved flu shot on 10/21/06 and started having flu symptoms (myalgias and night sweats) shortly afterward on 10/28/06. The patient also developed severe itching all over his body (which was not relieved by Benadryl) shortly after recieving the vaccine. By 10/30/06, the flu symptoms had gone away, but he still had itching all over his body. He was seen by his primary care physician on 10/30/06 and had jaundice of the skin and eyes.				Y					Y	10/21/2006	10/28/2006	7	10/30/06: glucose 218, creatinine 1.6, albumin 3.0, bilirubin 4.5, alk phos 318, AST 78, ALT 115 11/3/06: glucose 206, creatinine 1.3, albumin 3.0, bilirubin 1.3, alk phos 385, AST 133, ALT 126 11/8/06: glucose 182, creatinine 1.6, albumin 3.4, bilirubin 1.2, alk phos 241, AST 34, ALT 60	UNK	UNK	Aspirin 81 mg QD, Zantac 300 mg BID, Cialis 20 mg PRN, Lotrisone cream PRN, Cozaar 100 mg QD, Glucophage 1000 mg BID, Norvasc 5 mg QD, Lipitor 40 mg QD, Prilosec OTC 20 mg QD, Atenolol 50 mg QD, Indomethacin 25 mg-50 mg q6h PRN gout, Avandi	none	Type 2 Diabetes, hyperlipidemia, hypertension, esophageal reflux, impotence, seborrheic dermatitis, gout, depression, osteoarthritis, tinae cruris,			1						1	Influenza; Jaundice; Myalgia; Night sweats; Pruritus	FLU3~SANOFI PASTEUR~U2275AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267145	11/17/2006	WA	28.0	28		F	11/17/2006	sore throat, cough, nasal congestion, runny nose, weakness, fatigue, slight difficulty breathing, very slight wheezing, soreness									U	11/16/2006	11/16/2006	0		UNK	UNK	Lamictal, 200 mg BID		Juvenile Myoclonic Epilepsy			1						1	Asthenia; Cough; Dyspnoea; Fatigue; Nasal congestion; Pain; Pharyngolaryngeal pain; Rhinorrhoea; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0267146	11/17/2006	WI	2.0	2	.4	M	11/17/2006	none known									U	11/15/2006			none known	UNK	UNK						1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2174HA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2457AA~4~IM~RL~TDAP (ADACEL)~1	USA		Influenza
0267147	11/17/2006	IL	85.0	85		F	11/17/2006	Patient stated that right arm (pneumonia given in) somewhat pink in color and swollen where injections was given.  It was recommended for them to apply ice....if temp. or difficulty in breathing notify physician									Y	10/26/2006	10/27/2006	1	Unknown	UNK	UNK	unknown	unknown	unknown			1						1	Injection site erythema; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69428~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0485F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267148	11/17/2006	MD	10.0	10		M	11/17/2006	Skin rash on chest, legs and arms				Y					U	11/14/2006	11/16/2006	2		UNK	UNK		none	none			1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~IN~NS~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0267149	11/17/2006	IL	85.0	85		F	11/17/2006	Pain in Rt. arm this was arm flu shot was given in...We suggested that he elevate arm.....took tylenol.									Y	11/07/2006	11/07/2006	0	Unknown	UNK	UNK	Unknown	Unknown	Unknown			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U2189AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0985F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267150	11/17/2006	IL	77.0	77		F	11/17/2006	Client complained of redness, swelling and pain  to right arm.									U	11/01/2006	11/01/2006	0	Unknown	UNK	UNK	Unknown	Unknown	Unknown			1						1	Erythema; Pain; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70385~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0618F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267151	11/17/2006	IL	46.0	46		F	11/17/2006	Warm and redness around injection site									Y	10/30/2006	10/30/2006	0	Unknown	UNK	UNK	Unknown	Unknown				1						1	Injection site erythema; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70385~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267156	11/17/2006	TX	48.0	48		F	11/17/2006	Continuous thick yellow discharge from eyes, deep cough, fever 101, body aches and weakness, cold shivers. Fever, shivers, eye discharge lasted 24 hours. Body aches, weakness, and cough lasted 8 days. Advil only treatment.									Y	11/07/2006	11/07/2006	0	none	UNK	UNK	Multivitamin, Calcium citrate, Selenium, Vit C, Ester C, L-Glutamine	none	Allergic to sulfa drugs.			1						1	Asthenia; Chills; Cough; Eye discharge; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~unknown~1~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0267157	11/17/2006	MO	8.0	8		F	11/17/2006	Mom calls 11/16/06 to say arm at site if immunization is red, warm swollen, sore to touch, and has low grade fever.  Treatment recommended: ibuprofen,warm moist packs to site									U	11/14/2006	11/16/2006	2	none	UNK	UNK	nonenone	none				1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U2174AA~6~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267158	11/17/2006	CA	56.0	56		F	11/17/2006	Rashes on forehead.				Y					Y	11/14/2006	11/16/2006	2	Lipids, Glucose, Liver Function Panel	MIL	MIL	Allegra 180 mg	none	Allergic Rhinitis			1						1	Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA223AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0267160	11/17/2006	RI	1.01	1	.0	M	11/17/2006	1.5 INCH X 1.5 INCH RED BLOTCH NOTED TO RT LEG.									N	11/06/2006	11/13/2006	7		MIL	MIL						1						1	Erythema	FLU3~SANOFI PASTEUR~U2244AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1181R~3~IM~RL~HIB (PEDVAXHIB)~1|MMRV~MERCK & CO. INC.~1130R~2~IM~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08682H~5~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0267161	11/17/2006	RI	1.02	1	.0	F	11/17/2006	1.5 IN x 1.5 IN RED BLOTCH TO UPPER RT THIGH.									N	11/06/2006	11/13/2006	7		MIL	MIL						1						1	Erythema	FLU3~SANOFI PASTEUR~U2174GA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB110AA~UNK~IM~LL~HEP A (HAVRIX)~1|HIBV~MERCK & CO. INC.~1181R~UNK~IM~LL~HIB (PEDVAXHIB)~1|MMRV~MERCK & CO. INC.~1130R~UNK~IM~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08682H~UNK~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0267163	11/17/2006	FL	66.0	66		F	11/17/2006	felt fine day flu was administered. on 11/7/2006 didn't feel good. stated heart rate was up (100) bp was 115/62. had difficulty breathing was dizzy,having chills and felt wacky was hallucinating and balance was off. Felt like she had decrease in consciousness. Felt ok the second day, but symptoms returned on the third day for five more days. Today her legs are still jerky and her balance is still off.									N	11/06/2006	11/07/2006	1		UNK	UNK	estrogen patch	denies	none known			1						1	Balance disorder; Chills; Depressed level of consciousness; Dizziness; Dyspnoea; Hallucination; Heart rate increased; Muscle spasms	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71646~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267164	11/17/2006	CA	0.64	0	.6	M	11/17/2006	rashes, swelling lower eyes				Y					Y	11/13/2006	11/13/2006	0	Referral for Allergy Tests	UNK	UNK	Tylenol gtts 4-6	cold	None			1						1	Eye oedema; Rash	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B073AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2174GA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~UNKNOWN MANUFACTURER~0541R~3~IM~RL~HIB (NO BRAND NAME)~1|PNC~PFIZER\WYETH~B08666E~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0267165	11/17/2006	SC	65.0	65		M	11/17/2006	Fever, headache x2 days, Right upper extremity redness and swelling on the lower half of the upper arm (proximal to the elbow), hot and tender to palpation.  All per patient report.									Y	11/15/2006	11/16/2006	1		MIL	MIL	Metrogel for rosacea	mild congestion				1						1	Erythema; Headache; Injection site warmth; Oedema peripheral; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~U2285AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1008P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267167	11/17/2006	WI	62.0	62		F	11/17/2006	Within 24 hours arm was itching, 48 hours post vaccination arm was hot to touch, swollen and red.									U	11/15/2006	11/16/2006	1	UNKNOWN	UNK	UNK	unknown	no	unknown			1						1	Erythema; Injection site warmth; Pruritus; Swelling	FLU3~SANOFI PASTEUR~u2212aa~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267169	11/17/2006	AZ	57.0	57		F	11/17/2006	urticaria/myalgias beginning 12 hrs post injection. urticaria lasted 3 days, myalgias continued for 10-14 days.  symptomatic with acetoaminphen.  note: patient had similar, but milder reaction to flu vaccine in 1998-no vaccine in 1999/2000, but has had annually since 2001 without problem until now.				Y					Y	11/03/2006	11/04/2006	1	lab at ER one wk (11-10-06) post vaccine all nl inc cbc (wbs 8.8 and chem 20/lfts	UNK	UNK	relpax,topamax,valsartan,prevacid,simvastatin,coumadin	none	dm, type2, fibramyalgia, osteoporesis, migraines, s/p aortic valve replacement.			1						1	Myalgia; Similar reaction on previous exposure to drug; Urticaria	FLU3~PFIZER\WYETH~aflua222aa~5~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0267171	11/17/2006	MN	13.0	12		F	11/17/2006	INfluenza vaccine and Human Papilloma VIrus vaccines  given November  10 about 11:45 AM. Patient woke up with numbness on right side of face on November  11.  Presented to Emergency Room on November 12 with Bells Palsy of  right side of face. Unable  to move right side of face.  Unable to close right eye.  Previously healthy, no symptoms on day of vaccine administration.  Received MR from pediatrician revealing a healthy 12 year old in for well-child exam. 24 hours after Flu and Gardasil vax. child developed numbness, pain, and inability to move the right side of face. Assessment:  Facial Nerve Palsy-unclear etiology. Child was sent by car to Minneapolis Children's ER to be evaluated. ER report received:  DX: Bell's Palsy				Y					U	11/10/2006	11/11/2006	1		UNK	UNK	NONE	none	none			1						1	Facial palsy; Hypoaesthesia; Pain; Paralysis	FLU3~SANOFI PASTEUR~U2244AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~08668F~1~IM~RA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0267185	11/17/2006	PA	19.0	19		F	11/17/2006	This case was reported by a consumer and described the occurrence of paralysis in a 19 year old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. The subjects medical history included primary immune deficiency. Concurrent medications included antibiotics. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On an unspecified date in Nov 2005 the subject received a dose of Influenza virus vaccine. Approx nine hours later, on an unspecified date in Nov 2005, the subject experienced tiredness. During that night following receipt of influenza virus vaccine, the subject experienced muscle spasm at night, heart racing and a fluttering feeling in her muscles, such that she could not move. The subject went to the doctor the day after these events for IV immunoglobulin (for primary immune deficiency) not because of the reaction she had during the night. The doctor checked her out and she seemed fine. The events were considered disabling. At the time of reporting the events were resolved.				Y				Y	Y	11/01/2005	11/01/2005	0		PUB	OTH	Antibiotics		Immune deficiency		A0627852A	1						1	Fatigue; Heart rate increased; Muscle disorder; Muscle spasms; Paralysis	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0267189	11/17/2006	CA		27		F	11/17/2006	Felt achy, chills. Went to bed early. Next day was numb on vaccine site, aches, pain, nausea, fever. Talked to the nurse who recommended Tylenol for pain but because of nausea was unable to keep it down. Nausea and aches are gradually going away, feels better today.				Y					Y	11/15/2006	11/15/2006	0		OTH	PUB	Calcium	No	Lactose intolerant			1						1	Chills; Injection site anaesthesia; Nausea; Pain	FLUX~UNKNOWN MANUFACTURER~~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0267190	11/17/2006	WI	53.0	52		F	11/17/2006	Patient phoned stating she was treated in ER for yellow drainage from eyes, tightness in throat, lips swelling and increased blood pressure				Y						11/16/2006	11/16/2006	0		OTH	PUB						1						1	Blood pressure increased; Eye discharge; Swelling face; Throat tightness	FLU3~SANOFI PASTEUR~U2254AA~UNK~ID~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267191	11/17/2006	OH	5.0	5		M	11/14/2006	Severe pain at injection site				Y					Y	11/13/2006	11/13/2006	0	NONE	PVT	PVT			NONE			1						1	Injection site pain	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1036P~1~~RL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0267192	11/17/2006	NH	46.0	45		F	11/16/2006	Nurse gave patient 0.1 ml intra dermal injection of flu instead of 0.1 ml of PPD intra dermal. PPD vaccine 11/17/06 red, slightly warm to touch at side of influenza injection site.									U	11/15/2006			N/A	PVT	PVT	Synthroid, ativan, ortho tri cyclen, folic acid, methotrexate, tegretol, multivitamins, vitamin E, fish oil, Plaquenil		Hypertension, arthritis, hypothyroidism, hyperlipidemia, anxiety, history of abnormal pap smear, syndrome postconsussion, perimenopausal, overweight, S/P BTL, alopecia, NOS, tachycardia NOS, dysmetabolic syndrome		NH0617	1						1	Erythema; Feeling hot; Medication error	FLU3~SANOFI PASTEUR~U2247AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267193	11/17/2006	NY	58.0	58		M	11/17/2006	Patient developed extreme pain in both feet, progressing up both legs, extreme headache, depression, episodes of crying,mental confusion, states symptoms lasted 1 week began to subside 11/16/06. Reported symptoms to MD, was seen 11/16/06 referred to neurologist, but did not keep appointment. Patient reported symptoms to family pediatrician, will attempt to/ heal of flu vaccine.										11/07/2006	11/08/2006	1	Patient reports no tests done.	PVT	PVT	NONE	NONE	NONE			1						1	Confusional state; Crying; Depression; Headache; Pain	FLU3~SANOFI PASTEUR~U2243AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267194	11/17/2006	KY	2.0	2	.2	F	11/17/2006	Macular, maculopapular rash all over.  Started on face and went down intermittently.  Started 24 hours after flu shot.  Also flushing of face noted along with it.				Y					Y	11/07/2006	11/08/2006	1		PVT	OTH	Prevacid, vitamins	Rash around mouth for 5 days, comes and goes				1						1	Flushing; Rash macular; Rash maculo-papular	FLU3~SANOFI PASTEUR~UT21765A~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267195	11/17/2006	OR	64.0	64		F	11/17/2006	Patient received injection afternoon of 11/16/06. By 8:30pm eyes were swollen, shortness of breath, stiffness and pain neck and shoulders, nausea, dry mouth and eyes. Patient starting drink more water, used eye drops and inhaler. Eyes are still swollen and some lung irritation on 11/17/06.									N	11/16/2006	11/16/2006	0	NONE	PVT	PVT	Premarin, Flonase, Calcuim, Aspirin, Diovan, Aldactone, Loratadine, Zocor, Albuterol MDI	NONE	hypertension, asthma, transient ischemic attack, hyperlipidemia; allergies: Keflex, Hydrocodone, Levaquin, Asthma, Diazides, Vasotec	flu symptoms~Influenza (Seasonal) (no brand name)~~57.00~In Patient		1						1	Dry eye; Dry mouth; Dyspnoea; Eye swelling; Musculoskeletal stiffness; Nausea; Pain	FLU3~SANOFI PASTEUR~U2250AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267196	11/17/2006	WA	67.0	67		F	11/17/2006	Fainted.  15 minutes later had explosive diarrhea.  Felt weak and went to bed.  On 11/16 had little diarrhea and today feels fine.				Y					Y	11/15/2006	11/15/2006	0		PVT	PUB	multivitamin, aspirin, magnesium	cold for 3 weeks before	allergic to penicillin	5 hours later had a 12 hour flu had diarrhea and nausea~Influenza (Seasonal) (no brand name)~~66.00~In Patient		1						1	Diarrhoea; Syncope	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0267198	11/17/2006	CA	4.0	4		M	11/17/2006	Heart rate 150 at rest 16 hours after vaccines administered. Right arm red, slight induration at site of administration.				Y					Y	11/15/2006	11/16/2006	1	NONE	PVT	UNK		NONE	NONE			1						1	Injection site erythema; Injection site induration; Tachycardia	DTAP~SANOFI PASTEUR~U965AB~5~IM~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2261AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y10302~4~IM~RA~POLIO VIRUS, INACT. (POLIOVAX)~1|MMRV~MERCK & CO. INC.~0830F~2~SC~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0267205	11/17/2006	WI	52.0	52		M	11/17/2006	Received flu shot  10/30/06. On 10/31/06 patient stated about 6 hours after the flu shot his head filled up and had nasal congestion and was stuffed up and had a sore throat. Stated his temp was 101F, took aspirin and rested. Stated his glands on both sides of his throat are swollen and edema has now gone down with only residual tenderness. No other adverse symptoms. States injection site without redness or swelling. Decline offer of throat culture. On 11/1/06, states he is doing better and that he had a throat culture done which was normal.  Stated sore throat was gone and lymph nodes no longer sore.									Y	10/30/2006	10/30/2006	0	NONE	OTH	PVT	Aspirin, Hctz, Lotensin	No ill at vaccination time	No known drug allergies			1						1	Lymphadenopathy; Nasal congestion; Pharyngolaryngeal pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~A71216~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267206	11/17/2006	WI	57.0	57		F	11/17/2006	Flu shot placed 10/26/06. She called on 11/6/2006 to report development of a rash 2-3 days later (10/27 or 10/28) at injection site, which reports was red & pruiritic. States 1 week later, she ate eggs and the rash and pruritis got worse. Developed rash on arms, L abdomen and L back and left upper thigh. General achiness. Not on new meds and is not immunosuppresed. On 11/6/06 rash resolving. Rash appears as nonfluid  filled red circles (largest size=size of a pencil eraser). Denied fever. Per infection control -informed to seek medical care. Not sure if patient has seen a doctor yet.									Y	10/26/2006	10/27/2006	1	NONE	OTH	PVT	Boniva, MVI, Tylenol PRN, Premarin	Recovering from Motor vehicle accident, but doing well.	no egg allergy.			1						1	Erythema; Pain; Rash; Rash pruritic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71216~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267207	11/17/2006	WI	32.0	31		F	11/17/2006	Received flu vaccine 11/1/06 at Employee Health Flu Clinic. Informed Employee Health nurse on 11/6/06 that she noticed a blister on her R upper anterior thigh and some slight redness around it. Reported blister fluid filled. Denied pain, pruitis or any other symptoms. On 11/6/06 patient saw doctor and doctor not concerned. 11/8/06 developed 2 more blisters on her wrists.				Y					Y	11/01/2006	11/05/2006	4	NONE	OTH	PVT	NONE	NONE	Penicillin allergy			1						1	Blister	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71216~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0267172	11/18/2006	NY	40.0	40		F	11/18/2006	Typical soreness at injection site.  Approx 1 hours later rash appeared at injection site and arm. By evening it spread and worsened.  By next day the hives were all over upper body (arms, chest, back, stomach). On Sunday called doctor's office told to take Benadryl and come in morning.  Treatment from Primary Care Physician on Monday was prescription for Methylprednisolone tablets.				Y					Y	11/09/2006	11/09/2006	0	Available from M.D.	UNK	UNK		None	Seasonal Allergies			1						1	Injection site pain; Injection site rash; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72002~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0267173	11/18/2006	GA	32.0	31		F	11/18/2006	WENT TACHYCARDIC, DIZZY AND ALMOST FAINTED, WHICH PRODUCED AND ANXIETY ATTACH. HR 180 BPM, WAS GIVEN 6 ML PUSH ENDOCARD, DID NOT WORK.  THEN WAS GIVEN 12 ML PUSH ENDOCARD WHICH SLIGHTLY HELPED HEARTRATE STABALIZE.  WAS BROUGHT TO ER FOR EKG BLOODWORK AND FURTHER OBSERVATION.  MR received revealing ER visit for anxiety attack and SVT on same day as flu shot. PE WNL except tachycardia and anxiety. Treated with Adenosine in ambulance which converted pt. from SVT to Sinus Tach. In ER given Ativan, Zofran, and KCl. Discharged after several hours. Impression: Anxiety attack, tachycardia, nausea, hypokalemia.			Y	Y					Y	11/17/2006	11/17/2006	0	HEART BLOOD PANEL FOR ENZYMES FOR M/I. (NEGATIVE).  POTASSIUM LOW, WAS GIVEN POTASSIUM PILLS. Labs and Diagnostics: EKG reveals sinus tachycardia @ 128BPM, BMP significant for K+ of 2.7, Co2 of 19 and glucose of 136. Cardiac enzymes WNL. CBC significant for WBCs of 15.6.  CXR-normal.	UNK	UNK	ALAVERT, NASACORT AQ, PEPCID	NONE	SVT, ANXIETY DISORDER PMH: Anxiety, SVT.   Allergies: PCN.			1						1	Anxiety; Blood glucose increased; Carbon dioxide decreased; Dizziness; Hypokalaemia; Nausea; Supraventricular tachycardia; Tachycardia; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0267174	11/18/2006	SC	0.0			F	11/18/2006	Patient states she had a severe reaction starting 2 days after the flu vaccine(given 11-4-06). Patient states having fever of 100.9 , severe pain, shooting pains all over her body including right leg, left arm, chest , head and ear. Patient reports a diagnosis of cellulitis in elbow with Keflex given by 1 of the 2 doctors she saw. Patient is still undergoing treatment at this time.				Y					U	11/04/2006	11/06/2006	2		UNK	UNK			Diabetes and Hepatitis C---information relayed to immunizer after getting vaccine			1						1	Cellulitis; Chest pain; Ear pain; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F600911~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0267175	11/18/2006	IN	35.0	35		F	11/18/2006	I (patient) broke out in itchy hives, extremities became swollen, experienced dizziness, feverish, had diarrhea, experienced slight difficulty breathing.  I took Claritin, but that didn't help.  I then took Benedryl and that did help.  However, my work took one look at me and told me to go to the doctor.  She took a swab for strep (she said it could be scarlet fever - even though I didn't have any white dots in my throat nor did I have a high fever), but that test came back negative.  The hives have gone away (48 hrs later) and now I'm just left feeling dizzy, nauseated, diarrhea, and have a rash.				Y					Y	11/16/2006	11/16/2006	0	Doctor performed a strep test to rule out strep.  Test came back negative.	UNK	UNK		NONE				1						1	Diarrhoea; Dizziness; Dyspnoea; Oedema peripheral; Pruritus; Pyrexia; Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~~5~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0267179	11/19/2006	AZ	37.0	37		M	11/19/2006	High fever 2 days Severe headache 2 days Diarrhea 1 day Nauseous 2 day Vomiting 2 days									Y	11/18/2006	11/18/2006	0		MIL	OTH	None	None	None			1						1	Diarrhoea; Headache; Nausea; Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500440P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0267180	11/19/2006	CA	54.0	54		F	11/19/2006	Within 6 hours of the injection, chills and shivering, sweats, general weakness and inability to stand.  Stayed in bed for the entire day after the injection.									Y	11/16/2006	11/16/2006	0	None	UNK	UNK	none	none	diverticulosis. no allergies, defects, no prescription medications			1						1	Asthenia; Chills; Hyperhidrosis; Hypokinesia	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0267181	11/19/2006	PA	66.0	66		F	11/19/2006	ITP: petechial rash all over body, including over site of vaccine administration; blood clot in mouth, epistaxis, platelet count of 1100, events started 18 hours after administration of influenza vaccine (fluarix); symptoms improved with administration of steroids and IVIG in hospital, patient was discharged 6 days after admission with increased platelet count to 70,000 after treatment and had no further bleeding/petechiae after administration to hospital and treatment.  1/9/07 Received medical records from hospital which reveal patient admitted 10/31/06-11/6/06 with bleeding.  Had red bumps on legs, arms, trunk & back for 2 days prior to admit after received flu shot on day bumps began.  Also had a bloody nose & saw PCP who obtained labs which revealed plts of 1100 & patient sent for admit.  Exam in ER revealed positive blood clot in left buccal mucosa, positive petechiae in upper palate, under tongue, bilateral extremities & back.  Slight tender cervical LAD.  Received steroids & IVIG in ER after heme consult.  Slowly improved & d/c to home on tapering steroids & heme clinic follow up.  FINAL DX: Idiopathic thrombocytopenia.					Y	6			Y	10/28/2006	10/29/2006	1	Platelet count: 1,100 (improved to 70,000 with treatment) LABS: Admit labs: Hgb 13.6, plts 1000, fibrogen 356, DDimer 0.57, PT 12.9, INR 0.97, PTT 27 & smear showed marked thrombocytopenia.  D/C labs: plts 70,000. US of abd 11/2 revealed spleen size WNL.	UNK	UNK	Aspirin: 81 mg Premarin Centrum Silver	none	Retinal Detachment (Right eye)			1						1	Epistaxis; Petechiae; Platelet count decreased; Thrombosis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA234AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0267182	11/19/2006	LA	44.0	44		F	11/19/2006	I had a flu shot Oct. 2, after that for the next couple of weeks, I experienced numbing and tingling in my left arms from my fingertips to my shoulderblade, I dismissed it as an 'aftereffect' of the shot. Week three went by, I went to the PCP, described the problems, She put me on Naprosyn and Neurontin, which only masked the problems, as the numbing and tingling were still there. Week four, I started having motor problems, dropping cups and plates, etc. I went to an orthopedic, everything was normal, including xray of my neck. So, onto neurologist who did a nerve conductivity test that turned out normal. . Week 5 included PAIN, and increasing into the shoulder blade. I had a full exam with the neurologist (week 6) . He has ordered Brain MRA's and C-Spine MRI tests, which are scheduled for this wed (nov.  22ndth) I have a physical therapy evaluation Tomorrow (Monday , Nov. 20th..   The neurologist seems to think the symptoms are MS- like and conclude it was probably from the flu shot.   I took blood tests today, Including SED Rate, ANA, C React Protein, and an RA test.									U	10/02/2006	10/03/2006	1	Orthopedic never conductivity test = normal  xrays of my neck = normal	UNK	UNK	None	None	none			1						1	Hypoaesthesia; Hypokinesia; Paraesthesia; Shoulder pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0267183	11/19/2006	TX	65.0	65		M	11/19/2006	Dizzyness for 45 minutes to an hour. Almost blacked out.									Y	11/18/2006	11/18/2006	0		UNK	UNK		none				1						1	Dizziness	FLU3~SANOFI PASTEUR~~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0266673	11/20/2006	IA	32.0	32		F	11/14/2006	Initial information received on 11/13/06 from a health care professional. A 32 year old female pt received a dose of Fluzone no preservative 2006-2007, lot number U2165DA, administered in the deltoid on 10/24/06, Within 24 hours of administration, on 10/25/06, the pt developed hives, which progressed to generalized welts, then swelling and inflammation from the waist down. The inflammation then moved up to her chest and face. She was seen in the ER on 10/24/06 and 10/28/06. She was admitted to the hospital on 10/28/06. It was reported that her reaction included organ impact, but no specific information was provided. The pt was discharged from the hospital on 11/3/06. At the time of this report she had not recovered from the events and was unable to return to work. The reporter considered the events to be life threatening. The pts past medical history is significant for unspecified reaction following immunization with influenza vaccine in 2004, while taking steroids. She also had an unspecified reaction after receiving an influenza vaccine in 2005, while taking antibiotics. The trade names, lot numbers and manufacturers were not reported for either of the previous influenza vaccines.			Y		Y	7			N	10/24/2006	10/25/2006	1		UNK	UNK					200603074	1						2	Anxiety; Hyperglycaemia; Hypersensitivity; Inflammation; Leukocytosis; Swelling; Swelling face; Urticaria; Vaccination complication; Inflammation; Oedema; Urticaria	FLU3~SANOFI PASTEUR~U2165DA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2165DA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0267188	11/20/2006	OH	78.0	77		F	11/18/2006	Within minutes of receiving vaccine, pt complained of Nausea, proceeded to loss consciousness. Paramedics were called vitals were monitored and were normal, once Paramedics arrived pt gained consciousness. At hospital pt was diagnosed with anemia and incident was not related to vaccine.  11/30/06 Received medical records from hospital which reveal patient admitted 11/15/06 & d/c to home 11/17/06.  Had vasovagal syncope & was admitted to telemetry to r/o cardia arrhythmia. Also had complaints of abdominal pain for about 1 week prior to admit with diarrhea & black stools.  GI consult & EGD done & received transfusion x 1. PMH: rheumatoid arthritis, NIDDM, HTN Final DX: anemia, hiatal hernia, gastritis/ss				Y	Y	3			Y	11/15/2006	11/15/2006	0	Pt diagnosed with anemia. LABS: H/H on admit 8.4/25.71.  H/H on D/c was 11.1/31.5	OTH	PVT	NONE	Diagnosed with anemia.				1						1	Anaemia; Haematocrit decreased; Haemoglobin decreased; Loss of consciousness; Nausea; Syncope; Syncope vasovagal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA232CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0267199	11/20/2006	KY	51.0	50		F	11/18/2006	Pt is a 51 yo f who presented to pharmacy to receive both the pneumococcal and influenza vaccines. Pt then experienced some swelling in one of her arms, but the pharmacy was unable to verify which arm. Pt received Influenza vaccine in left deltoid and the Pneumovax vaccine in the right deltoid.				Y					U	11/16/2006	11/16/2006	0		OTH	PVT		Preventive	None reported			1						1	Swelling	FLU3~SANOFI PASTEUR~U2180AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0885F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0267200	11/20/2006	TX	20.0	50		F	11/12/1956	On day of the injection I felt sore on the fifth day. I developed a blister									U	11/07/2006	11/12/2006	5		OTH	OTH						1						1	Blister	FLU3~SANOFI PASTEUR~U2160AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267201	11/20/2006	CO	5.0	5		M	11/17/2006	About 7 minutes after administration of Flu shot pt presented with hives on his face only. Treated with Benadryl 12.5/5 ml, 5ml PO now. Hives decreased within 10-20 minutes. Before admin of IZ, grandmother asked if egg allergy and stated no. When explained after reaction, Grandmother states she recalls now that patient gets hives when he eats eggs.										11/17/2006	11/17/2006	0	NONE	OTH	OTH	Albuterol; Flovent 110 mg	Mild upper respiratory infection				1						1	Urticaria	FLU3~SANOFI PASTEUR~U2286AA~5~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267202	11/20/2006	IA	0.58	0	.6	M	11/17/2006	See attached ER sheet				Y					Y	11/16/2006	11/16/2006	0		PVT	PVT	Amox	Cough and runny nose				1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2196AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267203	11/20/2006	WI	7.0	7		M	11/17/2006	7 year old male presented to clinic on 11/17/06 with an active case of varicella. Pt treated with Benadryl 12.5/5 1 tsp given 4-6 h prn. Lesions began 2-3 days prior to presentation at clinic.									U	11/10/2006	11/16/2006	6	NONE	PUB	PUB	NONE	NONE	Amoxicillin Allergy			1						1	Skin ulcer; Viral infection	FLU3~SANOFI PASTEUR~U2196AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1050F~2~~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0267204	11/20/2006	MN		64		F	11/17/2006	The patient had a red itchy rash around site of injection and down the arm.									Y	11/15/2006	11/16/2006	1		OTH	PVT		NONE				1						1	Injection site erythema; Rash pruritic	FLU3~SANOFI PASTEUR~U2279AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267276	11/20/2006	IL	64.0			F	11/14/2006	Seriousness criteria other medically significant (OMIC). Initial report received on 1/9/06 from the pt. A 64 year old male pt, with no concurrent illnesses, know allergies, or reported medical history, but who was taking Atacand, had received a right deltoid dose of Influenza vaccine, lot number unk, in either Nov or Dec 2005. The route of administration was not reported. Twenty four hours post immunization, the pt developed a reddened area that scabbed and then turned red (site not reported). He was recently evaluated by a dermatologist who diagnosed him with skin cancer. He also recently had a biopsy done. The result of the biopsy was not reported. Diagnostics performed and treatments received were not reported. At the time of this report, the pts recovery status was unk.				Y					U					PVT	PVT	ATADAND				200603020	1						1	Erythema; Neoplasm malignant; Skin disorder	FLU3~SANOFI PASTEUR~~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267281	11/20/2006	TX	7.0	7		M		A report was received of asthma coincident to FluMist therapy. A seven year old with a history of one episode of croup at the age of five and multiple episodes of bronchitis in the past 12 months, received FluMist on 10/10/06. On 11/1/06, the pt was admitted to the hospital with an acute asthma event and remained hospitalized for three days. The pt had no previous diagnosis of asthma. Information regarding hospitalization, treatment, and event outcome were not provided. The reporter did not provide a statement of causality to FluMist. DOS 11/01-11/03/2006 DC DX: Status Asthmaticus, resolved. Hypoxia, resolved and Bronchitis. Presented to PCP with first asthmas attck on 11/1/06. Responded to nebulizer treatment with Xopenex. Sent home, subsequently developed more wheezing and difficulty breathing , sent to facility. On admission significantly dyspeneic. Required oxygen to keep satus above 95%, quite winded with wheezing and subcostal retraction. Started on Xopenex and Atrovent. Pulmicort nebs. Gradually weaned off oxygen. Continue nebulizer treatments at home. Per annual follow up report: Reporter indicated that the patient had finally recovered from the event, 07-Mar-2008.					Y	2			Y	10/10/2006	11/01/2006	22	CXR: findings consistent with bronchospasm.  Labs: neut % 83.2, lymph %8.0, Neut # 9.1, Lymph #0.9, Seg % 78, Band %10 and Lymph%5. Potassium 3.4, Glucose 146, Calcium 11.0.	OTH	OTH	Concomitant Drug(s) Not reported		Croup, bronchitis.		MEDI0005109	1						1	Asthma; Laboratory test abnormal; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500433P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0267292	11/20/2006	PA	1.3	1	.3	F	11/14/2006	See attached info 02/22/07-records received adn reviewed for DOS 10/26-11/10/06 DC DX: new onset seizure disorder possible hypoxic encephalopathy possible encephalitis pancreatitis developmental regression visual cortical impairment Hospital course:experienced right sided seizure lasting approximately 45-60 minutes with possibly hypoxia during that time. Subsequent seizure on 10/30/06 required intubation and extubated on 11/3/06.   11/4/06 developed persistent right gaze and right tracking and hypertonic symptoms. Multiple myoclonic jerks were noted.  Continued to have diffuse truncal hypotonia. Persistent left ankle hypertonic extension. Per 60 day follow up: Still with global developmental delay. Can get lot # from her PCP. I took care of her during her rehab admission.			Y	Y	Y	14	Y	Y	N	10/18/2006	10/26/2006	8	Elevated lipase 1618. LP negative  CSF culture, HSV, PCR, CMV and enteroviral PCR negative. Respiratory and blood culture negative. EEG:diffuse slowing with left hemisphere specific slowing.  MRI bilateral cortical injury versus ischemia with diagnosis of hypoxemic encephalopathy. Abnormal diffusion in white matter. CT Head:questionable abnormality involving right high parietal region acute ischemia cannot be totally excluded. Repeat EEG noted no change in seizure foci showing only diffuse slowing.	PVT	UNK						1						1	Blood culture negative; Computerised tomogram abnormal; Laboratory test; Lumbar puncture normal	FLU3~SANOFI PASTEUR~u2204aa~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0700f~2~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~b08653b~5~~RA~PNEUMO (PREVNAR)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0267294	11/20/2006	MD	51.0	51		F	11/20/2006	Left arm pain in upper area since shot continues today. No pain at rest but noticed with arm movement.									U	11/06/2006	11/06/2006	0	Physical assessment by MD	PUB	PVT	Advair, Synthroid	NONE	Sarcoidosis, hypothyroidism			1						1	Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71643~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267295	11/20/2006	WI	16.0	15		M	11/16/2006	Lymph node swollen under right clavicle less than 48 hours after immunization, supra clavicular space. Resolved by 11/20.									Y	11/13/2006	11/15/2006	2		PVT	PVT						1						1	Lymphadenopathy	FLU3~SANOFI PASTEUR~U2212AA~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267297	11/20/2006	CO	15.0	14		F	11/12/2006	Unk pt was given Fluarix in error should have been Fluzone.									U	11/12/2006				OTH	OTH		NONE	NONE			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA206BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0267298	11/20/2006	CA	17.0	16		F	11/12/2006	Unk pt was given Fluarix in error should have been Fluzone									U	11/12/2006				OTH	OTH		NONE	NONE			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA206BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0267299	11/20/2006	CO	11.0	11		M	11/12/2006	Unk pt was given Fluarix in error should have been preservative free Fluzone.									U	11/12/2006				OTH	OTH	UNK	NONE	UNK			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA206BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0267300	11/20/2006	VT	60.0	60		F	11/15/2006	Pt received 2 influenza shots 5 days apart. No adverse symptoms, signs. 1st shot received 11/8/06 during home care visit. 2nd flu shot given 11/13/06 instead of Pneumonia shot, as had been planned. Vaccine was prepared by this writer and administered by home care RN. Error noted 11/14/06. Pt received Pneumonia shot next visit.									Y	11/13/2006	11/14/2006	1		OTH	PVT		Post joint replacement 10/23/06				1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601511~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0267301	11/20/2006	CA	38.0	37		M		15 minutes after flu shot I was on the freeway when I started to get a weird feeling. I was hot and sweating, breathing hard, felt like I was going to pass out, vision was darkened, lips and face were pale.									Y	11/07/2006	11/07/2006	0		PVT	UNK		NONE	NONE			1						1	Dizziness; Dyspnoea; Feeling abnormal; Hot flush; Hyperhidrosis; Pallor; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0267302	11/20/2006	MO	55.0	55		M	10/26/2006	Severe chills, fever 101F, aching, headache, approx 12 hours after getting vaccine, no local reaction at the injection site. Employee states much better 24 hours later temp 99 24 hours later.									Y	10/24/2006	10/24/2006	0		OTH	PVT	NONE	NONE	NONE			1						1	Chills; Headache; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71355~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267303	11/20/2006	UT	28.0	27		F	11/10/2006	Rash started developing under neck Saturday 11/04/06 at about seven pm, by 11/8/06 it had become more severe and pt had developed a fever. Pt went to MD on 11/9/06 and was DX with cellulitis. Dr prescribed Keflex 500mg T BID 10D. Dr stated that he believed the condition to have been caused by the influenza vaccine.									U	11/02/2006	11/04/2006	2		OTH	PVT						1						1	Cellulitis; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U2193AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267304	11/20/2006	MN	32.0	32		F	11/13/2006	Chest tightness, tickly cough, red and burning eyes, congested ears 1 1/2 hrs after injection.				Y					Y	10/23/2006	10/23/2006	0	Egg white rash, CBC	PUB	OTH		NONE	Childhood asthma, heart murmur.			1						1	Chest discomfort; Cough; Ear disorder; Eye inflammation; Nasal congestion; Ocular hyperaemia; Rash	FLU3~SANOFI PASTEUR~U2257AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267306	11/20/2006	IN	50.0			F	11/11/2006	Light headed and weak, head tingling feel like something moving in my head, blood pressure went up high. Still not study up and down.				Y					N				Acute Headache post vaccination cephalgia.	PUB	UNK			High blood pressure			1						1	Asthenia; Dizziness; Head discomfort; Headache; Hypertension; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0267307	11/20/2006	IL	12.0	12		F	11/10/2006	48 hours after flu mist onset with fatigue, rhinorrhea, red eyes, conjunctivitis.									U	11/01/2006	11/03/2006	2	CBC WNL	PVT	UNK		Recent OMC with rupture eardrum on 10/24/06.				1						1	Conjunctivitis; Fatigue; Ocular hyperaemia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500434P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0267308	11/20/2006	FL	10.0	10		F	11/10/2006	11/08/2006 evening area around injection sites became blotchy, red, raised, (hives like about size of dime) covered left upper arm 2.3 of way toward elbow, inner and outer aspect of upper arm left. Benadryl 25 mg PO Q 6 hours. 11/13/06 per mom resolved except tiny bump size of pencil eraser.									Y	11/07/2006	11/08/2006	1	NONE	PVT	PVT	NONE	NONE	Amoxicillin Allergy 12/30/00			1						1	Injection site erythema; Injection site mass; Injection site swelling; Rash macular; Urticaria	FLU3~SANOFI PASTEUR~U2248AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0485F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267309	11/20/2006	MI	51.0	51		F	11/15/2006	Received vaccine 10/27/06 on 11/08 c/o severe muscle aches and bone pain generalized. Experienced pain when touching face. Difficulty to move, felt bad for approx 30 hours took no meds. Pain gradually diminished on 11/10/06 developed hives on arm and torso, takes Benadryl and hives gone on 11/11/06, cannot identify anything new or used that would cause hives.									Y	10/27/2006	11/08/2006	12		PUB	PVT	Actose, Lotrel	NONE	NONE			1						1	Bone pain; Malaise; Myalgia; Pain; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA220AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0267311	11/20/2006	TX	23.0	23		F	10/24/2006	Severe Pain radiating down the arm for a period of three days followed by aching pain in shoulder over the next 3-4 days.										10/12/2006	10/12/2006	0		OTH	OTH	NONE	NONE	NONE			1						1	Pain; Shoulder pain	FLU3~SANOFI PASTEUR~U2257AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267312	11/20/2006	TX	32.0	32		M	10/24/2006	Sore under left arm pit and knotty.									U	10/13/2006	10/13/2006	0		PUB	PUB	Hydrocodone, Pnenergan.	NONE	NONE			1						1	Pain; Skin nodule	FLU3~SANOFI PASTEUR~U2257AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267314	11/20/2006	CA	1.69	1	.7	M	11/15/2006	Red, warm local surrounding Dtap injection site.				Y					Y	11/14/2006	11/15/2006	1		PVT	PVT						1						1	Injection site erythema; Injection site reaction; Injection site warmth	DTAP~GLAXOSMITHKLINE BIOLOGICALS~ACK1B040BA~UNK~~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UB220BB~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHABVV9BA~1~~LL~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~0910F~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0267317	11/20/2006	MN	2.0	2	.2	M	11/10/2006	NONE										11/06/2006				PVT	PVT						1						1	Unevaluable event	FLU3~EVANS VACCINES~71210~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267318	11/20/2006	TX	48.0	48		F	11/02/2006	Right deltoid swollen and blotchy. Tenderness at injection site.									Y	11/01/2006	11/01/2006	0		PVT	OTH	NONE	NONE	NONE			1						1	Injection site pain; Injection site swelling; Rash macular	FLU3~SANOFI PASTEUR~U2239AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1005F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267320	11/20/2006	MO	3.0	3		M	11/20/2006	Left upper thigh with redness; no induration. Treated with Duricef oral antibiotics.				Y					Y	10/31/2006	11/01/2006	1		UNK	PVT						1						1	Erythema	FLU3~SANOFI PASTEUR~U2165BB~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1008F~1~IM~LL~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0267321	11/20/2006	TX	46.0	46		F	11/01/2006	Within 30 minutes developed localized pain and swelling. Was warm to touch. Developed generalized itching and headache 1.5 hours later.									Y	10/31/2006	10/31/2006	0	NONE	PUB	PUB		NONE	Seasonal and food allergies (no known egg allergies).		TX06075	1						1	Headache; Injection site warmth; Pain; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U2245AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267323	11/20/2006	OH	50.0	50		M		Body aches, chills, fever, sore throat.									Y	11/01/2006	11/01/2006	0		OTH	PVT		None				1						1	Chills; Pain; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U2189AA~UNK~SC~AR~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267324	11/20/2006	OH	47.0	47		M	11/14/2006	Sore throat, aches, pains/flu like symptoms, chills.									Y	11/01/2006	11/01/2006	0		OTH	PVT	NONE	NONE				1						1	Chills; Influenza like illness; Pain; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U2189AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267325	11/20/2006	OH		57		F	11/08/2006	11/1 Received shot - had chills evening and during night. Headache following day. Felt fine by Friday 11/3.									Y	11/01/2006	11/01/2006	0		OTH	PVT	NONE	NONE				1						1	Chills; Headache	FLU3~SANOFI PASTEUR~U2189AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267326	11/20/2006	OH	79.0			M	11/08/2006	PM of vaccine, horrible chills all PM. All day the following day, aches and pains, headache. By Friday PM, all symptoms gone.									Y	11/01/2006	11/01/2006	0		OTH	PVT	Lipitor	NONE				1						1	Chills; Headache; Pain	FLU3~SANOFI PASTEUR~U2189AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267327	11/20/2006	OH	74.0	74		F	11/08/2006	11/1 vaccine was administered. That evening started chills - was in bed with aches, pains in joints and headache. All symptoms gone by Friday PM.									Y	11/01/2006	11/01/2006	0		OTH	PVT	NONE	NONE				1						1	Arthralgia; Chills; Headache; Pain	FLU3~SANOFI PASTEUR~U2189AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267328	11/20/2006	OH	51.0	51		F	11/15/2006	Heart racing; shortness of breath; tightness of chest; seeing black spots in my line of vision.				Y					Y	11/07/2006	11/07/2006	0	EKG; CT; BMP; CBC; D-Dimer; CK	PVT	UNK						1						1	Chest discomfort; Dyspnoea; Heart rate increased; Visual disturbance	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA218BA~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0267329	11/20/2006	NC	7.0	7		M	11/16/2006	7 year old male received an influenza vaccine in the right upper extremity today. Within 30 minutes of the injection his mother noticed that he complained of right arm pain and began crying. He became somewhat upset and anxious. His mother thought she noted a rash around his eyes. She did not notice a rash on the trunk. The child complained of difficulty breathing briefly. The mother noted no cyanosis or altered state of consciousness. No nausea, vomiting, or fever. She called the office and was advised to give a dose of Benadryl and return for reevaluation immediately. She presented within 30 to 45 minutes of this phone call.									N	11/14/2006	11/14/2006	0	NONE	PVT	PUB	QVAR; Albuterol; Xopenex; Singulair		Chronic persistent asthma; History of migraine headaches	Questionable reaction to oral polio~Polio Virus, Oral (no brand name)~~0.00~In Sibling		1						1	Anxiety; Crying; Dyspnoea; Pain; Rash	FLU3~SANOFI PASTEUR~U2187AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267348	11/20/2006		38.0	38		F	11/20/2006	Injection at 1700 of influenza virus vaccine Fluzone.  Complained of lightheadedness, tingly all over, feet feel numb, and face feels numb, began about 15 seconds after injection.  Had similar reaction to 3rd anthrax injection.  No food/medicine allergies.  Currently is recovering from cold/flu.									Y	11/20/2006	11/20/2006	0	none	MIL	MIL	vitamin, Seasonale, Wellbutrin, acyclovir, Sudafed, Tylenol, Claritin, guaifenesin	upper respiratory tract infection, taking chronic acyclovir for herpes, depression	no food/drug allergies.			1						1	Dizziness; Paraesthesia	FLU3~SANOFI PASTEUR~U2199AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267351	11/20/2006	KY	52.0	52		F	10/19/2006	Site-Red, itching, swollen, hand swelling tight feeling, aching-red, lips swollen-itching   Pt. states she took Benadryl and symptoms were better this morning when she go up.									Y	10/18/2006	10/18/2006	0		UNK	UNK	K+ Manzide Allegra nexum provera	small amount of congestion	Sulfa-asthma slight		KY2006039	1						1	Face oedema; Injection site erythema; Injection site hypersensitivity; Oedema peripheral; Pruritus	FLU3~SANOFI PASTEUR~U2239AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267353	11/20/2006	MN	45.0	45		F	11/20/2006	11-16-06 At about 1800, noted a scratchy throat & runny nose, shoulder aches,and general malaise, no fever, felt nauseated. 11-17-06 Cont. symptoms, noted nasal mucus very sticky and stringy. Increased nasal drainage and productive coughing with clear mucus. 11-20-06 Today feels improving.									Y	11/14/2006	11/16/2006	2		UNK	UNK	Advair and estrogen	none	mild asthma	Carolyn~Pneumo (no brand name)~2~0.00~In Patient		1						1	Cough; Malaise; Nausea; Pharyngolaryngeal pain; Rhinorrhoea; Shoulder pain	FLUN3~MEDIMMUNE VACCINES, INC.~500439P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0267354	11/20/2006	KY	55.0	55		F	10/26/2006	In less than 15 min pain in shoulders, moved to other shoulder, 10/25/06 weak and hurt in shoulders and arm all day, missed work- use ice/heat- motrin.									Y	10/24/2006	10/24/2006	0	na	UNK	UNK	trazadon, zoloft, klorice, accuprel, glyvuride zyrtec, trichecr, previce, metafcrmxin, Indapanche	none	diabetic, increase B/P, glacoma fibromyalgia arthretes burcystis		KY2006041	1						1	Asthenia; Shoulder pain	FLU3~SANOFI PASTEUR~U2239AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267355	11/20/2006	AZ	9.0	9		F	11/09/2006	11/9/06 10:32 First time flu vaccine observation, c/o dizzy; 10:45 c/o SOB SaO2 96%, HR 88; 10:55 c/o itchy & HA Benadryl 25mg po, acetominophen 325 mg po, Temp 99.0, SaO2 95%, HR 98, RR 24; 12:35 Released to school.									Y	11/09/2006	11/09/2006	0		UNK	UNK			NKDA			1						1	Dizziness; Dyspnoea; Pyrexia	FLU3~SANOFI PASTEUR~U2271AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267356	11/20/2006	OH	39.0	39		F	11/02/2006	Rec'd vaccine at 1330. At 1800 site became red, warm to touch, swollen and sore, stated BP 11/01/06 was up 157/93, 11/02/06 site red warm and swollen at 1 3/4 inches round.									Y	10/31/2006	10/31/2006	0	n/a	UNK	UNK	cymbalta, ambien, other-novium, motrin	none	fibromyalgia		KY2006042	1						1	Blood pressure increased; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2242AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267357	11/20/2006	AZ	12.0	12		F	11/09/2006	10:11 c/o SOB SaO2 98%, HR 98, Right arm injection site red/warm cold pack applied, Benadryl 25 mg po; 10:16 SaO2 97%, HR 98; 11:15 Pt verbalizes feeling okay; 11:25 SaO2 95% HR 72 sleeping easily aroused s/s resolved; 12:45 Released. MD Release Okay.									Y	11/09/2006	11/09/2006	0		UNK	UNK			NKDA			1						1	Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U2271AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267358	11/20/2006	MI	35.0	35		F	11/20/2006	3 days after receiving influenza vaccination, noted total body itching without rash present. 4 days after receiving influenza vaccination sought medical treatment and Zyrtec 10 mg, 1 po daily was prescribed.				Y					U	11/13/2006	11/16/2006	3		UNK	UNK	Zelnorm	IBS				1						1	Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70740~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0267359	11/20/2006	AZ	12.0	12		F	11/09/2006	11:42 Pt states Hurt where I got shot, feel faint c/o SIB, Benadryl 25 mg po, Acetominophen 325 mg po; 12:16 Nauseous (vomited).									Y	11/09/2006	11/09/2006	0		UNK	UNK			NKDA			1						1	Dizziness; Dyspnoea; Nausea; Pain; Vomiting	FLU3~SANOFI PASTEUR~U2271AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267361	11/20/2006	OH	46.0	46		F	10/27/2006	Redness and heat at injection sited and noted 24 hours after injection.  Area approx 6cmx6cm, no other s&s.  To follow up with family doctor to rule out allergy and poss txn r/t latex allergy.									Y	10/26/2006	10/27/2006	1	n/a	UNK	UNK		no	Latex allergy newly diagnosed		KY2006044	1						1	Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U2242AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267362	11/20/2006	IL	2.0	2	.2	F	11/20/2006	27 month old child rec'd incorrect dose of vaccine. Rec'd 0.5 ml Fluzone, should have gotten 0.25 ml.  11/20/06 follow up call to parent no adverse effect from vaccine.									Y	11/18/2006	11/18/2006	0		UNK	UNK	none	none	none			1						1	Medication error	FLU3~SANOFI PASTEUR~U22u5AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267363	11/20/2006	CT	34.0	34		F	11/20/2006	10/30/06 Vaccine administered at 10:05 am. at work. Patient developed a rash and was itchy approximately 20 minutes after vaccine administered.  Area of rash face, torso, hands, legs. RN examined her and recommended patient see her physician.  Patient saw her private physician at 12:20.  She reported difficulty breathing and MD did a nebulizer treatment.   On 10/31/06 she reported a fever of 102 On 11/1/06 patient returned to work and reported that she was achy and had a headache.				Y					Y	10/30/2006	10/30/2006	0		UNK	UNK			Asthma			1						1	Headache; Pruritus; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U2244AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267366	11/20/2006	MO	51.0	51		M	11/20/2006	High fever beginning approx. 8 hours after receiving the vaccine and lasted for about 6 hours.  A low-grade fever lasted another 24 hours.  Developed a quarter-size blistery rash on the left cheekbone on the next day after the shot was administered.  Area is still red but nearly healed up.									Y	11/07/2006	11/07/2006	0		UNK	UNK						1						1	Blister; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267368	11/20/2006	OH	80.0	80		F	11/20/2006	within 24 hours of (unknown brand) influenza vaccination, my mom felt weak and dizzy - very weird most of day - she just made it to the next room to a chair and would have fallen to the floor but the chair broke her fall - she spun the easy chair completely around, did not pass out by would have fallen she was so dizzy. I do not know which specific flu shot she got.									Y	11/14/2006	11/15/2006	1		UNK	UNK	none	none	none			1						1	Asthenia; Dizziness; Malaise	FLU3~SANOFI PASTEUR~~UNK~ID~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267369	11/20/2006	NY	34.0	34		F	11/20/2006	Tightness of chest, wheezing, coughing, tightness and burning in throat 4 hours after shot.  Took 1 benadryl.  Throat relaxed, chest still tight, took another benadryl 1 hour later.  Severe aches, and chills set in.  Took 2 motrin and went to bed with 3 blankets on at 10:00pm.   Woke up next morning at 9:00 AM felt better.  Just had headache, and joint and back aches.  Chest still a little wheezy.  Took 1 benadryl.  Symptoms went away by 5:00 pm.									Y	10/18/2006	10/18/2006	0	none- phone call to doctor.  Meds self administered.	UNK	UNK	levithroid, 100mcgs/1xday	none	allergic to sulfa drugs, morphine.   hypo-thyroidism.  Breast cancer in 1986, no chemo., no radiation.  Mastectomy			1						1	Arthralgia; Back pain; Chest discomfort; Chills; Cough; Headache; Pain; Pharyngolaryngeal pain; Wheezing	FLU3~SANOFI PASTEUR~u2184aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267371	11/20/2006	IA	58.0	58		F	11/20/2006	Vaccine leaked from syringe upon injecting intramuscularly into deltoid muscle and landed in patient's eye.  Rinsed eye with lubricating eye drops and notified patient's personal physician and physician with whom Hy-Vee has collaborating protocol.  Also contacted Poison Control Center and Vaccine manufacturer for additional info.									Y	11/19/2006	11/19/2006	0		UNK	UNK	Prevacid, Benazepril	None				1						1	Medication error	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71642~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267375	11/20/2006	TX	34.0	34		F	11/20/2006	About 15-20 minutes after receiving the flumist I felt very drowsy and could barely stay awake.  I also was very disoriented and literally walked into a wall after going through a doorway.  A few minutes after that I rose from sitting and nearly fell over.  I felt similar to if I was very inebriated for several hours and was afraid to drive until much later that evening.									Y	10/19/2006	10/19/2006	0		UNK	UNK		none	none			1						1	Disorientation; Somnolence	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0267377	11/20/2006	WA	62.0	62		F	11/20/2006	Patient called our pharmacy 11/20/06 @215pm and reported that she got sick four days later from receiving a flu vaccine on 11/7. She experienced rash, sore throat, soreness and swelling on tounge. She also reported that her throat closed up. She said she went to the ER and had to take several days off work. She is now stable.			Y	Y	Y				Y	11/07/2006	11/11/2006	4		UNK	UNK		None				1						1	Pain; Pharyngolaryngeal pain; Rash; Throat tightness; Tongue oedema	FLU3~SANOFI PASTEUR~A2240AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0267378	11/20/2006	VA	66.0	66		F	11/20/2006	Shot in left arm on Nov. 13th 2006; reactioncame as surprise I expected only a sore arm. Came home---- about 2 hours after shot felt like I had the flu -----muscles in whole body hurting----temperature went up about 1.5 degrees.  Called Doctor at pharmacy ---said to take tylenol and that I would feel better in about 2 days.   Severe muscle pain and fatigue-weakness like flu; congestion; cough; headache; had to go to bed  couldn't stay up.     Had no choice but to go to bed--------pushed all of the liquids I could to stay hydrated and cleanse my sytem.  Muscle pain was better on Wed. morning but not the congestion and coughing and the fatigue.   Literature says it takes 2 weeks for full immunity so don't know whether this reaction will last longer and to what extent.  Note the time of the vaccine I entered is approximate.  Was late afternoon about 5:00 p.m.									U	11/13/2006	11/13/2006	0	See the note in number 7 which gives the manufacturer and lab info on the vaccine----this form does not allow for that to be input.	UNK	UNK	Estratest once a day execedrin occassional b-12 injection once a week started lexapro 5 milligram about 3 weeks ago	No identifiable major illness	Environmental allergies, erythromycin allergy  Had rheumatic fever as a child  Had mono in 2000  Hysterectomy in 1985			1						1	Cough; Fatigue; Headache; Myalgia; Nasal congestion; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0267379	11/20/2006	OR	72.0	72		F	11/20/2006	pt. c/o alternating chills and fever, SOB and wheezing noted when he has chills, some N/V-symptoms started a couple days after receiving flu vaccine on 11/3/06.  Rocephin injection given on 11/7/06 labs, blood cultures, urine and chest xray checked.									Y	11/03/2006	11/07/2006	4	blood cultures, urinalysis, chest xray, CMP, CBC	UNK	UNK	Viagra Aspirin Lisinopril Hydrochlorothiazide	none noted	no allergies medical list:  COPD, HTN, Diverticulosis, restrictive lung disease			1						1	Chills; Dyspnoea; Nausea; Pyrexia; Vomiting; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA222BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0267394	11/20/2006	CA	79.0	79		F	11/20/2006	11:30 am 11/17/06 pt reported pain at left deltoid shooting down left arm, no redness, swelling, induration noted. No resp distress observed. 11:40 am left message Dr office stated will give message to Dr when he calls 12:30 pm 11/20/06 spoke to pt by phone arm feels much better and every day getting better. Has been applying ice to arm per Drs instruction, states he called her on Friday.									Y	11/17/2006	11/17/2006	0	NONE	PUB	PUB	UNK	NONE	Osteoporosis.			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U2251AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267395	11/20/2006	CO	31.0	31		M	11/20/2006	Hives break out on Fri, Monday 24 hours later.										11/16/2006	11/17/2006	1		OTH	OTH						1						1	Urticaria	FLU3~SANOFI PASTEUR~U2250AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267397	11/20/2006	MD	49.0	48		M	11/20/2006	Pt claims nurse administered vaccine on triceps not deltoid initially there was some redness and swelling at injection site. Numbness, pain, weakness which extended from shoulder to fingers which continued until 2nd week in Nov. Had appointment with neurologist on 17 but further testing cancelled since pt had recovered. Had doctor visit today.				Y					Y	10/27/2006	10/27/2006	0	During ER visit X ray neg for possible broken needle.	OTH	OTH			Allergic to penicillin			1						1	Asthenia; Hypoaesthesia; Injection site erythema; Injection site oedema; Injection site pain; Medication error; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0267398	11/20/2006	PA	41.0	40		F	11/09/2006	Pt c/o blurring vision shortly after vaccination (30 minutes). Pt is 8 months pregnant also. Symptoms resolved on its own with no further problems.									Y	10/26/2006	10/26/2006	0		UNK	UNK		NONE				1						1	Unintended pregnancy; Vision blurred	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71641~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267399	11/20/2006	LA	39.0	39		F		2 days post Flu vaccination, redness at site, swelling, warmth and painful to touch.										11/17/2006	11/18/2006	1	NONE	PUB	PVT		NONE	Eggs			1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA739AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0267400	11/20/2006	OH	1.56	1	.6	F	11/20/2006	Breakthrough varicella diagnosed per office visit 11/20/06, Varivax given 10/05/2006.									U	10/05/2006	11/06/2006	32	Office exam	PVT	PVT		NONE	H/O Otitis Media			1						1	Viral infection	DTAP~SANOFI PASTEUR~U1965AA~4~~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1787AA~3~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1016N~1~~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0267401	11/20/2006	CO	48.0	47		F	11/20/2006	Pts arm was burning which started immediately with needle. Several hours later she started having HAs and dizziness (ran into a wall at home) seen in ER and told symptoms were mostly likely due to adverse reaction to flu vaccine, took Benadryl helped a little.				Y					Y	11/15/2006	11/15/2006	0	NONE	PVT	PVT	Fexofenadine, Zyrtec, Rhinocort.	NONE	Allergic Rhinitis, conjunctivitis, Allergy to Amoxicillin and sulfa.			1						1	Dizziness; Headache; Thermal burn	FLU3~SANOFI PASTEUR~U2255AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0265465	11/21/2006		59.0			F		A report was received from a health care professional via another company (E200605554) on 11/8/06 concerning a 59 year old female vaccinee. The vaccinee has a medical history of diabetes. On 10/11/2006 the vaccinee received Fluvirin and Pneumovax vaccination in separate arms. The vaccinee then developed an injection site reaction in the arm where the pneumovax was administered, that ranged from redness, blotchiness and pain. Medical attention was sought. It was also reported that the vaccinee had a problem with her blood sugar, that was described as went into a diabetic coma, but came right out. The vaccinee did not visit the hospital. The vaccinee is reported to be still experiencing symptoms. The diabetic coma was considered by the reporter to be an important medical event (OMIC).									N	10/11/2006	10/11/2006	0		UNK	UNK	Concomitant drugs not reported		Diabetes		CVOX200500594	1						2	Condition aggravated; Diabetic coma; Injection site erythema; Injection site pain; Injection site reaction; Rash macular; Blood glucose increased; Condition aggravated; Diabetic coma; Injection site erythema; Injection site pain; Injection site reaction; Rash macular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71033~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1007P~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~1007P~UNK~~UN~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0267494	11/21/2006	PA	27.0	27		M	11/09/2006	This is a 27 year old male, with a history of irritable bowel syndrome and lactose intolerance, who received FluMist for the first time on 10/5/06. On 10/6/06 the pt developed a fever of 102 and fatigue two days later, on 10/8/06, the pt was having trouble breathing and was admitted to the hospital. Upon admission, the pt was given a diagnosis of pneumonia. The pt was treated for his symptoms and was discharged on 10/10/06. For the next two weeks, the pt returned to work despite having a persistent mild fatigue. In the following month, the pt was hospitalized two more times for other serious medical problems. There is no further information regarding course of events. lab diagnostic testing results, treatments, and event outcome. The reporter was requested to forward all pertinent pt medical information to product safety at manufacturer. The provided reporter causality is definite. 05/15/07-records received from facility for DOS 11/9-11/22/06-DX DX: Mycarditis. Initially treated for pneumonia. Subsequently developed chest pain found to be in complete heart block with a troponin of 4 and CK of 140. Cardiac cath clean, spontaneously converted to junction rthythm. Cardiac MRI showed inferolateral LV wall and epimyocardium was involved sparing the endocardium. Developed pulmonary edema. tiring tachypneic, ultimarely intubated. Extubated. Developed bradycardia and progressed to left bundle branch pattern wide complex with palpations and dizziness. Pacemaker placement. Echocardigram showed normal LV size decrased function and a PASP of 38%. RPR, blood culture, urine cultue negative. Brochoscopy culture negative. Interesting that his FluMist vaccination was temporarily related to the beginning of what looked like a URI episode and ultimately developed in his first initial experience of chest pain and shortness of breath. Per annual follow up: Reporter indicated that the patient had finaly recovered from the event with a pacemaker. 07-Mar-08 Follow up: Has pacemaker. Top part of heart does not work, only bottom with pacemaker. On blood thinners. Low endurance. Heart races at times. SOB at times. Prior to vaccine he was in good health. His job as an EMT fire fighter required frequent physicals.					Y	2			N	10/05/2006	10/06/2006	1	records received 5/15/07-troponin of 4 and CK of 140. Cardiac cath clean, spontaneously converted to junction rthythm. Cardiac MRI showed inferolateral LV wall and epimyocardium was involved sparing the endocardium. Echocardigram showed normal LV size decrased function and a PASP of 38%. RPR, blood culture, urine cultue negative. Brochoscopy culture negative. 1/13/2010 My heart doesn't work without the pacemaker. I am on Coumadin. I get tired much easier. I get full of fluid easy and short of breath. I can't do many normal things because of this and the possibility I could bleed. If my pacemaker stops I could die before I get help.	MIL	OTH	Concomitant Drug (s) Not Used	Penicillin Allergy			MEDI0005114	1						1	Atrioventricular block complete; Bronchoscopy normal; Dyspnoea; Fatigue; Hypersensitivity; Irritable bowel syndrome; Lactose intolerance; Pneumonia; Pyrexia; Atrioventricular block; Cardiac failure; Fatigue; Heart rate decreased; Myocarditis; Pneumonia; Rash; Atrioventricular block; Cardiac failure; Cough; Dyspnoea; Fatigue; Heart rate decreased; Hypoxia; Myocarditis; Pneumonia; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500430P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500430P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|FLUN3~MEDIMMUNE VACCINES, INC.~500430P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3	USA	Hospitalisation	Influenza
0267494	11/21/2006	PA	27.0	27		M	11/09/2006	This is a 27 year old male, with a history of Irritable Bowel syndrome and lactose intolerance, who received FluMist for the first time on 10/5/06. Two days later, the pt was hospitalized for two days for pneumonia. For two weeks following the discharge, the pt returned to work despite having a persistent mild fatigue (cross referenced to MEDI0005114). On 10/25/06, the reporter (pts mother registered nurse) took the pts pulse and noticed that his pulse rate was down to 40 beats per minute. The pt was taken to the hospital and was admitted for an observation. On the following day, the pt developed a rash on his truck. Cardiac cath and echocardiogram results showed that this pt had a complete heart block. Plans for inserting pacemaker was diverted when the pt cardioverted himself. On 10/28/06, the pt was transferred to University medical center for cardiac and pleural biopsies. Cardiac MRI result showed that the pt had a myocarditis. Above planned biopsies were cancelled after evaluation the risk vs benefit and the pt was discharged on 11/1/06. On 11/6/06, five days after the discharge, the pt was readmitted to the hospital. Seven days later, the pt was given a diagnosis of a heart failure (cross referenced to MEDI0005134). There is no past medical history of heart problems/diseases. There is no family history of cardiac disorders or diseases. There is no family history of cardiac disorders or diseases. There is no history of smoking or alcohol substance abuse. The pt did not receive any other vaccines three months prior to receiving FluMist. There is no further information regarding course of events, lab/diagnostic testing results, treatments, and event outcome. The reporter was requested to forward all pertinent pt medical information to product safety at manufacturer. The provided reporter causality is definite.			Y		Y	7	Y		U	10/05/2006	10/25/2006	20	Cardiac Cath 10/26/06 complete heart block, cardiac MRI myocarditis, echocardiogram 10/26/06 complete heart block.	MIL	OTH	Concomitant Drug (s) Not Used	Fatigue			MEDI0005133	1						2	Atrioventricular block complete; Bronchoscopy normal; Dyspnoea; Fatigue; Hypersensitivity; Irritable bowel syndrome; Lactose intolerance; Pneumonia; Pyrexia; Atrioventricular block; Cardiac failure; Fatigue; Heart rate decreased; Myocarditis; Pneumonia; Rash; Atrioventricular block; Cardiac failure; Cough; Dyspnoea; Fatigue; Heart rate decreased; Hypoxia; Myocarditis; Pneumonia; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500430P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500430P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|FLUN3~MEDIMMUNE VACCINES, INC.~500430P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3	USA	Life Threatening,Hospitalisation	Influenza
0267494	11/21/2006	PA	27.0	27		M	11/09/2006	This is a 27 year old male, with a history of irritable bowel syndrome and lactose intolerance, who received FluMist for the first time on 10/5/06. Two days later, the pt was hospitalized for two days for pneumonia. For two weeks following the discharge, the pt returned to work despite having a persistent mild fatigue (cross reference to MEDI0005114). On 10/25/06, the pt was readmitted to the hospital for decreased in pulse rate. The pt was hospitalized for the following seven days with the rash on trunk. Diagnostic testing indicated that this pt had a complete heart block and the cardiac MRI showed that he had a myocarditis. The pt was discharged on 11/1/06 (cross referenced to MEDI0005133). On 11/6/06, fiver days after the discharge, the pt was readmitted to the hospital with a productive cough and trouble breathing. On 11/9/06, the pt was transferred to University medical center for worsening of the above symptoms. The pt was placed on a ventilator and on 11/13/06, he was given a diagnosis of heart failure. There is no past medical history of heart problems of disease. There is no family history of cardiac disorders or diseases. There is no history of smoking or alcohol substance abuse. The pt did not receive any other vaccines three months prior to receiving FluMist. There is no further information regarding course of events, lab diagnostic testing results, treatments, and event outcome. The reporter was requested to forward all pertinent pt medical information to product safety at manufacturer. The provided reporter causality is definite.			Y		Y	0	Y		U	10/05/2006	11/06/2006	32		MIL	OTH	NONE	Penicillin allergy			MEDI0005134	1						3	Atrioventricular block complete; Bronchoscopy normal; Dyspnoea; Fatigue; Hypersensitivity; Irritable bowel syndrome; Lactose intolerance; Pneumonia; Pyrexia; Atrioventricular block; Cardiac failure; Fatigue; Heart rate decreased; Myocarditis; Pneumonia; Rash; Atrioventricular block; Cardiac failure; Cough; Dyspnoea; Fatigue; Heart rate decreased; Hypoxia; Myocarditis; Pneumonia; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500430P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500430P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|FLUN3~MEDIMMUNE VACCINES, INC.~500430P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3	USA	Life Threatening,Hospitalisation	Influenza
0267496	11/21/2006	ND	9.0	9		F	11/15/2006	Patient was administered Fluzone and immediately a tonic seizure. 01/16/07-records received afrom doctor and reviewed. Seizure immediately following a flu shot, body stiffened, eyes rolled back and she was unresponsive. Patient's uncle has history of tonic clonic siezure. Patient has had asthma in 2002 and is on Advair. EEG:11/10/06. MRI: No acute intracranial pathology.  02/16/07-records received and reviewed from Dr. for DOS 11/10/06. Physical exam WNL; Seizure (GT type) within few seconds. Had generalized tonic spasm of body all 4 extremities and moving of eyballs within few second of injection of vaccine. Became fully concious and responsive in 2 minutes. Did not void.			Y						Y	11/10/2006	11/10/2006	0	The absence of epileptogenic activity does not rule out the possibility of a convulsive disorder. MRI and EEG normal.	UNK	UNK			Asthma			1						1	Convulsion	FLU3~SANOFI PASTEUR~U2220NA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0267501	11/21/2006	TX	43.0	42		F	11/13/2006	Dizzy, cotton mouth, disoriented, unable to stay awake, lower blood pressure, nauseated, headache.									Y	11/07/2006	11/07/2006	0		OTH	PVT	Crestor					1						1	Blood pressure decreased; Disorientation; Dizziness; Dry mouth; Headache; Nausea; Somnolence	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72002~4~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267502	11/21/2006	TN	42.0	42		F	11/14/2006	Received Flu and Pneumovax around 2:30 pm.  That night awoke to pain in Pneumovax arm with swelling from shoulder to elbow, temperature 102, couldn't move due to pain.  Pain was shootingup neck and down side.  Went to the ER the next day as symptoms worsened.  ER gave her IV fluids/antibiotics and sent home.  Her regular physician was seen on Monday with no new treatment.  Over the course of her symptoms, she had taken ADVIL and TYLENOL.  As of 11-14-06 states her temperature is now 99.9 and her arm is still warm to touch and painful but the swelling has gone down.				Y					Y	11/10/2006	11/11/2006	1	NONE	PUB	PVT		NONE	NONE			1						1	Injection site warmth; Pain; Pyrexia; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70620~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0620F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0267503	11/21/2006	VA	52.0	52		F	11/10/2006	Pt developed raised red rash flexal area with pruritus of the arms, palms soles about 8 hours after administration of vaccine. Then developed mild pharyngeal swelling all SX resolved with self TX with Benadryl.									Y	11/08/2006	11/08/2006	0		OTH	PVT		NONE	Anaphylaxis to Naproxin, Sulfa, DM, High Cholesterol, HTN.			1						1	Erythema; Injection site swelling; Oedema; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA210AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0267504	11/21/2006	OR	31.0	30		M	11/15/2006	Pt developed headache, fatigue and bilateral generalized lymphadenopathy, (cervical, axillary, and inguinal), that continues even 1 week after vaccination.										11/08/2006	11/13/2006	5	Labs WNL, CBC, ESR, Monospot, Strep throat culture.	MIL	MIL	NONE	NONE	NONE			1						1	Fatigue; Headache; Lymphadenopathy	FLU3~SANOFI PASTEUR~U2286AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267505	11/21/2006	IL	76.0	76		F	11/15/2006	Received pneumonia vaccine 11/13/06.  Itching 1st day 11/14/06 left arm deltoid red, swollen.  Site of softball.				Y					U	11/13/2006	11/14/2006	1		PVT	UNK		NONE				1						1	Oedema peripheral; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA236BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0876R~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0267506	11/21/2006	IA	5.0	5		M	11/16/2006	11/14/06 Influenza vaccine.  11/15/06 Arm reddened and swollen, temperature 103.  11/16/06 Arm increased swelling and redness, clusters of blisters around injection site.				Y					Y	11/14/2006	11/15/2006	1	Culture and Sensitivity of blisters (pending), WBC 9.6	PVT	PVT		Upper respiratory infection	NONE	large local reaction~DTaP (no brand name)~~5.00~In Patient		1						1	Injection site vesicles; Oedema peripheral; Pyrexia	FLU3~SANOFI PASTEUR~42262AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267509	11/21/2006	MI	9.0	9		M	11/15/2006	6 to 7 hours after receiving the flu vaccine he complained of heaviness in his arms and legs.  They feel like they weigh too much.  Became very upset.  Mom had to calm him calm lasted about 20-30 minutes.									N	11/14/2006	11/14/2006	0		OTH	OTH						1						1	Sensation of heaviness	FLU3~SANOFI PASTEUR~AFLUA200BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267510	11/21/2006	AL	17.0	17		F	11/15/2006	Fluvirin was given around 3pm. Per patient at about 8-9pm, patient started to feel very dizzy.  She can hardly stand, left side of her body numbness and she couldn't breath and had asthma attack use ALBUTEROL inhaler.  Went to sleep.  The signs and symptoms resolved after 3-4 days.				Y					Y	11/06/2006	11/06/2006	0	NONE when patient came in 11-7-06 am, most of symptoms had subsided.	PVT	PVT	ALBUTEROL inhaler	NONE (asthma was stable)	asthma			1						1	Dizziness; Dyspnoea; Hypoaesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70736~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0267511	11/21/2006	FL	3.0	3		F	11/15/2006	18 h after having Flu vaccine on left arm, pt developed erythema, swelling, induration at the area where she had vaccine, approx 11 x 9 cm; and some itching bearing to the area. Pt was treated with Benadryl 12.5 g/5 5ml even 6 h and Orapred PO daily x 3 days.				Y					Y	11/13/2006	11/14/2006	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site reaction; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U2275AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267512	11/21/2006	WA	67.0	67		F	11/16/2006	2 cm area of induration in a 4 cm patch of erythema. Pain is improving, rash appears to be fading.									Y	11/07/2006				PVT	PVT		NONE				1						1	Injection site erythema; Injection site induration; Pain; Rash	FLU3~SANOFI PASTEUR~U2219AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0620F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267513	11/21/2006	KS	19.0	19		F	11/16/2006	A few hours after vaccine - developed tightness in throat, raspy hoarse voice, shortness of breath. Solumedrol IV (pt pregnant)				Y					Y	10/16/2006	10/16/2006	0		PVT	UNK						1						1	Dysphonia; Dyspnoea; Throat tightness; Unintended pregnancy	FLU3~SANOFI PASTEUR~U2239AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267515	11/21/2006	NY	49.0	49		F	11/10/2006	Flu vaccine reaction. Vaccine administered to left deltoid on 10/23/06. Left arm pain and swelling fine 10/23/06 - got worse on 10/27. Went to ER. Treated with Benadryl 25 mg PO every 4-6 hrs prn and Predisone 40 mg PO daily x 4 days.									Y	10/23/2006	10/25/2006	2	NONE	MIL	UNK		NONE	NONE			1						1	Injection site pain; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69480~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267517	11/21/2006	AZ	58.0	58		M	11/03/2006	Local pain, swelling RUE near site Pneumovax within hours of injection. has improved but still some soreness, exam showed only tenderness.									Y	10/27/2006	10/27/2006	0	CBC, SR, CPK requested today	PUB	OTH		NONE	DM, radiculopathy neck.			1						1	Injection site oedema; Injection site pain; Tenderness	FLUX~UNKNOWN MANUFACTURER~AFLUA222AA~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0604R~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267518	11/21/2006	CA	1.68	1	.7	M	11/16/2006	Hives, fever no resp distress. MR and Vax record received. Healthy apprearing 20 month old male with 4 day hx. of diarrhea (improving) who received Dtap, Prevnar, and Flu vax on 11/15/2006, presented to MD with c/o rash which developed the evening of his vax. Assessment:  Urticaria-probably secondary to flu vaccine, but can be related to viral illness, tylenol admin., or other immunizations.										11/15/2006	11/15/2006	0	NONE	PUB	UNK	Tylenol	4 day history of diarrhea.	NONE			1						1	Pyrexia; Urticaria	DTAP~UNKNOWN MANUFACTURER~~UNK~~UN~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PNC~PFIZER\WYETH~~UNK~~UN~PNEUMO (PREVNAR)~1	USA		Influenza
0267519	11/21/2006	TX	1.2	1	.2	F		Poor balance within 24 hours after vaccines lasted 3-4 days, pt did not contact MD until symptoms resolved and was not examined.									Y	10/27/2006	10/28/2006	1		PVT	PVT						1						1	Balance disorder	DTAPH~SANOFI PASTEUR~U1891AB~4~~UN~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~UE21745A~1~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB110AA~1~~UN~HEP A (HAVRIX)~1|MMRV~MERCK & CO. INC.~0818F~1~~UN~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08691A~4~~UN~PNEUMO (PREVNAR)~1	USA		Influenza
0267520	11/21/2006	CO	32.0	32		M	11/10/2006	Pt had anaphylactic reaction 4-5 minutes after receiving in influenza vaccine, throat swelled up. Rn immediately gave client 0.cc epinephrine SQ and laid client down BP 80/40. Responded immediately BP increased 150/80 EMT to ER.				Y					Y	11/09/2006	11/09/2006	0		PUB	PVT						1						1	Anaphylactic reaction; Blood pressure decreased; Pharyngeal oedema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71828~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0267521	11/21/2006	KS	24.0	24		F		Tightness of throat and dyspnea (pt pregnant) Solumedrol IV.				Y					Y	10/24/2006	10/24/2006	0		PVT	UNK			Pregnant			1						1	Dyspnoea; Throat tightness; Unintended pregnancy	FLU3~SANOFI PASTEUR~U2239AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267522	11/21/2006	MN	53.0	53		M	11/17/2006	Swelling of hands, redness of skin, generalized itching day of vaccine. Symptoms progressed over 3 days to swelling of hands and feet, redness of hands and feet, itchy throat, no difficulty swallowing. Feels puffy all over.				Y					Y	11/06/2006	11/06/2006	0	NONE	PVT	OTH	Augmentin, Nasonex	Acute Sinusitis	Seasonal allergies, Sinusitis			1						1	Erythema; Oedema peripheral; Pruritus generalised; Swelling; Throat irritation	FLU3~GLAXOSMITHKLINE BIOLOGICALS~27601711~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0267526	11/21/2006	LA	4.0	3		M	10/31/2006	Maculo papular pruritic rash to abdomen, spread to cheeks, upper back, both elbows and both thighs. spread over 30 mins. Response good to antihistamines.				Y					Y	10/31/2006	10/31/2006	0		OTH	PUB	Singular PO. Poly Vi Flor, Ibuprofen, Ear drops, Losnal PO.	Asthma, middle ear effusion	Amoxicillin.			1						1	Rash maculo-papular; Rash pruritic	FLU3~SANOFI PASTEUR~U2245AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267527	11/21/2006	WA	38.0	38		F	11/15/2006	Swollen arm, stiffness, lump 16 days in area of injection. Throbbing pain radiating down arm.									N	10/30/2006				OTH	OTH						1						1	Injection site mass; Injection site oedema; Injection site pain; Musculoskeletal stiffness; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71926~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267528	11/21/2006	NC	0.76	0	.8	M	11/15/2006	Urticaria (mild). MR received  revealing a 9 month old in for well-baby exam with only c/o mild diarrhea-resolving, otherwise normal. Flu shot given and infant developed hives that evening on face/trunk/back.  Seen 2 days s/p vax. because infant seemed uncomfortable, and was having trouble sleeping. DX: Urticaria, likely 2' to influenza vaccine, treated with Atarax PRN itching.									U	11/13/2006	11/13/2006	0		PVT	PUB		Mild fever, diarrhea-resolving				1						1	Sleep disorder; Urticaria	FLU3~SANOFI PASTEUR~U2187AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267529	11/21/2006	ME	78.0	78		F	11/14/2006	Had Flu shot and Pneumonia shot on 10/27/06. Erythema, Cellulitis given Cephalexiro 500 mg 4x days. Had side effect after 13 doses. Two days later came down with shingles given Acyclovir by my own Dr. I seem to be on the mend after 18 days. I hope so.				Y					Y	10/27/2006	10/27/2006	0		PUB	PUB	HCT, Zanax	NONE	Mild high blood pressure.			1						1	Cellulitis; Erythema; Herpes zoster; Viral infection	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~UN~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0267530	11/21/2006	VA	3.0	3		F	11/16/2006	Next day after flu vaccine noticed rash on legs. Next day rash spread trunk and extremities office visit 11/15/06 DX with Erythema multiforme. No treatment. Not sure if this is related or not to Fluzone.				Y					U	11/13/2006	11/14/2006	1	NONE	PVT	PVT		NONE	RAD			1						1	Erythema multiforme; Rash	FLU3~SANOFI PASTEUR~U2247AA~4~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267531	11/21/2006	CA	45.0	45		M	11/03/2006	Hot, Red, swollen arm 11/01/2006 administered, 11/07/06 presented at office with SX.										11/01/2006	11/03/2006	2		PVT	PVT						1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U2193AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1005F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267532	11/21/2006	CA	67.0	66		F	11/15/2006	Cellulitis like reaction to Pneumovax right arm.										11/14/2006			NONE	PUB	PUB		NONE	Allergy			1						1	Cellulitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0267533	11/21/2006	WA	20.0	20		M	10/31/2006	Fluzone shot 10/27/2006 left arm. Within 12 hours axillary adenopathy left side. Feels well otherwise. No abnormality at site of shot.									Y	10/27/2006				OTH	UNK	NONE	NONE	NONE			1						1	Lymphadenopathy	FLU3~SANOFI PASTEUR~U2186AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267535	11/21/2006	CA	12.0	11		F	11/03/2006	Rash on left deltoid area where inj administered stomach upset that evening and through next two days, then vomiting x 1 day.										10/27/2006	10/27/2006	0		OTH	PVT						1						1	Injection site rash; Stomach discomfort; Vomiting	FLU3~SANOFI PASTEUR~U2166KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267536	11/21/2006	CA	3.0	2	.7	F	11/15/2006	5 minutes of administration pts left arm above elbow red and warm to touch, redness extending around injection site and extending to above elbow. Red blotchy pattern to entire LUE. No other reaction. Benadryl IM given. Redness resolving. Benadryl given for home use.									Y	11/15/2006	11/15/2006	0	NONE	PVT	PUB	Topamax, Lamictal, Zonigran, Robinol, Pulmicort.	NONE	Cerebral Palsy, BPD, single kidney, G Tube, Prematurity, VP shunt.			1						1	Injection site erythema; Injection site warmth; Rash macular	FLU3~SANOFI PASTEUR~U2176EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267537	11/21/2006	AK	44.0	43		F	11/16/2006	I got the flut shot on 25-OCT-2006 so I wouldn't get sick because I don't have a car for over 3 years and have to catch bus/cab which is expensive and dirty. For three weeks straight I've been sick with chest pains, sore ribs, hoarseness and I have to walk to the mail box 30 minutes in the snow/cold with that sickness. It snowed the day after (26-OCT-2006) when I got my shot. Last year the shot didn't make me sick. This year was my second time getting the flu shot. Barely recovered. The two 1-800 numbers didn't work to complain about the vaccine.									Y	10/25/2006	10/26/2006	1		OTH	PUB	NONE	I wasn't sick	Years ago with cerebral palsy and dyslexia		AK200667	1						1	Bone pain; Chest pain; Dysphonia	FLU3~SANOFI PASTEUR~RX7143/93~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267538	11/21/2006	IA	40.0	40		F	11/10/2006	Vaccine given at 7:38am, at 7:45 pt complained of feeling weak going to pass out. Laid flat on cot, legs elevated. BP 12/57, HR 114, RR 16. 7:53 used ammonia pouch without relief, denies shortness of breath 7:58 BP 120/90, HR 100, RR 16 continues to complain of feeling weak. 911 called.				Y					Y	11/10/2006	11/10/2006	0		OTH	UNK	Effexor, Lorazepam, Temazapam.	NONE	NONE			1						1	Asthenia	FLU3~SANOFI PASTEUR~U2253AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267539	11/21/2006	NC	1.03	1	.0	F	11/16/2006	Varicella like rash 9 days after vaccination. >50 red blotchy macule about 1/10 had pustular 1mm center. Not other wise ill. No treatment just reassurance.									Y	11/06/2006	11/16/2006	10		PVT	PUB	Lactulose				NC06097	1						1	Dermatitis bullous; Rash macular; Rash pustular	DTAP~SANOFI PASTEUR~U1751CA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2191AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1161R~3~IM~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~1053R~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08691H~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0911F~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0267540	11/21/2006	NY	67.0	67		M	11/20/2006	3 1/2 hours after receiving vaccine, spouse found pt slouched and unresponsive. After arousing him, he was disoriented, nausea, dizzy,chilly, rapidly breathing x 30 minutes.									U	11/20/2006	11/20/2006	0	EKG normal	PVT	PVT	HCTZ, Ambien	Kidney stones	NONE			1						1	Chills; Coma; Disorientation; Dizziness; Nausea; Respiratory rate increased	FLU3~SANOFI PASTEUR~U2243AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267585	11/21/2006	CT	0.83			M	11/21/2006	Pt had 2nd dose of 0.25ml preservative free Fluzone at 5:50 pm and began wheezing with respiratory distress 45 minutes later. Pt received neb x2 and Prelone with adequate relief. Pt was wheeze free next day.  MR received revealing a healthy 9 month old in for well visit with only c/o mild chest congestion beginning that am. 1st Flu given at that time with no problem.  Infant began wheezing ~45 minutes after 2nd vax. Seen by MD and PE showed mild respiratory distress, a RR of 70, audible wheezing and decreased aeration. Given Xopenex nebs and Orapred with improvement noted.  F/U next day with resolution of wheezing, and lungs CTA.  Nebs were continued for 48 hrs.													Pulse Sat >95%	PVT	UNK			PMH includes 1 past episode of wheezing.			1						1	Respiratory distress; Tachypnoea; Wheezing	FLU3~SANOFI PASTEUR~U2174EA~2~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267586	11/21/2006	TN				U		Nausea, vomiting x 1, itching, red face, throat swelling sensation, numbness and tingling in hands and face.				Y					Y	10/10/2006	10/10/2006	0	NONE	PUB	OTH		NONE				1						1	Erythema; Hypoaesthesia; Nausea; Paraesthesia; Pharyngeal oedema; Pruritus; Vomiting	FLU3~EVANS VACCINES~70278~1~SC~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0267587	11/21/2006	MI				F	11/20/2006	Nausea and Vomiting.									Y	11/15/2006	11/15/2006	0		PVT	PVT						1						1	Nausea; Vomiting	FLU3~SANOFI PASTEUR~U2261AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267588	11/21/2006	CA	39.0	39		F	11/03/2006	AT deltoid, red, hot to touch, hard ball 62mm x 36mm. Body aches.										11/02/2006	11/03/2006	1		OTH	PVT	NONE	NONE	Had reaction to last TD also.	Same~Td Adsorbed (no brand name)~~35.00~In Patient		1						1	Injection site erythema; Injection site induration; Injection site warmth; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70384~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267590	11/21/2006	IN	40.0	41		M	11/21/2006	Recieved flu vaccine in Right Deltoid.  Reported swelling and tenderness under R arm in armpit area.  Resoved with in 5 days with out medical intevention.									Y	11/15/2006	11/17/2006	2		UNK	UNK	Unknown	None	Migraines			1						1	Migraine; Swelling; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA231BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0267591	11/21/2006	MI	60.0	60		F	11/21/2006	Day of vaccine, developed elevated temperature, chills, nausea, spastic BM's, body ache, severe swelling of left arm; splotchy red rash on left arm spreading to neck, other arm and partially down chest; 3 very sore lumps on left arm.  Rx'd on 11/19/06 with Keflex qid and Zyrtec. 11/21/2006 A little better, 2 lumps on arm still present (2 and 1 1/2 diameter) - a little better.  Private provider (staff) stated client did not need to be seen if she were improving.				Y					N	11/16/2006	11/16/2006	0	no labs were done	UNK	UNK		none	auto accident with injury to lung, spleen, rheumatoid arthritis			1						1	Chills; Erythema; Nausea; Pain; Pyrexia; Rash; Swelling	FLU3~SANOFI PASTEUR~U2248AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0619F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0267592	11/21/2006	OH	55.0	55		F	11/21/2006	Complained of severe flank pain and inablility to walk.  Sat down in chair in lobby.  Given juice and encouraged for her to relax.  Emergency squad called and VS checked BP 156/98 per squad members.  Declined transport.  Encouraged her to seel medical attention at the local hospital, daughter in law picked up and advised of this as well.  When patient left, she voiced she felt much better and was able to walk out to car by herself.									U	11/21/2006	11/21/2006	0		UNK	UNK		none noted	Without spleen			1						1	Abasia; Blood pressure increased; Flank pain	FLU3~SANOFI PASTEUR~U2261AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0741R~2~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U1704AA~2~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0267593	11/21/2006	TX	62.0	62		M	11/21/2006	Flu Vaccine innoculation:  11/07/06 Sore throat, sinus infection, chest conjestion:       11/11/06      11/13-15/06 - worsening symptoms      11/16-17/06 - bed riddden (fever of 102.1 deg. F) - physician prescribed 5-day regimen of Azithromycin antibiotic (500 mg dose - first day; 250 mg dose thererafter)      11/21/06 - much improved; oral cavities and chest draining				Y					Y	11/07/2006	11/13/2006	6	None	UNK	UNK	None	None	moderately high blood pressure			1						1	Infection; Nasal congestion; Pharyngolaryngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0267594	11/21/2006	MN	43.0	43		F	11/21/2006	Influenza Injection received 11/01/06.  Sore Throat started 11/3/06.  Acute pharangitis lasted 7 days.  Hoarseness lasted about 7 days as well.  Nasal congestion started about 5 days after injection and continues.  Fevers/Chills started about 7 days after injection and continued till 11/18/06.  Fever Max 101.4.   Out of work for 2 weeks.				Y					Y	11/01/2006	11/03/2006	2	Throat Culture x 2 Negative for Strep CBC within normal limits Mono Spot Negative Blood Culture Negative	UNK	UNK	Currently taking: Multivitamin, Flonase, Claritin, Ibuprofen as needed, Tylenol as needed	None	Sulfa Allergy, Anovulation			1						1	Chills; Nasal congestion; Pharyngitis; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA201AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0267595	11/21/2006	CT	58.0	57		F	11/21/2006	On 11/17/06 patient experienced weakness, fatigue, aches, sweats.  Went to see doctor on 11/21/06 and doctor diagnosed patient with Bells Palsy. 03/15/07-records received from PCP for DOS 11/7/06-1/30/07- note dated 11/7/07-DX:Bell's Palsy. Visit 1/23/07-upper respiratory infection. Otalgia onleft side. 1/30/07-DX: otitis externa. PE:Opens/closes eyes without problem. Asymmetric smile.									Y	11/16/2006	11/17/2006	1		UNK	UNK	none	none	none records received 3/15/07-PMH:Epstein Barr titer positive.			1						1	Asthenia; Facial palsy; Fatigue; Hyperhidrosis; Pain	FLU3~SANOFI PASTEUR~u2197aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267596	11/21/2006	MI	46.0	46		F	11/21/2006	Patient developed a significant local reaction at the injection site requiring antibiotics, steroids and analgesics.				Y					Y	11/08/2006	11/09/2006	1		UNK	UNK		None	Thimerosal, but states that she received previous vaccines without problem, including the influenza vaccine.  This was the first time receiving Pneumovax.			1						1	Injection site reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA237BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0674E~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0267598	11/21/2006	AK	25.0	25		F	11/21/2006	Around noon had pain in left area of forehead, took Rx Midril 2 tablets for migraine then 2 tabs more @ 2am 11/16/06.  Had nausea, light sensitivity & dull ache for 4 more until noon on 11/17/06.									Y	11/15/2006	11/15/2006	0	Hx of migraine X 18 years	UNK	UNK	Rx. Midril taken three hours after vaccine injection.	none	Allergy to Keflex & Clineril			1						1	Migraine; Nausea; Pain; Photophobia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA223AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0267600	11/21/2006	VA	49.0	49		F	11/21/2006	Raised red rash under affected arm 48 hours later x 3 days; noticed indentation in armpit 96 hours later; atrophy left deltoid muscle 1 week later.				Y						11/10/2006	11/11/2006	1		UNK	UNK	Tamoxifin	None	Allergies: Tylenol with codeine, Keflex			1						1	Rash erythematous; Skin atrophy; Muscle atrophy; Rash; Rash maculo-papular	FLU3~SANOFI PASTEUR~U2275AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2275AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0267601	11/21/2006	TX	29.0	29		M	11/21/2006	Nose started bleeding last night at around 12:00am after receiving Flumist earlier in the day.  It stopped bleeding only to start again about an hour later.				Y					Y	11/18/2006	11/19/2006	1	None	MIL	MIL	Unknown	None	None			1						1	Epistaxis	FLUN3~MEDIMMUNE VACCINES, INC.~500431P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0267603	11/21/2006	NJ	43.0	43		F	11/21/2006	On 10/25/06 Flu Vaccination given. Patient noted rt arm (deltoid) more tender then usual and has remained for over three weeks. Pain has improved but still present and bothersome with movement. No pain at rest. No weakness or numbness and tingling.									U	10/25/2006	10/25/2006	0	None	UNK	UNK		None	None			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U2197AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267604	11/21/2006	FL	33.0	33		F	11/21/2006	within 15 minutes of vaccine, symptoms of lethargy, pallor, weakness, and tightness in throat.				Y					Y	11/16/2006	11/16/2006	0	none	UNK	UNK	Effexor, Sunthroid, Xanax, Motrin	none	allergies:  EES, Cipro, PCN, Hydrocodone, Codeine. Dx: Hypothyroidism, fibromyalgia			1						1	Asthenia; Lethargy; Pallor; Throat tightness	FLU3~SANOFI PASTEUR~U2248AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267608	11/21/2006	NJ	0.69	0	.7	M	11/21/2006	no adverse events as of yet.  8 month old received immunizations scheduled for a 4 year old.										11/21/2006				UNK	UNK			upper respiratory infection			1						1	Medication error	DTAP~SANOFI PASTEUR~u1397ba~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~u2201ba~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~z0018~4~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~1123f~1~IM~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0267616	11/21/2006	GA	70.0	70		F	11/21/2006	My mother had a doctor's appointment with MD for a flu shot 10:00 am on November 6, 2006. Immediately after the shot at approximately 11:00 am as they were driving away from the office she started gasping for breath, the paramedics were called and they never revived her.	Y	11/06/2006							N	11/06/2006	11/06/2006	0		PVT	OTH	Yes	High blood pressure/diabetes				1						1	Dyspnoea	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0267617	11/21/2006	IL	67.0	67		F	11/10/2006	Right arm erythema, warmth and pain starting one day after receiving Pneumococcal and influenza shots in same arm.									Y	11/06/2006	11/07/2006	1		PUB	UNK			Hypertension			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~42245AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1048P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267618	11/21/2006	CA	12.0	11		F	11/21/2006	Pt had likely partial complex seizure 10 minute after vaccine so went to ER. No prior seizure.				Y					Y	11/06/2006	11/21/2006	15	EEG suggested focal.	PVT	PVT			NONE			1						1	Convulsion	FLU3~SANOFI PASTEUR~U2167MA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267620	11/21/2006	WI	78.0	77		M	11/21/2006	Has had nausea and diarrhea, was vomiting even through nose, for a day and a half. Took some Pepto Bismol, stool finally began to harden today. Pt feeling much better.									Y	11/15/2006	11/17/2006	2		OTH	PUB	Multi Vitamin, High blood pressure pills, Glyburide, Furosemide.		High Blood pressure, Diabetes.			1						1	Diarrhoea; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0267621	11/21/2006	WI	78.0	77		F	11/21/2006	Nausea and diarrhea. She was vomiting and fainted in the kitchen floor hitting the wall and making a hole. The nausea and diarrhea have decreased but still feels bad.									U	11/15/2006	11/15/2006	0		PUB	PUB	Multivitamin, High blood pressure Pills, Synthroid		High blood pressure.			1						1	Diarrhoea; Fall; Malaise; Nausea; Syncope; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~RA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0266665	11/22/2006	GA	24.0	24		F	11/16/2006	Information has been received from a registered nurse concerning a 24 year old female with a penicillin allergy and a history of a splenectomy who on 10/27/2006 was vaccinated SC in the left arm with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 651329/1047P). Concomitant vaccine therapy included a dose of influenza virus vaccine (unspec). There was no other concomitant therapy. That evening the pt experienced a cellulitis like reaction at the injection site. Her left arm became red, swollen and sore and she developed a fever. On 10/28/06 the pt developed shortness of breath and was hospitalized. The pt was diagnosed with cellulitis of the left arm. During her stay she was administered an unspecified antibiotic through a PICC line. Her white blood cell count was 46.2. All cultures were negative. An MRI of the upper left arm was performed. She was hospitalized for 5 days. On 11/7/06 the pt was seen by a physician and was reported to be recovering. On 11/14/06 it was reported that the pt had fully recovered (exact date not specified). It was noted that the pt had been vaccinated with Pneumococcal 23v polysaccharide vaccine five years ago with no reported reaction. The nurse is requesting that a lot check be performed. No product quality complaint was involved. The reporter felt that the pts experiences were considered to be immediately life threatening and other important medical events (OMIC). Additional information has been requested.			Y	Y	Y	5			Y	10/27/2006	10/27/2006	0	MRI 10/28/06, Blood culture 10/28/06 neg, WBC count 10/28/06 46.2.	OTH	OTH			Splenectomy, immunisation. Penicillin allergy.		WAES0611USA02325	1						2	Injection site erythema; Pyrexia; Cellulitis; Dyspnoea; Injection site erythema; Injection site oedema; Injection site pain; Injection site reaction; Pyrexia; White blood cell count increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70736~1~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1047P~2~SC~LA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~1047P~UNK~SC~LA~PNEUMO (PNEUMOVAX)~2	USA	Life Threatening,Hospitalisation	Influenza
0267610	11/22/2006	CA	81.0	81		M	11/22/2006	Vaccine administered 11/3/06. 11/8/06 atient developed a bronchopneumonia syndrome, treated from ED with 5 days of Azithromycin. On 11/17/06 I admited him to hospital with a TIA causing left hemiparesis and speach deficit. He cleared neurologically but still feels terribly weak. -- Maybe unrelated, but I thought I'd report.  MR from PCP received.  HPI: Four days S/P flu vax. patient developed symtoms of bronchitis vs. pneumonia and was treated in the ER with Zithromax.  He was seen on day 10 s/p vax still c/o weakness, fever, and unintentional weight loss. Assessment:  Viral URI. On 11/17/2006 (2 weeks s/p flu vax.) he awoke from a nap with left sided hemiparesis, facial ptosis, and slight expressive aphasia. He was admitted to the hospital with a DX: Resolving CVA/TIA. Impression: resolving CVA/TIA probably in the left midbrain area. F/U visit on 11/21/2006  for c/o weakness, severe fatigue, and 10 lb. weight loss since getting flu shot. Assessment: Fatigue with terrible loss of appetite, ? pallor, ? due to flu vax. pneumonia recovery, TIA recovery, ?? another process in the brain/brainstem. TIA, Bronchitis acute. MR received from hospital.  No new COSTARTs.  No discharge summary sent with records. No d/c summary available.			Y	Y	Y	1			U	11/03/2006	11/07/2006	4	CXR with peribronchial cuffing. CBC unremarkable. MRI:left brainstem calcified infiltrate and MRA shows a little R ICA stenosis without much other vascular disease. LABS and DIAGNOSTICS: EKG shows SR with occ. PACs. Hgb 12.2, Hct. 36, Plts 470,000.  BMP WNL. PT 13.9 sec., INR 1.4, PTT 24 sec.  Brain MRI shows a 1 cm. lesion of the left posterior midbrain. ? unusual calcification, mild global atrophy and eveidence of small vessel disease.  MRA shows possible left vertebral artery stenosis and very mild plaque formation of the right internal cerebral artery.	UNK	UNK	Meds: Effexor XR, Advair Diskus, Elocon, and DSS.	none	post polio, Depression, BPH, ED, Asthma.  Allergy to Cat and dogs. PMH: BPH S/P TURP X3, erectile dysfunction, Polio 1956 with post-polio cough, dysphagia, swallowing problem, hearing deficit, asthma, alcoholism, depression.			1						1	Asthenia; Bronchitis; Cerebrovascular accident; Decreased appetite; Eyelid ptosis; Fatigue; Hemiparesis; Laboratory test abnormal; Pallor; Pneumonia; Pyrexia; Speech disorder; Transient ischaemic attack; Viral infection; Weight decreased	FLU3~SANOFI PASTEUR~u2441AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0267622	11/22/2006	MT	73.0	72		F	11/21/2006	Client states she became lethargic and could not move her arms or speak. She was taken by ambulance to the ER, The doctors could not find any indications of a stroke or other complication. Dr stated he dose not believe this incident was related to the flu vaccine.  12/19/06 Received hospital records which reveal patient admitted 11/14/06 for observation after feeling paresthesia, sleepiness, dizziness & speech impairment s/p flu shot.  Overnight observation. Improved & d/c home in AM 11/15/06. Final DX: possible adverse reaction fo flu vaccine w/hyperventilation.					Y	1			Y	11/14/2006	11/14/2006	0	CT Scan, EKG LABS: CT of head was WNL.  Na 134, AST 10.  CBC was WNL.	PUB	PVT						1						1	Aphasia; Dizziness; Hyperventilation; Hypokinesia; Lethargy; Paraesthesia; Somnolence; Vaccination complication	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71833~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0267624	11/22/2006		62.0			M	11/17/2006	Initial information was received on 11/13/06 from the aforementioned literature citation. A 62 year old male pt, with a past medical history of hypertension and alcoholic liver cirrhosis, for which he underwent orthotopic liver transplantation, received an influenza vaccination on an unspecified date. The trade name, manufacturer or lot number were not reported. Two weeks after receiving the vaccine, the pt developed progressive generalized weakness and was diagnosed with Guillain [[name]]e Syndrome. He was seen in a hospital one week after the onset of symptoms, where he was found to have an elevated FK506 level (18.1 ng/ml, and the dose of FK506 was adjusted. His weakness worsened, and he was admitted to another hospital two weeks after th onset of the symptoms. The pts liver transplantation as six months prior to admission. Since then, he had been on FK506 and a low dose of prednisone without any complications. He denied any precedent episodes of diarrhea, nausea, vomiting, or other gastrointestinal or upper respiratory illness. Neurological examination on admission revealed normal mental status, bilateral facial weakness, dysphagia, hypophonia, quadriplegia ( 1-2/5 by Medical research council scale), throughout, and absence of muscle stretch reflexes in all extremities. Blood chemistry showed blood urea nitrogen 34 mg/dl, creatinine 0.9 g/dl, albumin 4.5 g/dl, aspartate aminotransferase 78 u/l, alanine aminotransferase 189 u/l, gamma glutamyl transpepitadase 160 u/l, alkaline phosphatase 146 mg/dl, total bilirubin 1.8 mg/dl, direct bilirubin 0.5 mg/dl, ammonia 47 ul/l, international normalized ration 0.91, and blood FK5506 level 7ng/ml. Serum immunoglobulin G was positive against herpes simplex virus 1, Epstein [[name]] virus and cytomeglaovirus, but neg against herpes simplex virus 2. Immunoglobulin M was neg against Epstein [[name]] virus and CMV in serum. The testing for Campylobacter Jejuni was not performed. Lumbar puncture revealed that the cerebrospinal fluid looked xanthochromic with red blood corpuscles 0/11^3, while blood cells 1/mm3, protein 358 mg/dl, glucose 88 mg/dl, lactic acid 2.7 mEq/l, and opening pressure of 25 cm cerebrospinal fluid. Cerebrospinal fluid venereal disease research lab slide test, gram stain, cyptococcal antigen, and cytology were neg. Herpes simplex virus, CMV, and Epstein [[name]] virus DNA were not detected by polymerase chain reaction test. Electrodiagnostic studies showed prolonged distal latencies and absence of late responses in all extremities. The component muscle action potential were reduced throughout with absence of component muscle action potential in the proximal tibial and peroneal nerves bilaterally. The conduction velocities were reduced in demyelination range in the median nerves bilaterally. There was a conduction block in median nerves bilaterally, in right ulnar and in right tibial nerves. These findings were consistent with acute inflammatory demyelination polyneuropathy. Shortly after admission, the pt was Intubated for airway protection and started on IV immunoglobulin 0.4 g/kg/[[name]] for three [[name]]s without significant improvement. Plasma exchange was not considered because of the pts hemodynamic status. His hospitalization course was complicated by the development of ischemic colitis secondary to dysautonomia, for which he under went subtotal colectomy. The pt expired three weeks after admission from septic shock and acute renal failure. The authors note although the temporal relationship between GBS and influenza vaccination is suggestive of causal relationship, it does not fully prove it.	Y				Y	0			N				Electrodiagnostic studies showed prolonged distal latencies and absence of late responses in all extremities. The component muscle action potentials were reduced throughout with absence of component muscle action potential in the proximal tibial and peroneal nerves bilaterally. The conduction velocities were reduced in demyelination range in the median nerves bilaterally. There was a conduction block in median nerves bilaterally, in right ulnar and in right tibial nerves. These findings were consistent with acute inflammatory demyelination polyneuropathy. Due to size limitation of the lab comments field, the complete reported lab findings are entered in the single case comments field.	UNK	UNK	FK506, Prednisone.		The pt had a history of hypertension and alcoholic liver cirrhosis, for which he underwent orthotopic liver transplantation six months prior to admission. He denied any precedent episodes of diarrhea, nausea, vomiting, or other gastrointestinal or upper respiratory illness.		200603086	1						1	Alanine aminotransferase increased; Aspartate aminotransferase increased; Asthenia; Autonomic nervous system imbalance; Blood alkaline phosphatase increased; Blood bilirubin increased; Blood urea increased; CSF test abnormal; Colitis; Demyelination; Dysphonia; Gamma-glutamyltransferase increased; Guillain-Barre syndrome; Inflammation; Polyneuropathy; Quadriplegia; Renal failure; Sepsis; Shock	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0267627	11/22/2006	CA	83.0	83		F	11/14/2006	Seriousness criteria other medically significant (OMIC). Initial information received on 11/9/06 from a health care professional. An 83 year old female pt received a dose of Fluzone SV 2006 2007 USP, lot number U2186AA, administered IM in the left deltoid on 10/30/06. Within 24 hours, the pt developed right side facial numbness. On 11/2/06, the pt developed right side facial paralysis and was seen in a physicians office the following day. No treatment was given. At the time of this report, the pt had not recovered from the events.				Y					N	10/30/2006	10/31/2006	1		UNK	UNK			The patient has a past medical history of congestive heart failure (CHF), hyperlipidemia, hypertension, breast cancer, hypothyroidism and osteoporosis.  She has no known allergies.  She had no illness at the time of vaccination on 30/Oct/2006.		200603021	1						1	Facial palsy; Hypoaesthesia	FLU3~SANOFI PASTEUR~U2186AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267636	11/22/2006	PA	86.0	85		F	11/16/2006	Pt presented with cellulitis to right upper arm, painful and warm to touch. Given Rocetin 1gm IM and a prescription for Augmentin 875 mg One tab twice a day for 10 days.				Y					U	11/15/2006	11/15/2006	0	NONE	OTH	OTH	Hydroxyzine, Glurotrol XL, Neurotin, Klorscon, Pramactrol, HCTZ, Aspirin, Vicodin.	NONE	Iodine 11/04 had cellulitis after Pneumovax inj, HTN, Diabetes, High Cholesterol.	Cellulitis~Pneumo (Pneumovax)~~83.00~In Patient		1						1	Cellulitis; Injection site pain; Injection site reaction; Injection site warmth; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U2281AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0320F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0267637	11/22/2006	NY	54.0	53		F	11/17/2006	Itching arms legs progressed 11/17/06 arms cleared, to left scapula and down hands. Prednisone.									Y	11/15/2006	11/15/2006	0		PUB	OTH	ASA, Niacin	NONE				1						1	Pruritus	FLU3~SANOFI PASTEUR~U2272AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267638	11/22/2006	NY	37.0	37		F	11/14/2006	Hives, itching of arms, legs.									Y	11/13/2006	11/13/2006	0	NONE	PVT	OTH		NONE	Allergy			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2272AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267639	11/22/2006	OR	58.0	57		F	10/24/2006	On 10/11/06 at about 3:30 pm. I became nauseated. I had diarrhea and vomiting and a low grade fever 100-101 on 10/12, as well as a achy joints and a headache. I stayed on clear fluids, tea for 48 hours and recovered. I've reacted to previous flu shots in past.									Y	10/10/2006	10/11/2006	1	NONE	PUB	UNK		NONE	NONE		OR200626	1						1	Arthralgia; Diarrhoea; Headache; Nausea; Pyrexia; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69240~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267640	11/22/2006	OR	50.0	49		F	10/24/2006	HA generalized joint pain, pain behind eyes, sensitivity to light, increased nasal secretions, chest tightness, generalized fatigue SX last 2 1/2 days. Began evening of vaccine. Missed 5 hours of work on 10/12/06.									Y	10/10/2006	10/10/2006	0	NONE	PUB	PUB	Premarin	NONE	NONE		OR200625	1						1	Arthralgia; Chest discomfort; Eye pain; Fatigue; Headache; Photophobia; Rhinorrhoea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69240~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267650	11/22/2006	OK	6.0	6		M	11/22/2006	The flu vaccine was given at about 3pm 11-14-06. The following morning complained about his arm hurting.  The arm was itchy, hard, hot, and red about 3 inches around the site of the injection.  This lasted for about 48 hours, during which time the parent took the child to the doctor and the doctor asked for a report to be filed.				Y					Y	11/14/2006	11/16/2006	2	none	UNK	UNK		none	none			1						1	Injection site erythema; Injection site hypersensitivity; Injection site induration; Injection site pain; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U2262AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267652	11/22/2006	OH	28.0	28		F	11/22/2006	Approximately 90 minutes after vaccine given, Reported headache, feeling hot, diaphoretic, denied difficulty breathing, skin appeared sl red, denied itching, Patient reports took 50 mg benadryl, 10 minutes later jaw felt tight, tongue swelling, and throat started to swell. Went to ER.				Y					Y	11/21/2006	11/21/2006	0		UNK	UNK						1						1	Erythema; Feeling hot; Headache; Hyperhidrosis; Throat tightness; Tongue oedema	FLU3~SANOFI PASTEUR~U2280AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267655	11/22/2006	KY	62.0	62		F	11/21/2006	11:15am burning in stomach, clammy/sweaty, vomiting x3, numbness on arms and hands (all within 20 minutes).				Y					Y	11/20/2006	11/20/2006	0	EKG, Chest xRay (normal) taken 11/20/06 about 2:30 PM	UNK	UNK	Evista, Lexopro, ASA, vitamin	none	Sulfa and codine allergy (sulfa-hives) (codine-makes ill).		KY2006033	1						1	Abdominal discomfort; Cold sweat; Hyperhidrosis; Hypoaesthesia; Vomiting	FLU3~SANOFI PASTEUR~U2239AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267657	11/22/2006	MI	1.02	1	.0	F	11/22/2006	local reaction, erythema.									Y	11/22/2006	11/22/2006	0		UNK	UNK						1						1	Injection site erythema; Injection site reaction	FLU3~SANOFI PASTEUR~U2191AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~0530R~3~IM~RL~HIB (PROHIBIT)~1|MMR~MERCK & CO. INC.~0497f~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~b08655c~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1064f~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0267660	11/22/2006	MS	24.0	24		F	11/22/2006	Severe facial itching and swelling around the mouth. 12/22/06 Received medical records from hospital which reveal patient seen 11/20/06 with complaints of swollen itchy lips & painful chin day after flu vax 11/15/06.  Patient had taken Benadryl w/o relief.  Lips were noted to be reddened, had papules & were swollen.  No respiratory distress.   FInal DX: allergy to FluMist vaccine.				Y					Y	11/15/2006	11/15/2006	0		MIL	MIL			Allergies: amoxicillin, cephalosporins, PCN Illnesses: galactorrhea, hemorrhoids, conjunctivitis, hearing loss, dysfunction of lumbar region, sacral ankylosis			1						1	Pruritus; Rash papular; Swelling	FLUN3~MEDIMMUNE VACCINES, INC.~500430~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0267661	11/22/2006	MA	60.0	60		M	11/22/2006	Shaking chills, fever up to 101F, blood shot eyes, arm capillaries seemed to be raised on bilteral arms only.  Took benadryl 50 mg at 5:30, Symptoms reduced by 11:30 pm, resolved by 11/22 AM.									Y	11/21/2006	11/21/2006	0	none	UNK	UNK	pravicol, dioxin, singular	none	HTN, asthma, chol,			1						1	Chills; Ocular hyperaemia; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U2254AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267662	11/22/2006	NC	15.0	15		F	11/22/2006	Student developed a rash and had some complaints of itching.									Y	11/22/2006	11/22/2006	0		UNK	UNK		none	allergies			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~u2244aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267663	11/22/2006	TN	35.0	35		M	11/22/2006	Intermittent swelling and itching.									U	11/07/2006	11/08/2006	1	none	UNK	UNK		none	none			1						1	Pruritus; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua221ba~3~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0267665	11/22/2006	KS	33.0	33		F	11/22/2006	Increased temperature (101 F), Increased WBC (22.7), pain/redness at injection site. Both vaccines were administered at the same site.  12/4/06 Received medical records from hospital which reveal patient admitted 11/8/05 for uncontrolled IDDM (on insulin pump), transient loss of consciousness, gastroparesis & history of closed head injury(CHI).  Neuro consult done but not included with records received.  Had at least 2 other episodes of transient LOC due to hypoglycemia unawareness. New dx of pineal cyst which Neuro did not feel was contributory.  No further episodes & was d/c to home 11/12/05   Final Dx: IDDM, uncontrolled; transient loss of consciousness secondary to hypoglycemia; pineal cyst.							Y		Y	11/09/2005	11/11/2005	2	WBC 22.7 on 11/11/05 at 0810 Temp of 101 on 11/11/05 at 0450 LABS: WBC 8.8 w/max 22.7,  lymphs 5, absolute neutros 20, abs monos 1.36.  .  All c/s were neg.  EEG was WNL. CT of sinuses revealed minimal mucosal thickening in max sinuses bilaterally.  CXR was WNL. gastric emptying study was WNL.	UNK	UNK		Uncontrolled Diabetes Mellitus Type 1	augmentin and erythromycin PMH: depression, GERD, gastroparesis, MVA 1997 w/CHI & coma requiring rehab, bilateral shoulder pain since MVA, urinary incontinence & right sided weakness since MVA, ca of cervix, s/p TAH w/BSO.  Anxiety, muscle spasms			1						1	Diabetes mellitus; Impaired gastric emptying; Injection site erythema; Injection site pain; Loss of consciousness; Nuclear magnetic resonance imaging brain abnormal; Pyrexia; White blood cell count increased	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~9570903~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0267666	11/22/2006	KS	0.0			F	11/22/2006	Began itching approximatly 5 minutes after receiving the flu shot.				Y					Y	11/16/2005	11/16/2005	0		MIL	UNK						1						1	Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA154AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0267668	11/22/2006	PA	0.26	0	.3	F	11/22/2006	Medical Assistant administered influenza vaccine to 3 month old.									U	11/22/2006				UNK	UNK						1						1	Medication error	FLU3~SANOFI PASTEUR~u2187aa~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267670	11/22/2006	UT	62.0	62		F	11/22/2006	The patient developed a 3x5cm area on her upper right arm that appeared to look like a blister after receiving a pneumococcal vaccine on 10/26/06.  It was debrided and diagnosed as a cellulitis and given an Rx for Augmentin 1000 mg bid x 10 days on 10/30/06. The wound did not improve much, so she was then given Rocephin 1 gm IM x 1 on 10/31/06. She was seen again on 11/01/06 and had improved somewhat, so no additional treatment was done at that visit.  She was then seen again on 11/09/06 and given an Rx for Augmentin 875 mg bid x 10 more days.  She was seen again on 11/21/06 for a follow up and there was not much improvement.  There was no redness or enduration but the area was a large open wound with crust down to the adipose tissue.  She was diagnosed with an open wound, diabetic ulcer and we were able to get her in that day to a general surgeon for evaluation and treatment.				Y					N	10/26/2006	10/27/2006	1	None	UNK	UNK	Benazapril 20/12.5 2 qd, Actos 30 mg qd, Metformin 1000 mg bid, Glipizide 10 mg bid, Fosomax q week, Zocor 40 mg qd	none	Type II diabetes, HTN, hyperlipidemic, cataracts, arthritis			1						1	Cellulitis; Injection site reaction; Injection site vesicles; Skin ulcer	FLU3~SANOFI PASTEUR~U2240AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0485F~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2609AA~1~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0267671	11/22/2006	CA	3.0	3		M	11/22/2006	Marked swelling of R thigh (site of injection)with erythema and warmth.  Marked irritability and agitation.				Y					U	11/19/2006	11/20/2006	1		UNK	UNK	none	none	unknown. pt adopted at 15 months			1						1	Agitation; Injection site erythema; Injection site swelling; Injection site warmth; Irritability	DTAP~UNKNOWN MANUFACTURER~~UNK~IM~LL~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~2~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0267673	11/22/2006	WA	32.0	32		M	11/22/2006	Fever at night (flu vaccine administered at 9am that day). Chills, sweating.  Felt very tired.									Y	11/13/2006	11/13/2006	0		UNK	UNK		None.				1						1	Chills; Fatigue; Hyperhidrosis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0267701	11/22/2006	MN	59.0	59		M	11/21/2006	Recent history of end stage renal disease. On dialysis for last 3 weeks. Discharged from hospital 10/24/06. 3-4 days ago, developed gradual increase in weakness, fatigue. Not able to get up without assistance. 11/08 intubated. 11/14 trache placed.  1/2/07 Received medical records from hospital which reveal patient admitted 3 times: 10/13/06-10/19/06 -- Final Dx: renal failure, secondary to acute tubular necrosis; hx of DVT & PE; & Wolff-Parkins-White syndrome; anemia; metabolic acidosis & hyperkalemia, resolved. Procedures during that hospitalization included: US guided percutaneous biopsy or right kidney 10/13/06; MRA of abdomen 10/17; placement of dialysis cath & initiation of dialysis 10/18/06. LABS: creatinine 7.3 (up from 2.9 2 wks prior during hospitalization for chest pain). 10/21/06-10/25/06 -- Final Dx: Abdominal & back pain; tachyarrhythmia tx w/ablation.  10/31/06-11/30/06.  Intubated on 11/8/06 due to resp muscle weakness.  Numerous episodes of plasmapheresis; numerous courses of IV immunoglobulin.  Feeding tube & trach placed 11/14/06. FINAL DX: Guillain Barre Syndrome believed to be due to flu vax; renal failure, dialysis dependent; fevers, secondary to vancomycin; profound weakness; & history of DVT & PE.  Information received from annual follow up indicates patient has not recovered. Only able to move eyes & jaw. Vent dependent. Patient died 1/26/07. Developed multiple myeloma. Had renal failure prior to this. In chronic atrial fibrillation. Per 60 day follow up: Continued to have minor improvements in neurologic function, including some neck flexion and some purposeful function of leg muscles, prior to his death due to other complications, on 1/26/07. He was a dialysis pt. who had bouts of C. difficile, dysrhythmia and ventricular tachycardia during the last days of life.				Y	Y	30				10/19/2006	10/27/2006	8	HgB 9.2, platelets 334, Creat 4.9, INR 2.1 on 11/01.  LABS: bronch 11/15/06, c/s no growth. Seronerve biopsy 11/23/06.  CT of chest, abd & pelvis 11/21/06.	PVT	PVT	Nephro caps, Vicodin, Phoslo, Diltiazem, Levenox, Coumadin,	Chronic Kidney Disease	Acute renal failure on dialysis, Wolff Parkinson white syndrome.  PMH: atrial fib; acute tubular necrosis dx by kidney bx 10/13//06; Wolff-Parkinson-White s/p ablation; left DVT 3/05; PE 6/05; hx of STDs			1						1	Abdominal pain; Anaemia; Arrhythmia; Asthenia; Atrial fibrillation; Back pain; Biopsy; Biopsy kidney; Blood creatinine increased; Blood product transfusion; Bronchoscopy; Catheter placement; Chest pain; Clostridial infection; Computerised tomogram; Death; Dependence on respirator; Dysstasia; Endotracheal intubation; Fatigue; Haemoglobin decreased; Hyperkalaemia; Hypokinesia; Laboratory test; Metabolic acidosis; Multiple myeloma; Muscular weakness; Plasmapheresis; Platelet count normal; Prothrombin time normal; Pyrexia; Renal failure; Renal tubular necrosis; Surgery; Tachyarrhythmia; Tracheostomy; Ventricular tachycardia; Wolff-Parkinson-White syndrome	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA206BA~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0267702	11/22/2006	PA	10.0	10		M	11/22/2006	11/14/06 FluMist given, 11/16 c/o right neck ache, felt hot to mom, PE examination tender right posterior cervical. T/C neg. 11/19 expresses yellow nasal discharge (hx recurrent sinusitis), Rx given. 11/20 developed rash. 11/21  admitted to hosp DX HSP.   3/15/07 Received medical records from hospital which reveal patient admitted 11/21/06-11/22/07 after experienced rash & HTN 8 days s/p flu vax.  Exam revealed fatigue, swollen left foot, shotty cervical lymph nodes in neck, diffuse peripuric rash & torticollis.  Had mild abdominal pain.  Admitted renal consult done. Rheum consult recommended & renal f/u scheduled as outpatient. FINAL DX: Vasculitis, likely Henoch-Schonlein Purpura (HSP); nephritis; HTN. Per 60 day follow up: Dx with HENOCH-SCHONLEIN purpura doing well.					Y	2			Y	11/14/2006	11/16/2006	2	LABS: BUN 20, Uric acid 6.0, WBC 10.1, neutros 75, lymphs 15.  ESR 50.  IGA 4143+ blood in urine, urine protein 100, urine RBC 63	PVT	PVT		Resolving URI	PMH: Developed pallor & swollen lymph nodes 1 day s/p vax & was seen by PCP & found neg for strep.  Seen in ER on 11/15 for facial swelling & stiff neck.   HTN (148/97) noted at that time.  11/17 developed copious yellow nasal d/c & developed rash on 11/17 which continued to worsen.  Had URI s/s w/fever & diarrhea end of October. FAMILY Hx: psoriasis, SLE, gout			1						1	Feeling hot; Henoch-Schonlein purpura; Neck pain; Rash; Rhinorrhoea; Sinusitis; Tenderness	FLUN3~MEDIMMUNE VACCINES, INC.~500441P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0267703	11/22/2006	MD	51.0	51		F	11/22/2006	None Stated.									Y	11/22/2006	11/22/2006	0		MIL	MIL	NONE	NONE				1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2259AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267707	11/22/2006	NH	2.0			F	11/22/2006	No adverse event, pt given FluMist, should have had vaccine. Had Flu vaccine 1yr ago no Adverse effect.														PVT	UNK		NONE	NONE		NH0618	1						1	Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~500439P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0267676	11/24/2006	IL	70.0	70		M	11/24/2006	Patient received Influenza and Pneumococcal vaccinations in left shoulder at 9am. At 5pm he developed weakness, dizziness and fever to 102F. He had terrible pain in the shoulder not so much at the injection site but in the joint itself. He had shakes and chills. He continued to feel faint after lying down and continued to have fever. He had pain in the left shoulder and also in both knees. Paramedics were called. Blood pressure in the field was as low as 52/40 but improved with fluid bolus to 118/58. He was brought to the ED and given Tylenol, Motrin, Stress-dose steroids, Morphine and Dilaudid.He became hypotensive again in the hospital and was transferred to intermediate care on dopamine. All symptoms improved within 48 hours. Sepsis was ruled out.  Hospital MR received revealing  70 yr old male admitted to the hospital for sudden onset of fever, weakness, dizziness, and shoulder pain approximately 8 hours after his Pneumovax and Flu vax.  PE: Febrile with rectal temp. up to 104'F.  Initially hypotensive then improved with bolus IV fluids.  Decreased ROM in left shoulder.  Pain in left shoulder and knees. Otherwise normal exam.  Treated with dopamine for BP support, Rocephin, Zosyn,and stress dose steroids. Discharged feeling well and asymptomatic after 48 hours. Impression: Resolved hypotension, arthralgias, fever 2' to AE from pneumococcal/influenza immunizations (serum-sickness like).				Y	Y	2			Y	11/04/2006	11/04/2006	0	Urine and blood cultures were negative WBC the morning following onset of reaction was 21.0 with 18.9 neutrophils, 0.5 lymphocytes and 1.5 monocytes (K/microliter). LABS and DIAGNOSTICS: UA showed 20-40 ketones, WBC's on admission 7.9 which rose to 21.0 the following day, Blood cultures negative.  CXR shows known lung nodules. Kidney stones seen on abdominal X-ray. EKG NSR with 1' AV block. Otherwise unremarkable.	UNK	UNK	Prednisone, Methotrexate, Flutamide, Folgard, hydrocortisone cream, fluconazol cream.		PMH: Rheumatoid arthritis, recurrent kidney stones with lithotripsy and stenting September 2006,, E. coli urosepsis 6/2006, pneumonia 1/2006, right pulmonary nodule-stable.  Allergies: NKDA			1						1	Arthralgia; Asthenia; Atrioventricular block; Chills; Dizziness; Hypotension; Pyrexia; Serum sickness; Shoulder pain; Tremor; Urine abnormality; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0267679	11/24/2006	WI	46.0	46		F	11/24/2006	Patient vaccinated on 11/15/06.  Returned to clinic two days later (11/17/06) with pain, swelling, erythema, and tenderness.  She stated the pain started immediately after receiving the vaccine, and the other symptoms were noticed once she had returned home.  She reported a history of numerous flu shots without problems and denies any allergies including to eggs.  The patient was directed to use ice packs and was given a five day course of dicloxicillin 500mg QID due to the severe tenderness and erythema.  The patient was called the following morning (11/18/06) and reported the erythema, redness, and swelling had all improved.  She was told to complete the course of antibiotic and to follow up in clinic on 11/20/06 (Monday) if she still had problems, which she did not need to do.				Y					Y	11/15/2006	11/15/2006	0		UNK	UNK	Aleve, Flexeril, meclizine prn	Right trapezius muscle spasm and neck pain/strain				1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2212AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267680	11/24/2006	TX	8.0	8		F	11/24/2006	Unsure if any relation to vaccine, but in case. . . Since the night of 10/23/06, the day she got Flumist, she has had sparse episodes of heart-racing associated with clammy skin and shortness of breath.  We are now working her up for SVT.  No such problems before then.										10/23/2006	10/23/2006	0	The day she got the FluMist, she was diagnosed with nasopharyngitis. A CBC was done with WBC of 11,300, 57%segs, 33%lymphs.  Rapid Strep -.  She was also put on a decong/antitussive and stayed on it for one week following the visit.  She has had several heart-racing episodes despite being off the cough/cold med for three weeks.	UNK	UNK	Amoxillin and Pancof EXP were prescribed on the same date, both used with prior illnesses with no complications.  Pancof was stopped within a week of the 10/23 visit, but spells of heart-racing have still occurred.	cough, rhinorrhea and body aches.  Dr dx'd pt with nasopharyngitis	none			1						1	Cold sweat; Dyspnoea; Heart rate increased; Nasopharyngitis	FLUN3~MEDIMMUNE VACCINES, INC.~500389D~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0267681	11/24/2006	PA	23.0	23		F	11/24/2006	Allergic (anaphylactoid) reaction resulting in acute shortness of breath with wheezing occuring within 5 to 10 minutes post injection, light-headedness resulting in loss of balance and falling. Treated with methylprednisolone IV, famotidine IV, Anzemet IV, diphenhydramine IV and albuterol/ipratropium inhalation treatments x4.				Y					Y	10/25/2006	10/25/2006	0	Non	UNK	UNK		None	Asthma. Allergies= salicylates, old bay, cinnamon, tree nuts. (now influenza vaccine)			1						1	Anaphylactoid reaction; Dizziness; Dyspnoea; Fall; Hypersensitivity; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua210aa~5~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0267684	11/24/2006	CA	65.0	65		F	11/24/2006	My arm turned red and became very swollen & painful. I could not stand to touch the arm from shoulder level to elbow. The pain interfered with sleep the night of 11-22. I was very weak and tired the evening of the 22nd and all day on the 23rd, so tired that I slept 3x during the day & had to go to bed at 6:30 p.m. Now, it's 3 days later & some swelling persists. I did not seek medical help.									U	11/22/2006	11/22/2006	0		UNK	UNK	atenolol, HCTZ, thyroxin	none	Allergies - pollen, dust mites, other substances			1						1	Erythema; Pain; Sleep disorder; Somnolence; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0267685	11/25/2006	TN	57.0	57		F	11/25/2006	Redness with about 2-3 inches diameter welts on arm around injection site day after injection; redness with welts covered about 6 inches diameter second day after injection.  Second day after injection fever of 102.0, severe headache in top and back of head, and blood pressure of 168/88.  Fever lasted for approximately 36 hours, began about 48 hours after injection.									Y	11/16/2006	11/18/2006	2		UNK	UNK	IV Immunoglobulin	Mastoid infection; cellulitis, post-superior vena cava thrombosis	autoimmune demyelinating poloyneuropathy; allergy to adhesive tape; allergic to sulfa			1						1	Blood pressure increased; Headache; Injection site erythema; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0267688	11/26/2006	PA	43.0	43		F	11/26/2006	The evening of the vaccine I developed a sickening pain in the back of my neck that was worst at the base of my skull and radiated up over my head. I was nauseous and just felt really sick. Within a couple days I was feeling worse and no otc pain meds helped. I saw my family doctor who ordered blood tests and examined me. I was told that I may be having an adverse reaction to the vaccine and told to wait it out. My symptoms got worse and I became very dizzy and lightheaded. I felt as though I would pass out but it never progressed to passing out. I just felt on the verge of it all of the time. I returned to my doctor and was examined. At this point I had a sore throat with ear pain and congestion with face and teeth pain. I was given zithromycin for a sinus infection and but/apa/caf for the pain in my neck and head. I was given nasonex to help with the ear pain. Again I was told it was probably just a reation to the vaccine and I needed to wait it out. I went back to work after missing 2 days one week and 1 day the next week. I still had the pain in my neck up into my head and still felt dizzy and lightheaded. On Tuesday November 21, I was at work and became more dizzy and lightheaded, clammy, and flushed and just felt that I was going to collapse. I was taken to the ER and from there was admitted to the hospital. I was in the hospital for 4 days. I was given an MRI/MRA of the brain, cat scan of my head,US of the carotid arteries, echo of my heart, placed on a telemetry moniter and given blood tests. I was given Midrin for pain and that didn't take it away. Voltaren did relieve me for approx 2 hours with each dose but I could only have that 2xdaily...so we alternated the midrin with tylenol and the votaren.I was given zofran for nausea. My tests came back normalexcept for mild anemia but my symptoms did not go away.The doctors did not feel the anemia would cause any of my symptoms.  I was seen by an ENT spec. and a neurologist. Neither felt that I was having ear or brain issues. I was given antivert for the dizziness and flexeril for the pain in my neck and discharged after all results from tests were in and I had seen all the consulted doctors. I have been home for 2 1/2 days now and I am feeling worse as far as the head/neck pain and dizziness. I will follow up with my family doctor this week. I just want to cry all the time and don't feel steady enough to shower alone and definitely can't drive. I don't even want ot ride in a moving car. I have missed an additional 4 days of work now and don't feel any improvement.  While hooked up to the telemetry moniter I had sinus tachycardia with activity and a few times just while laying in bed. My temp is normally below 98 degrees and while in the hospital it ranged from 98-99.8  My heart feels like a fish flopping out of water at times and I get a little sob when it does that.  1/18/07 Received medical records from hospital which reveal patient admitted 11/21-11/24/06 for light headedness, headache w/nausea, dizziness for approx 2 weeks & recent URI w/otitis media & ruptured TM 1 week prior to onset of symptoms.  Only abnormal on exam was horizontal nystagmus.  Admitted for r/o labyrinthitis, CVA, complex migraine, aneurysm. FINAL DX: near syncope; headache; dizziness; depression; & anemia. The vaccine triggered an MS exacerbation.  I was diagnosed with MS in May 2007   If I had not had the vaccine.... I may not have had an exacerbation for years if ever.  I wish I had chosen not to have the vaccination.  5/13/2010 Follow up: I continue to have the pain at the base of my skull. I lost my job and some days I can't get out of bed. This has been a nightmare for me and my family.				Y	Y	4	Y		N	11/08/2006	11/08/2006	0	MRI/MRA-normal Cat scan of head/normal Echo of heart/normal Telemetry moniter/Sinus Tachycardia w/activity/HR160's US of carotid arteries/normal Hemmocult testing/no blood in stool Urine test/normal Blood tests/ mild anemia, slightly elevated wbc, slightly elevated platelets, slightly elevated eosinophils Pulse ox in the 90's LABS: CT of head was WNL.  Carotid US, MRI, MRA & CXR were all WNL.  WBC 7.0, H/H 10.9/34.3	UNK	UNK	zoloft, diclofenac, prilosec on daily basis	None	allergic to penicillen, morphine 1 week prior to admission...given zithromax..in case my syptoms were from a possible sinus infestion. osteoarthritis in pelvic region PMH: osteoarthritis, GERD, depression.  Recurrent OM w/TM ruptures.  Tinnitus.	had flu-like symptoms for weeks and ended up with optic neuritis in my left eye for months~Influenza (Seasonal) (no brand name)~		1						1	Activities of daily living impaired; Cardiac telemetry abnormal; Cold sweat; Computerised tomogram head; Dizziness; Dizziness; Dyspnoea; Ear pain; Echocardiogram normal; Eosinophil count increased; Facial pain; Flushing; Haematocrit decreased; Haemoglobin decreased; Impaired driving ability; Impaired work ability; Malaise; Multiple sclerosis relapse; Nausea; Neck pain; Occult blood negative; Pharyngolaryngeal pain; Platelet count increased; Respiratory tract congestion; Sinus tachycardia; Sinusitis; Toothache; Ultrasound Doppler; Ultrasound scan normal; Urine analysis normal; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0267689	11/26/2006	IL	70.0	70		F	11/26/2006	Pt reported pain throughout arm where Pneumovax was administered.  She also reported swelling throughout same arm and underarm, along with fever and chills.  Vaccine was administed at 1pm, signs/symptoms started around 6:30 pm, and lasted approximately two days according to patient.									Y	11/03/2006	11/03/2006	0	none	UNK	UNK	none known	None	None			1						1	Chills; Oedema peripheral; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2274AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0003F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267690	11/26/2006	KY	6.0	6		M	11/26/2006	Within 36 to 48 hours of nasal FluMist vaccine, my son started complaining of stomach pain and runny nose.  This progressed to Upper Respiratory Congestion, Hoarseness, Loss of Voice, and some difficulty breathing within 48 more hours.				Y					U	11/21/2006	11/22/2006	1		UNK	UNK	None	None	None			1						1	Abdominal pain upper; Dysphonia; Dyspnoea; Rhinorrhoea; Upper respiratory tract congestion	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0264138	11/27/2006	TX	81.0	81		F	11/21/2006	Information has been received from a pharmacy intern concerning an 81 year old female with sulfa allergy who of 05-Oct-2006 (initially reported as 04-Oct-2006) at 10:49 AM was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (0.5 ml) (lot#651399/0486F), intramuscularly in the left arm.  Concomitant therapy that day and time included a first dose of influenza virus split virion 3v vaccine inactivated (Fluarix), intramuscularly in the right arm.  There was no illness at the time of vaccination. Subsequently, the patient awoke that night on 05-Oct-2006 with a rash on abdomen, neck and under her breasts and on neck with itching.  The patient used diphenhydramine HCL (BENADRYL) orally and cream topically for symptoms.  The pharmacist advised patient to call her physician.  It was reported that the patient was prescribed methylprednisolone sodium succinate (SOLUMDROL).  It was also reported that the patient has received pneumococcal 23v polysaccharide vaccine more than 5 years ago. a long time ago, and had no adverse reaction.  The reporter considered the patient's experience to be an other medical event.  Additional information has been requested. (OMIC)				Y					N	10/05/2006	10/05/2006	0		OTH	PVT			Concurrent conditions: sulfonamide allergy		WAES0610USA05608	1						2	Pruritus; Rash; Pruritus; Rash; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA202BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0486F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA20281A~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~2|PPV~MERCK & CO. INC.~0486F~1~IM~LA~PNEUMO (PNEUMOVAX)~2|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA202BA~2~~UN~INFLUENZA (SEASONAL) (FLUARIX)~3|PPV~MERCK & CO. INC.~04868F~2~~UN~PNEUMO (PNEUMOVAX)~3	USA	Emergency room visit	Influenza
0266001	11/27/2006	IL	61.0			M	11/17/2006	After flu shot, he developed left Bell's palsy and left hearing difficulty, left facial ???? sensation.									N				MRI Scan and Brain.	UNK	UNK						1						2	Corneal reflex decreased; Facial palsy; Hearing impaired; Hemiparesis; Lacrimation increased; Neuritis; Speech disorder; Swelling; Tenderness; Facial palsy; Hearing impaired	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|UNK~UNKNOWN MANUFACTURER~~UNK~~UN~VACCINE NOT SPECIFIED (NO BRAND NAME)~2	USA		Influenza
0267600	11/27/2006	VA	49.0	49		F	11/24/2006	Vaccine given 11/10/06, 6:30 am. Raised rash under arm pit occurred 48 hrs later, noticed indentation of armpit 96 hrs later, and experienced deltoid muscle atrophy 1 W/L later.									N	11/10/2006	11/12/2006	2		PVT	UNK	Tamoxifen	NONE	Keflex and Tylenol with codeine.		E13665	1						2	Rash erythematous; Skin atrophy; Muscle atrophy; Rash; Rash maculo-papular	FLU3~SANOFI PASTEUR~U2275AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2275AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0267691	11/27/2006		30.0	30		F	11/27/2006	7cm x 4.5cm erythematous patch at site of injection on left upper arm.  Left earache, nasal congestion, pain and pruritus at injection site.										11/25/2006	11/27/2006	2		MIL	MIL	none	none				1						1	Ear pain; Injection site erythema; Injection site hypersensitivity; Injection site pain; Nasal congestion; Pruritus	FLU3~SANOFI PASTEUR~U2199AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267704	11/27/2006	CA	3.0	2	.6	F	11/22/2006	Fever 101.8 several hours after vaccination.										11/21/2006	11/21/2006	0		PVT	UNK	Bactrim	Urinary tract infection				1						1	Pyrexia	FLU3~SANOFI PASTEUR~05176EA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1008F~2~IM~LL~HEP A (VAQTA)~1	USA		Influenza
0267706	11/27/2006	VA	51.0	50		F	11/17/2006	T101, inflamed at site and warm to touch, 11/15 usual shot pain, 11/16 slight pain still, 11/17 inflamed an temp went to patient first DX with cellulitis antibiotics given 10 d supply.				Y					U	11/15/2006	11/17/2006	2		OTH	OTH		NONE				1						1	Cellulitis; Injection site inflammation; Injection site pain; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U2215AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~391F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0267740	11/27/2006	NM	68.0	67		F	10/17/2006	Pain, swelling, redness, inflammation, fever, chills, malaise. Admitted to ER 11/11/06. Admitted to a Med center 11/11/06 for 2 days. IV Antibiotics blood cultures, X ray. Rehab dressing change, wound care every 2 days beginning 11/15/2006.  1/9/07 Received medical records from hospital which reveal patient admitted 11/11-11/13/06 with an abscess of the right deltoid which started 2 days s/p flu vax at local pharmacy flu clinic.  Temp was 99.5 in ER.  An I&D was performed while in the ER & approx 100-150 ml of grayish pus was expelled.  Then patient was admitted for IV antibiotics.  Progressed well & was d/c to home with wound care clinic visits & oral antibiotics.				Y	Y	2			Y	10/31/2006	11/04/2006	4	LABS: WBC 25,200 on admit with neutros 93.3, lymphs 2.7, bands 10.3, monos 2.0.  WBC on d/c was 9.0  Xray of right arm revealed extensive inflammatory changes of soft tissues.  Wound culture grew Group F beta strep.  Blood c/s were neg.	OTH	UNK						1						1	Chills; Erythema; Inflammation; Malaise; Oedema; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~236AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0267742	11/27/2006	MD	22.0	22		F	11/17/2006	Vomiting, fever 14 1/2 hours after receiving influenza vaccine. Continued with vomiting and admitted to hospital 11/14 PM with dehydration.  12/8/06 Received medical records from hospital which reveal patient admitted 11/14/06 for abdominal pain & refractory vomiting.  Treated w/IVF & antiemetics as well as protonix.  Improved & had no pain or vomiting on d/c to home 11/15/06. Final Dx: gastroenteritis./ss				Y	Y	2			Y	11/13/2006	11/14/2006	1	LABS: CBC was WNL.  K low on admit.  Abd CT scan showed tiny amount of free fluid in pelvis.  Abd series was nonspecific.  Abd sonogram showed dilated intrahepatic duct.	OTH	PUB		Upper respiratory infection, sore throat, slight cough				1						1	Abdominal pain; Dehydration; Gastroenteritis; Pyrexia; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72001~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0267743	11/27/2006	AZ	50.0	50		M		Numbness and tingling in both hands, headache, back pain. Hypertension 240/150. Developed respiratory failure and received mechanical ventilation, plasma pheresis and IVIG.  12/12/06 Received medical records from hospital which reveal patient admitted 10/30/06 for numbness, tingling, back pain, SOB, nausea, vomiting & headache for 3 days.  Originally patient seen in urgent care facility but with BP of 240/150 was transferred to ER.  Initial presentation in ER also had HTN of 226/126.  Admit dx: severe HTN; new onset DM; low potassium.  Admitted to ICU.  Respiratory status deteriorated & patient intubated.  Neuro, pulmo, cardio & nephro consults done for GBS & plasmapheresis when IVIG was ineffective.  Patient was trached 11/10, feeding tube & PICC line placed, bilateral chest tubes placed 11/15.  No D/C summary available at this time.   D/C on 11/20. Final Dx: GBS.			Y		Y	21				10/18/2006	10/27/2006	9	LABS: WBC 8.3, glucose 227, K 2.7.  CT of head was WNL; CT of chest showed bilsteral posterior infiltrates.  EKG abnormal. Bronchoscopy 10/31 revealed copious amounts of purulent secretions; repeat bronchoscopy on 11/10 revealed continued purulence.  Guided LP done 11/1.  EMG/NCS done revealed mixed results GBS. MRI of brain done 11/3 revealed hyperintensity within the left parietal lobe thought to be hypertensive encephalopathy, vasculitis or demyelination. CSF showed WBC 0, glucose 60, protein 76, cultures neg.	UNK	UNK			PMH: none significant but patient admitted to blood tinged sputum x 1 mo prior to admit.			1						1	Back pain; CSF test abnormal; Diabetes mellitus; Guillain-Barre syndrome; Headache; Hypertension; Hypoaesthesia; Laboratory test abnormal; Paraesthesia; Respiratory failure; Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70737~UNK~~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70737~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Life Threatening,Hospitalisation	Influenza
0267743	11/27/2006	AZ	50.0	50		M	11/21/2006	Clinic administered a flu vaccine to patient on 10/18/06 after he had appropriately filled out a consent form (provided in Spanish) - indicating he had no contraindications for receiving the flu vaccine. The vaccine was paid for by his employer. The clinic did not see this individual again after administering his vaccine.										10/18/2006				OTH	PVT						1						2	Back pain; CSF test abnormal; Diabetes mellitus; Guillain-Barre syndrome; Headache; Hypertension; Hypoaesthesia; Laboratory test abnormal; Paraesthesia; Respiratory failure; Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70737~UNK~~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70737~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0267744	11/27/2006	WA	53.0	53		M	11/13/2006	(OMIC) 53 year old healthy male was given two vaccines (influenza and Dtap) on 10/25/2006. He developed a severe headache on 10/29. The headache persisted and he subsequently developed diplopia on 11/1. He had mild nausea, photophobia, neck tightness and fatigue. He had a normal.  Confirmed with reporter that Tdap (Adacel) was given, not Dtap. MR received revealing a 53 year old who was seen 3 days s/p Tdap and flu vax. with c/o right sided neck tightness, photophobia, nausea  and headache.  Pt. developed diplopia 3 days post vax.  PE: WNL with the exception of measurements of the degree of deviation of his eyes c/w a right 4th cranial nerve palsy upon opthalmologic exam. Using Motrin and Tylenol for h/a.  DX: New onset right 4th cranial nerve palsy associated with flu shot and headache.									Y	10/25/2006	10/29/2006	4	Head MRI was normal 11/03/06, 4th cranial nerve palsy (by ophthalmologist) on 11/08-09, TSR, fasting glucose and hemoglobin A1C were normal on 11/09/2006. Labs and Diagnostics: MRI shows no acute intracranial findings except an incidentally noted developmental right frontal venous anomaly. Labs WNL.	UNK	UNK	No regular meds.		PMH: Nephrolithiasis, atypical chest pain, tinea versicolor.  Allergies:  IV contrast, eggs as a child.			1						1	Diplopia; Fatigue; Headache; Musculoskeletal stiffness; Nausea; Paralysis; Photophobia; Vascular anomaly	DTAP~SANOFI PASTEUR~C2572AA~UNK~IM~UN~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2193AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267745	11/27/2006	TX	51.0	51		F	11/13/2006	Employee given a flu shot at 1030 AM on 11/13/06. She was staying for observation about 15 minutes. I began to feel tingly and flush. Checked B/P and it was 180/88. Employee stated she didn't feel well. Rash noted on arms. Continued to feel sick and was given Benadryl 50mg PO now.  B/P at 1040 AM 148/70 and at 1045 shot up to 180/90. Discharged morning has to check and O2 at 2 hours given. No complaints of difficulty breathing noted. BP at 1115 shot up to 200/100 and employee transported via ambulance to hospital. Employee given Decadron IV. Continue to have reaction on 11/14/06 and went back to doctor. She was given Decadron IV, Medrol dose pack, Zyrtec and Benadryl PRN and advised to stay home for 5 days. Diagnosis: anaphylaxis sustained reaction from flu shot.					Y				Y	11/13/2006	11/13/2006	0		UNK	UNK						1						1	Anaphylactic reaction; Flushing; Hypertension; Malaise; Paraesthesia; Rash; Blood pressure increased; Hypoaesthesia; Nausea; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70738~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70738~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Hospitalisation	Influenza
0267746	11/27/2006	TN	38.0	37		F	11/22/2006	Local adverse reactions on arm i.e. swelling at injection site, red spots, feverish in arm, patient better in 3-4 days.									Y	11/08/2006	11/09/2006	1		OTH	PVT						1						1	Injection site swelling; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F600311~1~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0267747	11/27/2006	KY	59.0	59		F	11/21/2006	Patient flu shot 11/16/2006 on LD.  Patient reports 11/17/06 left arm was swollen at the injection site.  Are was red and warm and the size of her hand.  Patient reports running fever but did not take temp.  Patient reports top part of stomach felt like it was on fire.  Patient reports  passing out around 7pm that evening.  Patient called to report symptoms on 11/21/06 and reports feeling fine today.									Y	11/16/2006	11/17/2006	1		OTH	PUB		NONE	Allergy to CODEINE and NIACIN (cholesterol medicine)			1						1	Erythema; Injection site swelling; Injection site warmth; Loss of consciousness; Pyrexia	FLU3~SANOFI PASTEUR~U2184AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267748	11/27/2006	OH	45.0	45		F	11/17/2006	11/14 pm-welts on legs-itchy-resolved in 24 hours.  11/15 swollen lower lip.									Y	11/14/2006	11/14/2006	0	NONE	PVT	UNK		NONE	asthma-on medication			1						1	Pruritus; Swelling face; Urticaria	FLU3~SANOFI PASTEUR~U2204AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~0674F~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0267749	11/27/2006	MA	0.18	0	.2	F	11/20/2006	Patient received Rotateq on 11-13-06 and 5 days later had bilious emesis. Seen in ED, had (-) upper gastrointestinal.  Also with diarrhea. Also has milk protein sensitivity.				Y					Y	11/13/2006	11/18/2006	5	Upper Gastrointestinal	PVT	UNK		Milk protein sensitivity	Milk protein sensitivity			1						1	Diarrhoea; Vomiting	DTAP~SANOFI PASTEUR~01774BA~1~~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~01067~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE037AA~1~~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B08657K~1~~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0695F~1~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0267750	11/27/2006	OH	44.0	43		F	11/21/2006	Vaccine was administered at approx 9:45am on 11/13/06. at 12:50pm pt came back to the office and reported bad itchiness on hands and soles of feet, spread to legs and face. Areas were all erythematic. 50mg of Diphenhydramine (1cc) Deep IM in right hip given. The itchiness had started at approx 12 noon. By 1:10 pm S/S were subsiding by 1:30 pm they resolved.				Y					Y	11/13/2006	11/13/2006	0		PVT	PUB	Reyataz, Norvir, Truvada, Vicodin, Valtrex.	NONE	Codeine			1						1	Erythema; Pruritus	FLU3~SANOFI PASTEUR~U2286AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267751	11/27/2006	NJ	4.0	4		F	11/21/2006	Received 4 yr old immunizations on 11/14/06. 11/16/06 swelling and redness in left arm came in for appt 1/17/06 DX with left arm cellulitis treated with Omnicef.				Y					Y	11/14/2006	11/16/2006	2		PVT	PVT						1						1	Cellulitis; Injection site erythema; Injection site oedema	DTAP~SANOFI PASTEUR~C2521AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2247AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1030~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0876F~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0267752	11/27/2006	NJ	14.0	13		F	11/21/2006	Rec'd flu vaccine 11/07/2006. Woke up 1/08/2006 arm red, swollen, warm to touch. Seen in office diagnosed with cellulitis treated with Keflex.				Y					Y	11/07/2006	11/08/2006	1		PVT	UNK			RAD			1						1	Cellulitis; Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U2247AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267753	11/27/2006	NJ	4.0	4		F	11/21/2006	Rec'd 4 yo immunization on 11/13/06 developed fever 11/14/06 and red arm seen in office diagnosed with cellulitis treated with Keflex.				Y					Y	11/13/2006	11/14/2006	1		PVT	PVT		NONE				1						1	Cellulitis; Injection site erythema; Pyrexia	DTAP~SANOFI PASTEUR~C2521AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2247AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1030~5~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~033F~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0267754	11/27/2006	NJ	4.0	4		M	11/21/2006	Rec'd flu vaccine 11/16/06 that evening developed sore arm with increased redness, increase swelling. Seen in our office 11/17/06. Diagnosed with cellulitis and prescribed Omnicef.				Y					Y	11/17/2006	11/17/2006	0		PVT	UNK						1						1	Cellulitis; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U2247AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267755	11/27/2006	MI	81.0	81		F	11/13/2006	Received Td and Flu on 11/08/06 right arm. On Fri 11/10/06 in the evening one noticed 50 cent hard deep lump, on outer back of right arm. A couple inches from the shot area warm to touch slight discolored skin, lump seems to be resolving and is less hard. Enc to Seek medical attention if increased redness and swelling.									Y	11/08/2006	11/10/2006	2		PUB	PVT		NONE	Rehab in left arm.			1						1	Injection site erythema; Injection site induration; Injection site mass; Injection site warmth; Skin discolouration	FLU3~SANOFI PASTEUR~U2247AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~AVENTIS PASTEUR~U1731AA~UNK~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0267756	11/27/2006	ME	31.0			F	11/21/2006	4 days after Flu shot developed neck stiffness, nausea, vomiting, headache neck pain. Treated by PCP IV pain meds IV fluids.				Y					Y	11/03/2006	11/06/2006	3	Blood test	PUB	OTH						1						1	Headache; Musculoskeletal stiffness; Nausea; Neck pain; Vomiting	FLU3~SANOFI PASTEUR~U22018A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267757	11/27/2006	AZ	25.0	25		F	11/20/2006	Systemic SX with fever, myalgia, tachycardia, hypertension, near syncope, large local reaction at site of administration 4x6 cm Rt arm.				Y						11/17/2006	11/18/2006	1	11/18/06 WBC 16.6, RBC 4.07, Neutrophils 92.3, Lymphocyte 4.4.	PVT	UNK			Allergic Rhinitis (aero allergens) asthma with increase IgE.			1						1	Dizziness; Hypertension; Injection site reaction; Laboratory test abnormal; Myalgia; Pyrexia; Tachycardia; White blood cell count increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71829~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0089F~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0267758	11/27/2006	OH	0.51	0	.5	M	11/21/2006	Large hives on whole body. Benadryl given for 5 days. No other symptoms or respiratory distress.				Y					Y	10/24/2006	10/28/2006	4	None	PUB	PUB	Tylenol	None	None			1						1	Urticaria	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B070AA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2175AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE869AA~3~IM~LL~HIB (ACTHIB)~1	USA	Emergency room visit	Influenza
0267759	11/27/2006	NE	37.0	36		F	11/09/2006	within 10-15 minutes of injection my mouth was dry and the back of my throat started to constrict. Patient had difficulty swallowing and some wheezing. Minimal itching to chest. Benadryl 50mg taken po and symptoms went away in 1 hour.									Y	11/02/2006	11/02/2006	0		OTH	PVT	None	None	None	similiar symptoms as this time~Influenza (Seasonal) (no brand name)~1~35.00~In Patient		1						1	Dry mouth; Dysphagia; Pruritus; Wheezing	FLU3~SANOFI PASTEUR~U2246AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267760	11/27/2006	FL	83.0	82		M	11/17/2006	Patient states having pain in arm and shoulder for 6 days.  Thinks may have had a fever the first night.  Taking nonsteriodal anti-inflammatory drugs.									U	11/09/2006	11/09/2006	0	None	PUB	PUB		None	None reported			1						1	Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~CH70277~3~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0740R~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267765	11/27/2006	OH	1.04	1	.0	F	11/20/2006	Developed red rash at injection site day after administration. Subsequently developed widespread maculopapular rash.									Y	11/06/2006	11/07/2006	1	None	PUB	PVT	None	question beginning of otitis				1						1	Injection site rash; Rash macular	DTAP~SANOFI PASTEUR~U1635CA~4~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U72175BA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0521F~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0267766	11/27/2006	WA	56.0	55		F	11/20/2006	Patient had bruising of left upper arm where injection occurred. Bruise lasted for 2 weeks. Went away for a couple days and returned again.									U	10/16/2006	10/17/2006	1	None	OTH	PVT	None	None	None			1						1	Contusion; Injection site reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70621~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267768	11/27/2006	WI	46.0	45		F	11/22/2006	Woke up AM of 11/16/06 with chills, fever, L forearm soreness and a red raised area on the L Deltoid. L deltoid had a burning discomfort, worse with range of motion or particularly with lifting. No itching, no shortness of breath, any other symptoms were negative.									Y	11/14/2006	11/16/2006	2	None	PVT	PVT	Lexapro 20mg daily, Calcium, Vaztrex 500 mg as needed, Advil 800mg	None	Allergic rhinitis, depression, hyperlipidemia			1						1	Chills; Injection site erythema; Myalgia; Pyrexia; Skin burning sensation	FLUX~UNKNOWN MANUFACTURER~U1870AA~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0749F~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267769	11/27/2006	CA	48.0	47		F	10/26/2006	Onset fever: 10/19/06 5:30am 103F; duration: 3hours. By 10/20 6:30am; 99F. Left arm pain at 9:15pm on 10/19/06, warmth, inflammation, lump at site.									Y	10/18/2006	10/19/2006	1	None	PVT	PVT	Advil as occasion arrives	None	None			1						1	Feeling hot; Injection site inflammation; Injection site mass; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA220BA~3~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0267771	11/27/2006	CA	46.0	46		F	10/18/2006	Injection received at 10/18/06 09:45 with no problems. 3 hours after vaccine suddenly developed large swelling, itching and redness at injection site.									Y	10/18/2006	10/18/2006	0	None	PVT	PVT	None	None	None			1						1	Erythema; Pruritus; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLuA220BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0267772	11/27/2006	NJ	60.0			M	11/17/2006	Severe cramping, chills, fever.				Y					Y					PVT	UNK	None					1						1	Chills; Muscle spasms; Pyrexia	FLU3~SANOFI PASTEUR~70868~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267773	11/27/2006	GA	2.0	2	.3	F	11/19/2006	Pt received 0.5 ml Flu vaccine and she should have received Fluzone.									Y	11/16/2006				PUB	PVT	NONE	Ear infection	NONE			1						1	Medication error	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71643~1~~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267774	11/27/2006	MI	48.0	47		F	11/15/2006	MMR administered SC in left arm 11/13/06, returned 2 days later 11/15/06. Slight redness, warm to touch, size of 50 cent piece reaction. Referred to MD treated with Benadryl 1 steroids PRN, no known allergies.				Y					Y	11/13/2006	11/14/2006	1		PVT	PVT	Herbal	NONE	Mitrol valve prolapsed, Lumbar spondylosis.			1						1	Injection site erythema; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71641~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|MMR~MERCK & CO. INC.~0425F~UNK~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0267775	11/27/2006	NY	59.0	59		F	11/21/2006	Pt was vaccinated 11/15/06, 11/17/06 at 2am started with headache, chills, aching joints and temp 102-103, 11/16/06 swelling at site of injection.									Y	11/15/2006	11/16/2006	1	NONE	PVT	UNK		NONE	Chronic Pain RSD			1						1	Arthralgia; Chills; Headache; Injection site oedema; Pyrexia	FLU3~SANOFI PASTEUR~U2271AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267776	11/27/2006	CA	1.09	1	.1	M	11/21/2006	Mom started childs lip became swollen about 1-2 hours after receiving vaccination. 11/28/06 Received medical records from provider which reveal patient developed swollen lips approx 1 hour s/p vax along with emesis.  Developed a rash on outside of cheek & inside cheek swelling.  Referred for allergy testing & no further flu shots/new foods were to be given until testing completed.									Y	11/20/2006	11/20/2006	0	Dr seen pt on same day vaccinated.	PVT	PVT		NONE				1						1	Face oedema; Rash; Vomiting	FLU3~SANOFI PASTEUR~U2220BB~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267777	11/27/2006	NY	6.0	5		F	11/20/2006	Arm at shot reddened after 24 hours then hives around area.									Y	11/13/2006	11/14/2006	1	Been tested for allergies	PVT	PVT	Zyrtec, Flonase, Singulair, Flovent, Albuterol	NONE	Testing by allergist.			1						1	Injection site erythema; Urticaria	FLU3~SANOFI PASTEUR~U2254AA~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267778	11/27/2006	NY	9.0			F	11/20/2006	Arm at shot reddened, hard after 24 hours continued.									Y	11/13/2006	11/14/2006	1	Will be tested for allergies	PVT	PVT	Zyrtec, Singulair, Albuterol, Flonase					1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U2254AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267780	11/27/2006	NJ	5.0	5		M	11/22/2006	Fever d 4-5 post immunizations T 101-103 degrees. Visual hallucinations d 4-5 with and without fever - sleeping and garbe headache d 3-5				Y					Y	11/14/2006	11/18/2006	4	NONE	PVT	PVT	NONE	NONE	Asthma			1						1	Hallucination; Headache; Pyrexia	FLU3~SANOFI PASTEUR~V2248AA~3~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1025F~2~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0267783	11/27/2006	OH	50.0	50		F	11/14/2006	Redness and swelling at site.  Warm to touch.  Returned in 24 hours swollen left arm no redness underarm only at injection site.										11/13/2006	11/14/2006	1		PUB	OTH	NONE	NONE	No known Allergy			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Oedema peripheral	FLU3~SANOFI PASTEUR~U2248AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267798	11/27/2006	NY	5.0			F	11/21/2006	Seriousness criteria other medically significant (OMIC). Initial report received on 11/16/06 from a health care provider. A fiver year old female pt, with a history of asthma, had received a right deltoid injection of Fluzone SV 2006-2007, lot number unk, on 11/6/06. Initially the pt had redness and a lump at the site. Four to five day post vaccination, the pts entire upper arm was swollen but not red or discolored. The event required a doctor visit. There was no illness at the time of vaccination. At the time of this report, the pt had not recovered.				Y					N	11/06/2006				PVT	PVT	Singulair		The pt had a history of asthma and takes singulair.		200603125	1						1	Injection site erythema; Injection site mass; Injection site oedema	FLU3~SANOFI PASTEUR~~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267800	11/27/2006	PA	47.0	47		F	11/24/2006	I was called by pts coworker stating she developed a high fever the day after the vaccine was administered and was hospitalized for possible encephalitis. 11/27  received update from coworker that doctors did not feel she had reaction to vaccine.  2/6/07 Received medical records from hospital which reveal patient experienced fever, sore throat & diarrhea s/p flu shot.  Admitted 11/16-11/22/06.  ID & GI consults done & w/u revealed c diff.  Improved on Flagyl & was d/c to home on Flagyl for 2 more weeks. FINAL DX: clostridium difficile diarrhea, hx of recent flu shot & hx IBS.					Y				U	11/15/2006			stool + for c. diff	OTH	UNK			IBS			1						1	Pyrexia	FLU3~SANOFI PASTEUR~U2250AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0267801	11/27/2006	IN	46.0	46		F	11/27/2006	Patient states she awoke around 2:30 am with itching on her face and back.  When she got up that morning for work she noticed hives on her face and back.  Denies any other symptoms.									Y	11/20/2006	11/21/2006	1		UNK	UNK		None	None			1						1	Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA242AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0267802	11/27/2006	NJ	42.0	42		M	11/27/2006	Vaccinated wednesday, symptoms of exhaustion and dizziness appeared friday night/saturday morning. Symptoms of exhaustion continue today [monday].										11/22/2006	11/24/2006	2		UNK	UNK	zyrtec, Advair, Prevacid	two days after finishing round of Cipro for sinus infection	plant pollen allergies			1						1	Dizziness; Fatigue	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0267803	11/27/2006	ID	2.0	2	.4	F	11/27/2006	My daughter was given the flu shot at around 11:45 a.m. on Saturday, November 25.  Within hours, she broke out in hives on her face, stomach and chest. She has been extremely irritable for the last two days.									U	11/25/2006	11/25/2006	0		UNK	UNK		Had fever earlier in the week before immunization				1						1	Irritability; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0267804	11/27/2006	CA	60.0	60		F	11/27/2006	Patient received flu vaccine on 11/1 afternoon.  One hour later experienced fleeting nausea.  That same evening after dinner around 7pm, pt had nauasea & vomited once.  At 1am on 11/2, pt woke up vomiting.  She was hospitalized 11/2 to 11/3.  Pt reported chills, had fever 101-103F.  Head CT, CXR & abd X ray were done to R/O obstruction, which were all negative.  Pt was pancultured, and given a dose of IV cefotaxime.  Pt tolerated liquid diet, was ambulating & afebrile on day of discharge.  Pt was discharged on PO Cipro for possible urosepsis.  Final blood & urine cultures all negative.  Pt had no further F/C/N/V.  2/16/07 Received medical records from hospital which reveal patient admitted 11/2-11/3/06 after experienced one day history of malaise, N/V, fevers & chills. Also complained of chest pain radiating to neck intermittently x 1-2 wks.  Temp in ER 101 & was pan cultured.  Tx w/IV antibiotics.  Improved & was d/c home to continue oral antibiotics. FINAL DX: febrile illness w/dysuria, possible UTI vs cystitis.					Y	1			Y	11/01/2006	11/01/2006	0	Blood culture negative.  Urine culture negative.  Head CT, chest X ray & abdominal x ray all negative.  Tox screen negative. LABS: CT head, CXR, abd x-ray were all WNL.  WBC 8.4, neutros 82.1, lymphs 13.3.  Mag 1.5.  EKG was WNL.  Troponin less than 0.04.  Initial H/H 13.3/39.  After hydration H/H was 10/7/31.5.  Blood c/s & Urine c/s were neg.	UNK	UNK	Unknown	None	Codeine & opiate derivatives; gramicidin + neomycin + polymyxin; bacitracin + neomycin + polymyxin. PMH: arthritis, UTI			1						1	Chills; Nausea; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~3~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0267805	11/27/2006	MA	2.0	2	.0	M	11/27/2006	PT DEVELOPED RASH AND FEVER ON 11/22/06, ALSO WITH PHARYNGITIS AT TIME OF VISIT.									Y	11/08/2006	11/21/2006	13	THROAT CULTURE NEG	UNK	UNK	FLUORIDE	NONE	NONE			1						1	Pharyngitis; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U2191DA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~9048F~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0267814	11/27/2006	IL	57.0	57		F	11/22/2006	Red arm red, swollen, hot from shoulder to elbow. Pneumonia shot.  Contacted by phone 11/27/06 took BENADRYL-Improved by Friday 11/24/2006.									Y	11/21/2006	11/21/2006	0		PUB	PUB	Cozaar	NONE	NONE			1						1	Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71832~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0958F~3~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267815	11/27/2006	IL	78.0	78		F	11/27/2006	Temp 103 arm red blotchy, trouble breathing, 24 hours later, discomfort in arm later same day.				Y					Y	11/09/2006	11/10/2006	1	Seen in ER	PUB	PUB		NONE	Pt on oxygen at home.			1						1	Discomfort; Dyspnoea; Injection site erythema; Pyrexia; Rash macular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71832~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0749F~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0267816	11/27/2006	MA	72.0	72		F	11/27/2006	Lips and legs were swollen, even got fever blister swelling went down on 11/25. Rash on shin bone on 11/22, lasted for 3 days. Doctor visit today problems have subsided, only fever blister on lip remains.				Y					U	11/21/2006	11/21/2006	0		OTH	PUB	Multivitamin, and minerals, cozaar		High blood pressure, thyroid conditions.			1						1	Blister; Face oedema; Herpes simplex; Oedema peripheral; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0267817	11/27/2006	VA	2.0	2	.5	F	11/27/2006	Slept more than normal Saturday and Sunday. Monday morning left eye was completely turned in, balance and coordination was off. pediatrician sent us to ER, Diagnosed with Guillian Barre, Ataxia transferred to Hospital, pressure in brain.  5/10/07 Received partial medical records from hospital.  No D/C Summary done.  No labs done.  T/C to medical records to confirm d/c date & request MRI report.   Admitted 11/14/06-11/16/06.  Handwritten medical records very difficult to read but reveal patient experienced crossing of eyes, unsteady gait & excessive sleepiness x 3 days.  Neuro consult done but unable to read it.  Had been seen at outlying hospital & had CT of head & LP done there.  Will request those medical records also. FINAL DX: None given. 5/10/07Received medical records from initial hospital which reveal patient experienced crossed eyes, excessive sleepiness & unsteady gait.  LP done in ER & noted to have less crossed eyes s/p LP.  Transferred to higher level of care. FINAL ER DX: possible GBS; opthalmoplegia; ataxia. Information received from the annual follow up indicated patient had not recovered. Had acute left esoptropia after being given the flue vaccine. She had a medical rectus muscle repair surgery in July 2007. She still has some residual problems with her eye after the surgery. Information received from annual indicates patient had not recovered. Her vision is still impaired, had to have eye surgery, still having regular appts. & MRI. Eyes still cross. Per 60 day follow up: Increased intracranial hypertension, vision loss due to pressure build up, chronic headaches. Follow-up: Sudden eyes crossed, head aches, intracranial hypertension.				Y	Y	4			N	11/09/2006	11/11/2006	2	ER LABS: WBC 10.0, H/H 10/30.7, plt 605, neutros 52, monos 12, ESR 41.  CSF glucose 47, protein 21.1, c/s neg.  Chem specimen hemolyzed, K 5.6, creat 0.1, BUN/creat ratio 140, AST 76 CT scan of head was WNL; Multiple MRIs; Spinal Taps; Blood work	PVT	OTH		None	Birth HX: 35 wk preemie PMH: thallasemia, h/o recurring fevers w/elevated WBC, unknown immunological deficiency. None			1						1	Balance disorder; Blindness; Blood potassium increased; Blood test; Blood urea nitrogen/creatinine ratio increased; Coordination abnormal; Haematocrit normal; Haemoglobin normal; Haemolysis; Headache; Intracranial pressure increased; Lumbar puncture; Neutrophil count increased; Nuclear magnetic resonance imaging; Ophthalmoplegia; Strabismus; Surgery; Visual impairment; White blood cell count normal; Strabismus	FLU3~SANOFI PASTEUR~U2247AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2247AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0267818	11/27/2006	WI		76		F	11/27/2006	On 11/17 was not feeling well.  On the 25th felt really sick, couldn't breath, coughing.  On the 26th went to the doctor and was prescribed ERYTHROMYCIN and feels much better now. Took MUCINEX for cough.				Y					U	11/12/2006				OTH	PUB	AMARYL, Armor natural thyroid, Percocet, Oxycontin, AVAPRO, Vitamin E, Multivitamin, Flax and Fish Oil	NONE	Rheumatoid arthritis in emission, high blood pressure and thyroid problems, shingles			1						1	Cough; Dyspnoea; Malaise	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71215~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0267819	11/27/2006	MN		18		F	11/27/2006	Right arm of injection, right swelling. Treated with ice.									Y	11/24/2006	11/24/2006	0	NONE	PVT	UNK		NONE	Tape, patient with asthma.			1						1	Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72006~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267820	11/27/2006	AR	50.0	50		F	11/13/2006	Woke up early a.m. after Flu shot given-with hands itching- palms, in between all fingers, front of hands as if I had hives.  Checked hands and they were not red, not nay hives.  Itching continued until around 6:00 a.m. at times almost intolerable.  Ran hands under cold water for 30 minutes or so trying to stop the itching.									Y	11/01/2006	11/02/2006	1	NONE	PVT	PVT		NONE	NONE			1						1	Pruritus	FLU3~SANOFI PASTEUR~U2169NA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267821	11/27/2006	CA	57.0	57		M		Dizziness, fever, behavior changes, hoarseness, paleness, weakness, confusion				Y					Y	11/01/2006			Blood work	PUB	PVT	Vicodin, Atanol/Furosimide	NONE				1						1	Abnormal behaviour; Asthenia; Confusional state; Dizziness; Dysphonia; Pallor; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0267823	11/27/2006	NY	39.0	39		F	11/20/2006	35 minutes after immunization, not feeling good. 45 minutes - nausea. That evening vomited 3-4 times. Then chills, body aches, lethargy. After 24 hr sweating and hot. 72 hrs later felt normal.									Y	11/15/2006	11/15/2006	0		PVT	OTH	NONE	NONE	Vicodin			1						1	Chills; Feeling hot; Hyperhidrosis; Lethargy; Malaise; Nausea; Pain; Vomiting	FLU3~SANOFI PASTEUR~U2272AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267824	11/27/2006	NY	49.0	49		M	11/15/2006	Patient was administered 0.5 cc Influenza vaccine IM R deltoid at 12 noon, returned to clinic site 1320 c/o rash itching on R hand/wrist and bilateral on lower jaws. Instructed him the call family physician, go home, take Benadryl. Patient had no overt symptoms of respiratory distress.									Y	11/15/2006	11/15/2006	0		UNK	UNK		NONE	None noted			1						1	Rash pruritic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71210~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267825	11/27/2006	WI	13.0	13		F	11/16/2006	Had Varivax vaccine on 11/14/06. Returned 11/16/06 with a 9.5 cm x 10 cm area of erythema on right arm at site of injection. There was also a 4 cm x 4 cm area of erythema and induration that was tender on palpation. Treated with Duricef 500 mg capsule - 1 capsule bid for 10 days.				Y					U	11/14/2006	11/15/2006	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site induration; Tenderness	FLU3~SANOFI PASTEUR~U2242AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1052F~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0267826	11/27/2006	NC	61.0	60		F	11/16/2006	High fever to 104 18 hours after taking shot. Also erythema, pain, induration of scalp, face and ears that varied in location from day to day. After Solumedrol and Prednisone, sxs slowly improved over next two weeks.				Y					Y	10/25/2006	10/26/2006	1	Increased WBC count, increased platelet count	PVT	PVT	Avapro 150mg, Calcium daily, Evista 60mg		HTN, Hyperlipidemia, Osteopenia			1						1	Erythema; Pain; Platelet count increased; Pyrexia; White blood cell count increased	FLU3~SANOFI PASTEUR~U2218AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267828	11/27/2006	UT	47.0	47		F	11/17/2006	Numbness of mouth, chin, redness of neck and upper portion of chest, no SOB, no hives, sensation of warmth of face and neck. Some swelling of lips - symptoms resolved spontaneously took 25 mg Benadryl at 3:00 pm.									Y	11/17/2006	11/17/2006	0	Patient talked to PMD who advised Benadryl	OTH	OTH	Plavix	S/P repair PDA 5/06	Reports allergy to egg yolks - No reaction previously			1						1	Erythema; Feeling hot; Hypoaesthesia; Swelling face	FLU3~SANOFI PASTEUR~U2271AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267829	11/27/2006	OR	48.0	48		F	11/15/2006	Half hour after injection broke into cold sweat for approx 45 minutes. Then between 6-6:30 pm baseball size knot surrounding injection site. The arm went numb and numbness remained for 1.5 days. Took Benadryl at 7:15 pm and swelling gone by next morning. Only able to lift arm over head after 2 days.									Y	11/09/2006	11/09/2006	0	NONE	OTH	PVT	NONE	NONE	Allergy - Percodan			1						1	Hyperhidrosis; Hypoaesthesia; Injection site mass; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71827~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267830	11/27/2006	FL	53.0	53		M	11/14/2006	About 30 min post vaccination got a call from staff members. Employee waiting to clock in sitting in Bistro. C/o numbness back of throat, dizziness, lips and mouth burning. Weakness bilateral leg.				Y					Y	11/13/2006	11/13/2006	0		UNK	UNK			Arthritis, HTN, Hep C, Hyperlipidemia, Allergic to PCN			1						1	Dizziness; Hypoaesthesia; Muscular weakness; Stomatitis	FLU3~SANOFI PASTEUR~U2254AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267831	11/27/2006	FL		43		F	11/14/2006	Raise red petechiae noted on abdomen trunk. Also red rash welt are over navel area.									Y	11/13/2006	11/13/2006	0		UNK	UNK						1						1	Erythema; Petechiae; Rash; Urticaria	FLU3~SANOFI PASTEUR~U2254AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267832	11/27/2006	MA	21.0	21		F	11/16/2006	Pt c/o being light headed, BP 80/50, P 64, RR 16, Color good, lung sounds clear, no stridor feels her tongue is heavy, this is not visibly swollen, denies chest pain/tightness. Pt placed flat/supine, 911 called, arrival of Paramedic transported to medical center. Pt states through an interpreter that she had peptic ulcers and ran out of meds at 2 weeks ago. This past week she had been vomiting blood.				Y					Y	11/16/2006	11/16/2006	0		PUB	PVT	NONE	Peptic ulcer	Peptic ulcer			1						1	Blood pressure decreased; Dizziness; Haematemesis; Tongue disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA220AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0267840	11/27/2006	AZ	5.0	4		M	11/17/2006	Urticarial lesion noted on Right lower eyelid, behind Right ear, on right shoulder and right upper back. Mild swelling of eyelid in area where urticarial lesion present. No respiratory symptoms, no facial edema, no swallowing difficulty. Advised to take Benadryl and be seen if respiratory symptoms, edema, other concerns.									Y	11/15/2006	11/15/2006	0		PUB	PUB	None	None	None			1						1	Eye swelling; Skin ulcer; Urticaria	DTAP~SANOFI PASTEUR~U1891CA~5~~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2201AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0991~3~~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0147F~3~~LL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|PNC~PFIZER\WYETH~B08657E~1~~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0267842	11/27/2006	NY	79.0	79		F	11/20/2006	Severe soreness & tightening of the throat for a period of about 36 hours.									Y	11/06/2006				UNK	UNK						1						1	Pharyngolaryngeal pain; Throat tightness	FLU3~SANOFI PASTEUR~U2178AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267846	11/27/2006		9.0	9		M	11/15/2006	flu shot given 11/14/06 245pm. Mom called MD 11/15/06 8:20am to report tennis ball sized warm red lump at shot site. Has received flu shot in past without incident. Benadryl and Motrin given seen in office 11/15/06 and 11/16/06 now taking Zyretec. The marked area increased slightly in size 2nd day otherwise no complaints.				Y						11/14/2006	11/15/2006	1		UNK	UNK						1						1	Erythema; Injection site mass; Oedema	FLU3~SANOFI PASTEUR~U2241AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267847	11/27/2006		5.0			F		edema, redness at site. Flu shot given 11/14/06 2:45pm. Mom called doctor 11/15/06 8:20am to report welts at injection site. Patient has received flu shot in past without incident. Benadryl given when seen in office 11/15/06.  11/16/06 now taking Zyrtec.				Y						11/14/2006	11/15/2006	1		UNK	UNK						1						1	Erythema; Oedema; Urticaria	FLU3~SANOFI PASTEUR~U2241AA~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267849	11/27/2006	UT	64.0			M	11/01/2006	After 10 hours after receiving Influezea vaccine, patient complained of confusion and Temp of 103. Treated in ER with Tylenol and observation. Regained coherence and normal temp within 3 hours.				Y					Y	10/28/2006	10/28/2006	0	All labs within normal limits.	UNK	UNK			Has had flu shots in past with no problems. History of Rheumatic fever 1946.			1						1	Confusional state; Pyrexia	FLU3~SANOFI PASTEUR~U2246AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267866	11/27/2006	OR	5.0	5		M	11/13/2006	Hot, red, swollen right arm - Swollen from shoulder to below elbow. Treatment of ORAPRED (oral steroid) and cepnallxin (antibiotic for skin infection).				Y					Y	11/11/2006	11/12/2006	1	NKDA	PVT	PVT						1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLUX~SANOFI PASTEUR~U2166LA~5~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0267870	11/27/2006	PA	4.0	4		F		Erythema left thigh 10 x 11 cm. No treatment in									U	11/17/2006				PVT	PVT		Well child				1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U2245AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1088F~2~~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0267813	11/28/2006	MT	56.0	56		M	11/27/2006	Pt presented to ER ascending leg weakness, tingling, gait ataxia. Admitted after LP, Labs, CT IV immunoglobulin TRSFR to ICU several days later in increased respiratory distress, (higher lever hospital some where else).  2/13/07 Received medical records from hospital which reveal patient experienced numbness & ascending weakness 1 week s/p flu vax.  Went to outlying hospital ER & had LP & neuro eval & dx w/GBS.  Admitted to outlying hospital & Tx w/IVIG but had progressive worsening of symptoms & transferred to this hospital on 11/20/06.  Admit eval revealed speech difficulty, significant LE weakness, areflexia.  Received additional 5 days of IVIG but continued to worsen.  Was intubated on 11/25.  Plasmapheresis x 3 was done w/o significant improvement.  Trached on 11/20.  Had intermittent fever & atelectasis while hospitalized & was on multiple antibiotics.  Approx 2 weeks prior to d/c on 1/25/07, strength began to return & was able to be weaned off vent though cough was still poor.  Developed decubitus ulcers as complication of immobility.  Transferred to Rehab on 1/25/07. FINAL DX: Guillain Barre Syndrome secondary to flu vax; staph aureus pneumonitis; e. coli, Klebsiella pneumonitis; decubitus ulcer.			Y	Y	Y					11/06/2006	11/14/2006	8	LABS: LP done at initial hospital revealed WBC 13, protein 47 & normal glucose.  No EMG/NCS was done.	PVT	OTH	Paccione, Lortab, Atacand, Tramadol.		PMH: chronic back pain; chronic shoulder pain secondary to rotator cuff problems; paroxysmal atrial fib; left knee surgery; appendectomy; kidney stones; obesity; HTN			1						1	Asthenia; Coordination abnormal; Gait disturbance; Paraesthesia; Respiratory distress	FLU3~SANOFI PASTEUR~U2186AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0675F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0267880	11/28/2006	MD	8.0	7		F	11/28/2006	May have had a virus before had vaccine. Had a runny nose then had full blown flu with runny nose, headache, cough and stomach ache. Had low grade fever. Took 4 days after had vaccine for symptoms to occur. Dr did not give meds.									Y	10/23/2006	10/27/2006	4	None	OTH	PUB	None	reports runny nose mild by mom				1						1	Abdominal pain upper; Cough; Headache; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~S00438P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0267881	11/28/2006	MN	63.0	63		F	11/28/2006	Had pneumonvax given on L deltoid area. Not painful during administration. Below shot area patient developed swelling and large indurated patch consistent with urticaria. No other systemic symptoms. No hard on forearm.   symptoms- treat with Benadryl and Zantac if not (hot/painful), Medrol dose pak									U	11/27/2006	11/27/2006	0	None	PVT	UNK	see attached list. not attached.					1						1	Injection site induration; Swelling; Urticaria	FLU3~SANOFI PASTEUR~U2202AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0619F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267882	11/28/2006	SD	52.0	52		F	11/28/2006	Patient had rash start to right arm evening of 11/15 then became hot to touch, painful and itchy. Came to clinic 11/17 was given Rocephin 1gm IM and started on Keflex 500mg every 10 hours for 10 days.				Y					Y	11/15/2006	11/15/2006	0		PVT	PVT	Synthroid, baby aspirin	viral upper respiratory infection	chronic obstructive pulmonary disease, hypothyroid			1						1	Feeling hot; Pain; Pruritus; Rash	FLU3~SANOFI PASTEUR~U21675A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0267883	11/28/2006	SD	75.0	75		F	11/28/2006	Cellulitis by that evening. In office next day for treatment. Rocephin 1gm IM given. Patient started on Keflex 500 mg every day for 10 days. Went to acute care 11/28 received another shot of Rocephin.				Y					Y	11/21/2006	11/21/2006	0		PVT	PVT	Proventil, Albuterol Nebs	None	chronic obstructive pulmonary disease, osteoporosis, Left upper lung lobectomy, increased cholesterol, history sinus tachycardia			1						1	Cellulitis	FLU3~SANOFI PASTEUR~U21675A~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0749F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0267884	11/28/2006	VA	65.0	65		F		As doctor inserted needle in the deltoid Right arm and began to give pneumonia vaccine there was a leakage between the needle and hub; therefore client did not get full dose. Spoke with CDC said to repeat dose now.										11/22/2006			None	UNK	OTH	None	None	High blood pressure			1						1	Vaccination complication	FLU3~SANOFI PASTEUR~U2256AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0485F~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267885	11/28/2006	VA	1.02	1	.0	F	11/28/2006	Thrombocytopenia following MMR injection.										11/03/2006	11/25/2006	22	CBC Platelets <100,000 (2 times). Referred to hematology today.	PVT	PVT		None	None			1						1	Laboratory test abnormal; Thrombocytopenia	FLU3~SANOFI PASTEUR~U2247AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~1123F~1~~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08646F~4~~LA~PNEUMO (PREVNAR)~1	USA		Influenza
0267886	11/28/2006	NC	31.0	31		F	11/07/2006	Patient complained of itching-9:06am 11/7/06; 11/7/06 9:28am client complained of shortness of breath to co-workers. First alert team notified and responded. At 9:06am given by mouth Benadryl 25mg given.  At 9:28am Benadryl 50mg IM left arm: Epi 0.5cc SQ Right arm given. Transported via stretcher to ER.				Y					Y	11/07/2006	11/07/2006	0		PUB	PVT		None	no known drug allergies or food allergies			1						1	Dyspnoea; Pruritus	FLU3~SANOFI PASTEUR~U2286AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267887	11/28/2006	NC	59.0	58		F	11/20/2006	General aching all over 2 days. Splotchy areas L arm above elbow.									Y	11/17/2006	11/18/2006	1		PUB	UNK		None	None			1						1	Pain; Rash maculo-papular	FLU3~SANOFI PASTEUR~U2278AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0352F~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267888	11/28/2006	WA	31.0	30		F	11/22/2006	Approx 25 hours after flu shot was received, developed itchy rash over all body. As time went on, it worsened to bumps and redness (11/1/06 about 2am). Went to ER at 0230am 11/1/06. Treated with meds with symptoms resolved almost immediately.				Y					Y	10/30/2006	10/31/2006	1		PUB	PVT		None	No know drug allergies, positive PPD, negative CXR 1/21/03			1						1	Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA206AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0267890	11/28/2006	OR	59.0	59		F	11/22/2006	11/8/06 - Right side back of neck, swollen lymph. On or around 11/16, shins started hurting after walk. Left foot around toes hurting. Then noticed swelling of feet then knees, then right foot and ankles. Now notices feet and hands swollen in AM and can no longer wear rings. No fever; just ache.									N	11/03/2006	11/16/2006	13		PUB	PUB	Synthroid; Premarin; Nasonex	NONE	Allergic to bee stings			1						1	Lymphadenopathy; Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~U2252AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0813R~1~IM~RA~HEP A (VAQTA)~1|MMR~MERCK & CO. INC.~0616F~UNK~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TD~AVENTIS PASTEUR~U1879BA~UNK~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1|TYP~BERNA BIOTECH, LTD.~3001030~1~PO~MO~TYPHOID LIVE ORAL TY21A (VIVOTIF)~1	USA		Influenza
0267899	11/28/2006	KS	0.0	5		M	11/28/2006	Patient receive Fluarix on 22 Nov 06.  Macular erythema developed within 3 days with no induration at site of vaccination on left deltoid.  Patient complained of itching but not pain.  Better today (per mother) than yesterday.  Provided reassurance and hydrocortisone cream for symptomatic treatment.				Y					Y	11/22/2006	11/26/2006	4	None	UNK	UNK		None				1						1	Injection site erythema; Pruritus; Rash macular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA219BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0267900	11/28/2006	ND	43.0	43		F	11/28/2006	Rash 24 hour after administration.  Rash on chest neck and face.  MD prescribed predizone 40 times one wk and antihistamine at H.S.				Y					U	11/08/2006	11/10/2006	2		UNK	UNK	nuva ring, trazadone 100 mg					1						1	Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500431p~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0267901	11/28/2006	TN	20.0	20		F	11/28/2006	1.5 hrs after getting flu shot, incision scar approx 9cm from vaccination site noted by pt to be more swollen than usual and bumpy.  MD notes scar tissue at incision site.  Incision is 3 months old and this is her first injection in that arm since.									U	11/28/2006	11/28/2006	0	n/a	UNK	UNK	none	none	scar from surgical incision L upper arm			1						1	Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0267902	11/28/2006	NC	26.0	26		F	11/28/2006	26 y/o female dental hygienist presented to the HC on 11/1/2006 for evaluation of left shoulder inflammatory lump, swelling, redness, and pain.  The patient had received Tdap vaccination into the left shoulder and inactivated influenza into the right shoulder on 10/30/2006 at Hospital as part of the hospital's recent immunization drive. The symptoms in the left shoulder started within 5-6 hours after Tdap vaccine receipt. No other systemic or allergic symptoms reported.				Y					Y	10/30/2006	10/30/2006	0	None.	MIL	MIL	None	None	None			1						1	Injection site erythema; Injection site mass; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TDAP~SANOFI PASTEUR~C255CAA~UNK~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0267903	11/28/2006	AZ	29.0	29		F	11/28/2006	I RECEIVED MY FLU & PNEUMONIA SHOTS FROM MY DR.S NURSE AROUND 10:30AM. 11/22/06 AROUND 8PM THAT EVENING I HAD SEVERE PAIN IN RIGHT ARM WHERE I HAD THE PHEUMONIA SHOT. IT KEPT GETTING WORSE. I HAD PAIN ON THE SIDE OF MY CHEST AND BREAST AS WELL. I PAGED MY DOCTOR,HE SAID HE HADN'T HEARD OF SUCH A REACTION BEFORE, AND TO KEEP ALTERNATING A HOT COMPRASS & COLD ON MY ARM, AND TAKE SOME ALEVE. ON 11/23/06 MY ARM WAS STILL IN PAIN, I TOOK IBUPROFEN, PUT HEAT & COLD ON IT ALL DAY. IN THE AFTERNOON I STARTED FEELING EXHAUSTED, A LITTLE SICK TO MY STOMACH, AND WAS STILL IN PAIN. I TOOK A NAP FOR A FEW HOURS, ATE A LITTLE DINNER, & TOOK MORE IBUPROFEN & BENADRYL. MY ARM WAS STARTING TO GET RED FROM WHERE THE SHOT WAS ADMINISTERED. AT NIGHT I EXPERIENCED CHILLS, MUSCLE CRAMPS, A FEVER OF 102 DEGREES, & MY ARM STILL HURT. ON  11/24/06 FEVER BROKE, I FELT A LITTLE EXHAUSTED BUT BETTER. MY ARM STILL IN PAIN, DEVELOPED A LARGE (BIGGER THAN AN APPLE)RED WELT. 11/25/06 THE WELT ON MY ARM GREW LARGER & TRAVELED MORE AROUNG MY ARM. 11/26/06 THE WELT ON MY ARM WRAPPED AROUND & UNDER NEAR MY ELBOW BUT WASN'T HURTING AS MUCH. I FELT SO MUCH BETTER THAN I DID DAYS BEFORE. 11/27/06 THE WELT HAS FADED FROM RED TO PINK AND ONLY FEELS LIKE MUSCLE SORENESS. 11/28/06 MY ARM JUST A LITTLE SORE, LITTLE PINK ALMOST COMPLETLEY FINE.									Y	11/22/2006	11/28/2006	6		UNK	UNK	ALBUTEROL, ADVAIR, NASONEX, WELLBUTRIN SR 150MG, YASMIN	NONE	ASTHMA			1						1	Breast pain; Chest pain; Chills; Fatigue; Injection site erythema; Injection site pain; Muscle spasms; Pyrexia; Stomach discomfort; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0267904	11/28/2006	IL	81.0	81		M	11/28/2006	progressively weaker; no mental status change physician diagnos; Guillian-Barre. MR received from hospital stay revealing an 81 yr. old man who presented to the ER with worsening, progressive weakness in his lower and upper extremities several days after receiving flu shot. HPI: Pt. had several episodes of being unable to get up from toilet or out of chair due to leg weakness. Became unable to use walker due to weakness in his arms. Admitted to hospital for diagnosis.  A plueral effusion was noted and treated with thoracentesis. Patient progressed to dysphagia requiring PEG tube palcement. Due to worsening respiratory failure he was placed on a ventilator and trached 6 days after admission. DX: Guillian-Barre. MR received from vax. provider. No new COSTARTS, but received date of vax and date of AE (submitted). Received fax with Manufacturer Chiron Lot # 69480.					Y	14			Y	10/18/2006	11/03/2006	16	LABS and DIAGNOSTICS:Sputum and pleural fluid analysis (+) for a high number of inflammatory cells, Sed rate high at 46, PT high at 14.9-18.4, PTT elevated x2 at 46.0 and 39.1.Serum glucoses generally in mid 100's to 200's with occ. reading above 300. ANA (+), other labs WNL or C/W end stage renal disease. Nerve Conduction Studies demonstrate moderately severe peripheral neuropathy with mixed axonal and demyelinating features. Transthoracic echocardiogram was essentially normal with Left ventricular ejection fraction of 55% to 65% and mild aortic valvular regurgitation.	UNK	UNK	Meds: Nephrocaps, Amaryl, Midodrine, Phos-renal, Simvastatin, and doxorubicin.	none	PMH: End stage-renal disease, Kaposi's sarcoma, hyperlipidemia, diabetes mellitus, anemia, pleural effusion. Allergies: Cipro and Benadryl.			1						1	Antinuclear antibody positive; Asthenia; Blood glucose increased; Dysphagia; Guillain-Barre syndrome; Laboratory test abnormal; Neuropathy; Pleural effusion; Prothrombin time prolonged; Red blood cell sedimentation rate increased; Respiratory failure	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69480~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0267905	11/28/2006	NE	34.0	34		F	11/28/2006	I had my flu shot at approximately 1:30pm.  By 3pm, I had internal pain by my ribs, arm and hand.  By 5pm I was having difficulty breathing.  I called Dr.  and because I was 15 weeks pregnant, she told me I could take 2 Motrin and a hot shower.  By 2am I could not lay down because it made breathing too painful.  I had internal pain in my ribs, back, stomach and had shortness of breath and lots of pain when I inhaled.				Y					Y	11/09/2006	11/09/2006	0	EKG, Chest X-Ray, Leg Ultrasounds, CAT Scan, Bloodwork.  After they ruled out that this was not a life threatening blood clot in my lung, they diagnosed me with pleurisy.	UNK	UNK		N/A	N/A- Pregnant			1						1	Dyspnoea; Pain; Pleurisy; Unintended pregnancy	FLU3~PFIZER\WYETH~~UNK~~RA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0267907	11/28/2006	WV	32.0	31		F	11/27/2006	Loss of muscular use to left side of face. Dx with Bells Palsy per Dr. in ER. DOS 11/16/06- DX Bells Palsy. Left sided facial numbness onset 11/15/26 evening. Left eye felt funny, then numbness started. Unable to wrinkle forehead. Eye will not close. Left facial droop. RX wtih prednisone, acyclovir.				Y					Y	11/13/2006	11/15/2006	2		UNK	UNK		None	N/A			1						1	Facial palsy; Muscular weakness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72002~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0267908	11/28/2006	WI	9.0	9		M	11/28/2006	ONE HOUR AFTER VACCINE, MOM NOTICED A HARD LUMP, APPROX. THE SIZE OF A TENNIS BALL AT INJECTION SITE. IT WAS NOT RED,BUT FELT WARM. NO FEVER. HE COMPLAINED OF TENDERNESS AT THE SITE.									Y	11/26/2006	11/26/2006	0		UNK	UNK						1						1	Injection site mass; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U2212AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267909	11/28/2006	NC	46.0	46		M	11/28/2006	SHOB, sore, red, warm, swollen area of left upper arm that lasted 1 1/2 weeks.									Y	11/04/2006	11/04/2006	0		UNK	UNK						1						1	Dyspnoea; Erythema; Feeling hot; Pain; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA216BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|TTOX~SANOFI PASTEUR~U1624AB~1~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0267910	11/28/2006	TX	30.0	30		F	11/28/2006	Red nickel to quarter size welts on face, neck, arms and legs approx 12-16 hours after receiving the vaccine.				Y					U	11/27/2006	11/28/2006	1		UNK	UNK						1						1	Erythema; Urticaria	FLU3~SANOFI PASTEUR~U2254AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267911	11/28/2006	IL	72.0	72		M	11/28/2006	encephalopathy/encephalitis.  12/12/2006: Hospital MR received for admission from 11/05-28/2006 for c/o of nausea and dizziness which rapidly progressed to an organic encephalopathy. HPI: 75 yr old presented to the ER with nausea, vomiting, and dizziness.   PE revealed no localized finding however daughter stated he is not making sense (speaks Korean).   Admitted due to worsening mental status and agitation.  Seen by multiple consultants.  Pt. had occasional seizures during hospitalization. PEG tube inserted on 11/17/06 for feedings. Transfered to another hospital on 11/28/2006 for 2nd opinion. Impression is generally of an encephalitis (infectious vs other-vasculitis) vs CVA vs. meningitis. One consult mentions the possibility of an influenza related reaction. Awaiting Discharge summary for final DX. 02/05/2007 D/C Summary received.  As above with the following discharge DXs: 1) encephalitis  2) acute renal failure 3) dehydration  4) seizure disorder  5) pneumonia  6) diabetes mellitus  7) hypertension  8)  hypercholesterolemia. 02/26/2007 MR received for an additional 44 day hospital stay for condition as above.  Multiple consults included. Little improvement overall, however some improvement noted after 10 doses of IV Solumedrol.  Mental status continued to wax and wane.  Pt was discharged to a skilled nursing facility. Final DX:  Possible Hashimoto Encephalitis.					Y	23			Y	10/30/2006	11/05/2006	6	Labs upon ER admit unremarkable. CXR shows probable right lower lobe pneumonia. LABS and Diagnostics: WBC's WNL until Day 15 of hospital stay where it increased to 10.4-21.8. UCs-no growth, CSF- protein 123. glucose 87,WBC 62,culture:no growth, stool + for c.diff. on day 20 of hospital stay. Blood cultures- no growth, multiple microbiological tests for bacterial, viral, and fungal sources all negative. UAs largely WNL, Glucose levels mid 100s to 200s, electrolytes show low Ca and occ. high Na, BUN and Creat high, GFR dropped to 15 on day 5 of hospital stay then rose to normal by day 13. EEG WNL on 11/08/2006 became abnormal with generalized slowing on 11/15/2006. Multiple CTs and MRIs of brain initially showed no acute intracranial process, but later  mild generalized cortical atrophy and minimal peri-ventricular white matter ischemic demyelination was seen.  Findings suggest chronic linear right frontal cortical CVA.  No evidence of hemorrhage.  Nuclear Med. lung scan-normal. Additional pertinent Labs and Diagnostics:  Antithyroglobin antibodies 11/30/2006 slightly elevated.  EEG 12/04/2006- Abnormal due to moderate diffuse slowing, predominantly over the bifrontal areas.  These findings are c/w bilateral focal pathology.  This was not seen in previous ambulatory EEG on 12/01/2006.  No epileptiform activity seen	UNK	UNK	Meds: insulin, glyburide, topical nitroglycerine, tylenol PRN, albuterol PRN, Atrovent PRN, Ativan, PRN, Lopressor PRN, Hydralazine, and KCl.	none	kna PMH: Diabetes, Hypertension. NKDA.			1						1	Encephalitis; Encephalopathy	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0267913	11/28/2006	KY	91.0	91		F	11/28/2006	NONE	Y	11/27/2006							U	11/13/2006	11/27/2006	14		PUB	PUB	UNK					1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2258AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0267914	11/28/2006	FL	30.0	29		F	11/28/2006	Pt received flu vax 11/14/06, Frontal HA began 11/16-11/17, had right eye visual field cut CX 11/21/06, MRI 11/22 and Neuro exam DX with MS.  12/15/2006 Hospital MR received revealing a 29 yr old presenting to the ER from the opthomologist office with c/o right-sided blurred vision which began 1 week after her flu vax.  She had noted frontal headaches x 4 days beginning 2-3 days s/p vax. HPI: Pt. went to see eye MD on day of admission due to blurred vision and  partial loss of visual field.  She underwent visual field testing which showed a right inferior temporal field cut in the right eye.  She was refered to the ER where she was admitted for further testing. Impression: Almost certainly multiple sclerosis with first relapse.   02/16/2007 Office notes received from PCP. No new pertinent information./pc 03/02/2007 MR received from neurology consult.  3 F/U visits for MS dxd in hospital from 11/22/2006.  Impression: Relapsing remitting multiple sclerosis-stable.				Y	Y	1				11/14/2006	11/21/2006	7	Neurologist LP, MRI, Aphth exam DX MS.  Labs and Diagnostics: CBC, BMP unremarkable, sed rate 31, ANA (-), CSF (+) for RBCs and oligoclonal bands. CSF cultures (-).  CT of brain unremarkable.  MRI of brain with findings strongly suspicious for demyelinating disease such as multiple sclerosis. There is asymmetric circumferential increased signal involving the right optic nerve which could represent optic neuritis.  Other possible etiology would be acute disseminated encephalomyelitis.  Vasculitis is also possible but considered less likely given the asymmetric appearence of the right optic nerve.  Cerebellar tonsilar ectopia.	PVT	UNK	Prenatal Vitamin, Zoloft.  Meds: Zoloft, Aciphex.		PMH: Healthy with mild depression, 7 weeks post-partum. Allergies:  NKDA.			1						1	Headache; Multiple sclerosis; Visual field defect	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71356~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0267916	11/28/2006	VA	14.0	14		F	11/14/2006	Generalized rash 4 days after injection of flu vaccine.									N	11/07/2006	11/11/2006	4	NONE	PVT	UNK	NONE	NONE	Augmentin allergy			1						1	Rash	FLU3~SANOFI PASTEUR~U2164AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267917	11/28/2006	AR	8.0	8		F	11/27/2006	During mass flu clinic, child was given LAIV FLUMIST instead of inactivated influenza injection as requested by mom. Child developed nasal ulcers with nose bleeds requiring MD visit, antibiotics for 2 weeks.									Y	11/01/2006				OTH	OTH			Mother gives history of asthma.			1						1	Epistaxis; Medication error; Mucosal inflammation	FLUN3~MEDIMMUNE VACCINES, INC.~5004390~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0267918	11/28/2006	CA	1.59	1	.6	F	11/28/2006	Child developed generalized seizure 1 time ten days after immunization - DTaP, IPV, MMR, HIB, and Flu.				Y					Y	11/13/2006	11/22/2006	9		PVT	PUB		NONE	NONE			1						1	Convulsion	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B035AA~4~~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2191JA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE009AB~4~~RL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~Y1032~4~~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0215J~1~~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0267919	11/28/2006	CA	57.0	57		F	11/28/2006	11/17/06: Flu shot administered, within 5 minutes a metallic taste occurred - felt like coated mouth - lasted for 4 days. 11/18/06 - 11/20/06 Felt freezing cold then hot (no temp taken). 11/20/06 felt achy, sore throat. 11/21/06 Tingling in tongue. 11/22/06 Left sided facial paralysis, puffiness under left eye; neck/face left side painful (pain level 5-8) to touch and general pain. Left eye slight blurry (feels like a coating on eye); left side of tongue has sores on it. 11/28/06 Left arm (shoulder to elbow) has pain.  12/12/06 Received medical records from ER which reveal patient seen 11/22/06, 5 days s/p flu vax with an obvious left facial droop which included forehead involvement w/paralysis.  Left face numb & neck was painful.  Tx only with eye drops, eye ointment & taping of eye.   Final Dx: Left Bells Palsy.				Y					N	11/17/2006	11/17/2006	0	None; went to ER11/20/06. Diagnosed with Bell's Palsy. Patient has used hot/cold packs, liquid eye drops, eye ointment; taking aspirin; no diagnosis of stroke.	PUB	OTH	Synthroid; Talwin	NONE	Allergies to sulfa drugs, Ambien, form tape; 1988 Hep C diagnosis. PMH: hypothyroidism ALLERGIES: PCN, bactrim/sulfa	Very swollen arm~Influenza (Seasonal) (no brand name)~1~50.00~Patient		1						1	Dysgeusia; Facial palsy; Feeling cold; Hot flush; Pain; Paraesthesia; Paralysis; Tongue ulceration; Vision blurred	FLU3~SANOFI PASTEUR~U2251AA~6~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267920	11/28/2006	WA	2.0	2	.7	F	11/23/2006	Patient given 0.25 ml of Fluvirin instead of Fluzone.									Y	11/20/2006			NONE	PUB	UNK		NONE	NONE			1						1	Medication error	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70740~1~~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267921	11/28/2006	WA	0.81	0	.8	F	11/23/2006	Patient given 0.25 ml of Fluvirin instead of Fluzone.									Y	11/20/2006			NONE	PUB	UNK		NONE	Eczema			1						1	Medication error	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70740~1~~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267922	11/28/2006	IL	10.0	10		F	11/21/2006	Child was given flu vaccine in office. Upon leaving her appointment, she fainted in the reception area hallway.									Y	11/21/2006	11/21/2006	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Syncope	FLU3~SANOFI PASTEUR~U2196AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267912	11/29/2006	TX	47.0	47		M	11/29/2006	Within 24 hours, I began to have headaches and feel excessively sleepy, requiring up to 18 hours of sleep a day. Symptoms peaked at 5 days after the vaccine administration. Did not leave bed that day. Also mild photophobia. No fever. No URI or other symptoms of infection. Husband and son who got vaccines were well with no other illness and no side effects except local soreness around injection site. The excessive sleepiness and headache gradually resolved by the seventh day after the vaccination.  I get influenza vaccine every year, I have never had a reaction like that.									Y	11/09/2006	11/10/2006	1	none	UNK	UNK	topamax, corgard, trazadone, effexor, melatonin, benadryl, ventolin prn	none	CT contrast, amantadine allergy  migraine headade, asthma, allergic rhinitis, obstructive sleep apnea			1						1	Headache; Injection site pain; Photophobia; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0267915	11/29/2006	CA	62.0	62		M	11/28/2006	Patient blood pressure elevated for about 3 days. Diastolic usually 80 went up to 110 at one point. After 3 days, BP returned to normal.									Y	11/17/2006	11/18/2006	1	NONE	OTH	PVT	Felodipine		NKA			1						1	Blood pressure increased	FLU3~SANOFI PASTEUR~U2218AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267925	11/29/2006	CO	41.0	41		F	11/28/2006	Patient is complaining of numbness in the arm where the shot was given. She also says the shot was unusual feeling and painful when given.									N	10/06/2006	10/06/2006	0		OTH	PVT						1						1	Hypoaesthesia; Pain	FLU3~SANOFI PASTEUR~U2240AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267938	11/29/2006	CA				U	11/29/2006	This case was reported by a pharmacist and described the occurrence of possible aseptic meningitis in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of influenza vaccine. At an unspecified time after vaccination with influenza vaccine, the subject experienced possible aseptic meningitis and was hospitalized. At the time of reporting, the outcome of the event was unspecified.					Y	0			U					OTH	OTH					A0628884A	1						1	Meningitis aseptic	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0267942	11/29/2006	MN	61.0	61		M	11/29/2006	11/17/2006 started with numbness in both feet L>R by 11/30/06 progressed to both arms. C/o extreme pain between shoulders. Transferred to Hospital neurology. Received 3 treatments of IgG. 12/15/06 Received medical records from hospital which reveal patient had been admitted for 1 day & transferred from outlying hospital on 11/24/06 w/severe back pain for approx 1 week with weakness of all extremities.  Received flu shot 11/1/06.  Neuro exam in ER revealed absent reflexes bilaterally at ankles, knees, biceps, triceps & brachioradialis tendons.  EMG testing done in ER strongly suggestive of GBS.  Treated w/steroids & IVIG.  Improved slowly & was to receive inpatient rehab.  Prognosis was felt to be quite good.  HTN diagnosed with this admission. Final Dx: Guillain Barre Syndrome. 12/18/06 Received D/C summary from hospital.  Pt admitted 11/24/06 & d/c to home on 12/5/06, ambulatory but still weak with improved forced vital capacity  (from 2.2L to 3.9L) Information received from the annual follow up indicates recipient has not recovered. Still lacks some upper body strength, has difficulty with his balance when tired, some fine motor difficulties in his hands and numbness and tingling in his feet. He is back to his full time work. 3/31/10 Follow up: He is still experiencing pain in his back. (Uses Duragesic Patch). He has numbness in his fingers and feet. He descrubes it as walking on pins. Has been unable to return to his work.					Y				N	11/03/2006	11/17/2006	14	LABS: MRI done 11/21 of complete spine neg except for DJD.  EKG showed BBB & bradycardia.  Elevated liver enzymes.	PUB	PVT	NONE		PMH: nephrolithiasis, colon polyps, shoulder surgeries x 2, traumatic amputation of 2 fingers.			1						1	Areflexia; Asthenia; Back pain; Balance disorder; Bradycardia; Bundle branch block; Electrocardiogram abnormal; Electromyogram; Guillain-Barre syndrome; Hepatic enzyme increased; Hypertension; Hypoaesthesia; Immunoglobulin therapy; Impaired work ability; Motor dysfunction; Muscular weakness; Musculoskeletal pain; Neurological examination; Nuclear magnetic resonance imaging; Osteoarthritis; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70278~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0267945	11/29/2006	ME	0.94	0	.9	M	11/29/2006	See attached office note, hospital notes.				Y						11/16/2006	11/16/2006	0	See attached notes	PVT	PUB		Cough, fever x 1 day, viral, fussiness, poor eating, and sleeping, highest temp 103.	See 11 days earlier in ER DX viral illness.			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~UT2191KA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267946	11/29/2006	VA	70.0	70		F	11/28/2006	Redness, swelling, aching, arm felt hot, the next morning after injection at injection site.									Y	11/14/2006	11/15/2006	1		PVT	PVT		Sinusitis, asthmatic bronchitis.				1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72007~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0089F~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267949	11/29/2006	CA	4.0	4		M	11/22/2006	Mom stated that around 3:00pm on Tues afternoon she noticed that his left thigh was swollen size of baseball warm to touch, mom called nurse for advice at night they told her stay of legs and cold compress mom did, Wed am he woke up swelling decreased but still red to area and warm, leg is same size as other, no raise noted on left thigh, right thigh looked good, no adverse reactions noted, child doing good, playing well, happy, says leg is hot/burning. Mom will C/B if any other SX appear.									U	11/20/2006	11/21/2006	1		PVT	PVT						1						1	Injection site erythema; Injection site oedema; Injection site warmth; Skin burning sensation	DTAP~SANOFI PASTEUR~U1965AB~UNK~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2168DA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1031~4~SC~RL~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~1139R~2~SC~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0267950	11/29/2006	CA	61.0	60		F	11/21/2006	I got the Flu shot and Pneumonia shot in the same muscle in left arm, upper arm became red, hot, swollen, and itchy and painful. I could not lift anything or raise arm or sleep on left side for 3 days. After the 2 shots, I told a nurse friend of mine, who said one should not get the 2 shots in the same muscle in the same arm at the same time. I could not go dancing Fri and Sat night like I usually do because of pain when I move my left arm.									Y	11/09/2006	11/09/2006	0		PUB	PUB	Paxil Anti depressant, Trazodone.	NONE	None this year, I had polymyalgia.			1						1	Hypokinesia; Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U2251AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0620F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267951	11/29/2006	GA	64.0	64		F	11/21/2006	Swollen, hard, red, hot right upper arm at site of injection, felt weak day after.									Y	11/07/2006	11/07/2006	0	NONE	PVT	PVT	Diazepam	NONE	Sulfa			1						1	Asthenia; Injection site erythema; Injection site induration; Injection site oedema; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71211~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0352F~1~~RA~PNEUMO (PNEUMOVAX)~1|TD~MASS. PUB HLTH BIOL LAB~TD159~UNK~~LA~TD ADSORBED (TDVAX)~1	USA		Influenza
0267952	11/29/2006	PA	5.0	5		U	11/17/2006	Local swelling and enlarging erythema of 4-5 cm.										11/15/2006				PVT	UNK						1						1	Injection site erythema; Injection site oedema	DTAP~SANOFI PASTEUR~C2489AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2280A~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1054P~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0267953	11/29/2006	VA	65.0	64		M	11/24/2006	Pt had a 2 1/2 - 4 inch redness to right arm where pneumovax was given. Pt reports was running a fever on the 7th. Pt reports on 2/8/06 right arm is slightly swollen, warm and sore to the touch. Told pt per DR to take Motrin as directed on bottle and to use ice, on and off for 15 minute intervals for a localized reaction.									Y	02/06/2006	02/07/2006	1		PVT	PUB	Multivitamin	NONE	Allergies sulfa, cataracts, H/O pneumonia, H/O prostatitis.			1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U1825FA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1005P~1~SC~RA~PNEUMO (PNEUMOVAX)~1|TD~AVENTIS PASTEUR~U1596CA~UNK~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0267954	11/29/2006	PA	0.93	0	.9	M	11/21/2006	Day of vaccine fever to 104.6, brief 30 sec seizure. No treatment for this. DX febrile seizure.				Y					Y	11/20/2006	11/20/2006	0		PVT	PUB		NONE	NONE			1						1	Febrile convulsion	FLU3~SANOFI PASTEUR~U2286AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267955	11/29/2006	WA	81.0	80		F	11/22/2006	Severe Diarrhea, nausea, weakness, chills.				Y					Y	11/15/2006	11/15/2006	0		PVT	PVT		NONE		~Td Adsorbed (no brand name)~~0.00~In Patient		1						1	Asthenia; Chills; Diarrhoea; Nausea	FLU3~SANOFI PASTEUR~U2255AA~6~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267956	11/29/2006	WA	85.0	84		F	11/22/2006	Diarrhea									Y	11/16/2006	11/16/2006	0		PVT	PVT		NONE	Ampicillin, Sulfa, Keflex.			1						1	Diarrhoea	FLU3~SANOFI PASTEUR~U2261AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267960	11/29/2006	TX	45.0	45		F	11/21/2006	Approx 5 minutes after receiving Tdap and Flu shot. Pt walked out of exam room, then reported not feeling well. Sat down in waiting room, became minimally responsive, slowly answering question. Hypotensive, EMS Called taken to hospital and later discharged home. Pt described feeling of burning 5 minutes after injection throughout entire body.				Y					Y	11/17/2006	11/17/2006	0		PVT	PVT	NONE	NONE	NONE			1						1	Coma; Hypotension; Malaise; Skin burning sensation	FLU3~SANOFI PASTEUR~U2239AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2609AA~1~~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0267961	11/29/2006	MO	55.0	55		F	11/20/2006	Bruning and neck pain x 2 days after shot, then back/spine pain, moving over to both hip joints and Pelvic area. Created severe pain requiring use of Ibuprofen for pain, and using a walker to relieve pressure on weight bearing joints.				Y					U	10/31/2006	10/31/2006	0	Chest X ray, bone scan on 11/16/06, CBC, CMP	PUB	UNK	Ibuprofen, Effexor	NONE	Breast Cancer 1994			1						1	Arthralgia; Back pain; Hypokinesia; Neck pain; Pelvic pain; Skin burning sensation	FLU3~SANOFI PASTEUR~~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267962	11/29/2006	MT	5.0			M	11/20/2006	Lt arm vaccination site red immediately. Left arm swelling in approx 1 hr gave Benadryl. Contacted Physician RX for Augmentin, No S/S of swelling or redness as of 11/20/2006.									Y	11/17/2006	11/17/2006	0		OTH	PUB		NONE	NONE			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U2255AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267963	11/29/2006	TX	43.0	42		F	11/17/2006	Developed burning hands about 1:00 the next morning after flu shot day before. Got hives/itching to trunk, elbows, butt, back of legs. Took Benadryl and Cimetimine with resolution of symptoms. Symptoms recurred later in day, and 2100 that even. Meds repeated with resolutions of symptoms.									Y	11/09/2006	11/10/2006	1		UNK	UNK						1						1	Pruritus; Skin burning sensation; Urticaria	FLU3~SANOFI PASTEUR~U2279AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267964	11/29/2006	CO	45.0	45		M	11/21/2006	Patient noticed soreness, difficulty of movement (raising arm above shoulder) approximately 1 week after flu shot.									U	10/15/2006	10/19/2006	4	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U2240AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267965	11/29/2006	CO	6.0	6		M	11/24/2006	On 11/15/06, patient developed rash consistent with erythema multiforme. Has been treated with Benadryl, Zyrtec and Atarax.				Y					N	11/10/2006	11/15/2006	5	Negative strep culture.	PVT	PVT	On date of rash onset, patient finished 10 day course of Cephalexin.	Strep pharyngitis	Amoxicillin; Biaxin			1						1	Erythema multiforme; Rash	FLU3~SANOFI PASTEUR~U2255AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267966	11/29/2006	TX	14.0	14		F	11/21/2006	Mother states patient developed hives and whelps at approximately 1930 on 11/20/2006. Denies difficulty breathing or any respiratory distress.									Y	11/20/2006	11/20/2006	0		PVT	PUB		NONE	Asthma; Allergic rhinitis; Overactive bladder; Antiphospholipid syndrome; Sjogren's syndrome.			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2250AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1921AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0267967	11/29/2006	CA	4.0	4		F	11/20/2006	Left arm (deltoid region) swelling, redness, warmth 8cm area. Tender to touch.				Y					Y	11/17/2006	11/19/2006	2		PVT	UNK						1						1	Erythema; Feeling hot; Swelling; Tenderness	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B018AA~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~Y1049~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB099CB~1~IM~LA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~Y1049~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0267979	11/29/2006	MD	68.0	68		F	11/29/2006	Received the flu vaccine on 11/12/06. About a week after she began to have crampy type sensation in her lower chest and epigastrium. SOB, Temp 100.5.  1/9/07 Received medical records from hospital which reveal patient admitted 11/28-11/30/06 with chest pain which increased with lying down & breathing, dyspnea, night sweats & fever/chills for approx 1 wk.  She was d/c to home on steroids & was to f/u with cardiologist & rheumatologist as well as have a repeat CT of chest in 1 mo.  FINAL DX: Pleural pericarditis, probably viral, with left effusion, question of mediastinal adenopathy; HTN; depression; & Grave's disease, thyroidectomy & parathyroidectomy./ss					Y	2				11/12/2006	11/20/2006	8	CT of the chest shows effusions on both sides. LABS: CXR revealed left effusion. CT of chest revealed left effusion with atelectasis & a 6 mm pericardial effusion & question of mediastinal adenopathy. ECHO showed small effusion w/o tamponade. Sed rate elevated at 106. Cultures from thoracentesis were neg.  ANA had titer greater than 1-320 with mixed patter, speckled & nucleolar.  RA was neg. WBC 15.2	UNK	UNK	Synthroid 0.125mg daily Lexapro 10mg daily Zyrtec 10mg daily Benicar 20mg daily Prilosec OTC	None	Dx as a child with Rheumatic Fever. Hx of Hypertension Allergies: ASA, ibuprofen PMH: possible rheumatic fever in childhood & receives prophylaxis for endocarditis prior to dental work. DJD, dry macular degeneration. History of heart failure.			1						1	Dyspnoea; Muscle spasms; Pleural effusion; Pyrexia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0267980	11/29/2006	NY	63.0	63		F	11/29/2006	Large (15 cm) local reaction in area of Pneumovax administration on lower outer upper arm.  No fevers/lymphagiitis/other skin changes.  Smaller red area in location of flu shot given higher up on arm in same arm.				Y					U	11/27/2006	11/29/2006	2		UNK	UNK	Prednisone, fosamax, methotrexate	shoulder pain (left)	amoxicillin allergy rheumatoid arthritis			1						1	Injection site erythema; Injection site reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71926~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0604R~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0267981	11/29/2006	PA	44.0	60		M	11/29/2006	Increased Temperature, severe generalized muscle pain. 2 days later developed sore throat and bilateral lymph adenopathy (neck).									Y	11/07/2006	11/23/2006	16	NONE	UNK	UNK	CLARITEN,SINGULAIR	NONE	ALLERGIC TO DUST	Temp, muscle pain~Hep B (Engerix-B)~2~0.00~In Patient		1						1	Body temperature increased; Lymphadenopathy; Myalgia; Pharyngolaryngeal pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA234AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0267982	11/29/2006	AL	54.0	54		F	11/29/2006	Administer .5ml Fluzone IM Left deltoid. After 15 minutes pt expressed that she was having some itching above the injection site on left arm. Upon observation the upper portion of her arm at the junction of the shoulder was erythematous as well at the inner aspect of the upper arm. The site was not warm to touch and there was noted central clearing with redness only at the inner and upper portion of arm. Pt complained of slight pain.  She stated that she had many allergies and had PO benadryl in purse. She took two 25mg Benadryl by mouth. denies any difficulty breathing or other complaints. Pt observed for 15 additional minutes without incident. redness, pain and itching decreased. Pt released with instruction to seek medical attention if symptoms worsened. PT left Alert and oriented x3.									Y	11/28/2006	11/28/2006	0		MIL	MIL	Atenolol, 50mg oral TD; Lorazepam 1mg oral TBD; Fluticasone Propionate 0.05%, spray, nasal, INH 2 sprays in each nostril QD; Phenobarbital 30 mg, oral 2 tabs PO BID, Montelukast sodium, 10mg, tab, TD; Abuterol 90mcg, aerosol powder, Inhalat	Felling well no complaint of illness	Allergies; Monopril (fosinopril sodium)			1						1	Erythema; Injection site reaction; Pain; Pruritus	FLU3~SANOFI PASTEUR~U2259AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0267985	11/29/2006	SC	48.0	48		F	11/29/2006	Fever 101 degrees Friday night (11-17-06) and Saturday.  Severe pain left arm X4 days.  Redness at site.  Went to PMD today and is on antibiotic x 7 days.									Y	11/16/2006	11/17/2006	1		UNK	UNK	NONE	NONE	No Known Allergies		SC0624	1						1	Injection site erythema; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~72000~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0601F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0267986	11/29/2006	NV	56.0	56		F	11/29/2006	CONGESTION,FEVER,CHILLS,MUSCLE WEAKNESS & TIGHTNESS & PAIN, DIZZINESS									Y	11/27/2006	11/27/2006	0		UNK	UNK	ACTONEL, MENOSTAR	NONE	NONE	FLU SYMPTOMS~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Chills; Dizziness; Muscular weakness; Nasal congestion; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0267987	11/29/2006	PA	64.0	64		F	11/29/2006	Patient called our office on 11/28/2006 stating she developed pain in her injection site arm (right arm) on day of injection, 11/17/06. Pain was gone in am of 11/18/06. Pain again occurred on 11/20/06 and was still present at the time of the call. Patient did not experience unusual pain at the time of the injection.I spoke with the county health department and they suggested she see her family doctor. Patient is willing to do this. She will call her PCP today.									U	11/17/2006	11/20/2006	3		UNK	UNK						1						1	Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA231BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0267989	11/29/2006	MA	41.0	41		F	11/29/2006	CAUSED WHEEZING, HOARSNESS AND CHEST PAINS.  WHEEZING STARTED APPROX. 2-3 HOURS AFTER INJECTION ON 11/25/06 AND GOT PROGRESSIVELY WORSE AND I COULD NO LONGER CONTROL IT WITH MY ALBUTEROL RESCUE INHALER RESULTING IN A DOCTORS VISIT FOR A NEBULIZER TREATMENT  ON 11/27 AND BEING PUT ON 60 MGS. OF PREDNISONE WITH A 12 DAY TAPER AND A 3 DAY FOLLOW UP VISIT ON 11/30/06.				Y					U	11/25/2006	11/25/2006	0		UNK	UNK			NKA TO FOOD OR DRUGS ALLERGIC TO DUST, TREES, MOLD, DOGS, ETC. ASTHMATIC (REASON FOR VACCINATION)			1						1	Chest pain; Dysphonia; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0267992	11/29/2006	MA	1.3	1	.3	F	11/29/2006	PT BEGAN WITH TEMP 104.7 ON 11/25/06. ON 11/26/06 PT HAD TEMP 102.7 AND RED WARM RASH ON BOTH THIGHS. ON 11/27/06 WOKE WITH BOTH CHEEKS BRIGHT RED AND WARM TO THE TOUCH. ON 11/28/06 NO FEVER, APPROX 35 RED LESIONS ON BELLY AND BACK. SEEN IN OFFICE 11/28/06 BLANCHING RASH, SLIGHTLY RAISED HEAD TO TOE SMALL SLIGHTLY PINK SKIN PATCH RIGHT POSTERIOR UPPER THIGH. NO TREATMENT PRESCRIBED.									Y	11/17/2006	11/25/2006	8		UNK	UNK	NONE	NONE	NONE			1						1	Erythema; Feeling hot; Pyrexia; Rash	FLU3~SANOFI PASTEUR~UT2191JA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1032~3~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0615F~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0267993	11/29/2006	VA	49.0	49		F	11/29/2006	After receiving a flu shot the arm has had increasing pain at the top of the shoulder. Pain interferes with ADL and sleep. Despite treatment with 800mg TID of Ibuprofen the pain is unrelieved. ROM is decreased but there is no visible swelling or redness. Client had lab work to rule out infection.				Y						11/03/2006	11/03/2006	0	A CBC- reported as negative	UNK	UNK	Synthroid,Femera,Ibuprofen		Hypothryoid, Hx breast Ca			1						1	Infection; Insomnia; Joint range of motion decreased; Shoulder pain	FLU3~SANOFI PASTEUR~U2256AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0267998	11/29/2006	MT	1.02	1	.0	F	11/28/2006	Day 1-4, red, swollen, painful, warm to touch left thigh. Fever first 3 days. Days 4-8, decreased redness and warmth and pain. Hard lump 1 inch x 1/2 inch remains in area of injection. Patient is improving.									N	11/20/2006	11/21/2006	1		PUB	PUB	NONE	NONE	Had haemophilus influenza, hospitalized at age 4 months with bacterial meningitis.			1						1	Feeling hot; Injection site erythema; Injection site mass; Injection site swelling; Pyrexia	FLU3~SANOFI PASTEUR~U2191BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0931F~1~IM~RL~HEP A (VAQTA)~1|HIBV~MERCK & CO. INC.~0005F~3~IM~LL~HIB (PEDVAXHIB)~1|MMRV~MERCK & CO. INC.~0975F~1~SC~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~8675E~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0267999	11/29/2006	MT	51.0	51		F	11/21/2006	Redness, hives, Left arm and Avilla, nausea, headache 2-3 days, malaise. Seen 11/20/06 at clinic  and patient is taking Zyrtec 10mg every ten hours. Symptoms: Resolving.									Y	11/18/2006	11/18/2006	0	None	PUB	OTH		None				1						1	Erythema; Headache; Malaise; Nausea; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0485F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268000	11/29/2006	NH	36.0	35		F		Pain, tenderness to site of injection that radiates to neck and down arm.				Y					U	11/29/2006	11/29/2006	0		PVT	OTH		None	None			1						1	Injection site pain; Tenderness	FLU3~SANOFI PASTEUR~U2255AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268001	11/29/2006	CO	57.0	57		F	11/27/2006	Three hours after injection, cough, tightness in chest. Administered Abuterol inhaler 2 puffs and resolved also Benadryl 25mg.									Y	10/20/2006	10/21/2006	1	None	PUB	PUB		None	Exercise induced asthma			1						1	Chest discomfort; Cough	FLU3~SANOFI PASTEUR~U2240AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268002	11/29/2006	MO	36.0	35		M	11/27/2006	Papular erythema rash. Left axilla, left elbow hands flushed.				Y					Y	11/15/2006	11/16/2006	1		PVT	OTH	None	None	Seasonal Allergy Rhinitis			1						1	Flushing; Rash papular	FLU3~SANOFI PASTEUR~U2245AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268003	11/29/2006	IL	44.0	43		F	11/29/2006	Employee reports pain and decreased mobility in R arm and shoulder. Pain is intermittent and increases when raising arm over head.									U	11/01/2006	11/01/2006	0	None at this time	PVT	PVT	None	None	None			1						1	Pain	FLU3~SANOFI PASTEUR~U2239AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268004	11/29/2006	IL	46.0	45		F	11/24/2006	Employee reports pain and decrease in mobility in Left arm and shoulder. Pain is intermittent and increases when raising arm over head. Pain is 8 on 0-10 scale. Takes Aleeve 4 tabs per day.				Y					U	11/01/2006	11/01/2006	0	None at this time	PVT	PVT	None	None	None			1						1	Hypokinesia; Pain	FLU3~SANOFI PASTEUR~U2239AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268006	11/29/2006	WA	1.38	1	.4	F	11/28/2006	Vesicle like rash Left thigh where administered. Left abdomen, Left arm, a few areas on Right thigh.									Y	11/17/2006	11/18/2006	1	None	PVT	PUB	None	None	None			1						1	Rash vesicular	FLU3~SANOFI PASTEUR~U2219AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1031~3~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0092F~1~IM~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|VARCEL~MERCK & CO. INC.~0245F~1~IM~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0268019	11/30/2006	GA	45.0	45		F	11/24/2006	Skin colored lump at side immediately two hours later lymph node swelling on let side of neck.  Next pm. both sides of neck swelling, site itching at site, hives next day, saw medical doctor 2 days later.  Not feeling well.  Took BENADRYL-took script for AVELOX, PREDNISONE.				Y					Y	10/19/2006	10/19/2006	0	NONE	PVT	OTH	NONE	mild sore throat	AUGMENTIN, DEMERSOL, FLAGYL, ASA			1						1	Lymphadenopathy; Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71353~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0268020	11/30/2006	WI	28.0	28		F	11/21/2006	Puffy and swelling fingers and tongue.  Reported puffiness of hands/fingers and swelling tongue.  Complain of mild tightness in throat.  BENADRYL 25 mg given times 2, 1 hour apart.  Returned to work.									Y	11/21/2006	11/21/2006	0	NONE	OTH	PVT		NONE	sulfa allergy			1						1	Oedema peripheral; Swelling; Throat tightness	FLU3~SANOFI PASTEUR~U2258AA~3~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268022	11/30/2006	MN	5.0	5		F	11/21/2006	Flumist given at 10:30 am (1 spray each nostril).  Patient mother returned with a bloody nose. 1/2 to 1 cup blood overall.  Bloody nose began 15-20 minutes after.									Y	11/21/2006	11/21/2006	0		PUB	PUB		Cold/URI symptoms	NONE			1						1	Epistaxis	FLUN3~MEDIMMUNE VACCINES, INC.~500434P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0268023	11/30/2006	MS	42.0	42		F	11/20/2006	Flu vaccine received 11-16-06 at 11am.  11-17-06 woke up, eyes swollen, rash on throat. Saw ER physician 11-17-06 at 10 pm noted to have ?abscess above right eye, employee stated she had hit her head on cabinet at home in that spot 2 weeks before.				Y						11/16/2006	11/17/2006	1		UNK	UNK		NONE	Latex, asthma			1						1	Eye swelling; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71639~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0268024	11/30/2006	MN	45.0	45		F	11/22/2006	Patient started feeling neck pain Wednesday morning that moved into her legs and arms.  She said her entire body felt like it had a Charlie horse by afternoon late.  She said the muscle pain was so bad that night.  She spent 2 hours in the bathroom because she could not get off the stool because of the . She said she had the worst headache of her life and it felt like her chest was on fire.  Patient was seen at the clinic for her symptoms and given an injection of steroids.  Not sure what day patient was seen at the clinic. She called on 11/20/06 to let us known she had been seen and was doing better.				Y					Y	11/14/2006	11/15/2006	1		PVT	UNK		NONE	Allergies: CODEINE, CYCLOBENAPRINE, HCTZ, SUMATRIPTAN, PROCHLORPERAZINE, FUROSEMIDE			1						1	Headache; Myalgia; Neck pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA237BA~3~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0268025	11/30/2006	GA	43.0	43		F	11/22/2006	Itching, Reddened skin, shortness of breath, swelling eyes, lips, fingers, within 15 minutes of receiving shot took PO BENADRYL.  Then saw medical doctor-given KENALOG IM and MEDROL dose pack.				Y					Y	11/16/2006	11/16/2006	0	NONE performed	PVT	OTH	NONE	NONE	bee sting			1						1	Dyspnoea; Erythema; Eye swelling; Oedema peripheral; Pruritus; Swelling face	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72001~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0268026	11/30/2006	MA	59.0	59		F		2 days after Flu vaccine, headache, body aches, stuffy nose, lasted 2 days- turned into head cold with lots of yellow mucus.									Y	11/17/2006	11/19/2006	2		PVT	UNK	PROZAC, ASMACORT LESCOL	NONE	CODEINE allergy, asthmatic, osteoarthritis			1						1	Headache; Nasal congestion; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0268030	11/30/2006	FL	20.0	20		M	11/30/2006	Bell's palsy  12/8/06 Received records from provider which reveal patient experienced right facial weakness approx 24 hours s/p flu vax.  Weak right eye closure & smile was asymmetrical.  Treated w/anti viral & steroids.  Clinic visit of 11/20 revealed facial weakness unchanged but able to close right eye.  Treatment continued. Final Dx: Right Bells Palsy.									N	11/13/2006	11/14/2006	1		UNK	UNK	Singulair 10 mg qd Albuterol inhaler prn	None	Mild asthma PMH: asthma, allergic rhinitis			1						1	Facial palsy; Ophthalmoplegia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71215~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268031	11/30/2006	PA	0.0			F	11/27/2006	Approximately 1 minute after receiving influenza vaccine, the patient states she lost her vision and hearing and felt dizzy.  She sat on the floor, was pale, tachypneic and bradycardic.  Patient gradually felt better and refused treatment after EMS was called.									Y	11/21/2006	11/21/2006	0		UNK	UNK						1						1	Blindness; Bradycardia; Dizziness; Impaired healing; Pallor; Tachypnoea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268034	11/30/2006	TX	30.0	30		F	11/30/2006	Received flu vaccine on 11/29.  Ten minutes later she experienced a seizure.  Later that evening she experience another seizure.  She does have a one year history of seizure disorder, treated with Trileptal and Neurontin.									Y	11/29/2006	11/29/2006	0	None	UNK	UNK	Trileptal 900 mg twice a day Neurontin 300 mg three times a day	None	Seizure disorder (onset ~12 months ago) Last seizure before this event was on 11/23/2006.			1						1	Condition aggravated; Convulsion	FLU3~SANOFI PASTEUR~U2212AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268035	11/30/2006	WY	88.0	88		M	11/30/2006	Approximately 4 inch reddened area, swollen, erythema, very sore, surrounding vaccination areas.   Stated that area became painful on during evening on day he received vaccination. He spoke with this nurse next day.									U	11/27/2006	11/27/2006	0		UNK	UNK		none	NKDA			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2281AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1174F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268037	11/30/2006	OK	29.0	29		F	11/30/2006	11-09-06 Developed sore throat and cough.  11-10-06 Began fever in p.m. and body aches 11-11-06 Increased body aches and high fever- temp not taken 11-12-06 Seen in Hosp ER for fever, body aches and cough.  After care instuction sheet from ER  Dx - Fever unknown Etiology RX Loritab 7.5/500 1-2 tab q 4-6 hrs for pain.  11-13-06 Reports to health department clinic that she is feeling better but cough continues.				Y					Y	11/09/2006	11/09/2006	0	11-12-06 Bloodwork done ER - client did not receive a report.	UNK	UNK	none	none known	NKA Denies birth defects or known medical conditions			1						1	Cough; Pain; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500440P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0268039	11/30/2006	TX	17.0	17		F	11/30/2006	Vaccinated on Monday. Nasal congestion 24 hrs post vaccination, then within 96 hrs (on Firday)had voice hoarsness that worsened to complete voice loss on Sunday with gradual return on Monday. 10 days post vaccination voice remains hoarse but improving. No fever, no sore throat, no throat reddness or pustules, no fatigue or change in appetite, no enlarged nodes. Did not have cough, just slight irritation in throat area.									Y	11/20/2006	11/24/2006	4	none	MIL	MIL	none	none	none			1						1	Dysphonia; Nasal congestion; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~500431P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0268040	11/30/2006	WY	20.0	20		F	11/30/2006	States that area where shot was given hurt from the time she got the shot. No time given as to symptoms beginning. Stated that area swelled up, about 1 inch area. Hot, kind of hard. She initially called PH to report her reaction late afternoon of 11/29/2006, two days after shot given.									Y	11/27/2006	11/27/2006	0		UNK	UNK		none	NKA			1						1	Injection site induration; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2281AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268041	11/30/2006	MO	8.0	8		M	11/07/2006	Child stated he felt pale fell sideways off chair with body stiff, with hands clenched began shaking and eyes rolled back.  White with blue around mouth.  Lasted one minute, no memory of event. PCP MR received which revealed OV for parental report of seizure activity several hours after flu shot.  MR received from hospital Neurology consult.  Review of systems negative with exception of 2 previous seizure episodes. Assessment:  Suspect complex partial seizure with secondary generalization, though cannot r/o syncopal convulsions.									Y	11/06/2006	11/06/2006	0	LABS and DIAGNOSTICS: EEG revealed no abnormalities at that time.  Normal wake and sleep EEG.  No epileptiform activity was seen in the recording.	UNK	UNK	none	none	PMH includes one previous seizure episode while having a splinter removed from his finger, maternal drug use during pregnancy.  ER record from 8/14/2005 with DX of vaso-vagal episode-transient.		MO200642	1						1	Convulsion; Cyanosis; Eye movement disorder; Loss of consciousness; Musculoskeletal stiffness; Pallor; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71826~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268042	11/30/2006	MO	38.0	38		F	11/08/2006	38 year old white female developed rapid onset of symptoms: redness with itching and feeling hot: hands, feet, neck, ears, lips slightly swollen with tingling.  Resoved with 1. 50 mg oral diphenhydramine 2. cool compresses 3. iced water symptoms relieved no sequele with approx 30-25 min. (2:25 p.m. to 3:15 p.m.)  Flu vaccine given 5 hours prior to symptoms.  VS 159/105 102 n difficulty breathing.									Y	11/03/2006	11/03/2006	0	none	UNK	UNK	prevacid, wellbutrin, nortriptyline	sinus infections at the end of antibiotic course and oral steroids 7 days	allergic: penicillin 1. abdominal migraines 2. obesity		MO200643	1						1	Erythema; Face oedema; Feeling hot; Paraesthesia; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71642~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268043	11/30/2006	IA	5.0	0	.0	M	11/30/2006	Developed red, raised rash to chest, abdomen, and upper arms within 40 minutes of immunization.									Y	11/29/2006	11/29/2006	0		UNK	UNK	none	none	nka			1						1	Rash erythematous	FLU3~SANOFI PASTEUR~U2262AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268044	11/30/2006	MO	23.0	23		M	11/08/2006	Patient had flu and pneumonia injections Monday.  Came to office yesterday (Wednesday) with an itchy rash on face and back.  Patient also stated he had chest pains and very sleep but these symptoms were better at visit.									U	11/06/2006	11/08/2006	2		UNK	UNK		none	allergies: RCN=skin rash, Bactrium DS=flairs ulcer, cortison=hyperactivity Medical conditions: bowel problems, HTN, Stroke, liver disease, stomach ulcer, ear problems, mental illness		MO200644	1						1	Chest pain; Rash pruritic; Somnolence	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69898~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0618F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268045	11/30/2006	MD	85.0	85		M	11/30/2006	Began having UR symptoms a month ago. c/o cough, stuffy nose, myalgia, malaise. 12/21/06 Received medical records from hospital which reveal patient admitted 11/25/-12/1/06. Had SOB for approx 1 week prior to admit which had started after the flu vax. Presented to ER w/CHF & acute renal failure.  Cardio & nephro consults done. Final Dx: CHF secondary to acute viral myocarditis; and BPH.					Y	6				10/23/2006	10/24/2006	1	CXR- Diffuse increase in interstitial markings consistent with CHF.  Radiographic cardiomegaly noted. CPK iso- elevated LABS: echocardiogram showed severely reduced LV function, aortic valve stenosis & sclerosis and mod mitral valve regurg.  EF was 25-35%. WBC 8.9.  Cardiac enzymes neg although troponin was 1.4	UNK	UNK	None identified.	None	Psoriasis x 7 years PMH: right groin hernia repair; dental extractions; psoriasis; and GERD.			1						1	Blood creatine phosphokinase increased; Cardiac failure congestive; Cough; Malaise; Myalgia; Myocarditis; Nasal congestion; Viral infection	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0268046	11/30/2006	MA	60.0	60		M	11/30/2006	red and swollen at site of injection. thought he might have a fever.									U	11/28/2006	11/28/2006	0	none	UNK	UNK	Omeprazole SA 20 mg	none	reflux			1						1	Injection site erythema; Injection site swelling; Pyrexia	FLU3~SANOFI PASTEUR~U2198AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577R~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268047	11/30/2006	GA	28.0	28		F	11/30/2006	Wheezing, cough, hives all over legs and upper torso (back and front).									Y	11/29/2006	11/29/2006	0	N/A	UNK	UNK	Proventil inhaler	none	dust mites, pollen, cat dander			1						1	Cough; Urticaria; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0268048	11/30/2006	MI	21.0	21		M	11/30/2006	Patient became dizzy and hot on the way home in the car.  Pulse 120/Respiration 6.  Called 911, EMT stated glucose 88, pulse 80 doing better.  At ER was given script for Benadryl. Per 60 day follow up: Approx. 50% of strength recovered in legs; hands? Still in physical therapy 3 x/week. Extreme pain in knees-R>L instantly with standing ->walking -> movement. Neg evalaution with rheumatologist. MRI March 17, 07 pending appoint with orthopedic, MD. Continues to be on Medical leave from job. On egg free diet due to allergic rex to eggs in hospital, carries EPI-PEN. On daily medication for pain and stomach (ZANTAC) prevention. Multiple MD appts continue, as does pain, imability to sleep through the night, particpate in activities involving physicial movement/action/walking. Especially difficult being without any compensation due to medical leave from work.				Y					N	11/29/2006	11/29/2006	0		UNK	UNK	Concerta 54mg PO Qd Paxil 20mg Provigol 200-300qd					1						1	Arthralgia; Asthenia; Blood glucose normal; Decreased activity; Dizziness; Feeling hot; Hypersensitivity; Impaired work ability; Insomnia; Nuclear magnetic resonance imaging; Pain; Respiratory depression; Dizziness; Fatigue; Heart rate increased; Muscular weakness; Respiratory rate decreased; Visual disturbance	FLU3~SANOFI PASTEUR~U2260AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~U2260AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Emergency room visit	Influenza
0268049	11/30/2006	MA	26.0	26		F	11/30/2006	My boyfriend and I both received the hepatitis A vaccine on 11/16/2006.  We both developed red, itchy, irritated skin one week following administration which has almost resolved.									Y	11/16/2006	11/22/2006	6	None	UNK	UNK		None	None			1						1	Erythema; Pruritus; Skin irritation	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~1~IM~RA~HEP A (NO BRAND NAME)~1	USA		Influenza
0268052	11/30/2006	WI	4.0	4		F	11/30/2006	11-30-06, 3:45PM CHILD WAS C/O PAIN AT INJECTION SITE. MOM CHECKED AND FOUND AREA 5 CM X 3.5 CM. RIGHT UPPER ARM RED, HOT, TENDER, RAISED AT INJECTION SITE OF DTAP.									Y	11/28/2006	11/30/2006	2		UNK	UNK						1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	DTAP~SANOFI PASTEUR~C2627AA~5~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2167RA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1031~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0707F~UNK~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0268053	11/30/2006	WY	61.0	61		M	11/30/2006	Called PH 3 days after getting flu vaccine. Stated that his arm was not sore, but did say that he had pain in the right side of his chest if I move just right, or when I cough. Advised him to contact his doctor to have pain checked out. Stated that he wasn't sure if pain related to flu shot or not.				Y					U	11/27/2006	11/29/2006	2		UNK	UNK		none				1						1	Chest pain	FLU3~SANOFI PASTEUR~U2218AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268054	11/30/2006	UT	57.0	57		F	11/30/2006	Hives on torso and upper arms.									Y	11/22/2006	11/23/2006	1		UNK	UNK	premarin	none	allergy: avocado, mold, grasses			1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69428~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268056	11/30/2006	CA	99.0	99		M	11/30/2006	Vaccine give 09:15, pt. noticed tongue swelling about 15:15 and reported to ward RN at 14:00 when swelling increased to lower lip then upper lip.  Unable to speak, lungs clear, no wheezing and maintained 02 Sat.  MD noticed - ordered 100mg Solumedrol IV and 25 mg Bendryl IM. Transferred to ER for monitoring.  Returned to ward same evening.				Y					Y	11/28/2006	11/28/2006	0		UNK	UNK	warfarin, senna, docusate sodium, fentanyl, bisacodyl, milk of magnesia, digoxin, atenolol, multivit with minerals, tamsulosin hydrochloride, hydrocodone/APAP, folic acid, cyanocobalamin, Alum/mag/sim	SSS, Afib, pacemaker, gout, BPH, HTN, +PPD, PVD	Levofloxacin			1						1	Face oedema; Speech disorder; Tongue oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA245BA~4~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0268057	11/30/2006	NV	64.0	64		M	11/30/2006	Pt came back 3 hours after immunization and had a swollen left Eye and itching throughout the body which also included some tingling in the extremeties.  No Anaphylactic shock was noted upon observing the patient.  Pt stated that the eye swelling was beginning to decrease at the time of presentation to the pharmacy.									Y	11/27/2006	11/27/2006	0		UNK	UNK	None known	None	None			1						1	Eye oedema; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601711~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0268058	11/30/2006	NJ	0.93	0	.9	F	11/29/2006	Developed Low grade fever 7 days post vaccination. Developed swollen hands and feet (right sided hands first then developed into bilateral swelling of both hands and feet). She was crawling and cruising furniture which ceased 10 days post injection. She was admitted and diagnosed with vasculitis of an unknown origin. She is pending a bone marrow biopsy to R/O Leukemia, but it is not probable.  Final result on duration, tx, outcome still pending. 12/12/06 Received medical records from hospital which reveal patient transferred from outlying hospital on 11/27/06 for bilateral swelling of hands & feet along with fever & decreased oral intake.  Temp on transfer was 102.2  D/C home on 12/1/06 to be f/u by rheumatolody & hematology.  D/C on tapering steroids Final DX: systemic inflammation; secondary dx included lupus anticoagulant & possible hereditary spherocytosis. Records did not include rheum or heme consults & requested again. 12/18/06 Received medical records from PCP which reveal patient was in good health but fussy/cranky with frequent spitting up from birth.  Well child on day of vax.  Next visit 11/25 had low grade fever, cranky & not sleeping or eating well for 2-3 days.  Exam revealed only that patient was teething & had an ulcer on the tip of her tongue.  Next note is from 12/4 after hospitalization & indicates resolving arthralgia & viral syndrome.  To be followed by rheum/heme as outpatient. 12/22/06 Received consults as requested & case closed. Final DX: Systemic inflammation; secondary dx: lupus anticoagulant; possible hereitary spherocytosis.				Y	Y	5			U	11/15/2006	11/22/2006	7	ESR 130 (HH) WBC 22.1 (H) RBC 3.35 (L) HbG 9.4 (L) HcT 26.6 (L) RDW 15.2 (L) Plt 780 (H) Mean Platelet Volume 7.0 (L) Lymphocytes 51 (L) Stool Culture Negative Blood Culture Negative Parvovirus B19 PCR Negative Ferretin 142 (H) D-Dimer 2.20 (H) PTT 56.8 (H) - 11/28 21:00 INR 0.98 (WNL)- 11/28 21:00 Fibrinogen 568 (H) PTT 49.7 (H) - 11/29 20:43 INR 1.01 (WNL) 11/29 20:43 U/A Unremarkable Echo - No coronary artery aneurysms noted - mild pericardial effusion CXR- Unremarkable - No infiltrates Physical exam: no rashes, no skin lesions, no lymph nodules, no diarrhea, vomiting.  Eyes: No uveitis, no conjunctivitis LABS: LP, bone marrow biopsy	UNK	UNK	N/A	None	None Birth Hx: 37 wk gestation by c-section w/elevated maternal BP at end of pregnancy.  Wt 6 lb 1 oz PMH: GERD, diaper rash, bronchitis, URI, viral syndrome, gastroenteritis.  In 6/06 letter indicates special formula medically necessary./ss			1						1	Laboratory test abnormal; Leukocytosis; Oedema peripheral; Pericardial effusion; Pyrexia; Spherocytic anaemia; Systemic lupus erythematosus; Vasculitis; Irritability; Oedema peripheral; Pyrexia; Red blood cell sedimentation rate increased; Sleep disorder	FLU3~SANOFI PASTEUR~U2248AA~1~SC~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0268065	11/30/2006	TX	41.0	41		M	11/30/2006	The day after vaccine receipt, experienced flu-like symptoms and new onset diplopia, dysphasia, dysarthria, paresthesia, some difficulty with urination, ataxia and gait imbalance. Presented to ER about 3 days later, where he was found to be relatively hypertensive (He had stopped his antihypertensive medications 1 week prior). Symptoms stabilized at that point. On exam, pupils unreactive, eyes conjugate in primary gaze, severe ophthalmoplegia with bilateral abduction deficits. Left facial weakness more prominent in lower distribution. Absent vibration throughout with exception of sternum and skull. Profound decreased proprioception in the lower extremities. Reflexes 0-4 through all extremities, plantars flexor bilaterally. Moderately ataxic with finger to nose testing, heel to shin testing. Diagnosed with Miller Fisher Variant of GBS. Treated with IVIG with some improvement of speech and swallowing capabilities by 11/22. Pt transferred to rehab facility. (This is initial VAERS report. Will file follow up report additional history and medical records obtained).  4/6/07 Received medical records from WRAMC which reveal patient experienced flu like symptoms on 11/9/06 one day after vax of fever, chills, gen body aches, diplopia, difficulty w/speech & swallowing, dysuria, paresthesias of extremities, gait & balance problems, fall.  Symptoms continued x 2 days & then went to ER.  ER exam revealed HTN (had not taken med x approx 1 wk).  Admitted to hospital on 11/12/06. Neuro exam revealed pupils unreactive, severe ophthalmoplegia, left facial weanesss, absent vibration throughout except sternum & skull, profound proprioception in LEs.  Reflexes were absent in all 4 extremities.  Ataxia.  Required intubation for 5--6 days.  Tx w/IVIG.  By 11/22 exhibited slow improvement in speech & swallowing.  Transferred to inpatient Rehab facility on 11/24 & d/c to home from there on 12/1/06 w/continued outpatient therapy.  As of 3/07, still had paresthesias of extremities & is being followed by neuro.  LABS: EKG revealed LVH & NSR.  CXR was WNL.  CT of head revealed right mca hyperdensity at sylvian fissure c/w thrombus. CSF 196 & WBC 33, c/s neg..  Barium swallow was abnormal & revealed aspiration. FINAL DX: Miller-Fisher variant of GBS in temporal association w/vax. Per information from annual follow up: 2/14/08-Spoke to patient on phone. Still having double vision inperiperal fields and having numbness & tingling in hands and feet. No vaccines since intial presentation. See attached neuro notes from 4/07 and PCM visit in 7/07. Patient was placed on temporary disability. See enclosed disablity determination and Narrative summaries.				Y	Y	10			N	11/08/2006	11/09/2006	1	Carotids bilat doppler study impression no hemodynamic stenotic lesion noted with minimal plaque formation involving the carotid arteries at the levels of the carotid bulbs. 11/12/06 MRI Brain w/o contrast, MRI brain MR angiography, circle of Willis PG impression 1 normal MRI of the brain and internal auditory canals with no evidence of acute ischemia. TOF MRA images of the intracrainal circulation demonstrate no evidence of right MCA thrombosis. There is a 1-2 mm inferiorly oriented vascular prominence present at the level of the anterio communication artery 11/12/06 CT, Head brain w/o contrast impression. There is subtle increased attenuation in the right M2 branch of the right middle cerebral artery when compared with the left. This finding may simply represent volume averaging in the slice in the background of an elevated hematocrit. However the presence of thrombus cannot be completely excluded in light of the pts symptoms. WBC 6.9, RBC 5.31, HH 16.2/47, PIT 371, 11/22/06 CSF protein 196. WBC 33, 11/21/06 GQ1B AB <1:100, 1/13/06 D1B GM1 autoantibody <1:800, CSF WBC 16 (H), SEG 1%, Lymphs 76%, Mono 23%, Protein 34 (15-45), Gram stain no organism seen. Moderate WBC's. Cryptococcus AB neg, 11/12/06 GLU 98, Bun/CR 14/0.2, NA 139, CL 103, K 3.2, CA 9.1, CK MB 0.7, Troponin U 0.02, Myoglobin 33.2 (17.4-105.7) CK 90, MG 2.4, CBC-WBC 12.8, RBC 5.97, H/H 18/52.3, PLT 496, Lymph 15.8%, Mono 5.7%, EOS 1.9%, Baso 0.2%, MPV 7.7.	MIL	MIL	At time of vaccine had just stopped HCTZ 1 week prior to vaccine. Was taking Welbutrin 150 mg BID.		Hypertension No Known Drug Allergies. PMH: HTN, smoker.			1						1	Angiogram; Asthenia; Blood creatine phosphokinase; Condition aggravated; Coordination abnormal; Diplopia; Dysarthria; Dysphagia; Dysphasia; Dysuria; Gait disturbance; Gaze palsy; Hypertension; Hypoaesthesia; Influenza like illness; Laboratory test abnormal; Miller Fisher syndrome; Nuclear magnetic resonance imaging brain; Pain; Paraesthesia; Paraesthesia; Scan brain; Sensory disturbance; Speech disorder; Ultrasound Doppler; White blood cell count increased	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TYP~SANOFI PASTEUR~500440P~3~~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Hospitalisation	Influenza
0268070	11/30/2006	NY	76.0	76		F	11/30/2006	Right arm pain following injection, next day arm pain, swelling redness.  Recommended treatment ice and NSAIDS.									U	11/28/2006	11/28/2006	0		PVT	PVT						1						1	Erythema; Injection site pain; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F62311~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0268072	11/30/2006	OR	50.0	50		F	11/30/2006	One hour after inoculation, I experienced swelling in right neck area - gland, tender and swollen walnut size - diminished next day but still swollen and tender.									U	11/29/2006	11/29/2006	0		OTH	PVT	Lipitor 10mg a day	NONE	NKA			1						1	Lymphadenopathy; Tenderness	FLU3~SANOFI PASTEUR~U2240AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268064	12/01/2006	CA	69.0			F		A report was received from a healthcare professional on 15/Nov/2006 concerning a  unidentified vaccinee.  No other details were provided at this time.  Further information was received on 28/Nov/2006 from the same healthcare professional concerning a 69-year-old female vaccinee. The vaccinee has a history of diabetes, no details concerning concomitant medications were provided.  On 03/Nov/2006 the vaccinee received Fluvirin in the left deltoid.  Eight days later she awoke in the night with severe left arm pain which did not resolve. The following day 11/Nov/2006, the vaccinee attended the emergency room where investigations were carried out to elicit the cause of the pain, a treadmill stress test, cardiac enzymes, glucose reading, X-ray of the C-spine and CT scan were performed and were all reported with TYLENOL #3 with codeine which had no effect, and Morphine which resulted in an itchy rash, but no pain relief.  TORADOL was then administered with pain relief 1 hour, and was repeated a number of times.  On 13/Nov/2006 the vaccinee pain resolved, the itching and rash had also resolved, and she was discharged from hospital.  No cause was found for the left arm pain, and the vaccinee has had no recurrence.  A copy of the hospital discharge summary has been requested.					Y	0				11/03/2006	11/11/2006	8		UNK	UNK	Concomitant drugs not reported.		Diabetes		CVOX200600672	1						1	Injection site pain; Pain; Rash pruritic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72002~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0268067	12/01/2006	IN	39.0	38		F	11/27/2006	generalized rash				Y					Y	11/22/2006	11/25/2006	3	None	MIL	PVT			seasonal allergies			1						1	Rash	FLU3~SANOFI PASTEUR~U2239AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268081	12/01/2006	ND	5.0	5		F	11/24/2006	Pt ran high fever of 103 for 3 days following influenza injection (1st dose received, fever started following day).									Y	11/09/2006	11/10/2006	1		OTH	OTH	NONE	NONE	Allergy to nuts, cashews		ND0617	1						1	Pyrexia	FLU3~SANOFI PASTEUR~7200~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268082	12/01/2006	TX	40.0	40		F	11/22/2006	Patient called today describing not feeling well right after she left our store. She had some breathing difficulty, hand swelling, heart irregularities and dizziness. She said that today 11-22-06 she is feeling better. I recommended that she see a physician if needed. Symptoms ended.									Y	11/16/2006	11/16/2006	0		OTH	PVT		NONE	Asthma			1						1	Arrhythmia; Dizziness; Dyspnoea; Malaise; Oedema peripheral	FLU3~SANOFI PASTEUR~U2258AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268083	12/01/2006	TX	74.0	74		F	11/26/2006	Arm swollen from shoulder to below elbow. Fever in arm, painful and sore to touch. I felt sick for two days after shot.									Y	11/02/2006	11/02/2006	0		OTH	OTH	Lisinopril 5 mg, Lipitor 20 mg, Lavothyroxin 50 mg, Actonel 35 mg, Omega 3, Fish oil					1						1	Malaise; Pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U2216AA~5~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0391F~2~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268094	12/01/2006	WI	72.0	72		F	11/28/2006	Initial report received on 22 November 2006 from an investigator participating in the above-mentioned trial. A 72-year-old female subject with history of Crohn's disease was diagnosed with exacerbation of Crohn's disease, 9 days after she had received a first dose, right arm, intramuscular injection of Influenza Virus Vaccine USP Trival A & B, High dose, Subvirion-U, lot number not reported, on 25 October 2006. Her medical history also included: osteoarthritis, glaucoma, vascular headaches, vasomotor rhinitis, labile blood pressure, asthma, nephrolithiasis, hyperglycemia, gastroesophageal reflux and dyspepsia, cholecystectomy. Concomitant treatments were Combivent, Advair, Prilosec, Potassium, timolol. On 27 November 2006, two days post-vaccination, the subject experienced diarrhea and nausea that lasted 9 days, until 06 November 2006. On 03 November 2006 the subject experienced hypokalemia that lasted a day, until 04 November 2006. The subject was admitted to the hospital on 03 November 2006 and discharged on 06 November 2006. The subject was treated with Prednisone 40 mg daily, mesalamine 1200mg 4 times a day and IV fluids with potassium chloride. The subject had recovered. Important laboratories results done at the hospital: C-Diff toxin-negative; feces culture- no E.coli or salmonella; stool for WBC's-negative; chemistry panel-normal, Hemogram + PLT + Autodif + WBC-High; Lactate-normal. The subject continued in the study trial. According to the investigator, the event was related to the study vaccine. Documents held by sender: hospital admission and discharge summaries and laboratory results.					Y	4			Y	10/25/2006	11/03/2006	9	Laboratories results done at the hospital C Diff toxin neg, Feces culture no E coli or salmonella, stool for WBC's neg, chemistry panel normal, Hemogram + PLT + Autodif + WBC high. Lactate normal.	OTH	OTH	Combined Diskus, timolol, Advair, Prilosec, Potassium citrate, Multivitamins, Combivent.		History of Crohn's disease		200603221	1						1	Condition aggravated; Crohn's disease; Diarrhoea; Hypokalaemia; Laboratory test abnormal; Nausea	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0268103	12/01/2006	WA	64.0			F	12/01/2006	This case was reported by a healthcare professional and described the occurrence of injection site rash in a 64 year old female subject who was vaccinated with Influenza virus vaccine Trivalent (FluLaval) for prophylaxis. The subjects medical history included acquired immune deficiency syndrome. On 10/23/06 the subject received a dose of FluLaval in an unspecified arm. The healthcare professional noted that at the site of the FluLaval injection, on 10/30/06, 7 days after vaccination with FluLaval, subject experienced a breakout of rash on the arm of the injection site with a black dot in the middle of the injection site. The subject was seen on 11/17/06 at a physicians office and was treated with Benadryl. The healthcare professional considered the events were clinically significant (or requiring intervention) (OMIC). The outcome of the events was not reported.				Y					U	10/23/2006	10/30/2006	7		PVT	PVT			Acquired Immune Deficiency Syndrome; The healthcare professional reported that 4 other subjects experienced injection site reactions following receipt of FluLaval from lot 2F600311. Please see cases A0628866A, A0628871A, A0628872A, and A0629026A		A0628870A	1						1	Injection site rash; Skin discolouration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F600311~UNK~~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0268104	12/01/2006	WA	42.0			M	12/01/2006	This case was reported by a healthcare professional and described the occurrence of injection site rash in a 42 year old male subject who was vaccainted with FluLaval for prophylaxis. On 11/17/06 the subject received a dose of FluLaval in an unspecified arm. On 11/17/06, the subject also received hepatitis A vaccine (Havrix), Typhim VI and and unspecified vaccine. The healthcare professional noted that at the site of the Flulaval injection, on 11/17/06, 0 days after vaccination with FluLaval, the subject experienced a breakout of rash on the arm of the injection site with a black dot in the middle of the injection site. The subject was seen at a physicians. Office and was treated with Benadryl. The health care professional considered the events were clinically significant (or requiring intervention) (OMIC). The outcome of the events was not reported.				Y					U	11/17/2006	11/17/2006	0		PVT	PVT					A0629026A	1						1	Injection site rash; Skin discolouration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F600311~UNK~~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~UN~HEP A (HAVRIX)~1|TYP~SANOFI PASTEUR~~UNK~PO~MO~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|UNK~UNKNOWN MANUFACTURER~~UNK~~UN~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0268112	12/01/2006	TX	28.0	27		F	12/01/2006	Patient complained of body aches, chills, fever, soreness at site of injection.									Y	11/30/2006	11/30/2006	0	Not known	PVT	PVT	Singular, Prozac, Zyrtec, Birthcontrol, Ambien, Albuterol, Advair, Flonase	None	Asthma, bronchitis			1						1	Chills; Injection site inflammation; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71827~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0320F~1~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268113	12/01/2006	VA	15.0	14		M	11/30/2006	Pink skin color change around shot site with tenderness. Some streaking reported. No fever, vomiting, abdominal pain, breathing difficulties.				Y					U	11/28/2006	11/29/2006	1	None	PVT	PVT	None	None	chest wall deformity-age 14-normal chest CT			1						1	Injection site erythema; Tenderness	FLU3~SANOFI PASTEUR~U2260AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268114	12/01/2006	VA	12.0	11		F	11/30/2006	Pink skin color change around shot site with tenderness. Some streaking reported. No fever, vomiting, abdominal pain, breathing difficulties.									U	11/28/2006	11/29/2006	1	None	PVT	PVT	None	None	None			1						1	Injection site erythema; Tenderness	FLU3~SANOFI PASTEUR~U2260AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268115	12/01/2006	VA	13.0	12		M	11/30/2006	Pink skin color change around shot site with tenderness. Some streaking reported. No fever, vomiting, abdominal pain, breathing difficulties.									U	11/28/2006	11/29/2006	1	None	PVT	PVT	None	None	Bilateral club feet-repaired as infant			1						1	Injection site erythema; Tenderness	FLU3~SANOFI PASTEUR~U2260AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268116	12/01/2006	CA	36.0	35		F	11/22/2006	Patient states that 2 hours after vaccine administration rash developed on forehead and sides of face. No other rash site. No shortness of breath or other symptoms. Patient applied topical Benadryl with some relief. Reported to us 11/22/06. Temp oral 95.7F.									U	11/17/2006	11/17/2006	0	None	OTH	PUB	Levaxil 1.0, Ovacon 35/28	None	Thyroid problem/sinus allergies			1						1	Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601311~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268117	12/01/2006	NH	3.0	3		F	12/01/2006	Patient developed swelling, redness, blisters at site.									Y	11/29/2006	11/29/2006	0		PVT	PUB		None	None			1						1	Erythema; Injection site vesicles; Swelling	FLU3~SANOFI PASTEUR~U2275AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268118	12/01/2006	NH	74.0	73		M	11/30/2006	Patient had a bad reaction to shots at clinic, Nov 15th 18:30 Patient received a flu shot and pneumonia update shot. 22:30 very sore swollen left shoulder. 23:30 difficulty getting into bed due to very sore arm. Headache and aching all over feeling. Nov 16-0700 less soreness, able to move arm to get out of bed. I assumed it would be better in a day. Headache remains. Headache is not severe but dull and continuous. Nov 17 soreness and headache continue. Nov 18 working with scouts-picked up a food bad and stood up quickly, a bright aura or light show in left eye. Went inside and sat down until it cleared (about 10 minutes). [Lights continued with eye closed-could not see thru the silver gray pulsating fields.] Nov 19 mild aura just sitting on bed-about 3 minutes. Nov 20 at mall walked out of rest room-big aura called Dr. while it happened. Saw Dr. 2 hours later- he found no problem. Nov 21-27 about one event per day-3 to 10 minutes. Most in left eye, once in both eyes simultaneously. Difficulty sleeping with the headache-at night patient has been taking Ibuprofen, 400 mg it helps but lasts about 4 hours. No apparent correlation to activities and onset. Patient thought it might be blood pressure spikes, but several have occurred while sitting. The headache continues as patient is typing this. Interesting note-the nasal drainage has been a lot less during this episode. Patient mentions they have had ocular migraines where they get squiggle in vision that can last 10 minutes. 2-3 episodes over the last 5 years.  This is different. No arm or leg symptoms.				Y					Y	11/15/2006	11/15/2006	0	US carotid duplex, 11/19/06: sed rate, complete blood count, blood urea nitrogen, creatinine, CT brain scan with and without contrast. History: Intermittent vision loss. Serial axial imaging from the base of the skull to the top of the convexities is performed, both pre- and post administration of 100 cc of Omnipaque-300 intravenous contrast. The ventricles are within normal limits in size. There is no shift of the midline structures. No focal areas of abnormality are clearly defined. However, a small fleck of high attenuation representing calcification is seen in the distribution of the basal ganglia on the right, most likely at the globus pallidus. Impression: Negative examination.	PVT	PVT	Prednisone, Lisinopril-Hydrochlorothiazide, Norvasc, Calcium 500 with Vitamin D.	None	Left and right inguinal hernias, L inguinal hernia repair 1966, high blood pressure, hypertension, Tubular adenoma 9/98			1						1	Halo vision; Headache; Hypokinesia; Insomnia; Pain; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA208BA~6~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0985F~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0268119	12/01/2006	CO	53.0	53		F	11/30/2006	for 24 hours I was drained of energy and unable to get out of bed.  My legs were especially painful, but my whole body was achy and uncomfortable.  I was dizzy when I had to get up and feared fainting.  I am a healthy 53 yr old and usually nothing keeps me from being productive and working hard each day.  This is a feeling I never want to experience again.									Y	11/28/2006	11/29/2006	1		UNK	UNK		none	none			1						1	Asthenia; Dizziness; Pain	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268120	12/01/2006	CA	7.0			M	12/01/2006	Fever up to 104.3F Taken Orally from the date of vaccination to 2 days later. Children's Tylenol was given.				Y					Y					UNK	UNK		None	None			1						1	Pyrexia	FLU3~SANOFI PASTEUR~U2244AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268121	12/01/2006	MD	35.0	35		M	12/01/2006	DEVELOPED MODERATE INFLUENZA SYMPTOMS AS IF I WAS HAVING THE FLU ITSELF WITH FEVER, CHILLS, DIFFUSE MYALGIAS, SORE THROAT AND NASAL CONGESTION WITHIN 24 HOURS OF RECEIVING THE LIVE INTRANASAL INFLUENZA VACCINE.  THIS INCLUDED HEADACHE.  THE FOLLOWING DAY, SYMPTOMS RESOVLED, BUT WERE QUICKLY REPLACED BY UPPER RESPIRATORY INFECTION SYMPTOMS WITHOUT FEVER WHICH LASTED FOR 10 DAYS.  THESE INCLUDED RHINORRHEA, NASAL AND EAR CONGESTION, OTALGIA, MODERATE HEARING LOSS, LARYNGITIS, CHRONIC DRY COUGH.  ON DAY 7 POST VACCINATION, I WOKE IN THE MIDDLE OF THE NIGHT WITH SIGNIFICANT EPISTAXIS WHICH TOOK NEARLY 5 HOURS TO STAUNCH.  ALTHOUGH I DID NOT SEEK MEDICAL TREATMENT, MY IMPRESSION WAS THAT THE BLEEDING WAS POSTERIOR AND STOPPED OF ITS OWN ACCORD EVENTUALLY.  MILDER INTERMITTENT EPISTAXIS PERSISTED FOR 4 DAYS.  I DO NOT KNOW WHAT TOTAL BLOOD LOSS WAS OR IF I DEVELOPED AN ANEMIA AS A RESULT.									Y	11/06/2006	11/07/2006	1	NONE	MIL	MIL	ATENOLOL 25MG PO QD	NONE	HYPERTENSION			1						1	Chills; Cough; Epistaxis; Headache; Hearing impaired; Influenza like illness; Laryngitis; Myalgia; Nasal congestion; Pharyngolaryngeal pain; Pyrexia; Rhinorrhoea; Upper respiratory tract infection	FLUN3~MEDIMMUNE VACCINES, INC.~500439P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0268122	12/01/2006	AZ	67.0	67		F	12/01/2006	Arm red and swollen down to the elbow and all the way around, chills, Went to 1st Dr. (he did not look at it but said to take Benadryl and put ice on it. Had another appt. with a different Dr. that day and he would not treat me for my knee injury until the arm was better, he then gave me antibiotic 'Cephalexin 500 MG'. Then went to ER later that nite, told to keep it elevated and rechecked in several days.				Y					Y	11/29/2006	11/29/2006	0		UNK	UNK		None				1						1	Chills; Erythema; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0268123	12/01/2006	MI	54.0	54		F	12/01/2006	Husband called to report client experienced nausea, severe headache after flu shot, lasting approximately 3 days.									Y	11/13/2006	11/13/2006	0		UNK	UNK	None given	No	No			1						1	Headache; Nausea	FLU3~SANOFI PASTEUR~U2247AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268125	12/01/2006	MI	65.0	65		F	12/01/2006	Shoulder Pain									Y	10/11/2006	10/11/2006	0	None	UNK	UNK	Unknown	No	Unknown			1						1	Shoulder pain	FLU3~SANOFI PASTEUR~U2256AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268126	12/01/2006	GA	4.0	4		F	12/01/2006	CHILD STARTED C/O BOTTOM OF FEET ITCHING WITHIN 5 MINUTES OF RECEIVING INJECTIONS. WITHIN 15 MINUTES RED RASH NOTED ON FACE, TRUNK, ARMS AND CHILD WAS C/O ITCHING ALL OVER. WHELPS NOTED ON ARMS. BENADRYL 6.25MG IM GIVEN. AFTER 30 MINUTES RASH WAS RESOLVING. CHILD NO LONGER C/O ITCHING. ALL WHELPS GONE EXCEPT 1 ON THE LEFT FOREARM.									Y	12/01/2006	12/01/2006	0	N/A	MIL	MIL		NONE	PREMATURE BIRTH (24 WEEKS), BLINDNESS OF RIGHT EYE, DEVELOPMENTAL LANGUAGE DELAY, DEVELOPMENTAL MOTOR DELAY, CONGENITAL HEARING LOSS.			1						1	Erythema; Pruritus; Rash; Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B042BA~5~IM~LA~DTAP (INFANRIX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72001~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~Y1030~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0700F~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0268128	12/01/2006	VT	1.01	1	.0	F	12/01/2006	Immunized yesterday after pe, last night 20 minutes after going to bed breathing funny, in emesis, unresponsive. Called 911. 73% O2 100% . Transport uneventful. Unresponsive to painful stimuli.T 98.9 at ER. O2 83% on room air. Resp shallow.Eyes deviated & sluggish to react. Tachycardiac @180. CXR nl. UA glucose. BS 171. Intubated.Ativan & rocephin admin. Then grand mal seizure. Improved after 20 min. WBC 20.10.Extubated prior to transfer. Transfered to hospital. fine stable  Hx febrile seizure in past.   12/19/06 Received medical records from 2nd hospital which reveal patient admitted 12/1/06-12/2/06.  At initial hospital patient was found to be actively seizing & was treated and transferred to PICU.  Temp 102.5 on admit. Neuro exam at 2nd hospital found WNL & no further seizure activity noted.  To be followed by peds neuro outpatient & have repeat MRI.   Final DX: Febrile seizure.					Y	2				11/30/2006	11/30/2006	0	LABS: EEG was WNL.  Blood cultures neg.  Labs at initial hospital revealed WBC 24.1	UNK	UNK	none	None	Febrile seizure history Birth HX: F/T vaginal, no complications. PMH: febrile seizures 8/06.		20061201	1						1	Coma; Condition aggravated; Febrile convulsion; Hypoventilation; Respiratory disorder; Sluggishness; Strabismus; Tachycardia; Vomiting; White blood cell count increased	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B056AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U220FA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE946AA~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B08503B~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0268129	12/01/2006	MI	71.0	71		M	12/01/2006	Sore arm immediately									Y	10/20/2006	10/20/2006	0	None	UNK	UNK	Unknown	No	Unknown			1						1	Pain	FLU3~SANOFI PASTEUR~U2213AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268130	12/01/2006	MI	62.0	62		F	12/01/2006	redness, swelling, heat in area.									U	11/28/2006	11/28/2006	0		UNK	UNK						1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2307AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268132	12/01/2006	MI	27.0	27		F	12/01/2006	Redness, swelling, heat.									U	01/28/2006	11/29/2006	305		UNK	UNK		no				1						1	Erythema; Injection site warmth; Swelling	FLU3~SANOFI PASTEUR~U2307AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268133	12/01/2006	MI	31.0	31		F	12/01/2006	Redness, swelling. Cellulitis. Treated with Keflex, Motrin.				Y					U	11/28/2006	11/28/2006	0		UNK	UNK						1						1	Cellulitis; Erythema; Swelling	FLU3~SANOFI PASTEUR~U2307aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268137	12/01/2006	OR	2.0	2	.0	M	12/01/2006	HISTORY OF PRESENT ILLNESS:  In today for evaluation of a rash.  He was seen yesterday for his routine well care and administration of the flu shot.  Mom reports she noticed the rash between the first and second time she changed his diaper this morning.  He does not seem uncomfortable with itching.  She reports she notes it on his upper legs bilaterally, particularly on the thighs, and she thinks it is more prominent on the left side where he received his flu shot as opposed to the right.  She also notices it on his abdomen and states that it is a red raised bumps.    He is currently towards the end of a course of Augmentin for sinusitis and seems much improved and he had his flu shot yesterday, which mom is concerned that is the cause of the rash.  He is otherwise acting well.  He does not have fever.  As mentioned above, he does not seem uncomfortable with itching or discomfort from the rash.  CURRENT MEDICATIONS:  Augmentin.  ALLERGIES:  No known drug allergies.   PHYSICAL EXAMINATION:  VITAL SIGNS:  Weight was 14.6 kg yesterday.  GENERAL:  He is alert and well appearing.  A limited examination is performed.  SKIN:  He has a scattered slightly raised papular rash that is erythematous and blanches and it is fairly sparsely scattered over the front of his abdomen and down into the pubic area, also noted on his legs, primarily the anterior thighs and it seems a  little more concentrated on the left thigh compared to the right, but not greatly so. These are not typical hives.  They do blanch.  There is no purplish discoloration.  There are no scratch marks, and he does not appear to be uncomfortable.  Dr. also examined the rash.  IMPRESSION:  Rash, most likely consideration Augmentin associated or possible early allergic rash versus a localized reaction from his flu shot, but this seems less likely.   PLAN We will have at this point mom discontinue the Augmentin, since he is so close to the end of his course.  She will watch the progression of the rash and hopefully resolution of the rash over the next 2-3 days.  We did discuss dosing of Benadryl.  He could have 1 teaspoon of liquid Benadryl q.6-8h. p.r.n. for itching should he become uncomfortable, but otherwise I would simply observe the rash. We discussed the use of Augmentin or penicillin-based products in the future, and I think those could be retried with caution and close observation. Mom also asked about whether he should receive the second half of his flu shot in a month and I recommended that, again with observation, since he has no documented egg allergy.  With other concerns, she will call.  Otherwise, second half of flu shot in 1 month.									Y	11/13/2006	11/14/2006	1	None obtained	UNK	UNK	Augmentin	Sinusitis	None			1						1	Pruritus; Rash; Rash erythematous; Rash papular	FLU3~SANOFI PASTEUR~U2175AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268138	12/01/2006	CA	67.0	66		F	12/01/2006	CLIENT DEVELOPED 5CM OF ERYTHEMA AND INDURATION AROUND SITE OF INJECTION OF THE FLU VACCINE RIGHT DELTOID AREA, WARM TO PALPITATION.									Y	10/09/2005	10/11/2005	2	NONE	UNK	UNK	ATORVASTATIN, LACUTLOSE, DSS, LANSOPRAZOLE, METOCLOPRAMIDE,CALCIUM WITH VIT d, DESONIDE CR, SELENIUM SULFIDE	NONE	PROFOUD MENTAL RETARDATION, ASYMPTOMATIC BRADYCARDIA, HYPERCHOLESTEROLEMA, BARRETT'ESOPHS,SEBORRHEA,  EOSINOPHILIA, REACTIVE AIRWAY DISEASE.			1						1	Injection site erythema; Injection site induration; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA138AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268139	12/01/2006	FL	57.0	57		F	12/01/2006	MALIASE SORE THROAT LARGE HIVES ON FACE AND TRUNK ITCHY ENTIRE BODY									U	11/24/2006	11/26/2006	2		UNK	UNK		NONE		11/26/2006~Influenza (Seasonal) (no brand name)~1~0.00~In Patient		1						1	Malaise; Pharyngolaryngeal pain; Urticaria	FLU3~SANOFI PASTEUR~U2254AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268148	12/01/2006	MS	1.13	1	.1	F	11/15/2006	Developed red rash on arms and legs beginning on 10/26 (3 days after vaccines given)-presented to office 10/17/05 with erythema multiforme minor (no mucosal involvement)-no fever.				Y					U	10/23/2006	10/26/2006	3	None	PVT	PVT	Clindamycin, Zyrtec, Bactroban, Xopenex	runny nose no fever	adopted from China 9/06; bronchiolitis, staph skin infection			1						1	Erythema multiforme; Rash	FLU3~SANOFI PASTEUR~U2101DA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB289CA~2~IM~RL~HEP B (ENGERIX-B)~1|IPV~SANOFI PASTEUR~Y1032~2~IM~RL~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0268149	12/01/2006	WI	51.0	51		F	12/01/2006	Flu vaccine given at 2pm. Patient reports at 9pm right side of face and throat numb (describes some feeling as with dental anesthesia). Trouble swallowing and swelling. Took antihistamine and symptoms resolved over next 24 hours.									Y	11/28/2006	11/28/2006	0	None	OTH	PVT	Capaxone	None	Multiple sclerosis			1						1	Dysphagia; Hypoaesthesia; Swelling face; Throat tightness	FLU3~SANOFI PASTEUR~U2283AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268140	12/02/2006	MA	54.0	54		F	12/02/2006	Within 6 hours, sore throat; 24 hours conjunctivitis, then full blown head/chest cold.									Y	11/29/2006	11/29/2006	0		UNK	UNK						1						1	Conjunctivitis; Pharyngitis; Rhinitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0268141	12/03/2006	CT	56.0	56		F	12/03/2006	Within 24 hrs of vaccination, there was significant discomfort in the shoulder and clavicle area on side of injection. The lymph nodes in the area above the clavicle were felt as hard round lumps and tender to the touch.  Discomfort continued for 5 days with swelling of nodes slowly decreasing over that time.   Acetaminophen and Naproxen were used to control discomfort with questionable success.									Y	10/27/2006	10/27/2006	0		UNK	UNK	zyrtec,naproxen,prevacid,folgard,glucosamin/chondroitin,calcium, magnesium, centrum silver,vitamins c,d,e,b complex	none	seanonal allergies, osteopenia			1						1	Discomfort; Lymphadenopathy	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0268142	12/03/2006	CA	39.0	39		M	12/03/2006	I received the Flu Mist at 4:00 PM on 2 Deck 2006, after leaving and arriving home at 7:30pm i felt nausea and a headache.  By 8:30PM I was vomiting which continued until approx 4:am on 3 Dec 2006.									Y	12/02/2006	12/02/2006	0		MIL	MIL	None	None	None			1						1	Headache; Nausea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500440P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0268144	12/03/2006	DE	36.0	36		F	12/03/2006	LEFT ARM INJECTION SITE: RED, SWOLLEN AREA CIRCUMFERENCE OF APPROX 3 IN DIAMETER. NO PAIN, ITCHING OR DISCOMFORT.   SUGG: ICE TO THE AREA AND OTC ANTIHISTIMINE. FOLLOW-UP:  12-5-06										12/03/2006	12/03/2006	0		MIL	MIL						1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2308AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268058	12/04/2006	NJ	0.93	0	.9	F	11/30/2006	Initial case received on 11/28/06 from the pts parent. An 11 month old female pt had received in injection of Fluzone SV (specific product not reported), lot number not reported, route and site of administration not reported, on 11/15/06. Seven days post vaccination, the pt experienced a low grade fever, irritability, and change in sleep pattern. Four additional days later, she developed swelling of the feet and  hands. The pt was examined in an emergency room and subsequently admitted to the hospital. A sedimentation rate elevated (results not provided). At the time of this report, the pt had not recovered.					Y	0			N	11/15/2006	11/22/2006	7		UNK	UNK					200603268	1						2	Laboratory test abnormal; Leukocytosis; Oedema peripheral; Pericardial effusion; Pyrexia; Spherocytic anaemia; Systemic lupus erythematosus; Vasculitis; Irritability; Oedema peripheral; Pyrexia; Red blood cell sedimentation rate increased; Sleep disorder	FLU3~SANOFI PASTEUR~U2248AA~1~SC~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0268145	12/04/2006	TX	2.0	2	.3	F	12/01/2006	Onset of leg pain, 2 days after influenza vaccine on 11/11/2006, weakness with walking on about 11/13/06, increased difficulty walking starting about 11/24/06. Hospitalized 1/27/06 and diagnosed with Guillian Barre Syndrome.  12/12/06 Received medical records from hosptial which reveal patient admitted 11/27/06 after developing acute progressive distal to proximal weakness over a 2 wk period prior to admit.  Difficulty climbing stairs & walking funny, complaining that whole body hurt.  Symptoms began 2 days s/p flu vax.  Also had URI symptoms with low grade fever & was seen in ER approx 2 wks prior to admit & was placed on antibiotics & inhaler for wheezing.  Tx w/IVIG & responded very well.  Consults by Neuro & ID.  Noted to have tremors of upper extremities. DTRs absent in LEs.  Gait was wide based & slow.  Continued to improve & was d/c to home on 12/1/06. Final DX: Guillain Barre syndrome.					Y	4			Y	11/09/2006	11/13/2006	4	tendon reflexes upper extremities, absent DTR in LE's. CSF protein 65 ml/dl, (Nl 15-60), CSF glucose nl, CSF WBC 3. Head CT normal, MRI L Spine, anterior nerve root enhancement consistent with GBS.  LABS: CSF showed cytoalbuminic dissociation with glucose 58 & protein 65.  MRI of LS spine revealed enhancement of nerve roots consistent w/GBS.  WBC 12,000, 63 lymphs, eos 12. All c/s were neg.	PVT	UNK		Sinusitis	Birth Hx: 36 wk 4 lbs 15 oz.  Developed well.  Mother has diabetes. PMH: croup at 1 year, herpetic gingiva stomatitis at 16 mos.  Cough & runny nose allergy symptoms for approx 3 mos.			1						1	Asthenia; CSF test abnormal; Difficulty in walking; Guillain-Barre syndrome; Hyporeflexia; Pain	FLU3~SANOFI PASTEUR~U2196AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0268147	12/04/2006	WA	1.08	1	.1	M	12/02/2006	L5 distribution VZV immunization related shingles. Acychovse for 5 days.									U	11/29/2005	11/24/2006	360	None	PVT	PUB		None				1						1	Herpes zoster	FLU3~SANOFI PASTEUR~U1788EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0515R~3~IM~RL~HEP B (FOREIGN)~1|VARCEL~MERCK & CO. INC.~0393R~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0268163	12/04/2006	MI	67.0	67		F	11/20/2006	Received PP23 vaccine 11/15/2006. right arm became swollen, warm to touch 11/15/2006pm, on am 11/16 client observed swelling from shoulder to below elbow, dark discoloration and fluid under skin to wrist, deltoid hot to touch, came into clinic to advise, referred to PP seen 11/16/06 per PP. states given Keflex, Bactrim for infected arm, arm continued to swell. Fri  11/17/06 hospitalized for IV antibiotics, released 11/19/06 on oral antibiotics Augmentin. RTC to PP in 1 week.  MR received from hospital stay of 11/17-18/2006 for c/o redness, swelling, and pain in the right deltoid following Pneumovax, which had not responded to oral antibiotics.  HPI: The evening of her Pneumovax pt. began to notice redness and swelling of the right deltoid area.  OV to PCP the following day where Keflex and Bactrim were prescribed.  Redness, swelling, and pain were increasing and spreading to the lower arm despite antibiotics.  Pt. developed chills and nausea on day 2 s/p vax. She was then refered to the ER by her PCP for IV antibiotics.  Impression:  Spreading erythema, swelling, and pain 2' to right upper extremity cellulitis, not responding to outpatient antibiotics.  COPD-stable. Hx. of Rectal carcinoma.  Peripheral Vascular Disease.				Y	Y	2			Y	11/15/2006	11/15/2006	0	Labs and Diagnostics: Labs-unremarkable.  Blood cultures negative. CXR c/w Emphysema, CHF.	PUB	PVT	Meds: Albuterol.		Emphysema. PMH: 67 yr old with COPD, hx. of rectal cancer, peripheral vascular disease, hx. of kidney stones and ? peptic ulcer disease.  Allergies: Morphine.			1						1	Fluid retention; Injection site infection; Injection site oedema; Injection site warmth; Skin discolouration	FLU3~SANOFI PASTEUR~SPU2178AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1044P~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0268165	12/04/2006	IL		93		F	11/07/2006	Bruising at site of injection. Possible minor infection at site. Treatment: Neosporin topical-covered with bandage for 2-3 days.									Y	11/03/2006	11/07/2006	4	Unk	OTH	OTH	Lexapro, Zelnon, Lipitor, Alpraxone,  Sytthrouy	None				1						1	Contusion; Infection	FLU3~SANOFI PASTEUR~U2274AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268166	12/04/2006	WI	61.0	61		F	11/21/2006	Has history of allergic reaction to wine and wine vinegar. Reported puffiness of face, tightness in throat and visual changes. Came to occupational health service area immediately. Benadryl given (25mg) with response. Returned to work. Shot given at 12:55; symptoms began at 2:15pm.									Y	11/02/2006	11/21/2006	19	None	OTH	PVT	blood pressure	None	wine and wine vinegar allergies			1						1	Hypersensitivity; Swelling face; Throat tightness; Visual disturbance	FLU3~SANOFI PASTEUR~U2258AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268167	12/04/2006	MN	8.0			M	11/24/2006	Large local reaction L arm deltoid to middle of upper arm, raised, hot, also wheezed. Has had flu shot before with no significant problems. No egg allergy.									Y					PVT	PVT	Albuterol PRN, pulnicort with cold	None	Asthma			1						1	Feeling hot; Injection site reaction; Wheezing	FLU3~SANOFI PASTEUR~U2202AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268169	12/04/2006	OH	75.0	75		M	11/20/2006	Rash, patches on body, chest, back, abdomen and legs.  Patient went to primary care physician who gave patient an injection of cortisone and Clarinex 5mg pills for the rash and itching.				Y					Y	11/14/2006	11/14/2006	0		OTH	PUB						1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U2238AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268170	12/04/2006	MO	90.0	89		F	11/27/2006	Entire right arm site of pneumovax was edematous/erythematous, no other rashes ore edema (had flu vaccine in left arm). Resolved when seen 1 week later.									Y	11/20/2006	11/20/2006	0	Exam only	PVT	PVT		NONE				1						1	Injection site erythema; Injection site oedema; Injection site reaction	FLU3~SANOFI PASTEUR~U2283AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0881f~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268171	12/04/2006	NY	62.0	62		F	11/27/2006	On 11/22/06 client developed hives on left cheek red raised area, very itchy, she had stated she was very stressed at her job, on 11/23/06. Woke up to find approx 10-12 water blisters that broke open and oozed. Cleansed area with Bactine and applied Benadryl cream and antibiotic ointment. 11/27/06 areas are drying up and fading client did not see doctor.									Y	11/22/2006	11/22/2006	0		OTH	PVT	Blood pressure medications.	NONE	High blood pressure			1						1	Blister; Pruritus; Rash erythematous; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71643~4~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268172	12/04/2006	CA	58.0	58		F	11/09/2006	Dizziness upon rising 7am Nov 4, 2am Nov 5, 8am Nov 5, 7am Nov 6, Dizziness lying down 10am Nov 7									Y	11/03/2006	11/04/2006	1		PVT	PVT	Synthroid	NONE	NONE			1						1	Dizziness	FLU3~SANOFI PASTEUR~U2255AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268173	12/04/2006	KS	40.0	40		F	11/16/2006	Pt stated swelling in the left supra clavicular ore, a small amount of pain noticed as well, the symptoms lasted five days, no treatment was needed.									Y	11/13/2006	11/14/2006	1		PVT	PVT						1						1	Oedema; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71642~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268174	12/04/2006	CA	60.0	60		M	11/25/2006	My husband  had flu shot, 9 hours later we had severe vomiting and Diarrhea that lasted into the early morning hours.									N	11/22/2006	11/22/2006	0	NONE	PVT	UNK	Zocor.	NONE	Borderline Cholesterol.			1						1	Diarrhoea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0268175	12/04/2006	CA	60.0	59		F	11/25/2006	I had flu shot, 9 hours later I had severe vomiting and diarrhea that lasted into the early morning hours.									N	11/22/2006	11/22/2006	0	NONE	PVT	UNK	Altace, Evista	NONE	High blood pressure.			1						1	Diarrhoea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0268176	12/04/2006	VA	1.73	1	.7	M	11/21/2006	Induration over vaccine site, (site of Dtap and Prevnar on right thigh.									U	11/20/2006	11/21/2006	1	NONE	PVT	OTH	Amoxicillin, Debrox ear drops.	Otitis media on treatment	NONE			1						1	Injection site induration	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC143027AA~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2187AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0278F~4~IM~LL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08649E~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0268177	12/04/2006	SC	57.0	57		F	11/14/2006	Redness, swelling from just above elbow to shoulder. Site was hot to the touch. From injection site to below left ear ached. Lasted approx 3 days for aching, redness, and heat stayed over 10 days.									Y	10/27/2006	10/27/2006	0	NONE	OTH	PVT	Synthroid, Hyzaar	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69897~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268178	12/04/2006	SC	65.0	65		F	11/13/2006	Area around injection was red and itched. Lasted for 4 days. Itching started about 10 min after injection was given.									Y	10/27/2006	10/27/2006	0	NONE	OTH	PVT	Lopressor, Hyzaar, Lasix, Potassium		High Blood pressure.			1						1	Injection site erythema; Injection site hypersensitivity; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69897~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268179	12/04/2006	SC	29.0	29		M	11/13/2006	Red, warm, sore area around the shot. About 4in x 3in.									Y	10/27/2006	10/27/2006	0	NONE	OTH	PVT	Piltiazem, lisinopril.	NONE	Hypertension, Allergic to Ceclor and Hydrocodone.			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69897~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268180	12/04/2006	SC	24.0	23		F	11/13/2006	My arm was red, and puffy where the vaccine was given. My arm itched also.									Y	10/27/2006	10/28/2006	1	NONE	OTH	PVT		NONE	NONE			1						1	Injection site erythema; Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69897~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268181	12/04/2006	SC	47.0	46		F	11/14/2006	Large red area surrounding location of vaccine, swollen, hot to touch, soreness, lasted about 4 days.									Y	10/27/2006	10/27/2006	0	NONE	OTH	PVT						1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69897~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268182	12/04/2006	SC	47.0	46		F	11/12/2006	Swollen, red, hard at injection site on left arm.									Y	11/10/2006	11/11/2006	1	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site oedema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69897~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268183	12/04/2006	SC	58.0	57		F	11/13/2006	Very red 1 diameter hot to touch very sore. Lasted 5-6 days.									Y	10/27/2006	10/28/2006	1	NONE	OTH	PVT		NONE	Hypothyroidism.			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69897~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268184	12/04/2006	SC	61.0	60		F	11/13/2006	Slight itching after injection (shortly after), next day redness and soreness about size of silver dollar. Itching, mild, continued for about 10 days. Redness lasted 5-7 days.									Y	10/30/2006	10/30/2006	0	NONE	OTH	PVT						1						1	Injection site erythema; Injection site hypersensitivity; Injection site pain; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69897~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268185	12/04/2006	SC	54.0	54		F	11/20/2006	Local Swelling 2 diameter local fever, arm sore, ache.										11/14/2006	11/14/2006	0	NONE	OTH	PVT		NONE	NONE			1						1	Injection site oedema; Injection site pain; Injection site warmth; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69897~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268186	12/04/2006	SC	58.0	57		F	11/16/2006	The area around the injection at 1/4 in diameter became sore and hot to touch on 11/14/06 and the same area itched on 11/15/06.									Y	11/13/2006	11/14/2006	1	NONE	OTH	PVT	Evista, Synthroid, Tylenol arthritis, Bayer aspirin, Itraconazol.	NONE	Penicillin.			1						1	Injection site hypersensitivity; Injection site pain; Injection site warmth; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69897~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268187	12/04/2006	IL	2.0	2	.1	M	11/29/2006	No signs of fever, rash, chills HA or muscle aches no bruising or redness to injection site. Influenza 0.5cc given instead of 0.25CC.									Y	11/15/2006	11/29/2006	14	NONE	PVT	PVT	NONE	NONE	Asthma			1						1	Medication error	FLU3~SANOFI PASTEUR~42253AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268188	12/04/2006	IL	56.0	55		F	11/27/2006	Pt noted redness and warmth to injection site day after injection and some swelling ice applied.									Y	10/24/2006	10/25/2006	1		PVT	UNK						1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA213BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268190	12/04/2006	PA	6.0	6		M	12/01/2006	Arm red and itchy.				Y					U	11/29/2006	11/30/2006	1		PVT	PVT						1						1	Injection site erythema; Injection site hypersensitivity; Pruritus	FLU3~SANOFI PASTEUR~V2169MA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268191	12/04/2006	VA	67.0	66		M	11/29/2006	See attached									Y	10/25/2006	10/28/2006	3	NONE	UNK	PUB		NONE	NONE			1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA210AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268192	12/04/2006	CA	4.0	4		M	11/27/2006	Pt inadvertently given MMR 3 instead of Varivax 2, no physical signs symptoms.									Y	11/07/2005				PVT	PUB						1						1	Medication error	FLU3~SANOFI PASTEUR~U2169PA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0254F~UNK~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0268193	12/04/2006	OK	44.0	44		F	11/22/2006	Burning eyes, swelling, difficulty breathing.				Y					Y	11/14/2006				OTH	OTH		NONE				1						1	Dyspnoea; Eye inflammation; Oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0268194	12/04/2006	MI	77.0	76		F	11/02/2006	Began sneezing (near constant) early am day after vaccine received, continued until 10/29/06, gone by evening of 10/29/06. Evening of 10/29/06 onset of dry coughing last 2 days. No other symptoms. Now well with complete resolution of symptoms. no medical provider visit.									Y	10/25/2006	10/26/2006	1		PUB	PUB			Allergic to PCN, taramycin codeine, DM, cardiac stent placed 1999, left ventricle valve leaking.			1						1	Cough; Sneezing	FLU3~SANOFI PASTEUR~U2178AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268195	12/04/2006	TX	51.0	50		F	10/09/2006	Localized reaction on left upper arm sore redness, tenderness, bronchial reaction, constipation, wheezing, resolved with Epi Pen and Albuterol inhalation.									Y	10/06/2006	10/06/2006	0		OTH	PVT						1						1	Constipation; Injection site erythema; Injection site pain; Tenderness; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70735~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268196	12/04/2006	TX	49.0	49		F	11/20/2006	Pt was given flu shot at 15:07 and was asked to wait so after that, after 30 minutes she left and returned approx 15 minutes after and said she was feeling warmness on left arm at chest. BP 200/104. She was monitored for 20 mins and B/P was rechecked and reading 150/102, advised to call her Dr and notify of reaction. She called DR office and office nurse told her to take Benadryl. Pt stated she was feeling better, was also checked by school nurse.									Y	11/15/2006	11/15/2006	0		PUB	PVT		NONE				1						1	Blood pressure increased; Feeling hot	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70735~6~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268197	12/04/2006	CA	2.0	2	.1	M	11/16/2006	Pt had a seizure (generalized) lasting 5-6 minutes occurred less than 24 hours after influenza vaccine administration. First time pt received this vaccine.				Y					Y	11/15/2006	11/16/2006	1	EEG ordered, electrolytes ordered.	PVT	UNK	Albuterol (Neb) Pulmicort	Upper respiratory tract infection	Asthma, History of febrile seizure x 1			1						1	Convulsion	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0268198	12/04/2006	IA	20.0	20		F	11/22/2006	Approx 1 hour after flu vaccine was given her mother noticed her face and neck were swollen although she herself did not notice this. Reports she slept about 3 hours after wards. Denies throat swelling, difficulty swallowing or breathing. Claims swelling was gone after 3 hour nap.									Y	11/10/2006	11/10/2006	0	NONE	PVT	UNK		NONE				1						1	Face oedema; Oedema	FLU3~SANOFI PASTEUR~U2253AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268199	12/04/2006	AL	84.0	84		F	11/07/2006	Received Flu vaccine 11/3/06. Pt states on 11/6/06 around 4:30pm started having left arm pain at chest pain. States she called RN yesterday et was instructed to apply ice to shot site and take Tylenol. States she applied ice et took Aleve. Also took Lusonex for allergies left upper arm, red, swollen and area size of quarter having bruise. Red and swollen left upper approx 4-6 long et 2 wide. Warm to touch.									Y	11/03/2006	11/06/2006	3		PUB	PUB	On BP Meds	Sinus drainage and fever blisters	9/11/06 high blood pressure.		AL0629	1						1	Chest pain; Contusion; Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA215BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268200	12/04/2006	GA	4.0	4		F	12/04/2006	Left thigh red, swollen and itchy site 5in x 4in no abscess, reaction began 24 hours prior to recheck in our office.				Y					Y	12/02/2006	12/03/2006	1	NONE	PVT	PVT	NONE	Sinusitis	NONE			1						1	Injection site erythema; Injection site hypersensitivity; Injection site oedema; Pruritus	FLU3~SANOFI PASTEUR~U2254AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268201	12/04/2006	MO	4.0	3		M	11/29/2006	Local reaction 1cm diameter of warm, erythematous, swelling and blotchy red/white rash below injection site on thigh to knee.				Y					Y	10/24/2006	10/25/2006	1		PVT	OTH	Zantac, Flovent, Singulair, Fluoride. Vitamins					1						1	Injection site erythema; Injection site oedema; Injection site warmth; Rash macular; Skin discolouration	FLU3~SANOFI PASTEUR~U2212AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268202	12/04/2006	AR	4.0	3		F	12/01/2006	Vaccine given in thigh area red and swollen. No pain noted. Pt was seen in our office for visit and no adverse reaction noted.									Y	11/14/2006	11/15/2006	1	NONE	PUB	UNK		NONE	NONE			1						1	Injection site erythema; Injection site oedema	FLUX~UNKNOWN MANUFACTURER~~3~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0268203	12/04/2006	IN	42.0	42		M		Left acute brachial plexus neuritis, evaluated by neurologist.   12/14/06 Received medical records from neurologist which reveal patient eval showed decreased strength & grip in left arm/hand.  Tx w/steroids & pain meds & scheduled for EMG on 12/4.  No EMG report included.  T/C to neuro office to request EMG report.				Y					U	10/28/2006	11/07/2006	10	EMG scheduled for 12/04/06 12/14/06 Received EMG report which reveals abnormal study showing acute & ongoing C7-8 radiculopathy or lower brachial plexopathy.	PUB	OTH	NONE	NONE	NONE			1						1		FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268204	12/04/2006	WI	29.0	28		M	12/04/2006	Erythema and soreness left arm.									Y	11/29/2006	12/02/2006	3	NONE	OTH	OTH	Lantus insulin, Nova insulin		Diabetic I			1						1	Injection site erythema; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72000~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0620F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268205	12/04/2006	MO	63.0	63		F	12/04/2006	Deep, aching pain in upper right arm and shoulder developed on 10/30/2006. I took Naproxen and TRAMADOL.  I reported this to PCP through fax and telephone message.  I saw PA name reported on 11/4/2006.  She prescribed Ibuprofen and Lido Derm Patches and ordered blood work.  These medications did not help.  PA name reported prescribed MEDROL Pak after blood work results and ordered referral to neurologist.  MEDROL Pak gave me TY-relief only, after 6 days of use pain became acute, I am now using 2nd Dose Pak and seeing neurologist on 12/07. I am unable to lift anything with this arm.  I feel severe pain when I move this arm or while I am in bed.  12/14/06 Received medical records from provider which reveal patient seen 10/28/06 with dyspnea & + TB skin test, gastritis, DJD, carpal tunnel & high cholesterol.  Records included Lot numbers missing from report.  Next seen on 11/4/06 with pain on palpation over right shoulder, no swelling or redness noted but ROM & grip strength of right arm/hand was decreased.  Referred to neuro & given steroids to start after labs done. 1/16/07 Received records from neurologist which reveal patient seen 12/7/06 for pain of right shoulder & arm subsequent to tetanus vax 10/28/06.  Neuro exam was WNL with some mild difficulty raising arm above head.  It was felt that the problem was frozen shoulder or adhesive capsulitis due to the pain rather than any true muscle or nerve involvement.  She was referred for intensive PT to be continued for 4-6 weeks then was to return for further evaluation.				Y					N	10/28/2006	10/30/2006	2	blood work result (to be provided by doctor's office, doctor's office has been requested). LABS: CRP elevated at 28.34, WBC 8.0.  Elevated triglycerides, cholesterol & A1C Hgb.  CXR was WNL.	PVT	UNK		NONE	NONE PMH: dyspnea, +TB skine test, gastritis, DJD, carpal tunnel, hypercholesterolemia			1						1	Joint range of motion decreased; Pain; Shoulder pain	FLU3~AVENTIS PASTEUR~V71642~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~AVENTIS PASTEUR~U1847BA~UNK~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0268216	12/04/2006	MA	35.0	35		F	11/20/2006	Received flu shot 11/17/06 in office-started within 20 min. Elbow down to 1st and 2nd fingers. Pain and very weak could still bend fingertips, couldn't lift a plate). No numbness. Self limiting resolved in 15 minutes-held arm above heart and kept moving.									Y	11/17/2006	11/17/2006	0		PUB	UNK		None	None			1						1	Joint range of motion decreased; Muscular weakness; Pain	FLU3~SANOFI PASTEUR~U2215AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268218	12/04/2006	NJ	39.0	39		M	12/04/2006	Patient describes soreness to right deltoid area after receiving flu vaccine on 11/3/06. Patient describes whole arm sore. Examined by MD on 12/1/06. DX- rt shoulder pain following flu vaccine. Tx- continue NDAIDS. F/u in 1 month if pain continues.										11/03/2006	11/03/2006	0		UNK	UNK						1						1	Pain; Shoulder pain	FLU3~SANOFI PASTEUR~U2197AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268219	12/04/2006	DE	0.83	0	.8	M	12/04/2006	Significant swelling and purple discoloration of distal left lower extremity with moderate swelling of distal right lower extremity and b/l distal upper extremities.				Y					Y	12/01/2006	12/01/2006	0	none	UNK	UNK	pulmicort, zantac, prilosec, albuterol	none	gastroesophageal reflux disease, laryngomalacia, feeding disorder, poor weight gain			1						1	Skin discolouration; Swelling	FLU3~SANOFI PASTEUR~U2254AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268221	12/04/2006	VA	54.0	54		F	12/04/2006	Pt c/o arm soreness that travels down the arm continuing for time following vaccine. Worsenes over time.									U	11/20/2006	11/20/2006	0		UNK	UNK	Neurontin	None	Headaches Peanut allergies			1						1	Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0268225	12/04/2006	WA	33.0	32		M	12/04/2006	Pt reported significant respiratory distress that awakened him from sleep 8-10 hours after getting his flu shot.  He describes his symptoms as similar to past asthma attacks with wheezing, but had an unusual sensation of chest tightness  ...almost like someone was standing on my chest.  Used albuterol inhaler - 2 puffs - and felt his symptoms improved enough to return to sleep.  Upon awakening in the morning, he had some remaining chest tightness and he was fatigued from disturbed sleep. He also minor body aches that improved.  + hx of childhood asthma that now is related to seasonal allergies, worse in spring.  Received allergy shots for 3 years, now on monthly maintenance.  Takes no meds except vitamin, fexofenadine prn for seasonal allergies, and albuterol inhaler prn.  Denies current allergy or asthma symptoms, hx of heart disease or a reaction to past immunizations of any kind. Does not get a flu shot every year, but has never had a reaction of any kind in the past.									Y	10/30/2006	10/30/2006	0	None, pt did not seek medical attention.	UNK	UNK	multivitamin qd, fexofenadine prn,albuterol inhaler, 1 or 2 puffs as needed.	none. Denies feeling ill, egg allergy or previous reaction to flu vaccine.	allergies asthma minor arthritis			1						1	Asthma; Chest discomfort; Fatigue; Pain; Respiratory distress; Sleep disorder; Wheezing	FLU3~SANOFI PASTEUR~Y2240AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268226	12/04/2006	WA	45.0	46		F	12/04/2006	Tdap given IM left deltoid (non-dominant arm) on 11/29/06. On 12/3/06 pt noticed sore arm at injection site, tender left armpit. URI symptoms also present w/acute bronchitis and sinusitis diagnosed. For injection site discomfort recommended Tylenol. Given abx, steroid inhaler and beta-2 agonist inhaler for bronchitis in a smoker with pending dental work.  Influenza shot given IM right deltoid without any discomfort. URI symptoms as noted above.									U	11/29/2006	12/03/2006	4	none	UNK	UNK	Synthroid, fish oil (OTC)	none	hypothyroidism w/thyromegaly secondary to thyroiditis; hyperlipidemia, impaired fasting glucose, tobacco smoking, overweight, pruritis ani			1						1	Bronchitis; Injection site pain; Sinusitis; Upper respiratory tract infection	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72222~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C263BAA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0268227	12/04/2006	CT	54.0	54		M	12/04/2006	11/30/06 Called PDDH to report he started at noon today feeling nauseated, dizzy.  No fever. Sx came on suddenly. Instructed to call MD.									U	11/29/2006	11/30/2006	1		UNK	UNK		None				1						1	Dizziness; Nausea	FLU3~SANOFI PASTEUR~U2260AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268228	12/04/2006	TX	33.0	33		F	12/04/2006	Vaccine injected into left deltoid on Wednesday 11-29-06 @ 8:30 am.  During and immediately after injection, she said she felt it run down her arm to fingertips.  It felt tingly and numb.  She was told to move her fingers and let me know if she felt short of breath or had any chest pains, etc. On 11-30-06 she felt a small knot (nickel size) approx 1-2 inches under injection site.  It felt hard but was not red or sore.  Then on Monday 12-4-06, she said that her left fingers were still tingly and numb.  Not all the time but off and on every day since 11/29.									N	11/29/2006	11/29/2006	0	None yet	UNK	UNK	Diovan -High blood pressure Celexa - Anti-depressant Sesasonle-BC     Zyrtec	None	High blood pressure Allergic to cats			1						1	Hypoaesthesia; Injection site induration; Injection site mass; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70735~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268229	12/04/2006	TX	33.0	33		F	12/04/2006	11:30 am single injection in right deltoid 3:30 pm patient's voice begins to get hoarse 4:30 pm patient completely loses voice and feel throat start to swell 5:00 pm arrive at ER, no voice and throat very swolen, patient is light headed and having difficulty breathing 5:30 pm Adreniliane is administered as single injection, Antihistimine is given via IV and breathing treatment of albutorol (or equivalent) given at hospital.  X-ray taken of throat 6:00 pm Patient starts to get voice back and swelling starts to go down. 7:30 pm Patient discharged from ER and given Rx for Steroids, antihistamine and anti-anxiety.				Y					Y	11/30/2006	11/30/2006	0	Accute laryngeal edema due to flu shot	UNK	UNK	Zoloft, Tri-ness tablets - 28's	No	Allergic to botox, dust mites, tree pollen			1						1	Dizziness; Dysphonia; Dyspnoea; Laryngeal oedema; Pharyngeal oedema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70735~1~SC~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0268230	12/04/2006	MO	22.0	22		M	12/04/2006	Guillaine Barre Syndrome 12/21/06-records received and reviewed from reporter. GBS-with ascending peripheral hyposensation. CXR revealed pulmonary edema. Transferred to hospital.  01/16/07-records received and reviewed for DOS 12/3-12/14/06 DC DX: GBS- trach for pneumonia, transferred to ECF for rehab. numbness began in feet then tingling in hands extending to knee and elbows. Difficulty keeping right eye opened and difficultly swallowing. On 12/3/06 ataxic gait.  Decreased grip and strength in lower extremities.  Annual follow up information indications status of recipent recovery still unknown. Recipient of the letter is no longer stationd in the same area with this soldier.			Y	Y	Y	10	Y		U	10/30/2006	12/03/2006	34	WBC 8.9, CT negative. CSF: RBC 28. Concentrated cytospins demonstrate mononuclear leukocytes. Protein 21, glucose 54. culture negative. pre albumin 10.6, albumin 51.7, Alpha 1 G 5.6, Alpha 2 G 937, Beta G 16.1, Gamma G 6.4 All cultures negative.WBC ranged from 8.7-18.6	MIL	MIL	pcn vk 250 bid	none	none			1						1	Guillain-Barre syndrome	FLUN3~MEDIMMUNE VACCINES, INC.~500428P~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHAVB068BB~UNK~~~HEP A + HEP B (TWINRIX)~1|IPV~SANOFI PASTEUR~y10302~UNK~~~POLIO VIRUS, INACT. (IPOL)~1|MEN~SANOFI PASTEUR~UE514AA~UNK~~~MENINGOCOCCAL (MENOMUNE)~1|MMR~MERCK & CO. INC.~0730R~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|TDAP~SANOFI PASTEUR~c25272aa~UNK~~~TDAP (ADACEL)~1	USA	Life Threatening,Hospitalisation	Influenza
0268231	12/04/2006	AR	37.0	36		M	12/04/2006	Within 24 hours of injection had fairly intense headache lasting about 36 hours. Associated with Nausea. No vomiting. Unresponsive to Motrin 800mg taken three times during course of headache.									Y	11/28/2006	11/29/2006	1	None	UNK	UNK						1						1	Headache; Nausea	FLU3~SANOFI PASTEUR~u2308aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268248	12/04/2006	MI	32.0	32		M	12/04/2006	This case was reported by a healthcare professional and described the occurrence of respiratory infection in a 32-year-old male subject who was vaccinated with Influenza virus vaccine trivalent (FluLaval) for prophylaxis.  The subject had no pre-existing medical conditions.  The subject had received influenza virus vaccine in previous years with no subsequent adverse events. Concurrent medications included Glycopyrronium bromide (Robinul), Fexofenadine hydrochloride (Allegra), Atenolol (Tenormin), Calcium carbonate (Oscal), Eflornithine (Vaniqa) and Risefronic acid (Actonel).  On 15 November 2006 the subject received a dose of FluLaval.  The reporting healthcare professional follow-up with the subject approximately one week later and the subject had  no side effects to report.   On 26 November 2006, 11 days after vaccination with FluLaval, the subject experienced a fever of 102 degrees Fahrenheit and a respiratory infection.  On 28 November 2006 the subject was taken to the emergency room.  The healthcare professional reported that on 28 November 2006 the subject had stopped breathing and they (the emergency room) were unable to resuscitate.  The subject died on 28 November 2006.  It was unknown whether an autopsy was performed.	Y			Y					N	11/15/2006	11/26/2006	11	body temperature 26Nov2006 102 Fahrenheit	PUB	PUB	Glycopyronium bromide, Fexofenadine hydrochloride, Atenolol, Calcium carbonate, Efloraithine, Risedronic acid				A0630100A	1						1	Apnoea; Pyrexia; Respiratory tract infection	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2S601211~UNK~~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Results in Death	Influenza
0268258	12/04/2006	LA	1.0	1	.0	M	12/04/2006	Swelling to eyes and lips and wheezing. He received Albuterol Neb treatment x 2, IV Benadryl and IV Solumedrol. Admitted for 23 hours observation.  1/16/07 Received medical records from hospital which reveal patient admitted 11/30/06 angioneurotic edema, SOB & wheezing following vax.  Treated w/nebs, IV Benadryl & steroids w/improvement.  Admitted for 23 hour observation. FINAL DX: anaphylactic reaction s/p immunizations.					Y	1			Y	11/30/2006	11/30/2006	0		PUB	PUB	J-tan 2ml  twice a day		Hemangioma, HX of hypoxia at birth, SGA, Term baby.  PMH: neonatal seizure			1						1	Eye swelling; Swelling face; Wheezing	FLU3~SANOFI PASTEUR~U2174KA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0560R~1~IM~RL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~1132R~1~SC~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08649H~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0268259	12/04/2006	AZ	80.0			M	12/04/2006	One Week of URI symptoms presented to hospital 10/20 S/P fall and difficulty walking. He had respiratory failure and required intubation 10/21, Plasma pheresis and IVIG.  12/29/06 Received medical records from hospital which reveal patient admitted 10/30/06-11/6/06 for severe weakness & respiratory distress.  Patient had been transferred from outlying hospital where he presented on 10/20 s/p fall & difficulty walking one day prior.  Had symptoms of URI for approx 1 week prior & was being treated w/oral antibiotics.  Diagnosis was initially made at outlying hospital & patient received plasmapheresis x 5 cycles, last on 10/26, & was placed on ventilator.  LP done at outlying hospital.  Neuro, cardio & critical care consults done at second hospital.  Patient received IVIG  Received trach & PEG feeding tube.  Transferred to skilled nursing facility still on vent & antibiotics. FINAL DX: Guillain Barre Syndrome; respiratory failure; & pneumonia.			Y		Y	19					10/20/2004		LABS: CT of chest revealed bilateral infiltrates & effusions.  CT of head was WNL. CSF protein reported in notes as being 50.  Endotracheal aspirate culture grew Enterobacter.  WBC 21,000	OTH	OTH			HTN, GERD, BPH, Prostate CA, COPD.  PMH: diverticulosis & hemorrhoids.  S/P cataract extraction, radical prostatectomy & hemorrhoidectomy.			1						1	Difficulty in walking; Fall; Hypoxia; Respiratory failure; Upper respiratory tract infection	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0268260	12/04/2006	CA	0.94	0	.9	F	12/04/2006	Three days later, Pt heavy loose stool, Diarrhea, low grade temp. Treated for diarrhea.				Y					N	11/29/2006	12/02/2006	3		PVT	PUB		Low grade temp				1						1	Diarrhoea; Pyrexia	FLU3~SANOFI PASTEUR~UT2191JA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268261	12/04/2006	CA	0.75	0	.8	F	12/04/2006	Two days later, patient having loose stools-(diarrhea). Treating diarrhea.				Y					Y	12/01/2006				PVT	PUB	Routine meds	crying-fussy	No known drug allergies, prematurity			1						1	Diarrhoea	FLU3~SANOFI PASTEUR~UT2191JA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268262	12/04/2006	CA	0.88	0	.9	M	12/04/2006	Patient having low grade temp next day. Two days later, heavy diarrhea and temp. Treating diarrhea.				Y					N	12/01/2006	12/03/2006	2	stool culture-pending	PVT	PUB	routine meds	low grade temp	allergy possibly to milk, pulmonary hypertension			1						1	Diarrhoea; Pyrexia	FLU3~SANOFI PASTEUR~UT2191JA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268263	12/04/2006	CA	3.0	2	.9	M	12/04/2006	Patient having fever, next day then two days later having diarrhea.				Y					N	11/29/2006	12/01/2006	2		PVT	PUB	routine meds	low grade temp-shows later	No known drug allergies, History of hypoxic encehalopath			1						1	Diarrhoea; Pyrexia	FLU3~SANOFI PASTEUR~U2187AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268264	12/04/2006	FL	2.0	2	.4	F	12/04/2006	Flu vaccine given around 5pm on 12/1/06. Mom did not notice problem until Sat morning. Child had hives on arms, legs, and trunk taken to ER. Nothing given. Called Doctor. No reaction at injection site. Received the vaccine last year 2 doses.				Y					Y	12/01/2006	12/02/2006	1	None	PUB	UNK		None				1						1	Urticaria	FLU3~SANOFI PASTEUR~U21751A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0256938	12/05/2006	NE	1.24	1	.2	M	12/01/2006	Information has been received from a physician concerning a 15 month hold white male infant who on 11 Nov 2005 was vaccinated intramuscularly into the right thigh with the third dose of hepatitis B virus vaccine rHBsAg. At that time, the patient was vaccinated subcutaneously into the thigh with the first dose of varicella virus vaccine live and intramuscularly into the left thigh with the second dose of influenza virus vaccine. The patient had no illness at the time of vaccination.  On 14 Nov 2005, the patient was noted to cry when tries to bear weight on right leg, won't crawl or walk and had developed a fever 102. On 16 Nov 2005, the patient was seen in the office. The patient had laboratory work obtained that revealed an elevated erythrocyte sedimentation rate notes as 45 mm/h. At that time, laboratory data was noted to include white blood cell count 5.51 thousand, blood monocyte count 14.7% and serum C-reactive protein test <0.3 mg/dL. The patient sought unspecified medical attention. The patient was recommended to take ibuprofen and use warm compresses. On 18 Nove 2005, the patient recovered from the events.  Additional information is not expected.				Y					Y	11/11/2005	11/14/2005	3	monocyte count 11/16/2005 14.7% body temp  11/14/06  102 erythrocyte 11/16/05 45mm/h serum C-reactive protein 11/16/05 <0.3 mg/dL WBC count 11/16/05 5.51 thous	PVT	PVT	Unk		Unk		WAES0512USA03907	1						2	Laboratory test abnormal; Pain; Pyrexia; Rash erythematous; Difficulty in walking; Pyrexia; Red blood cell sedimentation rate increased; Vaccination complication	FLU3~SANOFI PASTEUR~U1787CA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~6524980643R~3~IM~RL~HIB + HEP B (COMVAX)~1|VARCEL~MERCK & CO. INC.~6466690626R~1~SC~RL~VARICELLA (VARIVAX)~1|FLU3~SANOFI PASTEUR~U17871A~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|HBHEPB~MERCK & CO. INC.~652498/0643R~3~IM~~HIB + HEP B (COMVAX)~2|VARCEL~MERCK & CO. INC.~646669/0626R~1~SC~~VARICELLA (VARIVAX)~2	USA	Emergency room visit	Influenza
0266205	12/05/2006	TX	1.09	1	.1	M	11/20/2006	Seizure related to increase temperature-EMS was called by parents				Y					N	11/02/2006	11/02/2006	0		PVT	PVT		None				1						2	Pyrexia; Respiratory failure; White blood cell count increased; Body temperature increased; Convulsion	FLU3~SANOFI PASTEUR~U2196AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~UNKNOWN MANUFACTURER~C0806~3~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0950F~1~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|FLU3~SANOFI PASTEUR~U2196AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|IPV~SANOFI PASTEUR~Z0306~3~SC~RL~POLIO VIRUS, INACT. (IPOL)~2|MMR~MERCK & CO. INC.~0950F~1~SC~LL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~2|PNC~PFIZER\WYETH~B08646B~4~IM~RL~PNEUMO (PREVNAR)~2	USA	Emergency room visit	Influenza
0268257	12/05/2006	IL	75.0	74		F	12/04/2006	Severe pain on injection site 6 weeks after flu shot.									N	10/17/2006	10/18/2006	1	X ray showed no abnormality.	OTH	OTH	NONE	NONE	NONE			1						1	Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA211BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268267	12/05/2006	NH	3.0	3		F	12/04/2006	11-18-06 child developed red spots on face and hands 6 hrs after getting flu shot. Face rash has calmed down, blanches was itchy. Temp 95.1. Eating and drinking ok. Mother called our office after hours. Advised to monitor. Give baking soda or oatmeal baths, may try Benadryl 10 mg every 6 hours Prn.									Y	11/18/2006	11/18/2006	0	Mother requested patient to be tested for allergies.	PVT	PUB			Reflux gastroesphoegael-resolving, reactive airway disease, urticaria			1						1	Injection site discolouration; Rash	FLU3~SANOFI PASTEUR~U2167UA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268270	12/05/2006	VA	7.0	7		F	11/23/2006	(OMIC). A report was received from a physician of seizure coincident with FluMist. A seven year old female with a history of febrile seizures, received FluMist on 9/14/06. The next day she developed a low grade fever and later had an episode of seizure. The events happened while the pt was on vacation with her family. The reporter was notified of the events one week later. According to the reporter, the pts mother called their office to notify them of the event one week after it occurred. The pt was seen by a relative pediatrician who was with them at the time. No treatment was reported. The pt is not taking any anti convulsant medications. The reporter also noted that in the past, the pts mother reported episodes of seizure even with just a low grade fever. The pt recovered from the seizure on 9/15/06 and recovered from the low grade fever on an unreported date. No further episodes of seizure was reported. The reporter also added that the pt received the varicella live vaccine Varivax on the same day that she got FluMist. She also said that in 2004, the pt received FluMist without any reported adverse event. The reporter causality was not provided.									Y	09/14/2006	09/15/2006	1		PVT	OTH	Concomitant Drug (s) Not Used		Febrile Seizure		MEDI0005155	1						1	Convulsion; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500429P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~1024r~UNK~IM~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0268290	12/05/2006	MA	36.0	36		F	11/14/2006	3 hours after injection onset of wheeze, tachycardia 130 dyspnea 911 called, ER eval sx improved without treatment. Waxing waning course. PCP eval next day, EKG, LE Duplex neg. Persistent SX day x 2-3 led to repeat ER eval. Positive D Dimer led to spinal CT. Persistent tachycardia x 3-4 days with exertional dyspnea. Gradual resolution over 12-13 days.  MR received revealing a patient who developed wheezing and the sensation of palpitations and difficulty in breathing, the evening of her flu vax. Pt was brought via ambulance to ER where she began to have chest pressure and nausea. Evaluation was GERD and she was released.  Chest pain occured again the following day and she was evaluated in the office and then sent to another ER where she was admitted. PE: WNL except for a 1-2/6 short systolic ejection murmur along the left sternal border.  Symptoms of chest pressure and tachycardia seem to be related to activity and eating. Improvement noted when leaning forward or lying on left side. Assessment: Chest tightness-unclear etiology (?reactive airway spasm or pericarditis).  Tachycardia of unknown etiology.  PCP MR received with ER notes from first ER visit included. ER visit as noted above. Labs and Diagnostics: all negative. DX:? mild allergic reaction to flu vaccine, ? GERD. F/U visit to PCP on 11/14/2006 where pt. states resolution to chest pain except for occasional transient discomfort with exertion.					Y	3			Y	11/01/2006	11/01/2006	0	Labs and Diagnostics: Venous duplexes-normal bilaterally, CXR (-), Spiral CT-no evidence for PE, D-dimer negative, cardiac enzymes (-) X3.others WNL.  EKGs have been normal to Sinus tachycardia with minor non-specific ST-T changes. 2D echo WNL except trace mitral regurgitaion. Dobutamine Stress test-chest pain during stage 1 and throughout exercise and innappropriate BP increase noted.  Stress test (-) for ischemia.	PVT	OTH	Synthyroid 125mg PO everyday. Meds: Albuterol, Flovent, Prilosec, Zithromax, Protonix, Synthroid and prednisone.	Mild respiratory illness, cold.	Asthma mild intermittent, sulfa allergy.  PMH: hypothyroidism, asthma, and chronic back pain.  Allergies: sulfa.			1						1	Dyspnoea; Tachycardia; Wheezing	FLU3~SANOFI PASTEUR~U2204AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0268291	12/05/2006	MO	11.0	11		M	11/27/2006	24 hours after injection developed diffuse cellulitis around injection site of pneumococcal. Clarification from vaccine provider.  Reaction was in left arm (Pneumovax and Adacel). MR reveals an 11 yr old who developed fever and  rash on his Left arm at the site of his Pneumovax and Adecel vax.  HPI: Child woke with pain in both arms the night after vax. and c/o fever.  Mom noticed a rectangular rash at the site of vax. on the left arm.  Seen by PMD and treated with Keflex without improvement.  Fever continued to rise and erythema and pain continued and spread.  ER visit 2 days after vax.   PE showed a 4x5 cm area of erythema, warmth, and tenderness to palpation of the left upper arm.  The patient was febrile.  He was admitted for treatment with IV antibiotics.  Pt. was treated with IV Clindamycin and Vancomycin and released to home after 4 days in stable condition to continue po Clindamycin x 7 days. Discharge DX:  Left arm cellulitis.					Y	4			Y	11/06/2006	11/07/2006	1	CBC, ESR increased, BC neg. Labs and Diagnostics:  WBCs 32.8 on admission. Sed rate 24, CRP 51.8.  Ultrasound showed soft tissue swelling.  WBCs dropped to 21.4 2 days later. Sed rate increased to 40, CRP increased to 90.4.	PVT	PUB	NONE Meds: Albuterol MDI.		RAD mild intermittent PMH: mild, intermittant reactive airway disease.  NKDA			1						1	Cellulitis; Injection site reaction; Red blood cell sedimentation rate increased	FLU3~SANOFI PASTEUR~U2286AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHABV130AA~2~IM~RA~HEP A (HAVRIX)~1|PPV~MERCK & CO. INC.~1006P~1~IJ~LA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C23357AA~1~~LA~TDAP (ADACEL)~1	USA	Hospitalisation	Influenza
0268293	12/05/2006	CO	11.0	10		M	11/21/2006	Wrong vaccine given for age on 11-18-06 at approx 10am. No adverse event noted.									Y	11/18/2006			None	PUB	PUB	None	None noted	None noted			1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601711~1~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268294	12/05/2006	CO	4.0	4		M	11/28/2006	None noted. Received 18 and up vaccine Flulaval instead of Fluzone.									Y	11/18/2006			None	PUB	UNK	None	None	None			1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601711~1~~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0268295	12/05/2006	CO	22.0	22		F	11/28/2006	None noted-did not disclose that she was pregnant at the time of screening. Given Flumist then told she was pregnant 2 months.									Y	11/18/2006				PUB	PUB	None	None	Pregnant 2 months			1						1	Vaccination complication	FLUN3~MEDIMMUNE VACCINES, INC.~500429P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0268296	12/05/2006	CO	11.0	11		F	11/21/2006	Wrong vaccine given for age on 11/18/06 at approx 0915. No adverse even noted.									Y	11/18/2006			None	PUB	PUB	None					1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601711~1~~~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0268297	12/05/2006	TX	68.0	68		F	12/04/2006	Swelling to Left mid forearm to area just above elbow; redness and warm to touch. Client received flu and Pneumovax on 11/15/06. Visit to physician made for treatment of symptoms and received oral antibiotics-per client report.				Y					U	11/15/2006			None	PUB	PVT	Unk	None specified	No known drug allergies, no medical conditions specified			1						1	Erythema; Feeling hot; Swelling	FLU3~SANOFI PASTEUR~U2239AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0880F~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0268299	12/05/2006	VA	12.0	12		F	12/02/2006	Syncope times 2. MR received for ER visit for syncope x2 one day after flu, Menactra (verified), and Tdap vax.  PMH: 12 yr. with ADD.  PE WNL.   HPI: Child fainted morning after vax. while going to the BR, then fainted again on her way to tell mom.  Taken by ambulance to hosp.  Assessment: Vasogenic syncope, dehydration, muscular disorder				Y					Y	11/06/2006	11/07/2006	1	Labs and Diagnostics: CBC, Chem 16, UA, CXR all WNL.  Head CT (-).  EKG normal with sinus tach. IV fluids	PVT	UNK	Meds: Concerta.	None	Low tone in lower extremities, ADD. Allergies:  Ceclor, cephalosporins.			1						1	Computerised tomogram head; Dehydration; Electrocardiogram abnormal; Full blood count normal; Laboratory test normal; Muscle disorder; Sinus tachycardia; Syncope; Urine analysis normal	FLU3~SANOFI PASTEUR~U2248AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1922AB~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2609AA~1~IM~LA~TDAP (ADACEL)~1|TTOX~SANOFI PASTEUR~C2609AA~1~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0268301	12/05/2006	AK	24.0	24		F	11/02/2006	Throat began tightening up. Used Albuterol and was given Benadryl and oxygen.				Y					Y	11/02/2006	11/02/2006	0		MIL	MIL			allergy to Levaquin and soy		AK200670	1						1	Throat tightness	FLU3~SANOFI PASTEUR~U2199AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268302	12/05/2006	MA	25.0	24		F	11/14/2006	Shortness of breath, wheezing 4 hours after vaccination. IV-Solumedrol, Benadryl				Y					Y	11/14/2006	11/14/2006	0	Unk	PVT	OTH	None	shortness of breath	asthma, previous anaphylaxis to allergy testing			1						1	Dyspnoea; Wheezing	FLU3~SANOFI PASTEUR~U2197AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268304	12/05/2006	MA	10.0	10		M		Child had flu shot 10/24/06 and became ill with viral syndrome 10/30 and ear pain on 11/2 and bell's palsy on 11/4/06.  MR received documenting multiple office visits and several ER visits for a 10 yr old boy who developed constipation, abdominal pain and vomiting 1 week s/p flu vax.  This progressed to right sided ear/jaw pain, facial numbness, and asymmetry. 3 weeks s/p vax. he developed pounding headaches and ultimately periodic loss of vision.  Was out of school x 4 weeks. DX: Viral syndrome, Bells Palsy.										10/24/2006	10/30/2006	6	Labs and Diagnostics: Lymes serology, ESR, EBV all negative.  Abdominal CT negative, Brain MRI unremarkable.	PVT	PUB	Alb, Loraditine, Nasonex, Qvac, Singulair Meds: Albuterol MDI, Loratadine + pseudoephedrine, Motrin, Nasonex, Pepcid, Qvar MDI, Singulair, Amoxicillin, Acyclovir.	None	None PMH: asthma, allergies  Allergies: Shaws Baby Lotion, and environmental.			1						1	Abdominal pain; Blindness; Constipation; Ear pain; Facial palsy; Headache; Hypoaesthesia; Viral infection; Vomiting	FLU3~SANOFI PASTEUR~U2178AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268305	12/05/2006	NY	2.0	2	.4	F	11/28/2006	Redness, swelling and pain at injection site reported 1 day after injection given. These symptoms were in L arm only.									Y	11/08/2006	11/09/2006	1	None	OTH	OTH	None	None	No known allergies			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601311~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0899F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268306	12/05/2006	SC	14.0	14		F	11/21/2006	During mass flu clinic for adults and children an unspecified person gave Fluarix to a child meant for adults 18 year old and older by mistake. No known adverse events. No adverse events occured.									Y	11/17/2006				PUB	UNK	Unk	Unk	Unk			1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA242AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268307	12/05/2006	PA	47.0			F	11/29/2006	Half hour after vaccination experienced visual distribution, neck discomfort, blurred vision, shortness of breath, dyspnea, clammy skin. Discharge ok. Diagnosis: Vasovagal, ER visit. Rest, hydrate. Follow up with facility.				Y					Y	10/27/2006	10/27/2006	0		PVT	OTH		None	History-Asthma			1						1	Cold sweat; Dyspnoea; Musculoskeletal stiffness; Syncope vasovagal; Vision blurred; Visual disturbance	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA205AA~1~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0268308	12/05/2006	PA	39.0	39		F	11/09/2006	Itchy rash 1/2 hour after vaccination with Flushot. Discharged from service. Benadryl  and Prednisone 10mg. Diagnosis-allergic to flu.									Y	10/23/2006	10/23/2006	0		PVT	OTH		None	None			1						1	Hypersensitivity; Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA205AA~1~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268309	12/05/2006	OR	1.27	1	.3	M	11/17/2006	11/17/06 5pm None. Toddler given adult dose of Fluarix mistakingly given as pediatric vaccine.									Y	11/16/2006				PUB	UNK	None	None	None			1						1	Incorrect dose administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFuuA240BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268310	12/05/2006	WI	1.91	1	.9	F	11/27/2006	48 hours after receiving Flu shot and Hep A vaccine high fever and seizure occurred. Taken by ambulance to Red Cedar Medical Center. Follow up needed.  MR received detailing an ER visit of a healthy almost 2 year old who appeared to have a generalized seizure which lasted about 2 minutes, 2 days s/p flu and Hep A vax.. Brought in by ambulance with a temp. of 103.4'F rectally. PE was normal although child was subdued possibly due to being post-ictal.  F/U one week later shows no further problems. Assessment:  Febrile Seizure.				Y					N	11/21/2006	11/23/2006	2	LABS and Diagnostics:  CBC unremarkable, CXR with no acute processes.	PUB	PUB		None	None			1						1	Convulsion; Febrile convulsion; Pyrexia	DT~SANOFI PASTEUR~~UNK~~~DT ADSORBED (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~LL~HEP A (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0268311	12/05/2006	WI	9.0	9		F	11/28/2006	Mom describes baseball size area on Left arm at site of Varivax injection. Red and warm. Ice and Advil per doctor. Seen 11/16/06 in Urgent Care.  Prescribed Keflex 500mg cap every 10hours for 10days.				Y					Y	11/24/2006	11/24/2006	0	None	PVT	OTH	Zyrtec, Miralax	None	Allergic rhinitis, constipation			1						1	Erythema; Feeling hot; Injection site reaction	FLU3~SANOFI PASTEUR~U2201BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1052F~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0268312	12/05/2006	TX	12.0	12		M	11/29/2006	6-8cm mass on left deltoid. Red area around injection site. Slightly pruiritic. Treatment: Claritin 10mg, Prednisone 90mg by mouth every day for 3 days.									Y	11/27/2006	11/29/2006	2	None	PVT	PVT	None	None	None			1						1	Injection site erythema; Rash pruritic	FLU3~SANOFI PASTEUR~U2262AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1065F~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0268314	12/05/2006	OH	46.0	46		F	12/01/2006	11-30-06 PM patient developed diarrhea then later that evening nausea. No vomiting. Today 12/1/06 still has same symptoms but improving did not seek medical attention.									Y	11/29/2006			None	PUB	OTH	Pro-Amitine, estrogen patch-Vivelle	Unk	allergic to Penicillin, Nitroglycerine			1						1	Diarrhoea; Nausea	FLUN3~MEDIMMUNE VACCINES, INC.~500441P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB118AA~1~IM~RA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~Z0324-2~UNK~SC~RA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0268315	12/05/2006	FL	10.0	9		F	11/30/2006	Local edema, hematoma and reactive axillary adenopthy in 4 palpable pea size nodes. Slight tender, possible allergic reaction may need antibiotics (Duricif) if increase in tenderness or swelling.				Y					Y	11/29/2006	11/29/2006	0		PVT	PVT		None	None			1						1	Haematoma; Lymphadenopathy; Oedema; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U2248AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268316	12/05/2006	SC	5.0	5		M	11/21/2006	Vaccine administrator gave wrong drug to a child that was meant for adults -18 year olds and older by mistake. No known adverse event.  No adverse events occured. 3-28-07.									Y	11/17/2006				PUB	UNK	Unk	Unk	Unk			1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA242AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268317	12/05/2006	SC	10.0	10		M	11/21/2006	During mass flu clinic for adults and children a vaccine administrator by mistake gave a child Fluarix which is meant for adults 18 and over.  No known adverse events.  No adverse events occured. 3-28-07.									Y	11/17/2006				PUB	UNK	Unk	None	Unk			1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA242AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268318	12/05/2006	PA	85.0	84		M	11/29/2006	Patient reported fever of 102.0 24 hours after flu shot.									Y	11/15/2006	11/16/2006	1		PVT	UNK		NONE				1						1	Pyrexia	FLU3~SANOFI PASTEUR~U2197AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268320	12/05/2006	MO	0.99	0	1	M	11/28/2006	104 degree temperature. Seizure 12:45 am 11/28/06. Mother stated no treatment. 12/19/06-records received and reviewed. Consultation report  Impression: Febrile seizure. On arrival to ED temp 104.9. After Motrin temp 100.8 CXR: mild peribronchial thickening suggestive of viral bronchiloitis				Y					Y	11/27/2006	11/28/2006	1	None	PUB	PUB		None	None			1						1	Body temperature increased; Bronchiolitis; Convulsion	FLU3~SANOFI PASTEUR~UT219JA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268321	12/05/2006	CA	46.0	46		F	10/30/2006	Frozen shoulder requiring physical therapy and anti inflammatory medication.  Remains under treatment.				Y					U	10/27/2006				PUB	PVT			Lupus			1						1	Shoulder pain	FLU3~SANOFI PASTEUR~U2240AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268322	12/05/2006	MT	60.0	59		M	11/16/2006	Two days after injection, experienced muscle pain in localized area of injection and pain up into shoulder blade.  Follow up on 11/16, pain remains, less severe.  Daughter also reacted like this to tetanus.									U	11/09/2006	11/11/2006	2		PUB	PVT		NONE				1						1	Myalgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F600311~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268323	12/05/2006	WA	38.0	38		F	11/27/2006	Employee states left arm started hurting after injection.  C/O of numbness, pain down left arm.  Hard to lift arm up.  Tried ice.  Cannot take ibuprofen.  Referred to private physician.				Y					U	11/16/2006	11/16/2006	0	Ordering nerve conduction testing at Drs. office.  Results not back yet.	PUB	PVT	Premarin, albuterol inhaler, epi pen as needed	NONE	asthma, non malignant tumor in left shoulder previously removed.			1						1	Joint range of motion decreased; Myalgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA205AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0268324	12/05/2006	TX	61.0	61		F	11/28/2006	Patient reported whole neck and upper thigh area broke out in hives.  Patient only complained of itching and reported taking Benadryl, which was alleviating her symptoms.									Y	11/22/2006	11/23/2006	1		OTH	PVT	Voltaren, MVI, Vitamin E, calcium, fish oil	NONE	NONE			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2258AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268325	12/05/2006	SC	10.0	10		M		During a mass flu clinic for adults and children I gave a child Fluarix, meant for adults 18 years old and older, by mistake.  No known adverse events.									Y	11/17/2006				PUB	UNK		NONE	None known			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA242AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268326	12/05/2006	SC	5.0	5		F	11/21/2006	During a mass flu clinic for adults and children, a child received Fluarix, meant for adults 18 years old and older, by mistake.  No known adverse events. No adverse event occured.									Y	11/17/2006				PUB	UNK		NONE known	NONE known			1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA242AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268327	12/05/2006	WV	32.0	31		F	11/14/2006	Shortness of breath, asthma like exacerbation.  Fever 102.1.									Y	10/30/2006	10/31/2006	1	NONE	PUB	PUB		NONE	Sulfa allergy.  History of diabetes mellitus and asthma.			1						1	Dyspnoea; Pyrexia	FLU3~SANOFI PASTEUR~U22422AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268328	12/05/2006	WA	0.95	0	1	F		5-6 days out had erythema around site with 1-2 very small 3 mm pustules.  ??secondary infection.									Y	11/10/2006	11/16/2006	6		PVT	UNK						1						1	Erythema; Injection site infection; Injection site rash	DTAPH~UNKNOWN MANUFACTURER~~UNK~~~DTAP + HIB (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~UNK~~~VARICELLA (NO BRAND NAME)~1	USA		Influenza
0268329	12/05/2006	SC	10.0	10		F	11/21/2006	During mass flu clinic for adults and children, a child under 18 years received 1 dose of FLUARIX meant for adults 18 years and above in error. No known adverse events. Follow-up - No adverse event occurred.									Y	11/17/2006				PUB	UNK	None	None	None			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA242AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268330	12/05/2006	WA	46.0	46		F	11/21/2006	Received Influenza vaccine 11/15/05. Reports that next day 11/16/06, redness, swelling and burning pain at site of injection and itchy rash on abdomen, scalp times 3 days. Saw PCP on 11/17/06 who RX antihistamine and Ibuprofen. No redness or swelling observed on 11/20/06. Subjection reports of decreased pain by 11/27/06.									Y	11/15/2006	11/16/2006	1		PUB	UNK		None	Unknown			1						1	Injection site erythema; Injection site pain; Injection site swelling; Pruritus; Rash	FLU3~SANOFI PASTEUR~U2204AB~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~SMITHKLINE BEECHAM~AHBV260AA~3~~RA~HEP A + HEP B (TWINRIX)~1	USA		Influenza
0268331	12/05/2006	CA	1.34	1	.3	F	11/22/2006	High fever to 103-104 degrees within 12 hours of vaccine				Y					U	11/20/2006	11/20/2006	0		PVT	PVT		None	Pectus excavatum			1						1	Pyrexia	DTAP~SANOFI PASTEUR~C2515AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2175CA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~VE950AA~4~IM~LL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08666~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0268333	12/05/2006	NM	4.0	4		M	11/22/2006	Left upper arm hot, erythematous swollen (22 cm right arm) 24.5 cm swelling 7x8cm erythema				Y					U	11/20/2006	11/21/2006	1		PVT	PUB	None	None	None			1						1	Erythema; Feeling hot; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72005c~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0268334	12/05/2006	SC	7.0	7		F	11/21/2006	During a mass Flu Clinic for adults and children, I gave FLUARIX to a child meant for adults 18 years and older by mistake. No known adverse events.  Follow-up - No adverse events occurred.									Y	11/17/2006				PUB	UNK	None known	No	None Known			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA242AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268335	12/05/2006	SC	7.0	7		F	11/21/2006	During mass Flu Clinic for adults and children I gave Fluarix to a child, meant for adults 18 years and older by mistake. No known adverse events.  No adverse events occurred.									Y	11/07/2006				PUB	UNK		None Known				1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA242AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268336	12/05/2006	SC	12.0	12		F	11/21/2006	During mass Flu Clinic for adults and children I gave FLUARIX to a child, meant for adults 18 years and older by mistake. No known adverse events.  Follow-up - No adverse events occurred.									Y	11/17/2006				PUB	UNK	None	None				1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA242AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268337	12/05/2006	SC	5.0	5		F	11/21/2006	During mass Flu Clinic for adults and children I gave Fluarix to a child, meant for adults 18 years and older by mistake. No known adverse events.									Y	11/07/2006				PUB	UNK	None	No	None known			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA242AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268338	12/05/2006	SC	3.0	3		M	11/21/2006	Vaccine administrator gave FLUARIX to a child by mistake that is meant for adults 18 year old and older.  No known adverse events.  Follow-up - No adverse events occurred.									Y	11/17/2006				PUB	UNK	None known	None	None known			1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA242AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268339	12/05/2006	SC	10.0	10		M	11/21/2006	A vaccine administrator gave Fluarix to a child meant for adults 18 years and older by mistake. No known adverse events. No adverse event occured.									Y	11/17/2006				PUB	UNK	NONE	NONE	NONE			1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA242AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268340	12/05/2006	IN	70.0	70		F		Hoarseness, fatigue. Treatment-Vicks over counter cough medicine for 2 weeks, gargled with salt water.									Y	11/01/2006	11/15/2006	14		PUB	UNK		NONE	chronic obstructive pulmonary disease			1						1	Dysphonia; Fatigue	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71210~7+~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268341	12/05/2006	SC	9.0	9		F	11/21/2006	During a mass flu clinic for adults and children, a child received FLUARIX meant for 18 year old and older by mistake. No known adverse events.  Follow-up - No adverse events occurred.									Y	11/17/2006				PUB	UNK	None known	None known	None known			1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA242AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268342	12/05/2006	SC	5.0	5		M	11/21/2006	A vaccine administrator during a flu clinic for adults and children. A child under 18 years old received 1 dose of Fluarix meant for adults 18 and older in error.  No known adverse events.  No adverse event occured.  3-28-07.									Y	11/17/2006				PUB	UNK	NONE	NONE				1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA242AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268343	12/05/2006	ME	47.0	47		F	11/28/2006	Rash all over body									N	11/26/2006	11/26/2006	0	Referred to a dermatologist.	PVT	OTH		Ear drainage, Severe drainage	None			1						1	Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72222~2~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C2457AA~2~~RA~TDAP (ADACEL)~1	USA		Influenza
0268365	12/05/2006	MI	59.0	59		F	12/05/2006	itching, redness, swelling more than 1 week. Used antihistamines.									Y	11/27/2006	11/27/2006	0		UNK	UNK						1						1	Erythema; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U2307AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268366	12/05/2006	MI	46.0	45		F	12/05/2006	erythema 15cm x 10cm, itcym red, warm to touch.									U	11/27/2006	11/27/2006	0		UNK	UNK						1						1	Erythema; Feeling hot; Pruritus	FLU3~SANOFI PASTEUR~U2307AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268367	12/05/2006	FL	57.0	57		M	12/05/2006	Two days after shot I started to feel terrible with difficult breathing, wheezing, paleness, weakness, ears plugged bad, dizzines, depression, light fever, chills, cold sweating, back pains,light skin irritation, nose congestion.  Today 12/05/06 after more than 4 weeks and three medical visits I still have some of the symptoms described.				Y					Y	10/30/2006	11/01/2006	2	Per family Doctor it was an Adverse reaction to the Flu Shot.	UNK	UNK	none	none	none			1						1	Back pain; Chills; Depression; Dizziness; Dyspnoea; Ear discomfort; Hyperhidrosis; Malaise; Nasal congestion; Pallor; Pyrexia; Skin irritation; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71826~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0268368	12/05/2006	MI	57.0	57		F	12/05/2006	erythema 1.5 x 1.0, redened, warm to touch. Used ice & Ibuprofen.									U	11/27/2006	11/27/2006	0		UNK	UNK						1						1	Erythema; Feeling hot	FLU3~SANOFI PASTEUR~U2307AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268369	12/05/2006	MH	59.0	59		M	12/05/2006	redness, warm to touch, swelling.									U	11/29/2006	11/29/2006	0		UNK	UNK						1						1	Erythema; Feeling hot; Swelling	FLU3~SANOFI PASTEUR~U2307AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268370	12/05/2006	AR	36.0	36		F	12/05/2006	Chest pain, SOB, nausea, abnormal EKG and elevated blood pressure within 48 hours of shot.  Pain decreased with nitro. Transported to ER by ambulance admitted for 3 days heart cath performed and within normal range and normal cardic enzymes within first 48 hours of chest pain. 12/22/06-records received and reviewed. Cardiac consultation Impression: angina symptoms Hypertension.  Seen in ER with C/O dizziness, sudden onset of chest pain. Echocardiogram: normal left ventricular systolic function with an estimated ejection fraction of 55 to 60% without any evidence of left ventricular hypertrophy, dilatation or regional wall motion abnormalities. Cardiac angiography: no coronary stenosis, no coronary anomaly, no bridging coronary arteries, normal left ventricular systolic function, normal left ventricular end diastolic pressure at 10mmHg.				Y	Y	3			Y	11/27/2006	11/29/2006	2	EKG, heart cath, lab work and echo Labs WNL Urine culture positive for E.coli EKG: NS rhythm.	MIL	OTH	Robaxin and Wellbutrin	none	Herniated disc cervical and lumbar			1						1	Angina pectoris; Blood pressure increased; Chest pain; Dyspnoea; Electrocardiogram abnormal; Hypertension; Nausea; Urine analysis abnormal	FLU3~SANOFI PASTEUR~U2259AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0268371	12/05/2006	NY	57.0			F	12/05/2006	Pain throughout arm, mostly on top, sometimes a burning sensation, like nerves.  Needed to take tylenol with codeine. Complains wasn't given correctly.														UNK	UNK	Unknown	Denies				1						1	Pain	FLU3~SANOFI PASTEUR~U2256AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0320F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268372	12/05/2006	MI	67.0	67		F	12/05/2006	Complained of itchy on stomach, arms, legs with rash.  Denies swelling, SOB.									Y	10/22/2006	10/23/2006	1	None	UNK	UNK	Unknown	No	Unknown			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U2213AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268373	12/05/2006	MI	68.0	67		F	12/05/2006	Immediate redness and swelling at the injection site.									Y	10/29/2006	10/29/2006	0	None	UNK	UNK	Unknown	No	Unknown			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2213AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268374	12/05/2006	MI	54.0	54		F	12/05/2006	Lump at injection site immediately following injection.									Y	11/02/2006	11/02/2006	0	None	UNK	UNK	Unknown	No	Unknown			1						1	Injection site mass	FLU3~SANOFI PASTEUR~U2213AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268375	12/05/2006	MI	41.0	41		F	12/05/2006	Woke up morning after receiving flu shot with hives on face, chest, neck arms.  Denies SOB.  Hives were itchy.									Y	11/05/2006	11/06/2006	1	None	UNK	UNK	Unknown	No	Unknown			1						1	Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71926~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268378	12/05/2006	WA	31.0	31		F	12/05/2006	pt returned to clinic about 2hrs after vaccination with complaint of pruritis and rash on face, trunk & arms. Pt devloped erethematous macular rash & discrete wheals on face, chest, back, abdomen and upper extremeties & wheals on lower extremities.  Pt received 50mg Diphenhydramine IM and was sent home with diphenhydramine 25-50mg po q6h prn.				Y					Y	11/30/2006	11/30/2006	0		UNK	UNK	Depo-Provera also given at same visit.					1						1	Erythema; Pruritus; Rash; Rash macular; Urticaria	FLU3~SANOFI PASTEUR~U2251AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268379	12/05/2006	IL	69.0	69		F	12/05/2006	Pain radiating down left arm.									Y	11/14/2006	11/14/2006	0	Unknown	UNK	UNK	unknown	unknown	unknown			1						1	Pain	FLU3~SANOFI PASTEUR~u2189aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0985f~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268381	12/05/2006	AR	29.0	29		F	12/05/2006	I took the vaccination on Monday 11/28/06. I experience a week of nausea, unusual fatigue, and headaches.  By the end of week I was so nauseated that couldn't really eat.  I didn't take any medicine. By the weekend, I started feeling better.									Y	11/28/2006	11/29/2006	1	None	MIL	MIL		None				1						1	Decreased appetite; Fatigue; Headache; Nausea	FLU3~SANOFI PASTEUR~U2308AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268382	12/05/2006	MS	0.53	0	.5	F	11/29/2006	Grandmother called HD and said Dr. said 6 month old shouldn't get flu vaccine That it made baby very sick and they were taking baby to Dr. the next day. Regular immunizations and flu were given 11/21/2006. Baby was taken to doctor 6 days later 11/28/2006. Upon talking to baby's mother on 11/29/2006, she stated the baby ran temp 100.4 on the day after the shots.  States doctor gave cough and cold medication.									Y	11/21/2006	11/22/2006	1	NONE	UNK	UNK	Only RSV Shots	None	Premi		MS06018	1						1	Medication error; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B069AA~1~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2174HA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0086F~1~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08672F~1~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0268384	12/05/2006	TX	31.0	31		M	12/05/2006	Fever and fatigue 2 weeks post vaccination, noticed maculopapular lesions on trunk, face and arms over several days.									U	11/16/2006	11/30/2006	14	T = 98.1F	UNK	UNK						1						1	Fatigue; Pyrexia; Rash maculo-papular	FLU3~SANOFI PASTEUR~U2242AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2559AA~1~IM~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~0794F~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0268393	12/05/2006	NY	0.55	0	.5	F	11/27/2006	Noticed two nodules swelling around Nov 15th on Right thigh. Slowly came to surface. No complaint of fever, pain, redness. No notice of decreased movement on extremities or any pus.				Y					U	10/27/2006	11/15/2006	19	Clinical evaluation	PVT	PUB						1						1	Injection site nodule	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B069AA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT21732A~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0089R~3~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08672F~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0268395	12/05/2006	WA	4.0	4		F	12/04/2006	2 days after receiving intranasal FluMist vaccine developed pain in hand/feet, general myalgias, itching of skin with rash, mild swelling of the real symptom with erythema.										12/01/2006	12/04/2006	3	NONE as of 12/04/2006.	PVT	PUB		Chin laceration otherwise healthy	NONE			1						1	Erythema; Myalgia; Oedema peripheral; Pain; Pain in extremity; Rash; Skin irritation; Swelling	FLUN3~MEDIMMUNE VACCINES, INC.~500442P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0267817	12/06/2006	VA	2.0	2	.5	F	11/30/2006	Sudden onset left eye esotropia 4 days after Fluzone vaccine.				Y	Y	4			N	11/09/2006	11/13/2006	4		PVT	PVT						1						2	Balance disorder; Blindness; Blood potassium increased; Blood test; Blood urea nitrogen/creatinine ratio increased; Coordination abnormal; Haematocrit normal; Haemoglobin normal; Haemolysis; Headache; Intracranial pressure increased; Lumbar puncture; Neutrophil count increased; Nuclear magnetic resonance imaging; Ophthalmoplegia; Strabismus; Surgery; Visual impairment; White blood cell count normal; Strabismus	FLU3~SANOFI PASTEUR~U2247AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2247AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0268400	12/06/2006		46.0			M	12/01/2006	From initial information received on 1/21/06 from a literature report. A report of three cases, it was reported that three pts were evaluated at the neuromuscular clinic from 2001 to 2005, All pts underwent detailed history, general and neurological examinations, electro diagnostic and lab studies, including spinal fluid, complete blood count, metabolic panel, serology for autoimmune disorders, Lyme serology, VDRL, serum immune fixation, thyroid studies glucose and HBA1C, and MRI for brain and spine. The other two pts from this literature report are reported in cases 200603299 and 200603300.   A healthy 46 year old man had received a dose of Influenza vaccine sometime in 2001 to 2005. The date of vaccination was not specified. The trade name, manufacturer, lot number, route and site of administration were not reported. The pt did not have any acute illness or systemic infections prior to the vaccination. He did not have any history of diabetes mellitus, alcohol abuse, exposure to any known neurotoxins, and there was no family history of neuropathy. Seven days after receiving the influenza vaccine the pt experienced sensation of burning, tingling, and itching over the trunk. Over the next 10 days he developed difficulty chewing, bilateral facial weakness and diplopia, along with tingling and numbness in feet and hands, mild weakness in limbs, and gait difficulty, all tendon reflexes were absent. Sensation were normal. Spinal fluid protein was 142 mg/dl with 2 lymphocytes and normal glucose. Electro diagnostic studies were unremarkable except for mild impersistence of median nerve F waves (4 to 10) with normal latencies. Needle EMG testing of distal lower extremity muscles was unremarkable. Blink reflex showed absent R1 and R2 responses bilaterally and normal response with direct facial stimulation, suggesting a proximal conduction block. Cranial MRI showed subtle enhancement of facial nerves. Pt was treated with a 5 day course of IVIG 0.4 g/kg per day and improved. Four weeks later, the pt noted increasing numbness in toes and hands as well as increasing weakness in ankles with decreased balance and gait difficulty. Examination showed weakness with grade 4 MRC strength in intrinsic hand muscles, hip flexors, and ankle dorsiflexion. Muscle stretch reflexes were diminished in the arms and absent at knees and ankles, vibration and pin sensation were diminished in feet with preserved proprioception. Electrodiagnostic studied showed widespread abnormalities, indicating a demyelinating polyneuropathy, median and ulnar sensory potentials were absent, and sural sensory potentials were preserved. The pt was treated with IVIG 1g/kg monthly for four months and improved promptly. He experienced another relapse, which responded to pulse IV methylprednisolone 1000 mg/wk, and developed gastrointestinal side effects. There after he was treated with monthly IVIG and oral mycophenolate was added 1g twice a day. Th pt has not required IVIG for one year and remains free of relapses. The pts status at the last follow up showed that he had no deficits. The authors conclusion is that this pt , who was other wise health, developed CIDP with rapid onset in close proximity to influenza vaccinations, suggesting a plausible relationship between the immunization and the induction of CIDP. It is possible that antecedent events such as immunization are more likely in such pts,  but has not been systemically evaluated. In contrast to GBS, which is a monophasic illness, how a single event such as immunization may trigger induction of a relapsing or chronic immune mediated disorder such as CIDP is not known. The reporter for this case is the same as for cases 200603299, and 200603300.				Y					Y					UNK	UNK					200603298	1						1	Asthenia; Balance disorder; Conduction disorder; Demyelination; Diplopia; Gait disturbance; Gastrointestinal disorder; Hyporeflexia; Laboratory test abnormal; Muscle disorder; Paraesthesia; Polyneuropathy; Pruritus; Sensory disturbance; Skin burning sensation	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0268401	12/06/2006	MA	53.0	53		M	12/01/2006	A 53 year old male pt, with a history of previous atrial fibrillation, cardioversion, and depression, had received an injection of Fluzone SV 2006-2007, lot number unk, on 11/30/06. Route and site of administration were not reported.  Within one minute post vaccination, the pt went into ventricular fibrillation arrest. He was subsequently shocked times two. The pt was hospitalized and is now in atrial fibrillation. Illness at the time of vaccination was unk. Concomitant medications included daily aspirin and fish oil. Wellbutrin was discontinued. At the time of this report, the pt had not recovered.					Y	0			N	11/30/2006	11/30/2006	0		PUB	PUB	ASA, Fish Oil		The patient had a history of atrial fibrillation, cardioversion, and depression.		200603304	1						1	Atrial fibrillation; Condition aggravated; Ventricular fibrillation	FLU3~SANOFI PASTEUR~~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0268402	12/06/2006		89.0			M	12/04/2006	Seriousness criteria other medically significant (OMIC). From initial information received on 1/21/06 from a literature report. a report of three cases, it was reported that three pts were evaluated at the neuromuscular clinic from 2001 to 2005, All pts underwent detailed history, general and neurological examinations, electro diagnostic and lab studies, including spinal fluid, complete blood count, metabolic panel, serology for autoimmune disorders, Lyme serology, VDRL, serum immune fixation, thyroid studies glucose and HBA1C, and MRI for brain and spine. The other two pts from this literature report are reported in cases 200603299 and 200603300. A healthy 89 year old man had received a dose of Influenza vaccine sometime in 2001 to 2005. The date of vaccination was not specified. The trade name, manufacturer, lot number, route and site of administration were not reported. The pt did not have any acute illness or systemic infections prior to the vaccination. He did not have any history of diabetes mellitus, alcohol abuse, exposure to any known neurotoxins, and there was no family history of neuropathy. The pt developed tingling in the hands two days post immunization, followed by progressive weakness, which progressed over two weeks, in his arms and legs. CSF showed 127.3. The pt improved after a05 day course of IVIG over 4 weeks, a month later, the pt experienced more gradual worsening of weakness over 6 weeks, the pt was unable to walk or stand, even with support. Examination showed marked weakness in proximal and distal muscles of all extremities, with absent muscle stretch reflexes. Vibration and diminished in the toes, and other sensations were intact. Electro diagnostic studied showed widespread abnormalities, indication a demyelinating polyneuropathy. Needle EMG showed fibrillation potentials, and loss of motor unit potentials, in the distal upper and lower extremity muscles. Pt was treated with monthly IVIG 1g/kg monthly) and oral mycophenolate 1000 mg bid. IVIG was discontinued after 6 months, at the 16 month follow up, the pt showed normal gait and only mild weakness of intrinsic hand muscle (grade 4 MRC). Pts status at the last follow up indicated that he was ambulating with a cane, and had mild weakness in his arms. The authors conclusion is that this pt , who was other wise health, developed CIDP with rapid onset in close proximity to influenza vaccinations, suggesting a plausible relationship between the immunization and the induction of CIDP. It is possible that antecedent events such as immunization are more likely in such pts,  but has not been systemically evaluated. In contrast to GBS, which is a monophasic illness, how a single event such as immunization may trigger induction of a relapsing or chronic immune mediated disorder such as CIDP is not known. The reporter for this case is the same as for cases 200603300 and 200603298.				Y					N					UNK	UNK					200603299	1						1	Abasia; Asthenia; CSF test abnormal; Demyelination; Gait disturbance; Hypokinesia; Hyporeflexia; Laboratory test abnormal; Muscular weakness; Paraesthesia; Polyneuropathy	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0268403	12/06/2006		84.0			F	12/04/2006	Seriousness criteria other medically significant (OMIC). From initial information received on 11/21/06 from a literature report. A report of three cases, it was reported that three pts were evaluated at the neuromuscular clinic from 2001 to 2005, All pts underwent detailed history, general and neurological examinations, electro diagnostic and lab studies, including spinal fluid, complete blood count, metabolic panel, serology for autoimmune disorders, Lyme serology, VDRL, serum immune fixation, thyroid studies glucose and HBA1C, and MRI for brain and spine. The other two pts from this literature report are reported in cases 200603299 and 200603300. A healthy 84 year old female had received a dose of Influenza vaccine sometime in 2001 to 2005. The date of vaccination was not specified. The trade name, manufacturer, lot number, route and site of administration were not reported. The pt did not have any acute illness or systemic infections prior to the vaccination. He did not have any history of diabetes mellitus, alcohol abuse, exposure to any known neurotoxins, and there was no family history of neuropathy. Twenty one days post immunization, the pt experienced severe pain in a band like distribution in the mid thoracic region. Four days later, she experienced progressive weakness and numbness which progressed over 6 weeks, in her legs and hands. She was able to take a few steps with a walker, and she had marked weakness in proximal and distal muscles of upper lower extremities. Muscle stretch reflexes were absent in the legs and diminished in the arms, vibration was absent in the feet, but proprioception and pin sensation were intact. Gait was broad based and ataxic. Her CSF was 136.0. The pt did not improve with a 5 day course of IVIG. She was then treated with weakly oral prednisone starting at 150 mg/wk for 2 months followed by a slow taper to 20 mg/wk, At 14 months follow up, the pt is able to ambulate without assistance, and she has mild weakness (grade 4 MRC) in deltoid, intrinsic hand muscles, and hip flexion. Reflexes remain absent in the lower extremities. The pts status at the last follow up indicated that she could ambulate independently, and had mild weakness in her arms. The authors conclusion is that this pt , who was other wise health, developed CIDP with rapid onset in close proximity to influenza vaccinations, suggesting a plausible relationship between the immunization and the induction of CIDP. It is possible that antecedent events such as immunization are more likely in such pts,  but has not been systemically evaluated. In contrast to GBS, which is a monophasic illness, how a single event such as immunization may trigger induction of a relapsing or chronic immune mediated disorder such as CIDP is not known. The reporter for this case is the same as for cases 200603299, and 200603298.				Y					N					UNK	UNK					200603300	1						1	Asthenia; Coordination abnormal; Demyelination; Gait disturbance; Hypoaesthesia; Hyporeflexia; Muscular weakness; Pain; Polyneuropathy	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0268410	12/06/2006	CO	4.0	4		F	11/30/2006	Patient received immunizations 11/27/06. Patient reaction started 11/29/06 per moc patient had a cyst form @ site of DTAP when she was little also. 11/30/06 patient came in because of DTAP reaction. Put on Keflex, ice pads, Tylenol/Motrin PRN.				Y					U	11/27/2006	11/29/2006	2	None	PVT	PVT	None	None	Neomycin allergy	reaction~DTaP (no brand name)~2~0.30~In Patient		1						1	Cyst	DTAP~SANOFI PASTEUR~C2490AA~3~IM~~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2281AA~2~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0991~5~IM~~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0862F~4~IM~~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1066F~2~SC~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0268412	12/06/2006	MA	25.0	25		M	12/03/2006	Patient presented with blotches and a rash on face, forearms, and chest. No rash noted on abdomen. Breath sounds equal and clear, no shortness of breath reported. Pulse 76, respirations 14, B/P 133/73 (RA). No itchiness reported. Patient given two Benadryl 25 mg each and observed for 15 minutes.									Y	12/03/2006	12/03/2006	0	N/A	MIL	MIL		None	None			1						1	Rash; Rash macular	FLUN3~MEDIMMUNE VACCINES, INC.~500440P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0268413	12/06/2006	VA	47.0	46		M	11/30/2006	Client reported he developed oval blotches on his skin on 08Nov06, the day after receiving FluMist (first time), he was in NYS and went to ER (Cortland Regional Medical Ctr) and was DX with erythema multiforme advised this clinic of event 27Nov06. Oval patches persist has F/U appt with his MD 13Dec06.				Y					N	11/07/2006	11/08/2006	1		UNK	UNK		None	NKDA, no birth defects, PE 1982, DVT right calf 1996 (on coumadin therapy monthly F/Us.			1						1	Erythema multiforme; Rash macular	FLUN3~MEDIMMUNE VACCINES, INC.~500433P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0268423	12/06/2006	MO		82		F	11/06/2006	Cellulitis reaction to vaccine pt received pneumonia and influenza vaccine in right arm on 11/03/06. Pt seen 11/06/06 with about 8x3 RUA, DX with cellulitis, responded well to Augmentin.										11/03/2006	11/03/2006	0		UNK	UNK						1						1	Cellulitis; Injection site reaction	FLU3~SANOFI PASTEUR~U2211AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0268429	12/06/2006	NJ	2.0	2	.0	F	12/04/2006	Facial rash which was hive like in appearance appeared in face in butterfly like pattern in 5-7 minutes after vaccine given. No resp symptoms, rash after observing 30 min.									Y	11/22/2006	11/22/2006	0	NONE	PVT	PUB						1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~U22751A~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268430	12/06/2006	MN	18.0	18		F	12/06/2006	11/07/06 1st 12/06/06 2nd vac. No adverse effects, Accidentally  given pregnant (26 5/7 weeks) a second flu vaccine, reported per phone 12/06/06 conversation will not cause harm but is off label use so must report.										12/06/2006				PVT	OTH	Prenatal vitamins	NONE	NONE			1						1	Medication error	FLU3~SANOFI PASTEUR~U2196AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268431	12/06/2006	PA	8.0	8		F	12/06/2006	Left leg swollen at injection site. Area quarter to 50 cent piece size on 11/30/06. By 12/01/2006 area enlarged and child complained of standing on right leg. Pt seen in ER.				Y					Y	11/29/2006	11/30/2006	1		PUB	PVT	Albuterol, Asmanex	NONE	Asthma			1						1	Hypokinesia; Injection site oedema	FLU3~SANOFI PASTEUR~U2250AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1055F~2~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0268432	12/06/2006	MI	59.0	58		F	12/06/2006	Swelling and redness from injection site down to elbow.  Erythematous, swollen and very painful.				Y					U	11/28/2006	11/28/2006	0		UNK	UNK	Alprazolame Cartia XL Premarin Xanax	none	Patient stated allergies; augmentine, vibra tab, erythromycin, ceclo, morphine, vicodin, zithromax, biaxin, sulfa drugs, codiene.			1						1	Injection site erythema; Injection site swelling; Pain	FLU3~SANOFI PASTEUR~U2285AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0619F~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0268433	12/06/2006	AR	51.0	51		M	12/06/2006	Within 24 hours of injection started to feel tired and weak with onset of headache by evening of that same day, low grade fever with head and chest congestion lasting 4-5 days.									Y	11/28/2006	11/29/2006	1	None	MIL	MIL	Lisinopril 20mg per day Aciphex 20mg per day	Starting to feel like a URI might be coming on.	None			1						1	Fatigue; Headache; Nasal congestion; Pyrexia	FLU3~SANOFI PASTEUR~U2308AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268434	12/06/2006	NY	0.0	69		F	12/06/2006	Severe arm and shoulder pain x 5days( unable to lift arms), but continued discomfort for approx. 10 - 14 days.  Recieves flu every year first time with this reaction.									Y	11/01/2006	11/02/2006	1		UNK	UNK		denies	neurofibromyalgia osteoarthritis joint replacements, shoulder, hip			1						1	Pain; Shoulder pain	FLU3~SANOFI PASTEUR~U2256AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0320F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268436	12/06/2006	FL	0.0	57		M	12/06/2006	According to Occupational Health Nurse and a incident report, patient reported he received a flu vaccine on the morning of 10-26-06; on 10-27-06 he began to experience a mild reaction of fever and hives; on 10-28-06, these symptoms increased in severity, which sent him to be seen at the doctors. He was seen, treated, and released with medication from a doctor. He has had a flu recovery to his pre-vaccine state.				Y					Y	10/26/2006	10/27/2006	1	None noted on the report.	UNK	UNK						1						1	Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U2167NA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268438	12/06/2006	FL	0.0	67		M	12/06/2006	According to the Occupational Health Nurse, patient received the flu vaccine on 11-2-06, on 11-3-06 began complaining of itching and a rash generally over body. He went to a doctor and received medication for symptoms and has made a full recovery back to his pre-vaccine state.				Y					Y	11/02/2006	11/03/2006	1	none reported or documented	UNK	UNK	none reported or documented	none reported or documented	none reported or documented			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U2166KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268439	12/06/2006	MI	30.0	30		M	12/06/2006	Headach, Nasal congestion /bleeding, Sore throat, Burning sensation in lungs and eyes. Coldlike symptoms. Started the day after receiving Flu Vaccination. One other coworker here received the vaccination with me, experienced same symptoms. None of the other 12 people here currently sick and none of them received the flu shot.									U	11/29/2006	11/30/2006	1		UNK	UNK			Sulfa			1						1	Epistaxis; Headache; Nasal congestion; Pharyngitis; Pharyngolaryngeal pain; Rhinitis	FLU3~SANOFI PASTEUR~u2217aa~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268440	12/06/2006	IN	27.0	27		F	12/06/2006	About an hour after receiving the shot at a free flu shot clinic at work, I suddenly felt light-headed and passed out. After regaining conciousness, I felt nauseous and got sick twice that night. Since I passed out at work, my coworkers called an ambulance but I didn't feel bad enough to go with them.									Y	12/04/2006	12/04/2006	0	none	UNK	UNK	Yasmin					1						1	Dizziness; Loss of consciousness; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0268441	12/06/2006	WY	54.0	54		F	12/06/2006	Shot area itched. The second day I had chills and a rash. The third day in the pm I experienced dizziness, difficulty breathing, nausea, and hoarseness. The fourth day in the am I still experienced dizziness and nausea. It finally went away in the afternoon. The next couple of days I have still had a feeling of lightheadedness but am able to work. I took Benedryl for the rash.									Y	12/01/2006	12/01/2006	0		UNK	UNK			I have allergies to various things such as trees and weeds. CFS			1						1	Chills; Dizziness; Dysphonia; Dyspnoea; Injection site hypersensitivity; Nausea; Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0268442	12/06/2006	MA	53.0	53		M	12/06/2006	53 y/o male with history of atrial fibrillation (only on ASA) was in his normal state of health on morning of 11/28/2006.  At about 9:30am, patient received Fluzone vaccine (5cc, Sanofi-Pasteur) while at work.  At ~ 10:45am, pt was sitting in a meeting with another peer, began to stare blankly at the peer, and then went into a convulsion/seizure episode and incontinence. At that time, another co-worker noted that pt had a swollen tongue/mouth/neck.  O2 via face mask was provided and bystander CPR was performed for ~ 2-3 min. EMS services arrived, found the patient in polymorphic VT arrest. Shock 200J -> CPR -> VT arrest -> Shock 200J -> CPR -> VT arrest -> Shock 300J -> CPR -> Asystole. Pt then given epinephrine x 1 and then atropine x 1, intubated in the field. Pt transferred to hospital.  He was found to be in Atrial Fibrillation, 190s-200s rate and SBP in 110s. Unclear why, but patient was re-intubated on etomidate, vecuronium (possibly due to mental status unresponsiveness). Pt had an ECHO performed, found to have RV/LV dysfunction and global hypokinesis. There was a questionable repeat seizure activity in which the patient responded to Ativan 2mg. A CT head was then conducted demonstrating no acute hemorrhage/bleed. The patient subsequently went int a rapid AFib with a fall in SBP to the 80s. He was given Metoprolol 2.5mg IV x 2, then started on an esmolol drip and transferred to another hospital for further care. Labs from hospital: Trop I 0.018, Myo 474, Ast 124, Alt 108 On arrival, the patient was on esmolol drip w/ SBP 70s.  Esmolol drip discontinued with immediate restoration of SBP to 90s->110s.  At this point ABG: 7.27/43/402/21 on AC 650 X 16 Peep 5 100% FiO2.  Pupils pinpoint, no eyelash reflex, but bilateral LE withdrawing to pain, L babinski up, R no response.  Approximately 30 minutes into hospitalization, patient experienced a tonic posturing (upper extremities curled, lower extremities straightened), was grimacing, had rhythmic contractions of abdominal muscles, and no longer responsive to painful stimuli. He was thought to be experiencing a seizure, given Ativan 2mg with no response, then Ativan 4mg bolus with subsequent response. He was then started on a versed drip. On admission to BIDMC, pt's labs are as follows: wbc 12.1, K 5.6, AST 113, ALT 107, LDH 33, CK 396. On 11/28/06, a stat ECHO revealed ejection fraction of 15% and global hypokinesis. Given the polymorphic VT arrest and rapid AFib events, pt was taken to emergent cardiac catheterization for evaluation. Fortunately, pt had clean coronary arteries and no further intervention at that time. Of note, a CT of his chest indicated bilateral pleural effusions and associated compressive atelectatis. The CT Abd/Pelvis/Head were negative.  Neurology was consulted regarding patient's mental status, an EEG demonstrated encephalopathy but a repeat head CT was negative for bleed. Further evaluation on 11/30/06 demonstrated a normal MRA brain, MRI head.  Since that time, patient has improved in mental state and respiratory status, all drips discontinued and patient extubated on 11/30/06. Patient had an AICD placed on 12/04/06 while in-house. Of note, he had developed an elevated white blood cell count to 12.1, was febrile to 102, and CT chest indicated bilateral pleural effusions. Concern for possible aspiration pneumonia, and patient had been started on levofloxacin and metronidazole for a suspected aspiration pneumonia. Sputum cultures demontrated Haemophilus influenzae growth, metronidazole discontinued and pt maintained on levofloxacin. Patient is now doing well, continues to have some mild agitation. He recalls no events from 2-3 days prior to the vaccination and onward. He does not recall being vaccinated on 11/28/06. Family and patient report that he was afebrile prior to the event.  Vaccination History: Patient does report prior vaccinations. Occupational Health stated that patient reported influenza vaccination in 2004.				Y	Y	9	Y		Y	11/28/2006	11/28/2006	0	Please see above in section 7.	UNK	UNK	ASA 81 mg Viagra Vitamin Supplements Fish Oil	1. ? anaphylactic-type reaction with swollen mouth/tongue/neck 2. Seizure-like event with convulsions/incontinence 3. Polymorphic VT arrest	1. Atrial Fibrillation, diagnosed ~ 5 yr ago. On coumadin for ~ 1 yr per patient/wife. Failed cardioversion attempt x 1 in 2001. Received flecanide following cardioversion, family-reported reaction with numbness/tingling. Not taking beta-blockers given erectile dysfunction effects. Currently maintained on aspirin 81mg. Now s/p AICD placement 12/04/06. 2. Plantar fasciitis 3. Inguinal Hernia			1						1	Atelectasis; Atrial fibrillation; Blood pressure decreased; Convulsion; Encephalopathy; Hypokinesia; Pleural effusion; Pneumonia; Pyrexia; Staring; Tongue oedema; White blood cell count increased	FLU3~SANOFI PASTEUR~U2184AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0268443	12/06/2006	GA	22.0	21		F	12/06/2006	Admitted via ER on 11/28/06 with paresthesias in both legs. Illness worsened and she now is in a coma in the neuro ICU with unknown diagnosis. On admit to ER, stated had received a flu vaccine one week earlier. Date of vaccination is estimated and not exact date. 02/01/07 records received and reviewed for DOS 11/26/06-01/23/07 DC DX: Acute disseminated encephalomyelitis Remote history of bulimina nervosa Spasticity secondary to acute dissseminated encephalomyelitis Diarrhea, chronic Respiratory failure with permanent tracheostomy, status post prolonged respiratory failure on vent previously. Methicillin resistant Staphylococcus aureus colonization, status post Baclofen pump placement for spasticity. Protein calorie malnutrition on feeds via percutaneous endoscopic gastrostomy tube. DC to long term care facility PE: positive for total paresthesia and now complete paralysis of arms and legs. No respiratory distress or chest pain. Pain in all 4 extremities. Developed respiratory distress and insufficiency, extensor posturing to deep painful stimuli, clonus and positive Babinski. Treatment included plasmapheresis and Solu-Medrol.  Developed bulbous type rash of buttocks and posterior thigh, suspect may be autoimmune.  WBC:range from 6.3-22.8, sed rate 47, ionized Ca 5.36-5.70, CRP 0.7-11.2, measles AB IGG positive ISR, mumps AB IGG positive ISR, blood culture enterococcus faecalis, pseudomonas mendocina, urine culture postive E.coli and candida albicans and pseduomonas aeruginosa, sputum culutre positive staph aureus MSRA and stenotrophomonas maltophilia, cath tip culture pseudomonas aeruginosa, herpes simplex PCR negative, Epstein Barr virus positive, CMV AB IGG 10.60, lymphocyte subset panel ABS CD4 177, CD8 998, CD3 1191, CD8 0.18, viral culture of brain negative.HIV1 negative, histoplasma antigen AG negative. Brain biopsy:intact myelin staining seems to make multiple sclerosis less likely. Vasculitis is not appreciated. A microinfarct may bet he cause although axonal staining is intact in the majority of the tissue. Macrophage infiltrates and reactive gliosis			Y		Y	65			N	11/21/2006	11/28/2006	7	MRI:periventricular white matter changes which have been stable, appear somewhat consistent with ADEM. LP in ER protein 31, glucose 58, one WBC and no RBC, differential was 68% lymphocytes and 33% monocytes. Multiplanar images of T spine showed a small right paracentral T9-10 protrusion without central canal or foraminal compromise, cholelithiasis without cholecystitis and no evidence for abnormal cord fosaa arachnoid cyst versus a giant cisterna magna and otherwise unremarkable MRI and no evidence for abnormal cervical spine. WBC 6.8 with 48% neutrophils and 39% lymphocytes.	UNK	UNK	Spiralactone		Drug abuse history, Long history of bulemia			1						1	Coma; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0268444	12/06/2006	CA	6.0	6		M	12/06/2006	Patient experienced a large local reaction extending from elbow to shoulder, myalgias, fatigue, headache, neck pain, and fever to 104.  His visit to the emergency room resulted in a full fever/sepsis workup to include lumbar puncture.  His WBC was extremely elevated at 43,000 with a predominantly left shift.  He was admitted to the hospital and started on rocephin prophylactically.  He did well in the hospital with resolution of his leukomoid reaction and no other cause for symptoms was found.  1/18/07 Received medical records which reveal patient admitted to hospital from 12/2-12/5/06 with fever & r/o meningitis after complaints of headache & neck pain.  All vax had been given in left deltoid & had also developed erythema, tenderness & warmth over left arm.  Temp was 104 on admit.  Improved significantly on antibiotics.  Headache & neck pain resolved, left arm improved & was afebrile for 24 hours prior to d/c to home on continued oral antibiotics.  When seen in clinic on 12/8 was back to baseline & WBC was 11.6, H/H 9.6/29.0  FINAL DX: immunization reaction; & respiratory syncytial virus bronchiolitis.				Y	Y	2			Y	11/30/2006	12/02/2006	2	WBC 43000 with 87% segs, 7% bands, remainder lymphs.  CSF and blood cultures were negative. LABS: WBC 40,000.  H/H 8.0/23.6, Retic count 10.  LP revealed CSF as WNL.  CXR revealed RAD of viral etiology.	MIL	MIL	Flovent, Zyrtec	None	Hereditary spherocytosis, asthma, allergic rhinitis			1						1	Fatigue; Headache; Myalgia; Neck pain; Pyrexia; Sepsis; White blood cell count increased	FLU3~SANOFI PASTEUR~U2259AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0391F~1~IM~LA~PNEUMO (PNEUMOVAX)~1|VARCEL~MERCK & CO. INC.~1051F~2~IM~LA~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0268447	12/06/2006	CA	24.0	25		F	12/06/2006	Patient had a flu shot on 11/29/06. Patient returned to clinic on 12/1/06 with a hard lump on left upper arm. Patient had a local reaction.				Y					U	11/29/2006	12/01/2006	2	none	UNK	UNK						1						1	Injection site induration	FLU3~SANOFI PASTEUR~U2165EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268448	12/06/2006	MN	1.26	1	.3	M	12/06/2006	One week after vaccines, developed fever.				Y					U	11/27/2006	12/05/2006	8		UNK	UNK	none	no	no			1						1	Pyrexia	DTAP~SANOFI PASTEUR~C2490AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2200LA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0616F~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0964F~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0268449	12/06/2006	FL	26.0	26		M	12/06/2006	Pain in arm/shoulder where vaccination was given for at least 2 weeks after vaccination was administered.  Vibrations felt from top of shoulder down through finger tips very often - and especially during physical activity.									N	11/01/2006	11/02/2006	1	None.  Scheduled to see general practitioner.	UNK	UNK		None	Stickler's Syndrome			1						1	Shoulder pain; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70739~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268450	12/06/2006	AR	45.0	45		M	12/06/2006	FEVER, HOT FLASHES AND A TIGHT FEELING IN THE UPPER CHEST REGION.  EVENT LASTED FOR 2 HOURS.									Y	11/28/2006	11/28/2006	0		MIL	MIL		NONE	NONE			1						1	Chest discomfort; Hot flush; Pyrexia	FLU3~SANOFI PASTEUR~U2308AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268452	12/06/2006	SD	73.0	73		M	12/06/2006	11/10/06  PHONE CALL REPORTING REDNESS, INFLAMMATION, SWELLING NOTED TO WRIST.  AUGMENTIN 875 BID X 7 DAYS ORDERED.									Y	11/08/2006	11/10/2006	2		UNK	UNK	ZOCOR,LISINOPRIL,ASA					1						1	Injection site erythema; Injection site inflammation; Injection site swelling	FLU3~SANOFI PASTEUR~U2286AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0985F~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268453	12/06/2006	ND	52.0	52		M	12/06/2006	MOTHER STATES SYMPTOMS STARTED ON THE 15TH OR 16TH.  HE COMPLAINED OF SORE THROAT.  MOTHER STATES HE HAD DIFFICULTY BREATHING, HOARSENESS, WHEEZING, PALENESS, WEAKNESS, A FAST HEART BEAT AND DIZZINESS.  DENIES HIVES.  HE WAS TAKEN TO ER ON 11/19.  SHE SAID HIS HEART RATE IN ER WAS 152 AND HIS BP VERY LOW.  HE WAS DIAGNOSED WITH PNEUMONIA.  HE HAD A RESPIRATORY ARREST AND THEN LATER KIDNEY FAILURE. PARENTS CAME AND REPORTED THIS TO FIRST DISTRICT BECAUSE  THE CLINIC HAD TOLD THEM TO.  THEY WERE RELUCTANT TO GIVE THEIR ADDRESS AND THEIR NAMES.  WE HAVE BEEN THROUGH ENOUGH.  12/8/06 Received medical records from 1st hospital which reveal patient admitted 11/19/06.  Patient had 4 days of sore throat, fever, dry cough & diarrhea.  Patient continued to deteriorate, coded & expired on 11/22/06.  No autopsy was done. LABS: CXR hazy infiltrates in bilateral lung bases. CT of abdomen & pelvis WNL.  US of kidney was WNL.  CK 11, 046 & troponin 0.24. Bone marrow biopsy done was WNL.  WBC 9.21, plts 99, Na 131, elevated liver enzymes. Final Dx: acute tubular necrosis; chronic renal failure likely secondary to HIV nephropathy; HIV positive; COPD, thrombocytopenia; culture negative sepsis; hypotension; respiratory failure/hypoxia; alcoholism; tobacco abuse; seizures secondary to head trauma; depression; s/p LS operation; hypothyroidism; insomnia; and anxiety. 1/5/07 Received Death Certificate from funeral home which reveals COD as HIV/AIDS with rhabdomyalysis as a contributing factor.	Y	11/22/2006		Y	Y	4			N	11/14/2006	11/15/2006	1		UNK	UNK	UNKNOWN		BRAIN INJURY HIV REPORTED BY MOTHER NO KNOWN ALLERGIES			1						1	Asthenia; Blood pressure decreased; Dysphonia; Dyspnoea; Heart rate increased; Pallor; Pharyngolaryngeal pain; Pneumonia; Renal failure; Respiratory arrest; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601711~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Results in Death	Influenza
0268454	12/06/2006	GA	48.0	48		F	12/06/2006	WITHIN 1 HR OF RECEIVING THE FLULAVAL INJECTION, THE PATIENT STATED THAT SHE HAD A METALLIC TASTE IN HER MOUTH AND BEGAN FEELING HER LEFT ARM BEGIN TO SWELL. WITHIN 24 HOURS AFTER THE INJECTION, THE EPITROCHLEAR LYMPH NODES IN THE LEFT ARM BEGAN TO ENLARGE, BECAME PAINFUL AND HAD SUBCUTEANEOUS TISSUE SWELLING FROM THE LOWER MID ARM TO UPPER MID ARM. THE LYMPH NODES AND SUBCUTANEOUS TISSUE CONTINUED TO SWELL AND INCREASE IN SIZE AND PEAKED IN SIZE AFTER 6-7 DAYS AFTER THE INJECTION. RANGE OF MOTION TO THE LEFT ARM WAS ALSO LIMITED AND THE LYMPH NODES TO THE LEFT UNDERARM AREA WERE ALSO ENLARGED ABD PAINFUL. ON DAY 10, THE EPITROCHLEAR LYMPH NODES AND SUBCUTANEOUS TISSUE HAVE REDUCED SIGNIFICANTLY IN SIZE; ALTHOUGH, THE EPITROCHLEAR LYMPH NODE MEASURED 2 3/4 INCHES BY 1 3/4 INCHES. THE PATIENT ALSO EXPERIENCE MILD MYALGIA THROUGHOUT THIS PERIOD OF TIME.									U	11/27/2006	11/27/2006	0		UNK	UNK	BONIVA 150MG P.O.MONTHLY	NKA	NKA			1						1	Abdominal pain; Dysgeusia; Joint range of motion decreased; Lymph node pain; Lymphadenopathy; Myalgia; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F602211~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0268455	12/06/2006	NE	2.0	2	.8	M	12/06/2006	Seven hours after vaccine given patient become irritable and spiked fever to 102.2 and hallucinated worms all over the place.  Hallucinations lasted approximately 20 hours. Telephone report on 12/6 5pm: hallucinations resolved.  Spiked fever in late afternoon.				Y					Y	12/04/2006			rapid strep negative	UNK	UNK	none	mild congestion without systemic symtoms	viral exanthem on 10/12/2006 reactive airway disease 33 week twin			1						1	Hallucination; Irritability; Pyrexia	FLU3~SANOFI PASTEUR~U2196AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268456	12/06/2006	SD	0.0	73		F	12/06/2006	11/13/06  REPORTED INJECTION SITE SORE, PAINFUL, AND RED   AUGMENTIN 875 BID X 7 DAYS.										11/10/2006	11/13/2006	3		UNK	UNK	PREVACID, ASA, ACCUPRIL, ZOCOR, MIRALAX					1						1	Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U2286AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0985F~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268458	12/06/2006	MD	31.0			F	12/06/2006	4 days after receiving Fluogen employee starting getting fine erythemic rash on anterior and lateral aspects of thighs and lower back/c/o itchiness but no other sx.									Y					UNK	UNK	Progesterone only oral contraceptive	none	Stable asthma/rxed with Advair			1						1	Pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~U2260AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268460	12/06/2006	TN	29.0	29		F	12/06/2006	Broke out with severe urticartia/hives over entire body the same night as vaccine. The hives have lasted the past 3 weeks and arent getting any better. I am being treated with antihistimines/prednizone/lotion daily.				Y						11/08/2006	11/08/2006	0		UNK	UNK	none	none	none			1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70740~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0268466	12/06/2006	IN		47		M	12/06/2006	On 11/28 patient contacted doctor and later visited the office. Diagnosed with Bell's Palsy affecting left side of face. Patient has history of head trauma so uncertain whether vaccine caused problem.				Y					U	11/22/2006	11/28/2006	6		PVT	PUB	Vicodin	Bilateral elbow pain, loose stools	Hep C, alcoholism, drug abuse, head trauma, urticarial rash.			1						1	Facial palsy	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71646~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0268467	12/06/2006	NC	24.0	23		F	12/06/2006	Persisting muscle pain at left deltoid S/P flu shot approximately 3 weeks ago.				Y					Y	11/15/2006	11/15/2006	0		OTH	PUB			Sodium Naproxen			1						1	Injection site reaction; Myalgia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71646~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0268468	12/06/2006	NY	41.0	41		F	12/06/2006	Pt states she had low grade fever, achiness approx 8 hrs after vaccine. Next pm experienced 103.6 fever, tachycardia and generalized aches. On 12/02 pt woke up vomiting, T of 102.5 still achiness. Arm red and swollen. 12/03 no fever, continued severe malaise, Today 12/10 pt has no fever, aches, arm slightly red some swelling.									Y	11/30/2006	11/30/2006	0		PVT	PVT	NONE					1						1	Injection site erythema; Injection site oedema; Malaise; Pain; Pyrexia; Tachycardia; Vomiting	FLU3~EVANS VACCINES~U2239AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|MNQ~SANOFI PASTEUR~U2154CA~UNK~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PPV~MERCK & CO. INC.~0988F~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268462	12/07/2006	CA	4.0	4		M	12/06/2006	Vaccinated 11/17 with Influenza vaccine at time pt had temp of 101 orally, other symptoms not known. But fever resolved on 12/01/06, pt developed fever, headache, vomiting. Taken to hospital where LP C/W viral meningitis on 12/02/06 and admitted. Recovered in 1-2 days and discharged on 12/04/2006.  1/22/07 Received medical records from hospital which reveal patient admitted 12/2-12/4/06 for headache, fever & vomiting.  Treated w/antibiotics until CSF c/s neg for 48 hrs.  - FINAL DX: Meningitis, likely viral etiology.					Y	2			Y	11/17/2006	12/01/2006	14	LABS: CSF showed 105 WBC, glucose 34, protein 80.	PUB	PUB	NONE	Fever of 101.1				1						1	Headache; Meningitis; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2252AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0268463	12/07/2006	HI	4.0	4		F	12/06/2006	Erythema and swelling of upper arm/shoulder, pain with arm raising.				Y					Y	12/04/2006	12/05/2006	1		MIL	MIL	Zyrtec	NONE	Season allergic rhinitis, Asthma			1						1	Hypokinesia; Injection site erythema; Injection site oedema; Pain	FLU3~SANOFI PASTEUR~U2259AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268477	12/07/2006	OH	89.0	89		M	12/03/2006	Reported death due to Guillain Barre Syndrome. Transferred to Hospital on 11/18/06 with severe pain to spinal stenosis, low grade fever, and possible Guillian Barre Syndrome. Dies at hospital. 1/8/07 Received medical records from hospital which reveal patient admitted 11/18/06-11/29/06 for LE pain with ascending paralysis & studies positive for GBS.  Treated with IVIG x 4 days. on 11/25, had PEA & coded.  Responded well initially then coded several additional times before expiring on 11/29. Consults of pulmonology & neurology included.  D/C summary indicates COD as secondary to GBS, causing severe autonomic dysfunction & cardiac arrhythmias. PMH: CHF LABS: EMG/NCS 11/20/06, c/w GBS; CT of head 11/18, showed mild atrophy; fluoroscopic LP on 11/18, revealed elevated protein, normal WBC & RBC. FINAL Dx: Guillain Barre Syndrome; CHF w/ejection fraction of 35%; aspiration pneumonia; BPH; anemia; & CAD. 1/9/07 Received copy of Death Certificate from family which reveals COD as GBS with contributing factors of CAD & spinal stenosis.	Y	11/29/2006			Y				N	11/07/2006			EMG and Spinal tap confirmed DX according to MD.	PUB	PVT	As of 5/1/06 over	Spinal stenosis, lubo sacral neuritis.	Spinal stenosis, lubo sacral neuritis, CHF, Aortic stenosis, Gilberts syndrome, aortic regurgitation, BPH, osteoarthritis, anemia, renal insuffiency.			1						1	Back pain; Guillain-Barre syndrome; Laboratory test abnormal; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2250AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0268484	12/07/2006	AK	19.0	19		M	11/30/2006	Severe total body pain, fever for 102.7, vomiting, nausea, headache. Got sick at 930 PM; shots about 230PM. Red arm at injection site.				Y					U	11/28/2006	11/28/2006	0	He went back to clinic for care.	OTH	OTH		NONE	NONE		AK200679	1						1	Headache; Injection site erythema; Nausea; Pain; Pyrexia; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA231AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1008P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0268486	12/07/2006	MT	77.0	77		F	12/04/2006	Onset pain at injection site 24 hours after injection. Continued to increase over next 2 weeks, continues at time of report but improving only slightly. PMD contacted today.									U	11/09/2006	11/10/2006	1	NONE	OTH	PVT	Zocor; Enalapril; Librium; Levothroid	NONE	Enlarged heart only slightly			1						1	Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69899~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268490	12/07/2006	WV	62.0	62		M	11/30/2006	Severe headache in PM (two days/nights).									Y	11/27/2006	11/28/2006	1		PUB	PUB		NONE	NONE			1						1	Headache	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F602111~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268491	12/07/2006	TX	4.0	4		M		Rash on the site of impaction and erythematosis maculopapular rashes all over the body. responded to antihistamine. Resolved after 3 days.									Y	11/14/2006	11/15/2006	1	NONE	PVT	PVT		NONE	Asthma - controlled.			1						1	Injection site rash; Rash erythematous; Rash maculo-papular	FLU3~SANOFI PASTEUR~U2241AA~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0552R~2~~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0268493	12/07/2006	WA	1.06	1	.1	F	11/30/2006	Fever would come then go away then come back. I also noted some red spots on her face, runny nose. When sleeping would wake up all sweaty.				Y					Y	11/20/2006	11/28/2006	8		PVT	PUB	NONE	NONE	Microtia right ear - no canal			1						1	Hyperhidrosis; Pyrexia; Rash maculo-papular; Rhinorrhoea	FLU3~SANOFI PASTEUR~U2219AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0952F~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0245F~1~~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0268497	12/07/2006	IL	76.0	76		F	12/04/2006	Next day, I began to itch all over and had bumps all over. Thought maybe was flea bites but when I saw the doctor, said was hives. Gave Zyrtec and cleared up.									Y	10/19/2006	10/21/2006	2		PVT	OTH	Crestor; Atenolol; Amitiza; Xifaxan; Triam; HCTZ	NONE				1						1	Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0268498	12/07/2006	MA	69.0	69		M		Case had flu shot AM, pneumovax SQ left arm at public flu clinic 11/15/06. Noted soreness at site in evening. 11-16-06 increased redness, soreness, swelling-called Board of Health-told to consult medical doctor. Compress to site, TYELNOL as needed. 11-17-06 seen in ER IV treatment. 11-18-06 ER visit IV treatment and oral antibiotics for 5 days. 11/21/06 case feeling better-less redness/inflammation.				Y					Y	11/15/2006	11/15/2006	0		PUB	PUB	LIPITOR; Atenolol	NONE	High blood pressure			1						1	Cellulitis; Erythema; Myalgia; Swelling	FLU3~SANOFI PASTEUR~U2279AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577R~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0268499	12/07/2006	MA	66.0	66		F	11/22/2006	11/15/06 Case received flu/PNEUMOVAX shot at public clinic. 11/17/06 Right arm sore, area of site red, hot to touch, fever 102, seen in ER and given Prednisone for 3 days, antibiotic for 10 days. Dx Cellulitis. Advised to put compress on site. 11/22/06 Case reported to 30 hours in person - states arm was much better.				Y					Y	11/15/2006	11/17/2006	2		PUB	PUB	FOSAMAX; ZOCOR; TRICOR	NONE	NONE			1						1	Cellulitis; Injection site erythema; Injection site pain; Injection site reaction; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U2279AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577R~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0268512	12/07/2006	MI	24.0	24		F	12/06/2006	Vaccines 11/30/06. 12/01/06 rt arm appeared bruised, 12/02/06 inflamed. Getting flu sx temp 101, chills, HA severe, 12/02/06. Gave her VI antibiotics home on Keflex. 12/03/06 redness moved to elbow, itchy, burning, temp 101, more IV antibiotics at ER . Put on Clindamycin. 12/04/2006 fever 99. Little more redness about level of elbow. 12/05/06 back to ER and kept overnight with more IV antibiotics. Home back on Keflex. Took Clindamycin x 1.5 days Ibuprofen. 12/06/06 Home today, less redness, still itching and burning fever gone, DX cellulitis. Had flu vaccine before, chicken pos vaccine usual reaction, not unusual.  12/8/06 T/C to provider revealed TDaP given in left arm, flu & pneumo in right arm.  2/2/07 Received medical records from hospital which reveal patient experienced right upper arm pain, swelling, warmth & redness at pneumovax site.  Seen in ER on 12/2 for flu like symptoms & stiff neck/HA.  Tx w/IV antibiotics & d/c to home on oral antibiotics.  Returned to ER on 12/3 for spreading cellulitis of right arm, fever & cough w/green sputum since vax.  Received additional IV antibiotics & admit recommended but pt declined, preferred to return to ER daily for checks.  Returned to ER on 12/5 & was admitted overnight this time with right arm cellulitis, failed outpatient treatment.  Improved significantly on IV antibiotics & was d/c home on continued oral antibiotics. FINAL DX: Cellulitis right arm s/p pneumovax.				Y	Y	1			Y	11/30/2006	12/01/2006	1	LABS: LP done 12/2 revealed glucose & protein.  12/2 WBC 13.6.  12/2 Blood c/s neg.  12/3 WBC 10.4.  12/5 WBC 4.6.	PUB	UNK			Tendency to have a lot of sinus infections and migraines.  PMH: chronic migraine headaches			1						1	Cellulitis; Chills; Contusion; Headache; Influenza like illness; Injection site erythema; Injection site inflammation; Pruritus; Pyrexia; Skin burning sensation	FLU3~SANOFI PASTEUR~U2178AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0883F~1~SC~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2609AA~1~IM~LA~TDAP (ADACEL)~1	USA	Hospitalisation	Influenza
0268514	12/07/2006	GA	48.0	48		F	12/07/2006	Fever 102 F about 12 hours later.									Y	12/05/2006	12/06/2006	1	NONE	PVT	PVT		NONE	Sulfa allergy			1						1	Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA231BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268515	12/07/2006	KS	0.55	0	.6	M	12/06/2006	Patient was given 1ml of flu vaccine. Had an injection set up for his sister of 0.5ml. Instead of giving Comvax, I grabbed the other flu vaccine. Mom told of error. Mom was also told by staff officer and CDC that the site might become a lot more red and check fever. Call if any questions or problems.									Y	12/06/2006			NONE	PUB	PUB		NONE	NONE			1						1	Medication error	FLU3~SANOFI PASTEUR~U2212AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0679F~4~~LL~HIB + HEP B (COMVAX)~1|HEPA~MERCK & CO. INC.~0144F~2~~RL~HEP A (VAQTA)~1	USA		Influenza
0268516	12/07/2006	MD	62.0	62		F	12/07/2006	Pt developed hives about 1 hour after vaccine on 12/05/06. Hives on face, arms, neck, chest and back. Resolved in 24-48 hours. Treated with Benadryl cream. Received flu vaccine many times previously, no problem. Pt has history of eczema and rhinitis.									Y	12/05/2006	12/05/2006	0	NONE	PUB	PUB	Elavil cream; Fosamax	Eczema	Eczema; Rhinitis			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2284AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268517	12/07/2006	NC	1.05	1	.1	F	12/06/2006	Right upper thigh with redness and swelling. Dx with cellulitis. Bactraban TID, Duricef 500/5ml, 1 tsp BID for 10 days. Cold compress 2 times for 1 day.									U	12/04/2006	12/05/2006	1	NONE	PUB	PUB	Albuterol PRN	Bronchitis	NONE			1						1	Cellulitis; Erythema; Swelling	DTAP~SANOFI PASTEUR~U1751CA~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT2176CA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0279F~3~IM~RL~HIB (PEDVAXHIB)~1|MMRV~MERCK & CO. INC.~1261F~1~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08691A~4~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0268520	12/07/2006	MA	45.0	45		F	12/07/2006	Fever, chills, sweating, headache, fatigue.									Y	12/05/2006	12/05/2006	0		UNK	UNK		No	Possible Asthma			1						1	Chills; Fatigue; Headache; Hyperhidrosis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0268521	12/07/2006	OH	65.0	64		F	12/02/2006	My mother collapsed in the dr office about 10 seconds after the flu shot and went into cardiac arrest. She is currently in ICU. 01/22/07-records received and reviewed. DC DX for DOS 12/02-12/16/06- Acute witnessed cardiopulmonary arrest with resuscitation Ventricular fibrillation Acute respiratory failure Anoxic encephalopathy Prior history of intracerebral hemorrhage, status post aneurismal surgery Methicillin resistant Staphylococcus aureus pneumonia Hypokalemia Cardiomyopathy. HX: Became syncopal and collapsed in physician's office after receipt of flu vaccine. She immediately came to and was aware of her surrounding. Ambulated to car, as son was driving out of parking lot, patient had a sudden cardiac arrest.. Found to be in ventricular fibrillation and after 4 cardioversions procedures converted into a slow sinus rhythm. Seen in ER required intubation and dopamine drip and dobutamine.  PMH: MVA in 1998 in which she experienced a myocardial infarction. CVA followed with a balance disorder. Cerebral aneurysm which was repaired. CHF with an ejection fraction of 35% in 2003. After CVA and aneurysm repair the patient had decrease in peripheral vision and peripheral neuropathy, dysphagia and hyperlipidemia. PE: Did not respond to verbal or painful commands, eye movement was random, at times seemed to have purposeful eye movement but would not move her extremities or reposition her body.  Remained obtunded. Ventilator and life support withdrawn. Hospice management. Comfort measures. Transferred to hospice unit. Spoke with hospice unit, patient expired on 12/17/06.  1/25/07 Received Death Certificate which reveals COD as anoxic encephalopathy, cardiopulmonary arrest & CAD.	Y	12/17/2006	Y	Y	Y	14			N	12/02/2006	12/02/2006	0	MRSA from sputum culture. CXR: cardiomegaly with interstitial edema.  CT of head no evidence of acute cortical bleeding. Subsequent CT showering of emboli into the posterior circulation and cerebellar area were noted.  EKG: wide QRS complex, left bundle branch block.  EEG:record is abnormal and demonstrates generalized disturbances of cerebral functioning manifested by slowing of the background and is compatible with metabolic encephalopathy or other cause of diffuse neural dysfunction.	UNK	UNK	Several	N/A	Prior history of intracerebral hemorrhage, status post aneurismal surgery  PMH: MVA in 1998 in which she experienced a myocardial infarction. CVA followed with a balance disorder. Cerebral aneurysm which was repaired. CHF with an ejection fraction of 35% in 2003. After CVA and aneurysm repair the patient had decrease in peripheral vision and peripheral neuropathy, dysphagia and hyperlipidemia.			1						1	Cardiac arrest; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0268522	12/07/2006	ID	70.0	70		M	12/07/2006	Three hours after pneumonia immunization, patient developed a raised, erythematous, woody, painful, 4 inch by 6 inch swelling at injection site.				Y					Y	11/17/2006	11/17/2006	0		UNK	UNK	none	none	none			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0087F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0268523	12/07/2006	NC	65.0	65		F	12/07/2006	Started on 11/14 with feet tingling. Has progressed to need for ventillator support. Family questions flu or pneumovax vaccination. Consultation report DX: GUILLIAN-BARRE syndrome Respiratory failure urinary tract infection Encephalopathy Hypertension Questionable history of deep venous thrombosis History of hiatal hernia/dyspepsia Dyslipidemia. One week prior to admission in usual state of health developed severe pain in bottom of her feet up into pelvic bone. Negative CT scan. Increased pain in hands cannot life her arms. On admission tingling in feet. Tongue and lips numb.  11/21/06 pulmonary consult: now on day 4 0f 5 IV IG. Progressive respiratory decline, insufficiency with falling negative inspiratory force. HTN.   DC with instruction to take motrin, FLEXERIL and PERCOCET. and 11/18/06 DX numbness in hands/arms. weakness. DC home. Discharged to rehab Facility. Off ventilator and had finger flexion and other movement.				Y	Y	20	Y		Y	11/07/2006	11/14/2006	7		UNK	UNK		Unknown	Hypercholesterolemia Arthritis none rheumatoid GERD			1						1	Asthenia; Blood product transfusion; Computerised tomogram normal; Encephalopathy; Guillain-Barre syndrome; Hypertension; Hypoaesthesia; Hypoaesthesia oral; Inspiratory capacity decreased; Mobility decreased; Pain in extremity; Paraesthesia; Pelvic pain; Respiratory failure; Urinary tract infection	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F600411~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0486F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0268524	12/07/2006	TX	0.3			M	12/07/2006	GIVEN PRESERVATIVE FREE FLU SHOT TO 4 MONTH CHILD.									Y					UNK	UNK						1						1	Medication error	FLU3~SANOFI PASTEUR~U2191CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268525	12/07/2006	CA	57.0	57		F	12/07/2006	Within 24 hours of receiving influenza vaccination reported rash and itching of arms, head, waist, upper legs, and hands.									Y	11/16/2006			none	UNK	UNK	Interferon		Multiple Sclerosis 2003			1						1	Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua213ba~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268526	12/07/2006	CA	53.0	53		F	12/07/2006	On 12/6/06, Employee reported that approximately 2 hours post vaccination, developed cold-like symptoms to include coughing, scratchy throat, sinus headaches.  Denied fever or chills.  Symptoms worsened since initial report on 12/06/06. Referred for further follow-up.				Y					N	12/05/2006	12/05/2006	0	Not applicable	UNK	UNK	Amoxicillin -1 dose on 12/1/06	None	H/o Sarcoidosis--not active			1						1	Cluster headache; Cough; Pharyngitis; Pharyngolaryngeal pain; Rhinitis	FLU3~SANOFI PASTEUR~U2218AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268527	12/07/2006	CA	4.0	6		M	12/07/2006	Swollen left proximal medidal leg.				Y					Y	11/28/2006	11/28/2006	0		UNK	UNK		Swollen left proximal medial leg				1						1	Swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC21B056AA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2272AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB130AA~1~IM~RL~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~Y1030~4~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0830F~3~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0268528	12/07/2006	VA	57.0	57		F	12/07/2006	Received influenza vaccine L shoulder on 10/30/06.  Within 20 minutes the upper L arms ached and throbbed intensely.  Pain began to subside after 4 hours but for next weeks had limited range of motion in L arm.  Whenever trying to lift arm expecially when reaching to the right and then lifting or in an abduction motion.  Began heat treaments after 4 weeks of limited mobility.  Treatments helped to relieve symptoms over the next 2 weeks.									Y	10/30/2006	10/30/2006	0		UNK	UNK	Prilosec, Claritin, Chondrotin-Glucosamine, Flaxseed oil, Multi Vitamin, Aleve (1 daily), Lamasil,dyazide	None	None			1						1	Injection site pain; Joint range of motion decreased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71826~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268529	12/07/2006	MI	64.0	64		F	12/07/2006	Nurse administered 1cc of flu vaccine IM.									Y	11/13/2006	11/13/2006	0	None	MIL	PVT	Unknown	No	Unknown			1						1	Medication error	FLU3~SANOFI PASTEUR~U2256AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268531	12/07/2006	MI	54.0	54		F	12/07/2006	Nurse administered 1 cc of inactivated flu vaccine.  No adverse effects reported.									Y	11/13/2006	11/13/2006	0	None	UNK	UNK	Unknown	No	Unknown			1						1	Medication error	FLU3~SANOFI PASTEUR~U2256AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268532	12/07/2006	MI	34.0	34		M	12/07/2006	Nurse administered 1 cc of inactivated flu vaccine.  No adverse effects reported.									Y	11/13/2006	11/13/2006	0	None	UNK	UNK	Unknown	No	Unknown			1						1	Medication error	FLU3~SANOFI PASTEUR~U2256AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268533	12/07/2006	MI	45.0	45		F	12/07/2006	Nurse administered 1cc of inactivated flu vaccine. No adverse effects reported.									Y	11/13/2006	11/13/2006	0		UNK	UNK	Unknown	No	Unknown			1						1	Medication error	FLU3~SANOFI PASTEUR~U2256AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268534	12/07/2006	MI	54.0	54		M	12/07/2006	Nurse administered 1 cc of inactivated flu vaccine.  No adverse effects reported.									Y	11/13/2006	11/13/2006	0	None	UNK	UNK	Unknown	No	Unknown			1						1	Medication error	FLU3~SANOFI PASTEUR~U2256AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268535	12/07/2006	OH	21.0	21		M	12/07/2006	Presented to the ER approximately 14 days after vaccination with chest pain consistent with myopericarditis. 02/28/07-records received from facility for DOS 12/13-2/21/07. DX: acute myopericarditis. adverse effect of drug therapy vaccines small pox. Ventricular septal defect.				Y	Y	3			Y	11/04/2006	11/18/2006	14	Troponin = 1.9; non specific T wave changes CPK=290  MB=1.4 Labs 02/28/07:EKG non diagnostic T wave changes age vs. resolving pericardial inflammation. Echocardiogram: ventricular septal defect. Labs: WNL	MIL	MIL	none	none; px was a PRIMARY VACCINEE.  I DON'T KNOW HOW MANY PREVIOUS FLU AND TYPHOID VACCINES HE HAS HAD.	none			1						1	Chest pain; Pericarditis	FLUX~UNKNOWN MANUFACTURER~~1~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~1~~LA~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~~1~IM~UN~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0268537	12/07/2006	IL	68.0	68		F	12/07/2006	Vaccinated with Pneumovax, .5ml in the right deltoid on 11/09/2006.On 11/15/2006, contacted the health department: said she developed pain in the right arm and shoulder approximately one hour after being vaccinated. Unable to lift her arm by 11/15/2006. Seen by Dr. on 11/15/2006. Referred to a rehabilitaion specialist on 11/20/2006. Dr.  gave IM cortisone and Advil.				Y					U	11/09/2006	11/09/2006	0		UNK	UNK		none	none			1						1	Hypokinesia; Shoulder pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0618F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0268538	12/07/2006	CA	57.0	57		F	12/07/2006	Swelling and redness 10cm x 10 cm. Area hot to touch. Complained of headache and fever after vaccination and pain had radiated to the neck.  Onset of symptoms were later in the day after receiving vaccination.  She said pain was less severe today, but still has some pain.  Pain in the neck has stopped.  Ice was applied in clinic today.									U	12/05/2006	12/05/2006	0		UNK	UNK						1						1	Headache; Injection site erythema; Injection site swelling; Injection site warmth; Neck pain; Pyrexia	FLU3~SANOFI PASTEUR~U2272AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268539	12/07/2006	CA	5.0	5		M	12/07/2006	Patient received IPV, Infarix, MMRV-Proquad, Hepatitis B, and Influenza vaccines at 2:30 PM and had a rash at 6:00 PM.				Y					Y	12/07/2006	12/07/2006	0		UNK	UNK		history of ALL s/p chemo				1						1	Rash	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B035AA~1~IM~UN~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2193AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1031~4~SC~UN~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~1094F~1~SC~UN~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0268542	12/07/2006	MD	0.8	0	.8	F		Had high fever, dehydration 11/30/06, right middle lobe pneumonia, seen at hospital then transferred to another. Gave IV fluids, IV antibiotics. Discharged on 12/03/06. Had Fluzone 0.25ml on 11/28/06. Pt at that time had cough and runny nose, had temp of 97.5. Temp at office was 99. 12/14/06-records received and reviewed. DC DX: for DOS 12/1-12/3/06 Right lower lobe pneumonia HX: 2-3 days fever with cough and increased work to breath.					Y	3			Y	11/28/2006	11/30/2006	2		PVT	PUB	Tylenol	Cough, temperature 99.6				1						1	Cough; Dehydration; Dyspnoea; Pneumonia; Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~UT2244AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0268543	12/08/2006	CO	4.0	4		F	12/07/2006	Flu vaccine 11/28/2006. On 12/03/2006 experienced onset of Left thigh pain, limp, fever, increased WBC and CRP but ESR 24, f/u labs 12/4 revealed myositis, left rectus femoris, increase ESR to 82, required IV antibiotics, Cefazolin, and inpatient admission. 01/01/07-records received and reviewed. DC DX for DOS 12/5-12/7/06 DX: left rectus femorus myositis.				Y	Y	2			Y	11/28/2006	12/03/2006	5	WBC inc 19K, ESR inc to 82, CRP 77.7, blood cx neg, strep cx throat neg.  ESR increased from 24 to 82, CRP 7.3 MRI left rectus femorus myositis without abscess or osteomyelitis.  WBC ranged from 12.0-19.4.	PVT	PVT	NONE	Mild Rash				1						1	Hypotonia; Injection site pain; Laboratory test abnormal; Myositis; Pyrexia; Red blood cell sedimentation rate increased; White blood cell count increased; Gait disturbance; Injection site pain; Laboratory test abnormal; Myositis; Pyrexia; Red blood cell sedimentation rate increased; White blood cell count increased	FLU3~SANOFI PASTEUR~U2281AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0614R~1~IM~RL~HEP B (RECOMBIVAX HB)~1|FLU3~SANOFI PASTEUR~U2281AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|HEP~MERCK & CO. INC.~0614R~1~IM~RL~HEP B (RECOMBIVAX HB)~2	USA	Hospitalisation	Influenza
0268545	12/08/2006	CA	5.0	5		M	12/04/2006	Left arm red, swollen, itchy from shoulder to elbow.				Y					U	11/28/2006	11/30/2006	2		PVT	PUB		NONE				1						1	Injection site erythema; Injection site oedema; Pruritus	FLU3~SANOFI PASTEUR~U2237AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268546	12/08/2006	CA	4.0	4		F	12/07/2006	S/P shot no urticaria + eye swollen + wheals.									Y	12/07/2006	12/07/2006	0	NONE	PVT	PUB		NONE	NONE			1						1	Eye swelling; Urticaria	DTAP~SANOFI PASTEUR~C2649AA~5~~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2272AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y10312~4~~RA~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~0976F~1~~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0268547	12/08/2006	VA	46.0	46		M	11/30/2006	Patient had redness, swelling and painful to touch. (as noted pt stated left elbow swelling 6 hours after TD, seen 48 hours after by me with continued but decreased swelling, olecranon bursa, full range of motion, seen again 12/7/06 resolution of symptoms.									Y	11/28/2006	11/28/2006	0	CMP, CBC, ESR all normal.	MIL	MIL	BP Meds	NONE	NONE			1						1	Bursitis; Injection site erythema; Injection site oedema; Injection site pain; Oedema	FLUN3~MEDIMMUNE VACCINES, INC.~500430P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TD~AVENTIS PASTEUR~U1731DA~UNK~IM~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0268556	12/08/2006	IN	1.07	1	.1	M	12/07/2006	Pt comes into office 12/07/06. Left side of face and jaw swollen since this am. Pt received ProQuad and Hep A and 2nd flu shot on 11/17/06. DC Parotitis. Presumably 2 hours to  ProQuad.				Y					Y	11/17/2006	12/07/2006	20	NONE	PVT	PVT	NONE	NONE	Persistent milk intolerance.			1						1	Face oedema; Parotitis	FLU3~SANOFI PASTEUR~U2102AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0465F~1~IM~RL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~0201F~1~SC~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0268557	12/08/2006	MI	34.0	34		M	12/08/2006	Nurse administered 1 cc inactivated flu vaccine.  No adverse effects reported									Y	11/13/2006	11/13/2006	0	None	UNK	UNK	Unknown	No	Unknown			1						1	Medication error	FLU3~SANOFI PASTEUR~U2256AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268558	12/08/2006	MI	41.0	41		M	12/08/2006	Nurse administered 1 cc inactivated flu vaccine.  No adverse effects reported.									Y	11/13/2006	11/13/2006	0	None	UNK	UNK	Unknown	No	Unknown			1						1	Medication error	FLU3~SANOFI PASTEUR~U2256AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268559	12/08/2006	MI	53.0	53		F	12/08/2006	Nurse administered 1 cc inactivated flu vaccine.  No adverse effects reported.									Y	11/13/2006	11/13/2006	0	None	UNK	UNK	Unknown	No	Unknown			1						1	Medication error	FLU3~SANOFI PASTEUR~U2256AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268560	12/08/2006	MI	54.0	54		F	12/08/2006	Nurse administered 1 cc inactivated flu vaccine.  No adverse effects reported.									Y	11/13/2006	11/13/2006	0	None	UNK	UNK	Unknown	No	Unknown			1						1	Medication error	FLU3~SANOFI PASTEUR~U2256AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268561	12/08/2006	MI	55.0	55		F	12/08/2006	Nurse administered 1 cc of inactivated flu vaccine.  No adverse effects reported.									Y	11/13/2006	11/13/2006	0	None	UNK	UNK	Unknown	No	Unknown			1						1	Medication error	FLU3~SANOFI PASTEUR~U2213AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268562	12/08/2006	MI	54.0	54		F	12/08/2006	Nurse administered 1 cc inactivated flu vaccine.  No adverse effects reported.									Y	11/13/2006	11/13/2006	0	None	UNK	UNK	Unknown	No	Unknown			1						1	Medication error	FLU3~SANOFI PASTEUR~U2213AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268563	12/08/2006	MI	28.0	28		F	12/08/2006	Nurse administered 1 cc of inactivated flu vaccine.  No adverse effects reported.									Y	11/13/2006	11/13/2006	0	None	UNK	UNK	Unknown	No	Unknown			1						1	Medication error	FLU3~SANOFI PASTEUR~U2213AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268564	12/08/2006	MI	52.0	52		F	12/08/2006	Nurse administered 1 cc inactivated flu vaccine.  No adverse effects reported.									Y	11/13/2006	11/13/2006	0	None	UNK	UNK	Unknown	No	Unknown			1						1	Medication error	FLU3~SANOFI PASTEUR~U2213AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268565	12/08/2006	MI	48.0	48		M	12/08/2006	Nurse administered 1 cc inactivated flu vaccine.  No adverse effects reported.									Y	11/13/2006	11/13/2006	0	None	UNK	UNK	Unknown	No	Unknown			1						1	Medication error	FLU3~SANOFI PASTEUR~U2256AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268566	12/08/2006	MI	55.0	51		F	12/08/2006	Nurse administered 1 cc of inactivated flu vaccine.  No adverse effects reported.									Y	11/13/2006	11/13/2006	0	None	UNK	UNK	Unknown	No	Unknown			1						1	Medication error	FLU3~SANOFI PASTEUR~U2256AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268568	12/08/2006	PA	58.0	58		F	12/08/2006	I received the Flu Vaccine on 10/11/06 in the am at work. On the morning of 11/14/06 I awoke at 0530 and was very aware of hearing loss in my left ear. I went to my physician on 11/16/06 for an exam. She informed me I had fluid behind my ear drum. She ordered an antibiotic, Bactrim DS twice a day fro 7 days. And Musinex as needed. I did this with no relief or hearing return. Dr. then ordered a different antibiotic for 7 more days. Still no results. I was then sent to an E.N.T specialist was told I have sudden hearing loss due to a virus. My hearing loss was 45-50%. I was given an anti viral medication for 10 days and Prednisone 60mg for 10 days with instructions to call after a week if I did not notice an improvement. I did not. I then saw another E.N.T. specialist. He inseted a tube trough my ear drum and did 5 injections of steroids directly into the inner cannal, 4 days apart. I did not have any improvement. I also had an MRI on 11/27/06, to rule out tumors, this was unremarkable.				Y					N	10/11/2006	10/14/2006	3	Hearing tests (4) hearing loss of 45-50% left ear MRI- unremarkable	UNK	UNK	Atenolol 25mg daily Spiromalactone 50mg daily Trichor daily	None	High Blood Pressure Allergies- penicillin, Morphine, Codeine, Lipitor			1						1	Hearing impaired; Viral infection	FLU3~SANOFI PASTEUR~U2273AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268572	12/08/2006	WA	46.0	45		M	12/08/2006	Woke up at 1am the night of flu vaccine with sweats, fever, chills, headache, and feeling left arm, chest, shoulder feeling swollen.  Eyes crusty. Initially felt panicky, told himself to breathe slowly, and chest symptoms subsided.  He took Tylenol 650mg ii for HA.  He did not seek treatment, felt tired the next day, fine the day after.									Y	12/05/2005	12/06/2006	366		UNK	UNK	Rapamune5 mg/d; Prednisone5mg/d; Coumadin 7mg/d; Cellsept 750mg/d; Toprol 75mg/d; Lovastatin 20mg/d; Fosamax 70mg/d	None; Note that he is a high school teacher, and wife is an elementary school teacher: there has been a lot of illness that sounds just like this in the school staff.	Is a kidney transplant pt.  Currently healthy			1						1	Chills; Eye discharge; Fatigue; Headache; Hyperhidrosis; Panic reaction; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U2281AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268573	12/08/2006	WA	45.0	45		F	12/08/2006	Vomited 3 hours after receiving vaccine.  She woke up at 1am the night of vaccine with chills, fever, sweats.  She felt nauseous, distressed.  She resolved without treatment.  Note that husband who also received a vaccine was sick, see additional VAERS form completed today.									Y	12/05/2006	12/05/2006	0	none	UNK	UNK	none	No; however, there were 3 other staff at the school who said that they were ill from a virus that caused similar symptoms, prior to vaccine clinic.  They had come to work anyway.	none.			1						1	Chills; Hyperhidrosis; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2281AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268575	12/08/2006	TX	56.0	56		M	12/08/2006	Extreme fatigue, shortness of breath, pain aches and pains onset about 2 days after vaccination. Persisted for about 3 to 4 weeks until received Depo-Medrol injection at physician's office.  Now partially recovered, still some residual symptoms. Has gotten flu shots in the past, usually experiences minor aches and pains for short time.				Y					Y	11/14/2006	11/16/2006	2		UNK	UNK	Lasix, Spironolactone, Aceon	None	No known allergies			1						1	Dyspnoea; Fatigue; Pain	FLU3~SANOFI PASTEUR~U2212AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268577	12/08/2006	CA	75.0	75		M	12/08/2006	Patient had soreness of the left arm after receiving his injection at approximately 10:30 on 12/7/2006.  Over the next 3 hours he developed swelling and redness.  The pain was rather severe.  Symptoms started to improve this AM.  Today at 1100 am his left arm is red from edge of clavicle to just above the elbow with warmth and tenderness.  Advised tylenol and ice to the affected area, patient is advised against anti inflammatory medication for other medical reasons.									N	12/07/2006	12/07/2006	0	none	UNK	UNK	Lisinopril, HCTZ, Norvasc, Calcium, Vitamin D, Fosamax, Multi vitamin	none	htn, osteoporosis, kidney stones, Irritable bowel syndrome, BPH,Peyronie's Dz, mitral valve prolapse, cataracts			1						1	Erythema; Injection site pain; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F602111~7+~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0889F~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268579	12/08/2006	TX	4.0	4		M	12/08/2006	Patient received flu vaccine in right deltoid on 12/7/06 and returned to clinic on 12/8/06 with redness and swelling from right shoulder to right elbow.									U	12/07/2006	12/08/2006	1		UNK	UNK	none	none	none			1						1	Erythema; Swelling	FLU3~SANOFI PASTEUR~U2253AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268580	12/08/2006	CA	6.0	6		F	12/08/2006	Patient seen today due to mom's concern of swelling and redness at site 2 days post immunization and redness increasing in size, warm to touch, and pain when walking. Redness measures approximately 6x8 in in diameter on RVL. Patient dx with cellulitis and tx with ABX.									U	12/06/2006	12/07/2006	1		UNK	UNK						1						1	Cellulitis; Difficulty in walking; Injection site erythema; Injection site reaction; Injection site swelling; Injection site warmth; Pain	DTAP~SANOFI PASTEUR~U1615AA~5~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2249AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1009F~2~IM~LL~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~Y1031~4~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~1202F~2~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0268581	12/08/2006	AL	1.36	1	.4	F	12/08/2006	Fever, seizure activity. MR recived for a o/n ER admit for c/o fever and seizure activity. PE: WNL with notation of a painful mass in the right periauricular region with erythema and purulent discharge. Treated with anti-pyretics, Rocephin, and diet. Final DX: Viral illness, Febrile seizure.					Y				Y	12/05/2006	12/05/2006	0	Unremarkable. Labs and Diagnostics: UA/UC WNL, CMP with Glucose of 119, Na+ of 133, Globulin 2.2, Alk.P. 321, BUN/CREA. 27.5, Anion Gap 10.0, A/G Ratio 1.8 Omolal. 267. CBC reported as normal, not sent. CXR-WNL.	UNK	UNK	none	none	none			1						1	Convulsion; Pyrexia	FLU3~SANOFI PASTEUR~U2196AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB300AA~3~IM~LL~HEP B (ENGERIX-B)~1|HEPA~MERCK & CO. INC.~0511F~1~IM~LL~HEP A (VAQTA)~1|PNC~PFIZER\WYETH~B08640E~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1112R~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0268582	12/08/2006	AZ	22.0	22		F	12/08/2006	I received the vaccine in my upper arm at 8:30 a.m. on Wednesday, December 6th, as part of a flu shot clinic that was being offered to employees.  About 3 hours later, at 11:30 a.m., I was sitting at my desk working when my hands began to sweat and were cold, my heart began to race, I felt light-headed and thought I was going to faint.  I immediately headed over to the Student Health and Wellness center and told them I thought I was having an allergic reaction to the flu vaccine, which I had never had previously.  When I arrived my temperature was elevated, at about 99 degrees F, and my pulse was 130 beats per minute.  They took me in the back and my symptoms worsened.  I still felt very faint and dizzy, and was experiences waves of extreme nausea and extreme anxiety.  My hands were also still cold and sweating.  The health care workers weren't convinced that I was reacting to the flu shot, because my symptoms weren't typical of an allergic reaction.  They did a glucose test and a thyroid level test.  The glucose test came back immediately and was normal, the thyroid test came back normal the following day as well.  My symptoms worsened as I waited in the health center for about an hour and a half.  My throat then began to swell and my face became tingly.  The doctor then prescribed me an anti-histamine (Zyrtec 10mg) and my symptoms gradually lessened over the next hour and a quarter while they monitored me.  After I felt that my symptoms were under control I went home and slept for quite awhile as I was very tired.  My throat was still a little swollen for a couple hours afterward, but I didn't experience any other symptoms after the anti-histamine took effect.  My arm was sore for a couple days following the shot, but that has subsided as well.  It should be noted that there was no visible irritation at the site of injection at any point after my shot, however it was swollen and hard.				Y					Y	12/06/2006	12/06/2006	0	Glucose test-normal T3, T4 and TSH levels-normal	UNK	UNK	Levothroxine-150mg Apri-birth control pills	None	Hypothyroidism which is being treated with the synthroid.			1						1	Anxiety; Dizziness; Fatigue; Heart rate increased; Hyperhidrosis; Nausea; Paraesthesia; Peripheral coldness; Pharyngeal oedema; Pyrexia; Throat tightness	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0268583	12/08/2006	FL	33.0			M	12/08/2006	Immediate flu-like symptoms within 8 hrs, including severe runny nose, sneezing, muscle aching, and abdominal cramping/loose stool. I was perfectly healthy preceding. This is an unacceptable form of influenza vaccination, now being req'd by military. Claims of sometimes mild symptoms reported now seems false, as with most that take this mist. It is most likely just under-reported! As I am now sick, I strongly believe it is easily spread to family members, more contrary evidence to the manufacturer claim that should be investigated, especially for those of us with small children/pregnant spouse.									U					MIL	MIL	none	none	none			1						1	Abdominal pain; Diarrhoea; Influenza like illness; Myalgia; Rhinorrhoea; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~500433P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0268584	12/08/2006	CO	15.0	15		F	12/08/2006	Patient fainted and was unresponsive for 30 sec about 1-2 minutes after shot was given.									Y	12/08/2006	12/08/2006	0		UNK	UNK						1						1	Coma; Syncope	FLU3~SANOFI PASTEUR~u2255aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~c2556aa~1~IM~UN~TDAP (ADACEL)~1	USA		Influenza
0268600	12/08/2006	OH	78.0	78		F	12/08/2006	Cellulitis R arm within 24 hours of flu shot-hospitalized for IV antibiotics 1/29/07 Received medical records from hospital which reveal patient experienced pain, circumferential redness, swelling of the entire right arm w/limited elbow flexion s/p flu & pneumovax both received right arm.  Also had chest pain & was hypotensive on admit.  Afebrile on admit.  Developed a brief run of atrial fib.  Treated w/antibiotics & improved significantly. D/C to home w/continued oral antibiotics & to f/u w/PCP day after d/c.  FINAL DX: right arm cellulitis.					Y	2			Y	11/30/2006	11/30/2006	0	LABS: WBC 7.2.  All cultures neg.	PUB	PUB	ACTONEL, ARICEPT, DIOVAN, NORVASC, Aspirin		Osteoporosis, Alzheimer's dementia, hypertension, aortic sterosis.			1						1	Cellulitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72006~UNK~ID~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1128F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0268606	12/08/2006	MA	76.0			F	12/08/2006	Stated half of her arm red after flu vaccine, Fluzone given in left arm.														PUB	PUB						1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U2258AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268607	12/08/2006	GA	40.0			F	12/08/2006	3 hrs after administration began swelling and tender to touch, 6 hrs after admin started fever. 24 hrs after red and still tender.														PVT	PVT						1						1	Injection site erythema; Injection site oedema; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~U2271AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0620F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268608	12/08/2006	CA	55.0	55		F	12/07/2006	Pt states pain both arms after flu vax, TD, Pneumovax.									U	11/20/2006				PVT	UNK			Chronic Lumbar DJD, knee pain, depression.			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U2255AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0391F~1~~RA~PNEUMO (PNEUMOVAX)~1|TD~AVENTIS PASTEUR~U1907BA~UNK~~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0268609	12/08/2006	NC	36.0	36		M	12/08/2006	12/06/2006 pt complained of lingering pain at injection site to me on 12/06/06, injection given 11/15/06. Patient with discomfort at date 12/06/2006.									U	11/15/2006	11/15/2006	0		OTH	PVT	UNK	NONE	NONE			1						1	Discomfort; Injection site pain	FLU3~SANOFI PASTEUR~U2280AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268610	12/08/2006	IN	80.0	80		F	12/08/2006	Pt reported that she developed hives the next morning following taking the flu vaccine. Talked to her physician was told to take Benadryl, which she did. Condition improved.									Y	11/16/2006	11/17/2006	1		PUB	PUB	Synthroid		Thyroid cancer in 06/06, Shingles in 07/06.			1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72005~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268611	12/08/2006	GA	35.0	35		F	12/06/2006	Pt reports after shot. Reports unable to lift arm overhead and swollen that night. By next day same symptoms, but redness. Resolving some on Sunday. PT called Monday to report. Also rashy to lower area of extremity. Pt called PMD, no tx needed. Pt was not seen by doctor, only phone conversation. Pt instructed to use warm compresses and Tylenol if needed. Pt reported vomiting 12/06/06.									Y	12/01/2006	12/01/2006	0		PUB	PVT		NONE	NONE			1						1	Hypokinesia; Injection site erythema; Injection site oedema; Joint range of motion decreased; Rash; Vomiting	FLU3~SANOFI PASTEUR~U2284AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0601F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268048	12/09/2006	MI	21.0	21		M	12/09/2006	Syptoms developed about 20 minutes after receiving flu vaccine.  Initial complaints were dizziness, lightheadedness, gray vision, spots in his field of vision.  HR was 120 bpm; respirations 6 per minute.  An ambulance was called and took him to the ER for examination.  Benadryl seemed to relieve symptoms and he was sent home.  Twenty-four hours later, developed leg weakness and fatigue.  He saw his primary physician on Friday, December 1. He suggested the problem might be Guillian Barre Syndrome, although his symptoms were atypical of GBS.  A call was made to the Nurse also advised the possiblility of GBS, even with atypical symptoms.  Because of his worsening symptoms (greater weakness, leg pain, difficulty walking and loss of sensation in hands) an ER visit resulted in an admission to the hospital from Sunday evening until Tuesday mornig (Dec 3-Dec 5).  The staff neurologists ruled out GBS due to normal findings with MRI, LP and neuro exam.  The neurological symptoms, though, remained.  He saw his own neurologist On Wednesday, December 6. She has not ruled out GBS. She performed an EMG on Thursday, Dec 7, results were equivical. She continues to keep a close eye on him with with weekly office visits at the present time. She also advised he have at least one family member with him at all times, ordered an EPI pen and a peak flow meter.  He returned to the ER on Wednesday, December 6th with a severe spinal headache.  He has an appointment for a blood patch on Monday, December 11.  1/30/07 Received medical records from PCP which reveal on day of vax patient had ingrown toenail & eczema.  On way home, had dizziness, flushing & lightheadedness.  EMS called & taken to ER.  Tx w/Benadryl & IVF & responded well.  D/C to home.  Continued to have muscle soreness & complained of heavy legs.  Seen in office 12/1 & exam revealed mild weakness in legs but reflexes were present.  Dx w/reaction to flu shot.  PCP called neuro & discussed case & felt it was not GBS.  Had f/u neuro appt on 12/4 but went to ER on 12/3 & was admitted 12/3-12/5/06.  Seen by neuro on 12/6 w/continued weakness & HA when gets up.  Neuro dx early GBS & EMG ordered for 12/7. 1/30/07 Received medical records from hospital which reveal: 11/29/06 Seen in ER for dizziness, flushing, weakness & lightheadedness.  Received IV Benadryl & IVF.  Responded well & d/c to home. FINAL DX: allergic drug reaction to flu shot. 12/3/06-12/5/06 Admitted to hospital for ascending weakness for approx 1 wk.  Also had rash & hives after eating eggs on day of admit.  Admitted for neuro eval & w/u. Had vasovagal reaction after LP done.  Neuro eval was WNL.  Tx w/steroids & Benadryl.  D/C to home for further neuro & psych w/u as outpatient.  FINAL DX: Vasovagal episode. 12/6/06 Seen again in ER for continued complaints of HA, weakness, numbness & tingling in legs & nausea/vomiting.  Seen by 2nd opinion neuro that AM who dx possible early GBS.  T/C to neuro & was to see 12/7 as outpatient. D/C to home. FINAL DX: weakness & s/p LP headache.				Y	Y	2			U	11/29/2006	11/29/2006	0	LABS: WBC 17.8, monos 1.2, baso 0.5, lymph 4.1, polys 11.9 LABS: 12/1 -- WBC 8.9 LABS: cspine x ray neg.  MRI of brain neg.  Labs all WNL.  LP done, glucose 5 & protein 31, was WNL. Cultures neg.	UNK	UNK	Concerta Paxil Provigil Regalan Compazine	Infected in-grown toe nails.	Penicillin PMH: migraine HA, depression, ADHD & narcolepsy.			1						2	Arthralgia; Asthenia; Blood glucose normal; Decreased activity; Dizziness; Feeling hot; Hypersensitivity; Impaired work ability; Insomnia; Nuclear magnetic resonance imaging; Pain; Respiratory depression; Dizziness; Fatigue; Heart rate increased; Muscular weakness; Respiratory rate decreased; Visual disturbance	FLU3~SANOFI PASTEUR~U2260AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~U2260AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Hospitalisation	Influenza
0268585	12/09/2006	NC	53.0	53		F	12/09/2006	Patient c/o fast heart rate since receiving flu shot.  Also c/o some dizziness.  Evaluated in ER and seen by PCP.				Y					U	11/27/2006	11/27/2006	0	unknown	UNK	UNK	None	None	None			1						1	Dizziness; Heart rate increased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA221AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0268591	12/11/2006	MN	30.0	30		F	12/11/2006	Arm pain, gradually increasing from day the shot was given.  One day after shot, a lump formed under skin that gradually got larger as days passed.  Larget is was was 3/4 size of ping pong ball.  Area was black, blue, green and very sensitive to touch almost immediately.  Also caused flu like symptoms approximately 12 hours after shot was administered.  Infection grew worse over next few days and sought out medical treatment 7 days after shot was given.  Was given Diclocil antibiotics.  By this time the arm was very sore to move, hot to the touch and getting worse by the hour.  It also caused slow and increasing swelling of my entire body from day one of the shot.  At one point, The area was so bad, it looked as if someone had taken a mellon ball scooper and scooped out all the tissue around the sizeable lump right down to the bone.  By this time, the rest of my arm had begun to swell to the point of making my fingers numb and I thought I was in danger of serious blood infection or arm amputation. I sought medical attention 7 days after the shot was given, I was overseas and had to go to hospital there. I was advised that this was a very serious infection and I was not to leave the Bangkok area for at least 12 days to make sure the infection was under control.  During the time after the shot was given, sweats and chills were prominent, and fever up to 101.3 were detected, with other fevers hovering at 100.00.  The swelling of my whole body progressed with time.  After I started the antibiotics, the swelling subsided about 20% and the lump gradually diminished to about 1/3 the largest size it had been.  After 7 days of anti-biotics, the infection came back rapidly, within 12 hours of the last pill, and developed rapidly. Over the course of 3 hours the arm had swollen significantly and the lump tripled in size and the discoloration began to return.  Two days after ending the first round of antibiotics, I saw urgent care at home. I was advised to take augmentin for 10 days and if it did not improve within the first three days of treatment, to go to the ER to have it drained and get stronger drugs.  So far, the augmentin has made the swelling go down, the lump has diminished but is not gone, and the over all sick feeling has subsided to some degree.  The color is improving but you can still see the marks from the worst it had been.  This has been a very scary infection for me.  It does not want to seem to go away.  I am resting and drinking fluids and eating easily digestible foods, although my appetite is zero.				Y					N	11/20/2006	11/20/2006	0	Had WBC that registered 6.6, within normal limits approximately 2 weeks after the shot was administered. At the same time a temp of 99.6 was detected.	UNK	UNK	Xanax XR, Xananx, synthroid, remeron,flexeril, morphine, tramadol,more taken as needed.	Chronic Fatigue Syndrome, Fibromyalgia, Irritable Bowel Syndrome, Endometriosis, Bone spurs in Cervical spine	Chronic Fatigue syndrome, Fibromyalgia, Endometriosis, Irritable Bowel Syndrome, Bone spurs in Cervical spine, Panic disorder			1						1	Decreased appetite; Hypoaesthesia; Influenza like illness; Injection site warmth; Pain; Pyrexia; Skin discolouration; Skin hypertrophy; Swelling	FLUX~UNKNOWN MANUFACTURER~~1~ID~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~LA~PNEUMO (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~2~IM~LA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0268599	12/11/2006		5.0	4		M		A consumer report was received on 29 Nov 2006 concerning a 5 year old male vaccinee. No details concerning the vaccinees past medical history or concomitant medications were provided. On 05 Nov 2005 the vaccinee received an influenza vaccine. Approximately 1-2 weeks later the vaccinee developed sores on his feet, then lumps on the joints of his toes. This then progressed to warty sores on his hands then the joints of his fingers. The condition progressed and the vaccinee developed muscle involvement. The events were diagnosed as dermatomyositis. The events are ongoing and the vacinee is currently being treated with Prednisone. Further information is requested.									N	11/05/2005				UNK	UNK	Concomitant drugs not reported				CVOX200600702	1						1	Arthropathy; Dermatomyositis; Myasthenic syndrome; Skin disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0268602	12/11/2006	OK	4.0	3		M	12/08/2006	DTAP, MMR, Influenza given on 11-29-2006 started small red area on right thigh this am, now enlarged. No fever, or chills just itches on this evening. Ice pack to arm pain. Benadryl 12.5 mgs/5mls/5 ml take 5 ml PO four times a day as needed.									Y	11/27/2006	11/29/2006	2		PUB	OTH			Eczema, scratches			1						1	Erythema	DTAP~SANOFI PASTEUR~C2650AA~5~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2201AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0538F~2~SC~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA		Influenza
0268603	12/11/2006	OK	29.0	29		F	12/08/2006	Redden area at the site. No fever, no treatment.									Y	12/06/2006	12/07/2006	1		PUB	OTH						1						1	Erythema	FLU3~SANOFI PASTEUR~U2279AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268604	12/11/2006	MN		67		M	11/20/2006	Itching in legs, and abdomen.									Y	11/17/2006	11/18/2006	1	NONE	PVT	UNK		NONE	NKDA, COPD severe			1						1	Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72006~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268630	12/11/2006	MD	65.0	65		M	12/04/2006	10/27/06 received immunization. onset 11/05 of numbness and tingling in hands and feet. Hospitalized 11\8. No hosp docum of parasthesias. Readmitted 11/27 with numbness and tingling. Received testing and neuro consult. Pt stated r/o Guillian Barre. Continues to have problems. 12/27/06-records received and reviewed for DOS 11/27-11/30/06 DC DX: Peripheral neuropathy possible due to flu shot Prostate cancer borderline dyslipidemia EMG:nerve conduction and late response studies are consistent with peripheral neuropathy, mild to moderately severe, predominately sensory type with mixed features of axonal loss and demyelination.  PMH: cancer of prostate, status post irradiation treatment, 2 laminectomies and cholecystectomy.					Y	5			U	10/27/2006	11/02/2006	6	LP: did not reveal GBS, lymph 100, mono, 0, RBC 3	PUB	PVT	UNK		Prostate Cancer 06, Cholecystectomy, 1/06 PMH:  status post irradiation treatment, 2 laminectomies.			1						1	Hypoaesthesia; Paraesthesia	FLU3~SANOFI PASTEUR~U2189AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0619F~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0268631	12/11/2006	PA	1.31	1	.3	M	12/01/2006	9 days post immunization had complex febrile seizure, see attached report. EEG MRI pending.				Y	Y				Y	11/16/2006	11/24/2006	8		PVT	PVT	NONE					1						1	Febrile convulsion	FLU3~SANOFI PASTEUR~U2204AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~1094F~1~SC~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Hospitalisation	Influenza
0268632	12/11/2006	VA	85.0	84		M	11/20/2006	Received flu shot on 11/13/06 at a community clinic at approximately 11:30 am. At bed time (10 pm) patient noticed itching from waist down. by 12 midnight itching intensified. Patient denies seeing any rash. Patient denies any other symptoms. He reported that by morning itching had resolved and no further problems noted.									Y	11/13/2006	11/13/2006	0	NONE	PUB	PVT	ZOCOR, FLOMAX, ? SULATAIRE, COUMADIN, ADVART, LASIX	No acute illness	Allergy to codeine, atherosclerosis, increase prostate, A-fibrillation		VA06034	1						1	Pruritus	FLU3~SANOFI PASTEUR~U2286AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268633	12/11/2006	VA	50.0	50		F		Client stated right arm began swelling with redness and tenderness approximately one hour after receiving Tdap. R deltoid sore to touch and warm for about a week. Swelling subsided after that time period. No further follow up recommended. Was accessed by Medical Director. Warm to cold compresses recommended.									Y	10/17/2006	10/17/2006	0	NONE	PUB	OTH	NONE	NONE	NONE			1						1	Erythema; Feeling hot; Swelling; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70385~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C2491AA~UNK~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0268635	12/11/2006	VA	40.0	40		F	11/08/2006	Noted burning, soreness then swelling approximately 1 hour post immunizations. Swelling encomposed entire R deltoid lasting for 11 days. Noted a nodule after swelling subsided for 3 days. Area assessed by Medical Director. Warm to cold compresses recommended.									Y	10/17/2006	10/17/2006	0	NONE	PUB	OTH	Atenolol	NONE	Peanuts, almonds, tuna, latex, dust, mites, most trees.			1						1	Skin burning sensation; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70385~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C2491AA~1~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0268636	12/11/2006	TN	60.0	60		F	12/01/2006	Patient returned to clinic on 12/01/06 with a red raised area on right arm with yellow drainage. Rocephin 1 gram IM given. Wound care supplies, Bacitracin ointment and instructions for wound care given also cephalaxin 500 mg 1 BID for 14 days.				Y					Y	11/09/2006	12/01/2006	22	wound culture abscess	PUB	PUB	NONE	NONE known	NONE known			1						1	Abscess; Rash erythematous	FLU3~SANOFI PASTEUR~LU2242AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2609AA~UNK~IM~~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0268638	12/11/2006	TN	67.0	67		M	11/07/2006	Patient states he noticed a knot with red area on 11/02/06 on left arm. No drainage noted on left arm Td area. Patient also noticed lump at Flu site area 11-4-06. Observed 12mm ulcerated area on left arm approximately 3 inches below injection site. Red area with warmth noted. Patient states.				Y					U	10/25/2006	11/02/2006	8	NONE as of 11-7-06	PUB	OTH	BENAZEPRIL, NORVASC		Diagnose 7 years ago CL leukemia, sees oncologist			1						1	Erythema; Injection site mass; Injection site warmth	FLU3~SANOFI PASTEUR~U2239AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~MASS. PUB HLTH BIOL LAB~Td156~UNK~~LA~TD ADSORBED (TDVAX)~1	USA	Emergency room visit	Influenza
0268639	12/11/2006	TN	76.0	76		M	11/07/2006	Patient complains of being dizzy when standing and walking. He feels ok when lying down.									U	11/06/2006	11/06/2006	0	NONE	PUB	PVT	Takes Cholesterol medicine and blood pressure medicine.	NONE	Hypertension		TN06028	1						1	Dizziness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71641~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268640	12/11/2006	TN	8.0	8		F	11/07/2006	Approximately 10 minutes after vaccine administered, child complain of dizziness, itching. Mother reported child pale. Stayed in health department for 40 minutes after leaving . Mother reports that child broke out in rash on chest and right arm. Rash was red, itchy and lasted about 1 hour. Did not to medical doctor. No problem since.									Y	10/25/2006	10/25/2006	0		PUB	PUB	UNK	NONE	Allergies-PCN		TN06027	1						1	Dizziness; Pallor; Pruritus; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500437P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0268642	12/11/2006	TN	71.0	71		F	10/31/2006	Patient states she received a flu shot and the next day woke up with a rash on her body covering her head, back, legs, abdomen, hands and feet. She went to ER at hospital and received a sternal shot. Doctor told her she was allergic to vaccine and not to take the shot again.				Y					Y	10/25/2006	10/26/2006	1	NONE	PUB	UNK	Vitamin B12	Diabetic, vaginal cancer, arthritis	morphine, codeine, phenegan and demerol		TN06025	1						1	Rash	FLU3~SANOFI PASTEUR~V2244AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268643	12/11/2006	CA	45.0	45		F	11/07/2006	Benadryl 25mg intramuscular one time. Given in right deltoid. No driving. Watch for fever. If develops go to ER.				Y					Y	11/07/2006	11/07/2006	0	NONE	PUB	PVT						1						1	Vaccination failure	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72002~2~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0268644	12/11/2006	FL	46.0	46		F	11/10/2006	Within 2 hours after injection arm became sore, hot, edematous. 11/10/2006 visualized edema, warm, red, indurated area 3 inches x 55 mm at site with welt-like raised areas pattern of band-aide previously on site.									Y	11/09/2006	11/09/2006	0		MIL	PVT		NONE	NONE			1						1	Erythema; Injection site induration; Injection site warmth; Oedema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71830~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268645	12/11/2006	NC	46.0	46		F	11/15/2006	Itching under bra line and inner thighs with rash. Tongue swelling, headache, fever. Lasted about 16 hours then patient was fine. Took aspirin for fever.									Y	11/14/2006	11/14/2006	0	NONE	PUB	PVT	NONE	NONE	NONE			1						1	Glossitis; Headache; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~U2247AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268646	12/11/2006	NC	1.57	1	.6	M	12/08/2006	Area around shot site of either DTP or Hib titer 2 in. in diameter, mild erythema, slight warmth but no tenderness and no induration.				Y					Y	12/04/2006	12/05/2006	1	NONE	PVT	PUB	Tylenol	gastroesphageal illness last week	NONE			1						1	Erythema; Feeling hot; Injection site inflammation	DTAP~SANOFI PASTEUR~U1751CA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2244AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0403F~4~IM~LL~HIB (PEDVAXHIB)~1	USA	Emergency room visit	Influenza
0268647	12/11/2006	CA	69.0	69		F	12/04/2006	Two days past immunization patient complained of increased pain with swelling at left arm.  With distal small area of erythema Probable reaction to Pneuomax. Evaluated at 11-19-06. Patient went to ER 11-30-06 with increase pain.				Y						11/27/2006			NONE	PUB	PVT			No known allergy. Diabetes, hypertension, breast cancer, restless leg syndrome			1						1	Erythema; Injection site swelling; Pain	FLU3~SANOFI PASTEUR~U2251AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0620F~UNK~~LA~PNEUMO (PNEUMOVAX)~1|TD~AVENTIS PASTEUR~U1617AA~UNK~~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0268648	12/11/2006	OR	12.0	12		M	11/28/2006	Patient came in for vaccines with mother. Very anxious and agitated. Patient had to be held down in order to give shots as he was combative, otherwise tolerates well. Patient returns for PDD reading 11/27/06, Left deltoid area red, warm and painful. Foster mom already using Tylenol and cortisone cream, told to continue.									Y	11/24/2006	11/25/2006	1	NONE	PVT	OTH	PPD, 23081, LA, 0	NONE	No known drug allergies. ADHD			1						1	Anxiety; Erythema; Feeling hot; Pain	FLU3~SANOFI PASTEUR~U2168CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0651F~1~IM~RA~HEP A (VAQTA)~1|PPV~MERCK & CO. INC.~0985F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268649	12/11/2006	NM	13.0	13		F	11/15/2006	AFter vaccine was given IM, patient said felt nausea.  I asked her to sit down and instructed to go to bathroom if needed and to wait in store for 15 minutes.  3 minutes later, patients eyes rolled in back of head and she had seizure like symptoms.  Patient refused epi pen and was breathing.  Patient was laid on floor until paramedics arrived.				Y					Y	11/15/2006	11/15/2006	0	breathing 99% on room air per fire department O2 monitor.	OTH	PVT	NONE	NONE	Peanut and dairy product allergy			1						1	Dyskinesia; Eye movement disorder; Nausea	FLU3~SANOFI PASTEUR~U2218AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268650	12/11/2006	TX	57.0	57		M	12/04/2006	Dizziness, off balance, uneven walk 0600 hrs 16 Nov 06. Treatment- stop all medication. Waited till symptoms resided. 0800 hrs 20 Nov 06.									Y	11/15/2006	11/16/2006	1		MIL	PUB		NONE				1						1	Balance disorder; Dizziness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0268651	12/11/2006	NY	66.0	65		F	12/04/2006	Temp 102 for 12 hours. 5 welts for 3 days									Y	12/11/2006	12/11/2006	0		PVT	UNK		NONE				1						1	Pyrexia	FLU3~SANOFI PASTEUR~0988F~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~U224AA~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268676	12/11/2006	MI	1.06	1	.1	M	12/11/2006	Thrombocytopenia, with platelet count of 17,000, developed on Dec. 7.  Patient had received vaccines on Dec. 6. 12/14/06 Received medical records from provider which reveal hospital labs of 12/8/06 with platelets of 17,000, segs 46, lymphs 40 compatible with ITP. 1/2/07 Received hospital medical records which reveal patient admitted 12/8/06 with spontaneous bruising & petechiae.  Improved & d/c to home 12/10 w/heme f/u.  No d/c summary available. HPI: diarrhea several days prior to admission, bruising/petechiae 1 day prior to admission on forehead, neck, arms, legs abdomen & buttocks.  Patient had been seen by PCP 2 days prior to admit for well child vs & given vax.  Took back to PCP & CBC revealed WBC of 8.72, plts 17,000, 46 % segs, 1% bands, 40% lymphs, 6% monos, 1% eos. ADMIT DX: probable ITP idiopathic thrombocytopenic purpura.			Y		Y	2			Y	12/06/2006	12/07/2006	1	12/8/06 platelets of 17,000, segs 46, lymphs 40.	UNK	UNK			Birth Hx: 39 wks, SVD, 8 lbs, 14 oz, no complications. Family hx: sibling with neurofibromatosis.  Father with heart murmur. PMH: recurent yeast infections			1						1	Contusion; Petechiae; Platelet count decreased; Thrombocytopenia; White blood cell count increased	FLU3~SANOFI PASTEUR~U2199AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB099CB~1~IM~LL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~B08655C~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Life Threatening,Hospitalisation	Influenza
0268680	12/11/2006	OH	42.0	43		F	12/11/2006	Vaccine adminstered 12/7/06 in the evening.  On 12/9/06 am noticed 3 to 4 inch long by 2-1/2 to 3 inch bright red area indurated to approx 1 inch with warmth at injection site.  Denied pain at sight.									Y	12/07/2006	12/09/2006	2	No tests performed.  Employee self-reported above data to employee health on 12/11/06 at 9am.	UNK	UNK						1						1	Injection site erythema; Injection site induration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA206AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268683	12/11/2006	NV	42.0	41		M	12/11/2006	severe swelling and pain in arms high fever nausea headache grand mal seizure loss of consciussness head injury with broken nose hearing and vision problems dizziness mental confusion muscle weakness lethargy				Y					U	12/07/2006	12/07/2006	0	pending	PUB	PUB		no				1						1	Confusional state; Dizziness; Facial bones fracture; Grand mal convulsion; Head injury; Headache; Hearing impaired; Lethargy; Loss of consciousness; Muscular weakness; Nausea; Pain in extremity; Pyrexia; Swelling; Visual disturbance; Confusional state; Dizziness; Grand mal convulsion; Headache; Hearing impaired; Injury; Lethargy; Loss of consciousness; Mental impairment; Muscular weakness; Nausea; Oedema; Pain; Pyrexia; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~RA~PNEUMO (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~~UNK~IM~RA~PNEUMO (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0268684	12/11/2006	NY	25.0	24		M	12/11/2006	12/7 IN AM WOKE WITH A HEADACHE. BY 5 PM , R ARM IS VERY SORE,RED AND SWELLING AT INJECTION SITE. 12/8 WOKE AT 4 AM AND PO TEMP. OF 103.8 F. WITH ABD PAIN AND VOMITING. CALLED PMD AND ADVISED TO GO TO ED. AT ED TX WITH IV FLUIDS AND ANTEMETICS. SENT HOME AT 6 AM. CONTINUED WITH NAUSEA AND FEVER THROUGH 12/10. FEVER RAN BETWEEN 101-102 F. SORENESS, REDNESS, SWELLING DECREASED IN R ARM. TODAY FEELS BACK TO NORMAL WITH EXCEPTION OF R ARM SLIGHTLY SORE. HE WAS TOLD AT ED ON 12/8 THAT HE HAD A VIRAL ILLNESS BUT TO REPORT TO HEALTH DEPT.				Y					Y	12/06/2006	12/08/2006	2		UNK	UNK	VITORIN AND HUMULOG INSULIN	NONE	TYPE 1 DIABETIC			1						1	Abdominal pain; Headache; Injection site erythema; Injection site pain; Injection site swelling; Nausea; Pyrexia; Viral infection; Vomiting	FLU3~SANOFI PASTEUR~U2308AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0881F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0268685	12/11/2006	WI	0.79	0	.8	M	12/11/2006	Mother called health department on 12/11/2006 because she was worried that the child got a bigger dose of the influenza vaccine.  She states that he came down with a 102 fever on 12/6/2006, which was 2 days after the influenza vaccine was given and 104.5 temperature just under 3 days after the vaccine.  She states that my baby is not the same baby.  The child will only sleep an hour at a time and had been crying hour after hour up until 12/10/06.  She states that he was lethargic, fussy, not eating and constantly crying.  The baby also had a runny nose and slight cough.  Mother treated temperatures with Tylenol and did call the MD.  The MD told client it was a normal reaction from the vaccine.  She states that the client had a period of apnea after given Tylenol.  She states on 12/11/2006 the child had a vomitting episode as well.									Y	12/04/2006	12/06/2006	2	None	UNK	UNK	NONE	NONE	NONE	Brother~Influenza (Seasonal) (no brand name)~1~0.80~In Sibling|~Influenza (Seasonal) (no brand name)~~0.00~In Sibling		1						1	Anorexia; Cough; Crying; Incorrect dose administered; Irritability; Lethargy; Pyrexia; Rhinorrhoea; Sleep disorder; Vomiting	FLU3~SANOFI PASTEUR~U2220EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268687	12/11/2006	CT	0.0	32		F	12/11/2006	Within several hours of the Flumist, she developed chills and aches followed by nausea and sweating.  The symptoms were more severe on the following day with a temperature of 103.  She continued to have some fever for approximately 48 hours.  On day #3 post vaccine, she felt very tired and was back to normal on day #4.									Y	12/06/2006	12/06/2006	0		UNK	UNK	none	none	penicillin			1						1	Chills; Fatigue; Hyperhidrosis; Nausea; Pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500438p~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0268689	12/11/2006	CO	29.0	29		F	12/11/2006	- Tightness in the chest - Difficulty swallowing - Sweting - Hoarse/rough feeling in throat - Constant coughing attempting to open breathing path/ thight chest feeling - Dizziness				Y					Y	12/10/2006	12/10/2006	0	Allergic reaction to Flu vaccine	UNK	UNK	WELLBUTRIN SR (150 MG)	NO	PENICILLIN, CODEINE			1						1	Chest discomfort; Cough; Dizziness; Dysphagia; Dysphonia; Hyperhidrosis; Hypersensitivity; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~49281-0378-15~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268690	12/11/2006	MA	71.0	71		F	12/11/2006	Vaccine AM 11/30/06.  About 6 hrs later about 6-in area of redness at site. Since then generalized rash on all body surfaces, with target lesions, and with lip involvement.  Some areas with petechiae, some with ecchymoses. Pt hospitalized today (I'm ID consultant).  No trouble with previous yearly flu shots. No h/o egg allergy. 12/13/06-inpatient H&P and I& D Consultation report received and reviewed. Impression: E. multiforme-like rash following flu shot. Suspect that if this is related to vaccine the offending agent is in the vehicle rather than in the subvirion components since rash with flu infection itself is so very rare. Rash at injection site occurred 6-8 hours after vaccine. Now on trunk, lips are sore. Rash is mainly itchy not painful.  HX breast cancer August 2006.  01/12/07-DC summary received and reviewed for DOS 12/11-12/13/06 DC DX: Hypersensitivity Reaction Treated with Solu-Medrol. DC on Prednisone and Benadryl.  Have not been able to reach pt. for follow-up   Follow-up received APR 02 2007 - pt partially recovered. According to PCP much improved by 12/21 but referred to dermatologist for follow-up.				Y	Y	1			U	11/30/2006	11/30/2006	0	Pending at this time. Punch biopsy of upper back: superficial perivascular dermatitis with eosinophils and spongiosis, consistent with a cutaneous hypersensitivity reaction to an endogenous or exogenous antigen.	UNK	UNK	Tamoxifen	None	Tetracycline allergy Sulfa allergy Breast CA excision 8/06			1						1	Biopsy skin; Ecchymosis; Erythema multiforme; Hypersensitivity; Injection site erythema; Injection site rash; Lip pain; No reaction on previous exposure to drug; Perivascular dermatitis; Petechiae; Rash generalised; Rash pruritic; Skin lesion	FLU3~SANOFI PASTEUR~U2307AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0268691	12/11/2006	SD	1.4	1	.5	F	12/11/2006	Developed erythema multiforme - started out on 12/4/06 looking like hives but on 12/5/06 looked more like erythema multiforme.  Also had PE tubes placed on 12/1/06 and given Floxin drops.  Also received flu vaccine on 11/29/06.				Y					Y	11/29/2006	12/04/2006	5	Complete blood count done	PVT	PUB	Floxin	No illness at time of Flu  vaccine given.	Recurrent Otitis media and hemangioma			1						1	Erythema multiforme; Full blood count	FLU3~SANOFI PASTEUR~U2220AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268692	12/11/2006	TX	46.0			F	12/11/2006	Pt experienced drop in blood pressure and changes in HR. Pt received NS bolus and placed in supine position.									Y				SBP fell from 85 to 65, heart rate changed to 45bpm, junctional rhythm	UNK	UNK		Hyperglycemia/Chest Pains	Hx of DM			1						1	Arrhythmia; Blood pressure decreased; Bradycardia	FLU3~SANOFI PASTEUR~U2272AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268693	12/11/2006	CO	33.0	34		F	12/11/2006	11/20: PT DEVELOPED HA AND VOMITING ABOUT 1 HR AFTER SHOTS THEN GOT SORE MUSCLES 12/6: FIRST SPOT NOTED 12/8: PT HAVING DIFFICULTY USING HANDS DUE TO PAINFUL STIFFNESS.  PT C/O NIGHT SWEATS, SORE MUSCLES, NOW BREAKING OUT W/SPOTS, ITCHY AND PAINFUL.  TROUBLE SWALLOWING 2ND TO PAIN.  NO DIARRHEA.  URINE NL.  EYES ITCHY AND BLURRY.  COUGH FOR SEVERAL MONTHS - HURTS TO COUGH.  USING APAP AND IBUPROFEN AT HOME - MOSTLY APAP AT NL DOSES. RANITIDINE 150 MG BID FOR GERD AND IBUPROFEN 800 MG TID FOR PAIN/INFLAMMATION STARTED 12/11 (11:15 AM): PT STATES HA WORSENED AND BUMPY RASH ALL OVER BODY LABS NORMAL									Y	11/20/2006	12/08/2006	18	12/8: ALL LABS WNL HEPATIC FUNCTION PANEL CBC W/DIFF SR CREATINE URINALYSIS WBC W/DIFF	UNK	UNK	CIPROFLOXACIN MALARONE	HEALTHY	ALLERGIES: ANESTHETIC, TEGRETOL, AMOXICILLIN W/CLAVULANATE, DESPIRAMINE, ADHESIVE TAPE, IODINE AND IODINE CONTAINING PRODUCTS AND HYDROXYZINE PMH: ANXIETY, GANGLIONEUROMA OF MEDIASTINUM, BENIGN, DORSALGIA, STRESS DISORDER, CHRONIC PAIN SYNDROME, ACHWANNOMA SPINAL CORD			1						1	Cough; Dysphagia; Eye disorder; Headache; Musculoskeletal stiffness; Myalgia; Pruritus; Rash; Rash pruritic; Vision blurred; Vomiting	FLU3~SANOFI PASTEUR~U2248AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0496-2~UNK~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|TDAP~SANOFI PASTEUR~C2609AA~1~IM~LA~TDAP (ADACEL)~1|TYP~SANOFI PASTEUR~Z0572~1~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|YF~SANOFI PASTEUR~UE913AA~1~SC~LA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0268694	12/11/2006	KY	27.0	27		F	12/11/2006	Within a minute after receiving the shot, I felt dizzy, then passed out completely. While passed out I was noted to be extremely pale & had trouble breathing. Within a few minutes I was awake & aware again. Felt nausea a few minutes after that. Within the next 30 minutes I slowly begin to feel more normal.				Y					Y	12/09/2006	12/09/2006	0	none to report	UNK	UNK	Yasmin	NONE	NONE			1						1	Dizziness; Dyspnoea; Loss of consciousness; Nausea; Pallor	FLU3~SANOFI PASTEUR~U2258AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268695	12/11/2006	MT	0.33	0	.3	F	12/11/2006	Fever 103, not reduced by acet. or ibuprofen for 48 hours, swelling at injection site with pain									Y	04/14/2006	04/14/2006	0		UNK	UNK	Acet. and Ibuprofen	None	None			1						1	Injection site swelling; Pyrexia	DPP~UNKNOWN MANUFACTURER~unk~2~IM~RL~DIPHTHERIA TOXOID + PERTUSSIS + IPV (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~unk~2~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0268696	12/11/2006	MO	34.0	34		M	12/07/2006	Shoulder began to feel irritated (itchy) could not see anything wrong. Just itchy under skin.									Y	11/02/2006	11/11/2006	9	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Skin irritation	FLU3~SANOFI PASTEUR~U2169AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268697	12/11/2006	MS	61.0	61		F	12/11/2006	Took flu shot Tuesday 12/05/06 around 8:15am; 12/06/06 at (pt says 2:36AM) felt funny 12/06/06 AM. Developed Right side of tongue felt asleep. Right arm and hand weak and Right leg weak and reports slow in walking and joint tingles. (Friend with patient said patient thought she would get better and waited. 12/7/06 called Dr and went to see him around 9:30 12/07/06. Was crying and depressed (per patient) and Dr. told her no heart problem, no stroke and put her on Celexa. Today 12/11/06 (around 10:15am) patient here to report question about reaction to flu shot. Smile is normal, seems to have equal strength hands and legs. States her _____ is much better but she still feels funny, doesn't feel stable when walking. Doesn't write like normal and doesn't do things as fast as usual. She requested blood pressure taken. B/P 258/90. Sent immediately to Dr. if can't be seen to go to ER. Dr.'s office called and reported she is on her way.				Y					N	12/05/2006	12/06/2006	1	Dr. sent to hospital for blood work. Questioning if patient is diabetic.	PUB	PUB	Hemalog, Toprol, Furosemide, Metformin, experimental blood pressure med	None except is diabetic and has increased blood pressure	Diabetes and increased blood pressure			1						1	Asthenia; Crying; Difficulty in walking; Feeling abnormal; Hypertension	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71032~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0267745	12/12/2006	TX	51.0	51		F	11/29/2006	10:30am shot reaction 10:40 numbness, nausea, increase B/P, rash Benadryl PO given. To ER for Decadron  IV at 11:15am. Back to  Dr's 11/14/06 and more Decadron, Zyrtec and Medrol dose pack given along with Benadryl off x 1 week.				Y					Y	11/13/2006	11/13/2006	0		PUB	UNK		NONE	NONE			1						2	Anaphylactic reaction; Flushing; Hypertension; Malaise; Paraesthesia; Rash; Blood pressure increased; Hypoaesthesia; Nausea; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70738~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70738~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0268698	12/12/2006	CA	35.0	34		M		11/28/06-9-10pm to 11/29/06 12pm acute hives. Resolve with Claritin. 11/28/06 to present persisting numbness, tingling paresthesias present. No treatment.				Y					U	11/28/2006	11/28/2006	0	Potassium, Calcium, Complete Blood Count with diff, Thyroid stimulating hormone, pending creatinine kinase	PVT	PVT		NONE	History of allergic rhinitis, eczema, episodic hive 3-4times past year.			1						1	Hypoaesthesia; Paraesthesia; Urticaria	FLU3~SANOFI PASTEUR~U2166KA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268714	12/12/2006	MI	5.0	5		M	12/06/2006	Visible swelling of right arm over deltoid and extensor, aspect of triceps area with hyperpyrexia (up to 102) Full ROM but tender to touch. SX resolved in about 36 hours with full recovery.  MR received for an ER admit for c/o fever (102.7F), pain and swelling of the right upper arm at the pnemococcal vax. site.  PE: WNL except decribing a well-defined, erythematous, warm area of swelling on the RUE. Admitted for IV antibiotics. Final DX: Cellulitis, right arm.					Y				Y	11/22/2006	11/22/2006	0	Plain X ray, soft tissue swelling, WBC 35.5, H 68.2 (pt has SCD), Blood culture neg.  Labs and Diagnostics:  CRP 50.07, Hgb low x3 (8.1, 7.5, 6.9), Hct low x3(23.4,21.4,20.3), Reticulocytes elevated (262300,222500,254900), Blood cultures (-).	PUB	PUB	Meds: Tylenol#3.		Sickle Cell Anemia PMH: Sickle Cell Disease, asthma.  Allergies: NKDA.			1						1	Anaemia; Blood disorder; Hyperpyrexia; Injection site oedema; Laboratory test abnormal; Tenderness	FLU3~SANOFI PASTEUR~U2187AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~957093~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0268716	12/12/2006	WV	0.5	0	.5	M	12/07/2006	Infantile spasms, similar events occurred sporadically prior to his immunizations at 6 months, but increased dramatically in severity and frequency on 12/06/2006 12/19/06-records received and reviewed. PMH: Possible infantile spasm Regression 2 week history. Developed normally for 5 1/2 month old baby when he developed head nodding spells approximately 1 month prior to admission.  Formulation: 6 month old baby boy with onset of likely infantile spasms with an abnormal EEG.  DC DX: for DOS 12/11-12/14/06 Infantile spasms West's syndrome development regression, acute. Subtle infantile spasms identified 4 weeks prior to admission  MRI brain, normal for age Annual follow up information received indicates patient is now seizure free for a year and development is normal. Per 60 day follow up: Infantile spasms resolved. At this time, he still has hypertension related to ACTH treatment for infantile spasms.								Y	Y	12/04/2006	12/06/2006	2	EEG showed seizure activity/infantile spasms abnormal EEG MRI of brain normal for age. EEG: frequent infantile spasms were detected, clinically manifested by brief tonal flexion with arm extension and change in face and demeanor lasting approximately 1 second.	PVT	PVT	NONE					1						1	Condition aggravated; Convulsion; Electroencephalogram abnormal; Hypokinesia; Infantile spasms; Nuclear magnetic resonance imaging brain normal	DTAP~SANOFI PASTEUR~C2630AA~3~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U72176AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE965AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B08646H~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Disabling	Influenza
0268717	12/12/2006	NC	38.0	37		F	12/01/2006	1:46pm at first dizziness, had client sit with nurse took BP, relax techniques. 2:00 came back throat closing tight. given Benadryl 1.25 fast melt no results. Getting worse Epi 1/1000 0.3cc SQ at 2:05pm then again 2.15pm called 911 DIT worse, SOB, throat closing now chest pain. 911 to Hospital. 12/21/06-records received. DX: Allergic reaction. received epinephrine injection in ER, CT showed some laryngeal and pharyngeal edema without obvious tongue, lip or papular edema. Allergic to penicillin and sulfa.  Impression: angioedema of oral pharynx  Some thrombophlebitis of left arm from IV therapy.				Y	Y	2			Y	11/21/2006	11/21/2006	0	CT showed some laryngeal and pharyngeal edema without obvious tongue, lip or papular edema.	PUB	PVT	NONE		Allergy to PCN, sulfa only.			1						1	Chest pain; Dizziness; Dyspnoea; Hypersensitivity; Laryngeal oedema; Throat tightness; Thrombophlebitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71646~2~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0268718	12/12/2006	IL		0	.8	U		Immediate confluent erythema on lower extremities and irritability. Lasted approximately 15-20 minutes.									Y	12/06/2006	12/06/2006	0		PVT	UNK		NONE	NONE			1						1	Erythema; Irritability	FLU3~SANOFI PASTEUR~UT2174LA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268719	12/12/2006	TX	30.0	29		F	11/29/2006	Rash under skin, non red 10pm 11-28-06 on stomach/back/shoulders. Turned red (bumps) and extended down arms to hands and 12-4-06 extending to legs.									U	11/28/2006			None as of 12-1-06.	OTH	UNK	NONE	NONE	NONE			1						1	Erythema; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F602611~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268720	12/12/2006	CA	5.0	5		F	12/07/2006	Fever, treatment Rocephin 500 mg 10/23/06. Frequent urination on 11/5/06. Sore throat and fever on 12/1/06. Fever on 12/3/06 and 12/4/06.									Y	10/17/2006			Cystitis	PVT	OTH	NONE	NONE	NONE			1						1	Cystitis; Pharyngolaryngeal pain; Pollakiuria; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500432P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0268723	12/12/2006	WA	5.0	4		M	12/07/2006	Swelling of upper two-thirds of R arm. Outer arm beneath vaccine site 2 days after vaccine.									Y	12/05/2006			NONE	PVT	PUB		NONE	NONE			1						1	Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70740~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268724	12/12/2006	TX	9.0	8		F	11/29/2006	11-28-06 3:00pm vaccine administered in right deltoid. Advised Tylenol every 4 hours times 24 hour to combat any muscle soreness , aches. 11-29-06 08:00 complained of feeling like have flu-weak, achy, Temp 98.8. At 11:00 same day tem 99.9, complained of weak, neck pain, feet feel numb/tingling. Sent home to go to Dr.									Y	11/28/2006	11/28/2006	0	NONE	OTH	UNK	Topomax, Apri, Relpax	NONE	migraine headaches			1						1	Influenza like illness; Neck pain; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F602611~7+~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268725	12/12/2006	OH	75.0	74		F	12/07/2006	Patient states 1 week after injection right arm became painful; top of shoulder to hand. Loss of motion and weakness. Went to ER. R arm improving now.				Y					Y	11/09/1997	11/16/2006	3294		PUB	PUB	NONE	NONE	NONE			1						1	Joint range of motion decreased; Muscular weakness; Pain	FLU3~SANOFI PASTEUR~U2268AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0320F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0268726	12/12/2006	FL	1.02	1	.0	M	11/27/2006	11-21-06 onset with fever (102-103), red spot on Left thigh, seen in ER. 11-25-06 office visit Left thigh with nontender, 1cm nodular erythematous patch, ?? early superficial veseculation. Bilateral inguinal adenopathy 1cm 3-4 each side. Treatment: warm soaks, treat fever, close observation.				Y						11/13/2006	11/21/2006	8		PVT	PVT	Omnicef for bilateral otitis media	well baby with bilateral otitis media. Diagnosed 11-6-06 on Omnicef.	NONE			1						1	Erythema; Injection site nodule; Lymphadenopathy; Pyrexia; Rash vesicular	FLU3~SANOFI PASTEUR~U2174EA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0106F~3~~RL~HEP B (FOREIGN)~1|MMR~MERCK & CO. INC.~0700F~1~~LL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|VARCEL~MERCK & CO. INC.~1046F~1~~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0268727	12/12/2006	FL	1.04	1	.0	F	11/28/2006	11-20-06 nodule Left groin area. Right groin with 4 3/4 cm shotty mobile nodes, not matted. Left groin with 3 shotty nodes, recheck 10 days or sooner. 11-24-06 axillary adenopathy, inguinal nodes bilateral shotty 3/4 cm. Re check next week-sooner 5-6 on Right femoral, 2-3 on Left not matted. 11-27-06 no real change in nodes. Left thigh with 1cm erythema slight induration. Recheck in a week.										11/13/2006	11/20/2006	7		PVT	PVT	NONE	NONE	NONE			1						1	Erythema; Lymphadenopathy; Skin nodule	FLU3~SANOFI PASTEUR~U2174EA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0106F~3~~RL~HEP B (FOREIGN)~1|MMR~MERCK & CO. INC.~0700F~1~~LL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|VARCEL~MERCK & CO. INC.~1046F~1~~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0268728	12/12/2006	WI	1.14	1	.1	M	12/07/2006	Multiple (>50) diffuse pox lesion-concentrated in genital and perianal region. Onset 8 days post immunization.									N	11/29/2006	12/07/2006	8	NONE	PVT	PVT		Strep throat (confirmed on 12/01/06)	NONE			1						1	Skin ulcer; Urticaria	FLU3~SANOFI PASTEUR~U21740A~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0717R~3~IM~LL~HIB (PEDVAXHIB)~1|VARCEL~MERCK & CO. INC.~024F~UNK~UN~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0268729	12/12/2006	CT	63.0	62		M	12/07/2006	Developed pain lateral aspect of Right thigh then waist then lateral aspect torso. Then on 12/3/06 he developed a rash on right thigh. Clusters of small gray macules scattered in dermatone L3+4.									N	11/16/2006	12/28/2006	42	NONE	PVT	PVT		healthy	NONE			1						1	Pain; Rash; Rash macular	FLU3~SANOFI PASTEUR~U2164A~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~0981F~UNK~~~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0268730	12/12/2006	TN	5.0	4		F	12/06/2006	5.5cmx4cm red and hot to touch.									Y	10/24/2006	10/26/2006	2		PVT	PVT	NONE	NONE	NONE			1						1	Erythema; Feeling hot	FLU3~SANOFI PASTEUR~U2168AA~5~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0807F~2~SC~~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|VARCEL~MERCK & CO. INC.~0919F~2~SC~~VARICELLA (VARIVAX)~1	USA		Influenza
0268731	12/12/2006	GA	0.52	0	.5	F	12/04/2006	Fever at 103-104 the night of the shot for about 3-4 hours and much crying. Fever next day 101-102.									Y	11/30/2006	12/01/2006	1	NONE	OTH	PUB		Diaper rash- possible staph and yeast	NONE			1						1	Crying; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B0T3AA~2~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2201CA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1008R~3~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08658F~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0268732	12/12/2006	MA	10.0	9		M	12/05/2006	Caused brusitis and lymphadenitis. Second inflammation from influenza vaccine.									Y	10/17/2006	10/18/2006	1	MRI	PVT	PUB			Diabetes			1						1	Contusion; Injection site inflammation; Lymphadenitis	FLU3~SANOFI PASTEUR~U2178AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268735	12/12/2006	CA	51.0	51		M	10/27/2006	Disorientation eyes couldn't focus swelling of eyes and all around eyes, eyes turned very red blood shot, crusty sand like substance all around eyes. Flu like symptoms very strong. Unable to concentrate, sun tan look all around eyes on face was red.									U	10/25/2006	10/25/2006	0	NONE	PVT	PVT	Asopex, Busbar.	NONE	Allergies penicillin, no others.	dizziness, disorientation~ ()~~41.00~In Patient		1						1	Disorientation; Disturbance in attention; Erythema; Eye disorder; Eyelid oedema; Influenza like illness; Ocular hyperaemia; Staring	FLU3~SANOFI PASTEUR~U2242AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268736	12/12/2006	IL	57.0	57		F	12/06/2006	High Fever, left arm very red, swollen, hot above elbow and very painful. Seen by urgent care doctor who ordered blood test and diagnosed cellulitis, prescribed antibiotic Omnicef. Follow up by family doctor, currently under doctors care. Nurse who administered vaccines was distracted by the small daughter of another worker. Child picked up vials of vaccine.				Y					U	11/27/2006	11/28/2006	1	Blood test at urgent care center	OTH	UNK	Tylenol	NONE	Penicillin			1						1	Cellulitis; Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0268737	12/12/2006	FL	74.0	73		F	12/03/2006	Freezing cold, than hot, no appetite, all over sick feeling, no energy. It is 3 weeks from the day of the vaccination, and I am still feeling weak etc. Talked to other people about this, and many had the same problems.									N	11/09/2006				UNK	UNK		NONE				1						1	Anorexia; Asthenia; Feeling cold; Hot flush; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0268738	12/12/2006	FL	72.0			F	12/03/2006	Flu shot rt arm, chills and fever 8 hours after shot. Lasted several hours. Pneumococcal left arm, within 8 hours upper arm extremely sore, soreness lasted 5 days.									Y					PVT	UNK	Blood pressure med Estrogen	NONE				1						1	Chills; Injection site pain; Injection site reaction; Pyrexia	FLU3~SANOFI PASTEUR~2279AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0845~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268740	12/12/2006	WV	30.0	30		M	11/30/2006	Fever, joint pain, chills, muscle aches took 2 Aleve went to bed, sweat it out. Symptoms lasted about 18 hours.									Y	11/28/2006	11/28/2006	0		OTH	PUB	Metformin, Zoloft, Tarka, Allegra, Flonase	NONE	Type II Diabetic, cat/dog/grass/wood allergies.			1						1	Arthralgia; Chills; Myalgia; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F602111~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268741	12/12/2006	WI	50.0	50		F	12/05/2006	1/2 hr after inj felt a terrible deep pain travel down left arm. With days after pain radiated across shoulder, had pins and needles in both hands shot was given very high up on tip of shoulder. Left hand discoloration. Felt weak, Went to employee health. Said I got a tendonitis.									Y	10/30/2006	10/30/2006	0		PVT	UNK	PPD		Demerol, morphine.			1						1	Asthenia; Injection site pain; Paraesthesia; Shoulder pain; Skin discolouration; Tendonitis	FLU3~SANOFI PASTEUR~62212AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268742	12/12/2006	OH	77.0	77		F	12/05/2006	C/O left arm swelling and nausea, vomiting.				Y					Y	11/30/2006	12/01/2006	1		PVT	PVT	Ativan, Protonix, Norvasc, Coumadin, Lopressure, Vasotec.	c/o ongoing stomach pain	Ceclor, Amoxil, Enycin, sulfa, Macrobid, Cipro, floxin, Cefzil.			1						1	Injection site oedema; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U2308AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1044P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0268745	12/12/2006	NY	42.0	42		F	12/05/2006	10 min after given flushing, nausea, headache, petechia back, came to RN office, redness decrease to chest with hives. Benadryl 50mg IM given, V/S prior 11am 143/76m 78 16 after 11:15 144/82 74, 11:30 pt fine. Returned to class room.									Y	12/01/2006	12/01/2006	0		OTH	UNK	Vasotec, Nexium	S/E	seasonal allergies, sinus-latex.			1						1	Erythema; Flushing; Headache; Nausea; Petechiae; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F602611~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0268746	12/12/2006	OR	57.0	57		M	12/04/2006	Fever, weakness, general body aches, injection site pain starting evening of injection and continuing still today. Fever running 103-104 F and is reduced to 99-100 with NSAID and Tylenol use.									N	12/01/2006	12/01/2006	0		OTH	PVT			High blood pressure	malaise~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Asthenia; Injection site pain; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2252AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0958F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268747	12/12/2006	NJ	87.0	87		F	11/30/2006	Patient developed 2 days pain, erythema, and tenderness of left arm, spreading into forearm.				Y					Y	11/27/2006	11/29/2006	2		PVT	PVT	Effexor, Cardiazam.		Depression, diabetes type 2, hypertension, arthritis.			1						1	Injection site erythema; Injection site pain; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69428~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0888f~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0268748	12/12/2006	MA	61.0			M	12/06/2006	Received first flu shot on 12/2. Approximately six hours later developed muscle aches, extreme fatigue, bleeding gums, swelling of tissue under the tongue, barking cough and redness in eyes. Symptoms resolved after 24 hours.									Y	12/02/2006	12/02/2006	0		PUB	PUB	UNK	NONE	NONE			1						1	Cough; Fatigue; Gingival bleeding; Myalgia; Ocular hyperaemia; Tongue oedema	FLU3~SANOFI PASTEUR~U2279AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268749	12/12/2006	IL	37.0	37		F	11/30/2006	Within 2 hrs of vaccination developed scratchy throat, difficulty swallowing and some respiratory distress. No action taken subsided 1 hr later.									Y	11/22/2006	11/22/2006	0		PUB	PUB	Mom takes nasal spray doesn't know name		Allergic peanuts, Keflex, Sulfa, Latex, Ditropan.			1						1	Dry throat; Dysphagia; Respiratory distress	FLU3~SANOFI PASTEUR~U2192AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268750	12/12/2006	IL	4.0	4		F	11/30/2006	3 days after Imm developed large local reddened lump on right arm (SubQ) gradually subsided site of ProQuad.									Y	11/22/2006	11/22/2006	0		PUB	PUB						1						1	Injection site erythema; Injection site mass; Injection site reaction	DTAP~SANOFI PASTEUR~C2650AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2201BA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z00012~3~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~1090F~UNK~SC~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0268751	12/12/2006	WA	65.0	65		M	11/13/2006	Pneumovax administered at flu clinic at 11am. Returned at 1:25pm with c/o pain, inability to move arm. Nr redness, swelling noted. Referred to ER for eval. ER Dr gave vistarel and advised injection may have been given too high in deltoid (rotator cuff area). Saw PCP on 11/7. Has Hx of bad rotator cuff. Pt had prior Pneumovax on 4/13/06 this was unknown to vaccine administrator at the clinic. Pt called on 11/13/06 reports he is back to normal for him. He has chronic pain in that arm and takes pain med regularly.				Y					Y	11/04/2006	11/04/2006	0	NONE	PUB	PUB	Diabetes med and pain meds		Bad rotator cuff, needs surgery.		WA062157	1						1	Hypokinesia; Medication error; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71216~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0618F~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0268752	12/12/2006	VA	84.0	84		F	12/07/2006	Urticaria onset about 4 hours after vaccine. RX Benadryl, than oral Allegra and Ranitadine, No oral				Y						12/06/2006	12/06/2006	0		PUB	PVT		NONE				1						1	Urticaria	FLU3~SANOFI PASTEUR~U2280AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268753	12/12/2006		34.0	34		F	12/12/2006	symptoms occurred about 1.5 week after vaccination from the flu shot. - sensitivity to touch on lower front thigh, wasn't able to wear  clothes on the left leg - muscle pain in hip both pains still exist, and slowly fading. the vaccine given was: vaccin antigrippal VAXIGRIP (DIN 02223929) INFLUVAC (DIN 02269562) not sure which one was given since it was not checked off last year, the same happened, but no muscle pain, only sensitive to touch.  2 years ago, I had the same problem but extrememly worse. sensitivity to touch was unbearable on both legs, muscle pain was excruciating, behind the calves and complete lower waist, these symptoms lasted 1.5 months.				Y					U	11/16/2006	11/22/2006	6	on dec 11, 2006 I went and see my neurologist and he said that it must have been the flu shot. He ruled out neurology. he performed a test, that was with a needle, stinging me from toes to waist and ruled out neurology.	UNK	UNK						1						1	Arthralgia; Myalgia	FLUX~UNKNOWN MANUFACTURER~din02223929~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0268754	12/12/2006	OH	40.0	40		F	12/12/2006	Patient received vaccine on 11/20/06 and experienced mild pain on 11/20-11/21 which went away.  On 11/28/06 patient started having severe pain at injection site.  The pain was severe enough to wake her up at night.  Also a nodule was noted at the injection site.  She reported this to her Safety Officer at the company where she works. (The flu shots had been administered at the company through the health department)  The Safety Officer contacted a health center who recommended heat and exercise.  At the time of interview with the patient on 12/11/06 she reports sx have significantly improved to where she only has a slight ache when moving in certain positions.									Y	11/20/2006	11/28/2006	8		UNK	UNK	Motrin for pain once sx began.  Vitamins	None	None			1						1	Injection site nodule; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA242AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268755	12/12/2006	MD	58.0	58		M	12/12/2006	Client states that friday eve he started with slightly raised red patchy like area on his mid abdomen, buttocks & thighs. Today it is also on his mid and lower arms. He takes prilosec & ibuprofen. He has also ate cookies on friday 11-30-2006 & poss before that were sent to him by his mother from which contain powdered milk which he states he allergic to. States he has been taking benadryl for the itching & hives but no real relief. States no difficulty breathing or swallowing.									U	11/30/2006	11/30/2006	0		UNK	UNK	PRILOSEC long term. Ibuprofen for several weeks for injury.	None	Allergy to milk & client states glutin.			1						1	Pruritus; Rash erythematous; Urticaria	FLU3~SANOFI PASTEUR~U2311AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268758	12/12/2006	MD	46.0	46		M	12/12/2006	5 hours after FluMist administered, patient experienced shortness of breath, wheezing. 12/27/06-records of ER visit received and reviewed. Chief complaint: throat closing. Progress note: most likely possibility seems laryngospasm, unclear etiology. Possible allergy although seemed to have cleared rapidly for this. Doubt mucous as no cough. Seems unlikely that steroids will help.  DC DX: acute stridor, resolved. No treatment provided.				Y					Y	12/07/2006	12/07/2006	0		MIL	MIL	ASA Quinipril HCL Lipitor Protonix		Allergic to Cats and dust HTN Hypercholemia GERD			1						1	Dyspnoea; Laryngospasm; Stridor; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500440P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0268760	12/12/2006	MD	50.0	50		F	12/12/2006	On day of shot, area below shot on arm and continuing to elbow became red and itchy with some large lumps.  Thereafter, to date (one week after shot administration) have developed small numbers of hives each day on various parts of the body, but primarily on face, ears and scalp.  Have taken benadryl and other diphenhydramine products to reduce itching.  Am surprised the reaction has continued this long and has not yet stopped.									N	12/05/2006	12/05/2006	0	none	UNK	UNK	baby aspirin each day	none	none			1						1	Erythema; Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~unknown~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268761	12/12/2006	FL	45.0	45		F	12/12/2006	Over 3-1/2 hour time period after receiving vaccine, developed cough, burning sensation in eyes, throat tightness, facial itching, dizziness.  Reported to Employee Health Center where she was given diphenhydramine 25 mg.   Temperature 98.7, pulse 64, BP 130/70.  Referred to walk-in clinic for medical evaluation and  treatment.				Y					N	12/12/2006	12/12/2006	0		UNK	UNK	Multivitamin, magnesium, vitamin D, coenzyme Q-10, Estroven.	None	Allergic to cats, penicillin.			1						1	Cough; Dizziness; Eye irritation; Pruritus; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601411~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0268762	12/12/2006	CA	1.0	0	.0	F	12/12/2006	beginning 12/10/06, patient bagan getting diffuse spotty bumps over torso and spreading to neck. Prior to rash, Mom states patient ran fever up to 101.5 for 4-5days. Rash was observed and advised to use aveeno bath and/or acetaminophin for discomfort and fever.									U	11/29/2005	12/10/2006	376		UNK	UNK						1						1	Discomfort; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U2220FA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE922AA~4~IM~LL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0818F~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08666E~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0818F~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0268768	12/12/2006					F	12/12/2006	This case was reported by a pharmacist and described the occurrence of loss of left function in a female subject of unspecified age who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis.  The subject's medical history included multiple sclerosis.  On an unspecified date before 07 December 2006, the subject received unspecified dose of Fluarix at an unspecified site of injection. At an unspecified time after vaccination with Fluarix, on an unspecified date before 07 December 2006, the subject experienced loss of leg function and leg numbness. The events resolved on an unspecified date on or before 07 December 2006.  Comment: Loss of leg function was assessed as medically serious. (OMIC)									Y					OTH	OTH					A0631209A	1						1	Hypoaesthesia; Hypokinesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268775	12/12/2006	NC	76.0	76		F	12/01/2006	Within 4 hours after receiving the vaccine she started having pain and weakness throughout her body. She had a stroke several years ago and 5 by pass heart surgery in 2000. Since her husband has the same symptoms, we thought it was from the flu shot and would soon end, but about 8, 11/09/06 she was taken to hospital by rescue squad. 12/19/06-records received and reviewed. DC Summary: Acute non-ST elevation myocardial infarction. Congestive Heart Failure due to Ischemic left ventricular dysfunction Coronary artery disease with previous coronary artery bypass graft surgery Transient ischemic attack with right arm weakness. Hypertension Hyperlipidemia Status post bilateral carotid endarterectomy and cholescyctectomy. Presented to ER with dyspnea and wheezing, flu vaccine 2 weeks ago and had prolonged viral syndrome that she did not seek treatment for. On day of admission developed 2 episodes of right arm weakness and right facial and tongue weakness with slurred speech and she developed sudden dyspnea, orthopnea and wheezing. 12/1/08-copy of death certificate received-COS multisystemic organ failure. Date of death 4/15/08. Information received on annual follow up: Adverse event unrelated to vaccination. Patient has multiple on going health problems. Date of vaccination was 10/27/06 not 11/3/06 as originally reported.	Y	04/15/2008	Y	Y	Y	10			Y	10/27/2006	10/27/2006	0	She had a stroke and heart attack. She continued having same types of illnesses for the next 15 months and heart attacks until 4-15-08 when she passed away after having a brain annurism.	PUB	PVT	Altace, Topril XL, Lexapro , Hydrochlorothiazide, Dynacric CR, Aspirin		She had a stroke and 5 bypass surgery about 7 years ago.		NC06102	1						1	Asthenia; Cardiac failure congestive; Cerebrovascular accident; Coronary artery disease; Dysarthria; Dyspnoea; Hyperlipidaemia; Hypertension; Myocardial infarction; Orthopnoea; Pain; Transient ischaemic attack; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601011~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Results in Death	Influenza
0268778	12/12/2006	IL		51		F	12/12/2006	Arm sore and hurts to raise above her head. This was her first flu shot.									Y	12/06/2006	12/06/2006	0		OTH	PVT						1						1	Hypokinesia; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F602111~1~~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0268779	12/12/2006	KS	0.69	0	.7	M	12/12/2006	Mother states 30 minutes to 1 hour after shot the baby was fussy, so she fed him and the baby took a nap. At 1130, temp was 99, at 1230 PM, temp was 102. The baby was given Tylenol and a cool bath. At 130PM, temp 104 and baby was crying so the mother gave him Motrin and a cool bath. At 230 PM, temp 100. The baby was seen by a doctor. The doctor told the mother it was a reaction to the flu shot. She was instructed to give Motrin and Tylenol alternating every 2hours as needed for temp. The mother states she did this all night, keeping the temp at 100. It remains at 100 today at 1000 AM.									U	12/11/2006	12/11/2006	0		PUB	PVT						1						1	Irritability; Pyrexia	FLU3~SANOFI PASTEUR~U2175~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268780	12/12/2006	WI	25.0	25		F	12/11/2006	Muscle pain with shot resulted in progressed with shooting pain progressing down arm within 2 hours. 3 days of discomfort when moving arm behind body 1 hour. Advil 500 mg started yesterday mild pain still present.				Y					Y	11/21/2006	11/21/2006	0		UNK	PVT	CLINDAMYCIN, BENGAL PERMIEDE, BIRTH CONTROL PILLS					1						1	Discomfort; Myalgia	FLU3~SANOFI PASTEUR~~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268781	12/12/2006	NC	3.0	3		F	11/30/2006	24 Hours after injection on left upper arm, mom noticed area of redness and child scratching. Are is 4 X 81/2 cm with a small amount induration. Mildly tender on palpation.									Y	11/28/2006	11/29/2006	1	NONE	PVT	PUB					NC06103	1						1	Erythema; Injection site induration	FLU3~SANOFI PASTEUR~U2247AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268782	12/12/2006	NC	14.0	14		M	12/07/2006	No adverse reactions per patient's mother. Note: patient had received prior dose of vaccine in October accidentally given second dose.									Y	12/04/2006			NONE	PUB	PUB	ADVAIR, ELIDIL completed 4 weeks ago.	NONE	Asthma		NC06101	1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~U2178AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268783	12/12/2006	NC	68.0	68		F	11/17/2006	Following Pneumovax immunization in left deltoid, raised area 2 1/2 X 3 over left bicep developed, red, warm to touch. Patient self-treated with Benadryl PO presented on 11-17-06 for observation. Referred to PCP who diagnosed cellulitis and treated with IM Rocephin and oral Ceftin.				Y					Y	11/16/2006	11/16/2006	0	NONE	PUB	PUB					NC06100	1						1	Cellulitis; Erythema; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72005~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0618F~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0268784	12/12/2006	NY	9.0	12		F	12/07/2006	Right arm redness and swelling.									Y	12/01/2006	12/03/2006	2		PVT	PVT		NONE	Long QT Syndrome	swollen arm~Influenza (Seasonal) (Fluzone)~~0.00~In Sibling		1						1	Erythema; Swelling	FLU3~SANOFI PASTEUR~U2187AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1049P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268765	12/13/2006		55.0			F		A report was received from a healthcare professional concerning a 55-year-old female vaccinee.  No details concerning the vaccinee's past medical history were provided. On 07/Nov/2006 the vaccinee was administered influenza vaccine (brand unspecified) and Pneumovax 23, 0.5 ml subcutaneously in separate sites (not specified).  In November 2006, the patient was hospitalized for treatment with IV antibiotics because she developed a cellulitis shortly after vaccination.  The cellulitis was unresponsive to oral antibiotics, the vaccinee was discharged from the hospital on 16/Nov/2006.  The event outcome was not provided.  The reporter considered the events to be serious due to hospitalization and also medically significant. (OMIC)					Y	0				11/07/2006				UNK	UNK	Concomitant drugs not reported.				CVOX200600723	1						1	Cellulitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0620F~UNK~SC~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0268776	12/13/2006	AR	37.0	36		M	12/08/2006	Numbness to tongue, fingers and toes. The pts wife contacted me on Dec 8 2006 to obtain information about the flu vaccine manufacturer. I provided her with the information and she told me her husband was hospitalized for 10 days. she said the doctor diagnosed her husband with Gillian Barre related to flu vaccine.Seen in ER for C/O numbness in both hands (fingertips) and both feet with c/o abd pain ongoing times 5 days. ER DX: Left maxillary sinusitis, bilaterally upper and lower extremity numbness, abdominal pain, unspecified.  Labs: WNL.  01/30/07-records received and reviewed from University Hospital of Arkansas for DOS 11/28-12/02/06- DC DX: Resolving mild Guillain-Barre Syndrome HX of Present Illness:complained of bilateral lower extremity weakness with tingling and numbness over tips of toes and fingers started one week ago and has been getting progressively worse. Denies difficulty swallowing for bladders incontinence.  CT of head prior to admission: sinusitis. No treatment.  Information received from the annual follow up indicates patient has not recovered. Patient has been informed by doctor that he has chronic re-occuring symptoms: legs hurt, shortness of breath on exertion, fatigue, swelling on right side of body.					Y	5			N	09/28/2006	11/22/2006	55	EMG:This study does not fulfill electrodiagnostic criteria for clinically suspected AIDP (GBS), however, bilateral demyelinating tibial neuropathies (partial conduction block, relatively prolonged right and left tibial F-wave, slowing of distal tibial CV and A wave on left tibial F-wave) support clinical suspicion. These changes are again mild. Hospital course:CSF: 1 WBC, 55mg/dl protein, 59 mg/dl glucose. No oligoclonal band on the CSF.  CRP and ESR normal LFTs were normal. MRI of brain and C spine for complaint of neck pain was normal. FVC WNL.	PVT	PVT	UNK					1						1	C-reactive protein normal; CSF glucose abnormal; CSF oligoclonal band absent; CSF protein abnormal; CSF white blood cell count positive; Computerised tomogram abnormal; Dyspnoea exertional; Fatigue; Guillain-Barre syndrome; Hypoaesthesia; Hypoaesthesia oral; Muscular weakness; Neck pain; Pain in extremity; Swelling; White blood cell count	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70277~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0268785	12/13/2006	CA	71.0	71		F	11/30/2006	Red, tender rash just above buttocks. Also spreading to inner thigh. Patient states no complaints of pain. Treatment given of Valtrex 500mg 3 times a day for 7 days.  The report we just received following a patient's adverse event to a vaccine is parly incorrect.  Our patient received ZOSTAVAX shingles vaccine on 10/31/06 and reported an adverse event 11/18/06.  She developed shingles about 2 1/2 weeks after receiving the ZOSTAVAX vaccine.  This was confirmed by her internist physician on 11/28/06.  The only other vaccine the patient received with ZOSTAVAX was Influenza vaccine, each vaccine was given in separate deltoid.  There was no complaint of an adverse event following the Influenza vaccine by the patient.  In conclusion the patient had an adverse advent following administration of ZOSTAVAX shingles vaccine.  She was treated and has recovered since.  Please see below for information on the ZOSTAVAX vaccine given to patient on 10/31/06:									Y	10/31/2006	11/18/2006	18	Diagnosis confirmed by another physician in Alaska	PVT	PVT	NONE	NONE	No significant medical illnesses			1						1	Erythema; Rash; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69690~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARZOS~MERCK & CO. INC.~0622F~UNK~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0268810	12/13/2006	AK	59.0	59		F	12/06/2006	Seriousness criteria other medially significant (OMIC). A 59 year old female pt, with no concurrent illnesses, and a past medical history of asthma, diabetes, and allergy to Daypro, Septra, and Rocephin, had received a right deltoid IM injection of Fluzone SV lot number U2283AA, on 11/30/06. Six to eight minutes post immunization, the pt became tomato red, had shortness of breath, blood pressure increased to 210/110, and anaphylaxis. She was treated with two doses of epinephrine for fifteen minutes, IM Benadryl, IM Dexamethasone and oxygen. She was transported to the emergency room where she was observed, and then sent home. Diagnostic tests performed were not reported. The subject had not received any other vaccinations with four weeks of vaccination on 11/30/2006. At the time of this report, the pt had recovered.				Y					Y	11/30/2006	11/30/2006	0		UNK	UNK			The patient had no concurrent illnesses at the time of the vaccination on 30 November 2006.  She has a past medical history of being asthmatic, diabetic, and allergic to Daypro, Septra, and Rocephin.  The patient had no other vaccinations with four weeks of the vaccination on 30 November 2006.		200603335	1						1	Anaphylactic reaction; Blood pressure increased; Dyspnoea; Erythema	FLU3~SANOFI PASTEUR~U2283AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268811	12/13/2006	AR				U	12/06/2006	Initial report received on 01 December 2006 from a health care professional. A patient (demographics not reported), who had no concurrent illnesses, had received a dose of FLUZONE SV '2006-'2007 USP, lot number U2259AA, on an unknown date. Within 24 to 48 hours post-immunization, the patient experienced chest pain and had hypertension. At an unspecified amount of time later, the patient was admitted to the hospital and underwent a cardiac catherization. Reportedly, the cardiac catherization was normal. The reporter for this case is the same as for case 2006-03337.					Y	0			U					MIL	MIL					200603338	1						1	Chest pain; Hypertension	FLU3~SANOFI PASTEUR~U2259AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0268815	12/13/2006	MA	53.0			M	12/08/2006	Initial report received on 04 December 2006 from a health care professional. A 53-year-old male patient, with unknown medical history, had received a dose of FLUZONE SV '2006-'2007 USP, lot number U2184AA on an unspecified date. Reportedly, several hours post-immunization, the patient experienced ventricular tachycardia and a seizure.  The patient was subsequently hospitalized (dates not reported). Treatments received and diagnostic tests performed were reported as unknown.					Y	0			U					UNK	UNK					200603386	1						1	Convulsion; Ventricular tachycardia	FLU3~SANOFI PASTEUR~U2184AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0268816	12/13/2006		24.0			F		A report was received from a healthcare professional concerning a 24 year old female. the vaccinee has a history of splenectomy and penicillin allergy and had no concomitant medications. On 10/27/06 the vaccinee was administered influenza virus vaccine (brand unspecified) at and unspecified site and Pneumovax 23 0.5 ml SC in her left arm. On the evening of 10/27/06 the vaccinee developed a cellulitis like reaction at the injection site. Her left arm became red, swollen and sore and she developed a fever. On 10/28/06 the vaccinee developed shortness of breath, was hospitalized, and diagnosed with cellulitis of the left arm. The vaccinee was treated with an unspecified antibiotic through a PICC line. her white cell count was 46.2 )no units provided) and blood cultures were neg. An MRI of the upper left arm was also performed (no results were provided). The vaccinee was hospitalized for 5 days, and by 11/14/06 she had fully recovered. The reporter considered the events to be serious, immediately life threatening and medically significant (OMIC). The vaccinee had been vaccinated with Pneumovax 23 five years ago with no reported reactions. Further information has been requested.			Y		Y	5				10/27/2006	10/28/2006	1		UNK	UNK	Concomitant drugs not reported.		Splenectomy		CVOX200600722	1						1	Cellulitis; Dyspnoea; Injection site erythema; Injection site oedema; Injection site pain; Injection site reaction; Pyrexia; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1047P~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0268817	12/13/2006		56.0			M		A report was received from a healthcare professional concerning a 56 year old male vaccinee. No details concerning the vaccinee's past medical history were provided. On 11/7/06 the vaccinee was administered influenza vaccine (brand unspecified) and Pneumovax 23 0.5ml SC in separate sites (not specified). It was reported that the vaccinee developed a cellulitis shortly after his recent Pneumovax 23 vaccination, which was treated with oral antibiotics. The event outcome was not provided. The reporter considered the events to be serious, medically significant (OMIC).										11/07/2006	11/07/2006	0		UNK	UNK	Concomitant drugs not reported.				CVOX200600720	1						1	Cellulitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~SC~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268819	12/13/2006	MI	8.0	8		F	11/30/2006	At time of flu vaccine visit, child vomited right after admin in clinic room. Mom stated child had more vomiting. Temp up to 103F, complained of fatigue-went to Emergency Room. Two days later younger sister developed fever, no appetite and the next week the other sister developed fever. Took comment from mother she was not getting second doses of flu vaccine because of these illnesses-that flu vaccine caused them to be terribly ill with nausea, vomiting, fatigue, fever.				Y					Y	10/30/2006	11/01/2006	2		PUB	UNK		Vomited in clinic room	NONE			1						1	Fatigue; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2201BA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268821	12/13/2006	IL	3.0	3		M	12/07/2006	Redness started 12/6. Came back to clinic 1:30pm 12/7. Right lateral upper 1/2 of upper leg indurated-deep pink-13cm circle-warm to touch.										12/05/2006	12/06/2006	1		PVT	PUB		NONE	NONE			1						1	Erythema; Feeling hot; Injection site induration	FLU3~SANOFI PASTEUR~U2283AA~4~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268822	12/13/2006	TN	6.0	5		M	12/12/2006	Within 24 hours, golf ball size red induration evenly around injection site. Patient complained of itching at site of injection. Mother treating patient at home with Benadryl.									Y	12/11/2006	12/11/2006	0		PVT	PVT	Singulair, Claritin	NONE	Sulfa allergy, asthma, perennial allergies			1						1	Erythema; Injection site induration; Pruritus	FLU3~SANOFI PASTEUR~U2271AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268823	12/13/2006	MD	11.0	11		F	12/11/2006	Mother stated child threw up and had a slight fever and had a red mark on right arm.										12/08/2006	12/09/2006	1		PVT	PUB		NONE	Asthma			1						1	Erythema; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2260AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1008P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268824	12/13/2006	VA	53.0	53		F	12/13/2006	I received Influenza IM on Tuesday 11/28/2006. By Saturday I was experiencing a runny nose, congestion with creamy white chunks prn w/cough, body aches, NO fever, and a queasy stomach. I have never had any reaction to past IM influenza vaccines before.  I do have an egg yoke/white intolerance, but have had no respiratory/rash/or anaphylatic problems. I don't eat eggs-upsets stomach.  PMH: NKDA, hemangioma removed as infant, seasonal allergies. MEDS: musinex for congestion and sudafed for clear nasal discharge. No medical treatment with PCP has been arranged by SM at this time. Denies shortness fo breath, chest pain, palpitations, n/v/d, pruritis, headaches or rash/hives/edema. For deployment next month.									Y	11/28/2006	12/03/2006	5	none	MIL	MIL	musinex, sudafed	denies	hx egg yoke/white sensitivity but has had IM influenza w/o problems in past, doesn't eat eggs			1						1	Cough; Nasal congestion; Nausea; Pain; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0268827	12/13/2006	NY	51.0	51		F	12/13/2006	PT. RECEIVED A FLU SHOT 12-12-06 AT 3:45PM AT OUR PUBLIC HEALTH CLINIC (HER HUSBAND ALSO RECEIVED A FLU SHOT AT THE SAME TIME, WITH THE SAME SERUM, AND RECEIVED NO REACTION) WITH IN A FEW HOURS SHE EXPERIENCED A HEADACHE, OVERALL BODY ACHES, FEVER, (DID NOT TAKE HER TEMPERATURE) WAVES OF NAUSEA AND VIOLENT SHAKING FOR AN HOUR AND 45 MINUTES. IT WAS SEVERE ENOUGH THAT SHE HAD HER HUSBAND CALL HER DOCTOR. SHE REPORTED SPINAL STENOSIS ON HER CONCENT FORM FOR A CHRONIC MEDICAL CONDITION, AND HAS HAD MANY PRIOR FLU SHOTS WITHOUT INCIDENT. SHE CALLED THIS MORNING TO SEE IF ANY OTHER PERSON HAD SIMILIAR EXPERIENCES AND REPORTED THAT SHE STILL FELT WEAK AND WASHED OUT BUT BETTER.									Y	12/12/2006	12/12/2006	0	NONE	UNK	UNK	GABAPENTIN 1 PILL DAILY (PT DID NOT TAKE IT THE NIGHT OF THE INCIDENT.	NONE	SPINAL STENOSIS			1						1	Asthenia; Headache; Nausea; Pain; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U2178AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268831	12/13/2006	WY	52.0	52		F	12/13/2006	Evening of vaccination, states that she noticed she was continually clearing her throat. Throat felt sore, scratchy, and on fire. Stated sternum was sore, and hurt to breathe. Stated she called local ER and was advised to just take tylenol and benadryl, and go to bed. States when she woke up this morning, eyes were glued shut, still has sensation of lump in throat, and it feels full of phlegm. Does state that she feels better this morning than she did last night.									Y	12/12/2006	12/12/2006	0		UNK	UNK						1						1	Dyspnoea; Eye discharge; Pharyngolaryngeal pain; Throat tightness	FLU3~SANOFI PASTEUR~U2281AA~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268832	12/13/2006	MO	26.0	26		F	12/06/2006	Asthma like symptoms - wheezing when laying down - throat itching, eyes red and face slightly puffy, slight rash on abdomen.				Y					Y	12/05/2006	12/05/2006	0		UNK	UNK			no spleen		MO200645	1						1	Asthma; Eye swelling; Ocular hyperaemia; Rash; Wheezing	FLU3~SANOFI PASTEUR~U2242AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268833	12/13/2006	MO	0.31	0	.3	M	12/06/2006	Dizzy, vision blurred and cloudy some nausea, some itching.									U	12/05/2006	12/05/2006	0		UNK	UNK	Penicillin VK, Ibuprophen 800 mg.	some flu symptoms	none		MO200646	1						1	Dizziness; Nausea; Pruritus; Vision blurred	FLU3~SANOFI PASTEUR~U2283AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268835	12/13/2006	WI	80.0	80		F	12/13/2006	Redness and swelling injection site to elbow.									Y	12/04/2006	12/06/2006	2		UNK	UNK	Prilosec Verapamil      Avandamet, Pilosec, Verapamil, Hydrochlorothiazide, Potassium Cloride, Cymbalta, Lyrica, Asa, Dicyclomine, Rhinocort, Centrum Silverm, Loperamide and Tramadol	none	DM type 2, peripheral neurapathy, Hypertension, Gerd, Degenerative joint disease/ Rt foot			1						1	Injection site erythema; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72003~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0888F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268839	12/13/2006	WA	52.0	52		F	12/13/2006	SIRS, Developed left arm cellulitis and fever of 103 with delirium and confusion. Rash on lower extremeties and trunk.  1/16/07 Received medical records from hospital which reveal patient admitted 12/13/06-12/15/06.  Patient with known MS presented to ER on 12/12/06 after receiving vax on 12/11/06 with fever & altered mental status.  Noted to be quite delirious, combative & appeared septic in ER.   Temp 103.2.  Pneumovax site was markedly inflamed & indurated.  Had maculopapular erythematous rash on thighs. Treated with antibiotics & steroids & improved significantly. FINAL DX: Systemic Inflammatory Response Syndrome (SIRS); Immune reaction to pneumovax; multiple sclerosis; & delirium, resolved.					Y	2			Y	12/11/2006	12/12/2006	1	Blood culture pending LABS:  CT of brain showed no acute changes.  LP was WNL.  US of LUE showed no abscess.  Cultures were neg.	MIL	OTH	Magnesium gluconate. Interferon 1b. Multiple vitamins with mineral. Vitamin C, vitamin E. Aspirin/caffeine/butalbital. Ativan prn. Detrol. Baclofen. Levothryoid. Provigil. Wellbutrin. Phenergan. Omeprazole.		Multiple Sclerosis PMH: hypothyroidism			1						1	Cellulitis; Confusional state; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U2249AA~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0359~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0268840	12/13/2006	MD	57.0	57		M	12/13/2006	Patient became sore and had muscle aches. Work in engine room on heavy equipment after the flu shot may have contributed. Experiencing a fever and headache.									U	12/13/2006	12/13/2006	0		MIL	UNK	Atenolol, 50 mg.	Had donated a pint of blood the day before at the Blood Bank drive.	High blood pressure.			1						1	Headache; Myalgia; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0268842	12/13/2006		38.0			F		A report was received from a health care professional via another company concerning a 38 year old female vaccinee. On 10/16/06 the vaccinee was administered an Influenza vaccine in her right arm and Pneumovax 23, 0.5ml IM in her left arm. By th evening of 10/16/06, the vaccinee had developed discomfort in her left arm with progressive difficulty in moving it. The injection site was also red painful and tender. On 10/17/06 the left arm discomfort continued, the arm became red and the vaccinee was unable to raise the arm. The vaccinee had also developed a temp of 10.F, sweats and a headache. There were no problems with the right arm at the site of influenza vaccination. On 10/18/06 the vaccinee started vomiting, a CBC was performed, and the vaccinee was called in for examination when the results were returned at 18K. Physical examination on 10/18/06 revealed a temp of 103.3, pulse 130, pulse OX 98, blood pressure 122/70 and a respiratory rate of 14. The vaccinee was diaphoretic, and tachycardia was confirmed. The skin was remarkable for tenderness and a 6cm patch of erythema at the injection site and another 2cm patch of erythema nearby. Investigations revealed a WBC of 18.1 with 85.7% neutrophils and leukocytosis. It was reported that the vaccinee had a febrile reaction to Pneumovax 23 vaccination and that a secondary infection at the injection site could not be ruled out. the vaccinee was commenced on Keflex. the vomiting was considered secondary and was to be treated with Phenegran. On 10/19/06, the vaccinee had a fever of 101\4F, continued vomiting, leukocytosis and a swollen arm. the vaccinee was admitted to hospital on 10/19/06 for left shoulder redness and tenderness consistent with cellulitis. As the symptoms were progressing it was considered that the Cephalexin was not working, so the vaccinee was commenced on IV Clindamycin and Vancomycin. The affected area was now 9x12 and the secondary smaller area was 3cm. the vaccinee white cell count on admission was 22000, T max 101.7 at 1:+1, pulse 105, RR 16, blood pressure 118/73 and oxygen Saturation 99% on room air. Ultrasound of the upper extremity on 10/20/06 showed no evidence of fluid collection or foreign body. As of 10/20/06 the redness had spread a little further but induration and inflammation was reduced. There was no axillary lymphadenopathy, no streaking, and the vaccinee could move her arm more freely. The white cell count was down to 18000, hematocrit down from 35 to 30, glucose 125 and UA showed a specific gravity of 1.031, greater than 300 protein and she remained afebrile from 10/19/06. Incidental findings were a hematocrit of 30 with a MCV of 91 post hydration probably consistent with iron deficiency anemia. The reporter considered the events to serious  other medical event (OMIC). The vaccinee recovered.										10/16/2006	10/17/2006	1	Arterial blood O2 saturation 10/19/06 99, Blood pressure 10/20/06 96 10/15/06 146/72 10/16/06 174/98 10/18/06 122/70 10/19/06 118/73 10/20/2006 113/63, glucose 10/20/06 125, Hematocrit 10/19/06 35 10/20/06 30, Mean corpuscular volume 10/20/06 91, Neutrophil count 10/18/06 85.7%, Pulse OX 10/18/06 98, Respiratory rate measurement 10/18/06 14 10/19/06 16 10/20/06 20, T max 10/19/06 101.7, Temp 10/17/06 103F 10/18/06 103.3F 10/18/06 99.8F 10/19/06 104F 10/19/06 101.7F 10/20/06 100F, total heart beat count 10/18/06 130 10/19/06 105 10/20/06 104, UA 10/20/06 protein greater then 300, Ultrasound 10/20/06 ultrasound of upper extremities showed no evidence of fluid collection, WBC 10/19/06 22000 10/20/06 18000 10/18/06 18.1.	UNK	UNK	ORTHO-CYCLEN, PEPCID AC, PROZAC, SYNTHYROID, ALBUTEROL, MULTIVITAMINS		Pneumonia, Dizziness, PPD skin test positive (received BCG as a Child), C section, lymphadenopathy, gestational diabetes, arrhythmia, atypical organism bronchitis with rhochi (left lower lobe possible infiltration, tonsillectomy, asthma, anxiety, insomnia, vertigo,hypertension, depression, allergic reaction to bee sting, post traumatic stress disorder, drug hypersensitivity, hypothyroidism. Family history of diabetes, heart attack, skin cancer ,hypertension, TIA, hyperthyroidism, GI problems and depression.		CVOX200600719	1						1	Anaemia; Blood glucose increased; Cellulitis; Discomfort; Erythema; Haematocrit decreased; Headache; Hyperhidrosis; Hypokinesia; Injection site erythema; Injection site induration; Injection site infection; Injection site inflammation; Injection site oedema; Injection site pain; Injection site reaction; Laboratory test abnormal; Leukocytosis; Pyrexia; Tachycardia; Tenderness; Vomiting; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268843	12/13/2006					F	12/13/2006	This case was reported by a consumer and described the occurrence of stridor in a female subject of unspecified age who was vaccainted with influenza virus vaccine (Fluarix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Fluarix. On 10/31/06, at an unspecified time after vaccination with Fluarix, the subject experienced stridor, respiratory distress and vocal cord paralysis. Her physician performed a tracheostomy. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the event were unk.									U		10/31/2006			OTH	OTH					A0630663A	1						1	Respiratory distress; Stridor; Vocal cord paralysis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268849	12/13/2006	NY	5.0	4		F	12/13/2006	Swelling noted to Left arm at injection site. No pain, reassurance provided.									U	12/11/2006	12/12/2006	1	NONE	PVT	PVT		NONE	NONE			1						1	Injection site swelling	FLU3~SANOFI PASTEUR~U2280AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268850	12/13/2006	ND	1.97	1	1	M	12/13/2006	Child was in for flu vaccine 12-11/06 approximately 12 noon mother phoned clinic 12-13/-06 related child had a febrile seizure @ 0 PM 12-12-06. Child's last seizure was a year ago after last flu shot mother reported. Was told not to withhold flu vaccine as he underwent testing for his seizure and was found to be normal. This recent seizure was a grand mal lasting 10 minutes. 12/27/06-records received and reviewed. per parent experienced seizure. Temp not recorded. HX of seizure 1/17/2006 after MMR vaccine, temp in ED on 1/17/2006- 104 (R).									Y	12/11/2006	12/12/2006	1	None now. Previous testing because of seizure activity.	PVT	PVT	None	None	Febrile seizures none for 1 year	febrile seizure~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Febrile convulsion	FLU3~SANOFI PASTEUR~U2282AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268851	12/13/2006	CA	48.0	48		F	12/13/2006	Administered 0.5cc influenza vaccine to client on Left deltoid on 12/11/06. On 12/13/06 reports tenderness, redness and warmth at injection site. Denies any itching and other symptoms. Noted light color of redness on Left deltoid about 2x3 inches. No swelling or drainage. Negative for any other reactions.									Y	12/11/2006	12/13/2006	2		PUB	OTH	Lorastatin, Zorlof, Medformen, birth control pill	NONE	Diabetic			1						1	Erythema; Feeling hot; Tenderness	FLU3~SANOFI PASTEUR~U2284AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268852	12/13/2006	MD	54.0	54		F	12/13/2006	Flu shot was given on November 29, 2006 at 10:30am. She comes on December 11, 2006 complaining of arm being numb.									U	11/29/2006	12/11/2006	12		PUB	PVT		injection site sore				1						1	Hypoaesthesia	FLU3~SANOFI PASTEUR~U2186AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268853	12/13/2006	CO	10.0	9		M	12/13/2006	Mom stated child's arm where varicella vaccine was given is swollen and warm to touch. States was worse yesterday (12/12/06) and better today (12/13/06).									Y	12/11/2006	12/12/2006	1	NONE	PUB	PVT	Albuterol, Nasacort, Zyrtec, Loratadine, Advair	NONE	Asthma, allergic rhinitis, sinusitis			1						1	Feeling hot; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70089~4~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARCEL~MERCK & CO. INC.~0915F~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0268855	12/13/2006	CA	3.0	3		M	12/07/2006	1 hour past vaccines patient became hyporesponsive and pale. Mom brought him to clinic. He was saturation 85% room air and was difficult to arouse. His vital were stable and he responded to oxygen. Was transported to the ED where he recovered and was sent home. Normal labs, CXR ? mild RLL infiltrate. The nxt Day he was wheezing and is being treated for an asthma exacerbation. He has asthma. There was no symptoms prior to episode. He was well without any distress.				Y					Y	12/06/2006	12/06/2006	0		PVT	PVT	NONE	Upper resp infection x 3-4 days	Asthma			1						1	Asthma; Chest X-ray; Condition aggravated; Depressed level of consciousness; Laboratory test normal; Lung infiltration; Pallor; Wheezing	FLU3~SANOFI PASTEUR~U2261AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1209F~2~UN~LA~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0268841	12/14/2006	CA	1.0	1	.0	F	12/13/2006	Saturday 12/02/2006: Discovered bumps/rash on legs, trunk. Tuesday 12/05/2006: Rash was worse, spreading to face and arms + bad itching. Brought her to see Doctor. (Dr. said b/c rash was not accompanied by a fever, it was not from vaccine.)  Friday 12/08/2006: Sick, unhappy, tired - crying. Discovered fever of 102-104. Called Doctor who said it was most likely from MMR vaccine and to give her motrin to reduce fever.  Tuesday 12/12/2006: Fever gone, but very cranky, uncomfortable - crying, screaming.				Y					U	11/29/2006	12/02/2006	3		UNK	UNK	none	none	none			1						1	Crying; Discomfort; Fatigue; Irritability; Malaise; Mood altered; Pruritus; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~UNK~~~VARICELLA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0268848	12/14/2006	MO		7		F	12/13/2006	Leg reddened area to left deltoid approx 4 in diameter hot to the touch treated with Benadryl PRN.				Y					Y	11/22/2006	11/22/2006	0		PVT	PVT						1						1	Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U2165BB~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268860	12/14/2006	MN	54.0	54		F	12/13/2006	24 hours after receiving pneumovax. I felt sick chilled, my left arm swelled and was red and hot. Over nite my fever was 101.3. I called telephone nurse, she said to put warm compress, antibiotic cream and report to Dr in am. Urgent care diagnosed cellulitis and put me on Amoxicillin after a shot of antibiotic.				Y					N	12/06/2006	12/07/2006	1	Blood test increased white blood count	OTH	PVT	Atenolol, Ibuprofen, aspirin, Tylenol.	NONE				1						1	Cellulitis; Chills; Injection site erythema; Injection site oedema; Injection site warmth; Malaise; Pyrexia; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~3~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1006P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0268861	12/14/2006	NY	47.0	47		F	12/04/2006	Swelling of left arm with fever, erythema, neck and arm pain. Left arm with 7x10cm area of erythema and induration. Resolving by 12/04/06 treatment with Prednisone and Keflex.				Y					Y	11/29/2006	11/30/2006	1		PVT	PVT	Prozac, Levothyroxine, Advair, Ambien, Spiriva	NONE	Extrinsic asthma, primary hypothyroid.			1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site pain; Neck pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72566~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0620F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0268863	12/14/2006	OH	5.0	5		M		Child passed away 10/18/06. Patient was chronically ill with pontocerebellar atrophy, had shortened life expectancy 1/11/07 Received medical records from hospital which reveal patient admitted 10/13/06 secondary to cardiopulmonary arrest.  Apparently had been in usual state of health & was riding in car w/parent when suddenly became pale with circumoral cyanosis & stopped breathing.  Parent initiated rescue breathing & called EMS who then initiated CPR, intubated & gave epi during transport to outlying hospital before transfer to this Hospital. Made DNR & expired on 10/18/06.  PMH: undefined degenerative neurologic disorder, feeding tube, salivary gland removal.  Hx of previous arrest from respiratory secretions.  Had otitis media 10 days prior to admit tx w/antibiotics.   Birth HX: Adopted.  Normal development till 9 mos of age when lost milestones.  Currently, eyes open spontaneously, non verbal, sits only with support. unable to grasp.  Joint contractures of all extremities. LABS: MRI revealed hypoxic/ischemic event to putamen/caudate (some new), cerebral atrophy & cerebellar degenerative changes.  Trach c/s grew pan susceptible pseudomonas.  Blood & urine c/s all neg.  WBC 12.8 on admit, max of 26.8 on 10/16.  CXR showed LLL density due to atelectasis & collapse. FINAL DX:  None provided. 4/6/07 Received Death Certificate which reveals COD as upper airway obstruction; hypoxic ischemic encephalopathy; cerebral atrophy; and neuromuscular disease (unspecified).	Y	10/18/2006							N	09/26/2006	10/18/2006	22		PVT	UNK		Congestion	CP Pontocerebellar atrophy, brain stem atrophy.			1						1	Cerebral atrophy	FLU3~SANOFI PASTEUR~U2166AB~UNK~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0268864	12/14/2006	OH	27.0	27		F	12/01/2006	On 11/28/06 i woke up around 10pm I could not move my left arm where the shot was given or my left side of my neck on 11/29/06 I went to my doctor for this problem by this time I had a knot on arm where the shot was given and my arm was red and hot, I also had a bad headache. I was off work for 2 days because I couldn't move very well and still had the headache. By 12/1/06 I returned still with some pain but am getting better.				Y					Y	11/27/2006	11/28/2006	1		OTH	OTH		NONE	PCN			1						1	Headache; Hypokinesia; Injection site erythema; Injection site induration; Injection site pain; Injection site warmth; Pain	FLU3~SANOFI PASTEUR~U2239AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268865	12/14/2006	MI	69.0	69		M	12/06/2006	Got Flu shot Mon, and Tuesday got pneumonia same arm site today 12/06 shoulder right sore hurts to move his arm, he is not got redness ore warmth to area, has been using hear advised him to use anti inflammatory Q 4-6, ice to sore area 3-4 x today with movement of arm, ability, when RX has lessened pain. Call tomorrow 12/07/06									Y	12/04/2006				PVT	PVT	NONE		NONE			1						1	Hypokinesia; Injection site pain; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~P72001~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0268866	12/14/2006	MI	46.0	46		F	12/07/2006	Pt here for flu shot am clinic 12/04/06. Reported cough in chest lots  of questions had not gotten flu vaccine in a long time. Prior to vaccine lots of counseling PC from Rt 12/06/06 5:20 pt states 5pm 12/04/06 vomiting several times, chills, weak, stomach upset bloating, diarrhea, chills, headache, muscle aches, miserable, drinking only water. No anti inflammation, referred to medical provider if conditions worsens, fluids tums, anti inflammatory hard hygiene till I talk with her tomorrow, her relative to call if help needed. Tired 12/07/06 3pm better headache tired but tolerated soup, fluids today.									Y	12/04/2006	12/04/2006	0		PUB	PVT	Tegretol, Prozac	Cough in chest	Codeine			1						1	Abdominal distension; Asthenia; Chills; Cough; Diarrhoea; Fatigue; Headache; Malaise; Myalgia; Stomach discomfort; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~P72001~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268868	12/14/2006	OR	1.01	1	.0	F	12/08/2006	Mis administered Zostavax for varicella on 11/15/06 11/22/06 alerted parent, He stated child had no fever, no problems to date 11/23/06 sleeping trouble, fever, headache, wanted to be carried wasn't eating like normal. 6/17/10 This is in follow-up to report(s) previously submitted on 12/14/2006. Information has been received from a registered nurse concerning a 12 month old female who on 15-NOV-2006 was vaccinated SC with a 0.5 mL first dose of varicella-zoster virus vaccine live (Merck) (lot # 652946/1012P) instead of a dose of MMR II (Merck upgrade process). Concomitant vaccination on the same day included an IM first dose on the right thich of FLUZONE (lot # U2175HA) and an IM fourth dose in the right thigh of PREVNAR (lot # B08682E). There was no illness at the time of vaccination. It was noted that there was no product confusion. No medical attention was sought. Additional information was received from the administering nurse who reported that there was no confusion with the packaging. They kept MMR II and varicella-zoster virus vaccine live (Merck) in the freezer together with an intranasal flu vaccine. Occasionally, the flu vaccine would fall onto the other small vaccine boxes. They took the top lid off the boxes so they could easily get to the vials of vaccine. At some point, the boxes got tipped over and someone put the vaccine into the wrong box. The reporter looke for MMR II  in the purple box and grabbed the vial, not realizing that the lid was the wrong color. Essentially, someone put the vaccine in the wrong box and he did not catch it. He realized a week later that the wrong vaccine was given. Additional information has been received from the administering nurse wh on reported that according to the parent, from 23-NOV-2006 to 30-NOV-2006, the patient had a low grade fever, difficulty sleeping, wanted to be held and was not eating normally. After seven days she was back to normal, recovered and doing well. Additional information is not expected.									Y	11/15/2006	11/23/2006	8	Body temp, 12/23/06, low grade fever	PUB	PUB		NONE	NONE		OR200629	1						1	Abnormal behaviour; Body temperature increased; Decreased appetite; Headache; Insomnia; Pyrexia; Wrong drug administered	FLU3~SANOFI PASTEUR~U2175HA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08682E~4~IM~RL~PNEUMO (PREVNAR)~1|VARZOS~MERCK & CO. INC.~1012F~1~SC~RL~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0268871	12/14/2006	CA	4.0	4		F	11/30/2006	Left leg upper thigh red, raised, hot are with very defined border.									Y	11/28/2006	11/28/2006	0		PUB	UNK	NONE	NONE	NONE			1						1	Erythema; Injection site swelling; Injection site warmth	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B069AA~UNK~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70384~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~MERCK & CO. INC.~1008F~UNK~IM~LL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~0823F~UNK~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0268872	12/14/2006	CA	5.0	5		M	11/28/2006	Red and swollen area.									N	11/27/2006	11/28/2006	1		PVT	PVT		NONE				1						1	Erythema; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72220~5~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268873	12/14/2006	CA	4.0	4		M	12/07/2006	12/5/06 Patient received routine vaccines including DTaP IM, left deltoid and MMRV SQ left upper arm SQ. Received IPV, Influenza and Hep A in right arm. Approximately 2pm, 12/7/06 mother noted inflamed, swollen left upper arm. reported to pediatrician and PHN arranged appointment with pediatrician who saw at 10 am 12/7/06. Report from pediatrician indicates left arm 4 cm circumference larger than right, too redness, swelling and pruritic. Treating with chewable Benadryl TID, prn itching.										12/05/2006	12/07/2006	2	NONE	PUB	PUB	NONE	NONE	NKA-NONE			1						1	Erythema; Pruritus; Swelling	DTAP~SANOFI PASTEUR~C2405AA~UNK~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2219AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1067~UNK~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~0823F~UNK~SC~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0268877	12/14/2006	OH	0.36	0	.4	F	12/08/2006	NONE										12/07/2006			NONE	PUB	PUB	NONE	NONE	NONE			1						1	Unevaluable event	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B069AA~2~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2175AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE581AA~2~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B086498~2~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0268878	12/14/2006	MD	32.0	32		F	12/12/2006	On 11-26 7 days after JE vaccine patient stood began to feel like this was really bad used handrail for support. Then had 10 seconds shaking both extremities. Patient awake/aware but unable to stop. Post itch state. No treatment given.				Y					Y	11/21/2006	11/26/2006	5	NONE	PVT	PVT	OCP, MVI	NONE	NONE			1						1	Pruritus; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~FLUA221~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1|JEV~SANOFI PASTEUR~EBN223C~UNK~~~JAPANESE ENCEPHALITIS (JE-VAX)~1|MNQ~SANOFI PASTEUR~4214AA~UNK~IM~~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0268893	12/14/2006		79.0	79		M	12/14/2006	Information has been received from a physician concerning a 79 year old male with unspecified chronic heart disorder and reportedly had well tolerated previous vaccinations who on 27 Oct 2006 was vaccinated intramuscularly in the right upper arm with Pneumococcal 23v polysaccharide vaccine (lot 654243/0049F and Batch ND58630) and was concomitantly vaccinated with secondary suspect therapy Influsplit (lot not reported), intramuscularly in the left arm. three to four days post vaccination the patient experienced enlarged lymph nodes in the right axilla and an enlarged spleen that was enlarged (14 centimeters) in length. At the time of the report it was not reported if the patient recovered. Follow up information has been received. Further investigations revealed that the patient has chronic lymphatic leukaemia. leukocyte count was 63100, among them 77% lymphocytes. The reporter considered that there was no causal link between the event and Pneumococcal 23v polysaccharide vaccine. Upon internal review, chronic lymphatic leukaemia was considered to be an other important medical event (OMIC). No additional information is available. The case was closed. Other business partner numbers included E200605692. Annual followup 01/4/2010 Pt diagnosed with chronic lymphatic leukemia. The reporter considered that there was no causal link between the eent and the pneumovax.									N	10/27/2006	10/30/2006	3	Lymphocyte count 11/06 70%, WBC count 11/06 63100	OTH	OTH	UNK		Immunisation, Cardiac disorder.		WAES0611USA05031	1						1	Chronic lymphocytic leukaemia; Lymphadenopathy; Lymphocyte count increased; No reaction on previous exposure to drug; Splenomegaly; White blood cell count increased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0049F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268894	12/14/2006	CA	16.0	16		M	12/14/2006	On 11/17 pt began having fevers which continued for 2 weeks with sweating and chills. Patient diagnosed with MSSA bacteremia and later found to have a large left hemipelvic abscess. 03/12/07-records received from facility for DOS 12/8-12/20/16-DC DX: Methicillin sensitive staphylococcus aureus bacteremia. Multiloculated left hemi pelvic abscess. Left sacroiliac septic arthritis and extension into spinal canal. Osteomyelitis. Sustained a laceration on his left shin from a desk on 11/13/06. Shortly after, he began to experience mild left lumbar pain that was attributed to muscle strain from basketball practice. Received vaccines on 11/16/06. Developed fever which persisted and pain progressed to include right shoulder and migrated to his left. REceived vaccines in right and left deltoid. Left elbow hot and myalgias grew to encompass his entire body, fevers contined for 2 weeks with maximum temperature 102 at home along with sweating and chills. Nausea, vomiting and diarrhea for 1 week. Postiive localized left groin pain time 1. Lost 23 pounds.					Y	12			Y	11/16/2006	11/17/2006	1	Labs received 3/12/07-Spinal x-ray 11/18/06 negative.  ESR 11/19/06-83. Blood culture staph aureus MSRA positive.  Bone scan 12/4-06-increased uptake in left sacroiliac joint consistent with arthritis or osteomyelitis. MRI 12/6/06-multiloculated left hemi pelvic abscess left sacroiliac septic arthritis and extension into spinal canal at L5-S1.	PVT	PVT						1						1	Abscess; Bacterial infection; Chills; Hyperhidrosis; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500432P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U1920AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2609AA~1~IM~LA~TDAP (ADACEL)~1	USA	Hospitalisation	Influenza
0268895	12/14/2006	AK	37.0	37		F	12/14/2006	Abnormally sore arm, low-grade fever for two days, silver dollar sized red mark (slightly raised: hot) about 1/2 below injection site. Flu shot on Monday, fever on Tuesday and Wednesday.									Y	12/11/2006	12/11/2006	0		OTH	PUB		NONE	NONE		AK200672	1						1	Erythema; Injection site swelling; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U2284AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268896	12/14/2006	IN	56.0	56		M	11/08/2006	Became dizzy about 10-15 minutes after her received the flu vaccine, came to University Health Services. Vital signs P72, R20, B/P 134/84.									U	11/08/2006	11/08/2006	0	NONE	OTH	OTH	VENTOLIN prn, VERAPAMIL, VYTORIN, ASA 81mg, CIPRO (prostate)	NONE known	Grass, Pollen	Vertigo~Influenza (Seasonal) (no brand name)~~54.00~In Patient		1						1	Dizziness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA220AA~1~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268898	12/14/2006	VA	38.0	38		F	12/07/2006	2:00 PM 12/6/06 returned to clinic approximately 3 hours after injection. Complain of SOB, dizziness and fatigability, temperature 98.9, blood pressure 131/104, Pulse 76, Rate 24. Treatment- Bedrest and O2 mask and 10 minutes. PMD doctor notified. Patient declined to hospital seen by doctor 12/7/06. He said I'm fine.				Y					Y	12/06/2006	12/06/2006	0	12/6/06 I was on antibiotic last week.	PUB	PUB	Record as 12/6/06 ALLEGRA, NORADETTE, ALBUTEROL, PULMICORT	Signed form not sick	Asthma-exercise induced, Allergies- Splenda, Susta			1						1	Dizziness; Dyspnoea; Fatigue	FLU3~SANOFI PASTEUR~U2256AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268899	12/14/2006	VA	12.0	11		F	12/07/2006	12/4/06 14 year old female received flu vaccine within 2 min patient starts to seize which lasted approximately 1.5-2 min and then throws herself on her Mom and collapsed.  EpiPen 0.3 mg given right leg IM.  ER notified.  Patient transferred to ER via wheelchair.  12/15/06 Received ER records from hospital which reveal patient began to shake & turned pale within 5 min of flu vax shot.  Admin Epi Pen w/good results but patient felt weak & vision turned black prior to epi.  Taken to ER for observation for 4 hours.  Patient d/c to home on steroids, benadryl & given epi pen for prn use.  Referred for allergy testing. Final Dx: possible allergic reaction to flu shot.				Y					Y	12/04/2006	12/04/2006	0		PUB	OTH						1						1	Asthenia; Convulsion; Hypersensitivity; Pallor; Tremor; Visual disturbance	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71639~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0268900	12/14/2006	TN	46.0	46		F	12/14/2006	Rash over right deltoid area, intense, deep itching interfering with sleep.  Follow-up - symptoms resolved 3/20/07.										10/17/2006	10/24/2006	7	None performed	PVT	PVT	Climara	None known	None	rash, itching~Influenza (Seasonal) (no brand name)~1~0.00~Patient		1						1	Pruritus; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70619~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268902	12/14/2006	WA	13.0	13		F	12/13/2006	None stated.  Follow-up - None - No adverse Rxw - adult vaccine given to child.										11/07/2006				PVT	UNK		NONE				1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601611~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0268903	12/14/2006	WA	10.0	10		M	12/13/2006	None. No adverse event adult vaccine given to child.										11/07/2006				PVT	PVT		NONE	No			1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601611~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0268904	12/14/2006	NC	52.0	52		M	12/14/2006	Patient reported instant burning sensation and pain. Arm (right deltoid) became red, warm to touch, knot at injection site at size of quarter.									Y	12/04/2006	12/14/2006	10		PVT	PVT	NONE currently	NONE known	SULFA, CODEINE			1						1	Injection site erythema; Injection site mass; Injection site warmth	DT~MASS. PUB HLTH BIOL LAB~Td151~UNK~IM~LA~DT ADSORBED (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U2285AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268910	12/14/2006	AR				F	12/14/2006	Patient in office of PCP 12/11/06 in ER 12/10/06 and walk in care clinic with numbness. Referred to facility reported diagnose Guillain Barre. Per information received from annual follow recipeint has 0 impairment per treating doctor-work comp doctor. Claimant may be litigating-against manufactuer due to alleged unknown issues.				Y					Y					OTH	OTH						1						1	Guillain-Barre syndrome; Hypoaesthesia; Dizziness; Swelling	UNK~UNKNOWN MANUFACTURER~~UNK~~~VACCINE NOT SPECIFIED (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA240AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Emergency room visit	Influenza
0268912	12/14/2006	OR	63.0	63		M	12/14/2006	Local tissue pain and swelling.  Several days of chill, fever and generalized pain and malaise.									Y	12/04/2006	12/04/2006	0		UNK	UNK	Hydrochlorothiazide, lisinopril	none	hypertension			1						1	Chills; Malaise; Pain; Pyrexia; Swelling	DTAP~SANOFI PASTEUR~C2341AA~1~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2252AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1008P~1~IM~RA~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~0621F~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0268914	12/14/2006	NM	62.0	62		F	12/14/2006	5 hrs after vaccine given, onset sx of itching eyes, mouth swelling, sore throat. presented to ER following AM w/ sx of headache and facial swelling. tx in  ER with benadryl 50 mg po and decadron 4 mg po and was discharged with decadron 4 mg.				Y					N	12/13/2006	12/13/2006	0		UNK	UNK	MVI qd, Asa 81 mg po qd, Boniva q month (last dose 12/12/06, this was not the first dose)	None	NKDA or food allergies			1						1	Headache; Pruritus; Swelling; Swelling face	FLU3~SANOFI PASTEUR~U2281AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268915	12/14/2006	FL	44.0	44		F	12/14/2006	9/20/05-Received TD vaccine (lot #U1597AA) 10/3/05-Received vaccines listed in box 14 below.  10/4/05-Dizziness lasting 24 hours. 11/7/05-Received vaccines listed in box 13 below. 11/8/05-Dizziness, hallucinations and disorientation lasting for 24 hours. She was seen by PMD and endocrinologist who suggested this was probably due to low blood sugar and not vaccine related.  In April or May of 2006, had a cognitive decline that was not gradual. She regressed and was unable to perform ADL's including dressing and feeding self and had mental slowing. She was evaluated at a Hospital  and in her home country. On 11-17--06 diagnositc impression was encephalopathy that affects the basal gangalion. She will be evaluated at a Clinic on Jan. of 2007. She is improved, but still not able to articulate well and appears slow to process information.  1/2/07 Received medical records from hospital which reveal patient seen in Memory & Cognitive disorders clinic on 7/18/06. HPI: indicates that symproms started 9/05 with unexplained weight loss of about 12 lbs; 10/05 a series of syncopal episodes; 1/06 allodynia, fatigue & malaise, restless leg syndrome;  The consult notes that symptoms started in 9/05 after received vax for a trip to Africa which did not occur.  Developed memory & cognitive problems with an abrupt onset in May/06 with panic type symptoms & insomnia.  Had a recent ear infection & resultant bells ringing in ears.  ALso headaches, trouble walking, weakness, shaking & dizziness.  Neuropsychological exam:  testing at another facility revealed frontal lobe dysfunction w/variable memory problems.  Testing at current hospital also revealed inconsistencies & was unable to provide a Final Dx. Patient out of country 7/19/06 & was to return to US 11 or 12/06.  Further f/u was to be done in foreign country. 1/29/07 Received medical records from Clinic which reveal patient evaluated on 1/8/07 for sudden memory loss, insult to brain & lack of equilibrium/balance since 5/06.  Records from a foreign university  where patient had been evaluated for dementia & records from 1st hospital clinic were reviewed. 1/06 patient dx by rheumatologist with reactive arthritis.  Had pain, nausea, insomnia, burning sensations of legs/feetanxiety attaches which were severe enough to cause patient to go to ER x3.  All symptoms except short term memory loss resolved.  Exam was notable for decreased visual & verbal interaction, hypophonic speech & tendency toward mask like facies.  Impaired smooth pursuits throughout but no cogwheel rigidity or resting tremor.   FINAL DX: Possible static encephalopathy secondary to YF vax. Repeat MRI requested & repeat neuropsychiatric testing to look for possible progressive cognitive inefficiencies.   Additional specialty consultation was requested.  Possible spongiform encephalitis & EEG was ordered to look for rhythmic discharges.				Y				Y	N	11/07/2005	11/08/2005	1	The following tests were negative: HbsAg, Hep B core antibody, hepatitis A antibody, hepatitis C. LABS: MRI of brain done 10/05 was WNL w/questionable angioma in left temporal region.  Possible B12 deficiency. LABS: Foreign MRIs of brain x 2 were done (outside films & report were uninterpretable) but it was thought that bilateral thalamic & basal ganglia were hyperintensities of symmetrical nature.  MRI done at 1st hospital/clinic was not available for review.  Extensive blood work was done & was essentially WNL.	UNK	UNK	Prevacid, Claritin		History of Hepatitis (type unknown)at age 2 PMH: head injury approx 10 years earlier in MVA. ALLERGY:  severe allergy to PCN (cardiac arrest) Family HX:  no hx of dementia			1						1	Blood glucose decreased; Cognitive disorder; Disorientation; Dizziness; Encephalopathy; Hallucination	FLU3~SANOFI PASTEUR~U1910AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~ahabb030ba~2~~~HEP A + HEP B (TWINRIX)~1|TYP~SANOFI PASTEUR~Xo300~UNK~~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Disabling	Influenza
0268916	12/14/2006	ID	1.01	1	.0	F	12/14/2006	Friday November 17, 2006 around 2:00 a.m. I woke up to hear the patient awake. I went into her room and she was laying there with her eyes open. Her body was still and she wasn't alert. She didn't seem to know that I was standing over her bed. I went to pick her up and she jerked back, like a baby does when it thinks it is falling. The patient then went into a full blown seizure.  Her eyes were rolled back into her head and her eye lids were fluttering. Her head as well as her entire body was shaking and jerking. I immediately called 911 and before they got here she was no longer breathing. This all was about a total time of 15 minutes. After arriving at the hospital she had 3 more seizures one of the lasting over 11 minutes. She had a CAT scan done and X-RAY which all cleared as ok. The patient was released on Saturday November 18, 2006 in the a.m. She was discharged on the terms that it was a febrile seizure due to shots. I was told that it was pretty normal and the patient would be alright. The patient returned to her normal routine and seemed to have fully recovered. She had a doctors appointment on Tuesday November 21, 2006 @ 10:30 a.m. MD Said that she was fine had a full recovery. To call if I need anything else. On Monday December 4, 2006 the patient had a normal morning. While I was fixing her lunch I noticed that she seem dazed. She was sitting on the kitchen floor playing on minute, and then the next she was completely dazed. I got down on the floor in front of her and started talking to her. She never responded to anything I said. The patient didn't even look at me. I picked her up and a seizure started again. I laid her on the couch on her side and called MD.  HE said to take her to the emergency room and her would meet me there. The patient's seizure lasted about 5 minutes then I drove here to the emergency room. She was unconscious upon arrival but breathing on her on. While in the emergency room the patient had 4 seizures the shortest one lasting 10 minutes and the longest one lasting 40 minutes. This time the doctors had a hard time getting them to stop. The patient wasn't breathing on her own. We were in the emergency room for over 6 hours before she was stable enough to go to a private room. She under went another CAT scan and X-ray. Which both were fine. She had an EEG which wasn't ok. But due to medication and seizures we knew that it wouldn't be. On Tuesday November 5, 2006. The patient had an MRI, which check out to be ok. Another EEG did not show that she was ok. Tuesday the patient still didn't know who I was or her Father. One other strange thing was the patient wasn't running a fever at the time of any of her seizures but started running one during the time of her hospitalization. On Wednesday  November 6, 2006 the patient was Released in the a.m. from the hospital. She was diagnosed with epilepsy and put on Dilantin every 8 hours. The Doctors are now saying that this had nothing to do with her shots. The patient was a perfectly normal little girl who had never been sick, before she had these shots. Her first set of seizures occurred within 12 hours of her shots. Through research I have done and everything that happened as it did within the timeline of her shots I am at full belief that her vaccines had everything to do with her condition now.  1/9/07 Received medical records from hospital which reveal patient admitted twice: 1. 11/17-11/18/06 -- D/C Diagnosis was complex febrile seizure.  Had 2 witnessed seizures at home of approx 2 min each.  In ER was post ictal then had multiple witnessed seizures in ER.  No further seizue act since ER which resolved with valium & ativan.  No antiepileptics rxd.  2. 12/4-12/6/06 D/C Diagnosis was seizures.  Had nonfebrile generalized tonic clonic seizure lasting approx 1 hour.  Received valium & ativan which resolved seizure.  Loaded with Fosphenytoin & was admitted to floor.  Neuro consult obtained.  D/C home on dilantin & to f/u with neuro.				Y	Y	3		Y	N	11/16/2006	11/17/2006	1	2 Cat scans: normal, 2 X-rays: normal, 2 EEG's: negitive, 1 MRI: normal. A lot of blood work: normal, 2 cultures: Negative 11/17-11/18/06 LABS: CXR was WNL.  WBC 24.2, segs 41, bands 2, lymphs 42, monos 11, eos 4.  SGPT 35, Alk Phos 256.  Blood c/s neg.  CT of head WNL.  12/4-12/6/06 LABS: all considered WNL.  WBC 11.7.  CT of head WNL.  EEG was considered WNL.   Blood c/s grew strep viridans which was felt to be contaminant.	UNK	UNK	none	none	none			1						1	Coma; Convulsion; Dyskinesia; Epilepsy; Eye movement disorder; Tremor	FLU3~SANOFI PASTEUR~UT2176KA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1015F~4~IM~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0861F~1~SC~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|PNC~PFIZER\WYETH~B08674K~3~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0914F~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Hospitalisation,Disabling	Influenza
0268919	12/14/2006	MN	42.0	42		F	12/14/2006	Rash and itching on arms within two hours of vaccine.  Itching on legs within 12 hours.  Itching on palms of hands and soles of feet within 24 hours.  Swelling of hands and feet within three days of vaccine. Numbness and tingling of hands, legs and feet within four days.  Numbness has subsided but still some tingling right away in the morning and still some swelling of hands and feet.									N	12/05/2006	12/05/2006	0	None	UNK	UNK	Levoxyl	None	Penecillin IV Contrast Dye			1						1	Hypoaesthesia; Oedema peripheral; Paraesthesia; Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA221AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268920	12/14/2006	VA	64.0	63		F	12/14/2006	This 64 year old retired military family member received her yearly IM influenza vaccine on 19 October 2006. She reported being in good and stable health despite numerous medical conditions being able to function independently working 6 hours a day as a FNP at a health center. She would walk @ 2 times a week 3-4 blocks slowly due to requiring home oxygen use.Over the next few weeks her muscular aches worsened from a 1-2/10 onset to 2-3/10 without resolution. By the third week post vaccination her discomfort was now 5-6/10 with increasing pains to all joints. She self adjusted her Relafen to 2 tablets twice a day for one week. She described this pain as a dull to spastic-sharp zap that was most searing to her lower back ... specifically the right SI joint and sacral area. Over the Thanksgiving holiday her pain progressed to where she could not cook and was limited to sitting in a chair watching family events she use to participate in. She returned to work stating she hurt but it was not depilating.  By Tuesday 11/30/06 she complained of being run over by a mack truck with searing pain all over her body...especially her back.  She saw MD December 1, 2006 for multiple myalgia/arthralgia and now new onset of right upper quadrant pain with decreasing appetite due to the pain.  He diagnosed her with arthralgia with normal labs (3 WBC in us, neg culture, BS 140, H1AC 8.9, RUQ ultrasound wnl with chronic fatty liver).  She was placed on titrating Prednisone 60 mg decreasing 5 mg/day and Vicodin for pain.  She was re-evaluated by MD on 11 December 2006 where she reported being better but still in pain.  She can now ambulate @ 15 minutes before hurting and is receiving physical therapy TID.				Y					N	10/19/2006	10/22/2006	3	none known	UNK	UNK	Vitamin E 400 IU qhs MVI daily Caltrate 600mg BID w/Vit B Glucosamine 500 mg w/Condrointin 400mg TID Trivita B12 daily Potassium 20 mEq daily Tambacor 100 mg bid Ismol 20 mg bid Deltizam 120 mg qhs lisinopril 10 mg qhs lasix 80 mg qam and 4	no acute illnes, see multiple chronic medical conditions	Type II diabetes atrial fibrillation congestive heart failure ashtma (since child) GERD glaucoma VonWillabrand disease hypertension anemia (nose bleeds) Pulmonary fibrosis secondary to amiodrone use (d/c'd) obesity arthritis panic attacks/nightmares secondary to hx child abuse MVP/pulmonary stenosis  hx pneumonia/bronchitis Hx right knee injuries s/p fall Hx fractured right toe x 2, nose and right patella? @ 2000-2001 s/p fall Hx Full thyroid Hx Basal cell CA on right side face removed 15 years ago			1						1	Arthralgia; Back pain; Decreased appetite; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0268921	12/14/2006	MD	52.0	52		F	12/14/2006	11/5/06 Tingling in hands, leg weakness, arm grip weakness, back pain, leg pain, chest discomfort with shortness of breath, facial numbness.  Hx of Chronic Obstructive Pulmonary disease Hx thyroid takes synthroid Vital Capacity decreased and intubated and later required tracheostomy.Pt is currently in rehab. facility Pt also was noted to have a cerebrospinal fluid Lyme antibody positive and placed on Rocephin 2 gm IV q 24hr x 3wks. 12/21/06-records received and reviewed for DOS 11/7/06-12/2/06 DC DX: Guillan Barre syndrome respiratory failure requiring intubation secondary to Guilland Barre syndrome status post tracheostomy leukopenia secondary to Neurontin positive cerebrospinal fluid for Lyme serology Panic disorder chronic back pain history of old tobacco usage history of chronic obstructive pulmonary disease.  MRI of head: multiple sulci with increased flare and T2 signal throughout the pervitricular white matter which was nonspecific.  MRS: showed no significant stenosis, aneurysmal dilation or vascular malformation. LP: protein: 106.5, IgG was 15.8 Trach placed after extubation. TX: IV immunoglubulin G. Noted increasing strength of her lower extremities.  CSF: lume antibody reactive  CSF cultures: negative, all other cultures negative ANA >5 WBC 2.9.			Y	Y	Y	28	Y	Y	N	10/26/2006	11/05/2006	10	Lumbar puncture - elevated protein 106.5  cerebrospinal fluid IgG was 15.8 CSF: lume antibody reactive  CSF cultures: negative, all other cultures negative ANA >5 WBC 2.9. leukopenia secondary to Neurontin positive cerebrospinal fluid for Lyme serology	UNK	UNK	Synthroid	None	Pt indicated thyroid. Medical records show Hx chronic obstructive pulmonary disease			1						1	Back pain; CSF test abnormal; Chest discomfort; Dyspnoea; Guillain-Barre syndrome; Hypoaesthesia; Hypoxia; Laboratory test abnormal; Leukopenia; Muscular weakness; Pain; Panic reaction; Paraesthesia; Respiratory failure	FLU3~SANOFI PASTEUR~U2286AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0268922	12/14/2006	IN	51.0	51		F	12/14/2006	Vaccine given 11/10/06.  Within 12 hours, pt. was in severe pain at the site of the injection (upper rt. arm).  The pain was intense, at a 9/10 level on a 10-pt. scale.  The pain would decrease to a 5/6 level off and on.  This continued for 3 weeks, with no relief from prescriptions for Vicodin nor Ultram. Please note:  I do not know the name of the flu vaccine I received, so the guess in box 13 may well be incorrect. As the weeks continued, the pain progressed from the upper rt. arm to the rt. shoulder, across the back, up the neck, and into the left shoulder.  Pain continued varying from 5/6 to 9/10 with no discernable pattern or causation. Now in the fifth week, the pain has diminished to a consistent level 4/5.  I (the pt.) am taking up to 1800 mg. Ibuprofen daily. There never was any outward sign of trauma, no redness, swelling, hives, etc.  An MRI (rt. arm) produced 3 1/2 wks. after the injection was negative. Neither my family physician nor my neurologist could determine any cause other than the apparent vaccine.				Y					N	11/10/2006	11/11/2006	1	MRI: negative Blood work:  negative	UNK	UNK	Flovent, aspirin, Cymbalta, Celebrex	None	Allergies:  many environmental (dust, pollens, dander, etc.) and foods  Allergic rhinitis Monoclonal gammopathy of undetermined significance Neurological symptoms, including prior surgery for Chiari Malformation I			1						1	Injection site pain	FLUX~UNKNOWN MANUFACTURER~~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0268923	12/14/2006	PA	56.0	56		F	12/14/2006	Outbreak of Eczema on Arms, legs, torso. Although this is not life threatening, it is something that I have not experienced for 40 years.   Not sure if it is side-effect or a coincidence. Thought you would be interested in knowing this  information for your records.				Y					U	12/06/2006	12/06/2006	0		UNK	UNK		none	Eczema last occurrance 40 yrs ago			1						1	Condition aggravated; Eczema	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0268924	12/14/2006	TX	9.0	9		F	12/14/2006	TWENTY MINUTES AFTER RECEIVING IMMUNIZATIONS WAS TAKEN FROM CLASSROOM TO THE SCHOOL NURSE COMPLAINING OF A LITTLE HEADACHE AND DIZZINESS. BP=100/58. NO SHORTNESS OF BREATH OR DIAPHORESIS.HAD PATIENT LYING DOWN ON TABLE IN THE NURSE'S OFFICE. STATED SHE FELT A LITTLE BETTER. GIVEN WATER AND MOTHER CALLED. MOTHER CAME AND TOOK DAUGHTER HOME. PATIENT DENIES ANY BAD SYMPTOMS AFTER GETTING THE SHOTS BUT FELT BAD TWENTY MINUTES LATER AND REPORTED IT TO HER TEACHER.									Y	12/14/2006	12/14/2006	0		UNK	UNK						1						1	Dizziness; Headache	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72005~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB261AA~UNK~~~HEP B (ENGERIX-B)~1|IPV~PASTEUR MERIEUX CONNAUGHT~Z0001~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1	USA		Influenza
0268926	12/14/2006	NJ	7.0	7		F	12/14/2006	within 2 days of injection, patient developed a large area of erythema and tenderness extending from shoulder to fleural crease of the elbow. Patient needed admission and iv clindamycin. She had fever to 102.6 at the time of admission. she remained in the hospital for almost 48 hours. 12/27/06- records received and reviewed for DOS 12/7-12/8/06 DC DX:cellulitis  right arm swollen red. temp 39					Y	2			Y	12/05/2006	12/07/2006	2		UNK	UNK	flovent (110) Zyrtec 7.5 mg singulair 5 mg albuterol MDI 90 mg	no	asthma allergic rhinitis			1						1	Cellulitis; Erythema; Pyrexia; Swelling; Tenderness	FLU3~SANOFI PASTEUR~u2284aa~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0268928	12/14/2006	WA	63.0	63		F	12/14/2006	Large area of ecchymosis beginning within 1-2 days of injection.  Now at 1 month from injection has persistent aching pain and tenderness in triceps and deltoid muscles underlying injection site.  No palpable mass, abscess or other abnormality.  No neurologic changes in arm									U	11/09/2006	11/11/2006	2		UNK	UNK	Triamterene/HCTZ Prevacid	None	GERD Hypertension Hypercholesterolemia			1						1	Ecchymosis; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601211~7+~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0268929	12/14/2006	CA	4.0	4		M	12/14/2006	REDNESS OF RIGHT DELTOID WITH INDURATION AND WARM TO THE TOUCH.									U	12/13/2006	12/14/2006	1		UNK	UNK		NONE, HEALTHY VISIT	BRONCHIOLITIS 2/26/03,4/21/03,12/30/03 TONSILITIS 5/15/03 OTITIS MEDIA 12/30/03			1						1	Injection site erythema; Injection site induration; Injection site warmth	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14BO35AA~5~IM~RA~DTAP (INFANRIX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71032~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~Y0298~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0258725	12/15/2006	OK	43.0			M	10/02/2006	Initial report received on 22/Sep/2006 and 25/Sep/2006 from the agency. A 43-year-old male patient with no current illnesses, but who was taking ibuprofen, Ambien and Vicodin had received a dose of Menatra, Influenza vaccine, Yellow Fever vaccine, Poliomyelitis Inactivated vaccine, Typhoid vaccine, Hepatitis A vaccine, and Measles Mumps and Rubella vaccine on 02/Jun/2006. The trade names, manufacturer names, lot numbers, routes and sites of administration were not reported. Eleven days post-immunization, on 13/Jun/2006, the patient felt like there was a mass in his throat, then he had numbness in his fingers and toes. Subsequently, the patient started having difficulty in his gait that was followed by weakness making him unable to lift weights in the gym. Seven days later, on 20/Jun/2006, the patient was hospitalized and treated with IVIG and a dose of Prednisolone. An MRI scan was normal,and per the reporter the patient had RBC'S O, WBC's 2, protein 100, and glucose 64. The patient had an IGG level 6/2 IVP in am. The patient had received a dose of Hepatitis B vaccine, four weeks prior to administration of vaccines on 02/Jun/2006. The trade name, manufacturer name, lot number , route and site of administration were not reported. At the time of this report,the patient had not recovered from the adverse events. As per the agency this case was confirmed by CISA as being Guillain Barre Syndrome following Menactra vaccine. Follow-up information received on 27/Sep/06 from the agency. The Hepatitis A vaccine and Hepatitis B vaccine that was administered was identified as Twinrix,manufacturer reported, lot number not reported. The patient had been examined in an emergency room on 18/Jun/2006. He was hospitalized from 19/Jun/2006 to 26/Jun/2006. At the time of discharge from the hospital, the patient had increased strength and was able to return home.					Y	8			N	06/02/2006	06/13/2006	11		PUB	PUB	Ibuprofen, Ambien, Vicodin				200602489	1						2	Asthenia; Gait disturbance; Guillain-Barre syndrome; Hypoaesthesia; Movement disorder; Throat tightness; Asthenia; Gait disturbance; Guillain-Barre syndrome; Hypoaesthesia; Throat tightness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~HEP A + HEP B (TWINRIX)~1|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|MNQ~SANOFI PASTEUR~~UNK~~~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|YF~UNKNOWN MANUFACTURER~~UNK~~~YELLOW FEVER (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~HEP A + HEP B (TWINRIX)~2|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~2|MNQ~SANOFI PASTEUR~~UNK~~~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~2|YF~UNKNOWN MANUFACTURER~~UNK~~~YELLOW FEVER (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0268930	12/15/2006	RI	47.0	47		F	12/12/2006	Seriousness criteria other medically significant (OMIC). Initial report received on 05 December 2006 from a health care professional. A 47 year old female patient, with a history of food induced anaphylactic reactions, and who was taking Prednisone, Albuterol and Zyrtec, had received a dose of Fluzone on 27 November 2006 at 11:00 pm. The lot number, route and site of administration were not reported. Twenty minutes post immunization, at 11:20 pm, the patient experienced chest tightness, shortness of breath, and spasmodic coughing. The patient was administered Adrenalin, and transported to the emergency room via rescue EMS where she was treated and released. Treatments received, and diagnostic tests performed were not reported. At the time of this report, the patient had not recovered. A corrective version (1), (with the same latest received date as the previous version), was generated in order to amend the category in this case as serious, category II, for reporting purposes.				Y					N	11/27/2006	11/27/2006	0		UNK	UNK	PREDNISONE, ALBUTEROL, ZYRTEC		The patient did not have any illnesses at the time of the vaccination on 27 November 2006. She has a past history of anaphylactic reactions that have been food induced.		200603388	1						1	Chest discomfort; Cough; Dyspnoea; Muscle spasms	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0268931	12/15/2006	PA	5.0	5		M	12/12/2006	Initial report received on 07 December 2006 from a health care professional. A five year old male patient, with a history of asthma, and who was taking Albuterol and Claritin, had received a first dose, right deltoid injection of Fluzone, lot number U2239AA, on 20 September 2006. The route of administration was not reported. The patient was seen in the physicians office 29 days post immunization for his second Fluzone injection. The second dose was not given as the patient was noted to have a skin rash on his legs, arms, abdomen and had minor hematuria. The patient was diagnosed with Henoch Schonlein purpura and was hospitalized four days later, on 23 October 2006. The patient was treated with oral and IV antibiotics. He was hospitalized for two days. At the time of this report, the patient had recovered.					Y	2			Y	09/20/2006	10/19/2006	29		PVT	PVT	Albuterol, Claritin		The patient denied any concurrent illnesses, and having had any other vaccinations within four weeks of the vaccination on 20 September 2006. He has a past medical history of asthma.		200603403	1						1	Haematuria; Henoch-Schonlein purpura; Rash	FLU3~SANOFI PASTEUR~U2239AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0268934	12/15/2006		44.0			U		A report was received from a healthcare professional on 05 Dec 2006, concerning a 44 year old vaccinee (sex unspecified). No details concerning the vaccinee's past medical history or concomitant medications were provided. The vaccinee was administered Fluvirin 0.5ml by intramuscular injection on an unspecified date, the vaccinee then developed arm pain, and was subsequently diagnosed as having brachial neuritis. The reporter considered the event to be serious, hospitalisation and disability/incapacity. The events are ongoing. Further information is requested.					Y	0		Y	N					UNK	UNK	Concomitant drugs not reported.				CVOX200600734	1						1	Pain; Radiculitis brachial	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70279~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0268935	12/15/2006		32.0			U		A report was received from healthcare professional on 04 Dec 2006, concerning an unidentifiable vaccinee. The reporter stated that 6 or 7 employees experienced swollen tender arms, with difficulty elevating the arm for weeks after the vaccination. Further information will be requested. Follow up received from a healthcare professional on 05/Dec/2006, identified the vaccinee as a 32 year old. No details concerning the vaccinee's past medical history or concomitant medications were provided. The vaccinee was administered Fluvirin 0.5ml by intramuscular injection on an unspecified date, developed an acute painful arm for 3-4 weeks and was subsequently diagnosed as having brachial neuritis. The reporter considered the event to be serious, hospitalisation and disability/incapacity. The events are ongoing. Further information is requested.					Y	0		Y	N					UNK	UNK	concomitant drugs not reported.				CVOX200600728	1						1	Pain; Radiculitis brachial	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69480~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0268936	12/15/2006		33.0			U		A report was received from a healthcare professional on 04/Dec/2006, concerning a vaccinee (no identifiers provided). No details concerning the vaccinee past medical history or concomitant medications were provided. The vaccinee was administered Fluvirin on an unspecified date, and was subsequently diagnosed as having brachial neuritis. Follow up information was received from a health care professional on 05/Dec/2006. the vaccinee has been identified as a 33 year old, who received 0.5ml of Fluvirin by intramuscular injection. The vaccinee has still not recovered. The reporter considered the event to be serious, hospitalisation and disability/incapacity. Further information will be requested.					Y	0		Y	N					UNK	UNK	Concomitant drugs not reported.				CVOX200600731	1						1	Radiculitis brachial	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69480~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0268937	12/15/2006		64.0	64		F		A report was  received from a health care professional on 05/Dec/2006 concerning a 64 year old female vaccinee. No details of the vaccinee's past medical history or concomitant medications were provided. The vaccinee received Fluvirin by intramuscular injection on 12/OCT/2006. On 05/Nov/2006 she began complaining of low back pain, which spread up to her mid back over 1.5 weeks. The pain was severe, and on 11/Nov/2006, the vaccinee developed tingling in her hands when reaching out. the vaccinee was seen by a neurosurgeon, but no cause was found for the pain. the vaccinee had no pain control with Lorcet, Lortab , Demerol and Pnenergan. She was then admitted to hospital and commenced on a Morphine pump which provided some pain relief. By this time the vaccinee had had 10 MRI and CT scans with no results. A CT of her chest revealed ataletasis secondary to not breathing deeply due to the pain. On 27/Nov/2006, the neurologist performed nerve conduction studies, which revealed inflammation of the nerve roots, the vaccinee's physician considered this to be caused by either a virus or immunisation. Further information is requested.					Y	0				10/12/2006	11/05/2006	24		UNK	UNK	Concomitant drugs not reported.				CVOX200600732	1						1	Atelectasis; Back pain; Inflammation; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70249~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0268938	12/15/2006		42.0	42		F		A consumer report was received on 04/Dec/2006. concerning a 42 year old female vaccinee. No details concerning the vaccinee's past medical history or concomitant medications were provided, but the vaccinee has no known egg allergy. On 16/Oct/2006 the vaccinee received Fluvirin by intramuscular injection. 17 minutes later she began wheezing, and she was given Epinephrine, admitted to hospital and discharged later that day. The vaccine continues to experience muscle stiffness, joint pain, swollen hands (especially the right index finger) and shortness of breath (onset date not specified). Further information will be sought.					Y	0			N	10/16/2006	10/16/2006	0		UNK	UNK	Concomitant drugs not reported.				CVOX200600726	1						1	Arthralgia; Dyspnoea; Musculoskeletal stiffness; Oedema peripheral; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71353~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0268939	12/15/2006		40.0			U		A report was received from a healthcare professional on 05/Dec/2006, concerning a 40 year old vaccine (sex unspecified). No details concerning the vaccinee's past medical history or concomitant medications were provided. The vaccinee was administered Fluvirin 0.5ml by intramuscular injection on an unspecified date at the end of September, and was subsequently diagnosed as having brachial neuritis. The reporter considered the event to be serious, hospitalisation and disability/incapacity. The events are ongoing. Further information is requested.					Y	0		Y	N					UNK	UNK	Concomitant drugs not reported.				CVOX200600733	1						1	Radiculitis brachial	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70279~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0268940	12/15/2006	GA	66.0	66		M	11/29/2006	Immediate numbness in both legs (especially feet), pelvic region and back pain after receiving a flu shot. Increasing leg weakness resulting in hospital admission on 11/05. ICU and mechanical ventilation on 11/08. Plasmaphersis-11/22, IVIG-11/09, diagnose: probable Guillain- [[name]] Syndrome.  2/16/07 Received medical records from hospitalization from 11/5/06-1/12/07 which reveal patient experienced numbness of LEs from umbilicus down, low back pain & leg weakness & recurrent falls beginning almost immediately after receiving flu vax.  Seen in outlying ER & transferred to higher level care facility.  Exam revealed mild weakness of dorsiflexion bilaterally.  DTRs absent.  Diminished pinprick of LEs.  Sitnificant ataxia on finger to nose testing.  Difficulty sitting w/o support due to truncal ataxia.  Unable to stand due to severe ataxia. Declined on 3 days & required intubation.  Tx w/IVIG but continued to decline rapidly & developed flaccid quadriplegia, areflexia, bifacial weakness w/incomplete eye closure, dificulty w/[[name]] movement & tongue control.  Plasma exchange done but continued to deteriorate.  Second course of plasma exchange done & patient did improve.  Transferred to rehab hospital. Follow up EMG in 12/06 revealed severe GBS w/axonal features.  No EMG reports included.  T/C to hospital to request same. FINAL DX: Guillain [[name]] Syndrome; HTN; hyponatremia; respiratory failure; s/p trach & PEG tube; exposure keratoconjunctivitia; depression; and porrible perianal fistula. 2/22/07 Received EMG/NCS reports of 11/8/06 which revealed results c/w gen peripheral neuropathy which was neither axonal nor demyelinating in nature; report of 12/13/06 revealed evidence of a severe generalized sensorimotor peripheral neuropathy w/ a component of axonal degeneration. Follow-up: At the time of discharge from the hospital (1/12/07) patient still demonstrated flaccid quadriplegia and areflexia requiring ventilation support, but did not show improved pupillary response, eye movements, and tongue / [[name]] movement.			Y	Y	Y	18	Y		N	10/25/2006	10/26/2006	1	11/7 CSF Glu 78, Protein 78, WBC 6 (Neut 50%, Lymph 33%, Mono 17%), Monospot neg, CBC wnl, K3.4, MRI spine nerve root enhancement of cauda equina.  LABS: MRI of brain & TL spine were all WNL but w/DDD.  Initial EMG finding were consistent with polyneuropathy.  LP under fluoro revealed glucose 78 & protein 78, all c/s were neg.  Serial CT scans were WNL. Information received from the annual follow up indicates patient had not recovered. Flaccid quadriplegia & areflexia during entire hospital stay. Ventilator dependent. Pt transfered to select specialty hospital in an attempt to wean from ventilator.	PVT	OTH	LISINOPRIL 20mg, HCTZ 25mg, METOPROLOL 50 mg		Uncontrolled Hypertension PMH: HTN, cigarette & ETOH abuse (stopped both 20 yrs prior)			1						1	Anal fistula; CSF glucose; Depression; Dyskinesia; Dysstasia; Eye disorder; Full blood count; Guillain-Barre syndrome; Hypoaesthesia; Hyponatraemia; Hypoxia; Keratitis; Muscular weakness; Neuropathy peripheral; Paresis; Protein total; Respiratory failure; Tongue disorder; Tracheostomy; White blood cell count	FLU3~SANOFI PASTEUR~U2238AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0268944	12/15/2006	LA	86.0	86		F	12/15/2006	Patient complain of heaviness in tongue about 20 minutes after injection and sensation of labored breathing. Patient maintained adequate saturation  (>98%) did have any objective finding consistent without anaphylatoid reaction. Patient given ice and Celestone and closely followed totally abated within 1 hour.									Y	12/13/2006	12/13/2006	0	NONE	PVT	PVT			Allergy to Codeine, history: HTN, CAD, GERD			1						1	Dyspnoea; Sensory disturbance	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71830~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268946	12/15/2006	MT	45.0	44		F	12/10/2006	4 days worse, 1st 2 days bodyaches, headache (base of skull) low grade fever 99.5 degrees- 100.5 F, loose stools 1-2 days, hyperactive bowel stones.									Y	12/06/2006	12/07/2006	1	NONE	OTH	PVT	NONE	NONE	URI-treated with 5 day Z pack-last dose on 12/02/2006.			1						1	Diarrhoea; Headache; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72008~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268947	12/15/2006	FL	17.0	17		M	11/17/2006	Noticed slight red rash around injection site 11/17/06 6:30 am complain slight nausea.									Y	11/15/2006	11/17/2006	2		PVT	PVT		NONE	NONE			1						1	Injection site erythema; Injection site rash; Nausea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71829~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268948	12/15/2006	MT	38.0	38		F	12/04/2006	On 12/1/06 patient had immunization Flumist, left arm had small amount of soreness at injection site on 12/1. 12/2 increase soreness with small red spots at injection site. 12/3 Difficulty sleeping  related to arm pain, increase redness, muscle aches, low-grade temperature. Later in night had vomiting, increase achiness, nausea, swelling et 2 x 2 redness at site. 12/4 increase soreness, increase redness (3 x 4), increase swelling, warm, tender continues to feel achy. Vital signs on 12/04/06 100/76, 99.4 oral, Pulse=104. Patient given Tylenol #3 for pain and fever.				Y					U	12/01/2006	12/04/2006	3		PVT	PUB	Acipherex 20 mg QD, Birth Control Patch, Calcium	Healthy	NONE			1						1	Body temperature decreased; Injection site erythema; Injection site swelling; Injection site warmth; Insomnia; Myalgia; Pain; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500436P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|PPV~MERCK & CO. INC.~0889F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0268949	12/15/2006	VA	81.0	81		M	12/11/2006	Developed shingles.				Y					N	11/13/2006	11/23/2006	10		PUB	UNK		NONE	NONE			1						1	Herpes zoster; Infection	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0268950	12/15/2006	CA	22.0	22		M	12/07/2006	As she left to go to her car noticed that her tongue felt odd and hurt to swallow so came back in to office, no SOB, no numbness, no tingling, no wheezing. Sensation mainly at base of tongue and in salivary glands, sublingual. Patient given Zyrtec 10 mg and observed, O2 saturation 100, Pulse 68 after domain. No signs/symptoms patient allowed to go home.									Y	12/07/2006	12/07/2006	0		PVT	UNK		Allergic rhinitis				1						1	Dysphagia; Tongue disorder	FLUN3~MEDIMMUNE VACCINES, INC.~500429P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0268951	12/15/2006	NH	47.0	47		F	12/11/2006	Heavy soreness to right arm-pain started Friday evening. Rectangle shaped rash around injection. Swelling of injection site. All started the evening of injection. Symptoms subsided today 12/11/06.									Y	12/08/2006	12/08/2006	0		PVT	PVT	Zoladex, Atenolol, Letrozole, Calcuim		Penicillin, hypertension, status post Right mastectomy 5/06			1						1	Injection site swelling; Myalgia; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA208BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0985F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268952	12/15/2006	CA	53.0	53		F	11/13/2006	Employee felt like she needed more air, needed to open window in office approx 30 minutes after receiving shots. Symptoms resolved within a few minutes after intervention and did not return. Developed fine light pink rash 11/2/06 on arms and legs. Rash resolved 11/9/06.									Y	11/06/2006	11/06/2006	0	NONE	PUB	OTH	Ibuprofen, MVI		Silocaine-shortness of breath			1						1	Dyspnoea; Rash	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0268953	12/15/2006	CA	1.03	1	.0	M	12/08/2006	Lump on left thigh red (marble size) grade, high grade fever 2nd day post vaccine.				Y					U	11/27/2006	12/01/2006	4	NONE	PVT	PUB	NONE	NONE	Lactose intolerant			1						1	Erythema; Injection site mass; Pyrexia	FLU3~SANOFI PASTEUR~2191JA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0198F~UNK~~LL~HIB + HEP B (COMVAX)~1|MMRV~MERCK & CO. INC.~1092F~1~~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0268954	12/15/2006	TX	49.0	48		F	12/14/2006	2 hours after shot felt flushed, dizzy. Vomited by 3.5 hours later. Had ENT, neuro evaluation. Diagnosed as labyrinthritis associated with vaccine. Still with dizziness 6 weeks later. Administered 10/17/06. Per report from doctor: Patient received flu vaccine on 10/27/06 and suffered a vertigo type reaction within a few hours after the vaccine was administered. Dr. discussed with patient. Patient states she has taken the flu vaccine for many years with difficulty. She received shot at about 8am and by 10am felt flushed and dizzy. This worsened and by 11:30 am she was vomiting. She has been evaluated by her internist as well as ENT and neurologist. They feel the reaction is probably associated with the vaccine and have diagnoses labyrinthitis. She is improving but still has some dizziness. She has been treated with antibiotics and steroids.				Y					N	10/27/2006	10/27/2006	0	MRI, lab normal per patient. Unknown details.	OTH	PVT	Benacar 40/25, Toprol 25	NONE	hypertension			1						1	Dizziness; Flushing; Labyrinthitis; Vertigo; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA210AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0268960	12/15/2006	IL	89.0	89		F	12/14/2006	Soreness and stiffness at and around injection site lasting greater than 30 days. Has received anti inflammatory treatment.				Y					U	11/07/2006	11/08/2006	1		OTH	PVT		NONE				1						1	Musculoskeletal stiffness; Myalgia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71832~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0268962	12/15/2006	CA	33.0	32		F	12/15/2006	3 days had the hot, pink, itching localized symptoms at site of injection. Fluzone administered on Dec 13 2006. Client waited till Dec 15 2006 to report condition.									U	12/13/2006	12/13/2006	0		OTH	OTH	NONE	NONE				1						1	Feeling hot; Injection site erythema; Pruritus	FLU3~SANOFI PASTEUR~2284AA~2~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268963	12/15/2006	CA	1.03	1	.0	F	12/15/2006	A day after receiving above vaccine on 11/14/06 mom states child was weak and weird with a dazedlook to the eyed for about 2 days. On Monday child was acting different since she got the shots.									Y	11/14/2006	11/14/2006	0	NONE	PVT	PUB	Amoxcillin and Dimetapp	upper respiratory illness and otitis media	club feet			1						1	Muscular weakness; Staring; Vaccination complication	FLU3~SANOFI PASTEUR~U2251AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0510F~1~~RL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~0977F~1~~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0268966	12/15/2006	TN	46.0	46		M	12/14/2006	Patient received Flumist on 10/6/06. Approx 15-30 min after administration he began to experience a headache that progressively became worse by later that afternoon. Patient experienced headache for 1 1/2 weeks. Headache was described as dull but disturbing. Patient had to take extra strength Tylenol four times a day for 1 and 1/2 weeks to relieve pain.									Y	10/06/2006	10/06/2006	0		PUB	OTH	Lovesten, allergy injections					1						1	Headache	FLUN3~MEDIMMUNE VACCINES, INC.~500435P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0268977	12/15/2006		55.0			M		Patient developed diffuse urticarical rash on arms. Was given a start dose of flu vaccine prior to developing rash. Was given a prednisone taper to minimize rash.										11/10/2006				UNK	UNK	Advair, Aspirin, Atenlol, Baclofen, Plavis, Prilosec		Coronary atherosclerosis, asthma hypertension			1						1	Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F602611~UNK~IM~~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0268984	12/15/2006	MI	57.0	57		M	12/15/2006	Pm of the day receiving the pneumonia vaccine. Left upper arm swollen, hard and very warm to touch. Had limited movement. This lasted into the next day. Today, 12/15/2006, have a red flat rash area on the muscle of the upper left arm. The pain is lessening, but remains tender.										12/13/2006	12/13/2006	0		MIL	OTH	Coumadin           Lisinopril Paxil               Aleve Lipitor Lorazepam Hydrocodone 7.5 w/Tylenol 750		Aortic Valve replacement, PTSD, Aseptic Necrosis-Left Hip, Arthritis in neck, shoulders, hips, knees and toes			1						1	Erythema; Feeling hot; Pain; Rash; Swelling	FLUX~UNKNOWN MANUFACTURER~0000000000000~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0268985	12/15/2006	CO	11.0	11		M	12/15/2006	Patient felt dizzy and blacked-out five minutes after receiving the influenza vaccine.  His mother was standing beside him and was able to catch him and prevent him from falling.  His extremities were diaphoretic. Blood pressures were 108/80 (left arm, seating) and 110/78 (left arm, supine).  Emergency service arrived but patient recovered and did not require hospitalization.  Patient was advised to take Benadryl 12.5mg every 4 to 6 hours if he developed a rash.									Y	12/11/2006	12/11/2006	0	None	UNK	UNK	none	none	Penicillin allergy Asthma			1						1	Dizziness; Hyperhidrosis; Syncope	FLU3~SANOFI PASTEUR~U2218AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268989	12/15/2006	CA	52.0	52		F	12/15/2006	High fever 130.2for 24 hours. Went down to 102. Third day very bad diarria.									Y	12/12/2006	12/12/2006	0		UNK	UNK		none	none			1						1	Diarrhoea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0268993	12/15/2006	IL	65.0	65		M	12/15/2006	Aproximately 1 week after injection, patients states he developed severe joint pain in back hips feet elbows.  No fever.  Sought medical attention from primary doctor.				Y					N	10/20/2006	10/27/2006	7	Patient states no labs done	UNK	UNK	Inhaler on occassion	None	Emphazema			1						1	Arthralgia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70739~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0268996	12/16/2006	PA	5.0	5		F	12/16/2006	rash on face, hives all over body, was given 4 shots, 2 in each arm, unsure of which arm except tetnus									U	12/15/2006	12/16/2006	1	none	UNK	UNK	none	none	none			1						1	Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~UN~HEP A (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~LA~TETANUS TOXOID (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~UNK~~UN~VARICELLA (NO BRAND NAME)~1	USA		Influenza
0268997	12/17/2006	CA	8.0	8		M	12/17/2006	Pox on leg and face, Fever (101 deg F), tired. Pox remained for 5 days. Treatment childrens Motrin.									Y	12/11/2006	12/12/2006	1	None	UNK	UNK	None	Flu Symptoms (Fever, nasal drip, tired)	None			1						1	Fatigue; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~2~~~VARICELLA (NO BRAND NAME)~1	USA		Influenza
0268998	12/17/2006	TX	58.0	58		F	12/17/2006	Patient developed painful, itchy rash with blisters.  Rash was in patches over most of her body. Rash developed approximately 24 hours after receiving flu vaccine.  She received the vaccine on 12/13/06.  She went to the doctor Saturday, 12/15 & was kept over night in the hospital.  She was much better Sunday morning, 12/16 & was discharged with prescription for Medrol Dosepak, Benadryl, & Vicodin.  Her husband says the doctor said reaction was probably from the flu shot. She said she had received flu shots in the past.  1/18/07 Received medical records from hospital which reveal patient admitted 12/16-12/17/06 following rapid progression of extensive rash 48-72 hours after flu fax.  Rash was exceedingly painful & pruitic. Also had fever, chills & malaise & night prior to admit had nausea & vomiting. Treated w/IV steroids & Benadryl.  Rash almost completely resolved within 24 hours.  D/C home on steroids, pain med & Benadryl.  Allergy referral was recommended. FINAL DX: Erythema multiforme, presumed secondary to flu vax; & asthma.				Y	Y	1			U	12/13/2006	12/14/2006	1	unknown LABS: WBC 4.9	UNK	UNK	none	no	unknown PMH: asthma, DJD, GERD			1						1	Blister; Pain; Rash pruritic	FLU3~SANOFI PASTEUR~U2258AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0269000	12/17/2006	NC	3.0	3		M	12/17/2006	fever on day two, and severe rashm with small bumps, it does not look like hives, because the bumps are very small, almost like hundreds of bug bites, severe itching, very uncomfortable, benadryl and over the counter hydrocordisone given per doc. suggestion, helped with itching, but sill has the rash.									U	12/14/2006	12/15/2006	1		UNK	UNK	singular albuterol (as needed)	cold, and slight weezing/tightness in the chest, and recovering from a cold	cronic ear infections from 10 months-15 month, tubes put in the ears at 15 month, no ear infections since then, tubes both still in.			1						1	Discomfort; Pruritus; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~3~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~1~IM~RL~HEP A (NO BRAND NAME)~1	USA		Influenza
0268543	12/18/2006	CO	4.0	4		F	12/14/2006	Initial report received on 06 December 2006 from a consumer and additional information provided via contact with health care professionals. A four year old female patient had received a first dose, intramuscular, left thigh injection for Fluzone,lot number U2281AA, and a first dose, intramuscular, right thigh injection of Hepatitis B vaccine, lot number 0614R, on 28 November 2006. Fluzone had been administered from a multidose viral from which no other patient developed any problems. Illness at the time of vaccination included a mild upper body rash that started approximately seven days prior to immunization. At the time of immunization, the patient had two rash spots remaining on her right underarm. Five days post immunization, the patient experienced left thigh pain, limp, and fever (temperature not specified). there was no cellulitis. WBC was 19,000 and CRP was 77.7, ESR was 24. Follow up laboratory results the next day revealed ESR was 82. MRI showed myositis. The patient was diagnosed with myositis of the left rectus femoris (initially reported as a bone infection) and was admitted to the hospital. Blood culture, urine culture, and strep culture of the throat were negative. The patient was treated with intravenous Cefazolin. Infectious disease consultant noted that there was no basis for suspecting contaminated vaccine, find no such note in the chart, and no house staff admit to saying that. The event required hospitalization for two days, and the patient subsequently recovered from the event.				Y	Y	2			Y	11/28/2006	12/03/2006	5		PVT	PVT			The patient had a mild upper body rash at the time of vaccination. There was no other past medical history and no other medications.		200603396	1						2	Hypotonia; Injection site pain; Laboratory test abnormal; Myositis; Pyrexia; Red blood cell sedimentation rate increased; White blood cell count increased; Gait disturbance; Injection site pain; Laboratory test abnormal; Myositis; Pyrexia; Red blood cell sedimentation rate increased; White blood cell count increased	FLU3~SANOFI PASTEUR~U2281AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0614R~1~IM~RL~HEP B (RECOMBIVAX HB)~1|FLU3~SANOFI PASTEUR~U2281AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|HEP~MERCK & CO. INC.~0614R~1~IM~RL~HEP B (RECOMBIVAX HB)~2	USA	Hospitalisation	Influenza
0268964	12/18/2006	IL	47.0	47		M	12/15/2006	Receive flu shot 10/17/06. 10/28 and 10/29 soreness at injection site Right deltoid. 10/30 noted burning sensation Left arm, left shoulder, left forearm onto L chest-continued thru today. Some days intermittent some days worse then others. To Employee Health-Emergency department to rule out cardiac, PCP				Y					N	10/27/2006	10/30/2006	3		PVT	OTH		NONE	NONE			1						1	Myalgia; Skin burning sensation	FLU3~SANOFI PASTEUR~U2274AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269014	12/18/2006	WI	56.0	56		F	12/13/2006	Information has been received from a physician concerning a 56 year old female who on 18 Oct 2006 at 4:15 pm was vaccinated with a second dose of Pneumococcal 23v polysaccharide vaccine (lot 651400/0618F) (0.5ml), intramuscularly in the right deltoid. Concomitant therapy that day and time included a dose of influenza virus vaccine (lot 69898), intramuscularly in the left deltoid. There was no illness at the time of vaccination. Subsequently, a few hours after receiving the injection the patient was complaining of pain. The patient was unable to move her right arm where the injection was given. It was also reported that on 19 Oct 2006 at 8:00 am the patient's right arm extremely sore unable to move, decreased range of motion. Subsequently, the patient recovered. It was noted that the patient had no adverse events following prior vaccination. The reporter considered the patients experience to be disabling. Additional information has been requested.				Y				Y	Y	10/18/2006	10/18/2006	0		PVT	PVT					WAES0610USA13035	1						1	Joint range of motion decreased; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69898~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0618F~2~IM~~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0269016	12/18/2006	PA	67.0	67		M	12/14/2006	A 67 year old male patient, with no illness at the time of vaccination, had received a first dose of Fluzone, lot number U2273AA, on 05 October 2006. The following day, the patient developed a full body rash described as pruritic and erythematous. he was treated with Atarax and DepoMedrol. On 11 October 2006, the patient was referred to a dermatologist and was treated with steroids and antibiotics. He was subsequently hospitalized on 13 October 2006 and discharged on 17 October 2006. results of a skin biopsy were pending. The patient recovered from the event.					Y	5			Y	10/05/2006	10/06/2006	1		PVT	UNK			The patient had a history of hypertension and allergies to Biaxin and Avalox.		200603401	1						1	Purpura; Rash erythematous	FLU3~SANOFI PASTEUR~U2273AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0269017	12/18/2006	FL	1.6	1	.6	M	12/14/2006	Seriousness criteria other medically significant (OMIC). initial report received on 07 December 2006 from a health care professional. A 19 month old male patient had received a first dose, left thigh injection of Fluzone, lot number 2191AA, on 01 December 2006. Approximately ten hours later, the patient experienced a fever of 102.6 degrees F, seizure, body shaking, eyes rolled back which lasted for two minutes. He was examined in an emergency room and treated with Rocephin. Additional symptoms included runny nose. Blood cultures obtained in the emergency room were pending. He was re examined the following day by his personal physician to determine if the seizure was due to fever. Information related to this exam was not provided. The patient recovered from the event.				Y					Y	12/01/2006	12/01/2006	0		PVT	UNK	Prevacid		The patient had a history of GI reflux for which he took Prevacid. There was no illness at the time of vaccination.		200603409	1						1	Convulsion; Eye movement disorder; Pyrexia; Rhinorrhoea; Tremor	FLU3~SANOFI PASTEUR~U2191AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269018	12/18/2006	MI	46.0	46		F	12/14/2006	Seriousness criteria other medically significant (OMIC). Initial report received on 08 December 2006 from a health care professional. A 46 year old female patient had received an intramuscular injection of Fluzone, lot number U2215AA, on a date between 14 November 2006 and 18 November 2006. There was no illness at the time of vaccination. the reporter was unsure of past medical history, but the patient dose take Singulair and Effexor. on 18 November 2006, the patient was diagnosed with Bell's Palsy. The event required examination by a physician. She was treated with prednisone and Lacrilube. relevant diagnostic testing included CBC, sedimentation rate, and Lyme test. Results were not provided. Recovery status was not reported.				Y					U	11/14/2006	11/18/2006	4		UNK	UNK	Singulair, Effexor				200603443	1						1	Facial palsy	FLU3~SANOFI PASTEUR~U2215AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269019	12/18/2006	VT				U	12/14/2006	Seriousness criteria other medically significant (OMIC). Initial information received on 11 December 2006 from another manufacturer (no reference number provided). The information was originally provided to the other manufacturer by a health care professional. A patient (gender and birth date not reported) received a dose of influenza vaccine 20 years ago. The trade number, manufacturer and lot number were not reported. An unspecified amount of time later, the patient experienced an anaphylactic reaction. Per the reporter, no other information was available at the time of this report. It was not reported whether the patient recovered from the event.				Y					U					UNK	UNK					200603455	1						1	Anaphylactic reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0269021	12/18/2006	MO	3.0	3		M	12/13/2006	Seriousness criteria other medically significant (OMIC). Initial report received on 05 December 2006 from a health care professional. A three year old male patient, with no pre existing medical history, had received an intramuscular, left thigh injection of Fluzone, lot number U2239AA, on 03 November 2006. He had previously received four doses of influenza vaccine with no reported adverse effect. Other medications included Claritin as needed. Two weeks post vaccination, the patient developed bruising. Seventeen days later, laboratory testing showed a decreased platelet count of 19,000. The patient was diagnosed with idiopathic thrombocytopenic purpura. At the time of this report, the patient had not recovered. Additional medically relevant information was not provided.				Y					N	11/03/2006	11/17/2006	14		UNK	UNK	Claritin				200603394	1						1	Contusion; Platelet count decreased; Thrombocytopenic purpura	FLU3~SANOFI PASTEUR~U2239AA~5~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269031	12/18/2006	KY	4.0	3		M	12/18/2006	Right thigh firm, tender with erythema				Y					N	12/15/2006	12/16/2006	1		PVT	UNK		Upper respiratory infection	NONE			1						1	Erythema; Tenderness	FLU3~SANOFI PASTEUR~U2282AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269033	12/18/2006	MD	5.0	5		M	12/07/2006	Childe has history of asthma and inadvertently received FluMist vaccine on 10/26/06 during a school based immunization. No immediate adverse effects. Child did develop Upper Respiratory symptoms about 11/11/2006. Did not require physician visit or school absence. Treated with Albuterol inhaler.									Y	10/26/2006	11/11/2006	16	NONE	OTH	PUB	Albuterol inhaler prn asthma attacks	NONE	Asthma			1						1	Upper respiratory tract infection	FLUN3~MEDIMMUNE VACCINES, INC.~500439P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0269039	12/18/2006	VT	82.0	82		M	12/13/2006	Chills, sweats, erythema at shot site and lymphedema of entire Right upper arm.									Y	11/14/2006	11/14/2006	0	Patient has history cardiac cath Right anti-colital approach in distant past.	PVT	PVT	Aspirin, Actonel, Lipotor,Noscor, retoprolol	NONE	No allergies, history of arteriosclerotic heart disease, prostate cancer			1						1	Chills; Erythema; Hyperhidrosis; Lymphoedema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72008~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0485F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0269040	12/18/2006	VT	60.0	60		M	12/16/2006	Severe swelling, redness, pain at injection site accompanied by shaking rigors. (I did not see the patient, he described these symptoms to me on 12/8/06).									Y	11/22/2006	11/23/2006	1	NONE	PVT	PVT	Lexapro, Lipitor, San Palmetto.	NONE	Macular degeneration			1						1	Erythema; Pain; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA240AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0485F~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0269041	12/18/2006	OK	58.0	57		F	12/13/2006	Received 1.0ml of flu vaccine. Increased pain and discomfort at injection site more than she usually experiences. She states gets the flu shot every year. Complained of mottling at site. Sore arm for 4 days.									Y	11/27/2006	11/27/2006	0	NONE	PVT	PVT	Serevent, Diskkus, Glucosamine, Prednisone	Asthma attack flareup	Allergies: eggs, penicillin, Darvon, Tetanus, Numorphine. Asthma			1						1	Discomfort; Livedo reticularis; Pain	FLU3~SANOFI PASTEUR~U2202AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269042	12/18/2006	OK	65.0	65		F	12/13/2006	Received 1.0 flu vaccine IM mild soreness and injection site.									Y	11/28/2006	11/28/2006	0	NONE	PVT	PVT	Toprol 100mg daily, Captopril 25mg, TID, Norvasc 10mg daily, Furosemide 20mg daily, Vytorin one daily, Gluchphage 2 pills BID, Lantus Insulin at bedtime 18u units, Aspirin 325 mg, Potassium TID	NONE	(Allergy- Codeine), CHF, Diabetes, Hypertension			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U2272AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269043	12/18/2006	OK	46.0	46		M	12/13/2006	Dose 1.0 ml Fluzone administered IM, denies any adverse reaction.									Y	11/27/2006	11/27/2006	0	NONE	PVT	PVT	PROTONIX	NONE	GERD, ARTHRITIS, (PENICILLIN, CODEINE ALLERGY)			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2272AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269044	12/18/2006	OK	24.0	24		F	12/13/2006	Received 1.0 ml Flu vaccine. Soreness arm for 2 days took Ibuprofen.									Y	11/27/2006	11/27/2006	0	NONE	PVT	PVT	NONE	NONE	ALLERGY- AMOXICILLIN			1						1	Pain	FLU3~SANOFI PASTEUR~U2272AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269045	12/18/2006	OK	39.0	39		F	12/13/2006	Received 1.0 ml of Flu vaccine. Complain of rather severe pain in arm for 3 days, much more severe than usual took Ibuprofen. Bruise large injection site. Arm ached- resolve after 3 days.									Y	11/27/2006	11/27/2006	0	NONE	PVT	PVT	YASMIN, DIOVAN. HCTZ, IBUPROFEN	NONE	Allergy- Penicillin, Hypertension			1						1	Contusion; Pain	FLU3~SANOFI PASTEUR~U2272AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269046	12/18/2006	OK	26.0	26		F	12/13/2006	Received 1.0 ml Flu vaccine IM, injection site sore for 2 days.									Y	11/27/2006	11/27/2006	0	NONE	PVT	PVT	NONE	NONE	Polycystic Ovarian Syndrome			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U2202AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269047	12/18/2006	OK	46.0	46		F	12/13/2006	1.0 ml administered IM, low grade temperature less than 24 hours. She did not measure her temperature, mild muscle soreness at site of injection.									Y	11/27/2006	11/27/2006	0	NONE	PVT	PVT	IBUPROFEN, LASIX, TRAMADOL, POTASSIUM, ATENOLOL, ZOCOR, PAMELOR	NONE	Fibromyalgia, deep vein thrombosis history, Penicillin			1						1	Body temperature decreased; Injection site pain	FLU3~SANOFI PASTEUR~U2272AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269048	12/18/2006	OK	52.0	52		F	12/13/2006	Received 1.0 ml Flu vaccine IM. Complain of throat felt scratchy for 24 hours. Sore arm- more than usual 2-3 days. Headache for 2 days (went to bed used Tylenol).									Y	11/28/2006	11/28/2006	0	NONE	PVT	PVT	SYNTHYROID, ALLOPURINOL, PREMARIN	NONE	hypothyroidism, gouty arthritis			1						1	Headache; Pain	FLU3~SANOFI PASTEUR~U2202AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269049	12/18/2006	OK	60.0	60		F	12/13/2006	Received 1.0 ml Flu vaccine IM. Arm - more sore- lasted 4-5 days, low grade temperature for 1 day (took Tylenol) better on 5th day (felt better).									Y	11/27/2006	11/27/2006	0	NONE	PVT	PVT	OGEB	recent cold	NONE			1						1	Body temperature decreased; Pain	FLU3~SANOFI PASTEUR~U2272AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269050	12/18/2006	OK		57		F	12/13/2006	Received 1.0 ml flu vaccine IM. Complain of soreness at injection site for 2 days and took Ibuprofen.									Y	11/27/2006	11/27/2006	0	NONE	PVT	PVT	TOPROL, SYNTHYROID, POTASSIUM, INDAPAMIDE	NONE	MVP, Hypertension, Hypothyroidism			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U2202AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269051	12/18/2006	OK	50.0	50		F	12/13/2006	Received 1.0 ml Flu vaccine IM. Usual soreness at injection site for 2-3 days. No complain of unusual adverse symptoms.									Y	11/27/2006	11/27/2006	0	NONE	PVT	PVT	PREMPRO, HCTZ, CELEBREX, COZAAR	NONE	allergy: Penicillin, Arthritis, HTN, Defect repair atrial septral age 21			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U2202AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269052	12/18/2006	AK	1.45	1	.4	M	12/07/2006	PA-C who was seen child today stating child has maculopapular rash interior, posterior trunk extended to neck and upper extremities. No fever. Petechiae in oropharynx.				Y					Y	11/20/2006	12/03/2006	13		PUB	PUB		NONE			AK200665	1						1	Petechiae; Rash maculo-papular	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B032AA~5~~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2175GA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0889R~4~~RL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0424R~2~~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA	Emergency room visit	Influenza
0269053	12/18/2006	AK	46.0	46		F	10/23/2006	Immediate swelling and discoloring at the injection site. Swelling continued for about 40 minutes. Entire upper arm from shoulder to elbow swollen. Face and neck flushed bright red. Tingling sensation of arm and fingers. Patient felt light-headed. All symptoms resolved within 90 minutes.									Y	10/20/2006	10/20/2006	0	NONE	OTH	PUB	NONE	NONE	NONE			1						1	Dizziness; Flushing; Injection site swelling; Paraesthesia; Skin discolouration	FLU3~SANOFI PASTEUR~U2237AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269056	12/18/2006	CA	2.0	2	.8	F	12/12/2006	None. Pt had usual side effects after immunization. I called checked with parent for follow up appointment did fine.									Y	10/26/2006			NONE	PVT	PVT		NONE	NONE			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2164AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269057	12/18/2006	CA	3.0	3		F	12/12/2006	None. Pt should have received .5 ml of Flu vaccine but was given .25 ml by mistake. (Pt turned 3 years old on 12/3/06)									Y	12/11/2006	12/11/2006	0	NONE	PVT	PVT		NONE	NONE			1						1	Medication error	FLU3~SANOFI PASTEUR~UT2175CA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269058	12/18/2006	CA	7.0	7		M	12/12/2006	Pityriasis rosea, presumed										11/29/2006	12/05/2006	6	NONE	PVT	UNK						1						1	Pityriasis rosea	FLUN3~MEDIMMUNE VACCINES, INC.~500437P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0269059	12/18/2006	PA	4.0	4		M	12/13/2006	Arm red, indurated									Y	12/06/2006	12/07/2006	1		PVT	PVT						1						1	Erythema; Injection site induration	DTAP~SANOFI PASTEUR~C2989AA~5~~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2187AA~3~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~1027F~4~~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~20001~2~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0269060	12/18/2006	AR	66.0	66		F	12/13/2006	Paralyzed waist down for 3 days Collapsed lung currently 12/27/06-records received and reviewed from Dr. DX: serum sickness. Multiple joint deformity swelling and tenderness				Y					U	11/05/2006			Unknown	OTH	PUB	Plavix, aspirin	not sick today day of vaccine	Unknown			1						1	Collapse of lung; Joint swelling; Paralysis; Serum sickness; Tenderness	FLU3~SANOFI PASTEUR~U2216AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269061	12/18/2006		9.0	8		F	12/07/2006	Patient awoke the day after vaccination with reddened, swollen, tender, warm injection site. At 42 hours post injection site red, swollen, warm to touch and 6.5x4.5cm in size of reddened area. Treatment: Baby Motrin and if needed Augmentin solution to start tomorrow.									Y	12/05/2006	12/06/2006	1		OTH	OTH		NONE				1						1	Erythema; Swelling; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~068801~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0269062	12/18/2006	VA	1.27	1	.3	F	12/07/2006	Urticarial rash (vaccine reaction?)									Y	12/06/2006	12/07/2006	1	Benadryl 1/2 tsp every 6 hours	PVT	UNK		NONE	NONE			1						1	Urticaria	DTAPH~SANOFI PASTEUR~UI965AA/UE959AA~1~IM~RL~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~U2260AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B086910~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0269063	12/18/2006	NJ	47.0	46		F	12/13/2006	11/21 and 11/22-headache, stiff neck, low grade fever; 11/23 felt fatigued, neck and back pain; 11/24 night sweats-joints ached, felt warm and knees became swollen. Temp 101.5; 11/26 difficulty walking-went to emergency room. Treated with IV fluid and anti- flammatory med. Discharged with Doxyclyine and Naprocyn; 11/28 went to primary care physician-had urinary tract infection, given Cipro and cortisone shot; 12/1 inflammation decreased and saw a rheumatologist. Blood work drawn.				Y					Y	11/20/2006	11/21/2006	1		OTH	OTH	NONE	Denied	Denied			1						1	Difficulty in walking; Fatigue; Headache; Inflammation; Joint stiffness; Swelling; Urinary tract infection	FLU3~SANOFI PASTEUR~42166JA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269064	12/18/2006	AR	9.0	9		F		Large (6 cm) area red and swollen at injection site.									U	12/05/2006	12/06/2006	1	NONE	PVT	PUB		NONE	NONE			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~02245AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269065	12/18/2006	FL	12.0			F	11/17/2006	11/16 p.m. rash noted around injection site - rash pruritic									Y	11/15/2006	11/16/2006	1		PVT	PVT	NONE	NONE	NONE			1						1	Injection site reaction; Rash pruritic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71829~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC5280038A~1~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0269066	12/18/2006	NY	83.0	83		F	12/11/2006	Patient had flu shot on 11/28/2006. On 12/02/2006 developed intermittent tremor on left arm that became constant 12/03/2006 (same arm as vaccinated).				Y					U	11/28/2006	12/02/2006	4		PVT	PVT	enolapan, warfarin, lipitor, novasc, lexapro,	NONE	NONE			1						1	Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601211~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0269067	12/18/2006	NY	4.0	4		F	12/12/2006	Left upper arm turned red, hot to the touch, then the whole body was covered in a non-itchy rash. Child's arm hurt very badly. Took her to hospital and to her doctor, who diagnosed her with cellulitis from the flu shot.				Y					N	12/06/2006	12/07/2006	1		PVT	OTH		NONE	Scarlet fever diagnosed 1 week prior to shot			1						1	Cellulitis; Feeling hot; Injection site erythema; Injection site pain; Rash	FLUX~UNKNOWN MANUFACTURER~90658~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0269068	12/18/2006	NJ	1.25	1	.3	M	12/11/2006	Temp 100F- possible seizure/ choking while sitting in car seat foaming at mouth-mouth clenched shut.  12/20/06 Received medical records from PCP which included ER records which reveal patient seen in ER for febrile seizure following a week long hx of cough & congestion.  Temp 102.7 in ER.  PCP record on 11/28 day of vax reveals patient was well. Final DX: benign febrile seizure & URI per ER physician.  PCP note stated probable MMR febrile reaction.				Y					Y	11/28/2006	12/07/2006	9		PVT	PVT		NONE	Cough & congestion for approx 1 week prior to ER visit			1						1	Choking; Convulsion; Pyrexia	FLU3~SANOFI PASTEUR~U2191AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE917AA~4~IM~LL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~1025F~1~SC~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|PNC~PFIZER\WYETH~B08683C~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0269069	12/18/2006	PA	1.33	1	.3	F	12/11/2006	Fever-seizure				Y					Y	11/29/2006	12/07/2006	8		PVT	PVT	NONE	NONE	NONE			1						1	Convulsion; Pyrexia	FLU3~SANOFI PASTEUR~U2191AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE917AA~4~IM~LL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~1025F~1~SC~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|PNC~PFIZER\WYETH~B08683E~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0269070	12/18/2006	NC	9.0	9		F	12/18/2006	Patient developed hives / urticaria on 14-DEC-2006.				Y					U	12/08/2006	12/14/2006	6	NONE	PVT	UNK		Hives	Allergic rhinitis, mild int asthma			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2215AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0439F~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0269071	12/18/2006	TX	1.26	1	.3	M	12/15/2006	Fever 102 degrees F, crying, difficulty walking									Y	12/14/2006	12/14/2006	0	NONE	PUB	PUB		NONE	NONE			1						1	Crying; Difficulty in walking; Pyrexia	FLU3~SANOFI PASTEUR~42191CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF023AA~4~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B086725H~4~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0269145	12/18/2006	IL	77.0	77		F	12/14/2006	Information has been received from a 77 year old female with allergies to cefaclor (CECLOR) and relafan, and a history of shoulder replacement in 1997, who on 10-Nov-2006 was vaccinated in her arm with a first dose of varicella-zoster virus vaccine live. Concomitant vaccination included a dose of influenza virus vaccine (unspecified) (manufacturer unknown) and a dose of pneumococcal 23v polysaccharide (manufacturer unknown). Concomitant therapy included metoprolol succiante (TOPROL XL TABLETS), simvastatin, escitalopram oxalate (LEXAPRO), aspirin, esomeprazole magnesium (NEXIUM) and minerals (unspecified) (+) vitamins (unspecified) (CENTRUM). On 15-Nov-2006 the patient developed little red itchy bumps all over her body. The patient thinks it's chicken pox. It was reported that the bumps kept building up and gradually got worse starting on 18-Nov-2006. She reported that some of th bumps were turning into scabs. She was putting triancinoioneacetonide ointment on them. Medical attention was not sought though the patient stated that she was going to call her physician and make an appointment. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information was available. Additional information has been requested. 6/17/10 Additional informatin from the nurse practioner indicated that on 20-NOV-2006 she examined the patient in the office and the patient had about 6 lesions, 4 mm in size. No other information was available.									N	11/10/2006	11/15/2006	5	NONE	OTH	OTH	aspirin, LEXAPRO. NEXIUM, TOPROL XL TABLETS, CENTRUM, ZOCOR	CONCURRENT CONDITIONS: Allergic reaction to antibiotics, Drug hypersensitivity	MEDICAL HISTORY: Shoulder replacement		WAES0611USA05895	1						1	Rash erythematous; Rash pruritic; Scab; Skin lesion	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~UN~PNEUMO (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~1~~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0269153	12/18/2006	CO	61.0	61		F	12/14/2006	Information has been received from a health professional concerning a 61 year old white female with hypertension, hyperlipids, allergies to bee stings and penicillin who on 09 Nov 2006 at 10:00 was vaccinated in the left deltoid with a first dose of Zostavax (lot # 652965/0622F). Concomitant therapy included influenza virus vaccine (unspecified). There was no illness at the time of vaccination. On 10 Nov 2006 at 12:00 am, the patient developed a lump in her muscle the size of a tennis ball which was red, raised and hot to touch. The patient had shortness of breath and rapid pulse rate. The patient is allergic to bee stings and she described her reaction as such. Unspecified medical attention was sought. No epinephrine was given. One week post vaccination, the lum was gone and some redness and itching were noted. The patient recovered on 18 Nov 2006. Additional information has been requested.				Y					Y	11/09/2006	11/10/2006	1	UNK	PVT	PVT			hypertension, hyperlipidaemia, allergic reaction to bee sting, pencillin allergy		WAES0611USA06761	1						1	Dyspnoea; Erythema; Heart rate increased; Injection site mass; Pruritus; Skin warm	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~0622F~1~~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0269159	12/18/2006					F	12/14/2006	Information has been received from a physician concerning his wife who on 27 Nov 2006 was vaccinated with a dose of Zostavax. Concomitant vaccination on the same day included a dose of influenza virus vaccine (unspecified) and a dose of Pneumovax (MSD). On 29 Nov 2006, 48 hours later, the patient developed a low grade fever (100.5) and pain at the Zostavax injection site with the appearance of local vesicles at injection site which have persisted for 24 hours. She was taking nonsteroidal anti-inflammatory drugs for the pain and fever without complete relief. As of 04 Dec 2006, she was doing better. The vesicular lesions were healing and the injection site pain in both arms was less severe. No further information is available.									N	11/27/2006	11/29/2006	2	Body temp 11/19/06 100.5	OTH	OTH			UNK		WAES0611USA00011	1						1	Injection site vesicles; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~~UNK~~~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0269222	12/18/2006	PA	21.0	21		F	04/06/2007	Information has been received from a nurse concerning a female who was vaccinated with a first dose of HPV vaccine. It was reported that immediately upon administration of the vaccine, the patient developed excessive swelling near the injection site. Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown.  This is in follow-up to report(s) previously submitted on 12/14/2006.  Initial and follow-up information has been received from a nurse and a physician concerning a 21 year old white female student with asthma who on 24-NOV-2006, at 12:00 p.m., was vaccinated IM, into the right arm, with a first dose of GARDASIL (lot #654389/0961F) concomitantly with a sixth dose of FLUZONE (lot #U2197AA) IM, into the left arm.  On 24-NOV-2006, at 12:01 p.m., the patient developed immediate swelling at the injection site.  The patient recovered on the same day.  There were no laboratory or diagnostic tests performed.  Additional information is not expected.				Y					Y	11/24/2006	11/24/2006	0	None	PVT	OTH	UNK	Asthma	UNK		WAES0611USA07057	1						1	Immediate post-injection reaction; Injection site oedema; Injection site swelling	FLU3~AVENTIS PASTEUR~U2197AA~6~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0961F~1~IM~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0269224	12/18/2006		18.0	18		F	12/14/2006	Information has been received from a nurse practitioner concerning an 18 year old female with a history of drug reaction/allergy to VICODIN who on 27 Nov 2006 was vaccinated with first dose of HPV vaccine injection into left arm. Concomitant therapy included influenza virus vaccine (unspecified) injection also administered the same day on 27 Nov 2006 into her left arm, YASMIN, Minocycline. On 28 Nov 2006, the patient experienced tingling, swelling, and redness in her left arm and hand. She also experienced swelling and redness in her right hand thumb, and some soreness in her chest and upper body area. The patient sought medical attention. No diagnostic tests were performed. Additional information was obtained from the nurse practitioner via phone call. The patient was vaccinated with HPV vaccine and a flu vaccine on 27 Nov 2006 in her left arm by her primary care physician. The patient was seen in her clinic less than 24 hours later experiencing swelling and numbness of fingers, and chest wall discomfort. The patient was seen for follow upon 29 Nov 2006 and all symptoms had resolved. Additional information has been requested.				Y					Y	11/27/2006	11/28/2006	1	UNK	OTH	OTH	YASMIN, Minocycline		UNK		WAES0611USA07269	1						1	Chest discomfort; Chest pain; Erythema; Hypoaesthesia; Injection site erythema; Injection site oedema; Oedema; Pain; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~1~~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0269267	12/18/2006	KY	42.0	41		F		Vaccine was administered to the left upper arm. Having limited mobility, soreness, pain, difficulty lifting-pulling. Weakness, dizziness. Left side warmness. Upset stomach.										11/15/2006	11/16/2006	1		PUB	UNK		NONE				1						1	Abdominal pain upper; Feeling hot; Joint range of motion decreased; Myalgia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0269310	12/18/2006	VA	32.0	32		F	12/18/2006	9 days after influenza vaccine reported painful right arm that began few hours after influenza injection and is constant pain with weakness of right arm unrelieved by alternating tylenol and motrin 800mg. Mid right deltoid warm to touch, red and swollen referred to ER for further evaluation and treatment. Prescribed Toradol and Darvon for pain which relieved symptoms after few days of treatment. 8 weeks after influenza vaccine she called to report that her symptoms had reappeared and that she could not work and take the Darvon and Tordal due to drowsiness and she was referred to Human Resources dept. to pick panel physician and have further evaluation.				Y					U	10/18/2006	10/18/2006	0	None done intially and follow is unknown at this time	UNK	UNK	None	no	Past Medical History of asthma. Denied any pre-existing phyician-diagnosed allergies or other medical problems			1						1	Asthenia; Erythema; Feeling hot; Pain; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA 2018A~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0269312	12/18/2006	VA	3.0	3		M	12/18/2006	Pt given Fluvirin vaccine used only for children 4 years and above, instead of Fluzone.  Per his mother there were no adverse reactions.  Pt has required no additional tests or treatment.									Y	11/29/2006			none	UNK	UNK		none	none			1						1	Medication error	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70385~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0269313	12/18/2006	MO	4.0	4		M	12/18/2006	Parent stated pt's right arm was red and swollen on 12/16/06.   On that day mom talked to MD by telephone and was told to put ice to area and give tylenol for pain.  Today 12/18/06 mom reports pt's right arm continue to be red and swollen but less than 12/16/06.									N	12/15/2006	12/16/2006	1	Vaccine adverse reaction.	UNK	UNK	None	Non	Non			1						1	Erythema; Pain; Swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B035AA~5~IM~RA~DTAP (INFANRIX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71032~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~Y0824-2~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MM~MERCK & CO. INC.~0821F~2~SC~LA~MEASLES + MUMPS (MM-VAX)~1	USA		Influenza
0269315	12/18/2006	CA	2.0	2	1	M	12/18/2006	Povider ordered the flu vaccinne 0.5cc. Gave the child a flu vaccinne for 18yrs and older. So I immediately notified the Clinc Director.Fluarix lot # AFLUA239BA Exp 06/30/2007									Y	11/20/2006	11/20/2006	0		UNK	UNK						1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA239BA~1~IM~RL~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269317	12/18/2006	CA	62.0	62		F	12/18/2006	Red raised are at injection site approxiatmately silver dollar size Tender to the touch									Y	12/18/2006	12/18/2006	0		UNK	UNK	Seroquel,Paxil,Wellbutrin SR, Protonix,Mysoline,nORCO-5,Maalox,Insulin,Zocor,Ritalin,Remeron,Klonopin,Rocephin,Levaquin	Pneumonia and anemia	Penicillin and rasberries, avocado and mold			1						1	Injection site erythema; Injection site swelling; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua216AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0958F~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0268683	12/19/2006	NV	42.0	41		M	12/13/2006	Severe swelling and pain in arms, high fever, nausea, headache, grand mal seizure with loss of consciousness, head injury with broken nose, hearing and vision problems, dizziness, mental confusion, muscle weakness, lethargy.  MR received from vax provider for date of vax. and f/u phone calls.  No treatment sought for AE.  Pt. seen 12/07/2006 for prescription refill for back pain meds.  Vax. received. Pt. called office on 12/11/2007 (4 days s/p vax.) to report reaction.  Office was unable to reach pt. until 12/20/2006.  Phone contacts show patient states he was not seen for his AE, but is looking for compensation.  No further records to request.			Y	Y					U	12/07/2006	12/07/2006	0	none	PUB	PUB	Meds:  Darvocet N-100, Norflex, Atarax.		PMH: COPD, right Rotator Cuff tear, low back pain, fibromyalgia, basal cell carcinoma, depression, anxiety, rhinitis.  Allergies:  Phenergan, Lortab.			1						2	Confusional state; Dizziness; Facial bones fracture; Grand mal convulsion; Head injury; Headache; Hearing impaired; Lethargy; Loss of consciousness; Muscular weakness; Nausea; Pain in extremity; Pyrexia; Swelling; Visual disturbance; Confusional state; Dizziness; Grand mal convulsion; Headache; Hearing impaired; Injury; Lethargy; Loss of consciousness; Mental impairment; Muscular weakness; Nausea; Oedema; Pain; Pyrexia; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~RA~PNEUMO (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~~UNK~IM~RA~PNEUMO (NO BRAND NAME)~2	USA	Life Threatening	Influenza
0269318	12/19/2006	NC	43.0	43		F	12/19/2006	This case was reported by a healthcare professional and described the occurrence of joint pain in a 43-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. Medical history included right hand dominant and athletic. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. Concurrent medications included Oral contraceptive (Oral contraceptive). On 02 November 2006 the subject received a dose of Fluarix in the left deltoid. On 02 November 2006, less than one day after vaccination with Fluarix, the subject experienced joint pain that felt as though the injection was given in the interarticular joint. The subject was seen by a physician and referred to an orthopedic specialist for physical therapy. The subject must work at home because of the pain. The healthcare professional considered the event was disabling. At the time of reporting, 28 November 2006, the event was worse. Follow-up information received on 14 December 2006 indicated that the subject experienced joint pain in the left shoulder starting on 02 November 2006. The pain limited shoulder mobility. The events were reportedly improved at the time follow-up was provided. In the reporter's opinion, the events were possibly related to treatment with Fluarix. It was felt that the vaccine may have been administered into a joint space.				Y				Y	N	11/02/2006	11/02/2006	0		OTH	PVT	Oral contraceptive				A0629792A	1						1	Arthralgia; Joint range of motion decreased; Arthralgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA223AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA223AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Disabling	Influenza
0269319	12/19/2006	FL	80.0	80		M	12/19/2006	This case was reported by a physician and described the occurrence of injection site pain in a 80-year-old male subject who was vaccinated with influenza virus vaccine (FluLaval) for prophylaxis. Concurrent medications included Atervastin calcium (Lipitor) and Cardiac medication. The subject has unspecified cardiac history. He received the flu injection last year without complaints. On 23 October the subject received 1st dose of FluLaval at 0.5 ml, intramuscularly in the right deltoid. That same day, the subject experienced injection site pain. Four days later, on 27 October 2006, the subject reported increased pain and swelling at the injection site. The subject also reported weakness in his right arm with progressive loss of arm above his shoulder. The physician stated that in order for the subject to lift his arm over his head he had to lift his right arm to fully extend the right arm. The physician considered the events were disabling significant (or requiring intervention) (OMIC). The subject reports significant pain and weakness when he has to lift his arm. At the time of reporting. the events were worse. In the reporter's opinion, the events are probably related to treatment with FluLaval.								Y	U	10/23/2006	10/23/2006	0		PVT	PUB	Atorvastatin calcium, Cardiac medication		The subject has unspecified cardiac history. He received the flu injection last year without complaints.		A0632024A	1						1	Asthenia; Injection site pain; Injection site swelling; Monoplegia; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F60111~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Disabling	Influenza
0269338	12/19/2006	MA	53.0	52		M	12/19/2006	11/21/2006 Fluzone vaccine, lot U2213AA expiration date 6/30/06 administered 2:10 pm intramuscularly in left deltoid, 11/22/06 11AM (less than 24 hours after flu vaccination) stated he felt unusually tired and very drained. 11/23/06 stated increased tiredness, overall did not feel good, feeling weird, unable to be more specific. 11/24/06 described self as sick, states lethargic, very painful achy muscles and joints, stated difficulty transferring from bed to chair (< 2 feet away), stated warm, had fever (did not check temperature), migraine headache, labored breathing, unable to sleep 11/24/06 (Friday night). 11/25/06 went to hospital, states developed vomiting and diarrhea while in hospital, admitted to hospital for 3 days (11/25/06, 11/26/06, 11/27/06, states IV fluids were given, CAT scan was done (pt stated he did not know results). 12/18/2006 received telephone call from company and spoke with human resource personnel who stated pt said others were ill, but indicated no one else had come forward. Human resource personnel indicated that pt had reported to manufacturer. Spoke with a representative who gave pt my name and number. 12/19/06 telephone call received from pt and VAERS form completed per protocol. Pt indicated that he heard second hand that others were ill with similar, but milder signs and symptoms and a similar time course. Pt was unable to give names of employees who were ill. Requested that pt have other employees who became ill call me.  Hospital MR received for 2 night hospital stay for c/o fatigue, abdominal pain, nausea, vomiting, black diarrhea, increased heartburn, arthralgias, myalgias, and fever.  HPI:  Pt. reports above symptoms started 1 day s/p flu shot.  Weakness and lethargy increased for several days resulting in ER admit. Pt. showed much improvement after 2 days and was d/c home. Assessment: Likely viral syndrome-improved.					Y	3			Y	11/21/2006	11/22/2006	1	Labs and Diagnostics:  CBC unremarkable, CMP with glucose of 120 and low sodium and chloride, Lyme IGG/IGM (-), H. pylori (-), stool for occult blood (-). Abd. CT showed fatty liver, distended stomach without obstruction, ? bibasilar infiltrates of lungs.	OTH	PVT	NONE Meds: Prilosec, HCTZ, Lisinopril, Doxepin, clonazapam.		PMH: Hypertension, GERD, Insomnia, Anxiety.			1						1	Arthralgia; Asthenia; Diarrhoea; Dyspnoea; Fatigue; Feeling abnormal; Feeling hot; Insomnia; Lethargy; Malaise; Migraine; Myalgia; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2213AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0269348	12/19/2006		52.0	52		M	12/01/2006	Patient has fever and lots of swelling in the Left arm, from shoulder to the wrist and a rash.									Y	11/28/2006	11/29/2006	1	NONE	OTH	PUB	NONE	NONE	NONE			1						1	Pyrexia; Rash; Swelling	FLU3~SANOFI PASTEUR~20060919~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0486F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0269349	12/19/2006	MN	5.0	5		M	12/13/2006	12/4/06 96 temp, 47lbs 12.8 oz. On 12/4/06 patient had immunizations in clinic. Right thigh had flu and MMRV and Left thigh had Dtap and IPV. On 12/5/06 in the evening child woke up per mother with hives on his face and neck. Treated with Benadryl. Mother reported left thigh had redness lasting 2 days and now has different rash. 12/13/06 left thigh 2-3 inches area of confluent lesions pattern pink red rash with raise border, bumpy, similar rash on the right thigh about 1x1 inch.										12/04/2006	12/05/2006	1		OTH	OTH	Desonide 0.05% ointment	NONE				1						1	Rash; Skin ulcer; Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC146035AA~5~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2244AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0240~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1093F~1~SC~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA		Influenza
0269351	12/19/2006	OR	4.0	4		F	12/11/2006	2 days after immunization had seizure episode. partial seizure. Lasted 3 to 5 seconds and has been eating normal ever since with normal exam today 12/11/06.				Y					Y	12/08/2006	12/10/2006	2	Have ordered EEG to rule out seizure disorder	PUB	PUB	Vitamins with fluoride	NONE	NONE			1						1	Convulsion	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71639~3~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0269352	12/19/2006	MS	57.0	56		M	12/15/2006	Patient woke up morning after injection with erythematous itchy rash all over body. His face, neck and chest appeared to be sunburned. Treated by his private physician with Medrol dose pack. Improvement in rash within 2-3 days.				Y					Y	12/11/2006	12/12/2006	1		PVT	PVT	NONE	NONE	diverticulitis			1						1	Erythema; Pruritus; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72224~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0269354	12/19/2006	TN	3.0	2	.9	F	12/08/2006	Rage episodes x 3. Began with disorientation.									Y	10/13/2006	10/29/2006	16	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Anger; Disorientation	FLU3~SANOFI PASTEUR~U2174HA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269355	12/19/2006	TX	1.7	1	.7	F	11/07/2006	Mother phoned to say the child has broken out in a rash all over body. Questioned in regard to anaphylactic shock and denies any other problems at this time. Referred to physician.				Y					U	11/07/2006	11/07/2006	0	UNK	PUB	PUB	UNK	NONE	No known medical problems or allergies.			1						1	Rash	FLU3~SANOFI PASTEUR~U2174HA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269356	12/19/2006	LA	75.0	74		F	12/08/2006	Pain in left shoulder-unable to left arm. Throbbing periodic pain severe in lower arm. Injection administered in left arm.										11/28/2006	12/05/2006	7	NONE	PUB	PUB	Propronolol and synthroid	NONE				1						1	Joint range of motion decreased; Pain	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0269357	12/19/2006	MN	34.0	33		F		Rash beginning on right arm. Swelling both arms and face. Throat tightness. Treated with Benadryl and Prednisone.				Y					Y	12/06/2006	12/06/2006	0		PUB	PUB	NONE	NONE	NONE			1						1	Rash; Swelling; Throat tightness	FLU3~SANOFI PASTEUR~U2282AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269358	12/19/2006	AZ	8.0	8		M	12/08/2006	Shot site red, swollen, warm to touch									Y	12/06/2006	12/06/2006	0		PVT	PUB	Albuterol inhaler PRN	NONE	NONE			1						1	Erythema; Feeling hot; Swelling	FLU3~SANOFI PASTEUR~U2285AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269359	12/19/2006	CA	1.66	1	.7	F	12/14/2006	4 1/2 x 5 cm area of induration right thigh, mild redness.									U	12/12/2006	12/12/2006	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Erythema; Injection site induration	DTAP~SANOFI PASTEUR~C2649AA~UNK~IM~~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2307AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0741F~2~IM~~HEP A (VAQTA)~1	USA		Influenza
0269360	12/19/2006	NJ	3.0	2	.9	M	12/11/2006	Right arm with 10x12cm redness, warmth and swelling over deltoid. Axilla red with 1.5cm x 1.5 cm node palpable. Pink/blush up whole Right side of neck. No significant pain to palpation.									Y	11/29/2006	11/30/2006	1		PVT	PVT		NONE	NONE			1						1	Erythema; Feeling hot; Palpitations; Swelling	FLU3~SANOFI PASTEUR~U2197AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269361	12/19/2006	NY	59.0	58		F	12/11/2006	Patient received vaccine on 12/6/06. Prior to vaccine patient was free from symptoms. No complaints. Patient called H/U to complain of pain at injection site and down arm to wrist. Deep pain/ache. Denies redness/swelling.									N	12/06/2006	12/07/2006	1		OTH	OTH	Cymbalta, Bencar	NONE	hyperparathyroidism, Penicillin, bee stings, nuts, Arthric Drugs.			1						1	Pain	FLU3~SANOFI PASTEUR~U2284AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269363	12/19/2006	KS	4.0	4		M	12/07/2006	Patient was given 2 flu shots at the same time by different RN's. Should have received 1 polio and 1 flu shot. Patient checked 12-7-06 and 12-8-06: minimal induration (<5mm) at flu injection sites. Facility called CDC Immunization hotline medical provider no increase in reaction with an increased number of flu doses even if given at the same time.									Y	12/06/2006	12/06/2006	0		PUB	PUB	NONE	NONE	NONE			1						1	Injection site induration; Wrong drug administered	DTAP~SANOFI PASTEUR~U1857AB~5~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2275AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08635K~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0269364	12/19/2006	CT	53.0	53		F	12/07/2006	Cheeks bright red and hot to touch, chest and rest of face, deep pink, itchy eyes, tingling lips, started mid-afternoon, continued for about 24 hours.				Y					Y	11/29/2006	11/29/2006	0	NONE	OTH	PUB	Dovizn	HIGH BLOOD PRESSURE	Allergic to anti-inflammatories, some antibiotics, sulphites			1						1	Erythema; Paraesthesia; Pruritus	FLU3~SANOFI PASTEUR~U2284AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269365	12/19/2006	CO	45.0	45		F	12/10/2006	Right sided Bell's Palsy 01/18/07-per staff at Dr.'s office, spoke with patient on 01/17/07-Bell's palsy resolving, right eyelid droop remains at this point with some sensitivity to light, wind and cold. Staff will follow up with patient in 3 weeks.  01/22/07-records received and reviewed.  DX: Bell's Palsy, 90% recovered. Has some residual eye dryness but can close it effectively. Sudden onset with right sided facial numbness and weakness. Pain in right anterior neck.								Y	N	10/24/2006	11/05/2006	12		PVT	PVT	None	No	None			1						1	Facial palsy	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Disabling	Influenza
0269367	12/19/2006	MO	39.0	39		F	12/07/2006	Patient received Flu vaccine, waiting approximately 10 minutes, started having chest tightness. Patient states feels like being hugged.				Y					U	12/07/2006	12/07/2006	0		PUB	PUB		UNK	UNK			1						1	Chest discomfort	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA240BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0269368	12/19/2006	NY	39.0	39		F	12/15/2006	Rash on back, neck, arms/hands, feet. Benadryl 25mg PO given at 9:15 am.									Y	12/15/2006	12/15/2006	0		OTH	OTH	PREVACID, ZOLOFT	NONE	Hypothyroid, Depression			1						1	Rash	FLU3~SANOFI PASTEUR~U2284AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269370	12/19/2006	CA	59.0	59		F	12/12/2006	Above named client received Influenza vaccine on 09Dec2006. On 10Dec2006 at 0500, client noted red rash to abdominal region and up toward mid-torso with itchiness and slight fever. Client did not complain of shortness of breath, she did not seek treatment on 10Dec2006. On 12Dec2006 client presents to this clinic complaining of some areas of redness, but with heightened redness and increased itchiness. Also reservist complain of increased itchiness to bilateral arm without noticeable rash, client does not complain of shortness of breath and speaks in full sentences. Advised patient and referred to nearby medical facility community hospital/personal MD (of client)									U	12/09/2006	12/10/2006	1		MIL	MIL			Sulfa-based medications, codeine			1						1	Erythema; Pruritus; Rash	FLU3~SANOFI PASTEUR~U2308AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269372	12/19/2006	OK	72.0	72		M		Day following injection: sore throat, runny nose. Two days following coughing with congestion in chest lasting approximately 2 weeks, chills, headache, also congested sinuses. Prescribe Cephalexin 500 mg; GPN/Phenylep 600, Benzonatate 200 mg.				Y					Y	10/31/2006	11/01/2006	1		PUB	PUB		NONE	Hypertension			1						1	Chills; Cough; Headache; Nasal congestion; Pharyngolaryngeal pain; Rhinorrhoea; Sinus congestion	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0269373	12/19/2006	IN	13.0	13		F	12/12/2006	Patient given Td instead of ordered Tdap.										12/11/2006				PUB	UNK						1						1	Wrong drug administered	FLU3~SANOFI PASTEUR~U2286AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2170AA~UNK~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TD~AVENTIS PASTEUR~U1704AA~UNK~IM~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~0788R~UNK~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0269375	12/19/2006	WI	1.43	1	.4	F	12/06/2006	This child presented at ER 12/2/06 with possible seizures. The doctor at Red Cedar Medical Center diagnosed gastroenteritis, dehydration and low blood sugar was cause of seizure. Mother reports child started vomiting 11/29/06 at 7:30pm and continued until she presented at ER 12/2/06. Rehydrated with IVs and given Albuterol updraft for asthma. Released after treatment 12/27/06-records received and reviewed for ED visit HX of decreased oral intake for 24 hours prior to ER visit, seizure prior to ER visit. Temp 99.2.  Assessment: gastroenteritis, probable mild dehydration and low blood sugar likely enough to cause seizure.				Y					Y	11/28/2006	11/29/2006	1	Glucose 51.	PUB	UNK		no	diagnosed with asthma in 10/05			1						1	Blood glucose decreased; Convulsion; Dehydration; Gastroenteritis; Vomiting	FLU3~SANOFI PASTEUR~U2220AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB099CB~1~IM~RA~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~AHB08649E~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0269376	12/19/2006	PA	1.01	1	.0	F	12/11/2006	Patient with fever, rash, diarrhea 12/7/06. Tylenol administered for fever of 101.3 rectal 12/7/06. Prescribed Cephalexin 250/5 mg suspension, 1 tea spoon twice daily for ten days. 12/11/06 recheck cellulitis. Patient improving. Will continue antibiotics until directed.										11/27/2006	12/07/2006	10	Urine culture, routine urine, CBC/Diff, blood culture	PUB	PUB	POLYTRIM OPTHALMIC CEPHALEXIN 250/5	Acute Respiratory symptoma-chest symptoms, URI				1						1	Cellulitis; Diarrhoea; Pyrexia; Rash	FLU3~SANOFI PASTEUR~UT2176JA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0651F~1~IM~LL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~0823F~1~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0269377	12/19/2006	IA	1.07	1	.1	M	12/19/2006	Patient given expiration date 12/7/06. Also additional Varicella immunization given. ProQuad thought to only be MMR.									Y	12/15/2006	12/15/2006	0	NONE	PVT	PVT		NONE	NKDA			1						1	Medication error	FLU3~SANOFI PASTEUR~U2174HA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269378	12/19/2006	TX	55.0	55		F	12/19/2006	Hives face and neck/mild/1day/no treatment.									Y	12/05/2006	12/07/2006	2		OTH	PVT	NONE	NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2284AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269379	12/19/2006	TX	32.0	32		M	12/19/2006	The day after vaccine was given I broke out in hives. They didn't really bother me or itch really bad, but enough to concern me. On upper body/ lasted 3-4 days.									Y	12/05/2006	12/06/2006	1		OTH	OTH	NONE	NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2284AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269380	12/19/2006	MD	9.0	10		M	12/19/2006	Headache started hours after school ended. Motrin did not help. Doctor's appointment November 1st, no meds given. No fever, no body ache.									Y	10/30/2006	10/30/2006	0		OTH	PUB	NONE	NONE				1						1	Headache	FLUN3~MEDIMMUNE VACCINES, INC.~500438P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0269381	12/19/2006	NY				F	12/18/2006	12/7/06- Call from doctor reported, states patient was seen and treated for cellulitis at injection site. 12/7/06 attempted to contact patient at number listed No longer in service. 12/11/06 call to doctor reported, states she will have patient call me. 12/12/06 Have not received call from client. Call to doctor office number 12/18/06 no call from either physician or patient for status.									U					PUB	UNK		NONE stated				1						1	Cellulitis; Injection site reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA213AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269404	12/19/2006	GA	66.0	66		F	12/18/2006	12-15-06 small red area (dots) appeared like unconnected rash over the next three days. Closed up to make hard knot. Red area about 3x. This area is 3 below injection site. 12-16-06 patient had fever, stiff neck, unable to get up except as necessary. 12-17-06 was better still but still had fever, weakness and felt really bad.				Y					Y	12/15/2006	12/15/2006	0		PUB	UNK		NONE	hypothroidism-takes 0.75 mg synthyroid			1						1	Asthenia; Erythema; Injection site nodule; Musculoskeletal stiffness; Pyrexia	FLU3~SANOFI PASTEUR~U2284AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0001F~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0269405	12/19/2006	MI	51.0	51		M	12/19/2006	Emp was given flu vaccine at work on 12-13-06.  Emp went home and started with headache and a stiff neck.  sxs worsened on 12-14-06 with a temperature spiking to 102 degrees.  Stiff neck was increasing worse.   Employee was taken to Hospital on 12-14-06 by his wife.  Emplyee was given Cat scan of head and neck, blood work and spinal tap.  It was reported to employee by the ER doctor that he did not have menigitis.  Employee was given Motrin, valium and darvocet for pain. Employee was discharged from the ER to home after 8 hours.  Employee wife called work clinic on 12-18-06, advising that employee was feeling better each day after he received treatment on 12-14-06 at the ER.   Employee off work due to Christmas vacation but will report to work as usual on 1-2-2007.  The health services department has requested that employee report to medical upon reutrn to work from vacation to have evaluation and follow up by the plant physician.  Employee agreed to do this				Y					Y	12/13/2006	12/13/2006	0	Cat Scan of head and neck/ spinal tap and blood work.   Verified that the cat scan and spinal tap were normal.	UNK	UNK		none	none			1						1	Headache; Musculoskeletal stiffness; Pyrexia	FLU3~SANOFI PASTEUR~U2260AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269413	12/19/2006	NM	43.0	43		F	12/13/2006	Return 2 1/2 hours after recieving Vaccine c/o itching-slight rash to neck-chest and arms.  Denied SOB, difficulty breathing.  AXOX3 Benadryl 50 mg PO given.  Applied Caldryl lotion to areas.  Advised to call PCP from Clinic which she did.  F/U visit at 2PM.									U	12/13/2006	12/13/2006	0		UNK	UNK	n/a	none				1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U2284AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269414	12/19/2006	NY	61.0	61		F	12/08/2006	onset of cough, runny eyes, headache, inside of mouth hurt, difficulty breathing, ache all over. Went to ED at 4:30pm felt reaction to vaccination. Patient took Benadryl at home after the ED visit.				Y					Y	12/07/2006	12/07/2006	0	none	UNK	UNK	would not reveal	None	Ampicillin- hives			1						1	Cough; Dyspnoea; Eye discharge; Headache; Oral pain; Pain	FLU3~SANOFI PASTEUR~U2275AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269415	12/19/2006	PA	75.0	69		F	12/19/2006	Had some swelling evening of 11/29/06, put ice on left arm. Has had increased pain in left arm since injection given.  No warmth or swelling in left arm at present.  Is unable to sleep because of severe pain in left arm when lying down.  Arm is painful when she lifts left arm.  Is taking Tylenol.  Saw physician on 12/8/06 - no treatment given.  Has not had a reaction to influenza vaccine in the past.				Y						11/29/2006	11/29/2006	0		UNK	UNK						1						1	Pain; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA242BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0269417	12/19/2006	IA	4.0	4		M	12/19/2006	Left deltoid - redness and swelling of the left shoulder, down to about the mid-upper arm   No fever.  Happy, playful, eating and drinking normally.   Mother applied ice pack				Y					Y	12/01/2006	12/01/2006	0		UNK	UNK	NA	NA	NA			1						1	Injection site erythema; Injection site swelling	DTAP~SANOFI PASTEUR~C2490AA~5~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2283AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~PASTEUR MERIEUX CONNAUGHT~20306~4~SC~LA~POLIO VIRUS, INACT. (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0269419	12/19/2006	TX	3.0	3		M	12/19/2006	Beginning 4 hours after Fluzone and Hepititis A vaccines began to vomit and continued for the next 4 hours. Approximately 12 hours later started to vomit again and continued for another 3 hours. No fever, no rash. Home symptomatic treatment given at first and then Phenergan 12.5mg q 4-6 hours prn. No further complaints of vomiting.									Y	12/14/2006	12/14/2006	0	None	UNK	UNK	None	None	None			1						1	Vomiting	FLU3~SANOFI PASTEUR~U2282AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1209F~2~IM~RL~HEP A (VAQTA)~1	USA		Influenza
0269420	12/19/2006	FL	55.0	55		F	12/19/2006	developed redness warmth and knot at injection site 12/7/06, treated with warm compress and tylenol,treated 12/09/06 at walk in center for cellulitis with oral and injectable antibiotics,followed up 12/13/06 at PCP, arm swelling decreased.				Y					Y	12/06/2006	12/07/2006	1	CBC normal, Venous dopplar u/s negative	UNK	UNK	alprazolam,protonix,ambien,boniva,evista,topamax,zomig,vagifem,fluticasone propionate,lexapro,effexor,simethicone,carafate,depakite,quinine sufate,diclofenac sodium cr	URI,allergic rhinitis,anxuety,arthritis,fatigue,hypokalemia,breast cancer,macrocytosis,migraine headache,muscle cramps in the calf,osteopenia,palpitations	macrobid,tetracycline, see illness list in box 18 for diagnosed medical conditions			1						1	Cellulitis; Injection site erythema; Injection site mass; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2250AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0882f~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0269426	12/20/2006	MN	66.0	65		M	12/15/2006	Behavior changes: 1. Confusion -lasted all evening see below. A. Loss of time as related to events 5pm. B. Frustration 6pm. C. Anger 6:30pm.									Y	11/29/2006	11/29/2006	0		UNK	PVT		NONE	NONE			1						1	Abnormal behaviour; Agitation; Anger; Confusional state; Mental impairment	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0269427	12/20/2006	VA	64.0	63		M	12/18/2006	Complained of off and on pain in left arm since he received a flu shot on 12/6/06.				Y						12/04/2006	12/05/2006	1		OTH	PUB	Atenolol, Acebutolol, Lisinopril	High blood pressure	Nitrous oxide			1						1	Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA240BA~1~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0269428	12/20/2006	IA	1.54	1	.5	F		At noon at home, started to hold right arm tight to her body, then held arm tight to her head. Held by mother, child's head was limp, then child fell asleep. Mom woke child after 15 minutes, difficult to awaken and child was sweating and pale. Took to ER-recovered and went home. Symptoms developed again 2 hours later and child returned to ER for CT scan, sedation and blood workup. Mom reports client afebrile during this time.  ER doctor told parents Textbook signs of MMR reaction.				Y					Y	12/14/2006	12/14/2006	0	Blood cultures, CT scan of head.	PUB	PUB	NONE	NONE	NONE			1						1	Hyperhidrosis; Hypotonia; Pallor	DTAP~SMITHKLINE BEECHAM~AC14B035AA~4~~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2220AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0201F~1~~RA~HEP A (VAQTA)~1|HIBV~MERCK & CO. INC.~0280F~3~~LA~HIB (PEDVAXHIB)~1|MMRV~MERCK & CO. INC.~0827F~1~~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08672H~4~~LA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0269429	12/20/2006	MN	1.56	1	.6	M	12/13/2006	Patient developed 103.3 fever day after immunization. Refused liquids. Did not want to put weight on Left leg. Does have 1.5cm x 1.8cm redness at injection site of left lower thigh. Did throw up Tylenol. Irritable.									Y	12/12/2006	12/13/2006	1	White blood count 12.1, ears and throat normal per physician	PVT	PVT	NONE	NONE	NONE			1						1	Erythema; Irritability; Muscular weakness; Pyrexia; Vomiting	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B006BA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2202AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0280F~3~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08670A~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0269442	12/20/2006	NY	60.0	60		F	12/20/2006	Redness, pain, swelling below injection site.										12/18/2006	12/19/2006	1		PVT	UNK		Bronchitis	Type II diabetes mellitus, emphysema			1						1	Erythema; Pain; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72003~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0988F~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0269443	12/20/2006	VA	44.0	44		F	12/20/2006	Pain started in right arm (shoulder) and moved down to fingers-pain was not relieved by Motrin. Pain decreased that night. Now has constant pain and decreased mobility of arm. Also muscle weakness due to pain.				Y					N	11/16/2006	11/16/2006	0		OTH	PVT		NONE	NONE			1						1	Joint range of motion decreased; Muscular weakness; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70738~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0269444	12/20/2006	LA	1.54	1	.5	F	12/20/2006	Fever up to 103F about 4 hours after receiving the vaccine followed by a febrile seizure.  1/9/07 Received medical records from hospital which reveal patient was seen in ER on 12/14/06 afternoon after receiving flu vax in am.  Patient had awakened from nap with rash & parent found him seizing.  Temp 103.6 in ER.  Patient noted to be post ictal in ER. Final DX: febrile seizure s/p flu vaccine; mild bronchiolitis.				Y					Y	12/14/2006	12/14/2006	0	NONE LABS: WBC 19.7, segs 58, lymphs 25, monos 14, eos 0.7.  Chem & UA WNL.  CXR revealed mild bronchiolitis.	PVT	PVT	Zyrtec 1mg/ml 2.5ml by mouth	NONE	NONE			1						1	Febrile convulsion; Pyrexia; Convulsion; Pyrexia	FLU3~SANOFI PASTEUR~U2250AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2245AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0269447	12/20/2006	TN	49.0	49		M	12/20/2006	Guillian-Barre syndrome, loss of sensation in extremities and motor movement coordination 10 days after influenza vaccination.  Treated with IVIG 24 gm x 1 then 42 gm x 4 doses.  12/29/06 Received partial medical records from hospital with note that d/c summary not available at this time.  Admitted on 12/13/06.  H&P indicates patient with increased back pain, numbness of hands & feet, facial numbness, headaches & frequent falls prior to admit.  Consults by neurosurg, neuro.  Admit Dx: carpal tunnel syndrome, polyneuropathy possible Guillain Barre Syndrome  2/2/07 Received additional records from hospital which reveal patient experienced lower extremity weakness & falls from 12/13-12/21/06.  Also had weak cough & poor swallowing but did not require ventilator.  Day before d/c, developed fever & CXR showed LLL infiltrate.  Started IV antibiotics & was to continue oral antibiotics upon transfer to rehab facility. FINAL DX: Demyelinating polyneuropathy, c/w Guillain Barre Syndrome; HTN; poorly controlled diabetes; chronic pain; & pneumonia.				Y	Y	8			Y	11/30/2006	12/10/2006	10	Vit B-12 714 pg/mL Myasthenia gravis AChR Ab 0.09 nmol/L, 14% LABS: MRI x 2 prior to admit were read as WNL.  WBC 15.8, neutros 82.5, lymphs 11.1, mono 6.1, eos 0.2, HGBA1C 8.2, Na 133, SGOT 62, SGPT 139 LABS: EMG revealed GBS per d/c summary but no copy of report .  T/C to medical records to request EMG report.  CXR of 12/21 reveals left lower lobe atelectasis vs pneumonia	UNK	UNK		Chronic back pain	Hepatitis C, type 2 diabetes mellitus, hypertension PMH: obesity, Hep C, cirrhosis, HTN, type II DM, chronic back pain, cigarette smoker			1						1	Guillain-Barre syndrome; Hypoaesthesia; Hypokinesia; Myasthenic syndrome	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71210~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0269448	12/20/2006	FL	28.0	28		F	12/20/2006	Face felt hot, appeared reddened.  Diphenhydramine 25 mg given at Employee Health Center.									Y	12/12/2006	12/12/2006	0	None.	UNK	UNK	Ultra; Lyrica; Mirena; Vicodin; Enbrel injection	Had a cold one week prior but had recovered.	Allergies:  penicillin, shellfish. Medical conditions:  psoriatic arthritis; psoriasis.			1						1	Erythema; Hot flush	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601411~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0269452	12/20/2006	AZ	10.0	10		M	12/20/2006	Hip synovitis right more than left. Unable to bear weight for 48 hours 12/21/06 Received medical records from hospital which reveal patient admitted 12/13-12/14/06 following 2 days of right hip pain with weight bearing & also had some pain left hip.  Pain kept patient awake at night.  No illness or trauma.  Flu vax 3 days prior to symptoms.  Exam revealed right hip with pain when flexed at 90 degrees, pain with extrenal rotation beyond 60 degrees and pain increased when hip internally rotated.  No pain when flexed or at rest.  Treated w/anti inflammatory & pain meds overnight & was able to walk next day.  D/C to home to be f/u as outpatient. Final Dx: Synovitis of hip/ss				Y	Y	1			Y	12/07/2006	12/10/2006	3	CBC normal ESR 23 X ray and CT of hip - normal LABS: WBC 11,000.  ESR 23.  Chems are WNL.  Xray showed no abnormalities.  CT of hips was WNL.	UNK	UNK		No	No			1						1	Hypokinesia; Synovitis	FLU3~SANOFI PASTEUR~u2285aa~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0269453	12/20/2006	WA	0.2	0	.2	F	12/20/2006	I was giving 2 month immunizations  & for unknown reasons, encluded the flu immunization. I not sure  how this happened.  No excuse.  There were no problems  noted because of the immunization on f/u visit other than the continued raspy breathing.  Patient was referred to a pediatrician for the breathing problem.									Y	11/13/2006	11/13/2006	0		UNK	UNK	No	No, other than grunting breathing since  birth- considered variant of normal - 10/9/2006.	Grunting breathing since birth			1						1	Respiratory disorder	DTAP~SANOFI PASTEUR~AC14B018AA~1~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U220BB~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0144R~2~IM~RL~HEP B (RECOMBIVAX HB)~1|HIBV~SANOFI PASTEUR~UE695AA~1~IM~LL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~Y1051-2~1~IM~LL~POLIO VIRUS, INACT. (POLIOVAX)~1|PNC~PFIZER\WYETH~B08655B~1~IM~RA~PNEUMO (PREVNAR)~1	USA		Influenza
0266512	12/21/2006	CO	82.0	82		M	12/21/2006	Extreme aching within minutes of shot. Fatigue, nausea, and dehydration starting 11/4. Extreme weakness, weight loss, nausea observed on 11/6. On 11/7 had temperature of 103, had lost 11 pounds since physical on 10/31/06, high creatin level, too weak to tie shoes, eyes very red, other symptoms of infection. Admitted to emergency room about 20:00 11/7. Condition deteriorated to death. Cause of death listed as sepsis with pneumonia and acute renal failure.	Y	11/09/2006		Y	Y	2			N	11/04/2006	11/04/2006	0	There were continuous tests done from about 16:30 on 11/7 until death on 11/9 with cultures grown after 11/9. As near as anyone has told me there was no cause of the infection definitely identified other than the flu shot. There was another VAERS report done on 11/10 or 11/13, but I haven't been able to access it to date.	UNK	UNK	None	None. Passed physical on 10/31/06. Quoted to Dr. I feel great. No complaints or problems observed by son or daughter-in-law who patient lived with prior to flu shot on 11/4/06	None nor was he taking any medications			1						2	Alanine aminotransferase increased; Aspartate aminotransferase increased; Blood creatine phosphokinase increased; Malaise; Platelet count decreased; Renal failure; Respiratory failure; White blood cell count increased; Asthenia; Blood creatinine increased; Dehydration; Fatigue; Infection; Nausea; Ocular hyperaemia; Pain; Pneumonia; Pyrexia; Renal failure acute; Sepsis; Weight decreased	FLU3~SANOFI PASTEUR~U2255AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2255AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0269456	12/21/2006	PR	0.55	0	.5	M	12/11/2006	Generalized wheals shortly after administration of vaccine. Irritability. Treatment Benadryl IM, SoluMedrol IM 01/18/07-records received and reviewed, generalized wheals, treated with Benadryl and SoluMedrol IM				Y					Y	12/11/2006	12/11/2006	0		PVT	PUB		No	No			1						1	Irritability; Urticaria	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B084CA~1~IM~~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2176KA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08674D~3~IM~~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0269457	12/21/2006	MA	49.0	48		F	12/21/2006	Approximately 15 hours after vaccine administered reported feeling sick-very tired generalized body aches. Left work, took Tylenol by mouth and slept all day 12/19/06 and night. Awoke 12/20/06-felt better feels like she is getting a cold though.									Y	12/18/2006	12/19/2006	1	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Fatigue; Malaise; Pain	FLU3~SANOFI PASTEUR~U2279AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269461	12/21/2006	SC	67.0	66		M	11/16/2006	2nd Flu shot this season (due to recall vaccine on 10/20/06) same arm right upper arm, red, swollen, warm to touch (whole upper arm).									Y	11/14/2006	11/14/2006	0		PUB	PUB	Carafate QD, Zegrid BID, Reglan QD	NONE	Esophageal and stomach cancer, finished chemotherapy 6 months ago.			1						1	Erythema; Injection site warmth; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72000~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0269465	12/21/2006	CT	0.53	0	.5	M	12/18/2006	One day after immunizations child developed irritability - swelling at injection shot. Fever up to 102 degrees.				Y					Y	12/11/2006	12/12/2006	1		PUB	PUB		NONE	NONE			1						1	Injection site swelling; Irritability; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B060BA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2176BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08649H~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0269466	12/21/2006	WA	68.0	68		F	12/06/2006	Never stopped hurting from time of shot. Swollen, red, hard upper arm closer to elbow. Sent to MD. Hurt left arm to lift.										12/04/2006	12/05/2006	1		PUB	PVT		NONE	Increase BP, Cholesterol 4 years ago, small stroke.			1						1	Erythema; Joint range of motion decreased; Pain; Swelling	FLU3~SANOFI PASTEUR~U2281AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0620F~7+~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0269467	12/21/2006	WA	68.0	68		M	12/06/2006	Ached and felt like getting sick with something then arm swollen and red. But not hard, hurts to lift arm. Says not as bad as his wife's. Returned to MD.										12/04/2006	12/04/2006	0		PUB	PVT	Lipitor 10 mg/day, Norvasc 10 mg/day	NONE	NONE			1						1	Erythema; Pain; Swelling	FLU3~SANOFI PASTEUR~U2281AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0620F~7+~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0269468	12/21/2006	MT	55.0	55		F	12/13/2006	Right shoulder joint ache continuous but notices more in arm a.m. and p.m. Client received her flu shot on 11/14/2006 at approximately 1:30 pm in her right deltoid of FluLaval manufactured was reported, Lot#2F600311, expiration date 7/07. Saw her again on 11/22/06 while I was giving flu shots to her co-workers. She states her right shoulder joint started aching the next day, 11/15 and has ached ever since. General ache in joint and around back of neck with increased awareness of aching in the morning and evening. She is right handed. Hurts to raise arm above shoulder height. Shoveled snow yesterday with increase pain afterwards. Approximately ten years ago she received a cortisone injection to the right shoulder for rotator cuff with good results from injection, no problems with shoulder since that time. Treatment since 11/15 has been Ibuprofen 600 mg at 5 and 10 pm (States it makes her tired so she can not take it during the day) and Aspirin-cream at bedtime. Suggested ice/heat, rest of shoulder, and above medications. No swelling, redness or any abnormal findings on exam. Will follow up in a few days. 11/28/2006 consulted with MD about above situation then called client. No improvement with shoulder. MD visited with her via phone then prescription for Prednisone 40-40-20-20 20mg every day for 5 days ordered and called into pharmacy. 12/4/06 at 3:10 pm follow up call to client. States it still aches, the medication didn't make a difference. Last dose taken Friday, December 1st. Phone consult with MD after visiting with client with return call to her at 3:30 pm. Recommended to follow up with her doctor, if shoulder doesn't improve. I will follow up with a form for the client in the near future.				Y					N	11/14/2006	11/15/2006	1	NONE	OTH	PVT	NONE	NONE	NONE			1						1	Arthralgia; Joint range of motion decreased; Neck pain; Shoulder pain	FLUX~UNKNOWN MANUFACTURER~2F600311~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0269478	12/21/2006	GA	65.0	65		F	12/21/2006	Guillian-Barre Syndrome Information received from the annual follow up states patient last visit was 8/17/07, diagnosed with hepatic cancer.					Y				U	10/20/2006	12/18/2006	59		PUB	PUB						1						1	Guillain-Barre syndrome; Neoplasm malignant	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71210~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0269479	12/21/2006	PA	51.0	51		M	12/20/2006	Hospitalized 12-15-06 with a diagnosis of Guillain Barre - On a ventilator with Respiratory Complications.  1/22/07 Received medical records from hospital which reveal patient admitted 12/15/06-1/12/07 for dizziness, ascending numbness & tingling of his hands & feet for a couple of days.  Had been seen in outlying hospital ER & released 3 days prior to admit w/o diagnosis.   Patient stated he had viral infection for a few days & felt lousy.  Patient also stated he received his first & only flu vax on 11/30/06.  On admission, CPK/MB were very elevated.  Neuro, cardio, pulmo, nephro, ENT & GI consults were obtained.  Was areflexia throughout & had stocking/glove distribution paresthesia.Patient developed respiratory distress.  Treated w/plasmaphoresis & IVIG. Patient was trached & had G tube placement.  Developed MRSA URI, UTI & sepsis.  Patient was transferred to Special Care Unit upon d/c from ICU on 1/12/07. FINAL DX: Axonal Guillian Barre Syndrome. Per information received from annual follow up,  full social security disability was granted in June 2007. Was seen in Outpatient theapy and discharged 7-26-07. Was hospitalized in May with a DVT. Has pain in his feet-fells they are asleep all the time. Walks with a cane. Is indepent in self care (struggles with his shoes and socks). He can't sit, stand or walk for very long.				Y	Y		Y		Y	11/30/2006	12/14/2006	14	LABS: CK/MB 14.47, CK 1134.  CXR & CT of head were WNL. WBC on admit was 11.06.  CSF glucose 89 & protein 32.	PVT	OTH	UNK		PMH: heavy cigarette smoker (2 ppd), newly dx HTN, obesity.			1						1	Blood creatine phosphokinase increased; Chest X-ray normal; Guillain-Barre syndrome; Respiratory disorder; White blood cell count increased	FLU3~SANOFI PASTEUR~U2280AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0269480	12/21/2006	NY	6.0	6		M	12/21/2006	6 X 9 area or erythema on right upper extremity, 100.8 temperature orally.				Y						12/19/2006	12/19/2006	0	NONE	OTH	OTH	PPD	NONE	Allergic rhinitis, dairy, developmental delay			1						1	Erythema; Pyrexia	DTAP~SANOFI PASTEUR~C2489AA~4~IM~LL~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500437P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~20018~3~IM~RA~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0269483	12/21/2006	MA	51.0	51		F	12/21/2006	Approximately 20 hours after flu shot given, developed migraine headache, pain back and legs, nausea, no vomiting, decrease appetite - treated with Tylenol, rest and heating pad. Did not seek medical attention. Symptoms lasted approximately 36 hours, still does not feel better.									Y	12/18/2006	12/19/2006	1		PUB	PUB	NONE	NONE				1						1	Back pain; Decreased appetite; Headache; Migraine; Nausea	FLU3~SANOFI PASTEUR~U2279AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269490	12/21/2006	NY	20.0	20		M	12/21/2006	Patient went home after work and took a nap; awoke around 8PM with the following symptoms: Headache (24 hrs); Diarrhea (18 hrs); Vomiting (18 hrs); Nausea (6 hrs).  Reported to Medical at 11AM following day. Afebrile (98.3) with symptoms subsiding a little.				Y					Y	12/02/2006	12/02/2006	0		MIL	MIL		None reported	None per Medical Record			1						1	Diarrhoea; Headache; Nausea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500438P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0269493	12/21/2006	MN	53.0	53		F	12/21/2006	Client reports pain in left upper arm which started 12/15/2006 after she received a vaccination in that area.  The pain has continued for 1 week.  Client reports she has pain whenever she lifts her left arm.  No redness/swelling noted per this nurse upon visual exam.  Client has been taking Tylenol 325mg/tab, 2 tablets, about every 6 hours since the pain started on 12/15.									U	12/15/2006	12/15/2006	0	None	UNK	UNK	Headache tablets	None	Latent Tuberculosis Infection, back pain & joint pain--? arthritis			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U2187AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB166AA~1~IM~RA~HEP B (ENGERIX-B)~1|TDAP~SANOFI PASTEUR~C2609AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0269497	12/21/2006	NH	49.0	49		F	12/21/2006	Approx 1-2 weeks after injection, developed bursitis in Left shoulder.  At time of injection pt had no pain, swelling, bruising or reddness.  Pain continues at this time.									N	11/03/2006	11/14/2006	11	none	UNK	UNK	Zyrtec, Synthroid,Lipitor, Flonase,Singulair, Lexapro	None	None			1						1	Bursitis; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~AFLUA231BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0269498	12/21/2006	NY	39.0	39		F	12/21/2006	Pt received flu shot 10am, called agency @2:10 pm. Stated had hives and itching.Hx ofBee sting allergy.went to see pt,hives on arms,upper chest,face and was diaphoretic,given 0.3cc epiSC,patient works in factory,worked with walnut wood for the first time day before,stated she had same S+S yesterday while working. Employer is now aware of the walnut issue.The rescue squad was called initially, at arrival 5 mins after epi dose her BP136/78, P 98.She refused  tx to Emerg Rm, Advised to take Benadryl when she  got home.She appeared stable when I left.   Pt received flu shot at her work site,given by a RN									Y	12/20/2006	12/20/2006	0		UNK	UNK		None known	Allergy to bee sting			1						1	Hyperhidrosis; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2279AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269502	12/21/2006	PA	55.0	55		M	12/21/2006	Within 16 hrs experienced severe lower back pain, lasted couple days, still experience intermitant light headaches, intermitant upset stomach, intermitant pain in side, (prior to flu shot had no symptoms),  have not sought medical help.									U	11/14/2006	11/15/2006	1		UNK	UNK	Blood pressue - Benicar Cholestrol - Prestore	none				1						1	Back pain; Headache; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0251832	12/22/2006		47.0	47		F	11/22/2006	Initial information received from Centers for Disease Control and Prevention on 14 November 2006. A 47 year old female patient received a dose of Adacel, lot number C2384AA, a dose of Fluzone SV2006-2005 USP, lot number U1763AA, and a dose of Twinrix (lot number AHABB079BA) on 05 December 2005. Concomitant medication included Rhinocort. 35 days post vaccination, on 11 January 2006, the patient developed asthenia, paresthesias, urinary incontinence, fecal incontinence, and decreased reflexes. She also had injection site inflammation at an unspecified injection site. The patient was admitted to the hospital on 13 January 2006 with acute inflammatory demyelinating polyneuropathy. A lumbar puncture showed albumino-cytologic dissociation. The patient was diagnosed with Guillain Barre Syndrome. No information was provided regarding treatment. The patient recovered from the events on 24 February 2006. The reporter of this case considered the events to be life threatening. Relevant Test/Laboratory Data: LP results showed albumino-cytologic dissociation.			Y				Y			12/06/2005	01/11/2006	36	LP results showed albumino-cytologic dissociation.	UNK	UNK	Rhinocort		The patient has a past medical history of depression.		200603088	1						2	Asthenia; CSF test abnormal; Demyelination; Guillain-Barre syndrome; Hyporeflexia; Inflammation; Laboratory test abnormal; Paraesthesia; Polyneuropathy; Guillain-Barre syndrome; Injection site inflammation; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U1763AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB029BA~UNK~IM~RA~HEP A + HEP B (TWINRIX)~1|TDAP~SANOFI PASTEUR~C2384AA~UNK~IM~LA~TDAP (ADACEL)~1|FLU3~SANOFI PASTEUR~U1763A~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB0298A~UNK~~~HEP A + HEP B (TWINRIX)~2|TDAP~SANOFI PASTEUR~C2384A~UNK~~~TDAP (ADACEL)~2	USA	Life Threatening,Hospitalisation	Influenza
0264138	12/22/2006	TX	81.0	81		F	12/08/2006	This case was reported by a pharmacist and described the occurrence of rash in a 81-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix) and pneumococcal vaccine for prophylaxis. The subject's medical history included sulfa allergy. Concurrent medications included Fluconazole (Diflucan) and Cephalexin. On 05 October 2006 at 10:49 am, the subject received a dose of Fluarix (0.5 ml, right arm). On 05 October 2006, the subject received 2nd dose of Pneumococcal vaccine (unknown). In the evening of 05 October 2006, the same day as vaccination with Fluarix and Pneumococcal vaccine, the subject experienced rash on her abdomen, under her breast, and under her neck. The subject was scheduled to see her physician on the day of reporting. At the time of reporting the event was unresolved. The pharmacist considered the event was possibility related to vaccination with Fluarix and Pneumococcal vaccine.				Y					N	10/05/2006	10/05/2006	0	UNK	OTH	OTH	Fluconazole Cephalexin	UNK	The subject has received influenza vaccine previously and did not experience and adverse reactions. The subject has not have any adverse reactions with previous vaccinee, including pneumococcal vaccine.		A0622831A	1						3	Pruritus; Rash; Pruritus; Rash; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA202BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0486F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA20281A~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~2|PPV~MERCK & CO. INC.~0486F~1~IM~LA~PNEUMO (PNEUMOVAX)~2|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA202BA~2~~UN~INFLUENZA (SEASONAL) (FLUARIX)~3|PPV~MERCK & CO. INC.~04868F~2~~UN~PNEUMO (PNEUMOVAX)~3	USA	Emergency room visit	Influenza
0269318	12/22/2006	NC	43.0	43		F	12/08/2006	This case was reported by a healthcare professional and described the occurrence of joint pain in a 43-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. Medical history included right hand dominant athletic. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. Concurrent medications included Oral contraceptive (Oral contraceptives). On 02 November 2006 the subject received a dose of Fluarix in the left deltoid. On 02 November 2006 less than one day after vaccination with Fluarix the subject experienced joint pain that felt as though the injection was given in the interarticular joint. The subject was seen by a physician and referred to an orthopedic specialist for physical therapy. The subject must work at home because of the pain. The healthcare provider considered the event was disabling. At the time of reporting, 28 November 2006, the event was worse.				Y				Y	U	11/02/2006	11/02/2006	0		OTH	OTH	oral contraceptive				A0629792A	1						2	Arthralgia; Joint range of motion decreased; Arthralgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA223AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA223AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Disabling	Influenza
0269509	12/22/2006		4.0			M		A report was received from a healthcare professional, via another manufacturer (Ref E2006-06328) on 15/Dec/2006, concerning a 4-year-old male vaccinee. No details were provided regarding the vaccinee's concomitant medications. At the time of vaccination the vaccinee had rhinitis and increased immunoglobulin E levels. The vaccinee has a history of immunology problems and fever following vaccination. On 18/Oct/2006, the vaccinee received an influenza vaccine (brand unspecified) in his right leg and Pneumovax 23 in his left leg, exact routes and locations unknown. On 18/Oct/2006, 12 hours after vaccination, the vaccinee developed left leg pain and fever. After 24 hours the pain increased and the vaccinee refused to walk. After 48 hours, the vaccinee was seen by the physician with leg redness, fever, generalized aches and pains and  tachycardia. The vaccinee was admitted to hospital for vaccine reaction, fever, possible bacteremia and diagnosed and was treated with antibiotics. It was reported that the  tachycardia may have been due to the fever. The vaccinee recovered from the generalized aches and pains in 1- 1 1/2 weeks and made a full recovery. The physician thought that maybe the reaction was an immune reaction to the vaccine as the vaccinee has had fever in the past following vaccinations. The reporter considers left leg pain, tachycardia and fever to be an important medical event (OMIC). No further information is expected.					Y	0				10/18/2006	10/18/2006	0		UNK	UNK	Concomitant drugs not reported.		At the time of vaccination the vaccinee had rhinitis and increased immunoglobulin E levels. The vaccinee has a history of immunology problems and fever after vaccination.		CVOX200600750	1						1	Abasia; Bacterial infection; Cellulitis; Immune system disorder; Injection site erythema; Injection site pain; Pain; Pyrexia; Tachycardia	FLUX~UNKNOWN MANUFACTURER~~UNK~~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1036P~UNK~~LL~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0269513	12/22/2006	MD	48.0	47		M	12/14/2006	Within 8 hours of vaccine developed fever, achiness, pain at site area, large blackened area with swelling and warmness at injection site and body aches all over. Saw primary medical doctor 12/8 and was given prescription for antibiotics.				Y					Y	11/29/2006	11/29/2006	0	complete blood count,  SMA 18 (all within normal limits)	PUB	PUB	NONE	NONE	NONE			1						1	Feeling hot; Injection site pain; Pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U2284AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269517	12/22/2006					F	11/28/2006	Fluarix dispensed and administered to newborn in error. Newborn should have received Engerix-B. Products look very similiar-especially when they are removed from outer packaging.													NONE	UNK	UNK			NONE (newborn)			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA222AA~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269518	12/22/2006			0	.0	M	11/28/2006	Fluarix dispensed and administered to newborn in error. Newborn should have received Engerix-B. Products look very similiar-especially when outer packaging is removed. Medication error.										10/07/2006			NONE	UNK	UNK			NONE			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA222AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVV316AB~UNK~IM~~HEP B (ENGERIX-B)~1	USA		Influenza
0269519	12/22/2006			0	.0	M	11/28/2006	Fluarix dispensed and administered to newborn in error. Newborn should have received Engerix-B. Products look very similar -especially when removed from outer packaging. Medication error										10/07/2006			NONE	UNK	UNK			None (newborn)			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFUL0222AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269520	12/22/2006		59.0			F	12/08/2006	This case was reported by a healthcare professional and described the occurrence of hive in a 59-year-old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. The subject's medical history included allergies and asthma. On an unspecified date before 22 August 2006, the subject received a dose of Influenza virus vaccine (lot number not provided). At an unspecified date on or before 22 August 2006, the subject experienced hive and swelling. The subject was seen at physician's office. At the time of initial reporting, 07 September 2006, the outcome of the events was not reported. Report received via manufacturer.				Y					U				UNK	OTH	OTH		UNK	ALLERGIES, ASTHMA The subject's concurrent conditions and concurrent medications were not reported.		A0619288A	1						1	Swelling; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0269521	12/22/2006	CA				U	12/08/2006	This case was reported by a healthcare professional to a sales representative and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date in 2006, on or before 03 October 2006, the subject received a dose of Fluarix (site of injection, dose number and lot number not provided). On an unspecified date in 2006, on or before 03 October 2006 less than one year after vaccination with Fluarix, the subject experienced injection site swelling the size of a baseball. At the time of initial reporting, 03 October 2006, the event was worse. The healthcare professional considered the event was probably related to vaccination with Fluarix.									U				UNK	OTH	OTH		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported. The nurse reported that two other subjects experienced adverse events following receipt of Fluarix. Please see cases A0622337A and A0622338A.		A0622331A	1						1	Injection site reaction; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269522	12/22/2006	CA	29.0	29		F	12/08/2006	This case was reported by a healthcare professional to a sales representative and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date in 2006, on or before 03 October 2006, on or before 03 October 2006 less than one year after vaccination with Fluarix, the subject experienced injection site swelling the subject experienced injection site swelling  the size of a baseball. At the time of initial reporting, 03 October 2006, the event was worse. The healthcare professional considered the event was probably related to vaccination with Fluarix. This is in follow-up to report(s) previously submitted on 12/08/2006. Follow-up received on 16 April 2007 via a healthcare professional. She reported that the 29 year old female subject was vaccinated with FLUARIX on 28 September 2006. Two hours after the vaccination, the subject experienced a raised, red rash on arms, chest and top of her feet. The rash was hot and itchy. She was diagnosed with a photosensitive rash. She was seen on 01 October 2006 and 02 October 2006 in occupational medicine at the hospital. She was treated with ATARX, hydrocortisone cream and methylprednisone. The reporter noted that the events were improved on 10October2006 and she considered that the events were related to the use of FLUARIX.				Y					N	09/28/2006	09/28/2006	0	UNK	PVT	OTH		Unknown	The subject's medical history, concurrent conditions, and concurrent medications were not reported. On follow-up it was reported that the subject had an amoxicillin reaction in 1990 and an allergic reaction to hospital soap. The nurse reported that two other subjects experienced adverse events following receipt of Fluarix. Please see cases A0622331A and A0622338A.		A0622337A	1						1	Injection site reaction; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA201AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0269523	12/22/2006	CA	45.0	45		F	12/08/2006	This case was reported by a healthcare professional to a sales representative and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date in 2006, on or before 03 October 2006, the subject received a dose of Fluarix (site of injection, dose number and lot number not provided). On an unspecified date in 2006, on or before 03 October 2006 less than one year after vaccination with Fluarix, the subject experienced a rash on hands and feet. At the time of initial reporting, 03 October 2006, the event was worse. The healthcare professional considered the event was probably related to vaccination with Fluarix. Follow-up received on 16 April 2007. The nurse reported that the 46-year old female received FLUARIX (intramuscular) on 29 September 2006 in her left arm. No other concurrent medications or vaccinations were received by the subject. Two days later, on 01 October 2006, the subject experienced a 3 inch x 2 and 1/2 inch red area on her left arm that was not painful and tender. She was seen by a physician. On 06 October 2006, the events resolved. The reported considered that the events were related to FLUARIX.									Y	09/26/2006	10/01/2006	5	UNK	PVT	OTH	No concurrent medication	Unknown	The subject's medical history, concurrent conditions, and concurrent medications were not reported. The nurse reported that two other subjects experienced adverse events following receipt of FLUARIX. Please see cases A0622331A and A0622337A.		A0622338A	1						1	Injection site erythema; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA201AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269525	12/22/2006	TX	65.0	65		F	12/08/2006	This case was reported by a consumer and described the occurrence of pain in a 65-year-old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. A physician or other health care professional has not verified this report. The subject's medical history allergy to ampicillin, allergy to Keflex, allergy to Lorabid, allergy to Percodan, bee sting allergy, bullous lung disease, Codeine allergy, lung surgery and tetracycline allergy. Concurrent medications included Esomeprazole (Nexium) and Combivent. The subject reported that she had received influenza virus vaccine in previous years with no subsequent adverse events. On 25 September 2006 at 12:30 p.m., the subject received a dose of Influenza virus vaccine in the right arm. That same evening, on 25 September 2006, at an unspecified time after vaccination with Influenza virus vaccine, the subject experienced arm pain which radiated to the neck. The subject was seen at the physician's office. The outcome of the event was not reported.				Y					U	09/25/2006	09/25/2006	0	UNK	OTH	OTH	Esomeprazole Combivent (Salbutamol sulphate + Ipratropium bromide)	UNK	ALLERGY TO AMPICILLIN, ALLERGY TO KEFLEX, ALLERGY TO LORABID, ALLERGY TO PERCODAN, BEE STING ALLERGY, BULLOUS LUNG DISEASE, CODEINE ALLERGY, LUNG SURGERY, TETRACYCLINE ALLERGY The subject's concurrent conditions were not reported.		A0622970A	1						1	Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0269526	12/22/2006					U	12/08/2006	This case was reported by a pharmacist via a representative and described the occurrence of rash in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The subject's medical history, concurrent conditions and concurrent medications were not reported. On 6 October 2006 the subject received unspecified dose of Fluarix intramuscularly in the right arm. The lot number and expiration date were not known. At an unspecified time after vaccination with Fluarix, the subject experienced rash on the right arm, face and chest. The subject also reported a stinging sensation. At the time of reporting the outcome of the events was unspecified. No additional information was available.									U	10/06/2006			UNK	OTH	OTH		UNK	The subject's medical history, concurrent conditions and concurrent medications were not reported.		A0623622A	1						1	Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA202BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269527	12/22/2006					F	12/08/2006	This case was reported by a physician, via a sales representative, and described the occurrence of exacerbation of asthma symptoms in a female patient who received Advair multi dose powder inhaler for chronic obstructive pulmonary disease and asthma. Co suspect medication included influenza virus vaccine (unspecified manufacturer). Concurrent medications included Solumedrol IV, prednisone and unspecified ABX. On an unknown date, the patient started fluticasone propionate+salmeterol xinafoate (inhaled), at an unknown dosing. At an unknown time after starting fluticasone propionate+salmeterol xinafoate, the patient experienced exacerbation of asthma symptoms, cough, congestion and wheezing. This case was assessed as medically serious by manufacturer (OMIC). Treatment with fluticasone propionate+salmeterol xinafoate was continued. At the time of reporting, the outcome of the events was unknown. The physician reported that while taking fluticasone propionate+salmeterol xinafoate, the patient's asthma symptoms of coughing, congestion, and wheezing became progressively worse. The patient received influenza vaccine (unspecified manufacturer) at the end of September 2006. At an unspecified time following receipt of influenza virus vaccine on an unspecified date on or after September 2006 and on or before 17 October 2006, the patients asthma symptoms worsened significantly. The physician discontinued fluticasone propionate+salmeterol xinafoate and continued all other medications as usual, and her asthma improved. Comment exacerbation of asthma symptoms was assessed as medically serious by manufacturer.									N					OTH	OTH	ME Prednisolone, Prednisone, Antibiotics		Asthma		A0624064A	1						1	Asthma; Condition aggravated; Cough; Nasal congestion; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0269528	12/22/2006	PA	55.0	55		F	12/08/2006	This case was reported by a consumer (also the health professional) and described the occurrence of itchy eyes in a 55-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. A physician or other health care professional has not verified this report. The subject has a history of latex allergy. No additional medical history was provided. The subject was not receiving and concurrent medications. On 19 October 2006 the subject, also the nurse, administered 50 Fluarix injections to subjects. The nurse has a medical history of latex allergy, so someone else removed the tip caps from each dose of Fluarix. After administering the injections, the nurse developed itchy eyes, a red face and cold symptoms, even though she did not touch the latex containing parts of the Fluarix. She had some improvement in symptoms by the following day. On follow-up the reporter stated that she also experienced stuffy nose and chest tightness.									N	10/19/2006	10/19/2006	0	UNK	OTH	OTH		UNK	The subject has a history of latex allergy. No additional medical history was provided. The subject was not receiving any concurrent medications.		A0624426A	1						1	Chest discomfort; Nasal congestion; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA219AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269529	12/22/2006	OH				U	12/08/2006	This case was reported by a pharmacist and described the occurrence of injection site hemorrhage in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On 23 October 2006 the subject received unspecified dose of Fluarix. The pharmacist reported that, on 23 October 2006, less than one day after vaccination with Fluarix, there was blood on the needle upon withdrawal from the subject. The pharmacist noted that the nurse who injected the Fluarix was not sure if Fluarix was injected intravenously or not. The outcome of the event was not reported. The pharmacist considered the event was probably related to vaccination with Fluarix.									U	10/23/2006	10/23/2006	0	UNK	OTH	OTH		UNK	The subject's medical history, concurrent conditions and concurrent medications were not reported.		A0624450A	1						1	Injection site haemorrhage	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269530	12/22/2006	TX				F	12/08/2006	This case was reported by a pharmacist and described the occurrence of medication errors in approximately 20 subjects and possibility 200 residents and employees at a long term care facility. Two of the subjects seen at the facility following the medication errors were female subjects of unspecified age who were vaccinated with influenza virus vaccine (Fluarix), for prophylaxis. This subject's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date the subject received Fluarix at 0.5 ml, subcutaneously in an unknown deltoid. This was considered to be a medication error, as the Fluarix should have been injected intramuscularly. At the unspecified time after vaccination with Fluarix, the subject experienced (1 1/2 in. diameter) area of swelling at the injection site, injection site pain, a black spot at injection site with redness around it. Tylenol was given for pain. At the time of reporting the outcome of the events was unspecified. The pharmacist considered the events were probably related to vaccination wit Fluarix.									U				UNK	OTH	OTH		UNK	The subject's medical history, concurrent conditions and concurrent medications were not reported.		A0624650A	1						1	Injection site erythema; Injection site pain; Injection site swelling; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA213AA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269531	12/22/2006	TX				F	12/08/2006	This case was reported by a pharmacist and described the occurrence of medication errors in approximately 20 subjects and possibly 200 residents and employees at a long term care facility. Two of the subjects seen at the facility following th medication errors were female subjects of unspecified age who were vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. This subject's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date the subject received Fluarix at 0.5 ml, subcutaneously in an unknown deltoid. This was considered to be a medication error, as the Fluarix should have been injected intramuscularly. At an unspecified time after vaccination with Fluarix, the subject experienced injection site pain and discomfort. Tylenol was given for pain. At the time of reporting the outcome of the events was unspecified. The pharmacist considered the events were probably related to vaccination with Fluarix.									U				UNK	OTH	OTH		UNK	The subject's medical history, concurrent conditions and concurrent medications were not reported.		A0624655A	1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA213AA~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269532	12/22/2006					U	12/08/2006	This case was reported by a pharmacist and described the occurrence of swelling of tongue in an adult subject of unspecified gender who was vaccinated with influenza vaccine (Fluarix) for prophylaxis. On an unspecified date in October  2006, on or before 26 October 2006, the subject received unspecified dose of Fluarix. On an unspecified date in October 2006, less than one month after vaccination with Fluarix, the subject experienced swelling of tongue and injection site irritation. The subject was seen at a physician's office. the subject was treated with oral diphenhydramine hydrochloride (Benadryl). At the time of initial reporting, 26 October 2006, the tongue swelling had resolved. The outcome of the injection site irritation was not reported.				Y					U				UNK	OTH	OTH		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported. The pharmacist reported that 5 other subjects experienced a swollen tongue and injection site irritation following receipt of Fluarix. Please see cases A0625102A, A0625103A, A0625104A, A0625105A, and A0625106A.		A0625099A	1						1	Injection site reaction; Skin irritation; Tongue oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0269533	12/22/2006					U	12/08/2006	This case was reported by a pharmacist and described the occurrence of swelling of tongue in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date in October 2006, on or before 26 October 2006, the subject received unspecified dose of Fluarix. On an unspecified date in October 2006, less than one month after vaccination with Fluarix, the subject experienced swelling of tongue and injection site irritation. The subject was seen at a physician's office. The subject was treated with oral diphenhydramine hydrochloride (Benadryl). At the time of initial reporting, 26 October 2006, the tongue swelling had resolved. The outcome of the injection site irritation was not reported.				Y					U	10/01/2006	10/01/2006	0	UNK	OTH	OTH		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported. The pharmacist reported that 5 other subjects experienced a swollen tongue and injection site irritation following receipt of Fluarix. Please see cases A0625099A, A0625103A, A0625104A, A0625105A, and A0625106A.		A0625102A	1						1	Injection site reaction; Skin irritation; Tongue oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0269534	12/22/2006					U	12/08/2006	This case was reported by a pharmacist and described the occurrence of swelling of tongue in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date in October 2006, on or before 26 October 2006, the subject received unspecified dose of Fluarix. On an unspecified date in October 2006, less than one month after vaccination with Fluarix, the subject experienced swelling of tongue and injection site irritation. The subject was seen at a physician's office. The subject was treated with oral diphenhydramine hydrochloride (Benadryl0. At the time of initial reporting, 26 October 2006, the tongue swelling had resolved. The outcome of the injection site irritation was not reported.				Y					U	10/01/2006	10/01/2006	0	UNK	OTH	OTH		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported. The pharmacist reported that 5 other subjects experienced a swollen tongue and injection site irritation following receipt of Fluarix. Please see cases A0625099A, A0625102A, A0625104A, A0625105A, and A0625106A.		A0625103A	1						1	Injection site reaction; Skin irritation; Tongue oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0269535	12/22/2006					U	12/08/2006	This case was reported by a pharmacist and described the occurrence of swelling of tongue in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date in October 2006, on or before 26 October 2006, the subject received unspecified dose of Fluarix. On an unspecified date in October 2006, less than one month after vaccination with Fluarix, the subject experienced swelling of tongue and injection site irritation. The subject was seem at a physician office. The subject was treated with oral diphenhydramine hydrochloride (Benadryl). At the time of initial reporting, 26 October 2006, the tongue swelling had resolved. The outcome of the injection site irritation was not reported.				Y					U	10/01/2006	10/01/2006	0	UNK	OTH	OTH		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported. The pharmacist reported that 5 other subjects experienced a swollen tongue and injection site irritation following receipt of Fluarix. Please see cases A0625099A, A0625102A , A0625103A, A0625105A, and A0625106A.		A0625104A	1						1	Injection site reaction; Skin irritation; Tongue oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0269536	12/22/2006					U	12/08/2006	This case was reported by a pharmacist and described the occurrence of swelling of tongue in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date in October 2006, on or before 26 October 2006, the subject received unspecified dose of Fluarix. On an unspecified date in October 2006, less than one month after vaccination with Fluarix, the subject experienced swelling of tongue and injection site irritation. The subject was seen at a physician's office. The subject was treated with oral diphenhydramine hydrochloride (Benadryl). At the time of initial reporting, 26 October 2006, the tongue swelling had resolved.				Y					U	10/01/2006	10/01/2006	0	UNK	OTH	OTH		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported. The pharmacist reported that 5 other subjects experienced a swollen tongue and injection site irritation following receipt of Fluarix. Please see cases A0625099A, A0625102A, A0625103A, A0625104A, and A0625106A.		A0625105A	1						1	Injection site reaction; Skin irritation; Tongue oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0269537	12/22/2006					U	12/08/2006	This case was reported by a pharmacist and described the occurrence of swelling of tongue in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date in October 2006, on or before 26 October 2006, the subject received unspecified dose of Fluarix. On an unspecified date in October 2006, less than one month after vaccination with Fluarix, the subject experienced swelling of tongue and injection site irritation. The subject was seen at a physician's office. The subject was treated with oral diphenhydramine hydrochloride (Benadryl). At the time of initial reporting, 26 October 2006, the tongue swelling had resolved. The outcome of the injection site irritation was not reported.				Y					U	10/01/2006	10/01/2006	0	UNK	OTH	OTH		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported. The pharmacist reported that 5 other subjects experienced a swollen tongue and injection site irritation following receipt of Fluarix. Please see cases A0625099A, A0625102A, A0625103A, A0625104A, and A0625105A.		A0625106A	1						1	Injection site reaction; Skin irritation; Tongue oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0269538	12/22/2006	NC	23.0			F	12/08/2006	This case was reported by a healthcare professional and described the occurrence of injection site soreness in a 23-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The subject had experienced soreness in the arm without any rash following receipt of prior immunizations of influenza virus vaccine. On 26 October 2006 the subject received a dose of Fluarix in the left arm. On 27 October 2006, 1 day after vaccination with Fluarix, the subject experienced injection site soreness, a rash in a ring around the injection site, and body aches. The outcome of the events was not reported. The healthcare professional considered the events were probably related to vaccination with Fluarix. Follow-up received on 10 November 2006 indicated that on 28 October 2006 the subject was evaluated on 28 October 2006 to rule out underlying pain issues. The reporter stated that the subject experienced a halo type rash around the site of injection,a arm pain and generalized body aches. The subject was in no distress and denied any difficulty breathing, swallowing, fever or swelling. At the time of this report, the healthcare professional considered the events were possibly related to vaccination with Fluarix.									U	10/26/2006	10/27/2006	1	UNK	OTH	OTH		UNK	The subject had no pre-existing medical conditions. The subject's concurrent conditions and concurrent medications were not reported.	Soreness in the arm~Influenza (Seasonal) (no brand name)~~0.00~In Patient	A0625455A	1						1	Injection site rash; Injection site reaction; Myalgia; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA221AA~1~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269539	12/22/2006	CO	72.0			M	12/08/2006	This case was reported by a healthcare professional and described the occurrence of rash in a 72-year-old male subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. Medical history included no allergies (no egg allergy). There were no concurrent mediations. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On 27 October 2006 the subject received a dose of Fluarix in the left arm. On 27 October 2006, 8 hours after vaccination with Fluarix, the subject experienced redness and rash primarily on the trunk, arms, and legs accompanied with severe itching. The subject was seen at a physician's office on 30 October 2006. Hematological analyses from 30 October 2006 revealed a normal sedimentation rate and complete blood count. At the time of initial reporting, 30 October 2006, the itching had improved and the redness and rash were ongoing. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/27/2006	10/27/2006	0	CBC 30Oct2006 Normal Erythrocyte sedimentation rate 30Oct2006 Normal	MIL	MIL	No concurrent medication	UNK	Medical history included no allergies (no egg allergy). The subject's concurrent conditions were not reported.		A0625457A	1						1	Erythema; Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA222AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0269540	12/22/2006	CO	28.0	28		F	12/08/2006	A pharmacist prospectively reported the occurrence of burning sensation (rash) in a pregnant female subject of unspecified age who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The subject's date of last menstrual period, estimated due date, or weeks of gestation at time of vaccination were not reported. On 31 October 2006 the subject received an unspecified dose of Fluarix during an unspecified trimester of pregnancy. On or after 31 October 2006 and on or before 06 November 2006, less than one week after vaccination with Fluarix, the subject experienced a rash on both of her thighs. The pharmacist reported that , the rash was not itchy, but it did burn. The subject was treated with diphenhydramine hydrochloride (Benadryl). At the time of initial reporting, 06 November 2006, the rash had improved. The pharmacist considered the rash to possibly be related to vaccination with Fluarix. Follow-up information received on 21 November 2006 indicated that the subject was 28 years old. Her last menstrual period was on 28 August 2006. The event began on 01 November 2006 and was resolved by 06 November 2006. In the reporter's opinion, the event was considered to be related to treatment with Fluarix.									Y	10/31/2006	11/01/2006	1	UNK	OTH	OTH		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported.		A0626413A	1						1	Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA201BA~UNK~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269541	12/22/2006	OH	75.0			F	12/08/2006	This case was reported by a pharmacist and described the occurrence of arm pain in a 75 year old female subject who was vaccinated with Fluarix for prophylaxis. The subject's medical history included high blood pressure. Concurrent medications included blood pressure medication. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On 11 October 2006 the subject received unspecified dose of Fluarix in the left arm. On 11 October 2006, less than one day after vaccination with Fluarix, the subject experienced arm pain when she elevates her arm over her head and injection site tenderness. At the time of initial reporting, 07 November 2006, the events were worse.										10/11/2006	10/11/2006	0	UNK	UNK	PVT	blood pressure medication	UNK	The subject's concurrent conditions were not reported.		A0626427A	1						1	Injection site pain; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA202A~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269542	12/22/2006	IL	35.0			F	12/08/2006	This case was reported by a pharmacist and described the occurrence of injection site cellulitis in a 35-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix), plus a separate injection of 23-valent pneumococcal polysaccharide vaccine (Pneumovax) for prophylaxis. Medical history included cellulitis following prior receipt of concomitant administration of influenza virus vaccine and Pneumovax and sickle cell anemia. The subject received multiple unspecified concurrent medications. On 30 October 2006 at 9:00 a.m., the subject received a dose of Fluarix in the right thigh. On 30 October 2006 the subject also received a dose of Pneumovax at an unspecified site of injection. At the time of the concomitant administration of Fluarix and Pneumovax, 30 October 2006, the subject was hospitalized for sickle cell anemia. On 31 October 2006, 1 day after vaccination with Fluarix and Pneumovax, the subject experienced injection site cellulitis. The reporter did not specify at which site of injection the cellulitis occurred. The subject's hospitalization was extended as a result of the injection site cellulitis and the pharmacist considered the event was disabling and clinically significant (or requiring intervention) (OMIC). The subject was treated with intravenous and oral clindamycin. At the time of initial reporting, 07 November 2006, the injection site cellulitis was ongoing. The pharmacist reported that she does not know if the injection site cellulitis is due to the Fluarix or the Pneumovax.					Y			Y	N	10/30/2006	10/31/2006	1		OTH	OTH	UNK		SICKLE CELL ANEMIA, The subject's concurrent conditions were not reported.		A0626767A	1						1	Cellulitis; Injection site reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation,Disabling	Influenza
0269543	12/22/2006	FL	52.0	51		F	12/08/2006	This case was reported by a healthcare professional and described the occurrence of injection site redness in a 51 year old female subject who was vaccinated with Fluarix for prophylaxis. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On 07 November 2006, the subject received a dose of Fluarix in the right arm. On 07 November 2006, less than one day after vaccination with Fluarix, the subject experienced an injection site reaction described as a 5.5 by 5.5cm circular pattern, 0.5 inch raised bump that was red, warm and painful. The subject was seen at an emergency room. The outcome of the events was not reported. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					U	11/07/2006	11/07/2006	0	UNK	PVT	PVT		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported. The healthcare professional reported that one other subject experienced an injection site reaction following receipt of Fluarix from lot AFLUA201BA. Please see case A0627081A.		A0627078A	1						1	Feeling hot; Injection site erythema; Injection site pain; Injection site reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLuA201BA~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0269544	12/22/2006	FL	33.0			F	12/08/2006	This case was reported by a healthcare professional and described the occurrence of injection site redness a 33 year old female subject who was vaccinated with Fluarix for prophylaxis. On 06 November 2006 the subject received a dose of Fluarix in the left arm. On 06 November 2006, less than one day after vaccination with Fluarix, the subject experienced an injection site reaction described as  a 5.5 by 5.5 cm circular pattern, 0.5 inch raised bump that was red, warm and painful. The subject was seen at an emergency room. The outcome of the events was not reported. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					U	11/06/2006	11/06/2006	0	UNK	PVT	PVT		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported. The healthcare professional reported that one other subject experienced an injection site reaction following receipt of Fluarix from lot AFLUA201BA. Please see case A062707BA.		A0627081A	1						1	Feeling hot; Injection site erythema; Injection site pain; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA201BA~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0269545	12/22/2006	NY	48.0			F	12/08/2006	This case was reported by a healthcare professional via a sales representative and described the occurrence of injection site rash in a subject of unspecified age and gender who was vaccinated with Fluarix for prophylaxis. The subject has previous problems with the flu vaccine. It was unknown what type of problems the subject experienced or to which flu vaccine. In November 2006 the subject received an unspecified dose of Fluarix (.5 ml, unknown). In November 2006, at an unspecified time after vaccination with Fluarix, the subject experienced injection site rash and shortness of breath. The subject was seen in the emergency department. The sales representative believed that Fluarix was administered one to two days ago. He did not know if the subject was hospitalized as a result of the events was unspecified. Follow up was received from the reporting healthcare professional on 29 November 2006. The subject is a 48 year old female. On an unspecified date in November 2006, the subject received a dose of Fluarix. Approximately one to two hours later, the subject experienced injection site rash and shortness of breath. The subject was seen in an emergency department, but was not admitted to the hospital. The events resolved on an unspecified date in November 2006. The healthcare professional considered the events to possibly be related to vaccination to Fluarix and also to the preservative in Fluarix.				Y					Y				UNK	PVT	PVT		UNK	Non smoker, non drinker		A0627105A	1						1	Dyspnoea; Injection site rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA205AA~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0269546	12/22/2006					U	12/08/2006	This case was reported by a pharmacist and described the occurrence of muscle soreness in a subject of unspecified age and gender following vaccination with Fluarix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On or before 10 November 2006, the subject was vaccinated with Fluarix. At an unspecified time after vaccination with Fluarix, the subject experienced extreme muscle soreness that lasted four days or more with swelling from the shoulder to the elbow. Further information was unknown.									U				UNK	OTH	OTH		UNK	The subject's past medical conditions, concurrent conditions and concurrent medications were not specified. The reporter stated that this occurred in three subjects. The numbers are A0627329A, A062745A and A0627346A.		A0627329A	1						1	Myalgia; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269547	12/22/2006					U	12/08/2006	This case was reported by a pharmacist and described the occurrence of muscle soreness in a subject of unspecified age and gender following vaccination with Fluarix virus vaccine for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On or before 10 November 2006, the subject was vaccinated with Fluarix. At an unspecified time after vaccination with Fluarix, the subject experienced extreme muscle soreness that lasted four days or more with swelling from the shoulder to the elbow. Further information was unknown.									U				UNK	OTH	OTH		UNK	The subject's past medical conditions, concurrent conditions and concurrent medications were not specified. The reporter stated that this occurred in three subjects. The numbers are A0627329A, A0627345A, and A0627346A.		A0627345A	1						1	Myalgia; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269548	12/22/2006					U	12/08/2006	This case was reported by a pharmacist and described the occurrence of muscle soreness in a subject of unspecified age and gender following vaccination with Flurarix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On or before 10 November 2006, the subject was vaccinated with Fluarix. At an unspecified time after vaccination with Fluarix, the subject experienced extreme muscle soreness that lasted four days or more with swelling from the shoulder to the elbow. Further information was unknown.									U				UNK	OTH	OTH		UNK	The subject's past medical conditions, concurrent conditions and concurrent medications were not specified. The reporter stated that this occurred in three subjects. The numbers are A0627329A, A0627345A, and A0627346A.		A0627346A	1						1	Myalgia; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269549	12/22/2006	NC	47.0	47		F	12/08/2006	This case was reported by a consumer and described the occurrence of heartburn in a 47 year old female subject who was vaccinated with Fluarix for prophylaxis. The reporter is the subject. A physician or other health care professional has not verified this report. The subject's medical history included high cholesterol, osteoporosis, and occasional heartburn after eating a large meal. Co suspect medication included Boniva (PO 02 Nov 2006) for osteoporosis. Concurrent medications included multivitamin, aspirin, Calcium and fish oil. On 02 November 2006, the subject received her first dose of oral Boniva. Approximately two days later, on 04 November 2006, the subject experienced chest pressure. On 06 November 2006, the subject received a dose of Fluarix. On 06 November 2006, less than one day after vaccination with Fluarix and four days after the receipt of Boniva, the subject experienced heartburn and extreme chest pain. The subject treated the events with antacid. The heartburn and chest pain improved approximately three hours later. Therapy with Boniva was continued. At the time of initial reporting, 10 November 2006, the subject reported that she has not had another episode of heartburn with pain, but every time she eats, she feels like food just sits on her chest and she has a dull ache between her breasts.									N	11/06/2006	11/06/2006	0	UNK	OTH	PVT	Multivitamin, Aspirin, Calcium salt, fish oil, aspirin	UNK	High cholesterol, occasional GI distress after meal, osteoporosis. Medical history included occasional heartburn after eating a large meal. The subject's concurrent conditions were not reported.		A0627360A	1						1	Chest discomfort; Chest pain; Dyspepsia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269550	12/22/2006	MI	8.0			M	12/08/2006	This case was reported by a physician and described the occurrence of arm soreness in a 8 year old male subject who was inadvertently vaccinated with Fluarix for prophylaxis. Previous history of arm soreness with other influenza vaccinations. On 07 November 2006 the subject received Fluarix .5 ml and experienced a sore arm and inadvertently vaccination with Fluarix. Fluarix is recommended for immunizing individuals 18 years and older. Further information was not known.									U	11/07/2006	11/07/2006	0	UNK	PVT	PVT		UNK	The subject's past medical history included arm soreness with other influenza vaccinations. Concurrent conditions and concurrent medications were not specified.		A0627463A	1						1	Medication error; Myalgia; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269551	12/22/2006	IL				U	12/08/2006	This case was reported by a pharmacist and described the occurrence of allergic reaction in a subject of unspecified age and gender who was vaccinated with Fluarix for prophylaxis. The subject's medical history included allergy to antibiotic. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On an unspecified date in 2006, on or before 14 November 2006, the subject received unspecified dose of Fluarix. On an unspecified date in 2006, on or before 14 November 2006, less than one year after vaccination with Fluarix the subject experienced allergic reaction and hive. The subject was seen in an emergency room. The outcome of the events was not reported.				Y									UNK	OTH	OTH		UNK	Allergy to antibiotic. The subject's concurrent conditions and concurrent medications were not reported. The pharmacist reported that three other subjects experienced an allergic reaction following receipt of Fluarix. Please see cases A0627714A, A0627715A, and A0627716A.		A0627713A	1						1	Hypersensitivity; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0269552	12/22/2006	IL				U	12/08/2006	This case was reported by a pharmacist and describe the occurrence of allergic reaction in a subject of unspecified age and gender who was vaccinated with Fluarix for prophylaxis. The subject's medical history included allergy to antibiotic. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On an unspecified date in 2006, on or before 14 November 2006, the subject received unspecified dose of Fluarix. On an unspecified date in 2006, on or before 14 November 2006, less than one year after vaccination with Fluarix, the subject experienced allergic reaction and hive. The subject was seen in an emergency room. The outcome of the events was not reported.				Y					U				UNK	OTH	OTH		UNK	Allergy to antibiotic. The subject's concurrent conditions and concurrent medications were not reported. The pharmacist reported that three other subjects experienced an allergic reaction following receipt of Fluarix. Please see cases A0627713A, A0627715A, and A0627716A.		A0627714A	1						1	Hypersensitivity; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0269553	12/22/2006	IL				U	12/08/2006	This case was reported by a pharmacist and described the occurrence of allergic reaction in a subject of unspecified age and gender who was vaccinated with Fluarix for prophylaxis. The subject's medical history included allergy to antibiotic and allergy to penicillin. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On an unspecified date in 2006, on or before 14 November 2006, the subject received unspecified dose of Fluarix. On an unspecified date in 2006, on or before 14 November 2006, less than one year after the vaccination with Fluarix, the subject experienced allergic reaction and hive. The subject was seen in an emergency room. The outcome of the events was not reported.				Y					U				UNK	OTH	OTH		UNK	Allergy to antibiotic, penicillin allergy. The subject's concurrent conditions and concurrent medications were not reported. The pharmacist reported that three other subjects experienced an allergic reaction following receipt of Fluarix. Please see cases A0627713A, A0627714A, and A0627716A.		A0627715A	1						1	Hypersensitivity; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0269554	12/22/2006	IL	24.0	23		M	12/08/2006	This case was reported by a pharmacist and described the occurrence of allergic reaction in a 23 year old male subject who was vaccinated with Fluarix for prophylaxis. The subject's medical history included allergy to antibiotic and allergy to pencilling. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On 18 October 2006, the subject received unspecified dose of Fluarix. On 19 October 2006, one day after vaccination with Fluarix, the subject experienced allergic reaction and hive. The subject was seen in an emergency room and was treated with Benadryl. The events resolved on an unspecified date. On 20 November 2006, the subject again experienced hives. The outcome of the second episode of hives was not reported. The pharmacist considered the events to not be related to vaccination with Fluarix.				Y					U	10/18/2006	10/19/2006	1	UNK	PVT	PVT	No concurrent medication	UNK	Allergy to antibiotic, penicillin allergy. The subject's concurrent conditions were not reported. The pharmacist reported that three other subjects experienced an allergic reaction following receipt of Fluarix. Please see cases A0627713A, A0627714A, and A0627715A.		A0627716A	1						1	Hypersensitivity; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA213BA~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0269555	12/22/2006	MT	50.0	50		M	12/08/2006	This case was reported by a pharmacist and described the occurrence of chills in a male subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 1 November 2006 the subject received 1st dose of FLUARIX at 0.5 ml. On 2 November 2006, in the morning, the subject experienced chills, vomiting, fever up to 104 degrees and diarrhea. The events were improved by 5 November 2006.  Follow-up infromation was receivved on 30 December 2006. The subject's concurrent conditions included tobacco use of 1/2 pack per day. The subject was 50 years of age at the time of the events. The events resolved on 05 November 2006. The reporter copnsidered that the events were not related to vaccination with FLUARIX.									Y	11/01/2006	11/02/2006	1	UNK	OTH	OTH		Tobacco use	Tobacco use 1/2 pack per day. No alcohol use		A0628030A	1						1	Chills; Diarrhoea; Pyrexia; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA201EA~1~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269556	12/22/2006	PA	32.0	32		F	12/08/2006	This case was reported by a healthcare professional and described the occurrence of allergic reaction in a 32 year old female subject who was vaccinated with Fluarix for prophylaxis. The reporter is the subject. The subject's medical history included allergy to gentamycin, allergy to phenergan, penicillin allergy, rocephin allergy, sulfa allergy and vancomycin allergy. The subject reported that she is not allergic to latex. There were no concurrent medications. The subject had received influenza virus vaccine in previous years and had experienced the flu. On 13 November 2006 the subject received unspecified dose of Fluarix in the left arm. On 13 November 2006, 2 hours after vaccination with Fluarix, the subject experienced an allergic reaction described as rash, itching and erythema on the lower body extremities and hives. That evening, on 13 November 2006, the subject experienced flu like symptoms, aches, and head and spine pain. The subject was seen by a physician. The subject was treated with Benadryl. At the time of initial reporting, 22 November 2006, the events were improved. The vaccination course with Fluarix was discontinued. Follow-up received on 03 January 2007 from the healthcare professional (who is also the subject) noted that she considered the events to be related to the use of Fluarix because it contains gentamicin.				Y					N	11/13/2006	11/13/2006	0	UNK	PUB	OTH	No concurrent medication	UNK	Allergy to Gentamycin, Phenergan, Penicillin, Rocephin, Sulfa, Vancomycin		A0628735A	1						1	Erythema; Influenza like illness; Pain; Pruritus; Rash; Reaction to preservatives; Urticaria; Urticaria; Vaccination complication	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0269557	12/22/2006	NC	70.0	70		F	03/21/2007	This case was reported by a healthcare professional and described the occurrence of injection site inflammation in a 70 year old female subject who was vaccinated with Fluarix for prophylaxis. The subject's medical history included femoral venous bypass graft, lichen nitidus, ovarian cancer and rheumatoid arthritis. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. Concurrent medications include Extra strength Tylenol, Tiazac, Diavan, Synthroid, Nexium, Plavix. On 07 November 2006 the subject received a dose of Fluarix in the left deltoid. On 07 November 2006, less than one day after vaccination with Fluarix, the subject experienced injection site inflammation and a lump injection site. On an unspecified date after 07 November 2006 and on or before 28 November 2006, the subject experienced injection site rash and injections site papule. The subject did not have pain or itching at the injection site. The subject was seen at a physician's office. At the time of initial reporting, 28 November 2006, the events were ongoing.  Follow-up was received from the healthcare professional on 11 December 2006.  The events had improved on 07 December 2006.  The healthcare professional considered the events to be related to vaccination with FLUARIX.				Y					N	11/07/2006	11/07/2006	0	UNK	OTH	PVT	Paracetamol, Diltiazem hydrochloride, Diavan, Thyroxine sodium, Esomeprazole, clopidogrel bisulphate.	UNK	Femoral venous bypass graft, lichen nitidus, ovarian cancer, rheumatoid arthritis. The healthcare professional reported that one other subject experienced adverse events following reciept of Fluarix from lot AFLUA223AA. Please see case A0629792A.	This vaccinee had no adverse events following receipt of prior immunizations of influenza virus vaccine.~ ()~~0.00~Patient	A0629795A	1						1	Injection site inflammation; Injection site mass; Injection site nodule; Injection site rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA223AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0269558	12/22/2006	OK	63.0	63		F	12/08/2006	This case was reported by a healthcare professional and described the occurrence of swelling at the injection site in a 63 year old female subject who was vaccinated with FLUARIX, (GlaxoSmithKline). Concurrent medications included MVI, Tylenol, Cenestin, Diovan, Felodipine, Synthroid, Nexium, Hydrochlorothiazide, Anacin, Requip, Enablex and Lipitor.  Medical history included non-smoker, non-drinker, sleep problems, estrogen therapy, hypertension, thyroid disorder, gastric disorder, fluid retention, headache, parkinsinonism, spasms, and elevated cholesterol.  On 13 November 2006 the subject received 1st dose of FLUARIX at 0.5 ml, intramuscularly in the right deltoid. On 20 November 2006, 7 days after vaccination with FLUARIX, the subject experienced swelling at the injection site and injection site redness. At the time of follow-up reporting, 11 December 2006, the events had imorpved and the healthcare professional reported that, the swelling has decreased but remains slightly pink.									Y	11/13/2006	11/20/2006	7	UNK	OTH	PVT	MVI (Vitamin K + Potassium salt + Vitamin E + Retinol + Dexpanthenol + Pantothenic acid + Ascorbic acid + Pyridoxine hydrochloride + Niacinamide + Nicotinic acid + Thiamine hydrochloride + Riboflavine + Vitamin D + Biotin + Folic acid + Cya	Unknown	Elevated cholesterol level; Fluid retention; Gastric disorder; Headache; Hormonal supplement; Hypertension; Non-Drinker; Nonsmoker; Parkinsonism; Sleeping aid; Spasm; Thyroid disorder		A0630094A	1						1	Injection site erythema; Injection site erythema; Injection site swelling; Skin discolouration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU216AA~1~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269559	12/22/2006	FL				M	12/08/2006	This case was reported by a nurse practitioner and described the occurrence of unspecified adverse reaction in a male subject of unspecified age who was vaccinated with Fluarix for prophylaxis. On an unspecified date in November 2006, the subject received unspecified dose of Fluarix (unknown). On an unspecified date, in November 2006, but prior to 28 November 2006, after vaccination with Fluarix, the subject experienced unspecified adverse reaction. At the time of reporting, the nurse practitioner stated the subject received the Fluarix approximately one month ago and was complaining of several adverse events (unspecified). The nurse practitioner was to see the subject the next day and was to call back with further details of the adverse events. At the time of reporting the outcome of the event was unspecified.									U	11/01/2006			UNK	OTH	OTH		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported.		A0630109A	1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269560	12/22/2006	MT	39.0	39		M	03/21/2007	This case was reported by a pharmacist and described the occurrence of joint pain in adult male subject who was vaccinated with Fluarix for prophylaxis. On 02 November 2006 the subject received unspecified dose of Fluarix. On 04 November 2006, 2 days after vaccination with Fluarix, the subject experienced joint pain, muscle pain, painful skin, respiratory congestion, fever, headache and chest pain. The events were ongoing as of 15 November 2006, but the pharmacist was unsure if the events persisted at the time of initial reporting, 30 November 2006.  Follow-up information received on 02 January 2007 indicated that the events were improved and in the reporter's opinion, the events were not related to treatment with FLUARIX.									N	11/02/2006	11/04/2006	2	UNK	PUB	PUB		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported.  The subject only uses alcohol occasionally and uses smokeless tobacco (1 can/2 weeks)		A0630281A	1						1	Arthralgia; Chest pain; Headache; Myalgia; Pain; Pyrexia; Respiratory tract congestion	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA201BA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269564	12/22/2006	NH	9.0	9		M	12/22/2006	Severe Muscle weakness developed within 12 hours.  Lack of appetite, very lethargic, high grade fever (103.8, taken in ear) present 20 hours after administration of shot.  On recommendation from nurse at clinic, Subject given aspirin and fever was reduced through out the night.  31 hours after vaccine, Subject's temp was close to normal.									Y	12/20/2006	12/21/2006	1		UNK	UNK	Subject takes 10mg Fluoxetine HCL/ day to manage anxiety related to Aspergers	Showed signs of cold onset, however symptoms had gone away by 12/21/06 (day after vaccine)	Subject has high functioning Aspergers.  He is very healthy, gets maybe one or two  colds per year (usually very short lasting).			1						1	Anorexia; Lethargy; Muscular weakness; Pyrexia	FLU3~SANOFI PASTEUR~UT2175BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269565	12/22/2006	MN	41.0	41		M	12/22/2006	Pt received MMR and influenza shots at approx. 7AM, then reported to work as LPN at medical center.  At approx. 11AM he experienced sudden onset of a burning sensation in his mouth and throat and shortness of breath.  He was on his way to the ED when he experienced diaphoresis.  A medical alert was called and he was given epinephrine 0.3 mg SQ.  He was awake and alert, but complaining of difficulty breathing when the ED physician arrived on the scene.  He was tranported to the ED where he received Benadryl 50 mg IV and SoluMedrol 125 mg IV.  He was observed for 3 hours before being discharged to home.				Y					Y	11/01/2006	11/01/2006	0	In ED - BP 130/78, temp 98.7, O2 sats 99% on room air.	UNK	UNK	multivitamin 1 PO daily Vitamin C PO daily	None	h/o anaphylactic rxn to shrimp			1						1	Burning sensation mucosal; Dyspnoea; Hyperhidrosis; Oral pain; Pharyngolaryngeal pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71826~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|MMR~MERCK & CO. INC.~0378R~UNK~IM~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0269568	12/22/2006	TX	55.0	54		M	12/13/2006	12-7-06 Patient flu shot pain began in right elbow one or two hours after receiving flu vaccine. Patient reports the joint was sensitive to touch and a sharp pain upon movement. Patient reports that the next day 12-8-06 the same pain moved to his left ankle then to the upper part of the Left side of his neck. He reports the pain more severe in this area. Next the pain moved to his Right knee he felt he could not straighten his leg. Patient reports pain then moved to his Left hand between his index and second fingers then to back of neck and it is (12-13-06) in his Left shoulder area. Patient reports pain now as not bad with a dull pain when he raises his arm. Patient reports he went to his family physician on 12-11-06 where he was given a steroid shot that seems to have helped. At that visit to his physician the patient reports that lab work to rule out side effects of the Lipitor he takes was drawn and found to be negative. A flu test was performed and came back positive for flu. Patient reports not having experienced an adverse event with any flu shots in the future.				Y					Y	12/07/2006	12/07/2006	0	lab testing performed by patients physician to rule out complications with Lipitor. Lipitor not the problem. Patient had a positive flu rapid test the day he went to medical doctor on 12-11-06.	PVT	PVT	Plavix, Topril, Zetia, Lipitor, Protonix, Acifix, aspirin	NONE	Stent placed in heart in 2004.			1						1	Arthralgia; Influenza; Laboratory test abnormal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71822~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0269569	12/22/2006	NY	80.0	80		M	12/11/2006	Patient received vaccine in late afternoon. Wife stated patient awoke next am with extreme lethargy, unable to dress/feed himself, began having mild trembling. Trembling has ceased, remains lethargic and unable to dress/feed self. Wife reported condition to physician, who agreed pt was more lethargic.									N	11/14/2006	11/15/2006	1	NONE	PUB	PUB	Digitek, Kitorin, Dilantin.	Mini stroke 01/2006	CVZ 2002 Speech affected.			1						1	Hypokinesia; Lethargy; Tremor	FLU3~SANOFI PASTEUR~A237AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269597	12/22/2006	MN	59.0	59		F	12/22/2006	Received vaccination at work in a Hospital at approximately 9am on Monday, November 6, 2006 in my right upper arm.  Awakened at 3:30am the next morning, Tuesday, November 7, 2006 with severe tingling and numbness in BOTH hands.  I am left handed.  I have had NO history of numbness or tingling in either arm.  Was concerned about possible stroke or MI symptoms.  Took B/P at home and it registered 188/110.  Took 2 ASA and rechecked B/P several times.  Numbness and tingling and swelling in both hands did not subside.  Went to hospital OR (where I am employed) and rechecked by B/P there.  It was still 180/98.  Numbness and tingling persisted, so I presented at  Emergency Room and was seen by MD.  I was especially concerned about the left hand numbness as it was my dominant hand.  I have never had ANY problems with prior symptoms such as these before.  He examined me, drew lab work, and monitored my elevated B/P.  The digits involved in my hands were thumbs, index fingers, middle fingers, and the inner aspect of the ring fingers.  He diagnosed the problem as carpal tunnel and I was discharged with a left arm splint as this was my dominant hand.  I reported these symptoms to EOHS on Thursday morning, Novmeber 9th to see if any other prior reactions had been reported.  She called MD and there had been some report of Carpal Tunnel in the immunized side, but none bilaterally.  I, at no time, lost no time at work throughout this ordeal.  There was a time lapse between the immunization reporting and this document, because I had a conference for 10 days, then the day I returned, my Mother died and I had another week off for funeral arrangements and support for my Father.  I only mention this to explain the time lapses and delays between the occurrence and consultation with physicians.  The symptoms continued and still are present.  I tried Ibuprofin, but it provided no relief.  My internist at a Clinic was unavailable and I saw his colleague on Friday, December 8th @ 3:20pm (the soonest appointment available).  He confirmed the diagnosis of bilateral carpal tunnel and said I didn't need an EMG as the diagnosis was definitive to him.  They set up an appointment with a Hand Surgeon on Wednesday, December 27th @ 3:30pm which was the soonest I could see him also.  I await the visit and remedy and have seen the EOHS nurses several times for consultation.  I continue to wear bilateral hand splints and this seems to help some of the numbness, but it is still VERY present in the same 4 1/2 digits on both hands.  An employee incident was completed as requested by EOHS on December 6, 2006.  Note that I am due for my second dose of Rubella vaccine for employment, but it is suggested that I defer than until after this situation is resolved.				Y					U	11/06/2006	11/07/2006	1	Lab work was done At Hospital Emergency Room on Tuesday, Novmeber 7, 2006 and the results were reportedly negative for the tests done.	MIL	OTH	Maxide 1 daily	None	Allergy to Augmentin			1						1	Blood pressure increased; Carpal tunnel syndrome; Hypoaesthesia; Oedema peripheral; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA221BA~7+~SC~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0269598	12/22/2006	MN	32.0	32		F	12/22/2006	Pt was hospitalized 1/12/06 for uncomplicated childbirth.  Prior to discharge on 1/14/06, she was given influenza vaccine, pneumococcal vaccine (due to h/o splenectomy), and Depo Provera.  It appears all vaccines were given in right buttock.  Later that day, she developed general malaise, then sweats and chills.  Her temperature that evening was 102.  She presented to the ED on 1/15/06 with fever (100.4), sweats, and chills.  Exam revealed an area of 8-10 cm expanding erythema with induration at her injection site on right buttock.  Given her history of splenectomy related to Hodgkin's lymphoma, she was admitted for IV antibiotic therapy (Rocephin, vancomycin, and clindamycin) for right buttock cellulitis.  She was discharged to home two days later.  MR received revealing a 2 night admission for c/o fever, chills, and sweats one day following Pneumovax and Flu vax.   Pt. noted that she had a fever the evening of her vaccines, and the following day presented to the ER per her obstetrician's instructions. She was noted to have an 8-10 cm area of expanding erythema and induration on the right buttock at the injection sites.  She was admitted for IV antibiotic therapy for right buttock cellulitis. She was discharged home. Assessment: Right buttock cellulitis.				Y	Y	2			Y	01/14/2006	01/14/2006	0	Temp at admission = 100.4 white count 29.4 Labs and Diagnostics: WBCs on admission were 29.4, rising to 33.9 the following day, and then dropping to 20.4 on day 3. H&H was slightly low.  All other labs including urine and blood cultures were WNL.  CXR showed no acute cardiopulmonary disease.	UNK	UNK	Depo Provera 150 mg IM right buttock 1/14/06 Multivitamin one PO daily	recent childbirth (1/12/06)	h/o Hodgkin's lymphoma h/o splenectomy PMH: Hodgkin's Lymphoma (post splenectomy), 4 days s/p SVD with gestational diabetes during pregnancy in good control.  Allergies: NKDA.			1						1	Cellulitis; Chills; Hyperhidrosis; Injection site erythema; Injection site induration; Malaise; Pyrexia	FLU3~SANOFI PASTEUR~U1917AA~UNK~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1117R~UNK~IM~GM~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0269601	12/22/2006	CA	45.0	45		F	12/22/2006	Patient developed itching on trunk, groin, ax  illary, and blistering on wrist. Patient went to visit her doctor, her BP was 200/110, p/111.				Y					Y	11/16/2006	11/20/2006	4	cbc, lipids, lymphocytes were decreased, monocytes were elevated, and wbc's were elevated.	UNK	UNK	atenolol, norvasc,maxide	none present. no fever.  Patient stated she was tired and stressed.				1						1	Blister; Blood pressure increased; Lipids decreased; Lymphopenia; Pruritus; White blood cell count increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71033~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0269604	12/22/2006	CO	57.0	57		F	12/22/2006	Recepient experienced immediate burning where innoculated. Was aching, tired, and nauseous within 1/2 hour of shot. Neck became sore and stiff. Symptoms lasted for about ten(10) days									Y	11/04/2006	11/04/2006	0	None	UNK	UNK	Prozac, Zantec, Estrogen, Doxepin	None	Chronic Fatigue Syndrome; Fibermyalgia; Acid Reflex Disease			1						1	Fatigue; Musculoskeletal stiffness; Nausea; Neck pain; Pain; Skin burning sensation	FLU3~SANOFI PASTEUR~U2255AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269605	12/23/2006	WA	1.01	1	.0	F	12/23/2006	17 days after patient received MMR, varicella vaccine, HiB, and PCV7, she was seen in this office with severe bruising. A platelet count was done with a result of 5000. She was hospitalized and received intravenous immunoglobulin. Followup platelt count was 42000. Platelt count on 12/4/06 was 324000, and on 12/22 was 334000. 12/28/06-Hem Onc consultation report received and reviewed DX: Isolated thrombocytopenia on CBC consistent with ITP.  RX with IVIG.			Y	Y	Y	2			Y	11/13/2006	11/29/2006	16	See above. Initial CBC was otherwise unremarkable. WBC 7.5, Hgb 12.3 Hct 36.8, Platelets less than 5,000. Diff 9% polys, 87% lymphs.	UNK	UNK		None.				1						1	Contusion; Platelet count decreased	FLU3~SANOFI PASTEUR~U2175HA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF012AA~4~IM~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0539F~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08637A~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1057F~1~IM~LL~VARICELLA (VARIVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0269608	12/23/2006	MN	53.0	53		M	12/23/2006	About 11 hrs after receiving vaccine, suddenly began to experience severe abdominal cramps, nausea, diarrhea, and body aches.  Reaction lasted for about 6 hours.									Y	12/22/2006	12/22/2006	0		UNK	UNK	Prozac, Klonopin, Omeprazole, Zocor, Ambien, Low-dose asprin		Recurrent Depression, Panic Disorder, Essential Tremor, GERD, High Cholesterol			1						1	Abdominal pain; Diarrhoea; Nausea; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0269609	12/23/2006	KY	20.0	20		F	12/23/2006	Developed a rash and swelling of the arm in which she received the vaccine.									Y	10/24/2006	10/26/2006	2	None	UNK	UNK		None	1. (#V70.0)  2003 2. (#493.90) 2000 3. (#278.00) 2003 4. (#V25.9)  2004 5. (#346.90) 2005			1						1	Injection site rash; Injection site swelling	FLU3~SANOFI PASTEUR~U2243AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0486F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0269610	12/24/2006	NC	5.0	5		F	12/23/2006	Localized pain, itching, redness, heat and swelling at injection site. Gave Benadryl for itching and swelling and possible allergic reaction and Motrin/Tylenol for pain.									N	12/21/2006	12/22/2006	1		UNK	UNK	none	end of a mild cold, only slight cough remained	none			1						1	Hypersensitivity; Injection site erythema; Injection site pain; Injection site reaction; Injection site swelling; Injection site warmth; Pruritus	FLUX~UNKNOWN MANUFACTURER~unknown~5~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0269613	12/26/2006	IN	71.0	71		M	12/26/2006	On 12/22/2006, about 2 hours post injection, patient noticed Left upper arm began to ache. No redness or bruising noted. 24 hours post injection, patient noticed swelling in Left arm extending from Left upper arm through Left forearm. Slight residual edema noticed in Left arm yet today on 12/26/2006. No redness noticed. No longer has pain in arm.									Y	12/22/2006	12/22/2006	0	None	UNK	UNK	Only takes Chemotherapy	None	Did not give info as to why taking Chemo	Soreness in arm~Pneumo (no brand name)~~0.00~In Patient		1						1	Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2245AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268910	12/27/2006	AR	52.0	52		F	12/26/2006	Mouth and hands swollen, dizzy unable to help self to bathroom. Reported by patient on 12/10/2006.  2/1/07 Received medical records from hospital which reveal patient admitted from 12/11-12/22/06 who experienced lower extremity weakness day after the flu shot & had fallen at home.  Leg weakness had been steadily increasing over 2 days with numbness of legs which started distally & spread upward.  Patient went to outlying hospital ER & was D/C.  Then hands became weak & was dropping items & patient voice started to change & had double vision.  Admit exam revealed inability to move eyes in all directions, diplopia, palate elevation impaired, prox/distal weakness, decreased sensation to pinprick, ataxic finger to nose & heel to knee to shin tests.  By the time of admit, unable to walk w/o assistance.  Quinton cath placed & received plasmapheresis x 4. Patients vision returned to normal.  Final course was held due to cardiac changes of atrial flutter which resolved when treatment d/c.  Patient received intensive PT & was then transferred to rehab facility. FINAL DX: GBS, Miller Fisher syndrome.				Y	Y		Y		N	12/08/2006	12/09/2006	1	LABS: CSF glucose 61, protein 17, WBC 1, c/s neg.  MRI of orbits was neg. EMG/NCS revealed axonal & demyelinating polyneuropathy/gangliopathy c/w Miller Fisher syndrome.	OTH	OTH	Unknown	Bursitis shoulder	Bursitis PMH: arthritis tx w/steroid shots.			1						2	Guillain-Barre syndrome; Hypoaesthesia; Dizziness; Swelling	UNK~UNKNOWN MANUFACTURER~~UNK~~~VACCINE NOT SPECIFIED (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA240AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Hospitalisation	Influenza
0269614	12/27/2006	CA	67.0			F	12/27/2006	rec'd flu shot@ 2 pm About 3 hrs later, had sore throat, then burning eyelids, then severe aches, headache, shivers, retired to bed, totally incapacitated 7.30, lay in a fetal state for 3 1/2 hrs, found an ambien hoarded away, got up at 10 am, still zonked but not aching. I think this happened to me about 10 or more years ago, have not had a flu shot since,guess I won't again!														UNK	UNK		none				1						1	Chills; Eye irritation; Headache; Pain; Pharyngolaryngeal pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0269640	12/27/2006	CO	36.0	36		M	12/20/2006	Information has been received from a registered nurse concerning a 36 year old male patient with recurrent diverticulitis, degenerative disc disease, sore throat and insomnia and a history of rib fracture and clavicle fracture from car accident (1999), splenectomy, gall stones and small bowel obstruction and no known allergies who on 11-DEC-2006 was vaccinated with a dose of PNEUMOVAX 23 (lot # 655152/0889F) (0.5 mL) in the left deltoid. Concomitant therapy that day included a dose of influenza virus vaccine (unspecified) in the same arm but different site. Other concomitant therapy included NYQUIL and ibuprofen. The patient's initial visit that day was for sore throat, he was evaluated, and given a prescription for trazadone for insomnia and amoxicillin. The patient then received the vaccinations. Within 24 hours post-vaccination the patient presented to the office with swelling of the left arm below the injection site and experienced a high fever of 104 F, chills and headache. The patient was treated with ROCEPHIN. On 13-DEC-2006 the patient appeared and swelling of left arm expanded to 5 times the original size, and patient's temperature went to 105 F. The patient was treated with 1 gram of ROCEPHIN. a CBC lab performed showed elevated WBC result of 23.5, and platelet count was elevated at 419. The patient was sent to a hospital. At the time of the report, it was unknown if the patient was hospitalized. At the time of the report the patient was considered to be not recovered. It was noted that the patient received pneumococcal 23v polysaccharide vaccine in 1999 with no untoward effects. The nurse requested a lot check. The reporter considered the patient's experiences to be disabling, life-threatening and other medical events (OMIC). Additional information has been requested.			Y	Y				Y	N	12/11/2006	12/11/2006	0	12/13/06 Platelet count 419 body temp 105F, WBC count 23.5, Body temp 12/12/06 104F.	OTH	OTH	NYQUIL, ibuprofen	sore throat	rib fracture, clavicle fracture, automobile accident, cholelithiasis, splenectomy, small intestinal obstruction, diverticulitis, intervertebral disc degeneration, insomnia		WAES0612USA02342	1						1	Activities of daily living impaired; Apparent life threatening event; Body temperature increased; Chills; Headache; Injection site swelling; Insomnia; Intervertebral disc degeneration; No reaction on previous exposure to drug; Oropharyngeal pain; Platelet count increased; Pyrexia; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0889F~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Disabling	Influenza
0269641	12/27/2006	CO	44.0	44		F	12/20/2006	Information has been received from a registered nurse concerning a 44 year old female with a history of asthma, muscle contractions, headache and fibromyalgia who on 25-SEP-2006 was vaccinated in the left deltoid with a 0.5 mL dose of PNEUMOVAX 23 (lot # 651357/0391F). Concomitant therapy included CELEXA, WELLBUTRIN XL, MIDRIN, ADVAIR, and influenza vaccine (unspecified and also administered in the left deltoid). Within 24 hours post-vaccination the patient experienced tenderness in lymph, swelling of left axillary region, aching, syncope, chills, nausea, dizziness, fever of 101.7 degrees Fahrenheit, severe headache. Reportedly with unknown treatment. On 27-SEP-2006 the patient had a complete blood count (CBC) drawn at the office and elevated 20,700 and was sent to the hospital. At the hospital the patient was given IV antibiotics, ultrasound of upper left arm. The patient was hospitalized until 01-OCT-2006 with the diagnosis of fever secondary to vaccination, and glucocytosis secondary to vaccination. At the time of the report, it was not reported if the patient recovered. The reporter considered tenderness in lymph, swelling of left axillary region, aching, syncope, chills, nausea, dizziness, fever secondary to vaccination, severe headache and glucocytosis secondary to vaccination and CBC elevated 20,700 were considered to be immediately life-threatening, disabling and other important medical events (OMIC). A lot check of concern has been requested. Additional information has been requested.			Y	Y	Y		Y	Y	Y	09/25/2006	09/25/2006	0	ultrasound, 27-SEP-2006, upper left arm; complete blood cell, 27-SEP-2006, elevated at 20,700	OTH	OTH	NIDRIN, WELLBUTRIN XL, CELEXA, ADVAIR, glucosamine		asthma, muscle spasms, headache, fibromyalgia		WAES0612USA02653	1						1	Chills; Dizziness; Full blood count abnormal; Laboratory test abnormal; Lymphadenopathy; Nausea; Pain; Pyrexia; Syncope; Tenderness; Ultrasound scan	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0391F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0269659	12/27/2006	TN	16.0	16		F	12/12/2006	On 01 Dec 2006, 57 days after receiving FluMist therapy, a 16-year old female patient with non-Hodgkin's lymphoma experienced a spontaneous abortion. The patient was a participant in the study and received study vaccine as either FluMist or placebo vaccine on 05 Oct 2006. The patient was administered FluMist as annual flu vaccine 10 Nov 2006 by her primary oncology attending physician. On 10 Nov 2006, the results of a routine urine pregnancy test were weakly positive. A repeated pregnancy test in the blood conducted on 13 Nov 2006 showed a positive result. The patient was estimated to be in the first trimester and the last menstrual period was not known. The patient's methotrexate therapy was stopped on 10 Nov 2006 and 6-mercaptopurine therapy was stopped on 13 Nov 2006, due to the pregnancy. On 01 Dec 2006, the patient experienced vaginal bleeding lasting for two to three days. A urine pregnancy test was negative on 01 Dec 2006. On 09 Dec 2006, the patient was seen in a local clinic where an ultrasound indicated that the patient had experienced a spontaneous abortion around 01 Dec 2006. The chemotherapy treatment with methotrexate and 6-mercaptopurine was resumed on 11 Dec 2006. The reporter assessed the event of spontaneous abortion as not related to FluMist therapy, but rather to the patient's methotrexate and 6-mercaptopurine therapy. (OMIC)									Y	11/10/2006	11/10/2006	0	Pregnancy test 10/05/06 negative, pregnancy test blood 11/13/06 positive, pregnancy test urine 11/10/06 weakly positive, 12/01/06 negative, Ultrasound 12/09/06 spontaneous abortion.	PVT	OTH	FluMist or Placebo mist, Methotrexate, 6 Mercaptopurine, Septra, Lidocaine cream, Ondansetron, Hydrocortisone, Cytarabine.	Non-Hodgkin's lymphoma			MEDI0005227	1						1	Abortion spontaneous; Unintended pregnancy; Vaginal haemorrhage	FLUN3~MEDIMMUNE VACCINES, INC.~500438P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0269664	12/27/2006	OK	64.0	64		M	12/20/2006	Initial report received on 15 December 2006 from a health care professional. A 64-year-old male patient, with a past medical history of hypertension, had received an injection of influenza vaccine, manufacturer unknown, lot number unknown, on 11 November 2006. Concomitant medications included Tarka, vitamins, and Lavitra as needed. There was no illness at the time of vaccination. A few days following vaccination, the patient became lethargic. He was subsequently admitted to the hospital on 25 November 2006 and diagnosed with renal failure, seizures, and hypercalcemia. All of the symptoms resolved by 29 November 2006 and, per the reporter, the patient recovered. It was unknown why this occurred.					Y	0			Y	11/11/2006				UNK	UNK	Tarka, Lavitra, vitamins		The patient had a history of hypertension.		200603495	1						1	Convulsion; Hypercalcaemia; Lethargy; Renal failure	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0269666	12/27/2006	IL	25.0	24		F		11/9 - Aching all over - progressively worse numbness to palms of hands decreased pain mid back (three ER) 11/10 - ER - All digits and both feet tingling. Hard to walk - equilibrium off - constant pain 4/3/07 Received medical records from hospital which reveal patient experienced numbness of hands & feet w/weakness of LEs & unsteady gait worsening over about 1 week since receiving flu vax on 10/25.  Admitted to hospital 11/10/06-11/16/06.  Exam revealed decreased reflexes.  Tx w/IVIG over 5 days w/ improvement & d/c to rehab as outpatient. FINAL DX: Guillain Barre Syndrome.				Y	Y	3			Y	10/25/2006	11/09/2006	15	LABS: MRI of brain & c spine were WNL.  LP revealed elevated protein of 54, WBC 2, albumin 40, glucose 62, c/s neg.	PVT	UNK			FAMILY HX: grandmothers sister has MS			1						1	Balance disorder; Difficulty in walking; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0269667	12/27/2006	IN	75.0	75		M	12/20/2006	Rash, abdominal pain. Back pain Nov 3,4,5,6. No actual treatment taken to ER given pain medicine then admitted. Ran MRIs and CTs. No diagnosis. Home keeps falling, lost all muscle tone in legs. Finally went to neurologist admit to hospital November 20 from doctor's office. November 20 given IVIG IVs for 2 hours a day for four days. Then Friday November 24 released from St Vs to RHI (rehab) for 1 week. had physical therapy intense 3 hours a day times 7 days. Was using walker when he first came home, Goes to physical therapy twice a week. No longer using a walker. Able to walk by himself. Still has tingling in fingers and toes. After coming home from St Vs November11, doctor taking care of him ordered St Vs home care, they contacted us on November 17, they were here that day.  1/18/07 Received medical records from hospital which reveal patient seen multiple times: 11/4/06 -- Seen in ER for right abdominal pain radiating to back.  Also noted to have diffuse rash on back thought to be secondary to Cipro patient was on.   Final Dx: constipation. 11/5/06 -- Seen in ER for weakness & dizziness x approx 1 week. Final Dx: vertigo. 11/6/06 -- Seen in ER for back pain s/p fall on 11/5/06. Final Dx: back contusion, arthritis LS spine. 11/6/06 -- Returned to ER later same day with dizziness, back pain & abdominal distention.  Advised to be admitted but declined. Final Dx: Compression fractures, constipation, back pain, dizziness & abdominal pain. 11/7-11/11/06 -- Return to ER & was admitted for GI work up for back pain & possible chronic appendicitis.  Patient had lost 10# over past 6 weeks due to poor appetite.  Having constipation, back pain & abdominal pain although currently resolved.  Surgery, ID, heme/onc & neuro consults done.  Possible dx: post myeloencephalopathy syndrome.  DX: possible ADEM, possibly induced by virus. 11/20-11/24/06 -- Readmitted to hospital due to progressive weakness, numbness & tingling of hands & feet. Unable to stand without max assist.  Exam revealed mild upper ext weakness & severe weakness of lower exts & was areflexic in both upper & lower exts.  Received IVIG x 4 days as well as PT/OT. FINAL DX: Guillian Barre Syndrome.			Y	Y	Y		Y		N	10/02/2006	10/19/2006	17	Spinal tap showed Guillain Barre Syndrome 11/5 LABS: CT of head revealed min bilat ethmoid sinus mucosal thickening.  MRI of brain was WNL.  CKMB were neg.  11/6 LABS: Xrays of T spine revealed compression fractures x 2 of unknown age. LS spine revealed disc degeneration & facet arthrosis. 11/7 LABS: MRI of head was WNL.  MRI of C spine revealedmultilevel cervical spondylosis & foraminal narrowing with no cord signal abnormality.  MRI of T spine revealed mild degenerative change. MRI of LS spine revealed spondylosis.  US of abdomin was WNL.  Carotid sono revealed mild stenosis bilat carotid arteries.  CT of chest revealed splenomegaly & mild emphysema.  CT of abd/pelvis revealed ileus, possible chronic appendicitis, probable liver & renal cysts, solid nodule in right kidney & splenomegaly. 11/20 LABS: CSF revealed WBC 3, RBC 13, glucose 54 & protein 88, c/s was neg.  EMG/NCS revealed abnormalities consistent with GBS or chronic inflammatory demyelinating polyneuropathy.  Had LP under fluoro.	PUB	UNK			CLL PMH: Fungal blood infection. BPH w/TURP, rotator cuff surgery 8/06.  CLL treated with chemo completed 6 mos prior secondary to huge mediastinal mass at that time.			1						1	Abdominal pain; Back pain; Fall; Guillain-Barre syndrome; Muscular weakness; Paraesthesia; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70738~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0269668	12/27/2006	PR	30.0	30		M	12/13/2006	Agitation, dizziness, vertigo, loss of concentration, hypothyroidism, memory loss, irritable mood, runny nose, nausea, nervousness, vision problems Received and reviewed records DX: hypercholesterolemia, arrythmia, hypothyroidism, Diabetes Mellitus Type II, conjunctivitis, allergic, proteinuria, generalized anxiety disorder, sleep disturbances.			Y					Y	N	11/06/2003				MIL	MIL						1						1	Agitation; Amnesia; Disturbance in attention; Dizziness; Hypothyroidism; Irritability; Nausea; Nervousness; Rhinorrhoea; Vertigo; Visual disturbance	ANTH~EMERGENT BIOSOLUTIONS~~1~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Life Threatening,Disabling	Influenza
0269669	12/27/2006	PA	68.0	68		M	12/12/2006	Pain, redness, swelling on left arm from wrist to elbow. Began symptoms 12-2-06; went to ER 12-3-06. 2 day hosp stay - unsure of Tx. Symptoms resolved mostly. Client still c/o skin scaling over left arm. 1/16/07 Received medical records from hospital which reveal patient admitted 12/3/06-12/4/06 for cellulitis of left arm where received pneumococcal vax day.  ID consult obtained. Patient d/c home on oral antibiotics.				Y	Y	2			Y	12/01/2006	12/02/2006	1	Cellulitis LAB: WBC 9.7 per MD note, no report provided.	PUB	PUB	insulin; Altase; vitamins		Diabetes PMH: IDDM, HTN			1						1	Cellulitis; Erythema; Pain; Skin exfoliation; Swelling	FLU3~SANOFI PASTEUR~U2260AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0601F~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0269673	12/27/2006	NC	5.0	5		M	12/18/2006	Developed fever up to 104 after receiving FluMist also developed cough, vomiting and petecial rash.  1/26/07 Received medical records from hospital for 12/15/-12/17/06 admit which reveal patient experienced fever, emesis & petechial rash.  Temp max 104.  Treated w/antibiotics. & d/c to home on additional oral antibiotics. FINAL DX: right otitis media; otitis externa; bronchitis; & viral illness.					Y	2			Y	12/13/2006	12/15/2006	2	LABS: Blood c/s neg.  Admit WBC 12.7, 53 segs, 33 lymphs & 11 monos, plts 169,000. D/C WBC 5.7, plts 169,000	PVT	PUB	None					1						1	Cough; Petechiae; Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500442P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0269677	12/27/2006	MI	29.0	29		F	12/26/2006	FluMist given 10/19/06 with no apparent adverse effect. Last menstrual period was 09/21/06. Patient later found to be pregnant. Patient learned she was pregnant just after taking FLUMIST, was told by manufacturer to file VAERS report just in case but no adverse effect has been noted.  Unable to provide date for non-event.									Y	10/19/2006			Prenatal tests by OB-Gyn reportedly normal.	PVT	PVT	Vitamins	NONE	NONE			1						1	Contraindication to vaccination; Drug exposure during pregnancy; Laboratory test normal	FLUN3~MEDIMMUNE VACCINES, INC.~500432P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0269678	12/27/2006	MA	36.0	36		M	12/13/2006	C/O tiredness 45 minutes after receiving vaccine. At 7:30pm 12/12/06 pt noticed bumps on nose. 12/13/06 client noticed bumps on forehead, chin, and side of nose. He also noticed redness of sclera in both eyes. At 12:05 pm 12/13/06 client reported to RN, with a macular, papular rash on forehead, left cheek, and chin, c/o generalized itchiness.									Y	12/12/2006	12/12/2006	0		PUB	UNK		NONE	NONE		MA0608	1						1	Fatigue; Ocular hyperaemia; Pruritus generalised; Rash; Rash maculo-papular	FLU3~SANOFI PASTEUR~U2198AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269679	12/27/2006	MA		43		F	12/12/2006	Tdap administered 6 months after a dose of Tdap										12/12/2006				PUB	PUB		NONE	NONE		MA0607	1						1	Medication error	FLU3~SANOFI PASTEUR~U2998AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2361AA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0269680	12/27/2006	MA	74.0	74		F	12/01/2006	On 11/01/06 I worked all day at School. I did not have a cold or any other infection that I know of. At 3pm I received a flu shot at the school. At 6:30pm, I was sitting in church and began to feel like there was a lump in my throat. It was moderately difficult to swallow, but my breathing was normal. When I got home, starting at 7:40 pm I noticed that my voice was hoarse, It became more so, each hour. My jaw and throat were painful, they ached. I took 2 Ibuprofen (200mg each), and 1 antihistamine. At first I thought I was coming down with a cold, and this is the routine I use for a cold. I took the same amount of medicine at 12:30 am and 6am. At 6am my throat was fine, could swallow ok, but both eyes were reddened, sclera beet red and both eyelids reddened and itchy. I stayed home and continued to take Ibuprofen and antihistamine as noted. By evening Thursday, 11/2, most of the eye redness was gone, jaw pain was gone. I wrote these notes on Thursday evening 11/02. Resumed usual schedule on Friday.									Y	11/01/2006	11/01/2006	0		PUB	PVT		UNK	UNK			1						1	Dysphagia; Dysphonia; Erythema; Ocular hyperaemia; Pain in jaw; Pharyngolaryngeal pain; Pruritus; Throat tightness	FLU3~SANOFI PASTEUR~U2164AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269681	12/27/2006	OK	43.0	43		F	12/07/2006	0935 c/o itching at injection site left deltoid area approx 1 1/2 circle. Given Benadryl 26mg PO. 1020 redness on arm totally gone. States itching is gone. Released to go back to work.									Y	12/07/2006	12/07/2006	0		OTH	PUB	Lisinopril, Avandia, Allegra, Thyroid, HCTZ, K+		Hydrocodone rash, Diabetic.			1						1	Injection site erythema; Injection site hypersensitivity; Pruritus	FLU3~SANOFI PASTEUR~U2284AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269682	12/27/2006	OK	58.0	57		F	12/06/2006	Shot given at 10:10am. Came to office complained of itchy to arms and hands at 11:45. Left arm 4 diameter red area. Benadryl 25mg by mouth at 12 noon and 12 pm. Complaining of neck feeling itchy. Ice pack to Left arm upon arrival. Driven to hospital. Denied shortness of breath. Hospital arrival-felt better. Receives steroid alot and prescription Prednisone, Pepcid. Returned to work 12-7-06.				Y					Y	12/06/2006	12/06/2006	0		OTH	PUB	Lotrell by mouth daily		States allergic reaction to anesthesia Dec 2005 after surgery			1						1	Pruritus	FLU3~SANOFI PASTEUR~U2284AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269684	12/27/2006	NY	28.0	27		F	12/14/2006	Developed a feeling of itchiness within entire body. No rash, no swelling, did not see primary medical doctor. Took own Benadryl at home for duration of symptoms-3 days.									Y	12/07/2006	12/07/2006	0		OTH	OTH	NONE	NONE	NONE			1						1	Pruritus	FLU3~SANOFI PASTEUR~U2284AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269685	12/27/2006	WV	60.0	60		M	12/01/2006	Right deltoid. Knot at the site of injection, warm to touch, with redness going in to the underarm, started on Thursday 11/30/06 AM. RN spoke with doctor and instructed the client to put either cool compress or warm moist compress, Ibuprofen for pain and elevate arm. Contact medical doctor if symptoms would become worse.									Y	11/29/2006	11/30/2006	1		OTH	PVT						1						1	Erythema; Feeling hot; Injection site nodule	FLU3~SANOFI PASTEUR~U2284AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1040P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0269686	12/27/2006	OH	41.0	41		F	12/19/2006	Nosebleed that evening, heavy chest, general malaise									Y	11/14/2006	11/14/2006	0	NONE	PUB	OTH	Zyrtec	NONE	Allergies-multiple (animals, trees, grass, ragweed, dust, etc.); Allergic to Penicillin. Asthma			1						1	Chest discomfort; Epistaxis; Malaise	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0269688	12/27/2006		10.0	10		F	12/13/2006	Approximately 8-10 hours after receiving Influenza vaccine, patient noted multiple hives on various body locations including legs, knee, ankles, arms, wrist, and total trunk. Positive pruristis, no pain. No fever, chills, N/U, chest pain, shortness of breath. Patient was given Benadryl and experienced symptomatic improvement. The next day fingers swollen, but hives had improved. Currently, still experiencing mild symptoms.									U	12/11/2006	12/12/2006	1	NONE	MIL	UNK	NONE	NONE	Amoxicillian			1						1	Pruritus; Swelling; Urticaria	FLU3~SANOFI PASTEUR~U2259AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269690	12/27/2006	WI	58.0	58		F	12/13/2006	Baseball sized area of tender induration at injection site surrounded by 8cm extending area of erythema. Progressed for 3 days then began regressing. Still present after one week.				Y					U	12/06/2006	12/06/2006	0	NONE	PVT	UNK	Insulin	NONE	Type 1 Diabetes Mellulitis			1						1	Erythema; Injection site induration	FLU3~SANOFI PASTEUR~U2212AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0391F~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0269691	12/27/2006	WA	10.0	9		M	12/15/2006	Onset of redness at site and slight fever (99.5) on 12/14. On 12/15 he has a linear raised lesion 1/2x1cm, with a triangular 6cmx6cm area of redness, warm to touch. Family reports this has decreased since yesterday. Patient sent in by school nurse.				Y						12/13/2006	12/14/2006	1	NONE	PVT	PUB	Finishing Augmentin for sinusitis	Sinusitis	Epilepsy, development delay, partial immune deficiency			1						1	Feeling hot; Injection site erythema; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70740~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0269693	12/27/2006	TN	76.0	75		F	12/20/2006	24 hours after injection positive with erythema, warmth and induration of injection site										12/19/2006	12/19/2006	0		PVT	UNK						1						1	Erythema; Feeling hot; Injection site induration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72219~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0959F~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0269695	12/27/2006	PA				F	12/20/2006	Vaccine received on 12/12/06. On 12/14/06 about 2-3 am, she awoke with symptoms, vomiting and aches through out body. Symptoms remained until afternoon of 12/14/06. Called 12/15/06 stated that she feels better but has some aches. Will follow with a call 12/18/06.									Y	12/12/2006	12/14/2006	2	NONE	PUB	PVT	Med for migraine headaches	NONE	Allergies taking Allegra and using inhaler.			1						1	Pain; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AF601211~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269701	12/27/2006	UT	27.0	27		F		27 year old female received age inappropriate Boostrix Tdap licensed for age 10-18.										10/17/2006				PUB	PUB						1						1	Medication error	FLU3~SANOFI PASTEUR~U2193AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B001AA~1~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0269702	12/27/2006	UT	63.0	63		M	12/04/2006	Wife calls clinic to report husband has chickenpox after vaccine. Wife says husband had had hives and pimples all over his trunk, legs and arms for two weeks but no fever. She stated husband is mad at her for making him get shot and believes the skin problems is from the vaccine. They recently changed laundry soap and wife has a history of numerous episodes of shingles. Husband has been wearing new blue jeans. Rash has not been observed or diagnosed by a medical professional. Wife states husband refuses to see a doctor and there is no immune problem. He takes blood pressure medication only (Lisinopril and Norvasc). Wife is now medication husband with her RX of Valtrex, Benadryl and cortisone cream. Patient has been attending church having physical contact with others and possibly drinking from a communal cup.									U	10/25/2006	11/20/2006	26		PUB	PVT	Lisinopril, Norvasc		High blood pressure			1						1	Acne; Rash; Urticaria; Viral infection	FLU3~SANOFI PASTEUR~U2169NA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2609AA~UNK~IM~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~0911R~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0269706	12/27/2006	KS	11.0	11		M		Severe headache began 3am 11/21/06 and abdominal pain began 8am 11/21/06. Had Abd pain off and on throughout the day. Also ran fever 101.2 that day. Was fine by am 11/22/06.				Y					Y	11/20/2006	11/21/2006	1	CBC	PVT	PVT	Focalin XR, Allergy Shot.					1						1	Abdominal pain; Headache; Pyrexia	FLU3~SANOFI PASTEUR~U2202AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2609AA~1~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0269709	12/27/2006	NV	3.0	3		M	12/15/2006	Rec'd IZ at 1230pm 12/12/06 at 530pm same day started nausea, vomiting, diarrhea lasting 12 hours taken to ER and rec'd IV fluids and anti nausea. RX 12/13/06 spiked temp 101.9 that lasted 24 hours mother gave children. Motrin temp broke today 12/15/06 child lethargic, loss of appetite.				Y					Y	12/12/2005			CBC, Electrolytes.	PUB	PUB	NONE	NONE	NONE			1						1	Anorexia; Body temperature increased; Diarrhoea; Full blood count; Laboratory test; Lethargy; Nausea; Vomiting	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B036CA~5~~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2252AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1068~4~~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0617F~3~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0269710	12/27/2006	SC	1.37	1	.4	F	12/18/2006	Developed a rash around injection site about 2 hrs post injection. Rash spread up leg, around lower back and into groin area within 24 hours. Saw doctor and diagnosed with shingles. Oral antiviral prescribed, conditions is clearing up.				Y					Y	12/06/2006	12/06/2006	0		MIL	MIL	NONE	NONE	NONE			1						1	Herpes zoster; Injection site rash; Rash; Viral infection	FLU3~SANOFI PASTEUR~U2308AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269711	12/27/2006	PA	45.0			F	12/18/2006	Got Shot one Thurs, Sat following (same week) woke up with a sore throat that hurt.														OTH	OTH		NONE	Codeine, Hydrocortisone.			1						1	Pharyngolaryngeal pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0269713	12/27/2006	AZ		0	.7	F	12/12/2006	Day after vaccination she broke out in rash on both legs and arms. C/O itching with rash. Symptoms have progressively gotten worse despite use of cortisone cream. Referred to MD.				Y					U	11/13/2006	11/14/2006	1		PUB	PUB	Sular, Cozaar	NONE	Hypertension			1						1	Rash pruritic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71830~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0269714	12/27/2006	PA	10.0	10		M	12/18/2006	Swelling of the face required ER visit.				Y					Y	12/07/2006			NONE	PVT	PUB	NONE	NONE	NONE			1						1	Face oedema	FLUN3~MEDIMMUNE VACCINES, INC.~500437P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0269715	12/27/2006	VA	29.0	29		F	12/18/2006	Influenza vaccination given left deltoid IM. Patient complain of extreme pain for 2 days better 3rd day pain in arm shooting to fingertips when raises arm. Swelling noted by patient on 12/11/06. Resolved completely by 12/15/06.									Y	12/11/2006	12/11/2006	0	NONE	PUB	PVT	NONE	NONE	NONE			1						1	Pain; Swelling	FLU3~SANOFI PASTEUR~U2307AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269717	12/27/2006	AK	64.0	64		F	11/05/2006	2 hours after shot (influenza given), patient complain of full body itching. No hives, no difficulty breathing.									Y	10/25/2006	10/25/2006	0	NONE	OTH	PUB		NONE	Diabetes, Multiple allergies: ASA, Glucotrol, Glyburide, Keflex, Levaquin, Garamycin, Gentamycin, Tylenol, TCM, EES, Septra, Zocor, Ampicillin		AK200666	1						1	Pruritus	FLU3~SANOFI PASTEUR~U2237AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269718	12/27/2006	NH	1.22	1	.2	M		Fever to 101.8 and vomiting within 12 hours of vaccination.									Y	11/29/2006	11/29/2006	0	NONE	MIL	UNK		NONE	NONE			1						1	Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~UNKNOWN MANUFACTURER~~1~~~HEP A (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~4~~~HIB (NO BRAND NAME)~1|PNC~PFIZER\WYETH~~4~~~PNEUMO (PREVNAR)~1	USA		Influenza
0269720	12/27/2006	MA	75.0	74		M	12/20/2006	Severe rash soon after flu shot 11/16/06 biopsy = erythema multiforme received course of Prednisone.									Y	11/06/2006	11/08/2006	2	biopsy	PVT	OTH		NONE	Spinocerebellar degeneration			1						1	Erythema multiforme; Rash	FLU3~SANOFI PASTEUR~U2215AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269730	12/27/2006	WI	37.0	37		F	12/27/2006	Received Flu shot 12/06/2006 at clinic (Employee Health Flu clinic). On 12/11/06 developed red spots with whites heaves on both side of face and left dermatones, per her report, left shoulder. On 12/14/06 saw doctor dermatology department started her on Valtrex 3 times a day. Home from work until resolved. Resumed work 12/18/06 reported this to EHS on 12/27/06.				Y					Y	12/06/2006	12/11/2006	5	Cared for by doctor reported at clinic.	OTH	PVT	Vitamins for Calcium	NONE	Seasonal cats, dogs, sulfa sensitivity	shingles, dizzy, sore~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Herpes zoster; Infection	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA237AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0269731	12/27/2006	GA	64.0	64		F	12/27/2006	Patient states she received pneumonia shot on 12/22/06 at 1:45 pm. She noticed her right arm began to swell and was red around 5:00 pm. She states the area around the site was red, swollen and warm to touch.				Y					Y	12/22/2006	12/22/2006	0		PUB	PVT		NONE	Penicillin, Novocaine, Codeine			1						1	Erythema; Injection site warmth; Swelling	FLU3~SANOFI PASTEUR~U2248AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0485F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0269750	12/27/2006	TX	1.0	1	.1	F	12/27/2006	12/24/2006-rash to trunk and legs, tiny distinct spots, spread to neck and face.  Possible low-grade fever.  Called physicians office, on-call nurse instructed mother to administer diphenhydramine and infant acetominophen as needed, and informed her possible adverse reaction to MMRV vaccine.  Resolved without sequelae in 2-3 days.									Y	12/13/2006	12/24/2006	11		UNK	UNK		slight cold, runny nose	prematurity-twin			1						1	Pyrexia; Rash	FLU3~SANOFI PASTEUR~UT2175AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0651F~1~IM~RL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~0466F~1~SC~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08675H~4~IM~RA~PNEUMO (PREVNAR)~1	USA		Influenza
0269752	12/27/2006	TX	1.0	1	.1	F	12/27/2006	12/22/2006 Rash appeared to trunk and legs, spreading to face and neck. Possible low-grade fever.  Called physician's office, on-call nurse informed of possible vaccine reaction and instructed mother to give diphenhydramine and infant acetominophen as needed for discomfort.  Rash resolved in 2-3 days without sequelae.  Twin received vaccine at same time and developed similar rash 2 days later.									Y	12/13/2006	12/22/2006	9		UNK	UNK		Mild cold, runny nose of a few days duration.	Prematurity, twin.			1						1	Pyrexia; Rash	FLU3~SANOFI PASTEUR~UT2175AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0651F~1~IM~RL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~1332F~1~SC~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08675H~4~IM~RA~PNEUMO (PREVNAR)~1	USA		Influenza
0269755	12/27/2006	MD	26.0	26		F	12/27/2006	Within 2 hours of recieving Influenza Vaccine patient had a 2inch wide by 1 inch long egg shaped pink swollen area below the site of injection.Complaint of itching not warm to touch Seen by physcian on duty given tylenol benadryl and a cold pack.									Y	11/20/2006	11/20/2006	0		UNK	UNK						1						1	Injection site erythema; Injection site swelling; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70737~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0269759	12/27/2006	AR	38.0	38		M	12/27/2006	On Friday the 22nd of December the referral coordinator brought a packet to PH in ref a patient that now has a suspected adverse reaction to the flu vaccination.  The patient was vaccinated on 22 Nov 06 in conjunction with his PHA.  On the 29th he presented again with URI like signs.  After treatment  - 05 Dec he was cleared to fly.  The understanding is that he was not 100% and over the course of the next week his condition degraded until on the 13th when he presented to the hospital with pronounced neurological signs and a presumptive diagnosis of encephalitis was made.  A mass was located, suspected to be a glioma and not encephalitis.  Condition degraded and the patient went to surgery for mass resection - craniotomy with submission for histopathology.  The tissue that was removed had a marked histiocytic infiltrate consistent with an infarct, along with focal areas with mild gliosis.  Not seen in the right temporal lobe is palisading necrosis, marked neuronal atypia and vascular proliferation.  Presently we are waiting for the final report.  The patient can respond to verbal yes and no question and appears to have limited sensory/feel on left side.  The portions of the record and physicals have been sent to the manufacturer so they can begin their work on this case. Sir, this lot has also been associated with other complications and was placed on medical hold by us in November.  The reactions were mainly headaches, one member however had chest pains and cardiac catheterization was performed.  The lot was cleared.			Y	Y	Y		Y		U	11/22/2006	11/29/2006	7		MIL	MIL		No, the vaccination was in conjunction with physical exam.	None			1						1	Encephalitis; Infarction; Nervous system disorder; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~U1771AA~7+~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0269760	12/27/2006	MO	1.5	1	.5	M	12/27/2006	Muscular atrophy noted at the site of injection right thigh.									U	10/30/2006	10/31/2006	1	none	UNK	UNK	tylenol was given at home before appt.	none	treated for left eyelid hemangioma with oral steroids for 6 mths beginning 8/2/05.  history otitis media.			1						1	Injection site atrophy	FLU3~SANOFI PASTEUR~U2191AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0804F~2~IM~RL~HEP A (VAQTA)~1	USA		Influenza
0269761	12/27/2006	WA	1.05	1	.0	F	12/27/2006	Patient contracted the full chicken pox disease as a result of receiving the vaccination.  She received this vaccination along with four others: Hib, inactivated flu, MMR, and pneumococcal conjugate, and was also running a mild fever of 99.9 degrees from a cold.  She developed a high fever about a week after the vaccination and developed raised spots a few days after that.  She is still sick at this time.									N	12/15/2006	12/23/2006	8		UNK	UNK	none	Running a slight fever of 99.9	none			1						1	Pyrexia; Rash; Viral infection	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~UNK~~~HIB (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0269763	12/27/2006	WI	6.0	6		M	12/27/2006	2 hours post influenza vaccine he developed vomiting and after vomiting he was nauseous but better-recovered in 24 hours.									Y	12/20/2006	12/20/2006	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Nausea; Vomiting	FLU3~SANOFI PASTEUR~U2292AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269777	12/28/2006	ID	46.0	45		F	11/21/2006	Arm started to swell several hours after injection. Swelling continued into her upper arm, shoulder, neck, throat. She took Benadryl and Allegra 180 mg and saw her primary care physician the next day. She was given a shot Prednisone taper and Allegra 180mg, which helped but did not completely relieve symptoms. She was put on Prednisone for a longer time and improved slowly over 10 days.				Y					Y	10/25/2006	10/25/2006	0	NONE	PVT	PVT	Advair 100/50 Bid, Allegra 180mg prn	NONE	Asthma, allergies			1						1	Swelling	FLU3~SANOFI PASTEUR~U2240AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0004F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0269779	12/28/2006	NJ	69.0	69		F	12/22/2006	9 days after receiving the flu shot, the patient had a sudden onset of widespread arthralgia. Gone to dr 11/25-returned 11/27. Erythocyte sedimentation rate 75 Antinuclear antibody - RA -. Pain with range of motion of joints. Symptoms decreased by 12/4/06. Erythrocyte sedimentation rate is decreasing-down to 60.									Y	11/14/2006	11/27/2006	13		PVT	PVT	Lantus, Synthroid,  Actigal, Manopal ff with		Primary biliary cirrhosis, hypertension, type II Diabetes mellitus			1						1	Arthralgia; Joint range of motion decreased; Pain; Red blood cell abnormality	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2FG01011~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0269780	12/28/2006	NY	7.0	7		M		Localized left deltoid reaction of redness/ swelling measuring 10cmx10cm. Patient complained of itching/ pain about 24 hours after injection at which time reaction was noted. No further symptom reported.				Y					Y	12/14/2006	12/15/2006	1	NONE	PVT	UNK		NONE	NONE			1						1	Erythema; Pain; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U2260AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269781	12/28/2006	MI				F	12/20/2006	Mom called and stated infant had rash on body 12-24 hours after flu shot.				Y					Y	12/18/2006	12/19/2006	1	NONE	PUB	UNK		rash around mouth-reddened eyes				1						1	Rash	FLU3~SANOFI PASTEUR~U2200KA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269782	12/28/2006	KS	1.0	1	.0	M	12/21/2006	Post vaccination measles.									U	12/11/2006	12/19/2006	8	pictures taken at 12/11/06 visit	PVT	UNK	Amoxicillin	Left otittis media, pilonidal pit, wcc	Heart murmur (pps), prematurity of birth (twin), pain arterytemis with PFO defect			1						1	Rash morbilliform; Viral infection	FLU3~SANOFI PASTEUR~U2180AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1025F~1~SC~~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|PNC~PFIZER\WYETH~B086700~4~~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0162F~1~~~VARICELLA (VARIVAX)~1	USA		Influenza
0269783	12/28/2006	IL	1.01	1	.0	M	12/21/2006	12/20/06 12:15 a.m. patient had generalized seizure lasting 1 minute. Temperature noted to be elevated to 104 degrees at this time. Paramedics called and child taken to Emergency Room for evaluation.				Y					Y	12/19/2006	12/20/2006	1	CBC, urinalysis, chest x-ray	PVT	UNK	None	None	None			1						1	Body temperature increased; Convulsion	FLU3~SANOFI PASTEUR~U2239AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~1202F~1~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08682A~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0269785	12/28/2006	HI		41		F	12/13/2006	Diarrhea, vomiting, fever, chills, worse flu in a long time. sniffles, dehydration, IV fluids needed, nausea meds, etc, ER several visits.				Y					Y	11/01/2006	11/26/2006	25	Yes in ER room on 11/08/06	UNK	UNK	Ambien, Zoloft, Buspar, Vesicare, Valtrex, Lipitor, Soma, Vicodin	Had back surgery	PTSD, High cholesterol, insomnia, genital herpes, urinary incontinence, anxiety.			1						1	Chills; Dehydration; Diarrhoea; Influenza; Nausea; Pyrexia; Rhinorrhoea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0269786	12/28/2006	WI	0.55	0	.6	M	12/20/2006	Temperature 102-104 starting within 8 hours of vaccines, along with fussiness. Lasted 2 days.									Y	12/19/2006	12/19/2006	0	NONE	PVT	PVT		NONE	NONE			1						1	Irritability; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B070BA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PNC~PFIZER\WYETH~B08670A~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0269790	12/28/2006	FL	0.2	0	.2	M	12/21/2006	On 10/26/06 influenza virus vaccine administered to 2 month old pt listed above instead of Prevnar. Was not reported to MD.									Y	10/26/2006	10/26/2006	0		PVT	PVT		NONE	NONE			1						1	Medication error	DTAP~SANOFI PASTEUR~C2489AA~1~UN~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2175BA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0757F~1~UN~LL~HIB + HEP B (COMVAX)~1|IPV~SANOFI PASTEUR~20240~1~UN~RL~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0269791	12/28/2006	VA	24.0	24		F	12/06/2006	Night of flu shot body was very cold, could not stop shivering/shaking no matter how many blankets I used, but my face felt like I could cook eggs on it. Night of flu shot and two days later knot where shot was taken,  to shoulder blades (both arms) head feels heavy almost like a headache but not.									N	05/04/2006	05/04/2006	0		OTH	PUB	NONE	NONE	NONE	See note~Influenza (Seasonal) (no brand name)~1~23.00~In Patient		1						1	Chills; Feeling cold; Feeling hot; Head discomfort; Injection site induration; Sensation of heaviness; Tremor	FLU3~SANOFI PASTEUR~U2256AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269794	12/28/2006	PA	9.0	9		M	12/15/2006	First time getting flu vaccine. rash at injection site, itchy rash.				Y					Y	12/06/2006	12/13/2006	7	NONE	PVT	PVT	PPD, Singulair	NONE	Asthma			1						1	Injection site rash; Rash pruritic	FLUX~UNKNOWN MANUFACTURER~U2197AA~UNK~IJ~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0269795	12/28/2006	NC	63.0	63		M	12/19/2006	Hurts when I raise my arm.										12/04/2006	12/04/2006	0		PUB	PUB	Actos, Renicor, Metformin, Zocor, Amaryl.	NONE	Type II Diabetes.			1						1	Pain	FLU3~SANOFI PASTEUR~U2284AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269796	12/28/2006	MA	58.0	58		F	12/18/2006	Arm red, warm, 1 inch thick swelling over 4x8 area, arm painful.									Y	12/15/2006	12/15/2006	0		PVT	UNK	Albuterol, Flonase	NONE	Asthma, Allergies: NSAIDS, Sulfa, Lido.			1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U2215AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577R~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0269797	12/28/2006	WI	44.0	44		F	12/26/2006	Shot Received 3:15pm, 5:00 PM noticed hives on midline of back and armpit area. Took 2 Benadryl. Itching subsided went to bed at 7:00pm. No hives in am. Have had flu shots before without incident.									Y	11/29/2006	11/29/2006	0	NONE	OTH	OTH		NONE	Allergies penicillin, sulfa drugs, iodine, E Mycin and Asthma.			1						1	Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0269798	12/28/2006	TN	1.78	1	.8	F	12/22/2006	Febrile seizure approximately 8 hours following administration of Flu vaccine. Highest fever 103 F. 12/29/06-records requested and received DX: Febrile seizure. FMH: febrile seizures on both sides of family. Temp in ER 103.1.  URI.				Y					Y	12/19/2006	12/19/2006	0	Urine culture normal Urine culture negative.	PVT	PVT	Tylenol and Motrin to decrease fever	None patient well	Grade 2/6 vibratory soft murmur			1						1	Febrile convulsion	FLU3~SANOFI PASTEUR~U2283AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269799	12/28/2006	HI	1.25	1	.2	M	12/20/2006	Within 15-20 minutes of immunization 3-4 cm of maculo-papular pink, non tender dermatitis at vaccination site on both left and right thighs. Without any systemic symptoms. Rash disappeared within 5 hours with no generalized symptoms.									Y	12/07/2006	12/07/2006	0	NONE	PVT	PUB	NONE	Solitary oral ulcer	11/05 immune thrombocytopenia, Iron deficiency.	Rash for 1 week~DTaP (no brand name)~3~0.50~In Patient		1						1	Dermatitis; Injection site reaction; Mouth ulceration; Rash maculo-papular	DTAP~SANOFI PASTEUR~U1857CC~4~~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U22038AA~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE863AA~4~~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B08649A~4~~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0269818	12/28/2006	FL	65.0	65		F	12/28/2006	difficulty swallowing rapid heart rate vomiting low blood pressure?				Y					Y	11/07/2006	11/07/2006	0		UNK	UNK		NONE	NONE	Delete the following info~DTP (no brand name)~~0.00~In Patient		1						1	Blood pressure decreased; Dysphagia; Heart rate increased; Vomiting	FLU3~SANOFI PASTEUR~U2248AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269821	12/28/2006	CA	32.0	32		F	12/28/2006	Pt's Symptoms were hoarsness, difficulty breathing, rapid heart beat, and throat was closing up.  The treatment by the PCP was an Epinephrine injection and pt. was given a Benadryl 50mg- 1 po q4-6 hrs Rx.				Y					U	12/22/2006	12/24/2006	2	n/a	UNK	UNK	1.  Pyradium	n/a	nkda			1						1	Dysphonia; Dyspnoea; Heart rate increased; Throat tightness	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0269823	12/28/2006	NY	84.0	84		F	12/28/2006	I passed out on street about 20 minutes after receiving the flu shot, was taken to the emergency room and spent 2 days in the hospital where they tried to determine cause of faint.  I had severe bruises on my face. 1/18/07 Received medical records from hospital which reveal patient admitted 10/30-11/1/06 after being found on the street by passerby with ecchymoes & abrasions to face & knees after leaving flu clinic.  Taken by EMS to hospital.  Regained consciousness while in ambulance w/o memory of the event. FINAL DX: Syncope.				Y	Y	2			Y	10/30/2006	10/30/2006	0	cat scan, heart moniter, MRI of head and neck, and several other tests. LABS: CT of head, MRI of head & neck, MRA of head & neck were all WNL.	UNK	UNK	levoxyl,zoloft	none	Allergic to asparagus, am hypothyroid PMH: hypothyroidism, HTN, recent onset of depression.  Heart murmur.  Had been evaluated at another hospital for possible TIA & GI bleed approx 1 mo prior to this admit.  CT/MRI were WNL at that time.	fainted~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Contusion; Loss of consciousness; Vaccine positive rechallenge	FLUX~UNKNOWN MANUFACTURER~do not know~2~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0269824	12/28/2006	CA	57.0	57		F	12/28/2006	Headaches and headpains started 36 hours after the shot and lasted over 3 weeks				Y					Y	11/29/2006	11/30/2006	1	MRI and neurological consultation and ophthamologist consult revealed normal results .Carotid Sonogram revealed no blockage(according to the client)	UNK	UNK	Maxalt and HRT	none	Allergies to Penicillin and sulfa			1						1	Headache	FLU3~SANOFI PASTEUR~U2284AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269826	12/28/2006	MS	2.0	2	.2	M	12/28/2006	Pt found unresponsive at home and brought to ED - unable to resuscitate; pronounced dead.  5/9/08 Autopsy report states COD as changes c/w viral pneumonia, bilateral & manner of death as natural. Autopsy report states patient arrested while at home & transported to ER.	Y	12/22/2006		Y					N	12/20/2006	12/21/2006	1		PVT	PUB	None		5/9/08 Had hx of being in same ER on 1/12/06, 2/9/06 & 4/6/06, all for flu like s/s w/acute febrile illness & abdominal pain.			1						1	Coma	FLU3~SANOFI PASTEUR~U2174KA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0269832	12/28/2006	CA	23.0	23		F	12/27/2006	Patient in for travel appointment, given appropriate immunization for area traveling into. Tdap given after 15 minutes. Patient noted itchy around injection site, progressed with swelling to area and redness from 25 cent size to covering all of deltoid area. Benadryl 50 mg IM given and ice pack to area.									Y	12/27/2006	12/27/2006	0		OTH	OTH	Leulen, Desmopression Acetate, Trazodone		Allergy- Codeine			1						1	Erythema; Pruritus; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA204AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|HEPA~MERCK & CO. INC.~8058F~1~IM~RA~HEP A (VAQTA)~1|TDAP~SANOFI PASTEUR~C2341AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0269837	12/28/2006	NJ	62.0	62		M	12/28/2006	tingling feet and fingers,weakness of arms and legs,difficulty swallowing,back pain, staggering, lumpy feel in throat, no reflexes arms and legs,difficulty walking and maintaining balance,back pain,motor cooridination,difficulty breathing. 2/13/07 Received medical records from hospital which reveal patient experienced progressive weakness & paresthesias of LEs with tingling & numbness for approx 4 days.  Admitted to hospital 12/9-12/14/.  Admit exam revealed areflexia & difficulty standing from squat.  Tx w/IVIG w/some improvement.  D/C to rehab hospital.  FINAL DX: most likely Guillain Barre Syndrome.			Y	Y	Y	13	Y		N	11/07/2006	12/07/2006	30	LABS: CT of head WNL.  Sed rate 17, WBC 10.1.  LP on 2/10 revealed protein 67.  EMG/NCS was WNL.	UNK	UNK		None	Type II diabetes, High blood pressure PMH: Had GI viral like illness approx 1 wk prior to admit.  Had tic bite w/o any rash which was tx w/antibiotics.  HTN; diabetes; high cholesterol; & ex-smoker (quit 2 mos ago)			1						1	Back pain; Balance disorder; Difficulty in walking; Dysphagia; Dyspnoea; Gait disturbance; Hyporeflexia; Muscular weakness; Paraesthesia; Throat tightness	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0269444	12/29/2006	LA	1.54	1	.5	M	12/22/2006	Seriousness criteria other medically significant (OMIC). Initial report received on 19 December 2006 from a health care provider. An 18 month old male patient, with no past medical history and no illness at the time of vaccination, had received a first dose, 25ml, injection of Fluzone SV 2006-2007, lot number U2245AA, on 14 December 2006. Two hours later, the patient developed a temperature of 103 degrees farenheit and had a seizure. At the time of the seizure, the patient had been napping. The patient did not have any other symptoms prior to the seizure. He was evaluated in an emergency room and observed for several hours. The patient was sent home and had no further symptoms. Other medications at the time of vaccination included Zyrtec at bedtime. The patient recovered from the event.				Y					Y	12/14/2006	12/14/2006	0		PVT	UNK					200603542	1						2	Febrile convulsion; Pyrexia; Convulsion; Pyrexia	FLU3~SANOFI PASTEUR~U2250AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2245AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0269838	12/29/2006	GU	1.86	1	.9	F	12/28/2006	R THIGH CELLULITIS, URI. COUGH, CONGESTED, FUSSY. R THIGH WARM, RED. TEMP 101(R). TREATED WITH MOTRIN.				Y					U	12/27/2006	12/28/2006	1	NONE	MIL	MIL						1						1	Cellulitis; Cough; Erythema; Feeling hot; Irritability; Nasal congestion; Pyrexia; Upper respiratory tract infection	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B070BA~4~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2259AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB130AA~1~IM~RL~HEP A (HAVRIX)~1|HIBV~MERCK & CO. INC.~0277F~3~IM~LL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08670C~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0269842	12/29/2006	IN	5.0	5		M	12/29/2006	my son went in for shots. on 12/26/2006. when he woke up on 12/27/2006. his arm and leg were swollen and bright red, and hot to the touch. i called the office on 12/27/2006 and was told thats normal because hes a large boy and to put hot compress on the sight. by that evening he was running a tep of 103.8 i gave him tylenol and his temp wouldnt go down. the redness on his arm and leg were bigger and he had blisters on his arm. i took him back to the dr on 12/28/2006 he was still running a temp. the dr informed me had an infection on the shot sights. i asked what shots were given where and he said it wasnt written down.i have no ideal what shots did this to him. the dr put him on antibiotics.and on hydroxyzine.				Y					N	12/26/2006	12/27/2006	1	none	UNK	UNK	none	none	none			1						1	Blister; Erythema; Feeling hot; Injection site infection; Pyrexia; Swelling	DTAP~UNKNOWN MANUFACTURER~~5~~~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~4~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~2~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~~2~~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0269843	12/29/2006	IN	47.0	47		F	12/29/2006	Large painful warm indurated right deltoid.				Y						12/26/2006	12/27/2006	1	CBC	UNK	UNK	Pneumovax-different site	s/p mva	none			1						1	Injection site induration; Injection site warmth; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72566~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0269844	12/29/2006	NM	22.0	22		M	12/29/2006	Pt. is suspected to have a reaction to small pox vaccine. (pericarditis).  Records received from reporter documenting an overnight hospital stay for c/o sudden onset of chest pain of 12 hours duration, 1 week following smallpox and anthrax vax.   PE: Unremarkable except for erythematous, raised bumps on anterior and sup. shoulders. Impression: 1) Atypical chest pain.  Pericarditis d/t viral(?) vs. smallpox  vaccine.  2) hyperlipidemia. Records received from VA hospital. Report as above.  Principal DX: Pericarditis.					Y				Y	12/07/2006	12/10/2006	3	Labs and Diagnostics: EKG showed mild diffuse ST elevation.  Troponin (-) x 1.  CPK slightly elevated (182 and 217), EKG did demonstrate ST elevations diffusely and PR depression in lead II c/w pericarditis.  Transthoracic echocardiogram with normal EF, no pericardial effusion. Repeat TTE 10 days later shows no significant change. CXR normal.	MIL	MIL	Meds: none, previously on Lipitor		PMH: hyperlipidemia  Allergies: NKA			1						1	Pericarditis	ANTH~EMERGENT BIOSOLUTIONS~FAV103~1~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U2308AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020072~1~IM~LA~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~Z0664~1~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Hospitalisation	Influenza
0269845	12/29/2006	DC	0.0	43		M	12/29/2006	THIS PATIENT REPORTED TODAY THAT THE FLU VACCINE HE RECEIEVED 12/4/06 PRODUCED SWOLLEN NODULES AT BOTH NIPPLES, 2 DAYS POST VACCINATION. PATIENT SEEN BY HIS OWN PHYSICIAN AND TOLD THIS WAS MOST LIKELY AN IMMUNE RESPONSE TO THE VACCINE. HIS PHYSICIAN WILL FOLLOW-UP IN ONE MONTH.									N	12/04/2006	12/06/2006	2	N/A	UNK	UNK	PREVACID, CLONAZEPAM, NASONEX	NONE	UNKNOWN			1						1	Skin nodule	FLU3~SANOFI PASTEUR~U2254AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269859	12/29/2006	MI	58.0	58		F	12/28/2006	Information has been received from a certified medical assistant concerning a 58 year old female with DILANTIN allergy who on 05 Dec 2006 was vaccainted with a first dose of pneumococcal 23v polysaccharide vaccine (lot 651437/0899F) (0.5ml), in the left deltoid. Concomitant therapy that day included a dose of influenza virus vaccine, in the right deltoid. On 07 Dec 2006 the patient called the office to report she developed swollen, red injection site reaction from deltoid around to the armpit of the same arm. The patient hurt so badly and thought she was swelling in other areas of the body. The patient went to the emergency room and was treated with Benadryl injection. The patient was not hospitalized. The patient recovered. The reporter considered the patient's experience to be an other medical event (OMIC). Additional information has been requested.				Y					Y	12/05/2006	12/07/2006	2		OTH	OTH			Drug hypersensitivity.		WAES0612USA03567	1						1	Injection site erythema; Injection site oedema; Oedema; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0899F~1~~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0269861	12/29/2006	UT		37		F	12/28/2006	2-3 lymph nodes swelled to size of grapes. They were very tender to touch 8-9/10 pain scale. Fever 101 degrees, aches from head to toe, even teeth hurt, sore throat. Patient had exacerbation same symptoms which patient had Tdap vaccination.				Y					Y	11/06/2006	11/07/2006	1		OTH	UNK		NONE	NONE	~Tdap (Adacel)~~0.00~In Patient		1						1	Lymphadenopathy; Pain; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U2218AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269862	12/29/2006	WA	0.54	0	.5	M	12/29/2006	Mom noticed head tilting to left after shots. Recheck arm torticollos with spasm of left sternoderomastoid muscle. Local warm compresses and Tylenol recommended.									U	12/28/2006	12/28/2006	0	NONW	PVT	PUB		NONE	NONE			1						1	Muscle spasms; Torticollis	DTAP~SANOFI PASTEUR~C2490AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2201EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0186F~3~IM~RL~HEP B (FOREIGN)~1|HIBV~SANOFI PASTEUR~UF052AA~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B08674E~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0269863	12/29/2006	IA	42.0	42		F	12/11/2006	Within 6 hours of vaccine developed headache, 8 hours of vaccine had myalgia. And by 12 hours severe pain throughout body, chills, stiffness, dizziness, nausea, headache for 48 hours.									Y	11/15/2006	11/15/2006	0		PUB	PVT	NONE	NONE	Allergies: morphine sulfate, keflex, penicillin, latex, poppy seeds, codeine	myalgia~Influenza (Seasonal) (no brand name)~~30.00~In Patient		1						1	Chills; Dizziness; Headache; Joint stiffness; Myalgia; Nausea; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU239AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269864	12/29/2006	PA	62.0	61		M		Flu vaccine given 12/11/06 0.5 cc IM Right deltoid. Patient stated that by 8pm he experienced breathing problem and had to use his inhaler-he could not cough anything up.-episode lasted approximately one hour. The next day he felt washed out. Has no allergy to eggs.									Y	12/11/2006	12/11/2006	0		UNK	UNK						1						1	Dyspnoea; Sensation of heaviness	FLU3~SANOFI PASTEUR~U2285AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269865	12/29/2006	MN	7.0	7		F	12/22/2006	Generalized urticaria and angioedema 8 hours after injection. No respiratory symptoms or decreased lack of consciousness. Resolved with Benadryl. Has no history of egg or other food allergies. Had 1st injection of two about									Y	12/21/2006			Radioallergosorbent test for egg allergy	PVT	PVT	NONE	NONE	NONE			1						1	Angioneurotic oedema; Urticaria	FLU3~SANOFI PASTEUR~U2212AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269866	12/29/2006	CO	79.0	78		F	12/26/2006	Onset of polyarthralgia malaise within 24 hours of vaccine administration. Duration of symptoms about 10 days, resolved with oral corticosteroid administration.				Y					Y	10/27/2006	10/28/2006	1	Positive Antinuclear antibody, elevated sedimentation rate	PVT	PVT		NONE	Hypertension, osteoporosis, peripheral vascular disease			1						1	Arthralgia; Laboratory test abnormal; Malaise	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71216~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0269868	12/29/2006	PA	28.0	27		F		Vaccine 10/25 am, woke 10/26 diffuse joint pain, swelling fingers/feet. Used Advil. 10/17-persistent pain shoulders/elbows/knees,spine, wrists painful, decreased flexion. Symptoms gradually resolved over 48 hours.									Y	10/25/2006	10/26/2006	1		PUB	UNK						1						1	Arthralgia; Musculoskeletal stiffness; Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~U2197AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269883	12/29/2006	AK	0.34	0	.3	M	12/18/2006	This case was reported by a pharmacist and described a 4-month-old male subject who was inadvertently vaccinated with a dose of diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) sooner than recommended. On 14 February 2006 the subject received 1st dose of Pediarix. On 14 February 2006, the subject then inadvertently received the 2nd dose of Pediarix. This resulted in the subject receiving more than the recommended daily dose of poliovirus vaccine. The recommended interval between the 1st and 2nd doses of Pediarix is 6 to 8 weeks. On the evening of 14 February 2006, the subject experienced a  low grade fever and fussiness. The fever and fussiness resolved on 15 February 2006. The pharmacist considered the events to possibly be related to vaccination with Pediarix.									U	02/14/2006	02/14/2006	0	Body temperature 14Feb2006 Fever	PUB	PUB		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported.		A0594835A	1						1	Body temperature decreased; Irritability; Medication error; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~~2~~UN~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269850	01/01/2007	AZ	39.0	38		M	12/31/2006	Approximately 2 months after the vaccination the patient began to experience vomiting, nausea and early satiety.  The symptoms never resolved and that patient has chronic nausea and early satiety.  Studies done revealed damage to the Vagal Nerve (presumed post viral) with resulting Gastric Antral Hypomotility and imparied Gastric Accomodation.  After 2 years of Chronic Nausea the patient required a gastric electrical stimulator placed. This improved symptoms about 50% although the patient still suffers from chronic nausea and early satiety. 03/29/07-records received from patient/reporter. Dates of service for multiple ED visits, PCP visits and GI procedures. 01/20/04-9/10/06 DX: Nausea, vomiting and anorexia of unclear etiology. weight loss, liver hemangiomas. Chronic nausea with dyspeptic symptoms with impaired gastric accommodation. HX: chronic mild episodic nausea for years without significant vomiting. Idiopathic gastroparesis with pacemaker placement. Per information received from annual follow up: My husband continues to suffer from gastroparesis; unfortunately, he recently developed POT syndrome immediately after surgery. This could also be due to a damaged vagus nurve, which in theory, could have occurred during a temporary autoimmune response after the vaccination.				Y	Y	12		Y	N	10/27/2003	01/16/2004	81	Gastric Emptying Tests-borderline prolonged  Antral-Duodenal Manometry-antral hypomotility  Vagal nerve Sham Feeding Test Study-shows vagal dysfunction  Spect Imaging For Gastric Accomadation-shows abnormal accomadation  Labs: WNL except for elevated bilirubin. CT: thickened gastric antrum. Hida scan with ejection fraction study:delayed visualization of gallbladder with normal gallbladder ejection fraction. Abdominal US 1.5cm probably cavernous hemangioma of posteriorsuperior aspect of right love of liver. Negative for helicobacter pylori.GI motility study: abnormal gastroduodenal manometry study with moderate antral hypomotility. Small bowel capsule endoscopy: Normal small intestine. Erythematous gastric fold of undetermined significance.	UNK	UNK		none	As a child had 6 month episode of unexplained nausea...then went away.  For several years prior to current illness had periodic...single day...episodes of unexplained nausea.			1						1	Dyspepsia; Early satiety; Ejection fraction normal; Endoscopy small intestine normal; Gastric emptying study; Gastrointestinal hypomotility; Haemangioma; Haemangioma of liver; Hepatobiliary scan; Impaired gastric emptying; Nausea; Nerve injury; Neurostimulator implantation; Postural orthostatic tachycardia syndrome; Viral infection; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~AU2903599~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation,Disabling	Influenza
0269479	01/02/2007	PA	51.0	51		M	12/22/2006	Initial report received on 21 December 2006 from a health care professional. A 51 year old male patient had received a right deltoid injection of Fluzone SV 2006-2007, lot number U2280AA, on 30 November 2006. Fourteen days later, the patient developed weakness and was examined in an emergency room. The site of the weakness was not identified. He was discharged to home and returned the following day with complaints of weakness and respiratory distress. He was admitted to the hospital and diagnosed with Guillain Barre syndrome. Per the reporter, the patient is currently on a ventilator with respiratory complications. There had been no illness at the time of vaccination. and no prior history of Guillain Barre syndrome. Other past medical history and other medications were unknown. At the time of this report, the patient had not recovered.				Y	Y	0			N	11/30/2006	12/14/2006	14		PVT	OTH					200603602	1						2	Asthenia; Guillain-Barre syndrome; Hypoxia; Respiratory disorder; Respiratory distress	FLU3~SANOFI PASTEUR~U2280AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0269911	01/02/2007	IL	86.0	86		M	12/21/2006	90 minutes after receipt of flu vaccine, pt complained of SOB and felt cold. Pt with prior diagnosis of COPD. Refused medical treatment. Took breathing Rx as prescribed for chronic condition. Next day had fever 100.2 F and persistent complaints of SOB. Refused to seek medical treatment. Expired later in day approximately 29 hours after immunization.	Y	11/02/2006							N	11/01/2006	11/01/2006	0	No autopsy. Death certificate lists 1 cause of death as emphysema per daughter.	PUB	UNK	UNK	COPD	COPD with emphysema.			1						1	Dyspnoea; Emphysema; Feeling cold; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA215BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Results in Death	Influenza
0269913	01/02/2007	AR	49.0	49		F	12/25/2006	That night I started aching up left arm and into neck next am. Then each day following it felt like spasms in back, shoulder working all down my back for nearly 1 week. The neck stayed for 2 weeks. Got headaches towards end. Bed rest.									Y	12/01/2006	12/01/2006	0		PUB	PUB	Cenestin		Hadn't eaten that morning needed some protein.			1						1	Headache; Muscle spasms; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0269918	01/02/2007	AK	9.0	9		M	12/21/2006	Mom reported that pt broke out with rashes from his torso down to his legs. Blotchy red itching, burning sensation. Mom stated at 2pm, he was also weak. This am all rashes resolved and not feeling weak anymore.									Y	12/20/2006	12/20/2006	0		PUB	UNK		NONE			AK200671	1						1	Asthenia; Erythema; Rash; Rash macular; Rash pruritic; Skin burning sensation	FLU3~SANOFI PASTEUR~U2237AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269919	01/02/2007	MA	34.0	34		F	12/26/2006	Pain, redness, swelling right upper arm. Pt saw her doctor on 12/20/06 and placed on Cipro 500 mg PO X07 days and Motrin 800 mg PO. Pt states she is better has rash, has very sensitive skin.				Y					Y	12/18/2006	12/19/2006	1		OTH	PUB	Unknown	NONE	Pt stated sensitive skin.			1						1	Hypersensitivity; Injection site erythema; Injection site oedema; Injection site pain; Rash; Skin disorder	FLU3~SANOFI PASTEUR~U2307AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0601F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0269927	01/02/2007	CT	34.0	34		F	12/22/2006	Initial report received on 20 December 2006, from the patient. A 34 year old female patient with no known allergies, no concurrent illnesses, no pre existing medical history, and who was not taking any medications, had received a right deltoid (route of administration not reported) dose of Fluzone SV 2006-2007 USP, lot number U2199AA on 14 December 2006, around 4:00 to 5:00 pm. Approximately two to three hours post immunization, the patient developed a fever, burning eyes, cough, difficulty breathing, and swelling of her eyes and lips. She was treated in the emergency room with Epinephrine, steroids, and Benadryl. The patient denied having any other vaccinations within four weeks of the vaccination on 14 December 2006. The reporter was unsure of the number of past flu vaccinations the patient had received, but did report there were no adverse events with any past vaccinations. At the time of this report, the patient had recovered.				Y					Y	12/14/2006	12/14/2006	0		PVT	PVT					200603598	1						1	Cough; Dyspnoea; Eye irritation; Eye oedema; Face oedema; Pyrexia	FLU3~SANOFI PASTEUR~U2199AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269929	01/02/2007	AR				M	12/27/2006	Initial report received on 22 December 2006 from a healthcare professional. A male patient received on 22 November 2006 Fluzone (lot number not provided). 2 days later, on 24 November 2006, the patient experienced flu like symptoms. 21 days post vaccination, on 13 December 2006, the patient was admitted to the hospital and diagnosed with encephalitis. Patient's outcome was not reported. No other information was provided.					Y	0				11/22/2006	12/13/2006	21		MIL	MIL					200603626	1						1	Encephalitis; Influenza like illness	FLU3~SANOFI PASTEUR~~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0269930	01/02/2007	KY	60.0	60		F	01/02/2007	11-12-06 Cardiac Arrest 3/26/07 Received Death Certificate which reveals COD as cardiac dysrhythymia & myocardial infarction with contributing factor of diabetes.	Y	11/12/2006							N	10/13/2006	11/12/2006	30		PUB	PUB	UNK	Diabetes	Diabetes			1						1	Cardiac arrest	FLU3~SANOFI PASTEUR~U2216AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0269936	01/02/2007	TN	72.0	72		F	01/02/2007	12/05/06 Pt. called had flu shot on 11/29/06.  Has had muscle soreness in left upper arm down to forearm since.  Denies redness, swelling, fever.  Pt. said she exercised arm after injection and I told her this could have aggravated area.  Pt. to call back if she continues to have problems.  1/2/07 Called pt. back re: left arm.  Says she is still having muscular pain, described as a toothache type pain that has awakened her at night-she describes this as a deep muscle ache.  She says that pain has gotten better, but she notices it more when she goes to put on her seat belt and has to reach across to put on her seat belt.  Advised pt. to see her PCP, but she has Medicare and says that the co-pay is too much (when inquired, pt. told me it is $15)-she is concerned about cost of any tests that may be incurred.  Explained that it was very important to see a physician, especially since it has been over a month since the injection was given.  Pt. voiced understanding, but is afraid of costs she may incur.  She says it has not affected her work (she is retired and only works occasionally).  Asked pt. to call me back in 2 weeks if I had not called her back.									N	11/29/2006	12/01/2006	2		UNK	UNK	Levoxyl Hormone (Estradiol) Lisinopril	No	Thyroid Disorder (Hypothyroidism) Menopausal Symptoms Mild Hyertension			1						1	Myalgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA218BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269937	01/02/2007	SD	30.0	29		F	11/14/2006	Stable and quiescent myesthenia gravis became active with right-sided weakness, pt. now unable to walk. 02/13/07-records received and reviewed for DOS 11/14-11/22/06 DC DX:Myasthenia gravis crisis Progressive weakness Respiratory distress Ileus Treated with IVIG, prednisone and mestinon. Reguired intubation and ventilator support. History of IgA deficiency. History of present illness; 24 hours after flu shot, right droopy eyelid and some left hand weakness. Has received flu shots for past 10 years without any problems. On 11/4 Seen in urgent care and treated with Mestinon. REsolved quickly. 11/6 seen in neurolgoist office with right upper extremity weakness, right ptosis and started on steroids. Weaknesses continued, unable to walk, diplopia. bilateral lower extremity weakness no complaint of headache, most recent seizure in September. PE:decreased grip strength on right, decreased strength of flexion and extension of biceps on right. Unable to move lower extremities bilaterally except for wiggling of toes. Slight abduction at hips bilaterally. Unable to produce any other movement.				Y	Y	8			U	11/02/2006	11/03/2006	1	Referred to Neurologist EEG:abnormal showing mild diffuse slowing consistent with diffuse cortical dysfunction of numerous etiologies. Duplex extremity veins:normal MRI spine:positive mild disk dehydration at L4-5 MRI Brain:stable incidental pineal cyst with otherwise negative MRI of brain. Small mucous retention cysts in maxillary sinuses CSF: culture negative, rare WBC	UNK	UNK			PMH: Diagnosed with myasthenia gravis May 1995. No record of positive on myasthenia panel. Thymectomy in October 1995.  Allergies:IgA deficient. Stadol  history of seizures asthma Gastroesophageal reflux disease			1						1	Abasia; Condition aggravated; Hemiparesis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71830~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0269946	01/02/2007	IL	53.0	53		F	01/02/2007	According to patient, approximately 5 hours post immunization experienced chills, fatigue, fever (101.2) and redness, swelling and soreness in the affected arm;unable to raise arm above her head. Saw her personal MD who placed her on antibiotics (Bactrim). By the following day, the arm was less swollen and red and the patient was released by her physician to go on vacation.									Y	11/04/2006	11/04/2006	0	None	UNK	UNK		No contraindications noted	None identified.			1						1	Chills; Erythema; Fatigue; Hypokinesia; Pain; Pyrexia; Swelling; Chills; Erythema; Fatigue; Injected limb mobility decreased; Oedema peripheral; Pain in extremity; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70384~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0618F~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70384~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~0618F~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0269961	01/02/2007	CA	0.53	0	.5	M	01/01/2007	Rt leg discrete Linear petechial rash in subcutaneous tissue spreading caudally. No fever, or systemic problems.									N	12/28/2006	01/01/2007	4	NONE	PVT	UNK	NONE	NONE				1						1	Petechiae	DTAP~SANOFI PASTEUR~C2490AA~3~~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2191BA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y10672~3~~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~B08689D~3~~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0269962	01/02/2007	CA	27.0	27		F	12/12/2006	Received TC from pt on 12/12/06 at 8:20am, c/o achy muscles, HA, nausea, sharp pains at LA/chest and SOB, stated all S/S since last NOC, at 3 hours post receiving Flu vaccine. Returned to MD ASAP. Spoke to pt after MD eval, stated was told S/S 2 hours to flu vaccine. Sent home with instructions to rest as much as possible and Motrin for pain. IF S/S worsen to ER ASAP.  12/14/06 spoke to pt by PH, states s/s reported on 12/12 now completely resolved.				Y					Y	12/11/2006	12/11/2006	0		PUB	PUB					CA060058	1						1	Chest pain; Dyspnoea; Headache; Myalgia; Nausea; Pain	FLU3~SANOFI PASTEUR~U2251AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269965	01/02/2007	KY	36.0	36		F	12/11/2006	Left upper arm pustule at site of flu with distal redness, warmth, tenderness.				Y						12/09/2006	12/10/2006	1		PVT	PVT	NONE	NONE	NONE	Deltoid redness, pain, swelling~Td Adsorbed (no brand name)~~0.00~Patient		1						1	Injection site erythema; Injection site vesicles; Injection site warmth; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBV315AA~UNK~~RA~HEP B (ENGERIX-B)~1|TD~SANOFI PASTEUR~U1880DA~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0269953	01/03/2007	NY	61.0	61		M	01/03/2007	Sore throat, slight cough,started less than 3 hours after injection. Paleness, weakness, blurring of vision, dizziness, chills 4 1/2 hours after injection chills. , Tx. Slept 3 hours, still flush & red complexion, elevated temperature so I took 200 mg Ibuprofen. will call MD in AM to report.									U	01/02/2007	01/02/2007	0		UNK	UNK	None	None	None			1						1	Asthenia; Chills; Cough; Dizziness; Flushing; Pallor; Pharyngolaryngeal pain; Pyrexia; Vision blurred	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0269972	01/03/2007	MO	0.52	0	.5	M	01/03/2007	PT RECEIVED INFLUENZA VACCINE .25 ML ON 12/27/06 AT APPROXIMATELY 11AM. LATER PRESENTED TO THE ER WITH WHEEZING AND RASH. WAS TREATED WITH BENADRYL AND WATCHED. SYMPTOMS RESOLVED. PT HAS NOT PRIOR HISTORY OF AN ALLERGIC REACTION TO EGGS.   MR received for ER visit several hours after flu vax for c/o irritability and intermittant wheezing.  Fine, erythematous rash noted on upper chest. DX: Allergic reaction.				Y					Y	12/27/2006	12/27/2006	0	NONE Labs and Diagnostics:  CXR normal.	UNK	UNK	NONE	NONE	NONE PMH: none noted.  NKDA.			1						1	Rash; Wheezing	FLU3~SANOFI PASTEUR~UT2175EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269976	01/03/2007	SC	3.0	3		F	01/03/2007	Hives - mother noticed approximately 9 hours after injection with mild increased temperature.  Given antihistamine by family physician.				Y					Y	11/30/2006	11/30/2006	0		UNK	UNK	FURODANTIN 25 MG FOR APPROX. 3 WEEKS	Urinary Tract Infection			SC0626	1						1	Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~u2247aa~5~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0269977	01/03/2007	SC	41.0	41		F	01/03/2007	Given IM injection 12/5/2006 in right deltoid - states injection site sore for one week duration. Began hurting again 12/15 and now having difficulty moving right arm without pain.  Has not take any OTC meds or used moist heat to area.									N	12/05/2006	12/15/2006	10	NONE	UNK	UNK	NONE	NONE	NONE		SC0627	1						1	Hypokinesia; Injection site pain; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA240BA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269979	01/03/2007	TX	18.0	18		F	01/03/2007	None									Y	01/03/2007	01/03/2007	0	None	UNK	UNK	none	none				1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2262AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270008	01/03/2007	OH	1.5	1	.5	F	01/03/2007	Fever 103.9, lethargic.				Y					Y	12/29/2006	12/29/2006	0		PVT	PUB						1						1	Lethargy; Pyrexia	DTAP~SANOFI PASTEUR~U1774BA~UNK~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT2200PA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0270015	01/04/2007	WV	56.0	56		F	12/18/2006	Headache, diarrhea, fever 1-2 days post injection 2-3 days post injection face swelling, LA at flu site - 1-2 inches redness.									Y	12/11/2006	12/11/2006	0		PUB	OTH		NONE	NONE			1						1	Diarrhoea; Erythema; Headache; Pyrexia; Swelling face	FLU3~SANOFI PASTEUR~U2307AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~SMITHKLINE BEECHAM~AHAVB109CB~1~IM~RA~HEP A (HAVRIX)~1|YF~SANOFI PASTEUR~UE9444AA~1~SC~LA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0270017	01/04/2007	TX	34.0			F	12/21/2006	Pt developed 2x2cm scar effect on right arm where flu vaccine was injected. (OMIC) Per 60 day follow up: Pt has residual scar effect lesion on right arm where vaccine was given.									N	10/10/2006	12/21/2006	72		UNK	UNK			NKDA Pt currently pregnant.			1						1	Injection site reaction	FLU3~SANOFI PASTEUR~U2274AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270018	01/04/2007	MA	70.0	70		F	12/13/2006	12/06/2006 Complain of right arm starting 3 hours after receiving flu vaccine on 11/30/06. Positive pain with movement of arm, occasional pain to shoulder and arm. Took Tylenol and Advil with improvement. 12/7/06 pain decrease, now only at  injection site denies redness/swelling advised to call PCP.									Y	11/30/2006	12/01/2006	1	NONE	PUB	UNK		NONE	1994 Breast cancer - lumpectomy, Chemotherapy and radiation, Emphysema, (+) smoke, increase cholesterol.		MA0611	1						1	Injection site pain; Pain; Shoulder pain	FLU3~SANOFI PASTEUR~U2299AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270019	01/04/2007	LA	83.0	83		M	12/13/2006	Client reports having his flu and PPV 23 vaccine at 12:30 p.m. on 12/12/06, at 5:00 p.m. he noticed swelling in his right arm. When he got up in the morning it was swollen from shoulder to elbow, hot with fever and painful. He took Benadryl to help. Today (12-13-06) it remain swollen, hot to touch and painful. Encouraged him to see his doctor today.										12/12/2006	12/12/2006	0		PUB	PUB	Yes - unsure	none			LA061202	1						1	Pain; Pyrexia; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA240BA~4~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0577R~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0270021	01/04/2007	WI	71.0	71		M	11/24/2006	The day after Pneumonia shot, I awoke at about 2 a.m. with cold sweats, somewhat delirious, nauseous. The next morning, the call doctor directed me to ER. My arm was swollen from shoulder to elbow, red rash, and pain.				Y					Y	11/17/2006	11/18/2006	1		PVT	UNK		NONE	NONE			1						1	Delirium; Erythema; Hyperhidrosis; Nausea; Pain; Rash; Swelling	FLU3~SANOFI PASTEUR~U2253AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0899F~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0270022	01/04/2007	NM	1.74	1	.7	M	12/22/2006	Patient developed 10 x 10 cm area of redness, edema and warmth 24 hours after receiving Dtap (INFANRIX) at site of injection. Patient seen 12/22/06 at 5:30 p.m. by MD and was given prescription for Keflex.									U	12/21/2006	12/22/2006	1	NONE	PVT	PUB	NONE	Viral Gastroenteritis	NONE	Edema, Erythema~DTaP (no brand name)~~0.00~In Patient		1						1	Feeling hot; Injection site erythema; Injection site oedema	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B042BA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2220BB~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1210F~1~IM~RL~HEP A (VAQTA)~1	USA		Influenza
0270023	01/04/2007	TN	65.0	65		F	12/20/2006	Patient last flu shot 11 years ago and at that time had a golf ball size reaction at site of injection. This time she experienced approximately 1 week to 2 weeks of extreme muscle aches and malaise. Was seen by her internist. Complete blood count, CPK and CMP all normal. Reaction lasted 2 weeks. Dr. states flu shot and not to take in future.				Y					Y	11/09/2006	11/09/2006	0	Complete blood count, creatine phosphkinase and complete metabolic profile all normal.	PUB	PUB	.5 Zanax to sleep, Flexaril for malagia	NONE	Patient states completely healthy	golf ball knot at injection site~Influenza (Seasonal) (no brand name)~1~54.00~In Patient		1						1	Malaise; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0270024	01/04/2007	CA	3.0	3		F	12/21/2006	Child had red rash, bilateral arms about 2 hours after vaccine given.									Y	12/18/2006	12/18/2006	0	NONE	PVT	PUB						1						1	Erythema; Rash	FLU3~SANOFI PASTEUR~U2307AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270027	01/04/2007	NY	57.0	57		M	12/18/2006	Severe dizziness within 1/2 hour of vaccination. Stomach queasiness the next day. Vomiting the day after that. Slow recovery with weeks of dizziness/queasiness now sporadic and slight.										11/28/2006	11/28/2006	0		PVT	OTH	NONE	NONE diagnosed	Glucose interolorant, Known hypersensitivity to mercury and thimerisol			1						1	Dizziness; Nausea; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601611~UNK~~~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0270031	01/04/2007	SD	4.0	4		M	12/28/2006	Patient started with a red area size of half dollar on 12-27-06 then redness increased to include arm from shoulder to elbow some swelling treated with Benadryl.										12/26/2006	12/27/2006	1	NONE	PVT	PUB		NONE	NONE			1						1	Erythema; Swelling	DTAP~SANOFI PASTEUR~U1891CA~5~IM~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2180AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1031~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0424F~2~SC~LA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA		Influenza
0270036	01/04/2007	HI				F	12/27/2006	Rash 6 days after immunization Flu for 4 days from 1-2 days after vaccine given.									U	12/19/2006	12/27/2006	8	NONE	PVT	PVT	Ibuprofen when flu started	NONE	NONE			1						1	Influenza; Rash	FLU3~SANOFI PASTEUR~U2238AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270037	01/04/2007	OH	1.12	1	.1	M	12/28/2006	Woke up at 2:00 am with emesis times 6 in one hour. Wheezing, pale, and fever to ER. Fever was 101.8. No treatment or laboratory tests at ER. Sent home.				Y					Y	12/27/2006	12/28/2006	1	NONE	PUB	PUB		NONE	NONE known			1						1	Pallor; Pyrexia; Vomiting; Wheezing	FLU3~SANOFI PASTEUR~UT2176BA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB113AA~1~IM~RL~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0270038	01/04/2007	MA	59.0	57		F	12/28/2006	Patient stated right arm red and hot to touch, itchy down to elbow. Saw arm MD, was placed on Benadryl 50 mg PO QD for 7 days and Zantac (OTC) PO for 7 days.				Y					Y	12/18/2006	12/19/2006	1		OTH	PUB	UNK	NONE			MA0610	1						1	Erythema; Pruritus	FLU3~SANOFI PASTEUR~U2307AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0601F~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0270039	01/04/2007	MA	80.0	80		F	12/07/2006	Patient moved her arm and indicated where she wanted the injection given. Injection was given below the deltoid - question if it was given IM or SC. Flu injection re-given on 12/06/06.									Y	11/16/2006	11/16/2006	0	NONE	PUB	PUB	Coumadin, Lanoxin, Lipitor, Lisinopril	cold for one week prior	s/p right mastectomy, atrial fibrillation, Pacemaker.		MA0612	1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2279AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270040	01/04/2007	NH	5.0	5		M	12/26/2006	Swelling in left upper arm almost twice the size of normal, redness to area covering top of arm almost down to elbow and wrapping 3/4 of way around arm, complain of itching at site,no fever, no dyspnea. Seen on 12/22 in office, no pain, no limit to movement. Treatment: Benadryl 2 tsp every 6 hours as needed and cold compresses.				Y					Y	12/20/2006	12/21/2006	1		PVT	PUB		NONE	NONE			1						1	Erythema; Pruritus; Swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B042BA~5~IM~LA~DTAP (INFANRIX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72224~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0270041	01/04/2007	NY	18.0	18		F	12/29/2006	Shortly after vaccination patient experienced fever, increased pain at injection site with localized swelling of left arm. Went to local ED 12/14/06. Saw PCP, for follow-up. Treated with OTC Benadryl.				Y					Y	12/13/2006	12/13/2006	0	NONE	PUB	PUB		NONE	NONE			1						1	Injection site pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U2285AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0270042	01/04/2007	MI	1.12	1	.1	M	12/28/2006	20 days post Varicella vaccine at local doctor's office - woke with red raised spots on face 4-5, 1 on back of neck, 2 on stomach, 1 under arm- itchy. afebrile. Family called doctor's office then local health department phone call with interview to PHN with comfort measures. 15 spots in 24 hours from onset.									Y	12/07/2006	12/27/2006	20	NONE	PVT	UNK	NONE	NONE	NONE			1						1	Erythema; Pruritus	FLU3~SANOFI PASTEUR~~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~~1~IM~~HEP A (VAQTA)~1|MMR~MERCK & CO. INC.~~1~SC~~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|PNC~PFIZER\WYETH~~4~IM~~PNEUMO (PREVNAR)~1	USA		Influenza
0270043	01/04/2007	AR	34.0	34		F	12/01/2006	Client received flu vaccine. Patient complain of burning feeling. Told patient that is most likely the medicine, and to stay the 15 minutes. PATIENT WAITED AROUND. patient left to clock out for lunch, but felt lightheaded. Patient came back to room. Patient was laid down on floor with legs elevated. Patient pulse was 88 bpm and no signs of respiratory distress. Patient complain of tightness in chest and throat area. Cool towel was given. Patient was still 88 bpm 15 minutes later. Patient complain of a tingling in her tongue with the tightness in chest. Husband stated that his wife has a past history of panic attacks. Patient not in medication. Gave 0.2 Epi SC to patient. Pulse was 96 bpm 5 minutes later patient stated that her chest felt better. Continue to watch patient for 30 minutes, and she still didn't feel right. Patient call her doctor office left message to call me back. The nurse called back, and I spoke with her and told her patients symptoms. The nurse advised for patient to go to ER. Husband took patient to ER. Reported this.				Y					Y	11/16/2006	11/16/2006	0		OTH	PVT	NONE	NONE	Panic attacks per husband			1						1	Chest discomfort; Dizziness; Paraesthesia	FLU3~SANOFI PASTEUR~U2238AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0270044	01/04/2007	AR	49.0	49		F	12/19/2006	See attached. 12/29/06 Protruding disk Left side causing pain down leg. Still had pain Left arm can not apply weight or lie on left side. Sleep 1hr/day. 1st week of November received vaccine-upper arm-extremely sore inside and outside. Could hardly lift it at all. Took TYLENOL, couple of days. Unable to lift behind my back any higher than my waist. Still extremely tendered and knotty.  Follow-up received states - upper area tender to touch immediately, continued to hurt more as each day passed - resulted in Frozen Shoulder required P.T., medication, still hurts today.				Y				Y	N	11/02/2006	11/03/2006	1	MRI; XRay; Orthopedic eval.	OTH	PVT	Robaxin, Loratab None	None	None			1						1	Immediate post-injection reaction; Injected limb mobility decreased; Insomnia; Intervertebral disc protrusion; Nodule; Nuclear magnetic resonance imaging; Pain in extremity; Periarthritis; Tenderness; Weight bearing difficulty; X-ray	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F60111~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Disabling	Influenza
0270045	01/04/2007	UT	47.0	46		M	12/22/2006	Hives on body almost daily since shot was given about 6 weeks ago. Wheezing, shortness of breath also. Now taking Methylprednisolone. (will take meds for 6 weeks)				Y					N	11/07/2006	11/09/2006	2	NONE	OTH	OTH	NONE	NONE	hay fever (sneezing)			1						1	Dyspnoea; Urticaria; Wheezing	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0270046	01/04/2007	PR	1.39	1	.4	M		Approximately 32 hours after multiple vaccinations developed sudden onset of fever and seizure activity. Due to status referred to PICU at Pediatric Hospital				Y						12/30/2006	12/31/2006	1		PVT	UNK		None	None		PR0611	1						1	Convulsion; Pyrexia	FLU3~SANOFI PASTEUR~UT2176KA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0406F~4~~~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08674B~4~~~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0270067	01/04/2007	SC	64.0	63		F	01/04/2007	11/3/2006:  PM hours following AM vaccination with influenza and PPV23 vaccines, patient reported the following symptoms:  generalized body shaking, fever, and pain.  Left arm red and warm to touch with swelling.  Duration of 2 days, after which she visited her family MD.  Prescribed Keflex 100 mg po bid for 7 days.  All symptoms subsided.				Y					Y	11/03/2006	11/03/2006	0	NONE	UNK	UNK	Cholesterol medication	NONE	Bi-lateral mastectomy		SC0628	1						1	Erythema; Injection site warmth; Pain; Pyrexia; Swelling; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70279~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0880F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0270068	01/04/2007	SC	24.0	24		F	01/04/2007	Influenza vaccine administered on Thursday, November 16th. Noticed soreness at site on Thursday evening.  On Friday, the 17th, woke at 5AM - arm very edematous (softball in size) injection site area black, blue, and purple and very warm to touch with increased soreness.  Went to clinic - patient was given Cefabroxil.  Patient follow-up: Nurse phoned patient who reported that symptoms improving with decreased edema and tenderness.				Y					Y	11/16/2006	11/17/2006	1		UNK	UNK		NONE	NONE		SC0629	1						1	Injection site swelling; Injection site warmth; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA240BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0270069	01/04/2007	FL	45.0	45		F	01/04/2007	Progressive pain and stiffness in left arm. Pain localized around shot area and radiating down arm. Muscle weakness, pain and circulation affected. Unable to raise arm above chest level. Also, a webbed mottling pattern under the skin on bicep still present after two months. The symptoms were reported to the Employee Health Dept who continues to state take 400mg of Motrin and do some exercise for the arm. Give it about two months.  This time has now expired and no improvement has been made.				Y					N	10/20/2006	10/23/2006	3	Pending physician visit.	UNK	UNK		No illness at time of vaccination.				1						1	Joint range of motion decreased; Livedo reticularis; Muscular weakness; Myalgia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0270071	01/04/2007	IL	2.0	2	.8	F	01/04/2007	AROUND 6 PM MOM NOTICED HE WAS GETTING RED AND SWOLLEN FROM THE BUTT DOWN, AND FROM SHOULDERS TO WRISTS. SHE TOOK HIM TO THE ER AND BY THAT TIME HE WAS RED ON STOMACH AND BACK. IT STARTED TO LOOK LIKE HIVES AROUND 8:30 PM. BENADRYL GIVEN AROUND 9 PM. NO BREATHING PROBLEMS. SAW PA-C ON FRIDAY. RAST TEST DONE THAT SAME DAY.									Y	12/14/2006	12/14/2006	0		UNK	UNK	ZYRTEK 1/2 TSP					1						1	Erythema; Swelling; Urticaria	FLU3~SANOFI PASTEUR~U2174DA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270072	01/04/2007	PA	83.0	83		F	01/04/2007	Received half dose of flu vaccine Nov. 11, 2006.  That day developed fever, confusion. Has had a progressive decline in cognitive function to point she is totally aphasic, bed bound, dysphagia.  Now hospitalized with what appears to be Jacob-Cruetfeldt disease whose symptoms began the day of the flu vaccine.  1/18/07 Received medical records from hospital which reveal patient admitted 12/28/06-1/5/07 with rapid onset & marked mental deteriorationfever, confusion,  global aphasia & ataxia with occasional myoclonic jerks over an approx 6 wk course beginning same day as receied 1/2 dose flu vax due to her egg allergy. Patient had been mentally intact & running her own business prior to receiving flu vax. Developed URI symptoms a few days prior to admit.  While hospitalized, continued steady decline with increased myoclonic activity & developed left facial droop. IV infiltrate site developed cellulitis & left eye developed conjunctivitis, both treated with antibiotics. FINAL DX: Jakob-Creutzfeldt disease.  Patient placed in hospice. Per 60 day follow up: Patient expired. Diagnosis JACKOB-CREUTZFELDT disease			Y	Y	Y	7			N	11/11/2006	11/11/2006	0	MRI x3 unremarkable.  EEG with periodic spikes consistent with JC Disease.  LP without evidence of infection.  14-3-3 protein not tested for. LABS: LP revealed WBC 2, RBC 30, glucose 71 & protein 51. Cytology & c/s were neg.  MRI of brain were essentially WNL. EEG revealed changes c/w Jakob-Creutzfeldt disease.  Blood labs were essentially WNL.  Swallow study revealed significant aspiration.	UNK	UNK	thyroid supplements	none	egg, beef PMH: hypothyroidism.   ALLERGIES: egg allergic reaction.			1						1	Antineutrophil cytoplasmic antibody negative; Aphasia; Blood glucose; Confusional state; Dysphagia; Electroencephalogram; Laboratory test; Lumbar puncture; Nuclear magnetic resonance imaging; Nuclear magnetic resonance imaging brain normal; Protein total; Pyrexia; Red blood cell count normal; White blood cell count	FLUX~UNKNOWN MANUFACTURER~~1~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0270073	01/04/2007	MI	48.0	48		F	01/04/2007	Arm became sore after receiving flu immunization to the point unable to sleep on it and if reaching (full extension) needs to support arm to carry out task.  Denies redness, fever swelling, rash.									U	11/21/2006	11/22/2006	1	Unknown	UNK	UNK	Unknown	Denies	Unknown			1						1	Pain	FLU3~SANOFI PASTEUR~U2247AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270079	01/04/2007	CA	0.26	0	.3	F	01/04/2007	No adverse reaction, vaccine (Flu) given to a 3 month old.									Y	12/05/2006				PVT	PUB		NONE	NONE			1						1	Wrong drug administered	FLU3~SANOFI PASTEUR~U72200AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270080	01/04/2007	CA	1.61	1	.6	M	01/05/2007	Patient experienced fevers of 101.3-101.4 with rash 4 days following administration of Hep A and flu vaccine. Parents gave Tylenol and Motrin for fever.									Y	12/15/2006	12/19/2006	4		PUB	PUB		NONE	NONE			1						1	Pyrexia; Rash	FLU3~SANOFI PASTEUR~UT2175CA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB139BA~1~IM~RL~HEP A (HAVRIX)~1	USA		Influenza
0213226	01/05/2007	MI		4		M	11/21/2003	Friday, Nov 14, 2006 had flu shot. Friday night child complained of sore arm and shoulder. Monday there was a local rash around the injection site, some redness to the arm down to the elbow, and generalized pain between shoulder and elbow. Tuesday rash was spreading down arm and unto chest and child was reporting many aching joints. Child taken to physician on Tuesday scripts for Zyrtec and Oraped new. Child does have asthma and normally has Proventil syrup. He was wheezing on Tuesday. By Thursday evening child was brought to ER and admitted because rash was getting worse, joints down to knee painful and swollen. Slurred speech, neck swollen. Child will not eat plain eggs, but can eat cake and other things made with eggs.					Y	0				11/14/2003	11/14/2003	0		UNK	UNK	Zyrtec, Oraped, Proventil		Child does not take Proventil full time 24-7. Most of his acute episodes that need treatment are in the spring and the fall.			1						2	Arthralgia; Dysarthria; Injection site erythema; Injection site pain; Injection site rash; Joint swelling; Oedema; Rash; Shoulder pain; Wheezing	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0270091	01/05/2007	SC	68.0	68		F	01/02/2007	BL leg pain, aching some weakness.  Follow-up received states - I don't know lot numbers, or any other vaccine info. Flu vaccine was given at Health Dept. - First shot was in batch that was frozen- went to have another in case 1st one wasn't any good. Stiff, trouble walking, pain in neck shoulders, arms, and hands, hands and wrist swelling, alot of pain.									Y	10/20/2006	10/27/2006	7	CBC; CPK; ANA; ESR were WNL	PUB	PUB	SYNTHROID; Calim	None	Hypothyroidism; Exam; Osteogram			1						1	Antinuclear antibody negative; Asthenia; Blood creatine phosphokinase normal; Full blood count normal; Gait disturbance; Joint swelling; Musculoskeletal pain; Musculoskeletal stiffness; Neck pain; Oedema peripheral; Pain; Pain in extremity; Red blood cell sedimentation rate normal	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0270092	01/05/2007	SC	58.0	58		F	12/11/2006	Soreness right arm onset day of injection progressively got worse each day. No redness, no fever, entire arm hurts since injection, pain seems to radiate from site of injection. Worse today than yesterday. No HX arthritis or difficulty moving arm prior to injection.				Y					N	10/20/2006	10/20/2006	0	MRI 11/30/06 as advised by MD	PUB	UNK	Thyroid med	NONE	Penicillin allergy, Hypothyroidism.			1						1	Injection site pain; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71209~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0270094	01/05/2007	NC	49.0	48		M	12/31/2006	Muscle pain, skin rash, high blood pressure, ear pain, itching									U	11/04/2003	03/01/2004	118	High cholesterol, skin rash, high blood pressure, tendonitis, dermatitis	MIL	MIL	Naproxen, Allegra, Aveeno lotion					1						1	Blood cholesterol increased; Dermatitis; Ear pain; Hypertension; Myalgia; Pruritus; Rash; Tendonitis	ANTH~EMERGENT BIOSOLUTIONS~~UNK~~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0270096	01/05/2007	CT	38.0	38		F	12/11/2006	On 12/4 10:30pm left deltoid a little red, tender. By 12am 12/5 left deltoid hot, swollen, hard to touch 3.5 diameter area. Patient experienced achiness all over. In morning of 12/5 sore throat, muscle aches. By afternoon temp 101 by mouth; site itchy. Arm normal by 12/7. Saw primary care physician on 12/11 prescribed Albuterol and Amoxicillin. No chest x-ray done.									Y	12/04/2006	12/04/2006	0		OTH	PVT		NONE	Zomeg throat closed went to ER			1						1	Erythema; Feeling hot; Injection site induration; Myalgia; Pain; Pharyngolaryngeal pain; Pruritus; Swelling; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72224~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0270103	01/05/2007	NY	1.21	1	.2	M	01/05/2007	Approximately 12 hours after receiving immunizations patient developed diffuse urticaria and fever.  Subsequently his feet became swollen and he was unable to walk.  See in ED and treated with Zyrtec and Hydeoxyzine.  All symtoms resolved within 96 hours.  2/22/07 Received medical records from hospital which reveal patient experienced pruritic rash for approx 2 days w/fever, crankiness & difficulty walking.  Derm consult done in ER.  Had already been treated by PCP w/Benadryl & Zyrtec.  Exam revealed diffuse, erythematous confluent rash & scattered targetoid lesions sparing palms & soles FINAL DX: Urticarial hypersensitivity reaction, probably viral, less likely vaccinations.				Y					Y	12/27/2006	12/28/2006	1	None LABS: WBC 13.3, monos 0.  CRP 2.32	UNK	UNK	None	Approximately 1 week prior to vaccination patient suffered from 48 hours of vomiting and diarhhea.  Patient also had intermittent cough.	None PMH: RSV bronchiolitis.  Acute gastroenteritis which had resolved 10 days prior.			1						1	Abasia; Oedema peripheral; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~UT2175BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~SMITHKLINE BEECHAM~AHAAVB141AA~1~IM~LA~HEP A (HAVRIX)~1|MMRV~MERCK & CO. INC.~1123F~1~SC~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0270105	01/05/2007	MI	17.0	16		F	01/05/2007	Client rec'd the 3 vaccines listed below @ 0935. Client went back out in the lobbly after vac. adm.-Reported that she was lightheaded-staff assisted her back to the clinic room and was placed in Trendellenburg position @ 0945 client pale & clammy, reporting nausea and seeing spots BP 110/60, P 90, R 20--0950 BP 122/70, P 90, R 20, cool cloth to forehead, still c/o symptoms persisting--1000 BP 120/70,P 100, R 24 Ammonia inhalant used--1008 BP 122/70, P 96, R 22 c/o symptoms of seeing spots, nausea & dizziness but sl. improving--1015 client offered apple juice-drank about 2 oz & stated it made her inc. nausea, client began to c/o min. shaking-covered with coat c/o SOB/chest tightness after asked by staff stated chest was tight from lower left abd to mid abd to epigastric area to mid chest- No respitory distress observed, color has much improved, no diaphoresis or clamminess assessed--1025 O2 mask 2L applied--Immediately after placing O2 she voiced that her breathing was better, but that other symptoms persist- Dr. called & notified--order to have 911 called and have client taken to ER via ambulance-client able to get onto amb. stretcher with min. assist- no ortho static changes--1035 client left via ambulance--IVF started by EMS-- ER reports client was d/c'd home after CXR and ECG completed, caretaker reported at 1400 that client was totally asymptomatic				Y					Y	01/05/2006	01/05/2006	0	ER obtained a CXR and ECG= both were negative	UNK	UNK	Clients home meds are Risperdal 0.5 mg PO Q HS & Albuterol Inh PRN	none reported	NKA--client states she has asthma.			1						1	Chest discomfort; Cold sweat; Dizziness; Dyspnoea; Nausea; Pallor; Tremor; Visual disturbance	FLU3~SANOFI PASTEUR~u2254aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0032f~2~IM~LA~HEP B (RECOMBIVAX HB)~1|MNQ~SANOFI PASTEUR~u1860aa~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0270106	01/05/2007	OK	37.0	37		M	01/05/2007	Diagnosed with Bells Palsy. Developed symptoms on 27 DEC 06.  Immunization was on 06 DEC 06.  Initial symptoms included loss of taste.  Numbness began 29 DEC 06. 1/26/07 Received medical records from hospital which reveal patient seen in ER on 12/31/06 with left facial weakness with forehead involvement & left eye tearing.  Seventh cranial nerve palsy on left c/w Bells phenomenon. Tx w/steroids, eye ointment & d/c to home to f/u with PCP.  FINAL DX: Left facial Bells Palsy.				Y					N	12/06/2006	12/27/2006	21	Currently receiving steroids	MIL	MIL	None	None	Sulfa Allergies			1						1	Ageusia; Facial palsy; Hypoaesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA244AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0270107	01/05/2007	GA	85.0	84		F	11/13/2006	Awakened on 11/11/2006 from nights sleep and felt numbness in the arm she had injection in and was unable to use arm or hand. She took 200 mg of Ibuprofen a day and Benadryl 25 mg a day since. She has swelling about the size of a half dollar and redness at injection site.Is regaining some use of that hand and arm. Has son in another state who had this exact reaction.  She has taken the Flu shot many times and has never had this reaction. Does not plan to seek care of MD at this time. But will let him know at her next visit. Has someone from the family staying with her right now and is not alone. Denies any other signs or symptoms. This reported on 11/11/06.  On 11/20/06 client reported she is totally recovered with no lingering numbness in hand or arm. Can use hand and arm without problem.									Y	11/09/2006	11/11/2006	2	None	UNK	UNK		No				1						1	Hypoaesthesia; Hypokinesia; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2244AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270109	01/05/2007	GA	57.0	57		F	11/03/2006	Flu and Pneumonia vaccine administered on 10/31/06,both in left deltoid. On 11/03/06 client came into clinic with husband complaining of swelling and tenderness of left arm at injection site. Symptoms began on 11/01/06 and has increased in severety. Has been putting ice packs on it but no other treatment.Reports no fever except at injection site. Feeling O.K. just fatigued and tired. Advised client to begin taking Ibuprofen 200 mg and follow directions on pkg. Advised to take Benedryl 50 mg according to pkg directions. Continue with cold compresses. On 11/06/2006 client reported swelling is smaller area but still has some fever in arm with tenderness. On 12/22/06 client reported she is fine and did not have to seek care of MD.									Y	10/31/2006	11/03/2006	3	None	UNK	UNK		No				1						1	Fatigue; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2253AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0674F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0270120	01/05/2007	MD	81.0			F	12/17/2003	Pancreatitis, Lipase 6686, amylase 1175, 81F, IV hydration, improved in 24 hours, lipase to 1008, amylase to 628.					Y	0								UNK	UNK						1						1	Blood amylase increased; Lipase increased; Pancreatitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0270123	01/05/2007	TN	73.0	72		F	12/20/2006	Pain in arm from elbow to upper arm and shoulder.				Y					U	11/24/2006	11/26/2006	2		OTH	PVT	Lexapro, Detrol, Vifedipine	NONE	hypertension, anxiety, bladder spasms			1						1	Pain	FLU3~SANOFI PASTEUR~U2282AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0270116	01/07/2007	ME	44.0	44		M	01/06/2007	The annual Influenza shot caused me severe pain in my right arm - from the base of my skull to the index finger on my right side (side of injection) Last year 2006 I had a reaction from the base of my skull.				Y					Y	01/06/2007	01/06/2007	0		MIL	MIL		None	None known			1						1	Pain	FLU3~SANOFI PASTEUR~U2310AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0270139	01/08/2007	IA	56.0	56		F	01/03/2007	Seriousness Criteria: Other - Medically Significant (OMIC). Initial report received on 28 December 2006 from a consumer, who is also the patient. A 56 year old female patient, received on 19 October 2006, (approximately) 0.25 ml (half dose) of Fluzone vaccine and 15 minutes post vaccination began coughing, wheezing and experienced difficulty breathing. The patient was treated with levalbuterol hydrochloride (Xopenex) and oxygen. The wheezing and difficulty breathing lasted for 2 hours. The coughing lasted for 2 days. The patient had recovered. The patient's medical history included: asthma and allergy to sulfa and IVP dye (anaphylaxis). The patient's concomitant medications included: Macadis, calcium and ASA.				Y					Y	10/19/2006	10/19/2006	0		OTH	UNK	MACADIS, CALCIUM, ASA		Asthma, allergy to sulfa and IVP dye (anaphylaxis). No illness at vaccination time. No other vaccines given within 4 weeks prior to vaccination.		200603649	1						1	Cough; Dyspnoea; Hypoxia; Wheezing	FLU3~SANOFI PASTEUR~~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0270140	01/08/2007	MO	21.0	21		M	01/07/2007	Uncontrolled shaking, passed out, shortness of breath, dizziness, vomiting.										01/07/2007	01/07/2007	0		MIL	MIL	NONE					1						1	Dizziness; Dyspnoea; Loss of consciousness; Tremor; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA243BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBV360CA~UNK~IM~LA~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB109CA~UNK~IM~LA~HEP A (HAVRIX)~1	USA		Influenza
0270142	01/08/2007	OH	31.0	31		M	12/04/2006	Client received Fluzone '06-07' influenza vaccine at 2:20 pm. At 2:40 pm employee health notified he was cold, clammy, diaphoretic. He was transported to the Emergency  Care Center per wheel chair. Placed on chart, vitals were stable. No other treatment. Discharge from hospital 20 minutes after arrival.				Y					Y	12/01/2006	12/01/2006	0	NONE	PUB	OTH	NONE	NONE	Allergy to Penicillin (as a child), hypertension (stopped meds self 2 years ago)			1						1	Cold sweat; Hyperhidrosis	FLU3~SANOFI PASTEUR~U2195AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0270144	01/08/2007	NY	1.24	1	.2	F	12/29/2006	Fine pink papular rash forehead, chest, back, diarrhea 2 days prior to this and recent mild URI symptoms.									U	12/19/2006	12/28/2006	9		PVT	PUB	NONE		NONE			1						1	Diarrhoea; Rash papular; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~U2282AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~0832F~1~~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0270145	01/08/2007	VA	20.0	19		F	12/18/2006	Initial report received from a health care professional in the USA on 12 December 2006. A 18 year old, female patient (with a medical history of no known allergies) developed a flushed, red and itchy face, 2 days after she received Fluzone (lot number U2240AA) intramuscularly in the left deltoid, Menactra (lot number U2159AA) intramuscularly in the right deltoid and Gardasil (lot number unknown) on 20 November 2006. On 24 November 2006, the patient called to reports red spots on hands. The patient did not have any illness at the time of the vaccination. She was treated with Benadryl. She was not seen at the doctor's office and has moved. It was reported that she recovered.									Y	11/20/2006	11/22/2006	2		PVT	UNK	Nevacor, Birth control pills, Celexa, Clontin		No known allergies		2006034630	1						1	Erythema; Flushing; Pruritus; Erythema; Flushing; Hypersensitivity; Pruritus; Skin burning sensation; Erythema; Flushing; Pruritus; Rash macular	FLU3~SANOFI PASTEUR~U2240A~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~~1~~UN~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2159A~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HPV4~MERCK & CO. INC.~0954F~1~IM~~HPV (GARDASIL)~2|MNQ~SANOFI PASTEUR~~UNK~~~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|FLU3~SANOFI PASTEUR~U2240AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|HPV4~MERCK & CO. INC.~~1~~~HPV (GARDASIL)~3|MNQ~SANOFI PASTEUR~U2159AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~3	USA		Influenza
0270154	01/08/2007	NC	7.0	7		F	01/08/2007	THE PATIENT COMPLAINED OF SORENESS AT THE INJECTION SITE AND LATER IN THE EVENING, HER ARM SWELLED. THE NEXT DAY, THE SWELLING AND REDNESS WAS MORE PRONOUNCED AND SHE SPIKED A FEVER OF 101 DEGREES FAHRENHEIT. ON EXAMINATION, HER LEFT DELTOID HAD A 9 CM X 9 CM X 3 CM SWELLING AND INDURATION, IT WAS ALSO TENDER AND WARM.				Y					Y	12/19/2006	12/19/2006	0		UNK	UNK	NOVOLOG	NO ACUTE ILLNESS BUT PATIENT HAS TYPE 1 DIABETES MELLITUS.	TYPE 1 DIABETES MELLITUS			1						1	Injection site induration; Injection site pain; Injection site swelling; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U2187AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577R~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0270155	01/08/2007	NY	70.0	70		F	01/08/2007	10/30/06 admitted with increased back pain and increased inability to walk.  2 weeks prior experienced viral illness (low grade temp, cough, URI). Neurology determined probable Guillain-Barre' syndrome and transferred to tertiary center for care. Areflexic, progressive weakness.  Has been transferred to nursing home now. 01/12/07-records received and reviewed from hospital.  DC and Transfer Summary:DOS 10/30-11/6/06 Seen in ER for C/O neck and shoulder pain, back and chest pain. Myocardial infarction ruled out. Day after admission had difficulty moving left arm along with pain. On subsequent exam she had clear areflexia in lower extremities with good distal strength and 3/5 strength at best in proximal lower extremities.  Neuro consult:intial assessment GBS syndrome. CT head unremarkable.  No SOB. FVC 1.5 liters respiratory alkalosis. In ICU became a bit more confused Transferred to another hospital.  PMH: diabetes and mild dementia. Several months of shoulder and low back pain gradually getting worse. Prior to admission decreased ability to walk. Weakness in extremities more proximal than distal. 2-3 weeks ago developed URI with low grade fever and coughing. Week ago had diarrhea. C/O numbness and tingling of hands and feet 1 week ago. However, family states this is old since she has a history of diabetes. 01/30/07-records received and reviewed from receiving hospital for DOS: 11/6-12/6/06 DC DX: Guillain-Barr Syndrome Anorexia LUE DVT DM Iron deficiency anemia LP:glucose 89, protein 164, 2 RBC no WBC.  Initially started on IVIG.  PMH:Alzheimer's demetia Type 2 diabetes Diabetic neuropathy with a history of left toe ulcer peripheral vascular disease history of cholelithiasis depression. Transferred to SNF.					Y	36			Y	10/19/2006	10/29/2006	10	CSF - protein 16LP elevated protein 164 few RBC no WBC.9; glucose 89 MRI of lower extremities essentially negative with degenerative changes. Cultures negative. EMG and Nerve Conduction Stdies:abnormal, evidence of a severe, acute, non-length dependent, sensorimotor polyneuropathy with both axonal and demyelinative features. Absence of evocable F-responses form 3 of 4 median and ulnar innervated muscles, the presence of A waves in 3 of 4 median and ulnar innervated muscles and presence of active denervation with reduced motor unit recruitment in weak proximal right arm muscles are suggestive of an acute inflammatory demyelinating polyradiculoneuropathy. A superimposed or underlying diabetic or hereditary neuropathy cannot be excluded. Final diagnosis: sensorimotor polyneuropathy, intermediate.	UNK	UNK			no allergies hx of dementia; HTN; diabetes mellitus type 2; hypercholestolemia PMH:Alzheimer's demetia Diabetic neuropathy with a history of left toe ulcer peripheral vascular disease history of cholelithiasis depression.			1						1	Abasia; Back pain; Guillain-Barre syndrome; Hyporeflexia; Muscular weakness	FLU3~SANOFI PASTEUR~~UNK~SC~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0270156	01/08/2007	PA	1.54	1	.5	F	01/08/2007	Mild clear nasal drainage, slight cough, temp 100.7  2/20/07 Received autopsy report which reveals COD as complications of pneumonitis.	Y	12/31/2006							N	12/29/2006	12/31/2006	2		PVT	PVT	Poly Vi Flor drops 0.25 mg		PMH: PDA treated with meds; 4 mos premature, 1.5 lbs at birth with normal growth & development now, in 96th percentile.	runny nose, temp 100.5~DTaP (no brand name)~4~1.00~In Patient		1						1	Cough; Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~UT2176AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0270166	01/08/2007	SC	47.0	47		F	01/08/2007	Received influenza immunization on 11/09/06.  Patient reported that at 6pm noted whelp the size of a lemon.  Right arm warm, sore, raised area.  Took Ibuprofen for relief without improvement.  Whelp remained approximately one week.  Muscle soreness continues without improvement.  Worsens with use.  Ibuprofen provides very little relief.									N	11/09/2006	11/09/2006	0	NONE	UNK	UNK	NONE	NONE	Hx of allergies to stings of bees, wasps, yellow jackets, and hornets		SC0630	1						1	Injection site warmth; Myalgia; Pain; Urticaria	FLU3~SANOFI PASTEUR~U2247AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270172	01/08/2007	VA	1.0			F	01/05/2007	Information has been received from a physician concerning a 12 month old female who on an unspecified date was vaccinated with a dose of ProQuad. Concomitant vaccination included influenza virus vaccine (unspecified) (manufacturer unknown). Subsequently, on the same day, the patient experienced a local reaction at the injection site while she was in the office. Medical attention was sought and the patient received diphenhydramine hydrochloride (Benadryl). The patient's status was not reported. No further information was available. There was no product quality complaint involved. The patient receiving diphenhydramine hydrochloride (Benadryl) for an injection site reaction was considered to be an other important medical event (OMIC). Additional information has been requested.				Y					Y					OTH	OTH					WAES0610USA10241	1						1	Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMRV~MERCK & CO. INC.~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0270173	01/08/2007	VA	1.0			F	01/05/2007	Information has been received from a physician concerning a 12 month old female with no allergies or pertinent medical history, who this past week, on approximately 04 Oct 2006 was vaccinated SC with a 0.5 ml dose of Proquad (lot # 654041/0662F). Concomitant vaccination included influenza virus vaccine (unspecifed) (manufacturer unknown). Subsequently, on the same day, the patient experienced a local reaction at the injection site while she was in the office. Medical attention was sought and the patient received Benadryl. Subsequently, the patient recovered. No further information was available. There was no product quality complaint involved. The patient receiving Benadryl for an injection site reaction, was considered to be an other important medical event. Additional information has been requested.				Y					Y	10/04/2006	10/04/2006	0		OTH	OTH			None		WAES0610USA08288	1						1	Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMRV~MERCK & CO. INC.~0662F~UNK~SC~UN~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0270191	01/08/2007		1.0			U	01/05/2007	Information has been received from a nurse practitioner concerning a 12 month old patient who on ten days ago approximately 13-OCT-2006 was vaccinated with a 0.5 mL dose of Proquad. Suspect vaccination administered that day included a dose of influenza virus vaccine (unspecified). Ten days ago on approximately 13-OCT-2006 the patient developed a fever, rash, cold symptoms and conjunctivitis.  Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.				Y					Y	10/13/2006	10/13/2006	0		OTH	OTH					WAES0610USA12569	1						1	Conjunctivitis; Nasopharyngitis; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMRV~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0270207	01/08/2007	KY	1.0	1	.0	M	01/05/2007	Information has been received from a certified medical assistant concerning a 12 month old male with a chronic lung disorder and no allergies, who on 14 Nov 2006 was vaccinated subcutaneously in the right arm with a 0.5 ml dose of Proquad (lot #655266/0975F). Concomitant vaccinations given on 14 Nov 2006 included: a dose of Prevnar, a dose of Vaqta and a dose of Fluzone. Other concomitant medications included: Pulmicort and Zantac. On 24 Nov 2006 the patient developed an unspecified number of lesions on his abdomen, chest and neck. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been requested.				Y					U	11/14/2006	11/24/2006	10	NONE	PVT	PVT	Pulmiocort, Zantac		lung disorder		WAES0611USA07265	1						1	Skin lesion	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~~UNK~UN~UN~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~0975F~UNK~SC~UN~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~~UNK~UN~UN~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0270211	01/08/2007		1.0			U	01/05/2007	Information has been received from a nurse practitioner concerning a 12 month old patient who on ten days ago approximately 13-Oct-2006 was vaccinated with a 0.5 ml dose of ProQuad (upgrade process). Suspect vaccination administered that day included a dose of influenza virus vaccine (unspecified). Ten days ago on approximately 13-Oct-2006 the patient developed a fever, rash, cold symptoms and conjunctivitis. Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.				Y					Y	10/13/2006	10/13/2006	0	UNK	OTH	OTH	UNK		UNK		WAES0612USA01393	1						1	Conjunctivitis; Nasopharyngitis; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMRV~MERCK & CO. INC.~~UNK~~UN~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0270145	01/09/2007	NY	19.0	19		F	01/05/2007	Information has been received from a physician concerning a 19 year old female with depression, anxiety and hypercholesterolaemia and no history of drug reactions/allergies, who on 20 Nov 2006 was vaccinated intramuscularly with the first dose of Gardasil (yeast) (0.5 mL) (lot #653938/0954F). Concomitant therapy included Seasonale, Mevacor, Celexa, and Xlonopin. Concomitant vaccinations on 20 Nov 2006 included Menactra and influenza virus vaccine (unspecified). 0n 22 Nov 2006, the patient developed facial flushing and chin itching and burning. On 23 Nov 2006, the patient developed red spots on both hands and abdomen. On 23 Nov 2006, the patient sought medical attention at an emergency room while out of town. The patient was diagnosed with having an allergic reaction and administered Benadryl. The patient fully recovered on an unspecified date. Additional information has been requested.				Y					Y	11/20/2006	11/22/2006	2	NONE	OTH	OTH	Celexa, Klonopin, Seasonale, Mevacor		depression, anxiety, hypercholesterolaemia		WAES0612USA00864	1						2	Erythema; Flushing; Pruritus; Erythema; Flushing; Hypersensitivity; Pruritus; Skin burning sensation; Erythema; Flushing; Pruritus; Rash macular	FLU3~SANOFI PASTEUR~U2240A~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~~1~~UN~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2159A~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HPV4~MERCK & CO. INC.~0954F~1~IM~~HPV (GARDASIL)~2|MNQ~SANOFI PASTEUR~~UNK~~~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|FLU3~SANOFI PASTEUR~U2240AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|HPV4~MERCK & CO. INC.~~1~~~HPV (GARDASIL)~3|MNQ~SANOFI PASTEUR~U2159AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~3	USA	Emergency room visit	Influenza
0270175	01/09/2007	NV	0.54	0	.5	F	01/08/2007	Received Pediarix, Hib, Prevnar on 12/11/06 acting strangely after vaccine not interacting with parents normally per parents seems less engaged.									U	12/11/2006	12/11/2006	0	Seeing neurologist	PVT	PVT	NONE	NONE	NONE			1						1	Abnormal behaviour	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B0691D~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2281AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF040AA~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B08689D~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0270219	01/09/2007	CO	46.0	46		M	12/19/2006	Progressive weakness felt to be consistent with Guillain Barre Syndrome at this time he is still hospitalized so final outcome unknown.  MR received from ER admit for c/o progressive weakness in lower extremities.  Weakness began 1 ½-2 weeks prior to admission, which presented  as difficulty walking and progressed to inability to ambulate on the day of admission.  PE: WNL except diminished DTRs bilaterally in lower and upper extremities.  Decreased strength in lower extremities. The patient is noted to spontaneously move extremities, however is unable to upon request. Pt. was admitted and sent to acute rehab.  Was in hospital 22 days. DX: Guillain Barre Syndrome. Record also sent for re-admission for  altered mental status 2 days after discharge 2' to hypoglycemia and residual effects of narcotics.				Y	Y		Y		N	10/31/2006	11/15/2006	15	Complete panel, CPK, lumbar puncture elevated protein, cyclosporine level. Labs and Diagnostics: WBCs 2.9, BUN 59, Creatinine 3.0, glucose 114, total bili 3.0, ALT 122, AST 173, CPK 1023, Myoglobin>2000, TSH 3.13.  CSF showed Protein of 115 . CT shows old left-sided stroke. MRI -areas of hyperintense signal c/w changes due to trauma, ischemic change, vasculitis, or demyelination. CXR mild cardiomegaly-otherwise stable.	OTH	PVT	Meds: Coumadin, Dilaudid, Cyclosporine, Synthroid. Diltiazem, Lasix, Lantus insulin, Flexeril, Axid, Combivent PRN.	Renal insufficiency, liver transplant	Type II DM, DVT, Renal insufficiency, HTN, Hep C, Liver transplant. PMH: Diabetes, Hep C s/p liver transplant, hypothyroidism, peripheral neuropathies, DVT 9/2006. Allergies: PCN.			1						1	Asthenia; Guillain-Barre syndrome; Laboratory test abnormal	FLU3~SANOFI PASTEUR~U2251AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0270220	01/09/2007	WA	5.0	5		M	01/04/2007	About 8 minutes after flu injection mother returned with client who was coughing, wheezing and face red. 10 minutes after injection evaluated by MD, Adrenalin 0.1 cc 1/1000 SQ. Evaluated by MD nebulizer treatment with xopenex 0.63 given. 20 minutes after injection (flu) Benadryl 25 mg PO. Admit to facility same day.   MR received from hospital for ER admit for anaphylactic reaction occuring within 30 minutes of flu vax.  Child initially began coughing and then had increased difficulty with breathing.  Child was brought back to pediatrician's office where he was given Benadryl and epinephrine and sent to the ER.  Upon arrival to the ED he was found to be wheezing. Txd with IV Benadryl, SoluMedrol, and H2 blocker and albuterol nebs PRN. Discharged in stable condition the next day. Discharge DX: Anaphylactic reaction to Influenza vaccine. 01/17/2007 PCP note received-no new MedDra codes.				Y	Y	1			Y	01/03/2007	01/03/2007	0		PVT	UNK	Meds: none.		Hx of asthma, H/o transposition of great vessels, surgically corrected, VSP.  PMH: Congenital heart disease (transposition of the great arteries) s/p surgical correction. Reactive airway disease. Hx of RSV bronchiolitis.  Allergies: none.			1						1	Cough; Erythema; Wheezing	FLU3~SANOFI PASTEUR~U2281AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0270222	01/09/2007	TN	67.0	67		F	12/27/2006	Tingling in fingers on L hand, aching and soreness from shot site (L del IM) down to finger tips. Started immediately. Also complaining for dry mouth. Unable to do BP, Pulse on 80, nailbeds reactive, due to breast cancer.									Y	12/27/2006	12/27/2006	0		PUB	PUB	B12, Calcium, Atenolol		Breast cancer in 1998, oral cancer in 2004, High blood pressure.		TN06037	1						1	Dry mouth; Injection site pain; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U2283AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270224	01/09/2007	OR	46.0	46		F	12/29/2006	Few hours after flumist dev fever and itchy rash all over. SX resolved within one hour.									Y	12/11/2006	12/11/2006	0		PVT	PVT	UNK	NONE	NONE			1						1	Pyrexia; Rash pruritic	FLUN3~MEDIMMUNE VACCINES, INC.~500430P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0270226	01/09/2007	OH	11.0	11		M	12/14/2006	1 day post vaccine injection, contract dermatitis around the droppage site where serum dripped from the needle site, after needle popped out.									U	12/11/2006	12/12/2006	1		PVT	PVT		Slight cough	Eczema			1						1	Dermatitis contact; Injection site reaction	FLU3~SANOFI PASTEUR~U2307AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270227	01/09/2007	MI	60.0	60		F	01/03/2007	Hives occurred about 7 1/2 hours after injection. Extreme itching. I took 2 OTC Diphenhydramine Hydrochloride 25 mg tablets and used 1% hydrocortisone cream. Hives went away and itching stopped. However I continued to have out breaks for the next 8 days, which would subside by using the tablets and cream.									Y	12/20/2006	12/20/2006	0		PVT	UNK	Nexium, Actonel, Zocor	Recovering from head cold onset 12/12/06, Finished a 7 day course of Bactrim on 12/17/06 for a UTI onset 12/09/06, finished a 2 day course of Pyridium on 12/16/06 for UTI.	I had an allergic reaction to Avalox, I am allergic to bee stings, I am not allergic to eggs.			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~42254AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270228	01/09/2007	WA	0.17	0	.2	F	12/29/2006	Fine, Maculo papular rash 1 day after receiving flu shot.									Y	12/27/2006	12/28/2006	1		MIL	UNK		NONE	Esophageal reflux			1						1	Rash maculo-papular	FLU3~SANOFI PASTEUR~U2310AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270229	01/09/2007	NY	1.24	1	.2	F	01/02/2007	Erythema, swelling left lateral thigh at injection site, developed about 3 days after injection increased in size, tenderness over next week. Developed pink papular rash over trunk and proximal extremities over past 24 hours.				Y					U	12/21/2006	12/24/2006	3		PVT	OTH		NONE	NONE			1						1	Injection site erythema; Injection site oedema; Rash papular; Skin discolouration; Tenderness	FLU3~SANOFI PASTEUR~U2282AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~0832T~1~SC~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0270230	01/09/2007	NY	4.0	4		M	01/03/2007	L thigh cellulitis at administration site, treated with Keflex.									U	12/11/2006	12/12/2006	1		OTH	UNK	NONE	Otitis Media, Asthma	H/O asthma			1						1	Cellulitis; Injection site reaction	DTAP~SANOFI PASTEUR~C2627AA~1~IM~LL~DTAP (DAPTACEL)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72005~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~Y1068~5~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~~2~SC~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0270232	01/09/2007	NY	51.0	51		M	12/07/2006	Patient called to report onset of sl fever, chills, achy beginning about midnight following vaccination for influenza earlier in day (patient did not know exact temp but states felt slightly feverish).									Y	12/06/2006	12/07/2006	1		PUB	PUB		NONE				1						1	Chills; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2284AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270233	01/09/2007	MA	74.0	74		F	01/01/2007	Temp 100-101 Sun and Mon in bed, asleep, for Sun and Mon, Body aches.									Y	12/02/2006	12/03/2006	1	Urine test negative	PUB	UNK	Vasotec, HCTZ, Atenolol	NONE	High blood pressure, Mitra val prolapse, Knee ACL			1						1	Pain; Pyrexia; Somnolence	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270238	01/09/2007	MT	54.0	54		M	12/28/2006	Fever/chills/body aches for 48 hours. Ibuprofen 600 mg twice a day. Slept alot.									Y	11/09/2006	11/10/2006	1	NONE	OTH	PVT	Methtrexate		psoriasis			1						1	Chills; Pain; Pyrexia; Somnolence	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F600311~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0270280	01/09/2007	IN	5.0	5		F	12/29/2006	Induration on right thigh, mild cellulitis 2 days post vaccination. Treated with Benadryl, warm packs, and Keflex. 1/3/07 Mom reported redness gone, still slight tender.									Y	12/27/2006	12/29/2006	2		PVT	PVT		NONE	NONE			1						1	Cellulitis; Injection site induration; Tenderness	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B040BA~5~SC~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2174GA~1~SC~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0420~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0707F~2~SC~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA		Influenza
0270294	01/09/2007	PA	58.0	58		F	01/09/2007	Patient states of right arm tingling and numbness at times ever since receiving influenza vaccine.									U	11/07/2006			EMG & NCS ordered on 1/8/07 when provider notified of right arm tingling & numbness.  Testing date pending.	UNK	UNK	Adult Aspirin 81 mg daily, Calcium + D 600/200mg, 1 BID, Vitamin E 1000 IU, 1 tablet daily, Pamelor 50mg, 1 HS PRN, Lecithin 400mg, daily, Percocet 5/325 mg BID PRN.		Fibromyalgia, joint pain, arthritis, hyperlipidemia.			1						1	Hypoaesthesia; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70621~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0270297	01/09/2007	HI	1.5	1	.5	M	01/09/2007	Mom states child was shaking and wobbly for about 5 minutes no LOC, vomited once afterwards, cranky, whiny today, otherwise tolerating oral fluids well.									Y	01/08/2007	01/08/2007	0		UNK	UNK						1						1	Irritability; Tremor; Vomiting	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B035AA~4~IM~UN~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2259AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB143BA~1~IM~UN~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1066F~1~IM~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0270309	01/09/2007	NC	5.0	5		M	12/22/2006	Patient in with sore throat, fever, and scarlet rash. SA positive diagnosed with Strep pharynigitis with scarlitone form rash. Mom asked me to look at injection site where he received his Influenza vaccine 3 days prior. The injection site was swollen and erythematous and somewhat tender. Treated with Keflex 250 mg/5 ml 1 1/2 tsp TID for 6 days.				Y					Y	12/19/2006	12/22/2006	3	SA positive	PVT	UNK		Streptococcal Pharynigitis			NC07003	1						1	Injection site erythema; Injection site swelling; Pharyngolaryngeal pain; Pyrexia; Rash scarlatiniform; Tenderness	FLU3~SANOFI PASTEUR~U2271AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0270310	01/09/2007	PA	16.0	16		M	12/21/2006	Administered Fluarix to 16 1/2 year old patient vaccine is for 18 years and older.									Y	11/22/2006	11/22/2006	0	NONE	PVT	PVT		NONE	Asthma			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA231BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0270311	01/09/2007	VA				F	01/09/2007	2 weeks after receiving vaccines presented to office with diffuse macular rash on face, scalp, chest and back. No other symptoms.									Y	12/20/2006	01/03/2007	14		PVT	PVT	Robitussin cold medicine	Bronchitis pharynigitis				1						1	Rash macular	FLU3~SANOFI PASTEUR~U2166AB~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1096F~1~IM~LL~HEP A (VAQTA)~1|HIBV~SANOFI PASTEUR~UE978AA~4~IM~LL~HIB (ACTHIB)~1|MMRV~MERCK & CO. INC.~1119F~1~IM~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0270316	01/10/2007	NH	58.0	58		M	11/14/2006	Unclear relation- no prodromal viral illness- had Flu shot now with Guillian Barre Syndrome. (OMIC).  1/22/07 Received medical records from hospital which reveal patient admitted 12/12-12/25/06 for weakness of his legs.  Exam revealed areflexia of the LEs.  Neuro consult & EMG done & dx w/GBS. No LP done with this admission.  Treated w/IVIG x 5 days w/considerable improvement.  D/C to home w/home health for PT & tapering prednisone for prurtis to IVIG. Patient was readmitted to hospital on 12/17-12/22/06 with recurrence of GBS.  S/S of weakness of LEs esp below the knee with dull aching.  Exam revealed areflexia below the knees.  LP done in ER.  Received additional IVIG over 5 days. FINAL DX: Guillain Barre Syndrome.										10/19/2006	11/12/2006	24	LABS: CBC & chem were WNL, ESR 2.  Doppler & MRIs were neg.  EMG done 12/13 was c/w GBS. LP done 12/17 revealed increased protein of 95.5.	UNK	UNK			06/06 shoulder fracture  PMH: PTSD, bipolar disorder, left shoulder fracture s/p syncope with infection & removal of hardware 10/06, essential tremor & hypothyroidism.			1						1	Guillain-Barre syndrome	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA213AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0270318	01/10/2007	WA	68.0	68		F	12/27/2006	About 1 week after receiving Flu vaccine, pt started developing weakness in her feet which progressed in an ascending fashion to involvement of bilateral upper extremities. Pt has lumbar puncture which showed albuminocytolocic dissociation, and an EMG that was consistent with GUILLAIN BARRE syndrome with motor and sensory axonal neuropathy. Pt was endotracheally intubated due to impending respiratory failure and initially had signs of autonomic instability with labile blood pressure, which eventually stabilized. Pt received IVIG daily for 5 days. Pt was discharged to a rehabilitation center requiring PEG placement for tube feedings. Pt was normally healthy, walked daily prior to events above. 02/09/07-records received and reviewed from Harborview Medical Center for DOS 11/28-12/17/06-DC DX: GUILLIAN-BARRE syndrome (acute motor and sensory axonal neuropathy). Non-ST elevated myocardial infarction. Postmenopausal bleed. Type 2 diabetes 9new diagnosis), Hypertension, Urinary tract infection, Anemia or chronic disease, Dysphagia. Percutancious endoscopic GT inserted. CT Chest:partial collapse of lower lobes. HX present illness: Six days prior to admission noted weakness in feet progressed in an ascending fashion and at time of presentation involved bilateral upper extremities. Symptoms of tingling and numbness began about the same time and progressed in similar distribution. Seen in ER and admitted to SNF where she was diagnosed with type 2 diabetes.  PMH:new diagnosis of type 2 diabetes, hypertension. PE: bilateral ptosis, variable facial sensory exam, bilateral facial motor weakness, especially with puffing out her cheeks. Weak gag reflex, trapezius symmetrically strong but somewhat weak. Decreased light touch pinprick and temperature sensation throughout especially below her clavicles bilaterally. Stocking pattern in feet. Respiratory failure on admission required intubation and subsequently extubated.   RX with 5 days of IVIG. Per annual follow up: As of 12/17/2006 pt was discharged to skilled nursing facility with significant improvement of weakness but has not been seen at our hospital since that time. Pt still had dysphagia and required P.E.G. placement for tube feeding.			Y		Y	19			U	11/20/2006	11/28/2006	8	LP:albuminocytologic dissociation. EMG:abnormal, evidence of severe motor and sensory peripheral neuropathy with predominantly axonal loss.  Fiberoptic endoscopy showed erythematous arytenoids, atrophic vocal cords with granulation tissue noted on bilateral mid-cords, erythema abnormalities in subglottic regions.	UNK	UNK			Non smoker, no alcohol or drug use. New onset Type 2 Diabetes. Hypertension, Break through vaginal bleeding. Anemia or chronic disease			1						1	Anaemia; Asthenia; Dysphagia; Electromyogram; Endoscopy; Endotracheal intubation; Guillain-Barre syndrome; Hypertension; Hypokinesia; Hypoxia; Laboratory test abnormal; Lumbar puncture; Myocardial infarction; Neuropathy; Postmenopausal haemorrhage; Respiratory failure; Sensory disturbance; Urinary tract infection	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0270321	01/10/2007	IN	9.0	9		M	01/10/2007	Vaccine was administered on Friday 01/05/07, On Monday 1/8/07. Patient developed a rash and itching over trunk, back, behind knees. Mother administered Benadryl rash has subside. No fever.									Y	01/05/2007	01/08/2007	3	NONE	PUB	PUB		NONE	NONE			1						1	Rash	FLUN3~MEDIMMUNE VACCINES, INC.~510439P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0270324	01/10/2007	FL	5.0	5		M	01/04/2007	Pt developed rhinorrhea, sneezing, eyelid swelling about 20 after vaccination. Pt given dose of Benadryl then returned to office 20 persistent eyelid swelling. Received Benadryl, PN, Observe closely									Y	01/04/2007	01/04/2007	0		PVT	PVT	Zyrtec, Xopenex, Pulmicort.		Allergic rhinitis, Asthma			1						1	Eyelid oedema; Rhinorrhoea; Sneezing	FLU3~SANOFI PASTEUR~U2312AA~4~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0910F~2~IM~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0270325	01/10/2007			31		F	12/18/2006	Flu shot given 11/16/06 joint pain and swelling. Both ankles sore and swollen for 3-4 days.										11/16/2006	11/17/2006	1		UNK	UNK			Allergic to Ibuprofen ASA			1						1	Arthralgia; Joint swelling; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71832~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0270331	01/10/2007	WA	64.0	64		F	01/10/2007	About 5-7 days after infection had upper right arm pain  and pain lifting arm above shoulder level.  Arms are sore when lifted, painful when lifted above shoulders or stretching to side.									U	11/27/2006	12/04/2006	7	NONE	PUB	UNK		NONE	NONE			1						1	Injection site pain; Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~U2253AA~UNK~SC~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270336	01/10/2007	OK	20.0	20		F	01/10/2007	Facial flushing; itching of the face, neck and arms; fine rash on arms.  Benadryl taken.									Y	01/09/2007	01/09/2007	0		UNK	UNK		None	None			1						1	Flushing; Pruritus; Rash	FLU3~SANOFI PASTEUR~UT2174JA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270342	01/10/2007	IL	3.0	3		F	01/10/2007	Varicella vaccine received on 1/04/07 along with influenza vaccine.  Mother reported seeing a couple spots on his chest, back, and diaper area on 1/06/07.  Mother stated rash increased on 1/07/07, but it was totally covering his chest, back, and diaper area on 1/08/07 with itching.  Child was taken to family MD on 1/08/07, and physician verified the rash as varicella.  Treatment was for symptoms:  Tylenol was ordered for temperature, and Benadryl liquid for itching.				Y					U	01/04/2007	01/06/2007	2	None	UNK	UNK	None	No	None			1						1	Pruritus; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U2169NA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0798F~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0270343	01/10/2007	NC	8.0	8		F	01/10/2007	MOTHER THAT APPROXIMATELY 30 MIN. AFTER RECIEVING THE FLU VACCINE THAT SHE HAD SWELLING OF THE LIPS WITH SOME ITCHING.  PT. CAME FOR THE FLU VACCINE AT APPROXIMATELY 4:30 P.M. AND DURING DINNER TIME SWELLING WAS NOTICED.  THE HELATH DEPT. WAS CLOSED BY THEN . PT. DID NOT GO TO THE ED BUT RETURNED TO THE HEALTH DEPT. ON 12/20/06 @ APPROXIMATELY 9:30.  THE SWELLING WAS REPORTED AS DECREASED WHEN SHE ARRIVED- LOWER LIP NO LONGER SWOLLEN BUT UPPER LIP SLIGHTLY SWOLLEN. PT. REPORTED NO ALLERGIES TO EGGS OF MEDICINE ON THE REGISTRATION FORM AND AT THIS RETURN VISIT. BP 98/64 AND WT. 74 LBS. GIVEN BENADRYL 25 MG.				Y					Y	12/19/2006	12/19/2006	0	SEEN ON 12/20/2006; MOTHER REPORTED NOT SYMPTOMS AND NO TREATMENT.	UNK	UNK	NONE	NONE REPORTED	GESTATION AT BIRTH WAS 35 WEEKS			1						1	Face oedema; Rash pruritic	FLU3~SANOFI PASTEUR~U2312AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0270346	01/10/2007	TX	30.0	30		F	01/10/2007	Flu vaccine administered in pm of 1/9/07. In am of 1/10/07 patient was noted to have a 4x4.5 cm swelling on her left arm at the site of injection.  No redness, fever, or other symptoms were noted.  She received a flu vaccine last year with no problems.									Y	01/09/2007	01/10/2007	1	None	UNK	UNK	Dilaudid PCA Oxandrolone 2.5 mg orally daily Famotidine 20 mg orally twice daily Norvasc 5 mg orally daily Catapres TTS-1 patch weekly	Hospitalized with abdominal pain, nausea, vomiting (exacerbation of chronic condition)	Angioneurotic syndrome Hypertension Sulfa drugs, latex, Stadol cause rash			1						1	Injection site swelling	FLU3~SANOFI PASTEUR~U2212AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270348	01/10/2007	IL	78.0	78		F	01/10/2007	78 y/o female who was a resident of a long-term-care facility for 3+ years, rec'd influenza vaccine on 11/4/06.  On aprox 11/17/06 patient's husband stated that the patient became lethargic, refusing food. 11/19/06 patient expired. Patient's huband stated she died of dehydration and kidney failure.	Y	11/19/2006							N	11/04/2006	11/17/2006	13	78 year old female with diabetes.  Client living in long-term-care facility due to complications from several falls resulting in leg-knee fractures and poor recovery.	UNK	UNK	unk	78 y/o in long-term-care facility.  Spoke with infectious control nurse, at the facility who states from record that client temp at time of vaccination 98.7.	Diabetes, immobility-related to previous leg fractures.			1						1	Dehydration; Fracture; Lethargy; Oral intake reduced; Renal failure	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA210AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Results in Death	Influenza
0270351	01/10/2007	WA	40.0	40		F	01/10/2007	Pain both arms including forearms, beginning 3 hours after injection. Arms felt as if them were constricted. She constantly had to rub them.  Felt like she had flu. Pain remains in left deltoid. Pain with ROM any direction.									U	12/14/2006	12/14/2006	0		UNK	UNK	none	none	Codeine, DCN			1						1	Hypokinesia; Influenza like illness; Pain	FLU3~PFIZER\WYETH~71353~1~ID~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0270355	01/11/2007	KS	79.0	79		M	01/05/2007	Left hand swelling and contracture 01/12/07-records received and reviewed for DOS 11-7-07-1-//9-07 C/O contractures mostly of upper extremities. Recent UTI,  PE: exhibits considerable contractures to left wrist and hand as well as right arm.   Ten days after flu shot complained of contractures to wrists, muscle pain in shoulders arms legs and back, headaches. Psychiatric medications increased and rigidity got worse. Medication decreased and contractions in wrists are present. RX with levaquin for UTI. Assessment, unsure if contractures are due to Flu shot no longer believes it is from medications. Plan for neurology consult in near future. Pt moved to another facility.								Y	U	10/26/2006	11/04/2006	9	Calcium levels 9.9-11.3	OTH	OTH	Prilosec, Norvasc, Atenolol, Namenda, Arginaid, Lamictical, Lithium, Abilify. records received 1/12/07:Current medications include lithium, namenda, arginaid, prostat and abilify.	Resolving UTI, Macrobid, Schizophrenia.	HTN, hyperlipidemia, CAD, Carotid artery stenosis, Hypoparathyroidism, schizophrenia, central retinal artery occlusion.  records received 1/12/07:PMH: hypertension, hyperlipidemia, carotid artery stenosis, coronary artery disease, hypoparathyroidism, schizophrenia and central retinal artery occlusion.			1						1		FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69899~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0985F~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0270356	01/11/2007	NC	78.0	78		M	11/27/2006	Took flu shot lat Oct, 1 1/2 - 2 weeks later developed rash dark pink macule all over body, had fever and body aches. 11/27/06 rash still visible, skin reddening no itching. Family Doctor sent for test results, MD doesn't think related to shot. Unsure what it is. Rash is improving.										10/24/2006	11/05/2006	12	Drew blood x 2, Dr called skin biopsy showed virus and lab shows decreased immune system. Electrolytes low per pt.	PUB	PVT	Prevacid	NONE	NKA, bypass surgery, GERD, anxiety.			1						1	Blood electrolytes decreased; Erythema; Immune system disorder; Pain; Pyrexia; Rash; Rash macular; Viral infection	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71355~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0270364	01/11/2007	AZ	2.0	2	.2	F	01/11/2007	Mother stated that patient received large lump at the injection site 24 hours after vaccine. Patient was not in any discomfort. Mother took patient to urgent care where she was treated with allergic reaction with Benadryl which dissolved lump.									Y	12/06/2006	12/07/2006	1		PVT	PVT	NONE	NONE				1						1	Injection site nodule	FLU3~SANOFI PASTEUR~UT2175EA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270366	01/11/2007	IA	8.0	8		F	01/08/2007	Injection Thursday PM. Friday AM-fever and red bump on arm 2 x1 per mother. Took to urgent care Friday pm due to increased redness and large red streak up arm. Started Benadryl and Tylenol. Took child to Urgent care again Saturday. Temp 101F. Started on Cephalexin for 10 days.				Y					Y	01/04/2007	01/05/2007	1		PUB	PUB	NONE	NONE	Allergies-mild products as infant, sulfa			1						1	Erythema; Pyrexia	FLU3~SANOFI PASTEUR~42292AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0795F~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0270367	01/11/2007					U		fatigue, muscle aches, joint aches, appetite loss, body cramps. Currently on medication hold.													Fatigue, muscle aches, joint aches, appetite loss, body cramps. Patient currently on medication hold.	MIL	UNK		NONE	NONE			1						1	Anorexia; Arthralgia; Fatigue; Muscle spasms; Myalgia	ANTH~EMERGENT BIOSOLUTIONS~FAV104~UNK~SC~~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~MERCK & CO. INC.~1083P~UNK~IM~~HEP B (FOREIGN)~1	USA		Influenza
0270369	01/11/2007	SC	60.0	59		F	01/01/2007	Received flu shot arm bled 11/21/06; woke up itching, burning, tongue, mouth swelling 11/22/06; took Benadryl called doc on call told to take Benadryl twice and Pepcid 11/25/06; Went to doctor given Cortisone and Prednisone; back to doctor given shot again and Dexpak; back to doctor told to take Zyrtec and prescribed Triamcinclone cream; Still going to doctor still itching and burning.				Y					N	11/21/2006	11/22/2006	1		PUB	PVT	Lotrel, Zocor, Esterdiol	NONE				1						1	Pruritus; Skin burning sensation; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0270371	01/11/2007	WA	34.0	34		M	12/28/2006	Received nasal flu vaccine on 11/15/06. Later that day developed headache, achiness, lethargy. Next day nasal congestion. Over next few days developed chest congestion, cough. Felt feverish but did not take temp. Coughing produced greenish sputum. Did not see doctor talked to doctor. Symptoms continued on and off for 2 weeks. Recovered when talked to him 12/28/06.									Y	11/15/2006	11/15/2006	0		PUB	PVT		NONE	NONE			1						1	Cough; Headache; Lethargy; Nasal congestion; Pain	FLUN3~MEDIMMUNE VACCINES, INC.~500441P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0270372	01/11/2007	AZ	51.0	50		F	01/18/2007	Scratched arm where vaccine administered during night while asleep. In morning felt pain and more itching. Next day had redness and small blisters over area about the size of a quarter.				Y					Y	10/11/2006	10/12/2006	1	NONE	PUB	PVT	Vitamins	NONE	Deaf			1						1	Erythema; Pain; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~AFLUA201BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0270374	01/11/2007	VA	1.13	1	.1	M	01/08/2007	Urticaria on legs since 1/6/07				Y					U	01/03/2007	01/06/2007	3	NONE	PVT	PVT		NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2260AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0270376	01/11/2007	PR	47.0	47		M	01/01/2007	Headache, still on treatment; anxiety disorder, depression-on treatment; chest pain-on treatment; feet, knee, hand joint painful; eyes difficult, itching, allergy, pain-on treatment.				Y					N	02/26/2003	06/01/2004	461	abnormal ECG, left atrial enlargement, mitral valve regurgitation +1	MIL	MIL		NONE	NONE			1						1	Anxiety; Arthralgia; Chest pain; Depression; Eye irritation; Headache; Hypersensitivity; Laboratory test abnormal; Pain; Pruritus	FLU3~SANOFI PASTEUR~U2284AA~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~UN~HEP B (ENGERIX-B)~1|YF~UNKNOWN MANUFACTURER~~UNK~~UN~YELLOW FEVER (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0270389	01/11/2007	PA	20.0	20		F	01/11/2007	This case was reported by a healthcare professional and described the occurrence of drug exposure during pregnancy in a 20 year old female subject who was vaccinated with Flulaval for prophylaxis. Concurrent medications included Prenatal vitamins and RHO D immune globulin Rhogam. On 9 January 2007 at 13:00 the subject received 1st dose of Flulaval at 0.5ml, intramuscularly in the right arm. The subject was 30 weeks pregnant at the time of vaccination. The Flulaval administered to the subject was given 28 days past the opening of the vial. This was considered to be a medication error. The healthcare professional considered the events were clinically significant 9Or requiring intervention) (OMIC). No adverse events were reported.									U	01/09/2007				PVT	PVT	Prenatal vitamins, Rho (D) immune globulin.				A0635059A	1						1	Medication error; Unintended pregnancy	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F602311~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0270410	01/11/2007	IL	3.0	3		F	01/11/2007	Within 24 hours of receiving the flu shot, patient's left arm became red, hot and very swollen.  Went to emergency room.  Patient was treated with augmentin.  Cellulitis resolved.				Y					Y	01/03/2007	01/04/2007	1	none	UNK	UNK		none	none			1						1	Cellulitis; Injection site erythema; Injection site reaction; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2283AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0270412	01/11/2007	CA	5.0	5		F	01/09/2007	24 hours after vaccine was administered. Mother removed band aid from injection site Right deltoid arm became red, hot to touch, swollen and itchy for three days. Mother noted child had no fever.									Y	12/28/2006	12/29/2006	1	NONE	PUB	PUB	NONE	NONE Healthy child	NONE			1						1	Erythema; Feeling hot; Pruritus; Swelling	DTAP~SANOFI PASTEUR~U1891BA~6~IM~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2281AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0914F~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0270428	01/12/2007	GA	71.0	71		M	11/09/2006	Pt received flu vaccine about 1:30pm 10/26/06. Wife called at 4:45pm states pt having hand tremors and temp 102. Went to home. Tylenol and Benadryl given Per wife. In one hour no improvement. 911 called. Pt transported to hospital ER via stretcher. PT started on IV antibiotics. Admitted to hospital x 5 days.  1/16/07 Received medical records from hospital which reveal patient was admitted to hospital 10/26/06 for neutropenia & fever within 24 hours s/p flu shot.  Heme consult done & treated w/Neupogen & antibiotics.  WBC improved & Neupogen was d/c.  Patient was to continue oral antibiotics &  f/u w/heme & oncologist upon d/c to home on 10/31/06.					Y	5			Y	10/26/2006	10/26/2006	0	LABS: Admit WBC 2.1, H/H 13.2/40, plt 19.  D/C WBC 3.2, 11.1/33.7, plt 32.  Blood c/s neg.	PUB	PVT	NONE		HX Heart disease, Leukemia in remission.  PMH: s/p CABG & cardiomegaly.		GA06058	1						1	Pyrexia; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601411~4~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0270429	01/12/2007	OH	42.0	42		M	01/07/2007	Pneumonia diagnosed and treated by medical center on 20Nov06. had fever for 1 week before treatment. Vaccine administered on 05Nov06. Treated with Moxifloxcin 400 mg.  MR received for 5 day hospital admission due to pneumonia and hypotension.  Pt. developed fever 3 days post Flumist and continue to have fever x 1 week prior to admission.  Treated with abx.  with good response except for residual febrile episodes. Discharged home after 5 days. DX: Pneumonia.				Y	Y	5			Y	11/05/2006	11/08/2006	3	Labs and Diagnostics: CXR shows infiltrates of the right upper and lower lobes.  Opacity in the left lung base representing consolidation. Decreased volume of left lower lobe.  Possible left pleural effusion. Chest CT shows consolidation in both lungs.  No mass or lesion.  Hypodensity right lobe of thyroid. CBC: RBCs, Hct. & Hgb slightly low. Platelet count increased towards end of hospital stay. UA shows trace of blood, Chemistry significant for low BUN, Glucose 128, and low Ca++.	MIL	MIL	NONE		PMH: none noted.  Allergies:  none noted.			1						1	Pneumonia; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500430P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0270433	01/12/2007	NY	17.0	17		F	01/05/2007	Left Deltoid 5cm x 3 1/2 cm circular erythematous tender and warm to touch lesion arm very tender.									Y	01/03/2007	01/03/2007	0		PVT	OTH			Latex allergy.			1						1	Injection site erythema; Injection site warmth; Skin ulcer; Tenderness	FLU3~SANOFI PASTEUR~U2271AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0961F~UNK~~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2116AA~UNK~~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0270434	01/12/2007	NC	1.5	1	.5	M	01/05/2007	Pt received Varivax 12/08/06 pt broke out with chicken pox lesions 12/15/06 with high fever 102-103 Mom was in contact with office several times reports on 12/23/06 pt still with lesions 50+ fever finally broke concerned due to amount of lesions.									Y	12/08/2006	12/15/2006	7	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Pyrexia; Skin ulcer; Viral infection	DTAP~SANOFI PASTEUR~U1751CA~4~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2280AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1051~3~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|VARCEL~MERCK & CO. INC.~0917F~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0270435	01/12/2007	MI	31.0	31		F	12/05/2006	Left arm was very sore, slightly red and swollen. I also had flu type symptoms like, fever, chills. Lasted for 2-3 days.									Y	11/08/2006				OTH	UNK		NONE	NONE			1						1	Chills; Influenza like illness; Injection site erythema; Injection site oedema; Injection site pain; Pyrexia	FLU3~EVANS VACCINES~AFLUA236BA~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0674F~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0270437	01/12/2007	MI	29.0	29		F	12/05/2006	I experienced pain within areas of injection, caused me to lose approximately 50% use of my arm. I also had small splotches develop, red in color dime size.									Y	11/08/2006	11/09/2006	1		OTH	OTH						1						1	Erythema; Injection site pain; Joint range of motion decreased; Rash maculo-papular	FLU3~EVANS VACCINES~AFLUA236BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0674F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0270438	01/12/2007	ID	6.0	6		F	01/08/2007	Received flu shot on 21 Dec 06 mother states next day arm was very red and swollen seen in ER and had local reaction and to TX with Benadryl. SX lasted approx 3 days and resolved. 5 days ago 12 weeks after flu shot, had urticarial rash, red and raised that came and went away with Benadryl, but back with warm, back and since has had sporadic urticaria on back, chest, and arm, no resp SXS.									Y	12/21/2006	12/22/2006	1		MIL	MIL						1						1	Feeling hot; Injection site erythema; Injection site oedema; Rash erythematous; Urticaria	FLU3~SANOFI PASTEUR~U2308AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270439	01/12/2007	TX	3.0	3		M	01/05/2007	Swelling in the left thigh. No pain, no fever. Benadryl given orally.									Y	01/02/2007	01/02/2007	0		PVT	OTH	NONE	NONE	NONE			1						1	Injection site oedema	FLU3~SANOFI PASTEUR~U2279AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270440	01/12/2007	CA	58.0	58		M	01/09/2007	Some problem tried to communicate and report any signs and symptoms for treatment and time of course with the administered and some the provider.									U	11/01/2006			With Graves Disease	OTH	OTH	Propranolol, Propylthhouracil.	NONE	Eye disease, Heart rate problems, rash, itching, runny nose, headache, sore throat, chills.			1						1	Basedow's disease; Unevaluable event	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0270441	01/12/2007	CA	58.0	58		F	01/08/2007	Swelling of tissue around joints at knuckles, wrist, knees, toes, also shins, instep, out step, foot pad extreme pain. Given 30 mg prednisone, reducing at safe level, reduced swelling and pain, under direction of Rheumatologist (referred by doctor). On Medication.										11/30/2006	12/02/2006	2	Blood work, X rays, reveal negative in all but auto immune tag. See attached sheet.	OTH	UNK		NONE	Aspirin.			1						1	Arthralgia; Immune system disorder; Joint swelling; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0270443	01/12/2007	GA	50.0	56		F	12/04/2006	After receiving Pneumonia vaccine on 11/30/06 in left arm became very painful at injection site and has been painful since then. Has been taking Tylenol and it relieves for couple of hours. No redness or temp. Advised to take Benadryl and continue taking Tylenol. Cool cloths as necessary.									U	11/30/2006	11/30/2006	0		PUB	PVT					GA06065	1						1	Injection site pain	FLU3~SANOFI PASTEUR~U2285AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1004P~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0270444	01/12/2007	GA	62.0	62		F	12/11/2006	Pt reported in the Wednesday evening after receiving vaccine she developed chills fever and severe headache lasting thru Sunday, fever 102 on Thursday, fever broke Sat afternoon. headache lasted till Sunday. Saw Dr On Monday. Told no more pneumonia shots.				Y					Y	12/06/2006	12/06/2006	0	NONE	PUB	PVT	Arimidel, Effexor, Bellanide.	NONE	Left breast modified radical mastectomy 2002		GA06064	1						1	Chills; Headache; Pyrexia	FLU3~SANOFI PASTEUR~U2164AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0601F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0270446	01/12/2007	GA	42.0	48		F	11/15/2006	Client stated that she began to have intermittent bouts of palpitations the evening of the vaccine date. SX resolved within 24 hrs. She sought no med advise. She was taking Advil for general malaise and aching during that period.									Y	11/14/2006	11/14/2006	0		OTH	PVT					GA06061	1						1	Malaise; Pain; Palpitations; Malaise; Myalgia; Palpitations	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA216AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|TDAP~SANOFI PASTEUR~C2557AA~1~IM~LA~TDAP (ADACEL)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUR216AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~2|TDAP~SANOFI PASTEUR~C2557AA~1~IM~LA~TDAP (ADACEL)~2	USA		Influenza
0270448	01/12/2007	GA	65.0	65		F	11/09/2006	Patient received Pneumonia vaccine. The next morning arm was sore, redness and swollen area around injection site. Pt states it was warm to touch. She noticed a red streak that went around the arm and into arm pit. She took TYLENOL. Then went to see her doctor. She was started on Prednisone for 3 days.				Y					Y	10/30/2006	10/31/2006	1	NONE	PUB	PVT	NONE	NONE	NONE		GA06059	1						1	Erythema; Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71830~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0620F~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0270449	01/12/2007	GA	50.0	50		F	10/30/2006	Red, swollen, warm to touch, slight tenderness.				Y					Y	10/26/2006	10/26/2006	0		PUB	PUB	Chemotherapy, Dilantin, Synthroid		Breast Cancer		GA06056	1						1	Erythema; Feeling hot; Oedema; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~60718~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0001F~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0270450	01/12/2007	GA	44.0	44		F	11/06/2006	Pain, swelling (4 x size) red blotches rash, injection site to mid lower arm, heat, antibiotics Keflex 500 QID x 10 days, Benadryl 25 QID.				Y						11/02/2006	11/02/2006	0	NONE	PUB	PVT	Singulair, Oxybutynin	NONE	Asthma, MS, Arthritis, Colitis, Hypothyroidism, Hiatal hernia, Lupus, Sjogrens.		GA06055	1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site rash; Rash macular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F061511~7+~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0885F~2~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0270452	01/12/2007	TX	1.02	1	.0	M	12/14/2006	Mother presents with child to get opinion about rash - sudden onset of flat, diffuse, layered rash on cheeks, thighs and trunk - denies fever (says 98.5 R). No change in child's normal behavior - mom says has had 2 days of diarrhea. Recommended doctor visit.				Y					Y	11/30/2006	12/14/2006	14	None available. Mom says child ok now.	PUB	PUB	NONE	NONE	Lactose intolerant		TX06082	1						1	Diarrhoea; Rash	DTAP~SANOFI PASTEUR~U1891BA~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2191CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0651F~1~IM~RL~HEP A (VAQTA)~1|HIBV~SANOFI PASTEUR~UE928AA~3~IM~LL~HIB (ACTHIB)~1|MMRV~MERCK & CO. INC.~0827F~1~SC~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08683F~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0270453	01/12/2007	MD	59.0	59		F	01/12/2007	1. Severe pain at injection site, immediately after injection. 2. Terrible taste in mouth. 3. Rubbery legs. Patient  sent to ER for evaluation. Results of ER evaluation not known. Patient still had symptoms on 12/05/2006.				Y					U	12/01/2006	12/01/2006	0	NONE	PUB	PUB	Evista for osteoporosis	NONE	Sulfa and Penicillin allergies, osteoporosis			1						1	Asthenia; Dysgeusia; Injection site pain	FLU3~SANOFI PASTEUR~U2247AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0270467	01/12/2007	WI	0.18	0	.2	F	01/12/2007	Gave Preservative-Free Fluzone to child younger than 6 months of age thinking the patient had to be 6 weeks to receive the flu vaccine. Observed child about 45 minutes following the shot and no allergice reaction had occurred. Called mom the following day (today) and mom has not noticed any abnormalities in her daughter such as difficulty breathing or redness/swelling at the injection site.									Y	01/11/2007				UNK	UNK						1						1	Medication error	FLU3~SANOFI PASTEUR~U2220AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270469	01/12/2007	MI	97.0	96		F	01/12/2007	Immediately after administraton of vaccine, patient complained of pain in arm. Continued to complain of pain through the day. Took to Dr. multiple times for follow-up regarding c/o pain in arm. Has swelling in shoulder still. Pain radiates to shoulder and down arm. Has started physical therapy.									N	10/09/2006	10/09/2006	0		UNK	UNK		None known				1						1	Pain; Swelling	FLU3~SANOFI PASTEUR~U2256AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270473	01/12/2007	RI	64.0	64		F	01/12/2007	Employee received vaccine at approximately 7:15 Am on 1/5/07. Employee went home after shift.  As she stated, around 11AM her throat started swelling up, she had difficulty swallowing, and lips started to swell.  She called rescue, and was taken to local ER				Y					Y	01/05/2007	01/05/2007	0	Employee stated, she was given IV's, unsure of exact med.  Was also stabilized and given prescription for Hydroxyzine hcl 25 mg., Methylpred pak 4 mg.and Metoclopram 10 mg.	UNK	UNK	none	none	none	rash, fever~Tetanus Toxoid (no brand name)~0~0.00~In Patient		1						1	Dysphagia; Pharyngeal oedema; Swelling face	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601211~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0270474	01/12/2007	NC	1.29	1	.3	M	01/12/2007	Day after DTaP  vaccines given patient presented to clinic with a cellulitis medial to the injection site									U	01/09/2007	01/10/2007	1		UNK	UNK	none	none	none			1						1	Cellulitis; Injection site reaction	DTAP~SANOFI PASTEUR~U1985CA~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2244AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0403F~4~IM~LL~HIB (PEDVAXHIB)~1	USA		Influenza
0270478	01/12/2007	TX	37.0	37		F	01/12/2007	Patient received a flu and pneumonia shot on 12/19/06. The patient has lupus. The patient developed left hand and right leg numbness immediately after the injections were given. 02/23/07-records received and reviewed for DOS 12/18-12/26/06 DC DX: meningitis, staphylococcus coagulase negative lupus induced monoeuritis multiplex congestive heart failure exacerbation; two dimensional echo showed global hypokinesia with concentric left ventricular hypertrophy pulmonary hypertension chronic anemia and B12 deficiency diabetes mellitus hypertension SLE Presented with shortness of breath and bilateral lower extremity swelling for three days.  PE: CNS:generalized decrease in strength 4/5 all extremities. Sensation decreased in left lower extremity. Plantars are downgoing.					Y	8	Y		Y	12/19/2006	12/19/2006	0	WBC 12.8, BNP 2259 CXR cardiomegaly questionable right sided infiltrate EKG: Normal sinus rhythm. US DVT negative CSF AFB smear/culture negative. MRI cervical spine: cervical stenosis, probably due to degenerative changes and cerivcal lordosis from C3 to C4 and C5 to C6, left neural foraminal narrowing from C3 to C4. Joint hypertrophy, mild neural foraminal narrowing C4 to C5 bilaterally. No gross disc herniation. MRI brain: punctate focus of increasing signal in the left aspect of the midbrain may represent an artefact or a recent infarction. Chronic lunar infarct involving the right cortex in right perventricular region.	MIL	PUB	Tracleer Plaquinil	482.83   PNEUMONIA DUE TO GRAM-NEG        428.0    CONGESTIVE HEART FAILURE,        710.0    SYST LUPUS ERYTHEMATOSIS         320.3    STAPHYLOCOCC MENINGITIS          517.8    LUNG INVOLV IN OTH DIS           285.29   ANEMIA-OTHER CHRONIC DIS         266.2    B-COMPLEX DEFIC NEC              250.60   DIABETES W/NEURO MANIF TY        357.2    NEUROPATHY IN DIABETES           355.9    MONONEURITIS NOS	Lupus PMH: SLE, lupus induced hypertension, diabetes, anemia of chronic disease with pulmonary hypertension.			1						1	Asthenia; Cardiac failure congestive; Condition aggravated; Hypoaesthesia; Immediate post-injection reaction; Meningitis; Mononeuritis; Mononeuropathy multiplex; Sensory loss	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA231BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~9722106~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0270480	01/12/2007	PA	1.61	1	.6	M	01/12/2007	High Fever and coughing 02/09/07-records received and reviewed for DOS 01/01-01/05/07 DC DX: acute bronchiolitis/RAD viral syndrome possible reaction to DTAP and flu shot.  Rhinosinusitis Seen in ER for hyperpyrexia. Temp in ER 106 with cough and wheezing. Started one week prior to admission. Cold without fever. Received vaccines 4 days prior admission. One and one half days later developed fever to 103-104. Seen in ER on 12/31/06, treated with Motrin, Tylenol and cough medication and sent home. Temperature spiked to 105 prior to admission. No seizure. No meningeal signs. PE: Temp on admission 98.3. WNL except for Throat injected, tonsils enlarged, nose clear mucus.				Y	Y	5			U	12/28/2006	12/29/2006	1	CXR: no active disease in chest. Influenza A antigen negative RSV negative Anion gap 14.0 Gran %75.8, lymph %14.8, mono %9.4 Glucose 109 CRP 31.7 Strep culture negative. Blood culture negative.	UNK	UNK	abrutrol and others	he had a viral infection	none			1						1	Cough; Pyrexia	DTP~UNKNOWN MANUFACTURER~unknown~6~IM~LL~DTP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0270505	01/12/2007	VA	56.0	56		F	01/12/2007	On 1-3-07 pneumovax and influenza vaccine administered. On 1-4-07 patient started with fever and headache. Soreness and reddness in arm began 1-6-07. Reddness and swelling extended from left shoulder to elbow.  Patient seen on 1-8-07 by Dr. Patient diagnosed with pneumovax reaction with secondary cellulitis. Keflex 500 tid given. Seen by Dr. on 1-12-07 - patient has decreased redness and cellulitis. Patient under care of Dr.				Y						01/03/2007	01/04/2007	1		PUB	PVT	Synthroid, Cardizem, Diovan, Nexium, Allegra, Nitroglycerin, Effexor, Ativan, Fibermax	NONE	Hypertension, Irritable Bowel, Hyperthyroidism, Anxiety			1						1	Cellulitis; Erythema; Headache; Injection site reaction; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2244AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0352F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0270507	01/12/2007	OH		2	.2	M	01/12/2007	at thigh with 4cm x 7.5 cm erythema and induration 7.2cm x 4 cm at Hep A site.									Y	01/10/2007	01/12/2007	2	NONE	PVT	UNK		NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site erythema; Injection site induration; Injection site inflammation	DTAP~SANOFI PASTEUR~C2405AA~4~~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2176JA~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0804F~1~~LL~HEP A (VAQTA)~1|PNC~PFIZER\WYETH~B08670F~4~~RA~PNEUMO (PREVNAR)~1|DTAP~SANOFI PASTEUR~C2405AA~4~UN~UN~DTAP (DAPTACEL)~2|FLU3~SANOFI PASTEUR~UT21763A~2~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~MERCK & CO. INC.~0804F~1~UN~UN~HEP A (VAQTA)~2|PNC~PFIZER\WYETH~B08670F1~4~UN~UN~PNEUMO (PREVNAR)~2	USA		Influenza
0270508	01/12/2007	KY	1.0	1	.0	M	01/12/2007	fever to 101 x 2 days, decreased appetite-loose stool, 3 vesicular lesions-back trunk-1 hard									U	01/02/2007	01/11/2007	9		PVT	PVT						1						1	Decreased appetite; Diarrhoea; Pyrexia; Rash vesicular; Anorexia; Body temperature; Diarrhoea; Pyrexia; Rash vesicular; Varicella; Varicella post vaccine	FLU3~SANOFI PASTEUR~UT2174LA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1213F~1~IM~RL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~1386F~1~SC~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08670K~4~IM~LL~PNEUMO (PREVNAR)~1|FLU3~SANOFI PASTEUR~UT2174LA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~MERCK & CO. INC.~656497/1213F~1~IM~~HEP A (VAQTA)~2|MMRV~MERCK & CO. INC.~655847/1386F~1~SC~~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~2|PNC~PFIZER\WYETH~B08670K~4~IM~~PNEUMO (PREVNAR)~2	USA		Influenza
0270509	01/12/2007	AZ	4.0	4		M	11/10/2006	His arm became swollen, red and warm.  Mother brought child to the doctor with a fever (we have attempted to contact the mother weekly for further information and have been unsuccessful.				Y					Y	10/24/2006	10/24/2006	0		PUB	UNK						1						1	Erythema; Feeling hot; Oedema peripheral; Pyrexia	FLU3~SANOFI PASTEUR~U2193AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0270517	01/12/2007	PA	1.23	1	.2	F	01/12/2007	Pt given FluMist as ordered in clinic order form. Child had no adverse affects. Parents vomited 1/2 hr.									Y	01/12/2007			NONE	PVT	UNK		NONE				1						1	Unevaluable event	DTAP~SANOFI PASTEUR~C23432AD~3~~LA~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1|HBHEPB~MERCK & CO. INC.~1073F~3~~RA~HIB + HEP B (COMVAX)~1|IPV~SANOFI PASTEUR~Z0306~3~~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0234F~UNK~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0270482	01/13/2007	GA	68.0	68		F	01/13/2007	Pt recieved the ful vaccine in the left deltoid on Wednesday at 12:40 p.m.  On Saturday the patients spouse called and stated his wife was unable to get out of the bed, she has vertigo and vomiting.  He denies any local reaction to the vaccine.									U	01/10/2007	01/13/2007	3	none	UNK	UNK	synthroid	none	hypothyroid			1						1	Vertigo; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71356~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0270488	01/15/2007	TX	9.0	9		F	01/15/2007	Hematoma, firmness, warmth Motrin, warm compresses				Y					U	01/13/2007	01/13/2007	0	non	UNK	UNK	none	none	none			1						1	Feeling hot; Haematoma	FLU3~SANOFI PASTEUR~u2262aa~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1148f~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0270489	01/15/2007	TX	9.0	9		M	01/15/2007	Hematoma, firmness, warmth Warm compresses, Motrin				Y					U	01/13/2007	01/13/2007	0	none	UNK	UNK	none	none	none			1						1	Feeling hot; Haematoma	FLU3~SANOFI PASTEUR~u2262aa~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1148f~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0270490	01/15/2007	WA	71.0	71		F	01/15/2007	We have a patient who swears that she is now in Hospital (january 2007) for Bilateral Lobal Pneumonia due to her recieving Fluzone from us on 10/25/2006.  She has always gotten her yearly flu shot with no complications, but felt tired and/or lethargic weeks after this years vaccination.  Her daughter relayed all this info to me.  1/26/07 Received medical records from hospital which reveal patient experienced respiratory distress & was admitted 1/8-1/11/07.  Treated w/antibiotics, bronchodilators & steroids.  Improved significantly & was d/c on tapering prednisone & close f/u. FINAL DX: Multilobar pneumonia in a smoker; possible bronchogenic neoplasm which will be worked up as outpatient; hyponatremia; COPD; multifocal atrial tachycardia, short duration; tobacco abuse; & hyperlipidemia.					Y	1			Y	10/25/2006	01/10/2007	77	na LABS: CXR showed RML & left perihilar infiltrates.  CT pulm angiogram showed extensive bilateral pulmonary consolidation with probable underlying interstitial lund disease.  EKG showed runs of supraventricular tachycardia & AV multifocal atrial tachycardia.  WBC 31,000. Na 125.  Blood cultures neg. Na remained in 120s despite treatment.	UNK	UNK	unknown	no	unknown COPD; continues abuse smoke; hyperlipidemia			1						1	Angiogram pulmonary abnormal; Atrial tachycardia; Blood culture negative; Blood sodium decreased; Chest X-ray abnormal; Chronic obstructive pulmonary disease; Electrocardiogram abnormal; Fatigue; Hyponatraemia; Lethargy; No reaction on previous exposure to drug; Pneumonia; Supraventricular tachycardia; Tobacco user; White blood cell count increased; Asthenia; Back pain; Chest X-ray abnormal; Cough; Ear pain; Failure to thrive; Headache; Hypersomnia; Pneumonia	FLU3~SANOFI PASTEUR~U2218DA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~G0008~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0270503	01/15/2007	AZ	65.0	65		F	01/15/2007	Received flu vaccine on 11/2/06. She presented to our clinic on 12/7/06 complained of persistent pain to injection site. Denies swelling, redness to injection site. She presented to primary care physician on 1/10/07 because of persistent arm pain, difficulty combing hair and putting bra on. She returned to our clinic on 1/11/07 to report continued Left arm pain.									U	11/02/2006	12/07/2006	35		PVT	PVT	Actonel	NONE	rule out sepsis-negative			1						1	Injection site erythema; Injection site pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA206AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0268910	01/16/2007	AR	52.0			F	01/03/2007	Tingling and numbness in hands, legs, face. Double vision. Imbalance. (Please see discharge summary attached). Discharge diagnosis: Miller-Fisher syndrome. History: Patient is a 52 year old lady who had a flu shot on Friday and started to have lower extremity weakness started the next day of the flu shot and she fell in the bathroom withou losing her consciousness. She has noticed increasing weakness in her legs over two days, and she also reported numbness in the lower extremities that started distally and gradually spread upward. The patient went to an outside hospital where a CT scan of the head was done and reported as normal, and the patient was discharged from the ER there. Then the patient noticed that the numbness was increasing, and she noted that her hands became weak and she was dropping things from her hands. The patient also started to have a change in her voice. Her voice became of a nasal tone althought she has an unclear voice to start with, but she said that her voice on presentation was much different then it used to be. The patient also gave a history of double vision.				Y	Y	11			Y	12/08/2006	12/09/2006	1		OTH	OTH	MOBIC for bursitis		Borderline high blood pressure; allergic to penicillin			1						3	Diplopia; Hypoaesthesia; Miller Fisher syndrome; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~415882~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~3	USA	Hospitalisation	Influenza
0270527	01/16/2007	VA	42.0	42		F	01/08/2007	On 12 Oct 2006, two days after receiving FluMist therapy, a 42 year old female nurse patient experienced, feeling sick, fever like symptoms, thick mucous, congestion, diarrhea, stomach pain, joint pain and teeth pain. The sick feeling, fever like symptoms, diarrhea and stomach pain resolved on 16 Oct 2006. On 16 Oct 2006, six days after receiving Flumist therapy, the patient experienced coughing and bronchitis. The congestion began to manifest itself at night as well. These events persisted for two weeks. On 09 Nov 2006, the patient was seen by her primary care physician and described the events. No X rays, cultures or labs were taken. The patient was placed on Ketek and Medrol dose pak  therapy. The events of joint pain, teeth pain, coughing, thick mucous, congestion at night and bronchitis resolved on 16 Nov 2006. The patient indicated that she was able to breathe freely and that her lungs were clear. On 25 Nov 2006, 46 days after receiving FluMist therapy, the patient experienced abdominal pain, which progressed to blood diarrhea. A computed tomography scan on 25 Nov 2006 showed an enlarged right, colon, but a mal closure could not be ruled out. On 30 Nov 2006, 51 days after receiving FluMist therapy, the patient was hospitalized for bloody diarrhea. The initial clinical impression was clostridium difficile. The patient was treated with Dilaudid, hydration therapy and clear liquids. The patient indicated that she received no antibiotic therapy while hospitalized. She was discharged on 03 Dec 2006. The events of abdominal pain, blood diarrhea and bacterial colitis were resolved at that time. The patient indicated that the events of abdominal pain, bloody diarrhea and bacterial colitis were most likely due to Ketek therapy. No reporter causality as it related to FluMist therapy was provided.					Y				Y	10/10/2006	10/12/2006	2	CT Scan 11/25/06 Enlarged right colon.	MIL	MIL	Ketek; Medrol Dose Pak				MEDI0005046	1						1	Abdominal pain; Abdominal pain upper; Arthralgia; Bacterial infection; Bronchitis; Colitis; Cough; Diarrhoea; Diarrhoea haemorrhagic; Laboratory test abnormal; Malaise; Nasal congestion; Oral pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500429P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0270538	01/16/2007	KY				M	01/16/2007	This case was reported by a healthcare professional and described the occurrence of hearing loss in a male subject aged between 40 and 49 years old who was vaccinated with Fluarix for prophylaxis. The subject's medical history included thyroidectomy. Concurrent medications included Synthroid and Aspirin. The subject had on adverse events following receipt of prior immunizations of influenza virus vaccine. On 18 October 2006 the subject received unspecified dose of Fluarix in the left arm. On 25 November 2006, 38 days after vaccination with Fluarix, the subject experienced hearing loss in the right ear. On 30 November 2006, the subject was seen by a physician. An audiogram was performed on 30 November 2006 and revealed vestibular labyrinthitis. The reporter stated that the vestibular labyrinthitis was probably viral. The subject was treated with steroid and anti viral medication (Antiviral). At the time of a follow up appointment with a physician on 13 December 2006, the events had improved. The healthcare professional considered the events to possibly be related to vaccination with Fluarix. Comment: hearing loss was assessed as medically serious by manufacturer.				Y					N	10/18/2006	11/25/2006	38	30 November 2006 audiogram revealed vestibular labyrinthitis.	PVT	PVT	Thyroxine Sodium, Aspirin	UNK	Thyroidectomy-The subject's concurrent conditions were not reported.		A0635554A	1						1	Deafness; Deafness unilateral; Labyrinthitis; Vestibular disorder; Viral labyrinthitis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA218AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0270542	01/16/2007	NE	1.04	1	.0	F	01/09/2007	Patient began with rash four to five days ago and continues to become more prominent and patient has all over entire body.										12/26/2006	01/03/2007	8	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Rash generalised	FLU3~SANOFI PASTEUR~UT2174LA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0804F~1~IM~RL~HEP A (VAQTA)~1|MMR~MERCK & CO. INC.~0632F~1~SC~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|VARCEL~MERCK & CO. INC.~0911F~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0270543	01/16/2007	AZ	75.0	75		F	01/10/2007	Right arm muscle, shot given. Mild at first. It settled in the muscle on the underside of the arm. Became very painful. Especially 1st thing in am. Went to doctor 12-13-06. Prescribed Ibuprofen 800 mg, didn't help. Prescribed Sanindoc 200 mg, did not help December 22 December 28 Methocarban 500 mg no help and then Hydrocol Apap 5 500 mg. On 1/2/07 went to orthopedic physician. X-rays showed nothing. Gave me a cortisone shot. It worked and pain went away. Will see him again 1/30/07. He could not tell me if the flu shot was to blame. I called the above service and asked what was in my shot. Have not heard back still would like to know. Do I get another shot next fall?									Y	10/28/2006	11/01/2006	4		OTH	OTH						1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2213AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270544	01/16/2007	CA	4.0	4		M	01/06/2007	No fever, Right thigh red inflammation. Darker in color where shot was given, bruise in area. (W) 7in x (L) 6in. Consulted with doctor. Benadryl 12.5 mg 15ml tsp by mouth every six hours.  Follow-up - vaccine manufacturer provided.									U	01/04/2007	01/05/2007	1		PUB	OTH						1						1	Erythema; Inflammation; Injection site bruising; Injection site discolouration	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B035AA~UNK~~RL~DTAP (INFANRIX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71032~UNK~~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~MERCK & CO. INC.~HAVB139BO~UNK~~LL~HEP A (VAQTA)~1|PNC~PFIZER\WYETH~B08635C~UNK~~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0270545	01/16/2007	NE	1.25	1	.3	M	01/10/2007	Injection site on Left leg red. Redness is 4 cm x 3cm with a 1cm induration.									Y	01/03/2007	01/04/2007	1	NONE	PUB	OTH	NONE	NONE	NONE			1						1	Injection site erythema; Injection site induration	DTAP~GLAXOSMITHKLINE BIOLOGICALS~C2254AA~UNK~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2191AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08657A~UNK~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0270546	01/16/2007	IL	79.0	79		F		Had a cold the day I received my Flu and Pneumonia shots but, generally I was in good condition. Next day 10/26/2006 I developed the shingles and had to go immediate Care and my primary physician out on Valtrex 21 pills and Triaminolone. No blisters at this time 1/2/2007. Can you get the shingles again?				Y					U	10/25/2006	10/26/2006	1		OTH	OTH			Doctor name given primary.			1						1	Herpes zoster; Herpes zoster	FLU3~SANOFI PASTEUR~U2188AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0391F~UNK~~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U2188A~2~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0391F~2~UN~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0270547	01/16/2007	AL	12.0	11		M	01/08/2007	Patient developed 6x6.5 cm area of redness around injection site, left arm.				Y					Y	01/05/2007	01/07/2007	2	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U2258AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2136AA~1~~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2631AA~6~~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0270548	01/16/2007	KY	20.0	19		F	01/08/2007	Four days following the Gardasil vaccine, the patient developed a rash all over her body that was itchy and skin colored. It seemed to be worse on the arm of injections site. The patient received an antihistamine and cortisone creme.									Y	11/22/2006	11/26/2006	4	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Pruritus; Rash generalised	FLU3~SANOFI PASTEUR~U2241AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0868F~1~IM~RA~HPV (GARDASIL)~1	USA		Influenza
0270549	01/16/2007	TX	6.0	6		F	12/29/2006	generalized macular papular rash body and face. Benadryl 11/2 tsp by mouth every 10 hours for 5 days.										12/28/2006	12/29/2006	1		PVT	PUB	Singular, Topmol	NONE	NONE	rash~Influenza (Seasonal) (Fluzone)~~6.00~In Patient		1						1	Rash generalised; Rash papular	FLU3~SANOFI PASTEUR~U2245AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270550	01/16/2007	MN	1.02	1	.0	F	01/09/2007	Child reportedly had low grade fevers day after vaccines and received ibuprofen. About 48 hours after vaccines fever spiked to 105 and child had seizure lasting about 2 minutes, post-ictal about 15 minutes. Transported by ambulance to emergency department. MR received from hospital visit of 01/07/2007 for c/o febrile seizure 2 days post vax. HPI: Child began running fever day of vax.  Parents using Motrin but underdosing for weight.  Day of seizure child went limp and then began jerking and this lasted about a minute.  In ER temp was 105.1'F.  Dropped to 102.5F with Tylenol and Motrin. She was D/Cd home from ER on Tylenol and Motrin for fever control. Discharge DX: Febrile Seizure.				Y					Y	01/05/2007	01/07/2007	2	Normal complete blood count, chemistry panel, magnesium and UA. Labs And Diagnostics: Labs unremarkable. CXR normal.	PVT	PVT	NONE Meds: Motrin.	NONE	NONE PMH: none.  Allergies: none.			1						1	Convulsion; Full blood count normal; Pyrexia	FLU3~SANOFI PASTEUR~U2282AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0999F~3~IM~RL~HIB + HEP B (COMVAX)~1|HEPA~MERCK & CO. INC.~1209F~1~IM~LL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~1122F~1~SC~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0270551	01/16/2007	WV	25.0	24		F	01/09/2007	Patient received Hep A, Hep B in left arm, flu in right arm. She stated in phone call to me she had increase pain in right arm, mouth soreness, mouth bleeding when brushing teeth that night and AM. She states a slight dizzy spell upon rising Sunday morning that lasted a few minutes.				Y						01/06/2007	01/06/2007	0		MIL	MIL		NONE				1						1	Dizziness; Mouth haemorrhage; Oral pain; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA244AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB360CA~3~IM~LA~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB109CA~2~IM~LA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0270552	01/16/2007	NY	67.0	66		F	12/18/2006	One hour after shot ached all over, chills, fever 103. Saw medical doctor next day 12/15 blood work ordered and prednisone ordered for 5 days. No reaction at injection site. Experiencing chest pain and back pain. Tylenol as needed to decrease pain. Saturday 12/16 face broke out in rash. Medical doctor contacted 12/17 continue prednisone call if problems persist.				Y						12/14/2006	12/14/2006	0	Complete blood count/differential Flx MN, Man diff, ESR	PUB	PUB	Lipitor	NONE	Sulpha			1						1	Back pain; Chest pain; Chills; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601711~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0270553	01/16/2007	FL	57.0	56		M	01/10/2007	Employee complained of pain, numbness in left arm within days of getting flu vaccine. Has been treated with physical therapy, anti inflammatories. Has orthopedic referral pending.									N	10/16/2006	10/17/2006	1	NONE	PVT	OTH		NONE	NONE			1						1	Hypoaesthesia; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA208BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0270571	01/16/2007	FL	70.0	70		F	01/16/2007	Client had pain, redness, warmth, whelps, swelling, and itching at the injection site.  Client had a headache and weakness in both legs.									Y	01/12/2007	01/12/2007	0	None.	PUB	PVT	Only vitamins.	None.	Allergic to codeine and penicillin.			1						1	Asthenia; Headache; Injection site erythema; Injection site pain; Injection site pruritus; Injection site swelling; Injection site warmth; Urticaria	FLU3~SANOFI PASTEUR~U2285AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0486F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0270576	01/16/2007	GA	47.0	47		M	01/16/2007	47 YO developed erythematous, pruritic rash on eyelids and face after receiving flu vaccine on 11/21/06.  He had received flu vaccination previously without complications or reaction.  The rash was treated with PO diphenhydramine.									Y	11/20/2006	11/21/2006	1	None	UNK	UNK	1.  Omeprazole 40 mg BID 2.  Atrovent inh 2 puffs QID 3.  Guaifenesin syrup (has not taken yet) 4.  Felodipine 10 mg QD 5.  Enalapril 20 mg BID 6.  Diclofenac 100 mg BID with food 7.  Quetiapine 50 mg BID plus 200 mg QHS 8.  Mirtazapine 90	None other than chronic conditions	1.  COPD and asthma--PFTs 2/01 FVC 2.97, FEV1 2.19.  5 inpatient admits to BVAMC  since 1/02 for COPD exacerbation (last 1/04)  2.  Sleep apnea on CPAP 12 3.  Hypertension  4.  PTSD 5.  History of alcohol abuse 6.  History of migraines  7.  Depression  8.  Abnormal sestamibi in 10/02 with mild scar in RCA, mild stress and resting  left ventricular dysfunction and dilation.  Rest EF was 47%.  9.  Erectile d/o 10. Septoplasty and turbinoplasty, 9/05 11. Restless leg syndrome 12. HLD--lipid panel 7/06:  TC 167, TG 80, HDL 56, LDL 95 13. Allergic rhinits, sinusitis  ALL: 1.  Codeine--n/v 2.  Morphine--HA			1						1	Purpura; Rash; Rash erythematous	FLU3~SANOFI PASTEUR~U2258AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270578	01/16/2007	CA	1.14	1	.1	F	01/16/2007	Patient received vaccines on 12/27/2006. On 12/29/2006, patient reportedly experienced a simple febrile seizure at home with fever 105.2 rectal documented. Patient defervesced with acetaminophen and ibuprofen. No subsequent seizures were reported on follow-up visit on 1/8/2007 at which time patient was seen for cough/otitis media. 01/25/07-records received and reviewed for DOS 12/29/06- DC DX: Febrile illness, upper respiratory infection, Viral Syndrome HX: Seen at office with temperature of 105 and had seizure, lasted 30 seconds. Acted normal afterwards. Runny nose and slight cough. IN ER temperature 100.  PE: WNL, positive for rhinorrhea. Impression:uncomplicated febrile seizure, source for the fever is upper respiratory type symptoms.				Y					Y	12/27/2006	12/29/2006	2	12/29/2006 catheterized urine culture was negative for infection.	UNK	UNK		None	None			1						1	Febrile convulsion; Pyrexia	FLU3~SANOFI PASTEUR~u220bb~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0401f~4~IM~RA~HIB (PEDVAXHIB)~1|MMR~UNKNOWN MANUFACTURER~0632f~1~SC~LA~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~1138f~1~SC~RA~VARICELLA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0270582	01/16/2007	FL	49.0	49		F	01/16/2007	Five minutes after receiving vaccine was at pharmacy when had chest pain, like pinching on chest and was a bit out of breath. Went back to doctor's office and was given a Nexium - although patient comments that it was not acid reflux and lay down for 20 minutes. Felt better after 1 hour over the weekend pinching will come back every once in a while. Recovered by Monday.				Y					Y	12/01/2006	12/01/2006	0		PVT	PUB	FLONASE, ZYRTEC, PERCOCET, RESTRIL (or AMBIEN), REGLAN, FLEXERIL, DIOVAN, PREVACID, XANAX (or ATIVAN)	NONE	Fibromyalgia, Osteoarthritis, Hepatitis C in 2003	flu-like symptoms~Influenza (Seasonal) (no brand name)~~40.00~In Patient		1						1	Chest pain; Dyspnoea; Chest pain	FLU3~SANOFI PASTEUR~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0270605	01/17/2007	MA	70.0	69		F	01/09/2007	On 11/16/06, the patient was given a flu shot at a clinic. She pointed to an area of the lower deltoid where she said the shot was given. She had family visit her after Christmas and was sleeping on the sofa. She developed pain and redness of left shoulder and was seen by an orthopedic surgeon, who did a left shoulder X ray which showed tendonitis. Dr said it was due to her sleeping on a sofa.				Y					Y	11/16/2006			L shoulder X ray done 01/10/07	PUB	PUB	Pamelor, Zoloft, Cardizem.		Penicillin, Hypertension, depression.		MA0614	1						1	Erythema; Musculoskeletal pain; Tendonitis	FLU3~SANOFI PASTEUR~U2279AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0270608	01/17/2007	WA	1.53	1	.5	M	01/05/2007	Right thigh red, swollen, warm, RX'd Keflex									Y	01/03/2007	01/04/2007	1		PVT	PUB					WA072158	1						1	Injection site erythema; Injection site oedema; Injection site warmth	DTAP~SANOFI PASTEUR~C2649AA~4~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2219AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0440F~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0270609	01/17/2007	HI	1.26	1	.3	F	01/12/2007	Brief febrile convulsion within 12 hours of receiving Dtap, Hib, Prevnar, and Flu vaccine. 1/29/07  Received medical records from provider which included ER record.  Seen in ER on 1/10/07 for mouth twitching, eye twitching & rolling back lasting for approx 1 min & followed by a period of quietness.  Had cold/cough for few days prior to receiving vax & was running a fever of unknown value.  Temp in ER was 101.  Tx w/antipyretic & d/c to f/u by PCP next day.  At PCP office, 1/11 & no further fever or seizure activity noted. LABS: WBC 16.7. FINAL DX: Febrile seizure.				Y					Y	01/10/2007	01/10/2007	0		PVT	UNK		Cough & cold symptoms with fever.	NONE			1						1	Febrile convulsion	DTAP~SANOFI PASTEUR~C2521AA~4~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2174GA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE962AF~4~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B08683C~4~IM~RA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0270626	01/17/2007	OH	49.0	49		F	01/17/2007	Pt received inactivated Influenza vaccine, 0.5ml IM in the left deltoid at 1410 on 16 Jan 2007.  At approximately 1508, the pt came to the front clinic desk c/o wheezing/coughing.  I quickly notified Dr who came out and brought her to the back treatment room.  He listened to her lungs, thten requested us to perform a PFT on the patient.  After the PFT's were accomplished, she was administered a nebulizer treatment of Albuterol 5mg and Atrovent 0.05mg.  Following completion of the neb tx, Dr listened to her lungs again, and requested us to repeat the PFT.  After those results came up, the patient was still complaining of cough. Dr asked her several times if she had any other symptoms other than a cough, and this time she said she was having some chest tightness.  Dr ordered me to administer 0.3mg of Epinephrine IM.  I administered the Epi at 1542.  Following the dose of Epi we obtained vital signs.  After the second set of vital signs, the patient was given 40mg of Prednisone to decrease the chances of a latent phase reoccurrence of the reaction.  We observed the patient for an hour, she continued to improve, then when Dr felt confident enough about her condition, she was released to her husband who drove her home.									Y	01/16/2007	01/16/2007	0		MIL	MIL		none	Allergic to Amoxicillin, sulfa drugs and tetracycline.  Significant chronic hx of asthma, ARD, SAR.			1						1	Chest discomfort; Cough; Wheezing	FLU3~SANOFI PASTEUR~U2310AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270632	01/17/2007	NV	0.5	0	.5	F	01/17/2007	pt received vaccine at 1340, mom noticed hives at 1415, returned to clinic, seen by md at 1515, benadryl given at 1515, pt observed until 1600, reddness and elevation lessened, no further hives noted									Y	01/17/2007	01/17/2007	0		PUB	PUB	NONE	NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~62169pa~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270633	01/17/2007	SC	53.0	53		F	01/17/2007	Gullian [[name]] Syndrome, Partial paralysis, pain about 2-3 weeks after influenza vaccination patient received Plasmapheresis treatment.  2/5/07 Received medical records from hospital which reveal that patient experienced progressive weakness of her [[name]]s & tingling of the toes over a 4 week period along with weakness of the hands, bladder urgency & low back pain.  Admitted 12/18/2002-12/23/2002.  On exam she had [[name]] weakness & absent ankle jerk reflexes.   Tx w/plasmaphoresis x 4.  Improved & was d/c to home with f/u by neuro.   FINAL DX: Guillain [[name]] syndrome; hypothyroidism; HTN; & lumbago.			Y		Y	5		Y	N	12/06/2002	12/18/2002	12	LABS: MRI done week prior to admit was WNL. LP was neg.  EMG done at neuro office showed decreased amplitude in right peroneal nerve.	UNK	UNK			PMH: HTN; Graves dx; & lumbago.			1						1	Guillain-Barre syndrome; Pain; Paralysis; Plasmapheresis	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0270769	01/18/2007	IL	2.0	2	.0	F	01/11/2007	Patient was inoculated 12-22-06 child developed ataxia 1-10-07 seen at hospital ER and admitted for work-up. 03/01/07-records received from PCP for DOS 12/21/06-02/06/07 Hospitalized 01/10-01/12/07-DC DX:Lack of coordination. Late effects of vrial encephalitis. PCP note 2/6/07-all diagnostic tests negative, and conclusion was post viral cerebellitis. On visit 2/6/07-alter, no ataxia. Stye on left eye. Well visit 12/21/06-WNL No one ever suspected that her condition was caused by vaccination, event was reported due to occuring within 45 days of a vaccination. Followup 3/30/2010 We never thought the vaccine caused her problem but we made the report because they symptoms presented within 45 days of immunization. She is ok and did get a 2nd flu shot without incident.				Y	Y	2			Y	12/22/2006	01/10/2007	19	Work-up for ataxia so far has included negative head CT, toxicology pending, consultation peds neurology.	PVT	PVT		Hordolum interum	NONE			1						1	Computerised tomogram; Coordination abnormal; Hordeolum; Vaccination complication	FLU3~SANOFI PASTEUR~U2292AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1209F~1~IM~LL~HEP A (VAQTA)~1|PNC~PFIZER\WYETH~B08666H~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0270773	01/18/2007	MN	57.0	57		F	01/10/2007	Severe vertigo, nausea, paleness, weakness, neck/back/shoulder pain.  Follow-up information received - Pt described as : within 24 hours									Y	12/07/2006				PUB	PUB		NONE	NONE			1						1	Asthenia; Back pain; Musculoskeletal pain; Nausea; Neck pain; Pallor; Vertigo	FLU3~SANOFI PASTEUR~U2164AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270775	01/18/2007	AL	11.0	11		M	12/26/2006	12/23 to 12/25/06 had golf ball size swelling at injection site, redness, let deltoid x 72 hours, low grade fever x 24 hrs. Mom reported to nurse on 12/26/06.									Y	12/22/2006	12/23/2006	1		PVT	PVT	Zyrtec	Runny Nose, cough (allergies)	NKDA, allergic rhinitis.			1						1	Injection site erythema; Injection site oedema; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500442~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TD~SANOFI PASTEUR~C2631A~1~~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0270776	01/18/2007	VA	20.0	20		M	01/06/2007	About 10:15am Pt received Hep B/Flu vaccine. 1030 pt returned with bright red macular rash arms, chest, neck, trunk denies SOB, denies chest tightness or dizziness, c/o 8/10 bilateral headache and feels very weak. Pt transported to medical center ER. Arrived at 1130am. Seen by MD at 1700, rash subsided at about 1130 am but HA still 5/10 and weakness. Spoke with units POX on Sunday Jan 8 2007. Pt back at unit states no after effects Pt can take 3rd Hep B when due per ER MD.				Y					Y	01/06/2007	01/06/2007	0	NONE	OTH	MIL	NONE	NONE	NONE			1						1	Asthenia; Erythema; Headache; Rash macular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA244AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB360CA~2~IM~RA~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0270777	01/18/2007	IN	27.0	27		F	01/09/2007	Local swelling VS infection at site entire arm, required ER treatment two night IV antibiotics and 2 courses of oral. Took 1 week 12/08/06 to recover.				Y					Y	12/01/2006	12/01/2006	0	Had increased WBC count	PVT	PVT	Trinessa (Birth Control)	Sore throat, cough, asthma	Allergy to amoxicillin			1						1	Injection site infection; Injection site oedema; White blood cell count increased	FLU3~SANOFI PASTEUR~62184AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0620F~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0270778	01/18/2007	NC	1.26	1	.3	M	01/11/2007	Redness, vesicles at Varivax injection site (LA SQ)-started 12/15/06. Lasted approx 2 weeks now scared area.									Y	12/04/2006	12/15/2006	11		PVT	PVT	NONE	NONE				1						1	Erythema; Injection site vesicles	DTAP~SANOFI PASTEUR~~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2242AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0804F~1~IM~RL~HEP A (VAQTA)~1|HIBV~MERCK & CO. INC.~~4~IM~LL~HIB (PEDVAXHIB)~1|VARCEL~MERCK & CO. INC.~1056F~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0270782	01/18/2007	MI	1.23	1	.2	M	12/02/2006	reddened area 2 1/2 by 1 inch									Y	11/02/2006	11/29/2006	27	NONE	PUB	OTH		NONE				1						1	Erythema	DTAP~SANOFI PASTEUR~41965AB~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~42200LA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08672H~4~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0270783	01/18/2007	OH		1	.6	F	01/11/2007	6 hr post vaccine edema supra pubic area at 24 hr nearly resolved									Y	01/08/2007	01/09/2007	1	NONE	UNK	UNK		NONE	RAD			1						1	Oedema	FLU3~SANOFI PASTEUR~62259AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0938F~UNK~IM~RL~HEP A (VAQTA)~1	USA		Influenza
0270785	01/18/2007	NJ	58.0	58		F	11/03/2006	Right arm swelled, warm to touch 11/3, red patches around injection site. Benadryl 50 mg and Tylenol 1000 mg. No fever. Arm sore to touch.  Local reaction right deltoid				Y					U	11/01/2006	11/01/2006	0		PUB	PUB	NONE	NONE	asthmatic-allergic to horse serum		JN200701	1						1	Injection site erythema; Injection site pain; Injection site reaction; Injection site warmth; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70739~7+~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1048P~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0270819	01/18/2007	MA	38.0	38		F	01/18/2007	Within 5 hours of injection, patient states the injection site was red and swollen to the size of an apple.  Within 24 hours of injection, patient states her arm was red and swollen to the size of a grapefruit.  Over the next several days, patient states her arm was progressively worse to the point that her arm was purple, and her fingers were swollen and her chest and neck were sore.  On 12/1/06, 17 days after the injection, patient visited the Emergency Department to r/o Hematoma.  She states an ultrasound was negative, and she was prescribed Cephalexin 500 mg x3/day for 10 days, ice and a sling.  Patient states within 24 hours of treatment, she experienced relief from pain and a reduction in the arm swelling.				Y					Y	11/14/2006	11/14/2006	0	Ultrasound on 12/1/06-normal	PUB	PVT	Tenormin 50 mg qd, Zoloft (weaning)	None	None			1						1	Chest pain; Injection site erythema; Injection site oedema; Neck pain; Oedema peripheral; Skin discolouration; Ultrasound scan normal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA237AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0270822	01/18/2007	NC	59.0	59		M	01/18/2007	Tendonitis in shoulder muscles from 2 days after the shot for a period of about 3 months.  Pain is at the location of the shot.  This same thing happened last year in the other arm.  Twelve years prior to these two events, there were no problems (soreness only) with the flu shot after one week. 8/2/07-office note received. Patient not seen on 10/14/06 but seen on 4/20/07-C/O pain in right shoulder from flu shot. Right subacromial pain when actively moved. Gradual onset of shoulder joint pain, worse on rising. Feels better after normal movement. Causing inability to sleep and lying on affected side. Increased by raising arm in any direction. PE: tenderness and warmth over lateral apect of right shoulder. No tenderness over tendons. Normal movement of extremities. DX: Myalgia and myositis in right shoulder after flu shot. It happened a year ago in the left shoulder with flu shot. Follow-up: Given Flu Shot on 10-12-2006 at drug store, a day or two after the shot was administered my right shoulder became sore where the shot was given. After a few weeks the frequency and amount of pain increased. Periodic and daily pain, similar to a muscle strain or nerve reaction, have persisted for 8 months. After 6 months I went to my doctor and he said it was a reaction to the preservative in the flu shot, and not to take any more flu shots. A similar event happened with the 2005 flu shot that I took, but the symptoms and pain ceased after about 4 months.				Y				Y	N	10/12/2006	10/14/2006	2		OTH	PVT	None	None	None	Sore shoulder for 4 months.~Influenza (Seasonal) (no brand name)~1~58.00~Patient		1						1	Injection site pain; Insomnia; Pain; Skin warm; Tenderness; Tendonitis	FLU3~SANOFI PASTEUR~U2186AA~7+~IJ~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0270827	01/18/2007	WA	37.0			M	01/18/2007	According to Admitting physician,  Pt c/o multiple neurolgic findings and MRI changes consistent with a CNS demyelination syndrome. He reported receiving the influenza vaccine in the weeks prior to symptom onset. Pt received IV steriods.  Brand of IM influenza vaccine unknown.			Y		Y				Y				MRI results	UNK	UNK						1						1	Demyelination; Neurological examination abnormal; Nuclear magnetic resonance imaging; Nuclear magnetic resonance imaging abnormal	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0270829	01/18/2007	AL	39.0	39		F	01/18/2007	HEADACHE-2 HOURS,   FEVER,CHILLS,DYSPNEA,TIGHT FEELING IN THROAT-6 HOURS     EDEMA & ERYTHEMA OF FACE-12 HOURS   EDEMA OF FACE AND HANDS-ONE WEEK    HYPOTENSION-12 HOURS             TREATMENT--IV FLUID, STEROIDS, BENADRYL, CARDIAC MONITORING 01/22/07-records received and reviewed for DOS 01/03-01/05/07 DC DX: Allergic reaction to influenza vaccine:Tachycardia Present illness:two hours after flu shot developed headache and subsequent fever, chills, fast heart rate and funny feeling in her neck. No difficulty breathing. Only prior symptoms in past were a midsternal intermittent tightness for past 3 weeks.  TX: Solumedrol and Benadryl in ER					Y	2			Y	01/03/2007	01/03/2007	0	FLU TEST NEGATIVE, WHITE BLOOD COUNT 5.2 WITH 88% GRANULOCYTES, SINUS TACHYCARDIA ON EKG WBC 5.2, 88.8% granulocytes.  EKG: sinus tachycardia, borderline atrial heart enlargement . HR 114. Echocardiogram:trivial mitral and tricuspid regurgitation. Labs: Flu test negative. UA specific gravity 1.020, pH 7.5,  Creatinine kinase 239, Troponin-I 0.06	UNK	UNK	NONE	NONE	NONE			1						1	Chills; Dyspnoea; Erythema; Face oedema; Headache; Hypotension; Influenza serology negative; Oedema peripheral; Pyrexia; Sinus tachycardia; Tachycardia; Throat tightness; White blood cell count	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA240BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0270832	01/18/2007	AZ	2.0	2	1	F	01/18/2007	emesis x1 after influenza immunization.  No other signs of anaphylaxis and did well w/o intervention.  Allergist tested and found that she was allergic to influenza skin prick test and considered this event as mild anaphylaxis.									Y	12/14/2006	12/14/2006	0	+ skin test to influenza vaccine	MIL	MIL	none	no	nonw			1						1	Anaphylactic reaction; Hypersensitivity; Laboratory test abnormal; Vomiting	FLU3~SANOFI PASTEUR~u2308aa~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~ahavb077ba~2~IM~LA~HEP A (VAQTA)~1	USA		Influenza
0270834	01/18/2007	CT	1.05	1	.0	M	12/13/2006	Fever, redness and swelling Left thigh seen by medical doctor. Give Tylenol/Motrin for fever and discomfort.									U	12/04/2006	12/08/2006	4		PVT	PVT		NONE				1						1	Erythema; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U2174EA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0741F~2~IM~LL~HEP A (VAQTA)~1|HIBV~MERCK & CO. INC.~0086F~1~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08666C~4~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0270847	01/19/2007	WA	47.0	46		F	01/14/2007	10-31-06 flu vaccine given. Complained of left upper arm pain, spasm, immedial bruising, muscle spasm, hurts to raise and bend Left arm since 12-6-02. Seen by doctor 12-6-06 and 12-27-06.				Y					U	10/31/2006	10/31/2006	0	NONE	PVT	OTH	Zynthrois, Asrcol, Imuran	NONE	Codeine, ulcerative colitis			1						1	Contusion; Injection site pain; Muscle spasms	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA22AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0270849	01/19/2007	MA	4.0	4		F	01/17/2007	Mom called to report that her daughter developed a temp of 102.9 on the 10th day after her routine 4 year old immunizations on 1/4. She received MMR with Varicella (Proquad), DTaP and IPV. The follow day, temp down to 100.										01/04/2007	01/14/2007	10		PVT	PUB	NONE	NONE		Seizures~Measles + Mumps + Rubella (MMR II)~0~0.00~In Patient		1						1	Pyrexia	DTAP~SANOFI PASTEUR~U1813CA~5~IM~~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2198AA~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y0824~4~IM~~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~1091F~2~SC~~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0270851	01/19/2007	WI	1.03	1	.0	M	01/12/2007	Fever 12/30/06 max 102F after vaccines today. Seizure like activity with fever. Taken to Emergency Room. 2/2/07 Received medical records from hospital ER which reveal patient experienced fever & seizure activity for approx 1 min following vax x 4 on 12/30.  Had been well for week prior to vax & no sick contacts.  Temp in ER was 102.3. Tx w/antipyretcis in ER.  D/C to home w/o further seizure activity. FINAL DX: Viral syndrome &  possible febrile seizure.				Y					Y	12/30/2006	12/30/2006	0	NONE. Emergency documented in ER 102.3F rectal.	PVT	PVT	NONE	NONE	NONE			1						1	Convulsion; Pyrexia	FLU3~SANOFI PASTEUR~U2220AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1014F~3~IM~RL~HIB (PEDVAXHIB)~1|MMRV~MERCK & CO. INC.~1119F~1~SC~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08674A~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0270860	01/19/2007	VA	74.0	74		F	01/19/2007	On 10/30/6 pt rcv'd flu vaccine in L arm and Tdap vaccine in Rarm.  R arm near injection site sore the next day and still sore today near injection site and with certain arm movements--ie. adducting arm.									N	10/30/2006	10/31/2006	1	none	UNK	UNK	Evista, Actonel	None; seasonal allergies	osteoporosis			1						1	Injection site pain	FLU3~EVANS VACCINES~71826~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~2492BA~2~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0270863	01/19/2007	NM	0.82	0	.8	M	01/19/2007	Febrile Seizure approximately 10.5 hours after vaccination.  1/22/07 Received medical records from reporter which reveal patient seen 1/18 for flu shot & was well at that time.  Seen again on 1/19 s/p ER visit for febrile seizure.  Exam at that time found bulging red bilateral TMs.  Treated w/antibiotics. 1/26/07 Received medical records from hospital which reveal patient experienced an apneic spell with cyanosis, congestion & seizure activity at home.  On exam, right ear TM reddened. Given 1 dose of antibiotic.  No further seizure activity in ER & was d/c to f/u w/PCP next day.   FINAL DX: Febrile seizure.				Y					Y	01/18/2007	01/18/2007	0	CBC wnl;  Electrolytes wnl; CXR wnl;  EEG and EKG pending. LABS: Initial CBC WNL with 9.6,  monos 14.5  Later CBC showed WBC 7.6, neutros 48.7, lymphs 30.9, monos 17.2.  CXR WNL.  Blood c/s neg in 72 hrs.	UNK	UNK	Robitussin CF	mild erythema of pharynx.  No complaints.	Cleft lip s/p repair.			1						1	Blood electrolytes normal; Chest X-ray normal; Electrocardiogram; Electroencephalogram; Febrile convulsion; Full blood count normal	FLU3~SANOFI PASTEUR~UT2175BA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0270864	01/19/2007	NC	36.0	36		F	01/19/2007	Patient returned to clinic on the day following flu shot with complaint of facial swelling (area around eyes & cheeks) which she noticed upon awakening on the day after the shot. No itching, rash or other swelling. No hx. of egg allergy. Takes no meds. Only known drug allergy is penicillin.  Exam revealed no significant swelling of face or elsewhere, no rash and no respiratory distress. B/P: 130/84, P 64. Lungs clear. No swelling of pharyngeal mucosa. Prescribed Benadryl 25-50 mg. q6h prn (#12)and patient advised to go to ED or return here prn return of swelling or other symptoms.									Y	12/19/2006	12/20/2006	1	None	PUB	PVT	None	None	Allergy to penicillin (by history)			1						1	Swelling face	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72005~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0270865	01/19/2007	IL	11.0			F	01/19/2007	Per phone call received from pt's mother on 1/18/2007: Taken to the ER 1 or 2 days after receiving the Pneumovax vaccine with a red raised area on her right deltoid with a surrounding rash, welts and blisters.				Y					Y				none	UNK	UNK	unk	Chron's, primary immune deficiency syndrome, pancreatitis, ulcers, probable leukemia	PIDS, chron's, pancreatitis			1						1	Injection site oedema; Injection site rash; Injection site vesicles; Urticaria	FLU3~SANOFI PASTEUR~2196aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0618F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0270866	01/19/2007	CA	0.5	0	.5	M	01/19/2007	telephone call from mother approximately 24h after dtap,ipv,hib,pcv-7, and influenza izs. mo stated that 1h after izs given baby began twitching all over, not actually convulsing, but continuous twitching in all limbs baby remained alert, fussy with fever to 103 degrees. no prior reaction to previous izs. parents called paramedics, pulse ox, and vital signs all stable. as of 1/18/07 late in afternoon rare twitch, with fever to 101, less fussy.									Y	01/17/2007	01/17/2007	0	n/a	PVT	PVT	none	conjunctivitis	none	see above~ ()~NULL~0.50~In Patient|unknown~ ()~NULL~~In Sibling1		1						1	Agitation; Muscle twitching; Pyrexia	DTAP~PFIZER\WYETH~c552aa~2~IM~LL~DTAP (ACEL-IMUNE)~1|FLU3~SANOFI PASTEUR~u21740a~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~uf058aa~2~IM~RL~HIB (ACTHIB)~1|IPV~PFIZER\WYETH~y1031~1~IM~LL~POLIO VIRUS, INACT. (NO BRAND NAME)~1|PNC~PFIZER\WYETH~b58845d~2~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0270868	01/19/2007	CA	29.0	29		F	01/19/2007	I received a flu vaccine on Nov.16, 2005 in my childs pediatricians office.  I did not give the kids the shot becasue they were sick and they told me to get one since I am a teacher.  I said I didnt need one and they convinced me to get it as I was paying at the front desk for my kids appointments.  I told them I was not fully recoved from bronchitis that I had had for a month and they said ready and I said jokingly dont hurt me.  Then after that I was not feeling well.  My arm was hot, red and had a lump in it.  Then on December 3, 2005 I went through my first paralysis.  I was so sick, nauseated, dizzy, weak, muscle spasms all over my body, tonguie swelled up, excessive thirst, loss of urination, decreased weight by 20lbs in a couple weeks, loss of appetite, slurred speach, fogged mind, major headaches, couldnt see, numbing, tingling, burning,extreme pain and still in pain etc.  I went through intermittent paralysis for weeks went to the ER several times, neurologist, accupuncture, chiropractor, MD, reflexologist, osteopath, homeopath, endocronologist, chiropractic neurologist.  Anyone who I thought could help.  It has been over a year now and I am still unable to work because I get tingling, numbing, burning sensations, extreme fatigue and exhaustion, weak muscles, pain in all joints, blurred vision.  I cant make it through the day without a nap and resting because if I clean the house I am so sore and tired.  I cant even do activities with my children for long periods.  My life, dignity, independence have been stripped away.  I continue accupuncture and am going to see another specialist but am willing to try anything and everything to get my life back. I almost lost my life and I need to take care of my 2 beautiful children. My son has had problems since he went back for his shot too.  congestion that is chronic and chalazions, swollen eyes, so bad he had to got to the ER.  I have pictures that are sickening to even look at.  02/19/2007 MR received from one of the treating hospitals for 2 ER visits of 12/04/2005 and 12/06/2005 for c/o back pain, and polyuria, polydipsia, and flank pain.  Seen 12/04/05 for back pain after bending over and twisting to catch something.  Also c/o increasing tingling in arms, legs, and jaw. PE shows spasm of the neck muscles. Palpation elicits tingling sensations up to the side of her neck and into her jaw, as well as into  the arm. Paralumbar spasm noted.  Palpation elicits shooting pain into her leg.  Walks stiffly.  Otherwise WNL. D/C DX: Acute right cervical spasm, Right lumbar spasm. Xerostomia.  Seen again 12/06/2005 for c/o polyuria, polydipsia, and flank pain. Migratory numbness and weakness also noted. D/C DX: Polyuria, polydipsia of unclear etiology.  Migratory numbness and weakness of unclear etiology. Ruptured right ovarian cyst.  03/05/2007 MR received from 2nd treating hospital for ER visit on 12/09/2006 for c/o multiple episodes of tingling and paresthesias coming up from her legs and her hands, to affect her whole body. Episodes last 15-20 minutes and are associated with feeling cold, weakness, and difficulty speaking.  PE: WNL except for minimal epigastric tenderness to deep palpation. Neuro exam WNL except for 3+ knee jerk reflexes bilaterally.   No additional labs or diagnostics done in addition to above. DX: Paresthesias of unclear etiology.  Transient weakness of unclear etiology.  03/22/2007 MR received from MD for initial visit on 2/9/2006 with c/o of having an allergic reaction from flu shot. PE: Grasp 3+/3+, Bicep st. 3+/3+, tricep st. 2+/2+, Bicep reflexes 1+/1+, K (knee?) 3+/3+. Quad st. 4+/4+.  Poor to doughy muscle tone in calves.  Muscles sore diffusely.  Romberg sl. positive.  Otherwise, WNL. Impression:  Post-vaccine peripheral neuropathy.  F/U 2/14/06 neuro exam- Bicep st. 3+/3+, Tricep st. 1+/1+, Extended arm: 12 sec.  Balance one leg:  12 sec.  Sterognosis 12/12. Impression:  Post vaccine peripheral neuropathy.  Myalgia. Myositis. F/U 3/15/06 Energy level better, burning less now, able to lift the children. PE: Grasp 2+/2+, Bicep st. 2+/2+, Tricep st. 1-2+/2+, Extended arm 20 sec., Balance one leg 7-10 sec., Quad st. 3+/3+. Impression:  Peripheral neuropathy.  Myositis.  F/U 4/13/06 Doing much better, has some good days now. Strength improving. PE: Affect improved.  Extended arm 30 sec., Grasp 3+/3+, Bicep st. 3+/3+.  Tricep st. 3+/3+, Quad st. 3+/3+.  Bicep reflex 1+/1+, K (knee?) 1+/1+. Impression:  Peripheral neuropathy.  Myositis.   Several more F/U as above with same DX. with the addition of a DX of Fatigue on 10/26/2006. Brief Neuro. consult of 2/21/2006 included, with Impression: Resolving paresthesias and myalgias of the trunk and limbs, staus post flu vaccine injection. Spoke with MD re: a correspondence included in MR which states that the diagnosis was consistant with a Guillian Barre syndrome with muscle weakness and aches. With no other mention of GBS in any of the medical records, verification of that DX was needed.  MD stated GBS is not a final DX, but symptoms could have been GBS-like. 1/120/2010 Fatigue, muscle pain, eye disturbances, nerve hypersensitivity in arms, hands and feet always cold. 04/01/2010 Still have pain and fatigue, blurred vision, weird sensation. New diagnosis of Chronic Fatigue, Fibromyalgia. Dr. states it was from vaccine toxins that set off Fibromyalgia.			Y	Y					N	11/16/2005	12/03/2005	17	post vaccine peripherial neuropathy. Labs and Diagnostics 12/4/05 :  Blood sugar WNL. Labs and Diagnostics 12/6/05: MRI brain unremarkable except for small arachnoid cyst vs prominent sulcus.  CT pelvis shows 2cm right ovarian cyst, no significant abnormalities. CT lumbar spine shows partial lumbarization of S1. CT brain unremarkable. Labs unremarkable. Labs unremarkable except elevated AM Cortisol level of 25.2	UNK	UNK	none	recovering from bronchitis	none. PMH: none.  Allergies: Bactrim and Versed.			1						1	Activities of daily living impaired; Anorexia; Arachnoid cyst; Arthralgia; Blindness; Blood cortisol increased; Blood glucose normal; Computerised tomogram abnormal; Dizziness; Dysarthria; Erythema; Eye disorder; Fatigue; Fatigue; Feeling abnormal; Feeling abnormal; Fibromyalgia; Gait disturbance; Headache; Hypoaesthesia; Impaired work ability; Lumbarisation; Malaise; Mass; Muscle spasms; Muscular weakness; Nausea; Neurological examination normal; Neuropathy peripheral; Nuclear magnetic resonance imaging brain abnormal; Ovarian cyst ruptured; Pain; Pain; Paraesthesia; Paraesthesia; Paralysis; Peripheral coldness; Positive Rombergism; Scan brain; Skin warm; Speech disorder; Swollen tongue; Thirst; Urine output decreased; Vision blurred; Weight decreased	FLU3~SANOFI PASTEUR~U1868AA~2~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0270880	01/19/2007	OH	1.07	1	.1	F	01/04/2007	Patient had a febrile seizure three days after receiving immunizations.				Y					Y	12/20/2006	12/23/2006	3		PVT	PUB		NONE	NONE			1						1	Febrile convulsion	FLU3~SANOFI PASTEUR~U2245AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~0978F~UNK~IM~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08670F~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0270881	01/19/2007	IL	0.82	0	.8	M	01/19/2007	On 1/12/07 Patient had 9 month checkup and received 3rd Hep B shot and 1st 0.25ml (thierosal-free) fluzone (prefilled syringe) injection. Within 15 minutes patient developed hives on cheek, torso and legs. Resolved after receiving Benadryl 3/4 tsp by mouth.  Follow-up: Developed hives on cheek, shoulder, torso within 20 after adm. of FLUZONE and hep B #3. No swelling or respiratory distress. Resolved with BENADRYL. Referred to allergist for follow up. Since then tolerated FLUZONE #2 and MMR-V without incident.									Y	01/12/2007	01/12/2007	0	referred to allergist All skin tests/IgE tests negative for egg, yeast, porcine gelatin -> possible dermato graphism per allergist.	PVT	PVT	NONE	NONE	NONE atopic dermatitis			1						1	Blood immunoglobulin E normal; Skin test negative; Urticaria	FLU3~SANOFI PASTEUR~UT2174LA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0541F~2~IM~RL~HEP B (RECOMBIVAX HB)~1	USA		Influenza
0270874	01/21/2007	SC	21.0	21		F	01/21/2007	Woke up after feeling very hot, entire body broke out into a sweat then got freezing cold (all within a 10 minute period), felt incredibly nauseous, blurry and darkened vision, hands were extremely shaky, then collapsed back asleep because I felt zapped of energy. Woke up three hours later and felt completely normal.									Y	01/19/2007	01/20/2007	1	None.	PVT	UNK	None	None	None			1						1	Feeling cold; Feeling hot; Hyperhidrosis; Listless; Nausea; Tremor; Vision blurred; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~?~1~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0270490	01/22/2007	WA	71.0	71		F	01/12/2007	No energy 1 week after, failing to thrive after that, slept alot, mild throat couth, HA, earaches, then developed into severe low back pain prompted MD Visit. Sent to ERD with bilateral pneumonia.					Y	4			Y	10/25/2006	11/01/2006	7	CXR showed bilateral pneumonia	OTH	OTH	Lipitor					1						2	Angiogram pulmonary abnormal; Atrial tachycardia; Blood culture negative; Blood sodium decreased; Chest X-ray abnormal; Chronic obstructive pulmonary disease; Electrocardiogram abnormal; Fatigue; Hyponatraemia; Lethargy; No reaction on previous exposure to drug; Pneumonia; Supraventricular tachycardia; Tobacco user; White blood cell count increased; Asthenia; Back pain; Chest X-ray abnormal; Cough; Ear pain; Failure to thrive; Headache; Hypersomnia; Pneumonia	FLU3~SANOFI PASTEUR~U2218DA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUX~UNKNOWN MANUFACTURER~G0008~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0270883	01/22/2007	CA	4.0	4		F	01/08/2007	Patient had immunizations Wed 1/3/07, by Friday after school mom noticed band aid, itching on left deltoid. Got ecchymosis below the puncture site. Bright red and swollen. Mother gave child Benadryl Saturday and Sunday. Itching a lot at left forearm. Today slight redness and warmth below puncture site.									Y	01/03/2007	01/05/2007	2		PUB	PUB	NONE	NONE	NONE			1						1	Ecchymosis; Erythema; Injection site erythema; Injection site warmth; Pruritus; Swelling	DTAP~SANOFI PASTEUR~U1615AA~5~~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2272AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0804F~2~~RA~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~Y1031-Z~4~~LA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0270892	01/22/2007	VA	34.0	34		F	12/28/2006	After patient completed clinical exam at approximately 3:50pm. Patient given flu vaccine. After taking a few steps down hallway to leave at approximately 4pm patient complained of burning, itching and feeling broken out on face. Patient noted to have red, flushed cheeks. Right cheek appeared to have a circular area about dime size with red outer area and white inner area, over Right outer eyebrow noted to be red with a few small bumps. Doctor saw patient and advised to give patient Benadryl. Approximately 4:03pm patient given Benadryl elixir 50 mg (4tsp). 4:25pm cheeks appear more normal with just a few pinkened areas, circular area on Right cheek barely visible. Area over Right eyebrow normal in appearance with only a small bump noted. Patient reported face didn't feel like it was burning or itching anymore. Patient left with mom.									Y	12/19/2006	12/19/2006	0	NONE	PUB	PUB	Depo-provera 150 mg IM Left deltoid at approx 3:52pm	NONE	No known allergies and no known medical conditions.			1						1	Erythema; Flushing; Pruritus; Rash; Skin burning sensation; Skin discolouration	FLU3~SANOFI PASTEUR~U2307AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270893	01/22/2007	TX	29.0	29		F	12/20/2006	Redness, induration of injection site 45 mm-tightness of throat, fever 101F, chills, localized pain, nausea, vomiting, diarrhea.				Y					Y	12/13/2006	12/14/2006	1	Urinalysis	PUB	PUB	NONE	NONE	UNK			1						1	Diarrhoea; Erythema; Injection site induration; Nausea; Pain; Pyrexia; Throat tightness; Vomiting	FLU3~SANOFI PASTEUR~U2282AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0270895	01/22/2007	VA	12.0	12		M	01/11/2007	Received present complaint from Emergency Room Doctor requesting name of vaccines child received 2 hours in ER. Seizure this AM in school for 2 minutes. 01/24/07- received ER report supports seizure with recommendation to see a neurologist. Seizure at school. Seen in ER lethargic . PE: WNL.				Y					Y	01/09/2007	01/10/2007	1	Referred to neurologist. records received 1/24/07-Urine tox screen negative.	PUB	PUB	NONE	some cough	NONE noted on screening questionnaire records received 1/24/07- History of asthma. Previous seizure history.			1						1	Convulsion	FLU3~SANOFI PASTEUR~U2187AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB139BA~1~IM~LA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2108AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B006BA~6~IM~RA~TDAP (BOOSTRIX)~1	USA	Emergency room visit	Influenza
0270896	01/22/2007	SC	12.0	12		M	01/15/2007	Fever, rash, redness, started on Friday 01/12/07.				Y					Y	01/11/2007	01/12/2007	1		PVT	UNK						1						1	Erythema; Pyrexia; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500441P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TDAP~SANOFI PASTEUR~C2384AA~6~IM~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0270897	01/22/2007	MA	62.0	62		F	01/16/2007	Slight swelling at site of injection within a few days after shot, never went down. No pain. As months went by, arm still seemed slightly swollen and pain began at site extending to shoulder and restricting motion.  Doctor said a hematoma had developed and sent me to PT				Y					N	10/17/2006	10/19/2006	2		PUB	UNK	albuterol, inhaler, singulair, HCTZ, prilosec	NONE	asthma, noted sensitivity to latex on consent form			1						1	Haematoma; Hypokinesia; Injection site pain; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~A204NA~1~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0270898	01/22/2007	NC	1.25	1	.3	F	01/12/2007	Approximately 9 hours after receiving MMR (fist) and influenza vaccines patient experienced a generalized tonic seizure lasting less than 2 minutes. No treatment was necessary. No past medical or family history of seizures noted.  1/23/07 T/C to reporter to request missing info.  Parents called EMS for patient & called PCP but no treatement done & did not transport to ER.  Seen by PCP following day.  1/25/07 Received medical records from PCP which reveal patient had decreased growth velocity in all parameters, slightly worse in weight w/o evidence of chronic disease.  Patient eats well but is fussy & has had several URIs & otitis media infections.  On day of initial flu vax 11/9/06, patient noted to have bilat OM & was treated w/antibiotics & referred to ENT.  Seen again on 12/19 with thrush from antibiotics & mild cough.  Next visit was on 1/11 & received flu vax & MMR after well check up.  Seen s/p seizure on 1/12 & found to be well with no further seizure activity.  No family hx of seizures.  No treatment done & no further w/u recommended unless seizure recurs.				Y					Y	01/11/2007	01/11/2007	0	NONE	PVT	UNK		NONE	NONE			1						1	Tonic convulsion	FLU3~SANOFI PASTEUR~U2248AA~UNK~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0537F~1~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0270899	01/22/2007	AZ	23.0	23		M	01/04/2007	2 weeks after receiving smallpox vaccine developed erythema at site and vesicular rash on back and chest, fever. Received Bactrim at ER for presumed cellulitis at vaccine site. Diagnosed cellulitis, generalized vaccina				Y					Y	12/15/2006	12/25/2006	10	NONE	MIL	MIL	NONE	NONE	Reaction to cedar in past.			1						1	Injection site cellulitis; Injection site erythema; Pyrexia; Rash vesicular; Vaccinia	ANTH~EMERGENT BIOSOLUTIONS~FAV103~UNK~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~PARKDALE PHARMACEUTICALS~U230FAA~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1|SMALL~PFIZER\WYETH~Y020072~UNK~SC~LA~SMALLPOX (DRYVAX)~1|TYP~BERNA BIOTECH, LTD.~Z0425-2~UNK~IM~LA~TYPHOID LIVE ORAL TY21A (VIVOTIF)~1	USA	Emergency room visit	Influenza
0270900	01/22/2007	GA	13.0	12		F	01/18/2007	Approximately 10 minutes after administering the Fluzone vaccine child began complaining that her arms and back was itching. I noticed red whelps on her back and chest. Physician was notified immediately and the patient was given Allervert (antihistamine) for allergic reaction. Fluzone was received 30 minutes after other vaccines.									Y	01/18/2007	01/18/2007	0		PVT	PUB	Albuterol, Metered dose inhaler	NONE	Penicillin allergy			1						1	Erythema; Hypersensitivity; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2177AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1995AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B001AA~UNK~IM~RA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1151F~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0270901	01/22/2007	AZ	8.0	7		F	01/08/2007	Localized swelling next day. Induration 45x25mm. 90x50 erythema. Follow up redness only.				Y					Y	01/05/2007	01/06/2007	1		OTH	PUB	Benadryl over the counter, Dimetapp for cold					1						1	Erythema; Induration; Swelling	FLU3~SANOFI PASTEUR~U2249AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1154F~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0270902	01/22/2007	MA	65.0	65		F	01/03/2007	States that the arm vaccine was administered in has been sore for 1 month (since vaccine was given).									Y	12/04/2006	12/04/2006	0	CK drawn	PUB	UNK						1						1	Blood creatine phosphokinase; Injection site pain; Blood creatine phosphokinase; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U42279AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0270903	01/22/2007	NM	58.0	57		F	01/16/2007	Fever, severe aches in joints, welts on arm. Patient had doctor visit. Treatment was time. MD stated this was a typical reaction.				Y						01/10/2007	01/10/2007	0	UNK	OTH	OTH			UNK			1						1	Arthralgia; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U2218AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0485F~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0270904	01/22/2007	MN	46.0	46		F	01/16/2007	Patient reported eruption of one hive like lesion (wheal) morning after vaccination, followed by other pimple like area over her body. No pruritis except for the first lesion. Disappeared over several hours. No shortness of breath, swelling or other symptoms. Patient reported to Public Health on 1/16/07.									Y	01/11/2007	01/12/2007	1		PUB	PVT	Unknown - none reported	NONE	Allergic to Amoxicillin-rash			1						1	Acne; Pruritus; Skin lesion	FLU3~SANOFI PASTEUR~U2282AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270905	01/22/2007	FL	61.0	61		M		Shingles received AM 3 width									Y	10/23/2006			NONE	PVT	UNK		NONE	NONE			1						1	Herpes zoster	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLVA220BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|VARZOS~MERCK & CO. INC.~0622F~UNK~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0270906	01/22/2007	NM	35.0	35		F	01/16/2007	Severe swelling, arm was erythematous and hot. Patient went to local Emergency Room. Was given Ibuprofen and codeine.				Y						01/12/2007	01/13/2007	1	UNK	OTH	OTH	UNK	NONE	UNK			1						1	Injection site warmth; Rash erythematous; Swelling	FLU3~SANOFI PASTEUR~U2218AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0485F~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0270908	01/22/2007	VA	4.0	3		M	01/15/2007	Patient was asleep by 7:30pm on 1/10/07. Around 8:15 he started crying and screaming in his bed and was restless. Mom went in to get him and picked him up. His body would tense up and go stiff and flat as a board for about 5-10 seconds and then release. About 30 seconds to a minute later he would repeat this stiffening again. During the first episode this lasted for about 15 minutes. The whole time he was going through this mom was holding him in her arms while they say on the couch. He would repeatedly call out  I want mommy as if he didn't even recognize that mom was right there and he was in moms arms. He was not cognizant of what was going on around him at all. As soon as it was over he went right to sleep as if nothing happened. This same thing went on at 9:30 and 11pm. It may have happened a fourth time, mom can't remember but the last time was at 11:15pm. Each time that it went on the reaction time was shorter. By the final time it lasted only about 3-5minutes. Every time he would wake up from his sleep crying and thrashing around very disoriented. He continued to go through the contraction and stiffening episodes and calling out I want mommy yet not recognizing that he was in mom's arms. He would not respond to anything that you said to him or asked him. If I asked him where he hurt or to point to where he hurt, he did not respond at all.									Y	01/10/2007	01/10/2007	0		PVT	PVT		Pink eye	NONE			1						1	Abnormal behaviour; Crying; Disorientation; Musculoskeletal stiffness; Restlessness; Screaming; Tension; Unresponsive to stimuli	FLU3~SANOFI PASTEUR~U2255AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270909	01/22/2007	NC	12.0	12		M	01/18/2007	Vomiting several times, headache, sore throat occurred 3 days after immunizations.				Y					N	12/22/2006	12/25/2006	3	Rapid strep throat negative. Strep throat culture negative.	PUB	PUB	NONE	NONE	NONE			1						1	Headache; Pharyngolaryngeal pain; Streptococcal serology negative; Vomiting	FLU3~SANOFI PASTEUR~U2244AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1860AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0270910	01/22/2007	OH	78.0	78		F	11/02/2006	Immediate swelling after administration of Fluzone in left deltoid. Pt offered ice pack but Pt refused. Pt said they take a blood thinner. So did not want Ibuprofen. Pt observes for approx 10 min, swelling was less but still present. Pt decided to go to family Dr. Pt said Dr told them they were ok, no further treatment necessary by Dr.				Y					Y	11/02/2006	11/02/2006	0		OTH	OTH		NONE	NONE			1						1	Injection site oedema	FLU3~SANOFI PASTEUR~U2216AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0270911	01/22/2007	NC	9.0	9		F		Large reddened area on right thigh about 4x4 inches on 1/9/07 submitted photograph taken by mother of patient. Pt not seen by MD not brought to office.									Y	12/05/2006				PVT	PVT						1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U2242AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0654F~1~IM~LL~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~1056P~2~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0270912	01/22/2007	NC	0.9	0	.9	F	01/12/2007	Rash on legs, fever, twitching to left. No fever with tick spells. Jerks 3-4 x hour happened with focusing on something. Referred to neurologist. Observation was only treatment done. Patient is better with ticks present.  1/26/07 Received neuro consult report which reveals patient seen on 12/7 for EEG & 12/8 for complete neuro eval.  Neuro exam was WNL. A video tape of the patients jerking movements was reviewed.  She rapidly twisted her head to the left & then returned back to neutral position.  No LOC, no facial expression change or any other associated movements.  No loss of eye contatct or focus & is developmentally on target. FINAL DX: Motor tic disorder; noted to be highly unusual for child of this age & probably better described as movement disorder.									Y	11/11/2006	11/21/2006	10	NONE EEG interpreted as WNL both awake & asleep.	PVT	PUB	NONE	NONE	Allergic to formula Family & birth HX: negative for tics. Positive for mental retardation in paternal second cousin who was preemie & also blind & deaf.  Patient was 7 lb 4 oz 38week delivery w/o complication.  Breast fed & allergic to formula.  Only treatment recommended was continued observation as episodes were becoming less frequent.  May have been a postviral movement disorder similar to PANDAS w/o evidence of strep infection.			1						1	Dyskinesia; Muscle twitching; Pyrexia; Rash; Tic	FLU3~SANOFI PASTEUR~UT2176CA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0270942	01/22/2007	NJ	56.0	56		F	11/03/2006	Patient noted tenderness and edematous at site of injection without redness. Patient also noticed under left axilla without lump noted. Patient had breast exam 10/15/06 without tenderness noted at that time. Patient due for mammo 11/15/06.									Y	11/01/2006	11/02/2006	1		PUB	PUB	Mavik 4 mg PO qd Hydrochlorothiazide 1/2 tsp	NONE	NONE			1						1	Injection site oedema; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70739~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0270943	01/22/2007	TX	41.0	41		F	01/20/2007	No adverse symptoms noted thus far (immediately).									U	01/20/2007				MIL	MIL		NONE	Allergies to ampicillin - hay fever			1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0270949	01/22/2007	MD	24.0	24		F	01/22/2007	PAIN AND SWELLING AT INJECTION SITE. AWAKENED FROM SLEEP FROM BITING TONGUE. LATER DEVELOPED CELLULITIS AT THE INJECTION SITE (RIGHT ARM)										10/30/2006	10/30/2006	0		MIL	MIL	SYNTHROID, ORTHO-CEPT	NONE	HYPOTHYROIDISM			1						1	Injection site cellulitis; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2286AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|JEV~SANOFI PASTEUR~EJN229A~2~SC~RA~JAPANESE ENCEPHALITIS (JE-VAX)~1	USA		Influenza
0270955	01/22/2007	CA	41.0	41		U	01/22/2007	Noted elevated area in his axillary ares. He's afebrile. It was warm to touch.  The injection site felt lumpy. Was sent to Kaiser for evaluation and was advised to monitor the sites for any S&S of infection.									Y	12/15/2006	12/18/2006	3		UNK	UNK	Antihypertensive meds	No S  & S o f cold or infections	HTN			1						1	Axillary mass; Injection site nodule; Skin warm; Erythema; Pain	FLU3~SANOFI PASTEUR~U2272AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~02272AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0270957	01/22/2007	NC	68.0	68		M	01/22/2007	Weakness in upper arm that was used for vaccination.  Influenza Vaccine administered subcutaneously on 11-8-2006.  Symptoms began to occur around 12-25-2006.  Physical therapy, nerve conduction studies have been done by VA facility in Asheville NC.  5/18/07 Received medical records from VAMC which reveal patient experienced numbness of left arm w/tingling of fingers, unable to lift left arm & difficulty using left hand since 12/31/06.  Exam on 1/8/07 revealed significantly decreased ROM of left  arm.  numbness of left arm had resolved.  Dx w/left arm neuropathy.  Referred for EMG.  PMR consult on 1/12/07 revealed left shoulder girdle atrophy & limited ROM.  Left elbow flexion was limited.  There was generalized muscle weakness of the left arm.   DTRs absent at biceps & brachial radialis & there was decreased sensation.   Issued sling & referred for OT.  Neuro consult done 2/12/07 agreed w/dx.  Treated w/steroids & referred for MRI of left brachial plexus. FINAL DX: Left Brachial plexitis.									N	11/08/2006	12/24/2006	46	Nerve conduction study LABS: EMG/NCS done 1/12/07 revealed results highly suggestive of pan brachial plexitis of left upper extremitiy in acute phase, in active process of axonal degeneration, severe involvement of upper trunk, lateral & posterior cord of brachial plexus resulting in severe weakness of shoulder girdle muscles, probably idiopathic etiology; and suspect pre-existing left CTS, asymptomatic prior to brachial plexitis.  Lyme titre neg.  MRI of brain 1/9/07 revealed a large posterior fossa arachnoid cyst & left max sinus disease.	UNK	UNK	Atenolol	none	HTN PMH: HTN, hypercholesterolemia & essential tremor of both hands			1						1	Muscular weakness; Nerve conduction studies	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69424~1~SC~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0270959	01/22/2007	MD	1.55	1	.5	F	01/22/2007	1/17/07 - Child received DTaP/ Hib, Hep A, Influenza vaccines. 1/18/07 - Febrile seizure, Temperature 102.9 rectal				Y					Y	01/17/2007	01/18/2007	1		PVT	UNK	TYLENOL given with injections	NONE	Status post 34 week preemie			1						1	Febrile convulsion; Pyrexia	DTAP~SANOFI PASTEUR~U1985AA~1~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2260AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB099CB~1~IM~LL~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0270960	01/22/2007	FL	0.85	0	.8	F	01/22/2007	Fever 105 48 hours after flu vaccine (booster).				Y					Y	12/28/2006	12/30/2006	2		PVT	PVT		NONE	NONE			1						1	Pyrexia	FLU3~SANOFI PASTEUR~UT21758A~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0271108	01/22/2007	KY	24.0	24		F	01/16/2007	Information has been received from a physician concerning a 24 year old female with no pertinent medical history or drug reactions/allergies, who on 08-Dec-2006 was vaccinated intramuscularly with Gardasil vaccine (yeast) (0.5 ml) (lot#653736/0868F). Concomitant vaccination given on an unspecified date included influenza virus vaccine (unspecified). Other concomitant medication included hormonal contraceptives (unspecified).On 09-Dec-2006, one day after receiving the Gardasil vaccine (yeast), the patient experienced breast swelling. It was reported that there was no significant pain, however the patient could not lie on her breast. Unspecified medical attention was sought. At the time of this report, the patient was recovering. Additional information has been requested.				Y					N	12/08/2006	12/09/2006	1	NONE	OTH	OTH	hormonal contraceptives		NONE		WAES0612USA02283	1						1	Breast swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~0868F~UNK~IM~~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0271110	01/22/2007	TX	16.0			F	01/16/2007	Information has been received from a physician concerning a 16 year old female who on approximately 27-Nov-2006 was vaccinated with the first dose of Gardasil vaccine (yeast) (0.5 ml) (lot#653650/0641F). Concomitant vaccination the same day included Fluvirin vaccine. It was reported that  a few days after receiving the vaccination, on approximately 01-Dec-2006, the patient experienced dizziness when standing and walking and experienced a headache. Unspecified medical attention was sought. Subsequently, the patient recovered from the dizziness and headache on an unspecified date. Additional information has been requested.				Y					Y	11/27/2006	12/01/2006	4	NONE	OTH	OTH			UNK		WAES0612USA02345	1						1	Dizziness; Headache	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HPV4~MERCK & CO. INC.~0641F~1~~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0271118	01/22/2007	MI	14.0	14		F	01/16/2007	Information has been received from the mother of a 14 year old female who on 27 Sep 2006 was vaccinated with a dose of Gardasil. Vaccination the same day included a dose of influenza virus vaccine (unspecified). Concomitant therapy included Allegra. On 28 Sep 2006, the next day, the patient developed little, itchy bumps on her legs and pimple like bumps on her back. The patient's mother reported that it may or may not have been an allergic reaction, or it could have been dry skin. The patient takes therapy with Allegra every day, although, the mother was unsure if the patient had taken it the day of the vaccination. Unspecified medical attention was sought. Subsequently, the patient fully recovered the same day. No other vaccinations have been given. Additional information has been requested.				Y					Y	09/27/2006	09/28/2006	1	UNK	OTH	OTH	Allegra		UNK		WAES0612USA02630	1						1	Acne; Dry skin; Hypersensitivity; Rash pruritic	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~UNK~~~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0271146	01/22/2007		18.0	18		F	01/16/2007	Information has been received from a physician concerning an 18 year old white female who on 27 Nov 2006 was vaccinated with Gardasil (lot number 653650/0641F). Concomitant therapy on 27 Nov 2006 included Fluvirin. On 01 Dec 2006 the patient experienced dizziness with walking or standing. On 02 Dec 2006 the patient experienced headache on top of her head. Subsequently, the patient recovered from dizziness with walking or standing and headache on top of her head. A prescription treatment was given for the experiences (not specified). Additional information is not expected.				Y					Y	11/27/2006	12/01/2006	4	NONE	OTH	OTH			NONE		WAES0612USA03644	1						1	Dizziness postural; Headache	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72222~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HPV4~MERCK & CO. INC.~0641F~UNK~IM~~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0271158	01/22/2007		15.0			F	01/16/2007	Information has been received from a nurse practitioner concerning a 15 year old female who on 27 Dec 2006 was vaccinated with a first dose of Gardasil concomitantly with a dose of influenza virus vaccine (unspecified) using a different injection site. On 27 Dec 2006, approximately  2 hours after the vaccination, the patient experienced swelling and numbness in her lower lip. On approximately 29 Dec 2006, the patient recovered without treatment. Additional information has been requested.									Y	12/27/2006	12/27/2006	0	UNK	OTH	OTH			UNK		WAES0701USA00101	1						1	Hypoaesthesia oral; Lip swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~1~~~HPV (GARDASIL)~1	USA		Influenza
0271218	01/22/2007	AZ	1.08			M	01/16/2007	Information has been received from an office manager in a physician's office concerning a 13 month old male who on 12 Dec 2006 was vaccinated inadvertently with a dose of Rotateq vaccine live (human-bovine) when Rocephin was ordered. After the inadvertent administration the patient was given Rocephin, 250 mg as well as a dose of influenza virus vaccine (unspecified). At the time of the report the patient had diarrhea and was throwing up. No other information was provided. Additional information has been requested.									U	12/12/2006	12/12/2006	0	UNK	OTH	OTH	Rocephin		UNK		WAES0612USA02525	1						1	Diarrhoea; Vomiting; Wrong drug administered	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|RV5~MERCK & CO. INC.~~UNK~~~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0271219	01/22/2007	AZ	1.0			M	01/16/2007	Information has been received from a medical assistant concerning a 12 month old male, with no allergies, who on 12-Dec-2006 was vaccinated with a dose of ROTATEQ (human-bovine) (Lot # 654247/0600F). Concomitant vaccine included a dose of influenza virus vaccine (unspecified). On 12-Dec-2006 the patient experienced vomiting after returning home from the physician's office. The patient was brought back to the office and found to have an ear infection. The patient was prescribed ROCEPHIN. It was reported that the patient was not hospitalized. No product quality complaint was involved. Additional information has been requested.				Y					U		12/12/2006		Unknown	OTH	OTH			Unknown		WAES0612USA02530	1						1	Ear infection; Inappropriate schedule of drug administration; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|RV5~MERCK & CO. INC.~0600F~UNK~UN~UN~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0271251	01/22/2007	VA	4.0			M	01/16/2007	Information has been received from a health professional concerning a 4 year old male who on 05 Dec 2006 was inadvertently vaccinated with a dose of Zostavax (lot # 652936/0981F) instead of MMR II. Concomitant vaccination included influenza virus vaccine (unspecified), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine. The nurse was told they had the new MMR varicella vaccine, she grabbed a vial and administered it to the patient without reading it and then realized it was Zostavax. No symptoms were noted. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.				Y					U	12/05/2006	12/05/2006	0	NONE	OTH	OTH			NONE		WAES0612USA01063	1						1	Wrong drug administered	DTAP~UNKNOWN MANUFACTURER~~UNK~~~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~0981F~UNK~~~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0270993	01/24/2007	NC	1.33	1	.3	M	01/10/2007	Flu vaccine given 12/27/06 at 1:30. Mother stated felt warm and fussy that day at 5:00. On 12/28 at 2am had fever and gave Tylenol and seemed ok when woke up that am was running and fell on milk bottle in his mouth. Hit nose. Immediate started seizure and carried to ER by rescue squad. ER had difficulty controlling seizure. Child was airlifted to medical center. Talked with mother on 1/10/07 states child was ok now. Not on any medications. No more seizures. No problem with any prior immunization. Child did have seizure once before at 11 months of age. It was very brief and did not require MD visit. Mother informed MD of this. Brother has febrile seizure.  03/15/2007 MR received from treating hospital for c/o of seizure activity following flu vax.  Upon arriving home from appt., mother noted child had a fever and cough. The following morning, child began having generalized seizure activity and EMS was called.  Seizure activity reduced with Ativan, but had several episodes each responding to treatment. Child was transfered to current hospital. Seizure activity stopped and child was discharged the next day.  Assessment: RSV and febrile seizure with atypical presentation.				Y	Y	2			Y	12/27/2006	12/27/2006	0	Normal labs.  Labs and Diagnostics:  Chem-7 WNL-Glucose 155.  CBC with WBC of 13.9, Hct 33.7, Hgb 11.0.  UA trace blood, 2 RBCs, 1 WBC, RSV (+).	PUB	PUB	NONE. Meds:  none.	Runny nose only	NONE. PMH:  34 week premie twin.  Allergies: NKDA.		NC07008	1						1	Agitation; Convulsion; Fall; Feeling hot; Injury; Laboratory test normal; Pyrexia	FLU3~SANOFI PASTEUR~U2176EA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0270994	01/24/2007	FL	54.0	54		M		Within 24 hours of immunization, veteran developed strong muscle spasms in neck and shoulders.  04/09/2007 MR received for ER visit of 11/19/2006 for c/o SOB, subjective fever and sweats.  Txd with antibiotics and Tylenol. PE: unremarkable. Temp. 102.2. DX:  Pneumonia-acute.  Dyspnea-acute. Spoke with reporter.  Pt. did not seek outside treatment for AE.  Just mentioned AE symptoms to reporter on homecare visit for other issues.				Y	Y	4			Y	11/10/2006	11/11/2006	1	NONE. Labs and Diagnostics:  CXR showed a LUL infiltrate.  CBC WNL.  Chem. normal. UA showed 5-10 WBCs (pt. has foley cath.)	OTH	PUB		NONE	Flexaril, Ciprofloxacin, Methadone. PMH: Quadriplegia 2' MVA in 2003, Spasms, Hep C., HTN. Asthma. Allergies: Cipro, Flexeril, Morphine, Methadone.			1						1	Muscle spasms	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA221AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0270996	01/24/2007	NY	39.0	39		M	01/18/2007	Patient stated about 3 hours after receiving flu vaccine developed shortness of breath, wheezing and a rash on his abdomen and chest. The above is a physician and he self treated with a nembulizer treatment which improved respiratory symptoms. The rash persisted for 1-2 weeks.			Y						Y	12/21/2006	12/21/2006	0	NONE	OTH	PVT	NONE	NONE	Allergic to Zithromax and Clindamycin			1						1	Dyspnoea; Rash; Wheezing	FLU3~SANOFI PASTEUR~U2260AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0270999	01/24/2007	MS	68.0	68		F	12/05/2006	swelling, redness right arm, below injection site. Discomfort right arm				Y					Y	12/04/2006	12/05/2006	1		PUB	PUB	Albuterol, Flovent, TheoDur, Diomax	NONE				1						1	Injection site erythema; Injection site swelling; Limb discomfort	FLUX~UNKNOWN MANUFACTURER~71826~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0607B~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0271003	01/24/2007	NC	1.12	1	.1	F	01/17/2007	MGM reports noticing blister with small white (left arm-back) head on 01/14/07.  On 01/16/07 the blister opened and bled a little.  Area is red, warm to touch, firm knot.  Redness measures 30 x 25 mm. Has not been treating with any medicines or ointments.  Also reports 3 additional blisters on back of neck onset 1/13/07.									Y	12/01/2006	01/14/2007	44		PUB	PVT	NONE	NONE	NONE		NC07009	1						1	Blister; Erythema; Feeling hot; Skin haemorrhage; Upper extremity mass	FLU3~SANOFI PASTEUR~U2176EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~111BF~1~SC~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0271004	01/24/2007	CA		3		F	01/23/2007	Client received her flu shot in left deltoid at approx 9am. At 730 pm same night she experienced painin her hip joint, sweating, lethargy-in waves.  Her parents took her to the ER. No dx									Y	11/10/2006	11/10/2006	0	not know-seen in ER	PUB	PUB	NONE	NONE	NONE			1						1	Arthralgia; Hyperhidrosis; Lethargy	FLU3~SANOFI PASTEUR~U2193AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0271005	01/24/2007	NM	54.0	53		F	01/16/2007	bright red 4x4 patch, swelling on the arm									U	01/12/2007	01/13/2007	1	UNK	OTH	OTH	UNK					1						1	Erythema; Swelling	FLU3~SANOFI PASTEUR~U2218AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0485F~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0271006	01/24/2007	FL	42.0	42		M	01/16/2007	Patient came in to clinical 1/11/07 for a flu shot and a pneumonia vaccine.  Pneumonia vax given in left deltoid.  4-5 hours after vax given, left arm began to swell and turn red. Arm painful from site to elbow.  Symptoms lasted 4-5 days.									Y	01/11/2007	01/11/2007	0		PUB	PVT		NONE	Diabetes			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2307AAA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0958F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0271008	01/24/2007	VA	4.0	4		M	01/17/2007	Several hrs after vaccination pt developed erythema and around injection site which continued to progress over next 36 hours TX with Rest, elevation, cool compress.				Y					Y	11/29/2006	11/30/2006	1		PUB	UNK						1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U2175HA~6~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0271010	01/24/2007	TX	6.0	6		F	01/16/2007	Swelling, redness and itching of large area of deltoid where vaccine given about 6 hours after.									Y	01/05/2007	01/05/2007	0		PVT	PVT	Depakote		Seizure disorder, Asthma, allergies			1						1	Injection site erythema; Injection site pruritus; Injection site swelling	FLU3~SANOFI PASTEUR~U2250AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0271017	01/24/2007	MO	52.0	52		F	01/18/2007	Diagnosed Guillain Barre Syndrome, C/O fever, leg pain, numbness in feet. Pain elbows/shoulders. C/O'd dizziness, vomiting, lethargic. As of today we finally made contact again, after I have left messages. Diagnosis confirmed. Patient was hospitalized later with staff infection (new) and diabetes (new to her).  02/02/2007 MR received from PCP.  Office visit 10/06/2006 3 days s/p flu vax. given in local pharmacy.  Pt. has c/o leg pain (left worse than right) and toes going numb. PE: Muscle tone good, SLR normal, Right toes numb.  Tx.'d with Prednisone. By 10/09/06 pt. was feeling better but developed flu sx. Increased leg pain on 10/20/2006.  Pt. was hopitalized on 10/29/06 for abscesses of the tricep and groin. Treated with abx. Impression: 1) Abscesses of left triceps and left groin area with surrounding cellulitis.  2) New onset Diabetes Mellitus 3) Morbid obesity 4) COPD  5) Degenerative joint disease  6) Guillain-Barre syndrome.				Y					N	10/03/2006	10/06/2006	3	Numbness in feet symptoms and patient states she had EMG done and this was confirmed.  Labs and Diagnostics:  EMG on 10/26/2007.  Conclusion: Abnormalities mainly of the long tract studies which are mild in nature with, again, some prolongation of the F-wave studies and H-reflex consistent, which in and of themselves are not enough to make a diagnosis of Guillain-Barre but certainly would support the clinical findings of a mild, limited course of Guillain-Barre syndrome at this time. No other eveidence of radiculopathy, plexopathy, spinal stenosis, tumor, intrinsic neuromotor disease, peripheral impingement, or peripheral neuropathy at this time. Hospital admission labs reveal an unremarkable CBC and CMP significant for a glucose of 382 and a Hgb A1C of 13.2.  Alk. phos. elevated at 135.	OTH	PVT	Advair.  Meds: Advair 250/50, Combivent, Tramadol, and K+ supplementation.	NONE	Penicillin only. PMH:  Obesity, degenerative joint disease, COPD.  Allergies: Penicillin.			1						1	Arthralgia; Diabetes mellitus; Dizziness; Electromyogram; Guillain-Barre syndrome; Hypoaesthesia; Lethargy; Musculoskeletal pain; Pain in extremity; Pyrexia; Staphylococcal infection; Vomiting; Diabetes mellitus; Electromyogram; Guillain-Barre syndrome; Influenza; Pain in extremity; Staphylococcal infection; Walking aid user	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70737~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0271054	01/24/2007	NY	1.98	1	1	M	01/24/2007	The patient developed fever with seizure on the fourth day after he received the vaccine.				Y					Y	01/18/2007	01/21/2007	3		PUB	UNK						1						1	Convulsion; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0271058	01/24/2007		22.0	22		F	01/23/2007	Information has been received from a registered nurse concerning a 22 year old female with asthma, sulfonamide allergy, shrimp allergy and latex sensitivity who on 15-JAN-2007, in the morning was vaccinated with Pneumovax 23 vaccine (lot number 655152/0889F), intramuscularly in right lower deltoid. The patient was also given influenza virus vaccine (unspecified) concomitantly in the upper deltoid of the right arm. Concomitant therapy also included MACROBID, ORTHO-TRI-CYCLEN. On 15-JAN-2007, in the evening, the patient experienced temperature of 100.4 degrees F, redness, swelling and pain at injection site, On 16-JAN-2007, the patient was seen in the physician's office and the injection site reaction was described as red, swollen area with cellulitis measuring 4 cm that was painful to the touch. The patient also complained of muscle weakness, and could not lift the injection arm. On 17-JAN-2007 the patient was again examined in the physician's office and the cellulitis was measured to be 9 cm and was still painful and tender to touch. The patient also complained of generalized malaise and hip pain the preceding day. The patient continued to report a temperature of 100.4F but when the temperature was measured in the physician's office it was recorded to be 97.2F on 16-JAN-2007, and 98.2 on 17-JAN-2007. The patient is considered not recovered as of 17-JAN-2007. The physician's office is requesting a lot check. Cellulitis of the injection arm, hip pain, temperature of 100.4 degrees F, redness and swelling and pain of the injection site, generalized malaise and muscle weakness were considered disabling. Additional information has been requested.				Y				Y	N	01/15/2007	01/15/2007	0	body temperature 01/18/07 100.4 degrees, body temperature 01/16/07 97.6 degrees, body temperature 01/17/07 98.2 degrees	OTH	OTH	ORTHO TRI CYCLEN, MACROBID		Asthma, Sulfonamide allergy, Seafood allergy, Latex allergy		WAES0701USA02470	1						1	Arthralgia; Body temperature increased; Hypokinesia; Injection site cellulitis; Injection site erythema; Injection site oedema; Injection site pain; Injection site swelling; Malaise; Muscular weakness	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0889F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0271062	01/24/2007	ID	59.0	58		F	12/20/2006	Same day flu shot administered. Arm became itchy, from fingers to shoulder. This has continued to present day. Ibuprofen has only relieved pain for short periods of time.									N	11/24/2006	11/24/2006	0		PUB	UNK		NONE	NONE			1						1	Pain in extremity; Pruritus	FLU3~SANOFI PASTEUR~U2218AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0271063	01/24/2007	ID	52.0	51		F	11/19/2006	Patient received Pneumovax and flu shot in same arm. 1 IM 1 SQ. The SQ Pneumovax reacted with redness and swelling 8cm x 5cm Left upper arm. Some discoloration to purple also noted in this area. Area is hot to touch and very painful.				Y					U	11/16/2006	11/17/2006	1	NONE	OTH	OTH	Methotrxale, Metformin, Gamfibutzil, Etodalac	NONE	Rheumatoid arthritis, psoriatic dermatitis			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Skin discolouration	FLU3~SANOFI PASTEUR~U2279AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0188F~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0271064	01/24/2007	WA	73.0	73		F	11/17/2006	Dizzy, unable to walk, felt dogged.				Y					Y	11/15/2006	11/15/2006	0		PVT	PVT	UNK	NONE	NONE		ID06044	1						1	Abasia; Dizziness; Malaise	FLU3~SANOFI PASTEUR~U2252AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0271065	01/24/2007	ID	67.0	67		M	12/20/2006	After flu shot was received patient had a sore arm, soreness from fingers to shoulders.  Ibuprofen has relieved pain for short periods of time, pain has persisted to present day.									N	11/24/2006	11/24/2006	0		PUB	UNK		NONE	Sulfa drug allergies			1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2218AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0271066	01/24/2007	WA	56.0	56		M	01/07/2007	Patient describes got reaction like flu symptoms for almost 1 week, chest congestion, fever, body aches, shaking.									U	12/21/2006	12/22/2006	1	NONE	OTH	UNK	NONE	NONE	NONE			1						1	Influenza like illness; Pain; Pulmonary congestion; Pyrexia; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70739~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0271077	01/24/2007	NM	46.0	46		M	12/18/2006	BIGEMINY, TACHYCARDIA, PULSE 90-110 RESTING, SLIGHT CHEST PAIN.  1/25/07 Received medical records from hospital which reveal patient seen in ER 10/15/06 for chest pain which felt like constant burning.  Also had nasal congestion.  Tx w/antacid & d/c to f/u by PCP next day. FINAL DX: GERD & chest pain, non cardiac.									Y	10/12/2006	10/14/2006	2	NORMAL LABS: All labs were WNL including CK/MB & troponin.  H/H 12.0/36.8.  EKG was read as essentially WNL.	MIL	MIL	ADVIL	NONE	NONE PMH: thalessemia minor & atrial bigeminy	NONE~ ()~~0.00~Patient|NONE~ ()~~0.00~Sibling|NONE~ ()~~0.00~Sibling		1						1	Chest pain; Extrasystoles; Tachycardia	FLUN3~MEDIMMUNE VACCINES, INC.~500440P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0271078	01/24/2007	MT	2.0	2	.0	F	01/24/2007	Received influenza immunizations on 11/10/06 (Lot #U2255 AA given by LPN) and 12/21/06 (administered by RN).  She had very mild cold symptoms (slight rhinorrhea) early in January 2007.  On 1/13 she developed ataxia, fatigue and leg pain.  She had then progressive weakness and pain (legs/arms/back) and then frank refusal to bear weight.  She was hospitalized on 1/16/07. She had an LP and nerve conduction velocities done on 1/17.  LP with elevated protein and no pleocytosis and EMG revealed prologed nerve conduction velocities.  She was diagnosed with Guillain-Barre Syndrome and received 5 days of IVIG.  She was discharged on 1/24/07 still with weakness and refusal to bear weight, but her truncal ataxia was improved as was her pain.  She was discharged home on Neurontin and with physical therapy. 2/2/07 Received medical records from hospital which reveal patient experienced inability to walk, leg pain, hip pain, back pain, arm pain, malaise & constipation.  Patient had significant left hip pain w/touch or movement. Parents reported a couple of weeks prior to onset of s/s patient had mild URI in addition to having flu shot 1 mo prior.  Admitted 1/16-1/24/07 for probable toxic synovitis; constipation; & low grad emp.  Ortho consult done to r/u septic hip which was ruled out.  Neuro exam revealed areflexia by 1/17.  Tx w/5 course IVIG w/significant motor improvement.  D/C to home w/PT & to f/u w/PCP & neuro. FINAL DX: Guillain Barre Syndrome. No CSF labs or report of NCS included.  T/C to medical records.  Unable to locate.  Request refaxed. Per information received from annual follow up, she has recovered complete motor control. Still does not have reflexes in lower extremities bilaterally. She is still recovering. She is in physical therapy and has residual weakness in her legs.					Y	10			N	12/21/2006	01/13/2007	23	See #7 LABS: WBC on admit 11.8.  Sed rate 8. LP done 1/17 revealed protein 180, glucose 62, WBC 15.. NCS 1/18.  Urine & CSF cultures neg 4/10/07 Received CSF protein 180 & glucose 62 from hospital but they do not have EMG study. T/C to neurologist office.  No copy in office & office personnel unable to find in hospital records either but is aware that test was done.	UNK	UNK	None	None	None Birth HX: c section due to positioning.  Uncomplicated.	none~ ()~~0.00~Patient|none~ ()~~0.00~Sibling|none~ ()~~0.00~Sibling		1						1	Asthenia; Coordination abnormal; Culture urine negative; Electromyogram; Electroneurography; Fatigue; Guillain-Barre syndrome; Lumbar puncture; Nasopharyngitis; Pain; Pain in extremity; Rhinorrhoea; Weight bearing difficulty; White blood cell count	FLU3~SANOFI PASTEUR~U2255AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0271079	01/24/2007	NY	8.0	8		F	01/24/2007	hives, respiratory distress, lip swelling									Y	01/19/2007	01/22/2007	3	none	PVT	PUB	none	none	none			1						1	Lip swelling; Respiratory distress; Urticaria	FLU3~SANOFI PASTEUR~U2284AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0654F~2~IM~RA~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~1250F~3~IM~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0271080	01/24/2007	PA	0.8	0	.9	M	01/24/2007	After  booster flu shot was given,  a day later child had runny nose, and began itching. No previous cold.  Child has history of exzema.  Exzema was extrely mild at this time. Only region was ankles and under ears. Child became fussy, and exzema  was from head to toe.  Gross amounts on back and head. Also tiny red (pin size) dots were under chin, side of face, arms and small amounts were and still are on anus and on underside of penis and scrotum.  Dots will fade and come back and ezema is still extreme  ( breakage of skin from scratching) This has been going on for 1 and 1/2 weeks.  Administerd the generic form of Atarax, for itching. Lubricate child with over the counter Eurcin cream and a RX cream of Protopic.   1-24 gave child plain scramble egg.  After eating a few bites, child immediately threw up.  Allergies unknown at this time.  2/2/07 Received medical records from provider which real patient experienced thrush & diaper rash & was seen in ER on 1/6/07 for same.  Seen multiple times by PCP for rashes, facial puffiness & blotchiness.  Multiple trips to ER for same.  Multiple Rx w/steroids & Benadryl.  Skin infection 9/25/06.  OM & sinusitis/wheezing & possible pneumonia 12/06.   Continued antibiotics & was dx w/RAD.  Parent provided egg to patient on 1/24 & appears to have worsened eczema.  Continued on oral steroids & provided epi pen.  Counseled on diet restrictions. FINAL DX: allergic reaction to flu vax; allergic reaction most likely to eggs.									N	01/11/2007	01/14/2007	3	CXR ordered & reported as WNL.	UNK	UNK		No illness	Exzema, possible asthma PMH: Atopic dermatitis & eczema.  Strong family hx of allergies.	exzema~Influenza (Seasonal) (Flu-Imune)~~0.70~In Patient		1						1	Agitation; Eczema; Pruritus; Rhinorrhoea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~2~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0271087	01/24/2007	IL	22.0	22		M	01/24/2007	The subject is a nursing student who received the flu shot during a simulated disaster drill type process.  He received the flu shot on 10/26/2006 at 1215.  At 1230 he returned to the clinic area stating that he was lightheaded and nauseated.  He also stated that his righ arm had a tight feeling and was numb and tingling.  At 1240 his face became very flushed and hot to the touch.  He did not have and respiratory distress.  The occupational health physician said to send him to the ED or give him an epi-pen.  He refused the ED so an epi-pen was provided and administered at 1300.  After about 15 to 20 min his face became less red and hot to the touch.  His lightheadedness and dizziness got better as well as the arm numbness and tingling.  His father picked him up and took hime to his regular doctor for follow-up since he had refused going to the ED.  He returned to school on 10/30/2006 with a full doctor's release with no restrictions.				Y					Y	10/26/2006	10/26/2006	0	Pt stated no allergy to eggs prior to administration.  Since the reaction he has been tested by an allergist and found to have an allergy to fairly large quantities of eggs (>2eggs).	UNK	UNK	None	None	None	none~ ()~~0.00~In Patient|none~ ()~~0.00~In Sibling|none~ ()~~0.00~In Sibling		1						1	Dizziness; Food allergy; Hot flush; Hypoaesthesia; Nausea; Paraesthesia	FLU3~SANOFI PASTEUR~N/A~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0271091	01/24/2007	PA	56.0	56		F	01/24/2007	Prolonged arm pain > 4 weeks after injection. Patient did not move arm for 2-3 weeks. Subsequently developed signs of impingement syndrome with arm. We treated times one - Aleve.									N	11/02/2006	11/02/2006	0	MRI's of Shoulder and upper arm, no direct evidence of injury and underlying shoulder disease.	OTH	PVT	Elmiron	NONE	Allergic to Codeine			1						1	Hypokinesia; Impingement syndrome; Nuclear magnetic resonance imaging; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72207~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0271093	01/24/2007	CA	1.43	1	.4	F	01/16/2007	1/12/07 Left leg swelling on Saturday 1/18/07 started vomiting ER visit on 1/14 meds given for vomiting. Left leg swelling vomiting reducing.				Y					Y	01/12/2007	01/13/2007	1		PVT	PUB		NONE	NONE			1						1	Oedema peripheral; Vomiting	DTAP~SANOFI PASTEUR~C2489AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2200FA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE858AB~4~IM~RL~HIB (ACTHIB)~1	USA	Emergency room visit	Influenza
0271094	01/24/2007	CA	1.07	1	.1	M	01/24/2007	per pts parents, he vomited once on the day after vaccines were give. Currently he has some constipation, but feeding well. This is in follow-up to report(s) previously submitted on 2/13/2007. Information has been received from a physician concerning a 12 month old male with no know medical history or allergies who on  19-JAN-2007 at 08:30 was vaccinated SC in the right thigh witha a first dose of  ZOSTAVAX (lot# 654603/1405F) instead of PROQUAD.  Other concomitantvaccination given was the same  day included a fourth dose of PREVNAR(B08675D) given IM in the right thigh and a first dose of FLUZONE (lot# UT220PA) given IM in the left thigh. Illness at the time of vaccination inclkuded diaper rash and right lacrimal duct obstruction. Subsequently the patient developed constipation and threw-up once. Otherwise he was doing okay., she reported that he is an active mkid and no other changes were noted. The physician reported that the error was human error and not product confusion. The ZOSTAVAX  was stored in the same box as PROQUAD . The vial was picked up and administered to the patient without looking. The practice has since seperated the vaccines. Additional information from the physician indicated that the patient had no adverse events. No  further information is expected.										01/19/2007	01/19/2007	0	NONE	PVT	PVT		R Lacrimal duct obstruction, diaper rash.				1						1	Constipation; Vomiting; Wrong drug administered; Constipation; Inappropriate schedule of drug administration; Vomiting; Wrong drug administered	FLU3~SANOFI PASTEUR~UT2200PA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1008R~4~IM~LL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08675D~4~IM~RL~PNEUMO (PREVNAR)~1|VARZOS~MERCK & CO. INC.~1405F~1~SC~RL~ZOSTER LIVE (ZOSTAVAX)~1|FLU3~SANOFI PASTEUR~~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~MERCK & CO. INC.~1008R~UNK~~UN~HIB (PEDVAXHIB)~2|PNC~PFIZER\WYETH~~UNK~~UN~PNEUMO (PREVNAR)~2|VARZOS~MERCK & CO. INC.~1405F~UNK~~UN~ZOSTER LIVE (ZOSTAVAX)~2	USA		Influenza
0271100	01/25/2007	SC	4.0	4		M	01/24/2007	Right upper leg, red and swollen around site of dtap injection.  Vaccine given on 1/19/07, pt returned to ofice on 1/22/07. induration reddish patch RAT SK6 cm, with central bluish discoloration and diffuse margins, warm to touch, no fluctuation, no drainage.				Y					U	01/19/2007	01/19/2007	0	NONE	PUB	PUB	keflex 250 mg, motrin 100 mg	NONE	NONE			1						1	Erythema; Induration; Injection site discolouration; Injection site erythema; Injection site swelling; Injection site warmth	DTAP~SANOFI PASTEUR~AC14B040BA~5~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2249B~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB124BA~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0312F~2~SC~LL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA	Emergency room visit	Influenza
0271188	01/25/2007	NC	17.0	17		M	01/25/2007	Patient had well child exam 1/22/07, received Influenza vaccine, Hepatitis A, Menactra.  1/24/07 patient returned to clinic with complaints of  dizziness, headache, chill, green/yellow nasal drainage, bodyaches. Sites free from any s/s of infection or irritation/ VSS no temp.  Patien informed by PA-C to increase fluids, take tylenol/motrin for the bodyaches, RTC if sx increase or any other complication arise.									Y	01/22/2007	01/24/2007	2	influenza test - negative 1/24/07	UNK	UNK	none	none				1						1	Dizziness; Feeling cold; Headache; Influenza serology negative; Nasal mucosal discolouration; Pain; Rhinorrhoea	FLU3~SANOFI PASTEUR~U2215AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1209F~1~IM~LA~HEP A (VAQTA)~1|MNQ~SANOFI PASTEUR~U2116AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0271202	01/25/2007	TX	1.03	1	.0	F	01/25/2007	Temp of 104.7F, mom states that she called doctor and was told to give Tylenol and bath. Temp went down but later came back up to 103F. Later when child was at doctor's office, he told mom that it might have been the vaccine but she didn't have record with her for him to look at.									Y	12/21/2006	12/21/2006	0	NONE	PUB	OTH		NONE	NONE			1						1	Body temperature increased	FLU3~SANOFI PASTEUR~U2191CA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~1262F~1~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0271199	01/26/2007	MO	8.0	8		F	01/25/2003	Patient received PPV23 vaccine in L deltoid around 11AM and developed local swelling and redness around site. She also ran a fever that night to 104 and fever resolved after 36 hours. Patient also had myalgia and unable move Left arm until 2 days after vaccine. All symptoms resolved by AM of 1/24/07.				Y					Y	01/22/2007	01/22/2007	0	NONE	PVT	PVT	Biaxion 250mg started that day for sinusitis	Sinusitis-no fever	Perannual allergies with recurrent sinus infections; pneumonia in 2006.			1						1	Hypokinesia; Injection site erythema; Injection site swelling; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~0988F~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0988F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0271298	01/26/2007	LA	48.0	48		F		A report was received from a health care professional on 06/Oct/2006 concerning a 48 year old female vaccinee. No details of the vaccinee's past medical history or details of any concomitant medications were provided. Following vaccination with Fluvirin on 06 Oct 2006, the vaccinee experienced nausea and vomiting, with a severe headache and feeling hot. Further information will be requested. Follow up received from a healthcare professional on 16/Jan/2007. The vaccinee has a history of high blood pressure for which no medication is prescribed. The vaccinee's  previous surgical history includes, hysterectomy, C section, tonsillectomy and colonoscopy. On 06/Oct/2006 the vaccinee self medicated with Benadryl (OTC) for sinus pressure and Advil (OTC) for headache. On 06/Oct/2006, approximately 3 hours after receiving Fluvirin, the vaccinee experienced a severe headache which lasted for 2 days, (until 08/Oct/2006), vomiting, nausea, hot flashes and photophobia which all resolved the next day. The vaccinee was treated with intramuscular injections of Fecadron and Stadol/Vistaril. No further information is expected.								Y		10/06/2006	10/06/2006	0		UNK	UNK	Benadryl, Advil		The vaccinee has a history of high blood pressure for which no medication is prescribed. The vaccinee's previous surgical history includes: hysterectomy, C-section, tonsillectomy and colonoscopy.		CVOX200600120	1						1	Feeling hot; Headache; Hot flush; Nausea; Photophobia; Sinus headache; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69479~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0271299	01/26/2007	MI	0.68	0	.7	F	01/26/2007	Patient was found dead at home 1/26/07.  5/1/07 Received Autopsy Report which reveals COD as probable SIDS.	Y	01/26/2007							N	01/24/2007	01/26/2007	2		PVT	PUB		NONE	History of mild left facial paralysis at birth - resolved			1						1		FLU3~SANOFI PASTEUR~U2200KA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0271304	01/26/2007	MA	1.39	1	.4	M	01/05/2007	Erythema and warm. Anterior part of Left thigh about 5x7cm. Left inguinal lymph node.				Y					Y	01/03/2007	01/04/2007	1	NONE	PVT	PUB		NONE	NONE			1						1	Injection site erythema; Injection site warmth; Lymphadenopathy	FLU3~SANOFI PASTEUR~U2200KA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08675H~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0271306	01/26/2007	AR	41.0	41		F	11/22/2006	Had flu shot on 11/17/06. Stated site slightly sore and itchy on 11/18/06. Said bumped site while at work on 11/19/06 and since that time site swollen and red.				Y					U	11/17/2006	11/18/2006	1		OTH	PUB	NONE		Patient states history of skin problems			1						1	Injection site erythema; Injection site pain; Injection site pruritus; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA240AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0271307	01/26/2007	AR	46.0	45		F	12/12/2006	Right arm injection site became red, swollen, sore and warm to touch. Around 4 inches in diameter. Client took Ibuprofen and applied warm compresses.  Is completely better today.									Y	11/30/2006	11/30/2006	0	NONE	PUB	OTH	Synthroid	NONE	NONE			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2245AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0271311	01/26/2007	NJ	34.0	33		F	11/13/2006	Half an hour after administration, felt numbness in the mouth and difficulty swallowing and rash. Treatment-Benadryl, steroids (oral)				Y					Y	11/01/2006	11/01/2006	0	Oral Benadryl and oral steroids	PVT	UNK	Synthroid	NONE	Hypothyroidism, no known drug allergies.			1						1	Dysphagia; Hypoaesthesia oral; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71643~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0271330	01/26/2007	NM	5.0	5		M	01/26/2007	Patient treated on 1/13/07 at Urgent Care Center for complaining of erythema, edema extending from left outer upper thigh down 2 inches above left knee and to left inner thigh excluding posterior thigh.  Was treated with 2 days of antibiotic. Rash resolved within 3 days. On the fourth day parents noted bruising where the rash had been. Bruising has since resolved.				Y					Y	01/12/2007	01/13/2007	1	NONE	PUB	PUB	NONE	NONE	NONE	local edema~Vaccine not specified (no brand name)~~0.17~In Patient		1						1	Contusion; Injection site erythema; Injection site oedema; Rash	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B074AA~4~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72005~2~IM~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~MERCK & CO. INC.~AHAVB129AA~2~IM~RL~HEP A (VAQTA)~1|MMR~MERCK & CO. INC.~0427F~3~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0271336	01/26/2007	AZ	4.0	4		F	01/26/2007	Local reaction at immunization site.  Erythema and induration of 10 cm with firmness.  Non-tender									U	01/25/2007	01/26/2007	1		PUB	PUB						1						1	Injection site erythema; Injection site induration	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B040BA~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~SP42281AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~UNKNOWN MANUFACTURER~APZ0240~4~IM~LA~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0806F~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0271337	01/26/2007	MI	18.0	18		M	01/26/2007	Client sick to stomach within 30 minutes after receiving the vaccine.  Later developed red blotches on face and hands and generalized itching.  Given Benadryl 50 mg orally with diminishing of symptoms.  Vomited small amount of pinkish saliva/mucous about 5 minutes after the Benadryl was given.  Advised seek medical attention if symptoms recur and continue Benadryl for 24 hours.									Y	01/26/2007	01/26/2007	0		UNK	PVT	None	Mild cold	None			1						1	Abdominal pain upper; Erythema; Pruritus generalised; Rash macular; Vomiting	FLU3~SANOFI PASTEUR~U2187AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0271338	01/26/2007	DC	4.0	4		M	01/26/2007	Excessive redness/ swelling of thigh in region of vaccine administration				Y					U	01/24/2007	01/25/2007	1	none	PUB	PUB	tylenol	None	None			1						1	Injection site erythema; Injection site oedema	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B036CA~5~IM~RL~DTAP (INFANRIX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71032~2~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~V1032~4~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0497F~2~IM~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|VARCEL~MERCK & CO. INC.~0798F~2~IM~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0271355	01/26/2007	TX	58.0	58		F	12/25/2006	Fevers, chills, myalgia and diplopia.									N	10/17/2006	10/17/2006	0	Complete blood count	OTH	PUB	Lisinpril,		hypertension, stroke, thrombocytopenia, Depression, dilated cardiomyopathy, chronic renal insufficiency			1						1	Chills; Diplopia; Myalgia; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA210BA~1~~~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0674F~1~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0271356	01/26/2007	IA	90.0	90		M	01/26/2007	Patients wife phoned 11-3-06 said flu shot site reddened and swollen. Check up 11-6-06-redness lateral surface left arm; check up 11-9-06 redness Left posterior arm (abrasion); check up 11-14-06 left arm area healing nicely; check up 1-5-07 left arm posterior red. Note: Site of redness is not exact location of injection site.									U	10/12/2006	11/03/2006	22		PVT	PUB	Aricept, ASR, K-Dur, Lasix, Lisinopril, Prilosec, proscar.	NONE	Parkinson's Coronary artery disease. History prostate cancer.			1						1	Erythema; Excoriation; Injection site erythema; Injection site oedema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70091~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0271360	01/26/2007	CO	68.0	67		F	11/03/2006	NONE specified. 1/30/07 T/C to reporter to request missing info from Box 7 on VAERS form.  States patient had local reaction & hives.  Was seen only by her PCP & treated w/steroids & antihistamines & recovered completely within 2 wks.									Y	10/20/2006			NONE	OTH	PUB		NONE	NONE			1						1		FLU3~SANOFI PASTEUR~U2177AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0271344	01/27/2007	NY	86.0	86		F	01/27/2007	Both hands started swelling and hurt. Finger tips started loosing sensation making normal tasks like holding a glass, un-buttoning blouse, tying shoes, sorting vitamans and minerals, etc. This started the week of the vaccinations (one in each arm). This progressed and got worse over the month of November and on December 14th her Physician, a Holistic MD, made a house call.  1/29/07 T/C to reporter who is patients son.  States patient did not start on holistic meds until 1/07 due to not being available.  States patient has neither improved or worsened but remains about the same.  All s/s are in her hands/arms w/o difficulty ambulating.  States patient has not sought neuro consult & is waiting to see PCP when he returns from sabbatical on 2/6/07.  8/10/07 Received pcp medical records which reveal patient seen 11/16/06 after having received flu & pneumo vax 10/17 at outlying flu vax clinic.  Now w/left side paresis & discomfort at injection sites & numbness of both hand/fingers. 2-3 days s/p vax. Seen 12/14/06 w/continued peripheral neuropathy, decreased sensation to pin prick all extremities & leg spasms.  Advised to have Doppler study done but deferred.  Patient is homebound per son & physician made housecalls.  No neuro consult, no EMG/NCS studies were done.  FINAL DX: peripheral neuropathy & probable Guillian Barre syndrome.									N	10/17/2006	10/20/2006	3	Doctor made a house call on Dec. 14th, and diagnosed Gillian-Barre Syndrom and prescribed a concentrated broccoli extract (Baccolive) and Germanium. LABS: sed rate elevated at 35.	UNK	UNK		Patient was reasonably healthy for 86 years old	none			1						1	Guillain-Barre syndrome; Oedema peripheral; Pain in extremity; Sensory loss	FLUX~UNKNOWN MANUFACTURER~42213AA~1~ID~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~10490~1~ID~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0271357	01/29/2007	HI	5.0	5		M	10/12/2006	rash-red, macular with suspicious borders on face, arms, legs, back, abdomen.									U	10/11/2006	10/12/2006	1	NONE	PVT	PVT	NONE	NONE	Evans syndrome			1						1	Erythema; Rash; Rash macular	FLU3~SANOFI PASTEUR~U2237AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0271358	01/29/2007	HI	5.0	5		M	01/26/2007	Patient developed hives on face, arms, swelling around eyes. Benadryl given in office; patient sent to ER for EPI. Symptoms onset at minutes after shot.									Y	01/20/2007	01/20/2007	0		PVT	PVT		NONE				1						1	Eye oedema; Urticaria	DTAP~SANOFI PASTEUR~U13B7CA~5~~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2238AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0602F~2~~RA~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~Z0001~4~~LA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0271381	01/29/2007	FL	42.0	42		M	01/22/2007	Initial information received from a health  care professional on 19 January 2007. A 42-year-old male patient a first dose of Fluzone SV 2006-2007, lot number U2253AA, on 05 December 2006, the  patient developed numbness and tingling in his feet. By 17 December 2006, his back hurt and he was fatigued. He was seen in an emergency room the following day and was admitted to the hospital because he could not walk. On 20 December 2006, the patient was transferred to the intensive care unit (ICU) and was treated with immunoglobulins and plasmapheresis. His right side was paralyzed, and he was in severe pain. He was treated with Percocet. He was diagnosed with Guillain-Barre Syndrome. The patient has a past medical history of poorly controlled diabetes. On 03 January 2007, the patient was transferred to a rehabilitation facility after having been hospitalized for 16 days. His recovery status is unknown.  3/15/07 Medical records reviewed which reveal patient experienced tingling sensation & numbness of palms of hands & soles of feet.  Then lower leg muscles became weak & he became unable to walk.  S/S began 4 days prior to admit on 12/20/06-1/3/07.  Treated w/IVIG but continued to worsen.  Treated w/plasmapheresis, pain management consult & PT.  Improved s/p 5th session plasmapheresis.  D/C to rehab facility. FINAL DX: Guillian Barre Syndrome.				Y	Y	16			U	12/05/2006	12/09/2006	4	LABS: WBC 10.5, glucose 243 on admit.  CT & MRI of brain, MRI of thoracic & lumbar spines were WNL.   LP revealed glucose of 92 & total protein 269.	PVT	UNK	Unspecified Cholesterol and Diabetes meds		The patient has a history of diabetes. According to the reporting physician, the patient is not in good control of diabetes. He had never received an influenza vaccine prior to the one administered on 05 December 2006.		200700166	1						1	Abasia; Back pain; Fatigue; Guillain-Barre syndrome; Hemiplegia; Hypoaesthesia; Immunoglobulins; Pain; Paraesthesia; Plasmapheresis	FLU3~SANOFI PASTEUR~U2253AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0271385	01/29/2007	FL	61.0	61		F	01/15/2007	She had pain, the next day after the shot was done, on her left arm. The pain lasted 3 months. After that the pain started on her shoulder too. She is taking Tramaolol and Methylprednisdone. Per annual follow, hundreds of the same vaccine lot # and dose were administered without any negative complaints. Follow-up: Without further evaluation - one can not say with certain authority that this event was related to the Vaccine.			Y						U	10/17/2006	10/18/2006	1		PUB	PVT	NONE	NONE	NONE			1						1	Injection site pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69423~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~MASS. PUB HLTH BIOL LAB~TD165~UNK~IM~LA~TD ADSORBED (TDVAX)~1	USA	Life Threatening	Influenza
0271389	01/29/2007	TN	67.0	66		F	01/09/2007	1-5-07 Flu and Pneumonia admission in Right arm IM. 1-5-07 at health center patient reported to ER for bruising and redness on right upper arm. Patient was given steroid, antibiotic and Benadryl in ER. On 1-8-07 patient reported back to ER for complaining of tingling sensation from elbow to chest. Patient also states they're scared to sleep. Patient was given Valium. 1-8-07 in ER. Patient contacted health department today and states Valium didn't help. Patient referred to primary physician.				Y					U	01/05/2007	01/05/2007	0		PUB	PUB		NONE	NONE			1						1	Contusion; Erythema; Insomnia; Paraesthesia	FLU3~SANOFI PASTEUR~U2292AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0958F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U1734EA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0271392	01/29/2007	TN	0.89	0	.9	F	12/18/2006	12-14-06- redness, warm to touch, achy Left arm (lower deltoid); 12-15-06 warm(not hot to touch), red, edema. (red area measures approx 4.5x 2.5in) (edema approx 1.5x1in lower deltoid); 12-15-06 To ER, physician recommended Triamcinolone cream and told reaction to immunizations; 12-18-06 redness gone, arm better, no complaints.				Y					Y	12/12/2006	12/14/2006	2	Reaction to immunization	PUB	PUB		NONE	NONE			1						1	Erythema; Immunisation reaction; Injection site oedema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U2292AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~0958F~UNK~IM~LA~PNEUMO (PREVNAR)~1|TD~SANOFI PASTEUR~U1734EA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0271393	01/29/2007	TN	49.0	48		F	12/12/2006	Immediately after shot pain radiated from left deltoid region to elbow to hand. Patient had difficulty moving arm. Around 3 pm noticed slight swelling in that hand.									U	12/12/2006	12/12/2006	0	NONE	PUB	UNK		Sinus infection 2 weeks prior	Diabetes			1						1	Hypokinesia; Injection site pain; Oedema peripheral	FLU3~SANOFI PASTEUR~U2239AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0271396	01/29/2007	MI	58.0			M	01/17/2007	Subcutaneous firm mass at injection site.									N					OTH	PVT		NONE				1						1	Injection site mass	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0271398	01/29/2007	MI	35.0	35		F	01/09/2007	left arm swelling up to neck.  Recommended to use ibuprofen									N	01/04/2007	01/05/2007	1		PVT	PVT		NONE				1						1	Swelling	FLU3~SANOFI PASTEUR~U2248AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0271402	01/29/2007	CA	66.0	65		F	01/16/2007	Tender feet (bottom of feet) onset 3 days after injection. Muscle weakness in arms and legs (dibiliting) 03/13/07-records received from PCP for DOS 11/27/06-02/01/07-Assessment:paresthesias of left hand. probable carpal tunnel syndrome. Myalgias. Hypertension. Hyperlipidemia. Rosacea. Osteoarthritis. C/O sense of weakness and pain in limbs. Seen by chiropractor in October or November.  PE:WNL.				Y					U	11/25/2006	11/28/2006	3	NONE Labs received 3/13/07-C-reactive protein 0.5. Nerve conduction studies 1/5/07-study normal of lower extremities.X-ray of shoulders:bilateral should arthritis with a type II acromion, right greater than left. Cervical spondylosis. Lumbar spondylosis and a bony fusion. MRI of lumbosacral spine 1/16/07 disk bulge at L2-3 facet arthrosis, some neuroformainal narrowing at various levels but no cord or significant canal or neuroelement compromise. MRI 1/3/07 cervical spine small disk bulge at C7 without spinal cord abnormality or neuroelement compromise.	OTH	PVT	Lipitor, Tricor	NONE	NONE Records received:03/13/07-PMX:hyperlipidemia, rosacea, hypertension, osteoarthritis and possible diabetes mellitus.			1						1	Muscular weakness; Tenderness	FLU3~SANOFI PASTEUR~U2255AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0271403	01/29/2007	IN	4.0	4		F	12/28/2006	This is a 4-year-old white female who presents to the emergency department after having a flu shot and was started on Premarin cream today for labial effusion.  Second dose was at 10:30 p.m. About 45 minutes later the patient complained of being cold with her legs hurting, throat hurting, having headache and chills according to the mom.  She had no fevers. She has had no rash or wheezing. No hives, and now all has completely returned to normal with no complaints at all.				Y					Y	12/15/2006	12/15/2006	0		PVT	OTH		NONE	Keflex, Sulfa			1						1	Chills; Headache; Nasopharyngitis; Pain in extremity; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U2292AA~3~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0271405	01/29/2007	OR	6.0	6		M	01/25/2007	Rt arm swelling and fever within 24 hours of vaccine, newly diagnosed, type I diabetes mellitus, on insulin for only 1 mo. Fever persisted x 24 hours but swelling decreased. Mother gave benadryl and fever med. Doing much better 48 hours post vaccine.									Y	01/23/2007	01/23/2007	0	Called pvt endocrinologist but no tests necessary	PUB	PUB	LPH, Novalog	NONE	Type I IDDM		OR200703	1						1	Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U2281AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0620F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0271410	01/29/2007	MS	50.0	49		F	01/22/2007	Talked with patient on 1/22/07. Patient said her arm was sore after taking the Flu shot, but soreness had gone away until she started working out. She said she had problem,s lifting her dumbbells. She also said she had problem putting her coat on. She says it doesn't bother her unless she lifts weights. Shot was given on 11/2/06 by a Nursing Student from Nursing School. She is just reporting this to the health department. Patient has not been to see MD for this problem. I instructed patient to see MD asap for evaluation. When I asked patient why she waited this long she said her husband kept telling her that it's ok and it will get better. I instructed her to see MD asap and not to wait any longer. When I asked patient if there was any redness, swelling or heat coming from her arm she said No.									U	11/02/2006	11/05/2006	3	NONE	PUB	OTH	UNK	NONE	NKA			1						1	Hypokinesia; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71826~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0271417	01/29/2007	NM	4.0	4		M	01/23/2007	Client father contacted this office per phone 1/8/07 and stated his son who seen in ER over the week end an area on left arm swollen and reddened. Stated son itched and scratched area and doctor at ER told him to find out which vaccine as may had allergic reaction. Asked Client to bring child to office to observation as 2 vaccine given on left arm. MMR and DTaP. Client did not return with child 1/8, 1/9 or 1/10/07.				Y					U	01/05/2007	01/06/2007	1	NONE	PUB	PUB	DTap, MMR and Fluzone	NONE	NONE			1						1	Allergy to vaccine; Erythema; Oedema peripheral; Pruritus; Scratch	DTAP~SANOFI PASTEUR~C2650AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2177AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0807F~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0271431	01/29/2007	OH	46.0	46		F	10/26/2006	States had sore arm..Had six dime size red spots across upper arm - not elevated. Denies any breathing difficulty or burning, tingling of tongue, throat or lips since getting injections.  She had requested both injections in same arm due to diabetes and having to self inject insulin.  Instructed to apply cool compresses, take Tylenol or Ibuprofen for pain and Benadryl as directed on box.									Y	10/24/2006	10/24/2006	0	none	PUB	UNK	Novulog/Lantus Insulin/Nasal Spray	none	Diabetes			1						1	Erythema; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70277~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1048P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0271433	01/29/2007	OH	41.0	43		F	11/07/2006	Patient called at 1430 stating development of approx 20 hives on face, arms, chest, and belly within one hour of receiving flu shot.  Took Allergan and Ventolin Inhaler at 1030 and inhaler again at 1430.  Chest feels tight (like asthma), denies numbness or tingling in lips or tongue.  Encouraged Benadryl (if able to take it) and if sx not resolved by hs encouraged ER/Ambulance for difficulty breathing and/or numbness or tingling of lips, tongue, etc.									Y	11/07/2006	11/07/2006	0	none done	PUB	PUB	Allegra prn/Ventolin inhaler prn	denies	environmental allergies (seasonal) and asthma			1						1	Asthma; Chest discomfort; Urticaria	FLU3~SANOFI PASTEUR~U2286AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0271436	01/29/2007	OH	50.0	50		F	01/29/2007	Pain radiating down left arm to hand on certain movements. Started about 1 week after vaccination. Still has pain									U	11/14/2006	11/20/2006	6	none	PUB	PVT	none	none	Pt. mentioned that in the last year she had pain radiating down RT arm to hand from pulled muscle.  She stated the pain remained for 8 months.			1						1	Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71640~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0271444	01/29/2007	SC	64.0	64		F	01/29/2007	Throbbin pain at injection site and arm feels heavy since receiving flu shot.  States this occurred also in 2 previous years after having received flu shots.  Instructed to see her private MD									U	12/11/2006	12/17/2006	6	NONE	PUB	PUB	NONE	NONE	Allergies to penicillin, bee stings		SC0631	1						1	Injection site pain; Sensation of heaviness; Similar reaction on previous exposure to drug	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71032~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0271448	01/29/2007	UT	0.58	0	.6	F	01/29/2007	Seizure roughly 1 per day that lasts from anywhere from a few seconds to up to 15 minutes.  She both jerks her head slightly and stares.  This started roughly 11 days after she was vacinated and has never occurred prior.  2/2/07 Received medical records from provider which reveal patient was well on day of vax 1/11.  Next vs was on 1/25 when parent provided videotape of seizure like symptoms of  eyes suddenly opening wide, both arms symmetrically extending up & out at shoulders w/episode lasting 1-2 seconds recurring several times per day for 3 days.  Referred for EEG, possible MRI if EEG is abnormal FINAL DX: GERD & possible convulsions.				Y					N	01/11/2007	01/22/2007	11	She will be getting an EEG and an MRI soon at Hospital.	UNK	UNK	None	None	None PMH: GERD			1						1	Convulsion; Dyskinesia; Staring	DTAP~UNKNOWN MANUFACTURER~Unknown~3~IM~RL~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~Unknow~2~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~Unknown~2~IM~RL~POLIO VIRUS, INACT. (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0271455	01/29/2007	ME	49.0	49		F	01/29/2007	Fever to 39 degrees C (positive), severe headache, delusions, red, swollen injection site.  2/6/07 Received medical records from hospital which reveal patient experienced fever & delirium s/p pneumovax & flu vax.  Admitted from 1/24-1/28/07.  Exam revealed confusion. Admit dx was pneumonitis & was started on IV antibiotics.  Fever resolved & developed warmth & erythema of right arm w/pain on motion right shoulder which improved w/Benadryl.   FINAL DX: Fever w/o source; possible inflammatory response to Pneumovax immunization vs Flu vax.				Y	Y	4			Y	01/23/2007	01/23/2007	0	Blood, Cerebrospinal fluid, urine cultures-all negative  LABS: admit WBC 18,000.  CXR showed early infiltrate in RUL & LUL.  CT of head was WNL.  LP done & reported as WNL but no actual report provided.  All c/s were neg.	PVT	UNK	Premarin, Prolonix, Celebres, Albuterol	NONE	Egg intolerance (GI upset), latex allergy PMH: chronic depression; reformed smoker; history of ETOH abuse until 2002. ALLERGIES: Eggs.			1						1	Blood culture negative; CSF culture negative; Culture urine negative; Delusion; Headache; Injection site erythema; Injection site swelling; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA239CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0988F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0271465	01/30/2007	GA	25.0	25		M	01/30/2007	Varicella outbreak/rash: multiple erythematous papules and multiple vesicles with erythematous borders to scalp, face, trunk, upper extremities and buttocks. Treatment: isolation. 03/26/07-records received from facility for DOS 01/27-01/30/07 DC DX: Viral illness. Received Varicella vaccine 1/16/07, after negative titer-2 weeks later developed rash with typical dewdrop on rose petal type of morphology. Pruritis. Admitted for isolation due to basic training status and concern for contagiousness.					Y	5			Y	01/16/2007	01/24/2007	8	Negative varicella titer before varicella vaccine given.	MIL	MIL	Bicillin LA 1.2 MIL Units (11 Jan 2007)	None	None	None~ ()~~0.00~Patient|None~ ()~~0.00~Sibling		1						1	Blister; Patient isolation; Rash erythematous; Rash papular; Rash vesicular; Varicella	FLU3~SANOFI PASTEUR~U2259AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB068BC~1~IM~LA~HEP A + HEP B (TWINRIX)~1|VARCEL~UNKNOWN MANUFACTURER~~UNK~~~VARICELLA (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0271470	01/30/2007	CA	12.0	12		F	01/30/2007	Child attended Karate class and instructor was tapping the injection not knowing that the child had received immunizations the day before.  Red swollen the size of a baseball at site of injection on right deltoid.  Area was tender to touch.									Y	01/24/2007			None	MIL	MIL	None	Seeing provider for eczema	eczema  no allergies noted			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2310AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0868F~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2209AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0271471	01/30/2007	FL	68.0	68		M	01/30/2007	01/10/07 Came to receive a Flu vaccine.  Used lot #U2285AA in Rt. Deltoid.  Came today 1/30/07 stating that Rt. Shoulder and forearm has been hurting since vaccine given.  Pt. c/o having pain on posterior area of Rt. Deltoid muscle area.  No mass, no redness or warm to area.									U	01/10/2007	01/10/2007	0	Possible inflammation reaction(local).  X-ray to Rt. shoulder.  RX. given to Pt.	UNK	UNK	None reported	None reported	NKDA, None reported, States he is very healthy. Previous prostate problems.			1						1	Inflammation; Musculoskeletal pain; Pain in extremity; X-ray	FLU3~SANOFI PASTEUR~U2285AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0271487	01/30/2007	IN	0.61	0	.6	F	01/24/2007	Flu vaccine given 12-9-05, seen in ER 12-21-05 for seizures - staring and jerking which mom now realizes started shortly after flu vaccine given. Has been followed by Neuro. Test reveal no cause for delay and hypotonia.    02/21/2007 MR received from PCP. PMH:  Well baby exam of 09/26/2005 all WNL. Developmental delays noted at 6 month check 11/09/2005. Not feeding self, no transfers, not holding bottle, not using sippy cup. DTap and IPV given.  Flu shot 12/09/2005-reportedly doing well.  OV on 12/16/2005 for c/o strange eye movements and jerking lasting a minute or so, 1-2 times/day.  Assessment: R/O seizures. Developmental delay. 03/20/2007 MR received for initial hospital visit for seizure activity on 12/18/05.  Following her Flu vax. mother reported that the child was having  episodes where her eyes would move up in her head, eyelids would flutter, and jerking.  No prior history of fever, but ER temp was 100.8'F. Treated with Ativan and Cerebyx with no further seizures.  Discharge after a 2 night stay.  PE WNL except for: microcephaly-head circumference 39.7cm which is <5th percentile.  Anterior fontanelle only admits tip of finger. No social interaction noted.  No visual tracking.  No response to loud noise.  upon pull to sit, child does not try to maintain position or use hands for support. Final Diagnoses:  Infantile Spasms.  Seizure Disorder.  Developmental Delay. F/U for ER visit on 12/21/2005 for seizures. Now on Topamax. 9 month check(02/10/2006) with Assessment:  Developmental Delay, Seizure disorder. Weight loss noted at 12 month check (4/21/06).  Has not met any developmental milestones. Head lag.  Hypotonia.  Additional Assessment:  Failure to Thrive. Two consultations sent with medical record.  06/06/2006: Child was seen for evaluation of poor weight gain in the context of seizure disorder and severe developmental delay. Marked regression since onset of seizures in 12/2005. Impression:  Severe developmental delay with history of developmental regression after severe seizure at 7 months of age.  Swallowing dysfunction.  Failure to Thrive, likely due to swallowing dysfunction or to underlying metabolic disorder. Nourishment via NG tube.  PE shows fluctuating tone in all extremities. Diagnoses: 1) Feeding dysfunction. 2) Microcephaly. 3) Seizures. 4) Delayed milestones./pc 03/08/2007 Hospital record received for 4 day inpatient stay 06/12/2006-06/16/2006 for admission DX of: 1) Failure to thrive.  2) Severe global developmental delay.  3)  Seizure disorder.  4) Hypotonia.  5)  Microcephaly. Pt. was admitted for further evaluation of the above disorders due to no weight gain over a 3 month period. Genetics consult felt that the patient's condition was highly suggestive of an inborn error of metabolism, however parents declined any further testing and a DNR was signed and the child placed under hospice care. Discharge DX same as admission. Consult in Developmental Pediatrics 01/05/2007.  Improvement noted.				Y	Y	7		Y	U	12/09/2005	12/09/2005	0	Testing for in-born errors of metabolism, CBC, cultures, EEG, MRI. Labs and Diagnostics:  Brain MRI shows thinning of the Corpus Collosum and prominent bifrontal extra axial spaces.  Head CT shows questionable cortical atrophy around the frontal left temporal lobes.  EEG was markedly abnormal with disorganized background rhythm suggestive of underlying cerebral dysfunction. Chromosome analysis shows a normal female karyotype.  Otoacoustic emission test was passed.  UA WNL.  CSF culture-no growth. CSF WNL UC-no growth.  CBC with WBC of 20.46.  Amino Acid tests do not suggest a specific inherited metabolic defect. Labs and Diagnostics:  EEG 6/13/06-Grossly abnormal.  MRI 6/15/06 shows cerebral volume loss and delayed myelination.  Myelination has progressed since exam of 12/19/06 however not to the extent expected.	PVT	PUB	None at that time.  Meds:  none noted.	NONE	Head small for age-5th percentile. PMH: Twin.  Developmental delays:Normal development until 6 months of age, otherwise healthy. Parents are 1st cousins.  Allergies:  None.			1						1	Convulsion; Culture; Dyskinesia; Electroencephalogram; Full blood count; Hypotonia; Metabolic function test; Nuclear magnetic resonance imaging; Staring	FLU3~SANOFI PASTEUR~U1765FA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0271491	01/30/2007	IN	69.0	69		F	01/30/2007	Daughter called 12-20-06 claims mother complained of pain in left arm.  Spoke with nurse practitioner who told her to use cold compressions and motrin on 1-4-06, also to come by after to check site. Husband claims pt is in therapy for shoulder pain.									N	12/15/2006	12/28/2006	13	NONE	PVT	PVT	UNK	NONE	UNK			1						1	Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71211~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0271498	01/30/2007	OR	6.0	6		F	01/25/2007	blotching red itchy urticaric rash, flushed cheeks, puffy, warm ears (w/o other known cause for allergic like response)				Y					Y	01/22/2007	01/23/2007	1		OTH	OTH	NONE	NONE	NONE			1						1	Erythema; Feeling hot; Flushing; Hypersensitivity; Rash macular; Swelling face; Urticaria	FLU3~SANOFI PASTEUR~U2252AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0271503	01/30/2007	NY	5.0	5		F	01/25/2007	vaccine administered 1/23/07-no initial reaction.  Today 1/25/07 RA red, swollen, warm to touch, itchy down to elbow.									Y	01/23/2007	01/25/2007	2		PVT	PUB	NONE	NONE	NONE			1						1	Injection site erythema; Injection site oedema; Injection site pruritus; Injection site warmth	FLU3~SANOFI PASTEUR~U2285AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~2034~4~~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1531F~2~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0271505	01/30/2007	OK	23.0	23		M	01/22/2007	Received call from instructors , found patient lying on ground, assessed airway, given 2 doses of Epi-pen, given IV, stayed with patient. Until EMS arrived. 01/31/07-records received and reviewed. Patient seen in follow-up to ER visit, no records available. Received 7 immunizations day prior to visit. HX of treatment at ER, did not receive epinepherine but some other type of IV medication. Allergic to PCN, zithromax. No complaints at the time of office visit. Did not take Benadryl, slept all night.  PE:WNL.  Assessment:other specified adverse effects not elsewhere classified. Patient had 7 immunizations unknown which was offending agent.				Y					U	01/22/2007	01/22/2007	0	NONE	MIL	MIL	UNK	NONE	PCN, Amoxicillin, Zithromax			1						1	Loss of consciousness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA243BA~1~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB068AA~1~IM~~HEP A + HEP B (TWINRIX)~1|IPV~SANOFI PASTEUR~Z00182~1~SC~~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1026F~1~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1|MNQ~SANOFI PASTEUR~U1922AB~1~IM~~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B011CA~1~IM~~TDAP (BOOSTRIX)~1	USA	Emergency room visit	Influenza
0271499	01/31/2007	AK	44.0	44		F	01/19/2007	1/16/07 6 pm sore arm left deltoid. 1/17/06 early morning-redness, soreness left deltoid felt tired all day. 1/18/07 early morning-felt sweating, cold, chills. Notice 3 red spots 1- 1 1/2 inch and the other 2- 1inx1in. Warm to touch and tender under arm in arm. 1/19/07 arm feels better left arm is sore.									Y	01/16/2007	01/16/2007	0		PUB	PUB	NONE	NONE				1						1	Chills; Fatigue; Hyperhidrosis; Injection site erythema; Injection site pain; Nasopharyngitis; Skin warm; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA231AA~1~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0880F~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0271500	01/31/2007	AK	42.0	41		F	01/19/2007	1/16/07 6 pm arm sore. 1/16/07 7pm felt sick, chills, light headed, no appetite, could not get warm. Chills, Temp 102F, drank tea began sweating. 1/17/07 went to hospital early morning. 1/17/07 observed red patch 3.5x2 inch warm to touch, tender when touch.				Y					U	01/16/2007	01/16/2007	0		PUB	PUB	NONE	NONE				1						1	Body temperature increased; Chills; Decreased appetite; Dizziness; Erythema; Malaise; Pain in extremity; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA231AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|MUR~MERCK & CO. INC.~0880F~1~~LA~MUMPS + RUBELLA (FOREIGN)~1	USA	Emergency room visit	Influenza
0271501	01/31/2007	CA	2.0	2	.4	M	01/30/2007	Hives. Zyrtec, Epi.				Y					Y	01/30/2007	01/30/2007	0		MIL	MIL		Cold				1						1	Urticaria	FLU3~SANOFI PASTEUR~U2174GA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1280F~2~IM~RL~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0271539	01/31/2007	PA	89.0	89		F	01/27/2007	The next morning fingers swelled and pain on arm of shot, went across chest into other arm. Starting to effect severe pain and swelling every muscle and  joint in body. Unable to walk or pick up any object with arms. Low fever.  2/2/07 Received medical records from PCP which reveal patient seen 1/17/07 for diffuse muscle pain.  Had been evaluated in early Nov for complaints of leg pain & dx then with arthritis of hips & lumbar spine.  Started PT but got progressively worse with pain extending to arms with severe muscle pain & stiffness of neck, shoulders, arms & lower legs, esp worse in mornings.  Patient had unexplained weight loss of about 5 #.  Exam revealed diffuse muscle tenderness to palpation and unsteady gait requiring use of assistive device.  Tx w/steroids & if no improvement was to be referred to rheumatology.  Daughter related that patient received flu shot at pharmacy which reported to daughter they had 15-17 cases of serum sickness reaction from same lot. FINAL DX: possible serum sickness reaction; although polymyalgia rheumatica type syndrome was felt to be more likely. Per information received from the annual follow up: Unable to walk, hospitalized 3 times for a week or more each time, High Sed Rate, inflamation over entire body. Blind one eye from inflamation ever since flu shot. Yes, I believe this company that made this vaccine should be shut down or prohibited from making any more vaccines. There were other people this happened too. My mother is dying from their mistake and carelessness. She was active, driving a car, doing laundry, cleaning, perfect state of mind, cooking. 48 hours after flu shot this all started and just keep getting worse. She will die from vaccine. My mother's age had nothing to do with this. I received papers from other people in the 40's, 50's, 60's, that had a severe reaction from this company's vaccine. You go get the flu shot to protect you from getting the flu and the shot itself kills you from this company, that is still making vaccine and not brought to justice. What they put in that lot no. vaccine, no one will ever know and it cause such pain and agony and sickness in a person is horrifying. It discusses and hurts me to know this company is still in business. This started 48 hrs after that flu shot and just getting worse. My mother was completely healthy before that shot.			Y	Y				Y	N	10/25/2006	10/26/2006	1	Blood work, Sed rate high, Showing inflammation.  LABS: xrays done after November office visit revealed mod to severe osteoarthitis of hips, worse on left. CRP elevated at 2.8.  Sed rate elevated at 80.	OTH	PVT		NONE	NONE PMH: arthritis, unexplained weight loss			1						1	Abasia; Abnormal loss of weight; Arthralgia; Blindness unilateral; Blood test; Body temperature decreased; Hypokinesia; Injection site pain; Joint swelling; Muscle swelling; Myalgia; Oedema peripheral; Pain in extremity; Pyrexia; Red blood cell sedimentation rate increased; Arthralgia; C-reactive protein increased; Musculoskeletal stiffness; Myalgia; Osteoarthritis; Pain in extremity; Polymyalgia rheumatica; Red blood cell sedimentation rate increased	FLU3~SANOFI PASTEUR~U2213AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2213AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Disabling	Influenza
0271548	01/31/2007	CA	1.32	1	.3	F	01/31/2007	RIGHT THIGH SWOLLEN, RED AND WARM TO TOUCH SINCE VACCINES WERE GIVEN ON 01-24-07.  TYLENOL AND WARM COMPRESSES GIVEN BY MOTHER.  PER DR. DIAGNOSIS IS RIGHT THIGH CELLULITIS 2ND TO REACTION TO DTAP VACCIN.  MOTHER TO CONTINUE WARM COMPRESSES AND GIVE MOTRIN.									Y	01/24/2007	01/25/2007	1	NONE	UNK	UNK	PT ON PHENOBARBITOL	NO	SEIZURE DISORDER			1						1	Cellulitis; Injection site erythema; Injection site swelling; Injection site warmth; Vaccination complication	DTAP~SANOFI PASTEUR~C2552AA~4~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2200PA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1124F~4~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~BO8666B~4~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0271550	01/31/2007	KY	31.0	31		F	01/31/2007	Pt presented with HIVES and itching after Flu Vaccine given about 20 minutes after vaccine.Pt given 50 mg IM of Benadryl.  Pt monitored for 30 minutes after reaction.  Pt ambulated to vehicle, husband drove home, no further problems.  Counseled on S/SX to watch for and when to present to ER.									Y	01/26/2007	01/26/2007	0		UNK	PVT	Blood Pressure medication		Hx of tachycardia			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2279AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269066	02/01/2007	NY	83.0	83		F	01/16/2007	This case was reported by a physician and described the occurrence of arm tremor in an 83 year old female subject who was vaccinated with FluLaval for prophylaxis. Concurrent medication included Enalapril, Atorvastin calcium, Warfarin sodium, Lexapro. Losartan potassium, Oxybutynin hydrochloride and Donepezil hydrochloride. On 28 November 2006, the subject received a dose of FluLaval intramuscularly in the left deltoid. On 02 December 2006, four days following vaccination with FluLaval, the subject experienced left arm tremor. The outcome of the event was not reported. Follow-up information received on 02 January 2006 indicated that the event resolved by 09 December 2006. In the reporter's opinion, the event was related to treatment with FluLaval.									Y	11/28/2006	12/02/2006	4	UNK	PVT	PVT	Enalapril Atorvastatin calcium Warfarin sodium Lexapro Oxybutynin hydrochloride Donepezil HCl Losartan potassium				A0630982A	1						2	Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601211~UNK~IM~LL~INFLUENZA (SEASONAL) (FLULAVAL)~2	USA		Influenza
0271570	02/01/2007	GA	13.0	12		M	01/26/2007	Fever, rash face, neck, chest, legs, hands, sore throat, See attached office notes and Hosp D/C. DC Summary 11/18/-11/19/06. DC DX Streptococcal pharyngitis, leukocytosis, disorder volume depletion, dehydration. Chronic ITP with complaints of fever, sore throat rash and petechiae s/p splenectomy prior to vaccines					Y				Y	11/14/2006	11/16/2006	2	See Attached CBC	PVT	PUB	See attached Albuterol		Thrombocytopenia, Asplenic.  Splenectomy			1						1	Full blood count; Pharyngolaryngeal pain; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U2187AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1908AA~1~~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Hospitalisation	Influenza
0271573	02/01/2007	AR	44.0	44		F	11/29/2006	11/16/06 flu vaccine 1:10 am flu clinic, left arm numbness started about 5-10 min later whole arm. Seen by doctor 11/22/2006 numbness lasted or more than 13 days from elbow completely numbness				Y						11/16/2006	11/16/2006	0	left arm, chest wall pain and chest numbness	PUB	UNK		NONE	NONE		AR0711	1						1	Hypoaesthesia; Musculoskeletal chest pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFluA240AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0271574	02/01/2007	AR	59.0	59		F	12/01/2006	pt complained off sharp pain upon injection followed by severe pain for 3 days after injection until present				Y					U	11/27/2006	11/27/2006	0		PUB	PUB	Benicar, Premarin, HCT		Hypertension, Sleep apnea		AR079	1						1	Injection site pain	FLU3~SANOFI PASTEUR~U2192AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0271575	02/01/2007	DE		1	.0	M	01/23/2007	Urticarial-like rash beginning day after shots and worse at night 3d later, no resp. difficulty. Lesions did not wax/wane. Most rash is on legs/abdomen; also on arms and torso.  2/22/07 T/C to reporter & call returned.  States patient seen x 2 since report submitted.  Yearly labs done 2/8 were WNL.  seen 2/19 & had continued rash.  Continued treatment w/Benadryl.  Seen on 2/21 for continued mild scattered rash now diagnosed as mild eczema & left occiput adenopathy.  Afebrile & developmentally on target.  No other symptoms.									U	01/19/2007	01/19/2007	0		PVT	PUB		NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~UT21755EA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0604F~2~IM~LL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~1118F~2~SC~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0271589	02/01/2007	TX	8.0			M	01/16/2007	This case was reported by a healthcare professional and described an 8-year-old male subject who was inadvertently vaccinated with FluLaval and experienced queasiness. On 25 October 2006 the subject received unspecified dose of FluLaval. FluLaval is recommended for immunizing individuals 18 years and older. Follow-up was received on 27 October 2006 from the reporting healthcare professional. The subject had no pre-existing medical conditions. Information regarding previous immunization with influenza virus vaccine was not provided. The subject received FluLaval at 2:00 pm on 25 October 2006. At approximately 5:30 pm on 25 October 2006, three and one-half hours following the administration of FluLaval, the subject experiences queasiness and fatigue. The subject vomited the evening of 25 October 2006. The subject was seen at a  physician's office. The events resolved on an unspecified date on or after 25 October 2006 and on or before 27 October 2006. The healthcare professional considered the events unlikely to be related to vaccination with FluLaval.				Y					Y	10/25/2006	10/25/2006	0	UNK	OTH	OTH		UNK	The subject had no pre-existing medical conditions. The subject's concurrent conditions and concurrent medications were not reported. The healthcare professional reported that one other subject inadvertently received a dose of FluLaval. Please see case A0624950A.		A0624953A	1						1	Fatigue; Inappropriate schedule of drug administration; Nausea; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601011~UNK~~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0271590	02/01/2007	FL	29.0	29		F	01/16/2007	This case was reported by a healthcare professional and described the occurrence of itchy legs in a 29-year-old female subject who was vaccinated with FluLaval for prophylaxis. The subject had no pre-existing medical conditions. There were no concurrent medications. The subject had received influenza virus vaccine previous years with no subsequent events. On 25 October 2006 at 7:00 am, the subject received unspecified dose of FluLaval in the left thigh. On 25 October 2006 at 7:00 pm, 12 hours after vaccination with FluLaval, the subject experienced itchy legs. The subject was seen at a physician's office. The subject was treated with mineral oil (Baby oil). At the time of initial reporting, 30 October 2006, the event was ongoing. The healthcare professional considered the event was unrelated to vaccination with FluLaval.				Y					N	10/25/2006	10/25/2006	0	UNK	PVT	PVT	No concurrent medication	UNK	The subject had no pre-existing medical conditions. The subject's concurrent conditions were not reported.		A0625255A	1						1	Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F600911~UNK~~LL~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0271591	02/01/2007	TN	27.0	27		F	04/12/2007	This case was reported by a healthcare professional and described the occurrence of injection site redness in a 32-year-old female subject who was vaccinated with FluLaval vaccine during an unspecified trimester of pregnancy. The subject's medical history included a tattoo just above the injection site. On 06 November 2006 the subject received unspecified dose of FluLaval at an unspecified injection site. On or after 06 November 2006 and on or before 08 November 2006, less than one week after vaccination with FluLaval, the subject experienced injection site redness. The reporter noted that the subject has a tattoo just above the injection site. The healthcare professional reported that the subject was pregnant at the time of the FluLaval administration. The trimester of pregnancy, date of last menstrual period and estimated date of delivery were not reported. At the time of initial reporting, 08 November 2006, the injection site redness was ongoing. The healthcare professional considered the injection site redness to probably be related to vaccination with FluLaval.  Follow-up information was received from the reporter on 02 March 2007.  The subject's medical history included one previous pregnancy that resulted in spontaneous loss.  Concurrent medication included prenatal vitamins (Duet with DHA) one soft gel tablet daily beginning 29 March 2006.  There was no evidence of a defect from a prenatal test.  This was a normal conception.  On 29 November 2006, at 18 weeks and six days of gestation, the subject gave birth via normal vaginal delivery to a female who weighed seven pounds, three ounces, was 21 and a half inches in length, and had a head circumference of 12 and a half inches.  No birth defects were noted.  Follow up information was received on 05 March 2007 via a reporting nurse, who noted that the subject was 27 years old and was vaccinated during the third trimester of pregancy at an employer's health clinic.  The subject's last menstrual period prior to vaccination was 02 March 2006.  On 06 November 2006, the subject received 0.5 cc of FLULAVAL (intramuscular) in the left deltoid.  The subject had a tattoo just below the injection site.  Two days after vaccination with FLULAVAL, on 08 November 2006, the subject developed an area of redness at the injection site that was approximately one and three-quarters inches wide by three-quarters inches.  The patient did not complain of itching or burning, and the injection site was checked by the nurse daily until the redness resolved completely on 15 November 2006.  In the nurse's opinion, the injection site redness was related to vaccination with FLULAVAL.				Y					Y	11/06/2006	11/08/2006	2	UNK	OTH	PVT	Prenatal vitamins; Potassium iodide +; Calcium salt +; Phosphorus salt +; Vitamin A +; Ascorbic acid +; Niacinamide +; Thiamine hydrochloride +; Riboflavine +; Vitamin D +; Manganese salt +; Iron salt +; Cobalt sulphate +; Magnesium oxide +	UNK	TATTOO The subject had not previously experienced any adverse events following prior vaccinations.  She had no relevant medical history or concurrent illnesses to which the event could have been attributed, and did not use alcohol or tobacco.		A0626789A	1						1	Drug exposure during pregnancy; Injection site erythema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601711~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0271592	02/01/2007	ND	49.0	49		F	01/16/2007	This case was reported by a healthcare professional and described the occurrence of dry tickly cough in a 49-year-old female subject who was vaccinated with FluLaval vaccine for prophylaxis. There was no concurrent medications. The subject had not previously received any flu shots. On 7 November 2006 the subject received 1st dose of FluLaval (unknown, left arm). On 7 November 2006, about three hours after vaccination with FluLaval, the subject developed a dry, tickly cough which had resolved by the next morning. About five hours after her vaccination, her eyes became red. When she woke up the next morning her eyes were pastey and pussy, a discharge was coming out of her eyes. She was prescribed Tobradex by a optometrist. At the time of reporting the outcome of the red and pastey and pussy eyes was unspecified. Follow-up was received from the reporting healthcare professional on 04 December 2006. All the events resolved on 08 November 2006. The healthcare professional considered the events to possibly be related to vaccination with FluLaval.									Y	11/07/2006	11/07/2006	0	UNK	PUB	PVT	No concurrent medication	UNK	The subject had no history of allergies and no chronic health problems.		A0627156A	1						1	Cough; Eye discharge; Ocular hyperaemia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~U2196AA~1~~LL~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0271593	02/01/2007	ND				F	01/16/2007	This case was reported by a healthcare professional and described the occurrence of dry cough in a female subject of unspecified age who was vaccinated with FluLaval vaccine for prophylaxis. On 7 November 2006 the subject received an unspecified dose of FluLaval (unknown). On 7 November 2006, at an unspecified time after vaccination with FluLaval, the subject experienced dry cough and red, pastey eyes. At the time of follow-up reporting, 04 December 2006, the outcome of the events was unspecified. Follow-up was received from the reporting healthcare professional on 04 December 2006. The healthcare professional considered the events to possibly be related to vaccination with FluLaval.									U	11/07/2006	11/07/2006	0	UNK	OTH	OTH		UNK	Per the reporter they had another patient who experienced dry, tickly cough and red, pastey and pussy eyes. Please see A0627156A.		A0627565A	1						1	Cough; Eye discharge; Ocular hyperaemia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~U2196AA~UNK~~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0271594	02/01/2007	IA	48.0			F	01/16/2007	This case was reported by a physician and described the occurrence in hives in a 48-year-old female subject who received Wellbutrin and vaccination with FluLaval vaccine for prophlaxis. Concurrent medications included unknown concurrent medications. Medical history was not provided. On an unspecified date in 2006 before 03 November 2006, the subject initiated therapy with Wellbutrin for an unspecified drug indication. On 03 November 2006 the subject received a dose of FluLaval. On 03 November 2006, the  subject had been receiving Wellbutrin for weeks. About 4 hours following immunization with FluLaval and weeks after initiation of Wellbutrin, on 03 November 2006, the subject developed a rash/hives and went to the emergency room. The subject also experienced a urinary tract infection that developed on an unspecified date on or after 03 November 2006 and before 21 November 2006. The physician considered that the events were probably related to vaccination with FluLaval or therapy with Wellbutrin. At the time of initial reporting, 21 November 2006, the events were improved.				Y					N	11/03/2006			UNK	PVT	OTH	UNK	UNK			A0628526A	1						1	Urinary tract infection; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AF600911~UNK~~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0271595	02/01/2007	PA	61.0	61		M	01/16/2007	This case was reported by a healthcare professional and described the occurrence of maculopapular rash in a 61 year old male subject who was vaccinated with FluLaval for prophylaxis. The subject's medical history included lung issues. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. Concurrent medications included Effexor, Albuterol, Imitrex, Roxicodone, Ultram, Flonase, Claritin, Adodart and Nexium. On 16 November 2006 the subject received a dose of FluLaval in the left arm. The healthcare professional reported that on 16 November 2006, the subject also initiated therapy with a new lung medication. The name of the lung medication was not reported. On 17 November 2006, 1 day after vaccination with FluLaval, the subject experienced maculopapular rash and urticaria. The rash was described as diffuse in location. The subject was seen at a physician's office and was treated with Benadryl and Prednisone. At the time of initial reporting, 21 November 2006, the events were ongoing. The healthcare professional considered the events were possibly related to vaccination with FluLaval. Follow up received on 19 December 2006 indicated that the subject started on Asmanex on 10 November 2006 and she considered that the events could have been associated with this medication. The events resolved on 22 November 2006.				Y					Y	11/16/2006	11/16/2006	0	UNK	PVT	PVT	Effexor, Albuterol, Imitrex, Roxicodone, Ultram, Flonase, Claritin, Adodart, Nexium	UNK	The subject's concurrent conditions were not reported.		A0628849A	1						1	Rash maculo-papular; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601411~UNK~IM~~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0271596	02/01/2007	WA	40.0	40		M	01/16/2007	This case was reported by a healthcare professional and described the occurrence of injection site rash in a 40 year old male subject who was vaccinated with FluLaval for prophylaxis. On 17 November 2006 the subject received a dose of FluLaval in an unspecified arm. On 17 November 2006, the subject also received Havrix at an unspecified site of injection. The next day, on 18 November 2006, the healthcare professional noted that at the site of the FluLaval injection the subject experienced a breakout of rash on the arm of the injection site with a black dot in the middle of the injection site.  The events were completely resolved by 20 November 2006. In the reporter's opinion, the events were possibly related to treatment with FluLaval.									Y	11/17/2006	11/18/2006	1	UNK	PVT	PVT		UNK	The healthcare professional reported that 4 other subjects experienced injection site reactions following receipt of Flulaval from lot 2F600311. Please see cases A0628870A, A0628871A, A0628872A and A0629026A.		A0628866A	1						1	Injection site rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F00311~UNK~~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~UN~HEP A (HAVRIX)~1	USA		Influenza
0271597	02/01/2007	WA	21.0	21		F	01/16/2007	This case was reported by a healthcare professional and described the occurrence of injection site rash in a 21 year old female subject who was vaccinated with FluLaval for prophylaxis. Medical history included non-smoker and non-drinker. On 13 November 2006 the subject received a dose of FluLaval in an unspecified arm. The healthcare professional noted that at the site of the FluLaval injection, on 13 November 2006, less than one day after vaccination with FluLaval, the subject experienced a breakout of rash on the arm of the injection site with a black dot in the middle of the injection site. The events resolved on 14 November 2006. The healthcare professional considered the events to possibly be related to vaccination with FluLaval.									Y	11/13/2006	11/13/2006	0	UNK	PVT	PVT		UNK	The healthcare professional reported that 4 other subjects experienced injection site reactions following receipt of FluLaval from Lot 2F600311. Please see cases A0628866A, A0628870A, A0628872A, and A062026A.		A0628871A	1						1	Injection site rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F00311~UNK~~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0271598	02/01/2007	WA	40.0			M	01/16/2007	This case was reported by a healthcare professional and described the occurrence of injection site rash in a 40 year old male subject who was vaccinated FluLaval for prophylaxis. Medical history included non smoker and non drinker. On 17 November 2006 the subject received a dose FluLaval in an unspecified arm. On 17 November 2006, the subject also received Havrix at an unspecified site of injection. The healthcare professional noted that at the site of the FluLaval injection, on 17 November 2006, less than one day after vaccination with FluLaval, the subject experienced  a breakout of rash on the arm of the injection site with a black dot in the middle of the injection site. The events resolved on 20 November 2006. The healthcare professional considered the events to possibly be related to vaccination with FluLaval.														PVT	PVT		UNK	The healthcare professional reported that 4 other subjects experienced injection site reactions following receipt of FluLaval from lot 2F600311. Please see cases A0628866A,  A0628870A, A0628871A, and A0629026A.		A0628872A	1						1	Injection site rash; Skin discolouration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F600311~UNK~~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~UN~HEP A (HAVRIX)~1	USA		Influenza
0271599	02/01/2007	NC	27.0	27		F	01/16/2007	Erythema, injection site warmth, injection site mass, pruritus									N	11/27/2006	11/28/2006	1	UNK	OTH	PVT		UNK	The subject had never had a flu shot in the past.		A0630134A	1						1	Erythema; Injection site mass; Injection site warmth; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0271600	02/01/2007	AZ	46.0			F	01/16/2007	This case was reported by a healthcare professional and described the occurrence of injection site redness in a 46 year old female subject who was vaccinated with Flulaval for prophylaxis. On 27 December 2006 at 12:00 the subject received 1st dose of Flulaval (.5ml, subcutaneous) instead of a tuberculin skin test. She experienced injection site redness, wrong drug administered and wrong route of administration. The subjec had already received an influenza vaccination this year. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Flulaval.									N	12/27/2006	12/27/2006	0	UNK	OTH	OTH		UNK			A0632641A	1						1	Incorrect route of drug administration; Injection site erythema; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F02611~UNK~SC~~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0271613	02/01/2007	CA	6.0	6		F	02/01/2007	10 x 6 cm area of erythema on left deltoid area developed, one day after patient received an Influenza A vaccine. Erythema is around and distal to injection site. No fever. No tenderness. No treatment required - observation. Of note last year patient also had similar reaction to the influenza vaccine but was thought to be cellulitis and was treated with antibiotics. (Mom states it was reported).									Y	01/10/2007	01/11/2007	1		PVT	UNK				similar area of erythema~Influenza (Seasonal) (Fluzone)~NULL~4.90~In Patient		1						1	Injection site erythema; Similar reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~U2166KA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0271616	02/01/2007	KY	74.0	74		M	02/01/2007	PATIENT HAD A PNEUMOVAX INJECTION IN RIGHT ARM.  PATIENT CALLED THE MORNING AFTER INJECTION AND STATED: THERE IS A LARGE PONE IN THE AREA OF THE INJECTION.  ARM IS SWOLLEN AND WARM TOO TOUCH. SWELLING AS NOT REACHED THE ELBOW.  ARM IS NOT RED.  HAD FEVER AND CHILLS AND WAS UNABLE TO SLEEP THE NIGHT AFTER INJECTION DUE TO THE PAIN. PATIENT WAS CALLED BACK BY THE NURSE LATER THAT DAY AND STATED THAT HIS ARM WAS BETTER, NO FURTHER SWELLING, NO HEAT NOTED.									Y	01/09/2007	01/09/2007	0		UNK	UNK	Medications                              Status ========================================================================= 1)   ALPRAZOLAM 0.25MG TAB 0.25MG MOUTH EVERY 12     ACTIVE        HOURS AS NEEDED 2)   ASPIRIN 81MG EC TAB 81MG MOUTH	No	PMH: 1. CARCINOMA, PROSTATE  2. Diverticulosis, colon * (ICD-9-CM 562.10)  3. Cerebral atherosclerosis (ICD-9-CM 437.0)  REPEAT CAROTIDS 4/07  4. OTHER GENERAL SYMPTOMS  5. Knee: arthralgia * (ICD-9-CM 719.46)  6. Cholecystectomy (ICD-9-CM 575.9)  7. PUD * (ICD-9-CM 533.90)  8. Hypertrophy (Benign) of Prostate without Urinary obstruction (ICD-9-CM 600.0  9. Nightmares (ICD-9-CM 307.47) 10. Depression * (ICD-9-CM 300.4/311.) 11. DJD * (ICD-9-CM 715.90) 12. GERD * (ICD-9-CM 530.81) 13. Bilateral Cataracts (ICD-9-CM 366.8) 14. Malignant Neoplasm of the Prostate  Date of Dx: 6/16/98 - cT1cN0M0-Stage II 15. HYPERLIPIDEMIA NEC/NOS 16. GENERALIZED ANXIETY DIS 17. HYPERTENSION NOS 18. PRIM CARDIOMYOPATHY NEC 19. ESOPHAGEAL REFLUX 20. ELEVATED PSA 21. HYPERPLASIA OF PROSTATE			1						1	Chills; Injection site pain; Injection site swelling; Injection site warmth; Insomnia; Pyrexia	FLU3~SANOFI PASTEUR~U2292AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0988F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0271619	02/01/2007	CA	3.0	2	.6	M	01/31/2007	Vomiting one time. Denies fever and rash.									Y	01/29/2007	01/30/2007	1	NONE	PVT	PVT		NONE	NONE			1						1	Vomiting	FLU3~SANOFI PASTEUR~U2191BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~~2~IM~LL~HEP A (VAQTA)~1	USA		Influenza
0271620	02/01/2007	NM	10.0	10		M	01/31/2007	Syncope at time of vaccine administration. Patient was placed in a supine position with head lower than up. He regained consciousness spontaneously without complication.									Y	01/27/2007	01/27/2007	0	NONE	PVT	UNK		NONE	NONE			1						1	Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71037~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARCEL~MERCK & CO. INC.~0915F~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0271624	02/02/2007	CA	4.0	4		F	11/30/2006	Patient received Dtap and IPV left deltoid and MMRV and flu Right deltoid. About 5 minutes after administering patient developed aheal on at front shoulder, deltoid, arm and itchy. No respiratory distress. Chest normal in exam. Patient fussy called about 3 hours later patient seen. Patient seen clinic 11/30/06 and hives resolved and no symptoms.										11/29/2006	11/29/2006	0	NONE	PVT	OTH	Oral med for anemia	History anemia but resolved.	NONE			1						1	Irritability; Pruritus; Urticaria	DTAP~SMITHKLINE BEECHAM~AC14B035AA~UNK~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2249AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y10512~UNK~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~1261F~UNK~SC~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0271630	02/02/2007	CA		54		F	01/29/2007	Right deltoid-almond size red, swollen, hard, painful lump when approved. 10/18/06 AM when woke up -then area became blistered. Then came down with fever blisters, nose, lips, stuffy head, nose, head congestion. Primary care physician told her never to get flu shot again.									Y	10/17/2006	10/18/2006	1	NONE	PVT	PVT	Dilantin, Atenolol, Levothroxin	NONE	Subdural hematoma, high blood pressure, hypothyroid, penicillin, sulfa, codeine, hydrochlorathiazide			1						1	Blister; Drug hypersensitivity; Herpes simplex; Injection site erythema; Injection site induration; Injection site pain; Injection site swelling; Nasal congestion	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA213BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0271632	02/02/2007	MI	58.0	58		M	11/09/2006	Symptoms began at approximately 7pm and lasted 4-5 hours. Complained of chills, achy, headache and upset stomache. Felt okay next morning.									Y	11/08/2006	11/08/2006	0		PUB	PVT		NONE	NONE			1						1	Chills; Headache; Pain; Stomach discomfort	FLU3~SANOFI PASTEUR~U2248AA~4~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0271633	02/02/2007	NM				U		Swelling rash on arms, knees, feet lasted 5 day with no treatment.				Y					Y	12/05/2006	12/06/2006	1		MIL	MIL	NONE	NONE	NONE			1						1	Rash; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0271634	02/02/2007	NM	7.0	7		M	01/26/2007	Hives on face, arms, legs, trunk 2 days after immunizations				Y					Y	01/19/2007	01/21/2007	2	NONE	MIL	MIL	Zyrtec	SAR	Allergic rhinitis			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2259AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB139BA~1~~RA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0271635	02/02/2007	IN	1.0	1	.0	M	02/02/2007	Mother reported child broke out in hives after receiving vaccines.  Stated she gave benadryl and they went away.									Y	02/01/2007	02/01/2007	0		PUB	UNK						1						1	Urticaria	FLU3~SANOFI PASTEUR~112242AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AVAVB106CA~1~~RL~HEP A (HAVRIX)~1|MMRV~MERCK & CO. INC.~1332 F~1~~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08674E~4~~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0271648	02/02/2007	NE	8.0	8		M	02/02/2007	Site of injection on right arm raised, red, and painful.  Redness, edema, and pain have intensified over past 2 days.  Cephalexin prescribed to cover for infection.  Tylenol #3 given prn pain.									U	01/31/2007	02/01/2007	1		PVT	UNK	humalog, lantus	none	diabetes type II			1						1	Infection; Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U2258AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0741R~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0271656	02/02/2007	CA	48.0	48		F	02/02/2007	The day after the immunization, late afternoon, I developed violent chills and could not stop shaking for about 20 minutes.  At that time I developed a fever of 101.5 F.  Fever went away during the night and did not return.  However, the next day I developed a headache which worsened during the evening hours.  This headache lasted through the night (I could not sleep as a result of it); it then faded away during the next day.  FYI:mfr is Sanofi									Y	01/27/2007	01/28/2007	1		PUB	UNK	none	none	various environmental allergies/hay fever	none~ ()~NULL~~In Patient		1						1	Chills; Headache; Pyrexia; Sleep disorder; Tremor	FLUX~UNKNOWN MANUFACTURER~612281AA~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0271660	02/02/2007	WI	7.0	7		F	02/02/2007	By early evening, Jade c/o'd of localized pain in LD, general malaise nnd headache.  She was warm to the touch and 325 mg APAP was given.  She slept on and off w/increasing c/o pain in her LD.  On Oct. 27th, she c/o'd of severe localized pain (as bad as when she broke her arm) and had a temp of 103.2 in the axilla per mercury thermometer.  She continued to c/o headache and vomited X2.  The reddened area had become slighltly raised, red, hot, extremely tender, and spread out from the immunization site to several areas in the LUE above the elbow.  She was seen by her pediatrician around noon, who dx'd cellulitis and possible allergic rx. She was tx'd w/APAP, Benedryl, & Keflex 1.5 t. qid from 10/27-10/29/2007 then switched to cefadroxil 500 mg 1 tab bid x 7d.  Note:  The medication was changed for convenience not ineffectiveness.  By 10/28 temp was down to 101.8 axilla and by 10/30/2006 she was pretty much back to normal.				Y					Y	10/26/2006	10/26/2006	0	none	PVT	UNK	Albuterol & Flovent inhalers	no	asthma; chronic ear infections; prematurity			1						1	Feeling hot; Headache; Hypersensitivity; Injection site cellulitis; Injection site erythema; Injection site pain; Injection site warmth; Malaise; Pyrexia; Sleep disorder; Vomiting	FLUX~UNKNOWN MANUFACTURER~~7+~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PNC~PFIZER\WYETH~0359F~2~IM~LA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0271661	02/02/2007	CA	13.0	13		F	02/02/2007	FAINTING VS SEIZURES. CT AND LABS WNL				Y					Y	01/29/2007	01/29/2007	0		PVT	UNK		NO				1						1	Computerised tomogram normal; Convulsion; Laboratory test normal; Syncope	FLU3~SANOFI PASTEUR~U2176FA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPVX~UNKNOWN MANUFACTURER~0954F~1~IM~RA~HPV (NO BRAND NAME)~1|TDAP~SANOFI PASTEUR~C2638AA~1~IM~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1152F~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0271662	02/02/2007	WA	22.0			M	02/02/2007	achey, feverish, chest  hurting				Y										PVT	PVT	Advair Discus,  Albuterol	asthma, occasional dizziness	asthma			1						1	Chest pain; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72007~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0959F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0271673	02/02/2007	CT	44.0	44		F	01/30/2007	Seriousness criteria other medically significant. Initial information received on 01 December 2006 from a health care professional. A 44 year old female patient, with no pre existing medical conditions and no illness at the time of vaccination, had received a left arm, intramuscular injection of Fluzone SV 2006/2007 lot number U2164AA, on 09 November 2006. Two days post vaccination, the patient experienced weakness in her left arm and hand. She reportedly now has numbness of the left arm and hand. She was examined in the office on 30 November 2006 and referred to neurologist. Diagnostic testing included a Lyme titer and ANA (results not provided). Follow up information received on 10 January 2007 from a health care professional. The patient was taking no other medications at the time of vaccination. Additional medically relevant information was not provided. Follow up information received from 26 January 2007 from a health care professional. The patient was taking no other medications at the time of vaccination. Additional medically relevant information was not provided. Follow up information received on 26 January 2007 from a health care professional. This case had been considered listed non serious for the information received on 01 December 2006 and 10 January 2007. Based upon new information received from this reporter, this case was upgraded to serious. EMG nerve conduction studies performed on 12 December 2006 were normal. A cervical and thoracic MRI performed on 08 January 2007 showed signal abnormality suggesting demyelination. Diagnosis from a neurology consultation was transverse myelitis. The patient is followed by neurology at this time. Additional information was not provided.  1/12/09 Received PCP medical records of 11/28/06-3/17/08. FINAL DX: transverse myelitis Records reveal patient experienced left arm/shoulder, breast & back symptoms of pain, numbness, burning, heaviness, low grade fever, fatigue, impaired touch sensation x 3 wks.  Received flu shot in RA.  Developed hyperesthesia/paresthesia of bilateral extremities, slurred speech & impaired mentation when fatigued.  Referred to neuro x 2.  Tx w/steroids & had some improvement.  2/16/09 Received Neuro consult medical records of 1/12/2007-3/2008. FINAL DX: transverse myelitis Records reveal patient experienced paresthesia of left arm & right leg, painful dyesthesia of left chest wall & feet, spasticity of left leg, fatigue, 18# wt loss.				Y					N	11/09/2006	11/11/2006	2	30/Nov/2006: Lyme titers, ANA tests pending LABS: MRI of c-spine abnormal, MRI  brain normal,  CXR WNL.  EMG/NCS of LUE WNL.	PVT	UNK			The patient had no concurrent illnesses, or past medical history. Other medications the patient may have been taking at the time of the vaccination were not provided.   PMH: chickenpox, overweight.		200603334	1						1	Antinuclear antibody; Bacterial test negative; Demyelination; Hypoaesthesia; Muscular weakness; Myelitis transverse; Blood test; Chest discomfort; Discomfort; Hypoaesthesia; Injection site discolouration; Myelitis transverse; Nuclear magnetic resonance imaging; Pain in extremity; Spinal X-ray	FLU3~SANOFI PASTEUR~U2164AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2164AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0271675	02/02/2007	WA	34.0	34		F	02/02/2007	Swelling, redness, vomiting				Y					N	01/29/2007	01/29/2007	0	NONE	UNK	UNK		NONE	ASTHMA, ALLERGIC RHINITIS			1						1	Erythema; Swelling; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0271679	02/02/2007	TX	5.0	5		M	02/02/2007	tics since vaccine give not down to approx 5/minute										01/29/2007	01/29/2007	0	NONE	PVT	PVT		cold symptoms				1						1	Tic	FLU3~SANOFI PASTEUR~U2167RA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0271663	02/03/2007	CA	61.0	60		M	02/03/2007	pain in arm approx 6 weeks, contacted MD, xray showed infection of bone or covering over bone? at skin injection site. MD: mri shows scar tisswue on bone/periosteo change/osteomyelitis? therapy recommended: physical therapy.									U	11/09/2006	11/09/2006	0	xray /  mri	UNK	PVT	unknown	n/a	unknown			1						1	Bone disorder; Injection site reaction; Nuclear magnetic resonance imaging; Nuclear magnetic resonance imaging abnormal; Osteomyelitis; Pain in extremity; X-ray; X-ray abnormal	FLU3~SANOFI PASTEUR~u2218aa~1~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0268310	02/05/2007	WI	1.83	1	.9	F	11/29/2006	11/23/06 pt had been playing with cousins in the afternoon, had diaper change, started seizing. EMT's came, transported to ER. Temp in ambulance 103.7 rectal.  ER exam, C&R labwork negative.  11/26/06-temp 102 in evening. 11/27/06 recovered. Never acted ill during this time				Y					Y	11/21/2006	11/23/2006	2		PUB	PUB	NONE	NONE	NONE			1						2	Body temperature increased; Convulsion; Laboratory test	FLU3~SANOFI PASTEUR~U2220AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB099CB~1~IM~LL~HEP A (HAVRIX)~2	USA	Emergency room visit	Influenza
0271017	02/05/2007	MO	52.0	52		F	01/28/2007	Extreme pain lower legs, arms, Flu, staph infection onset of diabetes following. EMG given. Shot, antibiotics, pain killers, walking cane.			Y	Y	Y	5		Y	Y	10/03/2006	10/06/2006	3	Guillain Barre Syndrome	PUB	PUB	Advair	NONE	NONE			1						2	Arthralgia; Diabetes mellitus; Dizziness; Electromyogram; Guillain-Barre syndrome; Hypoaesthesia; Lethargy; Musculoskeletal pain; Pain in extremity; Pyrexia; Staphylococcal infection; Vomiting; Diabetes mellitus; Electromyogram; Guillain-Barre syndrome; Influenza; Pain in extremity; Staphylococcal infection; Walking aid user	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70737~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0271683	02/05/2007	IN	1.21	1	.2	M	01/29/2007	Seen on 1/26/07 and received ProQuad, Prevnar, and Flu vaccine. According to grandmother died on Sunday.  4/17/2007 Received Autopsy Report which reveals COD as sepsis with bronchopneumonia & tracheobronchitis.  Anatomic findings include: small abrasions on central forehead; marked congestion & edema of bilat lungs; enlarged heart; small contusion on right forhead; skin lesions around mouth & nares & dried mucous around nares.	Y	01/28/2007							N	01/26/2007	01/28/2007	2	NONE	PUB	OTH	Ibuprofen, previously Pedicare	URI	NONE			1						1		FLU3~SANOFI PASTEUR~U2292AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~1203F~1~SC~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~308682D~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Results in Death	Influenza
0271698	02/05/2007	TN	6.0	6		M	01/26/2007	Large 5cmx5cm area of erythema, edema, discoloration of skin, left upper arm (deltoid).  Follow-up information received - Adverse Event Onset Date/Time 1-4-07 - Seen in office 1-29-07.									U	01/04/2007	01/04/2007	0	NONE	PVT	PVT		NONE	NONE			1						1	Injection site discolouration; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U2262AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0271699	02/05/2007	TX	10.0	10		F	01/09/2007	Large knot 1/2 diameter. Patient placed heat on knot.									Y	01/04/2007	01/06/2007	2		PUB	PUB					TX07001	1						1	Induration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71032~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~MERCK & CO. INC.~1009F~1~IM~LA~HEP A (VAQTA)~1	USA		Influenza
0271700	02/05/2007	TX	12.0	12		F	01/09/2007	Large knot 1 inch diameter. Parent placed heat on knot.										01/04/2007	01/06/2007	2		PUB	OTH	NONE				TX07002	1						1	Induration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71032~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~MERCK & CO. INC.~1009F~1~IM~LA~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~1050F~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0271704	02/05/2007	TX	15.0	14		F	12/20/2006	Hyperventilation within 1 hour of vaccine dose. Very weak for the next three days. Loss of appetite, headache- severe, unable to attend school due to symptoms. 02/07/07-records received and reviewed for DOS 12/11/06 and 2/1/07 Visit of 12/11/06- URI, abscess to left axilla healing. Suspect Asthma.  Visit of 2/1/07-not involved in PE or school sports. uses albuterol as needed. DX:asthma.				Y					Y	12/11/2006	12/11/2006	0		PVT	PVT		Visit of 12/11/06- URI, abscess to left axilla healing.				1						1	Anorexia; Asthenia; Headache; Hyperventilation	FLU3~SANOFI PASTEUR~U2292AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~UL2155CA~1~~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2455AA~1~~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0271706	02/05/2007	NJ	32.0	32		F	10/23/2006	Pain in left shoulder since 10/13/06 (date of vaccine administration). Seems to be getting  increasingly worse.									U	10/13/2006	10/13/2006	0		PUB	PVT	(Canada)-vitamin, Domperidone (gastroperesus)	NONE	gastroperesis, irritable bowel, osteopenia, Meneire's disease			1						1	Musculoskeletal pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA206BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0271715	02/05/2007	CA	46.0	46		M		Right neck Lympadenopathy.									Y	01/08/2007	01/11/2007	3		PVT	PVT		NONE	NONE			1						1	Lymphadenopathy	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71647~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C2689AA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0271716	02/05/2007	WA	1.52	1	.5	M	01/31/2006	Cellulitis/abscess right leg - given Zithromax. Sl of rash/vesicles on abdomen.									U	01/17/2007	01/27/2007	10	NONE	PVT	PUB	Multivitamin	Gastroenteritis	Hemangioma, egg white, milk, wheat, corn, gastroenteritis			1						1	Abscess limb; Blister; Cellulitis; Rash	DTAP~SANOFI PASTEUR~C2490AA~4~IM~~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2201EA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0931F~2~IM~~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~1062F~1~SC~~VARICELLA (VARIVAX)~1	USA		Influenza
0271748	02/05/2007	KS	4.0	4		M	02/05/2007	Around 7pm on 2/3/07 the pt was c/o pain in his left arm to his father. Father just thought he was c/o pain from having his shots the day before. On 2/4/07 at 4:30pm the mother noticed a problem with the pt' arm when bathing him. Mom noticed arm doubled in size, hard to touch with warmth and redness. She noticed a large bruise to left deltoid of 2-3cm. Mom called 24hr nurse hotline and was instructed to take to ER. At 5:30 pt was taken to ER. ER Dr. told mom it was a local rx with some damage to tissue. Dr. instructed mom to observe arm for further problems. Dr. prescribed Keflex for 5days TID. Dr. instructed to apply ice prn and to make appt. with PMD in 2-3 days.				Y					N	02/02/2007	02/03/2007	1	Pt was given a 5 day round of Keflex per ER Dr.	PUB	PUB	None	None	Zithromax			1						1	Contusion; Erythema; Induration; Injection site warmth; Local reaction; Oedema peripheral; Pain in extremity	DTAP~SMITHKLINE BEECHAM~AC14B036BA~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2260AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~1393F~2~SC~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0271763	02/05/2007	KY	0.82	0	.8	M	02/01/2007	12/16/06 21:45 Subject taken to ER for lung congestion and fever. WBC 12.2 other labs WNL, Chest x-ray perihilar congestion due to recent URI or bronchitis. RSV negative, NKDA. Discharge home after ER observation at 7:50 hours.				Y					Y	12/12/2006	12/16/2006	4	WBC 12.2, chest x-ray perihilar congestion	PUB	PUB	Oragel and Tylenol as needed	Viral rash illness previous month	Hearing impairment noted at birth			1						1	Chest X-ray abnormal; Pulmonary congestion; Pyrexia; Virus serology test; White blood cell count normal	FLU3~SANOFI PASTEUR~U2187AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0271797	02/06/2007	NY	79.0	79		F	01/30/2007	Three days after Influenza vaccine, my mom's vocal cords were both paralyzed. She had to be intubated and given a tracheostomy. She never recovered.  2/12/07 Received medical records from hospital which reveal patient experienced SOB & abdominal pain on 11/2/06.  ENT consult revealed fixed vocal cords & required emergency entubation then tracheostomy.  G-tube placed for nutrition. Throughout hospitalization, had intermittent a-fib & nonsustained v-tach.  Patient was noted to be depressed & was evaluated by psych. Pt was transferred to SNF unit for rehab. 2/15/07 Received Death Certificate from daughter which reveals COD as cardiopulmonary arrest; COPD; & CAD.	Y	01/23/2007	Y	Y	Y	50	Y	Y	N	10/31/2006	11/03/2006	3	CT scan - Bilateral vocal cords not due to stroke or tumor.	PVT	OTH	Digoxin, Atenolol, Tylenol, Nexium, Coumadin	Compression fraction - lower lumbar	Rheumatoid arthritis, lung disease, congestive heart failure PMH: MI, atrial fib, defibrillation, HTN, GERD, hiatal hernia, severe rheumatoid arthritis, losteoporosis, umbar compression fx, severe kyphoscoliosis w/restrictive lung disease, constipation, COPD, pulmonary fibrosis, bronchiectasis, SIADH, recurrent aspiration, sleep apnea, chronic anemia, hyponatremia.			1						1	Computerised tomogram; Intubation; Tracheostomy; Vaccination failure; Vocal cord paralysis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Results in Death	Influenza
0271807	02/06/2007	IL	1.01	1	.0	F	02/01/2007	Ventricular tachycardia 02/20/07-records received and reviewed for DOS 01/21-01/29/07; DC DX: ventricular tachycardia. Presented to clinic on 1/18/07 with poor feeding and rapid heart rate. Heart rate in ER 260 and 280 felt to be in stable SVT and received two doses of adenosine without any change. Fluid resuscitated and given amiodaron with resolution of tachycardia. Episodes of bigeminy, trigeminy and PVCs. Transported to another Hospital.  PMH:multiple ophthalmic abnormalities including bilateral microcornea, bilateral sclerocornea with opacification and bilateral micro-ophthalmus. Nonaccidental trauma left arm 11/06. PE:Oxygen sats on RA 98%. WNL			Y	Y	Y	12			Y	01/16/2007	01/18/2007	2	EKG 2Dechocardiogram normal and showed normal systolic function.  Cardiac MRI normal Viral studies for myocarditis normal. EKG: QTc not elongated.	PVT	PVT	NONE	NONE	Corneal opacities, Microcephaly  PMH:multiple ophthalmic abnormalities including bilateral microcornea, bilateral sclerocornea with opacification and bilateral micro-ophthalmus. Nonaccidental traum left arm 11/06.			1						1	Electrocardiogram; Ventricular tachycardia	FLU3~SANOFI PASTEUR~UT2174JA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF012AA~3~IM~LL~HIB (ACTHIB)~1|MMRV~MERCK & CO. INC.~1390F~1~SC~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08675F~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Life Threatening,Hospitalisation	Influenza
0271809	02/06/2007	SC	3.0	3		M	01/31/2007	Right thigh area to medical aspect of where immunization given with obvious redness and swelling. Warm to touch. Lines around redness and within 20 mins, lines had spread & swelling enlarged.  3/15/07 Received medical records from hospital which reveal patient experienced right lower extremity pain, swelling & redness on 1/30/07, day after vax.  Initially seen at outlying ER on 1/30 for eval & d/c to home.  Then on 1/31 had increased swelling, pain & limp & was admitted for IV antibiotics overnight, responded well & was d/c to home on oral antibiotics for 7 more days. FINAL DX: right lower extremity swelling, likely secondary to adverse immunization reaction.				Y	Y	1			U	01/29/2007	01/30/2007	1	LABS: WBC 11.  Blood c/s neg.  X-rays revealed diffuse soft tissue swelling about the right knee.	OTH	OTH	Nasonex	NONE	Pulmonary stenosis PMH: pulmonary artery stenosis			1						1	Injection site erythema; Injection site oedema; Injection site warmth; Arthralgia; Blood culture negative; Cough; Dysstasia; Erythema; Full blood count; Gait disturbance; Injection site erythema; Injection site pain; Injection site swelling; Joint effusion; Nasal mucosal discolouration; Oedema peripheral; Otitis media; Pain in extremity; Rhinitis allergic; Rhinorrhoea; Sinus disorder; Soft tissue disorder; White blood cell count normal; X-ray limb	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B040BA~4~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2249AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0240~3~SC~RL~POLIO VIRUS, INACT. (IPOL)~1|DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B040BA~5~IM~LL~DTAP (INFANRIX)~2|FLU3~SANOFI PASTEUR~U2249A~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|IPV~SANOFI PASTEUR~Z0240~4~SC~RL~POLIO VIRUS, INACT. (IPOL)~2	USA	Hospitalisation	Influenza
0271810	02/06/2007	KY	4.0	4		F	02/06/2007	Influenza vaccine given 2/3/07. At bedtime on 2/4/07 Mom noted mosquito looking bumps at at daughters hairline. Child was given Benadryl and bumps disappeared. Mom repeated Benadryl 2/5/07 do to bumps on arms. Bumps do itch. Mom denies diarrhea or fever. Mom referred to MD. This was daughters 3rd time receiving the influenza vaccine.				Y					U	02/03/2007	02/04/2007	1		PUB	PUB	Denies	NONE	NONE			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U2250AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0271812	02/06/2007	VA	5.0	5		M	02/05/2007	Erythematous itchy area upper arm L, seen by me 2/5/07. Pt already seen by Peds first urgent care and put on Keflex. Recommended Benadryl PO, Topical Cortisone.				Y					Y	02/01/2007	02/01/2007	0		PVT	PVT			NKDA			1						1	Erythema; Pruritus	FLU3~SANOFI PASTEUR~U2260AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1256F~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0271815	02/06/2007	MA	1.04	1	.0	F	02/02/2007	Chicken Pox										11/15/2004	01/30/2007	806		PVT	UNK						1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U1388AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X07712~3~~RL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~A57556D~3~~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0277P~UNK~~~VARICELLA (VARIVAX)~1	USA		Influenza
0271816	02/06/2007	MA	1.02	1	.0	F	02/02/2007	Chicken Pox										11/08/2004	02/02/2007	816		PVT	UNK						1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U1388A~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~X07712~3~~LA~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~A57556D~3~~RA~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0583P~UNK~~~VARICELLA (VARIVAX)~1	USA		Influenza
0271817	02/06/2007	IL	0.9	0	.9	F	02/01/2007	Mother states noted hives both groin and arm pit areas less than 24 hr after injection. Hives giant size and spreading to face and trunk. Irritable no fever, cold symptoms prior to immunization. No reaction noted after 1st influenza shot.				Y					U	01/31/2007	02/01/2007	1	UNK	PUB	PUB		Reported cold symptoms	NONE			1						1	Angioneurotic oedema; Irritability; Urticaria	FLU3~SANOFI PASTEUR~U2220FA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0271822	02/06/2007	MO	65.0	65		F	01/22/2007	Pruritic rash (entire body) X few days was ill 3-4 days after flu shot.				Y					U	11/27/2006	11/28/2006	1		OTH	OTH			NKA			1						1	Malaise; Rash pruritic	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0271823	02/06/2007	KS	53.0	53		F	02/01/2007	Same day of shot nausea, fever, chills, body aches, left humerous red, swollen and tender. Pt was seen 2 days after onset and treated with Septra DS. Pt was diagnosed with Cellulitis.				Y					Y	12/05/2006	12/05/2006	0		PVT	PVT	Tylenol, Lipitor, Niaspan, Effexor, Tamoxifen	NONE	Hyperlipidemia, COPD, Breast cancer, OA			1						1	Cellulitis; Chills; Injection site erythema; Injection site oedema; Injection site pain; Nausea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2292AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1174F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0271826	02/06/2007	CA	1.45	1	.5	M	01/29/2007	Dtap site developed moderately severe abscess subcutaneously, responding to antibiotic.									Y	01/19/2007	01/25/2007	6	None	PVT	PVT	NONE	NONE	NONE			1						1	Abscess	FLU3~SANOFI PASTEUR~UT2175CA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0510F~1~IM~LL~HEP A (VAQTA)~1	USA		Influenza
0271832	02/06/2007	TN	36.0	36		F	02/01/2007	Awoke about 10pm on 1/31/07 couldn't see, hear, speak, had a cold, body hurt all over, vomiting, blacking out. Daughter called 911 transported to ER released about 11:45 pm received IV fluids and some lab work. Dr ruled it an adverse reaction to flu shot.				Y					Y	01/31/2007	01/31/2007	0		PUB	PUB			GERD, Migraines			1						1	Aphasia; Blindness; Deafness; Loss of consciousness; Nasopharyngitis; Pain; Vaccination complication; Vomiting	FLU3~SANOFI PASTEUR~U2292AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0271833	02/06/2007	OR	45.0	45		F	02/06/2007	About 3:00 pm a lot of heat in 6 inch spot of injection site. 5:00 pm looked at it - it was very red and hives were starting. 7:00 pm - a lot of pain. By 9:00 pm couldn't bend elbow. Patient didn't do anything. Then went to bed after 9:00 pm, slept horribly because pain was extreme. Every time turned or moved pain woke her up. 7:00 am next morning took a shower but couldn't raise right arm. it was swollen and hives spread 3 inches below the elbow, 1/2 around upper arm and 6 inches short of shoulder and 1/4 high, lots of heat. She went to church, left church and laid down for 1/2 hour. Then at 2:00 pm went home and laid down. A friend called her doctor. He said to ice it and take Benadryl. She iced it but felt physically better, but didn't look better. Went to bed early around 8:00 pm and slept fitfully, was still painful, but less than the night before. on 2/5 at 7:00 am was told shot was in her right arm. Went to dentist at 9:00 am and they looked at it and told her to take Benadryl and asked if she was okay to stay for appointment. She said yes. After appointment at 11:00 picked up her mom and drove to pharmacy and bought Benadryl. Waited untl 1:00 pm to take it, until she was home because it makes her drowsy. Took a nap until 2:30 and then picked up son from school at 3:00. Drove him to bass lesson at 4:30, home at 7:00 pm, took another dose of Benadryl at 9:00 pm and ibupropen - 3 tablets of 200 mg and went to sleep. Slept much better. At 6:00 am next morning heat is gone, mild pain, but redness from below the elbow until 6 inches above shoulder.									N	02/03/2007	02/03/2007	0		OTH	PUB	Methimazole, Lexapro, multivitamin		Graves disease, had allergic reaction to vitamin C shot, allergic to preservative when given at 20 years old			1						1	Hypokinesia; Injection site erythema; Injection site pain; Injection site urticaria; Injection site warmth; Oedema peripheral; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1036P~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0271876	02/06/2007	SD	1.2	1	.2	F	02/05/2007	Presents to clinic 2/3/07 - bright red rash covering entire body.  Some hair loss.  No VZV type of rash noted.									Y	01/23/2007	01/31/2007	8	2/1/07 - VZV type of rash was seen at a different clinic.	PVT	PUB	NA	Pharyngitis - started on Amoxicillin	Etopic exzematous dermatitis			1						1	Alopecia; Erythema; Rash; Rash vesicular	FLU3~SANOFI PASTEUR~U2174KA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0255F~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08666B~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1057A~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0271539	02/07/2007	PA	89.0	89		F	02/02/2007	Initial report received from a daughter of a patient on 11 January 2007. An 89 year old female patient (with a history of arthritis and hypertension) developed generalized joint pain about a week, after she received Fluzone (lot number U2213AA, route of administration not reported) in the left deltoid on 25 October 2006. She was evaluated by a physician and was treated with PT and Tylenol. The patient did not have any laboratory tests performed. The patient receives the flu shot yearly. She did not have any illness at the time of vaccination. At the time of the report, the patient had not recovered. Follow-up information received on 29 January 2007, from a health care professional. The report was upgraded to serious. The patient was presented in November 2006 for signs and symptoms of bilateral upper thigh pain, clinically found to be osteoarthritis (OA). P.T. was ordered. The patient presented in January 2007 with diffuse muscle pain and stiffness. Labs showed elevated ESR (over 80), elevated CRP (2.4) with -L3, L4 and was diagnosed with PMR (Polymyalgia Rheumatica). No illness at vaccination time. Additional concomitant medications included: Diovan, Lipitor and Tensopril. The patient's recovery status was not reported.				Y						10/25/2006	01/01/2007	68		OTH	OTH	Blood pressure pill, Tylenol, Diovan, Lipitor, Tenopril		Arthritis, Hypertension. No illness at vaccination time.		200700085	1						2	Abasia; Abnormal loss of weight; Arthralgia; Blindness unilateral; Blood test; Body temperature decreased; Hypokinesia; Injection site pain; Joint swelling; Muscle swelling; Myalgia; Oedema peripheral; Pain in extremity; Pyrexia; Red blood cell sedimentation rate increased; Arthralgia; C-reactive protein increased; Musculoskeletal stiffness; Myalgia; Osteoarthritis; Pain in extremity; Polymyalgia rheumatica; Red blood cell sedimentation rate increased	FLU3~SANOFI PASTEUR~U2213AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2213AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0271927	02/07/2007	CT	0.54	0	.5	M	02/07/2007	Patient developed explosive diarrhea and emesis shortly after vaccine given. On 2/6/07 he was admitted for worsening vomiting, and on the morning of 2/7/07 he was found to have intussusception.   3/1/07 Received medical records from hospital which reveal patient experienced dehydration, vomiting & diarrhea, tactile temp at home, cough & nasal congestion. Seen in ER x2 then admitted.  After admission, had large maroon stool & continued to have bile tinged emesis.  After confirmation of IS, patient transferred to higher level of care. 3/15/07 Received medical records from transfer hospital which reveal patient admitted 2/7/07-2/8/07 s/p 48 hour history of abdominal pain, diarrhea & 1 week history of flu like symptoms w/bloody stools developing 24 hours prior to admit.  IS successfully reduced w/air enema & kept overnight for observation.   FINAL DX: Intussusception, reduced by air contrast enema.			Y	Y	Y	2	Y		U	01/29/2007	02/07/2007	9	Stool culture and viral studies to be done. Ultrasound showed ileocolic intussecptus and patient was transferred today. Outcome not known yet.  Initial hospital LABS: WBC 10.3, lymps 52, neutro 50.9, bands 1.  CXR showed perihilar markings c/w reactive inflammatory disease or viral pneumonia. KUB shoed dilated bowel.  Abd US showed RUQ IS, likely ileocolic. Transfer hospital LABS: CBC 13.4, segs 30%, lymphs 61%, monos 7%, baso 1%.  Abdominal US revealed IS in RUQ w/dilated small bowel loops proximally & small amount free fluid.  Air contrast enema reduced w/o complication.	UNK	UNK	none	none	recurrent wheezing, h/o RSV bronchiolitis (Nov 2006), eczema PMH: flu like symptoms for approx 1 week prior to admit.			1						1	Diarrhoea; Intussusception; Ultrasound scan; Vomiting; Culture stool; Diarrhoea; Intussusception; Ultrasound scan abnormal; Vomiting; Barium enema; Diarrhoea; Intussusception; Ultrasound scan; Ultrasound scan abnormal; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~ac21b097ab~3~IM~UN~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~ut2191ka~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~b08691a~3~IM~UN~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0942F~3~PO~MO~ROTAVIRUS (ROTATEQ)~1|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B097AB~2~IM~~DTAP + HEPB + IPV (PEDIARIX)~2|FLU3~SANOFI PASTEUR~UT2191K~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PNC~PFIZER\WYETH~B08691A~2~IM~~PNEUMO (PREVNAR)~2|RV5~MERCK & CO. INC.~0942F~2~PO~MO~ROTAVIRUS (ROTATEQ)~2|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B097AB~2~IM~~DTAP + HEPB + IPV (PEDIARIX)~3|FLU3~SANOFI PASTEUR~UT2191KA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~3|PNC~PFIZER\WYETH~B08691A~2~IM~~PNEUMO (PREVNAR)~3|RV5~MERCK & CO. INC.~0942F~2~PO~MO~ROTAVIRUS (ROTATEQ)~3	USA	Life Threatening,Hospitalisation	Influenza
0271930	02/07/2007		35.0			F	02/02/2007	Patient with history of roux-en Y gastric bypass, 35 year old, experienced symptoms of hypoglycemia necessitating surgical management of hr noninsulionoma pancreatogenous hypoglycemia with a distal panoreatectomy and splenectomy.  Post-operatively patient received influenza vaccine and pneumococcal vaccine in the right deltoid on 1/30/2007.  Patient reacted with a cellulitis like reactions. Cultures are currently pending and patient continued to have febrile spikes.					Y					01/30/2007	01/30/2007	0		UNK	UNK			S/P Roux-en Y Gastric bypass			1						1	Cellulitis; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua201aa~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1004f~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0271931	02/07/2007	AZ	5.0			F	02/06/2007	Has a hematoma on left arm at the injection site which is tender and is being treated.									U					PVT	PVT						1						1	Injection site haematoma; Injection site pain	FLU3~SANOFI PASTEUR~U2193AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0271932	02/07/2007	AZ	14.0	14		F	02/07/2007	Patient had a vasovagal syncopal episode with seizure seconds after receiving the vaccine. Checked blood sugar and BP and EKG and everything looked normal. Observed patient in clinic and no problems after.									Y	02/07/2007	02/07/2007	0	EKG, Blood sugar	OTH	OTH		NONE	NONE			1						1	Blood glucose; Blood glucose normal; Blood pressure normal; Convulsion; Electrocardiogram; Electrocardiogram normal; Syncope vasovagal	FLU3~SANOFI PASTEUR~U22522A~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0960F~1~IM~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~UE552AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0271933	02/07/2007	FL	55.0	55		F		Received a Flu shot at pharmacy on October 15th, 2006. Approximately 2 weeks later, I had noticed a tingling sensation I noticed a tingling sensation in my feet and ankles had persisted for 6 weeks. No residual injury noted. Experienced tingling in both feet which had ascended up to my ankles 2 weeks post vaccinated. Sx had resolved December 22nd of same year.									Y	10/13/2006				UNK	UNK						1						1	Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0271929	02/08/2007		28.0	28		M	02/08/2007	Patient presented with c/o of chest pain which started on 24 December 2006. The symptoms of pleuritic and positional chest pain continued and on 31December2006 was admitted for observations.  He was evaluated by a cardiologist and was diagnosed with pericarditits related to Smallpox vaccine.  He was discharged on 1Jan2007 with a follow-up on 5January2007. 02/13/07-records received and reviewed for DOS 01/18/07 DC: Pericarditis.				Y	Y	1			Y	11/22/2006	12/22/2006	30	EKG, cardiac enzymes, CBC, Chem 13.  CXR echocardiagram	UNK	UNK	Maxide					1						1	Cardiac enzymes; Chest X-ray; Chest pain; Echocardiogram; Electrocardiogram; Full blood count; Laboratory test; Pericarditis; Pleuritic pain	FLU3~SANOFI PASTEUR~U2199AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~SANOFI PASTEUR~Z0425~2~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Hospitalisation	Influenza
0271952	02/08/2007	KY	54.0	54		M	02/08/2007	He started out with severe pain in both arms which progressed to pain with numbnes and tingling. We visited the Emergency room 3 times for the umbearable pain.  On 12/3/2006 he became ataxic along with the pain.  He was admitted to the hospital and 3 days later he was unable to take more than one step.  He was very weak and uncoordinated.  He was sent to hospital where more extensive testing could be done.  He worsened until he could not walk at all and could not even feed himself.  He was diagnosed with Gullian Barre' Syndrome.  2/12/07 Received medical records from transfer facility which reveal patient experienced generalized weakness & was admitted 12/6-12/9/06.  Patient had not been feeling well since Thanksgiving starting with shoulder & extremity pain which persisted & was seen in ER several times.  Received bilateral shoulder injections.  Weakness progressed to point of inability to ambulate & was hospitalized at initial hospital.  Dx & tx at transfer hospital.  Neuro consult done.  Tx w/IVIG.  Had persistent HTN despite meds. D/C to home w/continued home PT & neuro f/u.  No EMG/NCS report included with records.  T/C to hospital to request same. FINAL DX: Guillain Barre syndrome; HTN, poorly controlled; & pneumonia.				Y	Y	6			Y	11/19/2006	11/22/2006	3	He had CT scans,  X-rays, MRIs, Lumbar puncture and Nerve conduction studies. LABS: LP w/glucose 56 & protein of 116.  ALT 49.  Na 131. WBC 16.9.  Sed rate WNL.  MRI of brain, c,t & l spines were essentially WNL showing chronic ischemis gliotic changes & DJD.  US of kidneys & renal artery studies were WNL. 3/13/07 Received EMG/NCS report which reveals demyelinating peripheral neuropathy c/w GBS.	UNK	UNK	Lipitor, Diltiziem, Lisenopril	none.  Had cough 2 weeks earlier.	Hypertension, High cholesterol, PMH: HTN, hyperlipidemia, constipation.			1						1	Abasia; Asthenia; Computerised tomogram; Coordination abnormal; Guillain-Barre syndrome; Hypoaesthesia; Lumbar puncture; Nerve conduction studies; Nuclear magnetic resonance imaging; Pain; Pain in extremity; Paraesthesia; X-ray	FLU3~SANOFI PASTEUR~U2164AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0271974	02/08/2007		27.0			M		A report was received from a company distributor on 30/Jan/2007 concerning a 27-year-old male vaccinee. No details concerning the vaccinees past medical history or concomitant medications were provided. The vaccinee received Fluvirin vaccine on 22/Oct/2003. A few days post vaccination he developed weakness and impaired sensation in the left leg as well as movement and walking difficulties when difficulties when stepping on that leg. The vaccinee was hospitalized for 7 days between 29/Oct/2003 and 04/Nov/2003, where a series of tests and treatments were performed (not specified). The vaccinee was then discharged with follow medical treatment. The vaccinee continues to experiences to experience impaired sensation, muscle atrophy, and limited movement of the left leg. He has difficulty standing continually, lifting heavy weights, performing strenuous physical actions and ascending or descending stairs or inclines. The reporter considers these events therefore, to be serious and disabling. Further information will be sought.					Y	0		Y		10/22/2003	10/24/2003	2		UNK	UNK	Concomitant drugs not reported.				CVOX200700019	1						1	Dysstasia; Gait disturbance; Hypokinesia; Muscle atrophy; Muscular weakness; Sensory disturbance	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0271980	02/08/2007	MN	58.0	58		F	02/07/2007	C/O burning at injection site, fingers tingling and cold and swollen. Approximately 1 hr after the injection c/o lips swollen and numb. The following day c/o lips peeling. Patient saw her physician later in Nov. No concerns or problems noted.									Y	11/01/2006	11/01/2006	0		PUB	PVT	Diabetes meds, vitamins, allergy pills PRN		Allergy to sulfa, diabetes.	Flu symptoms~Influenza (Seasonal) (no brand name)~1~0.00~In Patient		1						1	Hypoaesthesia oral; Injection site irritation; Lip exfoliation; Lip swelling; Oedema peripheral; Paraesthesia; Peripheral coldness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71215~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0271991	02/08/2007	IL	0.52	0	.5	M	02/08/2007	Information has been received from a certified medical assistant concerning a 7-month-old male with no medical history or allergies who on 10-AUG-2006, 12-OCT-2006 and 14-DEC-2006 was vaccinated PO with the first, second and third doses, respectively of Rotateq vaccine (human-bovine) (lot#s 65424B/0577F and 655484/1032F - administration dates not specified). There was no concomitant therapy. The CMA reported that on 26-JAN-2007, the patient presented with a rash and vomiting. The patient was diagnosed with an ileocolic intussusception that could not be reduced by Barium enema. The patient was subsequently hospitalized and surgical correction was pending. No laboratory/diagnostic tests were performed. At the time of this report, the outcome was unknown. The CMA also considered the patient's rash and ileocolic intussusception to be life-threatening and other important medical events. Additional information has been requested.  2/22/07 Received medical records from hospital which reveal patient experienced acute onset abdominal pain & vomiting.  Hospitalized from 1/26-1/30/07 after being transferred from outlying hospital.  BE done x3 at outlying hospital revealed intussusception but was unreducible & so subsequently transferred to higher level of care for management.  Air enema done at second hospital also unsuccessful at reducing.  Taken emergently to OR for exp lap & reduction w/appendectomy.  Uneventful recovery & was d/c to home to be f/u w/peds surgeon & PCP. FINAL DX: Ileocolic Intussusception, surgically reduced.			Y	Y	Y				U	12/14/2006	01/26/2007	43	NONE LABS: all WNL.	OTH	OTH	NONE		NONE PMH: asthma, on steroids.		WAES0701USA05034	1						1	Intussusception; Rash; Vomiting; Unevaluable event; Intussusception; Rash; Surgery; Vomiting	RV5~MERCK & CO. INC.~1032F~3~PO~MO~ROTAVIRUS (ROTATEQ)~1|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B070AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~2|FLU3~SANOFI PASTEUR~U2243AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~MERCK & CO. INC.~02181F~2~IM~LL~HIB (PEDVAXHIB)~2|PNC~PFIZER\WYETH~B08675C~3~IM~RL~PNEUMO (PREVNAR)~2|RV5~MERCK & CO. INC.~~3~PO~MO~ROTAVIRUS (ROTATEQ)~2|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B070AA~UNK~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~3|FLU3~SANOFI PASTEUR~U2243AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~3|HIBV~MERCK & CO. INC.~0281F~UNK~IM~LL~HIB (PEDVAXHIB)~3|PNC~PFIZER\WYETH~B08675C~UNK~IM~RL~PNEUMO (PREVNAR)~3|RV5~MERCK & CO. INC.~~UNK~PO~MO~ROTAVIRUS (ROTATEQ)~3	USA	Life Threatening,Hospitalisation	Influenza
0267913	02/09/2007	KY	91.0	91		F	11/28/2006	No symptoms, died within 30 days of recieving vaccine.	Y	11/27/2006							N	11/13/2006	11/27/2006	14	none	PUB	PUB	unknown	unknown	unknown		KY2006045	1						2	Unevaluable event	FLU3~SANOFI PASTEUR~U2258AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0271977	02/09/2007	OR	50.0	50		M	02/08/2007	3 months after getting shot, patients injection site is still scabbing up. It will scab, and the scab will fall off and scab again. Patient reports no fever, no redness, no swelling just the tiny scab, recurring again and again.									Y	11/13/2006	11/14/2006	1		OTH	PVT	NONE	NONE	Iodine allergy, codeine allergy.			1						1	Injection site scab	FLU3~SANOFI PASTEUR~U2218AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0271995	02/09/2007	MO	3.0	3		M	01/30/2007	Progressive flu-like SX. DX with ADEM at Hospital. Significant swelling in brain optic nerve inflamed. Tremors up and down body, Vertigo. (Onset SX end of Dec Cold like SX sinus infection and HA's. MRI, Spinal Tap. Steroids in Hosp x 5 days, still taking Med, will continue x 4 more wk. (Prednisone tapes 30mg to 0).  3/20/07 Received medical records from hospital which reveal patient experienced ataxia & tremor beginning 12/10 w/HA.  Saw PCP & dx w/sinusitis & started antibiotics.  Developed vomiting, dizziness & continued HA & was taken to outlying hospital on 12/24.  CT revealed sinus infection.  On 1/5/07 continued to be dizzy, had tremor & was leaning to right on ambulation.  Readmitted to outlying hospital.  Repeat CT scan showed sinusitis resolved.  D/C to f/u w/PCP.   Saw PCP on 1/8 & had stiff legged walk & was instructed to take to higher level of care hospital if no improvement.  Admitted 1/9/07-1/15/07.  Consults by neuro, optham & ID.  Treated w/high dose steroids.  Improved & d/c to home on tapering steroids to be f/u in neuro & opth clinics. FINAL DX: ADEM & optic neuritis of left eye.					Y	6			Y	11/13/2006	11/18/2006	5	1/10/07 tested (+) influenza A at hospital. LABS: MRI of brain revealed ADEM & optic neuritis of left eye.  Titers showed recent mycoplasm infection.  CSF c/s neg.  Flu A & B neg, Mycoplasma IGM greater than 1:10.	PVT	PVT		NONE	NONE PMH: cold s/s in early December.  Sinusitis.			1						1	Brain oedema; Headache; Inflammation; Influenza like illness; Leukoencephalomyelitis; Lumbar puncture; Nasopharyngitis; Nuclear magnetic resonance imaging; Optic nerve disorder; Sinusitis; Tremor; Vertigo	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72005~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0271996	02/09/2007	MT	3.5	3		F	01/31/2007	Rash started one day after receiving flu vaccine. Benadryl was used x 1 day. Rash resolved after 2 days.									Y	01/19/2007	01/20/2007	1		PVT	PUB	NONE	NONE	previous reaction to vaccine	Rash~Influenza (Seasonal) (no brand name)~1~1.67~In Patient|~Pneumo (Prevnar)~3~0.00~In Sibling|~DTaP (no brand name)~3~0.00~In 		1						1	Rash	FLU3~SANOFI PASTEUR~71032~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0271998	02/09/2007	WA	4.0	4		M	01/26/2007	Left arm swollen and red, hot to touch, fever of 101. 1/24/07 13x16 cm area of redness, slightly swollen but 1355 not tense. Left upper arm									Y	01/24/2007	01/25/2007	1		UNK	PUB			Allergy to shrimp			1						1	Erythema; Oedema peripheral; Pyrexia; Skin warm	DTAP~SANOFI PASTEUR~C2490AA~5~IM~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~R2281AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1031-2~4~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0092F~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0272001	02/09/2007	VA	23.0	24		F	02/03/2007	1515-pt presented with complaints of being shaky after having blood drawn in the lab. I administered the flu vaccine im and pt reported he was fine but then experienced syncope so we had him recline with knees up until he had recovered.										02/03/2007	02/03/2007	0	NONE	MIL	MIL		NONE	pt complained of past vaso-vagal response			1						1	Syncope; Tremor	FLU3~SANOFI PASTEUR~U2308AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0272004	02/09/2007	IL	1.0	1	.0	M	12/31/2006	Pt was getting the flu shot and the nurse giving him the injection gave him an adult dose instead of a pediatric dose. The days following the injection he ran high fevers, was irritable and showed swelling in his thigh where the injection was given, also was red and raised				Y					Y	12/19/2006				PUB	OTH	NONE	NONE	NONE			1						1	Erythema; Incorrect dose administered; Injection site swelling; Irritability; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~3~~~HIB (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~1~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~~4~~~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~~1~~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0272005	02/09/2007	OH	4.0	4		F	01/29/2007	Local reaction, 2x2 cm of erythematous, tender, warm rash on R arm. Symptomatic treatment.									U	01/26/2007	01/28/2007	2	NONE	PVT	UNK		Cold	Asthma, Allergic rhinitis			1						1	Injection site erythema; Injection site pain; Injection site rash; Injection site warmth	DTAP~SANOFI PASTEUR~U1813CA~6~~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2244AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1068~5~~RA~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~1392F~3~~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0272006	02/09/2007	CA				F	01/30/2007	8 yo female with history of seizure disorder; seizure free on trileptal for 2 years, had seizure 2 days after receiving Hep A and Influenza									Y				note pt had one missed dose of seizure meds 24 hours prior to seizure	PVT	UNK			Seizure disorder on meds			1						1	Convulsion	FLU3~SANOFI PASTEUR~UZ310AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB143BA~2~IM~RA~HEP A (HAVRIX)~1	USA		Influenza
0272007	02/09/2007		85.0	85		M	01/26/2007	Lethargy										10/18/2006	10/19/2006	1		UNK	UNK	Glipizide, Iron polysaccharide		CVA, Diabetes Mellitus			1						1	Lethargy	FLU3~SANOFI PASTEUR~U2275AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0272033	02/09/2007	NY	66.0	66		M	02/09/2007	One Day after receiving Flu shot, my father experienced extreme pain throughout his entire body along with fatigue. Soon after, fevers began with night sweats and chills.  He returned to Dr. who prescribed several antibiotics over the course of weeks with no relief.  Symptoms continued and he was hospitalized at a hospital on 12/20/06 - 12/22/06.  Fevers continued to come and go, mostly at night with sweats and chills.  He continued to loose weight and was anemic.  He changed doctors and began seeing another Dr. who noted there was infection but could not determine the cause.  My father was hospitalized again on 01/17/07 - 01/23/07 and was seen by several doctors and administered several tests but doctors have yet to determine the cause of the infection.  On 02/08/07, he visited with a Dr.  who requested I contact CDC b/c he believes the symptoms are related to his Flu Shot of 11/14/06. His blood work continues to be very abnormal and the muscle fatigue/pain, anemia, and fevers continue. My father has been unable to work since this began and had to unwillingly retire due to above events. He has trouble climbing steps and walking even a small distance.  Prior to this he was very active and completely different.  My father had had prior Flu shots in the past but hadn't had the vaccine in about 4 years. He never experienced any reaction like this.  03/05/2007 MR received from PCP. Multiple OVs from 12/08/2006 to 01/03/2007 for c/o fever. Temp 101.8 on 12/15/06 and 101.1 on 12/29/06.  Fatigue and malaise noted on 12/29/06. DX: FUO.  04/27/2007 MR received for 2 hospital admits 12/20-22/2006 and 1/17-23/2007. Initial admit for c/o cough, generalized aches and weakness. PE: WNL. Prinicipal Dx:  1) Acute Bronchitis. 2)  Malaise/Fatigue.  2nd Admission for c/o fever on and off x 2 months. C/O chills, generalized aches and fatigue. PE: WNL. Principal DX: 1)  Fever of Unknown Origin. 2) Anemia with Thromobocytosis, mild colitis.			Y	Y	Y	9	Y		N	11/14/2006	11/15/2006	1	Numerous blood work has been conducted along with x-rays, colonoscopy, CT scans, glavscan, and a bone marrow biopsy. Labs and Diagnostics:  CMP 12/18/06 WNL, CBC with WBC of 14.5 (elevated neutrophils and monocytes) and low H&H and RBCs. UA WNL. CXR: no acute pneumonic consolidation, mass or pleural effusion. CBC 12/30/06 with WBCs of 14.3 with elevated neutrophils and monocytes.  ESR high at 45. Labs and Diagnostics: CBC with WBCs 14.7.  Hct 36.9. Hgb 12.1. Sed rate 95, CRP 19.6.  Glucose 115.  CXR with Clinical DX of Pneumonia. Labs and Diagnostics:  01/17/2007 WBC 16.1.  HCT and HGB low. Platelets 618.CRP 21.2. RF (+). RF Titre 80. UC (-), Blood cx (-). CT of Chest, Abd. and Pelvis ? mild colitis.  Neck CT Normal. Echocardiogram. Colonoscopy showed Diverticulosis, Cecal polyp, and internal hemorrhoids.  Bone Marrow Bx done-no results.	UNK	UNK	NONE	NONE	Anemia - given a B-12 shot same day of Flu shot by Dr.  PMH: none.  Allergies: NKDA			1						1	Anaemia; Biopsy bone marrow; Blood test; Blood test abnormal; Chills; Colonoscopy; Computerised tomogram; Fatigue; Gait disturbance; Infection; Muscle fatigue; Night sweats; Pain; Pyrexia; Weight decreased; X-ray	FLU3~SANOFI PASTEUR~U2184AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0272063	02/09/2007	MI	4.0	4		M		2.19.06 Patient received vaccines. 2.20.06 Patient seen at hospital ER for acute medicine shot reaction right thigh swollen, red, hot, tender to touch. Treated with Prelone 15 mg 15ml 1 tab PO every day for 5 days plus Benadryl 12.5 mg/5ml 1/2 tsp PO every six hours.				Y					Y	12/19/2006	12/20/2006	1		OTH	UNK	Tylenol at 09:00	NONE				1						1	Injection site erythema; Injection site pain; Injection site warmth; Swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B033AA~5~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2307AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1030~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0497F~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0272051	02/12/2007	KY	1.5	1	.5	M	02/12/2007	Patient received DTaP #4 and Prevnar #4 on January 2, 2007 and DTap #5 and Prevnar #5 on February 7, 2007.  After vaccines, patient had fever over night of 101, pain at injection site, very mild edema. no erythema or echymosis									Y	02/07/2007	02/07/2007	0		PVT	PVT	none	none	none			1						1	Injection site pain; Oedema; Pyrexia	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B040AA~5~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U22OEA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB143BA~2~IM~LL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~B08672E~5~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0272083	02/12/2007		13.0	13		M	02/09/2007	Information has been received from a medical assistant concerning a 13 year old male with environmental allergy who on 24-JAN-2007 was vaccinated with the first dose of Pneumovax 23 vaccine (lot#651399-0486F, expiration 08-MAY-2007), 0.5 ml, IM left arm. Concomitant mediation included influenza virus vaccine (unspecified) (patient requested flu vaccine to be administered in the same arm). and fexofenadine hydrochloride (ALLEGRA). On 25-JAN-2007, the patient called the physician's office and said that his arm was hurting. On 26-JAN-2007, the patient presented to the physician's office. On 26-JAN-2007, the patient went to the hospital with cellulitis of left arm and possible allergic reaction. The patient was treated with vancomycin and another medication. The physician stated that he considered the antibiotics an intervention to prevent serious criteria. The patient's cellulitis of left arm and possible allergic reaction persisted. Cellulitis of left arm and possible allergic reaction were considered to be disabling and other important medical event. Additional information has been requested.					Y		Y	Y	N	01/24/2007	01/25/2007	1		OTH	OTH	Allegra		Environmental allergy		WAES0701USA04890	1						1	Cellulitis; Hypersensitivity; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0486F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation,Disabling	Influenza
0272090	02/12/2007	MI	49.0	49		M	02/07/2007	Received a flu shot in my left arm which hurt very much when given. The hurt is still there today. Been to several doctors and therapy, but still have the pain, which all these problems were not there before. I have the lot number and nurse number. The vaccine was out of clinic. I am having alot of problems and was told it was given wrong or something was wrong with the vaccine.  3 others at work are having problems also. I was told by my pharmacist to get in touch with you.  02/27/2007 MR received from consulting neurologist.  3 visits from 01/05/2007 to 02/19/2007 for c/o pain and weakness in the left arm since receiving flu shot 11/17/2007.  PE (+) for left arm pain and difficulty raising left arm against gravity >90'. Impression: Left ulnar neuropathy.  Left arm pain.  AE from Flu shot.  03/05/2007 MR received from PCP for several office visits for c/o left shoulder pain following flu shot.  1st visit 12/04/2006 with pain level 6/10.  F/u 12/21 and 02/01/2007.  Impression:  Left Shoulder Impingement. Ortho consult 01/12/2007 showed discomfort upon forward flexion and slightly decreased external rotation on the left. Ortho did not feel the bone spur evident on the MRI had any bearing on his clinical symptoms.  No DX made although improvement was reported on NSAID and muscle relaxer. Per annual follow up information, recipient has not recovered. Left arm still hurts-deltoid muscle is still affected. Went to doctors, neuro-surgeons, and therapy 8 wks & then additional 8 wks. No one would take the repsonsiblity. I am afraid to get the flu shot again and still paying some of the doctors for the pneumonia one.								Y	N	11/17/2006	11/17/2006	0	12-04-06-misc testing, 12-13-06 prostate specific antigen and well adult misc, 12-15-06 MRi, 12-26-06 misc testing, 1-08-07 laboratory. Labs and Diagnostics:  EMG did not show any radicular, myopathic, or degenerative changes.  CPK high at 176, C-reactive protein low at <0.3, ESR normal, Aldolase normal, ANA normal. MRI of shoulder showed AC spur causing mild impingement upon the underlying supraspinatus muscle.  Shoulder X-ray showed no acute fracture or dislocation.  Cardiac stress test normal.	UNK	UNK	Meds:  ASA.		NONE. PMH:  High cholesterol. Allergies:  NKDA.			1						1	Injection site pain; Nuclear magnetic resonance imaging; Prostatic specific antigen; Vaccination complication	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0272091	02/12/2007	CO	49.0	48		M	02/02/2007	Soreness L upper extremity cellulitis some redness, swelling subjective fever and chills.  03/02/2007 MR received from treating facility for an ER admission for c/o fever, redness and swelling in his Left arm following Flu and Pneumococcal vax.  Initially seen in the ER and sent home on PO antibiotics, he returned the following day with increased redness and swelling and was admitted for IV antibiotics. PE:  WNL except for swelling and redness in the left triceps area, extending distally to the mid forearm. Discharge DX:  Left upper extremity cellulitis.  Hypertension , controlled, Stable CAD, Diabetes mellitus type 2, Hyperbilirubinemia, question Gilbert's syndrome.				Y	Y	1			Y	01/25/2007	01/25/2007	0	Labs and Diagnostics:  CBC WNL, Chemistry WNL except Glucose of 161 and slightly elevated bilirubin.	PVT	PVT	Lipitor, Metformin, ASA, Toprol XL, Glipside, Altace. Meds: Altace, Glypizide, Lipitor, Metformin, Toprol.	NONE	CHD, DM II, CAD (NK allergies). PMH:  Coronary Artery Disease s/p MI in 2003 with stent placement. Type II Diabetes. Hypertension.  Allergies:  none.   Addendum: Reporter varified patient did not have Congenital Heart Disease, CHD=Coronary Heart Disease.			1						1	Cellulitis; Chills; Erythema; Pain in extremity; Pyrexia; Swelling; Blood glucose abnormal; Blood pressure; Cellulitis; Chills; Discomfort; Erythema; Hypokinesia; Mobility decreased; Oedema peripheral; Pain; Pruritus; Pyrexia; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72223~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0889F~1~~LA~PNEUMO (PNEUMOVAX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72223~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~0889F~1~UN~LA~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0272093	02/12/2007	NC	79.0	79		M		10-20-06 vaccine 11:30, at 5pm malaise and tiredness, 10-21-06 loss function legs-walking abscent admit to medical center 11 days CSF done on 10-28-07 100% lymphs viral encephalitis and treat with Acyclovir, 11-1-06 hosp, 11-9-06 nursing home rehab.				Y	Y		Y	Y	N	10/20/2006	10/21/2006	1	toxic encephalopathy, incontinence increased, viral encephalitis, dementia, unable to walk now	PUB	OTH	Avodart 5mg, Razadyne 24mg, Namenda 5mg x2	NONE	Sulfa drugs, dementia, BPH			1						1	Abasia; CSF test abnormal; Dementia; Encephalitis viral; Encephalopathy; Fatigue; Incontinence; Malaise	FLUX~UNKNOWN MANUFACTURER~SPU2178AA~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0272094	02/12/2007	CA	2.0	2	.0	M	02/04/2007	Within 8 hrs of IZ developed a couple of patches of papular erythematous rash. Next am rash was from head to toe. Treated with Benadryl 12.5/5 1-1 1/2 tsp Q 6 PRN rash. Aveeno over the counter.				Y					Y	02/01/2006	02/02/2007	366		PVT	PVT	NONE	NONE	Otitis Media and neonatal jaundice.			1						1	Erythema; Rash papular	FLU3~SANOFI PASTEUR~U2272AA~4~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0272096	02/12/2007	FL	1.25	1	.3	F	02/05/2007	MMR administered on 11/15/06 at 15 month PE. Documented febrile seizure on 11/21/06.				Y					Y	11/15/2006	11/21/2006	6		PVT	PVT	NONE	NONE	NONE			1						1	Febrile convulsion	DTAP~SANOFI PASTEUR~U1985BA~4~~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2243AA~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0276F~1~~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~1027F~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0272097	02/12/2007	MI	59.0	59		F	01/29/2007	Client states severe headache began approx 1030 am 1/23/07. Client describes pain in pariental region of head. Client took homeopathic remedies to try to resolve pain. Histaminicum hydrochloricum, arorica Montana and turmeric capsule. Client denies any other S/SX like nausea. Client applied warm compress to back of head and cold compress to top of head and rested in a darkened room. No prior history of headaches. Client felt HA resolve shortly after 430pm and completely resolve after 1045pm. Client also stated BP taken at home by self has elevated at 13/72 at 1/2pm from am reading approx of 102/58.									Y	01/23/2007	01/23/2007	0		PUB	PUB	Multivitamin, Glucosamine sulfate with MSM, Citrucal with Vit D, ASA, Spiriva, Asmanex, grape seed extract, Tumeric.	Asthmatic bronchitis for 6 wks prior to vaccine date 1/23/07	Asthma, myofacial dysfunction, cervical neuralgia, trigeminal neuralgia, allergy to PCN, dairy.			1						1	Blood pressure increased; Headache	FLU3~SANOFI PASTEUR~U2284AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0272098	02/12/2007	MA	56.0	55		M	02/05/2007	Injection site hot, hard and swollen. Swelling progressed down entire arm, unable to lift arm, watch band too tight to wear. Shake/fever 12/3/06 never had this before.									Y	12/02/2006	12/02/2006	0		PUB	PUB		NONE				1						1	Hypokinesia; Injection site induration; Injection site swelling; Injection site warmth; Oedema peripheral; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U2258AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0601F~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0272099	02/12/2007	MA	58.0	57		M	02/05/2007	Injection site hard, hot and swollen. Swelling progressed down entire arm unable to lift arm for 2 days. Gone after 4-5 days. Never had this type of reaction before.									Y	12/02/2006	12/03/2006	1	NONE	PUB	PUB		NONE				1						1	Hypokinesia; Injection site induration; Injection site swelling; Injection site warmth; Oedema peripheral	FLU3~SANOFI PASTEUR~U2258AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0601F~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0272100	02/12/2007	MA	65.0	65		F	02/05/2007	By morning right upper arm red, hot, swollen, swelling travelled down arm, difficult to use arm for about 2 days. never had that type of reaction before.									Y	12/02/2006	12/02/2006	0	NONE	PUB	PUB		NONE			MA0701	1						1	Hypokinesia; Injection site erythema; Injection site swelling; Injection site warmth; Oedema peripheral	FLU3~SANOFI PASTEUR~U2258AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0601F~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0272102	02/12/2007	AK	0.54	0	.5	M	02/09/2007	Rash which began after immunizations which started on head - spread over all the body. Red raised bumps. Itchy.				Y					U	02/07/2007	02/07/2007	0		PUB	PUB		NONE	NONE			1						1	Erythema; Pruritus; Rash generalised	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B069AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2175CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~808691A~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0272103	02/12/2007	CT	4.0	4		M	01/30/2007	Right arm swollen, red, painful.									Y	01/29/2007	01/29/2007	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Injection site erythema; Injection site pain; Injection site swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B040CA~5~UN~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~71032~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0421~4~UN~UN~POLIO VIRUS, INACT. (IPOL)~1|VARCEL~MERCK & CO. INC.~1151F~2~UN~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0272104	02/12/2007	OH	75.0	75		F		Pain in arm. Couldn't lift arm. Went to my doctor name, address and phone number reported.									Y	10/20/2006	10/20/2006	0		OTH	OTH						1						1	Hypokinesia; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0272107	02/12/2007	MI	0.76	0	.8	M	02/05/2007	Abscess. Required surgical drainage. Abscess at site of Pediarix injections. Similar reaction to PCV 8/11/06.									Y	01/05/2007	01/12/2007	7		PVT	PVT		NONE	NONE	ABSCESS~Pneumo (Prevnar)~2~0.33~In Patient		1						1	Abscess; Abscess drainage; Injection site abscess; Similar reaction on previous exposure to drug; Surgery	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B074AA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2312AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1015F~3~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08657F~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0272131	02/12/2007	AL	23.0	23		M	02/12/2007	pt. reported to civilian MD.  Larger area of erythema and color secondary to a meningococcal vaccine and was treated.									Y	01/21/2007	01/24/2007	3		MIL	MIL	No	No	No			1						1	Erythema	FLU3~SANOFI PASTEUR~U23108AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~SANOFI PASTEUR~U2136AA~2~SC~RA~MENINGOCOCCAL (MENOMUNE)~1|TYP~SANOFI PASTEUR~Z0663~4~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0272137	02/12/2007	UT	34.0	34		F	02/12/2007	Night after receiving vaccines, she started to run a fever and unable to move the arm.  Red knot on the right arm, went to ER and told her she had an allergic reaction and an infection in the muscle from the shot.  Gave her a steroid and an antibiotic.  Prednisone and Cephalexin.  Cephalexin was given for 1 week and then on the Prednisone for 4 days.  Had problems with that arm until Christmas.  She was diagnosed on 2-2-07 with Meniere's disease and she did notice about 3 days after the vaccination some ringing in her left ear and vertigo, minimal hearing loss.				Y					Y	11/22/2006	11/22/2006	0	None	PUB	PVT	No	No	Penicillin, Betadine, ASA, Morphine, Altran, Cipro, Lortab.  Has had breast cancer and uterine cancer 2001-2002.  Hystoplasmosis in 2003.  Surgeries: 1978 skin grafts on legs- stung by a scoripion, 1886 left ear lobe repair, 1988 rods placed in left hand, 1997 C-section, 2001 hysterectomy, 2002 lumpectomy for breast cancer, 2003 4 lung biopsies, 2004 2 tumors removed from lower back.			1						1	Deafness; Erythema; Hypersensitivity; Hypokinesia; Induration; Infection; Meniere's disease; Pyrexia; Tinnitus; Vertigo	FLU3~SANOFI PASTEUR~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~~1~IM~LA~HEP A (VAQTA)~1|PPV~MERCK & CO. INC.~~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0272156	02/12/2007	ME	57.0	57		M	02/09/2007	Numbness and burning of hands and feet EMG cannot rule out Guillain Barre. Neuro consult. Neurontin. 2 /15/07 Received medical records from PCP which included partial neuro records.  Letter faxed to neuro to request medical records.  PCP records reveal patient seen on 1/30/07 & had experienced numbness of hands & feet x 5 days.  Cold s/s had improved.  Exam revealed purplish fingertips which waxes & wanes.  Bottoms of feet now tingling.  Patient returned 2/1/07 & numbness & burning had intensified.  Gait & strength were WNL.  Dx by PCP w/sudden onset peripheral neuropathy.  Discussed w/neuro who felt could be GBS s/p flu vax on 1/12/07 & eval was arranged.  Tx w/neurotin.   Neuro consult reveals patient now complained of leg weakness & he had difficulty on stairs.  Intermittent blurred vision.  Exam revealed mildly weak toe extensors & DTRs absent in ankles bilaterally.  Decreased pinprick sensation bilaterally.  Tandem walking was slightly difficult.  Neuro felt possibly GBS but dx would depend on EMG/NCS & CSF studies. 2/26/07 Received medical records from neurologist which reveal patient initially seen 2/5/07 for numbness & tingling of hands & feet.  Returned 2/6/07 for LP & EMG/NCS.  Returned 2/13/07 & neuro felt exam unchanged.  FINAL DX: No definitive dx given but Neuro felt dx was asymptomatic diabetic neuropathy which became symptomatic due to flu shot rather than GBS.									U	01/12/2007	01/26/2007	14	TSH nl, Lyme neg, CSF neg, neg arsenic, mercury lead nl, EMG mild session dyneuropathy, tulnary median nerve neuropathy.  LABS: HgbA1C on 1/19/07 was 7.0.  EMG/NCS inconclusive & revealed compressive neuropathy of wrists & no convincing evidence to suggest any acute demyelinating neuropathy. 2/6/07 EMG/NCS revealed compressive neuropathy of median nerve at left wrist & no convincing evidence to suggest acute demyelinating neuropathy.  LABS: WBC 6.96, possible abnormal immunoglobulin.  CSF showed protein 50 & glucose 90, both slightly elevated.	PVT	PVT		NONE	Diabetes x 1 year HGBUC 7.0 Family Hx: patients mother had GBS. PMH: HTN, NIDDM, gout, hyperlipidemia.			1						1	Blood lead normal; Blood mercury normal; Blood thyroid stimulating hormone; CSF culture negative; Electromyogram; Hypoaesthesia; Lyme disease; Neuropathy; Skin burning sensation	FLU3~SANOFI PASTEUR~U2164AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0272161	02/13/2007	GA	84.0	84		M	01/16/2007	Upon awaking around 8am on Oct 24, patient could not sit up or stand or walk. His speech was garbled for several hours. When doctor (nurse) returned call, he was sent by ambulance to local hospital. Spent 6 hrs in ER, then admitted to a room (for 7 days) and then to nursing home. (Still There). Still unable to stand or walk. 02/21/07-records received and reviewed for DOS 10/24-10/30/06.C DX: acute pneumonia possibly secondary to aspiration although the patient is a poor historian. Leukocytosis with white count 30,000. Abdominal aortic aneurysm. Alzheimer's dementia. Presented with acute mental status change, leukocytosis, fever. Per information received from annual follow up has weakness. Patient had Alzheimers and hard to determine that contribution to problem with recovery. (Pt ultimately dides in NH).				Y	Y	6			N	10/23/2006	10/24/2006	1	Pt admitted to medical center.MRI cervical spine: degenerative disc disease at C66-7 with small osteophytes. MRI lumbar spine-L5-S1 degenerative changes. CT abdomen with contrast-bilateral pleural effusion right greater than left. Atelectasis with mild consolidation at right lung base. Lesser degree of atelectasis at left lung base. Aorta markedly abnormal aneurysm involving the right common iliac artery with dilatation at level of diaphragmatic hiatus. Cholelithiasis. MRI Brain: diffuse cortical atrophy with microvascular ischemic changes in periventricular white matter more pronounced than on previous exam of 11/13/01. CT Brain: no acute infarcts or bleeds. Atrophy. Blood culture no growth.	PVT	PVT	Exelon, Namenda 10 mg and Effexor XR 75 MG	NONE	Alzheimer's Disease			1						1	Abasia; Aortic aneurysm; Asthenia; Computerised tomogram abdomen abnormal; Computerised tomogram normal; Dementia Alzheimer's type; Dysstasia; Mental status changes; Pyrexia; Speech disorder	FLU3~SANOFI PASTEUR~U2168DA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0272162	02/13/2007	WI	63.0	63		F	02/07/2007	Generalized symmetrical weakness with peripheral paresthesia leading to dysphagia and compromised respiratory status. DX Guillain Barre, acute.  02/15/07-Records received with VAERS report for a 2 day hospital stay for pt. c/o progressive weakness, numbness and tingling in fingers and feet.  She progressed to being unable to feed herself, transfer in  bed or ambulate.  PE: WNL except Muscle strength decreased. Grip stength decreased. Unable to lift arms greater than 45'. Discharge DX: Generalized symmetrical weakness with peripheral paresthesias presumed to be due to acute Guillain Barre Syndrome.  Transfered to another facility for management and neuro. consult. 3/31/2010 Follow up: Making steady slow progess. I am writing to you regarding patient, who has previousl been a patient. By way of summary, I saw patient at hospital as an inpatient in December of 2006, she was suffereing from progressive weakness of muscles. I diagnosed her as having Guillian Barre syndrome and she was subsequently transferred for continued care. She had a rather stormy and difficult course while she was there, but ultimately was transferred back for nursing home rehabilitation with, as I understanding it, the plan to return to the move aggressive inpatient physical therapy program. Patient has made really quite significant progress since returning to care center. I know that she was evaluated perhaps a month or six weeks ago and felt to not have made enough progress at that time to participate in the comprehensive inpatient program. I do feel that she has now continued to make excellent progress. She has reached the point now where she can be in a regular wheelchair all day, she can position herself independently from side-to-side, iss able to do forward, backward movements independently. She can get her feet on and off the foot pedals independently, can move the foot rest out of the way on her ownn. She has independent wheelchair mobility throughout the nursing home facility. She has now full active range of motion in all lower extremity motions except for straight leg raises and diminished dorsiflexor strength. She transfers via an EZ-stand and can transfer in physical therapy with moderate assistance of one and uses her platform front wheeled walker. She can sit and stand with just mild assistance. She tolerates intensive physical therapy for 60-90 minutes and the physical therapist feels she could tolerate more, but staffing limits at the home limits her to shorter sessions twice a day. She walk with a platform front wheeled walker, minimal assistance of two. She has bilateral ankle/foot orthotics. She can cover distances of 20-30 feet before resting. She ahs some problems with foot control and decreased proprioception. She has some difficulty with knee hyperextension, but is making steady progress. The patient's speech has made significant progress, she is now easy to understand with a fairly normal speech pattern. This contrasts to January when she could only tolerate a reclining Geri-chair for short periods of time, she got dizzy when she sat up, she had very little active movement in any joints. She was totally dependent on transfers and was generally extremely fatigued. She was unable to do any weight bearing. We are very interested in getting her involved in a more aggressive and complete therapy setting and would very much like to see her admitted to your comprehensive inpatient therapy program. At this point, the patient is very highly motivated and is very anxious to become more involved in rehabilitative therapy. We feel she has made excellent progress and will continue to make super progress.				Y	Y	32			N	11/09/2006	12/03/2006	24	Heat CT negative. Labs and Diagnostics:  PFTs showed significant compromise and reduction of forced vital capacity, FEV, FEV1, and FEF25/75.  EKG-normal. CT showed no evidence of stroke.  Initial K was low at 3.1 which rose to 4.2 prior to d/c. Hgb 15.6, TSH 0.7, glucose 179, creatine 1.1. CKMB-normal. Troponin 0.  Morning cortisol level was 13.5. CRP 1.1. Immunoprotein electrophoresis showed no specific diagnostic pattern. Vit D normal.	PVT	PVT	Requip, Dyazide, Benazepril, Metoprolol XL, Wellbutrin, Synthroid, Lovastatin, Aspirin, Albuterol, Advair. Meds: Nitroglycerine as needed.  Pergolide, Clonidine, Lotrel.		Allergies PCN, Bactrim. Hypertension, CAD, Hypothyroidism, Angioplasty with stent placement, CVA, restless leg syndrome, COPD.			1						1	Asthenia; Computerised tomogram normal; Dysphagia; Guillain-Barre syndrome; Paraesthesia; Respiratory disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601211~4~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0272164	02/13/2007	WV	1.02	1	.0	F	02/12/2007	MMRV given 1/31/07 seen 2/9/07 rash probably from measles fine rash. Seen again 2/12/07 rash now confluent. Probably from measles.				Y					N	01/31/2007	02/09/2007	9	NONE	UNK	UNK	Amox, HCT cream, Benadryl	exudate nose, rash on buttock	NKA			1						1	Measles; Rash	FLU3~SANOFI PASTEUR~U2271~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1194R~1~IM~RL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~0832F~1~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08635K~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0272167	02/13/2007	RI	0.53	0	.5	M	02/08/2007	On the following 2 nights (2/6/07 and 2/7/07) he had episodes of gasping along with tonic-clonic movements of arms and legs, resolved when awoken by his mother, followed by crying. No cyanosis No fever on 2/5/07.									U	02/05/2007	02/06/2007	1	NONE	PUB	PUB	NONE	NONE	Eczema			1						1	Crying; Dyspnoea; Tonic clonic movements	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B084BA~3~IM~~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2271AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B36258A~3~IM~~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0607F~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0272169	02/13/2007	IL	70.0			F	02/06/2007	In the fall of 05' I located the 1st flu immunization clinic in our area. (It was either late Sept or early Oct). I asked for it to be given in my left arm, but they preferred my right and did it there. Immediately a deep surge of pain followed thru my arm so hurtful I moaned aloud. The injection site stayed swollen and red for many weeks and hot to my touch. From the time of the injection in 05' till Jan '07 intense throbs of pain accompanied by nausea occurred. It emenated from deep in the tissues under the injection site and went to my shoulder and down to my elbow. For about the first year that occurred dozens of time a day, then for these last few months got less and less. Two weeks ago was the last occurrence. I told all my friends about it, but I don't remember that I discussed it with my family physician. I'm the eternal optomist and kept telling myself,  It will eventually ho away; it's not going to last forever, and what could my doctor do about it anyway?. Another reason I didn't mention it to our family physician is because my office visits already cost $130 and anytime I mentioned another area of concern the cost rose. Our supplemental insurance does not cover doctor's visits, so my co-pay amount increased.									Y					PUB	UNK			allergic to IVP dye and morphine; have high blood pressure and diabetes, gastric reflux	really ill and in bed 3 days~Influenza (Seasonal) (no brand name)~~33.00~In Patient		1						1	Injection site erythema; Injection site swelling; Injection site warmth; Moaning; Nausea; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0272171	02/13/2007	TN	14.0	14		M	02/06/2007	I gave Infanrix to a child over 7 years old instead of Adacel. No symptoms while in clinic.										02/06/2007	02/06/2007	0		PUB	OTH	NONE	NONE	NONE			1						1	Inappropriate schedule of drug administration; Wrong drug administered	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B033AA~6~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2292AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0272172	02/13/2007	TN	11.0	11		M	02/06/2007	I gave Infanrix to a child over age 7yrs instead of Adacel. No symptoms while in clinic.										02/06/2007	02/06/2007	0		PUB	OTH		Ear infection				1						1	Inappropriate schedule of drug administration; Wrong drug administered	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B033AA~6~IM~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2292AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2171AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0272183	02/13/2007	NC	1.0	1	.0	F	01/12/2007	Pt developed a rash on face and left arm, left thigh and left leg the following day after vaccines given.  No fever. ? allergic reaction to ibuprofen or food coloring in med vs ?viral exanthem.									Y	12/18/2006	12/19/2006	1		PVT	UNK		no diaper rash			NC07012	1						1	Rash	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B065AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AF1UA216AA~1~IM~LL~INFLUENZA (SEASONAL) (FLULAVAL)~1|HIBV~MERCK & CO. INC.~U60R~3~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08635K~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0272193	02/13/2007		60.0	59		F	02/12/2007	Information has been received via another manufacturer and from a 60 year old female with multiple sclerosis (diagnosed in September 1998). This patient initiated secondary suspect interferon beta-1a (REBIF) therapy for multiple sclerosis on 01-JUL-2002 and administered 44 mcg three times a week by subcutaneous injection. On 03-NOV-2006, the patient was vaccinated into the right arm with Pneumovax 23 and influenza virus vaccine (unspecified). Concomitant therapy included tolterodine tartrate (DETROL LA). On 04-NOV-2006, the patient had an infection at the injection site of the Pneumovax 23 vaccination on her right arm. The patient had fallen because she was so weak and was hospitalized on 04-NOV-2006. The patient was treated with SOLU-MEDROL and unspecified antibiotics. The patient was discharged on 05-NOV_2006. As of 19-JAN-2006, the patient's injection site infection from a Pneumovax 23 shot was resolved and it was unknown if the patient recovered from the fall and weakness. Additional information is not expected.				Y	Y	0	Y		Y	11/03/2006	11/04/2006	1	UNK	OTH	OTH	REBIF; DETROL LA		Multiple sclerosis		WAES0702USA00849	1						1	Asthenia; Fall; Injection site infection	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0272203	02/13/2007	CA	3.0	3		F	02/13/2007	a)Patient's Crohn's Disease is diagnosed in Aug 2005. b)Remission achieved Dec 2005. c) Typhoid short in Jan 2006 before an overseas trip caused minor flare for 3-4 days starting Jan 26. 2006( See VAERS report E-14626 ). d) Dec 1, 2006, Hepatitis A and 2 Flu shots. e) Dec 16: Crohn's Disease Flared up again. Currently disease is highly active. Follow-up: Crohn's flare-up is still active. Steroid based treatment and colonoscopy have been prescribed and carried out. Disease is highly active for past 5 months.			Y	Y					N	12/01/2006	12/16/2006	15	After Crohn's Disease flare up, constant testing and lab reports show classic disease flare up syptoms. High Sed rate, bloody stools, frequent bowel movements and abdminal pain.	UNK	UNK	Crohn's Disease Anti-inflammatory medications- sulfasalazine 5mlx3, Folic Acid 1mlx1	None except Crohn's Disease in remission.	Inactive Crohn's Disease( in remission ) at the time of shots.	Crohn's Flare up~Typhoid Vi Polysaccharide (Typhim Vi)~~2.20~Patient		1						1	Abdominal pain; Condition aggravated; Crohn's disease; Frequent bowel movements; Haematochezia; Red blood cell sedimentation rate increased	FLU3~SANOFI PASTEUR~U2220EA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1008F~2~IM~LL~HEP A (VAQTA)~1	USA	Life Threatening	Influenza
0272207	02/13/2007		1.1	1	.1	M	02/13/2007	This male subject was enrolled in the prophylactic single blind study. On 20 January 2007, he received the 1st and 2nd dose of influenza vaccine (Fluarix, IM Left deltoid). On 24 January 2007, four days after the 1st dose of Fluarix, this one year old subject experienced febrile seizure. Temperature 38.3 C 2 days prior. Subject was given paracetamol for upper respiratory infection symptoms. At approximately 5pm on 24 January 2007, had 2 minutes of left staring, frozen and arching back. He was active and alert by time arrived at emergency department. He received ibuprofen. He was discharged home on 24 January 2007 at 6:35 pm. He was seen on 25 January 2007 in pediatrician office for follow up. Diagnosis was febrile seizure due to viral upper respiratory infection likely. He was alert, active. The event resolved on 24 January 2007. The investigator considered that there was a reasonable possibility that the febrile seizure may have been caused by influenza vaccine and that the event was possibly due to viral upper respiratory infection.				Y					Y	01/20/2007	01/24/2007	4	Body temperature: 38.3 C	OTH	OTH		UNK			B0457863A	1						1	Body temperature increased; Febrile convulsion; Opisthotonus; Pyrexia; Staring; Upper respiratory tract infection; Viral infection	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0259064	02/14/2007	OR	55.0	54		M	02/14/2007	Patient contacted the facility on 27 Jun 06 to report a change in his condition. On 20 Apr 06 he was vaccinated with Hep B #1, and the influenza vaccine. He stated that since the first part of May 06 he started to experience a relapse in his fatigue. He stated it was at though he had shut down mentally; he could not think straight, speech was slow and he could not get out of bed. He also noted headaches, especially in the front part of his head. He stated that he was also depressed and noticed some tingling in his shoulders and hands. He stated he saw a psychiatrist who then requested a MRI. The MRI showed extensive white lesions in his brain and he was then referred to neurology. He subsequently received a second opinion with neurology at medical center on 19 Dec 06. Currently, he states he is going on his current medication regimen, and notes improvement in his thought process. His wife stated that she also notes a great improvement in his thought process. He denies any physical weakness, decrease strength or altered sensations and reports that the headaches have decreased significantly. Fatigue, malaise > 60 days 05/2006, Depression 05/2006, Paresthesia 05/2006, Headache, general 05/2006, Cognitive deficiency 05/2006.  2/22/07 Received medical records which reveal patient experienced severe depression, single manic episode and was evaluated by psych in Oregan who referred patient to neurologist after +MRI.  Neurology consult done 12/06 & 1/07.  To be followed serially w/MRIs to monitor resolution/progression.  FINAL DX: ADEM associated w/anthrax vax;mood disorder, bipolar type, & cognitive dysfunction secondary to general medical condition.				Y						04/20/2006	05/01/2006	11	Jun 06: MRI of brain without contrast - mod diffuse cerevral leukoencephalopathy. The appearance is nonspecfic. No evidence of acute infarct or ischemia by diffusion weighted imaging 19 Dec 06 MRI BRAIN 1. Extensive whitter matter T2 hyperintensities as described above. These do not show evidence of mass-effect or abnormal enhancement. In immunocompromised patient's this can be seen with HIV encephalopathy. This can also be seen with progressive multifocal leukoencephalopathy. Leukoencephalopathy from previous toxic or metabolic abnormality including hypothyroidism as well as leukoencephalopathy associated with vaccinations can have this appearance. This can be seen as confluent white matter disease associated with small vessel ischemic changes. The widespread involvement would make multiple sclerosis or other primary demyelinating lesions less likely. 2. Developmental venous anomaly within the left frontal lobe. Labs: 20 Dec 2006: CSF: Reagin Ab NON-REACTIVE; Borella burgdorferi Ab 0.2; Borella burgdorferi Ab Index UID; Albumin 54.0 (H), Albumin 4.7; IgG Index 0.51; IgG Synthesis +0.2; IgG 6.4; IgG1100; Ollgocional Bands NO BANDS; Myelin Basic Protein <2.0; glucose 57; protein 74 (H); color Colorless appearance CLEAR; RBC's 1; Nucleated Cells; Lymphocytes 80; Monophage 16; Neutrophils Segmented 1;  LABS: MRI of head reveled extensive white matter lesions.  LP 8/04 showed protein 80, glucose 56, WBC 2, RBC 1.  Repeat LP 7/06 revealed protein 85, glucose 53, WBC 4.  LP repeated 12/06 & revealed protein 74, glucose 57, WBC 2.  Oligclonal bands were neg on all LPs.	MIL	MIL	Dlltia XT 240 MG, Lipitor 40 mg		Bells palsy, HTN, Elevated cholesterol, Nephrolithiasis, Renal failure secondary to tubular interstitial nephritis (resolved), chronic iritis/uveitis PMH: left Bells palsy, 7/04 preceeded by viral illness; abnormal taste & smell sensations since 7/04.  Chronic headaches, uveitis/iritis.  diffuse myalgias; renal failure, significant weight loss, mild transaminitis; tubular interstitial nephritis.  HTN, HLP, nephrolithiasis.	chronic idiopathic iritis, bells palsy, headaches, arthralgiaas and myalgias~Anthrax (no brand name)~3~52.00~In Patient		1						2	Blood albumin increased; CSF test abnormal; Cognitive disorder; Depression; Fatigue; Headache; Leukoencephalopathy; Malaise; Nuclear magnetic resonance imaging abnormal; Paraesthesia; Red blood cell abnormality; Speech disorder	FLU3~SANOFI PASTEUR~U1911AA~2~~~INFLUENZA (SEASONAL) (FLUZONE)~2|HEP~MERCK & CO. INC.~AHBVB166AB~1~IM~~HEP B (RECOMBIVAX HB)~2	USA	Emergency room visit	Influenza
0270955	02/14/2007	CA	41.0	41		M	02/14/2007	Raised red area on Left Axilla, soreness lasting more than 24 hours. Kaiser advised to apply warm compress. Resolved without additional treatment x 4 days.				Y					Y	12/15/2006	12/18/2006	3	None. Advise only	PVT	PUB	Lisinopril, HCTZ	None	Hypertension			1						2	Axillary mass; Injection site nodule; Skin warm; Erythema; Pain	FLU3~SANOFI PASTEUR~U2272AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~02272AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0272221	02/14/2007	WI	50.0	50		F	02/14/2007	Patient called in today stating that she started to develop fever/chills, headache, myalgias, fatigue, and increased thirst on 2-9 (2 days after receiving the typhoid and influenza injections).  She reports that symptoms have persisted, although today the headache has resolved and she is starting to feel better.									U	02/07/2007	02/09/2007	2		PVT	PVT	vicodin prn, aleve, alprazolam prn, nadolol	none	none			1						1	Chills; Fatigue; Headache; Myalgia; Pyrexia; Thirst	FLU3~SANOFI PASTEUR~u2286aa~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~SANOFI PASTEUR~z0664~1~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0272222	02/14/2007	TX	0.5	0	.5	F	02/14/2007	pea size nodule after one month of administration									U	01/08/2007	01/08/2007	0	none	PVT	PUB	none	none	none			1						1	Nodule	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~ac21b079aa~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~u2191ca~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~ue992aa~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~b08682e~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1113f~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0272240	02/14/2007	TX	2.0	5		F	11/02/2006	Generalized  macular papular rash on body.									Y	11/02/2006	11/02/2006	0		PVT	OTH				urticaria~Varicella (Varivax)~0~1.00~In Patient	TX07006	1						1	Rash maculo-papular	FLU3~SANOFI PASTEUR~U2192AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0272242	02/14/2007	NY	75.0	75		F	02/09/2007	On way home from shot my arm turned bright red-then hives all over my body. Administered Atarax-Cephlin to counteract reaction-given by my doctor.  Could not tolerate this medications after going off this my body broke out like measles all over and a rash on top of that and extemity itchy and then bled an awful situation.									N	11/20/2006	11/20/2006	0	blood tests and nutritional review showed liver stress	PVT	UNK		NONE	NONE	1957~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Blood test; Erythema; Liver function test abnormal; Pruritus; Rash; Rash morbilliform; Skin haemorrhage; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0272247	02/14/2007	AZ	44.0	44		F	02/14/2007	Brachial Plexus neuritis.  2/16/07 Received medical records from reporter/provider which reveal patient experienced immediate pain at time of vax within the left shoulder girdle extending down into the elbow & into the scapular region.  Had neuro evals x 2: 1/2/07 Neuro eval revealed continued difficulty with external rotation of left shoulder girdle, forward flexion & extension.  Sleep was affected.  Exam revealed mild weakness of suprascapular innervated nuscles, axillary innervated muscles & borderline long thoracic nerve weakness.  DTRs were 1/5 & symmetrical.  Decreased pinprick in axillary nerve distribution.  FINAL DX: left brachial amyotrophy involving both suprascapular & axillary nerves, most likely autoimmune; & perimenstrual migraines w/probable comorbidities. EMG & MRI were recommended.  Placed on steroids. 2/6/07 2nd Neuro eval revealed complaints of gradual buildup of pain in left deltoid w/swelling & discoloration & pain moved up into shoulder blade as shooting pain w/certain movements.  Left arm weakness as well as pain.   Patient had not done the EMG/NCS or MRI as recommended.  Exam revealed no tenderness to palpation of left arm or shoulder w/full ROM & no scapular winging.  There was a mild difference in pinprick sensation in left axillary nerve distribution. FINAL DX: probable left brachial plexus neuritis, mild, most likely idiosyncratic immune mediated reaction to flu vax.  Recommended to avoid flu shots in future.  OT was recommended.  Patient deferred EMG/NCS.   FINAL DX of 2 neurologists: left brachial plexus neuritis, most likely idiosyncratic immune mediated reaction to flu vax.									Y	11/22/2006	11/22/2006	0	Neurological evaluation	PVT	UNK		NONE	PMH: Hashimotos thyroiditis. Low back pain. Headaches, sinus problems, gastritis, restless sleep w/parasomnias.			1						1	Neurological examination; Radiculitis brachial	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71216~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0272248	02/14/2007	LA	7.0	7		M	02/14/2007	Flumist given 2/14/07 had expired 2/11/07. No adverse events have occurred.										02/14/2007				PVT	PUB		NONE	NONE			1						1	Expired drug administered; No adverse effect	FLUN3~MEDIMMUNE VACCINES, INC.~500434P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0272265	02/15/2007	IA	4.0	4		F	02/14/2007	2/14/07 Mother called in child has a reddened ring around the injection site approximately 1 inch in diameter. Child complain of itching of entire arm. Mother called doctor's office per RN request. Office recommended use of cortisone cream.										02/09/2007	02/13/2007	4		PUB	PUB		NONE	No known allergies. Has asthma - takes albuterol PRN wheezing			1						1	Injection site erythema; Pruritus	DTAP~SANOFI PASTEUR~U1774CA~4~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2283AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~0831F~2~SC~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0272268	02/15/2007	AR	1.05	1	.1	F	01/04/2007	Parents report temp 110 degrees had generalized shaking was given one shot, Tylenol, and prescription for 1 dose qd for 5 days. Seen at facility.  4/13/07 Received medical records from hospital which reveal patient seen in ER on 12/10/06 for possible febrile seizure, nasal congestion & ear pain w/vomiting x 1.  Temp 102.6.  TM's distended, right greater than left.  Anterior lymphadenopathy present bilaterally.  Given antibiotics in ER & upon d/c. FINAL DX: Febrile seizure, right otitis media.				Y					Y	12/04/2006	12/09/2006	5	NONE	PUB	UNK		NONE	NONE		AR0712	1						1	Body temperature increased; Tremor	FLU3~SANOFI PASTEUR~U2174KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE885AA~4~IM~RA~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~1027F~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08675E~4~IM~RA~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1060F~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0272274	02/15/2007	NC	1.0	0	1	F	02/14/2007	Initial and follow up information has been received from a physician and an office manager concerning a 12 month old white female patient with no past medical history who on 15-DEC-2006 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant vaccinations on the same day included a first dose of measles-mumps-rubella vaccine (MSD) SC into the left leg, Hib conj vaccine (OMPC) (manufacturer unknown) and a first dose of varicella virus vaccine live (MSD) SC into the left leg. Other concomitant vaccinations included a first dose of influenza virus split virion 3v vaccine inactivated (FLUZONE) (lot# 427U7AA) IM into the right leg. It was reported that the patient received HPV rL1 6 11 16 18 VLP vaccine (yeast) by accident.  She was supposed to receive a dose of pneumococcal 4 6B 9V 14 18C 23F conj vaccine (CRM197) (PREVNAR). The reporter stated that the products were clearly labeled; there was not a confusion of products.  It was lack of education of the medical assistant working on the office.  The parents reported the patient had slight fever on 16-DEC-2006 (also reported as the 17-DEC-2006).  Subsequently, the patient was seen in the office on 18-DEC-2006 and had recovered from slight fever. There were no there reported problems or any other adverse events. Additional information is not expected.									Y	12/15/2006	12/15/2006	0	Test, Date, Value, Unit, Normal Range, Comment-body temp, 12/17/06, slight fever	PVT	PVT			NONE		WAES0612USA02803	1						1	Inappropriate schedule of drug administration; Pyrexia; Wrong drug administered	FLU3~SANOFI PASTEUR~427U7AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~~UNK~~~HIB (PEDVAXHIB)~1|HPV4~MERCK & CO. INC.~~UNK~~~HPV (GARDASIL)~1|MMR~MERCK & CO. INC.~~1~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~~1~SC~~VARICELLA (VARIVAX)~1	USA		Influenza
0272276	02/15/2007	NY	12.0	12		F	02/14/2007	Information has been received from a physician concerning a 12 year old female with no illness at the time of vaccination who on 08-DEC-2006 was vaccinated with a 0.5 ml first dose of Gardasil (yeast) (lot 653938/0954F). On 08-DEC-2006, the patient was concomitantly vaccinated with a first dose of Menatra, a dose of influenza virus vaccine (unspecified) and a dose of Boostrix. On 08-Dec-2006, the patient fainted shortly after vaccination. She fell from a standing position and hit the back of head on the floor. She was unconscious for approximately 30 seconds,a and then was dazed and pale. The patient was ok after a few minutes. The patient complained of a headache, frontal to occipital. The patient was ok at home later that evening. The patient recovered with no sequalae on 08-DEC-2006. Additional information is not expected.				Y					Y	12/08/2006	12/08/2006	0	NONE	PVT	PVT			UNK		WAES0701USA00266	1						1	Fall; Feeling abnormal; Headache; Injury; Loss of consciousness; Pallor; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~0954F~1~~UN~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~~1~~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~UN~TDAP (BOOSTRIX)~1	USA	Emergency room visit	Influenza
0272355	02/15/2007	NY	13.0	13		F	02/14/2007	Information has been received from a physician's assistant concerning a 15 year old female who on unspecified dates was vaccinated intramuscularly in the arm with the first and second dose of Gardasil. Within 24 hours of receiving the first and second dose of Gardasil the patient developed a localized rash on the forearm. It was reported that the patient went to a dermatologist for the rash. It was reported that the events disappeared after a day or so. At the time of this report, the patient had recovered from the event (date unknown). Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Information has been received from a physician's assistant concerning a 14 year old female with acne vulgaris who on 26-OCT-2006 was vaccinated intramuscularly in the left arm with the first dose of GARDASIL (653978/0955F). Concomitant therapy included the influenza vaccine. On 15-NOV-2006 and the 16-NOV-2006, the patient was seen in the physician's office with a rash on the left forearm with red, raised, tender patches. The patient used NEOSPORIN and was referred to a dermatologist. On 17-NOV-2006, the patient was seen by a dermatologist. A punch biopsy of the left dorsal forearm was done which was consistent with an irritant contact dematitis. The patient subsequently recovered. On 27-DEC-2006, the patient was vaccinated with the second dose of GARDASIL (655165/1425F). On 30-DEC-2006, the patient developed the same type of rash on her right leg. The rash lasted two weeks and then resolved spontaneously. Additional information is not expected.				Y					Y	10/26/2006	11/15/2006	20	Skin biopsy, 11/17/06, irritant contact dermatitis	OTH	OTH	UNK	Acne vulgaris	UNK		WAES0701USA02415	1						1	Biopsy skin; Dermatitis contact; Rash; Rash papular; Vaccine positive rechallenge	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~0955F~1~IM~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0272359	02/15/2007	TX	0.51	0	.5	M	02/15/2007	At 2:45 child received 4 vaccines: Pediarix and Hib in right thigh, influenza and PCV7 in left thigh.  At 3:00 mom returned to clinic with child in arms and reported appearance of rash.  Upon inspection, irregular and reddenned areas were noted on face, left ear, and back of neck.  3 visible hives present at approximately 5x2, 4x2, and 4x2 mL in size.  Left thigh appeared red around both injection sites, but no swelling noted.  No signs or symptoms of distress.  Respirations within normal limits.  Happy and content in mother's arms.  At 3:05, RN drew up 1.25 mL of children's benadryl per protocol and mother administered.  At 3:15 redness had diminished and hives were no longer well defined.  Staff consulted for doctor's appointment which was scheduled immediately with Dr. at Clinic.  Mother sent to Dr. with shot record, report of incident, and a map to the clinic.  Child left in mother's arms, smiling and content.				Y					Y	02/07/2007	02/07/2007	0	DR. CALLED NEXT DAY AND STATED THAT UPON ARRIVAL TO OFFICE CHILD'S REACTION HAD COMPLETELY RESOLVED.	UNK	MIL	CHILDREN'S BENADRYL	NONE	NONE			1						1	Erythema; Injection site erythema; Rash; Urticaria	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B079AA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2191CA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE988AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B08674C~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0272364	02/15/2007	LA	0.8	0	.8	F	02/15/2007	Patient had a high fever from the first shot (administered 12/27/06) of 100 degrees F. The degrees of the fever fluctuated between 100-102 degrees F. It did not end in the 1-2 days (proposed by the Inactivated influenza Vaccine handout 2006-07).It lasted for a week. Also, the patient's behavior was out of the ordinary.									Y	12/27/2006	12/28/2006	1	none	PVT	UNK	none	none	Thought (according to physician at time of birth) to have an issue with hip bone because of mother's cesarian section. But after visits to a Bone and joint Specialist, everything was deemed okay.			1						1	Abnormal behaviour; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0267624	02/16/2007		62.0			M	02/16/2007	This case was reported in a literature article and described the occurrence of Guillain Barre syndrome in a 62-year-old male subject who was vaccinated with Influenza vaccine, manufacturer unspecified) for prophylaxis. The patient has a history of hypertension and alcoholic liver cirrhosis, for which he underwent orthotopic liver transplantation 6 months prior to admission. Since then, he had been on FK506 and a low dose of prednisone without any complications. He denied any precedent episodes of diarrhea, nausea, vomiting, or other gastrointestinal or upper respiratory illness. On an unspecified date the subject received unspecified dose of Influenza vaccine (unknown). Two weeks after vaccination with Influenza vaccine, the subject developed Guillain Barre syndrome. Subsequently he was hospitalized. Neurological examination on admission revealed normal mental status, bilateral facial weakness, dysphagia, hypophonia, quadriplegia (1-2/5 by agency reported scale) throughout, and absence of muscle stretch reflexes in all extremities. Blood chemistry showed blood urea nitrogen 34 mg/dL, creatinine 0.9 mg/dL, albumin 4.5 g/dL, aspartate aminotransferase 78 U/L, alanine aminotransferase 189 U/L, gamma-glutamyl transpeptidase 160 U/L, alkaline phosphatase 146 mg/dL, total bilirubin 1.8 mg/dL, direct bilirubin 0.5 mg/dL, ammonia 47 mol/L, international normalized ratio 0.91, and blood FK506 level 7 mg/mL. Serum immunoglobin G was positive against herpes simplex virus 1, Epstein-Barr virus, and cytomegalovirus (CMV) but negative against herpes simplex virus 2. Immunoglobin M was negative against Epstein-Barr virus and CMV in serum. The testing for Campylobacter jejuni was not performed. Lumbar puncture revealed that the cerebrospinal fluid looked xanthochromic with red blood corpuscles 0/mm3. white blood cells 1/mm3, protein 358 mg/dL, glucose 88 mg/dL, lactic acid 2.7 mEq/L, and opening pressure of 25 cm cerebrospinal fluid. Cerebrospinal fluid venereal disease research laboratory slide test, gram stain, cryptococcal antigen, and cytology were negative. Herpes simplex virus, CMV, and Epstein-Barr virus DNA were not detected by polymerase chain reaction test. Electrodiagnostic studies showed prolonged distal latencies and absence of late responses in all extremities. The component muscle action potentials were reduced throughout with absence of component muscle action potential in the proximal tibial and peroneal nerves bilaterally. The conduction velocities were reduced in the demyelinating range in the median nerves bilaterally. There was a conduction block in medial nerves bilaterally, in right ulnar and in right tibial nerves. These findings were consistent with acute inflammatory demyelinating polyneuropathy. Shortly after admission, the patient was intubated for airway protection and started on intravenous immunoglobulin 0.4 g/kg/day for 3 days without significant improvement. Plasma exchange was not considered because of the patient's unstable hemodynamic status. His hospitalization course was complicated by the development of ischemic colitis secondary to dysautonomia, for which he underwent subtotal colectomy. The patient expired 3 weeks after admission from septic shock and acute renal failure. The author considered that although the temporal relationship between GBS and influenza vaccination was suggestive of causal effect, it does not fully prove it. The cause of GBS in this case might be predominantly humoral dysregulation, triggered by influenza vaccination, although the possibility of the remaining cell-mediated immune reaction could not be completely excluded.	Y				Y				N				Blood chemistry showed blood urea nitrogen 34 mg/dl, creatinine 0.9 mg/dl, albumin 4.5 g/dl, aspartate aminotransferase 78 U/L, alanine aminotransferase 189 U/L, gamma-glutamyl transpeptidase 160 U/L, alkaline phosphatase 146 mg/dl, total bilirubin 1.8 mg/dl, direct bilirubin 0.5 mg/dl, ammonia 47 mol/l, international normalized ratio 0.91, and blood FK506 level 7 ng/ml. Serum immunoglobulin G was positive against herpes simplex virus 1, Epstein Barr virus, and cytomegalovirus (CMV) but negative against herpes simplex virus 2. Immunoglobulin M was negative against Epstein Barr virus and CMV in serum. The testing for Campylobacter Jejuni was not performed. Lumbar puncture revealed that the cerebrospinal fluid looked xanthochromic with red blood corpuscles 0/mm3, white blood cells 1/mm3. protein 358 mg/dl, glucose 88 mg/dl, lactic acid 2.7 mEq/l, and opening pressure of 25cm cerebrospinal fluid. Cerebrospinal fluid venereal disease research laboratory slide test, gram stain, cyptococcal antigen, and cytology were negative. Herpes simplex virus, CMV, and Epstein Barr virus serology IGM neg. VDRL negative.	OTH	OTH	Tacrolimus	UNK	Alcoholic liver cirrhosis, hypertension, liver transplant.		B0457987A	1						2	Alanine aminotransferase increased; Ammonia normal; Areflexia; Aspartate aminotransferase increased; Autonomic nervous system imbalance; Bilirubin conjugated increased; Blood albumin normal; Blood alkaline phosphatase normal; Blood bilirubin increased; Blood creatinine normal; Blood urea increased; CSF protein normal; Colectomy; Colitis ischaemic; Cytomegalovirus antibody negative; Cytomegalovirus antibody positive; Death; Demyelinating polyneuropathy; Dysphagia; Dysphonia; Epstein-Barr virus antibody negative; Epstein-Barr virus antibody positive; Facial paresis; Gamma-glutamyltransferase increased; Guillain-Barre syndrome; Intubation; Lumbar puncture abnormal; Neurological examination normal; Quadriplegia; Renal failure acute; Septic shock; Xanthoma	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Results in Death	Influenza
0271094	02/16/2007	CA	12.0	56		M	02/13/2007	Information has been received from a physician concerning a 12 month old male with no known allergies and a history of diaper rash and lacrimal duct obstruction who on 19-JAN-2007 was vaccinated in the left thigh with a dose of Zostavax (lot #654603/1405F) instead of ProQuad. Other concomitant vaccination given the same day included PedvaxHib (lot #652701/1008R), Prevnar and Fluzone. Subsequently the patient developed constipation and threw up once. Other wise he was doing okay, she reported that he is an active kid and no other changes were noted. The physician reported that the error was human error and not product confusion. The Zostavax was stored in the same box as ProQuad, the vial was picked up and administered to the patient without looking. The practice has since separated the vaccines.									N	01/19/2007	01/19/2007	0	NONE	OTH	OTH			Diaper rash, lacrimal duct obstruction.		WAES0701USA04097	1						2	Constipation; Vomiting; Wrong drug administered; Constipation; Inappropriate schedule of drug administration; Vomiting; Wrong drug administered	FLU3~SANOFI PASTEUR~UT2200PA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1008R~4~IM~LL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08675D~4~IM~RL~PNEUMO (PREVNAR)~1|VARZOS~MERCK & CO. INC.~1405F~1~SC~RL~ZOSTER LIVE (ZOSTAVAX)~1|FLU3~SANOFI PASTEUR~~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~MERCK & CO. INC.~1008R~UNK~~UN~HIB (PEDVAXHIB)~2|PNC~PFIZER\WYETH~~UNK~~UN~PNEUMO (PREVNAR)~2|VARZOS~MERCK & CO. INC.~1405F~UNK~~UN~ZOSTER LIVE (ZOSTAVAX)~2	USA		Influenza
0272398	02/16/2007	CO	28.0	28		F	01/16/2007	1/11/07 patient received inj (Fluzone) influenza vaccine. Patient reported adverse reaction to health dept on 1/16/07 c/o trouble breathing-use of own inhaler more often, hives/rash all over body-use of Benadryl cream.  Severe itching, on 1/19/07 seen by PCP-Dr, NP.  Rash better, breathing better, and no other treatments by NP, patient recovering.				Y					N	01/11/2007	01/11/2007	0	NONE	PUB	PUB	Albuterol neb inhaler, Norvasc, Nexium	NONE	asthma, GERD, anxiety, hypertension			1						1	Condition aggravated; Dyspnoea; Pruritus; Rash generalised; Urticaria	FLU3~SANOFI PASTEUR~U2251AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0272401	02/16/2007	PR	37.0	37		M		1. Permanent hypertension. 2. Stomach problems. 3. Brain disorder unknown causes.  3/19/07 Received medical records from VAMC which reveal patient experienced HTN for approx 13 yrs, traumatic LBP w/radiation to left leg since lifting heavy equip while active duty 2003 w/intermittent exacerbations, herpes labialis, heart murmur & hyperlipidemia/hypercholesterolemia, ETOH abuse.  Had been active duty for 15 mos in Iraq prior to being evaluated. Received multi sessions of PT for back pain w/good results. Had episode of vertigo in 11/06 following cold s/s which required hospitalization. Neuro consult revealed tandem gait ataxia. Final dx: benign positional vertigo vs vestibular neuronitis or viral labyrinthitis.  ENT/audiology w/u was WNL w/mild sensorineural hearing loss right ear & right vestibular hypofunction & patient referred for vestibular rehabilitation. Per annual follow up: Hypertension, articular pain (or joint), had suffered an acute CVA. I am sumitting a copy of my vaccination record with some of the manufacturer and lot number and the amount or cc administered.				Y	Y	1		Y	N	03/20/2003			LABS: EKG & echo were WNL.  LS spine xray revealed straightening of lumbar lordosis secondary to muscle spasms & transitional vertebra w/lumbarization of S1.  EMG/NCS were WNL.  MRI of LS spine revealed DDD.  Head CT scan revealed lacunar infarct.  Brain MRI was WNL.  Carotid duplex was WNL.	MIL	MIL		NONE	NONE PMH: HTN.			1						1	Arthralgia; Cardiac murmur; Cerebrovascular accident; Hypertension; Hypoacusis; Scan brain	ANTH~UNKNOWN MANUFACTURER~~UNK~~~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|SMALL~UNKNOWN MANUFACTURER~~UNK~~~SMALLPOX (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~~TETANUS TOXOID (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0272403	02/16/2007	MA	15.0	1	.3	M	02/11/2007	Rash developed papulovesicular for 2 days 2/10 and 2/11/07										02/01/2007	02/10/2007	9	NONE	PVT	PVT	Amoxicillin	Ear infection	NONE			1						1	Rash papular	FLU3~SANOFI PASTEUR~U2198AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0223F~3~IM~RA~HEP B (RECOMBIVAX HB)~1|MMRV~MERCK & CO. INC.~0975F~1~SC~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0272404	02/16/2007	WI	2.0	3		M	02/05/2007	2-1-7 2 size redness with brown center at injection site. No hard not hot, no pain. 2-2 Benadryl for same signs/symptoms-cancelled MD appt. 2-5 at MD appt 4 x 5 cm area of swelling, redness with sloughing of skin in stellate pattern.  No signs/symptoms infection				Y					Y	01/30/2007	02/01/2007	2		PVT	UNK		asthma, hypoxia				1						1	Injection site discolouration; Injection site erythema; Skin exfoliation; Swelling	FLU3~SANOFI PASTEUR~UT2175AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0272405	02/16/2007	OR	58.0	58		F		Reaction to vaccine-emergency hospital treatment				Y					Y	01/03/2007	01/03/2007	0		OTH	PVT			POK, Sulfa, Baclofen, Tzidine, eggs, dostin drugs			1						1	Vaccination complication	FLU3~SANOFI PASTEUR~112218AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0391F~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0272406	02/16/2007	LA	56.0	56		F	12/14/2006	Left arm swelled down to wrist. Pt saw private physician who put her on steroids and antibiotics				Y					Y	11/29/2006	11/30/2006	1		PUB	PUB		NONE	NONE		LA070201	1						1	Oedema peripheral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AF1uA240BA~7+~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|HEP~MERCK & CO. INC.~0688R~1~IM~RA~HEP B (FOREIGN)~1|HEPA~MERCK & CO. INC.~0501R~1~IM~LA~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0272428	02/16/2007	IN	49.0	48		F	02/16/2007	The patient's problems started about 5 to 6 days ago when she started having some spasms in the back with some numbness, tingling in the legs. She did see a neurosurgeon who ordered MRI of the thoracic spine and the lumbar spine. This appeared to be essentially unremarkable, slight pinching of the sacral sac. While this was going on, she started having more and more weakness and numbness in the legs. She went to the emergency room. She was given pain medication and was sent home. She got worse, went to the emergency room and again was treated with pain medication Norflex and anxiety medication that seems to make her feel a little bit better. She went home and then was unable to walk unsteady. On examination she was found to have no deep tendon reflexes in the lower legs and sensory level to L1. Myelopathy or AIDP diagnoses was made and she was immediately admitted now with neurology consultation. Further work-up will be done here immediately. The patient who is well known to me has no previous neurological problems. She has been treated in the past for hypercholesterolemia but otherwise the labs essentially have been normal. She has been in good health. She is up-to date with her DEXA scan which shows mild osteopenia. She is very active. She had hysterectomy in 2002. Otherwise she has absolutely no medical or surgical problems. She does take vitamins at home. Otherwise, no other pertinent medical/surgical history. Within the last 24-48 hours she has also developed acute left facial palsy. She complains of marked tingling, numbness, hyperesthesias both legs as well as tips of her fingers.  02/19/2007 VAERS report received with accompanying medical records (H&P, labs and diagnostics).  Made call to hospital to see if D/C Summary had been dicated yet, it has not.  TC to admitting MD who stated D/C DX was the same: Acute GBS, Acute left Bells' Palsy.  HPI: Two and 1/2 weeks after receiving flu vax. pt. began having back spasms and numbness/tingling in the legs.  Two ER visits over several days resulted in tx. with pain  meds, muscle relaxers, and anti-anxiety medication. Finally presented to admitting MD when she was unable to walk properly, gait unsteady.  C/o marked numbness, tingling, hyperesthesias of both legs as well as the tips of her fingers PE: No DTRs in lower extremities. Sensory level to L1.  Sensation is lost to the groin.  Gait unsteady and shuffling. On approx. 2/10/2007 she developed acute left facial palsy. Admitted to IMCU for Stat work-up.  Transfered to rehab after 3 days. Admission DX:  1) Acute Guillain-Barre Syndrome, AIDP, r/o CIDP 2) Acute left Bell's Palsy.  (MD states D/C DX is the same.) Per information received from annual, residual sensory and motor neurological symptoms legs & back, otherwise almost complete recovery. Return to work period including rehabilitative physical therapy of almost 1 yr duration.					Y	3			N	01/20/2007	02/06/2007	17	Labs and Diagnostics: EMG-shows eveidence of predominantly motor axonal polyneuropathy with some demyelinating features.  There are acute neuropathic changes seen on needle EMG.  F wave motor responses are prolonged.  This EMG does suggest a diagnosis of acute inflamatory demyelinating polyneuropathy.  Brain MRIs normal.  MRI cervical spine-small disc protusion at C6-7. and facet joint arthritic changes at C6-7. MRI of thoracic and lumbar spine-unremarkable.  ANA positive at 1:160. Serum protein electrophoresis-normal. CSF shows 2 RBCs, 1 WBC, culture-no growth. CBC normal. Chemistry normal. West Nile Virus IgG, IgM normal, Serum Protein E-normal. Sed rate normal. Immunoglob IgG 1280 (WNL). Immunoglob. IgA 223 (WNL).	PUB	OTH	Provided free to employees		none noted			1						1	Abasia; Bone densitometry; Chronic inflammatory demyelinating polyradiculoneuropathy; Facial palsy; Hyperaesthesia; Hyporeflexia; Muscle spasms; Muscular weakness; Myelopathy; Nuclear magnetic resonance imaging	FLU3~SANOFI PASTEUR~U2262AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0272449	02/16/2007	OK	39.0	39		M	02/16/2007	Onset of arthritic type pain in R arm/hand which moved to L hand arm several weeks later.  After hand symptoms subsided, same type of pain began in legs, first right then left.  Pain then moved to hips, at times severe enough that climbing stairs was difficult.  Symptoms have subsided for the most part.  Slight muscle weakness noted during worst of the pain.				Y					Y	10/16/2006	10/30/2006	14	Seen by PCP.  Lab studies drawn, but results still pending.	PUB	PVT	None	None	None	None~ ()~NULL~~In Patient		1						1	Arthralgia; Laboratory test; Mobility decreased; Muscular weakness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70737~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0272452	02/16/2007	TX	4.0	4		F	02/13/2007	RIGHT ARM SWOLLEN AROUND THE SHOULDER. ARM HURTS TO MOVE UPWARD, AND TO TOUCH ON THE SITE OF THE INJECTION. NO FEVER, DUE TO RECEIVE MOTRIN EVERY SIX HOURS AFTER SHOTS GIVEN.									Y	02/12/2007	02/13/2007	1	NONE	PUB	UNK	NONE	NONE	NONE			1						1	Injection site pain; Oedema peripheral; Pain in extremity	DTAP~UNKNOWN MANUFACTURER~U1819BA~4~IM~RA~DTAP (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U2283AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1209F~1~IM~LA~HEP A (VAQTA)~1|HIBV~UNKNOWN MANUFACTURER~UE857AA~4~IM~RA~HIB (NO BRAND NAME)~1|IPV~PASTEUR MERIEUX CONNAUGHT~Y2001-2~4~IM~LA~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0520F~1~SC~LA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|PNC~PFIZER\WYETH~B08682D~1~IM~RA~PNEUMO (PREVNAR)~1	USA		Influenza
0272702	02/16/2007	MN	13.0			F	02/13/2007	Information has been received from a physician and registered nurse concerning a 13 year old female patient who on 19-JAN-2007 was vaccinated IM in the right deltoid with a dose of Zostavax (lot#652947/1411F) instead of Gardasil. Concomitant vaccination on 19-JAN-2007 included influenza virus vaccine (unspecified). No adverse experiences were related to this event. On 20-JAN-2007 the patient returned and was vaccinated in the left deltoid with a dose of Gardasil (yeast) (lot#654510/0962F). The nurse reported that the vaccines were stored in separate bins which were clearly labeled and the wrong vaccine was selected by a new nurse. There was no product quality compliant involved. Additional information has been requested.									U	01/19/2007	01/19/2007	0	UNK	OTH	OTH			UNK		WAES0701USA03506	1						1	No adverse effect; Wrong drug administered	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~1411F~UNK~IM~~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0272457	02/17/2007	MN	3.0	3		M	02/17/2007	High fever, 102.9 Axilary, Vomiting. He is still running a temp of 101.5 in the morning of 2-18-07. Contacted the Dr. @ 1AM. Administering Tylenol.									U	02/16/2007	02/16/2007	0		PVT	PVT	None	None	None			1						1	Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0271991	02/19/2007	IL		0	.5	M	02/15/2007	None Stated					Y	4			Y	12/14/2006	01/26/2007	43		PVT	PUB						1						2	Intussusception; Rash; Vomiting; Unevaluable event; Intussusception; Rash; Surgery; Vomiting	RV5~MERCK & CO. INC.~1032F~3~PO~MO~ROTAVIRUS (ROTATEQ)~1|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B070AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~2|FLU3~SANOFI PASTEUR~U2243AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~MERCK & CO. INC.~02181F~2~IM~LL~HIB (PEDVAXHIB)~2|PNC~PFIZER\WYETH~B08675C~3~IM~RL~PNEUMO (PREVNAR)~2|RV5~MERCK & CO. INC.~~3~PO~MO~ROTAVIRUS (ROTATEQ)~2|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B070AA~UNK~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~3|FLU3~SANOFI PASTEUR~U2243AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~3|HIBV~MERCK & CO. INC.~0281F~UNK~IM~LL~HIB (PEDVAXHIB)~3|PNC~PFIZER\WYETH~B08675C~UNK~IM~RL~PNEUMO (PREVNAR)~3|RV5~MERCK & CO. INC.~~UNK~PO~MO~ROTAVIRUS (ROTATEQ)~3	USA	Hospitalisation	Influenza
0272538	02/19/2007	IL	80.0	80		F	02/19/2007	This case was reported by a pharmacist and described the occurrence of sore arm in an 80-year-old female subject who was vaccinated with FluLaval for prophylaxis. The subject had no adverse events following receipt of prior immunizations. On 24 October 2006 the subject received unspecified dose of FluLaval in the right arm. Within approximately 3 months after vaccination with FluLaval, on an unspecified date on or after 24 October 2006 and before 16 February 2007, the subject experienced a sore right arm and was unable to lift the right arm. The subject was seen at a physician's office. The pharmacist considered the events were disabling. the outcome of the events was not reported.				Y				Y	U	10/24/2006			UNK	OTH	OTH		UNK	The subject's medical history, concurrent conditions, and concurrent medications were not reported.		A0639812A	1						1	Injected limb mobility decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F600911~UNK~~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Disabling	Influenza
0272551	02/19/2007	TX	1.08	1	.0	F	02/19/2007	was diagnosed with chicken pox a month after getting Proquad				Y					Y	01/02/2007	02/08/2007	37		PVT	PVT						1						1	Varicella	FLU3~SANOFI PASTEUR~U2200KA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0975F~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~1308670h~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0272568	02/19/2007	CT	83.0	82		F	02/19/2007	Pt was vaccinated on right arm for pneumovax (Mecrk) and left arm for FLUARIX on 10/25/06. She presented to clinic on 1/4/07 c/o right shoulder pain that she claimed to have persisted since date of immunization. She subsequently followed up with her physician for imaging/xrays. She is now attending physical therapy for the arm as ordered by her physician, she reports.				Y					U	10/25/2006	01/04/2007	71	Pt reports she had x-rays via her private physician.	UNK	UNK	Aspirin	NONE REPORTED BY PT	UNKNOWN			1						1	Musculoskeletal pain; Physiotherapy; X-ray	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~00000~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0272569	02/19/2007	NH	13.0	13		F	02/19/2007	pt recieved HPV #1 on 1/25/07 since vaccine has had period for past 22 days. has not had issues with vaginal bleeding between period before vaccine.									U	01/25/2007	01/27/2007	2	will be getting tsh, ferritin, and cbc	PVT	PUB						1						1	Vaginal haemorrhage	FLUN3~MEDIMMUNE VACCINES, INC.~500438p~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0960f~UNK~IM~LA~HPV (GARDASIL)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~RA~TDAP (BOOSTRIX)~1	USA		Influenza
0272735	02/20/2007	GA	2.0	2	.2	M	01/24/2007	Fluvirin was administered instead of Fluzone-off label use of vaccine by accident.  Clinic contacted manufacturer and Imm. program consultant, who talked with NIP.  Dose will count as 1st dose.  Fluzone to be given in 4 wks.  Talked with mother 1/24/07 and explained about vaccine. She stated that child is doing fine-just a little fussy; no fever.  Will return to clinic 02/20/07 for Fluzone.										01/23/2007				PUB	PUB		NONE	NONE		GA07003	1						1	Irritability; Wrong drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71032~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0272738	02/20/2007	NE		4		M	02/09/2007	Pt has red area 15cm x 9cm				Y						02/08/2007			NONE	PUB	UNK		NONE				1						1	Erythema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~SANOFI PASTEUR~~UNK~~~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0272746	02/20/2007	UT	42.0	42		F	01/30/2007	Our client received vaccines January 16, 2007. On January 22 she noticed a rash on her stomach, which moved on her back and up into her armpits. It was still moving when she called on January 25th. She had no hives, no fever, no chills. I spoke with the PA-C, who said it sounded like a histamine reaction and we advised her to try an antihistamine or see a doctor or go to the emergency room, if it concerned her. Also, she and another person, who received vaccines at our clinic the same day, both had a tooth that had become sensitive. We advised her to see a dentist.										01/16/2007	01/22/2007	6		PUB	PVT	Cymbalta		Allergic PCN, HC irreg heart rhythm and fainting.			1						1	Rash; Sensitivity of teeth	FLU3~SANOFI PASTEUR~U2281AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB260AA~1~~RA~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHABV107AC~1~~LA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~Y10512~UNK~~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1027F~UNK~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TDAP~SANOFI PASTEUR~C2631AA~1~~LA~TDAP (ADACEL)~1	USA		Influenza
0272766	02/20/2007	MI	1.04	1	.0	F	02/20/2007	Induration of L thigh in area of injections.  Much worse than the normal reaction, with associated erythema and duskiness.									Y	01/19/2007	01/28/2007	9		UNK	UNK			Failure to thrive, small for gestational age, unusual facial features			1						1	Erythema; Injection site induration	FLU3~SANOFI PASTEUR~42307AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0281F~3~IM~RL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0094F~1~SC~LL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|PNC~PFIZER\WYETH~B08691E~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1143I~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0272769	02/20/2007	SC	43.0	43		F	02/20/2007	@/14/07:   Given IM injection on 12/6/06 in right deltoid.  States injection site still very sore and complaint of pain in right shoulder and upper arm when doing exercises or at rest.  Has not taken any OTC meds or used moist heat to arm - may have taken Advil immediately after vaccination.									N	12/06/2006	12/07/2006	1	NONE	PUB	PUB	Levothyroid; Fosamax; Multi-vitamin; and calcium	NONE	Hypothyroidism and osteopenia		SC0632	1						1	Injection site pain; Musculoskeletal pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA240BA~6~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0272770	02/20/2007	WI	47.0	47		F	02/20/2007	Patient calls on tuesday am as our office was closed on monday.  She states she was in the emergency room over the weekend.  After receiving the flu shot on friday she had roughness in her throat, difficulty breathing, dizziness and was sick to her stomach.  She was told in the er that she should not receivet the flu shot again.  She was prescribed generic benadryl, famotine 20mg, and prednisone 20 mg.  She did not have any symptoms in the area the injection was given which was the Right Deltoid.  Client does not recall when I spoke with her after the event if she had ever had the flu shot in the past, she thinks that she had not ever had one.				Y					Y	02/16/2007	02/16/2007	0		UNK	UNK	not known was put on the 3 meds listed above at time of incident					1						1	Abdominal pain upper; Dyspnoea; Throat irritation	FLU3~SANOFI PASTEUR~U2283Aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0272777	02/20/2007	WI	51.0	51		U	02/20/2007	usual flu vaccine on 2/12/07, the night of injection got severe pain, swelling in arm, but no fever, SOB, hives or other reaction				Y					U	02/12/2007	02/12/2007	0	na	PVT	PVT		o  DJD (DEGENERATIVE JOINT DISEASE)     o  KNEE PAIN         failed TKR   o  HTN (HYPERTENSION)     o  ASTHMA	none			1						1	Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~u2282aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0272783	02/20/2007	DE		1	.0	M	02/20/2007	Right thigh swollen and firm mass to palpation.									Y	02/16/2007	02/17/2007	1	NONE	PVT	PUB						1						1	Injection site induration; Injection site swelling	FLU3~SANOFI PASTEUR~U2220FA~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~AHAVB106BA~1~~LL~HEP A (VAQTA)~1|HIBV~MERCK & CO. INC.~1274F~3~~LL~HIB (PEDVAXHIB)~1|MMRV~MERCK & CO. INC.~1332F~1~~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0272795	02/21/2007	NY	4.0	4		M	02/21/2007	This case was reported by a physician and described the occurrence of increased liver enzymes in a 4-year-old male subject who was vaccinated with Havrix for prophylaxis. Concurrent vaccination included influenza virus vaccine given on 27 January 2007. Concurrent medications included Amoxicillin trihydrate and Dimetapp-DM. On 27 January 2007 the subject received 1st dose of Havrix at 720 elisa units. At an unspecified time after vaccination with Havrix, the subject experienced increased liver enzymes and lethargy. This case was assessed as medically serious. At the time of reporting the outcome of the events were was unspecified. The physician considered the events were possibility related to vaccination with Havrix.									U	01/27/2007			UNK	OTH	PUB	Amoxicillin trihydrate, Dimetapp-DM, (Bromepheniramine maleate + Dextromethorphan HBr + Phenylpropranolamine HCl + Phenylephrine HCl)	UNK	No relevant medical history was reported.		A0639901A	1						1	Hepatic enzyme increased; Lethargy	FLU3~SANOFI PASTEUR~U224AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHVB129AA~1~~RA~HEP A (HAVRIX)~1	USA		Influenza
0272817	02/21/2007	AZ	4.0	4		F	02/06/2007	Urticarial rash developed immediately at the site of DTaP and IPV injections.									Y	02/06/2007	02/06/2007	0		PVT	PVT		NONE	NONE			1						1	Injection site rash; Urticaria	DTAP~SANOFI PASTEUR~V1985AB~5~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~V2281AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1031~4~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~1531F~2~SC~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0272848	02/21/2007	CO	14.0	14		M	02/20/2007	1-2 minutes after vaccine patient felt dizzy than blacked out. Lasted 1-2 minutes. No other SX at this time.									Y	02/16/2007	02/16/2007	0		OTH	PVT	NONE	Runny Nose X 2D	NONE			1						1	Dizziness; Loss of consciousness	FLUN3~MEDIMMUNE VACCINES, INC.~500440P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U1874AA~1~IM~LL~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B011CA~UNK~IM~RL~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~0908F~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0272850	02/21/2007	OH	19.0	18		F	02/21/2007	Patient received influenza vaccine on 10-13-06 from unknown site. Approximately 2 days later she developed diarrhea and body aches, these symptoms progressed to respiratory distress and decreased oxygenation and she was subsequently admitted to Hospital on 10-18-06. The patient has suffered similar reactions to vaccines in the past. 3/16/07 Received medical records from hospital which reveal patient experienced difficulty breathing, SOB, fever, cough, malaise/fatigue, diarrhea & wheezing.  Developed diarrhea & myalgia 2 days s/p flu vax w/increased SOB & productive cough on day of admit.  Sats in ER were 40s w/copious secretions.  Admitted on 10/18 & tx w/IV antibiotics, nebs, CPAP & progressed well.  D/C to home on 10/20 on oral antibiotics, nebs & nightime BIPAP. FINAL DX: pneumonia & respiratory distress.				Y	Y	2			Y	10/13/2006	10/15/2006	2	N/A LABS: CXR stable w/airspace disease & volume loss RLL.  RVAP neg.	UNK	UNK		Was hospitalized with pneumonia approximately one month prior to adverse reaction but chest x-ray was improved.	SMA type II, scoliosis, G-tube feeds, uses bi-pap at home at night. No known drug allergies PMH: pneumonia 1 mo prior to admit. SMA-2 (spinal musculature atrophy type 2). Asthma.			1						1	Diarrhoea; Oxygen saturation decreased; Pain; Respiratory distress; Similar reaction on previous exposure to drug	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0272851	02/21/2007	KS	8.0	7		F	02/21/2007	The HPV vaccine was given to a 7 yr. old girl.									Y	02/21/2007				UNK	UNK	NONE	NONE	NONE			1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U2272AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1208f~2~IM~LA~HPV (GARDASIL)~1|VARCEL~MERCK & CO. INC.~1301F~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0272852	02/21/2007	CT	78.0	78		F	02/21/2007	Stated that injection felt different.  No immediate pain, burning, numbness, tingling, tenderness or other symptoms upon or immediately after injection.  No symptoms experienced until at least ? 2 days later.  The arm bothers her in the left deltoid area (very localized)upon raising.  No pain upon rest or with some types of movement - only with certain types of movement.  Had rotator cuff problem in right arm and it may feel something like that but no awareness of injury to left arm.  Is unable to characterize the pain.  Did not report or seek treatment from her private physician because it costs too much money.  She stated that she did not try to self-treat with heat, cold or medication.  She states it has gradually improved but was concerned because of the length  of time since receiving.  She may mention to her PMD during her routine checkup in May 2007.									Y	10/31/2006	11/02/2006	2	NA	PUB	PVT	Thyroid repacement therapy for years	NA	Basically healthy except for thyroid problem	NA~ ()~NULL~~In Patient		1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2244AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0272860	02/21/2007	FL	32.0	32		M	02/21/2007	pt complained of headache, body ache,sore throat, cough. Pt given deconamine,tessalon,and tylenol. Seen by Physician 2/7/07.Pt states immunizations record was falsefied to cover double flu vaccination. documentation show Hep B was given. Pt states he did not receive Hep B. He states he was given a yellow sticky note and sent to Technician for shot. On the note he says it stated Thyphoid and Flu. He stated when he tried to tell the tech that he had receive the flu already he was told that he was gonna have to get what was on the sticky. The pt wasn't given record of vaccination, due to the fact the nurse felt AFCITA verification would slow the process. Vaccine documentation was input at the end of the day.				Y					Y	02/03/2007	02/04/2007	1		MIL	PVT	None	NONE	none			1						1	Cough; Headache; Pain; Pharyngolaryngeal pain; Wrong drug administered	FLUX~UNKNOWN MANUFACTURER~~2~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB367AA~2~IM~UN~HEP B (ENGERIX-B)~1|TYP~SANOFI PASTEUR~z0122~2~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0272871	02/21/2007	MI	1.05	1	.1	F	02/21/2007	Maculopapular erythematous lesions over neck, retro auricular torso, groin and extremities, no adenopathy.				Y					Y	02/14/2007	02/20/2007	6		PVT	PVT						1						1	Rash erythematous; Rash maculo-papular	DTAP~SANOFI PASTEUR~U1965BA~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2273AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE779AA~4~IM~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0972R~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08684F~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1048F~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0272877	02/22/2007		52.0			M	02/02/2007	rash											10/25/2006		rash	UNK	UNK						1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0272878	02/22/2007	NY	4.0	4		M	02/19/2007	Developed hives on left lower arm (same arm as shot given in), developed a cherry red mark on left and right jaw line and red dots on upper cheek bones-both left cheek and right cheek-mom gave Benadryl for treatment.										02/16/2007	02/16/2007	0	NONE	PVT	PVT	Polyviflor, Albuterol	NONE	NONE			1						1	Erythema; Urticaria	FLU3~SANOFI PASTEUR~U2204AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0272890	02/22/2007	MN	1.0	1	.0	F	02/22/2007	Started with fever night shots were given (2/16) Hard swollen lump that was very hot was noticed 5 days after getting shotshib/heb/mmr/chicken pox & flu.  Dr did say it was either the MMR or the Flu shot that is the cause.  Dr said was more than likely an infection caused by the shot and she is now on an antibotic for 10 days.  Hopefully it clears up.  very painful.				Y					U	02/16/2007	02/16/2007	0	none	PVT	UNK	none	none	slow weight gain from 6months-12months.  18lb 4 oz at time of shots 2/16/07			1						1	Pain; Pyrexia; Skin nodule; Skin warm; Swelling	FLUX~UNKNOWN MANUFACTURER~~2~~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~1~~LL~HEP A (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~4~~LL~HIB (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~2~~RL~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~1~~RL~VARICELLA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0272891	02/22/2007	OH	1.08	1	.1	M	02/22/2007	Parents both present for immunizations for child on 2/20/07. Spanish speaking only, with young girl along to translate. She states Pablo received his second flu shot on 12/12/06 and was admitted the next day to the hospital with a very high fever. He has had no previous reactions with any of his other immunizations, including the 1st flu shot on 11/14/06. 03/01/07-records received from facility for DOS ER visit 12/12/06 day of vaccine, Temp 102.3. ER visit  12/13/06 Febrile seizure, bilateral otitis media. ER visit 12/14/06 DX febrile illness bilateral otitis media.				Y					Y	12/12/2006	12/13/2006	1	Unknown..very difficult to work with young translator.. she stated the baby had a fever of 110..very high!. Recovered with no problems. Labs received 03/01/06 blood culture no growth, CBC WNL except for lymphocyte 48 and monocyte 17, glucose 108, BUN 21, sodium 133. CXR: normal chest. WBC 2.3 stabs 6, urine culture negative	UNK	UNK		none	none			1						1	Pyrexia	FLU3~SANOFI PASTEUR~PU2261AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0272894	02/22/2007	VA	33.0	32		F	02/22/2007	Took flumist for the first time in october6, 2005. I have been having multiple joint aches, pains that I did not have prior to this vaccine. After months of speaking with the vaccine supervior, she recommended that I enter this report and not take the flumist again.									N	10/06/2005			C-spine series, MRI, bone scan	MIL	MIL	celexa, motrin, birth control pills	no	none			1						1	Arthralgia; Bone scan; Nuclear magnetic resonance imaging; Pain; Spinal X-ray	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0272914	02/22/2007	WY	1.5	1	.5	M	02/20/2007	2/19/07 fever of 104 degree after 2 hours of vaccine administration. Pt won't walk due to pain in thighs.  2/20/07 doctor prescribed Tylenol with Codeine, Motrin and Benadryl				Y					U	02/19/2007	02/19/2007	0		PVT	PUB	Tylenol	NONE	NONE			1						1	Abasia; Pain in extremity; Pyrexia	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B033AA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2191KSA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1014F~3~IM~RL~HIB (PEDVAXHIB)~1	USA	Emergency room visit	Influenza
0272926	02/23/2007	OH	40.0	40		F	02/23/2007	Pt administered Fluarix brand flu vaccine in the right deltoid area on 1/29/07. Three days later she said that the area became reddened and hard all around it for 5 days. She also stated that she had taken the flu vaccine annually for 10 years (unknown brand) and has had no problems except for the first year when she was sick for one month after taking the vaccine.									Y	01/29/2007	02/01/2007	3	None	MIL	PVT	Crestor, Vicodin, lorazepam, omeprazole, capsaicin, nortriptyline, trazodone	None	nonsteroidal antiinflammatories (Naprosyn, oxaprozin)			1						1	Injection site erythema; Injection site induration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA244AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0272953	02/23/2007	CO	55.0	55		M	02/20/2007	Initial report received on 09 February 2007 from a consumer, who is the patient. A 55 year old male received on 25 September 2004 Fluzone (lot number not reported) (side, site and side of administration were not reported) and within 15 minutes developed nausea and weakness that progressed to the right side of the face, right side of the neck and right upper extremity with numbness tingling and pain, which continue to present. Patient was able to retain mobility but was loosing strength. It was unknown if the patient was hospitalized. The patient was diagnosed with MS (multiple sclerosis) by a neurologist and did not recover. The patient was allergic to penicillin. CT scans and Spinal Tap were done. Results were not provided. The patient refused to provided all requested information.				Y					N	09/25/2004				OTH	OTH			Allergic to penicillin		200700416	1						1	Asthenia; Hypoaesthesia; Multiple sclerosis; Nausea; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0272954	02/23/2007	MN	8.0			U	02/20/2007	Initial report received on 14 February 2007 from a health care provider who has acquired the information from a newspaper article. Per the newspaper article, it has been reported by the state department of health that an eight year old child, who had received a flu vaccination and had unspecified underlying health problems, died from the disease influenza on 12 February 2007. Additional information was not provided related to this case. (The firefighter that was also reported in the title of the article had not been vaccinated.	Y	02/12/2007							N		02/12/2007			UNK	UNK			The patient had unspecified underlying health problems.		200700441	1						1	Death; Influenza; Vaccination failure	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0272972	02/23/2007	PA	43.0	43		F	02/23/2007	Pt received pneumovax in right deltoid, by next day arm was sore, swollen and red.  Pt instructed to ice site and take Tylenol/Motrin, site worsened and pt bought into office 2/23/07 2:20 for an appt with dr.				Y					Y	02/21/2007	02/23/2007	2		PVT	PVT		new onset diabetes	elevated blood pressure and cholesterol, goiter			1						1	Erythema; Oedema peripheral; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~Aflua234au~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0272979	02/23/2007	WI	1.22	1	.2	M	02/15/2007	Red, rash, blotchy on legs (both) and abdomen. Itchy? Resolved in 48 hours completely. Mother gave cool bath, ibuprofen.									Y	02/14/2007	02/14/2007	0		PUB	PUB						1						1	Erythema; Rash macular	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B027AA~2~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2220AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB130AA~1~IM~RL~HEP A (HAVRIX)~1|HIBV~MERCK & CO. INC.~0084F~3~IM~RL~HIB (PEDVAXHIB)~1	USA		Influenza
0272980	02/23/2007	MD	1.5	1	.5	M	02/20/2007	Began with fever, irritability one hour after vaccine administered. Temperature 102 a.m., pulse rate 160. No SOB, wheezing or cough.				Y					Y	02/12/2007	02/12/2007	0	NONE	PVT	PVT	NONE	NONE				1						1	Body temperature increased; Irritability; Pyrexia; Tachycardia	FLU3~SANOFI PASTEUR~U2660AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0272981	02/23/2007	GA	81.0	81		F	02/13/2007	Approximate 6 cm blistered, hard to touch area, red. Approximately 15-17 cm area around, red, puffy and hot to touch. Itching. Skin appears slightly scaly in this area. Treated with Benadryl PO - Cefazolin (IV) x doses the PO Keflex x 7 days.										02/08/2007	02/12/2007	4		PVT	PVT	Diltiazem, docusate, Lorazepam, Furosemide, Vicodin, Singular, Reglan, Desyrel	Atrial fibrillation	NKA			1						1	Blister; Erythema; Pruritus; Skin exfoliation; Skin warm; Swelling	FLU3~SANOFI PASTEUR~U2204AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1175F~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0272982	02/23/2007	PA	1.51	1	.5	M	02/09/2007	Developed a rash on face and trunk also a temperature of 102.00 for a day. Rash went away 3 days later. No treatment was necessary.									Y	01/17/2007			NONE	PUB	OTH	NONE	NONE	NONE			1						1	Body temperature increased; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1	USA		Influenza
0272985	02/23/2007	KS	49.0	49		M	02/08/2007	Pt received a TD and Flu shot on 10/25/06. According to pt, he did not plan on getting the flu shot, but was encouraged to get it. About 4 days later his throat was itching and he could feel phlegm coming on.  He states he could hear it on forced expiration. In a week the phlegm was yellow for 2 weeks to a month.  After a round of antibiotics he would feel the symptoms leaving, but they would return immediately that evening. He states he is still taking antibiotics, is on Levaquin 500mg to dry up the chest and has taken 3-7 day courses of this. States he can not get a good breath and becomes short of breath with very little activity. He loses his voice quickly and needs his voice on his job.  States he sweats or freezes, but really does not feel sick the way he thinks he should with the flu. He has a history of Hep C diagnosed 5 years ago and has not had problems with this recently.				Y					N	10/25/2006	10/29/2006	4		PUB	UNK		Hep C (no problems)				1						1	Aphonia; Dyspnoea; Feeling cold; Hyperhidrosis; Increased upper airway secretion; Throat irritation	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69899~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~SANOFI PASTEUR~U1724DA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0272987	02/23/2007	AL	1.57	1	.6	M	02/22/2007	Patient received MMR 6 days prior. Presented with angioneurotic edema and erythema multiforme rash, fever, arthralgia and joint swelling 3/26/07Received medical records from hospital which reveal patient experienced fever, rash & swelling including angioedema of lips.  Tx w/IV steroids, IVF, IV antibiotics, Benadryl & Atarax. Admitted to hospital from 2/21/07-2/24/07.  Edema improved but continued to have fever/chills up until 24 hrs prior to d/c.  Home on continued oral steroids FINAL DX: Erythema multiforme.				Y	Y	3				02/15/2007	02/21/2007	6	LABS: WNL.  Cultures neg.	MIL	MIL			NONE			1						1	Angioneurotic oedema; Arthralgia; Erythema multiforme; Joint swelling; Pyrexia	DTAP~SMITHKLINE BEECHAM~AC14B40CA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~V2174GA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0701E~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Hospitalisation	Influenza
0272934	02/26/2007	LA	39.0	39		M	02/25/2007	Constant pain in the neck, diagnosed as arthritic after MRI in 2004 showed nothing related to trauma, treatment still ongoing, as traction only temporarily relieves pain, issued a cervical device to provide self administered traction for use during periods of no health care coverage. Prescribed Celebrex to lessen the pain, however due to inadequate medical care, after release from active duty, could not afford to continue regimen. Inability to focus on tasks within a few days of the initial series, and spouse noticed almost immediately a marked loss of short term memory continuing to the present.  No treatment.				Y				Y	N	02/14/2003	02/15/2003	1	MRI	MIL	MIL						1						1	Amnesia; Arthralgia; Neck pain; Nuclear magnetic resonance imaging; Vision blurred	ANTH~EMERGENT BIOSOLUTIONS~FAV064~UNK~SC~RA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~RA~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~RA~HEP A (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~UNK~~LA~MENINGOCOCCAL (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~~RA~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1|TYP~SANOFI PASTEUR~~UNK~~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Disabling	Influenza
0273015	02/26/2007	AZ	4.0	4		M	02/26/2007	Few hours after receiving vaccines listed below, child's left upper arm became painful, red, and swollen.  Mother reports that child felt warm.  SHe gave him ibuprofen x ! yesterday.  Today (2pm) child's upper left arm is swollen, warm to touch, red (shoulder to elbow). T-100.2 No enlarged lymph nodes, Less painful today.									Y	12/21/2006	12/21/2006	0	N/A	PUB	PUB	No	None	None		AZ0701	1						1	Body temperature increased; Erythema; Oedema peripheral; Pain in extremity; Skin warm	DTAP~SANOFI PASTEUR~1965ca~5~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2286AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1030-2~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~0971F~2~SC~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0273049	02/26/2007	MI	59.0	58		F	02/22/2007	Symptoms began 24 days after flu vaccine given on 1/4/07.  02/27/2007 VAERS report received with medical records included. Patient initially presented to local ER with symptoms of diffuse generalized weakness beginning 26 days after receiving flu shot.  She was initially discharged from the ER but presented again the next day with worsening symptoms. 2 days prior to admission she noted tingling in her arm.  1 day prior she was unable to lift her arms above the shoulders. On the day of admission she noticed leg weakness and was unable to get up.  She was admitted. Initial PE showed Power in upper and lower extremities is 3 by 5.  Reflexes symetrically absent in all 4 limbs.  Touch greatly diminished. O2 Sat 94%. Somewhat depressed, otherwise WNL. Multiple consults.  Treated with hematoglobin with slight improvement initially, however still continued to have weakness and difficulty raising arms. Patient was transfered to another facility for continued treatment. Final Diagnosis:  1) Acute Guillain [[name]] Syndrome with diffuse weakness. 2) Dysphagia.  3) Worsening acute renal failure.  4) Hypoxia.  5) Degenerative Joint Disease 6) Increased Creatinine  7) Diabetes Mellitus Type II  8) Hypercholesteremia  9) Urinary Incontinence  10) Peripheral Neuropathy  11) Increased WBC  12)  Respiratory Alkalosis. Initial Admitting DX to 2nd hospital is: Probable Guillain [[name]] Syndrome.  Nuerology consult Impression:  Differential DX certainly includes acute inflammatory demyelinating polyradiculopathy, superimposed upon a baseline diabetic neuropathy.  Indeed the presence of Guillain [[name]] Syndrome can be difficult to make in the presence of baseline diabetic neuropathy as well as AIDP.  Primary myopathic process is included in the differential DX given her proximal weakness.  Dysfunction at the level of the neuromuscular junction is less likely. Rheumatology consult Impression: is consistant with polymyositis. 02/28/2007 Discharge Summary requested from 2nd hospitalization./pc 03/02/2007 D/C Summary received from above 2nd hospitalization.  Physical exam unchanged compared to admission, except pt. seems to have better strength in her legs and even in her arms.  She is now able to walk.  Patient was D/C'd to an inpatient rehab. D/C DX:  GBS vs. Myopathy.			Y	Y	Y	14	Y		Y	01/04/2007	01/30/2007	26	See hospital notes/labs. Significant Labs and Diagnostics:  include a rise in Creatinine from 1.3 to 2.4 during admission. Spinal tap was culture (-), WBCs 3 and protein 60.  UC (-). ANA (-) Thyroid studies (-). Acetylcholine receptor antibodies (-). CT Brain shows no evidence for acute intracranial process at this time. CXR shows no acute process or interval change.Barium Swallow shows minimal aspiration. No EMG was done (at 1st facility). Labs and Diagnostics from 2nd facility: EMG showed demyelinating polyneuropathy, but it was difficult to interpret because pt. also has some degree of chronic diabetic polyneuropathy.  ANA now mildly (+), SSA (+), Muscle biopsy was consistant with myopathy.  Polymyositis cannot be ruled out.	PVT	OTH	See list. Meds: Insulin-Lantus, Bactrim, Aceon, Lortab, Insulin-Humalog, Duragesic patch, Lasix, Vytorin.	NONE	Breast cancer, DM, neuropathy, Hyperlipidemia, PVD.  PMH: Breast Cancer, Degenerative Joint Disease, Diabetes, Increased cholesterol, osteoarthritis, urinary incontinence, peripheral neuropathy.  Recent URI.  Recent UTI.  Allergies: none.			1						1		FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0273056	02/26/2007	OH	69.0	69		F	02/20/2007	11/5/06 emergency room pain in L arm in area where shot administered, 11-9-06 Dr orthopedic doctor Roto cuff impingement?, 11-13-06 started physical therapy  constant pain intense pain, 12-27-06 DR steroid pills, 1-11-07 Dr shoulder injection cortisone, 1-17-07 Dr nerve test on arm and shoulder, 1-23-07 DR, 1-26-07 hospital started physical therapy again still taking it, 1-8-07 MRI at hospital.				Y					N	10/25/2006	10/28/2006	3		UNK	UNK	Valium	NONE	NONE			1						1	Injection site pain; Rotator cuff syndrome	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA204BA~1~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0273058	02/26/2007	MN	6.0	6		F	02/21/2007	Patient had received a 025 ml dose of Fluzone IM on 2/09/07. Should have received 05 ml. Phone cell to dept of health advised repeat dose of .5 ml which was given on 2/20/07. Mother called 2/21/07 to report a lacey like rash developed about 7pm on arms, legs, buttock and noticed it on abdomen and back am 2/21/07. Child has a low grade fever, rash not raised, no other SX recommended Benadryl and Tylenol for age.									U	02/20/2007	02/20/2007	0		PVT	PVT			NKA			1						1	Pyrexia; Rash	FLU3~SANOFI PASTEUR~U2212AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0273059	02/26/2007	DE	53.0	53		F	02/09/2007	B lower extremity red dots that formed into palpable petechiae, also on extensor surfaces B UES.									Y	01/08/2007	01/09/2007	1	ESR-WNL, CBC-WNL	PUB	PUB	Naprosyn, Premarin, Benadryl, Atenolol, Prednisone.		Arthritis, Chronic sinusitis, HTN			1						1	Erythema; Full blood count normal; Petechiae; Red blood cell sedimentation rate normal	FLU3~SANOFI PASTEUR~V21877AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0273063	02/26/2007	UT	66.0	62		U		Pt received a flu shot at the flu clinic on Oct 4 2006. He received his flu vaccine from the biojector. Called in Dec complaining that his arm was still sore to his wrist.										10/04/2006	10/04/2006	0		PUB	PUB		NONE	He stated that he was well at the time of vaccination.			1						1	Pain in extremity	FLUX~UNKNOWN MANUFACTURER~1870~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0273065	02/26/2007	ND	14.0	14		F	02/22/2007	2 days after receiving vaccines started having sharp, stabbing pain, and bruising in cervix area. Muscles ache and burn also inner thighs. No fever, no vaginal discharge. Still having discomfort 12 days afterwards. No sexually active.									Y	02/08/2007	02/10/2007	2		PVT	PVT		NONE	Depression, low back pain			1						1	Cervix disorder; Contusion; Discomfort; Myalgia; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72004~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~MERCK & CO. INC.~1282F~1~IM~RA~HEP A (VAQTA)~1|HPV4~MERCK & CO. INC.~0955F~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U1822AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0273069	02/26/2007	MA	1.25	1	.3	M	02/15/2007	right thigh adjacent to injection site with 10 cm x 5 cm red, warm, indurated area, noticed this am by mom, vaccines yesterday, no fever, no pain									Y	02/14/2007	02/15/2007	1		PVT	PUB		NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site warmth	DTAPH~SANOFI PASTEUR~U1813AB~UNK~IM~RL~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~U2201EA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0273101	02/27/2007	AZ	78.0	78		F	02/15/2007	Mid morning, 9 October 2006, I entered food market to make a few purchases. Just inside the front door was set up a table with personnel who were administering flu shots. After completing the necessary paper work and procedures, I requested the flu shot be given me in my left arm, for which I was refused, being the serum would dispense faster if injected in right arm, since I am right handed. The injection was put into my right deltoid. I asked the person who did the injection to provide me with her name. She did (to the best of my recollection). I asked her last name and she did not wish to give it to me, stating, just RW. I felt very little at the time of the injection, so, made my purchases and returned home to finish packing my suitcase, since I was leaving the morning of 11 October 2006, to attend a 4-day event out of the country. During the early morning hours of 11 October, my right upper extremity began being very painful and my right hand began swelling. By the time i arrived at my destination, my hand was SO swollen and the whole extremity, from shoulder to finger tips, was so very painful, I could not use it, had to have assistance with personal care and ADL's. I tried to treat the condition my self by applying ice/hot packs/epsom salts soaks, took Benadryl and procured a sling to immobilize the extremity. Nothing I tried gave any relief and th extreme swelling did not diminish. Consequently, I decided to go to the local medical facility emergency room. Since I returned home, I have been seen by at least 7 doctors and physical therapists at clinic and microsurgery is scheduled to be done on my right hand on 27 March 2007. I continue to have constant pain in my right deltoid (approximately a 5 on a scale of 1 to 10) and I feel neuro involvement in right breast. I have next to no use of my right thumb and my hand goes numb during the night the right thumb and fingers are stiff and feel as though the digits are on fire. Of course, this awakens me and disrupts my sleep and rest. At this point, the restoration of normal function to my RUE seems bleak. Prior to the flu shot, I was a normal, active, happy human being. Other than having the microsurgery on the right hand, it appears I have no other options than to live with a partially dysfunctional RUE which occurred as a result of having had a flu shot.  02/28/2007 VAERS report received with medical records attached. No additional records needed. Discharge Summary of 10/16/2007 revealed an ER admission for c/o swelling of the right wrist, distal forearm, and dorsum of her right hand.  Pt. c/o that the swelling and pain began several days after her flu shot.    Temp was 100.5. She was admitted for 1 night for IV antibiotics.  Swelling and pain reduced and she was D/C to home on PO antibiotics. Discharge DX:  Cellulitis right wrist and right forearm, improved. F/U visit from PCP on 12/18 where pt. reports continued neuropathic pain  in the hand and wrist at times.  Arm remains sore with additional c/o weakness in that arm. Likely reaction to influenza vaccine.  1/4/10 Pain at injection site-have been seen and evaluated by many doctors for this at clinic, referred surgery of hand. Follow-up: Weakness in Rt thumb - pain rt deltoid at injection site. Several attempts made to report to Health Dept., but was given different numbers to call- eventually was instructed to notify CDC and local Examiners - which I did. Subsequently, I received correspondence from a board member with a Ph. # to contact. I didso, and received a voice mail. I left my call back Number. That was in Feb. 07 No return call as yet. 4/27/07. I am still seeing doctors at clinic for this.				Y	Y	1		Y	N	10/09/2006	10/10/2006	1	Was seen in emergency room and subsequently admitted. Labs and Diagnostics:  Wrist X-ray showed no acute changes.  WBCs 10,000 with a left shift. Sed rate elevated at 37.  Uric acid low normal. Inflammation - Increased Sed Rate	OTH	PUB		NONE whatsoever	PMH:  Osteoporosis, arthragias and degenerative arthritis, colon polyps, abnormal, epistaxis. NKDA			1						1	Breast disorder female; Burning sensation; Hypoaesthesia; Hypokinesia; Injection site pain; Joint stiffness; Oedema peripheral; Pain; Pain in extremity; Sleep disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA204BA~UNK~IJ~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation,Disabling	Influenza
0273102	02/27/2007	IL	44.0	44		M	02/27/2007	Neuropathy, chills, pain, sweating under the care of an internal MD. Doctor referred to a neurologist and rheumatologist also went to chiropractor and acupuncturist				Y						11/01/2006	12/01/2006	30	AS requested by DR	OTH	OTH		NONE	Hypertension, COPD, RA			1						1	Chills; Hyperhidrosis; Neuropathy; Pain	FLUX~UNKNOWN MANUFACTURER~~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0273113	02/27/2007	CA	1.08	1	.1	F	02/22/2007	Hive started 5 days after vaccines inner thigh / outer thighs, stomach, chest and both upper arms.				Y					U	02/15/2007	02/20/2007	5	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~UT2191JA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1213F~1~~RL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~1483F~1~~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0273116	02/27/2007	MD	26.0	26		F	02/22/2007	symptoms started 2-20-07 at 7pm.  1st noticed bumps on arms. She now has hives on her abdomen, face, neck and arms.  She also felt faint at times.									U	02/20/2007	02/20/2007	0		PVT	UNK	Metronidazole 100 mg/day					1						1	Dizziness; Rash; Urticaria	FLU3~SANOFI PASTEUR~u2168CA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0011u~1~IM~RA~HPV (GARDASIL)~1	USA		Influenza
0273118	02/27/2007	IN	9.0	8		F	02/15/2007	1-2 days after Flu Mist administered by her school (#2) child had rash-pain behind left ear followed by drooping left site lip-eye partial closure. 02/28/07-records received from PCP for DOS 2/15 and 2/19/07. DX Bell's Palsy. C/O onset 5 days ago, rash on body,pain behind left ear, PE:face droops left of of left eye, left eyelid unable to close completely unable to wrinkle forehead. Return visit on 2/19/07 eye partial closure of left eyelid. mouth droops.				Y					U	02/09/2007	02/10/2007	1	left Bell's palsy	UNK	UNK						1						1	Facial palsy; Pain; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500440P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0273119	02/27/2007	MA	53.0	83		M	01/12/2007	Pt was given a flu shot at a clinical on 11-16-06. The nurse who gave the shot said it didn't feel right and questioned if the had given the shot with a syringe she had used on the previous patient.  Pt was sent to hospital emergency department for evaluation and testing.				Y					Y	11/16/2006	11/16/2006	0	total bilirubin, ALT, HIV, Hep C, Hep B surface-Ag, Retroviral serology	PUB	PUB	Diovan, Amitriptyline, Doxazosin, Plavix, Fosamax, Trusopt, Alphagan eye drops	no acute illness	Diabetes, Hypertension, Vascular disease, Interstitial disease		MA0705	1						1	Alanine aminotransferase; HIV test; Hepatitis B surface antigen; Virus serology test; Wrong technique in drug usage process	FLU3~SANOFI PASTEUR~U2279AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0273122	02/27/2007	UT	39.0	39		F	02/13/2007	Vaccine administered at 1500. At 1650 pt c/o extreme itching and SOB. AT 1705 pt reports increase in itching, and swelling around eyes. Eyes red and puffy. Eppy 1:100 0.5ml SQ. Albuterol sun, Benadryl 50 mg IV, Solumedrol 125 mg x 4 doses given.  03/06/2007 MR received from o/n hospital stay for c/o chest pain and dyspnea following her flu shot.  Pt. also experienced circumoral paresthesias, and numbness down her left arm 2' to hyperventilation, as she became increasingly panicked.  Pt. was given 4 baby ASA, and SL nitroglycerine en route to hospital as well as O2 vai NC. PE: Urticaria noted on face and abdomen. (+) periorbital swelling. Pt anxious, otherwise WNL. Assessment: Chest pain appears to be chest wall tenderness, dyspnea and hyperventilation, and acute allergic reation probably to flu vaccine. Fianl DX:  Acute allergic reaction likely to flu serum.							Y		Y	02/02/2007	02/02/2007	0	Allergic to Sudafed, denies allergy to eggs.   Labs and Diagnostics:  Cardiac enzymes were (-). CMP showed a glucose of 142 (on steroids). BUN 5. Otherwise unremarkable.  CBC unremarkable. CXR normal. D-dimer (-).  EKG: NSR with possible anterior infarct.	PUB	UNK	Meds:  Cyclobenzaprine and Lortab.	Chest Pain	Degenerative joint disease, hypothyrodisim, asthma, seasonal allergies, obesity, dysmenorrhoea, depression, insulin resistance, chronic back pain.   PMH: Degenerative joint disease of the knees, hypothyroidism, asthma, seasonal allergies, obesity, dysmenorrhea, depression, chronic back pain, and insulin resistance.  Allergies:  Sudafed.  Meds:  Cyclobenzaprine and Lortab.			1						1	Drug hypersensitivity; Dyspnoea; Eye swelling; Ocular hyperaemia; Pruritus	FLU3~SANOFI PASTEUR~U2240AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0273123	02/27/2007	IA	68.0	68		F	02/21/2007	weakness and occasional discomfort to left arm.  no numbness or tingling									N	10/24/2006	10/26/2006	2	pt seen by cardiologist to rule out cardiac dx	PVT	OTH	Altace, Nexium, Synthroid, Toprol, Cardura, Zocor, Claritin	NONE	HTN, Hyperlipidemia, Hypothyroid, GERD, anxiety		IA07005	1						1	Asthenia; Discomfort; Limb discomfort	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71034~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0273128	02/27/2007	MI	46.0	46		F	02/27/2007	12/1/06 C/O stiffness and tenderness in her muscle at base of neck, posteriorly and between shoulders.  12/2/06 Pain became severe and worse yet on 12/3/06.  12/4 and 12/5: still very sore but a little better.  Tylenol, Motrin and heating pad didn't help.  States injection site not sore, no redness, did not develop a fever.  No problem with previous flu shots.  Instructed to try applying ice to area, but to call private provider is discomfort is severe.  Recovered approx. December 27th, 2006.									Y	11/29/2006	12/01/2006	2	Did not see private provider (too busy).	PUB	PVT	unknown	denies	Denies previous serious reaction after receiving a vaccination.  Denies history of Guillain-Barre or other neurologic disorder.  Denies allergies to vaccine components			1						1	Musculoskeletal stiffness; Myalgia; Pain	FLU3~SANOFI PASTEUR~U2307AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0273140	02/27/2007	UT	0.53	0	.5	M	02/27/2007	INTUSSUSCEPTION 03/22/07-ER report and DC summary received for 2/26/07 Ileocolic intussusception. Successfully reduced into the distal ileum with air contrast enema. Status post dehydration, resolved. History of persistent vomiting since 2/24/07. Diarrhea last week for 3 days with no bloody stools. No stools since 2/23/07- PE WNL except for abdomen slight distended and increased bowel sounds. No palpable mass. 03/23/07-records received for DOS 2/25/07-DX:gastroenteritis, dehydration.				Y					U	01/08/2007	02/24/2007	47	X RAY	UNK	UNK	ZANTAC	NONE				1						1	Intussusception; X-ray	DTAP~SANOFI PASTEUR~C2521AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2220BB~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0412F~3~IM~RL~HEP B (RECOMBIVAX HB)~1|IPV~SANOFI PASTEUR~Y1031~3~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~B58845D~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1111F~2~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0273148	02/27/2007	NC	2.0	2	.8	M	02/23/2007	large area (18 x 9 cm) redness left thigh, no induration-warm to touch									Y	02/21/2007	02/22/2007	1		PVT	PUB						1						1	Erythema; Skin warm	FLU3~SANOFI PASTEUR~U2284AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1095f~2~IM~LL~HEP A (VAQTA)~1	USA		Influenza
0273149	02/27/2007	NY	0.5	0	.5	F	02/23/2007	Redness in left leg after Influenza a immunization Dtap also given in same leg.									Y	02/23/2007	02/23/2007	0	NONE	PUB	PUB	NONE	NONE	latex			1						1	Erythema	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B051BA~3~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2285AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08674k~3~IM~RA~PNEUMO (PREVNAR)~1	USA		Influenza
0273153	02/27/2007	GA	0.52	0	.5	F	02/27/2007	PT had hives within hours of vaccines. Dad reports an egg allergy in his childhood. Hives resolved with in 24 hours.									Y	02/22/2007	02/22/2007	0	Pending appt with allergy/immunology clinic	PVT	PVT		NONE	NONE			1						1	Urticaria	DTAP~SANOFI PASTEUR~C2569AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2174CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0326~3~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~B08684C~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1232F~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0273147	02/28/2007	CO	14.0	14		M	02/27/2007	Patient fainted after 12 s were given within 1-2 min. Slowly recouperated.									Y	02/05/2007	02/05/2007	0	NONE	PUB	UNK		GERD, gastritis	NONE			1						1	Syncope	FLUN3~MEDIMMUNE VACCINES, INC.~500440P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB13AB~2~IM~LA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U18174AA~1~IM~~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B010AA~UNK~IM~RA~TDAP (BOOSTRIX)~1	USA		Influenza
0273181	02/28/2007	WV	0.54	0	.5	M	02/27/2007	Information has been received from a physician concerning a 6-month-old male who was vaccinated PO with the first, second and third 2.0 ml doses, respectively, of Rotateq. The physician reported that on the night of 15-FEB-2007, the patient developed hematochezia and was taken to the emergency room. The patient subsequently recovered. Upon internal review, hematochezia was determined to be an other important medical event. Additional information has been requested.				Y					Y	02/12/2007	02/15/2007	3	Stool Rotavirus RNA 02/15/2007 positive	OTH	OTH	UNK		UNK		WAES0702USA03484	1						1	Haematochezia; Rotavirus test positive; Clostridium difficile toxin test; Cough; Diarrhoea; Diarrhoea haemorrhagic; Haematochezia; Irritability; Mucous stools; Occult blood positive; Pyrexia; Rash; Rotavirus test positive; White blood cell count increased	RV5~MERCK & CO. INC.~1232F~3~PO~MO~ROTAVIRUS (ROTATEQ)~1|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B097AB~3~~RL~DTAP + HEPB + IPV (PEDIARIX)~2|FLU3~SANOFI PASTEUR~U2285A~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|PNC~PFIZER\WYETH~B36258B~3~~LL~PNEUMO (PREVNAR)~2|RV5~MERCK & CO. INC.~1232F~3~PO~MO~ROTAVIRUS (ROTATEQ)~2	USA	Emergency room visit	Influenza
0273206	02/28/2007	UT	19.0	19		F	02/28/2007	Patient had myalgias at day 7 post vaccine. Severe headache global x <24 hours. Severe muscle weakness. Severe fatigue, symptoms routine except headache which disappeared in 24 hours.  03/07/8/07-records received from rheumatology consultation for DOS 03/02/07-Impression: Myalgias, dysethesias hands and feet, increased fatigability, oral ulceration/cankers;possible rare reaction to either flu or Gardasil. Rule out vasculitis, lupus and other connective tissue disease. C/O severe body pain, weakness, headache lasted 1 day but has had persistent generalized muscle pain. Transient numbness in hand, face and feet. Eyes feel sore, some twitching of eyelids. PMH: Seizure as infant after pertussis vaccine and never completed the series. No recurrence of seizure and did not appear to be febrile seizure.  Mother has multiple sclerosis.  PE:Muscles tender to palpation pretty uniform throughout body, not so much in hands as in forearms, arms, trunks, legs, calves.				Y					N	01/22/2007	01/29/2007	7	Severe reaction Gardasil and Influenza vaccine given. Labs:WNL. Rheumatoid factor negative. CK 64 repeat CK 65.	PVT	UNK			Pertussis vaccine.   3/7/07 records received Seizure as infant after pertussis vaccine and never completed the series.  Mononucleosis at age 16. Migraines.	seizure~Vaccine not specified (no brand name)~1~0.00~Patient|aeizure~Vaccine not specified (no brand name)~1~0.00~Sibling		1						1	Fatigue; Headache; Muscular weakness; Myalgia; Vaccination complication; Antinuclear antibody negative; Arthralgia; Blood creatinine normal; Erythema; Fatigue; Headache; Rash; Rash macular	FLU3~SANOFI PASTEUR~U2177AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0688F~2~IM~LA~HPV (GARDASIL)~1|HPV4~MERCK & CO. INC.~0688F~2~~UN~HPV (GARDASIL)~2	USA	Emergency room visit	Influenza
0273231	03/01/2007	VA	64.0	64		F	02/22/2007	Patient complain of pain in her arm at injection site. She had quarter size redness and swelling which resolved in 2 or 3 days after the injection but she still has pain. Pain began about one week after injections.									U	01/08/2007	01/15/2007	7		PUB	PUB	NONE	NONE	NONE			1						1	Erythema; Injection site pain; Swelling	FLU3~SANOFI PASTEUR~U2307AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0273233	03/01/2007	LA	1.71	1	.7	M	02/21/2007	Left leg with large area redness around injection site.									U	02/19/2007	02/20/2007	1		PVT	PVT		NONE				1						1	Injection site erythema	DTAP~SANOFI PASTEUR~C2552AA~4~~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2174JA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0324~3~~RL~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0273234	03/01/2007	IN	0.53	0	.5	M	01/19/2007	MMR/Varicella given out of recommendation range of 12 months or over. Flu vaccine given out of recommendation range (3 weeks early). No adverse reaction at this time.									Y	01/18/2007				OTH	OTH		NONE	NONE			1						1	Inappropriate schedule of drug administration; No adverse effect	FLU3~SANOFI PASTEUR~UT2176KA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~1332F~1~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0273257	03/01/2007	RI	0.5	0	.5	F	03/01/2007	LOCAL REACTION TO LT THIGH 2X1, SLIGHTLY RAISED, RED.  PAINFUL TO TOUCH.									Y	02/28/2007	02/28/2007	0	NONE	MIL	MIL		NONE	NKA			1						1	Local reaction; Pain; Rash	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC1B069AA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2200RA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08684C~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1165F~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0273260	03/01/2007	AL	61.0	61		M	03/01/2007	Developed weakness right side that has since resolved.  Later, 12/20/2006 developed pain and muscle spasm upper right trunk.  On exam 2/28/2007 had mild decrease right bicept reflex, full strength.				Y					N	11/17/2006	11/20/2006	3	MRI head (normal), carotid doppler(negative), echocardiogram (normal), chest x-ray, general chemistry profile, CBC	UNK	UNK	Vasoretic 10/25/day, Diazepam 5 mg/day, Aspirin 325mg/day	None	Hypertension, Hemochromatosis,Hyperlipidemia			1						1	Asthenia; Chest X-ray; Echocardiogram normal; Full blood count; Laboratory test; Muscle spasms; Nuclear magnetic resonance imaging normal; Pain; Ultrasound Doppler normal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71034~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0273276	03/01/2007	NH	7.0	7		F	03/01/2007	Whole body, bright red, warm, itching-breaking out of hives, legs starting to swell-given Benadryl 25 mg po qd sent to hospital ER admit time 4:00-called office with complaints 5:45 (approx. vac time 4:30-4:45)				Y					Y	02/26/2007	02/26/2007	0		PVT	UNK		chronic history gastric paresis-food allergies: milk, soy, corn, beef	Zithromax, Cyprohepatadine, food allergies			1						1	Erythema; Oedema peripheral; Pruritus; Skin warm; Urticaria	FLU3~SANOFI PASTEUR~uu2271A9~4~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1306F/2741F~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0273286	03/02/2007	GA	29.0	29		F	02/20/2007	Pt received the flu shot on 9 Dec, 2006 and on 9 Jan 2007 RT side of her jaw had a constant pain. On Jan 17 she developed slurred speech. Went to ER on Jan 18 and discharged on the 20th. Next she had L foot numbness that spread into her chest. Could not walk without assistance. Was transferred to medical center for more tests. Diagnosis was Sub acute encephalomyelitis due to the influenza vaccine. 03/05/07-records received from facility for DOS 01/27-02/03/07-DC DX: subacute encephalomyelitis due to influenza vaccine. HX:1/9/07 right jaw ache, 1/17/07 acutely developed slurred speech, seen in ER 1/18/07, admitted. Brain scan and EEG at that time normal. 1/20/07 developed left foot numbness spread to right side of belly and chest, right hip tender to touch, bowel urgency and 'panic attacks' three times over 5 days. Difficulty walking and changes in her hand writing.  PE: speech slurred, cranial nerve VII nasolabial flattening noted on smile, no facial asymmetry on eyebrown rise or eyelid closure. Cranial nerve XII tongue deviates to right on protrusion, decrease strength on right lateral deviation of tongue.  Motor:no atrophy/drift. normal tone, 4/5 strength on ankle dorsiflexion on right side otherwise 5/5 throughout. Sensation:pinprick was decrease 40% on left side up to mid chest and upper back. Inconsistent response on proprioception testing on distal right lower extremity. Vibration intact. Reflexes:DTR 2 plus and symetric. Plantar responses flexor. Gait:native was unstable and with short steps, unable to walk on toes, heel or heel to toe.				Y	Y	10			U	12/09/2006	01/09/2007	31	MRI C-spine, MRI T-spine, Head CT, EEG a lot of lab work = Blood culture = NGTO, Fungal culture - NGTD, HCG gl = Negative, SPEP = Negative, Anti-thyroid Ab, CX= NGTD, Lupus = Negative, HIV-1 = Negative CBC:WNL, BMP, WNL. Lyme negative, folate 27, vitamin b-12 494. Coag:WNL. ANA positive times 2 1:320 with speckled and homogenous pattern. CSF:on 1/22/07-RBC 802, WBC 18, Glucose 57, Protein 44, Lymph 92, polys 8, Gram stain negative. fungal culture pending. HAV AB positive.ESR 8, CRP 0.087,  MRI C-spine(1/21/07) minimal bulging, mild straightening of cervical spine consistent with spasm.Intramedullary nonenhancing lesion at C6 in R aspect of cord MRI T-spine (1/21/07) normal. Intramedullary nonenhancing lesion at T9-10 in posterior aspect of cord. Head CT (1/20/07) normal MRI brain:ovoid area of abnormal signal in left anterior parietal white matter or gray white junction favoring localized ischemic infarct and also acute demyelinating process was not excluded but considered less likely. Subsequent MRV negative. MRA of neck concern for large vessel arteritis EEG: mildly abnormal due to presence of occasional small sharply contoured waves seen on left and right hemisphere which could occur and just can be seen in headaches. Bilateral solid ovarian masses by transvaginal US.	MIL	MIL	NONE	NONE	Allergic to ASA			1						1	Abasia; Blood culture negative; Computerised tomogram; Dysarthria; Electroencephalogram; Encephalitis; HIV test negative; Hypoaesthesia; Nuclear magnetic resonance imaging; Pain in jaw	FLU3~SANOFI PASTEUR~U2310AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0273298	03/02/2007	IL	80.0	80		F	02/18/2007	Pt came into the pharmacy on 2-12-2007 said her arm is still sore/limited movement without pain-right arm where injection was given. Arm before injection was fine after injection - maybe next day stiff & sore - never got better but we did not hear from patient until the date of report. Sorry to be so vague on onset.									N	10/24/2006				OTH	PUB		NONE	NONE			1						1	Injected limb mobility decreased; Musculoskeletal stiffness; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ZF600911~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0273300	03/02/2007	MA	36.0	36		F		2/15/07 received Tetanus vaccine on left arm at clinic. (vax also given to husband) came back to clinic next day with large reddened swollen area around site of immunization, that was tender to touch, feverish; refers to provider. Case seen by ER on 2/16/07, Keflex x 10 days, warm compress to site x3-4 days, returning problems. Public health nurse spoke with pt on 2/23/07-feeling better, arm less red, swelling decreased.				Y					Y	02/15/2007	02/15/2007	0	dx-cellulitis of upper limb	PUB	PVT	NONE	NONE	allergy to sulfa		MA0706	1						1	Cellulitis; Injection site erythema; Injection site pain; Injection site swelling; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72566~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TTOX~MASS. PUB HLTH BIOL LAB~Td 153~UNK~UN~LA~TETANUS TOXOID, ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0273306	03/02/2007	FL	1.0	0	1	F	02/21/2007	Seizures post MMRV with MRI evidence of brain stem ischemia. Residual spasticity onset fever 10 d past dose MMRV, Prevnar, Hib, Influenza 03/15/07-records received from facility for DOS 11/14-11/28/06 DC DX: respiratory syncytial virus bronchiolitis, resolved. Encephalopathy with basal ganglia lesions of unknown etiology. Seizure disorder. Dysphagia. mild spasticity. PMH:no significant medical history.  Developed fever and neurologic changes 11/14/06 approximately 10 days after vaccinations. initial symptoms included stiffening of legs, sucking type action of tongue and temperature to 104 and somnolence.  Remains with cognitive delays including Language, social, and reston  Follow-up: Pt has a confirmed diagnosis of: Complex I deficiency Mitochondrial Encephalomyopathy. This is an inherited metabolic defect, and the direct cause of her seizures and brainstem atrophy. The seizures were likely triggered by fever from the MMR vaccine, but not causally related otherwise. Formal report will be forwarded if requested, and approved by pt's parents.			Y	Y	Y	14			N	10/26/2006	11/05/2006	10	MRI brain records received 3/15/07-EEG: abnormal demonstrating what appears to be encephalopathic picture associated with spike activity from the left posterior head region.  CSF and lab work did not reveal any conclusive finding as to the etiology of her central nervous system lesions. MRI focal abnormalities with increased signal on T2 weighted images in basal ganglia bilaterally with changes in deep white matter signal as well felt to be suggestion of recent ischemia or demyelinating process.	PVT	UNK		NONE	probable social/language delay			1						1	Brain stem ischaemia; CSF test normal; Convulsion; Electroencephalogram abnormal; Muscle spasticity; Nuclear magnetic resonance imaging brain; Pyrexia	FLU3~SANOFI PASTEUR~U219AA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1031~UNK~~RL~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~0832F~UNK~~~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08683C~UNK~~LL~PNEUMO (PREVNAR)~1	USA	Life Threatening,Hospitalisation	Influenza
0273309	03/02/2007	WV	4.0	4		M	12/08/2006	12/06/06 AM redness and swelling noted at injection sites. Gave Tylenol and used, swelling, redness and hardness spread up to his shoulder on 12-7-06. To his physician, mother said he was given steroids by his Dr.				Y					Y	12/05/2006	12/06/2006	1		PUB	PUB		NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site swelling	DTAP~SANOFI PASTEUR~U1615CA~5~IM~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1177AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1050~4~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~0819F~2~SC~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0273310	03/02/2007	VA	3.0	3		M	03/01/2007	Redness and swelling at site (size of quarter).									Y	02/21/2007	02/28/2007	7		PUB	PVT				~Influenza (Seasonal) (no brand name)~1~0.00~In Patient		1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2307AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0273330	03/02/2007	NM	8.0	8		F	03/02/2007	erythema and central induration of Right upper arm 2 days after shot given				Y					Y	11/14/2006	11/16/2006	2		PVT	PUB		none	none			1						1	Erythema; Induration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72005~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0273332	03/02/2007	IA	18.0	18		M	03/02/2007	PAIN IN DELTOID MUSCLE TWO WEEKS									N	02/15/2007	02/15/2007	0		PVT	PVT		RUNNY NOSE, SORE THROAT				1						1	Myalgia	FLU3~SANOFI PASTEUR~U2262AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0273340	03/03/2007	TX	3.0	3		M	03/03/2007	Started with a rash that resembled eczema and spreaded all over his body within a week after a flu vaccination containing thimerosal.  Behavioral he became hyper and listless.										11/02/2006	11/03/2006	1	I have sent a hair sample to be tested for heavy metals, and currently I am waiting for the results.	PVT	PVT			His previous eczema was eradicated using alternative medicine; however, it came back after the vaccine.  Previously he was tested for food allergies and came back negative, including eggs.			1						1	Condition aggravated; Eczema; Listless; Psychomotor hyperactivity; Rash	FLU3~SANOFI PASTEUR~~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0273353	03/05/2007		36.0	36		F	03/05/2007	The Pt.'s left upper arm developed exuberent local reaction with erthyema, warmth, tenderness with systemic fatigue, fever.									Y	02/26/2007	02/27/2007	1		MIL	MIL		zero illness present	Behchet's disease, recurrent nephralithiasis, recurrent UTI'S, multiple pharyngitis episodes			1						1	Erythema; Fatigue; Local reaction; Pyrexia; Skin warm; Tenderness	FLU3~SANOFI PASTEUR~U2259AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0273389	03/05/2007	AL	0.56	0	.6	M	12/06/2006	Petechial rash noted 24 Nov 06. Resolving 18 Dec.									Y	10/25/2006	11/26/2006	32	CBC/ESR with PCR River, Metabolic	PVT	PVT						1						1	Full blood count; Metabolic function test; Petechiae; Polymerase chain reaction	DTAP~SANOFI PASTEUR~U1891BA~3~~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2176FA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE963AA~3~~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B086468~3~~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0940F~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0273392	03/05/2007	NE	1.33	1	.3	F	02/28/2007	Parents heard a loud cry at 3:30 am - child was found seizuring - lasted about 1 minute. Child was also very hot - temp not taken. Child had been medicated throughout day with Tylenol following vaccinations. 03/12/07-records received from facility for DOS: 02/16/07-ER visit for second seizure in a week. After receiving immunization developed high fever and had a seizure diagnosed as febrile seizure. Same episode today. Temp in ER 100.9. Pulse 210. Resp 30. PE: posterior pharynx cobblestone appearance with drainage. Neck mild cervical lymphadenopathy bilaterally.  DX:Fever. Possible febrile seizure				Y					Y	02/07/2007	02/08/2007	1	CT scan, EEG, Influenza screen Labs received 3/12/07-Lab: influenza screen negative. CT and EEG normal.	PUB	UNK	NONE	URI one week prior to vaccinations	NONE		NE200701	1						1	Computerised tomogram; Convulsion; Crying; Electroencephalogram; Influenza serology; Skin warm	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B036BA~UNK~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2176KA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1209F~UNK~IM~~HEP A (VAQTA)~1|HIBV~MERCK & CO. INC.~1084F~UNK~IM~RL~HIB (PEDVAXHIB)~1|MMRV~MERCK & CO. INC.~0976F~UNK~SC~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08674D~UNK~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0273395	03/05/2007	WY	37.0	37		F	01/17/2007	Enlarge lymph node under Right arm/ same arm as shot felt like bruising for 2 days, continues to be swollen but less. U/S x 2, 2 blood tests, 4 doctor appointment, including surgeon.				Y					N	11/07/2006	11/09/2006	2	U/S - enlarged lymph node	PUB	PVT	Birth Control Pills, Zithromax in October for sinus issue	NONE	Bursitis left shoulder since they had cortisone shot July and end of Sept 2006 in left shoulder.			1						1	Lymphadenopathy; Ultrasound scan abnormal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71639~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0273415	03/05/2007	CO	16.0	16		F	03/05/2007	Received first vaccine on 11/08/2006  never reported it until 03/01/. Area where she got Gardasil injection and tender and Hypo-pigmented.    Left Arm 32mm x 24 mm 11/08/2006 Right Arm 22 x 25 mm 01/08/2007									N	11/08/2006				PVT	PVT	Yaz, Celexa					1						1	Injection site pain; Injection site reaction; Pigmentation disorder	DTP~SANOFI PASTEUR~C2609AA~1~IM~RA~DTP (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U2255AAA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0955F~1~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0273448	03/05/2007	GA	48.0	48		F	02/03/2007	Ear feeling clogged, hearing loss, constant sinus drainage, sore throat. 4 visits to Dr.				Y					U	11/04/2006	11/04/2006	0		MIL	UNK			None			1						2	Deafness; Ear discomfort; Oropharyngeal pain; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500431P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Emergency room visit	Influenza
0273451	03/05/2007	CA	3.0	3		F	03/05/2007	3/1/07: Fever 103, onset in a.m., sib with documented Influenza Type B by rapid Ag test. Treated with Tamiflu x 5 days.				Y					N	12/21/2006	03/01/2007	70	N/P S was for Influenza A/B Ag: (+) Influenza Type B, (-) Influenza Type A	PVT	PVT	NONE	NONE	NONE			1						1	Influenza; Pyrexia	FLU3~SANOFI PASTEUR~U2249AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0273452	03/05/2007	CA	9.0	9		F	03/05/2007	2/26/07 Fever 104 x 1 day, c/o lower abdominal pain, lower back stiffness, nasal congestion, residual cough from previous sinusitis 2/17/07; completed Augmentin 3 days ago; treated with Tamiflu x 5 days.				Y					Y	11/09/2006	02/26/2007	109	N/P for Influenza A + B Ag: (+) Influenza Type B, (-) Influenza Type A	PVT	PVT	Motrin, Augmentin 400 mg BID x 10 days completed 3 days before	NONE	NONE			1						1	Abdominal pain; Cough; Influenza; Musculoskeletal stiffness; Nasal congestion; Pyrexia	FLU3~SANOFI PASTEUR~U2164AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0273521	03/07/2007	NC	41.0	41		M		after vaccine pt had injection site reaction with flushing of face.  Pt complained of lightheadedness pt was given 25 mg of Benadryl and assessed for further treatment over next 2 hrs.									Y	02/20/2007	02/20/2007	0		PVT	PVT						1						1	Dizziness; Flushing; Injection site reaction	FLU3~SANOFI PASTEUR~U2215AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0273524	03/07/2007	TX	1.08	1	.1	F	02/21/2007	Developed erythema multiforme				Y					Y	01/04/2007	01/14/2007	10		PVT	PVT	NONE	Otitis	NONE			1						1	Erythema multiforme	FLU3~SANOFI PASTEUR~U21751A~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0240F~1~~LL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~1330F~1~~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0273529	03/07/2007	TN	58.0	58		U		Fever 102 deg for 2 days, left arm red and inflamed from shoulder to elbow after receiving the pneuoccal vaccine occurred within 24 hours of injection on 10-16-06. Treated with moist pack and Advil, Hz blockers.									Y	10/16/2006	10/16/2006	0	NONE	OTH	PVT		NONE	Pulmonary as related to severe allergies of unknown source			1						1	Erythema; Inflammation; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71034~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1006P~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0273532	03/07/2007	IL	21.0	21		F	01/19/2007	Sore arms and achy all over.  Right upper arm (75 x 55 mm) very erythematous, warm and tender with pneumovax left upper arm (25 x 18 mm) mildly red and tender with flu vaccine.									Y	12/12/2006				PUB	UNK						1						1	Erythema; Pain; Pain in extremity; Skin warm; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71643~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0619F~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0273533	03/07/2007	TX	1.0	1	.0	M	02/21/2007	Development of erythema multiforme				Y					Y	01/09/2007	01/21/2007	12	NONE	PVT	PUB		Otitis media	Atopic dermatitis			1						1	Erythema multiforme	DTAP~SANOFI PASTEUR~U1891CA~1~~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT2174JA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0701F~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0249F~1~~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0273542	03/07/2007	MT	1.02	1	.0	F	02/26/2007	T- 102 degrees within 24 hours, dark purple hands and feet x 2-3 days, no treatment.				Y					Y	02/21/2007	02/22/2007	1	NONE	PVT	PUB	NONE	URI	NONE			1						1	Body temperature increased; Skin discolouration	FLU3~SANOFI PASTEUR~U2177A~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1436F~3~IM~LL~HIB (PEDVAXHIB)~1|MMRV~MERCK & CO. INC.~1203F~1~IM~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08684H~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0273543	03/07/2007	FL	1.5	1	.5	M	03/02/2007	Non-febrile seizure approximately 15 minutes returned to baseline by the and evaluation by ER doctor. 03/20/07-records received from facility for DOS 2/16/07-DX:febrile post injection Seizure. HX:became unresponsive to voice, eyes pulled to right side, lasted 1 minuted. Temp 99.6.				Y					Y	02/16/2007	02/16/2007	0	CBC, BMP Blood Cx, UA (All normal) records received 3/20/07-Labs WNL.	PVT	UNK	Rondec DM	URI mild	NONE			1						1	Blood culture negative; Convulsion; Full blood count normal; Urine analysis normal	DTAP~SANOFI PASTEUR~C2554AA~4~~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U22010A~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~SMITHKLINE BEECHAM~AHAVB133AB~2~~LL~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~20326~3~~RL~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0273545	03/07/2007	MA	1.01	1	.0	M	11/14/2006	Onset rash 11/13/06 on face and arms spread to legs 11/14/06. Few vesicular lesions Left buccal mucosa and lower Left gingival surface. Papular rash on forehead, around eyes,  chin, hands upper arms, lower legs. Slightly vesicular but no true vesicles. Plan = no aspirin. Calamine or Aveeno PRN.				Y					Y	12/30/2004	11/13/2006	683		PUB	PUB	Pulmicort Neb, Albuterol Neb	Cough, Wheeze, Asthma exacerbation	Asthma, Prematurity (33 wks), low birth wt.			1						1	Rash; Rash papular; Rash vesicular	FLU3~SANOFI PASTEUR~U1445AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1300N~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A57561E~4~~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0762P~1~~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0273546	03/07/2007	IN	15.0	14		M	02/27/2007	Mother reports rash on patient's face all over with redness, swelling, itching starting 2-4 weeks after immunizations. Condition is persistent and mother reports worsening over time. Pediatrician diagnosed as questionable allergic reaction. Prescription: Benadryl PRN and Prednisone 20 mg BID x 7 days. Unresolved.				Y					N	12/26/2006	01/09/2007	14		PUB	PUB						1						1	Erythema; Hypersensitivity; Pruritus; Rash; Swelling	FLU3~SANOFI PASTEUR~U2258AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0672R~UNK~IM~RA~HEP B (FOREIGN)~1|IPV~SANOFI PASTEUR~Y1068~UNK~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0253F~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|MNQ~SANOFI PASTEUR~U2142AA~UNK~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2638AA~UNK~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0273550	03/07/2007	MA	50.0	50		F	02/26/2007	Patient was asleep and awoke approximately 3 hours after vaccination with tremors. Over then next 2-3 wks, developed Left sides weakness, numbness, tingling. Developed Left leg limp. Approximately 3-4 wks after vaccine, developed Right upper arm weakness along with worsening Left sided symptoms. Had migraine headaches, developed stuttering, numbness and tingling in face. Complain of feeling diaphramatic symptoms stuttering worsened with increased fatigue. Weight loss of 25 lbs. Treatment - under care of primary physician, doctor name reported. Plan has been: bedrest, nutritional  and herbal supplements from a nutritionist, chiropractic care, specialist and hospital. IgG taken orally, Super ESS for re-myelination of nerves. Complain of her mother had a bad reaction many years ago to a shot. Mother required hospitalization. 04/19/07-records received from providers. DX: Syndrome is partly anxiety but more likely reflex dysautonomia associated with the  nervous system being hyperactive. C/O left shin numbness, front of her head bilaterally and down into the neck. Paresthesias across forehead and into left side of face. Spread down into shoulder and to elbow.				Y					U	11/29/2006	11/29/2006	0	CT of head, MRI and MRA to R/O stroke, Full cardiac w/u, thermal EMG, Mult blood work records received 4/19/07-MRI brain, MR angiogram and venogram, echocardiogram normal. Carotid doppler less than 30% ICA stenoses both sides and anterograde vertebral flow.  Labs: TSH 1.364. Lyme negative, ESR WNL. Chemistry Report WNL. CBC WNL.	PUB	PUB	NONE	NONE	NONE, c/o sensitivity to medications			1						1	Blood test; Computerised tomogram; Dysphemia; Electromyogram; Fatigue; Gait disturbance; Hemiparesis; Hypoaesthesia; Hypoaesthesia facial; Migraine; Muscular weakness; Nuclear magnetic resonance imaging; Paraesthesia; Tremor; Weight decreased	FLU3~SANOFI PASTEUR~U2271AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0273559	03/07/2007	FL	1.4	1	.5	M	03/07/2007	Parent states diarrhea,  projectile vomiting and high fever beginning at 3 AM today. Child is listless with dark circles under his eyes and unable to keep retain fluids including Tylenol.				Y					U	03/06/2007	03/07/2007	1	Unkown	PUB	PUB	None	None reported	None			1						1	Dark circles under eyes; Diarrhoea; Fluid imbalance; Listless; Pyrexia; Vomiting projectile	DTAP~SMITHKLINE BEECHAM~AC14B027AA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2201DA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0507F~1~IM~LL~HIB + HEP B (COMVAX)~1|HEPA~MERCK & CO. INC.~0804F~1~IM~RL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~1530F~1~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0273582	03/07/2007	GU	47.0	47		M	03/07/2007	Swelling on left arm starting at the site of injection and going down toward elbow with pain.				Y					U	02/19/2007	03/01/2007	10		PUB	OTH	NONE	NONE	NONE			1						1	Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2260AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U1730EA~UNK~~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0273638	03/08/2007	VT	70.0	69		F	03/05/2007	Onset 1/17/07 of weakness in legs (rubbery feeling), numbness in hands progressing to biceps - T-102 - neuro consult with diagnosis of Sensory Guillain Barre - in ICU on ventilator and receiving IVIG. In rehab 2-5 ---> 2-28-07: discharged with diplopia; right 7th cranial nerve palsy; dysarthria; dysphagia and decreased mobility. 03/19/07-records received from facility for DOS-01/18/07-02/01/07 and acute rehabilitation from 02/05-02/28/07 DC DX: Guillain Barre Syndrome DC DX: Neurological disorder with acute inflammatory demyelinating polyneuropathy Guillain-Barre Syndrome. Right VII cranial nerve palsy. Diplopia. Dysphagia. Dysarthria. Steroid versus ICU psychosis, resolved. Depression/Anxiety. Pulmonary issues, status post pneumonia, History of COPD and pulmonary involvment of AIDP. Decreased mobility. Decreased ADL. Admission to acute inpatient rehabilitation. Presented with C/O numbness in hands and weakness in legs. Noted a slight cough running nose and watery eyes recently. Temp of 102. Admitted. Continued to have muscular weakness, ataxia and difficulty with ambulation.  Intubated and extubated.			Y		Y	42	Y	Y	Y	12/18/2006	01/17/2007	30	Neurology Exam records received 3/19/07-CBC:normal. Sed rate 55. IGA deficiency. CSF glucose 62, protein 35, Streptococcal antigen negative. ANA titer 1:40 and RPR nonreactive. CSF cultures negative and lyme serology negative.  MRI of brain negative.  CXR negative. Barium swallow: showed a very weak swallow with evidence of penetration and this patient is at risk for aspiration.	PVT	OTH	UNK	NONE	NONE records received 3/19/07-PMH:Hypothyroidism. Telangiectasia. Hyperlipidemia. Migraines. Depression. COPD.			1						1	Body temperature increased; Diplopia; Dysarthria; Dysphagia; Guillain-Barre syndrome; Hypoaesthesia; Intensive care; Life support; Mobility decreased; Muscular weakness; Neurological examination; VIIth nerve paralysis	FLU3~SANOFI PASTEUR~U2164AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0273639	03/08/2007	FL	37.0	37		M	03/05/2007	Excessive vomit followed with cough.									U	02/27/2007	02/27/2007	0	CMP, CBC	MIL	MIL		NONE	NKDA			1						1	Cough; Full blood count; Metabolic function test; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~U2286AA~2~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0273686	03/08/2007	MO	42.0	42		M	03/07/2007	Within 15 minutes of injection patient developed urticaria, swelling, redness, pain, diaphoresis, headache, and nausea. Patient was given Benadryl 50mg and Motrin 800mg within 30 mins of the injection. The patient received a steroid pack with rapid improvement.									Y	11/08/2006	11/08/2006	0		PVT	OTH	Teveten HCT, Cymbalta, Multivitamin	NONE	IV Iodine			1						1	Erythema; Headache; Hyperhidrosis; Nausea; Pain; Swelling; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71641~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0273688	03/08/2007	IN	1.48	1	.5	F	03/08/2007	FIRST TIME SEIZURE LATER IN SAME DAY FOLLOWING INJECTION 03/16/07-records received from facility for DOS 03/05/07 Seen by PCP with cold like picture, began amoxicillin, and received flu immunization. Expereienced a shaking spell for 5-10 seconds, unresponsive, limp. Seen in ER somnolent and irritable. VS unremarkable. Temp99.  Impression:febrile convulsion or adverse reaction to immunization of flu vaccine. Bronchitis.					Y				Y	03/05/2007	03/05/2007	0	records received 3/16/07-CT head, incomplete aeration of maxillary and ethmoid sinuses may be due to patient's young age or chronic sinusitis. Brain itself is normal no skul abnormalities. EEG:no clear evidence seen in this sleep or waking records for any focal or diffuse abnormality. No epileptiform discharges seen. RSV:positive Nose and throat cultures negative. pertussis by PCR:negative.	UNK	UNK		records received 3/16/07-cold				1						1	Convulsion	FLU3~SANOFI PASTEUR~UT2176KA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0273691	03/08/2007	NY	12.0	12		F	03/08/2007	First seizure 10 days after first gardasil vaccine.  Two months later, second seizure episode 16 days after second gardasil.  08/22/2008 MR received from Neuro consult dated 12/22/06 (as well as some past hx.) Assessment: 1st Seizure.  Most likely a complex partial seizure with secondary generalization. Pt was trying to speak but unable to do so, then had a 30-40 sec grand mal seizure which may have begun in the legs. Neuro exam WNL. 9/11/2008 2 ER recs received dated 12/21/2006 and 6/16/2007 with DX: 1st seizure and seizure.  Pt 1st presented 12/21/06 following 30-40 sec seizure.  Seen 6/17/07 after 2 episodes of lip quivering and feeling of throat closing which was a similar aura with last grand mal seizure. C/o headache after.				Y					Y	12/11/2006	12/21/2006	10	MRI and EEG.. Labs and Diagnostics:  Brain MRI WNL.  EEG WNL. Fragile X test with normal karyotype.	UNK	UNK			Developmental delay. PMH: developmental delay-non progressive. Occasional h/a. Lyme Disease age 5. Allergy to nuts, hives from Amoxicillin.	seizure~HPV (Gardasil)~2~12.30~In Patient		1						1	Electroencephalogram; Nuclear magnetic resonance imaging; Convulsion; Vaccine positive rechallenge; Convulsion; Electroencephalogram normal; Gaze palsy; Laboratory test; Loss of consciousness; Nuclear magnetic resonance imaging normal	FLU3~SANOFI PASTEUR~u2166mA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1163F~1~IM~LA~HPV (GARDASIL)~1|HPV4~MERCK & CO. INC.~~2~UN~UN~HPV (GARDASIL)~2|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~3|HPV4~MERCK & CO. INC.~1163F~1~IM~RA~HPV (GARDASIL)~3	USA	Emergency room visit	Influenza
0273693	03/08/2007	NY	45.0	45		F	03/08/2007	12/28/06 Td given in left deltoid, influenza given in right deltoid. Email from patient (coworker)to county nurse on 2/15/07 stating, Right after I got the tetanus shot, the arm I got it in got really sore which I expected.  Unfortunately, the pain hasn't gone away and I'm having problems straightening my arm out.  I know I didn't injure the elbow or strain it but I just can't get rid of the pain in the elbow and now the wrist is starting to bug me. We referred the individual to her primary care physician. pc to patient on 3/5/07 found that patient did not seek medical attention. She states now she occasionally needs to pick her left arm up with her right one to move it.										12/28/2006	12/28/2006	0		PUB	UNK	Zocor and Avalide	denies	Hay Fever, hypertension, hyperlipidemia			1						1	Arthralgia; Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2312AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~MASS. PUB HLTH BIOL LAB~Td 156~UNK~IM~LA~TD ADSORBED (TDVAX)~1	USA		Influenza
0265473	03/09/2007	IL	56.0	56		M	03/09/2007	Client delayed reporting adverse reaction.  The day after receiving influenza, client reports severe hives.  Client notified PMD and was prescribed 5 days of steroids which resolved symptoms.									Y	10/18/2006	10/19/2006	1	none	PUB	PVT		none	none			1						2	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70279~6~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0271927	03/09/2007	CT	0.54	0	.5	M	03/06/2007	Information received on 28 February 2007 from another manufacturer, report # WAES0702USA03318. The initial reporter to this manufacturer had been the FDA. Verbatim from the report: Information has been received from the FDA through the CDC concerning a 6 month old male with eczema and recurrent wheezing and a history of respiratory syncytial virus bronchiolitis who on 29-Jan-2007 was vaccinated PO with a second dose of Rotateq (lot # 654663/0942F). Concomitant vaccination administered that day included a IM second dose of Pediarix (lot # AC21B097AB), an IM first dose of Fluzone (lot # UT2191KA) and an IM second dose of Prevnar (lot # B08691A). There were no other medications. The patient developed explosive diarrhea and emesis shortly after the vaccines were given. On 06-Feb-2007 the patient was admitted to the hospital for worsening vomiting. On the morning of 07-Feb-2007, he was found to have intussusception. A stool culture and viral studies were to be done. An ultrasound showed ileocolic intussusception and the patient was transferred. The patient's outcome was not known. The patient's adverse events were considered to be life threatening. Additional information has been requested.			Y	Y	Y	0	Y		U	01/29/2007	01/29/2007	0	07/Feb/2007: ultrasound-ileocolic intussusceptus	OTH	OTH		Eczema; Wheezing	Medical history: respiratory syncytial virus bronchiolitis		200700587	1						2	Diarrhoea; Intussusception; Ultrasound scan; Vomiting; Culture stool; Diarrhoea; Intussusception; Ultrasound scan abnormal; Vomiting; Barium enema; Diarrhoea; Intussusception; Ultrasound scan; Ultrasound scan abnormal; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~ac21b097ab~3~IM~UN~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~ut2191ka~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~b08691a~3~IM~UN~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0942F~3~PO~MO~ROTAVIRUS (ROTATEQ)~1|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B097AB~2~IM~~DTAP + HEPB + IPV (PEDIARIX)~2|FLU3~SANOFI PASTEUR~UT2191K~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PNC~PFIZER\WYETH~B08691A~2~IM~~PNEUMO (PREVNAR)~2|RV5~MERCK & CO. INC.~0942F~2~PO~MO~ROTAVIRUS (ROTATEQ)~2|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B097AB~2~IM~~DTAP + HEPB + IPV (PEDIARIX)~3|FLU3~SANOFI PASTEUR~UT2191KA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~3|PNC~PFIZER\WYETH~B08691A~2~IM~~PNEUMO (PREVNAR)~3|RV5~MERCK & CO. INC.~0942F~2~PO~MO~ROTAVIRUS (ROTATEQ)~3	USA	Life Threatening,Hospitalisation	Influenza
0273709	03/09/2007	NH				F	03/06/2007	Initial report received on 01 March 2007 from an other manufacturer (no report number), who received the report through their National Service Center from a nurse in the United States. The other manufacturer forwarded the report to mfr, who forwarded the report to mfr. A female patient, with a history of allergy to lactose, had received an INFLUENZA vaccine as a child. The date of vaccination, trade name, manufacturer name, route and site of administration were not reported. Reportedly, at an unspecified amount of time later, the patient was paralysis for about three days. The patient subsequently sought medical attention and intervention to prevent serious criteria. Reportedly, the patient recovered.				Y					Y					UNK	UNK			The patient has a history of allergy to lactose.		200700604	1						1	Paralysis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0273710	03/09/2007	AZ	22.0			F	03/06/2007	Initial report received on 01 March 2007 from another manufacturer, no report number provided. The initial reporter to this manufacturer had been a health care professional. A 22-year-old female patient had received an injection of Influenza Vaccine, manufacturer reported, lot number not reported; in November 2006. On an unspecified date post-immunization in November 2006, the patient developed an anaphylactic reaction which required medical attention. The patient had also received an injection of Gardasil in October 2006 with no incident. Additionally medically relevant information was not provided.				Y						11/01/2006	11/01/2006	0		UNK	UNK					200700605	1						1	Anaphylactic reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0273741	03/09/2007	TX	54.0	5		F	03/05/2007	1 Day following immunizations, site of varicella vaccine, left posterior upper arm, became red, swollen and increased in severity. Seen at office 3/2/07 with swelling of 10 cm x 13 cm with warmth and erythema to left posterior upper arm - 82 mm papule in center - treated with Motrin/Tylenol PRN, warm compresses QID.									U	03/04/2007	03/05/2007	1	NONE	OTH	PUB	ALBUTEROL, PULMICORT, ADDERALL, OMINICEF, ENTEX liquid	asthma, Influenza A, Serous otitis media	Asthma, anemia, Strep throat			1						1	Asthma; Erythema; Influenza; Injection site erythema; Injection site swelling; Otitis media; Rash papular; Skin warm; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72222~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARCEL~MERCK & CO. INC.~1145F~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0273755	03/09/2007	PA	68.0	68		F	03/09/2007	I am a very healthy person, 2 months after I got the flu shot I got Herpes Zoster {shingles} on my face involving my eye. I believe that the flu shot was the catalyst that activated the zoster.I noticed that many older persons were being treated at the same time for the same thing while at my eye doctor's office. I don't know if the fact that most had also probably had the flu shot because of there age is coincidental or if the flu shot is involved.There are many people on the web that say that they got zoster after receiving the flu shot. I think that you should check it out.				Y					N	11/09/2006	01/24/2007	76		PVT	UNK	spiriva	none	emphysema			1						1	Herpes zoster; Herpes zoster ophthalmic	FLUX~UNKNOWN MANUFACTURER~000~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0273782	03/12/2007	VA	38.0	38		M	03/12/2007	Atopic dermatits and myositis in right arm at vaccination site									U	02/27/2007	03/05/2007	6		MIL	UNK	none	r external ear infection	none			1						1	Dermatitis atopic; Injection site reaction; Myositis	DTAP~UNKNOWN MANUFACTURER~~UNK~IM~RA~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~IM~LA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0273802	03/12/2007	NY	16.0	16		M	03/07/2007	Encephalitis, Seizures hospitalized at medical center, including ICU stay. 3/23/07 Received medical records from hospital which reveal patient experienced vomiting, fatigue, weakness, facial & chest petechial rash.  Patient lived in dormitory at school, home on weekends.  Seen by PCP who sent to outlying ER for w/u.  While in ER patient had seizure & was admitted to ICU.  Had another seizure in ICU & was transferred to higher level of care on 12/7/06-1/5/07.  On admit exam showed not responsive to commands but opening eyes to voice & pain.  DTRs absent.  +Babinski on R & - on L.  Consults by neuro, ID & neurosurg.  Tx w/antibiotics, antivirals, multi antiseizure meds & IVIG.  Experienced rash & all meds d/c.  Then seizures recurred & antiseizure med restarted x 1.  Developed mild bone marrow suppression thought to be due to antiviral med.  Patient began to respond on 12/20 & gradually improved to almose full function by d/c on 1/5 to outpatient rehab. FINAL DX: Encephalitis.			Y		Y	30			Y	11/17/2006	12/01/2006	14	LABS: CT showed subarachnoid posterior fosse cyst.  CSF 475 RBC, glucose 67, protein 34, WBC 1, poly 13, mono12, lymph 75 Blood CMV IgG & IgM +; mycoplasma IgG +.  Resp c/s neg.  MRI was WNL.  Initial encephalitis studies were +.  EEG showed frontotemporal seizure activity for approx 10-11 days after admission	PVT	UNK		NONE				1						1	Convulsion; Encephalitis; Intensive care	FLU3~SANOFI PASTEUR~U2260AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0271927	03/13/2007	CT	0.54	0	.5	M	03/12/2007	Information has been received concerning a 6 month old male with eczema and recurrent wheezing and a history of respiratory syncytial virus bronchiolitis who on 29-JAN-2007 was vaccinated PO with a second dose of Rotateq (Lot #654663/0942F). Concomitant vaccination administered that day included an IM second dose of Pediarix (lot #AC21B097AB), an IM first dose of Fluzone (lot # UT2191KA) and an IM second dose of Prevnar (lot B08691A). There were no other medications. The patient developed explosive diarrhea and emesis shortly after the vaccine was given. On 06-FEB-2007 the patient was admitted to the hospital for worsening vomiting. On the morning of 07-FEB-2007 he was found to have intussusception. A stool culture and viral studies were to be done. An ultrasound showed ileocolic intussusception and the patient was transferred. The patient's outcome was not known. The patient's adverse events were considered to be life threatening. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements and was released by the regulatory agency. Follow-up information received on 05-MAR-2007 indicated that the patient had a barium enema. Additional information has been requested.			Y	Y	Y	0	Y		U	01/29/2007			Ultrasound 02/07/07 ileocolic intussusception.	OTH	OTH		Eczema, wheezing	Respiratory syncytial virus bronchiolitis.		WAES0702USA03318	1						3	Diarrhoea; Intussusception; Ultrasound scan; Vomiting; Culture stool; Diarrhoea; Intussusception; Ultrasound scan abnormal; Vomiting; Barium enema; Diarrhoea; Intussusception; Ultrasound scan; Ultrasound scan abnormal; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~ac21b097ab~3~IM~UN~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~ut2191ka~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~b08691a~3~IM~UN~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0942F~3~PO~MO~ROTAVIRUS (ROTATEQ)~1|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B097AB~2~IM~~DTAP + HEPB + IPV (PEDIARIX)~2|FLU3~SANOFI PASTEUR~UT2191K~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|PNC~PFIZER\WYETH~B08691A~2~IM~~PNEUMO (PREVNAR)~2|RV5~MERCK & CO. INC.~0942F~2~PO~MO~ROTAVIRUS (ROTATEQ)~2|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B097AB~2~IM~~DTAP + HEPB + IPV (PEDIARIX)~3|FLU3~SANOFI PASTEUR~UT2191KA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~3|PNC~PFIZER\WYETH~B08691A~2~IM~~PNEUMO (PREVNAR)~3|RV5~MERCK & CO. INC.~0942F~2~PO~MO~ROTAVIRUS (ROTATEQ)~3	USA	Life Threatening,Hospitalisation	Influenza
0273857	03/13/2007	WA	3.0	3		F	02/28/2007	Left arm began swelling, warm to touch and red at injection site. Recheck on 2/28 - swelling and redness have completely resolved. No pain.									Y	02/21/2007	02/22/2007	1		UNK	PUB	None	None		swelling~Vaccine not specified (no brand name)~~4.00~In Sibling		1						1	Injection site erythema; Oedema peripheral; Skin warm	DTAP~SANOFI PASTEUR~C2521AA~4~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2281AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB139BA~1~IM~LA~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~B081074E~4~IM~RA~PNEUMO (PREVNAR)~1	USA		Influenza
0273858	03/13/2007	TX	64.0	64		F		One week after TD vaccination left arm began to swell - extended down arm to hand and up over shoulder - 2 wks went to M.D. received steroid injection - continued to spread - contacted office reported 2-22-07 - Encourage to return to M.D. - rash had spread around breast. MD Rx for medicine (pill) for itching and continued use of hydrocortisone cream. No report of diagnosis of injection.				Y						01/12/2007	01/19/2007	7		PVT	PVT	Only tissue removed Tamoxifen was small piece from right site - No mastectomy or lymph nodes	NONE				1						1	Oedema peripheral; Pruritus; Rash	FLU3~SANOFI PASTEUR~U2245AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U1731BA~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0273864	03/13/2007	MI	4.67	0	.6	F	03/07/2007	Child received immunization about 2 pm at clinic.  Mom reported child had diarrhea about 1 hour after the shot; cried for 2 hour and had temp of 105 deg. Mom reports she called the local ER and she was told child was having reaction to flu shot and never to get anymore. Child did not go to physician or to the ER. Mom reports she did give pt oral Tylenol.									Y	02/07/2006	02/07/2006	0		PUB	PUB		asthma	asthma			1						1	Body temperature increased; Diarrhoea	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~~3~IM~~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~~3~IM~~PNEUMO (PREVNAR)~1	USA		Influenza
0273874	03/13/2007	OH	1.0	1	.0	F	03/12/2007	Prolonged febrile seizure > 30 minutes lifesquad to ER, seizures meds, infant transferred to Children's ER, admitted to ICU.  03/26/2007 MR received for a 2 day hospital stay following transfer from local facility to pediatric hospital.  Infant had a 1 day hx. of tactile fever, mild congestion, and decreased activity.  Pt. noted by mom to have whole body shaking of generalized tonic/clonic type. Seizure activity >30 minutes. Initially treated at primary facility with Diastat and Ativan with subsequent apnea resulting in intubation .   PE:  ETT in place.  Skin slightly mottled. Cool extremities. Intermittant 4 extremity twitches and shivers.  Babinski decreased. Otherwise WNL.  Txd with antibiotics, NS fluid bolus for decreased perfusion with good results, Phosphenytoin for seizure control.  No further seizure activity observed.  Extubated and weaned to RA without difficulty. Initial Assessment:  Febrile Seizure likely 2' to MMR vaccine. Final DX: New Onset Seizure.				Y	Y	2			Y	02/20/2007	03/01/2007	9	CBC, LP,Urine, CT scan (-), CPR (-). Labs and Diagnostics:  Head CT unremarkable.  CBC, UA, CSF studies all reassuring.	PVT	UNK	Meds: None.		NONE. PMH: None. No previous seizure hx. Allergies: None.			1						1	Computerised tomogram normal; Febrile convulsion; Full blood count; Lumbar puncture; Urine analysis normal	FLU3~SANOFI PASTEUR~U2281~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~1213F~1~IM~LL~HEP A (HAVRIX)~1|MMRV~MERCK & CO. INC.~1524F~1~SC~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B36256~1~IM~LL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0273883	03/13/2007	OH	1.19	1	.2	M	03/13/2007	Client in for well child visit and did have 2nd flu vaccine (first administered on 1/9/07 by RN using lot #U2175HA). The lot number for the 2nd flu shot was UT2176BA. The 2nd flu shot was administered in the am before 12pm. Accordind to Mother, the child awoke from sleep at about 10:30pm with altered LOC. The child was also starting to seize with jerking movements. At the time the child awoke, the Mother called 911 and temp 101. When the ambulance arrived approx. 30 min. after the call, the Mother states the temp was 103. On the day that the 2nd flu shot was administered, the child was also ill with an acute otitis media and anemia and was being treated with omnicef 125 1 1/4 tsp /day and ferisol drops BID. Child in today for well child visit and appears well. Advised Mother to discuss incident with her child's physician before getting another flu shot for her child in the future.  03/23/2007 MR received for an ED visit for parental report of first seizure at home on the day of Flu vax.  Child had been running a fever.  His eyes rolled back and then began shaking all over. This lasted appox. 1 minute after which he awoke and took a bottle.  PE: Crying and fretful.  Temp=103'F. Skin feels hot.  TMs red bilaterally.  Otherwise WNL.  TXd with Tylenol and Motrin with fever reduction.  DC home. Discharge DX:  Febrile Seizure.				Y					Y	02/27/2007	02/27/2007	0	n/a. Labs and Diagnostics:  CBC with WBCs of 11.6(58%polys, 20%bands and 19% lymphs). Chem WNL except K+ of 6.2.	UNK	UNK	omnicef, ferisol. Meds: Motrin, Omnicef, Ferrous Sulfate	left acute otits media, anemia	PMH: Frequent ear infections, currently on Omnicef for one.  Low Iron levels.  Allergies:  NKA.	n/a~ ()~~0.00~Patient|n/a~ ()~~0.00~Sibling|n/a~ ()~~0.00~Sibling		1						1	Body temperature increased; Convulsion; Depressed level of consciousness; Dyskinesia; Pyrexia	FLU3~SANOFI PASTEUR~UT2176BA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0273893	03/13/2007	WA	0.7	0	.7	F	03/13/2007	Reported by caregiver that child had an episode of body shivering about five times and than head would hang down.  This occurred over about two minutes.  The child returned to normal activity right after shivering episode.  This happened at about 1:00 on March 12, 2007.									Y	03/12/2007	03/12/2007	0		PUB	PUB	Albuterol 2.5 mg via neb q4-6hr prn	URI, Eczema				1						1	Chills; Posture abnormal	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B090AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2201EA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF016AA~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B08675F~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0270145	03/14/2007	NY	19.0	19		F	12/18/2006	Initial report received from a health care professional on 12 December 2006. A 19 year old, female patient (with a medical history of no known allergies) developed a flushed, red and itchy face, 2 days after she received Fluzone (lot number U2240AA) intramuscularly in the left deltoid, Menactra (lot number U2159AA) intramuscularly in the right deltoid and Gardasil (lot number unknown) on 20 November 2006. On 23 November 2006, the patient called to report red spots on hands. The patient did not have any illness at the time of vaccination. She was treated with Benadryl. She was not seen at the doctors office and has moved. It was reported that she recovered.									Y	11/20/2006	11/22/2006	2		PVT	UNK	Nevacor, Birth control pills, Celexa, Clonitin		NONE		200603463	1						3	Erythema; Flushing; Pruritus; Erythema; Flushing; Hypersensitivity; Pruritus; Skin burning sensation; Erythema; Flushing; Pruritus; Rash macular	FLU3~SANOFI PASTEUR~U2240A~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~~1~~UN~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2159A~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HPV4~MERCK & CO. INC.~0954F~1~IM~~HPV (GARDASIL)~2|MNQ~SANOFI PASTEUR~~UNK~~~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|FLU3~SANOFI PASTEUR~U2240AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|HPV4~MERCK & CO. INC.~~1~~~HPV (GARDASIL)~3|MNQ~SANOFI PASTEUR~U2159AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~3	USA		Influenza
0273926	03/14/2007	TX	10.0	9		F	03/09/2007	After receiving the vaccine in fall/winter of 06, she contracted flu strain A in February of 2007 and flu strain B in March of 2007. The pediatrician and I believe the immunization to be a placebo or false immunization.									N	10/11/2006	02/01/2007	113	Flu lab tests in Feb and March	OTH	PVT	NONE	NONE	Allergies to mold, dust.			1						1	Influenza; Influenza serology; Poor quality drug administered; Vaccination failure	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71033~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0273985	03/14/2007	MI	1.1	1	.1	M	03/14/2007	Patient given Rototeq, too old. No adverse events reported.									Y	02/19/2007			NA	PUB	PUB	AMOXICILLIN 250MG/5ML DISPENSE 10MG PO BID X 10 DAYS	S/P EAR INFECTION	2/17/07 DX WITH EAR INFECTION IN ER. TOLD TO HAVE IMMUNIZATIONS AT THAT TIME.			1						1	Inappropriate schedule of drug administration; No adverse effect; Inappropriate schedule of drug administration	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B010AA~2~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2307AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1009R~2~IM~LL~HIB (PEDVAXHIB)~1|MMRV~MERCK & CO. INC.~0971F~1~SC~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08684F~2~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~~1~PO~MO~ROTAVIRUS (ROTATEQ)~2	USA		Influenza
0273991	03/15/2007	PR	50.0	50		M		Allergies, arthritis, balance problems, blood pressure varies, infection fungal, sleep insomnia, sleep problems, memory short terms memory loss, pain leg, pain lower back, arthritic pain in feet like electric shock, pain neck, walking difficulty, urinary frequency.03/27/07-records received from provider  DX:hyperlipidemia health maintenance impaired fasting glucose dental disorder obesity osteoarthrosis involving the knee disorders of bursae and tendons in shoulder region elevated liver function test HX:chronic cervical and lower back pain, recently had a right knee arthroscopy for meniscus tear 11/26/06. feels that epidural block administered during surgery has worsened his low back pain and persists with cervical pain. Sustained knee injury in Iraq.				Y				Y	Y	01/22/2003	07/09/2004	534		MIL	MIL			NONE			1						1	Amnesia; Arthralgia; Arthritis; Back pain; Balance disorder; Blood pressure fluctuation; Fungal infection; Gait disturbance; Hypersensitivity; Insomnia; Myalgia; Neck pain; Pain in extremity; Paraesthesia; Pollakiuria; Sleep disorder	ANTH~EMERGENT BIOSOLUTIONS~FAV072~7+~~~ANTHRAX (BIOTHRAX)~1|FLU3~EVANS VACCINES~765757~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~SMITHKLINE BEECHAM~1396A6~4~~~HEP B (ENGERIX-B)~1|HEPA~MERCK & CO. INC.~~3~~~HEP A (VAQTA)~1	USA	Disabling	Influenza
0273998	03/15/2007	FL	22.0	22		M	03/10/2007	Itching, hives in patient given 80mg Benadryl oral at 1206.									Y	03/10/2007	03/10/2007	0		OTH	OTH			Drug allergy to Levaquin			1						1	Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA2431317~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0274019	03/15/2007	WA	46.0	46		F	02/27/2007	2 days post flu vaccine hives/generalized itching. No SOB.									Y	02/19/2007	02/21/2007	2		PUB	UNK			Allergic to cats			1						1	Pruritus generalised; Urticaria	FLU3~SANOFI PASTEUR~U2281AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0274051	03/15/2007	CA	0.51	0	.5	M	03/15/2007	Pt received 3rd dose of Pediarix, Prevnar and also flu and Rotateq on 3/12/07. Pt developed difficulty breathing, shaking and high fever (per parents). 4/20/07 Received ER medical records from hospital which reveal patient experienced fever 103.7, cough, nasal congestion, runny nose, pulling at ears, vomiting x1 post tussive & shivering on 3/13/07 day after vax.  Ear exam was WNL.  D/C to home on antipyrectics. FINAL DX: Fever, likely secondary to immunizations.				Y					Y	03/12/2007	03/13/2007	1		PUB	UNK	NONE	NONE	PMH: ear infection 1 mo prior to ER.  Second hand smoke exposure from both parents.  Allergy amoxicillin.			1						1	Dyspnoea; Pyrexia; Tremor	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~GSKAC21B084BA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLUX~UNKNOWN MANUFACTURER~AVPU2220BB~1~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PNC~PFIZER\WYETH~WYEB08684F~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0849F~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0273206	03/16/2007	UT	19.0	19		F	03/14/2007	Information has been received from a consumer concerning her daughter, a 19 year old female with a history of a seizure response to pertussis vaccine as an infant, who on 11-OCT-2006 was vaccinated with the first dose of Gardasil and on 22-JAN-2007 was vaccinated with the second dose of Gardasil. The mother reported that her daughter had no adverse experiences with that vaccination. Concomitant suspect therapy included influenza virus vaccine (unspecified), also administered on 22-JAN-2007. On 29-JAN-2007 the mother stated that her daughter experienced severe systemic arthritic response, and further explained, she woke up with severe joint pain, severe fatigue, headaches and a red, blotchy facial rash. The mother reported that her daughter had multiple lab work performed, however specific tests or results were not provided. At the time of this report, the patient had not recovered. Additional information has been requested.				Y					N	01/22/2007	01/22/2007	0	seum ANA, 01/29/07, negative; serum creatinine kinase, 01/29/07, negative	OTH	OTH	Unknown	Allergy to vaccine	Convulsion		WAES0702USA04702	1						2	Fatigue; Headache; Muscular weakness; Myalgia; Vaccination complication; Antinuclear antibody negative; Arthralgia; Blood creatinine normal; Erythema; Fatigue; Headache; Rash; Rash macular	FLU3~SANOFI PASTEUR~U2177AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0688F~2~IM~LA~HPV (GARDASIL)~1|HPV4~MERCK & CO. INC.~0688F~2~~UN~HPV (GARDASIL)~2	USA	Emergency room visit	Influenza
0274082	03/16/2007	TX	40.0	39		F	03/16/2007	Could not stand, could not understand, memory loss, ten days later had massive seizure.				Y	Y	0			Y	02/09/2007	02/10/2007	1	UNK	PUB	PVT		UNK	UNK			1						1	Amnesia; Cognitive disorder; Convulsion; Dysstasia	FLU3~SANOFI PASTEUR~U2283AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0274096	03/16/2007	NC	1.11	1	.1	F	03/02/2007	Rash slightly raised papular, mildly red, not of a sandpaper quality, scattered but bit confluent over trunk; present but not enhanced in diaper area. Rash is fine on face and proximal extremities, rash is thick and confluent in the area surrounding right thigh. She has tender nodules at the injection sites. The rash is thickest around the site on her lower right leg and extends to upper right leg. Continue use of Benadryl and Tylenol. Avoid Pertussis vaccine in future.				Y					Y	12/01/2006	12/03/2006	2	NONE	PVT	PUB	Tylenol	NONE	NONE			1						1	Erythema; Injection site nodule; Injection site rash; Rash; Rash papular	DTAP~SANOFI PASTEUR~U1985BA~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2247AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0654F~1~IM~LL~HEP A (VAQTA)~1|HIBV~MERCK & CO. INC.~0403F~3~IM~RL~HIB (PEDVAXHIB)~1	USA	Emergency room visit	Influenza
0274128	03/16/2007		16.0			F	03/14/2007	Information has been received from a pharmacy student concerning a 16 year old female who on December 2006, was vaccinated IM with a first 0.5 ml dose of HPV. Concomitant therapy included given the same day included a dose of influenza and a dose of Menactra. Seven days after vaccination, the patient experienced headache, nausea, vomiting and diarrhea. The patient was treated with Nexium and Phenergan tablets/suppositories. On 13-DEC-2006 the patient experienced a sinus infection and was placed on a Z-pack. All symptoms resolved except the headache. On 19-JAN-2007, the patient was seen by a neurologist and was placed on Prednisone for 10 days. He also ordered Tazepam to help her sleep since the headaches were keeping her awake and Endocet for the headache pain. The patient has missed a lot of school and is sedentary. She was also complaining of tingling in the hands and legs. The following tests have come back negative: CAT scan, MRI, Lyme and mono workup. At the time of this report, the patient had not recovered from tingling in the hands and legs and headache. No product quality complaint as involved. Additional information has been requested. 04/10/07-records received from neurologists for DOS 2/6/07-DX: muscular headaches with some functional overlay. Doubt side effect of Gardasil. C/O headaches, back pain, GI problems recent urinary symptoms, difficulty urinating and dysuria. C/O visual symptoms including blurry vision and spots before her eyes. PE: pain in neck, pain with deep palpation of right popliteal fossa. Walks normally. 05/01/07-records received from facility for DOS 02/09-02/12/07-DC DX: Vomiting and Abdominal Pain. HX 2month of chronic somatic complaints including nausea, epigastric discomfort, diffuse soft tissue and joint pain, vomiting, periodic shortness of breath and recent urinary symptoms. Labs, liver enzymes elevated in context of multiple Tylenol usage as an outpatient due to her pain.Hospital course included discontinuance of Tylenol and Percocet. LFTs steadily trended downward and she did not have pain or vomiting.				Y	Y	3			N	12/01/2006	12/08/2006	7	computed axial, 12/06; magnetic resonance, 12/06 records received 5/1/07-MRI negative, lab work normal. CT head and MRI of head negative. Normal abdominal ultrasound. Doppler normal of kidneys, normal upper GI series. negative lyme, negative beta HCG. Normal stool cultures. Strep culture negative.	OTH	OTH	UNKNOWN		UNKNOWN		WAES0702USA00866	1						1	Bacterial test negative; Computerised tomogram normal; Decreased activity; Diarrhoea; Headache; Mononucleosis heterophile test negative; Nausea; Nuclear magnetic resonance imaging normal; Paraesthesia; Sinusitis; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~1~IM~UN~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Hospitalisation	Influenza
0274148	03/16/2007	NC	53.0	53		M	03/16/2007	Fever 103.6F, Axillary lymph nodes swollen, Feels like a baseball in armpit. Headache. Alternate moist heat and cold compress. Cephalaxin.									Y	11/13/2006	11/14/2006	1	None	PVT	PVT	Diovan, HCTZ, Niaspan, Aspirin, Plavix, Zetia, Coreg, Amyryl,Caduet, Lantus, NTG, Ultracet, Avandia, Metformin, Humalog.	Routine office visit for health maintenance.				1						1	Cold compress therapy; Headache; Heat therapy; Lymphadenopathy; Pyrexia; Headache; Lymphadenopathy; Pyrexia	PPV~MERCK & CO. INC.~0959F~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA234AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~2|PPV~MERCK & CO. INC.~0959F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0275058	03/16/2007	OH	66.0	66		F	03/14/2007	Information has been received from a health professional concerning a 66 year old female physician with no allergies or medical history on 10-NOV-2006 was vaccinated IM in the left deltoid with an 0.65 ml dose of Zostavax (lot # 652936/0981F). Concomitant therapy included ULTRAM. Twenty-four hours later, on 11-NOV-2006, the patient developed a fever of 101 degrees. Her left arm and deltoid injection site injection site became red, swollen, and hot to the touch. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. The patient recovered on 12-NOV-2006. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2007. Initial information has been received from a medical assistant concerning a 66 year old female physician with no allergies or medical history who on 10-NOV-2006 was vaccinated SC (previously reported as IM) in the right (previously reported as left) deltoid with an 0.65 ml dose of ZOSTAVAX (lot # 652936/0981F). Additional information received from the physician indicated that the reaction was a reaction to the influenza virus vaccine (unspecified) (manufacturer unknown) (lot # 71829) and not ZOSTAVAX (Merck) (lot # 652936/0981F). No further information was reported. Additional information is not expected.				Y					Y	11/10/2006	11/10/2006	0	Body temp 11/11/06 101	PVT	OTH	ULTRAM		None; Colonoscopy		WAES0702USA03871	1						1	Body temperature increased; Erythema; Injection site erythema; Injection site swelling; Injection site warmth; Oedema peripheral; Pyrexia; Skin warm	FLUX~UNKNOWN MANUFACTURER~71829~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~0981F~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0273985	03/19/2007	MI	1.09	1	.1	M	03/14/2007	Information has been received from a registered nurse concerning a 13 month old patient who on 19-FEB-2007 was vaccinated with a 2 mL oral first dose of Rotateq. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information has been requested.									U	02/19/2007	02/19/2007	0	Unknown	OTH	OTH	Unknown		Unknown		WAES0702USA03604	1						2	Inappropriate schedule of drug administration; No adverse effect; Inappropriate schedule of drug administration	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B010AA~2~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2307AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1009R~2~IM~LL~HIB (PEDVAXHIB)~1|MMRV~MERCK & CO. INC.~0971F~1~SC~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08684F~2~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~~1~PO~MO~ROTAVIRUS (ROTATEQ)~2	USA		Influenza
0274170	03/19/2007	NY	23.0			F		On day 6th after 1st dose of HPV and Influenza vaccine given at health center, forearms, hands, palms maculopapular erythematous rash that became heavy and spread to entire body. Patient had been seen by 2 dermatologist, patches/hives last for 1 1/2 weeks. Required treatment with oral steroids (Medrol pack). No other current illness such as fever, headache, arthralgia, arthritis or myalgia. Reaction developed despite oral Claritin daily.				Y					Y					PUB	UNK			Hay fever			1						1	Rash erythematous; Rash maculo-papular; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPVX~UNKNOWN MANUFACTURER~~UNK~~~HPV (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0274239	03/19/2007	MA	47.0	47		F	03/12/2007	Demyelination - numbness and tingling from the breastbone down hips and pelvis into both legs all the way down to feet - pins and needles. Extreme fatigue, visual changes. Increase in migraine headaches - IV Prednisolone 3000 mg ---> home taper dose.			Y	Y	Y	10	Y			11/10/2006	12/28/2006	48	Blood work, MRI of brain, C spine, T and L S spine, Lumbar puncture.	PVT	PUB		NONE				1						1	Blood test; Condition aggravated; Demyelination; Fatigue; Hypoaesthesia; Lumbar puncture; Migraine; Nuclear magnetic resonance imaging brain; Paraesthesia; Visual acuity reduced	FLU3~SANOFI PASTEUR~U2215AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0274241	03/19/2007	TN	52.0	52		F	03/07/2007	Upper right arm-shoulder to elbow-red and warm to touch. Slight swelling upper right arm also.				Y					Y	02/28/2007	03/05/2007	5		PUB	PUB	On numerous meds for other health problems	NONE	allergic to Sudafed, Doxycycline/COPD, Hypothyroidism, Hyperlipidemia		TN07003	1						1	Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U2292AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB367AA~1~IM~LA~HEP B (ENGERIX-B)~1|TDAP~SANOFI PASTEUR~C2689AA~UNK~IM~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0274242	03/19/2007	NC	1.5	1	.5	M	03/14/2007	On 1/30/06, pt had a small red dot like a pimple on his right cheek. Increased in size to 1 cm x 1 1/2 cm hyperpigmented macule in result. Otitis concurrently treated with Amoxicillin and Bactroban. Child had frequent URIs and Otitis Media 10-06 through 1-07.									Y	12/01/2006	12/31/2006	30	NONE	PVT	PVT	NONE	NONE	Chronic Otitis Media, URI			1						1	Rash macular; Skin discolouration	DTAP~SANOFI PASTEUR~U1985BA~4~~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT2176CA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~U654F~1~~LL~HEP A (VAQTA)~1	USA		Influenza
0274249	03/19/2007	KS	37.0	37		M	03/06/2007	Right deltoid pain and weakness following the shot									Y	11/01/2006	11/01/2006	0	MRI	PVT	PVT	NONE	NONE	NONE			1						1	Asthenia; Myalgia; Nuclear magnetic resonance imaging	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601111~1~~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0274355	03/19/2007	CA	1.36	1	.4	M	02/22/2007	Deltoid swollen, erythematous warm to touch and minimum tender to touch.									U	02/22/2007	02/22/2007	0		PUB	PUB					CA07007	1						1	Erythema; Oedema peripheral; Pain of skin; Skin warm	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B042BA~4~~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~Y2187AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0274356	03/19/2007	CA	13.0	13		F	02/09/2007	Broke out in hives within 24 hours of receiving HPV and Flu vaccine.									U	01/23/2007	01/23/2007	0		PVT	OTH			NONE			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2176FA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0954F~1~IM~~HPV (GARDASIL)~1	USA		Influenza
0274357	03/19/2007	MN	44.0			F		20 minutes after I was given the Influenza shot I was feeling very dizzy and felt like passing out, my heart rate elevated to 164/87 and my normal is  104/62. I was shaking all over and was taken to ER. I was given Epinephrine and hooked up to a heart monitor because my heart was skipping a beat. Went home 3 hours later still could not breathe well and was very dizzy. Went to ER again that night and was told they could not find anything and to continue to take Benadryl this continued for the next month and have been to ER 4 times total and to the clinic, Neurologist and Allergy specialist several times. I was out of work for 3 months because of trouble breathing, dizziness and weakness of arms and legs. I was given Prozac. Zoloft. Ativan, and Allegra during this time stopped taking medications and went to work on 2/16. 3/13 still not feeling like I did before having the shot. Still feeling light headed and dizzy.				Y									All test were done at medical center reported, doctors name reported for allergy specialists.	UNK	UNK		NO KNOWN ILLNESS				1						1	Dizziness; Dyspnoea; Heart rate increased; Muscular weakness; Tremor	FLU3~SANOFI PASTEUR~U2212AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0274866	03/19/2007	TX	0.53	0	.5	F	03/14/2007	Information has been received from a physician concerning a patient who was vaccinated with the third dose of Rotateq. The physician reported that the patient subsequently experienced a fever of 104 degrees. Unspecified medical attention was sought. The patient's fever subsequently resolved. Additional information has been requested. 06/01/2007 Information has been received from a physician concerning a 6-month-old female with no medical history who on 08-JAN-2007, at 1100, was vaccinated PO with the third dose of ROTATEQ (Lot #655174/0848P). Concomitant vaccinations adminstered on that same day and time included the third IM dose in the right thigh of PREVNAR (Lot #B08653H), the third dose in the left thigh of TRIPEDIA (Lot #U1813BA) and the first IM dose in the left thigh of FLUZONE (Lot #U2174DA). There was no illness at the time of vaccination. The physician reported that on 15-JAN-2007, the patient vomited x 1 and experienced a fever of 102-104 degrees. No other symptoms were reported. Unspecified medical attention was sought. No laboratory/diagnosic tests were performed. On 18-JAN-2007, the patient recovered. Additional information has been requested.				Y					Y	01/08/2007	01/15/2007	7	Body temp, 01/15/07, 102-104	PVT	PVT	Unknown		Unknown		WAES0702USA01363	1						1	Body temperature increased; Pyrexia; Vomiting	DTAP~SANOFI PASTEUR~U1813BA~3~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2174DA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08653H~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0848P~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0273691	03/20/2007	NY	12.0	12		F	03/19/2007	Information has been received from a physician concerning an adolescent female (demographics not provided) who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not provided). Concomitant therapy included an unspecified anti malaria medication. Subsequently, on an unspecified date  a few days later the patient had a seizure. It was reported by the physician that at the time the patient has a series of tests (NOS) but no diagnosis was found. On another unspecified date the patient received the second dose of Gardasil (lot # not provided) and sixteen days post vaccination, on an unspecified date the patient had seizure. The patient sought unspecified medical attention. The physician reported that it was not known if additional test were completed. The physician reported that the patient had recovered from the seizures. Upon internal medical review, the seizures were felt to be other medical events. Additional information has been requested.				Y					Y	12/11/2006	12/21/2006	10		OTH	OTH	Therapy unspecified		UNK		WAES0703USA01477	1						2	Electroencephalogram; Nuclear magnetic resonance imaging; Convulsion; Vaccine positive rechallenge; Convulsion; Electroencephalogram normal; Gaze palsy; Laboratory test; Loss of consciousness; Nuclear magnetic resonance imaging normal	FLU3~SANOFI PASTEUR~u2166mA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1163F~1~IM~LA~HPV (GARDASIL)~1|HPV4~MERCK & CO. INC.~~2~UN~UN~HPV (GARDASIL)~2|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~3|HPV4~MERCK & CO. INC.~1163F~1~IM~RA~HPV (GARDASIL)~3	USA	Emergency room visit	Influenza
0274342	03/20/2007	OR	22.0			F	03/19/2007	Left arm flushing and generalized itching without rash.									Y	03/08/2007	03/09/2007	1	NONE	PVT	PVT	Dilantin 100 mg 3 daily, Tylenol 325 prn, Zyrtec 10mg 1 daily	NONE	Seizures			1						1	Flushing; Pruritus generalised	FLU3~SANOFI PASTEUR~U2167PA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1137F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0274363	03/20/2007	NY	0.52	0	.5	F	03/19/2007	Information has been received from a physician concerning a 7 month old female, with no medical history and no allergies, who was vaccinated with an oral first, second, and third dose of Rotavirus on 11-AUG-2006, 15-NOV-2006, and 16-JAN-2007, respectively. Concomitant vaccines administered on 16-JAN-2007 included a dose of Prevnar, a dose of Influenza (unspecified) and a dose of Pediarix. On 05-Mar-2007 the patient experienced lethargy, abdominal pain, bloody stool, and a prolapsed rectum. The patient was hospitalised for 2 nights. The patient was given a hydrolic enema. No surgery was needed. Subsequent, the patient completely recovered. No product quality complaint was involved. Additional information has been requested.				Y	Y	2			Y	01/16/2007	03/05/2007	48	blood culture, 03/05/07; complete blood cell, 03/05/07	OTH	OTH			NONE		WAES0703USA01100	1						1	Abdominal pain; Blood culture; Enema administration; Full blood count; Haematochezia; Lethargy; Rectal prolapse	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B084CA~UNK~~~DTAP + HEPB + IPV (PEDIARIX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PNC~PFIZER\WYETH~B08646E~UNK~~~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1166F~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0274414	03/20/2007	TX	1.08	1	.1	M	03/20/2007	3-13-07 Mother took child to Hospital with complaints of high fever and swollen left thigh.  Diagnosis: Otitis Media Treatment: Amoxicillin, follow up with doctor for swelling to left thigh.  Sonogram pending.  3-20-07 Mother walked in stating child unable to ambulate since immunizations administered 2-27-07. Non-tender nickel size nodule noted to left mid thigh. Mother was provided with spanish education regarding the potential adverse effects from childhood immunizations, including exaggerated localized reaction, and sterile abcess. Patient demonstrated ambulation without any hesitation, guarding, jor limited mobility.Mother was instructed to follow thru with Hospital referral with doctor to evaluate swelling of left thigh. Child evaluated by PA-C. He identified mass Lt thigh post vaccination most likely represents a sterile abcess or hematoma.  She was referred to doctor as recommended initally by Hospital.  Mom also advised that this could resolve on its own.  R.N.				Y					Y	02/27/2007	02/27/2007	0	Per Mother's history sonogram of left thing.	UNK	UNK		NONE	NONE IDENTIFIED			1						1	Abasia; Abscess; Haematoma; Injection site nodule; Mass; Mobility decreased; Oedema peripheral; Otitis media; Pyrexia; Ultrasound scan	DTAP~SANOFI PASTEUR~U1985BA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2283AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1213F~1~IM~LL~HEP A (VAQTA)~1|HIBV~SANOFI PASTEUR~UE990AA~4~IM~LL~HIB (ACTHIB)~1|MMRV~UNKNOWN MANUFACTURER~0150U~1~ID~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (NO BRAND NAME)~1|PNC~PFIZER\WYETH~B08674C~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0274439	03/21/2007	CA	53.0	53		F	03/16/2007	Initial report received on 17 January 2007 from the patient. A female patient (date of birth not reported), who has no concurrent illnesses or pre existing medical conditions, but who had tested positive for egg allergy (date of testing not reported), had received a right arm dose of Fluzone on 08 November 2006. The lot number, route and site of administration was not reported. Three days post-immunization, the patient had chills, numbness, tingling, and shooting pain in her arms that spread to all four extremities over the next month. At an unspecified amount of time later, the patient was evaluated by two neurologists at a hospital (contact information for the hospital was provided) and all tests were normal. Diagnostic testing included a Brain scan, and ANA test that were normal. The patient had not received any other vaccinations within four weeks of the vaccination on 08 November 2006. At the time of this report, the patient had not recovered. Follow-up information received on 20 February 2007. There was no additional information . Follow up information received on 15 March 2007 from the patient. The patient reported that she still had sharp pains in my bones and the numbness has continued now for four months. treatments received and diagnostic testings performed were not reported. Due to this new information, the seriousness of this case has been upgraded to serious.				Y					N	11/08/2006	11/11/2006	3		OTH	PVT			The patient had no concurrent illnesses at the time of the vaccination on 08 November 2006. The patient had no pre-existing medical history, but tested positive for egg allergy (date of testing was not reported). The patient had not received any vaccinations within four weeks of the vaccination on 08 November 2006.		200700138	1						1	Antinuclear antibody negative; Bone pain; Chills; Hypoaesthesia; Neurological examination normal; Pain; Pain in extremity; Paraesthesia	FLU3~SANOFI PASTEUR~~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0274447	03/21/2007	CA	81.0	81		M	03/16/2007	Pt was admitted on 10/29/06 for febrile illness, fever of 104 with chills. Pt reported receiving flu shot about 10 days prior. Febrile illness was attributed to flu shot vs viral illness. Pt improved and discharged on 11/1/06. Please note patient had 2nd admission 11/8/07 for increased chills, fever this time attributed to pancreatitis with elevated lipase (27,000) with possible viral etiology. Please note with first admission throat culture, urine culture, chest xray and infection at endartectomy site (performed 10/9/06) were all negative. Also there is no further information available on the flu shot, unclear where received or lot #'s. Outpatient chart was checked, no record of administration was found in OPP chart.  4/27/07 Received medicalrecords from hospital which reveal patient experienced endarterectomy of right carotid artery on 10/9/06, day of vax.  On 10/29/06-11/1/06 was admittted to hospital for fever & chills.  Temp in ER was 104.  Tx w/IV antibiotics FINAL DX: febrile illness, possibly reaction to flu shot vs viral.					Y	3			Y	10/09/2006	10/29/2006	20	WBC shift LABS: initial CXR was WNL, repeat cxr WNL. WBC w/left shift. blood c/s.  Throat c/s neg. Urine c/s neg. CT of neck done to r/o source of infection at surgical site.	UNK	UNK		Post endactrectomy	Pen rash, COPD, Asthma, Hypothyroidism, GERD, Hypertension.  PMH: HTN, COPD, hypercholesterolemia, hypothyroidism, chronic renal insufficiency, GERD. Recent endarderectomy.  Allergic PCN.			1						1	Chest X-ray normal; Chills; Culture negative; Culture urine negative; Lipase increased; Pancreatitis; Pyrexia; Viral infection; White blood cell count	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0274458	03/21/2007	NY	0.64	0	.6	F	03/15/2007	Fever, swelling lump over both thigh. Redness at right thigh was seen on 3/13/07. Temp 104F. Tylenol 0.6cc at 9:28am.				Y					Y	03/09/2007	03/11/2007	2	NONE	PUB	PUB						1						1	Body temperature increased; Erythema; Pyrexia; Swelling	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B066AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2201EA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0405F~3~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08675A~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0274462	03/21/2007	CA	3.0	3		F	03/14/2007	Pt's mother states pt developed swelling and redness on left arm for 3 days, and fever. Administered Tylenol and salt compress. Non tender.									Y	02/16/2007	02/16/2007	0		PUB	UNK						1						1	Erythema; Oedema peripheral; Pyrexia	DTAP~SANOFI PASTEUR~U1965AB~2~~LA~DTAP (TRIPEDIA)~1|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B084AA~2~~LA~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2220BB~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0274512	03/22/2007	OH	68.0	68		M	03/21/2007	Information has been received from a 68 year old male consumer who on 19-NOV-2006 was vaccinated with a dose of Pneumovax 23. Concomitant therapy included influenza on 16-NOV-2006. On 20-NOV-2006 (also reported as later that evening after receiving Pneumovax 23) the patient felt delirious and stated that his wife called life support for assistance. The patient was admitted to the hospital while the physician operated on his right shoulder. According to the patient's chart, on 29-NOV-2006 the patient had surgery due to a fractured humerus. The patient stated that he was unconscious throughout the whole process and only knew what his wife had informed him. The consumer also stated that the treating physicians at the hospital could not determine why the Pneumovax 23 and influenza affected him in this way. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested.				Y	Y	0			U	11/19/2006	11/20/2006	1	UNK	OTH	OTH			Shoulder operation		WAES0703USA02765	1						1	Delirium; Humerus fracture; Loss of consciousness; Dizziness; Joint dislocation; Life support; Loss of consciousness; Mobility decreased; Neurological symptom; Pain in extremity; Speech disorder; Surgery; Upper limb fracture	PPV~MERCK & CO. INC.~~UNK~~UN~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0274524	03/22/2007		68.0	68		M	11/29/2006	He lives by himself and he has not been eating a meal since his flu shot on Friday. He did not drink any meaningful amount of liquid at home. He came to the clinic but he collapsed before he got to the check in area. His head hit the floor. He felt lightheaded while waiting to go into the room. Pe dry oral mucosa; H 131-BP 60-70; Chest clear he is able to eat and BP 120/70 with HR around 90-100 after 2 liters of iv fluid advise him to continue on po intake.  6/8/07 Received medical records from hospital (most of which were chemo or portacath records) which reveal patient experienced fever & myalgia along w/poor appetite s/p flu shot on 11/17.  Patient lives alone & had been unable to eat or drink much since 11/17.  Had productive cough of yellow sputum.  Brought to clinic by family member because he was very tired & unable to manage at home.  Patient collapsed before he got to check in area & hit his head.  He had felt lightheaded.  Treated w/IVF x 2L, felt better & was d/c to home.				Y						11/17/2006	11/20/2006	3	HGB L 12.6 g/dl; H:16/L:13; HCT L 36.3 K: 54/L:39  LABS: EKG w/o acute change.  Troponin was neg.  glu 108, CO2 20, SGOT elevated at 36.  WBC 11.11, H/H 12.6/36.3.	UNK	UNK			PMH: mets prostate cancer (undergoing chemo in 11/06), COPD, ex cocaine, tobacco & ETOH abuser (quit all 15 yrs ago), CVA, angina, SOB, edema, HTN, epilepsy.			1						1	Blood pressure; Circulatory collapse; Dizziness; Fluid replacement; Haematocrit decreased; Haemoglobin decreased; Head injury; Heart rate	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0274525	03/22/2007					U	03/01/2007	Received report of a rash on both arms, dizziness, and nausea as a result of a Fluarix vaccination. Benadryl was administered. No name or information regarding the patient was provided.										01/05/2007				UNK	UNK						1						1	Dizziness; Nausea; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA231BA~UNK~IM~~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0274526	03/22/2007	PR				U		abdomen: burning sensation; abdomen, cramps; ache: bones; blood in stool; ache: joints; ache: joints and muscles; aches: muscles; aches: whole body; acid reflux; skin acne; allergies; alpha intrusion; high cholesterol; blood dyscrasia; bursitis; amblyopia; appetite loss; arm hot to touch; heart arrythmia; autoinoculation face; loss of concentration; difficulty concentrating; trouble concentrating; constipation; leg cramps; blood pressure varies; blood pressure high; depression; dermatitis; constant diarrhea; constant fatigue; muscle fatigue; pain and fatigue; indigestion; hair loss; continuous headaches; poor tolerance for loud noises; heart palpitations; energy loss; low energy levels; exhaustion; memory difficulty; memory loss; memory bad; memory loss with dizziness; troube remembering recent information; short-term memory loss; fungal infection; disorientation; depression; confusion; joint aches; leg pain; lower back pain; right shoulder, hip and leg pain; right hip and chest pain; groin pain; back pain; knee and hip pain; lower back pain; rash; stomach pain; bone and joint pain; joint pain; muscle and joint pain; muscle pain and stiffness; seizure-like spasms; leg pain; neck pain; pelvic pain; skin itching; dry and flaky skin; abdominal pain; chest pain; charlie horse; palpitations; sores on skin; urinary frequency; sleep problems; poor tolerance for bright lights; vision problems; unable to sleep flat without medication; stomach problems; weakness; weight gain;														MIL	MIL						1						1	Abdominal pain; Acne; Alopecia; Amblyopia; Amnesia; Anorexia; Arrhythmia; Arthralgia; Asthenia; Back pain; Blood cholesterol increased; Blood disorder; Blood pressure fluctuation; Bone pain; Burning sensation; Bursitis; Chest pain; Confusional state; Constipation; Depression; Dermatitis; Diarrhoea; Disorientation; Disturbance in attention; Dry skin; Dyspepsia; Fatigue; Fungal infection; Gastrooesophageal reflux disease; Haematochezia; Headache; Hypersensitivity; Hypertension; Muscle fatigue; Muscle spasms; Musculoskeletal discomfort; Musculoskeletal pain; Musculoskeletal stiffness; Myalgia; Neck pain; Pain; Palpitations; Pelvic pain; Photophobia; Pollakiuria; Pruritus; Skin exfoliation; Skin lesion; Skin warm; Sleep disorder; Vaccination complication; Visual disturbance; Weight increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~~UNK~~~SMALLPOX (DRYVAX)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0274536	03/22/2007	PR	49.0			M		None Stated									Y					MIL	MIL						1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0274548	03/22/2007	NY	37.0	37		M	02/13/2007	was administered three vaccines in one visit: tetanus, pneumonia, and flu.  was administered at my  primary health care provider facility and i am not sure of the exact date except that it was either towards the end of january 2007 or beginning of february 2007 (15-jan-2007 through 15-feb-2007).  there was no rash at injection sites, one vaccine administered in left arm, and two other vaccines injected in right arm.  all three were injected at same visit which was approximately 09:00 in the morning.  approximately seven days following the doctor visit I became ill with flu like symptons and the primary sympton was a cough.  i went back for a follow-up visit with a doctor and notified the doctor of my symptons.  doctor said no prescription necessary and that over the counter cough medicine would be recommended.  also, doctor said a lingering dry cough may take several weeks to disappear.				Y					N	01/15/2007	01/22/2007	7	blood draws were taken after the three injections.	UNK	UNK		none.  one week post vaccination patient experienced flu-like symptons lasting for several days.  flu like symptons lasted several days and primary sympton was cough (with phlegm initially and then a dry cough)	to be determined			1						1	Blood test; Cough; Influenza like illness	FLUX~UNKNOWN MANUFACTURER~unknown~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~unknown~3~IM~RA~TETANUS TOXOID (NO BRAND NAME)~1|UNK~UNKNOWN MANUFACTURER~unknown~UNK~IM~LA~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0274551	03/22/2007	FL	62.0	62		M	03/22/2007	Shot administered in left deltoid. Could not raise arm for 10 days and still not able to raise arm directly outward from side position without weakness or pain after more than 5 months. Flu like symptoms were experienced for about a month after having the flu shot. Mild aches, lethergy, lung and nasal congestion.									N	11/08/2006	11/09/2006	1		UNK	PVT	lipitor, lisnpril/hctz	none	no neurological problems. No allergies			1						1	Influenza like illness; Lethargy; Mobility decreased; Muscular weakness; Nasal congestion; Pain; Pain in extremity; Pulmonary congestion	FLU3~SANOFI PASTEUR~42279AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0274553	03/22/2007	ME	35.0	35		M	03/22/2007	Two days after receiving a Pneumococcal vaccine the injection site was red, raised, and warm to touch. Determined to be an injection site reaction. Pt tx with hydrocortisone 1% cream topically with resolution.									Y	03/19/2007	03/21/2007	2	None	PUB	PUB	None	Post-op	None			1						1	Injection site erythema; Injection site induration; Injection site reaction; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0274564	03/22/2007	GU	5.0	5		F	03/22/2007	MOM CALLED TODAY (03/23/07 11:30AM).CLAIMS CHILD HAS FEVER STARTED FEVER OF 38DEGREES CELSIUS AS OF THIS MORNING.  SHE NOTICED TODAY THAT RIGHT ARM HAS PAIN, RED CIRCLE, TIGHT IN TEXTURE.  ALSO THAT SHE HAS A TUMMY ACHE. INFORMED MOM TO CALL DOCTOR FOR FURTHER EVALUATION.  SPOKE TO MOM FEW MINUTES LATER, INFORMED ME THAT DOCTOR TOLD HER FEVER NORMAL, AS FOR RED NOT SURE BUT TO MONITOR AND IF FEVER DOES NOT GO AWAY IN 24HRS TO BRING IN. MOTHER GAVE MOTRIN.									U	03/21/2007	03/22/2007	1	NONE AS OF TODAY.	UNK	UNK	NONE	NONE	NONE			1						1	Abdominal pain upper; Erythema; Pain in extremity; Pyrexia	DTAP~SANOFI PASTEUR~U1986AA~4~IM~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2260AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0274565	03/22/2007	CA	15.0	15		M	03/21/2007	5 mins after shots turn white and bumped self on door and fell slowly to floor. BP and VS normal. Reportedly now with pain and paresthesia of L arm.				Y					Y	03/14/2007	03/14/2007	0		PVT	PUB	NONE	NONE	Nasal allergy during spring			1						1	Blood pressure normal; Fall; Injury; Pain in extremity; Pallor; Paraesthesia	FLU3~SANOFI PASTEUR~U2307AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2609AA~1~~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0274569	03/22/2007	TX	25.0	25		F	03/12/2007	Pt seen in office 3-9-07 with c/o L arm shoulder pain and fever. Symptoms started after vaccination L deltoid 3-7-07. Pt c/o fever at home of 103 deg. 8x8cm demarcated area of erythema L upper deltoid. Started on Keflex.									N	03/07/2007	03/07/2007	0	CBC 3/9/07 WBC 11.9 N 85%, L 10%	PVT	OTH	NONE	NONE	Asthma, Bipolar disorder.			1						1	Full blood count normal; Injection site erythema; Musculoskeletal pain; Pyrexia; White blood cell count increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71829~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1175F~1~~LA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2690AA~1~~RA~TDAP (ADACEL)~1	USA		Influenza
0268230	03/23/2007		22.0			M	03/09/2007	Initial report received from the agency reported, who originally received the report from a health care professional. A 22-year-old male patient, who had no illnesses or pre-existing conditions, had received a dose of ADACEL, lot number C25272AA; a dose of IPOL, lot number Y10302; a dose of MENOMUNE A/C/Y/W-135, lot number UE514AA; a dose of FLUMIST, manufacturer reported, lot number 500428P; a dose of MMR II, manufacturer reported, lot number 0730R; and a dose of TWINRIX, manufacturer reported, lot number AHAVB068BB, on 30 October 2006. Thirty-four days post-immunization, the patient developed Guillain Barre Syndrome and was hospitalized for three days. The patient was treated with Penicillin V-K. At the time of this report, it was unknown if the patient had recovered.					Y	3			Y	10/30/2006	12/03/2006	34		UNK	UNK			The patient had no illnesses, or pre-existing conditions at the time of the vaccination on 30 October 2006.		200603397	1						2	Guillain-Barre syndrome	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~2|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~HEP A + HEP B (TWINRIX)~2|IPV~SANOFI PASTEUR~Y10302~UNK~~~POLIO VIRUS, INACT. (IPOL)~2|MEN~SANOFI PASTEUR~UE514AA~UNK~~~MENINGOCOCCAL (MENOMUNE)~2|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~2|TDAP~SANOFI PASTEUR~C25272AA~UNK~~~TDAP (ADACEL)~2	USA	Hospitalisation	Influenza
0270446	03/23/2007	GA	48.0	48		F	01/24/2007	Initial report received on 28 November 2006 from a health care professional. A 48-year-old female patient, had received a first dose, left arm, IM injection of ADACEL, lot number C2557AA, and a right arm, IM injection of Influenza vaccine, manufacturer reported, lot number AFLUR216AA, on 14 November 2006 at 14:30 pm. The patient stated that she begun to have intermittent bouts of palpitations that evening after receiving the vaccinations. The symptom resolved with 24 hours. She did not seek medical attention or advise. The patient reported that she was taking Advil for general malaise and aching during that period. At the time of this report, the patient had recovered. Follow-up information received on 22 January 2007 from a health care professional. Per the reporter related to the influenza product administered, the flu vaccine is as stated in report (as previously documented). The patient had no significant past medial history. No treatment was sought for the symptoms. The general body aches were treated with Advil only. The patient had received yearly influenza vaccinations in the past. The reporter in this case is the same as in cases 2006-03200 and 2006-03201.									Y	11/14/2006	11/14/2006	0		OTH	OTH			The patient had not taken any other vaccinations within four weeks of the vaccinations on 14 November 2006.		200603273	1						2	Malaise; Pain; Palpitations; Malaise; Myalgia; Palpitations	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA216AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|TDAP~SANOFI PASTEUR~C2557AA~1~IM~LA~TDAP (ADACEL)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUR216AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~2|TDAP~SANOFI PASTEUR~C2557AA~1~IM~LA~TDAP (ADACEL)~2	USA		Influenza
0271991	03/23/2007	IL	0.52	0	.5	M	03/20/2007	Information received on 15 March 2007 from another manufacturer, report WAES0701 USA05034, VAERS# 271991. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: This is in follow-up to report(S) previously submitted on 2/8/2007, 2/21/2007. Information has been received from a certified medical assistant concerning a 7-month0old male with no medical history or allergies who on 10-Aug-2006, 12-Oct-2006 and on the morning of 14-Dec-2006 was vaccinated PO with the first, second and third doses, respectively, of Rotateq (lot #s 654248/0577F and 655484/1032F administration dated not specified). Concomitant vaccination administered on the morning of 14-Dec-2006 included the third IM dose in the left thigh of Pediarix (Lot # AC21B070AA), the second IM dose in the left thigh of PedvaxHib (lot #653596/0281F), the third IM dose in the right thigh of Prevnar (lot #B08675C) and in IM dose in the right thigh of Fluzone (Lot U2243AA). The CMA reported that on 26-Jan-2007, at 0915, the patient presented with a rash and vomiting. The patient was diagnosed with an ileocolic intussusception that could not be reduced by barium enema. The patient was subsequently hospitalized and surgical correction was pending. No laboratory/diagnostic test were performed. The patient was hospitalize for four days and subsequently recovered. The CMA also considered the patients rash and ileocolic intussusception to be life-threatening and other important medical event. The record of testing prior to release of the lots in question have been rechecked and found to be satisfactory. The lots met the requirements and were released. Additional information has been requested.			Y	Y	Y	4			Y	12/14/2006	01/26/2007	43		PVT	PUB			The patient had a history of allergies.		200700807	1						3	Intussusception; Rash; Vomiting; Unevaluable event; Intussusception; Rash; Surgery; Vomiting	RV5~MERCK & CO. INC.~1032F~3~PO~MO~ROTAVIRUS (ROTATEQ)~1|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B070AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~2|FLU3~SANOFI PASTEUR~U2243AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~MERCK & CO. INC.~02181F~2~IM~LL~HIB (PEDVAXHIB)~2|PNC~PFIZER\WYETH~B08675C~3~IM~RL~PNEUMO (PREVNAR)~2|RV5~MERCK & CO. INC.~~3~PO~MO~ROTAVIRUS (ROTATEQ)~2|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B070AA~UNK~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~3|FLU3~SANOFI PASTEUR~U2243AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~3|HIBV~MERCK & CO. INC.~0281F~UNK~IM~LL~HIB (PEDVAXHIB)~3|PNC~PFIZER\WYETH~B08675C~UNK~IM~RL~PNEUMO (PREVNAR)~3|RV5~MERCK & CO. INC.~~UNK~PO~MO~ROTAVIRUS (ROTATEQ)~3	USA	Life Threatening,Hospitalisation	Influenza
0274512	03/23/2007	OH	68.0	68		M	03/20/2007	Initial information received from another manufacturer on 15 March 2007. The report was initially received by the other company from a consumer. A patient (no specific patient identification provided) received a dose of Influenza vaccine and a dose of pneumonia vaccine in November 2006. The trade names, manufacturer and lot numbers were not reported for either vaccine. An unspecified amount of time later, the patient experienced stoke like symptoms. He was hospitalized and on life support for several days. No information regarding recovery status was provided at the time of this report. Follow-up information received on 19 March 2007 from the patient. This information was incorporated into this initial report. The patient stated that he received an influenza vaccine on approximately 18 November 2006. He had no immediate reaction following administration of the vaccine. Three days later, he received a pneumonia vaccine. The patient stated that he did not know the trade name, manufacturer or lot number for wither vaccine. The day after receiving the pneumonia vaccine, the patient stated that he had difficulty speaking and was dizzy. He was taken by EMS to the emergency room and was admitted to the hospital with stroke-like symptoms. He has loss of consciousness and was on life support for two to three days. During hospitalization, he was found to have a dislocated right shoulder and a 'cracked left shoulder. He required surgery on both arms. The patient did not know what the discharge diagnosis was, but stated that it was determined that he had not experienced a stroke or heart attack. He has no history of allergies. At the time of vaccination he was taking Crestor for high cholesterol. At the time of this report, the patient has not recovered, as he still has pain in his left arm and shoulder, and cannot raise his right arm over his head.				Y	Y	0			N	11/18/2006	11/22/2006	4		UNK	UNK	CRESTOR		The patient has no history of allergies. At the time of vaccination he was taking Crestor for high cholesterol.		200700795	1						2	Delirium; Humerus fracture; Loss of consciousness; Dizziness; Joint dislocation; Life support; Loss of consciousness; Mobility decreased; Neurological symptom; Pain in extremity; Speech disorder; Surgery; Upper limb fracture	PPV~MERCK & CO. INC.~~UNK~~UN~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0274619	03/23/2007	OH	13.0	13		F	11/30/2006	Initial report received on 27 November 2006, from a healthcare professional. A 13 year old female patient received on 15 November 2006 Adacel (lot number C2340AA), first dose, intramuscular, Vaqta (lot number 0613F), Fluvirin (lot number 69424). On the same day (15 November 2006), the patient eyes closed for a few minutes and she seemed faint, but then fully recovered. Her arms moved in tremor. The patient's parents reported low grade temperature of 100 (Fahrenheit), headache, earache and sore throat. Corrective treatment was not reported. The patient outcome was not reported. The patient's medical history was not reported.									Y	11/15/2006	11/15/2006	0		UNK	UNK					200603248	1						1	Body temperature increased; Ear pain; Headache; Pharyngolaryngeal pain; Syncope; Tremor	FLU3~EVANS VACCINES~69424~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~MERCK & CO. INC.~0613F~UNK~~~HEP A (VAQTA)~1|TDAP~SANOFI PASTEUR~C2340AA~1~IM~~TDAP (ADACEL)~1	USA		Influenza
0274665	03/23/2007	GA	40.0	40		F	12/08/2006	3 Hours after administration began swelling and tender to touch - 6 hours after administration. Started fever. 24 hours after red and still tender.				Y					Y	12/06/2006	12/07/2006	1		PVT	PVT						1						1	Erythema; Oedema peripheral; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~U2271AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0620F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0274670	03/23/2007	WA	26.0	26		M	03/19/2007	Patient vaccinated on 2/26/07 for smallpox, onset of sx. on 03/07/07. Patient presented with malaise, low grade temp. and expanding area of erythema around inoculation site on left deltoid (approximately 20cm x 7cm), thought to be c/w cellulitis. Tx: Keflex 500mg PO TID x 10 days.				Y					Y	02/26/2007	03/07/2007	9		MIL	MIL	Keflex 500mg QID x 10 days; Tuberculin Skin test (PPD), Aventis, Lot # C2460AA		Allergies: Sulfa-drugs, PMH: GERD			1						1	Cellulitis; Injection site erythema; Malaise; Pyrexia	ANTH~EMERGENT BIOSOLUTIONS~FAV103~1~~~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~~3~~~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020076~1~~LA~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~Z0425~1~~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|UNK~UNKNOWN MANUFACTURER~C2460AA~2~~~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0274671	03/23/2007	TX	1.67	2	.1	M	03/14/2007	Swelling and blister formation around the site of both Hep A and Influenza injections (R) THIGH.				Y					Y	02/23/2007	02/24/2007	1	NONE	MIL	MIL		NONE	NONE			1						1	Injection site swelling; Injection site vesicles	FLU3~SANOFI PASTEUR~U2285AA~UNK~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1281F~UNK~~RL~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0274645	03/24/2007		22.0	22		F	03/24/2007	PT REPORTED SENSATION OF HER THROAT SWELLING CLOSED, SIMILAR TO WHEN SHE IS EXPOSED TO MUSHROOMS (ALLERGIC TO MUSHROOMS).				Y					Y	03/23/2007	03/23/2007	0	N/A	MIL	MIL		NONE	MUSHROOMS	NONE~ ()~NULL~~In Patient		1						1	Pharyngeal oedema	ANTH~EMERGENT BIOSOLUTIONS~FAV102~1~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U2238AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB086AA~3~IM~RA~HEP A + HEP B (TWINRIX)~1|TYP~BERNA BIOTECH, LTD.~Z0663~2~IM~GM~TYPHOID LIVE ORAL TY21A (VIVOTIF)~1	USA	Emergency room visit	Influenza
0267600	03/26/2007	VA	49.0	49		F	03/22/2007	Initial report received on 15 March 2007 from the patient. A 49-year-old female patient who had no concurrent illnesses, and medical history of allergies to Tylenol with Codeine and Keflex, and who was taking Tamoxifen, had received a fifth, left arm intramuscular injection of FLUZONE SV '2006-'2007 USP, lot number U2275AA, on 10 November 2006 at 06:30 a.m. Approximately 48 hours post-immunization, around 18:30 p.m. on 12 November 2006, the patient developed a raised red rash under the armpit (also reported as under affected arm) that lasted three days. Ninety-six hours post-immunization, the patient noticed an indentation of armpit (also reported as 3 x 1 indentation in arm) and one week later, she experienced deltoid muscle atrophy in that area. The patient provided pictures of her left upper arm. The patient reported that she had experienced any other adverse events with prior flu vaccinations and had not received any other vaccinations within four weeks of the vaccination on 10 November 2006. The patient indicated that she had been evaluated by her primary care physician so she could obtain referrals to a physical therapist, rheumatologist, and dermatologist. At the time of this report, the patient was being evaluated by an orthopedist. Treatment received and diagnostic testing's performed were not reported. The patient has not recovered.				Y					N	11/10/2006	11/12/2006	2		PVT	PVT	Tamoxifen		The patient had no illnesses at the time of the vaccination on 10 November 2006. The patient reports no previous adverse events with prior vaccinations. Pre-existing medical conditions included allergies to Tylenol with codeine and Keflex.		200700823	1						3	Injection site atrophy; Muscle atrophy; Rash erythematous	FLU3~SANOFI PASTEUR~U2275AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Emergency room visit	Influenza
0274770	03/26/2007	GA	0.51	0	.5	M	03/19/2007	S/P Vaccine 3/5/07 DTaP/IPV/Prevnar/Flu, on 8pm 3/6. Patient experience sz like activity involuntary body jerky, no x 1 positive T97 repeat <1 min at hospital. Admitted with neuro consult negative CT scan, negative LP, (-) HM, EEG spikes 04/05/07-records received from facility for DOS 3/7-3/8/07. DC DX: Seizure. Abnormal movement and infant spasm. Admitted with repetitive jerking, flexing episode. No eye deviation no clonic movements. Temp 98.9 No seizures during admission					Y	2			Y	03/05/2007	03/06/2007	1	(-) HM, (-) CT scan, EEG small spikes records received 4/5/07-EEG: many right occipital spikes were noted. Pyridoxine injection did not change the EEG record. This record is abnormal, spikes seen over right occipital regions are consistent with a discharging focus in those regions. MRI brain normal. CT head no acute intracranial abnormality. Blood, urine and CSF culture negative. C-reactive protein 4.3 (H). CSF monos/macrophages 52.0 (H). Calcium 10.9 (H)	PVT	UNK	NONE	NONE	NONE			1						1	Body temperature decreased; Computerised tomogram normal; Convulsion; Dyskinesia; Electroencephalogram abnormal; Nuclear magnetic resonance imaging normal	DTAP~SANOFI PASTEUR~U1751BA~3~~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2307AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0240L~3~~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~B08646F~3~~RL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0274778	03/26/2007	OH	42.0	42		F	01/03/2007	Flu symptoms, fatigue, nausea, vomiting, muscle pain, hives, itching. Lasted 7 days.				Y					Y	12/21/2006	12/21/2006	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Fatigue; Influenza; Myalgia; Nausea; Pruritus; Urticaria; Vomiting	FLU3~SANOFI PASTEUR~U2280AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0274784	03/26/2007	MI	6.0	6		F	03/21/2007	Phone call from grandmother stated she was instructed by Dr to call health dept. Child had vaccines 3/19/07 around 2 pm. By 8pm that night Left arm swollen at injection site with warm red rash, size of a softball. Temp 100.2, nausea, body aches and pain. Stated this happened the last time Dtap given also. Benadryl, Tylenol and ice pack given.				Y					N	03/19/2007	03/19/2007	0	NONE	PVT	OTH	NONE	NONE	Asthma	fever, rash left thigh, swollen and red~DTaP (no brand name)~3~3.00~In Patient		1						1	Body temperature increased; Injection site erythema; Injection site rash; Injection site swelling; Injection site warmth; Nausea; Pain	DTAP~SANOFI PASTEUR~C2521AA~4~IM~LA~DTAP (DAPTACEL)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69240~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~11030-2~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0274790	03/26/2007	VA	11.0	11		F	03/20/2007	R arm redness, pain, swelling. Shortly after.									Y	03/06/2007	03/09/2007	3		UNK	PVT	Adderall	NONE/Well child	NONE			1						1	Erythema; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2307AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~00886~1~IM~LA~HPV (GARDASIL)~1|TDAP~SANOFI PASTEUR~C2638AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0274792	03/26/2007	MA	4.0	4		F	03/15/2007	Mother reported child was noted to have bright redness and swelling in left anterior thigh starting 6-8 hours and thriving for forty eight hours.				Y					Y	03/13/2007	03/13/2007	0	Client receiving oral Benadryl and Cephlosporin orally per father. question dosage.	PUB	PUB		NONE	NONE			1						1	Injection site erythema; Injection site swelling	DTAP~SANOFI PASTEUR~C2553AA~5~~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2313AA~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1030~4~~RL~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~0828F~2~~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0274796	03/26/2007	TX	2.0	2	.4	M	03/26/2007	Health network received telephone call at 755 AM on 3-26-07. Client/ child having symptoms of fever, swelling and redness to Left leg since 3/23/07 around 5pm. Wants to know what to do? Health network recommended ice packs and infant/children motrin as recommended by container. Ice packs to Left leg as tolerated by child. Mom, already did that since 03-23-07. Health network recommended Primary medical doctor or ER of choice, since symptoms still occurring, mom agreed.				Y					N	03/23/2007	03/23/2007	0		PUB	PUB	NONE	NONE	NONE	~ ()~~5.00~In Sibling		1						1	Injection site erythema; Injection site swelling; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21DA15AA~2~~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2220CB~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0651F~1~~LL~HEP A (VAQTA)~1|HIBV~SANOFI PASTEUR~UF084AA~1~~LL~HIB (ACTHIB)~1|MMRV~MERCK & CO. INC.~0301F~1~SC~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08672D~2~~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0274835	03/26/2007	AZ	1.42	1	.4	M	03/26/2007	Vaccines were given at 3pm. Child cried unconsoleably until 8pm.  Fever 103.2F, listless. Mom called ER & was given a nurse hot-line. Gave Tylenol alternating with Motrin. Child went to sleep. When awake fever down & no crying.									Y	01/02/2007	01/02/2007	0	N/A	PUB	PUB	None	None	None known		AZ0702	1						1	Crying; Listless; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B051AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2176JA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0804F~1~IM~RA~HEP A (VAQTA)~1|HIBV~MERCK & CO. INC.~0082F~3~IM~RL~HIB (PEDVAXHIB)~1|MMRV~MERCK & CO. INC.~0062F~1~SC~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B0865E~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0274946	03/27/2007	NH	7.0			F	03/26/2007	Information has been received from a registered nurse concerning a 7-year-old female with asthma and allergies to Zithromax, cyprohetador, beef, corn, soy, and milk, chronic gastric paresis, eosinophilic, and esophagitis who on 26-FEB-2007 at 4:30PM was vaccinated SC in the right arm with a second dose of Varivax (lot #656079/1306F). Concomitant therapy that day at 4:30PM included a forth dose of Fluzone (lot # U62271AA) administered in the right deltoid. Additional concomitant therapy included montelukas sodium, Flovent, Prevacid, Miralax and Vitamins (unspecified). On 26-FEB-2007 at 5:45PM, the patient's whole body became bright red, and the child became itchy and warm with hives. In additional, the patient's eyes started to swell. After talking to the doctor, 25mg Benadryl was given and was told to go to the ER. The patient began wheezing on the way to the ER. Epinephrine was given in the ER and the patient was discharged on prednisone. Subsequently, the patient recovered. There was no product quality complaint. The events were considered to be immediately life-threatening and other important medical events by the reporter. Additional information has been requested.			Y	Y					Y	02/26/2007	02/26/2007	0	UNK	PVT	PUB	Flovent, Prevacid, Singulair, Miralax, Vitamins (unspecified).	Drug hypersensitivity; Food allergy; Gastric disorder; Eosinophil count abnormal; Oesophagitis; Asthma			WAES0703USA02777	1						1	Erythema; Eye swelling; Pruritus; Skin warm; Urticaria; Wheezing; Erythema; Eye swelling; Pruritus; Skin warm; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U62271AA~4~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1306F~2~SC~RA~VARICELLA (VARIVAX)~1|FLU3~SANOFI PASTEUR~U62271AA~4~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|VARCEL~MERCK & CO. INC.~1306F~2~SC~RA~VARICELLA (VARIVAX)~2	USA	Life Threatening	Influenza
0274950	03/27/2007	IL	1.15	1	.1	M	03/22/2007	Fever & Seizure records received 5/3/07-notes received DX Febrile Seizure same day as vaccines. Temp 103.6 in ER. Shaking, eyes rolled questionable cyanosis				Y					Y	11/13/2006	11/14/2006	1	Per hospital ER	PUB	PUB						1						1	Convulsion; Pyrexia	DTAPH~SANOFI PASTEUR~U1857AB~1~~RL~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~42200LA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~0820F~1~~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B8683D~4~~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0274966	03/27/2007	CT	6.0	6		M	03/21/2007	Patient started with headache immediately after vaccine administered. Headache lasted 1 month & resolved on own. No improvement with Amoxicillin 600 mg BID x 10 D. and Flonase nasal spray									Y	11/17/2006	11/17/2006	0		PVT	PVT	None	None	None			1						1	Headache	FLUN3~MEDIMMUNE VACCINES, INC.~500436P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0274969	03/27/2007	OR	1.5	1	.5	M	02/20/2007	Blister, redness - Lt, Hep A site.									Y	01/02/2007	01/02/2007	0	None	PVT	PUB	None		None			1						1	Injection site erythema; Injection site vesicles	FLU3~SANOFI PASTEUR~UT2176KA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0651F~1~~LL~HEP A (VAQTA)~1|HIBV~MERCK & CO. INC.~1013F~3~~RL~HIB (PEDVAXHIB)~1	USA		Influenza
0275000	03/27/2007	IN	1.42	1	.4	F	03/27/2007	2-9-07 Mother noticed an indentation on Right leg.  Denies any redness, or warm skin to touch.  No difficulty of walking noted.  3-26-07 Mother brought child to clinic with complaint of quarter size indentation on right upper outer quadrant of thigh.  Denies any difficulty walking or redness or tenderness at site. States she notices this after she received her last set of shots.   Encouraged her to keep child walking and to report any changes in site or condition of child.				Y					Y	01/19/2007	02/09/2007	21		PUB	PUB						1						1	Injection site atrophy	DTAPH~SANOFI PASTEUR~U14260C~1~IM~LL~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~U2175HA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB124BA~1~IM~LL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~B08682D~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0275003	03/27/2007	VA	56.0	56		F	03/27/2007	Encounter Background Information: Referred by doctor on 3/1/07 with large local reaction to arm following influenza vaccine. Received IM influenza on 2/27/07 (has had several times before w/o AE). Within 4-8 hours post immun her arm developed a red rash at the site, swollen, tender, afebrile w/o bumps just redness at site later 6x5inches circular diameter. It did not encircle the arm. Site was pruritic. Also had headache, fatigue and overall body aches which have resolved/eased 24 hours later. Concerned if this was a normal reaction or an adverse event to be concerned with. She wore a bandaid over site all day, possible latex components. Reported history of Latex allergies (skin rash, peeling skin requiring prednisone use), several drug and environmental allergies. She reported allergy to epi (hypertensive crisis and tremors) and steroid creams (peeling skin/rash). Allergy to alcohol. Hx asthma, HTN, GERD, migraines, and bowel disorders. On numerous medications. She contacted office who stated she believed this was a latex reaction but referred for f/u. Skin symptoms swelling, redness to vaccine site 6 hours after vaccinated with red rash. Swelling reported to be 6 in x 4.5 in extending 1/2 way to elbow. was itching w/o bumps. Arm tender. Wearing latex bandaid over vac site until late that night and removed. No otolaryngeal symptoms, No cardiovascular symptoms, No pulmonary symptoms.				Y					Y	02/27/2007	02/27/2007	0	none	MIL	MIL	verapamil, clonadine, lisinopril, Diovan, asa, zytaloprim, folic acid, Prilosec, albuterol	denies...	latex allergy, asthma, HTN, GERD/PUD, colorectal surgery/sbo, vulvitis, migraines	denied~ ()~~0.00~Patient		1						1	Drug hypersensitivity; Fatigue; Headache; Hypersensitivity; Injection site erythema; Injection site pain; Injection site pruritus; Injection site rash; Injection site swelling; Latex allergy; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0271809	03/28/2007	SC	3.0	3		M	03/23/2007	Initial report received from a health care professional on 01 February 2007. A 3 year old, male patient (with a history of pulmonary stenosis and environmental allergies) developed a large red area on the right thigh and could not stand on leg, within 24 hours after he received his fourth dose of Ipol (lot number Z0240) subcutaneously in the right thigh; his third dose of Fluzone (lot number U2249AA) intramuscularly in the left thigh and his fifth dose of Infanrix (lot number AC14B040BA) intramuscularly in the left thigh, on 29 January 2007. He did not have any illness at the time of vaccination. X-rays were taken of the right leg - the results were not provided. At the time of the report, the patient had not recovered. Follow up information received on 15 March 2007, from a health care professional. The patient did not have illness at the time of vaccination. The patient required hospitalization. Admitted on 31 January 2007 and discharged on 01 February 2007. The following information was taken from the hospital and clinical records. Patient developed pain, swelling and redness in the right thigh following IPV vaccination the day before. He was originally seen on 30 January 2007, where he was reportedly afebrile with normal white count, normal plain films and was discontinued home. Then on 31 January 2007, he increased swelling and pain and was walking with a limp, still afebrile and nontoxic. Physical examination was remarkable only for the right lower extremity, he had anterior thigh erythema, along with some posterior thigh erythema and some diffuse swelling over the thigh. He was tender tp palpitation mostly over the anterior thigh and mildly over the right knee. Area where the injection was given had surrounding erythema and swelling. CBC showed a white count of 11, Blood cultures were negative. Patient started on Clindamycin IV empirically. On 01 February 2007 he was walking around the room with slight limp, complaining only of some mild right knee pain. Plain films showed evidence of diffuse soft tissue swelling about the right knee. A small effusion could not be ruled out and per Radiology there were no bony abnormalities appreciated. Normal labs, normal vital signs. Discharge with Keflex b.i.d for 7 days along with Motrin p.r.n for pain and warm compress p.r.n. Concomitant medication included Flonase. the patient was seen in a clinic on 13 February 2007. The leg had healed well with no residual problems from it. The patient also experienced cough and green nasal drainage for six days. Cough at bedtime was worse. He was diagnosed with allergic rhinitis / sinus and otitis media.				Y	Y	2			Y	01/29/2007	01/31/2007	2		PVT	PUB	NASONEX, VIRAVAN, FLONASE		History of pulmonary stenosis and environmental allergies. He did not have any illness at the time of vaccination.		200700339	1						2	Injection site erythema; Injection site oedema; Injection site warmth; Arthralgia; Blood culture negative; Cough; Dysstasia; Erythema; Full blood count; Gait disturbance; Injection site erythema; Injection site pain; Injection site swelling; Joint effusion; Nasal mucosal discolouration; Oedema peripheral; Otitis media; Pain in extremity; Rhinitis allergic; Rhinorrhoea; Sinus disorder; Soft tissue disorder; White blood cell count normal; X-ray limb	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B040BA~4~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2249AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0240~3~SC~RL~POLIO VIRUS, INACT. (IPOL)~1|DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B040BA~5~IM~LL~DTAP (INFANRIX)~2|FLU3~SANOFI PASTEUR~U2249A~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|IPV~SANOFI PASTEUR~Z0240~4~SC~RL~POLIO VIRUS, INACT. (IPOL)~2	USA	Hospitalisation	Influenza
0275138	03/29/2007	WA	18.0	18		M	03/27/2007	Numbness, tingling and weakness in calves, ankles and feet which progressed to diagnosis of GUILLAIN BARRE syndrome. Neuropathy Calves. Sensation, increase Calves and feet. Paresthesia Feet. 03/30/07-records received with report. Numbness, tingling and weakness in calves, ankles and feet which progressed to DC of Guillain Barre Syndrome. Developed parethesia of lower extremities vaccines included meningococcal and flu. One month after vaccines he received yellow fever 7/13/06. He had an URI in the preceding month. Felt clinically well and had no illness during preceding month of training. On 7/14/06 felt sick with fever, congestion, rhinitis and headache. 7/16/06 awakened with numbness in both feet. Admitted to ICU for 5 days with DX peripheral neuropathy. Systemic symptoms did not improve and on 8/6/06 seen by neuromuscular specialist at UCSD and DX with GBS. TX with IVIG for 3 days. No improvement with treatment. Left Marine Corp 9/8/06 and continued to have numbness and tingling in feet, feet extremely sensitive to touch, cannot flex or wiggle his toes, pressure on calf muscles causes pain. 1/4/10 Patient had not regained function completely in his legs. His doctor state he never will, he will be permanently disabled.				Y	Y	3			N	07/13/2006	07/16/2006	3	Case reviewed. Determined as	MIL	MIL	NONE	NONE Records received with report:He had an URI in the preceding month.	NONE			1						1	Guillain-Barre syndrome; Hypoaesthesia; Muscular weakness; Neuropathy; Paraesthesia; Yellow fever; Asthenia; Guillain-Barre syndrome; Hypoaesthesia; Paraesthesia	HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB05ACA~2~~~HEP A + HEP B (TWINRIX)~1|IPV~SANOFI PASTEUR~Y8CA962~1~SC~~POLIO VIRUS, INACT. (IPOL)~1|MNQ~SANOFI PASTEUR~~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TD~SANOFI PASTEUR~C2457AA~1~~~TD ADSORBED (NO BRAND NAME)~1|YF~SANOFI PASTEUR~0383R~1~~~YELLOW FEVER (YF-VAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~2|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~2|IPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~2|MNQ~SANOFI PASTEUR~U2057A~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|YF~UNKNOWN MANUFACTURER~~UNK~UN~UN~YELLOW FEVER (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0275149	03/29/2007	VA	4.0	4		F	03/26/2007	Child received 4 yr vaccines for school entry on Friday 3/23/07 in our open immunization clinic. Redness, swelling and itching started in Left deltoid area. The next day (Saturday) mother started ice packs and gave Child Tylenol for discomfort for 1 dose. Right exotropia noted in right arm as well. Left arm better per mom today.										03/23/2007	03/24/2007	1	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Strabismus	DTAP~SANOFI PASTEUR~C2650AA~5~~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2307AA~4~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB139BA~1~~LA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~Z0018~4~~LA~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~1553F~2~~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0270902	03/30/2007	MA	65.0	65		F	03/27/2007	States that the arm vaccine was administration has been sore for 1 month (since vaccine was given).									Y	12/04/2006	12/04/2006	0	Creatine kinase drawn	PUB	PUB						1						2	Blood creatine phosphokinase; Injection site pain; Blood creatine phosphokinase; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U42279AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0275228	03/30/2007	MN	46.0	46		F	03/26/2007	By noon on day of shot deep pain in arm in immediate area where shot was given, no rash or redness occurred. I couldn't move arm more than 45 degree angle anyway. I had absolutely no problems with arm before shot was given.  Was on work restrictions, went thru 18 physical therapy treatment. Arm is better but not near full recovered. Arm bothers me thru the night I wake up with pain quite often. I can't reach up or back or lift anything too heavy without pain.									N	11/10/2006	11/10/2006	0	NONE	MIL	MIL		NONE	Penicillin			1						1	Hypokinesia; Injected limb mobility decreased; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72002~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0275312	03/30/2007	MA	67.0	67		F	03/30/2007	Patient came to BOH on 3/27/07 to report adverse reaction from flu shot. She had no complaints until before Christmas (cannot give exact date) C/O burning in L arm, no redness, no swelling. Did not see MD. In Jan she felt lump in L arm (50 cent size) MD said it was bursitis - now lump is 25 cent size, no pain, no redness.									Y	12/05/2006			None	PUB	PUB		None	None			1						1	Burning sensation; Bursitis; Skin nodule	FLU3~SANOFI PASTEUR~U2258AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0275301	04/02/2007		0.5	0	.5	M	04/02/2007	My son was given the first shot (of the 4 that needs to be given) on the 23rd March 07 at 2030 Hrs in the evening - he had a seizure the very next day on the 24th at 1120 Hrs and was rushed to the ER. CT Scan - LP Test and EEG was conducted on him and all were normal. He was hospitalized for a period of 5 days (2 Days of ICU Care) now he seems fine but i would like to know the possibilities of the Seizure to relapse in the future - the medication prescribed for him is EPTOIN a syrup and i was also told that it has some serious side effects to the Brain.				Y	Y	5			U	03/23/2007	03/24/2007	1	CT Scan - Normal / LP Test - Normal / EEG - Normal	PVT	PVT		None	None			1						1	Computerised tomogram normal; Convulsion; Electroencephalogram normal; Lumbar puncture normal	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0275354	04/02/2007		63.0	63		F		On 11/Oct/2006, a report was received, via a company representative, concerning a 63-year-old female. No details were provided regarding the vaccinee's medical history or concomitant medications. On 10/Oct/2006 the vaccinee received Fluvirin, intramuscularly. On the same day, 10/Oct/2006, the vaccinee also received a pneumonia vaccine. The following day, the vaccinee experienced a raised blood glucose of 300. Follow-up information will sought. A follow-up report was received from a healthcare professional on 27/Mar/2007, concerning a 63-year-old female vaccinee. The vaccinee has a history of diabetes, blister following oral administration of Statins in 2003, Ovary Ooperectomy in 1997, Gallbladder removal in 1996 and Tonsillectomy and Adenoidectomy in 1955. The vaccinee's concomitant medications include Humalog, 60u once a day, subcutaneously for diabetes, since 1997, Humalein, 160u once a day, subcutaneously for diabetes, since 1987, Acupril for spill protein 20 mg once a day, orally since 1999. Lasix, 1 tablet once a day, orally as a diuretic, from 2006 and Zetia, 1 tablet once a day, orally for raised cholesterol from 2005 to 2006. On 10/Oct/2006 the vaccinee received Fluvirin. On the same day, 10/Oct/2006, the vaccinee also received Pneumovax 0.5ml intramuscularly into her right deltoid. The following day, 11/Oct/2006, the vaccinee experienced a raised blood sugar level of 294. The vaccinee had fasted prior to administration of the test. The symptoms have resolved. The reporter considers the event to be serious, however her causal assessment is unknown. Follow-up information will be sought.										10/10/2006	10/11/2006	1	BLOOD GLUCOSE 10/11/06 294 Fasted prior to test	UNK	UNK	HUMALOG, HUMALEIN, ACUPRIL, LASIX, ZETIA		The vaccinee has the following medical history: Statins 2003 - blister on oral administration, Oopherectomy - Ovary - 1997, Gallbladder removal - 1966, Tonsillectomy and Adenoidectomy - 1955, Diabetes		CVOX200600140	1						1	Blood glucose increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~07278~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1048P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0275357	04/02/2007	CA				F	03/29/2007	Initial report received on 26 March 2007 from the patient. A female patient (demographic not provided) had received an INFLUENZA VACCINE, sometime in December 2003. The trade name, manufacturer, lot number, route and site of administration not provided. The next day, the patient woke with her left shoulder on fire, left rib hurt, left buttock hurt and left foot hurt. The symptoms have progressed to being Totally crippled in my left leg for the next two years. The patient reports that she has been frozen with massive swelling in my neck, jaw, right foot and hands which throb and is very painful. The patient indicated she had to go on disability. The patient has been to many doctors and has been prescribed many medications. The medications are only band-aids, the culprit never goes away. The patient was subsequently diagnosed with reactive arthritis. The patient was told she would recover, but it would be a very slow recovery. The patient stated that I am very slowly getting better, but this has ruined my life over the past thee years. She has been almost a house-bound vegetable for the last two years. The patient is recovering.				Y				Y	N	12/01/2003	12/02/2003	1		UNK	UNK					200700910	1						1	Arthritis reactive; Burning sensation; Hypokinesia; Local swelling; Musculoskeletal chest pain; Oedema peripheral; Pain; Pain in extremity; Swelling; Walking disability	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0275369	04/02/2007	RI	0.5	0	.5	M	04/01/2007	Patient developed fever 7 hours after getting shots. Fever went up to 105 rectal by 23-24 hours after shots. Then around 24 hours after shots patient had seizures (2 seizures lasting a few minutes). In ER he was alert and had URI symptoms and was diagnosed with Otitis Media. Admitted for vomiting. 10/15/07-records reviewed for DOS 3/30-3/31/07-DC DX: Febrile Seizure. Vomiting. Seen in ED multiple episodes with temp to 105.3. temp in ED 101.3 generalized shaking all over, eyes deviated to left. .				Y	Y	1			Y	03/29/2007	03/30/2007	1	LP (-) 10/17/07-records received-CSF culture no growth. CSF WNL.	PVT	PUB		URI 10/17/07-records received-Seen earlier in week with C/O decreased PO intake, lethargy and fevers	Seizure disorder 10/15/07-records received- HX of seizures since 1/07.			1						1	Convulsion; Lumbar puncture normal; Otitis media; Pyrexia; Upper respiratory tract infection; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B090AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2201EA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08679B~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1166F~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0275379	04/02/2007	AZ	5.0			M	03/21/2007	Redness, swelling, warm at touch.									Y					PVT	PUB						1						1	Erythema; Skin warm; Swelling	FLU3~SANOFI PASTEUR~U2249AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~AHBVB180AA~4~~LA~HEP B (RECOMBIVAX HB)~1|VARCEL~MERCK & CO. INC.~1154F~2~~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0275380	04/02/2007	MN	11.0	10		F	03/17/2007	Mother of patient called on 2/23/07 and reported that child had developed a circular area less than 1 in diameter around the injection site. Described as white bumps that itched. Child had removed the bandaid shortly after receiving the vaccination. Mother described that child has dry skin and alcohol used to cleanse area may have caused increased dryness. Follow up call on 2/26 and area improving/clearing.										02/20/2007	02/21/2007	1		PUB	PVT	none	none	none			1						1	Dry skin; Injection site discolouration; Injection site pruritus; Injection site rash	FLU3~SANOFI PASTEUR~U2282AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0275389	04/02/2007	IA	6.0	6		M	03/29/2007	Fluzone given IM right deltoid 3/27/07. Presents to health department this AM with localized redness and induration of 4 cm. Circular area right deltoid with c/o pain. Able to move arm easily. I to use warm packs and Tylenol - return 3/30 if worse. School nurse also notified to check today and monitor.									U	03/27/2007	03/29/2007	2		PUB	PUB	None	None	None			1						1	Injection site erythema; Injection site induration; Injection site pain	FLU3~SANOFI PASTEUR~U2262AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0275420	04/02/2007	GA	66.0	66		F	04/02/2007	At site of injection, redness, swelling, cellulitis									Y	11/09/2006	11/18/2006	9		PVT	PVT	Hydrochlorithiazde/lisinopril, lipitor, allegra, fluticasone, tetracycline, aspirin, synthroid	Hypertension, Acne, Hypercholesterolemia	HTN, Acne, Cholesterol			1						1	Injection site cellulitis; Injection site erythema; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua236BA~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1175F~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0275424	04/02/2007	GA	26.0	26		F	04/02/2007	Pain, redness, swelling in arm along with fever				Y					Y	12/07/2006	12/11/2006	4	MRI of upper extremtity confirmed the cellulits, but no abscess.	PVT	PVT			Albuterol, Advair, zyrtrec, topamax			1						1	Cellulitis; Erythema; Nuclear magnetic resonance imaging abnormal; Oedema peripheral; Pain in extremity; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua202ba~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1128F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0275441	04/02/2007	CA	1.19	1	.2	F	02/05/2007	Parents & child came over the clinic after 2 days of vaccinating stated child both thighs are sore and child was fussy. Noted both thighs are swollen with redness and hot to touch. No temp reported high. Told parents will have moderate soreness welling and redness and normal after having shots. No treatment done.									U	02/02/2007	02/03/2007	1		PUB	PUB	None	None				1						1	Agitation; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2191BA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF020AA~4~~LL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~1027F~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08674H~3~~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0275442	04/02/2007	WI	1.12	1	.1	M	04/02/2007	3/30/07 fever 103 rectal; continues as low grad as of 4/2/07. 3/31/07 light cough and runny nose; cough progressing. 4/1/07 rash - lower abd and back.									U	03/22/2007	03/30/2007	8		PUB	PUB		Getting over cold no fever	None			1						1	Cough; Pyrexia; Rash; Rhinorrhoea	FLU3~SANOFI PASTEUR~U2220AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB099CB~1~IM~RA~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0253F~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0442F~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0275460	04/03/2007	CA	4.0	4		F	03/23/2007	Right arm large (13x9 cm) red, hot, painful area. No fever. Tx: Keflex 250/5ml 1 tsp PO 96 hours x 7 days, Benadryl 12.5/5ml 1/2 tsp PO q4-6 PRN itching PRN ice/ Tylenol. Follow-up 4-5 days.									Y	03/21/2007	03/23/2007	2	None	OTH	PUB		None	None			1						1	Erythema; Pain in extremity; Skin warm	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B032AA~5~~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2272AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1051~4~~LA~POLIO VIRUS, INACT. (IPOL)~1|VARCEL~MERCK & CO. INC.~1555F~1~~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0275463	04/03/2007	WA	37.0	37		F	03/28/2007	Local reaction left deltoid site of Pneumovax injection, administered along with Influenza vaccination on 3/23, started 3/25 symptoms resolved by 3/28.									Y	03/23/2007	03/25/2007	2		OTH	PUB	SINGULAIR, ADVAIR, ALBUTEROL INHALER	None	Asthma			1						1	Injection site reaction; Local reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F602611~UNK~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1137F~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0275467	04/03/2007	ND	50.0	50		F	03/19/2007	Pt given Pneumovax & Influenza vaccine in left deltoid IM 1 inch apart. Pt to ER on 3-11-07. Treated with Rocephin 1 gm IM and Toradol 60mg IM. Pt seen again on 3-12-07 in clinic - treated with Augmentin 875 mg PO Q 12 hrs x 10 days. Pt has not been seen in clinic since this visit.				Y					U	03/09/2007	03/11/2007	2	WBC 20.6 on 3-11-07 Diagnosed with cellulitis of left arm	PUB	PUB		None Known	COPD, RA, GERD, Depression, back & knee pain			1						1	Cellulitis; Injection site cellulitis; White blood cell count increased	FLU3~SANOFI PASTEUR~U2292AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1174F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0275520	04/03/2007	OK				M	03/21/2007	This case was reported by a pharmacist and described the occurrence of erythema multiforme in an adult male subject who was vaccinated with influenza virus vaccine (Influenza vaccine, manufacturer unspecified) for prophylaxis. On an unspecified date in 2006, on or before 01 December 2006, the subject received unspecified dose of Influenza vaccine. At an unspecified time following the administration of influenza vaccine, on an unspecified date in 2006, on or before 01, December 2006, less than one year after vaccination with influenza vaccine, the subject experienced erythema multiforme, The outcome of the event was not reported. Comment: Erythema multiforme was assessed as medically serious by GSK.									U				UNK	OTH	OTH		unknown	The subject's medical history, concurrent conditions, and concurrent medications were not reported.		A0630661A	1						1	Erythema multiforme	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0275521	04/03/2007	NC	55.0			M	03/21/2007	This case was reported by a healthcare professional and described the occurrence of injection site pain in a 55 year old male subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. Concurrent medications included Ramelteon (Rozerem). The Subject had received influenza virus vaccine in previous years with no subsequent adverse events. On 09, November 2006 the subject received unspecified dose of Fluarix in the left deltoid. On 09, November 2006, less than one day after vaccination with Fluarix, the subject experienced injection site pain. The subject described the pain as constant and five out of ten for the 1st three days, then 3 out of 10 since that time. At the time of initial reporting, 05, December 2006, the event was improved. Follow-up received on 28, December 2006 indicated that the subject's relevant medical history included chronic interstitial cystitis and chronic prostatitis. The subject has taken other influenza vaccines without problems. the reporter considered that the events were possibly related to the use of Fluarix.									N	09/11/2006	09/11/2006	0		OTH	PVT	Ramelteon	Chronic prostatitis, Drug allergy, interstitial cystitis	The subject's medical history included chronic interstitial cystitis, chronic prostatitis and allergy to Relafen, Cipro and bee venom	This vaccine had no adverse events following receipt of prior immunization of influenza virus vaccine~ ()~~0.00~In Patient	A0631021A	1						1	Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA239AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0275522	04/03/2007	NY				F	03/21/2007	On 12 December 2006 the subject received unspecified dose of Influenza vaccine. On 12, December 2006, less than one day after vaccination with Influenza vaccine, the subject experienced an unspecified adverse event. At the time of initial reporting. 12, December 2006, the event was worse.									U	12/12/2006	12/12/2006	0		OTH	OTH		unknown			A0631789A	1						1	Adverse event; Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0275523	04/03/2007	CA				F	03/23/2007	This case was reported by a healthcare professional and described the occurrence of injection site pain in an adult female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. The subject received influenza virus vaccine in previous years with no subsequent adverse events. On 07, December 2006 the subject received unspecified dose of Fluarix, On an unspecified date in December 2006, within one week after vaccination with Fluarix, the subject experience injection site pain. At the time of initial reporting, 18, December 2006, the event was ongoing and the healthcare professional reported that the injection site pain, has lasted for a week The healthcare professional considered the event was probably related to vaccination with Fluarix.									N	12/07/2006				UNK	UNK		unknown	The subject's medical history, concurrent conditions, and concurrent medications were not reported. The healthcare professional reported that 2 other subjects experienced injection site pain following receipt of Fluarix. Please see cases A0631988A and A0631989A	This vaccine had no adverse events following receipt of prior immunizations of influenza virus vaccine~ ()~~0.00~In Patient	A0631984A	1						1	Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0275524	04/03/2007	CA				F	03/21/2007	this subject received influenza virus vaccine in previous years with no subsequent adverse events. On 07, December 2006 the subject received unspecified dose of Fluarix. On an unspecified date in December 2006, within one week after vaccination with Fluarix, the subject experienced injection site pain. The subject subsequently fell and aggravated the injection site. The subject was seen at a physician's office and was prescribed ibuprofen At the time of initial reporting, 18, December 2006, the event was ongoing and the healthcare professional reported that the injection site pain, has lasted for a week.  The healthcare professional considered the event was probably related to vaccination with Fluarix.				Y					N	12/07/2006				OTH	OTH		unknown	This subject's medical history, concurrent conditions, and concurrent medications were not reported. The healthcare professional reported that 2 other subjects experienced injection site pain following receipt of Fluarix. Please see cases A0631984A.	This vaccine had no adverse events following receipt of prior immunizations of influenza virus vaccine.~ ()~~0.00~In Patient	A0631988A	1						1	Fall; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0275525	04/03/2007	CA	43.0	13		F	03/21/2007	This case was reported by a healthcare professional and describe the occurrence of injection site pain in a 43 year old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis, The reporter is the subject. Concurrent medications included Thyroxine sodium (Synthroid). On an unspecified date in 2005, the subject received unspecified dose of Fluarix. On an unspecified date in 2005, less than one year after vaccination with Fluarix, the subject experienced injection site pain. The injection site pain resolved on an unspecified date before 03, November 2006. On 03, November 2006 the subject received another dose of Fluarix in the left arm. On 03, November 2006 the subject also received vaccination with meningococcal vaccine (unspecified, non-GSK manufacturer). The site of administration of the meningococcal vaccine was not provided. On an unspecified date in 2006, on or after 03, November 2006 and on or before 18, December 2006, less than one year after vaccination with Fluarix, the subject again experienced pain at the injection site of Fluarix. The injection site pain resolved on an unspecified date on or after 03, November 2006 and on or before 18, December 2006. The professional considered the events were probably related to vaccination with Fluarix.									Y	11/03/2006				PVT	PVT		unknown	This subject's medical history, concurrent conditions, and concurrent medications were not reported. The healthcare professional reported that 2 other subjects experienced injection site pain following receipt of Fluarix. Please see cases A0631984A and A0631988A.	This vaccinee experienced injection site pain following receipt of a prior dose of Fluarix~ ()~~0.00~Patient	A0631989A	1						1	Injection site pain; Vaccine positive rechallenge	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUARIX)~1|MEN~UNKNOWN MANUFACTURER~~UNK~~~MENINGOCOCCAL (NO BRAND NAME)~1	USA		Influenza
0275526	04/03/2007		32.0			F	03/21/2007	This case was reported by a consumer and described the occurrence of rash in a 32 year old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) and later her spouse was vaccinated with influenza virus vaccine for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medical conditions included drug allergy to gentamician. In November 2006, the subject received unspecified dose of Fluarux (unknown) and experienced rash and itching. Treated with Benadryl. events resolved within two weeks. On 09, December 2006 the subject's husband received unspecified dose of Influenza virus vaccine (manufacturer unknown). The reporter stated that the following day she had intercourse with her husband and she began to experience rash and itching on her back. legs and chest like she did following her vaccination with Fluarix. The reporter stated that she believed that she may have had a reaction from her husband's bodily fluids which may have carried gentaician into her system form the flu vaccine. She received treatment with diphenhydramine hydrochloride (Benadryl). At the time of reporting the outcome of the events were unresolved. she considered that the events jeopardized/required intervention.									U		12/10/2006			OTH	OTH		Drug allergy	Allergic to gentamician		A0632142A	1						1	Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0275527	04/03/2007	NC	60.0			F	03/21/2007	This case was reported by a pharmacist and described the occurrence of injection site soreness in a 60 year old female subject who was vaccinated wit influenza virus vaccine (Influenza vaccine, manufacturer unspecified) for prophylaxis. On an unspecified date in December 2006 the subject received unspecified dose of Influenza vaccine in the right arm. On an unspecified date in December 2006, less than one month after vaccination with Influenza vaccine, the subject experienced injection site soreness, and soreness to the top of the right arm and soreness to the lymph nodes under the right arm. At the time of initial reporting, 04, January 2007, the events were ongoing.									N				unknown	PVT	OTH		unknown	This subject's medical history, concurrent conditions, and concurrent medications were not reported		A0634355A	1						1	Injection site pain; Lymph node pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0275528	04/03/2007	NC	55.0	56		F	03/21/2007	This case was reported by a healthcare professional and described the occurrence of cough in a 55 year old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. Previous and /or concurrent vaccination included hepatitis A vaccine (Havrix); GlaxoSmithKline given on 4, January 2007. concomitant medications were not provided. On 4, January 2007 the subject received and unspecified dose of Fluarix (.5 ml, unknown, left arm). On 6, January 2007  2 days after vaccination with Fluarix, the subject experienced cough, watery eyes, sneezing, rhinitis, arm soreness and fatigue. She received no specific treatment for these events. The subject reported that she experiences cough watery eyes, sneezing, rhinitis, soreness in arm, and fatigue once or twice a year, even without vaccination. On 8, January 2006 the events were resolved. Follow-up received on 01, February 2007: The events resolved on 19, January 2007. The reporting healthcare professional considered the events were possibly related to vaccination with Fluarix.									Y	01/04/2007	01/06/2007	2	unk	OTH	PVT		unknown	This subject reported that she experiences cough, watery eyes, sneezing, rhinitis, soreness in arm, and fatigue once or twice a year, even without vaccination. The subject's medical history included obesity, osteoarthritis, and sleep apnea.	The subject experienced cough, sneezing, rhinitis, soreness, watery eyes. and fatigue with previous flu shots.~ ()~~0.00~In Pati	A0634830A	1						1	Cough; Fatigue; Lacrimation increased; Pain in extremity; Rhinitis; Sneezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA223AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0275529	04/03/2007	WA	25.0			F	03/21/2007	This case was reported by a nurse via a sales representative and described the occurrence of injection site pain in a 25 year old female subject who was vaccinated with FLUARIX, GlaxoSmithKline. On an unspecified date on or prior to 17, January 2007, the subject received unspecified dose of FLUARIX (0.5 ml, unknown, right arm). On 18 October 2006 after vaccination with FLUARIX, the subject experienced injection site pain, joint stiffness and unable to raise arm. At the time of reporting the outcome of the events was unspecified. Follow-up information received - The events completely resolved by 18 November 2006. In the reporter's opinion, the events were possibly related to treatment with FLUARIX.									Y		10/18/2006		UNK	PVT	PVT	Not reported	Unknown Not reported	The subject's medical history, concurrent conditions, and concurrent medications were not reported. The reporting nurse also reported 4 other subjects who experienced pain at injection site, joint stiffness and unable to raise arm. See case id numbers: A0635910A, A0635911A, A0635912A, and A0635913A.		A0635908A	1						1	Injected limb mobility decreased; Injection site pain; Joint stiffness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA22UBA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0275530	04/03/2007	WA				U	03/21/2007	This case was reported by a nurse via a sales representative and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with influreza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On an unspecified date on or prior to 17, January 2007, the subject received unspecified dose of Fluarix (0.5 ml, unknown, right arm). On an unspecified date after vaccination with Fluarix, the subject experienced injection site pain, joint stiffness and unable to raise arm. At the time of reporting the outcome of the events was specified.									U					PVT	PVT		unknown	The subject's medical history, concurrent conditions, and concurrent medications were not reported. The reporting nurse also reported 4 other subjects who experienced pain at injection site, joint stiffness and unable to raise arm. See case id numbers: AO635908A, A0635911A, A0635912A, A0635913A.		A0635910A	1						1	Injected limb mobility decreased; Injection site pain; Joint stiffness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0275531	04/03/2007	WA				U	03/21/2007	This case was reported by a nurse via a sales representative and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On an unspecified date on or prior to 17, January 2007, the subject received unspecified dose of Fluarix (0.5 ml, unknown, right arm). On an unspecified date after vaccination with Fluarix, the subject experienced injection site pain, joint stiffness and unable to raise arm. At the time of reporting the outcome of the events was unspecified.									U					PVT	PVT		unknown	The subject's medical history, concurrent conditions, and concurrent medications were not reported. The reporting nurse also reported 4 other subjects who experienced pain at  injection site, joint stiffness and unable to raise arm. See case id numbers: A0635908A, A0635910A, and A0635913A.		A0635911A	1						1	Injected limb mobility decreased; Injection site pain; Joint stiffness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0275532	04/03/2007	WA				U	03/21/2007	This case was reported by a nurse via a sales representative and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On an unspecified date on or prior to 17, January 2007, the subject received unspecified dose of Fluarix (0.5 ml, unknown, right arm). On an unspecified date after vaccination with Fluarix, the subject experienced injection site pain, joint stiffness and unable to raise arm. At the time of reporting the outcome of the events was unspecified.									U					PVT	PVT		unknown	The subject's medical history, concurrent conditions, and concurrent medications were not reported. The reporting nurse also reported 4 other subjects who experienced pain at  injection site, joint stiffness and unable to raise arm. See case id numbers: A0635908A, A0635910A, and A0635913A.		A0635912A	1						1	Injected limb mobility decreased; Injection site pain; Joint stiffness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0275533	04/03/2007	WA				U	03/21/2007	This case was reported by a nurse via a sales representative and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On an unspecified date on or prior to 17, January 2007, the subject received unspecified dose of Fluarix (0.5 ml, unknown, right arm). On an unspecified date after vaccination with Fluarix, the subject experienced injection site pain, joint stiffness and unable to raise arm. At the time of reporting the outcome of the events was unspecified.									U					PVT	PVT		unknown	The subject's medical history, concurrent conditions, and concurrent medications were not reported. The reporting nurse also reported 4 other subjects who experienced pain at  injection site, joint stiffness and unable to raise arm. See case id numbers: A0635908A, A0635910A, AO635911A and A0635913A.		AO635913A	1						1	Injected limb mobility decreased; Injection site pain; Joint stiffness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0275534	04/03/2007	MI	45.0	45		F	03/21/2007	This case was reported by a healthcare professional and described the occurrence of sore arm in a 45 year old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. The subject had not previously received an influenza virus vaccine. The subject had not previously received an influenza virus vaccine immunization. On 16, November 2006 at 8;36 p.m the subject received a dose of Fluarix in an unspecified arm. On an unspecified date on or after 16, November 2006, less than one week after vaccination with Fluarix, the subject experienced injection site redness, heat at injection site. and her entire arm was sore. The subject was seen at a physician's office. The healthcare professional reported that,  the patient's doctor stated that she may be allergic to the preservative in the vaccination. The events resolved in approximately one week on an unspecified date in 2006. The healthcare professional considered the events were probably related to vaccination with Fluarix. Follow-up information received on 26 February 2007 indicated that the events began on 17, November 2006, the day after vaccination with Fluarix. The events completely resolved by 24, November 2006. An additional event of arm swelling was reported. In the reporter's opinion, the events were related to treatment with Fluarix.				Y					Y	11/16/2006	11/17/2006	1		OTH	PUB		unknown	The subject's medical history, concurrent conditions, and concurrent medications were not reported.		A0636175A	1						1	Injection site erythema; Injection site warmth; Pain in extremity; Reaction to preservatives	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA242HA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0275535	04/03/2007	WA				U	03/21/2007	This case was reported by a healthcare professional and described the occurrence of unspecified adverse reaction in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Flu vaccine, manufacturer unspecified) for prophylaxis. On an unspecified date, approximately four years ago, the subject received unspecified dose of Flu vaccine (unknown) and experienced an unspecified adverse reaction in 2001. The healthcare professional reported that the subject reacted to the neomycin component of the flu vaccine. At the time of reporting the outcome of the event was unspecified.														OTH	OTH		unknown			A0636738A	1						1	Vaccination complication	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0275536	04/03/2007	MD	29.0	29		F	03/21/2007	This case was reported by a physician and described the occurrence of hives in a 29 year old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. The subject's medical history included exposure to tuberculosis and penicillin allergy - urticaria. Concurrent medications included Ortho Tri-Cyclen (Orthotricyclen), Pantoprazole (Protonix), Methylphenidate hydrochloride (Ritalin)Methylphenidate hydrochloride (Concerta) and pyridoxine hydrochloride (Vitamin B6). Concurrent medication also included 9 months of Isoniazid therapy which will conclude in May 2007. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On 19, October 2006 at 12:00 p.m., the subject received unspecified dose of Fluarix in the left arm. the evening of  19, October 2006, less than one day after vaccination with Fluarix, the subject experienced hives and itching all over her body and angioedema. The physician considered the events were life threatening and clinically significant (or requiring intervention). The subject was treated with diphenhydramine (Benadryl). Approximately one month after receipt of Fluarix, on an unspecified date in November 2006, the subject was seen by an physician for skin testing. The skin testing revealed positive skin reactions to Fluarix and to gentamicin. The physician stated that the subject cannot recall ever having an exposure to gentamicin and that gentamicin is, contained within Fluarix. The events resolved on an unspecified date on or before 24, January 2007. Follow-up was received from the reporting physician on 09, February 2007. Medical history also included non-smoker and non-drinker. The event of angioedema was clarified to facial and laryngeal edema. The events resolved on 20 October 2006. The physician considered the events to possibly be related to vaccination with Fluarix.				Y					Y	10/19/2006	10/19/2006	0	Test: November 2006: Skin testing revealed a positive skin reaction to Fluarix and to gentamicin.	OTH	OTH	Isoniazid, Ortho tri-Cyclen, (Ethinyloestradiol + Norgestimate + Oral contraceptive placeb) Pantoprazole, Methylphenidate HC1, Methylphenidate HC1, Pyridoxine hydrochloride	unknown	Exposure to Tuberculosis, non-drinker, nonsmoker, penicillin allergy - urticaria. The subject's concurrent conditions were not reported	This vaccinee had no adverse events following receipt of prior immunizations of influenza virus vaccines~ ()~~0.00~In Patient	A0636749A	1						1	Angioedema; Drug hypersensitivity; Face oedema; Laryngeal oedema; Pruritus generalised; Skin test positive; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0275537	04/03/2007	CA	54.0	54		F	03/21/2007	This case was reported by a healthcare professional and described the occurrence of raised red lump at injection site in a 54 year old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. Concurrent medical conditions included drug allergy, high blood pressure, hypothyroidism and subdural hematoma. The subject smoked 1/2 pack a day and did not drink alcohol. concurrent medications included phenytoin (Dilantin), Thyroxine sodium (Levothyroxine and Atenolo1. On 17, October 2006 at 14:30 the subject received unspecified dose of Fluarix intramuscularly in the right deltoid. A day later, on 18, October 2006, the subject developed an almond sized, red, swollen, hard, painful lump at the injection site. Then the area became blistered. The subject developed fever blisters on her nose and lips. a stuffy head and nose and had head congestion. The subject physician advised her never to get the flu vaccine again. At the time of reporting the outcome of the events was unspecified. Follow-up information was received from the healthcare provider on 03 April 2007. According to follow-up, the subject received flu vaccine (unspecified manufacturer) in past years. Four years ago, she had soreness at injection site at unspecified time after receiving the flu vaccine. It was also reported that the subject had soreness at injection site previous years. The outcome of the soreness at injection site was not provided. With events that subject experienced on 18 October 2007, the healthcare profesional reported diagnosis as a vaccine reaction. The vaccine reaction and associated symptoms resolved on an unspecified date. The reporter considered it possible that the vaccine reaction was related to vaccination with FLUARIX. Treatment included unspecified antibiotics on four occasions for respiratory and/ or sinus since receiving vaccination with FLUARIX. The FLUARIX was not reintroduced to the subject.									U	10/17/2006	10/18/2006	1		PVT	PVT	Thyroxine Sodium, Phenytoin, Atenolol	Drug allergy, high blood pressure, hypothyroidism, subdural hematoma	The subject has a history of allergy to penicillin, sulfa, codeine and hydrochlorathiazide.		A0638390A	1						1	Injection site erythema; Injection site induration; Injection site mass; Injection site pain; Injection site swelling; Injection site vesicles; Nasal congestion; Oral herpes; Upper respiratory tract congestion	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA213BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0275538	04/03/2007	OH	40.0	40		F	03/21/2007	This case was reported by a pharmacist and described the occurrence of injection site redness in a 40 year old female subject who was vaccinated with influenza virus (Fluarix, GlaxoSmithskline) for prophylaxis. The subject's medical history included allergy to nsaids, cellulitis, dyspareunia,dysthymia, gastroesophageal reflux disease, hyperlipidemia, knee osteoarthritis and neck abscess. Concurrent medications included Moxifloxacin hydrochloride (Moxifloxacin), Rosuvastatin, calcium (Crestor), Vicodin, Lormetazepam, Omeprazole (Prilosec), Nortriptyline, Trazodone and Capsaicin (Capsaicin cream). The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On 29, January 2007 the subject received unspecified dose of Fluarix in the right deltoid. On 29, January 2007, the subject also received and administration of tetanus and diphtheria toxoids adsorbed (Adventis Pasteur) at an unspecified site of injection. On 01, February 2007, 3 days after vaccination with Fluarix, the subject experienced redness and hardening at the injection site of Fluarix in an area if 8 mm,  chest pain, chest congestion, and vomiting. The redness and hardening at the injection site resolved on 06 February 2007. On 12 February 2007, the subject was seen at a physician's office and the chest pain , chest congestion and vomiting were resolved. The pharmacist considered the events were possible related to vaccination with Fluarix. Follow-up information received on 26, February 2007 indicated that the event actually resolved by 06 February 2007 as opposed to the originally reported date of 12 February 2007. The events were not considered to be life threatening. A history of smoking , 1 pack per day was reported. No additional information was reported.				Y					Y	01/29/2007	02/01/2007	3		MIL	PUB	Moxifloxacin HCL, Rosuvastatin calcium, Vicodin (Hydrocodone bitartrate + Paracetamol), Lorazepam Omeprazole, Nortriptyline, Trazodone, Capsaicin	unknown	Allergy to NSAIDS, cellulitis, dyspareunia, dysthymia, gastroesophageal reflux disease, hyperlipidemia, knee osteoarthritis, neck abscess. The subject's concurrent conditions were not reported. Smoker, 1 pack per day.	This vaccine had no adverse events following receipt of prior immunizations of influenza virus vaccine.~ ()~~0.00~In Patient	A0639618A	1						1	Chest pain; Injection site erythema; Injection site induration; Upper respiratory tract congestion; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA244AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0275539	04/03/2007					U	03/21/2007	This case was reported by a pharmacist and described the occurrence of mental status changes in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Influenza vaccine, manufacturer unspecified) for prophylaxis. There were no concurrent medications. On an unspecified date before 15, February 2007, the subject received unspecified dose of Influenza vaccine. At an unspecified time after vaccination with Influenza vaccine. On an unspecified date on or before 15, February 2007, the subject experienced mental status changes. At the time of initial reporting, 15, February 2007, the event was ongoing									N					OTH	OTH	No concurrent medication	Unknown	The subject's medical history and concurrent conditions were not reported.		A0639752A	1						1	Mental status changes	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0275540	04/03/2007					F	03/21/2007	This case was reported by a consumer and described the occurrence of erythema of leg in an adult female subject who was vaccinated with influenza virus vaccine (Flu vaccine, manufacturer unspecified for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medical conditions included egg allergy. On an unspecified date, 50 years ago when the subject was a child, she received an unspecified dose of Flu vaccine (unknown) At an unspecified time after vaccination with Flu vaccine, both the subject's legs became beet red The subject did not recall who made the Flu vaccine she received and did not recall any further information about the incident. At the time of reporting, the outcome of the event was specified.									U					OTH	OTH		Egg allergy			A0640142A	1						1	Erythema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0275541	04/03/2007					U	03/21/2007	This case was reported by a physician and described the occurrence of anaphylactic reaction in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Flu vaccine) for prophylaxis. On an unspecified date, 30 to 40 years ago, the subject received unspecified dose of Flu vaccine and experienced and anaphylactic reaction. This case was assessed as medically serious by GSK. At the time of reporting the event was resolved.									Y				UNK	OTH	OTH		unknown			A0640328A	1						1	Anaphylactic reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0275597	04/04/2007	SC	53.0	53		F	04/04/2007	10/20/2006: Immediately after receiving flu shot, left arm went heavy and limp with a dull ache-like pain.  Left arm remained so uncomfortable that unable to sleep on left side for several days.  The severe pain eased after approxiamtely 3 days.  Afterwards the injection site remained sore for weeks.  Patient noticed that when she moved her left arm to various positions, she could still feel the heavy, limp-like feeling all the way down her left arm. Currently (April, 2007) when she raises her left arm and places it in a backward position, the pain is elicited lasting for 20-35 seconds and then it goes away.  During this time, patient expresses no strength in her arm. SPECIAL NOTE: the vaccine received was given on 10/20/06 and was part of the Fluvirin recalled lot.  Patient was revaccinated on 11/08/06 and did not experience any problems from the second influenza immunization.									N	10/20/2006	10/20/2006	0	NONE	PUB	PUB	HCTZ 25 mg daily	NONE	Hypertension, anemia		SC0633	1						1	Asthenia; Injection site pain; Pain; Pain in extremity; Sensation of heaviness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71209~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0275611	04/04/2007	AK	2.0	2	.7	F	04/04/2007	Patient developed hives the day after receiveing vaccinations. Began on lower extremeities and spread to her upper chest. Afebrile. Otherwise feeling fine. Benedryl provided relief. Symptoms had improved after 4 days, althou some hives were still present. Patient was adopted from another country, childhood immnuizations were documented as being received, but when titers were drawn, pt was found not immune, therfore repeat vaccinations are being provided per pediatricians recommendations.									Y	03/22/2007	03/23/2007	1	None performed	UNK	UNK	None that I'm aware of	No known illness	None that I'm aware of.			1						1	No reaction on previous exposure to drug; Urticaria; Vaccination failure	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B070BA~5~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2175GA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0406F~1~IM~LL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08684K~1~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0275617	04/04/2007	NY	1.59	1	.6	M	04/04/2007	Maculo Papulo vesicular rash on vaccine administration site approximately 6 days post administration.  4/6/07 Received medical records from PCP which reveal patient experienced mild URI symptoms on 3/27/07 day of vax.  Vaccination record included. 5/4/07 Received medical records from hospital which reveal patient experienced erythematous rash w/pain & pruritis on left thigh & gluteus, macular vesicular apulae in appearance.  Admitted 4/3-4/5/07.  Tx w/IV antibiotics for initial cellulitis.  Dermatology & Allergology consults done.   Temp in hospital 102.9 FINAL DX: Herpes zoster left leg.				Y	Y	3			Y	03/27/2007	04/02/2007	6	G 34% L 45% E 6% WBC 6.2 Hbg 11.9, Hct 35.7, Platelet count 385	PVT	OTH	None	None	Eczema PMH: Eczema.  Patient had prior similar reaction after vaccines in 9/06.			1						1	Haematocrit normal; Haemoglobin normal; Injection site rash; Platelet count normal; Rash maculo-papular; Rash vesicular; White blood cell count normal	DTAP~UNKNOWN MANUFACTURER~~UNK~IM~~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~IM~~HEP A (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~UNK~IM~~HIB (NO BRAND NAME)~1|PNC~PFIZER\WYETH~~UNK~IM~~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0275649	04/05/2007	NY	1.29	1	.3	M	03/30/2007	Patient developed papular rash on lower and upper body and a temp of 101.9. Pt received Tylenol and a CBC was taken. Rash appeared 7 days after vaccination.				Y					Y	03/07/2007	03/15/2007	8	Complete Blood count	PUB	PUB	None	Rash with fever	Down syndrome			1						1	Body temperature increased; Full blood count; Rash papular	FLU3~SANOFI PASTEUR~UT2175CA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0383R~1~~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0636R~1~~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0273181	04/06/2007	WV	0.54	0	.5	M	04/03/2007	Initial information received on 28 March 2007 from another manufacturer, report number WAES0702USA03484. The initial reporter to this manufacturer has been a health care professional. Information has been received from a pediatrician concerning a 6 month old white male, with a possible history of reflux, who on the morning of 12-FEB-2007 was vaccinated PO with the third 2.0 mL dose of Rotateq (Lot # 656105/1232F). Concomitant vaccines administered on the same day included a third dose in the right anterior thigh of PEDIARIX (Lot# AC21B097AB), a third dose in the left anterior thigh of PREVNAR (B036258B) and a first dose in the right anterior thigh of FLUZONE (Lot# U2285AA). There was no illness at the time of vaccination and no adverse events following prior vaccination. The physician reported that on the night of 15-FEB-2007, the patient developed hematochezia and was taken to the Emergency Room (ER). The patient's stool tested positive for rotavirus (type not known). The patient was subsequently released from the ER. On 16-FEB-2007, the patient was seen by the pediatrician. No further sequelae was noted as the patient was considered to be fully recovered. Follow-up information from a pediatrician via medical records indicated that on 15-FEB-2007 the patient reported to the emergency room via a private vehicle. There, the patient's mother stated that the child had three episodes of diarrhea which all contained a slight bit of which looked to be blood. The patient's mother contacted her pediatrician's office and the answering service directed her to come to the emergency room stating that it could have possibly been a reaction to the immunizations that she just received, which was Rotateq, which she just had her third dose on 12-FEB-2007. The patient had been fine all week, however on that day she had a little bit of mucous and blood in her stool, a low grade fever, and was also acting quite fussy. The patient started with a small cough and started with a rash since she had been there. During the course in the emergency room, a positive heme occult from the patient's diaper was obtained that was presented to the mother that did show some tiny specks of blood. The patient was positive rotavirus via a rectal swab, and had mild diarrhea. The patient was well after this. There was no severe belly pain or intussusception. The patient was seen in the pediatrician's office for follow up on 16-FEB-2007, and had recovered.  Upon internal review, hematochezia was determined to be an other important medical event. Additional information is not expected.				Y					Y	02/12/2007	02/15/2007	3	16/Feb/2007: stool clostridium-negative; WBC 17.2 K/cu; 15/Feb/2007: stool rotavirus antigen-positive	PVT	PVT			The patient had a history of possible reflux.		200700968	1						2	Haematochezia; Rotavirus test positive; Clostridium difficile toxin test; Cough; Diarrhoea; Diarrhoea haemorrhagic; Haematochezia; Irritability; Mucous stools; Occult blood positive; Pyrexia; Rash; Rotavirus test positive; White blood cell count increased	RV5~MERCK & CO. INC.~1232F~3~PO~MO~ROTAVIRUS (ROTATEQ)~1|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B097AB~3~~RL~DTAP + HEPB + IPV (PEDIARIX)~2|FLU3~SANOFI PASTEUR~U2285A~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|PNC~PFIZER\WYETH~B36258B~3~~LL~PNEUMO (PREVNAR)~2|RV5~MERCK & CO. INC.~1232F~3~PO~MO~ROTAVIRUS (ROTATEQ)~2	USA	Emergency room visit	Influenza
0275733	04/06/2007	NC	11.0	11		M	04/06/2007	Pt returned to facility two days after his vaccinations with hives on both legs.  Mother stated it had started yesterday and was not spreading any more.  No difficulty in breathing.									Y	04/03/2007	04/04/2007	1		MIL	MIL	none	none	none			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2308AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1209F~1~IM~LA~HEP A (VAQTA)~1|MNQ~SANOFI PASTEUR~U1974AB~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B004AB~1~IM~RA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1300F~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0275749	04/06/2007	PA	92.0	91		F	03/30/2007	A 91 yr old presented to the ER with painful paresthesia of both feet, abrupt onset of difficulty with ambulation, subjective weakness and incoordination of both lower extremities and back pain. Neurology felt abrupt onset of symptoms precluded a diagnosis of Guillain Barre syndrome. Patient received a flu shot in late January and the timing suggests that was the initiating source of GBS.  5/1/07 Received medical records from hospital which reveal patient experienced painful paresthesia of both feet up to ankles, intrascapular back pain, weakness & difficulty walking for 1-2 days.  Admitted 2/10/07-2/22/07 for ataxia.  Had persistent HTN while hospitalized & a heart murmur.  Consults by neuro, pulmonary, surgery, nephrology, physical med.  Tx w/plasma phoresis x 5 which did improve sensorimotor function & was able to ambulate w/walker at d/c to inpatient rehab facility where she stayed from 2/22-3/16/07 when she was d/c to home with continued home health care.  FINAL DX: Guillain Barre Syndrome.					Y	34			Y	01/01/2007	02/10/2007	40	LABS: EKG was WNL.  CT of head was WNL.  LS spine series revealed DDD.  WBC peak 21.8.    Echocardiogram revealed mild LVH.  Carotid Doppler revealed mild stenosis of carotid arteries.  Doppler of all extremities was neg.  LP revealed CSF was abnormal.	UNK	UNK			Osteoporosis, hypertension, borderline diabetes.  PMH: HTN, osteoporosis, mild obesity, borderline diabetes.			1						1	Asthenia; Back pain; Coordination abnormal; Gait disturbance; Guillain-Barre syndrome; Neurological examination abnormal; Pain in extremity; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0275752	04/06/2007	CA	1.11	1	.1	M	03/15/2007	Gave IPV#4 that isn't due til age 4 years of age didn't give MMR or Varivax, Hep B and were out of Hep A.									U	01/17/2007				PUB	PUB	None				CA070012	1						1	Inappropriate schedule of drug administration; Medication error	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B0843A~UNK~~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~42913A~UNK~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF016AA~UNK~~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B08074~UNK~~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0275754	04/06/2007	MA	51.0	50		F	04/08/2007	Itchy skin at injection site gave her Benadryl 25mg PO x 1 dose.									Y	10/18/2006	10/18/2006	0		OTH	OTH		None	PCN			1						1	Injection site pruritus	FLU3~SANOFI PASTEUR~U2165EA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0275755	04/06/2007	MA	50.0	50		F	04/08/2007	Itchy skin at injection site gave her Benadryl 25mg PO x 1 dose.									Y	10/18/2006	10/18/2006	0		OTH	OTH		None				1						1	Injection site pruritus	FLU3~SANOFI PASTEUR~U2165EA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0269349	04/09/2007	MN	5.0	5		M	04/04/2007	Information has been received from a physician and a licensed practical nurse concerning a 5 year old white male who on 04, Dec 2006 at 11:30 was vaccinated SC in the right lower thigh with a first dose of measles virus vaccine live (Enders-Edmonston) (-) mumps virus vaccine live (Jeryl Lynn) (-) rubella virus vaccine live (Wistar Ra 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (lot # 655746/1093F). Concomitant vaccination on the same day at the same time included a fifth dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (-) tetanus toxoid (INFANRIX) lot # AC14B035AA) given IM in the left upper thigh, a fourth dose of poliovirus vaccine inactivated (vero) (IPOL) (lot # A0240) given SC in the left lower thigh and a second dose of influenza virus split virion 3v vaccine inactivated (FLUZONE) lot 3 U2244AA) given IM in the right upper thigh. The next day, on the evening of 05, Dec 2006 at 21:51 the patient woke up with hives on his face and neck. Medical attention was sought and the patient was treated with diphenhydramine hydrochloride (BENADRYL). The patient's mother also reported that his left thigh had redness which lasted two days. Subsequently, on 13, Dec 2006 the patient also broke out on his left thigh with a 2-3 inch area of confluent lesions that appeared as a pink red bumpy rash with a raised border. The patient was reported to have a similar rash on his right thigh that was about 1x1 inch. It was reported that the patient was vaccinated in the past with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) without experiencing any adverse reactions. The patient's records also indicated that he was previously vaccinated with diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (INFANRIX), poliovirus vaccine inactivated (Vero) (IPOL) and influenza virus split virion 3v vaccine inactivated (Fluzone with no adverse reaction. There was no product quality complaint involved. No additional information was provided.				Y					Y	12/04/2006	12/05/2006	1	Unknown	PUB	OTH			unknown		WAES0612USA02645	1						2	Injection site erythema; Injection site rash; Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B035AA~5~IM~~DTAP (INFANRIX)~2|FLU3~SANOFI PASTEUR~U2244AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|IPV~SANOFI PASTEUR~Z0240~4~SC~~POLIO VIRUS, INACT. (IPOL)~2|MMRV~MERCK & CO. INC.~655746/1093F~1~SC~~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~2	USA	Emergency room visit	Influenza
0270508	04/09/2007	KY	12.0	1	.0	M	04/04/2007	Information has been received from a registered nurse concerning a 12 month old male with a history of bilateral ear tube insertion (12, Dec 2006) with no known drug allergies or reactions, who on 02, Jan 2007 was vaccinated subcutaneously in the right arm with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (lot # 655847/1386F). Concomitant therapy included the fourth dose of pneumococcal 4 6B 9V 16 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (lot# B08670K)  intramuscularly in the left thigh, the first dose of hepatitis A vaccine (inactive) (MSD) (lot #  656497/1213F) intramuscularly in the right thigh and the second dose of influenza virus split virion 3v vaccine inactivated (FLUZONE) (influenza virus split virion 3v vaccine inactivated ) (lot # UT2174LA) intramuscularly in the right thigh on 10, Jan 2007. the patient had a fever of 101; noted to last two days (onset of symptoms also noted as 11, Jan 2007. Medical attention was sought on 12, Jan 2007, during a doctor's office visit loss of appetite, loose stools, and three vesicular lesions (one hard, one on his back, and one on his trunk) were noted; the diagnosis was mild chicken pox secondary to vaccine. No additional information to report. There was no product quality complaint.				Y					Y	01/02/2007	01/10/2007	8	body temp, 01/10/2007, fever	PVT	PVT			Ear tube insertion		WAES0701USA01909	1						2	Decreased appetite; Diarrhoea; Pyrexia; Rash vesicular; Anorexia; Body temperature; Diarrhoea; Pyrexia; Rash vesicular; Varicella; Varicella post vaccine	FLU3~SANOFI PASTEUR~UT2174LA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1213F~1~IM~RL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~1386F~1~SC~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08670K~4~IM~LL~PNEUMO (PREVNAR)~1|FLU3~SANOFI PASTEUR~UT2174LA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~MERCK & CO. INC.~656497/1213F~1~IM~~HEP A (VAQTA)~2|MMRV~MERCK & CO. INC.~655847/1386F~1~SC~~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~2|PNC~PFIZER\WYETH~B08670K~4~IM~~PNEUMO (PREVNAR)~2	USA	Emergency room visit	Influenza
0274946	04/09/2007	NH	7.0			F	04/04/2007	Initial report received on 28 March 2007 from an other manufacturer, reference number WAES 0703USA02777. This manufacturer received the original report from a nurse. Verbatim from the report: Information has been received from a registered nurse concerning a 7-year-old female with asthma and allergies to Zithromax, cyprohetadine, beef, corn, soy, and milk, chronic gastric paresis, eosinophilic, and esophagitis who on 26-FEB-2007 at 4:30 PM was vaccinated SC in the right arm with a second dose of Varivax (Lot # 656079/1306F). Concomitant therapy that day at 4:30 PM included a forth dose of Fluzone (Lot # U62271AA) (not a valid lot number) administered in the right deltoid. Additional concomitant therapy included montelukast sodium, Flovent, Prevacid, Miralax, and vitamins (unspecified). On 26-FEB-2007 at 5:45 PM, the patient's whole body became bright red, and the child became itchy and warm with hives. In addition, the patient's eyes started to swell. After talking to the doctor, 25mg Benadryl was given and was told to go to the ER. The patient began wheezing on the way to the ER. Epinephrine was given in the ER and the patient was discharged on prednisone. Subsequently, the patient recovered. There was no product quality complaint. The events were considered to be immediately life-threatening and other important medical events by the reporter. Additional information has been requested. The reporter for this case is the same as for case 2007-00972. Where a 4-year-old male experienced urticaria.			Y	Y					Y	02/26/2007	02/26/2006			PVT	PUB	FLOVENT, PREVACID, MIRALAX, VITAMINS, SINGULAIR		The patient had medical history of asthma, allergies to Zithromax, cyprohetadine, beef, corn, soy, and milk, chronic gastric paresis, eosinophilic, and esophagitis.		200700971	1						2	Erythema; Eye swelling; Pruritus; Skin warm; Urticaria; Wheezing; Erythema; Eye swelling; Pruritus; Skin warm; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U62271AA~4~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1306F~2~SC~RA~VARICELLA (VARIVAX)~1|FLU3~SANOFI PASTEUR~U62271AA~4~~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|VARCEL~MERCK & CO. INC.~1306F~2~SC~RA~VARICELLA (VARIVAX)~2	USA	Life Threatening	Influenza
0275798	04/09/2007	CA	11.0	11		F	04/09/2007	Hives occured 4 days after vaccine administration- itchy red bumps.									Y	02/05/2007	02/09/2007	4		PVT	UNK	Hydrocortisone					1						1	Pruritus; Rash erythematous; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MNQ~SANOFI PASTEUR~~UNK~~~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~~UNK~~~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~~UNK~~~VARICELLA (VARIVAX)~1	USA		Influenza
0275800	04/09/2007	MS	60.0	59		F	03/30/2007	CLIENT STATES THAT AFTER FLU INJ SHE BEGAN W/ C/O SHOULDER PAIN, BEING 'PARALYZED' AND 'NO FEELING ' IN l SHOULDER.  ALSO REPORTS THAT INJ SITE WAS RED AND WARM.  SAW PMD ON 11/01/06 AND REFERRED TO NEURO BUT ALL TESTING HAS BEEN NEGATIVE.  CONTINUES W/ C/O DIZZINESS AND SORENESS				Y					N	10/30/2006	10/30/2006	0	MRI, CT OF BODY	PUB	PUB	NORVASC, SYNTHROID, NEURONTIN, LOTREL	NONE	CODEINE, PENCILLIN, THYTOID, HYPERTENSION, ARTHRITIS/BURSITIS		MS07008	1						1	Injection site erythema; Injection site warmth; Musculoskeletal pain; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71826~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0275821	04/09/2007	MI	68.0	68		M	03/29/2007	9/28/06 shingles and Flu vaccine given separate arms. 10/30/06 wife called and stated 3-4 hrs after received vaccines pt didn't feel well, chills, teeth chattering, for 1/2 hrs, jumped out of chair, sweating, dripping water for 15 min. Bilateral shoulder and arm tingling 15 min wife thought from vaccines.									Y	09/28/2006	09/28/2006	0	Myoview stress done 11/3/06 due to appoint 10/30/06	PVT	PVT	Lopid, Dyazide, Toprol, Potassium, Fosamax, Rhinocort, Vit E, Calcium, Vit supp, Ultram prn	None	High chol, Hypertension, allergies, psoriasis, colon polyp, osteopenia,			1						1	Cardiac stress test; Chills; Hyperhidrosis; Malaise; Paraesthesia	FLU3~SANOFI PASTEUR~U2256AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~0981F~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0275822	04/09/2007	CT	1.51	1	.5	M	04/05/2007	Rash noted on cheeks and arms (flushing in appearance) went away in 2 minutes. Gave Benadryl and Tylenol and observed pt for 30 mins still had normal exam No rash 4/5/07									Y	04/04/2007	04/04/2007	0		PVT	PUB						1						1	Flushing; Rash	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B0474AA~4~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2220EA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1437F~3~IM~LA~HIB (PEDVAXHIB)~1	USA		Influenza
0275825	04/09/2007	KY	63.0	63		U		Injection Pneumococcal vaccine approx 3:15 PM checked out of Hosp 6:30 PM arm very sore by this time. Continued to get sore by 9:00 PM whole of arm extreme pain, real hot to touch, to painful to move throwing up, chills. Shoulder still hurts in joint.				Y					Y	02/23/2007	02/23/2007	0		PUB	UNK	Theo Dur, Aspirin, Premix Albuterol, Pulmicort	Acid Reflux	Allergy: Penicillin, Codeine, Ethyromycin, Avelox, Corn.			1						1	Arthralgia; Chills; Feeling hot; Hypokinesia; Pain in extremity; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0275832	04/09/2007	NJ	56.0			F	04/04/2007	Pt was seen by chiropractor 3 mo after pt received Flu vaccine and was diagnosed as to having shingles. Chiropractor said she had seen several similar situations recently.									N					PUB	PUB	See note attached	None	Asthma			1						1	Herpes zoster	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70739~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0275858	04/09/2007	PR	50.0	47		U		Ache bones, ache joints										11/04/2003				MIL	UNK						1						1	Arthralgia; Bone pain	ANTH~EMERGENT BIOSOLUTIONS~~UNK~~UN~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~~UNK~~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~ENG5444A4~UNK~~~HEP B (ENGERIX-B)~1|SMALL~UNKNOWN MANUFACTURER~4020074~UNK~~UN~SMALLPOX (NO BRAND NAME)~1	USA		Influenza
0275873	04/09/2007	FL	1.1	1	.1	M	04/04/2007	Information has been received from a certified medical assistant (C.M.A.) concerning a 1 year old male foster child and a history of being premature by 3 months and no allergies, who on 20, Dec 2006 was vaccinated subcutaenously with a 0.5 ml dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process)  (lot# 655314/0978F). Concomitant vaccinations given on the same day included: pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR), rotavirus G1 G2 G4 P1 reassortant vaccine live (human-bovine) (MSD), influenza virus vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. Eleven days post vaccination. On 01, Jan 2007 the patient developed an outbreak of chickenpox. The child had approximately 15 blisters noted on his forehead and feet/ankles. Unspecified medical attention was sought and no laboratory or diagnostic tests were performed. It was reported that the child had difficulty walking due to the blisters on the feet. No outcome was reported. No product quality complaint was involved. Additional information has been requested				Y					U	12/20/2006	01/01/2007	12	none	OTH	OTH		Wheezing	Premature baby; Foster care		WAES0701USA00725	1						1	Blister; Gait disturbance; Varicella	DPP~UNKNOWN MANUFACTURER~~UNK~~UN~DIPHTHERIA TOXOID + PERTUSSIS + IPV (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMRV~MERCK & CO. INC.~655314/0978F~UNK~SC~~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~~UNK~~UN~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~~UNK~~UN~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0271673	04/10/2007	CT	44.0	44		F		11/9-Flu shot-yellow mark on arm-slight pain, numb by morning each day numbness spread across left breast then down left side surface pain left breast and under breast. Changing to tightness under left breast numbness spreading to legs and feet over several weeks. Blood Tests, MRI's X-rays. 1/12/07-Numbness starts in left leg 1/12-diagnosis-Transverse Myelitis									U	11/09/2006	11/10/2006	1	MRI-Head, C-spine, Thoracic Spine, Blood work	PVT	OTH	None	None	None			1						2	Antinuclear antibody; Bacterial test negative; Demyelination; Hypoaesthesia; Muscular weakness; Myelitis transverse; Blood test; Chest discomfort; Discomfort; Hypoaesthesia; Injection site discolouration; Myelitis transverse; Nuclear magnetic resonance imaging; Pain in extremity; Spinal X-ray	FLU3~SANOFI PASTEUR~U2164AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2164AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0275900	04/10/2007	MD	0.7	0	.7	M	04/09/2007	Information has been received regarding a case in litigation concerning a 24 month old male who was injected with vaccines reportedly containing Thimerosal. It is alleged that between 12 and 25 micrograms of toxic ethylmercury were injected into the patient's body with each individual dose of Thimerosal and that the schedule of injections introduced a cumulative dose of 238 micrograms. It is further alleged that beginning approximately 13-NOV-1998, the patient began to display symptoms of neurological damage consistent with mercury poisoning, not limited to losing his language skills engaging in repetitive and stereotypical behaviors, suffering from diminished cognitive ability and becoming socially withdrawn. The patient has since been diagnosed as suffering with mercury poisoning and disintegrative (or late onset, degenerative or regressive) autism including severe, devastating and permanent neurological injuries. Follow up information has been received alleging that the patient was exposed to airborne vapors and mercury through the food chain, other mercury-laden products and power plant emissions. The patient was exposed to mercury from continually inhaling and ingesting industrial mercury emissions from fossil fuel driven power plants. The mercury included in the thimerosal-laden products and power plant emissions together caused the patient to suffer serious and permanent injuries, including mental, intellectual, developmental and neurological incapacity and associated learning disabilities, disorders and impairments. It is further alleged that the patient had a heightened vulnerability to suffer neurological injuries from industrial mercury as a direct result of thimerosal exposure. Additional follow up information indicated that the patient's family history is positive for allergic rhinitis and asthma. On 14-NOV-1996, 10-DEC-1996, and 13-AUG-1997 (Lot # 622792/E), the patient was vaccinated with the first, second, and third doses of hepatitis B vaccine. Other therapy included: globulin, immune (RHOGAM), DTP on 02-FEB-1997 (Lot 433-566), 19-MAR-1997 (444-251), 14-MAY-1997 (lot 444-259), 26-MAY-1998 (lot 453-844), and 14-SEP-2001 (lot 513A2); ACTHIB on 05-FEB-1997 (lot 433-566), 19-MAR-1997 (lot M035PE), 14-MAY-1997 (lot M30CPN), and 10-MAR-1998 (lot M285RJ); IPOL on 05-FEB-1997, 19-MAR-1997, 14-MAY-1997, and 14-SEP-2001; MMR II (lot 497814) on 19-NOV-1997; VARIVAX (lot 623130/0568E); and FLUSHIELD on 19-NOV-1997 (lot 497814) and 13-NOV-1998 (lot 20308). The first diagnosis of autism was noted to be July 1999. The patient was also noted to have neurodevelopment disorder. The autism and neurodevelopmental disorder was noted to be caused by thimerosal. Information received from medical records on 29-MAR-2007 contained the following adverse events: severe peanut allergy (2001), tree nut allergy; allergic rhinitis; mild persistent asthma; ear drainage (16-JUN-2000); recurrent ongoing otitis media (approximately January 1999); shellfish, strawberry, and grape jelly allergy. Upon internal review, autism, neurological injuries, serious and permanent injuries and mercury poisoning were considered to be other medical events. Additional information has been requested. All medical records are available upon request.									N	08/13/1997	11/13/1998	457	Unknown	OTH	OTH	Unknown		Unknown		WAES0208USA01250	1						1	Asthma; Autism; Cognitive disorder; Disturbance in social behaviour; Ear disorder; Food allergy; Learning disability; Metal poisoning; Nervous system disorder; Neurodevelopmental disorder; Otitis media; Psychomotor skills impaired; Rhinitis allergic; Social avoidant behaviour; Speech disorder; Speech disorder developmental; Stereotypy; Autism; Developmental delay; Metal poisoning; Neurodevelopmental disorder; Reaction to preservatives; Speech disorder; Abnormal behaviour; Asthma; Autism; Cognitive disorder; Developmental delay; Food allergy; Learning disability; Mental disorder; Mental impairment; Metal poisoning; Nervous system disorder; Neurodevelopmental disorder; Otitis media; Rhinitis allergic; Social avoidant behaviour; Speech disorder; Stereotypy	HEP~MERCK & CO. INC.~0321E~3~~UN~HEP B (RECOMBIVAX HB)~1|HIBV~PFIZER\WYETH~M285RJ~4~~UN~HIB (HIBTITER)~2|DTAP~UNKNOWN MANUFACTURER~453844~4~~~DTAP (NO BRAND NAME)~3|FLUX~UNKNOWN MANUFACTURER~497814~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|HEP~MERCK & CO. INC.~0312E~3~~~HEP B (RECOMBIVAX HB)~3|HIBV~SANOFI PASTEUR~M285RJ~UNK~~~HIB (ACTHIB)~3|IPV~SANOFI PASTEUR~~3~~~POLIO VIRUS, INACT. (IPOL)~3|MMR~MERCK & CO. INC.~497814~1~~~MEASLES + MUMPS + RUBELLA (MMR II)~3	USA		Influenza
0275922	04/10/2007	IN	31.0	31		M	04/10/2007	Pt with 8x6cm of erythema, 5x5cm of induration.  NOT ALL INFORMATION IS AVAILABLE.				Y					U	04/02/2007	04/03/2007	1	None	MIL	OTH	NONE	NONE	NONE			1						1	Erythema; Induration	ANTH~EMERGENT BIOSOLUTIONS~UNKNOWN~2~SC~LA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~UNKNOWN~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~UNKNOWN~2~IM~RA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0275933	04/10/2007	LA		5		M	04/10/2007	RASH AND ITCHING OVER FACE ARMS CHEST BACK. SEEN BY DR. 10ML OF BENADRYL GIVEN PO PER DR. DR. INSTRUCTED MOTHER TO GIVE ANOTHER DOSE IN 6 HRS. IF CHILD GET WORST TO GO TO THE HOSPITAL.  CHILD LEFT ABOUT 4:45 NAD.										04/09/2007	04/09/2007	0		UNK	UNK		NONE	NONE			1						1	Pruritus generalised; Rash generalised	FLU3~SANOFI PASTEUR~U2284AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1009F~2~IM~LA~HEP A (VAQTA)~1	USA		Influenza
0275942	04/10/2007	CA	29.0	29		F	10/11/2006	The place where I received my flu shot is very sore. It has been over 2 weeks and it is painful to lift my arm.									N	09/25/2006	09/27/2006	2	none	OTH	PVT	none	none	none			1						1	Injection site pain; Pain in extremity; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA201AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA201AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~2	USA		Influenza
0275943	04/10/2007	CA	36.0	36		F	10/27/2006	Dizziness on day of vaccine, 10/25/06 and also today. Muscle cramping evening of 10/26/06 and also today, lasted 90 min, today x 15 min heat, analgesic helped.									Y	10/25/2006	10/25/2006	0		PVT	PVT	BCP only	None	Allergic to milk and chocolate - stomach cramping lactose intolerance			1						1	Dizziness; Muscle spasms; Dizziness; Injection site warmth; Muscle spasms	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA216AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA216AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~2	USA		Influenza
0275944	04/10/2007	CA	32.0	32		F	10/30/2006	Swollen site, hot day after itchy a few days after and hot. Treated with heating pad to site, Tylenol for pain, with some improvement.									Y	10/27/2006	10/28/2006	1		PVT	PVT						1						1	Injection site pain; Injection site pruritus; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA216AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0275945	04/10/2007	CA	27.0	27		F	10/13/2006	Baseball size area of Redness, hot and painful radiates to L shoulder and down L arm.				Y					Y	10/11/2006	10/11/2006	0	None	PVT	PVT	BCP	None	Allergic to avocado, Canalope.			1						1	Erythema; Feeling hot; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA201AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0275946	04/10/2007	CA	46.0	45		F	10/07/2006	3 inch x 2 1/2 red area, hot, painful, tender				Y					Y	09/29/2006	10/01/2006	2	None	PVT	PVT	None	None				1						1	Erythema; Pain; Skin warm; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA201AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0275947	04/10/2007	CA	29.0	29		F	10/06/2006	Raised, red rash on bilateral arms, chest and top of feet. Rash is hot and itchy. DX as photo sensitive rash. Seen on 10/01/06 and 10/2/06. Prescribed Atarax 25 mg, 1-2 tabs PO 4 times per day prn, Hydrocortisone cream 1% BID, Methylprednisolone 4 mg as prescribed, descending doses x 6 days.				Y					Y	09/28/2006	09/28/2006	0	No labs done	PVT	PVT		None	Amoxicillin RXN 1990, allergic to Hosp soap, Uses Cetaphil soap.			1						1	Erythema; Photosensitivity reaction; Pruritus; Rash; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA201AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0275948	04/10/2007	CA	23.0	23		F	10/06/2006	No fever local left arm red from shoulder to elbow, swollen.				Y					Y	09/29/2006	09/29/2006	0	No labs done at med visit.	MIL	PVT	None	None	None			1						1	Injection site erythema; Oedema peripheral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA201AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0275954	04/10/2007	CA	4.0	4		F	03/25/2007	R arm swelling and redness with some pain after receiving Imm. Later that night, no fever or decreased ROM. Pt given RX for Artrax 8mg PRN. Taking Amoxicillin for OM									Y	02/23/2007			None	OTH	PUB		None	None			1						1	Erythema; Oedema peripheral; Pain in extremity	DTAP~SANOFI PASTEUR~C2407AA~5~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U22181AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y10512~4~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~1564F~2~SC~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0275955	04/10/2007	MI	1.03	1	.0	F	04/10/2007	Had shots At 3:30 PM. Woke up at 4 AM crying, with fever 104 rectal, both legs red, swollen. Mom gave Motrin at 5am, cool bath done. 7:30AM, crying and seizures - child appeared scared - jerked, shaking for about 5 mins. Mom took to Dr at 9 AM.				Y					N	04/09/2007	04/10/2007	1		PUB	PUB	None	None				1						1	Convulsion; Crying; Dyskinesia; Erythema; Fear; Oedema peripheral; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U2307AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0741F~1~IM~LL~HEP A (VAQTA)~1|HIBV~MERCK & CO. INC.~1014F~3~IM~RL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~1047R~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08684F~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0109U~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0275900	04/11/2007	MD		1	.3	U	04/10/2007	This case was considered medically important. Additional information pertaining to the reporting product, additional serious events, medical history, vaccines and dates of administration has been received. Information regarding Hib-Titer vaccine was received from an attorney regarding an 18-month-old patient who experienced autism, speech disorder, neurodevelopmental disorder, thimerosal toxicity and neurodevelopmental delay. The patient received the fourth dose on 10-Mar-1998. The patient developed autism in Jul-1999. On unspecified dated, the patient experienced thimerosal toxicity, neurodevelopmental delay, speech disorder and neurodevelopmental disorder. The outcome is unknown. No additional information was available at the time of this report.									U	03/10/1998	07/01/1999	478	Unknown	OTH	OTH	Unknown	Unknown	Unknown		HQ4238417SEP2002	1						2	Asthma; Autism; Cognitive disorder; Disturbance in social behaviour; Ear disorder; Food allergy; Learning disability; Metal poisoning; Nervous system disorder; Neurodevelopmental disorder; Otitis media; Psychomotor skills impaired; Rhinitis allergic; Social avoidant behaviour; Speech disorder; Speech disorder developmental; Stereotypy; Autism; Developmental delay; Metal poisoning; Neurodevelopmental disorder; Reaction to preservatives; Speech disorder; Abnormal behaviour; Asthma; Autism; Cognitive disorder; Developmental delay; Food allergy; Learning disability; Mental disorder; Mental impairment; Metal poisoning; Nervous system disorder; Neurodevelopmental disorder; Otitis media; Rhinitis allergic; Social avoidant behaviour; Speech disorder; Stereotypy	HEP~MERCK & CO. INC.~0321E~3~~UN~HEP B (RECOMBIVAX HB)~1|HIBV~PFIZER\WYETH~M285RJ~4~~UN~HIB (HIBTITER)~2|DTAP~UNKNOWN MANUFACTURER~453844~4~~~DTAP (NO BRAND NAME)~3|FLUX~UNKNOWN MANUFACTURER~497814~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|HEP~MERCK & CO. INC.~0312E~3~~~HEP B (RECOMBIVAX HB)~3|HIBV~SANOFI PASTEUR~M285RJ~UNK~~~HIB (ACTHIB)~3|IPV~SANOFI PASTEUR~~3~~~POLIO VIRUS, INACT. (IPOL)~3|MMR~MERCK & CO. INC.~497814~1~~~MEASLES + MUMPS + RUBELLA (MMR II)~3	USA		Influenza
0276055	04/11/2007					U		A report was received from a healthcare professional on 20/Oct/2006 concerning a 34 year old pregnant vaccinee. No details of the vaccinees past medical history or details of any concomitant medications were provided. On 13/Oct/2006 the vaccinee was administered Fluvirin 0.5mls by intramuscular injection. By the following day (19/Oct/2006) she had developed a hugh wheal, about 3 inches in diameter, at the injection site, which was also hot, red and itchy. Further information is requested. A follow-up report was received from a healthcare professional concerning a pregnant 34-year-old female vaccinee. The vaccinee has a history of Hypothyroid since 2003 which is on going. The vaccinee's concomitant medications include Levoxyl, 0.05 mg once a day, orally for Hypothyroid, since 2003 and is on going, Pre-natal vitamins with Doxalymine, 1 tablet once a day, orally for pregnancy since Jun/2006 and is on going, Unisom, 1 tablet once a day, orally for nausea from Sep/2006 to Oct/2006 and Nitrofurantoin, as required, orally for bladder infections in 2004. The vaccinee also received an influenza vaccinee (brand unspecified) in Oct/2005. On 18/Oct/2006, the vaccinee received 0.5ml of Fluvirin, once, intramuscularly into her upper left arm. On 19/Oct/2006, the vaccinee experienced a red wheal at the injection site, which resolved on 23/Oct/2006. On 27/Oct/2006, the vaccine had an elective termination of pregnancy, due to Spina Bifida. The infant was a 12 oz male. The reporter dose not considered the red wheal at the injection site to be serious and is unknown if it is related to Fluvirin. No further information is expected.										10/18/2006	10/27/2006	9		UNK	UNK	UNISOM, NITROFURANTOIN, LEVOXYL, PRE-NATAL VITAMINS WITH DOXALYMINE		The vaccinee has a history of hypothyroid.		CVOX200600266	1						1	Abortion induced; Drug exposure during pregnancy; Injection site erythema; Injection site pruritus; Injection site urticaria; Injection site warmth; Spina bifida	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70279~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0276085	04/12/2007	MD				U	04/09/2007	A child (demographics not provided) with a reported expected date of birth as 25 May 2003, had received transplacental vaccination with 0.5 milliliter of Fluzone, lot number U0931AA, on 16 December 2002 when his mother was vaccinated with the Fluzone vaccine. The expiration date of the Fluzone vaccine was reported as 30 June 2003. Reportedly, the patient has developmental disabilities. The date of diagnosis, and description of the developmental disabilities was not reported. It is important to note that the mother has a history of hypothyroidism that is treated with Synthroid, and she has scoliosis. No other medical information was provided.								Y	N	12/16/2002				UNK	UNK			The patient's mother has a history of hypothyroidism that is treated with Synthroid, and scoliosis. The mother has had one previous pregnancy that was vacuum assisted. The expected date of delivery of the patient was reported as 25 May 2003.		200701043	1						1	Developmental delay; Drug exposure during pregnancy	FLU3~SANOFI PASTEUR~U0931AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0276280	04/13/2007	WI	1.53	1	.5	M	04/13/2007	Patient had a major personality change a day or two after 18 month shots and flu shot. He acted as though intoxicated, had no balence, started chasing and biting parents. He started staring off into space and could not be redirected back to his surroundings. He was later diagnosed with Autism. All of this happened immediatel after these vaccinations.  04/24/2007 MR received from PCP.  12 month well child check on 4/16/2004 with  normal exam and normal growth and development.  See VAERS case # 276278. 18 month check on 10/26/2004 with noted developmental delays.  OV 11/5/04 for fever, congestion and restlessness. PE showed mild oropharyngeal edema and small benign cervical nodes.Assessment:  Pharygitis.  Possible MMR reaction. OV 4/18/2005 for developmental concerns and allergies. Impression: Delayed language skills and socialization.  Possible autism. DX with Autism -moderate degree 8/23/2005 per child development clinic.  04/19/2007 Child Development evaluation for concerns of dev. delays and stereotypical behaviors. DX: Autism/Autistic disorder.  Child meets 8/12 diagnostic criteria.  F/U Neuropsych visit confirms DX of Autism. 1/4/2010 Serious regression after vaccinations. New diagnosed with Autism.								Y	N	10/26/2004	10/27/2004	1	Labs and Diagnostics:  Ambulatory EEG normal.  Brain MRI shows mild non-specific changes. Genetics and organic acid tests 6/2006 essentially normal.	UNK	UNK			PMH: Small mid-muscular VSD.  Developmental speech and language disorder. Ataxia. Developmental delays. ? Absence seizures.  Allergies:  Amoxicillin, oranges, eggs, peanuts.	See report E-15420~ ()~~1.00~Patient		1						1	Abnormal behaviour; Autism; Balance disorder; Immediate post-injection reaction; Oropharyngeal swelling; Personality change; Pyrexia; Regressive behaviour; Respiratory tract congestion; Restlessness; Staring	DTAP~UNKNOWN MANUFACTURER~01698AA~UNK~ID~LL~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~0296N~1~IM~LA~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|PNC~PFIZER\WYETH~AS7560E~4~ID~LL~PNEUMO (PREVNAR)~1	USA	Disabling	Influenza
0276311	04/16/2007	PR	45.0	45		M		Body rash and dermatitis with pain and fatigue extreme, depretion, pruritis									N	04/03/2007			unknown	MIL	MIL		none				1						1	Depression; Dermatitis; Fatigue; Pain; Pruritus; Rash generalised	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0276342	04/16/2007	NE	1.1	1	.1	F	02/07/2007	Patient had 102 temp on 2-4-07. Tylenol given temp decreased. 2-5-07 mother report multiple red spots. 2-7-07 mom brought child into health dept. Noted multiple red spots in hair, face, arms, trunk, legs.									Y	01/26/2007	02/04/2007	9	None	PUB	PUB		None	None			1						1	Body temperature increased; Rash	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B063AA~UNK~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2176KA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0510F~UNK~IM~RL~HEP A (VAQTA)~1|HIBV~MERCK & CO. INC.~0280F~UNK~IM~RL~HIB (PEDVAXHIB)~1|MMRV~MERCK & CO. INC.~1120F~UNK~SC~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08675H~UNK~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0276344	04/16/2007	LA	0.92	0	1	F	03/29/2007	March 16, 2007-Mom called and stated child had been running fever since Wednesday 03-14-07 as high as 103.9. Instructed to contact MD and I would follow up with her on Monday March 19, 2007. March 19, 2007-Phoned mother back and she spoke with MD and he said it was o.k. to give future immunizations. Mother went on to report that child was still running fever since 03-14-07 ranging from 100.5-103.9. She was giving the child Tylenol & Ibuprofen. The child also has a loss of appetite. She also reported that she noted a red bump on the child's right buttock near anus the day she received immunizations but the child wasn't running fever then and today the bump was now formed into a boil and the child is unable to sit down. She was waiting for the MD's office to call her back with an appointment for the child. March 21, 2007-Spoke with mother and child is not on antibiotics by mouth and topical for boil on right buttock and MD said it is not related to immunizations.									Y	03/14/2007	03/14/2007	0		PUB	PUB	None		None			1						1	Anorexia; Furuncle; Pyrexia; Skin lesion	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B018AA~3~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2174KA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y10502~3~SC~RL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~B08649H~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0276426	04/16/2007	AZ	59.0	59		F	04/16/2007	Patient with onset of significant pain in arm in the day following her immunization, mainly at night, worse with movement.  Discussed 2/15/07, pain still exteme, but slowly improving.  Seen 4/12/2007 and diagnosed with tendonitis.  Patient currently undergoing physical therapy.									N	01/08/2007	01/09/2007	1		PVT	PVT	Thyroxine, folic acid, B12,B6,omega acid, calcium, garlic, MVI	no	hypothyroid, elevated cholesteral			1						1	Pain in extremity; Physiotherapy; Tendonitis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F602311~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0276521	04/16/2007	OK	60.0	60		M	04/13/2007	Information has been received from a 61 year old male with allergy to NEOSPAN who in approximately December 2006 (reported as 2 or 3 months ago), was vaccinated with a dose of Zostavax. Concomitant vaccination included influenza (unspecified). On approximately 24-MAR-2007 the patientcame down with shingles. The patient experienced pain in legs, calfs, and above left kidney. Outcome was reported as recovering. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.				Y					N	12/01/2006	03/24/2007	113	None	OTH	OTH		Drug hypersensitivity			WAES0703USA00102	1						1	Herpes zoster; Pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~UN~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0276935	04/16/2007					U	04/13/2007	Information has been received from a registered nurse, concerning patients who were vaccinated simultaneously with a dose of Gardasil and a dose of hepatitis A vaccine (manufacturer unspecified) (dates not specified). Other possible concomitant therapy included influenza virus vaccine (unspecified). The nurse reported that she heard through a clinical coordinator who heard from another nurse, that the patients experienced unknown  reactions when Gardasil was given at the same time as an unknown hepatitis A vaccine. The reporting nurse added that when people get the flu vaccine they are sometimes not able to lift their arm afterwards. At the time of the report, it was unknown if the patients recovered from the events. Additional information has been requested.									U				Unknown	OTH	OTH	Unknown		Unknown		WAES0704USA00003	1						1	Mobility decreased	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~MERCK & CO. INC.~~UNK~UN~~HEP A (VAQTA)~1|HPV4~MERCK & CO. INC.~~UNK~UN~~HPV (GARDASIL)~1	USA		Influenza
0268167	04/17/2007	MN	8.0	8		M	04/05/2007	Large local swelling over entire upper arm-entire deltoid triceps muscle.									Y	11/20/2006	11/22/2006	2	referral to allergist	PVT	PVT		None	Mild Intermittent Asthma			1						2	Injection site swelling	FLU3~SANOFI PASTEUR~U2202AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0276434	04/17/2007	WA	50.0	50		F	04/16/2007	8 hours post injections unable to move arms, joints aching. In bed next 2 days, felt like tin woods man, fever 101 with nausea following day. Took ibuprophen, alka selzer. Called Health dept. to report reaction. Right arm continued aching, unable to pull up blankets at night etc. Right wrist began aching, loss of strength, then left wrist, then jaw, ankles, knees. Am now being treated for arthritis, on Relefen. Aching joints, loss of hand strength continues 5 months later.  05/17/2007 Several office notes received from PCP.  OV 12/30/06 for c/o longstanding wrist pain 2' to wrist fx in 1990's and cough with increasing chest tightness and thickened sputum. Assessment:  Chronic bronchitis with thisckened sputum.  Right wrist pain.  OV 2/26/07 for c/o pain in multiple joints. Assessment:  Likely osteoarthritis.  Wrist pain exacerbated by previous fx.   OV 4/19/07 F/U Osteoarthritis improved.  Insomnia improved.  Assessment:  Osteoarthritis, insomnia, allergic rhinitis all improved.  06/11/2007 MR received for single visit for tendinitis of the R wrist.  Hx of fx of Rwrist 20 years ago and 2 recent minor incidents. ROM is limited. Tenderness noted with palpation around the radius and ulnar side of the wrist. DX: Tendinitis of the R wrist.								Y	N	11/17/2006	11/17/2006	0	tests show inflammation                         (note for question 13-tdap and influenza manufacturer--Sanofi Pasteur, Pneumo 23 manufacturer--Merck). Labs and Diagnostics:  2/28/07 Uric Acid-normal, ESR- 66, ANA-normal, RA-negative.	UNK	UNK	flonase	none	cat,horse,plantain,rye fungus allergies. PMH: Right wrist fracture 1990s.	sore arm 3 days~Tetanus Toxoid (no brand name)~~35.00~In Patient		1						1	Arthralgia; Arthritis; Asthenia; Hypokinesia; Inflammation; Joint range of motion decreased; Laboratory test abnormal; Nausea; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U2240AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0391F~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2638AA~4~IM~LA~TDAP (ADACEL)~1	USA	Disabling	Influenza
0276538	04/17/2007	NH	36.0	36		F	04/16/2007	Pt developed autoimmune hemolytic anemia and states she started to feel her symptoms shortly after flu vaccine (24-48 hrs after).  04/24/2007 MR received from OBGYN which includes several hospital records as well. Pt initially presented to the hospital on 11/23/2007 with a drop in the patient's Hct and Hgb noted on 11/22/2007. This hemolytic anemia followed on the heels of passing tea colored urine, nausea, vomiting, icterus  and elevated LFTs which pt. was being f/u for. Txd with steroids and discharged on PO prednisone. Final DX:  IUP at 21 weeks with hemolytic anemia of uncertain etiology. F/U with Heme/Onc MD 11/29/06. Doing well on steroid tx.  Hct increasing. DX: Autoimmune Hemolytic Anemia.					Y	3			Y	10/16/2006	10/18/2006	2	Hematology and GI consult confirming autoimmune hemolytic anemia.  Labs and Diagnostics: UA (-) for Bili. CBC with Hgb. of 8.0 and Hct. of 21.4. WBCs 12.6.  Total Bili 3.1. Direct Bili 0.7. SGOT 8, AST 48. ALT mildly elevated. ANA (-). RF (-). EBV (-), Hep B&C (-), HIV (-). Parvovirus (-).  HCT 35.8 on 3/1/07.  Hct  42.0 on 4/5/07.	PVT	PVT	ZOLOFT 75 mg/ day, Prenatal	None	Pt was 16 weeks pregnant when given vaccine.  PMH: Current pregnancy at 21+ weeks gestation on 11/23/06. Ovarian CA, SBO, benign breast cyst, Gallbladder disease with cholecystectomy. Occ. H/A.  Anxiety/depression. Uterine fibroid. Elevated bilirubin in past of unknown etiology. Allergies: Percocet intolerance.			1						1	Anaemia haemolytic autoimmune; Drug exposure during pregnancy; Haematology test	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70868~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0276546	04/17/2007	LA	4.0	4		F	04/12/2007	DTaP given (L) IM and Proquad given (L) sub 4/9/07. Pt came in 4/11/07 w/local reaction, red hot and hard, no itching, no fever. Dr said do warm compresses mother did. Pt came back 4/12/07 and reaction was bigger, harder, same redness w/blisters and itches now. Dr pres. Atarax and Prednisolone				Y					N	04/09/2007	04/11/2007	2	none	PVT	PUB	Clinda 300 mg po TID floxin	none	AR, RAD, Chronic OM			1						1	Injection site erythema; Injection site induration; Injection site pruritus; Injection site reaction; Injection site vesicles; Injection site warmth	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B044BA~5~~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2283AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z05472~4~~RA~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~1262F~1~~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0276566	04/17/2007	NJ	0.9	0	.9	F		Pt had a high fever early in the afternoon. After her nap the fever dropped to about 100. After about an hour of normal activity, she slumped over in her chair and started convulsing. and stopped breathing. After mouth to mouth was given she began breathing on her own. The paramedic took her to the hospital.  05/01/2007 MR received for ER visit of 11/25/2006 for c/o fever and seizure activity x1.  Infant became stiff, turned blue and was not breathing x 30 sec. per parents. PE: (+) for rhinorrhea, pharyngeal erythema, and tonsillar exudate.  Temp in ER was 104'F rectally.  Otherwise WNL. DX: Febrile Seizure. Viral Syndrome. 05/17/2007 Vax record received.  Vax for 11/21/2006  Prevnar- Wyeth-BO8691F Hib-Aventis-UE054AA Flu-unknown. Info updated in VAERS database and submitted for scanning.				Y					Y	11/21/2006	11/25/2006	4	Negative. Labs and Diagnostics: UA (+) for trace protein and Large blood. CRP high at 22.0. CBC unremarkable. Chemistry remarkable for AST of 79. Blood Culture (-).  UC (-). RSV and Flu (-).  CXR normal.	PVT	PVT			PMH: none. NKDA.			1						1	Convulsion; Pyrexia; Respiratory arrest	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~SANOFI PASTEUR~UE948AA~3~~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~BO5691F~3~~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0276744	04/18/2007	CA	27.0	26		F	04/16/2007	This case was reported by a consumer and described the occurrence of injection site redness in a 27-year-old female subject who was vaccinated with Fluarix for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medications included oral contraceptive (Birth control pill). On 11 October 2006 at 15:00 the subject received unspecified dose of Fluarix in the left arm. Three hours after vaccination with Fluarix, the subject experienced injection site redness (baseball size), injection site pain, heat at injection site and radiating pain in arm. At the time of reporting the events were resolved.									Y	10/11/2006	10/11/2006	0	UNK	PVT	PVT	Oral contraceptive	Unknown	The subject is allergic to avacado and canalope.		A0647497A	1						1	Injection site erythema; Injection site pain; Injection site warmth; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA201AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0269521	04/19/2007	CA	23.0	23		F	04/19/2007	This case was reported by a healthcare professional to a sales representative and described the occurrence of injection site reaction in a 23 year old female subject who was vaccinated with Flurarix for prophylaxis. On 29 September 2006, the subject received a dose of Fluarix intramuscularly in the left arm. Within 30 minutes of vaccination, the subject experienced injection site swelling the size of a baseball and the subject's arm was red from shoulder to elbow. At the time of initial reporting, 03 October 2006, the event was worse. The healthcare professional considered the event was probably related to vaccination with Fluarix. Follow-up information received on 16 April 2007 via a nurse indicated that the events resolved by 13 October 2006. In the reporter's opinion, the events were related to treatment with Fluarix and were possibly serious as intervention was indicated.									Y	09/29/2006	09/29/2006	0	UNK	PVT	PVT		Unknown	The subject's medical history, concurrent conditions, and concurrent medications were not reported. The nurse reported that two other subjects experienced adverse events following receipt of Fluarix. Please see case A0622337A and A0622338A.		A0622331A	1						2	Injection site erythema; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA201AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA		Influenza
0276972	04/19/2007	FL	21.0	21		M	04/16/2007	Erythema, Edema, and decreased ROM left arm with Palp left Axillary Lymph Nodes				Y					Y	04/05/2007	04/13/2007	8		MIL	MIL						1						1	Erythema; Joint range of motion decreased; Lymphadenopathy; Oedema; Palpitations	BCG~SANOFI PASTEUR~~UNK~ID~LA~BCG (MYCOBAX)~1|FLU3~SANOFI PASTEUR~U2259AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020076~UNK~ID~~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~Z06444~UNK~IM~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0276996	04/19/2007	GA	28.0	28		F	04/19/2007	LIGHT HEADED, ITCHY ALL OVER, DIZZIE WHEN TRYING TO WALK, STOMACH ACHE, HEAD ACHE, NAUSEATED,AND SWEATY LASTED TWO DAYS, WAS TAKEN TO THE EMERGENCY ROOM BOTH TIMES				Y				Y	N	11/19/2002	11/19/2002	0		MIL	MIL		none at times of shots	none			1						1	Abdominal pain upper; Dizziness; Headache; Hyperhidrosis; Nausea; Pruritus	ANTH~MICHIGAN DEPT PUB HLTH~fav063~1~~LA~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~4020040~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0277006	04/19/2007	NJ		63		F	03/27/2007	1 Day after immunizations, patient took BS in AM - routine BS - 294 fasting prior to admin. of test 7 AM 10/11/06.									Y	10/10/2006	10/11/2006	1	BS 294	PUB	PUB		None	Diabetes, increase BP		NJ200704	1						1	Blood glucose abnormal; Blood glucose increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~07278~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1048P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~1048P~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0277120	04/20/2007	NY	1.4	1	.4	M	04/19/2007	Patient had onset of generalized tonic clonic seizures evening 2 days after immunizations. Patient had 3 days of URI's x 1 and fever prior to immunizations. Patient hospitalized for continued seizures. Patient received Dilantin and Heparin.  5/22/07 Received hospital clinic medical records which reveal patient experienced congestion, rhinorrhea, cough, vomiting, fever for 3 days prior to vax on 2/23/07.  Dx w/viral URI & treated symptomatically.  Vax record confirms that reported on VAERS form.  7/31/07 Received medical records from hospital which reveal patient experienced cough, runny nose & cold s/s.  Had seizures x 3 on 2/25/07.  Temp 99.4.  Tx w/dilantin. FINAL DX: convulsive epilepsy; acute URI; acute sinusitis; developmental delay.				Y	Y				N	02/23/2007	02/25/2007	2	RSV (+), Brain CT normal, Brain MRI normal	PVT	OTH	Tylenol	URI with fever (T = 102.3)	None			1						1	Computerised tomogram normal; Grand mal convulsion; Nuclear magnetic resonance imaging brain normal; Respiratory syncytial virus infection; Virus serology test	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B035AA~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~42307AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B086818~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0277121	04/23/2007	CA	52.0	52		F	04/15/2007	Flu shot on 11/6/03. 11/9/03 heart rate increased, loss of consciousness, viral S/S continued, heart rate and S/S vagus nerve paresis continue to date. No prior heart/vagal DX prior to injection.  5/8/07 Received medical records from hospital which reveal patient experienced rapid heart rate & hot sensation on 11/9/03 & was seen in ER.  Radiated up her chest & into her face & she passed out for a few seconds.  Felt tired & scared when awoke.  PAT episodes had been increasing since 2001 but had never had syncope before.  Had taken decongestant for sinus congestion which had seemed to aggravate symptoms in past. Treated w/Inderal & ativan w/good results. FINAL DX 11/9/03: Paroxysmal atrial tachycardia w/syncope. Next ER records are of 1/17/04 which reveal patient had right hip pain & muscle spasm.  Treated w/pain med, muscle relaxers & d/c to home. FINAL DX: right hip pain, unknown etiology. 1/30-2/3/04 Patient was referred for Physical Therapy for back/buttock pain/muscle spasm w/good results. 4/2/07 Admitted to hospital for chest pain, palpitations, chest pressure which extended into left arm.  Cardiac consult obtained.    Was already scheduled for later same month for electrophysiology studies & possible ablation of arrhythmia. FINAL DX: Chest pain, possibly angina. 4/10/07Had Electrophysiologic study & radiofrequency ablation for recurrent PSVT unresponsive to meds in setting of no structural heart disease.  Test revealed dual AV node physiology w/nultiple AV nodal slow pathways; multiple AV nodal reentry SVTs; & no inducible SVT s/p ablation.  Was hospitalized overnight, did well & was d/c to home next day.  Additional outpatient Labs & x-ray reports were submitted.  Continues to have Vagal nerve paresia cardiac irreg esophageal manometry result LES - 38.5 Are other victims being tracked with these same s/s ?								Y	N	11/06/2003	11/09/2003	3	Available on request from hospital ER. x3 visits. 11/9/03 LABS: EKG showed NSR w/minor nonspecific T wave changes.  Troponin 0.05. CK/MB was 1.   1/17/04 LABS: X-rays of chest & hip were WNL.  EKG was WNL.  Labs were all WNL except ro decreased T4 w/normal TSH. 4/2/07 LABS: Recent stress test as outpatient was reported as WNL.  30-day event monitor revealed SVT.  CPK 59, MB less than 1.  CBC & chem panel were WNL.  EKG showed sinus bracycardia.	PUB	OTH	Estrace 1 mg T QD	NONE	NKA 11/9/03 PMH: PAT since 2001. 1/17/04 PMH: multiple medical problems: tachycardia, atrial fibrillation, possible early hypothyroidism.			1						1	Heart rate increased; Loss of consciousness; Paresis; Supraventricular tachycardia; Viral infection	FLU3~SANOFI PASTEUR~U1089AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0277171	04/23/2007		8.0	8		U		A report was received from a health care professional on 26/Oct/2006 concerning an 8-year-old vaccinee (sex unspecified). No details of the vaccinees past medical history or concomitant medications have been provided. On an unspecified date the vaccinee was inadvertently administered Fluvirin 0.5mls, which had been previously frozen. No adverse reactions have been reported. Further information is requested. A follow-up report was received from a health care professional on 11/Apr/2007 concerning an 8-year-old vaccinee, sex not reported. No details were provided regarding the vaccinee's medical history or concomitant medications. On 21/Oct/2006, the vaccinee inadvertently received Fluvirin, which had been previously frozen, intramuscularly into their left deltoid. On 21/Feb/2007, the vaccinee developed Flu. The symptoms have resolved. The reporter considers the symptoms to be related to pneumonia. No further information is expected.										10/21/2006	02/21/2007	123		UNK	UNK	Concomitant drugs not reported.				CVOX200600325	1						1	Influenza; Medication error; Vaccination failure	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71209~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0277173	04/23/2007	GA	5.0	4		F	03/23/2007	Mom reported began vomiting at 3AM on 12/30/06. Temp 101 (orally) saw MD two days later and was admitted to the hospital with flu and bronchitis. See attached.  4/24/07 Received D/C summary w/VAERS report which reveals patient experienced severe diffuse cough, earache, flu-like symptoms, nausea & vomiting for 3 days prior to admit on 1/8/07-1/11/07.  Had been treated as outpatient for several days w/antibiotics & neb tx w/o improvement.  Temp on admit was 100.8, resp 32.  Exam revealed wheezing & rhonchi.  Treated w/IV antibiotics & nebs.  Continued to have significant bronchospasms until Atrovent added to nebs & fevers of 102-103 until placed in mist tent.  Treated for bacterial appearing conjunctivitis.   Wheezing resolved by d/c but had continued cough.  Continued on nebs, cough meds & antibiotics upon d/c. FINAL DX: influenza Type B, community-acquired pneumonia associated w/influenza, allergic bronchial asthma and respiratory distress.					Y	7			Y	12/29/2006	12/30/2006	1	LABS: nasopharyngeal swab & viral c/s revealed influenza Type B.  CXR was neg.  Sed rate elevated at 28.  CBC differential showed left shift.  RSV was neg.  Blood c/s neg.	PUB	PUB		None	Asthma	~DTaP (no brand name)~4~1.00~In Sibling|~Pneumo (Prevnar)~3~1.00~In Sibling	GA07013	1						1	Body temperature increased; Bronchitis; Influenza; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71032~1~IM~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0277174	04/23/2007	GA	1.46	1	.5	F	03/07/2007	Mom reported began vomiting around 8 or 9 pm on 12/29/06. Temp 102.4 (R) Irritable. Saw doctor two days later and was admitted to hospital with flu and bronchitis. See attached.  4/24/07 D/C summary came w/VAERS report which reveals patient experienced severe diffuse cough, earache, nausea & vomiting for 3 days prior to admit on 1/8/07-1/11/07.  Had been treated as outpatient for several days w & neb tx w/o improvement.  Temp on admit was 100.8, resp 32.  Exam revealed wheezing & rhonchi.  Treated w/IV antibiotics & nebs.  Treated for bacterial appearing conjunctivitis.   Wheezing resolved by d/c but had continued cough.  Continued on nebs, cough meds & antibiotics upon d/c. FINAL DX: community-acquired pneumonia, allergic bronchoasthma, respiratory distress, conjunctivitis, and acute influenza Type B.					Y	7			Y	12/29/2006	12/29/2006	0	LABS: Viral wash revealed influenza Type B.  CXR was neg.  Sed rate elevated at 28.  CBC differential showed left shift.  RSV was neg.  Blood c/s neg.	PUB	PUB		None	Asthma	~Influenza (Seasonal) (no brand name)~1~4.00~In Sibling	GA07012	1						1	Body temperature increased; Bronchitis; Influenza; Irritability; Vomiting	DTAP~SANOFI PASTEUR~U1857CA~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2191CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB130AA~1~IM~LL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~B08657C~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0277176	04/23/2007	PA	1.01	1	.0	F	04/17/2007	Atypical febrile seizure 05/01/07-records received from facility for DOS 02/15/07 DX complex febrile seizure and fever viral illness.Tonic clonic seizure lasting greater than 30 minutes.PMH negative. In ED not responding to stimuli, noisy breathing. Temp 38.4. Admitted for observation.				Y	Y	2			Y	02/08/2007	02/16/2007	8	Negative workup for other causes of seizure records received 5/1/07- Labs. cytomegalovirus DNA negative. Epstein Barr negative.Varicella zoster virus negative.Blood culture no growth. Urine culture no growth.Enterovirus PCR negative. CSF culture negative. HSVP3 HSV PCR negative.CXR: probable right basilar atelectasis. EEG normal tracing for age and state.	PVT	PVT	None	None	None			1						1	Febrile convulsion	FLU3~SANOFI PASTEUR~U2312AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1008F~1~IM~RA~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~1351F~1~SC~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Hospitalisation	Influenza
0277180	04/23/2007	MN	1.5	1	.5	M	04/12/2007	Redness and swelling of right upper thigh with lg. firm lump temp 102-102 deg x 24 hrs									Y	11/08/2006	11/09/2006	1		PUB	PUB						1						1	Body temperature increased; Injection site erythema; Injection site induration; Injection site swelling	DTAP~SANOFI PASTEUR~C2627AA~4~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2174LA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0277190	04/23/2007	GA	71.0	71		M	11/02/2006	Client received flu vaccine that was later determined mishandled. (Potentially frozen during shipment).									Y	10/23/2006				PUB	PUB		None	HTN, COPD			1						1	Medication error	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71210~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0277191	04/23/2007	GA	5.0	5		F	11/02/2006	Client received potentially mishandled flu vaccine DOB 7/20/2001.									Y	10/20/2006			None	PUB	PUB						1						1	Medication error	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71210~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0277192	04/23/2007	GA	51.0	51		M	11/02/2006	Client received flu vaccine that was potentially mishandled during shipment.									Y	10/23/2006				PUB	PUB		None	None			1						1	Medication error	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71210~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0277194	04/23/2007	GA	25.0	25		F	11/17/2006	Pain, redness, swelling in arm; can't lift arm. Went to doctor; received antibiotics to ward off abscess formation.				Y					Y	11/13/2006	11/14/2006	1		OTH	PVT						1						1	Erythema; Hypokinesia; Oedema peripheral; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601311~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0605R~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0277203	04/23/2007	HI	6.0			M	04/13/2007	Fever for 3 days from day of immunization then rash developed (maculopapular, red, blanching).										04/09/2006	04/12/2006	3	None	PVT	PVT	None	URI s/s	30 week premie, received syngist - last dose 2/07.			1						1	Inappropriate schedule of drug administration; Pallor; Pyrexia; Rash erythematous; Rash maculo-papular	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B096CA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2165FA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08670H~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0023U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0277229	04/23/2007	MI	15.0	15		M	04/23/2007	3/21/07 Patinet from a foreign country.  Child seen for initial refugee physical.  Noted rt. knee pain on and off since 2006, diastolic heart murmur.X-ray rt. knee and cardio referral ordered.  3/23/07 translator called for mother stating child couln't walk due to pain in legs; sent to ER.  X-rays and labs done, diagnosed with acute exacerbation of Rheumatic Fever.  Dishcarged on Pen VF TID x10days, ASA 650 mg.q 6hrs x 5weeks, Bicillin IM q 4weeks.  Follow up with cardiologist. 4/20/07  Symptoms are now resolved. 05/01/07-records received from reporter. visit notes on 3/21/07 document c/o right knee pain which has occurred off and on since 2006. HX of TB exposurePE revealed heart murmer. HX of rheumatic fever.				Y					Y	03/21/2007	03/23/2007	2	records received 5/1/07- cxr and sputum negative.	UNK	UNK			records received 5/1/07-rheumatic fever			1						1	Abasia; Arthralgia; Cardiac murmur; Condition aggravated; Pain in extremity; Rheumatic fever; X-ray	FLU3~SANOFI PASTEUR~U2243AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0001~1~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1003F~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|MNQ~SANOFI PASTEUR~U1908AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B013AA~1~IM~LA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1502F~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0267494	04/24/2007	PA		27		M	11/13/2006	27 yo M w/PMH for purpura as a child, IBS, and s/p tonsillectomy, was admitted on 11/9/06 with hypoxia, worsening pulmonary infiltrates, and hemoptysis. Pt rec'd flumist inh on 10/5. On 10/6 the pt was admitted to an OSH w/RLL PNA and was tx'd with IV azithromycin, improved significantly, d/c'd home and returned back to work. 2 wks prior to 10/25 pt developed rash on back trunk and groin. On 10/25 pt was admitted to the OSH w/3rd degree AV block an txf'd to HUP on 11/5 where he was dx'd w/idiopathic myocarditis and d/c'd home w/a cardiac monitor. On 11/9 pt was admitted to HUP w/pulmonary inflitrates and systemic vasculitis. There is a hypothesis that rxn may be due to flu vaccine but has not been confirmed. Pt remains in hospital for further eval.					Y	0				10/05/2006	10/06/2006	1		UNK	UNK	Famotidine					1						4	Atrioventricular block complete; Haemoptysis; Hypoxia; Lung infiltration; Myocarditis; Rash; Vaccination complication; Vasculitis; Asthenia; Atrioventricular block; Blood test; Body temperature increased; Catheterisation cardiac; Chest X-ray; Chest pain; Computerised tomogram; Cough; Dyspnoea; Echocardiogram; Electrocardiogram; Fatigue; Headache; Nuclear magnetic resonance imaging; Pain; Pyrexia; Vomiting; X-ray	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~4|FLUN3~MEDIMMUNE VACCINES, INC.~500430P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~5	USA	Hospitalisation	Influenza
0277321	04/24/2007	CA	21.0	21		F		A report was received from a healthcare professional on 16/Jan/2007 concerning a 20 year old female vaccinee. No details were provided regarding the vaccinee's medical history or concomitant medications. On 15/Jan/2007 the vaccinee received a dose of Fluvirin intramuscularly. The same day, the vaccinee experienced swelling at the injection site with redness and myalgia in the upper arm in the area where the dose was administered. Further information will be requested. A Follow-up report was received from a healthcare professional on 13/Apr/2007. The vaccinee has been confirmed as a 21-year-old female. No details were provided regarding the vaccinee's medical history or concomitant medications. On 10/Jan/2007, the vaccinee was administered Fluvirin, intramuscularly in her deltoid. On 11/Jan/2007 the vaccinee experienced severe pain in her left upper arm and decreased range of movement at her left shoulder. The vaccinee also experienced swelling in her upper arm. The vaccinee was treated with Tylenol, Benadryl, Medrol Dosepack with ice, rest and elevation. The symptoms resolved on 17/Jan/2007. The reporter considers the event to be serious due to disability. No further information is expected.								Y		01/10/2007	01/11/2007	1		UNK	UNK	Concomitant drugs not reported.		None		CVOX200700010	1						1	Injection site erythema; Injection site pain; Injection site swelling; Joint range of motion decreased; Myalgia; Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72002~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0275900	04/25/2007	MD	1.32	1	.3	M	04/23/2007	SERIOUSNESS CRITERIA: OTEHR - MEDICALLY SIGNIFICANT.  Initial ifnormation received from another manufacturer (reference number WAES 0208USA01250) on 10 April 2007. the information was provided to the other manufacturer from a health care professional. The following case information is verbatim from the other manufacturer's report: Information has been received from a case in litigation concerning a 24-month-old male, who was injected with vaccines containing Thimerosal. It is alleged that between 12 and 25 micrograms of toxic ethylmercury were injected into the patient's body with each individual dose of Thimerosal and that the schedule of injections introduced a cumulative dose of 238 micrograms. It is further alleged that beginning in approximately 13-NOV-1998, the patient began to display symptoms of neurological damage consistent with mercury poisoning, not limited to losing his language skills engaging in repetitive and stereotypical behaviors, suffering from diminished cognitive ability and becoming socially withdrawn. The patient has since been diagnosed as suffering with mercury poisoning and disintegrative (or late onset, degenerative or regressive) autism including severe, devastating and permanent neurological injuries. Follow up information was received alleging that the patient was exposed to airborne mercury vapors and mercury through the food chain, other mercury-laden products and power plant emissions. It is also alleged that patient was exposed to mercury from continually inhaling and ingesting industrial mercury emissions from fossil fuel driven power plants. The mercury included in the thimerosal-laden products and power plant emissions together caused him to suffer serious and permanent injuries, including mental, intellectual, developmental and neurological incapacity and associated learning disabilities, disorders and impairments. It is further alleged that the patient had heightened vulnerability to suffer neurological injuries from industrial mercury as a direct result of thimerosal exposure. Additional follow up information indicated that the patient's family history is positive for allergic rhinitis and asthma. On 14-NOV-1996, 10-DEC-1996, and 13-AUG-1997 (Lot # 622792/0312E), the patient was vaccinated with the first, second, and third doses of hepatitis B virus vaccine. Other therapy included: globulin, immune (RHOGAM); Dtp on 02-FEB-1997 (lot 433-566), 19-MAR-1997 (444-251), 14-MAY-1997 (lot 444-249), 25-MAY-1998 (lot 453-844), and 14-SEP-2001 (lot 513A2); ACTHIB on 05-FEB-1997 (lot 433-566), 15-MAR-1997 (lot M035PE), 14-MAY-1997 (lot M30CPN), and 10-MAR-1998 (lot M285RJ); IPOL on 05-FEB-1997, 19-NOV-1997, 4-MAY-1997, and 14-SEP-2001, MMR II (lot 497814) on 19-NOV-1997, VARIVAX (lot 623130/0568E); and FLUSHIELD on 19-NOV-1997 (lot 497814) and 13-NOV-1998 );pt 20308). The first diagnosis of autism was noted to be July 1999. The patient was also noted to have neurodevelopmental disorder. The autism and neurodevelopement disorder was noted to be caused by thimerosal. Information received from medical records on 29-MAR-2007 contained the following adverse events: severe peanut allergy (2001); tree nut allergy; allergic rhinitis; mild persistent asthma; ear drainage (16-JUNE-2000); recurrent ongoing otitis media (approximately January 1999); shellfish, strawberry, and grape jelly allergy. Upon internal review, autism, neurological injuries, serious and permanent injuries and mercury poisoning considered to be other medical events. Additional ifnormation has been requested.JAll medical records are available upon request.				Y					N	03/10/1998	11/13/1998	248	Unknown	OTH	OTH			The patient's past medical history is unknown. Family history is significant for allergic rhinitis and asthma.		200701134	1						3	Asthma; Autism; Cognitive disorder; Disturbance in social behaviour; Ear disorder; Food allergy; Learning disability; Metal poisoning; Nervous system disorder; Neurodevelopmental disorder; Otitis media; Psychomotor skills impaired; Rhinitis allergic; Social avoidant behaviour; Speech disorder; Speech disorder developmental; Stereotypy; Autism; Developmental delay; Metal poisoning; Neurodevelopmental disorder; Reaction to preservatives; Speech disorder; Abnormal behaviour; Asthma; Autism; Cognitive disorder; Developmental delay; Food allergy; Learning disability; Mental disorder; Mental impairment; Metal poisoning; Nervous system disorder; Neurodevelopmental disorder; Otitis media; Rhinitis allergic; Social avoidant behaviour; Speech disorder; Stereotypy	HEP~MERCK & CO. INC.~0321E~3~~UN~HEP B (RECOMBIVAX HB)~1|HIBV~PFIZER\WYETH~M285RJ~4~~UN~HIB (HIBTITER)~2|DTAP~UNKNOWN MANUFACTURER~453844~4~~~DTAP (NO BRAND NAME)~3|FLUX~UNKNOWN MANUFACTURER~497814~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|HEP~MERCK & CO. INC.~0312E~3~~~HEP B (RECOMBIVAX HB)~3|HIBV~SANOFI PASTEUR~M285RJ~UNK~~~HIB (ACTHIB)~3|IPV~SANOFI PASTEUR~~3~~~POLIO VIRUS, INACT. (IPOL)~3|MMR~MERCK & CO. INC.~497814~1~~~MEASLES + MUMPS + RUBELLA (MMR II)~3	USA	Emergency room visit	Influenza
0267201	04/26/2007	CO	5.0			M	04/26/2007	A 5-year-old male patient received Fluzone influenza virus vaccine on 17Nov2006. The patient was being seen for an asthma recheck, a mild upper respiratory tract infection, and to receive the influenza injection. The medical assistant had spoken with the patient's mother asking about allergies prior to the flu injection and was told that the patient's allergies included grass, leaves, and outdoor allergies. The patient's grandmother was asked prior to the influenza injection being administered if the patient was allergic to eggs and she stated that he was not. It was noted in the IZ database that the patient had previously received influenza injections on 14Nov2002, 11Dec2002, 17Nov2003, and 15Nov2005. The mother and grandmother stated that he had no previous abnormal reaction to the influenza injections. On 17Nov2006, approximately 7 minutes after the Fluzone was administered, the grandmother returned with the patient and he had an allergic reaction where mild hives on the face developed. When the grandmother was further questioned, she recalled that the patient would get hives when given eggs in the past, first occurring as a baby. The patient was given 5 mL of diphenhydramine 12.5 mg/5mL in the office. The patient's hives began to resolve within 10 minutes after the diphenhydramine was give. No anaphylaxis symptoms were noted. Precautions and a follow up appointment were given to the patient. The patient was given diphenhydramine 12.5 mg/5mL and instructed to take 5 mL every 4 to 6 hours as needed.									Y	11/17/2006	11/17/2006	0	none	UNK	UNK	unknown	mild upper respiratory infection	asthma, allergies included grass, leaves, and outdoor allergies, hives with eggs			1						2	Hypersensitivity; Urticaria	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0277408	04/26/2007		17.0			F	04/25/2007	This case was reported by a healthcare professional and described the occurrence of miscarriage in a 17-year old female subject who was vaccinated with Boostrix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not provided. On an unspecified date the subject received n unspecified dose of Boostrix (unknown). The subject participated in an observational study, 100454. On an unspecified date, an unspecified time after vaccination with Boostrix, the subject became pregnant. This was her first pregnancy. The subject was seen in the emergency room for vaginal bleeding and abdominal pain at approximately seven weeks of pregnancy. Per the reporter, this would indicate that she was vaccinated approximately 13 days prior to the last menstrual period prior to her pregnancy. On an unspecified date, an unspecified time after vaccination with Boostrix, the subject had a miscarriage. This case was assessed as medically serious by manufacturer. At the time of reporting the outcome of the events were was unspecified.				Y					U				UNK	OTH	OTH		Unknown	The subject's medical history, concurrent conditions, and concurrent medications were not provided.		A0648430A	1						1	Abdominal pain; Abortion spontaneous; Drug exposure during pregnancy; Vaginal haemorrhage; Abdominal pain; Abortion spontaneous; Ultrasound scan abnormal; Vaginal haemorrhage	TDAP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~UN~TDAP (BOOSTRIX)~1|FLU3~SANOFI PASTEUR~U2166KA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|MNQ~SANOFI PASTEUR~U1920AA~UNK~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B011BA~UNK~IM~LA~TDAP (BOOSTRIX)~2	USA	Emergency room visit	Influenza
0277447	04/26/2007	TX	76.0	76		F	04/26/2007	Developed pain, redness and swelling in left upper arm muscles and shoulder muscles. Became unable to stretch arm outward or upward and could not pick up objects till days later [left arm]. Has had small improvement in the intensity of the pain but I hear her groan several times a day whether moving or not. Using her left arm to IE hold a book, reading, is hurtful at least. She insists on doing dishes but has accepted my helping her. The pain is mild to intense; quite variable but always present. We had hoped using the arm would improve it but there is no apparent relaxing of the above symptoms. Note: we were having coffee out side and for no reason her left hand involuntarily released her cup breaking it???? She is having more difficulty using her walker as the left arm pain tends to increase pushing it. This vaccine injury has caused her additional depression by adding this disability to the multiple sclerosis she has had for 30 + years and is a progressive situation IE when we went to a store, she used the wheeled basket as a walker but now she seldom goes out because it's only by wheelchair now. Due to the decrease in strength of legs and all muscles generally since the flu shot has made it harder for her to get in & out of bed and I set up a portapotty by her bed each night so she does not need to try and make it to the bathroom. The overall situation is grim at best. Today at the doctors she was given a cortisone shot today [04/26/07][12 noon] and she just told me [7PM] it does not feel any better. She states she feels her nervous system has been affected. IE left arm and legs weakness, walking more difficult, balance unreliable, dizziness more frequent, pain and discomfort in left arm unyielding and unforgiving.				Y					N	01/10/2007	01/10/2007	0	none yet. Had a regular once in a while blood draw for testing right after the vaccination.	PVT	UNK	avapro - 150mg 1x day & actnel 35mg 1x week. Vit C,	multiple sclerosis, high blood pressure. osteoperosis	multiple sclerosis & high blood pressure. osteoperosis			1						1	Asthenia; Balance disorder; Depression; Dizziness; Gait disturbance; Joint range of motion decreased; Muscular weakness; Oedema peripheral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601411~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0277503	04/27/2007	MA	43.0	43		F	04/27/2007	C/O PAIN IN AMR,NUMBNESS AND TINGLING, BUT DID NOT PRESENT TO PHYSICIAN WITH THESE SYMPTOMS UNTIL 03/16/07 AT WHICH TIME SYMPTOMS HAD RESOLVED.THIS WHAT THE PT.STATES.									Y	12/05/2006	12/06/2006	1		PUB	PUB	NONE	NONE	NONE			1						1	Hypoaesthesia; Pain in extremity; Paraesthesia	FLU3~SANOFI PASTEUR~U2244AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVBO99BA~1~IM~LA~HEP A (HAVRIX)~1	USA		Influenza
0277511	04/27/2007	MN	1.92	1	.9	F	04/27/2007	Client received age inappropriate 0.5ml dose of Fluzone rather than 0.25ml in her right thigh. No adverse event or reaction has been reported at this time.									U	04/10/2007				PUB	PUB		Parent reported client to have a runny nose.				1						1	Incorrect dose administered	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B035AA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2313AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0804F~1~IM~RL~HEP A (VAQTA)~1|HIBV~MERCK & CO. INC.~0278F~4~IM~LL~HIB (PEDVAXHIB)~1|IPV~SANOFI PASTEUR~Z0001~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~0972F~2~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08672H~1~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0277534	04/27/2007	WA	27.0	25		F	04/27/2007	Pain at injection site. Loss of function of shoulder. Patient claims that injection caused permanent damage to shoulder joint.				Y					U	10/21/2006	10/26/2006	5	Unknown	OTH	OTH		Unknown	Osteoporosis			1						1	Arthropathy; Injection site pain	FLU3~SANOFI PASTEUR~U2218AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0277526	04/29/2007	CA	68.0	68		M	04/29/2007	Heart palpitations (PAC); perpetual, severe rhinitis, fatigue, worsening insomnia.  7/17/07 Received medical records which reveal patient experienced palpitations upon awakening 11/17/06.  Seen in ER that day & d/c to home.  Holter monitor done 11/22/06 revealed 1 PVC & occasional PACs.  Cardiology consult done 11/28/06 revealed patient w/high anxiety& no treatable cardiac disease.  FINAL DX: palpitations & anxiety.								Y	N	11/01/2006	11/20/2006	19	CAT scan showing severely inflamed turbinates; treadmill test, echo cardiogram, Holter monitor showing irregular heartbeat.  No previous significant history of either main symptom.	UNK	UNK	Ambien, Ativan; various dietary supplements	None	Moderate sleep apnea; primary insomnia; discogenic disease PMH: adenomatous polyps, chronic rhinitis, BPH, palpations.			1						1	Computerised tomogram abnormal; Condition aggravated; Echocardiogram; Electrocardiogram ambulatory abnormal; Exercise electrocardiogram; Fatigue; Insomnia; Palpitations; Rhinitis; Supraventricular extrasystoles	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0277662	05/01/2007	AL	44.0			M	04/16/2007	MEDI-0005739 is a serious (Important Medical Event), spontaneous case from a 44-year-old male consumer involving atrial flutter. The patient indicated that he had been in excellent physical condition prior to developing atrial flutter. He denied having any relevant cardiac disorders in the past and denied having any family history of heart conditions. The patient indicated that he had been on Warfarin. it was unclear whether the above medication was started prior to developing atrial flutter or as a treatment of atrial flutter. The patient stated that he received FluMist either on 22-Oct-2006 or on 29-Oct-2006. Five days after receiving FluMist, the patient experienced atrial flutter which lasted for nearly ten hours. On the following day, the patient felt ill and developed a mild flu which lasted for the subsequent three weeks. During that time, the patient continued to experience intermittent atrial flutter. In early November 2006, the patient was seen by an internist for his symptom. An electrocardiogram revealed that the patient had the flutter. The patient was referred to a cardiologist. Stress test, echocardiogram and heart scan test results were all negative. The atrial flutter subsided and the patient did not experience any further problems. However, on 12-Mar-2007, the patient developed a stomach virus. And on 24-Mar-2007, the patient had another 10 to 12 hour episode of atrial flutter. The patient indicated that the above symptom still persisted and that the symptom had been occurring nearly on a daily basis. The patient provided no causality assessment for the event of atrial flutter. Per 60 day follow up: Spoke with reporter via phone-states atrial flutter still ongoing-occurrs rarely-had only one episode since July 2007-last episode few weeks ago lasting only a few minutes-exercise induced-no other associated sxs-not currently on any cardiac meds-no other medical complaints.									N	10/01/2006	10/06/2006	5	Heart scan on unknown date negative Echocardiogram NI negative, EKG 11/06 confirmed the flutter, Stress Test NI negative.	UNK	UNK	Concomitant Drug (s) Not reported				MEDI0005739	1						1	Atrial flutter; Cardiac stress test; Electrocardiogram; Gastroenteritis viral; Influenza; Malaise	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0277683	05/01/2007	CA	5.0	5		M	11/27/2006	Pt inadvertently given MMR #3, instead of Varivax #2 no physical signs/symptoms									Y	11/07/2006				PVT	PUB						1						1	No adverse effect; Wrong drug administered	FLU3~SANOFI PASTEUR~U2169PA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0254F~UNK~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0277689	05/01/2007	NV	74.0	73		M		Where shot went in between the shoulder and elbow on right arm.										10/01/2006				PUB	UNK		sugar, high blood pressure				1						1	Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0277760	05/02/2007	WA	4.0	4		M	04/27/2007	Large red area on left thigh - warm to the touch - 5 x 3.				Y						04/24/2007	04/24/2007	0	None	PVT	UNK	None	None	None			1						1	Injection site erythema; Injection site warmth	DTAP~SANOFI PASTEUR~C2554AA~5~~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~7103~3~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0324~4~~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~ME1169F~2~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0277766	05/02/2007	WY	21.0	21		F	05/02/2007	Raised Red Bumps on back and behind armpits which showed one day after patient recieved yellow fever and influenza vaccine.  Patient is also taking oral typhoid.									U	04/27/2007	04/28/2007	1		PUB	PVT	None	None	None			1						1	Rash	FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TYP~BERNA BIOTECH, LTD.~unknown~1~PO~MO~TYPHOID LIVE ORAL TY21A (VIVOTIF)~1|YF~SANOFI PASTEUR~ue945aa~1~SC~RA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0277824	05/03/2007	NC	1.0	1	.0	F	04/29/2007	Patient received vaccines and later the next day broke out in a big rash that later became petechiae. Had several days hospitalization. Patient had severe swelling in legs and arms and was unable to walk for several days. 06/05-07-records received from facility for DOS 12/20/06-ER visit-DX allergic reaction-purpura. edema. Previously seen on 12/6/06 one day after vaccine with purpura and swelling, presents on 12/20/06 with continued swelling and purpura on legs. Treated with benadrl and oraped. Mother states swelling has returned. Patient scratches at rash. No fever, vomiting, diarrhea, change in activity, eating well.  PE: extremities non-tender no effusions no edema, skin has edema non-pitting. Number of areas of papules and purpura on arms legs and face. Torso not involved							Y		Y	12/05/2006	12/06/2006	1	None records received 6/5/07-Lab and urine studies normal.	PVT	OTH	None	None	None			1						1	Abasia; Oedema peripheral; Petechiae; Rash; Urticaria	FLU3~SANOFI PASTEUR~U2271AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB093BA~1~~RL~HEP A (HAVRIX)~1|MMRV~MERCK & CO. INC.~0833F~1~~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Hospitalisation	Influenza
0277892	05/04/2007	OH	42.0	42		M	04/27/2007	Initial report received from a health care professional on 02 November 2006. A 42 year old, male patient experienced pain and paraesthesia after he received an injection of Fluzone (lot number U2194AA) in the left deltoid (route and date of administration not reported). The pain was severe that he took Vicodin. The patient was referred to a neurologist. At the time of the report, the patient did not recover. Follow-up information received on 27 December 2006. Fluzone SV 2006-2007 was administered intramuscularly on 16 October 2006. Immediately post-vaccination, the patient experienced numbness and tingling of the chest wall and arm pain. The patient continues with pain. He had improved markedly and then symptoms reappeared. He was treated with therapy, a prednisone dose pack, and Darvocet. Unspecified x-rays were negative, and an EMG was negative. The patient was to follow-up with a neurologist. At the time of this report, the patient had not recovered. Follow-up information received on 20 April 2007. The patient had an EMG performed on 17 November 2006. The referring neurologist had the following impression: Musculoskeletal pain with a suggestion of possible very subtle brachial neuritis which was completely improved. The EMG nerve conduction study did not show any suggestion of neuritis when done. He has a very subtle left arm median neuropathy as seen in carpal tunnel syndrome. This would require further follow-up before any interventions. This case is upgraded to serious adverse event internally based on follow-up information.				Y					N	10/16/2006	10/16/2006	0	EMG performed on 17 November 2006. The EMG nerve conduction study did not show any suggestion of neuritis when done.	PVT	PVT	PRILOSEC, COLOCHINE		GERD, Gout		200602922	1						1	Carpal tunnel syndrome; Electromyogram normal; Hypoaesthesia; Immediate post-injection reaction; Musculoskeletal pain; Neurological examination abnormal; Neuropathy; Pain in extremity; Paraesthesia; Radiculitis brachial; X-ray	FLU3~SANOFI PASTEUR~U2194AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0277907	05/04/2007	IL	8.0	8		F	02/05/2007	Patient received 11/1/06 started with rash 11/2/06 - admit to hosp 11/2-11/3 dx with hsp with arthritis. Later developed hematuria and proteinuria hsp nephritis with nephrotic syndrome. Required renal biopsy. Tx with Prednisone an then Cellcept. Pt also hypertensive requiring Isradipine and Lisinopril.  5/8/07 Received medical records from reporter/provider which reveal patient experienced rash & pain of her buttocks & legs w/swelling of her ankles & knees on 11/2/06  Hospitalized 11/2/06 for HSP.  Rash, pain & swelling improved but continued as of 11/20/06.  Labs revealed hematuria/proteinuria.  Patient had slight weight gain, HTN & decreased albumin.  During this time patient also had several severe nosebleeds & blood noted in stool.  Patient readmitted to hospital on 11/27/06 for kidney biopsy.  Continued to experience HTN & headaches severe enough to be seen in ER.  6/29/07 Received hospital medical records which reveal patient experienced HSP beginning 11/2/06 & was admitted to hospital 11/27-11/29/06 due to worsening creatinine & albumin for a renal biopsy & eval & treatment.  Treated w/steroids & low Na diet.  Initial eval in Renal Clinic 11/22/06 note reveals patient developed purpura, arthritis & abdominal pain on 11/2 following 2 days of LE pain & cramping.  Fatigue, pallor & blood in stools developed few days prior to initial eval along w/puffiness esp of eyes & LEs.  FINAL DX: Henoch-Schonlein purpura nephritis; nephrotic syndrome; s/p left renal biopsy. 1/4/2010 At the time patient off medicaton but still being followed closely by nephrology.					Y	5			N	11/01/2006	11/02/2006	1	Creatine 1.0 - improved now; low albumin 1.4 - improved now; renal biopsy cresents and necrosis; proteinuria, hematuria; increased cholesterol; renal ultrasound LABS: renal US, renal biopsy revealed only 10-15% of crescent formation & necrosis of glomeruli.	PVT	PVT	None	None	None			1						1	Arthritis; Biopsy kidney; Biopsy kidney abnormal; Blood albumin decreased; Blood cholesterol increased; Blood creatine decreased; Haematuria; Henoch-Schonlein purpura; Hypertension; Necrosis; Nephritis; Nephrotic syndrome; Proteinuria; Rash; Ultrasound kidney	FLU3~SANOFI PASTEUR~U2239AA~3~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0277979	05/04/2007					U	04/12/2007	This case was reported by a healthcare professional and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with Flulaval for prophylaxis. On an unspecified date the subject received unspecified dose of Flulaval (unknown). At an unspecified time after vaccination with Flulaval, the subject experienced injection site reaction, nausea, vomiting and pain. At the time of reporting the outcome of the events was unspecified. The reporter is a wholesaler and a clinic reported to him that every staff member received Flulaval and each person experienced an event. The reporter had limited information. He thought that the Flulaval was all the same lot number.													unknown	OTH	OTH		unknown			A0638048A	1						1	Injection site reaction; Nausea; Pain; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601211~UNK~~~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0277980	05/04/2007	TX	42.0			M	04/12/2007	This case was reported by a healthcare professional and described the occurrence of injection site pain in a 42 year old male subject who was vaccinated with influenza virus vaccine (Flulaval) for prophylaxis. There was no concurrent medications or relevant medical history. The subject had received influenza vaccination previously and had not experienced any adverse events. On an unspecified date between December 2006 and early January 2007, the subject received an unspecified dose of Flulaval (0.5 ml, unknown, right arm). At an unspecified time after vaccination with Flulaval, the subject experienced severe pain at injection site, nausea, fever, aches and pain, and pharmaceutical product complaint. The subject consulted with his healthcare provider as a result of the events. The events lasted for three days. The reporter indicated that there were approximately six other patients who received the same lot of Flulaval who experienced the same adverse events. The reporter requested a credit for the remaining 86 Flulaval vials he had in stock, which were from the same lot. At the time of reporting the outcome of the events were was unspecified.				Y									unknown	OTH	OTH	no concurrent medication	unknown	There was no relevant medical history. The reporter indicated that there were approximately six other patients that received Flulaval from the same lot who reported the same adverse events (severe pain at injection site, nausea, fever, aches and pain) to him. See case id numbers: A0638433A, Ao638434A, A0638436A, A063437A and A0638438A.		A0638423A	1						1	Injection site pain; Nausea; Pain; Pharmaceutical product complaint; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601211~UNK~~~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0277981	05/04/2007	TX				U	04/12/2007	This case was reported by a healthcare professional and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with Flulaval for prophylaxis. On an unspecified date, on or prior to 05 February 2007, the subject received an unspecified dose of Flulaval. At an unspecified time after vaccination with Flulaval, the subject experienced severe pain at injections site, nausea, fever, aches and pain, and pharmaceutical product complaint. The events lasted for three days. The reporter indicated that there were approximately six other patients who									U				unknown	OTH	OTH		unknown	The reporter indicated hat there were approximately six other patients that received Flulaval from the same lot who reported the same adverse events (severe paing at injction site, nausea, fever, and aches and pain) to him. See case id numbers: A0638423, A0638434, A0638435A, A0638437A, and A063843A.		A0638433A	1						1	Injection site pain; Pain; Pharmaceutical product complaint; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601211~UNK~IN~NS~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0277982	05/04/2007	TX				U	04/12/2007	This case was reported by a healthcare professional and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with Flulaval for prophylaxis. On an unspecified date on or prior to 05 February 2007, the subject received an unspecified dose of Flulaval. At an unspecified time after vaccination with Flulaval, the subject experienced severe pain at injection site, nausea, fever, aches and, and pharmaceutical product complaint. The reporter indicated that there were approximately six other patients who received the same lot of Flulaval who experienced the same adverse events. The reporter requested a credit for the remaining 86 Flulaval vials he had in stock, which were from the same lot. At the time of reporting the outcome of the events were was unspecified.				Y					U				unknown	OTH	OTH		unknown	The reporter indicated that there were approximately six other patients that received Flulaval from the same lot who reported the same adverse events (severe pain at injection site, nausea, fever, and aches and pain) to him. See case id numbers: A0638423A, A0638433A, Ao638435A, A0638436A, A063847A, and A0638438A.		A0638434A	1						1	Injection site pain; Nausea; Pain; Pharmaceutical product complaint; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601211~UNK~~~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0277983	05/04/2007	TX				U	04/12/2007	This case was reported by a healthcare professional and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with Flulaval for prophylaxis. On an unspecified date on or prior to 05 February 2007, the subject received an unspecified dose of Flulaval. At an unspecified time after vaccination with Flulaval, the subject experienced severe pain at injection site, nausea, fever, aches and pain, and pharmaceutical product complaint. The reporter indicated that there were approximately six other patients who received the same lot of Flulaval who experienced the same adverse events. The reporter requested a credit for the remaining 86 Flulaval vials he had in stock, which were from the same lot. At the time of reporting the outcome of the events were as unspecified.				Y					U				unknown	OTH	OTH		unknown	The reporter indicated that there were approximately six other patients that received Flulaval from the same lot who reported the same adverse events (severe pain at injection site, nausea, fever, and aches and pain) to him. See case id numbers: A0638423A, A0638433A, A0638434A, A0638436A, A0638437A, and A0638438A.		A0638435A	1						1	Injection site pain; Nausea; Pain; Pharmaceutical product complaint; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601211~UNK~~~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0277984	05/04/2007	TX				U	04/12/2007	This case was reported by a healthcare professional and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with Flulaval for prophylaxis. On an unspecified date on or prior to 05 February 2007, the subject received an unspecified dose of Flulaval. At an unspecified time after vaccination with Flulaval, the subject experienced severe pain at injection site, nausea, fever, aches and pain, and pharmaceutical product complaint. The reporter indicated that there were approximately six other patients who received the same lot of Flulaval who experienced the same adverse events. The reporter requested a credit for the remaining 86 Flulaval vials he had in stock, which were from the same lot. At the time of reporting the outcome of the events were was unspecified.				Y					U				unknown	OTH	OTH		unknown	The reporter indicated that there were approximately six other patients that received Flulaval from the same lot who reported the same adverse events (severe pain at injection site, nausea, fever, and aches and pain) to him. See case id numbers: A0638423A, A0638433A, A0638434A, A0638435A, A0638437A, and A0638438A.		A0638436A	1						1	Injection site pain; Nausea; Pain; Pharmaceutical product complaint; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601211~UNK~~~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0277985	05/04/2007	TX				U	04/12/2007	This case was reported by a healthcare profession and described the occurrence of injection site pain in a subject of unknown age and gender who was vaccinated with Flulaval for prophylaxis. On an unspecified date on or prior to 05 February 2007, the subject received an unspecified dose of Flulaval. At an unspecified time after vaccination with Flulaval, the subject experienced severe pain at injection site, nausea, fever, aches and pain, and pharmaceutical product compliant. The reporter indicated that there were approximately six other patients who received the same lot of Flulaval who experienced the same adverse events. The reporter requested a credit for the remaining 86 Flulaval vials he had in stock, which were from the same lot. At the time of reporting the outcome of the events were was unspecified.				Y					U				unknown	OTH	OTH		unknown	The reporter indicated that there were approximately six other patients that received Flulaval from the same lot who reported the same adverse events (severe pain at injection site, nausea, fever, and aches and pain) to him. See case id numbers: A0638423A, A0638433A, A0638434A, A0638435A, A0638436A, and A0638438A.		A0638437A	1						1	Injection site pain; Nausea; Pain; Pharmaceutical product complaint; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601211~UNK~~~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0277986	05/04/2007	TX				U	04/12/2007	This case was reported by a healthcare professional and described the occurrence of injection site pain in a subject of unknown age and gender who was vaccinated with Flulaval for prophylaxis. On an unspecified date on or prior to 05 February 2007, the subject received an unspecified dose of Flulaval. At an unspecified time after vaccination with Flulaval, the subject experienced severe pain at injection site, nausea, fever, aches and pain, and pharmaceutical product complaint. The reporter indicated that there were approximately six other patients who received the same lot of Flulaval who experienced the same adverse events. The reporter requested a credit for the remaining 86 Flulaval vials he had in stock, which were from the same lot. At the time of reporting the outcome of the events were was unspecified.				Y					U				unknown	OTH	OTH		unknown	The reporter indicated that there were approximately six other patients that received Flulaval from the same lot who reported the same adverse events (severe pain at injection site, nausea, fever and aches and pain) to him. See case id numbers: A0638423A, A0638433A, A0638434A, A0638435A, a0638436A, and A0638437A.		A0638438A	1						1	Injection site pain; Nausea; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601211~UNK~~~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0277968	05/06/2007	PR	21.0	21		M	05/06/2007	Muscle pain, joint pain, unexplained rashes.									Y	11/02/2003	03/14/2005	498		MIL	MIL						1						1	Arthralgia; Myalgia; Rash	ANTH~UNKNOWN MANUFACTURER~~UNK~IM~RA~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~ID~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~ID~RA~HEP B (NO BRAND NAME)~1|SMALL~UNKNOWN MANUFACTURER~~UNK~ID~LA~SMALLPOX (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~IM~RA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0278023	05/07/2007	WV	1.0	1	.1	F	02/21/2007	2/21/07-Mother called and stated that her daughter-(14 mths) received 3 vaccines on 2/6/07. She states her daughter had a reaction to vaccine and was told by her pediatrician to report reaction to health dept. First noticed 3 red dots on shoulder above vaccine site. Pt has been breaking out sporadically on face, neck and legs with chickenpox. Pt ran fever of 103F on 7th day after injection mother took child to doctor on 2/20/07 to examine rash.				Y					Y	02/06/2007	02/08/2007	2		PUB	PUB	None	None	None		WV0702	1						1	Injection site rash; Pyrexia; Varicella	FLU3~SANOFI PASTEUR~U22001CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~1350F~1~SC~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08674B~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0278025	05/07/2007	TX	12.0	12		M	04/30/2007	Hives, Cluster of 2 patients (patient identification provided) with generalized hives throughout the entire body, after receiving Adacel (lot number C2631AA); Fluzone (lot number unknown) and Menactra (lot number U1922AB); received from a health care professional in the USA on 24 April 2007. Case 1: A 12 year old, male patient (with a history of no known allergies) developed generalized hives throughout the entire body, 2 months after she received Adacel (lot number C2631AA), Fluzone (lot number unknown) and Menactra (lot number U1922AB) on 15 February 2007. He has the influenza vaccine annually. The patient denies any illness or medications at the time of the vaccinations. He was treated with Cortisone, Singular and Atarax. It was reported the hives resolved and the patient recovered. The second case ( the patient's sister) is detailed in Case 2007-01400.				Y					Y	02/15/2007	04/16/2007	60		PVT	PVT			History of no know allergies. He has the influenza vaccine annually.		200701399	1						1	Urticaria	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U1922A~2~IM~~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2631A~UNK~IM~~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0278026	05/07/2007	TX	11.0	11		F	04/30/2007	Hives, cluster of 2 patients (patient identification provided) with generalized hives throughout the entire body, after receiving Adacel (lot number C2631AA); Fluzone (lot number unknown), and Menactra (lot number U1922AB), received from a health care professional in the USA on 24 April 2007. Case 1: An 11 year old, female patient ( with a history of no known allergies) developed generalized hives throughout the entire body, 1.1/2 months after she received Adacel (lot number C2631AA); Fluzone (lot number unknown), and Menactra (lot number U1922AB) and Gardasil (Merck, lot number 0014U ) on the 15 February 2007. She has the Fluzone vaccine annually. The patient denies any illness or medications at the time of the vaccinations. She was treated with Cortisone, Singulair and Atarax. It was reported the hives resolved and the patient recovered. The second case  (the patient 's brother ) is detailed in case 2007-01399.				Y					Y	02/15/2007	04/05/2007	49		PVT	PVT			History of no known allergies. She has the Fluzone vaccine annually.		200701400	1						1	Urticaria	FLU3~SANOFI PASTEUR~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0014U~UNK~UN~UN~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U1922A~UNK~IM~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2631A~UNK~IM~UN~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0278041	05/07/2007	DE	6.0	6		F	04/13/2007	Red blotching rash around IPV injection site small area of redness around Dapt injection site. Local erythematous reaction to IPV									Y	12/05/2006	12/05/2006	0	none	PVT	PUB	Singulaire; Loratadine	Loose stools	Allergic Rhunitis			1						1	Injection site erythema; Injection site rash; Local reaction	DTAP~SANOFI PASTEUR~C2521AA~5~~LL~DTAP (DAPTACEL)~1|FLUX~UNKNOWN MANUFACTURER~42510AA~3~~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~SANOFI PASTEUR~Y1067~4~~LL~POLIO VIRUS, INACT. (POLIOVAX)~1|MMRV~MERCK & CO. INC.~0301f~1~~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0278153	05/08/2007	AZ	32.0	32		F	11/07/2006	Numbness down (R) arm to hand. Felt woozy in the car; passed out after returning home, fell on floor; was unconscious for 2 hrs. Developed H/A, knot on her head. Took Advil, better next day.									Y	11/03/2006	11/07/2006	4	negative; afebrile	PVT	PVT	Amocicillin, Albuterol, MDl, Armour Thyroid	Vaginitis, Sinusitis	Hypothyroidism; Allergic to Cipro	vomiting~Diphtheria Toxoids (no brand name)~5~7.00~In Sibling		1						1	Body temperature; Dizziness; Fall; Head injury; Headache; Hypoaesthesia; Injection site anaesthesia; Laboratory test normal; Loss of consciousness	FLU3~SANOFI PASTEUR~02165PA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0278155	05/08/2007	TN	0.6	0	.6	M	05/03/2007	4/16/07 acute vomiting, stomach pains - screaming seen in ER and fever and Diarrhea ? Paralytic Ileus  GI consult - Bilious Emesis and concern for intussusception and flims/KUB normal s/p enema with good results.  07/02/2007 MR received for hospital stay 4/19-21/2007.  Infant developed intermittant, severe abdominal pain (evidenced by back arching and screaming) and emesis 5 days prior to admission.  Seen in ER x 2 for above and progression to bilious vomiting and acting lifeless.  2nd ER visit with DX of constipation and enema given with improvement initially.  Symptoms reoccured and child was admitted. Barium enema succesfully reduced intussusception.  Feeding, stooling, and voiding well post procedure. DX: c/w Intussusception.				Y	Y	2			Y	12/13/2006	04/15/2007	123	WBC - 11.45, Hem - 11.5, HCT:34.2, and Platelets 431, CRP - 1.0, NA - 138, K+ - 4.4, chloride - 99, CO2 - 18, Glucose - 91, Bun - 10, creatinine - 04, LFTs - normal ABD. Films, KUB, Barium Enema.  Labs and Diagnostics: Abdominal X-rays x 3-normal.  Barium enema which showed a filling defect at hepatic flexure c/w intussusception.	PVT	PVT		none	none. PMH: none. NKDA.			1						1	Abdominal X-ray; Abdominal pain upper; Barium enema; Blood chloride; Blood creatinine; Blood glucose; Blood potassium; Blood urea; C-reactive protein increased; Carbon dioxide normal; Diarrhoea; Ileus paralytic; Intussusception; Laboratory test; Liver function test; Platelet count; Pyrexia; Screaming; Vomiting; White blood cell count; Abdominal pain upper; Blood chloride normal; Blood creatinine normal; Blood glucose abnormal; Blood potassium normal; Blood sodium normal; Blood urea normal; C-reactive protein normal; Diarrhoea; Enema administration; Haematocrit normal; Haemoglobin increased; Ileus paralytic; Inappropriate schedule of drug administration; Intussusception; Liver function test normal; Platelet count increased; Pyrexia; Screaming; Urinary system X-ray; Vomiting; White blood cell count increased	FLU3~SANOFI PASTEUR~42174RA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|RV5~MERCK & CO. INC.~1034F~3~PO~MO~ROTAVIRUS (ROTATEQ)~1|FLU3~SANOFI PASTEUR~42174RA~2~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|RV5~MERCK & CO. INC.~1034F~3~UN~UN~ROTAVIRUS (ROTATEQ)~2	USA	Hospitalisation	Influenza
0278230	05/08/2007	PA	0.64	0	.6	M	05/08/2007	T/C from parent on 5/8/07 reporting rash all over infants body, head to feet. Denies fever, reports some GI vomiting of formula. Had child evaluated by Dr. who dx. rash as reaction to flu#2 vaccine received on 5/1/07. Parent recalls that a mild rash followed the first flu shot administered back in March, but at that time was much less and she thought it was probably a heat rash and did not relate rash to vaccines received on 3-20-07 (Flu#1, Dtap#3, IPV#3, Prevnar#3)				Y					N	05/01/2007	05/06/2007	5		UNK	UNK						1						1	Rash generalised; Vaccination complication; Vaccine positive rechallenge; Vomiting	FLU3~SANOFI PASTEUR~U2191EA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB340AA~3~IM~LL~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0278299	05/09/2007	CA	27.0	27		M	05/09/2007	Sore throat, runny nose, fatigue, muscle aches.  Patient was in superb health until onset of symptoms resulting from the vaccine.									Y	05/02/2007	05/06/2007	4		MIL	MIL	NONE.	NONE.	NONE.			1						1	Fatigue; Myalgia; Pharyngolaryngeal pain; Rhinorrhoea	FLU3~SANOFI PASTEUR~U2308AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0278370	05/11/2007	VA	55.0	55		M	05/11/2007	CAME SICK, UPPER RESPITORY WITHIN 2 WEEKS/ CRONIC RETURN WITH SINUS PAIN AND BACK PAIN. STARTED HAVING PROBLEMS WITH TEETH/ POSSIBLE BEGINNING OF ABCESSED. PLACED ON ANTIBIOTICS/FLONAISE LATER ORDERED XRAYS FOR BACK (NEG) PATIENT HAS RECEIVED ONLY TWO FLU VAC IN PAST 30 YEARS. FIRST WHILE IN MILITARY DURNING 1976 SWINE FLU PANDEMIC AND WAS ORDERED TO RECEIVE VACINE. AND ON 10/17/2006 DUE TO PATIENT HIGH RISK TYPE 1 (INSULIN DEPENDENT) AVIAN FLU PANICDEMIC CONCERNS FOR UPCOMING FLU SEASON.  5/22/07 Received hospital medical records which were test results:  3/30/07 myocardial perfusion scan was WNL & unchanged from 10/05; 5/3/07 CT of c-spine revealed mature interbody fusion C6-C7, degenerative changes & posterior longitudinal ligament ossification combined w/congenitally fairly narrow canal cause spinal stenosis C4-C5 through C6-C7; 5/3/07 CT of head was WNL;5/9/07 MRI t-spine was WNL.  06/08/2007 Received medical records from 2nd hospital which consisted of Endocrinology consult of 6/5/07 & operative report of C4-5 cervical diskectomy of 6/5/07.  Consult indicates patient had NIDDM for 12-14 years after a bout of pancreatitis & had been on insulin x 2 years w/erratic control & peripheral neuropathy.  Recent cardiac cath revealed small lesions w/30% proximal stenosis in obtuse marginal branch of the left circumflex artery & had an ejection fraction of 60%.   Patient is a smoker of 1 1/2 pks/day & is enrolled in smoking cessation course.  Had a recent URI.  6/12/07 Received PCP medical records which consisted only of lab reports which reveal high triglycerides & cholesterol.			Y	Y	Y		Y	Y	N	10/20/2006	10/28/2006	8	MULTIPLE PROCEDURS AND SUDIES INCLUDING HEART CATH, STRESS TEST, CAT SCAN (SHOWS MASSIVE DAMAGES TO ALL C DISK'S INCLUDING T-1 THRU T-4 CURRENTLY SCHEDULED FOR MELLOGRAM WITH INJECT AND SPINAL FLUID STUDY ON 5/17/07 AT HOSPITAL.  TO BE SCHEDULE FOR SURGERY WITH NERO SURG ASAP RESULTS..WILD PHYS CHANGES DAILY/ BLOOD SUGARS WILD FLUX AND BARELY CONTROLLABLE..LOW AS 40 AND HIGH AS +500 (MONITOR WOULD NOT REGISTER ..CAME BACK HI WITH BEEP WARNING!!  BLODD SUGARS HISTORY BEEN MONITORED EVERY 2 HOURS OR SOONER WHEN PHYS CHANGES OCCURRED....SUDDEN SWEATS AND SHAKEY....SUGARS RECORDED TO DROP AS MUCH AS 100 + POINTS WITHIN 15 TO 30 MINS TIME FRAME.	UNK	UNK		LONG CRONIC HISTORY OF NEROLOGICAL AND AUTO-INMUNE (DYPE 1 DIABETIC) INSULIN DEPENDENT.  LONG HISTORY OF GI DISEASES INCLUDING GALL BLADDER REMOVAL, COLITIS, DIV, IBS, JOINTS PROBLEMS...5 KNEE SUGERIES IN PAST 9 YEARS (2LEFT AND 3 RIGHT)  RIGHT SHOULDER SURGERY, ANKLE SURGERY, GALL BLADDER SURGER, COLONOSTOPHY EVERY TWO YEARS WITH POLYPS REMOVAL EACH TIME OF 2 TO 4 BENIGN RESULTS.  HYPERTENSION / CURRENTLY HAVING PROBLEMS CONTROLLING BLOOD PRESSURE SINCE OCT 2006 TO CURRENT. HAS RANGED IN 150 OVER 60'S TO 190'S OVER 90'S ...AVG MEANS AROUND 170'S OVER 80'S	PATIENT CRONIC HISTORY STATES STARTED IN LATER YEARS WHILE IN MILITARY FROM APRIL 1971 THRU APRIL 1978...DEVELOPED HYPERCLYCEMIA WITH SLIGHT TREND TO TYPE II DIABETES. DEVELOPED HYDAL HERNIA WITH ACID REFLUX....WHICH CONTINUES TODAY.  HOST OF OTHERS   PMH: pancreatitis, C6-7 cervical fusion, HTN, dyslipidemia, GI bleed, GERD & stable pulmonary nodules.	FLU LIKE SYPM~Meningococcal Conjugate (Menactra)~~25.20~In Patient		1						1	Back pain; Blood glucose abnormal; Cardiac stress test; Catheterisation cardiac; Computerised tomogram abnormal; Sinus headache; Tooth disorder; Upper respiratory tract infection	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0278371	05/11/2007					U	05/11/2007	This case was reported by a nurse, and described the occurrence of influenza in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date, the subject received unspecified dose of Flu vaccine (unknown). The reporting nurse did not have the name of the Flu vaccine that was administered. At an unspecified time after vaccination with Flu vaccine, the subject experienced influenza and lack of efficacy. It was reported that the subject died from the flu, however, it was unknown which strain of flu the subject died from. It was unknown whether an autopsy was performed. No further information was provided at the time of reporting.	Y								N				UNK	OTH	OTH		Unknown	The subject's medical history, concurrent conditions, and concurrent medications were not reported.		A0650661A	1						1	Death; Influenza; Vaccination failure	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0278532	05/14/2007	SC	27.0	27		M	05/08/2007	Swollen upper extremities bilaterally and Bilateral ankle swelling. Noticed symptoms after receiving immunizations.				Y					Y	04/19/2007	04/20/2007	1	CBC/Diff, LFT panel, Health panel, Nuclear AB, Rheumatoid factor	MIL	MIL	Pfizer, Zithromax	Healthy	NKDA			1						1	Full blood count; Joint swelling; Oedema peripheral; Rheumatoid factor	FLU3~SANOFI PASTEUR~U2310AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB091CA~1~~LA~HEP A + HEP B (TWINRIX)~1|MNQ~SANOFI PASTEUR~U2106AA~1~~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TD~SANOFI PASTEUR~U1950CA~1~~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0278547	05/14/2007	AZ	30.0	30		F	05/10/2007	Service member had flu-like symptoms after her first anthrax vaccine, otherwise did not experience significant local or prolonged systemic symptoms following her anthrax vaccines 1-4. Service member received the Flumist vaccine in November 2005 and did not experience any local reaction (intranasally) or prolonged systemic symptoms until August 2006. At that time, she developed arthralgias, fatigue, and migraine headaches. She was diagnosed with SLE in Sept 2006 and is currently being treated by a Rheumatologist. She takes Plaquenil, Prednisone, and as needed Percocet. She is pending a neurology evaluation of her headaches.				Y					N	11/19/2003			Oct 2006, CRP 12.6; ANA 1:320; Smith Ab Positive; RNP Ab Positive; ESR 23 (0-23);  Nov 2006; Histone Ab 1.4	MIL	MIL	Prevacid	none				1						1	Antinuclear antibody positive; Arthralgia; C-reactive protein increased; Fatigue; Histone antibody positive; Influenza like illness; Migraine; Red blood cell sedimentation rate increased; Systemic lupus erythematosus	ANTH~MICHIGAN DEPT PUB HLTH~FAV078~4~SC~UN~ANTHRAX (NO BRAND NAME)~1|FLUN3~MEDIMMUNE VACCINES, INC.~U1916AA~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0278593	05/15/2007	OH	21.0	21		M	05/08/2007	07May07 Body covered with hives. Went to ER. received steroids, Benadryl at 2200 released at 0500 08May07. Member still has hives and was given script for Prednisone				Y						05/05/2007	05/06/2007	1		MIL	MIL			NKDA			1						1	Urticaria; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2199AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1160F~3~IM~LA~HEP B (RECOMBIVAX HB)~1|HEPA~MERCK & CO. INC.~1278F~3~IM~LA~HEP A (VAQTA)~1|FLU3~SANOFI PASTEUR~u2199AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|HEP~MERCK & CO. INC.~1160F~UNK~UN~UN~HEP B (RECOMBIVAX HB)~2|HEPA~MERCK & CO. INC.~1278F~UNK~IM~UN~HEP A (VAQTA)~2	USA	Emergency room visit	Influenza
0278822	05/16/2007	VT	68.0			F	05/14/2007	Information has been received from a 68 year old female consumer with hypersensitivity to many products and a history of fibromyalgia in December 2006, was vaccinated SC with a dose of Zostavax. Concomitant vaccination included influenza virus vaccine (unspecified). Other concomitant therapy included Nexium and thyroid medications. In January 2007, the patient experienced radiating pain from spinal column and headache. At the time of report the patient was not recovered from symptoms. No diagnostic laboratory procedures were undertaken. A product quality complaint was not involved. Additional information has been requested.				Y					N	12/01/2006	01/01/2007	31	None	OTH	OTH	(therapy unspecified) NEXIUM	Hypersensitivity	Fibromyalgia		WAES0704USA02200	1						1	Headache; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~SC~~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0278858	05/17/2007	MD	76.0	76		M	05/17/2007	Patient reported being in his relatively normal state of health until he received a flu vaccination at a roadside stand.  He alleged that approximately 2-3 days after this vaccination he developed worsening weakness, altered mental status and trouble breathing.  The patient was taken to hospital via EMS on 11/21/06 where he was found to be in acute respiratory failure.  The patient was admitted and during the patient's 14-day stay, he underwent multiple treatments & tests.  The patient's condition was treated medically and his condition progressively improved to the point of discharge to a rehab facility on 12/04/06.  Upon chart review and discussions with the patient's physicians, it was believed that the patient's condition might have been caused by the flu vaccination he allegedly received in mid-November.  No information is known as to where the patient received the alleged flu vaccination or the exact administration date.  While hospitalized the patient described the location of the vaccination as a roadside stand.   5/25/07 Received hospital medical records which reveal patient experienced altered mental status & not feeling well for approx 5 days, body aches & malaise w/decreased oral intake & problems walking, difficulty breathing & increasing confusion.  In ER patient was hypoxic on RA, O2 applied, was lethargic & extremely dry, wheezing & tight lungs, distended abdomen & was disoriented.  A presumptive dx of infectious delirium & acute renal failure was made & started on IV antibiotics after cultures.  Admitted to ICU, 11/21/06-12/4/06.  Treated w/continued IV antibiotics, IV steroids & inhalers.  Neuro consult felt bilat LE weakness c/w GBS s/p flu vax.  Heme, GI & Pulm consults done.  Progressed & was transferred to rehab facility on continued nasal O2 with PT/OT.  FINAL DX: COPD, oxygen dependent; pneumonia, distal weakness, possible GBS; HTN; BPH; mild acute renal failure, resolving; abnormal LFTs, resolved; thrombocytopenia, resolving; essential tremor.				Y	Y	14			Y	11/18/2006	11/21/2006	3	While hospitalized, a cardiac echo and multiple blood & radiological tests were performed. LABS: on admit WBC 15, Hgb 14.1, plts 388. Na 134, BUN 43, creatinine 3, glu 234, AST 95, ALT 129, alb 3.3.  UA was WNL.  CXR & CT of head were WNL.  ABG revealed severe hypercapnic respiratory failure. US of abdomen was WNL.	UNK	UNK	Flomax, Vasotec, Avodart, Ambien		Hypertension, BPH PMH: HTN, BPH, essential tremor			1						1	Acute respiratory failure; Asthenia; Blood test; Dyspnoea; Echocardiogram; Mental status changes	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0278859	05/17/2007	CA	51.0	51		M	05/17/2007	Tingling in feet that progressed to hands. This began sometime in December of 2007 (cannot remember exact date).  Did NOT require hospitalization. Saw Dr. (neurologist) at hospital who diagnosed GBS based on EMG, nerve conduction study. Is recovering, still has some tingling in feet. Neurology note dted 2/207-Impression clinical and electrodiagnostic studies document the presence of mainly sensory polyneuropathy. Involving both motor and sensory fibers coming on relatively abruptly and reaching a plateau after just 1-2 wekks and then stabilizing is strongly suggestive of mild form of Guillain-Barre syndrome. C/O paresthesia in left foot and migrating to right foot and then into the hands.				Y					Y	11/07/2006	12/05/2006	28	EMG, nerve conduction study	UNK	UNK	Timoptic 0.5% eye drops, Prusopt 2% eye drops, Brimonidine Tartrate 2% eye drops for glaucoma	none	Glaucoma-- diagnosed about 8 years ago			1						1	Electromyogram; Nerve conduction studies; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~7+~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~AHAVB109EA~2~~~HEP A (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0279173	05/17/2007	MN	20.0			F	05/14/2007	Information has been received from a Registered Nurse (R.N.) concerning her 20 year old daughter who on 03-JAN-2007 was vaccinated with a first dose 0.5 mL of Gardasil. Concomitant therapy included influenza virus vaccine (unspecified) and tetanus toxoid given in opposite arm where the Gardasil was given. On 03-JAN-2007 the patient experienced pain in the arm (which arm unknown) after receiving the first injection. As of 09-APR-2007 the patient had not received the second dose of Gardasil. Unspecified medical attention was sought. On 04-JAN-2007 the patient recovered. Additional information has been requested.				Y					Y	01/03/2007	01/03/2007	0	Unknown	OTH	OTH			Unknown		WAES0704USA01334	1						1	Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~1~UN~UN~HPV (GARDASIL)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~UN~UN~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0278973	05/18/2007	HI	1.5	1	.5	M	04/28/2007	Facial edema.  07/17/2007 MR received for admission 3/18-22/2007 for c/o persistant high fever. Pt initially developed eye swelling and an erythematous rash around his eyes.  The following day erythema and swelling of the L hand and fingers were noted which then progressed to involve the entire forearm.  Fever developed and child was seen outpt for possible cellulitis vs allergic rxn vs immunization reaction and then admitted. Child had resolution of rash and swelling with IV abx however fever persisited.   Consultation noted maculopapular eruption of a countable # of lesions on arms and legs. Assessment:  Fever and rash possibly due to a Varivax reaction with 2' strep invasion.  S/P Kawasaki disease, cannot r/o reactivation of that.  Eosinophilia, perhaps c/w an allergic rxn. Principal DX:  Resolved cellulitis of the L forarm and probable allergic rxn vs immunization reaction.					Y	4				03/10/2007	03/18/2007	8	Labs and Diagnostics:  C-Reactive Protein 1.1, ESR 36, Antinuclear antibodies (+). Blood culture (-) CBC with Eosinophils 1.6.	UNK	UNK			PMH: Kawasaki's.  Borderline ectasia of the L main coronary artery. RAD.  NKDA.			1						1	Face oedema; Inappropriate schedule of drug administration	DTAP~UNKNOWN MANUFACTURER~~UNK~~~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|MMRV~MERCK & CO. INC.~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0279027	05/20/2007	PA	27.0	27		F	05/20/2007	Guillain-[[name]] Syndrome, Bell's Palsy.  7/2/07 Received pcp medical records which reveal patient experienced her usual state of health on day of vax.  RTC on 10/21 w/facial assymetry & droop.  Dx at that time was CVA 7/3/07 Received hospital medical records which reveal patient admitted initially on 10/21-10/23 for severe migrain & left facial weakness, Bells Palsy, uncontrolled HTN, NIDDM, R/O CVA.  Neuro consult obtained.  MRI/MRA wer WNL.  HTN becamed controlled, Bells Palsy tx w/prednisone & anti viral med.  At d/c had continued difficulty closing left eye & had left facial asymmetry but had improved.  Readmitted 11/3-11/10/2005 due to arm & leg weakness. Neuro consult done & revealed muscle weakness & areflexia of LEs.  Tx w/IVIG & improved at d/c to outpatient f/u w/continued eye patching, outpatient PT/OT & neuro f/u. FINAL DX: Guillain [[name]] syndrome, left Bells Palsy. 1/4/10 Gullian [[name]] Syndrome left me with sever chronic fatigue and muscle weakness. Also Bell's Palsy left me with mild facial disfigurment, chronic eye watering and facial tick.				Y	Y	8		Y	N	10/07/2005	10/20/2005	13	Spinal tap used to diagnose GBS LABS from PCP: 10/7/05 free testosterone elevated at 7.8 otherwise all WNL.  X-rays of cervical, thoracic & lumbar spine 10/7/05 were WNL. Hosp LABS: CSF glucose 95 & protein 303, c/s neg.  Stool tests neg.  Electrolytes were essentially WNL except for glucose of 185.  WBC 15.  Multiplel other labs were WNL.  CT of head was WNL. EMG revealed generalized demyelinating sensory neural motor polyneuropathy c/w GBS.	UNK	UNK	Metformin, Inderal LA, Zoloft, Ortho-tricyclen LO	none	Depression/Anxiety, type 2 diabetes, migraines PMH: herniated disc L4-5, migraines, NIDDM, obesity, hearing loss, anxiety, panic disorder, lumbago, adjustment disorder w/depression, CTS, breast hypertrophy, fatigue, insomnia, muscle weakness, allergic rhinitis, restless leg syndrome,			1						1	Cerebrovascular accident; Facial palsy; Facial paresis; Fatigue; Guillain-Barre syndrome; Head deformity; Hypertension; Lacrimation increased; Lumbar puncture; Occupational therapy; Physiotherapy; Tic	FLU3~GLAXOSMITHKLINE BIOLOGICALS~A125AC~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation,Disabling	Influenza
0279089	05/21/2007					F	05/21/2007	This case was reported by a consumer and described the occurrence of Guillain Barre syndrome in a female subject of unspecified age who was vaccinated with influenza virus vaccine (Influenza vaccine) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Influenza vaccine. At an unspecified time after vaccination with Influenza vaccine, the subject experienced Guillain Barre syndrome. This case was assessed as medically serious by manufacturer. At the time of reporting the outcome of the event was unspecified.									U				UNK	OTH	OTH		Unknown			A0652010A	1						1	Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0279133	05/21/2007	SD	40.0	40		F	05/16/2007	Injection was given a little high - diagnosis - poked rotator cuff				Y					Y	10/20/2006	10/21/2006	1		OTH	PVT		none				1						1	Incorrect route of drug administration; Rotator cuff syndrome	FLU3~SANOFI PASTEUR~U2216AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0279144	05/21/2007	PA	65.0	65		F	05/03/2007	1-24-07 arm pain 3-15-07 c/o pain an swelling, hot, red, swelling									N	12/05/2006	12/06/2006	1	3-20-07 x Ray - Normal, 5-1-07 u/s - Normal	PVT	PVT	Atenolol, Accupril			~Influenza (Seasonal) (no brand name)~~64.00~In Patient		1						1	Erythema; Pain in extremity; Skin warm; Swelling; Ultrasound scan normal; X-ray normal	FLU3~SANOFI PASTEUR~U2189AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0279145	05/21/2007	NC	1.1	1	.1	M	05/11/2007	5mm diameter scar on R mid - thigh									N	03/12/2007	03/13/2007	1		PUB	PUB	None	None Known	Former 29 week preemie with resolved GERD, hip deformity, decreased visual acuity, eczema			1						1	Scar	FLU3~SANOFI PASTEUR~U2271AA~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1015F~3~~LL~HIB (PEDVAXHIB)~1|MMRV~MERCK & CO. INC.~1350F~1~~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08672B~4~~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0279149	05/21/2007	CO	53.0	48		F	05/12/2007	Myalgia, diffuse arthralgia									N	12/07/2006	12/07/2006	0	CBC, Sed rate, ANA, RA etc -	PVT	UNK						1						1	Antinuclear antibody negative; Arthralgia; Full blood count; Myalgia; Rheumatoid factor negative	FLU3~SANOFI PASTEUR~2281AA~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0279269	05/22/2007	CA	39.0	39		M	02/03/2007	Difficulty breathing - resolved by 3L O2 and Albuterol breathing treatment vital signs stable, O2 Sat 94% on room air after 1 hour.									Y	02/03/2007	02/03/2007	0		PVT	OTH		Asthma exacerbation	ASTHMA			1						1	Dyspnoea; Oxygen saturation decreased; Oxygen supplementation	FLU3~SANOFI PASTEUR~U2193AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0886F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0279287	05/22/2007	TX	43.0	43		F	05/22/2007	Within approx. 18 hours of receiving  immunizations, patient developed generalized urticaria with slight chest tightness.  Patient applied Caladryl and Calamine lotion all over body.  Patient given Prednisone 60-60-40 x 3 and 20 x 3.  To return to clinic if no better and to avoid TDAP in the future.									U	05/21/2007	05/22/2007	1	None	UNK	UNK	Acyclovir prn, Hydrocodone prn	None	Herpes simplex, arthritis			1						1	Chest discomfort; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70618~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~MERCK & CO. INC.~0020U~1~IM~LA~HEP A (VAQTA)~1|TDAP~SANOFI PASTEUR~C2731AA~1~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0279291	05/22/2007	MN	17.0	17		F	05/22/2007	generalized weakness, difficulty walking, photophobia, nausea.  Started one hour after vaccine administered, lasted rest of day.  Was gone the next morning.  Occurred with first vaccine on 11-22-06 and with the second vaccine on 1-25-07.  Also, after second vaccine only she vomitted one time.									Y	11/22/2006	11/22/2006	0	none, patient did not seek medical attention since it resolved on its own.  She reported symptoms 5-22-07 when she presented to get her 3rd vaccination. 3rd shot not given.	PVT	PVT	ortho evra	uti	amoxicillin, latex allergies, recurrent uti's			1						1	Asthenia; Gait disturbance; Nausea; Photophobia; Vomiting	FLU3~SANOFI PASTEUR~62244aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0688f~1~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0279295	05/22/2007	PR	20.0	20		M	05/22/2007	Migraine after shots for treatment they give me valproic acid. Lower back pain and joint pain treatment. Lower back pain and joint pain sometime treatment nothing.  05/2007 MR received for several OVs betweem 3/2/06 and 2/9/07.  Initial ER visit for c/o worsening back pain and headaches.  Sx began while pt. was overseas.  PE WNL except for pt. being overweight, tenderness at the R low back area and some swelling to the muscles of the low back noted. Weight-loss and excercise suggested. Multiple  F/Us for same. Refered to PT.   Problem list: Osteoarthritis involving the spine.  Discogenic Disease.  Chronic Headache.  Obesity.  Hypertension. Addendum: Pt. states that the life threatening illness is that he will have these problems for life.			Y					Y	N	12/04/2003	05/12/2004	160	Migraine, lower back pain and joint pain, lower back pain and joint pain. Labs and Diagnostics: X-rays of Lumbosacral spine 3/2/06-normal.  Lumbar MRI 5/8/06 shows discogenic and degenerative disease.	MIL	MIL		NONE	NONE. PMH: Chronic Lumbago, Chronic headaches.  NKDA.			1						1	Arthralgia; Back pain; Migraine	ANTH~EMERGENT BIOSOLUTIONS~FAV083~4~IM~RA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~U0905FA~3~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~UNKNOWN MANUFACTURER~UNK~1~ID~LA~SMALLPOX (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~UNK~1~IM~UN~TETANUS TOXOID (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~UNK~1~IM~UN~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Life Threatening,Disabling	Influenza
0279312	05/23/2007	CA	18.0	18		M	05/18/2007	Initial report received on 10 May 2007 from the patient's parents. A healthy 17-year-old male patient with no concurrent illnesses, no known allergies or past medical history, had received a right arm dose of FLUZONE SV '2005-2006' USP, lot number U1882AA on 28 November 2005 while in the military. The patient denied any previous adverse events with any prior vaccinations. His last vaccinations were given in August or September (type of vaccine, date and year not provided). The following day after receiving the influenza vaccination, the patient woke up with swelling of his eyes which decreased by mid-day. He complained of nausea and abdominal pain. The mother reported the patient had gained 30 pounds. Ten days later, the patient had developed a scaly, pruritic rash on palmar aspect of left hand and was evaluated by a medic and treated with topical steroid cream. At that time, the patient's weight was documented as being 25 pounds above his baseline. As insect bite was considered, but there was no visible evidence of a bite. Within two weeks post-vaccination, the patient's buddies had difficulty waking him up in the mornings, he had begun snoring, had continued swollen eyes each morning, gained greater than 20 pounds and his urine was foamy. On 18 December 2005, 20 days post-vaccination, the patient was admitted to the military hospital for vomiting and acute abdominal pain (10/10). He was afebrile and had ascites with abdominal distention and tenderness. The patient also had bilateral pleural effusion. Laboratory data revealed white blood cell count 8.2, creatinine 1.3, total protein 3.8, albumin 0.9, A/G ratio 0.3, AST 49, GGT 8, and LDH 205. The electrolytes, ALT, and bilirubin/alk phos were all normal. Three liters of fluid was drained from the abdomen and the patient underwent emergent appendectomy, biopsy of small bowel, and removal of a small portion of the large intestine. Per the reporter, analysis of the ascites fluid, appendix and small bowel were all negative. The patient was released from the hospital. On 23 December 2005, 25 days post-vaccination, the patient presented to a civilian hospital with diffuse edema, dyspnea, weight gain, and was admitted and diagnosed with overt nephrotic syndrome and kidney failure. At that time, his urine protein was 130 grams/24 hours. A renal biopsy performed in December 2005, revealed while several of the segmental lesions are tip lesions, other segmental lesions are not as well defined and may include perihilar sclerosis, so while the features are most consistent with a tip lesion, variant of FSGS (focal segmental glomerular lesions), this lesion is considered FSGS,NOS (not otherwise specified). There is no evidence for an acute glomerulonephritis or immune complex-related conditions. The tubulointerstitial and vascular compartments appear normal( through arteries are not well sampled). Sometime in December 2006, the patient was started on hemodialysis. The patient was subsequently transferred to another facility sometime in January 2006, with anasarca, 4+ weeping edema of the lower extremities and cellulitis, periorbital edema, and bilateral pleural effusion with bibasilar atelectasis. During the first three weeks at this facility, the patient was treated with intravenous steroids, Cyclosporine, intravenous albumin, Lasix and antibiotics. After treatment, the patient's edema and weight dramatically improved. The patient was subsequently released from the hospital. Despite further treatment, the patient's kidney disease steadily declined to chronic kidney disease stage V. On 30 March 2007, 122 days post-vaccination, the patient was emergently admitted to the hospital with fluid overload, respiratory distress (oxygen saturation 94%) and malignant hypertension. Five liters of fluid was removed from the patients body. Per the reporter, the patient's currently received dialysis three to four times a week and continues with myalgia, new onset migraines, pleural effusions, insomnia, anuria, abdominal pain, fatigue, and recurrent rashes. The patient has severe straie from the whole body edema. Per the reporter, the patient suffered pulmonary edema, chest pain, abdominal pain and cough from a delay in dialysis treatment, pitor, lisinopril, losartan, nephrocap (nephrocaps), Zantac and atenolol. The patient is being considered for possible kidney transplant. The patient has not recovered.   1/26/09 Received medical information from VHC from 2007. FINAL DX: end stage renal disease, dialysis dependent & awaiting transplantation secondary to focal segmental glomerulosclerosis. Records reveal patient experienced bilateral eye lid swelling 1 day after flu shot 11/28/05; dry scaly rash on had/fingers; hand swelling; 26# wt gain by 12/8/05; difficult to arouse, trouble running, foamy urine approx 2 wks s/p vaccination; abdominal pain & vomiting 12/18 & presented to ER.  Appendectomy done & 3L of fluid removed from abdomen.  Symptoms evolved to progressively worsening swelling & abdominal pain diagnosed as nephrioic syndrome w/anasarca approx 1 mo after vacccination.  Condition deteriorated w/multiple re-hospitalizations & started hemodialysis 12/2006. Continued w/N/V/D, HTN, abdominal pain, myalgias, arthralgias, difficulty sleeping, HA, anuric, chronic rashes & urticaria, extreme fatigue.					Y		Y	Y	N	11/28/2005	11/29/2005	1	Laboratory data revealed white blood cell count 8.2, creatinine 1.3, total protein 3.8, albumin 0.9, A/G ratio 0.3, AST 49, GGT 8, and LDH 205. The electrolytes, ALT, and bilirubin/alk phos were all normal. The latest laboratory data reveals creatinine 9.8 and urine micro albumin 140,784.   LABS: CT abdomen abnormal.  Total protein 3.8(L), albumin 0.90(L), alk phos 80(L), ALT 49(H), GGT 8(L), LD 205(H).  Urine protein 130G/24hr(H).  Renal biopsy c/wFSGS.	MIL	MIL	minocidil (minoxidil), felopipine (felodipine), Li		Patient denied any illness at the time of vaccination on 28 November 2005. The patient has no known allergies, no use of supplements, no use of other medications or any medical conditions prior to vaccination on 28 November 2005. The last vaccines the patient received was in August or September (type of vaccine, date and year not provided). The patient denied any previous adverse reactions to any prior vaccinations.  PMH: allergy: sulfa & morphine.  Seasonal allergiesNo reactions to prior vaccines.  FAMILY HX: parent w/polycystic kidney disease on dialysis.		200701692	1						1	Abdominal distension; Abdominal pain; Abdominal tenderness; Albumin globulin ratio; Albumin urine; Anuria; Appendicectomy; Ascites; Aspartate aminotransferase increased; Atelectasis; Biopsy; Biopsy kidney abnormal; Blood albumin decreased; Blood bilirubin normal; Blood creatinine increased; Blood electrolytes; Blood lactate dehydrogenase increased; Cellulitis; Chest pain; Cough; Dyspnoea; Eye swelling; Fatigue; Fluid overload; Generalised oedema; Haemodialysis; Insomnia; Large intestine operation; Malignant hypertension; Migraine; Myalgia; Nausea; Nephrotic syndrome; Oedema; Periorbital oedema; Pleural effusion; Protein total decreased; Pulmonary oedema; Rash; Rash pruritic; Renal failure; Renal failure chronic; Respiratory distress; Skin exfoliation; Skin striae; Snoring; Somnolence; Surgery; Tenderness; Urine analysis abnormal; Urine protein, quantitative; Vomiting; Weight increased; White blood cell count normal	FLU3~SANOFI PASTEUR~U1882AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0279314	05/23/2007					U	05/18/2007	Initial information received on 10 May 2007 as a result of a literature abstract that was acquired secondary to the report from a patient's parent (separately reported case). Per the citation, We describe four cases of leucocytoclastic vasculitis following influenza vaccination. The four patients, who were all elderly, presented with cutaneous vasculitis but all had abnormal urinalysis suggestive of associated renal involvement. Additional information was not reported. The reporter in this case is the same as for case 2007-01692.				Y					U					UNK	UNK					200701779	1						1	Cutaneous vasculitis; Leukocytoclastic vasculitis; Renal disorder; Urine analysis abnormal	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0279316	05/23/2007	OH	46.0	46		F	04/11/2007	Fisher variant of Guillian Barre with ataxia, L6th, L5th, accommodation, also R tract lesion with L periph visual loss L>R eye.  6/12/07 Received hospital records from provider which included consults, ER records, labs & x-ray reports as well as provider notes & vax record.  Returned to office on10/13 w/complaints of right ear pain & tx w/drops but worsened & was placed on antibiotics 10/16/06.  Seen 10/23 for med adjustments.  Returned on 12/13/06 for left eye visual field deficit for approx 4-5 mos & for last 6 weeks numbness on left cheek.  Returned to office 12/19/06 w/worsened vision loss left eye, vision loss comes/goes & occasionally was blinded in left eye. Trigeminal nerve weakness noted.  Referred to neuro opthamologist who dx w/fisher variant of GBS.  Vision improved.  On 4/11/07 returned to office stating had lost vision completely for 90 min approx 1 mo earlier & had been having a lot of double vision & seeing spots.  Opth thought ocular migraine (hx ocular migraine).  Neuro consult indicates that patient experienced flu-like symptoms for about 3 weeks s/p flu shot & prior to developing vision problems.  Continued w/ gait & balance disturbance, fatigue,  & resolving droopy left eyelid.  Neuro could not provide dx other than possibly early MS.  Patient seen in ER on 12/18/06 for severe HA, pressure behind left eye & tingling on left side of face. FINAL DX: Fisher variant of Guillian Barre syndrome.				Y					U	10/06/2006			Several MRI's all WNL, See attached labs.  LABS: MRI of brain 12/18/06 revealed nonspecifid subcortical white matter changes.  CT of brain 12/18/06 was WNL.  LP was neg.	PVT	PVT	HCTZ, Actonel, Prevacid	Fibromyalgia	Increased chol, Fibromyalgia, Osteopenia PMH: elevated ANA 1:320 in 2002 w/arthralgias & cold intolerance; hypercholesterolemia & hyperlipidemia; fibromyalgia; insomnia; osteopenia; ocular migraines; kidney stones			1						1	Coordination abnormal; Guillain-Barre syndrome; Nuclear magnetic resonance imaging normal; Visual field defect	FLU3~SANOFI PASTEUR~U2194AA~7+~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0273691	05/24/2007	NY	12.0	12		F	05/21/2007	Initial report received on 14 May 2007 from another manufacturer, report# WAES0703USA01477. The initial reporter to this manufacturer had been a health care professional . Verbatim from the report:Initial and follow up information has been received from a physician concerning a 12 year old adolescent female with a history of a developmental delay (NOS) who on 11-DEC-2006 was vaccinated intramuscularly in the right deltoid with the first dose of Gardasil (Lot# 654540/1163F). Concomitant therapy included mefloquine and Fluzone. Subsequently, on 21-DEC-2006 the patient had a seizure while at school. The seizure was described to include both eye rolling and loss of consciousness lasting than one minute. The patient went to the emergency room where a electroencephalography, magnetic resonance imaging and unspecified labs were completed. Results of all testing were normal/negative. On 21-DEC-2006 therapy with mefloquine was discontinued. On 19-FEB-2007 the patient received the second intramuscular vaccination of Gardasil (Lot# 655503/0012U) in the left deltoid. It was also reported that on 07-MAR-2007 while at home at the breakfast table the patient had a second seizure which lasted less than one or two minutes. It was reported by a physician that the patient did not have any illness at the time of vaccination and had no prior history of seizures. The physician reported that the patient had recovered from both seizures. Upon internal medical review, the seizures were felt to be other medical events. Additional information has been requested.				Y					Y	12/11/2006	12/21/2006	10	21/Dec/2006: EEG-normal 21/Dec/2006: MRI-normal	PVT	PVT	Mefloquine		The patient had a history of developmental delay.		200701736	1						3	Electroencephalogram; Nuclear magnetic resonance imaging; Convulsion; Vaccine positive rechallenge; Convulsion; Electroencephalogram normal; Gaze palsy; Laboratory test; Loss of consciousness; Nuclear magnetic resonance imaging normal	FLU3~SANOFI PASTEUR~u2166mA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1163F~1~IM~LA~HPV (GARDASIL)~1|HPV4~MERCK & CO. INC.~~2~UN~UN~HPV (GARDASIL)~2|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~3|HPV4~MERCK & CO. INC.~1163F~1~IM~RA~HPV (GARDASIL)~3	USA	Emergency room visit	Influenza
0279463	05/24/2007	NC	1.3	1	.3	F	01/05/2007	Child receive flu vaccine on 1-4-07 at 10:00 am. Child was put on Amoxicillin on 12-26-06. Mom noticed some bumps on child's inner thigh and this AM child's right knee was swollen and reluctant to walk. She has latex egg, egg products. Physicians diagnosis: allergic reaction with serum sickness like reaction. Patient came back in on 1-6-06. Patient is to follow up if no better.				Y					Y	01/04/2007	01/04/2007	0	ESR, Complete blood count	PVT	PVT	none	otitis media, URI	no known drug allergies-now allergic to Amoxicillin			1						1	Full blood count; Gait disturbance; Hypersensitivity; Joint swelling; Rash; Red blood cell sedimentation rate; Serum sickness	FLU3~SANOFI PASTEUR~UT2176CA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0279469	05/24/2007	FL	10.0	10		M	05/16/2007	Several lesions/spots inside (R) thigh, covering chest, some on head, arms and legs				Y					Y	03/01/2007	05/16/2007	76		PVT	PVT				~Varicella (Varivax)~2~10.00~In Patient		1						1	Skin lesion	FLU3~SANOFI PASTEUR~U2284AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1280F~2~IM~LA~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~1303F~3~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0280372	05/24/2007	NH	1.0	1	.0	F	05/16/2007	Information has been received from a registered nurse (RN) concerning an 18-month-old female with no pertinent medical history or allergies, who on 14-OCT-2005 was vaccinated subcutaneously with a dose of Varivax (lot# 648083/0072P). Concomitant vaccinations included MMR (manufacturer unknown), Hib conj vaccine (OMPC) (manufacturer unknown), influenza virus vaccine (unspecified) and concomitant therapy included sodium fluoride. On 27-APR-2006 the patient developed chickenpox with 40-50 lesions. She had a fever but it resolved. Unspecified medical attention was sought. No laboratory or diagnostic tests were performed. It was noted that two weeks prior to the rash, she was exposed to chickenpox and shingles. At the time of the report the patient had not recovered from the chickenpox. No product quality complaint was involved. Additional information has been requested.				Y					N	10/14/2005	04/27/2006	195	None	OTH	OTH	Sodium fluoride		None		WAES0605USA00196	1						1	Exposure to communicable disease; Pyrexia; Rash; Skin lesion; Varicella	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~UNK~UN~UN~HIB (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~0072P~UNK~SC~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0280994	05/24/2007	NJ	1.0	1	.0	F	05/16/2007	Information has been received from a registered nurse concerning a 22 month old female with a peanut allergy who on 16-SEP-2005, was vaccinated SC with a first dose of Varivax (Oka/Merck) (lot# 649270/0987P). Concomitant vaccination included a first dose of FLUZONE (lot# U1743JA) IM and a fourth dose of PREVNAR (lot# A56H7F) IM. There was no illness at the time of vaccination. On approximately 14-JUL-2006 the patient developed bilateral otitis media and an upper respiratory tract infection which were treated with AUGMENTIN ES-600 bid for 10 days, with improvement. On 18-JUL-2006 the patient developed a breakthrough rash described as vesicles filled with clear fluid on her left arm, left leg, and face. On 20-JUL-2006 the patient was seen in the office and the physician noted 10 pink papules, 2 vesicles, and no fever. The patient was seen in the office and the physician noted 10 pink papules, 2 vesicles, and no fever. The patient was diagnosed with a possible mild varicella. Supportive care was provided. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information is not expected.				Y					Y	09/16/2005	07/14/2006	301	Unknown	PVT	PVT		Peanut allergy			WAES0607USA04286	1						1	Blister; Otitis media; Rash papular; Upper respiratory tract infection; Varicella	FLU3~SANOFI PASTEUR~U1743JA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A56H7F~1~IM~~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0987P~1~SC~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0281606	05/24/2007	PA	13.0			F	05/16/2007	Information has been received from a registered nurse concerning her 13-year-old daughter with no pertinent medical history and no drug reactions/allergies who on 09-OCT-2006 at 17:00 was vaccinated SC with the second dose of Varivax (lot # 654030/0913F). Concomitant vaccination included influenza virus vaccine (unspecified). There was no illness at the time of vaccination. On 11-OCT-2006, 24 hours post vaccination, the patient experienced pain, swelling, redness (1.5 inch circle around the site), and itching at the injection site. Unspecified medical attention was sought. There were no lab diagnostic studies obtained. Additional information indicated that on 10-OCT-2006 at 15:00 the patient developed a large red wheal approximately 3 at the injection site with pain and redness and that was warm to touch and itchy. Subsequently the patient recovered. There was no product quality complaint. It was reported that at 5 years old the patient had a local reaction following the fifth dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. No additional information is expected.				Y					Y	10/09/2006	10/10/2006	1	None	PVT	PVT			None		WAES0610USA09272	1						1	Injection site erythema; Injection site pain; Injection site pruritus; Injection site swelling; Injection site urticaria; Injection site warmth; Reaction to previous exposure to any vaccine	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~0913f~2~SC~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0281801	05/24/2007	MA	1.0	1	.0	F	05/16/2007	Information has been received from a registered nurse concerning a 13 month old female with no allergies or medical conditions who on 06-OCT-2006 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (lot # 652666/0248F). Concomitant vaccination on the same day included a SC first does in the left thigh of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Winstar RA 27/3) (MSD) (lot # 650753/0971R), and an IM first dose on the right thigh of influenza virus splint virion 3v vaccine inactivated (FLUZONE) (lot # U2A8AA). There was no illness at the time of vaccination. On 06-NOV-2006, the patient was seen in the office and noted to have 50-75 scattered, red, raised papules on both legs. A few looked vesicular. She was afebrile. No diagnostic laboratory tests were performed. The patient recovered on 08-NOV-2006. Additional information is not expected.				Y					Y	10/06/2006	11/06/2006	31	body temp        11/06/06        afebrile	PVT	PUB			None		WAES0611USA06033	1						1	Blister; Body temperature; Erythema; Rash papular	FLU3~SANOFI PASTEUR~U2A8AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0971R~1~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0248F~1~SC~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0281803	05/24/2007		9.0	9		M	05/16/2007	Information has been received from a registered nurse concerning a 9-year-old male (brother 1 of 2) with seasonal allergies and amoxicillin allergy who on 17-NOV-2006 was vaccinated SC with a 0.5 mL dose of Varivax (Lot # 652450/0948R). Concomitant therapy included ALLEGRA. On 19-NOV-2006 the patient experienced a six-inch raised red sore area around injection site and sore area around the injection site. Unspecified medical attention was sought; treatment included TYLENOL and ice. No diagnostic studies were performed. NO additional information to report. There was no product quality complaint involved. It was also noted that the patient's brother was also vaccinated with Varivax on 17-NOV-2006 and experienced a raised red sore area around injection site and sore area around the injection site (WAES # 0611USA06138). Additional information has been requested.				Y					U	11/17/2006	11/19/2006	2	None	OTH	OTH	ALLEGRA		Seasonal allergy, penicillin allergy	injection site induration~Varicella (Varivax)~~10.00~In Sibling|injection site pain~Varicella (Varivax)~~10.00~In Sibling	WAES0611USA06125	1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~0948R~UNK~SC~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0281804	05/24/2007		10.0	10		M	05/16/2007	Information has been received from a registered nurse concerning a 10-year-old male with seasonal allergies and amoxicillin allergy who on 17-NOV-2006 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot # 652450/0948R). Concomitant therapy that day in the other arm included influenza virus vaccine (unspecified). Other concomitant therapy included unnamed nasal sprays and eye drops for allergies. On 19-NOV-2006, the patient experience a six-inch raised red sore area around the varicella virus vaccine live (Oka/Merck) injection site. Medical attention was sought; treatment included ice and acetaminophen (TYLENOL). No additional information to report. There were no lab diagnostic studies performed. There is no product quality compliant. It was also noted that the patient's brother was also vaccinated with varicella virus vaccine live (Oka/Merck) and experienced a six-inch raised red sore area around the injection site (WAES #0611USA06125). Additional information has been requested.				Y					U	11/17/2006	11/19/2006	2	None	OTH	OTH	cough, cold, flu therapies		Concurrent Conditions: Seasonal allergy; Penicillin allergy; Hypersensitivity	~Varicella (no brand name)~UN~9.00~In Sibling|~Varicella (no brand name)~UN~9.00~In Sibling	WAES0611USA06138	1						1	Injection site erythema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~0948R~UNK~UN~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0281808	05/24/2007	OH				U	05/16/2007	Information has been received from a physician concerning a patient who was vaccinated with a 0.5 ml dose of Varivax (lot# 654530/1046F). Concomitant therapy included a dose of  influenza virus vaccine (unspecified). Subsequently, the patient experienced a red, swollen arm and a fever. Unspecified medical attention was sought. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.				Y					N				Unknown	OTH	OTH			Unknown		WAES0611USA06413	1						1	Erythema; Oedema peripheral; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~1046F~UNK~UN~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0281820	05/24/2007	TX	1.0	1	.0	F	05/16/2007	Information has been received from a licensed visiting nurse (L.V.N.) concerning a 13-month-old female with a slight heart murmur who on 20-NOV-2006 at 10:00 was vaccinated subcutaneously with a 0.5 ml first dose of Varivax (lot# 654524/1042F). Concomitant vaccinations given on 20-NOV-2006 included: a dose of MMR II (lot# 654820/1027F) (MSD), a fourth dose of Prevnar given intramuscularly and a dose of influenza virus vaccine (unspecified). On 30-NOV-2006 at 11:30 the patient experienced a rash with clusters and erythema on her face and under the chin on her right side only. On 04-DEC-2006 she was seen in the physician's office and had small little clusters on her chin, her face and under her ear. The physician diagnosed her with shingles. No laboratory or diagnostic studies were performed. She was treated with calamine and calamine (+) camphor (+) pramoxine hydrochloride (AVEENO lotion). She recovered as of 06-DEC-2006. The VZVID program was offered. No product quality complaint was involved. Additional information has been requested.				Y					Y	11/20/2006	11/30/2006	10	None	PVT	PVT		Cardiac murmur			WAES0612USA00865	1						1	Erythema; Herpes zoster; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~1027F~1~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08646B~4~IM~UN~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1042F~1~SC~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0281842	05/24/2007	CA	1.1	1	.1	F	05/16/2007	Information has been received from a medical assistant concerning a 13 month old female with reactive airways disease and a history of frequent ear infections, who on 27-NOV-2006 was vaccinated SC in the leg (also reported as thigh) with a first dose of Varivax (lot # 654610/1049F). Concomitant vaccination included a fourth dose of Prevnar (lot # B08681F) given IM in the leg (also reported as thigh) and a first dose of Fluzone (lot # U2220BB) given IM in the leg (also reported as thigh). Concomitant medication included loratadine (CLARITIN0. There was no illness at the time of vaccination. On approximately 09-DEC-2006 the patient was seen in the physician's office for an unspecified reason, on the same date as a 4 month old infant with active varicella. On 13-DEC-2006 (also reported as 11-DEC-2006) the patient came in to the office with less than one dozen spots of varicella crops and crusted lesions visible on her trunk, in her mouth and on her lips. The patient was fussy, had a decreased appetite and had a low temperature (also reported as afebrile). It was reported that there were a few lesions with a honey colored crust and a few with the classic tear drop shaped blisters. It was reported that there was an active outbreak in this country. The patient was noted to have a laceration to the top of her phrenulum. The patient was treated with amoxicillin (AMOXIL) for prophylaxis. It was reported that the patient and her sibling had not had any adverse events followed prior vaccination (previously reported as the patient has experienced soreness and fever after previous vaccination with DTaP. No labs tests were performed, just a physical exam by the physician. Subsequently, on an unspecified date the patient recovered. No further information was available. Additional information is not expected.				Y					Y	11/27/2006	12/09/2006	12	None	PVT	PVT	Claritin	Reactive airways disease	Ear infection		WAES0612USA03274	1						1	Body temperature decreased; Decreased appetite; Irritability; Skin lesion; Varicella	FLU3~SANOFI PASTEUR~U2220BB~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08681F~4~IM~UN~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1049F~1~SC~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0281872	05/24/2007	PA	18.0	18		F	05/16/2007	Information has been received through the Merck pregnancy registry from a physician concerning an 18-year-old white female with no drug reactions/allergies and with a history of chickenpox (therefore the patient had immunity to varicella) who on 10-OCT-2006 was inadvertently vaccinated SC with a 0.5mL dose of Varivax (Lot # 654082/0916F) when she was 19 weeks pregnant. Concomitant therapy that day included a dose of influenza virus vaccine (unspecified). Titers showed the patient had a prior immunity to varicella. It was noted that the physician ordered Varivax, and the nurse administered it. It was just human error. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that a the LMP=07-MAY-2006 (EDD=04-MAR-2007). On 25-JUL-2006, an ultrasound was obtained to check dates. On 22-SEP-2006, a MSAFB was obtained, and showed neg NTD, OS, Trils. On 18-OCT-2006, an ultrasound showed a 20.6 week male. The patient had no previous pregnancies, no full-term deliveries, and no pre-term births. There was no birth defects with any other pregnancy; no still birth or miscarriage in any previous pregnancy. The patient was not tested for varicella antibodies before vaccination with VZV containing vaccine. A liveborn male infant was born on 18-FEB-2007 (weight 7 pounds 2 ounces; 38 weeks from LMP). The infant was normal. There was no complications or abnormalities. There was no complications during pregnancy. There were no complications during labor/delivery. There were no infections or illnesses during pregnancy. There were no concurrent medical conditions. There was no feature of congenital varicella zoster syndrome. Diagnostic tests during pregnancy included: varicella zoster IgG=3.61 (positive IgG Ab=31.10); IgM=0.30 (0-0.90 Neg). Other medication used during the pregnancy included: PNV and ferrous sulfate from December 2006 325mg daily for anemia. No additional information is expected.				Y					Y	10/10/2006	10/10/2006	0	serum immunoglobulin G 3.61 - positive IgG Ab 31.10; serum immunoglobulin 3.0 - 0-0.90 neg	OTH	OTH			Chickenpox		WAES0701USA01913	1						1	Blood immunoglobulin G normal; Blood immunoglobulin M; Drug exposure during pregnancy	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~0916F~UNK~SC~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0281887	05/24/2007	DE	1.32	1	.3	M	05/16/2007	Information has been received from a consumer concerning her 16 month old perfectly healthy son with no known allergies who on 10-JAN-2007 was vaccinated in the left arm with a first dose of Varivax (Merck) (Lot #655065/1142F, product circular 7999915) (lot # also reported as M9108). Concomitant therapy included influenza virus vaccine (unspecified), Hib conj vaccine (unspecified carrier), hepatitis B virus vaccine (unspecified) and pneumococcal vaccine (unspecified). On 17-JAN-2007, the patient developed chicken pox around his mouth, eyes, chest, arms, and stomach. The patient's mother indicated that her son's condition was getting worse and worse since getting the vaccine. The patient sought medical attention and was treated with antibiotics (not further specified). As of 22-JAN-2007, the patient had not recovered. The product quality complaint unit is not involved. Additional information has been requested.  Additional information from a health care professional indicated that the patient had no past medical history and had no illness at the time of vaccination. It was reported that on 20-JAN-2007 the patient developed several vesicles at the injection site and on his face. Medical attention was sought, there were no lab tests performed. The patient recovered on 22-JAN-2007. It was reported that the patient and his sibling had no adverse events following prior vaccination. No further information was provided. Additional information is not expected.				Y					Y	01/10/2007	01/17/2007	7	None	PVT	OTH			Unknown; None		WAES0701USA03945	1						1	Injection site vesicles; Varicella; Wrong drug administered	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~MERCK & CO. INC.~~UNK~UN~UN~HEP B (RECOMBIVAX HB)~1|HIBV~MERCK & CO. INC.~~UNK~UN~UN~HIB (PEDVAXHIB)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1|VARCEL~MERCK & CO. INC.~1142F~1~UN~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0282088	05/24/2007		5.0	5		M	05/16/2007	Information has been received from a medical assistant concerning a 5 year old male, with no pertinent medical history, drug reactions or allergies, who on 19-OCT-2002 was vaccinated with his first dose of varicella virus vaccine live (Oka/Merck). On 09-MAR-2007 the child was vaccinated subcutaneously in the right arm with his second dose of varicella virus vaccine live (Oka/Merck), (Lot#654756/1335F). He also was vaccinated with hepatitis A vaccine (inactive) (MSD), and influenza virus vaccine live (unspecified) that same day. The child developed a red raised area at the injection site after vaccination on 09-MAR-2007. There was no treatment. No lab diagnostic studies were performed. The patient's status at the time of the report was not recovered. Unspecified medical attention was sought. There was no product quality complaint. The office requested a lot check on Lot#654756/1335F. This report is one report of five reported by the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2007. Information has been received from a medical assistant concerning a 5 year old male, with no pertinent medical history, drug reactions or allergies, who on 19-OCT-2002 was vaccinated with his first dose of VARIVAX (Merck). On 09-MAR-2007 the child was vaccinated subcutaneously in the right arm with his second dose of VARIVAX (Merck) (Lot # 654756/1335F). He also was vaccinated with VAQTA (inactive), and influenza virus vaccine (unspecified) that same day. The child developed a red raised area at the injection site after vaccination on 09-MAR-2007. There was no treatment. No lab diagnostic studies were performed. The patient's status at the time of the report was not recovered. Unspecified medical attention was sought. There was no product quality complaint. The office requested a lot check on lot # 654756/1336F. This report is one report of five reported by the same source. A review of the release testing data revealed that the lot in question conformed to all required testing at the time of product release. The lot complies with the standards of Center for Biologics Evaluation and Research and was released. No further information is expected.				Y					N	03/09/2007	03/09/2007	0	None	OTH	OTH	None		None	Welts~Varicella (Varivax)~2~7.00~Sibling	WAES0703USA01548	1						1	Injection site erythema; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~MERCK & CO. INC.~~UNK~UN~UN~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~1335F~2~SC~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0282089	05/24/2007		1.85	1	.8	F	05/16/2007	Information has been received from a medical assistant concerning a 22 month old female with a medical history of behavior issues, but no drug reactions or allergies, who on 26-FEB-2007 was vaccinated subcutaneously in the left upper thigh, with her first dose of varicella virus vaccine live (Oka/Merck) (Lot#654756/1335F). She was also vaccinated with influenza virus vaccine (unspecified) that same day. On 06-MAR-2007 the patient experienced a red, raised and a little swollen area at the injection site. No lab diagnostic studies were performed. The patient's status at the time of the report was recovering. Unspecified medical attention was sought. There was no product quality complaint. The office requested a lot check on Lot#654756/1335F. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2007. The office requested a lot check on Lot # 634756/1335F. This report is one report of five reported by the same source. A review of the release testing data revealed that the lot in question conformed to all required testing at the time of product release. The lot complies with the standards of the Center and was released. No further information is expected. This is in follow-up to report (s) previously submitted on 5/16/2007.				Y					N	02/26/2007	03/06/2007	8		OTH	OTH	Unknown	Behaviour disorder			WAES0703USA01557	1						1	Injection site erythema; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~1335F~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0279709	05/25/2007	LA	53.0	51		M	05/16/2007	Pt felt nauseated on the first day of injection. Next day patient had shortness of breath and chest pain. Patient reported SOB lasted a couple of days. Pt reported wheezing and Fast heart beat on the second day as well									Y	12/16/2005	12/16/2005	0	Pt reports had EKG that was abnormal	PUB	PUB	unk	none	Asthmas		LA070502	1						1	Chest pain; Dyspnoea; Electrocardiogram abnormal; Heart rate increased; Nausea; Wheezing	FLU3~SANOFI PASTEUR~U1817AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0279842	05/25/2007	IL	1.0	1	.0	M	05/25/2007	Child received MMR and Influenza vaccine on 1/25/07. Developed seizures on 2/4/07 for which he was  hospitalized from 2/4/07 to 2/13/07. Regression of developmental occurred which are gradually returning with therapy.  07/17/2007 MR received for admission 2/23/2007.  Child presented with 10 day hx of fever with regression of developmental milestones. Pt had been hospitalized for new onset seizures 2/3/2007.				Y	Y	9			U	01/25/2007	02/04/2007	10	MRI abnormal hypersensitive bilat basal ganglia, CSF negative, Blood cultures, Urine CX negative.   Labs and Diagnostics:  head CT prominent sulci diffusely which may represent generalized cortical atrophy of unknown etiology. MRI brain with diffuse abnormality in the basal ganglia. MR spine shows thickening at L3-L4 interspinus gap. CXR normal. Sed rate 85. CK 31. HSV PCR (-).  Blood and CSF cultures (-). Throat culture Strep (-).	PUB	PUB	Xopenex HFA as needed	Mild URI	Prematurity, IUDE, hospitalized for RLTE< asthma, Ger, NKDA. PMH: sleep apnea, seizures, maternal cocaine use.			1						1	Blood culture negative; CSF culture negative; Convulsion; Culture urine negative; Developmental delay; Nuclear magnetic resonance imaging abnormal	FLU3~SANOFI PASTEUR~U2220AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0094FF~UNK~SC~UN~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1	USA	Hospitalisation	Influenza
0279825	05/27/2007	FL	52.0	52		M	05/27/2007	I was given two shots,one in each arm.That night I could not lie on either side becouse of the pain in my sholders.I thought it was becouse they were sore from the shots but the pain has remained every day and night since.Most of the time I cant raise my arms higher than my sholders and cannot sleep on my sides.I am writing becouse I saw something on TV about joint pain after having the flu shot.									N	12/17/2006	12/17/2006	0		PUB	UNK	Nexium 40mg,Nadolol 20mg,Folic acid 1mg,Furosemide 80mg,Spironolactone 50mg,Acidophilus,Thiamine 100mg.	None	cirrhosis of liver			1						1	Arthralgia; Injected limb mobility decreased; Musculoskeletal pain; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0279944	05/29/2007	KY	1.5	1	.1	F	05/23/2007	Pt came to clinic 5-14-07 with scattered papules in different stages of progression from small papules on an erythematous base to crusted ulcerated lesions Addendum: Pt came to clinic 5-22-07 with a superinfected chicken pox lesion on (L) shoulder 2.5 x 2.5 cm firm eryth. nodule									Y	12/13/2006	05/14/2007	152		PUB	OTH	5-22-07 Put on Clindamycin 75/5 (7 ml) po TID x 10 d	Bilateral Otitis Media				1						1	Localised infection; Nodule; Rash papular; Vaccination failure; Varicella	FLU3~SANOFI PASTEUR~UT2176KA~1~SC~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0651F~1~UN~RL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~1261F~1~UN~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08682E~4~UN~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0279996	05/30/2007	SC				M	05/23/2007	Shortly after receiving immunization, patient fell backwards while seated. Patient was unconscious and nonresponsive for 2-5 seconds. Patient was brought back with vigorous stern rub and complained of inability to breathe with a perception that throat was closing. Patient given Epinephrine and Benadryl. Patient very pale.				Y						05/23/2007	05/23/2007	0	None	MIL	MIL	None					1						1	Dyspnoea; Fall; Loss of consciousness; Pallor; Throat tightness; Unresponsive to stimuli	FLU3~SANOFI PASTEUR~U2285AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2106AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TD~SANOFI PASTEUR~U1944BA~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1|UNK~UNKNOWN MANUFACTURER~C2369AA~1~~RA~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0280060	05/31/2007	WI	53.0	53		F	05/31/2007	My left arm, where the vac. was given at a strange angle, has hurt ever since getting the vac. (like someone has punched me really hard in the upper left arm) and results in staggering pain and weakness in the left arm, with tingling like a funny bone being hit going down the whole arm and hand and fingers.  This has been going on ever since getting the vac. and increasingly getting worse.  An MRI was done that shows only age associated closing of the area in my cervical spine, but does not explain the weakness, pain and numbing sensations I experience every day.  I highly suspect it was the vaccination because that is when it begun.  I wonder if other people have had this reaction and wanted to report it. I also have broken out with sores all over my legs, buttocks, and now spreading to my arms... tried antibiotics, salves, creams, atavan.. not helping... Further information can only come from my clinic where I received the flu shot this past season. Exact date would have to be gotten from the clinic/doctor's office. 8/1/07-records received for DOS 8/3/06 and 6/25/07-C/O tingling numbeness in left arm.  1/4/10 Pain persist in upper left arm and symptoms in addition ot pain are; numbness, tingling, pain and itchiness going doe the arm and also thumb and index finger possible radial nerve was hit, I was told. Still seeing doctors for this.				Y				Y	N	11/15/2006	11/15/2006	0	an MRI was done to check my cervical spine with negligible results as far as explaining my symptoms.  Onset started with flu shot.	UNK	UNK	Nexium, Premarin, Depakote, Wellbutrin, Neurontin, Vikoden, Xanax, Zoloft, albuteral, hydrochlorazide, atonolol, tried some steroids.	Known and diagnosed:  Lupus Dermatitis, Barrett's esophagus, PKD, Fibromyalgia, asthma, High blood pressure, high cholesterol, HAD type II diabetes, Sleep Apnea, Bad back (L5 area and SI joint) feet bone spurs, arthritis, depression and anxiety.  Being treated for all of above.	see number 9:  also allergic to penicillin, sulfa, IVP dyes, macrodantin and velosef, shellfish. records received 8/01/07-PMX: Chronic back pain, fibromyalgia, lupus dermatitis, sleep apnea, asthma, polycystic kidney disease, Barrette's esophagus, depression, anxiety and IDS. Stomach stapling. Left knee surgery.			1						1	Cervical spinal stenosis; Hypoaesthesia; Injection site pain; Muscular weakness; Nuclear magnetic resonance imaging normal; Paraesthesia; Pruritus; Skin lesion	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0280091	05/31/2007	WA				F		Hepatitis B vaccine to be administered to newborn. Stored in same refrigerator, or nursing unit, as Fluarix. Products are in very similar box and syringes look almost identical. Fluarix was administered to newborn by mistake instead of Engerix-B.										05/04/2007				UNK	UNK						1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~HEP B (ENGERIX-B)~1	USA		Influenza
0280092	05/31/2007	WA		0	.0	F		Hepatitis B vaccine to be administered to newborn. Stored in same refrigerator, or nursing unit, as Fluarix. Products are in very similar box and syringes look almost identical. Fluarix was administered to newborn by mistake instead of Engerix-B.										05/04/2007				UNK	UNK						1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~HEP B (ENGERIX-B)~1	USA		Influenza
0280167	06/01/2007		69.0	68		F		On 11/Oct/2006, a report was received, via a company representative concerning a 69-year-old female vaccinee. No details were provided regarding the vaccinee's medical history or concomitant medications. On 08/Oct/2006 the vaccinee received 0.5ml Fluvirin (batch number G9427), intramuscularly. On the same day, 08/Oct/2006, the vaccinee experienced a swollen arm, which was described as a cellulitis type swelling, from her shoulder to elbow. The vaccinee refused to take Benadryl. The symptoms continue. The vaccinee takes the flu shot every year and has not had this reaction before. Follow-up information will be sought. Follow up information was received on 21/May/2007 from a healthcare professional. No details were provided regarding the vaccinee's medical history or concomitant medications. The vaccinee received Fluvirin on 08/OCT/2006, one day later (09/Oct/2006) the vaccinee developed abnormal  swelling from the wrist to the shoulder. The event was treated with Benadryl and resolved in approximately 1 week. The reporter considered the event to be serious, medically significant as it caused pain and stiffness to the affected arm. No further information is expected.										10/08/2006	10/09/2006	1		UNK	UNK	Concomitant drugs not reported.		The vaccinee takes a flu shot every year and has not had this reaction before.		CVOX200600146	1						1	Cellulitis; Musculoskeletal stiffness; No reaction on previous exposure to drug; Oedema peripheral; Pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69427~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0280168	06/01/2007		81.0	81		F		On 11/Oct/2006, a report was received, via a company representative, concerning an 81-year-old female vaccinee (initials VB, DOB 10/05/1925). No details were provided regarding the vaccinee's medical history or concomitant medications. On 08/Oct/2006 the vaccinee received 0.5ml Fluvirin (batch number 69427), intramuscularly. On the same day, 08/Oct/2006, the vaccinee experienced a swollen arm, which was described as a cellulitis type swelling, from her shoulder to elbow. The swelling improved with Benadryl, but there is still some swelling. The vaccinee takes the flu shot every year and has not had this reaction before. Follow-up information will be sought. Follow up information was received on 21/May/2007 from a healthcare professional. No details were provided regarding the vaccinee's medical history or concomitant medications. The vaccinee received Fluvirin on 08/Oct/2006, one day later (09/Oct/2006) the vaccinee developed abnormal swelling from the wrist to the shoulder. The event was treated with Benadryl and resolved in approximately 1 week. The reporter considered the event to be serious, medically significant as it caused pain and stiffness to the affected arm. No further information is expected.										10/08/2006	10/09/2006	1		UNK	UNK	Concomitant drugs not reported.				CVOX200600145	1						1	Cellulitis; Musculoskeletal stiffness; No reaction on previous exposure to drug; Oedema peripheral; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69427~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0280169	06/01/2007	CA	44.0	44		F		A report was received from a healthcare professional on 12/Oct/2006 concerning a 44 year old female vaccinee. The vaccinee has a history of allergies and sees and allergist. Allergy testing was negative for egg allergy. No details of concomitant medication were provided. On 10/Oct/2006 the vaccinee received Fluvirin by intramuscular injection. By the evening she had developed facial swelling and her eyes were swollen shut. She was treated the next day with a steroid injection and antihistamines, and the facial swelling resolved overnight. On 12/Oct/2006 the vaccinee reported bilateral low back pain radiating to her thighs, pain upon rising from a seated position and severe pain in the left wrist. The vaccinee is being treated with oral prednisone. Further information has been requested. Follow-up report was received on 22/May/2007 regarding this 44-year-old female vaccinee. The vaccinee has a history of anxiety for years for which she has been treated intermittently and which was discontinued on 04/Oct/2006 (concomitant drug unknown, illegible). The vaccinee received Fluvirin 0.5mls intramuscularly on 10/Oct/2006. The same day she developed facial and periorbital oedema, and a generalised pruritic rash which was consistent with urticaria, which resolved on 20/Oct/2006. On 12/Oct/2006 the vaccine awoke and was unable to walk. This had resolved on 18/Oct/2006 after treatment with prednisone. The reporter considered the events to be serious and medically significant (possible angioedema/anaphylaxis).  The events periorbital oedema and generalised pruritus were considered to be possibly related to Fluvirin. The causality of the inability to walk was provided as unknown. No further information is expected.										10/10/2006	10/10/2006	0		UNK	UNK	Concomitant drugs not reported.		History of allergies		CVOX200600162	1						1	Abasia; Anaphylactic reaction; Angioedema; Arthralgia; Back pain; Eye swelling; Gait disturbance; Periorbital oedema; Rash pruritic; Swelling face; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70735~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0280170	06/01/2007	OH	21.0	21		F	05/28/2007	Pt developed dermatomyositis over the few months following her mass vaccines for international travel (see attached history). Dermatomyositis is a rare, very serious autoimmune inflammatory muscle/skin disease. 1/5/10 Ongoing serious autoimmune conditions-deramatologists is still requiring subatartial daily immunoserppriadats (Celliept and Prednisone) as well as IVIg infurine mortally.  06/04/2007 VAERS report submitted with unsigned HPI attached.  Pt. initially experience low grade temps and fatigue for several days following multiple vax for foriegn travel in May 2005.  Upon returning from travel in 8/2005 pt. again experienced low grade temps and fatigue as well as bilateral shoulder and upper arm muscle aches and soreness as well as weakness. Skin flushing and pruritic nodules noted on wrists and elbows. By 9/2005 muscle symptoms and fatigue had increased as well as cuticle changes.  Txd with steroids, IVIG, Minocycline and topical creams to skin. DX: Dermatomyositis.  07/03/2007 MR received from neurologist for several visits beginning 8/28/2005 to 12/08/2005 for initial c/o profound weakness in the arms which was progressing. Pt also c/o hip pain and tightness as well as some skin irritation around the nail cuticle and skin discoloration of the chest area and knees. PE significant for minimal neck flexion weakness as well as minimal biceps/triceps weakness. Knee reflexes depressed. Skin discoloration noted at the cuticles, eyelids, knees.  DX: Dermatomyositis. Pt admitted to hospital 10/23/2005 for increasing weakness, swallowing difficulty and head/neck weakness r/t the dermatomyositis.  F/U 12/8/2005 doing well.			Y	Y	Y	2		Y	N	05/17/2005			Lab data-CKs; EMG; muscle biopsy. Labs and Diagnostics:  Muscle biopsy (+) for dermatomyositis. Labs and Diagnostics:  CK 3905.  ANA 1:640 (speckled). Anti-DS DNA 143. Aldolase elevated.  RF (-). ESR 6.  EMG and Muscle biopsy confirmed DX of Dermatomyositis.	UNK	PVT	none	none				1						1	Dermatomyositis; Electromyogram; Musculoskeletal discomfort; Dermatomyositis; Muscular weakness	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~IM~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MNQ~SANOFI PASTEUR~~2~IM~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TD~UNKNOWN MANUFACTURER~~2~IM~UN~TD ADSORBED (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~2~IM~UN~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|YF~UNKNOWN MANUFACTURER~~2~IM~UN~YELLOW FEVER (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1579AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|IPV~SANOFI PASTEUR~Y1241~UNK~SC~LA~POLIO VIRUS, INACT. (IPOL)~2|MNQ~SANOFI PASTEUR~U1493AC~UNK~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TD~UNKNOWN MANUFACTURER~Td-118~UNK~IM~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~2|TYP~SANOFI PASTEUR~Y0794~UNK~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~2|YF~SANOFI PASTEUR~UE347AA~UNK~SC~LA~YELLOW FEVER (YF-VAX)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0280286	06/04/2007	NC	4.0	4		M	05/29/2007	Child received immunizations at regular check up. Went to ER same day c/o something being in throat, voice change, throat & tongue swollen. Got IV fluids, Benadryl 7.5 mg, Solu medrol 30 mg IV. Epinephrine 1:1,000 0.15 ml SQ, Benadryl 7.5 IV. Sent home with Orapred 15 mg/5 ml 10 ml QD x 5 days.				Y					Y	10/20/2006	10/20/2006	0	Pulse oximetry 97-100%	PVT	PUB	none	none	none			1						1	Dysphonia; Oxygen saturation; Pharyngeal oedema; Swollen tongue; Throat tightness	DTAP~SANOFI PASTEUR~U1751CA~5~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2275AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1068~4~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0537F~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0283491	06/04/2007	NY	1.25			F	05/30/2007	Information has been received from a physician concerning a 15 month old female who on approximately 14-NOV-2006 was vaccinated with MMR II. Concomitant vaccinations included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and influenza virus vaccine (unspecified). Subsequently, the patient experienced rubella rash all over the body, mostly on the trunk and a few on the face and was irritable after receiving the vaccine. The patient sought medical attention. Additional information has been requested.				Y					U	11/14/2006	11/14/2006	0	Unknown	UNK	UNK			Unknown		WAES0611USA06100	1						1	Irritability; Rash generalised; Rubella	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0270507	06/06/2007	OH	2.17	2	.2	M	05/25/2007	Information has been received from an office manager concerning a 26-month-old male with no allergies or medical history who on 10-JAN-2007 at 14:00 PM was vaccinated in the lower left thigh with a 0.5 mL first dose of hepatitis A vaccine inactivated (lot # 654814/0804F). Concomitant vaccination at the same time included a fourth dose in the upper left thigh of DTaP (unspecified) (+) tetanus toxoid (lot # C2405AA), a second dose in the upper right thigh of Fluzone (lot # UT21763A), and a fourth dose in the lower right thigh of Prevnar (lot # B08670F1). There was no illness at the time of vaccination. On 12-JAN-2007, at 9:50 AM, the patient developed inflammation of 4 x 7 cm and induration of 2 x 4 cm at the injection site of hepatitis A. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. The patient had no adverse events following prior vaccination. A product quality complaint was not involved. Follow-up information was received from the office manager who reported that in the evening of 10-JAN-2007, the patient had redness on his left thigh. It had increased in size to a large area of erythema of 4 cm by 7.5 cm and an area of induration 2 cm by 4 cm. A doctor's visit was reported and the patient recovered on an  unspecified date. Additional information is not expected.				Y					Y	01/10/2007	01/10/2007	0	None	PVT	PVT			None		WAES0701USA01955	1						2	Injection site erythema; Injection site induration; Injection site erythema; Injection site induration; Injection site inflammation	DTAP~SANOFI PASTEUR~C2405AA~4~~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2176JA~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0804F~1~~LL~HEP A (VAQTA)~1|PNC~PFIZER\WYETH~B08670F~4~~RA~PNEUMO (PREVNAR)~1|DTAP~SANOFI PASTEUR~C2405AA~4~UN~UN~DTAP (DAPTACEL)~2|FLU3~SANOFI PASTEUR~UT21763A~2~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~MERCK & CO. INC.~0804F~1~UN~UN~HEP A (VAQTA)~2|PNC~PFIZER\WYETH~B08670F1~4~UN~UN~PNEUMO (PREVNAR)~2	USA	Emergency room visit	Influenza
0280891	06/07/2007	CA	1.75	1	.8	F	06/07/2007	Per mom child seemed in pain, gradually guarded her walking, avoided walking at times. Child refuses to bear weight or both legs. Able to crawl and move lower extremities normally. No fever, redness and swelling from IZ sites. Per mom stated better now than 3 days ago.				Y						05/29/2007	05/29/2007	0		PUB	PUB		None	None			1						1	Gait disturbance; Hypokinesia; Pain	FLU3~SANOFI PASTEUR~UT2175CA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0249H~1~IM~RL~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0281036	06/08/2007	IL	81.0	81		F	05/21/2007	Patient complains of soreness at injection site. Patient says soreness has lasted 6 months. Patient has seen her physician and has tried anti inflammatory medication.				Y					N	10/25/2006	10/26/2006	1		OTH	PVT						1						1	Injection site pain	FLU3~SANOFI PASTEUR~U2274AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0281118	06/11/2007	SC	24.0	24		M	04/17/2007	Patient felt dizzy and light-headed shortly after immunizations. After 5 minutes, he began throwing up. After an additional 2 minutes, he began breathing quickly and deeply. At this time he stated feeling short of breath.				Y					Y	04/17/2007	04/17/2007	0	NONE	MIL	MIL	Zithromax 1gm Suspension	none known	none known or aware of			1						1	Dizziness; Dyspnoea; Respiratory rate increased; Vomiting	FLU3~SANOFI PASTEUR~U2259AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2106AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~U1944BA~1~IM~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0281405	06/12/2007	LA	74.0	83		F	06/07/2007	Neuralgia - no treatment at present									U	11/01/2006	11/02/2006	1		PVT	OTH	Metformin, Altace, Zocor,  Glyburide	None	NKA: NIDDM			1						1	Neuralgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA221AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0675F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0280170	06/14/2007	OH	21.0	21		F	06/14/2007	Mother reported to me on this day that her daughter developed dermatomyocitis which started with muscle weakness in mid-June 2005.  She has already completed Vaers #280170										05/17/2005				UNK	UNK	Benzaclin gel, Malarone 250/100		History of neural hearing loss.			1						2	Dermatomyositis; Electromyogram; Musculoskeletal discomfort; Dermatomyositis; Muscular weakness	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~IM~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MNQ~SANOFI PASTEUR~~2~IM~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TD~UNKNOWN MANUFACTURER~~2~IM~UN~TD ADSORBED (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~2~IM~UN~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|YF~UNKNOWN MANUFACTURER~~2~IM~UN~YELLOW FEVER (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1579AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|IPV~SANOFI PASTEUR~Y1241~UNK~SC~LA~POLIO VIRUS, INACT. (IPOL)~2|MNQ~SANOFI PASTEUR~U1493AC~UNK~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TD~UNKNOWN MANUFACTURER~Td-118~UNK~IM~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~2|TYP~SANOFI PASTEUR~Y0794~UNK~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~2|YF~SANOFI PASTEUR~UE347AA~UNK~SC~LA~YELLOW FEVER (YF-VAX)~2	USA		Influenza
0281686	06/14/2007	MI	36.0	36		M	06/14/2007	Patient returned from deployment complaining of numbness of fingers and joints (including shoulders and hips), weakness, fatigue, slight memory loss, intermittent pain beginning within 24 hours of receiving vaccination. Seen initially by Dr. regarding symptoms and was referred to Orthopedic Specialist, Neurologist, and Immunologist.  Seen by Ortho on 25 May 2007, Impression: Polyathralgia, Bilateral rotator cuff tendonitis, muscle fasciculation; referred to neurology. Seen by  Neurology 7 Jun 2007, results pending; seen by Immunology 12 Jun 2007 results pending.									N	12/05/2006	12/06/2006	1	CBC, CBC w/Diff, RBC SED Rate, Rheumatoid Factor QNT, T4 Free, TSH, 3rd Generation, ANA*, ANA Pattern, ANA Titer*, Comprehensive Metab.PNL, *Lipid PNL Reflex Dir.LDL  * Abnormal Result	MIL	MIL	NONE	NONE	NONE	Flu-like symptoms~Anthrax (Biothrax)~2~32.30~Patient		1						1	Amnesia; Antinuclear antibody; Arthralgia; Asthenia; Blood thyroid stimulating hormone; Fatigue; Full blood count; Hypoaesthesia; Lipids; Low density lipoprotein abnormal; Metabolic function test; Muscle contractions involuntary; Pain; Red blood cell sedimentation rate; Rheumatoid factor; Rotator cuff syndrome; Thyroxine free	ANTH~EMERGENT BIOSOLUTIONS~FAV102~6~IM~LA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U2238AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0281700	06/14/2007	IN	33.0	33		M	06/14/2007	Dyspnea, wheezing, dull aches in thighs from his hip to his knee, along with weakness of hips.  Nonproductive cough, chest discomfort; hot and cold flashes started on 6/9/07; Oxygen sats 97% on 2 litres of oxygen; inspiratory wheezes, prolonged expiratory wheezes; no rash; Antibiotics used included Levaquin, Solumedrol, Relafen, Xoponex, Dexpax, Advair.  Symptoms started about 18 hours after vaccine given.  6/25/07 Received hospital med recs which reveal patient experienced dyspnea & wheezing, dull aches of thighs from hip to knee, hot/cold flashes, non productive cough & central chest discomfort beginning approx 18 hrs s/p vax.  Admitted 6/10-6/18/2007 when transferred to unknown higher level of care. Developed sacroiliac & lower back pain.  Continued to have DOE. T/C to reporter to request additional hospital info. V/M left for return call. LABS: WBC 10.9, peak at 27.9, lymphs low at 15, grans high at 91.  UA WNL.  ABG revealed pO2 60.  Normal EKG.  Mycoplasma pneumoniae IgG positive at 277, IgM negative.  Legionella, sputum & blood c/s were negative. FINAL DX: Reactive airway disease, arthralgias and probable reaction to anthrax vax. Per 60 day follow up: Continues to have SOB & arthralgia. Being followed by rheumatology. CHURG STRAUSS syndrome being ruled out.							Y		N	06/05/2007	06/06/2007	1	EKG was normal sinus rhythm.  Chest X-Ray normal.  Bilirubin above 1.6.	MIL	MIL	Has used inhaler in past.	None	Allergic to Penicillin.			1						1	Blood bilirubin increased; Blood gases abnormal; Blood immunoglobulin G; Blood immunoglobulin M; Chest X-ray normal; Chest discomfort; Chills; Cough; Dyspnoea; Dyspnoea; Electrocardiogram normal; Hot flush; Lymphocyte count decreased; Pain; Productive cough; Urine analysis normal; Wheezing; White blood cell count increased; Arthralgia; Back pain; Cough; Dyspnoea; Muscular weakness; Pyrexia; Spirometry abnormal	ANTH~EMERGENT BIOSOLUTIONS~FAV105~1~IM~LA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U2308AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB094AA~UNK~IM~RA~HEP A + HEP B (TWINRIX)~1|ANTH~UNKNOWN MANUFACTURER~~1~SC~~ANTHRAX (NO BRAND NAME)~2|FLUX~UNKNOWN MANUFACTURER~~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEPAB~UNKNOWN MANUFACTURER~~3~~~HEP A + HEP B (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0284483	06/18/2007		17.0			F	06/14/2007	This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female experienced injection site erythema, injection site warmth, skin ulcer and tenderness following vaccination with Gardasil. The patient experienced on the left deltoid site a 5 cm x 3  1/2 cm circular erythematous tender area that was warm to the touch, and a lesion that was very tender. No further information is available. The original reporting source was not provided. Additional information has been requested.									U	01/03/2007	01/03/2007	0	Unknown	OTH	OTH		Latex allergy			WAES0705USA04564	1						1	Injection site erythema; Injection site warmth; Skin lesion; Skin ulcer; Tenderness	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0961F~UNK~UN~UN~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0282271	06/19/2007	TX		19		F	06/11/2007	Swelling and tenderness to arm									Y	06/08/2007	06/08/2007	0		OTH	OTH	Sprinte C 28	none	Seaford allergies			1						1	Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2279AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0020U~2~~RA~HEP A (VAQTA)~1|MNQ~SANOFI PASTEUR~U1976AB~1~~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2610AA~1~~RA~TDAP (ADACEL)~1|TYP~SANOFI PASTEUR~Z0443~1~~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|VARCEL~MERCK & CO. INC.~1145F~2~~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0282286	06/19/2007	FL	38.0	38		F	06/18/2007	Patient STATES, 10 DAYS AFTER THE ADMINISTRATION OF THE VACCINES, SHE DEVELOPED TWO ERASER SIZE RED AREAS WHERE THE TDAP WAS INJECTED. THE AREA WHERE THE FLU VACCINE WAS GIVEN WAS BRUISED ONLY. THE VACCINES WERE INJECTED IN THE SAME ARM (PER REQUEST OF patient. THE TDAP SITE BEGAN TO INCREASE IN SIZE UP TO 1/2 INCH IN DIAMETER IN REDNESS. SHE STATES, THE SITE WAS NOT RAISED.  THE SKIN BEGAN TO DIE ON TOP. SHE THEN PEELED IT OFF AND IT BEGAN TO BLEED. SHE DENIES ANY ITCHING AND SHE DID NOT FEEL LIKE SHE DEVELOPED A FEVER. TWO WEEKS AFTER THE TDAP VACCINE WAS GIVEN, Patient STATES THE SITE IS STILL RED AND ABOUT THE SAME SIZE BUT IT IS STILL NOT RAISED. SHE CONTINUES TO DENY ANY ITCHING OR FEVER. SHE IS APPLYING ANTIBIOTIC OINTMENT TO THE TDAP VACCINE SITE.  THE FLU SHOT SITE HAS COMPLETELY DISAPPEARED.									Y	06/03/2007	06/13/2007	10	NONE, Patient DID NOT WANT TO SEE A PHYSICIAN OR GO TO THE CLINIC BECAUSE SHE FELT THE REACTION TO THE VACCINE DID NOT LOOK SEVERE ENOUGH TO HAVE IT SEEN BY A PHYSICIAN. SHE IS APPLYING ANTIBIOTIC OINTMENT TO THE SITE.	MIL	PUB	CORTISONE INJECTIONS 2/20, 3/16, AND 3/23, SOMA PRN, NAPROXEN 500MG PRN, AND CENTRUM DAILY, VIT C DAILY	Patient STATES SHE FELT PERFECTLY FINE. DENIES ANY COLDS, FEVERS AND PAIN.	LOWER LUMBAR SWELLING, DENIES ANY ALLERGIES TO ANY MEDICATIONS			1						1	Injection site bruising; Injection site erythema; Injection site haemorrhage	FLU3~SANOFI PASTEUR~U2286AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2730AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0282397	06/20/2007	DE	27.0	27		F	06/20/2007	27 y/o female develops a skin rash 2 days after the receipt of multiple vaccinations (AVA #1, Hep B, and Influenza IM). Pt is about to be deployed. SRC physician wants to known whether or not the SM should be exempted from further anthrax series. Symptom: Rash, diffuse Start: 02/17/2007 End: 03/19/2007 Comment: Rash started on the forearms but than rapidly spread to the torso, back, neck, and legs. Symptoms: Pruritis Start: 02/17/2007 End 03/19/2007 Comment: skin rash was initially pruritic. Pruritis slowly resolved with TAC creme than prednisone rx.				Y					Y	02/15/2007	02/17/2007	2	See summary	MIL	MIL	Oral Contraceptive pills	None	NKDA, No birth defects, Tinea Versicolor only.			1						1	Pruritus; Rash generalised	ANTH~UNKNOWN MANUFACTURER~~1~~~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~1~~~HEP A (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0282419	06/20/2007	NJ	62.0	81		F	06/20/2007	This case was reported by a consumer and described the occurrence of pneumonia in a 82-year-old female subject who was vaccinated with Flulaval for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medical conditions included arthritis. On 2 January 2007 the subject received primary course of Flulaval (.5 ml, unknown). Seven to ten days after vaccination with Flulaval, the subject experienced pneumonia. The consumer considered that the events were disabling and life-threatening. This case was assessed as medically serious by GSK. At the time of reporting the event was resolved.									Y	01/02/2007			UNK	OTH	OTH		ARTHRITIS	The reporter stated that her husband also experienced pneumonia after he received flulaval. She also knew of three other people that experienced pneumonia after receiving an the influenza vaccine (manufacturer unknown). GSK numbers A0658281A, A0658282A, A0658283A and A0658284A.		A0657643A	1						1	Pneumonia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0282421	06/20/2007	NJ	84.0	84		M	06/20/2007	This case was reported by a consumer and described the occurrence of pneumonia in a 84-year-old male subject who was vaccinated with Flulaval GlaxoSmithKline for prophylaxis. A physician or other health care professional has not verified this report. The reporter was the subject's wife. Concurrent medical conditions included arthritis and heart condition. Concurrent medications included Cardiovascular medication. On 2 January 2007 the subject received primary course of Flulaval (0.5 ml, unknown, unknown arm). Seven to ten days after vaccination with Flulaval, the subject experienced pneumonia. This case was assessed as medically serious by GSK. The reporter considered that the events were disabling and life-threatening. At the time of reporting the event was resolved.									Y	01/02/2007			UNK	OTH	OTH	Cardiovascular medication	ARTHRITIS, HEART CONDITION	The reporter stated that her husband also experienced pneumonia after he received Flulaval. She also knew of three other people that experienced pneumonia after receiving an the influenza vaccine (manufacturer unknown). GSK numbers A0658281A, A0658282A, A0658283A and A0658284A.		A0658281A	1						1	Pneumonia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0282422	06/20/2007	NJ				M	06/20/2007	This case was reported by a consumer and described the occurrence of pneumonia in an adult male subject who was vaccinated with influenza virus vaccine (unknown manufacturer) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Influenza virus vaccine (unknown). At an unspecified time after vaccination with Influenza virus vaccine, the subject experienced pneumonia. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.									U				UNK	OTH	OTH		Unknown	The reporter stated that her husband also experienced pneumonia after he received Flulaval. She also knew of three other people that experienced pneumonia after receiving an the influenza vaccine (manufacturer unknown). GSK numbers A0658281A, A0658282A, A0658283A and A0658284A.		A0658282A	1						1	Pneumonia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0282423	06/20/2007	NJ				M	06/20/2007	This case was reported by a consumer and described the occurrence of pneumonia in a male subject of unspecified age who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Influenza virus vaccine (unknown). At an unspecified time after vaccination with Influenza virus vaccine, the subject experienced pneumonia. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.									U				UNK	OTH	OTH		Unknown	The reporter stated that her husband also experienced pneumonia after he received flulaval. She also knew of three other people that experienced pneumonia after receiving an the influenza vaccine (manufacturer unknown). GSK numbers A0658281A, A0658282A, A0658283A and A0658284A.		A0658283A	1						1	Pneumonia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0282424	06/20/2007	NJ				F	06/20/2007	This case was reported by a consumer and described the occurrence of pneumonia in an adult female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Influenza virus vaccine (ml, unknown). At an unspecified time after vaccination with Influenza virus vaccine, the subject experienced pneumonia. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.									U				UNK	OTH	OTH		Unknown	The reporter stated that her husband also experienced pneumonia after he received Flulaval. She also knew of three other people that experienced pneumonia after receiving an the influenza vaccine (manufacturer unknown). GSK numbers A0658281A, A0658282A, A0658283A and A0658284A.		A0658284A	1						1	Pneumonia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0266889	06/22/2007		14.0			F	06/19/2007	Initial information received on 13 June 2007 from another manufacturer, report# WAES0705USA05099. The initial reporter to this manufacturer had been the FDA, VAERS# not provided. Verbatim from the report: Information has been received from a line listing obtained on request by the company from the FDA under the Freedom of Information Act concerning a 14 year old female with rhinitis allergic environmental allergy and eczema and a history of immunization reaction who on 25-OCT-2006 was vaccinated with Gardasil, IM thigh (lot 653978/0955F). Concomitant suspect immunizations included DTaP (unspecified) (IM thigh); Menactra (IM thigh), influenza virus vaccine (unspecified) (IM same thigh as Gardasil). The same day patient received allergenic extract (both arms). Additional concomitant medication included Nasocort and Zyrtec. The following day, on 26-OCT-2006 the patient was hospitalized with dehydration, hypersensitivity, muscle spasms and pyrexia (103F). Exam revealed injection site visible on extremities, no rash, erythema or exudate noted around the site. No other rashes. She was discharged the following day with diagnosis of allergic reaction. She also experienced pain and symptomatic problems 3 weeks prior following allergy injection. No further information is available.					Y	2			U	10/25/2006	10/26/2006	1	C-reactive protein 1.8, glucose 118, carbon dioxide 21	UNK	UNK	ALLERGENIC EXTRACT, NASOCORT, ZYRTEC	rhinitis allergic, environmental allergy, eczema	immunization reaction		200702171	1						2	Blood glucose increased; C-reactive protein normal; Carbon dioxide normal; Dehydration; Hypersensitivity; Muscle spasms; Pain; Pyrexia	DTIPV~UNKNOWN MANUFACTURER~~UNK~IM~~DT + IPV (NO BRAND NAME)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HPV4~MERCK & CO. INC.~0955F~1~IM~~HPV (GARDASIL)~2|MNQ~SANOFI PASTEUR~~UNK~IM~~MENINGOCOCCAL CONJUGATE (MENACTRA)~2	USA	Hospitalisation	Influenza
0282652	06/22/2007	LA	0.5	0	.5	F	06/21/2007	Information has been received from a physician concerning a 6-month-old female with no medical history or allergies who on 15-SEP-2006 (Lot #655082/0779F), 02-NOV-2006 (Lot #655174/0848F) and 08-JAN-2007 (Lot #655407/1115F) was vaccinated PO with the first, second and third doses, respectively, of ROTATEQ. Concomitant vaccinations administered on that same day included a dose of PREVNAR, a dose of PEDVAXHIB and a dose of PEDIARIX. The physician reported that two and a half weeks after receiving the third dose , on approximately 25-JAN-2007, the patient developed intussusception. Unspecified medical attention was sought and the patient was subsequently hospitalized. While hospitalized, the intussusception was corrected without surgery by a contrast procedure. The patient was hospitalized for an undetermined length of time and released on 15-MAR-2007. The patient was considered to be recovered. The physician also considered the intussusception to be an other important medical event due to the contrast procedure. Additional information has been requested.  6/25/07 Received vax record from pcp which confirmed RO dose & lot # as reported.  Also provided additional info on other vax received same date.  VAERS database updated w/same.  7/20/07 Received t/c from reporters office w/MRN & corrected dates of admission which was 3/15-3/17/07.  8/14/07 Received hospital medical records which reveal patient experienced nausea 7 vomiting x 5 days.  no stool x 4 days.  Seen by PCP who noted tarry stool & sent to ER.  Fever in ER.  Admitted 3/15-3/17/07.   FINAL DX: Intussusception, enema reduced; acute gastroenteritis.				Y	Y	3			Y	01/08/2007	03/10/2007	61	Unknown LABS: Abdominal x-ray & CT scan c/w IS. Air enema reduced IS. Blood c/s neg.	OTH	OTH			None PMH: otitis media 2 wks prior to admit.  RSV 3-4 mos prior to admit.		WAES0706USA01914	1						1	Intussusception	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B079BA~3~UN~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~AVENTIS PASTEUR~UT2M4LA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08620K~3~UN~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1115F~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0282671	06/22/2007	PR		51		U		Ache - joints and muscles - blood - pressure: high and high cholesterol - blood pressure varies - depression - headache: uncontrollable - problem with skin										12/18/2003			None	UNK	UNK						1						1	Arthralgia; Blood cholesterol increased; Blood pressure fluctuation; Depression; Headache; Hypertension; Myalgia; Skin disorder	ANTH~UNKNOWN MANUFACTURER~~UNK~~~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1	USA		Influenza
0282829	06/25/2007	CA	28.0	28		F	06/25/2007	Employee stated that her vaccinated arm was very sore for 2 weeks after vaccine was administered.									Y	10/26/2006	10/27/2006	1		PVT	PVT		none				1						1	Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71216~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0282830	06/25/2007	CA	35.0	35		F	06/25/2007	Patient felt very sick the evening the vaccine was given.  She felt dizzy,severe flu like symptoms.									U	10/30/2006	10/30/2006	0		UNK	UNK						1						1	Dizziness; Influenza like illness; Malaise	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71216~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268954	06/26/2007	TX	48.0	48		F	06/26/2007	This case was reported by a healthcare professional and described the occurrence of flushing in a 48-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis. Concurrent medical conditions included high blood pressure . Concurrent medications included unknown medication (Toporoal) and Benicar. On 27 October 2006 at 08:00 the subject received 1st dose of Fluarix in the left arm. On 27 October 2006, 90 minutes after vaccination with Fluarix, the subject experienced flushing, nausea and dizziness. Thirty minutes later, the subject experienced vomiting and hearing loss. The subject was unable to drive and activities of daily living became impaired. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). The subject was treated with unknown medications. At the time of reporting the events were unresolved.								Y	N	10/27/2006	10/27/2006	0	The subject has had an MRI, hearing and balance tests, blood tests and neurological testing. No results were provided.	OTH	OTH	Olmesartan medoxomil	High blood pressure	The subject has previously had flu shots and had no reaction. The subject has had no history of reaction to any vaccinations in the past.		A0660050A	1						2	Acoustic stimulation tests; Activities of daily living impaired; Blood test; Deafness; Dizziness; Flushing; Impaired driving ability; Nausea; Neurological examination; Nuclear magnetic resonance imaging; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA210AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Disabling	Influenza
0282866	06/26/2007	NY	50.0			M	06/21/2007	Patient developed nasal congestion within 5 minutes of receiving the influenza vaccine. Prior immunizations of flu vaccine had been well tolerated. Patient was treated in the emergency room with Benadryl, Solumedrol, Albuterol and Ranitidine. After treatment in the emergency room patient improved and was discharged home. Manufacturer: Sanofi Pasteur Lot # U2249AA Expiration date: 6/30/07 Symptoms: 1. Headache, 2. Anaphylaxis, 3. Hypertension (4) swelling, shortness of breath.										11/28/2006	11/28/2006	0		UNK	UNK						1						1	Anaphylactic reaction; Dyspnoea; Headache; Hypertension; Nasal congestion; Swelling	FLU3~SANOFI PASTEUR~U2249AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0282929	06/27/2007	MS	21.0	21		M	06/27/2007	Presented to the Medical Clinic on 6/25/07 with c/o general malaise, shortness of breath and redness to vaccination site. Urticaria wheals noted to upper left arm and some on right arm. Blister to upper left arm measured 2cm with thick exudate present. Given Ibuprofen, Claritin, and Z-pak.				Y					U	06/14/2007	06/14/2007	0	None	MIL	MIL	none	none	NKDA			1						1	Blister; Dyspnoea; Injection site erythema; Malaise; Urticaria	ANTH~EMERGENT BIOSOLUTIONS~unknown~3~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~unknown~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020076~1~ID~LA~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~Z06632~1~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0282935	06/27/2007	NC	68.0	68		F	06/27/2007	10/11/06 at 11:05AM, Influenza injection-Needle Stick - Distressing, Plunger Pressing - Very Distressing, Within the next 8 Hrs. Very Intense Pain from Shoulder to Finger Tips, Within the next 4 Hrs. Excruciating Pain from Shoulder to Finger Tips and could not lift left arm.10/12/06 at 3:00AM went to ER for evaluation and the Dr prescribed medication and advised me to see Orthopaedic Doctor ASAP for evaluation. 10/17/06 saw Dr. for evaluation, Shoulder X-ray and he prescribed medication. 10/31/06 saw Dr., MRI and he reported results to Dr. 11/27/06 saw Dr., Neurologist evaluation and prescribed medication and said he did not know what was wrong with my shouder, also Dr., EMG evaluation and reported to Dr. 02/07/07 saw Dr., Neurology Physical Thearpy for six weeks. 03/21/07 Dr., Pain Clinic Stellate Ganglion Injection. 04/25/07 Dr. said she could not help me and recommended that I see  Dr.,   Orthopaedic for Evaluation/Joint Injection he concluded that my Shoulder injury was caused by the influenza injection that I needed to see another Doctor to help me with this type of injury which was beyond his expertise. Curently, my pain level for the past three weeks has been excruciating and I have been unable to function independently. I need some medical help but I don't where to go now. Thank you				Y					N	10/11/2006	10/11/2006	0	X-rays, MRI, and EMG	UNK	UNK	Currently Lyrica and Ibuprofen	None	None			1						1	Activities of daily living impaired; Drug administration error; Electromyogram; Injected limb mobility decreased; Nuclear magnetic resonance imaging; Pain in extremity; X-ray	FLUX~UNKNOWN MANUFACTURER~U2186AA~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0282936	06/27/2007	CA	51.0	51		F	06/27/2007	Fluzone vaccine on 11/8/2006  Hepatitis A vaccine Havrix on 11/8/2006  Td vaccine on 11/8/2006  Vivotif (Live oral Typhoid) Started 11/15/06 and took one capsule every other day x four capsules.  Lariam generic (Mefloquine Hydrochloride) 250 mg. Started 12/21/06 and took one pill each week for a total of four weeks. Symptoms of dysphagia started about 1/1/2007 along with slurred speech(dysarthria), tongue twitch, and generalized weakness which have been present to varying degrees since 1/1/2007.  The other intermittent symptoms she has experienced over the course of the last six months are R occipital and parietal throbbing type pain, R ear pain, general headaches, R cheek droop once x 15 min, L facial numbness, balance/coordination difficulty, L arm numbness once x 15 min (like rubber band on it), tongue/cheek twitching, and a very, very mild L lower branch Bell's Palsy.  The symptoms are stable at this point in time. Currently the renaining symptoms are the dysphagia, tongue twitch, slurred speech and fatigue. She has been worked up from the ENT and Neurological perspective. Neuro initially thought neurologic paraneoplastic syndrome and then the ALS center gave her the diagnosis of amyotrophic lateral sclerosis (progressive bulbar palsy). She is being looked at now from the immunologic perspective since her symptoms seem temporally related to the vaccines and Lariam. Currently she is treating with a foriegn physician for paraneoplastic syndrome with reinfusion of her own Natural Killer cells, dendritic cells, phenylase and Rapakine plus some type of vaccine.She is also conferring with and being tested for immune dysregulation and possible mercury toxicity. Those results are not back yet. She has not been classified as permanently disabled as yet but her work has been affected. 7/5/07-records received for DOS 11/8/06-4/19/07-seen on 1/26/07- for C/O right ear pain times one week and slurred speech times 3-4 weeks. Symptoms consist of diplopia, slurred speech, numbness on left side of face, balance/coordination difficulty, swallowing difficulty, left lower facial weakness. Headaches localized in right occipital area, right parietal area. Recent travel to India. Patient had a cough and headache in India and returned feeling very weak. PMH: back apin, migraines and neck pain. Slightly elevated liver enzymes and elevated ESR could be thre tail end of viral illness acquired in India which is resolving. Seen on 4/2/07- C/O cough and cold. Dyspnea worse with moderate exertion. Neurology consult 4/13/07-Neuro exam demonstrated dysarthria accompanied by emotional lability, highly suggestive of bilateral corticobulbar tract lesion. Pseudobulbar palsy remains unexplained probably due to upper motor neuron degenerative disease. Seen by neurologist on 4/3/07-indicated that upon arrival in India on 12/26/06 family noticed her speech had changed. Two episodes of emotional upset that were accompanied by drooping left side of face. Laughs inappropriately during conversation with others. Fatigue, difficultly with swallowing. Seen on 4/18/07-Impression:unmistakable clinical features of bulbar amyotrophic lateral sclerosis (ALS).									N	11/08/2006	12/31/2006	53	Waiting on Immune Dysregulation panel results and all other tests and labs were within normal limits. records received 7/5/07- Labs for myasthenia gravis negative. CT angiogram of head, MRI MRA of brain. CXR normal. Ultrasound doppler of carotid artieries normal. Blood tests negative. MRI of head and spine normal. Awake EEG normal.	UNK	UNK	Lariam generic- Mefloquine Hydrochloride started 12/21/2006 and given once a week for four weeks for antimalaria prophylaxis before trip to India.	None	1997 had both DT and Hep A vaccines with no adverse reaction.Hx neck/back pain and migraines.			1						1	Amyotrophic lateral sclerosis; Asthenia; Balance disorder; Bulbar palsy; Coordination abnormal; Dysarthria; Dysphagia; Ear pain; Eye pain; Facial palsy; Fatigue; Headache; Hypoaesthesia facial; Immune system disorder; Laboratory test; Muscle twitching; Amyotrophic lateral sclerosis; Dysarthria; Dysphagia; Facial palsy; Fatigue; Headache; Vision blurred; Amyotrophic lateral sclerosis; Antibody test abnormal; Blood mercury abnormal; Blood test abnormal; Chelation therapy; Dysarthria; Dysphagia; Facial palsy; Fatigue; Headache; Hypoaesthesia; Hypoaesthesia facial; Immune system disorder; Metal poisoning; Tongue disorder	DT~MASS. PUB HLTH BIOL LAB~TD-162~UNK~IM~UN~DT ADSORBED (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U-2255AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB107AA~UNK~IM~UN~HEP A (HAVRIX)~1|FLU3~SANOFI PASTEUR~U2255AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB107AA~UNK~IM~~HEP A (HAVRIX)~2|TD~MASS. PUB HLTH BIOL LAB~TD162~UNK~IM~~TD ADSORBED (TDVAX)~2|TYP~BERNA BIOTECH, LTD.~~UNK~PO~MO~TYPHOID LIVE ORAL TY21A (VIVOTIF)~2|FLU3~SANOFI PASTEUR~U2255AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~3|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB107AA~UNK~IM~UN~HEP A (HAVRIX)~3|TD~MASS. PUB HLTH BIOL LAB~Td162~UNK~IM~UN~TD ADSORBED (TDVAX)~3	USA		Influenza
0283065	06/28/2007	GA	1.8	1	.8	M	03/16/2007	This is a 1-year-old female who was admitted with a history of fever, vomiting and rash. Physical examination on admission has shown irritable child. Patient was initially admitted and started on intravenous antibiotics for tonsillitis. However, in view of increasing serum bili and high transaminases, antibiotics were withdrawn. Antihistamines were given for treatment of rash. Patient was monitored carefully and was placed on low fat diet. She improved over the next 4-5 days and showed decrease in irritability. Icterus, rash disappeared and the tonsillar congestion resolved. She was discharged home and also showed progressive improvement of biochemical markers of liver involvement. Diagnoses: Acute tonsillitis. Hepatitis, possibly viral or drug induced, improving. 1/2/07. DC DX:Acute tonsilitis. Hepatitis viral or drug induced. C/O Fever, vomiting, rash and irritability.					Y	5			Y	12/19/2006	12/27/2006	8	Initial WBC 12,000, HGB 13.9, HCT 39.9, and Platelets 129. Differential was unremarkable. Initial CMP showed ALT and AST elevated to 450 and 374 respectively. Total bilirubin 1.1. Series of CBC and CMP were performed during the hospital stay, which showed mild elevation of bilirubin to a max of 3.9 with direct bili of 2.3. Upon discharge a total of 3 with direct of 2. ALT and AST show progressive decline and were 40 and 95 respectively upon discharge. Serum Albumin level was also reduced to 2.4 upon discharge. Blood culture showed no growth. Mono spot test was negative. Rapid Strep was negative. Chest was suggestive of opacity in the right lower lobe. Ultrasound of the abdomen was unremarkable for the liver, spleen, and kidneys.  WBC 12,000. ALT 450 AST 374. Total bili 3.9. Direct bili 2.3. Albumin elevated. Rapid stre and mono spot negative. Blood culture no growth. CXR opacity right lower lobe. US abdomen negative	PUB	PUB	None	None	None		GA07017	1						1	Acute tonsillitis; Alanine aminotransferase increased; Aspartate aminotransferase increased; Bilirubin conjugated increased; Bilirubin conjugated normal; Blood albumin decreased; Blood bilirubin abnormal; Blood bilirubin increased; Blood culture negative; Chest X-ray abnormal; Full blood count; Haematocrit decreased; Haemoglobin normal; Hepatitis; Irritability; Jaundice; Metabolic function test abnormal; Mononucleosis heterophile test negative; Platelet count decreased; Pyrexia; Rash; Streptococcal identification test; Streptococcal identification test negative; Ultrasound abdomen; Vomiting; White blood cell count increased	FLU3~SANOFI PASTEUR~U2191CA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB130AA~2~IM~RL~HEP A (HAVRIX)~1	USA	Hospitalisation	Influenza
0283069	06/28/2007	TX	51.0	50		M	06/28/2007	Client was given the influenza vaccine on 2/5/07 to left deltoid. 3-4 days after the shot, client experienced pain in arm and limited range of motion. Client never went to a doctor and only notified clinic who administered vaccine on 6-26-07. The nurse assessed the arm w/no signs of swelling, redness or infection. Pain has continued since approx. 2-8-07.									U	02/05/2007	02/08/2007	3		PUB	UNK		None	Unknown			1						1	Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2239AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0283128	06/28/2007	PA	12.0	12		M	06/27/2007	Varicella vaccine stored in freezer at 28 deg x 24 deg. Recommended to revaccinated or draw titer.										02/07/2007				PVT	PUB						1						1	Medication error	FLU3~SANOFI PASTEUR~0172U~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0427R~2~SC~~VARICELLA (VARIVAX)~1	USA		Influenza
0266787	06/29/2007	LA	65.0	65		F	06/15/2007	This case was reported by a lawyer and described the occurrence of Guillain Barre syndrome in a 65-year-old female subject who was vaccinated with influenza virus vaccine for prophylaxis. A physician or other health care professional has not verified this report. According to the vaccination record forwarded by the reporting attorney, on 17 October 2006 at 13:!5 the subject received unspecified dose of Fluarix (.5 ml, intramuscular, unknown deltoid). The attorney reported that the date of injury occurred on the same day as the subject's vaccination with Fluarix, 17 October 2006. On an unknown date, she developed Guillain Barre syndrome, and she was hospitalized on 03 November 2006. At the time of reporting the outcome of the events were was unspecified.					Y	0			U	10/17/2006	10/17/2006	0	UNK	OTH	OTH		Unknown	The subject denied a history of allergies to latex/natural rubber, eggs, and/or Thimerisol. She denied a history of fever in the 24 hours preceding vaccination with Fluarix, a history of Guilliain-Barre syndrome, neurological conditions, and/or a reaction in the past to a flu shot or Flumist. Concomitant medications and concurrent medical conditions were not reported.		A0649124A	1						2	Guillain-Barre syndrome	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA211BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Hospitalisation	Influenza
0275942	06/29/2007	CA	29.0	29		F	06/15/2007	This case was reported by a consumer and described the occurrence of injection site soreness in a 29-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline. A physician or other health care professional has not verified this report. On 25 September 2006 at 05:30 the subject received unspecified dose of Fluarix intramuscularly in the left arm. On 27 September 2006, 2 days after vaccination with Fluarix, the subject experienced injection site soreness and pain in arm on lifting. On 25 November 2006, the events were resolved.									Y	09/25/2006	09/27/2006	2	UNK	OTH	PVT		Unknown			A0647496A	1						2	Injection site pain; Pain in extremity; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA201AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA201AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~2	USA		Influenza
0275943	06/29/2007	CA	36.0	36		F	06/15/2007	This case was reported by a consumer and described the occurrence of dizziness in a 36-year-old female subject who was vaccinated with Fluarix (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included Oral contraceptive (Birth control pill). On 25 October 2006 at 09:30 the subject received unspecified dose of Fluarix in the left arm. One hour after vaccination with Fluarix, the subject experienced dizziness. Muscle cramping started in the evening of 26 October 2006 which lasted for 90 minutes and then occurred at a later time for 15 minutes. The subject also experienced heat at the injection site which was helped with analgesic. At the time of reporting the events were resolved.									Y	10/25/2006	10/25/2006	0	UNK	UNK	UNK	Oral contraceptives	Unknown	The subject is allergic to milk and chocolate (stomach cramping, lactose interolerance).		A0647498A	1						2	Dizziness; Muscle spasms; Dizziness; Injection site warmth; Muscle spasms	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA216AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA216AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~2	USA		Influenza
0284625	06/29/2007	WA	45.0	45		F	06/15/2007	This case was reported by a physician who was also the subject and described the occurrence of shoulder pain in an adult female subject who was vaccinated with Fluarix (GlaxoSmithKline) for prophylaxis.  There were no concurrent medications.  At the time of reporting, the subject was lactating.  On an unspecified date in the past, prior to 1 December 2006, the subject received an unspecified flu shot (unknown manufacturer) and experienced lack of effect (she developed the flu).  At the time of reporting, the outcome was unspecified.  On 1 December 2006, the subject received an unspecified dose of Fluarix (.5 ml, intraarticular).  The same day, after vaccination with Fluarix, the subject experienced shoulder pain and drug administered via inappropriate route.  The subject believed she received the Fluarix injection in her right shoulder (intraarticular), but was not certain.  She reported that she has had pain in her shoulder since receiving Fluarix on 1 December 2006, and that the pain has worsened over the last week.  At the time of reporting, she had not consulted another physician regarding the pain.  The physician considered the pain in her shoulder was possibly related to vaccination with Fluarix.  According to the Fluarix prescribing information, injections of Fluarix should be administered intramuscularly, preferably in the region of the deltoid muscle.  Follow-up information was received on 02 March 2007 via the subject, who is also a physician.  The subject was 45-years-old at the time of the event.  The subject had been receiving influenza injections (manufacturer unknown) on an annual basis since 1990, and reported that she had developed influenza on two occasions despite vaccination (lack of effect).  She had no prior history of shoulder pain or rotator cuff injury.  On 01 December 2006, the subject received Fluarix which was injected into the posterolateral right shoulder.  The reporter noted that the needle mark was at or only very slightly below joint line - not over the mid-deltoid as it should have been.  Immediately following injection, the subject developed shoulder pain which occurred daily but was not constant.  The pain worsened in the two weeks following vaccination.  She noted that the pain occurred especially with external rotation, abduction, and some internal rotation of the shoulder, or with the use of the rotator cuff muscles.  The subject did not treat pain with medication due to continuing lactation.  At the time of this report, the event was unresolved.  The physician noted that the event did not involve severe disability, but that it was unknown whether the event resulted in permanent disability.  In the physician's opinion, the events were related to administration of Fluarix.  The physician specifically noted that the events were due to erroneous administration, and stated The problem is not the product, but rather its incorrect administration.								Y	N	12/01/2006	12/01/2006	0	UNK	PVT	OTH	Domperidone; prenatal vitamins	LACTATION.  At the time of reporting, the subject was lactating.	Medical history negative for shoulder pain or rotator cuff injury.		A0639900A	1						1	Drug ineffective; Immediate post-injection reaction; Incorrect route of drug administration; Influenza; Musculoskeletal pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601311~7+~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Disabling	Influenza
0284626	06/29/2007	CA	62.0	62		F	06/15/2007	This case was reported by a pharmacist and described the occurrence of arm pain in a 62-year-old female who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. Concurrent medications included Ibandronate sodium (Boniva). On 7 November 2006 the subject received a dose of Fluarix at 0.5ml, intramuscularly in the left arm. The vaccination was given about three inches below her shoulder joint, just above her bicep. The subject described to the pharmacist that she felt as though the administration of Fluarix was deeper than any other vaccination for influenza that she has received in the past. Initially, in November 2006, the subject experienced only mild pain at the injection site, which improved. However, in December 2006, the patient reported that the pain in her left upper arm, in the proximity to  the injection site of Fluarix, began to worsen. The pain was described as severe and radiating down her entire arm and sharp on movement. The pain worsens over time. The subject reported that at times she feels a pins and needles sensation in her left arm radiating down her arm and into her hand. The pain reportedly keeps the subject up at night. The subject has not received any treatment for the events. At the time of reporting the events were unresolved and the relationship of the events to Fluarix was not known.									N	11/07/2006			An X-ray of the subject's upper arm was unremarkable.	PUB	PVT	Ibandronate sodium	Unknown	The subject had been taking Fosamax for several years prior to this report. The subject has been receiving influenza vaccines for about 10 years with no adverse events.		A0643962A	1						1	Injected limb mobility decreased; Injection site pain; Pain in extremity; Paraesthesia; X-ray	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA223AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0284627	06/29/2007	CA	32.0	32		F	06/15/2007	This case was reported by a consumer and described the occurrence of swelling injection site in a 32-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  A physician or other health care professional has not verified this report.  On 27 October 2006 at 10:00 the subject received unspecified dose of Fluarix intramuscularly in the left arm.  On 28 October 2006, 1 day after vaccination with Fluarix, the subject experienced swelling injection site and a heat sensation at injection site.  A few days later, the subject developed injection site pruritus.  The subject also reported some injection site pain.  She treated the symptoms at the site with Tylenol and a heating pad with improvement.  At the time of reporting the events were resolved.									Y	10/27/2006	10/28/2006	1	Unknown	PVT	PVT		Unknown			A0647499A	1						1	Injection site pain; Injection site pruritus; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA216AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0284628	06/29/2007		51.0			F	06/15/2007	This case was reported by a consumer and described the occurrence of neurological problem in a 51-year-old female subject who was vaccinated with Fluarix (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of Fluarix (unknown).  At an unspecified time after vaccination with Fluarix, the subject experienced an unspecified neurological problem.  At the time of reporting the outcome of the event was unspecified.									U				UNK	OTH	OTH	Concomitant medications were not reported.	Concurrent medical conditions were not reported.	The subject's medical history, concurrent medical conditions, and concomitant medications were not reported.		A0648027A	1						1	Nervous system disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0284629	06/29/2007		52.0			F	06/15/2007	This case was reported by a consumer, via Merck, and described the occurrence of shingles in a 52-year-old female subject who was vaccinated with Flu vaccine (manufacturer unspecified) for prophylaxis.  A physician or other health care professional has not verified this report.  Concurrent medications include Levoxyl, Singulair, Zoloft and Advair.  On an unspecified date the subject received an unspecified dose of Flu vaccine.  One week after vaccination with Flu vaccine, the subject experienced shingles.  The subject reported that she believes that the flu vaccine caused her shingles.  The subject sought medical attention and had an office visit.  At the time of reporting the outcome of the event was unspecified.				Y					U				UNK	OTH	OTH	Thyroxine sodium; montelukast sodium; sertraline hydrochloride; fluticasone+salmeterol	Unknown			A0650503A	1						1	Herpes zoster	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0283309	07/01/2007		59.0			F	07/01/2007	A  59-year-old Caucasian  woman, previously well, underwent  her first influenza vaccination on November, 11, 2005. She had a previous diagnosis of Systemic Lupus Eryhtematosus (SLE) when she was 42-year-old  with cutaneous and articular involvement treated by a short steroid cycle  eventually leading to a complete remission for the subsequent 14 years. By four weeks  following influenza vaccination, she developed a devastating SLE flare-up including pericarditis, hepatitis, nephritis, pancytopenia and auto-immune haemolytic anemia, coupled with a tremendous increase in autoimmune serology , successfully  cured  with steroids and azathioprine.More in details, she developed pain , redness , swelling and tenderness  on the site of injection, and complained  a worsening  history of  loss of appetite and profound weakness in the subsequent weeks. One month later  she felt  progressively worse and presented at the Hospital for chest pain, palpitation,  pressure, discomfort and shortness of breath . Supraventricular paroxysmal tachycardia was diagnosed (200 bpm)  and adenosine was infused intravenously, with the resolution of the symptoms.  During the following days her conditions deteriorated , with  a quite total loss of appetite . She went again at the Emergency Department ten days later complaining the same symptoms as before. A new episode of  supraventricular tachycardia was diagnosed ( 200 bpm)  and the patient was discharged following carotid sinus massage  on therapy with  oral flecainid. During the following two weeks, because of a continuous weight loss (exceeding 10 Kg over the last two months) due tot a total inappetence and even worsening weakness , she underwent a gastroscopy, which resulted normal, and specialty consultation leaded  to a suspicion of hematological malignancy, due to pancytopenia. The  patient was discharged with a diagnosis of pancytopenia, autoimmune haemolytic anemia,  pericarditis, hepatits and nephritis due to systemic SLE flare-up.  Steroid therapy  and subsequently  azathioprine eventually leaded to a complete clinical and laboratory remission  by three months.			Y						Y	11/11/2005	12/07/2005	26	At the first admission , one month after vaccination, ,laboratory studies disclosed  a white cell count of 3.7 x103/µL with  73% neutrophils 73%, hemoglobin  10.8 g/dL,  and platelets 122,000/µL.  When she went again at the Emergency Department ten days later complaining the same symptoms, white cell count was of 2.6 x103/µL , hemoglobin  10 g/dL, and platelets  97,000/µL. Some dayle, later pancytopenia was diagnosed :white cell count was  1.6 x103/µL  , hemoglobin  10 g/dL,  and platelets  67,000/µL, coupled with antinuclear antibody (ANA) titer  was 1:1280, anti-double-stranded DNA antibody  titer   >250 IU/mL ( the highest detectable value, with a  normal range <20 IU/mL) , anti-SS-A antibody positive > 100 IU/mL, anti-ribonucleoprotein  and anti-Smith negative, anti-SSB >20 IU/mL , complements C4  10 mg/dL (normal 1647 mg/dL), C3 25 mg/dL (normal 80200 mg/dL), LDH 1200  IU/mL, ferritin  4140 ng/ml, AST 230 IU/mL, ALT 400 IU/mL, gammaGT 300 IU/m, with  polyclonal hypergammaglobulins  (26%) . Anticardiolipin antibodies were negative,  as well as Lupus anticoagulant.  Urinalysis showed cloudy urine with protein 100 mg/dL, a white cell count of 1220 per high-power field (HPF), granular casts 12/HPF, and many erythrocytes, while serum creatinine was  0.9 mg/dL .Pericardial effusion was demonstrated  by ecography, while renal sonography  disclosed normal kidneys . The direct   Coombs' test was positive. The  patient was discharged with a diagnosis of pancytopenia, autoimmune haemolytic anemia,  pericarditis, hepatits and nephritis due to systemic SLE flare-up.  Steroid therapy  and subsequently  azathioprine eventually leaded to a complete clinical and laboratory remission  by three months.	PVT	PUB		NO mention of any illness	The patient's medical  history  was notable for a previous diagnosis of Systemic Lupus Eryhtematosus (SLE) when she was 42-year-old , due to the occurrence of fiver, depression, butterfly, arthralgia, myalgia. Following a skin biopsy, a diagnosis of cutaneous and articular SLE  was made, and  oral steroid therapy was started and gradually tapered until to stop over the following three years.  She had an uneventful history in the subsequent 14 years except for transient migratory arthralgia treated with NSAID. Two years before, due to the occurrence of mild hypertension, she performed haematological examination showing normal blood count, normal renal function and unremarkable urine sediment.			1						1	Alanine aminotransferase increased; Anaemia haemolytic autoimmune; Anorexia; Antinuclear antibody increased; Antinuclear antibody positive; Aspartate aminotransferase increased; Asthenia; Blood creatinine decreased; Blood creatinine normal; Blood lactate dehydrogenase increased; Cardiolipin antibody negative; Chest discomfort; Chest pain; Complement factor C3 decreased; Complement factor C4 decreased; Condition aggravated; Coombs direct test positive; DNA antibody positive; Dyspnoea; Gamma-glutamyltransferase increased; Haemoglobin decreased; Hepatitis; Injection site erythema; Injection site pain; Injection site swelling; Nephritis; Neutrophil count increased; Neutrophil count normal; Palpitations; Pancytopenia; Pericarditis; Platelet count decreased; Serum ferritin increased; Supraventricular tachycardia; Systemic lupus erythematosus; Ultrasound kidney normal; Urine analysis abnormal; Weight decreased; White blood cell count decreased; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~1~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0278155	07/02/2007		0.92	0	.6	M	06/29/2007	Information has been received from the FDA (VAERS # 278155) through the CDC concerning an 11-month-old male with no history/pre-existing conditions who on 13-DEC-2006 was vaccinated with a third dose of Rotateq (Lot # 655863/1034F). Concomitant therapy that day included a second dose of Fluzone (Lot # 42174RA). The second dose of Rotateq (Lot # 654665/1017F) and the first dose of Fluzone (Lot # KU2174KA) were given on an unknown date. On 15-APR-2007, 113 post vaccination, the patient experienced intussusception. Follow up information received from the FDA (VAERS # 278155) through the CDC indicated that on 16-APR-2007, the patient had acute vomiting and stomach pains. He was seen in the ER screaming with a fever and diarrhea. A paralytic ilius was questioned, and GI was consulted. They indicated biliuos emesis and concern for intussusception. Films and KUB were normal status post enema with good results. The patient recovered. Laboratory data included: WBC=11.45; hemaglobin=11.5; hematocrit=34.2; platelets=431; CRP=1.0; NA=138; potassium=4.4; chloride=99; CO2=18; glucose=91; BUN=10; creatinine=0.4; LFTs=normal. A standard lot check investigation was performed for Lot # 655863/1034F). All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigations was performed. The testing performed on the batch prior to release met all release specifications. The lot met requirements of the Center for Biologics Evaluation and Research and was released.  Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested. VAERS # 278155				Y					Y	12/13/2006	04/15/2007	123	KUB X-ray - normal s/p enema with good results, WBC count 11.45, hemoglobin 11.5, hematocrit 34.2, platelet count 431, serum C-reactive 1.0, serum sodium 138, serum potassium 4.4, serum chloride 99, total serum carbon 18, serum glucose 91, serum blood urea 10, serum creatinine 0.4, hepatic function tests - normal	OTH	OTH			None		WAES0706USA00722	1						2	Abdominal X-ray; Abdominal pain upper; Barium enema; Blood chloride; Blood creatinine; Blood glucose; Blood potassium; Blood urea; C-reactive protein increased; Carbon dioxide normal; Diarrhoea; Ileus paralytic; Intussusception; Laboratory test; Liver function test; Platelet count; Pyrexia; Screaming; Vomiting; White blood cell count; Abdominal pain upper; Blood chloride normal; Blood creatinine normal; Blood glucose abnormal; Blood potassium normal; Blood sodium normal; Blood urea normal; C-reactive protein normal; Diarrhoea; Enema administration; Haematocrit normal; Haemoglobin increased; Ileus paralytic; Inappropriate schedule of drug administration; Intussusception; Liver function test normal; Platelet count increased; Pyrexia; Screaming; Urinary system X-ray; Vomiting; White blood cell count increased	FLU3~SANOFI PASTEUR~42174RA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|RV5~MERCK & CO. INC.~1034F~3~PO~MO~ROTAVIRUS (ROTATEQ)~1|FLU3~SANOFI PASTEUR~42174RA~2~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|RV5~MERCK & CO. INC.~1034F~3~UN~UN~ROTAVIRUS (ROTATEQ)~2	USA	Emergency room visit	Influenza
0283684	07/03/2007	CA		62		F	07/03/2007	C/O arm pain 1-2 days after vaccines given. C/O generalized muscle soreness, fevers on and off and exhaustion. Unable to pursue activities (walking and swimming) due to fatigue. Arm pain resolved. Other sxs persist.									U	06/19/2007	06/20/2007	1		PVT	UNK			GERD, HTN, Depression			1						1	Fatigue; Myalgia; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U2167MA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0324~UNK~~LA~POLIO VIRUS, INACT. (IPOL)~1|TDAP~SANOFI PASTEUR~C2690ZAA~1~~LA~TDAP (ADACEL)~1	USA		Influenza
0283823	07/05/2007	MA	2.0	2	.5	F	07/03/2007	Information has been received from a licensed practical nurse (LPN), concerning a 30 month old female child, who on 17-NOV-1997 was vaccinated with a dose of Pneumovax 23 (Lot #620350/0993E). Concomitant therapy included influenza virus vaccine (manufacturer unspecified). The nurse reported that subsequently (duration onset not specified), the child became paralyzed and could not walk, and also had a fever (temperature not Specified). the nurse stated the patient recovered from the events in one week. The patient sought unspecified medical attention. Upon internal review, the event of became paralyzed and could not walk, was considered to be an serious as an other significant medical event. Additional information has been requested.				Y					Y	11/17/1997			Unknown	OTH	OTH			Unknown		WAES0706USA05078	1						1	Abasia; Paralysis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0993E~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0284022	07/06/2007	WI	26.0	26		M	07/06/2007	Pt presented to the ER on 6/21/07 with c/o weakness, HA, rights sided pain and elevated temperature. Temp at time of visit 103. Admitted to the hospital for IV fluids and evaluation. Admitting diagnoses included febrile illness, probable viral, possible heat syndrome and possible small pox reaction. D/c'd on 6/26/07 from hospital with diagnoses of pneumonia.  07/17/2007 MR received for 3 night admit for initial c/o generalized weakness, malaise and sore throat. One episode of vomiting and R sided abd pain, fever, chills, SOB as well.  Pt developed hemoptysis during hospitalization.  DX: Right middle lobe pneumonia					Y	4			Y	06/13/2007	06/20/2007	7	WBC 8,000, BMP normal, HGB 15.5, Strept screen negative, Urine dip negative.  Labs and Diagnsotics: CXR showed RML pneumonia. Blood cultures (-). WBCs normal.  Other labs unremarkable.	MIL	MIL	None	None	NKDA. PMH: appendectomy.  NKDA.			1						1	Asthenia; Body temperature increased; Culture urine negative; Haemoglobin normal; Headache; Metabolic function test normal; Pain; Pneumonia; Streptococcal identification test negative; Viral infection; White blood cell count normal	ANTH~EMERGENT BIOSOLUTIONS~unknown~1~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~unknown~1~ID~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020076~1~ID~LA~SMALLPOX (DRYVAX)~1	USA	Hospitalisation	Influenza
0282936	07/09/2007	CA	51.0	51		F	07/03/2007	A case was received from a health professional on 28 June 2007 under the reference number VAERS E16538. SAE term: Amyotrophic lateral sclerosis. A 51-year-old female patient with a medical history of codeine and milk allergies had received an intramuscular injection of Fluzone (lot number U2255AA), Havrix (lot number AHAVB107AA), and Diptheria/Tetanus (lot number TD-162) on 08 November 2006. On 15 November 2006 she initiated oral Vivotif (lot not provided) once daily for four days, and oral Mefloquine (lot N provided) once daily for four weeks. On 28 December 2006 the patient traveled out of the country, and on 31 December 2006 she developed difficulty swallowing, slurred speech, and generalized fatigue. In January 2007 she experienced headaches, blurred vision, and right cheek droop lasting 15 minutes. She was hospitalized in January 2007 and April 2007 for testing, and was diagnosed with amyotrophic lateral sclerosis. Spinal tap, MRI, EEG, and CT scan were all within normal limits. Concomitant medications included vitamins and calcium, and the patient was not ill at the time of vaccination. According to the reporter, the difficulty swallowing, slurred speech, and generalized fatigue remained ongoing.					Y				N	11/08/2006	12/31/2006	53		UNK	UNK	Vitamins, Calcium		Allergic to codeine and milk.		200702371	1						2	Amyotrophic lateral sclerosis; Asthenia; Balance disorder; Bulbar palsy; Coordination abnormal; Dysarthria; Dysphagia; Ear pain; Eye pain; Facial palsy; Fatigue; Headache; Hypoaesthesia facial; Immune system disorder; Laboratory test; Muscle twitching; Amyotrophic lateral sclerosis; Dysarthria; Dysphagia; Facial palsy; Fatigue; Headache; Vision blurred; Amyotrophic lateral sclerosis; Antibody test abnormal; Blood mercury abnormal; Blood test abnormal; Chelation therapy; Dysarthria; Dysphagia; Facial palsy; Fatigue; Headache; Hypoaesthesia; Hypoaesthesia facial; Immune system disorder; Metal poisoning; Tongue disorder	DT~MASS. PUB HLTH BIOL LAB~TD-162~UNK~IM~UN~DT ADSORBED (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U-2255AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB107AA~UNK~IM~UN~HEP A (HAVRIX)~1|FLU3~SANOFI PASTEUR~U2255AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB107AA~UNK~IM~~HEP A (HAVRIX)~2|TD~MASS. PUB HLTH BIOL LAB~TD162~UNK~IM~~TD ADSORBED (TDVAX)~2|TYP~BERNA BIOTECH, LTD.~~UNK~PO~MO~TYPHOID LIVE ORAL TY21A (VIVOTIF)~2|FLU3~SANOFI PASTEUR~U2255AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~3|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB107AA~UNK~IM~UN~HEP A (HAVRIX)~3|TD~MASS. PUB HLTH BIOL LAB~Td162~UNK~IM~UN~TD ADSORBED (TDVAX)~3	USA	Hospitalisation	Influenza
0284078	07/09/2007	TX	33.0	33		F	07/05/2007	SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received from a physician on 12 October 2006. A 33 year old female patient received on 25 September 2006, intra-muscular, 0.5 ml booster of Adacel (lot number C2559AA, expiry date 12 August 2008), while she was 1 week pregnant (LMP was 10 June 2007). The patient did not receive any concomitant vaccines. The patient's past obstetric history included one previous pregnancy and subsequent full term delivery with a normal outcome. At the time of the report (12 October 2006), the patient did not have prenatal testing yet. No information about prior exposures to Adacel was provided. The patient did not experience any adverse reactions following receipt of Adacel on 25 September 2006. Follow-up information received on 11 May 2007. The patient received Adacel in the left deltoid and she did not have any illness at that time. The patient's past obstetric history included one previous pregnancy and subsequent full term delivery with a normal outcome in 2004. The patient's last menstrual period was 04 September 2006 and her expected date of delivery is 11 June 2007. The patient was last seen on 06 October 2006 for confirmation of pregnancy and was lost to follow-up by the reporting physician. She was referred to an OB/GYN for prenatal care. The reporting physician was not aware of the current pregnancy outcome. Follow-up information received on 02 July 2007 from a health care professional, Date of last menstrual periods was 11 September 2006. The estimated date of delivery was 11 June 2007. Past obstetric history included: 1 live birth, previous pregnancy with no pre-term / congenital anomalies. The patient received one intramuscular dose of Fluzone (lot# U2201AA) on 30 October 2006. Prenatal testing included serologies on 25 October 2006, which was normal and ultrasound on 03 November 2006, which showed no fetal cardiac activity. Outcome of the pregnancy was missed abortion on the first trimester with Dilation and curettage (D&C).				Y						09/25/2006			prenatal testing: serologies done on 25-Oct-2006 - normal: ultrasound 03-Nov-2006 - showed no fetal cardiac activity.	PVT	PVT	PRENATAL		Past obstetric history included one previous pregnancy and subsequent full term delivery with a normal outcome. Follow-up information received on 11 May 2007. She did not have any illness at the time of the vaccination. Her previous pregnancy occurred in 2004.		200602672	1						1	Abortion missed; Drug exposure during pregnancy; Foetal heart rate abnormal; Serology normal; Ultrasound scan abnormal	FLU3~SANOFI PASTEUR~U2201AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2559AA~1~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0284098	07/09/2007	MN	66.0	66		F	07/06/2007	Initial and follow-up information has been received from a registered nurse and a physician concerning a 66 year old female with penicillin allergy and allergies to LIPITOR, PRAVACOL, TRILEPTAL, and a history of hives with niacin and no illness at the time of vaccination who on 15-FEB-2007 was vaccinated intramuscularly in the right deltoid with a 0.5 ml first dose of Pneumovax 230(lot 655152/0889F). The patient was concomitantly vaccinated with a second dose of Fluzone (lot U2202AA). Concomitant therapy included ACIPHEX, aspirin, vitamin B (unspecified), vitamin B complex, ubidecarenone, CRESTOR, omega-3 marine triglycerides, glucosamine, LAMICTAL, NEXIUM and ezetimibe. On 15-FEB-2007, in the evening, the patient had extreme pain in the arm in which Pneumovax 23 was administered. The entire area from the right elbow to the shoulder/ upper arm was in pain. The patient had difficulty moving the right arm. The injection site was fine. The patient received the flu vaccine in the left arm which was not painful. The patient was still having pain the week following the vaccination. The patient was seen at an urgent care center. An x-ray done of right shoulder was normal. The patient was treated with PERCOCET, NAPROSYN, and ibuprofen and ice. The patient then switched therapy from PERCOCET to  VICODIN. The patient saw her primary care physician on 21-FEB-2007 with ongoing shoulder pain. The patient was referred to sports and orthopedic medicine. The outcome was unknown. The patient's right shoulder pain was considered an other important medical event. No additional information is expected.				Y					U	02/15/2007	02/15/2007	0	x-ray 02/??/07 - normal	PUB	OTH	Aspirin, NEXIUM, ZETIA, glucosamine, LAMICTAL, omega-3 marine triglycerides, ACIPHEX, CRESTOR, ubidecarenone, vitamin B (unspecified), vitamin b complex	Penicillin allergy; Drug hypersensitivity	Hives		WAES0702USA04728	1						1	Injected limb mobility decreased; Injection site pain; Musculoskeletal pain; Pain in extremity; X-ray normal	FLU3~SANOFI PASTEUR~U2202AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0889F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0284272	07/10/2007	MN	11.0	11		F		MEDI-0005846 is a serious spontaneous case from a physician involving cardiomegaly concerning a twelve-year-old female patient. No concomitant medications have been reported for this patient. The patient received FluMist in Oct/Nov 2006. Over past seven months, the patient developed dysphagia, acute fatigue, and cough which progressively worsened. The patient was diagnosed in the past week with cardiomegaly by x-ray with a ten percent ejection fraction. No outcome for the events was provided by the reporter. The reporter provided no causality assessment for the events. Per 60 day follow up: Three follow-up attempts made. No response from the reporter received. No additional information expected from the reporter. 07-MAR-08									U	10/01/2006	06/01/2007	243	X-Ray Cardiomegaly with 10% EF	OTH	OTH	Concomitant drugs not reported.				MEDI0005846	1						1	Cardiomegaly; Cough; Dysphagia; Ejection fraction decreased; Fatigue; X-ray abnormal	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0284328	07/11/2007	DE	48.0	48		F	01/09/2007	Day after injection site is bright red with knot and hot - area is about 2 x 3 inches (Tetanus) aches in arm and neck.				Y					Y	01/06/2007	01/07/2007	1		MIL	UNK	Over the counter cold medicine	COLD	None			1						1	Injection site erythema; Injection site mass; Injection site warmth	FLU3~SANOFI PASTEUR~U2308AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U1676AA~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0284330	07/11/2007	OH	14.0	14		F	06/30/2007	Fever - 12/29/06, bruising at the injection site 12/30/06, swelling approximately golf size at the injection site - 12/30/06.									Y	12/29/2006	12/29/2006	0		PVT	PVT	None	None	None			1						1	Injection site bruising; Injection site swelling; Pyrexia	FLU3~SANOFI PASTEUR~U2312AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1008F~UNK~IM~LA~HEP A (VAQTA)~1|HPV4~MERCK & CO. INC.~1425F~UNK~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0284397	07/12/2007	OK	16.0	16		M	07/01/2007	Our multihandicapped son was given the flu mist vaccine the first week of November, 2006. Child had known common variable IGa immunodeficiency diagnosis, which we learned months later was contraindicated for him. We were not informed by either our primary physician or immunologist that the vaccine contained a live virus. We had questioned the physicians concerning the mercury content of the flu injections he had received in prior years. Several days after receiving the vaccine, our son developed a sinus infection, followed by a psoiatic arthritis flare-up, & a trip to the E.R. for extreme abdominal pain, which we thought to be an appendicitis attack. At that time, the E.R. physicians felt our son had irritable bowel syndrome, and treated him with the medication Levain. Bloodwork on that admission indicated platelets were low, which alarmed our immunologist. We followed up with a visit to a hematologist who did more extensive bloodwork and wanted our son's abdomen, pelvis, and kidneys scanned with an upcoming CT scan to check his organ placement post Pectus Excavatum surgery. In December, our son developed pneumonia, which took three rounds of antibiotics, onionpoutices, and round-the-clock suctioning to heal. At the same time, he was also in severe abdominal pain with constant colon spasms which required 24 hour care by his parents. We were up all night and day with our son for three straight weeks, and made continuous strips to doctors' offices, the E.R. again, with more bloodwork, X-rays, and whatever tests deemed necessary. In February, our cardiologist ordered the Catt scan once he recovered from the pneumonia, under general anesthesia - Fentanyl- to prevent any adverse response to the contrast media, as our son is allergic to 17 different meds etc. We were hospitalized overnight for a colonoscopy and esophageal endoscopy to be performed the next day. Our son's colon was full and had not been emptying completely for months, despite a regime of Glocolax given daily. The most important info we obtained from the tests was from the scan, which showed a 5 cm. area of inflammation and Intussusception of the jejunem in the small intestine. His pain continued, and elimination was difficult, this time using Go-lytely daily. We requested an ultrasound be done in early March, which once showed the Intussusception occurring. The gastroenterologist brought the pediatric surgeon in at our request, and we agreed to go forward with exploratory bowel surgery. We also asked the surgeon to remove our son's appendix while he was in there, to prevent a future surgery for him, which he agreed to do. There was no bowel resection performed other than the appendectomy, which indicated lymphatic hyperplasia. Our son was hospitalized for 5 days post surgery, and had no post operative infection, which was not the case for his 2 previous surgeries in 2004 and 2005. Our son is to this day, still having constipation and discomfort eliminating. We are working with a new D.O, using whatever natural means we can to help alleviate this ongoing problem.10/22/07-records received for DOS 1/1107 and 3/21/07-admitted for intussusception. DX: Intermittent Intussusception. Exploratory laparotomy and appendectomy, findings: normal bowel. 1/11/2010 Patient still has an ongoing difficult bowel probkem-under continuing med care following his bowel surgery for intussusception-performed 3/20/07. 02/02/2010 We are still working through his elimination-not going regularly-bowel movements at times must be aided with suppositories, etc. Some daye cannot go and has discomfort when he skips a day or two.			Y		Y	4		Y	N	11/01/2006	11/07/2006	6	Description of lab work and tests included in summary above.	UNK	UNK	None		Down Syndrome Autism Tricuspid Valve Regurgitation/Pulmonary Atresia at birth Sleep Disorder Autonomic Nervous System Disorder Gluten Intolerance Reflux at times Increased Hemaglobin and Hct frequently Pericardial Effusion and Pulmonary Hypertension - Pericardial taps and Pericardiectomy done to alleviate. Delivery: 33 1/2 weeks - 5lb., 15 oz. 10/22/07-records received-PMH: Down's Syndrome, previous pericardiectomy for chronic pericardial effusion, chest pain.-			1						1	Abdominal pain; Appendicectomy; Appendix disorder; Blood test abnormal; Colonoscopy; Computerised tomogram; Constipation; Contraindication to vaccination; Endoscopy; Hyperplasia; Inflammation; Intussusception; Intussusception; Irritable bowel syndrome; Laboratory test; Laparotomy; Lymphoid tissue hyperplasia; Platelet count decreased; Pneumonia; Psoriatic arthropathy; Selective IgA immunodeficiency; Sinusitis; Abdominal pain; Appendicectomy; Arteritis; Arthritis; Blood test; Colonoscopy; Computerised tomogram; Constipation; Endoscopy; Intussusception; Irritable bowel syndrome; Platelet count decreased; Pneumonia; Sinusitis; Surgery; Ultrasound abdomen; X-ray	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0284687	07/13/2007	NY	1.05	1	.0	F	07/06/2007	Information has been received from a registered nurse concerning a 24 month old female, with no pertinent medical history, drug reactions or allergies, who on 18-MAY-2006 was vaccinated subcutaneously with 0.5 ml dose of MMRV (Lot # 653203/1138R). There was no concomitant medication. Ten months post vaccination with MMR, in approximately MAR2007, the patient developed a widespread outbreak of chickenpox. The patient was examined on 16 MAR 2007, and was found to have widespread vesicular lesions on bilateral hands, bilateral legs and the trunk. The patient was afebrile. A follow up exam is scheduled for 30 MAR 2007. No lab diagnostic studies were performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.  01/04/08 This is in follow-up to report(s) previously submitted on 7/6/2007. Information has been received from a registered nurse concerning a 22 month old female with no medical history or pre existing allergies who on 18-MAY-2006 was vaccinated subcutaneously into the right arm with a first dose of PROQUAD (Oka/Merck upgrade process) (Lot # 653203/1138R). Concomitant vaccine therapy that same day included a second dose intramuscularly, into the left leg of FLUZONE (Lot #U1788BA), a fourth dose intramuscularly into the right leg with ACTHIB (Lot # UE778AA) and a third dose, intramuscularly into the left leg of PREVNAR (Lot # B0863AF). There was no illness at the time of vaccination. On 16-MAR-2007 the patient presented at the walk in clinic with blister like lesions on the hands, legs, and trunk, and was subsequently diagnosed with varicella. The patient was afebrile. On 30-MAR-2007 the patient presented for a follow up doctor visit with scattered papular lesions on the legs, thighs, belly, and arms with scratch marks. The doctor's impression at that time was scabies. Treatment was permethrin cream. On 07 APR 2007 the patient presented to the walk in clinic with a complaint of a rash, which was diagnosed as allergic dermatitis. On 12 Mary 2007 the patient presented to a dermatologist, with erythematous papules on the right arm and right leg with excoriation. It was the impression of the physician that the patient had probable insect bites. A topical cream (unspecified) was prescribed, along with diphenhydramine hydrochloride elixir for pruritus, as well as calamine lotion. On 13 JUL 2007 a well child visit was conducted, at which time it was reported that the child was recovered. No lab diagnostic studies were performed. There was no product quality complaint. There were no adverse events reported with prior vaccinations: ACTHIB 30-Jun-2005, 16-Aug-2005, 05-Oct-2005, and PREVNAR 30-Jun-2005, 16-Aug-2005, 05-Oct-2005 and FLUZONE 15-Feb-2006.				Y					Y	05/18/2006	03/16/2007	302	None	PUB	PUB	Unknown		None		WAES0703USA04549	1						1	Arthropod bite; Blister; Blister; Convulsion; Excoriation; No reaction on previous exposure to drug; Rash erythematous; Rash vesicular; Varicella; Varicella	FLU3~SANOFI PASTEUR~U1788BA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE778AA~4~IM~RL~HIB (ACTHIB)~1|MMRV~MERCK & CO. INC.~1138R~1~SC~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B0863AF~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0284718	07/16/2007	PR	29.0	29		M		blood - high cholesterol, numbness and tingling: in arms, depression - deep problems, energy: loss, pain (muscle and joints), pain (lower back), blood pressure: varies, fibromyalgia, etc  5/27/08 Reviewed VA medical records of 10/2004-05/2008. Records reveal patient experienced: hyperlipidemia, right arm & neck pain w/radiculopathy, low back pain (since 2003)w/radiculopathy, left shoulder dislocation while on active duty overseas 11/2003-7/2004. insomnia, obesity, recurrent tonsillitis & URI, GERD, depression, DJD, bilateral CTS, DDD, adjustment disorder w/mixed anxiety & depressed mood, hand fracture from fall, recurrent left shoulder subluxation, capsulloraphy w/adhesive capsulitis of left shoulder, HTN, HA, eye floaters, bilateral sacroilitis w/steroid injections, sciatica, trochanteric bursitis, right dequervain tenosynovitis, right epicondylitis.  1/11/2010 Arthritis, major depression, high blood pressure, high blood cholesterol, energy low levels, Myalagia mood; anxious, irritable, libido: loss, flu-like symptoms, sleep problems, weight gain, neck, rigid pain, legs, lower back, muscles and joint, back, right thumb radiating up through forearm, tens needed for pain, numbness and tingling fingers, leg, memory: trouble remembering recent information.			Y	Y				Y	N	11/07/2003			See veterans records  LABS: high cholesterol.  EKG w/bradycardia & RBBB.  EMG/NCS RLE WNL.  Left shoulder anterior & posterior labral tear.	MIL	MIL		None	None  Allergic zocor. Family Hx: hyperlipidemia, diabetes.			1						1	Arthralgia; Asthenia; Asthenia; Back pain; Hypoaesthesia; Myalgia; Paraesthesia	ANTH~UNKNOWN MANUFACTURER~~UNK~~~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~UNKNOWN MANUFACTURER~~UNK~~~SMALLPOX (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Life Threatening,Disabling	Influenza
0284981	07/18/2007	MD	36.0	36		F	01/15/2007	A 36 year old, female patient (with a medical history of no known allergies, asthma, eczema, arrhythmias) developed swelling both hands, redness-especially on palms and complained of severe itching of her hands, approximately 12 hours after she received YF-Vax (lot number UE944AA, route of administration not reported) in the left upper arm and Influenza vaccine (manufactured by GSK; lot number 2F600911, route and site of administration not reported) on 28 November 2006. She was seen by a doctor and treated with antihistamines. At the time of the report, it was unknown if the patient recovered. Follow-up information received on 12 January 2007 from a health care professional. It was reported that the YF-Vax was administered subcutaneously in the left arm. The influenza vaccine was administered intramuscularly in the left arm. The patient had previously received an initial dose of influenza vaccine five years previously. As per the reporter, the exact duration of the events was three days. The patient subsequently experienced peeling of the skin from both of her hands 48 hours after the other symptoms in her hand subsided. The peeling of her skin lasted approximately two weeks. The patient was fully recovered from the events at the time of this report. Additional information is not anticipated.				Y					Y	11/28/2006	11/29/2006	1		PVT	PUB	Birth control		NKA, Asthma, eczema, arrhythmias. The patient previously received a first dose of influenza vaccine five years previously.		200603283	1						1	Erythema; Oedema peripheral; Pruritus; Skin exfoliation	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F600911~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|YF~SANOFI PASTEUR~UE944A~1~SC~LA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0285009	07/18/2007	VA	48.0	48		F	07/18/2007	RHEUMATOID ARTHRITIS - COURSE AS FOLLOWS:  Immediate localized tenderness at injection site.  Muscle pain within two weeks, attributed to injection and dismissed as minor by phone consultation w nurse.  Bilaterial Carpel Tunnel Syndrome one month post injection - diagnosed during office visit.  Tennis Elbow in left arm one month post injection - diagnosed during office visit.  Rheumatoid arthritis flare 4 months post injection - diagnosed via blood test taken during emergency visit to doctor's office.  Ongoing RA symptoms to current date, including one additional RA flare requiring ER visit.  Current medication treatment:  mevachor, relafen, norco, flexeril, calcium supplement, multivitamin,  folic acid.				Y					N	10/15/2006	10/15/2006	0	unknown to patient	PVT	PVT	prevachol, prinivil, enteric aspirin	None	Type II Diabetes			1						1	Carpal tunnel syndrome; Condition aggravated; Epicondylitis; Injection site pain; Myalgia; Rheumatoid arthritis	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0285159	07/19/2007	PR	24.0	24		M	06/21/2007	Severe body pain and joint, severe acne, spot of skin, rash, migraine, changes of behavior, severe back pain, etc.  7/31/07 Received medical records from VAMC for 9/04-7/07 which reveal patient experienced chronic neck & LBP s/p fall in 2004, hallux valgus deformity & severe pes planus deformity & arthritis of bilat feet, acne, hypertriglyceridemia, headaches w/photophobia, myositis, left knee pain   Tx w/PT for neck & back pain.  8/3/07 Received vax record from patient.  Does not include lot #s. VAERS database updated w/same.			Y					Y		11/06/2003			LABS: MRI of brain 1/05 revealed probable tortuous vessel of right MCA bifurcation & paranasal mucous retention cyst right maxillary sinus, eye refractive error.  Hearing test 5/05 was WNL. C-spine x-ray 12/04 revealed paravertebral muscle spasm & DJD.	MIL	MIL						1						1	Abnormal behaviour; Acne; Migraine; Pain; Rash; Skin discolouration	ANTH~UNKNOWN MANUFACTURER~~UNK~~~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~402007~UNK~~~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Life Threatening,Disabling	Influenza
0285200	07/19/2007	AZ	25.0			F	07/06/2007	Rash with itching on both arms below the shoulder above the elbows.									N				None	MIL	MIL	PPD Sanofi Pasteur Lot #LC2317AA; Zoloft *x 4 years)	No	Augmentin			1						1	Rash pruritic	FLU3~SANOFI PASTEUR~U2308AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHAABB080AB~UNK~UN~UN~HEP A + HEP B (TWINRIX)~1|TDAP~SANOFI PASTEUR~C2731AA~UNK~UN~UN~TDAP (ADACEL)~1	USA		Influenza
0285266	07/19/2007	MA	0.33	0	.3	F	07/19/2007	Legs swollen where injection administered, raised red lump about an inch long and half a centimeter high.  Madison was acting fussy and cranky, like she wasn't feeling well and in slight discomfort.  We gave her baby Tylenol a couple times.									Y	07/11/2007	07/11/2007	0		PVT	UNK		none	none			1						1	Discomfort; Injection site erythema; Injection site swelling; Irritability; Malaise	DPP~UNKNOWN MANUFACTURER~~UNK~~~DIPHTHERIA TOXOID + PERTUSSIS + IPV (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|OPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, ORAL (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1|RVX~UNKNOWN MANUFACTURER~~UNK~~~ROTAVIRUS (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~UNK~~~VARICELLA (NO BRAND NAME)~1	USA		Influenza
0285330	07/20/2007	CA	55.0	55		M	07/16/2007	immediate lesions at opening of each nostril, within one week severe head and chest congestion, within 6 weeks - near total loss of smell									N	11/21/2006	11/22/2006	1	Two office visits to ENT specialist	OTH	PVT	ATENOLOL - 50 MG; LOVASTATIN - 20MG	None	Allergies - compaigne and inovar - blood pressure and cholesterol			1						1	Anosmia; Nasal congestion; Skin lesion; Wrong drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500436P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0285492	07/23/2007	TX	0.6	0	.6	F	07/20/2007	Information has been received from a office manager in a physician's office concerning a 10 month old female, with no allergies, no history of surgery, no prior history of intussusception, congenital malformation of the intestine, or cystic fibrosis, who was vaccinated with a first, second, and third dose of ROTATEQ on 18-JAN-2007 (Lot# 653980/0285F), 15-FEB-2007 (Lot# 654489/0941F), and 15-MAR-2007 (Lot# 655405/1113F), respectively. It was reported that the office received an operative report stating that the patient was admitted to the hospital on 10-JUN-2007 after a visit to the emergency room. She had an exploratory lapartomy with reduction of intussusception and appendectomy on 10-JUN-2007. The diagnosis was unreducable intussusception. It was noted that the patient's family had not reported any signs or symptoms prior to the emergency room visit. The patient had not been back to the office for a follow-up. No other information was provided. Additional information has been requested.  09/10/2007 Discharge Summary received for DOS 6/10-13/2007 for Dx of Intussusception.  Infant presented with hx of vomiting and one episode of blood per rectum.  On PE slightly tachycardic otherwise unremarkable.  Air contrast barium enema revealed Intussusception, unable to be fully reduced.  Taken to OR for Exploratory Lap with reduction of the Intussusception and appendectomy.				Y	Y	3			U	03/15/2007	06/10/2007	87	Unknown. Labs and Diagnostics:  Air contrast Barium Enema (+) for Intussusception	OTH	OTH	Unknown		None		WAES0707USA01506	1						1	Appendicectomy; Intussusception	FLU3~SANOFI PASTEUR~62283AA~6~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|RV5~MERCK & CO. INC.~1113F~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0285687	07/24/2007		2.0	2	.3	M	07/23/2007	Information has been received from a physician assistant concerning a 27 month old male with hypersensitivity to gelatin and a history of reactive airway disease and he had his skull suture lines released at birth, who on 17-DEC-2003 was vaccinated in the thigh with a dose of MMR II. Secondary suspect vaccinations given the same day included an in the other thigh a dose of VAQTA and a dose of influenza virus vaccine (unspecified). On 17-DEC-2003 the patient developed a systemic reaction after receiving his vaccinations. It was reported that within 30 minutes of being vaccinated he developed increased secretions, coughing and noisy breathing. Then he vomited and started to scratch his throat. About 45 minutes after receiving his vaccinations he developed a red confluent rash on his cheeks, right and left thighs and his arms. He was sleepy and later became fussy. The child was taken to the emergency room where he received an injection of BENADRL. He was sent home on oral BENADRYL. The child was then seen by an allergist who diagnosed him with an allergy to gelatin. On 18-DEC-2003 the patient recovered. no product quality complaint was involved. The patient's adverse events were considered to be an other important medical event by the reporter. Additional information has been requested.				Y					Y	12/17/2003	12/17/2003	0	Unknown	OTH	OTH	BENADRYL	Hypersensitivity	Reactive airways disease; Cranial sutures widening		WAES0707USA02359	1						1	Agitation; Breath sounds abnormal; Cough; Hypersensitivity; Rash erythematous; Salivary hypersecretion; Scratch; Somnolence; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~MERCK & CO. INC.~~UNK~UN~UN~HEP A (VAQTA)~1|MMR~MERCK & CO. INC.~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0286192	07/30/2007	MS	0.51	0	.5	M	07/24/2007	Inconsolable crying that day and days after (doctor said was colic). Red painful rash on neck and chest (doctor said it was eczema, prescribed hydrocortisone which did not help). A stiff neck (had to stop breastfeeding because baby could not turn head. Fevers (101.4) and odd colds. Blank stares and fatigue. Hearing loss (sensioneural, no family history of deafness) Clumsiness. Loss of appetite/overall change in his demeanor/normal behavior.   07/31/2007 MR received from current PCP beginning 6/25/2007.  Initial visit with PE WNL except for ear pulling.  Hearing test failed. ? speech delay.  Sent for ENT consult. PMH: reflux. F/U visit 7/16/07 with note of profound hearing loss gradually lost after 6 month shots. Assessment: Hearing loss.  10/08/2007 MR received from ENT for several OVs dated 7/3, 7/13/ and 7/17 2007.  Evaluation for recent failed hearing test.  Child passed newborn hearing screen and responded to sound up until about 6 months of age.  Child has had fluid in his ears but never treated for OM.  DX: Bilateral hearing loss. 1/19/2010 Child has permanent deafness. He is being considered for a cochlear implant.			Y	Y				Y	N	01/23/2007	01/23/2007	0	Labs and Diagnsotics:  Tympanogram with reduced TM compliance.  Auditory Brainstem Evoked Response testing showed severe peripheral hearing loss bilaterally. CT temporal bones unremarkable.	MIL	MIL	Ranitidine (Zantac syrup)	None	Reflux (From birth to 5 months old). PMH:  Reflux.  chronic nasal congestion.			1						1	Abdominal pain; Abnormal behaviour; Anorexia; Clumsiness; Crying; Deafness; Eczema; Erythema; Fatigue; Musculoskeletal stiffness; Nasopharyngitis; Pain; Pyrexia; Rash; Staring	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A021AA~3~~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U219AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1207R~3~~LL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08636H~2~~RL~PNEUMO (PREVNAR)~1	USA	Life Threatening,Disabling	Influenza
0286241	07/30/2007	PA	0.5	0	.5	F		Woke up morning of 7-11-07 obviously uncomfortable and throwing up small amounts of bile a few times every hour. Pediatrician referred us to the ER at 5:00; bloody diapers began around 6:30 PM. Ultrasound at 9:15 PM revealed intussusception. Drs attempted to reduce via enema 3 times unsuccessfully. Surgery at approx 1:00 AM on 7-12-07.  8/3/07 Received vax record which confirmed RO dose & lot # as reported. 8/14/07 Received hospital medical records which reveal patient experienced abdominal pain, bilious vomiting, decreased appetite & blood stools x 1 day.  Admitted 7/12-7/14/2007.  Exam revealed softly distended abdomen w/palpable mass at LLQ.  BE unsuccessful & surg consult obtained.  To OR for exp laparotomy & bowel resection FINAL DX: Intussusception, surgically reduced.				Y	Y	3			Y	01/22/2007	07/11/2007	170	Operative confirmation LABS: abdominal x-ray c/w IS.  abdominal US c/w large ileocolic IS in LLQ.  BE attempted x 2 unsuccessful.	PVT	UNK		None	None			1						1	Discomfort; Enema administration; Haematochezia; Intussusception; Surgery; Ultrasound abdomen abnormal; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC01B084CA~3~IM~~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~42260AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08672K~3~IM~~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1110F~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0263880	08/02/2007	IL	72.0	72		F	07/30/2007	Information has been received from a county health registered nurse concerning a 72 year old female patient with allergies to dust and mold and asthma, who on 29-SEP-2006 at 09:10 was vaccinated intramuscularly with a second dose of Pneumovax 23 (lot# 654981/0674F).  Concomitant therapy given on the same day at 09:10 IM included a dose of influenza vaccine (unspecified) (batch# 69480).  There was no illness at the time of vaccination.  On 29-SEP-2006 at 17:00, the patient developed right arm swelling, red and tender from the shoulder to the elbow.  The symptoms lasted for 3 days.  The patient was treated symptomatically.  Subsequently, the patient recovered.  Additional information is not expected.				Y					Y	09/29/2006	09/29/2006	0	Unknown	PUB	PUB		House dust allergy; mycotic allergy; asthma			WAES0701USA00805	1						2	Erythema; Oedema peripheral; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~0674F~2~IM~UN~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0264558	08/02/2007	OH	71.0	71		F	07/30/2007	Information has been received from a 71 year old female consumer with osteoporosis, cholesterol high, and arthritis who in 1998 was vaccinated with Pneumovax 23 (manufacturer unknown). At that time, she developed a fever. On 03-OCT-2006, the patient received revaccination with Pneumovax 23 in her arm. On 03-OCT-2006, she was also administered influenza virus vaccine (unspecified) in the other arm. Later that day, on 03-OCT-2006, she developed a swollen arm with red welts and a fever of 99.6 degrees Fahrenheit (F). She took ADVIL and used ice on her arm. On 04-OCT-2006, her arm continued to be swollen and her fever went up to 100.5 F. She sought medical attention. Her physician's office recommended hot compresses and she took BENADRYL. On 05-OCT-2006, she continued to have arm pain and swelling. At the time of reporting she was recovering. The consumer reported that she felt the events required intervention to prevent serious criteria (Other Important Medical Events). Additional information was received via phone call from the physician who reported that the patient's experience was not serious and was not considered to be an Other Important Medical Event. He described the patient's experience as a little red arm. The patient was treated with an antibiotic. The physician had not heard back from the patient and assumed that the patient had recovered. Additional information was received from the physician who reported he had not seen the patient for the reaction and was unclear on the details of the reaction. The physician believed the patient got a little bit of a red arm at the injection site. No additional information is expected.				Y					N	10/03/2006	10/03/2006	0	temperature measurement 10/03/06 99.6 F; temperature measurement 10/04/06 100.5 F	OTH	OTH		Osteoporosis; Cholesterol high; Drug hypersensitivity; Arthritis	Fever		WAES0610USA04281	1						2	Body temperature increased; Oedema peripheral; Pain in extremity; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~2~UN~UN~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0265196	08/02/2007	MD	61.0			F	07/30/2007	Information has been received from a 61 year old female consumer with sensitive skin, topical reactions to soy and nickel and environmental allergies who on 20-OCT-2006 was vaccinated with Pneumovax 23 (lot number 651404/0352F) in the left post lateral SC and Fluarix (lot 222AA) in the left deltoid. On 20-OCT-2006 the patient reported that her heart was racing the whole day, felt like her arm was in a car accident since it was severely sore at injection site, and her blood pressure was sky high with readings of 190/50 and a pulse of 106. The clinic where the patient received the vaccination referred her to the Emergency Department. During the Emergency Department visit on 20-OCT-2006, an EKG was done (results not reported) and a circle was drawn around the swelling at the injection site. On 22-OCT-2006, the patient visited the Emergency Department again. The large, diffuse swelling moved from the injection site and is hanging off the elbow. It was reported that the physician from the second Emergency Department visit did not feel that the area was infected. The physician also advised the patient to take ibuprofen and keep the area elevated. The symptoms of heart racing were resolved as of this visit (also reported as heart is also racing). On 23-OCT-2006, the patient continued to have symptoms of swelling, exhaustion and malaise. It was also noted that the patient had been previously vaccinated with Pneumovax 23 and Fluarix with no reported symptoms. Additional information has been requested.				Y					N	10/20/2006	10/20/2006	0	electrocardiogram 10/20/06; blood pressure 10/20/06 190/5; total heartbeat count 10/20/06 106	PUB	OTH		Disturbance of skin sensation; Hypersensitivity; Environmental allergy			WAES0610USA12531	1						2	Blood pressure; Electrocardiogram; Fatigue; Heart rate; Hypertension; Injection site pain; Injection site swelling; Malaise; No reaction on previous exposure to drug; Oedema peripheral; Palpitations	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~2|PPV~MERCK & CO. INC.~0352F~UNK~UN~UN~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0265493	08/02/2007	MO	62.0	62		M	07/30/2007	Initial and follow up information has been received from a health professional concerning a 63 year old male patient with no past medical history or allergies who on 17-OCT-2006 was vaccinated with a second dose of Pneumovax 23 (lot # 651357/0391F) IM into the right deltoid. Concomitant vaccination on 17-OCT-2006 included yearly dose of FLUZONE (lot # 42169NA) IM into the left deltoid. On 17-OCT-2006 the patient developed itching, redness and mild swelling and tender when pressed on at the elbow fold, approximately 5 inches below the injection site of the right deltoid. The reaction was noted in the injection site arm but not at the injection site and lasted approximately 72 hours. It was noted that the patient's wife (WAES # 0610USA12144) had an experience following vaccination with Pneumovax 23 (lot # 651357/0391F) and had requested a lot check. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the agency and was released by the regulatory agency. Additional information is not expected.									Y	10/17/2006	10/17/2006	0	None	PUB	OTH			None		WAES0610USA12114	1						2	Breast tenderness; Erythema; Oedema peripheral; Pruritus	FLU3~SANOFI PASTEUR~42169NA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0391F~2~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0265740	08/02/2007	IN	80.0	80		F	11/17/2006	Initial and follow-up information has been received from a registered nurse concerning an 80 year old female with no allergies or drug reactions, no illness at the time of vaccination and a history of an aortic valve replacement and a coronary bypass (May 2005) who on 31-OCT-2006 at 10:00 A.M. the patient was vaccinated intramuscularly in the left arm with a 0.5 ml dose of Pneumovax 23 (lot #651149/0088F).  Concomitant therapy included FLUVIRIN, CENTRUM SILVER, DETROL LA, LASIX, OS-CAL, lisinopril (manufacturer unknown), TOPROL XL TABLETS, potassium (unspecified), aspirin, OCUVITE.  On 01-NOV-2006 the patient contacted the home care agency to report that several hours after the vaccination, her whole left arm was painful with movement.  The patient stated that there was no swelling or redness but she did feel chills.  She did not take her temperature.  She self-medicated herself twice with LORTAB with some improvement in the discomfort.  The patient stated to the nurse I'm feeling much better and I don't need to see my doctor.  No lab tests were performed.  On 07-NOV-2006 the patient recovered.  No product quality complaint was involved.  In follow-up it was reported that the patient received the Pneumovax 23 at 10:00 A.M. and on 31-OCT-2006, the patient received FLUVIRIN (Lot # 71830) Chiron, intramuscularly into the right arm.  The patient reported that on 31-OCT-2006 at 5:00 P.M., she noticed that her left arm was painful upon movement, no swelling or redness noted at the injection site.  She reported that she began to chill but did not take her temperature.  Her arm was so painful that she took a LORTAB that she had on hand.  She went to bed at 9:00 P.M. and did sleep well.  On 01-NOV-2006, her arm was still painful upon movement and was slightly warm to touch.  There was no swelling or redness noted.  The patient took another LORTAB this A.M. and felt she did not need to see the physician.  It was reported that the patient recovered.  Additional information has been requested.  Correct lot # for PNEUMONIA vax.									Y	10/31/2006	10/31/2006	0	None	OTH	PVT	ascorbic acid; aspirin; OS-CAL; LASIX (FUROSEMIDE); PRINIVIL; TOPROL XL TABLETS; CENTRUM SILVER; OCUVITE; potassium (unspecified); DETROL LA		Aortic valve replacement; coronary bypass		WAES0611USA02390	1						2	Chills; Pain; Pain in extremity; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71830~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~0088F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0265790	08/02/2007	NY	74.0	74		F	07/30/2007	Information has been received from a licensed practical nurse concerning a 74 year old female with a thyroid condition, hypertension, cardiac condition and an allergy to contrast dye who on 23-OCT-2006 was vaccinated intramuscularly with a first dose of Pneumovax 23 (lot #651437/0899F).  Concomitant therapy included a dose of influenza virus vaccine (unspecified) and multiple unspecified medications.  That same day the patient experienced pain, induration of 6-8 cm, redness and warmth at the injection site and decreased use of her arm.  Unspecified medical attention was sought.  No lab studies were performed.  Treatment included cool compresses and TYLENOL.  At the time of report, the patient was recovering.  No product quality complaint was involved.  The records of testing prior to release of the lot in question have been checked and found to be satisfactory.  The lot met the requirements of the agency and was released.  No additional information is available.				Y					N	10/23/2006	10/23/2006	0	None	OTH	OTH	(therapy unspecified)	Thyroid disorder; hypertension; cardiac disorder; hypersensitivity			WAES0610USA14190	1						2	Injected limb mobility decreased; Injection site erythema; Injection site induration; Injection site pain; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0899F~1~IM~UN~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0266065	08/02/2007	WI	65.0			F	07/30/2007	Initial information from the consumer and follow-up information from a physician has been received concerning a 65 year old female with an allergy to penicillin and no medical history who on 16-OCT-2006 was vaccinated subcutaneously with a 0.5 ml dose of Pneumovax 23 (lot #651399/0486F).  Concomitant therapy given in the opposite arm included a dose of influenza virus vaccine (unspecified).  On 19-OCT-2006 at 0800 the patient experienced redness, swelling and pain at the injection site, chills, fever of 103, pain in the shoulder and neck, and severe pain and swelling in the arm.  Unspecified medical attention was sought.  The patient was treated with BENADRYL.  No lab studies were performed.  Subsequently the patient recovered.  No product quality complaint was involved.  Additional information is not expected.				Y					Y	10/16/2006	10/19/2006	3	body temp, 10/16/06, 103	PVT	OTH		Penicillin allergy			WAES0610USA12106	1						2	Body temperature increased; Chills; Injection site erythema; Injection site pain; Injection site swelling; Musculoskeletal pain; Neck pain; Oedema peripheral; Pain in extremity; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0486F~UNK~SC~UN~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0266532	08/02/2007	MD	7.0	7		M	07/30/2007	Information has been received from a licensed practical nurse concerning a 7 year old male patient with chronic asthma who on 30-OCT-2006 was vaccinated subcutaneously with a dose of Pneumovax 23 (Lot# 654981/0674F).  Concomitant vaccination the same day in the other arm included a dose of influenza virus vaccine (unspecified).  On 31-OCT-2006 the patient presented with an injection site reaction from the vaccination from Pneumovax 23.  The nurse reported the symptoms consisted of very red and very swollen area down to his elbow.  The nurse also reported that he had nausea and vomiting with severe headache.  The physician prescribed ZYRTEC and PHENERGAN.  On 02-NOV-2006, the patient was prescribed KEFLEX because the red area was getting larger. He completely recovered by 04-NOV-2006.  The caller requested a lot check of the vaccine to see if other patients had experienced AE's from this particular lot number.  The nurse further clarified that there were no other patients in her office who had any problems with this lot number.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.									Y	10/30/2006	10/31/2006	1	Unknown	UNK	UNK		Asthma			WAES0611USA04558	1						2	Headache; Injection site erythema; Injection site reaction; Injection site swelling; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0674F~UNK~SC~UN~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0266674	08/02/2007	CA	70.0	70		F	07/30/2007	Information has been received from a registered nurse concerning a 70 year old female who on 04-NOV-2006 was vaccinated with a second dose of Pneumovax 23, 0.5 ml, IM in the right deltoid and influenza virus vaccine (unspecified), IM, left arm. Previous vaccination with Pneumovax 23 was about 8-9 years ago. On 04-NOV-2006 about 2-3 hours after vaccination, the patient experienced soreness, redness, pain and swelling of the right arm. On 05-NOV-2006, the day after vaccination, the patient experienced chills, shakiness and low grade fever. The patient visited an urgent care center where she was ordered an antibiotic and BENADRYL. Four days later, the patient visited the urgent care center again since her arm was still hurting. The patient was then ordered Prednisone. On an unspecified date, laboratory tests were performed with results not reported. The nurse spoke with the patient on 13-NOV-2006 and the patient mentioned that her symptoms were improving. Additional information has been requested.				Y					N	11/04/2006	11/04/2006	0	body temp 11/05/06 low grade fever; laboratory test 11/05/06 unknown test-results not reported	OTH	OTH			Unknown		WAES0611USA04383	1						2	Body temperature increased; Chills; Erythema; Laboratory test; Oedema peripheral; Pain in extremity; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0882F~2~IM~UN~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0267607	08/02/2007	OH	79.0	79		F	07/30/2007	Information has been received from an occupational therapist concerning her 79 year old mother, with hypertension, who on 17-NOV-2006 in the afternoon was vaccinated with a second dose of Pneumovax 23 (1.0 ml) (lot # 655053/0743F), in the right deltoid. Concomitant therapy included blood pressure in the right deltoid. Concomitant therapy included blood pressure, glaucoma eye drops, alendronae sodium (MSD), ZESTERIL, hydrochlorothiazide, and FLUARIX (lot # AFLUA218BA) given IM in the deltoid. Subsequently, the patient developed cellulitis from injection site to wrist area. The patient was seen in urgent care center on 19-NOV-2006 and was given ROCEPHIN intramuscularly and then was started on KEFLEX (PO) on 20-NOV-2006. The patient had pain with movement, redness, and swelling. At the time of the report, the patient was recovering. There were no relevant diagnostic tests or laboratory data. Additional information is not expected.				Y					N	11/17/2006	11/17/2006	0	None	PVT	OTH	[composition unspecified]; [therapy unspecified], FOSAMAX; hydrochlorothiazide; ZESTRIL	Hypertension			WAES0611USA06194	1						2	Cellulitis; Erythema; Hypokinesia; Injection site cellulitis; Pain; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA218BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~2|PPV~MERCK & CO. INC.~0743F~2~IM~UN~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0268537	08/02/2007	IL	68.0	68		F	07/30/2007	Initial and follow-up information has been received from a registered nurse concerning a 68 year old female who on 09-NOV-2006, at 13:15, was vaccinated with IM, into the right deltoid, with a 0.5ml first dose of Pneumovax 23 concomitantly with a dose of Fluvirin IM into the left arm. On 09-JAN-2006, at 14:15 the patient experienced pain in the right arm and shoulder. The patient unable to life her arm by 15-NOV-2006. On 20-NOV-2006, the patient was referred to a rehabilitation specialist. The patient was treated with IM cortisone and ADVIL. Subsequently, the patient recovered. No further information is available.				Y					Y	11/09/2006	01/09/2007	61	Unknown	PUB	PVT			Unknown		WAES0611USA04907	1						2	Mobility decreased; Musculoskeletal pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~0618F~1~IM~UN~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0269796	08/02/2007	MA	58.0	58		F	07/30/2007	Initial and follow-up information has been received from a licensed practical nurse (LPN) concerning a 58 year old female with an allergy to sulfonamide, non-steroidal anti-inflammatory drugs, and lidocaine who on 15-DEC-2006 was vaccinated IM in the right arm with a dose of Pneumovax 23 (lot #651331/0577R).  The patient was vaccinated with a dose of influenza virus vaccine (unspecified) on the same day.  Other concomitant therapy included albuterol and FLONASE.  On 15-DEC-2006, at 17:00, the patient developed redness, warmth, and one inch thick swelling, over 4 in. X 8 in. area, in the arm she received vaccination with Pneumovax 23.  The patient also developed a low grade fever, and subsequently, was diagnosed with cellulitis.  The patient was treated with unspecified antibiotics.  The outcome of the patient's cellulitis was unknown.  No further information is expected.				Y					U	12/15/2006	12/15/2006	0	None	PVT	OTH	albuterol; FLONASE	Sulfonamide allergy; drug hypersensitivity			WAES0701USA04133	1						2	Cellulitis; Erythema; Oedema peripheral; Pyrexia; Skin warm	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0577R~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0269946	08/02/2007	IL	53.0	53		F	07/30/2007	Information has been received from a health professional concerning a 53 year old female with no pertinent medical history who on 04-NOV-2006, at 11:30, was vaccinated intramuscularly, into the right arm, with a first dose of Pneumovax 23 (lot #651400/0618F) concomitantly with a first dose of FLUVIRIN (lot #70384) intramuscularly into the left arm.  On 04-NOV-2006, at approximately 16:30, the patient experienced chills, fatigue, fever of 101.2 and redness, swelling and soreness in the affected arm.  The patient was unable to lift her arm above her head.  The patient was seen by her personal physician who placed her on therapy with BACTRIM.  There were no laboratory or diagnostic tests performed.  By 05-NOV-2006 the patient's arm was less swollen and red and the patient was released her physician to go on vacation.  Subsequently the patient recovered on 07-NOV-2006.  No additional information is expected.				Y					Y	11/04/2006	11/04/2006	0	None	PUB	PVT			None		WAES0702USA03320	1						2	Chills; Erythema; Fatigue; Hypokinesia; Pain; Pyrexia; Swelling; Chills; Erythema; Fatigue; Injected limb mobility decreased; Oedema peripheral; Pain in extremity; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70384~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0618F~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70384~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~0618F~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0272091	08/02/2007	CO	48.0	48		M	07/30/2007	Information has been received from a health professional concerning a 48 year old male with congenital heart disease, coronary artery disease, type II diabetes, hypertension, hyperbilirubinemia and history of hernia repair, family history of diabetes and heart disease and no known allergies who on 25-JAN-2007 at 4:30 PM was vaccinated with a first dose of Pneumovax 23 (0.5 ml) (lot # 655152/0889F), in the left arm. Concomitant therapy that day and time in the same arm included a first dose of Fluvirin (lot # 72223), in the left arm. Other concomitant therapy included metformin, Altace, baby aspirin, glipizide, Lipitor, Toprol and Bactrim. On 25-Jan-2007, in the evening, the patient had soreness, pain, redness and could not lift his arm over his head. The patient contacted the office on 26-JAN-2007 and came into the office and was treated with Advil and ice and sent home. The patient went to the emergency room on 27-JAN-2007 was evaluated and sent home. On 28-JAN-2007 the patient was admitted to the hospital after having had an influenza vaccine to the left upper extremity three days prior. He had returned one day before admission with extension of the redness, and arrangements were made for admission. It was also reported that he was seen in the ER two days before admission when he had some redness extending from the redness extending from the arm down to the forearm. It was reported that he was given Ancef and allowed to go home on Bactrim. He developed increased redness and swelling, as well as subjective fever and chills. He was sent in the emergency department, placed on vancomycin, and then admitted to observation. The patient did get itching of the neck and head with the second dose of vancomycin. It was reported on 29-JAN-2007 that an exam was remarkable for redness, swelling and tenderness of the arm, with extension down to the forearm. He got vancomycin last night and received some itching. He also got some oaxcillin, then switched to Invane. On 29-JAN-2007 the patient had chief complaint of left upper extremity swelling of some three days duration. The evening of vaccination he had more pain in the arm than usual. There was some discomfort on bending the elbow, however, if he took it slowly, there was no pain. There was no swelling around the elbow. There was no drainage from the injection site of the flu shot and he had no pain on motion around the shoulder. He had no fever or chills. He had no drainage. His glucose had stayed at about 200. A 13-point system review, was negative. Infectious disease was consulted and consented to follow the patient in the office and IV antibiotics, and then he was discharged to their office to be followed by a physician, IV daptomycin. The patient was discharged with a diagnosis of left upper extremity cellulitis, hypertension, controlled, stable coronary artery disease, diabetes mellitus type II, hyperbilirubinemia (question Gilbert's syndrome). The patient was discharged on Altace, aspirin, Glucophage, Glucotrol, metoprolol and simvastatin (MSD). The patient recovered. Additional information is not expected.				Y	Y	0			Y	01/25/2007	01/25/2007	0	blood pressure 01/29?/07 161/7, serum glucose 01/29?/07 200, serum glucose 01/29?/07 161	PVT	PVT	aspirin, lipitor, glipizide, metformin, TOPROL XL TABLETS, ALTACE, BACTRIM, vancomycin	Diabetes; Coronary artery disease; Type II diabetes mellitus; Hypertension; Hernia repair; Hyperbilirubinaemia; Heart disease congenital			WAES0702USA00351	1						2	Cellulitis; Chills; Erythema; Pain in extremity; Pyrexia; Swelling; Blood glucose abnormal; Blood pressure; Cellulitis; Chills; Discomfort; Erythema; Hypokinesia; Mobility decreased; Oedema peripheral; Pain; Pruritus; Pyrexia; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72223~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0889F~1~~LA~PNEUMO (PNEUMOVAX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~72223~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~0889F~1~UN~LA~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0274148	08/02/2007	NC	53.0	53		M	07/30/2007	Information has been received from a certified medical assistant concerning a 53 year old male with drug allergies to NAPROSYN and HALCION who on 13-NOV-2006 at 0915 was vaccinated with Pneumovax 23 (lot number 655290/0959F) intramuscular in left arm.  On 13-NOV-2006 at 0915, concomitant vaccination included FLUARIX (lot number AFLUA234AA) intramuscular in left arm.  Concomitant therapy also included DIOVAN, hydrochlorothiazide (manufacturer unknown), NIASPAN, aspirin, PLAVIX, ezetimibe (MSD), COREG, AMARYL, CADUET, LANTUS, nitroglycerin, ULTRACET, AVANDIA, metformin and HUMALOG.  On 14-NOV-2006, in the evening, the patient experienced fever of 103.6, axillary lymph nodes swollen/feels like a baseball in my armpit and headache.  The patient was treated with moist heat, cold compress and cephalexin.  On 19-NOV-2006, the patient recovered from fever of 103.6, axillary lymph nodes swollen/feels like a baseball in my armpit and headache.  Additional information is not expected.									Y	11/13/2006	11/13/2006	0	None	PVT	PVT	ULTRACET; CADUET; aspirin; COREG; PLAVIX; ZETIA; AMARYL; hydrochlorothiazide; LANTUS; HUMALOG; metformin; NIASPAN; nitroglycerin; AVANDIA; DIOVAN	Drug hypersensitivity			WAES0701USA03831	1						2	Cold compress therapy; Headache; Heat therapy; Lymphadenopathy; Pyrexia; Headache; Lymphadenopathy; Pyrexia	PPV~MERCK & CO. INC.~0959F~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA234AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~2|PPV~MERCK & CO. INC.~0959F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0277006	08/02/2007	NJ	63.0	63		F	07/30/2007	Information has been received from a registered nurse concerning a 63 year old female with diabetes and environmental allergies who on 10-OCT-2006 at 11:30 AM was vaccinated with a dose of Pneumovax 23 (0.5 ml) (lot # 651330/1048P), in the right deltoid intramuscularly.  Concomitant therapy included HUMULIN, HUMALOG, ACCUPRIL and diuretic.  There was no illness at the time of vaccination.  On the morning of 11-OCT-2006 in the AM her fasting blood sugar was 300, also reported as 294.  She was later able to go to work.  She had not received Pneumovax 23 in the past but had received the influenza vaccine last year without adverse symptoms noted.  The patient fully recovered.  Additional information has been requested.				Y					Y	10/10/2006	10/11/2006	1	blood glucose, 10/11/06, 300, fasting blood sugar; blood glucose, 10/11/06, 294, fasting blood sugar	PUB	OTH	diuretic (unspecified); HUMULIN; HUMALOG; ACCUPRIL	Diabetes; seasonal allergy			WAES0610USA08347	1						2	Blood glucose abnormal; Blood glucose increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~07278~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1048P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~1048P~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0277408	08/02/2007		17.0	17		F	07/30/2007	This case was received from another manufacturer (reference numbers A0648430A / 1-115313236) on 21 July 2007. The following information is verbatim as it appears in the other manufacturer's report: This case was reported by a healthcare professional and described the occurrence of miscarriage in a 17 year old female subject who was vaccinated with Boostrix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not provided. On an unspecified date the subject received unspecified dose of Boostrix (unknown). The subject participated in an observational study. On an unspecified date, an unspecified time after vaccination with Boostrix, the subject became pregnant. This was her first pregnancy. The subject was seen in the emergency room for vaginal bleeding and abdominal pain at approximately seven weeks of pregnancy. Per the reporter, 'this would indicate that she was vaccinated approximately 13 days prior to the last menstrual period prior to her pregnancy. On an unspecified date, an unspecified time after vaccination with Boostrix, the subject had a miscarriage. This case was assessed as medically serious. At the time of reporting the outcome of the events were was unspecified. Follow-up information received on 11 May 2007 indicated that the subject's last menstrual period was on 23 October 2006. On 13 November 2006, the subject received vaccination with Boostrix at 0.5 ml, intramuscularly in the left deltoid. On the same date, the subject received intramuscular injections of 0.5 ml Menactra and 0.5 ml Vaxigrip in the right deltoid. These vaccinations were also considered to be suspect. A spontaneous abortion began on 11 January 2007. The subject had an emergency room visit on 14 January 2007. The events resolved by 14 January 2007. In the reporter's opinion, the events were not related to Boostrix. An ultrasound dated 26 December showed that conception was 29 November 2006 and the subject was at 5 weeks and 6 days gestation. Ultrasound on 11 January 2007 showed a spontaneous abortion at 8 weeks and 1 day gestation. Vaxigrip lot# was reported as U2166KA. This lot# corresponds to Fluzone. Menactra lot# was reported as U1920AA. Boostrix lot# was reported as AC52B011BA.				Y					Y	11/13/2006	01/11/2007	59	An ultrasound dated 26 December 2006 showed that conception was 29 November 2006 and the subject was at 5 weeks and 6 days gestation. Ultrasound on 11 January 2007 showed a spontaneous abortion at 8 weeks and 1 day gestation.	UNK	UNK			The subject's medical history, concurrent conditions, and concurrent medications were not provided.		200702597	1						2	Abdominal pain; Abortion spontaneous; Drug exposure during pregnancy; Vaginal haemorrhage; Abdominal pain; Abortion spontaneous; Ultrasound scan abnormal; Vaginal haemorrhage	TDAP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~UN~TDAP (BOOSTRIX)~1|FLU3~SANOFI PASTEUR~U2166KA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|MNQ~SANOFI PASTEUR~U1920AA~UNK~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B011BA~UNK~IM~LA~TDAP (BOOSTRIX)~2	USA	Emergency room visit	Influenza
0286618	08/02/2007	LA				F	07/30/2007	Information has been received from a physician concerning a female patient who was vaccinated with a dose of Pneumovax 23. Other concomitant therapy included a dose of influenza virus vaccine (unspecified), an illegible therapy and budesonide (NASOCORT). On 17-FEB-2006, the patient experienced an injection site rash. Within 2 to 3 weeks (also reported as a few days), the patient recovered. The physician also reported on the patient's experienced with montelukast sodium (WAES # 0607USA00837). Additional information is not expected.									Y		02/17/2006		Unknown	OTH	OTH	[therapy unspecified], Nasacort		Unknown		WAES0607USA01157	1						1	Injection site rash	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0286728	08/02/2007	TX	62.0	62		F	07/30/2007	Information has been received from a 62 year old female with allergy to azithromycin (ZITHROMAX), acetaminophen (TYLENOL) and bacitracin zinc (+) neomycin sulfate (+) polymyxin B sulfate (NEOSPORIN) who on 04-OCT-2006 was vaccinated with a dose of PNEUMOVAX (0.5 ml), intramuscularly.  Concomitant therapy that day included FLUZONE (influenza virus split virion 3v vaccine inactivated).  Other concomitant therapy included eszopiclone (LUNESTA).  On 04-OCT-2006 the patient experienced chills, fever, and waves of pain.  The patient stated that it hurts to raise the arm she got vaccination in.  She also reported that the injection really hurt going in.  At the time of the report, the patient was recovering.  Unspecified medical attention was sought.  Additional information has been requested.				Y					N	10/04/2006	10/04/2006	0	None	OTH	OTH	LUNESTA	Drug hypersensitivity			WAES0610USA04303	1						1	Chills; Injected limb mobility decreased; Injection site pain; Pain; Pyrexia; Myalgia; Pain; Pyrexia	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~~UNK~UN~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0286806	08/02/2007	IN	29.0	29		M	07/30/2007	Initial and follow up information has been received from a licensed practical nurse concerning a 29 year old white male with type I diabetes mellitus for 22 years.  On 03-OCT-2006, at 4:15 PM, the patient was vaccinated intramuscularly in the right arm with the first 0.5 mL dose of PNEUMOVAX (lot #651320/1008P).  Concomitant therapy included a dose of influenza virus vaccine (unspecified).  On 03-OCT-2006, the patient developed extreme pain at injection site and muscle weakness in right arm at h.s (previously reported as could hardly move his arm).  It was very painful but there was no redness or swelling.  On 04-OCT-2006, at 4:00 AM, the patient went to the emergency room.  The patient was treated with acetaminophen (+) hydrocodone bitartrate (LORTAB) for pain and released.  No lab studies were performed.  On 06-OCT-2006, the patient had recovered from the events.  Additional information is not expected.				Y					Y	10/03/2006	10/03/2006	0	None	PVT	PVT		Type I diabetes mellitus			WAES0610USA07269	1						1	Injected limb mobility decreased; Injection site pain; Muscular weakness	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1008P~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0286812	08/02/2007		54.0	54		M	07/30/2007	Information has been received from a registered nurse concerning her husband. Additional information was received from a VAERS form via another company. A 54 year old male with sarcoidosis, migraine headaches, renal calculi, penicillin allergy and erythromycin allergy on 05-OCT-2006 was vaccinated with a dose of Pneumovax 23 (0.5 ml) (lot # 651332/1049F), subcutaneously (also reported as intramuscularly), in the right deltoid back of arm. Concomitant therapy that day included a dose of FLUZONE (lot # 112199AA); (many previous doses was reported), in the left deltoid. Other concomitant therapy included oxycodone, INDERAL and albuterol. The nurse stated that her husband received Pneumovax 23 in his right arm and the FLUZONE in his left arm. However, the chart documented Pneumovax 23 in the left arm and FLUZONE in the right arm. The nurse added that the vaccine administered in the right arm was placed low on the back of the arm near the elbow. On 06-OCT-2006 the patient complained of pain, erythema, and edema at the site of the injection in the right arm and was examined by his physician that day. The physician diagnosed an allergic reaction and prescribed BENADRYL with ice compresses. On 10-OCT-2006 the edema of the right arm extended to the wrist. The patient was examinated by his physician on that day and was prescribed a MEDROL dose pack. The patient had elected not to take the MEDROL at that time. The physician had suggested an allergy consult to determine if the patient exhibited allergy to either vaccine. It was also reported that on 05-OCT-2006 the patient's right arm lower towards back began to hurt immediately. It became red, hot, swollen from upper arm then spread towards then to the wrist, then it began itching. At the time of the report it was still tender to the touch. At the time of the report, the patient had not recovered. Additional information has been requested.				Y					U	10/05/2006	10/05/2006	0	None	OTH	OTH	albuterol; oxycodone; INDERAL	Sarcoidosis; Migraine; Calculus renal; Penicillin allergy; Allergic reaction to antibiotics			WAES0610USA08297	1						1	Hypersensitivity; Injection site erythema; Injection site oedema; Injection site pain; Oedema peripheral; Pruritus; Skin warm; Tenderness	FLU3~SANOFI PASTEUR~112199AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1049P~UNK~SC~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0286821	08/02/2007	OH				F	07/30/2007	Information has been received from an office staff member concerning a female adult patient who on 11-OCT-2006 was vaccinated with a first dose of Pneumovax 23 (0.5 ml) (lot # 651400/0618F), intramuscularly. Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient developed edema, redness and warmth at the injection site. At the time of the report, the patient was considered to be recovering. Additional information has been requested.				Y					N	10/11/2006	10/11/2006	0	Unknown	OTH	OTH			Unknown		WAES0610USA09388	1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0618F~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0286826	08/02/2007	MA	65.0			F	07/30/2007	Information has been received from a nurse concerning a female less than 65 years who on 10-OCT-2006 was vaccinated with a first dose of Pneumovax 23. Concomitant therapy included influenza virus vaccine (unspecified). On 12-OCT-2006 the patient experienced extreme pain, redness and swelling at the injection site, she was unable to use arm or hold pen, had a fever of 102 F, developed a rash on upper trunk and arms with some hives and nausea. On 13-OCT-2006 the patient experienced pain radiating down right leg following the sciatic nerve. The patient was treated with TYLENOL. At the time of the report, the patient had not recovered. Additional information has been requested.				Y					N	10/10/2006	10/12/2006	2	body temp 10/12/06 102 F	OTH	OTH			Unknown		WAES0610USA09801	1						1	Body temperature increased; Injected limb mobility decreased; Injection site erythema; Injection site pain; Injection site swelling; Nausea; Pain in extremity; Pyrexia; Rash; Sciatica; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0286832	08/02/2007	CA	46.0	46		M	07/30/2007	Information has been received from a registered nurse concerning a 47 year old male respiratory therapist with asthma, allergic rhinitis and allergies to AVELOX, SEPTRA, LEVAQUIN and a history of pneumonia multiple times, who on 09-OCT-2006 was vaccinated IM into the right deltoid with a first 0.5 ml dose of Pneumovax 23 (lot# 651401/0619F). Concomitant therapy included a dose of influenaz virus vaccine (unspecified) (batch# U2168A) into the left arm, ACCOLATE, (UNIDUR), INTAL, albuterol, PULMICORT, and calcium (unspecified). That night he had so much pain in his arm that he could not sleep on it. This was followed by a fever, intermittently to 38 degrees C, redness, and swelling. He began to feel a little bit better in the last 24 hours with no fever since 09-OCT-2006. On 13-OCT-2006, the patient woke up the erythema in the arm was descending down th biceps area toward the elbow. The patient was diagnosed with a severe systemic and local reaction. The patient was advised to continue to use an antihistamine and TYLENOL. The physician also gave the patient a prescription for KEFLEX 500 mg to use only if the patient developed shaking chills or a fever. If he did the patient would take one tablet 4 times day for 7 days and call the physician. At the time of this report, the patient had not recovered. No product quality complaint was involved. The nurse requested a lot check since she has never seen a reaction occur with the vaccine. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the standards of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.				Y					N	10/09/2006	10/09/2006	0	body temp 10/09/06 38 deg C	PVT	OTH	[therapy unspecified]; albuterol; PULMICORT; calcium (unspecified); INTAL; ACCOLATE	Asthma; Rhinitis allergic; Drug hypersensitivity	Pneumonia		WAES0610USA10697	1						1	Body temperature increased; Erythema; Local reaction; Pain in extremity; Pyrexia; Sleep disorder; Swelling	FLU3~SANOFI PASTEUR~U2168BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0619F~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0286950	08/02/2007		62.0	62		M	07/30/2007	Information has been received from a registered pharmacist concerning a 62 year old male with no medical history or drug reactions/allergies who in approximately 2001 (more than 5 years ago) may have been vaccinated with Pneumovax 23. On 14-OCT-2006, the patient was vaccinated with Pneumovax 23 (lot # 651399/0486F) 0.5 ml subcutaneously. Concomitant therapy included influenza virus vaccine (unspecified) also given on 14-OCT-2006. Several hours later on 14-OCT-2006, the patient experienced tenderness, warmth, swelling, and redness at the injection site with soreness of his whole arm with movement. The patient sought medical attention. The patient was treated with TYLENOL and BENADRYL. The events improved. At the time of reporting, the patient was recovering. Additional information has been requested.				Y					N	10/14/2006	10/14/2006	0	None	OTH	OTH			None		WAES0610USA10722	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0486F~2~SC~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0286952	08/02/2007		24.0	24		F	07/30/2007	Information has been received fro a pharmacist concerning a 24 year old female with an allergy to cephalosporins and no medical history, who on 14-OCT-2006 was vaccinated SC with a 0.5 mL dose of Pneumovax 23 (lot# 651399/0486F) and influenza virus vaccine (unspecified). Concomitant therapy included hormonal contraceptives (unspecified). Several hours later, the patient experienced tenderness, warmth, swelling, and redness at the injection site and soreness of the whole arm with movement. The patient was treated with BENADRYL and TYLENOL. ON 16-OCT-2006 the patient saw a doctor who ordered AUGMENTIN and VICODIN. It was noted that the patient was being referred to an Infectious Disease Specialist. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.				Y					N	10/14/2006	10/14/2006	0	Unknown	OTH	OTH	hormonal contraceptives	Drug hypersensitivity			WAES0610USA10738	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0486F~UNK~SC~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0286953	08/02/2007		29.0	29		F	07/30/2007	Information has been received from a pharmacist concerning a 29 year old female patient with no allergies or medical history reported who on 14-OCT-2006 at a pharmacy was vaccinated with a 0.5ml SC dose of Pneumovax 23 (lot # 651399/0486F). Secondary concomitant vaccination on 14-OCt-2006 included influenza virus vaccine (unspecified) (manufacturer unknown). Several hours later, on 14-OCT-2006 the patient experienced tenderness, warmth, swelling and redness at injection site and soreness of whole arm with movement. The patient was treated with TYLENOL and BENADRYL. She saw the doctor on 15-OCT-2006 when she also had a fever (103 degrees Fahrenheit) and chills. The doctor ordered prednisone and SEPTRA DS. The patient was referred to an infectious disease specialist. As of 17-OCT-2006 the patient had not yet recovered. Additional information has been requested.				Y					N	10/14/2006	10/14/2006	0	body temp 10/15/06 103 F	OTH	OTH	Unknown		None		WAES0610USA10740	1						1	Body temperature increased; Chills; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pain in extremity; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0486F~UNK~SC~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0286954	08/02/2007	NC	45.0	45		F	07/30/2007	Information has been received from a medical assistant concerning a 45 year old female patient who on 11-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot #651319/1007P). Concomitant therapy included Fluvirin (unspecified), administered at the same visit in separate arms (separate sites). On approximately 11-OCT-2006 the patient developed a reaction in arm where the Pneumovax 23 vaccine was administered that ranged from redness to blotchiness to pain; and visited the hospital for flu like symptoms (diarrhea and dizziness), but was not admitted. Subsequently, the patient was feeling better. The medical assistant requested a lot check. No product quality complaint was involved. The reporter indicated there were 4 other patients who developed similar reactions after receiving Pneumovax 23 vaccine (lot #651319/1007P). Follow up information has been received from the Certified Medical Assistant concerning the black patient with hypertension, high cholesterol, asthma, and an allergy to codeine who at 4:15 p.m. on 12-OCT-2006 was vaccinated IM in left deltoid with a dose of Pneumovax 23 vaccine (lot #651319/1007P). At 4:17 p.m. she was vaccinated in the right deltoid with a dose of Fluvirin. At 7:00 p.m. the patient went to the ER approximately 3 hours after the injection. She was dizzy, sick, reaction in arm, flu-like symptoms, did not feel well. She recovered from the above symptoms on 16-OCT-2006. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.				Y					N	10/12/2006	10/12/2006	0	Unknown	PVT	PVT		Drug hypersensitivity; Hypertension; Cholesterol high; Asthma			WAES0610USA10745	1						1	Diarrhoea; Dizziness; Influenza like illness; Injection site erythema; Injection site pain; Malaise; Rash macular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71353~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1007P~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0286956	08/02/2007	OH				M	07/30/2007	Information has been received from an office staff member concerning an adult male who on 10-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot # 651400/0618F). Concomitant therapy included influenza virus vaccine (unspecified). Subsequently the patient experienced edema, redness and warmth at the injection site. Additional information has been requested.									U	10/10/2006	10/10/2006	0	Unknown	OTH	OTH			Unknown		WAES0610USA10809	1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0618F~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0286965	08/02/2007	NC	84.0	84		F	07/30/2007	Information has been received from a medical assistant concerning a 84 year old female patient who on 11-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot #651319/1007P). Concomitant therapy included Fluvirin (unspecified), administered at the same visit in separate arms (separate sites). On approximately 11-OCT-2006 the patient developed a reaction in arm where the Pneumovax 23 was administered, that ranged from redness to blotchiness to pain. Medical attention was sought. Subsequently, the patient was feeling better. The medical assistant requested a lot check. No product quality complaint was involved. There were 4 other patients who experienced similar reactions after vaccination with Pneumovax 23. Follow up information has been received from the Certified Medical Assistant concerning the patient with hypertension and high cholesterol who on 11-OCT-2006 was vaccinated IM in left deltoid with a dose of Pneumovax 23 (lot #651319/1007P). On the same day she received Fluvirin in the right deltoid. The same day, she complained of splotchy left arm and redness from shoulder to elbow. It was sore per patient for 3-4 days after the shot was administered. The patient was reported as recovered on 14-OCT-2006. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.				Y					Y	10/11/2006	10/11/2006	0	Unknown	PVT	PVT		Cholesterol high; Hypertension			WAES0610USA1181	1						1	Injection site discolouration; Injection site erythema; Injection site pain; Rash macular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69428~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1007P~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0286966	08/02/2007	NC	54.0	54		F	07/30/2007	Information has been received from a medical assistant concerning a 54 year old female patient who on 11-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot #651319/1007P). Concomitant therapy included Fluvirin (unspecified), administered at the same visit in separate arms (separate sites). On approximately 11-OCT-2006 the patient developed a reaction in arm where the Pneumovax 23 was administered, that ranged from redness to blothiness to pain. Medical attention was sought. Subsequently, the patient was feeling better. The medical assistant requested a lot check. No product quality complaint was involved. Follow up information has been received from the Certified Medical Assistant concerning the patient with hypertension, type II diabetes mellitus, cholesterol, and allergies to KEFLEX, BIAXIN, and amoxicillin who on 8:15 a.m. on 11-OCT-2006 was vaccinated IM in right deltoid with a dose of Pneumovax 23 (lot #651319/1007P). Concomitant therapy included Flurivin, administered in the left deltoid at 8:10 a.m. the same day. It was reported that on the same day the patient's right arm got swollen and red with pain. She also stated that she wasn't feeling that well for several days after the vaccination. Her outcome was not reported. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.				Y					N	10/11/2006	10/11/2006	0	Unknown	PVT	OTH		Allergic reaction to antibiotics; Hypertension; Cholesterol; Type II diabetes mellitus			WAES0610USA11883	1						1	Erythema; Injection site discolouration; Injection site erythema; Injection site pain; Malaise; Oedema peripheral; Pain in extremity; Rash macular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70249~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1007P~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0286967	08/02/2007	NC	82.0	82		M	07/30/2007	Information has been received from a medical assistant concerning a 82 year old male patient who on 11-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot #651319/1007P).  Concomitant therapy included influenza virus vaccine (unspecified), administered at the same visit in separate arms (separate sites).  On approximately 11-OCT-2006 the patient developed a reaction in arm where the Pneumovax 23 vaccine was administered, that ranged from redness to blotchiness to pain.  Medical attention was sought.  Subsequently, the patient was feeling better.  The medical assistant requested a lot check.  No product quality complaint was involved.  The reporter indicated there were other patients who developed similar reactions after Pneumovax 23 vaccine was administered.  Follow up information has been received from the Certified Medical Assistant concerning the retired patient with an allergy to an unspecified numbing medication who on the morning of 11-OCT-2006 was vaccinated IM in right deltoid with a dose of Pneumovax 23 (lot #651319/1007P).  He received a dose of FLUVIRIN on the same morning in the left deltoid.  On the same day, the patient developed pain and redness in the right arm for several days.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.				Y					N	10/11/2006	10/11/2006	0	Unknown	PVT	OTH		Drug hypersensitivity			WAES0610USA11884	1						1	Erythema; Injection site erythema; Injection site pain; Injection site reaction; Pain in extremity; Rash macular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71033~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1007P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0286968	08/02/2007		74.0	74		F	07/30/2007	Information has been received from a registered nurse concerning a 74 year old female with steroid and codeine allergy who on 16-OCT-2006 was vaccinated with Pneumovax 23 vaccine (lot #651401/0619F), 0.5 ml, IM in the left deltoid.  Concomitant therapy included influenza virus vaccine (unspecified).  Subsequently on 17-OCT-2006, the patient experienced warmth, swelling, pain at injection and induration at injection (arm).  On an unspecified date, the patient experienced swelling that extended from the injection site to under the patient's arm pit.  On an unspecified date, the patient sought unspecified medical attention.  Subsequently on 19-OCT-2006, the patient recovered from warmth, swelling, pain, induration at injection (arm) and arm swelling.  Follow-up information has been received.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.				Y					Y	10/16/2006	10/17/2006	1		PVT	OTH		Drug hypersensitivity			WAES0610USA11975	1						1	Injection site induration; Injection site pain; Injection site swelling; Injection site warmth; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0619F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0286970	08/02/2007	AL	86.0	86		F	07/30/2007	Information has been received from a health professional concerning an 86 year old female with diabetes mellitus, hypertension and hyperlipidemia who on 19-OCT-2006 at 12 noon was vaccinated with a dose of Pneumovax 23 (lot # 651357/0391F also reported as 651400/0618F), intramuscularly in the right deltoid.  Concomitant therapy that day at 10:35 AM included FLUZONE (lot # U2202AA), intramuscularly in the left deltoid.  On 19-OCT-2006, during night the patient experienced rash all over her body, arm was red and arm was itching.  The patient's daughter called in AM of 20-OCT-2006 and asked if she could give her BENADRYL because arm was red/itching.  The doctor OK'd BENADRYL.  The patient recovered.  There were no relevant diagnostic tests or laboratory tests.  The reporter stated physician requested a lot check for lot# 651400/0618F.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.				Y					Y	10/19/2006	10/19/2006	0	None	PVT	PVT			Diabetes mellitus; hypertension; hyperlipidaemia		WAES0610USA12086	1						1	Erythema; Pruritus; Rash generalised	FLU3~SANOFI PASTEUR~U2202AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0618F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0286971	08/02/2007	AL	66.0	66		F	07/30/2007	Information has been received from a health care worker concerning a 66 year old female with allergy to sulfa and DARVON who on 12-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot # 651357/0391F), intramuscularly.  Concomitant therapy included ZANTAC, ALLEGRA and TIAZAC.  The patient developed redness of the arm in which she was vaccinated.  She also developed swelling and irritation in the area almost to her elbow.  The patient was last vaccinated with Pneumovax 23 in 2001.  The patient was reportedly almost recovered.  The reporter stated that the physician would like a lot check.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information has been requested.				Y					N	10/12/2006	10/12/2006	0	None	OTH	OTH	TIAZAC; ALLEGRA; ZANTAC	Sulfonamide allergy; drug hypersensitivity			WAES0610USA12089	1						1	Erythema; Oedema peripheral; Skin irritation; Injection site erythema; Injection site swelling	PPV~MERCK & CO. INC.~0391F~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0391F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0286971	08/02/2007	AL	66.0	66		F	07/30/2007	Information has been received from a health professional concerning a 66 year old female with drug hypersensitivity to DARVON and DEMEROL and a history of edema after vaccination with DECAVAC who on 12-OCT-2006, at 2:45 p.m., was vaccinated IM, into the right deltoid, with a dose of Pneumovax 23 (lot #651357/0391F).  Concomitant therapy included FLUZONE in the left deltoid.  On 14-OCT-2006 the patient's right arm became red and swollen down to the elbow.  The patient was seen in the clinic on 16-OCT-2006.  Subsequently, the patient recovered.  Additional information is not available.				Y					Y	10/12/2006	10/14/2006	2	None	PVT	PVT		Oedema	Drug hypersensitivity		WAES0612USA00223	1						2	Erythema; Oedema peripheral; Skin irritation; Injection site erythema; Injection site swelling	PPV~MERCK & CO. INC.~0391F~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0391F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0286973	08/02/2007	AL	72.0	72		F	07/30/2007	Information has been received from a health care worker concerning a 72 year old female patient with diabetes and hyperlipidemia and no drug reactions or allergies who on 16-OCT-2006 at 14:05 was vaccinated intramuscularly in the right deltoid with a dose of Pneumovax 23 (lot #651357/0391F).  The patient was also vaccinated intramuscularly with a dose of Fluzone (Lot # U2202AA) in the left deltoid on 16-OCT-2006.  Concomitant therapy included simvastatin (MSD), lisinopril (manufacturer unknown), verapamil and hydrochlorothiazide (manufacturer unknown).  On 17-OCT-2006 in the morning, the patient's proximal basilic vein area on her right arm became sore and very swollen and she developed redness in the vaccinated arm and irritation almost down to the elbow.  Unspecified medical attention was sought on 19-OCT-2006.  On 19-OCT-2006 the patient's blood pressure was 94/59 RUE (sitting).  It was noted that the right arm was mildly, minimally erythematous and did not hurt.  At the time of report the patient recovered but the outcome of the low blood pressure was unknown.  It was noted that the patient was last vaccinated with a dose of Pneumovax 23 in 1998.  No product quality complaint was noted.  The physician requested a lot check for lot number 0391F.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information is not expected.				Y					Y	10/16/2006	10/17/2006	1	blood pressure, 10/19/06, 94/59, RUE, sitting	PVT	PVT	HYDRODIURIL; PRINIVIL; ZOCOR; verapamil	Hyperlipidaemia; diabetes			WAES0610USA12103	1						1	Blood pressure; Erythema; Hypotension; Oedema peripheral; Pain in extremity; Skin irritation; Vein disorder	FLU3~SANOFI PASTEUR~U2202AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0391F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0286987	08/02/2007		65.0			M	07/30/2007	Information has been received from a 65 year old male consumer with asthma who on 20-OCT-2006 was vaccinated with Pneumovax 23 and influenza virus vaccine (unspecified). Concomitant therapy included SINGULAIR.  On 20-OCT-2006 the patient experienced arm got red and swollen at injection site, and also had an upset stomach, diarrhea and just wasn't feeling good.  The patient sought unspecified medical attention.  Subsequently, the patient is recovering from arm got red and swollen at injection site, upset stomach, diarrhea and just wasn't feeling good.  No further information is available.				Y					N	10/20/2006	10/20/2006	0	None	OTH	OTH	SINGULAIR	Asthma			WAES0610USA12533	1						1	Diarrhoea; Injection site erythema; Injection site swelling; Malaise; Stomach discomfort	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0286988	08/02/2007	CO	60.0	60		F	07/30/2007	Information has been received from a nurse concerning a 60 year old female who on 21-OCT-2006 was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 Lot # 651399/0486F).  Concomitant therapy included influenza virus vaccine (unspecified).  On 21-OCT-2006, post vaccination, the patient experienced nausea, chills, shivering, weakness and developed soreness, swelling and redness at the injection site.  The patient sought unspecified medical attention.  At the time of this report, the patient's nausea, chills, shivering, weakness and soreness, swelling and redness at the injection site persisted.  Additional information has been requested.				Y					N	10/21/2006	10/21/2006	0	None	OTH	OTH			Unknown		WAES0610USA12559	1						1	Asthenia; Chills; Injection site erythema; Injection site pain; Injection site swelling; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0486F~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287023	08/02/2007	TN	67.0	67		F	07/30/2007	Information has been received from an office manager concerning a 67 year old female with type II diabetes mellitus, neuropathy peripheral, allergies to penicillin, LEVAQUIN, adhesives from tape and history of right hip fracture and past breast cancer who on 23-OCT-2006 was vaccinated with a first dose of Pneumovax 23 (lot # 651357/0391F) (0.5 ml), intramuscularly in the left deltoid.  Concomitant therapy included a dose of influenza virus vaccine (unspecified), in the same arm but different area.  On 25-OCT-2006 the patient experienced cellulitis.  It started below the Pneumovax 23 injection site and spread to her elbow.  The reaction consisted of a red, hot, swollen area.  Redness and induration down left arm were also reported at 8:00 AM.  The patient was given KEFLEX, BENADRYL and KENALOG for the treatment.  On 08-NOV-2006 the patient recovered.  Additional information is not expected.				Y					N	10/23/2006	10/25/2006	2	Unknown	PVT	OTH		Type II diabetes mellitus; drug hypersensitivity; adhesive tape allergy; penicillin allergy; neuropathy peripheral	Hip fracture; breast cancer		WAES0610USA13947	1						1	Cellulitis; Erythema; Induration; Oedema peripheral; Skin warm	FLUX~UNKNOWN MANUFACTURER~71353~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0391F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287024	08/02/2007	NY	56.0	56		M	07/30/2007	Information has been received from a licensed practical nurse concerning a 56 year old male with a history of alcohol abuse and no history of drug reactions/allergies who on 24-OCT-2006 was vaccinated with Pneumovax (lot # 651437/0899F0 intramuscularly. Concomitant therapy included influenza virus vaccine (unspecified) given at the same visit. On 24-OCT-2006, the patient experienced pain and warmth at the injection site after vaccination with Pneumovax 23. The patient sought medical attention. No laboratory diagnostic tests were performed. Treatment included warm compresses, AUGMENTIN, and ADVIL. The patient improved while on therapy. At the time of reporting, the patient was recovering. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of Center for Biologics Evaluation and Research and was released by the regulatory agency. Additional information has been requested.				Y					N	10/24/2006	10/24/2006	0	None	OTH	OTH			Alcohol abuse		WAES0610USA14149	1						1	Injection site pain; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0899F~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287027	08/02/2007	TN	69.0	69		F	07/30/2007	Initial and follow-up information has been received from a healthcare worker (also reported as office manager) concerning a 69 year old female with chronic obstructive pulmonary disease and no history of drug reactions/allergies who on 23-OCT-2006 was vaccinated in the left deltoid with a second dose of Pneumovax 23 (lot # 651357/0391F) 0.5 ml intramuscularly. Concomitant vaccination on 23-OCT-2006 included a dose of influenza virus vaccine (unspecified) given in the same arm but in a different area. ON 25-OCT-2006, the patient sought medical attention by returning to the physician's office 2 days after receiving Pneumovax 23 with cellulitis. It started at the Pneumovax 23 vaccine site and spread down to her wrist. The reactions consisted of red hot swollen areas. Follow-up information from the reporter confirmed redness of upper arm, itching and induration. The patient was given KEFLEX, BENADYRL, and KENALOG for the treatment. Follow-up from the reporter noted that the patient was given KEFLEX one more course and BENADRYL cream for itching. At time time of reporting, the patient was recovering. Additional information is not expected.				Y					N	10/23/2006	10/23/2006	0	Unknown	PVT	PVT	Unknown	Chronic obstructive pulmonary disease	Immunisation		WAES0610USA14177	1						1	Cellulitis; Erythema; Injection site induration; Injection site pruritus; Oedema peripheral; Skin warm	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0391F~2~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287031	08/02/2007	NY	88.0	88		M	07/30/2007	Information has been received from an LPN concerning an 88 year old male patient with hypertension and hardening of arteries who on 18-OCT-2006 was vaccinated IM with a 2nd dose of Pneumovax 23 (lot #651437/0899F).  Concomitant therapy included influenza virus vaccine (unspecified), given at the same visit.  On 19-OCT-2006 the patient experienced local pain, tenderness, redness and warmth at the injection site after vaccination with Pneumovax 23.  Medial treatment was sought, and the patient was treated with cool compresses and TYLENOL.  Subsequently, the patient recovered.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  There was no product quality complaint involved.  Additional information has been requested.				Y					Y	10/18/2006	10/19/2006	1	Unknown	OTH	OTH		Hypertension; arterial calcification			WAES0610USA14226	1						1	Injection site erythema; Injection site pain; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0899F~2~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287034	08/02/2007					M	07/30/2007	Information has been received from a nurse concerning a male patient who on 24-OCT-2006 was vaccinated with a dose of Pneumovax 23 (Lot #651399/0486F) and a dose of influenza virus vaccine (unspecified) in the other arm.  Subsequently the patient experienced redness, swelling and warm to touch at the injection site.  The patient sought unspecified medical attention.  The patient took ibuprofen for the symptoms and recovered in less than 24 hours.  Additional information has been requested.				Y					Y	10/24/2006			Unknown	OTH	OTH	ibuprofen		Unknown		WAES0610USA14292	1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0486F~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287039	08/02/2007					F	07/30/2007	Information has been received from a nurse concerning a female patient (age unknown) who on 24-OCT-2006 was vaccinated with a dose of Pneumovax 23 (Lot# 651399/0486F) and a dose of influenza virus vaccine (unspecified) in the other arm.  Subsequently the patient experienced redness, swelling and warm to touch at the injection site.  The patient sought unspecified medical attention.  The patient was treated with TYLENOL and BENADRYL.  The patient's injection site redness, swelling and warmth resolved approximately 24 hours later.  Additional information has been requested.				Y					Y	10/24/2006			Unknown	OTH	OTH			Unknown		WAES0610USA15269	1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0486F~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287060	08/02/2007	CT	63.0	63		F	07/30/2007	Information has been received from a physician concerning a 63 year old female with sulfonamide allergy, allergy to aspirin and a history of right mastectomy who on 01-NOV-2006 was vaccinated IM with a 0.5 ml dose of Pneumovax 23 (lot #651325/1037P) concomitantly with a dose of influenza virus vaccine (unspecified).  It was reported that that physician had administered both vaccines in the left deltoid, 2 inches apart, because the right arm had poor circulation due to right mastectomy.  Other concomitant therapy included tamoxifen citrate.  On 01-NOV-2006, a few hours after vaccination, the patient experienced nausea and vomiting.  The patient was examined in the emergency room later that evening.  She was treated with unspecified IV fluids and anti-nausea medications and released.  On 02-NOV-2006, the patient recovered from nausea and vomiting.  Nausea and vomiting were considered to be other important medical events.  Additional information has been requested.				Y					Y	11/01/2006	11/01/2006	0	Unknown	OTH	OTH	tamoxifen citrate	Circulatory depression	Mastectomy; sulfonamide allergy; drug hypersensitivity		WAES0611USA01401	1						1	Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1037P~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287063	08/02/2007	IN	62.0	62		F	07/30/2007	Information has been received from a registered nurse concerning a 62 year-old female home health aid who on 24-OCt-2006 at 8:30 am was vaccinated subcutaneously in the right upper arm with a first dose of Pneumovax 23 (Lot #651399/0486F) and a dose of influenza (unspecified) in the other arm. Subsequently the patient experienced redness, swelling and warm to touch at the injection site. The patient sought unspecified medical attention. The patient recovered approximately 24 hours later. The nurse stated that the patient's reaction was reported to her incorrectly. She stated that the injection site redness, swelling, and warmth were due to the influenza vaccine and not the Pneumovax 23 vaccine. Additional information has been requested.				Y					Y	10/24/2006	10/24/2006	0	Unknown	PVT	PVT	Unknown		Unknown		WAES0611USA01486	1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0486F~1~SC~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287067	08/02/2007	CO	66.0			F	07/30/2007	Information has been received from a 66 year old female patient who on 17-OCT-2006 was vaccinated with a dose of Pneumovax 23.  Concomitant therapy included a dose of influenza virus vaccine (unspecified) at the same time, in the opposite arm.  The same day, the patient passed out twice, and developed redness, pain, and swelling in arm, and pain after receiving Pneumovax 23.  The patient went to the emergency room but was not admitted to the hospital.  She stated that although she received the flu vaccine the same day it was administered in the other arm and there was no reaction in that arm.  An EKG was performed (results not provided).  The patient indicated the events were improving but that she was not yet recovered.  The patient stated she had a reaction approximately 10 years ago (approximately 1996) but received both the influenza virus vaccine (unspecified) and the Pneumovax 23 in the same arm.  The reaction then was pain and swelling but not as severe.  No further information is available.				Y					N				electrocardiogram, 10/17?/06, results not reported	OTH	OTH			Unknown		WAES0611USA01641	1						1	Electrocardiogram; Erythema; Loss of consciousness; Oedema peripheral; Pain; Pain in extremity; Swelling	FLUX~UNKNOWN MANUFACTURER~~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287070	08/02/2007	PA	47.0			F	07/30/2007	Information has been received from a 47 year old female, registered nurse with a history of chronic asthma who on 03-NOV-2006 was vaccinated with Pneumovax 23. At the time that the patient received the Pneumovax 23 she was taking BACTRIM for a pre-existent sinusitis. The patient received on the same date influenza virus vaccine (unspecified) at a different site. The patient reported that within 24 hours, she had developed an injection site reaction that included: redness, swelling, local heat, and a fever of 102 degrees Fahrenheit. The patient's injection site redness, swelling, local heat had since improved except the patient's fever. The patient sought unspecified medical attention. Additional information is not expected.				Y					N	11/03/2006	11/03/2006	0	body temp 11/03/06 102 degre	OTH	OTH	BACTRIM	Asthma chronic; Sinusitis			WAES0611USA01946	1						1	Body temperature increased; Injection site erythema; Injection site swelling; Injection site warmth; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287073	08/02/2007	FL				M	07/30/2007	Information has been received from a registered nurse concerning a pediatric male patient who in approximately October 2006 (about a month ago), was vaccinated with a dose of Pneumovax 23.  Concomitant vaccine therapy included a dose of influenza virus vaccine (unspecified).  Shortly after receiving the vaccine, the patient developed a fever.  Unspecified medical attention was sought.  Subsequently, the nurse believed that the patient recovered with no problems.  No product quality complaint was involved.  Additional information has been requested.				Y					Y				Unknown	OTH	OTH			Unknown		WAES0611USA02286	1						1	Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287080	08/02/2007		61.0	61		F	07/30/2007	Information has been received from a registered nurse concerning a 61 year old female (weight 171#, height 62) with no known drug allergies who on 13-OCT-2006 was vaccinated with Pneumovax 23 (lot #651401/0619F), 0.5 ml, IM in the left deltoid.  Concomitant medication included influenza virus vaccine (CHIRON).  Previous vaccination with Pneumovax 23 in 2002 without problems.  Previous two vaccinations with influenza virus vaccine without problems.  Subsequently on 13-OCT-2006 at 03:45 pm, the patient returned to the physician's office with warmth, swelling, pain at injection and induration at injection (upper L arm).  Upon examination it was noted that the patient had left upper arm 2+ non pitting edema, mild warmth, erythema and tenderness.  The patient was treated with prednisone 10 mg tapered dose starting with 5Qday 4, 3, 2, 1 #15 and acetaminophen and VICODIN, PRN #15.  Subsequently a few days later, the patient recovered from warmth, swelling, pain, erythema and induration at injection (upper L arm).  Follow-up information has been received.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.				Y					Y	10/13/2006	10/13/2006	0		PVT	OTH			Unknown		WAES0611USA02943	1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site pain; Injection site swelling; Injection site warmth; No reaction on previous exposure to drug	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~3~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0619F~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287081	08/02/2007		57.0			M	07/30/2007	Information has been received from a registered nurse concerning a 57 year old male (weight 158.5#, height 69) with no known drug allergies who on 11-DEC-2006 was vaccinated with Pneumovax 23 (lot #651401/0619F), 0.5 ml, IM i the right deltoid. Concomitant medication included CHIRO														PVT	OTH			Unknown		WAES0611USA02944	1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0619F~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0287082	08/02/2007	NY	74.0	74		M	07/30/2007	Initial information has been received from a licensed practical nurse and a physician and follow up information was received from a registered nurse, concerning a 74 year old retired male with hypertension, coronary artery disease, hyperlipidema and chronic obstructive pulmonary disease who on 06-NOV-2006, was vaccinated intramuscularly in the right deltoid with a second dose of Pneumovax 23 (Lot# 651406/0620F).  Concomitant vaccination intramuscularly into the left deltoid a dose of influenza virus vaccine (unspecified) (Lot # 70618).  The licensed practical nurse reported that on 06-NOV-2006 the patient developed a local reaction after vaccination with Pneumovax 23.  His whole upper arm became red, warm and swollen to the elbow.  The physician diagnosed symptoms as cellulitis of right arm.  Unspecified antibiotics were prescribed.  It was also noted that his previous vaccination with Pneumovax 23 was given on 12-NOV-2001.  The registered nurse reported that the patient developed swelling and soreness at the injection site.  It was painful to move his right arm.  The area was red and warm to touch.  His body temperature was 97.2, blood pressure was 140/70, pulse 80 and respirations 20. After 2 days, symptoms began to improve.  By the third day (08-NOV-2006), the patient had recovered.  There was no product quality complaint involved.  There were no other adverse events noted by the patient.  Additional information is not expected.				Y					Y	11/06/2006	11/06/2006	0	blood pressure, 11/06/06, 140/70; total heartbeat count, 11/06/06, 80; vital sign, 11/06/06, 20, respirations; body temp, 11/06/06, 97.2	OTH	OTH		Hypertension; coronary artery disease; hyperlipidaemia; chronic obstructive pulmonary disease			WAES0611USA02965	1						1	Blood pressure; Body temperature decreased; Cellulitis; Erythema; Heart rate normal; Injected limb mobility decreased; Injection site pain; Injection site swelling; Local reaction; Oedema peripheral; Pain in extremity; Respiratory rate; Skin warm	FLUX~UNKNOWN MANUFACTURER~70618~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0620F~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287083	08/02/2007		34.0	34		F	07/30/2007	Information has been received from agency (mfr. no 236874K06USA) from a 34 year old female consumer with multiple sclerosis who in October 2006, was vaccinated with Pneumovax 23. Concomitant suspect therapy included REBIF and influenza virus vaccine (unspecified). In October 2006, the patient experienced fever and bruising with injection site during administration of interferon beta-1a. Therapy with interferon beta-1a continued. The outcome of the fever and injection site bruising was not reported. Additional information is not expected.									U	10/01/2006	10/01/2006	0	Unknown	OTH	OTH	Unknown	Multiple sclerosis			WAES0611USA03061	1						1	Injection site bruising; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0287102	08/02/2007	LA	37.0	37		F	07/30/2007	Information has been received from a registered nurse concerning a 38 year old female with a sulfonamide allergy and an allergy to REMICADE and no medical history who on 07-NOV-2006 was vaccinated subcutaneously with a 0.5 ml dose of Pneumovax 23 (lot #655500/1005F) in the right deltoid. Concomitant therapy included Fluvirin (manufacturer Novarits, lot #71926), PAXIL and sodium chloride injection. On 08-NOV-2006, the patient called the office and reported that the injection site arm was swollen, red and painful. The patient complained of her arm hurting. The patient was directed to use cold compresses and take TYLENOL as needed. No lab studies were performed. On an unspecified date, the symptoms went away and the patient recovered from the events. No product quality complaint was involved. Additional information is not expected.				Y					Y	11/07/2006	11/08/2006	1	None	PVT	PVT	PAXIL; sodium chloride	Sulfonamide allergy; Drug hypersensitivity			WAES0611USA03502	1						1	Injection site erythema; Injection site pain; Injection site swelling; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71926~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1005F~1~SC~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287162	08/02/2007		35.0	35		F	07/30/2007	This report was received from GlaxoSmithKline and was assigned manufacturer report A0626767A. This was originally reported by a pharmacist concerning a 35 year old hospitalized female with sickle cell beta thalassemia and in sickle cell pain crisis at the time of the vaccination. It was reported that the patient had a history of cellulitis following prior receipt of concomitant administration of influenza virus split virion 3v vaccine inactivated and pneumococcal 23v polysaccharide vaccine (date unknown). It was reported that the patient had received multiple unspecified concurrent medications. On 30-OCT-2006, the patient was vaccinated with pneumococcal 23c polysaccharide vaccine (lot # not reported) IM in the right thigh at 9:00 AM. On 30-OCT-2006, at 9:00 AM, the patient concomitantly received a dose of influenza virus split virion 3v vaccine inactivated (Fluarix) IM in the right thigh. At the time of the concomitant administration of pneumococcal 23v polysaccharide vaccine and influenza virus split virion 3v vaccine inactivated (Fluarix), 30-OCT-2006, the patient was hospitalized for sickle cell anemia. On 31-OCT-2006, 1 day after vaccination with pneumococcal 23v polysaccharide vaccine and influenza virus split virion 3v vaccine (Fluarix), the patient developed injection site cellulitis. The reporter did not specify at which site of injection the cellulitis occurred. The patient's hospitalization was extended as a result of the injection site cellulitis. The patient was treated with intravenous and oral clindamycin. At the time of this report, the patient had not recovered from the event. The pharmacist reported that she does not know if the injection site cellulitis was due to the pneumococcal 23v polysaccharide vaccine or the influenza virus split virion 3v vaccine inactivated (Fluarix). Additional information was received from the pharmacist who reported that on 31-OCT-2006, the patient developed pain and swelling at the injection site, presenting as cellulitis. A computed tomography (CT) scan was positive for diffuse subcutaneous edema in the right thigh. The patient was treated with clindamycin IV and orally. On 10-NOV-2006, the patient recovered. The pharmacist considered the injection site cellulitis to be disabling. The pharmacist considered the injection site cellulitis to be an Other Important Medical Event. Follow-up information was received from the PharmD. The patient had no history of smoking and rarely drank alcohol. In October 2004, the patient received both the flu vaccine and pneumonia vaccine. The patient had no documented reaction. According to the reporter, it was unknown if the patient had experienced any adverse events following previous vaccination with the flu vaccine or Pneumococcal 23v polysaccharide vaccine. On 30-OCT-2006, the patient received the received the first dose of pneumococcal 23v polysaccharide vaccine intramuscularly in the right thigh. The patient experienced injection site swelling and injection site pain on 31-OCT-2006. The patient was diagnosed with injection site cellulitis. A biopsy was not performed. The event resolved on 10-NOV-2006. The pharmacist considered the events were possibly related to vaccination with pneumococcal 23v polysaccharide vaccine and influenza virion 3v vaccine inactivated. No additional information is expected.							Y	Y	Y	10/30/2006	10/31/2006	1	computed axial 10/31?/06 - positive for diffuse subcutaneous edema in right thigh	PVT	OTH	Unknown	Sickle cell crisis, Sickle cell anaemia; Hospitalisation; Sickle-cell beta thalassemia; Non-smoker			WAES0611USA04670	1						1	Computerised tomogram abnormal; Injection site cellulitis; Injection site pain; Injection site swelling; Oedema; Vaccine positive rechallenge	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation,Disabling	Influenza
0287163	08/02/2007	WI	41.0			U	07/30/2007	Information has been received from a nurse concerning a 41 year old patient (sex not reported) with unspecified pertinent medical history and drug reactions/allergies who on approximately 13-NOV-2006 was vaccinated with Pneumovax 23 (lot # 651404/0352F, 651374/0485F, or 651321/1036P). Concomitant therapy included influenza virus vaccine (unspecified) given at the same time. On approximately 13-NOV-2006, the patient experienced swelling, redness, rash on the lower arm and pain. The patient sought medical attention. The outcome was not reported. All vaccines from these lot numbers had been discarded. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the agency and was released by the regulatory agency. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of agency and was released by the regulatory agency. Additional information has been requested.				Y					U	11/13/2006	11/13/2006	0	Unknown	OTH	OTH			Unknown		WAES0611USA04691	1						1	Erythema; Pain; Rash; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0352F~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287164	08/02/2007	WI	61.0			U	07/30/2007	Information has been received from a nurse concerning a 61 year old patient (sex not reported) who on 06-NOV-2006 was vaccinated with Pneumovax 23 (lot # 651404/0352F) IM in the left deltoid.  Concomitant therapy included influenza virus vaccine (unspecified) given at the same time.  On 06-NOV-2006, the patient experienced chills, achy and felt flu-like for 2 days.  It was also reported that the patient experienced swelling, redness, rash on the lower arm, and pain.  The patient sought medical attention.  On 07-NOV-2006, the patient recovered from the chills, achy, and flu-like feeling.  The outcome of the swelling, redness, rash and pain was not reported.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released by the regulatory agency.  This is a consolidation of WAES 0611USA04692 and 0701USA00012.  No additional information is available.				Y					Y	11/06/2006	11/06/2006	0	Unknown	OTH	OTH			Unknown		WAES0611USA04692	1						1	Chills; Erythema; Influenza like illness; Pain; Rash; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0352F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287166	08/02/2007	CO				F	07/30/2007	Information has been received from a certified medical assistant concerning an adult female (age not reported) who on an unspecified date was vaccinated intramuscularly with 0.5 mL of Pneumovax 23 (Lot# 651404/0352F). Concomitantly, the patient was vaccinated with influenza virus vaccine (unspecified). On an unspecified date, the patient developed an injection site reaction that included local heat, pain and redness at the injection site. The patient sought unspecified medical attention. At the time of this report, the patient had fully recovered from the events (date unknown). Additional information has been requested.				Y					Y				None	OTH	OTH			Unknown		WAES0611USA04911	1						1	Injection site erythema; Injection site pain; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0352F~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287170	08/02/2007	AR	12.0	12		M	07/30/2007	Initial and follow-up information has been received from a health professional and a consumer who reported that her 12 year old son, whose reported weight was 100 pounds and whose reported height was 67 inches with no drug reactions or allergies and no known illness at the time of vaccination who on 14-NOV-2006, at 2:30 P.M., was vaccinated subcutaneously into the right arm with Pneumovax 23, (Lot # 655588/0883F).  Concomitant medication included influenza virus vaccine (unspecified).  The reporter stated that her son was experiencing a local injection site reaction from Pneumovax 23.  The reaction consisted of quarter-size induration of redness on the arm accompanied by chills and fever.  The patient stated that the pain in his arm was so severe that on a pain scale of 1 to 10, it was 10.  The patient did not seek medical attention.  At the time of the report, the patient had not recovered.  In follow-up it was reported that the patient on 14-NOV-2006 at 5:00 P.M. developed a large, red, warm reaction at the injection site and later had chills.  The patient was treated with MOTRIN and used an ice pack.  The patient's temperature went to 102 degrees at 24 hours.  The patient also vomited.  No swelling of throat, wheezing, shortness of breath (SOB) or hives.  The reaction was up to 6 inches in size and lasted 4-5 days before resolution.  At the time of the patient's office visit the size was about 2 inches.  It was reported that the patient recovered on an unknown date.  Additional information has been requested.									N	11/14/2006	11/14/2006	0	Unknown	PVT	OTH			Unknown		WAES0611USA05049	1						1	Chills; Injection site erythema; Injection site induration; Injection site warmth; Local reaction; Pain in extremity; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0883F~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0287173	08/02/2007		55.0	55		F	07/30/2007	Information has been received from a registered nurse concerning a 55 year old female who on 07-NOV-2006 was vaccinated with Pneumovax 23 (lot #651406/0620F), 0.5 ml, SQ. Concomitant therapy included influenza virus vaccine (unspecified) which was given during the same visit but the vaccine was given at a different site. In November 2006, the patient was hospitalized for treatment with IV antibiotics because she developed a cellulitis shortly after her recent Pneumovax 23. The cellulitis was not responsive to oral antibiotics. On 16-NOV-2006, the nurse reported that the patient was discharged from the hospital. The outcome of the event was not reported. Cellulitis was considered to be serious due to hospitalization and other important medical event. Additional information has been requested.					Y		Y		U	11/07/2006	11/07/2006	0		OTH	OTH			Unknown		WAES0611USA05058	1						1	Cellulitis	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0620F~UNK~SC~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0287175	08/02/2007		50.0	50		M	07/30/2007	Information has been received from a registered nurse concerning a 56 year old male who on 07-NOV-2006 was vaccinated with Pneumovax 23, 0.5 ml, SQ.  Concomitant therapy included influenza virus vaccine (unspecified) which was received at the same visit but the vaccine was given at a different site.  It was reported that the patient developed a cellulitis shortly after his recent Pneumovax 23 and was treated with oral antibiotics.  The outcome of the cellulitis was not reported.  Cellulitis was considered to be an other important medical event.  Additional information has been requested.									U	11/07/2006	11/07/2006	0		OTH	OTH			Unknown		WAES0611USA05086	1						1	Cellulitis	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~SC~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0287179	08/02/2007	CA				M	07/30/2007	Information has been received from a physician concerning a male (age not reported) who on an unspecified date was vaccinated with Pneumovax 23. Concomitant suspect therapy included influenza virus vaccine (unspecified). The physician reported that the patient had received a combination of Pneumovax 23 and influenza virus vaccine (unspecified) and had been sick for a few days and had a pretty good reaction (date unknown). At the time of this report, the outcome of the events were unknown. Additional information has been requested.									U				Unknown	OTH	OTH	Unknown		Unknown		WAES0611USA05317	1						1	Hypersensitivity; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0287180	08/02/2007	CA				U	07/30/2007	Information has been received from a physician concerning his partner's patient (age and gender not reported) who on an unspecified date was vaccinated with Pneumovax 23 (unspecified). Subsequently, the patient developed a reaction after receiving a combination of Pneumovax 23 and influenza virus vaccine (unspecified). At the time of this report, the outcome of the event was unknown. Additional information has been requested.									U				Unknown	OTH	OTH	Unknown		Unknown		WAES0611USA05318	1						1	Hypersensitivity	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0287194	08/02/2007	FL				F	07/30/2007	Information has been received from a physician concerning a female patient who was vaccinated with a dose of Pneumovax 23.  The patient received a dose of influenza virus vaccine (unspecified) at the same time.  Subsequently, the patient developed an injection site reaction from the vaccination with Pneumovax 23.  It was reported that the patient's arm swelled up like a cellulitis.  She was treated with an unspecified antibiotic.  The patient's outcome was unknown.  Additional information has been requested.				Y					U				Unknown	OTH	OTH			Unknown		WAES0611USA05674	1						1	Injection site reaction; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287207	08/02/2007	OH	54.0	54		M	07/30/2007	Initial and follow-up information has been received from a pharmacist concerning a 54 year old male pharmacist who 21-NOV-2006, at 9:00 a.m., was vaccinated IM in the left arm with a second 0.5 ml dose of Pneumovax 23 (lot # 655669/1128F).  The same day, the patient was vaccinated in the same arm with a dose of influenza vaccine.  It was reported that the patient was vaccinated with a previous dose of Pneumovax 23 one year ago.  Other concomitant therapy included losartan potassium (MSD), sulfasalazine and VOLTAREN.  On 21-NOV-2006, at 3:00 p.m., the patient's cheeks were flushed, his hands felt cold and he had trouble focusing on work.  Unspecified medical attention was sought.  On 22-NOV-2006, the patient recovered from the attention disturbance.  The outcome of the patient's flushing and peripheral coldness was unknown.  No additional information is expected.				Y					Y	11/21/2006	11/21/2006	0	None	OTH	PVT	VOLTAREN; COZAAR mg; sulfasalazine mg		None		WAES0611USA06186	1						1	Disturbance in attention; Flushing; Inappropriate schedule of drug administration; Peripheral coldness	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1128F~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287222	08/02/2007	TX	48.0	48		F	07/30/2007	Information has been received from a health professional concerning a 48 year old female who on 14-NOV-2006 at 09:45 am was vaccinated with Pneumovax 23 (lot #651148/0087F), IM in the left deltoid and influenza virus vaccine (unspecified) (lot #AFLMA237), IM in the right deltoid (number of previous doses 15+).  Concomitant therapy was not reported.  On 14-NOV-2006, at approximately 09:52 am, the patient became flushed, mottled and heart rate was 96.  The patient then complained of heart palpitations, chest tightness, lightheadedness and shortness of breath.  Subsequently, the patient began feeling better approximately 5-10 minutes later.  The patient took BENADRYL, 25 mg by mouth.  The patient remained at work and returned to the flu shot site without any complaints.  The patient's skin was normal color, there was no rash or redness.  The patient denied chest heaviness or shortness of breath.  The patient recovered on 14-NOV-2006.  Additional information has been requested.									Y	11/14/2006	11/14/2006	0		OTH	OTH			Unknown		WAES0611USA06772	1						1	Chest discomfort; Dizziness; Dyspnoea; Flushing; Heart rate normal; Livedo reticularis; Palpitations	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLMA237~7+~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0087F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0287225	08/02/2007		78.0	78		F	07/30/2007	Information has been received from a pharmacist concerning a 78 year old female with high blood pressure who on 19-NOV-2006 was vaccinated IM with a 0.5 mL second dose of Pneumovax 23 (Lot# 655289/0958F), one to two years after her first dose. Concomitant vaccination on 19-NOV-2006 included a dose of influenza virus vaccine (unspecified). Other concomitant therapy included 2 unknown high blood pressure medications. On 21-NOV-2006 the patient was listless, tired, and had a headache. The patient sought unspecified medical attention. The patient's outcome was not reported. Additional information has been requested.				Y					U	11/19/2006	11/19/2006	0	None	OTH	OTH	[therapy unspecified]; [therapy unspecified]				WAES0611USA07031	1						1	Fatigue; Headache; Inappropriate schedule of drug administration; Listless	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0958f~2~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287236	08/02/2007	ID	32.0	32		F	07/30/2007	Initial and follow up information has been received from a pharmacist concerning a 32 year old female with no medical history who on 25-NOV-2006 was vaccinated with a first dose of Pneumovax 23 SC into the left deltoid (Lot # 655054/0749F).  Concomitant therapy included a dose of influenza virus vaccine (unspecified) (lot # AFLUA239AA) administered into the other arm (SC right deltoid) at the same visit (no reaction noted).  On approximately 26-NOV-2006 the patient developed a circular red area and swelling around the injection site (left deltoid) the day after vaccination.  The patient was told to take TYLENOL but the red area spread to a streak (8 to 10 inch line) that extended down her arm.  The patient went to a local urgent care clinic where the physician assistant treating her told her it was a staph infection from the Pneumovax 23 and prescribed an oral antibiotic.  She was diagnosed with cellulitis and it was reported given her history and presence of a hematoma this is most likely due to her pneumonia shot injection.  The patient had recovered on an unknown date.  The pharmacist confirmed proper aseptic vaccination technique was used.  No product quality complaint was involved.  A lot check was requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information is not expected.				Y					Y	11/25/2006	11/25/2006	0	Unknown	OTH	PVT			None		WAES0612USA00400	1						1	Cellulitis; Haematoma; Injection site erythema; Injection site streaking; Injection site swelling; Staphylococcal infection	FLUX~UNKNOWN MANUFACTURER~AFLUA239AA~UNK~SC~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0749F~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287238	08/02/2007	ID	36.0	36		F	07/30/2007	Information has been received from a Doctor of Pharmacy concerning a 38 year old female diabetic who on 30-NOV-2006 was vaccinated in the arm with her first dose of Pneumovax 23, lot #655055/0749F.  The patient also received an unspecified influenza virus vaccine in the other arm.  On the same day the patient developed a red area around the injection site approximately 5 inches in diameter.  The pharmacist indicated proper aseptic vaccination technique was employed and would like a lot check performed.  The patient's outcome was unknown.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Follow up information has been received from  Registered Pharmacist concerning the 36 year old patient (originally reported as 38), who on 30-NOV-2006 was vaccinated SQ in the left deltoid with her first dose of Pneumovax 23, lot #655054/0749F.  It was reported that: Aseptic technique was used; IM injection in left deltoid after prepping vial and arm with separate alcohol swabs.  No blood was noted upon needle withdrawal.  Patient noted no initial complaint.  Patient called the following day at approximately 10:00 a.m. noting inflamed left deltoid and a swollen area of approximately 5 inches by 6 inches.  She had called a physician; recommendations of ice/BENADRYL.  I reinforced those recommendations and strongly urged patient to follow up with physician and...pharmacy.  On 02-DEC-2006 the reporter called the patient, she was fine and the redness was resolving.  She was reported as recovered from inflamed left deltoid and swollen area.  Additional information is not expected.				Y					N	11/30/2006	11/30/2006	0	Unknown	OTH	OTH		Diabetes			WAES0612USA00460	1						1	Injection site erythema; Injection site inflammation; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0749F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287239	08/02/2007	FL	66.0	66		F	07/30/2007	Initial and follow up information has been received from a physician and an LPN concerning a 66 year old female patient who on 27-NOV-2006 was vaccinated in the right arm with a dose of Pneumovax 23, lot #651437/0899F.  A dose of Zostavax (MSD), lot #652966/0623F, was administered at the same time in the left arm.  The patient also received a dose of FLUZONE at the same office visit.  On 27-NOV-2006, within 24 hours, the patient developed a fever of 103 degrees.  It was also noted that on 27-NOV-2006 the patient developed redness (developed over 48 hours); and severe swelling in the right arm.  The patient said she received Zostavax (MSD) in the right arm, however the physician stated that Pneumovax 23 was given in the right arm and Zostavax (MSD) was given in the left.  The physician reported that her right arm had redness and swelling and spread to arm pit, measuring 8 by 3.  She was treated with BENADRYL and TYLENOL, and DARVOCET was given for pain.  The nurse stated that the patient called the office to say that she had developed shingles in the arm in which she was vaccinated with Pneumovax 23 (Zostavax (MSD) was given in a different arm).  The patient refused to come into the office so that the physician could evaluate or confirm what the patient was saying.  As of 01-DEC-2006, the patient was recovering; all symptoms were much improved.  Additional follow up information has been received concerning the female with a history of fever after flu vaccination approximately 10 years ago who on 27-NOV-2006 was given her first dose of Pneumovax 23, lot #651437/0899F in her right arm; and her first dose of Zostavax (MSD), lot #652966/0623F in her left arm.  Several hours after the injection the patient reported right arm redness and swelling 8 X 3; and chills and subjective fever on 30-NOV-2006.  An office visit was recommended but the patient declined.  Treatment included ice-packs.  On 19-JAN-2007 the patient received MEDRO DOSEPAK and VICODIN for resultant myalgia in the arms.  A neurology consult was recommended on 19-JAN-2007 but the patient has not seen a neurologist.  Additional information is not expected.				Y					N	11/27/2006	11/27/2006	0	erythrocyte, 01/26/07, WNL; serum creatine kinase, 01/26/07, WNL; serum C-reactive protein, 01/26/07, WNL; serum vitamin B(12), 01/26/07, WNL; complete blood cell, 01/26/07, WNL; serum folate, 01/26/07, WNL	PVT	OTH			Fever; immunisation		WAES0612USA00506	1						1	Blood creatine phosphokinase normal; Blood folate normal; C-reactive protein normal; Chills; Erythema; Full blood count normal; Herpes zoster; Myalgia; Oedema peripheral; Pyrexia; Red blood cell scan; Vitamin B12 normal	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0899F~1~UN~RA~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~0623F~1~UN~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0287431	08/02/2007	KS	71.0			F	07/30/2007	Information has been received from a physician concerning a 71 year old female who on 14-DEC-2006 was vaccinated with a dose of Pneumovax 23 (Lot #651328/1046P).  Concomitant therapy given on the same day included a dose of influenza virus vaccine (unspecified).  On 14-DEC-2006, the patient developed irritation and swelling around the site of injection.  Unspecified medical attention was sought.  No laboratory studies were performed.  At the time of this report, the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.				Y					N	12/14/2006	12/14/2006	0	None	OTH	OTH			Unknown		WAES0612USA02925	1						1	Injection site irritation; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1046P~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287448	08/02/2007	MI	44.0	44		F	07/30/2007	Information has been received from a certified medical assistant concerning a 44 year old female with no medical history and no known allergies who on 28-NOV-2006 was vaccinated with Pneumovax 23 (0.5 ml) (lot # 651437/0899F), in the left deltoid. Concomitant therapy that day included influenza virus vaccine, in the left deltoid, but different site, and a tetanus toxoid, in the right arm. On 30-NOV-2006 the patient experienced painful, swollen and red injection site from deltoid around to the armpit of the same arm. On 01-DEC-2006 the patient took over the counter antihistamines. The patient was instructed to take BENADRYL. The patient recovered. Additional information is not expected.				Y					Y	11/26/2006	11/28/2006	2	None	PVT	PVT			None		WAES0612USA03590	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0899F~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~UN~RA~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0287450	08/02/2007	MI	51.0	51		F	07/30/2007	Information has been received from a certified medical assistant (CMA) concerning a 51 year old female with multiple sclerosis and no known allergies who on 02-DEC-2006 was vaccinated with first dose of Pneumovax 23 (lot # 651437/0899F) in left deltoid.  Also on 02-DEC-2006, the patient was vaccinated with flu vaccine in her right arm.  It was documented on the patient's chart on 07-DEC-2006, that on an unspecified date, the patient developed painful, swollen, and red injection site reaction from the deltoid around to the armpit of the same arm.  The patient sought medical attention.  No lab diagnostic studies were performed.  At the time of reporting, the patient had recovered.  Additional information was received from the physician's office.  It was reported that on 07-DEC-2007, the patient had called the office saying her left arm was very sore and slightly swollen at the injection site.  No other problems, the patient recovered.  No additional information is expected.				Y					Y	12/02/2006	12/07/2006	5	None	PVT	PVT		Multiple sclerosis			WAES0612USA03829	1						1	Injection site erythema; Injection site pain; Injection site swelling; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0899F~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287454	08/02/2007	CO	20.0	20		M	07/30/2007	Information has been received from a certified medical assistant concerning a 20 year old male with a history of respiratory tract infection who on 20-DEC-2006 was vaccinated SC with a 0.5 mL dose of Pneumovax 23 (Lot# 655291/0985F).  Concomitant vaccination on 20-DEC-2006 included a dose of influenza virus vaccine (unspecified) and AUGMENTIN.  On 21-DEC-2006 the patient experienced an 8 centimeter area that was red, warm and swollen and had a temperature of 101.  It was reported that the patient was recovering.  The patient sought unspecified medical attention.  Additional information has been requested.				Y					N	12/20/2006	12/21/2006	1	body temp, 12/21/06, 101	OTH	OTH	AUGMENTIN		Respiratory tract infection		WAES0612USA04130	1						1	Body temperature increased; Erythema; Oedema peripheral; Skin warm	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0985F~UNK~SC~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287456	08/02/2007	WI	41.0	41		F	07/30/2007	Information has been received from a registered nurse concerning a 41 year old female with allergies to diazepam and furosemide who on 25-OCT-2006 was vaccinated intramuscularly in the right deltoid with a dose of Pneumovax 23 (lot 651321/1036F). The patient was concomitantly vaccinated with influenza virus vaccine (unspecified) in the left deltoid. On 26-OCT-2006, the patient's arm was sore at site. The arm swelled in deltoid area, became red in deltoid area and under arm into the breast area. The area throbbed with pain for one week. The patient reported that it felt like a brick on her chest. Her eyes were watering and crusty for 3 days, and her nose ran. The patient was treated with diphenhydramine HCl. Subsequently, the patient recovered in one week. Additional information is not expected.									Y	10/25/2006	10/26/2006	1	Unknown	PVT	OTH		Drug hypersensitivity			WAES0612USA04182	1						1	Chest discomfort; Injection site erythema; Injection site pain; Injection site swelling; Lacrimation increased; Mucosal erosion; Pain; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1036P~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0287458	08/02/2007	NY	67.0	67		M	07/30/2007	Information has been received from a licensed practical nurse concerning a 67 year old male with no relevant medical history or illness at the time of vaccination who on 05-DEC-2006 was vaccinated intramuscularly in the right deltoid with a 0.5 mL dose of Pneumovax 23 (lot 655152/0889F).  On 05-DEC-2006, the patient was concomitantly vaccinated intramuscularly in the left deltoid with a dose of FLUVAX (lot U2199AA).  On 06-DEC-2006, the patient developed redness and swelling at the injection site.  The patient presented in the office on 07-DEC-2006.  The patient's arm appeared swollen, and he was instructed to place ice on his arm.  Subsequently, the patient recovered.  The nurse requested a lot check be performed on lot 655152/0889F.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  No additional information is expected.									Y	12/05/2006	12/06/2006	1	Unknown	PVT	PUB			None		WAES0701USA00058	1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2199AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0889F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0287468	08/02/2007	CA				F	07/30/2007	Information has been received from a certified medical assistant concerning an adult female who was recently vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 (lot 651319/1007P).  The patient was concomitantly vaccinated with influenza virus vaccine (unspecified).  Subsequently the patient developed injection site pain, redness and swelling.  The patient sought medical attention and was treated with ADVIL.  Subsequently, the patient recovered.  Additional information has been requested.				Y					Y				Unknown	OTH	OTH			Unknown		WAES0701USA00732	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1007P~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287471	08/02/2007	TX	51.0			M	07/30/2007	Information has been received from a health professional (medical assistant) concerning an approximately 51 year old male who, on an unspecified date, was vaccinated with a dose of Pneumovax 23 (Lot# 651437/0899F).  Concomitant vaccination included a dose of influenza virus vaccine (unspecified).  Subsequently the patient developed bad swelling of the right shoulder at the injection site.  The medical assistant noted the patient was in bad condition.  The patient was seen in the emergency room but not admitted to the hospital. It was also reported that the patient recovered (date not reported).  Additional information has been requested.				Y					Y				Unknown	OTH	OTH			Unknown		WAES0701USA00772	1						1	Injection site swelling; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0899F~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287483	08/02/2007	CO				F	07/30/2007	Information has been received from a certified medical assistant concerning an adult female (age not reported) who on an unspecified date was vaccinated intramuscularly with 0.5 mL of Pneumovax 23 (Lot# 651404/0352F).  Concomitantly, the patient was vaccinated with influenza virus vaccine (unspecified).  On an unspecified date, the patient developed an injection site reaction that included local heat, pain and redness at the injection site.  The patient sought unspecified medical attention.  At the time of this report, the patient had fully recovered from the events (date unknown).  Additional information has been requested.				Y					Y				None	OTH	OTH			Unknown		WAES0701USA01404	1						1	Injection site erythema; Injection site pain; Injection site reaction; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0352F~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287484	08/02/2007	CO				F	07/30/2007	Information has been received from a certified medical assistant concerning an adult female (age not reported) who on an unspecified date was vaccinated intramuscularly with 0.5 mL of Pneumovax 23 (Lot# 651404/0352F).  Concomitantly, the patient was vaccinated with influenza virus vaccine (unspecified).  On an unspecified date, the patient developed an injection site reaction that included local heat, pain and redness at the injection site.  The patient sought unspecified medical attention.  At the time of this report, the patient had fully recovered from the events (date unknown).  Additional information has been requested.				Y					Y				None	OTH	OTH			Unknown		WAES0701USA01405	1						1	Injection site erythema; Injection site pain; Injection site reaction; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0352F~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287505	08/02/2007	ME	24.0	24		F	07/30/2007	Information has been received from a physician concerning a 24 year old female with asthma who on 17-JAN-2007, at 14:00, was vaccinated with a first dose of Pneumovax 23 (lot #654977/0888F) concomitantly with a dose of influenza virus vaccine (unspecified).  Other concomitant therapy included FLOVENT, albuterol and hormonal contraceptives (unspecified).  On 18-JAN-2007, at 15:00, the patient developed a fever as high as 103 and shaking chills despite therapy with TYLENOL.  The patient also experienced nausea, headaches, and pain and mild swelling at the injection site.  The patient sought medical attention and was treated with ADVIL, TYLENOL and supportive measures.  There were no laboratory or diagnostic tests performed.  On 19-JAN-2007, the patient recovered.  Additional information has been requested.				Y					Y	01/17/2007	01/18/2007	1	None	PVT	PVT	albuterol; FLOVENT; hormonal contraceptives	Asthma			WAES0701USA03508	1						1	Chills; Headache; Injection site pain; Injection site swelling; Nausea; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0888F~1~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287506	08/02/2007	ME	26.0	26		F	07/30/2007	Information has been received from a physician concerning a 26 year old female with no illness at the time of being vaccinated, asthma, and no history of drug reactions/allergies who on 17-JAN-2007 was vaccinated with first dose of Pneumovax 23 (lot # 654977/0888F) in the deltoid at 8:30 AM.  Concomitant therapy included influenza virus vaccine (unspecified) was also given on 17-JAN-2007.  Other concomitant therapy included birth control, ADVAIR, albuterol, and ZYRTEC.  On 18-JAN-2007, at 8 AM, the patient experienced fever, nausea, chills, dizziness, swelling, redness, and soreness at the injection site.  The patient sought medical attention.  The injection site had a softball size swelling with tenderness.  Treatment was supportive.  No diagnostic studies were performed.  At the time of reporting, the patient was recovering.  Additional information was received from the physician.  The patient was treated with non-steroidal anti-inflammatory drugs (NSAIDS), rest, and fluids.  On 20-JAN-2007, the patient recovered. No additional information is expected.				Y					Y	01/17/2007	01/18/2007	1	temperature measurement, 01/18/07, fever	PVT	OTH	albuterol; ZYRTEC; ADVAIR; hormonal contraceptives		Unknown		WAES0701USA03543	1						1	Body temperature increased; Chills; Dizziness; Injection site erythema; Injection site pain; Injection site swelling; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0888F~1~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287527	08/02/2007	DE	51.0	51		M	07/30/2007	information has been received from a certified medical assistant concerning a 51 year old male with high blood pressure, obesity and no known allergies or adverse drug reactions reported. On 25-JAN-2007, the patient was vaccinated intramuscularly in the right deltoid with 0.5 mL of Pneumovax (lot#654977/0888F). At the same time, the patient received influenza virus vaccine (unspecified) in the left arm. Concomitant therapy included LOTREL. The following day, the patient developed a high fever, aches and swollen right arm. It was reported that the patient was also nauseated. The patient sought unspecified medical attention. The patient received an injection of DEPO-MEDROL and an order for MEDROL DOSEPAK. the symptoms had resolved. At the time of this report, the patient had recovered from the events (date unknown). Additional information has been requested.				Y					Y	01/25/2007	01/26/2007	1	None	OTH	OTH	LOTREL	Blood pressure high; obesity			WAES0702USA00654	1						1	Nausea; Oedema peripheral; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0888F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287533	08/02/2007	UT	87.0	87		F	07/30/2007	Information has been received from an 87 year old female with allergy to sulfa drugs and a history of gall bladder removal, who on 19-OCT-2006 was vaccinated by injection with a single dose of Pneumovax 23.  The patient concomitantly was vaccinated with influenza virus vaccine (unspecified), (name and manufacturer unknown) and other concomitant therapy included LASIX, DIOVAN and PROTONIX.  On the same day, 19-OCT-2006, the patient began to experience severe burning feelings inside her entire body.  The patient reported that this only occurred at night and it had occurred every single night since this began.  She said that the outside of her body is cool even though she was burning up inside.  She said that she was convinced that this was due to the Pneumovax 23, because in the past years she had received the same flu vaccine and had never had any adverse reactions from it.  The patient sought unspecified medical attention.  She added that she had gone for many different types of tests, but her physicians could not find anything to explain what she was experiencing.  Additional information has been requested.				Y					N	10/19/2006			She added that she had gone for many different types of tests, but her physicians could not find anything to explain what she was experiencing.	OTH	OTH	LASIX (FUROSEMIDE); PROTONIX; DIOVAN	Sulfonamide allergy	Cholecystectomy		WAES0702USA01245	1						1	Burning sensation	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287649	08/02/2007	FL	47.0			F	07/30/2007	Information has been received from a consumer concerning his wife, and follow up information has been received a Nurse Practitioner concerning the patient, a 47 year old obese female diabetic (well-controlled) with high cholesterol, high blood pressure, fibromyalgia, an allergy to penicillin, venous insufficiency, and a Basal Metabolic Index (BMI) of 35, who in 2005 was vaccinated with a first dose of Pneumovax 23. Concomitant therapy included metformin, COREG, quinapril HCl, estradiol, simvastatin (MSD), LEXAPRO, LUNESTA, ADDERALL TABLETS, KADIAN, LASIX, cyclobenazeprine HCl (MSD), and MSIR. In December 2006, the patient received Pneumovax 23 two years in a row. An unspecified flu shot was given at the same time. Since then she has had edema of both arms and legs. The day she received Pneumovax 23 vaccine her arm began to swell around the injection site, then spread to her back, shoulders, torso and legs. She then developed edema. It was reported that her feet and legs were discolored and that her skin is so tight it looks like it may break. The patient was seen by an endocrinologist and later by a cardiologist who ruled out congestive heart failure. The patient was treated with LASIX 80 mg TID. She was complaining of neuropathy symptoms. The patient's symptoms persisted. Additional information has been requested.				Y					N	12/01/2006	12/01/2006	0	Unknown	OTH	OTH	ADDERALL TABLETS; COREG; FLEXERIL; LEXAPRO; estradiol; LUNESTA; LASIX (FUROSEMIDE); metformin; KADIAN; MSIR; quinapril hydrochloride; ZOCOR	Obesity; Diabetes; Cholesterol high; Blood pressure high; Fibromyalgia; Penicillin allergy; Venous insufficiency			WAES0703USA00581	1						1	Inappropriate schedule of drug administration; Injection site swelling; Neuropathy; Oedema peripheral; Skin discolouration; Skin tightness	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~2~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287666	08/02/2007	TX	51.0			F	07/30/2007	Information has been received from a health professional (medical assistant) concerning an approximately 51 year old female who, on an unspecified date, was vaccinated with a dose of Pneumovax 23 (Lot# 651437/0899F).  Concomitant vaccination included a dose of influenza virus vaccine (unspecified).  Subsequently the patient developed bad swelling of the right shoulder at the injection site.  The medical assistant noted the patient was in bad condition.  The patient was seen in the emergency room but not admitted to the hospital.  It was also reported that the patient recovered (date not reported).  Additional information has been requested.				Y					Y				Unknown	OTH	OTH			Unknown		WAES0703USA02221	1						1	Injection site swelling; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0899F~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287720	08/02/2007	PA				F	07/30/2007	Information has been received from a registered nurse concerning a female (age unknown) who, on an unspecified date, was vaccinated with a dose of Pneumovax 23.  Concomitant therapy included influenza virus vaccine (unspecified).  Subsequently, on an unspecified date, the patient developed difficulty breathing after receiving both the influenza virus vaccine (unspecified) and Pneumovax 23.  It was noted by the reporter that when the patient received the flu vaccine alone (on two separate occasions in two different years), she developed difficulty breathing.  At the time of this report, the patient had recovered.  No product quality complaint was involved.  Additional information has been requested.				Y					Y				Unknown	OTH	OTH			Unknown		WAES0705USA00038	1						1	Condition aggravated; Dyspnoea; Vaccine positive rechallenge	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0286850	08/06/2007	MD				U		Discovered by a third nurse who removed an influenza vaccine syringe and then in double-checking the drug noticed the drug name on the syringe.														UNK	UNK						1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~HEP B (ENGERIX-B)~1	USA		Influenza
0282936	08/07/2007	CA	51.0	51		F	08/06/2007	This event was already reported to VAERS by the reporter VAERS ID: 282936 Female patient received the following vaccines prior to her trip: on 11/08/06 patient received Td, Fluzone, Hevrix (for Hep. A); on 11/15/06 patient received an oral typhoid vaccine Vivotif, manufactured by Berna Biotech Ltd (lot number unknown as the pharmacy discarded the box). Patient also received a generic version of Mefloquine Hydrochloride (drug against malaria) on 12/21/06. On 12/31/06 patient started experiencing difficulty swallowing (dysphagia), slurred speech, tongue twitching, and general fatigue. Patient still experiences these symptoms. There have been one time occurrence of other symptoms:01/18/07-patient experienced headaches in different areas of her head. Headaches dissipated. 01/25/07-patient's right cheek drooped for about 15 minutes and then returned to normal. 01/26/07-patient experienced numbness on the left side of the face, which eventually dissipated. 04/2007-patient had an episode where her left arm went numb for about 15 minutes. Patient had different tests done, which did not show anything. In April 2007 patient saw a neurologist and received a diagnosis of ALS. Patient was seeing an immunologist to test her sensitivity to mercury. Patient was not ill at the time of vaccination, was not taking any medications with exception of vitamins, and did not have any diagnosed allergies or medical conditions, although was noted to be sensitive to medications. Patient previously (in 1997) received a DT vaccination, as well as a Hepatitis A vaccination, and does not recollect experiencing any adverse reaction to either of the two vaccines. The reporter said that she already reported this event to VAERS (VAERS ID: 282936) and will report this event to manufacturers of other vaccines that patient received. At this point the event was assessed as unexpected by MPHBL medical staff, however the seriousness of the event could not be assessed without additional follow up information. The following follow up information was assessed as serious and unexpected Patient saw immunologist and completed extensive blood testing, which showed disregulation of the immune system and elevated mercury antibody levels. Reporter said that patient lives next to silver mines and probably throughout her life was constantly exposed to mercury, which collected in her blood and tissues. Reporter suggested that when patient received her vaccinations, the mercury level in patient's body was probably pushed over the limit. Patient is currently in Germany and is undergoing chelation therapy. Reporter described patient's current condition as improved and said that the full results on the therapy are usually seen in 3-6 months.				Y					U	11/08/2006	12/31/2006	53	Extensive blood testing showed disregulation of the immune system and elevated mercury antibody levels.	OTH	OTH	Vivotif, Mefloquine Hydrochloride	None	Sensitive to medications		AE0727	1						3	Amyotrophic lateral sclerosis; Asthenia; Balance disorder; Bulbar palsy; Coordination abnormal; Dysarthria; Dysphagia; Ear pain; Eye pain; Facial palsy; Fatigue; Headache; Hypoaesthesia facial; Immune system disorder; Laboratory test; Muscle twitching; Amyotrophic lateral sclerosis; Dysarthria; Dysphagia; Facial palsy; Fatigue; Headache; Vision blurred; Amyotrophic lateral sclerosis; Antibody test abnormal; Blood mercury abnormal; Blood test abnormal; Chelation therapy; Dysarthria; Dysphagia; Facial palsy; Fatigue; Headache; Hypoaesthesia; Hypoaesthesia facial; Immune system disorder; Metal poisoning; Tongue disorder	DT~MASS. PUB HLTH BIOL LAB~TD-162~UNK~IM~UN~DT ADSORBED (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U-2255AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB107AA~UNK~IM~UN~HEP A (HAVRIX)~1|FLU3~SANOFI PASTEUR~U2255AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB107AA~UNK~IM~~HEP A (HAVRIX)~2|TD~MASS. PUB HLTH BIOL LAB~TD162~UNK~IM~~TD ADSORBED (TDVAX)~2|TYP~BERNA BIOTECH, LTD.~~UNK~PO~MO~TYPHOID LIVE ORAL TY21A (VIVOTIF)~2|FLU3~SANOFI PASTEUR~U2255AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~3|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB107AA~UNK~IM~UN~HEP A (HAVRIX)~3|TD~MASS. PUB HLTH BIOL LAB~Td162~UNK~IM~UN~TD ADSORBED (TDVAX)~3	USA	Emergency room visit	Influenza
0284397	08/08/2007	OK	17.0	16		M	07/31/2007	Sinus infection - ipsorintic arteritis flare-up - extreme abdomen pain (ER), Let low on blood work - saw hematologist (DEC): developed pneumonia - 3 weeks constant round the clock suctioning, 3 rounds antibiotics and constant severe colon spasms require medicine (FEB), GI tests (MAR), exploratory bowel surgery and appendectomy for intussusception with ongoing constipation problem.			Y	Y	Y	6		Y	Y	11/01/2006	11/06/2006	5	Bldwork, X-Rays, CT San and with anesthesia, and Colonoscopy, Esophageal endoscopy (Hosp 24 hrs for), Ultrasound.	PVT	OTH	Tylenol, Zyrtec, Glycolax	No	IgA immunodeficiency (contraindicated); Down syndrome	autism poss from mercury prevention immunization~Vaccine not specified (no brand name)~~0.00~In Patient		1						2	Abdominal pain; Appendicectomy; Appendix disorder; Blood test abnormal; Colonoscopy; Computerised tomogram; Constipation; Contraindication to vaccination; Endoscopy; Hyperplasia; Inflammation; Intussusception; Intussusception; Irritable bowel syndrome; Laboratory test; Laparotomy; Lymphoid tissue hyperplasia; Platelet count decreased; Pneumonia; Psoriatic arthropathy; Selective IgA immunodeficiency; Sinusitis; Abdominal pain; Appendicectomy; Arteritis; Arthritis; Blood test; Colonoscopy; Computerised tomogram; Constipation; Endoscopy; Intussusception; Irritable bowel syndrome; Platelet count decreased; Pneumonia; Sinusitis; Surgery; Ultrasound abdomen; X-ray	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0287773	08/10/2007		46.0	46		F	08/10/2007	We received via Vaccine Information Service in the USA the following information on 30 JUL 2007: A 46-year-old woman, born on 13 NOV 1960, was vaccinated with Fluvirin, batch-no 70740, into the left arm on 17 NOV 2006. Since then, she has experienced severe pain at the injection site, and limited range of motion in her left arm. This has subsided somewhat over time, yet she does still experience pain upon extension of her arm. There is nothing visible at the injection site and the patient feels that the muscle in that area has been affected. Company assessment: Seriousness criterion: permanent disability. Causality: Insufficient data. Expectedness assessment according to SPC: The reported symptoms, except for pain at injection site, are not expected after vaccination with Fluvirin (due to the long duration). No change in benefit-risk-ratio. No measures necessary.								Y	N	11/17/2006	11/17/2006	0		OTH	OTH	No other medications	Unknown			MA20070767	1						1	Injected limb mobility decreased; Injection site pain; Injection site reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70740~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0287834	08/11/2007	HI	1.88	1	.9	M	08/11/2007	This INFLUENZA shot was the THIRD our son received in 2006.  He received two at Hospital in January AND February 2006.  He then received the influenza shot again in November 2006.  Since there was an unknown amount of thimerosol in these three flu shots, I am unable to report how much ethylmercury exposure patient received from the three shots.  Following this shot, patient's developmental delay worsened and he was diagnosed with autism in January 2007.   8/28/07 Received vax records from clinic which reveal that on 7/14/06 patient received only DTaP #4 & Hep A #2 (PPD lot # 28996).  (Also indicates patient received flu vax on 1/18/06, 2/22/06 & 11/7/06 for related report).  Medical records received for 6/05-8/07.  7/14/06 visit indicates well patient but no speech or communication w/family.  Referred for Speech & Audiology evaluation for delayed milestones.  Testing indicated  hearing WNL.  On 11/7/06 seen only for vax, no indication of medical status.  1/07 note indicates language & socialization issues.  1/07 seen for full developmental eval & Dx w/PDD & Autism including PICA.  8/07 Having heavy metal testing done & receiving developmental services. FINAL DX: Autism. Follow-up: Please send me any information on the amount of thimerosol contained in this vaccine. (Sorry for the late reply. I was deployed for 15 months.)								Y	U	11/07/2006	11/07/2006	0	We will be screening patient in one week for mercury levels in his blood.	MIL	MIL			PMH: Possible allergic reaction to dog licking face.  Recurrent otitis media, prolonged URI, viral exanthem, pharyngitis, cellulitis of diaper area, gastroenteritis, bronchitis, candidiasis, cerumen occlusion.			1						1	Autism; Blood mercury; Developmental delay; Social problem; Speech disorder developmental	FLU3~SANOFI PASTEUR~U2174GA~3~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0287886	08/13/2007	CA	16.0			F	08/10/2007	Information has been received from a physician's wife concerning a 16 year old female who in November 2006, was vaccinated with a first dose of Gardasil. Concomitant therapy included influenza virus vaccine (unspecified). Ten minutes after receiving the vaccination, the patient experienced a one minute seizure. The patient was sent to the emergency room and diagnosed with seizure disorder. Subsequently, the patient recovered from the seizure. She has since had a second and third dose of Gardasil and did not experience any seizure activities after those doses. Upon internal review, seizure disorder was considered to be an other important medical event. Additional information has been requested.				Y					Y	11/01/2006	11/01/2006	0	Unknown	OTH	OTH			None		WAES0708USA00707	1						1	Convulsion	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~1~UN~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0287903	08/13/2007	OK	54.0	54		F	02/08/2007	Severe headache - lasted to 2-6-07, pain right arm traveled to shoulder and elbow. Injection site red, swollen to armpit. Saturday unable to get out of bed 2-3-07. Sunday 2-4-07 - went to hospital, temp. 103, IV Benadryl. Issued Morphine and pain medication, temp. normal. Unable to move right arm until 2-7-07. March 1, 07 only complaint - muscle soreness in body.				Y					Y	02/02/2007	02/02/2007	0	EKG - abnormal; Stress test - negative	PUB	PUB	Celexa; Tramadol, Advair, Nexium, Darvocet	None	Allergic to sulfa; COPD; Carpal tunnel, Degenerative disc disease - neck, mitral valve prolapse.		OK0704	1						1	Body temperature increased; Cardiac stress test; Electrocardiogram abnormal; Headache; Injected limb mobility decreased; Injection site erythema; Injection site swelling; Myalgia; Pain in extremity	FLU3~SANOFI PASTEUR~U2262AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0287904	08/13/2007	OK	34.0	34		F	02/09/2007	State a few minutes after got MMR and Flu states burning sensation at shoulder and neck and back of neck felt stiff. After 15 minutes pt states burning is now just in shoulder of arm. Neck still a little stiff.									Y	02/09/2007	02/09/2007	0	Called at 4 PM. Patient doing fine.	PUB	PUB	Nuvaring	No	None		OK0702	1						1	Burning sensation; Musculoskeletal pain; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U2262AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~UNKNOWN MANUFACTURER~0094F~2~SC~RL~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1	USA		Influenza
0287906	08/13/2007	OK	66.0	66		M	12/01/2006	He states that his left arm swelled three times normal after receiving a flu shot. He states that it was so painful that he could not sleep that night. He saw PA the next day and was told it was an allergic reaction. His arm was warm to touch and swollen but not 3 times on 11/28/06				Y					Y	11/27/2006	11/27/2006	0	None	PUB	PUB	Unknown	None	Unknown		OK0627	1						1	Hypersensitivity; Oedema peripheral; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~U2262AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1008P~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0287952	08/13/2007	MD	42.0	41		M	08/13/2007	Nearly immediately following the vaccines dark circle, bags and and what is now a permanent tired line appeared under my eyes and spinal pain.  These side affects have worsened and show no indication of lessening.  Two additional vacciness not listed on your site that were administered were Menomune and Typhim.									N	12/20/2006	12/21/2006	1	Visit to doctor offered no options.	UNK	PVT						1						1	Back pain; Immediate post-injection reaction; Skin discolouration	FLUX~UNKNOWN MANUFACTURER~unknown~2~ID~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~unknown~2~ID~UN~HEP A (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~unknown~2~ID~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~unknown~2~ID~UN~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0288785	08/23/2007	MD		41		M	08/23/2007	This case was reported by a healthcare professional via a sales representative and described the occurrence of dark circles under eyes in an adult male subject who was vaccinated with Havrix, GlaxoSmithKline for prophylaxis. Concurrent vaccination included Salmonella typhi Vi capsular polysaccharide vaccine (manufacturer unspecified), inactivated poliomyelitis virus vaccine (Sanofi), influenza virus vaccine (manufacturer unspecified), meningococcal polysaccharide groups A, C, W and Y vaccine (Sanofi) and tetanus and diphtheria toxoids adsorbed (Sanofi) given on 20 December 2006. Concurrent medications included Valaciclovir hydrochloride (Valtrex). On 20 December 2006 the subject received 1st dose of Havrix at 1 ml in the right arm. At an unspecified time after vaccination with Havrix, the subject experienced dark circles under eyes, bags under eyes and blemish (described as a permanent tired line) on the face. At the time of reporting the events were unresolved. The healthcare professional stated that in the consumers opinion, the events were considered to be disabling.								Y	N	12/20/2006			UNK	PVT	PVT	Valaciclovir hydrochlorid	Unknown	The subject previously received a flu vaccine, but it was not known if the subject experienced any adverse reactions following vaccination.		A0673897A	1						1	Dark circles under eyes; Eye swelling	FLUX~UNKNOWN MANUFACTURER~AFLUA203BA~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB109CB~1~UN~RA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~Z0306~UNK~UN~UN~POLIO VIRUS, INACT. (IPOL)~1|MEN~SANOFI PASTEUR~UE966AA~UNK~UN~UN~MENINGOCOCCAL (MENOMUNE)~1|TD~SANOFI PASTEUR~U1880DA~UNK~UN~UN~TD ADSORBED (NO BRAND NAME)~1|TYP~SANOFI PASTEUR~Z0512~UNK~UN~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Disabling	Influenza
0288950	08/24/2007	VA	22.0	22		M	08/24/2007	massive headaches beginning in Feb99 which resolved sometime in 1999. Nite sweats beginning in July99 and resolved in Aug99; breathing problems beginning in Aug 99. 12/12/99 admitted to hospital for cough, fever.1/26/2000 admitted to NH for cough dx with eosinophilic pnuemonia 9/17/07-records received for DOS 12/22-12/24/99-admitted with 2 week history of fever, cough most lately with some hemoptysis, 10 pound weight loss. Shortness of breath, lungs clear. Impression:bilateral apical infiltrates, rule out tuberculosis, rule out atypical viral disease				Y	Y	2		Y	N	10/19/1998	02/01/1999	105	Feb 2000 lung bx showed eosinophilic infiltrate and lung thickening; pulmonary smears X4 (1/06) neg; stool cx (1/06) neg 9/17/07-records received-CXR: apical infiltrates bilaterally. White count 18000 with atypical lymphocytes. Blood culture no growth. Legionella none detected.	UNK	UNK			scoliosis			1						1	Biopsy lung abnormal; Cough; Culture stool negative; Dyspnoea; Eosinophilia; Eosinophilic pneumonia; Headache; Night sweats; Pyrexia	ANTH~UNKNOWN MANUFACTURER~FAV034~4~~~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0289090	08/27/2007	FL	60.0	60		F	08/21/2007	Employee states on 3/2007 noticed 2 small red indented marks to left deltoid area. Denied any pain, swelling or itching to site. State in June 2007 noticed some tissue loss to the area. No on 6/27/07 went to see a dermatologist but no treatment was given. Then on 7/24/07 returned to dermatologist due to continued changes in the tissue and had a skin biopsy done. Employee was then referred to an orth specialist who she saw on 8/1/07 and had an x-ray done. Result was area consistent with selective muscle atrophy secondary to vaccine injection (See notes enclosed from her doctors). She is to follow-up with doctor in 2 months.										10/09/2006	03/01/2007	143		OTH	PVT	None	None	None			1						1	Muscle atrophy	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70618~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0289271	08/29/2007	CA	31.0	31		F	08/24/2007	Initial report received 14 August 2007 from a health care professional. A 31-year-old female patient had received a prophylactic injection of Fluzone on 26 December 2006 during her second trimester of pregnancy. The patient's date of conception had been reported as 25 August 2006 with an estimated delivery date of 18 May 2007. Exposures reported during pregnancy included alcohol, passive smoke, caffeine, and mold in office. During her third trimester, beginning on 12 February 2007, she experienced a cough which lasted seven days, ending on 18 February 2007. Then, beginning 08 March 2007, she experienced a temperature of 100 degrees Fahrenheit, and bronchitis/cold symptoms. Her temperature returned to normal the following day but her bronchitis/cold symptoms persisted until 04 May 2007. She had been prescribed antibiotics NCS from 01 April 2007 until 30 April 2007 and Z-PAKs from 15 April 2007 to 04 May 2007. An ultrasound performed 02 May 2007 revealed low amniotic fluid and a non-stress test performed on 08 May 2007 had normal results. The patient had a c-section after diagnosis of oligohydramnics on 18 May 2007, her AFI was 2. The baby had cyanosis at birth which resolved within 2 hours. Shortly after birth the baby started having difficulties breathing and was diagnosed with pulmonary hypertension and intubated for 24 hours and the pulmonary hypertension resolved. Oxygen was administered another 24 hours and on 20 May 2007, the baby was breathing normally. The baby had been prescribed antibiotics for one week and all laboratory results were normal, negative for infection. The baby had been monitored for five additional days and had been released on 26 May 2007. This case was originally reported as non-serious, however, it was upgraded to serious by manufacturer. This case is linked to the baby's case 2007-02795 (pulmonary hypertension, jaundice).				Y					N	12/26/2006	02/12/2007	48	06/Jan/2007 and 30/Jan/2007 - ultrasound (normal); 16/Feb/2007 - Glucose tolerance test (0 - normal); 02/May/2007 - ultrasound (abnormal, low amniotic fluid); 08/May/2007 - Non-stress Test - (normal)	UNK	UNK	PRENATAL VITAMINS, TUMS, TYLENOL, TYLENOL COLD, MUCINEX, THERAFLU, DOCUSATE, ANTIBIOTIC, Z-PAK		The patient had exposure to alcohol, caffeine, passive smoke and mold during her pregnancy. The patient experienced cough from 12 February until 18 February 2007 and had received antibiotic therapy for a respiratory infection (bronchitis, cold, and fever) from 06 March 2007 until 04 May 2007, all prior to the birth of her baby. The patient also had a history of Meningitis occurring on three separate occasions during the following years: 1996, 1998, and 2000.		200702829	1						1	Body temperature increased; Bronchitis; Caesarean section; Cardiac stress test; Cough; Drug exposure during pregnancy; Foetal disorder; Glucose tolerance test normal; Nasopharyngitis; Oligohydramnios; Ultrasound abdomen abnormal	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0289272	08/29/2007	CA				M	08/23/2007	Initial report received 14 August 2007 from a health care professional. A male newborn baby had received a prophylactic dose of Fluzone transplacentally through maternal exposure during his second trimester of pregnancy on 26 December 2006. The baby was born and presented with jaundice at birth which resolved within 2-3 days requiring no treatment. The baby had cyanosis at birth which resolved within 2 hours after birth. Shortly after birth, the baby started having difficulties breathing, he was diagnosis with pulmonary hypertension and intubated for 24 hours. Baby was admitted to the NICU for four days for pulmonary hypertension. The pulmonary hypertension resolved within 24 hours; however resolved within 24 hours; however the baby was breathing normally and no longer required supplemental oxygen. He was given prophylactic antibiotics for one week and all laboratory results were normal, he was not positive for any infection. The baby was monitored for five additional days and released from the hospital on 26 May 2007. Per the reporter, the baby's mother had a c-section after diagnosis of oligohydramnics on 18 May 2007, her AFI was 2. Her date of conception had been reported as 25 August 2006 with an estimated delivery date of 18 May 2006. Maternal exposures reported during pregnancy included alcohol, passive smoke, caffeine, and mold in office. During her third trimester, from 08 March 2007 until 04 May 2007, she experienced bronchitis/cold symptoms which had been treated with antibiotics from 01 April 2007 to 04 May 2007. An ultrasound had been performed on 02 May 2007 which revealed low amniotic fluid. This case is linked to the mother's case 2007-02829 (Oligohydramnios).				Y	Y	9			Y	12/26/2006	05/18/2007	143	All labs normal, no presence of infection.	UNK	UNK			Maternal exposures include alcohol, caffeine, passive smoke and mold during pregnancy. The patient's mother experienced a cough from 12 February until 18 February 2007 and had received antibiotic therapy for a respiratory infection (bronchitis, cold, and fever) from 08 March 2007 until 04 May 2007, all prior to the patient's birth.		200702795	1						1	Caesarean section; Drug exposure during pregnancy; Foetal disorder; Laboratory test normal	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0289598	08/31/2007	LA	28.0			F		1. Flu vaccine 10/2/06. Developed fever 10/10/06, rash 10/12/06. C/O blurred vision, spots, halo effect 10/22/06. To ER with eye complaint 12/2/06.				Y					Y				Focal chorioretinitis, fecal retin ochoroiditis, large intraretinal infarct with edema right eye	PVT	PVT						1						1	Chorioretinitis; Halo vision; Pyrexia; Rash; Vision blurred	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA237AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0289690	09/04/2007	MO	66.0	66		F	08/30/2007	A 67-year-old female patient, with a history of atrial fibrillation, received an intramuscular right deltoid injection of Fluzone (lot number U2165CA) on 31 October 2006, at 1:30 pm. By 8:00 pm, the patient reported that her heart was racing. This continued for two days, and the patient called her primary care physician and was informed that it would subside. She subsequently travelled to visit her daughter, and while there experienced a heart attack (dates not provided). According to the patient, she was hospitalized for one week and underwent a full cardiac work-up; the events were considered to be resolved. Concomitant medications included Coumadin, Diovan, and Toprol XL.					Y	7			Y	10/31/2006	11/01/2006	1		PVT	PVT	COUMADIN, DIOVAN, TOPROL XL		Atrial fibrillation		200702860	1						1	Myocardial infarction; Palpitations	FLU3~SANOFI PASTEUR~U2165CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0289821	09/05/2007	PR	49.0	49		M	08/30/2007	Blood pressure - Lisinopril 20mg; Cholesterol - Simvastatin 40mg; Depression - Venlafaxine HCl 37.5 mg; Pain - Naproxen 550 mg.				Y						01/21/2004				MIL	MIL						1						1	Blood cholesterol; Depression; Hypertension; Pain	ANTH~UNKNOWN MANUFACTURER~~UNK~UN~UN~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0275138	09/10/2007		19.0			M	06/29/2007	Initial report received on 08 May 2007 from the Centers for Disease Control and Prevention. VAERS ID # 275138. A 19-year-old male patient, was vaccinated on 13 July 2006 with Poliomyelitis vaccine inactivated, Diphtheria and Tetanus Toxoids vaccine, and Yellow Fever vaccine. The tradenames, manufacturer's names, lot numbers, routes and sites of administration were not reported. The patient had also received Influenza vaccine, Menactra vaccine (lot number U2057AA), Hepatitis A (vaccine, Hepatitis B vaccine, MMR II and Pneumococcal vaccine on 13 June 2006 that are also considered suspect vaccines. The trade names, manufacturer's names, lot numbers, routes and sites of administration were not reported for any of these vaccines except the Menactra vaccine. Three days after receiving the vaccinations on 13 July 2006, the patient experienced numbness, tingling, and weakness in his calves, ankles and feet. This progressed to a diagnosis of GBS (Guillain-Barre syndrome). Treatments received and diagnostic tests performed were not reported. The recovery status of the patient was not reported. Follow-up information received on 27 June 2007 from the Centers for Disease Control and Prevention, VAERS# 27513B. Per the reporter, this case meets criteria for Guillain-Barre syndrome. No other relevant medical information was provided.				Y					N	06/13/2006	07/16/2006	33		UNK	UNK					200701591	1						2	Guillain-Barre syndrome; Hypoaesthesia; Muscular weakness; Neuropathy; Paraesthesia; Yellow fever; Asthenia; Guillain-Barre syndrome; Hypoaesthesia; Paraesthesia	HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB05ACA~2~~~HEP A + HEP B (TWINRIX)~1|IPV~SANOFI PASTEUR~Y8CA962~1~SC~~POLIO VIRUS, INACT. (IPOL)~1|MNQ~SANOFI PASTEUR~~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TD~SANOFI PASTEUR~C2457AA~1~~~TD ADSORBED (NO BRAND NAME)~1|YF~SANOFI PASTEUR~0383R~1~~~YELLOW FEVER (YF-VAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~2|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~2|IPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~2|MNQ~SANOFI PASTEUR~U2057A~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|YF~UNKNOWN MANUFACTURER~~UNK~UN~UN~YELLOW FEVER (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0290279	09/11/2007	PR	40.0	40		M	09/07/2007	Cramps, ache joins and muscles, anxiety, acne loss of concentration, depression, fatigue, rectal bleeding thinking abnormality, somnolence, vision blurred etc..				Y					N	11/01/2003			Skin rash-Acne, loss appetite, cramps	MIL	MIL						1						1	Acne; Anxiety; Arthralgia; Depression; Disturbance in attention; Fatigue; Muscle spasms; Myalgia; Rectal haemorrhage; Somnolence; Thinking abnormal; Vision blurred	ANTH~UNKNOWN MANUFACTURER~~4~UN~UN~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~3~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~5~UN~UN~HEP B (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~3~UN~UN~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0290508	09/13/2007	GA	13.0	13		M	09/13/2007	Hives and redness at injection site, within 5 minutes of vaccine given									Y	09/13/2007	09/13/2007	0	None	PVT	PVT	None	Well check	ADD			1						1	Immediate post-injection reaction; Injection site erythema; Injection site urticaria	FLU3~SANOFI PASTEUR~U2449AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U24181AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~07264~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0290511	09/13/2007	IL	19.0	19		M	06/18/2007	C/O difficulty breathing receiving Bicillin. Wheezing all lobes, Benadryl and Epi administered. IV Normal saline started. Transported to medical center via EMS.				Y					Y	06/11/2007	06/11/2007	0		MIL	MIL	None	None	None			1						1	Dyspnoea; Wheezing	FLU3~SANOFI PASTEUR~U2310AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~UNKNOWN MANUFACTURER~U2231A~1~IM~LA~MENINGOCOCCAL (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~1469F~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TDAP~SANOFI PASTEUR~C2690AA~1~IM~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0290640	09/14/2007	NJ	15.0	15		F	09/14/2007	Redness, Pain, and Heat below injection site - Left arm 4.5 x 5									U	09/12/2007	09/12/2007	0		PVT	PVT	none	none	none			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~12280AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2418AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0290662	09/17/2007	CA	83.0	83		M	09/13/2007	Initial report received on 23 April 2007 from an investigator participating in the above-mentioned trial in the United States under the reference number FIM05. An 83-year-old male subject developed myasthenia gravis approximately one month after he had received a first, intramuscular, left deltoid dose of study vaccine FLUZONE (lot number not reported), on 14 October 2006. The subject had relevant past medical history of fatigue (2005) and ocular hypertension. Sometime in November 2006, approximately one month post-vaccination, the subject began having bilateral facial weakness, difficulty swallowing both liquids and solids, and difficulty articulating his words. He was diagnosed with myasthenia gravis. The subject had a radiographic swallowing study that was normal. An MRI of the brain on 30 November 2006 showed normal brain with mild atrophic changes commensurate with age, thickening of the transverse ligament compatible with inflammatory arthropathies, and no flattening of the cervical medullary junction. On 02 December 2006 and MRI of the cervical spine showed diffuse degenerative disc and vertebral disease changes at the cervical spine with mild central stenosis involving C3-4 through C6-7 levels. There was multilevel asymetric foraminal narrowing and abundant pannus formation about the dens. An Esophagram on 15 December 2006 was normal. On 20 December 2006 EMG and nerve conduction studies showed abnormalities that were not specific for nerve, neuromuscular junction, or muscle disease. Diagnostic laboratory data on 02 January 2007 showed creatine kinase level of 36 (normal range 24-26), and elevated acetylcholine receptor antibody levels of 8.4 (normal range 0.00-0.24). On 18 January 2007, the subject was evaluated by neurology and started on Mestinon. A CAT scan of the chest was ordered along with thyroid panel, serum B12, methylmalonics acid, and ANA (results not reported). The subject continues to progress well and is being followed by neurology. The subject did not recovered, but has continued in the study trial. According to the investigator, the event of myasthenia gravis is related to the study vaccine, but not to the concomitant medications. Document held by sender: Neurology doctor notes, EMG and nerve conduction study results. Unblinding information received on 31 August 2007. The subject received Fluzone.				Y					N	10/14/2006	11/01/2006	18		UNK	UNK	NAPROXEN, FLOMAX, PROSCAR, NEXIUM, HALCION, BENICAR, DARVOCET N-100		The subject had relevant past medical history of fatigue (2005) and ocular hypertension.		200701361	1						1	Antinuclear antibody; Blood creatine phosphokinase increased; Computerised tomogram; Dysarthria; Dysphagia; Electromyogram abnormal; Facial paresis; Laboratory test; Laboratory test abnormal; Myasthenia gravis; Nerve conduction studies abnormal; Nuclear magnetic resonance imaging abnormal; Nuclear magnetic resonance imaging brain normal; Oesophagram; Thyroid function test; Vitamin B12	FLU3~SANOFI PASTEUR~UBBB~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0290664	09/17/2007	PA	37.0	37		F	09/12/2007	Initial serious report received from a health care professional on 31 August 2007. A 37-year-old female with a history of childhood asthma had received an intramuscular injection of Fluzone (Lot number U2436AA) to her left arm at 6:00 AM on 31 August 2007. At 9:45 AM that same day, the patient felt tightness in her chest and shortness of breath, described as, Like asthma attack. The patient had no illness at the time of vaccination and had not received any other vaccinations within four weeks prior to this event. It was reported that the patient was not taking any concomitant medications. Recovery status was reported as Recovered. No additional information has been provided at the time of this report.				Y					Y	08/31/2007	08/31/2007	0		UNK	UNK			The patient has a history of childhood asthma. Concomitant medications: None		200702997	1						1	Asthma; Chest discomfort; Dyspnoea	FLU3~SANOFI PASTEUR~U2436AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0290665	09/17/2007	PA	25.0	25		U	09/12/2007	This case was reported by a health professional on 31 August 2007. A 25-year-old patient with a history of migraine received an intramuscular left arm injection of Fluzone (U2436AA) on 30 August 2007 at 2:00pm. The patient had a mild headache at the time of injection, and after receiving Fluzone took Relpax to treat the headache. Three hours later, at 5:00pm, the patient noticed tense muscles, throat swelled, and difficulty drinking/eating. The events resolved. No additional information was provided.				Y					Y	08/30/2007	08/30/2007	0		UNK	UNK	RELPAX	Mild headache at the time of vaccination.	History of migraine.		200703009	1						1	Dysphagia; Muscle tightness; Pharyngeal oedema	FLU3~SANOFI PASTEUR~U2436AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0290681	09/17/2007		37.0	37		F	09/18/2007	A report was received from a healthcare professional on 23/Oct/2006 concerning a 37 year old female vaccinee. No details were provided regarding the vaccinee's medical history or concomitant medications. On 13/Oct/2006 the vaccinee received Fluvirin 0.5ml. Two days later the vaccinee experienced severe muscle aches and joint pain which was ongoing at the time of reporting. Further information will be requested. Addendum: We received additional information on 05 SEP 2007: A 37-year old woman, born on 18 FEB 1969, was vaccinated with 1.0 ml Fluvirin, batch-no. 69427, i.m. on 13 OCT 2006. Multiple paresthesia and pain in arms less than legs, blurred vision and trouble walking were reported on 13 OCT 2006. The patient has not yet recovered at the time of report (05 MAR 2007).					Y	0		Y	N	10/13/2006	10/15/2006	2		OTH	OTH		Unknown	1993 APPENDECTOMY, 1994/1995 COLITIS		CVOX200600294	1						1	Arthralgia; Gait disturbance; Myalgia; Pain in extremity; Paraesthesia; Vision blurred	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69427~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0290696	09/17/2007	IN	38.0	38		F	09/13/2007	Redness at injection site for flu shot and PPD-No induration.									U	09/11/2007	09/12/2007	1	None	PVT	PVT	Allegra, PPD	None	Seasonal Hay Fever			1						1	Injection site erythema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78479~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0267494	09/18/2007	PA	28.0	27		M	08/21/2007	10/06/2006 Headache, fever 102 saw medic before leaving work. Saw doctor had chest X-ray. Put on active coughing, tired, weakness. 10/07/2006 vomiting worse, cough, feeling worse, still temp elevation 10/08/2006 very short of breathing, chest pain, very weak, ache all over. Kept feeling worse. 10/20 Heart block - on respirator. Now have pacemaker.			Y	Y	Y	0	Y	Y	N	10/05/2006	10/06/2006	1	Hospital 4/13 many X-rays, Blood tests, Ct scans, MRI, EKG, Echocardiogram, Heart cath	MIL	OTH	None	None	Allergic Penicillin/ None			1						5	Atrioventricular block complete; Haemoptysis; Hypoxia; Lung infiltration; Myocarditis; Rash; Vaccination complication; Vasculitis; Asthenia; Atrioventricular block; Blood test; Body temperature increased; Catheterisation cardiac; Chest X-ray; Chest pain; Computerised tomogram; Cough; Dyspnoea; Echocardiogram; Electrocardiogram; Fatigue; Headache; Nuclear magnetic resonance imaging; Pain; Pyrexia; Vomiting; X-ray	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~4|FLUN3~MEDIMMUNE VACCINES, INC.~500430P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~5	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0290790	09/18/2007	CA	70.0	70		F	09/18/2007	Left deltoid with swelling, redness, hot. Pt c/o pain to site Rx Keflex 500 mg QID x 7 days.									Y	09/17/2007	09/17/2007	0	None	PVT	PVT		None	Hypertension			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79241~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0038U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0290833	09/18/2007	CA	8.0	8		F	09/18/2007	PATIENT CAME IN 9/13/07 FOR 8YR PE AND VACCINES.  NO RECENT OR CURRENT ILLNESS AT THE TIME.  DURING ADMINISTRATION OF VACCINES, PATIENT APPARENTLY STRUGGLED AND MOVED. THE FOLLOWING DAY, PATIENT DEVELOPED REDNESS AND SWELLING OF THE RIGHT ARM AT THE VACCINE SITE.  PATIENT WAS SEEN IN DOCTOR'S OFFICE FOR F/U ON 9/17/07 AND MOM STATED THAT REACTION SITE WAS IMPROVING.  UPON EXAM, RIGHT MID DELTOID HAD APPROX. 4 CM OF REDNESS, WITH SOME SWELLING AND TENDERNES.  MOM WAS INSTRUCTED TO PROVIDE SUPPORTIVE CARE AND TO F/U WITHIN 3 DAYS IF NO IMPROVEMENT SEEN.				Y					Y	09/13/2007	09/14/2007	1		PVT	PVT	NONE	NONE				1						1	Injection site erythema; Injection site swelling; Tenderness	FLU3~SANOFI PASTEUR~U2449AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0304U~2~IM~LA~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~1024U~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0290963	09/20/2007	FL	1.6			F		Fever 102 9/12 to 9/14. Papular rash throughout body 9/15 - 9/18. 9/19 rash improving but not sore.											09/12/2007		High monocytes (1027); normal white blood cell count; nl allergy panel	PVT	UNK		None	None			1						1	Allergy test negative; Monocyte count increased; Pyrexia; Rash generalised; Rash papular; White blood cell count normal	FLU3~SANOFI PASTEUR~UF2456BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0290964	09/20/2007	VA	1.0	1	.0	M	09/14/2007	MMR, Varivax, Hepatitis A, and Fluzone given on 9/4/07. 9/14/07 awoke with rash on torso, neck and face - blotchy, papular. 1 tsp Benadryl given.				Y					U	09/04/2007	09/14/2007	10		PVT	PVT	None	None	None			1						1	Rash; Rash macular; Rash papular	FLU3~SANOFI PASTEUR~UT2456CA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB181AA~1~IM~RA~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0282U~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0848U~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0290978	09/20/2007	FL	38.0	38		F	09/20/2007	Painful swelling with erythema and 6 cm induration at injection site.									U	09/19/2007	09/19/2007	0	n/a	UNK	PVT	Synthroid 137 mcg po qd	None	hypothyroidism			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79488~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0291116	09/21/2007	CA	1.4	1	.4	F	09/19/2007	Febrile seizure, probable vaccine related. Tonic convulsion by postictal limping. Tylenol and cooling measures done at home, temperatures from 102.6 - 103.9.									Y	09/18/2007	09/19/2007	1	Develop Delay/Periventicular leukomalacia	PVT	PVT		Well child	Develop delay/periventricular leukomalecia			1						1	Body temperature increased; Cardiac disorder; Developmental delay; Febrile convulsion; Gait disturbance; Immunisation reaction; Postictal state; Tonic convulsion	FLU3~SANOFI PASTEUR~UT2456AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0257U~2~IM~UN~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~C35168~2~IM~UN~PNEUMO (PREVNAR)~1	USA		Influenza
0291104	09/23/2007	SC	1.33	1	.3	M	09/23/2007	2 hours after the flu vaccine was administered my son began getting hives. The hives were all over his body-red, raised,itchy whelps. The hives went away when Aveeno ant-itch cream was administered but new hives cont. to pop-up in different places. The peditrician's office was contacted, they did not associate the hives with the vaccine and told me to give him children's liquid Benadryl. The hives improved with Benadryl but have cont. to reoccur for over 1 week. My son is to see his Pediatrican again in 2 days.				Y					U	09/14/2007	09/14/2007	0	none at this time	UNK	UNK	pt. also taking an Albuterol inhaler for acute wheexing-the pt. had not taken the inhaler for >24 hours of the adverse event	mild chest cold				1						1	Erythema; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0291164	09/24/2007	PA	9.0	9		F	09/21/2007	Information has been received from a physician concerning a 9 year old female who on 13-SEP-2007 was vaccinated with a dose of VAQTA. Suspect vaccination administered that day included a dose of VARIVAX and a dose of FLUZONE. On 14-SEP-2007 the patient was diagnosed with encephalitis characterized by headache, dizziness, stumbling, memory changes, and confusion. The patient was also noted to have mild facial palsy. The patient was seen by the physician and was subsequently hospitalized. The patient was not recovered. There was no product quality complaint. The physician also considered encephalitis and mild facial palsy to be disabling. Additional information has been requested. 10/8/07-records received-for DOS 9/15-9/21/07-DC DX: left basal ganglia infarct. Presented with 2 day history of severe headaches. Noted to have right sided facial droop with confusion. Poor handwriting and slurred speech as well as ataxia with right arm weakness.  Headaches began on day she received vaccines. Ocular disks were only partially visualized. Discharged to rehab. Per 60 day follow up: S/p left cannulate/basal ganglia stroke. Patient has Rt facial palsy (mild), Rt side hemiparesis with spasiticty rt foot, aquired attention deficit disorder iwht impulsive disorder and speech dysfunction. Conditions requires frequent speech therapy, OT and PT as well as behavioral psychological therapy.				Y	Y	6		Y	N	09/13/2007	09/15/2007	2	Unknown records received 10/8/07-CT scan of head showed hypodensity of caudate in basal ganglia region concerning for possible infarct. MRI showed abnormal signals coming from left caudate nucleus and most of globus pallidus plus part of deep temporal ocular gyrus. MRA of neck normal and MRV of brain normal. EEG showed asymmetry of two side of brain with slowing on left side. CT angiography of head showed narrowing and irregularity of proximal left middle cerebral artery and edema of left basal ganglia. Cerebral angiogram showed a beaded appearance of proximal left middle cerebral proximal ACA suggesting vasculopathy. 2D echo trace right to left shunting and possible patent foramen ovale. . Possible hypercoagulopathy with PTG 34.2 all the way to 20.6 second both represent high and low of average. Normal protein C, protein S and antithrombin III levels. Triglycerides of 376 and fasting of 522.	OTH	OTH	Unknown		Unknown records received 10/8/07-HX of headaches prior for approximately 6 months.		WAES0709USA02231	1						1	Confusional state; Dizziness; Encephalitis; Facial palsy; Gait disturbance; Headache; Hemiparesis; Memory impairment; Cerebrovascular accident; Confusional state; Disorientation; Dysarthria; Dysgraphia; Facial palsy; Headache; Hemiparesis; Nuclear magnetic resonance imaging brain abnormal; Pain; Rash papular; Scan brain; Confusional state; Dizziness; Encephalitis; Facial palsy; Gait disturbance; Headache; Memory impairment	FLU3~SANOFI PASTEUR~U2446AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0800U~UNK~UN~UN~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~0125U~UNK~UN~UN~VARICELLA (VARIVAX)~1|FLU3~SANOFI PASTEUR~U2446AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~MERCK & CO. INC.~0800U~1~IM~LA~HEP A (VAQTA)~2|VARCEL~MERCK & CO. INC.~0125U~2~SC~LA~VARICELLA (VARIVAX)~2|FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~3|HEPA~MERCK & CO. INC.~~UNK~UN~UN~HEP A (VAQTA)~3|VARCEL~MERCK & CO. INC.~~UNK~UN~UN~VARICELLA (VARIVAX)~3	USA	Hospitalisation,Disabling	Influenza
0291210	09/24/2007	AL	4.0	4		M	09/24/2007	Fever started 10/21/07, vomited once, fever 103.8 on 10/22/07 - sore throat, hoarse, faint, pink rash around neck and cheeks.				Y						09/20/2007	09/21/2007	1	Rapid strep - neg; Hospital outpt.. lab throat culture - preliminary - no pathogens	PVT	PVT						1						1	Culture throat; Dysphonia; Pharyngolaryngeal pain; Pyrexia; Rash; Streptococcal identification test; Syncope; Vomiting	DTAP~SANOFI PASTEUR~U2156AA~5~UN~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2440AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z1009~4~UN~RA~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0291218	09/24/2007	VA	2.0	2	.5	F	09/18/2007	Pt seen in our office with 6-7 pustular round pruritic lesions on (L) abdomen									Y	01/03/2005	09/18/2007	988		PVT	PUB						1						1	Pruritus; Rash pustular; Skin lesion	DTAP~SANOFI PASTEUR~U1290AB~4~UN~UN~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U1468AA~3~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE238AA~1~UN~UN~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~X0146~3~UN~UN~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1143N~1~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0291303	09/25/2007	MT	0.6	0	.6	M	09/13/2007	Fever of 100 to 103 persistent since evening of vaccine. Because Mom's described lethargy not relieved by antipyretics went to ER next morning. ER dx OM, Rx'd Abx. Fevers gone by 9/15/07. Small lump at shot site 9-25-07.				Y					Y	09/11/2007	09/11/2007	0		PVT	PVT		URI/Pharyngitis	Atopic Dermatitis; RAD; Omnicef			1						1	Drug hypersensitivity; Injection site mass; Lethargy; Otitis media; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21b127AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2456BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0072U~3~IM~LL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B53981E~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0291318	09/25/2007	UT	0.6	0	.6	M	09/19/2007	Seizure 2 days after vaccine.				Y					Y	01/02/2007	01/03/2007	1	nl MRI/EEG	PVT	PVT	None	No	Motor delay			1						1	Convulsion; Electroencephalogram normal; Nuclear magnetic resonance imaging normal	DTAP~SANOFI PASTEUR~C2407AA~3~UN~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2252AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0237F~2~UN~RL~HIB + HEP B (COMVAX)~1|IPV~SANOFI PASTEUR~Y1030~3~UN~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~B08657A~3~UN~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0291164	09/26/2007	PA	9.0	9		F	09/21/2007	Immunizations given 9/13 7:13 pm. Pt developed marked headache over several hours in the evening. Pt appeared normal in morning and went to school. Pt became symptomatic in school with disorientation, slurred speech, pain writing. Pt was seen in doctor office midday and had confusion, rt papuled area, rt facial palsy, and rt sided weakness. Pt immediately sent to medical center for stat CT brain scan and transport to another hospital. Pt was diagnosed with stroke, etiology not yet determined. MRA abnormal. Eventually pt to be transferred to another facility for rehab therapy.			Y	Y	Y	0	Y		N	09/13/2007	09/13/2007	0		PVT	PVT	None	Joint pain - mild	Learning disability, cleft palate repair about age 5. Pt was adopted; medical history unknown.			1						2	Confusional state; Dizziness; Encephalitis; Facial palsy; Gait disturbance; Headache; Hemiparesis; Memory impairment; Cerebrovascular accident; Confusional state; Disorientation; Dysarthria; Dysgraphia; Facial palsy; Headache; Hemiparesis; Nuclear magnetic resonance imaging brain abnormal; Pain; Rash papular; Scan brain; Confusional state; Dizziness; Encephalitis; Facial palsy; Gait disturbance; Headache; Memory impairment	FLU3~SANOFI PASTEUR~U2446AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0800U~UNK~UN~UN~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~0125U~UNK~UN~UN~VARICELLA (VARIVAX)~1|FLU3~SANOFI PASTEUR~U2446AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~MERCK & CO. INC.~0800U~1~IM~LA~HEP A (VAQTA)~2|VARCEL~MERCK & CO. INC.~0125U~2~SC~LA~VARICELLA (VARIVAX)~2|FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~3|HEPA~MERCK & CO. INC.~~UNK~UN~UN~HEP A (VAQTA)~3|VARCEL~MERCK & CO. INC.~~UNK~UN~UN~VARICELLA (VARIVAX)~3	USA	Life Threatening,Hospitalisation	Influenza
0291391	09/26/2007		20.0			F	09/26/2007	This case was reported by a healthcare professional, via a sales representative, and described the occurrence of Stevens Johnson syndrome in a female subject aged between 20 and 29 years old who was vaccinated with Flu vaccine, manufacturer unspecified) for prophylaxis. Co-suspect medication included Lamotrigine (Lamictal). On an unspecified date the subject received unspecified dose of Flu vaccine (unknown). In 2006, at an unspecified time after vaccination with Flu vaccine, the subject experienced Stevens Johnson syndrome, organ failure, flu-like symptoms, and fever. The subject was hospitalized. The subject died from Stevens Johnson syndrome. An autopsy was performed. The patient developed flu-like symptoms but had just been given the flu vaccine. She then spiked a fever of 106 degrees and was hospitalized. Lamictal was not discontinued because the providers were originally associating the events with the flu vaccine. The patient went into organ failure and was placed in the intensive care unit and then died. The autopsy results indicated that the patient died of Stevens Johnson syndrome which might have been caused by Lamictal use.   10/2/07 Received patient demographics from FDA.  10/5/07 Reviewed MD medical records which reveal patient made emergency visit on 11/30/2006 3 days s/p flu shot at unknown facility.  Day after flu shot, developed severely high fever, shaking & chills follwed by SOB, chest discomfort & decreased urine output over past couple of days.  Had started Lamictal 14 days prior.  Temp in office 107 via ear by MD.  Face & chest were red & patient considered extremely toxic w/shaking chills, cracked dry lips, dry mucous membranes.  MD called ambulance & sent to ER.  Also called pts psychiatrist. MD FINAL DX: malignant hyperthermia, unclear etiology.  possible reaction to flu vaccine, possible drug reaction to Lamictal or possible Stevens Johnson syndrome. possible reaction to psychiatric medication. 10/19/07 Received autopsy report which states COD as complication of probable drug hypersensitivity syndrome due to Lamictal therapy for treatment of bipolar disorder & manner of death as therapeutic complication.  Final Dx: I.  Probable drug hypersensitivity syndrome.    A. recent initiation (approx 7-10 days prior to clinical presentation) of Lamictal therapy for treatment of bipolar disorder.    B. hospital admission 11/30/06 in acute distress, febrile w/generalized rash & facial & lip swelling.    C. progressive deterioration w/multi-organ system failure.    D. S/P attempted resuscitation.    E.  scattered petechiae of head, torso & extremities    F. diffuse alveolar damage of lungs    G. centrizonal hepatic nectosis    H. multifocal infarcts of spleen.    I. autolysis of stomach & pancreas.    J. focal ischemic changes of small & large intestine. II. Cardiac enlargement. 12/14/07 Reviewed hospital medical records which reveal patient experienced fever, chills & facial rash.  Tx empirically for UTI w/IV antibiotics.  DX: anticonvulsant hypersensitivity syndrome, renal failure & progressive ARDS.  To ICU on vent.  Continued fever spikes, DIC & generalized body rash.  Tx w/antihistamine & steroids w/some rash improvement.  Pulmonary failure progressed & developed bilat pleural effusions.  Emergent bronchoscopy done & bilat chest tubes placed.  Continued to deteriorate w/progressive acidosis, cardiomyopathy & ischemic bowel.  Coded & expired. FINAL HOSPITAL DX: anticonvulsant hypersensitivity reaciton; DIC; ischemic bowel; cardiomyopathy; renal failure; ARDS; fungemia; pulmonary failure; hx of bipolar disease.	Y	12/11/2006			Y	12			N				UNK MD office LABS: EKG sinus tachycardia.  pulse ox unable to register. Hospital LABS: Blood cultures (+) for fungemia.	OTH	OTH		Unknown	PMH: mood disorder & depression.		A0683361A	1						1	Autopsy; Death; Influenza like illness; Intensive care; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0291402	09/26/2007	TX	68.0	68		M		Patient had redness and swelling at injection site. Area was about 4 inches by about 2 1/2 inches. Right arm									U	09/23/2007	09/24/2007	1	None	OTH	PVT		None	None			1						1	Injection site erythema; Injection site swelling; Wrong drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79238~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARZOS~MERCK & CO. INC.~1406F~1~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0291501	09/27/2007	NY	18.0	18		F	09/26/2007	Patient became lightheaded after Gardasil and Flu vaccinations, BP lying down was 137/90, pulse 70, after 15 minutes, BP 132/88, patient c/o headache. Patient stated she felt better, after sitting up initially, BP 133/89, pulse 64, final BP 128/86. Pediatric vaccine information sheets given									U	09/25/2007	09/25/2007	0		PVT	PVT			Asthma			1						1	Dizziness; Headache	FLU3~SANOFI PASTEUR~U2436AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1062U~3~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0291511	09/27/2007	FL	45.0	45		F	09/27/2007	Intense itch and exaserbation of scar tissue from poison oak contracted in 2004 on the right forearm, distal from the vaccin,  arm heavy and small fluid filled blisters are noteed on the arm, some have been broken due to scratching.  Also generalized aching, some tachycardia  up to 24 + hours after injection.  Skin on arm is red and there is also generalized itching,  No respriatory symptoms.  Applied cortizone otc cream 12 hours after injection, upon waking with the intense itching.  This reactin is similar to a reaction seen on this patient upon recieving PPD injection...the skin gets red but not endurated.  Also, pt took 50 mg of benadryl at hs the night of the injection (Approx. 7 hours after).									Y	09/26/2007	09/27/2007	1		PUB	UNK	Zoloft 100mg PO QD, Synthroid .005 mg, Alieve otc 220 mg po bid, Calcium 600 mg + vit D one tab po qd, Activella, one po qd,					1						1	Condition aggravated; Erythema; Pain; Pruritus; Rash vesicular; Sensation of heaviness; Tachycardia	FLU3~SANOFI PASTEUR~u2444aa~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0291516	09/27/2007	TX	47.0	47		F	09/27/2007	Patient had a recent hx of intestinal N/V, no fever, and was better.  She received the Flu shot at 8:45 a.m.  She was fine then around 10:00 she had some nausea, then vomited, and then started to shiver.  she is also diabetic and her blood sugar was 68.  She drank some Coke and rechecked blood sugar and it was 91, her Temp was 100.2 and continuing to shiver.  Adminstered Acetaminophen 325 mg 2 tabs and gave her some saltine crackers to eat to raise her blod sugar.  Her temp reached 101.3.  By 11:00 the shivering had stopped, her temp was 99.2, and her blood sugar was 159.									Y	09/27/2007	09/27/2007	0		UNK	PUB	Humalog, Lantus Insulins	Had a hx of recent intestinal nausea and vomiting	Diabetic			1						1	Body temperature increased; Chills; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U2489AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0291518	09/27/2007	LA	29.0	29		F	09/27/2007	15 minutes post injection c/o feeling hot, itching to trunk and hands, tightness in chest area				Y					Y	09/26/2007	09/26/2007	0	Oxygen saturation was 97% on room air.  No other diagnostic tests done	PVT	PVT	Singular	None	Allergy induced Asthma			1						1	Chest discomfort; Feeling hot; Oxygen saturation normal; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78479~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0291600	09/28/2007	NJ	8.0			F	09/21/2007	Seen 9/19/07 for 8 year old WCV received flu vaccine woke up 9/20/07 with red, swollen, hot arm at injection site. Diagnosed with Cellulitis treated with Keflex.				Y					Y					PVT	UNK						1						1	Cellulitis; Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2437AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0291649	09/28/2007	MA	73.0	73		F	09/28/2007	Redness, Swelling, Itching at injection site immidiately after injection that lasted 3-4 days. Tongue swelling that started 2 days after vaccine administered and lasted 1-2 days.									Y	09/21/2007	09/21/2007	0		PVT	PUB	Atenolol, Allegra, xanax, Plavix, celexa abilify, spiriva, firoranal	No	Htn, smoker, hypoglycemia, copd, Fibromystosis			1						1	Immediate post-injection reaction; Injection site erythema; Injection site pruritus; Injection site swelling; Swollen tongue	FLU3~SANOFI PASTEUR~U2448AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0291650	09/28/2007	TX	17.0	17		F	09/28/2007	Patient is experiencing trembling in the upper torsal 2 hours after given the fluvirin vaccine.  Patient is experiencing some chills and cold.									U	09/28/2007	09/28/2007	0		UNK	PVT		None	None			1						1	Chills; Feeling cold; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79238~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0296055	09/28/2007	MN				F	09/18/2007	This case was reported by a consumer and described the occurrence of unspecified event in an adult female subject who was vaccinated with influenza virus vaccine (Flu vaccine, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. On 31 October 2006 the subject received unspecified dose of Flu vaccine at 0.5 ml with an expiration date of 30 June 2007. In the first week of November 2006, at an unspecified time after vaccination with Flu vaccine, the subject developed problems (not specified). At the time of reporting the event was unresolved. No additional information is expected.									N	10/31/2006	11/01/2006	1	UNK	OTH	MIL		Unknown	The subject received a flu vaccine (unspecified) in 2005 and she did not experience any reactions.		A0664091A	1						1	Adverse event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0281700	10/01/2007	DC	33.0	33		M	09/26/2007	Description: Developed weakness in lower extremities and SOB, and pain in hips and back after AVA, Flu, Hep A-B. Sxs began 4 ds after vaccination and remains hospitalized. Symptom: Cough, dry Symptom: Dyspnea Symptom: Joint Pain, multiple joints Symptoms: Fever 17 Sep 07 Although sxs resolved in 7/07, they have again flared.				Y	Y				U	06/05/2007	07/07/2007	32	See Attached- spirometry showed 60% partial obstruction. Not improved with bronchodilators. Labs: See attached	MIL	MIL	None	None	None			1						2	Blood bilirubin increased; Blood gases abnormal; Blood immunoglobulin G; Blood immunoglobulin M; Chest X-ray normal; Chest discomfort; Chills; Cough; Dyspnoea; Dyspnoea; Electrocardiogram normal; Hot flush; Lymphocyte count decreased; Pain; Productive cough; Urine analysis normal; Wheezing; White blood cell count increased; Arthralgia; Back pain; Cough; Dyspnoea; Muscular weakness; Pyrexia; Spirometry abnormal	ANTH~EMERGENT BIOSOLUTIONS~FAV105~1~IM~LA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U2308AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB094AA~UNK~IM~RA~HEP A + HEP B (TWINRIX)~1|ANTH~UNKNOWN MANUFACTURER~~1~SC~~ANTHRAX (NO BRAND NAME)~2|FLUX~UNKNOWN MANUFACTURER~~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEPAB~UNKNOWN MANUFACTURER~~3~~~HEP A + HEP B (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0291678	10/01/2007	CT	1.5	1	.5	M	10/01/2007	Healthy 18 mo male with history of febrile seizure in 3/07 given MMR II, VZV, DTaP & Flu vaccine on 9/24/07. Child discovered by mother deceased in bed approx 9/25/07.  11/30/07 Reviewed autopsy report which states COD as undetermined & manner of death undetermined.  Anatomic diagnoses: pulmonary congestion & edema, sudden of unknown etiology.  Patient was found unresponsive face down on mattress in crib.	Y	09/25/2007							N	09/24/2007	09/25/2007	1		PVT	PVT	None	None	Febrile seizure 3/07 - nl EEG  5/07	mild febrile rxn~Vaccine not specified (no brand name)~UN~0.00~In Patient		1						1	Death	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B056CA~4~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2456BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0700F~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0823U~1~SC~RA~VARICELLA (VARIVAX)~1|MMR~MERCK & CO. INC.~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~2|VARCEL~MERCK & CO. INC.~~UNK~UN~UN~VARICELLA (VARIVAX)~2	USA	Results in Death	Influenza
0291697	10/01/2007	PR	38.0	38		M	09/28/2007	Allerg react - blood pressure high - blood - high cholesterol - memory difficulty - memory loss - pain back - rash - infection with rash - sleep problems 10/8/07-records received-Referred to psychiartry for nightmares. Treated in clinic for DX of essential hypertension. Obesity. Tobacco use. Hyperlipidemia. PTSD.  Alcohol dependence.			Y						N	02/15/2003				MIL	MIL			High blood pressure			1						1	Amnesia; Back pain; Blood cholesterol increased; Hypersensitivity; Hypertension; Infection; Memory impairment; Rash; Sleep disorder	ANTH~EMERGENT BIOSOLUTIONS~FAV072~UNK~UN~UN~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U0983AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~HEP B (ENGERIX-B)~1|HEPA~MERCK & CO. INC.~0032N~UNK~UN~UN~HEP A (VAQTA)~1	USA	Life Threatening	Influenza
0291700	10/01/2007	MI	53.0	53		F	10/01/2007	Patient c/o fever, body aches and lt arm was swollen with knot, red and warm to the touch.									Y	09/28/2007	09/29/2007	1	n/a	PVT	PVT		none				1						1	Erythema; Mass; Oedema peripheral; Pain; Pyrexia; Skin warm	FLU3~SANOFI PASTEUR~u2467aa~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~c2824aa~UNK~IM~~TDAP (ADACEL)~1	USA		Influenza
0291704	10/01/2007	CO	5.0	5		M	10/01/2007	Note:  patient immunocompromised s/p heart transplant.  Developed inflammation/?myositis in both legs; refused to move them.  Admitted, given iv antibiotics x48 hours, then oral abx.  Recovered uneventfully.  10/15/2007 MR received from PCP. Vax record included and lot numbers updated in VAERS database. Pt in for WCC and vax on 9/17/2007.  Seen again 9/19/07 for fever, decreased po intake, diarrhea, and won't move body since 9/17/07. (+) bladder incontinence because of refusal to get up.  PE (+) for refusal to move and generalized tenderness of the lower extremities.  Admited to hospital for presumed myositis.    01/14/2008 MR received for DOS 9/19-22/2007 with D/C DX:  Myositis.  Child presented for direct admit for c/o fever, pain and refusal to walk.    PE (+) for tenderness from the L hip to knee.  Red streaking noted on 9/20/07.  Txd with abx with good result.  Pt became hyperkalemic during admit with EKG changes which resolved with IVF changes and kayexolate.  D/C on po abx.				Y	Y	4			Y	09/17/2007	09/17/2007	0	Labs and Diagnostics: X-ray LLE  WNL.. MRI  with abnormal signal in the L vastus intermedius, biceps femoris, and SubQ tissue.  No osteomyelitis or abscess noted.   Sed rate 74.  CRP 11.5, down to 2.4 on 9/22/07. CK 7.  Blood culture (+) for GPC in groups 9presumed contaminant). Repeat BCx (-). CBC with WBC 6.0 on admission then low WBC, RBC, Hct, Hgb throughout admsission.	UNK	UNK	neoral, cellecept, enalapril, aspirin, zithromax	no acute illness	hypoplastic left heart s/p transplant, polysplenia syndrome, malrotation s/p repair. PMH: Hypoplastic L Heart Syndrome s/p heart transplant & thymectomy (8/02).  2 episodes of rejection.  Polysplenia Syndrome.  Interrupted IVC with azygous continuation.  Coarct of Aorta-repaired 2/03.  Allergic Colitis. Circumcision.  Nickel dermatitis. ? eczema.  Physiologic anisocoria R>L.  Night terrors.  Leg pain-myalgias.  Surgery for malrotation 8/30/07:Ladds Procedure.			1						1	Infection in an immunocompromised host; Inflammation; Movement disorder; Myositis	DTAP~SANOFI PASTEUR~C2605AA~UNK~~~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2443AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0304U~UNK~~~HEP A (VAQTA)~1|IPV~UNKNOWN MANUFACTURER~Z0547~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0002F~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0291706	10/01/2007	TX	59.0	59		M	10/01/2007	States that 2 hours after receiving pneumococcal vaccine, his right arm became red & swollen at the injection site.  State that he took Tylenol & used a heating pad for relief.  States that redness & discomfort lasted about 48 hours, then all symptoms resolved.									Y	09/26/2007	09/26/2007	0	none	PUB	PUB		none	history of heart attack			1						1	Discomfort; Injection site erythema; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80060~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0888F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0291714	10/01/2007	NM	63.0	63		F	10/01/2007	Half dollar sized erythematous area around injection site.									U	09/26/2007	10/01/2007	5		UNK	PVT		None	None			1						1	Injection site erythema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~9897~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0991u~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~0887U~UNK~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0291732	10/01/2007	NV	58.0	58		F	09/25/2007	Sick on 9-18-07. Woke up with every muscle in my body hurting. I was so weak that going to the bathroom was difficult. At the site where the shot was given - red and hot the size of a silver dollar. On 9-20-07 the red started to travel down my arm. (Ibuprofen)									Y	09/17/2007	09/18/2007	1	None - went to Dr. on 9-20-07	PUB	OTH	Green Tea; Glucosamine Chondroitin; Calcium +D; B Complex; E, Magnesium;; L-Lysine; Fish Oil, Omega 3 Fatty Acids; Multi-Vitamin; Femora; Amitriptyline; Maxalt	None	Allergies: erythromycin, Iodine, and Latex			1						1	Asthenia; Injection site erythema; Injection site warmth; Myalgia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78476~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0993U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0291743	10/01/2007	LA	25.0	25		F	10/01/2007	Itching, red patchy rash onset-Approx 2 hours after inj. Resolved 30 min after injection of Adrenalin 0.2 ml				Y					Y	10/01/2007	10/01/2007	0	Allergic reaction to Flulaval	PVT	PVT	Cymbalta x 3 month OCF x 20 months	None	None			1						1	Erythema; Hypersensitivity; Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~GSKAFLLA031AA~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0291744	10/01/2007	WA	84.0	84		F	09/28/2007	Fever at least up to 2 days after injection. Redness of upper arm, not at injection site. Arm is sore and inflamed.									U	09/26/2007	09/28/2007	2	N/A	OTH	PUB			None			1						1	Erythema; Inflammation; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U2453AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0959E~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0291746	10/01/2007	WA	77.0	77		F	10/01/2007	Pt got bruise at the site of injection on Saturday (she got the shot on Friday) - but she came in Monday.									U	09/28/2007	09/29/2007	1		OTH	UNK						1						1	Injection site bruising	FLU3~SANOFI PASTEUR~U2453AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0291747	10/01/2007	MN	0.5	0	.5	F	10/01/2007	Rash - appeared within 5 minutes of vaccine face and neck. No wheezing. Resolved in 25 minutes with PO Benadryl (given immediately after onset of rash).									Y	10/01/2007	10/01/2007	0	None	PVT	UNK		Stuffiness - 2 wks	No			1						1	Rash	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B133AA~3~UN~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2459RA~UNK~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B54007D~3~UN~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1152U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0291775	10/01/2007	MI	6.0	6		F	09/28/2007	The pt. was given adult Hep A. No adverse reactions were reported.									Y	09/25/2007				PVT	PVT	Melatonin; Remeron; Adderall; Zoloft	None	ADHD; Fructose Intolerance			1						1	Wrong drug administered	FLU3~SANOFI PASTEUR~U2487~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB115CA~1~IM~RL~HEP A (HAVRIX)~1	USA		Influenza
0291846	10/02/2007	NY	1.3	1	.3	F	09/27/2007	Woke up from afternoon nap on 9/20/07 with hive and rash on torso and extremities. Was given Benadryl x 2 doses - hives subsided after 2nd dose.									Y	09/19/2007	09/20/2007	1		PVT	PVT	None	None	None			1						1	Rash; Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14b56DA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2444AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0257U~3~IM~LL~HIB (PEDVAXHIB)~1	USA		Influenza
0291849	10/02/2007	NY	84.0	84		F	09/27/2007	Pain at site, fever, vomiting, itching skin.									Y	09/20/2007	09/20/2007	0	None	PVT	PVT		None	Codeine			1						1	Injection site pain; Pruritus; Pyrexia; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79717~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1035F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0291855	10/02/2007	CA	57.0	57		F	10/02/2007	Lightheadedness, dizziness, fast heartbeat, nervousness, shaking, confusion										09/29/2007	09/29/2007	0		UNK	PVT			Neurontin, Pentasa			1						1	Confusional state; Dizziness; Heart rate increased; Nervousness; Tremor	FLU3~SANOFI PASTEUR~U2453AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0291857	10/02/2007	NE	35.0	35		F	10/02/2007	Severe dizziness soon after the shot was administered, the shot was administered was given approximately 10:30 a.m. I am going to see my neurologist. I have epilepsy and so thinking maybe it was something with that but now realized it could have been with the shot. This is my second day and still having dizziness.									U	10/01/2007	10/01/2007	0		PUB	UNK	Tegretol and Keppra	none	Epilepsy			1						1	Dizziness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80433~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0291860	10/02/2007	OH	0.5	0	.5	M	10/02/2007	within 6 hours of getting rototeq, flu, pneumonia and Hib vaccines, my son developed very bad diarrhea. He had 10-14 dirty diapers a day. This lasted about 7 days. He then spiked temps 6 days after receiving the vaccinations. His temp was up to 104. Went to the doctors office and they could not tell me what was causing this reaction. He also had terrible diaper rash that required special cream to start to heal. On day 9 after the vaccinations he was all better.				Y					Y	09/22/2007	09/22/2007	0	none	PVT	UNK	none	none	none			1						1	Body temperature increased; Dermatitis diaper; Diarrhoea; Inappropriate schedule of drug administration	FLUX~UNKNOWN MANUFACTURER~?~1~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HBHEPB~MERCK & CO. INC.~?~3~IM~UN~HIB + HEP B (COMVAX)~1|PPV~MERCK & CO. INC.~?~1~IM~UN~PNEUMO (PNEUMOVAX)~1|RV5~MERCK & CO. INC.~?~1~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0291896	10/02/2007	WY	61.0	61		F	10/02/2007	Hot to touch. Swollen raised 1/4 inch area 2 1/2-3 around.									Y	09/28/2007	10/01/2007	3	N/A	PVT	OTH		None				1						1	Skin warm; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA037AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0291943	10/03/2007	NC	24.0	24		F	10/03/2007	Hives on chest and swelling and redness on left arm. Present about 6 hrs after administration. Pt self treated with Benadryl.									Y	09/29/2007	09/29/2007	0	None	OTH	OTH	No, Orthotricyclen	Heel spur	Pen Allergic, Biaxin Allergy, Codeine Allergy			1						1	Erythema; Oedema peripheral; Urticaria	FLU3~SANOFI PASTEUR~L2501AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0291984	10/03/2007	IL	1.3	1	.3	M	10/03/2007	Pt was shaking and screaming at 5AM day after injection. Lasted 5 min. A second episode happened. Went to ER. Blood work done. T 101.5 and rash before going to ER.				Y					Y	10/02/2007	10/03/2007	1		PVT	PVT	None	None	None			1						1	Body temperature increased; Rash; Screaming; Tremor	DTAP~SANOFI PASTEUR~C2655AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2456CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~O0166~3~IM~LL~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~B539818~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0291989	10/03/2007	MA	56.0	56		F		Temp 102, chills lasting 12 hrs, muscle and joint pain throughout body lasting 24 hrs. Very painful. Numbness around mouth. Took total of 2 grams Tylenol and Benadryl 25mg.									Y	10/01/2007	10/01/2007	0	None	UNK	UNK	None	None	Unknown			1						1	Arthralgia; Body temperature increased; Chills; Hypoaesthesia oral; Myalgia; Pain	FLU3~SANOFI PASTEUR~U2457GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0291990	10/03/2007	KY	85.0	85		F	10/03/2007	I started to give injection and realized I did not get the air out of the prefilled syringe. I stopped and pulled it back out. But I had injected a little bit of it. The area was a little puffy and dark. I took later to see Dr's nurse and she said it was okay to just use some ice on it today.				Y					Y	10/03/2007	10/03/2007	0	None	PUB	PUB	Zocor, Amaryl, Zantac, Diovan HCT, Klonopin, Prilosec, Avandia, Valium, Meclizine, Coumadin	None				1						1	Wrong technique in drug usage process	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA303BA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0291994	10/03/2007	WI	21.0	21		F	10/03/2007	Pt had hives for 3 days 5 mo ago. Moved from another state. Had flu shot on 9/28/07. Five hours later had hives. Continues with breakouts through today 10/3/07. Not sure of environmental or from immunization.										09/28/2007	09/28/2007	0		PVT	OTH	Depo shot monthly	None	None known			1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79718~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0292004	10/03/2007	FL	47.0	46		F	10/03/2007	10/03/07 Client return to Clinic 10 at aproximately 11:20 am. She reports that she developed redness, swelling and pain to her arm about 4 hours after she was vaccinated with the influenza and pneumococcal vaccines.She states that she had pain and swelling to arm and had applied ice pack for most of the night with minimal relief. Client presented with redness, swelling and complain of pain, arm warm to touch with noted induration to left upper arm where she received the pneumococcal vaccine 0.5mL dose subcutaneously. Treatment pending, referred to physician.										10/02/2007	10/02/2007	0		PUB	PUB			Denies known allergies. Medical condition not disclosed at time of vaccination.			1						1	Erythema; Injection site erythema; Injection site induration; Injection site pain; Injection site swelling; Injection site warmth; Pain in extremity	FLU3~SANOFI PASTEUR~U2440AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0038U~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0292005	10/03/2007	MI	55.0	56		F	10/03/2007	Fever 101.7, chills, nausea									Y	10/01/2007	10/01/2007	0		PVT	PUB						1						1	Chills; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~u2469aa~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0292008	10/03/2007	CA	5.0	5		M	10/03/2007	PT GOT IMMUNIZATION 2 DAYS AGO AND STARTED HAVING SWELLING OF DELTOID AND ARM AREAS THE SAME DAY WITH ALSO REDNESS, HOT AND MILD PRURITUS.  HE WAS SEEN IN OFFICE TODAY 10/03/07 AND GIVEN BENADRYL.									U	10/01/2007	10/01/2007	0	NONE	PVT	PVT						1						1	Erythema; Oedema peripheral; Pruritus; Skin warm	FLU3~SANOFI PASTEUR~42461AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0292016	10/03/2007	TX	32.0	32		F	10/03/2007	vaccine admin. at 3:55, at 4:25 patient returned with hives over various areas of the body, at 4:35 administered 50mg diphenhydramine liq per Dr.'s order, rash reduced by 4:55 PM									Y	10/03/2007	10/03/2007	0	n/a	UNK	UNK						1						1	Rash; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua305aa~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0292139	10/04/2007	OH	76.0	76		F	10/01/2007	Seven days after Flu vaccine, ascending pain and paralysis occurred up to mid-face. Inability to swallow, breath and function. Six days out, went into respiratory failure, EMG and spinal tap confirmed Guillain Barre Syndrome. *Plasma Pheresis- trtmt at least 95%. 10/17/07-records received for DOS 11/26-1/5/07-DX: Guillain-Barre syndrome. Initially presented to transferring facility on 11/21/06- with C/O paresthesia of hand and lower extremities up to her knees. Sunday prior to admission was suddenly unable to walk. Recently had hip surgery. Flu shot prior to surgery in early 11/2006. Progessively weakened and developed respiratory failure requiring intubation, ventilation and tracheostomy and PEG were inserted. Eventually weaned off of CPAP. Problems with abdominal pain and reflux and nausea. Abdominal laparoscopy revealed a dislocated hip replacement and hip arthroplasty was performed. Transferred for rehab.			Y	Y	Y	42		Y	Y	11/12/2006	11/19/2006	7	EMG and Spinal Tap to confirm GBS from allergic reaction to flu shot.	PUB	OTH		Rt hip replacement surgery	Allergic to sulfa records received 10/17/07-PMH: high blood pressure. High cholesterol. Chronic back pain. Thrombocytopenia. Recent osteoarthritis			1						1	Dysphagia; Dyspnoea; Electromyogram abnormal; Guillain-Barre syndrome; Hypersensitivity; Lumbar puncture; Pain; Paralysis; Respiratory failure	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601711~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0292147	10/04/2007	MI	1.5	1	.5	F	10/03/2007	No symptoms-pt have for well child physical									Y	10/02/2007				PVT	PVT	None	None				1						1	No adverse reaction	FLU3~SANOFI PASTEUR~U2501AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB175AA~2~IM~LL~HEP A (HAVRIX)~1	USA		Influenza
0292149	10/04/2007	IL	82.0	82		F	09/24/2007	patient developed shingles in same arm as influenza vaccine 3 days after vaccine				Y					N	09/20/2007			None	PVT	PVT		None				1						1	Herpes zoster	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA033AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0292167	10/04/2007	FL	48.0	48		F	10/04/2007	Client return to clinic on 10/04/07. Complain of pain and swelling. Stated pain to arm started about 1 hour after shots. Noted Redness, swelling warm to touch and induration to left upper arm site where she received vaccines      3 days. No treatment initiated.										10/01/2007	10/02/2007	1		PUB	PUB						1						1	Erythema; Injection site induration; Injection site swelling; Injection site warmth; Oedema peripheral; Pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2440AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0038U~UNK~SC~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0292168	10/04/2007	PA	48.0	48		F	10/04/2007	Patient received influenza vaccine at work (employee at hospital) in the morning of 10/1/07.  Later that evening, around bedtime, patient developed nausea and vomiting.  Patient states she is only 55% better by 10/4/07.									Y	10/01/2007	10/01/2007	0	N/A	UNK	UNK	Unknown	no	Latex allergy (urticaria, dermatitis)			1						1	Nausea; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80685~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0292169	10/04/2007	NY	24.0	24		F	10/04/2007	Dizziness, Sweating, Tingling in fingers Onset was approximately 35 minutes after administration Effect was transient lasting 1-2 hrs. No treatment needed									Y	10/03/2007	10/03/2007	0	None	PUB	PVT		none	none			1						1	Dizziness; Paraesthesia; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79897~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0292171	10/04/2007	NY	28.0	28		F	10/04/2007	Dizziness, Sweating, Tingling in fingers. Onset was approximately 35-40 minutes after administration. Effect was transient lasting 1-2 hrs. No treatment needed									Y	10/03/2007	10/03/2007	0	None	PUB	PVT		none	none			1						1	Dizziness; Hyperhidrosis; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79897~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0292172	10/04/2007	ME	79.0	79		F	10/04/2007	Erythema, warmth, swelling, tenderness, and induration at injection site. Left arm.									U	10/03/2007	10/03/2007	0		PVT	UNK		None				1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0292176	10/04/2007	NY	34.0	34		F	10/04/2007	Sweating, Dizziness Onset was approximatelly 35 minutes after administration Effect was transient 1-2 hrs. No treatment needed									Y	10/03/2007	10/03/2007	0	none	PUB	PVT		none	unknown			1						1	Dizziness; Hyperhidrosis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79897~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0292177	10/04/2007	KY	72.0	72		F	10/04/2007	PATIENT CALLED PHARMACY THURSDAY MORNING COMPLANING OF LEFT ARM PAIN THAT BEGAN TUESDAY NIGHT AFTER RECEIVING FLU VACCINE TUES MORNING AROUND 11:30.  PAIN WORSENED BY WEDNESDAY NIGHT AND PATIENT COULD NOT SLEEP.  PATIENT STATES PAIN IS CONSTANT AND RADIATES DOWN LEFT ARM TO HAND AND IN LEFT SHOULDER BLADE.  PAIN HAS NOT SUBSIDED AS OF TODAY AND WILL BE SEEING HER PRIMARY CARE PHYSICIAN TODAY AT 2:30PM.  PATIENT HAS TRIED TAKING TYLENOL AS WELL AS USING AN ICE PACK FOR THE PAIN.  NOTHING HAS HELPED RELIEVE HER PAIN.  SUSPECT POSSIBLE NERVE DAMAGE DUE TO VACCINE ADMINISTRATION.				Y					U	10/02/2007	10/02/2007	0		UNK	PUB	ZETIA, GABAPENTIN, PIROXICAM, FEXOFENDINE, TRIAMTERENE/HCTZ, CELEBREX	NONE	DRUG ALLERGIES:  PCN, QUINOLONES			1						1	Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA30388~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0292178	10/04/2007	PA	73.0	69		F	10/04/2007	V received both the flu and pneumonia vaccines on 10/3.  She received the pneumonia vaccine in the right arm.  Later that night, she began experiencing headaches, body aches, and nasal congestion.  The patients daughter stated that her eyes are red and her right arm is red and swollen.									U	10/03/2007	10/03/2007	0		UNK	PUB	Unknown	None				1						1	Headache; Nasal congestion; Ocular hyperaemia; Oedema peripheral; Pain; Chills; Eye pruritus; Headache; Injection site erythema; Injection site pain; Injection site swelling; Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~42492AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0803U~2~IM~RA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~~UNK~UN~RA~PNEUMO (NO BRAND NAME)~2	USA		Influenza
0292181	10/04/2007	NY	28.0	28		F	10/04/2007	Complained of sweating, dizziness Onset approximatelly 35 minutes after administration of the shot. Effect was transient 1-2 hours. No treatment was required									Y	10/03/2007	10/03/2007	0	none	MIL	PVT		None stated	None stated			1						1	Dizziness; Hyperhidrosis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79897~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0292184	10/04/2007	NY	29.0	29		F	10/04/2007	Sweating, dizziness									Y	10/03/2007	10/03/2007	0	none	PUB	PVT		none stated	none stated			1						1	Dizziness; Hyperhidrosis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79897~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0292201	10/04/2007	AL	73.0	73		F	10/04/2007	Per patient she began feeling weak and hot and she had pain in the back of her neck.  Her hands were also shaking.  She tried taking one Tylenol and going to bed but she woke up at 4 AM and the symptoms continued.  She then went to the ER at 5 AM.  Approximately 24 hours later she continues to feel weak.				Y					N	10/03/2007	10/03/2007	0	Pt states blood work and heart tests were done in the ER	UNK	PVT	Synthroid, Pt also received a Decadron shot approximately 1 week prior to vaccination	None	Hypothyroid, Hay fever			1						1	Asthenia; Blood test; Cardiac monitoring; Neck pain; Skin warm; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA303BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0292208	10/04/2007	NY	7.0	7		M	10/04/2007	Large swelling of Right lower eyelid, apparently with clear fluid. No erythema. No respiratory symptoms-within 15 minutes of shots given 0.4 Epi IM (1:1000) and 40 mg Benadryl p.o. swelling decreased over PM. Observed in ED over 4 hours				Y					Y	10/03/2007	10/03/2007	0		UNK	UNK		None	Asthma, Pierre-Robin (S/P Cleft palate repair)			1						1	Eyelid oedema	FLU3~SANOFI PASTEUR~U2476HA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1268u~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0292209	10/04/2007	CA	81.0	81		F	10/02/2007	Swelling in her (R) UE x 2 weeks Pt's arm still hurts swelling down to her hand									N	09/20/2007	10/02/2007	12	None	PVT	UNK		None	None			1						1	Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2441AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TTOX~SANOFI PASTEUR~U1987AA~UNK~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~0884U~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0291164	10/05/2007		9.0	9		F	10/02/2007	This case was received from another manufacturer on 25 September 2007, under manufacturer control number WAES 0709USA02231. The following narrative is verbatim from the report:Information has been received from a physician concerning a 9 year old female who on 13-SEP-2007 was vaccinated with a dose of hepatitis A vaccine (inactive). Suspect vaccination administered that day included a dose of Varivax and a dose of Fluzone. On 14-SEP-2007 the patient was diagnosed with encephalitis characterized by headache, dizziness, stumbling, memory changes, and confusion. The patient was also noted to have mild facial palsy. The patient was seen by the physician and was subsequently hospitalized. The patient was not recovered. There was no product quality complaint. The physician also considered encephalitis and mild facial palsy to be disabling. Additional information has been requested.					Y			Y	N	09/13/2007	09/14/2007	1	Unknown	UNK	UNK			Unknown		200703233	1						3	Confusional state; Dizziness; Encephalitis; Facial palsy; Gait disturbance; Headache; Hemiparesis; Memory impairment; Cerebrovascular accident; Confusional state; Disorientation; Dysarthria; Dysgraphia; Facial palsy; Headache; Hemiparesis; Nuclear magnetic resonance imaging brain abnormal; Pain; Rash papular; Scan brain; Confusional state; Dizziness; Encephalitis; Facial palsy; Gait disturbance; Headache; Memory impairment	FLU3~SANOFI PASTEUR~U2446AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0800U~UNK~UN~UN~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~0125U~UNK~UN~UN~VARICELLA (VARIVAX)~1|FLU3~SANOFI PASTEUR~U2446AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~MERCK & CO. INC.~0800U~1~IM~LA~HEP A (VAQTA)~2|VARCEL~MERCK & CO. INC.~0125U~2~SC~LA~VARICELLA (VARIVAX)~2|FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~3|HEPA~MERCK & CO. INC.~~UNK~UN~UN~HEP A (VAQTA)~3|VARCEL~MERCK & CO. INC.~~UNK~UN~UN~VARICELLA (VARIVAX)~3	USA	Hospitalisation,Disabling	Influenza
0292273	10/05/2007	FL	43.0	43		F	09/28/2007	Nursing Comments: approximately 5 minutes after receiving 1st flu shot injection started to have a metallic taste in mouth, about 2 minutes later started to feel flushed, layed pt back on table and applied ice pack, about 2 minutes later, started to c/o dry mouth and that tongue felt like it was hanging on the back of her throat, received v/o to give pt 50 mg Benadryl po, given pt benadry at 1235 p.m at 12:40 pt complains of throat feeling full, states it feels funny pt complains of numbness around lips, Dr. listened to lungs and looked in throat, order received to given Decadron 4 mg, given Decadron 4mg IM right deltoid at 1245 states numbness around lips wearing off, pt coughing occasionally, speaking clearly, states I feel weird 12:57 Dr came in to assess and listen to lungs, instructions given to pt that is she has trouble breathing to go hospital right away, pt agreeable. pt d/c'd home at 1:02 p.m.									Y	09/28/2007	09/28/2007	0		PVT	PVT	Plaquenil 200 mg QD Effexor XR 75 mg QD	None	Systemic Lupus Erythematosus			1						1	Cough; Dry mouth; Dysgeusia; Dyspnoea; Feeling abnormal; Flushing; Hypoaesthesia oral; Paraesthesia oral; Throat tightness	FLU3~SANOFI PASTEUR~U2439AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0292274	10/05/2007	FL	66.0	66		F	10/01/2007	Approx. 5 mins. after receiving injection (pt was lying) she sat up and felt a sharp pain on left side of Torso (same side of injection), lasting a few seconds.									Y	10/01/2007	10/01/2007	0		PVT	UNK		None	Hyperlipidemia			1						1	Flank pain	FLU3~SANOFI PASTEUR~U2439AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0292302	10/05/2007	FL	37.0	37		F	10/05/2007	On Tuesday, 10/2/2007 I received an influenza vaccine. In the evening of the same day I began to experience wheezing, chest pain/pressure, shortness of breath, coughing and fatigue. I called my doctor who recommended Benadryl of which I took. I went back to see him today, 10/5/2007 and he said that I was wheezing and prescribed Albuterol inhaler and rest for the next several days.				Y					N	10/02/2007	10/02/2007	0	Chest x ray negative for infection	PVT	PVT	Entocort EC 4 days prior to influenza vaccine	None	Asthma, Crohn's disease			1						1	Chest X-ray normal; Chest discomfort; Chest pain; Cough; Dyspnoea; Fatigue; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0292303	10/05/2007	MA	25.0	25		F	10/05/2007	Pt presented 24 hours post vaccination. Pt c/o nodule at vaccine site with erythema 3 cm in diameter. Site was warm to the touch. Pt also c/o shouler arthralgia times 24 hours. Sx resolved completely over 48 hours. Pt denies N/V/D, fever, chills, malaise. Pt is 9 weeks pregnant. No previous hx of adverse reaction to immunizations.									Y	10/02/2007	10/03/2007	1	N/A	MIL	MIL	N/A	None	N/A			1						1	Arthralgia; Drug exposure during pregnancy; Injection site erythema; Injection site nodule; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA040AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0292306	10/05/2007	GA	26.0	26		F	10/05/2007	AROUND 9PM BOTH ARMS FELT HEAVY AND WEAK. WOKE UP AT 11:30PM ENTIRE UPPER BODY WAS HURTING AND ACHING. HAD MODERATE TO SEVERE PAIN IN THE CHEST AND HURT WHEN TAKEN BREATH. THIS WENT ON FOR ABOUT2 HOURS. TOOK TYENOLAT 1:30A. EVERTHING CONTINUE TO HURT ALONG WITH UNCONTROLLABLE SHAKING. FELT BETTERAROUND 3:30A									Y	10/04/2007	10/04/2007	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Chest pain; Muscular weakness; Pain; Sensation of heaviness; Tremor	FLU3~SANOFI PASTEUR~U2448AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0292308	10/05/2007	TN	42.0	42		F	10/05/2007	severe localized reaction at vaccine site not resolved after 7 days.  Patient was given combination steriod injection and told to return in one week.  Employee who administered injection SQ instead of IM has been counseled.									N	09/29/2007	09/30/2007	1		PVT	PVT						1						1	Incorrect route of drug administration; Injection site reaction; Local reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA033AA~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|MNQ~SANOFI PASTEUR~U23918BA~1~SC~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0292325	10/05/2007	WA	50.0	50		F	09/12/2007	No adverse rxn at time of administration. On 12/5/05 pt called to report pain and tingling in left arm. Pt seen in clinic 12/7/05 and given rx for pain.  10/9/07 Received vax record from pcp which confirms lot #. 10/19/07 Reviewed neurology medical records of 4/11/07 which reveal patient experienced pain in left arm x 18 mos s/p flu shot  FINAL DX: radial neuropathy.								Y	N	11/23/2005	11/28/2005	5	EMG/C-Spine MRI; Neurology consultation with doctor. Pt seems to have low grade radial neuropathy - NL EMG. LABS: EEG 9/06 WNL.  MRI of c-spine showed mild disc protrusion C5-6.  EMG of LUE was WNL.	PVT	PVT	Keppra; Neurontin; Hydrogamine; Darvon; Thyroid	None Known	Seizure d/o; IBS; Hypothyroidism; Raynaud's; Osteoporosis PMH: nocturnal epilepsy, last seizure 7/06.  RA, gynecomastia, cervical radiculopathy. Allergy: ASA, steoids, novocain, latex.			1						1	Electromyogram normal; Neuropathy; Pain in extremity; Paraesthesia	FLU3~SANOFI PASTEUR~U1904AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0292328	10/05/2007	CA				U		Nausea, feeling cold, perspiring, hot, weak, didn't feel like to do anything.									N	10/03/2007	10/03/2007	0		PUB	PVT		None	None			1						1	Asthenia; Feeling cold; Feeling hot; Hyperhidrosis; Nausea	FLU3~SANOFI PASTEUR~U2498AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0292330	10/05/2007	KY	68.0	68		F	10/05/2007	10/03/07 approximately 2:15pm vaccination with Pneumovax and Fluzone approximately 1030pm chills at bedtime. 10/4/07 (AM) Itching: skin inflammation; skin warm to touch. 10/5/07 (approximately 12N) - Symptoms remain. Patient will take Benadryl 25mg, PRN.									U	10/03/2007	10/03/2007	0		OTH	PVT	Cymbalta 30mg, Axipher 20mg, Metoprolol SR 25mg, Simvastin 40, Thipropenen SR 150	None				1						1	Chills; Inflammation; Pruritus; Skin warm	FLU3~SANOFI PASTEUR~U2499AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0962U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0292331	10/05/2007	CA		52		M	10/05/2007	High fever, cold, chills, stomach spasms, perspiring.									N	10/03/2007	10/03/2007	0		PUB	PVT	Protonix, Benicar HCT	None	None			1						1	Chills; Hyperhidrosis; Muscle spasms; Nasopharyngitis; Pyrexia	FLU3~SANOFI PASTEUR~U2498AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~2~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0292332	10/05/2007	DE	22.0	22		F	10/05/2007	Pt complained of arm pain, warmth in area site of injection, fatigue, and problems with motility of arm of injection site									U	10/02/2007	10/03/2007	1	None	OTH	OTH		None	None			1						1	Fatigue; Injection site movement impairment; Injection site warmth; Pain in extremity	FLU3~SANOFI PASTEUR~4250AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0038U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0292336	10/05/2007	CA	5.0	4		F	10/05/2007	Received DTaP and IPV in R deltoid.  Patient had tactile fever and pain on day of vaccine (10/2/07) and then had 1 1/2 day history of redness, warmth below injection site.  No fever.Pt had 11 x 11 cm red warm non-tender area below injection site.  Injection site not warm, not tender, not red and not swollen.  Pt treated with cephalexin 400 mg bid x 7 days.									U	10/02/2007	10/04/2007	2		PVT	PVT		no	no			1						1	Erythema; Pyrexia; Skin warm	DTAP~SANOFI PASTEUR~C2657AA~5~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2457EA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A1069~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0292347	10/05/2007	CO	83.0	83		F	10/05/2007	Patient received flu shot on 10/02/2007. Patient came to pharmacy today (10/05/2007) to show pharmacy intern her left upper arm where flu shot was administered.  Patient's upper left arm was noted by pharmacy intern to be substantially bruised being purple and black in color.  The bruising was noted to be circular and estimated to be about 3 inches in diameter and located towards the distal part of the deltoid muscle.  Apparently the bruising has lessened, but was more extensive starting that night that she received the flu shot, extending from where it is now to all the way to where the flu shot was administered.  Patient stated that her upper left arm was painful to move that night, but experienced no other symptoms.  Today patient did not complain of any symptoms, nor pain associated with the current bruising.  Patient stated that this never happened with previous flu shots.  Patient stated that she is not on Coumadin, but is taking aspirin.  Patient was advised that bruising is seen in some patients and that she should monitor the bruised area and seek medical attention if bruising gets worse or does not go away.									Y	10/02/2007	10/02/2007	0	Not applicable	PUB	PVT	Aspirin	None known	None known			1						1	Contusion; Pain in extremity	FLU3~SANOFI PASTEUR~U2488AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0292349	10/05/2007	UT	1.5	1	.5	F	10/05/2007	8CM ERYTHEMA ON RIGHT THIGH. HOT TO TOUCH. IF INCREASES GREATER THAN 1/2 INCH, START AUGMENTIN.				Y					U	10/03/2007	10/05/2007	2	N/A	UNK	UNK	N/A	DIAPER RASH	N/A			1						1	Erythema; Skin warm	DTAP~SANOFI PASTEUR~C2657AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2456DA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0292351	10/05/2007	FL	42.0	42		F	10/05/2007	joint pain especially in hands, difficulty bending fingers, joint pain extending down to knees, sever headaches.									U	10/01/2007	10/01/2007	0		PUB	UNK		none known	pcn, ceclor			1						1	Arthralgia; Headache	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0292369	10/05/2007	MI	48.0	48		F	10/03/2007	Painful injection site for 3 days. Can't sleep. Going to doctor today. Doctor told her that shot probably hit a tendon or ligament and gave her some pain pills to use at night.				Y					U	09/29/2007	09/29/2007	0	None Known	OTH	PVT		None	None			1						1	Injection site pain; Sleep disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA294EA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0292370	10/05/2007	IL	49.0	49		M	10/06/2007	Swelling of underside of right arm none at site. Warm to touch. Headache per patient.										10/03/2007	10/06/2007	3		OTH	UNK		None				1						1	Headache; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~2989AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0292378	10/05/2007	WA	76.0	76		M	10/05/2007	Within several hours of receiving the vaccine patient got a extremely sore arm with pain in the neck and back. Pain so severe in right arm. Patient is unable to move his arm.									N	10/02/2007	10/02/2007	0	None	PVT	PVT	None	None	Atrial fibrillation, Mitral regurgitation, Hypercholesteremia, BPH, Gastroesophageal reflux			1						1	Back pain; Injected limb mobility decreased; Neck pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80434~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0889F~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0292352	10/06/2007	AZ	55.0	55		M	10/06/2007	Migraine like headache, within 8 hours of administration.									Y	10/05/2007	10/05/2007	0		UNK	UNK						1						1	Migraine	FLU3~GLAXOSMITHKLINE BIOLOGICALS~unk manu/lot #~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0292354	10/06/2007	WA	59.0	59		F	10/06/2007	SEVERE PAIN INVOLVING ENTIRE DELTOID MUSCLE INTO WHICH PNEUMO VAC. WAS ADMINISTERED BEGINNING 5 HOURS AFTER IMMUNIZATION.  FEVER BUILDING TO 102 AT 24 HOURS; FEVER GONE AFTER 50 HOURS.  IMPROVEMENT IN MUSCLE PAIN AFTER 48 HOURS, BUT REDNESS AND SWELLING VISIBLE IN SPOTS EXTENDING FROM INJECTION SITE DOWN TO A 5X 8 AREA IN THE LOWER PART OF THE MUSCLE.  TEATED WITH TYLENOL AND ALLEVE.				Y					U	10/02/2007	10/02/2007	0		PVT	UNK	LISINOPRIL 2.5 MG;SINGULAIR 10 MG; ASPIRIN 81 G					1						1	Erythema; Injection site swelling; Myalgia; Pain in extremity; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~3~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0292356	10/06/2007	GA	52.0	52		F	10/06/2007	left upper posterior arm swelling, cool, no erythema, no hives or blistering.  At the time patient reports the reaction (approximately 4 hrs post vaccination) the area of swelling was the size of my palm (4inches in diameter). Pt was advised to apply cold compress, elevate left arm above heart as often as possible, and take oral benadryl every 4 hrs for 24hrs, report reaction to PCP, notify clinic if condition worsens.  Pt arm evaluated at private doctor's office 10/5/07				Y					U	10/04/2007	10/04/2007	0		UNK	PVT	triamterene, PTU, astma meds,other htn meds	none reported	1.right breast mastectomy year 2000 2. hypertension 3.hyperthyroidism 4. asthma			1						1	Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78990~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0889f~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0292357	10/06/2007	FL	67.0	67		F	10/06/2007	Received Pneumovax and Influenza, one in each upper arm.  Left upper arm very swollen, red, warm, painful.  Patient summary does not identify which vaccination was given in which arm, unable to learn which vaccination I am reacting to. Called Clinic, nurse never responded.  Went back to location, they said there was a computer problem yesterday and all records are lost, unable to tell me which vaccine was given in my left arm, which vaccine I am reacing to.									Y	10/05/2007				UNK	UNK		none	none			1						1	Erythema; Oedema peripheral; Pain; Skin warm	FLUX~UNKNOWN MANUFACTURER~unknown~7+~SC~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~unknown~2~SC~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0292358	10/06/2007	GA	49.0	49		M	10/06/2007	Patient fainted. Kept talking to patient and he eventually woke up after about 1 minute. Patient never stopped breathing.Patient stated that he was going to faint as soon as vaccine was given.									Y	10/06/2007	10/06/2007	0	n/a	UNK	UNK		n/a	Diabetes, seizures, hypertension			1						1	Immediate post-injection reaction; Syncope	FLU3~SANOFI PASTEUR~u2506aa~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0292359	10/06/2007	AZ	4.0	4		M	10/06/2007	Patient had been diagnosed with mild autism prior to receiving a flu vaccine in November 2005. His autism was mild and he was functioning well. Approximately two weeks following the flu shot he began regressing in skills on a global scale. From November up until February 2006 he gradually lost his ability to speak, eat with utensils, use the toilet, and socialize and interact with others and he also develped severe snesory processing issues. He frequently looked to be in pain but was unable to verbalize if he felt bad. On February 5, 2005 patient began a three month period of no speech or verbal sounds whatsoever. He made no noise at all, not even when he cried. We consulted his neurologist who was at a loss, but ordered an EEG and an MRI, both of which revealed nothing wrong with patient. We then consulted a Developmental Pediatric Specialist who advised us to put patient on a detoxifying gluten free/ casein free diet immediately. We attempted to add in supplements and fish oil to his diet but due to his sensory defensiveness he would not consume this items. One month after starting patient on the detox GF/CF diet he resumed speaking again, almost over night. Patient has made good progress regaining skills, but he still suffers from severe sensory processing disorder and his level of autism is not at a moderate level, whereas before it was extremely mild. For reference, I was not aware that VAERS existed and was never informed by a Dr that I should report this as an adverse reaction, which is why this has not been reported for the past two years. I was only recently made aware of VAERS and encouraged to report what happened.									Y	11/11/2005	11/25/2005	14	EEG-negative, MRI-negative	UNK	UNK	none	none	autism, allergy to DPT vaccine			1						1	Childhood disintegrative disorder; Condition aggravated; Electroencephalogram normal; Gluten free diet; Nuclear magnetic resonance imaging normal; Pain; Regressive behaviour; Sensory integrative dysfunction; Social problem; Speech disorder	FLUX~UNKNOWN MANUFACTURER~?~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0292360	10/07/2007	NC	60.0	60		F	10/07/2007	Patient returned to clinic 4 minutes after recieving flu vaccine reporting dizziness.  She started to collapse and was assisted to the floor.  She did not lose consciousness.  Denies shortness of breath, tachycardia.  911 called.  EpiPen Adult administered to right anterolateral thigh.  Patient reported extreme stress and emotional distress.  Patient transferred by ambulance to hospital for further evaluation.				Y					Y	10/07/2007	10/07/2007	0	BP 136/88 Pulse 88.  Random glucose-88	UNK	PVT						1						1	Blood glucose normal; Blood pressure; Dizziness; Emotional disorder; Stress; Syncope	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA298BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0292363	10/07/2007	AZ	63.0	63		F	10/07/2007	Three hours after shot, I developed tightening in throat and chest, difficult to swallow, some mild restriction of breathing - alleviated after taking  benadryl. (If the breathing and throat constriction had not improved, I would have called 911). Continued headiness somewhat like a head cold but without sinus drainage. Headache, joint pain and chills overnight. Low grade fever of 99.6 Symptons somewhat alleviated by taking aspirin. Next morning still some headiness with very little sinus drainage. Continued low grade fever, headache and joint pain. The area of the shot shows NO redness, tenderness or swelling and never has exhibited the expected reactions. I've not experienced a sore throat or coughing. Am continuing bed rest, fluids and aspirin.									U	10/06/2007	10/06/2007	0	N/A have not seen a doctor.	PUB	PVT	none	none	none			1						1	Arthralgia; Chest discomfort; Chills; Dysphagia; Dyspnoea; Headache; Pyrexia; Throat tightness	FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0292401	10/08/2007	CA	5.0	5		M	10/01/2007	14x10 cm redness and induration (L) deltoid area.									U	09/24/2007	09/25/2007	1	N/A	PVT	PVT	Singulair 4 mg QD	Serous otitis allergic rhinitis	Asthma, Allergies			1						1	Erythema; Induration	DTAP~SANOFI PASTEUR~C2552AA~5~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2487AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~1563F~2~SC~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0292407	10/08/2007	MN	15.0	15		F	10/03/2007	Pt noted redness to (L) arm just before came for appointment. Noted both at influenza and Varicella site with varicella cite also a little firmer and itchy. No hives, no difficulty breathing.									U	10/02/2007	10/03/2007	1		PVT	PVT		None	None - overweight			1						1	Erythema; Injection site induration; Injection site pruritus	FLU3~SANOFI PASTEUR~U2442AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB2073A~1~IM~RA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~11734~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0292417	10/08/2007	TX	12.0	12		F	10/08/2007	Rash on face - red and itching - started in AM on 10/8/07 behind (R) ear - pt took Claritin OTC.									Y	10/07/2007	10/08/2007	1		OTH	PVT		None	NKA			1						1	Erythema; Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA298AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0292419	10/08/2007	TN	29.0			F	10/03/2007	Left arm (elbow) swelling after injection of MMR (24) hrs after injection redness and swelling. Benadryl given today 10-3-07.									Y					PVT	UNK						1						1	Erythema; Oedema peripheral; Swelling	FLU3~SANOFI PASTEUR~80684~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0282U~UNK~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1023U~UNK~~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0292420	10/08/2007	OH	65.0	65		F	10/06/2007	Patient experienced extreme muscle soreness/weakness and went to ER the evening of vaccination. She was told by physician to take Ibuprofen and rest. Patient also had redness and swelling at site of injection. She received 2 injections in right arm because surgery on left side.				Y					Y	10/04/2007	10/04/2007	0	She was told at ER to take Ibuprofen for soreness.	OTH	PUB		None				1						1	Injection site erythema; Injection site swelling; Muscular weakness; Myalgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA794CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0061U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0292424	10/08/2007	NM	62.0	62		F	10/08/2007	Pt developed severe swelling of right arm and chest about 24 hours post vaccine. Erythema worsened over 48-72 hrs. Pt seen today with resolution of erythema and swelling.				Y					Y	10/02/2007	10/03/2007	1	CBC/CK/CMP - NL; Consult w/ orthopedic MD given the severity of rxn. Not a septic joint.	PVT	PVT			Hypothyroidism, Herniated lumbar disc			1						1	Blood creatine phosphokinase normal; Erythema; Full blood count normal; Laboratory test normal; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80684~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1035F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0292425	10/08/2007	KY	54.0	54		F	10/05/2007	Swollen, red, hot area of arm - size of silver dollar. Soreness, some low grade fever, flushed feeling.									Y	10/03/2007	10/04/2007	1	N/A	PVT	PVT						1						1	Erythema; Flushing; Oedema peripheral; Pyrexia; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80682~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0292426	10/08/2007	CA	85.0	85		F	10/08/2007	Redness and swelling in arm to wrist - pt went to clinic - seen by triage nurse - told to see MD tomorrow. No tx given as of 10/5/07.				Y					U	10/02/2007	10/04/2007	2	None	OTH	PUB		None	Heart cond - (not specified per pt)			1						1	Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~J2U988A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0961U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0292429	10/08/2007	NY	65.0	65		M	10/08/2007	severe fatigue, fevers to 102.5 F by patient history.  treated by private physician and instructed to take adult benadryl and advil. he stated he was advised via telephone.									Y	10/04/2007	10/05/2007	1	none	PVT	PVT	advair prn, zetia, lipitor, benacar, flomax, ambien prn.	none.	hyperlipidemia, hypertension, asthma?, occasional insomnia, BPH.			1						1	Fatigue; Pyrexia	FLU3~SANOFI PASTEUR~U2467AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0038U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0292431	10/08/2007	WI	66.0	66		F	10/08/2007	Patient experienced redness, swelling, and itching at site of injection.  Symptoms started on 10-6-07 and began improving thereafter.  Patient visited physician assistant on 10-8-07 and was given Zyrtec 10mg and Cephalexin 500mg tid for 10 days.  The PA diagnosed the patient with cellulitis, however, after examination, it appears to be an injection site reaction because the symptoms had improved from the first day.				Y					Y	10/05/2007	10/06/2007	1	normal	UNK	UNK		Normal	none			1						1	Cellulitis; Injection site erythema; Injection site pruritus; Injection site reaction; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78479~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0964u~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0292432	10/08/2007	MI	55.0	55		F	10/08/2007	Swelling under left eye and rash									N	10/05/2007	10/05/2007	0	NONE	UNK	PVT	MAXIDE	NONE	ALLERGIES	SELF~Influenza (Seasonal) (Fluvirin)~1~55.80~In Patient		1						1	Eye swelling; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0292433	10/08/2007	AR	74.0	74		F	10/08/2007	This patient received a Flu shot on 10/2/07 and started running fever on 10/5/07 of 104.  She stayed home Friday and Saturday and had 104 fever on Saturday evening.  On Sunday at 1620 with c/o fever and chills with generlized weakness and falls. WBC 7.0 At the time of this report the patient is an Inpatient at Piggott Community Hospital.  10/10/2007 MR received for hospital DOS10/07-09/2007 for the Assessment/DX of Fever, Weakness, Chronic A-fib.  Pt presented to ER with c/o chills, generalized weakness, and 2 recent falls at home.  Admitted for IVF and abx.  PE significant for T'=102.7.  Heart sounds irregularly irregular with 3/6 systolic murmur.  2+ edema in legs. Per 60 day follow up: Pt's husband stated the doctor's did not think the illness was related to the Flu vaccine-she is doing well.				Y	Y	3			Y	10/02/2007	10/05/2007	3	Labs and Diagnostics:  EKG shows a-fib with rate in 90's.  CXR (-).  Sed rate 28.  Influenza AG A/B (-). UA 10-15 RBCs Trace ketones, small bilirubin, protein 100. Serum Na 131-134.  Glucose 112. PT 14.2-16.1.	UNK	UNK		None	Heparin. PMH:  Chronic A-fib, asthma, migraines, OA.			1						1	Asthenia; Chills; Fall; Pyrexia; White blood cell count normal	FLU3~SANOFI PASTEUR~U2493AAorU2442A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0292438	10/08/2007	FL	41.0	41		F	10/08/2007	SWELLING BELOW SITE OF INJECTION, WITH ITCHING, TIGHTNESS AND REDNESS.									N	10/06/2007	10/07/2007	1		PUB	UNK	NONE	NONE	NONE			1						1	Erythema; Pruritus; Skin tightness; Swelling	FLUX~UNKNOWN MANUFACTURER~UNKNOWN~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0292440	10/08/2007	NC	61.0	61		F	10/08/2007	Became very sleepy 8 hours post, slept 12 hurs straigt, awoke with cough, wheezing, tightness of chest, red painful eyes with blurry vision, copious discharge from nose similar to severe respiratory allergic reaction									Y	10/05/2007	10/06/2007	1		UNK	PVT	diovan HCT, tiazec , fluticasone inhaler	none	penicillin, keflex allergies, number of respiratory allergies, rheumatoid arthritis (currently unmedicated), hypertension			1						1	Chest discomfort; Cough; Eye pain; Hypersensitivity; Ocular hyperaemia; Rhinorrhoea; Somnolence; Vision blurred; Wheezing	FLU3~SANOFI PASTEUR~U2467AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0292443	10/08/2007	NC				U	10/08/2007	Patient lost consciousness immediately after receiving Fluarix lot # AfluA298BA for approx 30 seconds and had a brief tonic-clonic seizure affecting her neck, arms, and hands.				Y					Y	10/08/2007	10/08/2007	0		UNK	UNK						1						1	Grand mal convulsion; Loss of consciousness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA298BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0292445	10/08/2007	CA	84.0	84		F	10/08/2007	Patient devloped a fever the day following administration of a influenza vaccine. Yesterday she had severe body aches and was confused.  She was seen at the emergency room.  She had a full workup for an infectious illness none was found.  He fever resolved and she felt much better after started takeing tylenol.				Y					Y	10/03/2007	10/04/2007	1		PVT	PVT	multiple	no	hypertension osteoarthritis peptic ulcer disease lumhar spinal stenosis valvular heart disease polymyalgia rheumatica			1						1	Confusional state; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflla039aa~UNK~IM~LL~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0292446	10/08/2007	CA	87.0	87		M	10/08/2007	12 hours after the Flu Shot, pt complained that he could not move the arm of injection site, felt extreme discomfort (stiffness and pain)around the shoulder, neck and chest.He also had violent headache and nausea. He went to ER after four days of continuous discomfort and malaise, he was given a Vicodin rx for pain and sent home. His discomfort and malaise went away after one week.				Y					Y	09/25/2007	09/26/2007	1	Head MRI, EKG were done at ER and results were normal. He had slightly elevated white blood count	UNK	PVT	Lisinopril, Phenobarbital,	Astelin Nasaly Spray, Vicodin	n/a			1						1	Discomfort; Electrocardiogram normal; Headache; Injected limb mobility decreased; Malaise; Musculoskeletal stiffness; Nausea; Nuclear magnetic resonance imaging normal; Pain; White blood cell count increased	FLU3~SANOFI PASTEUR~U2504AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0292434	10/09/2007	CA	5.0	5		M	10/09/2007	5 yo boy presented with left arm edema/erthema 10 hours after influenza vaccine; admitted to hospital for vaccine reaction vs cellulitis and discharged on 10/8 with imporved sympotms and no evidence of cellulitis10/22/07-records received for DOS 10/6-10/8/07-DC DX: Vaccine Reaction with Possible Asthma Exacerbation. developed left arm pain, edema, erythema 10 hours after receiving influenza vaccine. crackles and wheezes heard on pulmonary exam. Treated for vaccine allergy reaction vs cellulitis. Pruritis.				Y	Y	2			Y	10/06/2007	10/06/2007	0		UNK	UNK		no 10/22/07-Tactile fever, URI with symptoms of rhinorrhea, sore throat and cough 1 week prior,	eggs 10/22/07-records received-HX: asthma and egg allery,			1						1	Erythema; Hypersensitivity; Oedema; Vaccination complication	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0292469	10/09/2007	MS	54.0	54		F	10/09/2007	This case was reported by a healthcare professional and described the occurrence of a local reaction at injection site in a 54-year-old female subject who was vaccinated with Flulaval, GlaxoSmithKline. On 2 October 2007 the subject received 1st dose of Flulaval at 0.5 ml in the left arm. On 2 October 2007, at an unspecified time after vaccination with Flulaval, the subject experienced a local reaction at injection site and her arm became sore. On 3 October 2007, the subject's arm became red, swollen and tender. On 5 October 2007, the subject was examined by the reporter who stated that the subject's symptoms had gotten progressively worse. The redness moved down her arm. The healthcare professional considered the events were disabling. The nurse prescribed Benadryl, Tylenol and Motrin for the subject. The healthcare professional considered the events were probably related to vaccination with Flulaval.								Y	U	10/02/2007	10/02/2007	0	UNK	PVT	OTH		Unknown			A0686762A	1						1	Erythema; Local reaction; Oedema peripheral; Pain in extremity; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA042AA~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Disabling	Influenza
0292479	10/09/2007	MA	73.0	73		M	10/05/2007	One day after immunizations patient presented with redness, pain, swelling left deltoid area. Treated with oral Clindamycin 300mg 4 times a day plus IV Clindamycin 600mg on 10/3/07, 10/4/07; seen again 10/5/07 - sent to for admission due to lack of resolution. 10/30/07-records received for DOS 10/5-10/06/07-DC DX: Cellulitis. C/O worsening cellulitis left arm after receiving flu shot 3 days ago. Swelling, warmness and tenderness at injection site of posterior left deltoid, spread to posterior arm and tracked down to anterior cubital fossa.					Y	1				10/02/2007	10/03/2007	1	WBC 12.4, ANC 10.8 (1.5-7.8) 10/3/07 WBC 11.7, ANC 9.4 10/5/07	PUB	PUB	ASPIRIN EC 325mg 1 tablet daily, LIPITOR 80mg 1 tablet daily, ZYRTEC 10mg 1 tablet daily, CLINDAMYCIN HCL 300mg 1 tablet every 6 hours, ZESTRIL 10mg 1 tablet every day for blood pressure, METOPROLOL SUCCINATE 25mg 1 tablet every day (Long A	No acute illnesses	Routine medical exam. hyperplas pros unspec W/O obst, visual disturbances NEC, Calculus of kidney, acute URI NOS, Benign hypertension, ASCVD 2003 ischemic heart disease with stent placement, Ca in situ skin NOS Basal cell ca L forearm, 3/15/07 High, Actinic keratosis  record received 10/30/07-PMH:HTN, hyperlipidemia, CAD with 3 vessel stent. BCC			1						1	Erythema; Neutrophil count increased; Oedema peripheral; Pain in extremity; White blood cell count increased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLL036AA~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PNC~PFIZER\WYETH~1229F~1~SC~LA~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0292486	10/09/2007	NY	2.0	2	.1	F	10/02/2007	Urticarial rash began 3 days after DTaP and Fluzone vaccine given.									Y	09/28/2007	09/30/2007	2	None	PVT	PVT		None	None			1						1	Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B049~4~IM~UN~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2460AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0292490	10/09/2007	VA	72.0	72		M	10/09/2007	Fever, redness, pain in the area right arm.									N	10/05/2007	10/06/2007	1	None	PUB	UNK		No	Lotrel, Lipitor, Astelin, Taclofenac			1						1	Erythema; Pain in extremity; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0292507	10/09/2007	AK	59.0	59		F	10/02/2007	Pt complains of pain after one week following flu shot, can not raise arm.									N	10/02/2007	10/02/2007	0		UNK	PVT		Unknown	Unknown; MS ?			1						1	Injected limb mobility decreased; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA305AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0292508	10/09/2007	CO	75.0	75		M	10/03/2007	Moderate swelling on the day when administered. Redness the following day with fever of 102.6. The 3rd day started feeling better, redness remains and less painful. Pt took Benadryl 50mg and aspirin 325mg twice the day after vaccines administered.									Y	10/03/2007	10/04/2007	1	Fever measured at 102.6	OTH	OTH	None	None	None			1						1	Erythema; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U2453AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0038U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0292515	10/09/2007	FL	59.0	59		M	10/09/2007	Weakness,Paleness,Dizziness									Y	10/05/2007	10/06/2007	1		MIL	PUB	Zanex,lisinopril.Folic acid,Crestor,Opramozol,Vit.D.VitB,Colestipol,Restasis,Indomethacin,Terasosin,Gabapentin		Tetanus (Horse Serum)			1						1	Asthenia; Dizziness; Pallor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0292518	10/09/2007	NE	45.0	45		F	10/09/2007	Received PPD L FA on 10-2-07 for yearly check. On 10-04, pt. came to me and showed me the PPD site. Induration was measured at 40mm and redness was also present. Pt. states that she noticed yesterday evening that it was red and swollen. No itching. Pt. was refered to occupational health on this same day. Chest X-ray was done and results were negative. Pt. states that it remained red and indurated until evening of 10-7-07.				Y					Y	10/02/2007	10/03/2007	1	Chest X-ray done at Concentra occupational health results were: No acute cardiopulmonary process.	UNK	PVT	None	None	None			1						1	Chest X-ray normal; Tuberculosis skin test positive	FLU3~SANOFI PASTEUR~U2466AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0292523	10/09/2007	MN	16.0	16		M	10/09/2007	SEVERE SHORTNESS OF BREATH, GRAY COLOR, ITCHINESS OF FACE AND HEAD; NO HIVES				Y					Y	10/02/2007	10/02/2007	0	ANAPHLACTIC REACTION TO INFLUENZA VACCINE	UNK	UNK	PRILOSEC; ZYRTEC D	NONE	ASTHMA			1						1	Anaphylactic reaction; Dyspnoea; Pallor; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA302AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0292529	10/09/2007	FL	39.0	39		F	10/09/2007	Got flu vaccine and PPD on 10/8/07 about 11am,  Around 1pm noticed red spots around abdomen area, spreading to back, no itching, no swelling, no difficulty breathing.  Rash gone by morning of 10/9/07									Y	10/08/2007	10/08/2007	0	none	PUB	PUB	TB skin test given on 10/8/07.	none	none			1						1	Rash	FLU3~SANOFI PASTEUR~u2488aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0292531	10/09/2007	SC	54.0	54		M	10/09/2007	0.5 ml fluvirin shot was given approximately at 9:30am.  Pt returned to clinic at 11:40am with complaints left side of jaw and face swollen.  Denied ss of SOB, itching or rash.  He stated at this time a few weeks ago he had bells palsy.  He refused benadryl and siad that he was headed to the walkin clinic at Hospital.				Y					U	10/09/2007	10/09/2007	0		UNK	UNK	none	states he had recent history of Bell's Palsy but only after he reported face swelling	hx of gout			1						1	Jaw disorder; Swelling face	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78994~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0292532	10/09/2007	FL	49.0	49		M	10/09/2007	Difficulty breathing, began about 2.5 hours after FLU vaccination, unable to come back to normal as of 5:45 pm, time of completing this form									N	10/09/2007	10/09/2007	0		UNK	PVT	None	None	None			1						1	Dyspnoea	FLUX~UNKNOWN MANUFACTURER~~2~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0292534	10/09/2007	WI	74.0	74		F	10/09/2007	Pt received vaccination and stated felt dizzy, wanted to lay down; reclined on exam table and became diaphoretic, eyes rolled back, gray/ ashen color, did not respond to name or brisk shaking for approx 15-20 secs; weak/ th ready pulse 70s, BP 84/40s, RR=12, Pulse ox= 99%; 911 called immediately; 0.3 mg SQ epi administered while awaiting ambulance; Pt responding by time ambulance arrived in approximately 5 minutes; BP 100s/70s, then 140s/70s, responsive, A&OX3; taken to ER via ambulance by Fire Dept.				Y					Y	10/09/2007	10/09/2007	0	Pt sent to ER via parametics	UNK	UNK		None	Stated sulfa as a teenager			1						1	Dizziness; Gaze palsy; Hyperhidrosis; Hypotension; Pallor; Pulse abnormal; Pulse pressure decreased; Unresponsive to stimuli	FLU3~SANOFI PASTEUR~U2450AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0292537	10/09/2007	TX	52.0	62		F	10/09/2007	Immunized flu and pneumonia same arm 10-01-07. On 10-02-07 patient's arm was imflamed at injection site.  shortness of breath. called ambulance to ER.				Y					Y	10/01/2007	10/02/2007	1	N/A	UNK	UNK	unknown	none	N/A	N/A~ ()~NULL~~In Patient		1						1	Dyspnoea; Injection site inflammation	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua305aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0989u~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0292561	10/10/2007	SC	0.5	0	.5	M		intussusception confirmed by abdominal x ray, abdominal ultrasound at 10-5-07 10/22/07-records received for DOS 10/5-10/7/07-DC DX: Intussusception. Laparotomy, appendectomy. Operative reduction of intussusception. Hydrostatically irreducible. Three days prior to admission C/O abdominal pain and emesis, HX of episodic pain, no bloody bowel movements.				Y	Y	2			Y	10/02/2007	10/05/2007	3	Abdominal Xray, Abdominal KUB 10/22/07-records received-KUB showed dilated loops of bowel with air fluid levels. Ultrasound diagnostic for intussusception. 11/15/07-records received-11/15/07-tissue slide report received: specimen appendix.IHC for adenovirus positive. IHC for Rotavirus A negative.	PVT	PUB		None	None			1						1	Abdominal X-ray; Intussusception; Urinary system X-ray; Intussusception; Ultrasound scan abnormal; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B115CB~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2435AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF119AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B47300F~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0410U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1|RV5~MERCK & CO. INC.~~UNK~PO~MO~ROTAVIRUS (ROTATEQ)~2|UNK~UNKNOWN MANUFACTURER~~UNK~UN~UN~VACCINE NOT SPECIFIED (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0292565	10/10/2007	MN	49.0	49		F	10/04/2007	Routine annual employee flu vaccination (R) 1510 deltoid 0.5 ml IM with rapid response - no anxiety, pallor, tachycardia, restlessness - refusal at 1st by staff member/client of emergency SRI with return of color, decreased pulse, decreased anxiety followed by another rapid episode of pallor, anxiety, tachycardia. ).5 ml Epinephrine SQ given 15:25 hrs just prior to ambulance arrival - transport to ER for further Rx - O2, Benadryl, fluids.  10/15/2007 MR received for ER visit 10/03/2007 with DX of Reaction.  Pt presented to ER with onset of light-headedness, tunnel vision, palpitations and feelings that her heart was racing and just not feeling right within a few minutes of receiving flu shot. Similar reaction to bee stings and shrimp in past. Epi and Benadryl given at the scene.  PE WNL. No true signs of anaphylaxis, cardiac ischemia, or hypoglycemia.  D/ C home.			Y	Y					Y	10/03/2007	10/03/2007	0	Labs, EKG done in ER 10/3/07. Staff member/patient reports WNL.  Labs and Diagnostics:  EKG WNL. Chemistry with Glucose 136 and K+ of 3.0.	OTH	PVT	None	None	History Reaction to Bees, shrimp, Latex. Similar reaction to bee stings and shrimp in past.			1						1	Anxiety; Electrocardiogram normal; Pallor; Restlessness; Tachycardia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening	Influenza
0292567	10/10/2007	FL	19.0	19		F	10/02/2007	Rash, vomiting, dizzy, headache, nausea, light-headed.				Y					N	09/27/2007	09/27/2007	0	CBC, CMP - normal	PVT	PVT	Lexapro x 1 dose	None	Allergic rhinitis, anxiety, low back pain			1						1	Dizziness; Full blood count; Headache; Laboratory test normal; Nausea; Rash; Vomiting	FLU3~SANOFI PASTEUR~U2439AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0292582	10/10/2007	AZ		0	.0	M	10/03/2007	Had shot on 10/1/07 (L) arm, became very swollen, red, site warm, had fever. Size per Dr (L) arm 4.7, (R) 6x8.										10/01/2003				PVT	PVT	None	None	None			1						1	Erythema; Injection site warmth; Oedema peripheral; Pyrexia	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B056BA~UNK~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2443AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0292589	10/10/2007	MA	5.0	5		M	10/10/2007	Nothing has happened at this time. Parent notified to give pain meds as needed per nurse.										10/10/2007				PVT	PVT	Singulair 4mg qd	No	Asthma, Allergic rhinitis			1						1	Wrong drug administered	FLU3~SANOFI PASTEUR~U2469AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~0620U~UNK~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0292590	10/10/2007	NJ	48.0	48		F	10/10/2007	Severe hives, cortisone injection, Zyrtec at bedtime, Allegra 180 during day, 8 dys Prednisone.				Y					N	09/25/2007	09/30/2007	5		PVT	UNK	None	None	Food Allergies - but not to eggs			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2462AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0292592	10/10/2007	TX	76.0	76		F	10/08/2007	Pain on shoulder. Redness on shoulder and swelling moving to above elbow.				Y						10/03/2007	10/05/2007	2		OTH	PVT		N/A	None reported			1						1	Erythema; Musculoskeletal pain; Oedema peripheral	FLU3~SANOFI PASTEUR~U2493AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0200U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0292594	10/10/2007	TN	0.8	0	.8	M	10/08/2007	Seizure <1 hr after receiving HBV #3 and 1st flu vaccine.				Y					Y	10/04/2007	10/04/2007	0	Evaluated at ER and released to parent.	PVT	PVT	Amoxicillin	6th day of ABX for (B) OM	Down's Syndrome			1						1	Convulsion	FLU3~SANOFI PASTEUR~U2449AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0570U~3~IM~RL~HEP B (RECOMBIVAX HB)~1	USA	Emergency room visit	Influenza
0292602	10/10/2007	WY	48.0	48		F	10/05/2007	Client received flu vaccine during drive thru exercise on 10-3-07 at park. She called today 10-4-07 at 11:25 and stated she was having tightness in her chest. She was referred to her Dr. to seek medical advice. 10-8-07 Follow up TC to pt. Pt. states that she felt better on 10-4-07 and no complaints since.									Y	10/03/2007	10/04/2007	1	None	PUB	PUB	Baby aspirin	None	None			1						1	Chest discomfort	FLU3~SANOFI PASTEUR~2441AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0292617	10/10/2007	MN	24.0	24		F	10/10/2007	With no allergies to eggs, I developed hives that benedryl could not take care of.  I work at the clinic it was given at and had gotten my shot at the start of my shift which was about 3:30 p.m.  I started feeling itchy on the upper part of my body within a couple of hours.  I did not realize what was actually going on until I had gotten home and getting ready for bed and saw that I had broke out in hives all over which were becoming more and more prevalent and noticeable.  I then took benedryl before I went to sleep; however, when I awoke I had found that i had gotten worse even with using the benedryl.  I then had gone back to the clinic in Urgent care in order to get some sort of treatment.  I was then treated with a shot of Prednisone and was given zyrtec to take for the week.				Y					Y	10/09/2007	10/09/2007	0		PVT	UNK	Tri Sprintec	None.	I had been allergic to food dyes yellow number 5 and 6; however these have not affected me in over 15 years.  I do, however, may have an allergy to preservatives; however, that has not been diagnosed by a doctor.	Allergic reaction (Hives)~Influenza (Seasonal) (no brand name)~1~24.80~In Patient		1						1	Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0292624	10/10/2007	MH	11.0			M	10/10/2007	Child was give 2 flu Vaccines and a 3rd Hep A.No reaction at the site,No adverse reactions noted.														PVT	PVT	none	none	none			1						1	No adverse reaction; Overdose	FLU3~SANOFI PASTEUR~U2439AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB206CA~3~IM~LA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U240AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~1008U~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0292629	10/10/2007	NC	30.0	30		F	10/10/2007	Difficulty breathing, paleness, weakness, fast heart beat, dizziness, low blood sugar, vomiting, nausea.  Had to be treated at hospital.				Y					Y	10/09/2007	10/09/2007	0		UNK	UNK	none	none	none			1						1	Asthenia; Blood glucose decreased; Dizziness; Dyspnoea; Heart rate increased; Nausea; Pallor; Vomiting	FLUX~UNKNOWN MANUFACTURER~unknown~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0292631	10/10/2007	NV	73.0	73		M	10/10/2007	PT began having T101, chills and difficulty sleeping, called PMD 10/04/07 at 3pm and inst to take Motrin, fever broke at 430p. By 1130p T103.7, went to ER given fluids and Levoquin, blood work. 10/06/07 at 1200n, T98.8, R arm remains red, painful to touch to elbow				Y					Y	10/03/2007	10/04/2007	1		PUB	PVT	pt received Gammaglobulin injection 10/02/07	states in remission from Lymphoma	Pt diagnosed with Lymphoma CA. 2units Radiated blood transfusion 2002.			1						1	Blood test; Body temperature increased; Chills; Injection site erythema; Injection site pain; Insomnia; Pyrexia; Rash; Rhinorrhoea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~afua294fa~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0962U~1~IM~RA~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~0618U~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~~UNK~IM~~PNEUMO (NO BRAND NAME)~2|VARZOS~MERCK & CO. INC.~~UNK~IM~~ZOSTER LIVE (ZOSTAVAX)~2	USA	Emergency room visit	Influenza
0292634	10/10/2007	MI	62.0	62		M	10/10/2007	On 10/9/07 at about 8:00PM: Headache, Fatigue, Swollen and sore lymph nodes under right arm and right elbow sore, Soreness in right deltoid site of injection.  At about 9:30 Fever started.  At about 10:00PM began Wheezing and coughing.  On 10/10/07 Awoke with Headache and Fatigue. Headache subsided midafternoon.  Fatigue lasted all day. Lymph nodes were still sore but less than previous night soreness lasted all day. It is now 8:30Pm on 10/10/07.									U	10/09/2007	10/09/2007	0		UNK	PVT	None	None				1						1	Cough; Fatigue; Headache; Injection site pain; Lymph node pain; Lymphadenopathy; Pyrexia; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua294ea~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0885f~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0292705	10/11/2007	NH	72.0	72		F	10/08/2007	Within a few hours, swelling and redness on right deltoid. No systemic symptoms, no throat or respiratory symptoms SC edema noted with tenderness on exam. Treated with Medrol dose pack and ice.				Y					Y	10/05/2007	10/06/2007	1		PVT	OTH	SEE ATTACHED	HYPERLIPIDEMIA, HYPERTENSION, DIABETES TYPE 2	ALLERGIES: IODINE			1						1	Erythema; Oedema peripheral; Tenderness	FLU3~SANOFI PASTEUR~U2498AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0554U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0292706	10/11/2007	WI	4.0	4		M	10/08/2007	Received vaccine 10/4/07. Mother reported to father that child had temp of 102.5 and was almost seizing. Followed up 10/8/07. No further fever, s/sx detected.									Y	10/04/2007	10/04/2007	0	None	PUB	PUB	None	None	None			1						1	Body temperature increased; Convulsion	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B046AA~5~IM~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2438AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0326~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0254F~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1178U~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0292720	10/11/2007	OR	62.0	62		F	10/11/2007	Administered 10/8/07 at 10:42. Fever 102.9, weakness, to ER about 12 hrs after injection. Blood culture negative.				Y	Y	1			Y	10/08/2007	10/08/2007	0	Blood cultures neg	PVT	PVT			Penicillin and Sulfa allergies			1						1	Asthenia; Blood culture negative; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLL040AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation	Influenza
0292723	10/11/2007	CA	32.0	32		F	10/10/2007	10-10-07 0030 received Influenza vaccine IM. 0100 - developed hives on arm and shortness of breath. Throat started to close. 0105 - seen in emergency room - 0.3cc (1:1000) Epinephrine SQ given at 0115.				Y					Y	10/10/2007	10/10/2007	0		PUB	PVT		None	Recent allergic reaction to Calamari	felt hot and flushed~Td Adsorbed (no brand name)~~32.00~In Patient		1						1	Dyspnoea; Throat tightness; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA311AA~1~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0292724	10/11/2007	TX	49.0	49		M		1) Swelling at injection site									U	10/10/2007	10/10/2007	0		OTH	PVT	Patient currently taking Niacin and Tricor					1						1	Injection site swelling	FLU3~SANOFI PASTEUR~U2445AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0292725	10/11/2007	VI	42.0	42		M	10/11/2007	Flu like symptoms, fever, diarrhea (4 times home, 2 times work)									U	10/10/2007	10/11/2007	1	None	MIL	MIL		None	Aspirin			1						1	Diarrhoea; Influenza like illness; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500485P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0292726	10/11/2007	PA	11.0	11		M	10/11/2007	Varicella vaccine administered 9/25/07. On 9/27/07 mother called to state that redness, swelling and small vesicles occurred around site of injection.									Y	09/25/2007	09/26/2007	1	None	PVT	PVT		None	None			1						1	Injection site erythema; Injection site swelling; Injection site vesicles	FLU3~SANOFI PASTEUR~U2465AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2402AA~1~~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B016BA~1~~LA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1116U~2~~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0292727	10/11/2007	MD	83.0	83		F	10/11/2007	Patient received Zostavax 10/3/07.  On 10/6/07 developed back pain by 10/9/07 rash upper left side along dermatones T6T4.  Seen in ER with f/u MD office visit.  Received Valtrex, Percocet.				Y					N	10/03/2007	10/06/2007	3	Herpes Zoster	PVT	PVT	TYLENOL #3, TYLENOL, LIPITOR, ASA	NONE	OSTEOARTHRITIS/ HYPERLIPIDEMIA			1						1	Back pain; Herpes zoster; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA055AA~1~SC~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|VARZOS~MERCK & CO. INC.~0884U~1~IM~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0292730	10/11/2007	IN	14.0	14		F	10/11/2007	Edema to lips									U	10/10/2007	10/11/2007	1		PVT	OTH		None				1						1	Lip oedema	FLUN3~MEDIMMUNE VACCINES, INC.~500487P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0292731	10/11/2007	CA	7.0	7		F	10/11/2007	Pain, fever to 103.7 tx - cool compress - PRN Tylenol with Codeine - PRN pain q 4-6 hrs.									U	10/09/2007	10/09/2007	0		PVT	UNK						1						1	Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2443AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0860U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0292734	10/11/2007	SC	0.5			M	10/11/2007	Patient had his 1s Flu and Pediarix #3 and Prevnar #3 and Hib #3 10-4-07 AM and around 6-7 PM grandmother found him warm and had 3-4 seconds of shaking his upper extremities and rolling up his eyes; possible febrile seizure seen in hospital ER sent home.									Y				None	PVT	UNK	ZANTAC	None	None			1						1	Gaze palsy; Skin warm; Tremor	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B115CB~UNK~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2445AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF163AA~UNK~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B47300F~UNK~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0292736	10/11/2007	CA	13.0	13		F	10/11/2007	C/O numbness left face ~ 3 hours after injection given, no numbness at time of exam, located ~ 12 hours.				Y					Y	10/10/2007	10/10/2007	0		PVT	UNK	None	None	None			1						1	Hypoaesthesia facial	FLU3~SANOFI PASTEUR~U24589C~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0292742	10/11/2007	TX	38.0	38		F	10/11/2007	Fever, chills, joint ache, sore throat, weakness, and dizziness.									N	10/09/2007	10/09/2007	0		UNK	UNK		None	None			1						1	Arthralgia; Asthenia; Chills; Dizziness; Pharyngolaryngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0292743	10/11/2007	VA	69.0	68		F	10/11/2007	Approx 7 pm 10/3/07, had fever (approx 103), chills, headache & body achiness over entire body fro approx 12 hrs.  Tylenol every 4 hrs - 7 pm until 7 am (extra-strength).  Bedrest & tired during am of 10/4/07; pm - weak.  Better 10/5/07.  Injection site slightly tender post injection- some itching, no swelling									Y	10/03/2007	10/03/2007	0	had flu shot yearly the past several years - exact number of doses unknown	PUB	PUB		none	no allergies		VA07:016	1						1	Asthenia; Chills; Fatigue; Headache; Injection site pain; Pain; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~U2439AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0292744	10/11/2007	MD	50.0	50		M	10/11/2007	Malaise beginning 18 hours after vaccine followed by Generalilzed Puritic skin rash 51 hours after vaccine.  Self treated with Tylenol, ibuprofen,  and Benadryl.									N	10/03/2007	10/05/2007	2		UNK	UNK	none	none	none			1						1	Malaise; Pruritus generalised; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA041AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0292745	10/11/2007	IN	22.0	22		M	10/11/2007	Developed Bells Palsy 3 days after administration of flu vaccine. R side of face affected. Treated with medrol dose pack and acyclovir. 10/15/07-received vac record and statement from reporter-patient developed Bell's Palsy 3 days after flu shot, treated with acyclovir and medrol dose pack per her father a physician.				Y					N	10/03/2007	10/06/2007	3		UNK	UNK						1						1	Facial palsy	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80063~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0292746	10/11/2007	VA	4.0	4		M	10/11/2007	arm redness and swelling, hot to touch, painful										10/09/2007	10/10/2007	1		PVT	PVT		none				1						1	Erythema; Pain in extremity; Skin warm; Swelling	FLU3~SANOFI PASTEUR~U2506AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB182AA~2~IM~LA~HEP A (HAVRIX)~1	USA		Influenza
0292750	10/11/2007	NC	65.0	65		F	10/11/2007	Patient reported that approx 30 min after recieving the Fluvirin that she experienced excutiating pain in her right arm and shoulder. She went to her Physician's office and there she began having breathing difficulties and was given a Benadryl injection. An EKG was performed and she reported that there were no abnormalities.				Y					Y	10/10/2007	10/10/2007	0	EKG	UNK	UNK	Prednisone, Fluconazole, Avapro, Synthroid, Dratrana, Zantac, Klonopin and Cymbalta	Thrush	Beta and Calcium Channel Blockers, ACE Inhibitors, Some Anti-Depressants,Anti-Hypertensives and some Anti-biotics (Client unable to provide any specific drug names)			1						1	Dyspnoea; Electrocardiogram normal; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80432~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0292751	10/11/2007	MO	26.0	26		F	10/11/2007	Dizziness, weakness, headache which lasted 5 hours.									Y	10/10/2007	10/10/2007	0	None	PUB	PVT	Celexa and Lo-Estrin birth control	None	None	None~ ()~NULL~~In Patient		1						1	Asthenia; Dizziness; Headache	FLU3~SANOFI PASTEUR~U2466AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0292752	10/11/2007	MI	13.0	13		F	10/11/2007	Approximately 5 minutes after administration, patient became very flush, dizzy and lightheaded. Also somewhat weepy. Pulse okay. Incident lasted 5 minutes. Patient stayed for observation for 20 minutes and felt fine at release. --Mother did disclose after reaction that child had egg allergy as infant but resolved at 3 years of age and has been eating eggs since.									Y	10/11/2007	10/11/2007	0		UNK	PVT		None	None			1						1	Crying; Dizziness; Flushing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80062~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0292753	10/11/2007	NC	70.0	70		M	10/11/2007	Tenderness, increased warmth, slightly edmatous. Area at site of injection began to sting almost immediately after injection per client									Y	10/10/2007	10/10/2007	0	None	PUB	PVT	None	None as reported by client	None as reported by client			1						1	Injection site pain; Oedema; Skin warm; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80432~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0292755	10/11/2007	CA	63.0	63		F	10/11/2007	Within 48 hrs of administration pt had redness and swelling and warmth of arm from shoulder to antecubital fossa				Y					U	10/09/2007	10/10/2007	1		PUB	PVT	no changes	None	None			1						1	Erythema; Oedema peripheral; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~738837~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~07330~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0292756	10/11/2007	IA	0.5	0	.5	U	10/11/2007	Patient received 0.5 ml dose of MMR. Dr notified immediately when realized MMR given in error. Dr. notified mother, and discussed incident with her, as well as answered questions for mother. Manufacturer (Merck) notified.									Y	10/11/2007	10/11/2007	0	NONE	UNK	UNK	NONE	NONE	NONE			1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U2450AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF119M~UNK~IM~~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0807U~UNK~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08700E~UNK~IM~~PNEUMO (PREVNAR)~1	USA		Influenza
0292759	10/11/2007	PA	1.92	1	1	F	10/11/2007	maculopapular rash and hives on trunk, face, and extremities approx. 16 hours after infuenza virus-pediatric dose was given     Patient was also receiving augmentin for and ear infection at the time of vaccination.  So not sure if drug reaction or vaccine reaction.				Y					N	10/10/2007	10/11/2007	1		PVT	PVT	augmentin	on day 8 of therapy with augmentin ES 600 for a right otitis media	non			1						1	Rash maculo-papular; Urticaria	FLU3~SANOFI PASTEUR~UT2456BA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0292762	10/11/2007	MA	54.0	54		F	10/11/2007	2.5 hours after vaccine administered: scratchy throat, swelling throat, itchy eyes, red sclera, wheezing, rash on chest (that went away). Pt initally took 25 mg of Benadryl followed up later with 50 mg Benadryl with some relief to symptoms. Came to the ER next day due to wheezing (as past hx of cold related asthma, but not recently).Was given a nebulizer in ER.				Y					Y	10/10/2007	10/10/2007	0		PVT	PVT	Unknown	None reported. Pt. denied being ill.		Unknown~ ()~NULL~~In Patient|Unknown~ ()~NULL~~In Sibling1|Unknown~ ()~NULL~~In Sibling2		1						1	Eye pruritus; Pharyngeal oedema; Rash; Scleritis; Throat irritation; Wheezing	FLU3~SANOFI PASTEUR~U2462AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0292763	10/11/2007	FL	39.0	39		F	10/11/2007	Patient was vaccinated on 10-01-2007 and began to feel ill on 10-06-07.Patient missed work on 10-10-2007 and as of today is running a 103 fever. As of 10-10-2007 patient is drinking advil liquid gel, if fever persist patient will be taken to hospital tonight.									U	10/01/2007	10/06/2007	5		UNK	UNK		None				1						1	Malaise; Pyrexia	FLU3~SANOFI PASTEUR~U2451AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0292766	10/11/2007	CA	67.0	67		F	10/11/2007	Itching burning hemmorhoids-6-12 hours after shot.bright pink skin tone all over after 3 days, with slight, all over itch which continues now on day 8.				Y					N	10/04/2007	10/04/2007	0		PUB	UNK		none				1						1	Burning sensation; Haemorrhoids; Pruritus; Skin discolouration	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0292768	10/11/2007	CA	42.0	42		F	10/11/2007	Pt developed 1 & 1/2 inch square red patch at the injection site 24 hours after Fluzone vaccine that was adminstered on 10/01/2007.  The patch was warm to the touch.  On 10/03/2007, pt. started applying Neosporin ointment and the patch resolved quickly.									Y	10/01/2007	10/02/2007	1	None	UNK	UNK	None	None	None	None~ ()~NULL~~In Patient|None~ ()~NULL~~In Sibling1|None~ ()~NULL~~In Sibling2		1						1	Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~u2454aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0292769	10/11/2007	GA	85.0	85		F	10/11/2007	Patient received fluzone on Tuesday, Oct 9. Called pharmacy on Wednesday complaining of swelling and pain at injection site. Advised to take tylenol and possibly use some ice for swellling. Phoned again Thursday and complained swelling and pain had become worse. Asked patient to come down for an assessment. Swelling present on shoulder. Also had pain on top of arm and under arm. Skin appeared spotty with red patches. No other areas of body involved. Patient feels fine except for pain in shoulder. Phoned family physician for patient, and requested that she be seen. Physician did not believe it was a serious reaction and that swelling would subside soon.									U	10/09/2007	10/10/2007	1		UNK	PVT						1						1	Erythema; Injection site pain; Injection site swelling; Musculoskeletal pain; Pain in extremity	FLU3~SANOFI PASTEUR~U249AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0292771	10/11/2007	VA	40.0	40		F	10/11/2007	Swollen sore red and hot to touch.  Baseball sized red swollen area around site of injection. Fever of 101 degrees for two days, sweats and chills				Y					U	10/08/2007	10/10/2007	2		UNK	UNK	Zithromax, Claritin	sinus infection	congenital heart disease- repaired anuerysm of the sinus of valsalva, bicuspid aortic valve, allergies to:PCN,Sulfa, percocet,darvocet,compazine,codeine,vicodin			1						1	Chills; Erythema; Hyperhidrosis; Injection site erythema; Injection site swelling; Pain; Pyrexia; Skin warm; Swelling	FLU3~SANOFI PASTEUR~U2491AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0985F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0292773	10/11/2007	GA	74.0	74		M	10/11/2007	severe local reaction after 24 hours, patient's right arm was red, swollen and extremely sore,patient to take diphenhydramine and go to ER if have SOB, patient went to MD and got RX(unknown) and he is doing much better, swelling is almost gone				Y					Y	10/09/2007	10/10/2007	1		UNK	UNK						1						1	Erythema; Local reaction; Oedema peripheral; Pain in extremity; Erythema; Local reaction; Oedema peripheral; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua303ba~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0038u~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA303BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~2|PPV~MERCK & CO. INC.~0038U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0292775	10/11/2007	TX	66.0	66		F	10/11/2007	Patient has developed multiple raised bumps on the right arm from elbow to shoulder, as rash.  Have recommend to take benadryl or claritin for the allergic reaction.									U	10/11/2007	10/11/2007	0	none	UNK	UNK		no	none			1						1	Hypersensitivity; Rash	FLU3~SANOFI PASTEUR~u2445aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0989u~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0292776	10/11/2007	OH	61.0	61		M	10/11/2007	chills, sweats, shakes, fever (101), hives, headache.  Shot received 5:00 PM Thursday, October 4, 2007. Symptoms appeared the following day, Friday, October 5, 2007 and progressed into the Friday evening when symptoms reach maximum and Saturday by 10 am, disappeared, except for the mild hives on my right shoulder which have remained									Y	10/04/2007	10/05/2007	1		UNK	PVT	vytorin; welchol; synthroid; aspirin; niacin; omega fish oil; fiber supplement; calcium supplement; multi vitamin	none	allergy - flagyl; latex; medical conditions = heart disease; undifferentiated mixec connective tissue disease			1						1	Chills; Headache; Hyperhidrosis; Pyrexia; Tremor; Urticaria	FLU3~SANOFI PASTEUR~u2u92aa~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~0303u~1~SC~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0292777	10/11/2007	NC	57.0	57		F	10/11/2007	I was given the vaccine & within 30min.I began having trouble breathing.I used my Xopenex inhaler & took 25mg Benadryl PO.I was also given Epi 0.3mg SQ via Epi-Pen.The reaction continued to progress & I was taken to the ED.There I was given another dose of Epi,2 more Xopenex resp.treatments,120 mg Sol-U-Medrol IV & placed on Bi-Papp.I was also give 60mg of Prednisone PO & another 60mg PO to be taken today.I was released from the Ed 5.5hr.later.Today I remain unable to speak above a whisper.ED doctor notifed my primary MD & I notifed my Pulmonary MD today.				Y					Y	10/10/2007	10/10/2007	0		UNK	UNK		none	Allergy to: Sulfa including sulfites & sulfonamides,Augmentin,Betadine/Iodine,All cillin drugs,Morphine. Also dx.with Migranes			1						1	Dysphonia; Dyspnoea	FLU3~SANOFI PASTEUR~U2439AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0291678	10/12/2007	CT	1.6	1	.6	M	10/11/2007	Information has been received from a police officer who heard about a report through a fellow officer of a 14 month old male child with a history of at least one seizure who on 24-SEP-2007, was vaccinated with ProQuad or MMR II alone. The patient was put to bed on the night of 24-SEP-2007, and in the morning of 25-SEP-2007, the child passed away and was found face down on the bed. It was indicated that there was no reported suspicion of foul play, but per police department protocol, the case and case file had been transferred to a local detective for investigation. An autopsy is to be performed per police report. The reporter was not involved in the case, but did review the case file out of interest because he has a child of his own the same age as the child involved in this report. A product quality complaint was not reported. No further information was available. Additional information has been requested.	Y	09/25/2007							N	09/24/2007	09/25/2007	1	Unknown	OTH	OTH	Unknown		Convulsion		WAES0709USA04443	1						2	Death	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B056CA~4~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2456BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0700F~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0823U~1~SC~RA~VARICELLA (VARIVAX)~1|MMR~MERCK & CO. INC.~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~2|VARCEL~MERCK & CO. INC.~~UNK~UN~UN~VARICELLA (VARIVAX)~2	USA	Results in Death	Influenza
0292894	10/12/2007					F	10/12/2007	We received on 05 OCT 2007 from a nurse the following information: A female patient (birthday unknown) was vaccinated with Fluvirin, batch no. 78480 on an unknown date. She developed an anaphylactic reaction on 03 OCT 2007. The outcome is unknown. Company assessment: Seriousness criterion: medically significant. Causality: possible. Expectedness assessment according to SPC: Anaphylactic reaction is expected after vaccination with Fluvirin. No change in benefit risk-ratio. No measures necessary.									U		10/03/2007			OTH	OTH	No other medications	Unknown			ma20071077	1						1	Anaphylactic reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0292907	10/12/2007	WI	30.0			M	10/13/2007	Tachycardia HR 100-92 bpm, blood pressure 148/96, Impending feelings of doom.									N	10/13/2007	10/13/2007	0		MIL	MIL						1						1	Blood pressure; Feeling abnormal; Tachycardia	FLUN3~MEDIMMUNE VACCINES, INC.~800488P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0292908	10/12/2007	WA	52.0	52		F	10/11/2007	Swelling at injection site - firm at the size of a baseball. Pain, welts, and low grade fever. Approximately 6-8 hours after injection. Prednisone 40 mg x 5d q 6 and Ranitidine 150mg BID, Benadryl 25-50 mg q 6, Hydromorphine 2mg PRN prescribed by ER doctor.				Y					Y	10/09/2007	10/09/2007	0		OTH	PUB	VICODIN, DIAZEPAM, ZOLIPIDEM, GABAPENTIN, LEXAPRO, METHOCARBAMOL					1						1	Injection site induration; Injection site swelling; Pain; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U2463AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0061U~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0292909	10/12/2007	TX	76.0	76		M	10/09/2007	Patient left pharmacy and went to an assisted living complex to see someone. He then experienced dizziness, sweating and fatigue. Nurses took his vitals and glucose levels. All were normal. Symptoms resolved 30 minutes after with no treatment. Patient returned to pharmacy to inform me of event. Patient was of even temperament.									Y	10/03/2007	10/03/2007	0		OTH	OTH						1						1	Dizziness; Fatigue; Hyperhidrosis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA311BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0292910	10/12/2007	OR	40.0	40		F	10/11/2007	Lethargy, fatigue, flu-like symptoms headache, temperature > 102 F, rash over upper body, swelling and pain at injection site of Pneumovax.				Y					U	10/08/2007	10/09/2007	1		OTH	OTH	ALTACE, METOPROLOL, NASACORT, CLONZEPAM, ZOLPIDEM	None	Osteopenia, Insomnia, Hypertension			1						1	Body temperature increased; Fatigue; Headache; Influenza like illness; Injection site pain; Injection site swelling; Lethargy; Rash; Erythema; Headache; Injection site pain; Injection site swelling; Laboratory test normal; Myalgia; Pyrexia; Rash; Red blood cell sedimentation rate increased; Skin warm; Urticaria; White blood cell count increased	FLU3~SANOFI PASTEUR~U2888AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0962U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U2488AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0962U~1~UN~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0292912	10/12/2007	TX	77.0	77		F	10/12/2007	Patient received vaccination on 10/10/07 had redness and swelling on 10/11/07 and saw her ENT. Her ENT told her that if it got worse she would need to call doctor on 10/12/07 we referred her to ER.				Y					U	10/10/2007	10/11/2007	1		PVT	OTH		None	None			1						1	Erythema; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLA039AA~4~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1132U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0292913	10/12/2007	VA	31.0	31		M		Painful conjucta, eye swollen, red, and + discharge.									Y	10/10/2007	10/10/2007	0		MIL	MIL	AMBIEN					1						1	Eye discharge; Eye pain; Eye swelling; Ocular hyperaemia	FLUN3~MEDIMMUNE VACCINES, INC.~500488P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0292914	10/12/2007	WA	66.0	66		F		Increase red, swell, pain left arm erythema left lateral axillary node rx with antibiotics.				Y					U	10/10/2007	10/11/2007	1		OTH	UNK		None	Not to vaccine			1						1	Erythema; Oedema peripheral; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~80827~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1005F~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0292915	10/12/2007	OR	44.0	46		F	10/12/2007	Vaccinated on 10/9/07. One day after patient had soreness at the site and down into armpit area with swelling in front of armpit area. Patient taking IBU, is better, patient notified us this date, 10/12/07.									U	10/09/2007	10/10/2007	1		OTH	OTH	ATENOLO, ALBUTEROL	None	None			1						1	Injection site pain; Swelling	FLU3~SANOFI PASTEUR~U2453A~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0962U~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0292916	10/12/2007	FL	0.55	0	.5	F	10/12/2007	The flu vaccine given on 10-12-07 at 10am was 0.5ml and should have been 0.25 ml. No signs or symptoms - no treatment required.									U	10/12/2007	10/12/2007	0	None	PVT	PVT		None	None			1						1	Incorrect dose administered	DTAP~SANOFI PASTEUR~C2762AA~3~~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2501AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF21BAC~3~~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B70143C~3~~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1052U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0292917	10/12/2007	MD	51.0	51		F	10/12/2007	Coughing, itching, eye lids swollen				Y					Y	10/12/2007	10/12/2007	0		PUB	PVT	None	None	Aleve, PCN			1						1	Cough; Eyelid oedema; Pruritus	FLU3~SANOFI PASTEUR~U245LAA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0292931	10/12/2007	MI	2.0	2	.3	F	10/12/2007	Patient was given the influenza virus vaccine.  After administration, a nurse noticed that the patient's parents were not asked about allergies, specifically an egg allergy.  The patient was kept in the exam room for 10 minutes, after which a small welt at the injection site was noted.  The patient was moved to a treatment room for further observation.  Diphenhydramine was administered through the patient's G-tube and ice was applied to the injection site.  Patient rapidly and fully recovered									Y	10/08/2007	10/08/2007	0		PUB	UNK	Isradipine 1 mg /ml compounded 1 mg PO PRN BP > 110/70 (up to every 4 hours)   Labelatol  100 mg (40 mg/ml) PO  BID            NaCl 4 mEq/mL 105 mEq PO  Daily add to 70 oz formula   NaHCO3   (1mEq/ml)  48 mEq  PO  Daily         add to 70 oz	1. Chronic renal insufficiency (grade 3) with hypertension,              polyuria, salt-wasting           2. Spastic quadriplegic cerebral palsy           3. Microcephaly with global developmental delay           4. Sensorineural hearing loss	Egg (hives); seasonal; animal dander			1						1	Injection site reaction; Urticaria	FLU3~SANOFI PASTEUR~~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0292932	10/12/2007	MD	72.0	72		F	10/12/2007	Client went to our flu clinic on 10-11-07, was vaccinated with injectable flu vaccine using the Biojectat approx. 5:30 -6:00 pm. She stated that she felt fine and went to bed at 11:00 pm. She stated she woke up at about midnignt with severe itching on  top of her  right thigh and both elbows, she also had welts.  SHe stated she did take a Benadrl that was expired and used wet cold cloths to soothe the areas. She eventually went back to sleep and woke up this morning and the welts and itching are gone and she feels better.									Y	10/11/2007	10/11/2007	0		UNK	UNK	taking Vedilol 3.125 mg BID,just startedthis 2 weeks ago, and antiviral med OQ, tylenol w/codiene	Was treated with a nerve block in her neck at Hospital on WED. 10-10-07	Hx of leaking heart valve, Herpes virus in eye, Hx of corneal transplants,Chronic neck pain d/t car accident			1						1	Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79897~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0292936	10/12/2007	TX	72.0	72		M	10/12/2007	About 10 hours after getting the shot, I had a 100.2 deg temp, the chills, and violent vomiting. About 3 hours later, another bout of violent vomiting. The next morning, vomiting returned about 8am after drinking some juice. My wife had the same shot at the same time, our diet was the same, and she had no adverse effects.									Y	10/11/2007	10/11/2007	0	None	UNK	UNK		None				1						1	Body temperature increased; Chills; Vomiting	FLU3~SANOFI PASTEUR~U2510AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0292941	10/12/2007	NH	21.0	21		F	10/12/2007	ON 2 OCT 2007, PT RECEIVED DOSE #1 OF ANTHRAX VACCINE (SUB q) IN THE RIGHT UPPER DELTOID REGION. STATES SHE HAD A HEADACHE THAT AFTERNOON. PT STATES THAT THE INJECTION SITE HURT (LEVEL 5 ON THE PAIN SCALE) FOR 5 DAYS. THERE WAS A SMALL HARD LUMP, IT BACAME ITCHY (PT RUBBED, DID NOT SCRATCH THE SITE). SITE STARTED TO LOOK LIKE A RASH. SHE APPEARS TODAY WITH A 50mm X 40mm swollen, reddened raised welt region on her arm. SHE WAS SEEN TODAY BY NP, PRESCRIBED CLARITIN. PT DENIES BREATHING, WEAKNESS, PALENESS, OR SWELLING DIFFICULTIES.				Y					Y	10/02/2007	10/03/2007	1	NONE	MIL	MIL	NONE	NONE	NONE	NONE~ ()~~0.00~Patient		1						1	Headache; Injection site induration; Injection site pain; Injection site pruritus; Injection site rash; Swelling; Urticaria	ANTH~EMERGENT BIOSOLUTIONS~FAV110~1~~~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~AFLUA282EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0292942	10/12/2007	OH		0	.0	F	10/12/2007	This is a newborn (10/3/07) WF by emergency C-section that received a single dose of Fluarix (lot AFLUA302BA exp 6/30/08) on 10/5 instead of Engerix B (the syringes look alike). The error was discovered on 10/9. The patient was treated with IV genatmicin and ampicillin from days one through three to rule out sepsis. Blood cultures were negative and the patient was discharged on 10/6. The patient was brought in for a baby check on 10/8/07. She appeared lethargic, jaundiced and dehydrated. She had bouts of apnea with cyanosis. She was given fluids and electrolytes and transferred to Children's Medical Center. The patient expired on 10/10/07. The initial impression is enteral viral sepsis without a definitive cause at this point. Cause from the flu vaccine is doubtful but unknown.  10/16/07 T/C to reporter who provided patient demographics.  10/18 Linked w/293414./ss 10/26/07 Hospital medical records including vax record reviewed which reveal lot number correct as reported.  D/C to home 10/6 with f/u scheduled for 10/8.  11/13/07 Received hospital medical records which reveal patient experienced poor feeding & apnea/cyanosis events at home.  Lethargic w/multiple apneic events at pcp office on 10/8/07.  WBC 16.8, platelets 20,000 in pcp poffice.  Pcp placed on O2 & called EMS.  Blood c/s done & IV antibiotics given. Admitted 10/8-10/10/2007.  Admit exam revealed overriding sutures, irritable with minimal suck & response to pain. Had multiple apneic & bradycardic episodes & was intubated.  Unable to convert SVT, blood pressure dropped, expired. 11/13/07 Received autopsy report with hospital records which states COD as myocarditis; massive acute hemorrhage, liver; meningitis; extensive lung hemorrhages, bilateral pneumonia & pleural effusions.	Y	10/10/2007							N	10/05/2007			10/8 CXR negative LABS: echocardiogram.  EKG revealed SVT.  Troponin 36.8.Liver enzymes (H).  Bilirubin 12.2.  H/H 9.7/27.8. D-dimer (+).  Transfused w/PRBCs & FFP.	UNK	UNK	As in narrative.	newborn, rule out sepsis.	Birth Hx: 35 wk, c-section due to maternal pain.  Nuchal cord at birth & vacuum extraction.  Apgar scores were 3/6/8 at 1/5/10 minutes.  Patient cyanotic & lethargic at birth.			1						1	Chest X-ray normal; Cyanosis neonatal; Death; Dehydration; Infantile apnoeic attack; Jaundice neonatal; Lethargy; Sepsis; Wrong drug administered; Apnoea; Autopsy; Death; Medication error; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA302BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3028A~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Results in Death	Influenza
0292945	10/12/2007	PA	21.0	0	.0	F	10/12/2007	Pt. stated her right arm was swollen with an area of redness about 3 inches in diameter. Now has some red areas on her back with itching, which she thinks are hives.									Y	10/10/2007	10/12/2007	2		PUB	PVT	Birth Control	NONE	Penicillin			1						1	Erythema; Oedema peripheral; Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA309CA~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0292947	10/12/2007	NY	56.0	56		F	10/12/2007	Pt was administered the flu vaccine at 1:40 pm on 10/11/07. Pt reported following flu vaccine swollen lips and chest tightness. In addition, a diffuse rash appeared over his body that was itchy, pink and papular.									Y	10/11/2007	10/11/2007	0		PVT	UNK	Ambien 10mg Tablet Take 1 tablet(s) by mouth at bedtime prn  Spironolactone 25mg Tablet Take 1 tablet(s) by mouth daily  Altace 2.5mg Capsules Take 1 capsule(s) by mouth daily  Norvasc 2.5mg Tablet Take 1 tablet(s) by mouth daily  Vicodin E	presented with joint swelling and shoulder pain	alcoholic cirrhosis, lymes dx, hepatitis C, major depressive disorder, insomnia, essential hypertension			1						1	Chest discomfort; Erythema; Lip swelling; Rash papular; Rash pruritic	FLU3~SANOFI PASTEUR~U2501AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0292948	10/12/2007	CA	67.0	67		F	10/12/2007	Vaccine administered SQ left triceps area on 10/10/07.  On 10/12/07 patient awakened with tender red area 4 long.  I examined her on 10/12 and felt it was not infected and advised treatement with ice and to call if any worse				Y					U	10/10/2007	10/12/2007	2	none	UNK	UNK						1						1	Erythema; Incorrect route of drug administration; Tenderness	FLU3~SANOFI PASTEUR~U2436A~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0032U~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0292952	10/12/2007	NJ	75.0	75		F	10/12/2007	Tongue swelling, shortness of breath began about 1-2 hours after administration of Zostavax and Fluvirin. Patient took Benadryl and was told to call 911 and go to ER.  In ER was given Benadryl and steroids.				Y					Y	10/02/2007	10/02/2007	0	none	PVT	PVT	Pravachol, Evista, Levoxyl, Ventolin inhaher prn, Pepcid AC prn, Albuterol neb prn, Advair 250/50, Singulair, Calcium/Vit. D	mild wheezing near time of administration, but none at time of admininistration	asthma, hypothyroidism, hypercholsterolemia, hypertension, osteoporosis			1						1	Dyspnoea; Swollen tongue	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79721~7+~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARZOS~MERCK & CO. INC.~08860~1~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0292956	10/13/2007	CA	82.0	82		F	10/13/2007	Presented 10/12/07 complaining of itchy, generalized vesicular rash which started about 2 weeks prior.				Y					U	09/20/2007	09/28/2007	8		PVT	PVT	metformin, premarin, folate, rhythmol, lipitor, diltiazem, paxil, aspirin, nexium, iron, vitamins	anemia	hyperlipidemia, hypertension, diabetes, paroxysmal atrial fib,			1						1	Pruritus; Rash generalised; Rash vesicular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80684~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARZOS~MERCK & CO. INC.~0886u~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0292957	10/13/2007	CA	79.0	79		F	10/13/2007	Presented to office 10/12/07 complaining of severe left shoulder pain which started around 10/6.  Blisters on arm appeared 10/8 in dermatomal pattern.  Diagnosis:  shingles.  Treated with Valtrex 1000mg tid for 7 days and pain medication.				Y					U	10/04/2007	10/06/2007	2		PVT	PVT	lotrel, hctz, pravastatin, boniva, coQ-10,  aspirin, vitamins, calcium	none	hypertension, sciatica, djd, hypercholesteremia, osteopenia			1						1	Blister; Herpes zoster; Musculoskeletal pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80957~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0292958	10/13/2007	VA	14.0	14		F	10/13/2007	C/O Pain in frontal sinus onset approximately five (5) minutes after adminstration of FluMist.  Reported the symptoms at 1150 and at this time symptoms at on and off.									Y	10/13/2007	10/13/2007	0	N/A	MIL	MIL						1						1	Sinus headache	FLUN3~MEDIMMUNE VACCINES, INC.~500483P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0292959	10/13/2007	NY	46.0	46		F	10/13/2007	5-10 minutes after receiving influenza (Fluzone) vaccine, pt c/o throat swelling. Epi and Benadry administered. O2 administered. Transferred to ED.				Y					Y	10/13/2007	10/13/2007	0		PVT	PVT	Benicar/HCTZ	None	allergies: Iodine, provera, premarin, amoxicillin   Medical History: pituitary tumor, migraines, HTN, GERD			1						1	Oxygen supplementation; Pharyngeal oedema	FLU3~SANOFI PASTEUR~U2446AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0292962	10/13/2007	TX	4.0	4		F	10/13/2007	Redness and swelling on her left arm where she received the shot.									U	10/12/2007	10/13/2007	1		PVT	PVT						1						1	Injection site erythema; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0292963	10/13/2007	CA	64.0	64		M	10/13/2007	Fever to 99.9  total body ache of muscles from 3 hours following shots of both flu and pneumonia  on 10/11/07 to 5:00 am 10/13/07. Wife who had just flu shot felt none of these sysmptoms.									Y	10/11/2007	10/11/2007	0		UNK	PVT	Diltiazem XR 240 mg., Vytorin 10/20, Omeprazole DR 20 mg, Spiriva 18 meq., Benazepril HCl 10 mg., Asprin 1 tab, Vitamin E.	None	allergic to Darvocet N			1						1	Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0292964	10/14/2007	IA	1.33	1	.4	F	10/14/2007	FEVER, REDNESS AND SWELL AT AND BELOW INJECTION SITE				Y					Y	10/12/2007	10/13/2007	1	NONE	PVT	PUB	NONE	NONE	NONE			1						1	Injection site erythema; Injection site swelling; Pyrexia	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B049AA~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2460CA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB141AA~3~IM~LL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~B54013C~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0292965	10/14/2007	IN	20.0	20		M	10/14/2007	Patient experienced swollen arm and fingers, hives, itching, and numbness in fingertip in the arm in which vaccine was injected. Symptoms were delayed onset and happened in approximately 20 hours after vaccination administration. There were no signs of inflammation at the injection site itself in the deltoid muscle. Patient attended a immediate care facility and received medrol dose pack and diphenhydramine treatment for his symptoms.				Y					Y	10/13/2007	10/14/2007	1	N/A	PUB	PVT	N/A	None	None			1						1	Hypoaesthesia; Oedema peripheral; Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80824~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0292967	10/14/2007	IA	1.17	1	.3	F	10/14/2007	LEFT THIGH 1.5CM INDURATION AT SHOT SIGHT,  RED AND PURPLE BRUSE INNER L THIGH				Y					Y	10/11/2007	10/13/2007	2	NONE	PVT	PVT	ZITHROMAX	NONE	NONE			1						1	Contusion; Injection site induration; Skin discolouration	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B061BB~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2456AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB162DB~1~IM~RL~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0292968	10/14/2007	TX	61.0	61		F	10/14/2007	ALL DAY SATURDAY RAN 102 FEVER, ALSO ARM SO HEAVY AND HURTING FROM RIGHT ABOVE ELBOW TO UP ON SHOULDER.  ON SUNDAY STILL RUNNING LOW GRADE FEVER OF 99.9 AND ARM STILL SORE AND RADIATING HEAT.									U	10/12/2007	10/13/2007	1	NONE	UNK	PVT		NONE	SULPHUR			1						1	Pain in extremity; Pyrexia; Sensation of heaviness; Skin warm	FLU3~SANOFI PASTEUR~U2457AA~5~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0803(U OR 11)~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0292972	10/14/2007	AR	57.0	57		M	10/14/2007	ON 9/27/07 1145 RECEIVED VACCINE WHILE AT DAILYSIS CENTER AT 1730 WIFE NOTICED WHELPS DEVELOPED ON PATIENT FACE THAT WORSEN AND THEN GEGAN TO RESOLVE NEAR 2000, RESOLVED ON SKILL NURSE VISIT 9/28/07									Y	09/27/2007	09/27/2007	0	NA	UNK	UNK	MULTIPLE	NA	ESR	NA~ ()~NULL~~In Patient		1						1	Renal failure chronic; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLAO37AA~3~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0292773	10/15/2007	GA	74.0	74		M	10/11/2007	Severe local reaction after 24 hours, patient's right arm was red, swollen and extremely sore, patient to take diphenhydramine and go to ER if have SOB, patient went to MD and got RX (unknown) and he is doing much better, swelling is almost gone.				Y					Y	10/09/2007	10/10/2007	1		OTH	OTH						1						2	Erythema; Local reaction; Oedema peripheral; Pain in extremity; Erythema; Local reaction; Oedema peripheral; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua303ba~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0038u~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA303BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~2|PPV~MERCK & CO. INC.~0038U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0293054	10/15/2007		1.75			F	10/12/2007	Initial information received on 02 October 2007 from another manufacturer, report number WAES0708USA05829. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: Information has been received from a registered nurse concerning six patients who were vaccinated with Varivax (Oka/Merck). Subsequently, the patients experienced breakthrough chickenpox. A product quality complaint was not involved. Follow-up received 20-SEP-2007: Follow-up information has been received from a registered nurse concerning a 21-month-old female with no pertinent medical history or allergies who on 20-JAN-2007 was vaccinated in her left thigh with her first dose of ProQuad (Oka/Merck upgrade process) (lot # 656165/1387F). It was unknown if there were any illnesses at the time of vaccination. On 20-JAN-2007 concomitant vaccines included fourth dose of Trihibit (Sanofi Pasteur) (Lot # V1465AA & VE959AA), a fourth dose of (Prevnar) (Wyeth) (Lot # B08684A), and first 0.25 mg dose of influenza virus vaccine (unspecified) (Sanofi Pasteur) (Lot # UT2176JA). On 18-AUG-2007 the patient developed numerous lesions on her face. The patient was prescribed with acyclovir (ZOVIRAX) 200mg-5 mL three times a day for 5 days. The patient recovered from the adverse event at an unspecified date. The event was considered to be an other important medical event by the reporter. It was noted that the patient's sibling (WAES # 0709USA03345) experienced an adverse event. This is one of several reports from the same source. Additional information has been requested. Tripedia lot numbers reported as V1465AA and VE959AA are not valid sanofi pasteur lot numbers.				Y					Y	01/20/2007	08/18/2007	210		UNK	UNK					200703320	1						1	Skin lesion; Varicella	DTAP~SANOFI PASTEUR~V1465AA~4~UN~UN~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT2176JA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~VE959AA~4~UN~UN~HIB (ACTHIB)~1|MMRV~MERCK & CO. INC.~1387F~1~UN~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B0B684AA~4~UN~UN~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0293056	10/15/2007	MI	71.0	71		F	10/11/2007	Initial information received from a health care provider on 07 October 2007. A 71-year-old female patient received a dose of Fluzone SV 2007-2008, lot number unknown, on 04 October 2007 at 10:00 AM. The route and site of administration were not reported. Thirteen minutes post-vaccination, the patient fainted. Her blood pressure was 188/90. The patient's medical history included non-insulin dependent diabetes mellitus and hypertension. Following the event, the patient was taken to the emergency room and was discharged. It was not reported whether the patient received any treatment or whether any laboratory testing was completed. The patient's recovery status is unknown.				Y					U	10/04/2007	10/04/2007	0		UNK	UNK	UNSPECIFIED HYPERGLYCEMIC MEDICATION		The patient had a history of non-insulin dependent diabetes mellitus and hypertension. She had no known allergies. As per the reporter, the patient was a poor historian.		200703408	1						1	Blood pressure increased; Syncope	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293057	10/15/2007	CA	54.0	54		M	10/11/2007	Initial report received on 09 October 2007 from the patient.  54-year-old male patient, with no illness at the time of vaccination, had received a first dose, left deltoid, intramuscular injection of Adacel, lot number unknown; and a second dose, right deltoid, intramuscular injection of Fluzone SV 2007-2008, lot number unknown; on 01 October 2007. Three days post-vaccination, the patient experienced swelling of his fingers, mouth, throat, and tongue. He had no shortness of breath. He was examined by a physician four days later, and the swelling had decreased although his feet, arms, and mouth were still swollen. The patient was treated with cortisone and was to follow-up with an allergist. Relevant diagnostic testing was none. At the time of this report, the patient had not recovered.				Y					N	10/01/2007	10/04/2007	3		UNK	UNK			The patient had no illness at the time of vaccination, had no past medical history, and was on no other medications.		200703409	1						1	Dyspnoea; Oedema mouth; Oedema peripheral; Pharyngeal oedema; Swollen tongue	FLU3~SANOFI PASTEUR~~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~~1~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0293093	10/15/2007	CO	49.0	49		F	10/05/2007	Information has been received from a Register Nurse (R.N.) concerning a 49 year old female patient who on 22-SEP-2007 was vaccinated subcutaneous into the left arm with a dose of Pneumovax 23 Lot #657143/0380U. Concomitant therapy included DTaP (unspecified) and influenza virus vaccine (unspecified), both vaccines were given in the right deltoid, On 24-SEP-2007 the patient called stating she had a fever all weekend, was vomiting, and developed a hand sized redness which started at the injection site of left arm travelling downward. She mentioned that the injection site was hot to touch. She was taking (Advil) and (Tylenol). The nurse called the patient on Tuesday morning as a follow-up. Patient told the nurse she was feeling terrible, and it was recommended she go to the Community Medical clinic. Tuesday, 25-SEP-2007 she went to the clinic. Her temperature was down and her white blood count was within normal limits. No blood cultures drawn. Patient was treated with Intravenous (IV) antibiotics and then released. On Wednesday, 24-SEP-2007 patient went back to the clinic, complaining her stomach was hurting and feeling achy over her body. She was treated with IV antibiotics and 2 liters of IV fluids and then released. On Thursday, 27-SEP-2007 client went to clinic, treated with IV antibiotics and released. It was reported that she would get IV antibiotics treatment on 28-SEP-2007 at the clinic. Physician at the clinic diagnosed client with stph infection, but no blood cultures were drawn. Patient was also treated with oral antibiotics (the names of the therapy was unspecified). Patient told the nurse that she was off due to the symptoms. As of this reports day the client had not recovered. The reporter indicated that the patient's adverse events fever, stomach hurting, feeling terrible, feeling achy all over her body and vomiting and being diagnosed having saph infection were disabling. The reporter also felt that getting IV antibiotics, IV fluids was an intervention to prevent a serious criteria and it was reported as an other medical event. Additional information has been requested.				Y				Y	N	09/22/2007	09/24/2007	2	WBC count 09/25/07 - Normal	OTH	OTH			Unknown		WAES0710USA00063	1						1	Abdominal pain upper; Fluid replacement; Inappropriate schedule of drug administration; Injection site erythema; Injection site warmth; Malaise; Pain; Pyrexia; Staphylococcal infection; Vomiting; White blood cell count normal	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~RA~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0380U~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0293098	10/15/2007	NJ	4.0	4		M	10/15/2007	Seen in our office on 10/9/07 for 4 year old WCU.  Rec'd DTAP, MMR, IPV, and Influenza.  Woke up on 10/11/07 with left arm slightly swollen, red,and warm to touch.  Progessivly got worse seen again in our office and diagnosed with post vaccine local reaction with cellulitis.  Treated with Keflex and Benadryl.				Y					Y	10/09/2007	10/11/2007	2	None	PVT	PVT	Multi-Vitamin	None	None			1						1	Cellulitis; Injection site erythema; Injection site swelling; Local reaction; Skin warm	DTAP~SANOFI PASTEUR~C2765AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2500AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0170~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~3088U/0748U~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0293100	10/15/2007	MA	44.0	44		F	10/15/2007	in the evening, after vaccination with influenza and PPV-23, the patient developed fever and chills. she also developed redness and swelling at the site of the PPV-23 (right arm, SQ inf to delt). She missed one day of work. She is recovering; no more fever or chills, erythema is diminishing. Appears patient is recovering.				Y					Y	10/11/2007	10/11/2007	0	N/A	PUB	PUB	glipizide, lovastatin	had had a mild URI the week before	med con: diabetes, elev chol           allergies: benadryl, glucophage, doxycycline			1						1	Chills; Injection site erythema; Injection site swelling; Pyrexia	FLU3~SANOFI PASTEUR~U2490AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1229F~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0293103	10/15/2007	FL	69.0	69		F	10/15/2007	The day after receiving flu shot, felt like hit by sledge hammer - achy and tired feeling - spent whole day on couch, dozing off and on - no appetite; severe headache with pain behind right eye.  Symptoms lasted one day.									Y	10/08/2007	10/09/2007	1	None	UNK	PUB	Zoloft, Zocor, multivitamin, vitamin C, vitamin B complex, calcium + vitamin D & magnesium.	None	Allergy to iodine dye; history of breast cancer; depression; hypercholesterolemia.			1						1	Anorexia; Eye pain; Fatigue; Headache; Pain	FLU3~SANOFI PASTEUR~U2457AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293105	10/15/2007	TX	2.0	2	.4	M	10/15/2007	severe vomiting occured approximately 20 to 30 minutes after flu shot was administered.  Vomiting continued for approximately 8 hours.									Y	10/12/2007	10/12/2007	0		PVT	PVT	Pediox	congested	none			1						1	Vomiting	FLUX~UNKNOWN MANUFACTURER~unk~2~UN~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0293106	10/15/2007	DC	54.0	54		F	10/15/2007	Supraclavicular adenopathy and tenderness with soft tissue swelling on same side vaccine was administered.  Axillary adenopathy on same side as vaccine.  No fever, no malaise, no angioedema.  Site of vaccine administration appeared clear without evidence of infection.									U	10/10/2007	10/11/2007	1		UNK	UNK						1						1	Lymphadenopathy; Swelling; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78994~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0293109	10/15/2007	GA	62.0	62		M	10/15/2007	Patient has swelling of the left arm along with redness and tightness of the muscle. Also, a rash has developed on the side of the torso.  Symptoms and signs appeared within 24 hrs. of the vaccination.									U	10/13/2007	10/14/2007	1		UNK	PVT	N/A	N/A	N/A			1						1	Erythema; Muscle tightness; Oedema peripheral; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua303ba~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1344u~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293110	10/15/2007	TX	10.0	10		F	10/15/2007	Sustained fever for 3 days, 102 average, 103.1 at peak, sore throat, fatigue				Y						10/11/2007	10/12/2007	1		PVT	PVT		None	None			1						1	Fatigue; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~unknown~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0293112	10/15/2007	MA	61.0	60		M	10/15/2007	Administered vaccine and immediatly his where I injected became like a hard ball.  Swelled, hard nodule.  No treatment.  Monitored pt.									Y	10/11/2007	10/11/2007	0	n/a	PUB	UNK	Coumadin	None				1						1	Immediate post-injection reaction; Injection site induration; Injection site swelling; Nodule	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU280Da~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0293113	10/15/2007	MA	48.0	47		F	10/15/2007	Patient complained of the shakes and anxiety after vaccination.									Y	10/12/2007	10/12/2007	0	n/a	PUB	UNK	unknown	Anxiety				1						1	Anxiety; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLuA280Da~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0293115	10/15/2007	PA	31.0	31		M	10/15/2007	Received flu vaccine on 10/12/07 around 1:45pm. On 10/13/07 around 4 pm noticed back itching. The next morning 10/14/07 noticed hives under arms, on chest and uppr abdomen and itching of entire torso and groin. He went to the emergency room around 4pm because of intensity of symptoms and received a shot of prednisone and a prescription for oral prednisone.				Y					Y	10/12/2007	10/13/2007	1		UNK	PVT		none	None			1						1	Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA 316BA~3~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0293118	10/15/2007	UT	60.0	60		F	10/15/2007	Vaccination given on left arm 1 above smallpox vaccination scar. 1/2 hr after injection, area around smallpox scar raised, red, & warm to touch. 2 days later, area still (1-1/2 diameter) red, warm & tender to touch. Is the smallpox vaccination scar related to this?									Y	10/13/2007	10/13/2007	0		UNK	UNK	Actonel, Armour Thyroid, Imitrex		Hypothyroid, Ostopenia/osteoporosis, migraine headaches			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Scar	FLU3~SANOFI PASTEUR~49281-0380-15~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293119	10/15/2007	MN	74.0	74		F	10/15/2007	SWELLING AND WARMTH AROUND GIRTH OF RIGHT ARM, STARTED THE DAY AFTER VACCINE ADMINISTERED				Y				Y	Y	10/09/2007	10/10/2007	1		UNK	UNK	LIPITOR, DI0VAN, ACTONEL, GEMFIBROZIL, ASPIRIN, CALCIUM, FOLIC ACID, MULTIVITAMIN, TYLENOL ARTHRITIS, PEPTO BISMOL, ZETIA	NONE	HYPERTENSION, HYPERLIPIDEMIA, MENOPAUSE, COLLAGENOUS COLITIS, OSTEOPOROSIS			1						1	Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U2452AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0486U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0293120	10/15/2007	TX	60.0	60		M	10/15/2007	Patient received influenza vaccine at 1105 AM 10/15/2007 and was found asystolic and unresponsive in the parking lot at 1138 AM.  Resuscitative efforts were unsuccessful.	Y	10/15/2007							N	10/15/2007	10/15/2007	0	none	PUB	UNK	unknown	unknown; code team contacted his supervisor who reports that he was well the morning of 10/15/2007.	unknown			1						1	Cardiac arrest; Death; Resuscitation; Unresponsive to stimuli	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA300BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Results in Death	Influenza
0293121	10/15/2007	TX	53.0	53		F	10/15/2007	approximately 6 hours after shot,arm very swollen and sore started getting chills, fever, headache felt nauseaus and felt kind of dizzy, chills got worse within couple hours and breating labored, also heartbeat very rapid this lasted for about 7 hours before finally subsiding into slight congestion low grade fever and runny nose and arm still a little sore									Y	10/11/2007	10/11/2007	0		UNK	PUB			Diabetes, Hepatitis C			1						1	Chills; Dizziness; Dyspnoea; Headache; Heart rate increased; Nausea; Oedema peripheral; Pain in extremity; Pyrexia; Respiratory tract congestion; Rhinorrhoea	FLU3~SANOFI PASTEUR~U2510AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293123	10/15/2007	TX	77.0	77		M	10/15/2007	Pt called 10/15 to complain of flattened red itchy itch rash that started around 10/12-13/07 on tops of arms and has spread to abdomen & chest areas as well.  Has not been seen by usual health care provider yet but has appt later in the week.  Pt feels is related to flu shot though he gets them annually and has never had reaction before.									U	10/10/2007	10/13/2007	3	none yet	UNK	UNK	none known	none stated	claims pcn allergy & codeine sensitivity			1						1	Drug hypersensitivity; Rash erythematous; Rash pruritic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78991~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0293127	10/15/2007	UT	21.0	21		F	10/15/2007	Nausea, fever, achyness, weakness, headache									Y	10/11/2007	10/11/2007	0		UNK	PUB	Unknown	None	None known			1						1	Asthenia; Headache; Nausea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2497AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293134	10/15/2007	WA	82.0	82		F	10/15/2007	Pt experienced itching at bedtime on 10/9/07 at the site of injection. Upon waking in the morning on 10/10/07, arm was sore and swollen; spoke w/ pt on 10/12/07. Symptoms had improved.									Y	10/09/2007	10/09/2007	0		OTH	PVT	Digitek; Lisinopril; Atenolol; Nifedipine; HCTZ; Coumadin; Actonel	N/A	Unknown			1						1	Injection site pruritus; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2453AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0200U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293135	10/15/2007	WA	67.0	67		F	10/15/2007	Patient had a flu shot on 10-12-2007. On the day, she was fine. Next day she had pain on her left arm. On 10-14-07 pain to wrist, said she could barely move her arm.									U	10/12/2007	10/13/2007	1	Patient had a history of notable disc injury	OTH	PVT	N/A	N/A	N/A			1						1	Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~09377V~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293137	10/15/2007	PA	67.0	67		M	10/12/2007	Facial swelling, itching, throat feels thick, swollen lips.				Y					Y	10/04/2007	10/06/2007	2	None	PVT	PVT		Check-up	Allergic to ASA			1						1	Lip swelling; Pharyngeal oedema; Pruritus; Swelling face	FLU3~SANOFI PASTEUR~U2500AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0061U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0293138	10/15/2007	TX	21.0	21		F	10/15/2007	Pt called complaining of shortness of breath and chest pain. Pt advised to proceed to Emergency department.				Y					U	10/15/2007	10/15/2007	0		PVT	UNK	None	None	Post partum 2 wks. gestational hypertension - resolved			1						1	Chest pain; Dyspnoea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80073~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0293139	10/15/2007	WY	68.0	68		F	10/12/2007	(L) upper arm swelling/redness/tenderness - developed ~ 1 day after injection (Seen in office 2d after injection).Tx'd with Loratadine/cool packs. Likely reaction to Pneumovax (tolerated flu shots in past).				Y					Y	10/10/2007	10/11/2007	1	None	PVT	UNK		None				1						1	Erythema; Incorrect drug dosage form administered; Oedema peripheral; Tenderness	DTAP~SANOFI PASTEUR~C2688AA~UNK~IM~RA~DTAP (DAPTACEL)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA029AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~06984~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0293140	10/15/2007	NC	1.6	1	.6	M	10/15/2007	Mom reports (R) leg sl. swollen, non-tender at site of vaccine. Denies lg. hardened area, child is afebrile and acting fine. Gave Mom S/S of sterile abscess and cellulitis. She will observe and call with concerns or questions.									Y	10/03/2007	10/05/2007	2		PVT	PVT	N/A	N/A	N/A			1						1	Injection site swelling	DTAP~SANOFI PASTEUR~U2290AA~4~UN~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2458BA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB163aB~1~UN~LL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~B54007E~4~UN~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0293141	10/15/2007	NC	9.0	9		M	10/15/2007	Localized swelling, redness, pain and itching				Y					Y	10/03/2007	10/04/2007	1		PVT	PUB	N/A	N/A	N/A			1						1	Erythema; Pain; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U2448AA~7+~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0799U~1~UN~RL~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~1106U~2~UN~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0293142	10/15/2007	UT	4.0	4		M	10/15/2007	High fever (>105), headache, achiness				Y					U	10/12/2007	10/13/2007	1		PVT	PVT	None	None	None			1						1	Headache; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2437AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293143	10/15/2007	TX	24.0	24		F	10/10/2007	Pt had myalgia of (R) UE where vaccines have been given. No induration, erythema.										09/28/2007	10/05/2007	7	N/A	PVT	PVT		None	None			1						1	Myalgia	FLU3~SANOFI PASTEUR~U2442AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1063U~1~UN~RA~HPV (GARDASIL)~1|TDAP~SANOFI PASTEUR~C2842AA~1~UN~LA~TDAP (ADACEL)~1	USA		Influenza
0293148	10/15/2007	WI	28.0	28		F	10/10/2007	Pain (severe) at inj site, no numbness and tingling in all extremities. High BP for her 137/94, usual 106/60. Blood sugar 164 down to 118 in 20 minutes (may not be same issue). Labored breathing, cold, sweaty, shaking.				Y					U	10/10/2007	10/10/2007	0		OTH	PVT	Lisinopril 5mg; ASA; Nortryptiline; Lipitor; Novolog	None	Diabetic (Type I)			1						1	Blood glucose fluctuation; Blood pressure increased; Dyspnoea; Hyperhidrosis; Injection site pain; Nasopharyngitis; Paraesthesia; Tremor	FLU3~SANOFI PASTEUR~U2450AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293153	10/15/2007	IN	1.1	1	.1	F	10/12/2007	Pt developed shingles 11 months after vaccine administered. NO known hx of chicken pox.				Y					N	11/28/2006	10/12/2007	318	None	PVT	PVT	None	None	None			1						1	Herpes zoster	FLU3~SANOFI PASTEUR~U2200LA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1095F~1~IM~LL~HEP A (VAQTA)~1|MMR~MERCK & CO. INC.~1027F~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08670A~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1050F~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0293154	10/15/2007	IL	34.0	34		F	10/11/2007	Patient had prescription for the preservative free product. Thimerosal containing product was entered in computer and administered by immunizing RPh. No adverse event recorded. Just noting improper administration.									Y	10/10/2007			None	OTH	PVT	None known	None	None known			1						1	Incorrect drug dosage form administered	FLU3~SANOFI PASTEUR~U2450AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293156	10/15/2007	WI	49.0	49		F	10/14/2007	Red hives on abdomen (7) and breast (5), hips (3) back (2) itching, burning.									Y	10/09/2007	10/11/2007	2		OTH	OTH	PAXIL					1						1	Burning sensation; Erythema; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~AFLLA030AA~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0293158	10/15/2007	ME	59.0	59		F	10/11/2007	Marked swelling of arm distal to injection site with circumferential red, warm skin. Pt was on Biaxin at time of injections.									N	10/09/2007	10/10/2007	1	None	PVT	PUB		Sinusitis	HTN, DM Type 2, Hyperlipidemia, Eczema			1						1	Injection site erythema; Injection site swelling; Skin warm	FLU3~SANOFI PASTEUR~U2466AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~055U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293162	10/15/2007	MA	44.0	44		M	10/10/2007	Pt reported numbness on back portion of tongue about 2 min after vaccine administered. No swelling of lips/tongue or oral mucosa seen. Vital signs WNL and stable. No other signs/symptoms noted. Issue resolved spontaneously after about 1/2 hour. No sequelae reported.									Y	10/09/2007	10/09/2007	0		OTH	PUB	None	None	None			1						1	Hypoaesthesia oral	FLU3~SANOFI PASTEUR~U2501AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293166	10/15/2007	PA	3.0	3		F	10/04/2007	Localized erythema and tenderness w/in 24 hrs of injection.				Y					Y	10/02/2007	10/02/2007	0	None	PVT	PVT		None				1						1	Erythema; Tenderness	FLU3~SANOFI PASTEUR~U2446AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293169	10/15/2007	TX	61.0	61		M		Dizziness, nausea									Y	10/01/2007	10/01/2007	0		UNK	UNK						1						1	Dizziness; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0293342	10/15/2007	NE	61.0	61		F	10/11/2007	Patient called 10/11/2007 complaining of red arm swelling, pain & high grade temperature. Patient did not have thermometer to take temp, but presumed it has high. Advised her to make appointment with doctor.									U	10/10/2007	10/11/2007	1		OTH	OTH		None	None			1						1	Body temperature increased; Erythema; Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~U2493AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296961	10/15/2007	NY	71.0	71		F	11/08/2007	Injection site redness, hardness, aching (in right arm), tiredness. Reaction cleared in week and half.				Y					Y	10/26/2007	10/27/2007	1	Treated for cellulitis; antibiotic, acidophilus and Benadryl	PUB	PUB	Presently on Metformin, Januvia, Niaspon, Lusix, Vyforin, Diovan HCT, Fosomax	None	Diabetes			1						1	Cellulitis; Fatigue; Injection site erythema; Injection site induration; Injection site pain	FLU3~SANOFI PASTEUR~U2467AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1132U~2~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0293249	10/16/2007	MI	1.25	1	.3	F	10/16/2007	Fever started the evening of the shots.  The next day went limp, fell back, jaw clenched, not breathing.  Mom gave rescue breaths and EMS came.  After being cooled by EMR, the rectal temp at ER was 102.				Y					Y	10/10/2007	10/11/2007	1		PVT	PVT	none	none	none			1						1	Hypotonia; Joint stiffness; Pyrexia; Respiratory arrest	DTAP~GLAXOSMITHKLINE BIOLOGICALS~ac14b062aa~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~ut2460aa~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0075u~3~IM~RL~HIB (PEDVAXHIB)~1|PPV~PFIZER\WYETH~b70143d~4~IM~RL~PNEUMO (PNU-IMUNE)~1	USA	Emergency room visit	Influenza
0293250	10/16/2007	MA				M	10/16/2007	Three hours after administration of Fluarix Dr de Delva had profuse sweating, felt cold and clammy and vomited.  This lasted approximately two hours.									Y	10/15/2007	10/15/2007	0	none10	UNK	UNK						1						1	Cold sweat; Feeling cold; Hyperhidrosis; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua296ha~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0293252	10/16/2007	LA	40.0	40		F	10/16/2007	About an hour after receiving flu vaccine large, painful pimple-like hives started appearing all over my face and neck.  I also had a rather large, painful bump in the muscle just above the elbow in my right upper forearm. This bump persisted for approximately 18 hours.  Before taking the vaccine I did ask if having taken my allergy medications, Singular and Hydroxyzine (Atarax), beforehand would be a problem and was told that it would not be.  Some of the hives on my neck disappeared after taking 3 hyrdoxyzine (anti-hive medication) later in the day, but as of 10/16/07 at 9:27AM I still have lots of large, red, soar bumps all over my cheeks and neck. I also have a backache and headache.  The bump in upper forearm had disappeared overnight.  Could all of this be a reaction between the Singulair and the influenza vaccine? Singulair is an asthma medication as well as an allergy medication.  Needless to say, I will never take the flu vaccine again.									N	10/15/2007	10/15/2007	0		PUB	UNK	Singulair and hydroxyzine	None	all corn products (including by not limited to corn starch, corn syrup, corn protein, etc.), milk, codeine and several antibiotics including Bactrin and Seclor, dust mites, and mold.	None~ ()~NULL~~In Patient		1						1	Back pain; Food allergy; Headache; Mass; Urticaria	FLU3~SANOFI PASTEUR~U2437AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293253	10/16/2007	WI	11.0	11		M	10/16/2007	Patient developed wheezing, hives, and flushing within 10 minutes of vaccine administration.  He was treated with epinephrine, Albuterol aerosol, and Prednisone.									Y	10/09/2007	10/09/2007	0		PVT	PVT	Clarinex, Singular, Pulmicort	None	Asthma, allergic rhinits			1						1	Flushing; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U2438AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~12590~2~IM~LA~HEP A (VAQTA)~1|MNQ~SANOFI PASTEUR~U2228AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2688AA~1~IM~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~10960~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0293254	10/16/2007	VA	5.0	5		M	10/16/2007	While receiving the flu shot on the right arm on Thursday October 11, 2007, patient was poked with the needle three to four times before the nurse was able to get the shot in.  The morning of Friday October 12th is when we first noticed patient's right arm starting to swell.  When we removed the band aid at 7:50 pm Friday October 12th, there were three visible little holes, in addition to a scratch that was probably caused when the needle was pulled away, as well as three little boils that were not there prior to the shot that was 15mm down from the three holes.  Saturday October 13th the boils were no longer there but instead a little open wound that is 5mm in length and 1mm in width.  Sunday October 14th the wound began to form a scab around the outer edge.  Saturday October 13th patient's arm continued to swell and it started to become very warm.  Patient complained of a lot of itching. Sunday October 14th patient's arm was swollen a past the elbow.  We called the Nurse the morning of Sunday October 14th.  She told us that based on his symptoms, it is protocol to bring him in especially considering the open wound.  Patient saw Dr. at the office for an 11:00 appointment Sunday October 14th.  Dr. said that she noticed the three places where the needle was and asked if he had other shots.  When we told her that it was only one shot, the flu shot, she said that next time patient needs to come with reinforcements to help hold him down.  She also noticed the place where the little wound was and said to put Neosporin or Bacitracin on it but, she preferred Bacitracin. Dr. said she did not believe that his arm was infected because patient did not change expressions when she touched it twice and he was able to pull and push with both arms and he was able to rotate the arm.  Dr. wrote a prescription for Augmentin to fill only if he started to not be able to move his arm.  Monday October 15th patient stayed home from school.  Patient's arm was still very swollen.  The swelling is now 200 mm from the site of the shot.   The bottom portion of the inner arm looks like a red blotch that is 90mm in length and 70mm wide.   This then increased to include the upper portion of the arm later Monday night.  Patient was experiencing extreme itching and discomfort the night of Monday October 15th.  He was restless and whining about how much it itched.  Also Monday night he started to get areas of large bumps on the lower arm.				Y					N	10/11/2007	10/12/2007	1	None	UNK	UNK	None	No illness at time of vaccination.	G6PD-Deficiency	In 2005 patient was diagnosed with an infection in the arm after receiving the flu shot and was prescribed an antibiotic; the sw		1						1	Crying; Discomfort; Furuncle; Oedema peripheral; Pruritus; Rash; Restlessness; Scab; Scratch; Skin warm; Wound	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0293255	10/16/2007	MN	50.0	50		M	10/16/2007	Swollen lips about 2 hours after shot.  Hives at armpits, groin, waste, and head in about same period.  Took Benedryl about 7 hours after the shot.  This seemed to knock down the hives.  Swollen lips persist into second day. ***No airway problems***.  I do not have a history of allergies or reactions to this shot.									Y	10/15/2007	10/15/2007	0		UNK	PVT	NONE	NONE	NONE			1						1	Lip swelling; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA312BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0293257	10/16/2007	UT	53.0	53		F	10/16/2007	Pain and swelling near left ear beginning 1 day after vaccine administration                  area is somewhat hot         patient took antihistine which seemed to help									Y	10/13/2007	10/14/2007	1	none	UNK	PVT	none	none	none	none~ ()~NULL~~In Patient		1						1	Pain; Skin warm; Swelling	FLU3~SANOFI PASTEUR~42454AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293258	10/16/2007	OR	54.0	54		F	10/16/2007	reddening/soreness of injection site, followed by severe headache, wheezing for about an hour, dizziness, diarrhea. Benadryl, tylenol,imodium.									Y	10/13/2007	10/14/2007	1		UNK	PVT	none	none	none			1						1	Diarrhoea; Dizziness; Headache; Injection site erythema; Injection site pain; Wheezing	FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0293261	10/16/2007	MI	48.0	48		F	10/16/2007	I received my pnenmonia vaccination on Friday, October 11, 2007.  On Saturday, about 24 hours after my vaccination, my heart started racing, nausea, sweaty palms, jittery feeling.  That went away in about 30 minutes.  A few hours later, I took 800mg of Motrin for the stabbing pain at the injection sight.  That helped a little.  By the time evening came, I was just about in tears the pain was so bad.  The pain was traveling up and down my arm.  I had some vicadin from previous tooth ache.  I ended out taking 3 Vicadin on Saturday, 4 on Sunday, 3 on Monday and 1 today.  The pain is no longer stabbing.  That ended on Monday.  But on Sunday and Monday, I have had nausea, stomach cramping, no appatite, hot and cold feeling and an aching feeling all over my body.  Through this whole time the injection sight has been red, swollen and a burning sensation.									N	10/11/2007	10/12/2007	1	I did not go to the docter.  I probably would have if I did not already have some pain medication.  Then my husband got on the internet and found that a very small percentage of people that get this vaccine have a bad reaction.	UNK	MIL	wellbutrin 300 mg once daily	none	depression			1						1	Abdominal pain upper; Anorexia; Feeling jittery; Feeling of body temperature change; Hyperhidrosis; Injection site erythema; Injection site irritation; Injection site pain; Injection site swelling; Nausea; Pain in extremity; Palpitations	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0293272	10/16/2007	CA				M	10/15/2007	Information has been received from a physician concerning a male who, on an unspecified date, was vaccinated with a single dose of Zostavax (Oka/Merck). Vaccinations received on the same day included tetanus toxoid (manufacturer unknown) and influenza virus vaccine (unspecified) (manufacturer unknown). The physician reported that after receiving the vaccinations the patient's hemoglobin levels dropped. The patient was sent to the hospital and admitted. There was no product quality complaint. Hemoglobin levels dropped was considered to be disabling. Additional information has been requested.				Y			Y	Y	U				hemoglobin levels dropped	OTH	OTH			Unknown		WAES0710USA02741	1						1	Haemoglobin decreased	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~UN~UN~TETANUS TOXOID (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~UN~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Hospitalisation,Disabling	Influenza
0293284	10/16/2007	KY	62.0	62		F	10/12/2007	10-8-07 sore, scratchy throat. 10-9-07 3:00 pm fever 103, chills, myalgia, confusion.  11/26/2007 MR received for DOS 10/09-11/2007 with D/C DX Adverse reaction to influenza vaccine.  Pt presented to ER on 10/9/07 with fever and mental status changes/delirium, numbness of feet.  Txd with abx with resolution of fever.					Y	3			N	10/04/2007	10/08/2007	4	Spinal tap - negative results.  Labs and Diagnostics:  WBC 13,000 down to 10,200 on 10/10/07,NEUT 91(H), LYMPH 4 (L).  PT 13.1(H), INR 1.17(L).   NA 135(L), glucose 112(H).  CSF normal.  UA (+) for moderate blood and rare bacteria.  Blood culture (-). Gram stain (-). Group A Strep (-).  Head CT (-). CXR (-). Sinus X-ray (-).  ECG NSR.	PUB	PUB	None	None	None. PMH:  Head concussion with R arm weakness and speech difficulties.  Allergies:  Soma and Baclofen.			1						1	Chills; Confusional state; Lumbar puncture; Myalgia; Pain; Pharyngolaryngeal pain; Pyrexia; Throat irritation	FLU3~SANOFI PASTEUR~U2442AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0293286	10/16/2007	IA	78.0	78		F	10/16/2007	Patient states that she didn't feel well after flu vaccine. Went home, had a light supper, became delirious and required ambulance transfer to hospital. Profound hypoglycemia of 29.  11/07/2007 MR received for DOS 10/15-16/2007 with DX Hypoglycemia. Diabetes Mellitus type 2.  Pt was brought by ambulance to ER for delirium.  Pt c/o not feeling well fater pm meal, but became delirious.  BS in ER on arrival was 29. Pt was given IM Glucagen IV Dextrose which rapidly brough BS to over 200.  Pt remained somnolent, but improved o/n.			Y	Y	Y	1			Y	10/15/2007	10/15/2007	0	Hypoglycemia of 29.  Labs and Diagnostics:  Accucheck 29 then up to 180.  BUN 33. Creatinine 1.5. CBC with low RBC, Hct, Hgb.	PVT	PUB	very long list	None new	DM Type 2, Renal insufficiency, other. PMH: DVT. DM type 2, osteoarthritis, anemia, GERD, HTN, hyperlipidemia, obesity, gout, glaucoma,CAD, diabetic neuropathy, CHF, cataract extraction, CABG, Hysterectomy, PTCA, Vein stripping, cholecystectomy.  Allergies to Coumadin, Lipitor, Zithromax.			1						1	Delirium; Hypoglycaemia; Malaise	FLU3~SANOFI PASTEUR~U2452AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0293287	10/16/2007	KY	76.0	76		M	10/14/2007	Patient developed cellulitis as a result of Fluzone or Pneumovax vaccination. He required hospitalization and antibiotic treatment.  11/06/2007 MR received for DOS 10/12-14/2007 for D/C DX: Cellulitis of the L Forearm, markedly improved. Pt presented to PMD with c/o swelling and redness of the L forearm.  Treated with po abx with no improvement.  Admitted for IV abx. TXd with IV abx with good response.				Y	Y	2			Y	10/09/2007	10/09/2007	0	Labs and Diagnostics:  CXR with no active disease.	PUB	PVT	TORSEMIDE; PREDNISONE; PAMELOR 257mg; OXYCODONE; ENBARIL 10/650	None	Hx stroke, HTN, CAD, CHF, BPH, Hypercholesterolemia, Carotid Artery Stenosis, Renal insuff.  PMH:  CAD, CABGx6, stroke, pacemaker, chronic kidney disease, carotid stenosis, hyperlipidemia, colon polyps, CHF, elevated PSA, renal stone, BPH, LBBB.  NKA.			1						1	Cellulitis	FLU3~SANOFI PASTEUR~U2499AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0962U~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0293290	10/16/2007	GA	14.0	14		M	10/16/2007	Symptoms begun on Sunday, September 30th.  At that time patient had a c/o headache and eye socket pain.  By Wednesday, October 3rd, patient had also started experiencing body aches and neck pain.  On Thursday, patient had neck stiffness, headache, and body aches.  He went to ER at MC and spinal tap was performed.  Results were suspicious for viral meningitis and he was admitted to pediatric unit at MC under the care of Dr.  He was started on IV Rocephin and given Toradol in ER.  He was continued on Recephin in the peds unit and was given Lortab and Motrin for pain.  Patient then started developing urinary retention on Friday but was able to void twice that day with difficulty.   He also begun developing weakness, spasms and tremors in his legs and he fell from loss of balance and his knees locking.  Friday night he was in a great deal of discomfort due to inability to void. In/out cath was done at 5 am and 500 ml of urine was emptied at that time from patient's bladder. Neurologist was consulted on Friday, and he was suspecting transverse myelitis.  Urology was consulted, and he ordered witholding of the Lortab.  Urinary retention continued and Foley cath was placed on Saturday evening.  Symptoms progressed to include numbness/tingling/crawling sensation to legs and then torso.  Pain was experienced with gown touching his skin.  Patient also complained of spine pain.  CT of sinuses was done and unremarkable.  He was also started on Acyclovir IV. MRI was ordered Saturday, done Sunday and showed no spinal cord compression.  Patient was transferred to another facility on Sunday night and at this time his symptoms of wakness, pain, and paresthesias was the worst.  He has been severly uncomfortable with the Foley cath due to spasms athe the insertion site.  He was not able to stand on his own at this time or lift his legs off the bed, he was not able to turn on his own.  He has not been able to sleep resfully any of the nights since first hospitalized. Then, Monday morning, the weakness has improved significantly and he was able to stand, lift his legs off the bed, and walk a few steps with max. assist.  The Foley cath was removed by noon due to his severe discomfort.  He was seen by neurology, Dr. and started on IV Solumedrol.  He continued to improve and was able to void with difficulty later that afternoon.  Patient continued to improve, his bladder functioning better but not quite well.  His bowels have also moved.  Slowly, the numbness /tingling/pain begun to improve as well.  On Monday he was also seen by PT and fitted with a walker, he was able to ambulate in a hallway with minimal problems with balance.  The MRI of brain and entire spine was ordered to be done on Wednesday but not done till Thursday morning.  In the meantime, Patient was also switched to oral Prednisone while the IV Solumedrol was discontinued.  MRI showed changes consistent with ADEM, per neurologist.  Patient was then discharged to home on Thursday afternoon with tapering doses of Prednisone.  His urinary problems have resolved, he was also able to walk unassited.  As of today, he is still weak in his legs, experiences itching on his torso, and has difficulties sleeping.  He is to F/u with the neurologist on November 13,2007. 10/18/07-vac rec received; Menactra U2339AA right arm, Tdap left arm (adacel)c2644aa and Fluzone U2446AA left arm.  10/30/07-records received for DOS 10/7-10/11/07-DC DX: tranverse myelitis. urinary retention resolved. Symptoms on Sunday with eye pain on Wednesday headache, stiff neck on Thursdy, temp 99.2 seen in ER Urinary retention. Saturday while in hospital developed weakness, decreased sensation with intermittent pain in lower extremities. difficulty walking on Sunday. PE: sensory deficit in lower extremity with no muscle weakness.   Nauea and dizziness. Treated with high dose steroids. At time of discharge complaint of tingling sensation in abdomen. Lower extremity weakness improved.  Per 60 day follow up: He does not have any residual symptoms at this time, but F/U MRI in December showed persistent demyelination with no new lesions and minimal improvement from prior study. He has finished 12-week PREDNISONE therapy and suffered many side-effects from this, some of these improved while others still continue. Annual Follow-up Information 08-DEC-2008: F/U scheduled for abnormal eye examinations.			Y	Y	Y	4			U	09/20/2007	09/30/2007	10	See above 10/30/07-records received-LP increased WBC with normal protein, glucose and gram stain. MRI no spinal compression repeat MRI shows diffuse increase in central signal intensity within cerival, thoracic and lumbar spinal cord.Appearance consistent with transverse myelitis. Involvement in both gray and white matter in cervical spine and predominantly gray matter in thoracic and lumbar spine.	UNK	UNK	Ibuprofen	No	osgood schlatter disease, CA MRSA 10/30/07-records received-PMH: viral meningitis 3/06, osgood schlatter. Allergies to Erythromycin.			1						1	Arthropathy; Asthenia; Balance disorder; Bone pain; CSF lymphocyte count increased; Catheter placement; Computerised tomogram; Drug hypersensitivity; Dysuria; Encephalitis; Eye pain; Eye pain; Fall; Formication; Headache; Hypoaesthesia; Insomnia; Lumbar puncture; Meningitis viral; Muscle spasms; Muscular weakness; Musculoskeletal stiffness; Myelitis transverse; Neck pain; Nuclear magnetic resonance imaging normal; Pain; Pain; Pain in extremity; Paraesthesia; Paraesthesia; Pruritus; Pyrexia; Sleep disorder; Tremor; Urinary retention	DTAP~SANOFI PASTEUR~c2644aa~UNK~~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2446aa~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2339AA~UNK~~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Life Threatening,Hospitalisation	Influenza
0293291	10/16/2007	AZ	59.0	59		F	10/16/2007	At noon on 10/12 she began experiencing chills, fevers, severe body aches and pains, generalized malaise, localized reddness, swelling and itching at the site. Also reports she had itching/burning eyes. Presents at Public Health office 10/15 with swelling and reddness in left upper arm and continues to be tired and achey, feels 'clammy and drug out' yet 10/16/07.				Y					Y	10/11/2007	10/12/2007	1	N/A	UNK	PVT	OTC - Vitamin E, Glucosamine/Chondroitin	None	No known allergies, history of Rheumatic Heart Disease as a child			1						1	Chills; Cold sweat; Eye irritation; Eye pruritus; Fatigue; Feeling abnormal; Injection site erythema; Injection site pruritus; Injection site swelling; Malaise; Oedema peripheral; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2453AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0958F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0293294	10/16/2007	IL	51.0	51		F	10/16/2007	One and a half hours after receiving Flu shot, patient broke out in an itchy rash described as small, red, raised spots that covered her whole body.  The rash lasted 5 days.  Patient called her primary physician who prescribed a 7 day Medrol-dose-pack.Patient was in no other distress and did not see the doctor or go to the ER.									Y	10/03/2007	10/03/2007	0	None	PUB	PUB	Arimidix - to suppress estrogen production                        Heparin flush for port in arm	None	Hx of Breast Cancer			1						1	Rash macular; Rash pruritic	FLU3~SANOFI PASTEUR~U2461BA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293297	10/16/2007	MD	47.0	47		F	10/16/2007	At 10:45 the patient was escorted into the health unit by a coworker. Patient was oriented x 3. She was assesed and nursing intervention was provided. Patient stated she felt her throat was closing up while upstairs at her desk so she self administered 25mg of Benedryl sublinqually. Patient stated her throat still fells like it is closing although she took 25 mg of Benedryl. Patient stated she carries sublinqual Benedryl and an epi-pen because she has allergies to certain medication and foods. Upon the patients arrival into the health unit at 10:45 A.M., RN called 911. RN immediately administered 25mg of Benedryl p.o to the patient while (10:50 A.M.) RN administered  0.3cc of epinephrine sub-cu into the patients right arm. Vital signs were as follows: 10:45 A.M. B/P 140/84 P 76  10:55 A.M B/P 144/100 P 88. Paramedics arrived at the health unit at 11:00 A.M. They assessed and evaluated the patient and asked her if she wanted to be transported to the hospital. The patient stated her throat was feeling better. The patient initally declined and then agreed to go to the hospital via ambulance. The patient declined to lie on the stretcher so walked out of the health unit into the ambulance.  The patient left the health unit in stable condition.				Y					Y	10/16/2007	10/16/2007	0		UNK	UNK	Synthroid, Prem Pro	None	Ceftin, Percocet, Shellfish, all Nuts			1						1	Throat tightness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78994~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0293298	10/16/2007	CO	1.0	1	.0	F	10/16/2007	Fever, blister rash that is spreading									N	10/05/2007	10/14/2007	9		PVT	PVT	None	None	31 week pre-mature twin			1						1	Blister; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U2463AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB149AA~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1496F~1~IM~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1217F~1~IM~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0293299	10/16/2007	MO	12.0	12		M	10/10/2007	Patient was given a flu shot in left arm on 10/08/07.  Public health contacted the clinic to take a look at arm.  Softball sized welt on childs arm was present rd and raised.  Patient stated does not itch.  He presented on 10/10/07 2 days after shot given.									Y	10/08/2007	10/10/2007	2		UNK	UNK	Singulair and Claritin	URI	none		MO200733	1						1	Urticaria	FLU3~SANOFI PASTEUR~U2464AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293300	10/16/2007	OH	74.0	74		M	10/16/2007	Patient admitted with ascending muscle weakness and elevated CK. Questionable association for guillian barre. Stated symptoms occured starting the day after flu shot administered, was admitted 6 days after shot with above. Patient treated for rhabdo then transferred to another local hospital. No fever, no chills. Feeling week for 1 week prior to admission. DC Summary received for DOS 10/16-10/31/07-DC DX: acute renal failure secondary to superimposed chronic renal insufficience.  11/13-07-records received for DOS 10/16-10/30/07-DX: Acute renal failure. Rhabdomyolysis. C/O generalized weakness.Rhabdomyolysis status post Tesio catheter. Lower extremity weakness inability to ambulate.					Y	15			U	10/05/2007	10/06/2007	1	ANA -ANTINUCLEAR A POSITIVE;NEGATIVE TEST FOR FLU A ANTIGEN;NEGATIVE TEST FOR FLU B ANTIGEN; CK TOTAL:34741; MONONUCLEOSIS TEST NEGATIVE 11/13/07-records received- CPK of 42000. Labs ANA negative. Sed rate 76, urine protein 150, BUN 62, creatinine 3.3. 12/7/07-	UNK	UNK	(1) Novolin 70/30 subcutaneous 25 units in the morning and 15 units in the evening.  (2) Actos 35 mg per oral once daily.  (3) Furosemide 1-1/2 tablets per oral once daily.  (4) Lisinopril 140 mg per oral once daily.  (5) Diltiazem 240 mg p	no	1) Diabetes mellitus since 1990.  (2) Dyslipidemia.  (3) Peripheral arterial vascular disease.  (4) Hypertension.  (5) Hypothyroidism. 11/13/07-PMH: diabetes mellitus type 2, hypertension, chronic kidney disease, status post bilateral below the knee amputation for peripheral vasooccluse disease. Medications indluced simvastatin and gemibrizole which have been discontinued.			1						1	Blood creatine phosphokinase increased; Influenza serology negative; Mononucleosis heterophile test negative; Muscular weakness; Rhabdomyolysis	FLUX~UNKNOWN MANUFACTURER~?~6~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0293305	10/16/2007	OR	59.0	59		F	10/16/2007	PT SPOUSE REPORTS OUTBREAK OF SHINGLES OCCURRED APPROX 10 DAYS AFTER RECEIVING FLUARIX				Y					Y	10/05/2007	10/14/2007	9		UNK	PVT	NONE KNOWN	NONE REPORTED	NONE KNOWN			1						1	Herpes zoster	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA305BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0293310	10/16/2007	OH	74.0	74		F	10/11/2007	Right deltoid, itching at injection site 1 hour after administration, then swelling, redness and pain increasing next 12 hours.									Y	10/10/2007	10/10/2007	0		PVT	PVT						1						1	Injection site erythema; Injection site pain; Injection site pruritus; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80683~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1084u~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293312	10/16/2007	NE	64.0	64		F		10/9/07 noticed r) arm really hurting, later in day 1500 had redness swelling to r) deltoid and whole upper arm has redness, swelling. Couldn't lift arm without pain. Ibuprofen, hot packs 10/10 has swelling, redness, warm to touch, between elbow and deltoid area. Given Ibuprofen, used warm packs. 10/11/07 reports no pain today. Rt arm has slight pinkish area.									Y	10/08/2007	10/09/2007	1		UNK	UNK	None	None	None			1						1	Erythema; Heat therapy; Oedema peripheral; Pain; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~U2464AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0675F~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293313	10/16/2007	UT	39.0	39		F	10/08/2007	Woozy, hard time walking tongue feels funny, headache, nervous, jittery, drunk hard time speaking, numbness in left pinkie.										10/08/2007	10/08/2007	0		PUB	PVT	Phenobarbital - Dilantin	said had cold, 1x vomiting 2 days ago	Seizures from traumatic brain			1						1	Dizziness; Feeling drunk; Feeling jittery; Gait disturbance; Headache; Hypoaesthesia; Nervousness; Paraesthesia oral; Speech disorder	FLU3~SANOFI PASTEUR~U2443AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293314	10/16/2007	MN	46.0	46		F	10/11/2007	Received Influenza vaccine at approximately 7:30am on 10/10/07. At approximately 11:00am EHS received call that employee c/o itching all over especially hands  and feet. Given Benadryl 25mg which did help. Later that evening took another 50mg of Benadryl. On 10/11/07 report symptoms resolved.									Y	10/10/2007	10/10/2007	0		PUB	OTH	PREMARIN, MINOCYCLINE	None	None			1						1	Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79241~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0293315	10/16/2007	TX	4.0	4		M	10/12/2007	Leg red, swollen, with temperature									Y	10/09/2007	10/11/2007	2	None	PVT	PVT	None	None	None			1						1	Body temperature; Erythema; Swelling	DTAP~SANOFI PASTEUR~C2657AA~5~UN~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2466AA~5~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z1009~5~UN~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~04110~2~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0293318	10/16/2007	WI	87.0	87		F	10/09/2007	10.9.07 3:30 Patient: reports developed blotches on face and itchy sensation from neck to forehead with same puffiness. Relief with baking soda and warm water. Received Flu vaccine on 10-8-07 and developed symptoms about 6 hours later. Reports not as itchy today but blotchy looking plan: notify HCP. 930 10/10/07 patient reports face puffy, dry, itchy, and blotchy: To call HCP.										10/08/2007	10/08/2007	0	10/11/07 patient - saw HCP recommended Prednisone but may not start it spoke with pharmacist; may have had itchy face prior to Flu shot from Spironolactone 5m.	PUB	PVT	Nasal spray; Fluticasone; Synthroid; Methyldope; Spironolactone; Metoprolol; Prevacid; Bepicar		Denied allergies on 10/8/07 consent, but PCN allergy noted previously.			1						1	Dry skin; Pruritus; Rash macular; Swelling face	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78478~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0293319	10/16/2007	MI	54.0	54		F	10/10/2007	Had flu shot Wednesday for 2 days had the a chest pains arm remained warm and red. Gradually started spreading redness. Each day it went a little further around arm.				Y					Y	10/03/2007	10/03/2007	0	cellulitis	OTH	OTH	Lotrel, Lipitor, hydrochlorithroid	None	High blood pressure - cholesterol			1						1	Cellulitis; Chest pain; Erythema; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA294BA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0293320	10/16/2007	VA	61.0	60		F	10/12/2007	Patient received injection at 1210pm at 1230pm she came back with dizziness, increase BP (140/100), pulse 72, tightness of chest. 1240pm BP 140/95, pulse 76 decrease tightness of chest and decrease dizziness 1250pm BP 146/86 pulse 80 still slight tightness of chest and dizziness. Patient went to Urgent Care.				Y						10/12/2007	10/12/2007	0		OTH	OTH						1						1	Blood pressure increased; Chest discomfort; Dizziness	FLU3~SANOFI PASTEUR~U2505AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293321	10/16/2007	NY	9.0	9		F	10/11/2007	Left upper arm between axilla and frontal side with patches of raised, warm erythema medial to injection sit 1) 5cm x 2.5cm 2) 2.5 x 1cm 3) 1.3cm diameter round.				Y					N	10/09/2007	10/10/2007	1		PVT	PVT	Pulmicort, Albuterol	None	Asthma			1						1	Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U2504AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293322	10/16/2007	OH	63.0	63		F	10/11/2007	Received flu vaccine at approximately 10:30am 10/11/07 at 2:00 pm felt slight lump in throat which persisted took Benadryl 25mg PO at 2:30 pm.									U	10/11/2007	10/11/2007	0		PUB	OTH		None	None			1						1	Sensation of foreign body	FLU3~SANOFI PASTEUR~U2478CA~4~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293327	10/16/2007	MD	0.9	0	.9	M	10/13/2007	Intussusception. Onset vomiting, colicky, pain one day prior to Dx and correction via Barium enema reduction. 10/18/07-records received for DOS 10/9-10/10/07-DX: Intussusception. 36 hour history of intermitten fever and abdominal pain, 3 episodes of vomiting and 1 bloody stool. PE: abdomen mildly tender.			Y	Y	Y	1			N	10/01/2007	10/08/2007	7	Abdominal sonogram 10/18/07- Ultrasound positive for intussusception. Barium enema and hydrostatic reduction successful. WBC 12.48, platelets 683, carbon dioxide 21.1 anion gap 16.9. Stool for occult blood positive.	PVT	PVT		None	None			1						1	Abdominal pain; Enema administration; Intussusception; Vomiting	FLU3~SANOFI PASTEUR~u24400aa~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0293328	10/16/2007	NC				F	10/08/2007	After getting flu shot, (L) arm at site of injection became swollen - no redness noted, no itching.									Y	10/05/2007	10/05/2007	0		PVT	PVT						1						1	Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80060~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0293331	10/16/2007	NE	62.0	62		F	10/10/2007	Noted redness, raised, tender, warm at injection site late 10/9/07. Medicated with Aleve. this was first flu vaccine for employee. Currently taking cancer treatment.									U	10/08/2007	10/09/2007	1		PUB	PVT	Benicor; Effexor; Femora	Breast cancer	Hypertension			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2464AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293332	10/16/2007	TX	72.0	72		F	10/10/2007	Shot was given underarm in the adipose tissue. Red area is very large, tender, and inflammed. There is a knot formed.									U	10/06/2007	10/07/2007	1		OTH	OTH		None	None			1						1	Erythema; Inflammation; Nodule; Tenderness; Unevaluable event	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0293333	10/16/2007	NE	37.0	37		F	10/11/2007	10-9-07 area achy and red - encouraged to not rub area, let us know if increased redness, itching, warmth. Pt called approx 1 1/2 hour after and reported decreased redness, still tender to touch. 10-11-07 pt called stated lump size of tangerine and redness on 10-10-07, decreased swelling and redness, cont to be tender.										10/09/2007	10/09/2007	0		OTH	PVT		None	None			1						1	Erythema; Pain; Skin nodule; Tenderness	FLU3~SANOFI PASTEUR~U2442AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293335	10/16/2007	OH	5.0	5		F	10/16/2007	Hives, itching 1 hour after immunizations. Gave Benadryl at home, returned to office - urticaria - Orapred 15mg, Benadryl.				Y					Y	10/12/2007	10/12/2007	0	None	PVT	PVT		None	Russel Silver Syndrome			1						1	Pruritus; Urticaria	DTAP~SANOFI PASTEUR~U2291BA~5~IM~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2942AA~3~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0170~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0426U~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~11070~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0293337	10/16/2007	GA	68.0	68		F	10/06/2007	Severe headache 11 hours after vaccine. Soreness down back and neck and arm. Pt put ice on arm, back and head and too Ibuprofen and Tramadol. Symptoms resolved after 2-3 hours.									Y	10/05/2007	10/06/2007	1	None	UNK	UNK	Tramadol; Zyrtec; Benazepril	None	Penicillin allergy; HTN			1						1	Back pain; Headache; Neck pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2492AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0038U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293338	10/16/2007	MI	38.0	38		F	10/07/2007	Low grade fever, dizzy shortly after injection. In 6-7 hrs facial swelling, muscle aches, shivering, eyelids swelling, abdominal pain, injection site warmth. At 2 AM, patient took 25mg Benadryl and swelling subsided enough to see. later in AM, swelling increased. Administered 100mg Diphenhydramine. Called patient's doctor. Doctor prescribed Medrol dose pack and continue Benadryl q 6 hours for 1 week.									U	10/06/2007	10/06/2007	0		OTH	PVT	Ibuprofen; Fluoxetine; Minocin; Prilosec; Lisinopril; Simvastatin	No	Hypertension, Hypercholesterolaemia, Depression			1						1	Abdominal pain; Chills; Dizziness; Eyelid oedema; Injection site warmth; Myalgia; Pyrexia; Swelling face	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA298AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0293339	10/16/2007	VA	42.0	42		F	10/09/2007	20 minutes after vaccine administration, eyes began to ear and face began to flush - BP 138/80, P 88.									Y	10/09/2007	10/09/2007	0		PUB	PUB	None	None				1						1	Flushing; Lacrimation increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78994~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0293341	10/16/2007	TX	65.0	65		F	10/08/2007	Redness and soreness in arm (right). Treated with OTC Benadryl.									Y	10/06/2007	10/06/2007	0		OTH	PUB	Bactroban ointment; Darvocet	None	Diabetes			1						1	Erythema; Pain in extremity	FLU3~SANOFI PASTEUR~U2493AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~09646~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293343	10/16/2007	IL	41.0	41		F	10/10/2007	Felt warm after 5 min. Felt warm and dizzy after 15 min. Warm, dizzy, blood pressure was 125/75 and save Benadryl 25 min. They stayed another 15-20 min and went home. Patient states felt better when got home.									Y	10/10/2007	10/10/2007	0	BP 125/75	OTH	OTH		None				1						1	Dizziness; Feeling hot	FLU3~SANOFI PASTEUR~U2450AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293344	10/16/2007	NY	47.0	47		F	10/15/2007	Within 1-2 hrs of receiving vaccine, pt. c/0 itching (generalized/all over) and fingers and feet. Given Benadryl 50mg IM at 1005 and Epinephrine 0.3 ml SQ at 1015 - per doctor. Advised to repeat 50mg Benadryl PO per doctor in afternoon.									Y	10/15/2007	10/15/2007	0		OTH	OTH		Reported - none				1						1	Pruritus generalised	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80435~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0293346	10/16/2007	MS	53.0	53		F	10/13/2007	Flu shot in (R) deltoid 10/3/07 4 pm which made (R) arm hurt and swell briefly. Then developed (R) supraclavicular swelling which lasted several days. Shoulder still sore 10/13/07. Saw doctor 10/4 and 10/5/07. Treated MDP and Cefzil.				Y					Y	10/03/2007	10/03/2007	0	CXR negative; WBC 7100; C chest/mediasternum negative; Temp 99	OTH	PVT	Zoloft; Altace; Toprol XL,	None	Allergic to sulfa; HTN			1						1	Chest X-ray normal; Computerised tomogram normal; Musculoskeletal pain; Oedema peripheral; Pain in extremity; Swelling; White blood cell count normal	FLU3~SANOFI PASTEUR~U2450AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293350	10/16/2007	NC	73.0	73		F	10/15/2007	-stiff arm for 11 days. -Felt thick and gooey when injected									Y	06/04/2007	10/04/2007	122		OTH	PVT	Simvastatin, Vit. D, Phenteramine, Metoprolol, Lotrol, Estrace cream	None	None			1						1	Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U2491AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293351	10/16/2007	IN	1.0	1	.0	M	10/16/2007	patent developed urticaria-like rash.									Y	10/08/2007	10/09/2007	1		PVT	PVT		None	None			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2438AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0797U~1~IM~LL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~0487U~1~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B540072~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0293352	10/16/2007	VA	53.0	53		M	10/15/2007	Pt. recd flu vaccine on 10-9-07 and awoke with sores on inside of upper and lower lips on 10-10-07 which had actively bled overnight causing lips to stick together Pt. given lidocaine viscous 27 sol. for ulcers				Y					U	10/09/2007	10/10/2007	1		PVT	OTH		None	None			1						1	Lip ulceration	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0293353	10/16/2007	WA	47.0	47		F	10/16/2007	Bruising-Swelling-Pain Hot To Touch									Y	10/15/2007	10/15/2007	0		PVT	UNK		None				1						1	Contusion; Pain; Skin warm; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0293354	10/16/2007	PA	13.0	13		M	10/16/2007	at site of Varivax, given on 9/17/07 1-2days later developed redness with blackhead with prudent drainage and pain skin abscess drained and cleansed with antibiotics ointment twice daily. Culture sent and placed on Bactrim DS x 10 days. Culture result										09/17/2007	09/19/2007	2	Culture sent of abscess	PVT	PVT		None	Asthma			1						1	Culture; Erythema; Pain; Purulent discharge; Rash vesicular; Subcutaneous abscess	FLU3~SANOFI PASTEUR~U2448AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~109211~UNK~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0293356	10/16/2007	NC	70.0	70		M	10/16/2007	Local skin reaction				Y					Y	10/10/2007	10/11/2007	1		PVT	PVT			All: Clinozol, Elonic			1						1	Local reaction	FLU3~SANOFI PASTEUR~U2506AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0944U~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0293357	10/16/2007	PA	55.0	55		F	10/16/2007	Cellulitis reported by patient - doctor prescribed Clindamycin 300mg capsules q 6 h x 10.				Y					U	10/13/2007	10/16/2007	3		PUB	PVT		None known				1						1	Cellulitis	FLU3~SANOFI PASTEUR~U2507AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0989U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0293359	10/16/2007	CA	33.0	33		F	10/12/2007	Sore throat/SOB, wheezing, red blurry eyes, low grade fever. Tingling/sore at site of inj. after inj x 20 min.				Y					Y	10/11/2007	10/11/2007	0	None	PVT	UNK		None	No			1						1	Dyspnoea; Ocular hyperaemia; Paraesthesia; Pharyngolaryngeal pain; Pyrexia; Vision blurred; Wheezing	FLU3~SANOFI PASTEUR~U2498aA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293360	10/16/2007	CA	64.0	64		F	10/16/2007	10-13-07 1130 received flu vaccine right deltoid. 10-14-07 23 hours later awakened with pain and swelling from injection and into armpit. Patient applied heat to armpit and deltoid, swelling decreased only to increase when heat was removed. Unable to use right arm from 10-14-07 to 10-16-07. Missing work 10-15-07. 10-16-07 Unable to raise arm to shoulder height. Unable to lift weight with right arm. Deltoid and armpit still swollen 10-16-07 but decreased.									U	10/13/2007	10/14/2007	1	Recommended being seen by primary care physician.	PUB	PUB	Oral diabetes medication; Blood pressure; Levoxyl; Hormone replacement.	None	Diabetes Type II; High blood pressure			1						1	Injected limb mobility decreased; Injection site pain; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79489~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0292178	10/17/2007	PA	73.0	73		F	10/14/2007	Pneumonia shot in right arm.  Upper arm from shoulder to elbow was swollen twice the normal size with redness and sore to touch.  Fever of 101 degrees and chills, headache with nasal drainage, itchy eyes.									Y	10/03/2007	10/03/2007	0	None	OTH	UNK		None	None			1						2	Headache; Nasal congestion; Ocular hyperaemia; Oedema peripheral; Pain; Chills; Eye pruritus; Headache; Injection site erythema; Injection site pain; Injection site swelling; Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~42492AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0803U~2~IM~RA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~~UNK~UN~RA~PNEUMO (NO BRAND NAME)~2	USA		Influenza
0292942	10/17/2007	OH		0	.0	F	10/17/2007	This case was reported by a physician and a pharmacist and described the occurrence of death nos in a 3-day-old female subject who was vaccinated with Fluarix (GlaxoSmithKline). Concurrently the subject received ampicillin and gentamicin. On 5 October 2007 the subject inadvertently received a dose of Fluarix at 0.5 ml in an unknown thigh. This was considered to be a medication error as Fluarix is not indicated for pediatric use. The infant was supposed to received Engerix B, but was administered Fluarix. At an unspecified time after vaccination with Fluarix, the subject experienced apnea and was hospitalized. The subject later died due to an unspecified cause. It was unknown whether an autopsy was performed. The physician reported via a pharmacist that apnea was probably not related to treatment with Fluarix.	Y				Y	0			N	10/05/2007	10/05/2007	0	UNK	MIL	PVT	Ampicillin trihydrate, Gentamicin sulphate	Unknown	She received gentamicin and ampicillin as prophylaxis because the mother presented to the hospital sick with stomach pains. The infant subject was delivered at 35 weeks gestation via an emergency c-section.		A0687750A	1						2	Chest X-ray normal; Cyanosis neonatal; Death; Dehydration; Infantile apnoeic attack; Jaundice neonatal; Lethargy; Sepsis; Wrong drug administered; Apnoea; Autopsy; Death; Medication error; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA302BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3028A~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Results in Death	Influenza
0293425	10/17/2007	GA	72.0	72		F	10/10/2007	Patient came in on 10/5/07 (3 days later) with red, raised area on left arm. She stated she felt nauseous and that the raised red place was growing bigger over the last 3 days. She was given Claritin 10 mg tablets once daily for 7 days and asked to report to doctor immediately. Contacted doctor on 10/9/07 - pt determined to have skin infection and was treated with Cephalexin for 7 days. Per pt arm is back to normal.				Y					Y	10/02/2007	10/05/2007	3	Per nurse in doctor's office, patient lab work revealed skin infection.	OTH	OTH	Not known	None when questioned patient	Allergy to kidney dye per patient			1						1	Erythema; Nausea; Oedema peripheral; Skin infection	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79897~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0964U~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0293426	10/17/2007	CA	77.0	77		F	10/05/2007	Fever, slight chills, red skin 5-6 inches in diameter, 2 below vaccination site of RD (Pneumovax).									Y	10/01/2007	10/02/2007	1		OTH	UNK	Acyclovir; Allopurinol; Astelin; Ciprofloxacin; Clonazepam; Cozaar; Doxazosin; Estradiol; Felodipine; Fexofenadine; Fluzone; Hydrochlorothiazide; Hydrocodone	None				1						1	Chills; Erythema; Pyrexia	FLU3~SANOFI PASTEUR~U2498AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0961U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293431	10/17/2007	CO	76.0	76		F	10/03/2007	24 hours post vaccination pt experienced erythema and heat that spread to elbow and up through chest and armpit. Painful to move extremity. She is treating with acetaminophen and ice. (This is regarding her Pneumovax vaccination)										10/01/2007	10/02/2007	1	N/A	OTH	PVT	Metoprolol; Omeprazole; Simvastatin; Vit D; Levothyroxine; Diazepam	No	N/A			1						1	Erythema; Injected limb mobility decreased; Skin warm	FLU3~SANOFI PASTEUR~U2488AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293433	10/17/2007	NM	54.0	54		F	10/05/2007	Vaccine was given on 10/3, late at night patient experience SOB, swollen face, HA. See MD the next day and was given Toradol and advise to take Benadryl.				Y					U	10/03/2007				OTH	OTH						1						1	Dyspnoea; Headache; Swelling face	FLU3~SANOFI PASTEUR~U2498AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293435	10/17/2007	OH	47.0	47		F	10/03/2007	10/3 at 10 AM. Pat. called 10/3 and said she was on her way to the doctor. Felt ok until 10/2 at 3 PM. Noticed red raised bump. Currently has a fever of 102. Sx completely resolved by 10/5/07.				Y						10/01/2007	10/02/2007	1	Tx'ed with Naproxen (Dx: ultra histamine rxn) Xyzal	OTH	PVT		None	None			1						1	Erythema; Hypersensitivity; Pyrexia	FLU3~SANOFI PASTEUR~U2500AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0962U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0293436	10/17/2007	CA	46.0	46		F	10/05/2007	Redness, swelling, near injection site. Tx: cold compress and Ibuprofen.									Y	10/04/2007	10/04/2007	0	None	OTH	PVT	Unknown		Unknown			1						1	Cold compress therapy; Erythema; Swelling	FLU3~SANOFI PASTEUR~U2438AA~UNK~SC~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~O0834~UNK~SC~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293439	10/17/2007	UT	72.0	72		F		Swelling like a large muscle (like men) Red fever to elbow - hurting (stinging).									U	10/08/2007	10/08/2007	0		OTH	OTH						1						1	Erythema; Muscle swelling; Pain; Skin warm	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0293440	10/17/2007	FL	75.0	75		F	10/08/2007	Pt describes reaction as very hot and itchy and site about 8 cm erythema with induration upon exam.				Y					Y	10/02/2007	10/03/2007	1	N/A	PVT	PVT	Avapro ISO; Remeron; Wellbutrin; Boniva	None	HTN; GERD; Increased Lipids			1						1	Injection site erythema; Injection site induration; Pruritus; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA0422AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|VARZOS~MERCK & CO. INC.~088U~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0293441	10/17/2007	CA	56.0	56		F	10/03/2007	Red stripe on back of arm, red stripe inch below injection site, R Deltoid only affected arm (Pneumovax). No treatment needed.									Y	10/01/2007	10/03/2007	2		OTH	PUB	Aciphex; Femhrt; Fluzone; Ipratropium; Pneumovax	None				1						1	Erythema; Injection site streaking; Skin striae	FLU3~SANOFI PASTEUR~U2463AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293442	10/17/2007	CA	67.0	67		F	10/03/2007	Rash developed two inches below injection site, about 5-6 inches in diameter. Pt given prescription for Keflex and Benadryl.									Y	10/01/2007	10/02/2007	1		OTH	PUB	No other record of meds	None				1						1	Rash	FLU3~SANOFI PASTEUR~U2463AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293443	10/17/2007	CA	66.0	66		M	10/03/2007	Stripe inch away from injection site of PNEUMOVAX  (RD). Developed fever. Pt took OTC TYLENOL, relieved pain and fever.									Y	10/01/2007	10/02/2007	1		OTH	PUB	ACTOS; amoxicillin; bumetanide; CELEBREX; ciprofloxacin; FLUZONE; gembifrozil; LIPITOR; PNEUMOVAX 23; potassium; PROTONIX; triamterene; TRICOR; uroxatral; VIAGRA; VYTORIN; WELCHOL; ZETIA					1						1	Injection site streaking; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2463AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293445	10/17/2007	MI				M	10/08/2007	Wheezing. Was given Depo Medrol IM and Benadryl IM and sent to ER. Pt improved by time seen in ER.				Y					Y	10/02/2007	10/02/2007	0		PVT	PVT	Lipitor; Verapamil; Lopressor; Imdur; Vasotec; Panabid; Kdur; Lasix; Theophylline		Penicillin, Codeine, Heart Dx, COPD, Asthma			1						1	Wheezing	FLU3~SANOFI PASTEUR~U2465AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293446	10/17/2007	MN	10.0	10		F	10/10/2007	(L) arm local reaction initially itchy then painful. 10 cm erythema, induration, tenderness area VVX site.				Y					Y	10/08/2007	10/09/2007	1	None	PVT	UNK			Sulfa Allergy			1						1	Injection site erythema; Injection site induration; Injection site pain; Local reaction; Pain; Pruritus	FLU3~SANOFI PASTEUR~U2461BA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1060U~1~IM~RA~HPV (GARDASIL)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~52B016BA~1~IM~LA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1001U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0293448	10/17/2007	IL	60.0	60		M		Flushing and mild dizziness.									Y	10/09/2007	10/09/2007	0	None	OTH	PUB	Metoprolol; Lisinopril; HCTZ; Terazosin; Omeprazole; Allopurinol	None	Hypertension; Gout; PTSD; Esoph reflux; Depression			1						1	Dizziness; Flushing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80435~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0293452	10/17/2007	TX	32.0	32		F	10/08/2007	started with a mild headache on 10/7/07 around noon and progressively getting worse toward the end of the day. At around 6:30 PM, headache is worse (splitting/throbbing) and had 2 episodes of vomiting. Have to get home early and not finish work that day. Took ZOFRAN ODT at 7PM vomiting / Took Advil migraine at 7:30 p.m - Headache better at around 12 p.m.									Y	10/06/2007	10/07/2007	1	None	PVT	OTH	Prilosec; Tylenol Sinus; Allergy - PRN	None	seasonal allergies, latex allergies; GERD			1						1	Headache; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA280CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0293453	10/17/2007	WI	57.0	57		F	10/09/2007	Patient states had sudden onset of severe pain, in bilateral legs - right shin and left foot and ankle pain. Lasted 15 minutes, then gradually went away. Fine this AM.									Y	10/08/2007	10/08/2007	0	None	PVT	PVT	HCTZ; ZETIA; PROTONIX; ACTIGAL; FISH OIL; RHINOCORT; GARLIQUE; LISINOPROL	None	Biliary Cirrhosis; hypercholesterolemia; Seasonal allergies			1						1	Arthralgia; Pain in extremity	FLU3~SANOFI PASTEUR~U2486AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293455	10/17/2007	IN	38.0	38		M	10/17/2007	Hives to body, vomiting.				Y					Y	10/15/2007	10/15/2007	0		OTH	PVT		None	None			1						1	Urticaria; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78990~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0293456	10/17/2007	MA	87.0	87		F	10/04/2007	Local reaction with redness (patchy) pain at site of vaccine and below (right upper arm).									N	10/02/2007	10/02/2007	0	None	PVT	UNK		None	Sulfa/ Codeine			1						1	Injection site erythema; Injection site pain; Local reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79241~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0601F~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293459	10/17/2007	GA	70.0	70		F	10/02/2007	Patient received vaccine 11am on 9-29-07. On 9-30-07 around 630pm injection site became red, swollen, itchy and burning - symptoms subsided on their own then returned evening of 10-1-07. Patient called pharmacy. She was told to try Benadryl and to report reaction to her doctor. She may possibly be allergic to the to the preservative.									U	09/29/2007	09/30/2007	1		UNK	UNK		None	None			1						1	Injection site erythema; Injection site irritation; Injection site pruritus; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79240~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0293462	10/17/2007	NH	36.0	36		M	10/05/2007	Fever, myalgia, area of erythema, warmth, LUE 5 x 5 inches.				Y						10/03/2007	10/04/2007	1		PUB	UNK		H/O				1						1	Erythema; Myalgia; Pyrexia; Skin warm	FLU3~SANOFI PASTEUR~U2467AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~09620~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0293463	10/17/2007	IL	72.0	72		F	10/08/2007	Patient felt like throat was closing in. She went to Nurse Practitioner and got an injection of Benadryl and was fine after that also went to urgent care and but was fine after couple hours.				Y					Y	10/05/2007	10/05/2007	0		OTH	PVT	LESCOL XL; PLAVIX; STARLIX, METOPROLOL XL; ZETIA; DIOVAN; OMEPRAZOL; KLORCON	None				1						1	Throat tightness	FLU3~SANOFI PASTEUR~U2493AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~0885U~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0293467	10/17/2007	ID	79.0	79		M	10/17/2007	Pt was found with a decreased level of consciousness in which his blood sugar was 33, on one touch.				Y					Y	10/17/2007	10/17/2007	0	One touch blood sugar of 33	PVT	PVT	Coumadin; Trazadone; Lasix; KaL; Zocor; Coree; Lisinopril	none	CHF; HTN; MDD; Congenital Coronary artery anomaly; OTH; sequalae MI nec			1						1	Blood glucose abnormal; Blood glucose decreased; Depressed level of consciousness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA040AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0293468	10/17/2007	AZ	13.0	13		F	10/17/2007	Immediately following administration of shots got up from exam table and had syncopal episode with collapse for seconds, developed pallor + emesis after. No airway compromise, vital signs normal. Follow-up Information 06-NOV-2007: 14 year old female presents with c/o pain for 3 weeks bilateral knee pain, achiness all the time worse with activity, Advil about one time per day for the last 1 week. Points to lateral aspect of both knees where tendon inserts. Denies: direct trauma, fall. Denies any redness, swelling or other joint pain. Had gardisil vaccine 10/16/07 and family concerned that the joint pain may be related. Also play club soccer with practices 2-3 times per week and games on the weekend. Discussed at length with patient and parents. History and exam c/w tendonitis likely from overuse. Rec advil 400 mg 3 times per day for one week, rest when possible, ice or heat prn. Does not have a break from soccer until the holidays. Also rec doing Jump exercises for adolescent girls they will talk to trainer at school and look on Internet. Could be related to vaccine with small percentage of girls in studies having arthralgias but would expect it to be getting better. Gave Parents phone number for Merck to call and further discuss vaccine with them. Doubt autoimmune with no family history and no other signs or symptoms but if no improvement over the next 1-2 months especially after 1-2 week rest from soccer would consider doing blood work. arthralgia									Y	10/16/2007	10/16/2007	0	VS 98.8, BP 128/64 HR 75; orthostatic BP's laying 100/62 sitting 100/60 standing 102/60	PVT	UNK	Advil day before visit	mild sore throat no fever	craniosynostosis treat with surgery @ 11 mos of age			1						1	Arthralgia; Immediate post-injection reaction; Pallor; Syncope; Vomiting; Arthralgia; Syncope	FLU3~SANOFI PASTEUR~U2443A~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0802U~1~IM~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~O2419AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|FLU3~SANOFI PASTEUR~U2419AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|HPV4~MERCK & CO. INC.~0802U~1~IM~UN~HPV (GARDASIL)~2|MNQ~SANOFI PASTEUR~U2443AA~1~IM~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~2	USA		Influenza
0293469	10/17/2007	CA	0.5	0	.5	F	10/12/2007	hives all over body within 1 hour of vaccines. NO wheezing or shortness of breath. Benadryl given.									Y	10/05/2007	10/05/2007	0	RAST testing for egg allergy pending.	PVT	PUB	None	None	eczema			1						1	Radioallergosorbent test; Urticaria	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B126BB~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U12459MA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B54016K~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0969U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0293470	10/17/2007	CA	1.3	1	.3	M	10/12/2007	Seizure occurred on same day as immunizations. Lasted 2 min, temp 102.7. No prior history of seizures.				Y					Y	10/05/2007	10/05/2007	0	None	PVT	PUB	Fluoride	None	Eczema			1						1	Body temperature increased; Convulsion	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B061BB~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2459MA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~854016K~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0293472	10/17/2007	VA	78.0	78		M	10/17/2007	Pt received Flu shot on 10/15/07. Had seizure 10/16/07. Seen in ER for new onset seizure. Started on Dilantin.				Y					Y	10/15/2007	10/16/2007	1	Seen in ER.	PUB	PUB	Colace syrup; Bisacodyl suppository; Prilosec; Zantac; Tylenol	None	No known allergies			1						1	Convulsion	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA030AA~1~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0293474	10/17/2007	KS	71.0			F	10/17/2007	Was possibly given diphth-tetanus booster instead of a flu shot 10-08-07.									Y				None	PVT	PVT		Diabetes type II; Otitis externa	Aller - PCN, Sulfa, Monopril; Vasotec			1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA042AB~2~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1|TD~MASS. PUB HLTH BIOL LAB~Td196~2~IM~UN~TD ADSORBED (TDVAX)~1	USA		Influenza
0293475	10/17/2007	KS	65.0	65		M	10/17/2007	Accidently gave dipth/tetanus instead of flu vaccine on 10-8-07. (possibly)									Y	10/08/2001			None	PVT	PVT		Diabetic; AFib; Fibromy	Procardia, Relafen, Grisetulvin			1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLAC42AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|TD~MASS. PUB HLTH BIOL LAB~Td194~UNK~UN~LA~TD ADSORBED (TDVAX)~1	USA		Influenza
0293478	10/17/2007	PA	33.0	33		M	10/17/2007	Pt reported being very disoriented as a side note pt had take 1mg Ativan 2 hours before vaccine.									Y	10/10/2007	10/10/2007	0		PVT	PVT		Rheumatoid arthritis	Rheumatoid arthritis			1						1	Disorientation	FLUX~UNKNOWN MANUFACTURER~AFLLA027AA~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0555U~1~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293479	10/17/2007	ME	57.0	57		F	10/17/2007	Pt came in having rash and swelling in left upper arm after Flu shot on 10/15/07. The rash extended up to her neck across her left shoulder and down under her arm. It is hot and painful. Used cold packs. Take antihistamine PRN, cold packs, Zithromax.									U	10/15/2007	10/16/2007	1		PVT	PVT		None	Obesity, HTN, Hyperlipidemia, PTSD, Anxiety, Asthma			1						1	Injection site pain; Injection site rash; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80957~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0293480	10/17/2007	MD	60.0	60		F	10/15/2007	Allergic reaction red, swollen. Patient states site was itchy.									U	10/09/2007	10/10/2007	1		UNK	UNK		Unknown	Unknown			1						1	Erythema; Hypersensitivity; Oedema peripheral; Pruritus; Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80961~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0293481	10/17/2007	DC	57.0			F	10/15/2007	None stated.									U	10/10/2007	10/11/2007	1		OTH	PVT	Unknown	Unknown	Unknown			1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80961~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0293483	10/17/2007	KY	9.0	9		M	10/17/2007	Day after vaccine pt developed some swelling to arm at injection site. 2 Days after administration Redness and Swelling to arm 10 cm x 17 cm. c/o painful to touch				Y					Y	10/15/2007	10/16/2007	1		PVT	PVT	Zyrtec, Nasonex	No	Asthma			1						1	Erythema; Injection site swelling; Pain	FLU3~SANOFI PASTEUR~U24618A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0797U~1~IM~LA~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~1071V~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0293484	10/17/2007	FL	65.0	65		F	10/16/2007	Redness, swelling noted to left upper arm. Pt recovered.									Y	10/15/2007				PUB	UNK		N/A				1						1	Injection site erythema; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79721~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0859U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293485	10/17/2007	TX	35.0	35		M	10/08/2007	Vaccine given 10/5 at 0700; temp increased 102 and projectile vomiting (multiple) - all on 10/6/07. Hypertensive.  02/18/2008 MR received for DOS 10/6-7/2007 with D/C DX: Self-limiting Acute Gastroenteritis.  Pt had RBBB on EKG. Pt presented to ER with c/o sudden onset severe abdominal cramping and projectile vomiting (8-9 episodes). Temp 101.9 in ER.  PE (+) for dry mucous membranes, otherwise WNL. TXd with IVF, Zofran, Compazine and Ativan with sx resolving by 10/7/07					Y	1			Y	10/05/2007	10/06/2007	1	Labs and Diagnostics:  EKG showed RBBB. CBC with WBCs 12.4. Chemistry WNL.  Blood cultures (-).	PUB	OTH	Tenoretic, Meridia, Lipitor	None	NKDA; HTN; High cholesterol. PMH:  HTN, Hyperlipidemia, overweight, Urinary calculi, NKDA.			1						1	Body temperature increased; Condition aggravated; Hypertension; Vomiting projectile	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA280CA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0293486	10/17/2007	WV	77.0	77		F	10/08/2007	None stated.				Y						10/05/2007	10/05/2007	0		OTH	OTH						1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2467AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293487	10/17/2007	PA	83.0	83		M	10/08/2007	10-3-07 resident received Pneumonia and Flu vaccine in the same injection. On 10-05-07 erythema noted at the site.									Y	10/03/2007	10/05/2007	2	N/A	OTH	PUB	Colace, Spironolactone; Demadex, Claritin, Coumadin	Muscular Dystrophy; Hypokalemia	CHF, Aphasia, Obesity			1						1	Incorrect dose administered; Injection site erythema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79721~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1004F~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293488	10/17/2007	PA	94.0	94		F	10/08/2007	On 10-3-07 resident received pneumonia and flu vaccine through the same injection. No adverse reaction.										10/03/2007			N/A	OTH	PUB	N/A	N/A	N/A			1						1	Incorrect dose administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79721~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1004F~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293489	10/17/2007	PA	61.0	61		F	10/08/2007	10-3-07 resident received pneumonia and flu vaccine. There was erythema, induration and elevated temp. 1:20 AM resident sent to ER. Pneumonia and flu vaccine combined in same injection.				Y					Y	10/03/2007	10/04/2007	1	N/A	OTH	PUB	Prilosec; Spironolactone; Omeprazole; Lisinopril	Hx ETOH	Mood disorder; Anxiety; ETOH; CBS/OSB			1						1	Body temperature increased; Erythema; Incorrect dose administered; Induration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79721~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1004F~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0293490	10/17/2007	PA	85.0	85		M	10/08/2007	On 10-3-07 received pneumonia and flu vaccine thru the same injection. Patient observed with slight edema and slight temperature elevation.									Y	10/03/2007	10/04/2007	1		OTH	PUB	Discal; Toprol; ASA; Plavix; Fosamax; Risperadol		Dementia, HTN, Osteoporosis debility			1						1	Body temperature increased; Incorrect dose administered; Oedema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79721~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1004F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293491	10/17/2007	PA	67.0	67		M	10/08/2007	10-3-07 resident received pneumonia and flu vaccine thru the same injection. Reaction was erythema, induration and elevated temperature.									Y	10/03/2007	10/04/2007	1	N/A	OTH	PUB	Effexor, Xanax, NHP, Clonidine, Isosorbide, Ability, Risperadol	IDDM; Dementia	IDDM; Dementia; Schizo Psychosis; Anxiety			1						1	Body temperature increased; Erythema; Induration; Wrong technique in drug usage process	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79721~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1004F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293492	10/17/2007	PA	87.0	87		F	10/08/2007	On 10-3-07 resident received Pneumonia and flu vaccine thru the same injection. No adverse reaction										10/03/2007				OTH	PUB						1						1	Wrong technique in drug usage process	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79721~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1004F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293493	10/17/2007	CO	55.0	55		F		Flu vaccine given 3:00 PM - 8:00 PM went to ER. Dry cough, red eyes - lungs clear, patient may have allergic rx - gave Tamiflu (Patient didn't fill) and hydrocodone cough syrup. Called patient's physician and explained event. Called patient; said she was ok but had wheezing, cough, flu symptoms, racing heart.									Y	10/08/2007	10/08/2007	0	None	OTH	OTH	NitroQuick; Lotamax; Doxycycline; Hydrocodone	N/A				1						1	Cough; Influenza; Ocular hyperaemia; Palpitations; Wheezing	FLU3~SANOFI PASTEUR~U2488AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293495	10/17/2007	OH	5.0	5		M	10/15/2007	On 10-12-07 Fri. red around mouth about 5:30 pm, spread within hour hives on arms, legs, trunk after Friday evening. Started improving. Better Sat morning. Gave antihistamine, generic Zyrtec. Couple hives chin Sat. By Sunday much improved. Clear today, Monday 10-15-07.									Y	10/10/2007	10/12/2007	2	Mother also reports that on Thursday 10-11-07, patient played with a balloon he got from a restaurant, rubbing it on his skin for static effect.	PUB	PVT	None	Mild cold symptoms	None known, Hx hernia repair 1-06, umbilical and inguinal			1						1	Erythema; Urticaria	FLU3~SANOFI PASTEUR~U2436AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293496	10/17/2007	OH	68.0	68		F	10/12/2007	10-1-07 - Pneumonia shot right arm. By PM 10-1-07 - upper arm hard, swollen, hot, painful itching. 10-2-07 called my doctor. Was put on medication advised to cell doctor- I notified pharmacy									Y	10/01/2007	10/01/2007	0	Allergic Reaction	OTH	OTH	Crestor, Nexium	No	No			1						1	Hypersensitivity; Induration; Oedema peripheral; Pain in extremity; Pruritus; Skin warm	FLUX~UNKNOWN MANUFACTURER~~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~UN~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0293499	10/17/2007	CA	78.0	78		F		Hives for about three days but not in full days only mostly night. But I did sleep. But on Sept 25th 4 days before Flu shot I received for the first time an im injection called Epogen 40000/ml									Y	09/29/2007				PVT	UNK						1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0293500	10/17/2007	VA	13.0	13		F	10/17/2007	Received three vaccines.  Left Arm - HPV #2 and Right Arm - Fluzone and Hepatitis A.  Immediately after receiving vaccines, patient c/o feeling faint, nauseated and weakness in the legs.  Patient remained coherrent and blood pressures remained stable.  After 15 minutes, patient was released c/o of very mild weakness but reports that it was improving as she stood longer in one place.									Y	10/17/2007	10/17/2007	0		PVT	PVT		No reported illnesses.	None listed.			1						1	Dizziness; Immediate post-injection reaction; Muscular weakness; Nausea	FLU3~SANOFI PASTEUR~U2505AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0797U~2~IM~RA~HEP A (VAQTA)~1|HPV4~MERCK & CO. INC.~1061U~2~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0293501	10/17/2007	NJ	60.0	60		M	10/17/2007	Runny nose and eyes 6 hrs after shot. Extreme diarrhea about 10-12 hrs after the flu shot. Violent shaking about 12 hrs after the shot lasting for about 3 hrs. Couldn't catch my breathe, shaking so hard couldn't put on my glasses or hold a pen. No fever.									U	10/16/2007	10/16/2007	0		PVT	PVT	Plavix, Toprol, Diovan, Lipitor, aspirin, niacin	None	Penicillin, Vasetec, heart attack 12/24/06			1						1	Diarrhoea; Dyspnoea; Lacrimation increased; Rhinorrhoea; Tremor	FLU3~SANOFI PASTEUR~u2492aa~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293506	10/17/2007	LA	44.0	44		U	10/17/2007	Approximately 20 minutes after my shot my throat became extremely painful and hoarseness,I had to take my rescue inhaler, I became very dizzy and weak and I ached all over. I was also running 99.4 temp. I was feeling fine before my flu shot and after I had to go home and go to bed. This lasted 2 days.Also my site swelled and became extremely red and sore.									U	10/15/2007	10/15/2007	0		PUB	UNK	advair 550/50, zoloft 150mg q d,cenestin,nasonex,albuterol rescue inhaler,chlordiazepoxide/clidinium one cap q day	none	asthma, allergic to grass,dust mites and beef	none~ ()~NULL~~In Patient		1						1	Asthenia; Body temperature increased; Dizziness; Dysphonia; Injection site erythema; Injection site pain; Injection site swelling; Pain; Pharyngolaryngeal pain; Body temperature decreased; Pain; Wheezing	FLUX~UNKNOWN MANUFACTURER~clinic will not~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U2486AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0293507	10/17/2007	UT	82.0	82		F	10/16/2007	On the right arm where pneumococcal vaccine was administered, patient had discolored area of deltoid, bicep and tricep 16 hours after vaccination with some heat in that area.  Called patient 24 hours later and symptoms had subsided and heat was gone.  PT was seen by PA at Hospital.									Y	10/13/2007	10/14/2007	1		UNK	UNK	CELEBREX 100 MG	NONE	NONE			1						1	Injection site discolouration; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81113~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~09614~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293510	10/17/2007	GA	4.0	4		M	10/17/2007	Approx 3 inch long, 2 inch wide red/hot/swollen local reaction.									Y	10/15/2007	10/15/2007	0		PVT	PVT		N/A	N/A			1						1	Erythema; Local reaction; Skin warm; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0293512	10/17/2007	MA	62.0	62		F	10/17/2007	Patient said 4 hours after injection she was driving home and got dizzy so needed to pull off the highway and wait to pass.  She said it only lasted a few minutes.  Patient explained that she also has a history of headaches, dizziness, and sinus issues.  She said she was not too sure of what caused the sudden dizzines but wanted to tell me the reaction she experienced.									Y	10/15/2007	10/15/2007	0		PUB	UNK	Coumadin	Headache, dizziness, sinus				1						1	Dizziness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA280Da~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0293514	10/17/2007	TX	70.0	70		M	10/17/2007	PAIN AT SITE OF INJECTION FOR PNEUMOVAX. PATIENT WENT TO PCP WHO DIAGNOSED INFECTION AT SITE OF INJECTION FOR PNEUMOVAX AND PRESCRIBED ANTIBIOTICS									Y	10/13/2007	10/13/2007	0		UNK	UNK		NONE				1						1	Injection site infection; Injection site pain	FLU3~SANOFI PASTEUR~U2499AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0803U~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293516	10/17/2007	GA	57.0	57		F	10/17/2007	Fast heart beat-awaken from sleep; symptoms lasted X 2 hours; symptoms resolved spontaneously									Y	10/15/2007	10/16/2007	1	none	PVT	PUB	1. Asa 81 mg i po daily 2.  Combipatch 0.05-.025mg   3. Flecainide 75 mg i po daily  4. Testosterone 1% gel	none	Atrial Fibrillation-stable     Migraine Headaches			1						1	Heart rate increased	FLU3~SANOFI PASTEUR~U2440AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293518	10/17/2007	TX	78.0	78		F	10/17/2007	fever of 103 for 3 days. reddness on injection arm continuing today.  Weekness also continuing today.									N	10/11/2007	10/11/2007	0		UNK	PUB		none				1						1	Asthenia; Injection site erythema; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua307ba~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0991U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293519	10/17/2007	MA	4.0	4		M	10/17/2007	erythema and edema at site, generalized itching. Caregivers feel he had same reaction to vaccine last year									Y	10/09/2007	10/11/2007	2		PVT	PVT		allergic dermatitis				1						1	Injection site erythema; Injection site oedema; Pruritus generalised; Similar reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~u2476HA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293521	10/17/2007	NY	47.0	47		F	10/17/2007	Influenza vaccination administered at 09:45 am on 10/16/07.  Patient presented to health unit at 11:00am with syptoms of generalized body warmth, redness and tight feeling in throat.  VS 124/80-72-20  Pt. was alert & oriented x 3. No respiratory distress noted.  Generalized rednesss & hives noted to face, neck, torso & upper extremities.  Pt. given 0.3cc SQ of epinephrine and 911 called.  VS recheck 138/80-84-20. Pt. given benadryl en route and evaluated at local ED. Pt given prednisone at the ED and sent home with a prednisone pack.  Pt returned to work on 10-17-07 with no c/o.				Y					Y	10/16/2007	10/16/2007	0	See #7	UNK	UNK	Restasis, Valtrex, Zyrtec, Niaspan,clonodine	None /    Approximately 4 weeks previous diagnosed with ear infection & placed on unknown antibiotic...resolved	Allergy to Penicillian, History of breast cancer			1						1	Erythema; Skin warm; Throat tightness; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78994~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0293524	10/17/2007	MN	0.58	0	.6	M	10/17/2007	Patient received Hepatitis A vaccine Havrik 720 for 15 month old at 6 months due to medical assistant error identification of two well child checks at similar times and giving the Hepatitis A .Patient also received DTap and Influenza .25 On October 15th Patient came in for a return visit with symptoms that mother and physician feel were unrelated to Hepatitis A vaccine administration . On Saturday, infant was irritable the entire time he was awake, did not sleep well , had a barking cough and fever. During the Monday visit, infant was afebrile at 97.6. Doctor noted that infant had excessive crying that settled during visit.				Y					Y	10/12/2007	10/13/2007	1		PVT	PVT		No				1						1	Cough; Crying; Inappropriate schedule of drug administration; Irritability; Poor quality sleep; Pyrexia	DTAP~GLAXOSMITHKLINE BIOLOGICALS~ac14b056ba~1~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2456AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB207aa~1~IM~UN~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0293527	10/17/2007	TX	52.0	52		F	10/17/2007	intense itching of arms head eyes and trunk, diseminated hives									Y	10/17/2007	10/17/2007	0		UNK	PVT		multiple sclerosis	multiple sclerosis			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~u2466aa~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293529	10/17/2007	GA	83.0	83		F	10/17/2007	The pneumo vaccine was given at 11:30am on 10-13-07 in the right arm.  At 4:30pm on the same day, the pharmacy received a call from the patient complaining of severe soreness in the right arm and stating that the arm was useless and that she was unable to move it.  There was no swelling, difficulty breathing or fever reported.									U	10/13/2007	10/13/2007	0		UNK	PVT						1						1	Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~u2467AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0038u~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293531	10/17/2007	WA	61.0	61		F	10/17/2007	Large amount of swelling to below injection site of her left arm									Y	10/17/2007	10/17/2007	0	None	PVT	UNK	Glipiside Er 10 mg 1 BID,Glucophage 850 mg TID,Hydrochlorothiazide 25 mg daily, Lantus Insulin 100 Units at HS, Metoprolol 25 mg daily, Prilosec 20 mg daily	None	NKA			1						1	Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80063~5~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0964U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293535	10/18/2007	NC	32.0	32		F	10/18/2007	Tightness in chest, coughing, mild difficulty breathing, lump in throat approximately 6.5 hours after immunization.  Called employee health nurse line, nurse said to call 911 and take a benadryl, but I did not comply as I did not feel like this was life threatening, opting instead to take two (2) 25mg Benadryl.  Symptoms resolved in approximately 1 hour following Benadryl.									Y	10/17/2007	10/17/2007	0		UNK	PVT	Claritin for seasonal allergies, Yaz for birth control	none	seasonal allergies			1						1	Chest discomfort; Cough; Dyspnoea; Sensation of foreign body	FLU3~SANOFI PASTEUR~U2500AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293536	10/18/2007	OH	41.0	41		M	10/18/2007	Called in reporting generalized tingling over entire body which started about 3 hours after injection.  No redness or swelling.  Referred to ER.				Y					N	10/17/2007	10/17/2007	0		PUB	PVT	none	none	none			1						1	Paraesthesia	FLU3~SANOFI PASTEUR~U2498AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293540	10/18/2007	MI	8.0	8		F	10/18/2007	Right arm began to turn red and swollen 10/16/2007pm. Advised to go to ER 10/16/2007. Went to ER, given Bactrim. Called 10/17/2007 3:40pm came to clinic, advised again to go the ER for IV antibiotics. Arm more red and swollen with vc sides at sight of injection of right arm.				Y					U	10/15/2007	10/16/2007	1	none	UNK	UNK	none	none	none			1						1	Injection site erythema; Injection site swelling; Oedema peripheral	FLU3~SANOFI PASTEUR~U2501AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1184U~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0293541	10/18/2007	FL	75.0	75		F	10/18/2007	Client stated had fever diarrhea, elevated BP and went to her doctor and was told had hyponatremia. Her and her doctor concurred it must have been caused by the flu shot. she is being followed by her private doctor.				Y					Y	10/09/2007	10/10/2007	1		PUB	PVT						1						1	Blood pressure increased; Diarrhoea; Hyponatraemia; Pyrexia	FLU3~SANOFI PASTEUR~U2492AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293542	10/18/2007	KY	1.0	0	1	M	10/18/2007	RASH ON LEGS AND SPREAD TO TORSO WHILE IN OFFICE. NO FEVER, NO COUGH, POSITIVE ITCHING.									U	11/09/2006	10/16/2007	341	NONE	UNK	UNK	ZANTAC, ZYRTEC	GERD,MODERATE MALNUTRITION.				1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~UT2176AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0654F~1~IM~LL~HEP A (VAQTA)~1|HIBV~SANOFI PASTEUR~F009AB~1~IM~RL~HIB (ACTHIB)~1|MMRV~MERCK & CO. INC.~1119F~1~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08646H~2~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0293567	10/18/2007	OH	15.0	15		F	10/17/2007	Information has been received from a physician concerning a 15 year old female with penicillin allergy, with no illness at the time of vaccination whose reported weight was 154 pounds and whose reported height was 62.5 inches, who on 20-SEP-2007 was vaccinated into the left arm with the second dose of Gardasil, (Lot # 658556/1060U), and concomitantly was vaccinated into the right arm with influenza virus vaccine (unspecified), (manufacturer Sanofi), (Lot # U2444AA). It was reported that the patient had received previously multiple doses. In the afternoon (P.M.) of 23-SEP-2007 it was reported that the patient developed severe right-sided abdominal pain requiring hospitalization. It was reported that all laboratory test and abdominal scans were normal. It was reported that all pain resolved in 4-5 days. Subsequently, the patient recovered from severe right-sided abdominal pain reportedly on 29-SEP-2007. Additional information has been requested.				Y	Y	0			Y	09/20/2007	09/23/2007	3	Unknown	PVT	PUB		Penicillin allergy			WAES0710USA03084	1						1	Abdomen scan normal; Abdominal pain; Laboratory test normal	FLU3~SANOFI PASTEUR~U2444AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1060U~2~UN~LA~HPV (GARDASIL)~1	USA	Hospitalisation	Influenza
0293574	10/18/2007	FL	66.0	66		M	10/15/2007	2 days after vaccine his rt elbow became very sore/painful. Eventually lost use of fingers and his rt hand. Saw MD at two facilities (MRI's - many tests). Had physical therapy.  11/6/07 Reviewed hospital medical records which reveal patient experienced RUE pain, weakness & wasting of right hand.  Had been seen by routine chiropractor for manipulation of upper back which created pain 1 week prior to start of symptoms.  Seen by pain management 11/06, hand surgeon 2/26/07,  neurologist 3/19/07.  Received thoracic epidural injection which provided pain relief.  Exam by hand surgeon on 2/26/97 revealed obvious atrophy of right hand & distal forearm.  Referred to neurosurgery & PT/OT.  Returned to hand surgeon 3/19/07 s/p EMG/NCS w/diagnosis of Parsonage Turner syndrome.  Neurosurgeon did not feel C5-C6 herniation/stenosis was causing current problem.  Was to continue observation x 1 year & if no improvement, consider multiple tendon transfers surgery. FINAL DX: brachial plexus plexitis c/w Parsonage Turner syndrome. 1/15/2010 No change-worse								Y	N	10/16/2006	10/19/2006	3	MRI's/other EEG, EMG LABS: 12/2006 had c-spine MRI, brain MRI & right brachial plexus MRI w/moderate bilateral neural foraminal stenosis at C5-6 level, worse on right with bulging disk.  EMG/NCS 3/19/07 & 10/29/07 were abnormal & c/w Parsonage Turner variant.	PUB	UNK			Hx of stroke 4-5 yrs ago 2001-02			1						1	Arthralgia; Electroencephalogram; Hypokinesia; Muscular weakness	FLU3~SANOFI PASTEUR~U2239AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0293575	10/18/2007	MI	1.83	1	.8	F	10/18/2007	Child received 1 dose of Tdap instead of Dtap.Mother states child has had no symptoms other than being crabby the night she was vaccinated									Y	10/16/2007			N/A	PUB	PUB	none	none	none			1						1	Inappropriate schedule of drug administration; Irritability	FLU3~SANOFI PASTEUR~U2446AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB200AA~2~IM~LL~HEP A (HAVRIX)~1|HIBV~MERCK & CO. INC.~1270F~4~IM~RL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~1031F~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08690DD~4~IM~LL~PNEUMO (PREVNAR)~1|TDAP~SANOFI PASTEUR~C2572AA~4~IM~RL~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1025U~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0293577	10/18/2007	TX	61.0			F	10/18/2007	Symptoms began late evening on day vaccine was administered and included chills, aches, shortness of breath, nausea, tachycardia and cough.  Symptoms lasted until the next morning then subsided. No treatment was required.									Y	10/17/2007	10/17/2007	0		PUB	PVT		COPD, Hepatitis C, Cirrhosis	COPD, Hepatitis C, Cirrhosis			1						1	Chills; Cough; Dyspnoea; Nausea; Pain; Tachycardia	FLU3~SANOFI PASTEUR~U2445AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293580	10/18/2007	LA		76		F	10/18/2007	patient with difficulty breathing, rash/urticaria, diffuse redness, and swelling of the throat. This occurred within 30 minutes of receiving an influenza vaccine. Treatment included epinephrine 0.3 mg IM, diphenydramine 50 mg IV, methylprednisolone 125 mg IVP, famotidine 20 mg IVP.  Patient observed for 3 hours and discharged home.				Y					Y	10/09/2007	10/09/2007	0		PVT	PVT		NOne	Medical Conditions: bilateral knee replacements, hernia repair, hysterectomy, cancer, hypothyroid, arthritis, congestive heart failure, hypertension.  Patient reports allergy to Pneumovax with reaction of edema.	edema~Pneumo (Pneumovax)~NULL~~In Patient		1						1	Dyspnoea; Erythema; Pharyngeal oedema; Rash; Urticaria	FLU3~SANOFI PASTEUR~U2442AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293581	10/18/2007	TX	29.0	29		F	10/18/2007	Received fluzone vaccine on 10/11/07 to left arm.  On 10/12/07 mid morning, felt nausea and started to vomit.  Also had trembling to right arm.  Seen in ER on 10/12/07 and admitted for 3 days.  10/23/07Hospital medical records reviewed which reveal patient experienced wheezing, fever, chills, flu-like symptoms, cough, HA, SOB & chest pain day following her first ever flu vaccine.  Admitted 10/12-10/14/2007.  Improved & d/c to home on oral antibiotics, oral steroids, benadryl & prilosec. FINAL DX: SOB/chest pain, improved; negative cardiac enzymes; allergic reaction to flu shot, stable; wheezing, improved; diabetes mellitus, stable; HTN; stable.				Y	Y	3			Y	10/11/2007	10/12/2007	1	LABS: EKG WNL. Serial cardiac enzymes neg. CBC WNL.  Chemistry WNL except for elevated glucose.  CXR WNL.	UNK	UNK	NA	No	diabetes PMH:diabetes, HTN, hyperlipidemial, obesity.			1						1	Nausea; Tremor; Vomiting	FLU3~SANOFI PASTEUR~U2450AA~3~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0293583	10/18/2007	GA	84.0	84		F	10/18/2007	Patient ran fever.  She had a sore spot at injection site.  She had large red spot on same arm & red spots on chest & breast.									Y	10/15/2007	10/15/2007	0		UNK	PVT						1						1	Injection site pain; Pyrexia; Rash macular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflla065aa~7+~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0985f~7+~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293585	10/18/2007	MD	51.0	51		F	10/18/2007	Pt received Anthrax Vaccine #2 in her left deltoid region, and Fluarix in her right deltoid. For the following two days she had flu-like symptoms. The anthrax injection site became reddened, tender swollen and firm. She began taking 800mg Motrin 3 times a day. Pt returned on 16 Oct and was assessed. The induration measures 50x50mm. The reddened area measures 37x32mm. She denies breathing problems. No swelling of the mouth region.				Y					Y	10/11/2007	10/11/2007	0	none	MIL	MIL	NONE	NONE	SULFA			1						1	Influenza like illness; Injection site erythema; Injection site induration; Injection site pain; Injection site swelling	ANTH~EMERGENT BIOSOLUTIONS~FAV112~2~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA282EA~6~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0293587	10/18/2007	MA	42.0	42		F	10/18/2007	Breathing become agitated,coughing, shortness of breath.									Y	10/16/2007	10/16/2007	0	none	PUB	PVT	N/A	N/A	N/A			1						1	Agitation; Cough; Dyspnoea	FLU3~SANOFI PASTEUR~U2501AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293590	10/18/2007	AL	27.0	27		F	10/18/2007	had severe arm pain radiating to neck, no swelling,no itching,no rash,no trouble breathing				Y					Y	10/18/2007	10/18/2007	0	went to her doctor	PUB	PVT		none				1						1	Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79718~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0293593	10/18/2007	TX	57.0	53		F	10/18/2007	Patient says one 10/05 (day after immunization) she went to the ER experiencing pain in lower back and was diagnosed with shingles.  She says the night of the immunization she felt a stye in the eye and a slight fever.  She was treated in the er for shingles				Y					N	10/04/2007	10/05/2007	1		UNK	PVT	None	patient feeling fine at time of vaccination	none			1						1	Back pain; Herpes zoster; Hordeolum; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua307ba~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0991u~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0293594	10/18/2007	OK	70.0	70		M	10/18/2007	Client presented to drive through flu exercise for influenza vaccination.  Gave history of having had flu shots in past without incident.  No contraindications to vaccinations identified. Client was vaccinated and returned home.  At some time after returning home client went to Hospital emergency room where he coded and expired.   10/23/07 Reviewed hospital medical records which reveal patient experienced weakness & decreased respirations upon arriving home s/p flu shot.  Collapsed in seat of pickup truck.  EMS intubated, started CPR & transported to hospital.  CXR revealed right pneumothorax & chest tube placed. 1/8/08 Reviewed autopsy report which states COD as COPD with atherosclerotic cardiovascular disease & CHF as contributing factors.	Y	10/18/2007		Y					N	10/18/2007	10/18/2007	0	CXR right pneumothorax.	UNK	UNK	unknown		PMH: COPD on home O2.  ASCVD, s/p CABG.  Recent hx of hemoptysis & URI			1						1	Death	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78995~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0293595	10/18/2007	KS	57.0	57		F	10/18/2007	vaccine administered approximately 10:30am on Oct 15,2007.  By evening, fatigue, aches, sore throat and hoarse cough set in.  Approximately 2am, awoke with chest pain, tingling - took aspirin.  As of 8am, Oct 18, still fatigued, hoarse cough with some phlegm, aches persist.									Y	10/15/2007	10/15/2007	0	Re:  9 above:  flu symptoms persist to present  - day 4.	UNK	PVT	none	none	high cholesterol; wellbutrin allergy			1						1	Chest pain; Cough; Fatigue; Increased upper airway secretion; Influenza; Pain; Paraesthesia; Pharyngolaryngeal pain; Productive cough	FLU3~SANOFI PASTEUR~U2510AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293598	10/18/2007	KS	45.0	45		F	10/18/2007	Client received initial influenza vaccine on 10-17-2007 at approximately 12 noon.  Client first noticed symptoms at 530am on 10-18-2007 of itching under the L arm, with progression of hives occurring over the trunk, arms and neck.  She was advised to seek immediate treatment/consultation with her physician.  She did call that office, and they will be contacting her. Client did state during the symptom notification phone conversation that she has 2 sisters that cannot tolerate vaccines derived from egg product or that contain mycins.				Y					U	10/17/2007	10/18/2007	1		UNK	UNK	HCTZ, Dilitiazem, Prozac	NONE				1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2489AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293599	10/18/2007	CA	48.0	48		F	10/18/2007	Influenza vaccine given 10/11/07 at 8am to left upper arm.  At 8pm on 10/11/07 developed a bruise and rash to left upper arm.  The rash spread to neck and chest area. Rash was itching and lasted until Sunday 10/14/07 morning									Y	10/11/2007	10/11/2007	0		PUB	PVT						1						1	Contusion; Pruritus; Rash	FLU3~SANOFI PASTEUR~U2454AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293601	10/18/2007	DC	0.59	0	.6	F	10/18/2007	Frankly bloody stool and severe irritation 2 days after vaccine given.				Y					Y	10/12/2007	10/14/2007	2	Stool Culture negative, Occult blood Positive, O&P negative,  KUB  normal,  Abd US normal	UNK	UNK		No	None			1						1	Culture stool negative; Haematochezia; Occult blood positive; Parasite stool test negative; Skin irritation; Ultrasound abdomen normal; Urinary system X-ray	DTAP~SANOFI PASTEUR~C2765AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2474FA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0490U~3~IM~LL~HEP B (RECOMBIVAX HB)~1|HIBV~SANOFI PASTEUR~UF164AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B08702A~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1127U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0293602	10/18/2007	TX	75.0	75		M	10/18/2007	2 hours after receipt of flu shot patient became dizzy and shot of breath.									Y	10/17/2007	10/17/2007	0	none	PUB	PVT		none	none			1						1	Dizziness; Dyspnoea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0293603	10/18/2007	WA	35.0	35		F	10/18/2007	Two and a half after administration of flu vaccine experienced urticaria all over her body. On 10/3/07 Received 50 MG of IM Benadryl and was instructed to continue with PO Benadryl over night.  Next morning she still had the hives and continued to itch.  She came in to the Walk-In-Clinic to be treated with Claritin 10 MG daily and Benadryl 50 MG up to 4 hrs PRN if needed.  She tolerated the treatment well and has had no further problems				Y					Y	10/03/2007	10/03/2007	0		UNK	UNK	Orthonovum 777(Generic) Started on 9/5/2006.  L-Thyroxine 0.75 MG every day.  Omeprazole QD.	No illness	Gastroesophageal reflux disease and probable irritable bowel syndrome, history of tension migraines, Chronic intermitent lumbar pain, Symptoms of hypothyroism, replacement started on 01/06.  Goiter suppresive therapy, Patiene is a research patinet on the HPV vaccine study 108933/010-Principle investigator is MD.  Started on 3/12/07 and anticipate conclusion of study on 03/09.  Possible medications:  HVP-1618 L1/ASO4 vaccine versus Mercks Gardasil recombinant vaccine.			1						1	Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA211A~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0293609	10/18/2007	IL	54.0	54		F	10/14/2007	No streaks but a 1 purple line 1 above elbow front part of arm. Patient didn't treat. Color change to light yellow and is all slowly disappearing. Started night of shot. Pt had pain 1st night - better by 2nd day.									Y	10/12/2007	10/12/2007	0		PUB	PVT		None	None			1						1	Skin discolouration	FLU3~SANOFI PASTEUR~U2514aA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0555U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293610	10/18/2007	WA	34.0	34		M	10/18/2007	Dx: Hives. Developed face - neck - torso rash starting evening of day of injection - gradually worse until seek medical care: treated with Benadryl, Loratadine and Kenalog injection.				Y						10/16/2007	10/18/2007	2		OTH	OTH	None	None	None			1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79239~2~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0293611	10/18/2007	CO	32.0	32		F	10/18/2007	Fever 101 beginning day after immunizations. Large area of redness surrounding injection site, worsening. General malaise and myalgias. Area about 11 cm x 8 cm erythema/induration (L) deltoid. Tx: Omnicef 600mg po q day x 10 days. Follow up in 3 days.									U	10/16/2007	10/17/2007	1	None	PVT	PVT	Amitriptyline	None	Depression			1						1	Erythema; Induration; Injection site erythema; Malaise; Myalgia; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79719~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0993U~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293612	10/18/2007	MI	58.0	58		F	10/18/2007	Passed out after flu shot.									Y	10/18/2007	10/18/2007	0		OTH	PVT	None	None	NKA			1						1	Loss of consciousness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA294EA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0293613	10/18/2007	OR	26.0	26		F	10/18/2007	Immunized at gyn office Mon 10/15/07 about 12:00, by 6 pm developed fever, chills, nausea, vomiting. Tuesday developed urticaria.				Y					Y	10/15/2007	10/16/2007	1	N/A	PVT	OTH	Orthotricyclen		NKDA			1						1	Chills; Nausea; Pyrexia; Urticaria; Vomiting	FLU3~SANOFI PASTEUR~U7489AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293617	10/18/2007	IL	73.0	73		F	10/18/2007	RED, SWOLLEN, AND WARM TO TOUCH ON UNDERSIDE OF ARM (NOT AT INJECTION SITE). PATIENT HAS TAKEN BENADRYL AND REACTION IS SLOWING DOWN (ON M.D. INSTRUCTIONS)									U	10/16/2007	10/16/2007	0		OTH	PUB	(UNKNOWN)	NONE	NONE (UNKNOWN)			1						1	Erythema; Oedema peripheral; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA305BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0988F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293620	10/18/2007	KY	37.0	37		F	10/18/2007	Patient experienced more than localized discomfort. Complained of extreme pain in right arm following pneumovax vaccination. Also complained of swelling not around vaccine site but anterior aspect of upper arm with blotchy redness and itching.									U	10/16/2007	10/16/2007	0		OTH	PVT						1						1	Erythema; Oedema peripheral; Pain in extremity; Pruritus; Rash macular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA311AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1344U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293621	10/18/2007	MN	25.0	25		M	10/17/2007	Td given at primary MD's office (primary MD did not give record). Patient had no knowledge of receiving Td at primary MDs office. PH nurse reviewed past record from PH - last Td was given in 1991. Tdap was given 10/16/07. Primary MDs office notified. Unable to contact patient - left for travel overseas.										10/16/2007	10/16/2007	0	N/A	PVT	PVT	Unknown	None	None			1						1	Inappropriate schedule of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA027AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB183AA~UNK~IM~LA~HEP A (HAVRIX)~1|TD~SANOFI PASTEUR~U1949BA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1|TDAP~SANOFI PASTEUR~C2826AA~UNK~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0293622	10/18/2007	MN	22.0	22		F	10/17/2007	Td given at primary MD's office, no record given., patient had no knowledge of Td given at primary MD - Public Health reviewed patient recollection of last Td given patient was unable to recall - so Tdap was given. Primary MD office notified - unable to contact patient for follow up -									U	10/16/2007				PUB	PVT	Unknown	none	none			1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFILA027AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVAB183AA~1~IM~RA~HEP A (HAVRIX)~1|TD~SANOFI PASTEUR~U1949BA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1|TDAP~SANOFI PASTEUR~C2826AA~UNK~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0293625	10/18/2007	CA	79.0			F		right upper arm swelling/redness									Y					UNK	UNK	Novovax, tegretol, Valium, ASA, Zoloft, Nortriptyline	None	Pen			1						1	Erythema; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~62551AA~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~09644~UNK~IM~RA~PNEUMO (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~249623AA~UNK~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0293627	10/18/2007	OH	41.0	41		F	10/16/2007	Itchy, Swollen, Red - entire Body; BENADRYL 25mg x3, CLARITIN Per PMD.									Y	10/11/2007	10/13/2007	2		OTH	OTH	FIH Oil, Actenlol, calcium, Indernol	No	Yellow-Jacket bite one month Prior - Had Reaction			1						1	Generalised erythema; Pruritus; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80060~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0293628	10/18/2007	MA	1.0	1	.0	F	10/15/2007	Simple Febrile Seizure x 1minute Temp 105 deg				Y					Y	10/10/2007	10/13/2007	3		PVT	PVT		None	None			1						1	Body temperature increased; Febrile convulsion	FLU3~SANOFI PASTEUR~U2458BA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVBB0AA~1~IM~LL~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1120U~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0293629	10/18/2007	MA	1.3	1	.3	F	10/15/2007	none; Patient received a 0.5 ml Fluzone instead of the recommended 0.25 Fluzone. no adverse event									Y	10/15/2007	10/15/2007	0	none	PVT	PUB	Fluoride	none	none	7/20 and 7/23 Rash~Measles + Mumps + Rubella + Varicella (ProQuad)~1~1.00~In Patient		1						1	Incorrect dose administered; No adverse reaction	DTAP~SANOFI PASTEUR~U2289ba~4~UN~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2458FC~3~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF144AA~4~UN~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B08679K~4~UN~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0293630	10/18/2007	LA	32.0	32		F	10/15/2007	Given on 10-10-07. S/S started 10-11-07 at 0800 S/S - welts, SOB, itching. To ER 10-14-07 RX Prednisone and Benadryl. 10-15-07 Back to Normal				Y					Y	10/10/2007	10/11/2007	1		PVT	PVT	Accupril, Glucophage - PCOS	minor cold: and fever.	HTN. PCOS			1						1	Dyspnoea; Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA031AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0293632	10/18/2007	NM	81.0	81		F	10/12/2007	Red, warm, edematous R arm - inj given in deltoid - Sx below elbow joint, tender to touch.  Cold packs - elevate, RTC 10/1507 if Sx persist.									Y	10/10/2007	10/12/2007	2	None	PVT	PVT	Zocor. Lortuss, Coumadin, glucophage, pancrease, Lanoxin, Lasix	None	At Fib, CHF, HTN, MVR			1						1	Erythema; Oedema peripheral; Skin warm; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79488~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~09934~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293633	10/18/2007	GA	79.0	79		F	10/15/2007	10/11/07 Red, raised area, 6x4 urticaria at injection site, reported by PCP - Dr.				Y					Y	10/10/2007				PUB	PUB	UNK	No	Codeine			1						1	Injection site erythema; Injection site swelling; Injection site urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~NOV 80433~6~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~MSD0601F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0293724	10/19/2007	SC	39.0	39		F	10/19/2007	Swelled up the size of an egg, red, and very itchy. The itching drove me nuts because it hurt to touch it so I didn't want to scratch it. The swelling, redness and pain have gone away but it still itches.									Y	10/11/2007	10/11/2007	0		PVT	PVT	Protonix, Wellbutrin, Effexor, Zyrtec	None	Penicillin, Bactrim, Everything outside			1						1	Erythema; Pain; Pruritus; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0293725	10/19/2007	MI	56.0	56		F	10/19/2007	Vaccine given approx. 7:40am on 10-18-07.  Approx. 5:30pm, nausea, vomiting and hives.  Took Benadryl w/some relief.  10-19-07 8:00am, pt called office - feeling better, just weak.  Called again at 9:00am stating hives are returning.  Seen in office at 10:00am, dx: serum sickness.  Pt now remembers having similar reaction last year to flu vaccine (never reported it).				Y					Y	10/18/2007	10/18/2007	0		UNK	PVT	Premarin, Zocor, Lisinopril qd and Benadryl & Zyrtec PRN.		Allergies:  Zithromax, Sulfa, Cats & Nickel.	serum sickness~Influenza (Seasonal) (no brand name)~UN~44.00~In Patient		1						1	Asthenia; Nausea; Similar reaction on previous exposure to drug; Urticaria; Vomiting	FLU3~SANOFI PASTEUR~U2446AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293727	10/19/2007	SC	71.0	71		F	10/19/2007	Patient experienced rash all over her body.  The day after the shot, she said she had cold chills and aching.  The patient was instructed by the pharmacist on duty to take benadryl and to contact her primary care physician.									U	10/15/2007	10/16/2007	1		UNK	PUB	Clobetasol prop cream .05%, alprazolam 0.5mg					1						1	Chills; Pain; Rash generalised	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA303BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0293733	10/19/2007	GA	1.0	1	.0	F	10/19/2007	Fever to 104.0 and irritability starting about 12 hours after multiple immunizations (Vaqta, Fluzone, Comvax, Prevnar).  No other symptoms.  Exam unremarkable, urinanalysis normal.  All symptoms resolved in <24 hours.									Y	10/17/2007	10/17/2007	0		PVT	PVT	Prilosec	None	Gastroesophageal Reflux			1						1	Irritability; Pyrexia; Urine analysis normal	FLU3~SANOFI PASTEUR~U2458AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0002U~2~IM~RL~HIB + HEP B (COMVAX)~1|HEPA~MERCK & CO. INC.~0797U~1~IM~LL~HEP A (VAQTA)~1|PNC~PFIZER\WYETH~B08700K~4~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0293752	10/19/2007	FL	64.0	64		M	10/17/2007	Pt is a 65 yo male, hyperlipidemia, cluster headaches, GERD, BPH who developed fever 102, chills 16 hours after vaccines given. Pt drink a lot of water and then developed decreased mental status. On exam cellulitis of (L) arm - triceps arm was noted.  10/23/07 Received pneumo lot #.  VAERS database updated w/same.  10/23/07 Received hospital medical records which reveal patient experienced swelling of left biceps with fever, chills, lethargy & altered mental status.  Admitted 10/13-10/15/2007.  Nephrology consulted for low Na & ID consult done.  Tx w/IV antibiotics.  Progressed well & d/c to home on oral antibiotics. FINAL DX: Cellulitis of left biceps, hyponatremia.			Y		Y	2			Y	10/11/2007	10/12/2007	1	Nat 117; WBC 16,000 + Left shift LABS: WBC 16.2, neutros 82%.  UA WNL. Na 120.  US of left UE WNL. CXR WNL.	PVT	PVT	PROTONIX; LIPITOR; CLONIPINE; FLOMAX	None	Hyperlipidemia; Cluster Headaches; GERD: BPH PMH: allergies to sulfa & tetracycline.  Allergic rhinitis, frequent URIs, pneumonia, migraines, hypertrophic cardiomyopathy.			1						1	Blood sodium decreased; Cellulitis; Chills; Mental status changes; Pyrexia; White blood cell count increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80687~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0959F~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0293755	10/19/2007	IL	61.0	61		F	10/19/2007	12HRS AFTER VACCINATION THE FOLLOWING SYMPTOMS OCCURRED: NAUSEA/VOMITTING/CHILLS/ RIGHT SIDED HEADACHE/ LEFT SIDED BODY PAIN/ STIFF NECK, PROFOUND FATIGUE/ DIARRHEA. VOMITTING AND CHILLS LASTED FOR 4HRS.  THE REMAINING SYMPTOMS LASTED FOR 36 HRS.  FATIGUE, NAUSEA, AND DIARRHEA CONTINUE TO REMAIN 60 HRS AFTER RECEIVING THE VACCINE.									U	10/16/2007	10/17/2007	1		UNK	PVT	SYNTHROID, DICLOFENAC, GLUCOSAMINE/CHONDRODIN,LIPITOR, EVISTA	NONE	ALLERGIC REACTION TO IVP DYE AND DEMEROL;  HAD RECENT ALLERGIC REACTION TO CT SCAN (1 MONTH AGO) - EVEN THOUGH GIVEN PROPHALETIC MEDS OF PREDINSONE AND BENADRYL.			1						1	Chills; Diarrhoea; Fatigue; Headache; Musculoskeletal stiffness; Nausea; Pain; Vomiting	FLUX~UNKNOWN MANUFACTURER~???~UNK~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0293756	10/19/2007	NC	26.0	26		F	10/19/2007	On 10-17-07 noted edema, redness, warm to touch, and painful in left upper ext.  On 10-18-07 pt. assessed by Dr. (temp. 97.6, noted 6.5 X 3.0 cm induration and redness).  Applied ice and Naprosyn ordered.  Spoke with pt. on 10-19-07; s/s: edema, redness, pain, and warm to touch has decreased. No further s/s noted.				Y					Y	10/16/2007	10/16/2007	0	no	UNK	UNK	Flovent, Albuterol, Aciphex, Nansacort, Depo-provera injection every 3 months, Patenol, Macrobid	no	GERD, Bronchitis, UTI, seasonal allergies			1						1	Erythema; Induration; Oedema; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~u2501AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293757	10/19/2007	CA	14.0	14		F	10/19/2007	1-2 mm thin-walled vesicles noted on shoulder anterior to injection sites 2 days after injections of HPV & Influenza. No fever, rash, or other systemic symptoms.									Y	10/15/2007	10/18/2007	3	N/A	PVT	PVT		N/A	N/A			1						1	Blister; Injection site vesicles	FLU3~SANOFI PASTEUR~U2440AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1063U~UNK~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0293758	10/19/2007	MI	43.0	43		F	10/19/2007	swollen left eye, temperature of 101.7 followed by cough and nasal congestion									Y	10/16/2007	10/17/2007	1		PVT	PVT		None	eczema			1						1	Body temperature increased; Cough; Eye swelling; Nasal congestion	FLU3~SANOFI PASTEUR~V2465AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293759	10/19/2007	PA	39.0	39		M	10/19/2007	3 inch diameter area of erythema to left deltoid region. Warm to touch. No streaking. No drainage. Minimal swelling. Good, full range of motion. No changes in sensation or use of extremity. No rash, hives, respiratory complaints or itching.									Y	10/17/2007	10/19/2007	2	None at this time	UNK	PUB	Denies	Denies illness and complaints	Denies. 6 months post-partem			1						1	Erythema; Skin warm; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA052AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0293760	10/19/2007	KY	45.0	45		F	10/19/2007	5cm erythematous,edematous, tender,warm nodule to site of injection.  Ice immediately improved symptoms and decreased edema.									Y	10/19/2007	10/19/2007	0	None	PVT	PVT	None	None	None			1						1	Injection site erythema; Injection site nodule; Injection site oedema; Injection site pain; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80957~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0293761	10/19/2007	CA	1.57	1	.6	M	10/19/2007	Mother reports wheals which first appeared on legs, then spread to arms.  Mother applied Benadryl lotion to wheals, and they disappeared.  No other adverse sx. reported.									Y	10/17/2007	10/18/2007	1		UNK	UNK	none	none	Pyloric stenosis at birth, surgical correction at one month. Possible allergy to Amoxicillin (rash).			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2463AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293763	10/19/2007	VA	61.0	61		M	10/19/2007	Expired fluzone given. Expiration date: June 30 2007.									Y	10/19/2007			n/a	PUB	PVT	unknown	none	unknown			1						1	Expired drug administered	FLU3~SANOFI PASTEUR~U2189AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293776	10/19/2007					F	10/22/2007	We received via Merck USA the following information from a consumer on 10 OCT 2007: A women, no further data, received a flu shot (manufacturer and batch-number unknown) about ten years ago and experienced a paralized vocal cord and aspiration pneumonia (onset date and duration unknown). No further information available. Company assessment: Seriousness criterion: medically significant. Causality: insufficient date. Expectedness assessment according to SPC: The reported symptoms are not expected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measures necessary.									U					OTH	OTH	No other medications	Unknown			MA20071100	1						1	Pneumonia aspiration; Vocal cord paralysis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0293778	10/19/2007	PA	80.0	80		M	10/18/2007	Patient received flu shot 9/24/07 reported hoarse/wheeze/sob 10/6/07 hospitalized 10/12/07 released 10/18/07.  11/9/07 Reviewed hospital medical records which reveal patient experienced SOB, DOE, wheezing, progressive chest tightness, nausea, weakness, productive cough, sore throat, hoarseness & weight loss of 5-6 # over 2 weeks. Admitted 10/12-10/17/2007.  Pulmonary, ENT, GI & cardiac consults.  FINAL DX: Acute bronchitis.					Y	6			Y	09/24/2007	10/06/2007	12	LABS: EKG NSR w/ST elevation & T wave inversions, no acute changes.  CXR revealed CHF & right pleural effusion.  Echocardiogram revealed LV dilatation & LV dysfunction; ejection fraction 35-40%; apical akinesis; septal & anterior wall hypokinesis; mitral regurgitation; aortic regurgitation. stress test revealed severe hypokinesis & dysfunction of LV.  EGD & colon polypectomy/biopsy revealed tertiary esophageal contractions, distal esophageal/EG junction ring unable to dilate; extensive diverticulosis.  BNP 452 (H). CT of neck WNL.	OTH	PUB		None	PMH: MI, CAD, CABG 1992, BPH, Barrett espohagus, dyslipidemia, prior smoker			1						1	Dysphonia; Dyspnoea; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79240~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0293779	10/19/2007	OR	68.0	68		M	10/21/2007	-reported adverse event on 10/21. when he is felling better. - symptoms start w/ abdominal pain (close to chest). Follow w/ nausea 10/16 feeling that developed to full blown N/V on 10/17 and diarrhea - symptoms slowly subsided, i.e: ability to leave food down. - also experiencing back pain: stomach pain due to constant heaving. - feel better by 10/20 (normal/patient) this might be unrelated to vaccination since some of  8590 better/patient- lethargic *his coworker experienced similar symptoms.									Y	10/12/2007	10/16/2007	4		OTH	PVT	Detrol LA 4mg, Crestor 10mg, Amaryl 4mg, Hytrin 2mg, Lotrisone, HCT 20/25	None	Diabetes (type II), HTN, Benign prostatic Hypertrophy			1						1	Abdominal pain; Abdominal pain upper; Back pain; Diarrhoea; Lethargy; Nausea	FLU3~SANOFI PASTEUR~U2494AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293781	10/19/2007	PA	1.2	1	.2	M	10/15/2007	pruritus, erythema multiforme, w/in 5-10 minutes of administration				Y					U	10/12/2007	10/12/2007	0	None	PVT	PVT		conjunctivitis	None			1						1	Erythema multiforme; Immediate post-injection reaction; Pruritus	FLU3~SANOFI PASTEUR~U2448AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293782	10/19/2007	HI	53.0	53		F	10/19/2007	c/o dizziness, head pressure, muscle weakness, nausea, upset stomach				Y					Y	10/19/2007	10/19/2007	0		OTH	OTH		None	None			1						1	Dizziness; Headache; Muscular weakness; Nausea; Stomach discomfort	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80824~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0293784	10/19/2007	CA	7.0	7		F	10/19/2007	Left thigh red and swollen on injection site, warm to touch. Seen by Dr. today at 10:00 am.									Y	10/17/2007	10/18/2007	1		PVT	PVT			None			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2463AA~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293785	10/19/2007	CT	63.0	63		F	10/19/2007	local angioedema on right arm treated by PAC with Xyzol (escitinzene (antihistamine) 5 qd				Y						10/17/2007	10/18/2007	1		PVT	UNK	Eyedrops, Vit O and Ca; Simvastatin; EO qd	None	codeine; Avelox/ COPD, GERD, Dyslipidemia			1						1	Angioedema	FLU3~SANOFI PASTEUR~U2444AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0459F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0293786	10/19/2007	CA	42.0	42		F	10/19/2007	Afterward, severe pain working up (area of injection) then chills, fever, sweating 24-36 hours. As of 72 hours later there still is a large red welt approximately 7 inches surrounding the site. Severe pain in armpit and numbness of area near shot									U	10/16/2007	10/17/2007	1	I was told by nurse- to put ice on area which did help	PVT	PUB	None	None	None			1						1	Chills; Erythema; Hyperhidrosis; Injection site anaesthesia; Injection site pain; Injection site urticaria; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA042AA~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0961U~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293788	10/19/2007	MD	0.7	0	.7	M	10/19/2007	rectal temp of 104-105.9 10 hrs. after vaccine, stuffy nose, cough, fussy				Y						10/17/2007	10/17/2007	0	Chest x-ray done-Negative	PVT	PVT	Tylenol/ Motrin	URI symptoms				1						1	Body temperature increased; Chest X-ray normal; Cough; Irritability; Nasal congestion	FLU3~SANOFI PASTEUR~U2506AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293790	10/19/2007	CA	64.0	64		F	10/19/2007	Itchy rash at injection site penny-size diameter swelling at injection site										10/18/2007	10/19/2007	1		PUB	PUB		No	No			1						1	Injection site pruritus; Injection site rash; Injection site swelling	FLU3~SANOFI PASTEUR~U2512AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293791	10/19/2007	AZ	14.0	14		F	10/12/2007	pt felt lightheaded then fainted after receiving vaccine. pt monitored for 15 minutes vitals stable									Y	10/12/2007	10/12/2007	0	None	OTH	PUB						1						1	Dizziness; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~B0683~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HPV4~MERCK & CO. INC.~03876~1~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0293792	10/19/2007	AL	63.0	63		F	10/12/2007	Patient came into the pharmacy 10 days after the vaccine was administered complaining of arm pain and the inability to life her arm. Due to allergies, she was unable to take NSAIDS. She has taken Tylenol and applied ice to the area with no relief.										10/02/2007	10/07/2007	5		OTH	OTH	HCTZ; Synthroid; Warfarin; Zetia					1						1	Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2405AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293793	10/19/2007	OR	79.0	79		F	10/15/2007	Above patient was treated and diagnosed with Herpes (shingles) outbreak on 10/04/07 at hospital urgent care facility. She received Rx's for 1) Acyclovir 800 mg five times daily for 5 days 2) Prednisone 20 mg 2 daily for 7 days 3) Vicodin for pain				Y					U	10/03/2007				OTH	PVT	None	None	None			1						1	Herpes zoster	FLU3~SANOFI PASTEUR~U2453AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~0357U~UNK~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0293794	10/19/2007	NH	82.0	82		M	10/09/2007	(R) arm injection site red, swollen, warm to touch, area of swelling approximately 2x6 cm, pt states he first noticed it the morning after his injection. Pt instructed to apply cold packs and take an anti-inflammatory and lift affected arm pt instructed to lift arm and return if no improvement									U	10/08/2007	10/09/2007	1	None	OTH	OTH	Lasix; Metoprolol; Duoneb	Cough; SOB; COPD	NKA			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA039AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0889F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~07444~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0293796	10/19/2007	MO	55.0	55		F	10/15/2007	Burning, flushing sensation, throat tightness, fever, rash, lip and eyelid edema, nausea, vomiting, and diarrhea, overally body pain.				Y					Y	10/11/2007	10/11/2007	0	None	PVT	PVT		None	Allergy to latex, Gastric perforation x 2 with repair			1						1	Burning sensation; Diarrhoea; Eyelid oedema; Flushing; Lip oedema; Nausea; Pain; Pyrexia; Rash; Throat tightness; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80433~3~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0293797	10/19/2007	IN	66.0	66		F	10/15/2007	Really bad pain under right arm, right breast up over right shoulder, into right shoulder blade. Burning pain under right arm-slept with pillow (shot given in right arm) under arms for four days.									Y	10/06/2007	10/07/2007	1		PUB	OTH	Zantac	None				1						1	Musculoskeletal pain; Pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0293798	10/19/2007	MO	6.0	6		F	10/15/2007	10/15/07 cellulitis of (R) thigh; erythema-bright red warm to touch treated with Keflex 250 2 tsp po bid x 10 d				Y					U	10/12/2007	10/13/2007	1		OTH	OTH	None	No	None			1						1	Cellulitis; Erythema; Skin warm	FLU3~SANOFI PASTEUR~U2457EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB206AB~2~IM~LL~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1184U~2~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0293800	10/19/2007	IL	47.0	47		F	10/14/2007	After patient received flu shots 5 min later said she was having tingling sensation in hands. Symptoms went away one day later. Said she had muscle tightness in arms and leg-getting better as of 10/14/07-No treatment used by patient									Y	10/11/2007	10/11/2007	0	None	OTH	PVT		tingling in hands	None			1						1	Muscle tightness; Paraesthesia	FLU3~SANOFI PASTEUR~U2489AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293805	10/19/2007	OK	1.0	1	.0	M	10/12/2007	febrile seizures (3) 10/11/07 ER evaluation				Y					Y	10/02/2007	10/11/2007	9	CBC	PVT	PVT		None	None			1						1	Febrile convulsion; Full blood count	FLU3~SANOFI PASTEUR~UT2456CA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0224U~3~UN~LL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0745U~1~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1008U~1~UN~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0293806	10/19/2007	MI	6.0	6		F	10/15/2007	fleeting rash on face after vaccine-Rash continued to re surface for the next 48 hours									Y	10/12/2007	10/13/2007	1		OTH	OTH	None	None	mild (R) sided gross and fine motor delay			1						1	Rash	FLU3~SANOFI PASTEUR~U2439AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293807	10/19/2007	GA	25.0			F	10/15/2007	Swelling, severe pain									U					PVT	PVT	None	Swelling				1						1	Pain; Swelling	FLU3~SANOFI PASTEUR~U1244AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0380U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293808	10/19/2007	NC	4.0	4		M	10/15/2007	Facial tics, beginning 10-12-07.									N	10/08/2007	10/12/2007	4		PVT	PUB	Allegra	Allergic rhinitis, conjunctivitis	Aseptic meningitis 7/03, environmental allergies now			1						1	Tic	FLU3~SANOFI PASTEUR~U2435AA~5~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293809	10/19/2007	NE	59.0	59		F	10/16/2007	Noted pain in left arm when putting coat on at 4:30 pm. to go home from work. Unable to use arm to drive. Medicated with Tylenol with no relief. Reported symptoms 10/16/07. Left arm tender to touch, swollen at site, warm and raised. Advised to medicate with antiinflammatory and ice.									U	10/15/2007	10/15/2007	0	N/A	PVT	PVT		N/A	N/A			1						1	Injected limb mobility decreased; Injection site induration; Injection site swelling; Injection site warmth; Pain in extremity; Tenderness	FLU3~SANOFI PASTEUR~U2464AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0556U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293811	10/19/2007	IL	2.0	2	.1	F	10/16/2007	Pt developed hives after receiving flu shot				Y					Y	10/08/2007	10/08/2007	0		PVT	UNK		None				1						1	Urticaria	FLU3~SANOFI PASTEUR~UT2456AA~3~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293812	10/19/2007	VA	5.0	5		F	10/16/2007	Within an hour after vaccines, pt experiencing urticaria concentration on face (with erythematous (B) ears) extremities and trunk. No lip/tongue edema but was clearing throat and coughing. She was not in resp. distress. 12/4 to clinic vitals S4O2 96% RR 22, BP 106/70. Given 12.5 mg Benadryl 5mg Zyrtec and observed.				Y					Y	10/15/2007	10/15/2007	0		PVT	PVT	None	None	None			1						1	Cough; Erythema; Throat irritation; Urticaria	DTAP~SANOFI PASTEUR~C2765AA~5~IM~LL~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500487P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~A0273~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|VARCEL~MERCK & CO. INC.~1032U~2~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0293813	10/19/2007	TX	10.0			F	10/15/2007	Swollen rt arm with redness									Y					PVT	UNK						1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2437AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1179U~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0293814	10/19/2007	PA	81.0	81		F	10/16/2007	RASH LOWER BACK AND ON RIGHT ANKLE AND LEG. ITCH AND SWELLING ON ANKLE -SWELLING IN MOUTH GUMS WAS GIVEN TRIAMCINOLONE ACCTONIDE-CREAM FOR RASH									Y	10/01/2007	10/03/2007	2	NONE	PVT	PVT	IRON PILLS	NONE	NONE	NONE~ ()~~0.00~In Patient		1						1	Oedema mouth; Pruritus; Rash; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0293817	10/19/2007	OR	64.0	64		M	10/19/2007	Pt. developed (R) sided Bell's Palsy approx 1 mo following Zoster vaccine. He also had recent influenza vaccine (approx 2 wks) (unsure if connected).  10/23/07 Reviewed ER medical records which reveal patient experienced right posterior ear pain, HA & right facial weakness/numbness x 2 days.  Unable to close right eye & has increased right eye tearing.  Tx w/antivirals, steroids, eye lubricant.  D/C to pcp f/u. FINAL DX: right sided Bell's palsy. 10/23/07 Received vax record.  1/18/08 Provider states that patient did not receive flu vax there in 2007 but in 2006.  Pharmacy where received zoster confirmed received flu vax there 10/12/07.				Y					U	10/12/2007	10/17/2007	5	Head CT (-) LABS: head CT scan WNL.	OTH	OTH	ASA 81 mg		Prev. basal cell carcinoma PMH: basal cell carcinoma w/excision			1						1	Computerised tomogram; Facial palsy	FLU3~SANOFI PASTEUR~U2453AA~3~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293819	10/19/2007	PA	65.0	65		F	10/18/2007	Pt was given 0.5 cc Pneumovax 23 lot 0964u Exp 03/13/2009 at 1:30 pm on 10/16/07. By that evening, she had bad pain. Left arm became red, hot to touch and more and more painful. Was seen 10/18/07 at 10:00 by Dr. Left arm is pink, hot, non-tender, a little hard, shoulders to elbow. Pt was given samples Alavert, Rx for Keflex.				Y						10/16/2007	10/16/2007	0		PVT	OTH	Ultram Norvasc, Lipitor, ASA, Zetia, Premarin, Vitamin C, Vit E, Cat; Flaxseed Oil, Fish	None	Prinivil-hives, Amoxicillin-hives Mobic-HA and tight throat			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~42448AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0293820	10/19/2007	CA	4.0	4		M	10/15/2007	Pt developed significant swelling of (L) arm sternum, shoulder, (L) upper back. On exam, arm was swollen, (L) sternum still prominent and red hive seen on back. Responded to PO Benadryl. No fever.									Y	10/09/2007			None	PVT	UNK		None	None			1						1	Erythema; Swelling; Urticaria	FLU3~SANOFI PASTEUR~U2457FA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0304U~2~IM~UN~HEP A (VAQTA)~1	USA		Influenza
0293822	10/19/2007	AZ	66.0	66		F	10/19/2007	Sore upon movement Red streak Pallor Slightly warm									Y	10/17/2007	10/18/2007	1	None	OTH	PVT	Cozaar 50 mg	None	None			1						1	Erythema; Injection site streaking; Pain; Pallor; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA311BA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0293825	10/19/2007	GA	1.1	1	.1	F	10/19/2007	Received flu vaccine on 10/17/2007. On 10/18/2007 around 3 pm started breaking out in rash all over body. No fever or any other symptoms. Around 10 pm that same night child was taken to ER. ER MD advised mom to take child to doctor 2 days if no better. Noted rash all over hand, on face, arms, trunk and legs. No other				Y					Y	10/17/2007	10/18/2007	1		PUB	PUB						1						1	Rash generalised	FLU3~SANOFI PASTEUR~PMCUT2475AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293827	10/19/2007	VA				U		Seizures x 2 (short duration) fever 5 hours after vaccine administration				Y					Y	10/12/2005	10/12/2005	0		OTH	PUB		(+) Rapid strep				1						1	Convulsion	FLU3~SANOFI PASTEUR~U2461BA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293828	10/19/2007	MN	13.0	13		F	10/19/2007	Local reaction-Red Blotch rash around L deltoid injection site immed after 4-5 cm diameter-not itchy. Ice pack applied									Y	10/19/2007	10/19/2007	0		PVT	PVT	None	None	Amox-rash, seasonal allergies			1						1	Injection site rash; Local reaction; Rash macular	FLU3~SANOFI PASTEUR~U2452AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293829	10/19/2007	CA	73.0	73		M	10/18/2007	This 73 y.o. pharmacist received Fluzone flu vaccine to (L) deltoid on 10/04/07, 12 hours later noticed severe lip swelling no other symptoms. He took Benadryl p.o. on 10/05/07-a total of 8 pills (AM=3 12:10=2 PM=3); 10/06/07-Continued edema again took Benadryl 25 mg total of 8 pills (same schedule); 10/07/07 Continue edema-Benadryl-total of 4 (2 AM 2 PM) was clear of symptom on 10/08/07. No reaction at site of injection.									Y	10/04/2007	10/04/2007	0		OTH	PVT	Baby ASA qd; Vits C,E,A,B,Zn, K+	None	HTN; Anemia borderline; Basal skull fx; leg ulcers; Benign Prostatic Hypertrophy;Allergy syndrome;			1						1	Lip oedema; Lip swelling	FLU3~SANOFI PASTEUR~U2441AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293833	10/19/2007	NY	38.0	38		F	10/19/2007	I started to have a hard time catching my breath, then my heart was racing, I was light-headed and sick to my stomach.  I started a hacking cough to the point of dry heaving and then my eyes became blood shot and pus collected in the corner of both eyes.  Then I started to sweat profusely and shiver.  All of these symptoms began about 5 hours after receiving the flu shot.  I was still having a hard time breathing when I awoke the following day.  My heart was still racing, my eyes and cheeks were swollen and I was light-headed.  I felt like something was in my lungs and I couldn't take a deep breath.  I called my doctor's office and was told to go to the ER.				Y					Y	10/15/2007	10/15/2007	0	Dr. took care of me Hospital in the ER on Tuesday, 10/16/07.  She ran blood tests, did a urine sample and took chest x-rays.  I was put on an IV.  Dr. diagnosis stated: unspecified adverse effect of other drug, medicinal and biological substance, and URI and UTI.  She prescribed Bactrim.	UNK	UNK	Reclipsen- Birth Control Pill	none	heart murmur			1						1	Blood test; Chest X-ray; Chills; Cough; Dizziness; Dyspnoea; Eye discharge; Eye swelling; Hyperhidrosis; Ocular hyperaemia; Palpitations; Retching; Stomach discomfort; Swelling face; Urine analysis	FLU3~SANOFI PASTEUR~U2505AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293835	10/19/2007	OK	38.0	38		M	10/19/2007	INJECTION SITE IS RAISED/SWOLLEN.  HOT TO TOUCH. LEFT ARM IS SORE AND THERE IS A BUISE AT INJECTION SITE.									Y	10/16/2007	10/17/2007	1	NA	UNK	PVT	SINGULAR, JANUVIA, NEXIUM	NO	NASAL ALLERGIES, ALLERGIC TO BELL PEPPERS AND COCONUT			1						1	Injection site bruising; Injection site pain; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78476~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0293836	10/19/2007	PA	50.0	50		F	10/19/2007	Employee received influenza vaccine on 10/2/07 at work.  Developed rash in afternoon on 10/3/07.  Went to local hospital's emergency room on 10/4/07, received rx for Medrol dosepak, but did not have it filled because employee was feeling better.  Went to emergency room again on 10/6/07 and was given IV diphenhydramine.  Symptoms included hives, itching, lip swelling, mild shortness of breath.				Y					Y	10/02/2007	10/03/2007	1	N/A	UNK	UNK	UNKNOWN	Unknown	None			1						1	Dyspnoea; Lip swelling; Pruritus; Rash; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80685~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0293839	10/19/2007	PA	80.0	80		M	10/19/2007	Patient received influenza vaccine on 10/5/07.  Patient also receiving chemotherapy from different physician for bladder cancer.  Patient with a fever of 103 degrees F on 10/8/07.  Advised to seek attention with his oncologist or at an acute care facility.				Y					U	10/05/2007	10/08/2007	3	10/3/07 labs: WBC 4.6      RBC        4.9     HGB       12.2 L    HCT       37.0 L     MCV       76.1 L    MCH       25.0 L     MCHC      32.9          RDW       17.2 H     PLT        322     MPV        7.1 L     NEUT %    64.4         LYMPH%    21.4       MONO %    11.6 H    EOS  %     2.3        BASO %     0.3     NEUT #     2.9    LYMPH#     1.0    MONO #     0.5      EOS  #     0.1         BASO #     0.0	UNK	UNK						1						1	Basophil count decreased; Eosinophil count normal; Haematocrit decreased; Haemoglobin decreased; Lymphocyte count normal; Mean cell haemoglobin concentration; Mean cell haemoglobin decreased; Mean cell volume abnormal; Monocyte count increased; Neutrophil count normal; Platelet count normal; Pyrexia; Red blood cell count normal; Red cell distribution width increased; White blood cell count	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80685~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0293843	10/19/2007	IN	57.0	57		F	10/19/2007	10/5 Received Vaccine 10/6 reported localized reddness, generalized fatigue, chills, body aches and sweating.  10/07 Increased reddness at site, upper right arm painful and difficult to move 10/10 increased inflammation to 4 inches in diameter.									Y	10/05/2007	10/06/2007	1		UNK	PVT		No per patient	No per patient			1						1	Chills; Fatigue; Hyperhidrosis; Injected limb mobility decreased; Injection site erythema; Injection site inflammation; Injection site pain; Pain	FLU3~SANOFI PASTEUR~U2442AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0988F~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293846	10/19/2007	MD	4.0	4		M	10/19/2007	16 hours after vaccine, stuffy nose and lethargy.  24 hours after vaccine, headache, fever 101-102, slight sore throat lasting 18 hours so far.  Also lack of appetite, one episode of vomiting.  Children's Motrin given 2x for fever.									U	10/17/2007	10/18/2007	1		PUB	PUB	None	None	None			1						1	Decreased appetite; Headache; Lethargy; Nasal congestion; Pharyngolaryngeal pain; Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500486P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0293849	10/19/2007	GA	7.0	7		M	10/19/2007	wheeing and cough, started about 4 days after administration of flumist									U	10/08/2007	10/12/2007	4	none	PVT	PVT		none	prematurity EGA 31 wk, allergic rhinitis			1						1	Cough; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500487P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0293851	10/19/2007	MD	34.0	34		F	10/19/2007	Extreme pain in left deltoid, large 2 inch red circle around injection site with swelling									N	10/17/2007	10/17/2007	0	None	PUB	UNK		None	Asthma			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~Unknown~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0293853	10/19/2007	AZ	55.0	55		F	10/19/2007	PATIENT GOT INFLUENZA VACCINE & ABOUT 30 MINUTES LATER DEVELPED HIVES AND A RASH. WAS TAKEN TO OUR EMERGENCY ROOM, GIVEN VISTARIL IM, PUT UNDER OBSERVATION, AND SENT HOME WITH CHLOROPHERAMINE				Y					Y	10/18/2007	10/18/2007	0		PUB	UNK	FLUNISOLIDE, LISINOPRIL, OMEPRAZOLE, ALBUTEROL, ADVAIR, LORATADINE	NONE	NONE			1						1	Rash; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79240~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0293854	10/19/2007	CO	78.0	78		M	10/19/2007	Patient received influenza vaccination on Monday, 10/15/2007.  On Wednesday, 10/17/2007, patient broke out in hives on legs, back, groin and triceps.  Patient treated with calamine lotion and called his primary care physician on Friday.  He called pharmacy after talking to his PCP and informed us of his reaction.  He said the hives are improving and foresees no further treatment necessary.									Y	10/15/2007	10/17/2007	2	N/A	UNK	UNK	Flomax, warfarin, Proscar	No	N/A			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2488AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293855	10/19/2007	NY	25.0	25		F	10/19/2007	I graduated with honors: Dean's list, Mentoring Program Etc. After that my passion was and will always be the Medical Field so at the young age of TWENTYFIVE, I decided to become a part of a School of Radiography, so that I could have a specialty and manage a department in the hospital. I allotted myself ten dollars a week for food and took a loan for the school and that's where my story begins or ends, shall I say. AT the young age of 25, I attended School of Radiography and was maintaining an A, average and bets were placed that I would be the Valedictorian. It was extremely intensive, ten classes a semester and clinical all afternoon. I studied five hours a day. Close to a year into the program, we were instructed to have vaccinations. They told me side -effects could be flu, fever, soar throat. We were told that we did not have to but if we did not we could not continue with the program. After working so hard I was scared not to complete the program as I knew my family was leaving the country and I had to make a life for myself. We were instructed to go to the clinical area and wait for our turn. I remember when it was my turn the nurse asked the doctor if it was okay to give me all the injections at one time- he paused and stated yes. I was given MMR, Hepatitis, and Influenza that day and that is when my life took a drastic change. Many of us starting with the next day had flu-like symptoms, which started changing everyday. Many of us became disabled that day; THE FORGOTTEN PEOPLE, I CALL US AS THE STORY OF HOW OUR LIFES WERE FOREVER CHANGED AND CONTINUE TO BE. FACTS : I STARTED HAVING BURNING IN MY LEGS TO THE POINT THAT I COULDN'T WEAR PANTS, SOCKS, BLANKETS; NOTHING COULD TOUCH MY LEGS. IT FELT LIKE SOMEONE WAS HOLDING HOT IRONS ON MY LEGS, THE PAIN WOULD NOT STOP. I STARTED HAVING SENSATATIONS OF ANTS CRAWLING ALL OVER MY BODY, IN MY EARS, EYEBALLS, EVERYWHERE; IT WOULD NOT STOP. MY SKIN WOULD BUBBLE; I CALL IT, AS IF A BABY WAS KICKING AND YOU COULD FEEL IT AND ACTUALLY SEE IT. MANY OTHER STUDENTS STARTED REPORTING SIMILAR SYMPTOMS ALL NEUROLOGICAL, YET DIFFERENT, BLADDER PARALYSIS-HAD TO CATHETERIZE HERSELF FOR 6 MONTHS AFTER MISSING 4 MONTHS OF SCHOOL. OTHERS WERE FAINTING, SUFFERING WITH TINGLING SENSATATIONS, ANT LIKE SENSATATIONS, HEARING LOSS ETC. We all started reporting these symptoms to the school and they were sending us to the clinic part for us to be evaluated. Everyone was at a loss at that time since vaccines weren't known to cause Autism, Neurological disorders, Gillian Bar Syndrome. I went to clinic as that was the insurance I had. Orthopedics started with: X-rays Nuclear Scans- I was radioactive for 2 days and had to stay away from children Cat Scans Emg's Electroencephalograms Myelogram- I went into anaphylactic shock and almost died at hospital. Skin grafts Venuous flow tests, etc  No one knew what was wrong; I was put on Massive doses of painkillers: 180 pills of Soma a month Vicodin ES 750mg ,TID Voltaren Celebrex Viox Flexoril Percocet You name it, I was on it and the burning would not stop, not for a minute, I was losing my mind. I was given a walker, leg braces, arm braces and could barely ambulate; the other problem was I couldn't wear clothes below the waist. They didn't know what to do and kept sending me home with more medicine. My nickname there was BIONIC WOMAN.  Eventually, I wanted to die just to stop the pain and a neurologist named DR. found me in the staircase crying at clinic and decided to do an exam. He felt sure and called my family in to announce that I had Multiple Sclerosis and 95% chances of never walking again; All this when I was only 25 years old.  I woke up one morning to my family practically breaking down the door, and as I crawled to answer it they stated I had called everyone crying I didn't want to live anymore and was saying goodbye to them during the night. I have no recollection of that event. They also discovered I had bruises all over my body from apparently falling out of bed repeatedly, which I do not recall. My family didn't know how to help as they were emigrants and were not familiar with the medical system. I had exhausted the $40,000.00 on medical fees; I worked to save from the age of 13 on. I had to sell my car, which, I purchased new and was paid for to travel to school and back, and shortly I was going to be homeless.  I had to crawl to brush my teeth, crawl to try and shower, lived without toilet paper for days, clean towels etc. My family lived in another country and they were feeling guilty as if they did something wrong; genetically. They were either in denial or sobbing.  Eventually, I started feeling that I couldn't crawl to leave the house to see my Neurologist because there was not enough air and I couldn't breath. My father offered to carry me; he said he would protect me. My family knew I was deteriorating being left in a bed for two years with no physical therapy and tons of medications. We were following the doctors' orders. Finally, my family called the doctors to tell them this and I was told I needed a Psychiatrist and therapy, on top, I started having PANIC ATTACKS, which at that time, I didn't know what they were and thought my life was ending. My family took me to another Hospital for a second opinion.  I underwent more testing and the Chief Resident Neurologist-Dr.  felt I had a POST-PERIPHERAL MYELOPATHY FROM THE VACCINES AND WROTE IT IN HIS CHART. MY MEDICATIONS WERE SWITCHED WHICH CAUSED HORRIBLE WITHDRAWLS. THE NEW COCKTAIL WAS: o TEGRATOL-BLOOD TESTS EVERY MONTH FOR THIS MEDICATION o ANTI-DEPRESSANTS FOR PAIN AND DEPRESSION-WHICH I HAD SEVERE SIDE- EFFECTS TO AT LEAST TEN OF THEM, WHICH I TRIED, PALPATATION, CYANOSIS, SYNCOPE, GAINING 40 POUNDS, ETC o OXAZEPAM FOR ANXIETY o INDERAL  I BECAME A CRAWLING JUNKEY. MY FIVE YEAR RELATIONSHIP AND ENGAGEMENT ENDED, HE COULD NOT HANDLE SEEING ME IN A WHEEL CHAIR, MANY MEMBERS OF MY FAMILY COULD NOT FACE ME, I LOST ALL MY FRIENDS AS THEIR LIVES WENT ON AND MINE WAS DETERIORATING.  WE STARTED LOOKING FOR ALTERNATIVE TREATMENTS WHICH WERE COSTLY, I BEGAN A REGIME OF: o CHIROPRACTIC-DR. - 5 times a week o Accupuncture-2x a week, that was all my family could afford o Brain scans and continuous scans of every part of my body. o Referred to Orthopedic Surgeon-Dr. o Started therapy for 5 years, which saved my life; Center for Psychotherapy and later B Center for Psychotherapy. Eventually my family went from being well-off to having to sell their furniture to pay for all of these treatments, let alone I had two other sisters that had to be cared for. They sold our house I cried for months, and years.  I had applied for disability and had been turned down two times which is there protocol. By the third time and appearing in front of the judge and representing myself, I was deemed disabled due to having Guillian Bar Syndrome, but not the usual motor loss; I had SENSORY PARASTHESIA AND DYSASTHESIA, WHICH WAS STILL NOT PART OF THE ICD-9 CLASSIFICATIONS OF CODES.  Dr. (Orthopedic Surgeon) was treating me with multiple Trigger Point injections; I estimate to have had over five hundred and I had been on a cocktail of medications. Winters were hard because I was not able to wear pants, socks, use sheets or blankets etc. The Doctor, not knowing what else to do decided to try a cream called Zostrix HP, used for Diabetic burning or Shingle Patients, which reduced the burning and I could wear clothes again on my lower extremities, given time. I used to have to buy socks that cost Thirty dollars a pair due to their softness. This also made it easier to wear the braces since the fabric intensified the burning at that time. Finally, the orthopedic surgeon called me one night and said he couldn't treat me anymore because all the treatments weren't really helping, I had put on 40 pounds from all the injections and he could not do more than what he had done. A week later, he called to tell me he heard about a pain center and gave me the information. All of this went on for about 6 years before I found Dr. And Chronic Pain Anesthesiologist.  Life started getting better as I started treating with him. My medication cocktail became: o Paxil 70 mg daily o Vicodin ES 750 mg , TID o Protonix- stomach was destroyed with all medications o Oxazepam 15mg, TID o Celebrex BID o Zoxtrix HP daily, but could not shave legs to use this cream  My cocktail was now less and I began having Ambulatory Epidurals under anesthesia. In total over 8 more years I had: o 14 ambulatory epidurals under anesthesia o 2 Arthroscopic knee surgeries; Dr. - Orthopedic Surgeon, 300 Trigger point injections or more  It was after eight years of treatment with him, I was finally able to walk a block and stop to rest from the pain. Every few months, I was able to walk another block, and this continued until the year of 2000. Ten years later I finally could stand long enough to brush my teeth, partly through a shower, I could wear clothes. Thank god too, because we could not afford the Chiropractors and Acupuncture anymore and my father suffered a heart- attack and had a quintuple bypass surgery and he could not carry me or drive me anymore.  I NEEDED HELP AND STARTED GETTING INFORMED AS IT HAD BEEN TOO PAINFUL FOR ME IN THE PAST, AND EVEN WRITING THIS LETTER SETS ME INTO TEARS; I DO IT FOR MY LITTLE MIRACLE, MY FOUR YEAR OLD DAUGHTER, BECAUSE I KNOW I CAN NEVER GIVE HER THE LIFE I COULD HAVE. I CONTACTED OUR CONGRESSMAN,  WHO I AM GRATEFUL TO AS HE CONTACTED SUPTEINTENDANT - DEPARTMENT OF INSURANCE AND THE DEPARTMENT OF HEALTH; AND OTHERS WERE BEING FOUGHT BY ME REGARDING MY DISABILITY; ALL OF THE MIS-DIAGNOSES; NOW THAT INFORMATION WAS AVAILABLE, THIMEROSAL WAS A HOT TOPIC.  MY DOCTORS WERE WILLING TO TESTIFY AND IT WAS REPORTED TO THE CDC AND THE VACCINE INJURY HOTLINE ONCE THESE WERE CREATED. THERE WERENT THE LAWS WHEN I WAS INJURED THAT THE DOCTORS HAD TO REPORT IT TO THE CDC, THERE WAS NO VAERS, WHICH I AM STILL NOT A PART OF. IT APPEARS THAT THE QUALITY OF LIFE IS MORE IMPORTANT FOR A CHILD THAN AN ADULT. IT SHOULDN'T MATTER AT WHAT AGE THIS OCCURS, WHAT IS WORSE A CHILD WHO DOESN'T KNOW LIFE YET, OR SOMEONE'S LIFE THAT IS RIPPED APART?  LAWYERS THAN SAID THE DOCTORS WOULD BE FIRED IF THEY TESTIFIED AND THIS WAS COMMON PRACTICE with VAERS, AS THE GOVT WAS COVERING UP. MY DOCTORS WILL AND STILL WILL, IF NEED BE AFTER THE HORROR THEY SAW ME GO THROUGH. I HAVE SPOKEN TO THEM RECENTLY ABOUT THIS AND THEY ARE MORE THAN HAPPY TO TAKE THE RISK AS THEY FEEL A VIBRANT, BRAVE, YOUNG WOMAN WAS LED TO ALMOST DEATH, DISABILITY, AND POVERTY. YOU GET PENALIZED FOR GOING TO COLLEGE BECAUSE IF YOU DIDN'T CONTRIBUTE ENOUGH IN TAXES YOU CAN ONLY GET $400. A MONTH AND FOOD STAMPS, WHICH DO NOT COVER TOILET PAPER, SOAP, LAUNDRY DETERGENT, PAPER TOWELS, CLOTHING ETC. I HAVE ALL THE DOCUMENTS SUPPORTING THESE LETTERS FROM Congress AND NOTHING WAS EVER DONE ABOUT IT FOR ME OR BY VAERS, CDC ETC. THE LETTERS KEPT STATING I NEEDED PERMISSION ON A FEDERAL LEVEL TO BE ACCEPTED TO THE VACCINE ADVERSE EFFECT FUND. NO ONE WAS EVER ABLE TO BE REACHED, ALTHOUGH IT WAS REPORTED AND I WAS GIVEN A SPECIFIC NUMBER TO REFER TO. IT APPEARS THAT THE VACCINES HAVE BEEN ADDED AND ARE BACK-DATED TO THIS PERIOD now. I HAVE BEEN INSTRUCTED TO WRITE THIS LETTER TO MERC PHARMACEUTICALS LEGAL DEPARTMENT TO NOTIFY THEM AND TO ASK FOR COMPENSATION TO AVOID LAUNCHING A CLASS ACTION LAWSUIT. I RECEIVED A PHONE CALL FROM A WOMAN, WHO STATED SHE WAS a PERSONAL ASSISTANT  AND IF THIS DID NOT RESOLVE ANYTHING, someone WOULD BE HANDLING THIS AS A PERSONAL MATTER AND never did anything or answered my calls afterwards.  I AM STILL DISABLED TO DATE AND HAVE A FOUR YEAR OLD TO SUPPORT. I HAVE HAD FOURTEEN AMBULATORY SURGERIES, 3 SURGERIES, AND HAVE TAKEN THOUSANDS OF PRESCRIBED MEDICATIONS FOR THIS WHEN MY LIFE SUDDENLY CHANGED AT THE EARLY AGE OF TWENTYFIVE, AFTER ONE YEAR OF ENTERING THIS SCHOOL AFTER COMPLETING MY B.S. DEGREE. IN ADDITION, IN 2000, I HAD MY GALL BLADDER REMOVED HOSPITAL BY DR.; WHO STATES THAT I HAD BILIARY DYSKENESIA DUE TO THE AMOUNT OF MEDICATION I HAD BEEN ON FOR YEARS. HE FELT IT WAS VERY RARE FOR SOMEONE MY AGE TO HAVE THIS. I HAVE SUFFERED MANY YEARS NOW AND CONTINUE TO DO SO.I AM BEGGING FOR A CHANCE TO AFFORD MY YOUNG CHILD A BETTER QUALITY OF LIFE AS I LIVE ON A FIXED INCOME, A SMALL ONE FROM SOCIAL SECURITY DISABILITY. I AM A SINGLE MOTHER, AND HAD TO MOVE, TO BE NEAR MY FAMILY AS I NEED THEIR HELP IN RAISING HER DUE TO MY LIMITED ABILITIES. SHE IS MY REASON FOR LIVING AND TO ME A MIRACLE FOR ALL THE HELL I HAVE BEEN THROUGH. I DO NOT WANT HER TO BE RAISED IN POVERTY, SHE ALREADY SEES ME SUFFER, TAKE MEDICATION, CONSTANT DOCTORS' APPOINTMENTS, BRACES, ETC. MY LIFE WAS STOLEN FROM ME I WANT AND BEG FOR THE CHANCE TO GIVE HER A GOOD LIFE. I AM NOT JUST A NUMBER. MY BS, CRA, AAS, MA, AS I CONTINUED MY STUDIES WHEN I AM ABLE TO AND CLEAR ENOUGH SINCE THE MEDICATION MAKES YOU FORGETFUL, LACK OF ENERGY, ETC. MY CURRENT DIAGNOSES ARE: GUILLIAN BAR SYNDROME MYELOPATHY FIBROMYALGIA WITH MYOFACIAL RADICULOPATHY MY CURRENT MEDICATION REGIME: PAXIL 70MG DAILY FOR BURNING AND ANTI-DEPRESSANT PROPERTIES LYRICA 50MG, TID-NEUROMUSCULAR ALERTEC-MODOFANIL  100MG, BID-ENERGY;ANTI-NARCOLEPTIC AND EXPENSIVE CLONAZEPAM, 50MG, BID VICODIN 750MG, TID  I AM NOW BEING EVALUATED BY HOSPITAL-CHRONIC PAIN CENTER BY: DR.-RHEUMOTOLOGIST AND DR.; WHO ARE EXTREMELY CONCERNED ABOUT THE MIX OF MEDICATIONS HAS ME ON AND THAT THE SIDE EFFECTS MAY BE HORRIFIC AND I AM UNDERGOING EXAMS AGAIN. I AM NOW FUNCTIONAL, WITH MEDICATIONS, BUT MY CONDITION VARIES WITH WEATHER ETC, AND SOME DAYS ARE MUCH HARDER THAN OTHERS. I WILL BE ON MEDICATION THE REST OF MY LIFE WHICH I FOUGHT VERY HARD NOT TO BE ON. I FINALLY CHOSE PERHAPS A SHORTER LIFE BUT A MORE FUNCTIONALONE. WHOEVER READS THIS, PLEASE FIND THE COMPASSION IN YOUR HEART TO HELP. I DID NOT ASK FOR THIS AND WILL SUFFER IN PAIN PHYSICALLY AND EMOTIONALLY UNTIL I DIE. I AM NOW FORTYTWO YEARS OLD.I AM TEMPORARILY RESIDING IN ANOTHER COUNTRY FOR ONE YEAR AS I CANNOT TAKE CARE OF MYSELF AT TIMES AND MY OLD-AGED PARENTS HELP ME. I BEG AND ASK THAT YOU FIND THE MERCY, COMPASSION AND KINDNESS IN YOUR HEART TO DO SOMETHING TO COMPENSATE ME COMPENSATE ME FOR WHAT I HAVE BEEN THROUGH AND WILL CONTINUE TO UNTIL I DIE.  MY MAIN REASON IS TO GIVE MY DAUGHTER A CHANCE OF HAVING A GOOD LIFE, WITH SECURITY. IF SOMETHING HAPPENS TO ME, SO SHE CAN GO TO SCHOOL AND COLLEGE, SO WE DON'T HAVE TO WAIT ON FOOD LINES ANYMORE OR TAKE FURNITURE FROM THE GARBAGE ANYMORE. I BEG, AND ASK AS A MOTHER, WHO WANTS TO SEE HER CHILD NOT SUFFER FOR THE HORRORS THAT HAPPENED TO ME. IT IS MY RIGHT, AND AN OBLIGATION FROM YOUR COMPANY TO DO SO AS YOU ARE A BIG PART OF THE CAUSE. I ASK FOR WHAT IS FAIR, I TRUST IN GOD, AND HE SEES ALL AND I KNOW THAT JUSTICE WILL PREVAIL.  I CANNOT AFFORD LIFE INSURANCE; APT INSURANCE ETC. PLEASE FIND IT IN YOUR HEART TO DO THE RIGHT THING. I COULD HAVE APPROACHED THIS WITH A CLASS ACTION LAWSUIT; I HAVE NOT. I HAVE COME TO YOU TO SEEK RETRIBUTION FOR WHAT I HAVE SUFFERED THROUGH AND WISH ONLY THAT YOU MAY NEVER KNOW THE HORRORS OF PAIN THE BRAIN CAN CREATE.  YOU HAVE BEEN FORTUNATE TO BE IN A BETTER POSITION THAN MYSELF. THIS DID NOT HAPPEN TO ME BECAUSE OF GENETICS, OR ON ITS OWN. IT WAS INDUCED BY THE VACCINES THEREFORE; IT IS YOUR RESPONSIBILITY SINCE YOU CREATED THESE. AGAIN, IT DESTROYED MANY LIVES; I AM ONE PERSON ASKING, PRIVATELY, WITHOUT INCLUDING THE OTHER CLASS MEMBERS.  I HAVE SPOKEN TO MANY LAWYERS WHO ADVISE ME DIFFERENTLY BUT I AM TRYING TO HAVE FAITH IN YOUR COMPANY AND IN DOING THE RIGHT THING FOR ME AS WELL AS FOR THE LIFE OF AN INNOCENT FOUR YEAR OLD. DON'T CONDEMN HER TO A LIFE THAT WAS BESTOWED UPON ME. I WAS A LEADER AND WILL CONTINUE TO BE IF I HAVE TO. MY VOICE WILL BE HEARD, BOOKS WILL BE WRITTEN.  I ASK FOR COMPENSATION FOR THE EIGHTEEN YEARS OF SUFFERING AND THE REST OF MY LIFE ON MEDICATION. I DON'T KNOW HOW LONG I WILL HAVE TO LIVE BUT I WANT TO KNOW MY DAUGHTER WILL NOT HAVE TO WORRY. I HAVE ENOUGH DEGREES THAT I SHOULD AND COULD HAVE BEEN SUCCESSFUL BUT YOUR VACCINES TOOK THAT AWAY. I ASK THAT YOU FAVOR MY REQUEST FOR MY FAMILY, MY PARENTS AND THEIR SUFFERING THROUGH THIS, AND MOST OF ALL FOR THE REMAINDER OF MY LIFE. I TRUST YOUR FAIRNESS, INTEGRITY, CARING FOR THE LIFE OF A HUMAN BEING. THANK YOU, FOR YOUR ATTENTION AND UNDERSTANDING.  01/07/2008 Records received from pt for several visits and diagnostic tests in 1996.  OV 9/26/06 with c/o severe shoulder pain in the paracervical area on the R.  PE reveals limited forward flexion and lateral rotation.  Pt is neurologically intact in both upper extremities. Impression:  impingement syndrome of the R shoulder with tendinitis of the supraspinatus tendon, bicipital tenosynovitis and glenohumeral effusion. Secondary myofascial pain in the paracervical and upper trapezial region.  OV 10/14/1996 with PMH of probable myelopathy of unknown etiology with persistant burning pain in lower extremities.    On PE gait is slow and cautious. Pain noted in R hip and back. Tenderness to palpation in low back and neck.  Spasm noted radiating from the the neck.  Sensation intact. Muscle tone normal. Exam does not reveal neurological defecit.			Y	Y	Y	5	Y	Y	N	03/17/1991	03/18/1991	1	Mri-whole body,Nuclear scans-entire body, Myelogram, Electroencephalogram, Emgs'.X-rays, Nerve conduction studies,EKG, HOLTER MONITOR, ULTRASOUND, CATSCAN, SPINAL TAP,  Labs and Diagnostics:  EMG (11/5/96) shows delay of the R relative to L side c/w some C7 radiculopathy.  MRI R shoulder 6/24/96- Impingement and tendinitis supraspinatus tendon. Biceps tenosynovitis.  Glenohumoral joint effusion.  MRI R knee- Suprapatellar effusion.  No evidence of meniscal tear.  Intact ligaments	UNK	UNK	NONE	NONE. THIS HAS BEEN REPORTED SEVERAL TIMES; ABOVE INFORMATION LISTED. ALSO REPORTED TO 911 SHOTS, CDC, DEPT OF HEALTH, DEPT OF INSURANCE. THERE WERE NO PROTOCALS AT THAT TIME. WE WERE REQUIRED TO TAKE THESE VACCINES AS PART OF BEING STUDENTS AT  SCHOOL OF RADIOGRAPHY, AFTER COLLEGE CLOSE TO ONE YEAR AFTER THE PROGRAM BEGAN. THEY SENT US TO THE CLINIC AT HOSPITAL.	NONE Multiple car accidents reported in 1995 and 1996 with knee, neck, and shoulder injuries.	MYELOPATHY, GUILLIAN GARRET, FIBROMYALGIA, POST-PERIPHERAL NEURALGIA~Measles + Mumps + Rubella (Virivac)~1~91.30~Patient|PATIENT		1						1	Amnesia; Anaphylactic shock; Anxiety; Arthroscopic surgery; Burning sensation; Computerised tomogram; Contusion; Crying; Cyanosis; Deafness; Depression; Dysaesthesia; Dyspnoea; Electrocardiogram; Electrocardiogram ambulatory; Electroencephalogram; Electromyogram; Fall; Fibromyalgia; Formication; Gait disturbance; Gallbladder operation; Influenza like illness; Lumbar puncture; Multiple sclerosis; Myelopathy; Nerve conduction studies; Nuclear magnetic resonance imaging; Pain; Pain in extremity; Palpitations; Panic attack; Paraesthesia; Radiculopathy; Spinal myelogram; Surgery; Syncope; Ultrasound scan; Walking aid user; Weight increased; X-ray; Abasia; Anaphylactic shock; Bone scan; Burning sensation; Electrocardiogram; Electroencephalogram; Electromyogram; Fibromyalgia; Formication; Influenza like illness; Myelopathy; Myofascial pain syndrome; Nerve conduction studies; Neurological symptom; Nuclear magnetic resonance imaging; Paraesthesia; Spinal myelogram	FLUX~UNKNOWN MANUFACTURER~?~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~MERCK & CO. INC.~?~1~IM~RA~HEP B (RECOMBIVAX HB)~1|MMRV~MERCK & CO. INC.~?~1~IM~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|FLU3~PFIZER\WYETH~at hospital~2~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~2|HEP~MERCK & CO. INC.~at hospital~3~IM~RA~HEP B (RECOMBIVAX HB)~2|MMR~MERCK & CO. INC.~at hospital~2~IM~LA~MEASLES + MUMPS + RUBELLA (MMR II)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0294715	10/19/2007	OH	0.5	0	.5	M	10/23/2007	16 hours, inconsolable cry. Zero sleep. 100 degree max temp, no other signs of infection. Started 30 minutes after injection.				Y						10/22/2007	10/22/2007	0		PVT	PUB		None	None			1						1	Body temperature increased; Crying; Immediate post-injection reaction	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B130AA~2~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2460AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF110AA~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B47300B~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0667U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0293856	10/20/2007	IA	52.0	52		M	10/20/2007	Zostavax, MMR, Proquad Safety RE: Shingles information from Merck From:  Sent:Sat 10/20/07 1:04 AM   I am 55 years old, and by using myself as a human guinea-pig in vaccine experiments I have established that Zostavax (multiple doses) is safe for a guy my age, even when given one day after another, and when given in combination with MMR.  I have also had ProQuad, which is perfectly safe for my age group (at least as demonstrated by my example), and I have had dozens and dozens of MMR injections since January of 2005, all of which were perfectly safe even when given every day for weeks on end.  I have received MMR both before and after two or three dozen administrations of Flu-Zone (with 25 micrograms of mercury per dose), demonstrating that mercurics in conjunction with MMR don't cause autism (unless some other unexplained non-vaccine problem is at work).  I also have had about a dozen Td-tetanus shots since January 2005 (both from health dept. and Sanofi-Aventis/Aventis Pasteur) and am living proof that introducing that material into the mix is not injurious either, as demonstrated in this human.     I have read some of the transcripts from the case heard a few months back and can see the allegations are off-target, as shown by my experience.  If the judges (grand-masters), with their obviously limited knowledge of medicine, could benefit from a demonstration of the foregoing guinea-pig realities, I'd be happy to show them what I am talking about, ditto for the claimants, their lawyers, or the respondent attorneys.  Crohn's disease (or reasonable facsimile thereof) is evidence for an overactive autoimmune condition rather than an immune deficiency.  Since my various vaccine administrations have helped noticeably decrease my autoimmune problems at times, it is possible that re-administration of MMR could paradoxically diminish her Crohn's.  My pathophysiology involves predominantly eosinophils, along with lymphocytes and neutrophils.        -------------------------------------------------------------------------------- Date: Wed, 17 Oct 2007 21:31:15 -0400 From:  To:  Subject: Shingles information from Merck  Read Full Prescribing Information    ZOSTAVAX is a vaccine that is used for adults 60 years of age or older to prevent Shingles.   --------------------------------------------------------------------------------   Patient Information about ZOSTAVAX   --------------------------------------------------------------------------------   (pronounced ZOS tah vax) Generic name: Zoster Vaccine Live  You should read this summary of information about ZOSTAVAX before you are vaccinated. If you have any questions about ZOSTAVAX after reading the following information, you should ask your healthcare provider. This information does not take the place of talking about ZOSTAVAX with your doctor, nurse, or other healthcare provider. Only your healthcare provider can decide if ZOSTAVAX is right for you.  Learn more about ZOSTAVAX by clicking on each link below:  What is ZOSTAVAX and how does it work?  What do I need to know about Shingles and the virus that causes it?  Who should not get ZOSTAVAX?  How is ZOSTAVAX given?  What should I tell my healthcare provider before I get ZOSTAVAX?  What are the possible side effects of ZOSTAVAX?  What are the ingredients of ZOSTAVAX?  What else should I know about ZOSTAVAX?     What is ZOSTAVAX and how does it work?   --------------------------------------------------------------------------------   ZOSTAVAX is a vaccine that is used for adults 60 years of age or older to prevent Shingles (also known as zoster). ZOSTAVAX contains a weakened chickenpox virus (varicella-zoster virus).  ZOSTAVAX works by helping your immune system protect you from getting Shingles. If you do get Shingles even though you have been vaccinated, ZOSTAVAX may help prevent the nerve pain that can follow Shingles in some people. ZOSTAVAX may not protect everyone who gets the vaccine. ZOSTAVAX cannot be used to treat Shingles once you have it.  Back to Top  What do I need to know about  Shingles and the virus that causes it?   --------------------------------------------------------------------------------   Shingles is caused by the same virus that causes chickenpox. Once you have had chickenpox, the virus can stay in your nervous system for many years. For reasons that are not fully understood, the virus may become active again and give you Shingles. Age and problems with the immune system may increase your chances of getting Shingles.  Shingles is a rash that is usually on one side of the body. The rash begins as a cluster of small red spots that often blister. The rash can be painful. Shingles rashes usually last up to 30 days and, for most people, the pain associated with the rash lessens as it heals.  Back to Top  Who should not get ZOSTAVAX?   --------------------------------------------------------------------------------   You should not get ZOSTAVAX if you:  are allergic to any of its ingredients. are allergic to gelatin or neomycin. have a weakened immune system (for example, an immune deficiency, leukemia, lymphoma, or HIV/AIDS). take high doses of steroids by injection or by mouth. are pregnant or plan to get pregnant.   You should not get ZOSTAVAX to prevent chickenpox.  Children should not get ZOSTAVAX.  Back to Top  How is ZOSTAVAX given?   --------------------------------------------------------------------------------   ZOSTAVAX is given as a single dose by injection under the skin.  Back to Top  What should I tell my healthcare  provider before I get ZOSTAVAX?   --------------------------------------------------------------------------------   You should tell your healthcare provider if you:  have or have had any medical problems. take any medicines, including non-prescription medicines, and dietary supplements. have any allergies, including allergies to neomycin or gelatin. had an allergic reaction to another vaccine. are pregnant or plan to become pregnant. are breast-feeding.   Tell your healthcare provider if you expect to be in close contact (including household contact) with newborn infants, someone who may be pregnant and has not had chickenpox or been vaccinated against chickenpox, or someone who has problems with their immune system. Your healthcare provider can tell you what situations you may need to avoid.  Back to Top  What are the possible side effects of ZOSTAVAX?   --------------------------------------------------------------------------------   The most common side effects that people in the clinical studies reported after receiving the vaccine include:  redness, pain, itching, swelling, warmth, or bruising where the shot was given. headache.   Tell your healthcare provider if you have any new or unusual symptoms after you receive ZOSTAVAX.  Back to Top  What are the ingredients of ZOSTAVAX?   --------------------------------------------------------------------------------   Active Ingredient: a weakened form of the varicella-zoster virus. Inactive Ingredients: sucrose, hydrolyzed porcine gelatin, sodium chloride, monosodium L-glutamate, sodium phosphate dibasic, potassium phosphate monobasic, potassium chloride.  Back to Top  What else should I know about ZOSTAVAX?   --------------------------------------------------------------------------------   Vaccinees and their healthcare providers are encouraged to call to report any exposure to ZOSTAVAX during pregnancy.  This information summarizes important information about ZOSTAVAX.  If you would like more information, talk to your healthcare provider or visit the website. Back to Top  For additional information, please read the Prescribing Information.  Rx Only Issued July 2007  ZOSTAVAX is a registered trademark of Merck & Co., Inc. Copyright © 2007 Merck & Co., Inc. All rights reserved.     Please read our privacy policy to learn about how Merck protects your personal information.  If you think you have received this message in error, or if for any reason you wish to stop receiving e-mails from shinglesinfo.com, simply click here   20752560(1)-10/07-ZOS       ------------------------------------------------------------------------------ Notice: This e-mail message, together with any attachments, contains information of Merck & Co., Inc. and/or its affiliates (which may be known outside this country as Merck Frosst, Merck Sharp & Dohme or MSD or as Banyu - direct contact information for affiliates is  available that may be  confidential, proprietary copyrighted and/or legally privileged. It is  intended solely for the use of the individual or entity named on this  message. If you are not the intended recipient, and have received this  message in error, please notify us immediately by reply e-mail and then  delete it from your system.  ------------------------------------------------------------------------------    -------------------------------------------------------------------------------- Climb to the top of the charts!  Play:  the word scramble challenge with star power. Play Now! No message is selected Click any message to view it in the reading pane. Attachments, pictures, and links from unknown senders are blocked to help protect your privacy and safety.  To show messages automatically when you select a folder, change your reading pane settings 1 message is selected Mark as safe | Mark as unsafe									U	01/10/2005			Multiple vaccinations alleviate autoimmune disease, and are perfectly safe.	UNK	UNK						1						1	Herpes zoster; Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|MM~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS (MM-VAX)~1|TD~SANOFI PASTEUR~~UNK~~~TD ADSORBED (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~~UNK~~~VARICELLA (VARIVAX)~1	USA		Influenza
0293857	10/20/2007	ID	61.0	61		F	10/20/2007	Within an hour, localized pain.  Within two hours, general achiness, coughing, running nose, earaches, sore throat, intense itching of forearms.										10/19/2007	10/19/2007	0		PUB	PVT						1						1	Cough; Ear pain; Pain; Pharyngolaryngeal pain; Pruritus; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~~7+~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0293858	10/20/2007	NY		55		M	10/20/2007	Headache 10/19/07 AM; Dizziness 10/19/07 AM; Vomiting 10/19/07 8:15 AM.									Y	10/18/2007	10/19/2007	1		PVT	UNK		none	Heart attack 4 years ago			1						1	Dizziness; Headache; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0293860	10/20/2007	UT	11.0	11		M	10/20/2007	pt complained of HA and fever and sore arm									Y	10/15/2007	10/15/2007	0		UNK	UNK	Ritalin, zyprexa	NA	ADD			1						1	Headache; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~u2504aa~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293864	10/20/2007	OR	26.0	26		F	10/20/2007	Patient called me on the morning of 10/20/2007 to report that her left deltiod was inflamed, red, hot and sore. This occurred late last night and had not progressed since then. Area affected was about palm-sized around the area where the shot was administered and was localized. She felt fine otherwise and didn't have any chest tightness, hives or breathing problems. I instructed her to take benadryl as directed on the box, ibuprofen, and to ice the area periodically throught the day. I will follow up tomorrow morning.									U	10/19/2007	10/19/2007	0		UNK	PVT	none	none	none			1						1	Injection site erythema; Injection site inflammation; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~u2486aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293865	10/20/2007	TX	41.0	41		F	10/20/2007	Pt experienced itching sensation and hives on face, neck, and back.  Also dizziness without syncope.  Pt was placed in position of comfort, seen by in-house physician, ordered and given 50mg of benadryl IM in opposite arm as flu shot, was observed for 40 minutes. Pt stated feeling better, hives and itching resolved.				Y					Y	10/20/2007	10/20/2007	0	n/a	MIL	MIL	Pt states taking allergy medicine.	Seasonal allergies	Pt states having a history of multiple seasonal allergies and has taken allergy tests to confirm. Pt did state this has been a first occurrence of flu vaccination reaction.			1						1	Dizziness; Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA049AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0293869	10/21/2007	CA	20.0	20		M	10/21/2007	3:00 pm headache,  4:30 high fever and chills,along with hands and feet feeling numb, 6:00 throwing up,weak and dizzy,  7:00 pm lips swollen, face swollen and shallow labored breathing and a fever of 103 F, called primary care physician on call and recommended immediate transport to emergency room.				Y					Y	10/20/2007	10/20/2007	0	blood and urine test - inconclusive - all results normal	PVT	UNK	none	none	allergic to penicillin			1						1	Asthenia; Blood test; Chills; Culture urine negative; Dizziness; Headache; Hypoaesthesia; Hypoventilation; Lip swelling; Pyrexia; Swelling face; Vomiting	FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0293870	10/21/2007	GA	3.0	3		M	10/21/2007	Around two hours after flu shot, patient experienced a seizure that lasted approximately two minutes.				Y					Y	10/19/2007	10/19/2007	0	Blood, urine, CT scan.	UNK	UNK						1						1	Blood culture; Computerised tomogram; Convulsion; Culture urine	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293874	10/22/2007	CA	40.0	40		F	10/22/2007	I received the shot at about 11 a.m. on  11/20/07 at the office of my son's pediatrician; my 20-month son received it too.  Hours after the shot I started to fell dizziness, weak, like vomiting and this continued until the next day (today). Today, around mid day I vomited my hands shaked for most of the day as if I had drank a high dosage of caffine. I feel very weak and spacey/disoriented. My son seems to be okay. My ex, my son's father also received the shot at the same time that my son and I did. He says that he has felt fine. Today, I had to rest for part of the day because I did not feel well.  If this feeling continues tomorrow morning, I will go in to see a doctor. I have had the shot before but have not had this reaction. I don't know why I am feeling this way this time, I was not ill before I received it.									U	10/20/2007	10/20/2007	0		UNK	UNK	I don't take any other medications. I am otherwise in excellent health.	none	none			1						1	Asthenia; Disorientation; Dizziness; Feeling abnormal; Malaise; Tremor; Vomiting	FLUX~UNKNOWN MANUFACTURER~~6~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0293922	10/22/2007	GA	9.0	9		M	10/22/2007	wrong age appropriate vaccine given to age of child.  This vaccine is not lisenced for this child's age.									Y	10/15/2007				PUB	PVT		none known	asthma			1						1	Inappropriate schedule of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA274BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0293980	10/22/2007	WA	78.0	78		F	10/16/2007	Patient had Pneumovax and developed hematoma (on Coumadin) at local injection site. Later in week developed a redness below injection site about egg size - now resolved. Slight pinkness there, doesn't look like old blood. She only showed her arm after redness mostly resolved.									Y	10/11/2007	10/11/2007	0	None	PVT	UNK		Rotator cuff	On Coumadin			1						1	Erythema; Injection site haematoma	FLU3~SANOFI PASTEUR~U2444AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~09610~2~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293981	10/22/2007	MO	75.0	75		F	10/12/2007	Noted about 12 hours after shots, (L) arm pit tender to touch. No swelling or redness. Instructed.									U	10/11/2007	10/12/2007	1	None	OTH	OTH	None	None	None			1						1	Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78476~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1005F~2~UN~LA~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~0885U~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0293983	10/22/2007	ID	64.0	64		M	10/17/2007	Low level pain at administration time and plus 10 hours. Abdominal pain and muscular stiffness increased; took 3 aspirin. Overnight symptoms included chills, muscular aches, overheating, restlessness (30-45 minute sleeping periods). 10-17-07: Muscular aches, tired, stayed home from work.									U	10/16/2007	10/16/2007	0		OTH	OTH	Protonix; Crestor; Actos	None	None			1						1	Abdominal pain; Chills; Fatigue; Feeling hot; Musculoskeletal stiffness; Myalgia; Pain; Restlessness; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0697U~UNK~IJ~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293984	10/22/2007	MI	82.0	82		F	10/04/2007	Right eye lid and under eye was red and swollen. She said there was a rash on her forehead that had pretty much gone away-just a little red but no rash				Y					Y	10/02/2007	10/03/2007	1	Regular erythematous papular facial rash-Dr reviewed symptomatic measures. Prescribed Medrol dosepak and Benadryl as needed-see attached	OTH	OTH	None					1						1	Erythema of eyelid; Eyelid oedema; Rash; Rash erythematous; Rash papular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA294EA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0293986	10/22/2007	IL	84.0	84		F		Erythematous, Edematous rash extending from right shoulder down to right elbow. Tender to touch Benadryl, ice to site, ibuprofen Pt noted discomfort to arm within 1-2 hours after admission Required Medrol dose pak to alleviate symptoms.									Y	10/09/2007				PVT	PVT	Meclizine Prevacid, Lipitor, Nifedical, Glipizide, Metformin, Lamisil Cream	None	Sulfa allergy/DM II, Idiopathic Pulmonary fibrosis.			1						1	Rash erythematous; Tenderness	FLU3~SANOFI PASTEUR~U2499AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0200U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0293988	10/22/2007	MD	40.0	40		F		Got flu vaccine at 1330. Around 2000 started wheezing and chest got tight. Used home nebulizer without relief. Took Benadryl 25 mg. Not getting better. Took another Benadryl 25 mg and nebulizer treatment. Not much better went to ED.				Y					Y	10/15/2007	10/15/2007	0	None	PUB	PVT	Nexium, Serevent BIO Albuterol PRN Zyrtec	No	asthma, Reflux allergies-environmental			1						1	Chest discomfort; Wheezing	FLU3~SANOFI PASTEUR~U2463AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293989	10/22/2007	NC	84.0	84		F	10/15/2007	Fever; Dyspnea; Malaise; Exhaustion Normal labs and x rays				Y						10/02/2007	10/03/2007	1	Chemistry and Hematology	PVT	PVT			Bronchiolitis Obliterans			1						1	Dyspnoea; Fatigue; Haematology test; Laboratory test; Laboratory test normal; Malaise; Pyrexia; X-ray normal	FLU3~SANOFI PASTEUR~U2462AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293990	10/22/2007	IN	15.0	15		F	10/17/2007	Pain down (L) arm for several hrs after shot Fever 102-103 by touch 4 diffuse ache and headache 12 hrs after immunization				Y					Y	10/03/2007	10/04/2007	1		PVT	PVT	Trinessa					1						1	Headache; Pain; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U2448AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2824AA~7+~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0293992	10/22/2007	PA	22.0	22		F	10/16/2007	Tightness in chest, short of breath, dizzy, chills lightheaded, increasing itching at injection site Treatment-O2 at 6 L/min, Aqueous Epinephrine 1:1000, 0.3 cc SQ, Transported to ER in ambulance				Y					Y	10/16/2007	10/16/2007	0		OTH	PUB	Magnesium, Multivitamin, Zinc, Glucosamine, Yasmin, Reglan	None	Allergic to the sun, TB test	~Meningococcal (no brand name)~UN~18.00~In Patient		1						1	Chest discomfort; Chills; Dizziness; Dyspnoea; Injection site pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA053AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0293993	10/22/2007	PA	52.0	52		F	10/18/2007	SOB on evening of vaccine with palpitations. Red/exanthema, raised area at site c/o itching/pain/burning at site of injection.									Y	10/17/2007	10/17/2007	0	Had root canal done on 10/12/07 and was put on antibiotic	OTH	OTH	Pen VK 500mg QD	Had root canal done 10/12/07	Migraines, Hypothyroidism, Depression, Allergy: Dilantin; Metamucil			1						1	Dyspnoea; Erythema; Injection site irritation; Injection site pain; Injection site pruritus; Injection site swelling; Palpitations; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA030AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0293994	10/22/2007	NC	3.0	3		F	10/18/2007	Large area of erythema and induration surrounding shot outer-not tender				Y					U	10/16/2007	10/17/2007	1	None	PVT	PUB		None	None			1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U2446AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0293998	10/22/2007	WY	66.0	66		F	10/22/2007	a sore throat the next day and for two days sore throat and running nose.  next saturday hoarseness and slight shorness of breathing.  Today still slight hoarseness.									U	10/13/2007	10/14/2007	1		UNK	UNK		none	nnone			1						1	Dysphonia; Dyspnoea; Pharyngolaryngeal pain; Rhinorrhoea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua3058a~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0293999	10/22/2007	NY	70.0	73		F	10/22/2007	Patient developed redness, swelling and pain in left arm approximately 2 days after receiving vaccine.  Patient visited emergency room and was diagnosed with cellulitis.  Treated with Doxycycline.				Y					U	10/17/2007	10/19/2007	2	Unknown	PUB	PUB	Unknown	None	Unknown			1						1	Cellulitis; Injection site erythema; Injection site pain; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA2821A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0886F~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294000	10/22/2007	NY	61.0	61		F	10/22/2007	Received vaccine at approx 2:PM on 10-15-07, within 14 hours experienced excruciating, disabling, burning pain in legs and feet upon standing and  arms and hands when hanging at sides. Pain radiated down entire back of leg to bottom of foot and continued on to top of foot. Pain in arms and hands radiated down backs of arms and hands and produced numbness in wrists and hands. Walking, sitting and lying down produced minimal pain. Standing still produced pain of 10 on a scale of 1 to 10 resulting in loss of 3-1/2 days of work. Pain gradually subsided completely after 6 full days.				Y					Y	10/15/2007	10/16/2007	1		PVT	UNK	Sulpha for UTI; Lipitor 10 mg; Fosamax 70 mg	UTI	High cholesterol, oseteopenia, arthritis.	muscle pain, sniffles~Influenza (Seasonal) (no brand name)~NULL~60.20~In Patient		1						1	Burning sensation; Hypoaesthesia; Pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0294003	10/22/2007	VA	39.0	39		F	10/22/2007	Pt reported body aches and sore arm on Sat with egg size swelling, heat, redness to site on Sun and itching. Today swelling less but s/s persists. Denies n/v/d, dizziness, weakness, fever, sob, cp, or paresthesia. Did have episode of tunnel vision and weakness x 1 hr post vaccine attributed to fear of needles. Had white light in periphery as if going to faint, felt like was sweating ice, but not diaphoretic, no airway obstruct or distress, no dysphagia. Onset about 5 min post vac lasting 1 hour then resolved. Was alone in office.  Had never had reaction to vac/injection like this before.  Denied any anaphylactic reactions.  Works with newborns and is a nurse. Will come to HC for documentation purposes.  Has allergy to chicken feathers, down pillows, all feathers (tested as child by pediatrician- pt never had skin testing), cats, long haired dogs...eyes swell and can't breathe. Can eat eggs w/o problems.  Did note this felt like Versed reaction when BP dropped out 66/42, sweating, distant hearing.									Y	10/19/2007	10/20/2007	1		MIL	MIL	albuterol prn, Adderol for ADD	none	Asthma, ADD. HX FluMist administration in 2006 and gagged	none~ ()~~0.00~Patient		1						1	Asthenia; Dizziness; Fear; Injection site erythema; Injection site pruritus; Injection site swelling; Injection site warmth; Pain; Pain in extremity; Tunnel vision	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0294004	10/22/2007	CA	54.0	54		F	10/22/2007	Started experiencing pain in L knee day after vaccine (Thursday). By Friday AM could not hardly bend my L knee due to swelling and pain. (I have had no prior injuries or arthritis in my L knee.) Treated it with ibuprofen, ice and heat. Saturday AM my R knee felt just like my L knee did. Treated it the same way. The pain moved down into my calves on or about the 7th day. It has gotten better very slowly over the last 12 days, but still now back to normal.									Y	10/10/2007	10/11/2007	1	None	PUB	PUB	carbamazepine, gabapentin, simvastatin, atenolol, triamterene, valsartan, glipizide levothyroxine, oxybutinin, Ca+, Vit D, green tea extract, msm, chondroitin, glucosamine	None	diabetes, HTN, hypothyroidism, trigeminal neuralgia, hypercholesterolemia	none~ ()~NULL~~In Patient|none~ ()~NULL~~In Sibling1		1						1	Arthralgia; Joint swelling	FLU3~SANOFI PASTEUR~U2453AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294005	10/22/2007	PA	51.0	51		F	10/22/2007	10/11/2007 L deltoid / inferior humerus subcutaneous soft tissue erythema approx 2 cm oval distribution, induration. nontender  recommended benadryl 50 mg po q 6 hours / warm compresses. reevaluated 24 hours later 10 cm induration nontender , recheck 10/15/2007 completely resolved									Y	10/10/2007	10/11/2007	1	none	MIL	MIL						1						1	Erythema; Induration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~afla300aa~6~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0294007	10/22/2007	IN	35.0	35		F	10/22/2007	Very dizzy-off-balance, very itchy,sleepnesses.  Symptoms started on Saturday morning 10/13 and continued until Monday 10/15.									Y	10/12/2007	10/13/2007	1		UNK	UNK		NONE	Diabetic			1						1	Balance disorder; Dizziness; Pruritus; Somnolence	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78991~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0294008	10/22/2007	LA	44.0	44		F	10/22/2007	feverish, fatique, lymph node above left clavicle, muscle soreness of entire left shoulder and arm .  Instructed to use ibuprofen, heat and rest arm.  She will follow up daily for the next 3 days.				Y					U	10/19/2007	10/20/2007	1		UNK	UNK		none				1						1	Fatigue; Lymphadenopathy; Myalgia; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA296JA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0294009	10/22/2007	TX	64.0	64		F	10/22/2007	Sudden onset 6 hours after injection. Was feeling normal, and within minutes, severe feeling of vertigo, lightheaded and dizzy. Room seemed to spin as if I were intoxicated Needed to hold onto furniture to walk.  Could not walk straight, and could not focus on reading material. Slight headache.				Y					Y	10/21/2007	10/21/2007	0	Went to ER. They ran a cat scan of my head, complete blood profile, and EKG. All tests returned within normal ranges.	UNK	UNK		none	none	none~ ()~NULL~~In Patient		1						1	Blood test; Dizziness; Electrocardiogram normal; Gait disturbance; Headache; Scan brain; Vertigo; Visual disturbance	FLU3~SANOFI PASTEUR~49281-0380-15~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294010	10/22/2007	MI	38.0	38		F	10/22/2007	C/O tingling in lips and pain in arm.  per patient report - Went to urgent care did have fever at urgent care.  received Benedryl and Tylenol at urgent care per patient report.  3 days later patient states does not feel energetic.				Y					Y	10/12/2007	10/12/2007	0	pateint states allergic to bee sting and fish	PUB	PVT		none known				1						1	Allergy to arthropod sting; Food allergy; Pain in extremity; Paraesthesia oral; Pyrexia	FLU3~SANOFI PASTEUR~U2505AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294011	10/22/2007	GA	31.0	31		F	10/22/2007	Patient lost conciousness 5 minutes after vaccine was administered. She came around after 1 minute. She may have had a seizure. She rested, recovered and went home.									Y	10/18/2007	10/18/2007	0		UNK	PVT	fluoxetine Birth control	none	none			1						1	Convulsion; Immediate post-injection reaction; Loss of consciousness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua303ba~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0294014	10/22/2007	WV	4.0	4		F	10/22/2007	Developed bilateral joint pain in knees later in evening; large size of 21/2 X 2 1/2 area at injection site, red, raised warm to touch									Y	10/17/2007	10/17/2007	0	none	PUB	PUB	NOne	NO	No			1						1	Arthralgia; Injection site erythema; Injection site swelling; Injection site warmth	DTAP~SANOFI PASTEUR~U1986AA~5~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~203062~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0289U~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1333F~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0294015	10/22/2007	FL	17.0	17		F	10/22/2007	Client fainted for 5-10 seconds right as she rec'd the HPV vaccine. Had already had 2 injections and was vey anxious at that time. grandmother with her at that time was holing her hand and client face was covered. client came back to and c\o feeling dizzy with nausea.BP-80/50,P-52. 30 minutes later BP-110/74,P-70.called on 10/22/07 spoke with client and no other adverse reacion noted since injection									Y	10/19/2007	10/19/2007	0	none	PUB	PUB	none	none known	none			1						1	Anxiety; Blood pressure decreased; Dizziness; Heart rate; Nausea; Syncope	FLU3~GLAXOSMITHKLINE BIOLOGICALS~U2436AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|HPV4~MERCK & CO. INC.~0245U~1~IM~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2371AA~2~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0294017	10/22/2007	CA	33.0	33		M	10/22/2007	Wheezing , unable to breath, coughing									Y	10/10/2007	10/10/2007	0	I have taken the vacine at my work place so not sure about the manufacture and lot number.I was administered a injection.	UNK	UNK		none	none			1						1	Cough; Dyspnoea; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0294019	10/22/2007	CO	44.0	44		F	10/22/2007	Diarrhea, vomiting, and fever.  Has continued throughout the day.  Lower back pain.									N	10/20/2007	10/22/2007	2		PUB	PVT	Lexapro					1						1	Back pain; Diarrhoea; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0294020	10/22/2007	MI	79.0	79		F	10/22/2007	Presented to ER the day after receiving the flu vaccine.  C/O lethargy, SOB.  Pt with temp of 100.8 degrees F.  Pt having slurred speech, twitching and decreased lung sounds throughout.    Pt reported allergies include sulfa, contrast, theophylline, ACE inhibitors, NSAIDs and iodine.				Y					N	10/19/2007	10/20/2007	1	Chest X-ray	UNK	UNK						1						1	Body temperature increased; Breath sounds abnormal; Chest X-ray; Dysarthria; Dyspnoea; Lethargy; Muscle twitching	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294023	10/22/2007	OH	63.0	63		F	10/22/2007	Swelling upper left arm, erythema, extreme soreness- 3 hrs. post injection. Shortness of breath and nausea.				Y					Y	10/20/2007	10/20/2007	0		UNK	UNK	Lipitor	None	Sulfur, Lung collapse (4-30-07)			1						1	Dyspnoea; Erythema; Nausea; Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~U2469AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0993U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294024	10/22/2007	AL	0.8	0	.8	M	10/22/2007	Patient developed rash approximately 1 hour after administration of the flu shot. Rash itchy, welps. Resolved after benadryl administration at the emergency department at Hospital.				Y					Y	10/15/2007	10/15/2007	0		UNK	UNK		None	Asthma, umbilical hernia		AL0710	1						1	Rash pruritic; Urticaria	FLU3~SANOFI PASTEUR~UT2456GA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294025	10/22/2007	AL	4.0	4		M	10/22/2007	Developed redness and swelling to right upper thigh 24 hours after shots.  Seen at Hospital ER 10/7/07 and placed on Keflex and Bendadryl for cellulitis.  Had follow up visit with primary doctor 10/9/2007-almost back to normal.				Y					Y	10/05/2007	10/06/2007	1		UNK	UNK		None	eczema, speech problems		AL0711	1						1	Cellulitis; Injection site erythema; Injection site swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14BO49AA~5~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2487AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB200AA~1~IM~RL~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~Z0873~UNK~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1324F~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0781U~UNK~IM~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0294026	10/22/2007	CA	55.0	55		F	10/22/2007	Superficial infection Left deltoid within 2-3 days and lasting 4-5 days.  Generalized malais, joint tenderness, body aches, ad weakness since vaccination.  Right shoulder severe pain, mild warmth and decreased range of motion from 10/16/07 and continued through this reporting date.									U	10/01/2007	10/01/2007	0	None	MIL	PVT		None	None known			1						1	Arthralgia; Asthenia; Injection site infection; Joint range of motion decreased; Malaise; Musculoskeletal pain; Pain; Skin warm	FLU3~SANOFI PASTEUR~U2441AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294028	10/22/2007	MI	59.0	59		F	10/22/2007	ABOUT 2:30 A.M.WOKE UP WITH A ON AND OFF AGAIN HEADACHE THAT STARTED ABOVE MY RIGHT EYE AND TRAVELED TO MY RIGHT EAR. I GOT UP AND HAD SOME WATER BUT THE HEADACHE KEPT GETTING WORSE. GOT UP AGAIN ABOUT 3:30 AND TOOK TWO ASPIRIN, ABOUT 4:00 A.M. GOT UP AND HAD DIARRHEA, WENT BACK TO BED ABOUT 4:30 GOT BACK UP AND VOMITED ALL THE WATER AND ASPIRIN UP.  THE HEADACHE GOT A LITTLE BETTER BUT ALL DAY IT WAS THERE AND I FELT DEHYDRATED AND JUST SICK.  COULDN`T DRINK ANYTHING OR EAT. I SLEPT ALL DAY, ABOUT 6;00 P.M. I STARTED TO FEEL A LITTLE BETTER. I DON`T THINK I`LL GET ANOTHER FLU SHOT NEXT YEAR, I HAVE NEVER HAD A HEADACHE LIKE THAT BEFORE									Y	10/20/2007	10/21/2007	1		UNK	UNK	NONE	NO	NONE			1						1	Dehydration; Diarrhoea; Headache; Malaise; Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0294029	10/22/2007	WA	55.0	55		M	10/22/2007	Injection at 9 am . By 2pm experienced stomach/intestinal cramps, headache and leg muscle pain.  Saturday morning got up at 7 am with severe stomach/intestinal cramps, headache and leg muscle pain.  Took ibuprofin and vicodin to relieve symptoms. Felt bad all day. Sunday morning woke up at 4 am with same symptoms. Same ibuprofin/vicodin pain relief. Felt bad all day. Moday morning woke up midnite, 2am, 4am with severe headache. At 2am had severe abdominal pain. Same ibuprofin/vicodin pain relief. Still hurt at 4pm Monday.									U	10/19/2007	10/19/2007	0		PVT	PVT	wellbutrin, effexor, vicodin	lymphoma	lymphoma			1						1	Abdominal pain; Abdominal pain upper; Feeling abnormal; Headache; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0294035	10/22/2007	IA	9.0			F	10/10/2007	A serious report of anosmia has been received from a physician concerning a nine-year-old female. No relevant medical or drug history information has been reported for this patient. The patient received the initial dose of FluMist on an unknown date in 2005 and continued to receive FluMist on unknown dates in 2006 and 2007. On an unknown date in the summer of 2005, the patient began complaining of not being able to smell anything. Reporter was not sure whether this occurred before or after receiving the initial dose of FluMist. The patient continued to complain of not being able to smell, but continued to receive FluMist in 2006 and 2007. A neurologist was consulted and a MRI was performed in Sep 2007 with normal results. A smell test was also performed in Sep 2007 and the results were abnormal. In Oct 2007, the patient's primary care provider called the sponsor's medical information department to ask if anyone had lost the ability to smell after receiving FluMist. While obtaining follow up information, the primary care physician stated the smell test indicated that the child could not smell anything and that she was not sure when a child recognizes the sense of smell or the absence of the sense and was not sure whether the loss of smell could be a result of a virus or was present at birth. The primary care physician would not release the contact information for the neurologist. The event has not resolved and is considered to be a permanent disability by the primary care provider. No additional information information is available. The primary care physician was unsure whether the patient would continue to receive FluMist. The patient did not experience a rechallenge while receiving the suspect product. The reporter did not provide a causality assessment for the adverse events reported.								Y	N				MRI 09/??/07 Normal, Smell Test 09/??/07 Abnormal	PVT	PVT	Concomitant Drug(s) Not Reported				MEDI0006011	1						1	Anosmia; Laboratory test abnormal; Nuclear magnetic resonance imaging normal	FLUN3~MEDIMMUNE VACCINES, INC.~~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Disabling	Influenza
0294037	10/22/2007	MI	65.0	65		M	10/22/2007	Flu vaccine was given at the clinic. Patient states approximately 5 hours after getting the flu shot his eyes got very red, itchy and swollen. The patient did notify the clinic where the injection was given and the doctor's office.									U	10/17/2007	10/17/2007	0		UNK	UNK						1						1	Eye pruritus; Eye swelling; Ocular hyperaemia	FLU3~SANOFI PASTEUR~u2465aa~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294038	10/22/2007	MI	51.0	51		F	10/19/2007	Flu vaccine was given at the clinic. Pt states approx 5 hours after getting the flu shot her eyes got very red, itchy and swollen. Pt notified the clinic where injection was given and the doctor's office.									U	10/17/2007	10/17/2007	0		UNK	UNK						1						1	Eye pruritus; Eye swelling; Ocular hyperaemia	FLU3~SANOFI PASTEUR~U2465AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294039	10/22/2007	DC	5.0	5		F	10/15/2007	Received vaccines: Hep A #1, Varicella #2, Influenza at 5 year check and within 12 hours developed fever to 102.3 despite Tylenol and had febrile seizure (1st febrile seizure). Was evaluated in ER and released. Seizure believed to be <5 minutes in length.				Y					Y	10/11/2007	10/11/2007	0		PUB	PUB		None	Mild intermittent asthma			1						1	Febrile convulsion; Pyrexia	FLU3~SANOFI PASTEUR~U2461AA~2~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAV2218AA~1~UN~LA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1247~2~UN~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0294040	10/22/2007	IN	12.0	12		M	10/18/2007	erythema at site of injection-Right arm. Treated with Benadryl									Y	10/16/2007	10/17/2007	1	None	PVT	PVT		None	Obesity			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U2458EA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2392BA~1~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~1101U~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0294041	10/22/2007	SC	64.0	64		M	10/22/2007	4 hours after vaccine, pt c/o throat swelling, trouble swallowing, dyspnea, sudden head congestion - took Ibuprofen and came back to doctor 10-18-07.				Y					Y	10/17/2007	10/17/2007	0		PVT	PVT		None				1						1	Dysphagia; Dyspnoea; Pharyngeal oedema; Sinus congestion	FLU3~SANOFI PASTEUR~U2446AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294043	10/22/2007	MN	25.0	25		F	10/22/2007	Vaccine 10:30 a.m. on 10/17/07 Could hardly wake up on morning on 10/18/07. It was like I took a sleeping pill, and I had a strange headache. felt hot and cold. (Did not take temperature.) Dizzy on 10/19/07 and stayed home from work. 10/22 at work and feels fine.									Y	10/17/2007	10/18/2007	1		PVT	PVT		None	Allergy to Amoxicillin, Penicillin, Avelox, benzoin			1						1	Depressed level of consciousness; Dizziness; Feeling of body temperature change; Headache	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78749~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0294050	10/22/2007	MN	11.0	11		M	10/22/2007	Patient fainted, diaphoretic, pale, lethargic following commands A & O x c. Gave fluids PO, had pt put his head between knees. HR 70s-80s. Reg rate unsuccessful getting BP reading d/t small of arm. Pt continued to pass out then had came to. 911 was called and they found vitals were stable and encouraged pt rest at home.									Y	10/20/2007	10/20/2007	0	None	OTH	PVT	Unknown	No	Not aware of any			1						1	Hyperhidrosis; Lethargy; Loss of consciousness; Pallor; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80681~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0294051	10/22/2007	MN	49.0	49		F	10/22/2007	Patient received flu vaccination at 4:00 pm. Around 6:30 pm she experienced dry cough, itchy throat and eyes; this became progressively worse; her tong and throat started swelling up. Family called 911, patient taken to hospital. Condition stabilized in the E.R., by 10 pm. Pt discharged home by 11 pm. Pt seen by private MD for follow-up on 10/18. Recovery complete.				Y					Y	10/13/2007	10/13/2007	0	E.R. - MD diagnosed this event as an anaphylactoid event.	PUB	PVT	None	None	None			1						1	Anaphylactoid reaction; Cough; Eye pruritus; Pharyngeal oedema; Swollen tongue; Throat irritation	FLU3~SANOFI PASTEUR~U2466AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294054	10/22/2007	MN	64.0	64		F	10/15/2007	fever shakes sore arm-RED area by injection site Resolved in about 7 days per client on 10/22/07									N	10/13/2007	10/13/2007	0		UNK	UNK		None	None			1						1	Injection site erythema; Pain in extremity; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U2466AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294055	10/22/2007	TX	20.0	20		M	10/22/2007	That evening, patient's arm started to swell around injection site and was red and warm to touch. Patient felt bad and had fever and chills. Patient went to an emergent care clinic where he was treated with antibiotics prophylactically to rule out infection. The site of reaction was on the right arm. Patient was also seen by primary care provider and believed to be AE to pneumonia vaccine.				Y					U	10/20/2007	10/20/2007	0		OTH	OTH			Cochlear implant 10 yrs ago			1						1	Chills; Feeling abnormal; Injection site erythema; Injection site swelling; Injection site warmth; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA294EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|MEN~SANOFI PASTEUR~UF078AA~1~SC~LA~MENINGOCOCCAL (MENOMUNE)~1|PPV~MERCK & CO. INC.~1035F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294057	10/22/2007	NM	70.0	70		M	10/22/2007	Left arm swollen stopping at elbow with pain; treated with Ibuprofen 600 mg x qd and Vicodin									U	10/17/2007	10/18/2007	1		PVT	PVT	Lisinopril/HCTZ	None	Hypertension			1						1	Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2458EA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0859U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294060	10/22/2007	MN	18.0	18		F	10/22/2007	Whole body reaction - flushed skin, hot flashes - pruritis - tried with Zyrtec.				Y					Y	10/16/2007	10/17/2007	1		PVT	PVT		None				1						1	Flushing; Hot flush; Pruritus	FLUN3~MEDIMMUNE VACCINES, INC.~500487P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~1265U~1~IM~LA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0294061	10/22/2007	MN	56.0	56		M	10/22/2007	None as of date of infection.										10/22/2007				PVT	PUB						1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2452AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B013AA~UNK~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0185174	10/23/2007	TX	48.0	48		F	10/17/2007	Vaccine - zoster given 10/5/07 no ordered and requested by patient she was here for annual physical and flu vaccine too. 10/11 came back in with rash looking like shingles				Y					Y	10/02/2007	10/10/2007	8	Culture of blister content - negative	PVT	OTH	LEXAPRO; HCTZ; LISINOPRIL; NEUROTIN; VALTREX; PRILOSEC; PROTONIX	None	HTN; asthma; GERD; Osteoarthritis; TMJ; Migraines; Seasonal allergies	rash~Varicella (Varivax)~UN~0.00~In Patient		1						4	Culture negative; Herpes zoster; Inappropriate schedule of drug administration; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79718~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~4|TDAP~SANOFI PASTEUR~C2775AA~2~UN~LA~TDAP (ADACEL)~4|VARZOS~MERCK & CO. INC.~0619U~1~UN~RA~ZOSTER LIVE (ZOSTAVAX)~4	USA	Emergency room visit	Influenza
0292910	10/23/2007	OR	40.0	40		F	10/23/2007	Hive like rash all over, fever to 101.8 with headaches, myalgias, marked pain and swelling at injection site (L) arm with erythema and warmth.									Y	10/08/2007	10/09/2007	1	ESR 27; WBC 15.3; Normal metabolic panel	UNK	OTH	Altace, Metoprolol, Clonazepam, Ambien, Omeprazole	None	All: Doxycycline, Codeine			1						2	Body temperature increased; Fatigue; Headache; Influenza like illness; Injection site pain; Injection site swelling; Lethargy; Rash; Erythema; Headache; Injection site pain; Injection site swelling; Laboratory test normal; Myalgia; Pyrexia; Rash; Red blood cell sedimentation rate increased; Skin warm; Urticaria; White blood cell count increased	FLU3~SANOFI PASTEUR~U2888AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0962U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U2488AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0962U~1~UN~LA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0294033	10/23/2007	OK	21.0	21		F	10/23/2007	Began itching within 10 minutes. Flu and pneumonia shots given in same arm. Red that evening. Next morning very swollen. By second morning a swollen red area 6 1/2 x 3 raised, red and very swollen. Dr. said reaction had to be treated like a staph infection. Dr. gave decadron and antibiotic for 10 days. When medication gone, still slightly red, itchy, and sore after 16 days				Y					U	10/06/2007	10/06/2007	0	Dr. told us on 10/22/07 that two other patients had come in with the same reaction to vaccinations from the same location. Patient was the first one.	UNK	UNK	trazodone	none	allergy to mango			1						1	Erythema; Pain; Pruritus; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80684~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0958F~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294106	10/23/2007	MI	68.0	68		F	10/23/2007	Patient presented a new rx for Prednisone on 10/21/07 and asked if I remembered giving her a flu shot on 10/17/07. She said the day after the shot she had bruising and tenderness at the site of injection. Two days after the shot the bruising worsened and the entire left arm was red. She was experiencing shortness of breath, light headness, and elevated blood pressure (178/91). Upon the urging of her daughter she went to the hospital ER on 7/19/07. The medical staff told her that I had hit a vein during the injection. She stayed in the hospital overnite and was treated with IV steroids.  11/09/2007 MR received for ER visit 10/19-20/2007 for c/o lightheadedness, nausea, and SOB and L arm pain.  Pt had been experiencing nausea r/t nerves, weakness, SOB-taking increased nebs, and cough x 1 week.  Per pt sx worsened following flu shot.  BP noted to be elevated in ER.  Cardiac consult with impression: Nausea, SOB, lightheadedness. R/O 2' to HTN vs influenza vaccine reaction. CAD with previous angioplasty x2.  Cardiac status is stable and pt ok for D/C				Y	Y	1			Y	10/17/2007	10/18/2007	1	Labs and Diagnostics: EKG WNL. CXR (+) for hyperinflation and flattening of the diaphragm suggestive of COPD.  Troponin 1 (-)x3.  Otherwise unremarkable.	OTH	OTH	ZOLFIDEM 10mg; PLAVIX 75mg; TRAMADOL 50mg; LISINOPRIL 20mg; ALBUTEROL MDI; CERTRALINE 50mg; LOMOTIL		PMH:  HTN, CAD, COPD, bladder CA, depression, thyroid, MI x2, AAA, smoker. Allergies: Wellbutrin. PCN.			1						1	Blood pressure increased; Dizziness; Dyspnoea; Erythema; Incorrect route of drug administration; Injection site bruising; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA294EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0294107	10/23/2007	WI	54.0	54		F	10/17/2007	Evening of 10-16-07 noticed blotchy, fine red rash on legs. Eventually spread to torso and arms. Took Benadryl. This morning rash still present, mild itchiness, did not take anymore Benadryl. No SOB, chest pains or other systemic sx. Referred to PMD for evaluation ~ has appointment this afternoon.				Y					Y	10/15/2007	10/16/2007	1		PUB	PVT	SYNTHROID DAILY; LAMISIL 250mg DAILY (began 3 weeks ago); CHANTIX 1mg daily (begin July)	None	HYPOTHYROIDISM; ERYTHROMYCIN (upsets stomach)			1						1	Pruritus; Rash macular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81108~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0294110	10/23/2007	OH	46.0	46		M	10/18/2007	Extreme dizziness, weakness, disorientation, ringing in ears - for 3 days - no treatment.									Y	10/08/2007	10/08/2007	0		OTH	PVT	vitamins and Green Tea	Little cold	Hayfever			1						1	Asthenia; Disorientation; Dizziness; Tinnitus	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0294111	10/23/2007	CO	4.0	4		F	10/18/2007	Large local reaction following vaccination erythema and swelling - 50mm x 30mm (3 x 5 cm) itchy									Y	10/16/2007	10/16/2007	0	None	PUB	PUB	None	None	None			1						1	Erythema; Local reaction; Pruritus; Swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC148036BA~5~UN~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2490AA~3~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0018~4~UN~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0861F~2~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~10059~2~UN~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0294113	10/23/2007	CA	67.0	67		F	10/16/2007	After over one hr of getting the flu shot, patient came back and claimed that her face turned purplish pink and her face seemed swollen. She appeared to be lightly shortness of breath. Her BP reading were around 200/100 with HR of 80. She took 2 puffs of Albuterol. One more hour later, she was taken to hospital by paramedics without any worsen symptoms.				Y					U	10/16/2007	10/16/2007	0		OTH	OTH	PROVENTIL; PREDNISONE; LIPITOR; LASIX; LEVOXYL		Penicillin allergy			1						1	Blood pressure increased; Dyspnoea; Heart rate increased; Skin discolouration; Swelling face	FLU3~SANOFI PASTEUR~U2523AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294115	10/23/2007	CO	4.0	4		M	10/19/2007	3 days after vaccines rash started, mildly itchy. 10/11/07 skin started peeling on lower abdomen and arm pit. Abx started. Strep test was performed negative results.				Y					U	10/03/2007	10/06/2007	3	Strep test to r/o strep but as negative	PVT	PVT	None	None	None			1						1	Rash pruritic; Skin exfoliation; Streptococcal identification test negative	FLU3~SANOFI PASTEUR~U2441AA~3~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0304U~2~IM~UN~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~1271U~2~SC~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0294119	10/23/2007	NM	16.0	16		F	10/17/2007	Swelling at injection site (Pneumonia shot site), rash at injection site, arm soreness, joint pain, headache, neck pain, hip and lower back pain only low grade fever, sore throat.				Y					N	10/15/2007	10/16/2007	1	None - no tests performed	PUB	PVT	Oral contraceptives		None - allergic to walnuts (tree nuts)			1						1	Arthralgia; Back pain; Headache; Injection site rash; Injection site swelling; Neck pain; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U2509AA~4~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~U962U~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294121	10/23/2007	MN	68.0	68		F	10/18/2007	Sudden onset chills/ fever, muscle aches, extreme fatigue - lasted 12-14 hours - still fatigue and sore throat at 72 hours.									Y	10/15/2007	10/16/2007	1	Non	PVT	PVT	LASIX; POTASSIUM; ALTACE; ULTRACET; COUMADIN; CORG	None	dermatomyositis; Pulmonary embolism history; history brica; has defibrillator			1						1	Chills; Fatigue; Myalgia; Pharyngolaryngeal pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA300AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0294123	10/23/2007	CA	47.0	48		F	10/19/2007	Body weak almost 1 hour after the flu shot, there was no strength, pressure in my head, then my throat felt dry and raspy, body weak. Then I started sneezing a lot, and my nose was runny. 6 days later now, and I still feel sick. I felt good before the shot.									N	10/13/2007	10/13/2007	0	October 13, 2007 approx. 5:10 PM	PVT	OTH		Weak body; dry throat; head pressure; sneeze	Allergic to Penicillin			1						1	Asthenia; Dry throat; Headache; Malaise; Rhinorrhoea; Sneezing	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0294124	10/23/2007	OH	9.0	9		M	10/18/2007	Mild erythema no raised borders non tender to palpation on left arm (Varivax given at this site).				Y					Y	10/10/2007	10/13/2007	3		PVT	PVT			Allergic to PCN; Omnicef			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U2448AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1274U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0294125	10/23/2007	IL	35.0	35		M	10/18/2007	10-17-07 Client received flu vaccine at 900 a.m. and started having swelling and redness and chills (did not take temp). Back of neck was hot. Had redness on abdomen and legs. Took 1 cap Benadryl. Redness and swelling were approx 1-2m above right elbow. 10/18/07 redness and swelling reported. 10/18/07 no chills.									U	10/17/2007	10/17/2007	0		OTH	PVT		None				1						1	Chills; Erythema; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~99897~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0294128	10/23/2007	OH	66.0	66		F	10/18/2007	Left arm swelled shoulder to elbow, got red, hot, no itching. Face and chest got red and hot.				Y					Y	10/15/2007			None	PVT	PUB		None	Allergies: Quinolones and Bactrim			1						1	Erythema; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U2465AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0554U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294129	10/23/2007	OH	71.0	71		M	10/18/2007	Increase in gout symptoms: pain, tenderness, warmth in feet and knees.									Y	10/15/2007	10/15/2007	0	None	PVT	PUB		None	None			1						1	Condition aggravated; Gout; Pain; Skin warm; Tenderness	FLU3~SANOFI PASTEUR~U2465AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0554U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294130	10/23/2007	OH	16.0	16		F	10/15/2007	Fever to 102F beginning within 8 hours of immunization and large local reaction about 20cm x 20cm distal to site of injection beginning 1 day of shots. Increased temperature persisted x 3 days. Was treated with Bactrim on 10/14/07.				Y					U	10/11/2007	10/11/2007	0	None	PVT	PVT	Yaz; Amoxicillin	Nasal congestion, probably allergy	Asthma, Orthostatic hypotension, Angioedema, Alopecia			1						1	Body temperature increased; Local reaction; Pyrexia	FLU3~SANOFI PASTEUR~U2469AN~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0200U~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294131	10/23/2007	TX	72.0			F	09/25/2007	Hives - started 12 hours after vaccines. Started on Benadryl then Zyrtec and Zaretia 24 hours later.									Y	09/24/2007	09/24/2007	0	None	PVT	PVT		None	PCN; CIPRO; HTN			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2442AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0962U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294132	10/23/2007	OH	48.0	48		M	10/16/2007	Dizziness, shaking in extremities approximately 2 hours after inoculation. 25mg Benadryl given orally 2.5 hours after inoculation.										10/16/2007	10/16/2007	0		PVT	OTH		CHF; Flush pulm. edema	asthma; COPD; CHF; Smoker; Umbilical hernia			1						1	Dizziness; Tremor	FLU3~SANOFI PASTEUR~U2440AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0804U~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294133	10/23/2007	MD	60.0	60		M	10/23/2007	Fever, throbbing headache - both lasting about 2.5 days.  Treatment was rest and tylenol									Y	10/18/2007	10/19/2007	1		UNK	PUB	Verapamil SR, Inder LA, hydrochlorothiazide, lisinopril, arthrotec, byetta, omacor, glipizide, avandamet, niaspan ER, lipitor, vitamin C, co-Q 10, glucosamine-chondrotin, multipurpose vitamin, baby aspirn, claritan (as needed)	None	Diabetes, hypertension, high triglycerides, weight issues			1						1	Headache; Pyrexia	FLUX~UNKNOWN MANUFACTURER~Unknown~7+~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0294134	10/23/2007	AL	34.0	34		M	10/23/2007	Patient was exposed to employee who was diagnosed with the shingles prior to receiving the Flumist. Physician suspects the Flumist decreased the patient's immune response enough to have an outbreak of the shingles. He was diagnosed with Herpes Zoster on 21 October 2007. He was treated at a local Emergency Room, given Zovirax for treatment and placed on quarters for 72 hours.				Y					Y	10/10/2007	10/21/2007	11		MIL	MIL			Nephrolithiasis			1						1	Herpes zoster	FLUN3~MEDIMMUNE VACCINES, INC.~500485P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0294135	10/23/2007	FL	61.0	61		M	10/23/2007	PLEASE NOTE.  I AM THE PATIENT'S WIFE REPORTING THIS.  I DO NOT KNOW THE MANUFACTURER SO I JUST CHOSE ONE IN ORDER TO BE ABLE TO SUBMIT THIS REPORT.  This facility administered a 3rd PPV despite us telling them that we had previous ones in 2002, and 1997.  We were unable to read the PPV sheet as by the time it was given to us and the time we entered to have the vaccine, there was not enough time for us to thoroughly read and understand the sheet. Within 15 hours after vaccination, patient became very sick running a temperature of 100.2 to 101.8 for the next 72 hours with rigors and severe headache, along with aching and malaise all over.  Fever subsided finally, but administration site is still swollen, tender, and red.									U	10/19/2007	10/20/2007	1		UNK	UNK	Not applicable.	None.	Not applicable.	None~Pneumo (no brand name)~2~0.00~Patient		1						1	Body temperature increased; Chills; Headache; Injection site erythema; Injection site pain; Injection site swelling; Malaise; Pain	FLU3~CSL LIMITED~X00000000000~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~X00000000000~4~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294136	10/23/2007	FL	60.0			F	10/23/2007	I AM THE PATIENT FILLING OUT THIS FORM AND I JUST CHOSE ANY MANUFACTURER AS I DO NOT KNOW IN ORDER TO BE ABLE TO COMPLETE FORM AND SUBMIT.  THE ISSUE HERE IS THAT THE FACILITY IS UNEDUCATED ON THE NUMBER OF PPV VACCINATIONS A PERSON SHOULD RECEIVED!  Approximately 12 hours after receiving a 3rd PPV vaccination (previously received in 1997, 2002) my left arm where the vaccine was administered blew up to twice its normal size with extreme localized pain.  24 hours after that, the area was bright red and the redness continued to progress in a band across the deltoid area of my upper arm where the vaccine site was.  It was extremely painful as well.  My axillary lymph node and left breast were also painful.  It is still slightly red and painful almost 4 days later.  We were given a PPV sheet to read, however were called in to have the vaccine given, and we told them it was our 3rd shot, before we had time to fully read and understand the sheet.  This walk-in clinic needs much education on the PPV vaccine and should not be giving out without fully understanding it themselves.									N					PVT	PVT	Not applicable.	None.	None.	None.~ ()~NULL~~In Patient		1						1	Injection site erythema; Oedema peripheral; Pain; Pain in extremity	FLU3~CSL LIMITED~X0000000~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~X0000000~3~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294137	10/23/2007	NY	53.0	53		F	10/22/2007	Received TIV vaccine at 11:30 am.Thurs 10/18/07. Achey by mid afternoon. Shaking chills and fever of 102 (orally) by 5 pm. Vomiting by 5:30 pm.(vomited X2)  In bed that evening and all day Friday. Temp of 101 by mouth (with acetaphminophen, 700mg every 4-6 hours) for next 48 hrs. Recovered slowly on Saturday. Well by Sunday.									Y	10/18/2007	10/18/2007	0	none	PUB	PUB	Lopid 600 mg. once a day,    Vitamin B12 once a day,  Folic Acid once a day,  Calcium once a day,  Fosamax once a month	No	None			1						1	Chills; Pain; Pyrexia; Tremor; Vomiting	FLU3~SANOFI PASTEUR~U2478BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294138	10/23/2007	SC	49.0	49		F	10/23/2007	I developed respiratory symptoms within 48 hours (starting the evening of 10/18/2007)of receiving the vaccine.  I am now on my 5th day of cold-like viral symptoms; e.g. coughing spasms, malaise, nasal congestion, headache, and achy feeling.  I still have these symptoms presently.									U	10/17/2007	10/18/2007	1		UNK	PVT	Zovia (BCP)	None.  I have not been sick in years.	Septra, Celebrex, Cefzil, Minocin			1						1	Cough; Drug hypersensitivity; Headache; Malaise; Nasal congestion; Nasopharyngitis; Pain; Respiratory disorder	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80435~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0294146	10/23/2007	CA	93.0	93		M	10/23/2007	1 day after injection sxs of weakness, nausea, fever 101 F and erythema, warmth, tenderness over injection site of Pneumovax. Subsequently hospitalized for fever, possible lung infiltrate. 11/29/07-records received for DOS 10/20-10/23/07-DC DX: Pneumonia. Anemia. Received 2 units packed red blood cells. Presented with acute on chronic weakness and decreased exercise tolerance over a week prior to admission. Fever. Leukocytosis.  Seen in follow-up on 10/25/07-C/O fatigue, cough. Left arm swelling since vaccination.				Y	Y	3			Y	10/19/2007	10/20/2007	1	11/29/07-records received-CXR left lower lobe consolidation. Hemoglobin 8.6.	PVT	PUB	METOPROLOL; PREVACHOL; ASA; VIT B12	None	No known drug allergies; A-fibrillation; HTN; CAD; aortic stenosis, Anemia 11/29/07-records received-PMX: Chronic atrial fibrillation. Aortic steosis. Coronary artery disease. Hypertension. Myelodysplastic syndrome and related macrocytic anemia with red blood cell transfusion dependence.			1						1	Asthenia; Injection site erythema; Injection site pain; Injection site warmth; Nausea; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA310AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0555U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0294147	10/23/2007	PA	2.0	2	.1	M	10/23/2007	Received vaccine 10/20/07 in AM. Approx 8 hours later child experienced a generalized seizure for which he received benzodiazprim therapy and was hospitalized for observation and EEG.  12/04/2007 MR received for DOS 10/20-21/2007 with D/C DX: Seizure. While driving in the car, mother noted child vomited, then was having a tic with eye deviation to the L. Child was not responding, and was still seizing upon arrival to the ED. Seizure lasted ~ 10-15 min. ER MD noted generalized seizure activity with incontinence. PE (+) for somnolence, L TM erythema, mild L ant lymphadenopathy, mild rhonchi in LLL, tachycardia. Observed o/n and D/cd the next day.				Y	Y	1			Y	10/20/2007	10/20/2007	0	EEG. Labs and Diagnostics:  EEG 10/21/07: mildly abnormal-R temporal sharply contoured slowing. EEG 11/13/07 unremarkable.  Head CT (-). CBC unremarkable.	PVT	PVT		None	None. PMH: Rotavirus-hospitalized for dehydration.  NKDA.			1						1	Convulsion	FLU3~SANOFI PASTEUR~UT2474CA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0294148	10/23/2007	OR	20.0	20		F	10/23/2007	Within hours after vaccine, onset of diffuse pain and aching in both arms and shoulders which has persisted for several days. No specific tenderness at injection site. Pt has had flu vaccine without incident in the past. Pt had vaccine at a local store, not at our clinic.				Y					U	10/20/2007	10/20/2007	0		UNK	PVT	None	None	None			1						1	Musculoskeletal pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0294149	10/23/2007	IN	68.0	68		F	10/23/2007	After about 1 1/2 or 2  hours, eyes were sensitive to light and burned, watered.  Put on sun glasses for releif. Then after another hour  my throat felt tight and I would cough to clear throat.  Soon after I felt feverish and all my joints ached and my head was pounding. My body felt like it was in a vice. I had the chills also.  I took a Benadryl capsal and went to bed. Had the fever through the night and did not sleep well. The next day, my eyes were stuck closed,I was very weak, joints & muscles ached, still had a headache. No energy at all. Still had the throad tightening feeling. Cleaned my eyes open and the whites were very red. Cleared them with Visine for Allergys. Took another Benadryl. This went on all day. The next day the symptoms were very slight. By the following day, I was back to normal.									Y	10/18/2007	10/18/2007	0	None	UNK	UNK	None	None	None			1						1	Arthralgia; Asthenia; Chills; Cough; Eye burns; Headache; Lacrimation increased; Myalgia; Ocular hyperaemia; Photophobia; Pyrexia; Sleep disorder; Throat tightness	FLU3~SANOFI PASTEUR~U25 10AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294150	10/23/2007	NJ	34.0	34		F	10/23/2007	immediately after the vaccination: dizziness, fast herat beat, short of breath, weakness, stiff neck  -couple hrs later: weakness, slightly feverish									Y	10/22/2007	10/22/2007	0	not sure about the manufacturer of the Influenza. please check with the health services	UNK	UNK	None	none	None			1						1	Asthenia; Dizziness; Dyspnoea; Heart rate increased; Musculoskeletal stiffness; Pyrexia	FLU3~CSL LIMITED~~UNK~~~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0294153	10/23/2007	WI	39.0	39		F	10/23/2007	numbness in upper lip and lower nose									U	10/23/2007	10/23/2007	0	none	UNK	UNK	Wellbutrin	none	Penicillin, seasonal			1						1	Hypoaesthesia facial	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA302BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0294155	10/23/2007	ID	34.0	34		F	10/23/2007	Left arm neuropathy.  Patient has pain and decreased strength in left arm.  Pain and weakness started immediately after injection.  Patient is now having pain into her neck and down her left arm.				Y					N	10/11/2007	10/11/2007	0	Patient referred to Dr. (neurologist) for evaluation of brachial plexus neuralgia.	UNK	UNK	Synthroid 0.25mg qday, phentermine, albuterol inhaler prn	none	none			1						1	Asthenia; Neck pain; Neuropathy; Pain in extremity	FLU3~SANOFI PASTEUR~U2436AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294156	10/23/2007	NE	5.0	5		M	10/23/2007	Patient had a very high fever of 105 degree F 2 days after the vaccination and went to ER. The next day 3/4th of his rt arm (Pneumovax Vaccine arm)was red swollen and slightly painfull from just below the injection site				Y					U	10/18/2007	10/20/2007	2		PVT	PVT	Zyrtec 1 tsp daily and Rhinocort aqua 1 spray to each nose daily	None	Allergy test positive for grass, mould trees, dog. Patient also has asthma and history of multiple upper respiratory ilnesses with high fever			1						1	Erythema; Oedema peripheral; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U2461DA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0038U~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294157	10/23/2007	WA	22.0	22		M	10/23/2007	the patient had a folliculitis type rash, beginning about 17 Oct, day 12 after inoculation- Eruption occurred on back and chest, spreading over several days then resolving w/ recovery. NO systemic symptoms, supportive treatment provided.				Y					Y	10/04/2007	10/17/2007	13	Swab was PCR negative for vaccinia	MIL	MIL	NONE	Unknown	NONE			1						1	Folliculitis; Polymerase chain reaction; Rash	ANTH~MICHIGAN DEPT PUB HLTH~FAV110~2~UN~UN~ANTHRAX (NO BRAND NAME)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500483P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~PFIZER\WYETH~4020076~1~ID~UN~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0294158	10/23/2007	ME	0.75	0	.8	F	10/23/2007	Increase in seizures (baseline seizure disorder), partial seizures lasting 3 hours, spontaneously resolved.				Y					Y	10/22/2007	10/23/2007	1	glucose nl	PVT	PUB	zantac, prevacid, phenobarbital, vigabatrin	No	Absent corpus callosum, infantile spasms, GERD			1						1	Blood glucose normal; Convulsion	FLU3~SANOFI PASTEUR~UT2460FA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294166	10/23/2007	AL	67.0	67		F	10/23/2007	Approximately 3 days after receiving the vaccination pt began feeling achy with muscle stiffness.  She also felt tender and extremely tired.  Approximately 4 days after receiving the vaccination pt tried to do routine exercise and was unable to do so without resting at least twice during exercise.  Pt experienced back ache and soreness in her calf muscles.  These feelings gradually decreased over the next 10 days and pt felt about 90% better.				Y					Y	10/03/2007	10/06/2007	3		UNK	UNK	Toprol; Imitrex; Tylenol prn; OTC Calcium; Centrum Silver	No	Fibromyalgia; environmental allergies			1						1	Back pain; Fatigue; Musculoskeletal stiffness; Pain; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA303BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0294168	10/23/2007	MI	65.0	65		F	10/23/2007	1) 8 hrs after flu shot, sudden chills and racing pulse lasting 2 hrs.  2)next day,exhaustion, falling asleep, difficult to stand, weakness, sweating; fast pulse 3)sense of throat closing (took inhaler) or swelling 4) coughing, sore throat, hoarseness 5)sinus liquid running freely from the nose, dripping into throat 6)anti-biotics started with immediate curative effects.  I consulted with two doctors: it's just the symptoms, not the flu to it's just a coincidence, so it must be the flu									Y	10/01/2007	10/01/2007	0	none	UNK	PVT	Singulair, Evista, Lipitor, Carbatrol, Teldrin, Pantothenic Acid, Vicon C, Biotin Forte	none	allergic to dust, dander, fur, grass, perfume, mold--also allergic to silk and cat-gut	none~ ()~NULL~~In Patient|none~ ()~NULL~~In Sibling1		1						1	Asthenia; Chills; Cough; Dysphonia; Dysstasia; Fatigue; Heart rate increased; Hyperhidrosis; Pharyngeal oedema; Pharyngolaryngeal pain; Postnasal drip; Rhinorrhoea; Somnolence; Throat tightness	FLUX~UNKNOWN MANUFACTURER~do not know~5~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~do not know~1~IM~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0294169	10/23/2007	IL	1.0	0	1	M	10/23/2007	Prevnar shot in leg caused redness, swelling, hot to touch and pain at injection site										10/20/2007	10/21/2007	1		PVT	UNK		none				1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~UNK~~~MENINGOCOCCAL (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~UNK~~~VARICELLA (NO BRAND NAME)~1	USA		Influenza
0294171	10/23/2007	CA	45.0	45		F	10/23/2007	Approximately 16 hours after shot, had fever, chills, body aches, dizzy, nausesness, and vomiting. This was first flu shot. Patient had never had a flu shot prior to this shot.									Y	10/22/2007	10/23/2007	1		PVT	PVT	none	none	none			1						1	Chills; Dizziness; Nausea; Pain; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0294173	10/23/2007	CA	55.0	55		M	10/23/2007	Generalized myalgias, weakness, diarrhea				Y					N	10/10/2007	10/11/2007	1		OTH	PVT	DIOVAN; LIPITOR	Pre diabetes; hypertension	high cholesterol; NKDA			1						1	Asthenia; Diarrhoea; Myalgia	FLU3~SANOFI PASTEUR~U2449AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294174	10/23/2007	CA	72.0	72		F	10/23/2007	Patient states itching 1 day after injection, 2 days after injection develop area of redness, inferior to injection site warm, red, raised, tender extending near elbow. Treated with IM Ancef and Septra 05 BID x 10 days. Area inferior of Pneumovax injection.				Y					Y	10/12/2007	10/15/2007	3		PVT	PUB	COZAAR; LIPITOR; LEXAPRO; DETROL; FELDENE; CLARINEX	None	No known drug allergies; hypertension; hyperlipids; GERD			1						1	Erythema; Injection site erythema; Injection site pain; Injection site warmth; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA309AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0555U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294177	10/23/2007	DE	49.0	49		F	10/23/2007	Sore arm - low grade fever x 12-16 hrs									Y	10/19/2007	10/20/2007	1		OTH	PVT	None	None				1						1	Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U2453AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294179	10/23/2007	NC	0.9	0	.9	F		Fever of 102 F - 103 F. Jerking in sleep. One day - Motrin/Tylenol was given.									U	10/22/2007	10/22/2007	0	CBC with diff normal	PVT	PUB	None	Cough, Congestion, No fever	None			1						1	Dyskinesia; Full blood count normal; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B115DB~3~UN~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2458BA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08700B~3~UN~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0294180	10/23/2007	NH	71.0	71		F	10/12/2007	(L) arm edema and erythema within hours of injection tender to touch. No abscess or induration. Distal to injection site only present in Pneumovax site not influenza.										10/11/2007	10/12/2007	1	noted x 2 separate patients in 1 week, Pneumonia from different lots	PVT	PVT	Synthroid, HCTZ, Atenolol, Prilosec, Premarin, Aspirin MVI	None	None			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U2448AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0554U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294181	10/23/2007	TX				F	10/13/2007	Shot given on 10-10-07. That evening deltoid muscle was red with splotches. The next morning she had severe pain in shoulder which then progressively moved down to biceps muscle. 10-13-07 Came back to pharmacy with red, tender left biceps. We called her primary care MD and filled Keflex 500 mg # 28 - possible cellulitis versus local reaction. Spoke to husband on phone 10-17-07 - he says she is doing much better.									Y	10/10/2007	10/10/2007	0		UNK	PVT						1						1	Cellulitis; Erythema; Local reaction; Musculoskeletal pain; Myalgia	FLU3~SANOFI PASTEUR~U2466AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1035f~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294183	10/23/2007	KY	3.0	3		F	10/16/2007	site of injection-red quarter size, raised, warm to touch									Y	10/12/2007				PVT	PVT		None		red, warm~Varicella (no brand name)~1~2.50~In Patient|leg swollen~Varicella (no brand name)~1~0.00~In Sibling		1						1	Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294184	10/23/2007	KY	39.0	39		F	10/16/2007	1 1/2 - 2 1/2 red, raised area at injection site, warm to touch, itching. Injection on Friday - had to use inhaler q 4-6 hours until Sun PM - took chlortrimeton q 12 hours all weekend.									Y	10/12/2007	10/12/2007	0		PVT	PVT		None				1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2464AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294185	10/23/2007	NY	11.0	11		F	10/11/2007	5 minutes after shots complained of pruritus all over body-received Benadryl 25 mg-complained of increased itching 45 min later				Y						10/11/2007	10/11/2007	0		PUB	UNK		None	Seasonal Allergic Rhinitis Intermittent Asthma			1						1	Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80061~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B015AA~1~UN~~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1246U~2~UN~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0294187	10/23/2007	OR	24.0	24		F	10/09/2007	Very swollen painful injection site, fever 102.2 F, chills, muscle aches, fatigue, weakness.				Y					Y	10/02/2007	10/04/2007	2		OTH	PVT		None	Amoxicillin allergy			1						1	Asthenia; Chills; Fatigue; Injection site pain; Injection site swelling; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U2453AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0958F~1~SC~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294188	10/23/2007	OR	29.0			F		Major arm pain from shoulder to hand felt like a charlie horse. Red rash down my arm very feverish felt like an open blister scraping against sand paper. Severe Hot and cold flashes.				Y					Y					OTH	OTH		None				1						1	Feeling of body temperature change; Pain in extremity; Pyrexia; Rash; Skin warm	FLU3~SANOFI PASTEUR~U2453AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0958F~1~SC~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294189	10/23/2007	NY	80.0	80		F	10/18/2007	Arm swelled on outside and turned red-Several hrs later inside arm from arm pit to elbow swelled and turned bright red lasted for 2 days-on third day began to subside and red faded									Y	10/10/2007	10/10/2007	0		PUB	UNK	None					1						1	Erythema; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0294190	10/23/2007	WI	70.0	70		F	10/19/2007	Patient complained of pain in arm and redness and heat down back of arm from shoulder to elbow.									Y	10/17/2007	10/18/2007	1		OTH	OTH						1						1	Erythema; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~U2450AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1132U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294191	10/23/2007	MA	12.0	12		F	10/22/2007	Pt developed severe fatigue, nausea with abdominal pain, and subjective complaint of weakness after her 2nd  dose of Gardasil (seen 1st 3/27/07 for this problem). Symptoms have persisted since that time.									N	02/12/2007	03/20/2007	36		PVT	PVT		None	None			1						1	Abdominal pain; Asthenia; Fatigue; Nausea	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0955F~3~IM~UN~HPV (GARDASIL)~1	USA		Influenza
0294192	10/23/2007	WI	79.0	79		F	10/19/2007	Pain and redness - 4 x 2 area - located 1-2 below injection site - (L) deltoid.									U	10/17/2007	10/18/2007	1		PUB	PVT						1						1	Erythema; Pain	FLU3~SANOFI PASTEUR~U2464AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294193	10/23/2007	NC	15.0	15		F	10/23/2007	At 610 PM received call from stating pt had flu shot today. Went home and took a run. She came back c/o having a hard time breathing. Mom reported breaking out on neck, back, both arms, both legs, and chest area. Mom instructed to give Benadryl and call 911 if symptoms worsened.									Y	10/22/2007	10/22/2007	0	N/A	PVT	UNK		None	Asthma, Allergic rhinitis			1						1	Dyspnoea; Rash	FLU3~SANOFI PASTEUR~U2457DA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294194	10/23/2007	TX	51.0	51		F	10/23/2007	Redness and itching at injection site.									Y	10/20/2007	10/21/2007	1		OTH	PVT		None	None			1						1	Injection site erythema; Injection site pruritus	FLU3~SANOFI PASTEUR~U2499AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294195	10/23/2007	AK	65.0	65		M	10/20/2007	Joint pain, muscle spasms, skin on fire, severe pain level 7-8. Patient experienced rash at injection site, pain in whole left shoulder area up to ear, skin felt like it was on fire and tingly sensation in feet. 10/19/07 Went to Dr who thought he was having a heart attack and sent him by ambulance to ER. He was there 7 hrs. Did EKG and blood tests to confirm no MI. They determined it was an adverse rxn to the flu shot.				Y					N	10/18/2007	10/19/2007	1	EKG/Blood tests at ER confirmed no MI/ normal labs.	OTH	OTH	Amloa/Benaz	Immunosuppressed	Cancer			1						1	Arthralgia; Blood test normal; Electrocardiogram normal; Immunisation reaction; Injection site rash; Muscle spasms; Pain; Paraesthesia; Skin irritation	FLU3~SANOFI PASTEUR~U2453AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294196	10/23/2007	VA	16.0	16		M	10/23/2007	Influenza, Hep A, Menactra and Varicella administered. Patient began to experience hives, hitching, SOB and increased HR about 20 min after administration - given Epinephrine 0.5 ml IM to (L) deltoid.				Y					Y	10/19/2007	10/19/2007	0		PVT	PUB	Administered Epi 0.5 ml IM given		History of Kidney transplant 12-23-98			1						1	Dyspnoea; Heart rate increased; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2461BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1209F~1~IM~LA~HEP A (VAQTA)~1|MNQ~SANOFI PASTEUR~U2404AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~1251U~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0294198	10/23/2007	CA	1.4	1	.4	F	10/21/2007	Erythema multiforme starting appx 2 days after vaccination with flu shot.				Y					U	10/18/2007	10/20/2007	2		PVT	PVT		None	None			1						1	Erythema multiforme	FLU3~SANOFI PASTEUR~UT2456FA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294199	10/23/2007	AK	52.0	52		F	10/22/2007	Large red swollen arm 48 hours after administration of DTaP and Flu in left deltoid. Resolving on 10/22/07.									Y	10/16/2007	10/18/2007	2	None	PVT	PVT	Synthroid, Zocor, Nexium	None	NKDA			1						1	Erythema; Oedema peripheral	DTAP~SANOFI PASTEUR~C2825AA~1~UN~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~AFLLA047bA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294172	10/24/2007	MD	62.0	62		F	10/24/2007	Approximately two (2) hours after the shot, I experienced extreme fatigue and lethargy and went to bed at 7:00 pm and slept until 4:45 AM.									Y	10/22/2007	10/22/2007	0		UNK	UNK	Vytorin, Norvasc, Famotodine, Nexium, Lomotol, Levoxyl	N/A	Thyroid Cancer, high blood pressure, cholesterol			1						1	Fatigue; Lethargy	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0294225	10/24/2007	TX	0.63	0	.6	F	10/23/2007	Information has been received from a physician concerning a 7 month old female with history of renal anomaly who on 21-SEP-2007 was vaccinated PO with her third dose of Rotateq (lot # 657660/0972U). Concomitant vaccinations administered on that day included a dose of PEDIARIX, a dose of PREVNAR, and a dose of influenza virus vaccine (unspecified). Other concomitant drug therapy included prophylactic antibiotics and BACTRIM. On that same day, the patient experienced vomiting of blood and vomiting. The patient was taken to the ER and was subsequently sent back to a hospital for further observation. Subsequently, the vomiting and vomiting of blood resolved quickly and the patient was recovered. There was no product quality complaint. Additional information has been requested.				Y	Y				Y	09/21/2007	09/21/2007	0	Unknown	OTH	OTH	antimicrobial (unspecified); BACTRIM		Renal aplasia		WAES0710USA03846	1						1	Haematemesis; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~DTAP + HEPB + IPV (PEDIARIX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PNC~PFIZER\WYETH~~UNK~UN~UN~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0972U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0294229	10/24/2007	NJ	61.0			M	10/23/2007	Information has been received from a certified medical assistant concerning a 61 year old male who on 11-OCT-2007 was vaccinated SC in the left arm with a dose of Pneumovax 23 (lot #656233/0200U). Concomitant therapy included influenza virus vaccine (unspecified). On 11-OCT-2007, the patient developed an enlarging lump with pain, fever and tenderness in the left injection site arm. On 12-OCT-2007, the patient presented to an emergency room, and subsequently, was hospitalized with cellulitis and possible abscess at the injection site of the left upper extremity. On an unspecified date, the patient was discharged. At the time of this report, the patient was recovering. A concern regarding the lot was reported. Cellulitis and possible abscess at injection site were considered to be disabling events. Additional information has been requested. The medical assistant also reported another patient who developed an adverse experience after vaccination with Pneumovax 23 (lot # 656233/0200U) (WAES #0710USA03567).				Y	Y	0	Y	Y	N	10/11/2007	10/11/2007	0	Unknown	OTH	OTH			None		WAES0710USA03557	1						1	Injection site abscess; Injection site cellulitis; Injection site mass; Injection site pain; Pain in extremity; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0200U~1~SC~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation,Disabling	Influenza
0294233	10/24/2007	NY	38.0	38		F	10/18/2007	Flu shot done on 10/2 then 4 hours later she had a reaction which got worse and caused her to have severe vertigo, large amount of pressure in her head, temp loss of vision in 1 eye, and septical (viral) meningitis; wants to find out if this from the flu and if the injection medication can be tested. Primary care an Neurologist were concerned and provided with the lot info. Manufacturer not notified but advised the complainant to do so. Complainant saw several specialist in the hospital including a Rheumotologist, ENT, Neurologist Had previous autoimmune disease since teenager. The complainant will try to return to work on Monday 10/22/07 and she works from 8a-5p. 10/19/07 complainant called back after she notified manufacturer of complaint and was provided a case number of NA07-005083.  12/18/07 Reviewed hospital medical records which reveal patient experienced right sided transient vision loss, HA & scalp tenderness.  Admitted 10/5-10/15/2007.  D/C on tapering steroid dose to f/u in rheumatology & neurology clinics. FINAL DX: vestibular neuronitis, possible antiphospholipid syndrome, migraine HA and possible aseptic vs viral meningitis. Per 60 day follow up: Diagnosed with viral meningitis. Still having neurology problems. Prognosis: Recovery could take up to 1 year. 1/15/2010 I am still having ongoing issues with nausea and vertigo. I wasl also diagnosed with Lupus.			Y		Y	10			N	10/02/2007	10/02/2007	0	LABS: ESR 68.  MRI/MRA WNL.	UNK	UNK			Had previous autoimmune disease since teenager. PMH: Bells palsy, ITP, migraines			1						1	Headache; Meningitis viral; Migraine; Nausea; Tenderness; Vertigo; Blindness transient; Deafness unilateral; Dizziness; Headache; Malaise; Meningitis viral; Vomiting; Dizziness; Ear discomfort; Headache; Intracranial pressure increased; Meningitis aseptic; Tinnitus; Vertigo; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78990~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78990~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~2|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78990~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~3	USA	Life Threatening,Hospitalisation	Influenza
0294234	10/24/2007	KY	56.0	56		M	10/23/2007	10/12 Headache, redness and swelling at injection site. 10/14 Low back pain. 10/15 Leg pain. 10/16 Severe leg and back pain, deep ache with burning sensation - to hosp. E.R. 10/19 Increased severe leg and back pain with weakness - to PMD. 10/20 Admitted to hospital. 1/22/08-records received for DOS 10/20-10/30/07 DC DX: Guillain-Barre syndrome with severe paresthesias and pain, bialteral muscle weakness, plsmapheresis. Pain, anxiety, plasmapheresis catheter infection with methicillin-sesnsitive Staphylococcus epiermidis. Dysuria with normal urinalysis, severe constipation, left foot pain with swelling, general deconditioning and symmetric peripheral weakness including facial weakness and pocketing food during meals. Then traveled out of state at which time had severe pain in buttock and thigh. Tingling and numbness.Transferred to rehab.   9/19/08 Received additional medical records. ER records of 10/16/07 reveal patient had HA & diarrhea week before.  Then developed low back pain, knee pain & skin sensitivity.  Labs were unremarkable.  Tx w/pain meds & d/c to home.  Rehab records of 10/30-11/5/2007 reveal patient tx w/IVIG x 5.  D/C to home w/walker & TENS unit.  Had continued paresthesias			Y	Y	Y	10	Y		U	10/06/2007	10/12/2007	6	Guillain-Barre' Syndrome 1/22/08-records received- MRI foot normal. Ct abdomen and pelvis small left renal cysts and diverticulitis. WBC 17.5. Urinalysis trace blood. Hyponatremia, CRP elevated 5.1, serial cardiac markers negative. ganglioside monosialic acid screen for GM-1 antibodies and asialo GM-1 negative.   LABS: 10/19/2007 MRI T-spine WNL.  MRI L-spine w/disc bulges & mild narrowing of spinal canal & neural foramina.  Borrelia neg.	PUB	PUB	None	None 1/22/08-records received- Five days after flu vaccine developed diarrhea and headache.	None 1/22/08-records received-PMH: hypertension, anxiety, constipation, BPH.			1						1	Asthenia; Back pain; Burning sensation; Guillain-Barre syndrome; Headache; Injection site erythema; Injection site swelling; Pain in extremity	FLU3~SANOFI PASTEUR~U2445NA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0294236	10/24/2007	MA	0.5	0	.5	M	10/22/2007	Intussusception.  11/02/07 Reviewed medical records from 2nd ER of 10/19/07 which reveal patient experienced pulling up of legs, vomiting & apparent abdominal pain.  Seen in outlying ER & admitted overnight.  Tx w/IVF & serial abdominal exams.  D/c to home & had continued gagging, reduced oral intake, irritability, decreased sleep & uncomfortable abdomen.  BE reduced IS & admitted overnight for observation s/p reduction. FINAL DX: Intussusception, enema reduced. Records faxed to CDC. 11/13/07 Reviewed hospital medical records which reveal patient experienced vomiting, fever & abdominal pain.  Admitted 10/18-10/19/2007. Abdomen was diffusely tender.  Tx w/IVF, antipyretic & antinausea meds.  Improved & d/c to home. ER Diagnosis: dehydration, vomiting & abdominal pain. Seen at outlying hospital for persistent vomiting where IS was dx & reduced by BE.  Admitted overnight for observation & d/c to home.   Continued to run fever & had diarrhea & returned to ER.  Temp 103 in ER.  Tx w/antipyretic & d/c to home. Final ER dx: fever secondary to vaccines. Records faxed to CDC. 11/16/07 Received vax record from pcp which confirms RO dose & lot as reported.  Record faxed to CDC.				Y	Y	3			Y	10/17/2007	10/17/2007	0	Ba Enema LABS: Abdominal x-ray & KUB revealed colo-colic IS.  Barium enema successful.   LABS: KUB WNL. Platelets 512 (H), neutros 75% (H), lymphs 11% (L), monos 12% (H).  Total protein 6.0.  Alk phosphatase 254 (H).  UA WNL.	PVT	PUB		Nasal congestion - No fever	None			1						1	Barium enema; Intussusception	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B127AA~3~UN~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U245BA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF192AA~3~UN~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B47300F~3~UN~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0408U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0294240	10/24/2007	CA	65.0	65		F		Extreme pain at site of injection. Patient said she could not sleep. Better on 10/13; completely fine 10/17. No residual effects.									Y	10/11/2007	10/12/2007	1		OTH	PUB		None				1						1	Injection site pain; Sleep disorder	FLU3~SANOFI PASTEUR~0803U~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~U2498AA~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294241	10/24/2007	MD	51.0	51		F	10/15/2007	Client states she received flu shot at about 08:30/AM on 10/9, Rt arm was sore after shot. By 4AM, client states she had acute pain in her Rt shoulder with radiation down her Rt arm into her hands with decreased mobility in hands. She states she feels a jumping nerve like sensation in the inner aspect of her RT arm 10+. The area is painful to touch and she cannot move well. She has been taking Ultram since the inj secondary to the pain and immobility thinking it would get better and it has not. Client was given ice and BR and referred to her PMD.				Y					U	10/09/2007	10/10/2007	1	Not done at time of this report.	OTH	PUB		None	Sinus and Arthritis			1						1	Injected limb mobility decreased; Musculoskeletal pain; Nervousness; Sensory disturbance	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78994~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0294242	10/24/2007	MI	30.0	30		F	10/18/2007	Client received flu vaccine at Emergency Management Drill. She reported no hx of egg or latex allergy and no reaction from previous flu shots. She did report being allergic to sulfa and augmentin. She was instructed to wait 15 after vaccine, but chose to drove off. She then developed SOB, chest pain, and nausea, and returned to clinic site. She was then transported to ER by ambulance, where she received Epinephrine and oral steroids. She was d/c'd from ER after 45 minutes.				Y					Y	10/17/2007	10/17/2007	0	None	PUB	PVT	Wellbutrin, Lexapro, Acyclovir, Birth Control Pills	None	Lupus			1						1	Chest pain; Dyspnoea; Nausea	FLU3~SANOFI PASTEUR~U2440AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294243	10/24/2007	NH	48.0	48		F	10/18/2007	Approx after 1 hour pt became flushed, face reddened and developed itchy flat rash neck/arms bilaterally with tight feeling around mouth. Took Benadryl 50mg and sx began resolving after 20 minutes. Pt rash lessening but remained on arms. Advised to take exact dose every 6 hours.									Y	10/18/2007	10/18/2007	0	None	PVT	PVT		None	Allergic Cherries/PCN; GERD/Hyperlipidemia			1						1	Erythema; Flushing; Rash; Rash pruritic; Skin tightness	FLU3~SANOFI PASTEUR~U2469AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294246	10/24/2007	CA	54.0	54		F	10/24/2007	Light-headed, dizzy, slight puffiness near injection site, started to pass out but not totally. Vitals - ok; BP slightly low. Treated with Diphenhydramine 50mg p.o. Responded well, went home and slept for 1 1/2 hours. Follow up phone call on 10/24 at 2:05 PM - No adverse effects. She felt strong and well.									Y	10/23/2007	10/23/2007	0		OTH	PVT	Arimedex for approximately 4 years	None	Penicillin			1						1	Blood pressure decreased; Dizziness; Injection site swelling; Presyncope	FLU3~SANOFI PASTEUR~U2515AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294247	10/24/2007	FL	57.0	57		F	10/24/2007	(R) arm/deltoid - pain, soreness, warmth, erythema, swelling, induration - extending around front of arm, and toward elbow.									Y	10/22/2007	10/23/2007	1	BP 130/60; P 58; R 16; T 98.6	OTH	UNK	Lexapro; Diovan; Atenolol; Nasonex; Dinalire; Tramadol; Calcitrate	None	Hypertension, Depression			1						1	Erythema; Induration; Pain in extremity; Skin warm; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA302AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0963U~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294250	10/24/2007	MI	11.0	11		F	10/24/2007	Child presented to office on 10-22/07 w/ 8 1/2 x 11 cm circular patch on (L) back of upper arm after vaccine given on 10-18-07. The only vaccine given in that area was Varicella. Had fevers 100-101 previously after shots also.										10/18/2007	10/19/2007	1	None	PVT	PVT	Singulair; Advair; Prevacid; Cortef; Florinef	None	Congenital adrenal hyperplasia; Asthma; Allergies			1						1	Injection site erythema; Pyrexia	FLU3~SANOFI PASTEUR~U2516AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1061U~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2427AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B021CB~6~IM~LA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1255U~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0294251	10/24/2007	NM	45.0	45		F	10/23/2007	Times are approx. 0845 - Flu vaccine administered in right upper arm. 0905 - Lightheaded/dizzy, voice very hoarseness. 0907 - Nauseous, hives starting. 0910 - Told nurse was getting ill, started itching due to hives, knew what I wanted to say but could not talk properly. Tongue felt swollen. 0915 - Wheel chaired by nurse to ER. 0920 - Skin observed by doctor - red, blood pressure high, incoherent, confused. 0925 - Benadryl administered thru IV, fell asleep. 1230 PM - ER released me - still felt ill and confused, hives continued for 2 days, muscles very sore, very weak.				Y					N	10/15/2007	10/15/2007	0	ER took blood test - unknown results	MIL	OTH	Effexor; Premarin; Clonazepam; Klonopin; Methrocin	On record at hospital	On record at hospital, allergic to numerous medications and latex, Betadine, Iodine, Benadryl			1						1	Asthenia; Blood test; Confusional state; Dizziness; Dysphonia; Erythema; Hypertension; Incoherent; Malaise; Myalgia; Nausea; Pruritus; Swollen tongue; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0294254	10/24/2007	VA	82.0	82		M	10/23/2007	Pt received 2 doses of Pneumovax within an approximate 6 weeks period of time.									Y	10/18/2007			None	OTH	PVT		In facility for rehab.	Metastatic Prostate Ca.; HTN; COPD; Falls; GERD; Tachycardia; DM-Type 2; Tremors; NKDA			1						1	Inappropriate schedule of drug administration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1132U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294255	10/24/2007	TX	57.0			F	10/22/2007	7 day flu like symptoms. No treatment.									Y					OTH	PVT						1						1	Influenza like illness	FLU3~SANOFI PASTEUR~U2466AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294256	10/24/2007	TX				U		7 days flu like symptoms. No treatment.									Y	09/20/2007	09/20/2007	0		OTH	UNK						1						1	Influenza like illness	FLU3~SANOFI PASTEUR~U2466AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294257	10/24/2007	TX	56.0	56		M	10/24/2007	Skin rash, hives - note patient not allergic to eggs, Thimerosal, gelatin, Neomycin, or Gentamycin.				Y					U	10/12/2007	10/13/2007	1		OTH	PVT		None	None			1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~U2452AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294258	10/24/2007	MO	15.0	15		F	10/24/2007	10-24-07 Pt Rt arm is red, swollen, tender to touch. Fever 100-102. Area is red about size of 9 1/2 tall, 6 1/2 wide redness. Very painful.				Y					U	10/22/2007	10/23/2007	1		PVT	UNK	Zoloft	None	Supraventricular tachycardia - surgery 2006			1						1	Erythema; Oedema peripheral; Pain; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~U2502AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2155CA~1~IM~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PPV~MERCK & CO. INC.~1344U~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294261	10/24/2007	FL	80.0	80		F	10/24/2007	Extreme nervousness at bedtime with many body movements, with very little control.  No fever, but gave her two Tylenol PM gelcaps to help her sleep.									Y	10/23/2007	10/23/2007	0		UNK	UNK						1						1	Dyskinesia; Nervousness	FLUX~UNKNOWN MANUFACTURER~u23411RA~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0294262	10/24/2007	NJ	60.0	60		F	10/24/2007	SEVERE RIGORS, FEVER TO 100.8 AND MUSCLE ACHING LASTING 12-14 HRS. RESPONDED TO TYLENOL AND WARMING.				Y					Y	10/22/2007	10/22/2007	0		UNK	PVT		NONE	NONE			1						1	Chills; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U2446AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294263	10/24/2007	NM	79.0	79		F	10/24/2007	PATIENT RECEIVED PNEUMOVAX (LEFT ARM) AND FLUZONE (RIGHT ARM) ON SUNDAY 10/21/07 AROUND 3:00. PATIENT REPORTS SHE BEGAN TO EXPERIENCE REDNESS AND PAIN IN LEFT ARM LATE THAT EVENING. SAW A VISITING NURSE TUESDAY 10/24/07, WAS REFERRED TO EMERGENCY ROOM. PATIENT DIAGNOSED WITH CELLULITIS AND GIVEN ANTIBIOTIC TREATMENT FOR 10 DAYS.				Y					U	10/21/2007	10/21/2007	0		UNK	UNK						1						1	Cellulitis; Erythema; Pain in extremity	FLU3~SANOFI PASTEUR~U2454AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0061U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294265	10/24/2007	NH	36.0	36		F	10/24/2007	Patient had significant swelling to her right upper arm with hours after her injection.  No redness, warmth, fever, chills, or any other signs of infection noted.  Patient was instructed to use ice to area and benadryl as needed									Y	10/09/2007	10/09/2007	0		PVT	UNK	humalog; dovonex cream, uses insulin infusion pump, albuterol, valtrex prn, maxalt prn.	no known illness	allergies:  bactrim; effexor & steroid nose sprays-glaucoma; dx:  type 1 DM, polyarthritis, psoriasis, granuloma annulare, cataracts, glaucomea, neuropathy, headaches, neuralgia			1						1	Oedema peripheral	FLU3~SANOFI PASTEUR~u2457fa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0993u~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294267	10/24/2007	MI	54.0	54		F	10/24/2007	Received vaccine on October 19, 2007 in A.M. The next day, Sat. 10-20-2007, had mild facial swelling,  sensitive to the touch, and headache.  She took 400 mg of Ibuprofen, for relief of the headache.  On Sun. 10-21-2007, had more pronounced facial swelling, around sinusus, bridge of nose and eyes. Developed a red,raised rash on the inner aspect of her upper arms, the nonhairy skin surface of the underarms. It was itchy. She took 25 mg of Benadryl for relief.  On Mon. 10-22-2007, had more facial swelling and rash continued, so she took 25mg of Benadryl for relief.									Y	10/19/2007	10/20/2007	1	None	PUB	PVT	Amaxide for blood pressure and Boniva once monthly	None	hypertension, calcium deficiency	None~ ()~NULL~~In Patient		1						1	Headache; Pruritus; Rash; Sensory disturbance; Swelling face	FLU3~SANOFI PASTEUR~U2478BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294268	10/24/2007	NC	0.8	0	.8	F	10/24/2007	Child was given an influenza vaccine on the afternoon of 10/22/07 at approximatly 3pm.  At 3am on 12/23/07 mom wake to find the chidl with fever.  The child then began to seize.  Mom felt that seizure was focal and that it began with the left hand and arm.  She cannot be certain of this though.  Child was taken to the ED and ativan was need to stop the seizure.  On arrival to ED the seizure was generalized in nature.  Total duration was about 20 to 25 minutes of seizure time. 11/20/07-records received for DOS 10/23-10/24/07-DC DX: Febrile seizures possibly atypical with the concern about initial focal left-sided seizure that later generalized although the mother is not fully confident that it was localized. Presented to ED actively seizing. Temperature in ED 103.8. At home crying twitiching of left arm and left leg. Staring with eyes open. In ED generalized seizure observed lasting 20-25 minutes. Twelve hours prior to onset of seizure seen in PCP office because she was pulling at her ears and not sleeping well for 24-48 hours. PE in office ears normal.				Y	Y	1			Y	10/22/2007	10/23/2007	1	Die to questionable focal nature, prolonged seizure and prolonged somnelent state after seizure(possibly due to ativan), a CT scan was done with adn without contrast and LP was done.  Both were normal.  Child was obxerved in hospital for 24 hours and then discharged.  EEG will be done due to possible focal seizure. 11/20/07-records received-Chemistry WNL. CT scan and spinal fluid normal. Cultures of urine, spinal fluid and blood negative.	UNK	UNK	none	none	Recurrant otits media 11/20/07-records received-HX of otitis media.			1						1	Computerised tomogram normal; Convulsion; Lumbar puncture normal; Pyrexia	FLU3~SANOFI PASTEUR~ut2474aa~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0294269	10/24/2007	MI	52.0	52		F	10/24/2007	RECEIVED VACCINE AT 3PM, ONSET OF SYMPTOMS AT 6PM-VOMITING, CHILLS, FEVER, HEADACHE				Y					Y	10/21/2007	10/21/2007	0	CBC DONE IN ER	PUB	UNK		NONE	DIABETES			1						1	Chills; Full blood count; Headache; Pyrexia; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80957~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0294270	10/24/2007	WA	68.0	68		M	10/24/2007	2 days after Fluzone was given I developed severe chills and fever and severs uncontrolable shaking of my head, upper limbs, and headache.  the next day the symptoms were gone. I am a retired physician and in good health and feel the the above was directly related to the fluzone.									Y	10/17/2007	10/19/2007	2		UNK	PUB	vasotec 20 mg/day	none	sulfa			1						1	Chills; Headache; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~tx 1845211~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294272	10/24/2007	MI	83.0	83		F	10/24/2007	2 inch by 2 1/2 inch indurated, mildly erythematous area around site of sc PPV23 given on 10/23/07 in posterior right upper arm.  No systemic S/S of reaction.									Y	10/23/2007	10/24/2007	1		PUB	UNK	Levaquin 750 mg IV every day for UTI with fever and delirium on 10/22/07, Tylenol 325 mg every 4 hrs prn, Darvocet N 100 po BID	UTI.  Delirium and fever were resolved on 10/23/07 after IV antibiotics.	Morphine makes her dopey  otherwise NKDA			1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~.02486AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~08044.~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294273	10/24/2007	CA	65.0	65		F	10/24/2007	Muscle weakness left upper arm and left shoulder since 10/1/2007 (date of flu vaccinations).  Also left shoulder joint pain with movement and limited range of motion. Left arm paresthesia and on down to left 5th finger.									Y	10/01/2007	10/01/2007	0	None.  NKA	PUB	PVT	NONE	NONE	NONE			1						1	Arthralgia; Joint range of motion decreased; Muscular weakness; Paraesthesia	FLU3~SANOFI PASTEUR~U2441AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294274	10/24/2007	NJ	72.0	72		M	10/24/2007	Patient's daughter called after the event and reported that patientexperienced wheezing, cough and syncope later that day after he returned home from flu clinic.  She did not indicate which, if any, hospital he was taken to, but that she had called his physician. Cardiologist.  She reported that her father died on Sunday 10-21-2007 11/6/07 Received hospital clinic & cardiology medical records which reveal patient experienced CAD, s/p CABG (1982 & 1990) & severe LVD s/p ICD biventricular deployment; chronic back problems; hyperlipidemia; diabetes type 2; & controlled HTN.  Cardiac cath of 4/2006 revealed patent left internal mammary arter to LAD bypass graft w/other grafts being occluded.  Had been hospitalized 7/07 for pacemaker device discharge.  Had DOE at that time.  Pacer rate was increased due to myocardial ischemia.  Developed chest pain, nausea & additional DOE.  Dx w/unstable angina 7/11/07 & admitted to hospital.   1/18/08 Reviewed ER records of 10/22/07 which reveal patient fell & had witnessed cardiac arrest at home 50 min prior to arrival in ER.  Had been intubated & IV access placed in field.  ECG revealed V-fib & then asystole & patient expired 10/22/07. 1/29/08 Cardiac arrest per death certificate.	Y	10/22/2007							N	10/20/2007	10/20/2007	0		UNK	UNK		This was a Public Health Mass Immunization clinic.  This patient does not come here for routine care.  We know that he had had flu vaccine in the past, has a GI upset reaction to eaten eggs, but still eats them, and reported no febrile illness in the 48 hours prior to vaccination and was not allergic to thimerisol	Discussion with cardiologist listed above revealed that the patient was under his care for a significant heart condition and that the doctor does not believe that the immunization contributed to the patient's demise.  He stated that if the patient had been in his office, his risk factors would have warranted vaccination with influenza vaccine. PMH: ischemic cardiomyopathy, ejection fraction 20%; CHF class 2-3; ventricular tachycardia; chronic renal insufficiency; multiple CVAs; COPD; PVD; chronic pain. PMH: MI, HTN, CABG x 5, cardiac stents, pacemaker.  Abdominal aneurysm.			1						1	Cough; Death; Syncope; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78476~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0294277	10/24/2007	MI	60.0	60		F	10/24/2007	Fri. 10/19/2007 8:00a.m. received Fluzone.  Sat. 10/20/2007 at 1:00 p.m. while riding in the car, felt nauseous and had a bad headache. Went to lunch, was able to eat. While driving felt nauseous again and headache was worsening. At first stop, got out of car and laid on the lawn. Then went inside (her mother-in-law's house)and slept for one hour.  Then returned home, took two extra strength Tylenol tablets and slept for three hours more. Then she got up and ate a piece of apple and was recovered.									Y	10/19/2007	10/20/2007	1	None.	PUB	PVT	Synthroid, Vitorin, and weekly, takes Fosamax	none	Takes Synthroid for hypothyroidism,Vitorin for cholesterol control and Fosamax for prevention of osteoporosis	No~ ()~NULL~~In Patient|No~ ()~NULL~~In Sibling1		1						1	Headache; Nausea	FLU3~SANOFI PASTEUR~U2478BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294282	10/24/2007	MN	45.0	45		F	10/24/2007	Quizzie about 20 minutes after vaccination,then more nuaseated, burning in chest, light headed, HA and cold Sweat.  Seen in ED                           States had similiar reaction 8-9 years ago.				Y					N	10/23/2007	10/23/2007	0	EKG---fast rate----Took blood	UNK	PVT	amytriptylline, mircette 28day, tylenol, ibuprofen	no illness at time of vaccination	had a reaction caines--skin turns really red.  Has had a similiar reaction to the Flu vaccine 8-9 years ago.	nausea, vomiting, HA~Influenza (Seasonal) (no brand name)~1~36.00~In Patient		1						1	Chest pain; Cold sweat; Dizziness; Electrocardiogram; Headache; Nausea; Similar reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~U2457HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294286	10/24/2007	ND	9.0	9		F	10/24/2007	Child had no appetite on 10/18/1007, she had vomiting for 24 hours with the vomiting stopped by 10/20/2007.  A rash appeared on her trunk, arms, face and legs on 10/19/2007.  She c/o of itching.  Mom compared the rash to a heat rash.  Mom states the child has continued her normal activities. The rash has not subsided.									U	10/10/2007	10/18/2007	8	None	PUB	PVT	Claritin 1 tab po daily	None	None			1						1	Anorexia; Heat rash; Pruritus; Rash; Vomiting	FLU3~SANOFI PASTEUR~U2439AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294288	10/24/2007	OR	55.0	55		F	10/24/2007	10/19/2007 Vet calls with report of flu sxs, cough, sore throat, chills, fever since this  am. She says, she received a flu shot on 10/16/2007at MC.  Follow up call done on 10/22/07 with symptoms decreasing to afebrile, chest congestion and cough.  Pt states that 10/20 was worst day, but feels progressively better.									Y	10/16/2007	10/19/2007	3	None	UNK	UNK	None with Vaccination, present meds: Clotrimazole, Albuterol, carisoprodol, levotyroxine, simvastatin, loperamide, calcium, hydroddone, metformin	No	HTN, Tobacco  use, Arthalgia, DMtype @, Hypothyroidism, obesity  Allergies: Tylenon, Bentyl, Cyclobenzaprine, Loratadine	Flu like symtoms~Influenza (Seasonal) (no brand name)~UN~25.00~In Patient		1						1	Chills; Cough; Influenza; Pharyngolaryngeal pain; Pulmonary congestion; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81270~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0294290	10/24/2007	CA	12.0	12		M	10/24/2007	Fever, headache, sore throat, coughing, body aches, chills, vomiting and difficulty breathing--respiratory infection. He went to the doctor healthy and left out sick--he missed one complete week of school due to getting the FLU VACCINE.									Y	10/10/2007	10/11/2007	1	N/A	UNK	UNK	Albuterol inhaler as needed, Singulair, albuterol saline and Pulmicort saline as needed only (for machine)	No.	Child is asthmatic	~Influenza (Seasonal) (Fluzone)~1~12.00~Patient		1						1	Chills; Cough; Dyspnoea; Headache; Pain; Pharyngolaryngeal pain; Pyrexia; Respiratory tract infection; Vomiting	FLU3~SANOFI PASTEUR~U2443AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294293	10/24/2007	CO				U	10/24/2007	Staff erroneously drew up 1 cc instead of 0.5 cc for each injection.  We, therefore, gave out approximately 200 immunizations instead of the 400 or so needed. a second wave delivery of Flu vaccines is reportedly, which will										10/25/2007	10/25/2007	0		UNK	PUB		None	Unknown			1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~U2502AA~4~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294294	10/24/2007	CA		71		F	10/24/2007	Patient recieved both the flu vaccine and the pneumococcal vaccine in the left deltoid.  Both vaccines were administered one inch apart.  Patient stated that she recieves annual flu shot and was also due to her pneumonia shot.  Patient was asked if she whould like both shots in one arm one inch apart (as there was no history of prior adverse event with either vaccine).  Patient stated that that evening after the vaccine she experienced prolonged arm soreness, some flu like symptoms, some neck ache, and that she was not able to sleep until the following morning due to the extreme arm soreness in her left arm.  Patient was afraid to take Aspirin to the soreness because thought it would interact with the vaccine.  I spoke with the patient the following morning at 11:45 am and she stated that she had taken aspirin earlier in the day and had slept for a few hours.  The patient stated that the soreness was subsiding.  I informed the patient to take what she would normally take for a headache or minor pain and if the soreness continued to contact the pharmacy and I would call her.									Y	10/16/2007	10/16/2007	0		UNK	UNK		none				1						1	Influenza like illness; Insomnia; Neck pain; Pain in extremity; Body temperature increased; Pain in extremity; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~LA~PNEUMO (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0294295	10/24/2007	AR	41.0	41		F	10/24/2007	Terrible swelling at injection site (like a softball) with horrific pain in the muscle and shoulder joint!  Red, patchy rash covering almost entire upper arm from elbow to shoulder joint!									Y	10/22/2007	10/22/2007	0		PVT	PVT						1						1	Injection site pain; Injection site swelling; Musculoskeletal pain; Myalgia; Rash erythematous	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0294298	10/24/2007	MA	1.0	1	.0	M	10/24/2007	Pink, slightly tender, warm right leg. 3-4 day symptoms. Raised area 1-2 cm, resolved over 1 week.									Y	09/20/2007	09/20/2007	0	None	PVT	PUB	None	None	None			1						1	Erythema; Skin warm; Swelling; Tenderness	FLU3~SANOFI PASTEUR~UT2456BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB163AB~1~IM~RL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~B47442E~4~UN~UN~PNEUMO (PREVNAR)~1	USA		Influenza
0294299	10/24/2007	MN	22.0	22		F	10/24/2007	Patients left 2nd, 3rd, and 4th fingers have been numb since receiving flu shot on 10/2/07.									U	10/02/2007	10/02/2007	0	None	PVT	PVT	Prenatal Vitamins	None	None			1						1	Hypoaesthesia	FLU3~SANOFI PASTEUR~U2487AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294300	10/24/2007	IA	64.0	64		M	10/23/2007	(L) arm at site of pneumonia (pneumococcal) vaccine red, swollen, warm to touch.				Y					Y	10/18/2007	10/21/2007	3		PUB	PUB		None	Allergic to Sulfa, MI, Diabetes			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2449AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0380U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294301	10/24/2007	WA	1.6	1	.6	M	10/18/2007	High fever to 101.9 (ax) 2 days after vaccine Given. No identified source of fever.				Y					Y	10/16/2007	10/18/2007	2	Rapid strep -; WBC 18.5	PVT	PVT		None	None			1						1	Pyrexia; Streptococcal identification test; White blood cell count increased	FLU3~SANOFI PASTEUR~UT2459LA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294304	10/24/2007	NH	10.0	10		M	10/24/2007	6 diameter area of induration, tenderness at site of Varivax #2 shot 18-48 hours afterward.									Y	10/17/2007	10/18/2007	1	None	PVT	PUB	None	None	None		NH0742	1						1	Injection site induration; Injection site pain	FLU3~SANOFI PASTEUR~U2507AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~B186BO~1~IM~LA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~0781V~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0294306	10/24/2007	TX	60.0	60		M	10/24/2007	Given Fri AM after getting flu shot earlier that morning. No immediately symptoms. 36 hours later noted red bump in middle of forehead. ? small blisters in lesion but no oozing/discharge. Over past 5 days, marks slowly resolving. 48 hrs after that, increased dyspnea - need prn inhaler with sxs relief (had not needed inhaler for >6mo). 72 hrs after vaccine had blister on (R) hand only (single); + subjective fever started at 24 hrs.									Y	10/19/2007			None	MIL	MIL	Wellbutrin, Lisinopril	None (although wife had URI sxs)	None			1						1	Blister; Dyspnoea; Erythema; Pyrexia; Skin lesion	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~1080U~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0294307	10/24/2007	PA	16.0	16		F	10/23/2007	Pt became warm and dizzy. Had pt hut her head down on the table, applied ice to her neck. Pt passed out several seconds later, became stiff as I was holding her, then became limp for sev seconds before awakening. Had pt lay down with legs elevated for about 15 min.									Y	10/22/2007	10/22/2007	0		PVT	PVT						1						1	Dizziness; Hypotonia; Loss of consciousness; Musculoskeletal stiffness; Skin warm	FLU3~SANOFI PASTEUR~U2469AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1265U~2~IM~RA~HPV (GARDASIL)~1	USA		Influenza
0294308	10/24/2007	NM	1.1	1	.1	M	10/24/2007	chicken pox lesions -> vesicles with surrounding erythema present diffusely on trunk (anteriorly + posteriorly), groin and upper extremities				Y						10/12/2007	10/23/2007	11	None	PVT	UNK	None	None	Congenital Heart Disease-Transposition of great arteries			1						1	Blister; Erythema; Varicella	FLU3~SANOFI PASTEUR~UT2959CA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB211AA~1~UN~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0184U~1~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1246U~1~UN~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0294297	10/25/2007	NC	29.0	29		F	10/25/2007	Vaccine administered on 10/17/07. Patient had fever & chills on Thursday PM. States she went home and went to bed.  On Friday 10/19/07 was achey with fever & chills and stayed in bed all day.  Started feeling better Saturday PM.									Y	10/17/2007	10/18/2007	1	None	UNK	UNK		None	None			1						1	Chills; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79718~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0294395	10/25/2007	FL				M	10/22/2007	SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial information received on 16 October 2007 from a health care professional. An elderly, (age not specified), male patient had received an injection of influenza vaccine, manufacturer unknown, lot number unknown, and route and site of administration not provided; on an unspecified date in 2006. On hour post-vaccination, the patient developed generalized hives and since then has had chronic urticaria. The event required a doctor visit. Treatment included multiple unspecified antihistamines. Pre-existing medical history included a possible allergy to FluMist. It was unknown whether the patient was taking FluMist at the time of vaccination. Illness at the time of vaccination was unknown. At the time of this report, the patient had not recovered.				Y					N					UNK	UNK			The patient has a possible allergy to FluMist.		200703510	1						1	Urticaria; Urticaria chronic	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0294401	10/25/2007	TX	10.0	10		M	10/25/2007	Several lesions on arm and abdomen, under arm, no treatment									U	10/17/2007	10/24/2007	7	none	PVT	PVT	none	none	none			1						1	Skin lesion	FLU3~SANOFI PASTEUR~UT2473GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0494U~1~IM~LA~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~1177U~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0294402	10/25/2007	GA	27.0	27		F	10/25/2007	Patient received the influenza vaccine 10/23/07 in the afternoon. Had no problems until she woke up the next morning with erythematous rash to her axillae, trunk, abdomen, ears and right foot. Her right foot was swollen to the extent that her shoe had to be removed. She had no breathing difficulties and her vitals were BP 124/86 P 71 respiratory rate 18. Her only c/o was itching. She was sent toDr.'s office for evaluation and treatment. She was given a steroid injction, zyrtec and a medrol dose pack. She called in this morning (10/25/2007)to report that all of her symptoms were resolved except her Right foot which remains swollen and painful. She was instructed to start the medrol dose pack (Dr. told her to begin that today if her symptoms were not resolved.				Y					Y	10/23/2007	10/24/2007	1		UNK	UNK	vitamins	no	none			1						1	Oedema peripheral; Pain in extremity; Pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~u2469aa~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294403	10/25/2007	GA	75.0	75		M	10/25/2007	Client received flu shot and then went home and using the arm he received the shot in, washed 3 large trucks. By the next morning he had a large hematoma covering his upper arm.									Y	10/15/2007	10/16/2007	1		PUB	PUB						1						1	Haematoma	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80682~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0294404	10/25/2007	MO	26.0	26		M	10/25/2007	Pt reported significant fevers >102.5, myalgias/arthralgias, tender erythema left upper arm. Significant gastrointestinal symptoms.				Y					Y	10/18/2007	10/19/2007	1		PVT	PVT	AllegraD, Flonase, Albuterol	None	Perennial allergies, migraines, asthma			1						1	Arthralgia; Erythema; Gastrointestinal disorder; Myalgia; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~U2438AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294406	10/25/2007	PA	40.0	40		F	10/25/2007	Approximately one hour following vaccine administration patient developed  lightheadedness, clamy, sweating reaction, mild nausea no vomiting. symptoms completely resolved < 4 hours									Y	10/24/2007	10/24/2007	0		MIL	MIL						1						1	Cold sweat; Dizziness; Hyperhidrosis; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua300aa~6~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0294407	10/25/2007	NY	64.0	64		F	10/18/2007	Patient started getting extreme upset stomach, vomiting, diarrhea, fever and fatigue. Lasted 4 days. 11/27/07 Reviewed hospital medical records which reveal patient experienced a syncopal episode.  After having diffuse abdominal cramps & straining to have BM, got weak, dizzy & passed out.  Then had nausea, vomiting x 3 & diarrhea.  Admitted to ER on 10/12 & kept overnight for observation, d/c to home 10/13/2007. Cardiac consult done. FINAL DX: vasovagal syncope.				Y	Y	1			Y	10/12/2007	10/12/2007	0	LABS: CT of head.  EKG & CXR WNL.  H/H 11/3/34.7 (L), neutros 82% (H), monos 10% (H).BUN 26 (H). total bilirubin 0.1 (L).  Amylase 126 (H). Cholesterole 217 (H), LDL 145 (H)Troponin WNL.  Echocardiogram revealed imipaired relaxation pattern of LV diastolic filling; sclerotic aortic valve; normal EF; & mitral annular calcification.	UNK	UNK			PMH: polio, post polio syndrome, hypothyroidism, borderline HTN.  Allergic to penicillin & sulfa.			1						1	Diarrhoea; Fatigue; Pyrexia; Stomach discomfort; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFEUA274BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0294409	10/25/2007	TX	33.0	33		F	10/25/2007	injection given approx 2:25pm-at 3:15, pt went into resp distress, O2 sat 71, swelling to face and throat, SOB, eyes rolled back, pale, diaphoretic with blue lips 10/25/07-records received for DOS-10/20/07-DC DX: Anaphylaxis. Quadraplegia. UTI. Presented to ER with C/O shortness of breath. Developed immediate anaphylatic reaction after receipt of flu shot. Became cyanotic and hypotensive. Observed in ICU overnight.				Y	Y	1			Y	10/19/2007	10/19/2007	0	10/25/07-records received- CXR: heart is enlarged lung fields are clear. Labs WNL.	UNK	UNK	Neurontin, Baclofen, Zyrtec, oxybutynin chloride, famotidine, zanaflex, many PRN meds	none reported	non-healing surgical wound, quadraplegia, neurogenic bladder and bowel, NKDA 10/25/07-records received-HX: Quadraplegia.			1						1	Cyanosis; Dyspnoea; Gaze palsy; Hyperhidrosis; Oxygen saturation decreased; Pallor; Pharyngeal oedema; Respiratory distress; Swelling face	FLU3~SANOFI PASTEUR~u2464aa~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0294410	10/25/2007	PA	53.0	53		F	10/25/2007	eight hours after injection developed erythema and edema (5cm circular area) around injection site; also complained of headache for first 10 hours									Y	10/24/2007				MIL	PUB		None	Codiene			1						1	Headache; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~AFLUA3208A~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294411	10/25/2007	DC	53.0	53		F	10/25/2007	Hives and swelling of the airway-Given Benadryl and set to Primary Care Provider who gave her oral steroids.				Y					Y	10/16/2007	10/16/2007	0		UNK	PVT	unknown	none	none listed			1						1	Pharyngeal oedema; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79897~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0294416	10/25/2007	TX	1.08	1	.1	F	10/25/2007	7 days after vaccination a severe rash developed. Began at hairline and moved down over face and whole torso. Next day continued over arms, legs, hands, feet. Torso so completely covered in rash, there is little non-rash area - looks just like pictures of measles rash seen in books and online. Marin is listless, clingy, sleeping a lot, acts achy, slightly itchy on palms and neck. Ibuprofen given to make more comfortable. Went to doctor office on first day rash developed and told not to worry, that it would be better in a couple days and could be caused by MMR shot or another virus she happened to pick up.				Y					U	10/17/2007	10/24/2007	7		PUB	PVT		runny nose				1						1	Abnormal behaviour; Hypersomnia; Listless; Pain; Pruritus; Rash; Rash generalised; Rash morbilliform	FLUX~UNKNOWN MANUFACTURER~~1~UN~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HBHEPB~MERCK & CO. INC.~~3~UN~LL~HIB + HEP B (COMVAX)~1|MMR~UNKNOWN MANUFACTURER~~1~UN~LL~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0294421	10/25/2007	KY	47.0	47		F	10/25/2007	PT STATES HER ARM IS VERY SORE AND HAS A 2 AND 1/2 IN RAISED AREA AFTER RECEIVEING BOTH A FLU SHOT AND PNEUMONIA SHOT.  SHE IS ALSO COMPLAINGING OF A 103 DEGREEE FEVER										10/22/2007	10/22/2007	0		UNK	UNK						1						1	Pain in extremity; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U2499AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~09624~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294422	10/25/2007	ND	65.0	65		F	10/12/2007	Left upper arm redness, warmth, swelling from below shoulder to elbow.  Perimeters marked by hospital ER.  Lab work done at hospital.  Report by patient WBC elevated.  Received injection about 2:40 p.m., 1st symptoms occurred at 4:40p.m.  Treated self for 24 hours then received medical care at ER.  Received IV antibiotic and prescription for Clindomycin po 300 QID.  Diagnosis from physician as reported by patient was cellulitis.				Y					U	10/10/2007	10/10/2007	0	WBC, Blood Cultures, Hgb, Platelets as reported by patient.	UNK	UNK	Verapamil 240mg po daily, Lisinopril 20mg po daily	None	Multiple Sclerosis, Flagyl, Augmentum, Sulfa Drugs, Tetracycline, shellfish			1						1	Blood culture; Erythema; Oedema peripheral; Platelet count; Skin warm; White blood cell count increased	FLU3~SANOFI PASTEUR~U2439AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0697U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294423	10/25/2007	IN	36.0	36		F	10/25/2007	Rash Developed within 24-48 hours of vaccination and persisted for over 1 week. Patient seen in office 10/19/2007, and treated with Prednisone.									U	10/11/2007	10/13/2007	2	Exam - no labs	PVT	PVT	Zolort 50mg Daily, Prinzide 20-25mg, Mobic 7.5mg Daily	NO	NO			1						1	Rash	FLU3~SANOFI PASTEUR~U2464AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294425	10/25/2007	OK	2.0	2	.9	M	10/25/2007	Administered 0.5ml of Non-VFC flu vaccine to child under four years of age.  Mother had reported that child had had previous flu vaccines but no record available.  Contacted child's mother by telephone and she denied that child had any reactions to vaccine whatsoever.										10/23/2007			None	PUB	PUB	None	None	None	None~ ()~NULL~~In Patient		1						1	Inappropriate schedule of drug administration; Incorrect dose administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80433~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0294428	10/25/2007	IN	38.0	38		M	10/25/2007	erythema and induration at site of injection									Y	09/14/2007	09/14/2007	0		PUB	UNK		treated for etoh and pancreatitis	pancreatitis and alcoholism			1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~unknown~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~09934~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294431	10/25/2007	MD	51.0	51		F	10/25/2007	I was administered influenza vaccine by my colleague on 10/19/07 evening.  I proceeded to go to exercise class then.  On Saturday morning, I woke up with a headache and a neck ache.  I took aleve and the headache improved, but the neck ache persisted.  On 10/22/07, I woke up with a very stiff neck, much worse than Saturday.  No further exercise was done after the initial 10/19/07 class.									N	10/19/2007	10/20/2007	1	None	PUB	PVT	Lipitor and Buspar	No	No			1						1	Headache; Musculoskeletal stiffness; Neck pain	FLU3~SANOFI PASTEUR~u245laa~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294432	10/25/2007	PA	64.0	64		F	10/25/2007	Patient received vaccination in right arm 10/24/07 at 12 noon.  Next morning upper right arm was swollen and painful to move; swelling was anterior and superior to vaccination site.  No complaints of difficulty breathing, chest pain, nausea, vomiting, fever, joint pain or pain upon touchen swollen extremity.				Y					U	10/22/2007	10/23/2007	1	ED staff felt swelling was unrelated to flu vaccine and referred pt to ortopedist.	PUB	PVT		None	Breat cancer 1988; polio (childhood)			1						1	Oedema peripheral; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA296GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0294433	10/25/2007	OH	27.0	27		F	10/25/2007	9:18 received her flu vaccine.  She had received the flu vaccine 1 other time approx 3 years ago and got the flu from it but had no other reaction 10:05 returned to treatment suite stating she didn't feel right and that is had started about 10 minutes after her vaccine.  She complained of lightheadedness, chest tightness and was diaphoretic.  VS 98.5, 96, 132/92 O2 sat 100% 10:10 Dr.  back to assess and ordered Tylenol 650mg & Benadryl 25 mg, they were administered. 10:15 Continues to c/o chest tightness (rated 10/10), dizziness and was pale, rechecked O2 sat and was 90%, loosing connection but possibly dropped to 75%.  02 applied at 2L. 10:22 O2 sat increased to 100%.  Dr. back to assess ordered PIV and continue to monitor which was started in left AC with NS free flowing.  Pt continues to c/o chest tightness/pressure (now 7/10). 10:30 Stated feels little better but chest pressure continues at 7/10.  O2 sat 100%.  Dr. ordered wait 30 minutes and if she is back to normal she may return to work. 10:40 02 removed, sats 100% 10:45  c/o dizziness.  BP 128/80 Pulse 80 per Dr. probably rx to Benadryl. 11:00  states chest tightness continues at 7/10 and not improving also now has nausea, O2 sat 100%  BP 122/85 P 77 Resp 16 11:15 10mg ordered by Dr. and administered.  Per Dr. patient to go home when no longer short of breath, to take Claritin or Benadryl for next 2-3 days and see primary MD for any further complications. 11:25 Chest pressure decreasing 11:30 Family called.  Father came to pick her up and informed of situation.  She returned to work the next day with no further complications.									Y	10/24/2007	10/24/2007	0		UNK	UNK	Clindimycin, Birth control, Vicoden, Ibuprofen	None	Allergies: Penicillian, Sulfa, Erythomycin, Imitrex, TB			1						1	Chest discomfort; Dizziness; Hyperhidrosis; Nausea; Oxygen saturation decreased; Oxygen supplementation; Pallor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA043AA~2~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0294434	10/25/2007	IL	35.0	35		F	10/25/2007	Received vaccine 10/22/2007@2:30pm. At 5:30pm had rash on arms legs and tops of feet. None on torso. Pt took Benadryl at home. Morning of 10/23/2007 pt still had rash and red cheeks. Physician at her work place gave Zantac and Loratidine. Wed AM 10/24/2007 pt had joint pain in wrists, elbows, knees and ankles.  Hands and ankles were swollen. Pt saw private physician and was given injection of Kenalog. Thurs 10/25/2007 after tx at Dr. office pt sx almost completely resolved.				Y					Y	10/22/2007	10/22/2007	0		UNK	UNK	None	None	Allergy to Strawberries and Raspberries			1						1	Arthralgia; Flushing; Joint swelling; Oedema peripheral; Rash	FLU3~SANOFI PASTEUR~U2438AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294435	10/25/2007	NC	11.0	11		M	10/25/2007	PT SEEN IN OFFICE ON 10/25/2007 FOR POSSIBLE VACCINE REACTION. PT RECEIVED TDAP AND VARIVAX ON TUESDAY, 10/23/07. ON 10/25/07 PT PRESENTED WITH LEFT ARM SWOLLEN, RED, AND SLIGHTLY ITCHY. PROVIDER NOTED THAT LEFT UPPER ARM WAS RED, INDURATED, AND WARM, AFFECTED AREA 3 X 4 CM, NONTENDER TO TOUCH. PT WAS ADVISED TO USE COOL COMPRESSES PRN AND HYDROCORTISONE CREAM PRN ITCHING. TO CALL BACK FOR INCREASED REDNESS, PAIN, OR SWELLING.				Y					U	10/23/2007	10/23/2007	0	NONE	PVT	PUB	SINGULAIR, NASONEX, ADVAIR, ALBUTEROL INHALER PRN	NONE	ECZEMA, KERATOSIS PILARIS, ALLERGIC RHINITIS, REACTIVE AIRWAY DISEASE			1						1	Erythema; Induration; Oedema peripheral; Pruritus; Skin warm	FLUN3~MEDIMMUNE VACCINES, INC.~500486P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B006AA~1~IM~LA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1178U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0294437	10/25/2007	WY	9.0	9		F	10/23/2007	Fainted and fell from chair hitting face on floor causing abrasions. Showed seizure like activity. Was incontinent of urine. Pale color. Paramedics called. Oxygen and IV started. Transported to  Hospital.				Y					Y	10/19/2007	10/19/2007	0	CAT scan	UNK	UNK	Zyrtec prn allergies	none	seasonal allergies			1						1	Computerised tomogram; Convulsion; Excoriation; Face injury; Fall; Oxygen supplementation; Pallor; Syncope; Urinary incontinence	FLU3~SANOFI PASTEUR~u2490aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294440	10/25/2007	WA	80.0	80		F	10/25/2007	pt returned to the pharmacy within a week of receiving the influenza vaccination. she complained of heavy bruising, yellowing of the skin, and pain/tenderness near the injection site.  pt mentioned she is taking OTC pain killers to treat it.									Y	09/27/2007	09/28/2007	1		UNK	PUB	paroxetine, conjugated estrogen, clonidine, doxycycline	N/A	none known	heavy bruising, yellowing of the skin, pain/tenderness~Influenza (Seasonal) (Fluzone)~1~80.90~In Patient		1						1	Contusion; Pain; Tenderness; Yellow skin	FLU3~SANOFI PASTEUR~U2453AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294441	10/25/2007	MI	53.0	53		F	10/25/2007	Client developed large red blotches/raised red welts on back, waist, arms, and neck the evening after flu vaccine was given.  Client also received a PPD Mantoux skin test (left forearm, Lot C2678AA), which was negative, 0 mm at 72 hours. She was taken to the emergency room at 8:30 pm that evening.  No fever, no change in usual blood pressure, no itching, no temperature elevation, no change in behavior of client.  In ER, client received an injection of diphendramine x 1,  and Zantac.  Prescribed oral prednisone qd x 7 days, Zantac bid x 7 days, and loratadine 10 mg qd x 7 days.  Client has finished with prednisone and loratadine today, and has last dose of Zantac this evening.  The client was noted to be back to normal the next morning.  Client has had flu shots in the past with no problems. Client has profound mental retardation due to PKU.  She has a public guardian.				Y					Y	10/18/2007	10/18/2007	0		PUB	PVT	HCTZ, MVI, Provera x 14 days each month	none	profound mental retardation due to PKU; allergic to PCN, tetracycline, cephalasporins, sulfa, betalactins			1						1	Erythema; No reaction on previous exposure to drug; Rash macular; Urticaria	FLU3~SANOFI PASTEUR~U2488AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294442	10/25/2007	LA	68.0	68		F	10/25/2007	SEVERE SWELLING ENTIRE LEFT ARM & BREAST.  REDNESS IN SAME AREA. NAUSEA UPSET STOMACH LASTING 4 DAYS...ARM STILL TENDER TILL NOW.				Y						10/06/2007	10/06/2007	0		UNK	UNK	LEXAPRO GEMFIBROZIL HZTZ	NONE	NONE			1						1	Breast swelling; Erythema; Nausea; Oedema peripheral; Stomach discomfort; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0294444	10/25/2007	MN	61.0	61		M	10/25/2007	That same evening as the shot, I began having having flu-like symptoms between 8:15 and 8:30. First was slight headache, then chills/shakes, then 102 temperature - generally miserable. I went to bed about midnight but I was so restless I went into another room to sleep. Then about 3:00 AM, it all broke, and I felt normal - just fine. I have had a shot every year for at least 20 years, but have never had any other negative reaction except in 1990 when I had a similar rection and outcome. I always thought this may happen with a live virus shot, but not with the dead virus. Am I wrong?									Y	10/24/2007	10/24/2007	0		UNK	UNK		none	none			1						1	Body temperature increased; Chills; Headache; Influenza like illness; Restlessness; Sleep disorder; Tremor	FLU3~SANOFI PASTEUR~#U2466AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294454	10/25/2007	VA	25.0	25		F	10/24/2007	(L) deltoid warm to touch, painful. 2 3/4x4 erythema and induration. Patient took Tylenol 325 mg po once that evening. After showing to LPN - advised to ice, continue monitoring and Tylenol PRN.									Y	10/17/2007	10/17/2007	0	N/A	UNK	UNK	Advair Diskus; Albuterol; Valtrex	None	B-Asthma			1						1	Erythema; Induration; Pain in extremity; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA319AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0294455	10/25/2007	NY	21.0	21		F	10/23/2007	Itching, sore throat, shot site swollen and warm to touch pain when moving arm. Given a sling and pain medication told to apply warm compress.				Y					Y	10/19/2007	10/20/2007	1		PVT	OTH		None				1						1	Injection site pain; Injection site swelling; Injection site warmth; Pharyngolaryngeal pain; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA296KA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0294457	10/25/2007	NM	50.0	50		U	10/25/2007	Headache, upset stomach, diarrhea, general malaise within 5 days of shot.									Y	10/09/2007	10/14/2007	5	N/A	PUB	PVT		None	None			1						1	Diarrhoea; Headache; Malaise; Stomach discomfort	FLU3~SANOFI PASTEUR~U2489AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294460	10/25/2007	OR	70.0	70		F	10/25/2007	Swelling at site with redness and heat; flu like symptoms.									Y	10/17/2007	10/18/2007	1		PVT	OTH						1						1	Influenza like illness; Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2488AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294461	10/25/2007	TX	68.0	68		F	10/25/2007	After 7 1/2 hours started dizziness-Less than 5 minutes.										10/24/2007	10/24/2007	0		UNK	UNK	Maxide-Synthroid-Fosamax					1						1	Dizziness	FLU3~SANOFI PASTEUR~U2510AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294462	10/25/2007	NV	30.0	30		F	10/25/2007	Pt reports 24 hours after shot she had pain and weakness so severe in right arm that she went to Urgent Care. They gave her a sling, 800 mg Motrin, a pain shot. 48 hours after PPV 23, she went to a different Urgent Care with a temp of 102. Arm was now swollen and hot. They changed her antibiotic to Cipro. 4 days after injection, 1 week later she has full use of arm, no sling use, slight swelling, redness and heat in right arm.				Y					Y	10/18/2007	10/19/2007	1		PUB	PUB	Augmentin	Sinus infection				1						1	Asthenia; Erythema; Oedema peripheral; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~U2494AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0881F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294463	10/25/2007	NC	3.0			U		Local erythema - 3 cm, with large area of swelling surrounding. Recommended ice compresses; Benadryl									U				None	PVT	UNK		None				1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2527AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294466	10/25/2007	MS	4.0	4		F	10/24/2007	1 day after immunizations pt. c/o increased temp 103 and swelling @ face-no trouble breathing.									Y	10/17/2007	10/18/2007	1		PVT	PUB		No	Asthma			1						1	Body temperature increased; Swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B046AA~5~UN~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2438AA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0110~4~UN~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0428U~3~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0294467	10/25/2007	TX	50.0	50		F	10/23/2007	pruritus, edema, & erythema in hands & knees beginning night of vaccine and continuing throughout the next day-did not reside with Claritin or Benadryl MD visit needed										10/22/2007	10/22/2007	0		OTH	PVT	Chantix, Bupropion SR					1						1	Erythema; Oedema; Pruritus	FLU3~SANOFI PASTEUR~U2510AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294472	10/25/2007	CA	53.0	53		F	10/24/2007	On 10/23/07. Pt c/o feeling tired 1-2 hrs after vaccination, congestion on L basal/side of face and tongue swelling. Felt some words were slurred and speech thick. (not observed today). Her injection site was sore-no redness or induration or swelling. no rashes. no wheezing.				Y					Y	10/23/2007	10/23/2007	0		PUB	OTH	Diovan, Avandamet, Cardiazem, ASA		HTN, DM			1						1	Dysarthria; Fatigue; Injection site pain; Nasal congestion; Speech disorder; Swelling face; Swollen tongue	FLU3~SANOFI PASTEUR~U2453AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294473	10/25/2007	WV	54.0	54		F	10/25/2007	Got vax 10/22-After 20 minutes developed episode of anaphylaxis, hoarseness, sweating, headache, and stomach cramps. Patient took Benadryl										10/22/2007	10/22/2007	0		UNK	PUB	None	None	None			1						1	Abdominal pain upper; Anaphylactic reaction; Dysphonia; Headache; Hyperhidrosis	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0294474	10/25/2007	AZ	61.0	61		F		Pain in (L) arm with localized redness and inflammation evident 2 days post inoculation. Pt states that although her arm is still very uncomfortable to use, it seems to be resolving on its own.									N	10/18/2007	10/18/2007	0	N/A	OTH	PUB	Unk	N/A	None			1						1	Erythema; Inflammation; Pain in extremity	FLU3~SANOFI PASTEUR~U2498AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0961U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294475	10/25/2007	PA	39.0	39		F	10/22/2007	hives/urticarial w/in 15 minutes ER within 1 hr throat weird sensation tongue thick AL Alavert 10 mg 3 Epinephrine Rx Medrol dose pk IV fluids IV steroid Pepcid				Y					Y	10/19/2007	10/19/2007	0	None	PVT	UNK				hives~Hep B (no brand name)~2~34.00~In Patient		1						1	Throat irritation; Tongue disorder; Urticaria	FLU3~SANOFI PASTEUR~U2491AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294476	10/25/2007	CT	69.0	69		F	12/22/2007	1. flu shot approx 11:30-12 noon (Thursday) 2. Had Egg Salad Sandwich for lunch-same day 3. 8-9 pm same day started with itchy back 4. Next day rash spread to front of trunk (upper chest) 5. Sat. rash covers back, front of trunk and arms, sees MD who presc. Methylprednisolone taper for 7 days and Benadryl 25 mg tab. 6 per 24 hrs. did so for 2 days.				Y					Y	10/18/2007	10/18/2007	0	None	PUB	PVT	Lisinopril 20 mg one tablet QD, Simvastatin 40 mg one tablets QD (Zocor generic)	None	Admits to seasonal allergies Hypertension, increased cholesterol			1						1	Pruritus; Rash generalised	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294478	10/25/2007	NJ	3.0	3		F	10/19/2007	Erythema Multiforme 8 days after receiving Fluvax and Hep A brother also ill at the time with presumed 5th disease.									Y	09/26/2007	10/04/2007	8		PVT	UNK						1						1	Erythema multiforme; Sick relative	FLU3~SANOFI PASTEUR~U2446A~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB16BA~UNK~IM~RL~HEP A (HAVRIX)~1	USA		Influenza
0294479	10/25/2007	OR	43.0	43		F	10/18/2007	Patient given pediatric Hep B after consult with HD. Patient given adult Hep B vaccine approx 15 minutes after Peds dose. No adverse symptoms noted.									Y	10/18/2007	10/18/2007	0	None	PUB	PUB	None Known	No	None Known		OR200742	1						1	Incorrect dose administered; Overdose	FLU3~SANOFI PASTEUR~U2443AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB413AA~UNK~IM~LA~HEP B (ENGERIX-B)~1	USA		Influenza
0294480	10/25/2007	PA	61.0	61		F	10/18/2007	Aches, fever x 2 nights (101), nausea, diarrhea (never vomited).									U	10/14/2007	10/15/2007	1		PUB	PUB	None	None -  a cold, 6-7 days before	Penicillin, Codeine, Morphine allergy also Darvocet			1						1	Diarrhoea; Nausea; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA2820A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0294481	10/25/2007	NH	83.0	83		U		Extreme swelling shoulder to elbow, excruciating pain from shoulder down to hands excessive amount of aspirin taken of 3 days now swelling has receded, discomfort is tolerable.									Y	10/12/2007			10/12/2007	PUB	UNK						1						1	Discomfort; Oedema peripheral; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0294482	10/25/2007	IL	72.0	72		F	10/22/2007	Upper right arm was red and swollen. Treated by doctor and he thought it was allergic reaction. Treating with Benadryl and Cephalexin. Right arm is affected area.				Y					Y	10/18/2007	10/19/2007	1		OTH	OTH						1						1	Hypersensitivity; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294484	10/25/2007	VT	50.0	50		F	10/20/2007	Erythema Nodosum Syndrome at site of injection ((R) upper arm) ? if this due to shot.				Y					U	10/18/2007	10/19/2007	1	None	PVT	PVT	Advair; Lo/Ovral; Albuterol	None	Allergy: Pen.			1						1	Erythema nodosum; Injection site reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80682~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0698U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294486	10/25/2007	ID	53.0	53		F	10/18/2007	Severe swelling - pain at injection site. MD visit x 3 diagnosis cellulitis				Y					Y	10/13/2007	10/13/2007	0	cellulitis	OTH	OTH		None	PCN allergy			1						1	Cellulitis; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~42498AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0961U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294487	10/25/2007	MN	21.0	21		F	10/21/2007	Red swollen area, warm around area. No drainage.									U	10/19/2007	10/20/2007	1	None so far	PVT	PVT	Birth control	None	None			1						1	Erythema; Skin warm; Swelling	FLU3~SANOFI PASTEUR~U2463AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294488	10/25/2007	MS	25.0	25		F	10/19/2007	Swelling below injection site on left arm approximately 8cm x 6cm in diameter.									Y	10/19/2007	10/19/2007	0		PUB	OTH	Yaz	None	None			1						1	Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA303BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0294489	10/25/2007	MN	13.0	13		F	10/22/2007	10/21 Onset of generalized pruritic rash 36-40 hours after receiving Fluzone vaccine, + fatigue, mild abdominal pain, No fever, chills, myalgias, headache. Rx with OTC Claritin and Benadryl. 10/22 patient saw her primary PCP - diagnosed with hives by PCP - Rx with Zyrtec QD and Benadryl PRN HS Cod tepid both PRN no signs of anaphylaxis.				Y					N	10/19/2007	10/21/2007	2	None	PVT	OTH		Improving cough/cold past 2 weeks	NKDA patient on Zoloft, Celexa taper, and Ritalin LA (on meds for several months)			1						1	Abdominal pain; Fatigue; Rash pruritic; Urticaria	FLU3~SANOFI PASTEUR~U2502AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294447	10/26/2007	CA	3.0	3		F	10/26/2007	3 yo boy with history of cerebral palsy and seizure disorder, off seizure medications for 3 mos (phenobarbital, keppra) developed generalized pruritic salmon pink rash on face, neck, arms, axilla trunk, back one hour after administration of flu vaccine.  Some raised macules on face, blanching.  Rash resolving after administration of Benadryl.  No hemodynamic instability.				Y					Y	10/25/2007	10/25/2007	0	none	PVT	PVT	none	none	Cerebral palsy, mental rertardation, seizure disorder.  Latex allergy (uticaria).  No history of egg allergy.  No reaction to previous flu vaccine.			1						1	Pallor; Pruritus generalised; Rash; Rash macular	FLU3~SANOFI PASTEUR~U2220DB~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294448	10/26/2007	WA	28.0	28		F	10/26/2007	I felt fine until around seven hours after the injection and then suddenly felt very tired and dizzy.  The next morning I woke up and was still very tired, like I'd not slept in several days. (I had a full 8 hours of sleep that night.)  I drove to work. On the way to work, it seemed to worsen.  I began feeling more dizzy - almost like I was drunk. I wasn't short of breath, but my voice was scratchy.  I stopped at a stoplight and fell asleep for a few seconds and then jolted awake.  I felt like my heart was beating fast, but that sensation only lasted a little while.  My arm was hurting from my neck all the way down to my wrist.  It was sore to the touch and had jolting pain when I lifted my arm.  The rest of the day I seemed to feel gradually better.  By 3 in the afternoon (a little more than 24 hours after the injection), I just felt a bit tired, my arm was still really hurting, but I was no longer dizzy. I did develop a cough later on in the day which lasted another 24 hours and then went away. I feel normal now.  The injection site is slightly tender, but no other symptoms.									Y	10/21/2007	10/21/2007	0	N/A	PUB	PVT	Ortho tricyclin	None	Allergy to Sulfa.			1						1	Cough; Dizziness; Dysphonia; Fatigue; Heart rate increased; Hyperaesthesia; Injection site pain; Pain in extremity; Somnambulism	FLU3~SANOFI PASTEUR~u2491AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294507	10/26/2007	NE	74.0	74		F	10/26/2007	Per patient's son, right arm was swollen, red, and hot.  Swelling started on the tricep and worked its way to the bicep.  Her physician prescribed a steroid.  She also took Benadryl.				Y					U	10/12/2007	10/13/2007	1		UNK	PVT						1						1	Erythema; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U2514AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964O~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294508	10/26/2007	NJ	64.0	64		F	10/26/2007	2 large raised, red, tender and painful areas on right upper arm. first noticed about 30 hours after injection. self  treated with ibuprofen and benadryl oral and topical										10/24/2007	10/25/2007	1		UNK	PVT						1						1	Erythema; Pain; Swelling; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0294510	10/26/2007	FL	52.0	52		F	10/26/2007	Employee's R arm began aching a couple of days(10/12)after receiving (10/9)the influenza vaccine. Thought pain would disapate but instead R shoulder became involved. Seen in Office 10/25 with mild swelling anterior medial aspect of rt shoulder and limited ROM.									U	10/09/2007	10/12/2007	3		UNK	PVT	none	none	Spleenectomy 2003			1						1	Injected limb mobility decreased; Musculoskeletal pain; Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79489~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0294512	10/26/2007	TX	78.0	78		F	10/26/2007	Patient received flu and penumonia vaccine on 10/24/07, she called her son at 6am on 10/25/07 and complained of itching, son saw her at 8:30am noticed rash on her arm and torso and upper leg. Her son gave her topical hydrocortisone cream and 1 dose of benadryl capsule 25mg. Patient stated having the flu shot given before with no problems.				Y					Y	10/24/2007	10/25/2007	1		PVT	PVT	Amiodarone 200mg 1 QAM; Atenolol 25mg 1 QAM; Calcium supplement; Fish oil supplement; Furosemide 40mg 1 QPM; Levothyroxine 0.175mg 1 QAM; Lantus 20 units QAM; Lomotil PRN; Tylenol Extra Strength PRN; Vytorin 10/80mg 1 QHS; Zoloft 100mg 1 QH	None	Hypertension, Hypercholesteremia, Diabetes Type II, Hypothyroidsim, Atrial Fibrillation			1						1	No reaction on previous exposure to drug; Pruritus; Rash	FLU3~SANOFI PASTEUR~U2437AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1345U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294513	10/26/2007	MO	18.0	18		F	10/26/2007	After receiving the Flu vaccine on 10/25/07 at approximately noon, client felt unusually fatigued for the rest of the day. Upon waking, she felt 'like there was a 20 lb weight on her chest and increased swelling in throat and felt some difficulty breathing. Physical exam did not reveal any worrisome issues. recommended that she take diphenhydramine 50 mg QID prn swelling, sense of difficulty breathing. Reviewed emergency care available in area if needed later during weekend.									Y	10/25/2007	10/25/2007	0	none	PVT	PVT	Astelin nasal spray, Singular tabs, allegra tabs, flonase, 1adaywmone, vitamin e, vitaminc, calcium, glucosamine	seasonal allergies, chronic daily headaches	Chronic daily headaches and seasonal allergies			1						1	Chest discomfort; Dyspnoea; Fatigue; Pharyngeal oedema	FLU3~SANOFI PASTEUR~U2450AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294514	10/26/2007	TN	64.0	64		F	10/26/2007	Fever of 100.9 F, aches all over (like flu symptoms) on evening of vaccination. This continued for 24 hours. On 2nd day post-vaccination, had a knot in muscle of administration with localized, non-pruritic rash of red, splotchy areas with muscle tenderness/soreness.									Y	10/22/2007	10/22/2007	0	none	UNK	PVT	Maxzide 37.5/25mg levothyroxine 0.025mg  Lexapro 10mg  Prevacid 30mg  MVI  Calcium/Vit d 600mg KCl supplement	none	Menier's Disease  enlarged spleen w/low wbc count  hypothyroidism  GERD  osteoporosis  depression			1						1	Influenza; Injection site mass; Muscle swelling; Myalgia; Pain; Pyrexia; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA031AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0990u~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294515	10/26/2007	MI	50.0	50		F	10/26/2007	Employee received influenza vaccination on 10/22/07 at approx. 9:30 am and at approx. 6:15 pm the employee started to not feel well, dizziness, warm and developed a headache, Leg/feet cramps bilateral lasting a few minutes two times that evening(per employee toes curled), approx 10:00 pm employee states fever of 103 F.  Employee went to sleep, woke up aprox 1:00 am soaking wet, no fever. Headache remained.  Employee called department manager next am to call in sick for work, employee still had headache, planned on coming in later in afternoon.  Dept Mgr called this nurse and reported incident. This nurse called employee, employee stated I'm doing better nowHeadache remained, no fever, no dizziness, no return of leg/toe cramps.  Employee instructed if symptoms persist or return of fever, or new symtoms to call this nurse or ER as needed. Emp. reported to work 10/23 at 1:00 pm with mild headache, no other symptoms.  Aprox. 8:15 pm on 10/23 employee stated I felt back to normal.  10/24 Emp. reported no further problems.									Y	10/22/2007	10/22/2007	0	N/A	PVT	PVT	None	None stated	None	None~ ()~NULL~~In Patient		1						1	Dizziness; Headache; Malaise; Muscle spasms; Pyrexia	FLU3~SANOFI PASTEUR~U2465AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294517	10/26/2007	NC	5.0	5		M	10/26/2007	VARICELLA AND FLU VACCINE GIVEN ON 10/22/07 LEFT ARM.  PATIENT RETURN TO CLINIC ON 10/24/2007.  HE SAW DR.  PRESENTED WITH LEFT ARM SWOLLEN AND RED FROM ELBOW TO SHOULDER AND WARM TO TOUCH.  PER DR. BENADRYL WAS ADMINITERED PO 25 MG.				Y					Y	10/22/2007	10/23/2007	1	NONE	UNK	UNK						1						1	Erythema; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U2457DA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1331U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0294519	10/26/2007	FL	26.0	23		F	10/26/2007	2-3 hours after vaccination, pt had extreme headache, pain and redness at the sight.  Later developed respiratory difficulty, controlled by use of pro-air inhaler.  Next morning pt's headache remained and had large local reaction at the site of the injection.  Pt called the office and came in for an evalution.									Y	10/25/2007	10/25/2007	0	None	UNK	PVT	prilosec 20mg, clarinex 5mg, yaz birth control, allegra 180mg prn, topomax 75mg, imitrex 100mg prn, symbicort inhaler, pro-air inhaler prn	none	Sulfa, Cephlosporins, thymarisol, latex, floroquiones, singular			1						1	Dyspnoea; Headache; Injection site erythema; Injection site pain; Injection site reaction	FLU3~SANOFI PASTEUR~UT244BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294522	10/26/2007	NH	48.0	48		M	10/26/2007	Pt states he received flu shot at approx. 10:00 a.m. today (10/26/07).  Started having mild nausea and lightheadedness/dizziness at approx. 12:15 p.m.  Was advised dizziness was considered a severe reaction and was advised to be seen at Emergency Room.  Pt states he was not going to go to the Emergency Room; that he was instead going to go play golf and would seek medical attention if symptoms worsened or persisted to 10/27/07.									U	10/26/2007	10/26/2007	0	None at this time.	PVT	UNK			No known allergies			1						1	Dizziness; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0294523	10/26/2007	MD	58.0	58		F	10/26/2007	8 cm erythemic, ecchymotic area of induration at the injection site and same sided neck pain (right).									U	10/24/2007	10/25/2007	1	None	PUB	PVT	Plavix, Zetia, Metapropolol, Nexium, Naprosyn, ASA, Lisinopril	No	Allergy to Sulfa			1						1	Injection site erythema; Injection site haemorrhage; Injection site induration; Neck pain	FLU3~SANOFI PASTEUR~u2478ba~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294525	10/26/2007	CT	32.0	32		F	10/26/2007	First time individual received a flu shot. 1 hour after immunization felt as though she was having trouble swallowing, tried to ignore it.  4 hours after flu shot reports to this facility that she is having trouble breathing.  Resp rapid and shallow, pulse rapid. Given Benadryl 50 mg IM and Epinephrine 1:1000 0.3 mg SC with no change in symptoms until ambulance arrival. Transported to ER. Was told that she had an allergic reaction and if she had reported it sooner the Benadryl probably would have taken care of it.  Put on Prednisone and given an epi pen for emergency use.  Advised to see an allergist to determine actual cause of allergic reaction. Warned that the next exposure could cause a more rapid and more severe reaction.				Y					Y	10/25/2007	10/25/2007	0	PSO2 95 to 100% at this site. Unknown hospital testing, if any.	UNK	PVT	Nortriptyline	Irritable Bowel Syndrome (IBS)	IBS  no known allergies			1						1	Dysphagia; Dyspnoea; Heart rate increased; Hypersensitivity; Respiratory rate increased; Similar reaction on previous exposure to drug	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA031AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0294526	10/26/2007	UT	45.0	45		M	10/26/2007	Systemic reaction with fever, chills, myalgias, and arthralgias with local inflammation and induration and erythema.  Began the day after injection and continued for two days				Y					Y	10/23/2007	10/24/2007	1		PVT	PVT		none	Lymphoma			1						1	Arthralgia; Chills; Erythema; Induration; Inflammation; Local reaction; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U25122AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0989U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294527	10/26/2007	CT	56.0	56		F	10/26/2007	35 minutes after receiving flu vaccine started to feel weak, as though legs were giving out on her. Gait unsteady, felt as though she couldn't control her legs. Pupils = and react to light; hand grip strength strong and =; foot strength =; pinprick sensation = on feet. Rested 20 min - felt better, no symptoms apparent, returned to work.									Y	10/23/2007	10/23/2007	0	Vital signs wnl.  Fingerstick blood sugar 153 (had just eaten and apple and granola bar.)	UNK	PVT	Lexapro, Xanax, Hormone Replacement Therapy		depression, anxiety			1						1	Asthenia; Blood glucose abnormal; Gait disturbance	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA031AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0294577	10/26/2007	CO	1.5	1	.6	F	10/26/2007	Fever of 101 - 103 starting 4 days after vaccination.  Loss of appetite, fatigue, and chills so far lasting 3 days and on going.  The only treatment is Tylenon and Motrin.				Y					N	10/18/2007	10/24/2007	6		PVT	PVT		None	None			1						1	Anorexia; Chills; Fatigue; Pyrexia	FLUX~UNKNOWN MANUFACTURER~12345~3~UN~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0294578	10/26/2007	GA	11.0	11		F	10/26/2007	vaccine administered to child was not licensed for this age.									Y	10/25/2007				PUB	PVT		none known	none known			1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA274BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1|VARCEL~MERCK & CO. INC.~1102U~UNK~SC~~VARICELLA (VARIVAX)~1	USA		Influenza
0294579	10/26/2007	GA	9.0	7		F	10/26/2007	vaccine given was not licensed for this age group									Y	10/25/2007				PUB	PVT	none known	none known	none known			1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA274BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|VARCEL~MERCK & CO. INC.~1102U~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0294580	10/26/2007	GA	11.0	11		M	10/26/2007	vaccine given was not licensed for this age group									Y	10/25/2007				PUB	PVT	none known	none known	none known			1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA274BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0294581	10/26/2007	GA	9.0	9		M	10/26/2007	vaccine given was not licensed for this age group.									Y	10/24/2007				PUB	PVT	nonw known	none known	none known			1						1	Inappropriate schedule of drug administration; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA274BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0294582	10/26/2007	GA	15.0	15		F	10/26/2007	vaccine given was not licensed for this age group									Y	10/24/2007				PUB	PVT	none known	none known	none known			1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA274BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0294583	10/26/2007	GA	43.0	43		F	10/26/2007	Chest tightness, throat swelling,fluid around the neck area.				Y					Y	10/24/2007	10/24/2007	0		UNK	PVT		none	penicillin,codiene,bactrim			1						1	Chest discomfort; Fluid retention; Pharyngeal oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0294584	10/26/2007	VA	58.0	58		F	10/26/2007	about 8 hr post-vaccine, awakened with severe headache, nausea, muscle pain & pain at injection site; took Naproxen (2) & 2.5 mg Zomig for relief of headache.  1 am - Naproxen repeated; headache continued for 3 days.									Y	10/24/2007	10/25/2007	1		PUB	PUB	N/A	N/A	Bactrim		VA07:018	1						1	Headache; Injection site pain; Myalgia; Nausea	FLU3~SANOFI PASTEUR~U2440AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294585	10/26/2007	IL	5.0	5		F	10/26/2007	24 hours after receiving DTaP, IPV, MMR, Hep A and Influenza patient experience lip and left upper extremity swelling.				Y					Y	10/23/2007	10/24/2007	1		PVT	UNK						1						1	Lip swelling; Oedema peripheral	DTAP~SANOFI PASTEUR~C2628AA~5~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2461BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0324~5~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0527U~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0294586	10/26/2007	NY	4.0	4		M	10/26/2007	Presented to ER with Urticaria 24 hours after administration of:Influenza ; Dtap; IPV				Y					Y	10/22/2007	10/23/2007	1	None	PVT	PUB	Robitussin	URI	No			1						1	Urticaria	DTAP~SANOFI PASTEUR~U2289BA~5~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2490AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~UNKNOWN MANUFACTURER~Z1069~4~IM~RA~POLIO VIRUS, INACT. (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0294587	10/26/2007	WA	46.0	46		F	10/26/2007	Tingling sensations hands,palms.,Flush face, itching neck area				Y					Y	10/16/2007	10/16/2007	0	iv STARTED IN ER GIVEN MEDS AND OBSERVED FOR 4 HOURS .	MIL	MIL						1						1	Flushing; Paraesthesia; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA063AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0294589	10/26/2007	PA	28.0	28		F	10/26/2007	Patient experienced cellulitis in the left arm injected with both the flu and pneumonia vaccines				Y					Y	10/17/2007	10/18/2007	1		PUB	UNK						1						1	Cellulitis	FLU3~SANOFI PASTEUR~U2507AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0989U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294590	10/26/2007	OH	53.0	53		M	10/26/2007	I contracted guillian barre syndrome from a flu shot administered at work. I spent a month in the hospital being treated and rehabing. I then die 6 months of outpatient renhab and I am now receiving disability.  11/6/07 Reviewed hospital medical records which reveal patient experienced progressive numbness & weakness of all extremities x 4 days beginning 3 days s/p vaccine. Progressed to where patient could not even stand or walk.  Admitted to ER 11/15/2006 & transferred to higher level of care same day.  Exam revealed reduced reflexes.  Neuro consult obtained & LP done.  Records requested from transfer hospital. ER Dx: Guillain Barre syndrome. 12/7/07 Reviewed hospital medical records from transfer hospital which reveal patient experienced diarrhea, progressive weakness, aching & tingling, unsteady gait & trouble w/motor control of hands since 11/12/2006.  Admitted 11/16-11/21/2006.  Pulmonary consult done.  Tx w/IVIG x 5 doses.  Improved & transferred to rehab facility. FINAL DX: Guillian Barre syndrome. Per 60 day follow up: My hands have diminished strength and I must wear braces & crutches in order to walk now. I could not return to work and I new receive social security disability benefits & long term term disability from work. I have not had any health insurance since June 1, 2007 and will not be qualified for Medicare until June of 2009. This makes it very difficult to get any continuing health care. 1/13/2010 I still have weakness in my hands and need braces in order to walk.			Y	Y	Y	30		Y	N	11/08/2006	11/11/2006	3	LABS in ER: EKG WNL.  Spine x-ray & Brain MRI WNL. CSF showed RBC 1252, WBC 36, segs 13, lymphs 61, protein 85 (H) & glucose 55 WNL. LABS in hospital:MRI of spine WNL.  EMG c/w demyelinating disease.  LP from outlying hospital as above.  Chest CT revealed bilateral ground glass nodules indicative of possible mets.  CT of abdomen malignancy screening pending.	UNK	UNK	Toprol,lipitor	none	heart surgery PMH: CAD, MI, CABG x 5, 2/2006, HTN, hyperlipidemia			1						1	Blood product transfusion; CSF glucose normal; CSF lymphocyte count normal; CSF neutrophil count decreased; Grip strength decreased; Guillain-Barre syndrome; Impaired work ability; Lumbar puncture; Muscular weakness; Nuclear magnetic resonance imaging brain normal; Nuclear magnetic resonance imaging normal; Pain; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~unknown~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0294591	10/26/2007	MD	38.0	38		F	10/26/2007	I was given the Flu vaccine on 10/15/07. Since that time I have this horrible pain in my shoulder, back and down my arm. I've never had this kind of pain before with the flu vaccine. The nurse at this practice gave the injection very high up on the shoulder area. My arm hurts and I can't lift it above my head. It hurts a lot at night. I can't pull up the blankets on my bed at night. I think it is tendonitis. Is it common to give it so high up?? I believe this is an administraion error. When will this go away?? It may involve the nerves as well because I feel a sharp pain down my arm to the elbow area. The pain started as soon as I got the vaccinaton and got worse over a few days. It still hurts. My shoulder, upper back, arm are still hurting from this flu shot. You can contact the doctor for specifics like the lot number, etc.				Y					N	10/15/2007	10/15/2007	0	none	PVT	UNK	none	none	none			1						1	Back pain; Injected limb mobility decreased; Medication error; Musculoskeletal pain; Neuralgia; Pain in extremity; Tendonitis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0294592	10/26/2007	WA	64.0	64		M	10/26/2007	Redness, pain, swelling and hot to touch at site of pneumo injection. Reaction began within hour of injection. Swelling and redness spread later that night and the next day. Patient used ice to help with symptoms. Spoke with patient today, pain is gone but still has redness and swelling in the area.									Y	10/23/2007	10/23/2007	0		UNK	PVT	Diovan, Levoxyl, Digoxin, Warfarin, Pravachol, Coreg, Omeprarol, Metformin, Tikosyn					1						1	Erythema; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Swelling	FLU3~SANOFI PASTEUR~U2453AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294538	10/27/2007	WA	42.0	42		F	10/26/2007	This case was reported by a consumer and described the occurrence of injection site soreness in a 42-year-old female subject who was vaccinated with Fluarix (GlaxoSmithKline) for prophylaxis. A physician or other healthcare professional has not verified this report. Concurrent medications included Ibuprofen. On 8 October 2007 at 09:30 the subject received unspecified dose of Fluarix (.5 ml, unknown, left arm) On 8 October 2007, less than one day after vaccination with Fluarix, the subject experienced injection site soreness. She also reported that she was not able to raise her arm over her head. The consumer reported that she consulted a healthcare professional regarding the event. Medical attention was not required. The reporter noted that the events went away for a few days but returned. The reporter also questioned if there were other reports involving this lot number. The consumer considered that the events were disabling. At the time of reporting the event was unresolved.								Y	N	10/08/2007	10/08/2007	0	UNK	OTH	OTH	Ibuprofen	Unknown	Medical history: The subject reported that she had previously received influenza vaccinations and no reactions had been experienced. No adverse events had been experienced following other previous vaccinations.		A0690113A	1						1	Hypokinesia; Injected limb mobility decreased; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA298A8~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Disabling	Influenza
0294549	10/27/2007	NY	1.3	1	.3	M	10/23/2007	Boy born healthy. Pediatrician kept saying beautiful, big, fat healthy baby boy. Ate everything, playful, attended Nursery, swimming and other activities. Out of dozens of candidate to enrollment at a school, he was admitted having passed examinations and meeting with teachers and psychologists. Received various vaccinations. First flu, he reacted bad, We never knew. Government kept advertising Flu Campaign. He received the second Flu shot. He was like having received a short circuit. After 4 days, he was a different person. Lost eye-contact, ability to speak, stomach was ruined, he was lost, even body odor, breath, skin color, hair changed. After a nightmare of inquiries everywhere, he was found with High Level of Mercury poisoning. He started with Chelation and we are financially ruined but hope he will make it and defeat mercury poisoning a.k.a. Autism.  11/15/2007 MR received from PCP including multiple consultations.  Initial visit for 3 yr old check on 10/3/2004.  Noted were: delayed speech, not yet toilet trained. 4 yr WCC noting that speech is improving slowly and now toilet trained. Other evals report child reaching developmental milestones until age 2, when he lost some speech and no longer maintained eye contact.  Speech-Language eval for limited receptive-expressive language.  DXd with PDD in 11/2004. Neuro consult 9/2005 in agreement with above noting greater expressive language disorder than receptive.								Y	N	01/04/2003	01/04/2003	0	Absoluted Everything on file with us.  Labs and Diagnostics: Mineral testing of RBC elementswith lower Zinc and Molbydenum levels.	UNK	UNK			Never allergies. No alcohol or smoking. Extremely healthy wife. No history whatsoever of any medical or vice.			1						1	Autism; Breath odour; Chelation therapy; Emotional disorder; Metal poisoning; Skin discolouration; Skin odour abnormal; Speech disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0294550	10/27/2007	IA	24.0	24		F	10/26/2007	Throbbing arm, tingling finger advised to take Ibuprofen and ice arm and to call back if no better in 1-2 hours. Patient called next day because pain increased.									U	10/25/2007	10/25/2007	0		OTH	OTH						1						1	Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U2510AA~7+~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294551	10/27/2007	IL	42.0	42		F	10/24/2007	Approximately 5 minutes after vaccines, patient began to feel head and face get warm and just didn't feel right denied dyspnea, dizziness, nausea. Face and chest blotchy BP elevated; pulse 130 patient given 50mg PO Benadryl. Symptoms began to resolve. BP down and pulse decrease 90's. Skin warm and dry.									Y	10/24/2007	10/24/2007	0	None	PUB	PVT	Asmacort; Albuterol PRN	Asthma (chronic)	chronic asthma			1						1	Blood pressure increased; Dry skin; Heart rate increased; Rash macular; Skin warm	FLU3~SANOFI PASTEUR~U2457AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294552	10/27/2007	VA	65.0	65		F	10/26/2007	Patient received Pneumovax 10/25/07 - presented to clinic 10/26/07 with large area of erythema from mid right deltoid circling medially to mid posterior upper arm warmth, and edematous - started on Cephalexin 500mg PO BID x 7 to cover per MD. VS 97 - 82 - 18 140/80									U	10/25/2007	10/26/2007	1		OTH	UNK	LIPITOR 10mg; LISINOPRIL 10mg; PREMARIN 0.65mg	None	None			1						1	Erythema; Oedema peripheral; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79895~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0200U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294553	10/27/2007	UT	50.0	50		F	10/26/2007	Head ache, nausea, extreme pain in arm and shoulder, redness on arm and shoulder, hear from arm sore to touch next day (10-7-07) stiffness in arm pain to move seen doctor - on 10/17/2007 meds. Prednisone and Hydrocodone/Apap				Y						10/16/2007	10/16/2007	0	Seen doctor at healthcare on 10/17/07	OTH	PVT						1						1	Erythema; Headache; Musculoskeletal stiffness; Nausea; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294554	10/27/2007	CA	1.2	1	.2	M	10/26/2007	Patient presented into office on 10/24/07 with fever and rash									N	10/22/2007	10/24/2007	2	None	PVT	PUB		None				1						1	Pyrexia; Rash	FLU3~SANOFI PASTEUR~U2497AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0289U~1~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0294555	10/27/2007	WA	65.0	65		F	10/22/2007	Patient went to ER on Oct 14/07. Injection site she had turned red, swelled, painful. Doctor assessed as cellulitis, gave Bactrim DS and Percocet. Patient did followup with family doctor symptoms slowly getting better.				Y					Y	10/11/2007	10/11/2007	0	Unknown	OTH	PVT	Unknown	None	None			1						1	Injection site cellulitis; Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2453AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0985F~2~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294556	10/27/2007	AZ	45.0	45		M	10/26/2007	- Joint (elbows, knee, thigh, shoulders) pain - fever up to 101.5 - headache - chills - sweating - body aches									N	10/25/2007	10/26/2007	1		PVT	UNK		None	allergic to PCN, Sulfa			1						1	Arthralgia; Chills; Headache; Hyperhidrosis; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLAD67AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0294557	10/27/2007	WA	67.0	67		F	10/26/2007	Lymph node swelling 24 hour after injection affecting right maxillary node, right suprarcuilar node - seen on 10/26 - sxs resolving also c/o neck stiffness that has resolved									Y	10/23/2007	10/24/2007	1	None	PVT	UNK		Sinusitis				1						1	Lymphadenopathy; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U2441AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294558	10/27/2007	FL	0.3	0	.3	M	10/26/2007	Patient received inappropriate shots mistakenly 1. Varicella 0.5 ml 2. 0.5 ml - Fluvirin									Y	10/25/2007				PVT	PUB		None	None			1						1	Inappropriate schedule of drug administration; Wrong drug administered	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B049AA~1~IM~LL~DTAP (INFANRIX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81113~1~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HBHEPB~MERCK & CO. INC.~1244F~2~IM~RL~HIB + HEP B (COMVAX)~1|RV5~MERCK & CO. INC.~0877U~UNK~PO~MO~ROTAVIRUS (ROTATEQ)~1|VARCEL~MERCK & CO. INC.~L097U~1~IM~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0294559	10/27/2007	CA	57.0	57		F	10/24/2007	Flulaval admin 1630 hours (l) deltoid on 10/23/07 10/24/07 00:30 awoke with (l) arm - upper moderate pain muscle twitching left leg to toes, restless got out of bed to get Excedrin - walked 25 feet to get back in - blacked out. Awoke on floor estimate LOC 5- 10 minutes. Then frequent stool, chills, blurry vision x 10 minutes. Then back to bed - this AM feel fine.									Y	10/23/2007	10/24/2007	1	Left deltoid warmth erythema 3 x 4cm at injection site	OTH	OTH	MULTIVITAMIN; GLUCOSAMINE; FISH OIL	None	None			1						1	Abnormal faeces; Chills; Injection site erythema; Injection site warmth; Loss of consciousness; Muscle twitching; Pain; Restlessness; Vision blurred	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA075AA~5~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0294560	10/27/2007	MI	16.0	16		M	10/26/2007	Received vaccine 10/24/07. Red swollen area started 10/25/07. To see MD 10/26/07-area approx 3 x 3 on left arm, red, swollen, warm. To use Benadryl as needed. Keflex if not improved in next 2-3 days									U	10/24/2007	10/25/2007	1	None	PVT	PVT	None	None	Obesity			1						1	Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~U2505AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1026Y~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0294562	10/27/2007	WA	57.0	57		F	10/25/2007	Pain, swelling, erythema heat. Rx for anti-inflammation and antibiotics.				Y					Y	10/23/2007	10/24/2007	1		PUB	PVT	Premarin, Lisinopril, Azmacort, Hydrocodone	None	Yes-seasonal allergies			1						1	Erythema; Pain; Skin warm; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79241~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0294563	10/27/2007	DE	76.0	76		F	10/17/2007	Pain/burning when needle went in 15 min. post injection less pain/still stinging very, very little bleeding										10/18/2007	10/18/2007	0		UNK	UNK		on antibiotic				1						1	Eye irritation; Haemorrhage; Injection site pain	FLU3~SANOFI PASTEUR~U2498AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294564	10/27/2007	DE	71.0	71		F	10/25/2007	pt felt dizzy										10/25/2007	10/25/2007	0		OTH	UNK						1						1	Dizziness	FLU3~SANOFI PASTEUR~U2498AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294565	10/27/2007	FL	12.0	12		M	10/26/2007	Patient described rapid heart beat within 24 hrs. of vaccine. Pt. seen at urgent care. EKG normal Pt. referred to cardiology									Y	10/19/2007	10/19/2007	0	EKG-normal	PVT	UNK		None	None			1						1	Electrocardiogram normal; Heart rate increased	FLUN3~MEDIMMUNE VACCINES, INC.~500489~2~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0294566	10/27/2007	CA				F	10/19/2007	Swelling, pain, bruising to site redness									U	10/18/2007	10/18/2007	0		PUB	UNK	None	None	None			1						1	Injection site bruising; Injection site erythema; Injection site pain; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA311AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0294567	10/27/2007	MD	57.0	57		F	10/26/2007	Within 1-11/2 hours of receiving flu vaccine right upper lip became swollen and roof of mouth felt slightly like itching sensation-see progress notes-physician not sure if from vaccine or possibly R/t BP med (lisinopril)									Y	10/23/2007	10/23/2007	0		PVT	OTH	Avalide	None				1						1	Lip swelling; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA064AA~1~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0294568	10/27/2007	DE	73.0	73		F	10/24/2007	Had vaccine 10/23/07 @ 10:30 a.m Started feeling poorly during night. Believed had fever. Body ache-throbbing H/A. Ran fever up to 102 deg F Spoke to on 10/26-Feeling much better									Y	10/23/2007	10/23/2007	0		OTH	PUB	Elavil, Metoprolol, Klotonmzo	None	Accupril, taper Augmentin, Compazine, Darvocet, Dilaudid, Fostamax, Proxil, Moxide M.S.			1						1	Headache; Malaise; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79716~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0294569	10/27/2007	SC	5.0	5		M	10/26/2007	Swelling, heat + site, then over 24 hours, increased bilat ankle edema and heat, increased redness noted thigh. No urticaria, no signs of anaphylaxis.									Y	10/23/2007	10/24/2007	1		PVT	PUB		Finishing abx for sinusitis	None			1						1	Erythema; Injection site swelling; Injection site warmth; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U2435AA~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1346U~2~UN~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0294570	10/27/2007	TX	52.0	52		F	10/24/2007	Cellulitis, tenderness, swelling, increased warmth, erythema within 24 hours, Clindamycin given.									Y	10/23/2007	10/23/2007	0		MIL	MIL		Follow up Diabetes	N/A			1						1	Cellulitis; Erythema; Skin warm; Swelling; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA282EA~2~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0554U~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294571	10/27/2007	NY	1.5	1	.5	F	10/26/2007	C/O redness, warmth and swelling of (R) arm - 6cm x 4cm - posterior aspect of (R) arm. Dx - cellulitis vs. immunization rxn of (R) arm, Keflex 250mg/5ml tsp po BID x 10 days.									U	10/24/2007	10/26/2007	2	None	PVT	PVT	None	No - mild cold sxms	None			1						1	Cellulitis; Injection site erythema; Injection site swelling; Injection site warmth	DTAP~SANOFI PASTEUR~C2765AA~4~UN~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2474AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0273~3~UN~LA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0294572	10/27/2007	TX	1.0	1	.0	M	10/25/2007	Vaccine was administered on 10/23/07 and within 24 hrs patient experienced an urticaria type rash over entire body and became very irritable. No fever, and no other symptoms other than the above. Pt. was prescribed Benadryl for 5 days.										10/23/2007	10/23/2007	0	None	PVT	UNK			Cleft Palate, Allergic Rhinitis, C			1						1	Irritability; Rash generalised; Urticaria	FLU3~SANOFI PASTEUR~UT2460DA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294573	10/27/2007	MN	33.0	33		F	10/26/2007	Pt reports sore arm, welt, redness after injection. Day after woke up with face and neck red - feels hot, throat and eyes itching. To use Benadryl for symptoms per doctor.										10/25/2007	10/25/2007	0		PUB	OTH		None	Allergic rhinitis			1						1	Erythema; Eye pruritus; Pain in extremity; Skin warm; Throat irritation; Urticaria	FLU3~SANOFI PASTEUR~U2445AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294574	10/27/2007	NC	4.0	4		F	10/26/2007	Swelling, sl tenderness (L) leg				Y					U	10/23/2007	10/23/2007	0		PVT	PUB		None	Heart transplant @ 3rd 2 deg cardiomyopathy			1						1	Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2435AA~5~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294575	10/27/2007	OR	81.0	81		F	10/19/2007	Received flu vaccine Monday about 1 PM. Hives came Tuesday eve. about 6:30 - itchy around neck and then whole body covered. Called PMB. He ordered Allegra 1 qd 180 mg and famotidine with no results.				Y					Y	10/15/2007	10/16/2007	1	None	PUB	PUB	Lipitor	None	High cholesterol		OR200743	1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2504AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294594	10/27/2007	VA	66.0	66		F	10/27/2007	Dizziness began the day following the flu vacination and irregular and fast heart beats.  Just did not feel good.  Was dizzy sitting chair but tolerable.  Was much worse standing up and walking making me unsteady and bumping into walls and furniture.  Gathered all my medications into a paper bag in case I passed out or something and my husband might have to take me to the emergency room.  In evening before bed finally took a Dramamine to see if that would help the dizziness and help me sleep.  The next day I was still dizzy.  This is two days after the flu shot and I am still dizzy, but my heart has calmed down.									N	10/25/2007	10/26/2007	1	This is for Item 13.  I don't know the manufacturer of the flu vaccine given at Medical Center where I took the vaccine and it is Saturday today and the doctor's office is closed so I can't get the information needed to answer #13, which is why I put unknown.	UNK	UNK	Synthroid, Vytorin, Allegra, Norvasc, Plavix, Protonix, Wellbutin XL, which are my usual daily medications taken that morning	None	Allergic to dust mites and mold, hypothyroid, hypertension, high cholesterol, TIA's, left bundle branch block, irregular heart beat and heart murmur, mild depression, fibromyalgia, IBS, acid reflux	None~ ()~~0.00~In Patient		1						1	Dizziness; Gait disturbance; Heart rate increased; Heart rate irregular; Malaise	FLUX~UNKNOWN MANUFACTURER~?~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0294595	10/27/2007	FL	65.0	65		F	10/27/2007	The day after receiving the Flu vaccine, patient had numbness in right hand. Numbness progressed to both hands, arms and legs with weakness. On 10/8/2007, patient was admitted through the ER with Guillain Barre Syndrome.  GBS confirmed by Spinal Tap.  Patient treated with gamma globulin for 5 day, but continues to experience worsening numbness and weakness.  11/27/07 Reviewed hospital medical records which reveal patient experienced tingling & numbness of both hands & bilateral LEs, ataxia, weakness & difficulty ambulation which progressed since 10/1.  Admitted 10/8-10/30/2007.  Neuro & vascular surgery consults done.  Areflexic Tx w/IVIG x 5 days w/improvement in pain but remained weak & deconditioned.  D/C to rehab s/p discharge. FINAL DX: Guillain Barre syndrome. Per 60 day follow up: Aortic Aneurysm surgery 12/26/2007. Left leg vascular surgery 12/28/2007. Vision loss 01/05/2008. Pt. hospitalized for 5 wks fwith GBS & discharged to home. Aortic aneurysm aggravated by pt. use of arms to lift & move self. Pt re-admitted to hospital with severe back pain later determined to be aortic aneurysm. 1/19/2010 Still has drop foot.				Y	Y	21	Y		N	10/01/2007	10/02/2007	1	LABS: LP revealed CSF protein 77 (H), glucose 66 (N), IgG 3100 mg/dL (H).  EMG/NCS x 2 revealed demyelinating neuropathy.  Plasma IgG 772 (L). Blood c/s (+) MRSA.  EKG w/T-wave inversion.  MRI brain revealed small vessel ischemic changes.  CT abdomen/pelvis revealed possible leaking AAA but vascular surgery evaluated as neg.	MIL	OTH			PMH: HTN, dyslipidemia, hyponatremia, hyperkalemia, PVD, chronic pain, DDD of spine, sleep apnea, constipation, chest pain, COPD, s/p AAA repair 11/2000, depression, stable angina, s/p MI w/2 stents, CHF, atrial fibrillation.  TIA & Carotid endarderectomy 8/07. Ex-smoker			1						1	Aortic aneurysm; Asthenia; Back pain; Blindness; Blood product transfusion; Condition aggravated; Guillain-Barre syndrome; Hypoaesthesia; Lumbar puncture; Lumbar puncture; Muscular weakness; Pain; Vascular operation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0294596	10/27/2007	MD	46.0	46		F	10/27/2007	significant swelling on right side of neck - from gland up to ear.  Have not yet seeked trt.										10/25/2007	10/26/2007	1		UNK	UNK		none	none			1						1	Local swelling	FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0294597	10/27/2007	NY	58.0	58		F	10/27/2007	Pain began at injection site (left arm) on Oct 22, 2004 (4 days after injection on Oct 18).  Pain worsened and spread to upper arm and left side of neck in next several days.  Patient saw physician on Oct. 25 who misdiagnosed the problem as a pinched nerve.  Pain became intolerable the evening of Oct 25, and patient went to emergency room where she was given valium and percoset.  On Oct 26, patient noticed a rash at the injection site and visited her physician who diagnosed shingles.				Y					U	10/18/2007	10/22/2007	4		UNK	PVT	phenobarbitol (90mg daily)	none	osteoarthritis			1						1	Herpes zoster; Injection site pain; Injection site rash; Neck pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2441AA~7+~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294599	10/27/2007	WA	3.0	3		F	10/27/2007	She received the vaccine around 10:00am and had a fever of 100.1 around 8:00PM.  She woke up early the next morning around 4am and had a fever of 102.5.  The fever lasted for two days and with Tylenol and Motrin the fever stayed between 101 and 103 degrees.  It was pretty constant at 102 degrees.  She complained of neck pain and her stomach hurt.									Y	10/24/2007	10/24/2007	0		UNK	UNK		None	None			1						1	Abdominal pain upper; Neck pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0294606	10/27/2007	MD	34.0	34		F	10/26/2007	None stated									Y	10/23/2007	10/23/2007	0	none known	PUB	OTH	Singulair, Zyrtec, Flonase, Plaquenil, Albuterol	Discoid lupus	Allergy Diflucan, tapazole			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2478BA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294607	10/27/2007	OR	2.0	2	.3	F	10/18/2007	10-16-07 patient received Pediarix to right thigh along with flu shot. Same evening started with some redness and swelling, worse today. Presented to clinic with large red area 9 x 9cm with one area 9 x 12cm, warm not hot to touch. Evaluated by doctor and treated with Benadryl and Ibuprofen. Patient walking fine, no noted tenderness f/u 10-19-07 area still firm, but redness gone, only very light pink, non tender									Y	10/16/2007	10/16/2007	0		PUB	PUB	None	None	None		OR2007H	1						1	Injection site erythema; Injection site swelling; Injection site warmth	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B127AA~5~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2504AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB163AB~2~IM~LL~HEP A (HAVRIX)~1	USA		Influenza
0294609	10/27/2007	CO	61.0	61		F	10/22/2007	Fever, chills/ myalgia, redness right deltoid/ bicep, pain in right arm with movement. Pain radiates to axilla right. Treated with oral steroids									Y	10/17/2007	10/17/2007	0		PVT	UNK	PREMARIN	None				1						1	Axillary pain; Chills; Myalgia; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U2441AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0889F~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294610	10/27/2007	CO	48.0	48		F	10/23/2007	Received Influenza and Pneumonia vaccine 10-18-07. Stated she had chills, 102 F fever, headache and could not raise arm the night of 10-18-07. 10-19-07 she had low grade fever, pain at site, dizzy. Headache and arm blotchy red and swollen. 10-22-07 States she feels better. Arm slightly swollen.									Y	10/18/2007	10/18/2007	0		OTH	PVT	Unknown	Unknown	Unknown			1						1	Chills; Dizziness; Erythema; Headache; Hypokinesia; Injection site pain; Pyrexia; Rash macular; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80959~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1005F~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294612	10/27/2007	MI	1.0	1	.0	F	10/26/2007	Localized redness and swelling at injection site that occurred almost immediately. Treated with ice and Benadryl observed for 30 minutes without respiratory compromise or increase in rash size 10-26-07 rechecked patient and doing fine.									Y	10/25/2007	10/25/2007	0		PVT	PVT	None	None	None			1						1	Immediate post-injection reaction; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2500AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1275F~3~IM~RL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0527U~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~808702E~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1251U~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0294613	10/27/2007	MA	41.0	41		F	10/25/2007	Itchiness at site immediately 10/23/07 3am- itchiness entire body; tingling of face 10/24/07 and chin 1pm 10/24/07 - took Benadryl 25mg - 3pm called BOH advised to seek medical treatment; called PCP. Treated by phone; prescribed Hydrazaline QID									Y	10/23/2007	10/23/2007	0	None	OTH	PUB	None	None	allergy to Bactrim; Codeine; Percocet			1						1	Injection site pruritus; Paraesthesia; Pruritus generalised	FLU3~SANOFI PASTEUR~AFLUA050AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294614	10/27/2007	IN	1.0	1	.0	M	10/26/2007	Mom states patient had diarrhea and rash on back.									Y	10/08/2007	10/09/2007	1		PVT	UNK						1						1	Diarrhoea; Rash	FLU3~SANOFI PASTEUR~UT2459KA~UNK~SC~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~9104516~UNK~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1107U~UNK~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0294600	10/28/2007		24.0	24		F	10/28/2007	Headaches, Blurry Vision, Dizziness, Excessive Tiredness, Cloudy Head, Stiff and Painfull left shoulder and left elbow joint (All started on 12 Oct and are still present at present).  I went to see 3 different flight doctors, all 3 saying different things.  I was put on DNIF (Duties not including flying, essentially, put on bed rest) for 48 hours.  Symptoms became a little less apparent, but still very present, but was still returned to work.				Y					N	10/12/2007	10/12/2007	0	Blood test done--1st doctor suspected electrolyte imbalance or possible reaction to shots.	MIL	MIL	NONE	NONE-IN GOOD HEALTH PREVIOUSLY	NONE			1						1	Activities of daily living impaired; Arthralgia; Blood test abnormal; Cognitive disorder; Dizziness; Electrolyte imbalance; Fatigue; Headache; Joint stiffness; Musculoskeletal pain; Vision blurred	ANTH~EMERGENT BIOSOLUTIONS~FAV105~1~IM~LA~ANTHRAX (BIOTHRAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA040AA~3~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|TYP~SANOFI PASTEUR~A0221~UNK~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0294602	10/28/2007	PA	37.0	37		M	10/28/2007	I felt like I was going into shock. Severe chills, feaver, bad body and head aching, nausea, weakness, coughing.The chills went away after the first night, but I'm still feeling aweful and will be calling out of work on Monday (the shot was administered on Sat.)									N	10/28/2007	10/28/2007	0		UNK	PVT	none	none	none			1						1	Asthenia; Chills; Cough; Headache; Malaise; Nausea; Pain; Pyrexia; Shock	FLU3~SANOFI PASTEUR~U2508AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294603	10/28/2007	CA	32.0	32		M	10/25/2007	Patient felt like fainting. We called 911. The EMT crew members took the patient's vital signs. The patient stated he was okay so the EMT crew left without taking him the the hospital									Y	10/25/2007	10/25/2007	0	Blood pressure, blood sugar and EKG were monitored by EMT team. All were okay.	UNK	PVT						1						1	Blood glucose normal; Blood pressure normal; Dizziness; Electrocardiogram normal	FLU3~SANOFI PASTEUR~42463AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294604	10/28/2007	IL	80.0	80		F	10/28/2007	Patient had a flue shot at 9:00 A.M.sunday 10/28/07.   At 4:00 P.M.had strong shiver/chills fell like vomiting; she asked for cold water;at 6:00 P.M. had 100.4 fever. Given her one ALEVE pill; at7:30P.M.fever down to100.0. at 9:00P.M.fever down to 99.4   She never had a influenza vaccine before.									N	10/28/2007	10/28/2007	0		UNK	PVT	NONE	NONE	NONE	NONE~ ()~NULL~~In Patient		1						1	Chills; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0294605	10/28/2007	MI	6.0	6		F	10/28/2007	Patient received Fluzone influenza vaccine on 10/24/07 at 4pm in left arm. On 10/25/07 injection site was warm to touch. On 10/26/07 at 8:45pm child woke up crying due to pain in left arm. Upon evaluation, arm had 4 x 4 patch of red skin at and below injection site. Arm was also considerably swollen and hot to touch. Arm circumference was measured and affected arm (left)was 1 larger (8.5) than right arm (note: childs predominant arm is the right arm). Child's on call physician contacted and they suggested a visit to after hours clinic for a diagnosis. Child taken to Hospital After Hours Pediatric Clinic and seen by Dr. Diagnosis at time of visit was cellulitis with prescription for Omnicef 200mg BID x 10 days initiated. Within 24 hours of antibiotic initiation the affected site had cooled and within 48 hours the redness and swelling had subsided. Antibiotic treatment to continue for 8 more days at the time this adverse event report was submitted.				Y					U	10/24/2007	10/26/2007	2		UNK	UNK	none	none	Biaxin	none~ ()~~0.00~In Patient		1						1	Cellulitis; Crying; Injection site erythema; Injection site warmth; Oedema peripheral; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~u2510AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294233	10/29/2007		38.0	38		F	10/30/2007	We received from a consumer on 19 OCT 2007: A 38-year-old woman, was vaccinated with Fluvirin, batch-no. 78990, i.m. on 02 OCT 2007 at 06:00 p.m. Four hours after the vaccination she began having ringing in the ears, clogging of the ears, vomiting and vertigo. Saw MD next day. Had another episode of above on 04 OCT 2007. Saw MD on 05 OCT 2007 who gave her some Antivert for the dizziness. She began to experience extreme pressure in her head so her husband took her to the emergency room and she was admitted to the hospital for 10 days (05 to 15 OCT 2007). Diagnostic: aseptic meningitis. The patient still continues to have some pressure in her head but it is being managed by pain medication. Company assessment: Seriousness criterion: hospitalisation. Causality: unrelated. Causality excluded due to short onset interval and nature of disease. Expectedness assessment according to label: The reported symptoms are not expected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measures necessary.					Y	10			N	10/02/2007	10/05/2007	3		OTH	OTH	No other medications	Unknown			MA20071146	1						3	Headache; Meningitis viral; Migraine; Nausea; Tenderness; Vertigo; Blindness transient; Deafness unilateral; Dizziness; Headache; Malaise; Meningitis viral; Vomiting; Dizziness; Ear discomfort; Headache; Intracranial pressure increased; Meningitis aseptic; Tinnitus; Vertigo; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78990~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78990~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~2|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78990~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~3	USA	Hospitalisation	Influenza
0294294	10/29/2007	CA	71.0	71		F	10/23/2007	I awoke 12 hrs later with an arm so painful that I didn't sleep the rest of the night. Any motion, not even involving my arm, was painful. In spite of aspirin, my temp was 102 on Wed. and 100 on Thursday. I phoned my doctor at 9 am Wed morning.				Y					Y	10/16/2007	10/17/2007	1		OTH	UNK		No	No			1						2	Influenza like illness; Insomnia; Neck pain; Pain in extremity; Body temperature increased; Pain in extremity; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~LA~PNEUMO (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0294648	10/29/2007	TX	59.0	59		F	10/29/2007	No immediate reaction.  Vaccine given on 10-16-07.  Arm sore on 10-18-07.  To doctor on 10-19-07, hospitalized with possible cellulitis.  Condition deteriorated over this past week, requiring intensive care and ventillator support.  Continues in intensive care on ventillator and have not been able to talk with patient to learn what symptoms were experienced or how they came on.  11/12/07 Link w/294648. 11/06/2007 MR received for DOS 10/21/2007- 11/23/2007.   Pt developed pain at flu injection site.   Subsequently developed fever, chills, and rigors. Seen by PCP and txd with pain med however developed redness and swelling at site and weakness so presented to ER. VS 84/54, 132, 22 and T=101.7'F. PE (+) for LUE very hot with swollen joints. (+) tenderness.  Pt rapidly developed multi system organ failure 2' to sepsis and probable necrotizing fasciitis. Multiple consults:  Surgical: for necrotizing fascitis with multiple organ system failure. Taken to OR x2 for Massive Incision, Drainage and Debridement of L Upper Arm and shoulder portion of the back, R Femoral artery Art Line placement and I & D of flank with extremely large incision. Renal: for Renal Failure/insufficiency.   Cardiac: for tachycardia with PACs. Pt was hemodynamically unstable during first surgery surgery and remained intubated thereafter. Twitching noted by one consultant-small seizures. 11/28/2007 D/C Summary received.  D/C DX: Septic shock.  Respiratory Failure.  Acute Renal Failure resolved.  Necrotizing Fasciitis s/p intubation and extubation. Fever.  Leukocytosis.  Tachycardia.  Hypotension.  Elevated LFTs.  Acalculous Cholecystitis s/p cholecystectomy.  Open Wound.  Metabolic Acidosis.  Rhabdomyolysis.  Systemic Inflammatory Response Syndrome.  Mitral Regurgitation.  Mild Concentric L Ventricular Hypertrophy My mother is still recovering from Necrotizing Fasciitius. She has had 5 toes amputated on her right foot and may need more surgery. She has had a total of 5 surgeries.			Y	Y	Y	32			N	10/16/2007			Unknown. Labs and Diagnostics:  WBCs 18.4  with 19 bands. BUN 31.  Creatinine 2.4.  Bicarb 16.  CPK 1153. CKMB 19.6, later 156 amd 0.5. SGOT 1114.  SGPT 1243.q Troponin 4.46.  FSP >40. Wound Gram stain (-), cultures (-). Blood cultures (-).  MRSA screen (-). UC (-). Echocardiogram with EF 70%, mild aortic insufficiency, L ventricular hypertrophy. 2+ mitral regurg.  2+ tricuspid regurg. Mild pulmonary insufficiency. small pericardial effusion. CXR (+) for pleural effusion.	OTH	OTH	Patient taking:  Zyrtec, Nasacort, and Mobic.	Patient denied.	Septra, as stated by patient. PMH:  Bladder suspension. Allergy to Septra.	Denies~ ()~~0.00~Patient|Unknown~ ()~~0.00~Sibling|Unknown~ ()~~0.00~Sibling		1						1	Asthenia; Cellulitis; Intensive care; Mechanical ventilation; Cellulitis; Influenza like illness; Injected limb mobility decreased; Injection site erythema; Injection site pain; Injection site warmth; Multi-organ failure; Surgery; Cellulitis; Intensive care; Mechanical ventilation; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78994~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78994~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~3	USA	Life Threatening,Hospitalisation	Influenza
0294649	10/29/2007	TN	57.0	57		M	10/29/2007	Immunization was on Friday October 26 at about 3:30pm. Around 8pm becane a mild cough with irritation in throat and trachea. By 8:30pm neck felt swollen and some numbness below corners of mouth. Continued coughing, eyes red and yellow substance oozing from corners of eyes. General achey feeling in legs. At about 9PM took 50 mg of diphenhydramine. About 40 minutes late began breathing easier, swelling seemed to get better. Coughing stopped. Numbness in corners of mouth eased. Slept through the night. Saturday morning about 8am, still had throath thickness sensation, took 25mg of diphenhydramine. 10am Saturday morning all symptems were gone. Symptems did not return.									Y	10/26/2007	10/26/2007	0	None - did not go to a medical facility or doctor.	PVT	PVT	Xalatan Ophthalmic Drops - one drop left eye at bedtime.	None	No known allergies, Heart Block - no medications - Pacemaker 2005.			1						1	Cough; Eye discharge; Hypoaesthesia; Local swelling; Ocular hyperaemia; Pain; Throat irritation	FLU3~SANOFI PASTEUR~U2526AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294650	10/29/2007	CA	60.0	60		F	10/29/2007	Chill and fever (102).  Extreme pain in arm of injection, unable to lift arm for 2 days.  Extreme nausea and lightheadedness for two days.  Migraraine headache, which is still continuing.  Passed out for the first day.  Onset of symptoms about 5 hours after injection.									U	10/25/2007	10/25/2007	0		PVT	PVT		None, healthy	Herpes, heart murmer, mitral valve prolapse	none~ ()~NULL~~In Patient		1						1	Chills; Dizziness; Injected limb mobility decreased; Loss of consciousness; Migraine; Nausea; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~4244IAA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0802U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294651	10/29/2007	OH	1.25	1	.2	M	10/29/2007	High Fever, fussiness.  Tmax =104.9									Y	10/26/2007	10/26/2007	0		PVT	PVT		no	none of significance -- has eczema			1						1	Irritability; Pyrexia	DTAP~SANOFI PASTEUR~c2797AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~ut2459pa~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~uf144AA~4~IM~LL~HIB (ACTHIB)~1	USA		Influenza
0294652	10/29/2007	UT	44.0	44		F	10/29/2007	On the day that I receieved my flu shot I developed aches and pain by that afternoon. The following day I hurt even worse and I started coughing. That day I aslo, lost my voice and have since not gotten it back to normal. I still have a cough and aches. Today would be the seventh day since I received the shot.									N	10/23/2007	10/23/2007	0		UNK	UNK		No known illness at the time of the vaccination.	none			1						1	Aphonia; Cough; Pain	FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0294653	10/29/2007	TX	48.0	48		F	10/29/2007	unilateral lymphadenopathy on side of injection, nerve pain, weakness in foot and leg side of injection, chills, muscle aches, nausea									N	10/23/2007	10/25/2007	2		PVT	UNK	mycardis hct	none	hypertension			1						1	Chills; Hemiparesis; Lymphadenopathy; Myalgia; Nausea; Neuralgia	FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0294654	10/29/2007	CA	37.0	37		F	10/29/2007	Within 24 hours of flu vaccine,began with hives.  Started antihistamine immediately and prednisone the following day.  That night, face began to swell, lips, mouth, tongue and then throat. Visited ER and was given IV with prednisone and antihistamine and Zantax.  Admitted to hospital for  the next 24 hours. Went home and continued on Prednisone for one week. Still taking the antihistamine.  11/7/07 Received vax record from provider.  VAERS database updated w/same./ss 12/7/07 Reviewed hospital medical records which reveal patient experienced new onset hives. Saw pcp & tx w/steroids & antihistamine.  Worsened & admitted 10/13-10/14/2007.  On admit had hives, facial swelling & throat constriction.  Tx w/IV steroids & antihistamine.  Had 1 further episode of hives that responded to steroids.  D/C to home on tapering steroids & antihistamine.  Also prescribed epi-pen. FINAL DX: Hives.				Y	Y	1			Y	10/08/2007	10/11/2007	3	Might have been an allergic reaction to the flu vaccine. I do not have any known allergies (eggs). LABS: WBC 9.1 (N)utros 86.9% (H), lymphs 9.2% (L).  Electrolytes & UA WNL.	UNK	UNK	NO	NONE	NONE PMH: family hx of allergies & asthma.			1						1	Hypersensitivity; Lip swelling; Pharyngeal oedema; Swelling face; Swollen tongue; Urticaria	FLU3~SANOFI PASTEUR~78478~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0294655	10/29/2007	CO	65.0	65		F	10/29/2007	Patient received the shot from intern and the injection site was slightly swelled up.  We asked her to check back with us 15 minutes later and the swelling was decreased. Patient said there was no pain.									U	10/24/2007	10/24/2007	0		UNK	UNK		none	not known			1						1	Injection site swelling	FLU3~SANOFI PASTEUR~u2488aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0061u~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294656	10/29/2007	WA	33.0	33		M	10/29/2007	swelling/rash at immunizations site, above site on shoulder radiating around entire arm.  swelling in neck and armpit									Y	10/17/2007	10/25/2007	8		MIL	MIL						1						1	Injection site rash; Injection site swelling; Oedema peripheral; Swelling	ANTH~EMERGENT BIOSOLUTIONS~FAV111~1~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~500429P~7+~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB438BA~1~IM~UN~HEP B (ENGERIX-B)~1|SMALL~PFIZER\WYETH~4020076~1~UN~LA~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~A0394~2~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0294658	10/29/2007	PA	1.0	1	.0	M	10/29/2007	Extensive maculopapular rash on trunk/extremities/head and diaper area.  Rash started 10/28/07.				Y					U	10/18/2007	10/28/2007	10		PVT	PUB	none	none	none			1						1	Rash maculo-papular	FLU3~SANOFI PASTEUR~ut2456ba~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~0478u~1~SC~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0294662	10/29/2007	WA	71.0	71		F	10/29/2007	States that she developed a maculopapular rash on both arms and legs.  Rash was nonpuretic. No swelling at site. It is still slightly visible.  States she had no changes in diet, laudry soap, or medications prior to vaccination.									Y	10/15/2007	10/17/2007	2		PUB	PVT	Gabipent and Celebrix	No	NKDA Has lymphedema from breast cancer			1						1	Rash maculo-papular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU315BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0294664	10/29/2007	GA	48.0	48		F	10/29/2007	Client had Pneumonia and Flu vaccine on 10-25-07.  Site of Pneumonia vaccine (R) arm became painful and swollen that evening.  Over the weekend Oct 27 &28 states it hurt to move her arm and red streaks were coming from the area where shot was given.  Today has temp of 97.9 and edema to deltoid area and upper arm. Some limitation of movement due to pain and edema. Advised to see MD for evaluation.  Use cool compresses and APAP as needed.									Y	10/25/2007	10/25/2007	0		PUB	PUB	Lotensin HCT, Toprol XL, Benadryl,	None	ASA			1						1	Body temperature; Cold compress therapy; Injected limb mobility decreased; Injection site erythema; Injection site pain; Injection site streaking; Injection site swelling; Oedema	FLU3~SANOFI PASTEUR~U2507AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0601F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294665	10/29/2007	VA	3.0	3		M	10/29/2007	Arm red, hot to touch, swollen - started afternoon of imm.  Progressed to emcompass shoulder to elbow by Wednesday afternoon.  Fluid filled blisters by evening of 10/17/07; on antibiotic (Keflex)				Y					U	10/16/2007	10/16/2007	0	culture done & pending	UNK	UNK		none	history of eczema		VA07019	1						1	Blister; Culture; Erythema; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U2478CA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294666	10/29/2007	IN	54.0	54		F	10/29/2007	Patient presented here for over-all rash following a flu shot given where she is employed.				Y					Y	10/29/2007	10/29/2007	0	MD examined patient and found a diffuse rash pruitic in nature and spreading. Treated with DepoMedrol 80mg IM in office and observed for 30 minutes. Rash resolving following injection and observation.	UNK	UNK	Niacin 500mg, Flonase, Atanolol, Allegra	NONE	NONE			1						1	Rash generalised	FLU3~SANOFI PASTEUR~U2494AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294670	10/29/2007	SC	53.0	53		F	10/29/2007	FEELING FAINT,NAUSEA,DIZZY,SWEATING, AND A LARGE LUMP IN MY RIGHT LYMPH NODE									N	12/29/2006	12/30/2006	1	BLOOD WORK, X-RAYS , MRI AND MORE X-RAYS	PVT	PVT		NONE	NONE			1						1	Dizziness; Hyperhidrosis; Lymphadenopathy; Nausea; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0294671	10/29/2007	TX	46.0	46		M	10/29/2007	Patient went to his HR department and showed his arm area were shot was given. He described it as red, swollen, warm to touch. I myself did not see it.									U	10/23/2007	10/23/2007	0	None	UNK	UNK	UNKnown			~Influenza (Seasonal) (Fluzone)~~0.00~In Patient		1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~u2494AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294672	10/29/2007	VA	27.0	27		F	10/29/2007	Patient c/0 fever of 101.8 approximately 12 hours after injection and body aches.  Had cough, no sob.  Symptoms resolved on their own.									Y	10/24/2007	10/24/2007	0		UNK	PVT						1						1	Cough; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2529AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2769AA~1~IM~UN~TDAP (ADACEL)~1	USA		Influenza
0294673	10/29/2007	IL	44.0	44		F	10/29/2007	Shot was given on Tuesday October 24,2007. On Wednesday I started have high fevers, chills. Hoarseness and soreness in throat. Called my doctor on Monday10- 29-06 who prescribed me some antibotics still experiencing some  fever hoarness, chills and sore throat.									N	10/21/2007	10/22/2007	1		PUB	UNK		allergies only	Sinitus Rhinitis			1						1	Chills; Dysphonia; Pharyngolaryngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0294674	10/29/2007	NY	73.0	73		M	10/29/2007	Pt notified office today that after the Zostavax vaccine on 10/26/07 he experienced fast heart rate and weakness about 3 hrs.later lasting  several hours. States he went to be and was better in the morning.									Y	10/26/2007	10/26/2007	0		PVT	UNK			penicillin			1						1	Asthenia; Heart rate increased	FLU3~SANOFI PASTEUR~U2529AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~1087U~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0294676	10/29/2007	IL	72.0	72		F	10/29/2007	PATIENT RECIEVED FLUZONE VACCINE ON 10/24/07. 2 DAYS LATER, PATIENT STATES SHE NOTICED A RASH FORMING ON SHOULDER/NECK AREA. PATIENT NOTIFIED US ON 10/29/07 TO INFORM US OF RASH AND SAID SHE WAS NOT SURE IF IT WAS DUE TO VACCINE OR IF IT WAS A SHINGLES FLARE-UP. PATIENT STATES RASH IS CURRENTLY FADING									U	10/24/2007	10/29/2007	5		UNK	UNK	NEURONTIN	POSSIBLE SHINGLES - PT HAS BEEN ON MEDICATION FOR ABOUT A YEAR, BUT WAS FEELING FINE ON DAY OF VACCINATION	SHINGLES			1						1	Rash	FLU3~SANOFI PASTEUR~U2499AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294678	10/29/2007	NM	48.0	48		F	10/29/2007	REPORTS SHE BROKE OUT IN HIVES ALL OVER HER BODY. WOKE UP THE FOLLOWING DAY W/WELTS/HIVES.  DENIES SOB OR DIFFICULTY BREATHING.    INDICATES SHE WENT TO CLINIC. SAW DR.  WHERE SHE CLAIMS RECIEVED RX. (STERIOD MEDICATION (2 TABS X3DS THEN 1 TAB X 2DS.)									Y	10/16/2007	10/17/2007	1	N/A	UNK	UNK		DENIES		HIVES-UBE~Influenza (Seasonal) (Fluvirin)~5~7.80~In Patient		1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78994~6~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0294680	10/29/2007	WI	66.0	66		F	10/29/2007	She developed swelling in her right arm from the elbow to shoulder, hours after the immunization. She than had redness, warmth and pain in that area and was seen in Urgent Care 2 days after getting the shot.  She was put on Cephalexin 500mg, 4 times daily for 10 days. She was seen in follow up 4 days later and only had mild residual tenderness and swelling.				Y					Y	10/19/2007	10/19/2007	0		PVT	PVT	Verelan, Nasonex, Alprazolam, Doxepin, Lisinopril, Celexa, Allegra-D, Fosamax, Protonix, Mucinex, Ultram, Glucosamin Chondrotin Comples, Estroven	None.	Benign Hypertension, Reflux Esophagitis, Cardiac Dysrhythmia, Common Migraine, Depressive Disorder, Allergic Rhinitis, Osteopenia, Peptic Ulcer			1						1	Injection site erythema; Injection site pain; Injection site warmth; Oedema peripheral; Tenderness	FLU3~SANOFI PASTEUR~U2505AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0932L~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294681	10/29/2007	NJ	69.0	69		F	10/29/2007	Left arm became inflammed red and hot to touch.  Arm was extremely painfull when lifted or during slight movement. These symptoms became worse as time went on.  Patient called the CDC info line and was instructed to seek medical attention.  Patient went to her physician and was diagnosed with Cellulitis.  She was perscribed Doxycycline Hyclate 100 mgs.				Y					U	10/27/2007	10/27/2007	0	Diagnostic/laboratory tests have not been performed at the time of this entry.	UNK	UNK	Pravastatin SOD 40 MG TAG TEVA, Toprol XL 500MG, 1-80mg aspirin	None	Allergy-Pennicillan, High Blood Pressure, High Cholesterol			1						1	Cellulitis; Erythema; Inflammation; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~02507aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0038U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294683	10/29/2007	CA	26.0	26		M	10/26/2007	Patient received a flu vaccine and a pnuemovax injection to the right deltoid IM. Right deltoid is mottled, red, swollen and extremely painful w/movement and to touch.				Y					U	10/24/2007	10/24/2007	0		PVT	PVT			ASA allergy;  Patient is HIV +.			1						1	Erythema; Livedo reticularis; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2498AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~002DU~UNK~IM~LA~HEP A (VAQTA)~1|PPV~MERCK & CO. INC.~11324~4~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294687	10/29/2007	CA	53.0	53		M	10/29/2007	EXCEMA ON HANDS, TOES, SHINS.  RED RASH FROM WAIST TO MID THIGH.				Y					Y	10/16/2007	10/18/2007	2		UNK	UNK	LESCOL(20MG),RANITIDINE(150MG),TRIAM/HCTZ  37.5-25	NONE	HIGH CHLOESTEROL, HIGH BLOOD PRESSURE			1						1	Eczema; Rash	FLU3~SANOFI PASTEUR~49281-0380-15~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294688	10/29/2007	OH	4.0	5		F	10/29/2007	REDNESS, SWELLING, AND SLIGHT PAIN AROUND INJECTION SITE LEFT LEG ONLY, ONSET 36 HOURS AFTER INJECTION. PATIENT WAS SEEN AGAIN IN THE OFFICE, FELT TO HAVE A LOCAL REACTION, ADVISED TO TREAT WITH WARM TOWELS AND IBUPROFEN AND TO CALL IF REDNESS PROGRESSED OR IF THE LEG BECAME EXTREMELY TENDER. SHE WAS ABLE TO WALK AND WAS PLAYFUL.									U	10/24/2007	10/25/2007	1	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site pain; Injection site swelling; Local reaction	DTAP~SANOFI PASTEUR~U1813BA~5~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2523AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0273~4~IM~LL~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0294696	10/29/2007		55.0	55		M	10/29/2007	We received from a consumer on 15 OCT 2007: A 55-year-old man, was vaccinated with Fluvirin, batch-no. 81454 G and 78990 reported, i.m. on 09 OCT 2007. The patient stated that within 1 minute after the vaccination he began to feel totally out of it, my heart began to beat very fast, I became instantly fatigued. On 15 OCT 2007 the patient was questioned as to whether he had any continuing symptoms, he promptly responded, 'I have every symptom. Multiple attempts were made to determine exact symptoms but outside a single mention of pneumonia, the patient always responded with I have every symptom. Additionally, he stated that, if I were to tell you one or two then you will miss them all. He would not expound upon his pneumonia symptoms. Company assessment: Seriousness criterion: medically significant. Causality: unrelated. Pneumonia is in most cases of bacterial or viral origin and inactivated influenza vaccines are not known to be able to cause pneumonia. Diagnosis has not been assured.									N	10/09/2007	10/09/2007	0		OTH	OTH	No other medications	Unknown			MA20071122	1						1	Fatigue; Feeling abnormal; Palpitations	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78990~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0294698	10/29/2007	NY	30.0	30		F	10/29/2007	Severe headache and fever, lightheaded sx's day after getting vaccinated.  12/06/2007 MR received for DOS 10/27-31/2007 and 11/2-5/2007 with D/C DX (10/31/07):  Viral illness, possible viral meningitis.  UTI due to E. coli.  R maxillary sinusitis.  Retention cyst or polyp of the L maxillary sinus.  Bilateral ethmoid sinus disease.  Elevated fasting glucose.  D/C Dx (115/07):  severe spinal headache improved s/p blood patch.  Muscle tension H/A.  Negative MRI spine.  R maxillary sinusitis with opacification.  Pt presented to ER with severe H/A unrelieved by pain meds.  Pt had experienced aches and chills since the day prior to admission. Pt developed a fever and severe dizziness. Was admitted for possible meningitis. Tx with pain meds, abx, Meclizine with some improvement. Pt was readmitted 11/27/07 for severe positional H/A with nausea and vomiting. A blood patch was performed with gradual improvement.					Y	7			Y	10/25/2007	10/27/2007	2	Labs and Diagnostics: CT Brain WNL. MRI brain with opacification of R maxillary sinus, retentioncyst/polyp of the L maxillary sinus, bilateral ethmoid sinus disease.  CXR normal.  CBC WNL.  Lumbar puncture: CSF with 50 WBCs and protein of 69.0.  CSF viral cx (+). CSF gram stain (-).  CSF culture (-). UC (+) for E. coli.  Blood culture (-).	PVT	PVT	PREMARIN; SINGULAIR; ADVAIR; ULTRAM; PROTONIX; ALBUTEROL; ALBUTEROL; ARUSOL	None	LEVAQUIN; KEFLEX; AMOXICILLIN; aspirin; Biaxin. PMH:  ovarian cysts, hayfever, asthma, bronchitis, URI, musculoskeletal pain, sacroiliac, tobacco disorder, lactose intolerance, hyperlipidemia, otitis externa, benign paroxysmal positional vertigo, abdominal pain, dysfunctional uterine bleeding, reflux, status asthmaticus, 33 weeks gravid, gestational diabetes, lumbago. MVA 1999. Allergies:  keflex, levaquin, ASA, PCN.			1						1	Dizziness; Headache; Pyrexia	FLU3~SANOFI PASTEUR~U2467AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0294700	10/29/2007	PA	40.0	40		M	10/29/2007	On 10/25/07 pm started feel achy - high fever 102, next day aches fever continue 102 start muscle aches Saturday 10/27 - more pain trouble writing - Sunday 10/28 - couldn't walk toe - toe. Went to ED - when seen by physician peers felt like a turtle - couldn't roll over. 10/30/07-records received without DC Summary. Admitted 10/7/07-C/O 3 day history of increasing motor weakness associated with fever and diffuse myalgia. Flu shot received 5 days ago. Grip strength was significantly decreased, unable to life up a carton of orange juice. Fevers up to 102.9. Joint pain and ambulatory gait dysfunction. PE: generalized motor weakness significant decrease in grip strength, unable to lift legs more than 6 inches.  Also C/O photophobia, sore throat and headache and difficulty breathing, neck pain, joint pain, numbness and weakness. No rash. No dt changes or ascending in nature. HX of migraine like scotoma. Impression: viral syndrome. 10/31/07-DC Summary received: DC DX: Probably myositis, probably viral in orgin. Recent acute febrile illness. Per 60 day follow up report: Still gets intermittent tingling & numbness both hands & feet. Gets headaches weekly-did not have headaches before-had excessive fatigue-tested has lowered testosterone level. Continues to have. Annual follow-up Information 16-DEC-2008: Still having sig. muscle fatigue and weakness with numbness in foot.				Y	Y	1			U	10/23/2007	10/25/2007	2	CBC; CPK; ANA; Rh Factor; Lymes Disease 10/30/07-records received-CK elevated at 840, troponin negative, AST elevated at 58.	OTH	PVT	ADVAIR; COZAAR	None	ASTHMA; HTN 10-30/07-records received-PMH: hypertension and DJD, chronic intermittent insomnia, Denge fever and asthma.			1						1	Abasia; Antinuclear antibody; Blood creatine phosphokinase; Dyspnoea; Full blood count; Gait disturbance; Grip strength decreased; Hypokinesia; Lyme disease; Muscle fatigue; Myalgia; Myalgia; Pain; Paraesthesia; Pyrexia; Rheumatoid factor; Viral myositis	FLU3~SANOFI PASTEUR~U2527AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0294701	10/29/2007	MO	69.0	69		F	10/26/2007	Was given Pneumonia vaccine IM in RD on 10/22/07. Came back 10/23 with cellulitis from injection site down to mid forearm and elbow swollen hot and red. Area was marked and was told if it enlarged to go to ER, which she did. Was admitted. 11/5/07-records received for DOS 10/23-10/27/07-DC DX: Right arm cellulitis. Asthmatic bronchitis. Hyperlipidemia. Left forearm intravenous infiltration. Anxiety disorder. Seasonal allergic rhinitis. Evening after her injection developed pain redness and aching in right arm over the site of previous injection. Following morning noticed spreading erythema and pain in arm.					Y	4			U	10/22/2007	10/22/2007	0	See attached H & P and lab test office notes, and med list 11/5/07-records received-WBC 24.2, blood culture no growth.	PVT	PVT	Aspirin, Simvastatin, Zyrtec, Isosorbide, Astellin Nasal Spray, Spectracef	None	See attached records 11/5/07-records received-Anxiety disorder. Seasonal allergic rhinitis. Hyperlipidemia.			1						1	Injection site cellulitis; Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2464AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1035F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0294702	10/29/2007	WI	0.6	0	.6	F	10/22/2007	Severe vomiting, mild dehydration. Surgical consult, GI consult = neg findings.  11/19/2007 MR received for o/n observation 10/19-20/2007 with D/C DX: Emesis. Child presented to ER with 10-12 episodes of emesis over a 12 hour period.  Decreased po intake.  PE WNL. Surgery consult: surgical cause of emesis unlikely. No further emesis during admission.				Y	Y	1				10/18/2007	10/19/2007	1	WBC 17.9; Neutro pH 11,340; rest of CBC = negative. Labs and Diagnostics:  Upper GI with no evidence of malrotation. Mild delay in gastric emptying.  Abd US WNL. CBC with WBCs 17.9.	PVT	PVT		None	None. PMH: recent sinus infection.  NKDA.			1						1	Dehydration; Full blood count normal; Neutrophil count increased; Vomiting; White blood cell count increased	FLU3~SANOFI PASTEUR~U2449AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0294708	10/29/2007	IL	76.0	76		F	10/28/2007	Visual disturbances (black spots, blurry), lightheaded. Put head between legs for few minutes. Sxs resolved during 1 hour.									Y	10/28/2007	10/28/2007	0		OTH	PUB						1						1	Dizziness; Vision blurred; Visual disturbance	FLU3~SANOFI PASTEUR~U2514AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294709	10/29/2007	CA	30.0	30		F	10/23/2007	C/O dizziness that began 20 min after receiving vaccination.									Y	10/22/2007	10/22/2007	0	N/A	PUB	OTH	Yasmin	None	None			1						1	Dizziness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79489~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0294711	10/29/2007	AZ	52.0	52		F	10/24/2007	10:30 Sunday got shot. Almost 12 hrs later she got chills severe. She took Motrin every 4 hours. She had fever at night. It came back Monday. Every time she stopped taking Motrin the fever returned. It felt hot and sore and today is red and blotchy. The size of her palm.				Y					Y	10/21/2007	10/21/2007	0	doctor indicated cellulitis. She is on antibiotics. Much better now	PUB	PVT	Ventolin; Singulair;l Allegra; Levothyroxine	None	Allergies and asthma			1						1	Cellulitis; Chills; Erythema; Pyrexia; Rash macular; Skin warm	FLU3~SANOFI PASTEUR~U2453AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~0554U~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0294713	10/29/2007	KS	32.0	32		F	10/19/2007	Pt reports swelling and pain that hurts in neck and shoulder blade.									Y	10/18/2007	10/18/2007	0		PUB	PVT						1						1	Musculoskeletal pain; Neck pain; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA039AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0294714	10/29/2007	IL	70.0	70		F	10/22/2007	Patient received Fluzone and Pneumovax vaccines on 10/19/07. Patient informed us on 10/22/07 that she usually gets sick a little when she gets her flu shot, but starting 1-2 days after receiving vaccines, her normal temp of 97 went to 101, arm hurt, redness, pain down to palm of hand. She went to chiropractor for an adjustment and took APAP. Used ice.									N	10/19/2007	10/20/2007	1		UNK	UNK						1						1	Body temperature increased; Erythema; Pain in extremity	FLU3~SANOFI PASTEUR~U2528AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294717	10/29/2007	LA	42.0	42		F	10/19/2007	Within 24 hours after injection, pt reports redness and swelling about 2-3 fingers width wide - instructed cool compresses and Tylenol. 48 hrs after inject pt reports large amt redness, warmth and blistering at inj site. OV with MD - Rx for Augmentin on 3rd day.				Y						10/16/2007	10/17/2007	1		PVT	PVT		Afebrile URI	Asthma, HTN, Dyslipidemia			1						1	Erythema; Injection site erythema; Injection site swelling; Injection site vesicles; Injection site warmth	FLU3~SANOFI PASTEUR~U2442AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0962U~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294719	10/29/2007	MN	3.0	3		F	10/22/2007	Patient under the age of 18 was given the vaccine Fluarix.									U	10/16/2007	10/16/2007	0	N/A	PVT	PVT						1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0294724	10/29/2007	MN	9.0	9		F	10/22/2007	Wrong medication - pt. under the age of eighteen - was given Fluarix.										10/16/2007	10/16/2007	0	None	PVT	UNK	None	None	None			1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA311AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0294725	10/29/2007	MN	6.0	6		M	10/18/2007	Patient under the age of 18 was given the vaccine Fluarix.										10/16/2007	10/16/2007	0	N/A	PVT	PVT		None	Down Syndrome			1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA311U9~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0294726	10/29/2007	OH	69.0	69		M	10/23/2007	Friday felt bad with fatigue, muscle aches and felt cold worsened Saturday and Sunday. Had sore throat, nasal drip, watery eyes and temp was 101. Saw physician 10/16/08. Given penicillin parenterally and P.O. + B12 injection and cough med. Off work until 10/18/07. Still on oral PCN and still tired. As of 10-23-07				Y					Y	10/08/2007	10/12/2007	4	None	PUB	PUB	Thyroid medication and pain med	None	arthritis, hypothyroidism			1						1	Body temperature increased; Fatigue; Feeling abnormal; Feeling cold; Lacrimation increased; Myalgia; Pharyngolaryngeal pain; Rhinorrhoea	FLU3~SANOFI PASTEUR~U2465AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294727	10/29/2007	MN	3.0	3		F		Pale and behavior changes w/n 4 hours of flu shot - lasted about 1 hour.									Y	10/10/2007	10/10/2007	0		PVT	UNK						1						1	Abnormal behaviour; Pallor	FLU3~SANOFI PASTEUR~U2442AA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294730	10/29/2007	CO	53.0	53		M		Dizziness for 2-3 days after shot.									Y	10/13/2007	10/14/2007	1		OTH	OTH	None	None	None			1						1	Dizziness	FLU3~SANOFI PASTEUR~U2509AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294731	10/29/2007	AL	14.0	14		F	10/23/2007	Pain in (L) arm 2 days after vaccine, now entire body aches, muscle aches				Y					U	09/26/2007	09/27/2007	1	ANA 165-drawn on 9/28/07	PVT	PVT		None	None			1						1	Antinuclear antibody; Myalgia; Pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2461BA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1094U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0294732	10/29/2007	PA	76.0	76		F	10/19/2007	Patient complained of sore arm, throbbing pain from shoulder to elbow. Pharmacist advised patient to take Tylenol and ice the area and contact their physician. The injection site was not red or irritated and appeared normal									U	10/19/2007	10/19/2007	0		OTH	UNK		No				1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U252UAA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294733	10/29/2007	NJ	3.0	3		M	10/23/2007	(L) arm swollen, painful, hot to touch and patient had a fever. Keflex.									Y	10/19/2007	10/20/2007	1		PVT	PVT		URI	N/A			1						1	Oedema peripheral; Pain in extremity; Pyrexia; Skin warm	FLU3~SANOFI PASTEUR~U2526AA~5~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294736	10/29/2007	IA	66.0	66		F	10/18/2007	Injection site sore and red on evening of 10/16/07. Shoulder sore and red to elbow on morning of 10/17/07 so phone pharmacy. Advised to use Benadryl and reaction resolved over next 24 hours.									Y	10/16/2007	10/16/2007	0	None	OTH	PVT		None				1						1	Injection site erythema; Injection site pain; Musculoskeletal pain	FLU3~SANOFI PASTEUR~U2510AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0962U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294737	10/29/2007	MI	72.0	72		M	10/12/2007	Severe soreness, immobility for 1 week.									N	10/08/2007	10/09/2007	1		OTH	UNK		None	None			1						1	Injected limb mobility decreased; Pain	FLU3~SANOFI PASTEUR~U2500AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294738	10/29/2007	NV	63.0	63		F	10/19/2007	Pt reported pruritic rash resembling measles 48 hours after injection. Rash to torso/limbs with even distribution. Denies exposure to known allergens/any special other source. Tx with OTC Benadryl 12.5mg BID and Prilosec OTC QD x 5 d.									U	10/17/2007	10/19/2007	2	None	PVT	OTH		None	HTN, High chol, Asthma, O.A., Osteopenia			1						1	Rash morbilliform; Rash pruritic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80687~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0294740	10/29/2007	ID	32.0	32		F	10/19/2007	48 hr following flu vaccine-Both knees began to swell, warm-to-touch, stiff and were difficult to bend. Condition worsened over the next 2 days. 4th day Pt. was seen by physician. Dr. stated lab results indicated only inflammation.				Y					Y	10/09/2007	10/11/2007	2	Blood tests for Gout and R.A.- 4 Panel lab tests. All were negative.	PUB	OTH	Birth Control Pills	No	None			1						1	Joint stiffness; Joint swelling; Laboratory test normal; Rheumatoid factor negative; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA030AA~1~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0294744	10/29/2007	VA	16.0	16		F	10/23/2007	C/O + nausea, lightheadedness 4 after receiving injection. Placed in supine position, monitored vital signs and gave po fluids.									Y	10/23/2007	10/23/2007	0	None	PVT	PVT	None	None	NKDA			1						1	Dizziness; Nausea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80957~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HPV4~MERCK & CO. INC.~0525U~3~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0294745	10/29/2007	WV	86.0	86		F	10/22/2007	Pt received flu shot on 10/10/07, dev. nausea, vomiting and dizziness that day. Developed Bell's palsy on 10-13-07 as diagnosed by doctor. Pt no longer has N/V and getting PT for the B. Palsy per daughter who reported this event.11/6/07-records received for DOS 10/15/07-C/O not feeling well for 5 days, received flu vaccine on Wednesday and on Saturday started getting nauseated, mouth started drooping to right, speech is fairly clear. Some pain bilaterally in right ear. No problem with gait. PE: mouth drooping to right, right eyelid is weak especially upper eyelid. Furrow in the brow causes lower skin lines on right compared with left. EOM normal. Face sensation normal. Abdomen slightly tender to palpation. Impression: Bell's Palsy right, speech appears intact. Gastritis.				Y					N	10/10/2007	10/10/2007	0	Bell's Palsy	PUB	UNK	Furosemide; Enalapril; Glyburide	None	NIDM, CHF and HTN 11/6/07-records received-PHM: hyperlipidemia, old interior M, coronary artery disease, CHF, dementia, ataxia, DM, chronic renal insufficiency.			1						1	Dizziness; Facial palsy; Nausea; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA309CA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0294747	10/29/2007	TX	2.0	2	.3	M	10/23/2007	Fever to 104 for 48 hours after FluMist. Given antipyretics. Onset of fever 12 hours after vaccine given.									Y	10/13/2007	10/13/2007	0	None	PVT	PVT	None	None	Allergic rhinitis (seasonal)			1						1	Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500491~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0294748	10/29/2007	TX	41.0	41		F	10/23/2007	Pt states pain and burning going down arm to wrist and up to shoulder immediately upon receipt of inj. lasting 3 days. Entire upper arm area became swollen and reddened lasting 5 days. Deltoid area bruised.									Y	10/11/2007	10/11/2007	0	No	PUB	PVT	Atenolol 12.5mg daily	No	Codeine and Penicillin; Heart arrhythmia and pre-hypertension			1						1	Burning sensation; Contusion; Erythema; Oedema peripheral; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80435~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0294749	10/29/2007	ME	54.0	54		F	10/18/2007	Localized 3 1/2 cm round red hot raised area within 1 hr of shot - pounding headache - ecchymosis below injection site - head and neck pain. Developed GI upset, temp 99.9 for 24 hours - redness and ecchymosis remains at site 10/18/07. Other symptoms resolved.									Y	10/15/2007	10/15/2007	0	None	PUB	OTH		None	None			1						1	Abdominal discomfort; Body temperature increased; Ecchymosis; Headache; Injection site erythema; Injection site haemorrhage; Neck pain; Skin warm; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80957~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0294753	10/29/2007	AZ	4.0	4		F	10/17/2007	Pt had fever, fatigue and painful walking on leg x 2 days.									Y	10/12/2007	10/13/2007	1		PVT	PVT				Crying, vomiting~DTaP (no brand name)~3~0.60~In Patient		1						1	Fatigue; Gait disturbance; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2443AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0548~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0294754	10/29/2007	WI	72.0	72		F	10/24/2007	Rt deltoid painful, sore to touch and very painful with any movement									U	10/22/2007	10/23/2007	1	None	PVT	OTH		None	No known drug allergies, No B-defects, Etc			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U2450AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0380U~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294755	10/29/2007	WA	14.0	14		M	10/24/2007	No adverse effects. Pt was given expired influenza vaccine.									Y	10/23/2007				PVT	PUB			Asthma			1						1	Expired drug administered; Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70740~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0294756	10/29/2007	CA	13.0	13		F	10/29/2007	Per mother-red, egg size mark on arm (Lt deltoid area) starting the morning after her injections. Body ache and low grade fever (100-104) Mom started Benadry and Ibuprofen and ice to local area. Redness increased to nearly cover upper arm. See in ER 4 days after injection 2-4 hr sudden increased in redness. Started on Acithromycin and TMP/Sulfa-Today c/o abd discomfort and nausea. Still has body aches, redness decreasing in size.				Y						10/22/2007	10/23/2007	1	None	PVT	PVT	Singulair, Xopenex and Flovent 44-neither currently.	None	Asthma, Previous hx of Pneumovax x's 2			1						1	Discomfort; Injection site erythema; Nausea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2440AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0929U~2~UN~LA~HPV (GARDASIL)~1|PPV~MERCK & CO. INC.~0889F~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0294758	10/29/2007	TX	45.0	45		F	10/29/2007	Noted palm size red swollen area to inner upper arm region above elbow. Per patient area that is red has moved down from upper deltoid region where injection was given. Pt told to take Tylenol, Benadryl, cold compresses.									Y	10/26/2007	10/26/2007	0	None	PUB	UNK	Hydroclorathyride; Setrol		High blood pressure		TX0797	1						1	Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~U2478AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0601F~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294759	10/29/2007	MI	82.0	82		F	10/15/2007	Administered Fluarix in left arm. Took needle out and arm began swelling in egg shape, hard mass. Applied ice pack, gave Benadryl 50 mg capsule. Swelling was the only sign of adverse reaction.									Y	10/15/2007	10/15/2007	0	None	PUB	OTH		eye infection	None			1						1	Injection site induration; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA317AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0294760	10/29/2007	MN	5.0	5		M	10/29/2007	Red, warm, tender, swollen (L) deltoid began < 12 hrs after vaccination.										10/25/2007	10/25/2007	0		PVT	PVT		None	None			1						1	Erythema; Oedema peripheral; Skin warm; Tenderness	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B051AA~5~UN~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2462BA~3~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0170~4~UN~LA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0294761	10/29/2007	PA	3.0	30		F	10/29/2007	Had Adacel 10/22 - on 10/27 developed pain and redness around vaccine site - now with 6cm no induration -									Y	10/22/2007	10/22/2007	0		UNK	UNK		None	None			1						1	Inappropriate schedule of drug administration; Injection site erythema; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA300AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|TDAP~SANOFI PASTEUR~C2962AA~1~UN~LA~TDAP (ADACEL)~1	USA		Influenza
0294762	10/29/2007	NY	26.0	26		F	10/29/2007	Severe headache, fever, hives near injection site, fatigue									N	10/26/2007				PVT	UNK		None	PCN; Septra			1						1	Fatigue; Headache; Injection site urticaria; Pyrexia	FLU3~SANOFI PASTEUR~U2467AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0038U~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294764	10/29/2007	NY	62.0	62		F	10/25/2007	Facial swelling, eye edema, excessive salivation seen in ER - ? allergic reaction to flu vaccine given Benadryl/ Solumedrol				Y						10/24/2007	10/25/2007	1		OTH	OTH						1						1	Eye oedema; Salivary hypersecretion; Swelling face	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80687~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0294765	10/29/2007	IN	39.0	39		F	10/11/2007	Angioedema right upper extremity, syncope, cellulitis				Y					Y	10/10/2007	10/10/2007	0		PVT	PVT	COUMADIN; B12; VITAMIN B; MVI; LAMICTAL; CITRACEL; ELAVIL; CHANTIX	None	Protein S +C; PCOS; Hyperlipidemia; seizure disorder; sulfa; PCN; adhesive			1						1	Angioedema; Cellulitis; Syncope	FLU3~SANOFI PASTEUR~42442aa~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~09910~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0293855	10/30/2007	NY	25.0	25		F	10/30/2007	patient first developed flu-like symptoms which developed into neurological, bi-lateral burning all over my body. The burning localized in the legs. There was a progression of burning, ant-like sensatations, Tingling, bubbling in the skin. Could not walk,stand , or sit for prolonged periods of time. eventually I was diagnosed with Guillian Barr syndrome, Myelopathy,Fibromyalgia, Myofacial disorder.								Y	N	03/17/1991	03/17/1991	0	whole body bone scans, nuclear scans, Electroencephalograms, Emg's, Myelogram-causing anaphalic shock, whole body MRIs', EKG's, nerve conduction studies.	PUB	UNK	none	none	none	none~ ()~NULL~~In Patient|none~ ()~NULL~~In Sibling1|none~ ()~NULL~~In Sibling2		1						2	Amnesia; Anaphylactic shock; Anxiety; Arthroscopic surgery; Burning sensation; Computerised tomogram; Contusion; Crying; Cyanosis; Deafness; Depression; Dysaesthesia; Dyspnoea; Electrocardiogram; Electrocardiogram ambulatory; Electroencephalogram; Electromyogram; Fall; Fibromyalgia; Formication; Gait disturbance; Gallbladder operation; Influenza like illness; Lumbar puncture; Multiple sclerosis; Myelopathy; Nerve conduction studies; Nuclear magnetic resonance imaging; Pain; Pain in extremity; Palpitations; Panic attack; Paraesthesia; Radiculopathy; Spinal myelogram; Surgery; Syncope; Ultrasound scan; Walking aid user; Weight increased; X-ray; Abasia; Anaphylactic shock; Bone scan; Burning sensation; Electrocardiogram; Electroencephalogram; Electromyogram; Fibromyalgia; Formication; Influenza like illness; Myelopathy; Myofascial pain syndrome; Nerve conduction studies; Neurological symptom; Nuclear magnetic resonance imaging; Paraesthesia; Spinal myelogram	FLUX~UNKNOWN MANUFACTURER~?~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~MERCK & CO. INC.~?~1~IM~RA~HEP B (RECOMBIVAX HB)~1|MMRV~MERCK & CO. INC.~?~1~IM~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|FLU3~PFIZER\WYETH~at hospital~2~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~2|HEP~MERCK & CO. INC.~at hospital~3~IM~RA~HEP B (RECOMBIVAX HB)~2|MMR~MERCK & CO. INC.~at hospital~2~IM~LA~MEASLES + MUMPS + RUBELLA (MMR II)~2	USA	Disabling	Influenza
0294706	10/30/2007	KS	56.0	56		F	10/30/2007	Given flu shot at approx 3:30 PM on 10/26/07. By 7:30 PM felt  different. Within 10 minutes in bed with chills and oncontrollable shaking, aches, muscle cramps. This lasted for 5 hours. Next day muscle weakness and still feeling out of sorts. Feeling better by Sunday 10/28.										10/26/2007	10/26/2007	0		PUB	PVT	Coreg 25 mg, Mavik 2 mg, Baby Aspirin 80 mg.	None	High Blood Pressure			1						1	Chills; Feeling abnormal; Muscle spasms; Muscular weakness; Pain; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0294802	10/30/2007	FL	1.25	1	.3	M	10/30/2007	Developed fever 102.4 last night and rash on abdomen, neck, back and buttocks. Mother gave motrin and tylenol per pcp's instructions. Taking to pcp today.				Y					U	10/29/2007	10/29/2007	0		PUB	PUB		Denied.	None.			1						1	Pyrexia; Rash	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B046AA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2474AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~1192R~3~IM~RL~HIB + HEP B (COMVAX)~1|IPV~SANOFI PASTEUR~Z0872-2~3~SC~RA~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0294804	10/30/2007	GA	38.0	38		F	10/30/2007	water blister at injection site about 1cm diameter, warm to touch x 2 days about 1 inch diameter area, No Fever.									N	10/26/2007	10/27/2007	1		UNK	PVT						1						1	Injection site vesicles; Skin warm	FLU3~SANOFI PASTEUR~U2492AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294810	10/30/2007	WI	3.0	3		M	10/30/2007	Parent noticed a 2 inch area of redness around injection site on 10/26/07.  Instructed to mark edges of red area, use cool compress, Tylenol, Benadryl as needed and monitor area over weekend and see MD if symptoms worsen.  On 10/27/07 parent noted red area had doubled in size to 4 inches and was hard and warm to touch.  Child taken to Urgent Care and diagnosed with cellulitis and given Cephalexin 250 mg. TID.  Today (10/30/07), area of redness is fading, but a 25 cent size bruise has developed at injection site.				Y					Y	10/25/2007			None	PUB	PUB		None	None per paremt			1						1	Cellulitis; Cold compress therapy; Injection site bruising; Injection site erythema; Injection site induration; Skin warm	FLU3~SANOFI PASTEUR~U2523AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294811	10/30/2007	MA	44.0	44		F	10/30/2007	symptoms: swelling, redness, itchy, fever, pain - all at injection site.									U	10/26/2007	10/26/2007	0		PVT	PVT		None				1						1	Injection site erythema; Injection site pain; Injection site pruritus; Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~5~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0294812	10/30/2007	FL	2.0	2	.1	F	10/21/2007	None stated 11/9/07-records received for DOS 10/20-10/23/07- DC DX: Fever resolved. Possible adverse reaction to immunization resolved. Leukocytosis, resolved. Bilateral otitis medica resolving. Admitted with high grade fever 104, 48 hours after administration of vaccines. Erythema and swelling at injection site.					Y	3			Y	10/18/2007	10/19/2007	1	Increased WBC; Increased CRP; All cultures negative; WBC later negative. 11/9/07records received-WBC 33,000, CRP 7.5, blood cultures negative, RSV,negative, CXR negative.	PVT	PUB	ALBUTEROL; PROVENTIL; SINGULAIR	Otitis	IgG subclass 4 deficiency; RAD			1						1	C-reactive protein increased; Culture negative; White blood cell count increased	FLU3~SANOFI PASTEUR~UT2659NA~3~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0556U~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0294813	10/30/2007	ND	38.0	38		F	10/25/2007	Fever, chills, erythema, heat and swelling right upper arm.  11/13/2007 MR received for DOS 10/23-24/2007 with D/C Dx of Allergic Reaction to immunization with mostly local allergic reaction.  Temperature spike. Pt presented to ER with severe pain, heat and swelling in the R arm where flu and pnuemo vax given. Was given abx and d/c.  Later in the day she presented again with high fever, sweats and chills. T=104.2 after Tylenol and Motrin.  PE (+) for H/A, joint and back aches,  and R arm erythema, swelling and pain. (+) dehydration as well. Txd with abx, steroids, IVF and antihistamines with improvement. F/U appt 10/25 with pt feeling much better.					Y	1			Y	10/22/2007	10/24/2007	2		PVT	PVT	BCP		PCN; BACTRIM; DIVERTICULITIS; ANXIETY. PMH: Diverticulosis, hemorrhoids.  Allergies:  PCN, Bactrim. Antivert causes arthralgias.		0714	1						1	Chills; Erythema; Oedema peripheral; Pyrexia; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80682~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0883F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0294814	10/30/2007	CO	61.0	61		M	10/27/2007	Pt. was given influenza vaccine and had allergic reaction 45-60 min later Rash noted around neck, all over back. Rash was red and warm to touch.									Y	10/27/2007	10/27/2007	0	None	OTH	PVT	unsure (one for prostate, one for cholesterol)	None	Sulfa, Iodine, Shellfish			1						1	Erythema; Hypersensitivity; Rash; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78481~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0294815	10/30/2007	IA	59.0	59		F	10/29/2007	Swollen arm at injection site, lump at injection site. Chills, fever during night after administration. Didn't improve until Mon 10/28 - swelling started to return to arm 10/29.									Y	10/25/2007	10/25/2007	0		OTH	PVT	Atenolol; Pepcid	None	Blood pressure			1						1	Chills; Injection site mass; Injection site swelling; Oedema peripheral; Pyrexia	FLU3~SANOFI PASTEUR~U2487AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294816	10/30/2007	MI	70.0	70		F	10/30/2007	received Flu shot on 10/25/07 came in store on 10/28/07 to report reaction from flu shot. Skin reaction and welts on lower part of arm									Y	10/25/2007	10/27/2007	2		OTH	UNK						1						1	Skin reaction; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA299EA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0294817	10/30/2007	NY	64.0	64		M	10/30/2007	Recurrent xerosis and post-inflammatory hyperpigmentation (Dx 08/06/07)				Y					Y	10/04/2007				PUB	OTH	Omeprazole, fluxatin, HCTZ, Motrin, Baclofen	spinal stenosis, Xerocin, HTN, PTSD				1						1	Post inflammatory pigmentation change; Xerosis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80061~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0294818	10/30/2007	AZ	55.0	55		F	10/30/2007	Patient said she had severe and violent chills the night of the day she got the flu shot. She also had pain all over her body and muscle. violent chills									Y	10/27/2007	10/27/2007	0		PUB	PVT						1						1	Chills; Myalgia; Pain	FLU3~SANOFI PASTEUR~U2453AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294819	10/30/2007	KY	72.0	72		F	10/30/2007	pt states that she had unusual rash after receiving Pneumo shot. Rash underneath arm, not at injection site. Status getting better but wanted us to be informed									Y	10/24/2007	10/25/2007	1	None	PVT	UNK		None	None			1						1	Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA31AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0804U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294821	10/30/2007	MD	69.0	69		M	10/29/2007	Patient received Zostavax vaccine 10-15-07. Was seen in office 10-22-07, 10-25-07 for other medical symptoms, no report of difficulty from vaccine. On 10-29-07, pt. seen in our office for c/o rash @ (L) waistline, has L L2 dermatome red patches, vesicles. Was started on Valtrex 1.0gm tid, Vicodin, and tapering prednisone, to be f/u in 2 days.										10/15/2007	10/26/2007	11	None	PVT	PVT	Toprol, Plavix, Imdur, Diovan, Vytorin, MVI Omega 3, Indocin, Allopurinol ASA	Inguinal hernia	NKDA			1						1	Rash macular; Rash vesicular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78990~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARZOS~MERCK & CO. INC.~0884Z~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0294822	10/30/2007	NC	37.0	37		F	10/30/2007	Marked erythema of the injection site with confluent erythema of the upper chest and neck and upper extremities, moderate warmth, elevated BP; intense itching all over.				Y					Y	10/29/2007	10/29/2007	0		UNK	UNK	None	None	None			1						1	Blood pressure increased; Erythema; Injection site erythema; Pruritus generalised; Skin warm	FLU3~SANOFI PASTEUR~U2491AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294823	10/30/2007	MA	49.0			F	10/30/2007	Immediate large baseball size welt at injection site. Lasted several days. No known sensitivity to eggs or Thimerosal.									Y	10/22/2007	10/22/2007	0	None	PUB	PVT	None	None	None			1						1	Injection site reaction; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80435~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0294824	10/30/2007	CA				F		patient complained of itchiness on arm about 10 minutes after shot was given in the same arm. pt was assessed and given 0.3 cc of 1:1000 Epinephrine chloride subcutaneously in the opposite arm. patient's itchiness was relieved.									Y	10/24/2007	10/24/2007	0		UNK	UNK		None				1						1	Pruritus	FLU3~SANOFI PASTEUR~U2449AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294825	10/30/2007	IA	51.0	51		F	10/29/2007	Redness about an hour after injection-pain for 7 days Redness was about 2 x 1/2 . There was a line that appeared to be a broken vessell near site. Hot to touch for 5 days and had a hard knot Took Benadryl and Ibuprofen first 2 days and ice pack									Y	10/22/2007	10/22/2007	0	None	PVT	PVT	Lipitor 20 mg, Zbaby aspirin/day Milk thistle, multivitamin	None	Sulfa 3rd degree heart block (pacemaker) lobular carcinoma			1						1	Erythema; Induration; Pain; Skin warm	FLU3~SANOFI PASTEUR~U2442AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294826	10/30/2007	SD	80.0	80		F	10/30/2007	flu shot in (L) arm on 10/24/07 and on 10/26/07 developed pain, developed warmth, redness 10x5.5 cm irregular shape area in left elbow. Received medication to relieve pain and observation. Stated she has never had any reaction previously to an flu shot.										10/24/2007	10/26/2007	2		OTH	PVT			Essential hypertension, Osteoarthritis, Depression			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ARUA302AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0294827	10/30/2007	IA	36.0	36		F	10/30/2007	Received flu shot for first time Within 5 minutes had numbness from tip of tongue back to mid-line of tongue. Developed warmth and achiness to deltoid/injetion site. Numbness in tongue lasted 4 days. Inj. site irritation lasted x 6 days.									Y	10/23/2007	10/23/2007	0		PVT	PVT						1						1	Hypoaesthesia oral; Injection site irritation; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U2528AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0294828	10/30/2007	MI	26.0	26		F	10/30/2007	Shot given 10/10/07. On 10/11/07 seen for swelling in (L) arm. Had facial swelling on 10/18/07 - placed on Prednisone and Clarinex 5mg. Symptoms resolved after that. Yeast infection (vaginal) by 10/30/07. Placed on Keflex and Benadryl.									Y	10/10/2007	10/10/2007	0	None	OTH	UNK	None	No	Asthma, Pneumonia, Allergic rhinitis			1						1	Fungal infection; Swelling face	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80435~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0294829	10/30/2007	MI	25.0	25		F	10/12/2007	Flu vaccine administered on 10/10/07 about 5:00 PM. 1st noticed swelling on 10/12/07. Had pain beginning evening of vaccine. Has had facial flushing off and on since administration.									Y	10/10/2007	10/10/2007	0	None	OTH	PVT	Cymbalta; Yasmin; Ibuprofen	No	Milk allergies	9/7/07~Hep B (no brand name)~2~25.00~In Patient		1						1	Flushing; Pain; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80435~1~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0294830	10/30/2007	CA	70.0	70		F	10/26/2007	Rec'd flu shot and Pneumovax 10/24/07. Fever 10/24 to 100.5, body aches. Fever to 102 on 10/26, some HA and nausea. Symptoms resolved by 10/28/07.									Y	10/24/2007	10/24/2007	0	UA - no evidence of infection	UNK	UNK			IBS, HTN, Urinary incontinence			1						1	Headache; Nausea; Pain; Pyrexia; Urine analysis normal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80682~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0961U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294833	10/30/2007	CA	53.0	53		M	10/18/2007	Patient reports onset shaking, chills I couldn't hold a glass of water and teeth chattering approx 9 pm. 4 AM (beginning the evening after both influenza and Pneumovax injections.) With assoc subjective fever and myalgias. Now resolved all but myalgias. No tx, pt afebrile. VSS on 10/16/07.									Y	10/15/2007	10/15/2007	0	None	OTH	PUB	Metformin, Atenolol, Seroquel, Remeron	None	HTN, DM 2			1						1	Chills; Myalgia; Pyrexia; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA312BA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0964U~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294834	10/30/2007	TX	60.0	60		F	10/25/2007	Given Flumist. 15-20 min later c/o dizziness and tachycardia. Mom went to ER. Vital signs normal and was feeling better by time was seen.				Y					Y	10/24/2007	10/24/2007	0	None	PVT	UNK		No	None			1						1	Dizziness; Inappropriate schedule of drug administration; Tachycardia	FLUN3~MEDIMMUNE VACCINES, INC.~500488p~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0294835	10/30/2007	MT	10.0	10		F	10/25/2007	Patient's mother reports 3 x 4 cm red oval raised area on back of right arm in area of VZV vaccine given 10/19/07. No other problems reported									Y	10/19/2007	10/20/2007	1		PUB	PUB	None reported	None reported	None reported			1						1	Erythema; Swelling	FLU3~SANOFI PASTEUR~U2490AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0802U~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2420AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~12704~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0294836	10/30/2007	DC	31.0	34		F	10/26/2007	Flu-like symptoms for 24 hours after vaccination; swollen lips, numbness; red puffy eyes									Y	10/17/2007	10/17/2007	0	None	PVT	PVT	None	None	None			1						1	Eye swelling; Hypoaesthesia; Influenza like illness; Lip swelling; Ocular hyperaemia	FLU3~SANOFI PASTEUR~U2462AA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB432AA~2~UN~UN~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHBVB432AA~2~UN~UN~HEP A (HAVRIX)~1	USA		Influenza
0294837	10/30/2007	CA	67.0	67		M		Extreme wheezing, extreme chills, face hot burning weakness and aches used Proair - HFA (Albuterol sulfate) and I took 1 non-aspirin acetaminophen caplet and 500mg fell asleep immediately. I don't know if I was exposed to the flu before or if I had reaction to the vaccine. Because during the injection some of the fluid ran down my arm. The following day after the attack -10-19-07 I phoned VAERS - I was told to contact my health provider - contacted 10-19 message center 3 times. After six hours and on my third message I received a response on 10-22-07 had the vaccination read on and its 10-25-07 with no negative reaction. I still have minimal wheezing from the first reaction.									Y	10/15/2007	10/17/2007	2		OTH	UNK		None	Asthma			1						1	Asthenia; Burning sensation; Chills; Pain; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0294838	10/30/2007	LA	81.0	81		F	10/25/2007	Pain in affected arm; persistent.  To whom it may concern, I reacently filed report with you on this pt.  Pt did not have reaction to vaccine she has been diagnosed with shingles.  Any questions feel free to call me.									Y	10/01/2007	10/21/2007	20		PVT	PVT	See medication sheet		Antihistamine; Allegra-D; Altace; Flomax			1						1	Herpes zoster; Pain in extremity	FLU3~SANOFI PASTEUR~42442AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~006111~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294839	10/30/2007	NM	3.0	3		M	10/22/2007	Approx 4-5 minutes after receiving Flu vaccine injection, patient told Grandma he couldn't breathe and he wanted her to breathe on him. He spit his gum her hair and because more limp on her shoulder. She summoned help - office staff immediately in room. Patient pale, spit up small - moderate amount thick clear mucous with blue (gum was blue). Patient never lost consciousness, but was pale, RR ~24, HR 60's. Placed on left side on table, O2 4L administered per NC, O2 Sat monitor on finger (O2 Sat 100% HR 70). Both clinic doctor summoned at present. Evaluated patient, breath sounds clear and equal, HR regular. O2 administered ~10-15 minutes, Sat remained 100. HR 70-90's. After ~25 minutes, patient sat up (O2 Sat 98 in RA, HR 92). Took sips H2O and retained. Mom present as well as Grandma. Patient standing, taking few steps 96.8 after ~ 1 hour. Breath sounds remain clear, RR 32, HR 90. After approximately 1 hr, left office with mom and Grandma with instructions to continue observing patient and go to ER if untoward symptoms arise. Of note is that Grandma states that she faints with injections and that patient's 10 year old sibling almost fainted after injection a couple of weeks ago. Patient went into ER later the afternoon of 10/19/07. ER doctor evaluated patient and pronounces him OK, mom states. Today, 10/22/07, mom states patient is totally well and returned to normal. Mom is aware that VAERS report is being filed.				Y					Y	10/19/2007	10/19/2007	0	None	PVT	PUB	None	None	None Known			1						1	Cyanosis; Dyspnoea; Heart rate decreased; Hypotonia; Pallor; Vomiting	FLU3~SANOFI PASTEUR~U2509AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294841	10/30/2007	GA	63.0	63		M	10/30/2007	LOCAL ERYTHEMA AND PAIN,  MANAGED WITH IBUPROFEN AND COLD COMPRESSES									Y	09/27/2007	09/28/2007	1	nONE	UNK	UNK	ATRIPLA, LABETALOL, LISINOPRIL, LOPERAMIDE, LORATIDINE, FLUVASTATIN, NIFEDIPINE, CLONAZEPAM, CODEINE	R ELBOW ARTHRITIS/BURSITIS	HIV, HTN, GLAUCOMA, ALCOHOL ABUSE			1						1	Cold compress therapy; Erythema; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA294FA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1084U~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294842	10/30/2007	MI	77.0	77		M	10/30/2007	1 week after administration found dead at home. History of COPD and squamous cell lung cancer RUL with obstruction of airway and s/p palliative treatment. Daughter felt he became more lethargic 24 hours after vaccination and requested we report this. No autopsy performed by medical examiner and death certificate pending.  11/27/07 Reviewed death certificate which states COD as right lung pancoast tumor due to chronic obstructive pulmonary disease. 1/4/08 Reviewed medical records which reveal patient experienced cough, recurrent RUL infections which responded to antibiotic tx, RUE pain s/p brachial plexus involvement, poor appetite on 10/18/07.  Dx w/RUL lung Pancoast squamous cell carcinoma, stage B & tx w/chemo & radiation tx.	Y	10/24/2007							N	10/18/2007	10/24/2007	6	none	UNK	UNK	restoril 30 mg q HS, avadart 1  qD, ASA 81 mg q day, remeron 45 mg q HS, oxycodone ER 20 mg bid, magic cup 1-2 q day (nutritional supp given by oncology)deptestosterone 200 mcg IM biweekly, augmentin 875 mg bid	lung ca rul, chronic pneumonia rul due to partial obstruction	HTN, COPD, CAD, RUL lung CA, depression PMH: HTN, CAD, RUL SCCA of lung.			1						1	Death; Lethargy	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA294CA~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Results in Death	Influenza
0294844	10/30/2007	CA	32.0	32		F	10/30/2007	SUBJECTIVE: Patient is a 32 Y female presenting for first visit with provider after transfer of care from Dr. to me with concerns of reaction to flu vaccine. States she received flu vaccine at 1:30pm yesterday at a pharmacy and then she developed symptoms at 10:00pm before bed that involved coughing and dyspnea and chest tightness and wheezing, hives on chest.  Took some benadryl and was able to lie down and then felt hot and chilled.  NO temp taken but she felt sweaty. Today she feels fatigued and achey.  Denies a history of asthma but gets allergies.  No recent URI or allergy symptoms the past few days, gets allergies in the spring and summer. No prior adverse events reported.  No history of egg allergy.  Pt had no symptoms today and appears well so no treatment was given.   Attempted to contact the vaccine administrator and was transferred to voice mail where a message was left indicating pt's name and reaction and my intent to file VAERS report.  I do not have any of the information on what brand or lot number was given.				Y					Y	10/29/2007	10/29/2007	0	none	UNK	UNK	Zovia	none	allergic rhinitis, anxiety with air travel			1						1	Chest discomfort; Chills; Cough; Dyspnoea; Fatigue; Feeling of body temperature change; Hyperhidrosis; Pain; Urticaria; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0294847	10/30/2007	MS	50.0	50		F	10/15/2007	R ARM PNEUMONI VACCINE SQ R ARM 10/11/07; PT STATE S/S BEGAN 10/12/07 WHICH INCLUDED SEVER HEADACHE, FEVER, CHILLS, RIGHT ARM EDEMA, REDENSS, AND WARMTH. ALSO HAD FLU VACCINE R DELTOID @ SAME TIME/DAY. PLANS TO GO TO PMD TODAY									N	10/11/2007	10/12/2007	1	NONE	PUB	PVT					MS07028	1						1	Chills; Erythema; Headache; Oedema; Pyrexia; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFUA2820A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0354U~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294848	10/30/2007	MA	86.0	86		F	10/30/2007	patient was not acutely ill but was found dead in her chair within 24 hours of flu vaccine.   1/15/08 Death certificate states COD as acute myocardial infarction w/chronic ischemic heart disease as contributing factor.	Y	10/29/2007							N	10/28/2007	10/29/2007	1	lot # aflla062aa	UNK	UNK	omeprazol 20 mg daily, Zyprexa 2.5mg evening, ativan 0.25mg po twice daily, remeron 15mg po qhs	See # 19.	chronic ischemic heart disease. HTN, depression, A-fib. no known allergies. 11/2/07 Received medical records from reporter which reveal patient experienced a PMH: anxiety, depression, dementia, recurrent UTIs, CAD, atrial fib, MI, cataracts.			1						1	Death	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA062AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Results in Death	Influenza
0294850	10/30/2007	MA	85.0	85		M	10/30/2007	Patient found dead in his chair 36 hours after vaccine.  Had not been acutely ill prior to vaccination.  11/02/07 Received medical records from reporter which reveal patient w/extensive medical hx.  H&P of 5/07 indicates had recent diarrhea, apple core lesion in mid to distal sigmoid colon, severe dementia, SOB & extremely poor appetite who had been admitted to hospital then transferred to LTC due to lethargy, fatigue & falls.  Had cellulitis &  inflammation of lower leg but afebrile on day of vax.  Next day had congested productive cough w/green phlegm & vomiting. 10/28 had increased congestion, unresponsive w/dusky color.  BP 89/66 & placed on O2 due to sats of 50-60%.  Taken to hospital. 11/16/07 Received hospital ER medical records of 10/28/2007. FINAL ER DX: respiratory failure, sepsis Records reveal patient experienced fever, lethargy altered mental status & abdominal guarding. Exam revealed bilateral diffuse rhonchi, increased respiratory rate, diffuse abdominal tenderness & guarding, decreased bowel sounds, pitting edema of LE's & tachycardia, temp 101.3.  Patient was DNR & comfort measures provided until expiration.  ME declined case.	Y	10/28/2007							N	10/26/2007	10/28/2007	2	LABS: Sodium 131, BUN 45, creatinine 2.9.  CXR pulmonary edema.  KUB distended bowel loops.  Amylase 108, lipase 31	UNK	UNK	atenolol 12.5mg po daily, HCTZ 12.5mg po daily, omeprazole 20mg daily, glyberide 5mg twice daily, aggrenox sa 1 cap twice daily, hydralizine 10mg four times daily, lipator 20mg every pm, lasix 40mg daily. remeron 15mg po in pm, namenda 10 m	see # 19.	diabetes, HTN, SDAT, collitis  PMH:  Alzheimer's, lipid disorder, BPH, TURP, prostate cancer, polypectomy, HTN, DM, bowel neoplasm, CVA 2004 requiring craniotomy & evacuation, CHF, ejection fraction 60% in 2003, first degree AV blockdiverticulosis, side branch IPMN, prostate cancer.			1						1	Death	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA062AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Results in Death	Influenza
0294851	10/30/2007	CA	1.25	0	.3	M	10/30/2007	Received MMR, varicella, DTap, influenza vaccine 10/16/07.  Fever above 101 10/23-10/25.  Developed a classic febrile seizure 10/25.  Seen in ED 10/25/07.				Y					Y	10/16/2007	10/25/2007	9	CXR, cbc, urine culture, blood culture normal.	PVT	PVT		None.	None.			1						1	Blood culture negative; Chest X-ray normal; Culture urine negative; Febrile convulsion; Full blood count normal; Pyrexia	DTAP~SANOFI PASTEUR~C2657AA~4~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2456DA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0749U~1~IM~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1246U~1~IM~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0294853	10/30/2007	WA	65.0	65		M	10/30/2007	WAS GIVEN FLU SHOT & PNEUMOCOCCAL VACCINE AT A CLINIC STAFFED BY STUDENT NURSES.  VACCINES WERE GIVEN IN THE SAME ARM.  THE NEXT DAY THE ARM WAS SWOLLEN, RED & HOT TO THE TOUCH.  2ND DAY PATIENT COMPLAINED OF FEELING VERY ILL - LETHARGIC, FEVER, MALAISE.  BY DAY 3, THE PATIENT HAD FULLY RECOVERED									Y	10/25/2007	10/26/2007	1	NONE	UNK	UNK	UNKNOWN	NONE	NONE			1						1	Erythema; Lethargy; Malaise; Oedema peripheral; Pyrexia; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA294DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0697U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0294854	10/30/2007	OH	67.0	67		F	10/30/2007	Wheel noted left arm 1 inch below injection site.  Area erythema, elevation of skin noted with white center.  Advised patient to monitor.				Y					Y	09/25/2007			n/a	PVT	PVT			copd			1						1	Erythema; Swelling; Urticaria	FLU3~SANOFI PASTEUR~U2487AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0294855	10/30/2007	TX	51.0	51		F	10/30/2007	pT. GOT THE FLU VACCINE AND 48 HOURS THE LEFT ARM STARTED TO SWELL INCLUDING THE SOFT TISSUE AROUND THE NECK. AREA WAS SWOLLEN, SLIGHTLY WARM AND ONE LYMPHADENOPATHY.									Y	10/26/2007	10/28/2007	2		PUB	PUB	zETIA, 10 MGS p.o. q. dAY	NONE				1						1	Local swelling; Lymphadenopathy; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U2452AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0292561	10/31/2007	SC	0.5			M	10/30/2007	Information has been received from a physician concerning a 6 month old male who on approximately 01-OCT-2007 was vaccinated p.o. with a 2 mL dose of Rotateq. Concomitant therapy included routine 6-months vaccinations. On approximately 04-OCT-2007 the patient experienced profuse vomiting and was hospitalized. Diagnostic studies performed included an ultrasound which indicated that the infant had intussusception. Dates the infant was hospitalized and the vaccine lot number were not reported. Unspecified medical attention was sought. The outcome is reported as recovered. There was no product quality complaint. Additional information has been requested.				Y	Y	0	Y		Y	10/01/2007	10/04/2007	3	diagnostic laboratory - ultrasound indicated IT	OTH	OTH			Unknown		WAES0710USA04359	1						2	Abdominal X-ray; Intussusception; Urinary system X-ray; Intussusception; Ultrasound scan abnormal; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B115CB~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2435AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF119AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B47300F~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0410U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1|RV5~MERCK & CO. INC.~~UNK~PO~MO~ROTAVIRUS (ROTATEQ)~2|UNK~UNKNOWN MANUFACTURER~~UNK~UN~UN~VACCINE NOT SPECIFIED (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0292631	10/31/2007	NV	73.0	73		M	10/31/2007	rash on right arm from elbow to shoulder. 103.7 fever. given Levaquin 750MG Tablets for 10 days.   I still have a runny nose,but no fever				Y					N	10/03/2007	10/04/2007	1		PUB	PVT	on the 2nd of Oct I had a Gamma Goblin infusion	none				1						2	Blood test; Body temperature increased; Chills; Injection site erythema; Injection site pain; Insomnia; Pyrexia; Rash; Rhinorrhoea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~afua294fa~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0962U~1~IM~RA~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~0618U~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~~UNK~IM~~PNEUMO (NO BRAND NAME)~2|VARZOS~MERCK & CO. INC.~~UNK~IM~~ZOSTER LIVE (ZOSTAVAX)~2	USA	Emergency room visit	Influenza
0293506	10/31/2007	LA	44.0	44		F	10/31/2007	Pt. developed low grade temp, achy all over, wheezing flare up. Pt. saw primary care to treat symptoms not Dr.				Y					U	10/15/2007	10/15/2007	0	None	PVT	PVT						1						2	Asthenia; Body temperature increased; Dizziness; Dysphonia; Injection site erythema; Injection site pain; Injection site swelling; Pain; Pharyngolaryngeal pain; Body temperature decreased; Pain; Wheezing	FLUX~UNKNOWN MANUFACTURER~clinic will not~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U2486AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0294861	10/31/2007	MI	44.0	44		F	10/31/2007	NAUSEA,   MUSCLE ACHE (BOTH STARTED APPROXIMATELY 30 HOURS AFTER SHOT GIVEN)									Y	10/29/2007	10/30/2007	1		PUB	UNK						1						1	Myalgia; Nausea	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0294983	10/31/2007		16.0			F	10/30/2007	Information has been received from a nurse practitioner concerning a 16 year old female with a history of seizures after unspecified vaccines (believed to be associated with pain of vaccination) who on 22-OCT-2007 was vaccinated intramuscularly with a 0.5 second dose of Gardasil. Concomitant vaccinations at the same visit included influenza virus vaccine (unspecified (unspecified) and Vaqta (MSD). On 22-OCT-2007 the patient had a small seizure. The patient was kept at the doctors office for 30 minutes. On 22-OCT-2007, the patient recovered and was sent home. Upon internal review, small seizure was considered to be an other important medical event. Additional information has been requested.									Y	10/22/2007	10/22/2007	0	None	OTH	OTH			Pain during injection; Convulsion; Immunisation		WAES0710USA04881	1						1	Convulsion	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~MERCK & CO. INC.~~UNK~UN~UN~HEP A (VAQTA)~1|HPV4~MERCK & CO. INC.~~2~IM~UN~HPV (GARDASIL)~1	USA		Influenza
0295005	10/31/2007	CA	60.0	60		F	10/26/2007	Initial report received from a health care professional on 17 October 2007. A 60-year-old female with a history of asthma and allergies to Biaxin and Keflex had received a left deltoid intramuscular injection of Fluzone (lot number U2463AA). On 16 October 2007 and immediately after vaccination, she experienced paresthesia in her left cheek and lip. The patient also experienced soreness at the injection site on the left deltoid on an unspecified date. The patient had received three previous doses of Fluzone. At the time of the report, the patient had not recovered. No additional information was provided. The reporter of this case is the same as for case 2007-03521, which involves a nodule at test site of left forearm following receipt of Tubersol, lot number C2461AA.				Y					N	10/16/2007	10/16/2007	0		UNK	UNK			The patient had a history of asthma. The patient had allergies to Biaxin and cephalosporin (Keflex); itching was reported. The patient had no illness at the time of vaccination and was not taking any other medications.		200703520	1						1	Injection site pain; Paraesthesia	FLU3~SANOFI PASTEUR~U2463AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295008	10/31/2007	MD	15.0	15		M	10/31/2007	rt leg pain, rt knee stiffnes and gait disturbance that waxes and wanes and then resolves.									Y	10/24/2007	10/25/2007	1		PVT	PVT	none	none	hx of similar reaction to flu vaccine 3y ago	joint/leg pain~Influenza (Seasonal) (Fluzone)~2~12.00~In Patient		1						1	Gait disturbance; Joint stiffness; Pain in extremity	FLU3~SANOFI PASTEUR~unknown~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295009	10/31/2007	OH	1.33	1	.3	M	10/31/2007	none									Y	10/30/2007				PUB	PUB		cold, no fever				1						1	No adverse reaction	DTAP~SANOFI PASTEUR~U1985CA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT2460AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF108AA~4~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~PB08692B~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0295010	10/31/2007	TX	53.0	53		F	10/31/2007	Day 1: feverish at injection site Day 2: soreness/knot at injection site Day 3: body aches, chills Day 4: fever, severe chills, nasal congestion Day 5: low grade fever, lethargic (report made on day 5)									U	10/26/2007	10/29/2007	3		PUB	UNK	cenestin .0625mg 1x daily; flexeril 1x daily(pm); cymbalta 90mg 1x daily(pm);	fibromyalgia; chronic fatigue syndrome; Vitamin B deficit/anemia	fibromyalgia; chronic fatigue syndrome; Vitamin B deficit/anemia; allergies to penicillin, grasses, trees, nuts, shellfish, dust mites; allergic rhinitis asthma			1						1	Chills; Injection site nodule; Injection site pain; Injection site warmth; Lethargy; Nasal congestion; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~unknown~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0295012	10/31/2007	NY	74.0	74		M	10/31/2007	no adverse event. Tdap vaccine given to an individual greater than 64 years of age.										10/22/2007			none	PUB	PUB		ambulates with difficulty, uses walker.	h/o prostate Ca with radiation treatment greater than one year previous.			1						1	Inappropriate schedule of drug administration; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA282DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|TDAP~SANOFI PASTEUR~C2730AA~1~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0295014	10/31/2007	OR	33.0	33		F	10/31/2007	Started to feel sick a few hours after the shot was administered.  Turned into fever, felt like my head was going to explode, face felt like it was on fire, but hands and feet where frozen, body aches, stiff neck, labored breathing, hands itching. No treatment sought, suffered through, felt better next day.									Y	10/30/2007	10/30/2007	0		PVT	PVT	Allegra	none	Hay Fever			1						1	Dyspnoea; Headache; Malaise; Musculoskeletal stiffness; Pain; Peripheral coldness; Pruritus; Pyrexia; Skin warm	FLU3~CSL LIMITED~AFLUA274BA~5~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0295016	10/31/2007	KY	68.0	68		F	10/31/2007	Received pneumococcal and flu injections ins (left) arm on 10/26/07, Friday.  Saturday morning - was sore, site was puffy, swollen red. Body was achy, chills/warm, fever? - temp not taken.  By Sunday was feeling better.  Reaction site measure on Monday at doctor's office as 16.5 cm across by 8 cm downward - about the size of a hand print. On 10/31/07 - Wednesday, having started Keflex treatment on Monday, everything is fine, site reduced to about 2 in circle of a sore, reddened lump.				Y					Y	10/26/2007	10/27/2007	1	none	UNK	UNK	for hypertension	none	HTN			1						1	Chills; Injection site erythema; Injection site swelling; Pain; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua283ea~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0990u~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0295017	10/31/2007	PA	16.0	16		F	10/31/2007	Pt received varicella vaccine from our office on 10/20/2007.  Pt diagnosed with chickenpox by Reading Hospital ER physician in October 2007.									Y	02/20/2007	10/25/2007	247		UNK	UNK	None known	No known	None	None~ ()~~0.00~In Patient		1						1	Varicella; Varicella post vaccine	FLU3~SANOFI PASTEUR~U2262AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2172AA~UNK~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~1310F~UNK~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0295018	10/31/2007	OH	0.5	0	.5	M	10/31/2007	Two days after receiving vaccinations patient began flapping his hands, a neurologically self- stimmulating behavior, and stopped babbling entirely.  Up until this point, patient was above-average language abilities.  He became listless, and also stopped napping.  Nine days after the immunizations he lost his ability to roll from front to back and back to front.  Patient had been able to roll since three months of age.  We sought medical evaluation from Dr. and received a diagnosis of encephalopathy.  At this point Dr. expressed concern about the possibility of regressive autism, but patient's social interaction was relatively good.  Patient underwent a cranial MRI, as well as extensive metabolic and genetic testing.  All were normal.  Patient did regain his ability to roll after over two months of immobility, but still suffers from marked developmental delays. 12/26/07-records received-office visit 2/26/07-seen for atypical development. Four days after immunizations obsrved rocking head side-to-side. Futher regression continued. 4/23/07 visit Receiving OT and PT and hypertonia has given way to hypotonia. Improving with therapy. Appears to have been a transient illness. 9/17/07- office visit-Demonstrating atypical signs in development. Consistent with autism. 11/12/07-receiving hyperbaric oxygen treatments. Finger nails bright pink. Per 60 day follow up: He has shown continued degredation of his nervous system including the loss of deep tendon reflexes in all extremities and the development of cortical thumbs. He was tested for metachromatic leudodystrophy (ruled out) and test results are pending for acrodynia (Hg poisoning). He has been accepted into palliative care at our local childern's hosptial. He has additional VAERS reports - ID# 295015, filed by myself, and VAERS ID 284671-1, filed by his peditrician.				Y				Y	N	12/15/2006	12/17/2006	2	cranial MRI, genome hybridization w/ micro array, urine and serum amino acids, urine organic acids 12/26/07-records received-EEG normal. MRI normal.	UNK	UNK			developmental delay	encephalopathy~Vaccine not specified (no brand name)~~0.30~In Patient		1						1	Abnormal behaviour; Amino acid level normal; Childhood disintegrative disorder; Developmental delay; Dyskinesia; Encephalopathy; Gene mutation identification test; Hypertonia; Listless; Nervous system disorder; Nuclear magnetic resonance imaging normal; Sleep disorder; Urine analysis normal	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B034AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2200PA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~UNKNOWN MANUFACTURER~UE792AA~3~IM~LA~HIB (NO BRAND NAME)~1|PNC~PFIZER\WYETH~B08649E~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Disabling	Influenza
0295020	10/31/2007	TN	23.0	23		F	10/31/2007	Received flu vaccine at 0200, 10/18/07. By 1530, 10/18/07, lips became tingly and numb. Top lip became swollen. Took a Benadryl and by 10/19/07, symptoms had subsided.									Y	10/18/2007	10/18/2007	0		PVT	PVT	None	None	None			1						1	Hypoaesthesia oral; Lip swelling; Paraesthesia oral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80686~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295028	10/31/2007	CA				M	10/31/2007	This case was reported by a physician and described the occurrence of cellulitic type skin reaction in an adult (50 plus years of age) male subject who was vaccinated with (Fluarix, GlaxoSmithKline) for prophylaxis. Concurrent vaccination included pneumococcal vaccine (manufacturer unspecified) given on 9 October 2007. Concurrent medications were not specified. On 9 October 2007 the subject received unspecified dose of Fluarix in an unknown arm. Within a few days of vaccination with Fluarix, the subject experienced a cellulitic type skin reaction, fever to 102 degrees and body pain. The subject received antibiotics in the emergency room and missed work due to the events. This case was assessed as medically serious by GSK. At the time of working the events were resolved.				Y					Y	10/09/2007			UNK	OTH	OTH	Unknown	Unknown	It was reported that the subject has a medical history of unspecified immune problems. The subject has previously received flu shots with no reactions documented.		A0690631A	1						1	Cellulitis; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA303AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0295032	10/31/2007	OR	0.5	0	.5	F	10/25/2007	The evening of imm's - irritability, crying, increasing to unconsolable screaming for over 12 hours starting the next morning, seizure like activity x 1 - shaking, eye rolling, drooling approximately 19 hours after imm's. No fever. Hospitalized x 2 days for w/u of seizures in infant. 11/7/07-records received for DOS 10/23-10/25/07- DC DX: Possible seizures, developmental delay, infection ruled out. Day prior to admission she was noted by PCP to be mildly developmentally delayed in her gross motor functions. Not sitting up, rolling front to back only. Later same day became irritable, fussy and next afternoon whole body shaking and her eyes rolled up. Parents are poor historians as they are both diagnosed with MR and are delayed.				Y	Y	2			Y	10/22/2007	10/23/2007	1	LP/ CSF NL; EEG NL; EKG NL; BCX/UCX/CSF CX NL; HEAD CT NL 11/7/07-records received-CSF culture negative, Protein and glucose normal. CBC-WBC 16.1, segs 47. CT head normal. EEG normal.	PVT	PUB			Mild gross motor delay; Colic 11/7/07-records received-HX of head shaking and body shaking when she was 1 month old.			1						1	Blood culture negative; CSF cell count normal; CSF culture negative; CSF test normal; Computerised tomogram normal; Convulsion; Crying; Culture urine negative; Drooling; Electrocardiogram normal; Electroencephalogram normal; Gaze palsy; Irritability; Screaming; Tremor	DTAP~SANOFI PASTEUR~U2156AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2459LA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0170~3~SC~RL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~B70143E~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0295033	10/31/2007	MD	38.0			F	10/26/2007	I was given the flu vaccine in my shoulder area. Ever since, I have this horrible pain down my arm to my elbow. The pain is now in my shoulder area, upper back, and outer shoulder. I can't raise my arm above my head - it hurts too much. It also hurts at night. In all the years I've received the flu vaccine. I have never had this kind of persistent pain in the shoulder area. Usually, it is in my arm muscle and last only a couple of days. I think the nurse did not administer it correctly. The shot was given in the upper shoulder area. I think it may be tendonitis. I'm not sure if it is an administration error or a bad lot of vaccine that I was give. I hope the pain goes away. It has been going on now for 2 weeks and has become worse. I can hear my shoulder joint pop as well when moving it. I didn't have any issues with this shoulder prior to the vaccine. Per 60 day follow up: Still have arm pain & muscle pain. Arm is painful & can't lift things over my head. This has been going on for 4 months now. Is this happening to others? The Dr. office should be made aware that this problem is still going on. When will it go away. 1/15/2010 Arm pain.									N		10/15/2007			UNK	UNK			No prior Medical conditions, NKA, No preg, smoking or other diseases.			1						1	Hypokinesia; Myalgia; Tendonitis	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0295037	10/31/2007	PA	23.0	22		M	10/31/2007	Patient complained of minor shortness of breath, no wheezing or tightness noted.  Patient states he felt like he had been running for a while after receiving influenza, live, intranasal vaccination.				Y					Y	10/31/2007	10/31/2007	0	None	MIL	MIL	None noted	No	None by record	None~ ()~NULL~~In Patient|none~ ()~NULL~~In Sibling1|none~ ()~NULL~~In Sibling2		1						1	Dyspnoea	FLUN3~MEDIMMUNE VACCINES, INC.~500484P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0295038	10/31/2007	FL	61.0	61		F	10/31/2007	Received shot at 3:10 PM on Monday Oct 29th woke up during the night with very bad headache, took Tyneol.  In the morning every muscle ached, felt week and short of breath.  Slept most of the day.Kept breaking out with sweats and then chills, no appitite no energy to get sometime to eat.  Felt so bad I wish I would die.  Today is day 2 and I am able to get up and move around some as soon as I move I break out in a sweat.  I am hoping that this is the end									U	10/29/2007	10/30/2007	1		UNK	PVT						1						1	Anorexia; Asthenia; Chills; Dyspnoea; Feeling abnormal; Headache; Hyperhidrosis; Myalgia	FLUX~UNKNOWN MANUFACTURER~U2492AH~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0295041	10/31/2007	MI	77.0	77		F	10/31/2007	After flu shot complained she felt funny, pain in both arms, BP 140/90, heart rate 88 irregular. Gave juice & nitro without relief. Ambulance to ER. spoke to her 7 hours later at home said didn't have a heart attack but needs stress test and already had appt with heart dr 11-1-07.				Y					Y	10/29/2007	10/29/2007	0		PUB	PVT			allergic to CT scan dye			1						1	Feeling abnormal; Pain in extremity	FLU3~SANOFI PASTEUR~U2505AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295042	10/31/2007	CO	63.0	63		F	10/31/2007	Pneumovax shot given 10-30-2007.  Woke 10-31-2007 to extreme pain in injected left arm- specifically in the shoulder and elbow joints. Said the pain was so intense that she could not move her arm.  Instructed pt. to take 50mg of diphenhydramine.  Followed up with patient about 2 hrs later, and the pain had somewhat subsided.  Was not seeking medical attention at that time.									Y	10/30/2007	10/31/2007	1		UNK	UNK	n/a	none				1						1	Arthralgia; Injected limb mobility decreased; Musculoskeletal pain; Pain	FLU3~SANOFI PASTEUR~u2488aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0038u~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295043	10/31/2007	NM	2.0	2	.5	M	10/31/2007	Child had flu shot @ about 10 am. Waited in office for 20 minutes. Went home w/mother and private duty nurse. Nurse reported he was fussy after the immunization. She held him until he went to sleep. They put child to bed in parental bedroom upstairs. Nurse went to kitchen to get g-tube feeds ready. Apnea alarm went off shortly thereafter. When RN got to the child, he was face down in the bed and blue. They administered CPR, called 911. He was airlifted to hospital, where he was pronounced dead approximately two hours after receiving the flu shot.  11/13/07 Received autopsy report which reveals COD as complications of cerebral dysgenesis of indeterminate etiology; arthrogryposis multiplex congenita was a significant contributing factor.  Had been placed on side for nap but was found prone.  Disabilities rendered unable to lift head/body to protect airway. 11/16/07 Received vax records from pcp.  VAERS database updated w/same.	Y	10/22/2007		Y					N	10/22/2007	10/22/2007	0		UNK	UNK	Albuterol (2.5mg/3ml-Bullets)   3 ml BID or TID & PRN; Robinul (0.2mg/ml)            2 ml TID Prevacid SoluTab (15mg/tab)   1 tab BID(am & hs) Glycolax 2 tsp QD Children's Tylenol 4ml Q4 hours PRN increased Temperature		This child was in a program. He had a multitude of diagnoses and problems including interrupted development of white matter of the brain, seizures, arthryogryposis of CNS origin, cyanotic spells, apneic events, problems with thermoregulation, reflux, aspiration. He had a pacemaker implanted about a year ago and had been doing much better since then. Parents report he has not have a respiratory or cardiac arrest since then. He did still have seizures monthly. He had posturing and tics on a daily basis. He had an uncoordinated swallow and was at high risk for aspiration. I am the child's nurse case manager and I have only been working with the family for about 4 months (the family was transferred to me due to internal staff reassign-ments).  I reported his death to the State as required. I don't know who administered the immunization. I don't know if nurse filed a VAERS. Dr. was not in the office due to his father being in intensive care. The family reports patient had flu shots in the past without difficulty. I spoke with Dr. because I felt a VAERS was warranted. She gave me information and the website info and I am submitting this form today. I will be out of my office for about 3 weeks starting Sunday, November 4. In my absence, you may speak with my program's director.  She is aware that I have filed this report.  PMH: early ROM w/decreased amniotic fluid & subsequent joint contractures.  Medically fragile w/multiple conditions including severe GERD. Multiple malformations of brain with developmental delay.  Recurrent episodes of apnea & structural compromise of airway.			1						1	Apnoea; Cyanosis; Death; Irritability	FLU3~SANOFI PASTEUR~UT2489MA~UNK~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0295044	10/31/2007	IA	77.0	77		M	10/16/2007	Seen in ER 10/3 with c/o confusion, increased temp, chills, nausea and vomiting and large ecchymosis around vaccination site. Pt has had flu vaccine in past with no adverse reaction. 12/10/07-records received for DOS 10/3-10/4/07-DC DX: post influenza vaccination fever. Delirium secondary to medication, antihistamine. Presented to ED with confusion and fever. Temp 39.4. Appeared flushed. Large ecchymosis around vaccination site. Episodes of vomiting, nausea, chills rigors. Removed clothing, fell. CXR:low lung volumes no acute findings.					Y	1			Y	10/02/2007	10/03/2007	1	CBC; BMP; Ferritin; CPK; UA; Urine C+S; Blood culture ; Vit B12; Folate 12/10/07-records received-CXR:low lung volumes no acute findings. CT head:no signs of acute intracranial abnormality.	PUB	OTH		None	Cognitive decline; PVD; CVD with S/P CVA; TIA's; Nephrolithiasis; Colitis; Osteoarthritis; GERD; Gastritis 12/10/07-records received-PMH: cognitive decline. peripheral vascular disease. Cerebrovascular disease with stroke with partial hemiparesis. Treansient ishcemic attacks. Nephrolithiasis. Colitis. Osteoarthritis. Ankylosing spondylitis. Right eye enucleation. Gastroesophageal reflux disease. Gastritis.			1						1	Blood creatine phosphokinase; Blood culture; Blood folate; Body temperature increased; Chills; Confusional state; Culture urine; Full blood count; Injection site haemorrhage; Metabolic function test; Nausea; Serum ferritin; Serum ferritin normal; Urine analysis; Vitamin B12; Vomiting	FLU3~SANOFI PASTEUR~62449AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0295045	10/31/2007	NJ	49.0	49		F	10/23/2007	Itchiness from head to toe, tightening of throat muscles. From 10/19/07 at 5 PM up to 10/22/07 every day. Benadryl 100mg, once a day x 4 days.			Y	Y					Y	10/19/2007	10/19/2007	0	Blood tests, EKG.	OTH	OTH	None	None	GERD			1						1	Blood test; Electrocardiogram; Pruritus generalised; Throat tightness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79489~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening	Influenza
0295046	10/31/2007	TX	53.0	53		F	10/19/2007	red, swell, increased urticaria and under arm warm to touch. (R) Deltoid area No adverse rxn reported from any previous vaccination.									Y	10/18/2007	10/18/2007	0	None	OTH	PVT	Synthroid 75mg 1 time a day, Singulair 10mg 1 time a day, Nexium 40 mg 2 time a day, Advair 250/50 mg 2 time a day, Fosamax 70mg 1 time a week, Duo Neb As Needed, Ogen 0.625mg 1 time a day, Provera 2.5 mg 1 time a day, Potassium 10 mg 1 tim		Epi Pen Allergic Emergencies, Prednisolone 15mg/5mL Allergic Emergencies, Zyrtec Syrup 1 mg/ml Allergic Emergencies, Zantac 150mg Allergic Emergencies, Penicillin, Pentohal, Iodine, Codeine, Crestor, Z-Pack			1						1	Erythema; No reaction on previous exposure to drug; Skin papilloma; Swelling; Urticaria	FLU3~SANOFI PASTEUR~U2514AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295051	10/31/2007	WI	65.0	65		F	10/24/2007	Within 4 hr of receiving pneumococcal/influenza vaccine, patient had hives on arms bilaterally. Itchy sensation behind ears. Noticed she had to use her O2 more frequently than usual usage.									Y	10/18/2007	10/18/2007	0		PUB	PVT	Unk	Emphysema	Emphysema			1						1	Condition aggravated; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2441AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~U858U~2~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295052	10/31/2007	GA	0.8	0	.8	F	10/25/2007	Receive influenza vaccine 10-22-07. Urticarial rash on both legs.									Y	10/22/2007	10/23/2007	1		PVT	UNK		None				1						1	Urticaria	FLU3~SANOFI PASTEUR~UT2459PA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295055	10/31/2007	CA	23.0	23		F	10/25/2007	Passed out about 1 minute after injection. Sent for ER only as a precaution. Per EMT, pt stable.				Y					Y	10/25/2007	10/25/2007	0		OTH	PVT		None				1						1	Loss of consciousness	FLU3~SANOFI PASTEUR~U2515AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295056	10/31/2007	MN	3.0	3		M	10/26/2007	Local redness 11 cm x 7 cm.				Y					Y	10/24/2007	10/26/2007	2	None	PVT	PVT	Zantac	Reflux	Peanut Allergy			1						1	Erythema	FLU3~SANOFI PASTEUR~U2478AA~4~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295057	10/31/2007	PA	31.0	31		F	10/24/2007	Erythema (L) arm, c/o pain (L) arm tender. *Indurated has gotten sick with vaccine before achey coughing c/o headaches. Total body pain.				Y					Y	10/22/2007	10/22/2007	0		PUB	PUB	Ibuprofen-200 mg	no illness	Amoxicillin, Codeine, PCN/Sulfa meds			1						1	Cough; Headache; Injection site erythema; Injection site induration; Injection site pain; Pain	FLU3~SANOFI PASTEUR~U2490AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295058	10/31/2007	OK	23.0	23		M	10/24/2007	c/o severe headache, abd pain, increased temperature 2 hours after vaccine T 99 deg administration				Y					Y	10/23/2007	10/23/2007	0	Treated in Claremore emergency room	OTH	OTH		Hx Cerebral palsy, Peg tube, Spasticity Neurogenic Bladder	Penicillin, Had rx to DPT but has had flu and Pneumonia shots			1						1	Abdominal pain; Body temperature increased; Headache	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80060~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0295059	10/31/2007	AZ	72.0	72		F	10/22/2007	Difficulty breathing, fatigue, weakness, lasting 6 days.				Y					Y	10/12/2007	10/13/2007	1	10/14/07 - Urgent Care - checked oxygen level blood sugar and hemoglobin count. All satisfactory.	OTH	OTH	Lithium; Paxil	None	None			1						1	Asthenia; Blood glucose normal; Dyspnoea; Fatigue; Haemoglobin normal; Oxygen saturation normal	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0295060	10/31/2007	RI	61.0	61		F	10/22/2007	3 small red spots near injection site										10/16/2007				PVT	UNK						1						1	Injection site erythema; Injection site papule	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA026AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~02004~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295062	10/31/2007	MD	58.0	58		M	10/24/2007	4 days after vaccine patient developed diffuse hives, swollen tongue and difficulty swallowing.				Y					U	10/11/2007	10/15/2007	4	None	PVT	PVT	Lotensin, Vytorin, Metanx, ASA, CoQ10, Vitamins	None	Type 2 DM, HTN, Dyslipidemia			1						1	Dysphagia; Swollen tongue; Urticaria	FLU3~SANOFI PASTEUR~U2439AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295063	10/31/2007	PA	8.0	8		M	10/24/2007	After was given Varivax and flu vaccine c/o throat being scratch and respiratory distress. Given Benadryl, epi pen jr, O2 by face mask and transported to hospital				Y					Y	10/24/2007	10/24/2007	0		PVT	PVT	Flovent, Albuterol	None	Milk allergy, Asthma, BM&T, adenoidectomy			1						1	Respiratory distress; Throat irritation	FLU3~SANOFI PASTEUR~U2490AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1352U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0295068	10/31/2007	NE	76.0	76		F	10/18/2007	76 y/o 7 days post Tetanus injection presents with R) upper arm red et painful. Started on Sunday 10/14/07. no fever 97.9 BP 104/60. Keflex x 500 mg bid x 10days.				Y					U	10/10/2007	10/14/2007	4	CBC Normal; Eosinophils slightly elevated	PUB	PUB		c/o fatigue buzz/ringing L) ear. c/o dizzy spells	PCN Allergy; Hypercholesteremia, Osteopenia			1						1	Eosinophil count increased; Full blood count normal; Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U2442AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U1950BA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0295069	10/31/2007	NM	44.0	44		F	10/24/2007	Pt seen on 10-19-2007 0930. Received flu in the late evening/night, noticed left arm (upper) swelling, redness, warm to touch, painful came to clinic on 10-22-2007. Seen by PAC. Recommends Tylenol/Motrin, ice pack, Benadryl				Y					Y	10/19/2007	10/19/2007	0		PUB	UNK						1						1	Erythema; Oedema peripheral; Pain; Skin warm	FLU3~SANOFI PASTEUR~U2454AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~09614~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0295070	10/31/2007	OR	58.0	58		M	10/24/2007	Pt. states (R) arm sore last night and noticed redness and swelling this morning.				Y					U	10/23/2007	10/23/2007	0		PVT	OTH	Multi-Vit. Lisinopril, HCTZ, ASA	cough-HTN	Allergic-Tetracycline			1						1	Erythema; Limb discomfort; Oedema peripheral	FLU3~SANOFI PASTEUR~U2454AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0961U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0295072	10/31/2007	CO	50.0	50		F	10/24/2007	First got hives (next day) that night leg and arm and hand cramps 3 and 4th days, extremes hand and joint cramps, swelling of extremities. Numbness in fingers and hands tingling in fingers still after 1 week.				Y					U	10/16/2007	10/17/2007	1		PUB	PVT						1						1	Hypoaesthesia; Muscle spasms; Oedema peripheral; Pain; Paraesthesia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0295073	10/31/2007	CA	65.0	65		F	10/19/2007	Gave 2 immunization over (L) Deltoid on 10/17 On 10/19/07- 5 x 4 area redness, swelling arm (L) biceps									N	10/17/2007	10/18/2007	1	None	PVT	PVT		Viral URI	No			1						1	Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~U2437AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0883F~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295075	10/31/2007	WV	74.0	74		F	10/24/2007	Hives, which started the evening after the Flu and Pneumonia was given. Worse next day. Itching almost unbearable. Started on Benadryl 2nd day and used Hydrocortisone cream 1%. They are better on 9th day, but still itch.									Y	10/16/2007	10/16/2007	0	Did not see a doctor	PVT	OTH		None	Pharyngitis caused by allergies Feb 07			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~42446AA~2~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~06015~1~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295077	10/31/2007	MA	1.74	1	.7	M	10/24/2007	Child was given flu mist at 10/20/07 clinic, not yet 2 yrs. old DPH recommends revaccinate in one month with Inactivated flu vaccines.										10/20/2007				PVT	UNK						1						1	Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~500486P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0295080	10/31/2007	MT	65.0	65		F	10/23/2007	Pt rec'd vaccine (Fluzone) on 10/15/07 at flu clinic at pharmacy. Pt called pharmacy on 10/20/07 complaining of soreness at and around injection site. Pt noted no swelling, redness. Pain worsened during night per pt report. Pt was called again on 10/24/07 to follow-up on symptoms. Pt continues to report and pain in upper arm and lower shoulder upon movement, but severity is lessening. At does not desire to seek medical attention at this time (10/24/07). Plan on calling patient again on 10/29/07 to follow-up.									Y	10/15/2007	10/20/2007	5		OTH	UNK		None	None			1						1	Injection site swelling	FLU3~SANOFI PASTEUR~U2488AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295081	10/31/2007	NY	8.0	8		F	10/24/2007	Pt awoke the next morning with a rash on her cheeks - hive like rash.									U	10/23/2007	10/24/2007	1		PVT	PUB		None	None			1						1	Rash; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500488P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0295083	10/31/2007	WI	62.0	62		M	10/26/2007	Fever to 101. Local pain, erythema at site of injection.										10/24/2007	10/25/2007	1	See in office 10/26/07	PVT	PVT	Aspirin; Atenolol; Plavix; Simvastatin; Claritin; Prilosec		CAD, Hypercholesterolemia, Tobacco Dependence			1						1	Injection site erythema; Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~U2499aA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0200U~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295086	10/31/2007	PA	53.0	53		F	10/25/2007	Pt received a flu shot - Fluzone - 10/22/07 at 1100. She states later the same day, it became swollen, painful, not itchy. When I saw (L) deltoid site on 10/24, it was mildly red 9cm x 7cm area, faintly raised, no undue warmth of area, tender or palpation.									Y	10/22/2007	10/22/2007	0	None	OTH	PVT	med for HTN	None	HTN			1						1	Erythema; Pain; Swelling	FLU3~SANOFI PASTEUR~U2497AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295088	10/31/2007	MI				F		Dermatitis face, onset few hours after receiving FluMist.				Y					Y	10/20/2007	10/21/2007	1		MIL	MIL	N/A					1						1	Dermatitis	FLUN3~MEDIMMUNE VACCINES, INC.~500484P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0295089	10/31/2007	CT	32.0	32		F	10/25/2007	Patient stated having nausea, vomiting, difficulty breathing, chest pain, lethargy. Pt was given epinephrine shot 0.3 ml SC and sent to ER via ambulance. Pt now Ok. ER nurse stated patient is ok. To be seen by MD and d/c'ed home.				Y					Y	10/25/2007	10/25/2007	0	None	OTH	OTH	Epinephrine shot 0.3 ml SC	None	None			1						1	Chest pain; Dyspnoea; Lethargy; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U2490AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295092	10/31/2007	CT	62.0	62		M	10/26/2007	Severe chills from nose to the toes. Both feet suffered terribly started at approximately mid nite, ceased approximately 8:30 a.m. Have never ever, been this cold 5 blankets, insulated under garments heating pad did not help. Slight stomach sickness, no fever.									Y	10/15/2007	10/16/2007	1		MIL	MIL	METOPROLOL; FOSINOPRIL		Angina - bypass heart surgery			1						1	Chills; Stomach discomfort	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80061~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295093	10/31/2007	NY	2.0	2	.5	F	10/23/2007	-urticarial rash from head to toe approx 24 hrs after getting immunization -responded to Benadryl				Y					Y	10/01/2007	10/02/2007	1		PVT	PVT	None	None	None			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2466AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295094	10/31/2007	MN	40.0	40		F	10/25/2007	Hives on arm and on neck. Took Benadryl.									Y	10/12/2007	10/12/2007	0	None	PVT	PVT	N/A	Cough	Allergies to some meds	Swelling/hot~Hep B (no brand name)~3~36.00~In Patient		1						1	Urticaria	FLU3~SANOFI PASTEUR~U2466AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295095	10/31/2007	WA	45.0	45		M	10/23/2007	Temp of 103, vomiting, pain at injection site (L) arm, swelling at injection site in (L) arm.				Y					Y	10/18/2007	10/19/2007	1		PVT	UNK		None	Hx of pneumonia, HTN, Hypercholesteremia	Similar~Influenza (Seasonal) (no brand name)~1~0.00~In Patient		1						1	Body temperature increased; Injection site pain; Injection site swelling; Vomiting	FLU3~SANOFI PASTEUR~U444AA~4~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0961U~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0295096	10/31/2007	FL	8.0	8		M	10/25/2007	Patient is autistic. He was stable in behavior. He was given the Flu shot and became violent and defiant in behavior for 12 days. He was totally out of control in all surroundings (Home, School and Aftercare). Loss of appetite and sleep patterns also changed.									Y	10/12/2007	10/14/2007	2		PUB	UNK	ZYREXA; DEPAKOTE; ZONEGRAN; SEROQUEL; STRATTERA		Autism; Epilepsy; ADHD, ODD			1						1	Aggression; Anorexia; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0295097	10/31/2007	IN	3.0	3		M	10/26/2007	Leg swollen very much, red, and warm to the touch, knee fluctuant, thigh twice the size as right.				Y					Y	10/24/2007	10/25/2007	1		PVT	UNK	Clarinex	None				1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2510AA~5~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295098	10/31/2007	CA	1.7	1	.7	M	10/25/2007	mother reports tonic-clonic seizure x 2 per about a minute each and separated only by a few seconds. Childs had 103.3 at that time. Child recovered quickly and has been fine since then.									Y	10/17/2007	10/19/2007	2	None	PVT	PVT		Mild cough				1						1	Body temperature increased; Grand mal convulsion	FLU3~SANOFI PASTEUR~UT2456CA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295101	10/31/2007	MO	3.0	3		F	10/25/2007	Father brought child back to office 2 days later. (L) upper arm red with purplish middle. Stated it look better than day before.									U	10/14/2007	10/15/2007	1	None	PVT	PVT			Hx asthma - wheezed night of vaccine			1						1	Erythema	FLU3~SANOFI PASTEUR~U2452AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295102	10/31/2007	AZ	85.0	85		M	10/25/2007	Cherry color pin point papules. V.S. O 4 x 24 O2 sats.									Y	10/22/2007	10/23/2007	1		OTH	UNK						1						1	Erythema; Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295103	10/31/2007	AZ	91.0	91		M	10/25/2007	cherry color pin point papules v.s every 4 hrs x 24 O2 sats									Y	10/22/2007	10/23/2007	1		OTH	UNK						1						1	Erythema; Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295104	10/31/2007	AZ	68.0	68		M	10/25/2007	Cherry color pin point papules. VS Q4 x 24, O2 sats.									Y	10/22/2007	10/23/2007	1		OTH	UNK						1						1	Erythema; Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295105	10/31/2007	AZ	81.0	81		F	10/25/2007	Cherry color pin point papules, VS Q 4 x 24, O2 sats.									Y	10/22/2007	10/23/2007	1		OTH	UNK						1						1	Erythema; Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295106	10/31/2007	AZ	70.0	70		M	10/25/2007	Cherry color pin point papules. VS Q 4 x 24, O2 sats.									Y	10/22/2007	10/22/2007	0		OTH	UNK						1						1	Erythema; Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295107	10/31/2007	AZ	69.0	69		F	10/25/2007	Cherry color pin point papules. VS Q 4 x 24, O2 sats.									Y	10/22/2007	10/23/2007	1		OTH	UNK						1						1	Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295108	10/31/2007	AZ	81.0	81		F	10/25/2007	cherry color pin point papules v.s. one time x 24 hr O2 sats									Y	10/22/2007	10/22/2007	0		OTH	UNK						1						1	Erythema; Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295109	10/31/2007	AZ	81.0	81		M	10/25/2007	cherry color pin point papules v.s. every 4 hr x 24 hr O2 sats									Y	10/22/2007	10/23/2007	1		OTH	UNK						1						1	Erythema; Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295110	10/31/2007	AZ	80.0	80		M	10/25/2007	Cherry color pin point papules. VS Q 4 x 24, O2 sats.									Y	10/22/2007	10/23/2007	1		OTH	UNK						1						1	Erythema; Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295111	10/31/2007	AZ	75.0	75		F	10/25/2007	cherry color pin point papules v.s. one time x 24 hr O2 sat									Y	10/22/2007	10/23/2007	1		OTH	UNK						1						1	Erythema; Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295112	10/31/2007	AZ	83.0	83		M	10/25/2007	cherry color pin point papule v.s. every 4 hr x 24 hr O2 sats									Y	10/22/2007	10/23/2007	1		OTH	UNK						1						1	Erythema; Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295113	10/31/2007	AZ	86.0	86		M	10/25/2007	cherry color pin point papules v.s. every 4 hrs x 24 hrs O2 sats									Y	10/22/2007	10/22/2007	0		OTH	UNK						1						1	Erythema; Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295114	10/31/2007	AZ	95.0	95		F	10/25/2007	Cherry color pin point papules. VS Q4 x 24, O2 sats.									Y	10/22/2007	10/23/2007	1		OTH	UNK						1						1	Erythema; Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295115	10/31/2007	AZ	98.0	98		F	10/25/2007	cherry color pin point papules v.s. every 4 hrs x 24 hrs O2 sats									Y	10/22/2007	10/23/2007	1		OTH	UNK						1						1	Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295116	10/31/2007	AZ	75.0	75		F	10/25/2007	Cherry color pin point papules. VS Q4 x 24, O2 sats.									Y	10/22/2007	10/23/2007	1		OTH	UNK						1						1	Erythema; Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295117	10/31/2007	AZ	84.0	84		F	10/25/2007	cherry color pin point papules v.s. every 4 hrs x 24 hrs O2 sat									Y	10/22/2007	10/23/2007	1		OTH	UNK						1						1	Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295118	10/31/2007	AZ	91.0	91		F	10/25/2007	cherry color pin point papules v.s. every 4 hrs x 24 hrs O2 sats									Y	10/22/2007	10/23/2007	1		OTH	UNK						1						1	Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295119	10/31/2007	AZ	84.0	84		M	10/25/2007	Cherry color pin point papules. VS Q4 x 24, O2 sats.									Y	10/22/2007	10/23/2007	1		OTH	UNK						1						1	Erythema; Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295120	10/31/2007	AZ	76.0	76		M	10/25/2007	Cherry color pin point papules. VS Q4 x 24, O2 sats.										10/22/2007	10/23/2007	1		OTH	UNK						1						1	Erythema; Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295121	10/31/2007	AZ	72.0	72		F	10/25/2007	cherry color pin point papules vs every 4 hr x 24 O2 sats									Y	10/22/2007	10/23/2007	1		OTH	UNK						1						1	Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295122	10/31/2007	TX	9.0	9		M	10/26/2007	child developed hives and facial swelling w/in 5 minutes after receiving Fluzone and Varivax vaccines. Subsequently, developed wheezing and decreasing blood pressure. Rx'd with SC Epinephrine x 3 doses, took Benadryl and steroids				Y					Y	10/23/2007	10/23/2007	0	Blood pressure monitoring	PVT	PVT	No	No	None			1						1	Blood pressure; Blood pressure decreased; Swelling face; Urticaria; Wheezing; Blood pressure increased; Breath sounds; Dyspnoea; Eye swelling; Flushing; Swelling face; Wheezing	FLU3~SANOFI PASTEUR~U2528AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1330U~2~SC~LA~VARICELLA (VARIVAX)~1|FLU3~SANOFI PASTEUR~U2528AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|VARCEL~MERCK & CO. INC.~1330U~UNK~SC~LA~VARICELLA (VARIVAX)~2	USA	Emergency room visit	Influenza
0295123	10/31/2007	CT	2.0	2	.8	M	10/30/2007	Developed sudden onset rapid eye blinking within 24 hrs of flu shot. Had previous episode 8/06 (not related to flu shot @ that time). Pt. still continues to have eye-blinking 6 days later. Being followed by neurologist, bld. wk and MRI pending.									N	10/24/2007	10/25/2007	1	Also, lyme titer, throat c/s Brain MRI-pending	PVT	PVT	c/s Emergency	None	Adenoidectomy and myringotromy (9/07); Dev. delay, speech delay		CT200719	1						1	Culture throat; Excessive eye blinking; Nuclear magnetic resonance imaging brain	FLU3~SANOFI PASTEUR~UT24562A~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295125	10/31/2007	MD	55.0	55		F	10/25/2007	c/o reddened arm swelling to (R) arm swelling to neck. No fever pain to (R) arm after injection swelling and neck im the am.										10/24/2007	10/25/2007	1		PUB	UNK		No	No			1						1	Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~U2523AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295126	10/31/2007	NY	51.0	51		F	10/30/2007	Pt states approximately 8 hours after vaccine noted sudden onset shortness of breath at rest. Sx lasted 2 hours and resolved. Also - bright red, blood shot sclera that persists after 16 hours.									Y	10/29/2007	10/29/2007	0		PVT	PVT	Lisinopril, Albuterol prn, Singulair	None - healthy	Asthma, hypertension, allergic rhinitis			1						1	Dyspnoea; Scleral discolouration	FLU3~SANOFI PASTEUR~U2500AA~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295130	10/31/2007	CA	43.0	43		F	10/31/2007	After flu shot the next day pt c/o nausea, hives,itching all over, Fever/chills. As of 10/31/07 c/o cough, body aches, hoarseness. Hives, itching resolved.				Y					U	10/23/2007	10/24/2007	1	Orthostats, CMP, lipid panel, CBC, Sed rate, TSH, T3, T4	PVT	PVT	Ritalin, Vicodin, Soma, Lorazepam, Effexor	None	Allergies, PCN, amoxicillin, erythromycin, HX toxic shock syndrome.			1						1	Blood pressure orthostatic; Blood thyroid stimulating hormone; Chills; Cough; Full blood count; Laboratory test; Nausea; Pain; Pruritus generalised; Pyrexia; Thyroxine; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA052AA~1~~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|TD~SANOFI PASTEUR~U1923GA~UNK~~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0295132	10/31/2007	TX	48.0	48		F	10/31/2007	Swelling of arm (right) + redness. Pt unable to lift. Advil, Benadryl, Dr. gave 2 Rx's Darvocet and Bactrim D.S.				Y					U	10/30/2007	10/30/2007	0		OTH	OTH						1						1	Erythema; Injected limb mobility decreased; Oedema peripheral; Injected limb mobility decreased; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2499AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0803U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~0803U~1~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0295134	10/31/2007	ID	70.0	70		F		Local redness, swelling, and tenderness to R deltoid after injection on 10/29/07. Has become less red and painful since then.				Y						10/29/2007	10/30/2007	1	None	PVT	PVT	Lipitor, Fosamax Plus D, Hydrocortisone cream					1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78489~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1381U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0295135	10/31/2007	KY	26.0	26		M	10/31/2007	3 1/2 hr after having flu shot reaction with c/o chest pain									Y	10/31/2007	10/31/2007	0	EKG	OTH	OTH	none	none	none; Allergic - Ceclor			1						1	Chest pain; Electrocardiogram	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80435~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295136	10/31/2007	NC	15.0	15		F	10/31/2007	Redness and itching at injection site L arm (no SOB or hives)									U	10/31/2007	10/31/2007	0		PVT	PVT			Mild egg allergy, Ceclor allergy			1						1	Injection site erythema; Injection site pruritus	FLU3~SANOFI PASTEUR~U2478DA~7+~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0389U~2~~RA~HPV (GARDASIL)~1	USA		Influenza
0295137	10/31/2007	TX	54.0	54		F	10/31/2007	10/30/07 8:30 pm Fluzone 0.5ml/IM administered. 10/31/07 0130 - Progressive headache, sniffles, sore throat and burning of eyes. Sclera and conjunctiva very red, moist with mild eyelid edema observed at 0645 am. Denies SOB or rash.										10/30/2007	10/31/2007	1		OTH	PVT	None	None	None			1						1	Eye irritation; Eyelid oedema; Headache; Ocular hyperaemia; Pharyngolaryngeal pain; Rhinorrhoea	FLU3~SANOFI PASTEUR~U2514AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295138	10/31/2007	IN	26.0	26		M	10/31/2007	Body aches, chills, sore throat									U	10/15/2007	10/20/2007	5	NONE	PUB	PUB	Metoprolol, Zoloft, Ibuprofen, Vicodin	NONE	HTN, Dylipidemia, Smoker, Obesity			1						1	Chills; Pain; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U2463AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295141	10/31/2007	AK	67.0	67		F	10/31/2007	Severe arthus reaction with rash				Y					Y	10/18/2007	10/19/2007	1		OTH	OTH	Leaxpro; Zocor; ASA 325mg; HCTZ 25mg; KLOR-CON; Nexium; Pavix; Flonase PRN	Bronchitis; SOM	CAD; HTN; S/P MI			1						1	Rash; Type III immune complex mediated reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA034AA~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0880F~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0295142	10/31/2007	NM	30.0	30		F	10/23/2007	School nurse called on patient's behalf to notify us that patient ended up with a 2 inch circular area around injection site. Followed up with physician and treated for cellulitis.				Y					Y	10/19/2007	10/20/2007	1		OTH	PVT	Singulair, Advair					1						1	Cellulitis; Injection site reaction	FLU3~SANOFI PASTEUR~U2488AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0961U~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0295143	10/31/2007	NM	58.0	58		F	10/23/2007	School nurse called on patients behalf to report patient had a 4x4 area on the bicep of the arm they had received the vaccine (in the deltoid) - red area - warm to touch MD advised probable allergic reaction and not to take flu shot again. Resolving on its own.				Y					Y	10/19/2007	10/20/2007	1		OTH	PVT						1						1	Hypersensitivity; Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U2488AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0961U~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0295144	10/31/2007	KY	1.55	1	.6	M		Pt was given 0.5 ml of influenza vaccine instead of 0.25 ml. Called CDC was told dose counts and possible positive local reaction. 10-31-07 no reaction per parents.										10/29/2007				PUB	PUB		None				1						1	Incorrect dose administered; No adverse reaction	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B049AA~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2502AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHABV149AA~2~IM~RL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~B08700H~4~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0295145	10/31/2007	CA	55.0	55		F	10/29/2007	Pt went to ER 10-27-07 c/o left arm redness; ER doctor states;pt has some erythema surrounding this with a sharply demarcated border consistent with mild cellulitis approximately 10 cm in diameter, no significant lymphadenopathy in area but dose have an indurated area in left axilla.				Y					Y	10/24/2007	10/27/2007	3	Doppler ultrasound of upper extremity: negative; Docs show fluid collection in left axilla; no abscess	PVT	PUB	Vicodin, Flexiril, HCTZ, Coumadin, Chantix, Naproxen, Clumgain, Albuterol		Emphysema, DA, Fibromyalgia, Hypercoagulate			1						1	Cellulitis; Erythema; Fluid retention; Induration; Ultrasound Doppler normal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79721~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0993U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0295146	10/31/2007	WA	80.0	80		F	10/30/2007	10-29-07 when she went to bed felt uncomfortable when she layed on her left side. After her bath this morning at 0700 noticed red puffy area below bandaid where received injections. 10/31/07 1150 70mm x 5511 erythema warm to the touch. 10/31/07 0900 totally resolved. No further issues.									Y	10/29/2007	10/30/2007	1	None	PVT	PVT	Mevacor, Multivitamin, Lisinopril, Tylenol Prn, Ocuvite	None	High Cholesterol, Hypertension, Abd Aneurysms			1						1	Discomfort; Injection site erythema; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA300B~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0294233	11/01/2007	NY	38.0	38		F	10/30/2007	Received flu shot on 10/02/07 four hours later became ill very bad pressure headache dizziness vomiting. Three days later was admitted to hospital with temporary vision loss in one eye and other symptoms above. Hospitalized for 10 days. I have viral meningitis as of Oct 29, 07 still have pressure headache that has never gone. I have some hearing loss in one ear.					Y	10			N	10/02/2007	10/02/2007	0	Was admitted to hospital from Oct 5, 2007 to Oct 15, 2007. All tests done there are in my medical records.	UNK	UNK	I had a flu shot and was hospitalized three days later. See above					1						2	Headache; Meningitis viral; Migraine; Nausea; Tenderness; Vertigo; Blindness transient; Deafness unilateral; Dizziness; Headache; Malaise; Meningitis viral; Vomiting; Dizziness; Ear discomfort; Headache; Intracranial pressure increased; Meningitis aseptic; Tinnitus; Vertigo; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78990~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78990~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~2|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78990~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~3	USA	Hospitalisation	Influenza
0295182	11/01/2007	SC	55.0	55		F	11/01/2007	Vaccinated with influenza and PPV23 on 10/12/07.  Fever on 10/12 through 10/17.  On Sunday, 10/14/07 experienced fever of 102.8 degrees. By 10/14/07, reddened area at injection site - approx 2 cms progressing to reddened oval area from site to elbow of right arm (PPV23 administered in right arm subcutaneously).  Passed outfor a few minutes early Sunday, 10/14/07.  Presented on Sunday.  No meds given.				Y					Y	10/12/2007	10/12/2007	0	EKG, UA, Blood Count - CBS.  All tests negative.	UNK	UNK	NONE	NONE	History of pneumonia and bronchitis		SC0718	1						1	Blood count normal; Electrocardiogram normal; Injection site erythema; Loss of consciousness; Pyrexia; Urine analysis normal	FLU3~SANOFI PASTEUR~U2448AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~05540~4~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0295183	11/01/2007	MI	53.0	53		F	11/01/2007	Patient received flu & pneumo vaccine on 10-30-07. Came to office on 10-31-07 with generalized pain whole body and fatigue which started 10-30-07 in the afternoon after getting flu/pneumo. Slight headache. Started in arms, now whole body. Positive rib pain with movement. No fever or nausea. Has had flu shot previously with no problems.									Y	10/30/2007	10/30/2007	0	Patient received Solu-Medrol 125mg at appointment on 10-31-07. Lab work was done.  WBC: 11.9, Sed rate: 34, hsCRP: 2.595 all other lab work was normal	UNK	UNK	Toprol XL 50mg 1/4 tab bid, Detrol LA 4mg 1 qd, Aldactone 25mg prn, Flexeril 10mg prn, ASA 81mg 1 qd, Lexaprol 20mg 1 qd, Anusol HC supp 25mg bid prn, Coumadin qd, Rythmol 150mg 1 tid, Fosomax 35mg 1 q week, Chantix, Calcium 600mg, Vitamin	No illness	A Fib/A flutter, osteoarthritis C-spine, urge incontinance, fibromyalgia, RSD, hyperlipidemia, diverticulosis, corneal dystrophy, anxiety, tobacco abuse, RLS, osteopenia, neurological sx possible microemboli related			1						1	C-reactive protein normal; Corneal dystrophy; Fatigue; Headache; Musculoskeletal chest pain; Pain; Red blood cell sedimentation rate increased; White blood cell count increased	FLU3~SANOFI PASTEUR~U2516AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0991U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295184	11/01/2007	IL	62.0	62		F	11/01/2007	10/29/07-woke up at night (does not know time) left bicep hurt. Left Bicep became red & hot. 10/30/07- Left Bicep became swollen.										10/29/2007	10/29/2007	0		PUB	PVT	Unable to inquire. She stated she had to attend to a student and needed to go.	States she was not ill at time of injection.	Dust animal pollen mold allergies. Receives weekly allery injection. Received last allergy injection on Monday 10/29/07. Unable to inquire site of allergy injections. She stated she had to attend to a student and needed to go.			1						1	Erythema; Pain in extremity; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79720~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0964U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295185	11/01/2007	VA	1.0	0	.0	M	11/01/2007	developed varicella disease (fever, vesicles) 11 days after administration of the disease									U	10/19/2007	10/29/2007	10		PVT	PVT	none	none	none			1						1	Blister; Pyrexia; Varicella; Varicella post vaccine	FLU3~SANOFI PASTEUR~ut2459ka~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0746u~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1012u~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0295187	11/01/2007	CO	64.0	64		M	11/01/2007	Pt. complained of pain in arm				Y					Y	10/26/2007	10/26/2007	0		UNK	UNK						1						1	Pain in extremity	FLU3~SANOFI PASTEUR~u2488aa~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295188	11/01/2007	CA	52.0	52		F	11/01/2007	Within 18 hours of vaccination I developed high fever (103F), shaking chills, arthralgia, head and neck pain, muscle pain, fatigue.  Symptoms lasted 2 days.									Y	10/26/2007	10/27/2007	1		PUB	PVT	None	None	None			1						1	Arthralgia; Chills; Fatigue; Headache; Myalgia; Neck pain; Pyrexia; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA307BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0295190	11/01/2007	MD	1.0	1	.0	M	11/01/2007	My son received the varicella vaccine on 10/17/07 and began to break out with bump/blisters on 10/25/07.  I had to take him to the ER with a fever of 104.3 on 10/27/07 since that day I could not get it to go down below 103.0 with meds.  I also noticed on that day that i had a few bumps breaking out I went to my physician on 10/29/07 with bumps/blisters, who stated that this could be or is chicken pox.  She said she was unsure what to do since I did have the disease as a child.  I have checked around and the vaccine that my son received was dead and therefore he should not of been able to transmit that disease to anyone else.  They are stating that this is a adverse secondary infection and I was thinking that it would be a good idea to report this to the CDC since this should not be something that happens after a child receives a dead vaccine.  The vaccine was given to my son as part of his 12 month vaccination.  He also received that day a few other vaccines that I have also given you the manufacturer and lot number for.  Also he had a very large red raised area around the injection site that is still is their on 11-1-07 but it looks as if it is finally starting to fade the size of the redened area would be about the size of a nickel.  I have also called and asked that his physican note this reaction in his chart.				Y					Y	10/17/2007	10/25/2007	8	no testing was done one patient but my physican had drawen blood from me to check the titer and that was all she could do to try and figure out why this out break was happening to me	UNK	UNK	patient that received the actual vaccine and I was told that I sould give him tylenol and or ibeprofen which would be approiate for his weight of 23 lbs	none	none			1						1	Blister; Blood test; Injection site erythema; Injection site swelling; Pyrexia; Secondary transmission; Skin lesion; Varicella	FLU3~SANOFI PASTEUR~UT2459NA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~04134~2~IM~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~12734~1~IM~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0295193	11/01/2007	OR	7.0	7		F	11/01/2007	Mother reports extreme left arm discomfort from time of injection for 3 days.   Day after injection had temp of 101.2 for 4 hours.   2 days after injection arm bright red, hot area 3 x 3;  lasted 48 hours.									Y	10/24/2007	10/26/2007	2	none	UNK	UNK		None known.	Frequent history of pheumonia and respiratory problems.			1						1	Body temperature increased; Erythema; Limb discomfort; Skin warm	FLU3~SANOFI PASTEUR~U2476JA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~O554U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295194	11/01/2007	MS	31.0	31		F	10/31/2007	reorted on 10/29 that she received a flu shot 10/22 @ employee flu clinic. Had soreness and swelling that afternoon. Next day shes said she had swelling @ site; on 10/24 noticed swelling in L neck area. Had some soreness in that area, but not a present. Still has minior swelling in that area. To make appointment with PMD. No fever after flu shot or at present.									U	10/22/2007	10/24/2007	2		UNK	UNK		None reoprted			MS07029	1						1	Injection site swelling; Local swelling; Pain in extremity; Swelling	FLU3~SANOFI PASTEUR~U2523AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295195	11/01/2007	MI	1.25	1	.2	F	11/01/2007	Client passed away today.  Cause of death unknown at this time.  An autopsy is to be performed down state.  8/18/09 Autopsy report 11/02/06. Additional information abstracted: Medical complications of omphalocele. History of repair of congenital omphalocele. Severe abdominal adhesions with extensive dilation of loops of small and large intestine. Status post gastrostomy tube placement. Acute proximal and distal convoluted tubular necrosis of kidneys. Extensive intersitial calcification of kidneys.	Y	11/01/2007							N	10/31/2007	11/01/2007	1		UNK	UNK			Fetal Omphalocele			1						1	Death	FLU3~SANOFI PASTEUR~ut2459lb~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0295199	11/01/2007	WA	23.0	23		M	11/01/2007	pain in arm, swelling/itching of R upper arm. cold pack/motrin									U	10/30/2007	10/30/2007	0	observation	MIL	MIL						1						1	Oedema peripheral; Pain in extremity; Pruritus	ANTH~EMERGENT BIOSOLUTIONS~FAV111~4~SC~RA~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500496P~6~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0295200	11/01/2007	MD	26.0	26		M	11/01/2007	vaccination given at 1 pm. Pt began with lightheadedness at 9:30pm. Then patient developed shaking and chills. Skin hot to touch. headache onset 12 midnight. Complaints of  feeling lost									Y	10/29/2007	10/29/2007	0		PUB	PVT	none	none	none			1						1	Chills; Dizziness; Feeling abnormal; Headache; Skin warm; Tremor	FLU3~SANOFI PASTEUR~U2488AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295202	11/01/2007	MI	12.0	12		M	11/01/2007	Approximately 18 hours after vaccination, pt experienced T of 102 and approximately 2 cm vesicular rash at site of injection.Pt. also complained of headache.				Y					U	10/29/2007	10/30/2007	1		PVT	PVT	None	Pharyngitis	Obesity; Snapping hip syndrome	None~ ()~NULL~~In Patient|None~ ()~NULL~~In Sibling1		1						1	Body temperature increased; Headache; Injection site rash; Injection site vesicles	FLU3~SANOFI PASTEUR~U2505AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2538AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~1343U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0295203	11/01/2007	NY	69.0	69		F	11/01/2007	Pt received vaccines for planned trip. After unknown time interval, was fatigued and tired. Progressed to left sided weakness and numbness. Seen in ER and found to have brain tumor via brain MRI. Serum will be sent to CDC for yellow fever testing.  11/2/07 Received vax records.  Yellow fever UE818AA; Hep A/B AHAVB195AB; Typhoid A0394; Polio A0170; Flu 79719.  VAERS database will be updated w/same. Record faxed to CDC.  11/6/07 Reviewed pcp medical records which reveal patient experienced HA x a few days starting w/bright light in left eye & HTN.  at office visit of 10/15/07, no evidence HTN & exam WNL.  10/16 t/c to office after speaking w/travel clinic stated she was not supposed to get YF or polio vaccine due to hx of Sjogren syndrome.  Labs done on 10/16 WNL.  Seen in office 10/22 due to persistent HA.  Returned to travel clinic & referred for MRI of brain which revealed glioma of basal ganglion.  Referred to neurosurgeon. 11/13/07 Reviewed hospital ER medical records which reveal paient seen 10/24/2007 after being sent by travelers clinic for 13 days of vague neuro symptoms including left sided HA, feeling confusion & dopey, inability to perform normal activities, left side paresthesias, blurred vision, anorexia, N/V intermittently & fatigue.  Neuro consult obtained in ER. FINAL DX: Primary brain glioma.			Y	Y					N	09/25/2007	10/15/2007	20	MRI brain LABS: MRIrevealed deep seated mass arising from right thalamus w/ mild mass effect & minimal surrounding vasogenic edema. CXR cardiomegaly w/atherosclerotic heart disease & mild bronchitis.	UNK	UNK	Plaquenil for last few years		Sjogren's syndrome PMH: Ophthalmic migraines; fatigue; IBS; allergic rhinitis; hyperlipidemia; spastic dysphonia; SLE; Sjogren syndrome; osteopenia; fibrocystic breasts; duodenal ulcer; basal cell cancer;COPD by CT of chest, 8/2000; URI 6/07 w/temporary hearing loss; back pain relieved w/PT; occasional heart palpitations.			1						1	Asthenia; Brain neoplasm; Fatigue; Hypoaesthesia; Nuclear magnetic resonance imaging brain abnormal	FLUX~UNKNOWN MANUFACTURER~79719~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHAVB195AB~UNK~~RA~HEP A + HEP B (TWINRIX)~1|IPV~SANOFI PASTEUR~A0170~UNK~~LA~POLIO VIRUS, INACT. (IPOL)~1|TYP~SANOFI PASTEUR~A0394~UNK~~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|YF~SANOFI PASTEUR~UE818AA~1~~RA~YELLOW FEVER (YF-VAX)~1	USA	Life Threatening	Influenza
0295204	11/01/2007	IA	74.0	74		F	11/01/2007	Patient had total body hives following influenza vaccine administration.									Y	10/23/2007	10/24/2007	1		UNK	UNK		None				1						1	Urticaria	FLU3~SANOFI PASTEUR~U2499AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295205	11/01/2007	VA	60.0	60		F	11/01/2007	Red, swollen, hot to the touch.  Reaction began 24 hrs after injection.  Swollen hard area remains to 10/31/07.									Y	10/19/2007	10/20/2007	1	none	PUB	PUB		no	diabetes		VA07:020	1						1	Erythema; Skin warm; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFluA2820DA~7+~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1132U~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295206	11/01/2007	IL	20.0	20		F	11/01/2007	RASH, TACHYCARDIA, HYPERTENSION, DIAPHORETIC Per follow-up: Sumitted a report earlier today and I did not notice place to but the treatment that was administered after the reaction. I was treated with an epi-pen Jr, 5o mg of BENADRYL and O2.									Y	10/25/2007	10/25/2007	0		UNK	UNK	ELMIRON, AMITRIPTYLINE, LEXAPRO		INTERSISTIAL CYSTITIS, FUNCTIONAL HEART MURMUR			1						1	Hyperhidrosis; Hypertension; Rash; Tachycardia	FLU3~SANOFI PASTEUR~298AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295207	11/01/2007	VA	53.0	53		F	11/01/2007	9:30 am received vaccine - Fluzone; about 8 hrs after became dizzy, nauseous, diaphoretic for 2 hrs; resolved without medications.  no redness, tenderness, or swelling at injection site.  NOTE:  has had flu vaccine in the past - # doses unknown									Y	10/23/2007	10/23/2007	0	n/a	PUB	PUB	Cymbalta; B12 injection	n/a	n/a		VA07:021	1						1	Dizziness; Hyperhidrosis; Nausea	FLU3~SANOFI PASTEUR~U2523AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295208	11/01/2007	TX	29.0			M	11/01/2007	I am an internal medicine resident at medical center.  2 weeks ago I received the Flumist.  I developed some upper resp. symptoms and malaise. Within a week I developed a macular rash that I self diagnosed as pityriasis rosacea.  Rash was limited to torso in a centripetal pattern. Not itchy.  Rash is now resolving.									Y				Pityriasis Rosacea; no labs drawn.	UNK	UNK	none	no	none			1						1	Malaise; Pityriasis rosea; Rash macular	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0295209	11/01/2007	VA	60.0	60		F	11/01/2007	9:30 am received vaccine, about 12 hrs later felt dizzy, sleepy, after 20-30 minutes of sleep awoke diaphoretic - felt hot & sweaty for about 2 hrs; no redness or swelling at injection site, recovered next am.  NOTE:  has had flu vaccine in the past (# doses unknown) without problems.									Y	10/23/2007	10/23/2007	0	n/a	MIL	PUB	n/a	n/a	n/a		VA07:022	1						1	Dizziness; Feeling hot; Hyperhidrosis; Somnolence	FLU3~SANOFI PASTEUR~U2523AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295210	11/01/2007	VA	48.0	48		F	11/01/2007	Received vaccine about 11 am; within an hr, developed quarter sized hard knot at injection site, area tender & became unable to raise LA without difficulty.  Experienced nausea & malaise for remainder of evening.  The next day arm slightly tender, symptoms completely resolved in 36 hrs.									Y	10/23/2007	10/23/2007	0	n/a	MIL	PUB	n/a	n/a	n/a		VA07:023	1						1	Injected limb mobility decreased; Injection site induration; Injection site pain; Malaise; Nausea	FLU3~SANOFI PASTEUR~U2523AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295212	11/01/2007	CA	23.0	23		M	11/01/2007	Patient presented on 10/24/2007 to ER 8 days post vaccination series as listed in #13.  Per ER report he noted approx 4 days previously (20 Oct) to have began experiencing redness and swelling in L-deltoid vaccination site, along with vague malaise and achiness.  Day prior to ER presentation he noted obvious enlarging redness and small ulceration.  Additional symptoms included chills.  Upon ER presentation it was noted that he was afebrile but had elevated WBC (11.4)--he was treated with IV ABX (Unasyn 3 gm), Toradol for his achiness, and sent home for ER follow-up in am.  He returned the next day with reported high fever, aching, chills, and per his wife weak, shortness of breath, confused during night. T-101, P-120, R-18 BP 140/87.  ER doctor felt he was toxic appearing upon this presentation.  Other clinical findings include diaphoretic, mild-moderate ill appearing, erythematous tonsillar pillars with positive exudate, shoddy anterior adenopathy, L-supraclavicular adenopahty, L-deltoid 10 X 8 cm erythema that surrounds a 1 cm ulcerated area with lymphangitis extending to shoulder, marked L-axillary adenopathy.  Patient was then transferred to Medical Center for inpatient care and further evaluation.  Upon arrival patient was stable, non-toxic appearing with vitals: T-97.5, R-18, P-86,  BP-139/86 P/O-100% RA.  L-deltoid erythema noted to be 9cm X 8cm with 1cm ulceration at vaccination site with lymphangitis extending superiorly onto shoulder.  Adenopathy was noted bilaterally shoddy anterior cervical, L-supraclavicular, and moderate L-axillary.  Bilateral tonsillar pillars noted to be erythematous, no exudates, no petichia noted.  Marked improvement in symptoms by hospital day 1 noted (post vaccine day 10).  Upon admission patient was placed on Contact Isolation, IV fluids for hydration secondary to increased creatinine until it normalized, IV AB-Unasyn continued until results returned coag neg staph (wound culture), and blood cultures negative.  An ECHO was perfomed and consultation was obtained with Cardiology immediatly upon patient arrival given elevated troponin--diagnosis was given for myopericarditis (mild) secondary to small pox vaccination given elevated troponin.  Patient was treated with 7 days of Ibuprofen 600mg every 6 hours.  Contact was made with Health Center  and recommendations for myopericarditis protocol initiated to include cardiology follow-up.  Patient was discharged on HD #3 when troponin was trended down and under the normal range as per protocol.  During presentation and hospitatlization denied any symptoms of chest pain/discomfort, no shortness of breath or difficulty breathing.  Planned follow-up includes Hospital follow up in 1 week, Cardiology follow-up in 4 weeks, follow-up Medical Center or Medical Center-- Health Care Center.				Y	Y				Y	10/16/2007	10/24/2007	8	WBC (10/24)-11.4, (10/25)-11.4, neutrophils-83%, creat-1.2 (10/25), trop I- 0.08 (10/25 @ 0850), trop I-0.53 (10/25 @ 1112), wound culture gram positive cocci-coagulase negative on final reading.  EKG in ER significant for sinus tachycardia rate 113, per dictation right axis deviation, no ST segment changes--a second EKG was performed, NSR and no ST segment changes. Blood Cultures were completed and found to be negative.  Rapid strep and throat culture were completed and found to be negative for group A streptococcus. (These are abnormal labs from civilian ER.  Labs from Medical Cnt (abnl)-- trop I: (10/25 @ 1711)-0.893, (@ 1839)-0.774, (@ 2256)-0.555, (10/27 @ 0645)-0.429, (10/28 @ 0750)- 0.089; CRP-US: (10/25)--10.18, (10/27)-4.78, (10/28)--2.86; Creat: (10/25@ 1711)--1.1, (10/26 @0645)-0.9, (10/27 @ 0645)-1.0, (10/28 @ 0750)--0.9; WBC: (10/25 @ 1711)-10.2 (neutrophils 80.9%), (10/26 @ 0645)-6.8, (10/27)-6.2, (10/27)-6.2, (10/28)-6.2.  EKG--Normal Sinus, normal EKG.  ECHO--EF 54%, Trace Tricuspid insufficiency, Estimated PA pressure 27mmHg, L-ventricle normal size, normal systolic function, normal wall thickness, no regional wall motion abnormalities.  Chest PA/Lat-no evidence of acute/active disease process.	MIL	MIL	None	None reported	Morphine (Anaphlaxis)			1						1	Asthenia; Blood creatine phosphokinase increased; Blood creatinine normal; Blood culture negative; C-reactive protein increased; Chest X-ray normal; Chills; Confusional state; Culture throat negative; Culture wound positive; Drug hypersensitivity; Dyspnoea; Echocardiogram abnormal; Electrocardiogram ST segment elevation; Electrocardiogram abnormal; Hyperhidrosis; Inflammation; Injection site erythema; Injection site swelling; Lymphadenopathy; Malaise; Neutrophil count increased; Pain; Pyrexia; Skin ulcer; Streptococcal identification test; Tonsillar inflammation; Tricuspid valve incompetence; Troponin I increased; White blood cell count increased	ANTH~EMERGENT BIOSOLUTIONS~FAV110~1~SC~RA~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500483P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB0994A~2~IM~RA~HEP A + HEP B (TWINRIX)~1|SMALL~PFIZER\WYETH~4020076~1~OT~LA~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~Z11022~1~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Hospitalisation	Influenza
0295213	11/01/2007	OR	80.0	80		F	11/01/2007	If you are tallying adverse reactions to flu shots, you can add mine:  I received a flu shot at my local pharmacy on Tuesday, October 16, 2007.  My reaction was a sore arm, as usual; however, what was not usual was an itching, swollen, red and feverish upper arm, from shot site to elbow--one huge hive.  I treated it with Benadryl spray and internal Benadryl capsules, which gave relief from the itching.  The swelling and redness lasted a long time.  Now, more than two weeks later, there is still residual redness.  I have received flu shots every year since they were first introduced in the 70's.  I always have soreness for a few days, but I have never had a hive reaction before.  Just thought you would like the input.									Y	10/16/2007	10/17/2007	1	none	UNK	UNK						1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Injection site urticaria; Injection site warmth; No reaction on previous exposure to drug; Pain in extremity	FLU3~SANOFI PASTEUR~49281038015~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295214	11/01/2007	WA	66.0	66		M	11/01/2007	At 8pm same day of vaccination client began to have severe chilling. At 1am felt hot, temp 103 severe headache. By the next morning temp 100. Severe headache continued through the next day. On the following day client went to see his doctor and was given an Rx for codeine and ibuprofen. Client took both as prescribed x1 and the severe headache subsided.				Y					Y	10/09/2007	10/09/2007	0	None	PUB	PVT	Unknown	None	Unknown			1						1	Feeling cold; Headache; Pyrexia	FLU3~SANOFI PASTEUR~U2443aa*~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0556u~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0295215	11/01/2007	CA	65.0	65		F	11/01/2007	My right upper arm became red, itchy & swollen. I could not move my arm due to severe & constant pain.I called my doctor, who told me to ice the affected area. My arm remained red & swollen for approx. 4days, inspite of applying hydrocortisone cream & ice.I have never had any type of reaction to a flu shot before & this episode was most uncomfortable. My right upper arm remained sore for about 10 days.									Y	10/16/2007	10/16/2007	0		PVT	UNK	Advair;Actonel; Lasix;Ultram ER;Crestor;Singulair	NONE	Asthma;Rheumatoid Arthritis	NONE~ ()~NULL~~In Patient|NONE~ ()~NULL~~In Sibling1		1						1	Erythema; Injected limb mobility decreased; Oedema peripheral; Pain in extremity; Pruritus	FLU3~SANOFI PASTEUR~271 3110979~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295216	11/01/2007	AK	58.0	58		F	11/01/2007	she states she became ill 5 days after receiving the vaccination with nausea, headache, diarrhea. The next day her arm was sore and it progressed to arm numbness, swelling, joint pain in all her joints(knees, hips, fingers). She has missed 3 days of work because of the  pain. She has never had this happen before from a vaccination.									Y	10/25/2007	10/29/2007	4	none	PVT	UNK		none	PCN			1						1	Activities of daily living impaired; Arthralgia; Diarrhoea; Headache; Hypoaesthesia; Nausea; No reaction on previous exposure to drug; Pain in extremity; Swelling	FLU3~SANOFI PASTEUR~U2454AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295219	11/01/2007	TX	56.0	56		F	11/01/2007	pt experienced pain in upper arm 4 hours post vaccination. 8 hours post, pt also experienced red rash and generalized swelling in an approximate radius of 12 inches from the injection site and swelling/rash extending down the arm to a point about 2 inches past the elbow. Pt self treated with BenadrylMotrin until 48 hours post vaccination at which time she was seen at a medical clinic. She received prescriptions for hydroxyzine and for a medrol dose pack.				Y					U	10/30/2007	10/30/2007	0		UNK	PVT	none	none	none reported			1						1	Injection site pain; Injection site rash; Injection site swelling; Hypersensitivity; Injected limb mobility decreased; Injection site pain; Pain in extremity; Rash	FLU3~SANOFI PASTEUR~U2499AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0803U~2~IM~LA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~0803U~1~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0295221	11/01/2007	MN	37.0	37		F	11/01/2007	Received vaccine at 11:45 am on October 30.  Around 1 or 1:30 pm felt like something lodged in throat, followed by tightness in chest and racing heart.  Wasn't sure if it was a reaction, but it got worse and was followed by diarrhea and nausea, and asthma attack.  By 3:30 pm I collapsed in bathroom and coworkers called an ambulance to take me to ER.  I was given anti-nausea medicine en route and at ER.  After meeting with doctor and tests administered, including EKG and blood tests, I was given Benadryl and the throat felt better.  I was also prescribed Prednisone for 5 days.  I left the ER at about 7 pm.  I had to go back to ER at around 11pm due to stomach pains and fever of 101.  I wasn't seen until after 1 am and they did a cat scan of stomach area and found nothing wrong and determined it was probably more of the allergic reaction, so I left at around 2:30 am.  11/2/07 Received t/c from patient/reporter.  States she is feeling somewhat better & able to return to work partial day.  Still on steroids & benadryl.  Has appt w/allergist next week as she has had flu shots many times in past w/o any problems.  11/30/07 Reviewed ER medical records which reveal patient experienced gradual onset of throat tightness & abdominal pain & cramps beginning several hours after flu vax. She had an asthma attack w/subsequent SOB, wheezing & dry cough followed by nausea, diarrhea, malaise & weakness.  Had received flu shots in past w/o problems.  Tx w/antihistamine & symptoms completely resolved.  D/C to home but returned to ER 7 hours later w/worsening RLQ abdominal pain & temp of 101 w/urinary frequency & decreased UO. FINAL DX: acute allergic reaction to influenza vaccine & RLQ abdominal pain, resolving. Per 60 day follow up I had allergy tests done after this event to see if I had afood allergy but everything came back negative so it must have been the flu shot only that caused it.  Follow-up Information 14-NOV-2008: Abstaining from flu shots indefinitely.			Y	Y					Y	10/30/2007	10/30/2007	0	EKG, blood tests, urinalysis all came back okay LABS: EKG showed sinus tachycardia.  CT of abdomen/pelvis WNL.  WBC 11.9 (H), neutros 94.2 (H), lymphs 4.1 (L).  UA sp grav 1.009 (L) w/few bacteria.	UNK	UNK	Ortho Tri Cyclen lo	None	Asthma, spina bifida oculta, reaction to aspirin (nosebleeds), latex allergy PMH: asthma, well controlled.			1						1	Abdominal pain upper; Asthma; Blood test normal; Chest discomfort; Computerised tomogram normal; Diarrhoea; Electrocardiogram normal; Hypersensitivity; Nausea; Palpitations; Pyrexia; Syncope; Throat tightness; Urine analysis normal	FLUX~UNKNOWN MANUFACTURER~unknown~4~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0295226	11/01/2007	WI	60.0	60		M	10/20/2007	Extreme weakness dizziness or sensitivity to motion behavior change - delusions 1/4/08-records received for DOS 10/26/10/29/07-DX:oropharyngeal dysphagia probably related to MS related fatigue but not necessarily a new lesion, weight loss, delirium.  One week history of progressively worsening dysphagia. C/O weight loss, generalized weakness. Neurology concluded that dysphagia is not MS in origin as MRI did not indicate significant worsening of the disease.				Y	Y	3	Y	Y	U	10/08/2007	10/08/2007	0	At onset, tests for infection as cause were taken. 1/4/08-records received-Swallowing study showed mechanical swallowing difficulty. Barium esophagram did not reveal any masses. G tube placed	OTH	PVT	Amantadine; Lisinopril; Omeprazole; Galantamine; Oxybutynin; Hydrochlorothiazide; Levothyroxine; Simvastatin; Mirtazapine		Multiple Sclerosis 1/4/08-records requested-PMH: MS, HTN and GERD.			1						1	Abnormal behaviour; Delusion; Dizziness; Laboratory test; Motion sickness	FLU3~SANOFI PASTEUR~U2464AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0295229	11/01/2007	MI	61.0	61		M	11/01/2007	After flu shot the local area started swelling up and got hardened. Did not spread or came down									Y	11/01/2007	11/01/2007	0		OTH	UNK		None	Unknown			1						1	Injection site induration; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLA294EA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0295231	11/01/2007	UT				M	11/01/2007	Large area of erythema on Rt. deltoid approximately 5 inches long by 4 inches wide. Treatment with Benadryl and cool compresses.									Y	10/30/2007	11/01/2007	2	None	PVT	PVT	None	None	None			1						1	Erythema	FLU3~SANOFI PASTEUR~U2440AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295233	11/01/2007	TX	64.0	64		F	10/05/2007	Welp saucer size right under injection site Flu like symptoms, fever at 102 deg				Y					Y	10/03/2007	10/05/2007	2		UNK	UNK						1						1	Influenza like illness; Injection site urticaria; Pyrexia	FLU3~SANOFI PASTEUR~U2489AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0984u~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0295234	11/01/2007	TX	76.0	76		F	10/05/2007	Red rash, warm to touch. Across bicep touching tricep				Y					Y	10/03/2007	10/05/2007	2		UNK	UNK						1						1	Erythema; Rash; Skin warm	FLU3~SANOFI PASTEUR~U2489AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0984U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0295235	11/01/2007	TX	73.0	73		F	10/03/2007	extremely cold, shivering-flu-like symptoms										10/03/2007	10/03/2007	0		UNK	UNK						1						1	Chills; Feeling cold; Influenza like illness	FLU3~SANOFI PASTEUR~42489NN~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295236	11/01/2007	WI	35.0	35		F	10/30/2007	Pt presents with urticaria on her legs approximately 20 min after her influenza injection. Within 5 minutes had widespread systemic urticaria and rash. Pt received 50mg po Benadryl. Pt transferred to an urgent care where she was monitored and received 25mg IM Benadryl. Pt d/c to home.				Y					Y	10/29/2007	10/29/2007	0		PVT	UNK		No	Seasonal allergies & asthma			1						1	Rash generalised; Urticaria	FLU3~SANOFI PASTEUR~U2499AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295237	11/01/2007	TX	9.0	9		M	10/31/2007	cough, facial flushing/edema, wheezing, SOB epiphora.				Y					Y	10/30/2007	10/30/2007	0		PVT	PVT	No	No	Amoxicillin Allergy			1						1	Cough; Dyspnoea; Face oedema; Flushing; Lacrimation increased; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500487P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~1336U~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0295238	11/01/2007	NY	49.0	49		F	11/01/2007	Swelling and redness at site of injection (R) deltoid; Zoster-like rash on left upper back area, itching and B/L eye irritation.				Y					Y	10/29/2007	10/31/2007	2	Varicella IgM	OTH	PVT	Unknown	None	None			1						1	Blood immunoglobulin M; Eye irritation; Injection site erythema; Injection site swelling; Pruritus; Rash vesicular	FLU3~SANOFI PASTEUR~U2475KA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295239	11/01/2007	CA	26.0	26		F	10/29/2007	26 y.o q rn c/o arthralgias, swelling and facial rash after influenza vaccine and 10/26/07.				Y					Y	10/25/2007	10/26/2007	1		PVT	OTH	Flonase; Motrin prn; Lunesta prn		Medications: Sulfa-> rash; Reglan -> dystonic reactions			1						1	Arthralgia; Rash; Swelling	FLU3~SANOFI PASTEUR~U2453AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295240	11/01/2007	RI	44.0	44		M	11/01/2007	Pt was waiting for 10 min after flu vaccine because it was a question of receiving vaccine for 1st time. Approx 10-15 min after vaccine. Pt. c/o not feeling well color pale diaphoretic. I placed him on the floor in supine position and placed a coat under and over legs. Pt. was pale and diaphoretic 10:35 BP 100/62.				Y					U	11/01/2007	11/01/2007	0		PUB	PUB		Unknown	None			1						1	Hyperhidrosis; Malaise; Pallor	FLU3~SANOFI PASTEUR~U2449AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295241	11/01/2007	NM	12.0	12		F	11/01/2007	Vaccine adm. on 10/29/07-woke up 10/30/07 with arm swollen-red and itchy today 11-1-07 swelling increased but still itchy.									Y	10/29/2007	10/30/2007	1		PVT	UNK		URI	None			1						1	Erythema; Oedema peripheral; Pruritus	FLU3~SANOFI PASTEUR~U2475GA~3~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2427AA~1~UN~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~1246U~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0295243	11/01/2007	CT	35.0	35		F	10/30/2007	Client received flu vaccine on Mon 10/22, by Tue 10/23: she was c/o pain up her arm to neck with a headache. Wed prn she was unable to life her head due to severe neck pain. Thur. she saw her MD who related this to capsulitis and instructed her to use Advil and Claritin for 2 wks Along with PT for 2 wks				Y					Y	10/22/2007	10/23/2007	1	None	PUB	PVT		None	systemic lupus			1						1	Headache; Mobility decreased; Neck pain; Pain in extremity; Periarthritis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80061~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0295244	11/01/2007	MA	50.0	50		F	11/01/2007	Flu shot given at approx 10am within 24 hr (L) arm red, swellign, warm to touch throbbing pain. H/A yesterday and felt flushed. Today slightly better.									N	10/30/2007	10/31/2007	1	None	PUB	PUB	TST; Cyotonel 50mg	Hypothyroidism	None			1						1	Flushing; Headache; Injection site erythema; Injection site swelling; Injection site warmth; Pain	FLU3~SANOFI PASTEUR~U2500AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295248	11/01/2007	IL	67.0	67		M	11/01/2007	Patient was given an extra dose of Flu vaccine .5cc in right arm. Nurse giving injection thought it was Pneumonia.										11/01/2007			None	PUB	PVT						1						1	Overdose; Wrong drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80684~2~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295249	11/01/2007	MI	45.0	45		F	11/01/2007	Injection given at 2:30pm - 9:00pm while at home patient became very pale, heart palpitations almost fainted - ready to call 911 feeling passed 10-15 minutes later - became hoarse and throat tightened up for 15 minutes then was o.k.									Y	10/30/2007	10/30/2007	0	None recent colonoscopy  - normal	PUB	PVT		None	None			1						1	Colonoscopy; Dysphonia; Pallor; Palpitations; Presyncope; Throat tightness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79718~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295250	11/01/2007	OH	39.0	39		F	10/31/2007	Injection around 9:30 am began itching at 10:00 am. Full hives around 10:30, swollen eyes scratchy throat, wheezing. Took over counter Benadryl - no help. Passed out taken to ER - rev'd Epi-pen, IV Prednisone, Benadryl breathing at treatments				Y					Y	10/31/2007	10/31/2007	0	- none - Have to continue Prednisone for 4 days	PUB	PVT	Remicaid; Advair; Lemp; Corgard; Folic acid	None	Allergy - Tylenol; Crohn's disease; SVT; Asthma			1						1	Eye swelling; Loss of consciousness; Pruritus; Throat irritation; Urticaria; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0295251	11/01/2007	TX	46.0	46		F	11/01/2007	anaphylaxis-swollen face, throat tight Given Epinephrine by EMS. Seen in ED D/C home on Medrol dose pack.				Y					Y	10/31/2007	10/31/2007	0		PVT	PVT	None	None	insomnia			1						1	Anaphylactic reaction; Swelling face; Throat tightness	FLU3~SANOFI PASTEUR~U2489AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295254	11/01/2007	PA	10.0	10		M	10/25/2007	Sterile abscess over site of injection, with an approximately 4 x 4cm indurated center and 6 x 6 cm erythematous area.				Y					U	10/23/2007	10/24/2007	1		PVT	UNK		None	None			1						1	Injection site abscess sterile; Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1336U~UNK~UN~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0295255	11/01/2007	AR	26.0	26		F	11/01/2007	Baseball sized red, hot swollen area on left deltoid.				Y					U	10/31/2007	10/31/2007	0		OTH	UNK	None		Sulfa allergy			1						1	Erythema; Skin warm; Swelling	FLU3~SANOFI PASTEUR~U2530AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295256	11/01/2007	SC	19.0	19		F	10/25/2007	Approximately 12 hours after Flu shot, whole body itching and bilateral hand swelling Tx'd with Zyrtec and improved.									Y	10/24/2007	10/25/2007	1	None	OTH	PUB	Zyrtec 10mg	None	None			1						1	Oedema peripheral; Pruritus generalised	FLU3~SANOFI PASTEUR~U24574A~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295257	11/01/2007	OH	44.0	44		F	10/27/2007	Generalized itching, reddened skin, flat rash; areas on chest and neck- large (5 inches diameter) and red. Patient took 25mg Benadryl per her request. 1500 redness and itching subsiding, not completely gone. Took 25mg Benadryl at home in a.m.									Y	10/26/2007	10/26/2007	0	None	PUB	PVT	MOTRIN; MOBIC; ADVAIR; ZANAFLEX; DETROL; TRILEPTAL; VICODIN; MAXIDE; LUNESTA	None	Penicillin allergy			1						1	Erythema; Pruritus generalised; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA280CA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0295258	11/01/2007	VA	5.0	3		F	10/23/2007	Erythema, induration at site of injection									Y	10/17/2005	10/18/2007	731		PVT	PVT		None	None			1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U2436AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295259	11/01/2007	NH	44.0	43		F	10/25/2007	Approximately 12 hours after vaccine, noted discomfort and redness around but more distal to injection site. Denies swelling in area. 36 hours after injection reported red area 4 1/2 x 2 in size - still no swelling just hot and red. Reported to PCP. Took Ibuprofen prn.									Y	10/23/2007	10/23/2007	0	None	PVT	PVT	Synthyroid	None	Thyroid problems			1						1	Injection site discomfort; Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U2507AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295320	11/02/2007	FL	0.5	0	.5	M	11/02/2007	Fould smelling loose stools, associated with nasal congestion. No fever or vomiting noted.									Y	10/18/2007	10/30/2007	12	None	PVT	PVT		None.	Mild hyperbilirubinemia at birth.			1						1	Abnormal faeces; Diarrhoea; Nasal congestion	DTAP~SANOFI PASTEUR~C2765AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2459PA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B70143D~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0973U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0295322	11/02/2007	FL	36.0	36		F	11/02/2007	Patient reports that she broke out in a rash, three hours after receiving the flu vaccine.  Rash was on face, arms, and neck.  It appeared as small raised red bumps that did not itch or cause any other discomfort.  Vaccine administrator recommended that the patient see her primary care physician.  To date the patient has not seen a physician.									Y	10/30/2007	10/30/2007	0	NA	UNK	UNK	Birth Control Pills	None	None Known			1						1	Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0295327	11/02/2007	GA	49.0	49		F	11/02/2007	Diaphoretic and reports dyspnea 15 minute after Fluarix flu vaccine administration. Lot# AFLUA298BA. Treated with Epinephrine 0.3 mg IM injection and transported by ambulance to Emergency Room.				Y					U	11/02/2007	11/02/2007	0		PVT	UNK						1						1	Dyspnoea; Hyperhidrosis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA298BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0295330	11/02/2007	NC	44.0	44		F	11/02/2007	On 11-1-07 received flu vaccine and noted left arm with pain, burning, itching, warm to touch area of 6 X 2 cm.  Advil taken with ice applied.									Y	11/01/2007	11/02/2007	1	na	PVT	PVT		na	allergies to tagamet, PC, Z-pak			1						1	Burning sensation; Pain in extremity; Pruritus; Skin warm	FLU3~SANOFI PASTEUR~79720~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295331	11/02/2007	FL	8.0	8		M	11/02/2007	Croup began the evening he received the flumist vaccine. 11/09/2007 MR received for DOS 10/31/2007 for D/C DX of Croup.  Pt presented to ER with abrupt onset of inspiratory stridor which responded quickly to racemic epinephrine and steroids. Transfered to current facilty where pt has not required any additional epi. Discharged on steroid taper. PE (+) respiratory stridor, otherwise WNL. Impression: Croup					Y	1			Y	10/30/2007	10/30/2007	0	Labs and Diagnostics:  CXR with streaky interstitial pattern bilaterally with steeple sign.	UNK	UNK			has history of seasonal asthma, patient has cough variant asthma. PMH:  Similar illnesses/events several times in past.  NKDA.			1						1	Croup infectious	FLUN3~MEDIMMUNE VACCINES, INC.~500486PIN~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0295332	11/02/2007	NC	30.0	30		F	11/02/2007	On 11-1-07 pt. received flu vaccine and noted pain, redness, nodule, warm to touch 5 X 4 cm area to left arm.  On 11-2-07 reassessed area and noted 4 X 2 cm area remains painful, nodule and warm to touch.									Y	11/01/2007	11/01/2007	0	na	PVT	PVT		na	iodine allergy,			1						1	Erythema; Nodule; Pain; Skin warm	FLU3~SANOFI PASTEUR~79720~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295333	11/02/2007	MI	13.0	13		F	11/02/2007	Pt. awoke 11/01/2007 approximately 0700 to discover 1cm bulla-appearing lesion on L upper arm which had a small rim of erythema surrounding it. Entire area of upper arm tender to touch.									N	10/30/2007	11/01/2007	2	None	PVT	PVT	None	None	None			1						1	Blister; Erythema; Skin lesion; Tenderness	FLUN3~MEDIMMUNE VACCINES, INC.~500491P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U2538AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2862AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0295334	11/02/2007	PA	40.0	40		F	11/02/2007	24 hours after vaccine the person developed hives over entire body to include palms of hands and feet. 48 hours later body hives continued and developed hives on face and tongue, eyes and lips swollen.  Took Benadryl with some releif of symptoms Denied any use of new products or food or changes in enviroment.									U	10/30/2007	10/31/2007	1		PUB	PVT	NONE	NONE	None			1						1	Eye swelling; Lip swelling; Urticaria	FLU3~SANOFI PASTEUR~79896~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295335	11/02/2007	KY	33.0	33		F	11/02/2007	After administration of the flu vaccine, my heart rate escalated into the 130s within 5-7 minutes.  I was very short of breath and my throat felt as if it was closing off. An IV was started at the clinic and Benadryl 50mg IM was given, O2 per mask was given, all without relief of symptoms. 911 was called and the paramedic took me to the local hospital with an EKG reading of sinus tachycardia 150-160s.  I had uncontrollable shaking and trembling throughout the entire time.  I was given additional Benadryl 50mg IV, Solumedrol, Albuterol treatment and Ativan 2mg at the hospital where I remained on the heart monitor for 4 hours with heart rate remaining in the 140s.  Was discharged after my heart rate dropped to 91.				Y					Y	10/26/2007	10/26/2007	0	EKG	UNK	UNK	Valium 10mg, Cymbalta 90mg, Neurontin 300mg tid, and Ambien CR 12.5mg PRN	Nothing	Latex allergy, environmental allergies, depression and anxiety			1						1	Dyspnoea; Electrocardiogram; Heart rate increased; Oxygen supplementation; Sinus tachycardia; Throat tightness; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA029AA~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0295336	11/02/2007	NC	29.0	29		F	11/02/2007	on 11-1-07 pt. recevied flu vaccine and noted     3 X 1 1/4 redden, nodule, warm to touch, and painful to left arm.  No relief with Mobic or ice. On 11-2-07 reassessed area; now 4 X 2 cm.									Y	11/01/2007	11/01/2007	0	na	PVT	PVT		na	Levaquin and Tylenol allergies			1						1	Erythema; Nodule; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~79720~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295338	11/02/2007	WY	56.0	56		F	11/02/2007	Broke out with shingles at the injection site. Treated with Famvir 500 mg tid for 7 days.									Y	10/18/2007	10/19/2007	1	n/a	PVT	PVT	Albuterol, Celexa, Prometrium, Armour Thyroid, Reglan, Dyazide, Prilosec	n/a	Allergic to Demerol.  Depression, GERD, Asthma, Menopausal, Gastroparesis			1						1	Herpes zoster; Injection site reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA064AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|VARZOS~MERCK & CO. INC.~0620U~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0295340	11/02/2007	OK	1.17	1	.1	M	11/02/2007	Patient was given flu mist. Patient has no symptoms at this time.									Y	11/02/2007			n/a	PUB	PUB		no				1						1	Inappropriate schedule of drug administration; Wrong drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~5004909~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0295346	11/02/2007	MN	0.25	0	.3	M	11/02/2007	Child is uncomfortable and having diarrhea. Was seen back in Clinic on November 2nd. CDC adverse effects for vaccines were reviewed with mother.Mother was informed that child was given flu shot earlier than the 6 month recommended age.									U	10/30/2007	11/02/2007	3		PVT	PUB						1						1	Diarrhoea; Discomfort; Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~UT2459NA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295347	11/02/2007	CA	75.0	75		F	11/02/2007	Patient's right arm became swollen, red, and hot several hours after receiving her flu vaccine. She returned to the clinic the next morning and was given 80 mg of depomedrol, IM, for the inflammation.									Y	10/23/2007	10/23/2007	0		UNK	PUB	CYMBALTA 90MG, LORAZEPAM 1MG, AVAPRO 75MG, PLAVIX 75MG,FUROSEMIDE 20MG, THYROXINE 100MCG, POTASSIUM 8MG, AND VICODIN 5/500MG.	DEPRESSIVE DISORDER, GEN ANXIETY, AND MILD DEMENTIA.	PCN, CODEINE, SULFA, ERYTHROMYCIN, AND MORPHINE.			1						1	Erythema; Inflammation; Oedema peripheral; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA319AA-P~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0295348	11/02/2007	MN	3.0	3		M	11/02/2007	Patient received flu shot 2 weeks apart instead of 1 month apart									Y	10/25/2007				PVT	PUB		NO				1						1	Inappropriate schedule of drug administration	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B056BA~2~IM~UN~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2457FA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295349	11/02/2007	CA	0.33	0	.4	F	11/02/2007	UNKNOWN									U	10/26/2007			UNKNOWN	PUB	PUB	NONE	NONE	NONE			1						1	Inappropriate schedule of drug administration; Unevaluable event; Wrong drug administered	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B124CA~2~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2459NA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UFO67AA~2~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B54007C~2~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1114Y~2~IM~UN~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0295351	11/02/2007	IN	73.0	73		M	11/02/2007	Nov 1st patient experienced chills, diarrhea, vomiting, temperature 100' the evening after receiving vaccination. 911 was called and patient evaluated by emergency response team. Nov 2nd patient experiencing sweating. Instructed daughter to increase patients fluid intake to prevent dehydration and monitor condition.									U	11/01/2007	11/01/2007	0		PUB	PUB				non specified~ ()~NULL~~In Patient		1						1	Body temperature increased; Chills; Diarrhoea; Hyperhidrosis; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLAO31AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0295404	11/02/2007	VA	75.0	75		F	11/02/2007	The patient states that over the last one to two days she has noticed a marked proliferation of tiny red spots all over her body. She also points out a blood blister on the buccal mucosa and she has had some nosebleeds. She is also bruising more easily. There is no prior history of this. She has a granddaughter who has had platelet disorder. Appears in no acute distress. Temp-97.7. Pulse-80. Blood pressure-130/80. The patient has diffuse petechial rash most marked on the lower extremities. There is an approximately silver-dollar sized hematoma in the right buccal mucosa. There was some purplish discoloration on the back of one hand, but no frank ecchymoses. Probable thrombocytopenia. 11/6/07 Reviewed hospital medical records which reveal patient experienced diffuse petechiae, blood blisters x 3-4 days & nose bleed x 1 day when seen in clinic 10/24/2007.  Admitted 11/2-11/4/2007.  Tx w/IVIG x 2 & steroids. FINAL DX: ITP. 12/21/07 Reviewed pcp medical records which reveal patient experienced marked proliferation of tiny red spots all over body x 2 days when seen in office 10/23/07.  Also w/blood blister on buccal mucosa, nosebleeds & easy bruising.  Dx of probable thrombocytopenia.  Referred to hematologist & labs done. When seen 11/13 had be on IVIG & steroids for ITP, possibly related to flu vax.  IVIG failed by 11/29 visit & was being tx w/Rituxan x 4 doses & steroids.  Initially responded to tx but by 12/6/07 splenectomy recommended.  When seen initially by hematologist on 10/24, direct admit to hospital for IVIG x 2.  Bone marrow biopsy done.  D/c home on continued steroids & home infused IVIG weekly. Referred to surgeon for possible splenectomy. FINAL DX: severe thrombocytopenia.					Y	2			N	10/10/2007	10/20/2007	10	CBC, CMP, PT, PTT and ANA LABS: platelets 14,000.  Bone marrow biopsy revealed reactive disease c/w ineffective thrombopoiesis or peripheral destruction of platelets. LABS:  10/23 plts 3K. Bone marrow biopsy revealed megakaryocytic hyperplasia.  Plts 10/26 48K.	PVT	PVT	SYNTHROID; ZYRTEC; HCTZ/ Triam; Sonata; Vitamin		Chronic fatigue; LBBB; Hypothyroidism; HBP; NKDA PMH: HTN, IBS, sleep disorder, hives (dermagraphia),hand tremor x 2 yrs, L>R.  depression.  Granddaugher w/platelet disorder.			1						1	Activated partial thromboplastin time; Antinuclear antibody; Contusion; Epistaxis; Full blood count; Haematoma; Mouth ulceration; Petechiae; Prothrombin time; Rash macular; Skin discolouration; Thrombocytopenia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA055AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation	Influenza
0295405	11/02/2007	MO	21.0	20		F	11/03/2007	Headache/ GI upset									Y	11/03/2007	11/03/2007	0	None	MIL	MIL	None	None	Frequent H/A	unknown 4 days after injection patient allergy~Vaccine not specified (no brand name)~UN~0.00~In Sibling		1						1	Abdominal discomfort; Headache	FLUN3~MEDIMMUNE VACCINES, INC.~500496P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB143~2~IM~RA~HEP A (HAVRIX)~1	USA		Influenza
0295406	11/02/2007	CA	25.0	23		F	11/03/2007	Patient received vaccine then 5 minutes later developed shaking, anxiety and tongue swelling. Within 24 hours, the patient developed bells palsy.				Y					N	11/02/2007	11/02/2007	0		PVT	OTH	None	See #7	None			1						1	Anxiety; Facial palsy; Swollen tongue; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79489~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0295407	11/02/2007	VA	65.0	65		M	11/03/2007	Local development of itching/ hives 10cm diameter around the injection site. No known allergies or reactions in previous years I am not allergic to eggs.									Y	10/17/2007	10/20/2007	3		OTH	OTH	Zastoretic 20/25; Cartia XT	None	High blood pressure controlled			1						1	Injection site pruritus; Injection site urticaria; No reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~U2491AA~7+~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295408	11/02/2007	CA		62		F	10/31/2007	Pain, redness, swelling at injection site - left deltoid. Area was slightly bruised. Patient was feeling ok after injection and BP 102/62 Pulse 64 Resp. normal instructed client on 5/5 of allergic reaction and if injection site swelling or edema does not improve to see MD - called patient 3 hours after injection site given and patient said injection site had improved - not as swollen and was feeling fine.									Y	10/31/2007	10/31/2007	0		PUB	PUB		None	History of cancer			1						1	Injection site bruising; Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2498AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295409	11/02/2007	NV	28.0	28		F	11/01/2007	Pain and stiffness of left deltoid warm erythematous circular area measures 5cm approximately 4cm inferior to the injection site.										10/30/2007	10/31/2007	1		OTH	UNK		None	None			1						1	Injection site erythema; Musculoskeletal stiffness; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~U2504AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295410	11/02/2007	SD	4.0	4		F	11/02/2007	According to the mother, she saw redness around the injection site about 24 hours after the Flu shot was given. On Thursday 11/1 the girl complain of her arm hurting. A baseball size area of redness was noted and it was warm to touch.				Y					U	10/31/2007	11/01/2007	1	None	PUB	UNK	Unknown	Unknown	Unknown			1						1	Injection site erythema; Pain in extremity; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80959~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0295411	11/02/2007	NC	0.7	0	.7	F	10/31/2007	Developed red, painful rash which then developed peeling in flexor surfaces on face. Presumed staph scalded skin syndrome. + staph culture skin, but scant. Rx'd with Keflex. Presumed duration 10 days				Y					Y	09/25/2007	09/30/2007	5	+ SKIN CULTURE - STAPH	PVT	PUB	None	None	None			1						1	Culture positive; Pain; Rash erythematous; Skin exfoliation; Staphylococcal skin infection	FLU3~SANOFI PASTEUR~U2458BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295412	11/02/2007	KS		72		M	11/02/2007	Pain, soreness, swelling left arm - redness - left upper arm extended to forearm. Persisted up to 5 - 7 days. No symptoms at present 10-18-07 onset within 1-2 hours after the vaccines.									Y	10/18/2007	10/18/2007	0		PUB	PVT	PLAVIX; ZETIA; ZOCAR; TROPNOLOL; baby aspirin  - per client	No per client				1						1	Erythema; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2490AA~6~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0555U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295413	11/02/2007	NC		6		F	11/02/2007	Red rash all over body.									N	11/01/2007	11/02/2007	1	CBC; Blood culture; BMP	PVT	PUB		Infectious mononucleosis	None			1						1	Blood culture; Full blood count; Metabolic function test; Rash erythematous; Rash generalised	FLU3~SANOFI PASTEUR~U2508AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295414	11/02/2007	CA	57.0	57		F	11/02/2007	Site of injection with swelling to size of a one ball, purple in color, warm and tender to touch on 11/01/07 after receiving injection on 10/31/07. 11/2/07: states decrease today. Called MD but couldn't get in.									U	10/31/2007	10/31/2007	0	None	PUB	UNK	Lotensin; ASA 81mg; HCTZ; Estrogen	None	hypertension			1						1	Injection site discolouration; Injection site pain; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79489~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295415	11/02/2007	NJ	30.0	30		F	11/02/2007	Received Flu vaccine on 10/26/07 during day. On 10/29/07 reported she developed hives on the evening of 10/26/07. 10/29/07 hives observed on both arms with itching. Tr: Medrol dose pack, Claritin, Benadryl. Resolved.				Y					Y	10/26/2007	10/26/2007	0		OTH	PVT						1						1	Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA313CA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0295416	11/02/2007	RI	1.0	0	1	M	11/02/2007	On 19 October 2007 patient received MMRV, on 26 October 2007. Generalized lesions developed, on 2 November 2007 lesions have scabbed over.									Y	10/19/2007	10/26/2007	7	None	MIL	MIL	None	1 year well baby	NKDA; Trisomy 21			1						1	Scab; Skin lesion	FLUX~UNKNOWN MANUFACTURER~UT2459KA~UNK~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB206BA~2~IM~RL~HEP A (HAVRIX)~1|HIBV~MERCK & CO. INC.~0258U~UNK~IM~LL~HIB (PEDVAXHIB)~1|MMRV~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B70143C~UNK~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0295417	11/02/2007	IL	6.0	6		M	10/30/2007	5:10pm noted to be scratching with single hive on back, diphenhydramine given 5:20pm noted to be wheezing, Albuterol nebulizer given 5:45pm wheezing continues, Prednisone given 6:00pm wheezing improved but still present, transported to ER from clinic				Y					Y	10/26/2007	10/26/2007	0		OTH	UNK	None	None	asthma, allergy to gill fish	hives~DTaP (no brand name)~5~4.00~In Patient		1						1	Pruritus; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U2499AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB141AA~1~IM~LA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~3025U~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0295419	11/02/2007	CA	32.0	32		F	10/22/2007	Pain, erythema injection site x 4 days. No treatment.									Y	10/15/2007	10/16/2007	1		OTH	UNK	None currently	None	No chronic conditions. No food allergies. Med allergy - BENADRYL			1						1	Injection site erythema; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA0522AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0295420	11/02/2007	CA	38.0	38		F	10/22/2007	Pain, ecchymosis, erythema, warmth at injection site. Tylenol for pain prn.									Y	10/15/2007	10/16/2007	1		OTH	UNK	Also taking Wellbutrin	s/p pleurisy off antibiotic	Chronic pain - fibromyalgia			1						1	Injection site haemorrhage; Injection site pain; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA0522AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0295421	11/02/2007	CA	50.0	50		F	10/22/2007	Erythema, edema, warmth, fluid filled vesicles at injection site. Clear fluid in vesicles saw PCP- offered antibiotic - never took. Blisters resolved.									Y	10/15/2007	10/16/2007	1		OTH	UNK	SYNTHROID; ZOLOFT; CORGARD; CLARITIN	None	Skin allergies; nasal allergic rhinitis; seasonal allergies			1						1	Blister; Injection site erythema; Injection site oedema; Injection site vesicles; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA0522AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0295422	11/02/2007	ME	20.0	20		F		After receiving shot, patient became very light-headed and dizzy. She actually lost consciousness for a few seconds. Paramedics were called and her blood pressure was 74/49. They took her to the hospital and gave IV fluids. Her blood pressure stabilized and she was sent home.				Y					Y	10/27/2007	10/27/2007	0	NKA	OTH	PVT	None	None	None			1						1	Dizziness; Loss of consciousness	FLU3~SANOFI PASTEUR~U2524AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295423	11/02/2007	VA	10.0	10		F	10/29/2007	10 minutes after administering vaccine noted redness approximately 5-6 cm at site no edema or respiratory distress noted - noted blotchy redness on arms and flushed cheeks at 1300 spoke with mother redness resolved									Y	10/29/2007	10/29/2007	0		PUB	PUB	K+ Citrate 1000mcg PO BID	None	History of E Coli 12/98 resulted in hypertension			1						1	Flushing; Injection site erythema; Rash macular	FLU3~SANOFI PASTEUR~U2523AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295424	11/02/2007	IL	33.0	33		F	10/19/2007	Developed annular erythema and edema and pain inferior to injection site 2 days after vaccination which increased in size on day 3. Referred to primary MD. To be seen by doctor on 10/19/07.				Y					U	10/16/2007	10/18/2007	2		OTH	PUB		None	BACTRIM			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U2486AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295433	11/02/2007	VA	40.0	40		F	10/26/2007	Patient felt very lighthead, found herself stumbling, was very nausea, passed out, 911 was called on 10/24/07 at 1200 pm ambulance came to get her BP 140/80, P 48 - took to hospital - continuously vomiting - did pregnancy test, brain scan, lung X-ray, gave IV Phenergan 2 shots on hips, sent home 3 meds later that night - was out of work for 3 days not including the weekend.				Y					Y	10/23/2007	10/23/2007	0	EKG; Lung X-ray; Brain scan; Pregnancy test; BG check	OTH	PVT	None	None	None			1						1	Blood glucose; Dizziness; Electrocardiogram; Gait disturbance; Heart rate decreased; Loss of consciousness; Nausea; Pregnancy test; Scan brain; Vomiting; X-ray	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80062~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0295352	11/03/2007	CA	69.0	69		M	11/02/2007	Afternoon and evening of injection there were no problems.  Early evening of next day, I experienced upset stomach and vertigo.  A few hours later, vomiting occurred.  Then went to emergency room and later was hospitalized.  Discharged the next day.  Diagnosis was vertigo, dehydration and hyperglycemia.  11/15/2007 MR received for o/n observation 10/25/2007 with DX: Dehydration.  Vomiting.  Vertigo.  Hyperglycemia.  Possible Acute Coronary Syndrome. Pt presented to ER with c/o abdominal pain and vomiting and then vertigo.  Dizziness is worse with standing.  ROS (+) chills and fatigue.  PE WNL.  Cardiac etiolgy r/o. Txd with Zofran and IVF with improvement.				Y	Y	1			Y	10/23/2007	10/24/2007	1	Labs and Diagnostics: EKG-no acute findings.  Troponin (-)x3. CMP (+) for glucose of 221 and BUN 24.  LFTs WNL.  WBCs 13.8.  Carotid Duplex studies show <20%stenosis.  CXR WNL.	UNK	UNK	Lipitor; Lisinopril	None	None. PMH:  CAD s/p CABG, hyperlipidemia, HTN.  NKDA			1						1	Dehydration; Hyperglycaemia; Stomach discomfort; Vertigo; Vomiting	FLUX~UNKNOWN MANUFACTURER~V04.81~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0295354	11/03/2007	AZ	71.0	71		F	11/03/2007	Chills, sneezing, coughing, sore throat, flu like symptoms.  Onset was the evening of 10/27/07 and was full blown by 10/28/07 in the evening time.  11/30/07 Reviewed ER hospital records which reveal patient experienced nausea, abdominal cramping pain, sore throat & bilious vomiting.  Seen in ER on 11/1 & dx w/viral syndrome, d/c to home.  Symptoms continued to worsen & developed cough, congestion, diarrhea & returned to ER.  Exam revealed hypotension & dehydration.  Admitted 11/2-3/2007.  Tx w/IVF & pain meds. FINAL DX: no d/c summary available.  D/C date obtained verbally.  Nausea & vomiting.  Non-obstructive left ureteral stone.				Y	Y	2			Y	10/26/2007	10/27/2007	1	Upper Respitory Viral infection per the ER physician at Hospital on 11/1/07. LABS: CT of abdomen/pelvis revealed kidney stones.	UNK	UNK		None	Allergies PMH: GERD.  Kidney stones, osteoporosis, HTN.  Allergy: penicillin & sulfa.			1						1	Chills; Cough; Influenza like illness; Pharyngolaryngeal pain; Sneezing; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~v2y53aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0295357	11/03/2007	WI	42.0	42		F	11/03/2007	Vaccination received on 11/1/07 = Extreme Chills within and hour after receiving - could not warm up. Later warmed up but hyperactivity began to set in. That night I could not sleep because I was extremely cold and my heart was racing...had a slight fever (100 F) and headache also. Now, two days later I am feeling extremely light-headed and shakey - as though I am going to pass out (body temp is at 97 F).									U	11/01/2007	11/01/2007	0		PUB	UNK		Had been having symptoms of sinus infection earlier in the week. Headaches and sinus pressure.	Penicillin, all family members; peanut allergy; mold			1						1	Chills; Dizziness; Feeling cold; Headache; Insomnia; Palpitations; Psychomotor hyperactivity; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0295358	11/03/2007	SD	2.0	2	.3	M	11/03/2007	No adverse events were reported.  Gave 2 year old client the adult dose of Novartis vaccine instead of child dose of Sanofi vaccine.  Reported to CDC and was told no additional side effects should be expected and dose still counts as a valid dose.									Y	11/03/2007				PUB	PUB		None				1						1	Inappropriate schedule of drug administration; Wrong drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80959~1~IM~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295359	11/03/2007	IN	79.0	79		F	11/03/2007	Severe chills for several hours after vaccination, vomiting.									Y	11/02/2007	11/02/2007	0		UNK	PUB	None	No	Nitrofurantoin, tetracycline, tramadol, biaxin, effexor, fosamax.			1						1	Chills; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA031AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0295360	11/03/2007	FL		42		M	11/03/2007	I have a large red swollen area and extreme pain at the injection site.  Additionally, my head and body ache and it feels like I am running a low grade temperature.                                 Your system does not allow me to enter Bioport was unable to provide you the name of the manufacturer.										11/02/2007	11/02/2007	0		MIL	UNK	I take Zytec-D as needed as well as other supplements	None	Possibly to penicillin			1						1	Body temperature increased; Headache; Injection site erythema; Injection site pain; Injection site swelling; Pain	ANTH~EMERGENT BIOSOLUTIONS~FAV158~6~~LA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U2310AA~7+~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295363	11/03/2007	VA	41.0	41		F	11/03/2007	Right arm celluitis with itching, pain and area very hot to touch.  Overall muscle aches and severe irritablity.  Broken sleep noted due to pressure on site during position change. Site approximately 3inches in circumference of injection site.				Y					Y	10/31/2007	11/01/2007	1		PUB	UNK	WELLBUTRIN, IRON TABLET, ZANTAC, BUSPAR,	NONE				1						1	Cellulitis; Injection site pain; Irritability; Myalgia; Pruritus; Skin warm; Sleep disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA315AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0295364	11/03/2007	VA	49.0	49		F	11/03/2007	11/2/07 1530 SWELLING, REDNESS, HEAT AND THE SIZE OF A GOLF BALL, LIGHT HEADED AND SICK TO STOMACH.11/3/07 0600 SWOLLEN AREA BIGGER, HOTTER AND MUCH LARGER AND STILL VERY PAINFUL. SHOWED IT TO MY NURSE MANAGER AND SUPERVISOR AS WELL AS STAFF FOR ADVICE.  I PUT ICE ON IT BUT NO RELIEF.									U	11/02/2007	11/02/2007	0		PVT	UNK						1						1	Dizziness; Erythema; Pain; Skin warm; Stomach discomfort; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0295365	11/03/2007	MO	55.0	55		F	11/03/2007	received influenza and pneumonia vaccines on 10/30/07 at above mentioned facility between 2:00p and 2:30p. i had been experiencing leg pain that day and the day before, however on 11/1/07 when i awoke at approx 10:00a i experienced numbmess, acheing and needless and pins sensations in my legs and was having trouble walking. i had never had feelings like this in my legs before and it is worsening progressivly everyday. it is now 11/3/07 at approx. 5:00p. i am so off balance i am walking with an old cane we had to get around the house. i am going to the er at the clinic that gave me the shot on monday if this does not improve. if it does i will at least call and report this for their records. i am 55 and have never had a flu shot as i lived in california during the swine flu thing and my boyfriend was a dr's son. the doc recommended that we wait and see which we did and i guess i've been gun-shy ever since. i decided that i'd get one this year as they seemed harmless here lately. i have done some of my own research and believe this could fall into a gbs catagory but have not been to the dr. thank you										10/30/2007	11/01/2007	2		UNK	UNK	topral xl 200mg 1daily, celexa 20mg 1daily, ibuprofen 800mg prn, lortab 10/500 prn	n/a	controlled hypertension, hep c, dyspnea and low o2 sats with exertion and other times,spondylosynthesis, spinal stenosis, disinegrated disk between L-4 to L-5, problems with liver accumulating ammonia, status post cerebral stroke and possible heart attack.			1						1	Gait disturbance; Hypoaesthesia; Pain; Pain in extremity; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~IM~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0295366	11/03/2007	CA	14.0	14		M	11/03/2007	ON  10-22-07 PATIENT'S MOM SAID THAT 6 HOURS AFTER SHOT ON 10-08-07  HAD TEMP OF 104, GAGGING AND SAID THROAT WAS CLOSING.COULDN'T MOVE HIS BODY ,VOMITED AND SAID HE WAS PASSING OUT.HE WAS TAKEN TO THE EMERGENCY ROOM.THE MD SAID HE JUST HAD A FLU AND WAS DISCHARGED NEXT MORNING, NO MED WAS GIVEN				Y					Y	10/08/2007	10/08/2007	0	NONE	UNK	UNK	SINGULAIR, ALBUTEROL	NONE	ALLERGY AND ASTHMA			1						1	Body temperature increased; Dizziness; Hypokinesia; Influenza; Retching; Throat tightness; Vomiting	FLU3~SANOFI PASTEUR~U2453AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295370	11/04/2007	PA	63.0	63		F	11/04/2007	Recieved the shot 11/02/2007 at 12:30pm, by 3:30pm I was very dizzy and weak, Idid not call the Doctor I went and laid down the rest of the evening, I was also nauseated and aches till Sunday 11/04/2007, I had to stay in bed because I couldn't walk a straight line because of dizziness.									Y	11/02/2007	11/02/2007	0		PUB	PVT			heart, high blood preasure, asthma, allergies to outdoors, trees, grass, rag weed, citrus foods			1						1	Asthenia; Dizziness; Gait disturbance; Nausea; Pain	FLUX~UNKNOWN MANUFACTURER~unknown~2~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0295371	11/04/2007	CA	41.0	41		M	11/04/2007	Patient in process of passing out was laid to the floor at 12:00pm.  Patient turned pale, eyes rolled back into head and stopped breathing, code blue was called.  Patient resumed breathing within a few seconds, code blue was cancelled.  Patient administered oxygen and vital signs were taken BP 150/76, HR 52, Res 22.  Code team showed up and patient was talking.  At 12:02pm, vitals were BP 140/76, HR 53, Res 20. 12:04pm patient transported to ER via gurney.				Y					Y	11/04/2007	11/04/2007	0	N/A	MIL	MIL	Unknown	None	Bactrim allergy	Dizziness~ ()~NULL~~In Patient		1						1	Apnoea; Gaze palsy; Pallor; Presyncope	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA049AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|TYP~SANOFI PASTEUR~A0394~3~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0295372	11/04/2007	CA				F	11/04/2007	upper arm numb and felt heavy immediately after administration and for a couple days after administation-no general symptoms only localized to upper arm									Y	10/24/2007	10/24/2007	0		UNK	UNK						1						1	Hypoaesthesia; Sensation of heaviness	FLU3~SANOFI PASTEUR~U2449AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295373	11/04/2007	NY	60.0	60		F	11/04/2007	Sudden very painful hip joints and muscle pain									U	10/31/2007	11/02/2007	2		PVT	PVT			none	none~ ()~NULL~~In Patient		1						1	Arthralgia; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0295488	11/05/2007	NY	25.0	25		F	11/02/2007	Information has been received from a physician concerning a 25 year old female who on 24-OCT-2007 was vaccinated IM with the first dose of Gardasil (Lot #658560/1062U). Concomitant therapy included ethinyl estradiol/norgetimate (TRINESSA), acyclovir (ZOVIRAX) and influenza virus vaccine (unspecified). On 24-OCT-2007 the patient experienced anaphylaxis and rash 5 minutes after vaccination. Subsequently, the patient recovered from anaphylaxis and rash after being treated with 2 shots of Decadron and Benadryl. The physician considered these events to be life threatening. Additional information has been requested.			Y						Y	10/24/2007	10/24/2007	0	diagnostic laboratory - positive herpes antibody	OTH	OTH	ZOVIRAX; TRINESSA		Unknown		WAES0710USA05654	1						1	Anaphylactic reaction; Herpes simplex serology positive; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~1062U~1~IM~UN~HPV (GARDASIL)~1	USA	Life Threatening	Influenza
0295504	11/05/2007	ME	92.0	92		F	11/05/2007	On 11-02-2007 during routine office visit for arthritis and HTN, Flu vaccine given. Pt left the office with no c/o any. She went to shop and few hours later she was brought back in lethargic condition. O2 - 4 Epipen - applied, 911 - called, and she was transported by ambulance to Emergency Room.  12/11/07 Reviewed hospital ER records & death summary which reveal patient experienced severe substernal chest pain & collapsed while shopping 11/2/2007.  EMS took to ER where she developed complete heart block & bradycardia.  Tx w/meds, pacemaker & intubation.  Resuscitated & taken for cardiac cath.  In cath lab, arrested & CPR started.  Developed ventricular fibrillation non responsive to defibrillation & meds & pronounced. 1/11/08 Received death certificate which states COD as ventricular fibrillation, acute MI & ateriosclerotic heart disease.	Y	11/02/2007		Y					N	11/02/2007	11/02/2007	0	? Possible adverse reaction vs. M.I. LABS: EKG revealed acute inferior STEMI	PUB	UNK		Arthritis; HTN	Arthritis; HTN		ME01207	1						1	Lethargy	FLU3~SANOFI PASTEUR~U2502AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0295508	11/05/2007	MI	84.0	84		M	10/30/2007	Pt had v. good dr. appt; had flu shot and stopped for lunch and was very sick before food was delivered. Taken by ambulance to hospital. All within 2 hrs from shot; BP dropped - dry heaves, v. weak.  12/17/2007 MR received for DOS 10/3-6/2007 with D/C Dx:  Syncope and Collapse.  Principal DX: Pre-syncope. UTI. 2' DX: Dehydration.  Pt transported to ER after episode of nausea, vomiting, diaphoresis and light-headedness while eating after flu shot receipt.  Pt reports recent diarrhea with blood. Pt dropped BP on sitting and standing.  Orthostasis resolved with IVF. UTI txd with abx. Pt d/cd to skilled care facility.				Y	Y	3			Y	10/03/2007	10/03/2007	0	All pertain to heart that I know of. Labs and Diagnostics:  CBC with WBCs 10.6, Chemistry unremarkable, UA with 22 WBCs, 4 RBCs and 4 Hyaline casts.  Cardiac enzymes WNL.  EKG-RBBB.  Stress test normal.  HGB 14.2 on admission and 12.1 on d/c.  Stool heme (+).	MIL	UNK		None. Pt reports recent diarrhea with blood.	Heart. PMH:  Type 2 DM, Stroke, CAD s/p CABG and R Carotid Endarterectomy, HTN, hypothyroidism, hyperlipidemia.  NKDA.			1						1	Asthenia; Blood pressure decreased; Malaise; Retching	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0295510	11/05/2007	SC	32.0	32		F	11/05/2007	pt states her arm hurt all day after receiving the shot and has progressively gotten worse.  States unable to reach arm behind back to fasten bra or lift arm above head.  Generalized soreness in muscle.  No redness,heat or swelling noticed.  Denies having fever since receiving shot.									U	10/15/2007	10/15/2007	0	pt given copy of authorization and VIS to take to PMD.  SHe will call PMD today for an appt.	PUB	PUB	BCP and vitamins	none	none			1						1	Injected limb mobility decreased; Myalgia; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78994~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295516	11/05/2007	CA	69.0	69		F	11/05/2007	Hive outbreak, first ever, lasting a week, continuing and subsiding slowly.  Large colorless welts. Benadryl and calamine lotion, oatmeal bath.									U	10/29/2007	10/30/2007	1	Diagnosed with Vasculitis secondary to CLL March 2003, treated with Rituxan, Fludarabine.  The hives occurred where the vasculitis initially appeared.	PUB	PUB	20 mg Peroxicam daily 5 mg Zolpidem daily hyddrocodone/apap5/500 mck as needed daily multivitamin/mineral supplement	none	Vasculitis secondary to atypical CLL/SLL			1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0295517	11/05/2007	NV	71.0	71		F	11/05/2007	Pt states that 30 minutes after administration of flu and pneumonia shots in Left arm, that arm was red, swollen with a hard knot, and by the next day the redness and swelling, and pain had radiated from shoulder to elbow. Was told by MD that it was a staph infection caused by needle or vaccine				Y					Y	11/04/2007	11/04/2007	0	CBC, Antibiotics administered po	PUB	PUB	States on coumadin and several heart meds	Denies	Heart attack, HTN			1						1	Erythema; Full blood count; Nodule; Pain in extremity; Staphylococcal infection; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua294fa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1132U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0295519	11/05/2007	MI	68.0	68		M	11/05/2007	Given PPV-23 vaccine sub-q on 11-2-07. Called health dept this morning and wife said arm got a very large hot red swollen area at injection site and their doctor said go to ER where they diagnosed him with an allergic reaction to PPV23 & ordered benadryl 50mg q 4 hours. Vastly improved now. Never had a fever. Left arm amputated thus flu & PPV in same arm both an same day.				Y					Y	11/02/2007	11/03/2007	1		UNK	UNK	unknown	no				1						1	Hypersensitivity; Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2505AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0962U~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0295520	11/05/2007	WI	2.0	2	.9	M	11/05/2007	Patient received Flu injection in left anterior thigh. Left thigh to below knee is swollen to twice its normal size. Skin in effected area is blotchy red.									U	11/03/2007	11/04/2007	1	None	PVT	UNK	Sodium Fluoride daily	none	Failure to gain weight			1						1	Erythema; Injection site swelling; Rash macular; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U2499AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2499AA~4~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0295521	11/05/2007	VA		37		F	11/05/2007	within 5 minutes of receiving flu mist pt states that she had swelling of her eys, redness and tearing and nasal congestion				Y					Y	01/08/2007	01/08/2007	0		MIL	MIL	unknown	none	allergy to PCN, psoriasis			1						1	Eye swelling; Lacrimation increased; Nasal congestion; Ocular hyperaemia	FLUN3~MEDIMMUNE VACCINES, INC.~500434p~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0295522	11/05/2007	WI	60.0	60		M	11/05/2007	11-1-07 9pm Fever of 101.7 - c/o violent chills that felt like convulsions - joint pain in elbow, shoulder, knuckles, and neck - took aspirin before going to bed but does not remember exact time.  11-2-07 7:50am  Continues to c/o fever of 100 - back muscles are very sore and joints continue to ache.  Has not taken any further medication. 11-5-07 10am Reports that he is feeling better - no complaints.									Y	11/01/2007	11/01/2007	0		PUB	PVT	Metformin, Glimiperide	None	Diabetes			1						1	Arthralgia; Chills; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U2445AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295524	11/05/2007	TX	3.0	3		M	11/05/2007	Within 24 hours severe congestion and cough.  Cough continually worsened into an allergic reaction as diagnosed by doctor.  To date the condition has become progressively worse with the child coughing at intervals of every 15 seconds, constantly.  Ventilation and allergy medication now presecribed by physician.  Follow up in two days.  If worsening or no progress - Specialst care will be required. Condition has now existed for 10 days and has increased in severity.				Y					N	10/26/2007	10/26/2007	0	TBD	PVT	PUB	none	none - healthy	none	none~ ()~NULL~~In Patient		1						1	Cough; Hypersensitivity; Respiratory tract congestion	FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0295525	11/05/2007	RI	49.0	49		F	11/05/2007	I was vaccinated with the flu vaccine at my local ymca at 9:00 a.m. on Saturday morning.11/03/2007.Shortly thereafter shot was administered on 11/04-2007 during the night,began experiencing severe allergic respiratory symptoms.Wheezing,whistling,coughing,chest congestion,etc.I have not experienced this for the last 3 yrs,since I stopped smoking.It felt bad.The same way I felt upon quitting.I did report it to my health care provider who suggested cough medicine as treatment.Will call back to double check on symptoms.Hopefully they will only be a couple of days duration.I thought I would report said symptoms.I am a single female 49 yrs of age.I do not smoke and have not done so in 3 yrs.									Y	11/03/2007	11/04/2007	1		UNK	UNK	Benicar,Prozac,Oxybutinin,Keppra,Oxaprozin,Lamactal,Ativan		Only allergy to provental cough medicine.			1						1	Cough; Respiratory disorder; Respiratory tract congestion; Wheezing	FLUX~UNKNOWN MANUFACTURER~unknown~1~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0295526	11/05/2007	CA	11.0	11		F	11/05/2007	approximately 2 weeks after vaccine administration developed headache, ataxia, and seizures requiring antiepileptics, steroids, antibiotics.  11/6/07 Received vax records & pcp medical records.  VAERS database updated w/same & date of vax corrected to 10/19/2007. Flu shot not on vax record but ordered on pcp note.  Pcp note of 10/19 indicates patient in good health on day of vax.  Returned to pcp 11/2/07 w/dizziness, fever, HA, slight cough.  Dx w/viral infection.  T/C to provider to clarify vax info.  Received 2nd page of vax record w/flu vax info.  VAERS database updated w/same. 11/30/07 Reviewed hospital medical records which reveal patient experienced HA, vomiting, ataxia & right sided spasticity.  Had HA x 7 days prior to admitl w/increasing ataxia x 3 days.  Admitted 11/2-11/10/2007.  As preparing for LP, patient had seizure & desaturation.  Intubated & admitted to PICU.  Neuro consult done.  Given IV antibiotics & antivirals until cultures came back neg.  Extubated 11/5 & progressed well on antiseizure meds.  FINAL DX: Encephalitis; ataxia; headache.					Y	8	Y	Y	N	10/19/2007	10/27/2007	8	LABS: CT scan WNL.  MRI initially WNL.  Repeat MRI revealed focal lesion in corpus callosum.  MRA of neck WNL. CSF protein 118 (H), WBC 54 (H), RBC 2 (H), lymphs 92% (H), monos 8% (L).  HSCRP 2.05 (H)Blood, urine & CSF cultures neg.  Trach aspirate culture (+) staph aureus (not MRSA).	UNK	UNK		none	none			1						1	Ataxia; Convulsion; Headache; Ataxia; Convulsion; Headache	FLU3~SANOFI PASTEUR~U2435AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0012U~1~~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2208AA~1~~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B013AA~6~~LA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~0127U~2~~LA~VARICELLA (VARIVAX)~1|FLU3~SANOFI PASTEUR~U2435AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|HPV4~MERCK & CO. INC.~0012U~1~UN~LA~HPV (GARDASIL)~2|MNQ~SANOFI PASTEUR~U2208AA~1~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B013AA~6~UN~LA~TDAP (BOOSTRIX)~2|VARCEL~MERCK & CO. INC.~0127U~2~UN~LA~VARICELLA (VARIVAX)~2	USA	Hospitalisation,Disabling	Influenza
0295530	11/05/2007	ME	36.0	36		F	11/05/2007	Starting that evening fever of 101.3, vomiting, diarhea.  Her family doctor recommended fluids and rest and the symptoms stopped after a day.									Y	10/31/2007	10/31/2007	0		UNK	PUB	Klonopin 0.5 qd and prn, birth control pills			fever, vomiting, diarhea~Influenza (Seasonal) (Fluvirin)~NULL~20.80~In Patient		1						1	Diarrhoea; Pyrexia; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80958~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295532	11/05/2007	RI	41.0	41		M	11/05/2007	Patient developed Temperature of 104, left arm redness and swelling 2 days after administration of Pneumovax and influenza vaccines.				Y					U	11/02/2007	11/04/2007	2	Elevated WBC count at Hospital.	UNK	UNK	Lamictal, omeprazole, simvastatin	None	hyperlipidemia, Bipolar disorder, GERD			1						1	Erythema; Pyrexia; Swelling; White blood cell count increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79721~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0880F~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0295535	11/05/2007	IL	65.0	65		F	11/05/2007	Starting 11/4/07 Injection site became red and inflammed, Primary doctor gave her cephalexin 500mg 1qid for ten days				Y					U	11/02/2007	11/04/2007	2		UNK	PUB						1						1	Injection site erythema; Injection site inflammation	FLU3~SANOFI PASTEUR~u2499aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295537	11/05/2007	MD	78.0	78		F	11/05/2007	Husband presented to health dept. today and stated that his wife received the flu vaccine via the gun on Thursday 11-01-07 and her right arm hurt when she got home and he stated it sweeled up and he applied ice.  The next morning it swelled even more and his wife was taken by ambulance to the ER. He stated the hospital said a blood vessel was broken from the use of the Bioject.  This woman had to receive 5 units of blood.Is currently hospitalized and I put 4 days hospitalized, am not sure of total days. Husband as of today, stated his wife was still in the 3/5/08-records received. Assessment hematoma right upper extremity. Anemia. Requiring blood transfusions.  At time of discharge increased movement of right shoulder.PE: right arm swelling and ecchymosis immediately followed vaccine administration. right arm hematoma.Anemia secondary to right arm hematoma. Current medications include Plavix and warfarin.					Y	4			U	11/01/2007	11/01/2007	0	Wife had aortic valve replacement a year ago in April and is taking Coumadin and Plavix, records received 3/5/08-PT and INR increased.	UNK	UNK	currently coumadin and plavix	uses a wheelchair, unknown	Hx of aortic valve replacement 3/5/08-records received-S/P aortic valve replacement, CAD bypass graft surgery. Obesity. Hypertension. OSA. records received 3/5/08- PMH: recent hip replacement. coronary artery disease, aortic valve replacement, hypertensive heart disease, history of obstructive sleep apnea, hypothyroidism, peripheral vascular disease, urinary incontinence, deep venous thrombosis, gastroesophageal reflux.			1						1	Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2486AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0295538	11/05/2007	IL	46.0	46		F	11/05/2007	Pt. Described a bounding irregular heartbeat, weakness, general malaise, no nausea, no dizziness, no respitory distress approx 1 hour post flu shot. Reported to medical department at work. Rested for approx. one half hour with no improvement. EMS called and transported Pt. to hospital. ER Dr. diagnosed as a physiological reaction to the flu shot. Did not DX. an allergic reaction. Sent home from ER With Rx for tylenol prn. Described feeling  fully recovered in 48 hours. Has had flu shots in the past without incident. Spoke with Pt. on 11/5 sx's fully resolved no residual effects.				Y					Y	10/24/2007	10/24/2007	0		UNK	PVT	NA	none	none			1						1	Asthenia; Heart rate irregular; Malaise	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflla031aa~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0295541	11/05/2007	MN	1.6	1	.6	F	11/05/2007	I inadvertently gave patientan adult dose of the Hepatitis A Vaccination. No adverse reactions have been reported to date.									U	11/02/2007	11/02/2007	0		UNK	UNK						1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~ut2459na~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~ahav3115ca~UNK~IM~LL~HEP A (HAVRIX)~1	USA		Influenza
0295542	11/05/2007	WA	66.0	66		F	11/05/2007	hot, swollen tender arm from shoulder to elbow x 4 days									Y	10/23/2007	10/23/2007	0		PVT	PVT	Estradiol, Diovan, Folic Acid, Dyazide, Naproxen, fish oil, glucosamine, Vit. C and multiple vitamin	None	hypertension, osteoarthritis, ankylosing spondilitis, allergic rhinitis			1						1	Oedema peripheral; Skin warm; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~039AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|VARZOS~MERCK & CO. INC.~088541~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0295543	11/05/2007	AZ	61.0	61		F	11/05/2007	patient received pneumovax vaccine and influenza vaccine on 11-04-2007 in the left deltoid with the influenza vaccine dorsal from pneumovax and separated by 1 inch - comes to Clinic today with area around vaccine red warm and raised with area 3cm round - left arm warm with less than 3 secaond capillary refill of all fingernails - pneumovax administered at patient request at the order of patients doctor due to chronic diabetes and lung problems. Recommended patient to go to urgent care to recieve further care with verbalized understanding. First Pneumovax vaccination - instructed patinet to list allergy to pneumovax and phenol for patients further history reporting.									Y	11/04/2007			none - referred to urgent care	UNK	UNK	Metformin, Ultace, Zocor	None	Allergy to mycin drugs and penicillin only, diabetes, chronic asthma, hypercholesterolemia			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA298BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0989U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295546	11/05/2007	CA	54.0	54		F		(L) pain over scapular region and humerus, numbness/tingling on fingers and toes (L) side about 5 day post vac, continued to worsen and intensified till 11/1 and (L) side of entire body = excruciating pain, unrelenting - 11/2 pain and numbness starts up on (R) side - fingers, toes, numb, tingling and (L) eye twitching, tearing and tingling, numbness down to top of cheekbone.									U	10/17/2007	10/21/2007	4	None	PVT	UNK						1						1	Blepharospasm; Hypoaesthesia; Hypoaesthesia facial; Muscle twitching; Pain; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78481~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0889F~2~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295549	11/05/2007	IN	57.0	57		M	10/18/2007	Mild 1) one person vaccination, was writing with pen with gloves on after vaccination, then took off gloves, put on new ones, but picked up pen again before vaccination,    patient 2) another person vaccinating - did not gloves off good for a while preparing another patient I reminded him to do so. My suspicion so thus he did not change his gloves before the vaccinations also he   of gloves was on his side of the left only on the Flu other side.									U	10/18/2007				OTH	PVT						1						1	Unevaluable event	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295551	11/05/2007	MO	26.0	26		F	10/11/2007	Influenza vaccine administered - c/o itching at injection site only. Band aid removed (non-latex) due to history of tape sensitivity, area red at site. Redness decreased after band aid off. Itching onset was immediate. Personal doctor contacted. Benadryl 50mg PO taken.									Y	10/11/2007	10/11/2007	0	None	PUB	PUB	None	None	Allergic reaction x 1 to bee sting			1						1	Immediate post-injection reaction; Injection site erythema; Injection site pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78995~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295553	11/05/2007	CA	66.0			F	10/25/2007	Severe arm pain at pneumococcal vac site, unable to move arm, tx with Advil, Benadryl, Ice.									U				No	PVT	PVT		No	No			1						1	Injected limb mobility decreased; Injection site pain	FLU3~SANOFI PASTEUR~U2512AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295554	11/05/2007	VA	53.0	53		F	10/15/2007	Approximately 2 hours after injection, severe nausea, diaphoretic, hand trembling, heart palpitations, difficulty reading print and typing (using keyboard) difficulty focusing, dizziness, tachycardia, lightheadedness, lasted approximately 3-4 days.				Y					Y	10/03/2007	10/03/2007	0		PVT	OTH	ZANTAC; PRILOSEC; HRT; TENORMIN; CLARITIN; ELAVIL' METHADONE; BACLOTEN	None	Allergies - PCN; Sulfa; hayfever; pollen; GERD; chronic pain syndrome; hypercholesterol; hypertension (mild)			1						1	Disturbance in attention; Dizziness; Hyperhidrosis; Immediate post-injection reaction; Nausea; Palpitations; Reading disorder; Tachycardia; Tremor	FLU3~SANOFI PASTEUR~U2467AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295555	11/05/2007	OH	1.55	1	.5	F	10/29/2007	Patient was given FluMist nasal spray today at age 18 mos (Vaccine is recommended starting at age 24 mos).									Y	10/29/2007			None	PUB	UNK		None	None			1						1	Incorrect drug dosage form administered; Wrong drug administered	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B070AA~1~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500488P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB200AA~1~IM~RL~HEP A (HAVRIX)~1|HIBV~SANOFI PASTEUR~UF108AA~1~IM~RL~HIB (ACTHIB)~1|MMRV~MERCK & CO. INC.~0232U~1~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08679E~1~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0295556	11/05/2007	VA	50.0			F	10/30/2007	generalized rash 24 hrs after vaccine									Y	10/19/2007	10/20/2007	1		PUB	PUB		None	Diabetes Mellitus			1						1	Rash generalised	FLU3~SANOFI PASTEUR~U2440AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295557	11/05/2007	IL	79.0	79		F	10/29/2007	Patient stated that she felt a burning, radiating sharp pain in upper right arm the first 2 days upon receiving the vaccine. By the 4th day, she developed a red raised bump at the injection site approx 4 in diameter. Pt applied heat and took Tylenol as instructed by her physician. Bump began to ooze for several days (pus-like fluid). After several days, bump decreased in size and began to crust and peel around edges. Injection area remained slightly tender and warm x 2 days.									Y	10/09/2007	10/12/2007	3		OTH	OTH		None	Hypercholesterolemia			1						1	Injection site discharge; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pain in extremity	FLU3~SANOFI PASTEUR~U2450AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0200u~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295558	11/05/2007	NV	73.0	73		M	10/19/2007	No c/o at site of injection - developed dimed sized clusters of pustules under same arm, on upper back and chest on same side as vaccine administered. Spots painful to touch as is his upper body on left side. Pt told to go to private MD for diagnosis.										10/09/2007	10/17/2007	8	Pt called back later in day to say his PMD dx him with shingles.	PUB	UNK	Cholesterol med	None	Healthy			1						1	Herpes zoster; Pain; Rash pustular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA294FA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0295559	11/05/2007	OH	66.0	66		U	10/29/2007	Fever Extreme muscle pain at injection site (R arm) (could not lift arm)									Y	10/24/2007	10/24/2007	0		OTH	PVT	None	None				1						1	Injected limb mobility decreased; Injection site pain; Myalgia; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80684~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1381u~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295560	11/05/2007	CA	39.0	39		F	10/28/2007	Awakened by dizziness at 3:00am on Friday October 5. Dizziness and vomiting for 13 hours. Went to the emergency room at hospital. Dizziness lasted through October 7. with occasional dizzy spells the following week.				Y					Y	10/03/2007	10/05/2007	2	CT scan; Blood panel and urine tests	PVT	OTH	None	None	None			1						1	Blood test; Computerised tomogram; Dizziness; Urine analysis; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0295562	11/05/2007	WA	76.0	76		M	10/29/2007	Cellulitis - Evening 10-18-07 hospitalized 1 day. Pneumonia - Evening 10-21-07 Hospitalized 8 days. 1/4/08-records received for DOS 10/25-11/2/07-DC DX: Pneumonia. C. diff. colitis.  Presented to ED with 1 day HX rigors, disorientation.  Temp 102,  Diminshed sounds in RLL. No cellulitis.On day 4 became acutely drowsy and unable to stay awake. . Spiked fevers. Loose stools and history of c. diff.					Y	8			Y	10/18/2007	10/18/2007	0	Cellulitis and Pneumonia diagnosed about 10-22-07. 1/4/08-records received-WBC 12.6. new RLL infiltrate on CXR.Elevated leukocytes. Blood and urine cultures no growth	OTH	UNK		None 1/4/08-records received-Previously discharged with DX cellulitis LUE.	COPD, GERD, Arrhythmia, Peripheral Neuropathy 1/4/08-records received- Allergy to PCNs. PMH: DJD, moderte COPD, CAD, CHF, paroxysmal atrial fibrillation, GERD, HLP.			1						1	Cellulitis; Pneumonia	FLU3~SANOFI PASTEUR~U2488AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0958F~2~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0295564	11/05/2007	OR	5.0	5		F	10/29/2007	Sleepiness									Y	10/26/2007	10/26/2007	0	None	PVT	PVT		None	None - NKDA			1						1	Somnolence	DTAP~SANOFI PASTEUR~C2657AA~5~IM~LA~DTAP (DAPTACEL)~1|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B133BA~6~IM~RA~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2512AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~0986U~1~SC~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0295565	11/05/2007	KS	58.0	58		F	10/30/2007	Friday red streak across arm horizontally 3 in length 10/26/07 Friday excessive sleep nauseated/vomiting  10/26/07 fine on 10/27/07									Y	10/24/2007	10/26/2007	2	None	PUB	PVT	None	None	None			1						1	Erythema; Hypersomnia; Nausea; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA038AA~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0295567	11/05/2007	OH	1.8	1	.8	M	10/29/2007	Patient was given FluMist nasal spray today at age 21 mos. (Vaccine is recommended starting at 24 mos.)									Y	10/29/2007			None	PUB	PUB	None	None	None			1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500488P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0295568	11/05/2007	MO	32.0	32		F	10/26/2007	Dx: urticaria 2 hr flu shot-pt had maculopapular rash on body with pruritus-Doctor visit 10/25/07 Decadron 0.5 mL/2 mg				Y					U	10/23/2007	10/24/2007	1		PUB	PVT	Omega 3 + vitamin	None				1						1	Pruritus; Rash maculo-papular; Urticaria	FLU3~SANOFI PASTEUR~U2466AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295569	11/05/2007	MI	9.0	9		F	10/29/2007	No adverse reactions occurred. Pt was given a Hepatitis B vaccine by accident, pt was to receive a Hepatitis A.									Y	10/18/2007			None	PUB	UNK		None	RAD			1						1	Wrong drug administered	FLU3~SANOFI PASTEUR~U2498AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB319AA~4~IM~LA~HEP B (ENGERIX-B)~1|HPV4~MERCK & CO. INC.~1208F~1~IM~RA~HPV (GARDASIL)~1|VARCEL~MERCK & CO. INC.~1121U~2~IM~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0295571	11/05/2007	TX	4.0	4		F	10/26/2007	Adverse - none noted at time of incident. The above patient was given her siblings HAV In addition to the ordered flu vaccine. No reaction noted at the time of administration									Y	10/26/2007				PVT	PVT	No routine	None	Long nevus sole (L) foot			1						1	Wrong drug administered	FLU3~SANOFI PASTEUR~U2440~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0797U~3~IM~LL~HEP A (VAQTA)~1	USA		Influenza
0295572	11/05/2007	TN	7.0	7		F	10/24/2007	Lt. upper arm red, hot and indurated 8x6.5 cm on 10-18-07 14.5 x 11 cm on 10-19-07 Rx: Augmentin 1 1/2 tsp BID x 10 d; Tylenol with QOD prn. Redness and pain started decreasing 10-19-07 p.m.				Y					Y	10/17/2007	10/17/2007	0		PVT	PVT	Zyrtec one tsp qd	None	Asthma			1						1	Erythema; Induration; Pain; Skin warm	FLU3~SANOFI PASTEUR~U2510AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295573	11/05/2007	WI	62.0			M	11/02/2007	(R) red area 10 cm slightly tender (Patient received Pneumovax 1 yr ago dose)									Y					PVT	UNK						1						1	Erythema; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81108~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0555U~2~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295574	11/05/2007	NY	42.0	42		F	11/05/2007	Fainted within 3 minutes of Flu shot. Vomited 4 times approx. 30 minutes after Flu shot. and vomited 4 times approximately 2 hours after shot.				Y					Y	11/02/2007	11/02/2007	0	Blood Test - everything ok	PUB	PVT	Birth control pills	None	None			1						1	Blood test normal; Syncope; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80060~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0295576	11/05/2007	MI	50.0	50		F	10/18/2007	Vaccine administered during the day, by evening (before bed) felt sick to his stomach, had a fever of 101.2 during the night, felt better by afternoon of the following day, tx with Tylenol.									Y	10/09/2007	10/09/2007	0		PVT	UNK		None	Insulin dependent diabetes mellitus			1						1	Pyrexia; Stomach discomfort	FLU3~SANOFI PASTEUR~U2439AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295577	11/05/2007	IN	1.7	1	.7	F	10/27/2007	rash started on Trunk first then spread to extremities and face									Y	10/27/2007	10/27/2007	0	None	PVT	PVT		None	No			1						1	Rash	FLU3~SANOFI PASTEUR~U2504AA~3~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295580	11/05/2007	GA	73.0	73		M	10/24/2007	Received a flu shot on 10/10/07. Got flu on 10/16-17/07. Had no major exposure to persons with flu. Believe it resulted from the shot. Have not had flu in past 25 years. had shot each year.									Y	10/10/2007	10/16/2007	6		OTH	OTH	Hectrol; Zocor; Bernicar	None	None			1						1	Influenza	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0295585	11/05/2007	OH	46.0	46		F	10/29/2007	Lips, tingling, hot - lasting about 24 hours.									Y	10/26/2007	10/26/2007	0		PUB	PVT	Celexa	No	Allergic to Demeral			1						1	Paraesthesia oral; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79241~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295586	11/05/2007	SC	65.0	65		F	10/28/2007	Redness, itching and fever in arm where Td shot was given. Put on antibiotic, Prednisone and Zyrtec. Took 6 days to get better but still have some redness as of today 10-25-07.				Y					Y	10/04/2007	10/11/2007	7		UNK	UNK	Aciphex, Lipitor, Xonaphen inhaler, Vitamin B6, B12, Corio, Calcium					1						1	Injection site erythema; Injection site pruritus; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0295587	11/05/2007	CO	63.0	63		F	10/26/2007	Right arm - became very inflamed - swollen - site of injection to elbow. Very tender - hot to the touch - about 36 hours. No breathing problems - no heart palpations. Took diphenhydramine 25mg. PCP notified but not seen.									Y	10/23/2007	10/24/2007	1	N/A	OTH	OTH	Premarin, Provera, Diclofenac	N/A	Thyroid - Hypertension, Arthritis			1						1	Injection site inflammation; Injection site swelling; Skin warm; Tenderness	FLU3~SANOFI PASTEUR~U2509AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295588	11/05/2007	WY	8.0	8		F	10/26/2007	About 24 hours after receiving flu vaccine in (L) arm, the (L) arm became very red, swollen, tender, tight and itchy 19 cm x 27.5 cm extending to just above elbow. Pt was instructed to use scheduled Motrin, Benadryl, and ice packs. Also treated with short course of Prednisone.				Y					Y	10/23/2007	10/24/2007	1	None	MIL	MIL	Singulair, Albuterol	None	Asthma, Allergies	Full body hives, ? cellulitis per mom~Influenza (Seasonal) (no brand name)~UN~3.00~In Patient		1						1	Erythema; Oedema peripheral; Pruritus; Skin tightness; Tenderness	FLU3~SANOFI PASTEUR~U2501AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295590	11/05/2007	TX	45.0	45		F	10/27/2007	On September 29, 2007 at about 10:00 p.m. Patient, started having difficulty in breathing, a rapid heart beat, a dry cough and a lot of wheezing especially at night (wheezing). This continued until October 13, 2007 about 2 weeks. Since then and up to today October 22, 2007, I still feel a little wheezing and difficulty in breathing is now less than before.				Y					N	09/19/2007	09/29/2007	10	see attached copies	OTH	OTH	METFORMIN 500mg; GLIPIZIDE 10mg	None	Diabetes			1						1	Cough; Dyspnoea; Heart rate increased; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79238~2~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0295592	11/05/2007	WI	83.0	83		M	10/29/2007	C/O Lame shoulder (10-10 for 4 days) then muscle (for 5 days) then 6-8 black and blue mark where flu shot was given; was noted on the 15th of October. As of 10-30-07 arm still sore but much better.				Y					Y	10/09/2007	10/10/2007	1	None	PUB	PVT		None	None			1						1	Injection site bruising; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80684~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0295593	11/05/2007	OR	5.0	5		F	10/31/2007	report from-mother local reaction and swelling/redness took child to Emerg Room, D/T clinic closed already- Tx: Ice pack.				Y					Y	10/26/2007	10/26/2007	0		PUB	PUB	None	None	None			1						1	Erythema; Local reaction; Swelling	DTAP~SANOFI PASTEUR~C2607AA~UNK~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~02512AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295598	11/05/2007	CT	1.01	1	.0	F	10/30/2007	10/29/2007 Small area erythema at site (about 1.5cm).				Y						10/19/2007	10/29/2007	10		OTH	UNK		None	None			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~UT2474FA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0223U~3~UN~LL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0289U~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B54007H~4~UN~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0295601	11/05/2007	NY	0.6	0	.6	M	10/31/2007	Crying, fever, increased crying with movement of legs no redness. Localized reaction to Imm.				Y					Y	10/29/2007	10/29/2007	0		PVT	UNK		None	None			1						1	Crying; Local reaction; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B127AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2474AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0257U~3~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08700C~UNK~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0295602	11/05/2007	NY	5.0	5		M	10/23/2007	Localized reaction-red area on skin and painful				Y					Y	10/22/2007	10/23/2007	1	None	PVT	PVT		None				1						1	Erythema; Local reaction; Pain	FLU3~SANOFI PASTEUR~U2450AA~4~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0838U~2~SC~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0295603	11/05/2007	HI	60.0	60		F	10/26/2007	Site of injection: left deltoid Patient c/o mild muscle ache for two days, injection site sore/painful/ uncomfortable' tight and heavy; left side of neck down to left arm also tight and heavy. No treatment.									Y	10/23/2007	10/24/2007	1	None	PUB	PUB	Multivitamins; Calcium	None	None	~Influenza (Seasonal) (no brand name)~UN~0.00~In Patient	HI0701	1						1	Injection site pain; Injection site reaction; Myalgia; Sensation of heaviness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA2820A~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0295604	11/05/2007	GA	28.0	28		M	10/11/2007	Edema (L) arm. Pt c/o soreness (L) arm presently.									U	10/10/2007	10/10/2007	0		PUB	PUB		None	None		GA07066	1						1	Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80435~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0601F~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295605	11/05/2007	GA	53.0	53		F	10/11/2007	1) Sensitive to touch, per pt 2) pt c/o extreme soreness (R) arm 3) Edema noted (R) arm.									U	10/10/2007	10/10/2007	0		PUB	PUB		Sarcoidosis	Sarcoidosis Dx 5/1980		GA07067	1						1	Hyperaesthesia; Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80435~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0601F~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295606	11/05/2007	GA	68.0	68		M	10/15/2007	10/10/07 - Received Flu and Pneumonia vaccine in L arm on 10/11/07 - 11 A - Client reported feeling bad, tired. (L) arm swollen, tender and red - per client. Advil taken. 10/15/07 Client feeling better - (L) arm swelling decreased.									Y	10/10/2007	10/11/2007	1		PUB	PVT		None	None		GA07064	1						1	Erythema; Fatigue; Feeling abnormal; Oedema peripheral; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80957~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0601F~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295613	11/05/2007	IL	4.0	4		M	11/01/2007	Child with history of asthma. Became short of breath with cough and wheeze. Also red rash to face and neck.				Y					Y	10/31/2007	10/31/2007	0	N/A	PVT	PUB	None	URI	Asthma			1						1	Cough; Dyspnoea; Erythema; Rash; Wheezing	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14349AA~5~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2437AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0170~4~SC~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1217F~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0450F~2~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0295614	11/05/2007	FL	33.0	33		F	10/24/2007	Patient reports redness and soreness at site of injection about 8pm. Next day, she experienced myalgias and noticed increased swelling and redness (R) arm. decreased fever, chills, decreased appetite										10/22/2007	10/22/2007	0		UNK	UNK	Heparin	No	Factor V Leiden Deficiency Hypothyroid			1						1	Chills; Decreased appetite; Injection site erythema; Injection site pain; Injection site swelling; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~U249MA~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1005F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295615	11/05/2007	IL	33.0	33		F	10/30/2007	10/23 A.M. received vaccine - felt pain with injection, felt immediately pain after injection and continued to get worse through day. Unable to sleep due to pain - 10/30 - continue to c/o ache to injection area, radiates to shoulder.									U	10/23/2007	10/23/2007	0		OTH	PUB	Birth control	No	No			1						1	Injection site pain; Musculoskeletal pain; Pain; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~U2478AA~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0295616	11/05/2007	IL	68.0	68		F	11/05/2007	Received vaccine Oct 9th states. Approx 5 days later started with few pimple like hives that itch-continue to spread at present are on leg, groin-took Benadryl with No Relief									U	10/09/2007	10/14/2007	5		OTH	PUB	Actonel, HCTZ Atenolol	No	Hypertension			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2458EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295617	11/05/2007	GA	63.0	63		M	10/25/2007	Redness, warmth, and swelling at injection site with red streak to Axilla. Patient was seen by his primary care doctor who prescribed Dicloxacillin									U	10/23/2007	10/24/2007	1	None	OTH	PVT		No	Diabetes			1						1	Injection site erythema; Injection site streaking; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA302AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0964U~2~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295619	11/05/2007	CT	6.0	6		F	10/31/2007	4-5 vesicular lesions (L) arm.									Y	10/26/2007	10/30/2007	4		PVT	PVT		None	None			1						1	Rash vesicular; Skin lesion	FLU3~SANOFI PASTEUR~U2526AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0939P~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0295620	11/05/2007	TX	3.0	3		F	11/05/2007	Within 5-10 minutes after receiving the vaccine, the patient developed facial hives with some itching. Some facial flushing with 1-2 target lesions on the back.									Y	10/22/2007	10/22/2007	0	None	PVT	PVT	No	None	No			1						1	Flushing; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2528AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295621	11/05/2007	TN	48.0	48		F	10/30/2007	Lump developed under right arm in lymph node. Hot flashes followed by periods of chills. Dr told her if it didn't go away a couple of days to come back and she would take antibiotic.									U	10/25/2007	10/26/2007	1		OTH	PVT		None	Seasonal allergies			1						1	Chills; Hot flush; Lymphadenopathy	FLU3~SANOFI PASTEUR~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295623	11/05/2007	MD	44.0	44		M	11/05/2007	Pt reported to health unit this Am 11/5/07, reported severe itching to injection site day of injection 10/29/07, site had spot band aid applied post removal on 10/31/07, site became red and raised then skin rash spread all over body, hives and irreg pattern rash to bilat armpits/groin area severely itchy, denied any resp sxs, Rx Aveeno baths, instructed to see PMD today for eval/tx'mt.				Y					N	10/29/2007	10/29/2007	0	None	PUB	OTH	None	None	N/A			1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Rash generalised; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78994~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0295624	11/05/2007	MT	36.0	36		F	10/16/2007	10/15/07 following flu vaccine pt felt flushed, warm had some flushing on chest and neck 10/16/07 States she still feels some flushing-this is not noticeable. Has 4cm localized warm, mildly erythemic area at injection site.									Y	10/15/2007	10/15/2007	0	None	PUB	PVT						1						1	Flushing; Injection site erythema; Injection site warmth; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79721~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295625	11/05/2007	OH	18.0	18		F	11/05/2007	I gave the Gardasil in the Lt arm, immediately she was c/o pain and itching, swelling and redness occurred, ice applied and Benadryl given per MD.									Y	11/05/2007	11/05/2007	0		PVT	PVT	Advair; Albuterol PRN	N/A	Allergy Amoxicillin (2 rashes as infant - tried again in 1997 and ok after), asthma			1						1	Erythema; Pain; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U2527AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~12094~1~UN~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2416AA~1~UN~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2720AA~1~UN~RA~TDAP (ADACEL)~1	USA		Influenza
0295626	11/05/2007	SC	56.0	56		M	11/05/2007	c/o pain at site 2 weeks our from injection.									Y	10/17/2007	10/20/2007	3	None	OTH	UNK	Motrin prn	None	Gluten allergy			1						1	Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78481~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295627	11/05/2007	NY	45.0	45		F	11/05/2007	Flu shot administered 10/29/07 at 10 a.m. by 4 p.m., site of injection (left deltoid) became painful. Pain progressively worsened limiting R.O.M. and radiating to front and back of shoulder. Pain persists 7 days after injection.									N	10/29/2007	10/29/2007	0		OTH	UNK	ALLEGRA - seasonal allergies; ZIAC - for hypertension	None	Seasonal allergies and hypertension			1						1	Injected limb mobility decreased; Injection site pain	FLU3~SANOFI PASTEUR~U2458KA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295628	11/05/2007	SC	37.0	37		F	11/05/2007	10/19/07 received Flu shot in left hip. Woke up 10/20/07 with painful swelling in hands and all joints below neck. Progressively worsened, could not bend knees or ankles. Saw physician Monday 10/22/07. Labs drawn. Referred to Rheumatologist conts. with Sporadic stiffness and pain				Y					N	10/19/2007	10/20/2007	1		PUB	OTH	Unknown	None	None known			1						1	Joint swelling; Musculoskeletal stiffness; Oedema peripheral; Pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79719~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0295630	11/05/2007	WA	1.3	1	.3	F	11/05/2007	Decreased activity and restlessness 10/30/07. Seen 11/1/07 in ER see enclosed note				Y					U	10/29/2007	10/29/2007	0		PVT	PUB	None	None				1						1	Decreased activity; Restlessness	DTAP~SANOFI PASTEUR~C2607AA~4~UN~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2458BA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB181AA~1~UN~LL~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0295631	11/05/2007	GA	57.0	57		F	10/12/2007	Had immunization on 10-10-07 - noted redness, tenderness, and warm to touch on 10-11-07 - area around 2 long by 1 wide - adv cool compresses and Tylenol as needed to call MD is worse - left upperarm									U	10/10/2007	10/11/2007	1		PUB	UNK	Antidepressant daily; Estace - 2mgm/ 4mg; Donovan daily needed	None	Allergic to iodine take allergy shots		GA07065	1						1	Cold compress therapy; Injection site erythema; Injection site pain; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80957~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0601F~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295732	11/05/2007	NC	14.0	14		F	10/30/2007	Syncope 24 hours after administration of Gardasil and Flu vaccine.				Y					Y	10/18/2007	10/19/2007	1	None	PVT	UNK		None	None			1						1	Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80684~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HPV4~MERCK & CO. INC.~1061U~1~IM~RA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0299008	11/05/2007	AL	45.0	45		F	10/31/2007	This case was reported by a healthcare professional and described the occurrence of anaphylaxis in a 45-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline).  Concurrent medical conditions included hypertension.  Concurrent medications included Benicar.  On 3 October 2007 at 09:30 the subject received unspecified dose of Flulaval at 0.5 ml, intramuscularly in the left arm.  On 3 October 2007, five minutes after vaccination with Flulaval, the subject experienced anaphylaxis.  The healthcare professional considered the event was clinically significant (or requiring intervention).  At the time of reporting the outcome of the event was unspecified.  Follow-up received on 22 October 2007 via the healthcare professional.  She reported that the events resolved on 13 October 2007.  The healthcare professional considered that the events were serious and life-threatening.  The subject was hospitalized.  Diagnostic testing revealed normal results for cardiac enzymes, complete blood count, metabolic profile and electrocardiogram. The healthcare professional considered that the events were not related to medical history of concurrent illness, lack of efficacy, erroneous administration or suspected transmission of an infectious agent via a medicinal product.  The healthcare professional considered that the events were related to the use of Flulaval.			Y		Y	0			Y	10/03/2007	10/03/2007	0	CBC, 03Oct2007, normal; Cardiac enzymes, 03Oct2007, normal; Electrocardiogram, 03Oct2007, normal; Metabolic function test, 03Oct2007, normal	PVT	PVT	olmesartan medoxomil; frusemide	HYPERTENSION	HYPERCHOLESTEROLEMIA; Subject drinks wine occasionally and does not use tobacco.  The subject had not experienced any adverse events following previous vaccinations.		A0686757A	1						1	Anaphylactic reaction; Cardiac enzymes normal; Electrocardiogram normal; Full blood count normal; Metabolic function test normal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLAA043AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening,Hospitalisation	Influenza
0299009	11/05/2007	FL	52.0	52		F	10/31/2007	This case was reported by a healthcare professional and described the occurrence of a medication error in a 52-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline).  On 28 August 2007 at 15:00 the subject received 1st dose of Flulaval at 0.5 ml in the right arm.  On 28 August 2007, immediately following vaccination with Flulaval, it was noted that the vaccine given was from the past flu season (2006-2007).  This was considered to be a medication error.  The subject also developed injection site redness and swelling on 28 August 2007.  At the time of reporting the medication error was unresolved.  In the reporter's opinion, the events were probably related to treatment with Flulaval.									N	08/28/2007	08/28/2007	0	UNK	PVT	PVT		Unknown	The subject has previously received flu shots with no reactions.		A0678487A	1						1	Expired drug administered; Injection site erythema; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601011~1~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0299010	11/05/2007	ID				U	10/31/2007	This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline).  In September 2007 the subject received unspecified dose of Flulaval at 0.5 ml.  Subjects received doses of Flulaval from 25 September 2007 to 27 September 2007 in either the right or left arm.  This subject developed redness, itching and warmth to the touch at the injection site on a date 25 September 2007 to 27 September 2007.  At the time of reporting the events were resolved.  Six subjects experienced these events.  The physician recommended that the subjects take Tylenol and use cold compresses.									Y				UNK	PUB	PVT		Unknown			A0685450A	1						1	Injection site erythema; Injection site pruritus; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA043AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0299011	11/05/2007	ID				U	10/31/2007	This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline).  In September 2007 the subject received unspecified dose of Flulaval at 0.5 ml.  Subjects received doses of Flulaval from 25 September 2007 to 27 September 2007 in either the right or left arm.  This subject developed redness, itching and warmth to the touch at the injection site on a date 25 September 2007 to 27 September 2007.  At the time of reporting the events were resolved.  Six subjects experienced these events.  The physician recommended that the subjects take Tylenol and use cold compresses.									Y				UNK	PUB	PVT		Unknown			A0685457A	1						1	Injection site erythema; Injection site pruritus; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA043AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0299012	11/05/2007	ID				U	10/31/2007	This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline).  In September 2007 the subject received unspecified dose of Flulaval at 0.5 ml.  Subjects received doses of Flulaval from 25 September 2007 to 27 September 2007 in either the right or left arm.  This subject developed redness, itching and warmth to the touch at the injection site on a date 25 September 2007 to 27 September 2007.  At the time of reporting the events were resolved.  Six subjects experienced these events.  The physician recommended that the subjects take Tylenol and use cold compresses.									Y				UNK	PUB	PVT		Unknown			A0685458A	1						1	Injection site erythema; Injection site pruritus; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA043AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0299013	11/05/2007	ID				U	10/31/2007	This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline).  In September 2007 the subject received unspecified dose of Flulaval at 0.5 ml.  Subjects received doses of Flulaval from 25 September 2007 to 27 September 2007 in either the right or left arm.  This subject developed redness, itching and warmth to the touch at the injection site on a date 25 September 2007 to 27 September 2007.  At the time of reporting the events were resolved.  Six subjects experienced these events.  The physician recommended that the subjects take Tylenol and use cold compresses.									Y				UNK	PUB	PVT		Unknown			A0685459A	1						1	Injection site erythema; Injection site pruritus; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA043AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0299014	11/05/2007	ID				U	10/31/2007	This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline).  In September 2007 the subject received unspecified dose of Flulaval at 0.5 ml.  Subjects received doses of Flulaval from 25 September 2007 to 27 September 2007 in either the right or left arm.  This subject developed redness, itching and warmth to the touch at the injection site on a date 25 September 2007 to 27 September 2007.  At the time of reporting the events were resolved.  Six subjects experienced these events.  The physician recommended that the subjects take Tylenol and use cold compresses.									Y				UNK	PUB	PVT		Unknown			A0685460A	1						1	Injection site erythema; Injection site pruritus; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA043AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0299015	11/05/2007	ID				U	10/31/2007	This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline).  In September 2007 the subject received unspecified dose of Flulaval at 0.5 ml.  Subjects received doses of Flulaval from 25 September 2007 to 27 September 2007 in either the right or left arm.  This subject developed redness, itching and warmth to the touch at the injection site on a date 25 September 2007 to 27 September 2007.  At the time of reporting the events were resolved.  Six subjects experienced these events.  The physician recommended that the subjects take Tylenol and use cold compresses.									Y				UNK	PUB	PVT		Unknown			A0685461A	1						1	Injection site erythema; Injection site pruritus; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA043AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0299016	11/05/2007	NY				U	10/31/2007	This case was reported by a healthcare professional and described the occurrence of injection site rash in a few elderly subjects of unspecified gender, all greater than 65-years-old, who were vaccinated with Flulaval (GlaxoSmithKline).  In September 2007, the subjects received the first doses of Flulaval (.5 ml, unknown, administered in either the right or left arm).  The reporter indicated that the vaccines were administered with 5/8 inch needles (it was noted that the Center for Disease Control recommends 1 to 1.5 inch needles to prevent seepage into tissues).  At an unspecified time after vaccination with Flulaval, the subjects experienced rashes around the injection sites and/or injection site burning.  Those subject who contacted the medical office were instructed to apply cold compresses to the affected areas; the three or four subjects had not re-contacted the medical office at the time of this report.  At the time of reporting the events were resolved.				Y					Y				UNK	PVT	PVT		Unknown	The subjects' medical history, concurrent medical conditions, and/or concomitant medications were unspecified.  The subjects had not previously received influenza vaccinations.		A0686008A	1						1	Injection site irritation; Injection site rash; Wrong technique in drug usage process	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA035AA~1~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0299017	11/05/2007	NY	86.0			F	10/31/2007	This case was reported by a healthcare professional and described the occurrence of influenza-like symptoms in an 86-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline).  In September 2007 the subject received the first dose of Flulaval (.5 ml, unknown, unknown arm).  At an unspecified time after vaccination with Flulaval, the subject experienced influenza-like symptoms and cough.  At the time of reporting the events were unresolved.				Y					N				UNK	PVT	PVT		Unknown	The subject's medical history, concurrent medical conditions, and/or concomitant medications were unspecified.  The subject had not previously received influenza vaccination.		A0686009A	1						1	Cough; Influenza like illness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA035AA~1~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0299018	11/05/2007					U	10/31/2007	This case was reported by a healthcare resourced management company and described the occurrence of welts at injection sites in an unspecified number of subjects of unspecified ages and genders who was vaccinated with Flulaval (GlaxoSmithKline).  On unspecified dates the subjects received unspecified dose(s) of Flulaval (unknown).  At an unspecified time after vaccination with Flulaval, all of the subjects vaccinated at an unspecified healthcare provider's location experienced welts at the injection sites.  Each subject's welt was about two inches across and looks very similar to a bug bite.  At the time of reporting the outcome of the events was unspecified.									U				UNK	OTH	OTH		Unknown			A0686329A	1						1	Injection site reaction; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0299019	11/05/2007	TN				F	10/31/2007	This case was reported by a healthcare professional and described the occurrence of injection site redness in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline).  On an unspecified date in 2007 (between 18 September 2007 and 02 October 20007), the subject received unspecified dose of Flulaval (0.5 ml, unknown, left arm).  On the same date as vaccination with Flulaval, the subject experienced injection site redness, injection site pruritus, and swelling injection site.  Medical attention was required at the doctor's office.  The events were resolved on the same of vaccination/ onset of the adverse events.  The healthcare professional considered the events were probably related to vaccination with Flulaval.  The nurse reported a total of four subjects who experienced similar reactions following administrations of Flulaval between 18 September 2007 and the time of reporting on 02 October 2007 (please see GSK reference numbers A0686378A, A0686379A, and A0686380A).  Some of the subjects experienced swelling at the site of injection to about softball size.  The subjects had previously received influenza vaccinations and had not experienced adverse reactions other than one patient who may have experienced redness at injection site.				Y					Y				UNK	PVT	PVT		Unknown	The subject's concomitant medications were unspecified.  The subject had no known medical history determined to be relevant to immunization.		A0686373A	1						1	Injection site erythema; Injection site pruritus; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA033AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0299020	11/05/2007	TN				F	10/31/2007	This case was reported by a healthcare professional and described the occurrence of injection site redness in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline).  On an unspecified date in 2007 (between 18 September 2007 and 02 October 20007), the subject received unspecified dose of Flulaval (0.5 ml, unknown, left arm).  On the same date as vaccination with Flulaval, the subject experienced injection site redness, injection site pruritus, and swelling injection site.  Medical attention was required at the doctor's office.  The events were resolved on the same day of vaccination/ onset of the adverse events.  The healthcare professional considered the events were probably related to vaccination with Flulaval.  The nurse reported a total of four subjects who experienced similar reactions following administrations of Flulaval between 18 September 2007 and the time of reporting on 02 October 2007 (please see GSK reference numbers A0686373A, A0686379A, and A0686380A).  Some of the subjects experienced swelling at the site of injection to about softball size.  The subjects had previously received influenza vaccinations and had not experienced adverse reactions other than one patient who may have experienced redness at injection site.				Y					Y				UNK	PVT	PVT		Unknown	The subject's concomitant medications were unspecified.  The subject had no known medical history determined to be relevant to immunization.		A0686378A	1						1	Injection site erythema; Injection site pruritus; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA033AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0299021	11/05/2007	TN				F	10/31/2007	This case was reported by a healthcare professional and described the occurrence of injection site redness in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline).  On an unspecified date in 2007 (between 18 September 2007 and 02 October 20007), the subject received unspecified dose of Flulaval (0.5 ml, unknown, left arm).  On the same date as vaccination with Flulaval, the subject experienced injection site redness, injection site pruritus, and swelling injection site.  Medical attention was required at the doctor's office.  The events were resolved on the same day of vaccination/ onset of the adverse events.  The healthcare professional considered the events were probably related to vaccination with Flulaval.  The nurse reported a total of four subjects who experienced similar reactions following administrations of Flulaval between 18 September 2007 and the time of reporting on 02 October 2007 (please see GSK reference numbers A0686373A, A0686378A, and A0686380A).  Some of the subjects experienced swelling at the site of injection to about softball size.  The subjects had previously received influenza vaccinations and had not experienced adverse reactions other than one patient who may have experienced redness at injection site.				Y					Y				UNK	PVT	PVT		Unknown	The subject's concomitant medications were unspecified.  The subject had no known medical history determined to be relevant to immunization.		A0686379A	1						1	Injection site erythema; Injection site pruritus; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA033AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0299022	11/05/2007	TN				U	10/31/2007	This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline).  On an unspecified date in 2007 (between 18 September 2007 and 02 October 20007), the subject received unspecified dose of Flulaval (0.5 ml, unknown, left arm).  On the same date as vaccination with Flulaval, the subject experienced injection site redness, injection site pruritus, and swelling injection site.  Medical attention was required at the doctor's office.  The events were resolved on the same day of vaccination/ onset of the adverse events.  The healthcare professional considered the events were probably related to vaccination with Flulaval.  The nurse reported a total of four subjects who experienced similar reactions following administrations of Flulaval between 18 September 2007 and the time of reporting on 02 October 2007 (please see GSK reference numbers A0686373A, A0686378A, and A0686379A).  Some of the subjects experienced swelling at the site of injection to about softball size.  The subjects had previously received influenza vaccinations and had not experienced adverse reactions other than one patient who may have experienced redness at injection site.				Y					Y				UNK	PVT	PVT		Unknown	The subject's concomitant medications were unspecified.  The subject had no known medical history determined to be relevant to immunization.		A0686380A	1						1	Injection site erythema; Injection site pruritus; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA033AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0299023	11/05/2007	NV				F	10/31/2007	This case was reported by a healthcare professional (also the subject) and described the occurrence of sore arm (injection site) in an adult female subject who was vaccinated with Flulaval (GlaxoSmithKline).  Concurrent medical conditions included back pain and high blood pressure.  Concurrent medications included Diovan, Ultram and naproxen.  In 2006 the subject inadvertently received a dose of Flulaval at 1.0 ml.  This was considered to be an accidental asymptomatic overdose.  Flulaval is indicated for use at a dose of 0.5 ml.  No adverse events were reported.  On 3 October 2007, the subject again inadvertently received a dose of Flulaval at 1.0 ml (dose given with one-half inch needle).  This was considered a medication error.  Immediately after vaccination with Flulaval, the subject developed a sore arm at the injection site.  This too was considered to be an accidental asymptomatic overdose.  The subject should have received a 0.5 ml dose of Flulaval.  At the time of reporting the outcome of the sore arm at injection site was unresolved and in the reporter's opinion, the event was possibly related to treatment with Flulaval.									N	10/03/2007	10/03/2007	0	UNK	PVT	PVT	valsartan; tramadol hydrochloride; naproxen	BACK PAIN, HIGH BLOOD PRESSURE	The subject has previously received flu shots.  No reactions were documented.		A0686475A	1						1	Accidental overdose; Immediate post-injection reaction; Incorrect dose administered; Injection site pain; Vaccine positive rechallenge	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA052AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0299024	11/05/2007	OH				U	10/31/2007	This case was reported by a healthcare professional and described the occurrence of injection site pruritus in eight to ten adult subjects of unspecified gender who were vaccinated with Flulaval (GlaxoSmithKline).  Concurrent vaccination included pneumonia vaccine, (manufacturer unspecified) given between 28 September 2007 and 04 October 2007.  Between 28 September 207 and 04 October 2007 the subjects received unspecified doses of Flulaval (0.5 mL, unknown).  Right away following vaccination with Flulaval, the subjects developed itching at the injection sites.  At an unspecified time after receiving Flulaval, the subjects also experienced events including hard knots at the injection sites, injection site redness and injection site pain.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.  The healthcare professional stated that eight to ten subjects of the approximately fifty who were administered Flulaval between 28 September 2007 and 04 October 2007 reported side effects.  The healthcare professional also indicated that most symptoms have resolved but unsure exactly how many; however, an outcome of unresolved was also reported.									N				UNK	PVT	PVT		Unknown	The subjects' medical histories, concomitant medical conditions, and concomitant medications were not specified.		A0686721A	1						1	Immediate post-injection reaction; Injection site erythema; Injection site induration; Injection site pain; Injection site pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA034AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0299025	11/05/2007	AL				U	10/31/2007	This case was reported by a healthcare professional and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of Flulaval (unknown).  After vaccination with Flulaval, the subject experienced injection site reaction and burning sensation injection site.  At the time of reporting the outcome of the events was unspecified.  The healthcare professional considered the injection site reaction possibly related to vaccination with Flulaval.  The reporter believed that there may have been a problem with the particular lot of vaccine used.									U				UNK	PVT	OTH		Unknown			A0687740A	1						1	Injection site irritation; Injection site reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA043AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0295665	11/06/2007	GA	1.25	1	.3	F	11/06/2007	Lt thigh swollen and bruise looking warm to touch  and very red									Y	11/05/2007	11/05/2007	0		PVT	PUB	N?A	No	No			1						1	Contusion; Erythema; Oedema peripheral; Skin warm	DTAP~SANOFI PASTEUR~U2156BA~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~Ut2473GA~2~ID~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0074U~3~IM~RL~HIB (PEDVAXHIB)~1|MMRV~MERCK & CO. INC.~0284U~1~SC~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0295667	11/06/2007	MN	65.0	65		M	11/06/2007	Pt called on 11/6/07 to report reaction, he says he got sob and wheezy right after the vaccine. He used albuterol inhaler. He continues to have sore throat ,hoarseness, dizziness and weakness, and diarrhea one week later.										10/30/2007	10/30/2007	0		PVT	UNK		no	nkda, hx of asthma			1						1	Asthenia; Diarrhoea; Dizziness; Dysphonia; Dyspnoea; Pharyngolaryngeal pain; Wheezing	FLU3~SANOFI PASTEUR~u2502aa~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295670	11/06/2007	WI	51.0	51		F	11/06/2007	got flu vaccine with thimersol had 3 inch hive develop below injection site heat redness swelling of deltoid worse evening of 11/05/2007										11/05/2007	11/05/2007	0		PVT	UNK	claritin,doepin nasalcort,albuterol	none	allergys			1						1	Injection site erythema; Injection site swelling; Injection site urticaria; Injection site warmth	FLU3~SANOFI PASTEUR~u2599aa~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295671	11/06/2007	OH	0.58	0	.6	F	11/06/2007	Seizure - Brief 6 days after administration of vaccines									N	10/23/2007	10/29/2007	6	none	PVT	PVT	Phenobarbitol	none	Possible seizure disorder	seizure~DTaP (Daptacel)~2~0.30~In Patient		1						1	Convulsion	FLU3~SANOFI PASTEUR~U2445AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B54007D~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0295673	11/06/2007	TX	48.0	48		F	11/06/2007	ON 10/16/07 DEVELOPED PAIN GOING DOWN NECK HEADACHE-- NOT RELEASED BY TYLENOL OR MOTRIN-PROGRESS TO SINUS AND CHEST CONGESTION- STARTED LEVQUIN ON 10/18/07-FOR 6 DAYS DIDN'T IMPROVE- FOLLOW UP WITH NP STARTED ON FACTIVE- DEVELOPED ON 10/22/07 LT ARM AND L LEG PAIN/NUMBNESS-REPORTED 11/2/07				Y					Y	10/15/2007	10/16/2007	1	NONE	PUB	UNK		NONE POSSIBLE SINUS PROBLEMS				1						1	Headache; Hypoaesthesia; Neck pain; Pain in extremity; Respiratory tract congestion; Sinus congestion	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA315BA~6~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0295674	11/06/2007	NY	80.0	80		F	11/06/2007	Diffuse erythemia and tactile warmth to Left upper arm				Y					Y	11/01/2007	11/02/2007	1		PVT	UNK		No	No			1						1	Erythema; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA319BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0743F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0295675	11/06/2007	TX	4.0	2	.5	M	11/06/2007	Splotchy rash on legs and arms,erythema to vaccination site 15 min after vaccination was administerd. Benedryl 18.75 mg po, Orapred ODT 15mg was given stat.  Reaction had improve after 45min. Will repeate Orapred ODT 15mg for 4 days									Y	11/05/2007	11/05/2007	0		PVT	PVT		Resolve Pneumonia				1						1	Injection site erythema; Rash macular	FLU3~SANOFI PASTEUR~U2508AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295680	11/06/2007	WY	25.0			M	11/05/2007	Information has been received from a PharmD concerning a 25-26 year old male whose vaccination history was unknown was vaccinated (route and site not reported) on 23-OCT-2007 with Pneumovax 23. On the same day the patient was concomitantly vaccinated with DTAP (manufacturer unknown) and influenza virus vaccine (unspecified - manufacturer unknown). On 24-OCT-2007, the patient developed influenza-like symptoms: headache, chills, fever and body aches which resulted in the patient missing two days of work. The patient sought unspecified medical attention and no further information is available. At the time of this report the patient had not recovered. The pharmacist felt that the patient's headache, chills, fever and body aches were disabling. This is one of several reports from the same source. Additional information has been requested.				Y				Y	N	10/23/2007	10/24/2007	1	Unknown	OTH	OTH	Unknown		Unknown		WAES0710USA05790	1						1	Chills; Headache; Inappropriate schedule of drug administration; Influenza like illness; Pain; Pyrexia	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0295696	11/06/2007		35.0			F	11/06/2007	This case was reported by a healthcare professional and described the occurrence of decreased blood pressure in a 35-year-old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. The subject's medical history included celiac sprue and gluten intolerance. The reporter was not aware of any reactions experienced by previous influenza vaccinations other than this reported event. On an unspecified date in 2005 the subject received unspecified dose of Influenza virus vaccine (unknown). In 2005, less than one year after vaccination with Influenza virus vaccine, the subject experienced decreased blood pressure, vomiting, cough, passed out and blood count changes. The healthcare professional reported on 30 October 2007, that the events occurred 2 years ago. The subject reported to the healthcare professional that the reaction was similar to those reactions she developed following exposure to Gluten. The subject was seen in an emergency room. At the time of reporting the events were resolved. Comment: Passed out was assessed as medically serious by GSK.				Y					Y	01/01/2005	01/01/2005	0	UNK	OTH	OTH		Unknown	CELIAC SPRUE, GLUTEN INTOLERANCE		A0691776A	1						1	Blood count abnormal; Blood pressure decreased; Cough; Loss of consciousness; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0295697	11/06/2007		30.0	30		M	10/12/2007	24 hours after receiving FluMist patient noticed dark brown urine. Next day CK level found elevated. Did have afebrile URI symptoms starting 2 days prior to receiving FluMist. Received IV fluid therapy for 48 hours after 24 hrs of oral therapy until CK < 5000. No other complications.  11/27/2007 MR received DOS 10/13-16/2007.  Pt reported dark brown urine 1 day following Flumist vax.  Pt had 5 day hx of afebrile URI prior to receiving vaccine.  PE (+) for pharyngeal erythema and nasal discharge. Diffuse aches noted in arms and back.  DX:  Rhabdomyolysis (likely due to viral illness, possibly Flumist). TXd with IVF.  Normal urine color noted 10/16/2007. Resolution of Lab abnormalities noted on 10/16 as well.				Y	Y	2			Y	10/12/2007	10/12/2007	0	Creatine kinase > 5,000. Labs and Diagnostics:  CT scan pelvis (-).  UA (+) for large blood, 2+ protein, small bili, 1+ urobil, CK>5000.  K+ 5.5.	MIL	MIL	None	URI x 2; no fever	NKDA; No meds. PMH: Gastroenteritis.  BP elevated.  midback pain.  knee pain.  Patellofemoral syndrome L.  Esophagitis chronic reflus.  Allergic to pollens. Recent URI.			1						1	Blood creatine phosphokinase increased; Chromaturia	FLUN3~MEDIMMUNE VACCINES, INC.~500485P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0295701	11/06/2007	CA	74.0			M	11/06/2007	Patient reported complaints of chest irritation, cough, runny nose and headache within few hours of receipt of flu shot.									Y	11/01/2007			none	PUB	PUB	Naprosyn	none reported	unknown			1						1	Chest discomfort; Cough; Headache; Rhinorrhoea	FLU3~SANOFI PASTEUR~U2512AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295702	11/06/2007	MD	26.0	26		F	11/06/2007	Received flumist on 3 Oct 07, on 5 Oct developed soreness in pad of right thumb (thenar surface). This became much more sore by 2 wks after flumist.  Was seen by provider and given Motrin (didn't help), was seen again one wk later and was given tramadol (didn't help either). Today 6 Nov, hand is still sore.  Is being worked up now by different provider.				Y					U	10/03/2007	10/05/2007	2	CBC, ESR, CRP, CMP	MIL	MIL	Depo provera	No	Allergic to percocet.  Gyn problems	No~ ()~NULL~~In Patient|No~ ()~NULL~~In Sibling1		1						1	C-reactive protein; Full blood count; Metabolic function test; Pain in extremity; Red blood cell sedimentation rate	FLUN3~MEDIMMUNE VACCINES, INC.~500485P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0295703	11/06/2007	GA	39.0	39		F	11/05/2007	PATIENT STATES INJECTION DID NOT FEEL RIGHT FROM THE TIME IT WAS GIVEN. ACUTE ONSET OF PAIN @ 1PM BY EVENING WAS HAVING BACK SPASMS & BACK PAIN. COULD NOT LIFT LEFT ARM, PATIENT CALLED NFP NEXT DAY & INSTRUCTED TO CALL PRIMARY CARE PHYSICIAN. SEEN BY PCP 11/2/07 DX WITH INFLAMED ROTATOR CUFF, GIVEN IBUPROPHEN 800MG TID, ICE BID,& REFERRED TO PT. UNABLE TO GO @ PRESENT DOING HOME EXERCISES PER PCP'S INSTRUCTIONS.				Y					U	10/22/2007	10/22/2007	0		PVT	PVT						1						1	Back pain; Immediate post-injection reaction; Injected limb mobility decreased; Muscle spasms; Pain; Rotator cuff syndrome	FLU3~SANOFI PASTEUR~U2506AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295707	11/06/2007	NY	44.0	45		F	11/06/2007	she recieved flu shot in left deltoid at 3:30 pm. about 1 1/2 hours later, she developed itching upper left arm, shoulder, left lateral neck to her hairline. No rash or swelling. This subsided about two hours later. In the morning, the itch returned and spread to her lateral hips. She applied caladryl with some relief. comlained of having trouble taking a deep breath, but no shortness of breath. Given atarax 25 mg po q6-8 hours prn. Advised not to recieve flu vaccine									Y	11/06/2007	11/06/2007	0		PUB	PVT	lexapro, xanax, levsin	none	allergy to bananas, kiwi, bactrim			1						1	Dyspnoea; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80070~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295708	11/06/2007	NY	38.0	38		F	11/06/2007	burning hives on back of neck...was not sure if resulted from vaccination but did not notice the rash before.									U	11/06/2007	11/06/2007	0	none	UNK	PVT	Effexor XR 150 mg	nonw	allergies to morphine, seasonal allergies, some scent allergies			1						1	Burning sensation; Rash; Urticaria	FLU3~SANOFI PASTEUR~42507aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295711	11/06/2007	MI	52.0	52		F	11/06/2007	Received Fluzone 10-23-07, left  deltoid, as part of employee Flu vaccination campaign.  On 11-1-07 presented in office to see CFNP for worsening pain on her left side, left upper back and shoulder. Patient was taking ibuprofen 400-600mg qhs, extra strength Tylenol 2 pills bid and Bengay patches without benefit. Left trapezious tenderness, with mildly redulced flexion, normal extension, normal lateral motion, normal rotation, normal stabiltiy, strength, and tone.  There was minimal edema of the left trapezius area.  The was left rib tenderness. She experienced left deltoid tenderness, with full range of motion, normal stabiltiy, strength, and tone. Bicep reflexes were symmetrical, skin temp was symetrical with no discoloration.  CFNP ordered Naprosyn 500mg, one BID and Prednisone dose pack.  By 11-6-07 the patient reported feeling 100% better. She experienced severe pain and tenderness which did not improve until she was placed on the the Medrol dose pack.									Y	10/23/2007	10/24/2007	1	None	UNK	UNK	Albuteral, Proventil, Lisinopril	None	Aspirin, Biaxin, IV dye, Prilosec,   Asthma, MVP, Type II Diabetes, Hypertension	none~ ()~~0.00~In Patient		1						1	Back pain; Musculoskeletal pain; Myalgia; Pain; Tenderness	FLU3~SANOFI PASTEUR~U2436AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295712	11/06/2007	MI	1.58	1	.6	M	11/06/2007	patient was given 0.5ml instead of 0.25ml is twice the dose for age. no adverse effect at this time.									U	11/06/2007	11/06/2007	0		PVT	PUB		left otitis media				1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~U2437AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295713	11/06/2007	WA	39.0	39		M	11/06/2007	Pt complained fo itching and hives 20 minutes after receiving influenza vaccine.  Pt was given Diphenhydramine 50mg po, 40min later pt had wheeezing, tingling in throat with some SOB and mild edema of tongue noted.  Pt was given 125mg IV methylprednisolone and trasported to E.D.  Pt kept over night and given a prednisone taper.				Y					Y	10/30/2007	10/30/2007	0		PUB	PUB			Asthma			1						1	Dyspnoea; Pruritus; Throat irritation; Tongue oedema; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U2498AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295714	11/06/2007	WA	19.0	19		F	11/06/2007	Client states 1-2 hours after receiving immunizations she experienced headache, stomach ache, chills, dizziness, fatigue, felt pins and needles all over and her face was flushed.  These symptoms continued all night.  Client states she called her physician who instructed her to take 75 mg diphenhydramine.  On 11/2/07, client stated she continued to experience dizziness, nausea and fatigue.  On 11/5/07 client stated her symptoms had resolved, but on 11/4/07 she had one episode of unknown duration of dizziness, blurred vision and nausea.									Y	11/01/2007	11/01/2007	0	None.	PUB	PVT	None.	None.	None.			1						1	Abdominal pain upper; Chills; Dizziness; Fatigue; Flushing; Headache; Nausea; Paraesthesia; Vision blurred	FLU3~SANOFI PASTEUR~u2512aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~c2758aa~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0295715	11/06/2007	MI	22.0	22		F	11/06/2007	19cm Red Swollen area on Left Arm , fever >101.1 Arthus reaction from Tdap vaccination				Y					U	10/26/2007	10/27/2007	1		PVT	PVT	Hydrocodone/Acetaminophen, Rozerm, Restoril, Buspirone,Xopenex HFA, Allegra, Promethazine,Ortho-Novum, Ranitidine ,Keppra, Drysol,hydroxyzine, Imodium	none	Liver Transplant for Cancer, Kidney Stones, Chronic pain,			1						1	Oedema peripheral; Pyrexia; Type III immune complex mediated reaction	FLU3~SANOFI PASTEUR~U2500AA~UNK~ID~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1063U~1~ID~LL~HPV (GARDASIL)~1|PPV~MERCK & CO. INC.~0880F~1~ID~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2862AA~1~ID~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0295717	11/06/2007	SD	3.0	3		F	11/06/2007	THIS CHILD RECEIVED 0.25 ML OF FLU VACCINE INSTEAD OF 0.5 ML OF FLU VACCINE.									Y	10/26/2007				PUB	PUB		NONE	NONE			1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~UT2460CA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295718	11/06/2007	SD	3.0	3		F	11/06/2007	THIS CHILD RECEIVED 0.25 ML OF FLU VACCINE INSTEAD OF 0.5 ML OF FLU VACCINE FOR THE FIRST DOSE OF A TWO DOSE SERIES.									Y	10/25/2007				PUB	PUB		NONE	NONE			1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~UT2460CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295721	11/06/2007	CA	73.0	73		M	11/06/2007	Patient received Pneumococcal vaccine in right deltoid on 11/05/07 in the afternoon.  Patient informed wife on 11/06/07 that his inner right arm was swollen painful in the afternoon.  I spoke with wife at 3:20 PM on 11/06/07.  She stated that patient stated he had inner right arm swelling to his inner elbow.  The swelling was causing him pain.  Wife stated that patient does not normally complain of pain so to her this means that it was really painful.  I inquired if the patient has any other symptoms such as swollen tongue, difficulty breathing, rash, bumps, hives, other pain -  Wife stated NO, he does not have anything else, no hives, just the swelling in the inner arm.  She was calling from the pharmacy counter at pharmacy so I told her that because patient had drug interactions with the treatment regime that I wanted to discuss my recommendation with patient's doctor prior to providing a recommendation.  I recommend a cold (ice) compress until I could contact Dr.  Dr. was out of the country so I contacted his other physician Dr.  Dr and I discussed and came up with the following treatment plan: Benadryl 25mg 1 po q 6 h, Tylenol 500mg 1 po q 6 h prn, and Ice compresses prn.  I then contacted wife with the treatment regime.  She stated patient was using the cold compress and she would begin Tylenol and Benadryl as soon as she purchased at pharmacy.  She asked if treament was urgent and I informed her that she needed to get the Tylenol to help his pain and the Benadryl would bring down the swellling and reaction.  She said she would go to pharmacy and pick up the medication. I then telephoned pharmacy and had the pharmacist document this intervention in the computer and located the medication for the patient.									U	11/05/2007	11/06/2007	1	N/A	UNK	UNK	Flomax, Dilantin, Furosemide, Lomotil, Trileptal, Vytorin	None	CVD			1						1	Cold compress therapy; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2509AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0886F~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295723	11/06/2007	CA	35.0	35		M	11/06/2007	Onset of flu-like symptoms about 26 hrs after vaccination (Thursday, 12 PM). By 32 hrs after vaccination (6 PM), severe body aches, headache, malaise, nausea, sweating, dizziness, loss of appetite. Took H2O and ibuprofin at 34 hr after vaccination (8 PM), which began to give relief from most symptoms within 90 min. Able to get some sleep. Symptoms returned about 6 AM (Friday), less severe, but still significant. Took ibuprofin again at 7 AM. Symptoms again returned at about 5 PM. Took ibuprofin again at 7 PM. Experienced intestinal distress with diarrhea throughout night. Lower level of symptoms througout following day (Saturday). Took ibuprofin 2 more times. Fatigue remained for 2 more days (Sunday & Monday). Back to 100% 6 days after vaccination (Tuesday, 11/06/2007).									Y	10/31/2007	11/01/2007	1	None.	UNK	PVT	Gemfibrozil (Lopid), Vytorin, Uniretic, Fluoxetine, Ritalin LA	None.	Adult Attention-Deficit Disorder, Hyperlipidemia, Hypertension			1						1	Anorexia; Diarrhoea; Dizziness; Fatigue; Headache; Hyperhidrosis; Influenza like illness; Intestinal functional disorder; Malaise; Nausea; Pain	FLU3~SANOFI PASTEUR~U2492AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295726	11/06/2007	CA	58.0	58		F	10/31/2007	The next morning it was (left upper arm) red and swollen about 8 band around the arm, hot to the touch, very sore and painful, this condition lasted 4-5 days. No systemic symptoms.									Y	10/25/2007	10/26/2007	1	None	PVT	PVT	Armour Thyroid	None	Allergy to sulfa			1						1	Erythema; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2454AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295729	11/06/2007	NY	71.0	71		F	11/01/2007	vaccine given one day 10/30/07. Redness and swelling, pain same day. That night fevers 101-102; lasting 2 days. Seen by MD - observation.									Y	10/30/2007	10/30/2007	0		PVT	PVT		None	None			1						1	Erythema; Pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U2500AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0200U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295730	11/06/2007	TX	48.0	48		M	11/01/2007	Injection site started to bleed, and then began to swelling immediately. Injection site knotted up. Patient was held for monitoring. Approximately 5 min. after injection patient had complaints of nausea and hot sweats. 25mg IM Benadryl was administered and ice applied to injection site. Patient began to feel better and left approx. 45 min. after injection.									Y	11/01/2007	11/01/2007	0		OTH	PVT	None	N/A	Seasonal allergies			1						1	Hyperhidrosis; Injection site haemorrhage; Injection site swelling; Nausea	FLU3~SANOFI PASTEUR~U2514AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295731	11/06/2007	VA	20.0	20		F	11/01/2007	Pat developed fever 102, localised swelling at site of injection 24 hrs after injection she was Rx 1st w Benadryl but when she developed fever she was given Zosyn IV and discharge on Clindamycin 1300 mg qid x 10d				Y					Y	10/18/2007	10/19/2007	1	CBC I don't have the data	OTH	OTH			History of Pneumonia			1						1	Full blood count; Injection site swelling; Pyrexia	FLU3~SANOFI PASTEUR~U2448AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~9722106~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0295733	11/06/2007	OH	27.0	27		F	10/31/2007	Sensation in arm immediately after injection. Approximately 2 1/2 hours after receiving influenza vaccination developed throat burning, wheezing, eyes itching and excessive tearing with mucous production in eyes and throat. Developed fever and swollen glands in the evening. Took Benadryl 50 mg po. Took Nyquil 10/31/07 Continues with some eye and throat increased mucous.									Y	10/30/2007	10/30/2007	0		PUB	PUB	Allergy shots and OCPs	slight migraine sx in am	Bee sting allergy			1						1	Eye pruritus; Injection site reaction; Lacrimation increased; Lymphadenopathy; Pyrexia; Throat irritation; Wheezing	FLU3~SANOFI PASTEUR~U278CA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295734	11/06/2007	OH	30.0	30		F	10/26/2007	Patient stated that shortly after she received the flu shot she became nauseated and had diarrhea. She then had pain in her back and trouble breathing. She called the health district and was told to get to emergency. She received an IV in the ER for nausea and was told that it was a reaction to the flu shot. Temp unknown				Y					Y	10/26/2007	10/26/2007	0		PUB	PUB						1						1	Back pain; Diarrhoea; Dyspnoea; Nausea	FLU3~SANOFI PASTEUR~U2465AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295735	11/06/2007	VA	30.0			F	10/29/2007	Approximately 1 hr after injection developed redness and itching from site to elbow. 25mg Benadryl taken by client. An hour later reported bark like coughing and was advised to see MD or go to ER. 3hr later, reported to ER for wheezing and breathing issues received IV Prednisone and Benadryl and doing fine following Tx.				Y					Y	10/24/2007	10/24/2007	0		UNK	UNK						1						1	Cough; Dyspnoea; Injection site erythema; Injection site pruritus; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80060~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0295736	11/06/2007	IA	53.0	53		F	10/25/2007	Pneumococcal vaccine Rt Arm-3pm injection area sore and swelling becoming severe lasting 2 days. 6:30pm-8:30pm 10/23) severe chills and shivering. 12:30am (10/24) Fever >101 Benadry and ASA taken 3:30 am coughing and chest tightness abt 10 mins. 10am (10/24) itching and blotchy 4 inch radius of injection site. Benadryl and ASA q4-6 hrs thru out ana cont taking 10/25 Pain and swelling only low grade temp.									Y	10/23/2007	10/23/2007	0		PVT	PVT	Premarin, Detrol LA, Elmiron Zetia, Chantix	None	LI SCI, chronic bronchitis, Rheumatic fever, Erythromycin			1						1	Chest discomfort; Chills; Cough; Injection site pain; Injection site pruritus; Injection site swelling; Pyrexia; Rash macular	FLU3~SANOFI PASTEUR~U2438AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0486U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295737	11/06/2007	MS	9.0	9		M		Rec'd Flu Vac yesterday. Pt states injection site became sore and red approx 4-5 hrs after inj. This am entire (R) deltoid and below was red and warm. Pt alert and swelled up approx 1100 today. Approx 1330 today mom called, pt vomiting. Told, to go to hosp.									U	10/29/2007	10/29/2007	0	None	PVT	UNK	Adderall XR .10m	None	ADHD-Taking Adderall XR			1						1	Injection site erythema; Injection site pain; Skin warm; Vomiting	FLU3~SANOFI PASTEUR~UT2460EA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295739	11/06/2007	MI	69.0	69		F	10/30/2007	Rt arm Reddened and swollen to elbow after Pneumonia Vac. Rocephin 1gm IM given and Rx Bactrim DS once BID #20									Y	10/22/2007	10/22/2007	0	None	PVT	PVT		Low back pain				1						1	Injection site erythema; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~0554u~1~SC~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~05546~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295740	11/06/2007	MS	10.0	10		F	10/26/2007	Mother called to report arm where flu shot was given red and tender to touch and hot to touch Pt seen by M.D.-Advil, Benadryl and warm compress				Y					Y	10/25/2007	10/26/2007	1		PVT	PVT			None			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U2466AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295741	11/06/2007	OH	1.2	1	.2	M	10/31/2007	Febrile seizure associated with rash and fever 9 days after vaccine									Y	10/16/2007	10/25/2007	9		PVT	PUB	None	None	None			1						1	Febrile convulsion; Pyrexia; Rash	FLU3~SANOFI PASTEUR~UT2160AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF108AA~4~IM~LL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~1027F~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0674U~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0295742	11/06/2007	MI	55.0	55		F	10/30/2007	patchy redness swelling and warmth near Pneumovax injection site. no fever Treated with Clarinex and Zanax									U	10/24/2007	10/25/2007	1		PVT	PVT	Lipitor, Tenormin, Lexapro, Dyazid, Glucosamine, Calcium MVI, Darvocet, Desyrel	None	mild renal insufficiency, HTN			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80432~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~05544~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295744	11/06/2007	IN	4.0	4		F	10/30/2007	Large, red, swollen local reaction. Seen in ER 10-27-07. Treated with Bactrim and Keflex for cellulitis. Seen by doctor in my office 10-29-07 and received Bactrim and Omnicef. Still swollen. Added Benadryl today.				Y					U	10/26/2007	10/27/2007	1		PVT	PVT	None	None	None			1						1	Erythema; Local reaction; Swelling	FLU3~SANOFI PASTEUR~U2486AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295745	11/06/2007	WA	44.0	44		F	10/30/2007	Fever, chills, hives, redness, swelling at (L) deltoid/upper arm				Y					Y	10/26/2007	10/27/2007	1	None	PVT	PVT	Norvasc; Toprol XL	None	Allergy to sulfa, Cozaar, Lisinopril; HTN, Hyperlipidemia, increased LFT's			1						1	Chills; Erythema; Oedema peripheral; Pyrexia; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA043AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|TDAP~SANOFI PASTEUR~C2825AA~1~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0295746	11/06/2007	TX	1.7	1	.7	F	10/31/2007	Sleeping all day, fussy this AM, not eating this AM, immunizations administered yesterday.									U	10/30/2007	10/31/2007	1	Strep screen negative; sent out throat cx	PVT	UNK		None	None			1						1	Culture throat; Diet refusal; Irritability; Somnolence; Streptococcal identification test negative	FLU3~SANOFI PASTEUR~UT2460EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1470F~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1358U~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0295748	11/06/2007	MI	65.0	65		F	10/27/2007	Hives, feverish, chest heaviness, shortness of breath within 24 hours. Taken to ER - rec'd IV Benadryl, Decadron, Duoneb - admitted for observation.  8/26/08 Reviewed hospital medical records of 10/26-10/27/2007. FINAL DX: allergic reaction to pneumovax Records reveal patient experienced chest tightness & discomfort, SOB, flu-like symptoms of achy, tired, hives in left axilla & scratchy throat.  Admitted for observation & to r/o MI which was r/o.				Y	Y	2			Y	10/25/2007	10/26/2007	1	BMP, heme 1  LABS: WBC 12.3(H).  Troponin I neg.  Chemistry essentially WNL.	OTH	PVT		(L) eye macula - nearly resolved	PMH: Recent conjunctivitis.  Obesity.  Reactive airway disease.  Allergic: chocolate & hummus.			1						1	Chest discomfort; Dyspnoea; Haematology test; Metabolic function test; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U2466AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1035F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0295749	11/06/2007	NM	60.0	60		F		Got up to to go work 10/24/07 and felt extremely nauseated and felt like I was going to faint. Laid down for 20 min, lightheadedness left, nausea, chills, fever up to 101 for the next 48 hours with lightheadedness on moving but never felt as if I was going to faint again. Also experienced achiness - general for 3 days after injections.									Y	10/23/2007	10/24/2007	1		OTH	PUB		None	Ileostomy since 1986, Hypertension - controlled with meds			1						1	Chills; Dizziness; Nausea; Pain; Pyrexia; Syncope	FLU3~SANOFI PASTEUR~O2488AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0962U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295750	11/06/2007	IL	1.0	1	.0	M	10/26/2007	Broke out in rash yesterday - rash all over body - no itching or apparent discomfort at this time. Gave Benadryl Elixir 4oz/IRF 1/2 tsp PO q 6 hrs prn (generalized erythematous maculo-papular rash)									Y	10/15/2007	10/25/2007	10	None	PVT	PUB	10/15/07 started on Orapred 15/5 1 tsp OD x 4 days; Amoxil 400/5 1 tsp BID x 10 days; Albuterol inhalation solution	Bronchitis and ROM	N/A			1						1	Rash erythematous; Rash generalised; Rash maculo-papular	FLU3~SANOFI PASTEUR~UT2460EA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAV13182AA~1~IM~RL~HEP A (HAVRIX)~1|MMRV~MERCK & CO. INC.~0612u~1~SC~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0295751	11/06/2007	FL	23.0	23		F	10/26/2007	Cramping, Diarrhea, Chills				Y					Y	10/25/2007	10/26/2007	1		PVT	PVT	None		None			1						1	Abdominal pain; Chills; Diarrhoea	FLUX~UNKNOWN MANUFACTURER~AFLLA030AA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0295752	11/06/2007	MD	43.0	43		F	11/02/2007	Complete body aches and chills 14 hours after receiving flu shot on 10-15-07.									Y	10/15/2007	10/16/2007	1		PUB	OTH	Elavil	N/A				1						1	Chills; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0295753	11/06/2007	MO	71.0	71		M	10/28/2007	Redness, blotchiness around injection site (R) deltoid) and (R) axilla. Temp 98.2.									U	10/26/2007	10/27/2007	1	N/A	PVT	PVT	Plavix, Crestor, ASA, Xanax	None				1						1	Injection site erythema; Rash macular	FLU3~SANOFI PASTEUR~U2515AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0963U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295754	11/06/2007	AK	15.0	15		F	10/29/2007	Mother of patient, call the clinic to report her daughter, pt after receiving the flu vaccine and the HPV #1 on 10/26/07 around 9:00am. 48hr later developed a fever of 103.6. Is treating the fever with Tylenol. Fever remains at 103 today this a.m.									U	10/26/2007	10/28/2007	2		PUB	PUB	None	None	None			1						1	Pyrexia	FLU3~SANOFI PASTEUR~UT435AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1424E~1~IM~RA~HPV (GARDASIL)~1	USA		Influenza
0295755	11/06/2007	IN	1.5	1	.5	M	10/22/2007	Pt was given #4 DTaP and Influenza on 10-17-07. Mom called on 10-18-07 stating pt had a temp with max temp of 102.0. Mom also stated he had an episode of body twitching and he was staring into space; has done this in the past.									Y	10/17/2007	10/18/2007	1		PVT	PVT			GERD			1						1	Body temperature increased; Muscle twitching; Staring	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B056BA~4~UN~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2456AA~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295756	11/06/2007	KY	77.0	77		F	10/26/2007	Evening after receiving Flu Shot she began having Tingling of skin, itching, rash over arms-legs, and torso, and nausea.									Y	10/19/2007	10/19/2007	0		PVT	PVT	Hydrocodone, Medrol 32mg	None	Sulfa, Allergic Rhinitis, Back Pain, headaches			1						1	Nausea; Paraesthesia; Pruritus; Rash	FLU3~SANOFI PASTEUR~U2497AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295758	11/06/2007	TX	10.0	10		F	10/30/2007	seizure episode									Y	10/26/2007	10/27/2007	1	EEG	PVT	PVT		None	None			1						1	Convulsion; Electroencephalogram	FLU3~SANOFI PASTEUR~U24499AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295760	11/06/2007	IL	72.0	72		F	10/26/2007	Patient received influenza and pneumonia vaccines around 10:30am on 10/25/07. At about 5:30pm, the right arm which had the pneumonia vaccine swelled up and was red and warm to the touch. The patient also developed a fever of 101 deg and took 600 mg of Motrin. After 4 hours, the fever went away and the swelling went down but the arm was still swollen and red.									N	10/25/2007	10/25/2007	0		OTH	PUB	Mobic 7.5 mg					1						1	Injection site erythema; Injection site swelling; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U252844~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295762	11/06/2007	CA	3.0	3		M	10/30/2007	3 yo boy with 4-5d fever, began soon after receiving influenza shot, no rash, fever now resolving - no h/o problems with flu shot prior to that.									Y	10/25/2007	10/26/2007	1	None	MIL	MIL	None	None	None			1						1	Pyrexia	FLU3~SANOFI PASTEUR~U2516AA~5~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295763	11/06/2007	NJ	7.0	7		M	10/30/2007	vaccines administered on 10/19/07, seen on 10/22/07 with muscle aches and fever. Quick strep and throat culture (-), mother states on 10/24/07 c/o severe calf pain and still has fever up to 103 deg, seen in office again on 10/25/07 with muscle pain and weakness and sent for bloodwork. ASO + Lyme were (-) but total CK 5554, diagnosed with acute benign myositis									Y	10/19/2007	10/22/2007	3	Quick Strep and throat culture (-), bloodwork, ASO + Lyme were (-) but total CK 5554	PVT	PVT	None	None	None			1						1	Asthenia; Blood creatine phosphokinase increased; Borrelia burgdorferi serology negative; Culture throat negative; Myalgia; Myositis; Pain in extremity; Pyrexia; Streptococcal identification test; Streptococcal identification test negative	FLUN3~MEDIMMUNE VACCINES, INC.~500487P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~1015U~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0295765	11/06/2007	NE	49.0	49		F	11/02/2007	Reports fever beginning 6 hrs after receiving injection. This lasts about 12 hrs.									Y	10/30/2007	10/30/2007	0	None	OTH	OTH	Unknown	None	Unknown			1						1	Pyrexia	FLU3~SANOFI PASTEUR~U2434AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295766	11/06/2007	NE	48.0	48		M	10/31/2007	HC reports fever and muscle aching 6-8 hours after vaccine given.									Y	10/30/2007	10/30/2007	0	None	OTH	OTH	Unknown	None known	None known			1						1	Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U2434AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295767	11/06/2007	NE	43.0	43		F	10/31/2007	Reports itching (R) upper arm and shoulder and fever but not temperature actually taken.									Y	10/30/2007	10/30/2007	0	none	OTH	OTH	Unknown	None	None known			1						1	Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~U2434AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295768	11/06/2007	NY	60.0	60		F	11/01/2007	Pt. given Pneumovax Lt. deltoid 10-30-07, 10-31-07 developed 4cm x 4cm induration Lt. deltoid, erythema, Lt anterior neck, total body rash, no fever									Y	10/30/2007	10/31/2007	1		PVT	PVT	Nexium, Actonel, Chantix					1						1	Erythema; Induration; Rash generalised	FLU3~SANOFI PASTEUR~U2500AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0038U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295769	11/06/2007	MN	72.0	72		F	11/01/2007	Erythema and induration over biceps area.				Y					U	10/29/2007	10/29/2007	0	None	PVT	OTH	Amitriptyline; Keflex; Dicyclomine; Premarin; Hydrochlorothiazide; Levothyroxine; Metoprolol; Prazosin; Prednisone; Verapamil CR;	None	Hypothyroidism, Hyperlipidemia, Ankylosing spondylitis, HTN			1						1	Erythema; Induration	FLU3~SANOFI PASTEUR~U2445AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295770	11/06/2007	MA	44.0	44		F	11/12/2007	Observed a rash on (L) arm heaviest at site of vaccination; slowly making down to wrist. Itchy if touched.									Y	10/24/2007	10/25/2007	1	Increased Rh factor (460) +; thyroid nodule	PVT	PVT	None	None	None			1						1	Injection site rash; Pruritus; Rheumatoid factor increased; Thyroid neoplasm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA029AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0295771	11/06/2007	LA	36.0	36		M	11/02/2007	10/31/07 some body aches, neck stiffness. 11/1/07 PM - fever, stiff neck, headache, 11/2/07 Temp 101.4l, stiff neck, headache.				Y						10/30/2007	10/31/2007	1	CBC normal; Rapid strep negative; Rapid flu negative	UNK	PVT	Glucovance, Zoloft, Benacor, Norvasc	No	Diabetes; Hypertension, Obesity			1						1	Body temperature increased; Full blood count; Headache; Musculoskeletal stiffness; Pain; Pyrexia; Streptococcal identification test	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA041AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0295772	11/06/2007	MA	49.0	49		F	10/31/2007	elevated body temperature 101 deg, chills, body aches, upset stomach 5 hours symptoms and temp down w/800 mg Motrin									Y	10/30/2007	10/30/2007	0		PUB	UNK						1						1	Body temperature increased; Chills; Pain; Stomach discomfort	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA050AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0295776	11/06/2007	ME	53.0	53		F	11/01/2007	Pt has had moderate muscle pain requiring treatment daily with acetaminophen at sight of injection for 10 days after injection									N	10/22/2007	10/23/2007	1	None	PVT	PVT	Synthroid, Lexapro, aspirin, Calcium, fish oil	None	hydrothyroidism, hydrocephalus with shunt placed			1						1	Injection site pain; Myalgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA067AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0295779	11/06/2007	OK	51.0	51		F	10/30/2007	10-17-07 1:00 pm 3 hr post injection swollen lymph nodes under arm (left). 3:00 pm Lymph nodes neck swelling 8:00 pm Lymphodes neck totally swollen 10-18-07 5:00 am neck, face swollen to eyes difficulty swallowing, spleen pain.									Y	10/17/2007	10/17/2007	0		PVT	UNK	Heprin;Trental 400 mg bid; Diovan HCT 160/12.5 mg daily; Boniva 150 mg	Total Vaginal Hysterectomy	Ultram; codeine + sulfa allergies; Vascular insufficiency; Hypertension			1						1	Abdominal pain; Dysphagia; Lymphadenopathy; Swelling face	FLUX~UNKNOWN MANUFACTURER~80823~5~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~05554~1~IM~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0295780	11/06/2007	NY	1.5	1	.5	F	11/01/2007	Post breakfast-got scolded-cried, R eye was red Then got lethargic, eyes half closed and almost fell over. Felt warm called 911-> Pediatric ER. Exam normal. ?Breath holding? just short of a febrile seizure ?stomach cramps (diarrhea on 10/29)				Y					Y	10/25/2007	10/27/2007	2	No lab work recent Hgb 13.7 on 10/11/07 (anemia is associated with breath holding)	PVT	PVT	None	None	None			1						1	Breath holding; Crying; Diarrhoea; Haemoglobin decreased; Lethargy; Ocular hyperaemia; Skin warm	DTAP~SANOFI PASTEUR~C2760AA~4~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~SPU2505AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1259U~2~UN~LL~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0295781	11/06/2007	CA	42.0	42		F	11/01/2007	Flu vaccine given 10/30/07 - for HCW. 11/1/07 reported reaction to shot. Injection site red 2 1/2 x 1 1/2 inches, swelling and tender area larger. Appears well otherwise. No other similar reactions.										10/30/2007	11/01/2007	2	N/A	PUB	UNK	Not known	None	None known			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2494AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295783	11/06/2007	SC	4.0	4		M	11/01/2007	redness, swelling, pain in (L) arm ?from flu shot on 10/30/07-rec. Zinacef 750mg IM 11/1/07 then started on Keflex 250 mg one tsp po tid x 10d- (see picture)										10/30/2007	10/31/2007	1	None	PVT	PVT	None	None	None			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2529AA~5~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295784	11/06/2007	MA	26.0	26		F	11/01/2007	Approx 4 hours post-vaccination, employee states eyes swelled shut, face swelled, experienced difficulty swallowing and breathing. Employee states that she took Benadryl, fell asleep, woke this morning with some residual swelling to eyes and face. Seen by her PCP and given antihistamine x 7 days.				Y					Y	10/31/2007	10/31/2007	0	None	OTH	PVT	Nicoderm patch	None - afebrile	None			1						1	Dysphagia; Dyspnoea; Eye swelling; Swelling face	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80684~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0295786	11/06/2007	WA	36.0	36		M	10/29/2007	Upon vaccination, client noted pain at the site and bruising shortly thereafter (R) Deltoid)). Sunday 10/28 at approx 900 AM, Client noted erythema and swelling of the injection site. This AM he noted increased pain and swelling of the entire (R) arm with pain of his joints (R shoulder, elbow and hand/fingers). Has not taken any meds. Denies any respiratory symptoms. He is out of town for work related business and plans to see PCP later today. 10/30/07 patient has not yet seen PCP but made TC & was told to take Benadryl 50mg @ HS. Took dose last night arm site better but cont swollen & painful.									Y	10/27/2007	10/28/2007	1		PUB	PUB	None	None	Client has heart anomaly - NPW		OR200746	1						1	Arthralgia; Injection site bruising; Injection site erythema; Injection site pain; Injection site swelling; Oedema peripheral	FLU3~SANOFI PASTEUR~2512AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295787	11/06/2007	OR	7.0	7		M	10/23/2007	Child c/o itching the next AM. Mom looked at the site and noted redness of approx slightly larger than a 50 cent piece with swelling noted at that time. Given 10 mg (1 1/2 tsp) Benadryl. By that afternoon the erythema and swelling had progressed down to elbow and was spreading to the underside of the arm. Given 2nd dose of Benadryl. Areas also flat to touch and was swollen with what appeared as one large contiguous hive. By Saturday AM 10/20/07, color fading, Sunday 10/21, no longer hot to touch, could see border on where red rash had been on Monday. Today appears as a bruise of smaller rxn.									Y	10/18/2007	10/19/2007	1		PUB	PVT	None	None	Child has history of reactive airway disease		OR200745	1						1	Injection site erythema; Injection site swelling; Pruritus; Rash	FLU3~SANOFI PASTEUR~U2499AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295788	11/06/2007	OR	77.0	77		F	10/26/2007	Two day post vaccine, pt developed hives on back of torso and back of neck. They lasted two weeks, then resolved. Pt has had flu vaccine in past without reaction. Denies allergy to eggs				Y					Y	10/05/2007	10/07/2007	2		PUB	PVT		None	None		OR200744	1						1	No reaction on previous exposure to drug; Urticaria	FLU3~SANOFI PASTEUR~U2443AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295789	11/06/2007	IN	5.0	5		F	11/01/2007	Patient developed red, indurated area at site of vaccine 6x10cm. She developed aches and temp 100. No other symptoms.									U	10/30/2007	10/31/2007	1		PVT	PVT		No	Asthma			1						1	Body temperature increased; Injection site erythema; Injection site induration; Pain	FLU3~SANOFI PASTEUR~U2486AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295791	11/06/2007	AZ	23.0	23		M	11/02/2007	None stated.									U	11/01/2007				PVT	PUB						1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1|TDAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~TDAP (NO BRAND NAME)~1	USA		Influenza
0295792	11/06/2007	AL	63.0	63		M		None stated				Y					N	10/04/2007	10/05/2007	1	clinical evaluation only by 3 sep	OTH	OTH	Nitroquic, Metoprolol, Requip, Diltiazem, Meloxicam, Lisinopril, Crestor, HCTZ, Pacerone, thyroid, Metformin	None	HTN, elevated lipid, NIDDM, Apnea, Hypothyroid, Arrhythmia, IHD			1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79282~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0295793	11/06/2007	OH	62.0	62		F	10/30/2007	Small knot reported by pt after the fact, unable to measure or examine.									Y	10/24/2007	10/24/2007	0		PVT	UNK		None	HTN - GERD - Increased Lipid - Hypothyroid			1						1	Skin nodule	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1035F~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295794	11/06/2007	MD	20.0	20		M	11/06/2007	1 1/2 hrs after receiving flu vaccine c/o body aches. After 4 hrs had 102 temp. By the next morning had headache and severe sore throat x 4d. Could not eat/drink x 4d - dehydration. Consulted with PMD day after vaccination.				Y					Y	10/29/2007	10/29/2007	0	None	PUB	OTH	None	None	None			1						1	Body temperature increased; Dehydration; Headache; Pain; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U2462AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295797	11/06/2007	RI	50.0	50		M	11/06/2007	Patient reports generalized body rash developed 2 hours after receiving Flu vaccine on 11/1/07. No medical attention seeked. No known reactions to previous vaccines. No known egg allergy has received Flu vaccine in the past									N	11/01/2007	11/01/2007	0	None	OTH	PUB	ATENOLOL, MAG 64	On treatment for vertigo	HTN			1						1	Rash generalised	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA026A~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0295798	11/06/2007	FL	66.0			F	10/30/2007	Patient c/o a reaction to an immunization. Patient had a Flu and Tetanus vaccine on 10-12-07. Patient had localized pt to right arm with erythema and mild edema. ROM is decreased secondary to pain with is some tingling in the right hand. Patient was given Vicodin for pain.									Y					PVT	OTH		Unknown	Unknown			1						1	Erythema; Joint range of motion decreased; Oedema peripheral; Pain in extremity; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~UN~UN~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0295800	11/06/2007	NY	1.5	1	.5	M	11/02/2007	Irritable, temp 104.6 rectal									Y	10/30/2007	11/01/2007	2		PVT	PUB						1						1	Body temperature increased; Irritability	FLU3~SANOFI PASTEUR~UT2475AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295801	11/06/2007	VA	36.0	36		F	11/05/2007	Patient had severe pain with TD and had tenderness on the right thigh									U	11/01/2007			None	PVT	PVT		None	None			1						1	Pain; Tenderness	FLU3~SANOFI PASTEUR~U2451AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~Td161~UNK~UN~UN~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0295802	11/06/2007	IA	56.0	56		F		Patient reports sore arm and chills began at approximately 7-8 pm. Convulsions began at 9pm and was taken by ambulance to hospital. CT head scan and blood work done.  Was released at approximately 1:30am and instructed not to receive Flu shot in the future.				Y					Y	11/01/2007	11/01/2007	0		OTH	OTH	VYRORIN, METAFORMIN	None	Codeine and sulfa allergies; high cholesterol; glucose intolerance			1						1	Blood test; Chills; Computerised tomogram; Convulsion; Pain in extremity; Blood test normal; Chills; Computerised tomogram normal; Convulsion; Pain in extremity	FLU3~SANOFI PASTEUR~U2511AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2511AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0295724	11/07/2007	NC	57.0	57		M	11/07/2007	Severe myalgias and arthralgias, fever (101.5) and diarrhea (brief and transient.  Myalgias and arthralgias were severe.  Orthostasis.  Onset of symptoms within a few hours of vaccine.  No local reaction at injection site.				Y					U	11/06/2007	11/06/2007	0	Labs - CBC, Sed Rate, CMP, CPK were all within normal limits.  Blood culture is pending.	UNK	UNK	Lipitor	None	Elevated cholesterol.			1						1	Arthralgia; Blood creatine phosphokinase normal; Blood culture; Diarrhoea; Dizziness postural; Full blood count normal; Metabolic function test normal; Myalgia; Pyrexia; Red blood cell sedimentation rate normal	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0295725	11/07/2007	SC	60.0	60		F	11/07/2007	Five days after admin. of Flu Vaccine, I very suddenly developed extreme joint pain in my knee (was nearly unable to walk up stairs), which lasted 3 days, and then disappeared over-night.  Pain then developed in my shoulder joint.  It continues, though it seems to be very gradually improving.  My grandson has had a very similar event:  He is 3 years old and developed over-night(two days after the vaccine injection)such extreme pain in his leg/knee joint that he could/would not walk on his leg.  He also had arm pain, though not as extreme.  Because this had happened to me, my daughter waited to take him to the pediatritian.  However, it did not resolve, and after six days, he did see the MD.  She evaluated/drew labs, etc, and stated their practice had seen two other children with the same events.  One who actually was hospitalized.  Once again...overnight the pain disappeared, however it has now moved to his other leg, though it is less severe.  His pediatritian stated she felt it was probably a reaction to the thimerosol in the vaccine, and that he should never have another flu shot.									N	10/04/2007	10/10/2007	6		PVT	PVT						1						1	Abasia; Arthralgia; Pain in extremity	FLU3~PFIZER\WYETH~?~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0295845	11/07/2007		25.0	25		F	11/06/2007	Information has been received from a registered nurse concerning a 25 year old female with drug reaction/allergy to amoxicillin/clavulanate potassium (AUGMENTIN) and codeine, and a history of tonsillectomy who on 23-OCT-2007 was vaccinated subcutaneously, back of right arm with the first 0.5 mL dose of Pneumovax 23, (Lot # 656233/0200U). Concomitantly, the patient was vaccinated into the opposite arm with influenza virus vaccine (unspecified). The nurse reported that the patient was hospitalized either late 24-OCT-2007 or early in the morning on 25-OCT-2007 because of cellulitis and infection on one of her arms. This was the patient's first dose of Pneumovax 23. The area was lanced and the patient was still in the hospital. The nurse did not know which arm was affected. The nurse requested a lot check for Pneumovax 23, (Lot # 656233/0200U). At the time of the report, it was unknown if the patient recovered. Additional information has been requested.				Y	Y	0	Y		U	10/23/2007	10/24/2007	1	Unknown	OTH	OTH		Drug hypersensitivity	Tonsillectomy		WAES0710USA05779	1						1	Cellulitis; Infection; Surgery	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0200U~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0295852	11/07/2007	IL	65.0	65		F	11/05/2007	Shaking, trembling,chills, high (102.4 degree) fever, whole body muscle aches.  My husband called our family physician emergency line. Dr. was on call and recommended Tylenol and fluids to relieve symptoms. I took 500 mg Tylenol every 4-6 hours and water throughout the night. Symptoms abated by morning but I had no appetite for the next 24 hours, and aches continued throughout the next day and night, ending after about 48 hours.  I don't ever remember feeling this sick in my life.  My blood sugars still require extra humalog to bring them down 5 days after vaccinations. I called the Department of Health for the information about vaccines that are required in this form and reported my symptoms.									Y	11/01/2007	11/01/2007	0		UNK	UNK	Humalog, Avapro 150, Fosamax 70	None	IDDM, controlled high blood pressure	never~ ()~~0.00~In Patient|never~ ()~~0.00~In Sibling		1						1	Anorexia; Blood glucose abnormal; Chills; Malaise; Myalgia; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U2489AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0675F~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295853	11/07/2007	NE	28.0	28		F	11/07/2007	Received Fluzone on 11/1/07.  That night started itching, and was scratching her skin.  On 11/2 she had hives and bumps all over.  On 11/3, her hands were swollen.  She saw here doctor who gave her a steroid injection, and placed her on steroids.				Y					U	11/01/2007	11/01/2007	0		PUB	PVT	Yasmin	no known illness	Allergic to Amoxicillan and Codeine			1						1	Oedema peripheral; Pruritus; Rash; Scratch; Urticaria	FLU3~SANOFI PASTEUR~U2464AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295854	11/07/2007	PA	6.0			M	11/07/2007	bicep where admin. got swollen to twice the size and very hard and hot.   from the flu vaccine appt was monday morning did not see any reaction til wednes. morning  I don't know what manufactor .									N					PVT	UNK	lamictal daily gave tylenol to treat	none				1						1	Induration; Oedema peripheral; Skin warm	FLUX~UNKNOWN MANUFACTURER~dont know info~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0295855	11/07/2007	NY	42.0	42		F	11/07/2007	difficulty breathing/wheezy;fast heart beat;chills;achy body;headache									Y	11/06/2007	11/06/2007	0		UNK	PVT	Advair; zyrtec; loestrin	none	mild asthma			1						1	Chills; Dyspnoea; Headache; Heart rate increased; Pain; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0295857	11/07/2007	TX	45.0	44		F	11/07/2007	10/17 Vaccine given in left deltoid.  Within hours the left arm from shoulder to fingertips were red and edemoutous.  Pt. c/o extreme itching and whelps visible.  Prednisone 20mg. PO given imediately.  Hydoxyzine 25mg. PO taken at bed time to relieve the itching.  10/18 Seen in the ER c/o increasing pain in arm and in joints from the hip to neck.  The left arm had increase in swelling.  Pt. took Tylenol, Ibuprofen and Excedrin to relieve pain with not results.  Medrol dose pack and Toradol given to pt. i				Y					Y	10/17/2007	10/17/2007	0		PUB	PVT	unknown	none	DEMEROL, VICODIN			1						1	Arthralgia; Erythema; Oedema; Oedema peripheral; Pain in extremity; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2452AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295859	11/07/2007	CO	59.0	59		M	11/07/2007	flu SHOT GIVEN 10/25/07  General feelig of malaze on Saturday and Sunday following.  Little inpact on activities.  Monday AM head ache, chills, able to complete workday.  Tuesday severe head ache, chills able to complete workday.  Tuesday night diarreha, vomiting (dry heaves).  Wednesday home in bed.  Severe head ache, chills, no further diarreha or vomiting.  Thursday temp 101.1 @ 5am (first taken)  stayed home in bed same symptoms. temp 100.8 @ 1pm. Reported sickness to company Nurse.  Friday more of the same, Missed work. temp over 100 all day.  Seen by primary care provider at military clinic.  Diagnosis: flu symptoms. Saturday and Sunday home continued head ache, chills, fever.  Monday (Nov 5)returned to work with head ache and chills all day. Went from 205 pounds to 195 pounds over course of the period.									Y	10/25/2007	10/27/2007	2	No tests conducted.  If symptoms not related to shot, the coincidence was perfectly timed.	UNK	PVT	zocor, glucosamine, Centrum vitamins	None known.	elevated cholesteral levels, no others			1						1	Chills; Diarrhoea; Headache; Influenza; Malaise; Pyrexia; Retching; Vomiting; Weight decreased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0295860	11/07/2007	MD	66.0	66		F	11/07/2007	Pt stated that the AM after receiving the flu vac, her arm was red, hot, swollen, and itching a little.  By the next AM, arm was less swollen and not as bright red.  Pt stated that she never had any discomfort at the site.  Nurse recommended that she apply an ice pack and take some Tylenol or Advil to reduce the redness and swelling further.										11/02/2007	11/03/2007	1	na	UNK	PVT	Pt did not return calls- unable to obtain further info.	did not return calls- unable to obtain info	unknown			1						1	Erythema; Oedema peripheral; Pruritus; Skin warm	FLU3~SANOFI PASTEUR~U2507AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295861	11/07/2007	CT	77.0	77		F	11/07/2007	Pt stated two hours after receiving the vaccine she had a sore arm and difficulty breathing. She went outside her home and administered her albuterol inhaler and felt better. Two hours later she again experienced the sore arm and the difficulty breathing she visited the drug store to get more albuterol which she took and again felt better. At approximately 7pm she experienced the same symtoms again and had a neighbor drive her to Hospital. At this time she was also experiencing a stiff neck. They administered a nebulizer treatment and kept her for observation until 11pm. She has not experienced any further difficulties. She reported the incident to our Agency on 11/5/07.  11/14/2007 MR received for ER visit 10/26/2007 with DX: Acute asthma exacerbation.  Pt presented to ER with moderate dyspnea.  Had 3 episodes of wheezing and sweating requiring albuterol. (+) muscle soreness at injection site. PE WNL. Given albuterol neb and d/c with epipen.			Y	Y					Y	10/26/2007	10/26/2007	0	Patient has a history of reactions to many environmental chemicals. She keeps epinephrine at home and has had to use it on occasions.	UNK	UNK	Vasotec, Levisin, Albuterol, Phenobarbitol.	None	Chronic Occupational Asthma. Allergies to many environmental chemicals. PMH:  Asthma.  Allergies: Corn, Mold, NSAIDS, Soy, Sulfa./			1						1	Dyspnoea; Musculoskeletal stiffness; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78476~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening	Influenza
0295862	11/07/2007	MA	31.0	31		F	11/07/2007	wheezing and tightness in chest, coughing (asthma-like symptoms) ~4 hours post-vax lasting 6 hours before sleep- no symptoms next AM; sore throat ~10hrs post-vax - no symptoms next AM; redness and irritation in both eyes ~6 hours post-vax lasting ~24hrs.  No treatment sought.									Y	11/06/2007	11/06/2007	0		UNK	UNK	none	none	seasonal asthma; sulfa allergy			1						1	Asthma; Chest discomfort; Cough; Erythema; Eye irritation; Ocular hyperaemia; Pharyngolaryngeal pain; Wheezing	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0295863	11/07/2007	MD	15.0	15		F	11/07/2007	Adult flu vaccine (fluarix) given to my daughter instead of child's flu vaccine (fluzone).										11/03/2007				PVT	PVT	Adderall XR					1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0295865	11/07/2007	TX	47.0	47		F	11/07/2007	11/05 - Influenza, live, intranasal vaccine (vaccine record date reflects 8 Nov 05) was administered while performing (weekend duty); 2-3 weeks later (week after Thanksgiving) developed sore throat; slight fever, stuffy head & other flu-like symptoms; 12/05- Sore throat continued, noticeable rash appeared on thighs & small lymph nodes on face; 1/06 - same symptoms continued intermittently, visited ENT @  Med Ctr for sore throat, ear pain & advised possible allergy; experienced joint pain in fingers, wrist, slight swelling in right knee & ankle; 02/06 - Emergency Rm vist to Med Ctr for burning rash on body; Mar 06 -Visit to Family Clinic for rash on body; Mid 4/06 - sore throat continued with high fever, body pain & swelling of fingers, wrists, knees, ankles & feet; Hospitalized: 4/17/06 @ Med Ctr; Diagnosis - Undetermined, Discharged 5/9/06; Hospitalized: 5/10/06 - Hospital, 2; Diagnosis 5/25/06: Adult Onset Still Diease (intially 60 mg of Prednisone, reduced to 3 mg; at present, regular visits have continued w/ treating physician since hospital discharge date - Dr. 11/9/07-records received from patient for hospital stay DOS 5/10-5/26/06-DC DX: Still disease. Temp 102.2, Bilateral axillary lymphadenopathy. Leukocytosis. Generalized body pains, weakness and extensive mascular rash especially on tongue and chest.			Y	Y	Y	15			N	11/08/2005	12/01/2005	23	Military medical records, military vaccine administration record, civilian medical/hospital records, treating physicians clinical notes available upon request  11/9/07-records received-Bone marrow biopsy normal. Serology normal. Blood culture staphylococcus. CT of chest, abdomen and pelvis showed some inflammatory changes around appendix. Colonoscopy negative. CT Angiogram negative. Echocardiogram negative.	MIL	OTH	None prior to vaccination	None prior to vaccination	No significant past medical history			1						1	Arthralgia; Ear pain; Influenza like illness; Joint swelling; Lymphadenopathy; Pain; Pharyngolaryngeal pain; Pyrexia; Rash; Skin burning sensation	FLUN3~MEDIMMUNE VACCINES, INC.~500356P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Life Threatening,Hospitalisation	Influenza
0295867	11/07/2007	MO	40.0	40		M	11/07/2007	Fever < 101F; Extreme body ache, Nausea, Shivering, head ache which advil or tylenol would not control taken at max levels. Both shots were given in same arm and that arm had stiff/cold fingers. Arm sore to touch and could not raise.  These happened the evening of the shot.  The next day:  fever <101F, shivering, body stiffness, stiff neck and joints, massive headaches, sore throat when swallowing, skin sensitivity to the point where hair/follicles hurt, red oval area around shot area. Next evening:  flu-like symptons, shivering then during sleep woke up completly wet with sweat.  11/7/07: Redness around shot area and tender to touch.									N	11/05/2007	11/05/2007	0	Get yearly influenza shots, never had such symptions.  Seven years ago had pneumo shot: no reaction-given with flu shot but different arms.	UNK	UNK		None	None			1						1	Chills; Headache; Hyperhidrosis; Injected limb mobility decreased; Injection site erythema; Injection site pain; Mobility decreased; Musculoskeletal stiffness; Nausea; Pain; Pain in extremity; Peripheral coldness; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PNC~PFIZER\WYETH~~UNK~IM~~PNEUMO (PREVNAR)~1	USA		Influenza
0295868	11/07/2007	MD	34.0	34		F	11/07/2007	Patient reported a fuzzy tongue feeling about shortly after injection.  She took oral benadryl 25mg.  Pt was observed for about 15-20 min., but symptoms were slowly increasing to the point of her feeling a lump in her throat.  At this point another 25mg of benadryl IM along with Epi 1:1000 SQ was given.  Pulse was noted, and within a few moments, patient reported lump was decreasing in throat and tingling of the tongue had stopped.									Y	11/02/2007	11/02/2007	0		UNK	PVT	Unknown	None	On-going work with physician to discover new food, food additive, and other medication allergies since an allergic reaction in March of 2007.			1						1	Paraesthesia oral; Sensation of foreign body	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80073~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295870	11/07/2007	IN	60.0	60		F	11/07/2007	Patient report that at 3am 11/2/07 she experienced vomiting, diarrhea, chills and has 3-4 more bouts of vomiting and diarrhea into the day. She was not able to eat anything on 11/2 and did not go to work on 11/2 and 11/3. She reported these events to me today 11/7. She no long has vomiting or diarrhea but still does not feel well.									U	11/01/2007	11/02/2007	1		PUB	PVT						1						1	Chills; Diarrhoea; Malaise; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLAO31AA~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0295877	11/07/2007	NJ	68.0	68		M	11/05/2007	Ascending lower extremity weakness, loss of reflexes consistent with Guillain Barre. Mild improvement of already mild symptoms.  11/27/07 Reviewed hospital medical records which reveal patient experienced sudden onset of bilateral lower extremity weakness beginning 4 days prior to admit.  Seen by several physicians prior to admit including neurologist who performed EMG/NCS & diagnosed w/GBS.  Admission to hospital 10/25-10/30/2007.  Exam on admit revealed areflexia.  LP revealed elevated protein & glucose. Tx w/IVIG x 5 days & improved.  D/C to home w/pcp & neuro f/u. FINAL DX: Guillian Barre syndrome.					Y	5			Y	10/11/2007	10/24/2007	13	Nerve Conduction Studies; Neurologic exam consistent: increased protein in spinal fluid. LABS: EMG/NCS revealed changes c/w GBS.	PVT	PUB	LISINOPRIL; COREG; FLUROSEMIDE; GLYBURIDE; CADUET	No	Diabetes, Hypertension; Peripheral Vasc. Disease; Coronary artery disease .			1						1	Areflexia; CSF protein increased; Guillain-Barre syndrome; Muscular weakness; Neurological examination	FLU3~SANOFI PASTEUR~U2469AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0295878	11/07/2007	PA	62.0	62		F	11/06/2007	Guillain-Barre (alleged) 11/16/07-records received for DOS 10/13-11/7/07-DC DX: Guillain Barre syndrome (acute inflammatory demyelinating polyneuropathy), status post IVIG treatments with 10 day course. Exacerbation of chronic obstructive pulmonary disease. Hypertension. Pulmonary hypertension. Schizophrenia. Depression.  Admitted with weakness, shortness of breath and hyponatremia. Severe weakness and numbness of arms and legs. Onset uncertain. Bell's phenomenon is apparent when she blinks. Weakness of orbicularis oculus muscles bilaterally. Pin sens of extremities blunted. Loss of deep tendon relexes and proprioception as well as sensation to light touch and pain. Severe sensori-motor polyneuropathy. Per 60 day follow up: Minimal residual still recovering.				Y	Y	25	Y		Y	10/05/2007	10/25/2007	20	request inpatient records (10.5.07) 11/16/07-records received-Sodium 124, potassium 3. Respiratory acidosis.. Venous doppler negative for DVT. Lumbar puncture protein 59 and glucose 72. Diastolic dysfunction single B-Natriuretic peptide 125.	PVT	PVT	Many	No	Penicillin; aspirin; Sulfa; Codeine 11/16/07-records received-Exacerbation of chronic pulmonary disease. Hypertension. Pulmonary hypertension. Schizophrenia. Depression. Recent gastrointestinal bleeding, post colonoscopy.			1						1	Guillain-Barre syndrome	FLU3~SANOFI PASTEUR~U2500AA~2~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0295879	11/07/2007	MO	1.5	1	.5	M	11/07/2007	Afebrile seizure activity 11/26/07-records received for DOS 11/6/07-DX: afebrile tonic clonic seizure and previously diagnosed with febrile seizures. Admitted for overnight observation. Temp in ED 98.7.					Y	1			Y	11/05/2007	11/06/2007	1	11/26/07-records received-CBC neurtrophils elevated, monoctyes elevated. BUN/creatine ration high. Anion Gap high. CT head no acute cerebral hemorrhage.	PVT	UNK	Diastat gel as needed	None	Febrile seizures 11/26/07-records received- PMH: hospitalization for febrile seizure and also complex febrile seizure. Family history of seizures.			1						1	Convulsion	FLU3~SANOFI PASTEUR~UT2460FA~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0170~3~UN~LL~POLIO VIRUS, INACT. (IPOL)~1	USA	Hospitalisation	Influenza
0295880	11/07/2007	MT	68.0	68		M	11/07/2007	Patient came to pharmacy 11/6/07 complaining of arm pain thought was from Flu shot. Patient recovered Fluzone 10/23/07 + no problems saving injection or injection site problems. Pharmacist called patient 11/7/07 and patient said he had normal soreness from Flu shot baton 11/4/07 got noticeably worse said had shoulder/arm pain from shoulders to elbow) hurt enough to cause trouble sleeping on arm. Saw his physician and physician prescribed Methylprednisolone pak				Y					N	10/23/2007	11/04/2007	12		OTH	PUB		None				1						1	Musculoskeletal pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2499AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295881	11/07/2007	CA	2.0	2	.6	F	10/30/2007	Superficial Erythema & mild skin breakdown at injection site				Y					U	10/03/2007	10/29/2007	26		PVT	UNK	None	None	None			1						1	Injection site erythema; Skin disorder	FLU3~SANOFI PASTEUR~0001U~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~Ut2456fA~2~IM~LL~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0295882	11/07/2007	CA	50.0	50		F	11/07/2007	Fever of 102 started 1 day after immunization. WBC 38.1 + neutrophils 88. Now with mild headache 2 weeks after immunizations.				Y					Y	10/30/2007	10/31/2007	1	wbc 38.1, neutrophils 88, no bands Blood culture pending	OTH	UNK	Erythrocin, Phenergan, metformin, Lisimil, Lovastatin, Lasix, Glyburide Actos, Zoloft		Car Genital asplenia			1						1	Blood culture; Headache; Neutrophil count increased; Pyrexia; White blood cell count increased	FLU3~SANOFI PASTEUR~U2371AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~0698U~UNK~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PPV~MERCK & CO. INC.~C2770AA~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~U2488AA~UNK~UN~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0295884	11/07/2007	MA	1.7	1	.7	F	11/07/2007	11/7/07 FluMist given to 20 month old - No adverse effects known at this time.										11/06/2007				PVT	PUB	Fluor-A-day liquid .25mg/QD	None	None			1						1	Inappropriate schedule of drug administration; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~500486P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0295885	11/07/2007	CA	4.0	4		M	11/07/2007	Trunk erythematous rash along elastic wait band and few scattered pink papules on the knees that blacken.									U	11/05/2007	11/06/2007	1	None	PVT	PVT	a	ear infection	amoxicillin			1						1	Rash erythematous; Rash papular	FLU3~SANOFI PASTEUR~UT2456CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295886	11/07/2007	MA	2.0	2	.0	M	11/07/2007	Patient arrived at clinic for influenza vaccine. O.5 ml dose administered. Followed up with Patient's father 48 hours later. Child had mild fever over weekend. Treated with Tylenol. To note, older sibling had pre-existing cold symptoms.									Y	11/03/2007	11/04/2007	1	None	PUB	PUB		None	Hearing Loss; Developmental Delays			1						1	Pyrexia	FLU3~SANOFI PASTEUR~U2526AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295887	11/07/2007	HI	2.0	2	.0	M	11/06/2007	Swelling in right thigh where shots were given									Y	10/31/2007	10/31/2007	0		PVT	OTH			No known drug allergies			1						1	Injection site swelling	DTAP~SANOFI PASTEUR~~4~UN~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT2459KA~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0247U~2~UN~LL~HEP A (VAQTA)~1|HIBV~SANOFI PASTEUR~UF2115A~4~UN~RL~HIB (ACTHIB)~1	USA		Influenza
0295888	11/07/2007	AL	50.0	50		F	10/31/2007	Rash developed approximately 24 hours after vaccine, multiple erythematous patches, raised. Located on neck, chest, abdomen, arms, upper legs. One brief episode of shortness of breath.				Y					N	10/29/2007	10/30/2007	1	Rapid Strep - Negative	OTH	OTH	None	None	allergic peanuts, chocolate, cats			1						1	Dyspnoea; Rash erythematous; Streptococcal identification test; Streptococcal identification test negative	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79282~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0295890	11/07/2007	WA	40.0	40		F	11/01/2007	Muscle soreness/cramping/pain ongoing with no improvement. Reported 10/30/07. No longer any redness or soreness directly at injection site. Pain radiates down arm. Began after shot. Treated with over the counter analgesics and now Tramadol 50mg. Also suggested ice/cold compresses.									U	10/06/2007	10/07/2007	1		OTH	OTH	None on file					1						1	Injection site erythema; Muscle spasms; Myalgia; Pain in extremity	FLU3~SANOFI PASTEUR~2453~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295891	11/07/2007	MS	70.0	70		F	10/29/2007	Shot given at 9AM. By 2:30PM patient was nauseated, weak and hot all over. Right upper arm was swollen red and painful. She felt she couldn't move her arm. Stayed in bed Saturday. Sunday she felt a little better. Today (Monday) there is minimal swelling in her right arm. Her arms is tender with patches of red on her upper arm and it is stiff.									Y	10/26/2007	10/26/2007	0		PUB	PUB	PO Methotrexate; PO Folic Acid	None	Novocaine; Psoriasis			1						1	Asthenia; Erythema; Feeling hot; Injected limb mobility decreased; Musculoskeletal stiffness; Nausea; Oedema peripheral; Pain in extremity; Tenderness	FLU3~SANOFI PASTEUR~U2499AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~U858U~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295892	11/07/2007	IL	59.0	59		F	11/01/2007	States after getting immunization on 10/25/07, she had pain from her left shoulder up into neck lasting at least 8 days - taking Tylenol									Y	10/25/2007	10/26/2007	1		PUB	UNK						1						1	Musculoskeletal pain; Neck pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80435~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295893	11/07/2007	MD	64.0	64		M	11/06/2007	Patient cannot hear through right ear.				Y					N	10/26/2007	10/27/2007	1		PUB	PVT		None	None			1						1	Deafness unilateral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA305AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0295895	11/07/2007	OH	39.0	39		F	11/07/2007	Shot given at 10:30a-on 11/3/07. Arm started feeling funny about 6p.m. Took Advil. Had red rash at site of bandaid. Woke up next morning with hives on torso. Had a reverse sunburn in bra area.									Y	11/03/2007	11/03/2007	0		OTH	OTH		None	Allergy to latex			1						1	Burning sensation; Injection site erythema; Sensory disturbance; Urticaria	FLU3~SANOFI PASTEUR~U2505AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295896	11/07/2007	CA	67.0	67		F	11/07/2007	Stinging when she got the shot - then she could taste vaccine. A migraine started immediately. She was then achy and fatigue for a few days. Issues are now resolved.									Y	11/01/2007	11/01/2007	0		OTH	PUB		None	None			1						1	Dysgeusia; Fatigue; Immediate post-injection reaction; Migraine; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79489~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0295897	11/07/2007	VA	60.0	60		F	11/07/2007	Patient called to report previous reaction to vaccinations received on 10/31/07; patient states she developed hot red blotches (pneumococcal) injection site just a couple of hours after getting injections; blotches extended down to almost left wrist area on lateral aspect; later that afternoon the blotches were on inner aspect as well; at about 6pm she developed tightness in her throat and chest; she took 2 puffs of Maxair and Benadryl 50mg po and tightness resolved after 30-40 minutes; she stated that the pain in her upper arm was a 6-7 on a scale from 1-10, 10 being intense worst experienced) she used ice and later heat but did not take analgesics; on 11/3/2007 she states pain, redness and blotches had resolved; patient instructed to seek emergency care in the future if similar chest and throat tightness were to occur, instructed patient to discuss with doctor at her next visit to decide about vaccinations in the future; patient agreeable; will mark alert on Immunization record; VAERS report faxed.									Y	10/31/2007	10/31/2007	0		PVT	PVT		Not Known				1						1	Chest discomfort; Injection site erythema; Injection site warmth; Pain in extremity; Rash macular; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~0991U~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~AFLUA280CA~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0295898	11/07/2007	CA	42.0	42		F	11/07/2007	30 hrs after vaccination, pt had sudden onset of severe nausea, anxiety, and dizziness.  The dizzines persisted up to the time of reporting.									Y	11/05/2007	11/06/2007	1	None	MIL	MIL	Synthroid	None	None			1						1	Anxiety; Dizziness; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLAO50AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0295899	11/07/2007	WI	76.0	76		M	11/07/2007	Received flu vaccine on Oct. 5.  Awoke next day with severe neck pains.  Pain worsened making it difficult to lay head down on pillow or raise head.  On Oct. 15 went to Urgent Care.  Received pain med. & muscle relax. and referred to own doctor.  Saw Dr. on Oct 18, who conferred with a neurologist re: possibility of GBS.  Warned to to watch for numbing, tingling or weakness of extremities.  Provided 3 Celebrex.  Awoke Oct 19 soaking wet with sweat, but much less neck pain.  Continued slow improvement after that date.  Fine now.									Y	10/05/2007	10/06/2007	1		UNK	UNK		None		None~ ()~~0.00~In Patient		1						1	Hyperhidrosis; Neck pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0295901	11/07/2007	VA	65.0	65		F	11/07/2007	about 20 minutes post-injection, nose & cheeks became red & swollen; voice became raspy, difficulty breathing, called PMD.  took 25 mg Benadryl & within 20 minutes symptoms resolved; 3:30 pm symptoms returned - took another Benadryl (25 mg) & again symptoms resolved.  10 am on 11/7/07 - symptoms did not return; feels fine.  has had flu vaccine each year before.  10/01/2007, received PPV23 @ PMD; injection site reaction:  swelling, redness, soreness, itching; resolved over 4 days - Benadryl; in 1995 had reaction to flu vaccine (below)									Y	11/06/2007	11/06/2007	0	N/A	PUB	PUB	prednisone q d	N/A	not formally tested; reacts to foods, sometimes carpets	tightness in chest; nasal congestion~Influenza (Seasonal) (no brand name)~UN~55.00~In Patient	VA07:024	1						1	Dysphonia; Dyspnoea; Erythema; Injection site erythema; Injection site pain; Injection site pruritus; Injection site reaction; Injection site swelling; Swelling face	FLU3~SANOFI PASTEUR~U2523AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295905	11/07/2007	MS	38.0	38		F	11/07/2007	I recieved vaccine around 5:00pm and before i left the building {approx 5 min.} my tongue felt numb, an hour or so later my lips felt numb{all on right side}i still wasnt too concerned and tried not to think about it the next day.I awoke sat.morning and my entire right side of my face was paralysed.i thought i was having a stroke, i look like ive had a stroke but doctor says bells palsy i researched the web and found numerous reports of this reaction but have never been told that it could be caused from flu vaccine.I would rather have had the flu.It has now been a week and im not better.				Y					N	11/01/2007	11/01/2007	0		UNK	UNK		none	none			1						1	Facial palsy; Hypoaesthesia oral	FLU3~SANOFI PASTEUR~unknown~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295911	11/07/2007	DC	1.25	1	.3	M	11/07/2007	Swelling, redness, warmth and tenderness to Right Leg.  Given Keflex 125mg/5ml 2 times per day for 10 days.				Y					U	10/30/2007	10/31/2007	1	none	PUB	PUB			CHF S/P CARDIOMYOPATHY MYOCARDITIS			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	DTPHIB~SANOFI PASTEUR~U17233C~1~IM~RL~DTP + HIB (DTP + ACTHIB)~1|FLU3~SANOFI PASTEUR~U2490AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08700H~4~SC~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0295912	11/07/2007	ID	0.75	0	.8	F	11/07/2007	fever of 104 via pacifier thermometer day of flu vaccine, tylenol given									U	11/07/2007	11/07/2007	0	pt cathed in office, cath urine dip normal, culture pending	PVT	PVT						1						1	Culture; Pyrexia; Urine analysis normal	FLU3~SANOFI PASTEUR~UT2459MA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0295913	11/07/2007	WA	17.0	17		F	11/07/2007	Pt received Fluzone (single dose preservative-free vial) flu shot, immediately felt itchy and hot afterward, was taken to exam room for observation, developed generalized flush & hives within next 2 minutes, tachycardic to over 160bpm, pt then reported difficulty breathing & start of wheezing, 911 called, dyspnea dissipated as epi injection was readied, O2 @2Lpm via face mask started, pt remained alert & responsive.  Mom denied known egg allergy, reported pt to have history of multiple hypersensitivities but no prior anaphylaxis.				Y					Y	11/03/2007	11/03/2007	0		PUB	PUB	None	NO	Herbal drugs, shellfish			1						1	Dyspnoea; Feeling hot; Flushing; Immediate post-injection reaction; Injection site pruritus; Injection site warmth; Oxygen supplementation; Pruritus; Tachycardia; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U2461DA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295915	11/07/2007	MA	1.17	1	.2	M	11/07/2007	Fever and febrile seizure evening after vaccines given				Y					Y	11/05/2007	11/05/2007	0		PVT	UNK		None	Febrile seizure x1 10/12/2007			1						1	Febrile convulsion; Pyrexia; Condition aggravated; Febrile convulsion; Pyrexia	FLU3~SANOFI PASTEUR~u2479aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~UNKNOWN MANUFACTURER~uf195aa~4~IM~RA~HIB (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0183u~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~b47442e~4~IM~RA~PNEUMO (PREVNAR)~1|FLU3~SANOFI PASTEUR~U2479A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~SANOFI PASTEUR~UF195A~4~IM~RA~HIB (ACTHIB)~2|MMR~MERCK & CO. INC.~0183U~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~2|PNC~PFIZER\WYETH~B47442E~4~IM~RA~PNEUMO (PREVNAR)~2	USA	Emergency room visit	Influenza
0295918	11/07/2007	OH	59.0	59		F	11/07/2007	rash knee-up; raised bumps; sometimes itches				Y						10/12/2007				OTH	PVT						1						1	Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA294EA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0294648	11/08/2007		59.0	59		F	11/08/2007	We received from a health care professional via the medical agencies following information on 29 OCT 2007: A 59-year-old woman, born on 01 AUG 1948, was vaccinated with Fluvirin, batch-no. 78994, i.m. on 16 OCT 2007 (18 OCT 2007) was also reported). A sore arm was reported on 18 OCT 2007. She was admitted into the hospital on 19 OCT 2007 with cellulitis of the left arm. Patient was currently in ICU on a ventilator at time of report (29 OCT 2007). Company assessment: Seriousness criterion: hospitalisation. Causality: insufficient data. Expectedness assessment according to manufacturer label: The reported symptoms, except for sore arm, are not expected after Fluvirin. On a case level, the case is considered unexpected. No change in benefit-risk-ratio. No measures necessary. NA07-005653					Y				N	10/16/2007	10/19/2007	3		OTH	OTH	No other medications	Unknown			MA20071250	1						3	Asthenia; Cellulitis; Intensive care; Mechanical ventilation; Cellulitis; Influenza like illness; Injected limb mobility decreased; Injection site erythema; Injection site pain; Injection site warmth; Multi-organ failure; Surgery; Cellulitis; Intensive care; Mechanical ventilation; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78994~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78994~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~3	USA	Hospitalisation	Influenza
0295917	11/08/2007	CA	45.0	45		F	11/08/2007	tingling arms and legs, muscle weakness, headache, muscle pain, chills, numbness, shortness of breath, dry cough, rapid heart beat, fatigue, loss of balance				Y					N	10/24/2007	10/24/2007	0		PVT	PVT	amoxicillin, flonase	some sinus	ileostomy, sinus,			1						1	Balance disorder; Chills; Cough; Dyspnoea; Fatigue; Headache; Heart rate increased; Hypoaesthesia; Muscular weakness; Myalgia; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0296070	11/08/2007	MI	61.0	61		M	11/08/2007	This case was reported by a consumer and described the occurrence of lethargy in a 61-year-old male subject who was vaccinated with (Flulaval, GlaxoSmithKline) for prophylaxis. The reporter is the subject. A physician or other health care professional has not verified this report. The subject's medical history included deafness in one ear, heart attack and high blood pressure. The subject reported that 10 years ago he had a flu shot and had a cold all that winter. Since then, the subject has had a flu shot yearly and has not had any problems. Concurrent medications included Omeprazole (Prilosec), Aspirin (Baby ASA), Atorvastatin calcium (Lipitor) and Clopidogrel bisulphate (Plavix). On 18 October 2007 at 5:00 p.m. the subject received unspecified dose of Flulaval (.5 ml, unknown). A few hours later, on 18 October 2007, less than one day after vaccination with Flulaval, the subject experienced lethargy, tightness in his throat and a dry cough. At 3:30 a.m. on 19 October 2007, the subject experienced night sweats and chills. On 04 November 2007 the subject experienced dizziness and noise in his ears. On an unspecified date, less than one month after receipt of Flulaval, the subject experienced difficulty with mental focusing. The subject was seen at a physician's office. The subject considered the events to be disabling. At the time of reporting the outcome of the events were was unspecified.				Y				Y	U	10/18/2007	10/18/2007	0	UNK	PVT	PVT	Omeprazole; Aspirin; Atorvastatin calcium; Clopidogrel bisulphate	Unknown	The subject reported that 10 years ago he had a flu shot and had a cold all that winter. Since then, the subject has had a flu shot yearly and has not had any problems.		A0693073A	1						1	Chills; Cough; Disturbance in attention; Dizziness; Lethargy; Mental impairment; Night sweats; Throat tightness; Tinnitus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Disabling	Influenza
0296071	11/08/2007	LA	54.0	54		F	11/08/2007	This case was reported by a healthcare professional and described the occurrence of injection site soreness in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis. On 5 October 2007 the subject received unspecified dose of Flulaval (.5 ml, unknown, unknown arm). On 5 October 2007, less than one day after vaccination with Flulaval, the subject experienced injection site soreness that was considered to be extreme. The reporter also noted that the arms continued to be tender. Pharmaceutical product complaint was also identified. It was not reported of the subject had previously received any influenza injections. Also any previous reactions following vaccinations was also not reported. At the time of reporting the events were improved. The healthcare professional considered the events were probably related to vaccination with Flulaval. Follow-up was received by the healthcare professional on 07 November 2007. At the time of the events, the subject was 54 years of age. Medical history included tobacco use of one-half pack daily and alcohol use reported as few weekends. On 5 October 2007, the subject received an injection of Flulaval in the left arm. On 5 October 2007, less than one day after vaccination with Flulaval, the subject experienced tingling and numbness of the lips and tongue, body aches, bronchospasm, injection site soreness, arm tenderness and product complaint. Review of a hospital bill indicated that the subject was transported via ambulance to an emergency room on 5 October 2007 and hospitalized. The hospital bill indicated that the subject received Ketoralac tremetamol, Betamethasone acetate + betamethasone sodium phosphate, Ipratropium bromide + salbutamol sulphate and respiratory therapy. The events resolved with sequelae on 11 October 2007. The healthcare professional considered the events were probably related to vaccination with Flulaval.				Y	Y	0			N	10/05/2007	10/05/2007	0	UNK	PVT	PVT		Unknown	Medical history included tobacco use of one-half pack daily and alcohol use reported as few weekends. The healthcare professional reported that 6 other subjects experienced injection site soreness following receipt of Flulaval. Please see cases A0687720A, A0687732A, A0687734A, A0687735A and A0687736A.		A0687733A	1						1	Bronchospasm; Hypoaesthesia oral; Injection site pain; Pain; Pain in extremity; Paraesthesia oral; Pharmaceutical product complaint; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA037AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation	Influenza
0296073	11/08/2007		89.0	89		M	11/09/2007	We received from a health care professional via the agency following information on 29 OCT 2007: A 89-year-old man, born on 15 JUL 1918, was vaccinated with Fluvirin, batch-no. 78428, i.m. on 23 OCT 2007. The patient died shortly after the vaccination after he left the facility and walked down the hall. Caller felt that individual was properly screened, reported no allergies to any component, and filled out the waiver for the vaccine prior to administration, and had prior flu vaccinations. The reporter felt the death was coincidental based on the age and history of the patient. Company assessment: Seriousness criterion: death. Causality: insufficient data. Expectedness assessment according to manufacturer label: Death after Fluvirin is not expected. No change in benefit-risk-ratio. No measure necessary. Addendum We received from a health care professional via the medical agencies additional information on 29 OCT 2007: The batch-no. was 78478 (and not 78428 as previously reported). No change in assessment. NA07-005622	Y	10/23/2007							N	10/23/2007	10/23/2007	0		OTH	OTH	No other medications	Unknown			MA20071247	1						1	Death	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78478~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0296074	11/08/2007	TX	71.0	71		F	10/11/2007	(1) Cellulitis Rt arm (2) Local Reaction Lt arm 11/13/07-records received for DOS 10/11/07-DX: Acute allergic reaction and cellulitis of right upper limb. Slight reaction to flu vaccine, more reaction to pneumonia vaccine. Gastric bezoar, having problems with eating. Developed swelling and tenderness and pain with painful movement of right shoulder. Swelling and pain right upper arm around injection site and extending to right axilla.				Y					Y	10/10/2007	10/10/2007	0	10/11/07 - CBC -; WBC - 5.3; RBC - 3.24; Hg - 10.6; Hct - 30.8; MCH - 32.6; CMP normal; U/A bacteria 2+; bloody 4+; protein 3+ 11/13/07-records received- CXR: cardiomegaly and small loculated effusion in lateral left thorax.Lymphoctyes 15.8, PT 13.8, beside glucose 278.	UNK	UNK			Allergies - Compazine, PCN, Codeine; DM II, GERD, Hepatitis C, cirrhosis of liver, irritable bowel syndrome, arthritis L-spine 11/13/07-records received-HX of diabetes mellitus type II, cirrhosis of liver and hepatitis C, ascites, chronic pleural effusion, hiatal hernia, gastoesophageal reflux disease and irritable bowel syndrome, congestive heart failure and chronic pulmonary obstructive disease.			1						1	Bacteria urine; Cellulitis; Full blood count; Haematocrit decreased; Haematuria; Haemoglobin decreased; Local reaction; Mean cell haemoglobin normal; Metabolic function test normal; Proteinuria; Red blood cell count decreased; Urine analysis abnormal; White blood cell count normal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA03AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1035F~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0296076	11/08/2007	OR	35.0			M	10/29/2007	Had Flu vaccine 10-18-07, Fluarix A310AA lot #. On 10-22-07 developed rash over sternum to (R) rib cage area, that is clearly shingles with vesicular lesions. No prior case of shingles. Hx chickenpox in past. 11/14/07-patient not hospitalized, recovering from shinges.									U	10/18/2007	10/18/2007	0		UNK	UNK						1						1	Blister; Herpes zoster; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~A310AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296077	11/08/2007	CA	40.0	40		F		Symptoms of brachial neuritis on side of injection. 11/13/07-office notes for DOS 10/25/06-received-DX: allergic rhinitis.  11/14/07-records received for DOS 10/26-11/1/07-office notes-presented on 10/26/07 with pain left arm, shooting pain shoulder to elbow, elbow to 5th finger. Dull pain. No swelling, warm, or tenderness. No weakness. DX: brachial neuritis secondary to vaccination. 11/1/07-brachial neuritis resolved.				Y					Y	10/15/2007	10/23/2007	8		PVT	UNK	Thyroid replacement	None	Environmental allergies			1						1	Radiculitis brachial	FLU3~SANOFI PASTEUR~U2440AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296078	11/08/2007	TN	1.1	1	.1	M	11/08/2007	temperature of 104.2 after immunizations				Y						11/07/2007	11/08/2007	1	flu screen (-); CBC WNL	PVT	PUB	motrin for fever	teething rectal temp 99.0	none	none~ ()~~0.00~In Patient|none~ ()~~0.00~In Sibling		1						1	Body temperature increased; Full blood count normal; Influenza serology negative	FLU3~SANOFI PASTEUR~U2476HA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB182AA~1~IM~LL~HEP A (HAVRIX)~1|HIBV~MERCK & CO. INC.~0437U~3~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08700H~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0296079	11/08/2007	CO	32.0	32		F	11/08/2007	after shot given arm (at injection site) swelled to size of golf ball and began bleeding. Swelling decreased after several hours - forearm and wrist have pain difficulty rotating wrist very painful - pain continues after 2 weeks.									N	10/25/2007	10/25/2007	0		OTH	OTH	None	None	None	None~ ()~~0.00~In Patient		1						1	Arthralgia; Injection site haemorrhage; Injection site swelling; Pain in extremity	FLU3~SANOFI PASTEUR~U2453AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296084	11/08/2007	NY	42.0			F	11/08/2007	None stated				Y					Y	11/08/2007	11/08/2007	0	UNKNOWN	OTH	OTH		UNKNOWN	UNKNOWN			1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80961~7+~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0296085	11/08/2007	NY	20.0			F	11/08/2007	headache, increased heart rate, Swelling to. ips, diaphoresis, limbs shaking				Y					Y	11/08/2007	11/08/2007	0	UNKNOWN	OTH	OTH	UNKNOWN	No	NO KNOW Allergies			1						1	Headache; Heart rate increased; Hyperhidrosis; Lip swelling; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~B0961~7+~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0296086	11/08/2007	NC	52.0	52		F	11/07/2007	Patient woke up morning after flu vaccine swollen lip and cheek left side									U	11/06/2007	11/07/2007	1		PVT	UNK		no	Asthma/Hypertension/Hypothyroid	Swollen lips (years after - has had multiple flu shots)~Influenza (Seasonal) (no brand name)~1~0.00~In Patient		1						1	Lip swelling; Swelling face	FLU3~SANOFI PASTEUR~U2494AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296087	11/08/2007	WI	66.0			F	11/08/2007	that day had soreness of right arm - felt ill. Site red following pneumococcal vaccine adm. Rash chest - back and shoulder									Y	11/06/2007	11/06/2007	0		PVT	PVT	OTC loratadine; Glucosamine, progesterone cream		Sulfa: degenerative arthritis, airway allergies.			1						1	Injection site erythema; Malaise; Pain in extremity; Rash	FLU3~SANOFI PASTEUR~U2464AA~4~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0200U~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296088	11/08/2007	MO	15.0	15		F	11/08/2007	cellulitis at site of injection				Y					Y	11/01/2007	11/02/2007	1		PVT	UNK						1						1	Injection site cellulitis	FLU3~SANOFI PASTEUR~UT251AA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1265U~2~IM~RA~HPV (GARDASIL)~1|VARCEL~MERCK & CO. INC.~180U~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0296090	11/08/2007	PA	49.0	49		F	11/08/2007	Marked bruising at injection site = 3cm in diameter. Redness, swelling, firm warm tissue below injection site - area approx 10 cm x 8cm - Symptoms resolving									Y	10/29/2007	10/29/2007	0	None	OTH	PVT	Avelox, Demulen, Prilosec	Otitis Media	Penicillin Drug Allergy			1						1	Erythema; Injection site bruising; Skin induration; Skin warm; Swelling	FLU3~SANOFI PASTEUR~U2487AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296091	11/08/2007	IL	62.0	62		F		Patient stated she got the flu 7days after her shot and had to go to Emergency Room				Y					Y	10/16/2007	10/23/2007	7		OTH	PVT		none				1						1	Influenza	FLU3~SANOFI PASTEUR~U2493AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296094	11/08/2007	VA	3.0	3		F	11/07/2007	PATIENT WAS ADMINISTERED 0.5 CC OF FLUZONE IN LA/IM DURING ROUTINE ASTHMA CHECK. PARENT NOTICED SEIZURE/FEVER AT 11PM THAT SAME DAY. PARENT PHONED PCP WHO ADVISED ER WHERE PT WAS STABILIZED. THE SEIZURE WAS A GENERALIZED TONIC-CLONIC VARIETY MOTHER STATES PT HAS ALLERGY TO CEFZIL, HAS NO PRIOR ADVERSE REACTIONS TO VACCINES, AND HAS H/O SEIZURES; THIS IS #4: PT FOLLOWED UP WITH PCP 11-7-07				Y					Y	11/05/2007	11/05/2007	0		PVT	PVT	SINGULAR 4mg, ALBUTEROL, SEBULES	NONE	ASTHMA			1						1	Convulsion; No reaction on previous exposure to drug; Pyrexia; Tonic clonic movements	FLU3~SANOFI PASTEUR~U2451AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296096	11/08/2007	NY	58.0	58		F	11/08/2007	Developed hives on Face; swelling of lips; relief with Benadryl po.									Y	11/06/2007	11/06/2007	0		PVT	PVT	None	None	denied by her			1						1	Lip swelling; Urticaria	FLU3~SANOFI PASTEUR~U2451AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296097	11/08/2007	CA	58.0	58		M	11/07/2007	(11/2/07) Patient called on Friday at 1:30pm complained sorethroat and difficulty in swallowing. The immunizer recommended him to take Benadryl. We called him back on Monday (11/5/07) to follow up. Patient said he was feeling fine after 3 doses of Benadryl.									Y	11/01/2007	11/02/2007	1		OTH	OTH		None				1						1	Dysphagia; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U2488AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296099	11/08/2007	MO	78.0	78		F	11/07/2007	c/o itching after leaving the clinic on 11/2/07. Right arm. Area about 3 1/2 inches x 2 1/2 inches, swollen, painful shivering Friday night. Per patient. Staff did not observe reaction.									Y	11/02/2007	11/02/2007	0	None	PVT	OTH	HCTZ, Premarin, Calcium, Timolol, Xalatan	NONE	Beef, Latex			1						1	Chills; Oedema peripheral; Pain in extremity; Pruritus	FLU3~SANOFI PASTEUR~U2464AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~1080U~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0296100	11/08/2007	TX	51.0	51		M	11/08/2007	chills/sweats the night after the shot, 101 temp the following morning, chest pain, heaadache.									U	11/07/2007	11/07/2007	0		UNK	PVT	Aciphex, Donovan	None	None			1						1	Chest pain; Chills; Headache; Night sweats; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFIUH3C7CH~1~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296101	11/08/2007	AZ	49.0	49		F	11/08/2007	my arm has been in pain ever since,my doctor is sending me to a nerologist, thinks there is nerve damage. I am up alot at night with pain. something happened with my shot,never happened before				Y					N	10/20/2007				UNK	UNK	none	no	no			1						1	Nerve injury; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0296103	11/08/2007	MO	36.0	36		M	11/08/2007	Difficulty sleeping, extremely sore arm, shoulder, armpit - Headache									N	11/05/2007	11/05/2007	0		UNK	PVT						1						1	Headache; Insomnia; Musculoskeletal pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0296105	11/08/2007	MO	46.0	46		F	11/08/2007	Bruising, aches, fever, chills, severe headache, arm sore and tender (top and bottom - tender to put on deodorant), pain shooting from shoulder to left ear									U	10/05/2007	10/05/2007	0		UNK	UNK		none				1						1	Chills; Contusion; Ear pain; Headache; Pain; Pain in extremity; Pyrexia; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0296106	11/08/2007	MO	31.0	31		F	11/08/2007	sore throat. chills, fever, pain in entire arm where injection was given, pain in neck and chest area.									Y	11/05/2007	11/05/2007	0		UNK	UNK						1						1	Chest pain; Chills; Injection site pain; Neck pain; Pain in extremity; Pharyngolaryngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0296107	11/08/2007	MO	36.0	36		F	11/08/2007	Extreme body aches, sore arm, fever, extreme chills, swollen glands									U	11/05/2007	11/07/2007	2		UNK	UNK						1						1	Chills; Lymphadenopathy; Pain; Pain in extremity; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0296108	11/08/2007	SC	69.0	69		F	11/08/2007	WITHIN 8 HOURS I EXPERIENCED CHILLS, FEVER, JOINT PAIN  AND A TERRIBLE HEADACHE.THESE SYMPTOMS LASTED FOR 24 HOURS.I WAS TOO ILL TO GET OUT OF BED AND FIND THE TYLENOL BOTTLE!									Y	11/05/2007	11/05/2007	0		PVT	PVT		NO ILLNESS WAS HAVING YEARLY PHYSICAL				1						1	Arthralgia; Chills; Headache; Malaise; Pyrexia	FLU3~SANOFI PASTEUR~U-2450AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296111	11/08/2007	PA	60.0	60		F	11/08/2007	Fainted, clammy, pale				Y					Y	11/07/2007	11/07/2007	0		UNK	UNK						1						1	Cold sweat; Pallor; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80824~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0296113	11/08/2007	ME	32.0	32		F	11/08/2007	Received vaccination at    am. At 2:30 I begain to feel nauseaous and lightheaded. By 4:30 I was shivering and experiencing muscle aches which progressed to fatigue, fever and general influenza like illness. I took an OTC flue remedy that night. I missed one day of work. Most of symptoms resolved by noon the next day, except for the fatigue which continued for the rest of the day. I am a nurse and have had numerous influenza vaccines (10+) with no previous reported effects.									Y	11/06/2007	11/06/2007	0	N/A	PVT	PVT	N/A	None	None			1						1	Chills; Dizziness; Fatigue; Influenza like illness; Myalgia; Nausea; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA051AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0296114	11/08/2007	MO	50.0	50		F	11/08/2007	Within 10 hours of vaccination, fever of 102.6, chills, body aches, pain at injection sight.  Following day, fever of 100.7 in the morning, then 101.6 in the evening.  Continued body aches and extreme fatigue.  Second day, pain at injection sight, fever of 99.7.  Third day, no fever or symptoms.  Took Tylenol to reduce fever.									Y	11/05/2007	11/05/2007	0	none	UNK	UNK	none	no	none			1						1	Chills; Fatigue; Injection site pain; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0296115	11/08/2007	MO	33.0	33		F	11/08/2007	stomach dicomfort, chest tightness, fever									Y	11/02/2007	11/03/2007	1		UNK	PUB	unknown	none				1						1	Chest discomfort; Pyrexia; Stomach discomfort	FLU3~SANOFI PASTEUR~u2528AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296117	11/08/2007	MO	48.0	48		F	11/08/2007	Fever (102), chills, severe body and joint pain, swollen, red & painful at the injection site, (right arm, flu like symptoms for 48 hours, then minor discomfort and coughing.									Y	11/05/2007	11/05/2007	0		UNK	PVT	none	none	none			1						1	Arthralgia; Chills; Cough; Influenza like illness; Injection site erythema; Injection site pain; Injection site swelling; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0296118	11/08/2007	TX	21.0	21		F	11/08/2007	11/05/07 Client was administered flu vaccine to left deltoid.  11/08/07 Client presented to office with redness swelling on the inner aspect of left arm where flu shot was given.  Encouraged client to apply ice pack if she felt it was needed and to take tylenol for pain.  Instructed client to call our office if swelling did not subside in a couple of days.									U	11/05/2007	11/08/2007	3		PUB	PUB	NONE.	NONE.	None.			1						1	Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~U2449AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296119	11/08/2007	FL	1.25	1	.3	M	11/08/2007	Fever that rapidly increased causing Febrile Seizures				Y					Y	11/02/2007	11/03/2007	1		PUB	PUB		NONE KNOWN	NONE KNOWN			1						1	Febrile convulsion; Pyrexia	DTAP~SANOFI PASTEUR~PMC C2749BA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~PMC UT 2474AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~SKB AHAVB182AA~1~IM~RL~HEP A (HAVRIX)~1|HIBV~MERCK & CO. INC.~MSD 0500U~3~IM~LL~HIB (PEDVAXHIB)~1|MMRV~MERCK & CO. INC.~MSD 0791 U~3~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~WYB 70143F~4~IM~RA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0296120	11/08/2007	WI	76.0	76		M	11/08/2007	Patient is suffering from Guillain Barre Syndrome. The patient presented about 9 days after flu vaccine administration with symptoms of weakness in his lower extremities and lower back pain.  The patient is currently intubated due to respiratory failure and has had 5 days of high dose IV immunoglobulin with no improvement. The patient is finishing his last round of plasmapharesis in the next day. During his time at the hospital he experienced elevated blood pressure which was hard to treat, he also had an increased core temperature for a couple of days. 12/17/07-records received for DOS 10/22-11/25/07-DC DX: Guillain-Barre syndrome. Persistent encephalopathy seconary to Guillain-Barre syndrome. Respiratory failure requiring mechanical ventilation. Death.  Presented to ED with severe back pain with increasing weakness. Back pain started on 10/21/07-Low back pain with some numbness and tingling in legs. Today unable to get up.  PE: mild quadriparesis along with mild sensory changes at distal extremities.Treated with IVIG. 5/15/09 Death certificate states COD as respiratory failure due to Guillain Barre syndrome.	Y	11/25/2007	Y	Y	Y	32	Y		U	10/09/2007	10/21/2007	12	Contrast MRI, Spinal tap, prolonged F wave response 12/17/07-records  received- Lumbar puncture showed cyto-albuminic disassociation, elevated protein and enhancement of lumbar roots on MRI. D-dimer elevated at 766. Increased segmented neutrophils 72%. Abdominal and pelvic CT normal. CT head showed small possible meningioma in left occipital parietal area not causing any of his problems. EMG F waves consistent with Guillain-Barre syndrome.	UNK	UNK	Nexium, Ambien, Lisinopril, Hydrochlorothiazide, Taztia XT, Aspirin, Doxazosin, Alprazolam, Tylenol #3.	none 12/17/07-records received-Headache which lasted over the last few weeks.	Hypertension, Coronary Artery Disease, Gastroesophageal Reflux Disease, Osteoarthritis, Atrial Fibrilation. 12/17/07-records received-PMH: coronary artery disease. Hypertension. Atrial fibrillation. Gastroesophageal reflux disease. Osteoarthritis. Insomnia.			1						1	Back pain; Blood pressure increased; Body temperature increased; Electromyogram abnormal; Guillain-Barre syndrome; Intubation; Lumbar puncture; Muscular weakness; Plasmapheresis; Respiratory failure	FLU3~SANOFI PASTEUR~U2464AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0296121	11/08/2007	TX	44.0	43		M	11/08/2007	Arm where shot was given was red, swollen ad warm to the touch.  He missed 2 days of work with flu-like symptoms, headaches and chills.									Y	10/23/2007	10/24/2007	1		UNK	UNK		Not Known.	Not Known.			1						1	Chills; Erythema; Headache; Influenza like illness; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~u2494aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296122	11/08/2007	MO	48.0			F	11/08/2007	Extreme chills, fever, extreme fatigue, body ache, extreme soreness around shot site, swelling of gland under arm that received the shot, headache, 2 days later a red welt appeared along with a knot that has been at the shot site.  I alternated Tylenol and Advil, drank lots of fluids, rested ALL DAY the day after the shot, applied ice to shot site.  Took Benadryl at night after red welt appeared.									U					UNK	UNK	Allegra, Flonase as needed, Nexium as needed	I was healthy at the time I received the vaccination.	Seasonal allergies, acid reflux			1						1	Chills; Erythema; Fatigue; Headache; Injection site nodule; Injection site pain; Injection site reaction; Lymphadenopathy; Pain; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0296124	11/08/2007	PA	50.0	50		F	11/08/2007	received flu shot on 11/2/07. on 11/3/07 injection site (right arm) exam reveals area of redness and induration 5 cm in diameter with tenderness . c/o general body aches, malaise and fatigue. At present she feels better and local reaction is resolving.									Y	11/02/2007	11/03/2007	1		UNK	UNK						1						1	Fatigue; Injection site erythema; Injection site induration; Injection site pain; Local reaction; Malaise; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA031AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0296126	11/08/2007	NY	1.5	1	.5	M	11/08/2007	Received DTaP 2 days ago to upper right thigh. Parent noticed increased redness and swelling to right thigh the following day. Patient afebrile and acting fine. Area of 2.5inches x 2.5inches of redness, non-tender.									Y	11/06/2007	11/07/2007	1		PVT	PVT		Upper respiratory infection				1						1	Injection site erythema; Injection site swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B061AA~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2474CA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0495U~1~IM~LL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~0786U~1~SC~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0296127	11/08/2007	NY	45.0	45		F	11/08/2007	3cm area of ecchymosis on left upper arm overlying injeciton site: no redness, no warmth, distal pulses normal, distal neuro normal. Diagnosis - contusion left upper arm.  GIven instructions to observe for increase size, redness, pain, warmth, swelling.									Y	11/07/2007	11/07/2007	0	N/A	UNK	UNK	Unknown	None	Unknown			1						1	Contusion; Ecchymosis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79897~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0296128	11/08/2007	GA	1.25	1	.3	F	11/08/2007	CELLULITIS LEFT LEG									Y	10/29/2007	11/08/2007	10		PVT	PVT	NONE	NONE	NONE			1						1	Cellulitis	DTAP~SANOFI PASTEUR~C27658A~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2457DA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB186AA~1~IM~LL~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~0306U~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0296131	11/08/2007	TX	62.0	62		F	11/08/2007	From chin to shoulders, it looked like a sunburn and had fever in it. The area where the shot was given had a 3 diameter red place with fever in it. The rest of the body had a rash with large bumps about 1/4 in diameter. Treatment was, the patient took Claritin.									Y	11/02/2007	11/03/2007	1		UNK	PVT		none				1						1	Erythema; Injection site erythema; Injection site warmth; Pyrexia; Rash generalised; Skin warm	FLU3~SANOFI PASTEUR~~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296132	11/08/2007	MO	42.0	0	.0	F	11/08/2007	I received the Pneumococcal vaccine and the Influenza vaccine in my rt. deltoid at approx. 0815 Monday, 11/5/07. That evening I felt feverish, weak, fatigued, the rt. axillary hurt and the lymph nodes in the throat and neck hurt.  The rt. arm appeared swollen as well as the rt. axillary.  The rt. arm, wrist and hand ached and was swelling to the point that a fist could not be made.  By the next morning, I could hardly move my arm and it was painful under the rt. arm and the rt. deltoid.  I had a fever of 100.3, and the rt. hand was ice cold all day.  On Wed. 11/7/07, still running a fever, saw the doctor due to some red raised welts that were appearing on the arm.  I was told to return in two days if it did not get better.  On 11/8/07 the red raised areas are larger and spreading.  There is more movement in the arm, but it is still very painful.  Still have a headache, some dizziness, body aches and feel very tired.				Y					N	11/05/2007	11/05/2007	0	No testing ordered.  The doctor is unsure if there is some kind of contaminent. He wants to see me back in two days if it is not better.	UNK	UNK	LoEstrin	The evening of vaccine.  See above.	Sulfa			1						1	Asthenia; Axillary pain; Dizziness; Fatigue; Headache; Injected limb mobility decreased; Oedema peripheral; Pain; Peripheral coldness; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0296133	11/08/2007	IL				M	11/08/2007	A scabbed area with pus; not red; about the size of a 50 cent piece									Y	10/30/2007	11/05/2007	6		PUB	UNK						1						1	Purulent discharge; Scab	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA300AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296134	11/08/2007	MS	64.0	64		F	11/02/2007	CALLED ON 11/1/07 C/O SORENESS AND REDNESS R ARM. SPOKE WITH HER AROUND 4 P.M. ARM WAS BETTER. CALLAED AGAIN 11/2/07 SWELLING AND REDNESS IN ARM IS WORSE AND RUNNING FEVER 101. REFERRED TO PMD AS SOON AS POSSIBLE				Y					Y	10/30/2007	10/31/2007	1	PMD GAVE DEPO MEDROL INJECTION	PUB	PUB		NO	NO		MS07027	1						1	Erythema; Oedema peripheral; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U2523AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0859U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0296135	11/08/2007	AL	43.0	43		F	11/08/2007	Patient with uncomplicated TAH prepared for discharge given pneumococcal vaccine in right deltoid. Subsequently developed severe swelling, redness and induarted patch approximating 8-10 cm in circumference on right shoulder. Became febile, lethargic, nausea and required admission to hospital for care. Infectious Disease consult for possible cellulitis. No infectious etiology determined. 12/06/07-records received for DOS 10/15-10/17/07-Right upper extremity pain and inflammation. Discharged day prior after hysterectomy. C/O elevated temperature with cellulitis at the injection site of pneumococcal vaccine administered day before. Seen in ED on 10/14/07- and discharged home, returned on 10/15/07 with temperature greater than 103.0 and progressing cellulitis. No improvement transferred to another facility for possible worsening cellulitis versus servere allergic reaction to vaccination. 12/7/07-receiving facility records for DOS 10/17-10/20/07-DC DX: right upper arm cellulitis vesus allergic reactions fo intramuscular vaccine.					Y	5			Y	10/14/2007	10/15/2007	1	WBC 11.0. No other pertinent data. All cultures negative. 12/7/07-records received-MRI negative for abscess. Blood, urine cultures no growth. WBC 10,000.	UNK	UNK	None	s/p TAH without complication 12/7/07-records received-status post total abdominal hysterectomy.	Mitral regurgitation,mitral valve prolapse 12/7/07-records received-HX of Depression.			1						1	Erythema; Induration; Lethargy; Nausea; Pyrexia; Swelling; White blood cell count	FLUX~UNKNOWN MANUFACTURER~Unknown~3~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~Unknown~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0296140	11/08/2007	MI	1.52	1	.5	M	11/08/2007	Patient was admitted after father found infant limp, unresponsive, but breathing comfortably in the crib.  In the EMS, patient experienced brief seizures, each lasting a few seconds, with stiffening, eye rolling, and some tremors of the extremities, with unresponsiveness. In ER, patient developed status epilepticus and received multiple doses of phenobarbital, phenytoin, and keppra.  On admission patient was febrile (104.7 F -rectal).  Patient was intubated secondary to being comatose with seizures for > 1 week.  Patient also developed visual impairment in one eye.  Patient was extubated and transfered to be treated in rehab.  11/9/07 Received hospital medical records which reveal patient experienced seizure activity with fever.  Admitted 10/21-11/8/2007.  PICU & intubated.  Neuro, ID & cardio consults done.  Given multiple antiseizure meds, steroids & versed drip.  Tx w/IV antibiotics & antiviral.  Extubated 10/31 & continued on oral meds.  Transferred by ambulance to hospital for inpatient rehabilitation. FINAL DX: complex febrile seizure, encephalopathy. 11/16/07 Received vax record which confirms lot # & was patient's 3rd flu shot. VAERS database updated w/same.					Y	19			U	10/16/2007	10/21/2007	5	CSF culture = positive for HHV7 AND MRI showed encephalopathy LABS: EEG revealed diffuse encephalopathy.  MRI of brain revealed changes c/w ischemic brain injury or metabolic disease.  CT brain WNL.  Echocardiogram & EKG WNL.  Liver enzymes elevated.  CSF done 10/22: WBC 6 (H), RBC 1505 (H), polys 84% (H), lymph 12% (L), protein 16, glucose 73 (H).  CBC 10/21: WBC 10 .6, lymphs 39.6% (L), monos 10.6 (H).  Developed MRSA from CVP line.  Chemistry 10/21: glucose 320 (H), BUN 19 (H), K 5.5 (H), AGAP 28 (H), Mag 2.4 (H).  Visual evoked potential WNL.	UNK	UNK	NONE	NONE	NONE			1						1	Body temperature increased; CSF culture positive; Coma; Convulsion; Encephalopathy; Extubation; Gaze palsy; Herpes virus infection; Hypotonia; Intubation; Musculoskeletal stiffness; Nuclear magnetic resonance imaging abnormal; Status epilepticus; Tremor; Unresponsive to stimuli; Visual disturbance	FLU3~SANOFI PASTEUR~UT2459PA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0296141	11/08/2007	FL	81.0	81		M	11/08/2007	9 Days after flu shot: confusion, lethargic, tremors, severe weakness, anorexia, irritable,dizzy, sudden dementia Hospitalized a total of 13 out of 21 days with no diagnosis CT scans ruled out stroke. Weakness,confusion, poor memory,poor balance still continue over 3 weeks after onset. Seems to have ADEM!!!   11/09/2007 Received hospital medical records which reveal patient experienced altered mental status & memory difficulty.  2 admits in 10/07: 10/18-10/20 & 10/25-10/30/2007.  11/9/07 Received additional hospital records: 10/18 admission noted to have followed progressive episode of weakness, difficulty getting up out of  chair, unsteady gait & fever.  Dx at that time w/viral illness.   CT of brain on that admission was WNL. Neuro eval done.  Had further deterioration after d/c to home. Readmitted 10/25-10/30/2007 for persistent severe weakness, right abdominal/flank pain, nausea, poor appetite, difficulty swallowing & altered mental status.  ID, Neuro & GI consult done.  No D/C summary available for any of the admits. 11/13/07 Received med records & vax records from pcp.  VAERS database updated w/same.  Office visit of 10/16/07 revealed generalized body ache x 3 days, knee pain, RUQ & right posterior chest pain & chills.  Dx w/probable viral syndrome.  Tx w/antibiotics.  Returned on 10/18 w/o improvement, weakness, LBP & HA.  Admitted to hospital for further evaluation.  Returned to office on 10/22/2007 continuing to feel weak w/shaking, epigastric pain & decreased appetite.  Referred to neuro.				Y	Y	13		Y	N	10/03/2007	10/12/2007	9	CT scan normal, unable to MRI due to pacemaker dr. refuses to preform spinal tap to check for ADEM 10/18-20/2007 Admit - only labs which reveal neutros 65.1, monos 11.7 & monos 0.80 (all slightly elevated.  PT/INR 18.5/1.61.  UA w/tr blood & 1+ protein.  BUN 27 (H).  Total bili 1.3 (H).  CK/MB neg.  CXR WNL.  CT lumbar spine revealed multilevel spinal stenosis & disc space narrowing.  DJD of facet joints & SI joints. 10/25-10/30/2007 Admit labs: CBC revealed WBC 11.4 (H), neutros 73.2 (H).  CT of abdomen/pelvis revealed renal cysts.  US RUQ was WNL.  Lipase 337 (H).  Total bili 1.6. Total CK 8 (L).  Urine & blood c/s neg.  Hepatobiliary scan WNL.  EGD done 10/29 revealed gastritis, hiatal hernia & possible Barrett's esophagus.   LABS: neutros 73.7% (H), BUN 24 (H), total bilirubin 1.3 (H), UGI w/small bowel series revealed GERD.  CXR WNL.  CT of brain WNL.	UNK	UNK	3-4 mg Coumadin daily	NONE Excellent mind and body behaved like a man 20 years younger, clear sharp mind	PMH: atherosclerotic heart dx; pacemaker 2005); long term anticoagulation therapy for atrial fibrillation.			1						1	Anorexia; Asthenia; Balance disorder; Computerised tomogram normal; Confusional state; Dementia; Dizziness; Irritability; Lethargy; Leukoencephalomyelitis; Memory impairment; Tremor	FLUX~UNKNOWN MANUFACTURER~80433~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0296144	11/08/2007	MT	66.0	66		F	11/02/2007	Phone call 11/1/07 from pt. to report left arm swollen from shot site to elbow over entire top of upper arm, stiff and painful, some redness noted. Noticed at 3:00 am, Now better by 4:30 pm - less swelling, redness and pain now. Will notify MD if no improvement or worse.									Y	10/31/2007	11/01/2007	1		PUB	PVT	UNKNOWN	None Stated	None Stated			1						1	Injection site erythema; Injection site pain; Injection site swelling; Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79717~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0962U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296147	11/08/2007	WA	5.0	5		F	11/07/2007	3 inch diameter area of erythema, warmth, itching. at site of injection. Localized inflammatory reaction vs possible cellulitis. Prescription given for Benadryl and Keflex. Reaction present on right thigh only									U	11/06/2007	11/07/2007	1	None	PVT	UNK		None	None			1						1	Injection site cellulitis; Injection site erythema; Injection site inflammation; Injection site pruritus; Injection site warmth; Local reaction	FLU3~SANOFI PASTEUR~U2439AA~6~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1343U~2~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0295122	11/09/2007	TX	9.0	9		M	11/06/2007	Initial report received from a health care professional on 24 October 2007. A nine-year-old male received a first intramuscular left deltoid injection of Fluzone SV 2007-2008 (Lot number U2528AA) and a left deltoid injection of Varivax (manufacturer Merck, Lot number 1330U, route of administration not reported) on 23 October 2007 and within 25 minutes he experienced eye and facial swelling, difficulty breathing, wheezing breath sounds on auscultation, increased blood pressure and facial flushing. The patient received treatment with 75 milligrams of intramuscular Benadryl, intramuscular epinephrine and intravenous normal saline solution. The patient was transported to hospital 60 minutes post episode in stabilized condition. Final outcome was not reported. No additional information was provided at the time of this report. The reporter of this case is the same as for case 2007-03586, which involves hives following receipt of Fluzone, lot number U2528AA.					Y				U	10/23/2007	10/23/2007	0	None	UNK	UNK			The patient had no illness at the time of vaccination. The patient's parent denied any pre-existing allergies. The patient had not received any other vaccinations within four weeks prior to 23 October 2007. The reporter was not aware of any other medications being taken by the patient.		200703587	1						2	Blood pressure; Blood pressure decreased; Swelling face; Urticaria; Wheezing; Blood pressure increased; Breath sounds; Dyspnoea; Eye swelling; Flushing; Swelling face; Wheezing	FLU3~SANOFI PASTEUR~U2528AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1330U~2~SC~LA~VARICELLA (VARIVAX)~1|FLU3~SANOFI PASTEUR~U2528AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|VARCEL~MERCK & CO. INC.~1330U~UNK~SC~LA~VARICELLA (VARIVAX)~2	USA	Hospitalisation	Influenza
0295520	11/09/2007	WI	2.0	2	.9	M	11/06/2007	significant localized swelling of right thigh. Swelling of thigh was twice normal size with associated pruritis										11/03/2007				PVT	PVT						1						2	Erythema; Injection site swelling; Rash macular; Injection site swelling; Pruritus	FLU3~SANOFI PASTEUR~U2499AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2499AA~4~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0296142	11/09/2007	HI	25.0	25		F	11/09/2007	vomiting									Y	11/09/2007	11/09/2007	0		PUB	UNK						1						1	Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296162	11/09/2007	NY	59.0	59		F	11/09/2007	15 minutes after vaccination began to feel ill with nausea and dizzyness.  five to six hours after vaccination had fever and chills.  Noted right periorbital swelling, difficulty opening right eye, headache, tingling of right lip and chin area as well as fatigue and diarrhea the following day so she visited the emergency department of the hospital.  Presumptive diagnosis of possible Bell's Palsy made and started on treatment with Valtrex and oral steroids by ED physician.  Seen by me in the office 11-05-07 for further evaluation.  I did not agree with Bell's Palsy diagnosis and entertained possible Trigeminal neuropathy and referred patient to neurologist.  Neurology visit on 11-07-07.  Dr. ordered MRI of brain which was negative and patient improving over course of this week.  According to neurologist, probable self-resolving neuropathy from vaccine???  11/13/07 Reviewed hospital ER medical records which reveal patient experienced right eye drooping, blurred vision right eye, right cheek numbness, right upper lip numbness on 11/3/07.  Tx w/antiviral & steroids. FINAL DX: Bell's palsy, right side.				Y					Y	11/02/2007	11/02/2007	0	as per above - MRI of brain negative per neurologist	UNK	UNK	none known	Accordig to patient she felt fine prior to the flu vaccination	none known	denied~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Chills; Diarrhoea; Dizziness; Eye swelling; Fatigue; Headache; Immunisation reaction; Malaise; Nausea; Neuropathy; Nuclear magnetic resonance imaging brain normal; Paraesthesia oral; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80070~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0296163	11/09/2007	GA	65.0	65		F	11/09/2007	client called 11/08/2007 2:30pm to report reddeness from site of injection striking down arm and arm swollen and hard to use. Spoke to pt on 11/09/07, states seeing Dr on 11/08/07 at 4:00pm. Pt states MD said pt may have had allergic reaction on LA. Pt also told MD about numbing sensation on RA, pt states MD said pt may have pressure on nerve causing numbing sensation on RA. Pt states this is first time having this type of reaction after a vaccine. Pt states MD prescribe pain medication, states being able to sleep on arm and move without difficulty.				Y					Y	11/05/2007	11/08/2007	3	n/a	UNK	UNK	N/A	N/A	N/A			1						1	Hypoaesthesia; Injected limb mobility decreased; Injection site erythema; Injection site streaking; Oedema peripheral	FLU3~SANOFI PASTEUR~U2507AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296164	11/09/2007	NC	8.0	8		M	11/09/2007	PATIENT CAME TO OFFICE ON 10/31/02007, HAD RECEIVED VACCINES ON 10/29/07. LEFT THIGH SWOLLEN, RED, HOT AND PAINFUL TO TOUCH. (NURSE WAS GOING TO GIVE INJECTIONS IN ARMS, BUT PATIENT PREFERRED LEGS). MD NOTED AREA OF ERYTHEMA, WARMTH, AND TENDERNESS ON LEFT THIGH, ALSO STATES PT REACTED TO BANDAID. DXED WITH CELLULITIS AND PLACED ON SEPTRA X7 DAYS.				Y					U	10/29/2007	10/30/2007	1	NONE	PVT	PUB	AUGMENTIN ES, NASONEX	PT WAS SEEN 10/29/07 FOR CONGESTION, HA, WAS AFEBRILE. DXED WITH SINUS INFECTION AND RXED AUGMENTIN ES AND NASONEX.	NONE			1						1	Cellulitis; Erythema; Injection site erythema; Injection site pain; Injection site warmth; Oedema peripheral; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80063~5~IM~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB217BA~1~IM~LL~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1178U~2~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0296166	11/09/2007	MA	62.0	62		F	11/09/2007	received flu shot on 11/1.  Saturday 11/3 began developing a hive-like rash on abdomen which increased in intensity through Thursday 11/8 covering entire torso and arms. Was taking benadryl OTC dose.   Notified PMD on 11/8 and was put on Bendadry 50mg po q6hrs and topical cortisone cream.  On 11/9 felt that symptoms were under control at least not progressing.									Y	11/01/2007	11/03/2007	2	Patient reports has diagnosis of peripheral neuropathy and has allergies to Sulf and Pennicillan.  Aso reported had a cold prior to flu shot and was taking OTC cold medication, but has taken this before without reaction	UNK	UNK	OTC cold med  and medication for peripheral neuropathy prescribed by PMD	stated had a cold, no fever	Peripheral neuropathy  allergies to Penn and Sulf			1						1	Neuropathy peripheral; Rash; Urticaria	FLU3~SANOFI PASTEUR~2505AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296167	11/09/2007	NJ	9.0	9		M	11/09/2007	Meningitis vaccine(Menactra) was given to this 9 yr. 11 mon. old child in error. Should be given starting at 11yrs of age. I spoke with the father on 11/9/07 who stated his son had no ill effects from the 5 shots he received 4 days ago.									Y	11/05/2007				UNK	UNK		None	No allergies. No medical conditions.			1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U2502AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0672R~3~IM~LA~HEP B (RECOMBIVAX HB)~1|IPV~SANOFI PASTEUR~Z0326-2~3~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MNQ~SANOFI PASTEUR~U2404AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TD~MASS. PUB HLTH BIOL LAB~Td-160~2~IM~RA~TD ADSORBED (TDVAX)~1	USA		Influenza
0296168	11/09/2007	NE	51.0	51		F	11/09/2007	Received vaccine at 8:00 am on Monday, October 29. Normal work day, went home worked in the yard, went in to view TV from 7-9:30 pm.  While reclining on couch, left arm became extremely sore at shoulder blade joint. Pain worsened by 10:30 pm was unable to move arm without excruciating pain.  Pain was in should, elbow, and wrist area. Awoke husband at 12:00 am, Tuesday, Oct. 30th and had him take to hospital ER.  It was felt that patient was having a heart attack.  Around 1:00 am administered 2 baby asprin and 3 nitro. Pain subsided almost immediately.  Patient was placed in CDU (Critical Decision Unit) for observation.  4/5 EKG's were administered and blood drawen at 3 different times checking for enzyme levels.  EKG's normal, and blood draw indicated no enzymes.  Physician on duty Tuesday morning, felt symptoms were reaction to vaccination, previous morning.  Patient was released after 16 hr observation, at 4:00 pm on Tuesday, Oct. 30.  Next morning, Wed. Oct. 31, patient experienced pain in left ear.  Patient went to see family physician as instructed by ER.  Dr. indicated that he felt the episode was due to the vaccine.  No infection was evident in the ear drum and Dr. gave patient Nasonex to unclog the ear canal. Stress test was no taken.				Y					Y	10/29/2007	10/29/2007	0	EKG's and Blood draws.	UNK	UNK	Zertec and generic decongestant	N/A	seasonal allergies, dirt.			1						1	Blood test; Ear pain; Electrocardiogram; Immunisation reaction; Injected limb mobility decreased; Musculoskeletal pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0296169	11/09/2007	OK	52.0	52		M	11/09/2007	Severe shoulder pain.  Treatment prescribed by physician includes rest, moist heat and narcotics.  Treatment initiated by patient includes antiinflammatories and rest.   Symptoms are now in their fourth week and have gotten progressively better.  Personal physician believes the vaccine was injected into the joint space of the shoulder rather than the deltoid and recommends return visit for further testing if condition persists.				Y						10/17/2007	10/17/2007	0		UNK	PVT	Naporxyn sodium, advair inhaler, albuterol inhaler.	Asthma, herniated discs	Asthma, herniated discs			1						1	Musculoskeletal pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA307DA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296170	11/09/2007	NY	83.0	83		F	11/09/2007	Face flushed for the first two days, then severe red itchy rash on arms, thighs and knees and under breasts and sides of stomach.									U	11/06/2007	11/06/2007	0	not known	PUB	UNK	none within six months of the vaccination though did take fosomax 6 months prior to that	none. Was getting a check up for heart pains.I can't submit without filling out manufacturer but we don't know who that is. I will pick one at random.	none			1						1	Flushing; Rash erythematous; Rash pruritic	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296171	11/09/2007	MO	47.0	47		F	11/09/2007	arm very sore - unable to lift arm. Doctor said infection - fever 100 to 102, chills, severe aching, light headed, heart racing, arm very red all over upper arm.				Y					N	11/05/2007	11/05/2007	0		UNK	PVT	None	None	None			1						1	Chills; Dizziness; Erythema; Infection; Injected limb mobility decreased; Pain; Pain in extremity; Palpitations; Pyrexia	FLU3~SANOFI PASTEUR~02488AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0963U~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0296172	11/09/2007	MO	59.0	59		F	11/09/2007	Two days after the shot I was so fatigued I had to go to bed. With rest I was some better the next day. I had labored breathing at times and my heart raced for no reason over a period of a week. I had to take naps and I am still fatigued. I kept wondering what was wrong with me and I remembered I received the flu shot and looked at the pink paper they gave me. I just felt that I should report this in as much as it might be important. I have not had a reaction to a flu shot before and I have had several. I will report this to my doctor too. Rest seemed to be the key to my feeling better for a few hours at a time. I didn't take my temperature, however I think I had one the two days after the shot. You may think this is not bad enough to file a report, however, I feel you should know for data purposes.									U	10/31/2007	11/02/2007	2		PUB	PVT	none	none	bactrim, codine			1						1	Dyspnoea; Fatigue; No reaction on previous exposure to drug; Palpitations	FLUX~UNKNOWN MANUFACTURER~~5~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296173	11/09/2007	MO	48.0	48		F	11/09/2007	Diarreha, abdominal cramping									Y	11/05/2007	11/06/2007	1		UNK	UNK						1						1	Abdominal pain; Diarrhoea	FLU3~SANOFI PASTEUR~0288AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0963U~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296174	11/09/2007	AZ	24.0	24		F	11/09/2007	Fever, body ache, chills.  I received the flu shot at 10:00 AM and the fever began at 9:30 PM.									Y	11/08/2007	11/08/2007	0		PUB	PVT	Ortho tri-cyclen		asthma			1						1	Chills; Pain; Pyrexia	FLU3~CSL LIMITED~~UNK~~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0296175	11/09/2007	MI	4.0	4		M	11/09/2007	Left upper arm red and swollen no other symptoms									Y	11/02/2007	11/02/2007	0	NA	PVT	PVT		none				1						1	Erythema; Oedema peripheral	DTAP~SANOFI PASTEUR~C2749BA~UNK~ID~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2500AA~UNK~ID~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0923~UNK~ID~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1031F~UNK~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0296178	11/09/2007	MI	4.0	4		F	11/09/2007	Local reaction silver dollar sz, severe Headache, vomiting , temp >101.1 , loss of appetite									Y	11/06/2007	11/07/2007	1	none	PVT	PVT		runny nose	Asthma			1						1	Anorexia; Headache; Local reaction; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2500AA~4~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296179	11/09/2007	MI	50.0			M	11/09/2007	Chest and throat irritation, breathing difficulty. Also eye irritation and swelling. Headache.									Y	11/06/2007	11/06/2007	0		UNK	PVT		None	None			1						1	Chest discomfort; Dyspnoea; Eye irritation; Eye swelling; Headache; Throat irritation	FLU3~SANOFI PASTEUR~U24C(?)7AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296180	11/09/2007	IL	49.0	49		F	11/09/2007	ITCHING AND HIVES ALL OVER BODY. TREATED BY DR WITH PREDNISONE AND BENADRYL.				Y					Y	11/01/2007	11/01/2007	0	NONE	PUB	PVT	NONE	NONE	NONE			1						1	Pruritus generalised; Urticaria	FLU3~SANOFI PASTEUR~U2499AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296181	11/09/2007	RI	66.0	66		F	11/09/2007	Pt. reports feeling ill in the evening of receiving the immunization - temp. 102.5. Next day arm was painful, red, swollen.  Seen by MD with dx. of cellulitis. Tx with Augmentin 875mg. BID X 10 days.  Both shots given in same arm per patient request.				Y					Y	10/27/2007	10/27/2007	0		PUB	PUB		Pt. reports not being ill at time of vaccination.				1						1	Cellulitis; Erythema; Malaise; Oedema peripheral; Pain in extremity; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~42491AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1005F~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0296182	11/09/2007	KY	75.0	75		F	11/09/2007	Patient contacted pharmacy on 11-9-07 and stated that left arm had been hurting since the day she received vaccine (10-19-07). She said there was no redness or fever, however, she described difficulty and pain moving her arm/shoulder. The pharmacist on duty advised her to seek immediate medical attention. Patient stated she would contact her physician.				Y					U	10/19/2007	10/19/2007	0		UNK	UNK	Unknown	None	Unknown			1						1	Injected limb mobility decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA303AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296183	11/09/2007	NC	38.0	38		F	11/09/2007	4 hours after the shot I became dizzy and very tired.  An hour later I had a fever of 99.7 and my body ached like I had the flu.  I rested through the night and became better.  My body still aches.									N	11/08/2007	11/08/2007	0		PUB	PVT		Cold with swollen glands	Latex, food allergies, peanuts, outdoor and indoor allergies.			1						1	Dizziness; Fatigue; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296199	11/09/2007	PA	4.0	4		M	11/09/2007	This case was reported by a physician and described the occurrence of hearing loss in a 4-year-old male subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On 5 November 2007 the subject inadvertently received a dose of Fluarix at 0.5 ml in the left arm. This was considered to be a medication error as Fluarix is not indicated for use in pediatric subjects. On 7 November 2007, 2 days after vaccination with Fluarix, the subject experienced possible hearing loss or reduction and crackling sounds in ear. This was considered to be medically serious by GSK. At the time of reporting the events were resolved. The physician considered the events were possibly related to vaccination with Fluarix.									Y	11/05/2007	11/07/2007	2	UNK	PVT	PVT		unknown	The subject has a history of otitis media and was seen previously on October 17, 2007.		A0693633A	1						1	Deafness; Inappropriate schedule of drug administration; Medication error; Tinnitus; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLAA056AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296200	11/09/2007	NC	31.0	31		F	11/09/2007	This case was reported by a pharmacist and described the occurrence of arm numbness in a 31-year-old female subject who was vaccinated with Fluarix for prophylaxis. On 5 November 2007 at 12:30 the subject received unspecified dose of Fluarix at 0.5 ml in the left arm. On 5 November 2007, 1 hour after vaccination with Fluarix, the subject experienced arm numbness. The pharmacist considered the event was clinically significant (or requiring intervention). At the time of reporting the event was unresolved.									N	11/05/2007	11/05/2007	0	UNK	OTH	PVT		Unknown	The subject has previously received flu shots.		A0693639A	1						1	Hypoaesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA298BA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296201	11/09/2007	CA				F	11/09/2007	This case was reported by a healthcare professional and described the occurrence of possible cellulitis in an adult female subject who was vaccinated with (Flulaval, GlaxoSmithKline) for prophylaxis. On 1 November 2007, in the late afternoon, the subject received a dose of Flulaval at 0.5 ml in the left arm. At an unspecified time after vaccination with Flulaval, the subject experienced injection site redness, injection site inflammation, injection site pain and injection site soreness. The reporter was concerned that these events might be progressing into cellulitis since they had not resolved or improved. This case was assessed as medically serious by GSK. At the time of reporting the events were unresolved.									N	11/01/2007			UNK	PUB	PUB		Unknown			A0693646A	1						1	Cellulitis; Injection site erythema; Injection site inflammation; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA066AA~1~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0296231	11/09/2007	CA	25.0	25		M	11/06/2007	A 25-year-old patient, with no reported concurrent illnesses, pre-existing medical conditions, or use of other medications, had received a left deltoid (route not provided) dose of Adacel (lot number C2758AA), and a dose (route not provided) of FluMist (manufacturer MedImmune) (lot number 500486P) on 17 October 2007. Fifteen days post-vaccinations, on 01 November 2007, the patient expired in his sleep. At the time of the report, the autopsy was not complete. No cause of death has been determined at this time.  12/14/07 Received vax record from provider which confirms lot #s as reported.  1/18/08 Reviewed autopsy report which states COD as idiopathic mitral prolapse.  Findings at autopsy included: enlarged dilated heart w/LVH & clean coronaries; parachute deformity w/hooding of anterior mitral cusp & lengthening of the chordae tendineae w/mild white thickening of the septal endocardim behind mitral valve; hyperinflated lungs; pneumomediastinum; enlarged liver/spleen/hepatic portal lymph nodes.	Y	11/01/2007							N	10/17/2007	11/01/2007	15		PVT	OTH			None		200703735	1						1	Death	FLUN3~MEDIMMUNE VACCINES, INC.~500486P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TDAP~SANOFI PASTEUR~C2758AA~UNK~UN~LA~TDAP (ADACEL)~1	USA	Results in Death	Influenza
0296232	11/09/2007	NY	56.0	56		M	11/06/2007	A 56-year-old male patient with a history of elevated cholesterol and a herniated disc received an intramuscular left deltoid injection of Fluzone (lot number U2524AA) on 22 October 2007. Approximately three hours post-vaccination, the patient began experiencing flu-like symptoms, including generalized body aches, nausea, and vomiting. The following day, he experienced a syncopal episode resulting in a fractured nose and chipped front tooth. He was seen in the emergency room, where he underwent an EKG, CBC, SMA7, C-spine, and Zocor, Lipitor, and Lopid. At the time of the report, the patient had not yet recovered.				Y					N	10/22/2007	10/23/2007	1		PVT	PVT	ZOCOR, LIPITOR, LOPID, INTRAVENOUS FLUIDS		Elevated cholesterol, herniated disc.		200703668	1						1	Electrocardiogram; Facial bones fracture; Full blood count; Influenza like illness; Laboratory test; Nausea; Pain; Spinal X-ray; Syncope; Tooth injury; Vomiting	FLU3~SANOFI PASTEUR~U2524AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296234	11/09/2007	WI	72.0	72		F	11/02/2007	(1) local swelling  (2) dizzy presyncope (3) nausea and vomiting.  12/14/07 Reviewed hospital medical records which reveal patient experienced recurrent hypotension & syncopal episodes.  Admitted 10/23-10/24/2007.  Later on day of vax, patient became pale, dizzy, fever, nauseated & had worsening injected right arm pain.  FINAL DX: reaction to pneumococcal vaccine and presyncopal episode, likely related to pneumococcal vax reaction w/presumed vasovagal episode.					Y	2			Y	10/23/2007	10/23/2007	0	CK 181; Troponin - normal; Myoglobin 167.7 LABS: EKG WNL.  Echocardiogram w/mild left atrial enlargment, mitral insufficiency & tricuspid insufficiency.  Myoglobin 167 (H), CPK 181 (H).  CXR WNL. WBC 11.5 (H), lymphs 12.2% (L), neutros 9.2 (H).	PVT	PVT	Lipitor	None	None; Hyperlipidemia PMH: hypotension, elevated cholesterol.  Pneumococcal vax in 2000.			1						1	Blood creatine phosphokinase increased; Dizziness; Local swelling; Myoglobin blood increased; Nausea; Presyncope; Swelling; Troponin; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80684~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1344u~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0296237	11/09/2007	OR	5.0	5		F	11/05/2007	Patient Received vaccines as indicated below. The Follow Evening mom Report left arm (Deltoid area Red 3 in x 3.5 in, slightly Raised, warm to touch and puritis. To ER per father. Recommended Tylenol and Ice mom complied and Began to resolve by Sunday Evening				Y					Y	11/02/2007	11/03/2007	1		PVT	PVT	Tylenol Later in The Same Day	NONE	allergic Rhinitis cause unspecified	None documented~ ()~~0.00~In Patient|None documented~ ()~~0.00~In Sibling		1						1	Erythema; Oedema peripheral; Pruritus; Skin warm	DTAP~SANOFI PASTEUR~C2749AA~5~IM~RA~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500480P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~MERCK & CO. INC.~0495U~2~IM~LA~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~A0169~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1323F~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1356U~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0296239	11/09/2007	MT	45.0	45		M	10/24/2007	local reaction at injection site, lump immediately after withdrawl needle with bruising - 5-10 min after patient complained of dizziness, sweating, and seeing spots - lasted 20-30 minutes with Nausea, paleness gave 20mg Depo-medrol IM at 10:45				Y						10/24/2007	10/24/2007	0		PUB	OTH		Fatigue, diarrhea	Codeine, Compazine, Lisinopril, Hydrocodone, Ultram			1						1	Dizziness; Hyperhidrosis; Injection site bruising; Injection site mass; Injection site reaction; Local reaction; Nausea; Pallor; Visual disturbance	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78991~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0296240	11/09/2007	MI	94.0	94		F	11/06/2007	Unknown 11/16/07 Reviewed death certificate which reveals COD as liver cancer.	Y	10/06/2007							N	10/03/2007	10/06/2007	3	None	OTH	PVT	Unknown	Unknown	Unknown			1						1	Death	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79489~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0296242	11/09/2007	MT	73.0	73		F	11/09/2007	pain, swelling at injection site site (Pneumovax) Redness. itching and report of hives  11-9-07 at 6:30pm				Y					U	11/09/2007	11/09/2007	0		OTH	PUB		Cough	None Listed			1						1	Erythema; Injection site pain; Injection site swelling; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2493AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0963U~2~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0296243	11/09/2007	OR	0.2	0	.2	F	10/22/2007	infant given Fluzone 0.25mg IM which is not indicated for her age. So far no reported adverse reactions. This was given in error									Y	10/15/2007				PVT	PVT		None	none			1						1	Inappropriate schedule of drug administration; Wrong drug administered	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B128AB~1~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2441AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF188AA~1~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~~1~UN~UN~PNEUMO (PREVNAR)~1	USA		Influenza
0296244	11/09/2007	AZ	7.0	7		M	11/02/2007	Cellulitis around site of injection - Started on Clindamycin										10/30/2007	10/30/2007	0		PVT	PUB		None				1						1	Injection site cellulitis	FLU3~SANOFI PASTEUR~V2490AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1031V~UNK~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0296245	11/09/2007	CA	36.0	36		F	11/09/2007	After receiving influenza vaccination patient felt dizzy and had to sit down. Patient was very nervous about getting shot and had not eaten any food that morning or had anything to drink. Vaccination site was not swollen or red and respiration was normal and B/P 84/50. Client was given juice and crackers to eat and felt better									Y	11/09/2007	11/09/2007	0	NONE;Checked patient's blood pressure again at 11 AM was 108/05. Pulse 80. Paties was feeling good. Instructed patient to let private physician know about problem with dizziness	PUB	PVT		NONE	Unknown			1						1	Dizziness; Nervousness	FLU3~SANOFI PASTEUR~U2509AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296246	11/09/2007	MN	12.0	12		F	11/06/2007	None									U	11/05/2007				PUB	PVT	NONE	NONE	NONE			1						1	No adverse reaction; Unevaluable event	DTAP~SANOFI PASTEUR~C2749AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2506AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1076U~3~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0296247	11/09/2007	MD	1.0	1	.0	F	11/09/2007	MMR/VARIVAX/HEPA/influenza given 10/23/07; Fever to 103 on 10/31/07 - 11/3/07; Rash on 11/4/07									Y	10/23/2007	10/31/2007	8	None	PVT	PVT	None	None	None			1						1	Pyrexia; Rash	FLU3~SANOFI PASTEUR~U24606AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1259U~1~IM~LL~HEP A (VAQTA)~1|MMR~MERCK & CO. INC.~0749U~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1095U~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0296248	11/09/2007	CO	14.0	14		M	11/05/2007	patient Looked pale approximately 10min after flu shot - Pharmacist gave him 25mg Diphenhydramine - Paramedics came - After taking has BP and pulse after interviewing him they decided it was a delayed anxiety.									Y	11/01/2007	11/01/2007	0		OTH	PVT		None				1						1	Anxiety; Pallor	FLU3~SANOFI PASTEUR~U2488AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296250	11/09/2007	CA	64.0	64		M	11/10/2007	110907-Pain/Level 05/left eye socket To Back of Head Discomfort his left side of Body/Dizziness/More loss of BU of left side of Body; 111007 - Headache and Body Soreness									U	11/08/2007	11/09/2007	1		OTH	PVT						1						1	Discomfort; Dizziness; Eye pain; Headache; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296252	11/09/2007	WA	5.0	5		F		Chicken Pox Shot given 11/8/07 presented today 11/9/07 with 2cm x 2.5cm indurated increased warmth at site									U	11/08/2007	11/09/2007	1		PUB	UNK		None				1						1	Injection site induration; Injection site warmth	FLU3~SANOFI PASTEUR~U2490AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0296254	11/09/2007	OR	21.0	21		F	11/03/2007	Within 5 minutes of receiving Flumist patient began c/o feeling hot and lightheaded. Member vs. were stable. No c/o tightness in chest or problems breathing. Rested, complaints resolved within 15 minutes.									Y	11/03/2007	11/03/2007	0	None	MIL	MIL		None	None			1						1	Dizziness; Feeling hot; Immediate post-injection reaction	FLUN3~MEDIMMUNE VACCINES, INC.~500496P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0296256	11/09/2007	WI	65.0	65		F	10/16/2007	high fever, red swollen arm lasting 24-48 hrs. treated with Amoxicillin and Ibuprofen				Y					Y	10/10/2007	10/11/2007	1	ultrasound negative	OTH	PUB		None	None			1						1	Erythema; Oedema peripheral; Pyrexia; Ultrasound scan normal	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0296257	11/09/2007	NJ	69.0	69		M	11/09/2007	Fever, chills, headache, stomach upset, soreness on right arm. This lasted for entire next day and night following the injection.									Y	11/07/2007	11/08/2007	1		PUB	PUB		None	None			1						1	Chills; Headache; Pain in extremity; Pyrexia; Stomach discomfort	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0296259	11/09/2007	MT	14.0	14		F	11/09/2007	Fainted, pt. was layed down and given something to eat.									Y	11/09/2007	11/09/2007	0	None	PVT	OTH	Adderall XR	None				1						1	Syncope	FLU3~SANOFI PASTEUR~12664~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~U2531AA~1~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0296260	11/09/2007	NE	84.0	84		F	11/06/2007	By next am after injection reddened and warm to touch with increased swelling and discomfort distal and inferior to injection site (inner aspect of upper arm) reddened. Public health nurse called Dr. office and was seen immediately (within 24 hr of immunization). Put on steroids and Zyrtec. To be seen again on 11/1/07-At that visit-area improving.				Y					Y	10/30/2007	10/31/2007	1		PUB	PVT	Lasix, Zocor, Calcium, Norvac, Monopol, Toprol, Cod Liver oil, Advair, Baby ASA, Vit B6, B12, C	None	hx of asthma, pacemaker			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2450AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1132U~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0296264	11/09/2007	CO	10.0	10		M	11/01/2007	Pt given Zostavax inadvertently in place of Varicella. Pt. parents notified immediately. No reaction founded									Y	10/31/2007				PUB	UNK		None	PCN			1						1	Inappropriate schedule of drug administration; Wrong drug administered	FLU3~SANOFI PASTEUR~U2443AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB186C~1~IM~RA~HEP A (HAVRIX)~1|VARZOS~MERCK & CO. INC.~0761U~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0296265	11/09/2007	MA	54.0	54		F	11/09/2007	2 x 3 red, warm, painful area on (L) upper arm.									U	11/07/2007	11/07/2007	0		PUB	PUB	None	None	Allergic to mold/cats-had reaction in past to pneumonia vaccine	red, pain, chills~Pneumo (no brand name)~1~0.00~In Patient		1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA050AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0296266	11/09/2007	CO				M	11/01/2007	Pt inadvertently given Zoster vaccine in place of Varicella vac. no reaction found parents notified									Y	10/31/2007				UNK	UNK						1						1	Inappropriate schedule of drug administration; Wrong drug administered	FLU3~SANOFI PASTEUR~U2443AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB186CA~1~IM~LA~HEP A (HAVRIX)~1|VARZOS~MERCK & CO. INC.~0761U~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0296267	11/09/2007	MA	33.0	33		M	11/09/2007	2 x 1 1/2 red, warm, tender area in (L) upper arm with sm-blister at center-within 18 hours blister resolved.									Y	11/07/2007	11/08/2007	1		PUB	PUB	None	None	environmental allergies			1						1	Injection site erythema; Injection site pain; Injection site vesicles; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA050AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0296268	11/09/2007	PA	0.51	0	.5	M	11/08/2007	Mother reported to Dr via phone call that child had non stoppable crying for 24 hours. Treated with Tylenol-Advised Motrin for the night									Y	11/05/2007	11/05/2007	0	None	PVT	PVT		None	None			1						1	Crying	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B056CA~3~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2477FA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF214AB~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B539818~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0296269	11/09/2007	PA	3.0	3		M	11/09/2007	Thrashing, screaming, unconsolable. Child states he saw crawly things on wall. Mom stated he seemed awake. -Has never done this before.									Y	11/06/2007	11/07/2007	1	None	PVT	PVT	Luride 0.5 mg daily	None	Pre-maturity			1						1	Aggression; Emotional distress; Hallucination; Screaming	FLU3~SANOFI PASTEUR~U2501AA~5~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296270	11/09/2007	WI	63.0	63		M	11/09/2007	c/o Spinning sensation in head-no other symptoms. Radial pulse 86 and regular B/P 142/82. No change in symptom x 45 min. Instructed by RN to go to ER if symptom worsened or new symptoms (SOB, wheezing dizziness, weakness swollen throat) developed. Refused to go to ER at time of event. Checked (15m x 4'5m 11-8-07-TC: spinnin symptom resolved at 10pm on 11-7-07 feels fine today.									Y	11/07/2007	11/07/2007	0		OTH	UNK	Lisinopril, HCTZ	None	HTN			1						1	Vertigo	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA030AA~1~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0296271	11/09/2007	TX	2.0	2	.8	M	11/08/2007	Fever: range 100.2 to 103.5 starting on 11/2/07 thru 11/4/07. Motrin and Tylenol given. Hives: 11/3 - 11/4/07. Benadryl given. Once seen by RN/NP, Atarax syrup and hydrocortisone prescriptions given. Sore throat: 11/2/07. Rocephin shot given on 11/3/07 by RN. Azithromycin prescription given by NP.				Y					Y	11/01/2007	11/02/2007	1	Unknown	PVT	OTH		None	Seasonal allergies (trees and dust mites); Reactive airway disease			1						1	Pharyngolaryngeal pain; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~UT2456EA~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296272	11/09/2007	OH	35.0	35		F	11/06/2007	relates tightness in chest approximately 4 hours after injection-relieved by po Benadryl. Symptoms returned x 2 in next 20 hrs both times relieved by po Benadryl.									Y	11/02/2007	11/02/2007	0		PUB	UNK	Unknown		Cat dander; sometimes indigestion with eggs			1						1	Chest discomfort	FLU3~SANOFI PASTEUR~U2501AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296273	11/09/2007	MT	6.0	6		M	11/02/2007	10 x 12 cm area of redness and induration with 2 cm area of superficial blistering centered on Varivax injection site (Left arm)				Y						10/31/2007	11/01/2007	1	None	PVT	PVT	None	None	None			1						1	Injection site erythema; Injection site induration; Injection site vesicles	FLU3~SANOFI PASTEUR~U2530AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~10024~2~UN~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0296274	11/09/2007	NY	44.0	44		F	11/05/2007	Hives, swollen arm, heat around area and pain in arm, veins along left side of chest very visible, not visible along side where flu vacc. was given, severe diarrhea - no severe effects from flu vaccination - no treatment from clinic. I used Arnica rub - helped.									Y	10/30/2007	10/31/2007	1		PUB	OTH	Lexapro	None	No			1						1	Diarrhoea; Oedema peripheral; Pain in extremity; Skin warm; Urticaria	FLUX~UNKNOWN MANUFACTURER~80070~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0200U~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296275	11/09/2007	CT	71.0	71		F	10/31/2007	Large area of induration, erythema, tenderness, encompassing entire deltoid to elbow. pain (L) neck/ribs				Y					Y	10/30/2007	10/30/2007	0	None	PVT	PVT		None				1						1	Injection site erythema; Injection site induration; Injection site pain; Musculoskeletal chest pain; Neck pain	FLU3~SANOFI PASTEUR~U2439AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1132U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0296276	11/09/2007	MT	47.0	47		F	10/25/2007	Itchy from head to toe within 30 minutes of administration. Gave 50 mg Benadryl by mouth. No additional doses needed-Patient F/U 10/25-felt fine									Y	10/24/2007	10/24/2007	0		OTH	OTH			Latex			1						1	Pruritus generalised	FLU3~SANOFI PASTEUR~U2453AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296277	11/09/2007	NJ	74.0	74		M	10/24/2007	Blurred vision, disorientation, memory loss. Time course: from 10:45 am to 6:00 pm of day of inoculation.									Y	10/05/2007	10/05/2007	0	No relevant tests were performed.	PVT	PVT	Toprol XL, Imdur, Cozaar, Coumadin, Flomax, Vytorin 10/20, Lexapro, Proscar, Temazepam, Aspirin	None	Benign positional vertigo (diagnosed 7/26/06) Heart attack and stroke in April 1998			1						1	Amnesia; Disorientation; Vision blurred	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA307BA~4~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296278	11/09/2007	IL	53.0	53		F	11/01/2007	Body was numb and tingling within 24 hours after shot, nauseated, dizzy, shaky. Received hydrocortisone shot, Compazine.				Y					Y	10/23/2007	10/24/2007	1		OTH	PVT						1						1	Dizziness; Hypoaesthesia; Nausea; Paraesthesia; Tremor	FLU3~SANOFI PASTEUR~U2529AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296279	11/09/2007	MO	58.0	58		F	11/02/2007	On October 12, 2007, I received the Flu shot. Within one hour of receiving the shot, my arm started to hurt; as in, a pain from the shot entry down to my wrist. By that night, I knew something was wrong because I felt drained. The next morning, I was so drained that I had problems with putting my thoughts together and saying what I wanted to say. I also did feel like putting one foot in front of the other (no energy). I rested and slept most of the day on Saturday. On Sunday morning as I was getting dressed for the day, I noticed that I was broke out from the top of my head to the bottom of my feet (hives) and I had 101 degree fever. So I started taking Benadryl every four hours with little relief. I have several allergies (they are listed below) so I knew at that time I was having an allergic reaction. On Monday (October 15), I was at my doctor's office when the office opened. My blood pressure was so low that neither the nurse nor the doctor would say what the bottom number was, but the top number was 80. (I normally have high blood pressure and I didn't take my medicines before I went to the doctor.) Doctor prescribed an allergy shot and two types of medicines. My second visit to the doctor was on Wednesday (October 17) and my BP was still 100/80. I missed three days of work plus two doctor's visit and medicines. This was not my first year for receiving the flu shot. I have received the flu shot for several years with the exception of the year when the shot was not available.				Y					Y	10/12/2007	10/12/2007	0		OTH	OTH	Zestoretic; Zyloprim	None	I am allergic to Penicillin, Duricef, Vibramycin, Keflex, Tetracycline, and any of the e-mycins.			1						1	Arthralgia; Asthenia; Blood pressure; Bradyphrenia; Fatigue; Hypersensitivity; No reaction on previous exposure to drug; Pain in extremity; Pyrexia; Somnolence; Speech disorder; Urticaria	FLU3~SANOFI PASTEUR~U2449AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296280	11/09/2007	GA	5.0	5		M	11/05/2007	None stated									Y	10/30/2007	11/01/2007	2		PVT	PVT	Flovent	None	None			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2526AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296285	11/09/2007	WI	67.0	67		M	10/29/2007	Within 1hr of receiving Fluviron dose (0.5ml) patient reports tingling of (L) finger and itching of (L) palm. Recommended Benadryl for itching and to notify patient's physician if tingling gets worse or spreads. Injection site is sore, normal reaction.									Y	10/29/2007	10/29/2007	0	None	OTH	PVT	MVI rd Viagra otc pain med.	None	NKA			1						1	Injection site pain; Paraesthesia; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80434~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0296286	11/09/2007	TX	85.0	85		F	11/03/2007	30 hours after flu shot was administered, I broke out in rash. It went away and returned about 17 hrs later. I used ice packs and was ok.									Y	10/26/2007	10/28/2007	2		PUB	UNK		None	None			1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296288	11/09/2007	VA	22.0	22		F	11/05/2007	within 45-60 min of getting flu and meningitis vaccines, symptoms increased rapidly from nausea, to feeling hot, to heart racing and then throat closing. Went to ER where was given Steroids, Benadryl, nausea meds and fluids				Y					Y	10/29/2007	10/29/2007	0	999.4	PVT	UNK			Fatty Liver elevated LFT's, NKDA			1						1	Feeling hot; Nausea; Palpitations; Throat tightness	FLU3~SANOFI PASTEUR~U2527AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2402AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0296289	11/09/2007	TX	38.0	38		M	11/09/2007	Pt developed transverse myelitis after receiving flu shot. He is now in the ICU and receiving IVIG.  11/16/07 Received hospital medical records which corrected DOB & reveal patient experienced LLL pneumonia approx 5-7 days prior to hospitalization.  Tx w/antibiotic.  Developed increasing bilateral LE weakness & numbness beginning 11/6.  Bowel & bladder incontinent.  Admitted 11/6-11/9/2007.  LP done.  Neurology & ID consult done.  Tx w/steroids & IVIG x 3 days.  Transferred to another hospital per pt request. FINAL DX: Guillain Barre syndrome. 11/27/07 Reviewed pcp med record of 11/05/2007 when patient received IM dose of antibiotic.  11/27/07 Reviewed hospital medical records which reveal patient experienced acute onset of weakness & paresthesias of bilateral LEs, urinary retention & diarrhea.  Patient had respiratory infection approx 2 weeks prior to onset of these symptoms. Tx at outlying hospital initially where he received the IVIG & steroids. Admitted 11/10-11/15/2007 for acute care & then rehab 11/15-11/21/2007.  Upon d/c to home required use of cane & needed assist w/transfers & bathing.  Referred to outpatient PT & neuro clinic for f/u.  D/C summary requested from hospital. FINAL DX: post infectious or post vaccination transverse myelitis. 11/30/07 Reviewed d/c summary.					Y	14			U	11/05/2007	11/06/2007	1	LABS: CT of head & spine WNL.  MRI of brain & spine WNL.  CSF: RBC 50, protein 43, glucose 73, WBC 39, polys 11%, lymphs 74%, culture neg.  NCS c/w GBS.   LABS: MRI of brain & spine were WNL.  Initial SSA was (+), repeat was (-).  EMG abnormal.	UNK	UNK		Pneumonia	PMH: migraines, dyslipidemia, pneumonia			1						1	Intensive care; Myelitis transverse	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0296293	11/09/2007	TX	59.0	59		F	11/09/2007	11/09/07 1100 am Client called our office regarding a reaction to left arm from Tdap shot.  Client states 11/07/07 the next morning after the injection her arm was sore and then it started getting red and swollen.  Client stated she placed warm heat to injection site and took Benadryl this morning.  Encouraged client to see her physician for reaction.  She stated she would see how it did this weekend and go to the doctor next week if it was not better.									U	11/06/2007	11/07/2007	1		PUB	PUB	Unknown.	No.	Unknown.			1						1	Erythema; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2449AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2454AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0296294	11/09/2007	KS	33.0	33		F	11/09/2007	Morning after receipt of vaccine a red, warm area 51 mm wide by 40 mm high area developed at injection site. No systemic reaction.										11/08/2007	11/09/2007	1		PUB	PVT	None	Denies	None			1						1	Injection site erythema; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA309AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296295	11/09/2007	MO	35.0	35		F	11/09/2007	headache and sore arm									Y	11/05/2007	11/05/2007	0		UNK	PVT						1						1	Headache; Pain in extremity	FLU3~SANOFI PASTEUR~02488AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296296	11/09/2007	MO	42.0	42		F	11/09/2007	None										11/05/2007				PUB	PVT	Zocor 20 mgs	None				1						1	Unevaluable event	FLU3~SANOFI PASTEUR~02488AA~7+~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296298	11/09/2007	MO	34.0			F	11/09/2007	I was sick for four days.  I had fever of 102.  My arm was swollen where I had both of the shots.  The shots were given in the same arm.  I couldn't move my arm for 3 days without a great deal of pain.  I also became nauseous and had diahreha.									Y				Flu vaccine        Sanoti Pasteur        #02488AA  Pneumonia         Merck                      0963U	UNK	UNK		I became ill pretty immediately after I had the shots.				1						1	Diarrhoea; Injected limb mobility decreased; Malaise; Nausea; Oedema peripheral; Pyrexia	FLU3~SANOFI PASTEUR~#02488AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~#0963U~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296300	11/09/2007	MO	35.0	35		F	11/09/2007	I had a fever for about 24 hours.  Body Ache									Y	11/05/2007	11/05/2007	0		UNK	UNK						1						1	Pain; Pyrexia	FLU3~SANOFI PASTEUR~0963U~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~02488AA~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296301	11/09/2007	PA	2.0	2	.2	F	11/09/2007	fussy night after vaccine, lg temp to 100.  Next early afternoon fever to 103 and vomiting.  Increased sleepiness. Episode on-going									U	11/08/2007	11/08/2007	0	none done at this point, watching patient	PVT	PVT		none	Reactive Airways Disease,			1						1	Irritability; Pyrexia; Somnolence; Vomiting	FLU3~SANOFI PASTEUR~U2458AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296302	11/09/2007	MO	41.0	41		F	11/09/2007	I had a fever the night of the shots.  I was extremely achy and sore.  My arm was very sore for 4 days.  I could not touch or sleep on my right arm for 4 days.  The day after the shots I was very weak and nausious.									U	11/05/2007	11/05/2007	0		PUB	UNK		none	environmental allergies (mold, trees)	none~ ()~NULL~~In Patient		1						1	Asthenia; Nausea; Pain; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~02488AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~09630~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296303	11/09/2007	NY	38.0	38		M	11/09/2007	10/29 Vaccine given at work (patient is nurse on unit)- no c/o discomfort at time of injection evening following injection- increased pain at site(left deltoid)10/30increase in pain (6 on scale of 10), tingling and raised rash to left arm. 10/31 further increase in rash & pain went to PCP DX: Cellulitis given antibiotics & instructions for warm moist heat & elevation.				Y					U	10/29/2007	10/30/2007	1	Ultrasound of Left Upper extreamity today 11/9 results pending	UNK	UNK	Protonix 40 mg. po daily, Multivitamin 1 po daily	None	None			1						1	Cellulitis; Injection site pain; Paraesthesia; Rash; Ultrasound scan	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA317AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1344U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0296304	11/09/2007	GA	73.0	73		M	11/09/2007	non injection site zoster-like rash				Y					N	11/01/2007	11/03/2007	2	referred to dermatology	UNK	UNK	Lipitor, Coumadin, Zetia, Toprol XL, Protonix	diarrhea x 1 since am on day of vaccine administration	none	none~ ()~~0.00~Patient		1						1	Rash; Rash vesicular; Discomfort; Herpes zoster; Musculoskeletal pain; Pain in extremity; Rash; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81108~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARZOS~MERCK & CO. INC.~1089U~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|VARZOS~MERCK & CO. INC.~1089U~1~UN~UN~ZOSTER LIVE (ZOSTAVAX)~2	USA	Emergency room visit	Influenza
0296305	11/09/2007	NC	1.58	1	.6	M	11/09/2007	FEVER LAST NIGHT: 99 AX. THIS AM VOMITING/DIARRHEA. SLEEPING; MOM WENT TO WAKE HIM,REPORTS HIS EYES ROLLED BACK IN HEAD AND ALL EXTREMITIES SHOOK. BECAME HIMSELF IN A FEW MINUTES. TEMP. TODAY AT E.R. VISIT 97.3 AX. HX. OF E.R. VISIT 10/21/07 POSSIBLE PERF. LEFT T.M. PUT ON  ZITHROMAX.				Y					Y	11/07/2007	11/08/2007	1	LABS ORDERED, NO RESULT AVAILABLE AT THIS TIME. CBC WITH DIFF., CHEM. 7; UA; BLOOD CULTURE X1. DX. 1. ISOLATED SEIZURE ACTIVITY 2. PROBABLE ADVISE REACTION TO VACCINATION.	PUB	UNK	NONE. MOM GAVE ACETAMINOPHEN LAST NIGHT.	NO	PAST HX. O.M.			1						1	Blood culture; Convulsion; Diarrhoea; Full blood count; Gaze palsy; Immunisation reaction; Pyrexia; Sleep disorder; Tremor; Urine analysis; Vomiting	DTAP~SANOFI PASTEUR~U2289CA~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT2474AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296306	11/09/2007	OK	24.0	24		F	11/09/2007	Client received flu vaccine at approx. 08:40 AM.She called health dept. at approx 14:30 stating she was having a reaction to flu shot.  Having difficulty breathing, covered with whelps and swelling behind her ears.  States she has asthma.  Instructed to come to HD ASAp or go directly to ER if necessary.  1500 we called client and she stated she was on her way.  1515 client here and found to have large, red, raised whelps covering most of face, neck, and torso.  Did not complain of itching but a burning sensation from whelps.  Has asthma, on PRN meds.  No edema noted behind ears, no frank respiratory distress, naturally anxious.  Referred to local ED.  We did not have contact with client on Friday but it was reported to us that she was at the football game and having no problems.  Follow up on Monday  (11-05-07) found her to be doing well.  She was given meds at ER but cannot remember the name of them.  Whelps have completely subsided with no apparent residual.  She said ED physician said: it could be a reaction to the flu vaccine, I am not sure.  We talked with her on Thursday (11-08-07) and she continues to do well.				Y					Y	11/02/2007	11/02/2007	0		PUB	UNK		None	Asthma			1						1	Anxiety; Burning sensation; Dyspnoea; Immunisation reaction; Swelling face; Urticaria	FLU3~SANOFI PASTEUR~U2508AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296307	11/09/2007	CA	8.0	8		F	11/09/2007	Child received influenza vaccine at approx. 10AM on 10/17/07 and after 1 day she had redness and induration approx 3 diameter that lasted for 48 hours. No treatment was provided. At time of vaccination, the parent reported no medication intake, no allergies, and no vaccines in the prior 4 weeks.				Y					Y	10/17/2007	10/18/2007	1	None	PVT	PVT	None	None	None	Local reaction~Influenza (Seasonal) (Fluzone)~4~6.30~In Sibling1		1						1	Erythema; Induration	FLU3~SANOFI PASTEUR~U24766A~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296308	11/09/2007	CA	6.0	6		F	11/09/2007	Child received influenza vaccine at approx 10AM and after 1 day, the site was red with induration of approx. 3diameter that lasted for 48 hours. No treatment was prescribed. Child has history of allergies to amoxicillin and ceftin.				Y					Y	10/17/2007	10/18/2007	1	None	PVT	PVT	None	None	Allergy to Amoxicillin and Ceftin.	Local reaction~Influenza (Seasonal) (Fluzone)~4~8.00~In Sibling1		1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U24766A~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296309	11/09/2007	WA	64.0	64		F	11/09/2007	Night of shot- upper arm painful, tight feeling as if encircled with a band, extreme thirst, headache, sleepless.  Next day - upper arm in area of shot had a reddish rash, arm painful, very tight feeling, headache.  Second day - upper arm bright red, very hot, painful and swollen as if filled with liquid.  Third day - redness, swelling as if filled with liquid, and hot down to mid-forearm, entire arm painful.   Fourth day -  same as third day.  Fifth day - swelling and redness started to subside, upper arm still tight and painful.  By the end of a week swelling and redness subsided, upper arm still tight and tender.  Based on advice from the pharmacist I had taken Benadryl and Advil several times early in the week, did not seem to be having any effect so I quit taking them.  My right upper arm muscle still seems slightly sore, other than that I feel fine.  I had had bronchitis and a slight touch of pneumonia according to an x-ray in May of this year which prompted me to get the pneumonia shot this fall.									Y	10/17/2007	10/17/2007	0		UNK	PVT						1						1	Erythema; Headache; Insomnia; Myalgia; Oedema peripheral; Pain in extremity; Rash erythematous; Skin tightness; Thirst	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA026AA~3~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1132U ex 3/009~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296310	11/09/2007	MO	59.0	59		F	11/09/2007	Started at dinner time (5;30 PM) aches and about an hour later chills.  I didn't take my temperature.  Lasted several hours.									Y	11/05/2007	11/05/2007	0		UNK	PVT		none	none			1						1	Chills; Pain	FLU3~SANOFI PASTEUR~02488AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0963u~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296311	11/09/2007	TX	87.0	87		F	11/09/2007	PATIENT CAME IN TO SHOW ME REACTION.  INJECTION GIVEN IN LEFT DELTOID.  INSIDE AREA OF  LEFT ELBOW SWOLLEN/DISCOLORED/SMALL BLISTER.  SHE SAYS AREA WAS MUCH WORSE YESTERDAY & FEELS IT IS GETTING BETTER.  SHE IS NOT WORRIED ABOUT IT, BUT I TOLD HER TO BE SURE TO CALL HER DOCTOR IF IT WAS NOT SIGNIFICANTLY BETTER TOMORROW.  AREA IS SWOLLEN & DARK RED/BROWN IN COLOR.									U	11/06/2007	11/08/2007	2	NONE	UNK	PVT	NONE	NONE	PENICILLN ALLERGY			1						1	Blister; Injection site reaction; Joint swelling; Oedema peripheral; Skin discolouration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79238~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0803U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296313	11/09/2007	HI	4.0	4		M	11/09/2007	Deltoid muscle swelling and pain within 24 hours.  Treated with motrin and ice									Y	11/08/2007	11/09/2007	1	none	PVT	PVT		Viral URI	none			1						1	Muscle swelling; Myalgia	FLU3~SANOFI PASTEUR~U2449AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296314	11/09/2007	SC	1.0	1	.0	M	11/09/2007	fever beginning 9 days after vaccination, lasting 2 days, max of 101.8 deg F tympanic;  moderate rash covering face, trunk, arms, and legs beginning day 10 and lasting 4 days; treated w/Motrin for fever and discomfort; we did take photos of the rash for documentation									Y	10/01/2007	10/10/2007	9	n/a	PVT	UNK	none	none	R temporal lobe dyplasia r/t thromboembolism in utero;  developmental delay; prematurity			1						1	Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~1~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~IM~UN~HEP A (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~UNK~IM~UN~HIB (NO BRAND NAME)~1|MMRV~UNKNOWN MANUFACTURER~~1~IM~UN~MEASLES + MUMPS + RUBELLA + VARICELLA (NO BRAND NAME)~1	USA		Influenza
0296336	11/09/2007	NY	25.0	25		F	11/02/2007	approx. 20 min. after injection-She returned -> light bruise at injection site to Lt deltoid-Lt. hand moist, Lt. arm cold, stated fingertips numb, nailbeds dusky-full sensation and ROM, grips equal; circulation improved while resting on table-ice packs to site, escorted by friends to obtain Benadryl (50 mg, P.O./F/U call at 1300-she returned to work as symptoms subsided.									Y	10/31/2007	10/31/2007	0	None	OTH	UNK		None				1						1	Cold sweat; Cyanosis; Feeling cold; Hypoaesthesia; Injection site bruising	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA318BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296337	11/09/2007	GA	36.0	36		F	10/30/2007	Severe shortness of breath and wheezing had to use son's Albuterol inhaler. -Used one dose and then fully recovered.									Y	10/25/2007	10/25/2007	0	None	OTH	PVT		None	Seasonal allergies			1						1	Dyspnoea; Wheezing	FLU3~SANOFI PASTEUR~U2526AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296338	11/09/2007	WA	10.0	10		F	11/02/2007	Pt developed redness and swelling on the injection site immediately (2x3 cm). She spiked 102 deg fever on 11/2/07 at 8 am. She has muscle aches.									Y	10/31/2007	10/31/2007	0	None	PVT	UNK				swelling of arm~Vaccine not specified (no brand name)~2~9.00~In Patient		1						1	Injection site erythema; Injection site swelling; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U2530AA~3~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296341	11/09/2007	IA	5.0	5		M	11/05/2007	Much swelling at vaccine site at 24 hrs.-extending from anterior thigh to knee										11/03/2007	11/04/2007	1	None	PVT	PVT	None	None	None			1						1	Injection site swelling	FLU3~SANOFI PASTEUR~U2457HA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296342	11/09/2007	IA	5.0	5		M	11/05/2007	large area of induration-thigh										11/03/2007	11/04/2007	1	None	PVT	PVT	None	None	asthma			1						1	Injection site induration	FLU3~SANOFI PASTEUR~U2473AA~6~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296343	11/09/2007		22.0	22		M	10/31/2007	8 hrs s/p vaccine. Pt developed frontal headache, night sweats and subjective fever. Pt seen by PCM in am with HA, photophobia, no nuchal rigidity but pain with eye movement									U	10/30/2007	10/30/2007	0		MIL	MIL		None	None			1						1	Eye pain; Headache; Night sweats; Photophobia; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA049AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296345	11/09/2007	TX	9.0	9		M	11/05/2007	Pt developed erythema and swelling at the injection site. When seen 3 days after the immunization there was a reticular pink rash on arm and shoulder and significant arm edema.									Y	10/26/2007	10/26/2007	0		PVT	PVT		None	eats eggs. Class II RAST to egg white 1/05)			1						1	Injection site erythema; Injection site swelling; Oedema peripheral	FLU3~SANOFI PASTEUR~42489AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296347	11/09/2007	IL	65.0	65		F	11/06/2007	Fever 105 deg, chills left arm swelling 4 to 5 times and redness. Joint pain, Face swelling.									N	10/29/2007	10/29/2007	0		PUB	PVT	Restoril q pm; Soriatane 10 mg; Lidoderm 5% patch	None	psoriasis; psoriatic arthritis; anemia; pernicious			1						1	Arthralgia; Chills; Erythema; Oedema peripheral; Pyrexia; Swelling face	FLU3~SANOFI PASTEUR~U2464AA~5~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0554U~2~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296349	11/09/2007	NM	37.0	37		F	11/05/2007	Influenza vaccine reaction with erythema 10x4cm and ecchymosis.									U	10/31/2007	11/01/2007	1	None	PVT	UNK		None	TB reaction			1						1	Ecchymosis; Erythema	FLUX~UNKNOWN MANUFACTURER~AFLLA082AA~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296351	11/09/2007	SD	43.0	43		F	11/05/2007	Redness/swelling at injection site - spreading to shoulder area, neck and roof of mouth, itches.				Y					Y	10/30/2007	11/01/2007	2		PUB	UNK	Patient reports she is on Singulair daily	None	Allergies, asthma			1						1	Injection site erythema; Injection site swelling; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79719~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0296352	11/09/2007	ND	86.0	86		F	11/05/2007	Developed red hives during night. 0300 eyes itchy, itching, no throat tight, difficult to swallow, lips swollen. Prednisone 20mg PO, Benadryl 50mg, cool packs. No MD.									Y	10/31/2007	11/01/2007	1	N/A	PUB	PVT	Advair; Spiriva; Spironolactone; Glypazide	No	Chicken feathers, Strawberries, Chocolate, Asthma, COPD			1						1	Dysphagia; Erythema; Eye pruritus; Lip swelling; Urticaria	FLU3~SANOFI PASTEUR~U2499AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296353	11/09/2007	MI	64.0	64		F	10/26/2007	Nerve pain/arm, shoulder/across back.									U	10/24/2007	10/25/2007	1		OTH	UNK						1						1	Musculoskeletal pain; Neuralgia; Pain in extremity	FLU3~SANOFI PASTEUR~U2529AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296354	11/09/2007	FL	38.0	38		M	11/03/2007	Nausea, diarrhea, pain to left arm, stated had headache. Blood pressure 135/105 at 3:50 PM.				Y					Y	11/03/2007	11/03/2007	0		OTH	MIL		None noted				1						1	Blood pressure; Diarrhoea; Headache; Nausea; Pain in extremity	FLUN3~MEDIMMUNE VACCINES, INC.~500488P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TYP~SANOFI PASTEUR~LAD394~UNK~UN~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0296356	11/09/2007	HI	11.0	11		M	10/30/2007	About 90 minutes after receiving flu shot in L.D. child reported to grandfather that he could not move his (L) arm. Grandfather instructed to call PCP and left to take child to PCP.				Y					Y	10/30/2007	10/30/2007	0	N/A	OTH	UNK		None	None		HI0703	1						1	Injected limb mobility decreased	FLU3~SANOFI PASTEUR~U2461AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296357	11/09/2007	HI	53.0	53		F	11/01/2007	10:15 am - Received flu shot in left arm. No pain. 12:00pm pain in forearm. Needed to rub, = 12:30pm pain in left hand between 3 middle fingers. Couldn't sleep, throbbing pain in fingers. Took Naprosyn no relief. 11/1/07 - Took Tylenol, no relief. Throbbing pain continues in middle 3 fingers.									U	10/31/2007	10/31/2007	0		OTH	PUB	None	None	None	numbness in thumb and index finger after receiving Flu shot went away in 2 days~Vaccine not specified (no brand name)~UN~0.00~In	HI0704	1						1	Pain; Pain in extremity; Sleep disorder	FLU3~SANOFI PASTEUR~U2438AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296358	11/09/2007	MN	52.0	52		M	11/09/2007	Extremely swollen, painful arm in which received both pneumonia and Flu vaccine right vaccine. Arm red, tender to touch, unable to move. Resolving by 11/5/07 Unable to determine which site as entire affected.									Y	11/01/2007	11/01/2007	0		PUB	PVT	Numerous	None	degenerative joint disease; Diabetes type 2			1						1	Erythema; Injected limb mobility decreased; Oedema peripheral; Pain in extremity; Tenderness	FLU3~SANOFI PASTEUR~U2489AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0038U~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296360	11/09/2007	CO				M	10/31/2007	Pre-existing complex regional pain syndrome in left lower extremity. Three days following flu shot he presented with pain, swelling, mottling, decreased temp., of his right upper extremity from mid forearm distal to entire hand. Vaccine was given in left deltoid.				Y					U	10/17/2007	10/19/2007	2		PVT	PVT	Lyrica; Zoloft; Nifedipine; Alavert; Magnesium; B-12	Runny nose, cough, bloody nose	Complex regional pain syndrome; Left lower extremity	pain syndrome~Vaccine not specified (no brand name)~UN~0.00~In Patient		1						1	Body temperature decreased; Feeling cold; Livedo reticularis; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2451AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296361	11/09/2007	ME	5.0	5		M	11/06/2007	Within minutes after administration Varicella and Fluzone - patient was SOB, coughing, hives began on both thigh area and then redness over entire body chills, Benadryl 25 PO, Benadryl 25 IM and Dexamethasone 4mg IM, nebulizer with Albuterol and Pulmicort				Y					Y	11/06/2007	11/06/2007	0		OTH	PUB		None	Asthma	~DTaP (no brand name)~5~4.00~In Patient	ME01407	1						1	Chills; Cough; Dyspnoea; Generalised erythema; Urticaria	FLU3~SANOFI PASTEUR~U2508AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~147U~3~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0296362	11/09/2007	NY	4.0	4		F	11/07/2007	Indurated, erythema, warmth over entire arm from deltoid muscle down to elbow.  Circumferential									Y	11/05/2007	11/05/2007	0	None	UNK	UNK						1						1	Erythema; Induration; Skin warm	FLU3~SANOFI PASTEUR~U2461DA~5~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296363	11/09/2007	MN	4.0	4		F	11/09/2007	Patient received redness on both legs and turned into a rash/ hives and also spread to her back. Patient was given 1/2 tsp. Benadryl and that helped.									Y	11/08/2007	11/08/2007	0		PVT	PVT	None	Rash/ hives increase itching	None			1						1	Erythema; Rash; Urticaria	FLU3~SANOFI PASTEUR~U2466AA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296364	11/09/2007	PA	4.0	4		F	11/09/2007	2cm erythema and induration at DTaP site.				Y					Y	11/01/2007	11/05/2007	4	None	PVT	PVT	Pulmicort; Zyrtec; Singular	None	Asthma; allergies			1						1	Injection site erythema; Injection site induration	DTAP~SANOFI PASTEUR~U1813BA~5~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2529AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296366	11/09/2007	NH	12.0	12		M	11/07/2007	Immunizations received 9:30 AM on 11/5/07. Patient developed headache, then fever and arm pain and swelling ~ 12 hours later-  Temp 103.1 degrees. Improved somewhat during day on 11/6/07, then more redness, swelling and tenderness at site (R deltoid) in AM on 11/7/07.				Y					U	11/05/2007	11/06/2007	1	U/S right arm (deltoid)	PVT	PUB	ZYRTEC 5mg PO Daily Multivitamin	None				1						1	Headache; Injection site erythema; Injection site pain; Injection site swelling; Oedema peripheral; Pain in extremity; Pyrexia; Ultrasound scan	FLU3~SANOFI PASTEUR~42524AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2423AA~1~UN~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2863AA~1~UN~RA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1073U~2~UN~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0296367	11/09/2007	NY	6.0	6		F	11/09/2007	Localized swelling and redness									Y	11/06/2007	11/07/2007	1		PVT	PVT			ALLERGY TO EGGS			1						1	Erythema; Local swelling	FLU3~SANOFI PASTEUR~U2526AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296368	11/09/2007	CA	5.0	5		F	11/08/2007	Left upper arm with moderate swelling and warmth swelling extends to 3rd of forearm. Temp to 101.5 F.									N	11/06/2007	11/06/2007	0	Going to allergist for allergy testing of vaccine	PUB	PUB	PCN - 125mg BID; Folic acid	sickle - cell anemia	sickle - cell anemia			1						1	Oedema peripheral; Pyrexia; Skin warm	DTAP~SANOFI PASTEUR~C2570AA~5~UN~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2490AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z1669~5~UN~RA~POLIO VIRUS, INACT. (IPOL)~1|PPV~MERCK & CO. INC.~0889F~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296369	11/09/2007	IN	3.0	3		M	11/08/2007	fever, seizure				Y					Y	11/05/2007	11/06/2007	1	CBC, Chem 14, Blood culture, and Urine normal	PVT	PVT		None	Hypothyroidism and Diabetes Inspidus			1						1	Blood culture negative; Convulsion; Full blood count normal; Laboratory test normal; Pyrexia; Urine analysis normal	FLU3~SANOFI PASTEUR~U2486AA~3~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296370	11/09/2007	NJ	6.0	6		M	11/09/2007	Localized reaction 6 x 8 cm erythematous left deltoid region -									U	11/08/2007	11/08/2007	0	prescribed. Atarax and Westcort cream	PVT	PVT	Amoxicillin finish 11/3/07.	None	10/24/07 - LOM -			1						1	Erythema; Local reaction	FLU3~SANOFI PASTEUR~62506aa~6~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296372	11/09/2007	WI	38.0	38		F	11/09/2007	Within 30 minutes after Influenza vaccine given client complained of tachycardia, tongue and throat feeling picky. Then throat felt thick and swollen.									Y	11/06/2007	11/06/2007	0	None	PVT	PVT		None	Hayfever - environmental	~Td Adsorbed (no brand name)~UN~6.00~In Patient		1						1	Paraesthesia oral; Pharyngeal oedema; Tachycardia; Throat irritation	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA300CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296291	11/10/2007	WA	49.0	49		M	11/10/2007	fever,chills, night sweats(lots of it),vomiting,lack of appetite,coughing, severe general weakness, unable to work for almost a week hospital makes all its employees to take this flu shot)and I am still not well! 11/27/07 Reviewed medical records from outpatient clinic of 11/1/07 which reveals patient experienced upper respiratory symptoms, enlarged llefttemporal artery & viral syndrome x 3-4 days.  Achy all over, fever, sore throat, sinus congestion, runny nose, tired, decreased appetite.  Wife & children also sick.  Consult of 11/5/07 reveals dx of elevated acute phase reactants attributed to recent viral syndrome; palpable temporal artery w/no evidence of temporal arteritis or polymyalgia rheumatica. FINAL DX: viral syndrome.			Y						N	10/25/2007	10/30/2007	5	LABS: CRP 57 (H).  ESR 17 (H).	UNK	UNK		NONE	NONE PMH: recent acute viral syndrome; remote history of anxiety/depression.			1						1	Anorexia; Asthenia; Chills; Cough; Malaise; Night sweats; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~42475GA~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0296315	11/10/2007	KY	39.0	39		F	11/10/2007	Pt stated that had an event with flu vaccination 17 years ago, but has had several flu shots without incident since then.  I verified 2 shots in the system.  On 11/9/2006, at approximately 0900, after consulting me, I advised to give it. She received it, but within several minutes had a local reaction, with a 1 cm wheal (dark complexion makes for more difficult assessment). Noted swelling, redness, warm to touch, and blister at site of injection. Requested that the patient wait. I arrived approximately 0930 am with a frozen cold pack wrapped in a blue chucks. She applied this to the site.  I advised that normal protocol would be to be monitor for 4 hours following the injection. Pt states that she felt better and that she was remaining on post.  I instructed her to seek immediate care should she note symptome worsening or respiratory involvement. She called me at approximately 1700 to confirm that she is feeling fine.									Y	11/09/2007	11/09/2007	0		MIL	MIL		none	n/a			1						1	Injection site erythema; Injection site swelling; Injection site vesicles; Injection site warmth; Local reaction; Similar reaction on previous exposure to drug; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA049AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0296316	11/10/2007	MN	0.75	0	.8	M	11/10/2007	Fussy, irritable, red rash (not bumpy) all over body, restless, fever of 101 degrees, vomiting. Rash started 1 hour after injection. Fever started 4 hours after injection, lasted 12 hours (administered Tylenol).									U	11/09/2007	11/09/2007	0		PVT	PVT	Ranitidine	none	reflux			1						1	Irritability; Pyrexia; Rash erythematous; Restlessness; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296318	11/10/2007	IA	67.0	67		F	11/10/2007	Patient developed pain with in the left arm a hour or two after receiving her immunizations. The sever pain is limiting mobility in that arm. She has taken Ibuprofen periodically over the last 18 hours without relief. She has been advised to use warm compresses and to see a doctor at one of the urgent care facilities in town.				Y					U	11/09/2007	11/09/2007	0	n/a	UNK	UNK	Fosinopril	No	High Blood pressure			1						1	Heat therapy; Mobility decreased; Pain in extremity; Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2487aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~UNK~IM~UN~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0296320	11/10/2007	MA	68.0	68		F	11/09/2007	Red pimples. Mostly over the back and sides. Some on abdomen and upper thighs. Raised centers, which turned yellow. At home treatment with cortisone cream. Slightly itchy. Presently fading.									Y	10/29/2007	11/02/2007	4		UNK	UNK		None	None			1						1	Acne; Pruritus	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296321	11/10/2007	WA	14.0	14		F	11/10/2007	Patient experienced pain on injection site immediately after injection.  An ice pack was given to the patient.  Minor erythema developed at injection site.  Difficult to differentiate whether or not it was from the ice pack.  Shortly thereafter the patient developed breathing problems that became increasingly worse.				Y					Y	10/26/2007	10/26/2007	0	Paramedics evaluated patient at decided not to take her to the hospital.	UNK	UNK	None	None	None			1						1	Dyspnoea; Immediate post-injection reaction; Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U2453AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296322	11/10/2007	CA	48.0	48		F	11/10/2007	Pain in left deltoid where shot was administered has not subsided, it's been 4 days now and I'm still having pain as thought I've been punched in the arm (really hard). I do not have full use of my arm nor full range of motion. The pain is only where the shot was administered not my entire arm, due to the pain my arm is weakened.									N	11/06/2007	11/07/2007	1		UNK	PVT	Combi-Patch (HRT); Lexapro 10 mg; Paxil and Simvastatin	none.	Peri-menopause and Heart Disease (CAD)	none~ ()~NULL~~In Patient		1						1	Injected limb mobility decreased; Injection site pain; Joint range of motion decreased; Muscular weakness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80824~4~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0296323	11/10/2007	GA	17.0	17		F	11/10/2007	Patient received 3rd HPV vaccine and flu shot in right upper arm on 10/19/07. At time vaccine (HPV first) was given she experienced extreme pain described as a line down her arm into her thumb.   Patient asked employee to wait until the pain subsided some before giving the flu shot.  Flu shot was then given in same arm a couple of minutes later.  Over the course of the next few weeks, the pain somewhat subsided in the whole arm and was more above the elbow to the injection site.  The pain has been so extreme that it has woken the patient from sleep on 3 occasions. Returned to Dr on November 7, 2007 for an evaluation.  Dr. ordered shoulder xrays, physical therepy, 600 MG ibuprofin 3X a day until further notice and would consult with another doctor and be in touch about recommendations for further assessment. NOTE:parent observation of injection was that the  injection was given in a manner of puncture/poke like compared to more of a pushing the injection into the arm.  There was no 'squeezing' of the muscle/arm prior to injection. This is in follow-up to report(s) previously submitted on 2/14/2008. Information has been received from a physician concerning a 17 year old female who on 20-NOV-2007 was vaccinated IM into his left deltoid with a first dose of GARDASIL (lot#655327/1287U). Within 15 minutes, the patient fainted and stopped breathing for a moment. It was reported that the patient sat for 15 minutes and when she walked into the waiting room she passed out for about a minute. The patient was conscious but not talking and clammy. After 10 minutes (approximately) of being monitored the patient became talkative and laughd about what happened with her mother. An ambulance was called but the patient was not admitted to the hospital. Unspecified medical attention was sought. On 20-NOV-2007, the patient recovered. No product quality complaint was involved. Additional information is not expected.				Y					Y	10/19/2007	10/19/2007	0	xrays, haven't received results yet (11/10/07);	PVT	PVT	Unknown	ongoing sinus infection - no fever	none		WAES0801USA01707	1						1	Pain in extremity; X-ray	FLUX~UNKNOWN MANUFACTURER~~6~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPVX~UNKNOWN MANUFACTURER~1287U~3~IM~RA~HPV (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0296324	11/10/2007	CA	62.0	62		F	11/10/2007	I received the shot at 1:00 p.m.  At 7:30 I started feeling chilled and kind of dizzy, and couldn't see real clearly.  I took 600mg. motrin, a warm bath because of the chills and went to bed.  I woke up about every half hour because of a severe headache, very bad body aches, and a fever of 103.8.  I had this until 11:00 A.M.  I took 800mg. motrin and went back to bed, and slept for about an hour.  When I woke up I felt alot better.  The temp. went down as the day went on and by around 4:00 had a minor headache and lower fever.									Y	11/09/2007	11/09/2007	0		UNK	UNK	0.3/1.5 Prempro, 20 mg.Lipitor, 25 mg.Toprol xl, 50mg.Elavil, 30mg Prevacid, .0/1 Synthroid	none	fibromyalsia	none, my son and daughter both had adverse reactions to the flu vaccine one time each.  My son had to go to the hospital.  This 		1						1	Chills; Dizziness; Headache; Pain; Pyrexia; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296325	11/10/2007	MO	57.0	57		M	11/10/2007	Chills and fever, 48 hours									Y	11/05/2007	11/05/2007	0		UNK	PVT						1						1	Chills; Pyrexia	FLU3~SANOFI PASTEUR~02488AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0963U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296326	11/11/2007	TX	3.0	3		M	11/11/2007	Flu shot was received on monday nov.5th, on tues evening tristan was feeling very tired. On wed. he complained of being very tired and late evening began to vomit.  Thurs, he slept all day not eating anything and had not had an appetite up to this day.  Fri, he woke up vomitting, and continued throughout the day. He had finally eaten 1/2 a sandwhich on fri. afternoon.  He woke up vomitting early sat. morning and I took him to the er to make sure that he was okay.  They took chest xrays because as of Wed. he had developed a cough.  Chest xrays were clear and we were released.  Sat. afternoon and evening he continued to vomit and at this time has now developed diarrehea				Y					U	11/05/2007	11/06/2007	1	Chest xrays	PVT	PVT	n/a	none	acid reflux as an infant			1						1	Chest X-ray; Cough; Decreased appetite; Diarrhoea; Fatigue; Vomiting	FLUX~UNKNOWN MANUFACTURER~000000000000000~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0296327	11/11/2007	MA		56		F	11/11/2007	Patient with outbreak of Shingles 24 hrs after receiving influenza vaccination per report.										10/24/2007	10/25/2007	1		UNK	UNK						1						1	Herpes zoster	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296328	11/11/2007	CO	57.0	57		F	11/11/2007	Severe pain right shoulder and right scapula; beginning to show signs of winged scapula.									Y	11/01/2007	11/02/2007	1	None	UNK	UNK		None	In Sept. 2003 I had West Nile Virus and was hospitalized for about one month with menengitis, encephalitis and right side partial paralysis.  After being released from the hospital I was diagnosed with a right winged scapula.  I also have systemic lupus since age 25.			1						1	Musculoskeletal pain; Winged scapula	FLUX~UNKNOWN MANUFACTURER~unknown~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296329	11/11/2007	MO	23.0	23		F	11/11/2007	I am going on day 7 of random and inconsistent: Dizziness Body aches Chills Fever Sweats Blurred Vision Nausea Extreme Arm Pain (In the injected arm)  Head Ache I went to my Dr. on 11-07-07. My Dr. gave me Tamadol for the pain and MethylPREDSNISolone for the infection.   I have also been treating with IBProfen, heat, and cold packs.				Y					N	11/05/2007	11/05/2007	0		UNK	PVT		none	none			1						1	Chills; Dizziness; Headache; Hyperhidrosis; Nausea; Pain; Pain in extremity; Pyrexia; Vision blurred	FLU3~SANOFI PASTEUR~02488AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0963U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0296330	11/11/2007	MO	40.0	40		F	11/05/2007	I received both the flu shot and the pneumonia shot around 9:00am.  Around 4:00pm I started running a temperature of 100.6 degrees.  I took some ibuprofen and laid down.  Both shots were given in my left arm.  My arm was so sore that I could not touch it.  All through the night I continued to run a fever between 100 degrees to 102 degrees.  On 11-06-07 I woke up with a knot on my neck.  The knot was about the size of half of a baseball and located on my collar bone.  I continued to have a fever throughout the day.  My arm and the knot on my neck stayed very sore for two more days.  It is now 11-11-07 and the knot on my neck has gone down quit a bit but it is still visible.  I went to see my doctor on Thursday, 11-08-07.  He stated that I was having a reaction to the vaccinations but could not tell which one since they were both given in the same arm.  I was told to let him know if the knot did not go down and some tests would have to be run.				Y					U	11/05/2007	11/05/2007	0		UNK	UNK	none	no	no	no~ ()~NULL~~In Patient		1						1	Immunisation reaction; Local swelling; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~02488AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0963U~3~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0296331	11/11/2007	CA	64.0	64		M	11/11/2007	Fever, malaise, nasal congestion since several hours after influenza vaccine. Still on-going four days later.									N	11/07/2007	11/07/2007	0	none	PVT	UNK	none	none	none	none~ ()~NULL~~In Patient		1						1	Malaise; Nasal congestion; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296333	11/11/2007	MN	54.0	54		M	11/11/2007	Start: 6-12 hours after injection: Fever 102 degrees, dropped to 100 or less in 24 hours. Muscle aches, painful skin, headache.									Y	11/09/2007	11/10/2007	1		PUB	PVT		none				1						1	Headache; Myalgia; Pain of skin; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296335	11/11/2007	AL	47.0	47		F	11/11/2007	localized rash on trunk-- had physician care- called in to report a week later									Y	10/22/2007	10/23/2007	1	none	PUB	PVT		none known				1						1	Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79718~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0294648	11/12/2007	TX	59.0	59		F	11/12/2007	Left upper arm where the vaccination was injected became red, hot to touch, sore even to touch and my mother could not lift her arm to her waist.  She then became ill with flu lie symptoms.  She went to her primary physician on 10/19/07 but he dismissed her symptoms as a virus and sent her home with pain pills and antibiotics.  By Sunday, 10/21/07, cellulitis had set in, spread, and she was admitted to the medical center.  She suffered multi vital organ failure and many surgeries to cut out the fleah eating bacteria she contracted.			Y	Y	Y	45	Y		U	10/16/2007	10/16/2007	0		UNK	UNK						1						2	Asthenia; Cellulitis; Intensive care; Mechanical ventilation; Cellulitis; Influenza like illness; Injected limb mobility decreased; Injection site erythema; Injection site pain; Injection site warmth; Multi-organ failure; Surgery; Cellulitis; Intensive care; Mechanical ventilation; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78994~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78994~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~3	USA	Life Threatening,Hospitalisation	Influenza
0296373	11/12/2007	CA	81.0	81		F	11/12/2007	my grandmother drove herself to get her flu shot on Tuesday, October 16th. On Wednesday, she felt very achy and nauseous, although she was tolerating liquids. No vomiting. Then on Thursday, the 18th, she couldn't walk. It took her an hour and a half to get out of bed. 911 was called and she was taken to the local er.  1/18/08 Reviewed hospital medical records which reveal patient experienced generalized weakness, left hip pain & severe back pain.  In ER, had leukocytosis & presumed sepsis.  Admitted 10/18-11/3/2007.  Tx w/IV antibiotics.  ID, Ortho, Urology consults done.  Transferred to SNF for rehab & to decide re nephrectomy or hospice FINAL DX: Renal cell carcinoma; severe DDD of spine; pneumococcal bacteremia; pneumococcal pneumonia.			Y	Y	Y	16	Y		U	10/16/2007	10/17/2007	1	she developed a strep pneumonia blood infection, blood cultures were drawn on October 18th in the er. i was told yes she had pneumonia and no she didn't by 2 different doctors. LABS: WBC 19.7K  Electrolyte imbalance.  Blood c/s (+) for strep. pneumoniae.  CXR (+) LLL pneumonia.  X-rays of back showed extensive DDD.  Left hip x-ray revealed s/p THR.  CT & MRI of spine revealed severe DDD but no definitive mets.  CT biopsy of left renal mass (+) for renal cell carcinoma.	UNK	UNK	synthroid, premarin,mvi, glucosamine.	copd.	allergic to sulfa. hx hypothyroidism,hysterectomy,smoker,copd,(no home oxygen), left hip replacement,arthritis. PMH: degenerative arthritis, COPD, hypothyroidism.  Allergic: sulfa.  Smoker & uses ETOH			1						1	Abasia; Nausea; Pain; Pneumonia pneumococcal; Streptococcal bacteraemia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA066AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Life Threatening,Hospitalisation	Influenza
0296374	11/12/2007	MO	60.0	60		F	11/12/2007	Received on Monday--fine that day.  Arm got reallty sore on Tuesday-Wednesday & Thursday.  On Thursday I had the chills in the afternnon and that evening.  It is 1 week later to the day and I still have a knot in my arm that is a bit tender									U	11/05/2007	11/06/2007	1		UNK	UNK						1						1	Chills; Pain in extremity; Skin nodule; Tenderness	FLU3~SANOFI PASTEUR~02488AA    IM~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0963U        IM~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296375	11/12/2007	MO	45.0	45		F	11/12/2007	Shots were given in left arm. Arm became swollen and red with a streak of red radiating to the arm pit. Arm was very soar to the touch and hurt when moved.									Y	11/05/2007	11/05/2007	0		UNK	PVT		none				1						1	Erythema; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~02488AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0963U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296376	11/12/2007	OH	52.0	51		F	11/12/2007	Received Influenza vaccination on 10/26/07.  Describes a 3-day delay, then increased pain, localized swelling, non-erythematous.									N	10/26/2007	10/29/2007	3	none	PUB	PVT						1						1	Pain; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA294ba~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296377	11/12/2007	MO	49.0	49		F	11/12/2007	Chills - High Fever - Aches (my whole body hurt) - Lethargic - Headache - swelling, redness, and pain at the injection site									Y	11/05/2007	11/05/2007	0		UNK	PVT	Tylenol, Allegra, Multi-Vit, Diuretic, Garlic, Fiber	None	None			1						1	Chills; Headache; Injection site erythema; Injection site pain; Injection site swelling; Lethargy; Pain; Pyrexia	FLU3~SANOFI PASTEUR~02488AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0963U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296378	11/12/2007	TN	7.0	7		M	11/12/2007	Patient received influenza vaccination and while walking to waiting room patient passed out.  Patient turned pale and mother carried him back to a room.  Vitals were monitored and legs elevated.									Y	11/12/2007	11/12/2007	0	none	PVT	PVT	Nasonex and Zyrtec	viral infection	migranes			1						1	Loss of consciousness; Pallor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80074~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0296379	11/12/2007	MI	47.0	47		F	11/12/2007	Approximately 30 min after receiving flu shot pt c/o chest pain, severe headache and chills. Stated she felt like her asthma was acting up. BP slightly elevated at 184/88. She wanted to go home and lay down. Recommended she go to ER. Went to ER w/ employee. During a 4 day stay she failed a stress test, had 2 CAT scans and a heart cath that was neg. Hospital stated she had a systemic rxn to flu shot.   11/30/07 Reviewed hospital medical records which reveal patient experienced substernal chest pain, sweating, SOB & HA approx 30 min s/p flu vax.  Admitted 11/5-11/8/2007. FINAL DX: atypical chest pain w/possible drug reaction vs musculoskeletal pain; bronchial asthma; uncontrolled DM.				Y	Y	4			Y	11/05/2007	11/05/2007	0	Stress test, 2-CAT scans, negative heart cath. LABS: stress test (+) for large anterior wall defect & hypokinesia.  Cardiac cath WNL, EF 60%.  CT of chest WNL.  Blood glucose (H) throughout hospitalization. HgbA1C 9.9 (H).  cholesterol 248 (H), LDL 183 (H).  Troponin neg.  CBC WNL.	UNK	UNK			Diabetes, CKD PMH: Type 2 DM uncontrolled, HTN, hyperlipidemia, morbid obesity, bronchial asthma untreated.			1						1	Asthma; Blood pressure increased; Catheterisation cardiac normal; Chest pain; Chills; Computerised tomogram; Condition aggravated; Headache; Vaccination complication	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81113~1~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0296380	11/12/2007	MO	41.0	41		F	11/12/2007	began low feaver by noon on day of vaccine.  by 10pm high feaver 102 + the high fever lasted until thrusday afternoon.  arm pain increasing daily.  on friday at noon, visited local doctor to discover an infection at the injecetion site.  currently taking antibiotics, however pain is still present and persistent.  a hard knot can be felt under the skin at injection site as of 11/12/07									N	11/05/2007	11/05/2007	0		UNK	UNK		none	none			1						1	Injection site infection; Injection site nodule; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~02488aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0963u~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296382	11/12/2007	MO	25.0	0	.8	F	11/12/2007	Sore arm day of and up to three days after.  No flu symptoms.									Y	11/05/2007				UNK	UNK	none	none	none			1						1	Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0296383	11/12/2007	IL	52.0	52		M	11/12/2007	At 10:15 am on Nov. 7, 2007 I received the PPV immunization.  Through the day my arm got more and more sore.  By 6 pm I could not lift my arm more than a foot above my body.  I also started feeling generally sick, with a fever and chills and feeling pretty bad all around.  I went to bed about 11 pm, my usual time, having stayed on the couch the better part of the afternoon and all evening.  At 1:30 am the next day I woke with a pulsing, throbbing pain in my arm where I had received the PPV shot.  I went downstairs to take two aspirin to relieve the pain.  In the bathroom I blacked out twice but remained standing.  I went to the kitchen to get milk to take the aspirin with.  I blacked out and fell at least once, perhaps twice, in the kitchen while getting the milk.  Each time I woke up on the floor with no recollection as to how I got there.  Luckily I did not hit my head or any other parts of my body when I fell.  I was clearly not thinking rationally, and I was not thinking clearly.  I was driven to take the aspirin and get back to bed, but my brain was not functioning well.  Each time I awoke on the floor I remember thinking, I have to get up, but I had no feeling that things were not right.  I climbed upstairs toward our bedroom (although I have no recollection of walking or climbing the stairs), and I blacked out and fell again in the upstairs hallway.  Again, luckily, I did not hit my head on anything severely when I fell.  I awoke and found myself on the floor, but I did not know how I had gotten there.  Again my driving thought was to get back to bed.  My wife kept asking me if I was okay and I guess I said I was, but my mind was not functioning much at that time.  I was just driving myself to get back into bed.  I got into bed, where I broke out in a complete, drenching sweat over all of my body.  My fever also increased dramatically, but after the sweat came out completely I started to cool off somewhat.  I kept telling my wife I did not want to go to the hospital (although this was not a rational person speaking, especially when I was downstairs and just after I got back into bed).  I fell asleep fairly soon (~15 minutes or so) and slept fairly well that night.  My arm was very sore for the next 24 hours, and I could not lift it more than a foot or two all day.  I took four aspirins during the day to help relieve the arm ache.  I rested that entire day and did not work that day.  Toward that evening the pain where the shot was given started to decline, and I started to feel somewhat normal.  The next day I could lift my arm higher and the pain continued to subside.  By day three I was back to almost normal.  I had had no alcohol to drink on the day of my PPV shot and only the .5 milligram Ativan at night as per my usual routine, so I am sure it was the PPV shot that had caused my severe reaction.  My left arm, where I got my flu shot at the same time as the PPV shot, felt fine from the time of the shot.									Y	11/07/2007	11/07/2007	0	None	UNK	PVT	.5 mg Ativan daily	None	None	None~ ()~NULL~~In Patient		1						1	Chills; Fall; Hyperhidrosis; Injected limb mobility decreased; Injection site pain; Loss of consciousness; Malaise; Pain; Pain in extremity; Pyrexia	FLUX~UNKNOWN MANUFACTURER~Unknown~2~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~Unknown~1~UN~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0296384	11/12/2007	TN	46.0	46		F	11/12/2007	profusley sweating,blood presure dropped,faint-dizzy,nausea,diarrhea,weakness.				Y					Y	10/08/2007	10/09/2007	1		PVT	PVT	clarinex	laryngitist/larynx problems and loss of large toe nails. *** no fever,soreness in throat,or drainage.	allergic to penicillin,many substitutions to penicillin's erithomyns,sulhur med's,neosporin oinments,some latex products.			1						1	Asthenia; Blood pressure decreased; Diarrhoea; Dizziness; Hyperhidrosis; Nausea; Syncope	FLUX~UNKNOWN MANUFACTURER~af11a042aa~1~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0296385	11/12/2007	MN	50.0	50		F	11/12/2007	Local reaction. Raised wheal 2.25 in (5.5 cm) in diameter, painful and reddened, appeared within 5 hours. Remains raised/painful >48 hours after injection. Ice applied periodically.									Y	11/09/2007	11/09/2007	0		PVT	PVT	Enalapril 5 mg, Aspirin 81 mg, Centrum Silver multivitamin, Claritin 12 hr	None	Sulfa drugs (hives), penicillin (hives).  Pre-existing hypertension			1						1	Erythema; Local reaction; Pain; Urticaria	FLU3~SANOFI PASTEUR~U2528AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296386	11/12/2007	GA	56.0	56		U	11/12/2007	aBOUT 5 HOURS AFTER RECIEVING SHOT I BEGAN TO ACHE ALL OVER APPROX8 HRS AFTER SHOT i BEGAN WHEEZING BADLY LIKE I WAS DROWNING IN FLUIDS AND I GOT CHILLS AND FEVER I WAS SHAKING SO BAD i COULD NOT EVEN TALK  I GOT UNDER ELECTRIC BLANKET ON HIGH AND COVERED UP, EVEN MY HEAD UNDER 4 MORE QUILTS.2 DAYS LATER I GOT A COLD THAT I STILL HAVE AND MY BODY IS STILL ACHING ALL OVER.WILL PROB SEE DR TOMMORROW  tHIS IS THE 2ND TIME TO TAKE THE FLU SHOTAND THE SAME REACTION BOTH TIMES COLD LAST ABOUT 6 WEEKS									N	10/25/2007	10/25/2007	0		UNK	UNK	LISINOPRIL, LIBRAX, OSCAL D BONIVA PREMRIN	DRY COUGH	DIVERTICULA ,HORMONES , HIGH BLOOD PRESSURE, OSTEOPOROSIS	2002~Influenza (Seasonal) (no brand name)~1~51.30~In Patient		1						1	Chills; Nasopharyngitis; Pain; Pyrexia; Similar reaction on previous exposure to drug; Tremor; Wheezing	FLUX~UNKNOWN MANUFACTURER~00000~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296388	11/12/2007	MI	64.0	64		F	11/11/2007	Received pneumonia vaccine on Friday 11/9/07, on Saturday night I was up during the night and could not sleep, left arm was sore but not red. Sunday I had muscle aches and fever up to 100.8,I took Tylenol extra strength for pain and fever around the clock. Last night 11/10/07 fever broke and muscle weakness stopped. Today 11/11 I put ice on the site, area is red about two inches around the sight. Left message on my Doctor's answering service Monday 11/11/07 regarding these symptoms.									U	11/09/2007	11/10/2007	1		PUB	PUB	Avalide 125/12.5, Singular 10mg, Hydroclorizide 25, Armour Thryroid 60mg, Loratine 10 mg, Xalatan eye drops, Qvar inhaler two puffs each day.  Veramyst, two inhal each nostril, daily, Estrace,Estridol,DHEA & Progesterone cream q12hr., Priso	Osteo and  Rheumotoid arthritis, Asthma,  Glaucome. Duodenal Ulcer, gastritis,	Allergice to molds, dust mites,Percodan,Timoptic/xe eye drops, shrimp	~ ()~0~~In Patient		1						1	Injection site erythema; Muscular weakness; Myalgia; Pain in extremity; Pyrexia; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~2478BA~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~0038U~2~IM~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0296389	11/12/2007	NJ	50.0	50		F	11/12/2007	I felt totally fine prior to vaccination. 3 hours after receiving the vaccine, cough and some wheezing developed.  It was uncomfortable to swallow, like a big lump was in my throat.  I developed shaking chills, purulent drainage from my eyes.  I also became nauseous and vomited.  I used Maxair inhaler and Benadryl for the tight cough and wheeze.  Fortunately, symptoms were relieved after several hours and I opted not to be seen for treatment.									Y	10/20/2007	10/20/2007	0		UNK	UNK	Synthroid, Zegerid, Glucosamine	None	Hypothyroid, Mitral regurgitation			1						1	Chills; Cough; Dysphagia; Eye discharge; Nausea; Purulent discharge; Sensation of foreign body; Tremor; Vomiting; Wheezing	FLU3~SANOFI PASTEUR~U2527AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296391	11/12/2007	PA	52.0	52		F	11/12/2007	localized swelling in Left neck and  clavical area. Vaccine given in left arm.  Ibuprofin 800 mg q 8 hours for two days									Y	10/17/2007	10/17/2007	0	none	MIL	UNK	Toporol XL 25mg hs   15mg am daily,MVI 1 daily, asa 81 mg daily,Fish Oil 1200 mg 2 am 2 pm daily, Niacin 250 mg hs	none		none~ ()~NULL~~In Patient		1						1	Local swelling	FLU3~SANOFI PASTEUR~SP log U2493aa~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296392	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequently adverse events. On an unspecified date on or after 21 October 2001 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	UNK	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see cases A0693686 and A0693696A through A0693718A.		A0693695A	1						1	Injected limb mobility decreased; Injection site irritation; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296393	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	UNK	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see cases A0693686 and A0693695A through A0693718A.		A0693696A	1						1	Injected limb mobility decreased; Injection site irritation; Injection site pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALFUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296394	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	UNK	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see cases A0693686 and A0693695a through A0693718A.		A0693697A	1						1	Injected limb mobility decreased; Injection site irritation; Injection site pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALFUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296395	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	UNK	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see cases A0693686 and A0693695A through A0693718A.		A0693698A	1						1	Injected limb mobility decreased; Injection site irritation; Injection site pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALFUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296396	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	UNK	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see cases A0693686 and A0693695a through A0693718a.		A0693699A	1						1	Injected limb mobility decreased; Injection site irritation; Injection site pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALFUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296397	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	UNK	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see cases A0693686 and A0693695a through a0693718A.		A0693700A	1						1	Injection site irritation; Injection site pain; Joint range of motion decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALFUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296398	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	UNK	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see cases A0693686 and A0693695A through A0693718A.		A0693701A	1						1	Injection site irritation; Injection site pain; Joint range of motion decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALFUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296399	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	UNK	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see cases A0693686 and A0693695A through A0693718A.		A0693702A	1						1	Injection site irritation; Injection site pain; Joint range of motion decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALFUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296400	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	UNK	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see cases A0693686 and A0693695A through A0693718A.		a0693703a	1						1	Injection site irritation; Injection site pain; Joint range of motion decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALFUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296401	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	UNK	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see cases A0693686 and A0693695A through A0693718A.		A0693704A	1						1	Injection site irritation; Injection site pain; Joint range of motion decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALFUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296402	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	UNK	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see cases A0693686 and A0693695A through A0693718A.		A0693705A	1						1	Injection site irritation; Injection site pain; Joint range of motion decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALFUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296403	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	UNK	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see cases A0693686 and A0693695A through A0693718A.		A0693706A	1						1	Injection site irritation; Injection site pain; Joint range of motion decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALFUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296404	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	UNK	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see cases A0693686 and A0693695A through A0693718A.		A0693707A	1						1	Injection site irritation; Injection site pain; Joint range of motion decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALFUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296405	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	UNK	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see cases A0693686 and A0693695A through A0693718A.		A0693708A	1						1	Injection site irritation; Injection site pain; Joint range of motion decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALFUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296406	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	UNK	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see cases A0693686 and A0693695A through A0693718A.		a0693709a	1						1	Injection site irritation; Injection site pain; Joint range of motion decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALFUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296407	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	UNK	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see cases A0693686 and A0693695A through A0693718A.		a0693710A	1						1	Injection site irritation; Injection site pain; Joint range of motion decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALFUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296408	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	UNK	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see cases A0693686 and A0693695A through A0693718A.		A0693711A	1						1	Injection site irritation; Injection site pain; Joint range of motion decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALFUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296409	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with (Fluarix, GlaxoSmithKline) for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	Unknown	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see cases A0693686 and A0693695A through A0693718A.		A0693712A	1						1	Injection site irritation; Injection site pain; Joint range of motion decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296410	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with (Fluarix, GlaxoSmithKline) for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	UNK	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see cases A0693686 and A0693695A through A0693718A.		A0693713A	1						1	Injection site irritation; Injection site pain; Joint range of motion decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296411	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	UNK	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see cases A0693686 and A0693695A through A0693718A.		A0693714A	1						1	Injection site irritation; Injection site pain; Joint range of motion decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALFUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296412	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	UNK	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see cases A0693686 and A0693695A through A0693718A.		A0693715A	1						1	Injection site irritation; Injection site pain; Joint range of motion decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALFUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296413	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	UNK	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see cases A0693686 and A0693695A through A0693718A.		A0693716A	1						1	Injection site irritation; Injection site pain; Joint range of motion decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALFUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296414	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	UNK	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see cases A0693686 and A0693695A through A0693718A		A0693717A	1						1	Injection site irritation; Injection site pain; Joint range of motion decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALFUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296415	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with (Fluarix, GlaxoSmithKline) for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subject adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth of redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	Unknown	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see cases A0693686 and A0693695A through A0693718A.		A0693718A	1						1	Injection site irritation; Injection site pain; Joint range of motion decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALFUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296429	11/12/2007	MI				U	11/12/2007	This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline). The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.				Y					N	10/01/2007	10/01/2007	0	UNK	PUB	PVT		Unknown	The healthcare professional reported that the clinic has administered at least 1,700 Fluarix vaccinations and out of that number 25 subjects experienced burning discomfort at the injection site (Deltoid), radiating pain, and range of motion deficit. Please see case  A0693695A through A0693718A.		A0693686A	1						1	Injection site irritation; Injection site pain; Joint range of motion decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALFUA319AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296431	11/12/2007	CA	5.0	5		M	11/09/2007	Initial report received from a health care professional on 30 October 2007. A five-year-old male with history of reactive airway disease and possible allergies to peanuts and amoxicillin had received a left deltoid intramuscular injection of Fluzone SV  2007-2008 (lot number U2530AA) on 27 October 2007 and within a few hours of the vaccination, he started developing soreness and swelling near the left deltoid injection site. The following day, the patient was taken to Ready Care, as the swelling had extended to his elbow. Treatment with Septa was initiated. The patient was seen by his pediatrician on 29 October 2007 and was dose of epinephrine and was started on Benadryl. By October 2007, the swelling had extended to the patient's wrist. At the time of this report, the patient had not recovered. No additional information was provided.				Y					N	10/27/2007	10/27/2007	0		PVT	OTH	FLOVENT, ALBUTEROL		The patient had a history of reactive airway disease and possible allergies to peanuts and amoxicillin. Concomitant medications were Flovent and albuterol, as needed. The patient had no illness at the time of vaccination. It was reported that other vaccinations received within four weeks prior to 27 October 2007 were: Varivax (manufacturer Merck, lot number 0446U, administered to right triceps); MMR (manufacturer Merck, lot number 1030F, administered to the left triceps); and Polio vaccine (manufacturer sanofi pasteur, lot number Z0326, administered to the right triceps). However, the administration date for Varivax was reported as 04 June 2007 and administration dates for the MMR and Polio vaccines were not reported.		200703690	1						1	Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2530AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296435	11/12/2007	MO	46.0	46		F	11/12/2007	Soreness and swelling at injection sight ran low grade fever and general feeling of illness									Y	11/05/2007	11/05/2007	0		UNK	PVT						1						1	Injection site pain; Injection site swelling; Malaise; Pyrexia	FLU3~SANOFI PASTEUR~02488AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0963U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296436	11/12/2007	MA	63.0	63		F	11/12/2007	I had a flu shot at 6 o'clock in the evening last Wednesday. At 9, I was really cold so figured I was tired. Well, I had a fleece jacket on, which I left on when I went to bed b/c I was so cold. At 11:30, I woke up shivering. Obviously, I had a high fever but didn't know if I should take anything for it because of the flu shot. So, I just stayed in bed and hoped it would subside and that I'd fall asleep again. I shivered for two solid hours before things settled down and I was able to fall asleep again.   Then, at 4:30 I woke up again (with a headache, aches, and a fever). This time I got up and took my temperature b/c I didn't feel quite as bad as last night: it was 101.4. I still didn't take anything b/c I wanted to speak with a medical person before doing that. At 8 am my temperature was 101.8, and I had a headache and some aches. I called the town health dept. when it opened, and they referred me. The nurse told me to take acetiminophen, not aspirin. I did that and my fever was gone within about 45 minutes. Four hours later, I took two more b/c I didn't feel well, but never got the fever back again. By the next day, Friday, I felt pretty good again.										11/07/2007	11/07/2007	0		UNK	UNK		none	none			1						1	Chills; Fatigue; Feeling cold; Headache; Malaise; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~?~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296437	11/12/2007	MO	53.0	53		F	11/12/2007	fever for five days (100.5 to 103 degrees), body achiness for 6 days, red rash and swelling on arm from shot area down to the elbow (persisted from 48 hours after the shot til present time, 8 days), extreme soreness in the upper arm, causing moaning during sleep and waking from sleep if the arm was touched.  The muscle area of the arm is still extremely sore, swollen, and red, requiring pain medication. The doctor was seen after 72 hours, treatment: moist compresses on the red swollen area and pain medication.				Y					N	11/05/2007	11/05/2007	0		UNK	PVT						1						1	Injection site swelling; Moaning; Myalgia; Oedema peripheral; Pain; Pain in extremity; Pyrexia; Rash erythematous	FLU3~SANOFI PASTEUR~02488AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0963U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0296438	11/12/2007	TX	41.0	41		F	11/12/2007	pain and numbness to left arm, with headache soon after receiving vaccine; took Ibuprofen for achy arm but symptoms lasted for about a week; within 10 days, arm pain resolved but started to feel pressure to chest and nausea with mucosy vomit and overall not feeling well; notices feeling itching to neck without rash when nauseated									Y	10/17/2007	10/27/2007	10		UNK	PVT						1						1	Chest discomfort; Headache; Hypoaesthesia; Malaise; Nausea; Pain in extremity; Pruritus; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA065AA~4~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0296439	11/12/2007	OR	58.0	58		F	11/12/2007	About 7 hours after  receiving both influenza and pneumovax 23 vaccines, bagan shivering, led to severe chills and shaking, after 3 hours it became a fever and lasted perhaps 2 hours.  The next morning there was a swollen red area, warm, firm and painful , on the shoulder about 2 inches above the injection sites.  The area is still red and slightly larger than the quarter sized area but the pain has decreased and appears to not need any further medical attention.									Y	11/09/2007	11/09/2007	0		UNK	UNK	prilosec, vitamins	none	none			1						1	Chills; Erythema; Induration; Injection site erythema; Injection site swelling; Pyrexia; Skin warm; Swelling; Tremor	FLUX~UNKNOWN MANUFACTURER~unknown~7+~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~00006-4739-00~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296440	11/12/2007	MO	23.0	23		F	11/12/2007	Received vaccination on 11/8/07 at 1:30pm and felt symptoms on 11/9/07 at 8:30pm.  Had stomach ache, which led to vomiting off and on for 6 hours.  Had diarrhea for 24 hours and a fever 2 degrees above normal.  Only lasted for 24 hours.  Drank pedialite & water, took advil, and had light foods.  Recovered quickly from most symptoms - still had slight fever second day.									Y	11/08/2007	11/09/2007	1		PUB	PUB						1						1	Abdominal pain upper; Diarrhoea; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296442	11/12/2007	VA	43.0	43		F	11/12/2007	Developed extensive swelling from site of injection up into right shoulder, right side of neck with right anterior cervical, post cervical and sight supraclavicular lymphadenopathy. Pt given DepoMedrol 160 mg IM, Prednisone 40mg taper over 4 days, and Lortabs for pain.				Y					Y	10/04/2007	10/05/2007	1	CBC	UNK	UNK	Atenolol,Zyrtec	None	ASA, Macrobid			1						1	Full blood count; Injection site swelling; Lymphadenopathy	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLA035AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0296443	11/12/2007	ID	6.0	6		F	11/12/2007	Redness,tenderness and swelling golf ball size around the site of injection				Y					Y	11/09/2007	11/10/2007	1		UNK	UNK		none	none, Adoptee			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U24414AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1013U~2~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0296446	11/12/2007	TX	59.0	59		M	11/12/2007	Received a flu vaccination on 10-29-07 and reported that the site of the injection was red, swollen and very tender for approx. 5 days.  Resolved without seeing a health care provider.									Y	10/29/2007	10/30/2007	1		PUB	PUB		None	Unknown			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2511AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296450	11/12/2007	VA	41.0	41		F	11/12/2007	I felt not well soon after the vaccine was administered (Saturdat, Nov. 3).  I was awoken with a pain in my arm at 4 am the next morning. I ran a fever of 101-102. I went to the ER and my wbc was 15,000.  I was released with levoquine.  The hot, red sore on my arm, at the injection site, was spreading and I returned to the hospital.  My white count was 18000. I was placed on vancomyacin and zosyn.  the symptoms partially remitted. I was then transferred to Zyvox (first IV and then orally) and lovoquin again and was released from the hospital on Thursday.  there was a discussion about inserting a PIC line, but I was opposed to that without a better explanation as to why one was needed. The red area appears to be resolving. I have advised Health care of this event and have urged them to report it.  11/21/2007 MR received for DOS 11/5-8/2007 with D/C DX:  Cellulitis to the LUE.  Leukocytosis with bandemia, resolved.  Diabetes mellitus Type II, HTN, Hypothyroidism, Increased LFTs. Pt noted pain and swelling to LUE and feeling feverish following Pneumovax.  Pt seen in ER and txd with abx and d/cd on po abx, but with worsening cellulits sx and elevated WBCs, she was subsequently admitted.  PE (+) for erythema, tenderness, induration and warmth at pneumovax injection site.   Pt's WBCs decreased with abx tx and pt was d/cd home.				Y	Y	4			Y	11/03/2007	11/03/2007	0	WBC was 18000 at peak.  I will release medical records if requested. The site of the infection was the pneumonia vaccine. Labs and Diagnsotics:  CBC with WBC 18.0 (up from 15.4 on 11/4/07).  CXR normal. US Abd normal.  LFTs elevated. UC no growth. Blood cultures (-). Hepatitis serologies (-).	UNK	UNK		No	sulfa eye drops; diabetes, gastroparesis. PMH:  Diabetes mellitus type II, hypothyroidism, depression, Hx of bronchitis.  Cholecystectomy.  Allergy to sulfa eye gtts.			1						1	Injection site erythema; Injection site pain; Injection site warmth; Malaise; Pain in extremity; Pyrexia; White blood cell count increased	FLU3~SANOFI PASTEUR~42492hh~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0985F~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0296452	11/12/2007	CA	41.0	41		M	11/12/2007	HE PASSED OUT, WAS NOT RESPONDING, FACE WAS PALE. HE WOKE UP ABOUT 2 MINUTES AFTER AN EPI PEN SHOT				Y					Y	11/10/2007	11/10/2007	0	DO NOT KNOW (CUSTOMER SAID THAT THE RESULTS OF HIS BLOOD TEST AND EKG DONE AT THE ER WERE NORMAL)	UNK	PVT	DO NO KNOW	DO NOT KNOW (CUSTOMER STATED THAT HE WAS NOT SICK THAT DAY)	DO NOT KNOW	DO NOT KNOW~ ()~NULL~~In Patient|DO NOT KNOW~ ()~NULL~~In Sibling1|SO NOT KNWO~ ()~NULL~~In Sibling2		1						1	Blood test normal; Electrocardiogram normal; Loss of consciousness; Pallor	FLU3~SANOFI PASTEUR~U2504AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296454	11/12/2007	MO	42.0	42		M	11/12/2007	Severe soreness in left arm (arm both injections were put in)- Tightness in chest to the point I thought I was having a heart attack - Severe pain in back -  Chills - Fever									Y	11/05/2007	11/05/2007	0		UNK	PVT						1						1	Back pain; Chest discomfort; Chills; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~02488AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0963U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296455	11/12/2007	FL		4		F	11/02/2007	Within 8 hours broke out in hives over face, neck, trunk, limbs, palms and soles. Very pruritic. No lymph nodes, no fever. Area of injection, red, swollen, warm and tender									N	10/31/2007	10/31/2007	0	None	UNK	UNK						1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2500AA~5~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296456	11/12/2007	UT	3.0	3		M	11/12/2007	Painful at injection site.  Site is red and swollen.				Y						11/07/2007	11/08/2007	1	N/A	PVT	UNK		None	None			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2504AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296457	11/12/2007	WA	25.0	25		F	11/12/2007	Fluzone 0.5ml IM left deltoid on Sat 11/10/07. Pt called Sunday afternoon to say she had a rash over arms, body, legs (thighs) and stomach. She had taken Benadryl 50mg Q4h but the rash has not subsided.										11/10/2007	11/11/2007	1		OTH	OTH		None	Not known			1						1	Rash generalised	FLU3~SANOFI PASTEUR~U2515AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296458	11/12/2007	MN	38.0	38		F	11/12/2007	Fever 104, chills, vomiting, diarrhea, weakness.				Y					N	11/08/2007	11/09/2007	1		PVT	OTH	Tylenol Extra strength, albuterol, Astelin, Baclofen, Calcium + D, Vitamin D, Clonazepam, Advair Diskus, Bactroban, Protonix, Prednisone, Lyrica, Imitrex, Ultram, Trazodone, Nasacort AQ		Irritable bowel syndrome, esophageal reflux, diarrhea, intestinal nonabsorb postop, migraine, abnormal reflex, health care directive, pernicious anemia, Hx of tobacco use, Disturbance of skin sensation.	diarrhea~Influenza (Seasonal) (no brand name)~2~37.00~In Patient		1						1	Asthenia; Chills; Diarrhoea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2493AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296459	11/12/2007	MD	2.0	2	.4	M	11/12/2007	Pt. in office on 11/9, received flu vaccine.  We then realized pt. already received flu vaccine on 10/19/07.  There were no adverse reactions per mom.									Y	11/09/2007	11/09/2007	0	None	PUB	PUB	None	None	None			1						1	Inappropriate schedule of drug administration; Medication error	FLU3~SANOFI PASTEUR~UT2460BA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296461	11/12/2007	NY	62.0	62		M	11/11/2007	Patient given wrong dose (1 cc given).									Y	11/06/2007			None	OTH	OTH	None	None	None			1						1	Incorrect dose administered; Medication error	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80686~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0296462	11/12/2007	NY	49.0	49		M	11/11/2007	Patient given wrong dose (1 cc given).  Reported slight Lt deltoid soreness 5 hrs after injection.									Y	11/06/2007			None	OTH	OTH	None	None	None			1						1	Incorrect dose administered; Injection site pain; Medication error	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80686~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0296463	11/12/2007	NY	50.0	50		F	11/11/2007	Patient given wrong dose (1 cc given).									Y	11/06/2007			None	OTH	OTH	None	None	None			1						1	Incorrect dose administered; Medication error	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80686~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0296464	11/12/2007	NY	45.0	45		F	11/11/2007	Patient given wrong dose (1 cc given).									Y	11/06/2007			None	OTH	OTH	None	None	None			1						1	Incorrect dose administered; Medication error	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80686~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0296465	11/12/2007	NY	42.0	42		F	11/11/2007	Patient given wrong dose (1 cc given).									Y	11/06/2007			None	OTH	OTH	None	None	None			1						1	Incorrect dose administered; Medication error	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80686~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0296466	11/12/2007	NY	47.0	47		M	11/11/2007	Patient given wrong dose (1 cc given).									Y	11/06/2007			None	OTH	OTH	None	None	None			1						1	Incorrect dose administered; Medication error	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80686~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0296467	11/12/2007	NY	37.0	37		M	11/11/2007	Patient given wrong dose (1 cc given).									Y	11/06/2007			None	OTH	OTH	None	None	None			1						1	Incorrect dose administered; Medication error	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80686~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0296468	11/12/2007	NY	54.0	54		F	11/11/2007	Patient given wrong dose (1 cc given).									Y	11/06/2007			None	OTH	OTH	None	None	None			1						1	Incorrect dose administered; Medication error	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80686~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0296469	11/12/2007	NY	42.0	42		M	11/11/2007	Patient given wrong dose (1 cc given).									Y	11/06/2007			None	OTH	OTH	None	None	None			1						1	Incorrect dose administered; Medication error	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80686~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0296470	11/12/2007	TX	3.0	3		M	11/12/2007	Pt had rash all over face and abdomen.  No swelling or trouble breathing.  Gave Benadryl in the office and he improved.									Y	10/29/2007	10/29/2007	0		PVT	PUB		None	NKA			1						1	Rash	FLU3~SANOFI PASTEUR~UT2456AA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB182AA~2~UN~RL~HEP A (HAVRIX)~1	USA		Influenza
0296471	11/12/2007	NE	35.0	35		F	11/12/2007	11/2/07: general malaise, myalgia, sinus, hoarseness, dizziness.  11/12/07: Hoarseness, dizziness, general malaise, resolving, still some myalgia.									Y	10/31/2007	11/02/2007	2	None	PVT	OTH	None	None	PCN			1						1	Dizziness; Dysphonia; Malaise; Myalgia; Sinus disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU310AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296472	11/12/2007	NY	36.0	36		F	11/09/2007	On 11/2/07 in early afternoon felt fatigued, flushed, developed headache, had severe chills, skin hurt to touch.  Took Tylenol that evening, continued Tylenol on regular basis.  Symptoms continued until PID appt on 11/5/07.  Started taking ibuprofen BID that evening 11/9/07 feeling some better, no HA, no chills, still feels fatigued.  Plans to follow up with MD next week if not feeling 100%.									Y	11/02/2007	11/02/2007	0	None	UNK	UNK	none	no	? allergy to epinephrine, previously treated for GERD			1						1	Chills; Fatigue; Flushing; Headache; Skin discomfort	FLU3~SANOFI PASTEUR~U2467AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296473	11/12/2007					U		None stated									U	11/01/2007	11/02/2007	1		UNK	UNK		Not aware of any.	None			1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA317BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296474	11/12/2007	NY	34.0	34		F	11/07/2007	Day after injection (Oct 20), itching back of head, top of ears itchy & warm like on fire.  Persisted 4 days.  Then noticed swollen glands Tuesday (Oct 23rd) after injection.  10/26-Noticed rash on chest that itched.  Took Benadryl 50 mg q hrs x3 nights.  10/29-At 22OD, rash on arms & trunk noticed with urticaria.  Went to ECC.  Taken out of work 30th & 31st.  Own MD started patient on Prednisone pack with declining doses & XYZ.  Recovered by Nov 5th & returned to work 11/6.				Y					Y	10/19/2007	10/20/2007	1		UNK	UNK	None	None	None			1						1	Activities of daily living impaired; Lymphadenopathy; Pruritus; Rash; Skin warm; Urticaria	FLU3~SANOFI PASTEUR~U2467AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296475	11/12/2007	NY	50.0	50		F	11/07/2007	At 0300 (4 hrs post injection) arm red, hot to touch, achy.  2-3 days after injection SOB upon ambulating, all joints stiff, and rash appeared (raised and itchy on trunk of body), went to MD on day 3 after work.  Put on tapering dose of Prednisone for total of 12 days.  Within 2 days of starting Predisone, patient felt better.  Had F/u appt twice that week.  Next F/u 11/28/07.  Recovered 2 wks post injection (missed work).				Y					Y	10/19/2007	10/20/2007	1	None	UNK	UNK	Avapro 300 mg daily, Zoloft 25 mg daily	None	latex allergy, HTN			1						1	Activities of daily living impaired; Dyspnoea; Erythema; Joint stiffness; Pain; Rash; Rash pruritic; Skin warm	FLU3~SANOFI PASTEUR~U2467AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296477	11/12/2007	AK	57.0	57		F	11/12/2007	Unable to use shoulder with full range without causing severe pain.									U	10/17/2007	10/18/2007	1		OTH	PVT	unknown					1						1	Mobility decreased; Musculoskeletal pain	FLU3~SANOFI PASTEUR~U2515AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296480	11/12/2007	NM	1.0	1	.0	F	11/12/2007	Swelling & pain both thighs in 24hr after immunization.  Refusing to stand, improved over 4 days.									Y	11/07/2007	11/07/2007	0	X-ray lower extremities OK	PVT	OTH		No-on Amox for OM, doing well	No			1						1	Gait disturbance; Injection site pain; Injection site swelling; X-ray limb normal	FLU3~SANOFI PASTEUR~UI2459MA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1273F~3~UN~RL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0183U~1~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08700C~4~UN~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0645U~1~UN~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0296481	11/12/2007	MO	16.0	16		M	11/12/2007	Nausea, R arm hurts, fever 100.4 degrees, headache, stomach ache.  WBC elevated.  Rociphin injection given x3 and CBC with diff. requested.									Y	11/05/2007	11/07/2007	2	11-7-07, WBC, 21,250; 11-8-07, WBC, 15,850; 11-9-07, WBC, 6,600; CBC with diff	PVT	PVT	Clarinex, Astelin spray	URI, L shoulder muscle strain	None			1						1	Abdominal pain upper; Full blood count; Headache; Nausea; Pain in extremity; Pyrexia; White blood cell count increased	FLU3~SANOFI PASTEUR~U2445AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2379BA~1~UN~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PPV~MERCK & CO. INC.~09620~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296482	11/12/2007	WI	21.0	21		F	11/07/2007	None Stated									Y	10/30/2007	10/31/2007	1		OTH	UNK						1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA2966A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296483	11/12/2007	WI	40.0	40		F	11/07/2007	Red, Burning, itching; Benadryl - Still have intermitted burning and tingling									N	10/29/2007	10/30/2007	1	none	OTH	OTH	none	none				1						1	Burning sensation; Erythema; Paraesthesia; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA296GA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296484	11/12/2007	PA	50.0	50		F	11/12/2007	10/26/07-Headache, soreness, tingling down L upper arm.  11-2-07 Tingling, stinging sensation L shoulder/neck.  11-3-07 Tingling, stinging L side face.  Sensation moved 11-5-07 to R side face.  Headache continues.				Y					N	10/26/2007	10/26/2007	0	None	PUB	PVT			latex allergies, allergy-Pyridium plus, Cetacaine, fruits & pits	facial droop~Vaccine not specified (no brand name)~UN~0.00~In Sibling		1						1	Headache; Myalgia; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U2529AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296509	11/13/2007	CA	52.0	52		F	11/13/2007	FEVER, NAUSEA, BODY ACHES, HEADACHES, EXTREME CHILLS, NO APPETITE, EXTREME FATIGUE, UPPER RESPIRATORY PROBLEMS, POSSIBLY PNEUMONIA, WILL SEE TOMORROW.				Y					N	10/26/2007	10/29/2007	3	I HAVE TRIED TO FIGHT THIS OFF THINKING IT IS THE FLU, BUT I AM VERY SICK AND SCHEDULED FOR DR APPT IN THE MORNING! I CANNOT GET OVER WHATEVER THIS IS THAT HAPPENED AFTER I TOOK THE SHOT.	PVT	PVT	LUNESTA, INDERAL, XANAX	NONE	ALLERGY TO SULPHA, AND CRAB MEAT. NO CONDITION EXCEPT FOR HIGH BLOOD PRESSURE UNDER CONTROL			1						1	Anorexia; Chills; Fatigue; Headache; Nausea; Pain; Pyrexia; Respiratory disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0296510	11/13/2007	MO	36.0	36		F	11/13/2007	Sore arm, headache									Y	11/05/2007	11/05/2007	0		UNK	PVT						1						1	Headache; Pain in extremity	FLU3~SANOFI PASTEUR~02488AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296512	11/13/2007	MI	40.0	40		M	11/13/2007	Client reports receiving a flu and pneumonia shot in the left arm.  A few hours after receiving the injection didn't feel well.  Next morning he had difficulty getting up, took about two hours to get going.  Went to the nurse at work and she gave advice, he decided to go to a doctor; the doctor looked at his arm and sent him to emergency.  Emergency doctor told him he had cellulitis, prescribed pain medication and antibiotics.  Slowly getting better.  Arm remains red and with some swelling.				Y					N	10/29/2007	10/29/2007	0		UNK	PVT	None	Denies	Denies			1						1	Cellulitis; Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~U2451AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0061U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0296513	11/13/2007	MO	61.0	61		F	11/13/2007	High fever 102-103 for two days, arm swollen and very sore, swelling underarm for 3 days									Y	11/05/2007	11/05/2007	0		UNK	PVT	Synthroid	NONE				1						1	Oedema peripheral; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~02488AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0963U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296515	11/13/2007	NV	59.0	59		F	11/07/2007	Pt. complains of soreness in arm daily ever since the shot was administered, about 2 weeks now. Patient had taken Lortab with no relief. And she is unable to take ASA or NSAIDs per patient. Told to follow up with MD									U	10/18/2007	10/19/2007	1		UNK	PVT	Simvastatin					1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2504AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296516	11/13/2007	MA	29.0	29		F	11/13/2007	Patient developed erythemic nodule 6 cm in diameter at site of injection (left deltoid). No treatment was requested/required. Resolving at time of assessment (48 hours post-injection).									Y	11/07/2007	11/07/2007	0		MIL	MIL	Prenatal vitamins	None				1						1	Injection site erythema; Injection site nodule	FLU3~SANOFI PASTEUR~U2524AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296517	11/13/2007	SC	7.0	7		F	11/13/2007	Patient went to Doctors office for seven year well visit. Patient was healthy with no symptons of cold or flu.  Flu shot was offered and given to patient. Patient developed cold and flu like symptons overnight and begin weezing. The following day went back to doctor and he prescribed pulmicort and Xopenex to help with the viral induced asthma. Overnight developed pain in joints.  Went back on third day and treated joint pain with Motrin. Ashtma cleared after two weeks of treatments of pulmicort and Xopenex. Each time patient gets a cold, an asthma attack occurs and breathing treatments are given (pulmicort and xopenex.)  The patient never had asthma or any related symptons prior to the flu shot.				Y					N	12/21/2004	12/22/2004	1		PVT	PVT		Well Visit check up	None	Viral Induced Asthma~Influenza (Seasonal) (no brand name)~3~7.00~In Patient		1						1	Arthralgia; Asthma; Influenza like illness; Nasopharyngitis; Wheezing	FLUX~UNKNOWN MANUFACTURER~U1516AA~1~ID~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0296518	11/13/2007	IL	67.0	67		F	11/13/2007	Received flu injection 10/10/2007 Skin eruption occured five days later starting with right shoulder and extending over trunk area. Saw PA and then was seeen by Dr.  Received steroids and said MD called it a drug eruption. Person is on Attenolol,Norvasc, HCTZ, K+,Evista,Lasix,Zedia with no prior problems				Y					Y	10/10/2007	10/15/2007	5	Stated she had a pathology test	UNK	UNK						1						1	Rash; Biopsy; Biopsy skin; Dry skin; Rash; Rash macular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80432~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0296519	11/13/2007	MO	48.0	48		F	11/13/2007	Ached all over for 2 days. Tenderness in the area. Very swollen under the armpit for 24 hours-difficult to bathe that evening very uncomfortable through the next day. Never had a rash on the affected arm. Felt more comfortable after 48 hours.									Y	11/05/2007	11/05/2007	0		UNK	PVT						1						1	Injection site pain; Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~02488AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0963U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296520	11/13/2007	TX	71.0	71		F	11/13/2007	APPROXIMATELY 4-5 HRS. AFTER FLU VACCINE GIVEN DEVELOPED A RASH ON NECK, BOTH ARMS,AND UPPER TRUNK. DESCRIBED AS DIFFUSE AND LIKE MOSQUITO BITES.  ITCHING TREATED WITH BENADRYL 50 MG P.O. X ONE DOSE, AND ITCHING RESOLVED  PER PHYSICIAN ADVISE TAKING CLARITIN 10 MG EVERY 12 HRS TO RELIEVE RASH.  RASH RESOLVED AFTER 3 DAYS TREATMENT WITH CLARITIN.									Y	11/06/2007	11/06/2007	0		PUB	PVT						1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U2479BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296521	11/13/2007	NC	5.0	5		M	11/13/2007	Itching and bumps/hives at injection site.  Injection was given on a Tues, rash showed on Sat., then again the next Tues (one week after injection).  Treated with Benedryl and hydrocortizone cream.									Y	11/06/2007	11/10/2007	4		UNK	PVT	None	None	None			1						1	Injection site pruritus; Injection site urticaria; Rash	FLUX~UNKNOWN MANUFACTURER~UN~2~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296522	11/13/2007	MA	79.0	79		F	11/13/2007	Pt received flu shot at clinic in building.  The following day her daughter called the housing manager to report that the patient has dementia  and receives all her vaccines at the Program.  She stated that the patient had received her flu vaccine at the Program prior to the one received at the flu clinc held in the building. Daughter did not report any adverse events.									Y	11/08/2007	11/08/2007	0	none	UNK	UNK	unknown	noe reported	Daughter reported after the clinic that the patient has dementia.			1						1	Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA05AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0296525	11/13/2007	TX	73.0	73		M	11/13/2007	FLU SHOT ADMINISTERED IN LEFT ARM. PNEUMONIA SHOT ADMINISTERED IN RIGHT ARM. IT WAS THE RIGHT ARM (PNEUMONIA) WHICH WAS AFFLICTED. FROM RIGHT SHOULDER DOWN THROUGH RIGHT ARM TURNED RED AND WAS TENDER/BURNED. PATIENT FELT SICK AND SAID BONES ACHED ALL NIGHT. PATIENT FELT THIS WAY THURSDAY NIGHT THROUGH SUNDAY AFTERNOON, AT WHICH TIME ALL SYMPTOMS RESOLVED AND PATIENT FELT FINE. PATIENT REPORTED THIS TO PHARMACIST TUESDAY AFTERNOON.									Y	11/08/2007	11/08/2007	0	NONE PERFORMED. PATIENT DID NOT SEEK MEDICAL INTERVENTION.	UNK	PUB	LEXAPRO 10MG QD; ZOCOR 20MG QD; ESTAZOLAM 2MG HSprn; VICODIN 5/500 PRN	NONE NOTED	PENICILLIN; SULFA			1						1	Bone pain; Burning sensation; Erythema; Malaise; Pain; Tenderness	FLU3~SANOFI PASTEUR~U2499AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1035F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296526	11/13/2007	WA	39.0	39		F	11/13/2007	11.09.07 12:30pm soreness, redness, swelling, hot where the shot was given, headaches;       11.10.07 am where the shot was given Skin irritation growth up to 3 x 3 cm and very hard, headaches, hot feeling, redness on skin of head and dekolte, light flu like symptoms - 4:00 pm weakness;                                   11.11.07 same symptoms as day before,where the shot was given Skin irritation growth up to 5 x 5 cm and very hot and hard, pm hives, strong flu like symptoms, 8:30 pm dizziness for about 5 minutes, nearly felt down;                 11.12.07 same symptoms but less then the day before, no dizziness, pm - skin irritation shrinks and is less red and hot;                       11.13.07 skin irritation nearly gone , not red and not hot, not hard anymore, hives, light flu like symptoms - feel much better.                   From 11.09.07 until 11.12.07 4 times a day 400mg Paracetamol, 300mg Ascorbinsäure, 50mg Coffein, 5mg Chlorphenaminhydrogenmaleat, 1 once a day, 1000mg Vitamin C, 35 drops of Umckaloabo = Perlargonium reniforme/sidoides 80,0g;     11.13.07   2 times a day 400mg Paracetamol, 300mg Ascorbinsäure, 50mg Coffein, 5mg Chlorphenaminhydrogenmaleat,                      1 once a day, 1000mg Vitamin C, 35 drops of Umckaloabo = Perlargonium reniforme/sidoides 80,0g.									Y	11/09/2007	11/10/2007	1		PVT	UNK			Nickel allergie			1						1	Asthenia; Dizziness; Erythema; Feeling hot; Headache; Influenza like illness; Injection site erythema; Injection site induration; Injection site pain; Injection site swelling; Injection site warmth; Skin irritation	FLU3~SANOFI PASTEUR~U2515AA 6.30.08~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296546	11/13/2007	MI	4.0	4		M	10/31/2007	Grand mal seizure-pt home approx 12-13 hrs after immunizations IV Diazepam given.  12/07/2007 ER report received for DOS 10/26/07 with Final DX:  First time seizures.  Pt developed seizure at home described as whole body shaking and eye rolling with perioral cyanosis on pm of vax.  PE WNL except for (+) irritability.  Observed for 23 hrs and D/c.					Y	1			Y	10/25/2007	10/30/2007	5	Electrolytes, Ca, Mg, P-Normal EEG. Labs and Diagnostics:  EEG abnormal	PVT	PVT	Singulair 4 mg	No	No allergies-Developmental Delay-Asthma Hirschsprings Disease. PMH:  Hirschsprung's disease.  Cerebral Palsy.  Developmental delay.  NKDA.			1						1	Blood calcium normal; Blood electrolytes normal; Blood magnesium normal; Grand mal convulsion	FLU3~SANOFI PASTEUR~U2494AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A02732~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~0545U~2~SC~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Hospitalisation	Influenza
0296547	11/13/2007	MN	83.0	83		F	11/09/2007	Pt developed confusion, apasia 3 days after flu shot. Was hospitalized for 4 days with negative w/up-diagnosis was encephalopathy possibly due to flu shot 12/26/07-records received for DOS 10/7-10/12/07-Metabolic encephalopathy of unknown case as well as some underlying dementia. Presented to ED with confusion which started day before. Difficulty with finding words and not completely making sense. Speech garbled.  On date of admission unable to walk. Fever.				Y	Y	5			Y	10/04/2007	10/07/2007	3	cultures neg, MRI/A CT scan of brain neg, blood urine and neck was EEG neg 12/26/07-records received-Elevated digoxin level 2.3. CT scan negative. Urinalysis negative, urine culture negative. BUN increased.	PVT	PVT	Aspirin, Digitek, Lasix, Levothyroxine Sodium, Potassium Chloride, Toprol XL	No	HTN, Atrial fibrillation, Benign Essential Hypertension, Hydronephrosis, Hyperlipidemia, Hypothyroidism, Ischemic Stroke 12/26/07-records received-PMH: history of CVA, multiple. hypertension. hypothyroidism, hypercholesteolemia, history atrial fibrillation, congestive heart failure.			1						1	Aphasia; Blood culture negative; Computerised tomogram normal; Confusional state; Culture urine negative; Electroencephalogram normal; Encephalopathy; Nuclear magnetic resonance imaging brain normal; Nuclear magnetic resonance imaging normal	FLU3~SANOFI PASTEUR~U2457EA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0296550	11/13/2007	MI	10.0	10		F	11/13/2007	Two days after, flumist was administrated pt developed fever, nasal congestion, cough and wheezing. Symptoms lasted for 4 days. Pt then came to office to be seen. Pt had cbc which was normal. Albtuerol neb x 2 where given. Pt continued to wheeze. Was sent home on albtuerol and pulmicort.				Y					U	11/08/2007	11/10/2007	2	cbc, nebulizer	PVT	UNK	None	None	Hypercholesterolemia, Asthma, Allergic Rhinitis			1						1	Cough; Full blood count; Nasal congestion; Pyrexia; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500497P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0296551	11/13/2007	DE	44.0	44		M	11/13/2007	Member is experiencing redness, swelling, intermittent light sensitivity, and blurred vision in LEFT eye approx 9 hours after vaccination. Treatment to date includes opthalmic antibiotics and steriod drops (G.E. Polymyxin B/TMP and Tobradex).				Y					N	11/03/2007	11/03/2007	0	IOC testing performed as well as dialation.	MIL	MIL		Eye eas red the week prior but had cleared up 2 days prior to vaccination.				1						1	Erythema; Mydriasis; Photophobia; Swelling; Vision blurred	ANTH~EMERGENT BIOSOLUTIONS~FAV111~6~IM~RA~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500496P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0296553	11/13/2007	WI	16.0	16		F	11/13/2007	No adverse events. Adult dose given to 16 year old.									Y	11/06/2007	11/06/2007	0	None	PUB	PVT		None				1						1	Incorrect dose administered; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA026AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0296555	11/13/2007	CO	12.0	12		F	11/13/2007	Client had flu symptoms approximately 2 weeks after the Flu Mist administration, and has continued with these to the present.  Is being treated by the primary physican with Tamiflu.				Y					U	10/27/2007	11/08/2007	12		UNK	PVT	None	None Reported	None noted per mother's hx			1						1	Influenza	FLUN3~MEDIMMUNE VACCINES, INC.~500489P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0296557	11/13/2007	VA	39.0	39		M	11/13/2007	11/1/07. Initially had lower back pain and left arm pain. Following day low-grade fevers and chills x 24 hrs followed by pain/weakness in both thighs interfering with walking and achy, sharp pain in both forearms with bilateral hand weakness. Muscle weakness and pain interfered with his ability to walk, climb stairs, brush teeth, open a can, button a shirt and writing. No double vision, chewing difficulty, swallowing or shortness of breath. Muscle weakness and pain progressed. Saw PCP 11/5/07 who referred patient to neurologist r/o Guillain-Barre syndrome secondary to influenza vaccine. 11/6/07 evaluated by Neurologist who concluded patients' clinical presentation and EPS findings (Needle EMG & Nerve Conduction)are suggestive of AIDP aka Guillain-Barre Syndrome. Neurologist recommended outpatient IVIG therapy, serum testing for Lyme titers, TSH, Campylobacter jejuni titers, vitamin B12 level and IgA level. After IVIG therapy, Physical Therapy for muscle strengthening and gait training is recommended.  11/14/2007 296557 -per nurse- pt has received flu vax for the past 5yrs with no reaction. Used different manufacturer this year. 11/19/2007 MR received from neurologist for OV of 11/06/2007.  Pt presented with progressive muscle weakness x 3 days.  Pt first noted back pain and L arm pain with low grade fever and chills.  Pt then noted pain in thighs which interfered with walking and ability to climb stairs.  Achy sharp pain noted in forearms and weakness in hands bilat.  Difficulty with ADLs noted.  PE (+) for muscle weaknes in extremities bilat.  DTRs are decreased in arms and legs.  Sensation decreased in stocking-glove distribution bilat.  Mild walking difficulty. Txd with IVIG, PT and gait training. DX: Guillain-Barre Syndrome (AIDP). 1/19/2010 Able to ADL effortlessly. Continues to have muscles weakness and fatigue in legs and to lesser extent his arms.			Y						N	10/23/2007	11/01/2007	9	11/5/07 CBC with Differential, CMP with cGFR, TSH and Lipid Panel all normal. 11/6/07 Nerve Conduction Studies and Needle EMG suggestive of an acute peripheral neuropathy with predominant demyelinative involvement of the motor fibers in the proximal and distal muscles.  Labs and Diagnostics:  EMG reveals mild acute denervation in proximal and distal muscles.  NCS suggestive of acute peripheral neuropathy with predominant demyelinative involvement of motor fibers.  CK 310.  Borrelia burgdofii IGG (-) with Western Blot with 2 reactive bands. IGM (-).	UNK	UNK	NONE	None	Allergic to Sulfa medications; Hayfever. PMH:  stomach virus 10/2007.	None~ ()~~0.00~Patient|None~ ()~~0.00~Sibling|None~ ()~~0.00~Sibling		1						1	Back pain; Blood thyroid stimulating hormone normal; Chills; Electromyogram abnormal; Fatigue; Full blood count normal; Gait disturbance; Guillain-Barre syndrome; Immunoglobulins; Laboratory test normal; Lipids normal; Muscular weakness; Nerve conduction studies abnormal; Pain; Pain in extremity; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81270~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening	Influenza
0296559	11/13/2007	TX	49.0	49		F	11/13/2007	Localized pain, redness and swelling at injection site lasting 2 weeks. Presently still experiencing discomfort in the affected arm upon exertion. Using ibuprofen, cool compresses and avoiding muscle strain to minimize inflammation.									U	10/19/2007	10/19/2007	0		PUB	PVT						1						1	Cold compress therapy; Inflammation; Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2510AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296560	11/13/2007	VA	62.0	62		F	11/13/2007	Injection site reaction- swelling, erythema, tenderness, warmth				Y					U	11/12/2007	11/12/2007	0	Pt. had Pneumovax 1 year prior on 11/2/06 and was inadvertanly vaccinated again.	PVT	PVT						1						1	Inappropriate schedule of drug administration; Injection site erythema; Injection site pain; Injection site reaction; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79241~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~3080U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0296562	11/13/2007	CA	50.0	50		F	11/13/2007	severe vomiting, diahrea, hallucinations, screaming, swelling of the brain, perforated ear drums, blood in ears, headache, weakness, heart palpations, dizziness, eyes sensitive to light, encephilitis, chills,severe shaking started approximately six hours after vaccine and some symptoms still continuing. 11/26/07-records received for DOS 10/26-10/28/07-DC DX: acute coronary syndrome, myocardial infarction ruled out. Presented to ED with 1-2 day HX of intermittent chest pain radiating to her neck and left arm. Diaphoretic, slightly short of breath.					Y	2		Y	N	10/28/2007	10/29/2007	1	Dr. exam revealed perforated ear drums and verified allergic reaction to vaccine 11/26/07-records received- EKG minor ST-T depression no ST elevation. First degree AV block. Cariac enzymes negative. Angiogram did not reveal any significant disease except small vessel disease. CRP normal. Sonogram of gallbladder normal.	UNK	UNK	none	entered hospital for chest pain diagnosed with angina	allegic to sulfa drugs, phenergan,NSAIDs 11/26/07-records received-PMH: Myocardial infarction. Hyperlipidemia.			1						1	Asthenia; Brain oedema; Chills; Diarrhoea; Dizziness; Encephalitis; Hallucination; Headache; Hypersensitivity; Palpitations; Photophobia; Screaming; Tremor; Tympanic membrane perforation; Vomiting	FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~GM~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0296564	11/13/2007	UT	60.0	60		M	11/13/2007	pt recieved influenza and pneumonia vaccine on 11/12/07. Pneumonia was administered in right deltoid muscle. Wife called on 11/13/07 & stated pts right arm was sore, red & inflammed and was also complaining of headache. She stated symptoms began last night and that patient did not sleep during the night. Wife was advised to give acetaminaphen or ibuprofen for discomfort. Also to treat injection site with warm compresses and give diphenhyramine to help relieve symptoms. Follow up at 5:00pm 11/13 patient was doing better, headache was gone and redness on arm was clearing.									Y	11/12/2007	11/12/2007	0		UNK	PVT	Unknown	none	Unknown			1						1	Erythema; Headache; Inflammation; Limb discomfort; Sleep disorder	FLU3~SANOFI PASTEUR~U2454AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0061U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296566	11/13/2007	VA	60.0	60		F	11/13/2007	Hive at the site of injection, high fever, sleepy,nauseated. Started evening of injection and became worse for 3 days. Used ice paks and rest and took tylenol.									Y	11/05/2007	11/05/2007	0	none	UNK	PVT	lisinopril,l-thyrovine,nexium,triamterene hctz,pot chlor er,nabumetone,aspirin,multi vitamin	none	seafood,high blood pressure,arthritis,thyroid, acid reflux			1						1	Injection site urticaria; Nausea; Pyrexia; Somnolence	FLU3~CSL LIMITED~303BA~UNK~UN~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~OV38U~3~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296567	11/13/2007	ID	62.0	62		F	11/13/2007	Had shingles vaccine shot at noon on Friday. Sunday evening noticed lots of red blotches on upper torso on left side,under arm, on breast and on front of both thighs, with a few red spots spread a little on the right shoulder and legs. Monday morning around 9:00 AM, left side of face and cheek was swollen and the red blotches were not raised welts. By 10:00 AM, upper lip was beginning to swell and by 11:00 was completely swollen over the lower lip. I had no problem with my throat or breathing. Went to an emergency clinic nearby to see the on-call doctor and he gave me a claritan pill and a prescription for a steroid, Prednisone. I took the first steroid pill at 1:00 PM and by evening the swelling was starting to go down.  Tuesday morning the swelling was almost completely gone and the red welts were pretty much gone. I took the second steroid pill and by afternoon I was pretty well cleared up. The doctor called the State Epidemiologist and felt that the reaction appeared to be a result of the shingles vaccine I had gotten Since I had had no change in my regular medications that I take for the last five years. He was just surprised that the reaction did not occur closer to the time I had the shot.									Y	11/09/2007	11/11/2007	2	None	PUB	PVT	Zocor, Quinapril, HCTZ, Synthroid, Prometrium, Premarin	None	High Blood pressure and thyroid	None~ ()~NULL~~In Patient|None~ ()~NULL~~In Sibling1|None~ ()~NULL~~In Sibling2		1						1	Erythema; Lip swelling; Rash; Rash macular; Swelling face; Urticaria; Vaccination complication	FLUX~UNKNOWN MANUFACTURER~~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPAB~UNKNOWN MANUFACTURER~~1~~RA~HEP A + HEP B (NO BRAND NAME)~1|VARZOS~UNKNOWN MANUFACTURER~~1~~LA~ZOSTER (NO BRAND NAME)~1	USA		Influenza
0296568	11/13/2007	KY	1.06	1	.1	M	11/13/2007	Patient received his shots on Oct. 12, 2007. On Oct. 30, 2007 my husband and I noticed that he had a bruise and could not figure out how he got it. Then the next morning he had petechiae on his feet and legs.He also got another bruise between that night and morning. We took him to see Dr. He sent us to the Lab to get A CBC. His platelets were 6. He then called the Hospital and they told us to bring him on down there. 11/30/07-records received for DOS 10/31-11/207 and 11/4-11/6/07-DC DX: for both admissions:Idiopathic thrombocytopenic purpura. Anemia and Acute otitis media. Admitted for increasing bruising and low platelets. Increased bruising noted past 2 days. Prior to second admission fussy and pulling at his eat. Treated with WinRho and IVIG.					Y	4			U	10/12/2007	10/31/2007	19	On 10-31-2007 his Platelet count was 6. While at they done lab work 11-02-2007 his platelets were 8. Then on 11-04-2007 his platelets were 6 again. On 11-06-2007 after IVIG his platelets were 51. Then on 11-08-2007 they were 293. He has to have more labs on 11-15-2007. He was diagnosed with Immune Thrombocytopenia Purpura. 11/30/07-records received-WBC 15.8, lymphocyte 65. Platelets 6000. On second admission platelets 5000.	UNK	UNK	Dimeatapp for a cold.	He had a cold 11/30/07-records received- Mild upper respiratory symptoms 2 weeks ago.	Heart Mumor			1						1	Idiopathic thrombocytopenic purpura; Immunoglobulins; Petechiae; Platelet count decreased	FLUX~UNKNOWN MANUFACTURER~~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~1~UN~RL~HEP A (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~1~UN~LA~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~1~UN~RA~VARICELLA (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0296571	11/13/2007	WA	58.0	58		F	11/05/2007	Onset of fever, chills, myalgia on 11/3/07 at approx. 11:00am.  Left upper arm painful, red & swollen.  Ibuprofen 400 mg prn fever, myalgias & hot packs to area.  Rociphin 1000 mg IM on 11-5-07, Bactrim DS 900 mg BID x10 days.				Y					U	11/03/2007	11/03/2007	0		PVT	PVT	Strattera, Zoloft, Premarin, Lamictal, Seroquel, ibuprofen prn	None	ASA, codeine, morphine, Darvon, Demerol, Tolectin			1						1	Chills; Injection site erythema; Injection site pain; Injection site swelling; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U2512AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0963U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0296573	11/13/2007	NJ	35.0	35		F	11/13/2007	Area around injection site swelling up, was red & hot & tense posteriorly as well as anteriorly.									Y	09/25/2007	09/26/2007	1	X-ray R humerus, elbow, hand, all negative	PVT	OTH	Zoloft once daily, Xanax 0.2 prn, Zyrtec QD	None	Levaquin-dizziness/nausea			1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth; X-ray limb; X-ray normal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80432~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0926U~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296575	11/13/2007	CA	38.0	38		M	11/13/2007	Throat, mouth, and tongue swelled.  Took 2 Benadryl 50 mg total.									Y	11/08/2007	11/08/2007	0	none	PVT	OTH	Benadryl 50 mg po x1	none	none			1						1	Oedema mouth; Pharyngeal oedema; Swollen tongue	FLU3~SANOFI PASTEUR~C2512AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2842AA~1~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0296576	11/13/2007	ID	18.0	18		F	11/13/2007	1/2 hour post-vaccination 0340-0410 headache, sore throat, sore ears, chills.  FU 0500 dizzy, headache, no sore throat/ears/chills.  Is recovering.									N	11/13/2007	11/13/2007	0		OTH	PVT	None	None	Asthma, anemic			1						1	Chills; Dizziness; Ear pain; Headache; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U2575AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296577	11/13/2007	CA	62.0	62		M	11/13/2007	Left forearm blisters (3), swelling, red areas-skin.									N	11/08/2007	11/11/2007	3	None	PVT	PVT	Flomax, Lisinop., Lunesta, Viagra, Hydrocor., Wellbutrin, Diazepam	None	None	None~ ()~~0.00~In Patient|None~ ()~~0.00~In Sibling|None~ ()~~0.00~In Sibling		1						1	Blister; Erythema; Oedema peripheral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA066AA~2~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|VARZOS~MERCK & CO. INC.~1088U~2~UN~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0296578	11/13/2007	WA	43.0	43		M	11/12/2007	Patient is experiencing numbness from tip of thumb to forefinger of left hand (vaccine was administered to left arm).									U	11/02/2007	11/08/2007	6		OTH	PVT	None	None	None			1						1	Hypoaesthesia	FLU3~SANOFI PASTEUR~U2523AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296579	11/13/2007	CA	30.0	30		F	11/13/2007	10 minutes after vaccinated c/o large swelling at RD (injection site), hives spread to RLE, LUE, c/o itching all over body, c/o HA, pale and coughing.  Called 911, epinephrine 1:1000 (1/2 cc IM at LD), transferred to ER.				Y					Y	11/11/2007	11/11/2007	0	UNK	OTH	UNK	None	None	Asthma			1						1	Cough; Headache; Injection site swelling; Pallor; Pruritus generalised; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79489~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0296582	11/13/2007	TX	50.0	50		F	11/13/2007	Red, painful & itchy injection sites that has continued for several days.									U	11/08/2007	11/09/2007	1		OTH	PVT						1						1	Injection site erythema; Injection site pain; Injection site pruritus	FLU3~SANOFI PASTEUR~U2499AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296583	11/13/2007	VA	3.0	3		M	11/13/2007	Hurting within couple of hours of injection, could not walk, seen in office 11/12/07.  Lt swollen to just below knee/tense, warm on L lateral quadrant, below inj. site.  Red-felt to be allergic phenomenon.									Y	11/10/2007	11/30/2007	20	none	PVT	PVT		none	none			1						1	Abasia; Hypersensitivity; Injection site erythema; Injection site induration; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2500AA~6~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296584	11/13/2007	CA	34.0	34		M	11/01/2007	Immediately after flu shot , felt lightheaded then headache and nauseous Headache and nausea persisted for about 4 hrs until had felt good and next.									Y	11/01/2007	11/01/2007	0	nurse taken pulse and blood pressure. Results normal.	OTH	OTH		None	Pollen, bee stings			1						1	Blood pressure normal; Dizziness; Headache; Heart rate normal; Immediate post-injection reaction; Nausea	FLU3~SANOFI PASTEUR~U2449AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296585	11/13/2007	CA				F	11/12/2007	Dizzy, head felt really heavy - the rest of the night my arm where I got the shot started throbbing; Next day felt better but my arm was still throbbing									Y	11/01/2007	11/01/2007	0		OTH	PVT						1						1	Dizziness; Head discomfort; Injection site pain; Pain	FLU3~SANOFI PASTEUR~U2499AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296586	11/13/2007	IL	33.0	33		F	11/13/2007	Pt c/o chills, fever, nausea and dizziness/faint, total body aches about 5 hrs as described per patient.									Y	10/30/2007	10/31/2007	1		PUB	UNK						1						1	Chills; Dizziness; Nausea; Pain; Pyrexia; Syncope	FLU3~SANOFI PASTEUR~U2514AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296587	11/13/2007	NC	1.5	1	.5	F	11/06/2007	Had DTaP, Hib vaccines at left thigh on 11-1-07.  Patient came back to office 11-03-07 with area of redness 7 cm x 4 cm at area where injections given.				Y					Y	11/01/2007	11/02/2007	1		PVT	PVT		None	None		NC07113	1						1	Injection site erythema	DTAP~SANOFI PASTEUR~U2289AA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT2475AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0259U~3~IM~LL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B54007F~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0296588	11/13/2007	WI	9.0	9		F	11/12/2007	FluMist 11/8.  11/9 whole body rash, temp 101.8, puffy face, hands & feet.  11/11 temp 104 & continued rash.									Y	11/08/2007	11/09/2007	1	Will test for egg allergy.	PVT	PVT		None	None	None~ ()~~0.00~In Patient		1						1	Oedema peripheral; Pyrexia; Rash generalised; Swelling face	FLUN3~MEDIMMUNE VACCINES, INC.~500497P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0296589	11/13/2007	NE	45.0	45		F	11/12/2007	Within 8 minutes of the vaccination - throat muscles began clenching, sinuses became stuffy with some difficulty breathing, toes tingling, heart racing - Blood Pressure checked - 122/82. Took Benadryl - 3 doses through evening hours									Y	11/02/2007	11/02/2007	0	none	OTH	PVT	none	none	food and environmental - no meds.	no~ ()~~0.00~In Patient|no~ ()~~0.00~In Sibling|no~ ()~~0.00~In Sibling		1						1	Dyspnoea; Palpitations; Paraesthesia; Sinus congestion; Throat tightness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8007U~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0296590	11/13/2007	MI	65.0	65		M	11/05/2007	Swelling of right arm, pain.  Patient became lethargic.				Y					Y	10/17/2007	10/17/2007	0		PVT	UNK		None				1						1	Injection site pain; Injection site swelling; Lethargy	FLU3~SANOFI PASTEUR~U2505AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0061U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0296591	11/13/2007	NY	61.0	61		F	11/13/2007	Large right arm area swelling to elbow.  Pain into the hand.									Y	10/29/2007	10/31/2007	2		PVT	PVT	Ambien 10 mg, Patanol 0.1%		allergy to iodine, allergic rhinitis			1						1	Injection site pain; Injection site swelling; Pain in extremity	FLU3~SANOFI PASTEUR~U2529AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0200U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296592	11/13/2007	VA	26.0	26		M	11/13/2007	Within hours of receiving flu vaccine, patient began running a fever (up to 102 degrees F) and having muscle aches.				Y					N	11/09/2007	11/09/2007	0	CBC-WNL; CMP-pending	OTH	OTH	None	None	None known			1						1	Full blood count normal; Laboratory test; Myalgia; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80825~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0296593	11/13/2007	NC	60.0	60		F	11/21/2007	10-15-07 - Flu Shot - High School; 10-16-07 - Loss of strength in right arm, fingers tingly; 10-17-07 - Arm very achey. Went to Primary Care Doctor. If not better would make referral; 10-18-07 - Saw neurologist; 11-7-07 - EMG - neuralgic amypotrophy Parsonage Turner - Arm, shoulder hand, fingers right chest; EMG - 11-8-07 - Parsonage-Turner				Y					N	10/15/2007	10/16/2007	1	10-18-07 Neuralogic Exam; Tricep - loss of strength	OTH	PVT	actonel; zolpt; ambien (if needed)					1						1	Asthenia; Electromyogram abnormal; Neuralgic amyotrophy; Neurological examination abnormal; Pain in extremity; Paraesthesia	FLU3~SANOFI PASTEUR~U2508AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296594	11/13/2007	PA	28.0	28		F	11/04/2007	Severe flushing approximately 2 hours after shot given.  Lasted about 18 hours and no treatment necessary.									Y	11/03/2007	11/03/2007	0	None	PUB	PVT	Lo Ovral	None				1						1	Flushing	FLU3~SANOFI PASTEUR~U2493AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296596	11/13/2007	OH	37.0	37		F		Had shots about 4:15pm 10/31/07.  Had difficulty sleeping that night due to arm pain.  11/1-got up about 8am.  R delt very sore, felt hard when pushed arm.  Did some household chores, got a shower about 1:30pm.  When stepped out right delt-inner area slightly pink & very tender to touch.  At 2:30pm was seen by Dr. at clinic where I work.  He called it a large local hypersensitivity, told me to take Benadryl as directed, continue my Allegra & to use ibuprofen 600 mg Q 6 hrs.  On 11/2 at about 2pm Dr. re-evaluated my right upper arm. The pink area had increased to nearly wrapping the diameter of my arm, was warm to touch & still very painful in spite of doing as previously directed.  At this point the area was traced around, I was advised to continue with Benadryl & ibuprofen.  However he gave me a script for Keflex 500 mg once TID x10 days, told me if pink area continued over ink lines on 11/3 I was to start ATB.  I actually started Keflex about 6pm 11/2.  When I got home that night, the pink area had already moved beyond the pen lines in several directions, moving towards shoulder & elbow joints as well as completely wrapping around upper arm.				Y					Y	10/31/2007	11/01/2007	1	None	PVT	PVT	MVI, Aciphex, spironolactone, Allegra D24, Synthroid	None	Did have pneumovax in 2002 & did not have this bad of a reaction.  Allergies-Nubain, severe vomiting; phenobarbital, 3 days in coma.  Hx of esophageal varices & GI bleeding from them since age 2.  Had splenectomy with sphenorenal shunt 1978.	None~ ()~~0.00~In Patient		1						1	Hypersensitivity; Induration; Insomnia; Local reaction; Pain in extremity; Skin discolouration; Skin warm; Tenderness	FLU3~SANOFI PASTEUR~U22527AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0555U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0296597	11/13/2007	WY	66.0	66		M	11/01/2007	Nausea, vomiting, muscle aches approx 4 1/2 hrs. after receiving injection.  No SOB, no chest pain or wheezing.  Sx had passed by morning.									Y	10/31/2007	10/31/2007	0		PUB	PUB		None	None			1						1	Myalgia; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U2490AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296599	11/13/2007	VA	1.1	1	.1	F	11/06/2007	Mother called - c/o vomiting & increased fever since early am today (11-6-07).				Y					U	11/05/2007	11/06/2007	1		PUB	UNK		No				1						1	Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~UT2460AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296600	11/13/2007	WA	44.0	44		M	11/06/2007	Patient developed increasing muscle weakness and pain 2-5 days following vaccine making it difficult to walk, type, write, and perform daily activities. All labs were normal except for very elevated creatine kinase, myoglobim, and adolase. One week from vaccine, back to normal.				Y					Y	10/23/2007	10/25/2007	2	Creatine kinase > 730; Myoglobin > 200	PVT	UNK	None	None	None			1						1	Activities of daily living impaired; Blood creatine phosphokinase increased; Gait disturbance; Muscular weakness; Myalgia; Myoglobin blood increased	FLU3~SANOFI PASTEUR~U2458DA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296602	11/13/2007	MO	55.0	55		M	11/06/2007	Numbness L anterior chest.  Numbness/tingling R groin radiating down R inner thigh.  Intermittent onset night after vaccine.  BP 152/92.									U	10/30/2007	10/31/2007	1		PUB	PUB		None	Hx of high BP/stress			1						1	Hypoaesthesia; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80683~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0296603	11/13/2007	WI	58.0	58		F		The area ached, red, hot to the touch, swollen and a bump around the injection site that was about 2 1/2 inches long.									Y	11/01/2007	11/02/2007	1		PUB	OTH						1						1	Injection site erythema; Injection site mass; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2440AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0238279	11/14/2007	CT	80.0	80		M	11/28/2006	Initial (with VAERS reference # 238279) received on 23 November 2006 from CDC, who had received the report from patient in March 2005. An 81 year old male patient received on 10 November 2004 Fluzone (lot# U1479AA) and 2 days after developed an exacerbation of [[name]] Barren Syndrome as a severe reaction, with weakness throughout body. On November 15, 2004, the patient saw private medical doctor and was prescribed prednisone 60mg [for] one month. Hospital reports indicated that the patient had been on prednisone and tapered off his steroids by himself recently. The patient was admitted to a hospital. The patient received 5 days of plasma exchange and continued with prednisone. The patient had returned to his baseline prior to influenza shot. Concomitant vaccines and prior exposure to Fluzone were not reported. The patient medical history included initial bout of [[name]] Barre Syndrome which occurred about 23 March 2003. The patient experienced total body paralysis and was on a ventilator for 5 days at another hospital. On about 20 [[name]] 2004 the patient had a relapse with full body paralysis again. Hospital discharge summary and laboratory results are available upon request.					Y	5			Y	11/20/2004	03/23/2004			UNK	UNK	Simvastatin, Lisinopril, Atenolol, Glyburide, Multivitamin, Brewers Yeast		Coronary artery disease, hypertension, diabetes, hyperlipidemia, gastro-intestine disorder, skin carcinoma, kidney calculus, Guillain Barre syndrome.		200603230	1						2	Asthenia; Condition aggravated; Guillain-Barre syndrome; Paralysis; Plasmapheresis	FLU3~SANOFI PASTEUR~U1479AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0263510	11/14/2007	CA	39.0	39		F	01/16/2007	Initial report received on 14 November 2006 from a health care professional.  A 39-year-old female patient, who was taking Prozac, Wellbutrin, Advair, and Tylenol; and who is allergic to aspirin, had received a left deltoid dose of FLUZONE SV '2006-'2007 USP, lot number U2240AA, on 12 September 2006.  The route of administration was not reported.  Immediately following the vaccination, the patient was lightheaded, faint, and had dizziness.  Treatment received was not reported.  That evening post-immunization, the patient began to have right eye visual disturbances, right eye floaters, and had blind visual field in the right eye.  Diagnostics and treatments received were not reported.  Forty-three days later, the patient had a carotid ultrasound that was within normal limits.  Thirteen days later, the patient had a visual field test that was within normal limits.  The patient has not recovered from these adverse events.  Nineteen days prior to the vaccination on 12 September 2006, the patient had a deltoid dose of Vaqta, manufacturer Merck, lot number 01445, on 24 August 2006.  The route of administration was not reported.  A corrective version of this case was created in order to remove the term seriousness criteria: other - medically significant from the patient outcome screen.  This case is considered as non-serious.  No new medical information was obtained.				Y					N	09/12/2006	09/12/2006	0	25 October 2006, A carotid ultrasound was within normal limits; 08 November 2006, Visual field test was within normal limits	PVT	OTH	PROZAC, WELLBUTRIN, TYLENOL, Advair		It is unknown if the patient had any illnesses, but she was taking Prozac, Wellbutrin, Advair and Tylenol at the time of the vaccination on 12 September 2006.  The patient has allergies to aspirin.		200603097	1						2	Dizziness; Immediate post-injection reaction; Ultrasound Doppler; Visual disturbance; Visual field tests abnormal; Visual field tests normal; Vitreous floaters	FLU3~SANOFI PASTEUR~U2240AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0265238	11/14/2007	CA	72.0	72		M	11/01/2006	Initial report received on 16 October 2006 from the patient. A 73-year-old male patient, with a history of cardiomyopathy, osteoporosis, and arthrostatic tremors, had received an intramuscular, left arm injection of Fluzone SV 2006-2007, lot number U2177AA, on 29 September 2006. Three hours post-vaccination, he experienced confusion and felt as though his brain didn't function.  He was also lightheaded, dizzy, and his legs were extremely weak. Per the reporter, now legs are collapsing. The event did not require examination by a physician. At the time of this report, the patient had recovered.									Y	09/29/2006	09/29/2006	0		UNK	UNK	FOSAMAX, SPIRONOLACTONE, DIOVAN, BUSPIRONE, LEVOTHROID, BUPROPION		The patient had a history of arthrostatic tremors, cardiomyopathy, osteoporosis, and an allergy to sulfa.		200602688	1						2	Confusional state; Dizziness; Muscular weakness	FLU3~SANOFI PASTEUR~U2177AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0265331	11/14/2007	MA	34.0	34		F	12/19/2006	Initial report received on 25 October 2006 from a health care professional.  A 34-year-old female patient, with no current illnesses, and allergies to trees, grass, and mold, had received a first dose, right deltoid, intra-muscular injection of FLUZONE SV '2006-'2007 USP, lot number U2213AA, on 20 October 2006 at 14:30 pm.  Approximately five and a half hours post-immunization, at 20:00 pm, the patient developed bilateral conjunctivitis with bright red eyes, burning in both eyes but no discharge or pus.  This lasted less than 24 hours.  She also had a cough, headache, muscle aches, and fever.  She did not take her temperature.  The patient did not seek medical attention, and no diagnostic tests or laboratory data were performed.  At the time of this report, the patient had recovered from these adverse events.  Follow-up information received on 14 December 2006.  The patient did not have any other vaccine within 4 weeks of Fluzone and she did not have any illness at the time of vaccination.  The patient did not seek medical attention, therefore, she was not diagnosed with conjunctivitis.  The symptoms lasted for 24 hours after the vaccine was administered, she recovered on 21 October 2006.									Y	10/20/2006	10/20/2006	0		OTH	PVT	Flonase spray	The patient had no current illnesses.	Is allergic to trees, grass, and mold.  She has had no other vaccinations within four weeks of the vaccination on 20/Oct/2006.  No other medical conditions.		200602809	1						2	Conjunctivitis; Cough; Eye irritation; Headache; Myalgia; Ocular hyperaemia; Pyrexia	FLU3~SANOFI PASTEUR~U2213A~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0265904	11/14/2007	OH	45.0	45		M	02/07/2007	Initial report received on 02/Nov/2006 from the patient. A 45-year-old male patient, with no concurrent illnesses, asthma for 20 plus years, and pneumonia twice in 1993, had received a right deltoid dose of FLUZONE SV 2006-2007 USP, lot number U2217AA, on 23 October 2006. The route of administration was not reported. 48 hours post-immunziation, the patient developed a headache, nasal congestion, sore throat, hoarse voice, fever, and shortness of breath. He was evaluated in an urgent care center three days later, and a chest X-ray showed markings. On 02 November 2006, it was reported that the patient had been experiencing for a couple of days, bloody sputum, severe cough, shortness of breath, and his left eye was very red. He was to have a follow-up visit with his physician on 03 November 2006. At the time of this report, the patient had not recovered. Follow-up information received on 17 November 2006. The patient also had a history of sleep apnea. He went to a pulmonologist for evaluation. His status is unknown. Laboratory results was provided. A lower respiratory culture taken on 03 November 2006, had a result of routine respiratory flora. A CT Chest was done on 03 November 2006 with the following impression: 1. The lungs are well expanded and clear. No emphysematous changes, no bronchiectasis, no pneumonia or pleural effusions are seen. 2. No medistinal or hilar adenopathy. Heart size is normal. 3. Upper abdominal viscera remarkable only in that there are few coarse calcifications in the pancreas, no gallstones are seen. Adrenals and top of kidneys clear. 4. Bilateral gynecomastia noted. Follow-up information received on 20 December 2006 from a health care professional. The vaccine had been administered intramuscularly per the patient. The reporter had not seen the patient in follow-up, but provided a copy of an evaluation by a pulmonary specialist. The patient was examined by a pulmonary specialist seven days post-vaccination for an initial evaluation complaining of cough and wheeze since October with some associated episodes of hemoptysis. The patient had been taking Medrol, Flovent, oral albuterol, Singulair, and Spiriva on an inconsistent basis. The episode of hemoptysis was reported as blood streaking and sputum after severe episodes of cough. There was no frank hemoptysis present. Per the reporter, I am not convinced that the change in his symptoms are related to the vaccine. His first symptoms appeared as a child. They received during adolescence and recurred during his 20's. They have been persistent since 1993. He notes daily symptoms in the morning. The patient had a reflux component that had been recently treated with Aciphex. Physical exam was non-contributory. Impression was dyspnea, wheeze, cough, likely representating asthma (moderate chronic), history of atopy, obstructive sleep apnea syndrome, hemoptysis, and GERD. Pulmonary function testing was to be scheduled. Recovery status was not provided. Follow-up information received on 01 February 2007. There was no additional information. The reporter did not believe the signs and symptoms were due to the vaccine.				Y					U	10/23/2006	10/25/2006	2	28 October 2006: Chest X-ray showed markings Follow-up information received on 17 November 2006. Laboratory results were provided. A lower respiratory culture taken on 03 November 2006, had a result of routine respiratory flora. A CT Chest was done on 03 November 2006 with the following Impression: 1. The lungs are well expanded and clear. No emphysematous changes, no bronchiectasis, no pneumonia or pleural effusions are seen. 2. No medistinal or hilar adenopathy. Heart size is normal. 3. Upper abdominal viscera remarkable only in that there are few coarse calcifications in the pancreas, no gallstones are seen. Adrenals and top of kidneys clear. 4. Bilateral gynecomastia noted.	PUB	UNK	Flovent, Albuterol, Prednisone, Medrol, Singulair, Spiriva		The patient had no concurrent illnesses at the time of the vaccination on 23 October 2006. He has had asthma for 20 plus years, and had pneumonia twice in 1993. The patient has a past history of atopy, obstructive sleep apnea, and hemoptysis. GERD was a relevant ongoing illness		200602940	1						2	Chest X-ray normal; Cough; Culture; Dysphonia; Dyspnoea; Gynaecomastia; Haemoptysis; Headache; Laboratory test; Nasal congestion; Ocular hyperaemia; Pharyngolaryngeal pain; Pyrexia; Wheezing	FLU3~SANOFI PASTEUR~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0266211	11/14/2007	VA	48.0	48		F	12/19/2006	Initial report received from a nurse on 07 November 2006.  A 48 year old, female patient experienced a sore arm, periodic heart palpitations and slight shortness of breath, after she received Fluzone (lot number U2241AA) intramuscularly in the left arm on 06 November 2006.  Approx. 11 years ago, she had the same symptoms with post partum hyperthyroid problem.  It was unknown how many doses of flu vaccines she received in the past.  The vaccine was given at approx. 12 noon with no problems, except a sore arm until approx dinner time then complaints of periodic heart palpitations like (she) just ran a marathon, slight shortness of breath continued off and on through the next day.  The patient had no other symptoms and no treatment.  It was reported the patient recovered.  She was not on any other medications and did not have any illness at the time of vaccination.  Follow-up information received on 15 December 2006.  The reporter stated the episodes lasted for approximately 1 week and the patient has had none since.									Y	11/06/2006	11/06/2006	0		OTH	PVT			Approx. 11 years ago had the same symptoms with post partum hyperthyroid problem.		200602973	1						2	Dyspnoea; Pain in extremity; Palpitations	FLU3~SANOFI PASTEUR~U2241AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0266519	11/14/2007	CA	32.0	32		F	11/16/2006	Initial report received from a health care professional on 13 November 2006.  A 32 year old, female patient experienced arm pain after she received Fluzone (lot number U2240AA) in the left deltoid on 27 October 2006.  The Fluzone leaked at the side of the syringe (BD Integra) where the needle attaches.  The vaccine dripped down the patient's arm and got on her face.  The 0.3 mL (adjusted dose) was then readministered.  As per the reporter, the patient recovered, except for the arm pain.									N	10/27/2006	10/27/2006	0		OTH	PVT					200603071	1						2	Accidental exposure; Device leakage; Incorrect dose administered; Pain in extremity	FLU3~SANOFI PASTEUR~U2240AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0268001	11/14/2007	CO	57.0	57		F	05/04/2007	Initial report received from a nurse on 29 November 2006.  A 57 year old, female patient (with a medial history of exercised induced asthma) experienced cough and tightness in the chest, 4 days after she received in intramuscular injection of Fluzone (lot number U2240AA) in the left deltoid on 20 October 2006.  She was administered 2 puffs of albuterol inhaler and 25 mg PO Benadryl.  She did not have any illness at the time of vaccination.  The symptoms resolved and the patient recovered.  Follow-up information received on 30 April 2007.  The patient experienced the symptoms 3 hours after the received Fluzone.  She self administered the albuterol inhaler and Benadryl PO and had immediate relief.									Y	10/20/2006	10/24/2006	4		PUB	PUB			Exercised induced asthma		200603301	1						2	Chest discomfort; Cough	FLU3~SANOFI PASTEUR~U2240AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0268072	11/14/2007	OR	50.0	50		F	12/11/2006	Initial report received from a pharmacist on 30 November 2006.  A 50 year old, female patient developed swelling in the neck area - gland, tender and swollen to walnut size, 1 hour after she received an intramuscular injection of Fluzone (lot number U2213AA0 in the left arm on 29 November 2006.  The swelling was diminished the next day but was still swollen and tender.  She did not have any known allergies and did not have any illness at the time of vaccination.  At the time of the report, the patient's outcome was not reported.									U	11/29/2006	11/29/2006	0		OTH	PVT	LIPITOR		No known allergies.		200303332	1						2	Lymph node pain; Lymphadenopathy	FLU3~SANOFI PASTEUR~U2213AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0269053	11/14/2007	AK	46.0	46		F	06/07/2007	A non-serious case was received from a consumer on 07 June 2007.  A 48-year-old female patient with a history of Sulfa allergy had received an intramuscular right arm injection of Fluzone 2006-2007 (U2237AA) on an unknown date.  Immediately following the injection, the consumer experienced swelling the size of a softball, and also reported that the area became reddened and firm.  She denied pruritus.  Ice was immediately applied to the area, and the swelling decreased within an hour and resolved completely after a few days.  She denied any other symptoms, and stated that she had received Fluzone in the past.  The consumer also reported this event elsewhere.  Follow-up information received from the vaccine provider on 06 July 2007.  The patient received an intramuscular right deltoid injection of Fluzone on 20 October 2006 at 8:15AM.  She experienced immediate swelling and discoloration at the injection site.  Swelling continued for approximately 40 minutes.  The entire upper arm, from shoulder to elbow, became swollen.  The patient's face and neck flushed bright red and she experienced lightheadedness and a tingling sensation of arm and fingers.  All symptoms resolved within 90 minutes.  The patient had no illness at the time of vaccination.  She had not received any other vaccinations within the four weeks prior to this Fluzone vaccination.  The patient had received two previous doses of Fluzone.  The reporter indicated that no additional information was available at the time of this report.									Y	10/20/2006	10/20/2006	0		OTH	PUB	None	The patient had no illness at the time of vaccination.	Allergy to Sulfa		200702100	1						2	Dizziness; Erythema; Flushing; Immediate post-injection reaction; Induration; Injection site erythema; Injection site induration; Injection site swelling; Oedema peripheral; Paraesthesia	FLU3~SANOFI PASTEUR~U2237A~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0270546	11/14/2007	IL	79.0	79		F	04/20/2007	Initial report received on 07 March 2007 from other manufacturer (under the reference number 1-101246764).  The report was initially reported by a consumer.  A female patient received on 25 October 2006 an unspecified flu shot (manufacturer unknown, lot number not reported) and woke up the next day and had shingles.  She believed the flu shot caused her to get shingles.  No additional information was provided.  Follow-up information received from the patient on 16 April 2007.  The patient (who had a history of diabetes and congestive heart failure) developed shingles the next day, after receiving Fluzone (lot number U2188AA) in the right deltoid and pneumococcal vaccine Merck (lot number 0391F) in the left deltoid on 25 October 2006 at 4:30PM.  She was put on Valtrex, triamcinolone and calamine lotion.  She had bacteria pneumonia - 08 February 2006 and was hospitalized for 8 days.  At the time of the vaccinations, she reported that she had a cold.  She had received an influenza vaccine over 5 years before and received the pneumococcal vaccine in 1995.  In December 2006, she had a virus and was prescribed Robitussin DM for cough and Sudafed.  As of 2 January 2007, she did not have any blisters.				Y					Y	10/25/2006	10/26/2006	1		OTH	OTH		At the time of the vaccinations, she reported that she had a cold.	Follow-up information received on 16 April 2007.  History of diabetes and congestive heart failure.  She had bacterial pneumonia - 08 February 2006 and was hospitalized for 8 days.  She had received an influenza vaccine over 5 years before and received the pneumococcal vaccine in 1995.		200700606	1						2	Herpes zoster; Herpes zoster	FLU3~SANOFI PASTEUR~U2188AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0391F~UNK~~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U2188A~2~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0391F~2~UN~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0270582	11/14/2007	FL	49.0	49		F	01/17/2007	Initial report received on 16 January 2007 from the patient. A 49-year-old female patient, with a history of fibromyalgia, osteoporosis and past reaction to flu vaccine lasting 24 hours (date of vaccination not reported), had received a dose of FLUZONE SV '2006-'2007 USP on 01 December 2006. The lot number, route and site of administration was not reported. Five minutes after receiving the Fluzone vaccine, the patient was in her care and began having knife-like pain in her chest lasting for five minutes. The patient returned to the doctors office where she was treated with Nexium. Further treatments and diagnostic tests performed were not reported. The patient had last received a flu vaccination in 1998. Information regarding that vaccination was not provided. At the time of this report, the patient was still having little tinges of pain in her chest.				Y					N	12/01/2006	12/01/2006	0		UNK	UNK			The patient has a history of fibromyalgia and osteoporosis. She has a past history of reaction to flu vaccine lasted 24 hours (date of vaccination not reported). The patient also last had a flu vaccine in 1998. Information regarding either vaccination was not reported.	No adverse effect~Influenza (Seasonal) (no brand name)~UN~41.00~In Patient	200700127	1						2	Chest pain; Dyspnoea; Chest pain	FLU3~SANOFI PASTEUR~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0286728	11/14/2007	TX	62.0	62		F	10/23/2006	Initial report received on 05 October 2006 from the patient.  A 62-year-old female had received a right deltoid injection of Fluzone SV, lot number not reported; and a right deltoid injection of Pneumovax, manufacturer Merck, lot number not reported; on 04 October 2006. Five to six hours later, she developed fever and waves of pain.  The site of the waves of pain was not specified.  Per the reporter, she still had muscle pains and aches and plans to see a physician.  At the time of this report, recovery status was reported as unknown.									U	10/04/2006	10/04/2006	0		UNK	UNK					200602622	1						2	Chills; Injected limb mobility decreased; Injection site pain; Pain; Pyrexia; Myalgia; Pain; Pyrexia	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~~UNK~UN~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0295132	11/14/2007		48.0	48		F	11/13/2007	Information has been received from a pharmacist concerning a 48 year old female patient with no medical history or allergies who on 30-OCT-2007, was vaccinated IM into the left arm with a first 0.5ml dose of Pneumovax 23 (Lot# 658074/0803U). There was no concomitant therapy. The day of the vaccination, the patient experienced minor swelling and the patient was unable to move her arm due to pain. On 31-OCT-2007, the patient went to the clinic and was treated with sulfamethoxazole (+) trimethoprim (BACTRIM) and acetaminophen (+) propoxyphene napsylate (DARVOCET) for the pain. Subsequently, the patient had fully recovered. No product quality complaint was involved. Severe arm pain, unable to move her arm and minor swelling were considered to be disabling. This is one of 4 reports from the same source. Additional information has been requested.				Y				Y	Y	10/30/2007	10/30/2007	0	Unknown	OTH	OTH	Unknown		Unknown		WAES0711USA00889	1						2	Erythema; Injected limb mobility decreased; Oedema peripheral; Injected limb mobility decreased; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2499AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0803U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~0803U~1~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Disabling	Influenza
0295219	11/14/2007		56.0	56		F	11/13/2007	Information has been received from a pharmacist concerning a 56 year old female patient with no medical history or allergies who on 30-OCT-2007 was vaccinated IM into the left deltoid with a first .5ml dose of Pneumovax 23 (Lot# 658074/0803U). There was no concomitant medication. Approximately 4 hours after the administration, the patient experienced severe arm pain extending from the injection site to the elbow. Approximately 8 hours after the vaccination, the patient developed a 12 inch radius rash that extended down the patient's arm, to her back and chest. The patient also experienced difficulty moving the affected arm which has caused significant disability. On 31-OCT-2007, the patient went to the clinic and received diphenhydramine hydrochloride (BENADRYL) and ibuprofen (MOTRIN) for the events. The next day the patient received hydroxyzine hydrochloride (ATARAX) and methylprednisolone (MEDROL) dose pack. The final diagnosis was reported as allergic reaction. Laboratory diagnostic studies were not performed. At the time of this report, the patient had recovered but her arm had a bruised feeling but no bruise was present. No product quality complaint was involved. The reporter considered the events to be related to Pneumovax 23 vaccine. Severe arm pain, allergic reaction, difficulty moving affected arm and rash were considered to be disabling. This is one of 4 reports from the same source. Additional information is not expected.				Y				Y	Y	10/30/2007	10/30/2007	0	None	OTH	OTH	None		None		WAES0711USA00888	1						2	Injection site pain; Injection site rash; Injection site swelling; Hypersensitivity; Injected limb mobility decreased; Injection site pain; Pain in extremity; Rash	FLU3~SANOFI PASTEUR~U2499AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0803U~2~IM~LA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~0803U~1~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Disabling	Influenza
0296569	11/14/2007	PA	30.0	30		F	11/14/2007	Dizziness, chills, shortness of breath and chest pain, fever of 102 degrees. Benadryl was given as treatment.									Y	11/06/2007	11/06/2007	0		PUB	PVT		N/A	N/A			1						1	Chest pain; Chills; Dizziness; Dyspnoea; Pyrexia	FLU3~SANOFI PASTEUR~U25166AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296622	11/14/2007	TX	0.5	0	.5	M	11/13/2007	Information has been received from a physician concerning a 6 month old male with no pertinent medical history or drug allergies who on 30-OCT-2007 was vaccinated PO with his third 2.0 ml dose of Rotateq. Concomitant vaccinations administered on that same day included a dose of PedvaxHib (manufacturer unknown), a dose of (PREVNAR), a dose of (PEDIARIX) and a dose of influenza virus vaccine (unspecified). On 01-NOV-2007 the patient experienced blood in the stool which was still occurring at the time of the report. The patient was seen by the physician and the following labs and diagnostic studies were performed: Clostridium difficile, rotavirus, salmonella, and shigella and allergy testing for egg, soy and milk. The patient was not recovered. There was no product quality complaint. Upon internal review, blood in the stool was determined to be an other important medical event. Follow-up information has been received from a physician indicating that the patient's lab diagnostic studies performed: Clostridium difficile, salmonella, shigella, rotavirus, egg, soy and milk allergy testing were all negative. The patient was not diagnosed with intussusception. The physician also noted the patient recovered. Additional information has been requested.				Y					Y	10/30/2007	11/01/2007	2	allergy test 11/??/07 - egg-negative; allergy 11/??/07 - soy-negative; allergy test 11/??/07 - milk-negative; stool Clostridium 11/??/07 - negative; stool Shigella culture 11/??/07 - negative; stool Salmonella 11/??/07 - negative; stool culture 11/??/07 - rotavirus-negative	OTH	OTH			None		WAES0711USA01773	1						1	Allergy test negative; Culture stool negative; Haematochezia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~DTAP + HEPB + IPV (PEDIARIX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~UNK~UN~UN~HIB (NO BRAND NAME)~1|PNC~PFIZER\WYETH~~UNK~UN~UN~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0296625	11/14/2007	CO	60.0			M	11/09/2007	Initial report received on 02 November 2007 from a health care professional. A 60-year-old male patient had received an injection of Fluzone SV, lot number unknown, route and site of administration unknown, on 02 November 2007 at 10:00 am. Approximately 90 minutes post-vaccination, the patient was admitted to the hospital with a glucose of 22. The patient had reportedly exercised that morning and not eaten breakfast. He was admitted for 24 hours, his glucose level was stabilized, and he was discharged. The patient had a past history of unknown allergies. He had a family history but no personal history of diabetes. Illness at the time of vaccination and other medications were unknown. Recovery status was not reported.					Y	1			U	11/02/2007	11/02/2007	0		OTH	OTH			The patient had a history of unknown allergies, and a family history of diabetes.		200703737	1						1	Blood glucose decreased	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0296626	11/14/2007	KS	72.0			F	11/09/2007	Initial report received from a patient on 01 November 2007. A 72-year-old female with history of allergies to multiple medications had received a dose of flu vaccine (trade name, manufacturer, lot number, route/site of administration not reported). The symptoms progressed until the patient was hospitalized for two weeks on oxygen and breathing treatments. The patient indicated that they were unable to find the cause, but she also reported being that it was probably due to bronchitis No additional information had been provided at the time of this report. The reporter of this case is the same as for case 2007-03697, which involves increasing difficulty breathing, wheezing and cough experienced by the same patient following receipt of Fluzone SV 2007-2008, lot number unknown.					Y	14			U					UNK	UNK			The patient had a history of allergies to Darvocet, Percocet, codeine, streptomycin and Sporanox.		200703698	1						1	Bronchitis; Cough; Dyspnoea; Oxygen supplementation; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0296627	11/14/2007	KS	72.0	72		F	11/09/2007	Initial report received from a patient on 01 November 2007. A 73-year-old female with history of allergies to multiple medications had received a left deltoid injection of Fluzone SV 2007-2008 (lot number and route of administration unknown) on 17 October 2007. Soon after (exact date not reported), the patient experienced difficulty breathing that worsened over the next two weeks. The patient also had wheezing and a cough. On 28 October 2007, the patient went to the emergency room where results were normal for a chest x-ray, EKG, CT scan and blood work. The patient was discharged from the emergency room and was subsequently seen by her physician who ordered prednisone. At the time of the report, the patient indicated that she was still very short of breath with coughing and wheezing, but also stated that it was improving. The patient reported having the same symptoms last year after receiving a flu vaccine (unknown brand) at the same location. The patient was scheduled to follow-up with her physician on 05 November 2007. The reporter of this case is the same as for case 2007-03698, which involves difficulty breathing, cough and wheezing experienced by the same patient last year following receipt of a flu vaccine (unknown brand).				Y					N	10/17/2007	10/17/2007	0	Normal results for chest x-ray, EKG, CT scan and blood work.	PUB	OTH	DIOVAN; ENALAPRIL; SYNTHROID; VITORIN; DICLOFENAC; NASONEX		The patient was allergic to Darvocet, Percocet, codeine, streptomycin and Sporanox. Concomitant medications were Diovan, enalapril, Synthroid, Vitorin, diclofenac and Nasonex; however, indication were not reported. The patient denied having any illness at the time of vaccination and denied receiving any other vaccines on 17 October 2007. She also denied receiving any other vaccinations within four weeks prior to 17 October 2007. Following a flu vaccination (brand unknown) last year, the patient experienced the same symptoms of difficulty breathing, wheezing and cough, which progressed until she was hospitalized for two weeks on oxygen and breathing treatments. The patient indicated that they were unable to find the cause, but also reported being told that it was probably due to bronchitis.		200703697	1						1	Blood test normal; Chest X-ray normal; Computerised tomogram; Cough; Dyspnoea; Electrocardiogram normal; Vaccine positive rechallenge; Wheezing	FLU3~SANOFI PASTEUR~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296628	11/14/2007	NY				F	11/09/2007	Initial report received on 31 October 2007 from a physician. A female patient (date of birth and age not provided), who denied any concurrent illnesses, and who had past medical history of hypertension and hypercholesterolemia that was being tested with Altace, antihypertensives, and Lipitor, had received a subcutaneous right deltoid dose of FLUZONE SV 2007-2008 (lot number U2491AA) on 18 October 2007. Subcutaneous injections of Fluzone SV 2007-2008 is not a recommended route of administration by the manufacturer. The following day after receiving the vaccination, the patient developed generalized hives, hypotension (blood pressure 90/50, and increased heart rate of 140 beats per minute. The patient did not seek medical attention until the following day (20 October 2007) when she was evaluated by a physician in the office and treated with steroids and then taken to the emergency room. The patient was treated with Benadryl and Epinephrine in the emergency room. A complete blood count was normal. The patient was released the same day on oral steroids. At the time of this report, the patient had recovered.				Y					Y	10/18/2007	10/19/2007	1	20/Oct/2007: A complete blood count was normal.	PVT	OTH	ALTACE; ANTIHYPERTENSIVES; LIPITOR		The patient denied any illnesses at the time of the vaccination on 18 October 2007. She has a past medical history of hypercholesterol being treated with Lipitor, and hypertension being treated with antihypertensives and Altace.		200703695	1						1	Full blood count normal; Heart rate increased; Hypotension; Incorrect route of drug administration; Urticaria	FLU3~SANOFI PASTEUR~U2491AA~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296631	11/14/2007	FL	59.0	59		F	11/14/2007	GIVEN A FLU SHOT ON 10/09/07, FOLLOWED BY REDNESS AND ITCHING AT THE INJECTION SITE, SCRATCHY THROAT AND WHILE IN TRIAGE PATIENT BECAME A LITTLE LIGHTHEADED.				Y					Y	11/09/2007	11/09/2007	0	NONE	PVT	PVT	UNKNOWN	NO	UNKNOWN			1						1	Dizziness; Injection site erythema; Injection site pruritus; Throat irritation	FLU3~SANOFI PASTEUR~U2530AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296633	11/14/2007	KY	62.0	62		F	11/14/2007	Pt had 4 cm red, warm ,raised at injection site rt deltoid site.									Y	11/12/2007	11/13/2007	1		PVT	PVT	diovan,aldactone,premarin,nexium,tricor,ca+d,lipitor,protonix,fish oil,vit e,flonase,zyrtec		htn,hyperlipid,sesonal allergies,			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA055AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1381U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296634	11/14/2007	MA	22.0	22		M	11/14/2007	patient received influenza vaccine at clinic held at his day treatment program on 11/09/07, he had already recieved the influenza vaccine.  Thus he received vaccination twice.									Y	11/09/2007	11/09/2007	0		PUB	PUB	Risperdal, lithium, trileptal, topomax, prilosec and ativan	none known	Paranoid schizophrenia, GERD and seasonal allergies			1						1	Accidental overdose; Inappropriate schedule of drug administration; Medication error	FLU3~SANOFI PASTEUR~U2523AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296637	11/14/2007	TX	8.0	8		F	11/14/2007	Patient complained about stomach cramps 6 hours after she received the flumist dose.  Stomach cramps continued throughout the evening and she developed a temperature of 105 degrees F.  Friday morning, Nov. 9th, her pediatrician instructed them to go to the Emergency Room.  The patient was seen and diagnosis with gastritis from the flumist.  She was placed on a liquid diet.  She still has mild stomach cramps to this day.				Y					Y	11/08/2007	11/08/2007	0	see above Item #7.	UNK	PVT	na	na	na			1						1	Abdominal pain upper; Body temperature increased; Gastritis; Vaccination complication	FLUN3~MEDIMMUNE VACCINES, INC.~500497P~4~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0296639	11/14/2007	MO	36.0	36		F	11/14/2007	Shot was given very high near shoulder, have had pain in muscle from shot site down to elbow, and have noticed a twitch in my left index finger that began approx. 1 week after shot to current.  Called my physician and was told to take ibuprofen for pain.									N	10/26/2007	10/27/2007	1		UNK	PUB	Phentermine and Ibuprofen after shot.	none	none			1						1	Muscle twitching; Myalgia	FLU3~SANOFI PASTEUR~U2494AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296642	11/14/2007	CT	43.0	43		M	11/13/2007	Headache, Photophobia, Neck Stiffness Beginning 3 days after vaccine seizure, 10 days after vaccine 4/7/08-records received for DOS 10/27-11/03/07-DC DX: Questional aseptic menignitis vs encephalitis. New onset of left bundle branch block. Seen in ED after being found unresponsive at home. Feeling unwell, tired and weak, headache and tinnitus. Woke up screaming and found with eyes folled back, not responding. Seizures observed with jerking movements. Status epilepticus in ED, intubated. Wide complex tachycardia. Temperature increase to 102.9.			Y	Y	Y	7			Y	10/02/2007	10/20/2007	18	MRI of brain -; EEG -; Lumbar puncture; Lumbar Mononuclear cell/HPF 4/7/08-records received-BUN 14, creatinine 1. CPK 215 and peaked in 6000, MB of 2 and peak of 15 and troponin negative. CSF crytococcus antigen negative, Lyme negative, PCR and CMV negative. HSV negative. Blood and urine cultures negative. EEG No focal seiruze noted. CT scan unremarkable. MRI brain negative.	OTH	PUB	ALBUTEROL PRN	None	asthma; mild intermittent		CT200719	1						1	Convulsion; Electroencephalogram normal; Headache; Lumbar puncture abnormal; Musculoskeletal stiffness; Nuclear magnetic resonance imaging brain normal; Photophobia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA282DA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Life Threatening,Hospitalisation	Influenza
0296645	11/14/2007	MI	26.0	26		F	11/07/2007	Awoke from nap 3 hours after vaccination with headache, fever, bloodshot eyes, diarrhea x  once, chest tightness, swollen tongue, throat tightness, slurred speech, expressive aphasia. Admitted for TIA workup. All tests normal. Neurology workup inconclusive. Symptoms completely resolved. Fetus unaffected. Fever 99.8F 12/12/07-records received for DOS 11/1-/07-Admitted with mental status changes and episode of slurred speech, headache. Resolved by arrival at hospital.   PE WNL. Denied numbness and weakness. Felt tired that morning. Neuro consult felt speech difficulty due to swollen tongue. C/O throat tightness.					Y	1			Y	11/01/2007	11/01/2007	0	Normal EKG, Blood tests, Echocardiogram, Carotid Dopplers, CT head 12/12/07-records received-Negative head CT.	PVT	PVT	Generic Prenatal Vitamins	None 12/12/07-records received-38 weeks pregnant.	No allergies; Current 38 week pregnancy records received 12/12/07-38 weeks pregnant.			1						1	Aphasia; Blood test; Chest discomfort; Diarrhoea; Dysarthria; Echocardiogram; Electrocardiogram normal; Headache; Ocular hyperaemia; Pyrexia; Scan brain; Swollen tongue; Throat tightness; Ultrasound Doppler	FLU3~SANOFI PASTEUR~U2451AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0296646	11/14/2007	CA	69.0	69		M	11/13/2007	Patient requested and received a flu & zostavax R vaccines on 10/29/2007.  On 11/12/2007 he went to his primary care physician for painless rashes that have started on 11/9/2007.									U	10/29/2007	11/09/2007	11	Please call Dr. for info about tx.	UNK	UNK		None	None that he has reported to us.  Please confirm with MD.	None~ ()~~0.00~In Patient		1						1	Rash	FLU3~SANOFI PASTEUR~U2523AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~0461U~UNK~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0296647	11/14/2007	TX	14.0	14		F	11/14/2007	After vaccines pt c/o feeling dizzy & blurry vision.									Y	11/14/2007	11/14/2007	0	BP 11/62; none	PVT	PUB	none	healthy girl	none			1						1	Blood pressure; Dizziness; Vision blurred	FLU3~SANOFI PASTEUR~U2437AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2379BA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0296648	11/14/2007	MO	2.0	2	.0	M	11/14/2007	Right thigh red and swollen.									Y	11/12/2007	11/14/2007	2		PVT	PVT	None	No illness	None			1						1	Injection site erythema; Injection site swelling	DTAP~SANOFI PASTEUR~C2760AA~4~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2449AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB182AA~1~IM~LL~HEP A (HAVRIX)~1|HIBV~SANOFI PASTEUR~UF206AA~4~IM~RL~HIB (ACTHIB)~1	USA		Influenza
0296649	11/14/2007	WI	41.0	41		F	11/12/2007	Rcied FluMist about 11am 11/2.  At 4am on 11/3 2 sudden onset rigors & fever, muscle aches/fatigue & extreme high fevers 103+ in spite of Advil.  Tamiflu began about 3pm & symptoms reduced by about 1/2.  Rash also developed in morning on 11/3 (macular & transient).  Rash spread on 11/5 on extremities, myalgias, increased Medrol Dose Pak & Claritin began. Symptoms slowly improved over next couple days.				Y					Y	11/02/2007	11/03/2007	1	None	OTH	PVT		none				1						1	Chills; Fatigue; Myalgia; Pyrexia; Rash macular	FLUN3~MEDIMMUNE VACCINES, INC.~500488P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0296650	11/14/2007	TX	13.0	13		F	11/13/2007	Per parent reaction to shot on back of right arm-red streak, swollen, whole arm sore.  Improved since Saturday 11/10/07.									Y	11/08/2007	11/10/2007	2	None	OTH	OTH	Duac gel	None	None			1						1	Injection site erythema; Injection site pain; Injection site streaking; Injection site swelling; Pain in extremity	FLUN3~MEDIMMUNE VACCINES, INC.~500489P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~1060U~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2331AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~1256U~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0296651	11/14/2007	PA	74.0	74		F	11/14/2007	I wish to report a reaction to the flu shot administered around 2:00 p.m. on October 29--something much worse than just feeling like I have caught a cold.  I was at Bell Choir practice (7:00-8:00 p.m. on Monday) and my throat became excruciatingly sore--like a burning furnace.  A cough drop was of no help at all; however by the next morning my throat felt back to normal.  I tried to talk to my daughter and granddaughter on the way home and couldn't get more than two words out and then gagging.  This continued all the way home--some 15-20 miles.  I didn't try talking and the problem disappeared by the next morning.  My mouth became exceedingly dry and my lips swelled.  The inside of my lower lip still feels spongy and the gums continue to hurt when I brush my teeth--especially the lower teeth.  This has not disappeared.  (I had a thorough dental exam and teeth cleaning on October 4 and there were no problems then).									Y	10/29/2007	10/29/2007	0		PVT	PVT	Imodium, Lisinoprel, Viactiv, vit. D, Evista, Tums, aspirin EC		Allergies: latex, wool, Prednisone.  Medical conditions: irritable bowel symptoms, osteoporosis, hypertension, history-malignant neoplasm gastrointestinal tract.			1						1	Dry mouth; Gingival pain; Irritable bowel syndrome; Lip swelling; Pharyngolaryngeal pain; Retching; Throat irritation	FLU3~SANOFI PASTEUR~U2505AA~5~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296652	11/14/2007	IA	66.0	66		F	11/13/2007	Received both vaccines in right deltoid (unable to use left deltoid due to lymphedema) on Monday, 11/5/07.  Evening of 11/5 had chills and fever.  Tuesday, 11/6 noted redness on arm approximately 3x5 and edema.  Had pain and unable to use arm.  Saw doctor on 11/7 and gave Prednisone Taper.  Arm continued to improve with redness, edema and pain.  Has returned to normal activity.				Y					Y	11/05/2007	11/05/2007	0	None	PUB	OTH	Prednisone	None	Lymphedema left arm, cancer, lots of allergies, mastectomy, sinus			1						1	Chills; Erythema; Oedema peripheral; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2493AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1DOSF~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0296653	11/14/2007	MN	67.0	67		F	11/12/2007	11-8-07 - Shot given at 250 pm; finished work - home by 515 pm, Horse voice, chest tight, mucus, Eyes Red, musucsey, cold, chills, runny nose, Sinus congest slept on n off. Went to work; came home after one hr - Slept - Eyes red - better by 630 ish pm.									Y	11/08/2007	11/08/2007	0		PVT	PVT						1						1	Chest discomfort; Chills; Dysphonia; Nasopharyngitis; Ocular hyperaemia; Rhinorrhoea; Sinus congestion; Sleep disorder	FLU3~SANOFI PASTEUR~U2493AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296654	11/14/2007	GA	35.0	35		F	10/24/2007	Pt seen by PMD 10/9/07.  Dx with sinusitis & pharyngitis, flu like symptoms.  Then present to ER x3 on consecutive days 10/15/07, 10/16/07 & 10/17/07.  Pt was told she had Guillain Barre syndrome, never hospitalized.  Pt reported unable to walk, talk.  Then resolved by 11/17/07 but L sided weakness recurred.  11/16/07 Hospital ER records reviewed which reveal patient experienced intermittently a line showing up on left side of face from left eye to left corner of mouth.  Neuro & psych consults done at outlying hospital & was d/c.  Neuro consult repeated & was found to be WNL.  Recommended observation admit & formal psych evaluation but refused.  D/C to home & outpatient psychiatric f/u. FINAL ER Diagnosis: Bipolar disordr; & conversion reaction. 1/15/08 Reviewed ER medical records which reveal patient experienced 4 days of progressive weakness, body aches, tingling, numbness, difficulty moving extremities, sudden loss of speech when seen 10/15/07 after transfer from outlying ER.  Neuro consult done & found reflexes intact, speech intact & able to move all extremities.  Observed & d/c to home. FINAL DX: weakness. Returned to ER 10/16/07 w/confusion, left arm numbness, unable to walk.  Exam revealed DTRs intact & would speak only to husband.  Attempted to obtain psych consult but patient angry & left. FINAL DX: psychogenic dx.				Y					Y	10/04/2007	10/09/2007	5	LABS: Blood work WNL.  Head CT WNL.	PUB	PVT		none	Bipolar disorder PMH: bipolar disorder, refuses meds.			1						1	Abasia; Aphasia; Hemiparesis; Influenza like illness; Pharyngitis; Sinusitis	FLU3~SANOFI PASTEUR~U2491AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296656	11/14/2007	MA	61.0	61		F	11/14/2007	Patient went to e.d. at night 11/7/07 with fever and upper right arm swelling.  Told to take Benedryl and follow up in clinic in a.m.  Patient came to clinic 11/8/07, arm warm to touch from elbow to shoulder right arm.  Told to continue benedryl and if no improvement, return to clinic or go to e.d.									Y	11/07/2007	11/07/2007	0		PUB	OTH	Advair, Albuterol, Lisinopril, HCTR, Simvastatin, Felodipine, Metformin	None	None			1						1	Oedema peripheral; Pyrexia; Skin warm	FLU3~SANOFI PASTEUR~U2446AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0697U~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296660	11/14/2007	NJ	81.0	81		F	11/14/2007	Arm felt itchy, hot, looked red.  All symptoms close to elbow, not at injection site.									Y	10/30/2007	10/30/2007	0		PUB	UNK	Methotrexate 5ml 1 time week	None	None			1						1	Erythema; Feeling hot; Pruritus	FLU3~SANOFI PASTEUR~U2440AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296665	11/14/2007	MO	28.0	28		F	11/14/2007	Itching, redness.  Given Epinephrine 0.3 mg subq				Y					Y	11/09/2007	11/09/2007	0		UNK	UNK						1						1	Erythema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0296667	11/14/2007	NY	2.0	2	.1	M	11/08/2007	Patient given flu vaccine 10/29/07 - awoke 10/30/07 with hives encompassing torso and face.  Mother to child to urgent care and was treated with benadryl and prednisone.				Y					Y	10/29/2007	10/30/2007	1	Patient had previously no allergies, but lab test to be done to check for egg allergy now.	PVT	PVT	Pulmcort/Albuterol via Neb  Singular/Zyrtec	Well child visit	environmental allergies			1						1	Allergy test; Urticaria	FLU3~SANOFI PASTEUR~U2458AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296668	11/14/2007	HI	49.0	49		F	10/31/2007	Bilateral rash, both arms x 12 days.									Y	10/10/2007	10/14/2007	4		PVT	PVT			Chronic itch (source unknown), undergoing radiation therapy (breast cancer).			1						1	Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA026AA~7+~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0296669	11/14/2007	MD	45.0	45		F	10/19/2007	ON MY WAY HOME FELT TIGHTNESS IN ARM AND NECK. PAIN IN RIGHT ARM LEADING TO RIGHT SIDE OF NECK - FELT LIKE PULLED MUSCLE. TOOK BENADRYL AND TYLENOL - WOKE UP WITH CHILLS THEN SWEAT - SLEPT 12 HOURS. (SOME ACHES TODAY - NECK AND ARM SORE)									U	10/18/2007	10/18/2007	0		OTH	OTH		None	None			1						1	Chills; Hyperhidrosis; Hypersomnia; Limb discomfort; Muscle tightness; Musculoskeletal discomfort; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLAD38AA~6~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0296670	11/14/2007	LA	35.0	35		F		Full body rash, itching within 20 minutes of Fluarix flu prefilled vaccine. Airway patent. No known latex or egg allergy.									Y	11/07/2007	11/07/2007	0	N/A	OTH	OTH	None	None	None			1						1	Pruritus generalised; Rash generalised	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA317AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296671	11/14/2007	MA	48.0	48		F	11/07/2007	11/1/07 Flu vaccine, states eye drainage x 2 days; HA x 3 days, body aches.									Y	11/01/2007	11/02/2007	1		OTH	PVT	B12	None	None			1						1	Eye discharge; Headache; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA30303AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296672	11/14/2007	MA				F	11/07/2007	Felt achy several hours after vaccine.  In a.m., 102 temperature, took motrin 2x, H/A during daytime.  Friday a.m., felt fine.  States similar episode when she received injection last time (2 years ago).									Y	10/31/2007	10/31/2007	0		MIL	PVT	Tylenol, Codeine	None	Allergy - Aleve			1						1	Body temperature increased; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA303AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296673	11/14/2007	NY	6.0	6		M	11/02/2007	Pt received Influenza vaccine; became diaphoretic and tachycardic about 15 min after received vaccine - Pt recovered in supine position on exam table. EMS responded transported to medical center.				Y					Y	11/02/2007	11/02/2007	0	None	OTH	PUB	None today - hx of asthma, Rx with albuterol neb prn	Well child	Allergic to corned beef - asthma - status encephalopathy			1						1	Hyperhidrosis; Tachycardia	FLU3~SANOFI PASTEUR~U2437AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296674	11/14/2007	OH	56.0	56		F	11/05/2007	Patient had numbness/tingling shortly after (in arm) that resolved same day. Patient developed rash at margin of bandage which eventually looked like cut that was not healing. She saw doctor on 10/18 and was prescribed Bactrim DS. she did not complete 7 day course because of insomnia. The wound did scab over and was healing as of 10/25/2007.				Y					Y	10/09/2007				OTH	PVT	Vagitem		Fluconazole allergy			1						1	Hypoaesthesia; Insomnia; Paraesthesia; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA298AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296677	11/14/2007	WY	42.0	42		F	11/09/2007	Pain, hot to touch, swelling on R deltoid and up to neck.  Ill feeling.  Seen by FNP.  Placed on Prednisone.				Y					Y	10/24/2007	10/24/2007	0		PUB	PUB	none	no	none			1						1	Local swelling; Malaise; Neck pain; Oedema peripheral; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~U2463AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296690	11/14/2007	TX	53.0	53		F	10/27/2007	oct.28.2007 treated for upper respritory viral infected.sept.10 2007recieved influensa vaccine.sept.17 2007treated for viral infection complecated by influensa vaccine.oct.27 2007died heart failer complecated by virial infection  11/16/07 Reviewed vaccine record from pcp & VAERS database updated w/same.   11/27/07 ER Final dx: cardiac arrest, expired. Reviewed hospital medical records which reveal patient experienced chest & left arm pain, cold & clammy, skin mottled, nauseated, felt faint & passed out when EMS arrived.  EMS rhythm strip revealed BBB w/ST segment depression.  In ER, vomited & had diarrhea.  EKG revealed atrial fib w/rapid ventricular response.  DX w/acute bronchitis & atrial fib w/RVR.  Became unresponsive & developed cardiac arrest.  Resuscitated & intubated.  While being tansferred to higher level of care via helicopter, coded again.  Returned to ER & unable to resuscitate.  3/7/2008 Judge states he signed death certificate as directed by state law when patient is not in hospital & only seen in ER but paper copy no longer available. States COD as undetermined & manner of death natural.  3/11 Death certificate reviewed & states COD as undetermined & manner of death as natural.	Y	10/27/2007							N	10/10/2007	10/15/2007	5	LABS: WBC 18.3 (H), segs 81%(H), monos 3% (L), lymphs 16% (L), platelets 482 (H).  CK 24, CKMB 17.8, troponin neg.  AST 37, LDH 234.  PT/PTT 17.6/26l6, INR 2.0.  Dig level 1.0.  Blood glucose 451(H),  K 5.4 (H), BUN 28 (H), creat 1.3, Cl 93 (L), CO2 16.7 (L), NA 130 (L).  CXR revealed cardiomegaly, mild failure w/minimal bilateral perihilar infiltrates.  Repeat CXR revealed increased failure w/diffuse pulmonary edema & bilateral infiltrates suggesting aspiration pneumonia.	PVT	OTH		UPPER RESPRITORY VIRAL INFECTION	PMH: mitral valve replacement 1996 w/recent coumadin change, rheumatic fever, CVA x 2-3, HTN, Type 2 DM, CHF, mitral valve stenosis allergy to phenobarbital.			1						1	Cardiac failure; Death; Vaccination complication; Viral infection	FLU3~PFIZER\WYETH~AFLLA037AA~UNK~~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Results in Death	Influenza
0296692	11/14/2007	MO	43.0	43		F	11/14/2007	I started with chills the night of 11/05.  By the time I went to bed, I was nauseated and achy.  I was chilling so badly that I couldn't stop shaking.  My arm where the injections were given was sore down to my elbow and sore under my arm.  It was so sore that between my other symptoms I was unable to sleep that night.  The next morning the symptoms continued and my fever broke.  My skin had red bloches all over.  I continued to take Ibuprofen and got enough relief to go to work the next day.  The same symptoms contined until 11/7.  My arm was no longer tender after 11/8.									Y	11/05/2007	11/05/2007	0		UNK	PVT	Estrogen	None	None			1						1	Axillary pain; Chills; Injection site pain; Nausea; Pain; Pain in extremity; Rash macular; Sleep disorder; Tremor	FLU3~SANOFI PASTEUR~02488AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0963U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296693	11/14/2007	CA	59.0	59		F	11/14/2007	This is my first Flu vaccine which was administered at 10:15am on Monday, Nov 5th.  Within an hour I started experiencing a moderately severe headache and spent two days in bed with fever and chills.  Note:  I am extremely sensitive to medication.									Y	11/05/2007	11/05/2007	0		UNK	UNK		none	pencilin & aspirin			1						1	Chills; Drug hypersensitivity; Headache; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296694	11/14/2007	TX	43.0	45		M	11/14/2007	0800 11/06/07 Shortly after receiving flu vaccination in left deltoid. Pt described swelling in left hand unable to make a fist. No nausea, dizzness, difficulty breathing, tightness in chest or throat. Only Sx experienced was swelling in left hand. Pt. states went to personal physician who told him it was a reaction to the flu shot and gave him an anti-inflammatory medication, P.O.. Pt. states swelling subsided by approx 2330 on the  6th and has had no other effect from the flu shot. States that he is back to normal again.				Y					Y	11/06/2007	11/06/2007	0	no diagnostic testing performed	UNK	PVT	none	none	nka			1						1	Oedema peripheral; Vaccination complication	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA031AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0296695	11/14/2007	TX	78.0	78		F	11/14/2007	Patient developed Fever 101 or above neck pain and vomiting on the day after recieving the vaccine. Patients daughter called to report symptoms she was advised to toake the patient to the ER for emergent evaluation of symptoms. The patients was taken for evaluation several days later to Dr. I donot have any of the information as far as test or treament which was rendered. Patient was seen by a neurologist and found to have encephalitis thought to be a result of the flu immunization				Y					U	10/22/2007	10/23/2007	1	I do not have any of this information	UNK	UNK	Vasotec,Dyazide	Patient had very mild otitis externa had no fever.				1						1	Encephalitis; Neck pain; Pyrexia; Vaccination complication; Vomiting	FLU3~SANOFI PASTEUR~U2442AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296701	11/14/2007	PA	17.0	17		F	11/14/2007	Pt presented to office on 11/5/07 following the 10/26/07 administration of flumist.  Pt presented with a swollen face and neck, as well as swelling in one limb.  Pt seen for second follow up on 11/9/07.  At this time was determined to possibly have a flumist reaction.  Pt's sx improving.				Y					Y	10/26/2007	11/05/2007	10	CBC, Chem 7, xray	PVT	PVT	Unknown	None	None	None~ ()~NULL~~In Patient		1						1	Full blood count; Laboratory test; Local swelling; Oedema peripheral; Swelling face; Vaccination complication; X-ray	FLUN3~MEDIMMUNE VACCINES, INC.~500488p~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0296702	11/14/2007	TX	29.0	29		F	11/14/2007	Rec.'d shot at 11:40 a.m. Noticed adverse event at 1:00 p.m. c/o burning and itching of the face. Stated that she felt her face swelling. 3:00 p.m. Reported to the school nurse. c/o itching and facial burning. Minimum amount of redness noted. temp - 98.4 / pulse -72 & regular. No difficulty breathing. 4:05 p.m. To ER with a family member.				Y						11/14/2007	11/14/2007	0		UNK	UNK	none	none	allergic to penicillin and codiene			1						1	Burning sensation; Erythema; Pruritus; Swelling face	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA029AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296703	11/14/2007	TN		65		F	11/14/2007	Phlebitis (warm,red,tender) appromiately 10x10 inches in upper right deltoid extending around back of arm. Observed 48 hours after vaccine, symptoms still present. Patient consulted family physician and placed on antibiotics and to follow-up in 5-7 days.				Y					U	11/12/2007	11/13/2007	1		UNK	UNK						1						1	Erythema; Phlebitis; Skin warm; Tenderness	FLU3~SANOFI PASTEUR~U2487AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0958F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0296704	11/14/2007	WA	15.0	15		M	11/14/2007	vaccination was given in the evening. the following AM she had a rash on face and over torso									Y	11/13/2007	11/14/2007	1		UNK	PUB	trileptal, seroquel	none	diabetes			1						1	Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80956~UNK~IM~GM~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0296706	11/14/2007	CA	51.0	51		F	11/14/2007	3 to 4 days after vaccine administration, left arm became sore with a nickel-sized knot.  After three weeks, knot is still there and the area is sore.  Did not feel feverish or tired.  Patient put ice on area yesterday.  This is not the first flu vaccine that the client received. She denies being allergic to eggs.									U	10/30/2007	11/02/2007	3		PUB	PUB	Levothyroxine	no illnesses	none			1						1	Nodule on extremity; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~79489~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296707	11/14/2007	TX	75.0	75		F	11/14/2007	PATIENT EXPERIENCED SWELLING AT INJECTION SITE, NO PAIN OR ITCHING OR REDNESS.  PATIENT WAS ASKED TO BE OBSERVED FOR 40 MINUTES AND THE SWELLING DECREASED SLIGHTLY.  PATIENT WAS CONTACTED 2 HOURS LATER, THE SWELLING HAD SUBSIDED SLIGHTLY MORE.  PATIENT WAS ADVISED TO USE COOL COMPRESSES AT THE INJECTION SITE AND TO TAKE BENADRYL AND OR TYLENOL.  PATIENT'S PRIMARY CARE PHYSICIAN  (MEDICAL NURSE) WAS INFORMED OF THE REACTION.  THE DR. WAS FAXED THE COPY OF THE VACCINE ADMINISTRATION CONSENT FORM.									Y	11/14/2007	11/14/2007	0	NONE	UNK	UNK		NONE	NONE			1						1	Cold compress therapy; Injection site swelling	FLU3~SANOFI PASTEUR~U2499AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0989U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296710	11/14/2007	ID	1.5	1	.5	F	11/14/2007	pt unable to walk 24 hours after vaccine, attempted to stand and could not bear weight, after, 36 hours after vaccine was administerd pt able to walk									Y	11/13/2007	11/14/2007	1		PVT	PVT		diarrhea for 2 weeks				1						1	Abasia	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B049AA~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2459MA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0526U~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B47442D~4~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0299079	11/14/2007	CA	19.0			F	11/14/2007	Information has been received from a registered nurse concerning a 19 year old female with penicillin allergy and ZITHROMAX allergy who on 01-OCT-2007 was vaccinated IM with a 0.5 ml dose of Gardasil (lot# 657006/0188U).  Concomitant therapy given the same day in a different site included a dose of influenza virus vaccine (unspecified). CLARINEX and benzoyl peroxide.  On 04-OCT-2007, the patient experienced shortness of breath, generalized itching and facial redness.  The nurse believed that the patient went to the emergency room but no other details were provided.  At the time of this repot, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.				Y					U	10/01/2007	10/04/2007	3	Unknown	OTH	OTH	benzoyl peroxide; CLARINEX	Penicillin allergy; Drug hypersensitivity			WAES0710USA01470	1						2	Dysphagia; Erythema; Hypersensitivity; Local swelling; Skin tightness; Skin warm; Swelling; Throat irritation; Throat tightness; Urticaria; Dyspnoea; Erythema; Pruritus generalised	FLUX~UNKNOWN MANUFACTURER~unknown~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~unknown~2~IM~RA~HPV (GARDASIL)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HPV4~MERCK & CO. INC.~0188U~UNK~IM~UN~HPV (GARDASIL)~2	USA	Emergency room visit	Influenza
0299434	11/14/2007	PA	3.0	3		M	11/22/2006	Initial report received on 23 October 2006 from a health care professional. A three-year-old male patient, with no past medical history, had received a fourth dose, intramuscular, right thigh injection of Fluzone No Preservative 2006-2007, lot number U2166KA, on 21 October 2006. Six hours later, the patient developed large hive like patches between his neck and knees and throughout his trunk area. The welts were also on his arms. The welts were large, raised, itchy bumps occurring in patches (patches were four to eight inches in diameter). His eating was slightly decreased. The parents spoke with the pediatrician on the phone. The event did not require examination by the physician. The patient was treated with Claritin, Benadryl, and an oatmeal bath. The patient recovered from the event. Follow-up received on 21 November 2006 from a health care professional. The patient had no illness at the time of vaccination. As per the reporter, there was no diagnosis for the event, as the patient was not seen by a physician. Further information is not anticipated.									Y	10/21/2006	10/21/2006	0		OTH	OTH					200602757	1						1	Decreased appetite; Petechiae; Rash pruritic; Urticaria	FLU3~SANOFI PASTEUR~U2166K~4~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299435	11/14/2007	CO	2.0	2	.4	M	01/12/2007	Initial report received on 28 November 2006, from a health care professional.  A 2.5 year old male patient received on 20 November 2006 Fluzone (lot number 02191BA), intramuscular into the left thigh.  On 20 November 2006, within 2 hours of receiving Fluzone, the patient's right eye began to deviate, so as appear cross-eyed.  The problem occurred intermediately for 24 hours.  The patient was seen on 28 November 2006; the patient's mother reported that he continued to have occasional right eye deviation cross-eyed.  No other signs and symptoms reported.  Gait stable, neuro exam (performed).  Not seen by ophthalmologist.  No treatment prescribed.  At the time of this report (28 November 2006), the patient had not recovered.  The patient did not receive Fluzone previously.  A corrective version was created with the same latest received date as the previous version (28 November 2006) for the sole purpose of amending the vaccine given on 20 November 2006 from FLUZONE SV '2006-'2007 USP to FLUZONE No Preservative '2006-'2007.  No new medical information was provided.									N	11/20/2006				OTH	UNK	None	None	Unknown		200603267	1						1	Strabismus	FLU3~SANOFI PASTEUR~U2191B~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299436	11/14/2007	AZ	46.0	46		F	01/24/2007	Initial report received from a nurse on 07 December 2006. A 66 year old, female patient experienced a sore arm, nodule at the injection site and began flu-like signs and symptoms (non-specific) on the evening after she received an injection of Fluzone (lot number U2165DA, route not reported) in the left deltoid on 09 October 2006. She had 1 previous dose of Fluzone in the past and she did not have any illness at the time of vaccination. At the time of the report, she had pain and nodule at the injection site was still persisting; she was unable to sleep on her left arm. She was not recovered. Follow-up information received on 22 January 2007 from a health care professional. The patient was 46-years-old (not 66 as documented in the above narrative). Fluzone No Preservative 2006-2007 had been administered intramuscularly in the left deltoid. The patient had experienced pain at the injection site and entire arm which is worse in the morning and at the end of the day. The patient never had a nodule at the site or flu-like symptoms. She had physical therapy four times since this report and has experienced a little relief with iontophoresis and Advil. At the time of this report. the patient continued to have intermittent pain.				Y					N	10/09/2006	10/09/2006	0		PVT	UNK					200603438	1						1	Injection site pain; Pain in extremity; Sleep disorder	FLU3~SANOFI PASTEUR~U2165DA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299437	11/14/2007	GA	0.9	0	.9	F	12/18/2006	Initial report received from a nurse on 08 December 2006.  A 10 month old, female patient (with a medical history of asthma) developed a generalized, red, flat rash within 3 hours after she received Fluzone (lot number U2200KA) intramuscularly in her left thigh on 30 November 2006.  She did not have any illness at the time of vaccination.  The rash lasted for 3 days and Benadryl was given.  The patient recovered.									Y	11/30/2006	11/30/2006	0		UNK	UNK			asthma		200603447	1						1	Rash erythematous; Rash generalised	FLU3~SANOFI PASTEUR~U2200K~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299438	11/14/2007	AZ	1.0	1	.0	M	04/03/2007	Initial report received from a physician on 21 December 2006.  A 1 year old, male patient (with no medical history) was difficult to console, had difficulty getting to sleep, had increasing tantrums and irritability, in the evening after he received his second dose of Fluzone (lot number UT2191KA) intramuscularly in the left thigh in the morning on 18 December 2006.  He received his first dose of Fluzone (lot number U2220BB) intramuscularly in the left thigh on 18 November 2006.  On 08 December 2006, he received Hep A (Merck, lot number 1209F) intramuscularly in the right thigh and ProQuad (Merck, lot number 0970F) intramuscularly in the right arm.  He was not on any medications and did not have any illness at the time of vaccination.  At the time of the report, the patient had not recovered.  Follow-up information received on 02 April 2007 from a health care professional.  No treatment was provided or needed.  The duration of the events was four to five days.  The patient recovered from the event.									Y	12/18/2006	12/18/2006	0		UNK	UNK					200603616	1						1	Aggression; Emotional distress; Insomnia; Irritability	FLU3~SANOFI PASTEUR~UT2191K~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299439	11/14/2007	TX	63.0	63		F	10/26/2006	Initial information received on 20 October 2006 from the patient.  A 63-year-old female patient, with a history of allergies and hypertension, had received a left deltoid injection of Fluzone SV, lot number unknown, on 06 October 2006.  The reporter believes that she had also received an injection of Pneumovax, manufacturer Merck, lot number unknown, on 06 October 2006.  Immediately post-vaccination, the patient felt warm and itchy all over.  Three days later, she began self treating with Benadryl.  Seven days post-vaccination, the patient experienced shortness of breath, and redness in her skin all over.  She was examined in an emergency room and treated with epinephrine.  She is currently taking a methylprednisolone dose pack.  The patient continues to experience itchiness and redness. On 19 October 2006, the patient was examined by an allergist.  Findings of that visit were not provided.  At the time of this report, the patient had not recovered.				Y					N	10/06/2006	10/06/2006	0		UNK	UNK	Claritin, Singulair, Zantac, Toprol, Diovan, Clonidine		The patient had a history of allergies to pet hair, pollen, and airborne substances. She also had a history of hypertension. The patient had a biopsy of a mole using a local anesthetic three days prior to vaccination.		200602742	1						1	Dyspnoea; Erythema; Feeling hot; Immediate post-injection reaction; Pruritus generalised	FLU3~SANOFI PASTEUR~~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0299440	11/14/2007	NY	5.0	5		M	02/01/2007	Initial report received from a health care professional on 10 January 2007.  A 5 year old, male patient (with a history of local induration with other vaccines and no known allergies) developed swelling, erythema, induration and pruritus extending from the top of the shoulder to the mid arm anteriorly to the lateral edge of the scapula, within one day of receiving Fluzone (lot number U2169NA) intramuscularly in the left deltoid on 09 November 2006.  It extended posteriorly involving the bicep and tricep area.  It was further described as being circumferential.  He denied any systemic symptoms.  There were no other vaccines administered at that time or within 4 weeks.  He had no medical conditions and did not have any illness at the time of vaccination.  The reaction was reported to be completely resolved by 13 November 2006.  Follow-up information received on 26 January 2007.  There was no treatment therapy.  The parents are physicians and reported to the reporter on 10 January 2007 that the area was just observed and since there was no systemic reaction, they were not concerned.  This child, as the mother reported, had had localized reaction to other vaccines.  There were no labs/no diagnostics performed.									Y	11/09/2006	11/10/2006	1		PVT	PVT			Local induration with other vaccines.  No known allergies.		200700084	1						1	Erythema; Induration; Oedema peripheral; Pruritus	FLU3~SANOFI PASTEUR~U2169N~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299449	11/14/2007	PA	56.0	56		F	11/15/2006	A 56 year old female patient received on 26 October 2006, the yearly vaccination of Fluzone (lot number unknown), into the left deltoid. Within 24 hours on 27 October 2006, before noon, the patient was feeling flush/feverish on her face with no other signs and symptoms. No corrective treatment was reported. At the time of the repot (27 October 2006) the patient had not recovered. The patient did not received concomitant vaccinations and the patient did not have any illness at the time of vaccination. The patient's medical history was not reported. No information about prior exposure to Fluzone was provided.									N	10/26/2006	10/27/2006	1		OTH	OTH			No illness at the time of vaccination. No concomitant vaccinations.		200602853	1						1	Flushing	FLU3~SANOFI PASTEUR~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299450	11/14/2007	DC	64.0	64		F	11/16/2006	Initial report received from a patient on 08 November 2006.  A 64 year old, female patient experienced persistent sinus congestion, infection, phlegm and mucous that began on the same day, after she received Fluzone (lot number unknown, route of administration not reported) in the left deltoid on 07 October 2006.  At the time of the vaccination, she had a post nasal drip; she was on medications but they were unknown.  At the time of the report, the signs and symptoms were continuing.  Augmentin was prescribed, but it did not help.				Y					N	10/07/2006	10/07/2006	0		UNK	UNK	She was on medications but they were not known.	At the time of the vaccination, she had a post nasal drip.	Allergies-sulfa, sulfates, and sulfites		200602995	1						1	Increased upper airway secretion; Infection; Sinus congestion	FLU3~SANOFI PASTEUR~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299451	11/14/2007	NJ	30.0	30		F	11/21/2006	Initial report received on 16 November 2006, from a consumer, the patient. A 30 year old female patient received on 13 November 2006, in the afternoon, Fluzone (lot number unknown) (unknown site, dose and route of administration). She had a sore throat that morning (13 November 2006), prior to vaccination. She continued to experience the sore throat after the vaccination. She also experienced after vaccination, cough, sneezing, sinus congestion and headache. At the time of the report, 16 November 2006, the signs and symptoms were still persisting and the patient had not recovered. No corrective treatment was reported. The patient did not receive any concomitant vaccines or medications. No information on prior exposure was reported.									N	11/13/2006	11/14/2006	1		UNK	UNK		Had sore throat prior to vaccination, in the morning of 13 November 2006.			200603160	1						1	Cough; Headache; Pharyngolaryngeal pain; Sinus congestion; Sneezing	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299452	11/14/2007	NJ	32.0	32		F	12/14/2006	Initial report received from a patient on 06 December 2006.  A 32 year old, female patient (with a medical history of seasonal allergies and allergies to antibiotics, but no egg allergy) developed hives around eyes and legs, slight tightness with breathing and her skin on her face felt like burning, on the evening after receiving an injection of Fluzone (lot number unknown, site of administration not reported) in the right deltoid on 18 November 2006.  She did not have any illness at the time of vaccination.  4-5 days post dose, she had right axillary lymphadenopathy.  Her signs and symptoms resolved in 5 days and the patient recovered.				Y					Y	11/18/2006	11/18/2006	0		PVT	UNK	Allegra D, birth control pills	She did not have any illness at the time of vaccination.	Allergies antibiotics and seasonal - no egg allergy.		200603408	1						1	Burning sensation; Chest discomfort; Lymphadenopathy; Urticaria	FLU3~SANOFI PASTEUR~~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299453	11/14/2007	NJ	60.0	60		F	01/08/2007	Initial report received from a patient on 03 January 2007.  A 60 year old, female patient (with no known allergies) developed an ecchymotic area about 1-2 inches below the site 3-4 days after she received Fluzone (lot number unknown, route of administration not reported) in the deltoid on 20 November 2006.  She also stated her muscle appeared to be bulging and complained of soreness and weakness in the arm.  At the time of the vaccination, she was fatigued.  At the time of the report, it was reported the ecchymotic area resolved.  The patient had not recovered.									N	11/20/2006				UNK	UNK	Ataral, Celexa		No known allergies.  Denies medical conditions.		200700027	1						1	Fatigue; Injection site haemorrhage; Muscular weakness; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299456	11/14/2007	PA	73.0	73		F	09/04/2007	Initial report received from a patient on 15 March 2007. A 73 year old, female patient complained of pressure on chest and feeling indigestion, approximately 6 hours (1010 PM) after she received Fluzone (lot number, site and date of administration unknown) intramuscularly in November 2006 at 4PM. The symptoms lasted approximately 2 hours then subsided. She had never experienced this prior to or after this event. She received Fluzone 2 years prior. At the time of the vaccination, she denied any illness and was taking Natalol. She was not treated with any medications. It was reported that she recovered. Follow up information received from a consumer, the patient on 20 July 2007: The patient had her first flu shot (an unspecified manufacturer) on November 2004, given on the side of the arm. The next day she experienced severe injection site swelling about 3 x 3. In the middle of November 2006, she received another flu shot (Fluzone), approximately at 16:00 hours. At about 22:00 hours she started shivering, felt cool with no fever. Then experienced slight pressure on the chest and feeling of indigestion. She was able to breathe normally. The patient never felt like this before. It subsided after 2 hours, she fell asleep and woke up fine the next morning. The patient was taking Nadolol (previously reported as Natalol) as concomitant medication.									Y	11/01/2006	11/01/2006	0		PUB	OTH	Nadolol		No known allergies. She received a unspecified flu shot 2 years prior (November 2004) and experienced injection site swelling. At the time of the vaccination, she denied any illness and was taking Natalol.	Injection site swelling~Influenza (Seasonal) (no brand name)~UN~0.00~In Patient	200700822	1						1	Chest discomfort; Chills; Dyspepsia; No reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299458	11/14/2007	MD	41.0			M	09/13/2007	A 41-year-old male patient had received an injection of Decavac, lot number not reported; an injection of IPOL, lot number not reported; an injection of Menommune, lot number not reported; an injection of Typhim VI, lot number not reported; an injection of Fluzone SV 2006-2007, lot number not reported; and an injection of Hepatitis A Vaccine, manufacturer GSK, lot number not reported; on 20 December 2006. Routes and site of administration were not reported. The patient had received the vaccinations for travel to foreign country where he visited for two weeks. Illness at the time of vaccination was unknown. Almost immediately post-vaccination, the patient complained of dark circles under his eyes, bags under his eyes, and a permanent tired line in his face. Per a letter from the patient dated 13 Augusut 2007, These side effects have not improved or diminished to date. At the time of this report, the patient had not recovered. A new version was created for this case on 31 August 2007 to add that the reporter for this case is the same as for case 2007-03017. No relevant medically significant information was added.									N	12/20/2006	12/20/2006	0		PUB	PUB	Valtrex		The patient had an allergy to aspirin and unknown other medical history. Illness at the time of vaccination was unknown. Other medications included Valtrex.		200702906	1						1	Dark circles under eyes; Drug hypersensitivity; Eye swelling	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~~UNK~UN~UN~POLIO VIRUS, INACT. (IPOL)~1|MEN~SANOFI PASTEUR~~UNK~UN~UN~MENINGOCOCCAL (MENOMUNE)~1|TD~SANOFI PASTEUR~~UNK~UN~UN~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0299459	11/14/2007	MD				F	09/13/2007	This case was reported by a health professional on 04 September 2007.  A female patient with no reported medical history received injections of Decavac, Fluzone, IPOL, Menomune, Typhim Vi, and hepatitis A (manufacturers and lot numbers not reported) on 20 December 2006.  Almost immediately, the patient reported that she experienced dark circles under my eyes, bags under my eyes, a permanent tired line on my face, and hair loss.  Per the reporter, the events were ongoing.  The patient's husband also reported experiencing dark circles under eyes, bags under eyes, and a permanent tired line in the face after receiving the above vaccines; this information is captured in case number 2007-02806.									N	12/20/2006				UNK	UNK					200703017	1						1	Alopecia; Dark circles under eyes; Eye swelling; Skin wrinkling	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~~UNK~UN~UN~POLIO VIRUS, INACT. (IPOL)~1|MEN~SANOFI PASTEUR~~UNK~UN~UN~MENINGOCOCCAL (MENOMUNE)~1|TD~SANOFI PASTEUR~~UNK~UN~UN~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0299460	11/14/2007	IA	74.0	74		F	06/05/2007	A 74 year old, female patient complained of generalized stiffness and body aches, beginning 1 1/2 days after she received an injection of Fluzone (lot number U2212AA), intramuscularly in the deltoid (side not reported) on 21 November 2006. She had a dose of Fluzone in 2005, she did not have any illness at the time of vaccination and she was not on any medications. She saw a rheumatologist on 31 January 2007, with signs and symptoms with 75% improvement but still trouble lifting arms and getting out of the chair. She returned to the family practice on 16 February 2007 and her sedimentation rate was still elevated. The stiffness and aches still persist, mainly in the hands. Her laboratory results were still elevated. The stiffness and aches still persist, mainly in the hands. Her laboratory results were the following: sedimentation rates on 31 January 2007- 24, on 16 February 2007-26. On 31 January 2007: negative for Lyme; negative for ANA negative for Rheumatoid factor; normal CK. Follow-up information received on 21 May 2007 from a health care profession. Per the reporter, it is confirmed that the patient received the Fluzone injection on 21 November 2006 intramuscularly in the deltoid, but the exact site in the deltoid was unknown. Exact duration of the event was not provided. Reportedly, the subject had pain in her arm when she received a Fluzone vaccination in 2005. No other medical information was provided for that adverse event. No further information is expected.				Y					N	11/21/2006	11/23/2006	2	Sedimentation rates on 31 January 2007-24, on 16 February 2007-26. On 31 January 2007: negative for Lyme; negative for ANA; the time of vaccination and she was not on any medications.	PVT	UNK			She had a dose of Fluzone in 2005, she did not have any illness at the time of vaccination and she was not on any medications.	Pain in arm~Influenza (Seasonal) (no brand name)~UN~0.00~In Patient	200700507	1						1	Antinuclear antibody negative; Blood creatine phosphokinase normal; Blood test; Borrelia burgdorferi serology negative; Hypokinesia; Musculoskeletal stiffness; Pain; Pain in extremity; Red blood cell sedimentation rate increased; Rheumatoid factor negative	FLU3~SANOFI PASTEUR~U2212A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299461	11/14/2007	MN	55.0	55		F	03/23/2007	Initial report received on 21 March 2007 from a healthcare professional.  A 54 year old female patent received on 11 October 2006 a dose of Fluzone (lot #U2177AA) and developed generalized hives and raised lump on elbow.  Treated with Benadryl and Tagament.  The event resolved and the patient recovered.  No other vaccines were given concomitantly.  At the time of vaccination the patient had vertigo.  The patient's medical history included multiple environmental life threatening allergies and asthma.  Concomitant medications included ASA, fish oil, sprionolactone, terbutaline prn, Benadryl prn, Singulair, Combavent, and Advair.  The reporter is the same as in case 2007-00863.				Y					Y	10/11/2006				UNK	UNK	ASA, fish oil, spironolactone, terbutaline, Singluair, Benadryl, Combavent, Advair	At the time of the vaccination the patient had vertigo.	The patient's medical history included multiple environmental life threatening allergies and asthma.		200700862	1						1	Mass; Urticaria	FLU3~SANOFI PASTEUR~U2177A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299462	11/14/2007	WI				M	04/24/2007	Initial report received from a health care professional on 17 April 2007.  A male patient (date of birth, age not specified) complained of pain and soreness in the limb where he was vaccinated with Fluzone (lot number, route, site and date of administration not reported).  The symptoms have lasted almost a year.  The patient's recovery status was unknown.									U					MIL	UNK					200701272	1						1	Pain in extremity	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299463	11/14/2007	MA				F	12/19/2006	Initial report received from a pharmacist on 13 December 2006. A female patient (age not reported) experienced sharp, stabbing pain at the injection site after she received Fluzone (lot number, route and site of administration unknown) on 28 November 2006. It was reported that she 'can't lift her arm and she had the pain since vaccination. The patient's recovery status was not reported.									U	11/28/2006				UNK	UNK					200603487	1						1	Injected limb mobility decreased; Injection site pain	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299464	11/14/2007	OR	55.0	55		F	01/24/2007	Initial report received from a nurse on 14 December 2006. A 55 year old, female patient (with a history of allergy to PCN) developed a large 'budge in her neck - left side clavicle bone and her shoulder was large, red and warm at the injection site, the next morning after she received Fluzone (lot number U2550AA) intramuscularly in the left deltoid on 12 December 2006. She was seen by a physician - Advil and heat were prescribed. She did not have any illness at the time of vaccination. At the time of the report, she was not recovered. Follow-up information received on 22 January 2007 from a health care professional. The patient was seen by a physician on 13 December 2006 with a chief complaint of swelling on the left side of the neck anteriorly, just under the clavicle near the left shoulder. The patient stated that she noticed the swelling that morning. She could palpate it, and it was not associated with any injury or pain. At the time of examination the swelling was noted to have extended somewhat below the clavicle near the shoulder. She had no fever, shortness of breath, wheezing, chills or rashes. She had no chest or abdominal pain. She had some general aches and pains, but no specific left-sided pain. Upon examination, the area of swelling was noted to be just lateral to the sternocleidomastoid muscle and just in front of the trapezius muscle. The swelling measured 8 x 7 cm just inferior to the clavicle. There was an area of swelling measuring 8 x 6 cm just inferior to the clavicle and laterally near the shoulder. There was no redness or warmth to either of the involved areas. No tenderness was noted. At the injection site there was some swelling and warmth. The area of swelling measured 2.5 x 3 cm. There was no lymphatic streaking or axillary lymph node involvement noted. There were no neck masses or lymph nodes noted. There was no thyromegaly. The patient was advised to use Aleve and apply ice to the involved areas. No laboratory tests or diagnostics were performed. The events lasted for one week. The patient has recovered from the events. Additional information is not anticipated.				Y					Y	12/12/2006	12/13/2006	1	None	UNK	UNK			Allergic to PCN. From follow-up on 22 January 2007: It is unknown if the patient received previous doses of influenza vaccine. She had a cold prior to the onset of the events, with a mild sore throat, but was much improved.		200603493	1						1	Injection site erythema; Injection site warmth; Local swelling	FLU3~SANOFI PASTEUR~U2550AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299465	11/14/2007	IN	65.0	65		M	03/08/2007	Initial report received from a health care professional on 26 December 2006. A 71 year old, male patient (who was taking chemotherapy) experienced aching of his left upper arm, about 2 hours after he received Fluzone (lot number U2245AA) intramuscularly, in the left arm on 22 December 2006. There was no redness or bruising noted. 24 hours post injection, the patient noticed swelling in the left arm extending from the left upper arm through left forearm. There was slight residual edema noticed in the left arm on 26 December 2006. No redness was noticed. The patient no longer has pain in the arm. He did not have any illness at the time of vaccination. Follow-up information received on 08 March 2007 from a health care professional. The case was reviewed, there is no additional information to add. No further information is expected.									N	12/22/2000	12/22/2006	2191		UNK	PVT	Chemotherapy		The patient takes chemotherapy - no info was given as to why. He had 'soreness in arm' after he received Pneumo, 23-valent (manufacturer unknown) when he was 69 years old.	Pain in arm~Pneumo (no brand name)~UN~69.00~In Patient	200603636	1						1	Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2245A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299466	11/14/2007	TX	6.0	6		M	05/04/2007	Initial report received from a pharmacist on 28 December 2006. A 6 year old, male patient, developed eye tics approximately 2 weeks post vaccination with Fluzone (U2180AA, route of administration not reported) in the right thigh on 10 October 2006. It was not known if the patient had any illness at the time of vaccination. At the time of the report, it was unknown if the patient recovered. No other information was available at the time of the report. Follow-up information received on 30 April 2007. The patient did not have any illness at the time of the vaccinations. It was reported the patient received a hepatitis injection (not specified) 2 weeks after the flu vaccine.									U	10/10/2006	10/24/2006	14		UNK	UNK			Follow-up information received on 30 April 2007. The patient did not have any illness at the time of the vaccination.		200603648	1						1	Eye movement disorder	FLU3~SANOFI PASTEUR~U2180AA~UNK~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|UNK~UNKNOWN MANUFACTURER~~UNK~UN~UN~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA		Influenza
0299467	11/14/2007	PA				U	02/01/2007	Initial report received from a physician on 26 January 2007. A patient (age and gender not reported) experienced a black dot after receiving Fluzone (lot number unknown, site, route and date of administration not reported). The patient's black dot persisted over a month. Additional information was not provided.									Y					UNK	UNK					200700248	1						1	Injection site discolouration	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299468	11/14/2007	DC	51.0	51		F	10/31/2006	Initial report received on 16 October 2006 from a health care professional. A 51-year-old female patient had received an intramuscular, left deltoid injection of Fluzone, lot number U2194AA, on 12 October 2006. Two days later, the patient experienced swelling, redness, itching, and warmth to touch at the injection site. The event did not require medical examination. At the time of this report, the patient had not recovered.									N	10/12/2006	10/14/2006	2		UNK	UNK			The patient had no illness at the time of vaccination.		200602686	1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2194AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299469	11/14/2007	TX	34.0	34		F	03/07/2007	Initial report received on 17 October 2006 from a health care professional. A 34-year-old female patient had received an intramuscular injection of Fluzone SV 2006-2007, lot number U2239AA, on 17 October 2006. The patient had no illness at the time of vaccination. Within one hour following vaccination, the patient complained of difficulty breathing and chest tightness. Vital signs were within normal limits. Oxygen saturation was 100%. The patient had no visible symptoms, no hives and no stridor. She was treated with Benadryl. The reporter indicated that the event did not require any emergency room or doctor visit. Recovery status was unknown. Follow-up information received on 05 March 2007 from a health care professional. It was unknown whether the patient had any diagnostic testing performed. The reporter noted questionable anxiety.				Y					Y	10/17/2006	10/17/2006	0		PVT	PVT			The patient had a history of allergies to erythromycin, Vicodin and mve.		200602701	1						1	Chest discomfort; Dyspnoea	FLU3~SANOFI PASTEUR~U2239AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299470	11/14/2007	NV	41.0			F	03/12/2007	Three patients with no current illnesses, had received a left deltoid, intra-muscular injection of FLUZONE SV '2006-2007 USP, lot number U2193AA, on 16 October 2006 at 16:00 pm. The next day, they experienced a metallic taste in their mouths. Past medical history and use of other medications were not provided for any the the patients. Diagnostics and treatments received were not reported. The recovery status of patients is unknown. Follow-up information received on 06 March 2007. One (I) female patient, 41 years of age was identified. She did not have any illness at the time of vaccination and was not on any medications. She did not have any other vaccinations within 4 weeks of receiving Fluzone.									U					UNK	UNK			These patients had no illness at the time of the vaccination on 16 October 2006. Information regarding pre-existing medical history and use of other medications were not provided. Follow-up information received on 06 March 2007. One (1) female patient 41 years of age was identified. She did not have any illness at the time of vaccination and was not on any medications.		200602707	1						1	Dysgeusia	FLU3~SANOFI PASTEUR~U2193AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299471	11/14/2007	FL	54.0	54		F	10/31/2006	Initial report received on 18 October 2006 from a health care professional.  A 54-year-old female patient, with no current illnesses, had received a right arm dose of FLUZONE SV '2006-'2007 USP, lot number U2197AA, on 16 October 2006.  The reporter was not sure if the injection was administered intra-muscular or subcutaneous.  Approximately one day later, the patient developed a reddened area at the injection site that was about two inches in diameter and tender.  The patient was treated by a physician and diagnosed with mild cellulitis.  Diagnostics and treatments received were not reported.  The patient's recovery status is unknown.				Y					U	10/16/2006	10/17/2006	1		UNK	UNK			The patient denied any illnesses, and had no known allergies at the time of the vaccination on 10 October 2006.  The reporter was unsure if the patient had received any other vaccinations within four weeks of the vaccination on 10 October 2006.		200602716	1						1	Cellulitis; Injection site erythema	FLU3~SANOFI PASTEUR~U2197A~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299472	11/14/2007					U	10/31/2006	Initial report received on 19 October 2006 from a health care provider.  A patient (age and gender not reported) had received an injection of Fluzone SV, lot number not reported, on an unspecified date.  At an unknown time post-vaccination, the patient developed fever blisters.  Additional information was not provided.  Recovery status was unknown.									U					UNK	UNK					200602725	1						1	Oral herpes	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299473	11/14/2007	CA				U	12/12/2006	Initial report received on 19 October 2006 from a health care professional.  Approximately five to six patient had received a deltoid injection of Fluzone SV 2006-2007, lot number U2193AA, on 18 October 2006.  Immediately post-immunization, a black dot appeared at the injection site.  The administration products used included a 3ml, BD syringe (#309585) with a 23 gauge, one inch needle (#305902).  Per the reporter, following their own testing, the silicone on the needle was suspected as the cause.  Outcome for these patients was reported as unknown.  Follow-up information received on 21 November 2006.  The patients (no individual patient identification provided) did not have any illness at the time of vaccination.  The vaccine was purchased with private funds.  Follow-up information received on 11 December 2006 from a health care professional.  The case was reviewed, and there was no additional information at this time.									U	10/18/2006	10/18/2006	0		PVT	PVT		Follow up information received on 21 Nov 2006.  The patients did not have any illness at the time of vaccination.	Patient histories were unknown.		200602727	1						1	Injection site discolouration	FLU3~SANOFI PASTEUR~U2193A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299474	11/14/2007	PA	54.0	54		F	11/28/2006	Pain localized injection site reaction				Y					Y	10/13/2006	10/13/2006	0		PVT	OTH	Prednisone				200602759	1						1	Injection site pain; Injection site reaction	FLU3~SANOFI PASTEUR~U2195A~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299475	11/14/2007	FL	54.0	54		F	03/12/2007	Initial report received on 24 October 2006 from the patient who is also a health care professional.  A 56-year-old female patient, with a past medical history of asthma, had received an intramuscular, left deltoid injection of Fluzone SV 2006-2007, lot number U2240AA, on 05 October 2006.  Six hours later, she developed a fever of 101 degrees Fahrenheit, body aches, and malaise.  Over the next two days, her temperature was 99 degrees Fahrenheit, and she continued to have body aches.  Four days post-vaccination, she experienced severe shoulder spasms which was treated with Motrin.  On 11 October 2006, the patient had severe muscle aches, muscle weakness in her back and sacrum, and difficulty walking due to muscle aches.  She was examined by her physician and treated with Motrin, and muscle relaxers x three days.  The patient was home from work due to fatigue from 06 October 2006 to 21 October 2006.  On 21 October 2006 and 22 October 2006, her toes and fingers were tingling.  As of 24 October 2006, the patient continued to have fatigue and muscle weakness in her back.  At the time of this report, the patient had not recovered.  Follow-up information received on 09 March 2007 from the patient who is also a health care professional.  The patient had no illness at the time of vaccination.  No diagnostic testing was performed.  The patient has returned to work.  Recovery took several weeks.  Per the reporter, she is now recovered.				Y					Y	10/05/2006	10/05/2006	0		PVT	UNK			The patient had a history of asthma.		200602771	1						1	Body temperature increased; Fatigue; Gait disturbance; Malaise; Muscle spasms; Muscular weakness; Myalgia; Pain; Paraesthesia; Pyrexia	FLU3~SANOFI PASTEUR~U2240A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299476	11/14/2007	CO	30.0	30		F	11/09/2006	Pupil dilated, eye red.  Initial report received on 24 October 2006 from a health care professional.  A 30 year-old female patient, with a medical history of allergies, had received an intramuscular, right deltoid injection of Fluzone SV 2006-2007, on 23 October 2006.  There was no illness at the time of vaccination, and the patient was on no other medications.  The next day, she developed a red and dilated eye.  It was not specified which eye was effected.  The patient had not yet seen a physician.  The patient had not recovered.									N	10/23/2006	12/24/2006	62		UNK	UNK			The patient had a history of allergies.		200602772	1						1	Mydriasis; Ocular hyperaemia	FLU3~SANOFI PASTEUR~U2218A~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299477	11/14/2007	NJ				M	12/28/2006	Initial report received from a physician on 25 October 2006.  A male patient (age not reported), developed swelling of the eyes and itching of the upper extremities, 1/2 hour after he received Fluzone (lot number U2199AA) on 23 October 2006.  He went to the emergency room (he works as an EMT and was at the hospital) and was treated with Prednisone and Benadryl.  He was not on any concomitant medications.  He has had similar reactions in the past but is unclear to what.  His symptoms have resolved.  Follow-up information received ion 27 December 2006 from a health care professional.  Under the description of the adverse event, the reporter had written seasonal allergies.  No other medically relevant information was provided.				Y					Y	10/23/2006	10/23/2006	0		UNK	UNK			He has had similar reactions in the past but is unclear to what.		200602805	1						1	Eye swelling; Pruritus	FLU3~SANOFI PASTEUR~U2199A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299478	11/14/2007	VA	43.0	43		F	06/05/2007	Initial case received on 25 October 2006 from a health care professional.  A 43-year old female patient, with a history of asthma and allergy to peanuts, had received a left deltoid, intramuscular injection of Fluzone SV 2006-2007, on 18 October 2006.  At an unspecified time post-vaccination, the patient developed a three inch swollen red area.  She complained it was hot and swollen; and, once the redness subsided, she complained of pruritus.  At the time of this report, recovery status was unknown.  Follow-up information received on 29 May 2007 from the patient who is a physician.  The patient had no illnesses at the time of the vaccination on 08 October 2006.  No relevant diagnostic tests or laboratory data were performed for the adverse events.  It was reported that the patient recovered from these adverse events (date of recovery was not provided).  No further information is expected.									Y	10/18/2006				PVT	UNK			The patient had a history of asthma and an allergy to peanuts.		200602807	1						1	Erythema; Oedema peripheral; Pruritus; Skin warm	FLU3~SANOFI PASTEUR~U2273A~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299484	11/14/2007	PA	2.0	2	1	M	12/14/2006	A 2 year old male patient had received on 23 October 2006 Fluzone (lot number U2204AA), intramuscular, into the left deltoid (dose not provided). Within 24 hours, on 24 October 2006, the patient developed swollen and reddened area of the entire upper arm. The patient was seen by a physician on 24 October 2006 and treated with oral paracetamol (Tylenol) and Diphenhydramine hydrochloride (Benadryl). At the time of this report (26 October 2006) the patient had not recovered. The patient did not received any concomitant medications. The patient experienced fever, swollen face, hands and feet post vaccination with MMR and Varicella vaccines. Denies any illness at the time of vaccination. Denies concomitant medications. Possible allergy neomycin, denies other allergies. The patient had received Fluzone vaccine last year (2005). Follow-up information received on 12 December 2006. The Fluzone vaccine administered on 23 October 2006 was a 0.5 mL dose, and it was the third dose the patient had received. The patient had not received any other vaccinations within four weeks of that vaccination. Per the reporter the patient fully recovered from these adverse events. The patient experienced rash, not fever as previously reported with MMR and Varicella vaccines. No further information is expected.				Y					Y	10/23/2006	10/23/2007	365		PVT	PVT	Fluoride, Multivitamin		The patient experienced ever, swollen face, hands and feet post vaccination with MMR and Varicella vaccines. Denies any illness at the time of vaccination. Denies concomitant medications. Possible allergy to neomycin, denies other allergies. Had Fluzone vaccine last year (2005).	Rash~Measles + Mumps + Rubella + Varicella (ProQuad)~UN~0.00~In Patient	200602813	1						1	Erythema; Oedema peripheral; Pyrexia; Rash; Swelling face	FLU3~SANOFI PASTEUR~U2206A~3~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299485	11/14/2007	NJ	4.0	4		F	11/13/2006	Initial report received on 30 October 2006 from a health care professional.  A four-year-old female child, with a concurrent upper respiratory infection, and no known allergies, had received a fourth dose, left thigh, intra-muscular injection of FLUZONE SV '2006-'2007 USP, lot number U2237AA, on 27 October 2006.  Approximately four hours post-immunization, the patient developed a fever of 103.0 degree Fahrenheit, minimal cough, and complained of bilateral eye pain.  No diagnostics were performed, and treatments received were not reported.  The patient was evaluated by the physician three days later, and her neurological exam was normal, her eye pain was gone, and her fever had gone down to 101.0 degrees Fahrenheit.  No diagnostics were performed, and treatments received were not reported.  Reportedly, the patient had experienced a previous temperature of 103.0 degrees Fahrenheit at 18 months of age (2003) after receiving a vaccine (trade name of vaccine not reported).  At the time of this report, it was unknown if the patient had fully recovered from these adverse events.  The reporter for this case is the same as for cases 2006-02858, and 2006-02860.				Y					U	10/27/2006	10/27/2006	0		PVT	UNK	She was not taking any other medications at the time of the vaccination.		The patient had an upper respiratory infection just prior to the vaccination on 27 October 2006.  She has no known allergies.  The patient had previously experienced a fever of 103.0 degrees Fahrenheit at 18 months of age (2003) after receiving a vaccine (trade name of the vaccine was not reported).	fever~Influenza (Seasonal) (no brand name)~UN~1.50~In Patient	200602859	1						1	Cough; Eye pain; Pyrexia	FLU3~SANOFI PASTEUR~U2237A~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299486	11/14/2007	NH				F	11/03/2006	A female patient (age not reported) experienced a metallic taste in mouth within 24 hours after receiving Fluzone (lot number U2242AA, date, route and site of administration not reported). It was unknown if the patient recovered. This case has the same reporter as case 2006-02857.									U					PVT	UNK					200602862	1						1	Dysgeusia	FLU3~SANOFI PASTEUR~U2242A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299487	11/14/2007	PA	66.0	66		M	12/07/2006	A 66-year-old male patient, with an allergy to dyes, and Celebrex; and who has reflux disease, had received a right deltoid, intra-muscular injection of FLUZONE SV 2006-2007 USP, lot number U2187AA, on 30 October 2006. Within one hour post-immunization, the patient experienced a strong metallic taste in his mouth. The next day, the metallic taste continued and he complained of a headache. He had no other complaints. Per the reporter, a 23 gauge, 1 inch needle was used for the injection. The patient did not seek medical attention, and no diagnostic tests or laboratory work were performed. At the time of this report, the patient had not recovered. Follow-up information received on 06 December 2006 from a health care professional. The patient recovered.									Y	10/30/2006	10/30/2006	0		PVT	UNK	Nexium, Zantac		The patient had no illnesses at the time of the vaccination on 30 October 2006. He has a history of allergy to dye and Celebrex. He has a history of Reflux disease.		200602892	1						1	Dysgeusia; Headache	FLU3~SANOFI PASTEUR~U2197A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299488	11/14/2007	MI	69.0	69		F	11/15/2006	Cluster of 2 patients (patient identified in case 2006-02903; patient not identified in case 2006-02904).  This case has the same reporter as case 2006-02904.				Y					Y	10/20/2006	10/20/2006	0		PVT	PVT	Synthroid, Butalol, herbs		Allergy to sulfa, mild, dust, animals, cats.  Asthma.		200602903	1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2244A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299489	11/14/2007	MI				U	11/15/2006	Injection site itching.  Cluster of 2 patients.				Y					Y	10/20/2006				PVT	PVT					200602904	1						1	Injection site pruritus	FLU3~SANOFI PASTEUR~U2244A~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299490	11/14/2007	IA				U	11/07/2006	Initial report received on 02 November 2006 from a health care provider.  An unspecified number of patients had received an intramuscular injection of Fluzone SV 2006-2007, lot number U2164AA, on unspecified dates.  Black dots were noted as soon as the needle was removed following administration of the vaccine.  The reporter was unsure of the number of patients that had experienced this event.  The syringe used was a BD safety glide, and the needle was a 25 gauge, one inch needle.  Recovery status was unknown.									U					UNK	UNK					200602918	1						1	Skin discolouration	FLU3~SANOFI PASTEUR~U2164A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299492	11/14/2007	UT				M	11/20/2006	Initial report received on 10 October 2006 from a health care professional.  A male patient (date of birth and age were not reported) had received a left deltoid, intra-muscular injection of FLUZONE SV '2006-'2007 USP, lot number unknown; and a left deltoid, intra-muscular injection of Pneumovax, manufacturer Merck, lot number not reported, on 09 October 2006.  Approximately five hours post-immunization, the patient developed redness and swelling approximately six inches below the arm pit to the elbow.  He denied any other symptoms or local reaction to the actual injection site.  He required medical evaluation, but diagnostics and treatments received were not reported.  At the time of this report, the recovery status of the patient was unknown.  Another patient at the same facility had the same type of reaction that is reported in case 2006-02657.  Follow-up information received on 17 November 2006 from a health care professional.  As per the reporter, it was determined that it was not the flu shot, but the Pneumovax shot.  Further information is not anticipated.				Y					U	10/09/2006				UNK	UNK					200602658	1						1	Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0299493	11/14/2007	TX	55.0	55		M	10/10/2006	A 55-year-old male patient, with no known allergies, had received a dose of Fluzone SV 2006-2007 on 03/Oct/2006.  The route and site of administration were not reported.  Approximately 15 to 20 minutes post-immunization, the patient developed throat discomfort and tingling in his hands and face.  The patient denied any shortness of breath or difficulty in breathing.  Treatment received was not reported.  The recovery status of the patient was reported as unknown.									U	10/03/2006	10/03/2006	0		UNK	UNK			It was unknown if the patient had any illnesses, or was using any other medications at the time of the vaccination on 03/Oct/2006.  The patient had no known allergies.  It was unknown if the patient had received any other vaccinations within four weeks of the vaccination on 03/Oct/2006.		200602586	1						1	Paraesthesia; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U2192A~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299498	11/14/2007	MD	29.0	29		F	07/12/2007	Initial report received on 04 April 2007, from a health care professional.  A 29 year old female patient received on 16 December 2002, 0.5 ml Fluzone (lot #U0931AA) (site, side and route of administration not reported), to protect against flu.  The patient was pregnant at that time.  No adverse event was reported for the patient.  The patient delivered a baby (unknown gender) on 25 May 2003, vacuum assisted.  The child had developmental disabilities.  The patient's medical history included: hypothyroid and sclerosis.  The patient's concomitant medication included: Synthroid.  No other information was reported.  Follow-up information received on 02 July 2007 from a health care professional.  Fluzone SV 2002-2003 had been administered as a first dose, intramuscular, deltoid injection on 10 December 2002 (previously reported a 15 December 2002).  The patient had experienced pregnancy induced hypertension while in the hospital and was administered MgSO4.  The reporter had also indicated that the patient did not experience any adverse event.  Child case number is 2007-01043.				Y					U	12/10/2002	05/25/2003	166		PVT	UNK	Synthroid		hypothyroid, scoliosis		200701508	1						1	Drug exposure during pregnancy; Pregnancy induced hypertension	FLU3~SANOFI PASTEUR~U0931A~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299499	11/14/2007	NV	50.0	50		M	08/30/2007	Initial report received on 04 June 2007 from a health care professional.  A 50-year-old male patient, with a cardiac history which included cardiac stint placement 18 months prior to vaccination, had received a left deltoid injection of Fluzone SV 2006-2007, lot number not reported, on an unspecified date.  On an unspecified date post-immunization, the patient experienced a metallic taste in his mouth.  There was no illness at the time of vaccination, and no further care was required.  At the time of the report, recovery status was not reported.  Follow-up information received on 16 July 2007 from a health care professional.  The patient was vaccinated on 02 November 2006, and the event was experienced on that day and the following day.  No diagnostic testing was performed.  Fluzone SV 2006-2007 lot number was U2193AA.  The duration of the event was 18 hours.  The patient recovered from the event.  The reporter in this case is the same as in cases 2006-02707 and 2007-02050.									Y	11/02/2006	11/02/2006	0		OTH	PUB			The patient had a cardiac history which included stint placement 18 months prior to vaccination.  He had received no other vaccinations within four weeks of the 02 November 2006 vaccination.		200702049	1						1	Dysgeusia	FLU3~SANOFI PASTEUR~U2193A~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299500	11/14/2007	NV	53.0			F	07/31/2007	Initial report received on 04 June 2007 from a health care professional.  A 53-year-old female patient, with no illness at the time of vaccination, had received a left deltoid injection of Fluzone SV 2006-2007, lot number not reported, on an unspecified date.  On an unspecified date post-immunization, the patient experienced a metallic taste in her mouth.  Medications included Claritin, pseudopherine, and bio-identical hormone replacement.  No further follow-up was required after the vaccination.  At the time of this report, recovery status was not reported.  Follow-up information received on 30 July 2007 from a health care professional.  The date of vaccination was 30 October 2006, and the adverse event onset was 30 October 2006, four hours post-immunization.  The Fluzone lot number was U2193AA, and Fluzone was administered intramuscularly in the left deltoid.  Per the reporter, the duration of the event was 36-40 hours, and the patient recovered.  The reporter in this case is the same as in cases 2006-02707 and 2007-02049.									Y	10/30/2006	10/30/2006	0		UNK	UNK	Claritin, pseudopherine, bio-identical hormone replacement		The patient had a history of albuterol use four years ago.		200702050	1						1	Dysgeusia	FLU3~SANOFI PASTEUR~U2193A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299501	11/14/2007	PA				U	11/15/2006	A cluster of over 100 patients out of an unspecified number of vaccinees from a hospital, who received Fluzone (lot number U2199AA) and experienced black dots at injection site.  Initial report received from a nurse at a hospital on 02-Nov-2006.  Over 100 unidentifiable patients received on an unspecified date, Fluzone (U2199AA) (multidose vial) into the deltoid (dose, side and route of administration were not reported) and experienced black dots at injection site immediately after the dose of was administered.  No corrective treatment was reported.  Patients outcome was not reported.  SafetyGlide 23g, 1, 25g 5/8 needles were used with Safety Glide syringe system (lot number for the needle used was not reported).  The alcohol brand was unknown, but the reporter said it was a generic brand, started with M.  The black mark appeared all the way through using the vial, with no difference of the dose number.  The black spot appeared immediately after vaccination, it was unknown if it disappeared or how long it lasted.  The reporter had not ever seen this happen with any other product vial.  The black dots were noticed by all five nurses that administered the vaccines.  The reporter had not ever seen this happen in the past year.  The reporter did not track the incident, but was willing to do so if the event continued.  112 vials were purchased and 15 were used so far.  The event had been occurring routinely, but it was most noticeable on higher skinned people.  The reporter was not sure if it happened with every dose.  The reporter did not have any empty vials (all had been discarded), but stated they were doing many immunizations so they would have more empty vials by the end of the day (02 November 2006).  Concomitant vaccinations, medical history and prior exposure to Fluzone were not reported for the patients.									U					UNK	UNK					200602935	1						1	Immediate post-injection reaction; Injection site discolouration	FLU3~SANOFI PASTEUR~U2199AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299502	11/14/2007	CA				U	11/15/2006	A cluster of 4 cases out of an unspecified number of vaccinees, who received Fluzone (lot number U2177AA) and experienced adverse events which reported by the same physician. Initial report received from a physician on 02 November 2006. Two unidentified patients received Fluzone (lot number U2177AA) on an unspecified date, into the deltoid (side, site and dose was not reported) and experienced sore throat, muscle and joint aches for one week. No corrective treatment was reported. The patients had recovered. The patients' medical history, concomitant vaccines and prior exposure to Fluzone were not reported. This report (for the two unidentifiable patients) has the same reporter as cases 2006-02938 and 2006-02641.				Y					Y					UNK	UNK					200602937	1						1	Arthralgia; Myalgia; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U2177A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299503	11/14/2007	CA	68.0	68		F	12/14/2006	A 68 year old female patient received Fluzone (lot number U2243AA) on the first week of October 2006. Shortly after, the same day, she experienced upper arm discomfort and lower leg weakness. No corrective treatment was reported. The patient had recovered. No concomitant vaccines were reported. The patient had history of RA (probably Rheumatoid Arthritis). The patient had many previous doses of Fluzone with no reported symptoms. Follow-up information received on 11 December 2006. The patient was taking Plaquenil, Coumadin, Synthroid, Fosamax, Zetia, Wellbutrin, and HCTZ at the time of vaccination in October 2006. She had not received any other vaccinations within four weeks of that vaccination. No relevant diagnostic tests/laboratory data were performed. No further information is expected.									Y	10/01/2006	10/01/2006	0		OTH	PVT	Plaquenil, Coumadin, Synthroid, Fosamax, Zetia, Wellbutrin, HCTZ		History of RA (probably Rheumatoid Arthritis). Many previous doses of Fluzone.		200602939	1						1	Limb discomfort; Muscular weakness; No reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~U224DA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299505	11/14/2007	OH	34.0			M	02/08/2007	A 34 year old, male patient (with a history of having many flu vaccine dose in the past) developed a black ring around the needle injection site immediately after he received an intramuscular, injection of Fluzone (lot number U2195AA) in the right deltoid on 03 November 2006. The RN who administered the vaccine reported seeing the adverse event. The patient had no pain. The nurse reported there was no sign of the black dot several hours later. One type of syringe, a B-D Safety Glide syringe, was used with a B-D 23 Gauge (lot number 604873) needle. Abco alcohol swipes out of Mashbills, TW were used. It was not known if the black marks appeared mostly at the first or second dose of the vial or more towards the end of the vial. It was not known low long the mark lasted. This has not been seen with any other product vial. There were 4 RN's vaccinating. This has not happened in the past years. Out of 50-60 doses given, she has een this 10-15 times. The patient were unaware, with no complaints. Follow-up information received on 05 February 2007. The reporter was not sure if the black mark occurred with the first or later doses. The black mark would go away after a few hours. No other known event occurred.									Y	11/03/2006				UNK	UNK			Had many flu vaccine doses in the past.		200602945	1						1	Immediate post-injection reaction; Injection site discolouration	FLU3~SANOFI PASTEUR~U2195A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299506	11/14/2007	PA	53.0	53		F	12/05/2006	Initial report received from a nurse, on 03 November 2006.  A 53 year old female patient, received Fluzone (lot number U2164AA) into the left deltoid, on 01 November 2006.  A few hours after immunization, on 01 November 2006, the patient experienced red and swollen area, at injection site.  24 hours (post vaccination) (on 02 November 2006), the injection site was warm to touch.  48 hours (post vaccination), on 03 November 2006, the injection site was itchy and there was a 9-19 cm red area at the left deltoid, of the injection site.  No corrective treatment was reported.  At the time of the report (03 November 2006), it was unknown if the patient had recovered.  The patient's medical history included unspecified allergies.  The patient did not have any illness at the time of vaccination.  The patient's concomitant medications included Zyrtec and Singulair.  Prior exposure to Fluzone was not reported.  Follow-up information received on 04 December 2006.  Per the reporter, the patient recovered from these adverse events as reported by a friend of the patient on 01 December 2006.  No further information is expected.									Y	11/01/2006	11/01/2006	0		OTH	OTH	SINGULAIR; ZYRTEC		Unspecified allergies.  No illness at vaccination time.		200602946	1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2164AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299508	11/14/2007	TN	7.0	7		F	03/12/2007	Initial report received from a health care professional, on 08 November 2006.  A 7 year old female patient, received on 31 October 2006 Fluzone (lot number U2239AA) (multidose vial), intra-muscular, into the right deltoid.  On 03 November 2006, three days later, she experienced red raised rash and itchiness at injection site.  No systemic reaction was reported.  The patient required a doctor visit.  Corrective treatment was not reported.  The patient's outcome was unknown.  No concomitant vaccinations were given.  No information on prior exposure to Fluzone was reported.  The patient had allergy to amoxicillin and no other medical conditions.  The patient's concomitant medications included Zertec as needed (PRN).  No illness at vaccination time were reported.  Follow-up information received on 12 March 2007 from a health care professional.  Number of previous doses of Fluzone SV 2006-2007 was none.  Concomitant medication was amended to Zyrtec (previously reported as Zertec).  At the time of this report, the patient had recovered.				Y					Y	10/31/2006	11/03/2006	3		PVT	PVT	ZYRTEC		No illness at vaccination time, no medical conditions, no concomitant vaccinations were given, unsure of any adverse events occurred post prior vaccinations.  Allergic to amoxicillin.		200603007	1						1	Injection site pruritus; Injection site rash	FLU3~SANOFI PASTEUR~U2239AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299509	11/14/2007	CA	46.0	46		F	12/20/2006	Initial report received from a health care professional on 09 November 2006.  A 46 year old, female patient developed blister-like lesions), 24 hours after she received Fluzone (lot number U2251AA) intramuscularly in the right deltoid on 07 November 2006.  The blister-like lesions appeared on the opposite forearm, upper arm and trunk.  At the time of the report, it was unknown if the patient recovered.  Follow-up information received on 15 December 2006.  The patient did not have any illness at the time of vaccination.  The patient stated the lesions resolved approximately 2 weeks after the vaccine was given, but she did experience moderate URI symptoms with fever for 3 days after the vaccine which also resolved.  The patient recovered - approximately 21 November 2006.				Y					Y	11/07/2006	11/08/2006	1		PVT	UNK	ALDACTONE, CARDIZEM DS, HYDROCHLOROTHIAZIDE, LISINOPRIL, LASIX, REGLAN, COREG, CLARITIN, METFORMIN, SINGULAIR, LAMISIL, NEXIUM, DIOVAN, COLACE, ASTELIN NASAL SPRAY, DURAMACE SMOOTH OIL HYDROCORTISONE CREAM .25%, ASMANEX INHALER, ZOPANEX HS		Allergies: Keflex, Ceclor, Septra, vancomycin, Latex tape, milk products.  Medical conditions: Asthma, Diabetes, Cardiomyopathy, Hypertension.  Follow-up information received on 15 December 2006.  The patient did not have any illness at the time of vaccination.		200603016	1						1	Blister; Pyrexia; Skin lesion; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~U2251AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299510	11/14/2007	PA	48.0	48		F	12/12/2006	Initial report received from a patient on 13 November 2006.  A 48 year old, female patient experienced hives red, burning sensation of hands, felt faint and palpitations, 2 days after she received Fluzone (lot number, site and route of administration not reported) on 02 November 2006.  She had an ear/sinus infection at the time of vaccination.  The signs and symptoms began 1/2 hour after she took Omniceph (antibiotic) for an ear infection.  The duration of the signs and symptoms was 2 hours.  As per the reporter, the patient recovered.  Follow-up information received on 11 December 2006 from a health care professional.  Fluzone SV 2006-2007, lot number U2248AA, was administered intramuscularly in the right deltoid.  The patient had an ear and sinus infection at the time of vaccination.				Y					Y	11/02/2006	11/04/2006	2		PVT	UNK	PREDNISONE, OMNICEPH	She had an ear/sinus infection at the time of vaccination.	No known allergies; Ear tubes, recurrent ear infections.		200603057	1						1	Burning sensation; Dizziness; Erythema; Palpitations; Urticaria	FLU3~SANOFI PASTEUR~U2248AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299512	11/14/2007	VA				F	11/17/2006	Cluster of 10 cases of injection site adverse event, out of unspecified vaccinees, who received Fluzone (lot number U2253AA).  The reporter was one of the patients.  Initial report received from a health care professional, on 13 November 2006.  A female patient received Fluzone (lot number U2253AA) (dose, site and side of administration not reported), on an unspecified date.  24-72 hours post vaccination, the patient experienced tenderness, redness and swelling at injection site, all of a size of 6 cm area.  The patient experienced a large bruise as well.  The patient recovered within approximately 24 hours.  No corrective treatment was reported.  Concomitant vaccinations, medical history and prior exposure to Fluzone were unknown.  The reporter is the same as in case 2006-03092.									Y					UNK	UNK					200603093	1						1	Injection site bruising; Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2253AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299513	11/14/2007	NY	42.0			F	12/20/2006	Initial report received on 13 November 2006, from a physician, who contacted the company with request for medical information and to report an adverse event.  A 42 year old female patient, received Fluzone (lot number U2243AA) (multidose vial, site, side and dose not reported) on 02 November 2006, at the physician's office.  Two days later, on 04 November 2006, the patient experienced tender pretibial nodules on the right side.  On 09 November 2006, she was diagnosed with erythema nodosum.  No corrective treatment was reported.  At the time of the report (13 November 20060, the patient had not recovered.  Information on concomitant vaccines, prior exposure to Fluzone, illnesses at the time of the vaccination and medical history was not reported.  The patient took no prescription and had no over the counter medication recently.  Blood work was pending.  Follow-up information received on 15 December 2006.  The patient received 0.5cc Fluzone intramuscularly in the left deltoid.  It was unknown if the patient received Fluzone before.  She did not have any illness at the time of vaccination.  The reporter had a verbal follow-up with the patient on 07 December 2006, there was no change.  The patient had negative blood work for C3, Compl. total, CRP, ASO.									N	11/02/2006			The patient had negative blood work for C3, Compl. total, CRP, ASO.	UNK	UNK			The patient took no prescriptions and had no over the counter medication recently.		200603094	1						1	C-reactive protein normal; Complement factor C3; Erythema nodosum; Nodule; Streptococcal identification test; Tenderness	FLU3~SANOFI PASTEUR~U2243AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299514	11/14/2007	CO	21.0			F	02/07/2007	Initial report received from a health care professional, on 13 November 2006.  A 21 year old female patient, received on 20 October 2006, intramuscular vaccination of Fluzone (lot number U2240AA) (multidose vial), into the left deltoid.  4 hours post vaccination, on 20 October 2006, the patient had pain in her left arm.  The patient was seen in the office, three days later, on 13 November 2006 and the pain continued.  The patient did not have swelling, redness or weakness.  The patient was prescribed Advil and heat.  No concomitant vaccines were reported.  The patient had no illnesses at the time of vaccination.  No concomitant medications were reported.  The patient received Fluzone previously.  No information on adverse events was reported.  Follow-up information received on 31 January 2007.  The patient received Fluzone previously in the fall of '05, '04 and '03.  She received 0.1ml of Tubersol (lot number C2079AA) subdermally in the left forearm on 19 September 2006.  She did not have any illness at the time of Fluzone vaccination, she was taking mirtazapine 7.5 mg daily.  On 13 November 2006, the patient complained of left arm pain.  She complained of weakness in the entire arm with an inability to lift arm completely above head.  The plan was a trial of ibuprofen 400 mg BID and heat 20 minutes two times daily.  On 14 November 2006, the patient complained the arm was numb.  On 27 November 2006, she visited a physician for the same complaints.  On 25 January 2007, the patient reported her arm was slowly getting better.  She almost has full range of motion, except for anything up high.  She still can't hold anything heavy using only that arm, and some days it will ache all day.  She still has some tenderness in the area of the shot.  She is not on any medication now or seeing a physician for her arm.  She has not had a doctors visit since November.  She did not have physical therapy.  Follow-up information received on 23 February 2007 from a health care professional.  Demographic information was received.  Per the reporter, the case was reviewed and no additional information is available at this time.									N	10/20/2006	10/20/2006	0		OTH	PVT	MERTAZAPINE		Received previously Fluzone.  The patient had no illnesses at the time of vaccination.  No concomitant medications were reported.  Follow-up information received on 31 January 2007.  The patient received Fluzone previously in the fall of '05, '04 and '03.  She received 0.1ml of Tubersol (lot number C2079AA) subdermally in the left forearm on 19 September 2006.  She did not have any illness at the time of Fluzone vaccination, she was taking mirtazapine 7.5 mg daily.		200603095	1						1	Hypoaesthesia; Injected limb mobility decreased; Injection site pain; Muscular weakness; Pain in extremity	FLU3~SANOFI PASTEUR~U2240AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299516	11/14/2007	NJ	25.0	25		F	12/22/2006	Initial report received from a patient on 15 November 2006.  A 25 year old, female patient developed a sore throat, runny nose, cough and malaise for 5 days, approximately 24 hours after she received Fluzone (lot number unknown and route of administration not reported) in the left deltoid on 07 November 2006.  She also received a tetanus booster (Tradename, manufacturer, lot number and route of administration not reported) at the right deltoid.  She also complained of soreness at the sites of both injections.  It was reported that the adverse events had resolved.  Follow-up information received on 18 December 2006.  The patient received Fluzone, lot number U2285AA, intramuscularly and Td toxoids, manufacturer Massachusetts Public Health Biologic Laboratories, lot number Td-165, intramuscularly.  The patient previously received Fluzone on 16 September 2004 and no symptoms were observed.  Her medical history was hay fever, hernia, hemorrhoids. The patient did not report any treatment or therapy for the symptoms.									Y	11/07/2006	11/08/2006	1		PVT	PVT	MULTI-VITAMINS		No known allergies.  Denies medical conditions.  Follow-up on 18/Dec/2006 - hay fever, hernia, hemorrhoids.	No adverse effect~Influenza (Seasonal) (no brand name)~UN~0.00~In Patient	200603105	1						1	Cough; Injection site pain; Malaise; Pharyngolaryngeal pain; Rhinorrhoea	FLU3~SANOFI PASTEUR~U2285AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~MASS. PUB HLTH BIOL LAB~TD165~UNK~IM~RA~TD ADSORBED (TDVAX)~1	USA		Influenza
0299517	11/14/2007	PA				F	01/09/2007	Initial report received on 16 November 2006, from a health car professional.  A female patient received on 14 November 2006, Fluzone (U2187AA), into the left deltoid (route and dose not reported).  On 15 November 2006, a day post vaccination, the patient experienced injection site redness, induration and itching at the left deltoid, 5 cm diameter, well circumscribed.  No other signs (corrected) and symptoms were reported.  No corrective treatment was reported.  At the time of the report (16 November 2006), the patient had not recovered.  The patient's medical history, other medications, illnesses at the time of vaccination and concomitant vaccinations were unknown.  Follow-up information received on 20 December 2006.  The patient received Fluzone at approximately 3PM.  The next morning, she had discomfort in the left deltoid and on 16 November 2006, she noted a 5 x 5 cm oval shaped area of erythema and swelling at the injection site - described as itchy.  No significant discomfort.  She has had previous flu shots before with no adverse problems. The patient did not have any other vaccinations within 4 weeks of receiving Fluzone, did not have any illness at the time of vaccination and did not have any medical history.  It was reported the patient recovered.				Y					Y	11/14/2006	11/15/2006	1		PVT	UNK			Follow-up information received on 20 December 2006.  She has had previous flu shots before with no adverse problems.		200603143	1						1	Injection site discomfort; Injection site erythema; Injection site induration; Injection site pruritus; Injection site swelling	FLU3~SANOFI PASTEUR~U2187A~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299521	11/14/2007	AR				F	01/16/2007	Initial report received on 01 December 2006 from a health care professional.  Five patients, with unknown medical history, had received a dose of FLUZONE SV '2006-'2007 USP, lot number U2308AA, on an unknown date.  The routes and site of administration were not reported.  Twenty-four to 48 hours post-immunization, all five patients experienced severe headache, nausea, and flushing.  Three of those patients had additional symptoms of chest discomfort, numbness, and tingling.  Per the reporter, none of the patients received relief from the severe headache after taking pain relievers.  None of the patients were identified as to who had what.  Reportedly, none of the patients were medically evaluated.  At the time of this report, the recovery status of the patients was unknown.  Follow-up information was received on 15 January 2007.  The reporter indicated that the obtained the original information for this case from a service person and they are prohibited by privacy laws to divulge any identifying information about the person who reported the events to them.  The reporter does no have access to the medical records that would provide additional information about this case.  This reporter is unable to provide any further information regarding this case.  The reporter for this case is the same as for case 2006-03338.									U					MIL	MIL			It was reported that it was unknown if the patients had any illnesses, pre-existing medical conditions, use of other medications, or had received any other vaccinations within four weeks of the vaccination.		200603337	1						1	Chest discomfort; Flushing; Headache; Hypoaesthesia; Nausea; Paraesthesia	FLU3~SANOFI PASTEUR~U2308AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299522	11/14/2007	FL	47.0	47		F	01/24/2007	Initial report received from a patient (with a history of allergies to latex, SMZ-TMP, Nubain, Darvocet and asthma) developed mild itching on the back, trunk and arms at 0900 after she received an injection of Fluzone (lot number u2195aa) intramuscularly in the right deltoid on 26 October 2006 at 0745.  She had generalized itching by 1100, felt flushed at 1200 and noted her face, neck and ears were very red. The injection site was red and had chills, her neck,face and ears were red and she had generalized rash. From 1600-1900 hours, she was sleeping. At 1900 she had itching and took Benadryl 50 mg. At 2045, she had a low grade fever and at 2300, she had chills and took Benadryl 50 mg and Advair puffs. On 27 October 2006, her rash was gone and itching was gone, however her neck and ears remained red and hot. She did not have any illness at the time of vaccination. It was reported the patient.  Follow-up information received on 23 January 2007 from the patient. A diagnosis was not determined, and no diagnostic testing was performed. There was no illness at the time of vaccination.									Y	10/26/2006	10/26/2006	0		PVT	OTH			Allergies to latex, SMZ-TMP, Nubain, Darvocet. Asthma		200603464	1						1	Chills; Erythema; Flushing; Injection site erythema; Pruritus generalised; Pyrexia; Rash generalised	FLU3~SANOFI PASTEUR~U2195A~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299690	11/14/2007	PA	40.0	40		F	11/07/2006	A 40-year-old female patient had received an intramuscular, left deltoid injection of Fluzone SV 2006-2007, lot number U2195AA, on 04 October 2006. Immediately following administration, she noticed a black dot at the injection site. After several hours, it still had not resolved. The patient provided pictures of the site which demonstrate a small, dark, discoloration on the skin surface. The needle used was a BD Safety Glide, 23 gauge, one inch needle, lot number 611520 CAV03. The reporter indicated that there were 12 other patients (out of 46 administrations) that also experienced a black dot following vaccination. The black dot was present on some of the patients up to a week later. Per the reporter, all kinds of needles were used including BD Safety Glide and BO Integra as well as two other types for which she was not sure of the names. The reporter stated that they, tested drawing up the vaccine and then wiping the needle on an alcohol pad, and the black residue was visible. We ran three of the same needles through the alcohol pad right out of their packages and there was no residue. At the time of this report, recovery status was unknown. Follow-up information received on 03 November 2006 from the patient. Per the reporter, the dot does not resolve until either the skin is removed or over time as the skin is shed. The patient removed the dot by removing the affected skin. The patient recovered from the event.									Y	10/04/2006	10/04/2006	0		UNK	UNK					200602612	1						1	Immediate post-injection reaction; Injection site discolouration	FLU3~SANOFI PASTEUR~U2195a~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299691	11/14/2007	UT				F	11/20/2006	A female patient (date of birth and age not reported) had received a left deltoid, intra-muscular injection of FLUZONE SV 2006-2007 USP, lot number unknown; and a left deltoid, intra-muscular injection of Pneumovax, manufacturer Merck, lot number not reported, on 09 October 2006. Approximately five hours post-immunisation, the patient developed redness and swelling approximately six inches below the arm pit to the elbow. She denied any other symptoms or any local reaction to the actual injection site. The patient required medical evaluation, but the diagnostics and treatments received were not reported. At the time of this report, it was unknown if the patient had recovered from these adverse events. Another patient had the same type of reaction at the same facility that is reported in case 2006-02658. Follow-up information received on 17 November 2006 from a health care professional. As per the reporter, it was determined that it was not the flu shot, but the Pneumovax shot. Further information is not anticipated.				Y					U	10/09/2006	10/09/2006	0		UNK	UNK					200802859	1						1	Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0296304	11/15/2007	GA	73.0	73		M	11/15/2007	HIVES/RASH ON LEFT ARM AND SHOULDER LESS THAN 20 HRS AFTER VACCINE, PAIN AND DISCOMFORT OF AFFECTED AREA. STARTED VALTREX ON 11/3/07 PER DR VALTREX TAKEN 3/DAY FOR 7 DAYS				Y					U	11/01/2007	11/02/2007	1	11/1/07 - ZOSTAVAX VACCINE AT 10:00 AM AND BY NURSE OF DR. ; 11/2/07 - DIAGNOSIS SHINGLES BY DR (ORTHO PEDIC); 11/3/07 STARTED ON VALTREX, DIAGNOSED SHINGLES BY DR (CLINIC); 11/4/07 - RECONFIRMED BY DR.; 11/5/07 - DIAGNOSED SHINGLES BY DR (GP); 11/5/2007 CONFIRMED BY SHINGELS TEST AS SHINGLES BY DR (DERMATOLOGIST)	PVT	UNK		None	PINCHED NERVE 7/8 VERTIBRA CAUSED PAIN IN LEFT ARM			1						2	Rash; Rash vesicular; Discomfort; Herpes zoster; Musculoskeletal pain; Pain in extremity; Rash; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81108~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARZOS~MERCK & CO. INC.~1089U~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|VARZOS~MERCK & CO. INC.~1089U~1~UN~UN~ZOSTER LIVE (ZOSTAVAX)~2	USA	Emergency room visit	Influenza
0296712	11/15/2007	OR	52.0	52		F	11/15/2007	Small cough started @ 2:00 p.m. By 3:30 I was feeling an illness coming on. Checked my temp.  101  and went to 102 by 6:00 p.m.  After taking Ibprofen fever went down to l01.  At l0:00 p.m. I took   Aleve.  Was very achey and had a sore throat all night...eyes very bloodshot and puffy in the morning.  Fever gone too.  Felt pretty normal as day wore on.									Y	11/09/2007	11/09/2007	0	none	UNK	UNK	none	none	none			1						1	Body temperature increased; Cough; Eye swelling; Malaise; Ocular hyperaemia; Pain; Pharyngolaryngeal pain	FLUX~UNKNOWN MANUFACTURER~na~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296792	11/15/2007	MO	51.0	51		F	11/15/2007	Employer offered flu shots to employees.  On 10-26-07 all employees interested had the shot.  Multiple employees have experienced continued aches/pains in the arm of the shot.  Personnally, if I lift my arm over shoulder height, I get a shooting pain in the area of the shot.  It has been almost three weeks. We spoke with two local nurses who said normally you could experience aches/pain in your arm for a couple of days but shouldn't last as long as three weeks.  Since multiple people have experienced the same thing, I can't help but think that maybe there was something wrong with the shot and/or the effectiveness of the shot.									N	10/26/2007	10/26/2007	0		UNK	UNK		None	None	none~ ()~~0.00~In Patient		1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2494AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296793	11/15/2007	WI	38.0	38		F	11/15/2007	Respiratory Reaction. Needed to use inhaler and flonase one hour after getting vaccine because of tightness in throat. Symptoms lasted approximately 3 hours. Patient has history of severe Asthma, along with mutiple allergies.									U	10/28/2007	10/28/2007	0		PUB	UNK			Asthma, Multiple allergies			1						1	Respiratory disorder; Throat tightness	FLU3~SANOFI PASTEUR~U2464AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296794	11/15/2007	MO		35		F	11/15/2007	The shot hurt in an unusually painfull way from when I have ever received the shot in the past. My shoulder hurts so bad to lift my arm is almost impossible. This has been going on for a little over a week now.									N	10/26/2007	10/26/2007	0		UNK	PVT	N/A					1						1	Injected limb mobility decreased; Injection site pain; Musculoskeletal pain	FLUX~UNKNOWN MANUFACTURER~~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296795	11/15/2007	NY	55.0	55		M	11/15/2007	Client received flu vaccine injection at 4:45pm on 11/14/2007.  He awoke at 4:30am on 11/15/2007 feeling nauseous and dizzy.  He had diarrhea.  The symptoms lasted for 90 minutes. He then felt better and returned to bed.									Y	11/14/2007	11/15/2007	1		PUB	UNK	Atenolol, Jenuvia, Lipitor, Prevocid, 'a water pill'	Has been feeling run down and tired because of increased work schedule and lack of sleep.  Only sleeping about 4 hours per night for several days.	Adult Onset Diabetes, Arthritis			1						1	Diarrhoea; Dizziness; Nausea	FLU3~SANOFI PASTEUR~U2473BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296796	11/15/2007	FL	41.0	41		F	11/15/2007	CLIENT CALLED 11/15/07 TO REPORT THAT ONE DAY AFTER INFLUENZA ADMINISTRATION (10/19/07) SHE BEGAN TO ITCH ON BOTH ARMS.  SHE REPORTS THAT SHE HAD TO BUY A CREAM TO CONTROL THE ITCHING.										10/18/2007	10/19/2007	1		PUB	PUB	NONE	NONE	CLIENT NOW STATES THAT COMPANY FOR WHICH SHE WORKS CHANGED LAUNDRY COMPANY USED TO CLEAN UNIFORMS AND THAT SHE AND OTHER STAFF ARE ALL COMPLAINING OF ITCHING.			1						1	Pruritus	FLU3~SANOFI PASTEUR~U2507AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296798	11/15/2007	MO	57.0	57		U	11/15/2007	Can still feel tightness in left shoulder muscle.  For 3 weeks - could not use left arm much due to pain upon use of the arm.  Attempted to work out with 3 lb weights but did not help.									Y	10/26/2007	10/26/2007	0		UNK	UNK						1						1	Muscle tightness; Pain in extremity	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA		Influenza
0296800	11/15/2007	MO	51.0	51		F	11/15/2007	My Left arm at the top where the shot was given has been very painful ever since i received the flu shot. When I raise my left arm a certain way there is sharp pains in my shoulder where the shot was given.When I raise my left arm to put on deodorant there is sharp pains in my shoulder where the shot was given.When I try turning over in bed I have alot of sharp pain in my shoulder. When I try cleaning out the bathtub i cannot use any pressure in my left arm because of the pain. There is a constant aching in my shoulder all the time & there is also a burning feeling.				Y					N	10/26/2007	10/26/2007	0		UNK	UNK						1						1	Injected limb mobility decreased; Musculoskeletal pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2494AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296801	11/15/2007	NC	51.0	51		M	11/15/2007	Dizzy, diahrrea, fainted, fever, cough later, increase continues in symptoms related to hypertension									U	10/25/2007	10/26/2007	1	scheduled	PUB	UNK	blood pressure medication, aspirin, vitamin	hypertension	congenital spine problem, hypertension			1						1	Cough; Diarrhoea; Dizziness; Hypertension; Pyrexia; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296802	11/15/2007	MO	34.0	34		F	11/15/2007	Pain in left upper arm.									N	10/26/2007	10/27/2007	1		UNK	UNK	Skelaxin, Topamax, Propoxy-n/apap, Mobic, Ambien					1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2494AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296803	11/15/2007	MO	14.0	10		F	11/15/2007	Pain in upper left arm.									N	10/26/2007	10/27/2007	1		UNK	UNK						1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2494AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296804	11/15/2007	MO	12.0	12		M	11/15/2007	Pain in left arm.									N	10/26/2007	10/27/2007	1		UNK	UNK						1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2494AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296806	11/15/2007	CA	68.0	68		F	11/15/2007	After injected, patient made the comment that it felt like the shot went into her muscle.  I assured her that that is where it is supposed to go.  Patient states that later that evening her arm began to hurt at the injection site and she applied ice.  She did not notice any inflammation, redness, or warmth.  Patient does not experience pain at rest; pain is with movement only.  She describes the pain at its worst to be 6-7 out of 10 pain scale.  The pain level has remained the same over the past 4 weeks since immunization.  She has not taken any medications for it and has not seen an MD, although she plans to at the beginning of December.  Past history includes whiplash 5 years ago and prior arm muscular pain, but not related to any past vaccinations.									U	10/18/2007	10/18/2007	0	n/a	UNK	PUB	n/a	none reported	Allergic to PCN			1						1	Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA305AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296810	11/15/2007	NE	54.0	54		F	11/15/2007	3 red spot around the shor area, warm & tender. Red rash throughout body,mostly in warm areas; arm pits, waist, buttocks, back.  Other than the rash, I feel good, no itching or respirator issues. Do I need to be aware of anything else?									Y	11/14/2007	11/14/2007	0		UNK	UNK	toprol, lotrel, thyroid & water pill	none	spring allergies, high blood pressure, thyroid disorder			1						1	Injection site erythema; Injection site pain; Injection site warmth; Rash erythematous	FLUX~UNKNOWN MANUFACTURER~000~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296811	11/15/2007	TX	63.0	63		M	11/15/2007	63yo male who received his flu shot on October 4 at an oustide facility.  On October 15 (six days prior to hospital admission), he started noticing weakness in his toes bilaterally which gradually progressed up to his legs, hips and arms. Patient was unable to crawl or ambulate. Symptoms associated with numbness and tingling to both feet and hands, diplopia and some dysarthia are consistent with demyelinating polyneuropathy (Guillain Barre Syndrome).  Patient admitted to Hospital.  Labs showed elevated protein and patient underwent plasmapheresis for 5 days. Patient is still hospitalized and degree of permenant disability or recovery status is unknown.  1/15/08 Reviewed hospital & rehab medical records which reveal patient experienced numbness & weakness in bilateral toes 6 days prior to admit which gradually progressed up legs to the point where he could only crawl, could not lift legs or arms, had double vision.  Also had congestion, SOB, cough, asthma, wheezing.  Neuro exam was areflexic, muscle weakness shoulders down, decreased sensation in glove & stocking distribution.  Admitted to intensive care 10/21-11/6/2007.  Neuro, Pulm, ST/OT/PT consults done.  LP done.  Tx w/plasmapheresis x 5 days via right femoral Quinton cath w/only slight improvement.  Transferred to inpatient rehab from 11/6-12/20/2007.  Improved to be able to ambulate w/rolling walker for short distances w/assist.  D/C to home for outpatient PT/OT, neuro & pcp f/u. FINAL DX: Guillain Barre syndrome, quadriparesis, HTN, COPD, asthma, UTI. Per 60 day follow up: Currently undergoing physical therapy, left hospital with residual effects from GUILLAIN BARRE.				Y	Y	26	Y		Y	10/04/2007	10/15/2007	11	Protein CSF = 63 (10/21/2007); D-Dimer = 1.1 (10/21/2007) LABS: WBC 9.6 (N), Na 135.  CT head WNL.  Urine (+) ketones & (+) opiates.  EKG showed RBBB.  EMG/NCS c/w severe GBS.	UNK	UNK	Diovan, tramadol, omeprazole, proventil/atrovent, ASA 81mg, Niacin OTC		COPD, Asthma, HTN, MI (s/p PTCA) PMH: home O2 dependent,  MI w/PTCA & stents.  quit smoking 4 yrs ago.			1						1	Abasia; CSF protein increased; Demyelinating polyneuropathy; Diplopia; Dysarthria; Electrocardiogram abnormal; Fibrin D dimer; Fibrin D dimer decreased; Guillain-Barre syndrome; Hypoaesthesia; Hypokinesia; Muscular weakness; Paraesthesia; Plasmapheresis; White blood cell count normal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79718~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0296812	11/15/2007	NE	8.0	8		U	11/15/2007	Fever to 102.6 with chills and vomiting developed 12 hours after vaccine was given.  She was evaluated 6 hours after the onset of symptoms. She received one dose of tylenol Her exam revealed 3+ red tonsils and generalized abdominal tenderness.  Her  temp was 98.2 and patient stated she was hungry for Burger King.				Y					Y	11/14/2007	11/15/2007	1	Rapid Strep was negative	PVT	PVT	Claritan 10 mg prn and tylenol x 1 dose	Pt had experience a mild cough for 1 week prior to the vaccination.	Allergic Rhinitis			1						1	Abdominal tenderness; Chills; Pyrexia; Streptococcal identification test; Tonsillar disorder; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500497P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0296813	11/15/2007	CA	50.0	50		M	11/15/2007	Day 1: Headache, dry throat. Day 2: Headache, sneezing, body ache, nausea, fever, dizzyness. Day 3: Headache, cough, body ache, nausea, fever, dizzyness.  Day 4: Headache, dizzyness, nausea.  Treated with asperin.									Y	11/09/2007	11/11/2007	2	None.  Probably flu.	UNK	UNK	None	None	None			1						1	Cough; Dizziness; Dry throat; Headache; Nausea; Pain; Pyrexia; Sneezing	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296814	11/15/2007	CA	26.0	26		M	11/15/2007	flu vaccine administered in left deltoid at 0954 and at 0955 became light headed and sat down.  At 10:05a client was in and out of conciousness and had a petite mal seizure lasting approx. 30 seconds in duration (paramedics on site).  Was transported to Hospital				Y					U	11/13/2007	11/13/2007	0	none at present time; still trying to contact the client for a follow up.	UNK	UNK	none (per client)	Client stated he had a seizure at 20 years old.	unknown			1						1	Convulsion; Dizziness; Loss of consciousness; Petit mal epilepsy	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA054AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0296815	11/15/2007	VA	5.0	5		F	11/15/2007	nosebleed on 11/7/07 after receiving FluMist.  Bled approximately 10 min from right nostril.  moderate amount of bleeding.									Y	11/07/2007	11/07/2007	0	none known	PUB	PUB		none known	none known		VA07:025	1						1	Epistaxis	FLUN3~MEDIMMUNE VACCINES, INC.~500492P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0296816	11/15/2007	VA	58.0	58		F	11/15/2007	According to patient she has been menopausal for 2-3 years and the day after she received the influenza vaccine she had clear vaginal discharge (patient referred to it as if she was ovulating).  Later in the month she experienced breast tenderness and on 11/13 she started her period again after 2-3 years.  She also expressed concern that she had left leg numbness (back of leg) that began on 11/11/07.  She thinks this is related to previous neck injuries and surgeries, however she has never had the back of her leg hurt.  According to the patient she has not started any new medication (including OTC, herbal or dietary supplements)									U	10/22/2007	10/23/2007	1	patient will f/u with MD this week.	UNK	UNK	patient did not disclose	no	patient did not disclose			1						1	Breast tenderness; Hypoaesthesia; Menopause; Menstrual disorder; Vaginal discharge	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80070~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0296817	11/15/2007	CA	87.0	87		M	11/15/2007	Stomach ache, fever 100.8 degrees, Many muscles aching. Duration about 48 hours.									Y	11/13/2007	11/13/2007	0	None	UNK	UNK	ZOCOR, WARFRIN,DIGITEX,ALLOPURINOL,LYCRIA	None	None	None~ ()~NULL~~In Patient|None~ ()~NULL~~In Sibling1		1						1	Abdominal pain upper; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296818	11/15/2007	MI	32.0	32		F	11/15/2007	8.45 am Flu vaccine given.10.20 am client felt hot, upset stomach,nausea and diarrhea. 10.45 skin itchy.To Urgent Care Clinic. Apparent testing and notified she was allergic to chicken feathers. Given benadryl and Cortisone plus 3 day supply of same. Told by physician not to have flu shot again.				Y					U	11/08/2007	11/08/2007	0		UNK	UNK		per client none	allergy to Codeine			1						1	Allergy to animal; Diarrhoea; Feeling hot; Nausea; Pruritus; Stomach discomfort	FLU3~SANOFI PASTEUR~U2507AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296819	11/15/2007	SD	86.0	86		F	11/15/2007	11-14-07 0845 Client called and stated that her arm was still sore from when she received the flu shot.  She received the flu shot on 11-01-07 0905 Novartis Lot #80073 in left deltoid IM.  She noted there was no pain when she received the flu shot.  There is no redness or swelling present.  She has noticed no lumps or bumps in the area where she received the shot.  It is just sore and achy from her shoulder to her elbow on the left side.  She stated 'its just lame especially when I try and pull jeans up or pull a sweater over my head.'  She feels it doesn't bother her as much during the day as it does at night.  She does have arthritis in her hands and a spur in her neck.  She takes Vicodin daily for that and feels that may be why her arm doesn't hurt as much during the day.  She is seeing a Dr. on 11-16-07 for another reason and will visit with her about her arm.  She will notify me if there are any changes.									Y	11/01/2007	11/03/2007	2		UNK	UNK	Potassium, Hydrocodone, Aspirin, Heartburn relief 75, Lasix, Coumadin, Citalopram	None	Arthritis in hands and spur in neck, depression, polycythemia			1						1	Myalgia; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80073~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0296820	11/15/2007	MI	7.0	7		F	11/15/2007	LOCALIZED REACTION ON RIGHT THIGH 7X7 CM LARGER ON DAY 2 THAN DAY ONE POST INJECTION TREATED WITH ZYRTEC 10 MG PO DAILY FOR A WEEK									N	11/13/2007	11/15/2007	2		PVT	PVT	LANTUS, NOVOLOG	TYPE 1 DM	ALLERGIC TO CINNAMON			1						1	Injection site reaction; Local reaction	FLU3~SANOFI PASTEUR~U2502AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0200U~1~IM~RL~PNEUMO (PNEUMOVAX)~1|VARCEL~MERCK & CO. INC.~1343U~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0296843	11/15/2007		70.0			F	11/15/2007	This case was reported by a physician to a vaccine distributor and described the occurrence of fever in a 70-year-old female subject who was vaccinated with (Flulaval, GlaxoSmithKline) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. Information regarding previous immunization with influenza virus vaccine was not provided. On 8 November 2007 the subject received unspecified dose of Flulaval (unknown). On 9 November 2007, 1 day after vaccination with Flulaval, the subject called the physician and reported that she experienced a fever and flu-like symptoms. The subject had to be hospitalized. The physician doesn't know if the subject has viral encephalitis or if she has meningitis. The subject is undergoing magnetic resonance imaging for the lumbar spine. The physician reported on 14 November 2007 that the subject is now in a near comatose state. At the time of reporting the fever and flu-like symptoms were worse.					Y	0			U	11/08/2007	11/09/2007	1	UNK	OTH	OTH		Unknown	The subject's medical history, concurrent conditions, and concurrent medications were not reported. The vaccine distributor reported that one other subject experienced an adverse event following receipt of Flulaval. Please see case A0694812A.		A0694802A	1						1	Coma; Influenza like illness; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA032AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation	Influenza
0296845	11/15/2007	OK	52.0	52		M	11/15/2007	This case was reported by a consumer and described the occurrence of pain in a 52-year-old male subject who was vaccinated with (Fluarix, GlaxoSmithKline) for prophylaxis. The reporter is the wife of the subject. A physician or other health care professional has not verified this report. The subject's medical history included asthma and disc herniation. Concurrent medications included Fluticasone propionate+salmeterol xinafoate (Advair), Salbutamol sulphate (Albuterol) and Naproxen. The subject had received influenza virus vaccine in previous years and experienced minor soreness at injection site. The subject had no adverse events following receipt of any other type of immunizations. On 17 October 2007 at 1:12 p.m., the subject received unspecified dose of Fluarix. The consumer reported that the subject inadvertently received this dose of Fluarix in the joint space of the shoulder instead of the deltoid. As a result of this inadvertent administration into the joint space of the shoulder, the subject experienced drug administered at inappropriate site. The consumer reported on 09 November 2007, that the initial reaction was severe pain followed by barely being able to move the arm. The reporter also noted that the subject Was initially put on light duty at work. The date of onset of these adverse events was not reported. The subject was seen at a physician's office. The consumer considered the events to be disabling and to jeopardize the subject or require intervention. At the time of reporting the pain and difficulty moving the arm were unresolved.				Y				Y	N	10/17/2007			UNK	PUB	OTH	Fluticasone+salmeterol; Salbutamol sulphate; Naproxen	Unknown	Asthma; Disc Herniation		A0694604A	1						1	Drug administered at inappropriate site; Injected limb mobility decreased; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA307DA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Disabling	Influenza
0296846	11/15/2007	GA	88.0			F	11/15/2007	This case was reported by a pharmacist and described the occurrence of paralysis in a 88-year-old female subject who was vaccinated with (Fluarix, GlaxoSmithKline) for prophylaxis. On 8 November 2007, in the afternoon, the subject received unspecified dose of Fluarix at 0.5 ml in the right arm. In the morning, on 9 November 2007 the subject experienced lower extremity paralysis and numbness and tingling in her arms. The subject was seen by her local clinic physician and received no treatment. She was admitted to the hospital on 10 November 2007. The pharmacist considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The pharmacist considered the events were probably related to vaccination with Fluarix.					Y	0		Y	N	11/08/2007	11/09/2007	1	UNK	OTH	PVT		Unknown	The subject's has previously received flu shots. Several years ago after receiving the flu shot the subject's arm went numb.		A0694598A	1						1	Diplegia; Hypoaesthesia; Paraesthesia; Paralysis; Vaccine positive rechallenge	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA296JA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation,Disabling	Influenza
0296848	11/15/2007	WA				U	11/15/2007	This case was reported by a healthcare professional and described the occurrence of incorrect storage of drug in a subject of unspecified age and gender who was vaccinated with (Flulaval, GlaxoSmithKline) for prophylaxis. The healthcare professional reported that multiple subjects (number unknown) were given Flulaval that was improperly stored, however, a specific number of subjects was not reported. The subject received no other immunizations on the date of receipt of Flulaval. In October 2007 the subject received unspecified dose of Flulaval (unknown) that had been stored incorrectly. The healthcare professional reported that according to the temperature log, on three separate occasions from 21 October 2007 to 24 October 2007, the temperature in the vaccine refrigerator got down to 33 degrees Fahrenheit. The healthcare professional considered the event was clinically significant (or requiring intervention) and could be jeoparding to the subjects. No clinical events were reported.									U	10/01/2007	10/01/2007	0	UNK	PVT	PVT		Unknown	The healthcare professional also reported that an unspecified number of subjects received Boostrix that had been stored incorrectly. Please see case A0694577A.		A0694566A	1						1	Medication error; Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA075AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0296849	11/15/2007	PA	87.0	87		M	11/08/2007	Patient given Flu vaccine + Pneumovax vaccine on 10/15/07 and developed general weakness/malaise and a rash/ shingles 10/17/07. 12/28/07 Reviewed hospital medical records which reveal patient experienced vomiting & weakness.  Seen by pcp 3 days s/p vax & dx w/mild immunization reaction.  5 days later, had lightheadedness, syncopal episode, fall & head injury.  Returned to pcp for weakness & difficulty voiding.  Admitted 10/25-12/11/2007.  Neuro, urology, GI, Ortho,Ophthal consults done.  TX w/antibiotics & antifungal for asp pneumonia & UTI.  Received TPN x 2 wks & PEG tube placed.  Nectoric areas of left great toe & left heel debrided.  Improved minimally & was transferred to rehab unit at d/c.  It was felt his mental status changes were possibly a result of post concussive syndrome & mild encephalitis from herpes zoster. FINAL DX: syncopal episode w/prolonged altered mental status, etiology unclear.				Y	Y				Y	10/15/2007	10/18/2007	3	LABS: CT of head revealed old left thalamic infarct.  Video swallowing study revealed aspiration.  Carotid US revealed mild plaque formation.  Abdominal CT scan revealed .  Arterial doppler of LEs revealed proximal aortic iliac disease, occlusion at distal superficial femoral artery & thrombosed popliteal aneurysm.  Thyroid scan WNL.  MRI of brain c/w chronic small vessel disease.  CXR parenchymal infiltrates.  Blood c/s neg.  Urine c/s (+) for candida albicans.  GI endoscopy revealed distal esophageal stricture which was dilated.	PVT	UNK		None noted	allergy to ZOCAR and COUMADIN PMH: CAD, ischemic heart disease s/p MI of unkown date, HTN, dyslipidemia, impaired glucose tolerance, chronic kidney disease stage III, protein C deficiency, spinal stenosis, macular degeneration, CVA, CABG, repair of AAA, PVD, dysphagia w/aspiration syndrome, pneumonia, UTI, congnitive impairment s/p head injury, ischemic foot ulcers, vit D deficiency, righ BKA, recent herpes zoster of scalp.			1						1	Asthenia; Herpes zoster; Malaise; Rash	FLU3~SANOFI PASTEUR~U2448AA~6~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~7+~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0296850	11/15/2007	LA	82.0	82		F	11/09/2007	Patient c/o severe pain to right arm after receiving Pneumovax vaccine went to ER - was kept overnight -.  11/30/07 Reviewed hospital medical records which reveal patient experienced severe right shoulder pain, dizzy & near syncope beginning 11/1/07.  Admitted 11/2/2007 overnight only.  Exam revealed marked swelling of deltoid. FINAL DX: severe drug reaction to pneumonia vaccine, reactive inflammatory response of deltoid.				Y	Y	1			Y	11/01/2007	11/01/2007	0	LABS: WBC 14.16 (H), neutros 82.3% (H), lymphs 7.7% (L).  Right shoulder x-ray revealed OA.  CXR WNL.	PVT	PVT	Vytorin, Nexium, ASA, MVI, Vit E, Allegra, Boniva, Mucinex, fish oil, Benicar, Tylenol, Flex A min-Glucosamine and Chondroitin, Ginko Biloba, folic acid	None	Tetanus, Sulfa, Prevacid, Toprol, Mascof PMH: allergic sulfa & tetanus.  ASHD, HTN, dyslipidemia, CABG w/stents			1						1	Pain in extremity	FLU3~SANOFI PASTEUR~42528AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0061U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0296852	11/15/2007	LA	4.0	4		M	10/25/2007	10/24 Presented to MD with fever, chills, headache and lower extremities pain, sore throat. Treated as viral gave Motrin. 10/25 symptoms worse patient admitted to hospital.  11/30/07 Reviewed hospital medical records which reveal patient experienced fever & HA x 2 days.  Exam revealed erythemic posterior pharynx.  Admitted 10/25-10/27/2007.  Tx w/IV antibiotics & decongestants.  Symptoms resolved, labs returned to normal & d/c to home on continued oral antibiotics & decongestant. FINAL DX: Fever of unknown origin.				Y	Y	3			Y	10/22/2007	10/23/2007	1	CBC on 10/24 LABS: Rapid strep & mono tests neg.  WBC 26 (H).  UA WNL.  CXR showed mild bilateral peribronchial thickening.  Blood cultures neg.	PVT	PUB	None	None	None			1						1	Chills; Full blood count; Headache; Pain in extremity; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U2487AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1178U~2~SC~LL~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0296856	11/15/2007	MN	33.0	33		F	11/08/2007	Presented with itching at injections site. within 15 minutes at injection. Within 30 minutes of injection had difficulty breathing. Given Epi injection via Epi-pen x 3 doses within 15 minutes, Solumedrol 125mg IM, transported to Emergency Department.11/26/07-records received for DOS 11/6/07-seen in ED for C/O fullness in throat, itching, throat felt tight. DX-Acute allergic reaction resolved.			Y	Y					Y	11/06/2007	11/06/2007	0		PVT	PVT	Unknown	None	Allergies - Codeine; Lactose Intolerance; Dilaudid; Cats			1						1	Dyspnoea; Injection site pruritus; Dyspnoea; Injection site erythema; Injection site pruritus; Pharyngeal oedema	FLU3~SANOFI PASTEUR~U2487AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2487AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening	Influenza
0296857	11/15/2007	IL	70.0	70		F	11/07/2007	Sore throat, itchy eyes, face tingling 10 minutes after injection. Treated at facility with Albuterol nebulizer, Solumedrol 125mg IM, Medrol dose pack; started on Allegra. 9:00pm - swelling in face, tingling went to ER - developed palpitations - short of breath - in atrial fibrillation with rapid ventricular response. Treated w/ Cardizem and converted to NSR. Admitted to hospital for overnight observation. No known history of atrial fibrillation. Started Cardizem 120mg; ASA 325mg. 11/26/07-records received for DOS 10/31-11/01/07-DC DX: New onset atrial fibrillation with rapid ventricular response. Possible brough on by stress of allergic reaction. Hypertension, controlled. Allergic reaction secondary to influenza vaccine. After receiving vaccine C/O throat sore, mouth felt swollen, tingling around lips. Palpitations shortness of breath.			Y	Y	Y	1			Y	10/31/2007	10/31/2007	0	CXR; EKG; 2 D ECHOCARIDIOGRAM; CHEM PANEL; TROPONIN LEVEL; CBC; CK; BNP 11/26/07-records received-D-dimer slight elevated. Glucose elevated to 277. Troponin 0. EKG atrial fibrillation with RVR. Echocardiogram atrial fibrillation. Left ventricular hypertrophy. Aortic valve sclerosis.	PVT	PVT	LISINOPRIL; HCTZ; LOVASTATIN; SYNTHROID	None Known	Allergies: Contrast dye; Penicillin; Cefazolinil Diagnosis: Hypertension; Hyperlipidemia; Asthma; diet - controlled diabetes; Osteoarthritis; Hypothyroidism 11/26/07-records received-PMH: hypertension, hyperlipidemia, hypothyroidism. Diabetes type 2 controlled. Osteoarthritis. HX of reaction to penicillin.			1						1	Atrial fibrillation; Blood creatine phosphokinase; Brain natriuretic peptide; Chest X-ray; Dyspnoea; Electrocardiogram; Eye irritation; Eye pruritus; Full blood count; Laboratory test; Palpitations; Pharyngolaryngeal pain; Swelling face; Troponin	FLU3~SANOFI PASTEUR~U2502AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0296858	11/15/2007	MS	44.0	44		F	11/05/2007	About 6:30 pm on 10/24/07 I was feeling bad pain and body aches and fever on my left arm and through my body on 10/25. I was feeling worse and found red fever, swollen at injection site. I ran 102 degree fever, short of breath, aches, pain. 10/27 pain bad I went to doctor  said staff and prescribed Bactrim, pain med and inhaler. I still have purple mark on arm.  11/16/07 Received verbal report of lot #'s from Health Department: flu U2445AA and pneumo 0858U.  Database updated.  11/26/07 Reviewed medical record from clinic dated 10/25/07.  Reveals injection site left arm red, swollen & painful.  Patient also had chest heaviness. Tx w/oral antibiotic, inhaler & pain med. 2/12/08 Reviewed pcp medical records whichreveal patient initially seen 11/8/07.  left arm flu shot site red & swollen.  To continue antibiotic.  Next vs 11/28 left arm still mildly red & swollen but much improved. FINAL DX: cellulitis left arm.			Y	Y					Y	10/24/2007	10/24/2007	0	Staph at injection sites LABS: CBC, chemistry WNL. Cholesterol & triglycerides (H).	PUB	PUB		None	Asthma PMH: bipolar disease, asthma.  Allergic: codiene, erythromycin.			1						1	Dyspnoea; Injection site erythema; Injection site swelling; Injection site warmth; Pain; Pyrexia; Staphylococcal infection	FLU3~SANOFI PASTEUR~U2445AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0858U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening	Influenza
0296862	11/15/2007	AL	36.0	36		F	11/02/2007	Influenza shot given 10/05, a viral process with bronchitis starting 10/05 & continuing till 10/14, when a gastrointestinal process started. This continued until admitted to Stringfellow Hospital by Dr. PT evaluated when admitted 10/27/07 for c/o ascending numbness in feet by Dr. Given Immunoglobulin x5 days after + Spinal Tap for protein. Not at present--still has numbness in feet. 11/26/07-records received for DOS 10/21-10/26/07 DC DX: Guillain-Barre syndrome, status post intravenous IgG therapy. Presented to ED with C/O right lower extremity and right upper extremity numbness associated with facial numbness that started distally and was progressing centrally. Per 60 day follow up: Still have residual weakness and numbness in right leg.					Y	5			N	10/05/2007	10/14/2007	9	Spinal Tap 10-21-2007. records received 11/26/07-CBC WNL, Chemistry WNL. Carotid doppler and 2D echo unremarkable. Stool culture negatvie. Occult blood stool positive. EEG unremarkable. CT head normal. MRI brain unremarkable. Westergren sed rate elevated.  Lumbar puncture CSF showed no WBCs, no RBCs but positive increased protein.	UNK	UNK	Diovan HCT, Asmanex, Singulair, Cardizem	Denies records received 11/26/07-One week prior had nausea vomiting and diarrhea which is almost completely resolved.	Hypertension, Diabetes, Asthma, High Cholesterol records received 11/26/07-diabetes mellitus type 2. hyperlipidemia. asthma.			1						1	Blood product transfusion; Bronchitis; Gastrointestinal disorder; Hypoaesthesia; Hypoaesthesia; Lumbar puncture; Muscular weakness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA282DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0296864	11/15/2007	IN	48.0	48		F	11/15/2007	Received flu shot 10/25/07 about 1 p.m.-1:30 p.m.  Rash began on lower extremities at approximately 7 p.m. ( 6 hours later), rash continued to spread to trunk, upper extremities by next morning.  Client did experience uticaria, but did not report any other s/s.  Visited ER 10/27/07 and started on oral steroids with diminishing dose schedule to be administered over several days (Medrol pack).  Follow up visit with primary MD,following week, rash almost resolved.  Client did state she had received influenza vaccine for the past few years without adverse response.				Y					Y	10/25/2007	10/25/2007	0	None noted	PUB	PVT	Lisenapril- 2, 20 mg tabs dly; Pepcid 20 mg 1 dly, Diltazem 60 mg, 1 tab bid, Xanax prn	None reported or indicated on influenza screening questionnaire prior to immunization.	Allergy: Loratab                                MD documented medical problems:  GERD, migraines, depression, osteoarthritis, hypertension and borderline hyperglycemia per MD office			1						1	No reaction on previous exposure to drug; Rash; Urticaria	FLU3~SANOFI PASTEUR~U2452AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296865	11/15/2007	NM	5.0	5		M	11/15/2007	One week after shots given, multiple (>50) red, round, pruritic plaques ranging from 1 cm - 6 cm some w/ central clearing on trunk, neck, arms, legs, groin, sparing palms/soles errupted.  No other history of URI symtpoms nor allergenic exposure given.  Treated with triaminolone 0.1% ointment and hydroxyzine 12.5 mg q 6 hours started the day form completed.  Lesions look like hives vs. erythema multiforme.									U	11/08/2007	11/15/2007	7	None	PVT	PUB	None	No signs of respiratory infection.	Speech delay			1						1	Erythema; Erythema multiforme; Pruritus; Rash; Skin lesion; Urticaria	DTAP~SANOFI PASTEUR~C2650AA~4~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~42476JA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~08014~2~IM~LA~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~Z0872~4~SC~LA~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~1232F~2~IM~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0296866	11/15/2007	MI	41.0			F	11/15/2007	Received a TIV one month previous to 11-10-07.  Presented at Health Center 11-10-07 and saw CFNP. Pt c/o of severe pain in left arm, from left side of neck to left elbow, which awakens her at night. Pt is taking Tylenol for pain control, but took Vicoden 11-9-07. On exam, left bicep tenderness, subacromium bursa tenderness, and deltoid muscle tenderness, full range of motion, normal stabitlity, strength and tone.  No skin discoloration or edema.  Naprosyn 500mg, 1 BID.									U				NOne	UNK	UNK	Vitamin C, multivitamins, Hydroxyzine 25mg TID, Calcium 500 daily.					1						1	Musculoskeletal pain; Myalgia; Neck pain; Pain in extremity; Sleep disorder; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296871	11/15/2007	IA	32.0	32		F	11/15/2007	Pain in L deltoid (administration site), arm weakness and increased pain when lifting over head, tingling in fingers of left hand in AM which resolves approx 15 minutes after awakening									U	10/22/2007	10/22/2007	0	None	PUB	PVT	multivitamin daily	none	none			1						1	Injection site pain; Muscular weakness; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA315AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296872	11/15/2007	MO	59.0	59		F	11/15/2007	Flu shot was provided by my employer and given at the Sheriff's Department.  A couple hours after getting flu shot, my upper arm hurt and felt warm in the area of the shot. My upper arm was extremely sore and achy for almost 2 weeks.  My upper arm still hurts and feels warm but to a much lesser degree. I have never had a reaction with previous flu shots.									N	10/26/2007	10/26/2007	0	none	UNK	UNK	None	None	Sinus			1						1	Injection site pain; Injection site warmth; Myalgia; No reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~U2494AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296874	11/15/2007	IA	55.0	55		F	11/15/2007	Severe pain in right deltoid ever since receiving flu shot over three weeks ago.  Cannot sleep at night because of the pain. Increased pain when lifting over head.				Y					U	10/22/2007	10/23/2007	1	None	PUB	PVT	Coreg 25  mg. b.i.d.; Aspirin one a day; Calcium; Multivitamin; Glucosamine Chondroitin	None	Cardiomegaly			1						1	Pain in extremity; Sleep disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA 315AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296875	11/15/2007	AL	6.0	6		F	10/18/2007	10/18/07, Mom described as red & swollen area 3-4 on arm site. Mom called doctor and was told it was a normal reaction. Spoke with Mom on 10/19/07 and she stated daughter was fine and there was no longer any redness or swelling. No medical care sought.									Y	10/15/2007				PUB	PUB	None	None				1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2487AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296876	11/15/2007	AL	6.0	6		M	10/22/2007	Mother described reaction as a local reaction to arm after vaccination--did not develop fever--did not seek medical care.									Y	10/15/2007				PUB	UNK		None				1						1	Local reaction	FLU3~SANOFI PASTEUR~U2487AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296877	11/15/2007	PA	55.0	55		F	11/15/2007	10 days post injection, 3/4 inch by 1/2 inch bullae formed at injection site with surrounding erythema.									U	11/05/2007	11/15/2007	10		PVT	PVT	advair;lisinopril/hctz;asa162mg/day;multivitamin	no	asthma;htn			1						1	Blister; Injection site erythema; Injection site reaction	FLU3~SANOFI PASTEUR~c2678aa~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296878	11/15/2007	IL	67.0	67		F	11/15/2007	PT STATES APPROX 1 HR AFTER RECEIVING VACCINATION, SHE EXPERIENCED PAIN IN UPPER LT ARM THAT, WITHIN THE NEXT FEW HOURS, WENT UP THE BACK OF HER NECK AND THEN INTO HER RT ARM.  SAYS RT ARM WAS MORE UNCOMFORTABLE THAN LT.  STATES RT SIDE AND RT LOWER BACK ALSO UNCOMFORTABLE THAT NIGHT, SIMILAR TO DISCOMFORT SHE EXPERIENCED LAST YEAR WHICH SHE BLAMES ON EATING E. COLI TAINTED PEANUT BUTTER (NO MEDICAL TX SOUGHT OR OFFICIAL DX OF E. COLI).  C/O ACHINESS ALL OVER.  DENIES FEVER, WEAKNESS, OR LOSS OF SENSATION.  ALL S/S SUBSIDED IN LESS THAN 24 HOURS.  NO MEDICAL TX SOUGHT.  REPORTS SHE HAS GOT FLU SHOT ANNUALLY X SEVERAL YEARS WITHOUT REACTION.  SAYS SHE DID NOT EVEN FEEL THE SHOT WHEN NURSE ADMINISTERED IT.									Y	11/14/2007	11/14/2007	0		PUB	PVT	FLOVENT, ONCE DAILY	C/O SLIGHT SINUS AND CHEST CONGESTION; RECENTLY HAD A COLD; STATES HAS HX OF RESPIRATORY PROBLEMS, ASTHMA?				1						1	Back pain; Neck pain; No reaction on previous exposure to drug; Pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2509AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296879	11/15/2007	CO	58.0	58		F	11/15/2007	In the night post recieving Fluarix vaccine c/o severe bilateral calves cramping 2 hours. Resolved by morning.									Y	11/02/2007	11/03/2007	1		UNK	PVT						1						1	Muscle spasms	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA315AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296881	11/15/2007	CT	39.0	39		M	11/15/2007	mild soreness at vaccination site (Right deltoid, note form says Left Deltoid).  2 days later, developed closing of throat sensation, followed by Laryngitis same day.  Next day, voice was all but gone, and coughing up yellow mucus.									U	11/12/2007	11/14/2007	2	Vaccine MFR 65K, Lot AFZZAO87AA	UNK	UNK	None	None	None			1						1	Cough; Injection site pain; Laryngitis; Productive cough; Throat tightness	FLUX~UNKNOWN MANUFACTURER~AFZZAO87AA~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296882	11/15/2007	CA	46.0	46		M	11/15/2007	Patient received flu shot on October 4, 2007 @ 3pm.  That night some red spots apeared on upper rt. shoulder.  By Saturday, October 6 red spots appeared on torso, arms, back, legs and most of body.  Spots were mildly itchy and slightly sensitive.  Patient's immunologist said it appears to be an allergic reaction and was treated with antihistamines. Symptoms stabilized by Tuesday October 9.  No further complaints and rash is completely gone.									Y	10/04/2007	10/04/2007	0	N/A	UNK	PVT	UNKNOWN	UNKNOWN	NONE INDICATED BY PATIENT			1						1	Hypersensitivity; Rash erythematous; Rash pruritic	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA303AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296886	11/15/2007	OR	58.0	58		F	11/07/2007	Arm (upper) turned bright red (right arm) painful to the touch lasted about 72 hrs. Took ibuprofen and Benadryl.									Y	11/01/2007	11/01/2007	0		PVT	PVT		No	No			1						1	Erythema; Pain in extremity	FLU3~SANOFI PASTEUR~U2515AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0963U~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296887	11/15/2007		14.0	14		M	11/08/2007	Had syncopal episode lasting about 30 seconds, a few minutes after receiving 3 vaccines Tdap, Menactra and Flu shot.									Y	10/27/2007	10/27/2007	0	None	PVT	PVT	Singulair, Erythromycin	None	Reactive airway disease, Allergic rhinitis			1						1	Syncope	FLU3~SANOFI PASTEUR~U2462AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2484AA~UNK~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2844AA~UNK~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0296889	11/15/2007	MA	26.0	26		F	11/06/2007	Flu vaccine administered about 2 PM. About 230 PM, began to have an allergic reaction (hives). Sent to ER.				Y					Y	11/01/2007	11/01/2007	0	Allergic Reaction	OTH	PVT	Thyroid meds, Asthma med PRN	None	Asthma, Hypothyroid			1						1	Hypersensitivity; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA280DA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296890	11/15/2007	AL	56.0	56		M	11/06/2007	Patient received a Flumist vaccine at age 56. No signs or symptoms of any reaction.									Y	11/03/2007			None	OTH	MIL	N/A	None	None			1						1	Medication error; Wrong drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500484P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0296892	11/15/2007	NJ	41.0	41		F	11/06/2007	Hives on torso, arms and legs, not on face. Benadryl 25mg taken with relief - full recovery next day.									Y	10/15/2007	10/15/2007	0	None	OTH	PVT	None		Asthma, seasonal allergies, allergies to cats and dust.			1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79716~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0296894	11/15/2007	ME	5.0	5		M	11/01/2007	Had immunizations on 10/30/07. Since then has had warmth, redness, tenderness at injection site Lt arm. Treatment - Keflex 250mg/5ml - 10ml TID x 7 d.									U	10/30/2007	10/30/2007	0	N/A	PVT	PUB	Fluoride	N/A	N/A			1						1	Injection site erythema; Injection site pain; Injection site warmth	DTAP~SANOFI PASTEUR~C2607AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2490AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0170~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1180F~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0296895	11/15/2007	KS	33.0	33		F	10/12/2007	Lightheaded, dizzy, hot flashes. Patient stayed in the store about 30 minutes. Her mother was driving her home and patient was not doing anything later in the day. Gave patient 50 mg of liquid Benadryl. Follow-up the next day, patient is doing fine, per mother.									Y	10/11/2007	10/11/2007	0		OTH	PVT	Lexapro, Clonazepam, Cyclobrazeprine, Trazadone, Remeron	None				1						1	Dizziness; Hot flush	FLU3~SANOFI PASTEUR~U2466AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296896	11/15/2007	FL	35.0	35		F		Fever, sore throat, coughing, cannot sleep well. I ache everywhere.									U	11/01/2007	11/02/2007	1	None	OTH	PVT	None	None	None			1						1	Cough; Pain; Pharyngolaryngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296898	11/15/2007	WI	36.0	36		F	10/19/2007	Wheeze, dry cough, slight stuffy nose, itchy throat, started to start at around 9:00 PM. Able to sleep through the night did not take any medications. 10-22-07 PC to client. Did not see HCP. Nasal congestion and itchy throat continued throughout weekend. Also allergic to cats, sulfa, shellfish and environmental allergies. Reports symptoms similar to cat allergies. Reports call to HCP - the RN feel not related to imm. No exposure to known allergens.									Y	10/18/2007	10/18/2007	0	None	PUB	PUB		None	Allergic to cats, sulfa, shellfish and environmental			1						1	Cough; Nasal congestion; Sleep disorder; Throat irritation; Wheezing	FLU3~SANOFI PASTEUR~U2490AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296902	11/15/2007	TX	18.0	18		F	11/06/2007	Pt was given immunizations at 730 (HPV #01 and Flu). Had no c/o adv. sxs; able to walk; conversed with nurse and mother. About 3-5 minutes after shots, patient lost consciousness and fell, face-first, onto (cement) floor in clinic hallway. Had seizure lasting 15-20 seconds. EMS called. Pt transported to hosp. by ambulance.				Y					Y	11/05/2007	11/05/2007	0		PUB	OTH	None listed	None reported	None Reported			1						1	Convulsion; Fall; Immediate post-injection reaction; Loss of consciousness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80959~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HPV4~MERCK & CO. INC.~09296~1~IM~RA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0296903	11/15/2007	MA	60.0	60		F	11/06/2007	Soreness of the (L) deltoid without swelling/redness or ecchymosis. Tenderness of the injection site only. Pt requested report be made.				Y					U	11/01/2007	11/03/2007	2	N/A	PUB	PUB	Levoxyl, Wellbutrin, Premarin, Omeprazole	N/A	Allergies - anti-inflammatories (Abd pain); Phenergan			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U2490AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296905	11/15/2007	CT	73.0	73		F	11/06/2007	Swelling, redness, pain entire upper arm and spreading down to forearm - lasted 3 days - no fever; Took Benadryl, chlor-Trimeton and antibiotic cephalexin and ice				Y					Y	10/10/2007	10/10/2007	0		PVT	OTH	Plavix; Levothyroxine; Zetia; Amlodipine; Lisinopril; Atenolol					1						1	Erythema; Oedema peripheral; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~2~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0296906	11/15/2007	NC	18.0	18		F	11/01/2007	Increased HA, N/V within 6 hours after shots lasting about week after 1st dose, with 2nd dose same symptoms lasting about 24 hours.									Y	10/12/2007	10/12/2007	0	10/25/07 sedrate was high	PVT	PUB	Vyvanse, Septra OS, Phenergan, Clarinex, Z-pak		Asthma			1						1	Headache; Nausea; Vaccine positive rechallenge; Vomiting	FLU3~SANOFI PASTEUR~U2461BA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0523U~2~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2329AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B019AA~1~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0296908	11/15/2007	AZ	18.0	18		F		Patient did not know she was pregnant at time of vaccine administration.										12/19/2006				PVT	PUB		None				1						1	Drug exposure during pregnancy	FLU3~SANOFI PASTEUR~U2220BB~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1095F~2~UN~RA~HEP A (VAQTA)~1|HPV4~MERCK & CO. INC.~0523U~UNK~UN~LA~HPV (GARDASIL)~1	USA		Influenza
0296909	11/15/2007	MA	42.0	42		F		Chills, fever, 40 F, muscle pain, body pain, and cellulitis on right arm.										10/24/2007	10/26/2007	2	Cellulitis	PUB	PUB						1						1	Cellulitis; Chills; Myalgia; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0296911	11/15/2007	MT	58.0	58		F	10/22/2007	swelling, discomfort, and heat redness; Ice and Ibuprofen, Benadryl at Nite-									Y	10/18/2007	10/19/2007	1		PVT	PVT		None				1						1	Discomfort; Erythema; Skin warm; Swelling	FLU3~SANOFI PASTEUR~U2498AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296912	11/15/2007	NJ	81.0	81		M	11/07/2007	FLU SHOT GIVEN APPROXIMATELY 12:00 PM ONSET SYMPTOMS 11/7 PERSISTENT RUNNY NOSE, SCRATCHY SORE THROAT LOW GRADE FEVER, CHILLS NOW PRODUCTIVE COUGH ACHING BODY, CONGESTION, TREATMENT WAS SYMPTOMTIC, DECONGESTANTS, ANTIHISTAMINES REST AND HYDRATIENS									N	10/26/2007	11/02/2007	7		UNK	OTH	ZESTRIL	NONE	HYPERTENSION			1						1	Chills; Nasal congestion; Pain; Pharyngolaryngeal pain; Productive cough; Pyrexia; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296914	11/15/2007	NH	28.0			F	11/03/2007	Shortly after receiving influenza vaccine individual began experiencing local burning/irritation. Exam revealed erythema. 5 x 5 at side site of sxs.									U					MIL	MIL		None	None			1						1	Burning sensation; Injection site erythema; Skin irritation	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296915	11/15/2007	OR	66.0	66		M	11/05/2007	Coughing,Throwing up - 2 days; aching all over, Headache, Slightly dizzy - 4 days; eyes blury, nose running, no appetite, breath less - 9 days; fever 103 deg 1st day, Low grade 4 days; still somewhat breathless and Lethargic 2 wk Later but generally ok.									Y	10/22/2007	10/22/2007	0	none	PVT	OTH	Clonzepam 1 mg; Sertraline 100 mg; Omeprazole 20mg	none	acid reflux	none~ ()~~0.00~In Patient|none we know of~ ()~~0.00~In Sibling		1						1	Anorexia; Cough; Dizziness; Dyspnoea; Headache; Lethargy; Pain; Pyrexia; Rhinorrhoea; Vision blurred; Vomiting	FLU3~SANOFI PASTEUR~42488AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296916	11/15/2007	CA	49.0	49		M	11/07/2007	Generalized redness/itchy, rash minutes after flu (urticaria/generalized erythema).				Y					Y	10/09/2007	10/09/2007	0		PUB	PVT		none	none			1						1	Erythema; Generalised erythema; Pruritus; Rash; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA300AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296917	11/15/2007	IN	21.0	21		F	11/07/2007	Patient has aching, decreased Range of Motion in shoulder where vaccine was administered. Saw Dr. 11-7-07 for these complaints - given RX for antiinflammatory medication and physical therapy									U	10/24/2007	10/24/2007	0		OTH	PVT	No		No			1						1	Injected limb mobility decreased; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA296FA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296919	11/15/2007	MO	52.0	52		F	11/08/2007	headache starting 2 days after vaccine. Bells palsy in left side of face 3/31/08-records received for DOS 10/31/07-Impression: Bell's palsy. C/O headache began several days ago followed by left facial droop. Noticed lack of taste.									N	10/31/2007	11/02/2007	2	MRI, MRA, Intercranial angiogram 3/31/08-records received-MRI and MRA normal. Cerebral angiogram: no cerebral aneurysm reliably seen.	PUB	UNK	Lamictal Fexafenadine	No	No			1						1	Facial palsy; Headache	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296922	11/15/2007	AZ	4.0	4		F	10/29/2007	none state									Y	10/10/2006	10/29/2007	384		PVT	PVT	Claritin, Flovent, Albuterol	none	none			1						1	Unevaluable event	DTAP~SANOFI PASTEUR~C2405AA~5~UN~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2176GA~5~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Y1049~4~SC~UN~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0662F~2~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0296923	11/15/2007	OH	43.0	43		F	11/06/2007	Client called Health Dept stating she had received flu vaccine w/i last 30 mins and now had headache, and felt numb!! also neck pain.									U	11/06/2007	11/06/2007	0	none	PUB	PUB		none known				1						1	Headache; Hypoaesthesia; Neck pain	FLU3~SANOFI PASTEUR~U2505AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296924	11/15/2007	WI	62.0	62		F	10/29/2007	Dx Bacterial and Viral Pharyngitis, onset 2 days after Influenza Vaccine				Y					Y	10/18/2007	10/21/2007	3		PVT	PVT	HCTZ	No	Allergy: PCN, Med. conditions HTN			1						1	Pharyngitis bacterial; Viral pharyngitis	FLU3~SANOFI PASTEUR~U2437AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296925	11/15/2007	WI	70.0	70		M	10/29/2007	Bacterial and viral pharyngitis, sinusitis.  Onset 2 days after receiving flu vaccine.				Y					Y	10/18/2007	10/21/2007	3		PVT	PVT	Lisinopril, Metoprolol, Glipizide, Flomax, Prilosec, Plavix, Digoxin, Bumex, Advocan, Metformin, Allegra, Flonase NS	No	Allergic to Ampicillin; DM, HTN, CVA, hypercholesterolemia			1						1	Pharyngitis bacterial; Sinusitis; Viral pharyngitis	FLU3~SANOFI PASTEUR~U2437AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296926	11/15/2007	WI	4.0	4		F	11/08/2007	She was vaccinated on Monday 11/5. The next day she had a fever of 105 and she was taken to an ER. Her arm swelled up and she was seen in our clinic on 11/7 and put on Duracef. Today her temp is 102.8. Has follow-up appt 11/9 but will return sooner if swelling increases				Y					Y	11/05/2007	11/06/2007	1		PVT	OTH	none	none	cystic kidney disease			1						1	Injection site swelling; Oedema peripheral; Pyrexia	FLU3~SANOFI PASTEUR~U2476HA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~0993U~1~IM~LA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0296927	11/15/2007	NJ	75.0	75		F	11/07/2007	Flu shot 1:30 PM at Acme Oct26-Fri.  Fri Nov2-started with cough, scratchy throat.  Sat Nov3-chills, fever, persistent cough, headache, runny nose and aching body.  Nov4-continue with symptoms.  Nov5-continue with symptoms.  Nov6-symptoms less severe, still dry cough, congestion & runny nose.									N	10/26/2007	11/02/2007	7		OTH	OTH	Avalide, Levothyroxin, Fosamax	None	None			1						1	Chills; Cough; Headache; Nasal congestion; Pain; Pyrexia; Rhinorrhoea; Throat irritation	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0296928	11/15/2007	MI				F	10/24/2007	9:30/A Pt. felt faint and was placed back in a chair as she had begun to leave clinic.  BP 78/58 et 15 mins later 9:50/A 100/60 (client had not eaten prior to clinic).  She was given juice, fanned et placed a cold cloth on her neck, upper back.  Left clinic at 10AM in good condition.  Mom instructed to observe et get her something to eat immediately.  Also to eat prior to attending next clinic.									Y					PUB	PUB	None	No	None present	No~ ()~~0.00~In Patient|No~ ()~~0.00~In Sibling|No~ ()~~0.00~In Sibling		1						1	Blood pressure; Dizziness	FLU3~SANOFI PASTEUR~U2437AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB200AA~1~IM~RA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~0387U~1~IM~RA~HPV (GARDASIL)~1|TDAP~SANOFI PASTEUR~C2644AA~6~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0296931	11/15/2007	WA	66.0	66		F	11/09/2007	Swollen area at injection site, approx 1900, 3 x 3, lump area is warm, really sore.									Y	11/08/2007	11/08/2007	0		PUB	PVT	Crestor 20 mg qd					1						1	Injection site mass; Injection site pain; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1005F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296933	11/15/2007	VA	33.0	33		F	11/05/2007	Pain, redness, swelling at injection site.				Y					Y	11/01/2007	11/01/2007	0		OTH	PVT						1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2526AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296934	11/15/2007	PA	79.0	79		M	11/05/2007	Itching-started 11/2/07 approx. 8 or 9pm.  Hives-when woke up Sat. 11/3/07 on arms, head, shoulder & back.  Seen by Dr.				Y					Y	11/01/2007	11/02/2007	1	Not done	PUB	UNK	Prosec, Xanax	None	Hay fever, anxiety & depression for 20 yrs			1						1	Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA309BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0296935	11/15/2007	TX	5.0	5		M	11/07/2007	11/4 Right arm swollen, red, hot from shoulder to elbow.  11/5 Increased swelling, same redness.  Afebrile.  Axilla/lymphadenopathy, decreased pain.  Cellulitis vs vaccine reaction, clindamycin po.  Recovering.									N	11/02/2007	11/04/2007	2		OTH	PVT		None	None			1						1	Cellulitis; Injection site erythema; Injection site swelling; Injection site warmth; Lymphadenopathy; Vaccination complication	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81108~7+~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0296936	11/15/2007	CA	14.0	14		F	11/06/2007	4 year old female - onset of dizziness with seeing dark dots approx. 15 min after given vaccines									Y	11/06/2007	11/06/2007	0	none	PVT	PUB	none	none	none			1						1	Dizziness; Visual disturbance	FLU3~SANOFI PASTEUR~U2509AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0524U~1~UN~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2330AA~1~UN~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2770AA~1~UN~LA~TDAP (ADACEL)~1	USA		Influenza
0296938	11/15/2007	UT	55.0	55		F	11/06/2007	Patient received a flu mist vaccine at age 55 No signs or symptoms of any reaction									Y	10/30/2007				OTH	MIL						1						1	Inappropriate schedule of drug administration; No adverse reaction	FLUN3~MEDIMMUNE VACCINES, INC.~500484P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0296940	11/15/2007	NC	28.0	28		F	11/02/2007	Large local reaction, 725 cm at subcut L arm.  Swelling, pain, erythema, fever.				Y					Y	10/29/2007	10/30/2007	1		OTH	PVT	Singulair, Allegra, birth control	None	Seasonal & pet hair allergies, asthma			1						1	Erythema; Local reaction; Oedema peripheral; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U2527AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0001F~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0296941	11/15/2007	NC	14.0	14		F	11/08/2007	Hives starting 72-96 hours after administering vaccines. Persisted 4-5 days with hive at site of injection on right deltoid; Treatment with benadryl. This is in follow-up to report (s) submitted on 11/14/2007; 2/7/2008. Information has been received from a pharmacist concerning a 14 year old female with a history of asthma, allergic rhinitis, GERD, psoriasis, eczema, and multiple allergies (dust mites, pollen, grass, ragweed, pine needles, and oak) who on 14-OCT-2007 was vaccinated intramuscularly in the right deltoid with HPV (LOt # 658558/1061U). On 17-OCT-2007 the patient experienced a minor rash. On 18-OCT-2007 the rash increased to go all over the patient's body and she was given BENADRYL. The hives were reappearing on and off by day 3. On 19-OCT-2007 the patient was ok, however later that evening the patient got hives and took BENADRYL again. The patient was taken to the pediatrician on 20-Oct-2007 and was told to take BENADRYL around the cklock. On 22-OCT-2007 the patient got hives again, and one big hive, the size of a pencil eraser appeared at the injection site. After an additional dose of BENADRYL, the hives resolved. MEANCTRA and flu vaccines were administered in the other deltoid at the same visiit. The patient had not been tested for any yeast allergies.									Y	10/14/2007	10/18/2007	4	none	PVT	PVT	Concomitant therapy given intramuscularly in the left deltoid included INFLUENZA virus vaccine (unspecified) (Lot # U2435AA) and MENACTRA (Lot # U2375BA) given intramuscularly in the left deltoid.		asthma, allergic rhinitis, GERD, psoriasis, eczema			1						1	Injection site urticaria	FLU3~SANOFI PASTEUR~U2435AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1061U~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2375BA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0296943	11/15/2007	AZ	8.0	8		M	10/26/2007	Developed fever of up to 103 deg, racing heart rate over 6 days following vaccine. Seen at Medical Center and diagnosed with pneumonia. Antibiotic, Rocephin IV administered, rx of Zithromax given.				Y					Y	10/18/2007	10/19/2007	1	Chest X-ray positive LU infiltrate CBC-normal; blood cultures negative	PVT	PUB	See attached; Omeprazole; Kepra ; Gylcolax; Kepra; Metoclopran; Albuterol; Claritin; Motrin	none	Static encephalopathy with MR/Seizure d/o/Cerebral palsy			1						1	Blood culture negative; Chest X-ray abnormal; Full blood count normal; Palpitations; Pneumonia; Pyrexia	FLU3~SANOFI PASTEUR~U2490AA~6~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296944	11/15/2007	GA	4.0	4		M	11/07/2007	R arm swollen and hot to touch.									Y	11/03/2007	11/04/2007	1		PVT	PVT	None	None	None			1						1	Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~62446AA~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296945	11/15/2007	WA	4.0	4		F	11/07/2007	none stated									U	11/06/2007	11/07/2007	1	none	PVT	UNK		none	none			1						1	Unevaluable event	DTAP~SANOFI PASTEUR~C2606AA~5~UN~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2490AA~4~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB213AA~2~UN~RL~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~Z0873~4~UN~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0203U~2~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1326U~2~UN~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0296947	11/15/2007	MI	4.0	4		M	11/07/2007	Patient given influenza vaccine (listed below) 0.5ml dose at 1524 and mom noted bumps on his face (1535). Child brought back to exam room and assessed by Dr.. Hives to bilateral cheeks but no respiratory distress or complaint of chest pain or tightness. mild itching sensation to face. Treated with 2.5ml Zyrtec by mouth with Benadryl 1 tsp by mouth to be given before bed. Hives completely gone by 11/8/07 morning.									Y	11/07/2007	11/07/2007	0		PVT	PVT	Miralax Prn; Claritin Prn	NONE	NKMA, Allergic rhinitis			1						1	Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U2526AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296948	11/15/2007	NV	58.0	58		F	11/08/2007	Pain and Lump on Right Arm Pain And Stiffness. Traveled up Shoulder And Neck. Shoulder And Neck Still Stiff And Sore 11-9-7									N	10/30/2007	10/31/2007	1	NONE	MIL	OTH		CmL	CmL			1						1	Mass; Musculoskeletal stiffness; Neck pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~UA316BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296949	11/15/2007	MN	31.0	31		F	11/12/2007	Employee developed a hot, burning sensation and an area of erythema on left jaw line and neck, measuring 2 1/2  x 4 within one hour of having FluMist administered. Complained of itch. No breathing difficulties. Used Benadryl Cream and cool compress. Erythema resolving after 24 hours. Had Flumist in 2006, without problems.									Y	11/08/2007	11/08/2007	0		OTH	PVT	none	none	none			1						1	Burning sensation; Erythema; Feeling hot; Pruritus	FLUN3~MEDIMMUNE VACCINES, INC.~500480P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0296950	11/15/2007	NM	33.0	33		M	11/07/2007	Left upper arm warm, swollen, warm to touch. Treated with Clairtin Benadryl				Y					U	11/05/2007	11/06/2007	1		PVT	PUB			Eczema			1						1	Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2475GA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296951	11/15/2007	VA	71.0	71		F	11/09/2007	Redness (about 2 inches diameter) soreness, swelling and itching at the site of injection for about a week. Joints (injected arm) were also sore.									Y	10/30/2007	11/07/2007	8	NONE	MIL	MIL	Elavil, Omeprazole, Clonzepam, caltrate +600, cinnamon capsel, B-12, vit C	DIABETES (NO MEDICATION)	SEASONAL ALLERGIES, SENSITIVE TO MEDICATIONS, PERFUMES			1						1	Arthralgia; Injection site erythema; Injection site pain; Injection site pruritus; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~1080U~UNK~UN~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0296952	11/15/2007	CA	19.0	19		F	10/25/2007	10/25 (2 days post vaccine administration) patient presents with increased swelling, increased redness, increased warmth, increased pain, decreased range of motion in left shoulder - site of Flu vaccine 10/23/07									U	10/23/2007	10/24/2007	1		PVT	PVT		none	PCN -allergy			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Joint range of motion decreased	FLU3~SANOFI PASTEUR~U2443AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296955	11/15/2007	MI	5.0	5		F	11/08/2007	Patient presented to ER with the of Seizure activity witnessed at home.				Y					Y	11/08/2007	11/08/2007	0	CT. Head, CBC, Basic Metabolic profile, UA	PVT	OTH	None	No	None			1						1	Convulsion; Full blood count; Metabolic function test; Scan brain; Urine analysis	FLU3~SANOFI PASTEUR~U2479BA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296956	11/15/2007	CA	62.0	62		F	11/06/2007	extreme back pain so severe went to ER: extreme chest pain so severe went to ER; continuing pain and muscle spasms for nearly 3 weeks; continued testing, medication, and phy. visits; off of work on sick LEAVE (necessary				Y					N	10/17/2007	10/18/2007	1	EKG; Mammogram; CAT SCAN twice - Chest Xray - Sonargram; Blood drawn 3 times	PVT	PVT		none	asthma - sulfa drug - aspirin- laminaria - keratoconus			1						1	Back pain; Blood test; Chest X-ray; Chest pain; Computerised tomogram; Electrocardiogram; Mammogram; Muscle spasms; Ultrasound scan	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79898~1~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0296958	11/15/2007	IL	50.0	50		F		Patient complained of pain in shoulder that radiated down her arm and to her back.									Y	11/02/2007	11/02/2007	0	None	OTH	OTH			Patient reported fibromyalgia before receiving vaccination			1						1	Back pain; Musculoskeletal pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2514AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296959	11/15/2007	FL	79.0	79		F	11/09/2007	5 min. after flu shot: paleness, weakness, dizziness and nausea; later: very fast heart beat that woke me up - called Hosp. for info. they sent ambulance to ER. nex day: some swelling, redness and pain at site of shot.				Y					Y	10/09/2007	10/09/2007	0	At ER Doctor dint seem to think the flu shot was responsible - I was given an injection of Benedryl 10 mg. P.P.D TB Test	OTH	OTH			Dolobid-Renova-Lovastin- P.P.D TB Test- Tusin cough sirup			1						1	Asthenia; Dizziness; Heart rate increased; Injection site erythema; Injection site pain; Injection site swelling; Nausea; Pallor; Skin test	FLU3~SANOFI PASTEUR~02491A~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296962	11/15/2007	CA	0.5	0	.5	F	11/05/2007	5 minute tonic clonic seizure following vaccines. approx. 16 hours after vaccine, released with diagnosis of febrile seizures.				Y					Y	11/02/2007	11/03/2007	1	none	PVT	PVT		no	no			1						1	Febrile convulsion; Grand mal convulsion	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B125AB~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2456FA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF113AA~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B53981E~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0778F~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0296963	11/15/2007	UT	4.0			M	11/08/2007	Patient presented 24 hours after injection with redness and swelling, pain in thigh. Given Benadryl for allergic RXN.									Y				none	PUB	PUB	none	none	none			1						1	Hypersensitivity; Injection site erythema; Injection site pain; Injection site swelling	DTAP~SANOFI PASTEUR~C2650AA~5~UN~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2504AA~3~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296964	11/15/2007	FL	27.0	27		M	11/05/2007	Vomiting, lightheaded, very weak. Started Saturday, better Sunday, pain left side, throat was swollen.									Y	10/30/2007				MIL	UNK						1						1	Asthenia; Dizziness; Pain; Pharyngeal oedema; Vomiting	ANTH~EMERGENT BIOSOLUTIONS~FAV112~UNK~UN~UN~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~UT2460AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~SANOFI PASTEUR~Z0664~UNK~UN~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0296965	11/15/2007	IN	27.0	27		F	11/06/2007	See attached (back of form); INFLENZA GIVE at 1145Am. At approx 1245Am the patient had itching 1 Pm Felt weird. Went outside to get air Sit down with head between knees Fainted Nurse called 911 called. When Nurse arrived patient was in and out of conscientiousness; Smelling salts used. -medics arrived started IV fluids - Gave Benadryl Breathing poor - gave 02 B/P 215/120 HR 127; Stayed in ER until 6 Pm; While in Hospital had Cat Scan EKG. Placed on Heart Monitor and given more IV fluids for dehydration. Woke up next morning with Migraine went to MD. Had Sinus Infection. Placed on antibiotics 11/1/07 Patient doing fine				Y						10/24/2007	10/24/2007	0		PUB	PVT			Seizures under control - Migraines			1						1	Dehydration; Dyspnoea; Feeling abnormal; Heart rate increased; Hypertension; Loss of consciousness; Migraine; Pruritus; Sinusitis; Syncope; Altered state of consciousness; Computerised tomogram; Dyspnoea; Electrocardiogram; Hypoaesthesia; Loss of consciousness; Migraine; Pruritus generalised; Syncope; Viral infection	FLU3~SANOFI PASTEUR~V02464AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2464A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0296966	11/15/2007	IN	53.0	53		F	10/23/2007	10-9-07 SHOT ADMINISTERED; 10-10-07 Nausea - Shoulder Blade pain - muscle spasms; 10-11-07 Pain spread to back then down arms; 10-12-07 Pain and spasms Head and Temple Continual Burning feeling. ER visit MD stated Flu shot problems; 10-15-07 WENT TO OWN MD. Put on Valium Muscle Relaxant and Pain med; 110-31-07 Doing well now				Y					Y	10/09/2007	10/10/2007	1	MD diagnosed post results of Flu Shot	OTH	PVT						1						1	Burning sensation; Muscle spasms; Musculoskeletal pain; Nausea; Pain	FLU3~SANOFI PASTEUR~U2464AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296967	11/15/2007	MO	45.0	45		F	11/08/2007	FOLLOWING VACCINATION ON 11/2/07, THREE DAYS OF HIGH FEVER (104 DEG F, 103 DEG F) AND ONE DAY OF 101 DEG TEMP.									Y	11/02/2007	11/03/2007	1		OTH	PVT	ALLEGRA D	UNKNOWN	SEASONAL ALLERGIES			1						1	Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3122AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0296968	11/15/2007	NJ	55.0	55		F	11/09/2007	10/29/07 350 pm Shot given; 530 pm Headache severe, very sore, ill, weak feeling; 750 pm excessive coughing, wheezing, hoarse, sore throat; Hoarse and Sore Mouth, tongue lasted for 2days									Y	10/29/2007	10/29/2007	0		OTH	PUB	Topamax, Soma, Actonel	RSD, fibromyalgia				1						1	Asthenia; Cough; Dysphonia; Glossodynia; Headache; Malaise; Oral pain; Pain; Pharyngolaryngeal pain; Wheezing	FLU3~SANOFI PASTEUR~U2527AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296970	11/15/2007	TX	61.0	61		F	11/11/2007	Swelling of left arm									U	11/07/2007	11/08/2007	1		OTH	PVT		none				1						1	Oedema peripheral	FLU3~SANOFI PASTEUR~U2487AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0555U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296971	11/15/2007	AR	28.0	28		M	11/15/2007	puritic rash; Prednisone 10mg, tapering dose									U	11/08/2007	11/09/2007	1	NONE	OTH	PUB		NONE	NONE			1						1	Rash pruritic	FLU3~SANOFI PASTEUR~U2469AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296972	11/15/2007	TN	1.2	1	.2	M	10/22/2007	Sudden onset of high fever (104.4), chills, hands, arms and chest, cool and clammy to touch. Difficulty Breathing, behavior changes -> lethargy and small raised hives around injection site. Symptoms started approx 8 hours after vaccination.				Y					Y	10/19/2007	10/19/2007	0	Chest X-ray and throat culture	PUB	PUB	Singular; Pulmcort	none	Asthma			1						1	Abnormal behaviour; Chest X-ray; Chills; Cold sweat; Culture throat; Dyspnoea; Injection site urticaria; Lethargy; Pyrexia	FLU3~SANOFI PASTEUR~UT2474AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296974	11/15/2007	CA	40.0	40		M	11/09/2007	Fever 101 deg F; red injection site; syncope but had labs drawn 15 hours  and told PPD was positive; 22 Ga 1 needle									Y	10/31/2007	11/02/2007	2	labs drawn	PUB	PUB	none	none	none			1						1	Injection site erythema; Laboratory test; Pyrexia; Syncope; Tuberculosis skin test positive	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79849~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C2771AA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0296975	11/15/2007	CA	62.0	62		M	11/02/2007	Had flu shot at 11:00 at 5pm Had Sudden onset of Dizzyness and nausea Vomited x3-4, went to ER Had Ct scan Diz- meclozine with relief Today feels Weak and tired today; 11/5 feels better no more dizzyness or vomiting pMD Stated Not related to flu Shot Vertigo				Y					Y	11/01/2007	11/01/2007	0	Had CT Scan at Hospital	PUB	PVT	S allopurinol=gout; High BP med Lisinopril	none	gout and HTN			1						1	Asthenia; Computerised tomogram; Dizziness; Fatigue; Nausea; Vertigo; Vomiting	FLU3~SANOFI PASTEUR~U2463AA~5~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296976	11/15/2007	WA	53.0	53		F	11/14/2007	Registered Nurse administered Flu shot and there were no immediate issues - The following morning my shoulder was sore it got progressively worse. Range of motion is limited, waking up at nite due to									N	11/01/2007	11/02/2007	1	None	PVT	PVT	Levoxyl for thyroid and Vicodin for pain	NO	None			1						1	Joint range of motion decreased; Musculoskeletal pain; Sleep disorder	FLU3~SANOFI PASTEUR~U2463AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296977	11/15/2007	WA	7.0	7		M	11/12/2007	Warm, red, Swollen 3 erythemia 2 inches induration on left upper arm.									Y	11/07/2007	11/07/2007	0	none	PVT	PUB	none	none	none, nka			1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80958~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARCEL~MERCK & CO. INC.~1174U~3~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0296978	11/15/2007	IL	56.0	56		F	11/15/2007	States left arm still hurts from injection at injection site especially when rolling over in bed or when lifting left arm									Y	10/23/2007	10/23/2007	0		PUB	PVT		None				1						1	Injected limb mobility decreased; Injection site pain	FLU3~SANOFI PASTEUR~U2478AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296980	11/15/2007	TN	0.8	0	.8	M	10/31/2007	Fever 105.0 deg F; Broke out - Rash Red Splotches (hives) (per Mother's Report); ER visit 10-30-07 (pm) (per Mother's report); 103/07 call from Mother re: child's condition improved today.				Y					Y	10/30/2007	10/30/2007	0	Seen in ER. Also Diagnosed with Ear Infection	PUB	PUB		None noted.	nka. none noted.			1						1	Ear infection; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~UT2459AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296981	11/15/2007	FL	14.0	14		F	11/15/2007	SWELLING AND REDNESS 85x70 area left deltoid. No systemic symptoms. IBUPROFEN AND COLD COMRESS ADVISED				Y					U	11/14/2007	11/14/2007	0		PUB	PUB		NONE	NONE			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~UT047433~1~ID~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U230BA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0296983	11/15/2007	MI	6.0	6		M		Stomach ache. Developed SOB, mucosa edema, puffy eyelids erythema and abo pain within 5 mins. 0.15ml epi given immediately. 2 tsp benadryl. 30 mg ora pred give. Fully recovered 45 min after event				Y					Y	11/02/2007	11/02/2007	0	See attached - allergy testing; 11/09/2007 EGG WHITE 0.35; FISH,COD 0.35; MAIZE, CORN 1.28M; MILK 0.50L; PEANUT 0.45L; SCALLOP 0.35; SHRIMP 0.35; SOYBEAN 0.70L; WALNUT 0.74M; WHEAT 1.27M; No Egg Allergy noted in Blood test.	PVT	UNK		None	cranial synostosis	Same~DTaP (no brand name)~UN~5.00~In Patient		1						1	Abdominal pain; Abdominal pain upper; Allergy test; Blood test; Dyspnoea; Erythema; Eyelid oedema; Oedema	FLU3~SANOFI PASTEUR~U2526AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB211AA~1~IM~LA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1256U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0296985	11/15/2007	WA	3.0	3		F	11/15/2007	6cm erythema, warmth around injection area. Treated cellulitis with keflex x10 days									U	11/13/2007	11/14/2007	1		PVT	PUB						1						1	Cellulitis; Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U2490AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1343U~2~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0296986	11/15/2007	WA	5.0	5		F	11/14/2007	Hive-like rash over face, neck, trunk and LE with papulars from .5cm-10cm in diameter. No vesicles. Treated with anti-itch therapy oraly.									U	11/05/2007	11/11/2007	6		PVT	UNK		NONE	NONE			1						1	Rash generalised; Rash papular; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500489P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~Z1069-2~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|VARCEL~MERCK & CO. INC.~1343U~2~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0296992	11/15/2007	NE	64.0	64		F	11/06/2007	Noted bruising at site (dime-size) on 11/1/07 3 inch area of redness noted on 11/3/07. Patient denies swelling or pain at site.									Y	10/31/2007	11/01/2007	1	none	PVT	OTH	Anti-hypertensive medication	no	Hypertension.			1						1	Injection site bruising; Injection site erythema	FLU3~SANOFI PASTEUR~U2528AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296995	11/15/2007	MO	1.0	1	.0	M	11/15/2007	Vesicles to vaccine site of Left upper outer arm with continued redness.				Y					Y	10/30/2007	11/08/2007	9		PVT	PVT						1						1	Injection site erythema; Injection site vesicles	FLU3~SANOFI PASTEUR~UT2473GA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0184U~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~354007F~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0675U~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0296996	11/15/2007	IA	48.0	48		M	11/07/2007	Right arm at armpit, on torso has swelling 3cmx4cm Round sore, area. Onset Date was 11/3/07									Y	11/01/2007	11/03/2007	2	Saw Physician	PUB	PUB	Ibuprofen; Lipitor	recovering From GI virus	Leukemia			1						1	Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2449AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0380U~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0296997	11/15/2007	CO	4.0	4		M	11/15/2007	11/11 left arm swollen and hot to touch at shot site Recv'd 11/9/07				Y					Y	11/09/2007	11/11/2007	2		PVT	PVT	none	none	none			1						1	Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2512AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0296998	11/15/2007	MI	36.0	36		F	11/15/2007	About 4 hours post flu shot noticed gradual onset mild dull achey chest pain wheezing, sore throat, started, started non-productive cough, very dry and reddened eyes. Around 7 pm felt mild nausea and sweaty hands. Client researched her symptoms and believes she experienced O.R.S, - Ocalo-Respiratory Syndrome symptoms resolved by next day. (Self-diagnosis)									Y	10/31/2007	10/31/2007	0	- none performed- Allergies: Sulfa, minocycline tetracycline antibiotics and IV ferrlecit.	OTH	PVT	Synthroid, Prilosec and birthcontrol pills	- none -	Mild exercise induced asthma; autoimmune thyroid condition; Allergies: Sulfa, minocycline tetracycline antibiotics and IV ferrlecit	(NONE)~ ()~~0.00~In Patient		1						1	Chest pain; Cough; Dry eye; Hyperhidrosis; Nausea; Ocular hyperaemia; Pharyngolaryngeal pain; Wheezing	FLU3~SANOFI PASTEUR~U2466AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296999	11/15/2007	MN	50.0	50		F	11/15/2007	Client experienced severe pain, decreased range of motion, swelling of the upper right arm post Flu Shot. Client went to MD clinic and to an Emergency Room twice Initially treated with Flexeril, Percocet, hot and cold packs. After the M.R.I. - she received a steroid injection into right upper arm with significant symptom relief.				Y					Y	10/10/2007	10/10/2007	0	M.R.I. -(11/02/07) Diagnosed with acute subacromial bursitis.	OTH	PVT		none	unknown			1						1	Bursitis; Joint range of motion decreased; Nuclear magnetic resonance imaging; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2466AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299675	11/15/2007	NC	14.0			F	11/14/2007	This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a pharmacist concerning a 14 year old female with a history of asthma and multiple allergies (dust mites, grass, weeds, and others) who on 14-OCT-2007 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included influenza virus vaccine (unspecified) and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) in the other deltoid. On 17-OCT-2007 the patient experienced a minor rash. On 18-OCT-2007 the rash increased to go all over the patient's body and she was given Benadryl. The hives were reappearing on and off by day 5. On 19-Oct-2007 the patient was ok, however later that evening the patient got hives and took BENADRYL again. The patient was taken to the pediatirician on 20-Oct-2007 and was told to take BENADRYL around the clock. On 22-OCT-2007 the patient got hives again, and one big hive, the size of a pencil eraser appeared at the injection site. After an additional dose of BENADRYL, the hives resolved. MENACTRA and flu vaccines were administered in the other deltoid at the same visit. The patient has not been tested for any yeast allergies. Additional information has been requested.				Y					U	10/17/2007	10/17/2007	0	None	OTH	OTH			None; Asthma; Hypersensitivity		WAES0710USA04833	1						1	Injection site urticaria; Rash generalised; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~1~IM~AR~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~~UNK~UN~AR~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0299825	11/15/2007	NY	15.0	15		F	11/14/2007	Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). In October 2007, about a week ago, the patient was vaccinated with a second doses of HPV rL1 6 11 16 18 VLP vaccine (yeast) 0.5 ml IM. Concomitant therapy included influenza virus vaccine (unspecified) also given on the same date in October 2007. In October 2007, about 24 hours after being vaccinated, the patient developed a headache, dizziness, and vomiting and was hospitalized.  At the time of reporting, the patient had not recovered. The physician felt that the events were disabling. Additional information has been requested.  03/03/2008 MR received for DOS 11/8-11/2007 with DX: Headache Disorder, Intractable Migraine. Pt presented with 2 1/2 week hx of throbbing headache in the forehead, bitemporal, and occipital areas which began 1 day s/p flu and Gardasil vax.  H/A associated with nausea, dizziness, light and noise sensitivity.  Occasionally wakes from sleep with pain. Previous ER visit with normal diagnostics.  PE WNL.				Y	Y	4		Y	N	10/21/2007	10/22/2007	1	A magnetic resonance imaging (MRI) was performed, results not reported.  Labs and Diagnostics: LP (-), CT WNL, MRI WNL, blood tests all WNL (done at previous ER visit). Urine Tox screen (-).	OTH	OTH			Unknown. PMH:  asthma.  NKDA.		WAES0710USA07046	1						1	Dizziness; Headache; Vomiting; Blood test; Computerised tomogram; Headache; Inappropriate schedule of drug administration; Lumbar puncture; Neck pain	FLU3~SANOFI PASTEUR~02502AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1266U~2~IM~~HPV (GARDASIL)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HPV4~MERCK & CO. INC.~1226U~2~IM~~HPV (GARDASIL)~2	USA	Hospitalisation,Disabling	Influenza
0299825	11/15/2007		15.0	15		F	11/14/2007	Information has been received from a physician concerning a 15 year old female with asthma and a history of ankle sprain who on 23-JUN-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast). On 21-OCT-2007, the patient received the second dose of GARDASIL vaccine (yeast) (lot # 1266U) in one arm and influenza virus vaccine (unspecified) in the other arm. Approximately 24 to 48 hours after the second dose of GARDASIL vaccine (yeast), the patient experienced a headache at the base of her skull and pain in the neck. The patient did not have this adverse reaction after the first dose of GARDASIL vaccine (yeast). Subsequently the patient went to the local emergency room where a neurologist performed CT scans, spinal tap, a major work-up in which all results were normal. The patient's father told the physician that his daughter is still having headaches. Additional information has been requested.				Y					N	10/21/2007	10/22/2007	1		PVT	OTH		Asthma	Ankle sprain		WAES0711USA00084	1						2	Dizziness; Headache; Vomiting; Blood test; Computerised tomogram; Headache; Inappropriate schedule of drug administration; Lumbar puncture; Neck pain	FLU3~SANOFI PASTEUR~02502AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1266U~2~IM~~HPV (GARDASIL)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HPV4~MERCK & CO. INC.~1226U~2~IM~~HPV (GARDASIL)~2	USA	Emergency room visit	Influenza
0300015	11/15/2007		0.5	0	.5	M	11/14/2007	Information has been received from a consumer concerning her 6 month old nephew who on 26-OCT-2007 was vaccinated with a dose of ROTATEQ vaccine live (human-bovine). Other vaccinations received on the same day included influenza virus vaccine (unspecified), (manufacturer unknown), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, (manufacturer unknown), Hib conj vaccine (OMPC) (manufacturer unknown), PREVNAR vaccine (CRM197). In the evening of 26-OCT-2007, it was reported that he was just not acting right. He was awake several times throughout the night with fever (maximum temperature was 101.6 F). By 28-OCT-2007, he had recovered completely. No further information is available.									Y	10/26/2007	10/26/2007	0	body temp - 10/26/07 - 101.6 F	OTH	OTH			Unknown		WAES0710USA06256	1						1	Abnormal behaviour; Body temperature; Poor quality sleep; Pyrexia	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~MERCK & CO. INC.~~UNK~UN~UN~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~~UNK~UN~UN~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~~UNK~UN~UN~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0296884	11/16/2007	CA	70.0	70		M	11/15/2007	Swelling and redness of entire bicep region of right arm from shoulder to elbow. Flu-like symptoms for one day and then cellulitis type infection as described above.				Y					Y	11/09/2007	11/10/2007	1	No tests taken at Urgent Care treatment office. Prescribed Cephalaxen, 500mg, 4x daily, by the attending and examining physician, MD.	UNK	UNK	LISINOPRIL, SIMVASTATIN	None	slightly elevated blood pressure, high cholesterol level, prior bacterial pneumonia, generally in good health at time of vaccinations	none~ ()~~0.00~Patient		1						1	Cellulitis; Erythema; Influenza like illness; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0297007	11/16/2007	OH	0.92	0	.9	F	11/16/2007	Hives 24 hours after flu shot									U	11/12/2007	11/14/2007	2	none	PVT	PVT	none	none	35 week twin			1						1	Urticaria	FLU3~SANOFI PASTEUR~ut2474ca~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297008	11/16/2007	MI	5.0	5		M	11/16/2007	Mother states left arm red, swollen, tender to touch.  Recommended cool compresses or ice to site with Tylenol or Ibuprophen for symptomatic relief.  Mother to call physician on 11/18/2007 of no improvement.									U	11/14/2007	11/15/2007	1	none	PUB	PUB	none	none	none			1						1	Cold compress therapy; Erythema; Oedema peripheral; Tenderness	DTAP~GLAXOSMITHKLINE BIOLOGICALS~ac14b056ca~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~u2489aa~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~4069-2~4~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0416u~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1349u~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0297009	11/16/2007	MD	38.0	38		F	11/16/2007	Flu symptoms appeared 36 hours later - fever, headache. naseua, loss of voice, coughing				Y					Y	11/08/2007	11/09/2007	1		PUB	PVT		None	None			1						1	Aphonia; Cough; Headache; Influenza; Nausea; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0297012	11/16/2007	MN	48.0	48		F	11/16/2007	dizziness last couple of days									U	11/13/2007	11/14/2007	1		UNK	PVT						1						1	Dizziness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0297015	11/16/2007	IN	46.0	46		M	11/16/2007	puritic rash onset approx. 7am on 11/11/07, seen at Bloomington Hospital ED at 1:20pm 11/11/07, Decadron injection, Medrol Dose pack and Vistaril po.  Dx:  erythema multifomre and allergic dermatitis				Y					Y	11/09/2007	11/11/2007	2	none	UNK	UNK	unknown	none	none known			1						1	Dermatitis allergic; Erythema multiforme; Rash pruritic	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA296A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0297016	11/16/2007	AR	54.0			M	11/16/2007	Patient received the flu shot (FluLaval, Lot # AFLLA053AA) at our health fair.  He developed swelling of the tongue with in six hours of taking the shot.  He had no previously known allergies to the vaccine components or contraindications to receiving the shot.  He called the employee health nurse(this writer) the next morning and reported the swollen tongue.  He was advised to see the doctor.  The doctor told him he had an allergic reaction to the flu vaccine.  She gave hime a steroid shot and advised him to get OTC Allegra as an antihistamine.  This morning (the 16th and two days after receiving the shot) he is back at work and reporting the the swelling has greatly decreased.  This writer does not know if the treating physician made a report of this episode.				Y					Y	11/14/2007	11/14/2007	0	Unknown	UNK	UNK	UNKNOWN	No				1						1	Hypersensitivity; Swollen tongue	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLAO53AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0297020	11/16/2007	GA	3.0	4		M	11/16/2007	Developed pain, swelling and redness at site of injection the following day.  This progressed to the point that child required an ER visit due to pain.  Patient has history of hemophilia so there was some concern that this was a muscle bleed, but his hematologist did not think that it was.  On 5 days after the injection, when I saw the patient, his entire upper arm had an erythematous almost ecchymotic appearance with several blister-like lesions.				Y					Y	11/01/2007	11/02/2007	1		PVT	PVT	Advate, Singulair, Qvar	None	Hemophilia A, Spina Bifida, Asthma			1						1	Blister; Ecchymosis; Injection site erythema; Injection site pain; Injection site swelling; Skin lesion	FLU3~SANOFI PASTEUR~42506AA~3~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297023	11/16/2007	OH	66.0	66		M	11/16/2007	Patient developed redness/swelling in left arm within 24 hours of administration, swelling has extended to left wrist.  No systemic symptoms.  Patient provided NSAID and topical steroid therapy.									U	11/14/2007	11/14/2007	0		MIL	MIL	none	none	History of allergic rhinitis/asthma			1						1	Erythema; Oedema peripheral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA063AA~3~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB195AB~UNK~IM~UN~HEP A (HAVRIX)~1|PPV~MERCK & CO. INC.~0554U~1~IM~UN~PNEUMO (PNEUMOVAX)~1|TYP~SANOFI PASTEUR~Z0567~UNK~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|VARZOS~MERCK & CO. INC.~1088U~1~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0297025	11/16/2007	IN	54.0	54		F	11/16/2007	Pt. had Pneumovax and influenza shot both in the right deltoid.  Same day redness, pain, and swelling.  Pt. put ice on it and took ibuprofen, no better.  2 days after the shots, pt. felt hot and cold, had generalized aches, appeared pale, had nausea, and sweating.  In the office, pt. appeared pale, BP 96/68. pulse 112, temp 101.6 F.  No stridor/wheeze.  Area of erythema on right deltoid was 10cm circular, warm, raised.  Pt. was given liquid Benadryl, and liquid Motrin.  After 15 minutes, pt. feeling better, less nausea, BP improved to 108/68, pt. tolerating sips of water.  Total observation for 45 minutes.  Pt. ambulated out of office feeling somewhat better.  VS stable.  Instructed to continue liquid Benadryl and Motrin at home every 6 hours for generalized hives reaction.									Y	10/16/2007	10/17/2007	1	None.	PVT	PVT	Fosamax 70mg, one po weekly.	None.	Osteopenia, pyelonephritis (7/07, resolved)			1						1	Erythema; Feeling of body temperature change; Hyperhidrosis; Nausea; Pain; Pallor; Pyrexia; Skin warm; Swelling	FLU3~SANOFI PASTEUR~70489~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0359F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297027	11/16/2007	MI	80.0	80		F	11/14/2007	Patient complained of a 'poison ivy like rashat the injection site, she spoke with her primary care physician, who told her it was a common occurance for a flu shot and should not be anything to worry about									U	11/10/2007	11/11/2007	1		UNK	UNK	Alprazolam 0.5mg, Lamotrigine 25mg, fosamax 70mg, Levothyroxine 75mcg					1						1	Injection site rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA031AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0297028	11/16/2007	MA	22.0	22		F	11/16/2007	Fever 104 F within 24 hours of vaccination.  Also has vomiting, dry cough, headache and body aches.  Treated with 7 day course of Tamiflu				Y					U	11/15/2007	11/16/2007	1	Instant influenza A/B testing negative	UNK	PVT	Sprintec, Flovent, Allegra	Thought she might be coming down with a cold	asthma, allergy to Sulfa drugs,			1						1	Cough; Headache; Influenza serology negative; Pain; Pyrexia; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80864~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0297037	11/16/2007	FL	69.0	69		M	11/16/2007	On 11/02/2006 I received a Flu shot and a Pneumonia shot. Flu symptoms of aches and listlessness lasted for over two months - Elevated Blood Pressure, pulse rate increase and irregular heart beat started immediatly after receiving the shots and lasted for over six months.  My doctor immediately prescribed blood pressure medication.  When the high blood pressure and arythmia persisted, I had a complete cardiac screening and blood workup.  The symtoms were declared innocent. In the last six months my body has slowly come back to normal.  My pulse is regular, although still higher than previously.  My blood pressure is slightly lower than before, however, I am now on medication...Lisinopril and triamterene.									U	11/02/2006	11/03/2006	1		UNK	UNK	Baby Asprin, Glucosamine/condrotin, celebrex	None	None	none~ ()~NULL~~In Patient		1						1	Arrhythmia; Blood pressure increased; Heart rate increased; Heart rate irregular; Hypertension; Listless; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0297039	11/16/2007	OR	4.0	4		M	11/16/2007	Flumist Saturday 11/03/2007 in am at School clinic by Health Department. Monday 11-05-07 104 degree fever, he was crying because of headaches, congestion, cough.  Better 11-09-07 (sister got headache and fever 102 degree, but better within 24 hours.)									Y	11/03/2007	11/05/2007	2		UNK	UNK		none	none	none~ ()~~0.00~Patient|none~ ()~~0.00~Sibling|non~ ()~~0.00~Sibling		1						1	Cough; Crying; Headache; Pyrexia; Respiratory tract congestion	FLUX~UNKNOWN MANUFACTURER~Flumist~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0297040	11/16/2007	LA	73.0	73		M	11/16/2007	Patient admitted to the hospital with nonspecific paresthesia.  Patient immediately went to the ICU for observation due to questionable pulmonary status, but never required intubation; total ICU stay was 14 days.  Neurology was consulted and diagnosed the patient with Guillain-Barre syndrome.  He was treated with IVIG 36 gm daily for 5 days, with little improvement.  After completing the IVIG he received 5 days of plasmaphoresis.  Upon completion of the plasmaphoresis, he started to show improved strength and swallowing capabilities.  As patient improves it is anticipated that he will be transferred to a skilled nursing unit or inpatient rehab unit to complete his recovery.  11/19/2007 ER record received from 10/29/2007. Pt presented with abrupt onset of numbness of hands and feet, weakness, and feeling poorly. (+) walking difficulty.  PE (+) for ataxia, unsteady and broad-based gait. Loss of sense of touch both hands and leg.  Admitted  with assessment: Hypokalemia.  Weakness. Paresthesias. 11/26/2007 D/C summary recived for DOS 10/30-11/20/2007 with D/C DX:  Guillain-Barre syndrome.  Autonomic Instability.  Aspiration Pneumonia.  Dysphagia.  Peripheral Neuropathy.  Squamous cell carcinoma of the scalp. Neurology consult found no DTRs on PE.  Strength 3/5 and diminished sensation lower extremities.  Prelim DX was ascending sensory motor polyneuropathy, likely GBS.  Pt received IVIG and plasmapheresis with increase in strength noted.  Pt had an episode of aspiration which did not require intubation. Pt experienced orthostatic hypotension and worsening peripheral neuropathy (burning sensation in both legs) during hospital stay. D/C to SNF on 11/20/2007.   12/28/07 Additional records received. Pt re-admitted 11/20-29/2007 for Partial SBO and again 12/5-14/07 for inpatient rehab for mobility impairments.					Y	39			Y	10/12/2007	10/29/2007	17	neurologist made diagnosis. Labs and Diagnostics:  Head CT (-). EKG with 1st' AV block/no ischemic changes.  Abd X-ray with dilated bowel loops read as (-) by ER MD. CMP with K+ 2.6, Glucose 118. CBC with RBC 3.95, HGB 12.5, Hct 36.5.  MRI cervical and thoracic spine normal.  MRI lumbar spine (+) for degenerative changes.  No brain MRI, NCS or EMG done per MR dept	UNK	UNK	None	None	None. PMH:  Squamous and Basal cell carcinoma. Bleeding disorder/anemia.  DM. hepatitis/liver disease. HTN/Heart disease.  NKDA.			1						1	Guillain-Barre syndrome; Intensive care; Paraesthesia; Plasmapheresis	FLU3~SANOFI PASTEUR~U2489AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0297041	11/16/2007	NY	0.5	0	.5	F	11/16/2007	Pediarix and Flu vaccines were given subcutaneously in the patients right leg. Reddness and swelling occured no treatment neccessary									Y	11/16/2007	11/16/2007	0		PVT	PVT	vitamin	none	none			1						1	Erythema; Swelling	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~ac21b124~3~SC~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~ut2460gA~UNK~SC~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~uf210aa~UNK~IM~LL~HIB (ACTHIB)~1	USA		Influenza
0297044	11/16/2007	WA	1.25	1	.2	M	11/16/2007	Fever of 104 on 11/15/2007, white blisters on tongue. Medicated with infant Tylenol drops without a decrease in temperature.  Medicated with Ibuprofen 1.8ML with fever reducing to 102 on day 2 of vaccinations.									U	11/14/2007	11/15/2007	1		PUB	PUB						1						1	Blister; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~ac21b090aa~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~ut2460fa~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~uf164aa~3~IM~LL~HIB (ACTHIB)~1|MMRV~MERCK & CO. INC.~0775u~1~SC~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~b08681e~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0297045	11/16/2007	UT	12.0	12		F	11/16/2007	Hives at site of injection, R arm, measuring 8-9 cm, also itchy hives on neck and chest									U	11/13/2007	11/16/2007	3	none	PVT	PVT		None				1						1	Injection site urticaria; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2440AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2544AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B019AA~1~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0297047	11/16/2007	TX	59.0	59		M	11/16/2007	Received PPV23 and influenza vaccines in right arm 11/14/07 approx 11 a.m. at our Health Dept  influenza immunization clinic. Client stated that approx 3 p.m., arm pain began, self-described as excruciating with loss of range of motion. Stated he took 800 mg ibuprofen approx 6:30 p.m. then Vicodin Plus at 10:30 p.m. Stated at 12:30 a.m. throat felt like it was closing up, I was afraid for my life, I slept sitting up in chair so I could breathe. His spouse notified our flu clinic staff of client condition on 11/15, who advised ER or personal physician follow-up; client contacted his physician who advised trip to ER if breathing problem worsened; client stated arm had pulsating pain on 11/15. On 11/16 during follow-up phone call stated arm still not fully mobile, can't lift it completely. Stated no fever during episode. We advised further contact with his physician as necessary.									U	11/14/2007	11/14/2007	0	none known to date	PUB	PUB						1						1	Injected limb mobility decreased; Joint range of motion decreased; Pain in extremity; Throat tightness	FLU3~SANOFI PASTEUR~U2511AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0675F~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297073	11/16/2007	MA	64.0	64		M	11/14/2007	Demyelinating peripheral neuropathy compatible with Guillian-Barre Syndrome.  12/11/07 Reviewed hospital medical records which reveal patient experienced tingling & paresthesia of hands & feet starting approx 2 wks prior to admit & progressing to include lips & tongue.  Also developed balance & gait difficulty.  Denied any prior illness & had no problem w/flu shot in past.  Admitted 10/30-11/05/2007.  On admit, was areflexic & symmetrical sensory loss of UE & LE which worsened during hospitalization.  LP done.  Patient initially refused IVIG & plasmapheresis due to religious beliefs but during hospitalization did accept IVIG x 5 doses.  There was mild progression of weakness of LEs but no significant extension.  D/C to inpatient rehab. FINAL DX: demyelinating peripheral neuropathy c/w Guillain Barre syndrome.					Y	13			Y	09/29/2007	10/30/2007	31	10/30/07 CPK 948; Lumbar puncture 10/31/07 - elevated protein 107; EMG studies c/w acute Guillain-Barre LABS: MRI WNL.  Admit CPK 948 (H).  CSF protein 107 (H), glucose 100 (H), WBC 2, RBC 9, lymphs 60%, monos 36%, segs 2%.  EMG c/w GBS.	PVT	OTH	PREVACID; LISINOPRIL; FISH OIL; LOPRESSOR; CALCIUM; VITAMIN D	None	Hypertension; Diabetes type 2; Peptic ulcer disease; Osteoarthritis of knee PMH: HTN, type 2 DM, hypercholesterolemia, PUD, OA, bilat TKR.			1						1	Blood creatine phosphokinase increased; CSF protein increased; Demyelination; Electromyogram abnormal; Guillain-Barre syndrome; Lumbar puncture abnormal; Neuropathy peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79239~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0297076	11/16/2007	WI	68.0	68		M	11/13/2007	10/23/07 ER visit. 10/24/07 Doctor saw for bilateral arm and leg myalgia. Rx Oxycodone. 10/27/07 Doctor appointment for recheck; myalgia, labs drawn. 10/31 RNG saw for possible vasculitis. Patient told to continue on Prednisone. 11/09/07 RNG saw patient; admitted to hospital; GI bleed. 11/13/4 Doctor saw for GI bleed. Admitted for GI bleed.  12/17/2007 MR received for ER visit of 10/23/2007 with Dx: Myalgias.  Pt presented to ER with c/o cramping in the low back, starting at the buttocks and descending down to the calves. Cramping also noted in the biceps area. (+) fever and chills.  had similar muscle cramping with some past medications. Txd with pain meds and D/Cd.  Pt admitted 11/9-10/2007 with DX:  Acute GI bleed. Pt has been on prednisone recentlyand ASA and Plavix. Presented with melenic stools and coffee ground and fresh blood emesis. C/o lightheadedness and sweats.  Re-admitted 11/13-16/2007 with sx of dizziness with a Hgb of 7.3 following an upper GI bleed with ulcer. Hgb up to 8.2 after 2 units PRBCs. DX:  Acute blood loss anemia.  Possible GI Bleed.  Recent upper GI bleed.  Transfused 3 units during hospitalization with stablization of Hgb.  Known CAD, LAD drug eluting stent.  EGD showing healing ulcer.  Erythematous esophagus. Diverticulosis seen on colonoscopy.  Flat polyps, not biopsied.  Large hiatal hernia on prior EGD.  Free reflux on prior EGD, documented GERD.  Esophagitis. Gastric cardia nodule, biopsy OK.  Duodenal bulb based ulcer.  Protonix BID tx.  Plavix and ASA on hold.  Hypothyroid, on Synthroid, changed from dessicated thyroid recently.  Reaction to Flu vaccine with possible neuropathy, central vs peripheral.  Ongoing feet numbness and tingling fingers 2' to Flu vaccine.  Remote thyroidectomy.  Remote L breast CA.  Remote appendectomy.  Remote knee bone spur removal.  Remote umbilical hernia repair.  Family hx of throat CA and breast CA.  Ex-smoker.  Demerol and Flu shot allergies.				Y	Y	5			U	10/08/2007	10/23/2007	15	CBC, CMP, Urine Macro and Micro, Hemogram, Sed. rate. Labs and Diagnostics:  CBC WNL. UA (+) for trace blood. CMP WNL. CK and CK-MB WNL. Cholesterol, LDL, and HDL all high. X-ray lumbar spine with L5-S1 disc space narrowing. Labs and Diagnostics(11/13/07 admission): Hgb 7.3, 8.2, 9.1.  EGD showing healing ulcer.  Erythematous esophagus. Diverticulosis seen on colonoscopy.  Flat polyps, not biopsied.	PVT	PVT	Aspirin; Flomax; Labetolol; Plavix; Synthroid; Zestril	None	Hypothyroidism; IBS; Coronary artery disease; (L) breast malignancy; Mastectomy 2004; HTN; Hyperlipidemia. PMH: L breast CA. HTN.  CAD s/p stent. BPH. Hypercholesterolemia. Hypothyroid s/p thyroidectomy. Arthritis.  Allergy to Demerol and unknown anesthesia.			1						1	Full blood count; Gastrointestinal haemorrhage; Metabolic function test; Myalgia; Red blood cell sedimentation rate; Urine analysis; Vasculitis	FLU3~SANOFI PASTEUR~U2442AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0297078	11/16/2007	OR	20.0	20		M	11/16/2007	pt received his meningitis, polio, influenza and Td vaccinations on the morning of 13 Oct 07. He reported no problems that day. On Sunday, he had his first PT without rolling or twisting his left ankle. He noted pain in his ankle when he tired to stand and he required assistance to return to room. When he got to his room, he noticed swelling on the outside of his left ankle and initially thought it was related to his PT earlier that day. He went to the emergency department in which he had a normal x-ray, and they tried to tap his ankle but did not get any fluid. Other than a low-grade fever, he denied any other symptoms. The swelling had decreased and on Monday morning, he was discharged with a posteror splint and non-weight bearing crutches. On the evening of the 15 he removed the wrap and splint and noticed that his entire foot and ankle was swollen, with decrease range of motion and discomfort. He did not notice swelling or discomfort during the day. He denied swelling above the level of his ankle. He returned to the emergency department Monday evening, in which he also noticed minimal swelling to his rt ankle and a small area of swelling on his rt knee. He was admitted and then on Tuesday morning he had developed spots on the top of his left foot only. He had no recall of fever or other symptoms. He was placed on vancomycin and soon afterwards began to develop redness, itching and hives on his upper body and scalp. The vancomycin was stopped and he was placed on steroids. He was discharged on Wednesday and has both dermatology and an allergy evaluation. The swelling quickly subsided within a couple of days and he was told he had a hypersensitivity immune reaction. Currently he has fully recovered without any residual effects. He has not returned to PT regime other than walking. He never had any problems like this in the past and stated he was a sprint runner during high school. He denies any problems with allergies or previous immunizations  01/14/2008 MR received for hospital DOS 10/15-17/2007 as well as F/u OVs as well as VHC eval 12/7/07. DX: Immune Hypersensitivity Reaction. Pt reported L foot swelling and pain.  Seen in ER and dxd with cellulitis.  Sx worsened despite abx and pt returned to ER 10/15/07 now with areas of erythema, warmth, and increased swelling and pain.  Allergic rxn to vanco in ER. Petechiae noted on feet as well as palmar erythema, and other areas of erythema and rash. R knee pain now noted. No response to abx, steroids started 10/16/07 with good response.  Resolution of sx by F/u 11/1/07.  Assessment: Dermatitis.					Y	3			Y	10/13/2007	10/14/2007	1	15 Oct 07: Final diagnosis: Skin left lower extremity Punch Biopsy-Unremarkable skin without significant histologic Abnormalities in multiple step sections Labs: 17 Oct 2007 complement CH50 54; C-Reactive Protein 3.2, (H); Streptolysin O Ab <20 IU/mL ; Albumin 3.4 g/dL (3.0-4.6); Calcium 8.5 mg/dL (8.0-10.8); Phosphate 4.2 mg/dL (2.5-5.0); Potassium 3.9 mEq/L (3.5-5.3); Sodium 141 mEq/L (135-150); Urea Nitrogen 8 mg/dL (5-22); Magnesium 2.5 mg/dL (1.6-2.6); Hemoglobin 13.1 (L) g/dL (13.5-17.5); Hematocrit 37.5 (L) % (41-53); WBC 4.7 x 10 (3) (4.5-11.0); RBC 4.06 (L) x 10 (6) (4.5-5.9); Platelets 159 x 10 (3) (150-400); Neutrophils 46.8% (34-66); Lymphocytes 36.5% (23-43); Monocytes 11.6 (H)% (0-5.2); Eosinophils 4.8 (H) % (0.2.7); Basophils 0.3% (0-0.5); Neutrophils 2.2 x 10 (3) (1.8-7.7); Lymphocytes 1.7 x10 (3) (1.0-4.8); Monocytes 0.5 x 10 (3) (0-0.8); Eosinophils 0.22 x 10(3) (0-0.45); Basophils 0.02 x 10(3) (0-0.2); ESR 10 mm/hr (0-15)   Labs and Diagnostics: CRP 4.9. CBC with WBCs 6.8. ESR 9.  Chem WNL.  Skin biopsy normal.	MIL	MIL	None	None	None PMH: none.  Now allergic to vancomycin			1						1	Arthralgia; Basophil count normal; Biopsy skin normal; Blood calcium normal; Blood magnesium normal; Blood phosphorus normal; Blood potassium normal; Blood sodium normal; Blood urea normal; C-reactive protein increased; Complement factor; Discomfort; Eosinophil count normal; Erythema; Gait disturbance; Haematocrit decreased; Haemoglobin decreased; Hypersensitivity; Joint range of motion decreased; Joint swelling; Lymphocyte count normal; Monocyte count increased; Neutrophil count normal; Petechiae; Platelet count normal; Pruritus; Pyrexia; Rash; Red blood cell count decreased; Red blood cell sedimentation rate normal; Streptococcal identification test; Swelling; Urticaria; White blood cell count normal	FLU3~SANOFI PASTEUR~AFLLA040AA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0125~1~UN~UN~POLIO VIRUS, INACT. (IPOL)~1|MNQ~SANOFI PASTEUR~U2382BA~1~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TD~SANOFI PASTEUR~U1958DA~1~UN~UN~TD ADSORBED (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0297080	11/16/2007	CA	16.0	16		M	11/09/2007	Patient complained of itchy, red, raised bumps over entire body except face 28 hr after Flu-Mist dose. Hives were relieved by single adult dose of Tylenol- Allergy medication but itchiness persisted x 1d until given 50mg. Benadryl. Patient denies any respiratory involvement. Hives recurred on 3rd and 4th day with decreasing intensity and released each time by 50mg. Benadryl. No incidence reported for days 5-10. No medical attention sought.									Y	10/30/2007	10/31/2007	1	none	OTH	PUB	None	none	none	None~ ()~~0.00~In Patient|NOne~ ()~~0.00~In Sibling		1						1	Erythema; Pruritus; Rash generalised; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500487P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0297081	11/16/2007	FL	1.3	1	.3	F	11/09/2007	Lymphadenopathy - neck									Y	11/02/2007	11/05/2007	3		PUB	PUB		URI - Om	none			1						1	Lymphadenopathy	DTAP~SANOFI PASTEUR~U2289CA~4~IM~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT2459NA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297082	11/16/2007	KS	8.0	8		M	11/07/2007	At the time of the vaccine there was reported a lot bleeding about 24 hrs after receiving the vaccine, the area seemed to small onset warmer that was still present at 98hrs				Y					Y	11/05/2007	11/06/2007	1	See attached;11/07/07: WBC 8.4; NEU% 46.4; MO% 9.3; LYM% 38.0; EOS% 5.5; BAS% 0.80; RBC 4.16; HGB 12.9; HCT 36.8; MCV 88; MCH H 31.1; MCHC 35.1; RDW L 10.8; PLT 249;11/08/07: PTT 27.7	PUB	PVT		none	none			1						1	Activated partial thromboplastin time normal; Basophil count decreased; Eosinophil percentage; Haematocrit normal; Haemoglobin normal; Haemorrhage; International normalised ratio; Lymphocyte percentage; Mean cell haemoglobin; Mean cell haemoglobin concentration; Mean cell volume normal; Monocyte percentage; Neutrophil percentage; Platelet count normal; Red blood cell count normal; Red cell distribution width decreased; Skin warm; White blood cell count	FLU3~SANOFI PASTEUR~U2438AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297083	11/16/2007	TN	72.0	72		F	11/09/2007	Right Arm turned red underneath running up toward the lymph nodes in the arm pit. Arm was sore									Y	10/16/2007	10/17/2007	1		OTH	PVT	Celebrex	No	Arthritis			1						1	Erythema; Pain in extremity	FLU3~SANOFI PASTEUR~U2493AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0980U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297084	11/16/2007	CT	1.3	1	.3	F	11/13/2007	Had febrile seizure on 11/11/07, was febrile following MMR vaccine admin. Also with rash to trunk				Y					Y	11/01/2007	11/11/2007	10		PVT	PUB		none	none			1						1	Febrile convulsion; Pyrexia; Rash	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B061BB~4~UN~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2460FA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1351U~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0297085	11/16/2007	KY	33.0	33		F	11/12/2007	Swelling of lips, tongue, throat and face, tightness in throat and chest, trouble swallowing and breathing and wheezing. Feeling dizzy and Faint, muscle aches and joint pain. rash and hives. fast pounding heart and chest pains				Y					U	10/31/2007	11/01/2007	1	EKG X2; Chest xray; Blood work	UNK	UNK						1						1	Arthralgia; Blood test; Chest X-ray; Chest discomfort; Chest pain; Dizziness; Dysphagia; Dyspnoea; Electrocardiogram; Lip swelling; Myalgia; Palpitations; Pharyngeal oedema; Rash; Swelling face; Swollen tongue; Throat tightness; Urticaria; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA026AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0297086	11/16/2007	KY	54.0	54		F	11/09/2007	Broke out in a rash; developed blisters on tongue and throat; rash and infection at injection site. I was put on antibiotics and allergy medicine for itching; Arm was sore; I developed flu like symptoms such as chills, low grade fever and joints hurting severely.				Y					Y	10/31/2007	10/31/2007	0		UNK	UNK						1						1	Arthralgia; Chills; Influenza like illness; Injection site infection; Injection site rash; Oral mucosal blistering; Pain in extremity; Pruritus; Pyrexia; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA026AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0297088	11/16/2007	MI	42.0	42		F	11/13/2007	Pain MRI 10/22/07, surgery 10/24/07 LETTER FROM PATIENT ATTACHED; I received a flu shot at pharmacy on Oct 2 2007, By the Pharmacist. The shot was given Very High in the left arm, I said that felt like you hit bone, she said well I would know if I hit bone. My arm was a little sore for a couple of days witch I expected is something Normal even in the past. I've gotten flu shots before no problem. But this hurt bad even after a few days and continue to get worse and worse I couldn't sleep and move my arm with out some great pain so my husband and I decided it was time to go to the doctor and see what he would say. I went to the Dr. on 10-18-07 he sent me for a M.R.I. on 10-22-07 Then sent me to a Orthopedic Specialist on 10-23-07 and the results were remove the and clear Liquid inside a bursa  and scope surgery on 10-24-07 at 430 pm.				Y					U	10/01/2007	10/01/2007	0		OTH	OTH	Unknown	Unknown	Unknown			1						1	Insomnia; Pain in extremity; Surgery	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA298A~2~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0297089	11/16/2007	MT	48.0	48		M	11/15/2007	Pericarditis: 4 days after vaccination classic symptoms/ EKG, positive rub on exam TX: anti-inflammatory.  11/27/07 Reviewed hospital ER medical records of 11/8/2007 which reveal patient experienced pleuritic chest pressure that increased when laying down, SOB, productive cough of clear sputum, indigestion, nausea, vomiting x 1 day.  Exam revealed (+) friction rub, abdominal tenderness.   Tx w/ASA & d/c home to f/u w/cardio in AM. FINAL DX: acute pericarditis.				Y					Y	11/06/2007	11/08/2007	2	LABS, EKG, CXR LABS: EKG revealed LVH & ST elevation suggesting pericarditis.  CRP 24.6 (H).  WBC 11.3 (H), neutros 77.2% (H), lymphs 12.3% (L).  D-Dimer 273 (H).  CXR WNL.	OTH	PUB			PMH: high cholesterol, GERD, hepatitis & jaundice resolved.			1						1	Electrocardiogram	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA064AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0297091	11/16/2007	WA	43.0	43		F	11/16/2007	After 45 minutes of receiving vax. symptoms were itching, shortness of breath, dizziness, light headed				Y					Y	10/31/2007	10/31/2007	0	None	OTH	UNK	Birth control.	none	none			1						1	Dizziness; Dyspnoea; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78995~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0297093	11/16/2007	MI	1.4	1	.4	M		Hives developed <24 hrs after Receiving Vaccine; Treated with Benadryl									U	11/07/2007	11/08/2007	1	none	PVT	PUB	Polytrim oph gtts.	Conjunctivitis				1						1	Urticaria	FLU3~SANOFI PASTEUR~UT2474BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297096	11/16/2007	MO	57.0	57		F	11/11/2007	Developed signs and symptoms of Brachial Plexus Neuritis: Intense burning pain my right shoulder and upper arm. This began spontaneously after I got up Sunday morning Oct 28th. 2 days later I developed intermittent parathesias in my right hand and upper arm. I consulted with Dr who referred me to a neurologist. I was treated with Prednisone.				Y					Y	10/26/2007	10/28/2007	2		PVT	UNK		NONE	NARCOLEPSY, HYPOTHYROIDISH; ALLERGIES: CODEINE, MORPHINE, SULFA			1						1	Musculoskeletal pain; Pain; Pain in extremity; Paraesthesia; Radiculitis brachial	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA323AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0297097	11/16/2007	WI	51.0	51		M	11/12/2007	DEVELOPED ERYTHEMA MULTIFORME 1 DAY AFTER GIVEN VACCINE				Y					U	11/04/2007	11/05/2007	1		OTH	OTH		None	None			1						1	Erythema multiforme	FLU3~SANOFI PASTEUR~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297098	11/16/2007	IA	66.0	66		F	11/13/2007	11/7 PC from client - reports fever of 101 deg F, chills, aches during night. Plans to see Dr. today - Reports just finished antibiotic; 11/6 - Back incision no Redness or drainage. P/C on 11/8 PC Reports has 6 Red area left arm at injection site. States Dr. -refilled antibiotics as questioning fever from post - back laser surgery; 11/3 - P/C - Redness Edema left arm gone - no further Fever, chills.				Y					Y	11/06/2007	11/07/2007	1		PUB	PUB		1 wk post back laser surgery	PCN			1						1	Chills; Injection site erythema; Oedema peripheral; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2511AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~08044~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0297100	11/16/2007	VA	33.0	33		F	11/12/2007	Onset 36hrs post vaccine - 103.8 Fever x 8hrs, lower grade fever x12 hrs. Muscle cramping, aches, headache, lethargic; Motrin x4, ice chips.									Y	11/08/2007	11/09/2007	1		PUB	PVT		NONE	Latex Sensitive, Allergy Levaquin, Morphine, Percocet			1						1	Headache; Lethargy; Muscle spasms; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80825~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0297101	11/16/2007	KY	68.0	68		F	11/13/2007	Patient complained of left arm and shoulder soreness on 10-29-07 and still complained of pain 11/13/07 Saw Dr. - was given Rx - Anti-inflammatory Patient was told should recover completely. Apt with Dr. Dec 3, 07 orthopedic				Y					U	10/26/2007	10/26/2007	0	none	PUB	UNK	HCTZ					1						1	Musculoskeletal pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2511AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297102	11/16/2007	AR				M		lower right sided abdominal pains that moved to trunk area then back within 4 days of receiving vaccine. Then rash appeared on waist on 10-27-07 and back pain that would awaken patient from sleep.									U	10/18/2007	10/19/2007	1		PVT	PVT	1	None Known	HX Reflux			1						1	Abdominal pain; Back pain; Rash; Sleep disorder	FLU3~SANOFI PASTEUR~U2436AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~0888U~1~UN~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0297103	11/16/2007	OH	59.0			F	11/13/2007	Patient received flu shot on 11/29/07. On 11/1/07 had headache. On 11/2/07 neck became red with hives. Call b Er Physician who told her to take benadryl 25mg q-4-6 hr. prn. Took it for 2 days. Hives resolved. Patient feet back to normal.									Y	10/29/2007	11/01/2007	3		PUB	PUB						1						1	Erythema; Headache; Urticaria	FLU3~SANOFI PASTEUR~U2527AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297104	11/16/2007	NV	79.0	79		M	11/11/2007	Pain and no range of motion in left arm.									U	10/11/2007	10/14/2007	3		UNK	UNK						1						1	Joint range of motion decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2463AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297105	11/16/2007	MI	74.0	74		M		allergic rash - small hives, bumps, head, face, chest, back.				Y					U	10/09/2007	10/13/2007	4		OTH	UNK	Ferazosin, Lipitor, finasteride					1						1	Dermatitis allergic; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA294EA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0297110	11/16/2007	WA				F		Severe - unremitting vertigo - However nausea, vomiting - fever - very next dry - This is by far the very worst vertigo I have ever bad!; To whom it may concern: Here is my form for a severe reaction to the flu shot. I might say I have had some slight vertigo over the years with definite deafness and tinnitis (genetic). I have probably been loosing my hearing since I was a child.........definitely since my late teens. I will be 54 years old as of December. My vertigo was never of this kind......it was very mild and stable. I don't ever, ever remember having nausea with this condition..........ever! The very next day, I woke up to some vertigo, I thought I would just get some thing to eat and it would go away. (I have always had a considerable degree of control over this.) However, it would not go away as the day wore on. It only got worse. I became nauseated, ran a fever and then vomited a couple of times. Normally with the flu........I would run a fever, throw up (no vertigo) and then get over it. Now everything seems to move at the slightest provocation. I often feel like I am walking on the wall. It is too dangerous to drive. This is a big, big change!! I am absolutely furious.....not to mention scared. I have talked with an ENT MD at my clinic. We both thought that the shot probably triggered a severe auto-immune reaction (I am a health-care professional also). I can't do anything. This comes at an extremely crucial time. I never had a flu shot before and I never will again......BIG-BIG MISTAKE!!!!									N	11/07/2007	11/08/2007	1		OTH	PUB			inner ear probs - dcaflues and timitas			1						1	Deafness; Nausea; Pyrexia; Tinnitus; Vertigo; Vomiting	FLU3~SANOFI PASTEUR~U2515AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297111	11/16/2007	NC	1.48	1	.5	M	11/06/2007	See attached copies;									Y	10/23/2007	10/23/2007	0		PVT	PUB	None	None	None			1						1	Abnormal behaviour; Asthenia; Body temperature increased; Crying; Disturbance in attention; Febrile convulsion; Feeling hot; Heart rate increased; Respiratory rate increased; Staring; Trance	FLU3~SANOFI PASTEUR~UT2474AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297113	11/16/2007	VA	52.0	52		F	11/12/2007	11/7/07 at 4pm vaccines administered. 11/8/07 patient calls reporting arm pain at IPV injection site. No redness/fever/swelling. Advised NSAID, cold compress. Calls later that day. in extreme pain. Advised -> ER. Refused. (spoke to- NP) 11/9/07 called patient at home in am. Trying to get in with her PCP. will call her if she can't to let us see her. -> over 11/9/07 at 5 pm I called patient later when I hadn't heard back from her. own PCP couldn't see her - she went to ER. X-rays/labs negative. Sent home on pain meds. No infection. Just woke up. I informed patient I would file VAERS report on pain seemed in excess of 'Normal' sxn..				Y					U	11/07/2007	11/08/2007	1	ER ran labs/X-ray	PVT	PVT	Estrogen patch. 0.025; Simvastatin, vitamins	none reported.	PCN allergy			1						1	Injection site pain; Laboratory test; X-ray	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78479~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~A0170~1~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|TYP~BERNA BIOTECH, LTD.~3001214~1~PO~MO~TYPHOID LIVE ORAL TY21A (VIVOTIF)~1	USA	Emergency room visit	Influenza
0297114	11/16/2007	VA	10.0	10		M	11/13/2007	Patient came to office x2 days after receiving vaccines with red, swollen area site approximately equal to 2-3 inches. Child was put on Augmentin, continue to do warm compress and to return if worsening									Y	11/06/2007	11/08/2007	2		PVT	PVT		None	Asthma			1						1	Injection site erythema; Injection site swelling	FLUN3~MEDIMMUNE VACCINES, INC.~U2462AA~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB207BA~1~UN~UN~HEP A (HAVRIX)~1	USA		Influenza
0297115	11/16/2007	NJ	38.0	38		F	11/08/2007	2:45 PM 11/8/07 FLUZONE VACCINE WAS GIVEN IN LEFT DELTOID, CLIENT FELT TINGLING ENTIRE INNER LEFT ARM FROM IM SITE TO ALL 5 FINGERS OF LEFT HAND.										11/08/2007	11/08/2007	0	B/P 104/76; P-68; R-8-Unlalored	OTH	UNK	ACIFEX	NO	MIGRAINE HA'S - STOMACH ULCER - LEVOQUIN Allergy			1						1	Blood pressure; Heart rate normal; Paraesthesia; Respiratory rate decreased	FLU3~SANOFI PASTEUR~U2478BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297116	11/16/2007	NC	6.0	6		F	11/10/2007	Redness/Swelling at injection site Large local reaction -8cm x 5cm				Y					U	11/08/2007	11/09/2007	1	none	PVT	PVT	none	None	none			1						1	Injection site erythema; Injection site swelling; Local reaction	FLU3~SANOFI PASTEUR~U2446AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297117	11/16/2007	CA	5.0	5		M	11/12/2007	Patient developed redness, swelling of his arm to the wrist. Experienced pain. Area warm to touch; Follow up in 2 to 3 days				Y					U	11/09/2007	11/10/2007	1		PVT	PVT	None	none	none	none prior~ ()~~0.00~In Patient|none prior~ ()~~0.00~In Sibling		1						1	Erythema; Oedema peripheral; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~U2478EA~4~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297118	11/16/2007	ND	70.0			U		Received flu shot - 20 minutes later developed itching and <dime sized wheal									Y					PVT	PVT		No	Vioxx			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~2509AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297119	11/16/2007	VA	0.4	0	.4	F	11/16/2007	No Adverse events. Child less than  6mos old received flu vaccine									U	11/08/2007				PVT	UNK	None	None	None			1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~UF2477EA~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297120	11/16/2007	PA	90.0	90		F	11/15/2007	Macular erythema  about 6 x 10cm. No hives									Y	11/14/2007	11/14/2007	0	None	PVT	PVT	None	No	HTN, Renal insuf, Elevated S. Ca.	None~ ()~~0.00~In Patient|None~ ()~~0.00~In Sibling		1						1	Erythema; Rash macular	FLU3~SANOFI PASTEUR~U2526AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1035F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297121	11/16/2007	GA	29.0	29		F	11/16/2007	Above injection site, Arm Red, warm. itchy, Felt like throat Needed clearing Voice Became raspy				Y					U	11/16/2007	11/16/2007	0		PVT	PVT	None	None	Asthma			1						1	Dysphonia; Injection site erythema; Injection site pruritus; Injection site warmth; Throat irritation	FLU3~SANOFI PASTEUR~U2439AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2767AA~UNK~IM~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0297122	11/16/2007	NY	15.0	15		M		15 x 15cm red warm browny area mostly under inj. site left deltoid. Advised to use ice pack and motrin prn									U	11/12/2007	11/14/2007	2	None	PVT	PVT	None	None				1						1	Injection site discolouration; Injection site erythema; Injection site warmth	FLUN3~MEDIMMUNE VACCINES, INC.~500492P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U2540AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0297123	11/16/2007	GA	40.0	40		F	11/16/2007	Approximatley five hours after injection eyes became very red and swollen. The developed facial swelling. Symptoms subsided with Benadryl and Patanol drops									Y	11/16/2007	11/16/2007	0		PVT	OTH	Celexia	None	Hypo thyroid			1						1	Eye swelling; Ocular hyperaemia; Swelling face	FLU3~SANOFI PASTEUR~U2436AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2492BA~1~UN~LA~TDAP (ADACEL)~1	USA		Influenza
0297126	11/16/2007	OH	70.0	70		M	11/16/2007	rash on torso; itching at injection site									U	11/14/2007	11/15/2007	1		OTH	PVT		None				1						1	Injection site pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA319BA~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0297127	11/16/2007	RI	30.0	30		F	11/16/2007	5-10 min. after the vaccination patient reported-light headed dizzy, Nausea, had patient seated with legs elevated and ice on back of neck, complaints persisted, Lost color in face and lip's, reported throat closing. placed patient on floor and elevated feet, proceeded with .3ml epi and 50mg benadryl cruet's arrived, o2 given				Y					Y	11/12/2007	11/12/2007	0		PUB	PUB		None				1						1	Dizziness; Nausea; Pallor; Throat tightness	FLU3~SANOFI PASTEUR~0253AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297128	11/16/2007	NC	40.0	40		F	11/17/2007	Received Flumist and 12 minutes later c/o facial flushing, red, throat felt strange. Rec'd Epipen and diphenhydramine				Y					Y	11/16/2007	11/16/2007	0		MIL	MIL	none	none	NKDA prior; History UNK			1						1	Erythema; Flushing; Throat irritation	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0297129	11/16/2007	RI	18.0			F	11/16/2007	received flu mist followed by hpv vaccine after 5 min. complaining of nausea and requested to lie down, upon standing patient collapsed, lots consciousness went into grand maul seizure lasting 1 min., second mild seizure after the first, regained consciousness				Y					Y				V.S 110/60; VS 120/60; No s/s of anaphylactic reaction	PUB	PUB		None	None			1						1	Grand mal convulsion; Loss of consciousness; Nausea; Syncope	FLUN3~MEDIMMUNE VACCINES, INC.~500490P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0929U~1~UN~LA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0297130	11/16/2007	RI	42.0	42		F	11/13/2007	Numbness in hands and fingers after injection of vaccine				Y					U	11/05/2007	11/05/2007	0		PUB	PUB						1						1	Hypoaesthesia	FLU3~SANOFI PASTEUR~U2493AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297131	11/16/2007	IL	57.0	57		F	11/14/2007	Swellowin at injection site, bleeding told to talk to MD									Y	11/14/2007	11/14/2007	0		OTH	PVT						1						1	Injection site haemorrhage; Injection site swelling	FLU3~SANOFI PASTEUR~U2511AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297132	11/16/2007	CA	50.0	50		M	11/16/2007	Patient c/o immediately of lightheadness after receiving injection. Site right deltoid became swollen and had hard lump. Lightheadness lasted about 5 mins. Wns able to stand without problems after 5 mins. No other problems were noted. Lump had decreased in size when client left the clinic. Instructed patient to let MD know about reaction. Called patient at 1250 pm and client was feeling good. 322 pm - still had swollen arm area on right deltoid. No other problems.									Y	11/16/2007	11/16/2007	0	None	PUB	PUB						1						1	Dizziness; Immediate post-injection reaction; Injection site induration; Injection site swelling	FLU3~SANOFI PASTEUR~U2509AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297135	11/16/2007	WI	82.0	82		F	11/16/2007	Had a follow-up appointment on 11/8/2007 patient reported an idiosyncratic reaction to the Influenza Fluviron vaccine. C/O persistent right shoulder/deltoid upper arm pain. Received a recent injury to arm, trauma, - Heavy lifting									N	10/09/2007	10/10/2007	1	9/12/07: Na+-139; K+. 3.9; Cl=107; CO2-23.7; glucose 98, BUN 65, Creatinine 2.5; GFR=20mL/minute; Albumin=3.6, TSAT=15%, PO4-3=4.1; Total Vitamin D 25-046	PVT	PVT	Synthroid, Cartia, Clonidone, Furosemide, Dialy vite, Hydralazine	None Patient very well, afebrile, MOX3				1						1	Blood albumin normal; Blood chloride increased; Blood creatinine increased; Blood glucose increased; Blood phosphorus normal; Blood potassium normal; Blood sodium normal; Blood urea increased; Carbon dioxide normal; Glomerular filtration rate abnormal; Musculoskeletal pain; Pain in extremity; Vitamin D	FLUX~UNKNOWN MANUFACTURER~78481~1~IN~NS~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0297136	11/16/2007	CO	5.0	5		M	11/14/2007	Redness and tenderness around vaccine site 1st noticed 2 d after vaccine									U	11/12/2007	11/14/2007	2	None	PVT	PVT	None	None	None			1						1	Injection site erythema; Injection site pain	DTAP~SANOFI PASTEUR~U22E9AA~5~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2512AA~4~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~20326~4~UN~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0182U~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0595U~2~IM~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0297137	11/16/2007	WI	57.0	57		F	11/16/2007	6pm - Dry cough with tickle in her throat swollen glands in her neck; 630pm - Eyes became bloodshot , swollen and itchy Breathing was shallow and rapid; 830pm - Developed headache and felt chilled; 200AM - Felt warm and eyes were draining and had nausea; 10AM - next day - complained of headache									Y	01/15/2007	11/15/2007	304	None - Did not seek medical care	PUB	PUB	None	Sinus problem afebrile	None	None~ ()~~0.00~In Patient|None~ ()~~0.00~In Sibling		1						1	Cough; Eye discharge; Eye pruritus; Eye swelling; Feeling of body temperature change; Headache; Hypoventilation; Lymphadenopathy; Nausea; Ocular hyperaemia; Respiratory rate increased; Throat irritation	FLU3~SANOFI PASTEUR~U2511AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297052	11/17/2007	NY	52.0	52		F	11/17/2007	patient give flu vaccine 11/13/07 in Medical clinic.presented to ER 11/17 for pain, swelling, redness left upper arm x 4 days. patient discharged home with motrin and benadryl po.				Y					U	11/13/2007	11/13/2007	0	none	UNK	UNK	metoprolol, vytorin, asa, calcium, tramadol	allergic rhinitis	HTN, Dyslipidemia, allergic rhinitis			1						1	Erythema; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~80061~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~UNKNOWN MANUFACTURER~td-160~UNK~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0297055	11/17/2007	AZ	3.0	3		F	11/17/2007	She had the flu shot at about 10:30am and by ab out 6:30 that evening she was coughing wheezing and seemed to be struggling to breath. I watched her and held her for a while but it didn't go away and then her coughing became uncontrollable. i checked her SATS because i kept an oxygen moniter in the house and they were in the 70's.  By about 9:30pm after consulting the doctor on call we took her to the hospital ER.  She was given high levels of oxygen and a steroid breathing treatment and then admitted into the PICU.  She had a chest xray that showed similar signs to pneumonia and she continued for the next 3 days to receive oxygen, breathing treatments and chest palpations until she could safely return home.  For another week after being discharged, she needed breathing treatments and lower levels of oxygen.  02/05/2008 MR received for DOS 11/3-5/2005 with D/C DX:  Presumed viral syndrome.  Bronchospasm. Pt presented to ER with 1 day hx of cough, increased RR, and increased work of breathing. On PE pt was tachypneic, in mild respiratory distress with nasal flaring and intercostal retractions. (+) coarse breath sounds with expiratory wheezing. Temp 39'C. O2 sats 82% on RA, up to 92% on 50% FiO2. Suctioning revealed thick, yellow secretions. Weaned off O2 on hospital day #2.  D/Cd on Xopenex nebs PRN.			Y	Y	Y	3			Y	11/05/2005	11/05/2005	0	chest xray showing signs of pneumonia. Labs and Diagnostics: Mycoplasma IgM (-).  BMP normal.  Viral DFA (-).  Viral respiratory cx (-).  Trach aspirate (+) for Pseudomonas.  CXR showed scoliosis and bilateral interstitial lung disease.  No focal infiltrates or pleural effusions noted.	UNK	UNK			she was born premature with mild chronic lung disease and a trach was placed at 10 mos. due to subglottic stenosis.  Her lungs had greatly improved by the time this vaccine was given.  PMH:  31 week premie with 12 week NICU stay, subglottic stenosis, trach at 10 months of age, Nissen NG tube placed at 10 weeks of age.  RSV 1/2004 on vent x 4 days.  Increased WOB and atelectasis 5/2005.  Pseudomonas in trach aspirate 6/2005.			1						1	Chest X-ray abnormal; Cough; Dyspnoea; Oxygen saturation decreased; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~1~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0297056	11/17/2007	PA	37.0	37		F	11/17/2007	Noticed body itching and hives/swelling on face day following injection. Hives and itching increased for 3 days following the shot. I am not allergic to eggs and have not had an adverse reaction to previous flu vaccines. At 3 day point, started following regimen of washing all over with benzoyl peroxide/sulfur cleanser, and layering benadryl gel, coal tar gel, calamine & zinc oxide, sulfur ointment on face to relieve the hives/swelling. This helped to alleviate the hives and swelling.									Y	11/13/2007	11/14/2007	1	NA	UNK	UNK	Wellbutrin SR 200 mg 2x per day, Lexapro 10 mg 1x per day	none	none	none~ ()~NULL~~In Patient|none~ ()~NULL~~In Sibling1		1						1	No reaction on previous exposure to drug; Pruritus generalised; Swelling face; Urticaria	FLUX~UNKNOWN MANUFACTURER~?~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0297059	11/18/2007	OH	32.0	38		F	11/18/2007	Flu vaccine was voluntarily given by my employer at my work site on Friday, November 16, 2007.  On Saturday, November 17, 2007 I awoke to a large red itchy swollen area at the site of the injection (upper left arm) about 7 in diameter.  My neck and chest were itchy as well.  I treated my symptoms by applying a topical allergy cream.  Sunday, November 18, 2007 I am still treating symptoms.									U	11/16/2007	11/17/2007	1		UNK	UNK	currently taking Effexor XR 225mg/day and Oxcarbazepine 450mg/day	No physical illness at time of vaccine.	Unless noted, allergic reactions include hives. ALLERGIES: (antibiotics) Pennisillian, Keflex, Erythromianin, Levaquin, Bactrim, Biaxcin, (could be others in this category), Depakote (hair loss), Lithium (tremors), Lexapro, Wellbutrin, and Tree pollen, Peas, and Animal dander.			1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Pruritus	FLUX~UNKNOWN MANUFACTURER~unknown~3~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0297060	11/18/2007	IL	28.0	28		F	11/18/2007	Sore/achy muscles around elbow joint in same arm (left), which is NOT the patient's dominant arm. No apparent other causes of this joint discomfort. Notably, the location of the shot is still very tender and has been since the shot was administered.									N	11/15/2007	11/17/2007	2		PUB	UNK		no.	4 mos. pregnant			1						1	Arthralgia; Injection site pain; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0295802	11/19/2007	IA	56.0	56		F	11/15/2007	Initial report received from a health care professional on 06 November 2007. A 56-year-old female with history of glucose intolerance, high cholesterol and allergies to codeine and sulfa had received a left deltoid, intramuscular injection of Fluzone SV 2007-2008 (lot number U2511AA) on 01 November 2007 at 08:10 hours and at approximately 19:00 hours, she developed sore arm and chills. Convulsions began at 21:00 hours and the patient was taken to the hospital via ambulance. The patient reported that results of bloodwork and CT head scan were normal. The patient was released at approximately 01:30 hours and was instructed not to receive flu vaccinations in the future. No additional information had been provided at the time of this report.				Y					Y	11/01/2007	11/01/2007	0	Patient reported that the results of a CT head scan and bloodwork were normal.	OTH	OTH	VYTORIN; METFORMIN		The patient had a history of high cholesterol, glucose intolerance and allergies to codeine and sulfa. Concomitant medications: Vytorin and metformin. The patient had no illness at the time of vaccination. In response to the question asking if the patient or brother/sister experienced an adverse event following prior vaccination, it was reported that there was a possible reaction (not specified) in the patient's grandmother.		200703749	1						2	Blood test; Chills; Computerised tomogram; Convulsion; Pain in extremity; Blood test normal; Chills; Computerised tomogram normal; Convulsion; Pain in extremity	FLU3~SANOFI PASTEUR~U2511AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2511AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0297108	11/19/2007	TX	43.0	43		F	11/19/2007	Dr.  used these terms: brachial plexitis or acute brachial neuritis and Parsonage-Turner Syndrome. Literature on both seem to totally match up with my experience. I got my shot on Thursday, October 18. In the next hours the pain spread down my arm, worsened, and then by 1am th next morning, was severe. I went to the ER - had x-rays, blood work, given pain pills. It was predicted to lessen in a week. However, the pain persisted and made me unable to sleep, even with the pain pills. Additionally, my right pointer finger went totally numb. So after a week, I saw my PCP. He said there was nerve damage, and he wanted me to totally rest my arm in a sling to let the nerves start to heal and assess in a week more. At the next week's appointment, I was not better and he referred me to the neurologist, Dr., who I saw the next day (November 2.) He quickly diagnosed it. He said the brachial plexus was very inflamed, causing the pain and damage. He described it as a fairly rare auto-immune reaction to the flu shot that required an immediate high dose of steriods, physical therapy to maintain mobility and strength and monitoring. A nerve mapping is scheduled for November 28. He said that some of the damage may be permanent. He said the present goal was to work through the pain, avoiding further complications of guarding a painul area, a potential of something he called RSD. I started a course of physical therapy at Rehab yesterday, November 12. 11/30/07 Reviewed medical records from neurologist which reveal patient experienced pain & sensory change in RUE x approx 3 weeks.  Initially injection site had a tender bump & then pain traveled downward to distal aspect of RUE & had intractable pain & sensory loss of right index finger since then.  Difficulty sleeping due to pain.  Had received previous flu shots w/o problems.  Had been seen in ER on 10/21.  CBC, chemistry & shoulder x-ray WNL.  Exam revealed stiff tender c-spine musculature; tenderness of right axilla; abduction & extension of right shoulder caused pain; & entire RUE was dusky in dependency.  RUE musculature was weak w/reduced sensation of right index finger.  Reduced RUE reflexes.  Tx w/steroid tapering dose.  Referred for CXR & EMG/NCS, PT/OT.   FINAL DX: post vaccination right brachial plexitis, presumably with an autoimmune mechanism.				Y					N	10/18/2007	10/18/2007	0	Patient saw 3 doctors, ER, PCP, and Neurologist. At ER had x-rays and blood work done. Started physical therapy at Rehab.   Neurologist diagnosis:  brachial plexitis or Parsonage-Turner syndrome. LABS: CXR WNL.  EMG/NCS abnormal suggesting mild resolving denervation process of RUE c/w convalescent stages of brachial neuritis.	UNK	UNK		none	none PMH: chronic seasonal allergies, previous anaphylaxis reactions, IBS.			1						1	Blood test; Hypoaesthesia; Immunisation reaction; Insomnia; Nerve injury; Neuralgic amyotrophy; Pain in extremity; Radiculitis brachial; X-ray	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80062~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0297165	11/19/2007	MO	55.0	55		F	11/19/2007	Received shots on Monday, Nov 5, 2007.  Became sick on Tuesday afternoon with fever, chills, and body aches.  Left work early on Tuesday, came to work on Wednesday and went home sick that morning. Returned to work on Thursday, better, but feeling a little sluggish.									Y	11/05/2007	11/06/2007	1		PVT	PVT		None, yearly exam				1						1	Chills; Pain; Pyrexia; Sluggishness	FLU3~SANOFI PASTEUR~02488AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0963U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297166	11/19/2007	NJ	42.0	42		F	11/19/2007	Patient received Flu shot 11/15/07,came back to office 11/16/07 injection site ed,swolle,hot to the touch. Given Keflex 500mg.BID for 10 days and Benadryl-OTC.PRN.									U	11/15/2007	11/16/2007	1	N/A	PVT	UNK			Hyperlipidemia,DDD,GERD,Migraines, NKDA			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2505AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297167	11/19/2007	NY	0.33	0	.5	M	11/19/2007	Developed itchy rash day after vaccines given.  Started on back and now spread to entire body. On exam on 11/19/07, noted to have s/s erythema multiforme.  Multiple lesions over entire body.									U	11/13/2007	11/14/2007	1	none	PVT	PUB		None	None			1						1	Erythema multiforme; Rash generalised; Rash pruritic	DPP~NOVARTIS VACCINES AND DIAGNOSTICS~ac21bo90aa~2~IM~LL~DIPHTHERIA TOXOID + PERTUSSIS + IPV (QUATRO VIRELON)~1|FLU3~SANOFI PASTEUR~u2461ca~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBPV~PFIZER\WYETH~uf112aa~2~IM~RL~HIB POLYSACCHARIDE (HIBIMUNE)~1|PNC~PFIZER\WYETH~ab53895a~2~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0297168	11/19/2007	NY	90.0	90		M	11/19/2007	Received pneumovax injection in left thigh on 10/29/07.  Several hours later complained of pain at injection site.  Had redness at injection site. No swelling. Had pain severe enough that patient was unable to ambulate on leg for 48 hours.  Patient on medications for pain prior to this incident.  Patients primary MD consulted (and saw patient)and ordered site to be intermittently iced.  Pain and inability to ambulate resolved within 48 hours.  This information was reported to Certified Home Care Agency providing vaccine 22 days after incident occured.				Y					Y	10/29/2007	10/29/2007	0	None	UNK	UNK		None	Allergy- Sulfa, Dx: dementia, chronic pain from shingles			1						1	Abasia; Injection site erythema; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78478~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~05550~2~IM~LL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0297169	11/19/2007	GA	58.0	58		F	11/19/2007	Pt. received Fluzone and Pneunovax on 11/16/07 both in Left Deltoid due to previous Right Mastectomy.  Approximately 5 AM on 11/17/07 Patient noted edema, increased warmth, pain, and redness to Left Deltoid, along with malaise, stiffening of elbow and shoulder joints and fever.  This continued throughout 11/17/07 and 11/18/07.  Patient presented to Health Dept today for evaluation of area.  Erythma extends to an area approx. 10cm X 15cm on L upper arm, with warmth and redness noted to area.  Patient states she feels slightly better today, and was instructed to take OTC Tylenol as needed for pain and/or fever, and to apply a thin layer of neosporin to area and cover with warm compresses to help decrease pain/edema.									U	11/16/2007	11/17/2007	1	None	PUB	PVT	Prilosec OTC daily	None	History of Breast CA to Rt Breast in 12/2000 with Mastectomy	None~ ()~NULL~~In Patient|None~ ()~NULL~~In Sibling1		1						1	Erythema; Joint stiffness; Malaise; Oedema; Pain in extremity; Pyrexia; Skin warm	FLU3~SANOFI PASTEUR~U2524AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0090U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297170	11/19/2007	IA	36.0	36		F	11/19/2007	Developed swelling in L knee on 10-16-07. Felt tight, no pain. Developed swelling in both knees 11-17-07. On 11-18-07 swelling went to hands, ankles, wrists. Also developed pain on 11-18-07 in all joints. Has appointment with doctor in afternoon of 11-19-07. Has taken Advil sporatically when developed pain.									U	11/07/2007	11/16/2007	9		UNK	PUB	Unknown	None	Unknown	Flu-like symptoms~Influenza (Seasonal) (no brand name)~1~32.80~In Patient		1						1	Arthralgia; Joint stiffness; Joint swelling; Oedema peripheral; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80957~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0297171	11/19/2007	MO	76.0	76		F	11/02/2007	Unable to get a hold of patient until 11/05/07.  Patient received flu vaccine 11/01/07, reports during that night she felt like she might of ran a fever (some sweating, never took temp)  When she awoke the next morning, she noticed a large walnut size lump under left jaw and small one under right jaw, not sore to the touch, or sore throat or any other adverse effects.  11/05/07 reports lumps almost gone.  Instructed to see HCP.				Y					Y	11/01/2007	11/02/2007	1		UNK	UNK	aspirin	none	none		MO200735	1						1	Hyperhidrosis; Pyrexia; Skin nodule	FLU3~SANOFI PASTEUR~U2442AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297176	11/19/2007	MO	6.0	6		M	11/07/2007	11/07/07 Mother called stating child has large red swollen area to left deltoid at site of hep A #2 vaccination he received on 11/01/07.  She had been out of town since last friday so she did not know when reaction started.  Child was with father.  Instructed to apply warm moist packs on 20 minutes off.  She might give Benadryl for age, instructed to contact her family doctor.  11/14/07 Mother called states child saw family Dr.  Topical ointment applied and ordered Benedryl and Ibuprophen.				Y						11/01/2007	11/07/2007	6		UNK	UNK		No Known	PCN. Cephalasporins. Macrolide Antibiotics	Elevated Temp~DTaP (Infanrix)~~0.50~In Patient	MO200737	1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2457AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB211AA~2~IM~LA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0297181	11/19/2007	CO	31.0	30		F	11/19/2007	10-16-07: Received vaccination.  10-18-2007:  Woke up and felt aches in legs, arms, and back.  Experienced general malaise and lethargy.  Symptoms were more pronounced upon awakening.  No fever or chills.  Took intermittent ibuprofen 400 mg once to twice daily.  10-27-07:  Symptoms resolved.									Y	10/16/2007	10/18/2007	2	none	PUB	PUB	none	none	NKDA, no medical conditions			1						1	Lethargy; Malaise; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA280DA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0297185	11/19/2007	WA	11.0	11		F	11/19/2007	ON 10/29, HPV, VARICELLA, AND FLU ADMINISTERED; 11/01 PARENT/PT RTC WITH CELLULITIS AT IMMUNIZATION SITE.  PT TREATED EMPIRICALLY BY SAME PROVIDER WITH COURSE OF KEFLEX. PT MEDICALLY EXCUSED FROM SCHOOL X 2DAYS.									Y	10/29/2007	11/01/2007	3	NONE	PUB	PUB	NONE.	NONE.	NONE.			1						1	Injection site cellulitis	FLU3~SANOFI PASTEUR~U2498AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0930U~2~IM~LA~HPV (GARDASIL)~1|VARCEL~MERCK & CO. INC.~1024U~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0297187	11/19/2007	WA	13.0	13		M	11/19/2007	ON 10/29, FLU, VARICELLA ADMINISTERED, PT LEFT IN GOOD CONDITION; ON 11/01, PT RTC WITH CELLULITIS AT IMMUNIZATION SITE. PT TREATED EMPIRICALLY WITH COURSE OF KEFLEX. PT MEDICALLY EXCUSED FROM SCHOOL FOR 2 DAYS.									Y	10/30/2007	11/01/2007	2	NONE.	PUB	PUB	METHYLPHENIDATE	NONE	314.01			1						1	Injection site cellulitis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~U2468AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|VARCEL~MERCK & CO. INC.~1024U~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0297188	11/19/2007	CO	2.0	2	.9	M	11/19/2007	Developed serum sickness 1-2 days after vaccination.  Pt had received the influenza vaccine once prior last year.  He developed urticaria, hives, erythema multiforme type lesions, no mucosal lesions, diffuse swelling and tenderness of all joints				Y					U	11/14/2007	11/15/2007	1	nl cbc, esr 16, c3/c4 pending, ua with minimal proteinuria	MIL	MIL	none	none	reactive airways disease, speech delay			1						1	Arthralgia; Complement factor C3; Complement factor C4; Erythema multiforme; Full blood count normal; Joint swelling; Proteinuria; Red blood cell sedimentation rate increased; Serum sickness; Urine analysis abnormal; Urticaria	FLU3~SANOFI PASTEUR~UT2459KA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297189	11/19/2007	GA	12.0	12		M	11/19/2007	Seen in clinic for flu vaccination and was given adult flu vaccine (flulaval) 0.5ml									Y	11/17/2007				MIL	UNK		none				1						1	Medication error; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA042AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0297190	11/19/2007	WA	8.0	8		F	11/19/2007	ON 10/29, FLU AND VARICELLA ADMINISTERED, PT LEFT IN GOOD CONDITION; 0N 11/2, PT RTC WITH CELLULITIS AT VARICELLA IMMUNIZATION SITE. PT TREATED EMPIRICALLY WITH COURSE OF KEFLEX, AND MEDICALLY EXCUSED FROM SCHOOL FOR 2 DAYS.									Y	10/29/2007	11/02/2007	4		PUB	PUB	XANAX	NONE	299.0			1						1	Injection site cellulitis	FLU3~SANOFI PASTEUR~U2468AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0800U~1~IM~LA~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~1024U~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0297194	11/19/2007	GA	12.0	12		F	11/19/2007	seen in cliinic for flu vaccination and was given adult flu vaccine (flulaval) 0.5ml									Y	11/17/2007			n/a	MIL	UNK		none				1						1	Medication error; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~LFLLA042AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0297195	11/19/2007	CT	46.0	46		F	11/16/2007	aprx 2 1/2 hrs later, slight cough turned into, weezing and breathing difficulty. It lasted about 6hrs. I thought I was getting sick, so went to bed early. When I woke following am, I felt better and realized it was an allergy attack.  That kind of attack only happens to me when I visit a friend who has a cat.									Y	11/07/2007	11/07/2007	0		UNK	UNK	none					1						1	Allergy to animal; Cough; Dyspnoea; Wheezing	FLUX~UNKNOWN MANUFACTURER~affla082aa~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0297196	11/19/2007	NY	41.0	44		M	11/19/2007	Flu Mist vaccine given 10 days after smallpox vaccine given.									Y	11/13/2007	11/19/2007	6	None	MIL	MIL	None	None	None			1						1	Inappropriate schedule of drug administration; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~500477P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0297198	11/19/2007	SC	3.0	3		M	11/19/2007	seen in clinic for flu vaccination and was given adult flu vaccine (flulaval) 0.5ml									Y	11/17/2007			n/a	MIL	UNK		none				1						1	Medication error; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~LFLLA042AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0297199	11/19/2007	CO	58.0	58		F	11/19/2007	11-2-07:  Received pneumovax and influenza vaccinations in the morning.  In the evening patient's arm was swollen and warm.  11-3-07:  Developed localized hives (about 15-20) in right arm near injection site.  Also had a headache upon awakening and arm pain.  Pt took 800 mg of ibuprofen for headache and pain.  Pt's pain decreased however headache remained so pt took Axert.  11-4-07:  Hives stopped but pt still had redness and swelling down arm.  11-5-07:  Pt still had headache and upper arm showed some warmth and swelling but did improve.  Pt went to see PCP on this day and PCP advised to apply heat or cold pack and to take benadryl and ibuprofen for symptom control.  11-6-07:  Pt felt better on this day.				Y					Y	11/02/2007	11/02/2007	0	none	PUB	PVT	Axert, Zoloft, Lamictal, Trileptal, Klonopin, Norvasc, Levoxyl, Abilify, Ibuprofen, ASA, Calcium, Vitamin D, multivitamin	none	Allergies:  chloroquine (itching), sulfa (itching, SOB).  Medical Conditions:  HTN, bipolar, hypothyroidism, depression, sleep apnea			1						1	Erythema; Headache; Oedema peripheral; Pain in extremity; Skin warm; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA280DA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0804U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0297200	11/19/2007	SC	3.0	3		M	11/19/2007	seen in clinic for flu vaccination and was given adult flu vaccine (flulaval) 0.5ml									Y	11/17/2007			n/a	MIL	UNK		none				1						1	Medication error; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~LFLLA042AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0297201	11/19/2007	SC	5.0	5		M	11/19/2007	seen in clinic for flu vaccination and was given adult flu vaccine (flulaval) 0.5ml									Y	11/17/2007			n/a	MIL	UNK		none				1						1	Medication error; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~LFLLA042AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0297202	11/19/2007	GA	4.0	4		M	11/19/2007	seen in clinic for flu vaccination and was given adult flu vaccine (flulaval) 0.5ml									Y	11/17/2007			n/a	MIL	UNK		none				1						1	Medication error; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~LFLLA042AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0297203	11/19/2007	GA	3.0	3		M	11/19/2007	seen in clinic for flu vaccination and was given adult flu vaccine (flulaval) 0.5ml									Y	11/17/2007			n/a	MIL	UNK		none				1						1	Inappropriate schedule of drug administration; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~LFLLA042AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0297204	11/19/2007	NY	19.0	19		M	11/19/2007	Flu mist given 13 days after smallpox vaccine administered.									Y	11/17/2007	11/17/2007	0	None	MIL	MIL	None	None	None			1						1	Inappropriate schedule of drug administration; Medication error	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~500477P~1~IN~NS~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0297205	11/19/2007	MD	48.0	48		F	11/19/2007	10 minutes after receiving vaccination, patient complained of feeling very tired and weak.  Blood pressure elevated at 165/95.  Patient referred to primary care doctor for blood pressure management									U	11/19/2007	11/19/2007	0	BP Elevated	MIL	MIL	Hydrocholorthiazide	None	Hypertension			1						1	Asthenia; Blood pressure increased; Fatigue	FLUN3~MEDIMMUNE VACCINES, INC.~500491P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0297206	11/19/2007	NC	4.0	4		F	11/19/2007	On October 28th my husband returned home where my daughters were being cared for by their grandparents.  We noticed small bruises on her legs and swelling in her ankles we took her to the ER where they said it was an injury.  I took her to her pediatrician the following day and found out she had Henoch-Schonlein Purpura (HSP).  This occurred approximately a week after she received her flu mist.  Her flu mist was administered on October 19, 2007.  It is difficult to know if the symptoms occurred earlier because my husband and I were out of town for the weekend and she was in the care of her grandparents.  She has received the flu shot before know as Flu Zone.  She had the flu shot in 2003,2004,2005, and 2006.  This was the first year she received the flu mist. 12/10/07-records received for DOS 10/28/07-DX: ankle contusion. See in ED bruising on ankles. 12/26/07-office note 11/14/07-well visit.				Y					U	10/19/2007	10/28/2007	9	the doctor ran a CBC as well as a urinalysis.	UNK	UNK	N/A	N/A	N/A			1						1	Contusion; Full blood count; Henoch-Schonlein purpura; Joint swelling; Urine analysis	FLUN3~MEDIMMUNE VACCINES, INC.~500487P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0297207	11/19/2007	GA	10.0	10		F	11/19/2007	seen in clinic for flu vaccination and was given adult flu vaccine (flulaval) 0.5ml									Y	11/17/2007			n/a	MIL	UNK		none				1						1	Medication error; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~LFLLA042AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0297208	11/19/2007	GA	9.0	9		M	11/19/2007	seen in clinic for flu vaccination and was given adult flu vaccine (flulaval) 0.5ml									Y	11/17/2007			n/a	MIL	UNK		none				1						1	Medication error; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~LFLLA042AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0297209	11/19/2007	GA	15.0	15		M	11/19/2007	seen in clinic for flu vaccination and was given adult flu vaccine (flulaval) 0.5ml									Y	11/17/2007			n/a	MIL	UNK		none				1						1	Medication error; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~LFLLA042AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0297210	11/19/2007	SC	2.0	2	.2	M	11/19/2007	seen in clinic for flu vaccination and was given adult flu vaccine (flulaval) 0.5ml									Y	11/17/2007			n/a	MIL	UNK		none				1						1	Medication error; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~LFLLA042AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0297211	11/19/2007	CO	75.0	75		F	11/19/2007	11-6-07:  Vaccine administered and pt felt fine on this day.  11-7-07:  Pt had headache all day, aches all over body, felt very fatigued, was nauseated, couldn't move, and felt like passing out due to dizziness.  No fever or chills.  Pt took tylenol every evening unti felt better.  11-14-07:  Pt started to feel better.									Y	11/06/2007	11/07/2007	1	None	PUB	PVT	labetolol, premarin, estratest, synthroid, tegratol, lisinopril, felodipine, bumetanide, effexor, prilosec	none	Allergies:  sulfa, ceclor, dilantin, clonidine, amoxicilllin, HCTZ.  Medical Conditions:  HTN, hypothyroidism, epilepsy			1						1	Decreased activity; Dizziness; Fatigue; Headache; Nausea; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA280DA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0297212	11/19/2007	NY	23.0	23		M	11/19/2007	Two live vaccines given 14 days apart.  No adverse reaction or treatment sought									Y	11/17/2007			None	MIL	MIL	None	None	None			1						1	Inappropriate schedule of drug administration; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~500477P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0297213	11/19/2007	AR	40.0	40		U	11/19/2007	Immediate itching at site of injection, generalized pruritis, Headache, nauseated, shakey, sensation, rash surrounding site of injection, erythematous, very fine papules.  BP elevated--142/96, heart pounding.				Y					U	11/02/2007	11/02/2007	0	BP and pulse monitored, remained 140's systolic, low 90's diastolic.	UNK	PUB		none	none			1						1	Blood pressure increased; Headache; Immediate post-injection reaction; Injection site pruritus; Injection site rash; Nausea; Palpitations; Pruritus generalised; Rash erythematous; Rash papular; Tremor	FLU3~SANOFI PASTEUR~U 2469AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297214	11/19/2007	NY	19.0	19		M	11/19/2007	Received smallpox on 11/3/07 and received flumist on 11/18/07									Y	11/18/2007	11/19/2007	1	None	MIL	MIL	None	None				1						1	Inappropriate schedule of drug administration; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~500477P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0297215	11/19/2007	NY	43.0	43		M	11/19/2007	Smallpox given on 11/3/07, Flumist given on 11/15/07									Y	11/15/2007	11/19/2007	4		MIL	MIL	None	None	None			1						1	Inappropriate schedule of drug administration; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~500477P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0297216	11/19/2007	NY	41.0	41		M	11/19/2007	Two live vaccines given two weeks apart. No adverse reaction or treatment given.									Y	11/17/2007			None	MIL	MIL	None	None	None			1						1	Inappropriate schedule of drug administration; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~500477P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0297217	11/19/2007	WI	15.0	15		F	11/19/2007	Shaking of left arm with pain- ER evaluation was muscle tightening treat with heat and ibuprofen.				Y					Y	11/13/2007	11/14/2007	1	none	UNK	UNK	none	early S/S of common cold and sore throat but afebrile at time of vaccination	speech and language deficits			1						1	Muscle tightness; Pain in extremity; Tremor	FLU3~SANOFI PASTEUR~U2438AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2328AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~0825U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0297220	11/19/2007	CO	47.0	47		F	11/19/2007	10-30-07:  Vaccine given.  11-05-07:  Had severe lower back pain radiating to the hips.  Also had bloating in the abdomen.  11-06-07:  Went to ER and had CBC and kidney function tests taken.  All tests were normal.  Received vicodin and norflex in the ER but only took one dose due to nausea.  11-7-07:  Went to PCP.  Pt has been taking ibuprofen to help combat symptoms all this time.  11-8-07:  MRI was obtained and revealed L2 edema of unknown reason.  Also on this day the pt's legs felt weak and still had back pain.  11-14-07:  Ultrasound of the abdomen was taken and was unremarkable.  11-15-07:  Pt started to feel better.				Y					Y	10/30/2007	11/05/2007	6	11-6-07:  CBC and kidney function tests were obtained and both normal.  11-8-07:  MRI of lower spine revealed L2 edema of unknown reason.  11-14-07:  Ultra sound of abdomen was obtained and unremarkable.	PUB	PUB	Synthroid, Norflex, Vicoden, IBU	None	Allergies:  amoxicillin (rash)  Medical Conditions:  hypothyroidism			1						1	Abdominal distension; Arthralgia; Back pain; Full blood count normal; Muscular weakness; Nausea; Nuclear magnetic resonance imaging abnormal; Renal function test normal; Ultrasound abdomen normal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA280DA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0297221	11/19/2007	CO	0.75	0	.7	M	11/19/2007	None at time of injection									U	11/19/2007				PVT	UNK						1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2479AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297223	11/19/2007	WA	70.0	70		F	11/19/2007	angioedema (swollen lips and tongue) vaccine 10/20 1130 am Symptoms began 10/22 5pm no labs done . sent home with benadryl				Y					Y	10/20/2007	10/23/2007	3	none	UNK	PVT	lisinopril for years,paxil,flexaril,aspirin,fish oil, aspirin, vitamins, melatonin, other supplements	none	sulfa rash			1						1	Angioedema; Lip swelling; Swollen tongue	FLU3~SANOFI PASTEUR~u2453aa~7+~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~0884u~2~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0297241	11/19/2007	TX	8.0	8		M	11/15/2007	Initial report received on 05 November 2007 from a health care provider. An eight-year-old male patient, with no illness at the time of vaccination, had received a right arm, intramuscular injection of Fluzone SV 2007-2008, lot number U2499AA, on 03 November 2007. Within 24 hours post-vaccination, the patient experienced erythema, pain, blisters, and a feeling of hot. The affected area was from the top of the arm to below the elbow. The specific arm affected was not reported. The patient was subsequently diagnosed with cellulitis and admitted to the hospital for 24 hours. Treatment included vancomycin and steroids. Per the reporter, the events had almost resolved.					Y	0			N	11/03/2007	11/04/2007	1		UNK	UNK			The patient had received influenza vaccine five years prior with no adverse event. He had a history of allergy to omnicef and tubes in ears.		200703738	1						1	Blister; Cellulitis; Erythema; Feeling hot; Pain	FLU3~SANOFI PASTEUR~U2499AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0297242	11/19/2007					U	11/15/2007	Initial report received on 05 November 2007. An unidentified patient (age not reported; gender unknown) developed Attention Deficit Disorder (ADD), nervous tics and hearing disturbances (onset dates unknown) after receiving a Fluzone vaccination in December 2006 (lot number and route/site of administration unknown). Patient outcome was not reported. No additional information was provided at the time of this report. The reporter, who identified herself only by first name, refused to provided contact information concerning the facility that administered the vaccine. Follow-up information, therefore, cannot be requested at this time. The reporter indicated that she would call back.				Y					U	12/01/2006				OTH	OTH			It was reported to be unknown if the patient had any illness at the time of vaccination, unknown if the patient had pre-existing allergies or medical conditions, unknown if the patient received any other vaccinations within four weeks prior to the Fluzone vaccine, unknown if the patient was taking any other medications and unknown if the patient had experienced adverse events following prior vaccinations.		200703742	1						1	Attention deficit/hyperactivity disorder; Hearing impaired; Tic	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297245	11/19/2007	MT	41.0	41		F	11/14/2007	Itching, coughing, hives, SOB, redness over influenza injection site, Benadryl IV, Solumedrol IV, Epinephrine, Pepcid IV, MS IV. Toprol.  12/04/2007 MR received for DOS 11/14-16/2007 with D/C Dx: Anaphylactic reaction to Influenza A immunization. Chest pain, etiology uncertain, possibly related to the reaction.  Post-menopausal.   Pt presented to ER with a reaction to the flu shot which consisted of  throat irritation, cough, urticaria, swelling, itching and respiratory compromise. Treated with epi, Benadryl, steroids and O2 with gradual improvement.  However, pt developed L-side chest pressure and pain which was not responsive to morphine.  Admitted to ICU for observation and eval. Pt had several recurrances during hospital stay. Improvement noted with Labetalol and po beta-blockers.				Y	Y	3			Y	11/14/2007	11/14/2007	0	Labs and Diagnsotics:  EKG with non-specific changes, later WNL per MD. CMP WNL except glucose of 149. Initial CBC WNL with WBC up to 11.1 on 11/16/07. Cardiac enzymes WNL.  D-dimer WNL. UA WNL. CT chest normal.	PVT	PVT	Estrogen; Paroxetine; Proviqil; Vitamins; ASA; Glucosamine	None	Sulfa; Codeine; Levaquin; PCN; Tetracycline. PMH:  endometriosis with multiple surgeries, bilateral patellofemoral syndrome with R knee arthroscopy, fx L ankle.  Allergies:  Sulfa, codeine, Levaquin, PCN, Tetracycline.			1						1	Cough; Dyspnoea; Injection site erythema; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2476GA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2689AA~4~IM~RA~TDAP (ADACEL)~1	USA	Hospitalisation	Influenza
0297246	11/19/2007	MT	55.0	55		F	11/15/2007	Coughing, chest tightness, tachycardia within 3-5 min. of injection. Rec'd 25 mg Benadryl + 125mg solu Medrol with resolution of symptoms				Y					Y	11/15/2007	11/15/2007	0	None	PUB	PVT	MVI, Vit. C	None	PCN, Iodine			1						1	Chest discomfort; Cough; Immediate post-injection reaction; Tachycardia	FLU3~SANOFI PASTEUR~U2476GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297247	11/19/2007	MD	1.0	1	.0	F	11/16/2007	40 minute afebrile seizure about 11 hrs after receiving vaccines.  11/30/2007 MR received ER visit 11/10/2007 with DX:  Likely Febrile Seizure.  Infant developed fever on the pm of vax.  Pt was witnessed to fall, become unresponsive, foam at the mouth, and vomit.  Pt had L sided shaking of L arm and leg lasting ~40 minutes.   PE (+) for coarse lung sounds with bilateral rhonchi, otherwise WNL. Pt d/cd home to F/U as outpatient.				Y	Y	1			Y	11/09/2007	11/09/2007	0	see attached. Labs and Diagnostics:  Head CT unremarkable.  CXR WNL. EKG shows sinus tachycardia. Tox screen (-) except for benzodiapines (Ativan given by EMS). UC (-). UA with 3608 RBCs.  RSV and Flu (-).  LP (-).	PVT	PVT	None	Mild URI; no fever	None. PMH: Pt had a cold x 1 day.  Family hx of seizures in grandmother.			1						1	Convulsion	FLU3~SANOFI PASTEUR~UT2456FA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB207BA~1~UN~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0527U~1~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~854013E~4~UN~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1117U~1~UN~RL~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0297248	11/19/2007		0.5			M	11/05/2007	Concerned about Mercury in flu shots caused zombie-like state in her child. MMR - has mercury in it. This causes autism later in life. Why is there mercury in MMR and Flu shots. Senator has been concerned.									U					UNK	UNK						1						1	Autism; Feeling abnormal	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1	USA		Influenza
0297249	11/19/2007	MI	77.0	77		F	11/14/2007	Patient received influenza and Zostavax vaccines on 10/22. the next day she began to feel tired, weak, and generally not well. Over time she noticed shortness of breath with mild exertion. On admission she denied any fever, nausea, vomiting, diarrhea, abdominal pain, chest pain, headache, or neck stiffness. During hospitalization she did present with low grade fever along with previously described symptoms. A large pericardial effusion was detected upon further testing.12/06/07-records received for DOS 11/7-11/14/07-  Developed diarrhea and stool leukocyte positive.Weak, low grade fever, malaise, dyspnea, atrial fibrillation. Impression: probably autoimmune phenomenon possible related to recent immunizations, Pericarditis. Per 60 day follow up: Atrial fibrillation developed during hospitalization related to acute pericarditis. Pt was discharged home 11/14/2007. Patient is still alive, had lab work 1/21/2008.					Y	7			Y	10/22/2007	11/07/2007	16	Spinal CT scan (11/12/07): large pericardial fluid collection; Echocardiogram (11/13/07): moderate to large pericardial present, no tamponade 12/6/07-records received- 2 D echo and CT pulmonary angiogram revealed moderaly large pericardial effusion. CXR normal. Sed rate, erythropoietin  and D-dimer elevated. Urinalysis contained WBC.stool leukocyte positive	UNK	UNK	aspirin, calcium with vitamin D, Centrum, hyzaar, ocuvite, gluten, plendil, Prilosec, Zocor, terazostin		hypertension; hypercholesterolemia; allergies to : amoxicillin, beta blockers, and ciproflaxacin 12/6/07-records received-PMH: UTIs, hypertension, osteoarthritis, gastric reflux, hyperlipidema.			1						1	Asthenia; Atrial fibrillation; Computerised tomogram abnormal; Dyspnoea; Dyspnoea; Echocardiogram abnormal; Fatigue; Malaise; Pericardial effusion; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~UN~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Hospitalisation	Influenza
0297252	11/19/2007	DC	48.0	48		F	11/19/2007	24 hrs. after vaccine: HA, lethargy, lograde T, lower respiratory sx progressing deep, dry cough. Lo-grade T cont x 8 days. Cough persisted x 3 wks. Like a cytokino storm.  &. Wheezing with exercise/bronchoconstriction.									Y	09/14/2007	09/15/2007	1		PVT	PVT		None	Non-erosive rheumatoid arthritis (well controlled)			1						1	Body temperature increased; Bronchospasm; Cough; Headache; Lethargy; Respiratory disorder; Wheezing	FLU3~SANOFI PASTEUR~U2462AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2771AA~1~IM~UN~TDAP (ADACEL)~1|TYP~SANOFI PASTEUR~A0221~2~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0297254	11/19/2007	WI	60.0	60		F	11/19/2007	States 1 3/4 hr. after receiving vaccine felt could not swallow and  lips felt numb - lasted about 10 min then went away and feels fine now -									Y	11/14/2007	11/14/2007	0		PUB	UNK						1						1	Dysphagia; Hypoaesthesia oral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80684~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0297255	11/19/2007	WA	48.0	48		M	11/14/2007	Hives on arm and chest, Zyrtec				Y					Y	11/09/2007	11/10/2007	1		OTH	PVT						1						1	Urticaria	FLU3~SANOFI PASTEUR~U2530AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297256	11/19/2007	LA	27.0	27		M	11/05/2007	Stakes felt heart racing, unable to sleep that night (day after shot given)									Y	11/02/2007	11/03/2007	1		PUB	PUB	Toprol KL, Claritin		decongestant - allergy		LA071103	1						1	Insomnia; Palpitations	FLU3~SANOFI PASTEUR~U2487AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297259	11/19/2007	PA	78.0	78		F	11/15/2007	Rx to injection in (L) arm. Had tetanus shot. Red swollen (L) upper arm with no rash. Prescribed Prednisone 40x2, 30x3, 20x2, 10x2.										11/08/2007	11/15/2007	7	None	UNK	UNK		None				1						1	Injection site erythema; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA300AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|TD~SANOFI PASTEUR~U1927DA~UNK~UN~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0297262	11/19/2007	NY	35.0	35		F	11/06/2007	to ER for severe reaction. Received Decadron 75 mg and Keflex 500 mg tid seen there 11/6/07 @ 1848.									Y	11/05/2007	11/06/2007	1		PVT	PVT						1						1	Adverse drug reaction	FLU3~SANOFI PASTEUR~U2462AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0889F~2~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297263	11/19/2007	CA	1.0	1	.0	M	11/09/2007	Returned 9 days after vaccine due to 1.0x1.5 cm area of redness and swelling in (R) thigh where immuns. were given. This is non-tender									U	10/26/2007			None	PVT	PVT						1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~UT2459MA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~L1158U~3~IM~RL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~1420F~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1022~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0297264	11/19/2007	IN	1.0	1	.0	M	11/19/2007	10 days after MMR and Varivax got fever to 103, congestion/cough and erythema multiforme rash				Y					U	11/07/2007	11/18/2007	11	None	PUB	PUB	amoxicillin 11/8-11/18	otitis media (11-8-07)	None			1						1	Cough; Erythema multiforme; Nasal congestion; Pyrexia	FLU3~SANOFI PASTEUR~U2460FA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0436U~3~IM~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0414U~1~IM~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1358U~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0297265	11/19/2007	OH	69.0	69		F	11/17/2007	Extreme pain-unable to move arm, mother up all night long in severe pain. No pain meds were affective in relief of pain.				Y						11/16/2007	11/16/2007	0		PUB	OTH	Numerous	None				1						1	Injected limb mobility decreased; Pain	FLU3~SANOFI PASTEUR~U2500AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0962U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0297266	11/19/2007	NJ	60.0	60		F	11/07/2007	11/02/07 Pt stopped in to show her left arm redness, slight blueness and a knot at 12:15pm. Bruising in center of lumpt- HT 2.5 x Wd 3 Sore and palpable warm to touch. Instructed to use covered bag of ice x 20 minutes and use Tylenol or Advil as instructed.									Y	11/01/2007	11/02/2007	1	None	PUB	PUB	Unknown	Unknown	Unknown		HJ200709	1						1	Injection site bruising; Injection site discolouration; Injection site erythema; Injection site mass; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U2448AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297267	11/19/2007	NJ	48.0	48		F	11/07/2007	flushed at 12:03 pm, by 12:08 pm Benadryl 25 mg 1 tablet po x 1 for itching at injection site and slightly red 12:20 pm 140/100-64, 12:31-140/90-76; 12:36pm (L) arm heavy and then subsided. At 3:25 pm, she tc'd then RN and c/o throat lumpness. Directed her to ER immediately.				Y					Y	11/01/2007	11/01/2007	0	None	PUB	PUB	no meds no B/P meds	None	Bactrim, sulfa, EES		HJ200708	1						1	Flushing; Injection site erythema; Injection site pruritus; Sensation of foreign body; Sensation of heaviness	FLU3~SANOFI PASTEUR~U2448AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297268	11/19/2007	NJ	50.0	50		F	11/07/2007	11/15/07-pt told to come into office 11/5/07 (L) arm warm to wrist, swelling above elbow and Tx'd warmth around injection site. Had c/o off and on (L) finger numbness decreased this RN noted she need to go to medical department. 11/1/07: She c/o bilateral knee achiness									U	11/01/2007	11/01/2007	0		PUB	PUB	took ibuprofen 600 mg on 11/11/07 and over weekend	Unknown			HJ200709	1						1	Arthralgia; Hypoaesthesia; Injection site warmth; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U2448AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297271	11/19/2007	MA	43.0	43		F	11/19/2007	pain upper (L) arm, body aches T 102.4 F ear thermometer swollen, red, hot to touch, itchy arm painful to touch				Y					U	11/13/2007	11/14/2007	1	blood work, MRI (L) shoulder, IV antibiotics	PVT	PUB	Lipitor 20mg, Zyrtec 10 mg, Singulair 10 mg	10/07 respiratory illness	allergies, asthma, elevated cholesterol, arthritis, fibromyalgia			1						1	Blood test; Body temperature increased; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Nuclear magnetic resonance imaging; Pain; Pain in extremity; Pruritus	FLU3~SANOFI PASTEUR~U2524AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1229F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0297272	11/19/2007	GA	33.0	33		F	11/19/2007	Rash torso same evening ache all over body. Fever Rash lasted less than 24 hrs									Y	11/05/2007	11/06/2007	1	None	PUB	UNK	Multivitamins	None	12/26/06 Allergy - 2/06 Bronchitis Torso rash 05/ GI illness Rash			1						1	Pain; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U2458FC~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297274	11/19/2007	MA	14.0	14		F	11/09/2007	Approximately 12 hrs after receiving vaccine, pt developed fever of 101.9 shaking chills and stiffness in back and neck. Sx abated within 24 hrs.									Y	10/30/2007	10/31/2007	1	None	OTH	PVT	Erygel Flonase	None	allergic rhinitis, EIA, eczema			1						1	Chills; Musculoskeletal stiffness; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U2462AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297275	11/19/2007	MI	6.0	6		F	11/10/2007	Was here today for a flu shot. Within 5 minutes, while driving away from the office she complained of sore throat and began to cough, within another 5 minutes her eyes were puffy, she became itchy and agitated, mom turned car around and returned to the office. Constitutional: General appearance: Mildly distressed., truckal itching, frequent harsh cough; Eyes: Conjunctativa/Lids: Conjunctival edema bilaterally. Upper lids red and quite puffy; Ears, nose, mouth and throat: Ears Tympanic membranes shiny without retraction, Canals unremarkable. Hearing grossly normal. Oral: Inspection of gums, lips, palate, and teeth normal. No scars, lesions, or masses. Oral mucosa unremarkable with non-inflamed posterior pharynx. Uvula midline.;Respiratory: Mild expiratory wheeze heard throughout both lung fields; Cardiovascular: Cardiac: Regular rhythm. No murmurs, rubs, or gallops. PMI not displaced. No thrill. HR 100; Skin: Eyes edematous, generalized itching but no generalized hives or angioedema; Assessment/Plan: E949.9-Adverse effect, vaccine NEC Treatment: 0.15 cc sq Epinephrine 1:100, Oral Benadryl 1 1/2 tsp, and nebulization treatment of 0.375 Albuterol. Treated, and vital signs monitored closely over a 40 minute period, she improved gradually, less eye redness, no more pruritis, and improved chest exam, and was discharged from office care, with instructions to give more Benadryl dose 4 hours after office dose, and to RTC for any exacerbation of symptoms. 1700 spoke w/Mom regarding how patient was doing. Per mom swelling of eyes have resolved as well as sore throat, cough and itching. Mom did give second dose of Benadryl as advised by doctor. I did advise mom should any sx appear such as swelling of eyes, sob, dib, sore throat, coughing to contact on call doctor immediately/911. Asked mom to call w/update tomorrow.									Y	11/06/2007	11/06/2007	0		PVT	PVT						1						1	Agitation; Conjunctival oedema; Cough; Eye swelling; Pharyngolaryngeal pain; Pruritus; Stress; Wheezing	FLU3~SANOFI PASTEUR~U2440AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297276	11/19/2007	CO	77.0	77		F	11/12/2007	Pt has pain that radiates from her shoulder to mid-arm which has lasted > 5 weeks post shot. Her doctor recommended ice packs, but has not helped.				Y					U	10/01/2007	10/02/2007	1	No tests performed	OTH	OTH	Salagon	Sjogren's Syndrome				1						1	Musculoskeletal pain; Pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2453AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297277	11/19/2007	WA	56.0	56		F	11/13/2007	Fever (104 deg), swollen lymph nodes ( (L) axillary), swelling of upper (L) arm. Treatment: Ice, Aleve, cefuroxime 250mg x 10 days twice daily				Y					Y	11/06/2007	11/06/2007	0		OTH	PVT		Sinusitis				1						1	Injection site swelling; Lymphadenopathy; Oedema peripheral; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80825~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1132U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0297278	11/19/2007	CA	15.0	15		F	11/09/2007	c/o feeling faint right after vaccine admin. slumped over. and the had a seizure lasting 5 sec. arms and head jerking. then disoriented for 3 min or so.									Y	11/08/2007	11/08/2007	0		OTH	UNK	None	None	2/6 systolic heart murmur LUSB (innocent)			1						1	Convulsion; Disorientation; Dyskinesia; Immediate post-injection reaction; Syncope	FLU3~SANOFI PASTEUR~U2469AA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0930U~1~UN~RL~HPV (GARDASIL)~1	USA		Influenza
0297279	11/19/2007	OH	0.5	0	.5	F	11/14/2007	Urticarial rash of face appeared 2 hours after administration				Y					Y	11/10/2007	11/10/2007	0	Patient to follow up with allergist for skin and egg testing	PVT	PVT	none	upper respiratory tract infection	none			1						1	Allergy test; Rash; Skin test; Urticaria	FLU3~SANOFI PASTEUR~uU2501AA~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297280	11/19/2007	WI	58.0	58		M	11/12/2007	103 degrees Temperature on Saturday, 99 degrees on Monday redness in the left arm; left arm pain; treatment: Tylenol, Benadryl, and Claritin PRN				Y					Y	11/09/2007	11/10/2007	1		PVT	UNK		No known illness	low back pain, hypercholesterolemia, asthma,ED, allergic rhinitis, eczema			1						1	Body temperature increased; Erythema; Pain in extremity	FLU3~SANOFI PASTEUR~U2499AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0962U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0297281	11/19/2007	CA	43.0	43		F	11/07/2007	15 min p injection Rt arm pain, hot/face flush, felt weird fatigued, arm very painful. Took a darrocet that night. On 11.7.07 in am awoke arm swollen some warm to touch. area around injection site pink-red. hard/indurated. pain up neck/shoulder, pain into shoulder blade + down waist. took Advil and Benadryl/ which helped.									Y	11/06/2007	11/06/2007	0		OTH	OTH	Allegra D 160mg BID; Estradlol 1mg Q Day; Singular 10mg Qday		environmental allergies, asthma			1						1	Fatigue; Feeling abnormal; Flushing; Hot flush; Injection site discolouration; Injection site erythema; Injection site induration; Musculoskeletal pain; Neck pain; Oedema peripheral; Pain; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~U24663AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297283	11/19/2007	CA	5.0	5		U	11/12/2007	Headache c/o pain immediately upon admin. of vaccine. Followed Rapidly by Urticarial Reaction (redness) nose, eyelids, cheeks + 2 solitary urticaria on R ant. chest									Y	11/12/2007	11/12/2007	0		PVT	UNK	Fluoride, MVI	None	None			1						1	Erythema; Headache; Ocular hyperaemia; Pain; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500480P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0297285	11/19/2007	OH	72.0	72		F	10/18/2007	Patient stated she was feeling well today. Received flu vac, shortly after she sat in waiting area saying she felt dizzy. We offered assistance and food. She went home, we called to make sure she was doing  two hours later. Husband said she was resting									U	10/18/2007	10/18/2007	0		OTH	UNK						1						1	Dizziness	FLU3~SANOFI PASTEUR~U2507AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297289	11/19/2007	TX	53.0	53		F		Tues - 10/9/07 at 10:00 received Flu vaccine and the pneumonia vaccine in my Rt deltoid. By noon, felt achy, malaise, feverish. Rt deltoid and arm hot to touch, red, edema in Rt arm, across shoulder and around to Rt scapula. By 4 pm head hurt, neck sore and needed to lay down. Sx continued to spread entirely to muscles and joints on Rt side only. I stayed in bed and couldn't move (I should have gone to the hospital in hindsight). Wednesday, I did nothing but lay in bed. Awoke Wed AM and increased T 102 and Rt hip joint pain and lower back joints hurt and difficult to walk. started crying uncontrollably, congestion and breathing difficulties - started my nebulizer QID. Thurs late afternoon had an appt, felt joint sx decreasing a bit, but despair, tearfulness was severe (I forgot to mention that on Tues late - my well managed asthma increased and went back on the albuterol nebulizer QID and Asthmacort). Had an appt late Thurs - lungs real bad. Thurs around 5:30 pm, total despair, crying uncontrollably and wanted to just drive my car into a brick wall. I knew this was not right - I am more optimistic than pessimistic. I called friends that were RN's who knew me for years. We had agreed that I would not harm myself. They would hourly around the clock to check on me. I promised to go home and to bed. Fri - I had a pre-op appt at hospital and cried uncontrollably during most of my pre-op visit. The edema decreased on the scapula and most of the Rt arm. Hip still sore, redness and edema decreased on most of Rt arm, shoulder, hands, still noticeable to the trained eye. Rt hip joint, pelvis joints very painful to walk, knee and foot joints less painful. I was still having productive cough from lower lobes lt side lungs, especially after laying down or after a treatment. CXR at time of pre-op (noon Friday) results unknown. I cried about everything and malaise, headache, etc. I was told that I needed the flu shot (which I have gotten every year since 1976) in order to be around my mom who was on hospice. I have not had an adverse rxn to the flu vaccine since 1976. I stayed in bed Sat, Sun, Mon. Sx were gradually better - still treating the lungs and severe discomfort in Rt hip continued. Thus sx were minimal - residual asthma and Rt hip pain. NPO Wed - 10/17/07 had GB removal lapriscopically, just had to bring asthma inhalers with me. Stayed at home post op and spent most of time in bed and doing breathing tx. On Friday 10.19, I scheduled appt with doctor for Monday, Oct 22. Still felt some malaise on Monday Oct 22, 2007. I had continued with the nebulizer Proventil QID. I used MDI - Asthmacort QID. Still had some malaise, Rt hip pain continued. still had post-op discomfort (was to be totally expected). Doctor examined me - my lungs were only having productive coughing upon arising after sleeping and sometimes after a treatment. She gave me 12 different injections and 2 Rx's. Toradol 60mg IM, Ceftin 500 BID x 10 days, Prednisone taper. Today is Nov 2, 2007 - I find an occasional productive cough and my Rt hip is very sore - positional pain/discomfort. Rec stretches - heat, Yoga - if increased - refer to ortho. I have included a list of my medications, medical conditions, adverse rxn's to medications, and my treating physicians									U	10/09/2007	10/09/2007	0		PVT	UNK	Neurontin; Duragesic Patch; Namenda; Metformin; Crestor; Synthroid; Singulair; Claritin; Furosemide; Spironolactone; K-Dur; Zenical; Flexeril; Prilosec; Lactulose; Percocet; Promethazine; Relpax; Librax; Flonase; Azmacort; Proventil		Medication Sensitivities: Latex, Robaxin, All Decongestants, Serevent/Advair, Tegretol, Keppra, Baclofen, Dilantin, Valproic Acid, Topamax, Lyrica, Trileptal, Cymbalta; Medical Conditions: Trigeminal Neuralgia, Chronic Pain Syndrome, Asthma, DDM II, Allergies, Sleep Apnea, Water Retention, Osteoarthritis			1						1	Arthralgia; Back pain; Body temperature increased; Condition aggravated; Crying; Dyspnoea; Erythema; Feeling of despair; Gait disturbance; Headache; Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth; Malaise; Musculoskeletal discomfort; Musculoskeletal pain; Nasal congestion; Neck pain; No reaction on previous exposure to drug; Oedema peripheral; Pain; Pelvic pain; Productive cough; Pyrexia; Skin warm; Surgery	FLU3~SANOFI PASTEUR~U2442AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0200U~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297290	11/19/2007	NE	52.0	52		F	11/11/2007	Swelling, warm to touch, bruise type soreness. 2-3 days with ibuprofin and ice.									Y	11/08/2007	11/08/2007	0	None	PVT	UNK	Timolol mal scl; Lotrel (Amlodipine benzepril);  Premphase, phentermine; Tetracycline, multivitamin	None	HBP/Rosacea/Glaucoma			1						1	Contusion; Pain; Skin warm; Swelling	FLU3~SANOFI PASTEUR~U2437AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297292	11/19/2007	PA	20.0	20		M	11/13/2007	24 hrs post flu vacc (11/9/07) had vibration sensation (L) deltoid (site of vacc) lasting 4 days (thru day of report). No loss of strength, (L) arm no pain.									Y	11/09/2007	11/10/2007	1	None indicated	UNK	PUB	None	None	None			1						1	Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA309AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0297293	11/19/2007	OH	2.0	2	.6	F	11/08/2007	Welty rash - generalized (trunk, legs, neck)									Y	11/06/2007	11/07/2007	1	None	PVT	PVT		None	None			1						1	Rash generalised; Urticaria	FLU3~SANOFI PASTEUR~UT2460AA~4~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297295	11/19/2007	MA	1.0	1	.2	F	11/19/2007	Macular papule, Rash on trunk + Back 10 days post immu.									Y	11/09/2007	11/18/2007	9		PVT	PUB	None	None	None			1						1	Rash; Rash maculo-papular	DTAPH~SANOFI PASTEUR~UF201AA~4~IM~LL~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~UT2460AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0183U~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~13670~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0297296	11/19/2007	SC	2.0	2	.7	M	10/29/2007	None reported.										10/29/2007				PVT	PVT		Otitis Media				1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U252AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297297	11/19/2007	WI	11.0	11		F	11/02/2007	Mother returned with patient about one hour after receiving flu shot. Patient was experiencing coldness and some duskiness in (L) arm. Mother stated that there was mottling earlier. Arm was checked by doctor. Warmness applied to arm. Patient was observed then sent home. The next day mother called doctor due to symptoms continuing. Doppler studies were ordered.				Y					U	11/01/2007	11/01/2007	0	Doppler studies	PVT	UNK		None	Mild anemia due to Thalassemia Vara, born 10 wks premature, seizures in infancy.			1						1	Livedo reticularis; Pallor; Peripheral coldness; Ultrasound Doppler	FLU3~SANOFI PASTEUR~U2442AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297299	11/19/2007	TN	71.0	71		F	11/12/2007	site redness, site swelling, chills, site itching, weakness, dizzy									Y	11/02/2007	11/02/2007	0		OTH	PVT	Celebrax; diavan	none	Osteoarthritis, HTN			1						1	Asthenia; Chills; Dizziness; Injection site erythema; Injection site pruritus; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA294BA~4~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~096IU~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297301	11/19/2007	MI	42.0	42		F	11/08/2007	Vaccines administered 10-26-07. 11-2-07 noticed sores on tongue. 11-3-07 Swollen gums, ? elevated temp, mild chills off and on. 11-4-07 Noted lymph node swelling in (L) neck area, sores in mouth increased. 11-5-07 Generalized tiredness, malaise, gums and mouth sore, swollen. 11-6-07 Lips swollen, gums may be more swollen? 11-7-07 Seen by doctor.										10/26/2007	11/02/2007	7		PVT	OTH			Allergic to Keflex, nickel, seafood, pollen, dust, molds			1						1	Body temperature increased; Chills; Fatigue; Lip swelling; Lymphadenopathy; Malaise; Oral pain; Swelling; Tongue ulceration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80070~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C2759AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0297303	11/19/2007	CT	34.0	34		F	11/07/2007	got vaccine 10AM 11/6 woke at 230 AM 11/7 with cold sweats, chills, arms felt heavy and hurt to move and whole body ache and numbness in arms now headache, nausea, pain left arm									U	11/06/2007	11/07/2007	1	none	OTH	PUB	Protonix occasionall	none	none			1						1	Chills; Cold sweat; Headache; Hypoaesthesia; Nausea; Pain; Pain in extremity; Sensation of heaviness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA309AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0297304	11/19/2007	NJ	47.0	47		F	11/08/2007	Phone call made by pt, she c/o (L) deltoid tender to touch after vaccine admin. On 11/8/07 pt c/o nausea and headache.									N	11/07/2007	11/08/2007	1	None	PUB	PUB	Claritin	None	Seasonal allergies and cats and dogs			1						1	Headache; Injection site pain; Nausea	FLU3~SANOFI PASTEUR~U2448AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297305	11/19/2007	NJ	14.0	14		M	11/18/2007	Soreness at site of injection at L Delt 1 hr p admins of vaccine 11/7/07.									N	11/07/2007	11/07/2007	0	None	PUB	PUB	None		Seasonal allergies			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U2448AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297306	11/19/2007	CA	44.0	44		M	11/09/2007	CHILLS, TEMP, BODY ACHES, NAUSEA & VOMITING. INCREASED BODY PAIN. R ARM PAIN, REDNESS, SWELLING. HEADACHE, DIZZY. SEVERE BACK PAIN. STINGING AND HOT. BRIGHT RED RASH R ARM. PER DR.				Y					U	10/15/2007	10/16/2007	1	Comp. metabolic panel, CBC c auto. diff., Blood cultures, Urinalysis.	PVT	PVT		ESTABLISHING w/NEW PCP	KEFLEX - RASH			1						1	Back pain; Blood culture; Body temperature; Chills; Dizziness; Erythema; Full blood count; Headache; Hot flush; Laboratory test; Nausea; Pain; Pain in extremity; Rash; Swelling; Urine analysis; Vomiting	FLU3~SANOFI PASTEUR~79241~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~O961U~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0297308	11/19/2007	MO	78.0	78		F	11/15/2007	Husband stated about 1 week after flu shots wife lost interest in daily activities, didn't feel good-acted like she was overdoses.									U	10/23/2007			had MRI 11-14-07 has EEG scheduled	PUB	UNK	Triavili, Synthroid, Micoidis, Prilosec fluid tablets	None				1						1	Abnormal behaviour; Activities of daily living impaired; Electroencephalogram; Feeling abnormal; Nuclear magnetic resonance imaging	FLU3~SANOFI PASTEUR~U2523AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297309	11/19/2007	VT	62.0	62		M	11/14/2007	Pt received annual Flu Shot and pneumovax at approx noon on 11/7. felt until dinner time when he began developing shaking chills, temperatures to 102-103 degrees F, severe headache, and his left deltoid became swollen red hot where injections were given. Symptoms lasted 48 hours.									Y	11/07/2007	11/07/2007	0	NONE	PVT	PVT		NONE	NONE			1						1	Body temperature increased; Chills; Headache; Injection site swelling; Injection site warmth; Tremor	FLU3~SANOFI PASTEUR~U2492AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1344U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297310	11/19/2007	PA	18.0	18		F	11/01/2007	Patient states rash and itching started 4 hours after receiving FluLaval. Itching on wrists and left ankle. Patient applied calamine lotion to itching with temporary relief. Patient came to health center for treatment 2 days later. She was given chlorpheniramine maleate 4 mg #20 to take one time qid prn po.									Y	10/30/2007	10/30/2007	0	None	OTH	PUB	Yasmin	None	None			1						1	Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA053AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0297311	11/19/2007	MA	0.6	0	.6	M	11/13/2007	fever after vaccine on 11/13/07									U	11/13/2007	11/13/2007	0	None	PVT	PUB		None				1						1	Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B129AA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~072774AA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~OF92AA~3~IM~LA~HIB (ACTHIB)~1|PPV~MERCK & CO. INC.~B70193A~3~IM~RL~PNEUMO (PNEUMOVAX)~1|RV5~MERCK & CO. INC.~1192U~7+~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0297312	11/19/2007	MA	52.0	52		F	11/12/2007	10/31/07 Rt arm pain, chills, passed out, tired, site red and warm - 2.5cm diameter, T-100.4. Keflex 500mg 4x1 day x 10d.				Y					Y	10/29/2007	10/30/2007	1	CBC 10/31/07	PVT	UNK	Proventil,Propranolol; Singulair, Flonase, Zaditor					1						1	Chills; Fatigue; Full blood count; Injection site erythema; Injection site warmth; Loss of consciousness; Pain in extremity	FLU3~SANOFI PASTEUR~U2516AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1229F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0297313	11/19/2007	MA	1.0	0	1	F	11/15/2007	Positive URTICARIA - stated day of vaccine administration 11/2/07, on legs, spread to other areas by 11/3/07									U	11/02/2007	11/02/2007	0	Nohlo egg allergies, able to eat eggs but- avoidingly: Willter RAST after current rash	PUB	PUB		Urticaria after vaccine				1						1	Food allergy; Radioallergosorbent test; Rash; Rash generalised; Urticaria	FLUX~UNKNOWN MANUFACTURER~U24588~1~UN~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0297314	11/19/2007	FL	74.0	74		F	11/14/2007	Pt stated one hour after shot (PPV) given-arm swollen and was red. She started I talked to pharmacist after I put cold compress on arm and was advised to take Benadryl. Arm no longer itches-still swollen, but better. (Pt. described what sounded like cellulitis)									U	11/12/2007	11/12/2007	0	None	OTH	PUB	Synthroid, Diovan (Hypertension)	None	None			1						1	Cellulitis; Erythema; Oedema peripheral; Pruritus	FLU3~SANOFI PASTEUR~U2448AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1138U~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297315	11/19/2007	TX	39.0	39		F	11/15/2007	Very uncomfortable aching all the way down my arm to finger tips lasted about 12-14 hrs.									Y	10/03/2007	10/03/2007	0		OTH	PVT	None	None	None			1						1	Pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA042AA~6~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0297316	11/19/2007	TX	38.0	38		F	11/14/2007	Pain at injection site swelling, sore joints, fever, back pain									Y	10/03/2007	10/04/2007	1		OTH	PVT	Paxil	None	asthma	Extreme Illness~Pneumo (no brand name)~1~30.00~In Patient		1						1	Arthralgia; Back pain; Injection site pain; Injection site swelling; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA 042AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0297317	11/19/2007	MI	87.0	87		M	11/07/2007	Was taken by ambulance to ER on 10-30-07 with BP of 100/20 and vomiting. He was in the ER for 6 hrs and was given IV therapy. CLIENT STATES HE ATE SOME OLD LUNCH MEAT + STARTED VOMITING SHORTLY AFTER.				Y					Y	10/29/2007	10/30/2007	1		PUB	PUB	Lupron, Coreg + Trental.	Prostate Cancer + HTN	Allergic to codeine Has HTN + prostate cancer	None~ ()~~0.00~In Patient		1						1	Blood pressure decreased; Food intolerance; Vomiting	FLU3~SANOFI PASTEUR~PMCU2501AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297319	11/19/2007	FL	2.0	2	.8	F	11/16/2007	Flu shot was given on 11-12-07 child had fever x2days.									Y	11/12/2007	11/16/2007	4		PVT	PVT	Tylenol	Coughing				1						1	Pyrexia	FLU3~SANOFI PASTEUR~UT2474eA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297320	11/19/2007	MI	1.3	1	.3	M	11/13/2007	PHN gave Tdap instead of Dtap. see attached MICR and Immz. flow sheet. Dr Notified by phone at 1615. 11/14 TC from Dr's office Re what vaccine given on 11/14/07; 11/15/07 PHN called Dr's office - child seen PA Temp of 101 deg; throwing up for 12 hours (7p to 7Am) on 11/13/07 fussy. getting Oral Tylenlol										11/13/2007				PUB	PUB	None	None	None			1						1	Body temperature increased; Inappropriate schedule of drug administration; Irritability; Medication error; Vomiting; Wrong drug administered	FLU3~SANOFI PASTEUR~UT2477DA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2644AA~4~IM~RL~TDAP (ADACEL)~1	USA		Influenza
0297321	11/19/2007	MD	25.0	25		F	11/19/2007	10 min after flu shot given tounge swelled, difficulty breathing, dizziness. Sent to hospital in ambulance				Y					Y	11/15/2007	11/15/2007	0		OTH	PVT	None	None	allergic to compazine and cipro			1						1	Dizziness; Dyspnoea; Swollen tongue	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297323	11/19/2007	NH	49.0	49		F	11/04/2007	Gastrointestinal: Nausea, diarrhea (foul smelling), cramping, lower abdominal pain, fatigue, chills, headache									U	11/03/2007	11/03/2007	0		MIL	MIL		Restricted Diet\No digestive enzymes	Dust, Dustmites, cats, feathers - Food intolerances.	See #7~Influenza (Seasonal) (FluMist)~UN~49.00~Patient		1						1	Abdominal pain; Abnormal faeces; Chills; Diarrhoea; Fatigue; Headache; Nausea	FLUN3~MEDIMMUNE VACCINES, INC.~500496P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0297327	11/19/2007	WI	41.0	41		F	11/13/2007	Within 2-3 hours post vaccine administration developed pains mild chest and shooting down left arm. which continued into next day. 10-30-07 co doctor-EKG: work-? pulled muscle. 11-2-07 enzymes checked. WNL- Pain completely resolved 11-9 or 11-10-07 ( was instructed to take ibuprofen prn - did not take as pain was tolerable. No further episodes of pain since resolved.				Y					Y	10/29/2007	10/29/2007	0	EKG + blood enzymes (cardiac)	OTH	PUB	Premarin Prometrium x8 years	none	Hodgkin's disease, tr: chemotherapy x8 months	none known~ ()~~0.00~In Patient		1						1	Cardiac enzymes; Chest pain; Electrocardiogram; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLAO3OAA~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0297224	11/20/2007	MD	79.0	79		M	11/19/2007	Pt awoke 4 days after his vaccination with complete loss of hearing in the left ear, vertigo and nausea. CT scan of the head is negative. MRI/MRA pending. 12/26/07-records received consult 11/16/07-sudden loss of hearing left ear and vertigo with nausea and vomiting. Ataxic. CT Admitted for stroke evaluation.Incision of eardrum procedure. Balance improving as of 12/4/07 however hearing loss remains. Follow up in 1 year. Per 60 day follow up: Permanent deafness in left ear. Have there been any other reports of sudden sensorineural hearing loss/deafness after flu vaccine? 1/15/2010 Complete unilateral deafness.				Y	Y	1		Y	N	11/15/2007	11/19/2007	4	CT Brain Negative; MRI/MRA pending 12/26/07-records received-negative. MRI/MRA negative. Audiogram-mild to severe sensorineural hearing loss left ear.	UNK	UNK	Enalopril; Zocor; atenolol	hypertension, Diabetes NIDDM; hypercholesterolemia	12/26/07-records received-PMH: hypertensive diabetic with hypercholesterolemia.			1						1	Computerised tomogram normal; Deafness unilateral; Nausea; Scan brain; Vertigo	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Hospitalisation,Disabling	Influenza
0297328	11/20/2007	FL	50.0	50		M	11/20/2007	Got a flu shot on Oct. 11 and had very strong reaction and personal injury. I had a little fever for two days. On Oct. 28, I felt uncomfortable on my left face. Two days later, the situation became worse. I could not close my left eye and mouth. My left side facial nerve and muscle were totally out of control. So I went to Hospital ER to check what was wrong. Doctor diagnosed finally I got Bell's Palsy because of virus infection. However during that time period, I did not have any virus touched or infected except the flu shot virus that was injected into my left arm. My primary doctor confirmed last Friday that it was highly possible that my face paralysis was related to the flu shot. 12/4/07-records received for DOS 10/30/07-DX: Bell's Palsy CN VII neuropathy. C/O left sided facial numbness. History of 3 days with facial paralysis unable to closee left eyelid. Able to wrinkle forehead.  Per 60 day follow up: I want to investigate the side-effect of the vaccine Influenza that the manufacturer did not tell patients or did not realize.								Y	Y	10/11/2007	10/28/2007	17	12/4/07-records received-CT brain normal.	UNK	UNK						1						1	Facial pain; Facial palsy; Pyrexia; Viral infection; Facial palsy; Hypoaesthesia facial; Scan brain	FLU3~SANOFI PASTEUR~49281-380-15~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2462AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Disabling	Influenza
0297358	11/20/2007	ND	35.0	35		F	11/20/2007	Vaccine was administered on 11/1/07 @ 0700 hr.  At 1300 hr after eating lunch she developed some tightness in her throat.  No new foods eaten.  She was given Benadryl 25 mgs p.o. and symptoms were relieved and did not reappear.									Y	11/01/2007	11/01/2007	0	none	UNK	UNK	none	none	none	none~ ()~NULL~~In Patient|N/A~ ()~NULL~~In Sibling1		1						1	Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA030AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0297360	11/20/2007	IL	77.0	77		F	11/01/2007	Developed itching around 2-3 p.m. then rash appeared and covered entire body.  5 p.m. having problems with nausea.  Had tried to call family Dr. after closed.  T/C to health department advised of need to go to ER.  6 p.m. chills/fever took ASA and Crotison plus 10 applied to rash.  Awake during the night with itching and feeling bad.  Denied breathing problem.									Y	10/30/2007	10/30/2007	0	11/01/07 status felling fine now.  Denies ever going anywhere for treatment	UNK	UNK	Toprol XL, Diova 160/25, Tenex, ASA, Pravachol, Prempro, Ditropan, Folic Acid, NT6 patch	none	Allergies to Iodine, Epinephrine; Hx of angioplasty, right renal artery stent, osteoporosis		MO200738	1						1	Feeling abnormal; Nausea; Pruritus; Rash generalised	FLU3~SANOFI PASTEUR~U2501AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297362	11/20/2007	CO	19.0	19		F	11/20/2007	Minutes after receiving the HPV, patient beacme pale and dizzy. She then felt like her head was on fire, vision went black,couldn't hold up her head, couldn't move her body, speech slurred, felt like fainting, head kept dropping, left arm asleep and fingers cold, nauseus, blood pressure drop.									Y	11/19/2007	11/19/2007	0		UNK	UNK	none	none	none			1						1	Blood pressure decreased; Dizziness; Dysarthria; Hypoaesthesia; Hypokinesia; Nausea; Pallor; Peripheral coldness; Posture abnormal; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPVX~UNKNOWN MANUFACTURER~~UNK~~~HPV (NO BRAND NAME)~1	USA		Influenza
0297364	11/20/2007	IA		0	.0	F	11/20/2007	Moderate to severe generalized joint pain, pitting edema in lower legs, slight edema to joints at base of great toes, index fingers and thumbs, and slight edema of knees. This started on 10/31/07 is is still present today. Examined by Dr. 11/16/07.									N	10/29/2007	10/31/2007	2	CBC, ERS drawn 11/16/07 normal	UNK	UNK	Zyflo, Zyrtec, Nasonex, estrogen patch, vitamin D, calcium, albuterol PRN	none	asthma, autonomic neuropathy, allergic to: Ceclor, Flagyl, Amantadine, x-ray dye	knee pain x 3 months~Tdap (Adacel)~1~49.80~In Patient		1						1	Arthralgia; Contrast media allergy; Full blood count normal; Joint swelling; Oedema peripheral; Pitting oedema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80435~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0297365	11/20/2007	MS	79.0	79		F	11/14/2007	L arm red and itching 2 days after flu shot received. c/o some dizziness, cough, flu body aches. Has not been in clinic before today because of flu like symptoms. Dr. suggested benadryl cream and warm soaks. Advised to go to PMD if conditon worsens.									Y	10/26/2007	10/28/2007	2	n/a	UNK	UNK	Allegra, Osteobioflex, MSM, B-12, ASA	none	Dust, Pollen		MS07032	1						1	Cough; Dizziness; Erythema; Influenza like illness; Pain; Pruritus	FLU3~SANOFI PASTEUR~U2445AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297367	11/20/2007	PR	64.0	64		F	11/20/2007	Was notified by Hospital Epidemiologist that patient was admitted on November 3, 2007 with progressive weakness progressing to respiratory failure.  Presumptive diagnosis of Guillain-Barr Syndrome(GBS). At present under medical treatment on mechanical ventilation in  ICU. Follow-up: On 11/14/2007 patient was diagnosed with GUILLAIN-BARRE Syndrome by the neurologist.  01/17/2008 MR received for DOS 11/03/2007-1/13/2008 with DX:  Guillain-Barre Syndrome, Respiratory Failure, Diabetes Mellitus Type 2, UTI, Bedridden.  Pt initially presented with c/o intractable abdominal pain with gastritis confirmed per endoscopy (also GERD and esophagitis). Pt developed lower extremity weakness and decreased sensation noted 11/6/07.  Neuro consult with differential dx of atypical early Guillain-Barre. (+) neuropathic pain. Ataxia noted 11/6/07. DTR loss noted 11/12/07 as well as respiratory failure. Pt intubated, placed on mechanical ventilation and transfered to ICU. By 12/7/07 Neurophysiology consult reports Axonal Acute Inflammatory Polyneuropathy with evidence of a loss of axons of approx 80%. Evidence of demyelination in all 4 extremities. Prognosis poor. 1/15/2010 Patient was discharged home January 13, 2008 on mecbonic ventitlator, bedridden.			Y	Y	Y	71	Y		N	10/23/2007	11/03/2007	11	Labs and Diagnostics:  UC 12/11/07 (+) for pseudomonas. UA with 10-15 WBCs and 30 RBC. CBC with WBC 11.9.  CSF culture (-). CSF protein 268.2.  CSF Glucose 172.  Vit B12 1352.  EBV IgG 6.2. IgM 0.05. CMV IgG 256.7. Anti ds DNA 61.6.  IgG 2275.  IgA 527.  IgM normal 63.	UNK	UNK			PMH: CAD, DM, CABG, Asthma. Bells Palsy.  NKDA			1						1	Asthenia; Guillain-Barre syndrome; Intensive care; Mechanical ventilation; Respiratory failure; Abdominal pain upper; CSF glucose increased; CSF protein increased; Cytomegalovirus antibody; Epstein-Barr virus antibody; Gram stain negative; Intensive care; Intubation; Lethargy; Movement disorder; Muscular weakness; Respiratory distress	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80063~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80063~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Life Threatening,Hospitalisation	Influenza
0297368	11/20/2007	NY	20.0	20		M	11/20/2007	Flu Mist given 15 days after smallpox vaccination.									Y	11/17/2007	11/19/2007	2	None	MIL	MIL	None	None	None			1						1	Inappropriate schedule of drug administration; Unevaluable event	FLUN3~MEDIMMUNE VACCINES, INC.~500477P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0297372	11/20/2007	CA	9.0	9		F	11/20/2007	1 hour after receipt of nalsal Flu Mist vaccine Temp orally to 102 F, hives, migraine headache				Y					Y	11/07/2007	11/07/2007	0	Strep throat rapid test was negaitive	UNK	PUB		Reports not feeling well prior to receipt of vaccine, was experiencing a headache	Penicillin, sulfa based antibiotics			1						1	Body temperature increased; Headache; Streptococcal identification test negative; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500487P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0297373	11/20/2007	MD	45.0	45		F	11/20/2007	Fatigue, Anxiety, and numbness/tingling of lower extremities. Patient transfered to Hospital. Epiniphrine and Benadryl given pror to transport.				Y					U	11/20/2007	11/20/2007	0	None.	MIL	MIL	None	None	Anxiety disorder.			1						1	Anxiety; Fatigue; Hypoaesthesia; Paraesthesia	FLUN3~MEDIMMUNE VACCINES, INC.~500477P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0297374	11/20/2007	CA	59.0	59		F	11/20/2007	Patient reports experiencing accelartated speech and thinking 15-20 after receipt of vaccine lasting several hours. Hyperverbal behavior was noted by fellow staff.									U	11/14/2007	11/14/2007	0		UNK	UNK	unknown	none	unknown			1						1	Speech disorder; Thinking abnormal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79849~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0297375	11/20/2007	VA	5.0	5		M	11/20/2007	24 hours after patient received Flumist, he developed a cough.  The next day he developed fever, which persisted for 4 days.  He was seen in the ER on 19 November, 5 days after the immunization, and diagnosed with pneumonitis and RLL pneumonia.  Treated with albuterol, Zithromax and prednisolone.				Y					U	11/14/2007	11/15/2007	1		MIL	UNK	Singulair	None	Allergic rhinitis.  Allergy to pcn.  Reactive airway dx (no firm dx of asthma)			1						1	Cough; Lobar pneumonia; Pneumonitis; Pyrexia; Chest X-ray abnormal; Cough; Pneumonia; Pneumonitis; Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500484P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Emergency room visit	Influenza
0297376	11/20/2007	TN	37.0	37		M	11/20/2007	patient called the office one day after vaccine reporting watery eyes, cough, lip swelling, mild dyspnea and no arm pain or swelling at the inj. site.  Patient took benadryl and medrol dose pack and reported much improvement.									Y	11/19/2007	11/20/2007	1		UNK	UNK	Medications:?? prepare to print? ? print and give pt.? ? Show Hx of medications? ? Drug/Herb Interactions  Flonase Nasal Aerosol, Spray 50 mcg/Actuation 1 spray in each nostril daily Tylenol Orally PRN Zyrtec Oral Tablet 10 mg 1 tablet by m					1						1	Cough; Dyspnoea; Lacrimation increased; Lip swelling	FLU3~SANOFI PASTEUR~U2463AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297378	11/20/2007	NC	8.0	8		M	11/20/2007	.  Got flu shot at 4:30 yesterday, then about 1AM  felt SOB, and wheezing.  Almost became panickly b/c felt couldn't take a deep breath in.  Raspy voice today.  No hx of egg allergy.  Feel SOB today.  Some runny nose started today.  Some fever today.  ST initially this AM now resolved.  Decreased appetitie.  Nauseated from coughing last night, resolved now.  Has never had flu vaccine prior.				Y					Y	11/19/2007	11/20/2007	1	pulse ox 98%	PVT	PUB	none	none	Occular albinism			1						1	Decreased appetite; Dysphonia; Dyspnoea; Nausea; Oxygen saturation; Panic reaction; Pyrexia; Rhinorrhoea; Wheezing	FLU3~SANOFI PASTEUR~M2490AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297379	11/20/2007	MN	42.0	42		F	11/20/2007	Left arm pain from elbow to shoulder. Left sided chest pain that radiated to mid sternum. Shortness of Breath. Pain more localized on the left side of chest and into rib cage area. Pain level was severe. Went into the emergency room and received pain medication, Ekg, Blood work and Chest Xray.				Y					Y	11/16/2007	11/18/2007	2	Patient stated that the Doctor's report stated: Chest wall pain related to flu shot. Blood work, EKG, Chest xray done. All the tests results were normal.	PUB	PVT	Premarin, Trazodone, Citalopram	None	Has had previous medical surgery's and depression.			1						1	Blood test normal; Chest X-ray normal; Chest pain; Dyspnoea; Electrocardiogram normal; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80822~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0297380	11/20/2007	CA	20.0	20		F	11/20/2007	within 2.5 to 3 hrs after shot patient had difficulty walking, severe pain in lower right back, pain down right leg, constant Nausua and all over itching. after doctor visit on 10/12/07 and 12 hour ER visit on 10/13/07. SEVERE PAIN and symptoms were unmanagable at home so doctor admitted haer to hospital on 10/15/07.1/17/08-records received for DOS 10/15-10/24/07-DC DX: Muscle spasm pain in right flank. Developed right flank pain four days prior to admission. Seen in ED twice.				Y	Y	9			Y	10/11/2007	10/11/2007	0	Patient was tested for any other posible causes of pain an symptoms all test were negative. Doctors final diagnosis was negative reaction to flu shot.  She was out of work from 10/11 - 11/07/2007. 1/17/08-records received-CT in ED read as distal right ureter and mild right hydronephrosis. MRI scan of thoracic and lumbar spine normal. IVP-no evidence for hydronehprosis. Labs WBC 10.5. granulocytes elevated 7.1, urine occasional bacteria, rare mucus. Urine culture . Gram stain 2+ small gram negative rods. Calcium low 8.4.	UNK	UNK	Ortho tricyclin LO. advair	check up for asthma visit	asthma 1/17/08-records received-PMH: asthma and mirgraines.			1						1	Back pain; Gait disturbance; Immunisation reaction; Laboratory test; Nausea; Pain in extremity; Pruritus generalised	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0297382	11/20/2007	OH	82.0	82		M	11/20/2007	Patient developed symptoms of upper extremity weakness 3 days after the flu vaccine, progressing to lower extremity weakness within a few hours of upper extremity weakness onset.  Lower extremity weakness progressed to difficulty ambulating to nearly a plegic.  Patient was treated with a course of steroids.  Patient remains ventilator dependent and requires extensive physical therapy to regain function.  Recovery is pending.  At the time of form submission the patient was day #29 of hospital admission and being reviewed for transfer.  03/07/2008 MR received for DOS 10/28-11/26/2007 with D/C DX: Transverse Myelitis.  Urinary Tract Infection.  Pt presented to local hospital with bilateral upper extremity numbness and tingling which later extended to the lower extremities which began 3 days s/p flu shot.  Progressed to weakness and walking difficulty until pt was unable to walk-almost total plegia of the lower extremities. Initially improved on steroids but developed hypotension, tachypnea, tachycardia, and deteriorated atrial fibrillation and was transfered to higher level of care. Pt was febrile, BP upon arrival 60/20. Ultimately developed multi-system organ failure 2' to Gram (-) sepsis. Intubated and G-tube placed. Trached on 11/24/07. Discharged to rehab on 11/26/08.				Y	Y	29				10/19/2007	10/23/2007	4	Lumbar puncture negative for infectious process.  MRI indicative of transverse myelitis versus atypical Guillain Barre.  Labs and Diagnsotics: LP (-). MRI spine revealed a demyelinating process felt to be transverse myelitis.  CK 1541. CK-MB 1.1. Troponin T 0.98BUN 79. Creatinie 3.5. ALT/AST 203/279. UA with moderate WBCs and TNTC RBCs. UC (+) for E. coli and later Psuedomonas aeruginosa.  CT chest/abd abnormal. Renal US with  prominant L renal pelvis.  PT 122.pro-B Type Natriuetic Peptide 3965.  Blood culture (+ for coag (-) Staph species. EMG /NCS c/w significant peripheral neuropathy.	UNK	UNK	lisinopril, simvastatin, allopurinol, aspirin, metformin, and folate	N/A	hypertension, diabetes mellitus, dyslipidemia, coronary artery disease, degenerative joint disease, chronic renal insufficiency, cataracts, carotid disease, paroxysmal atrial fibrillation. PMH: HTN, NIDDM, hyperlipidemia, CAD, DJD, chronic renal insufficiency, R eye cataract, laminectomy, microdiscectomy, foraminectomy.  NKDA.			1						1	Gait disturbance; Lumbar puncture normal; Mechanical ventilation; Movement disorder; Muscular weakness; Myelitis transverse; Nuclear magnetic resonance imaging abnormal	FLU3~SANOFI PASTEUR~U2437AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0297383	11/20/2007	WI	32.0	32		F	11/20/2007	c/o of shortness of breath and itching									Y	11/20/2007	11/20/2007	0		PVT	PUB	patient's usual medications zyrtec,singular,advair, xopenox	asthma, allergic rhinitis	asthma, allergic rhinitis			1						1	Dyspnoea; Pruritus	FLU3~SANOFI PASTEUR~U2445AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297384	11/20/2007	TX	14.0	14		F	11/20/2007	Patient received the FluMist on 10/24/07.  She began having increased coughing shortly after the shot.  She took Claratin as recommended by her physician.  On the a.m. ofo 10/28/07, patient was experiencing mild wheezing but went out of town with her highschool band for a contest.  I was called at 3:00 p.m. and notified that patient was short of breath and wheezing to the point that she was squeeking.  A physician onsite listened to her chest and said she was very restricted and wheezing and recommended using an inhaler.  Patient was then transported to a local clinic.  I was telephoned from the clinic by the physician treating patient who said her oxygen saturation was 92% and that she was very tight in her lungs with significant wheezing.  I spoke with patient and she was barely able to speak.  Patient was given a nebulizer breathing treatment and an injection of Rocephin and Solmedral.  It took over 1 hour for patient's oxygen saturation to raise to 95%.				Y					Y	10/24/2007	10/27/2007	3		UNK	UNK		Patient had been to the physician because of allergy like symptoms with clear lungs and no wheezing or fever	uncertain			1						1	Cough; Dyspnoea; Oxygen saturation decreased; Speech disorder; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500487P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0297385	11/20/2007	CO	60.0	60		M	11/20/2007	Recieved influenza vaccine per IM injection at 10:00AM, 11-2-07. He remained in the building for a meeting.  At approximately 10:30-11:00AM he noted mental confusion but was able to walk to his car.  Upon entering his car, he was diaphoretic and pale but was able to drive out of the parking lot.  Was discovered ~11:20AM (several blocks from vaccine administration site) in his car sitting upright and awake but unable to respond.  Tranported to the ER via ambulance with a blood glucose of 22 upon admission.  Dextrose (Bristoject) administered IV push    X's 2.  Blood glucose after 30 minutes was ~180's.  Blood glucose dropped to ~30 at ~ 12:15PM and he was admitted for observation.  Blood glucose was monitored and remained in 70-160's range through the next day (11-3-07).  He was NPO and maintained on a continuous infusion of D5W.  Blood glucose dropped to 70 at ~noon on 11-3-07 but rose to 90 at ~1:00-2:00PM.  He was discharged from hospital to home mid-afternoon 11-3-07. 11/30/07-records received for DOS 11/02-11/3/07-DC DX: Hypoglycermia. While driving erratcially car stopped and found in car passed out.  No HX of diabetes. Did not eat night before. Day of admission, exercised and received flu shot. One hour later episode occurred.				Y	Y	1			Y	11/02/2007	11/02/2007	0	Full chemistry profile, including C-peptide, upon admission to ER (11:30 AM). Excepting blood glucose, results within normal limits. C-peptide level: neglible.  Growth hormone results pending. After discharge: Glucose tolerance test (including 72 hour fasting) within normal limits; CT scan of abdomen negative for masses/growths/tumors. records received 11/30/07-Glucose 22.	UNK	UNK	Accupril, 20mg daily; Albuterol and Aerobid inhalers PRN asthma flare.  Had not used inhalers prior to receiving vaccine.	NONE	Hypertension, controlled with Accupril records received 11/30/07-PMH:hypertension and asthma. Smokes. Resection of retroperitoneal paraganglioma.			1						1	Blood glucose decreased; Blood growth hormone; Computerised tomogram normal; Confusional state; Glucose tolerance test normal; Hyperhidrosis; Insulin C-peptide; Laboratory test; Pallor; Unresponsive to stimuli	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA028AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation	Influenza
0297411	11/20/2007	VT	30.0			M	11/20/2007	This case was reported by a healthcare professional and described the occurrence of systemic shot reaction in a 30-year-old male subject who was vaccinated with Flulaval for prophylaxis. The subject had no relevant medical history. There were no concurrent medications. No other vaccinations were administered on the date of receipt of Flulaval. The subject had not previously received a flu shot. On 12 November 2007 at 2:00 p.m., the subject received 1st dose of Flulaval (.5 ml, unknown, left arm). On 14 November 2007, 2 days after vaccination with Flulaval, the subject experienced a systemic reaction which included hives, redness and itching. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with Benadryl and Claritin. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Flulaval.				Y					N	11/12/2007	11/14/2007	2	UNK	PVT	PVT	No concurrent medication	Unknown	The subject had no relevant medical history.		A0695439A	1						1	Erythema; Immunisation reaction; Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA032AA~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0297412	11/20/2007	TX	46.0			F	11/20/2007	This case was reported by a physician and described the occurrence of aphasia in a 46-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline). The subject's medical history, concurrent medications were not reported. Information regarding previous immunization with influenza virus vaccine was not provided. The reporting physician did not have the subject's chart with him at the time of the call. On 15 November 2007 at 8:00 a.m., the subject received unspecified dose of Flulaval (.5 ml, unknown). On 15 November 2007, within a few minutes of receipt of Flulaval, the subject became unresponsive. The physician reported that the subject's eyes were open but she was no longer able to speak. The physician described the subject was unresponsiveness or aphaisiac. The subject's vital signs were stable and the subject did not pass out. Emergency medical services was called and the subject was taken to the hospital. The reporting physician has spoken with the emergency room physician and was told the subject was still in this state and they plan to admit her to the hospital. The reporting physician also considered the events to be disabling. At the time of reporting the events were unresolved.				Y	Y	0		Y	N	11/15/2007	11/15/2007	0	Tests: 15 November 2007: The subject's vital signs were stable.	OTH	OTH		Unknown	The subject's medical history, concurrent conditions, and concurrent medications were not reported.		A0695430A	1						1	Aphasia; Unresponsive to stimuli	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation,Disabling	Influenza
0297413	11/20/2007	NY	43.0	43		F	11/20/2007	This case was reported by a consumer and described the occurrence of a burning sensation over the body in a 43-year-old female subject who was vaccinated with (Flulaval, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. On 12 October 2007 at 15:10 the subject received unspecified dose of Flulaval in the left arm. On 12 October 2007, 10 minutes after vaccination with Flulaval, the subject experienced a burning sensation over her body. Other events reported with unspecified time to onset included dizziness, headache (described as sections of her head hurting), fatigue, tingling over the body, glands hurt, breaking out, itching, nausea, internal burning sensation (such that when she exhales she feels that heat is coming out), difficulty breathing, muscle pain, chest pain, cloudy vision and redness and burning of the eyes. The consumer reported that her opthamologist said her corneas were irritated and inflamed. The subject also reported having a stiff neck. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified with the exception of the burning sensation over the body which was unresolved. Reportedly, the subject's physician spoke to an infectious physician and it was noted that gentomycin is in the drug and that the subject could be reacting to that.									U	10/12/2007	10/12/2007	0	UNK	OTH	OTH		Unknown	The subject has not previously received flu vaccines.		A0695209A	1						1	Burning sensation; Chest pain; Dizziness; Dyspnoea; Erythema; Eye irritation; Fatigue; Headache; Keratitis; Musculoskeletal stiffness; Myalgia; Nausea; Ocular hyperaemia; Pain; Paraesthesia; Pruritus; Vision blurred	FLU3~GLAXOSMITHKLINE BIOLOGICALS~053AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0297414	11/20/2007	CA	64.0	64		F	11/20/2007	This case was reported by a consumer and described the occurrence of supraventricular tachycardia in a 64-year-old female subject who was vaccinated with (Fluarix, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. The subject's medical history included allergy to ibuprofen, allergy to vicodin, aspirin allergy, asthma, chronic obstructive pulmonary disease and sulf allergy. Concurrent medications included Salbutamol sulphate (Albuterol), Fluticasone propionate+salmeterol xinafoate (Advair) and Tiotropium (Spiriva). On 13 October 2007 at 13:15 the subject received 1st dose of Fluarix (.5 ml, left arm). On 13 October 2007, less than one day after vaccination with Fluarix, the subject experienced shivering, chills, body aches and muscle aches. On 14 October 2007, the subject experienced nausea. On 16 October 2007, the subject experienced supraventricular tachycardia and wheezing. The subject presented to the emergency room on 16 October 2007, 17October 2007 and 18October 2007. She was taken by ambulance to the hospital on 19 October 2007 and hospitalized in the intensive care unit. Treatment was not specified. She was discharged home on 24 October 2007. The subject considered that the events were jeopardizing or required intervention to prevent a serious outcome. At the time of reporting the outcome of the wheezing, supraventricular tachycardia, shivering and chills had resolved. The outcome of the other events were unspecified.				Y	Y	5			U	10/13/2007	10/13/2007	0	UNK	PVT	PVT	Salbutamol sulphate; Fluticasone-salmeterol; Tiotropium	Unknown	ALLERGY TO IBUPROFEN; ALLERGY TO VICODIN; ASPIRIN ALLERGY; ASTHMA; CHRONIC OBSTRUCTIVE PULMONARY DISEASE; SULFA ALLERGY Subject has not received any previous influenza vaccinations. No adverse events following previous vaccinations.		A0695015A	1						1	Chills; Intensive care; Myalgia; Nausea; Pain; Supraventricular tachycardia; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0297418	11/20/2007	MA	70.0			M	11/19/2007	Information has been received from a physician concerning a male approximately in his early 70's who at 08:00 (date unspecified) was vaccinated with a single dose of Zostavax (Oka/Merck). Concomitant vaccination administered on that same day at 08:00 included a dose of influenza virus vaccine (unspecified). Subsequently the patient experienced trouble urinating from about 12:00 until 04:00 and then fainted. The patient went to the emergency room and was subsequently admitted to the hospital for an overnight stay. The patient was able to urinate around 04:00 and was noted to be recovering. Medical treatment in the hospital was not specified. There was no product quality complaint. Additional information has been requested.				Y	Y	1			N				Unknown	UNK	UNK	Unknown		Unknown		WAES0711USA02963	1						1	Dysuria; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~UN~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Hospitalisation	Influenza
0297421	11/20/2007		3.0	3		M	11/20/2007	We received on 09 NOV 2007 via MedCom US from a nurse the following information: A 3-year-11month-old male patient, born on 06 DEC 2003, was vaccinated i.m. with 0.5 ml Fluvirin, batch no. 80956, on 02 NOV 2007. The patient experienced bronchiolitis and was hospitalised from 05 NOV 2007 to an unknown date. The outcome is unknown. Company assessment: Serious criterion: hospitalisation. Causality: not related. Expectedness assessment according to product information and regulatory agency. Administration to a child under 4 years and bronchiolitis are unexpected after vaccination with Fluvirin. MedCom US no.: NA07-006282					Y	0			U	11/02/2007	11/05/2007	3		OTH	OTH	No other medications	Unknown			MA20071359	1						1	Bronchiolitis; Inappropriate schedule of drug administration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80956~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0297423	11/20/2007	FL	73.0	73		F	11/19/2007	Weakness of lower extremities, pain in back and chest, paresthesias, hospitalized 5 days for Guillain-Barre Syndrome. Rx plasmapheresis.  01/04/2008 MR received for DOS 10/27-11/01/2007 with D/C Dx: Guillain-Barre Syndrome.  Pt presented to ER with c/o progressive weakness and pain in the back x 9-10 days with paresthesias. Pt recently lost bladder and bowel control and was admitted. Txd with plasmapheresis with improvement of sx.			Y	Y	Y	5			N	10/02/2007	10/15/2007	13	Spinal fluid protein elevated. Labs and Diagnostics:  MRI thoracic spine unremarkable.  CSF with protein 76.   3 oligoclonal bands. CSF Albumin 48.8.  CSF IgG Synthesis Rate high @5.0. CSF HSV (-).  CSF culture (-). Serum IgG low at 699.  Myelin Basic protein normal.  Vit B-12 high @ 2368. Abdominal X-ray with mild dilitation of small bowel loop.  CT abdomen with no acute abnormality.  Mild diverticulosis.	OTH	PVT	Calcium citrate; Forteo	None	Osteoporosis. PMH:  degenerative arthritis of the back. NKDA.			1						1	Back pain; CSF protein increased; Chest pain; Guillain-Barre syndrome; Muscular weakness; Paraesthesia; Plasmapheresis	FLU3~SANOFI PASTEUR~U2440AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0297424	11/20/2007	AZ	2.0	2	.3	M	11/19/2007	Per hospital admission note - admitted on 11/17/07 for acute loss of consciousness. 6/23/08-records received for DOS 11/15-11/24/07-DC DX: seizure disorder. Presented with nonconvulsive status epilepticus demonstrated on EEG.				Y	Y	9			U	11/13/2007	11/14/2007	1	6/23/08-records received-Lumbar puncture, MRI showed focal edema and cytotoxic change in mid left thalamus an acute change. Atrophic appearance of right mesial temporal lesion w ith dilatation of temporal horn, EEg show some seizure activity. CSF culture negative. RSV culture negative. Chest x-ray revealed bibasilar consolidation of lungs.	PVT	PVT	Ocuflox; Tamiflu; Carvedilol; Captopril; Protonix; Reglan	None	Developmental delay NOS; Blindness/Low Vision; Prim Cardiomyopathy Nec; GERD;  6/23/08-records received-PMH:congenital dilated cardiomyopathy, developmental delay, G-tube dependent and gastroesophageal reflux.			1						1	Loss of consciousness	FLU3~SANOFI PASTEUR~UT2474CA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0297425	11/20/2007	AZ	2.0	2	.3	M	11/19/2007	Per hospital admission notice - admitted 11/15/07 for seizures. 6/27/08-records received for DOS 11/17-11/25/07-DC DX: Global developmental delay.  Presented with status epilepticus with some desaturation at home, generalized tonic-clonic seizures and decreased responsiveness per parent. Cough and nasal congestion noted. Known seizure disorder.				Y	Y	8			U	11/13/2007	11/17/2007	4	6/27/08-records received-EEG subclinical seizure acitivty without any obvious seizure activitiy. Urine culture negative, blood culture negative, CT no acute pathology, abnormal appearance of lateral ventricles with dilatation of frontal horms and prominent frontal CSF space as well and cerebellar atrophy. BMP normal range.	PVT	PVT	Magnesium Sulfate; Ferrous Sulfate; Reglan; Poly-Vi-Sol; Protonix; Prograf; Sirolimus; Valcyte	None	Compl Heart Transplant; Strabismus; GERD; Microcephalus; Infectious mononucleosis; Developmental delay; Feeding problem 6/27/08-records received-PMH:Cardiac transplant secondary to cardiomyopathy 2/06, congenital dilated cardiomyopathy, G-tube feed, seizure disorder. 37 week twin.			1						1	Convulsion	FLU3~SANOFI PASTEUR~UT2474CA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0297426	11/20/2007	LA	0.53	0	.5	F	11/20/2007	Probable seizure - 12 hours after Pediarix, Rotateq, Prevnar, Flu.  01/09/2008 MR received for DOS 11/20-21/2007 with D/C DX:  Febrile Seizure/UTI. Child presented to ER after seizure episode.  Child had initially woken with T=100.1, given Tylenol but vomited.  Later parent noted staring, tonic-clinic movements,  gasping breaths, and drooling.  Child was unresponsive, later sleepy with decreased activity. D/Cd on abx for UTI. 1/15/2010 The patient continues to be on seizure medication. The neurologist felt not related to vaccinest (thought febrile seizure) but patient continues to have seizures and is on seizure medication.					Y	1			N	11/19/2007	11/20/2007	1	will be admitted for workup. Labs and Diagnostics:  UC (+) with > 100,000 CFU E. coli.  CSF WNL.  CSF cx (-). Blood cx (-).  CBC WNL.  CMP unremarkable.  CT brain WNL.  Abd US WNL.  KUB WNL.	PVT	PVT		None	None. PMH:  heart murmur.			1						1	Convulsion	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B129AA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2460EA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08702E~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0902U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0297428	11/20/2007	GA	65.0	65		F		Woke up during night w/ chills fever. Next morning was achy; tired; headache - stayed on sofa under cover until 11:00 AM; tried to move around; noticed a red spot on arm that shots were given in Thurs afternoon. Applied ice; arm is extremely sore; did not feel like eating; slept a little better Thurs night; moved around some on Fri, still had a few chills; Sat 2:00 PM noticed another large area on arm; applied ice; Sunday AM had a nurse tried look at red spot - she said it was still warm and I should apply heat. Sunday night arm is moving better.									Y	10/10/2007	10/11/2007	1		PUB	PUB		None	None			1						1	Chills; Decreased appetite; Fatigue; Headache; Injection site erythema; Injection site warmth; Pain; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U2440AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0601F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297429	11/20/2007	UT	48.0	48		F	10/12/2007	Swelled up/red/hot to the touch red rash size of a silver dollar or larger hard in the center									Y	10/11/2007	10/11/2007	0		PVT	PVT			aoritc valve replacement			1						1	Induration; Rash erythematous; Skin warm; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78476~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0297430	11/20/2007	CO	40.0	40		F	10/04/2007	patient had freezing cold, all body muscle spasm, Headache, nausea/vomiting for 2 days after pneumonia and flu shot. Pain in R arm and chest, armpit. Bruise on armpit									Y	10/01/2007	10/02/2007	1		OTH	PVT		No	No			1						1	Chest pain; Contusion; Feeling cold; Headache; Muscle spasms; Nausea; Pain in extremity; Vomiting	FLU3~SANOFI PASTEUR~U2488A~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297432	11/20/2007	MT	73.0	73		M	10/14/2007	Swelling and redness of arm in which vaccine was administered (right). Patient went to emergency room as precaution and received Cephalexin.				Y					U	10/04/2007	10/05/2007	1		OTH	PUB	Lovenox 80mg/0.8ml Namenda 10 mg	None	Heart Arrhythmia, Alzheimer's/Dementia			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2453AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1005F~2~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0297436	11/20/2007	KY	87.0	87		M	11/19/2007	none noted or reported by pt- pt received flu vaccine 11-19-07 stated he had received one 3 wk prior									Y	11/19/2007				PVT	PVT		None				1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U2442AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297437	11/20/2007	NY	1.3	1	.3	M	11/20/2007	Pt developed parotitis approx. 7-10 days after MMR vaccine.										11/08/2007	11/15/2007	7		PVT	PVT	None	None	None			1						1	Parotitis	FLU3~SANOFI PASTEUR~UT2474FA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0746U~1~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0297438	11/20/2007	NY	12.0	12		F	11/20/2007	11-20-07 13 y/o female was given Fluarix 0.5 ml IM in (R) arm lot AFLUA282DA Exp 6/30/08. This vaccine is not approved for children < 19 yrs old. No adverse event reported from parent									Y	11/20/2007				PUB	UNK		None				1						1	Inappropriate schedule of drug administration; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA282DA~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0297439	11/20/2007	UT	4.0	4		M	11/16/2007	Red, swollen deltoid, from shoulder to elbow but decreased a lot in redness and size with Benadryl.									Y	11/14/2007	11/15/2007	1		PVT	PVT		None				1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2436AA~3~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297440	11/20/2007	MN	1.8	1	.8	F	11/20/2007	Hives next day after receiving Fluzone .25 ml. Thimerosol-Free									Y	11/19/2007	11/20/2007	1		PVT	PVT		None	None			1						1	Urticaria	FLU3~SANOFI PASTEUR~UT24736A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297441	11/20/2007	TX	62.0	62		M	11/19/2007	Client called on 11/13/07 to report symptoms of urticaria - raised edematous patches of skin with itching noted to (L) upper arm, radiating down back of arm 2 days post-flu vaccination. Did not have fever or other adverse reaction such as: breathing difficulties, wheezing or dizziness. Instructed client to take Benadryl and report to health unit when return to work on 11/14/07. Noted upon assessment, small red bumps to (L) upper arm - no swelling noted since using Benadryl within the last 24 hours. Itching resolved as well.									Y	11/08/2007	11/10/2007	2	N/A	PUB	OTH	HDCT, Travatan, Cosopt, Altazan, Aspirin, Supplements - per pt form	None	Heart murmur - 1952			1						1	Oedema; Pruritus; Rash erythematous; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78994~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0297444	11/20/2007	AZ	6.0	6		M	11/19/2007	Mother states pt's arm became red and warm to touch at injection site on the evening of 11-14-07. Mother states a large red, warm area on his (R) arm was present in the am on 11/15/07, mother also noted and rash around the red area and took pt to the ER-the ER gave the pt Benadryl and sent home Mother states today 11-19-07 that the swelling, redness and heat is gone.				Y					Y	11/14/2007	11/14/2007	0	None	PVT	PUB	Concerta, Lovastatin, Singulair	None	Asthma			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2461BA~6~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297446	11/20/2007	KY	53.0	53		F	11/20/2007	Swelling at site injection, kept getting bigger until went to to ED on 10/28. Patient stated no systemic adverse events. Patients stated doctor diagnosed cellulitis and gave Cefdinir 300 and Clindamycin 300. Patient recovered completely. I never saw patient's arm after giving vaccine.				Y					Y	10/26/2007	10/26/2007	0	Unknown	OTH	PVT	Bactrim DS, Z-Pak	Unknown	None			1						1	Cellulitis; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79240~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0856U~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0297447	11/20/2007	MN	41.0	41		F	11/16/2007	Client called at 14:45 c/o heart racing and mild shortness of breath 30 min after receiving vaccine. These sx subsided and was c/o of fatigue, body aches and head cold/congestion sx.									N	11/16/2007	11/16/2007	0		PUB	PUB	None	No	None			1						1	Dyspnoea; Fatigue; Nasal congestion; Nasopharyngitis; Pain; Palpitations	FLU3~SANOFI PASTEUR~U2511AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297448	11/20/2007	NY	1.2	1	.2	F	11/20/2007	Fluzone administered 0.25 ml I.M. left thigh 11/19/07 9:32 am. 11/20/07 2 PM - Hives noted for the first time on lt. thigh, trunk and extremities, no other respiratory s/s. No breathing difficulties, alert, active, playful, not any distress. Benadryl (12.5 mg) 1 tsp PO tid x 24 hours, then as needed.									Y	11/19/2007	11/20/2007	1	None	PVT	PVT	None	None	11/14/07 S/P bilaterally otitis media, Motrin Rx			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2469AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297449	11/20/2007	MD	55.0	55		F	11/20/2007	Pt c/o arm received vaccine in (L) felt wobbly-like Jello and (L) side of face felt tingly. Pt states she had hot flash and it was already hot inside building and she got nervous. States I know I'm nervous because I can feel it in my stomach. No rash, no breathing probs, no other symptoms.									Y	11/20/2007	11/20/2007	0	0938 BP = 142/90; 0950 BP = 150/88; 1000 BP = 140/86; 1015 BP = 144/84	PUB	PUB	Unknown	None noted	None noted			1						1	Blood pressure; Dizziness; Hot flush; Nervousness; Paraesthesia	FLU3~SANOFI PASTEUR~U2475JA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297450	11/20/2007	NE	25.0	25		F	11/20/2007	Administered 11/19/07 at 1500. started itching on arms at 1700. By 2100 had hives whole body even on scalp. Took 25mg Benadryl PO went to bed. 11/21/07 Woke up swollen lt lip and lt cheek. No edema at site lt deltoid, swollen area numb and tingling. No throat or resp problems at all. Lt side of face and lips still swollen at 0930.										11/19/2007	11/19/2007	0	None	PVT	UNK	None	No	No			1						1	Hypoaesthesia facial; Lip swelling; Paraesthesia; Pruritus; Swelling face; Urticaria	FLU3~SANOFI PASTEUR~U2457HA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297451	11/20/2007	CO	4.0	4		M	11/19/2007	local rxn to flu vaccine requiring U.C visit 2d after flu shot administered. Tx'd by U.C. doctor & Amoxicllin				Y					Y	11/09/2007	11/11/2007	2		PVT	PVT		None	None			1						1	Local reaction	FLU3~SANOFI PASTEUR~U2490AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297453	11/20/2007	MN	0.5	0	.5	M	11/20/2007	Pt developed a fever the evening after receiving his routine 6 month immunizations and his first influenza vaccine. Then he had a prolonged SZ. ER W/U: negative. Sent home.				Y					Y	11/09/2007	11/10/2007	1	CBC: WNL, CSF: WNL (Cx: (-) Blood Cx: (-) Urine Cx: (-)	PVT	UNK		None	None			1						1	Blood culture negative; CSF test normal; Convulsion; Culture urine negative; Full blood count; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B124DR~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2473HA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08700K~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~U239U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0297454	11/20/2007	MO	27.0	27		F	11/15/2007	approx 1/2 hour after injection, pt reports she had (L) raw numbness and twitching for approx 15-20 min. On 11-8-07 pt seen in ER for cough, fever, increased dyspnea. Dx with Bronchitis, pneumonia bronchospasm									Y	11/07/2007	11/07/2007	0	Influenza A/B-negative	PVT	PVT		cough, no fever	None			1						1	Bronchitis; Bronchospasm; Cough; Dyspnoea; Hypoaesthesia; Influenza serology negative; Muscle twitching; Pneumonia; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80684~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0297457	11/20/2007	MA	57.0	57		F	11/19/2007	increased swelling pain given Levaquin 750 11/19/07 better/can use hand slightly/not as red									Y	11/13/2007	11/16/2007	3		PVT	PUB		No				1						1	Erythema; Swelling	FLU3~SANOFI PASTEUR~U2524AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1229F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297367	11/21/2007	PR	64.0	64		F	11/21/2007	Patient arrived to the hospital on 11/03/2007 complaining of epigastric pain and weakness of the lower extremities. On 11/12/2007 patient developed respiratory distress and was intubated. Patient was transfered to ICU intubated, lethargic and unable to move upper and lower extremities.					Y	18	Y		U	10/23/2007	11/03/2007	11	CSF- Gram Stain-No bacteria seen, Protein (CSF)-268.2, Glucose(CSF)-172. India Ink-negative CMV IgM-0.52,CMV IgG-256.7, EBV VCA AB IgG-6.2, EBV VCA AB IgM-0.05	UNK	UNK	Oxycontin, Neurontin,Lyrica		Diabetes,Neuropathy			1						2	Asthenia; Guillain-Barre syndrome; Intensive care; Mechanical ventilation; Respiratory failure; Abdominal pain upper; CSF glucose increased; CSF protein increased; Cytomegalovirus antibody; Epstein-Barr virus antibody; Gram stain negative; Intensive care; Intubation; Lethargy; Movement disorder; Muscular weakness; Respiratory distress	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80063~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80063~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Hospitalisation	Influenza
0297504	11/21/2007	NY	4.0	4		M	11/21/2007	None. Vaccine not approved for age group.									Y	11/09/2007	11/14/2007	5	none	PVT	PVT	Zyrtec, Singular	none	Asthma	none~ ()~0~~In Patient		1						1	Inappropriate schedule of drug administration; Medication error; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AfluA317AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0297505	11/21/2007	NY	4.0	4		F	11/21/2007	None. Vaccine not approved for age group.									U	11/08/2007	11/19/2007	11	None.	PVT	PVT	None	None	None			1						1	Inappropriate schedule of drug administration; Medication error; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AfluA317AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0297506	11/21/2007	SC	61.0	61		F	11/21/2007	The evening of the day of the vaccine, I began to feel achy, more so in my neck, but generally all over. The following day, I had fever, chills, hoarseness and my throat felt 'swollen', and again had aches all over my body.									Y	11/19/2007	11/19/2007	0	none done	UNK	PVT		none	none			1						1	Chills; Dysphonia; Neck pain; Pain; Pharyngeal oedema; Pyrexia	FLUX~UNKNOWN MANUFACTURER~CP code G0008~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0297507	11/21/2007	NY	10.0	10		M	11/21/2007	None. Vaccine not approved for age group.									Y	11/08/2007	11/19/2007	11		PVT	PVT	none	none	Allergies to rice, green beans, concerta			1						1	Inappropriate schedule of drug administration; Medication error; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AfluA317AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0297508	11/21/2007	MD	26.0			F	11/21/2007	Headaches, nasal congestion, fatigue, sore throat, lightheadedness began 1 day after receiving FluMist vaccine, persisting at day 5 post dose.									U	11/17/2007	11/18/2007	1	None	MIL	MIL	None	None	None			1						1	Dizziness; Fatigue; Headache; Nasal congestion; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~UNK~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0297510	11/21/2007	NY	86.0	86		M	11/21/2007	Pt developed vesicular rash on the same arm that he received the flu vaccine, 2 days after receiving vaccine. Pt did not report rash until 11/15 and presented to office on 11/20. Pt diagnosied with Shingles and started on valcyclovir 1g tid.  Pt with vesicular rash over entire Right arm and scapula region				Y					U	11/05/2007	11/07/2007	2		PVT	UNK	atenolol 50mg daily, glyburide 5mg daily, simvastin 40mg dialy, terazosin 5mg bid, normvasc 10mg daily, cardura 1mg daily, januvia 50mg daily	None	Type II diabetes mellitus, hypertension, hypercholesterolemia, BPH,CHF systolic, pascemaker			1						1	Herpes zoster; Rash vesicular	FLU3~SANOFI PASTEUR~U2529AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297512	11/21/2007	NY	15.0	15		F	11/21/2007	None. Vaccine not approved for age group.									Y	10/04/2007	11/19/2007	46		PVT	PVT	Albuteral, Pulmicort, Singular, Allegra	None	Asthma			1						1	Inappropriate schedule of drug administration; Medication error; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~UfluA208DA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0297513	11/21/2007	NY	11.0	11		M	11/21/2007	None. Vaccine not approved for age group.									Y	11/06/2007	11/19/2007	13		PVT	PVT	None	None	Asthma			1						1	Inappropriate schedule of drug administration; Medication error; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AfluA280DA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0297514	11/21/2007	AZ	4.0	4		F	11/21/2007	Redness at injection site. Slight swelling, warm to touch, slightly tender. Started looking like cellulitis, given Keflex 250mg/5ml 5ml tid 10 days.									Y	11/15/2007	11/16/2007	1		PVT	PVT	n/a	n/a	n/a			1						1	Cellulitis; Injection site erythema; Skin warm; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U2490AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297515	11/21/2007	OK	0.25	0	.3	F	11/21/2007	No adverse events per parent - contacted on afternoon 10/31/2007. Reporting due to Influenza Vaccine administered before 6 mo. of age per recommendation of CDC Info. Contact Service #1-43674577.									Y	10/30/2007			None	PVT	UNK	None Known	None Known	None Known			1						1	Inappropriate schedule of drug administration; Medication error; Wrong drug administered	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~~1~UN~~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2508AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~UNKNOWN MANUFACTURER~~1~UN~~HIB (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~UN~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0297517	11/21/2007	SD	7.0	7		M	11/21/2007	11-15-07 1553 Client received flu shot at 1553 Sanofi Lot U2502AA in left deltoid IM.  11-19-07 Mom came into office in afternoon and told clerical the patient had to go to the Dr. on Saturday November 17, 2007 because the spot where he got the flu shot was all red.  The Dr. told her it was an infection.  11-20-07 1120 Left message at client's house for mom to return my call and let me know details of what happened. 11-20-07  Saw client's mom in evening at flu clinic and she reported details to me.  She stated on Friday November 16 her son (client) told her that his arm itched.  On Saturday November 17 her son was getting dressed and felt a bump on his arm.  He went to show his mom and she stated it was red, warm and sore.  No fever was present.  Mom felt the redness was the size of an orange or a grapefruit.  She took him to acute care in the am and he saw a PA.  He was given an antibiotic.  Mom is unsure of the name but knew it started with a 'C'.  He was prescribed 10 days worth for three times a day.  She gave him two doses on Saturday and by Sunday the redness was the size of a dime.				Y					Y	11/15/2007	11/17/2007	2	NA	UNK	UNK	None	None	None			1						1	Infection; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~U2502AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297519	11/21/2007	CA	48.0	48		F	10/31/2007	Patient presented to clinic with the following adverse drug reactions; injection site of her right upper arm began to hurt at night,swell, and became red.  Patient received tetanus vaccine and flu or pneumovax.  Unknown if patient received the vaccination at clinic.									Y	10/30/2007	10/30/2007	0		UNK	UNK						1						1	Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0297521	11/21/2007	AK	23.0	23		F	11/21/2007	severe myalgias at night and in am after vaccine, resulting in muscle cramping of hands and feet and locking of ankles and elbows. Upon waking in am was so impaired that she had to crawl to phone but regained mobility within 1/2 hour.  Function nl by 24 hours, Sx resolved by 36 hours									Y	10/16/2007	10/17/2007	1		PUB	PUB						1						1	Mobility decreased; Muscle spasms; Myalgia	FLU3~SANOFI PASTEUR~U2443AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297522	11/21/2007	MN	40.0	40		F	11/21/2007	Received IM vaccine 11/09.  Had latent side effect on 11/13 - noted hard redden area surrounding injection site, the size of a  quarter, swollen and raised.  Referred to MD. MD ordered oral antibiotics and administered 2 Rocephin IM's. Diagnosis of cellulitis. 11/14 noted increased swelling, redden rash radiated down the biceps.  Admitted patient for IV antibotic therapy vancomyacin.  Hospitalized 2 days.  Taken off vancomyacin as of 11/21/07.  Will continue on oral antibotics.  The right deltoid is still visabily slightly redden and swollen; the muscle feels somewhat harder than right deltoid muscle and has one minute areas of serous leakage which is covered with a bandaid.   No tunneling.  Pain has alleviated and is only noted in right upper deltoid.  ROM normal today.  Will continue monitoring of site and stay on oral antibotics12/3/07-records received  for DOS 11/14-11/16/07-DC DX: Right upper arm cellulitis. Increasing redness and swelling and pain.					Y	2			Y	11/09/2007	11/13/2007	4	cellulitis 12/3/07-records received- Blood cultures no growth WBC 13.8, neutrophil% increased 84, absolute neurtrophils increased 9.2, lymphocyte% decreased 7. Ultrasound right proximal humerus at site of flu shot:diffuse soft tissue edema and swelling probably due to cellulitis. CT upper extremity: inflammation of subcutaneious tissue adjacent to the right deltoid muscle, consistent with cellulitis.	UNK	UNK		Had previously cut her finger in ER	unknown 12/03/07-records received-PMH: skin abscesses, depression, esophageal reflux.			1						1	Cellulitis; Erythema; Injection site cellulitis; Injection site discharge; Injection site erythema; Injection site induration; Injection site swelling; Muscle tightness; Pain in extremity; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua319aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0297523	11/21/2007	UT	21.0	21		F	11/21/2007	Approx. 1-2 hrs after flu vaccine, employee noticed arm where vacccine administered itching, then became aware of itching, stinging rash over entire body.Sts fever next day, abd discomfort since onset.Employee seen 5 days after symptom onset-treated with tapering dose Prednisone, Zantac OTC suggested.Offered eval by Wrk Md.11/20/07, empl. chose to come here to Empl. Health office.									U	11/16/2007	11/16/2007	0		PUB	UNK	An antiinflamatory	Experiencing some 'kidney problems'	Unknown			1						1	Abdominal discomfort; Burning sensation; Injection site pruritus; Pyrexia; Rash generalised	FLU3~SANOFI PASTEUR~U 2497 AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297568	11/21/2007	MD	7.0	7		F	11/21/2007	Within a week of the vaccination, she was tired, and she had a few nose bleeds (that were hard to stop). Her gums started bleeding when brushing her teeth a few weeks after the vaccine. She then started having high fevers around October 31, 2006,(103, 104, 105)and was eventually hospitalized on November 7, 2007, after a blood test revealed that her blood platelet count was down to 16,000. She had two chest x-rays that were normal. She was diagnosed as having high fever, a low platelet count (platelets got as low as 7,000), and low red blood cells count (which resulted in anemia). While hospitalized, she was twice treated with IVIG that caused her platelet count to rise. She also received intravenous antibiotic treatments that she did not respond to. She was also given Tylenol and later Motrin while hospitalized to control the fever. She is now taking Prednisone for a short period. In addition, she is taking iron pills and Protonix (to protect her stomach from the affects of the steroid medicine). While hospitalized, she also had a CAT Scan (of the head) and ultrasounds of her abdominal area (tests were normal).  12/06/2007 MR received for DOS 11/7-17/2007 with D/C DX:  Evan's Syndrome. Presented to local ED with fever x days, thrombocytopenia and anemia. Pt initially developed cough, rhinorrhea, fatigue and fever. Treated symptomatically for suspected viral infection.  Pt developed increasing fatigue and difficulty leaving bed.  Seen again by PCP with labs and CXR done.  Admitted for further w/u of FUO and thromobcytopenia.  PE (+) for purpura of the external ear, lip ecchymosis (blood blisters), violaceous scaly skin patches involving the malar eminence, and upper extremities. Started on abx and IVIG PMH: Skin disorder x 1.5-2 yrs c/w granuloma annulare.  Rash on face/cutaneous lesions c/w Lupus.  Constipation.  Recurrent sinus infections. Pt developed nausea, dizziness and blurred vision and had a near syncopal episode.  New onset RUQ pain on day 8 with increased LFTs.  Multiple consults by Heme/Onc, Rheum, GI, Neuro and ID. DX of Evan's Syndrome on Day 10 and tx with steroids begun to be continued and F/U as outpt. Per 60 day follow up: She is still experiencing low platelets, which is being controlled by steroid usage (presnisone). 1/15/2010 Patient rec'd other vaccine, hep A on 7/31/08 and she had to be readmitted to the hospital she experienced hair loss, skin rash, fevers, low plackets and joint pain.			Y	Y	Y	11			N	10/06/2007	10/31/2007	25	She was admitted to the Hospital on November 7, 2007. She was tested for everything from cancer to lupus, of which all tests were negative. She also was tested for infectious diseases and several viruses, that also had negative results. She had a chest x-ray before being hospitalized on Tuesday, November 6th. She had another chest x-ray on Wednesday, November 7, at Hospital - both results were normal.  Labs and Diagnostics:  CBC with WBCs 8.7, H/H 10.5/31.9, platelets 16,000. CMP with Na 133, AST 81-314, ALT 34-64.  LDH 606-1024.  Platelets down to 7,000.  Sed rate 71. UA (+) for sediment.  Blod cx (-).  Lupus labs (ANA, ds DNA, anti-Sm, RNP, SSA, SSB) all (-). CK 893, complement WNL. PT 16.7, UA with trace protein, EBV IgG (+). CMV IgG and IgM (+).Head CT (-).  Abd US and doppler shows thin renal parenchyma of the R kidney maybe 2' to pyelonephrotic scarring, normal liver.	UNK	UNK	children vitamins	none	granuloma annularre (skin condition), seasonal sinus problems			1						1	Alopecia; Anaemia; Arthralgia; Chest X-ray normal; Computerised tomogram normal; Constipation; Epistaxis; Fatigue; Gingival bleeding; Granuloma annulare; Immunoglobulins; Laboratory test; Laboratory test normal; Lip blister; Platelet count decreased; Pyrexia; Rash; Red blood cell count decreased; Skin exfoliation; Syncope; Ultrasound abdomen normal; White blood cell count	FLU3~SANOFI PASTEUR~~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~ALTAVB207AA~UNK~IM~~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~11830 7/24/09~UNK~SC~~VARICELLA (VARIVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0297570	11/21/2007	AR	5.0	5		F	11/21/2007	approximately 10 days after influenza vaccine developed Headache, lassitude and fever to 104 and then mental status changes. Currently intubated with questionable early ADEM in our PICU. 12/10/07-interim records received-patient remains in hospital. DOS 11/20/07-altered mental status. Since Sunday, fever, then sleepy, clenching teeth for several days and unable to take oral medications. Unresponsive with short intermittant eye opening since Sunday.  In route to hospital had a 10-15 minute period of lost of consciousness and coded. PE: eyes fixed to left, teeth clenched, deceribrate posturing, unresponsive to painful stimuli, intermittently whimpers. Intubated.  2/5/08-DC summary received for DOS-11/20-12/27/07-DC DX: Hyper-IgE versus acute disseminated encephalomyelitis. Status epilepticus. Dishcarged to rehab.  Withdrawal symtpoms from Ativan with tachycardia. Per 60 day follow up: Partial recovered from the events. Pt remain on steroids, TRILEPTAL & KEPPRA but is now back in school. Lots of weight gain from steroids.			Y	Y	Y	35	Y			11/08/2007	11/18/2007	10	MRI-questionable early ADEM.  CT normal. LP normal. EEG no clearly defined seizure. PCR for enterovirus and HSV negative. Normal LFTS. 12/20/07-records received-CT scan neg, negative EEG. 2/5/08-records received-MRI 11/21/07-left signal abnormality involving bilateral white matter as well as right perietal gray matter and bilateral thalamic involvement. Repeat MRI 11/26/07-mild increase in size of ventricles and patchy areas of signal intensity and restricted diffusion bilaterally left greater than right suggestive of white matter ischemia injury. LP elevated white blood count.	UNK	UNK		no	none			1						1	Computerised tomogram normal; Electroencephalogram normal; Fatigue; Headache; Intensive care; Intubation; Leukoencephalomyelitis; Liver function test normal; Lumbar puncture normal; Mental status changes; Nuclear magnetic resonance imaging abnormal; Polymerase chain reaction; Pyrexia	FLU3~SANOFI PASTEUR~U2514AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0297673	11/21/2007	PA	52.0	52		M	11/21/2007	245 hours after vaccine pt complained of swelling in jaw									U	11/20/2007	11/21/2007	1		PUB	UNK	na	none	pt had a previous seizure but doctor okd flu shot per pt 11-20-07			1						1	Jaw disorder; Swelling	FLU3~SANOFI PASTEUR~u2492aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297676	11/21/2007	CA	52.0	52		F	11/21/2007	Patient's L arm became very sore the day after she got the shot.  She became itchy all over her the body the next day. She took benedryl for the itching and it stopped but the arm soreness never did go away, even though approximately two weeks have lapsed since she got the shot.She stated that she has been getting the flu shots for many years and has never had a reaction before.									U	10/30/2007	10/31/2007	1		PUB	PUB	Unknown	None	PCN, Morphine. Codeine, ACE Inhibitors			1						1	Injection site pain; No reaction on previous exposure to drug; Pruritus generalised	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79489~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0297677	11/21/2007	AK	48.0	48		M	11/21/2007	Pt. complained of fever, chills and body aches lasting approximately 24 hrs.									Y	11/20/2007	11/20/2007	0		PUB	UNK						1						1	Chills; Pain; Pyrexia	FLU3~SANOFI PASTEUR~u2513aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297678	11/21/2007	CA	6.0	6		M	11/21/2007	11-21-07 Suddenly developed diffused eryth. rash ears, neck, and upper chest 5 min. post receipt of  vaccines. There were also few papular rash over the upper chest.  Rash gradually resolved  over 15-20  min. Left clinic without rash. No SOB, itching, no swelling of  lips. RX Benadryl 25 mg po now, 911 if dec. severe symptoms AD.									Y	11/21/2007	11/21/2007	0	none	PUB	PUB	none	none	none			1						1	Erythema; Rash erythematous; Rash papular	DTAP~SANOFI PASTEUR~U1965AB~2~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2502AA~1~ID~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB288AA~1~IM~RA~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB181AA~1~ID~LA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~A0170~2~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0182U~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1359U~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0297680	11/22/2007	AL	33.0	33		F	11/22/2007	Immediately after receiving the vaccination, I felt very nauseated and dizzy.  I left work early to go home because I was not feeling well. Later, that day I was very, very hoarse, with a very sore throat. I took the afternoon off and purchased some over the counter sore throat medicine and took some Benadryl Allergy Sinus Medicine.  Thanks to the vaccination I missed the Thanksgiving holiday.									Y	11/21/2007	11/21/2007	0		PUB	PUB	None	No	None			1						1	Dizziness; Dysphonia; Malaise; Nausea; Pharyngolaryngeal pain	FLUX~UNKNOWN MANUFACTURER~unknown~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0297681	11/22/2007	MA	54.0	54		M	11/22/2007	Sever rashes covering legs and arms developed over the two weeks following influenza immunization.  Treatment included Prednisone (80gs/day).				Y					Y	11/01/2007	11/03/2007	2		PUB	UNK	None	None	Penicillin	None~ ()~NULL~~In Patient		1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0295915	11/23/2007	MA	1.2	1	.2	M	11/19/2007	Seriousness criteria: Other-Medically Significant Initial report received from a health care provider on 08 November 2007. A 14-month-old male patient with a history of one febrile seizure, had received a right arm intramuscular injection of ActHIB, lot number UF195AA, and a left arm intramuscular injection of Fluzone No Preservative 2007-2008, lot number U2479AA, and a left arm subcutaneous injection of MMR manufactured by Merck, lot number 0183U and a right arm intramuscular injection of Pneumo (Prevnar) manufactured by Wyeth, lot number B47442E on 05 November 2007 at 09:30AM and later that evening, he developed a fever (temperature not specified) and experienced a febrile seizure. The event required a doctor visit or emergency room visit (not specified ) and experienced a febrile seizure. The event required a doctor visit or emergency room visit (not specified at the time of the report). The patient recovered from the event. The patient's history included one febrile seizure which occurred on 12 October 2007. No further information was provided.				Y					Y	11/05/2007	11/05/2007	0	Not reported	PVT	OTH			The patient had not been ill at the time of vaccination. The patient had a history of one febrile seizure which occurred on 12 October 2007.		200703804	1						2	Febrile convulsion; Pyrexia; Condition aggravated; Febrile convulsion; Pyrexia	FLU3~SANOFI PASTEUR~u2479aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~UNKNOWN MANUFACTURER~uf195aa~4~IM~RA~HIB (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0183u~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~b47442e~4~IM~RA~PNEUMO (PREVNAR)~1|FLU3~SANOFI PASTEUR~U2479A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~SANOFI PASTEUR~UF195A~4~IM~RA~HIB (ACTHIB)~2|MMR~MERCK & CO. INC.~0183U~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~2|PNC~PFIZER\WYETH~B47442E~4~IM~RA~PNEUMO (PREVNAR)~2	USA	Emergency room visit	Influenza
0296318	11/23/2007		67.0	67		F	11/20/2007	Information has been received from a PharmD concerning a 67 year old female with arthritis who on 09-NOV-2007 was vaccinated intramuscularly in the deltoid muscle with 0.5ml Pneumovax 23 (lot# 9064U) and a influenza virus vaccine (manufacturer unknown) in the same arm but at a different site. Concomitant therapy included nabumetone (RELAFEN) and fosinopril sodium (MONOPRIL). Later in the day on 09-NOV-2007, the patient experienced pain and limited mobility in arm. The reaction became progressively more severe over the weekend. PharmD advise the patient to go to Urgent care. The patient was unable to be seen at Urgent care and took Ibuprofen, nabumetone (RELAFEN) and used a heating pad for symptomatic relief. The PharmD had not spoken with the patient since the weekend therefore the patient's outcome is unknown at the time of this report. The pharmD felt that the patient's pain and limited mobility in the arm were considered to be disabling. Additional information has been requested.				Y				Y	U	11/09/2007	11/09/2007	0	Unknown	OTH	OTH	MONOPRIL; RELAFEN	Arthritis			WAES0711USA02626	1						2	Heat therapy; Mobility decreased; Pain in extremity; Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2487aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~UNK~IM~UN~PNEUMO (PNEUMOVAX)~2	USA	Disabling	Influenza
0297556	11/23/2007	NJ	4.0	4		M	11/19/2007	This case was received from a health professional on 07 November 2007. Seriousness Criteria: Other-Medically Significant A four-year-old male patient with no reported medical history received Fluzone (lot number U2448AA) on 23 October 2007; route and site were not reported. Within ten minutes of vaccination, the patient developed stridor and sternal retractions while still at his physician's office. He was treated with oxygen, breathing treatment, steroid injection, and Benadryl. He fully recovered after approximately 90 minutes. Per the reporter, the patient had received Fluzone in previous years. No additional information was provided.				Y					Y	10/23/2007	10/23/2007	0		PVT	OTH			Not reported.		200703802	1						1	Intercostal retraction; Oxygen supplementation; Stridor	FLU3~SANOFI PASTEUR~U2448A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297557	11/23/2007	OH	80.0	80		F		I had the shot on Friday, Oct 19th in the am- I went to turn over and got terrible pain in left chest-back and arm. Went to the hospital at 2:00 pm and was released from the hospital the following Tuesday at 2:00 pm.  01/02/2008 MR received for DOS 10/21-23/2007 with  dx chest pain likely costochondritis vs muscle strain. Pt initially noted sharp pain and pressure over L breast.  Pain radiated into L arm to elbow. Pain also noted in back and L side.  No other sx (SOB, diaphoresis, nausea etc) noted.  Pain improved with heat and Motrin.  PE (+) for tenderness to palpation along L breast and L lateral chest wall. (+) Alopecia x 1 yr, (+) dark pigmentation on cheekbones and under eyes. Dry mucous membranes.				Y	Y	2			N	10/19/2007	10/21/2007	2	Chest X-rays, stress test, blood tests, EKG.  Labs and Diagnostics:  EKG w/u evidence of acute ischemia.  Cardiac enzymes (-). Stress Echo with no evidence for ischemia.  CXR normal	PVT	PVT	BENICAR 20 mg; YALATAN - RESTASIS	None	Sulfa - high blood pressure, Arthritis, Glaucoma. PMH:  HTN, bil hip replacements, glaucoma, s/p hernia repair.  Allergy to sulfa.			1						1	Back pain; Blood test; Cardiac stress test; Chest pain; Electrocardiogram; Pain in extremity	FLU3~SANOFI PASTEUR~U2493AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0297562	11/23/2007	WI	3.0	3		M	11/16/2007	Child sleeping in car seat - quickly went unconscious as his mother observed - taken to ER - had seizures x 2. Diagnosed with new onset epilepsy by Dr. Meds: Trileptal, Clonazepam; Diastat prn.   12/4/07 Reviewed hospital medical records which reveal patient experienced unresponsiveness.  Seen at outlying ER where clonic seizure activity was noted.  Transferred to higher level of care.  Tx w/antiseizure meds FINAL DX:cryptogenic complex partial seizure disorder stable on meds.			Y	Y	Y	4			Y	11/07/2007	11/11/2007	4	Blood & urine negative for toxicology; MRI, CAT scans negative; EEG - within normal. LABS: from outlying hospital CT, chemistry, CBC & EEG.  Head MRI WNL.  Continuous EEG monitoring revealed abnormalities.  D/C to home on antiseizure meds w/ped neuro follow up & scheduled for repeat EEG & labs in 2 mos.	PUB	PUB		none	Inguinal hernia surgeries x 2 June 2007			1						1	Blood test normal; Computerised tomogram normal; Convulsion; Epilepsy; Loss of consciousness; Nuclear magnetic resonance imaging normal; Toxicologic test normal; Urine analysis normal	FLU3~SANOFI PASTEUR~U247GA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B47442B~1~UN~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1029U~1~UN~LL~VARICELLA (VARIVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0297563	11/23/2007	AZ	78.0	78		F	11/15/2007	Within 2 hrs. I began to feel ill, weakness, chest pain, nausea, extreme headache, body aches, chills and fever, sores in mouth. Very ill for several days. Went to ER on 10/20, again on 10/25. Temperature at that time was 104.5, BP 200+. Stayed overnight. As of 11/15/07 still have not regained strength or appetite.  12/10/2007 MR received for o/n stay10/24-25/2007 with DX: Acute Febrile Illness, assoc with malaise, myalgias, and arthralgias.  Probably a systemic viral illness.  Essential HTN.  Mild dehydration.  Chronic headaches.  Allergies to Stadol, Demerol, and Inderal.  Remote hx of melanoma.  S/P appendectomy.  Post-menopausal osteoporosis. Pt presented to ER with several day hx of fever, feeling poorly, with generalized myalgias, arthralgias, and malaise.  Pt also reports some non-exertional chest tightness. PE (+) for decreased skin turgor and dryness. Admitted for hydration and anti-pyretics with DX High fever, no obvious source, recent influenza vaccination.				Y	Y	1			Y	10/18/2007	10/18/2007	0	Labs and Diagnostics:  CBC with WBCs 4, 800.  BMP WNL except glucose 108.  CXR shows no acute disease.	PUB	PUB	YERAPAMIL 360, NEXIUM 40, FIORICET/CODEINE, CEFLEX, CENTRUM SILVER, TUMS	None	high blood pressure, migraine, osteoporosis, arthritis. PMH:  essential HTN.  Appendectomy.  Chronic headaces. Dyspepsia.  melanoma.			1						1	Anorexia; Asthenia; Body temperature increased; Chest pain; Chills; Headache; Malaise; Nausea; Pain; Pyrexia; Stomatitis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA302AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0297565	11/23/2007	TX	55.0	55		M	11/22/2007	Miller - Fisher Syndrome. Respiratory failure.  12/07/2007 MR received for DOS 11/18-29/2007 with DX:  Miller-Fisher Syndrome.  Pt expired on 11/29/2007.  Progress note 11/28/07 states  diagnosis of brain death due to massive intracranial hemorrhage. Pt presented to ER on 11/18/07 with fever and progressive lower extremity weakness and swelling of the R side of face associated with weakness and numbness.  Admission PE (+) for multiple superficial skin ulcers, bilateral conjunctival hemorrhage R>L, L eyelid ptosis, R-sided facial weakness motor function 2/5 in lower extremities and nystagmus. Neuro consult  11/19/07 reports that pt developed double vision, trouble walking, and weakness 2 weeks s/p vaccination.  PE (+) for 3rd and 6th cranial nerve palsy, ataxic gait, and absent DTRs. No respiratory problems at that time. Later that day pt developed agonal respirations and respiratory distress and mental status changes. Dx: Acute Respiratory Failure. Intubation was attempted and pt placed on ventilator.  On 11/22/07 pt developed fever and started on abx. By 11/23/07 pt was unresponsive and developed myoclonic activity.  On 11/29/07 pt was removed from life-support with dx of brain death due to massive intracranial hemorrhage. 12/07/2007 Death summary received as above.  Final DX:  Massive cerebrovascular accident with subarachnoid hemorrhage.  Brain dead with flat EEG and (+) apnea test.  Bactermia with enterococcus faecalis and coagulase-negative staphylococcus.  S/P comatose state.  Miller Fisher Syndrome on admission.  pemphigus vulgaris. S/P respiratory failure.  01/11/2008 Death Cert received.  Immediate COD:  Cerebrovascular Accident-Approximate interval:onset to death-hours.  Ascending Polyneuropathy-onset to death: days.  Pemphigus-onset to death:  years.	Y	11/29/2007	Y		Y	11	Y		U	10/31/2007	11/13/2007	13	CSF; Protein/negative cxs.  Labs and Diagnostics:  CBC with WBCs of 16.1.  PT/INR WNL. Head CT with no acute pathology on 11/18/07. MRI brain 11/19/07  with no evidence of acute pathology. CT brain scan 11/26/07 shows subarachnoid hemorrhage with diffuse cerebral edema, possible cerebellar tonsil herniation.  Dopplar studies of the lower extremities WNL.  Initial Chemistry with low Na+, Cl-, and Albumin 3.1 and glucose of 183.  LFTs WNL on admission elevated by 11/25/07 (AST 67, ALT 120, Alk Phos 137, Total Protein 9.0 and Albumin 2.2). Sed rate 38.  CSF protein  75.4. CSF Bacterial antigens (-). Initial Blood cultures (-).  Later blood cultures (+) for Enterococcus fecalis.CSF cultures (-). UC (-).  Cardiac enzymes unremarkable. ANA (-). Lyme and VDRL (-).  CXR initially WNL later showed a L pleural reaction. EEG showed no cerebral activity.	PVT	PVT		Pemphigus Vulgaris.  PE (+) for Pemphigus lesions, and thrush.  Of note, CBC on date of vax with WBCs of 16.4 (low Eos 0.10%, lymph 4.0%, monos 4.40% and high neu 90.9%).	PMH:  Pemphigus vulgaris on long-term steroids.			1						1	CSF culture negative; CSF protein increased; Miller Fisher syndrome; Respiratory failure	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA043AA~UNK~SC~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0964U~UNK~SC~UN~PNEUMO (PNEUMOVAX)~1	USA	Results in Death	Influenza
0297567	11/23/2007	AZ	4.0	4		M	11/23/2007	Developed fever 10/24/07. Seizures 11/6/07. Hospitalized in PICU 11/6 - 11/16/07. Diagnosis viral encephalopathy and seizures.  11/07/2007 MR received for an ER visit 11/2/2007 and admission DOS 11/06-16/2007 with a Primary DX: Viral Encephalopathy.  2' DX:  Seizures. Child initially presented to ER on 11/2/07 with c/o increased sleepiness, low grade fever. Pt had had abdominal pain and fever a few days ago but this was resolving. Pt lethargic and difficult to arouse on PE. DX: Hypoglycemia.  Dehydration. Given IVF with dextrose which perked pt up and pt was D/cd. Returned to ER on 11/6/07 with c/o R-sided convulsions where the head deviated to the L.  Pt had been experiencing some bizarre behaviors in recent days.  Pt was unresponsive upon EMS arrival and continued to have seizure activity in ER.  Upon PE pt was extremely agitated with slurred speech. Pt started on anti-epileptic meds.  Facial twitching and leg jerking noted during admission as well as altered mental status and agitation. Pt having difficulty with sleep, only sleeping 3-4 hrs after medication.  Pt developed a rash with itching. Pt was in PICU until 11/13/07 then transfered to medical floor, the d/c on 11/16/07.				Y	Y	10			Y	10/22/2007	10/29/2007	7	EEG, CT + MRI of head. Labs and Diagnostics: CBC with platelet count 464. Chemistry with blood glucose of 228. UA with 3+ glucose. CT head WNL.  Brain MRI normal. CXR WNL.  EEG (+) for seizure activity.  Stool cx (-).  LP with normal cell count, protein, and glucose. CSF cultures and PCR all (-).	PVT	PVT	None	None	None. PMH:  none. NKDA.  Family hx of seizures.			1						1	Computerised tomogram; Convulsion; Electroencephalogram; Encephalopathy; Nuclear magnetic resonance imaging brain; Pyrexia	DTAP~SANOFI PASTEUR~C2657AA~5~UN~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2498AA~4~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A01692~4~UN~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0632R~2~UN~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1010U~2~UN~LA~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0297575	11/23/2007	NM	1.6	1	.6	F	11/05/2007	Adult Novartis influenza vacc. given to child < 4 yr.									U	10/12/2007			None	OTH	OTH		URI	None			1						1	Medication error; Wrong drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78994~3~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0297576	11/23/2007	WA	56.0	56		F	11/14/2007	Rash, itching, redness Initially arm was very sore and swollen and I was nauseous. Then in about 24 hrs I developed hives, which have cont'd. Arm is still red and a little sore. Hives are still present and very itchy and red.				Y					N	11/07/2007	11/08/2007	1		OTH	PVT	Prempro, Lexapro		None			1						1	Erythema; Nausea; Oedema peripheral; Pain in extremity; Pruritus; Rash; Urticaria	FLU3~CSL LIMITED~00149211A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0297577	11/23/2007	TX	53.0	53		F	11/16/2007	Within hours: 102 degrees fever; chills; headache; body aches lasted 3 days; very severe arm pain (a) injection site - entire arm warm hours				Y					Y	10/13/2007	10/15/2007	2	went to doctor; no lab tests administered	OTH	PVT	Synthroid .137; Atenolol .25	none	allergies to Prednisone, Decongestants, Ragweed, Mold, Mosquito			1						1	Chills; Headache; Injection site pain; Injection site warmth; Pain; Pain in extremity; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA063AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0297578	11/23/2007	MA	18.0	18		F	11/14/2007	Received Gardasil vaccine 10/10/07. Developed shoulder pain one week later that has persisted.									U	10/10/2007				PVT	PUB	Yaz	None	None			1						1	Musculoskeletal pain	FLU3~SANOFI PASTEUR~02437AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0960F~UNK~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~02367AA~UNK~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0297579	11/23/2007	CA	0.2	0	.2	M	11/14/2007	F/U shot given to 2 month old, no adverse effects									Y	10/27/2007			None	PVT	OTH		None	None			1						1	Inappropriate schedule of drug administration; Medication error; Wrong drug administered	FLU3~SANOFI PASTEUR~UT2456FA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297582	11/23/2007	UT	2.0	2	.5	F	11/15/2007	Pt received the Hepatitis A and Influenza vaccine on 11/1/07 and started getting swelling on the face 11/5/07, has given Benadryl. Was seen in office by Dr on 11/5/07 he has vaccination reaction from vaccines told pt to use Benadryl				Y					Y	11/01/2007	11/05/2007	4	None	PVT	PVT		None	None			1						1	Swelling face	FLU3~SANOFI PASTEUR~U2504AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB207~1~IM~LL~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0297583	11/23/2007	NC	56.0	56		F	11/11/2007	PATIENT NOTED RASH DEVELOPED ALTER IN THE DAY VACCINE RECEIVED									Y	10/31/2007	10/31/2007	0	None	OTH	PVT						1						1	Rash	FLU3~SANOFI PASTEUR~U2507AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297585	11/23/2007	PA	51.0	51		F	11/15/2007	Headache, rash 11-13-07; rash is fading 11/15.  Leg cramps 11-14-07; cramps continue.									N	11/12/2007	11/13/2007	1		PUB	PVT	Lipitor, Bactrim once a wk	None	Prevention for UTI, Bactrim once a week (took day of vac.)			1						1	Headache; Muscle spasms; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA029AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0297586	11/23/2007	VA	64.0	64		F	11/14/2007	Rash at injection site of flu vaccine-grouped vesicles and area of induration at site. -Rash/vesicles not seen anywhere else on body -appeared 3 days after injection-itchy initially but not now									Y	11/07/2007	11/11/2007	4	pending HSV/HZV culture sent of scraping of vesicle 11/14/07	PVT	PVT	Maxzide		HTN, subclinical hypothyroidism			1						1	Herpes simplex serology; Herpes zoster; Injection site induration; Injection site pruritus; Injection site rash	FLU3~SANOFI PASTEUR~02437AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0804U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297587	11/23/2007	OH	36.0	36		F	11/15/2007	Tenderness and muscle soreness entire (R) upper arm (shoulder to elbow). No redness or fever. States discomfort began 11/12/07 and continues to present.									U	11/12/2007	11/12/2007	0		PUB	PVT	Celebrex	None	Denies			1						1	Limb discomfort; Myalgia; Tenderness	FLU3~SANOFI PASTEUR~U2461AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297588	11/23/2007	CA	1.7	1	.7	M	11/11/2007	Hives; Paleness; Weak; Lethargic; Wouldn't eat or Drink; Spoke to Pediatrician put him on Benadryl Four Times a Day.									Y	11/02/2007	11/03/2007	1		PUB	PUB	Nexium 20MG; PEDCID 40MG	NONE	GERD			1						1	Asthenia; Diet refusal; Lethargy; Pallor; Urticaria	FLU3~SANOFI PASTEUR~UT2459KA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB175AA~2~UN~UN~HEP A (HAVRIX)~1	USA		Influenza
0297589	11/23/2007	RI	26.0	26		F	11/14/2007	PT. c/o lightheadedness 25 min after rec. injection (a) deltoid; BP 150/86 Pulse 88 no redness injection site. no sig, rash ; c/o feeling achey like I am getting the flu									Y	11/14/2007	11/14/2007	0	12:30 nurse Contacted pt - home resting Took Tylenol feels Tired but ok	UNK	UNK	Celexa; Trizodione;  BCP-lodosi	NONE	none Known			1						1	Dizziness; Fatigue; Pain	FLU3~SANOFI PASTEUR~U2451AA~3~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297591	11/23/2007	ID	13.0	13		M	11/15/2007	11-6-07 very red swollen size of golf ball very tender									Y	11/02/2007	11/06/2007	4		PVT	PUB		well				1						1	Erythema; Swelling; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80074~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C2771AA~1~IM~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1249U~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0297592	11/23/2007	ID	1.0	1	.0	F	11/15/2007	site red swollen 2.5 cm 3 cm				Y					Y	10/17/2007	10/29/2007	12		PVT	PUB		well				1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2458BA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0437U~3~IM~RL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0183U~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08700A~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1249U~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0297593	11/23/2007	ID	24.0	24		F	11/15/2007	red, hot area on (L) bicep area. cool arm tingling down arm. told to alternate heat and cold to site. watch for x/s of cellulitis or worsening s/s. Call if s/s get worse.									Y	11/13/2007	11/15/2007	2		PUB	UNK		None				1						1	Injection site erythema; Injection site warmth; Paraesthesia; Peripheral coldness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA310BA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0297594	11/23/2007	NY	2.0	2	.2	U		Seen 11/14/07 for fever that began about 8-9 pm. Fever in office 102.8. No URI symptoms. No local reaction to vaccine. On Bactrim for suspected UTI from 11/6/07. Left office had a febrile seizure. Sent to ER and had lumbar puncture, blood culture and labs.				Y					U	11/13/2007	11/13/2007	0	Lumbar puncture CBC, Chem profile, UA/UC Blood culture	PVT	PUB	Septra, Pulmicort, Fluoride, Vitamins	suspected UTI	RSV 2006, Asthma			1						1	Blood culture; Culture urine; Febrile convulsion; Full blood count; Laboratory test; Lumbar puncture; Urine analysis	FLU3~SANOFI PASTEUR~UT2474AA~3~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297598	11/23/2007	MI	66.0	66		M	11/13/2007	Myalgia, Nausea, headache, chills, diarrhea x 10 days.				Y					Y	10/19/2007	10/20/2007	1		PVT	OTH		None	CAD, HTN, DM, OSA, Depression, Prostate CA			1						1	Chills; Diarrhoea; Headache; Myalgia; Nausea; Sleep apnoea syndrome	FLU3~SANOFI PASTEUR~U249AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297601	11/23/2007	NY	48.0	48		F	11/19/2007	Nausea, vomiting, diarrhea, lethargy, fever, chills.  Out of work x7 days.				Y					U	11/08/2007	11/09/2007	1		UNK	UNK	Wellbutrin		Anemia, allergies-Dextran, Phenergan, Ceftin			1						1	Chills; Diarrhoea; Lethargy; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2507AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297602	11/23/2007	NY	4.0	4		M	11/16/2007	Mother called on 11/15/07 stating child had 9-10 chicken pox looking areas on stomach, shoulder, side and neck. Did not have a temperature. Inst. mom to call MD T.C. to mom 11/16/07 x 2 message left. T.L to mom 11/17/07-Areas scabbed over mom called MD -no visit made. Mom states child is fine today									Y	11/13/2007	11/15/2007	2	None	PUB	PUB	None	None				1						1	Rash vesicular; Scab	FLU3~SANOFI PASTEUR~U2461DA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB207BA~1~IM~LA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1341U~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0297603	11/23/2007	NE	23.0	23		F	11/20/2007	10 hours after receiving flu vaccine, noted a severe throat pain and noted tingling to (L) arm earlier in the evening. Awoke today with a red rash to the injected arm, spreading from deltoid to hand. The client reports the sore throat has persisted. Denies Respiratory distress. Sore throat continues this afternoon; redness to arm is gone.									Y	11/19/2007	11/19/2007	0	none	PUB	UNK	Birth Control Pill	none	none	past 4 yrs.~ ()~~0.00~In Patient		1						1	Erythema; Paraesthesia; Pharyngolaryngeal pain; Rash	FLU3~SANOFI PASTEUR~U2457HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297604	11/23/2007	MA	87.0	87		F	11/12/2007	Soon after flu vaccine, evolved swelling and pain of deltoid - pain radiates at times to hand persisted for 2 days - went to outpatient facility. Came to my office 4 days later; swelling lessened.				Y					Y	11/08/2007	11/09/2007	1		PVT	UNK		No	CVA - Diabetes - Hypertension - Lymphoma			1						1	Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2462AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297606	11/23/2007	LA	61.0	61		M	11/10/2007	From time vaccine administered, after two days, I began to run a high fever 104 degrees.  Had general flu like symptoms, ached all over.  After one day fever left but am still experiencing general fatigue & persistent cough.									U	11/03/2007	11/05/2007	2		OTH	PVT	Diovan 320 mg, Lasiks, 40 mg	None	High blood pressure			1						1	Cough; Fatigue; Influenza like illness; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~V0481~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0297609	11/23/2007	WA	76.0	76		M	11/14/2007	Joint and Muscle pain; BUMPS/RASH ON BODY, HANDS, LEGS; MOUTH SORES - FOR N 7 days post flu injection (No FEVER)									Y	10/31/2007	11/01/2007	1	None	PVT	PVT	NONE	NONE	NONE			1						1	Arthralgia; Myalgia; Rash generalised; Stomatitis	FLU3~SANOFI PASTEUR~U245299~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297610	11/23/2007	OH	93.0	93		F	11/15/2007	Sore arm 7 days after vaccination. treatment ibuprofen and ice									U	11/07/2007	11/08/2007	1		PUB	PVT		None				1						1	Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA319BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0297611	11/23/2007	WI	71.0	71		M	11/12/2007	About 09:00 AM had flu and pneumococcal vaccine administered. Both arms were stiff. About 1200 noon, pt started to get tremor in left arm that slowly worsened and spread through left torso section. Pt went to ER at about 1800 and was given Diazepam and Hydrocodone and the tremor subsided. Follow up call given on 11/14/07 and pt said has recovered.				Y					Y	11/09/2007	11/09/2007	0	N/A	OTH	UNK		N/A				1						1	Musculoskeletal stiffness; Tremor	FLU3~SANOFI PASTEUR~U2487AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1132U~1~IM~LL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0297613	11/23/2007	VA	33.0	33		F	11/06/2007	11/1 (2 days after injection): noticed hard and tender at site, (L) deltoid; progressed to axillary soreness and gradually developed numbness/tingling in arm and hand. 11/8: Throbbing pain. 11/3: pain persisted, skin hurt; tingling in arm and medial aspect (L) foot. To MD and was given Tylenol with codeine and Cephalexin. 11/6: Symptoms better, not gone, intermittent pain with tingling. Will return to MD if not resolved when medicine completed.				Y						10/30/2007	11/01/2007	2	None	UNK	UNK						1						1	Axillary pain; Hypoaesthesia; Injection site induration; Injection site pain; Pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79896~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0297614	11/23/2007	MT	18.0	18		F	11/09/2007	Pt states noted swelling, redness, soreness at injection site (R) arm morning after receiving shot - VZV vaccination - increasing to about 4 hard red area - rash (red) under side of arm - elbow up mid arm. No pox, warm to touch - lymph node enlarged inside (R) arm, still swollen to elbow Friday 11/9/07 - some tingling in (R) finger ? due to swelling at elbow.									Y	11/04/2007	11/05/2007	1	None	PUB	UNK		Sinus infection shortly after vaccination	Chronic sinus infection			1						1	Erythema; Injection site erythema; Injection site pain; Injection site swelling; Lymphadenopathy; Oedema peripheral; Paraesthesia; Rash; Skin warm	FLU3~SANOFI PASTEUR~U2488AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1341U~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0297615	11/23/2007	PA	69.0	69		F	11/12/2007	Redness around throat but no trouble breathing. No fainting. Notified primary MD already and followed up with pt at home: pt was instructed to use Benadryl OTC for few days per primary MD.										11/12/2007	11/12/2007	0		OTH	OTH						1						1	Pharyngeal erythema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA031AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0297616	11/23/2007	OH	64.0	64		M	11/13/2007	(L) upper arm - medial erythema with increased temp of skin or lymphangitis - not around the site of injection.									Y	11/12/2007	11/12/2007	0	None	PVT	PVT		None	NKDA, HTN, High chol, COPD			1						1	Erythema; Skin warm	FLU3~SANOFI PASTEUR~U2506AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0989U~2~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297617	11/23/2007	PA	56.0	56		F	11/12/2007	Rec'd vaccine on 10/17/07 at 10:45 am, at 6:50 PM that day (10/17/07) began with headache, body aches, joint pain, teeth pain, and nausea; injection site swollen (2 in diameter) and tender; felt feverish; felt the same on 10/18/07 and headache became migraine; migraine continued to 10/19/07 and resolved 10/19/07 PM.									Y	10/17/2007	10/17/2007	0	None	OTH	PVT		None	None	Mild fever~Influenza (Seasonal) (no brand name)~UN~0.00~In Patient		1						1	Arthralgia; Feeling hot; Headache; Injection site pain; Injection site swelling; Migraine; Nausea; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA064AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0297618	11/23/2007	OH	82.0	82		M	11/14/2007	Client states soreness noted in right deltoid in the evening. The following day, swelling was noted. Physician office visit on 11-8-07. Rx sulfamethoxazole b.i.d. By report date patients state soreness is gone and swelling is minimal.				Y					Y	11/06/2007	11/06/2007	0		PUB	PUB	Flomax; Metformin	None				1						1	Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2516AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0554U~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0297619	11/23/2007	OH	56.0	56		F	11/14/2007	Temp 102, chills, dry heaves, arm very sore w/in 2-3 hours, myalgia w/in 7 hours. 2nd and 3rd day fatigue only.									Y	11/10/2007	11/10/2007	0	Unknown	PUB	PUB	Spiriva, Nexium, Triamterene	Sick 3 wks prior - on antibiotic (Avelox)	Asthma, COPD	Same~Influenza (Seasonal) (no brand name)~UN~53.00~In Patient		1						1	Body temperature increased; Chills; Fatigue; Myalgia; Pain in extremity; Retching	FLU3~SANOFI PASTEUR~U2527AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297620	11/23/2007	OK	40.0	40		F	10/23/2007	(L) upper arm are of redness with induration and warmth 3.5 x 2.5 cm - no pain with palpation, area marked. Treated with Keflex 500mg. Dx: Cellulitis. F/up in 24 hours or sooner if s/s worsen.				Y					U	10/17/2007	10/18/2007	1	None	PVT	PVT	None	None	Breast Cancer			1						1	Cellulitis; Erythema; Induration; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70476~UNK~SC~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|MMR~MERCK & CO. INC.~0411U~2~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|TDAP~SANOFI PASTEUR~C2758AA~1~IM~UN~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1095U~UNK~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0297621	11/23/2007	VA	51.0	51		M	11/19/2007	See attachment; 11/07/2007, 2:00 p.m. - chills and fever temp 101, 2 tabs tylenlol 500mg every 6 hours; 11/08/2007 - chills and fever temp 101, muscle aches; 11/09/2007 - chills and fever 102, muscle ache and headache, alternating 2 tabs tylenol 500 mg and 2 tabs motrin 800 mg every 6 hours; 11/10/2007 - chills and fever temp 102, muscle ache, headache, hoarseness; 11/11/2007 - chills and fever temp 102, muscle ache, headache, hoarseness; 11/12/2007 - chills and fever temp 102, muscle ache, headache, hoarseness, and small and large hives appearing on hand, arms, and front, back, and sides of body. 11/13/2007, 5:00 a.m. - chills and fever temp 101, muscle ache, headache, hoarsenss; small and large hives connecting which made both arms and hands large and puffy with hives; face and eyes with large and puffy with hives. 8:00 a.m. went to hospital emergency room at Community Hospital. Given pain medication and benadryl through I.V.. Hives subsides. Diagnosed flu shot side effects,. 11/14/2007 to 11/17/2007 - sick in bed, stayed home, and continued to take medications prescribed by doctor, 2 tabs benadryl every 4 hours, 1 tab motrin 800 mg 3 times daily. 11/18/2007 - fully recovered. 11/19/2007 - back to work.				Y					Y	11/05/2007	11/07/2007	2	See attachment for blood culture results. 13 Nov 07 at 0950 (Coll) STAT WBC 6.3 TH/CUMM; RBC CNT 5.09 M/CUMM; HGB 16.3 G/DL; HCT 46.8 %; MCV 92.1 fL; MCH 32.0 PICOGRAMS; MCHC 34.8 G/DL; RDW 13.6 %; PLT CNT 124 L TH/CUMM; MPV 8.2 fL; NEU% 76.60 H %; LYM% 13.3 L %; MON% 7.9 %; EOS% 2.00 %; BAS% 0.20 %; NEU# 4.8 TH/CUMM; LYM# 0.8 L TH/CUMM; MON# 0.5 TH/CUMM; EOS# 0.1 TH/CUMM; BAS# 0.0 TH/CUMM; DIFF REVIEW; REFER TO MANUAL DIFF PERFORMED; SEGS/100 WBC 42 %; BANDS/100 WBC 28 H %; LYMPS/100 WBC 21.0 %; MONO/100 WBC 7.0 %; EOS/100 WBC 2 %; PLT EST SL. DECREASED; OTHER CELLS NORMAL-RBC; 13 Nov 07 at 0950 (Coll) Bacteriology Result; AEROBIC AND ANAEROBIC BLOOD CULTURES NEGATIVE AT 5 DAYS	MIL	MIL						1						1	Basophil count normal; Blood culture negative; Chills; Dysphonia; Eosinophil count normal; Haematocrit normal; Haemoglobin normal; Headache; Injection site reaction; Lymphocyte count decreased; Malaise; Mean cell haemoglobin concentration; Mean cell haemoglobin normal; Mean cell volume normal; Mean platelet volume decreased; Monocyte count decreased; Myalgia; Neutrophil count normal; Platelet count decreased; Pyrexia; Red blood cell count normal; Red cell distribution width normal; Swelling face; Urticaria; White blood cell count normal	FLU3~SANOFI PASTEUR~U2439AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297622	11/23/2007	FL	52.0	52		F	11/14/2007	Continued soreness in arm.  Limited mobility due to pain.  Dr.-warm compresses IB.				Y					U	10/01/2007	10/01/2007	0		UNK	UNK		None	Rosacea			1						1	Mobility decreased; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78479~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0297623	11/23/2007	WI	14.0	14		F	11/15/2007	Within 15 min., had nausea and dizziness - 10 min later had shortness of breath and heaviness in chest - went to ER - had nebulizer tx - s/s resolved - the next am had renewed s/s - went to ER for 2nd Neb Tx- Recovered.				Y					Y	11/12/2007	11/12/2007	0	CBC, Chest X-ray within normal limits	PUB	PUB	Pepcid as needed	None	AML - Remission - 2 Bone Marrow Transplant			1						1	Chest X-ray normal; Chest discomfort; Dizziness; Dyspnoea; Full blood count normal; Nausea	FLU3~SANOFI PASTEUR~U2438AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297624	11/23/2007	CO	62.0	62		M	11/15/2007	She has had persistent pain at site of injection. Significant enough that she's not been able to sleep normally due to pain. No signs of infection or inflammation.									U	10/27/2007	10/27/2007	0	None	OTH	PVT	None	None	None			1						1	Injection site pain; Insomnia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA305BA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0297626	11/23/2007	CA	1.26	1	.3	M	11/15/2007	3cm Bilat Swelling thighs, no fever, mild pain able to walk and run									U	11/13/2007	11/14/2007	1	none	OTH	OTH	none	none	none			1						1	Injection site pain; Injection site swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~016AA~UNK~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT24591B~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~21AA~UNK~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~143B~UNK~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0297627	11/23/2007	NY	14.0	14		F	11/21/2007	APPROXIMATELY 2 DAYS AFTER VACCINE ADMINISTRATION PATIENT DEVELOPED A RASH ON ENTIRE BODY DESCRIBED BY MD AS VIRAL EXANTHUM,				Y					U	11/06/2007	11/08/2007	2	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Rash generalised; Viral rash	FLU3~SANOFI PASTEUR~U2523AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297628	11/23/2007	OH	71.0	71		M	11/05/2007	States got flu shot 10/31/07 - States he showered but did not remove bandaid until next morning - then noticed red itchy bumpy area. States area around shot was also swollen. The red bumpy area on 11/05/07 was in area of padded part of bandaid - States he has latex allergy but bandaids weren't latex ones. 11-7-07 called him - States it is better he did stop by Dr's office on 11-5-07									Y	10/31/2007	11/01/2007	1	( none were done	PUB	PUB	Neurontin 300mg 2/Day; Mycolme 250mg 3/day; metatal 100mg 2/day	denies any	Seizures; Latex allergy - milk; ice cream			1						1	Injection site erythema; Injection site pruritus; Injection site rash; Injection site swelling	FLU3~SANOFI PASTEUR~U2527AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297629	11/23/2007	OH	65.0	65		F	10/26/2007	Flu shot on Wed afternoon - Arm little sore am of next day. But worse as days went on. Kept her up during the night. Took Tylenol about 7pm (Thurs) states can't raise arm. Took more Tylenol at 11pm. Elevated in chair with ice pack 2 more Tylenol At 2am and more at 530 am. Had to have husband help her dress. Spoke to her on 11/16/07. States that it went away the next day and she is ok. She did not contact Dr. (family).									Y	10/24/2007	10/25/2007	1	None.	PUB	UNK	Celebrex; Metformin; Tramadol		Fibromyalgia; Diabetes			1						1	Activities of daily living impaired; Injected limb mobility decreased; Pain in extremity; Sleep disorder	FLU3~SANOFI PASTEUR~U2465AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297632	11/23/2007	CA	47.0	47		F	11/14/2007	Dizziness, Nausea, Difficulty Breathing Pt. was prescribed Ativan at the emergency room.				Y					Y	11/12/2007	11/13/2007	1		PVT	PVT		NONE	NKDA, DM, HTN			1						1	Dizziness; Dyspnoea; Nausea	FLU3~SANOFI PASTEUR~U2497AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0993U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0297633	11/23/2007	CA	65.0			F	11/21/2007	Had redness and swelling at injection site (Lt deltoid) immediately after injection was given.  Also has slight dizziness.  B/P-140/90, pulse 64.  Re-checked patient at 9:30AM B/P-144/92, pulse-66.  There was less redness and swelling at injection site.  Patient feeling good except for slight dizziness.  Checked again at 11:00AM B/P-138/88, pulse 72.  Feeling good.  No pain or redness at injection site.  Still very slight dizziness.  Instructed to see MD if dizziness continues or has any other symptoms.									Y	11/20/2007	11/20/2007	0	None	PUB	PUB		Diabetes, hypertension				1						1	Blood pressure; Dizziness; Heart rate normal; Immediate post-injection reaction; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U25099AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297634	11/23/2007	MN	0.9	0	.9	F	11/21/2007	2nd dose of influenza admin. 4 days early.  Appt not listed as 2nd dose.  Parent never stated this was 2nd dose.									Y	10/24/2007				OTH	OTH	None	None	None			1						1	Inappropriate schedule of drug administration; Medication error	FLU3~SANOFI PASTEUR~UT2473GA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297636	11/23/2007	TX	51.0	51		M	11/08/2007	Within 15 minutes of receiving injection, felt chest tightness.  (Did not return to clinic.)  Lasted a few minutes.  In evening felt feverish, aching & had chills until fever broke in the night.  R underarm lymph nodes swollen & tender, lasted 48-60 hours.  No treatment sought.									Y	11/01/2007	11/01/2007	0	None	OTH	PVT	Pulmocort, Albuterol PRN	None	Seasonal allergies; asthma			1						1	Chest discomfort; Chills; Lymph node pain; Lymphadenopathy; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2466AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1226U~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297637	11/23/2007	TX	56.0	56		F	11/08/2007	Fever, aches, joint pain developed within 9 hours.  Fever broke during the night.  R underarm lymph nodes swollen (palpable) & tender 3 days.  36 hours after vaccine noted 2 reddened circular area near armpit.  All symptoms resolved 4 days post injection.  No treatment sought.									Y	11/01/2007	11/01/2007	0	None	OTH	PVT	OTC antihistamines	No	Nasal allergies, frequent URI's			1						1	Arthralgia; Erythema; Lymph node pain; Lymphadenopathy; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2466AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1226U~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297638	11/23/2007	TX	54.0	54		F	11/08/2007	Noted black coloration (like dirt or oil) of knuckles & fingernails of both hands, could not be washed off.  Felt tight chest, anxious in afternoon & evening.  Black coloration lasted 48 hours, no treatment sought.  On 11/7/07, 5 days post vaccine administration, patient reports feeling worse than ever - sore throat, joint pain (especially neck & shoulders).  Taking ibuprofen regularly.  On 11/8/07, 6 days post vaccine, patient reports symptoms no better; aching all over; shoulders & neck very painful.  Fever last night 100 degrees.  Encouraged to see Dr. - will do so on 11/9/07 if not feeling better.									U	11/01/2007	11/01/2007	0	None as of this date.	OTH	PVT	BP med., Lipitor, Premarin, Synthroid	None	Transposition of great vessels - heart block 26 yr. ago (has pacemaker).			1						1	Anxiety; Arthralgia; Chest discomfort; Nail discolouration; Pain; Pharyngolaryngeal pain; Pyrexia; Skin discolouration	FLU3~SANOFI PASTEUR~U2466AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1226U~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297642	11/23/2007	GU	76.0	76		F	11/19/2007	On Oct. 17, 2007 patient requested to be given flu shot with other staff of the dental clinic.  I accommodated all of them (5 staff and gave flu shots).  After about 4 days patient came to the clinic and showed me her arms with bluish discoloration.  Advice given to go to her PMD.  She informed me that she is on Coumadin for 1 yr. already.				Y					Y	10/17/2007	10/18/2007	1		PUB	UNK	Coumadin					1						1	Anticoagulant therapy; Skin discolouration	FLU3~SANOFI PASTEUR~U2490AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297643	11/23/2007	NM	3.0	3		M	11/21/2007	Per mom, bedwetting, decreased appetite, mumbling, speech deficit, increased temper tantrums.									U	11/14/2007	11/15/2007	1	Normal exam, pt alert & playful	PUB	OTH	None	None	None			1						1	Aggression; Decreased appetite; Enuresis; Speech disorder	FLU3~SANOFI PASTEUR~U2457EA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297644	11/23/2007	TX	36.0	36		M	11/08/2007	Reported pain & decreased mobility the evening of the injection.  By the next morning a raised red line developed from the injection site into the left armpit.  The line was very tender.  All symptoms gone by 4th day post injection.  No treatment sought.									Y	10/25/2007	10/25/2007	0	None	OTH	PVT	OTC allergy meds	None	Nasal allergies, frequent URI's, pneumonia x2 in 2006			1						1	Injection site erythema; Injection site pain; Injection site streaking; Mobility decreased; Pain	FLU3~SANOFI PASTEUR~U2466AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1226U~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297645	11/23/2007	WA	12.0	12		F	11/23/2007	Nausea, dizziness & vomiting during 12-24 hours after vaccines.									Y	11/08/2007	11/08/2007	0	None	PVT	PUB	None		h/o migraines, allergic rhinitis			1						1	Dizziness; Nausea; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80959~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HPV4~MERCK & CO. INC.~0388U~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2375BA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B015BA~1~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0297646	11/23/2007	TX	40.0	40		F	11/20/2007	Pain and numbness in arm.  Began when shot was given and is continuing.  Has difficulty lifting arm and tingling esp. at night.									U	10/30/2007	10/30/2007	0		OTH	PVT						1						1	Hypoaesthesia; Mobility decreased; Pain in extremity; Paraesthesia	FLU3~SANOFI PASTEUR~U2510AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297647	11/23/2007	MD	52.0	52		F	10/31/2007	Left sided weakness.									N	10/18/2007	10/19/2007	1	At private physician's office.	OTH	PVT	Synthroid	None	No thyroid, cancer of thyroid-takes Synthroid	None~ ()~~0.00~In Patient		1						1	Hemiparesis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78994~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0297648	11/23/2007	PA	40.0	40		F	11/23/2007	swelling, redness, itching and mild edema induration at site. large. Benadryl po; Ice				Y					Y	11/19/2007	11/19/2007	0		OTH	PVT	Humibid		generalized allergies trees, grass, pollen, dust, dander			1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site pruritus; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA052AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0297684	11/23/2007	OH	67.0	67		M	11/23/2007	Received shot on Thrusday 15 Nov 2007. Sick to the stomach, nausua, and continuous headache to date.				Y					N	11/15/2007	11/15/2007	0		MIL	MIL		None				1						1	Headache; Malaise; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0297685	11/23/2007	NY	8.0	8		F	11/23/2007	None. Vaccine not approved for age group.									Y	11/02/2007	11/19/2007	17	None	PVT	PVT	Singular, Albuteral	None	Allergy to Zithromax			1						1	Inappropriate schedule of drug administration; Medication error; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~A317AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0297686	11/23/2007	NY	16.0	16		F	11/23/2007	None. Vaccine not approved for age group.									Y	11/05/2007	11/19/2007	14	None	PVT	PVT	None	None	PCN			1						1	Inappropriate schedule of drug administration; Medication error; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU280DA~4~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0297687	11/23/2007	NY	14.0	14		F	11/23/2007	None. Vaccine not approved for age group.									Y	11/02/2007	11/19/2007	17		PVT	PUB	None	None	None			1						1	Inappropriate schedule of drug administration; Medication error; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~A517AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0297688	11/23/2007	NY	13.0	13		F	11/23/2007	None. Vaccine not approved for age group.									Y	11/12/2007	11/19/2007	7	None	PVT	PVT	None	None	None			1						1	Inappropriate schedule of drug administration; Medication error; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~A317AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0297689	11/23/2007	NY	4.0	4		M	11/23/2007	None. Vaccine not approved for age group.									Y	10/25/2007	11/19/2007	25		PVT	PVT	None	None	None			1						1	Inappropriate schedule of drug administration; Medication error; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~A280DA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0297691	11/23/2007	KS	1.25	1	.3	M	11/23/2007	The patient had a fever and apparent febrile seizure within 24 hours of having immunizations.				Y					Y	11/15/2007	11/15/2007	0	CBC and BMP obtained at ER visit.	PVT	PVT	Tylenol	Had recently had a viral upper respiratory tract infection, but was recovered from this.	Otherwise healthy with no allergies.			1						1	Febrile convulsion; Full blood count; Laboratory test	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B061BB~UNK~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2456AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1437F~UNK~IM~LL~HIB (PEDVAXHIB)~1	USA	Emergency room visit	Influenza
0297692	11/23/2007	IA	59.0	59		F	11/23/2007	SWOLLEN, PAINFUL ARM, RED STREAKS ON ARM - OCCURED DAY AFTER VACCINE WAS ADMINISTERED. PATIENT WENT TO ER, ER DOC GAVE SHOT OF ANTIBIOTIC (PER PATIENT)AND SENT HER WITH A PRESCRIPTION FOR CEPHALEXIN 500MG FOUR TIMES DAILY AND INSTRUCTIONS TO FOLLOW UP WITH HER FAMILY PHYSICIAN.  PATIENT HAS AN APPOINTMENT WITH FAMILY DOC MONDAY (5 DAYS AFTER EVENT).				Y					U	11/21/2007	11/22/2007	1		UNK	UNK	PREMARIN 0.3MG, TRAMADOL 50MG, LUNESTA 3MG, SIMVASTATIN 10MG, HYDROCHLOROTHIAZIDE 25MG,  SINGULAIR 10MG, DILTIAZEM ER 240MG, LISINOPRIL 40MG, AMITRIPTYLINE 50MG, SERTRALINE 50MG	NONE				1						1	Erythema; Oedema peripheral; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA051AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1347U~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0297693	11/23/2007	CO	4.0	4		M	11/23/2007	Patient returned to clinic approximately 30 minutes after vaccines given due to chest pain, watery eyes, difficulty breathing that started about 10min after vaccines administered.  Very mild redness at site of varivax.  Patient was noted to be wheezing and was given an albuterol neb, prednisone and benadryl which seemed to relieve symptoms.				Y					Y	11/20/2007	11/20/2007	0	Chest x-ray normal	PVT	PVT	None	None	None			1						1	Chest X-ray normal; Chest pain; Dyspnoea; Injection site erythema; Lacrimation increased; Wheezing	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B049AA~6~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2454AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0548~5~SC~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0827R~3~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1509F~3~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0297694	11/23/2007	IA	91.0	91		F	11/23/2007	Mom lost hearing in both ears after receiving the flu short.  Her right ear has gradually regained hearing, but the hearing loss comes and goes.  Her left ear has shown some improvement, but limited.  Even though when she can, she isn't always able to comprehend what is being said.  She normally doesn't have a problem with hearing loss or understanding conversation.									N	10/10/2007	10/17/2007	7	Mom will be seeing a ear, nose, & throat doctor this week, following my recommendation.  Sonogram and monitor for heart, thinking it was a heart condition.	UNK	UNK	Metoprol, Vytorin, baby aspirin	None	Allergies to mold.  No birth defects.  Has a problem with hypertension and cholesterol	None~ ()~NULL~~In Patient|None~ ()~NULL~~In Sibling1|None~ ()~NULL~~In Sibling2		1						1	Deafness bilateral; Ear, nose and throat examination; Echocardiogram; Ultrasound scan	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0297696	11/24/2007	FL	57.0	57		F	11/24/2007	Shot was administered very high on the arm, practically in the shoulder socket or ligament.  Shot was extremely painful when administered.  I still have considerable pain in the shoulder/muscles, radiating down my back.  Movement is affected in that shoulder.  The pain comes and goes during the day, but is severe enough to wake me several times in the middle of the night.  I have continued to excercise and stretch the affected muscles but it is painful to do that.  I mentioned it to my doctor approx 2 weeks after the shot, who told me to continue to monitor it and continue stretching.  I really can't afford to go to an orthopedist at this time.									N	10/22/2007	10/22/2007	0	None so far, but I do plan to go when I can afford to.	UNK	UNK	Cozaar	None	Sulfa	NONE~ ()~~0.00~Patient		1						1	Injected limb mobility decreased; Pain	FLU3~SANOFI PASTEUR~U2507AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297697	11/24/2007	UT	31.0	31		F	11/24/2007	For several months I was going to the Doctor for cronic pain, numbness in my arms and constant nausea and dizziness.  Doctors tried to diagnose me with MS, Fibromyalgia and Cronic Fatige after months of blood tests and other testing.  None of these illness' fit my problems exactly and were all ruled out.  The illness began to spread into my nerves and I felt like I was having seizures, could not sleep at all - even with large dose sleeping pills and did not feel like myself.  After months of testing and nothing to help, I felt like I was dying a slow death.  The symptoms started to spread through my entire body.  At first only one side of my body was numb and had pains, it then spread to the other side.  I now have pains in every joint in my body.  I feel like I am 80 years old suffering from RA.  When I was very sick, I felt like I was being slowly poisioned.  I had the flu shot in October of 2006.  I was finally directed to a Doctor in the beginning of April who I feel saved my life.  He told me I had a form of Syrum sickness from the flu shot and immediately had me take Prednisone.  It took eight weeks of being on Prednisone before I began to feel like myself again.  The mini seizures have stopped now.  I have taken Prednisone for eight months now just to treat the symptoms and function in daily life.  I was not able to perform nomal tasks without this medication.  I am slowly weaning from the medication by reducing dosage 1mg a month.  I have been told to expect at least two years before symptoms to reduce.  At this point, I do not know what the long term permanent damage will be.  My 5 yr old son who also received a flue shot on the same day as me is also suffering similar aches and pains and problems that I encountered.  I have not felt his symptoms have been bad enough to justify the dangers of taking prednisone.  I hope more than anything his problems will correct themselves on their own.  I cannot stress enough that this has been the most miserable experience of my life.  I may never be the same again (or my son) just because I thought I was doing the right thing getting a Flu shot.  Please advise people on the dangers.  It is very real.				Y					N	10/21/2006	11/15/2006	25	Brain MRI, every blood test possible, full body CT scan, colonoscopy, and spinal tap.	UNK	UNK		none	Hypothryoidism			1						1	Arthralgia; Blood test; Colonoscopy; Computerised tomogram; Convulsion; Dizziness; Fatigue; Fibromyalgia; Hypoaesthesia; Insomnia; Lumbar puncture; Multiple sclerosis; Nausea; Nuclear magnetic resonance imaging brain; Pain; Serum sickness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0297699	11/24/2007	CO	68.0	68		F	11/24/2007	As the nurse was administering the flu shot, the needle separated from the syringe and the entire contents of the vaccine shot into the patient's left eye. No eye wash solution was provided. A second shot was administered to patient, but was not recorded in patient's chart.Patient reported a gritty feeling under her eyelid immediately after the incident and for several days following. She also reported watery eyes and sharp pains behind both eyes a few days later.									U	11/06/2007	11/06/2007	0		PVT	UNK						1						1	Drug administration error; Eye pain; Lacrimation increased; Medical device complication	FLU3~SANOFI PASTEUR~U2498AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297700	11/25/2007	IN	1.5	1	.6	M	11/25/2007	Vaccines at 4:30 pm, given tylenol at 4:45.  Awoke with chills at 9:50, gave ibuprofen, but fever immediately rose-last measured at 103.3 but still rose higher within approx. 5-10 minutes.  Then breathing was labored & he had a grand mal seizure, lost consciousness and stopped breathing.  Per 911, put on left side & undressed, & he regained consciousness & breathing.  Ambulance arrived at 10:02-gave O2, checked blood sugar & vitals, took to ER.  ER Dr. gave more ibuprofen & tylenol & told us to alternate doses & increase dose we were normally giving.  Next day at Peds office, checked vitals & reflexes- felt certain seizure brought on by fever caused by vaccinations.				Y					Y	10/30/2007	10/30/2007	0		PVT	PVT	tylenol after vaccinations at 4:45 pm	none	none			1						1	Apnoea; Chills; Dyspnoea; Grand mal convulsion; Loss of consciousness; Pyrexia; Respiratory arrest	DTAP~UNKNOWN MANUFACTURER~unknown~4~IM~LL~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~unknown~3~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~unknown~3~IM~RL~HEP A (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0296518	11/26/2007	IL	67.0	67		F	11/19/2007	Rash on both arms, trunk of body and top of both legs. Started as blotches that spread. Resembled a severe sunburn. 2 steroid shots and Prednisone dose pack, which gave no relief. Cardazone cream and Varicream. Took 6 weeks to completely clear up. Body still very dry.									Y	10/10/2007	10/15/2007	5	Had punch biopsy.	PUB	UNK		None	None			1						2	Rash; Biopsy; Biopsy skin; Dry skin; Rash; Rash macular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80432~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0296856	11/26/2007	MN	33.0	33		F	11/19/2007	Seriousness Criteria: Other-Medically Significant Initial report received from a health professional on 08 November 2007. A 33-year-old female with history of allergies to codeine, Dilaudid, milk and cats received a fourth dose of Fluzone (lot number U2487AA) administered intramuscularly to the right deltoid) on 06 November 2007 and within minutes complained of redness and itching at the injection site. She then complained of her throat feeling thick, and she developed shortness of breath. She was taken in the emergency room and received treatment with 0.3 mg epinephrine times three and 125 mg intramuscular Solu-Medrol. All symptoms resolved and the patient was released from the emergency room.				Y					Y	11/06/2007	11/06/2007	0		UNK	UNK			The patient had a history of allergies to codeine, Dilaudid, milk and cats. The reporter was unsure if the patient had any other significant medical history, unsure if the patient was taking concomitant medications and unsure if the patient received any other vaccinations within four weeks prior to 06 November 2007. The patient did not have any illness at the time of vaccination and did not receive any other vaccines on 06 November 2007. It was not known if the patient experienced adverse events following prior vaccinations.		200703820	1						2	Dyspnoea; Injection site pruritus; Dyspnoea; Injection site erythema; Injection site pruritus; Pharyngeal oedema	FLU3~SANOFI PASTEUR~U2487AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2487AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0296965	11/26/2007	IN	27.0	27		F	11/19/2007	Initial report received from a health care provider on 08 November 2007. A 27-year-old female patient with a medical history of seizures, had received an intramuscular left deltoid injection of Fluzone SV 2007-2008, lot number U2464AA on 24 October 2007 and 30 minutes later, she experienced generalized itching, couldn't catch her breath and had fainted. The patient was in and out of consciousness and medics were called. IV fluids, oxygen and Benadryl were administered. The patients vitals; BP 215/120, HR 127, with irregular breathing. The patient was taken to the emergency room (ER). She began having a migraine and the left side of her body became numb. Relevant diagnostic testing performed included CT Scan, EKG, and a heart monitor (results not provided). The patient was monitored in the ER, discharged with a diagnosis of viral infection and prescribed antibiotics. The patient followed-up visit with her physician the next day. The patient had recovered from the event.				Y					Y	10/24/2007	10/24/2007	0	CT Scan, EKG, Heart Monitor - results not provided.	PUB	PUB			The patient had a history of seizures and had not been ill at the time of vaccination. It was unknown if the patient had been taking any concomitant medications.		200703817	1						2	Dehydration; Dyspnoea; Feeling abnormal; Heart rate increased; Hypertension; Loss of consciousness; Migraine; Pruritus; Sinusitis; Syncope; Altered state of consciousness; Computerised tomogram; Dyspnoea; Electrocardiogram; Hypoaesthesia; Loss of consciousness; Migraine; Pruritus generalised; Syncope; Viral infection	FLU3~SANOFI PASTEUR~V02464AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2464A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0297704	11/26/2007	WA	62.0	62		M	11/26/2007	Tendinitis like symptoms in vaccinated arm in elbow.  I am alergic to thimerisol and the vaccine contained thimerisol.									U	11/06/2007	11/07/2007	1		UNK	UNK						1						1	Tendonitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0297705	11/26/2007	NY	59.0			M	11/26/2007	Recieved flu shot 11/21/07. Within 2 days had flu symptons, and within 3 days had the flu fairly bad! As of 11/26 I'm still quiet sick.														UNK	PVT						1						1	Influenza	FLUX~UNKNOWN MANUFACTURER~aflua3188a~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0297706	11/26/2007	IL	71.0	70		F	11/26/2007	Raised red areas around waist and mild itching									Y	10/22/2007	10/23/2007	1	N/A	UNK	UNK	Unknown	Unknown	Unknown			1						1	Pruritus; Rash erythematous	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~784811~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0297707	11/26/2007	IL	66.0	13		F	11/26/2007	Left arm/Left shoulder pain, red, swollen warm, to the touch.  Upset stomach									Y	10/18/2007	10/18/2007	0	N/A	UNK	UNK	Unknown	Unknown				1						1	Erythema; Musculoskeletal pain; Pain in extremity; Skin warm; Stomach discomfort; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78481~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0989U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297708	11/26/2007	IL	28.0	10		F	11/26/2007	Painful, swollen red bumps on Left arm.Ran temp of 103.  Shoulder and  left arm sore.  Went to MD on 10/19 received antibiotics and advised by physician not to get pneumonia shots.									Y	10/16/2007	10/16/2007	0	Unknown	UNK	UNK	Unknown	Unknown	Unknown			1						1	Body temperature increased; Musculoskeletal pain; Pain; Pain in extremity; Rash erythematous; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78481~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0989U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297709	11/26/2007	MI	66.0	66		F	11/26/2007	Patient reports itching that sent her to ER on 10/27/2007. She reports that they treated her for an allergic reaction, giving her an IV and a script for an oral medication. Later went to her primary medical provider who gave diagnoses of Shingles. Patient states that the rash started as pimples on skin, beginning on her neck and later spreading to her hips. Medical provider also began testing for other symptoms:based on a recent kidney scan, patient has just been diagnosed with cancer in right kidney. Further medical appointments now scheduled for patient. Patient relates following symptoms due to Shingles: open sores on buttocks, pain, and diarrhea. Treatment consists of Benedryl, soda baths and a white pill. Patient also stated that she now had chicken pox on neck and buttocks. A call was placed to her health care provider to confirm chickenpox (a reportable disease). Provider confirmed Shingles but denied that patient had chickenpox. Provider states that patient does now have diagnoses of cancer but that she did not have that diagnoses at time of vaccination.				Y					N	10/25/2007	10/27/2007	2		PUB	PUB		None	Allergic to seafood, soy, mercurochrome			1						1	Diarrhoea; Herpes zoster; Hypersensitivity; Pain; Pruritus; Rash vesicular; Renal cell carcinoma stage unspecified	FLU3~SANOFI PASTEUR~U2523AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~0743U~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0297710	11/26/2007	IL	72.0	0	.3	M	11/26/2007	Left arm Red, swollen, warm  to the touch, unable to lay on it.									Y	10/16/2007	10/16/2007	0	Unknown	UNK	UNK	Unknown	Unknown	Unknown			1						1	Erythema; Oedema peripheral; Pain in extremity; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78481~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0989U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297713	11/26/2007	IL	71.0	69		F	11/26/2007	Redness, pain and swelling to Right arm...swelling approx. 20cm x 20cm per physician office...									Y	10/11/2007	10/11/2007	0	Unknown	UNK	UNK	Unknown	Unknown	Unknown			1						1	Erythema; Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78481~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0554U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297714	11/26/2007	IL	71.0	71		M	11/26/2007	Left arm Red, painful, lethargic, couldn't sleep, arm too sore.									Y	10/03/2007	10/03/2007	0	Unknown	UNK	UNK	Unknown	Unknown	Unknown			1						1	Erythema; Insomnia; Lethargy; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78481~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0544U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297715	11/26/2007	IL	71.0	0	.0	F	11/26/2007	Right arm red, painful									Y	10/03/2007	10/03/2007	0	Unknown	UNK	UNK	Unknown	Unknown	Unknown			1						1	Erythema; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78421~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0554U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297717	11/26/2007	IL	77.0	77		F	11/26/2007	Upper Left Arm red, swollen, warm to touch, just lower part of arm not at injection site.									Y	10/05/2007	10/05/2007	0	Unknown	UNK	UNK	Unknown	Unknown	Unknown			1						1	Erythema; Oedema peripheral; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78476~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0964U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297718	11/26/2007	IL	65.0	65		F	11/26/2007	Knot under arm..Pain when press on lump under arm.									Y	10/04/2007	10/04/2007	0	Unknown	UNK	UNK	Unknown	Unknown	Unknown			1						1	Nodule; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78481~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0006473900~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297719	11/26/2007	IL	70.0	70		F	11/26/2007	Swelling in the left arm. Redness, tender and painful									U	09/28/2007	09/28/2007	0	Unknown	MIL	UNK	Unknown	Unknown	Unknown			1						1	Erythema; Oedema peripheral; Pain in extremity; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA300AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~05544~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297720	11/26/2007	NY	12.0	12		F	11/26/2007	11/16/2007  7:30 am patient had episode of spinning-head tilted to r-then whole body shaking lasting less than 2 minutes- no fever- EMS called and taken to ER- ?partial complex seizure vs syncopal episode.  Transferred to Hospital for further evaluation. Discharged home on 11/18/2007.  On 11/20/2007 mom called to say that patient had another seizure.  She returned to hospital and was begun on depakote. 1/2/08-records received for DOS 11/16-11/18/07-DC DX: Seizure. One episode of eye twitching. Per parent happened 3 times, collapssed. No post ictal state. 1/2/08-records received for DOS 11/16-11/18/07-DC DX seizure.  Morning of ER visit found on floor.  Per 60 day follow up: Patient diagnosed with generalized epilepsy by neurologists. MRI brain- normal. She is being treated with DEPAKOTE ER 500 mg qhs. R/C in EEG consistent iwth genralized motor epilepsy.				Y	Y	2			U	11/12/2007	11/16/2007	4	CT scan head - normal, EKG-normal, screening blood test (CBC, electrolytes) -normal, Video EEG- results pending, MRI- results pending 1/2/08-records received-EKG normal sinus rhythm. CT ventricles normal. VEEG generalized seizures during sleep.	UNK	UNK	singulair 5mg qd, advair 100/50 1 puff bid		asthma 1/2/08-records received-PMH:asthma.			1						1	Blood electrolytes normal; Computerised tomogram normal; Electrocardiogram normal; Epilepsy; Full blood count normal; Nuclear magnetic resonance imaging; Posture abnormal; Syncope; Tremor; Vertigo; Blood electrolytes normal; Complex partial seizures; Computerised tomogram normal; Convulsion; Electrocardiogram normal; Electroencephalogram; Full blood count normal; Nuclear magnetic resonance imaging; Posture abnormal; Syncope; Tremor; Vertigo	FLU3~SANOFI PASTEUR~U2524AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~12676~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2538AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2862AA~1~IM~LA~TDAP (ADACEL)~1|FLU3~SANOFI PASTEUR~U2524AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|HPV4~MERCK & CO. INC.~12676~1~IM~RA~HPV (GARDASIL)~2|MNQ~SANOFI PASTEUR~U2538A~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TDAP~SANOFI PASTEUR~C2862A~1~IM~LA~TDAP (ADACEL)~2	USA	Hospitalisation	Influenza
0297721	11/26/2007	VT		53		F	11/26/2007	Vaccine administered about 1 pm. Hives started in the afternoon/, fever, chills, muscle aches. Chest fill up almost like an asthma attack, chest congestion, coughing with heart racing lasting about 6 hours. Also developed headache, states gets migraines.									Y	11/15/2007	11/15/2007	0		PVT	PVT						1						1	Chest discomfort; Chills; Cough; Headache; Myalgia; Palpitations; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U2479AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297722	11/26/2007	MD	82.0	82		F	11/26/2007	Received Flu vaccine on Oct 16th at public clinic. Given in right upper deltoid.  That evening complained of right arm discomfort and ache.  Pain radiated to right breast and then to the right side of neck but this has subsided. The pain in sporadic and occurs between the right shoulder and elbow.  Using Buster-R cream to help pain.									U	10/16/2007	10/16/2007	0	Has not gone to the physician - refuses to go even though urged to go.	PUB	PVT	Lanoxin, Toprol, Cozaar, Norvasc, Neurontin, Prandin	Diabetes, Peripheral neuropathy in lower extremities, Hypertension, irregular heartbeat requires pacemaker,	See box 18, additionally had past mini cva, breast cancer (lt mastectomy)			1						1	Breast pain; Neck pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78479~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0297723	11/26/2007	NE	7.0	7		F	11/26/2007	Mother called clinic day after (11-17) vaccines were given to repot a 2 inch bump underneath the arm the vaccines were given. No fever at that time. Patient was scheduled to be seen in the office that day.  Evaluated by a provider and area of approx. 3cm in diameter of redness and swelling that was warm to touch noted.  Area is posterior area of R) arm.  Parent instructed to apply cool pack and observe.  Mother called back the next day (11-18) and patient is seen again by provider.  Redness has spread outside the area of a line drawn the day before.  Overall however there is less intense redness and the hardness int he middle and swelling seems improved.  No drainage or skin breakdown noted.  Area is more warm and tender than is was yesterday.  Patient was started on Amoxil the day of the immunizations due to an ear infection. Amoxil is stopped and patient is started on Augmentin.				Y					Y	11/16/2007	11/17/2007	1	None	PVT	PVT	Albuterol, Amoxicillin	Ear infection	None			1						1	Erythema; Induration; Nodule; Oedema peripheral; Skin warm; Tenderness	FLU3~SANOFI PASTEUR~U2528AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1355U~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0297727	11/26/2007	TX	52.0	52		F	11/26/2007	Vaccine was given to me in left arm Friday afternoon, Nov. 23. I Immediately felt itching at injection site which went away after about 10 minutes.  Later in evening and next two days, I had stomach upset (diarrhea).  Also, the next morning, I awakened with a headache and developed pain in back and muscles all over body as well as low grade fever in the evening (with chills). Fever and chills gone after one day, but even today (3rd day), I still don't feel completely well.									U	11/23/2007	11/23/2007	0		UNK	PVT	Mirapex, Topamax, Inderal LA, Vytorin, Zoloft, Wellbutrin	None	Migraine, Restless Legs Syndrome, Elevated Cholesterol, Depression			1						1	Back pain; Chills; Diarrhoea; Headache; Immediate post-injection reaction; Injection site pruritus; Malaise; Myalgia; Pyrexia; Stomach discomfort	FLU3~CSL LIMITED~Not Known~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0297728	11/26/2007	IA	40.0	40		F	11/26/2007	Sudden onset of cough, general achiness, red eyeswith scratchiness and painful throbbing sensation. red eyes lasted 2 days/headache for one day				Y					Y	11/05/2007	11/05/2007	0	none	PUB	PUB	none	no	none			1						1	Cough; Eye pain; Eye pruritus; Headache; Ocular hyperaemia; Pain	FLU3~SANOFI PASTEUR~U2457HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297729	11/26/2007	IA	55.0	55		F	11/26/2007	vertigo times 48 hours/ nausea and chills									Y	11/05/2007	11/05/2007	0	none	PUB	PUB	none	none	phenergan, cephalasporins, ct dye duramorph			1						1	Chills; Nausea; Vertigo	FLU3~SANOFI PASTEUR~U2457HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297731	11/26/2007	CO	41.0	41		F	11/26/2007	Reddened rash chest. To Emergency Department for follow up. Took benedryl. Rash started to clear with in 1 hour. No other complications.									Y	10/26/2007	10/26/2007	0		PUB	PVT	none	none	Allergies: Codiene & Hydrocodone			1						1	Rash erythematous	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU315AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0297733	11/26/2007	PA	0.5	0	.5	M	11/26/2007	Patient developed fever starting on the day of vaccine administration that lasted for 6 days. Patient developed diffuse skin-colored maculopapular rash. Mom called 11/24/2007 at 3:30 pm and was seen on 11/26/2007. At that time pt had no fever, did still have the rash. More likely viral illness, reporting because occurred just after vaccination				Y					Y	11/19/2007	11/19/2007	0	n/a	PVT	PUB	Started Nystatin, Tylenol, Motrin	URI with cough at time of vaccination	none			1						1	Pyrexia; Rash maculo-papular; Viral infection	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B128AB~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2477BA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B70143F~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0297734	11/26/2007	VA	25.0	25		F	11/26/2007	Had Flu Shot L Deltoid, 1 half hours later numbness from mid forearm (outer aspect) radiating into l little finger, approx 15 minutes later numbness l side face. 11/11/07- symptoms  persist no improvment - saw physician 11/7 who stated that s/s unlikely to be vaccine related.  11/26 FU with client  sysmtoms decreasing, has put in Workman's Comp Claim  - client's physician ref her to neurologist -  first appointment  12/21 2007				Y					N	11/07/2007	11/07/2007	0	Nil to date	UNK	PUB	Oral Contraception	No	Penicillin Allergy - hives	N/A~ ()~NULL~~In Patient|N/A~ ()~NULL~~In Sibling1|N/A~ ()~NULL~~In Sibling2		1						1	Hypoaesthesia; Hypoaesthesia facial	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78994~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0297735	11/26/2007	IL	24.0	24		F	11/26/2007	Appoximately 2-3 days after receiving flu vaccine began to feel shaky in the morning.  As day progressed became achy and felt she had fever.  Around 7:30 PM began to vomit and have diarrhea.  Symptoms lasted about 10 hours and then subsided.									Y	10/30/2007	11/01/2007	2	None	PUB	PVT	Zoloft and Depoprovera	None	Asthma			1						1	Diarrhoea; Feeling hot; Pain; Tremor; Vomiting	FLU3~SANOFI PASTEUR~U2486AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297736	11/26/2007	OR	34.0	34		F	11/26/2007	Injection site swollen, (5 cm) red, painful despite ibuprofen.  Peak at 4 days after, redness and swelling gone by 8th day, remains tender yet today.									Y	11/16/2007	11/19/2007	3	NA	PUB	PUB		NA	History of asthma, no symptoms several years.			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79717~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C2771AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0297737	11/26/2007	IN	54.0	54		F	11/26/2007	s/s:warmth and swelling at injection site, the left deltoid; pain in left arm and left shoulder.  treatment: prednisone taper, and ibuprofen, percocet, and exercises.				Y					Y	11/12/2007	11/13/2007	1	N/A	PVT	PVT	Climara, Synthroid, Ultracet	NO	Fibromyalgia, Hypothyroidism			1						1	Injection site swelling; Injection site warmth; Musculoskeletal pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2487AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297741	11/26/2007	CA	2.0	2	.6	F	11/26/2007	5 hours following the administration of the Flu Mist, the child began to vomit approximately every 20 minutes which lasted about 8 hours.  Fever started at night, was about 101 degrees and lasted about 10 hours.  She also started to cough.  The rash developed on 11/23/07, about 7 days after the shot was given. Rash began at the ankles, was bright red with what looked like bruising underneath the rash in some areas on her legs.  It continued from her belly button to her elbows.  The rash had very little itching.  When the rash began, patient's mother treated her with benedryl and the redness of the rash faded.  The family was on vacation so the patient was taken to the Clinic.  Blood work was done and her urine was checked.  Mother was told they felt the rash was associated with the Flu Mist nasal vaccine due to the bruised look under the rash on her legs.  The Clinic consulted with a hospital who agreed.  Although the rash has faded, it is still very visible and covers her legs. On the rest of her body, it has almost disappeared.  03/07/2008 MR received for ER visit 11/23/07 with DX: Hypersensitivity vasculitis 2' to FluMist vaccine. Infant presented to ER with rash which was spreading.  Infant had developed vomiting and fever on the day of vax which subsided. PE(+) for confluent, purpuric petechial rash from the waist down.  Impression of Henoch-Schonlein purpura.				Y					U	11/15/2007	11/15/2007	0	Labs and Diagnostics: CBC with WBCs 13.0 otherwise WNL. PT/PTT WNL	UNK	UNK	None	None	None			1						1	Blood test; Contusion; Cough; Pyrexia; Rash; Urine analysis; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500487P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0297742	11/26/2007	MO	63.0	63		M	11/26/2007	At first I had a sore throat and cough. The cough would not go away and just go worse over the next 3 days until I was very sick and hardly being able to breathe with chest congestion and 100.5 fever by Thanksgiving day. On Friday, 11/23/2007 I returned to the Physicians Assistant as I was coughing up blood with some mucus. I was given a prescription for Azrithromycin and told to use my rescue inhaler frequently. The antibiotic has had little affect after 4 days. Use of the rescue inhaler has helped some, but I am still sick. HHS has been very negligent in not spreading the word that there was a differnt formulation of flu shot vaccine for people with severe allergies. I am not and have never been allergic to eggs. It is the dam Mercury and preservatives that are the problem.				Y					N	11/17/2007	11/18/2007	1		UNK	UNK		None	penicillin, ether, sulfites, nitrites	none ever~ ()~~0.00~In Patient		1						1	Cough; Dyspnoea; Haemoptysis; Malaise; Pharyngolaryngeal pain; Pulmonary congestion; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0297743	11/26/2007	MI	1.3	1	.3	F	11/26/2007	The day of vaccine pt came down with pink eye likely viral.  However the parents describe that the 10 days following the vaccine pt was very much less active that usual.  Indeed in the office pt actively level was quite low.  howevere the night of the 11/16/07 although sent home, from office spiked and fever and became quite dehydrated,  essential a partical septic work-up was done and some viral cultures were drwan and all were negative.  the CRP did get as high as 6.3, but pt was treated with IV hydration and released without antibiotic (was given a dose of rocephin in the ED) .  Was followed the next,following release, day in clinic and was doing well and activity was back to normal. 12/10/07-records received for DOS 11/17-11/18/07-DC DX: Fever, dehydration, tonsillitis. Seen in ED temp 102.3, history of fever times 2 days. Decreased oral intake, decreased urine output,  Cough, nasal congestion.PE: pharyngeal erythema, right and left sided tonsillar erythema, swelling and hypertropy.					Y	1			Y	11/06/2007	11/06/2007	0	At admiossion WBC was 23,000 no bandsm normal Diff.  LYtes were normal,  RSV and influenza were notrmal, CXR and neck Xray were normalm  CRP 6.3,  fever in hospital documented at 102.3 enteroviral PCR were negative, Urine was normal, RSV and GAS testing was normal. 12/10/07-records received- CXR, neck X-ray normal. RSV negative, strep negative, cultures negative. WBC 23.0.	UNK	UNK	none	not noted.  Symptoms begin night after vaccine records received-12/10/07-runny nose on and off for past 7 days.	none			1						1	Blood electrolytes normal; C-reactive protein increased; Chest X-ray normal; Decreased activity; Dehydration; Influenza serology negative; Polymerase chain reaction; Pyrexia; Streptococcal identification test negative; Urine analysis normal; Virus serology test; White blood cell count increased; X-ray normal	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B061AA~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~Ut2460GA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0809U~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1361U~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0297768	11/26/2007	PA				F	11/20/2007	Seriousness Criteria: Other-Medically Significant Initial report received from a healthcare professional on 12 November 2007. A female patient (age not reported) received a flu vaccine (trade name, manufacturer, lot number, route/site of administration not reported) approximately five years ago and within a week developed Guillain-Barre Syndrome (GBS). The patient also develped flu during that same week (time frame for vaccination and development of flu vaccination or of the flu. The patient had not fully recovered. No additional information was provided at the time of this report.				Y					N	01/01/2005	01/01/2005	0		UNK	UNK					200703838	1						1	Guillain-Barre syndrome; Influenza	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0297772	11/26/2007	PA				M	11/19/2007	This case was received from a health professional on 08 November 2007. A male patient received a dose of Fluzone (lot number not reported) on an unknown date. He complained of weakness, and subsequently developed shingles. He was admitted to the hospital. The reporter did not have any additional information.					Y	0								UNK	UNK					200703805	1						1	Asthenia; Herpes zoster	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0297773	11/26/2007	NC	81.0	81		F	11/19/2007	This case was received from a health professional on 08 November 2007. An 82-year-old female patient received an intramuscular left deltoid injection of Fluzone (U2486AA). The patient had a history of hypertension, glaucoma, restless leg syndrome, depression, factors deficiency, osteoarthritis, increased cholesterol, and reaction to codeine; concomitant medications included Niacin, Restoril, Lasix, Hydrochlorothiazide, LoBid, Phenergan, Prinivil, Daypro, Aspirin, Indapamide, and hydralazine. The patient received the injection in the morning of 06 November 2007, and in the evening began experiencing hives and angioedema of the face, neck, and abdomen. She was seen by her physician on 07 November 2007, and treatment included Benadryl 25 - 50 mg every six hours. At the time of the report, the patient had not yet recovered.				Y					N	11/06/2007	11/06/2007	0		PVT	PVT	Niacin, Restoril, Lasix, HCTZ, LoBid, Phenergan, Prinivil, ASA, Indapamide, Hydralazine, Daypro		Hypertension, glaucoma, depression, high cholesterol, factors deficiency, osteoarthritis, restless leg syndrome, reaction to codeine; no illness at the time of vaccination.		200703806	1						1	Angioedema; Urticaria	FLU3~SANOFI PASTEUR~U2486AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297775	11/26/2007	TX				U	11/19/2007	Seriousness Criteria: Other-Medically Significant Initial report received from a health professional on 08 November 2007. A patient (age and gender not reported) received Fluzone (Lot number, administration date and route/site not reported) and developed a possible nerve problem in that limb (onset date not reported). No additional information had been provided at the time of this report.				Y					U					UNK	UNK			It was unknown if the patient had any illness at the time of vaccination, unknown if the patient had any pre-existing medical conditions/allergies and unknown if the patient was taking any concomitant medications.		200703818	1						1	Nerve injury	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297776	11/26/2007	LA				F	11/19/2007	This case was received from a health professional on 08 November 2007.  Seriousness Criteria: Other-Medically Significant A female patient received an injection of Fluzone (lot number not reported), and later developed immune or idiopathic thrombocytopenia purpura. The reporter felt did not provide any additional information.				Y										UNK	UNK					200703819	1						1	Idiopathic thrombocytopenic purpura	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297778	11/26/2007	IL				M	11/19/2007	This case was received from a health professional on 09 November 2007. Seriousness Criteria: Other-Medically Significant A male patient in his early 40's, with a history of aortic dissection and aortic valve replacement, received an intramuscular left deltoid injection of Fluzone (lot number not reported). Approximately one week after vaccination, the patient developed left arm pain radiating to the left side of his neck. The pain became increasingly worse, and the patient was referred to an orthopedic doctor, who diagnosed him with Parsonage-Turner Syndrome. Treatment included pain medication and physical therapy twice a week. Concomitant medications included warfarin, and the reporter noted that the patient received annual flu vaccinations. At the time of the report, the patient had not yet recovered.				Y					N					PVT	PVT	WAFARIN		History of aortic dissection and valve replacement; no illness at time of vaccination.		200703823	1						1	Neck pain; Neuralgic amyotrophy; Pain in extremity	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297789	11/26/2007	CO	8.0	8		F	11/15/2007	Pt received varicella (Varivax) vaccination at 10am on 11/14/07. Approximately 5 hours later, she developed cough, itching, swelling and redness at injection site. On 11/15 am awoke with bilateral eye swelling, on pm of 11/15, developed hives on bilateral lower legs.				Y					U	11/14/2007	11/14/2007	0		PVT	PUB	Albuterol	None	Cerebral Palsy			1						1	Cough; Eye swelling; Injection site erythema; Injection site swelling; Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U2502AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1173U~3~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0297796	11/26/2007	UT	67.0	67		M	11/19/2007	urticaria-widespread-Lg welt like hives arms and legs worst areas Dry mouth, feels tongue feels thick onset 2 hr after injection for 48 hrs then improved				Y					Y	11/15/2007	11/15/2007	0	physical exam-started on Benadryl QID x 3 days-Resolved	OTH	OTH	Metformin, Simvastatin Glipizide, Enalapril	None				1						1	Dry mouth; Tongue disorder; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA026AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0297797	11/26/2007	TX	71.0	71		F	10/18/2007	Vaccine administered 10/14/07 by a pharmacy student at about 12 noon. Patient noticed her arm became inflamed and red about 5 pm. It then continued to appear red and became more painful. She visited her physician on the 15th and was started on Rifampin and Clindamycin, she appears to be improving.				Y					Y	10/14/2007	10/14/2007	0		OTH	OTH	unknown	cellulitis	No known allergies			1						1	Erythema; Inflammation; Pain in extremity	FLU3~SANOFI PASTEUR~U2510AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297799	11/26/2007	NJ	59.0	59		F	11/19/2007	Throat began to get hoarse and felt like it may tighten.				Y					Y	11/15/2007	11/15/2007	0	None	PVT	OTH	None	None	None			1						1	Dysphonia; Throat irritation; Throat tightness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78995~5~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0297800	11/26/2007	WI	68.0	68		F	11/19/2007	At 8:30pm felt terrible, right arm swollen, so very sore and red, rash arm down to elbow, could hardly lift it.  Had chills, went to bed at 10:30pm.  Woke up at 4:30am weak, very warm, sweating, felt like vomiting, called husband, passed out in bathroom.  Had big cut on left side of my nose, swollen.  Recovered, except bruised ribs, scar and tender by nose.									Y	10/30/2007	10/30/2007	0		PVT	OTH		None				1						1	Asthenia; Chills; Contusion; Erythema; Face injury; Feeling abnormal; Feeling hot; Hyperhidrosis; Laceration; Loss of consciousness; Mobility decreased; Nausea; Oedema peripheral; Pain in extremity; Rash; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0297803	11/26/2007	TX	59.0	59		F		Site very painful, sharp pain in upper arm, feels like needle is in there (arm).									U	10/31/2007	10/31/2007	0		PVT	OTH						1						1	Injection site pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2466AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297810	11/26/2007	AL	4.0	4		M	11/16/2007	Dtap and IPV given in left lateral thigh on 11.14.07. On 11.16.07 pt presented in the office with a 10cm x 10cm area of redness, swelling and warmth at the site of injections. No tenderness. Pt instructed to apply ice and PO Benadryl.									U	11/14/2007	11/15/2007	1		PVT	PVT						1						1	Injection site erythema; Injection site swelling; Injection site warmth	DTAP~SANOFI PASTEUR~C2760AA~5~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2530AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0273~4~IM~LL~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0297813	11/26/2007	CT	11.0	11		F	11/16/2007	After immunization patient had brief episode of syncope. Resolved completely; Fell to floor but no head injury									Y	11/16/2007	11/16/2007	0		PUB	PUB	none	none	diagnosed contact dermatitis			1						1	Fall; Immediate post-injection reaction; Syncope	FLUN3~MEDIMMUNE VACCINES, INC.~500490P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0928U~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2405AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B021CB~1~IM~LA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1026U~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0297815	11/26/2007	CT	3.0	3		F		Toxic synovitis 11/15/07-seen in ED, given phenerol.  Persistent toxic synovitis 11/16/07-seen in ED, given phenerol.  Intussusception 11/17/07-air enema reduction.  12/21/07 Reviewed hospital medical records which reveal patient experienced abdominal pain, fever & bloody mucous stool after having several episodes of diarrhea.  Had been seen in ER 11/16 for left hip pain & dx w/toxic synovitis.  Tx w/IV naprosin & d/c to home.  Returned to ER s/p bloody stool.  Admitted 11/17-11/18/2007.  Admitted to surgical service for observation s/p enema reduction. FINAL DX: Intussusception, enema reduced.   2/8/08 Reviewed ER medical records of 11/15/07 which reveal patient experienced left leg pain after nap.  Had received flu shot earlier in day in left arm. Not moving or walking normally.  When lying, kept leg flexed at hip/knee & had significant pain when left hip or knee moved.  Improved w/pain meds but continued to limp at D/C.  To be seen by pcp same day. FINAL ER Dx: pain left leg, etiology undetermined.				Y	Y	1			Y	11/15/2007	11/15/2007	0	LABS: US of abd (+) for IS.  Air contrast enema reduced IS.  Granulocytes 63.6% (H), lymphs 28.1% (L). LABS: x-rays of left hip/femur & knee WNL.	PVT	PVT		No	None			1						1	Enema administration; Intussusception; Synovitis; Enema administration; Intussusception; Synovitis	FLU3~SANOFI PASTEUR~U2465AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2465A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0297816	11/26/2007	LA	38.0	38		F	11/15/2007	Full body rash, itching. Treated with over the counter antihistamines									Y	11/13/2007	11/13/2007	0		PVT	UNK		None	None known			1						1	Pruritus; Rash generalised	FLU3~SANOFI PASTEUR~U2452AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297818	11/26/2007	MI	61.0	61		F	11/19/2007	Bells Palsy. 12/13/2007 ER record received for DOS 11/17/2007 with DX:  Bell's Palsy.  Pt presented with L sided facial droop, increased sensitivity of hearing, and eye irritation.  Pt has had difficulty chewing and is unable to whistle. Ptosis and inability to wrinkle forehead noted on PE.				Y					U	11/12/2007	11/16/2007	4	CBC, sed rate - normal	PVT	PVT	Vitamins, Valtrex po	None	None. PMH:Allergy to cortisone.			1						1	Facial palsy; Full blood count normal; Red blood cell sedimentation rate normal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA318CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0297820	11/26/2007	WI	2.0	2	.0	F	11/20/2007	High fever 103.2 degrees and vomiting.  Was taken to the E.R that night.				Y					Y	10/22/2007	10/22/2007	0		PUB	PUB		None	None			1						1	Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~LUT2459RA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1437F~3~IM~UN~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B5884SC~4~IM~UN~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0297821	11/26/2007	TX	7.0	7		M	11/19/2007	N 26 hours after Flu vaccine right arm felt like it was on fire, stinging. Had well demarcated raised very erythematous 5cm X 8cm (prox-distal) hot to touch area over most of the upper lateral arm starting at sire of injection. 36 hours later decreased symptoms with redness, swelling, fading. Benadryl given PRN				Y					Y	11/10/2007	11/11/2007	1		PVT	PVT	Strattera	None	None			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pain in extremity	FLU3~SANOFI PASTEUR~U2493AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297822	11/26/2007	PA	64.0	64		F	11/19/2007	PT. RETURNED 5 DAYS AFTER RECEIVING FLU SHOT STATING THAT ARM WAS BRUISED AND SWOLLEN. IT WAS EXPLAINED THAT THIS COULD BE A NORMAL SIDE EFFECT - BUT PT. WAS UPSET. PT. WAS REFUNDED BECAUSE OF CUSTOMER SERVICE									Y	11/12/2007	11/17/2007	5		UNK	PVT						1						1	Contusion; Oedema peripheral	FLU3~SANOFI PASTEUR~U2493AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297824	11/26/2007	NY	1.0	1	.0	M		fever to 102 deg developed <12 hrs after vaccine				Y					U	11/19/2007	11/19/2007	0	None	OTH	PUB		None	None			1						1	Pyrexia	FLU3~SANOFI PASTEUR~C2440AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0002U~3~IM~RL~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~B08700C~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0297825	11/26/2007	PA	70.0	70		F	11/20/2007	Nausea the next day for 2 weeks. Then I came down with sore throat, cold, cough, tiredness, and to the day I am still coughing- have been sick for over a month so far.									N	09/24/2007	09/25/2007	1		PVT	PVT		None	HBP, Atrial Fibrillation, High Cholesterol			1						1	Cough; Fatigue; Nasopharyngitis; Nausea; Pharyngolaryngeal pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0297826	11/26/2007	AL	45.0	45		F	10/26/2007	Shot was given at 2:00pm.  At 4:00pm noticed pain in right side of neck (lymph gland)-fever, chills, muscle & organ pain resulted after a bath at 8:00pm.  Took Motrin at 9:00 and had horrible symptoms until next morning.  Took Motrin again around 5:00am and then better.										10/23/2007	10/23/2007	0	None	PVT	PVT	Zyrtec, Loestrin and multivitamin	None	None			1						1	Chills; Lymph node pain; Myalgia; Neck pain; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2442AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297827	11/26/2007	GA	46.0	46		F	11/20/2007	Extreme headache; 102 degree fever; joint pain.  Extreme pain in arm at injection site-red, swollen, fever in arm.  Treatment: shot of antibiotic & shot of steroid for cellulitis 11/19 pm.				Y					N	11/15/2007	11/16/2007	1	None	OTH	PVT	Janel Fe birth control	None	None			1						1	Arthralgia; Cellulitis; Headache; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0297830	11/26/2007	NJ	68.0	68		M	11/26/2007	210 pm 10/4: Decreased fever, chills, pain injection site. Fri AM 10/5: arm swollen red, painful injection site to wrist; unable to lift above head and could not wear wristwatch. Sat 10/6: Fever and chills gone, swelling decreasing, pruritus starts. Takes antihistamines. Tues 10/9: All sx gone, arm better.									Y	10/04/2007	10/04/2007	0	None	PVT	PVT	Benicar, Verapamil, Vytorin, ASA, Advair, Neosporin	No	HTN, Increased lipids, Asthma			1						1	Chills; Injected limb mobility decreased; Injection site erythema; Injection site pain; Oedema peripheral; Pain in extremity; Pruritus; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80432~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~09620~2~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297831	11/26/2007	MI	47.0	47		F	11/12/2007	Migraine 1 day after, hives 2 days after.									Y	11/09/2007	11/10/2007	1		OTH	OTH		None				1						1	Migraine; Urticaria	FLU3~SANOFI PASTEUR~B2526AA~2~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297833	11/26/2007	CA	53.0	53		F	11/21/2007	Local redness, pain and swelling of right deltoid beginning evening of day received pneumococcal vaccine.										11/20/2007	11/20/2007	0		PUB	UNK						1						1	Erythema; Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79489~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~9733401~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297834	11/26/2007	MO	60.0	60		F	11/26/2007	Hot flashes, lightheaded, swollen, red around injection, broke out in a rash, sore, bruised, whole arm swollen, numb x 2 wks, initially, heart beat rapid, dizziness (Pt stated) (no RN assess)									Y	10/30/2007	10/30/2007	0	None	PUB	PUB	Synthroid, ASA	None	Erythromycin, Naproxen, Septra, Cipro Amoxicillin			1						1	Contusion; Dizziness; Hot flush; Hypoaesthesia; Injection site erythema; Injection site swelling; Limb discomfort; Oedema peripheral; Palpitations; Rash	FLU3~SANOFI PASTEUR~U2486AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297836	11/26/2007	TX	7.0	7		F	11/24/2007	Mom Called approx 90 min after vaccine and reported hives beginning at vaccine site and spreading to legs and trunk. TX with Benadryl and Baking soda baths.									Y	11/10/2007	11/10/2007	0		PVT	UNK		None				1						1	Injection site urticaria; Rash	FLU3~SANOFI PASTEUR~U2460CA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297837	11/26/2007	IL	15.0	15		M	10/31/2007	Thrombocytopenia - transient									Y	10/11/2007	10/21/2007	10	Platelets 66k 10-21-07;platelets 190k 10-28-07	UNK	UNK		Acne	Acne			1						1	Platelet count decreased; Thrombocytopenia	FLU3~SANOFI PASTEUR~U2452AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297838	11/26/2007	OH	3.0	3		M	11/26/2007	Happened in (R) thigh the evening following administration pt had significant swelling (R) thigh was described the swell to twice its size and was very red and hard. Stayed this way for 16 hours, then deceased.									Y	11/09/2007	11/09/2007	0		PUB	PUB	Albuterol, Omnicef	Sinusitis/Reactive Airway Disease				1						1	Erythema; Injection site erythema; Injection site induration; Injection site swelling; Oedema peripheral	DTAP~SANOFI PASTEUR~U2289BA~4~UN~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2527AA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~04950~1~UN~RL~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~1175U~1~UN~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0297839	11/26/2007	WI	5.0	5		M	11/23/2007	Hand/foot pain Urticaria				Y					Y	11/09/2007	11/10/2007	1	None	PVT	PVT		URI	None			1						1	Pain in extremity; Urticaria	DTAP~SANOFI PASTEUR~U2291BA~5~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2530AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0547~4~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0746U~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1361U~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0297841	11/26/2007	IL	75.0	75		F	11/26/2007	4 hrs after receiving injections pain started in left arm. Pain from neck to hand. Scale 0-10 - Rated 9 in intensity - continued to be in pain for 48 hours. Still has soreness in shoulder to date. Used ice packs PRN 48 hours. Did not contact physician.									N	11/05/2007	11/05/2007	0	None done	PUB	PUB	Diavan, Atenolol, Paxil, Lipitor		Allergies - trees - mold - dusts- cats - hogs - food allergies - scallops			1						1	Musculoskeletal pain; Neck pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80073~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1132U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297842	11/26/2007	CO	38.0	38		F	11/08/2007	15 cm induration and clearly erythema at left deltoid.				Y					Y	11/05/2007	11/06/2007	1	None	OTH	PVT	Zoloft, Effexor, Synthoid	None	Hypothyroid, Depression			1						1	Erythema; Induration; Medication error; Wrong drug administered	DTAP~SANOFI PASTEUR~C2690AA~UNK~~LA~DTAP (DAPTACEL)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA317BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0297843	11/26/2007	CA	66.0	66		M		Recovering well from URI with bronchitis.  Following IZZ c/o worsening cough & shortness of breath evening of IZZ until 3 d later visited clinic for same.  No sx improvement with Xopenex x2.  Have on prednisone taper & Zithromax.				Y					Y	11/13/2007	11/13/2007	0	None	PUB	PUB	cheratussin, Azmacort, Xopenex, benzonatate, Mirapex, prednisone, azithromycin, fluoxetine, Topamax	Recovering from URI, no fever	Milk allergy, asthma, arthritis, hyperlipidemia, mild osteopenia			1						1	Bronchitis; Cough; Dyspnoea; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~U2504AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297844	11/26/2007	AK	59.0	59		M	11/23/2007	11/21/07 local reaction left deltoid, heat, red, swollen dollar size coin at injection site. 11/22/07 local reaction - swollen, hot and red area 7 inches in length, very tender/pain. 11/22 systemic reaction, myalgia, malaise, fever, joint pain and headache.									Y	11/20/2007	11/21/2007	1		PUB	PUB		None				1						1	Arthralgia; Headache; Injection site erythema; Injection site pain; Injection site reaction; Injection site swelling; Injection site warmth; Malaise; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U2435AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0380U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297847	11/26/2007	NY	57.0	57		F	11/19/2007	Awoke at 12:30 A.M. 11/10/07 with extreme itching and redness in left arm elbow joint. Itching progressed and spread to both arms, chest, neck and left side of face. 11/11/07 Hives broke out on arms, chest, back, neck and left side of face. Lasted until 11/14/07. Tried Benadryl.									Y	11/09/2007	11/10/2007	1		OTH	OTH	Morphine	None	NSAIDS			1						1	Erythema; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2441AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298071	11/26/2007	MT	31.0	31		F	11/21/2007	Received infection from shot.				Y						11/19/2007	11/19/2007	0		OTH	UNK						1						1	Infection	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0297375	11/27/2007	VA	5.0	5		M	11/27/2007	Severe cough began after 24hrs, followed by fever ranging from 101-104.  Cough worsened into vomiting.  Sought care via local ER and was diagnosed with pneumonitis and pneumonia in right lung.  He was given the FluMist under the recommendation of the clinic nurse knowing that he has reactive airway disease.  He should have NEVER received.  There needs to be warning labels and proper education of the administers.				Y					N	11/14/2007	11/15/2007	1	Chest xray to prove pneumonia	MIL	MIL	Extendryl, Nasonex, Singulair	None	Environmental allergies, reactive airway disease	None~ ()~~0.00~Patient|None~ ()~~0.00~Sibling		1						2	Cough; Lobar pneumonia; Pneumonitis; Pyrexia; Chest X-ray abnormal; Cough; Pneumonia; Pneumonitis; Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500484P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Emergency room visit	Influenza
0297801	11/27/2007	WI	5.0	5		M	11/27/2007	Fever over 103 F for two days									Y	11/20/2007	11/21/2007	1	None	PVT	PVT	None	None	None			1						1	Pyrexia	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B061AA~5~IM~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2510AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0526U~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0297817	11/27/2007	FL	62.0	62		M	11/27/2007	Received flu shot Nov 9, and Nov 21 was diagnosed with shingles.									N	11/09/2007	11/21/2007	12		UNK	PVT		NONE				1						1	Herpes zoster	FLU3~SANOFI PASTEUR~U2451AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297851	11/27/2007	OH	0.5	0	.5	M	11/27/2007	3 DAYS FOLLOWING VACCINE, PATIENT HAD A 30 SECOND SEIZURE-LIKE EPISODE				Y					Y	11/06/2007	11/09/2007	3	ELECTROLYTES - NL.  MRI - NL.  EEG - NL	PVT	PVT	PREVACID	NONE	GERD			1						1	Blood electrolytes normal; Convulsion; Electroencephalogram normal; Nuclear magnetic resonance imaging normal	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B125BB~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2456BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~854007E~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0973U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0297854	11/27/2007	MD	74.0	74		F	11/27/2007	Pt received Influenza Vaccine at 0945 on 26 Nov 07.   9:00pm on 26 Nov 07 the day she received the vaccine she started to feel weak and dizzy, went to bed and slept all night.  At 0645am she got up and started to feel very dizzy.  No vomiting, denies aches, fever. However she does report tiredness and very subtle chills.   She states after lying back down she felt better, but the minute she moves she gets dizzy. It is now 0830 on 27 Nov and pt states the dizziness is a little bit there, all the time.  Strongly urged to follow-up with primary care physician.   Follow up phone call at 1130 awakens pt who reports she is not dizzy, but had not been out of bed again.  She reports she is going to call her physicians office for guidance.									U	11/26/2007	11/26/2007	0	none at this time.	MIL	MIL	none	none	none			1						1	Asthenia; Chills; Dizziness; Fatigue	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA282EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0297858	11/27/2007	VA	59.0	59		M	11/27/2007	Recieved flu vaccine on 11/17/07 and within 72 hours noticed clear fluid draining from both ears.  Resolved within 24 hours.  Had low grade fever and general aches/pains that on 11/27/07 are still present.									Y	11/17/2007	11/20/2007	3		MIL	MIL	HCTZ		HTN			1						1	Otorrhoea; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA050AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0297859	11/27/2007	MO	86.0	86		F	11/20/2007	Two days after pneumonia shot - right arm swelled, was red, warm adn painful.  Couldn't use it for three or four days.  Sweling was in the mid upper arm.									Y	10/18/2007	10/20/2007	2		UNK	UNK		No	No allergies to med. etc.		MO200739	1						1	Erythema; Hypokinesia; Oedema peripheral; Pain in extremity; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA036AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0961U~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297860	11/27/2007	MO	56.0	56		M	11/09/2007	Clients arm started sweeling and hurting 9:00 p.m. - 11-2-07.  He couldn't sleep - couldn't lift his arm or wear his shirt.  The arm was swollen down to his hand.  He went to the ER 11-05-07 and was given a steroid injection and pain meds.  He started having some relief that evening and gradually felt better.  Missed several days of work.				Y					Y	11/02/2007	11/02/2007	0		UNK	UNK		No	No		MO200740	1						1	Injected limb mobility decreased; Oedema peripheral; Pain in extremity; Sleep disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~80073~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0963U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0297863	11/27/2007	CA	54.0	54		M	11/27/2007	Strong allergic reaction:  breakout of skin throughout most of body, boils, legions.				Y					U	11/14/2007	11/15/2007	1		UNK	PVT	Lotrel, Diovan					1						1	Furuncle; Hypersensitivity; Skin lesion	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81108~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0297864	11/27/2007	MO	68.0	68		F	11/20/2007	Client's arm got sore later in the day after getting pheumonia immunization and stayed sore 7-10 days - no swelling and she did use her arm ok.									Y	10/18/2007	10/18/2007	0		UNK	UNK	Fosamax	No	No - had cancer 3 years ago		MO200742	1						1	Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA036AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0961U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297865	11/27/2007	MO	76.0	76		F	11/20/2007	Client's left upper arm swelled and was sore and warm on the next day after getting pneumonia shot.  It stayed sore and swollen four days.  She had to pick it up with the other had as she couldn't use it.									Y	11/18/2007	11/19/2007	1		UNK	UNK	No	No	NO		MO200743	1						1	Injected limb mobility decreased; Oedema peripheral; Pain in extremity; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA036AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0888F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297866	11/27/2007	NY	56.0	56		F	11/27/2007	Nausea and hot/cold feeling almost immediately and continuing through next day and evening.									Y	11/08/2007	11/08/2007	0		PUB	UNK						1						1	Feeling of body temperature change; Immediate post-injection reaction; Nausea	FLU3~SANOFI PASTEUR~u2473BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297868	11/27/2007	CA	53.0	53		F	11/27/2007	Developed chills, low grade fever, difficulty breathing, malaise (no energy), upper respiratory congestion, then sore throat, and chest congestion starting 22-23 hours after influenza vaccine.  No arm swelling or redness.  Off work for 5 days.  No treatment by primary care, urgent care or emergency care.  Took OTC Nyquil and ibuprofen.  Symptoms improved after five days off work.  No similar symptoms in family around time of her symptoms.									Y	11/02/2007	11/03/2007	1	None.	UNK	UNK	Antihypertensives (3), cholesterol lowering drug, Zantac, thyroid replacement hormone.	None.	High cholesterol, hypertension, hypothyroidism	Flu symptoms~Influenza (Seasonal) (no brand name)~1~51.00~In Patient|None~ ()~~0.00~In Sibling		1						1	Chills; Dyspnoea; Malaise; Pharyngolaryngeal pain; Pyrexia; Upper respiratory tract congestion	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0297870	11/27/2007	PA	44.0	44		F	11/27/2007	I had a huge red reaction at injection site(2 inches across) for 2 weeks and the area is still tender after 4 weeks.  I had horrible joint and muscle pain for 3 weeks and bad fatigue and low grade fevers.  After four weeks I still have bad joint pain, muscle pain, and fatigue.  I've gotten a flu shot every year and this is the first time I've ever had a reaction.									N	10/23/2007	10/24/2007	1		PVT	UNK	Topral XL 50 mg	high blood pressure	breast cancer survivor 2000			1						1	Arthralgia; Fatigue; Injection site erythema; Injection site pain; Myalgia; No reaction on previous exposure to drug; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0297872	11/27/2007	SC	60.0	60		F	11/27/2007	Redness, swelling soreness area approximately 3 diameter.  Hives beginning throat and inside arms and spreading to face and legs.  Duration approximately 3 days.									Y	10/22/2007	10/24/2007	2		PUB	PVT	none	none	Food allergies (scallops) sulfur, penicillin and sulfite allergies.			1						1	Erythema; Pain; Swelling; Throat irritation; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0297874	11/27/2007	IN	7.0	7		M	11/12/2007	A serious report of respiratory distress and wheezing was received from a physician concerning a seven-year-old male. The patient had a history of allergic rhinitis but did not have a history of wheezing or asthma. Concomitant medications include Zyrtec and Flonase nasal spray, both taken once a day for allergic rhinitis since Aug 2007. The patient received FluMist on 16-Oct-2007. On 18-Oct-2007, the patient presented to the reporting physician's office complaining of respiratory distress and wheezing, which started on 17-Oct-2007. The patient's chest x-ray was normal. Per the reporter, the patient cleared with Xopenex but returned later in the day with increased distress. The patient was admitted to the hospital for 24 hours and was discharged on oral steroids and Xopenex treatments. The patient recovered from the wheezing. No outcome was provided for the event of respiratory distress. The discharge summary has not been received. Rechallenge is not applicable. The reporter did not provide an assessment of causality for the events. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.					Y	1			U	10/16/2007	10/17/2007	1	CXR normal	PVT	PVT	Zyrtec, Flonase		Past Disease: Allergic rhinitis		MEDI0006101	1						1	Chest X-ray normal; Respiratory distress; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500488P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0297898	11/27/2007	PA	0.61	0	.6	M	11/08/2007	Fever 101 for 2 days, irritable, crying, waking up in the Middle of the Night. Leg at injection site hot + hard. Tylenol given every 4 hours. 4-3006 gave Hib again. Medical error. Already Had 4 doses. 1/24/08-office records received-well baby visits with C/O tugging at ears seen by audiologist for C/O hearing problem, and cerumen impaction right ear. Per 60 day follow up: My son has vaccine induced autism. 1/15/2010 Developmental delay, poor socialization skills, poor communication skills and multiple allergies.								Y	N	11/08/2005	11/08/2005	0	1/24/08-records received-test revealed normal functional hearing for speech and tones in soundfield. Unable to obtain monaurual information for either ear, a unilateral hearing loss could not be ruled out.	PVT	OTH	Prevacid	GERD - Allergic milk protein	Dx: w GERD/Milk Allergy/Protein, Dx 6/14/2005	Autism~Hib (no brand name)~5~1.00~Patient		1						1	Acoustic stimulation tests abnormal; Autism; Communication disorder; Crying; Developmental delay; Dyskinesia; Ear disorder; Hypoacusis; Inappropriate schedule of drug administration; Injection site induration; Injection site warmth; Irritability; Medication error; Pyrexia; Sleep disorder; Social problem; Vaccination complication	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B022DA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1854AA~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE770AA~4~IM~RL~HIB (ACTHIB)~1	USA	Disabling	Influenza
0297901	11/27/2007	WI	1.43	1	.4	F	11/19/2007	Alone observed or reported. Fluvirin instead of Sanofi vaccine was given.										11/16/2007				PUB	PUB	None	None	None			1						1	Inappropriate schedule of drug administration; Wrong drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80956~1~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0297902	11/27/2007	MN	51.0	51		F	11/21/2007	This 51-year-old presents with a history of having had an influenza injection done 2 days ago on 11/14/07. She had minimal reaction to it during the first 24 hours, but then late yesterday noticed a tender limp in her clavicle and mentioned that at work and was advised that she should come in to be checked. She has had no fevers, chills or sweats. She has minimal discomfort about the injection site. Low grade cellulitis complicating injection.				Y					U	11/14/2007	11/15/2007	1		OTH	PVT	None	None	Lumbar disc herniation			1						1	Cellulitis; Injection site discomfort; Musculoskeletal discomfort	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81111~7+~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0297903	11/27/2007	IL	25.0	25		F	11/22/2007	Pain in right arm				Y					Y	11/13/2007				OTH	PVT						1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2510AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~2~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0297904	11/27/2007	NC	62.0	62		F	11/22/2007	11/18/07 attempted to vaccinate pt with influenza vaccine. It appeared that vaccine was leaking from syringe. Not sure of how much vaccine may have been administered. Contacted CDC regarding situation. CDC did not return call. Called CDC again 11/19/07 and their recommendation was to re-vaccinate pt. Pt came in for re-vaccination 11/22/07. Pt had no complaints and was feeling well.									Y	11/18/2007	11/18/2007	0		OTH	OTH	None	None				1						1	Device failure	FLU3~SANOFI PASTEUR~U2506AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297905	11/27/2007	NC	62.0	62		M	11/22/2007	11/18/07 Attempted to vaccinate pt with influenza vaccine. It appeared that vaccine was leaking from syringe. Not sure of how much vaccine may have been administered; contacted CDC regarding situation and recommendation. CDC did not return call. Called CDC again 11/19/07 and their recommendation was to re-vaccinate pt. Pt came in for revaccination 11/22/07. Pt at the time was feeling well and no complaints.									Y	11/18/2007	11/18/2007	0		OTH	OTH	None	None				1						1	Device failure	FLU3~SANOFI PASTEUR~U2506AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297906	11/27/2007	OH	76.0	76		F	11/21/2007	Vaccine given at 3p US WNI at 7:30p c/o occ. moist productive cough of thich yellow phlegm. Nurse practitioner notified and orders cxr, sputum culture, aerosols and Doxocycline 100 mg bid x 10 dyas Hx of CVA- with hemiparesis rt side. Was going to give vaccine in good arm, but she wanted me to put it in her right. I've never had problems before 11/15/07 Rt arm swollen and red, warm to touch Bruising by elbow Nurse practitioner notified warm compress qid x 4 days									Y	11/12/2007	11/15/2007	3		OTH	OTH	Atrovent, MVI, Flovent, Lasix, K-dur, Lipitor, multivitamin with iron, Paxil, Prevacid, Tylenol		PCN, sulfa, Macrobid			1						1	Chest X-ray; Contusion; Erythema; Oedema peripheral; Productive cough; Skin warm; Sputum culture	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0297907	11/27/2007	PA	55.0	55		M	11/20/2007	Prominent localized swelling at injection site immediately after injection was given (swelling = size of walnut). No other immediate adverse reactions noted by pt. or observed. Ice applied to site x 15 minutes and swelling resolved. I spoke with pt on 11-16-07 and he stated that after flu injection, he had gradually increasing (L) arm pain and swollen lymph nodes over next few days which prompted him to visit his physician on 11-13-07. Physician prescribed Keflex x 10 days and will continue to follow.				Y					Y	11/12/2007	11/12/2007	0	None	PVT	PVT	Unknown	None	None reported by patient			1						1	Immediate post-injection reaction; Injection site swelling; Lymphadenopathy; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA310BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0297910	11/27/2007	CA	10.0	10		M	11/16/2007	3x3 red, hot swollen painful area at (R) arm injection site.									Y	11/13/2007	11/16/2007	3	None	PVT	OTH		None	None			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLUN3~MEDIMMUNE VACCINES, INC.~500486P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~1182U~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0297912	11/27/2007	CA	84.0	84		F	11/17/2007	Swelling, erythema large area left upper arm (at vaccine site)				Y					U	11/15/2007	11/15/2007	0		PVT	PVT		no	no			1						1	Erythema; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79719~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0959F~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0297913	11/27/2007	WY	84.0	84		F	11/16/2007	Influenza IZ 11-13-07 at 1700; by 0400, 11-14-07, experiencing severe, flu-like symptoms. Client called hospital and doctor advised not to take another flu iz. Has had no adverse reactions with past flu shots - notified public health at 10 AM, 11-14-07 - state I'm fine now.									Y	11/13/2007	11/14/2007	1		PUB	PVT		No	Client denies at screening			1						1	Influenza like illness	FLU3~SANOFI PASTEUR~U2512AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297914	11/27/2007	WY	53.0	53		F	11/16/2007	Co. Public Health Mass vaccination exercise, Client vaccinated with 317 vaccine (influenza) about 10 Am. at 6pm that evening experienced difficulty breathing, stated Throat closed called Hospital and Advised to take Benadryl, which resolved situation about 10 pm. Did not go to ER - Called Dr who Advised no flu iz.									Y	11/10/2007	11/10/2007	0		PUB	PUB		No	No			1						1	Dyspnoea; Pharyngeal oedema	FLU3~SANOFI PASTEUR~U2490AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297916	11/27/2007	CA	4.0	4		M	11/16/2007	The patient came in on 11-15-07 with his left arm all swollen and red from the shoulder bone all the way down to his elbow. It was also hot and Mom said that his elbow started to swell on 11-14-07 at night.									Y	11/13/2007	11/14/2007	1		PVT	PVT	Cortisone Creme	None	Allergies: Bactrim, Trees, Cats, Grass			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2473BA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297917	11/27/2007	IN	34.0	34		F	11/20/2007	at approx. 10:25 am had flu shot and about 3:30 pm my throat suddenly felt like it was closing and it was getting harder and harder to swallow as the night went on. I also experienced hoarseness. I went to the emergency room and was treated and release.				Y					Y	10/13/2007	10/13/2007	0	exam	OTH	PVT		None	seasonal allergies			1						1	Dysphagia; Dysphonia; Pharyngeal oedema	FLUX~UNKNOWN MANUFACTURER~80681~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0297920	11/27/2007	VA	50.0	50		F	11/19/2007	(L) upper arm red, swollen, immobile painful. Temperature 102 deg F.				Y					Y	11/16/2007	11/17/2007	1	CBC- WBC 12,000	PVT	PVT		None	CAD, Perocet and Vancomycin allergy			1						1	Body temperature increased; Erythema; Full blood count; Oedema peripheral; Pain in extremity; White blood cell count increased	FLU3~SANOFI PASTEUR~U2513AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0674F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0297922	11/27/2007	WY	41.0	41		M	11/16/2007	10-19-2007; 1000 received flu shot; not feeling well by 1700, presented to ER with s/s respiratory distress, labored breathing; Dx with Pleurisy Treated with high doses Anti inflammatory.				Y					Y	10/19/2007	10/20/2007	1		PUB	PVT	None	None	None			1						1	Dyspnoea; Malaise; Pleurisy; Respiratory distress	FLU3~SANOFI PASTEUR~U2512AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297925	11/27/2007	WA	2.0	2	.2	M	11/16/2007	Three hours after administration, projectile vomiting, fever 103.4 degrees F, apparent discomfort, listlessness.  One-nine days sinus infection (diagnosed).				Y					Y	10/31/2007	10/31/2007	0	None	PUB	PUB	None	None	None			1						1	Discomfort; Listless; Pyrexia; Sinusitis; Vomiting projectile	FLUN3~MEDIMMUNE VACCINES, INC.~500490P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0297926	11/27/2007	FL	50.0	50		M	11/20/2007	Patient administered flumist which is only recommended for patients age 49 and under									Y	11/15/2007	11/15/2007	0		MIL	MIL						1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500488P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0297927	11/27/2007	FL	51.0	51		M	11/20/2007	Pt given flu mist which is only indicated for pts under 49									Y	11/15/2007	11/15/2007	0	N/A	MIL	MIL	N/A	N/A	N/A	N/A~ ()~~0.00~In Patient		1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500476P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0297929	11/27/2007	IA	15.0	15		F	11/20/2007	Nausea, vomiting, dizzy, headache, some arm swelling, tenderness, ? amt of swelling, right arm.									Y	11/14/2007	11/15/2007	1		PUB	PUB	Concerta, Nexium, loratadine, trazodone, Carafate, Advair, Nasonex, pseudoephedrine, Nobalone	None	Pollen, grass, mites, cockroaches			1						1	Dizziness; Headache; Nausea; Oedema peripheral; Seasonal allergy; Tenderness; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80959~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HPV4~MERCK & CO. INC.~0523U~2~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0297930	11/27/2007	WI	57.0	57		F	11/21/2007	Given influenza vaccine 11/19/07. Noted slight redness and warmth to injection site that evening. Reported to Employee Health on 11/21/07 after no improvement.									Y	11/19/2007	11/19/2007	0	None	PVT	PVT	Albuterol; Calcium with Vit D; Premarin; Prozac; Prilosec; Vit E; MVi	None	GERD, COPD, chronic cough			1						1	Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U2450AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297932	11/27/2007	MA	56.0	56		F	11/19/2007	36 hours Following Flu vaccine developed raised red 1 diameter swollen area just below site of injection; Slightly more red and inflamed in past 24 hours. Referred to own Primary Care MD. Pt agrees to call - today.									U	11/17/2007	11/18/2007	1		PUB	PUB	Unknown	None	High Blood Pressure, Type II DM	Fever and Swelling~Pneumo (Pneumovax)~1~49.00~In Patient		1						1	Erythema; Inflammation; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA050AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0297933	11/27/2007	MT	60.0	60		F	11/16/2007	Patient is a paraplegic female who complained of worsening tone/rigidity in bilateral lower extremities after receiving an influenza vaccination 11/12/07.  There was no pain due to hemiparalysis, but a therapist suggested possible adverse event.  The patient has received other vaccinations at this location with no reported complications.									Y	11/12/2007	11/12/2007	0		OTH	PVT		Hemiparalysis/paraplesia	Hemiparalysis/paraplesia.  The patient has received other vaccinations at this location with no reported complications.			1						1	Condition aggravated; Muscle rigidity	FLU3~SANOFI PASTEUR~U2515AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297935	11/27/2007	IN	3.0	3		M	11/16/2007	Left thigh swollen, erythematous warm to touch.  Treated with Keflex, Benadryl 1% hydrocortisone.				Y					U	11/14/2007	11/15/2007	1	None	PVT	PVT		None	None			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2486AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297936	11/27/2007	AZ	9.0	9		F	11/16/2007	Left arm pain for 7 days; Swelling to tricep; no redness, slight warmth to touch, to the bicep area									Y	11/12/2007	11/12/2007	0		PVT	PUB		No illnesses	None			1						1	Oedema peripheral; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~U2476GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297937	11/27/2007	NY	48.0	48		M	11/19/2007	Arm pain x 2 weeks/treated with medrol dose pack.									N	11/01/2007	11/01/2007	0		PVT	PVT			NKDA			1						1	Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~APLLA035AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0297938	11/27/2007	NH	13.0	13		F	11/16/2007	Rec'd vaccine on 11/13/07. On 11/14/07 began with (L) upper arm tenderness. On 11/15/07 seen in office, significant tenderness with about 2 1/2 area of erythema/warmth, painful to move arm - treated with Keflex with improvement.									Y	11/13/2007	11/14/2007	1	N/A	PVT	PUB	None	N/A	N/A			1						1	Erythema; Injected limb mobility decreased; Pain in extremity; Skin warm; Tenderness	FLUN3~MEDIMMUNE VACCINES, INC.~500480P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~MERCK & CO. INC.~0495U~UNK~UN~RA~HEP A (VAQTA)~1|MNQ~SANOFI PASTEUR~U2423AA~UNK~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0297939	11/27/2007	MN	26.0	26		F	11/19/2007	11/17/07 considerable swelling, erythema, warmth & pain in the right upper arm.  Overall fever & malaise.  Reports arm pain, inability to use arm & weakness.  Needs help with all activities.				Y					Y	11/15/2007	11/15/2007	0	Hemogram/Plts/Diff; BP 125/76, P 114, T 102.1 (oral), Resp 20	PVT	PVT	Augmentin 75-125mg x10 days, naproxen (8/2/07), phenothiazine, metoclepramide, ondansetron, Vicodin	None				1						1	Asthenia; Blood pressure normal; Body temperature increased; Erythema; Heart rate normal; Hypokinesia; Laboratory test; Malaise; Oedema peripheral; Pain in extremity; Pyrexia; Respiratory rate; Skin warm	FLU3~SANOFI PASTEUR~U2439AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~20306~1~UN~LA~POLIO VIRUS, INACT. (IPOL)~1|MNQ~SANOFI PASTEUR~U2406AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PPV~MERCK & CO. INC.~0990U~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0297940	11/27/2007	OR	5.0	5		M	11/16/2007	Patient developed severe pain right thigh, unable to bear weight. Fever 101 degrees Thigh tender to touch				Y					U	11/15/2007	11/15/2007	0		PVT	PVT		None				1						1	Pain in extremity; Pyrexia; Tenderness; Weight bearing difficulty	FLU3~SANOFI PASTEUR~UT2459MA~UNK~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0880F~1~UN~RL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0297941	11/27/2007	PA	60.0	60		F	11/16/2007	Received flu vaccine approx 12:30 PM and by 1:30 PM noted beginning of stiff neck by 3:30 PM very uncomfortable. Applied warm moist compresses at home throughout evening. Took Tylenol. By AM neck stiffness subsided.									Y	11/02/2007	11/16/2007	14	None	OTH	OTH	Multivitamin daily; Lipitor 10mg daily	None	High cholesterol x 2 yr			1						1	Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U2513AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297942	11/27/2007	MN	59.0	59		F	11/19/2007	Sudden onset severe fever/chills, shaking woke pt from sleep.  Developed redness & swelling R arm to elbow & up to neck, wheezy breathing & throat swelling.  Took Tylenol.  Office exam 11/19/07-residual redness R upper arm.  Recovering as of 11/19/07				Y					Y	11/16/2007	11/17/2007	1	None	PVT	UNK	ASA, Omega 3, diltiazem, Niaspan, simvastatin, atenolol, estrogen-test, Zyrtec, Rhinocort & nasal spray	None	HTN, obstruct. hypertrophic cardiomyopathy, dyslipidemia, stinging insect allergy, narcotic allergy	fever & vomiting~Influenza (Seasonal) (no brand name)~UN~5.00~In Patient		1						1	Chills; Erythema; Oedema peripheral; Pharyngeal oedema; Pyrexia; Tremor; Wheezing	FLU3~SANOFI PASTEUR~U2514AA~2~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0698U~1~UN~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2842AA~2~UN~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0297944	11/27/2007	FL	5.0	5		F	11/12/2007	Urticaria over (L) upper arm. Swelling, muscle soreness. Treatment - Ibuprofen, Benadryl PRN.				Y					U	11/08/2007	11/10/2007	2		PVT	PUB	None	None	None			1						1	Myalgia; Oedema peripheral; Urticaria	FLU3~SANOFI PASTEUR~A2523AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0297945	11/27/2007	MI	70.0	70		M	11/19/2007	Fatigue, myalgias, nausea, tachycardia, fever to 102.8, intense left arm erythema, pain, and edema.				Y					Y	11/16/2007	11/16/2007	0	WBC 18k, 90% segs	PVT	PUB	Norvasc, ASA K-Dur, Atacand, Tenorelic, simvastatin, C0Q10, MVI	None	Have lung ca, CAD, have melanoma, HTN, Colon adenoma			1						1	Erythema; Fatigue; Myalgia; Nausea; Oedema peripheral; Pain in extremity; Pyrexia; Tachycardia	FLU3~SANOFI PASTEUR~42505AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~13444~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0297946	11/27/2007	CT	4.0	4		M	11/20/2007	Seen 11/13 for 4yr ckup and vaccines. Fine x 24 hours w/o fever, however 11/15/07 while at babysitter had generalized seizure, eyes rolling back, tonic clonic movements of both arms and legs decreased LOC, no respiratory compromise or color change. Lasted 10 min. 911 called, taken to ED.				Y					Y	11/13/2007	11/15/2007	2	neuro referral CT head-negative/for EEG	PVT	PUB	Aclovate 0.05 topical cream	Eczema	Speech delays/PPD-Pervasive Development Disorder			1						1	Convulsion; Depressed level of consciousness; Electroencephalogram normal; Gaze palsy; Scan brain; Tonic clonic movements	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B062AA~5~UN~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2476HA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0111~4~UN~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0412U~2~UN~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1351U~2~UN~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0297951	11/27/2007	MI	47.0	47		F		Rapid-onset pain and erythema in R arm, with heat, fever to 100.4, myalgias, and pleuritic chest pain.				Y					Y	10/24/2007			None	PVT	PUB		Postnasal drip	Stage 1A lung cancer, hypothyroidism			1						1	Erythema; Myalgia; Pain in extremity; Pleuritic pain; Pyrexia; Skin warm	FLU3~SANOFI PASTEUR~U2439AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1344U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0297953	11/27/2007	NJ	47.0	47		F	11/20/2007	Was dizzy, B/P started (R) = 70/40 - 1:15 PM. Given ammonia at 1:15 PM. At 1:27 PM, BP = 110/68; 1:35 PM = 118/70 - I feel great.Nurse recommended to the patient was to seek physician't care if necessary.									Y	11/13/2007	11/13/2007	0	None	PUB	PUB	Unknown	Dizziness	May have felt dizzy at prior flu shots.		NJ200710	1						1	Blood pressure decreased; Dizziness	FLU3~SANOFI PASTEUR~U2448AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0297954	11/27/2007	MN	45.0	45		F	11/19/2007	was getting report from staff and noted tingling and swelling in her lip and extreme itching in her varicose veins of legs. This started 45 minutes after receiving flu vaccine. Co worker gave her Benadryl and symptoms subsided within 30 minutes experienced extreme fatigue for 4 days following episode. Did not seek medical attention. Reported only.									Y	11/09/2007	11/09/2007	0	None	MIL	PVT	None	None				1						1	Fatigue; Lip swelling; Paraesthesia oral; Pruritus	FLU3~SANOFI PASTEUR~U24880ca~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298065	11/27/2007		64.0	64		M	11/27/2007	We received on 14 NOV 2007 via from a healthcare professional the following information: A 64-year-old male patient born on 11 MAY 1943, was vaccinated i.m. with 0.5 ml Fluvirin (batch no. unknown) on 17 OCT 2007. The patient experienced on 05 NOV 2007 confusion and delirium. In the emergency room they have found a high ammonia level. The patient was discharged after a brief hospitalisation. The outcome is unknown. Company assessment: Seriousness criterion: hospitalisation. Causality: insufficient data There is no timely relationship (19 days p.v.) and no plausible pathomechanism to assume a relatedness. Expectedness assessment according to health authority and product information: The described symptoms are unexpected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measures necessary. Regulatory no. :NA07-006414  2/19/08 Reviewed hospital medical records which reveal patient experienced delirium & hyperammonemia.  Admitted 11/5-11/7/2007.  Improved w/med changes.  D/c to home & pcp f/u. FINAL DX: delirium due to hyperammonemia, resolved; acute prerenal azotemia; fatty liver; dementia; morbid obesity (BMI 42); Type 2 DM; carotid stenosis; dyslipidemia.					Y	2			Y	10/17/2007	11/05/2007	19	LABS: ammonia 157.  Creatinine 1.6.  Abdominal US nondiagnostic.  Abdominal CT scan revealed pancreatic atrohy & fatty liver.	OTH	OTH	No other medications	Unknown	PMH: Type 2 DM poorly controlled, obesity, vascular dementia, remote hx of extremely heavy ETOH abuse.  Hx of delirium & hyperammonemia s/p 2006 flu shot.		MA20071409	1						1	Confusional state; Delirium; Abnormal behaviour; Alcohol abuse; Ammonia increased; Blood glucose increased; Computerised tomogram abnormal; Delirium; Feeling abnormal; Hepatic steatosis; Hyperammonaemia; Laboratory test; Nausea; Pancreatic atrophy; Retching	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~SC~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0298066	11/27/2007		67.0	67		M	11/27/2007	We received on 14 NOV 2007 via regulatory authority from a consumer the following information: A 67-year-old male patient with known coronary artery bypass graft in 2006, born on 29 OCT 1940, was vaccinated i.m. with 0.5 ml Fluvirin (batch no. unknown) on 04 NOV 2007. The patient experienced 45 minutes later increased heart rate and increased blood pressure (170 mmHg). The patient was hospitalised on 04 NOV 2007. The outcome is unknown Company assessment: Seriousness criterion: hospitalisation. Causality: not related. There is no association between Fluvirin vaccination and increased heart rate and blood pressure. It must be seen in connection with her cardiac disease. Expectedness assessment according to regulatory authority and product information: The described symptoms are unexpected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measures necessary. Regulatory authority no.: NA07-006431					Y	0			U	11/04/2007	11/04/2007	0		OTH	OTH	No other medications	Unknown	Coronary Artery Bypass		MA20071408	1						1	Blood pressure increased; Heart rate increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0298068	11/27/2007	MA	79.0	79		F	11/27/2007	cellultis on left arm swollen, red down to the wrist 3 IV treatments and oral antibiotics				Y					Y	11/20/2007	11/20/2007	0		PUB	PUB	Protonix Toprol eye drops-Lumigin	None	heart disease w/2 stents			1						1	Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~U2526AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298072	11/27/2007	NC	3.0	3		M	11/05/2007	Vaccine reaction - 1-2 minutes after vaccines. (1) RASH (2) choking (3) gagging (4) sticking out tongue. Epi pen Jr and Benadryl 25 mg IM given. O2 with albuterol given. Call to EMS for transportation. O2 Sat 100% pulse 143. B/P 80/60 Alert awake.				Y					Y	10/05/2007	10/05/2007	0		PVT	PUB		None	LATEX.		NC07116	1						1	Blood pressure; Choking; Dyskinesia; Heart rate; Rash; Retching	FLU3~SANOFI PASTEUR~U2479BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0185U~2~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1335U~2~SC~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0298073	11/27/2007	NC	5.0	5		F	11/15/2007	Angioedema within 2 hours of vaccine involving hands/feet/elbow/knees.  Urticaria as well within 10-15 hours, extensive case.									U	11/14/2007	11/14/2007	0		PVT	PUB	Amoxicillin	Cough	Allergic rhinitis		NC07117	1						1	Angioedema; Urticaria	FLU3~SANOFI PASTEUR~U2479BA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300346	11/27/2007	KY	3.0			M	10/11/2007	A non-serious report of medication error has been received from a nurse concerning a three-year-old male. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The patient had a medical history of Down's Syndrome. No concomitant medications were provided. While the FluMist was being administered, the patient was jerking and moving. As a result, the patient received only a partial dose of FluMist and some went into the patient's eye. No symptoms were reported. No outcome for the event was provided by the reporter. The patient did not experience a rechallenge while receiving the suspected product. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  A non-serious report of partial dose of vaccine given and some got into eyes has been received from a nurse concerning a three-year-old male. The patient received FluMist on 11-Oct-2007. This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The nurse stated that she is not even sure that the patient actually got FLUMIST into his eyes since he did not even wipe his eyes after the FLUMIST was administered. The nurse stated that she reported the incident because the patient's mother was convinced that some of the FLUMIST went into the patient's eyes. The patient was seen in the pediatricians office on a date after the incident and did not report any adverse events. The patient had not experienced any adverse event(s) as of 21-Feb-2008. The events were resolved on 11-OCT-2007. The patient did not experience a rechallenge while receiving the suspect drug. The reporter provided no causality assessment for the event. The reporting sources of this case is spontaneous, thus the sponsor's comment is not applicable. Additional information received 27-Nov-2007: No adverse events resulted after the patient received FLUMIST; information regarding the administration. Additional information received on 21-Feb-2008 and incorporated into the case: patient demographic information corrected, date of birth, date of administration of FLUMIST, and lot number.									Y		10/11/2007			OTH	OTH	Concomitant Drug(s) Not Reported	Down's syndrome			MEDI0006063	1						1	Dyskinesia; Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~500487P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0300347	11/27/2007	AL	1.8	1	.8	F		A non-serious event of vaccine administration error has been received from a nurse concerning a 21-month-old female child. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The child has a medical history of asthma. No drug history information has been reported for this patient. The child received Flumist intranasally. The reporter indicated this child was inadvertently administered Flumist; the child did not meet Flumist labeling requirements. No adverse events were observed. Outcome: the child had no ill effects. Further dosing with Flumist is not indicated. The reporter did not provide a causality assessment for this medication error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 4/15/08 verified no adverse event experienced; lot # 500486E and vaccine administration date is Oct 10, 2007. The child received FLUMIST on 10-OCT-2007. The reporter indicated this child was inadvertently administered FLUMIST; the child did not meet FLUMIST labeling requirements. No adverse events were observed. Outcome: the child had no ill effects. On 12-Feb-2008 it was verified the child had no adverse events. Further dosing with FLUMIST is not indicated. The reporter did not provide a causality assessment for this medication error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow up obtained on 12-Feb-2008 verified the child expereinced no adverse events; corrected the child's initials and date of birth and provided the date of FLUMIST dosing.									Y	10/10/2007				PVT	PVT	Concomitant Drug(s) Not Reported	Asthma	NI		MEDI0006064	1						1	Inappropriate schedule of drug administration; Inappropriate schedule of drug administration; Medication error; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500486E~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0300348	11/27/2007	TX	2.0	2	.3	M	10/30/2007	A non-serious report of malaise and fever has been received from a consumer concerning a 28-month-old male. This case is submitted in accordance with Medimmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The reporter denied the child had medical conditions or took concomitant medications. The child received FluMist on 16-Oct-2007. Two days later on 18-Oct-2007, the child awoke with malaise and fever of 102-102.5 degrees Fahrenheit. The events resolved on 19-Oct-2007. FluMist rechallenged is not applicable. The reporter did not provided a causality assessment for the adverse events reported. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 4/15/08; Lot number of vaccine is not provided, Mar 7, 2008.									Y	10/16/2007	10/18/2007	2		OTH	OTH	Concomitant Drug(s) not reported				MEDI0006098	1						1	Inappropriate schedule of drug administration; Malaise; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0300349	11/27/2007	TX	2.0			M	10/23/2007	Medi0006106 is a non-serious spontaneous case from a physician of fever concerning a two-year-old male.  This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  There was no medical history or concomitant medications for this patient.  The patient initiated Flumist on an unreported date.  Approximately 10 hours following administration of Flumist, the patient experienced fever of 102.6, that increased to 104.3 approximately 20 hours from the time of administration.  No further information was provided.  The event of fever resolved within 48 hours of onset of symptoms.  Action taken with Flumist was not provided.  The reporter did not provide a causality assessment for the adverse event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow up received 4/15/08. Patient date of birth, adverse event onset date/time, lot number for vaccine, and vaccine administration date/time are not provided, 03/07/08.									Y					UNK	UNK	None		None		MEDI0006106	1						1	Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0300350	11/27/2007	OH	1.9			U		A non-serious report of vaccine administration error was received from a nurse concerning a 21-month-old. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No relevant medical or drug history information was reported. The infant was given FluMist on 29-Oct-2007. FluMist was administered to the 21-month-old in error as the vaccine is indicated in patients 2 years to 49 years of age. No adverse events were reported from this error. No additional information is available. Rechallenge is not applicable. Causality assessment is not applicable. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 4/15/08. Patient date of birth and lot # for vaccine is not provided, 03/07/08.									Y	10/29/2007	10/29/2007	0		PUB	OTH	Concomitant Drug(s) Not Reported		NI		MEDI0006122	1						1	Inappropriate schedule of drug administration; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0300351	11/27/2007	OH	1.8	1	.8	U	10/30/2007	A non-serious report case was received from a nurse concerning a 18-month-old and a vaccine administration error. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. No relevant medical or drug history information was reported. The infant was given FluMist on 29-Oct-2007. The reporting site administrated FluMist to the 18-month-old in error as the vaccine is indicated in patients 2 years to 49 years of age. No adverse events were reported from this medication error. No additional information is available. Rechallenge and causality is not applicable. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 4/15/2008.  Patient date of birth is 01/11/06 and lot number of vaccine is not provided, 03/07/08. 13-NOV-2007 follow up information obtained and incorporated in above narrative: No adverse events after receiving vaccine.									Y	10/29/2007	10/29/2007	0		UNK	UNK	Concomitant Drug(s) Not Reported		NI		MEDI0006123	1						1	Inappropriate schedule of drug administration; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0300352	11/27/2007	MN	3.0	3		F	10/30/2007	A non-serious report of vaccination error has been received from a physician concerning a three year-old female. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The child has a history of allergy to eggs, no drug history information has been reported for this child. The patient received FLUMIST intranasally. On 29-Oct-2007 the reporter indicated a child with a history of allergy to eggs was inadvertently administered FLUMIST. No adverse events were observed. Outcome: the child had no ill effects verified on 04-Feb-2008. Further dosing with FLUMIST is not indicated. The reporter did not provide a causality assessment for this vaccination error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow up information was received 4-15-08. Adverse event onset date, states no adverse event reported and lot for vaccine is 500490P, 2/11/08. Follow up obtained on 06-Feb-2008 verified no adverse event was experienced and the physician approved dosing this child with FLUMIST.									Y	10/29/2007	10/29/2007	0		PVT	PVT	Concomitant Drug(s) Not Reported	Egg allergy	NI		MEDI0006125	1						1	Inappropriate schedule of drug administration; Medication error; No adverse reaction	FLUN3~MEDIMMUNE VACCINES, INC.~500490P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0297993	11/28/2007	CA	77.0	77		F	11/28/2007	Developed Zoster outbreak one week after receiving Zoster vaccine.  Started on antiviral									U	11/08/2007	11/15/2007	7		MIL	MIL	Albutero, Advair, Aspirin, Aciphex, Zocor, Fosamax, Losartin	None	Sulfa			1						1	Herpes zoster	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~GM~INFLUENZA (SEASONAL) (FLUARIX)~1|VARZOS~MERCK & CO. INC.~1088U~1~IM~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0297994	11/28/2007	NY	25.0	25		F	11/28/2007	Flu and pneumovax administered in right deltoid on 11/21/2007. On 11/23/07 complained of tenderness and reddness at the injection site extending toward the elbow.									Y	11/21/2007	11/23/2007	2		PVT	PVT	Singulair and Albuterol	none				1						1	Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~u2462aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1126u~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~c2889aa~5~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0297995	11/28/2007	PA	34.0	34		F	11/28/2007	Shooting pains from injection site distally with numbness in fingertips.  Stiffness in digits and elbow/wrist.  Pain is not constant, but comes and goes in waves every 2-3 minutes.  Patient describes the pain as a burning sensation.  Rated the pain a 10/10 when active, 5/10 when inactive.				Y					U	11/28/2007	11/28/2007	0		MIL	MIL	BCP-Orthotricycline	NONE	NONE			1						1	Burning sensation; Hypoaesthesia; Injection site pain; Joint stiffness	ANTH~EMERGENT BIOSOLUTIONS~FAV158~3~SC~LA~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500484P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0297996	11/28/2007	NY	56.0	56		M	11/28/2007	Patient received influenza vaccination on 11/26/2007 between 9-10am; patient has received the influenza vaccine for the past several years. At 1pm she began to experience puritis of the neck and edema of the eyelids. Difficulty with breathing and swelling of the tongue denied. Patient called her PCP for appointment but was unable to contact him and went home. Patient reports that this reaction had happen to her approximately 2 months ago when she had began a new medication (change from Avandament to Metformin) but the symptoms were worse. By 5pm the rest of her face began to swell and she had blisters on her eyelids and below her eyes; still no airway involvement. Patient denies any redness or swelling at site of injection. Patient saw her PCP 11/27/2207, at which time her symptoms had begun to subside. They did not perform any lab work or provide any treatment other than to instruct her not to ever receive the Influenza vaccine again. Patient is back to work today and states her symptoms are almost totaly resolved, with only mild puritis noted.				Y					Y	11/26/2007	11/26/2007	0	None	UNK	UNK	Acupril, Avandament, Atenolol, Glyburide, Zetia	None.	HTN, DM Type II			1						1	Blister; Eyelid oedema; No reaction on previous exposure to drug; Pruritus; Swelling face	FLU3~SANOFI PASTEUR~U2449AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298004	11/28/2007	NY	3.0	3		F	11/28/2007	Received phone call from mother ~32hrs after flu shot.  Patient had been fussy all day, and arm and shoulder had become bright red and hard, temps 100 to 100.1, got Tylenol all day. No streaking.  Had mother mark edge of erythema.  Following day, patient was much more comfortable, erythema had regressed overnight.									Y	11/26/2007	11/27/2007	1	none	PVT	PVT	none	no	Amoxicillin allergy---severe rash without respiratory difficulty; has tolerated cephalosporins			1						1	Body temperature increased; Injection site erythema; Injection site induration; Irritability	FLU3~SANOFI PASTEUR~U2494AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298005	11/28/2007	CA	38.0	38		F	11/28/2007	She had injection approx 9 AM and within 2 hours started to have cough/SOB. She took Benadryl 50mg. Then about 2 hours later her eyes started to swell and her neck was getting red. She went to the ED later that afternoon and was told to continue the Benadryl 50mg for 2 more days and was discharged, condition inproved, without further incident.				Y					Y	10/10/2007	10/10/2007	0	None	PVT	PVT	none	none	none			1						1	Cough; Dyspnoea; Erythema; Eye swelling	FLU3~SANOFI PASTEUR~U2498AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298008	11/28/2007	NY	9.0	9		F	11/28/2007	Child began vomitting after the administration of the vaccines, complained of burning in her mouth, then swelling of her lips, then swelling of her face. There was no respiratory or cardiovascular compromise - 0.3ml of Epinephrine was administered and child diagnosed as having an anaphlylactic reaction and was transferred from the outpatient department to the Emergency Department.  There child developed total body redness, itching and swelling and was treated with Benadryl, corticosteroids, H2 blockers and hospitalized for observation. 12/10/07-records received for DOS 11/28-11/29/07-DC DX: anaphylactic reaction. Oral swelling, hives to face. Vomited. Admitted for observation.				Y	Y	1			Y	11/28/2007	11/28/2007	0		UNK	UNK	None	None	Overweight			1						1	Anaphylactic reaction; Erythema; Lip swelling; Oral discomfort; Pruritus; Swelling; Swelling face; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80070~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARCEL~MERCK & CO. INC.~1513U~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0298012	11/28/2007	TX	37.0	37		M	11/28/2007	EMPLOYEE REPORTED FEELING CHEST PAIN, RESTLESSNESS, PALPITATIONS AND HE SHOWED CONSISTENT DRY COUGH AT 11:55 AM. NO HIVES,WHEEZING, REDNESS SHORTNESS OF BREATH OR SWELLING OF THE FACE WERE NOTED.HIS INITIAL VITAL SIGNS BEFORE THE VACCINE WERE B/P 138/90, PULSE 76, T-96.8F,R-20. VITAL SIGNS AFTER THE ADVERSE REACTION WERE @11:55AM BP 150/100, P-107, T-99.1F,R-18. MEDICAL DIRECTOR, NOTIFIED ABOUT THE REACTION VIA PHONE AND SUGGESTED TO CALL EMS. EMS WAS CALLED @ 11:59AM.VITAL SIGNS @12:00PM WERE BP-165/109, P-126, T-99.6,R-18. EMPLOYEE PLACED ON OXYGEN VIA NASAL CANNULA @ 5L/MIN.EMS PUMPER 12 AND RESCUE 12 ARRIVED @ THE SCENE MONITORING THE OXYGEN SATURATION BEING 98%, AND THE BLOOD GLUCOSE LEVEL BEING @137 MG/DL. VITAL SIGNS @12:05PM BP-148/84, P-156,R-18. EMPLOYEE WAS TRANSPORTED TO THE HOSPITAL VIA STRETCHER BY EMS @12:06PM.  EMPLOYEE CONTACTED AT HIS CELL PHONE VERBALIZING THAT THE DOCTOR FROM THE HOSPITAL DIAGNOSED HIM WITH AN ALLERGIC REACTION TO INFLUENZA VACCINE. HE STATED THAT HE WAS DISCHARGED @ 3:30PM UNDER STABLE CONDITION FROM THE EMERGENCY ROOM,AND THAT THE DOCTOR TOLD HIM TO BE BACK TO WORK UNTLI 11/30/07.   12/7/07 Reviewed ER medical records which reveal patient transported by EMS 11/28/07 after experienced anxiety, sore throat w/swelling, nonproductive cough, red facial rash & mild SOB immediately s/p flu vax.  Tx w/IV benadryl, O2 & steroids.  Improved & d/c to home FINAL DX: acute allergic reaction.			Y	Y					Y	11/28/2007	11/28/2007	0	OXYGEN SAT 98% AND BLOOD GLUCOSE 137MG/DL BY EMS	UNK	UNK	N/A	N/A	N/A	N/A~ ()~~0.00~In Patient		1						1	Blood glucose increased; Blood pressure increased; Body temperature increased; Chest pain; Heart rate increased; Oxygen saturation normal; Oxygen supplementation; Palpitations; Restlessness	FLU3~CSL LIMITED~00149111A~2~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|HEP~MERCK & CO. INC.~0570U~3~IM~RA~HEP B (RECOMBIVAX HB)~1	USA	Life Threatening	Influenza
0298019	11/28/2007	TX	74.0	74		F	11/28/2007	This case was reported by the son of a consumer and described the occurrence of reduced range of motion in a 74-year-old female subject who was vaccinated with flu vaccine unspecified, manufacturer known to be GlaxoSmithKline. A physician or other health care professional has not verified this report. On 27 October 2007 at 10:30 the subject received unspecified dose of flu vaccine in the right arm. The injection was reportedly given high on the arm at the point where the humorous meets the joint. On 30 October 2007, in the morning, 3 days after vaccination with flu vaccine, the subject experienced injection site pain and pain and swelling in her right arm. As a result, she developed a reduced range of motion in her right arm. At the time of reporting the events were unresolved.								Y	N	10/27/2007	10/30/2007	3	UNK	PUB	PUB		Unknown	The subject has previously received flu shots with no problems documented. No problems documented following previous vaccinations in general.		A0696381A	1						1	Injection site pain; Injection site swelling; Joint range of motion decreased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Disabling	Influenza
0298020	11/28/2007	WI	81.0	81		F	11/18/2007	After Flu shot, I became ill that afternoon 10/23/07 - I stayed in bed for 4 days and rested then went to hospital - On 10/30 visited doctor who put me on steroids. On 11/1 saw another doctor who put me on antihistamine. I was in bed for about 3 weeks. Follow-up: I do not wish to release my medical records, as this flu - shot was my fault. I was ill at the time I took it.				Y	Y	1			Y	10/23/2007	10/23/2007	0		PUB	UNK		None				1						1	Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0298022	11/28/2007	OH	54.0	54		F	11/26/2007	Patient complained of pain and swelling left arm, shoulder, neck.  Seen by PMD and treated with anti-inflammatory meds.  Nerve relaxers and pain meds for inflamed muscle and nerve ending exposure per patient.									U	11/15/2007	11/16/2007	1		OTH	OTH		None known	Codeine, morphine			1						1	Inflammation; Local swelling; Musculoskeletal pain; Neck pain; Neuralgia; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2531AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~09896~UNK~IM~~PNEUMO (PNEUMOVAX)~1|TD~MASS. PUB HLTH BIOL LAB~Td193~UNK~IM~~TD ADSORBED (TDVAX)~1	USA		Influenza
0298024	11/28/2007	OR	49.0	49		F	11/28/2007	Immediate erythema surrounding injection site. Itching (mild) in area within a few minutes									Y	11/28/2007	11/28/2007	0	None	PUB	PVT		hepatic cirrhosis				1						1	Immediate post-injection reaction; Injection site erythema; Pruritus	FLU3~SANOFI PASTEUR~U2497AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298026	11/28/2007	CA	13.0	13		F	11/28/2007	Redness and swelling to right outer arm.									Y	11/26/2007	11/27/2007	1		PUB	OTH	None	Acne to face	None			1						1	Erythema; Oedema peripheral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA319AA~2~~~INFLUENZA (SEASONAL) (FLUARIX)~1|HPV4~MERCK & CO. INC.~1447F~1~~~HPV (GARDASIL)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B009AA~1~IM~~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1357U~2~~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0298027	11/28/2007	MA	5.0	5		F	11/28/2007	Developed red area of induration, tenderness, pain and itching at site of vaccination on left arm. Area 2x3 in deg.				Y						11/27/2007	11/28/2007	1		PVT	PUB		None	NKDA			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site pruritus	DTAP~SANOFI PASTEUR~U1986AA~5~UN~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2516AA~4~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0240~4~UN~LA~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0298029	11/28/2007	NC	57.0	57		F	11/28/2007	11 hours after receiving vaccine, pt reported a scratchy sensation in her throat with sensation of throat closing. Within 5 hours all her symptoms resolved without intervention. She noted no hives/wheezing/angioedema.									Y	10/18/2007	10/19/2007	1		PVT	PVT		None				1						1	Throat irritation; Throat tightness	FLU3~SANOFI PASTEUR~U2498AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298031	11/28/2007	CA	4.0	4		F	11/28/2007	Bell's palsy (R) side. 1/30/07-records received for DOS 11/23-11/30/07-C/O cough/congestion. Had dental appointment on 11/21/07 noticed face was not moving porperly. Left side Bell's Palsy. 11/30/07-face some improvement.									N	11/16/2007	11/20/2007	4	None	PVT	PVT	None	None	None			1						1	Facial palsy	FLU3~SANOFI PASTEUR~U2480FA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298033	11/28/2007	TX	24.0	24		M	11/27/2007	Two day following administration of the Flumist, soldier developed pharyngitis, sinusitis.  Tx'd by another provider for bacterial sinusitis which soldier reports decrease ssx but still loses his voice if he has to shout at his troops c/o S/T in a.m.									N	10/29/2007	10/31/2007	2		MIL	MIL						1						1	Aphonia; Bacterial infection; Pharyngitis; Pharyngolaryngeal pain; Sinusitis	FLUN3~MEDIMMUNE VACCINES, INC.~50048UP~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0298035	11/28/2007	MO	16.0	16		F	11/14/2007	itching-since injection urticaria				Y					U	11/07/2007	11/07/2007	0		PVT	PVT		URI	Amoxicillin-Hives			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2502AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AhAVB0UAA~1~UN~LA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~1062U~1~UN~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~4242AA~1~UN~RL~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0298036	11/28/2007	MA	0.3	0	.3	M	11/19/2007	Pt inadvertantly given flu vaccine at age 4 mos instead of 6 months. No problems upon leaving clinic-CDC notified. Baby's mother notified.										11/19/2007				PVT	PUB						1						1	Inappropriate schedule of drug administration; Medication error	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~DTAP + HEPB + IPV (PEDIARIX)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~UNK~UN~UN~HIB (NO BRAND NAME)~1|PNC~PFIZER\WYETH~~UNK~UN~UN~PNEUMO (PREVNAR)~1	USA		Influenza
0298037	11/28/2007	MA	31.0	31		F	11/13/2007	Fever, chills, rigors, T > 102 developed 2 days after vaccination, then neutropenia down to WBC = 1.3 and absolute neutrophil count 500 by 11/08/07, AST = 265; ALT = 106.  12/11/07 Reviewed hospital medical records which reveal patient experienced fever of unknown origin intermittently x 3 weeks of 102-103 with sweats & chills, HA, sinus congestion, sore throat, semi-productive cough, malaise, swollen tender submandibular lymph glands, fatigue & arthralgia when febrile. Seen by pcp multiple times & had ID & hematology outpatient consults prior to admission.  Admitted 11/8-11/13/2007 for antibiotic & further eval .  ID, heme & rheumatology consults obtained while hospitalized.  Tx w/IV antibiotics.  Fever gradually resolved. FINAL DX: pancytopenia, possibly related to underlying viral illness or autoimmune disorder; Fever of unknown origin, possibly related to viral syndrome, collagen vascular disease or reaction to flu vaccine.					Y	5			Y	10/11/2007	10/14/2007	3	11/09/07: WBC = 1.2; Platelets 108; ANC = 500; AST = 265; ALT = 106; Bone marrow: no leukemia; CT abd/pelusslonist WNL LABS: CT of abdomen/chest & sinuses were WNL.  CXR WNL. Bone marrow biopsy WNL.  ESR 70 (H).  Rheumatoid factor 27.9 (H).  ANA (+).  Echocardiogram was WNL w/o vegetation. WBC 1.2, H/H 11/22, platelets 104.	PVT	UNK		No	None PMH: sinusitis			1						1	Alanine aminotransferase increased; Aspartate aminotransferase increased; Biopsy bone marrow normal; Chills; Computerised tomogram normal; Neutropenia; Neutrophil count decreased; Pyrexia; White blood cell count decreased	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0298040	11/28/2007	UT	66.0	66		M	11/16/2007	Severe injection site reaction with inflammation and severe pain. Immunized 10/8/2007. Methylprednisone 4 mg dose pack 10/18/2007. Subacromial cortisteroid injection given on 10/28/2007.				Y					Y	10/08/2007	10/09/2007	1		OTH	PVT	Lorazepam, Kcl, HCTZ					1						1	Injection site inflammation; Injection site pain	FLU3~SANOFI PASTEUR~U2498AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298041	11/28/2007	PA	8.0	8		F	11/15/2007	PT given influenza vaccine on 11/12/07.  Second influenza vaccination given on 11/14/07 due to miscommunication between physician and nurse.									Y	11/14/2007	11/14/2007	0		PUB	PUB						1						1	Medication error	FLU3~SANOFI PASTEUR~V2502AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298042	11/28/2007	IA	63.0	63		F		Hives located on left thigh area over to left buttocks. Symptoms included an approximately 5 x 10  rectangular area of hives with persistent itching (red blotches and welts) for a period of three days; also itchy eyes with watery discharge during same three day period. Treatment included cold water packs, administering Calamine lotion to affected area and the taking of Advil tablets. Per follow up: Our office did not report a reaction.				Y					Y	10/23/2007	10/23/2007	0	N/A	PVT	UNK		None known	Sulfa			1						1	Eye discharge; Eye pruritus; Pruritus; Rash macular; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~08824~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0858U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~AFLUA315AA~UNK~UN~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0298043	11/28/2007	AZ	1.1	1	.1	F	11/14/2007	Fever and rash 12 days after vaccines. Viral exanthem vs vaccine reaction				Y					U	11/01/2007	11/13/2007	12	None	PVT	PUB	None	None	prematurity @ 30 WGA			1						1	Pyrexia; Rash; Vaccination complication; Viral rash	FLU3~SANOFI PASTEUR~VT2459NA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AH0032069A~1~UN~UN~HEP A (HAVRIX)~1|HIBV~MERCK & CO. INC.~04990~4~UN~UN~HIB (PEDVAXHIB)~1|MMRV~MERCK & CO. INC.~09110~1~UN~UN~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0298044	11/28/2007	MD	2.0	2	.9	M	11/20/2007	Fever of 102.2 degrees, nausea, vomiting, extremely swollen in the entire upper right arm. Required antibiotic and steroid, cream application				Y					Y	11/07/2007	11/08/2007	1		PVT	OTH	None	None	None			1						1	Nausea; Oedema peripheral; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0298045	11/28/2007	MA	56.0	56		F	11/20/2007	Dizziness for two days and explainable agitated mood - lasting for seven days.									Y	10/30/2007	10/30/2007	0	None	PVT	PVT						1						1	Agitation; Dizziness; Mood altered	FLUX~UNKNOWN MANUFACTURER~AFLUA280CA~2~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TTOX~GLAXOSMITHKLINE BIOLOGICALS~TD182~2~UN~LA~TETANUS TOXOID (TEVAX)~1	USA		Influenza
0298046	11/28/2007	GA	7.0	7		M	11/16/2007	Arm swollen and red, vesicle x 2 on arm.										11/14/2007	11/15/2007	1		PUB	PUB						1						1	Blister; Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~U2476HA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1120U~3~UN~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0298047	11/28/2007	ME	34.0	34		M		Local cellulitis (resolving), palpations, malaise, loss of appetite, fatigue.									Y	11/14/2007	11/15/2007	1		PVT	PVT		None	Decreased hearing, sciatica, pre-diabetes, hyperlipidemia			1						1	Anorexia; Cellulitis; Fatigue; Malaise; Palpitations	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81110~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~10846~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0298048	11/28/2007	MI	29.0			M	11/19/2007	-pt passed out in chair-5 minutes after shot -pt regained conscious after-mild shake and loud voice -pt explained later that he has done this at his last Dr visit -Transported to ER by paramedics				Y					Y				Blood pressure 119/62 pulse 57	OTH	PVT	UNK	None	None			1						1	Blood pressure; Immediate post-injection reaction; Loss of consciousness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA319AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0298049	11/28/2007	NV	1.07	1	.1	M	11/16/2007	Imms rec'd 11-13-07. Noted reaction 11-14/15-07 (Arthus). Treated with ice, antihistamine and pt f/u on 11-17-07.				Y					Y	11/13/2007	11/14/2007	1	None	PVT	PVT		None	None known	Arthus Rxn~Vaccine not specified (no brand name)~UN~1.00~Patient		1						1	Type III immune complex mediated reaction	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B062AA~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2456EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB359AA~3~IM~RL~HEP B (ENGERIX-B)~1|PNC~PFIZER\WYETH~C35168~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0298050	11/28/2007	NV	1.1	1	.1	M	10/16/2007	Imms rec'd 11-13-07. Noted reaction 11-14/15-07 (Arthus). Treated with ice, antihistamine and pt f/u on 11-17-07.									Y	11/13/2007	11/14/2007	1	None	PVT	PVT		None	None known	Arthus Rxn~Vaccine not specified (no brand name)~UN~1.00~In Patient		1						1	Type III immune complex mediated reaction	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B062AA~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2456EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB062AA~3~IM~RL~HEP B (ENGERIX-B)~1|PNC~PFIZER\WYETH~C35168~4~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0298051	11/28/2007	WI	54.0	54		F	11/20/2007	Localized cellulitis 2 days after influenza vaccine.  Red, hot to touch, four inch area on L deltoid.									Y	11/14/2007	11/15/2007	1	None	PVT	PVT	albuterol inhaler, buspirone, cyclobenzaprine, Nexium, primrose oil, flaxseed oil, Advair	None				1						1	Cellulitis; Erythema; Skin warm	FLU3~SANOFI PASTEUR~U2450AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298053	11/28/2007	OH	60.0	60		M	11/16/2007	High fever, pounding headaches, heart racing, weak, muscle aches, soreness to touch of skin. Lasted 1 week. Took - Tylenol extra strength for fever - Darvocet for pain.										11/09/2007	11/09/2007	0		PUB	OTH	Toprol XL; Anfranil; Amyerl; Plavix; Jaunivia; Tricor; Glucophage DR; Vytorin		Heart/diabetes			1						1	Asthenia; Headache; Myalgia; Pain; Pain of skin; Palpitations; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0298054	11/28/2007	GA	53.0	53		F	11/18/2007	Bruising, soreness and red spot at injection site day after immunization (Friday, Nov. 16th). On Saturday, Nov. 17th, red spot spread to 2 1/2 inches in diameter just below injection site.									U	11/15/2007	11/16/2007	1		OTH	PVT						1						1	Injection site bruising; Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~42506AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298055	11/28/2007	UT	22.0	22		M	11/15/2007	Cellulitis over deltoid				Y					U	11/13/2007	11/14/2007	1		PVT	UNK						1						1	Injection site cellulitis	FLU3~SANOFI PASTEUR~U2504AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB207BA~2~IM~LA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~0832U~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0298056	11/28/2007	CO	37.0	37		F	11/23/2007	Rash, breathing difficulty, asthma-like attack.									Y	11/20/2007	11/22/2007	2	None	UNK	PVT	None	None	None			1						1	Asthma; Dyspnoea; Rash	FLU3~SANOFI PASTEUR~U2454AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298057	11/28/2007	ND	1.71	1	.7	M	11/21/2007	None									Y	10/25/2007			N/A	PUB	PVT	N/A	N/A	N/A			1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79718~1~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0298058	11/28/2007	ND	2.0			F	11/21/2007	None									Y	10/25/2007				PUB	PVT						1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79718~2~UN~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0298059	11/28/2007	ND	1.7	1	.7	M	11/21/2007	N/A									Y	10/25/2007			N/A	PUB	PVT	N/A	N/A	N/A			1						1	No adverse reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79718~1~UN~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0298060	11/28/2007	ND	2.0	2	.9	M	11/21/2007	N/A									Y	10/25/2007			N/A	PUB	PVT	N/A	N/A	N/A			1						1	No adverse reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79718~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0298061	11/28/2007	ND	1.7	1	.7	M	11/21/2007	N/A									Y	10/25/2007			N/A	PUB	PVT	N/A	N/A	N/A			1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79718~UNK~~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0298070	11/28/2007	MD	5.0	5		U		Swelling tongue				Y					Y	11/19/2007	11/19/2007	0	None	PVT	PUB	PPD	None	Autism			1						1	Swollen tongue	FLU3~SANOFI PASTEUR~U2516AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0413U~2~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1331U~2~~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0298013	11/29/2007	GA	32.0	32		F	11/28/2007	Pain and swelling at injection site, body aches, headache, low fever (100 F), fatigue, chills, rash on both arms and on chest and on both sides of neck, swollen lymph nodes under arms and on sides of neck, itching all over body, sore throat, and mild chest pains directly over heart.  Also, patch of 'blood freckles' appeared on right shoulder--perhaps it is small rupture of blood vessels showing on the skin?  Not sure of medical term for 'blood freckles'. Received the vaccine approximately 8 hours ago.									N	11/28/2007	11/28/2007	0		UNK	PVT	Avalide 300/25mg once per day for hypertension		hypertension			1						1	Blood blister; Chest pain; Chills; Fatigue; Headache; Injection site pain; Injection site swelling; Lymphadenopathy; Pain; Pharyngolaryngeal pain; Pruritus generalised; Pyrexia; Rash; Skin discolouration	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0298014	11/29/2007		32.0	32		M	11/29/2007	PATIENT RECIEVED INMMUNIZATION AT GROUP FLU INJ SESSION. 50MINS AFER RECEIVING INJECTION AFTER BACK IN BARRACKS FELT SHORT OF BREATH, FAINT, AND HAD COUGH. PT DID NOT SEEK MEDICAL ATTENTION UNTIL 4 DAYS LATER WITH COMPLAINTS OF COUGH. GIVEN ALBUTEROL TX IN CLINIC AND INHALER. 2 DAYS AFTER TX PT STATED THAT THE FELT BETTER. NO HX OF ASTHMA.									Y	11/15/2007	11/15/2007	0	PA AND LATERAL CHEST XRAY: POSSIBLE ATELECTASIS,LUNGS HYPOINFLATED WITH CROWDING OF PULMONARY VASCULATURE	MIL	MIL	RECEIVED IPPD INTRADERMAL ON 9/22/07	NONE	PENICILLIN ALLERGY (ANAPHYLAXIS)			1						1	Atelectasis; Chest X-ray abnormal; Cough; Dizziness; Dyspnoea	FLUN3~MEDIMMUNE VACCINES, INC.~500485P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0298117	11/29/2007	SC	53.0	53		M	11/29/2007	Received influenza vaccination on 10/30/07.  On 11/3/07,1:30AM, awakeded with hives with itching on chest, arms and hands - not difficulty breathing.  Took OTC benadryl.  At 12 noon 11/3, no improvement. Went to private MD and was advised to take OTC antihistamines and Rx for steroid which was not used. That day also ate fresh cranberry relish (immediate allergic reaction when eats fresh fruit, applesauce, etc).				Y					Y	10/30/2007	11/03/2007	4	NONE	UNK	PUB	Multivitamins; Wellbutrin; Celexa; and Maxide	NONE	NONE		SC0721	1						1	Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80682~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0298146	11/29/2007	MD	48.0			F	11/29/2007	The patient wasa given the influenza vaccine in the left deltoid muscle upon admission.  The patient developed an inflammatory reaaction at the site.									Y					PVT	UNK	Avelox 400mg IV, Albuterol, Atrovent	lower lobe pneumonia	Bipolar depression			1						1	Injection site inflammation	FLU3~GLAXOSMITHKLINE BIOLOGICALS~anlua311ca~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0298147	11/29/2007	VA	43.0	43		M	11/29/2007	flu vaccine was administerd by Rn of L deltoid. No bleeding or redness occured at injection site immediately post injection. Approx 3 hours post injection  employee began experiencing pain of L upper arm. Pain moved to L elbow area the next day.Pain is only present when the arm is moving . No pain noted present when the arm is fully extended, or after arm is flexed . Arm hurts only on initial movement. Duration of symptoms, 37 days.Employee sought medical consult with Occupation health physician. Employee  referred to private physician for further evaluation and treatment of ongoing symptoms									N	10/29/2007	10/29/2007	0		UNK	UNK	No medications/ OTC nyquil afrin nasls spray for relief of symptoms of previous weeks' illness.	Undiagnosed Upper respiratory Illness symptoms x 1 week prior to vaccine. symptoms were resolved at the time of vaccine.	food allergies: strawberries, rasberries, animal allergies: cats, guinea pigs			1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U24655A~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298150	11/29/2007	OH	40.0	40		F	11/29/2007	Softball-sized area of redness and warmth around injection site									Y	11/26/2007	11/29/2007	3	N/A	PVT	PVT	Synthroid (DAW) 50 mcg po daily, Zetia 10 mg po daily	pharyngitis	hypercholesterolemia, hypothyroidism			1						1	Injection site erythema; Injection site swelling; Injection site warmth	DTAP~SANOFI PASTEUR~C2862AA~1~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2505AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298155	11/29/2007	MD	0.67	0	.7	M	11/29/2007	Hives - head/face, trunk, arms; facial swelling, redness; coughing/difficulty breathing within 30-50 min of vaccination; prior to physical symptoms (30 min after vaccination), infant was screaming with discomfort									Y	10/09/2007	10/09/2007	0		PVT	UNK			Suspected food allergies			1						1	Cough; Discomfort; Dyspnoea; Erythema; Screaming; Swelling face; Urticaria	FLU3~SANOFI PASTEUR~~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298156	11/29/2007	NJ	56.0	56		F	11/29/2007	Redness around the injection site about 14cm x 10cm.				Y					Y	11/27/2007	11/29/2007	2		PVT	UNK						1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U2501AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298157	11/29/2007	IN	27.0	27		F	11/29/2007	0915 felt knot in throat.  0958 informed RN of knot in throat, rash on neck. 1000 EMS called  arrived at 1005 am. Rash progress to face No sneezing,SOA, coughing, or itching as stated by patient. Taken by EMS to ED treated with antihistamine, steroids, and discharged around 1330.States no c/o at this time.				Y					Y	11/28/2007	11/28/2007	0	none	UNK	UNK	Kepra	None	epileptic.  Taking Kepra daily			1						1	Rash; Throat irritation	FLU3~SANOFI PASTEUR~U2511AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298158	11/29/2007	NJ	40.0	40		F	11/29/2007	On 11-4, 8 days after vaccine, pt noticed decreased sesation/numbness during bowel movement. The following day, pt noticed decreased sensation/numbness advanced to entire perineal area.  11-15 pt noticed numbness in posterior of right buttocks. On 11-16, pt called neurologists office and spoke with nurse. Told by drs. office to call back on Tuesday if not better.  On Tues. 11-19, pt called (the neurologist- see details in 19.) 11-21, pt noticed numbness in lateral aspect of right calf and bottom of heel. Symptoms have not progressed further since that date. 1/2/08-records received-DOS 11/29/07-on 11/2/07-middle two toes of right foot numb times 1 hour then on 11/14/07 noticed difference in sensation right buttock and loss of sensation right perineal area, difference in sensation had spread down right leg, right leg feels weaker, upper thigh. Right side of abdomen sensation is different. Feels urge to have bowel movement but feels does not have control during bowel movements. PE: Romberg negative. Intact thermal, intact vibratory. Impression: possible MS.									U	11/06/2007	11/14/2007	8	scheduled for brain and cervical MRI today, 11-29-07	UNK	UNK	Multivitamins	none	Went to neurologist 3 1/2 years ago for unexplained sensory numbness right lower quadrant of abdomen to lateral side of right hip and down anterior of right leg to 2 middle toes.  Has been asymptomatic since then. No diagnosis given. Other history of headaches.	none known~ ()~~0.00~In Patient|1 brother non known~ ()~~0.00~In Sibling		1						1	Hypoaesthesia	FLU3~SANOFI PASTEUR~U2475KA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298159	11/29/2007	CO	26.0	26		F	11/29/2007	I received a flu vaccination on 11.15.07. About 72 hours post vaccination, I noticed that the muscle pain in my deltoid did not resolve. It is now 11.29.07 and I am still having pain. It is difficult for me to put my shirt on and take it off, as well as pulling my left arm across my body. Last night, I had so much pain in my left arm (deltoid region) that I could not sleep. I took pain medicine, IB profen, and applied therogesic cream which helped the pain subside somewhat.									N	11/15/2007	11/19/2007	4		PUB	UNK	none	none	hypoglycemia, eating disorder, amoxycillen, ceclore, acetametaphine			1						1	Injected limb mobility decreased; Insomnia; Myalgia	FLUX~UNKNOWN MANUFACTURER~unknown~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0298161	11/29/2007	CO	39.0	39		F	11/29/2007	I recieved the vaccine at 4:30 pm on 11-23-07 in my left arm.  On 11-25-07 I woke up with a baseball size lump under in my armpit.  The lump was very tender and I was unable to use my arm or to move my arm without pain all day.  My lymph nodes were also swollen and very tender.  This condition has continued and as of this date I am still able to feel a lump in my armpit and I am unable to touch my armpit without pain.  My lymph nodes remain swollen and on 11-26-07 the lymph nodes in my neck were swollen and very tender to touch.  I have been taking tylenol but it does not help the pain.  I also have been taking benedryl to try to decrease the swelling.									U	11/23/2007	11/25/2007	2		UNK	UNK	Bentyl 40 mg TID; Tenormin 100mg HS	None	Irritable Bowl Syndrome; IHSS			1						1	Injected limb mobility decreased; Lymph node pain; Lymphadenopathy; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80822~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0298162	11/29/2007	MO	63.0	63		F	11/29/2007	On 10-14-2007 states she started feeling like she had the flu, achy all over, dizziness, diarrhea, felt clamy then hot, fatigue, stated she felt like her hips did not want to work. Stated that to her knowledge, her temperature was not over 98.8.  These symptoms still continue to present day.  Saw nurse practitioner, on 10-17-2007, 11-13-2007, 11-21-2007 and 11-28-2007.  On 11-21-2007 Labs were ordered and on 11-28-2007 was prescribed Zyrtec 10 mg. and Septra DS.				Y					U	10/12/2007	10/14/2007	2	On 11-21-2007 the following labs were performed full thyroid panel, CBC.	UNK	UNK	Celebrex,Lorazepam, Estradiol,Glucosamine/Condroitin, Bisacodyl,Multi-Vitamin, Vitamin C, Energy Action, Tylenol PM	No	Fibromyalgia			1						1	Cold sweat; Diarrhoea; Dizziness; Fatigue; Feeling hot; Full blood count; Gait disturbance; Influenza; Pain; Thyroid function test	FLU3~SANOFI PASTEUR~U2486AA~7+~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298167	11/29/2007	IL	7.0	7		F	11/29/2007	Patient received flu vaccine in thigh on Thursday,   11/8/07, around 3pm.  Friday afternoon, 11/9, he complained that his feet were itchy.  Saturday morning 11/10 he awoke with fever (101.6 F) headache, and HIVES all over his thighs, calves, ankles, and feet. We were out of town  called our pediatrician who advised giving him oral Benedryl and taking him to an acute care center.  We did so.  Patient responded to the Benedryl (hives began to fade) and Tylenol for headache and fever.  Felt bad for the day.  Hives faded in two days.				Y					Y	11/08/2007	11/10/2007	2	none	UNK	UNK	Adderall XR 15mg/day, Lexapro 5mg/day	none	none (autism spectrum disorder)			1						1	Headache; Pruritus; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U2528AA~5~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298188	11/29/2007	UT	8.0	8		F	11/21/2007	Right upper lobe of lung collapsed.  12/7/07 Reviewed hospital medical records which reveal patient experienced 2 week of perisstent nonproductive cough w/intermittent SOB, wheezing & sharp stabbing right neck pain beginning 1 week s/p vax.  Persistent RUL collapse & possible foreign body aspiration which was ruled out.  Admitted 11/14-11/18/2007.  Tx w/antibiotics, PPD & aggressive pulmonary toilet.  Pulmonary consult done.   FINAL DX: no d/c summary available, admit & d/c dates obtained from ROI.  Bronchoscopy revealed asthma w/RUL collapse.					Y	5			N	11/01/2007	11/03/2007	2	chest xrays x 5, Contrast chest CT, bronchoscopy LABS: CXR RUL collapse/consolidation.  Bronchoscopy done 11/15/07.  Viral respiratory panel (-).  CT scan of chest  RUL collapse.	PVT	PVT	None	None	chronic abdominal pain, no specific cause identified PMH: PE tubes in infancy.  urinary leakage. Family Hx: siblings w/allergies.  Parent w/pneumonia 1-1 1/2 mos prior to patient admit.			1						1	Bronchoscopy; Collapse of lung	FLUN3~MEDIMMUNE VACCINES, INC.~500490P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0298190	11/29/2007	NJ	46.0	46		F	11/02/2007	Had onset of angioedema throat swelling. seen and treated 2 times in ER. 10-16-07. Admitted 10-16-07 x 48 hr Readmitted x 1 to ER again 11-2-07.  12/11/07 Received hospital medical records of 11/2-11/3/2007 patient experienced recurrence of angioedema, tongue swelling, maculopapular rash & blistering of lips when steroids were tapered.  Tx w/IV steroids & admitted overnight for observation after switching to oral steroids. FINAL DX: Allergic reaction.  1/8/08 Received additional hospital medical records for 2 different admissions. 10/16-10/18/2007 patient experienced angioedema w/airway compromise & swelling of tongue & floor of mouth, trouble swallowing, speech difficulty & rash x 4 days.  Seen by pcp earlier on 10/16 & tx w/epi & benadryl.  Sent to ER, treated w/IV steroids & antibiotics & d/c to home.  Returned to ER later same day with same s/s & SOB & difficulty handling oral secretions. Admitted for observation.  Oral surgery consult done.  Laryngeal scoping done & was WNL as swelling resolved.  D/C to home on tapering steroids FINAL DX: angioedema w/airway compromise & swelling of tongue & floor of mouth.  10/19-10/28/2007  patient experienced progressibly worsening SOB, tongue swelling, perioral numbness & paretic erythematous macular papular rash on chest & back angioedema x 1 day.  Tx w/IV steroids, benadryl & admitted.  Exam revealed facial flushing & periorbital edema.  Improved & d/c to home on slow tapering steroids. FINAL DX: angioedema secondary to flu shot, resolved. Annual Follow-up Information 12-DEC-2008: Still residual pain and discomfort in joints. 60 Day Follow-up Information 30-JAN-2008: Still recovering from side effects. Steroid Tx for angioedema/significant myalgias.				Y	Y	5			N	10/12/2007	10/14/2007	2	all (-). LABS 10/16/07: WBC 11.4 (H), lymphs 11% (L), polys 77.7% (H), plts 439 (H).  Neck soft tissue x-ray revealed nasopharyngeal fullness/edema.  CT scan reported as negative. LABS 10/19/07: CXR WNL.  WBC 22.9 (H), plts 459 (H), lymphs 10% (L), polys 86 (H) LABS 11/2/07: WBC 18.2 (H), Chemistry WNL except glucose 144 (H).  CT of head done 11/11 WNL.  Allergy testing (-).	PVT	PVT	Synthroid, Allegra, Acidoten, Advil, Albuterol	None	Asthma, Hypothyroidism PMH: allergic reaction to flu shot 10/07.  GERD steroid induced.  Hypothyroidism.  Sleep apnea.  Steroid induced anxiety & hyperglycemia. Asthma exacerbations.  Allergy: pencillin, sulfa & flu shot.	Rash, Itch~Influenza (Seasonal) (no brand name)~UN~46.00~Patient		1						1	Angioedema; Arthralgia; Discomfort; Pharyngeal oedema; Swollen tongue	FLU3~SANOFI PASTEUR~U2469AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0298194	11/29/2007	AK	44.0	44		F	11/12/2007	Vesicular rash at injection site, started later same day, mildly painful. In for office visit 10/15/07 3 days later. Grouped dry vesicles. Did not improve with empiric acyclovir.				Y					Y	10/12/2007	10/12/2007	0	None	PVT	OTH	Pentasa; Levothyroxine; Amitriptyline; Nexium		Severe Crohn's Disease; Hypothyroid; Fibromyalgia			1						1	Injection site pain; Injection site rash; Injection site vesicles	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA026AA~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0298198	11/29/2007	TX	61.0	61		F	11/24/2007	10-24-07 - teeth cleaned - 2000 mg amoxicillin. 10-25-07 - Headache - fever - tired - weak - cough - temp 103.5. 10-26-07 Above plus hurt - chills - sweats - thrush lasts 10-14 days except cough which lasted about 30 days - no one catches it from me - exact same scenario last year. Amoxicillin 500mg - 3x - 20 days.				Y					Y	10/24/2007	10/25/2007	1	None	PUB	PVT	Digoxin; Toprol XL; Plavix; Imdur; Aspirin; Zocor; Clonazepam; Triam HCTZ; Prevacid; Diflucan; Advair 250; Advair 500; Albuterol; Calcium; Magnesium; Soy; Vitamin; Nauzene; Dan Active	None	Asthma - Osteoporosis; Cancer remission since 2001 - Heart attacks; Compromised immune system	Same~Influenza (Seasonal) (no brand name)~1~60.00~Patient		1						1	Asthenia; Body temperature increased; Candidiasis; Chills; Cough; Fatigue; Headache; Hyperhidrosis; Pyrexia; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U2446AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298200	11/29/2007	WA	77.0	77		M	11/23/2007	1 hour after Flu vaccine-felt cold, hands numb, next few days-fatigue, weakness, malaise, weak-weakness (especially proximal legs and arms).									N	10/31/2007	10/31/2007	0	CBC with diff ESR, CRP, TSH, Pro BNP, Dig level, INR, renal, LFTs.	PVT	PVT	A fib on anticoag	No				1						1	Asthenia; Blood thyroid stimulating hormone; Brain natriuretic peptide; C-reactive protein; Cardioactive drug level; Fatigue; Feeling cold; Full blood count; Hypoaesthesia; International normalised ratio; Liver function test; Malaise; Renal function test	FLU3~SANOFI PASTEUR~U2453AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298205	11/29/2007	CT	90.0	90		F	11/27/2007	Right arm swollen and painful starting 10 hours after vaccination. Cortisone injection given by MD, referred to rheumatologist. Fluid removed from both shoulders. Not rheumatoid arthritis, gout or lyme.				Y					N	10/16/2007	10/16/2007	0		PUB	UNK						1						1	Fluid retention; Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80435~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0298206	11/29/2007	CT	64.0	64		F	11/27/2007	45 minutes after vaccination, thought she had an almond stuck in her throat - drank copious amounts of water.  Restless, itchy eyes all night.  Woke up the next morning - eyes, lips and right side of throat swollen.  Benadryl x 24 hrs, no further flu shots (ate almonds with no problem since then).			Y	Y					Y	10/22/2007	10/22/2007	0		PUB	PVT		No	None Known			1						1	Eye pruritus; Eye swelling; Lip swelling; Pharyngeal oedema; Restlessness	FLU3~SANOFI PASTEUR~U2478BA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0298212	11/29/2007	NH	58.0	58		F	11/29/2007	After injection, pt had excessive bleeding immediately following along with a 4mm bump. After about 5 min, I noticed a red rash around the injection site. Pt was given 50mg of diphenhydramine.									Y	11/21/2007	11/21/2007	0	N/A	OTH	PVT		N/A				1						1	Injection site haemorrhage; Injection site mass; Injection site rash	FLU3~SANOFI PASTEUR~U2488AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298215	11/29/2007	NY	51.0	51		F	11/29/2007	Soreness in left arm. Pain traveled down left arm to left wrist and hand. Two days later after putting ice on left hand, my hand swelled up.				Y					U	10/19/2007	10/20/2007	1	None	PUB	PUB	None	None	None			1						1	Oedema peripheral; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0298235	11/30/2007	IN	2.0	2	.9	F	11/30/2007	Father noted red face x 4 days.  Low grade fever x 2 days. Runny nose.  Behavioral changes...more defiant and much more energetic.  Sleeping more and eating more than normal.									Y	11/26/2007	11/27/2007	1	none	PUB	PUB	none	none	none...father states healhty child			1						1	Abnormal behaviour; Erythema; Hypersomnia; Increased appetite; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500489P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0298282	11/30/2007	NY	38.0	38		F	11/30/2007	I received Influenza vaccine at work as recommended by employer at 1030 on 11/2/2007. Approx 1 hr after admin., I began to cough. As the course of the day progressed I became ill. At approx 5:00 pm I was at home and my throat and lungs felt as if they were closed I was unable to take a deep breath. Benadryl did not relieve symptoms. I went to ED at LMH and was given Epinephrine via breathing tx . My symptoms were immediately relieved. The ED had me stay for observation afterwards to ensure treatment.effects				Y					Y	11/02/2007				PVT	UNK	Adderal 7.5 mg po (am dose)Vitamin b6 zinc	none felt fine prior to shot	allergic: Vicodin, (horse serum ) Tetanus			1						1	Cough; Dyspnoea; Throat tightness	FLU3~SANOFI PASTEUR~u2462aa~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298284	11/30/2007	MI	1.42	1	.3	M	11/30/2007	Patient was to have received .25ml for flu vaccine and was given 0.5ml									Y	11/27/2007	11/27/2007	0	none	PVT	PVT	none	none	none			1						1	Incorrect dose administered; Medication error	FLU3~SANOFI PASTEUR~2509AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298288	11/30/2007	AL	35.0	35		F	11/30/2007	Patient had a an allergic reaction to the vaccine on the (R) upper arm which radiates down the entire arm.									Y	11/29/2007	11/29/2007	0		MIL	MIL		None.	PCN and Vicodin			1						1	Hypersensitivity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA063AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0298290	11/30/2007	GA	80.0	80		F	11/30/2007	The following morning the husband noted that patient was talking out of her head. By noon she could not stand under her weight because of weakness.  She has continued to waiver between orientation and disorientation.  This is her second hospital day.  It is not known when she will be discharged.  12/21/07 Reviewed hospital medical records which reveal patient experienced right arm pain, warmth & swelling with fever, chills, dry mouth, weakness, lightheadedness, decreased oral intake & acute confusion.  Seen at outlying ER 3 days prior to admit for syncope & d/c to home when CT scan head WNL.  Admitted 11/29-12/03/2007.  Exam also revealed submandibular lymphadenopathy & breast tenderness.  Right deltoid w/large area of erythema & tenderness.  Tx w/IVF & IV antibiotics.  Improved & d/c to home. FINAL DX: Presyncope, likely secondary to dehydration; right arm cellulitis; hypokalemia.				Y	Y	5			Y	11/26/2007	11/27/2007	1	LABS: WBC 5.2 (N).  Blood c/s neg. Potassium 3.2 (L). Cardiac enzymes WNL.	UNK	UNK	Synthroid 75, Celebrex 200, Lopressor 50, Enablex, Nexium 40, Prozac 40, xanax 0.5 hs, HCTZ 50.	None	hypertension,hypothyroid(euthyroid), Alzheimer's, depression, osteoarthritis. PMH: macular degeneration.  Allergic pencillin.			1						1	Asthenia; Disorientation; Weight bearing difficulty	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78478~6~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~09630~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~1088U~1~IM~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Hospitalisation	Influenza
0298291	11/30/2007	MI	0.6	0	.6	F	11/30/2007	Pt spiked temp of 101.3 and had seizure; was taken to ER				Y					Y	11/28/2007	11/29/2007	1		UNK	UNK	none	none	none			1						1	Body temperature increased; Convulsion	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~ac21b114ca~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2505AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1126f~2~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~b47300h~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0507u~3~IN~NS~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0298294	11/30/2007	MO	0.5	0	.5	F	11/30/2007	HIGH FEVER 103-106. NO PHYSICAL FINDINGS. FEVER STARTED A DAY AFTER THE SHOT WAS GIVEN									U	11/28/2007	11/29/2007	1	NONE	PVT	PUB						1						1	Pyrexia	FLU3~SANOFI PASTEUR~UT2474EA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298321	11/30/2007	CA	70.0			M	11/30/2007	Information has been received from a Registered Nurse concerning a male in his 70's who was vaccinated with Pneumovax 23. Concomitant therapy included warfarin sodium (Coumadin) and influenza virus vaccine (unspecified). Subsequently the patient experienced a swollen and red arm. The patient went to the ER twice and it was not known whether he was admitted into the hospital. The patient was treated with IV antibiotics. As of 07-NOV-2007, the patient had recovered. The nurse felt that this was an other important medical event. Additional information has been requested.									Y				Unknown	OTH	OTH	Coumadin		Unknown		WAES0711USA01761	1						1	Erythema; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0298323	11/30/2007	IA	1.4	1	.4	M	11/29/2007	Had flu vaccine 11/21/07 at 9:30am.  Around 12:30pm child wouldn't eat, seemed pale to parents, seemed listless.  Then started dry heaving and vomiting.  Fell asleep at 12:45pm, slept for a while, then mom woke him and gave Tylenol.  Since waking up seemed back to normal self & took sips of water which was kept down.				Y					Y	11/21/2007	11/21/2007	0	None	PVT	PVT	None	None known	None			1						1	Diet refusal; Listless; Pallor; Retching; Vomiting	FLU3~SANOFI PASTEUR~UT2459RA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298324	11/30/2007	WI	71.0	71		F	11/24/2007	Beginning Jan 07 fell and couldn't get up. Neighbors had to bodily pick me up. Could not control any part of my body, had walker and had to get a wheel chair couldn't walk or do anything. Seen doctor on Jan 10. Then seen him on Feb 7 and he threw me out of his office and said your got a walker and wheelchair use it, see your own physician. Hospital said I had neuropathy. My physician sent me to a neuro doctor. He did blood test and an EMG and told me I had a virus from my flu shot. April 2 2007 he sent me for intravenous some monoglobulin for one week every day. Had therapy for 3 months finally I am able to walk and I do have control of my body. He also said I had Guillain Barre a slight bit for a while. Thank God I am ok now.  1/8/07 Clinic medical records reviewed which reveal patient experienced difficulty climbing stairs, falls, weakness, tiredness, difficulty walking, numbness in lfingers & toes starting in 1/2007.  Her pain woke her at night.  Seen in Neuro clinic 3/6/07 & dx w/polyneuropathy.  Was already received home PT & had aide to assist w/ADLs.  Returned to clinic 3/28/07 for EMG/NCS & started tx w/IVIG for total of 4 doses.  Returned to clinic 5/14/07 able to ambulate w/cane but still had numbess of hands & feet. Returned to clinic 7/10/07 & continued to improve, using cane only when outside, paresthesias had resolved, no pain & had normal use of her hands.  Clinic records indicate flu shot given 11/2006, not 4/2007 as patient reported.  Shot record not available. FINAL DX: Guillain Barre syndrome, resolving.			Y	Y					Y	04/02/2007			LABS: EMG/NCS diffuse sensory-motor neuropathy of demyelinating neuropathy w/axonal component & superimposed right ulnar neuropathy at elbow.	PUB	PVT			PMH: back, neck & leg pain.  MRI of brain done 2005 revealed cortical atrophy & multi infarcts which had occured w/o symptoms.  MRI of c-spine showed multi level foraminal stenosis & degenerative facet changes.  Bilat CTS.  Rod placement in right ulnar due to joint changes.  Hypothyroidism.  Strong family hx of DM.  Former factory line assembler.			1						1	Asthenia; Gait disturbance; Guillain-Barre syndrome; Neuropathy; Viral infection; Walking aid user; Wheelchair user	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0298325	11/30/2007	SD	3.0	3		M	11/27/2007	Here for flu shot. See VAR; 1025- Flu shot given in left leg - laying on exam table-; 1027 sat up and was talking and crying to mom. Note face becoming pale and lips becoming pale. O2 placed nasal cannula at 1.5 liters - Called for help. O2 sats 94%-95% at 1 1/2 liter - HR - 70 - responded to pain and mom's voice - X 2 IV attempts unsuccessful on hands and X1 #24 jilco Left antecubital by RN - fluids bolus started by NS. Epi Jr given at 1032. 911 -called 1045. at this time sats 98-99% and heart rate 120, and crying and fighting with IV starts. 1050 ambulance personnel here - information given - and transferred to ER by ambulance - parent in attendance. Assisted dad to ran to go and meet wife and son in ER.: Addendum: History and events as above. Past history in May '07 of similar incident post - Hep A vaccine. Heart Rate went down very low (a 10 or so, very bradycardia): Color was just very pale, including buccal mucosa. Skin was cold and clammy. The eyes were closed. patient responsive to Mom's voice and pain stimuli with attempted I.V. insertions. After Epi Pen given and NSS started, color slowly returned to normal and EMT bought patient to ER where he was given Benadryl and Steroid. Vitals were stable and patient was transferred to Peds. Dx - Vasonagal reaction vs Anaphylactic Shock.   12/19/2007 MR received for ER visit 11/14/2007 who presented after a reaction to flu vaccine with the impression: Vasovagal reaction. Child received vaccine and became pale, hypotensive  and bradycardic with loss of consciousness.  Had previous rxn of hypotension to Hep A vax. EpiPen and IV fluids administered in PMD's office and transported. Child improved promptly with tx.  No local rxn.			Y	Y	Y	1			Y	11/14/2007	11/14/2007	0	Tryptase (blood drawn) result (4.4) (0.4 - 10.9) normal	PVT	PUB	-Epi PenJR - x1(0.15mg); - O2 - 0.9% Normal Saline IV solution	None	Had same reaction after 1st dose Hepatitis A. PMH: Prior reaction to Hep A vax. Mild viral cough, bothered by bright light.	5-7-07~Hep A (no brand name)~1~0.00~In Patient		1						1	Bradycardia; Cold sweat; Crying; Heart rate decreased; Oxygen supplementation; Pallor; Peripheral coldness; Syncope vasovagal; Tryptase	FLU3~SANOFI PASTEUR~U2510AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0298327	11/30/2007	AZ	39.0	39		F	11/26/2007	Pt got flu shot at outlying clinic 10/9/07. Presented to our facility 11/1/07 w/ lower extremity weakness and transferred to hospital - hospitalized there  and w/u was consistent with Guillain-Barre syndrome - treated w/ IVIG w/ improvement.  12/7/07 Reviewed ER medical records which reveal patient experienced ankle swelling & pain, bilateral LE weakness, difficulty walking & fever.   W/u for rheumatic fever & tx w/penicillin & high dose ASA w/o improvement.  Transferred to higher level of care for further w/u of systemic inflammatory process, felt to be unlikely GBS due to (+) DTRs. 12/7/07 Reviewed hospital medical records which reveal patient experienced bilateral leg pain.  Saw PCP, dx w/UTI & started antibiotics.  Leg pain worsened & developed SOB, warmth & bilateral LE edema, weakness & flat red rash over the next 10 days.  ER dx w/possible rheumatic fever.  Tx w/penicillin & ASA.  Had some imiprovement but when stopped ASA fever returned.  Continued w/tingling of bilateral LEs.  Returned to ER & transferred to higher level of care.  Admitted 11/1-11/8/2007.  Neuro consult obtained.  Tx w/IVIG x 5 days.  Improved & d/c to home. FINAL DX: Bilateral LE weakness, suspect Guillain-Barre syndrome; elevated transaminases; vitamin B12 deficiency; hyperlipidemia; elevated sed rate. CDC's CISA staff has reviewed VAERS 298327 and concluded it is not GBS. Follow-up Information 16-DEC-2008: By chart review, no persistent neuro symptoms. I do not see this patient personally. Follow-up Information 18-DEC-2007: Pt was seen for problem on 1/1/07 - symptoms started several days prior.			Y	Y	Y	7				10/09/2007			LABS in ER: ESR (H), CRP  84.1(H), (+) RST, ASO 491 (H), RA factor (-), throat c/s neg. LABS in hospital: CXR WNL.  Sed rate max 111.  CSF WBC 0, RBC 5, protein 54, glucose 49.  Blood & csf c/s neg.  MRI brain c/w demyelinating disease.  MRI LS spine revealed L1-L2 DDD.  Echocardiogram WNL.	PUB	PUB	None known	RST (+); treated 10/28 for strep throat with penicillin	None PMH: parental arthritis, CHF & HTN.  Patient's son w/JRA.  Uncle w/GBS.			1						1	Guillain-Barre syndrome; Muscular weakness	FLU3~SANOFI PASTEUR~U2454AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0298328	11/30/2007	VA	4.0	4		F	11/29/2007	Redness and induration Right upper arm. 01/02/2008 MR received for DOS 11/29-12/02/2007 with DX:  Cellulitis R upper arm.  Pt developed redness and itching morning after vax.  Txd with po abx by PCP however developed vessicles/blistering and presented to ER. Tx with IV abx with resolution.				Y	Y	3			Y	11/27/2007	11/28/2007	1	Labs and Diagnostics:  X-ray R humerus with no soft tissue changes, no subQ air or acute bone process.  Blood cultures (-).	PVT	PVT		Well Child	None. PMH: none.  NKDA.			1						1	Injection site erythema; Injection site induration	DTAP~SANOFI PASTEUR~C2765AA~UNK~IM~LA~DTAP (DAPTACEL)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81274~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB171AA~UNK~IM~RL~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~Z1009~UNK~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1325F~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1071U~UNK~SC~LA~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0298329	11/30/2007	NY	3.0	3		M	12/02/2007	2 1/2 year old male c/o swelling and redness with itching on day #2 (after flu shot) around injection site. No tenderness or other complaints. 10x8cm erythematous swelling and warm/itchy rash around left upper arm.									Y	11/28/2007	11/28/2007	0	N/A	PUB	PUB	None	None	Denied			1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Rash erythematous	FLU3~SANOFI PASTEUR~U2524AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298331	11/30/2007	WA	67.0	67		M	11/30/2007	Pt has red bumps around inject site and sore arm day after inject and is still having pain in arm for over 1 week.									U	11/23/2007	11/24/2007	1		OTH	PUB	unknown					1						1	Injection site rash; Pain in extremity; Rash erythematous	FLU3~SANOFI PASTEUR~U2515AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298333	11/30/2007	NM	59.0			F	11/30/2007	-found a lump in right deltoid -some redness and swelling occurred									Y					OTH	PVT		None	Hypertension			1						1	Injection site erythema; Injection site mass; Injection site swelling	FLU3~SANOFI PASTEUR~U2493AA~2~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298335	11/30/2007	MN	41.0	41		M	11/30/2007	Pain at site of injection.									Y	11/19/2007	11/20/2007	1	None	PVT	UNK			Allergies: Actos Gabapentin 1. Hypogonadism 2.Impotence 3. Myalgia 4. Neuropathy in diabetes 5. Diabetes Type II 6. Insomia 7. Vestibular neuronitis 8. Hyperlipidemia 9. Pain in limb			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U2445AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1382U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0298336	11/30/2007	WV	65.0	65		F	11/30/2007	Swelling, redness and warm to touch. Left upper arm. Ibuprofen 800mg TID and Benadryl 25mg PRN									Y	11/29/2007	11/29/2007	0	None	PVT	PVT	Vit B12	None	Lidocaine, Vicodin. Cardiovascular disease; hypothyroid			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2513AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~099U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0298338	11/30/2007	SC	15.0	15		F	11/21/2007	13 Nov developed numbness from buttocks to toes, muscle weakness made it hard to walk. Seen by ortho 19 Nov - EMG - mild distal peripheral neuropathy, delayed peroneal motor latencies, and variable peroneal F waves.  12/4/07 Reviewed vax records which confirm lot # as reported.  12/11/07 Reviewed neurologist medical records which reveal patient initially seen 11/29/07 after experienced sudden loss of feeling from waist down approx 2 wks prior.  Had gradually improved prior to visit but still had some numbness & pain in calves & was noted to walk w/a waddling limp.  Tx w/steroids.  Returned to neuro 12/3/07 continuing to improve FINAL DX: atypical Guillain Barre syndrome vs. transverse myelitis, improving.				Y					N	10/03/2007	11/13/2007	41	LABS: MRI of LS spine revealed spondylysis L4.  EMG revealed peripheral neuropathy.  MRI of T-spine revealed mild degenerative change at T4-5 & T5-6 levels.	PVT	PVT		None	None PMH: migraine			1						1	Electromyogram abnormal; Gait disturbance; Hypoaesthesia; Muscular weakness; Neuropathy peripheral; Peroneal nerve palsy	FLU3~SANOFI PASTEUR~U2446AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298339	11/30/2007	OH	68.0	68		F	11/25/2007	A few hours after vaccine administered, very sudden shooting pain in left arm & under arm (arm pit area), could not raise arm.  Later followed by diarrhea, vomiting, pain in abdomen, muscle spasms.  Following day - still painful & still nauseous.									N	11/24/2007	11/24/2007	0		OTH	PVT						1						1	Abdominal pain; Axillary pain; Diarrhoea; Injected limb mobility decreased; Muscle spasms; Nausea; Pain in extremity; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA319BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0061U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0298341	11/30/2007	VA	66.0	66		F	11/05/2007	Intense itching, hives, low grade fever 99.2 - 100.2				Y					N	10/22/2007	10/22/2007	0	N/A	UNK	UNK	Actonel RD Allergy injection	None	Grasses, trees, cats, dogs, mold, dust, ragweed, Novacine, babituates			1						1	Pruritus; Pyrexia; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78994~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0298344	11/30/2007	PA	1.0			F		Temperature of 103 F, very hot and cold. Had a seizure. Was given Motrin/Tylenol for 4 days. Went to the hospital. Was losing color and couldn't breathe. She was given oxygen.									Y	11/08/2006	11/09/2006	1	Couldn't find anything wrong with blood. No urinary tract infection - performed a catheter.	PVT	OTH	Pepcid	No illness - she was fine.	None			1						1	Blood test; Body temperature increased; Catheter placement; Convulsion; Dyspnoea; Feeling of body temperature change; Oxygen supplementation; Pallor; Urine analysis	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0298345	11/30/2007	WI	8.0	8		F	11/19/2007	LAIV on Thurs-am. Fri and Sat runny nose and congestion. Sat. evening 101.5 degrees fever and chills - Tylenol and Ibuprofen alternating. Sat. evening thru Sun. nite. sat evening backache and leg aches. Sun. stomach pain - no appetite, Fluids were pushed by mom, thru feverish days. Mon. a-m- fever broke appetite returned. Feels. better.									Y	11/15/2007	11/16/2007	1	None	PUB	PUB	None	None	None			1						1	Abdominal pain upper; Anorexia; Back pain; Chills; Nasal congestion; Pain in extremity; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500489P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0298347	11/30/2007	RI	6.0	6		F	11/19/2007	Swelling, itching, inflamed and hot to touch at upper arm where shot was given.  Emergency room doctor said it was a local allergic reaction or cellulitis and gave antibiotic for seven days.				Y					Y	11/07/2007	11/08/2007	1		PVT	OTH			None			1						1	Hypersensitivity; Injection site cellulitis; Injection site inflammation; Injection site pruritus; Injection site reaction; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2491AA~5~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298349	11/30/2007	CA	38.0	38		F	11/12/2007	0.5 Tdap to (L) deltoid - immed onset pain down arm, gradually worsening over 30 min. Radial nerve sx's (pain/weakness), paresthesias radial dorsal hand.									N	10/24/2007	10/24/2007	0	Neuro study pending	PVT	PVT		None	None			1						1	Immediate post-injection reaction; Neuralgia; Pain in extremity; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA313GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|TDAP~SANOFI PASTEUR~C2825AA~1~UN~LA~TDAP (ADACEL)~1	USA		Influenza
0298350	11/30/2007	CT	18.0			M	11/15/2007	localized silver dollar size-Tdap localized silver dollar size-Hep B light red macular rash Flu no induration									Y					PUB	UNK						1						1	Injection site rash; Rash macular	FLU3~SANOFI PASTEUR~U2435AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~UNKNOWN MANUFACTURER~~3~IM~LA~HEP B (NO BRAND NAME)~1|TDAP~UNKNOWN MANUFACTURER~~UNK~IM~LA~TDAP (NO BRAND NAME)~1	USA		Influenza
0298351	11/30/2007	LA	58.0	58		F	11/19/2007	Patient called clinic today after receiving Influenza vaccine on 11-07-07 saying that she had a non-raised rash under her arms, breasts, and around her waist area that was itching. She said that it comes and out on 11-10-07 and has been there since. She also reported that she had swollen lymph nodes under her arms. She was instructed to call her MD and report back to us the outcome.									Y	11/07/2007	11/10/2007	3		PUB	PUB	Humira, Methotrexate	No	Rheumatoid Arthritis		LA071107	1						1	Lymphadenopathy; Rash pruritic	FLU3~SANOFI PASTEUR~U2437AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298355	11/30/2007	WA	23.0	23		F	11/29/2007	Febrile, shaking chills, myalgias, local swelling and pain.										11/27/2007	11/27/2007	0	None	PUB	PUB		Acute sinusitis	Diabetes Type 1			1						1	Chills; Myalgia; Pain; Pyrexia; Swelling; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA067~2~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1382U~1~IM~UN~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2842AA~UNK~IM~UN~TDAP (ADACEL)~1	USA		Influenza
0298356	11/30/2007	CT	3.0	3		F	11/30/2007	10 1/2 cm x 12 1/2 cm red, hot area at injection site - non tender. Afebrile - no pain.									Y	11/26/2007	11/28/2007	2	None	PVT	OTH	None	No	Penicillin - rash 12/04		CT200720	1						1	Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U2531AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298357	11/30/2007	VA	49.0	49		F	11/26/2007	positive rash/hives, edema of lips, pruritis - severe; I used Benadryl from 11/14 till 11/26;  From 11/19 to 11/26 took Methlyprednisolone				Y					Y	11/14/2007	11/14/2007	0	NONE	MIL	OTH	NONE	NONE	NONE			1						1	Lip oedema; Oedema; Pruritus; Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~500484P~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0298358	11/30/2007	NJ	1.3	1	.3	M	11/26/2007	Fever (highest 103) red and tender on both upper arms. Treated with Tylenol, Benadryl.									Y	11/24/2007	11/25/2007	1	Urinalysis, Urine culture to R/O UTI as cause of fever.	PVT	PVT	None	None	None			1						1	Culture urine; Erythema; Pyrexia; Tenderness; Urine analysis	DTAP~SANOFI PASTEUR~C2760AA~4~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2474AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0377U~3~IM~RA~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~B08702K~4~IM~RA~PNEUMO (PREVNAR)~1	USA		Influenza
0298359	11/30/2007	PA	48.0	48		F	11/30/2007	Patient reported that she experienced short of breath within twenty minutes of receiving the influenza vaccine.				Y						11/12/2007	11/12/2007	0	CBC, CMP, and Echo were all normal.	UNK	UNK	None		Allergy: Sulfa, Bactrim	Anaphylactic~Vaccine not specified (no brand name)~1~24.00~In Patient		1						1	Dyspnoea; Echocardiogram normal; Full blood count normal; Laboratory test normal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA310BA~4~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0298361	11/30/2007	NC	49.0	49		F	11/30/2007	Patients (R) deltoid is swollen red - red area continues around to axilla. Fever to 101.7, aching occurred 12 hrs after immuniz assoc'd with hand swelling in deltoid R>L.									Y	11/27/2007	11/27/2007	0		PVT	UNK		None	Pen - hives			1						1	Erythema; Induration; Oedema peripheral; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2501AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~09904~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2769AA~UNK~UN~LA~TDAP (ADACEL)~1	USA		Influenza
0298362	11/30/2007	GA	9.0	9		F	11/30/2007	Patient came into office today c/o swelling, redness left deltoid area 6 cm x 6 cm area noted, warm to touch, red swollen, slightly raised.				Y					U	11/28/2007	11/29/2007	1	None	PVT	UNK		Upper Resp. Infect.	None			1						1	Erythema; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U2478BA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB163AB~1~IM~RA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1253U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0298364	11/30/2007	MI	0.7			U		T-102 fever seizure within 2 hrs after immunization.  Was treated at hospital ER.  Sepsis work up - blood culture, spinal tap.  CBC urinalysis all normal.									Y					OTH	UNK		Upper respiratory infection				1						1	Blood culture negative; Convulsion; Full blood count normal; Lumbar puncture; Pyrexia; Urine analysis normal; Body temperature increased; Convulsion	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B127AA~UNK~~~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U24566A~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1435F~UNK~~~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B54007E~UNK~~~PNEUMO (PREVNAR)~1|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B127AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~2|FLU3~SANOFI PASTEUR~UT2456BA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~MERCK & CO. INC.~1435F~3~IM~LL~HIB (PEDVAXHIB)~2|PNC~PFIZER\WYETH~B54007E~3~IM~RL~PNEUMO (PREVNAR)~2	USA		Influenza
0298365	11/30/2007	MN	51.0	51		F	11/30/2007	Complained of chest pain pressure and difficulty breathing starting at 8:00pm and lasting until 3:00 a.m. Took an aspirin ad sat in recliner until symptoms resolved.									Y	11/06/2007	11/06/2007	0		PUB	PVT		None	Eczema, Dust, Pollen; Keflex			1						1	Chest discomfort; Chest pain; Dyspnoea	FLU3~SANOFI PASTEUR~U2445AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298366	11/30/2007	IL	59.0	59		M	11/30/2007	Patient states evening after injection left arm became black and blue from elbow to shoulder. States he is on Coumadin, levels have been okay									Y	11/28/2007	11/28/2007	0		PUB	UNK						1						1	Anticoagulant therapy; Contusion	FLU3~SANOFI PASTEUR~U2478AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298367	11/30/2007	CA	5.0	5		F	11/27/2007	On morning of 11/27/07 pt awoke with c/o itching and pain to upper left arm. On inspection noted area to be red and swollen approx size of a silver dollar. At 1230pm site reassessed a measured 3x2 with increased swelling. Reported to Imm and then to Dr.										11/26/2007	11/27/2007	1	No tests or labwork-Instructions rec'd to give her Benadryl and Tylenol	MIL	UNK		mild cold	Asthma controlled w/Flovent Singulair and Zyrtec			1						1	Injection site erythema; Injection site pain; Injection site pruritus; Injection site swelling	FLU3~SANOFI PASTEUR~U25116AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298368	11/30/2007	IA	1.1	1	.1	F	11/30/2007	2 1/2 hours after flu vaccine developed temperature of 102, inconsolable, not her usual self.  Fever lasted till evening (9-10), then low grade 100-10 during the night.  No fever 24 hours later.  Gave Ibuprofen for fever reducer.									Y	11/29/2007	11/29/2007	0	N/A	PVT	PVT						1						1	Body temperature increased; Crying; Pyrexia	FLU3~SANOFI PASTEUR~UT24736A~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0377U~3~IM~~HIB + HEP B (COMVAX)~1|HEPA~MERCK & CO. INC.~125EU~1~IM~~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~0986U~1~~~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~~3~IM~~PNEUMO (PREVNAR)~1	USA		Influenza
0298384	11/30/2007	NC	2.0	2	.3	F	11/30/2007	Vomiting 1 hour prior injection - Temp 105				Y					Y	11/16/2007	11/16/2007	0		PVT	PUB		N/A	N/A			1						1	Body temperature increased; Vomiting	FLU3~SANOFI PASTEUR~U2508AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298385	11/30/2007	CA	3.0	3		F	11/30/2007	Noted 1 1/2 hours after LAVI given parent noted she was very lethargic and had high fever she fell asleep laying on the floor. They returned to the office - Pt had Temperature = 102.4, sinus tachycardia, HR greater than 160, mild lid edema esp lower lids. She seemed tired but was alert and appropriate to exam: Nerve exam normal.				Y					Y	11/29/2007	11/29/2007	0		PVT	UNK		Resolving URI	None			1						1	Eyelid oedema; Fatigue; Lethargy; Pyrexia; Sinus tachycardia	FLUN3~MEDIMMUNE VACCINES, INC.~500431P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0298298	12/01/2007	IN	29.0	29		F	12/01/2007	*may or may not be relevant to flu vaccine.:within 1 week of vaccine-severe headaches, nasal congestion, tired, within 4th week after vaccine:pain behind right ear, cold sore on outside left lower lip, 10/25/07-sudden numbness to left cheek, rt of mouth dropped causing drooling, no blinking from rt eye, rt side of face flattened, lt side of face swelled, visited er for fear of stroke, Dr diagnosed with Bells' Palsey after CAT Scan cleared, then requested to keep lubricating eye with lacri-lube at night, and prescribed steroids, and and antiviral medication with referral to nose ear throat speacialist, 10/26/07-front top of tongue tingly and numb, some foods taste different, trouble eating and drinking from a cup, need assistance drinking by using straw and holding lips closed aroung straw, MD appointment with ENT Specialist- gave me same advice as Dr, and lenghtened medicatin use for up to 2 weeks; also had audioaulogy testing for any loss of hearing, 10/27/07-words with b,f, or p are difficult to pronounce, vision now blurred to rt eye, must wear patch and keep lubricationg with artificial tears, worked this day causing emotinal distress because of peoples reactions to my face, symptoms have progressively gotten worse and more difficult, 10/28/07- rt nostril has drooped causing less airway, and more dificulty breathing when eating or drinking, 10/29/07-saw family physician for third opinion, and said to expect it to get worse, but the Bell's Palsey will reach it's peak depending on the person, then improve very slowly, may take a couple of weeks to several months at least, prescribed anitbiotic and pain med for uti and pain for headaches and right ear cramps, hearing to rt ear is extra sensitive to loud noises, or lound bong sounds (feels like a thick needle piercing throught my right ear causing so much pain my body trembles and i cry (:<)). 12/1/07- no change lots of ear pain and blurred vision on rt side. Advise Bell's Palsey is still an unknown disorder (not knowing the culprit that causes this, but have linked to possibly be cause by a virus)  12/4/07 Reviewed vax record from HD which provided Sanofi Lot# U2452A & corrected date of vax to 10/26/2007.  12/4/07 Reviewed ER medical records of 11/25/2007 which reveal patient experienced sudden onset right facial droop, left side numbness & HA x 1 day.  Tx w/antivirals & steroids. FINAL ER DX: Bell's Palsy. 12/7/07 Reviewed pcp medical record of 11/29/07 which reveal patient experienced facial numbness & HA since 11/25/07.  Also c/o dysuria.  Given additional antiviral & eye ointment & patch.  Already scheduled to see ENT.  FINAL DX: Bell's palsy, dysuria, UTI. 1/22/08 Reviewed ENT medical records which reveal patient initially seen 11/26/07. Dx right Bell's palsy.  Tx w/steroids/antiviral & eye protection. Returned 2/18/07 & experienced extreme sound sensitivity & gen discomfort worsening.  Facial weakness remained.  Returned 2/28/07 s/p MRI which revealed maxillary sinusitis.  Tx w/antibiotic.  Bell's palsy improved. FINAL DX: right Bell's palsy but w/increased right ear pain & sound sensitivity; maxillary sinusitis.				Y					U	10/26/2007	11/25/2007	30	Cat Scan - normal, audio testing - normal,	UNK	UNK	generic-wellbutrin sr150mg bid, loratidine 10mg qd, multivitamin, flonase spray 1 am.	seasonal allergies, seasonal depression	PMH: TMJ, insomnia, chondromalacia, migraines, neck/back pain, vertigo, otalgia, chronic allergic rhinitis/sinusitis, depression, GERD.  Allergy codiene.			1						1	Audiogram normal; Computerised tomogram normal; Drooling; Dysgeusia; Dyspnoea; Ear pain; Eating disorder; Emotional distress; Eyelid disorder; Facial palsy; Fatigue; Headache; Hyperacusis; Hypoaesthesia facial; Hypoaesthesia oral; Nasal congestion; Oral herpes; Paraesthesia oral; Speech disorder; Swelling face; Urinary tract infection; Vision blurred	FLU3~SANOFI PASTEUR~U2452A~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298302	12/02/2007	FL	54.0	54		F	12/02/2007	severe allergic reaction:  painful, itchy, runny eyes, nasal congestion, wheezing									Y	11/16/2007	11/16/2007	0		PUB	PVT	Altace					1						1	Hypersensitivity; Lacrimation increased; Nasal congestion; Pain; Pruritus; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0298303	12/02/2007	NY	1.33	1	.4	F	12/02/2007	High Fever.  Rash on face, neck, chest and back.  Abcess on groin area.  Split personality - between happy and miserable.  Required three visits to doctor and antibiotic treatment.				Y					Y	11/17/2007	11/21/2007	4		PVT	UNK	Zantac for GERD	none	GERD			1						1	Abscess; Histrionic personality disorder; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0298304	12/02/2007	TX	2.0			F	12/02/2007	She received the vaccine 11/30/07 @4:30pm. that evening she was sweaty/did not sleep well I gave her some motrin/very irritable in morning fever 101.6 by afternoon 104.2 fever w/vomiting. I contacted her pedi Dr. advised she should be okay. three hours later sysmptons gone??									Y					MIL	PVT		none	none	na~ ()~NULL~~In Patient		1						1	Hyperhidrosis; Insomnia; Irritability; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~487371~1~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0298306	12/02/2007	CA	8.0	8		M	12/02/2007	High fever (103.6), headache, stomach ache.									N	11/30/2007	12/02/2007	2		PVT	PVT	Nasonex, Pulmicort, Claritin	None	Asthma, frequent infections, previous meningitis at 5 days old.	High fever (106)~Measles + Mumps + Rubella (no brand name)~2~5.00~In Patient		1						1	Abdominal pain upper; Headache; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0298308	12/02/2007	TN	30.0	30		F	12/02/2007	Extreme soreness at and around vaccination site, upper arm feel hot to the touch and is red and hard. Fever elevated by 2 degrees, headache, and chills 24 hours after injection rec'd. Pain and redness became more pronounced 8 hours following injection. Treated with Ibuprophen and Tylenol for the past day, fever lowered when piggy-backed, but pain has not been reduced.									U	12/01/2007	12/01/2007	0		UNK	PVT	NuvaRing	N/A	Allergy to penicillin, Theodur			1						1	Chills; Headache; Injection site erythema; Injection site induration; Injection site pain; Injection site warmth; Pyrexia	FLUX~UNKNOWN MANUFACTURER~unknown~7+~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~unknown~1~IM~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0298309	12/02/2007	CA	40.0	40		F	12/02/2007	Immediately upon receiving the flu vaccine (and having my left ear irrigated) on 11/19/07, I immediately felt dizzy to the point where I had to lie in my physicians office for about an hour.  Upon going home I continued to experience dizziness and nausea. On 11/21/07 I called my doctor to inform her that I was still having dizziness and nausea symptoms.  The physician stated that it was probably due to the ear irrigation and that I should just take it easy and the dizziness and nausea would eventually go away.  On 11/24/07 I talked to a pharmacist who suggested that I take Dramamine and follow up with my physician.  On 11/26/07 I went back to my doctor and informed her that I was still having dizziness and nausea.  She stated that ther was nothing that she could do and I that just needed to wait it out and that it would go away and that I could continue to take Dramamine.  To date I continue to have dizziness and nausea.										11/19/2007	11/19/2007	0	No tests or laboratory work was given.	UNK	UNK	Birth Control pills.	None	Allergic to Codeine.			1						1	Dizziness; Ear irrigation; Immediate post-injection reaction; Nausea	FLUX~UNKNOWN MANUFACTURER~~1~SC~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0298311	12/02/2007	IN	29.0	29		F	12/02/2007	I went in for my Yearly. while I was there, I got my frist EVER flu shot.  I was fine when I went in. About 2 hours after getting it, i felt misserable!  I was achey, which I knew would happen.  So I gave it a few days.  I felt some what better, but when I was rubbing my head, Imoved my hand to me ear, and felt a bump behind it.  When I pushed on it, my entire ear started hurting.  The next day, I was really bad.  I was runnng a low fever, and was sneezing.  I took some meds, and laid down.  The next day, it was still bothering me. i went to my PCP on that monday. I found out i had a nasty inner ear infection, which i had only had one in about 3 years.  So he gave me some antis, and i went home.  I took them and the bump went away.  I felt ok till about a week ago.  this was a week after I finished my antis.  I felt around again and the bump was back!  It did go away, but last nite, i felt around becasue it was hurting, and found it yet again.  this time it was in front of my ear.  i have told my PCP i think its related to my shot but he turned his head away and ignored it.  ive been laughed at, and noone belives me!  I am healthy and have only had 1 infection in 3 years. this isnt me!!!									N	11/02/2007	11/02/2007	0	Inner ear infection	PVT	PUB	was given Zpac for infection	none	none	ear problems~Influenza (Seasonal) (no brand name)~UN~29.00~In Patient		1						1	Ear infection; Ear pain; Pain; Pyrexia; Sneezing	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0298473	12/03/2007	PR	68.0	68		M	12/03/2007	This case was reported by a physician to a sales representative and described the occurrence of an unspecified adverse event in a 68-year-old male subject who was vaccinated with Fluarix (GlaxoSmithKline). The subject's medical history, concurrent conditions, and concurrent medications were not reported. No other vaccines were reported to be administered on the date of receipt of Fluarix. On 16 November 2007 the subject received unspecified dose of Fluarix (unknown). The dose was recorded as the 1st dose of Fluarix, however, information regarding previous immunization with influenza virus vaccine was not provided. On 27 November 2007, 11 days after vaccination with Fluarix, the subject experienced an unspecified adverse event which required hospitalization, and product complaint. The reported adverse event was that a male subject was hospitalized and placed in an intensive care unit 11 days after vaccination with Fluarix. No specific adverse events were reported. The reporting physician is seeking a possible quality assurance issue with the vaccine as to the cause of the subject's hospitalization. The physician considered the events were disabling and life threatening as well as requiring hospitalization. At the time of reporting the events were unresolved. The physician considered the events were probably related to vaccination with Fluarix.			Y	Y	Y	0		Y	N	11/16/2007	11/27/2007	11	UNK	OTH	OTH		Unknown	The subject's medical history, concurrent conditions, and concurrent medications were not reported.		A0697023A	1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA282EA~1~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0298476	12/03/2007	VA	8.0	8		M	12/04/2007	Prevnar ordered, Pneumovax administered instead, with the flu shot - (R) deltoid 11/27/07.  12/7/07 Reviewed hospital medical records which reveal patient experienced significant swelling, pain, induration & redness of right arm w/fever x 2 days.  Initially had nausea & only injection site was involved but then spread to involve entire right arm.  Seen at urgent care & dx w/allergic reaction to vax.  Condition worsened & seen by PCP, started on antibiotics & instructed to go to hospital if worsened.  Continued to worsen & admitted 11/29-12/4/2007.  Surgery consult done.  To OR on 12/1/07 for abscess I/D & biopsy of deltoid fascia.  No d/c summary available, obtained admit/dc dates from ROI. FINAL DX: right arm cellulitis & abscess s/p immunization; I/D of abscess.				Y	Y	6			Y	11/27/2007	11/29/2007	2	Cellulitis with abscess, us soft tissue LABS: US of right deltoid c/w cellulitis.  CT of head was WNL.	PVT	PVT			DiGeorge Syndrome PMH: Spina bifida occulta.  Frequent infections w/pneumonia (15 times).  Ear surgery.  Migraines.			1						1	Abscess; Cellulitis; Inappropriate schedule of drug administration; Medication error; Wrong drug administered	FLU3~SANOFI PASTEUR~U2506AA~4~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~067UF~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0298477	12/03/2007	MN	45.0	45		M	11/28/2007	10/15 immunizations given, 1026 onset of symptoms, 11/4 admission to hospital, 11/9 discharged from hospital.  Dx probable Guillain Barre syndrome.  See attached for details.  Mr. Wallin is a 45-year-old gentleman who was just diagnosed with Guillain-Barre syndrome.  The patient's train of events includes getting the influenza vaccine and tetanus, TDAP on October 15, 2007.  Later that week, maybe about the 18th or 19th, that is Thursday, Friday or the weekend, had a diarrheal illness for two to three days, not bloody.  All members of the family also got the same diarrheal illness, including his wife, two kids who were ages 6 and 8.  The patient is not aware if his kids developed this diarrheal illness first.  The following week, the week of October 22nd, developed a fever, flu-like illness, with headaches for several days.  That same week developed a feeling of numbness in the tips of his hands and fingers, and started developing progressive weakness.  Had an episode of a rash in his shoulder with a bullet-like rash, approximately 2-3 cm in diameter, which resolved within 1 day.  The patient is not clear if he has had any recent tick bites.  Currently headaches have resolved, fevers have resolved.  The patient has progressive weakness of his lower extremities.  He is now unable to really ambulate without assistance.  He feels that his right side is slightly weaker than the left.  The patient did receive some Doxycycline and Prednisone beginning on November 2, Prednisone 20 mg a day, Doxycycline which he continued through Sunday after which he was admitted on November 4.  Childhood asthma, inguinal hernia repair, wrist fracture.  Tobacco use, but quit on admission.  Alcohol use - daily.  Married, two daughters.  There is some handyman type work.  Multiple sclerosis.  One family member who died of a cerebral aneurysm.  Mother has factor 5 Leiden.  No cough, shortness of breath.  No bowel movement since Sunday.  Vital signs - temperature 36.3, pulse 90, blood pressure 142/92.  Oxygen saturation of 98% on room air.  General - no distress.  HEENT exam - sclerae anicteric.  Mucous membranes are moist.  No thrush.  Cardiovascular exam - regular rate and rhythm, no murmurs or gallops.  Lungs are clear to auscultation, soft, nontender, nondistended.  Positive bowel sounds.  Extremities - no clubbing, cyanosis, or edema.  Neurologic examination - weak hip flexors, knee flexion, extension, dorsiflexion plantar flexion as well as toe flexion, extension, all probably less than 3/5.  Right arm with extension was probably 3/5, right 5/5 flexion and extension, gross sensation seems to be intact in the upper and lower extremities both with standing, with difficulty.  Reflexes are not found in Achilles, patella, brachioradialis or bicipital.  Skin examination - no rashes.  12/04/2007 VAERS report submitted with MR attached for DOS 11/4-9/2007 with Principal DX:  Polyneuropathy and probable Guillain-Barre Syndrome.  2' DX:  Tobacco abuse.  Hyperlipidemia.  ER record of 11/01/07 also received.  Pt seen for paresthsias and unsteadiness on his feet.  MD thought related to anxiety and D/C'd. Pt presented to ER on 11/4/07 with a 2 week hx of distal tingling and numbness beginning in the figertips which spread upward into the hand.  Pt began having weakness and difficulty walking with falls. Pt noted 1 day rash on shoulder.   Neuro consult 11/5/07. Some respiratory distress noted. Pt unable to ambulate w/o assistance at that time.  PE (+) for weakness in multiple muscle groups and absent reflexes (Achilles, patellar, brachioradialis, and bicipital).  Weakness R>L. DX: GBS. Txd with IVIG with dramatic improvement. D/C home with EMG and NCS to be done as an outpt PRN. F/U appt 11/16/07 with pt able to ambulate with only mild gait disturbance.				Y	Y	5			Y	10/15/2007	10/26/2007	11	Lumbar puncture performed on admission, white count of 1, total protein was elevated at 151, glucose was 85.  Lyme CSF screen pending.  White blood cell count 8.9, hemoglobin 16.4, platelets of 323.  Differential unremarkable.  West Nile serology pending.  CRP less than 0.5.  Lyme antibody screen from October 29 and November 5 negative to date.  Vitamin B12 level is 42, ANA screen is negative.  Chest x-ray negative.  Head CT unremarkable.  Impression, Guillan-Barre syndrome.  Possibility etiologies are numerous.  One could be influenza vaccine or tetanus booster vaccination.  Another could be his diarrheal illness which is associated with Campylobacter infection.  Another thing could be this febrile with other members of the family also had including his daughter, which may be related to diarrheal illness or another viral infection.  Other viral infections could include West Nile virus, CMV, Epstein-Barr virus, enteroviral infection.  Lyme disease seems low on the differential given the train of course of events.  Labs and Diagnostics:  LP with protein 151. CSF cx (-). CASF gram stain shows few monos and rare pmns, no bacteria.  CSF Lyme (-). Head CT (-).  Lyme antibody (-). ANA (-).	PVT	PVT	ASA 81 mg daily  -> MDI prn multivitamins	Diarrheal illness 10/18/07 ; Viral illness 10/23/07	Bee stings, asthma, hyperlipdemia, Factor and Leiden. PMH: childhood asthma, inguinal hernia, wrist fx.  Allergic to bee stings.			1						1	Antinuclear antibody negative; Areflexia; Asthenia; CSF protein increased; Chest X-ray normal; Diarrhoea; Gait disturbance; Guillain-Barre syndrome; Haemoglobin normal; Headache; Hypoaesthesia; Influenza like illness; Lumbar puncture; Platelet count normal; Pyrexia; Rash; Scan brain; Serology test; Sick relative	FLU3~SANOFI PASTEUR~U2487AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2842AA~UNK~UN~LA~TDAP (ADACEL)~1	USA	Hospitalisation	Influenza
0298481	12/03/2007	WA	1.0	0	1	M	12/03/2007	See chart note Hives-dw. <30 after F/U #2.										12/03/2007	12/03/2007	0		PVT	UNK		RAD	RAD			1						1	Urticaria	FLU3~SANOFI PASTEUR~U24B1EA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298482	12/03/2007	CA	0.7	0	.7	M	12/03/2007	Flu Mist given nasally to 8 mo old child									Y	11/29/2007	11/29/2007	0	None	PVT	PUB	None	None	None			1						1	Inappropriate schedule of drug administration; Medication error; Wrong drug administered	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC218090AA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500490P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HIBV~SANOFI PASTEUR~UE923AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B08666F~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0298483	12/03/2007	CA	0.5	0	.5	M	12/03/2007	Flu mist given nasally to 10 month old child									Y	07/29/2007	11/29/2007	123	None	PVT	PUB	None	None	None			1						1	Medication error; Wrong drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500490P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0298484	12/03/2007	IL	2.0	2	1	F		Hive like rash 3 days after influenza shot given.									Y	10/29/2007	10/31/2007	2	None	PVT	UNK	None	None	None			1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~U2499AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298486	12/03/2007	MO	23.0	23		F	11/27/2007	25 min after injection client complains of feeling throat swelling (on inspection throat was swollen) - difficulty swallowing.  Lungs clear by auscultation - no respiratory distress at that time.  Benadryl 50mg PO given - monitored - pt. recovered.									Y	11/27/2007	11/27/2007	0		PUB	PVT			receiving allergy shots - physician OK'd flu shot			1						1	Dysphagia; Pharyngeal oedema	FLU3~SANOFI PASTEUR~U2466AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298487	12/03/2007	IA	72.0	72		F	11/13/2007	Redness, swelling, itching, general malaise, shakiness.  Given Benadryl & ice packs to area. Red area 20cm x 16cm, warm to touch.				Y					Y	11/12/2007	11/12/2007	0	None	PVT	PVT		None				1						1	Erythema; Malaise; Pruritus; Skin warm; Swelling; Tremor	FLU3~SANOFI PASTEUR~U2516AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0298488	12/03/2007	MA	73.0	73		F	11/10/2007	Patient received vaccine at a public clinic.  After 3 days, developed complete ptosis right eyelid and moderate to severe ptosis left upper lid.  Referred to neurolgy for treatment of M.G. 1/14/08-records received 10/25/07-C/O right eye swelling questionable reaction from flu shot. PE: droopy right upper eyelid.				Y					N	10/13/2007	10/16/2007	3	Myasthenia gravis panel (positive) 1/14/08-records received-Labs: 11/2/07-striated muscle Ab titer positive. Acetylcholine receptor binding antibody 13.84. DX: Myasthenia gravis.	UNK	UNK	Boniva 150 mg		NKDA - Osteopenia			1						1	Eyelid ptosis; Myasthenia gravis	FLU3~SANOFI PASTEUR~U2496AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298491	12/03/2007	CA	36.0	36		M	11/29/2007	2 days after receiving Flu Mist, pt began to have itchy, red rash on lower legs and lower back.  Since then, rash is lighter, but still with itching.  On exam today, faint macular, papular, & in some places vesicular rash on lower legs, lower back, abd, chest, neck & head.  Also had HA chills & body aches which lasted 2 days.				Y					N	11/21/2007	11/23/2007	2		MIL	PUB	Percocet 5/325 prn pain, Celebrex 200mg BID, Ambien 10mg prn sleep	None	chronic pain after injury R ankle			1						1	Chills; Headache; Pain; Rash erythematous; Rash macular; Rash papular; Rash pruritic; Rash vesicular	FLUN3~MEDIMMUNE VACCINES, INC.~500497P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0298493	12/03/2007	MD	71.0	71		F	12/05/2007	Woozy, disoriented about 15 minutes after receiving flu vaccine Thermisol free 2mg 0.25 LD.  Felt drunk for 4 plus hours during ER visit.				Y					Y	11/20/2007	11/20/2007	0		PUB	PUB	unknown	none	unknown			1						1	Disorientation; Dizziness; Feeling drunk	FLU3~SANOFI PASTEUR~UT2456BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298494	12/03/2007	MI	28.0	28		M	12/03/2007	Nasal congestion, nasal swelling, fever, sore throat, coughing.				Y					Y	11/28/2007	11/29/2007	1	None	PVT	PVT	None	None	allergic to Benadryl, I contact solution, tape adhesive	nose swelling~Influenza (Seasonal) (no brand name)~UN~23.00~In Patient		1						1	Cough; Nasal congestion; Nasal oedema; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500497P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0298496	12/03/2007	ND	11.0	11		M	12/03/2007	Patient got Menactra, Tdap, influenza around 3:30 pm 11-15-07, 12 hours later 11-16-07 3am had high fever 102, nausea,and vomiting, unable to hold Tylenol down. To Emergency that am, got IV's, nausea medication.				Y					Y	11/15/2007	11/16/2007	1		UNK	UNK	Ritalin	none				1						1	Nausea; Pyrexia; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80433~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|MNQ~SANOFI PASTEUR~U2370BA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B018CA~6~IM~RA~TDAP (BOOSTRIX)~1	USA	Emergency room visit	Influenza
0298497	12/03/2007	PR	7.0	7		F	11/13/2007	The patient's mother referred that after vaccination her daughter had fever for 3 days, inflammation in the injection site (left arm), seizures and vomiting.				Y					Y	10/30/2007	10/30/2007	0		PUB	PUB		No.	Hermansky Pudlak		PR0712	1						1	Convulsion; Injection site inflammation; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2490AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0880F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0298498	12/03/2007	PR	2.0	2	.2	M	12/03/2007	Patient's mother referred that her son  presented fever, vomiting and inflammation in the injection-site. He received Tylenol and Pedialyte for 24 hours. He was seen by the pediatrician.				Y					Y	10/30/2007	10/30/2007	0	No.	PUB	PUB	No.	No.	Hermansky-Pudlak		PR0713	1						1	Injection site inflammation; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2490AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0880F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0298500	12/03/2007	OK	27.0	27		F	12/03/2007	Received Flumist, was unaware that she was 2 weeks pregnant at the time of administration.									U	11/08/2007			None	PUB	PUB		None				1						1	Drug exposure during pregnancy	FLUN3~MEDIMMUNE VACCINES, INC.~500490P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|PPV~MERCK & CO. INC.~0886F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0298502	12/03/2007	MI	41.0	41		F	12/03/2007	Fifteen minutes after injection client complained of generalized itching at injection site.  Denied respiratory distress of SOB.  Took benadryl.  Primary physician notified and client driven by co-worker to physician office.				Y					Y	11/15/2007	11/15/2007	0		UNK	PVT	None reported	Denies	Denies			1						1	Injection site pruritus	FLU3~SANOFI PASTEUR~U25229AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298503	12/03/2007	MO	57.0	57		F	12/03/2007	soreness at site of injection, headache,occasional shooting pains down right arm									Y	11/05/2007	11/05/2007	0	NA	UNK	PVT	benecar	none	hypertension			1						1	Headache; Injection site pain; Pain in extremity	FLU3~SANOFI PASTEUR~02488AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0963U~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0298505	12/03/2007	CT	44.0	44		F	12/03/2007	Hospital RN administered influenza vaccination Fluvirin o.5ml - states that she almost immediately developed hives which progressed, with pruritis - reported to Employee Health approx 1 hour later - escorted to Emergency Dept, received epinephrine, steroids, and pepcid - responded well, discharged several hours later to home.				Y					Y	11/30/2007	11/30/2007	0	none indicated	MIL	PVT	unknown	no - ill several weeks before vaccination, well at time of administration	Reports allergy to Hepatitis B Vaccine - severe systemic reaction in the past	states had severe reaction no details - administered as an adult~Hep B (no brand name)~1~~In Patient		1						1	Immediate post-injection reaction; Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79241~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0298507	12/03/2007	MA	62.0	61		M	12/03/2007	REDDENED SWOLLEN AREA ON RIGHT ARM AT SITE OF PNEUMO SHOT									Y	11/27/2007	11/28/2007	1		PUB	PUB	unknown	no	unknown			1						1	Injection site erythema; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLA062AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1229F~1~SC~RA~PNEUMO (PNEUMOVAX)~1|TD~UNKNOWN MANUFACTURER~Td-182(UMass)~UNK~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0298509	12/03/2007	MA	50.0	50		F	12/03/2007	VERY SORE RIGHT ARM, SWOLLEN LYMPH NODES UNDER RIGHT AXILLA, FEVER, CHILLS									Y	11/29/2007	11/30/2007	1		PUB	PUB	NO	NO	NO			1						1	Chills; Lymphadenopathy; Pain in extremity; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA062AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1132U~1~SC~RA~PNEUMO (PNEUMOVAX)~1|TD~UNKNOWN MANUFACTURER~Td-182(UMass)~UNK~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0298510	12/03/2007	MO	2.0	2	.1	M	12/03/2007	Parents report that shortly after leaving the Health Department where injection was given, a red ring formed around the injection site, the next day the child's whole leg turned red and child had red rash and temperature of 101.  Parents stated that they medicated child with Zyrtec (5 mg./5 ml) dose 1.5 ml, prescribed for them by the allergist to treat allergic reactions.									Y	11/16/2007	11/16/2007	0	None	PUB	PUB	Zyrtec (5 mg/5 ml) dose is 1.5 ml twice a day.	no	Allergy to oatmeal, corn meal, eggs, cats, dogs.			1						1	Body temperature increased; Injection site erythema; Injection site rash	FLU3~SANOFI PASTEUR~UT247EA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298511	12/03/2007	OR	38.0	38		F	12/03/2007	11/28/07[11:30AM] Sinus pressure/headache/aching throat within 1-hour of vaccine. Following morning 11/29/07 [6:30AM] severe sinus pressure, swollen face, throat pressure. [2:30PM] significant facial pain, symptoms of throat closing. [3:15PM] Dr. Visit to MD primary care physician - confirmed sinus infection and breathing difficulty; prescribed Arithromycin and Benedryl. Took 2 benedryl every 4 hours for remainder of day; took 2 Arithromycin. 11/30/07 [6:30AM] continued taking Benedryl every 4 hours for throat pressure; taking one Arithromycin for add'l 4 days.				Y					U	11/28/2007	11/28/2007	0		UNK	UNK	None	None	Seasonal allergies; penicillin; pork	Prior allergic reaction with sinus infection & anaphylactic shock that was attributed at the time to allergic reaction to Amoxic		1						1	Dyspnoea; Facial pain; Headache; Pharyngolaryngeal pain; Sinus headache; Sinusitis; Swelling face; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA061AA~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0298512	12/03/2007	TN	1.0	1	.0	F	12/03/2007	Surrounding erythema (about 5 cm in diameter) appreared very shortly after administration of either HiB or IPV in right thight.  Knot develop at site.  Pt had fever to 101 for 2 days.  Antibiotics were prescribed (Bactrim, then Clindamycin), but pt did not tolerate any doses of either.  The erythema resolved in 3 days, but the small knot, and tenderness at the site, remain.									U	11/29/2007	11/29/2007	0		PVT	PUB	Macrodantin		VUR, grade II			1						1	Injection site erythema; Injection site induration; Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~u2493aa~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~ahavb214aa~1~IM~LL~HEP A (HAVRIX)~1|HIBV~MERCK & CO. INC.~0677u~3~IM~RL~HIB (PEDVAXHIB)~1|IPV~SANOFI PASTEUR~a0273-2~3~IM~RL~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0298513	12/03/2007	LA	0.75	0	.8	F	12/03/2007	9 month 22D old female presents with c/o Rash for yest woke with rash all over yest AM, spread since.        Flu shot given Friday (11/30), AGE noted 1 wk ago(11/22), Due to have PE Tubes tomorrow. Also, poss. chemical exposure as former trailer had been bombed for insects months ago; family went in over this weekend and child was playing on floor.										11/30/2007	12/02/2007	2		PUB	PVT			Chronic Otitis Media			1						1	Exposure to chemical pollution; Rash generalised	FLU3~SANOFI PASTEUR~UT2473HA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298515	12/03/2007	GA	2.0	2	.9	F	12/03/2007	My Daughter received the shot on Tuesday 20 Nov. By Thursday 22 Nov late morning, she was throwing-up. Her symptoms lasted for approximately 5 hours. On 23 Nov, 24 hours after the onset of symptoms in my almost 3 year old daughter, my 45 year old sister, whom lives in my house-hold as well, became violently ill with vomiting, diarrhea chills, etc. On 24 Nov, 20 hours later, I became ill with the same symptoms and 2 hours after me, my wife became ill. My mother came into town that Thursday, 20 Nov, but never became ill. My stepson returned from his fathers on the Sunday, 25 Nov, and did not contract the illness. My 1 year old son was in the same room at the doctor's office when my 3 year old daughter received the Flu Mist inhaler. He threw-up on Thursday and acted ill as well as ran a temperature the same time my daughter did. But, he did not become more seriously ill until the evening of the 24th-25 of Nov. He threw-up several times during the same period that my wife and I became ill. He did not get diarrhea though. I am in the service and in very good health. I receive the flu shot every year and had had one 3-4 weeks prior to these illnesses. My wife is in good health and has not had the flu shot this year.  Interrogative; my stepson later received the Flu-Mist on 29 Nov. On 2 Dec, He became ill with the identical symptoms that my 3 year old displayed. They both vomited several times over a period of 4-5 hours.				Y					Y	11/20/2007	11/22/2007	2	Lab test returned negative results.	PVT	UNK	N/A	N/A	N/A			1						1	Laboratory test normal; Secondary transmission; Sick relative; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0298516	12/03/2007	GA	11.0	11		M	12/03/2007	My Stepson, who is in very good health, received the Flu Mist inhaler on 29 Nov. He became Violently ill with-in 24-30 hours of administration. I would not had given it a second thought except for what  had happen earlier in the week. That narrative follows.                                                 My Daughter received the shot on Tuesday 20 Nov. By Thursday 22 Nov late morning, she was throwing-up. Her symptoms lasted for approximately 5 hours. On 23 Nov, 24 hours after the onset of symptoms in my almost 3 year old daughter, my 45 year old sister, whom lives in my house-hold as well, became violently ill with vomiting, diarrhea chills, etc. On 24 Nov, 20 hours later, I became ill with the same symptoms and 2 hours after me, my wife became ill. My mother came into town that Thursday, 20 Nov, but never became ill. My stepson returned from his fathers on the Sunday, 25 Nov, and did not contract the illness. My 1 year old son was in the same room at the doctor's office when my 3 year old daughter received the Flu Mist inhaler. He threw-up on Thursday and acted ill as well as ran a temperature the same time my daughter did. But, he did not become more seriously ill until the evening of the 24th-25 of Nov. He threw-up several times during the same period that my wife and I became ill. He did not get diarrhea though. I am in the service and in very good health. I receive the flu shot every year and had had one 3-4 weeks prior to these illnesses. My wife is in good health and has not had the flu shot this year.									Y	11/29/2007	12/02/2007	3	N/A	PVT	UNK	Adderall	N/A	N/A			1						1	Secondary transmission; Sick relative; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0298517	12/03/2007	CA	0.5	0	.5	F	12/03/2007	VACCINE REACTION BOTH LEGS				Y					Y	11/27/2007	11/28/2007	1		PVT	PVT		FEVER,INJECTION SITE WITH SL ECHYMOSIS				1						1	Injection site haemorrhage; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B124AA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U72459FA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF207AA~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B54015D~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0298520	12/03/2007	NM	31.0	31		F	12/03/2007	5:00 PM C/O ITCHING TO  LEFT UPPER EXTREMITY AND TORSO,  SCANT RAISED PAPULES TO LEFT FOREARM AND WRIST 5:15 VS B/P 132/76,P 93,RR 20 BENEDRYL 25MG PO GIVEN FOR ITCHING. MONITORED IN MEDICAL OFFICE.5:45 PM CONTINUE TO C/O ITCHING WITH INCREASED IRRITATION SPREADING T/O TORSO, DR NOTIFIED, RECEIVED ORDERS TO REPEAT BENEDRYL AND GIVE UP 100MG PO PRN, GAVE 25MG MORE AT THIS TIME, CONTINUE TO MONITOR IN MEDICAL OFFICE. 6:20PM VS B/P 108/82, P 82, RR20  PATIENT STATES TO HAVE DECREASED IRRITATION AND LESS ITCHING AT THIS TIME, NOTABLE FOR DECREASED RAISED RASH TO LEFT FOREARM AND WRIST AREAS.									Y	12/03/2007	12/03/2007	0		UNK	UNK		N/A	N/A			1						1	Pruritus; Rash papular	FLU3~CSL LIMITED~00149111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0298522	12/03/2007	AR	53.0	53		F	11/26/2007	Woke up Feeling Bad - (But felt bad going to bed - took Benadryl for Throat swelling 50 mg Dose) AM Tongue/Face Swollen Badly and Neck Swollen Took Benadryl; Took more Benadryl; Wheezing Symptoms Duration 2 hours.									Y	11/12/2007	11/13/2007	1		PVT	PVT		Multiple Allergies	(No Known  Egg Allergy)			1						1	Local swelling; Malaise; Pharyngeal oedema; Swelling face; Swollen tongue; Wheezing	FLU3~SANOFI PASTEUR~U2438AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298523	12/03/2007	MT	64.0	64		M	11/27/2007	Redness, induration at injection site of (R) deltoid from pneumococcal vaccine. Redness around upper arm.				Y					Y	11/21/2007	11/22/2007	1	None	UNK	UNK		Unknown	Unknown			1						1	Erythema; Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~42499AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~02006~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0298524	12/03/2007	MI	4.0	4		M	11/16/2007	Temperature over 105F (even with having taken Tylenol to reduce any fever) - led to vomiting and a febrile seizure (which lasted no more than 10 minutes).  This all happened about 11 hours after the DTaP immunization.				Y					Y	10/29/2007	10/29/2007	0		PVT	OTH	None	None	None			1						1	Body temperature increased; Febrile convulsion; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC14B061AA~5~~~DTAP + HEPB + IPV (PEDIARIX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0298527	12/03/2007	CA	56.0	56		M	11/26/2007	24 to 48 hrs after vaccine sore throat, then felt like a cold (runny nose, congestion)									Y	11/16/2007	11/17/2007	1		PUB	PVT				Flu~Influenza (Seasonal) (no brand name)~UN~54.00~In Patient		1						1	Nasal congestion; Nasopharyngitis; Pharyngolaryngeal pain; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0298529	12/03/2007	MA	47.0	47		F	11/20/2007	11am-screened for flu shot-stated she was immune-compromised and on a lot of med. for rheumatoid arhtirits. Metronidazole, Prednisone-denies egg allergy. Flu shot given. 11:05-negative for problems 11:10 c/o tongue feeling weird and difficulty breathing BP 160/90 P-112 called fire depart-911.  11:05 Epinephrine 0.3 mg sc (R) deltoid adm. by nurse EMT's on site. Family notified. Pt responding and Transported to hospital				Y					Y	11/18/2007	11/18/2007	0	Pt was treated in ER returned home about 3 hrs later to follow up with her MD on a day or so	PUB	OTH		None	Allergies to-Ditropan, PCN, Med hx of asthma			1						1	Dyspnoea; Feeling abnormal; Tongue disorder	FLU3~SANOFI PASTEUR~U2516AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298530	12/03/2007	TN	5.0	5		F	11/09/2007	Redness and swelling to injection sites = cellulitis.  Treated with Omnicef.				Y					U	11/05/2007	11/05/2007	0		PVT	PVT	None	None	None			1						1	Cellulitis; Injection site erythema; Injection site swelling	DTAP~SANOFI PASTEUR~C2607AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2449AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0170~4~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0527U~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1118U~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0298532	12/03/2007	VA	6.0	6		M	11/28/2007	Local edema, erythema, and induration with bruising.  Had mild systemic symptoms that resolved in 2-3 days.  Onset of reaction within 6 hours.									Y	11/21/2007	11/21/2007	0		OTH	PUB		No	Augmentin allergy			1						1	Contusion; Erythema; Induration; Oedema	FLU3~SANOFI PASTEUR~U2461BA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298533	12/03/2007	FL	50.0	50		F	10/31/2007	Developed hives after receiving the flu vaccine.  Has hx of allergy to thimerosal, no allergy to egg/egg products.				Y					Y	10/17/2007	10/18/2007	1	skin allergy test	PVT	PVT	Singulair, Allegra, prednisone, Zyrtec, benazapril	None	allergic rhinitis, HTN, contact dermatitis			1						1	Skin test; Urticaria	FLU3~SANOFI PASTEUR~U2457HA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298534	12/03/2007	CA	6.0	6		F	11/28/2007	Abscess at site of vaccines. Pustular drainage 6 days after vaccine administration. Treated with drainage and Septra.				Y					Y	11/21/2007	11/27/2007	6	Culture pending	PVT	PVT		None				1						1	Culture; Injection site abscess; Injection site discharge	FLUN3~MEDIMMUNE VACCINES, INC.~500496P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~MERCK & CO. INC.~0304U~2~IM~LA~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~1360U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0298536	12/03/2007	CA	3.0	3		M	11/26/2007	Fx F.S com area of redness, induration upper left arm									Y	11/19/2007	11/20/2007	1	None	PVT	PVT	Anox.	bilateral otitis media	None			1						1	Erythema; Induration	FLU3~SANOFI PASTEUR~U2480FA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298537	12/03/2007	MI	0.22			M	11/26/2007	Flu mist given (not 24 mos old yet).  Instructions were to watch for any respiratory distress as well as flu symptoms.  On 11-8-07 (day after) mother stated child had runny nose and 2 diarrhea diapers.  No ther symptoms or fever.  11-9-07 doing fine.									Y	11/07/2007	11/08/2007	1		PVT	PVT	None	None	None			1						1	Diarrhoea; Rhinorrhoea; Wrong drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500497P~1~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0298538	12/03/2007	ID	21.0	21		F	11/28/2007	Reddened rash like area to (L) deltoid states a little itchy at site. Benadryl taken by pt 11/15/07. Spoke to pt 11-16-07 1430 and rash beginning to fade. 11-28-07 Resolved.									Y	11/13/2007	11/15/2007	2	None	PUB	OTH	None	None	None			1						1	Injection site erythema; Injection site pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA294BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0298539	12/03/2007	OH	17.0	17		F	11/26/2007	Seen in ED 2 days after vaccines.  Received w/ pruritic rash & joint achiness.  Dx'd with allergic reaction and given diphenhydramine & prednisone.				Y					Y	10/11/2007	10/11/2007	0	None	PUB	PUB	albuterol, loratadine, Patanol eye drops	swollen eyelids, allergic rxn to eyeliner	no drug allergies, mild intermittent asthma	none known~ ()~~0.00~In Patient|none known~ ()~~0.00~In Sibling		1						1	Arthralgia; Hypersensitivity; Rash pruritic	FLU3~SANOFI PASTEUR~U2507AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2338AA~1~IM~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0298540	12/03/2007	MO	50.0	50		F	11/20/2007	Chest tightness and wheezing. Spouse informed writer this lasted approx 5-10 min and that sx slowly resolved over evening. At onset felt hot, flushed followed by chest tightness and wheezing per pt.									Y	11/19/2007	11/19/2007	0		PUB	PVT	Unknown	None	reported having multiple allergies	Severe~Smallpox (no brand name)~1~0.00~In Patient		1						1	Chest discomfort; Feeling hot; Flushing; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA026AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0297328	12/04/2007	FL	50.0	50		M	11/20/2007	19 days after administration of the flu vaccine, patient was seen at hospital with complaint of left facial numbness and paralysis and was diagnosed with Bell's Palsy.  He had a negative non contrast CT of the brain.  He was treated with conservative measures and acupuncture.  He has improved.				Y					U	10/11/2007	10/28/2007	17	Non contrast CT of the brain - negative.	PVT	UNK	Vitamin D 50,000 IU a week.  Mevacor 20 mg once daily	Dysphagia, GERD	NKDA.  No birth defects.  Allergic Rhinitis, Vitamin D deficiency, Hypercholesterolemia, fatty liver.			1						2	Facial pain; Facial palsy; Pyrexia; Viral infection; Facial palsy; Hypoaesthesia facial; Scan brain	FLU3~SANOFI PASTEUR~49281-380-15~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2462AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0298655	12/04/2007	NY		0	.0	U	12/04/2007	This case was reported by a pharmacist and described the occurrence of a medication error in a 1-day-old subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline). On 29 November 2007 the subject inadvertently received a dose of Fluarix at 0.5 ml. This was considered to be a medication error. The dose of Fluarix was intended for the newborns mother. Fluarix is not indicated for use in subjects under the age of 18 years. The newborn was hospitalized following birth and it was unclear at the time of the reporting whether the medication error would prolong the newborns stay in the hospital. Administration of other vaccines was not known. No adverse events were reported.					Y	0			U	11/29/2007	11/29/2007	0	UNK	PVT	OTH		Unknown	The subject's birth history and the mother's prenatal history were not known. No previous flu vaccines received.		A0697345a	1						1	Inappropriate schedule of drug administration; Medication error; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0298659	12/04/2007	OH	50.0	50		M	12/04/2007	Pt called stating he had memory loss and hosp for encephalitis and meningitis. No further details as he was going to consult with his attorney.  12/31/2007 MR received for DOS 11/11-13/2007 with D/C DX: Aseptic meningitis; Sinusitis, ethmoid and maxillary sinuses. Pt presented to ER with onset of delirium following several days of myalgia, headache, neck pain, flashing lights, R-sided numbness and photophobia.   PE (+) for Temp 100.2'F, and loss of memory of the time pt was delirious.  Exam WNL. Rapidly improved with Acyclovir, Vancomycin and Rocephin. 02/12/2008 MR received for DOS 11/18-19/2007 with D/C DX:  Asceptic meningoencephalitis.  Pt readmitted for 2nd episode of confusion as above, accompanied by 1 week hx of night sweats, diaphoresis, fever/chills and dyspnea.  Headache with scotoma waxes and wanes but has never gone completely away.  Intermittant neck stiffness.  Continued TX with Acyclovir and D/c. Follow-up Information 12-OCT-2008: Patient, a 50 year old male, received an influenza vaccine on November 5, 2007 at a health fair sponsored by the GCRTA. Within 3 hours of the vaccine administration, he apparently began feeling ill with headache, muscle aches and a sore neck. His symptoms continued to worsen and he presented to a medical facility on November 9, 2007. He was evaluated in the emergency department there with a Head CT and was found to have sinusitis. He was treated with azithromycin and discharged. His symptoms continued to worsen and he represented on November 10, 2007 and was re-evaluated with multiple lab tests and a lumbar puncture (LP). The LP revealed abnormal fluid consistent with asceptic (non-bacterial) meningitis. The patient was treated with IV antibiotics and admitted to the hospital. The CSF cultures returned negative as did PCR tests for Herpes viruses. He was subsequently discharged from the hospital but was readmitted to the another hospital on 11/18/07. A repeat LP confirmed the diagnosis of asceptic meningitis and he was placed back on antiviral medication (acyclovir) and discharged to home the next day on acyclovir. In summary, patient had aseptic meningitis with symptom onset within a few hours of receiving an influenza vaccine. The most common cause of aseptic meningitis in the fall of the year is a virus of the enterovirus class which would fit the patient's clinical syndrome. Other causes of the aseptic meningitis syndrome include non-steroidal anti-inflammatory medications such as the naproxen or naburnetone that the patient was taking. Influenza vaccine does not cause aseptic meningitis and has been spcifically shown not to be associated with this syndrome in multiple studies. The influenza vaccine is manufactured with killed viruses so there is no chance of transmitting live influenza virus with this vaccine. In addition, the incubation period for viral (aseptic meningitis) is at least several days conforming that the patient's illness was pre-existing and unrelated to his influenza vaccine. In my opinion, with a high degree of medical certainty, the patient's aseptic meningitis was unrelated to his influenza vaccine. It is likely that he just happened to get the influenza vaccine at the time that he was incubating another virus that caused his meningitis syndrome. With respect to recovery time for aseptic meningitis: most patients recover fully within two to three weeks and can return to work without restrictions. Appropriate treatment for this condition includes intravenous fluid to prevent dehydration during the acute phase with pain medication to relieve headache. Antibiotics are not necessary since it is not caused by a bacterial organism. Antiviral medications can shorten the course of certain types of aseptic meningitis. Aseptic meningitis runs its course in 10-14 days with supportive therapy.					Y	3			U	11/05/2007	11/08/2007	3	Was hosp. and off work for 4 mo from accident 4/07. Labs and Diagnostics: CSF with WBCs 52 and protein 56.  CSF culture (-).  CBC with WBCs 11.3.  Creatinine 1.3.  Blood culture (-).  Stool culture probable psuedomonas.  EEG WNL.  CXR NAD. MRI brain (+) inflammatory change involving ethmoid and maxillary sinuses, otherwise WNL. LP (11/18/07) with WBCs 168 with 93% lymphs, 4 RBCs, protein 115, Glucose 54.  Blood cx (-).	UNK	PVT			PMH:  MVA, anxiety, depression, tension h/a, hypertriglyceridemia, GERD, OA R knee.  Allergic to sulfa and contrast dye.			1						1	Amnesia; Encephalitis; Lumbar puncture abnormal; Meningitis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLAD64AA~6~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation	Influenza
0298662	12/04/2007	TX	41.0	41		F	10/31/2007	Client reports fever of 102.  States she had severe body ache and weakness to the point that she could not walk.  Client was seen in the ER on 10/20/07.				Y					N	10/29/2007	10/29/2007	0	Unknown	PUB	PUB		None	None			1						1	Abasia; Asthenia; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2466AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298664	12/04/2007	TX	4.0	4		F	10/10/2007	None									Y	10/10/2007			None	PVT	PUB		None	Allergic rhinitis		TX0794	1						1	Unevaluable event	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B0997~UNK~~~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2442AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0001~UNK~~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0749U~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1100U~UNK~~~VARICELLA (VARIVAX)~1	USA		Influenza
0298667	12/04/2007	KY	64.0	64		F	10/31/2007	Stated left clinic after flu shot - 7-8 minutes after leaving started smelling musty odor.  Got home and felt strange, started to feel heart rate increase, dizzy, face flushed red.  Many allergies, went to immediate care center.  All symptoms resolved except musty odor.				Y					N	10/30/2007	10/30/2007	0		PUB	PUB	Corzide, Tricor Lotensih, Zettia, Plavix, Nexium, Claritin, Singular, Premarin, Metformin, Xalatineyegitts	None	Hx - heart disease, diabetes, HPT, high cholesterol, many allergies.  Medical allergies to Ceclor, Cipro, Sulfa, PCN.			1						1	Dizziness; Feeling abnormal; Flushing; Heart rate increased; Nasal odour; Parosmia	FLU3~SANOFI PASTEUR~U2510AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298668	12/04/2007	PA	54.0	54		F	11/15/2007	None stated									Y	11/01/2007	11/04/2007	3		MIL	UNK			hypertension, diabetes			1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA296FA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0298669	12/04/2007	KY	1.3	1	.3	M		Patient was brought in on 11-26-07.  Complained of limping on left leg and coping with pain in his leg.  Went to local hospital and was told glands are swollen and has lymph node.  Upon 11-26-07 exam, patient walked with a limp and hardly put any weight on left leg.  Hip normal, neurovascular system intact.  Patient was sent for x-ray and labs.  H-ray of left hip.  11-28-07 am spoke with dad.  Stated is still limping, but is some better.  On 11-29-07 am mother called stating child woke with a rash, no fever, and is acting weak.  RTC in am if no better.  Patient returned to clinic on 11-30-07 pm with complaints of leg limp and body rash.  Skin had maculor rash on trunk.  Left leg drags a bit with ambulation and left foot drags is noted.  Limp is a new onset.  Since immunization with apparent immunization reaction.  He was referred to hospital on that day and given Prednisone  3/4 tsp for 7 days.  Spoke with mom via phone on Dec. 4th.  States patient is still limping a little, but with noticeable improvement.  Can now lift both legs over something.  Instructed her to continue steriods and call us back when completed to check on improvement.										11/19/2007	11/25/2007	6	X-ray of left hip - normal CBC - normal, ESR high.	PVT	PUB		None	None			1						1	Asthenia; Full blood count normal; Gait disturbance; Lymphadenopathy; Pain in extremity; Rash; Rash macular; Red blood cell sedimentation rate increased; Weight bearing difficulty; X-ray of pelvis and hip normal	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B046AA~4~IM~~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~42794AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~09521~1~~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0298670	12/04/2007	VA	2.0	2	.0	F	12/08/2007	urticaria										11/26/2007	12/02/2007	6		PVT	UNK	None	slt cold	Mild hx dysplasia; resolved			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2436AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB175AA~2~UN~RL~HEP A (HAVRIX)~1	USA		Influenza
0298671	12/04/2007	IN	63.0	63		F	12/04/2007	Arm swelling and redness, started 4 hrs after vaccine given.  Tx: Augmentin 875mg and Medrol dose pak x5 days.									U	11/29/2007	11/29/2007	0	None	PVT	UNK		none	DM-2			1						1	Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~U2445AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0989U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0298672	12/04/2007	NC	6.0	6		M	11/21/2007	(R) arm cellulitis vs local allergic reaction to flu vaccine. (R) arm tender, erythemic and swollen. No pus noted, no drainage. Treated with Amoxicillin 400mg given BID PO, Septra suspension 12.5 ml BID.									Y	11/14/2007	11/16/2007	2	None	PVT	PUB		No	None		NC07119	1						1	Cellulitis; Erythema; Hypersensitivity; Local reaction; Oedema peripheral; Tenderness	FLU3~SANOFI PASTEUR~U2490AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1335U~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0298673	12/04/2007	NC	64.0	64		F	11/20/2007	Client came in 11/19 and bruise was noted in (L) deltoid area. Pt reports 11/6 pm arm became sore. Noted 11/20 arm continued to be sore and seems like it is getting worse. No swelling or heat in area. Pt c/o decreased strength and pain with movement that radiate almost to elbow.									U	11/06/2007	11/06/2007	0	None	PUB	PVT	ASA 80 mg qd	None	No		NC07120	1						1	Asthenia; Injection site bruising; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78995~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0298674	12/04/2007	NJ	5.0	5		F	12/04/2007	Urticaria on 11/7/01 and 11/8/07 - periorbital, L cheek, lower abdomen.  No known allergies.  Treated with Zyrtec 1 1/2 tsp QD									Y	11/06/2007	11/07/2007	1	Quick strep, throat culture both negative	PVT	PVT	None	None	None			1						1	Culture throat negative; Streptococcal identification test negative; Urticaria	FLU3~SANOFI PASTEUR~U2475KA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298675	12/04/2007	SC	59.0	59		F	12/04/2007	Patient reports AM after vaccine given - injection site burned while in shower.  Approximately 2 days later site swollen red, with a blister.  No purulent drainage.  Arm not swollen.  Experienced nasal congestion, nasal drainage, raw throat 1-2 days after vaccine without cough or body ache.  Temperature 98.7  as compared to patient's normal 97.6.									Y	10/30/2007	10/31/2007	1		UNK	PUB	Allegra	Completed course of Amoxicillin for a sinus infection one week prior to vaccine administration	Hay fever, asthma, pollen		SC0722	1						1	Body temperature increased; Injection site erythema; Injection site irritation; Injection site swelling; Injection site vesicles; Nasal congestion; Pharyngolaryngeal pain; Rhinorrhoea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80956~5~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0298677	12/04/2007	KY	24.0	24		F	12/04/2007	Member recieved Flumist vaccine, and aprox. 1 hour after noticed hives all over body (legs, arms, torso)and itching sensation on legs. At which point member took 25mg Benadryl. 2 Hours later member took second dose due to the fact that the 1st dose had little effect. Member states woke up in AM and syptoms were gone.									Y	12/01/2007	12/01/2007	0	N/A	MIL	MIL	N/A	Possible onset of UTI				1						1	Pruritus; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0298680	12/04/2007	WA				U	12/04/2007	60 outdated (06/30/07) influenza vaccines were given to employees of Medical Center during the month of November 2007									Y					UNK	UNK						1						1	Expired drug administered; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA206AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0298683	12/04/2007	MI	1.25	1	.3	F	12/04/2007	Night after receiving imms multiple episodes of vomiting; fever; Mom states she was burning up but only temp checked with thermometer was 99.8									Y	11/26/2007	11/27/2007	1		PVT	UNK	Polyviflor	None	None			1						1	Body temperature increased; Feeling hot; Vomiting	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B061AA~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2459KA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~PFIZER\WYETH~BO87020~4~IM~LL~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0298685	12/04/2007	SC	0.33	0	.3	M	12/04/2007	1)Local reaction at injection site (redness, induration) measuring 2x1cm on right thigh, initially evident 24 hours post injection, increased size by 48 hours and then began to resolve (less red, still significant induration). The Dtap and Pneumococcal vaccine was given in this leg. No additional treatment was required.  2) Diarrheal illness following administration of second dose of rotatec (rotavirus vaccine). Symptoms began 48 hours post vaccination and were accompanied by severe vomiting x 12 hours.  The vomiting required adjusting the volume and frequency of feedings to avoid dehydration. Diarrhea continues presently and we are 3 days into the symptoms; vaccine given 11/30/07 3) Diarrheal illness following the first administration of rota virus vaccine- occurred 5 days post administration and lasted 5 days; my son then developed an ear infection and perforated his tympanic membrane requiring 10 days of ciprodex drops and 10 days of amoxicillin				Y					U	11/30/2007	12/02/2007	2	Seen in the pediatricians office after first vaccination and related ear infection.	PVT	PVT	amoxicillin	left otitis media	none	diarrheal illness followed by ear infection in right ear~Rotavirus (Rotateq)~NULL~0.20~In Patient		1						1	Diarrhoea; Ear infection; Injection site erythema; Injection site induration; Tympanic membrane perforation; Vaccine positive rechallenge; Vomiting	DTAP~SANOFI PASTEUR~~UNK~~~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~~UNK~~~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~~UNK~~~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~~UNK~~~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0298687	12/04/2007	PA	52.0	52		F	12/04/2007	When the nurse gave me the injection I felt the normal 'prick' and then at the end I got a split second worth of pain that I would rate as a '5 out of 10'.  So it was sore for a couple of days, and I thought it would go away, but now a month later, it is still not going away and with regular movement such as raising my arm above my head or reach out it really hurts. I am using motrin but as soon as I stop it resumes.									N	11/04/2007	11/04/2007	0	Has not seen PCP and wants to discuss with manufacturer before seeking medical care.	PUB	PVT	None	None	Ulcerative proctitis; Possible start of arthritis (self-diagnosed)	none~ ()~NULL~~In Patient		1						1	Injected limb mobility decreased; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80684~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0298689	12/04/2007	MD	60.0	60		M	12/04/2007	Pt received flu vac in Nov.@ PMD.  24-36 hours later developed deep pain in the upper arm to the shoulder blade and neck.  7 days later, about 2 inches above injection site, pt developed one shingle.  Severe pain x 2 nights, but had pain X 2 weeks.  Went to PMD, received Acyclovir.				Y					Y	11/16/2007	11/17/2007	1	Has not received the Zostavax vac.	PVT	PVT	Compan, Levodopa, Mirapex	Parkinson's	allergic to Reglan,  Parkinson's			1						1	Herpes zoster; Musculoskeletal pain; Neck pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0298690	12/04/2007	OR	7.0	7		F	12/04/2007	FEVER 103 LESS THAN 12 HOURS AFTER FLUMIST ADMINISTERED.  ALSO COMPLAINED OF SORE THROAT, STOMACH ACHE, DIZZINESS, HEADACHE.									Y	12/03/2007	12/03/2007	0		PVT	PVT	NONE	NONE	NONE			1						1	Abdominal pain upper; Dizziness; Headache; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500488P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0298691	12/04/2007	FL	41.0	41		F	12/04/2007	Approximately 1 1/2 hour after receiving vaccines, Carilee experienced a headache, approximately 15 minutes after that she started to experience shortness of breath, Nausea, and she felt very hot, like my skin and hair were on fire. she was also experiencing tightness in her chest. She was seen by the doctor at the Health Department, Her blood pressure was elevated, 160/100. He recommended that she go to the emergency room. She was transported by ambulance. At the hospital she was diagnosed with medication allergy and was sent home with Methylprednisone and Tagamet. She continued to have severe headaches, mild fever, body aches and fatigue for several days after the incident. She continued under the care of a medical doctor for malaise and vomiting until 11/15/2007.				Y					Y	11/02/2007	11/02/2007	0		UNK	UNK						1						1	Blood pressure increased; Chest discomfort; Dyspnoea; Fatigue; Feeling hot; Headache; Hypersensitivity; Malaise; Nausea; Pain; Pyrexia; Skin warm; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80682~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C2730AA~4~IM~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0298692	12/04/2007	IL	55.0	55		F	12/04/2007	Patient states that she had swelling and whelp the size of a softball that lasted for 2 weeks.  The patient states she had pain at the site for the same amount of time.									Y	10/31/2007				UNK	PVT	Estrace Vaginal Cream,Zyrtec 10mg	None	Penicillin			1						1	Injection site pain; Injection site rash; Injection site swelling	FLU3~SANOFI PASTEUR~U2514AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298701	12/04/2007	CA	6.0	6		M	12/04/2007	sl swelling of face night of vaccine admin. Hives the next day, increased in severity over next 2 days. Day one given Benadry, day 2 given Benadryl and Rx for steriods with relief. C/o hives and itching.				Y					Y	11/07/2007	11/07/2007	0		UNK	UNK		none	none			1						1	Pruritus; Swelling face; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500487P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0298702	12/04/2007	CA	0.58	0	.6	F	12/04/2007	Patient returned to health center on 11/29/07 one day after receiving 6 month vaccines plus Flu vaccine.  All sites of administration with erythema and induration; Left thigh with greater degree of symptoms. Also fever since 4 am. Insertion sites less than one inch apart.  Cool compresses and gentle massage ordered to sites, along with body temperature monitoring.									U	11/28/2007	11/29/2007	1		PUB	PUB	NONE	NONE	NONE KNOWN			1						1	Injection site erythema; Injection site induration; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B137AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2475BA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~GLAXOSMITHKLINE BIOLOGICALS~UF223AA~3~IM~LL~HIB (HIBERIX)~1|PNC~PFIZER\WYETH~B54016H~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0298705	12/04/2007	CA	33.0	33		F	12/04/2007	Severe pain in deltoid region (at the site of injection) began within 2 hours of vaccination.  Pain has continued for more than a month with little improvement and consistent worsening. Swelling and pain at more than a month.									N	10/18/2007	10/18/2007	0		PVT	PVT		none				1						1	Injection site pain; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0298707	12/04/2007	WA	21.0	21		M	11/26/2007	Recurring chills, headache, myalgias, arthralgias which started 1 day after receiving flu vaccine.  Sx persistent at 2 weeks.										11/15/2007	11/16/2007	1		OTH	PVT	None					1						1	Arthralgia; Chills; Headache; Myalgia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80825~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0298710	12/04/2007	MA	44.0	44		F	12/04/2007	I got the flu worse with the shot than without it.  I feel more work needs to be done with it before it is administered.  Every year it is the same problem.										10/26/2007	10/29/2007	3		PUB	UNK		I had a simple cold.				1						1	Influenza	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298712	12/04/2007	CA	0.5	0	.5	F		2 small blisters - one on each thigh. (R) thigh approx 1 inch from needle mark anterior. (L) lateral thigh, approx 2 inches from needle site. No redness, no signs of infection.									Y	11/14/2007	11/15/2007	1	None	PVT	PVT	None	None	None			1						1	Blister	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~21B125AB~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~YT249MA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~F212AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B70145E~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~09754~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0298714	12/04/2007	FL	14.0	14		F	11/14/2007	1-2 minutes after administration of both injections she became unresponsive to voice & smelling salts; pale; hypotonic in chair; bradycardic 38 bpm; pulse oximeter 90% - placed on oxygen via rebreather; placed on floor with legs elevated-epinephrine, Benadryl and solumedrol steroid IM-via EMS to hospital.				Y					Y	11/09/2007	11/09/2007	0	Monitored for two hours in hospital E.R.	PVT	PVT	None	None	None known			1						1	Bradycardia; Hypotonia; Oxygen saturation; Oxygen saturation decreased; Oxygen supplementation; Pallor; Unresponsive to stimuli	FLU3~SANOFI PASTEUR~U2490AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~02775AA~4~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0298715	12/04/2007	SC	59.0	59		F	11/26/2007	Same day as shots developed fever, chills, body aches, swelling at sit of pneumovax.				Y					Y	11/14/2007	11/14/2007	0		PVT	PVT		None				1						1	Chills; Injection site swelling; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2526AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1380U~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0298719	12/04/2007	TX	2.0	2	.2	F	10/23/2007	Influenza vaccine administered 10-20-07; 10-22-07 pt. presented in office with a 6cm x 7 1/2cm area of erythema L anterior thigh, no induration, no warmth or tenderness with palpation.									U	10/20/2007	10/21/2007	1		PVT	PVT	Cedax	None	None			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U2499AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298720	12/04/2007	TX	11.0	11		F	10/26/2007	Redness (erythema) & edema at injection site within 24 hours of Varivax #2 given to R lateral upper arm.				Y					Y	10/24/2007	10/25/2007	1	None	PVT	PVT	None	None	None			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U2480CA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1259U~1~IM~RA~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~1176U~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0297720	12/05/2007	NY	12.0	12		F	11/30/2007	Initial report received on 27 November 2007 from a health care provider. A 12-year-old female patient, with a past medical history of asthma, had received a first dose, left arm, intramuscular injection of Adacel, lot number C2862AA; a first dose, right arm, intramuscular injection of Menactra, lot number U2538AA; a seventh dose, left arm, intramuscular injection of Fluzone SV 2007-2008, lot number U2524AA; and a first dose, right arm intramuscular injection of Gardasil, manufacturer Merck, lot number 12676; on 12 November 2007. Four days post-vaccination, the patient experienced an episode of spinning with her head tilted to the right and her whole body shaking. The episode lasted less than two minutes. The patient had no fever at the time of the event. She was transported by emergency medical services to an emergency room where she was subsequently admitted to the hospital with a diagnosis of questionable partial complex seizure versus syncopal episode. The patient was discharged following a three day hospitalization. Two days after discharge, the parent called and stated that the patient had experienced another seizure. She was re-examined and started on Depakote. Relevant diagnostic testing, (dates not provided), included a CT scan of the head which was normal, an EKG which was normal, CBC and electrolytes which were normal, a video EEG (results pending), and a MRI (results pending). Recovery status was not provided.				Y	Y	3			U	11/12/2007	11/16/2007	4	Relevant diagnostic testing, (dates not provided), included a CT scan of the head which was normal, an EKG which was normal, CBC and electrolytes which were normal, a video EEG (results pending), and a MRI (results pending).	PVT	PVT	SINGULAR		The patient had a history of asthma.		200704033	1						2	Blood electrolytes normal; Computerised tomogram normal; Electrocardiogram normal; Epilepsy; Full blood count normal; Nuclear magnetic resonance imaging; Posture abnormal; Syncope; Tremor; Vertigo; Blood electrolytes normal; Complex partial seizures; Computerised tomogram normal; Convulsion; Electrocardiogram normal; Electroencephalogram; Full blood count normal; Nuclear magnetic resonance imaging; Posture abnormal; Syncope; Tremor; Vertigo	FLU3~SANOFI PASTEUR~U2524AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~12676~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2538AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2862AA~1~IM~LA~TDAP (ADACEL)~1|FLU3~SANOFI PASTEUR~U2524AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|HPV4~MERCK & CO. INC.~12676~1~IM~RA~HPV (GARDASIL)~2|MNQ~SANOFI PASTEUR~U2538A~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TDAP~SANOFI PASTEUR~C2862A~1~IM~LA~TDAP (ADACEL)~2	USA	Hospitalisation	Influenza
0298738	12/05/2007	VT	23.0	23		F	12/05/2007	Red circle appeared 2-3 days after vaccine administration on Left Deltoid where vaccine was given.  Skin changes noted and still evident 6 weeks later.  Skin is rough and scaly, no masses or thickening noted at site. No enlarged L axillary nodes.  Patient c/o feeling weak for last month.									N	10/23/2007	10/26/2007	3	CBC, CMP drawn today, results are pending.	UNK	UNK	synthroid, methadone	none	hypothyroidism	none~ ()~~0.00~Patient		1						1	Asthenia; Full blood count; Injection site erythema; Laboratory test; Skin exfoliation	FLU3~SANOFI PASTEUR~U2448AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298765	12/05/2007	AL	55.0			F	12/05/2007	Now presents with erythemia to outer nasal area; nasal pharyngeal and anal discomfort. c/o of swelling and itching of nose. States 24 hours after injection had local redness and itching locally. Dis(?) within a few days.									U					PUB	UNK		No	No			1						1	Discomfort; Erythema; Nasal discomfort; Proctalgia; Pruritus; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA322BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0298766	12/05/2007	MI	55.0	54		M	11/11/2007	Patient returned to pharmacy on 12/03/07 presenting an intense rash reaction on the lefty arm.  The condition of the lesions reflects trauma and secondary infection potentially due to intense itching.  Recommended patient to see his PCP ASAP.  Patient was stable.									U	11/11/2007				UNK	PVT		N/A	N/A			1						1	Infection; Injury; Pruritus; Rash pruritic; Skin lesion	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA319AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0298769	12/05/2007	VA	5.0	5		F	12/05/2007	The evening after vaccination child developed redness, warmth and swelling measuring 7.25 cm horizontally and 9 cm vertically in upper arm where vaccination occured.  The child also had itching and benadryl was given.  Benadryl helped with itching, but the redness, and swelling increased.  Child was seen in office the following morning, 16 hours after first measurement and area of redness, swelling and warmth now measured 12.5 cm vertically and 12.75 cm horizontally.  Plan of care was for Motrin 3 times a day for next two days, and benadryl as needed for itching.  Will plan for further follow-up if increases redness, pain, or changes in sensation occur.									Y	12/03/2007	12/04/2007	1	None	PVT	PVT	None	None	None			1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2527AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298770	12/05/2007	CA	87.0	87		M	12/05/2007	Upon injection into patient's left arm, administrator felt resistance.  No vaccine was injected.  Needle was withdrawn and swelling was observed.  No pain or itching was observed by patient.  Administrator observed patient for several minutes and noticed that swelling decreased.  Patient was sent home for follow-up appointment 3 days later.  Vaccine was administered in right arm with no incidence.									Y	09/24/2007	09/24/2007	0	n/a	UNK	PVT	unknown	none according to screening form	unknown			1						1	Device failure; Injection site swelling	FLU3~SANOFI PASTEUR~U2454AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298772	12/05/2007	IA	60.0	60		F	12/05/2007	Day 1 shot administered 2 hrs later joint pain. Day 2 all over muscle aches. Day 3 101.5 temp muscular aches. Diarrhea. Day 4 same as day 3. Day 5 temp. fluctuated between norm and 100+. Minor muscles aches diarrhea. Day 6 better, similar to day 5. Day 7 back to work.									Y	10/16/2007	10/16/2007	0		UNK	PVT						1						1	Arthralgia; Body temperature fluctuation; Body temperature increased; Diarrhoea; Myalgia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79241~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0298773	12/05/2007	MT	47.0	47		F	12/05/2007	Felt electrical zing when vaccine administered. Has had a chronic deep ache in deltoid for the following month. painful, but not limited range of motion.									U	11/01/2007	11/01/2007	0		PVT	PVT		none	depression			1						1	Injection site pain; Myalgia; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA317AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0298778	12/05/2007	MD	74.0	74		F	12/05/2007	pt immunized at 12 noon and that same evening developed sweeling of left extremity and c/o chills and inability to walk. Pt to the ED and admitted to Hospital. Fever was a one point up to 103.9. Pt was discharge from hospital with diagnosis of bronchitis and a prescription for an antibiotic. Unknown reason for neurological symptoms.  12/18/07 Reviewed hospital medical records which reveal patient experienced cough, congestion, dizziness, chills/fever, SOB, ataxia, swelling & redness of left arm.  Admitted 12/1-12/4/2007. Tx w/IV antibiotics & nebs.  Improved & swelling/redness also improved.  D/C to home w/continued oral antibiotics. FINAL DX: Acute bronchitis, query reaction to pneumo shot.					Y	5			Y	11/30/2007	11/30/2007	0	LABS: WBC 14.2 (H).  Sed rate 44 (H).  CRP 6.4 (H).  Sodium 133 (L). UA WNL.  Blood & urine c/s neg.  CT brain WNL.  MRI brain revealed advanced small vessel ischemic change or periventricular white matter.  MRA WNL.  CXR WNL.	UNK	UNK	Phenobarbitol and dilantin	none	pcn allergy and seizure disorder PMH: macular degeneration.			1						1	Abasia; Chills; Oedema peripheral; Pyrexia	FLU3~SANOFI PASTEUR~U2448aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0298781	12/05/2007	TX	7.0	7		F	12/05/2007	Patient woke-up up with a fever of 103.1.  She was shaking and was weak, dizzy, & a little pale.  She complained that her tongue was burning.  This was on the 1st of December.  I took her to the weekend doctor and had forgot that she had this vaccination, so did not inform them of it. They said they found nothing wrong with her, but again, I did not inform them of this vaccination, because I forgot that she had it. On Sunday, December 2nd, she was hoarse the whole day.  To my knowledge she is ok, but I will call to possibly set up another appointment, if they want to see her.  She had this vaccine done at her school.  They sent home a note with the vaccine information, but I cannot tell the name of the person who administered it.				Y					Y	11/27/2007	12/01/2007	4		UNK	UNK		none	amoxicillin			1						1	Asthenia; Dizziness; Dysphonia; Glossodynia; Pallor; Pyrexia; Tremor	FLUN3~MEDIMMUNE VACCINES, INC.~5004483p~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0298783	12/05/2007	OR	64.0	64		F	12/05/2007	localized red, hard, indurated, painful area at site.				Y					U	12/03/2007	12/03/2007	0		PVT	PVT			leukocytosis			1						1	Injection site erythema; Injection site induration; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA061AA~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0804U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0298795	12/05/2007	IL	81.0	81		U	12/05/2007	This case was reported by a healthcare professional (Chief Executive Officer of a home healthcare agency) and described the occurrence of shortness of breath in a 81-year-old subject of unspecified gender who was vaccinated with influenza vaccine trivalent (Flulaval, GlaxoSmithKline) for prophylaxis. Concurrent medications were not specified. On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date March 2008. In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting. The reaction was classified as systemic. The healthcare professional considered the events were disabling. The reporter suspected a safety and quality issue (product complaint) with the vaccine. At the time of reporting the outcome of the events was unspecified. It was indicated that these events occurred with multiple subjects. Nine specified at the time of the report. It was noted that 2 or 3 subjects had to be treated in the emergency room for these events. Most of the subjects recovered from the events after 2 to 4 days. Some subjects had not yet recovered at the time of reporting. Specifics on each individual subject were not provided.				Y				Y	U	11/01/2007	11/01/2007	0	UNK	PVT	PVT	Unknown	Unknown	The subject has previously received flu shots. No reactions were documented following previous vaccinations in general. This report was provided on multiple subjects. It was noted that some of the subjects experienced reactions to previous flu shots (different reactions than what have occurred now). The reactions were not specified.		A0697385A	1						1	Asthenia; Dyspnoea; Pharmaceutical product complaint; Pyrexia; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA024AA~1~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Disabling	Influenza
0298796	12/05/2007	IL	73.0	73		U	12/05/2007	This case was reported by a healthcare professional and described the occurrence of shortness of breath in a 73-year-old subject of unspecified gender who was vaccinated with Flulaval for prophylaxis. Concurrent medications were not specified. On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date March 2008. In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting. The reaction was classified as systemic. The healthcare professional considered the events were disabling. The reporter suspected a safety and quality issue (product complaint) with the vaccine. At the time of reporting the outcome of the events was unspecified. It was indicated that these events occurred with multiple subjects. Nine specified at the time of the report. It was noted that 2 or 3 subjects had to be treated in the emergency room for these events. Most of the subjects recovered from the events after 2 to 4 days. Some subjects had not yet recovered at the time of reporting. Specifics on each individual subject were not provided.				Y				Y	U	11/15/2007	11/15/2007	0	UNK	PVT	PVT	Unknown	Unknown	The subject has previously received flu shots. No reactions were documented following previous vaccinations in general. This report was provided on multiple subjects. It was noted that some of the subjects experienced reactions to previous flu shots (different reactions than what have occurred now). The reactions were not specified.		A0697384A	1						1	Asthenia; Dyspnoea; Pharmaceutical product complaint; Pyrexia; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA024AA~1~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Disabling	Influenza
0298797	12/05/2007	IL	73.0			U	12/05/2007	This case was reported by a healthcare professional and described the occurrence of shortness of breath in a 73 year old subject of unspecified gender who was vaccinated with Flulaval for prophylaxis. Concurrent medications were not specified. On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date March 2008. In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting. The reaction was classified as systemic. The healthcare professional considered the events were disabling. The reporter suspected a safety and quality issue (product complaint) with the vaccine. At the time of reporting the outcome of the events was unspecified. It was indicated that these events occurred with multiple subjects. Nine specified at the time of the report. It was noted that 2 or 3 subjects had to be treated in the emergency room for these events. Most of the subjects recovered from the events after 2 to 4 days. Some subjects had not yet recovered at the time of reporting. Specifics on each individual subject were not provided.				Y				Y	U		11/01/2007		UNK	PVT	PVT	Unknown	Unknown	The subject has previously received flu shots. No reactions were documented following previous vaccinations in general. This report was provided on multiple subjects. It was noted that some of the subjects experienced reactions to previous flu shots (different reactions than what have occurred now). The reactions were not specified.		A0697383A	1						1	Asthenia; Dyspnoea; Pyrexia; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA024AA~1~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Disabling	Influenza
0298798	12/05/2007	IL	79.0			U	12/05/2007	This case was reported by a healthcare professional and described the occurrence of shortness of breath in a 79-year-old subject of unspecified gender who was vaccinated with Flulaval for prophylaxis. Concurrent medications were not specified. On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date March 2008. In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting. The reaction was classified as systemic. The healthcare professional considered the events were disabling. The reporter suspected a safety and quality issue (product complaint) with the vaccine. At the time of reporting the outcome of the events was unspecified. It was indicated that these events occurred with multiple subjects. Nine specified at the time of the report. It was noted that 2 or 3 subjects had to be treated in the emergency room for these events. Most of the subjects recovered from the events after 2 to 4 days. Some subjects had not yet recovered at the time of reporting. Specifics on each individual subject were not provided.				Y				Y	U		11/01/2007		UNK	PVT	PVT	Unknown	Unknown	The subject has previously received flu shots. No reactions were documented following previous vaccinations in general. This report was provided on multiple sclerosis. It was noted that some of the subjects experienced reactions to previous flu shots (different reactions than what have occurred now). The reactions were not specified.		A0697382A	1						1	Asthenia; Dyspnoea; No reaction on previous exposure to drug; Pharmaceutical product complaint; Pyrexia; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA024AA~1~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Disabling	Influenza
0298799	12/05/2007	IL				U	12/05/2007	This case was reported by a healthcare professional and described the occurrence of shortness of breath in an elderly subject of unspecified gender who was vaccinated with Flulaval for prophylaxis. Concurrent medications were not specified. On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date March 2008. In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting. The reaction was classified as systemic. The healthcare professional considered the events were disabling. The reporter suspected a safety and quality issue (product complaint) with the vaccine. At the time of reporting the outcome of the events was unspecified. It was indicated that these events occurred with multiple subjects. Nine specified at the time of the report. It was noted that 2 or 3 subjects had to be treated in the emergency room for these events. Most of the subject recovered from the events after 2 to 4 days. Some subjects had not yet recovered at the time of reporting. Specifics on each individual subject were not provided.				Y				Y	U		11/01/2007		UNK	PVT	PVT	Unknown	Unknown	The subject has previously received flu shots.  No reactions were documented following previous vaccinations in general.  This report was provided on multiple subjects.  It was noted that some of the subjects experienced reactions to previous flu shots (different reactions than what have occurred now).  The reactions were not specified.		A0697381A	1						1	Asthenia; Dyspnoea; Pyrexia; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA024AA~1~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Disabling	Influenza
0298800	12/05/2007	IL	76.0	76		U	12/05/2007	This case was reported by a healthcare professional (Chief Executive Officer of a home healthcare agency) and described the occurrence of shortness of breath in a 76-year-old subject of unspecified gender who was vaccinated with Flulaval (GlaxoSmithKline). Concurrent medications were not specified. On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date March 2008. In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting. The reaction was classified as systemic. The healthcare professional considered the events were disabling. The reporter suspected a safety and quality issue with the vaccine. At the time of reporting the outcome of the events was unspecified. It was indicated that these events occurred with multiple subjects. Nine specified at the time of the report. It was noted that 2 or 3 subjects had to be treated in the emergency room for these events. Most of the subjects recovered from the events after 2 to 4 days. Some subjects had not yet recovered at the time of reporting. Specifics on each individual subject were not provided.				Y				Y	U	11/15/2007	11/15/2007	0	UNK	PVT	PVT	Unknown	Unknown	The subject has previously received flu shots. No reactions were documented following previous vaccinations in general. This report was provided on multiple subjects. It was noted that some of the subjects experienced reactions to previous flu shots (different reactions than what have occurred now). The reactions were not specified.		A0697380A	1						1	Asthenia; Dyspnoea; No reaction on previous exposure to drug; Pharmaceutical product complaint; Pyrexia; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA024AA~1~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Disabling	Influenza
0298801	12/05/2007	IL	77.0			U	12/05/2007	This case was reported by a healthcare professional and described the occurrence of shortness of breath in a 77-year-old subject of unspecified gender who was vaccinated with Flulaval for prophylaxis. Concurrent medications were not specified. On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date March 2008. In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting. The reaction was classified as systemic. The healthcare professional considered the events were disabling. The reporter suspected a safety and quality issue (product complaint) with the vaccine. At the time of reporting the outcome of the events was unspecified. It was indicated that these events occurred with multiple subjects. Nine specified at the time of the report. It was noted that 2 or 3 subjects had to be treated in the emergency room for these events. Most of the subjects recovered from the events after 2 to 4 days. Some subjects had not yet recovered at the time of reporting. Specific s on each individual subject were not provided.				Y				Y	U		11/01/2007		UNK	PVT	PVT	Unknown	Unknown	The subject has previously received flu shots.  No reactions were documented following previous vaccinations in general.  This report was provided on multiple subjects.  It was noted that some of the subjects experienced reactions to previous flu shots (different reactions than what have occurred now).  The reactions were not specified.		A0697379A	1						1	Asthenia; Dyspnoea; Pharmaceutical product complaint; Pyrexia; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA024AA~1~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Disabling	Influenza
0298802	12/05/2007	IL	84.0	84		U	12/05/2007	This case was reported by a healthcare professional (Chief Executive Officer of a home healthcare agency) and described the occurrence of shortness of breath in a 84-year-old subject of unspecified gender who was vaccinated with Flulaval (GlaxoSmithKline). Concurrent medications were not specified. On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date March 2008. In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting. The reaction was classified as systemic. The healthcare professional considered the events were disabling. The reporter suspected a safety and quality issue with the vaccine. At the time of reporting the outcome of the events was unspecified. It was indicated that these events occurred with multiple subjects. Nine specified at the time of the report. It was noted that 2 or 3 subjects had to be treated in the emergency room for these events. Most of the subjects recovered from the events after 2 to 4 days. Some subjects had not yet recovered at the time of reporting. Specifics on each individual subject were not provided.				Y				Y	U	11/15/2007	11/15/2007	0	UNK	PVT	PVT	Unknown	Unknown	The subject has previously received flu shots. No reactions were documented following previous vaccinations in general. This report was provided on multiple subjects. It was noted that some of the subject experienced reaction to previous flu shots (different reactions than what have occurred now). The reactions were not specified.		A0697378A	1						1	Asthenia; Dyspnoea; Pharmaceutical product complaint; Pyrexia; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA024AA~1~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Disabling	Influenza
0298803	12/05/2007	IL	74.0			U	12/05/2007	This case was reported by a healthcare professional (Chief Executive Officer of a home healthcare agency) and described the occurrence of shortness of breath in a 74-year-old subject of unspecified gender who was vaccinated with influenza vaccine trivalent (Flulaval, GlaxoSmithKline) for prophylaxis.  On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date of March 2008.  In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting.  The reaction was classified as systemic.  The healthcare professional considered the events were disabling.  The reporter suspected a safety and quality issue (product complaint) with the vaccine.  At the time of reporting the outcome of the events was unspecified.  It was indicated that these events occurred with multiple subjects.  Nine specified at the time of the report.  It was noted that 2 or 3 subjects had to be treated in the emergency room for these events.  Most of the subjects recovered from the events after 2 to 4 days.  Some subjects had not yet recovered at the time of reporting.  Specifics on each individual subject were not provided.				Y				Y	U		11/01/2007		UNK	PVT	PVT	Unknown	Unknown	The subject has previously received flu shots.  No reactions were documented following previous vaccinations in general.  This report was provided on multiple subjects.  It was noted that some of the subjects experienced reactions to previous flu shots (different reactions than what have occurred now).  The reactions were not specified.		A0697369A	1						1	Asthenia; Dyspnoea; Pharmaceutical product complaint; Pyrexia; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA024AA~1~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Disabling	Influenza
0298805	12/05/2007					M	12/05/2007	We received the following information on 20 NOV 2007: An adult male patient was vaccinated with an influenza virus vaccine, batch-no. and manufacturer unknown in October 2007. A thrombotic thrombocytopenic purpura was reported one week after the vaccination in October 2007 and the patient was hospitalised. The patient has not yet recovered on date of report. It seems to be unlikely that Fluvirin was used as this vaccine was not distributed to the market in this season.					Y	0			N	10/01/2007	10/01/2007	0		OTH	OTH	Aspirin, Felodipine, Lisinopril, Novomix, Simvastatin, Viagra	Unknown	Diabetes mellitus		MA20071472	1						1	Thrombotic thrombocytopenic purpura	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0298806	12/05/2007					F	12/05/2007	We received from a health care professional the following information on 21 NOV 2007: A female patient was vaccinated with Fluvirin, batch-no. and date unknown, into the rotator cuff.  Patient has lost some functions of the affected arm.  Seriousness criterion: medically significant.  Causality: unrelated.  The wrong vaccine administration is more likely responsible for the complaints.  Expectedness assessment according to SPC/US label: The reported symptoms are not expected after vaccination with Fluvirin.  No change in benefit-risk ratio.  No measure necessary.									N					OTH	OTH	No other medications	Unknown			MA20071482	1						1	Incorrect route of drug administration; Injected limb mobility decreased; Wrong technique in drug usage process	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0298816	12/05/2007	CO	35.0	35		F	12/05/2007	11/12/07-Blurred and double vision 11/13/07-worsening vision 11/17/07- muscle weakness, difficulty swallowing, dizzy, difficulty talking, hospitalized 12/17/07-records received for DOS 11/22-11/25/07-DC DX: Dizziness. Weakness of glossopharyngeal nerve with diminished cough and gag reflex. Dysarthria.  Neurology workup pending.Ten days prior to admission sudden onset of generalized weakness of upper arm and thigh region. No decrase in hand grip. Diplopia with blurred vision. Lightheadedness. Tongue felt thick and difficult to swallow. Six pound weight gain in 10 days. Increased fever blisters. Recent increase in dosage of Levoxyl.				Y	Y	3			Y	11/09/2007	11/12/2007	3	Numerous tests done, results unavailable 12/17/07-records received-Laryngeal swallow showed pooling of solid foodstuffs in pyriform sinus. Cardiology consult. mild congestive cardiomyopathy with an ejection fraction of 50%. HCT 46.1PMH:thyroid disease with elevated TSH level. urine culture e.coli. Acethlch Rec AB <0.30. Mri brain normal . CT chest normal. EEG normal.	OTH	PUB	Levoxyl	No acute illness	Hypothyroidism records received 12/17/07-PMH:Hypothyroidism.			1						1	Diplopia; Dizziness; Dysphagia; Muscular weakness; Speech disorder; Vision blurred	FLU3~SANOFI PASTEUR~U2512AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0298817	12/05/2007	CA	42.0	42		F	12/05/2007	Flu injection given at 820 AM. Pt states she developed hives on arms and chest at 1000 AM. Took 2 Benadryl tablets. Feeling better. Rash improved. Per Dr, pt told to take Prednisone 60mg today and call in the AM with update.									Y	12/05/2007	12/05/2007	0	None	OTH	OTH	None	None	None			1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~U2524AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298820	12/05/2007	CA	1.5	1	.5	F	12/05/2007	Reoccurring hives, had shots on Thursday, first incident of hives on Friday AM & then twice more throughout the day; again x2 on Sat and again x2 on Sunday, stopped 6 00/p Sunday evening.  Temp 99.2 (ear), no difficulty breathing or swallowing at any time; patient was given Benadryl per MD on Sat and Sunday.				Y					Y	11/29/2007	11/30/2007	1		PUB	UNK						1						1	Body temperature increased; Urticaria	FLU3~SANOFI PASTEUR~UT2459NN~3~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB181AA~2~IM~UN~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~B58845C~5~IM~UN~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0298822	12/05/2007	MA	0.3	0	.3	M	11/30/2007	None										10/13/2007	11/28/2007	46		PVT	PVT		None				1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~UT2459UA~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298824	12/05/2007	MI	54.0	54		F	12/04/2007	Patients skin is puckered/indented at site of injection. Patient states no pain or itching or discoloration, she just noticed it about 1 month after being vaccinated.									N	10/09/2007	11/05/2007	27	N/A	OTH	OTH	N/A	N/A	N/A			1						1	Injection site reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA298AA~3~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0298825	12/05/2007	SC	4.0	4		M	12/05/2007	12-5-07 615 AM woke, went to bathroom fell on floor < 3 sec. Mom found him whole body shaking, very tense, lying on back, neck rigid, eyes rolled back. Mother states lasted < 5 sec. Child woke stating I fell down - no temp.				Y					Y	12/04/2007	12/05/2007	1		PVT	PVT	Motrin	None	None			1						1	Fall; Gaze palsy; Nuchal rigidity; Tremor	DTAP~SANOFI PASTEUR~C2765AA~5~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2457F~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0273~4~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0280U~2~UN~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1460U~1~UN~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0298826	12/05/2007	OK	64.0	64		F	11/23/2007	Swelling, red, rash, urticaria, hives (R) arm, HA.				Y					Y	11/03/2007	11/03/2007	0	None	PVT	OTH	None					1						1	Erythema; Headache; Rash; Swelling; Urticaria; Burning sensation; Pain in extremity; Tinnitus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~00886F~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~~UNK~UN~RA~PNEUMO (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0298827	12/05/2007	NY	56.0	56		F	11/27/2007	Pt experienced lightheadedness & a rapid heart rate.  1:27pm BP 146/94 AR 120; 1:35pm BP 130/80 AR 110; 2:10pm BP 120/82 AR 78; 2:35pm BP 128/78 AR 82									Y	11/27/2007	11/27/2007	0	None	OTH	OTH		None				1						1	Blood pressure; Dizziness; Heart rate; Heart rate increased	FLU3~SANOFI PASTEUR~U2527AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298826	12/06/2007	OK	64.0	64		F	11/26/2007	Burning in lungs, Hives rt arm-severe burning Right arm fr elbow up very-painful Ringing in ears				Y					Y	11/01/2007	11/01/2007	0		PUB	UNK		None				1						2	Erythema; Headache; Rash; Swelling; Urticaria; Burning sensation; Pain in extremity; Tinnitus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~00886F~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~~UNK~UN~RA~PNEUMO (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0298853	12/06/2007	AL	11.0	11		F	11/16/2007	Rash (whelps)-arm-onset 10/27/07-per mother's report-contacted PMD--gave Benadryl & went to ER-rash also on neck area--improvement past Benadryl--mother says PMD told her that rash might not be related to vaccine. Rash resolved & no further problems.				Y					Y	10/26/2007	10/27/2007	1		PUB	UNK	None	None	Defect of kidneys--one undeveloped & one with 2 ducts			1						1	Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80956~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0298863	12/06/2007	KS	4.0	4		M	12/06/2007	Patient broke out in hives approximately 2 hours after vaccine administration.  Had hives on torso & neck.  Also complained of a sore throat, but had that complaint off and on for 3 days prior.  Patient's doctor notified, Benadryl to be given at home.									Y	12/05/2007	12/05/2007	0		PUB	PUB	none	none	none			1						1	Pharyngolaryngeal pain; Urticaria	FLU3~SANOFI PASTEUR~U2461BA~2~ID~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB218AA~2~ID~RL~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1563U~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0298873	12/06/2007	OH	24.0	23		F	12/06/2007	red,raised hives, itching, Shortness of breath, hoarseness, feet swollen. Pt seen in the office 24 hrs after receiving Influenza injection. Pt was given a steroid shot and given Prednisone pack.				Y					Y	11/15/2007	11/16/2007	1		UNK	UNK		None	Med Allergies:  Ceclor.  Hx of Venal Galen malformation of the brain from birth, seizure disorder associated with Venal galen malformation.			1						1	Dysphonia; Dyspnoea; Oedema peripheral; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~v2492aa~UNK~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298874	12/06/2007	MN	34.0	34		F	12/06/2007	Tdap administered to patient on 10/22/07 and 11/19/07.  The second dose was incorrectly ordered due to: the patient could not recall the first immunization 1 month prior; and the patient's medical record could also not be found on the 11/19/07 clinic visit.  No adverse reaction has been reported at this time.									Y	11/19/2007	11/19/2007	0	N/A	UNK	UNK		N/A	N/A			1						1	Inappropriate schedule of drug administration; Medication error	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80435~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C2826AA~2~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0298878	12/06/2007	TX	26.0	26		M	12/06/2007	Pt noted prolonged tension type headache 2 and 13 days after flu vaccine.									U	11/23/2007	11/25/2007	2		MIL	UNK	none	none	none			1						1	Tension headache	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0298879	12/06/2007	MN	42.0	42		M	12/06/2007	Patient came to the Clinic (where he rec'd his vaccine)12/4/07 for another purpose and reported that after the vaccine 11/8, he had significant swelling in right upper arm, severe pain, and decreased shoulder movement d/t pain. He self-treated w/ ice, ibuprofen, and homeopathic remedy with marked improvement, but still some pain. On exam, 26 days post vaccine, he did have a fullness/swelling in the medial aspect of the upper arm, no discrete adenopathy, no warmth or erythema. He also exhibited some pain on motion, as when he dressed/undressed for exam. I advised him to continue his current sx management, as it is working, and i will re-examine him when he returns to our clinic 12/27, again for another reason.  I also advised him to see his primary clinic if he experiences fever, worsening of symptoms, or new symptoms.									U	11/08/2007	11/08/2007	0		UNK	UNK		None	None			1						1	Injected limb mobility decreased; Oedema peripheral; Pain in extremity	FLU3~PFIZER\WYETH~80070~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|TDAP~SANOFI PASTEUR~C2734AA~UNK~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0298884	12/06/2007	MI	48.0	48		F	12/06/2007	left arm at administration site red, sl.swollen, warm to touch.  Seen in ER.  Prescribed Keflex, Diflucan.				Y					Y	10/31/2007	10/31/2007	0		MIL	PVT						1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2465AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298891	12/06/2007		55.0			F	12/06/2007	We received from a health care professional the following information on 29 NOV 2007: A 55-year-old female patient born on 29 SEP 1952, was vaccinated with Fluvirin (batch no. 81274) i.m. on an unspecified date. The patient had stroke after getting flu vaccine. She got tingling and numbness in the same arm as the vaccine was given right after vaccination. The patient was hospitalised (dates are unknown).									U					OTH	OTH	No other medications	Unknown			MA20071576	1						1	Cerebrovascular accident; Hypoaesthesia; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81274~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0298899	12/06/2007	OR	66.0	66		F	11/13/2007	TC from client. She got cellulitis; fluzone - U2243AA (R) deltoid; pneumovax - 100SF (R) deltoid; hospitalized for 4 days.   12/11/07 Reviewed hospital medical records which reveal patient experienced intractable right arm pain & fever x 1 day.  Admitted 11/10-11/12/2007. Temp on admit 101.5.  Right deltoid was indurated, blotchy, erythematous, warm & exquistitely tender to palpation.  Tx w/IV antibiotics.  Developed hypotension, weakness & nausea while hospitalized but arm pain improved.  D/C to home on continued oral antibiotics.  Patient returned to PCP on 11/16.  Antibiotic was causing N/V.  Continued to have pain of RUE but much less.  Denied any prior reaction to flu shot 7 this was first pneumo shot.  Exam at that time revealed erythema & tenderness of right deltoid.  Antibiotic d/c'd at that time w/only 1 day left. FINAL DX: intractable right arm pain & fever probably secondary to a reaction caused by either the Pneumovax or influenza vaccine.				Y	Y	4			Y	11/08/2007	11/09/2007	1	cellulitis (R) deltoid, shoulder LABS: WBC 12.4 (H).  Chemistry WNL.  US of RUE revealed fluid collection in SQ tissue. CXR abnormal for left hemidiaphragm mass which was known previously.  Blood c/s neg.  RUE x-ray WNL.	PUB	PUB	Levothyroxine	None	Thyroid probs		OR200748	1						1	Cellulitis	FLU3~SANOFI PASTEUR~U2443AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1005F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0298900	12/06/2007	SC	45.0	45		M	12/03/2007	Tingling in fingers and toes moved up into hands and feet. Saw Dr. - referred to seen Dr. 1/8/08-records received for DOS 11/24/11/29/07-DX DC: Guillain-Barre sydrome. Admitted with progressive weakness over four to five days onset approximately two weeks after received flu vaccine. Noticed tingling in extremities, began in his feet and gradually worked up his legs and into his hands. Difficulty with walking unable to maintain gait and fell. Treated with IVIG. At discharge able to ambulate with a walker.				Y	Y	5			U	11/04/2007	11/18/2007	14	Neurology nerves conduction studies. Blood work - done at Doctors office. no reflexes - spinal tap was done at hospital 1/8/08-records received-Nerve conduction studies revealed mild slowing of distal conduction and several motor nerves and possibly absent F waves. Spinal fluid elevated protein.	UNK	UNK			1/8/08-records received-PMH: Hyperlipidemia, hay fever, left shoulder arthroscopic surgery and history of jaw advancement.			1						1	Blood test; Lumbar puncture; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFL1A032AA~1~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation	Influenza
0298901	12/06/2007	OH	48.0	48		M	11/24/2007	Demylinated peripheral neuropathy treatment: IV IGG, Lyrica, Ultracet  2/5/08 Reveiwed only EMG & lab reports from hospital.  EMG report states pt dx w/demyelinating neuropathy, improved w/IVIG but continued to have residual numbness of feet & fingers.  T/C to med recs to request complete med recs. 2/22/08 Received only EMG/NCS dated 12/28/2006 which was abnormal & indicative of an acquired demyelinating sensory motor polyneuropathy c/w GBS; however, early CIDP could not be excluded.  Pt w/ 4 wk hx of progressive numbness of feet & hands w/weakness starting 2 wks s/p flu vax.  Neuro exam on 12/28/06 revealed left hip flexor weakness, DTRs 1+ in arms & absent in legs & sensory gradient to pin prick at knee level.  T/C to med recs to check status of complete med recs as requested.  4/8/08 Reviewed PCP medical records which were just the neurologist reports of 12/22/2006-1/5/2007. FINAL DX: acute demyelinating neuropathy, probable GBS. Patient had developed subacute progressive tingling in hands/feet & difficulty w/fine motor movements with significant discomfort.  Exam of 12/22/07 revealed LUE weakness, slight LE weakness, LE absent reflexes, LE & hands diminished sensation, wide based guarded gait.  Referred for labs, LP & EMG/NCS.  Developed severe positional headache.  Referred for IVIG x 5 days. Per 60 day follow up: Permanent nerve damage in lower legs, ankles, feet, (both legs), arms, elbows, wrists and hands. Loss of feeling numbness, tingling, burning, pain.				Y				Y	N	11/10/2006	11/23/2006	13	Blood tests; MRI-Brain; Lumbar puncture; EMG; Nerve conduction study  Labs of 12/22/2006: RA factor, chemistry, Vit B12, folate, ESR, hepatitis serology, IgG, IgA & IgM all WNL.  CRP 5.96 (H).  CSF  protein 83 (H), glucose 66 (N).   EMG/NCS revealed acute demyelinating neuropathy c/w Guillain Barre syndrome. LABS of 6/1/2007: EMG/NCS revealed marked improvement of demyelinating peripheral neuropathy compared w/study of 12/2006 w/residual left ulnar neuropathy at elbow w/o evidence of distal axonal degeneration.  .  Labs were WNL.  LP done 1/2/2007 which revealed CSF protein of 81 (H) w/all cell counts WNL.	OTH	PVT		None	FOOD ALLERGIES: LEGUMES, WATERMELONS, SHRIMP  PMH: newly diagnosed diabetes, hypertriglyceridemia, HTN, DJD.  Lumbar  surgeries x 2.  Allergy: augmentin & peanuts.  Ex-smoker.			1						1	Anti-cyclic citrullinated peptide antibody; Dyskinesia; Hypoaesthesia; Lumbar puncture; Nuclear magnetic resonance imaging brain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~Z1213~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0298902	12/06/2007	HI	0.7	0	.7	F	11/29/2007	Infant had fever, body stiffening and APNEA (Seizure).  12/14/07 Reviewed hospital medical records which reveal patient experienced staring episode then began shaking all extremities then stopped breathing.  Then started crying inconsolably.  Postictal in ER.  Admitted 11/21-11/22/2007. Sepsis w/u & LP done.  No further seizure activity in hospital but was very sleepy.  Temp on admit 39.8.  Received IM antibiotics.  D/C to home on continued antipyretic to f/u w/pcp. FINAL DX: febrile seizure.				Y	Y				Y	11/21/2007	11/21/2007	0	CBC, blood culture, UA with culture, CSF (All normal) LABS: blood, urine & csf cultures all neg. CSF WNL.WBC 11.3 (N), Neutros 71% (H), lymphs 23% (L). Chemistry WNL. UA WNL.	PVT	PUB	None	None	None			1						1	Apnoea; Blood culture negative; Convulsion; Culture urine negative; Full blood count normal; Musculoskeletal stiffness; Pyrexia; Urine analysis normal	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B129AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2477BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF164AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B47300F~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0298905	12/06/2007	VA	0.5	0	.5	M	11/30/2007	Patient collapsed while eating breakfast at home.  He was taken to the ER and pronounced dead.    12/18/07 Reviewed hospital ER records which reveal patient in usual state of health on 11/27 when coughed & then collapsed at home.  Was unresponsive in ER & resuscitation unsuccessful. ER COD stated as sudden cardiac death.  1/21/08 Reviewed autopsy report which states COD as complication from congenital cardiac disease (probable arrhythmia.	Y	11/27/2007							N	11/26/2007	11/27/2007	1		PVT	PUB	Also received Synagis at the same time	URI	Pulmonary atresia s/p VP shunt/HIV exposure PMH: chronic hypoxia.  Had cardiac cath done 11/20/07.			1						1	Death; Syncope	FLU3~SANOFI PASTEUR~UT2474CA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0298906	12/06/2007	TN	0.84	0	.8	M	12/06/2007	Fever, vomiting, no diarrhea. 12-3-07 after returning home. 12-4-07 to ER 9 AM, seizures. 12/07/07-records received-from transferring facility for DOS 12/4/07-status epilepticus or seizure activity. Day before he started seeming sick, specifically vomited and had a fever. On morning of admission vomited again and seemed febrile. Intubated. At time of transfer had semi purposeful and less tonic contraction in muscles of arms and legs. No seizure activity in his eyes. Some skewed deviation. 12/12/07-records received for DOS 12/4-12/6/07- DC DX: Febrile Seizure.				Y	Y	2			Y	12/03/2007	12/03/2007	0	12/12/07-records received-CT scan negative. CBC, Chem normal. Cultures no growth. Sodium 127. Blood sugar 151.	PVT	OTH		None	Hypospadius			1						1	Convulsion; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~UT2477FA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0298907	12/06/2007	TX	22.0	22		M	12/06/2007	Pericarditis diagnosed with EKG changes.  12/7/07 Reviewed clinic medical records which reveal patient experienced dussen onset diffusechest pain, inability to lie down or tke deep breaths.  Went to ER & admitted 12/2-12/3/2007 for cardiac w/u.  Seen in cardiology clinic 12/4/07   FINAL DX: acute pericarditis. 12/18/07 Received v/m from reporter w/vax lot #.  VAERS database updated w/same.			Y	Y	Y	2			Y	11/30/2007	12/02/2007	2	Elevated S-T segments; EKG chest leads. LABS: 12/4/07 CBC & chemistry WNL.  CK-MB neg.  CRP 5 (H).  ESR 4 (N).  CXR WNL.  Echocardiogram WNL.  EKG revealed ST elevations.	MIL	MIL	None	None	None PMH: patellofemoral syndrome; myalgia, myositis, congenital scoliosis, disc degeneration, stress fracture, OA, cervicalgia, overweight, back strain, anxiety.			1						1	Electrocardiogram ST segment elevation; Electrocardiogram abnormal; Pericarditis	FLUN3~MEDIMMUNE VACCINES, INC.~500502P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Life Threatening,Hospitalisation	Influenza
0298908	12/06/2007	MH	40.0	44		M	12/06/2007	Right arm red, sore, warm to touch.  Went to ER. Diagnosed Celluclitis.  Prescribed Keflex.				Y					Y	10/31/2007	10/31/2007	0		PVT	PVT		unknown				1						1	Cellulitis; Erythema; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~U2465AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298913	12/06/2007	CA	79.0	79		F	12/06/2007	Sorness at site of injection that has continued from the day of the injection until now.(It still hurts to lay on that arm at night in bed.) Never any redness,swelling, radiating pain or swollen glands or fever.									N	10/30/2007	10/30/2007	0	None	PUB	PUB	Vitamins	None	Multiple System Atrophy      Daughter gives her Vitamin B12 injections.			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U2509AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298914	12/06/2007	IA	1.5	1	.5	U	12/06/2007	Patient was given two doses of MMR Proquad and Dtap, one on 8-31-07 and the other on 11-1-07.									Y	11/01/2007				PVT	PVT						1						1	Inappropriate schedule of drug administration	DTAP~SANOFI PASTEUR~C2607AA~UNK~ID~UN~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2516AA0~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~GLAXOSMITHKLINE BIOLOGICALS~0073U~UNK~IM~UN~HIB (HIBERIX)~1|MMRV~MERCK & CO. INC.~1482F~UNK~SC~UN~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0298915	12/06/2007	AZ	4.0	4		F	12/06/2007	GENERALIZED PAPULAR RASH				Y					U	12/05/2007	12/06/2007	1	NONE	UNK	UNK		NO				1						1	Rash papular	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B051AA~5~IM~RA~DTAP (INFANRIX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79898~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~Z0547~3~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0424U~3~SC~RA~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|VARCEL~MERCK & CO. INC.~1269U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0298916	12/06/2007	KY	63.0	63		F	12/06/2007	Vaccine was administered on 11/07/2007.  Pt stopped by pharmacy on 12/5/07 and let me know that her arm had been very sore and stiff since the injection.  She had no bruising, swelling, bleeding, etc, just stiffness and pain.  She did not complain of pain at time of injection.  She did state that it began after the injection.									U	11/07/2007	11/08/2007	1	none	UNK	UNK						1						1	Musculoskeletal stiffness; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua303aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0298917	12/06/2007	OR	6.0	6		F	12/06/2007	48 hours after immunization a 14 by 13 cm area of erythema and a 8 by 5 cm area of induration.  The area was itchy to the patient and not painful.									U	12/04/2007	12/05/2007	1		PVT	UNK	None	None	None			1						1	Erythema; Induration; Pruritus	FLUN3~MEDIMMUNE VACCINES, INC.~500490p~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~1474u~2~IM~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0298918	12/06/2007	WA	46.0	46		M	12/06/2007	appx 6 hours after immunization given, patient started to feel swelling and itching in eyes which proceeded over the next few hours into high fever (105), chills, disorientation, and other frightening symptoms. Patient will never receive a vaccine again. He is not allergic to eggs.									Y	12/02/2007	12/02/2007	0		UNK	UNK						1						1	Chills; Disorientation; Eye pruritus; Eye swelling; Pyrexia	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0298926	12/06/2007	PA	63.0	63		F		Local reaction at inj. site. 4 in diameter, reddened area. Area firm and warm to touch. Pt's BP 145/82.									U	11/01/2007	11/01/2007	0		OTH	OTH			Sulfa, Flagyl			1						1	Injection site erythema; Injection site induration; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~AFLLA053AA~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0298928	12/06/2007	OH	0.7	0	.7	F	11/30/2007	Fever, anorexia, vomiting and crying developed about 4 hours after Fluzone administration (first dose). Symptoms continued for about 48 hours and then completely resolved by 72 hours (Fever max was 102).				Y					Y	11/26/2007	11/26/2007	0	None	PVT	PVT	None	None	None			1						1	Anorexia; Crying; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2510AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298929	12/06/2007	TX	59.0	59		F	11/09/2007	Soreness in left upper arm for 4 weeks without resolution.  Hard to move left arm, painful				Y					N	10/21/2007	10/21/2007	0		OTH	PVT		None noted				1						1	Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2510AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298930	12/06/2007	MO	43.0	43		F	11/27/2007	Within minutes of the injection, shoulder pain started and hasn't resolved, now fourth week later.  Symptoms: dull ache in right shoulder, twinging pain with lifting arm, inability to use arm for some daily functions due to pain/weakness, pain at night, pain with palpatations at site of injection, treatment so far - ice or heat, ROM, Ultrasound.									N	10/26/2007	10/26/2007	0		OTH	OTH	None	None	None			1						1	Injected limb mobility decreased; Injection site pain; Muscular weakness; Musculoskeletal pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78480~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0298932	12/06/2007	OH	35.0	35		F	11/25/2007	Severe headaches had to see private doctor (also noted) vomiting Dr prescribed Maxalt-MH 10 mg tab				Y					U	11/06/2007	11/06/2007	0		PVT	PVT	diabetic meds, Metformin-insulin	Severe headaches	Controlled diabetic			1						1	Headache; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0298933	12/06/2007	VA	0.8	0	.8	M	11/30/2007	Rxn - vomiting, paleness, fever, tachypnea. Tx - Motrin at hospital				Y					Y	11/29/2007	11/29/2007	0		PVT	PVT	N/A	N/A	N/A			1						1	Pallor; Pyrexia; Tachypnoea; Vomiting	FLU3~SANOFI PASTEUR~UT2456BA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298936	12/06/2007	OK	49.0	49		F	11/24/2007	I had the flu shot 11-7-07 at around 11:00 am. At around 11:00 pm. I woke up itching all over. By 4:00 a.m. 11-8-07 I had hives all over. I went to the emergency room and was treated. I also had chills. This lasted through Friday evening. 11-9-07				Y					Y	11/07/2007	11/07/2007	0		UNK	PUB	Lisinopril, Amaryl, Metformin, Levothyroxin	None	allergic to yellow jacket stings as a child			1						1	Allergy to arthropod sting; Chills; Pruritus generalised; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0298937	12/06/2007	MN	19.0	19		M	11/27/2007	Mom reported the evening of the shot (shot given at 210 PM) he experienced dizziness all the time and his color was bad. He's achy and also had a sore throat. Dizziness and paleness continued about a couple days so that's why she called us 11-16-07. He did go back to work, but very groggy and tired - lethargic.										11/13/2007	11/13/2007	0	He hasn't wanted to go to the doctor. I continue to rec. that as he still doesn't feel good (11/27/07).	PUB	PVT			Denies			1						1	Dizziness; Fatigue; Lethargy; Pain; Pallor; Pharyngolaryngeal pain; Somnolence	FLU3~SANOFI PASTEUR~U2511AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298938	12/06/2007	WA	57.0	57		F	11/26/2007	Nov. 2 - Friday - By next morning heart was erratic, pounding, extremely rapid.  Nov. 3 - Saturday - even worse - Sunday - somewhat better.  Monday - called health department.  Saw doctor at 12:00.  Heart monitor for 24 hours.  1 week before results, some improvement.  Nov 12 thru Nov. 16, cardiologist, more improvement.  Today, Nov. 25, still had some erratic throughout day.  Called health department.				Y					N	11/01/2007	11/02/2007	1	Heart monitor results - 3100 PVO/75	PUB	UNK	Rifampin, Ethenbutol, Clarithromycis		Mycobacterium Avium			1						1	Electrocardiogram ambulatory; Heart rate increased; Palpitations	FLU3~SANOFI PASTEUR~U2439AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298939	12/06/2007	WI	50.0	50		F	11/29/2007	Large local reaction in left deltoid area with hardened lump and soreness.  States soreness went up into her neck.  Had sinus congestion, no temp.									U	11/27/2007	11/28/2007	1	None	PVT	PVT		sinus congestion	dyslipidemia, hypertension, migraine			1						1	Induration; Local reaction; Mass; Neck pain; Pain in extremity; Sinus congestion	FLU3~SANOFI PASTEUR~U2499AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298940	12/06/2007	MN	49.0	49		F	11/26/2007	Arm within a few hrs of the vaccines turned red, hot & swollen.  Took 5 days for symptoms to resolve on their own.									Y	11/01/2007	11/01/2007	0		PVT	PVT	Claritin, albuterol, Prozac, Flexerall, Tylenol #3, amitriptyline	None	allergies: Lincocin, dust & mold; asthma & MS			1						1	Erythema; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U2466AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2842AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0298941	12/06/2007	MN	6.0	6		M	11/29/2007	Large local Rxn 24 hours after flu shot.  Left arm swollen and tense shoulder to elbow, with redness. Warmth, mild discomfort on arm and hand.  Neurovascular intact.									Y	11/28/2007	11/29/2007	1		OTH	OTH		None	None			1						1	Discomfort; Erythema; Local reaction; Oedema peripheral; Skin warm; Tension	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0298942	12/06/2007	IL	7.0	7		F	11/19/2007	Big red hive on left cheek which was hot and to touch, then migrated to the ear 2 days later. Cheek was then blotchy with a red mark across the upper lip. Physical symptoms ceased on 11-19-07. Later ran a fever for 6 days on and off.				Y					U	11/01/2007	11/01/2007	0		PVT	PVT	None	None	None			1						1	Erythema; Pyrexia; Rash macular; Skin warm; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0298943	12/06/2007	WA	14.0	14		M	11/20/2007	Area of warmth, redness and swelling from above elbow to mid arm approx 3-5.  Mom is RN, didn't want appointment, will just observe.									Y	11/05/2007	11/07/2007	2	None	PVT	PUB		None	None			1						1	Erythema; Oedema peripheral; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~U22443AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARCEL~MERCK & CO. INC.~1359U~UNK~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0298944	12/06/2007	CA	58.0	58		F	11/07/2007	large induration approx 8 am mottled redness patchy areas length of upper (Rt) arm noticed at hosp. 11-6-07 pain increased, ice x 2 1:30 pm/ 6 pm									Y	11/06/2007	11/06/2007	0		OTH	UNK		None	None			1						1	Erythema; Induration; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80958~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0298945	12/06/2007	OR	2.0	2	.0	M	11/21/2007	(L) thigh red, warm, swollen. The reaction started on 11/19/07 right after immunizations were given but progressively worsened over the next 24 hours.									Y	11/19/2007	11/19/2007	0	N/A	PVT	PVT		Nasal congestion	None			1						1	Injection site erythema; Injection site swelling; Injection site warmth	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B124DB~4~UN~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2444AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1180F~1~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0298946	12/06/2007	CA	67.0	67		F	10/19/2007	Pt said she has/having pain on her left arm, and its painful to lift up her arm, especially from the shoulder to elbow. Analgesics and patches helped a little, but still has the same intensity of pain as before. She got the flu vaccine on 10/10/07.									N	10/10/2007	10/10/2007	0		PUB	PVT		None				1						1	Injected limb mobility decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA311BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0298947	12/06/2007	AZ	15.0	15		F	11/26/2007	Syncopal episode, eyes rolled back, 2 tonic clonic jerks and then awake and alert. Episode lasting 30-40 seconds.									Y	11/26/2007	11/26/2007	0		PVT	PUB		Strep pharyngitis				1						1	Gaze palsy; Syncope; Tonic clonic movements	FLU3~SANOFI PASTEUR~U2461DA~4~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0928U~1~UN~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~2378BA~1~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0298948	12/06/2007	CA	7.0	7		M	11/28/2007	13 days after the flu vaccine, patient developed Bell Palsy right side of face.  Patient recovered p.o. steroid.  12/18/07 Reviewed ER medical records which reveal patient experienced acute onset right sided facial droop, unable to close right eye or furow forehead.  Tx w/steroids & antiviral meds & to tape eye at night. PMH: seasonal allergies FINAL DX: Bell's palsy.				Y					Y	11/12/2007	11/25/2007	13	None	PVT	UNK		None	Healthy			1						1	Facial palsy	FLU3~SANOFI PASTEUR~U2476HAAR~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298949	12/06/2007	MI	70.0	70		F	11/09/2007	Received flu vaccine in left arm and Pneumonia vaccine in right. Left arm swollen and sore. 8 pm felt quite ill, warm. 11:15 pm Checked Temp 100.9 BP up. Felt tired.									Y	11/05/2007	11/05/2007	0	Pulse 135 Blood Pressure up (153)	PVT	OTH	Evista 60mg, Pred. 4 mg, Evoxac 30 mg 3x	None	Sjogren's Syn.; Interstitial Cystitis			1						1	Blood pressure; Blood pressure increased; Body temperature increased; Fatigue; Feeling hot; Heart rate; Malaise; Oedema peripheral; Pain in extremity	FLUX~SANOFI PASTEUR~C2465aA~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0993U~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0298950	12/06/2007	WA	0.8	0	.8	M	11/29/2007	Next day after receiving vaccine noticed a red swollen quarter sized bump over right thigh - injection site.  Given Motrin.									Y	11/15/2007	11/16/2007	1	None	PVT	PUB	N/A	N/A	N/A			1						1	Injection site erythema; Injection site reaction; Injection site swelling	FLU3~SANOFI PASTEUR~UT2474AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~AQ1692~3~~RL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~B08666F~4~~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0298954	12/06/2007	IN	67.0	67		F	11/28/2007	Patient went to doctor's office and complained of pain in shoulder that radiated to the arm.  Doctor said a possible explanation could be due to flu vaccine.									Y	10/23/2007				OTH	OTH	Potassium chloride, Januvia, Synthroid, Torsemide, coumarin					1						1	Musculoskeletal pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2528AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298957	12/06/2007	SC	82.0	82		F	11/27/2007	Broke out with shingles one week after receiving shingles vaccine.  Doctor prescribed Famciclovir tab 500 mg which was taken for 7 days. This is in follow-up to report(s) previously submitted on 12/21/2007. Information has been received from a pharmacist concerning an 82 year old female, with no medical history and no known drug allergies, who on 09-NOV-2007 was vaccinated with a 0.65 ml subcutaneous dose of ZOSTAVAX (Lot# 658084/0888U). Concomitant vaccine included a dose of influenza virus vaccine (unspecified). On 15-NOV-2007 the patient had a shingles outbreak. The patient was seen by a physician and was prescribed FAMVIR. The patient's shingles persisted. No product quality complaint was involved. Additional information has been requested.				Y					U	11/08/2007	11/14/2007	6	None	OTH	OTH			None		WAES0711USA03445	1						1	Herpes zoster; Herpes zoster	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~0888U~UNK~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1|VARZOS~MERCK & CO. INC.~0888U~UNK~SC~UN~ZOSTER LIVE (ZOSTAVAX)~2	USA	Emergency room visit	Influenza
0298958	12/06/2007	MI	1.95	1	1	F	11/27/2007	Patient given flu mist 14 days prior to 2nd birthday.									U	10/14/2007			Unknown	PVT	PVT		Bronchitis	N/A			1						1	Inappropriate schedule of drug administration; Medication error; Wrong drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500486~2~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0298959	12/06/2007	WY	65.0	65		F	11/27/2007	Client tCD.  L influenza, R pneumovax at clinic 11-16-07.  11-19-07 reported to PHN had a severe reaction R arm with fever (102) chills, severe swelling at site with marble-sized lump at injection site.  Did not seek ER but spent 5 days in bed.  Advised by PHN to report reaction to family doctor. Do not repeat pneumovax without Dr order.									Y	11/16/2007	11/17/2007	1	None	PUB	PVT		None	None			1						1	Bedridden; Chills; Hypersensitivity; Injection site mass; Injection site swelling; Pyrexia	FLU3~SANOFI PASTEUR~U2512AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0962U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0298960	12/06/2007	OH	12.0	12		F	11/27/2007	Syncope with questionable brief (seconds) seizure that resolved in 10-15 seconds total. Patient rested in office for 15-20 min and drank some water. Had normal vital signs after event. She passed out 15 min after injection.									Y	11/21/2007	11/21/2007	0		PVT	PVT	Multivitamin	None	None			1						1	Convulsion; Loss of consciousness; Syncope	FLUN3~MEDIMMUNE VACCINES, INC.~500492P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~15224~2~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0298961	12/06/2007	WI	16.0	16		F	11/26/2007	11/23 1 wk of itching rash started <24 hours after immunizations, tried Xyzal for itch (papular rash).  11/26 No success with Xyzal, changed to Prednisone 40mg BID tapered close for 10 days (papular firm rash) not hives.									Y	11/15/2007	11/16/2007	1	None	PVT	PVT	None		NKA			1						1	Induration; Rash papular; Rash pruritic	FLU3~SANOFI PASTEUR~U2479AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1265U~1~IM~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2426AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0298962	12/06/2007	IL	65.0	65		F	11/15/2007	Patient was in severe pain at sight worsened overnight, patient went to hospital and was given a shot for pain.				Y					Y	10/27/2007	10/28/2007	1		OTH	PVT	Citalopram, Propranolol					1						1	Injection site pain	FLU3~SANOFI PASTEUR~U2514AA~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1132U~1~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0298966	12/06/2007	NY	89.0	89		F	11/29/2007	Patient presented at ER with c/o SOB and hives. She stated she started having hives/vasculitis afternoon 11/27-Now processed large areas of vasculitis, legs back, arms. Large local reaction (L) upper arm.				Y					Y	11/27/2007	11/28/2007	1	X-ray, temp 98.8, RR 22, HR 95, BP 153/78, O2 Sat 93%, RA	PUB	PVT	Aricept; Pravachol; Aspirin; Nexium; Toprol; Seroquel	A-Fib; pneumonia; Kidney; HTN; anemia	NKDA			1						1	Blood pressure; Body temperature increased; Dyspnoea; Heart rate; Local reaction; Oxygen saturation normal; Respiratory rate increased; Rheumatoid factor; Urticaria; Vasculitis; X-ray	FLU3~SANOFI PASTEUR~12441AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1347U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0298967	12/06/2007	WI	85.0	85		F	11/14/2007	Had significant pain in arm 1st few days after vaccine administered. Pain continues like dull tooth ache deep down to bone intermittently and when present affects ability to raise arm (right). She was instructed to see MD				Y					N	10/17/2007	10/17/2007	0	To use heat or ice 3-4 x 1 day No marks, redness, swelling, nodules	OTH	UNK		None				1						1	Hypokinesia; Injected limb mobility decreased; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80062~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0298968	12/06/2007	AR	8.0	8		F	12/03/2007	On 10/18/07 around noon she started feeling bad - headache, runny nose, fever. Went to bed around 11:00 PM. Woke me (mother) up yelling. She was hallucinating, very frightened and agitated. Thought her room was torn up and seeing pieces of stuff floating everywhere. Felt very hot (fever). This went on for about 4 hours.									Y	10/16/2007	10/19/2007	3		OTH	OTH	None	None	Eczema (mild)			1						1	Agitation; Hallucination; Headache; Malaise; Pyrexia; Rhinorrhoea; Screaming; Skin warm	FLUN3~MEDIMMUNE VACCINES, INC.~500479P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0298969	12/06/2007	NH	3.0	3		M	11/21/2007	Child given Flumist into (L) nose with difficulty. Become upset and blew his nose, then second part of Flumist given (R) nose. Had nose bleed for (R) side. Given Kleenex. Spoke to mom about pressure on (R) side of nose.									Y	11/21/2007	11/21/2007	0		PUB	UNK		Cold; Stuffy Nose	NKA			1						1	Epistaxis; Irritability; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~500482P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0298970	12/06/2007	NY	27.0	27		F	11/21/2007	Pt was clothing shopping with mom and fiance. She was trying on clothes and c/o severe throbbing pain (L) elbow to wrist at 1 PM. Was given Advil and went home to ice arm.									Y	11/21/2007	11/21/2007	0		PUB	PUB	Birth control	None	None			1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2526AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298971	12/06/2007	VA	44.0	44		F	12/06/2007	Tingling and numbness to fingers and feet.									Y	11/15/2007	11/17/2007	2	Neurologic evaluation	PVT	UNK		N/A	N/A			1						1	Hypoaesthesia; Neurological examination; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81110~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0298973	12/06/2007	OR	44.0	44		F	11/15/2007	Broke out in hives, couldn't breathe (SOB) 1 hr after administration (imbilatory transfer to hospital for admin 515 PM.				Y					Y	11/13/2007	11/13/2007	0		PUB	OTH	Singulair; Effexor - antidepressants; Requip - RLS	N/A	Fibromyalgia		OR200749	1						1	Dyspnoea; Urticaria	FLU3~SANOFI PASTEUR~U2512AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298974	12/06/2007	CA	14.0			M	12/06/2007	Received vaccine on 12/3.  Developed T to 100-101 with emesis, nausea, diarrhea.  Fever X2D, diarrhea X3D.  Still with nausea, diarrhea, general feeling of fatigue & weakness.  Neurol normal.									U				None	PUB	OTH		None	Poland anomaly, food allergy (being evaluated)			1						1	Asthenia; Diarrhoea; Fatigue; Nausea; Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500490P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U2420AA~1~UN~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~1354U~2~UN~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0298975	12/06/2007	PA	30.0	30		F	12/06/2007	At approximately 4:50 pm immediately after flu shot given, patient complained of throat was tightening and was dizzy.  Gave as prescribed CPI injection to left thigh.  Patient stated she felt completely normal.  Refused to go with paramedics to ER.  Patient called office 12/6/07 to report no symptoms of anophylaxis.									Y	12/06/2007	12/06/2007	0	N/A	UNK	PVT	Prozac, Prilosec	None	Patient has history of depression, on Prozac.			1						1	Dizziness; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA32AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0298977	12/06/2007	OR	35.0	35		F	11/16/2007	Approx 12 hours after shot was administered I experienced intense nausea, shakiness, and aches.  These symptoms lasted for approx 24 hour, not resulting in any vomiting.  Weakness and some tenderness around injection site still remains 48 hours after shot.									Y	11/14/2007	11/14/2007	0		PUB	PUB		None	None		OR200750	1						1	Asthenia; Injection site pain; Nausea; Pain; Tremor	FLU3~SANOFI PASTEUR~U2512AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298980	12/06/2007	MI	32.0	32		F	12/04/2007	Developed 2-3 cm local reaction at injection site following day.  The rash at side that continued over the body.  Tried Benadryl, was given Prednisone at doc. visit.				Y					Y	11/29/2007	11/30/2007	1		PVT	PVT		None				1						1	Injection site reaction; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80073~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0298981	12/06/2007	OH	61.0	61		F	12/04/2007	Gave patient shot in (L) deltoid. Upon pressing plunger, influenza squirted out of syringe all over patient and myself. Retracted syringe and regave new dose with new syringe in (R) deltoid. Pt came to me 12-4-07, states sores in area where vaccinated x 2 days then 7 days later muscle weakness, aches in both arms (shoulder to elbow, no fault). Lasted until MD visit 12-3-07 and was prescribed Naproxen and better but not gone.				Y					N	11/02/2007	11/09/2007	7	N/A	OTH	OTH	Lipitor; Synthroid; Naproxen	N/A	High cholesterol, Low thyroid			1						1	Medical device complication; Muscular weakness; Myalgia; Underdose	FLU3~SANOFI PASTEUR~U2523AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0298985	12/06/2007	MT	67.0	67		F	12/06/2007	Next day: chills, achiness, headache, fatigue. Very sore arm, swelling of arm. 12-1-07 Arm still very sore and inflamed-swollen and 2 large red splotches. Went to doctor at medical center-Blood tests, taken, Prescribed Amoxicillin for 10 days.				Y					N	11/28/2007	11/29/2007	1	Visual; Blood tests	PUB	OTH	None	None	None			1						1	Blood test; Chills; Fatigue; Headache; Inflammation; Oedema peripheral; Pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0298987	12/06/2007	MA	8.0	8		M	12/06/2007	Raised red area very pruritic/raised similar to urticarial wheal. Better after ice applied.									Y	11/29/2007	11/30/2007	1	None	PVT	PVT		None	None			1						1	Erythema; Pruritus; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500480P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~1247U~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0298919	12/07/2007	CA	31.0	31		F	12/06/2007	Pt was given her 4th Anthrax vaccine one month early and was incorrectly administered distal to the deltoid. Also pt recieved the FLU vaccine on the same day. As a result on the following day, the patient c/o of flu like symptoms with fever, bodyaches, fatigue, abnormal swelling and redness in L arm from Anthrax vaccination.									Y	12/05/2007	12/06/2007	1	Physical Examination	MIL	MIL		None				1						1	Erythema; Fatigue; Incorrect route of drug administration; Influenza like illness; Pain; Pyrexia; Swelling	ANTH~EMERGENT BIOSOLUTIONS~FAV173~4~SC~RA~ANTHRAX (BIOTHRAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA049AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0298972	12/07/2007	NH	44.0	44		M	12/02/2007	Body aches and pain (skeletal and muscular soreness).  Elevated temperature, low energy level, headaches, nasal congestion, sore throat.									Y	11/04/2007	11/08/2007	4		MIL	MIL		N/A	N/A			1						1	Asthenia; Body temperature increased; Bone pain; Headache; Myalgia; Nasal congestion; Pain; Pharyngolaryngeal pain	ANTH~UNKNOWN MANUFACTURER~FAV111~2~SC~LA~ANTHRAX (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA049AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0299044	12/07/2007	TX	7.0	7		M	12/07/2007	Had Intranasal Flu vaccine at around 2:00 p.m. and went back to school, after receiving 2 tsp. Ibuprofen syrup.  Mother brought him back about 4 p.m. saying he got off the bus itching and with hives on neck, chest, abdomen, back, no difficulty breathing.  We gave him Zyrtec 7.5 ml. and kept him about 40 minutes.  He developed no further symptoms but remained with hives.  Sent him home with Benadryl chewable tablets to take at bedtime for hives. Called mother this morning, she said he was fine, hives were gone by time they got home yesterday.									Y	12/06/2007	12/06/2007	0		UNK	PUB	Ibuprofen syrup 2 tsp., Zyrtec 7.5 ml.	None	Seasonal allergies, history of hives	unknown~ ()~NULL~~In Patient|unknown~ ()~NULL~~In Sibling1|unknown~ ()~NULL~~In Sibling2		1						1	Condition aggravated; Pruritus; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~5004908~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0299048	12/07/2007	FL	55.0	55		F	12/07/2007	Client went to see physician this AM.  when he started having symptoms of ringing in ears and dry mouth, and feeling achy early this AM.  At that time his left arm and axillary area started swelling and became hot to touch. He received Toredol IM for pain and was sent home with an RX for Toredol.				Y					U	12/06/2007	12/07/2007	1		PUB	PVT						1						1	Dry mouth; Oedema peripheral; Pain; Skin warm; Tinnitus	FLU3~SANOFI PASTEUR~U2527AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1175F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0299052	12/07/2007	PA	4.0	4		F	12/07/2007	entire left upper arm is red after the vaccine was given (12/4/07) with darker red area where it was more swollen yesterday.  Immunization site noted in center of the erythematous area. Given Benadryl by mother. Advised cold compresses.									U	12/04/2007	12/04/2007	0		PVT	PUB	Strattera, Seroquel	None	ADHD, Behavior problems, Fetal Toxin exposure	None~ ()~NULL~~In Patient		1						1	Injection site erythema; Injection site swelling; Oedema peripheral	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B124BA~4~IM~LA~DTAP + HEPB + IPV (PEDIARIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500490P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB218AA~2~IM~RA~HEP A (HAVRIX)~1|MMRV~MERCK & CO. INC.~0617U~1~SC~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0299053	12/07/2007	VA	23.0	23		F	12/07/2007	Patient exhibited hives difficulty breathing and felt like her throat was closing up greater than a hour after receiving vaccinations. Pt went to facility and recieved Benadryl, Solumedrol and epinephrine and albuterol nebulizer and IV Fluids.				Y					Y	12/07/2007	12/07/2007	0		MIL	MIL						1						1	Dyspnoea; Throat tightness; Urticaria; Cough; Dyspnoea; Pharyngeal oedema; Pruritus; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500502P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB107BA~3~IM~RA~HEP A + HEP B (TWINRIX)~1|YF~SANOFI PASTEUR~UE912AA~1~SC~LA~YELLOW FEVER (YF-VAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500502P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB094AA~1~IM~RA~HEP A + HEP B (TWINRIX)~3|YF~SANOFI PASTEUR~UE912AA~1~IM~LA~YELLOW FEVER (YF-VAX)~3	USA	Emergency room visit	Influenza
0299054	12/07/2007	MI	40.0	40		F	12/07/2007	throat swelled hard to breathe,I was rushed  to the hospital and on route to the hospital I was given a shot and in the hospital I was given another shot to stop and prevent any further swelling of my throat			Y	Y					Y	11/02/2007	11/02/2007	0	anaphylaxis,the paper work I recieved from the hospital states I reacted to a preservative or carrier in the flu shot	UNK	PVT		none	allergic to iodine,asthma			1						1	Anaphylactic reaction; Dyspnoea; Pharyngeal oedema	FLUX~UNKNOWN MANUFACTURER~00000~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0299055	12/07/2007	MI	13.0	13		F	12/07/2007	DTap administered inadvertently as adolescent dose of tetanus/diphtheria/pertussis vaccine (instead of Tdap). No known adverse event associated as of 12/7/2007.										12/05/2007				PUB	UNK						1						1	Medication error; Wrong drug administered	DTAP~SANOFI PASTEUR~C2651AA~6~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2511AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0927U~1~IM~RA~HPV (GARDASIL)~1	USA		Influenza
0299092	12/07/2007	AZ	35.0	35		M	12/07/2007	Pain, Ecchymosis at injection site-occ. Tingling- (L) middle finger									N	11/19/2007	11/26/2007	7		PVT	PVT		None	None			1						1	Injection site haemorrhage; Injection site pain; Paraesthesia	FLU3~SANOFI PASTEUR~U2515AA~1~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299093	12/07/2007	ND	0.52	0	.5	M	12/05/2007	on 11/22/07 increased fussiness and decreased movement of (L) extremities <24 hr after; immunization. Symptoms persisted >48 hr resulting in ER visit and evaluation on 11/24/07 of - MRI an that date revealed (R) hemisphere MCA stroke.  12/18/2007 D/C summary received in addition to MR received yesterday for DOS 11/24-12/12/2007 with D/C DX: Acute middle cerebral artery infarct and stroke, etiology thought to be thrombotic. Left hemiparesis.   Infant presented to ER on 11/24/2007 after parents noted pt was not moving L side of body.  Pt had been fussy and running a fever since the morning following vax.  Pt was seen on 11/23/07 by PCP, but sx had improved and no significant neurological impairment noted other than decreased strength in RUE.  Pt brought to ER with abnormal looking smile.  Asymmetry noted on PE with L sided weakness.  Decreased tone and spontaneous movement on L side.  On assessment stroke is gauged to be 2 or more days old and possibly clinically improving.  Repiratory difficulty/apnea noted and pt intubated. Extubated 12/1/07. No eveidence of seizures. Consults by neurology, physical med & rehab, pediatric hematology. Txd with Lovenox.  D/C on ASA and Lovenox. 1/15/2010 Patient still has sequelae from adverse event and physician believes he always will. Patient is able to use left side and appendages but reports they are weaker and slower than right side.			Y	Y	Y	18			N	11/21/2007	11/22/2007	1	Brain CT; MRI's. Blood coagulation studies. Labs and Diagnostics:  MRIs (multiple) brain showed blockage of the R middle cerebral artery and ischemic stroke. Petechial hemorrhage noted 12/3/07. MRA showed above blockage with involvement of the R frontotemporal and parietal lobes, as well as R basal ganglia.  Echocardiogram normal. CXR with minimal new L basilar atelectasis.  EEG abnormal.  CT brain (multiple) show R middle cerebral artery infarct. Petechial hemorrhage note 11/30/07.  PT 9.8.  PTT 26.7 INR 1.0.  fibrinogen 354.  Factor V Leiden (-). Homocysteine low at 2.  Urine tox screen (+) for benzodiazapines. ANA (-). Magnesium level 2.7.  organic Acids and amino Acid testing WNL. CBC WNL.  Chemistry with AST 66, ALT 39, glucose 140, creatinine<0.2. 1/15/2010 Patient still has sequelae from adverse event and physician believes he always will. Patient is able to use left side and appendages but reports they are much weaker and slower than right side.	PVT	PUB	PRN OTC - Mylicon gas drops	None	None Healthy as newborn. PMH: newborn physiological jaundice.  NKDA.		ND0717	1						1	Blood creatinine decreased; Cerebrovascular accident; Coagulation test; Hypokinesia; Irritability; Scan brain	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B125AB~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT247DA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B54013D~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0770U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Life Threatening,Hospitalisation	Influenza
0299094	12/07/2007	PA	1.0	1	.0	M	12/07/2007	2x3 cm area erythema and induration of right lower thigh at site of Varivax administration. Tx analgesic prn.									Y	11/20/2007	11/27/2007	7		PVT	PVT			GER, Preterm 35 wk EGA, Kleinfelters Syn.			1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U2469AA~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB200AA~1~UN~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0809U~1~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~13586~1~UN~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0299095	12/07/2007	VA	41.0	41		M	12/07/2007	Developed Bell's Palsy 3 weeks after receipt of the inactivated influenza vaccine.  12/28/07 Reviewed medical records which reveal patient experienced left facial weakness, left eye tearing & left facial droop 11/11/07, 3 wks s/p flu vax.  Saw pcp on 11/13 for sinusitis then later tx w/antiviral & steroids. Returned to clinic 12/3 w/dry cough x 2 wks & was dx w/acute ethmoidal sinusitis.  FINAL DX: Bell's palsy.				Y					N	10/22/2007	11/11/2007	20	None; sxs resolving	OTH	PUB	None at time of vaccination	None	None PMH: URI s/s of sinus pressure, post nasal drip, rhinitis & HA x 2 wks.			1						1	Facial palsy	FLUX~UNKNOWN MANUFACTURER~~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0299098	12/07/2007	MT	60.0	60		F		(L) arm redness 4 cm patch				Y					N	11/13/2007	11/13/2007	0	No	OTH	PVT	None	No	Latex-sensitivity-oral cold sores			1						1	Erythema	FLU3~SANOFI PASTEUR~U2453AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299100	12/07/2007	NC	5.0	5		F	12/03/2007	Patients mother took child to Urgent Care 11-17-07 for limping - redness to site of vaccines. They measured a 5 x 2 1/2 reddened area to (L) anterior mid thigh. Injections given 1 1/2 measured apart sites.				Y					Y	11/15/2007	11/17/2007	2	None	PVT	PVT		None	None			1						1	Gait disturbance; Injection site erythema	FLU3~SANOFI PASTEUR~U2478DA~4~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~09630~1~UN~LL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0299101	12/07/2007	TX	54.0	54		F	11/28/2007	About 6 hours after the shot I began vomiting and had the chills-bad. This lasted all night and into following day									Y	11/27/2007	11/27/2007	0		OTH	OTH	None	None	None			1						1	Chills; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA029AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0299102	12/07/2007	NH	3.0	3		M	11/13/2007	On 11-10-07 at 700 AM mother noted swelling, redness and tenderness at injection site. On 11-11-07 the area had increased in diameter with slight bruising in the center. On 11-12-07 entire thigh was swollen, reddened and itchy. Seen by PCP on 11-12-07 who diagnosed this as an allergic reaction and prescribed Benadryl.				Y						11/09/2007	11/10/2007	1	None	PUB	PUB	Pulmicort; Singulair	Mild runny nose	Being evaluated for asthma	Mild local reaction~Influenza (Seasonal) (no brand name)~1~2.00~In Patient		1						1	Hypersensitivity; Injection site bruising; Injection site erythema; Injection site pain; Injection site pruritus; Injection site swelling; Oedema peripheral	FLU3~SANOFI PASTEUR~U2475JA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299104	12/07/2007	NY	40.0	40		F	11/30/2007	2006 flu shot mistakenly administered (instead of 2007 shot). Lips, eyes, face swelled. Required adult dose of antihistamine. Mild swelling of eyelids continued into next day.									Y	10/17/2007	10/17/2007	0		PVT	UNK		None	Ragweed, cats			1						1	Expired drug administered; Eyelid oedema; Lip swelling; Swelling face	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0299105	12/07/2007	TX	0.5	0	.5	M	12/03/2007	Hives and swelling of injection site (R) thigh and (L) thigh. Given Benadryl 3 ml q 7 hours PRN.									Y	11/30/2007	12/01/2007	1		PVT	PVT						1						1	Injection site swelling; Injection site urticaria	DTAP~SANOFI PASTEUR~C2760AA~3~UN~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2473GA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~UNKNOWN MANUFACTURER~UF208AB~3~UN~LL~HIB (NO BRAND NAME)~1|IPV~SANOFI PASTEUR~A0273~3~UN~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~B08702K~3~UN~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0299106	12/07/2007	CA	2.0			M	12/03/2007	Pt was given 0.5 ml Fluzone regular instead of 0.25 ml Fluzone with preservative. No adverse event.														PVT	PUB		None	None			1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~U2443AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299107	12/07/2007	CA	69.0	69		F	11/22/2007	Patient noted within 1 week developed numbness and waves of burning, stinging pain down arm into left thumb.  Mild redness that comes and goes.  No papules or blisters.  Over this last week, less frequent episodes.  Mild tenderness at base of nail.										10/16/2007	10/23/2007	7	None - exam only - normal	PVT	PVT	Travatan - eye drops, Lotemax - eye drops	Glaucoma	Glaucoma, osteopenia			1						1	Burning sensation; Erythema; Hypoaesthesia; Pain in extremity; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~79241~UNK~IM~~INFLUENZA (SEASONAL) (FLULAVAL)~1|VARZOS~MERCK & CO. INC.~08864~1~~~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0299110	12/07/2007	NH	4.0	4		M	12/07/2007	pt developed rash-Hives approximately 5 hours following vaccination. Approx. 36 hours following vaccination rash progressed and pt developed swelling of face and hands. Rash resolved day 5 following vaccination. Tx w/Benadryl				Y					Y	11/30/2007	11/30/2007	0	None	PVT	PUB	None		Zithromax			1						1	Oedema peripheral; Rash; Swelling face; Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14049AA~5~UN~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2457DA~4~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0872~4~UN~LA~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0299067	12/08/2007	OH	4.0	4		F	12/08/2007	Swollen watery eyes, runny nose, chest congestion, fever 102.2 Sleeplessness, Crying uncontrollably for short periods of time. My child had the vaccines on a Tue. and was very sick by Thursday evening. Today is Sat. and my child is feeling somewhat better without fever but continues to be congested.									Y	12/04/2007	12/06/2007	2		PVT	PVT	Daily children's multivitamin	None	None	Rash, fever, general malaise~Measles + Mumps + Rubella (no brand name)~1~2.30~In Patient		1						1	Crying; Eye swelling; Insomnia; Lacrimation increased; Pyrexia; Respiratory tract congestion; Rhinorrhoea	DPP~UNKNOWN MANUFACTURER~~5~IM~UN~DIPHTHERIA TOXOID + PERTUSSIS + IPV (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~2~IN~NS~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~1~UN~UN~HEP A (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~2~SC~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~UN~PNEUMO (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~2~SC~UN~VARICELLA (NO BRAND NAME)~1	USA		Influenza
0299069	12/08/2007	IN	38.0	38		F	12/08/2007	Within one week of vaccination--numbness to right side of face, throat, progressed to right arm, right leg and left leg within a few days. Had right sided headache, and became dizzy and ataxic.  Symptoms have slowly resolved over approximately 1 month, with residual right leg weakness and intermittent headache.  12/28/07 Reviewed pcp medical records which reveal patient experienced numbness of right side, numbness & tingling of right hand/arm, HA,  difficulty walking.  Improved w/steroids. No neuro consult done. FINAL DX: limited right polyneuropathy.				Y					U	10/31/2007	11/07/2007	7	MRI with contrast, CBC, BMP, Sed rate, TSH, LABS: CBC, chemistry. sed rate & MRI of brain all WNL.	UNK	UNK	None	None	None			1						1	Ataxia; Blood thyroid stimulating hormone; Dizziness; Headache; Hypoaesthesia; Hypoaesthesia facial	FLU3~PFIZER\WYETH~80682~1~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA	Emergency room visit	Influenza
0299070	12/08/2007	GA	0.2	0	.2	F	12/08/2007	On Friday, November 16, I requested a flu shot on a routine office visit.(my fourth year)The vaccine information statement notes that it is Inactivated Influenza Vaccine. For the next week, I had some pain/discomfort in my upper left arm.On Thursday evening, November 29, stabbing/jabbing pain in my left upper arm awakened me and I could not turn over. I took two extra strenth tylenol, rubbed flex-all 454 on my arm and went to work Friday. I could not lift my left arm at work. Upon returning home from work, I started having chills and cold/hot. I crawled up on the couch, I asked my son to get some advil so I could treat the pain with extra strength tylenol or inflamation with ibuprofen.This stabbing/jabbing/throbbing pain continued Saturday and Sunday.On Saturday, December 1, I called facility and an advice nurse called me back. I told her about the stabbing/jabbing pain, She asked if I had a elevated temp., I told her no. I told her how I was treating this pain. She said if it did not subside to come to urgent care at the Southwood facility.I used two absorpbine, jr. heating pads The pain decreased, the stiffness, range and motion was slow to return and Friday of this week, December 7, was my best day for movement, lifting my left arm. It has been a challenge getting dressed, especially putting on my bra. This has been a most physically painful experience.									Y	11/16/1945	11/29/2007	22658		UNK	UNK		none	none			1						1	Chills; Feeling of body temperature change; Injected limb mobility decreased; Musculoskeletal stiffness; Pain in extremity; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0299072	12/08/2007	FL	67.0	67		F	12/08/2007	Within twelve hours after patient received vaccinations for FLU and PNEUMONIA simultaneouly, she suffered naso/pharyngeal inflamation and loss of speech and general malaise and weakness. She received medical care from her primary care physician who prescribed prednisone therapy.				Y					N	11/29/2007	11/30/2007	1		UNK	UNK		no illness at time of vaccinations	Type 2 diabetic on oral medication which controls A1C levels.			1						1	Aphasia; Asthenia; Malaise; Nasopharyngitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0299073	12/09/2007	VA	57.0	57		M	12/09/2007	Two days after getting the flu shot, I started to feel sick with flu like symptoms. On Saturday and Sunday (20 -21 October 07) I was weak and started a mild cough and spent the weekend resting.  For the next week, in the mornings I felt ok, but by early afternoon was weak, tired coughing, and ended up going home from work early on a number of days.  On the following weekend I was so sick I stayed in bed resting.  On 30 October, at about 0900 hrs the left side of my head started hurting so bad I called for an immediate doctor's appointment.  I went in at 1400 hrs.  I was examined by Dr. and she ordered a chest x-ray and prescribed a two week regiment of antibiotics to combat a sinus infection.  After about three days on the drugs I started to feel better but continued to be weak and tired and had a strong cough.  On 28 November, I went back to the doctor and was examined by Dr. who put me on a five day regiment of antibiotics, and ordered another chest x-ray to insure I did not have pneumonia.    As of today, 9 Dec 07, I feel almost normal.  I believe the treatment from my doctors to be excellent.  However, I believe my six plus week illness to be directly related to the flu shot I received.									Y	10/17/2007	10/19/2007	2		UNK	UNK		None	I am currently on coumidin.			1						1	Activities of daily living impaired; Asthenia; Chest X-ray; Cough; Fatigue; Headache; Influenza like illness; Malaise; Sinusitis	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0299075	12/09/2007	MA	62.0	62		M	12/09/2007	4 DAYS, 6 HRS. AFTER FLU VACCINE, I SUDDENLY HAD CHILLS AND SHIVERING. I WENT TO BED AND FELL ASLEEP; WOKE UP IN THE MIDDLE OF THE NIGHT FEELING HOT AND HAD STIFF AND TIRED MUSCLES. AT THIS TIME, I TOOK MY TEMPERATURE AND FOUND IT TO BE 101.5.  I STAYED IN BED FOR A TOTAL OF 19 HRS. AT WHICH TIME MY TEMPERATURE WAS 99.  AFTER GETTING UP I FELT PRETTY MUCH NORMAL BUT I STILL HAD STIFF MUSCLES, A LIGHT HEAD AND SHOOTING PAINS IN MY HEAD, EARS. AND FACE.  WHILE IN BED I WAS ASLEEP NEARLY THE ENTIRE TIME.  AT HIS TIME (ABOUT 40 HRS. AFTER THE INITIAL CHILLS) I FEEL NORMAL.										12/03/2007	12/07/2007	4		PUB	UNK						1						1	Body temperature increased; Chills; Dizziness; Ear pain; Facial pain; Feeling hot; Headache; Hypersomnia; Muscle fatigue; Musculoskeletal stiffness; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0297815	12/10/2007	CT	3.0	3		F	12/05/2007	Seriousness criteria: Other-Medically significant A three-year-old female patient, with no repeated medical history, received a left arm intramuscular injection of Fluzone (lot number U2465AA) on 15 November 2007. Approximately five hours later, she developed toxic synovitis, and was seen in the emergency department where she was treated with pain medication. She was still experiencing toxic synovitis the following day, and prescribed to the emergency department again where she was treated with additional pain medications. On 17 November 2007 she developed intussusception, which was successfully reduced with an air enema. The reporter considered the events to be resolved.				Y					Y	11/15/2007	11/15/2007	0		PVT	PVT			No illness at time of vaccination; no pre-existing medical conditions reported.		200704002	1						2	Enema administration; Intussusception; Synovitis; Enema administration; Intussusception; Synovitis	FLU3~SANOFI PASTEUR~U2465AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2465A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0299078	12/10/2007	CA	40.0	40		U	12/10/2007	Allergic reaction within 20 minutes went to ER. Treated then back to the ER several times then admitted to the hospital for two days. Treatedd with 125 mg. Prednisone IV and zantac and bendryl. Ended up back at ER and admitted again for two days Tremors horrible headache treated with antibiotic had spinal tap done. Still Having allergic reaction 10 weeks later. Still on prednisone bendryl and zantac. Still having allergic reation. Red burning face itching, swollen neck face and throat. Tremors still, and cant swallow sometimes, blurry vision. I was given the HPV Vaccine by accident then given the flu shot right after. I was supposed two have the flu shot only.  12/28/07 Reviewed hospital ER medical records of 10/2/2007 which reveal patient experienced facial swelling, redness, itchy skin, dizziness, anxiety & dyspnea x 1 day.  Tx w/steroids & antihistamine.  Improved & d/c to home. FINAL DX: allergic reaction w/angioedema & bronchospasm, secondary to drug.				Y	Y	4			U	10/01/2007	10/01/2007	0	lab, spinal tap. X-rays	UNK	UNK	Prevacid   30 mg 2x day  Prednisone  6 mg. daily  Clarinex   Metformin 500 mg. 2x daily  Flexeril  10 mg. PRN    Clonazepam 0.5 mg. 2x daily  Neurontin 300 mg  3 x daily Methotrexate   20 mg.   weekly      Zantac  150 mg.  2x daily    Potas	Diabetes, Rhuematoid arthritis, Sjogrens, Fibromyalgia, High Blood pressure, acid refux, hital hernia	Diabetes, Rhuematoid arthritis, Sjogrens, Fibromyalgia, High blood pressure, acid reflux, hital hernia. scoliosis, I was getting ready to have neck surgery. Allergies Iodine, betadine, Sulfa, Augmentin, Keflex, cipro,Glucotrol, Bextra, Plaquenil, Hydrochlorothiazide,Clindomyacin, vancomyacin PMH: HTN. DM, multiple prior allergic reactions w/hives, angioedema & wheezing secondary to meds & foods.  Hay fever.  RA.  Sjogrens disease.  Scoliosis.			1						1	Burning sensation; Dysphagia; Erythema; Headache; Hypersensitivity; Laboratory test; Local swelling; Lumbar puncture; Pruritus; Swelling face; Tremor; Vision blurred; Wrong drug administered; X-ray	FLUX~UNKNOWN MANUFACTURER~unknown~2~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~unknown~2~UN~LA~HPV (GARDASIL)~1	USA	Hospitalisation	Influenza
0299079	12/10/2007	CA	19.0	19		F	12/10/2007	Allergic Reaction red face swollen neck and face tight throat itcing, throat closing, hives. Face turned red and hot next day at work. Three days later throat closing, face red, couldn't swallow. Went to the ER. Prednisone zantac benadryl. When I went off prednisone I went back into allergy attack, my PA I see put me back on prednisone. Went to the ER once more. I am still having the same symptoms just not as often. It has been 10 weeks since the injections.				Y					N	10/01/2007	10/02/2007	1	none treated for reaction	PVT	PVT	clarinex, motrin, zantac, benadryl	None	Pennicillin, zithromax, red food dye,			1						1	Dysphagia; Erythema; Hypersensitivity; Local swelling; Skin tightness; Skin warm; Swelling; Throat irritation; Throat tightness; Urticaria; Dyspnoea; Erythema; Pruritus generalised	FLUX~UNKNOWN MANUFACTURER~unknown~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~unknown~2~IM~RA~HPV (GARDASIL)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HPV4~MERCK & CO. INC.~0188U~UNK~IM~UN~HPV (GARDASIL)~2	USA	Emergency room visit	Influenza
0299081	12/10/2007					M	12/07/2007	This case was reported by a healthcare professional, via sales representative, and described the occurrence of Guillain Barre syndrome in a male subject of unspecified age who was vaccinated with influenza vaccine trivalent (Flulaval, GlaxoSmithKline) for prophylaxis. Medical history and concurrent conditions were unknown.  It was also unknown if the subject had experienced any adverse events following previous vaccinations.  In November 2007 the subject received 1st dose of Flulaval (unknown).  At an unspecified time after vaccination with Flulaval, the subject developed Guillain Barre syndrome which was reported to include paralysis.  It was reported that the paralysis occurred approximately five minutes after vaccination with Flulaval.  The subject was hospitalized and his status was unknown.  The reporter considered that the events were disabling.  At the time of reporting the outcome of the events was unspecified.  The reporter considered that the Guillain Barre syndrome was unrelated to Flulaval.					Y	0		Y	U	11/01/2007	11/01/2007	0	UNK	OTH	OTH		Unknown	Relevant medical history, concurrent medications and adverse events following previous vaccinations were unknown.		A0697970A	1						1	Guillain-Barre syndrome; Paralysis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation,Disabling	Influenza
0299089	12/10/2007	MN	6.0	5		F	12/07/2007	Redness/swelling approx 10 cm in diameter, on left thigh.									Y	12/05/2007	12/05/2007	0		PVT	PVT		None	None			1						1	Erythema; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80686~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0299113	12/10/2007	KS		66		F	12/10/2007	Later the day of vaccination or early the next day patient had rash up arm of vaccination									Y	10/25/2007	10/25/2007	0		UNK	UNK						1						1	Injection site rash	FLU3~SANOFI PASTEUR~U2464AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299114	12/10/2007	MS	83.0	83		F	11/27/2007	PT HAD PNEU SHOT THURSDAY 11/8/07 SITE STARTED TURNING RED FRIDAY 11/9/07.  THIS WAS PT'S 2ND PNEU SHOT. PT HAD STATED AT TIME OF INJ THAT SHE HAD NOT HAD ONE.  PT'S ARM RED,WARM(NO SWELLING) ON INSIDE OF ARM TO ELBOW ALL WEEKEND. BETTER MON BUT CLINIC CLOSED. PT CALLED TUES AND WAS ASKED TO COME TO CLINIC. ARM STILL PINK BUT PT DENIES ANY PAIN ADVISED NOT TO GET ANOTHER PNEU SHOT									Y	11/08/2007	11/09/2007	1	NOE	PUB	PUB		NONE	NONE		MS07034	1						1	Erythema; Injection site erythema; Skin warm	FLU3~SANOFI PASTEUR~U2445A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0554U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0299115	12/10/2007	OH	35.0	35		F	12/10/2007	soar throat,dizziness and fatigue,coughing,chest hurting in front in back when I coughed,									Y	11/21/2007	11/22/2007	1	I did not go to the doctor.I felt like I had the flu right after the flu shot but I took cold medicine thinking I just had a cold(alka seltzer cold).I took my son(age 12) to his pediactric doctor and they gave him a flu shot since he has asthma and when i looked at the paper of symptoms after a flu shot I seen all my symptoms there that I had previously had after my shot.	PUB	PUB	levoxtrine(synthroid),peroxitine(paxil),centrum multivitamins	Thyroid(hypo)	thyroid,depression			1						1	Chest pain; Cough; Dizziness; Fatigue; Pharyngolaryngeal pain	FLUX~UNKNOWN MANUFACTURER~~2~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0299118	12/10/2007	CA	1.0	1	.0	M	12/10/2007	7 hours after receiving 6 immunizations, patient had 3 minute generalized seizure witnessed by mother.  Transported by ambulance to ED where evaluation ensued and was negative after exam and blood work up. Diagnosis: Presumed febrile seizure.				Y					Y	11/30/2007	11/30/2007	0	Uine, serum electrolytes, glucose, CBC all reassuring.	UNK	PUB		Mild febrile illness with diarrhea for 7 days reported by mother.  Evaluated at our clinic 11-30-07, noted to be afebrile, playful, with normal exam, except preexisting <5 percentile weight.	Mild diarrheal illness X 7 days, <5 percentile body weight under evaluation.			1						1	Blood electrolytes normal; Blood glucose normal; Febrile convulsion; Full blood count normal; Urine analysis normal	FLUX~UNKNOWN MANUFACTURER~AVPU2490AA~2~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB182AA~1~IM~RL~HEP A (HAVRIX)~1|HIBV~MERCK & CO. INC.~MSD0676U~3~IM~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~MSD0289U~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~WYE870143H~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~MSD0731u~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0299120	12/10/2007	MN	65.0	65		F	12/10/2007	2-3 days p vaccine developed respiratory symptoms of cough, increased sputum , no T. on 11/14 seen by PA for symptoms. WBC 17,000. (Has hx of COPD, heavy smoker.)RX with antibiotic and prednisone. ON 11/19 seen for same symptoms plus weakness, shaky.  Similar had occurred years before related to her Cardizem, so dose decreased.  11/21-continued weakness, seen by HCP, no motor deficits, CT scan nl.  12/6 still weak and dizzy, comes and goes, consider Guillan-Barre, to have neuro consult. 12/13/07-records received for DOS 10/31-12/11/07-C/O feeling tired , cough congestion, weak and shaky. Legs feel weak.  Impression: probable viral illness improving. Has had significant workup for weakness and tremor which appear to be an intention tremor. Unknown etiology could be stress. On visit day of vaccine C/O numbness to feet, feel like asleep.				Y					U	10/30/2007	11/03/2007	4	11/19 WBC:  17,000  12/6 CT scan: normal 12/13/07-records received-CT head negative.	UNK	UNK	diabetic meds, cardizem, anitbiotics	none 12/13/07-records received-On visit day of vaccine C/O numbness to feet, feel like asleep.	Type II diabetes, allergy to codeine, COPD 12/13/07-records received-HX of Bell's Palsy several years ago. Emphysema. Smoker. Type II Diabetes. Hyperlipidemia.			1						1	Asthenia; Computerised tomogram normal; Cough; Dizziness; Productive cough; Tremor; White blood cell count increased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA029AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0299121	12/10/2007	CA	55.0	55		F	12/10/2007	Approximately 5 hours after shot, right leg began to hurt - like running into a piece of furniture.  For two days patient was completely debilitated like having a severe case of arthritis in right hip and leg.									Y	11/06/2007	11/06/2007	0		UNK	PVT						1						1	Arthralgia; Asthenia; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLAO82AA~2~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0299122	12/10/2007	MD	23.0	23		F	12/10/2007	LIGHTHEADED, FAINTNESS, WEAKNESS, NAUSEA, COLAPSING, DIZZINESS, LEG PAIN				Y					Y	12/08/2007	12/08/2007	0		MIL	MIL	DEPOPROVERA, PRENATALS, B-12 1000 MCG, CALCUIM 1000 IU, VITAMIN D 400 IU, IBUPROPHEN 800 MG, METHOCARBAMOL 500 MG, PERCOCET 5 EQ	LOWER BACK PAIN	DEGENERATIVE DISK DISEASE, HERNIATED DISKS, NURSING			1						1	Asthenia; Dizziness; Nausea; Pain in extremity; Syncope	FLUX~UNKNOWN MANUFACTURER~UNKNOWN~7+~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0299128	12/10/2007	TX	26.0	26		F	12/10/2007	States redness and induration at site of injection.  Severe migraine, body aches day after vaccination.  No temp noted 3 days after vaccination.									Y	12/07/2007	12/08/2007	1		PVT	UNK	Pt. also given PPD with tubersol same day as Influenza vaccine.	none				1						1	Injection site erythema; Injection site induration; Migraine; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA067AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0299148	12/10/2007	ID	76.0	76		F	12/07/2007	Information has been received from a 76 year old female with a history of chronic obstructive pulmonary disease and is allergic to codeine, who on 24-OCT-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unknown). Pneumococcal 23v polysaccharide vaccine (MSD), hepatitis B vaccine, recomb (MSD), Q-Bar 10 (manufacturer unknown), aspirin and analgesic or anesthetic (unspecified). On 25-OCT-2007 the patient felt weak. On 01-NOV-2007 the patient stated that she was completely in and out of it and would fall asleep without knowing it, but she would come to with sharp pains in joints. The patient stated that she may have had a fever. On 02-NOV-2007 and 03-NOV-2007 the patient experienced paralysis in shoulders arms. Her mouth was sore and everything tasted bitter. The patient stated that she became dehydrated because she couldn't lift her arm to drink water. On 04-NOV-2007 the patient went to the emergency room and she received pain pills. The patient stated that the physician said that she may have Guillian Barre. The patient stated that she was still relatively weak but her arms and mouth were doing better. The patient stated that she took 9 aspirin every day and that she was getting relief. No additional informtion was provided. There were no lab diagnostics studies performed. The outcome was reported as recovering. There was no product quality complaint. Upon internal review, Guillian Barre was considered to be an other medical event. Additional information has been requested.  12/12/2007 Vax record received from PCP with note from date of vax.  Info entered in VAERS database. 12/31/2007 MR received for ER visit 11/4/2007 with dx: likely adverse reaction from immunizations.  Pt presented with c/o generalized body aches and chills. Assessment:  Joint and muscle aches or myalgias and arthralgias 2' to complications s/p immunizations. Instructed to return to ER for further problems.  Spoke with pt 12/11/07 who stated she was not dxd with Guillain Barre.									N	10/24/2007	10/25/2007	1	None. Labs and Diagnostics: CBC unremarkable.  CMP with Cl- 95, glucose 142, Albumin 2.7 and ALT 58.	OTH	OTH	(therapy unspecified) analgesic or anesthetic; aspirin	drug hypersensitivity	chronic obstructive pulmonary disease. PMH:  COPD.  Allergies to Codeine and Sulfa.		WAES0711USA05794	1						1	Arthralgia; Asthenia; Dehydration; Dysgeusia; Oral pain; Pyrexia; Sleep disorder	FLU3~SANOFI PASTEUR~U2441AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0555U~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~0887U~UNK~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0299156	12/10/2007	OH				M	12/05/2007	This case was received from a health professional on 26 November 2007.  A male patient (age unspecified), with a history of gastrointestinal upset following egg consumption, received an intramuscular left deltoid injection of Fluzone (lot number U2527AA) on 19 November 2007.  Approximately 24 hours after vaccination, he complained of pain in both elbows.  On 21 November 2007, approximately 48 hours after vaccination, he developed a sore throat and mild, generalized muscle aches.  On 24 November 2007 he presented to the emergency department with pain and muscle spasms from his elbows to his fingertips, and decreased muscle strength in both arms.  Upon admission, his CPK was noted to be elevated at 2000 (units and reference ranges not provided).  Treatment included three doses of Benadryl, intravenous fluids, and cardiac monitoring.  The patient was discharged on 25 November 2007, at which time his symptoms were noted to be greatly improved.  Per the reporter, the patient had no other medical history, was not ill at the time of vaccination, and was not taking any concomitant medications.					Y	1			Y	11/19/2007	11/24/2007	5	24/Nov/2007: CPK 2000	PUB	PUB			eggs cause gastrointestinal upset		200704031	1						1	Arthralgia; Blood creatine phosphokinase increased; Muscle spasms; Muscular weakness; Myalgia; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U2527A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0299159	12/10/2007	PA	42.0	42		F	12/05/2007	Seriousness criteria: Other-Medically Significant Initial report received from a health care provider on 31 August 2007. A 42-year-old female patient with a medical history of a penicillin allergy, had received an intramuscular left deltoid injection of Fluzone SV 2007-2008, lot number U2436AA on 30 August 2007 and 15 minutes later, she complained of slight tightness in her throat. During assessment, the patients blood pressure was 120/80. The patient received corrective treatment with 25mg Benadryl administered orally five minutes after the event began. No further treatment was reported and the duration of the event had not been provided. The patient had received a prior dose of Fluzone in November 2006 however no information about prior adverse events after receipt of Fluzone had been provided. According to the reporter, the patient had recovered from the event. Follow-up information was received from the health professional on 26 November 2007. The patient's symptoms resolved within 15 to 20 minutes of Benadryl administration, and no additional treatment was necessary. No adverse events had been reported by the patient following previous dose of Fluzone. Per the reporter, the final diagnosis was anaphylactic reaction. Due to the information received in the follow-up report, this case has been upgraded to serious.				Y					Y	08/30/2007	08/30/2007	0	None reported	OTH	UNK			The patient was not receiving any concomitant medications and had no illness at the time of vaccination. The patient has a penicillin allergy but is able to take amoxicillin. No adverse effects reported with previous Fluzone injections.		200702998	1						1	Anaphylactic reaction; Throat tightness	FLU3~SANOFI PASTEUR~U2436AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299163	12/10/2007	WI	66.0	66		M	12/03/2007	Patient complains that left deltoid area was very painful at injection site at the time of injection. She states the area swelled up at the site and then bruised. The area is still bruised per patient who was not seen at this point.									Y	11/27/2007	11/27/2007	0		PVT	UNK		Hypothyroidism	Allergies: Sumatriptan, Niaspan, Lovastatin, Lescol			1						1	Injection site bruising; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2511AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299165	12/10/2007	IL	36.0	36		F	10/30/2007	10/27 Fever 104.5 Chills. Severe headache. SOB. Began 3-4 hr after Flu shot. Wen to Hospital Tx-O2 and IV. Sent home with Rx for Tylenol #3 ER physician stated was Rx to Flu vaccine.				Y					Y	10/27/2007	10/27/2007	0		PUB	PUB	None	None	None		MI2007027	1						1	Chills; Dyspnoea; Headache; Pyrexia	FLU3~SANOFI PASTEUR~U2505AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299168	12/10/2007	MI	70.0	70		F	10/23/2007	Vaccine given approximately 11:00 am on 10/18/07.  Tingling in right arm.  Complained of arm very sore but no redness or swelling - did apply ice when soreness started on 10/19/07 around 8:00 pm.  Fever high with chills, but had no thermometer to take temperature.  Fever broke around 11:00 pm 10/20/07 but appetite is down, feels sluggish, has aches (like pressure) across eyes.  No headache.  Soreness in arm resolving but has scheduled appointment with primary doctor on 10/25/07.									N	10/18/2007	10/19/2007	1		PUB	UNK		None	None		MI2007025	1						1	Abnormal sensation in eye; Decreased appetite; Limb discomfort; Pyrexia; Sluggishness	FLU3~SANOFI PASTEUR~U2488AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0061U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0299169	12/10/2007	DE	41.0	41		F	11/28/2007	Soreness in arm 26 days post injection									U	11/01/2007	11/02/2007	1		OTH	PVT		None				1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2457DA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299170	12/10/2007		21.0	21		F	11/28/2007	Received Flumist on 30 Oct 2007. Did not know she was pregnant.										10/30/2007			(+) HCG on 8 Nov 2007	MIL	MIL	Sertraline; Ortho Tricyclen	None	Dysthymic disorder; Depression			1						1	Blood human chorionic gonadotropin positive; Drug exposure during pregnancy	FLUN3~MEDIMMUNE VACCINES, INC.~500489P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0299171	12/10/2007		32.0	32		F	11/28/2007	Received Flu Mist on 30 Oct 2007.  Did not know she was pregnant.									U	10/30/2007			+ HCG on 13 Nov 2007	MIL	MIL	None	None	None			1						1	Drug exposure during pregnancy; Pregnancy test positive	FLUN3~MEDIMMUNE VACCINES, INC.~500489P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0299172	12/10/2007	NM				U		Given flu vaccine, Pneumovax in L arm 11/28.  On 11/29/07 came in with arm pain-improved, fever 101 degrees, myalgias.				Y					U	11/28/2007	11/28/2007	0		PVT	UNK		No	DM II, HTN, hyperlipidemia			1						1	Myalgia; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U2592AA~5~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1226U~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0299174	12/10/2007	MI	48.0	48		F	11/28/2007	Acute onset of 3-5mm raised red tender nodules with increased redness and swelling L lower leg - approx 6cm area - above ankle.  R lower leg few erythematous papules in same location but no swelling or tenderness.									Y	11/09/2007	11/11/2007	2	Questionable erythema nodosum	PVT	UNK	Albuterol, Flonase	No	Asthma			1						1	Erythema; Erythema nodosum; Oedema peripheral; Rash erythematous; Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80433~4~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0299175	12/10/2007	FL				F	11/06/2007	Severe sore arm and tender and sensitive to touch.									N	11/06/2007	11/06/2007	0		UNK	UNK						1						1	Hyperaesthesia; Pain in extremity; Tenderness	FLU3~SANOFI PASTEUR~U2513AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299176	12/10/2007	NV	80.0	80		M	12/05/2007	c/o malaise, myalgia, insomnia within 12 hrs of receiving vaccines.									U	12/04/2007	12/04/2007	0		PUB	UNK		None	None			1						1	Insomnia; Malaise; Myalgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA294FA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0889F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0299177	12/10/2007	NC	1.3	1	.3	F	12/04/2007	11/30 Febrile seizure 5 minutes, general WBC 12,400 56P 32L 9 ml EO 2A7 L4, BMP NL,  NA 140, CA 9.7, Urinalysis Normal 12/3/07 Follow up visit-Exam normal				Y					Y	11/20/2007	11/30/2007	10	WBC 12,400 56P 32L 9 ml EO 2A7 L4, BMP NL,  NA 140, CA 9.7, Urinalysis Normal	PVT	UNK		None	None			1						1	Blood sodium normal; Differential white blood cell count; Febrile convulsion; Metabolic function test normal; Urine analysis normal; White blood cell count increased; Blood test normal; Culture urine negative; Febrile convulsion	FLU3~SANOFI PASTEUR~UT2474AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1324F~1~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1338U~1~UN~LL~VARICELLA (VARIVAX)~1|MMR~MERCK & CO. INC.~~1~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~2|VARCEL~MERCK & CO. INC.~~1~UN~UN~VARICELLA (VARIVAX)~2	USA	Emergency room visit	Influenza
0299178	12/10/2007	LA	47.0	47		F	12/03/2007	Chest pain, fever, soreness in left chest area, swollen lymph gland, cold-like symptoms.				Y					Y	11/15/2007	11/27/2007	12	EKG, CXR	OTH	PUB	fluid pill	No	Anemia, hypertension	~Influenza (Seasonal) (no brand name)~UN~0.00~In Patient	LA071201	1						1	Chest X-ray; Chest pain; Electrocardiogram; Lymphadenopathy; Nasopharyngitis; Pyrexia	FLU3~SANOFI PASTEUR~U2614AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299183	12/10/2007	IL	2.0	2	.1	M	12/03/2007	Erythema surrounding injection site noted 1 day after administration. Fever, induration and spreading erythema on day 2. Blister formed seen in ED. Had blister unrooted. Wound culture sent. Culture results neg. Erythema and induration lessened by days 4-5. Fever, pain and irritable behavior also resolved.				Y					Y	11/27/2007	11/29/2007	2	wound culture negative	PVT	UNK	None	None	None			1						1	Blister; Culture wound negative; Induration; Injection site erythema; Irritability; Pain; Pyrexia	FLU3~SANOFI PASTEUR~UT2477DA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299185	12/10/2007	MA	56.0	56		F	12/06/2007	Approx 6 hours after vaccination, lasted approx 11 hrs chillls, body aches involuntary muscle contraction Fever (not documented)									Y	11/26/2007				PUB	PVT	Zoloft, Wellbutrin, Ceraquil, Multivitamin, Cranberry pill, Billberry pill, Alleve, Chondroitin, Zocor	No	Erythromycin (allergy); bipolar			1						1	Chills; Muscle contractions involuntary; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLAD50AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0299186	12/10/2007	MD	20.0	20		F	12/06/2007	Had flu shot on 12/4/07.  12/6/07 awoke with facial swelling, particularly about the eyes.  Has no symptoms of URI or sensitivity.  No fever.  Patient felt this was a reaction to flu shot.  Patient 22 weeks pregnant.										12/04/2007	12/05/2007	1	None	PVT	PVT			Pregnancy			1						1	Drug exposure during pregnancy; Swelling face	FLU3~SANOFI PASTEUR~U2500AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299187	12/10/2007	NH	7.0	7		M		Inadvertently administered three doses of varicella (2/14/03) (12/01/06). No known s/sx.									Y	12/07/2007			N/A	PVT	PUB	Metamucil, MVI, Albuterol PRN	Well	Stable asthma		NH0746	1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U2524AA~5~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1559U~3~UN~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0299188	12/10/2007	FL	10.0	10		F	12/08/2007	Sunday 12/1/07-Started with myalgia, chills, fever 101-left eye swelling. Then 12/5/07 left eye pain and sinus congestion Tx-Zithromax x 5 days, Tobranex eye ointment 12/6/07										11/30/2007	12/02/2007	2	None	PVT	PVT		None	1) Allergies 2) ADD 3) OCD 4) TICP 5)			1						1	Chills; Eye pain; Eye swelling; Myalgia; Pyrexia; Sinus congestion	FLU3~SANOFI PASTEUR~U2487AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299194	12/10/2007	TX	11.0	11		F	12/10/2007	Reaction around the injection site (R) arm erythema 24 hr later, with area swelling. Erythema extending to mid arm 48 hr later. No lymphadenopathy				Y					Y	12/07/2007	12/08/2007	1		PVT	PVT		None	Asthma-mild, infrequent, Allergic Rhinitis. Bactrim, Macrodantin/Furadanitn	Erythema~Influenza (Seasonal) (no brand name)~1~7.00~In Patient		1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2493AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299195	12/10/2007	WA	66.0	66		M	12/10/2007	Pt had an injection site reaction to his flu vaccine. Pt presented 3 days post flu shot with small lesion, slight amount of exudate. Pt was advised to be seen at physicians office. Culture was done. Flu 1 week later, CK was negative and lesion was healing.									Y	11/30/2007			Wound culture	OTH	PUB	None	None	None reported			1						1	Culture wound; Injection site discharge; Injection site reaction	FLU3~SANOFI PASTEUR~U2525AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299196	12/10/2007	CA	1.3	1	.3	M	12/10/2007	Rash 1 month after vaccine									U	10/30/2007	11/30/2007	31	None	PVT	PVT	None	None	None			1						1	Rash	DTAP~SANOFI PASTEUR~C2657AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2443AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1122U~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0299198	12/10/2007	CA	54.0	54		F	12/10/2007	Sore/painful arm persisting since the vaccination on 11/27/07. Must take medication to relieve pain and unable to apply pressure to arm. Will see doctor soon.										11/27/2007	11/30/2007	3		OTH	UNK		None	None			1						1	Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA305AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0299201	12/10/2007	WI	39.0	39		M	12/07/2007	None stated				Y					Y	11/15/2007	11/15/2007	0		OTH	PVT		None				1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81111~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0299202	12/10/2007	WI	33.0	33		F	12/07/2007	Her incident report states patient had a racing heart and tightness in throat and chest area, VSS, taken WNL.  RN gave her epinephrine, 911 called, S/S's resolved, patient not transported, patient returned to work.									Y	11/06/2007	11/06/2007	0		PUB	UNK		None				1						1	Chest discomfort; Palpitations; Throat tightness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81111~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0299203	12/10/2007	WI	49.0	49		M	12/07/2007	Per incident report, nurse gave him his flu shot.  After he left facility, he returned complaining of arm numbness to first three digits, intermittent at this time 12/04/07.  Will seek medical attention if signs and symptoms persists.									Y	11/08/2007	11/08/2007	0		PUB	PVT		None				1						1	Hypoaesthesia; Limb discomfort	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81111~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0299206	12/10/2007	AZ	64.0	64		F	11/14/2007	C/O lots of pain. Pt. reports dizziness and fainting, unable to raise arm above her shoulder, pain over to collar bone, headache. Went to ER. Pt reports WBC's were way up.				Y					U	11/13/2007	11/13/2007	0	None known	OTH	PVT						1						1	Dizziness; Headache; Injected limb mobility decreased; Pain; Syncope; White blood cell count increased; Back pain; Chest pain; Injected limb mobility decreased; Injection site pain; Laboratory test; Loss of consciousness; Pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLA024AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0962W~2~IM~UN~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~~2~UN~LA~PNEUMO (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0299231	12/10/2007					U	10/05/2007	The wrong medication never reached the patient.  The patient received Hepatitis vaccine as prescribed.  Outside packaging looks the same.  Both items are ordered in large quantities.  Both items stored in same location in the refrigerator due to space constraints.  Flu vaccine only available from August-March.  Syringes look-alike so even after opening they are not easily distinguished.  All the hepatitis was removed from the packaging and placed into a bin.  All the flu vaccine was bagged into zip lock bags and labeled FLU VACCINE.														UNK	UNK						1						1	Drug dispensing error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IN~NS~HEP B (ENGERIX-B)~1|UNK~UNKNOWN MANUFACTURER~~UNK~UN~UN~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA		Influenza
0299213	12/11/2007	PA		1	.0	U	12/11/2007	Rash on belly 12/7/07. Fever up to 100 F for 12 days after immunizations.  Not sleeping well.									Y	11/26/2007				PVT	PVT	desowen  elocon	None	Cystic Kidney Disease, PDA, atopic dermatitis, hydronephrosis			1						1	Insomnia; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U2506AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1259U~1~IM~LL~HEP A (VAQTA)~1|MMR~MERCK & CO. INC.~0865U~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1491U~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0299214	12/11/2007	TX	39.0	39		M	12/11/2007	Received anthrax vaccination late morning Dec 8, 2007. Started feeling bad approx 2230 with facial redness, shortness of breath, puffiness around throat, and rash around injection site. Member took Advil 400 mg. When speaking with Dr., member states he feels back to normal.									Y	12/08/2007	12/08/2007	0	N/A	MIL	MIL		N/A	N/A			1						1	Dyspnoea; Erythema; Feeling abnormal; Injection site rash; Pharyngeal oedema	ANTH~EMERGENT BIOSOLUTIONS~FAV158~7+~SC~LA~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500496P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0299235	12/11/2007	MI	0.17	0	.2	M	12/11/2007	Fluzone trivalent inactivated vaccine given to infant younger than 6 mo. of age.									Y	11/16/2007			N/A	PVT	PUB	None	None	None			1						1	Inappropriate schedule of drug administration	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B127AA~1~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2477DA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0500U~1~IM~LL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~BS4013C~1~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0299238	12/11/2007	VA	6.0	6		M	12/11/2007	Patient had swelling in arm in shich vaccine was administered x 3 per Mom and arm remained swollen x 3 days									Y	11/06/2007	11/06/2007	0		PUB	PUB		None	None. but mother did say that patient had a similar event a couple of years ago but was unsure if it was due to a previous flu shot.			1						1	Oedema peripheral	FLU3~SANOFI PASTEUR~U2523AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299239	12/11/2007	NC	52.0	52		F	12/11/2007	Received Fluzone to left upper arm 10/11/07. Patient noticed that vaccine had been given more anterior upper arm.  10/12/07 developed sorness, redness and warm to touch injection site. 10/13-10/15/07 develped more redness, swelling, itching and overall muscle aches and shooting pains down legs. 10/16/07 seen Employee Health given Benadryl for itching, redness of upper arm 5-6 Inch diameter noted. Generalized itching, not feeling well, headache, weak,  not feeling well. Still have overall muscle aches.  (Has taken flu vaccine in the past) 10/18/07 Employee returned to facility and was given RX for Keflex. Cellulitis left arm.  Swollen lymph nodes left axillary area. Muscle aches all over esp. shoulder, neck, headache. 10/19-10/21/07 Symptoms continued as above except redness of arm and swelling decreased. 10/22/07 Seen muscle aches all over still, I feel terrible all over 10/25/07-10/29/07 Same symptoms overall muscle aches, only able to go to work then stayed in bed over the weekend. 10/30/07 Called out of work 10/30/07 felt to ill to work. 10/31/07 Thru 11-05-07 Increase in stiffness and muscle aches, especially in legs, having sharp pains while sitting in legs. Pain scale 10/10 during this time.  Visit 11/06/07 labs drawn *See Below* Employee temp 99.9 orally. Employee to see Primary physician appt 11/07/07. Labs drawn *See below*  Employee's Supervisor allowed her to take medical leave 11/07/07 thru 11/16/07.  11/19/07 9:30 am left message National Vaccine Injury Compensation PRogram 1-800-338-2382 concerning employee symptoms following flu vaccine. 12/11/07 11:45 am spoke with employee at work. Still have generalized muscle aches and feeling tired. Can barely make it through her work day then goes home and rests for the next day. Pain scale now is somewhat improved 5/10. Dr referred patient to Rheumatologist on 01/16/08 for eval and treatment and to determine relation to pain and flu vaccine.				Y					N	10/11/2007	10/12/2007	1	11/05/07 Executive panel including urinalysis (chem 13 + lipids, CBC) 11/07/07 Dr ordered Sed Rate,CK, Hgb A1C,ANA screen, Rheumatoid factor. Will fax lab results	UNK	UNK		none	Diabetic			1						1	Activities of daily living impaired; Antinuclear antibody; Asthenia; Blood creatine phosphokinase; Body temperature increased; Cellulitis; Erythema; Fatigue; Full blood count; Glycosylated haemoglobin; Headache; Injection site erythema; Injection site pain; Injection site warmth; Laboratory test; Lymphadenopathy; Malaise; Musculoskeletal stiffness; Myalgia; Pain; Pruritus; Red blood cell sedimentation rate; Rheumatoid factor; Swelling; Urine analysis	FLU3~SANOFI PASTEUR~U2440AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299245	12/11/2007	TX	1.0	1	.0	F	12/10/2007	Information has been received from a licensed vocational nurse concerning a 12 month old female who on 19-NOV-2007 was vaccinated with a dose of COMVAX (lot#657380/0377U). Concomitant vaccinations on 19-NOV-2007 included Varivax (lot #658932/1343U), MMR (lot# 657118/0865U), influenza virus vaccine (unspecified), poliovirus vaccine. Illness at the time of vaccination, included a mild ear infection that was treated with amoxicillin. On 27-NOV-2007 the patient was taken to the emergency room and was diagnosed with mild ear infection and also had a fever, mild unspecified rash and mild twitching symptoms. However, these symptoms were not treated. Therapy with amoxicillin was discontinued and therapy with amoxicillin (+) clavulanate potassium was initiated. In the evening on 27-NOV-2007, the patient was taken back to the same emergency room because the patient had 30 minutes of seizure-like activity (twitching). The patient was administered VALIUM and ATIVAN and performed unspecified blood work, chest x-ray and computed axial tomography (all within normal limits). The patient was hospitalized for 24 hour monitoring. During the night, the patient's rash worsened and covered the patient's body. On 28-NOV-2007, the patient was discharged from the hospital. On 29-NOV-2007, the patient follow-up with the pediatrician. Therapy with amoxicillin (+) clavulanate potassium was discontinued and the ear infection, rash and fever were gone. On 29-NOV-2007, the patient recovered. The reporting licensed vocational nurse considered fever, mild unspecified rash, mild twitching symptoms and seizure-like activity (twitching) to be other important medical events. The reporting licensed vocational nurse considered seizure-like activity (twitching) to be immediately life-threatening. Additional information has been requested. 1/30/08-records received for DOS 11/27-11/28/07-DC DX:Convulsions. Otitis media. Previously seen by physician for otitis media which did not resolve. Developed seizure activity with shaking and jerking of upper extremity and twitching. Active tonic colonic seizures observed in ED. Fever 102.			Y		Y	1			Y	11/19/2007	11/27/2007	8	diagnostic laboratory 11/27?/07 - within normal limits; computed axial 11/27?/07 - within normal limits; chest x-ray 11/27?/07 - within normal limits 1/30/08-records received-WBC 5.6, BUN 17, creatinine 0.44, CT brain negative.CXR mild perihilar infiltrates.	OTH	OTH	amoxicillin	ear infection	Unknown		WAES0712USA01134	1						1	Computerised tomogram normal; Muscle twitching; Pyrexia; Rash; Rash generalised	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HBHEPB~MERCK & CO. INC.~0377U~UNK~UN~UN~HIB + HEP B (COMVAX)~1|IPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0865U~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1343U~UNK~UN~UN~VARICELLA (VARIVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0299246	12/11/2007	NY	52.0	52		F	12/11/2007	Shot given at 2:45 pm.  At 4:45 pm itching of breast, rash bright redd on neck, ears arms and shoulders blotchy, no resp distress, no difficulty swalling.  At urgent care at 7 pm rash and itchiness mostly gone. some blotches remained given cimetidine 300 mg 1 po q 8hrs x 3 days, prednisone 20 mg 1 po bid x 3 days, benafryl 2 caps po q 8 hrs.									Y	12/05/2007	12/05/2007	0		PUB	PUB	Niacin 500mg 1 po qd	No	No			1						1	Pruritus; Rash erythematous; Rash macular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA321AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0299248	12/11/2007	OR	2.0	2	.9	F	12/11/2007	Started having partial seizures on Dec 5, sometimes every 5 mins. Dec 10 return to doctor cause they are becoming more frequent, longer & more shaking.				Y					N	11/26/2007	11/26/2007	0	Had lab work done, results were normal. Had EEG on Dec 10 results showed seizures but in between everything looked normal. Has a MRI set up for Dec 26	PVT	PUB	None	None	None			1						1	Convulsion; Electroencephalogram abnormal; Laboratory test; Partial seizures; Tremor	FLUX~UNKNOWN MANUFACTURER~~1~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0299249	12/11/2007	WA	50.0	0	.1	M	12/11/2007	Cold-like congestion, followed by fever (102F) and severe aches for four days; missed one day work on third day (Mon.)									Y	12/07/2007	12/08/2007	1	Did not see a physician (yet).	UNK	UNK		None				1						1	Activities of daily living impaired; Pain; Pyrexia; Respiratory tract congestion	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0299252	12/11/2007	IL	1.5	1	.5	M	12/11/2007	Lt.upper thigh reddened ( 2 ins in diameter) and swollen around injection site. Mom stated reaction occurred approx. 24 hrs after shot given. Mom reported she applied warm cloths to area and gave Tylenol q4h.									Y	12/06/2007	12/07/2007	1		PUB	PUB	Tylenol					1						1	Injection site erythema; Injection site swelling	DTAP~SANOFI PASTEUR~C2657AA~1~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~LUT2474EA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299263	12/11/2007					F	12/11/2007	We received on 29 NOV 2007 from the Regulatory Agency the following information: A 50 or 51-year-old female patient was vaccinated with influenza virus vaccine (manufacturer unknown) in 2006. She developed iritis. The outcome seems to be improved. No further details reported. See also case no. MA2007-1573 (2006/2007). After influenza vaccination in 2007 the patient also experienced iritis (see case nos. MA2007-1571 and MA2007-1572). Company assessment: Seriousness criterion: medically significant. Causality: insufficient data. We have not enough medical details to assess the case definitely. Expectedness assessment according to manufacturer label: The described symptom is unexpected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measures necessary. Regulatory no. ADR 20189179									N					OTH	OTH	No other medications	Unknown			MA20071574	1						1	Iritis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0299264	12/11/2007		51.0			F	12/11/2007	We received on 29 NOV 2007 from the regulatory agency the following information: A 51-year-old female patient was vaccinated with influenza virus vaccine (manufacturer unknown) on 10 NOV 2007. On 13 NOV 2007 she developed iritis. The outcome is unknown. Vaccination history: The patient experienced iritis after vaccination in 2006 (see case nos. MA2007-1573 and MA2007-1574). See also case no. MA2007-1571 (200/2008). Company assessment: Seriousness criterion: medically significant. Causality: insufficient data. Initial iritis has been reported after first flu immunization and the same symptoms reappeared after the second flu vaccination. Iritis is known to be present in the context of rheumatoid dispositions, also in the context of HLA B27 disorders. There are literature reports on iritis after vaccinations. However, literature review showed controverse data on iritis/uveitis after flu vaccination. Data on the subject's medical history or epicrisis are insufficient to ultimately judge the case. Expectedness assessment according to manufacturer label: The described symptom is unexpected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measures necessary. Regulatory authority no. ADR 20189179 It seems to be unlikely that Fluvirin was used as the vaccine was not distributed to the foreign market in this season.									U	11/10/2007	11/13/2007	3		OTH	OTH	No other medications	Unknown	iritis after flu vaccination in 2006		MA20071572	1						1	Iritis; Vaccine positive rechallenge	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0299266	12/11/2007	GA	64.0	64		F	10/25/2007	10/20/07 c/o feeling bad, hot, headache, weak, dizzy, fever of 102 degrees, wheezing - 10/22/07 - Pt saw Dr. for viral infection-was given Rocephin shot - was given Cipro and Atuss 10/24/07-Pt not feeling better - returned to Dr. and was hospitalized for pneumonia improved but still having problems with wheezing.  12/20/2007 MR received for DOS 10/24-29/2007 with D/C DX:  Pneumonia.  Hypertension.  Diabetes Mellitus Type II. Chronic Kidney Disease.  hx of Breast CA with radiation.  Hypothyroidism.  Hyperlipidemia. Pt presented for direct admit from MD's office with c/o fever, cough, SOB and wheezing. Had previously txd with IM Rocephin and Cipro without resolution of sx. Pt txd with abx, steroids, nebs, and O2 prn.  Blood sugar elevations throughout admission.				Y	Y	5			Y	10/12/2007	10/20/2007	8	10/24/07 Chest x-ray - pneumonia. Labs and Diagnostics: CBC WNL on admission with WBCs increased to 11.1 on 10/26/07. CMP with blood glucose 111-285 during admission. BUN 29. Na+ 132.  Sputum cx with normal flora.  Blood cx (-). CXR with R basilar infiltrate, improving on 10/26/07 with ? RML infiltrate 10/27/07.	PUB	PUB	Thyroid medication; LOPRESSOR; LASIX; Iron; Potassium; Multivitamins; Cranberry pills; Stool medicine; DIOVAN; Fish capsule; Insulin - NOVOLOG 6u before breakfast; NOVOLOG 6u lunch; NOVOLOG 9u supper; LANTUS 11u nightly; medication for chol	No acute illness	diabetes, breast cancer, heart surgery 2/4/07, kidneys not working, thyroid, cholesterol. PMH:  CKD, DM, HTN, Breast CA w/ radiation.  Allergies: EES, Cipro.		GA07068	1						1	Asthenia; Chest X-ray abnormal; Dizziness; Feeling abnormal; Feeling hot; Headache; Pneumonia; Pyrexia; Viral infection; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~NOV80433CP~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0299268	12/11/2007	WA	66.0	66		F	12/06/2007	Left arm redness, tenderness and swelling.									Y	11/30/2007	11/30/2007	0	None	PVT	OTH	Cholecalciferol (Vitamin D3), Calcium Citrate, Flaxseed Oil Cap, Glucosamine-MSM-Chondroitin, Multivitamin, Prevacid Cap EC, Amitriptyline, Albuterol	None	Hydrocode allergy, tubular adenoma, colon, multiple recurrent, helicobacter pylori infection, functional bowel disease, gastroesophageal reflux disease, non erosive, morbid obesity, arthritis of knee, bilateral, asthma, diarrhea, dysphagia, meniscus tear, both knees			1						1	Erythema; Swelling; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA307BA~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0804U~2~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0299269	12/11/2007	AR	61.0	61		F	11/30/2007	Pt. states no medical care during this time.  11-30-07 Pt. states on 11-18-07 noted 2 very small red areas on upper Rt. arm.  Pt. states area was about 1/2 above inj. site and 2nd red area was approx. 2 below inj. site.  In 24 hrs pt. states red areas gone.  Pt. states that 3 days after inj. received pt. noticed red discoloration and soreness on Rt underarm extending down to elbow, lasting approx. 7 to 10 days.  Pt. has no redness or soreness on this day.									Y	11/16/2007	11/18/2007	2		PVT	UNK		Back pain	None	pain, swelling~Pneumo (Pneumovax)~1~49.00~In Patient		1						1	Erythema; Injection site erythema; Pain in extremity	FLU3~SANOFI PASTEUR~U2438AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0990U~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0299270	12/11/2007	WV	1.0	1	.0	F	12/07/2007	Received 3 vaccines at well check-up on 12-3-07.  About 24 hours later developed a diffuse red raised urticarial rash and mother took to ER.  She received IM dexamethasone, oral Benadryl.  She was sent home on oral Benadryl & oral Prednisolone.  On 12-7-07 mother reports no more rash.				Y					Y	12/03/2007	12/04/2007	1	None	PVT	PUB	None	None	None			1						1	Rash erythematous; Urticaria	FLU3~SANOFI PASTEUR~U2508AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB206BA~1~IM~RA~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~B08702B~3~IM~RA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0299273	12/11/2007	MN	2.0	2	.2	F	12/05/2007	Wheezing/increased WOB 1 day after vaccine.									Y	12/04/2007	12/05/2007	1		PUB	OTH	None	None	h/o reactive airway disease			1						1	Dyspnoea; Wheezing	FLU3~SANOFI PASTEUR~U2513AA~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~SANOFI PASTEUR~A0394~1~UN~RL~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0299276	12/11/2007	FL	72.0	72		F	12/06/2007	Awaken from sleep with onset of severe pain in anterior thighs and difficulty moving legs.  After ambulating with difficulty for approx 30 minutes pain gradually subsided.  Experienced a lot of respiratory congestion in AM (clear mucous) which lasted for 3 weeks and resulting in absence from work for 2 days 4 days later.									Y	11/07/2007	11/07/2007	0	None	PVT	PVT	vitamins, calcium, fish oil	None	None	none~ ()~~0.00~In Patient|none~ ()~~0.00~In Sibling		1						1	Gait disturbance; Mobility decreased; Pain in extremity; Respiratory tract congestion	FLU3~CSL LIMITED~00249111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0299279	12/11/2007	PA	1.6	1	.6	F	12/05/2007	(R) thigh w/ 3x4 cm area erythema distal to injection site, injection site w/o erythema or induration or DC. C/W large local reaction.									U	12/03/2007	12/05/2007	2	None	PVT	UNK		None	None			1						1	Erythema; Local reaction	DTAPH~SANOFI PASTEUR~U18568C~3~IM~RA~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~UT2474AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B54016A~4~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0299281	12/11/2007	CT	1.0	1	.0	M	12/05/2007	Diffuse rash.										11/23/2007				PUB	UNK		None	Anemia (Fe- defic)			1						1	Rash	FLU3~SANOFI PASTEUR~UT2477FA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0774~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1346U~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0299282	12/11/2007	IL	69.0	69		F	12/03/2007	Oozing, inflamed rash, drs. said it was fixed localized drug eruption on forehead, face, neck, and chest; bright red pustules filled with fluid, swollen eyes, and rash itself created swelling of skin - treated with cortisone pills and creams - rash present for 6-7 weeks.				Y					Y	10/09/2007	10/09/2007	0	None - treated by allergist and dermatologist.	OTH	OTH	Advair, Benicar, Singulair	None	Asthma (allergic), high blood pressure			1						1	Eye swelling; Inflammation; Rash; Rash pustular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~V0481~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0299283	12/11/2007	FL	0.5	0	.5	F	12/05/2007	Pt reports that on the evening after vaccination had ??? febrile seizure, increased temp 103 F and went to ER. NO reaction at 2M/4M.				Y						12/03/2007	12/03/2007	0		PVT	PUB						1						1	Body temperature increased; Febrile convulsion	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC2113114CA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2474AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08700D~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0877U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0299284	12/11/2007	MT	53.0	53		F	12/04/2007	11-6-07 Extreme heaviness, felt and could see movements across (RO) trapesius and down arm-bilateral. Imm. believed approx 3 min, then disappeared. Started again AM 11/20. Took Motrin, 1 bid, Nyquil. Numbness and tingling bilat hands/fingers. (L) residual numbness/tingles				Y						11/04/2007	11/06/2007	2	Neuro assessment	PUB	PVT	None	No	Asthma			1						1	Hypoaesthesia; Neurological examination; Paraesthesia; Sensation of heaviness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA024AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0299285	12/11/2007	WA	28.0	28		M	12/04/2007	2 days since vaccination, inflammation/burning intensely/itchiness/redness/headache.									Y	12/02/2007	12/03/2007	1		MIL	UNK		None				1						1	Burning sensation; Erythema; Headache; Inflammation; Pruritus	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0299286	12/11/2007	CA	32.0	32		F	12/04/2007	Fever to 103.  Local redness and swelling at site of injection with pneuovax.  Malaise, headache started within 6 hours on injection.									N	11/30/2007	11/30/2007	0		PVT	PUB		None	None			1						1	Headache; Injection site erythema; Injection site swelling; Malaise; Pyrexia	FLU3~SANOFI PASTEUR~U2513AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0200U~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0299288	12/11/2007	NY	56.0	56		M	12/06/2007	Pt reported to clinic the day after vaccination saying when he woke up his arm was swollen and painful. On exam patient had large area above and below inj site of redness and warmth. No shortness of breath-Rx'd with ice packs observation									Y	12/04/2007	12/05/2007	1		OTH	OTH	Methadone 30 mg daily	None	CHF, Bronchitis/HBP No known allergies			1						1	Injection site erythema; Injection site warmth; Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80433~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0299289	12/11/2007	NY	48.0	48		F	12/06/2007	States 15 minutes after administration of vaccine, mouth began to feel numb & tingly; lasted about 1 hour.  Headache then started at back of head & aching down entire spine.  Shortly after, began to feel nauseous & vomited.  Felt fine at 4:15pm.									Y	11/29/2007	11/29/2007	0		PVT	PVT	None	Had cold symptoms & felt tired one week prior to receiving flu vaccine.	None; no known allergies			1						1	Bone pain; Headache; Hypoaesthesia oral; Nausea; Paraesthesia oral; Vomiting	FLU3~SANOFI PASTEUR~U2451AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299290	12/11/2007	WI	1.7	1	.7	M	11/30/2007	Parents states blue color not breathing with seizure per ER? Febrile seizure 0030 Tempt 102.1 Dx at ER pulse Ox in ER 99%				Y					Y	11/28/2007	11/28/2007	0		PVT	PUB	None	Cold symptoms?	None			1						1	Cyanosis; Febrile convulsion; Respiratory arrest	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B056BA~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2473HA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB186BA~2~IM~LL~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0299292	12/11/2007	OH	67.0	67		M	11/30/2007	Left arm swelling, rash, some pain seen just above elbow to hand.										11/27/2007	11/27/2007	0	None	PUB	PUB			COPD			1						1	Oedema peripheral; Pain; Rash	FLU3~SANOFI PASTEUR~U1459AA~7+~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0555U~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0299293	12/11/2007	CA	1.3	1	.3	M	11/30/2007	10 cm diameter erythematous, hot wheal around injection site on L thigh where received DTaP.									U	11/29/2007	11/30/2007	1	None	PVT	PUB		None	NKDA, no known medical conditions			1						1	Injection site erythema; Injection site urticaria; Injection site warmth	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B051AA~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2474EA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~AHAUB200AA~1~IM~RL~HEP A (VAQTA)~1	USA		Influenza
0299296	12/11/2007	NE	10.0	10		M	12/01/2007	Client was given 1/2 cc dose of Flu vaccine (Flulaval by GSK) by mistake instead of the vaccine indicated to be given to a child									U	12/01/2007				PUB	PVT		Unknown	Unknown			1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA2AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0299298	12/11/2007	OR	3.0	3		M	12/01/2007	(L) arm with swelling and itching - 15x12 cm area. No limitation in motion - no fever.									Y	11/29/2007	11/30/2007	1	N/A	PVT	UNK		No	Latex allergy			1						1	Oedema peripheral; Pruritus	FLU3~SANOFI PASTEUR~UT2478EA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299300	12/11/2007	NM	66.0	66		F	10/16/2007	Left arm swelling, tenderness, pain inside and outside.  Red, adverse reaction, swollen, itchy, around injection site (see other VAERS).									Y	10/15/2007	10/16/2007	1	None	OTH	PVT	Lovothyroxine, Lisinopril, Mettormir, Levemir, Fosamax, Prednisone, Tranadol, Zetia	None	PCN, Sulfa, Reflex, Thyroid disorder and diabetes, Polymyalgia			1						1	Oedema peripheral; Pain; Tenderness	FLU3~SANOFI PASTEUR~U2218AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0962U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0299301	12/11/2007	OH	38.0	38		F	11/06/2007	Allergic reaction, hives; started approx 30 hrs after vaccine; went to ER 4 days after vaccine after swelling in lips.  Hives from head to toe.				Y					Y	10/31/2007	11/01/2007	1	None	PUB	PVT		None	None			1						1	Hypersensitivity; Lip swelling; Urticaria	FLU3~SANOFI PASTEUR~2505AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299302	12/11/2007	TN	33.0	33		F	12/04/2007	very large localized reaction approx 15 x 17 cm fever, chills, nausea and vomiting										11/29/2007	11/29/2007	0	None	PUB	PUB		None	Asthma			1						1	Chills; Local reaction; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2511AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0962U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0299303	12/11/2007	CO	43.0	43		F	12/04/2007	Patient left Walgreens after immunization and returned to her work.  She called at 5 pm stating that she was salivating, nauseous and had ringing in her ears.  No shortness of breath or swelling or itching.  Told her to contact physician which she did.  I called her back at 5:30 or so and nurse had told her to monitor symptoms and call 911 if much worse.  She came to store at 7 pm and I checked her blood pressure which was 129/91.									Y	12/03/2007	12/03/2007	0	Blood pressure checked at 7:00 pm - 129/91.	OTH	UNK		None	None			1						1	Blood pressure; Nausea; Salivary hypersecretion; Tinnitus	FLU3~SANOFI PASTEUR~U2509AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299305	12/11/2007	CA	4.0	4		M	12/04/2007	localized erythema, swelling, tenderness and fever that developed over approx 36 hours. Seen in ER and treated with Benadryl				Y					Y	11/30/2007	12/01/2007	1	None	UNK	UNK		None	Speech delay			1						1	Erythema; Pyrexia; Swelling; Tenderness	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B051~5~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2478~5~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0924~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~0911U~3~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0299306	12/11/2007	FL	45.0	45		F	11/16/2007	Flu shot right deltoid 11/14.  Within 24 hours had local reaction, redness, itching, some whole body hives.  No anaphylaxis, no shortness of breath.				Y					Y	11/14/2007	11/15/2007	1		MIL	UNK	PPD	None	None			1						1	Erythema; Local reaction; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2506AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299307	12/11/2007	MN	67.0	67		M	12/06/2007	See Notes.				Y					Y	10/11/2007	10/11/2007	0		PVT	PVT		Knee pain	Diabetes M, Ulcerative Colitis, BPH, Lipid Disorder			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2445AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0200U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0299308	12/11/2007	GA	38.0	38		F	11/20/2007	10-26-07 Client took flu shot, went home, later that afternoon broke out in hives on abdomen, arms, legs, hands, hands swollen, client took Benadryl per self - did not go to see doctor. 10-30-07 Called clinic to report reaction.									Y	10/26/2007	10/26/2007	0	None	PUB	PUB	None				GA07078	1						1	Oedema peripheral; Urticaria	FLU3~SANOFI PASTEUR~U2506AA~3~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299313	12/11/2007	GA	2.0	2	.4	M	11/14/2007	Child was given .5ml Flu vaccine and should have been given .25ml. This vaccine was private stock manufactured by manufacturer to be used for ages 6 months and up. We were out of VFC flu so we used our private stock.									Y	11/13/2007				PUB	PVT	None	None	None		GA07072	1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~U2449AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299314	12/11/2007	GA	12.0	12		M	11/14/2007	Client was in for update of immunizations. Clerk checked 11-14-07 GRITS and failed to see that client had received MCV4 and Tdap 1-9-07. When the billing clerk was inputting data into the computer and checking to be sure data had transferred to GRITS she found that these immunizations were replicated.									Y	11/06/2007			N/A	PUB	PUB	None	None	None		GA07071	1						1	Inappropriate schedule of drug administration; Medication error	FLU3~SANOFI PASTEUR~U2449AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB163AB~UNK~IM~RA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2137AA~UNK~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~UC2759AA~UNK~IM~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1106U~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0299315	12/11/2007	GA	54.0	54		F	10/26/2007	Patient had flu vaccine given on Tuesday, 10-23-07.  Phoned 10-25-07 and spoke with someone.  Symptoms are headache, sore throat, stopped up (stuffy nose, neck stiff) but had an appointment to doctor's office at 3:00 pm, 10-25-07.  I phoned back, no answer.  Called 10-26-07 am.  Client stated she saw the doctor.  She had an ear infection, sinus problems and sore throat.  Doctor told her it probably came from flu shot.				Y						10/23/2007	10/25/2007	2		UNK	UNK					GA07070	1						1	Ear infection; Headache; Musculoskeletal stiffness; Pharyngolaryngeal pain; Sinus congestion	FLU3~SANOFI PASTEUR~42446AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299317	12/11/2007	HI	0.7	0	.7	F	10/19/2007	pt became very sleepy, parents had difficulty arousing her and waking her up. This lasted for several hours. Mom called MD. through the answering service.										10/17/2007	10/17/2007	0		PVT	PVT	None	None	None		HI0706	1						1	Somnolence	FLU3~SANOFI PASTEUR~UT2456FA~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299318	12/11/2007	OH	53.0	53		F	11/29/2007	right injection site swelled up size of golf ball, sore arm, painful to move arm (right arm) 11-29-07									Y	11/28/2007	11/28/2007	0		PUB	PUB		None	None			1						1	Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2527AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0554U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0299320	12/11/2007	WI	1.0	1	.0	M	12/06/2007	Tylenol was given by mother at 5 pm. Woke up with a high fever and fussiness. Mother took baby to the Emergency Room. Temperature was 105.4 at hospital then temp declined to 98.9 prior to leaving. Mother stopped by the clinic today so doctor could look at the injection site, the site where Prevnar was given was ecchymotic.				Y					Y	12/05/2007	12/05/2007	0		PVT	PVT	None	None	None			1						1	Injection site haemorrhage; Irritability; Pyrexia	FLU3~SANOFI PASTEUR~U2450AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0075U~4~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08702K~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1472U~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0299321	12/11/2007	LA	34.0	34		F	11/09/2007	11/2/07 - injected with flu vaccine, 11/3/07 - malaise, 11/4/07 - muscle tremor, muscle weakness, sluggish movement of injected arm.  Burning sensation down arm intermittently.  11/5/07 - same.  11/6/07 - came to hospital, injection site bruised.  Location of injection site textbook perfect.  Referred to MD.  No insurance - tried urgent care and ER denied access.  Refuses MRH.  Plans to go to CCC on Thursday.									N	11/02/2007	11/04/2007	2	11/08/07 - diagnosis Neuropathy.  Should clear up within 2-3 weeks.	PUB	PUB	Allegra	None	Hypoglycemia, allergic to iodine, stadol, sulfa, dimetap		LA071202	1						1	Burning sensation; Injection site bruising; Malaise; Muscular weakness; Neuropathy; Sluggishness; Tremor	FLU3~SANOFI PASTEUR~U2487AA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299322	12/11/2007	AZ	1.0	0	1	M	12/07/2007	Mild rash to back and to leg around where shot was administered ((L) thigh). ?Beginnings of several hives to back. Rx for Benadryl given.									Y	12/06/2007	12/06/2007	0	None	PUB	PVT	None	Healthy	None			1						1	Injection site rash; Rash; Urticaria	FLU3~SANOFI PASTEUR~UT2456EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299326	12/11/2007	ME	0.8	0	.8	F	12/11/2007	Pt came in for 2nd dose of flu shot. Pt was supposed to receive .25 cc. Received .50cc instead									U	12/11/2007				PVT	UNK		None	None			1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~U2469AA~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299327	12/11/2007	FL	2.0	2	.7	F	12/11/2007	stuttering after Fluzone Influenza Virs Vaccine									U	11/07/2007			stuttering documented by speech therapy	PVT	PVT	None	None	asthma, speech delay (patient was adopted from foreign country)			1						1	Dysphemia; Speech rehabilitation	FLU3~SANOFI PASTEUR~UT2474RA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299330	12/11/2007	FL	50.0	50		M	12/10/2007	Facial paralysis developed 15-17 days post immunization.  Private MD Dx. Bells Palsy and tx with Antivirals x 7 days				Y					U	11/08/2007	11/25/2007	17		PUB	PUB		None	None			1						1	Facial palsy	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA323AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0299331	12/11/2007	KY	66.0	66		F	12/11/2007	Had flu vaccine and pneumonia vaccine 12/10/07. Received call on 12/11/07 said pts arm was very red and slightly swollen where the vaccine given warm to touch. Pt says slightly painful. Redness extends from elbow to shoulder.				Y						12/10/2007	12/11/2007	1		PUB	PUB	Coumadin, ASA, cholesterol pill, water pill, sugar pill, blood pressure pill	None	Codeine and Morphine			1						1	Erythema; Oedema peripheral; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~02511AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1132U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0299332	12/11/2007	MN	7.0	7		F	12/11/2007	Rash and itchiness within one hour after administration of influenza vaccine.  Patient given Benadryl 25 mg by mouth per mother.									Y	12/10/2007	12/10/2007	0		PVT	UNK		None	None			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U2502AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299333	12/11/2007	VA	4.0	4		F	12/11/2007	Red patch on Rt. thigh at injection site 8x10 cm.				Y					Y	12/06/2007	12/08/2007	2	None	PVT	PVT		No	No			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U2467AA~4~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299262	12/12/2007	CA	80.0	80		F	12/11/2007	On 12/2 at 10:00am, patient attended an appt w/ Dr. as a follow-up for previous stroke monitoring. The doctor administered a mini-check up and with a series of cognitive exercises.  They ended their appt and planned for another follow-up appt. in January or February of 2004. The next day, patient was taken to an 1:30 afternoon appt at her regular physician.  She saw him for a brief 10 minutes as he administered a flu innoculation in her upper left arm.  On Saturday, 12/6/03, patient started experiencing chest congestion, but was alert and keeping to her normal holiday schedule. On Tuesday, 12/9/03, pateint started  experiencing stomache upset, throwing-up, lethargy and aches and pains. She took to her bed.  On wednesday eve, 12/10,after not being able to retain any food, soup of liquids, her children got her ready to take to the hospital. On Thursday morn, patientwas alert, coherent, but  very weak and her  family made attempts to drive her quickly to Emegency Room for treatment.  She went downhill and expired the following morning. 12/26/07-records received for DOS 12/11-12/12/03-Final diagnosis:massive hematemesis and or hemoptysis secondary to coumadin.  Presented to ED with increased shortness of breath, nausea and hemoptysis. Since then had progressive loss of energy. Increasing confusion and agitation. Nonproductive cough. Intubated and sent to ICU. Unsuccessful bronchoscopy. Upper GI bleeding secondary to coumadin and shocked liver. Massive pulmonary hemorrhage with multiple organ damage and coma. Pupils fixed and dilated, unreactive to light. No babinski. Acute oliguric renal failure most likely secondary to hypoxia. Severe metabolic acidosis with increased anion gap most likely seconary to lactic acidosis, hypokalemia. DOD 12/12/03 at 4:10 p.m. 2/19/08-record received-final cause of death pneumonia. Diabetes Mellitus	Y	12/12/2003		Y	Y	1			N	12/03/2003	12/06/2003	3	The emergency room  doctors took  x-rays of her lungs and found  bleeding  areason one side of the lung.  It was uncontrollable and they attempted to  suction it off first, then called a surgeon in to operate.  The surgery was unsuccessfull and she never  regained consciousness. records received 12/26/07-INR of 9. CT of head no acute intracranial hemorrhage detected. Pumonary hemorrahge noted on CT.	UNK	UNK		Diabetes, Arthritis, TIA,Hypertension records received 12/26/07-Reportedly fell two days ago and struck her head.	Diabetes Mellitus, Arthritis. TIA, Hypertension records received 12/26/07-HX of diabetes, cerebrovascular accident, atrial fibrillation.			1						1	Abdominal pain upper; Asthenia; Chest X-ray abnormal; Death; Haemorrhage; Lethargy; Pain; Pulmonary congestion; Stomach discomfort; Surgery; Vomiting	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0299297	12/12/2007	IL	79.0	79		F	12/04/2007	About 12-18 hours after injection, sudden onset of nausea, vertigo, and hearing loss. 10/15/2007 Started taking Antivert 25mg by mouth three times a day for 20 days. When symptoms of nausea, vertigo, and hearing loss, she went to the ER and was referred to an ENT. Doctor determined a sudden onset right vestibular cochlear insult with significant hearing loss. 11/29 Still having problems, noise and pressure still in right ear.				Y					N	10/11/2007	10/12/2007	1	CAT Scan negative, MRI negative, Scanned nodule on Thyroid gland negative.	PUB	PVT	Synthroid	None	Hypothyroidism, Diabetes - diet and exercise controlled.			1						1	Computerised tomogram normal; Deafness; Nausea; Nuclear magnetic resonance imaging normal; Vertigo; Computerised tomogram normal; Deafness unilateral; Ear discomfort; Nausea; Nuclear magnetic resonance imaging normal; Thyroid function test normal; Tinnitus; Vertigo	FLU3~SANOFI PASTEUR~U2450AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2450A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0299351	12/12/2007	MI	55.0	55		M	12/12/2007	Patient presented with GBS/AIDP (weakness/numbness) to Hospital, transferred from other facility.  Patietn received IVIG at other facility.  01/11/2008 Vaccine info obtained from Tag-2 reort and updated in database. 01/09/2008 MR received for DOS 11/25-12/03/2007 with DX: Guillain-Barre Syndrome.   Pt presented to ER with numbness of all extremities, increasing low back pain with sciatica, generalized weakness, ataxia, balance problems and walking difficulty. By hospital day 2 pt was unable to walk and was choking on fluids. Neuro consult notes dysphagia, upper and lower extremity weakness, absent reflexes of the lower extremities, no sensory level. Pt progressed to respiratory failure requiring intubation.  Txd with IVIG.  Pt transfered to higher level of care.   01/28/2008 MR received for DOS 12/03/2007-01/18/2008 with D/C DX:  Guillain Barre Syndrome.  Respiratory Failure s/p trach.  Renal Failure.  HCAP Pneumonia. Pt transfered from above facility where pt had not shown improvement on IVIG. Txd with Plasmapheresis.  Txd for MRSA and Klebsiella pneumonia. Pt had some autonomic instability 2' GBS. HTN and SVT controlled with meds. Pt developed decubitus ulcer stage II.  Renal failure was 2' to sepsis requiring hemodialysis. Renal function improved. Elevated glucose with infections. Anemia txd with iron.  Neck spasms tx with baclofen, robaxin, and ativan.  Pt failed swallow test.  Speaking through Passy Muir valve only during brief episode where CPAP is tolerated. D/Cd in fair condition to Long Term Care Hospital. 2/11/2008 Final Progress note received for 11/25/07 admission.  Assessment DX:  Guillain-Barre Syndrome, progressive, not responding with IVIG or immunoglobulin.  Myositis with hyper CPK and possible myocarditis.  Hyperbilirubinemia and acute liver abnormality likely from autoimmune.			Y	Y	Y	63	Y		U	11/13/2007	11/21/2007	8	EMG, lumbar puncture (CSF). Labs and Diagnostics:  EMG suggestive of demyelinating condition. Glucose consistantly elevated.  CT brain-normal.  MRI lumbar spine shows posterior annular tear at L4-5 with mild disc bulging.  CT pelvis (+) fattly liver changes, CXR unremarkable on admission- later (+) for RLL infiltrate likely pneumonia and intubation.  LP with CSF protein 152.  CSF glucose 125. (+) RBCs, 2 WBCs.  No bacterial antigens in CSF. CSF cx and gram stain (-). Admission K+ WNL, then low (2.1-2.6) then high (6.2-8.8). CPK 280.  SGPT 62, SGOT 52, Hgb A1C 6.9. Troponin 0.03 then 0.12 by 12/3/07.  UA with glucose >1000, trace protein.  Serum Ferritan 812.  Vit B-12 1038.  Blood cx (-). UC (-). Sputum cx (+) Staph aureus (not MRSA). 2D echo (+) for L ventricular hypertrophy with good function. Mild tricuspid insufficiency. Carotid dopplers (+) atherosclerotic changes but considered benign.  Labs and Diagnostics:  12/4/07: CPK 3410. D-dimer 2980. Fibrinogen 1093. MRSA nares (-). 12/9/07 Blood, Urine and fungal cx all (-). 12/10/07 Sputum cx (+) for Klebsiella pneumoniae and E. coli. ABGs repeatedly abnormal.  WBCs up to 13.3 on 12/19/07. C. diff toxin (+).  Hgb & Hct 9.1 & 26.5 on 12/21/07. Traceal aspirate (+) for Staph aureus.  BUN up to 28 on 1/1/08, 95 on 1/15/08. Creatinine 2.4. Blood cx (+) for Klebsiella pneumoniae 1/5/08. AST 50 1/6/08. PT repeatedly increased.	UNK	UNK	Aspirin, lisinopril, hydrochlorothiazide, fish oil, glucophage, flax seed.		NKDA, no birth defects, patient is adopted, PMHx of DM and HTN. PMH:  Hyperlipidemia, HTN, Diabetes, Obstructive sleep apnea on CPAP.  NKDA.	NONE~ ()~~0.00~Patient		1						1	Asthenia; Guillain-Barre syndrome; Lumbar puncture; Albumin CSF increased; Collapse of lung; Dialysis; Life support; Lumbar puncture; Oxygen saturation abnormal; Paralysis; Tracheostomy	FLU3~SANOFI PASTEUR~-U2467AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2467AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0299353	12/12/2007	VA	35.0	35		F	12/12/2007	iN THE HOURS FOLLOWING FLU VACCINE, MMR VACCINE AND PPD SKIN TESTING PLACEMENT PATIENT STARTED TO FEEL BAD INCLUDING SOME RESPIRATORY SYMPTOMS WITH SHORTNESS OF BREATH AND SOME CHEST TIGHTENING INITIALLY SELF TREATED WITH BENADRYL 50 MGS ORALLY BUT SYMPTOMS RETURNEDTHREE TO FOUR HOURS FOLLOWING VACCINE PATIENT WAS ADMITTED TO EMERGENCY ROOM AND TREATED WITH ALBUTEROL AND SOLUMEDROLDISCHARGED HOME LATER SAME DAY				Y					Y	12/11/2007	12/11/2007	0	N/A	PVT	PVT	TUBERSOL PPD SKIN TEST C2671AA 6/21/09 PLACED 12/11/07 12.00ORAL HYPERTENSIVES	NO	NKA HYPERTENSION			1						1	Chest discomfort; Dyspnoea; Feeling abnormal; Respiratory disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~06730708~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|MMR~MERCK & CO. INC.~0808U~UNK~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0299355	12/12/2007	NY	0.92	0	1	F	12/12/2007	ON DAY OF ADMINISTRATION PT DEVELOPED 103-104 FEVER, MALAISE AND FATIGUE, CRYING W/OUT CONSOLATION. ON EXAM 3 DAYS LATER SHE WAS 105 FEVER W/MILDLY BULGING LEFT TYMPANIC MEMBRANE.									Y	12/04/2007	12/04/2007	0	OFFICE VISIT	PVT	PVT						1						1	Crying; Fatigue; Malaise; Pyrexia; Tympanic membrane disorder	FLU3~SANOFI PASTEUR~U2476HA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299357	12/12/2007	IA	42.0	42		M	12/12/2007	Developed parasthesias of extremities, face, then problems walking, while in hospital had developed progressive sensorium impairment and intubated for airway control.  Diagnosed with Bickerstaff's brainstem encephalitis by IgG-GQ1b levels. 1/28/08-records received for DOS 12/5/07-1/1/08-DC DX: Bickerstaff brainstem encephalitis. Methicillin resistant Staphylococcus aureus tracheobronchitis. Respiratory failure, status post tracheostomy. Status post percutaneous endoscopic gastrostomy tube. Constipation. Dermatitis. Oral thrush. Presented to ED with ascending numbness and tingling which started previously the week prior to admission and included fevers, cough and shortness of breath. Sensation of tingling all over body more in face and occipital area with shooting pains. Depressed appetite. Dry cough and shortness of breath for 3-4 weeks prior to admission. Progressing with ataxia and ophthalmoplegia. IVIG, plasmapheresis. Intubated.			Y		Y	33	Y		U	10/23/2007	12/03/2007	41	Anti ganglioside IgG/IgM GQ1b levels >151 1/28/08-records received- MRI brain negative. CQ1B antibody grossly positive. CXR right lower lobe pneumonia. Gram stain or respiratory smear positve gram-negative rodes. CSF protein elevated 59. CBC-WBC elevated 12.3, C reactive protein elevated 2.2. Blood culture no growth. EEG-mildly to moderately abnormal because of the slower activity than expected.	UNK	UNK	Prilosec, Sinemet (for restless leg syndrome), Temazopam, Tylenol, Advil	None	None1/28/08-records received-PMH: gastroesophageal reflux disease, restless leg syndrome, mitral valve prolapse, questionalbe. viral meningitis.			1						1	Blood immunoglobulin G increased; Blood immunoglobulin M increased; Encephalitis; Gait disturbance; Intubation; Paraesthesia; Sensory disturbance	FLU3~SANOFI PASTEUR~U2449AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0299358	12/12/2007	WA	45.0	45		M	12/12/2007	Approximately 1.0 hours after injection on Flulaval Lot#AFLLA029AA given IM patient developed diffuse erythema to back with scattered raised wheels. Scattered patches of same to both arms. NKDA. No other signs or symptoms of adverse reaction. No known exposures to new environmental elements. Symptoms responded well to Benadry by mouth.				Y					Y	10/22/2007	10/22/2007	0	NA	UNK	UNK	Tums, Ibuprophen, tylenol	na	Hx Asthma, Acne, inguinal pain, ulcer disease	no~ ()~NULL~~In Patient		1						1	Erythema; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA029AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0299359	12/12/2007	MI	0.71	0	.7	M	12/12/2007	102.2 Fever brought down with Tylenol, also had otitis media diagnosis (No fever at time of administration of vaccines)									Y	12/06/2007	12/06/2007	0	Otitis media on exam	PVT	PUB	Just prescribed Zithromax for ear.	Left Otitis media	Left otitis media			1						1	Otitis media; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B11043~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT247704~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08690C~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0299361	12/12/2007	MD	27.0	27		M	12/12/2007	Recieved influenza vaccination on 11/2/07 and felt immediate pain at injection site which proceded down arm into 4th and 5th fingers.  Pain has persisted since 11/2/07.				Y					N	11/02/2007	11/02/2007	0	Seen by neurology and had an EMG test.	UNK	UNK	none	no	none			1						1	Electromyogram; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80063~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0299362	12/12/2007	PA	4.0	4		F	12/12/2007	Pt developed urticaria the day after receiving Flu Vaccine.  Hives worsened despite usual daily doses of Zyrtec and Singulair.  Parents took pt. to ER-(X4 by 12/10/2007) Over those 4 visits pt was treated with Zantac, Benadryl,and Prelone and given Depo-Medrol, Solu-medrol and epinephrine. Pt continued to have urticaria. Pt also taken to allergist 12/10/2007. Pt saw Primary Care Physician 12/11 and 12/12/2007. Urticaria much improved 12/12/2007. Recovering				Y					Y	12/06/2007	12/07/2007	1	Hx urticaria and eczema in past. RAST tested showing sensitivity to milk, egg white, and wheat per allergist's consult note.	UNK	UNK	Daily meds-Zyrtec 2.5 BID, Singulair, Pataday	Slight cough, no fever	Eczema; urticaria x 1 in past from exposure to a soap product; sensitivity to egg white by RAST testing but pt tolerates egg containing foods. No family Hx avail.- pt is adopted-(orphan from foreign country)			1						1	Radioallergosorbent test; Urticaria	FLU3~SANOFI PASTEUR~U2489AA~5~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299363	12/12/2007	GA	31.0	31		F	12/12/2007	tokk flus shot (Fluarix, GSK lot#AFLUA316BA) on 11-28-07; developed macular rash 5 days later on 12-2-07; presented to clinic on 12-4-07 treated with loratadine, hydrocortisone cream; rechecked on 12-6-07: still has pruritus and mild rash but improved from previous visit; given Inj. Dexamethasone 4 mg IM; phone conversation with patient on 12-12-07 showed she had improved;				Y					Y	11/28/2007	12/04/2007	6		PUB	PUB	weight loss meds: phentermine, lasix, potassium;	none	none			1						1	Pruritus; Rash macular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0299365	12/12/2007	GA	32.0	32		F	12/12/2007	Running nose, sore throat, coughing, bright yellowish mucus/ phlegm, from nose and throat.										11/26/2007	11/27/2007	1		PVT	UNK		Nov. 21, became sick, fever, chills, body aches. No coughing, no sneezing, no runny nose.	n/a			1						1	Cough; Increased upper airway secretion; Pharyngolaryngeal pain; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0299366	12/12/2007	TN	16.0	16		F	12/10/2007	My daughter has experienced 2 seizures. This occured 6 weeks after gardisil vaccine.  She has never had any health problems prior to this event. 12/18/07-records received-for DOS 12/8/07-DC DX: New-onset seizures. Urinary tract infection, on treatment. New-onset seizures twice with postictal confusion and amnesia. Generalized tonic clonic seizure.				Y	Y	1			Y	10/24/2007	12/08/2007	45	12/18/07-records received-CT head normal. CMP normal. EEG midly abnormal Slightly decreased amplitutde of the discharges out of the left hemisphere compared to right hemisphere. Can be either from a recent seizure out of one of the hemispheres or secondary to a lesion of some sort.	UNK	UNK	Bactrim	12/18/07-records received-urinary tract infection	Penicillin allergy 12/18/07-records received-Allergic to penicillin and celebrex.			1						1	Convulsion	FLU3~SANOFI PASTEUR~u2445aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~amav8176aa~2~UN~RA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~09274~1~UN~LA~HPV (GARDASIL)~1	USA	Hospitalisation	Influenza
0299371	12/12/2007	WI	1.92	1	1	M	12/12/2007	12/3/07 flat red rash, started on abdomen at 0900, spread to rest of body. Mom reports rash lasted approx. 4 days. Reports some loss of appetite and crabby, no other symptoms. Saw family MD afternoon of 12/3/07. No meds or tests.				Y					Y	11/19/2007	12/03/2007	14		PUB	PUB	none	none	none			1						1	Anorexia; Irritability; Rash generalised	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B047AA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2473HA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1276F~3~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B70143A~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1270U~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0299372	12/12/2007	WI	63.0	63		F	12/12/2007	vertigo, heaviness in eyelids as if her eyes were tired though she doesn't actually feel fatigued, hearing loss in R ear.									U	11/05/2007	11/05/2007	0	ACH recept binding 0, ACH receptor modulator pending, striational antibody negative, audiogram/tympanogram showing asymmetrical sensorineural hearing loss in R ear.	PVT	UNK	multivitamin, aspirin	none	adenomatous colon polyps, no allergies			1						1	Antibody test negative; Audiogram abnormal; Deafness unilateral; Sensation of heaviness; Vertigo	FLU3~SANOFI PASTEUR~U2514AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~0743ld~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0299398	12/12/2007	TX	23.0	23		M	12/11/2007	In early September 2007, patient began to experience unexplained weight loss, increased thirst and frequent urination.  He was diagnosed with diabetes at a local hospital on 09/21/2007; diagnosis of Type 1 based on positive GAD antibodies obtained on 9/27/2007.				Y					Y	12/08/2006	09/07/2007	273	6/21/2007:  Mono - test, neg ESR 34 (0-15), CBC - normal x elevated Neut 74.8%, CMP - elevated Glu 233 - elevated total protein 8.5, elevated Creat 1.4, elevated Co2 32.5, decreased AST 10, decreased Alb/Glob 0.8, elevated RF 15.9 (0-13.9), EBV capsid IgG + IgM, EBV NA igG, ANA less than 1:80, 6/21/2007 - 6/25/2007:  ESR 52 (0-20); Trop-1 less than 0.1 (less than 0.1 neg), CPK normal; CBC normal, peak Gluc 263 (70-110); peak Creat 1.4 (0.6-1.3); RA neg, BC x 3 neg, 9/27/2007 Urine Microalb 9.7, Alb/Creat Ratio 5.4; Creat 179.0, Thyrotropin Sensitive 1.46 (0.34-4.82); HgbA1c greater than 16.1% (4.8-6.0); FBS 225 (74-106); CBCd normal; Chol 213 (0-200) Trig 83 (30-150) HDL 50 (39-60), LDL 146.4 (less than -130) Chol/HDL 4.3 (0.17-8.17); UA Gluc 500, Keytones 15, SpGr greater than or equal to 1.030, 8/1/2007 - Coxsacklevirus B1 Ab Serum not done; Coxsackle A-9 Ab less than 1:8.  10/2/2007 - Glutamate Decarboxylase 65 Ab 2.1 U/mL (less than or equal to 1.0); Pancreatic Islet Cell - Ab Negative.	MIL	MIL		None	Pericarditis			1						1	Albumin urine; Antinuclear antibody positive; Aspartate aminotransferase decreased; Blood cholesterol increased; Blood creatine phosphokinase normal; Blood creatinine increased; Blood culture negative; Blood glucose increased; Blood triglycerides normal; Carbon dioxide increased; Epstein-Barr virus antibody positive; Full blood count normal; Glucose urine present; Glycosylated haemoglobin increased; Low density lipoprotein increased; Mononucleosis heterophile test negative; Neutrophil percentage increased; Pollakiuria; Protein total increased; Red blood cell sedimentation rate increased; Rheumatoid factor increased; Thirst; Total cholesterol/HDL ratio normal; Troponin I; Type 1 diabetes mellitus; Urine ketone body present; Weight decreased	FLU3~SANOFI PASTEUR~U2259AA~3~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299401	12/12/2007	VA	54.0	54		M	12/12/2007	Fever 8:30 PM with chill on 12/11/07, took 3 Advil, 2 PM 12/12/07 broke with sweating, no fever on 12/12/07 at 9.30 AM,  but still warm, swelling, erythema at site of injection.									U	12/10/2007	12/11/2007	1		UNK	PVT	Anframil	None	None			1						1	Chills; Hyperhidrosis; Injection site erythema; Injection site swelling; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U2531AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0989V~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0299403	12/12/2007	TN	1.4	1	.4	F	12/06/2007	No adverse side effects reports mother. Was given Tdap vaccine instead of DTaP vaccine by mistake.									Y	11/14/2007			N/A	PVT	PUB		None	None			1						1	Wrong drug administered	FLU3~SANOFI PASTEUR~U2435AA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB181AA~1~UN~LL~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~20527~4~UN~LL~POLIO VIRUS, INACT. (IPOL)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B016BA~4~UN~RL~TDAP (BOOSTRIX)~1	USA		Influenza
0299405	12/12/2007	ND	1.0	1	.0	F	12/10/2007	Patient was given 12 mo. shots. Came into clinic 13 days later showing red, raised area with few bumps in it on Lt. leg (1 1/2 x 1 1/4 area). Redness and raised area started 12-1-07 and resolved 12/7. Was put on an antibiotic 12-3-07 for ear infection.									Y	11/21/2007	12/01/2007	10	None	PVT	PUB	Zyrtec	None	Frequent ear infections			1						1	Ear infection; Injection site erythema; Injection site papule	FLU3~SANOFI PASTEUR~UT2477DA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1409F~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B70143H~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1352U~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0299407	12/12/2007	ME	29.0	29		F	12/12/2007	Pt c/o hard lump - painful to touch that developed in the area of her Tdap administration on 12/6/07.									U	12/06/2007			N/A	PVT	UNK		Right wrist and shoulder pain	Band aids - rash			1						1	Injection site induration; Injection site pain	FLU3~SANOFI PASTEUR~U2469AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2769AA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0299408	12/12/2007	MO	9.0			M	11/30/2007	Swollen, red upper arm.									U				None	PVT	UNK		Conjunctivitis	Penicillin			1						1	Erythema; Oedema peripheral	FLUN3~MEDIMMUNE VACCINES, INC.~500497P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~~2~UN~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0299410	12/12/2007	WI				F	12/10/2007	Patient given injection without flu vaccine in syringe.  Needed to have 2nd injection - resulted in two needed sticks - 2nd injection given vaccine.									Y	10/31/2007	10/31/2007	0		UNK	PVT						1						1	Medication error	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0299177	12/13/2007	NC	1.25	1	.3	F	12/13/2007	MMR was administered along with varicella vaccine on my 15 month old. A week later, my child suffered a severe high fever leading to a febrile seizure which lasted approximately 5 minutes sending us to the emergency room of our local hospital.				Y					Y	11/20/2007	11/30/2007	10	Blood/urine tests were conducted in ER to determine cause of fever and no infection was found so MMR was considered cause of high fever.	PVT	PVT	none	none	none			1						2	Blood sodium normal; Differential white blood cell count; Febrile convulsion; Metabolic function test normal; Urine analysis normal; White blood cell count increased; Blood test normal; Culture urine negative; Febrile convulsion	FLU3~SANOFI PASTEUR~UT2474AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1324F~1~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1338U~1~UN~LL~VARICELLA (VARIVAX)~1|MMR~MERCK & CO. INC.~~1~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~2|VARCEL~MERCK & CO. INC.~~1~UN~UN~VARICELLA (VARIVAX)~2	USA	Emergency room visit	Influenza
0299441	12/13/2007	IN	1.11	1	.1	M	12/13/2007	My son developed a high fever for several days after the vaccination.  He also displayed rapid and uncontrollable shaking,seizure like episodes that resulted in him being hospitalized.  He also experienced breathing difficulty, drowsiness and excessive crankyness/crying.  1/11/08 Reviewed pcp medical records which included vax records w/lot #s & databse updated w/same.  Records reveal patient w/thick eye discharge 10/22/07 otherwise in good health & meeting developmental milestones.  Dx w/conjunctivitis & tx w/eye drops.  Returned to pcp 10/31 w/vomiting,lethargy,  fever, dyspnea, reduced oral intake, & not acting himself x 3 days.  Dx w/viral disease.  Admitted to hospital 10/31-11/1/2007 w/fever & URI.   Returned to pcp 11/26/07 w/purulent discharge from eyes x 3 days, nasal discharge x 4 days, cough. Dx w/conjunctivitis & OM right ear.  Tx w/antibiotics 1/15/08 Reviewed hospital medical records which reveal patient experienced fever & abnormal movements.  Developed low grade fever (99-100) & cold s/s 5 days prior to admit.  Parent & 3 siblings w/colds s/s.  On day of admit, had vomiting & temp max 102.  Parent noted slow rhythmic body contractions followed by drowsiness.  Sent to daycare & continued to have jerky movements & wide based gait noted when taken to pcp on day of admit.  Admitted 10/31-11/1/2007.  On exam had fluid collection right ear. FINAL DX: Viral syndrome.			Y	Y	Y	2			Y	10/22/2007	10/23/2007	1	Information can be obtained from Methodist Hospital. Hospital LABS: CXR WNL.  Stools guaic neg.  Urine & blood c/s neg.	UNK	UNK		None	Acid Reflux PMH: GERD, poor weight gain, resolving w/GI consult.  Questionable mild reactive airway disease.			1						1	Convulsion; Crying; Dyspnoea; Irritability; Pyrexia; Somnolence; Tremor	FLU3~SANOFI PASTEUR~UT2460FA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~ahavb200aa~1~UN~UN~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1351U~1~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0426U~1~UN~UN~VARICELLA (VARIVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0299445	12/13/2007	MI	0.83	0	.9	M	12/13/2007	Seizure--had tonic-clonic jerking lasting about 2 minutes about an hour and a half after flu vaccine				Y					Y	12/12/2007	12/12/2007	0		PVT	PVT	none	none	asthma,milk protein intolerance	high temperature/rash~Measles + Mumps + Rubella (MMR II)~1~1.30~In Sibling1|high temperature/rash~Measles + Mumps + Rubella (MMR		1						1	Convulsion; Tonic clonic movements	FLU3~SANOFI PASTEUR~UT2459PA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299447	12/13/2007	GA	46.0	46		F	12/13/2007	developed malar rash on face on 11-15-07; was prescribed levo-cetirizine by dermatologist which she took for 2 days; rash recurred on 11-19-07; she reported to CDC occ health clinic on 11-27-07; dispensed hydrocortisone cream which she never used; did not continue levo-cetirizine; no recurrence of rash since then;				Y					Y	11/08/2007	11/15/2007	7	CBC and Chem profile were normal;	PUB	PUB	none	none	none			1						1	Full blood count; Laboratory test normal; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~5~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0299448	12/13/2007	WI	0.5	0	.5	M	12/13/2007	R thigh became red and warm after immunization.  Fever spiked to 102 48 hours after immunization.  72 hours after immunization blister appeared and popped.  4 days after immunization child was brought to clinic.  Drained abcess and cultured, began Augmentin.				Y					Y	12/07/2007	12/07/2007	0	Abcess culture	PUB	PUB	NONE	NONE	nkda			1						1	Abscess; Culture; Injection site erythema; Injection site vesicles; Injection site warmth; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B113AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08681A~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1129U~3~~~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0299482	12/13/2007	OH	40.0			F	11/16/2007	Employee became ill with sore throat and GI upset the day after receiving vaccine.  Led to sinus congestion and headache lasting up to 7 days.  Employee called off work on the 3rd day post vaccination to rest.									Y	11/16/2007	11/17/2007	1	none	PVT	PVT		NO	HER MOTHER IS ALLERGIC TO MERCURY HOWEVER THE PATIENT STATES SHE IS NOT.			1						1	Headache; Pharyngolaryngeal pain; Sinus congestion	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA053AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0299483	12/13/2007	OH	34.0			F	10/09/2007	PAIN AND BURNING ON ADMINISTRATION OF VACCINE.  PAIN LASTED UP TO 4 DAYS POST VACCINE									Y	10/09/2007	10/10/2007	1		PVT	PVT		NOEN	MANGOS			1						1	Burning sensation; Immediate post-injection reaction; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLAO53AA~6~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0299494	12/13/2007	OH	62.0			F	10/09/2007	GI UPSET THAT LASTED A WEEK, EMPLOYEE CALLED OFF SEVERAL DAYS POST VACCINE.									Y	10/09/2007	10/10/2007	1	NONE	PVT	PVT		NONE	PCN ALLERGY			1						1	Abdominal discomfort	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLAO53AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0299495	12/13/2007	WI	26.0	26		F	12/13/2007	Influenza vaccination on 12/12/07.  Chills and fever about 5 hours after shot and now red rash covering entire body.									Y	12/12/2007	12/12/2007	0		PVT	PVT		None				1						1	Chills; Erythema; Pyrexia; Rash generalised	FLU3~SANOFI PASTEUR~U2499AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299523	12/13/2007	TX	1.25	1	.3	F	12/13/2007	Urticaria developed approximently 2 hours after administration of vaccines.  Patient seen in office given Benedryl PO and dexamethasone IM.  No respiratory difficulty but condition did not improved and patient was referred to ER.				Y					Y	12/12/2007	12/12/2007	0		PVT	PVT	Amoxil	URI	NONE	none~ ()~NULL~~In Patient		1						1	Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B056CA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2409AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF221AB~4~IM~LA~HIB (ACTHIB)~1	USA	Emergency room visit	Influenza
0299525	12/13/2007	MS	36.0	36		M	12/13/2007	Deep, aching pain beginning immediately after treatment, lasting 6 weeks as of this date.				Y					N	11/03/2007	11/03/2007	0		UNK	MIL						1						1	Pain	FLUN3~MEDIMMUNE VACCINES, INC.~500496P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TD~SANOFI PASTEUR~U1927DA~2~IM~LA~TD ADSORBED (TENIVAC)~1	USA	Emergency room visit	Influenza
0299526	12/13/2007	IL	70.0	70		F	12/13/2007	Influenza vaccine (Fluzone) adm on 11-26-2007 in Rt deltoid.    11-26 through 11-28-07 Rt uppper arm sore.  11-28-2007 client developed a rash on the underside of upper Rt arm, armpit, and Rt chest area--called to report rash on same day.									Y	11/26/2007	11/28/2007	2		PUB	PUB		No.	None known.			1						1	Pain in extremity; Rash	FLU3~SANOFI PASTEUR~U2486AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299527	12/13/2007	GA	52.0	52		F	12/13/2007	ITCH BEGAN EVENING OF VACCINE ADMINISTRATION; USUAL SITE, ARM RED, SORE, GEN MALAISE NEXT 2-3 DAYS THEN RESOLVED; ITCHING INTENSIFIED DAILY ? WHEALS ? WHEEZING; NO RELIEF WITH BENADRYL; GIVEN MEDROL DOSE PAK, CLARITIN;				Y					Y	11/28/2007	11/28/2007	0		PUB	PUB	TYLENOL, MOBIC, MAXZIDE, ACIPHEX		HYPERTENSION, GERD, OSTEOARTHRITIS	HOT,RED SWOLLEN AT INJ SITE, NECROTIC IN CENTER - GIVEN ANTIBIOTIC~Tetanus Toxoid (no brand name)~NULL~39.00~In Patient		1						1	Erythema; Malaise; Pain in extremity; Pruritus; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0299528	12/13/2007	WI	44.0	44		M	12/13/2007	Developed pain in the left lateral, posterior shoulder 3 weeks after the flu shot.  No redness, bruising or swelling noted.  Followed up in Urgent Care and was prescribed with a course of therapy.  Use Ibuprofen. Continues to have aching in the left upper arm.				Y					N	10/24/2007	11/07/2007	14	No diagnostic or laboratory testing done at this time.	UNK	PVT	Unknown	None				1						1	Musculoskeletal pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2450AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299529	12/13/2007	OH	1.25	1	.3	F	12/13/2007	3 days after receiving MMR, Varivax, Hep A and influenza vaccines, patient had a temp of 102 and a generalized tonic clonic seizure.  Per parents, had stopped breathing during this episode and was given chest compression.  EMS arrived and brought patient to Hospital.  There she was observed overnight.  She had no further episodes and was released the next day.  1/15/08 Reviewed hospital medical records which reveal patient experienced fever, irritability, involuntary jerking all extremities, eyes rolling back, loss of consciousness, hypotonia, ashen gray.  Family felt was in cardiac arrest & started cpr for short time before patient began to breath.  EMS foung patient groggy alternating w/irritability/crying.  O2 sat dropped to 94% & placed on blowby O2.  Admitted 12/10-12/11/2007.  Returned to baseline while in ER but admitted for observation.  No further fever or seizure activity while in hospital.  D/C to home & pcp f/u. FINAL DX: febrile seizure.					Y	1			Y	12/07/2007	12/10/2007	3	negative Urine culture	UNK	UNK	none	none	lacrimal duct obstruction PMH:  parent sick w/URI.  GERD, nasolacrimal duct stent.  Uncle w/MS.			1						1	Culture urine negative; Grand mal convulsion	FLU3~SANOFI PASTEUR~U2481GA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB211AA~2~IM~LA~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0527U~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1505U~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0299547	12/13/2007	NC	28.0			F	12/13/2007	This case was reported by a consumer and described the occurrence of spontaneous abortion in a 28-year-old female subject who was vaccinated with Flu vaccine (GlaxoSmithKline) while pregnant. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Flu vaccine (unknown). On 10 November 2007, at an unspecified time after vaccination with Flu vaccine, the subject experienced cramping and light vaginal spotting. An ultrasound performed on 14 November 2007 revealed no sign of pregnancy. HCG levels taken on 14 November 2007 were 168 and HCG levels taken on 16 November 2007 were 107. Heavy bleeding and passing of material began on 17 November 2007, concluding on 23 November 2007. The reporter referred to the events collectively as a spontaneous abortion beginning on 17 November 2007. This case was assessed as medically serious by manufacturer. The spontaneous abortion with heavy bleeding and passing of material resolved by 23 November 2007. Outcome of other reported symptoms was unspecified.									U		11/10/2007		An ultrasound performed on 14 November 2007 revealed no sign of pregnancy. HCG levels taken on 14 November 2007 were 168 and HCG levels taken on 16 November 2007 were 107.	OTH	OTH		Unknown			A0698182A	1						1	Abortion spontaneous; Blood human chorionic gonadotropin positive; Drug exposure during pregnancy; Metrorrhagia; Muscle spasms; Ultrasound abdomen; Vaginal haemorrhage	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0299553	12/13/2007		58.0			M	12/13/2007	We received from a nurse via the Medical Communication the following information on 03 DEC 2007: A 58-year-old man was vaccinated with Fluvirin, batch-no. 80435, i.m. on 16 OCT 2007. Severe headache was reported on 18 OCT 2007 and the patient was admitted to hospital. Laboratory result: elevated IGE of 993. The patient is receiving Prednisone and still has daily mild headaches at the time of report (03 DEC 2007). Company assessment: Seriousness criterion: hospitalisation. Causality: unrelated due to the long duration and intensity of the symptom. Expectedness assessment according to manufacturer label: The reported symptoms are not expected after vaccination with Fluvirin. No change in benefit-risk-ratio. No meaure necessary. NA07-006827					Y	0			N	10/16/2007	10/18/2007	2		OTH	OTH	No other medications	Unknown			MA20071600	1						1	Blood immunoglobulin E increased; Headache	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80435~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0299557	12/13/2007	WA	0.6	0	.6	F	12/10/2007	Intussusception, reduced by diagnostic enema. Presented with vomiting and bloody stools on 12/7/07. 1/7/08-records received for DOS 12/7-12/8/07-DC DX: Intussusception status post reduction. HX of emesis, not tolerating foods and bloody diarrhea. Vomiting. Air contrast enema with successful and uncomplicated reduction of ileocolic intussusception which had originally progressed nearly to the splenic flexture.				Y	Y	1			Y	11/21/2007	12/07/2007	16	air-contrast enema 1/7/08-records received-Stool guaic positive. Ultrasound confirmed intussusception.	PVT	UNK	None	None	None			1						1	Barium double contrast; Enema administration; Haematochezia; Intussusception; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B130AA~2~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2481EA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF192AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B53981H~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1108u~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0299558	12/13/2007	SC	68.0	68		M		Transverse myelitis - spinal cord T1-T4 sensory and motor loss from nipple line down. Loss of GU and GI total control. Loss of motor gait, stability, muscle strength, endurance lower extr.. Sensory changes hands. 1/18/08-records received for DOS 11/8-11/16/07 and 11/28-12/1/07-DC DX: Transverse myelitis. C/O increasing paresthesias, felt well in 8/07, developed upper respiratory infection symtpoms and improved. Began to feel ill 2 weeks after receiving flu vaccine. C/O sore throat, rhinorrhea, nasal congestion, postnasal drip, productive cough, chills and nausea. On 10/24/07 developed progressive neuropathy to ankles, felt numbness of feet progressing superiorly to knees, thighs and upper abdomen. Watery stool. Discharged and readmitted with paresthesias in ascending fashion up to the previous level (umbilicus), 2-3 days after steroid taper.  Follow-up: Residual bowel and GU problems. Paraesthesia of legs - minor gait and stability problems. Have me advised by neurology and infectious disease physicians never to get flu shots, hepatitis, PNEUMOVAX or tetanus shots again. I submitted an event report and responded to a subsequent request. I am responding to this subsequent request but in return, I have a request. Do I get any responses or conclusions from either you, the CDC? It seems to be a one-way street of information in and nothing but stonewalling out from three federal taxpayer funded agencies who should be responding on the subject matter. A response from your agency is requested. 02/02/2010 Senso-neurological changes in feet, legs, groin, back, abdomen and chest. Motor function loss of the lower extremities right greater than left with weakness muscle fatigue, pain and contractility. Pain back awith increased motor activity. Neurological changes affecting the normalcy of bowel, bladder and sexuality functions. Mental stresses associated with pain, disability and recovery; avoidance of depression and demoralization from debilitating disorder and length of recovery time.				Y	Y	13	Y	Y	N	10/09/2007	10/20/2007	11	Cat Scan - MRIs, C-spine, Thoracic spine x 2. Lumbar taps x 2, CSF, Blood, urine swab cultures 1/18/08-records received-MRI brain abnormal incrased T2 signal within the cord at level of T1 through T3 compatible with inflammatory process. Lumbar puncture 49 WBC, 97% lymphocytes, protein slightly elevated at 70, glucose normal and culture negative. Creatinine increased 2.9. CMV IgG false positive. Subsequent lumbar puncture 26 WBC, 91% lymphocytes, protein 49. MRI interval resolution of previously noted abnormal intramedullary signal.	PVT	PVT	Insulin; Immunosuppresive drugs; HBP drugs	NONE	Immunosuppressed - heart transplant1/18/08-records received-PMH: Orthotopic heart transplant. CVA, diabetes, neuropathy, chronic renal insufficiency, hypertension, CMV gastroenteritis. Allergies ACE inhibitor, IVP dye, hydralazine and norvasc, beta blocker.			1						1	Asthenia; Back pain; CSF white blood cell count increased; Change of bowel habit; Computerised tomogram; Culture urine; Faecal incontinence; Gait disturbance; Gastrointestinal disorder; Lumbar puncture; Malaise; Motor dysfunction; Muscle fatigue; Myalgia; Myelitis transverse; Nasal congestion; Nervous system disorder; Neuropathy peripheral; Sexual dysfunction; Upper respiratory tract infection	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80073~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0299578	12/13/2007	MI	73.0	73		F	12/13/2007	Soreness in left shoulder- and down arm. Pain is not constant but occurs with arm movement especially when dressing. Also pain when patient sleeps on that arm. Pt's trying gentle arm exercise.									N	10/05/2007	10/05/2007	0		OTH	PUB	Actonel, Naprosyn prn	No	No			1						1	Injected limb mobility decreased; Musculoskeletal pain; Pain in extremity; Sleep disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA298AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0299579	12/13/2007	PA	37.0	37		F	12/13/2007	Employee developed itching in throat, itching all over body, throat closing within 15 minutes after receiving influenza vaccine.  Was taken to hospital - received Zantac 50mg iv, Benadryl 50mg iv, Solu-Medrol 125mg iv.				Y					Y	11/15/2007	11/15/2007	0	None	PUB	PVT		None	Allergic to penicillin and potassium			1						1	Pruritus generalised; Throat irritation; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA321CA~1~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0299581	12/13/2007	NV	63.0	63		M	12/13/2007	Approximately 8 hours after administration of vaccine, patient developed weakness, chills, fever, arms felt heavy.  Slept for several hours.  Wife took blood pressure of patient which was up to 150/132.  Patient returned to clinic.  Blood pressure read to be 146/88 and patient was feeling better.									Y	12/11/2007	12/12/2007	1		OTH	PVT	Aspirin, Caduet, Celebrex, Lasur, Lisinopril, Kaon-C1	None	No known drug allergies.  History of CAD, Arthritis, Hypertension.			1						1	Asthenia; Blood pressure diastolic increased; Blood pressure increased; Chills; Pyrexia; Sensation of heaviness	FLU3~SANOFI PASTEUR~U2525AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299587	12/13/2007	MN	1.6	1	.6	M	12/13/2007	Patient developed a rash consistent with erythema multiform (minor form) 1 day after 2nd flu vaccine.				Y						12/12/2007	12/13/2007	1		PVT	PVT		None				1						1	Erythema; Erythema multiforme; Rash	FLU3~SANOFI PASTEUR~UT2477AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299593	12/13/2007	RI	4.0	4		M	12/08/2007	Patient complained of pruritis around eyes, face.  No rash on face trunk appeared.  Vitals within normal limits.  Quick dissolve strip (19 mg).  No reactions 25 mg after 15 minutes.  Called at 12:30 pm.  Mom said patient slept when came home.  Is fine and is not itchy anymore.  Mom aware when to call 911/MD.									Y	12/08/2007	12/08/2007	0	None	PVT	PUB	None	None	None			1						1	Pruritus	FLU3~SANOFI PASTEUR~UT2460BA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299600	12/13/2007	NY	2.0	2	.6	M	12/12/2007	12/12/07 Patient present to clinic with a papular erythematous rash, afebrile, good appetite. 12/11/07 Influenza vaccine administered.									N	12/11/2007	12/11/2007	0		PVT	PUB		None, but recuperating from s/p bilateral otitis media 12/4/07				1						1	Rash erythematous; Rash papular	FLU3~SANOFI PASTEUR~UT2456EA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299606	12/13/2007	NV	1.9	1	.9	M	12/12/2007	Developed erythema multiforme 2 days after vaccination. Then developed vomiting, diarrhea, malaise.										11/28/2007	11/30/2007	2		PVT	UNK		None	Developmental delays, Idiopathic thrombocytopenia			1						1	Diarrhoea; Erythema multiforme; Malaise; Vomiting	FLU3~SANOFI PASTEUR~UT2459MA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299608	12/13/2007		22.0	22		F	12/13/2007	Pt received Anthrax and Flumist vaccine 26 Oct 07 does not known if she is/was pregnant. LMP 19 Oct 07. But is somewhat unsure of LMP dates. EDC based on LMP 19Oct07 is 2Nov07.										10/26/2007				OTH	MIL	None	None	None			1						1	Drug exposure during pregnancy; Pregnancy test positive	ANTH~EMERGENT BIOSOLUTIONS~FAV158~6~SC~UN~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500489P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0299610	12/13/2007	OR	5.0	5		F	12/05/2007	erythema at site (L) deltoid edema at site pain/tenderness all symptom in 9cm x 5 cm area on deltoid									Y	12/03/2007	12/04/2007	1		PVT	UNK	None	None	Hx of asthma long age			1						1	Injection site erythema; Injection site oedema; Injection site pain	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B061AA~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2515AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0872~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~1228U~2~SC~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0299612	12/13/2007	MA	53.0	52		F	12/06/2007	Red, itchy blisters and lower left and right legs. Clobetasol Propionate cream .05 twice a day for 2 weeks. Neosporin antibiotic ointment twice a day for 2 weeks. Scar therapy band-aids applied for 12 hrs. To biopsy sites for next three months.				Y					N	10/09/2007	10/12/2007	3	Skin, punch biopsy right pretibial middle and skin punch biopsy right pretibial medial. Drug reaction.	PUB	OTH	Synthoid, Ativan, Meclizine, Advair. Bromfenex PD. Astelin nasal spray.	None	Disease, asthma, fibromyalgia, headaches			1						1	Biopsy skin abnormal; Blister; Erythema; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79896~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0299616	12/13/2007	GA	30.0	30		F	12/06/2007	-Bell's Palsy-facial paralysis (partial), ongoing. Prednisone prescribed. -Developed flu for 48 hours following shot.  1/15/08 Reviewed pcp office note which reveals tongue started feeling numb then right side of face & right ear clogged x 1 day.  Currently pregnant.  Tx only w/tapering steroids & eye gtts. FINAL DX: Bell's palsy.				Y					U	10/24/2007	11/27/2007	34		OTH	PVT		None	Pregnancy	Flu~Influenza (Seasonal) (no brand name)~UN~22.00~In Patient		1						1	Facial palsy; Influenza	FLU3~SANOFI PASTEUR~U2507AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299621	12/13/2007	NC	60.0	60		F		Within Hours of the Pneumonia shot my arm was hurting. By 10:00 pm I was in such pain I was crying, I could not raise my arm. On 10/25 I went back to the doctor. He gave me Prednisone for 10 days which did not help. He then sent me to an Orthopedic Dr. he put a shot of cortisone in my shoulder and by the next day I could move my arm, still had pain. Was out of work for 3 weeks.				Y					Y	10/23/2007	10/23/2007	0		PVT	PVT						1						1	Crying; Hypokinesia; Injected limb mobility decreased; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0299665	12/13/2007	WA	34.0	34		M	12/13/2007	Patient complained of pain at injection site, traveled down arm.  Patient states it hurts like past rotator cuff injury.  Patient has seen orthopedist, had corticosteroid injection.				Y					Y	11/07/2007	11/08/2007	1	MRI was done.  Showed fluid.  No apparent injury.	PVT	PVT		None	Has history of rotator cuff injury, asthma, allergic Rhinitis.			1						1	Injection site pain; Nuclear magnetic resonance imaging abnormal	FLU3~SANOFI PASTEUR~U2458GC~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299673	12/13/2007	MO	1.0	1	.0	F	12/13/2007	Patient was transported via ambulance to emergency room after having a seizure per mother.  She had a fever of 103.8 after motrin.				Y					Y	12/10/2007	12/10/2007	0	CBC-nl, Hgv-nl, HC-nl	PVT	PUB	None	None	None			1						1	Convulsion; Full blood count; Pyrexia	DTAP~SANOFI PASTEUR~C2607AA~4~~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT24770A~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~04994~4~~LL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~8087004~4~~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1470U~1~~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0300476	12/13/2007	KY	0.14			F	11/02/2007	An non serious event of vaccination administration error occurred in a fourteen-month-old female.  The report was received from a registered nurse in the USA.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  The reporter indicated the infant has had wheezing issues.  The infant received a one-time dose of Flumist intranasally on 02-Nov-2007.  On 02-Nov-2007 the reporter indicated a infant was inadvertently administered Flumist, the mistake was discovered 30 minutes after dosing.  The administering nurse thought Flumist was indicated for children over 1 year of age; the infant was also reported to have wheezing issues.  The reporter called to check on the infant the day after dosing and no problems had been observed and the family has not contacted the health department to report any adverse effects.  Outcome: the infant had no ill effects.  Further dosing with Flumist is not indicated.  Causality assessment was not reported for this medication error.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U	11/02/2007	11/02/2007	0		PUB	OTH	None	Wheezing	Infant with possible wheezing or asthma history		MEDI0006137	1						1	Medication error; Wheezing; Wrong drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~50049DP~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0300477	12/13/2007	VA	4.0			M		A non-serious spontaneous report of bronchitis and pneumonia was received from a parent concerning a four-year-old male.  The child's medical history included cold, seasonal allergy, postnasal drip, atopic, and peanut allergy.  No concomitant medication was reported.  The patient received FluMist on 03Nov2007.  On 07Nov2007, a parent reported that her son was diagnosed with bronchitis/early pneumonia four days following Flumist vaccination.  The child had sniffles the day of vaccination.  The mother states that it was difficult to tease apart her son's colds from his seasonal allergies and postnasal drips.  The child was started on a Z-pack.  The patient was recovering.  The causality was not reported.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.										11/03/2007	11/07/2007	4		OTH	OTH	None	Postnasal drip, seasonal allergy, cold, peanut allergy, atopic	Peanut allergy, seasonal allergy		MED0006157	1						1	Bronchitis; Pneumonia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0300478	12/13/2007	NC	0.9	0	.9	M	11/09/2007	A medical assistant reported a non-serious event of FluMist vaccine intentionally given to a ten-month old male. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. No medical or drug history information has been reported for this patient. The patient received Flumist on 09-Nov-2007. The reporter stated the physician ordered that FluMist be given at the insistence of the infant's mother. The vaccine is indicated for patients two years to 49 years of age. No adverse events were reported in the patient. Further dosing with Flumist is not reported. The reporter did not provide a causality assessment for this. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U	11/09/2007	11/09/2007	0		PVT	OTH	Concomitant Drug(s) Not Reported		NI		MEDI0006176	1						1	Medication error; Wrong drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0300479	12/13/2007	CO	0.7			U	11/09/2007	A non-serious report of medication error has been received from a physician concerning a nine-month-old infant. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. No medical history nor concomitant medications were provided. The patient received Flumist on an unknown date. The physician realized that FluMist had been inadvertently administered to a nine-month-old infant. No other events were reported. No outcome for the event was provided by the reporter. No dechallenge or rechallenge occurred. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U					OTH	OTH	Concomitant Drug(s) Not Reported		NI		MEDI0006181	1						1	Medication error; Wrong drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0300480	12/13/2007	OH	4.0	4		F		A non-serious report of viral infection with wheezing, fever, runny nose and congestion was received from a consumer in the USA concerning a four-year-old female.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  No medical history was reported.  However, the child received four other vaccines at the time of Flumist administration.  The patient received FluMist on 22Oct2007.  Four days after receiving FluMist and four other vaccines, the child experienced runny nose, congestion, cough, and wheezing with fever.  Per the parent, the pediatrician believes her daughter has a viral infection and is treating the child with nebulizers and steroids.  The symptoms improved but the child still had intermittent episodes of wheezing with fever.  No dechallenge or rechallenge occurred.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U	10/22/2007				PVT	OTH	None		FluMist and four other vaccines administered simultaneously on 22-Oct-2007.		MEDI0006195	1						1	Cough; Pyrexia; Rhinorrhoea; Upper respiratory tract congestion; Viral infection; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0300481	12/13/2007	SD	2.0			F	11/26/2007	A non-serious event of expired vaccine administered occurred in a 30-month-old Caucasian female. The report was received from a registered nurse. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. No medical or drug history information has been reported for this child. The child received a 0.5 ml dose of Flumist intranasally. On 19-Nov-2007 the reporter indicated a child was inadvertently administered Flumist that had expired. The reporter indicated that there is a program to return unused medication and this medication should have been returned but was not, the medication was still in the freezer. No adverse events were observed. Outcome: the child had no ill effects. Further dosing with Flumist is not indicated. Causality assessment is not applicable for this medication error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U	11/19/2007				PVT	OTH	Concomitant Drug(s) Not Reported		NI		MEDI0006203	1						1	Expired drug administered; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~500436P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0300483	12/13/2007	WA				U	11/21/2007	A non-serious report of vaccine administration error was received from a pharmacist concerning a child of an unknown age.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  No relevant medical or drug history information was reported.  The child was given FluMist on an unknown date.  The child had received FluMist and some of the second nostril dose was sprayed into one of the child's eyes.  No adverse events were reported from this error.  Rechallenge is not applicable.  Causality assessment is not applicable.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  04-Dec-2007: No additional information will be available since the contact information of the reporter no longer valid.									U					UNK	UNK	None		None		MEDI0006215	1						1	Accidental exposure; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0300484	12/13/2007	OH				U		A non-serious event of flu symptoms has been received from Hoffman-La Roche Inc. (ref #07 US10920 Team B) from a physician in the USA concerning a child.  No medical or drug history was provided for this patient.  On an unspecified date, the child received FluMist.  A physician reported FluMist was given to a child.  The child's father then got the flu and the caller felt the child developed symptoms.  Outcome for the reported adverse event was not reported.  Additional FluMist dosing was not reported.  The reporting physician did not provide a causality assessment for the adverse event reported.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  MEDI0006234 is a linked case involving the child's father.									U					OTH	OTH	None		None		MEDI0006235	1						1	Influenza; Secondary transmission	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0299538	12/14/2007	CA	0.5	0	.5	M	12/14/2007	Lethargy,extreme stomach cramps/pain,extreme sleepiness and vomiting. Came in cycle of 30-40 minutes. In awake state was happy and smiling. When cycle began he would begin with sleepiness and lethargy, then stomach pain then vomit then would fall immediatly to sleep. My son was diagnosed with  intussusception on 11-23-07. Unknow if directly related to any vaccines, however, without sufficient research to rule out reaction for new Rototeq in particular I felt the need to report 12/26/2007-records received for DOS 11/23-11/24/07-DC DX: Intussusception. Air contras enema failed to reduce. Successful laproscopic surgery with incidental appendectomy.One day history of colicky abdominal pain and poor feeding. Three episodes of nausea and vomiting. Temperatue 38.2.				Y	Y	1			Y	10/01/2007	11/23/2007	53	intussusception 12/26/07-records received- Barium contrast enema showed intussusception up to mid transverse colon, paritally reduced into the cecum. WBC 13,900.	UNK	UNK	Amoxacilian, finished last dose sat prior to 11-23-07	12/26/07-records received-HX of upper respiratory infection.				1						1	Abdominal pain upper; Intussusception; Lethargy; Somnolence; Vomiting	DTAP~SANOFI PASTEUR~c2657aa~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~ut2459la~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|RV5~MERCK & CO. INC.~1052U~3~UN~UN~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0299736	12/14/2007	AZ	25.0	35		M	12/14/2007	Within a few hours of vaccintion, he experience low grade fever and myalgias. Next day, a pruritic maculopapular rash appeared over the trunk and extremities.									Y	12/11/2007	12/11/2007	0	none	PVT	PVT	none	none	none			1						1	Myalgia; Pyrexia; Rash maculo-papular; Rash pruritic	FLU3~SANOFI PASTEUR~u2463AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299747	12/14/2007	SC	70.0	70		M	11/29/2007	Local site reaction to influenza virus vaccine.  Redness, hot and edema from shoulder to elbow of L arm at site.  c/o fatigue x3 days.  Symptoms resolved on their own.									Y	10/29/2007	10/29/2007	0		UNK	UNK			GERD, AODM, Hx smoking, white, male			1						1	Erythema; Fatigue; Local reaction; Oedema peripheral; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA032AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0299758	12/14/2007	WV	68.0	68		F	12/14/2007	within 24 hrs of injection patient developed redness and swelling of the entire right upper arm--pt was instructed to apply cool compresses qid and recheck in 24 hrs--pt did f/u in 24 hrs and swelling had resovled significantly				Y					Y	10/29/2007	10/29/2007	0		PVT	PVT		No illness reported	allergy--sulfa--previous diagnosis: hypothyroid, tachycardia, HTN, R lung nodule, hyperlipidemia, hiatal hernia, IFG			1						1	Erythema; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81110~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0990U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0299759	12/14/2007	FL	1.58	1	.6	M	12/14/2007	Pt had localized erythema and induration. He also had a 3-day course of fever.									Y	12/04/2007	12/04/2007	0		PVT	PVT	None	Had rhinorrhea, conjunctivitis and cough. Did not have fever, vomiting and diarrhea. No rashes.	None			1						1	Injection site erythema; Injection site induration; Local reaction; Pyrexia	DTAP~SANOFI PASTEUR~C2797AA~4~IM~UN~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2477DA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0819U~4~IM~UN~HIB (PEDVAXHIB)~1	USA		Influenza
0299813	12/14/2007	CA	31.0	31		F	12/14/2007	Pt was given the Inactivated Influenza Vaccine IM in the Left Deltoid Muscle. She received this injection on 12/12/2007. The area was red, bruised, swollen, warm to the touch, painful to the touch, and was approximately 3 inches in diameter around the injection site.				Y					U	12/12/2007	12/13/2007	1		MIL	MIL	Prednisolone Acetate 1%, Suspension, Ophthalmic	None				1						1	Injection site bruising; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2506AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0299814	12/14/2007	OR	1.0	1	.0	M	12/14/2007	Patient was seen in our office on 11/21/2007 with recurrent rash on his left thigh at the sitre of his injections.  He experienced a slightly raised red area of about 1-2 inch diameter around the injection site on the day of vaccination.  Otherwise he did well and had no obvious pain or fever. Initial redness faded, then rash returned 11/21/07.  On exam he was noted to be alert and generally well appearing.  He was active, playful, and afebrile.  Focused exam revealed 3 pinpoint erythematous papules on the anterior chest and in addition a coalescent area of erythema, slightly dry papular testured skin of the left upper outer thigh.  It is 3 x 3 cm in size.  It is nontender.  No drainage.  It has been excoriated and there are a couple of scratch marks near this that have a slightly raised welted appearance. 12/14/2007:  spoke to patient's grandmother who reports that he now has bruising at the injection sight and a half dollar size lump.  Patient is afebrile, cranky.  Injection site area does not appear tender nor is it hot to touch.				Y					N	11/12/2007	11/13/2007	1		UNK	UNK	Luride Drops  (0.5 (1.1) mg/ml) PO daily	none	Polydactyly, history of wheezing			1						1	Excoriation; Injection site bruising; Injection site erythema; Injection site induration; Injection site rash; Injection site urticaria; Rash; Rash erythematous; Rash papular; Urticaria	FLU3~SANOFI PASTEUR~UT2456BA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0377U~3~IM~LL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~1470F~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PPV~MERCK & CO. INC.~854013A~4~IM~LL~PNEUMO (PNEUMOVAX)~1|VARCEL~MERCK & CO. INC.~0725U~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0299815	12/14/2007	CA	50.0	50		M	12/14/2007	Please note: Pt states given birthdate is false. He says his birthday is give or take 3 years. Pt states that one week after his vaccinations, he began to feel fatigued and had a stiff back. States slept 11 hours and felt better except for stiff hamstrings. The following evening he noted that his chest was covered in small red spots. Patient states during this episode he continued to work and do his normal everyday activities. As of 12/13/07, pt states the spots have almost disappeared. Pt states he only reported symptoms because he was worried about having potentially exposed his dentist and dental staff, including a pregnant dental hygenist, to measles or something else contagious. Pt received no treatment for his symptoms. Pt was also taking oral typhoid during this time but we have no information on manufacturer or lot since it was prescribed by his physician.									Y	11/30/2007	12/07/2007	7	none	PUB	PVT	none, other than oral typhoid	none	no known allergies except maybe pollen. Otherwise, nothing to report			1						1	Erythema; Fatigue; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U2454AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~U1031-2~UNK~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0283U~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TDAP~SANOFI PASTEUR~C2825AA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0299816	12/14/2007	MD	47.0	47		M	12/14/2007	PAIN AT INJECTION SITE AT TIME OF VACCINATION WHICH HAS PERSISTED TO REPORT DATE (7 WEEKS). REPORTS DECREASE IN ROM OF AFFECTED ARM/SHOULDER. THESE SX ARE STILL BEING EVALUATED.				Y					N	10/22/2007	10/22/2007	0	N/A	UNK	UNK	LISINOPRIL, AVANDIA	N/A	HYPERTENSION, DIABETES MELLITUS			1						1	Injection site movement impairment; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80063~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0299862	12/14/2007	AL	29.0	29		F	12/14/2007	Redness (pink) 1/2 - 1 diameter vaccine site at left deltoid.  Ice applied, Benadryl 25mg given.									Y	12/14/2007	12/14/2007	0	Blood pressure - 99/64, temperature - 98.2, heart rate - 54	OTH	PUB	Steroid 50mg	None	Non-allergic rhinitis, migraines			1						1	Blood pressure; Heart rate; Injection site erythema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA055AA~1~IM~~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0299864	12/14/2007	NV	5.0	5		M	12/14/2007	Fever & Malaise (general flu like symptoms for several days following vacination)									U	12/12/2007	12/12/2007	0		PUB	PVT						1						1	Influenza like illness; Malaise; Pyrexia	FLUX~UNKNOWN MANUFACTURER~unk~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0299866	12/14/2007	WI	45.0	44		F	12/14/2007	Sore arm from the flu shot.  Began shortly following the shot and was not better 3 weeks later.  Having difficulty raising arm above head. Started physical therapy that continues.									U	10/31/2007	10/31/2007	0	x-rays	UNK	PVT	Unknown	None	None noted			1						1	Injected limb mobility decreased; Pain in extremity; X-ray	FLU3~SANOFI PASTEUR~U2450AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299868	12/14/2007	IA	6.0	6		M	12/14/2007	Arm red, swollen & warm.  Hives on chest.									Y	12/12/2007	12/13/2007	1	None	PVT	PVT	None	None	None	unknown~Influenza (Seasonal) (no brand name)~UN~0.00~In Sibling		1						1	Erythema; Oedema peripheral; Skin warm; Urticaria	FLU3~SANOFI PASTEUR~U24806A~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299869	12/14/2007	WI	5.0	5		F	12/12/2007	Symptoms of headache, sore throat, fever, and decreased appetite.									Y	12/06/2007	12/07/2007	1	None	PVT	OTH	None	None	None			1						1	Decreased appetite; Headache; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500479P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0299870	12/14/2007	WI	4.0	4		M	12/12/2007	Symptoms include headache, sore throat, fever and decreased appetite.  Fever was up to 102.5.				Y					U	12/06/2007	12/07/2007	1	None	PVT	OTH	None	None	NKA	unknown~Influenza (Seasonal) (FluMist)~UN~0.00~In Sibling		1						1	Decreased appetite; Headache; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500479P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0299871	12/14/2007	NY	77.0	77		M	12/14/2007	Patient died suddenly while snowblowing.    12/18/07 Reporter states no autopsy done.  Received vax record which confirms lot # as reported.  2/29/08 Received death certificate which states COD as cardiac arrest w/CAD as contributing factor.	Y	12/03/2007							N	11/30/2007	12/03/2007	3		PUB	PUB		celiac disease	Aortic stenosis; Hyprtension			1						1	Sudden death	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA282DA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Results in Death	Influenza
0299872	12/14/2007	NC	63.0	63		F	12/10/2007	Leg aches, nausea, headaches, didn't feel good for 1 week. Couldn't move arms/legs for 1-1 1/2 days.									Y	10/16/2007	10/30/2007	14	Elevated liver enzymes	OTH	PVT	Nexium; Diovan; Vytorin	None				1						1	Feeling abnormal; Headache; Hepatic enzyme abnormal; Hypokinesia; Nausea; Pain in extremity	FLU3~SANOFI PASTEUR~U2469AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299876	12/14/2007	CA	57.0	57		F	12/10/2007	24 hours after vaccine had onset of bilateral calf and thigh cramping lasting 3.5 weeks. Severe pain and cramping as well as bilateral knee/joint pain. treatment heat and occasional Motrin. I've had influenza vaccines yearly since 1983 never had a reaction.									Y	11/08/2007				PVT	UNK		None	Recent hyperthyroid			1						1	Arthralgia; Muscle spasms	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0299877	12/14/2007	IL				F	11/12/2007	Influenza vaccine was administered on 10/19/07.  On 10/24/07 patient came to the health center complaining of a sore throat.  Throat reddened, afebrile.  Mentioned that on 10/20/07-10/21/07 she developed a rash & fever.  By 10/27/07 she was better but now has a sore throat.  Child had croup at the time.  Rash was not evaluated.									Y	10/19/2007	10/20/2007	1		OTH	PVT		None	Penicillin			1						1	Croup infectious; Pharyngeal erythema; Pharyngolaryngeal pain; Pyrexia; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA029AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0299879	12/14/2007	MD	35.0	35		F	12/07/2007	Received Pneumovax immunization in right deltoid IM on 12-06-2007.  Within 24 hrs. patient has cellulitis , swelling, erythema, painful to move arm below injection site.  T=99.6 po.  Tx: rest, elevation, alternate ice/heat, Aleve BID for discomfort, Benadryl liquid as directed and Keflex QID x7 days.									U	12/06/2007	12/06/2007	0		PVT	PVT	Xopenex inhaler, Advair 100/80, Allegra 180 qD, Singulair 10 qD, Nasacort AQ	None	Allergic to codeine, asthma, eczema, sinusitis	none~ ()~~0.00~In Patient		1						1	Cellulitis; Erythema; Pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2529AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0546U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0299880	12/14/2007	WA	3.0	3		M	12/10/2007	Inadvertently gave Fluvirin 0.5ml. Contacted CDC (#1-45356717), CDC states expects possible minimal side effects, which should resolve, such as those stated on the V IS for influenza.									Y	12/06/2007				OTH	PUB		None	NONE REPORTED			1						1	Inappropriate schedule of drug administration; Medication error	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80959~1~UN~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0299881	12/14/2007	KY	36.0	36		F	11/15/2007	Reaction to flu vaccine - swelling, itching, red blotches.									U	10/22/2007	10/22/2007	0	None	UNK	UNK	None		None			1						1	Pruritus; Rash macular; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80682~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0299882	12/14/2007	TN	3.0	3		F	12/14/2007	none stated										12/13/2007	12/13/2007	0		PVT	PUB						1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79717~1~UN~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB175AA~1~UN~LL~HEP A (HAVRIX)~1	USA		Influenza
0299884	12/14/2007		55.0			M	12/07/2007	A) 1 week F/U on knee pain B) 1 week F/U on R-shoulder pain C) Med refills D) Recheck spot on R-hand E) toes and fingers went numb after shots on 11-30-07 6-8 hours later, Felt good next morning, about all day. Sunday pretty bad, coming back Monday, gone by Tuesday wierd deal. Both hands and feet. (Hands and feet all circ went out); Patient also indicates he had trouble breathing next day After shot like the Flu.													Pulse 79; Respiratory 20; Blood Pressure 126/82; SAT 95 ;HT 5ft8in	UNK	UNK			duracef, ceftin, keflex			1						1	Arthralgia; Blood pressure; Dyspnoea; Feeling abnormal; Heart rate; Hypoaesthesia; Musculoskeletal pain; Oxygen saturation; Respiratory rate	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0299886	12/14/2007	NY	29.0	29		F	12/13/2007	Blurred vision for 30 min, resolved spontaneously.				Y					Y	12/06/2007	12/06/2007	0	None	PVT	PVT						1						1	Vision blurred	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80435~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0299887	12/14/2007	PA	0.84	0	.8	M	12/12/2007	Child given wrong vaccines. Given HPV, Fluzone 12/11/07 1140 AM.									U	12/11/2007	12/11/2007	0	None	PUB	PUB		None	None			1						1	Wrong drug administered	FLU3~SANOFI PASTEUR~U2524AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0930U~1~IM~LL~HPV (GARDASIL)~1	USA		Influenza
0299900	12/14/2007	MD	66.0	66		F	12/14/2007	12/13/2007 approx. 5 pm pt had onset of chills and temp of 101.5. 12/14/2007 r arm with redness from site of injection moving down past elbow. r arm hot to touch. Pt called pcp and was started on antibiotic for cellulitis									U	12/12/2007	12/13/2007	1		PUB	PVT	synthroid	none	nka			1						1	Body temperature increased; Cellulitis; Chills; Erythema; Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~u2488aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0946U~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0299904	12/14/2007	CT	11.0	11		F	12/14/2007	One day after recvng the vARIVAX VAC (SUB Q IN RIGHT TRICEPS AREA)pt developed redness swelling.Was examined 2 days after recvng the immun and had redness and swelling(15 x 12cm)over injection site with a 2 x 4 cm area of intact fluid filled vesicles with some confluence of vesicles within the area of redness										12/12/2007	12/13/2007	1		UNK	UNK	none		none			1						1	Injection site erythema; Injection site swelling; Injection site vesicles	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80825~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~ac52B021BA~UNK~IM~~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1492u~UNK~SC~~VARICELLA (VARIVAX)~1	USA		Influenza
0299906	12/14/2007	PA	34.0	34		M	12/14/2007	Within 30 minutes of getting the flu vacine my husband experienced a minor stroke.  After 2 days in the hospital and numerous tests, no other health condition could be found that would indicated why he had a stroke.  We were told it was probably due to the vacine.  He will now be on medication probably the rest of his life becasue since he has had a stroke there is a higher risk he will have another.  At this point, most mobility has returned he still has problem writing.  12/21/07 Reviewed hospital medical records which reveal patient experienced right sided weakness, right mouth drooping, slurred speech x 2 days.  MRI done as outpatient revealed very mild acute stroke.  By hospital admission, functions had returned to 95% normal w/residual slurred speech & very minor weakness of right arm & leg.  Had bump on right deltoid where received flu vax. Admitted 12/5-12/6/2007.  Neuro consult done.  Tx w/anticoagulant.  D/C to home on continued anticoagulant. FINAL DX: none provided.  Neuro consult states pontine stroke.				Y	Y	2			U	12/03/2007	12/03/2007	0	He had an MRI w/ contrast, full blood workup, electrocaridiagram, sonogram of the caratiod arteries and heart (with bubbles).  The information from the doctors office is that he was given a inactivated influenza vaccine. LABS: echocardiogram.  Carotid US revealed minimal plaque formation & no stenosis.  MRI revealed left pontine infarct most likely from small vessel ischemic disease & Chiari I malformation identified.  CBC, chemistry & UA WNL.  Urine c/s WNL.	UNK	UNK	prednisone; fluricortisone		congental adrenal hyperplasia salt wasting PMH: congenital adrenal hyperplasia tx w/Florinef & steroids x 20 years.  Asthma.			1						1	Cerebrovascular accident; Echocardiogram; Electrocardiogram	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80822~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0299919	12/14/2007	OR	62.0	62		F	12/13/2007	Had vaccine Zoster 8 days ago, within 24 hours had a red painful rash erupt on right ear which has since spread via small, scattered painful vesicles, to upper right shoulder, back and torso.									Y	12/03/2007	12/11/2007	8	None	PVT	PVT		Well	Diabetic, HTN, Hypothyroid			1						1	Blister; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80435~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARZOS~MERCK & CO. INC.~1414U~1~~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0299920	12/14/2007	CA	13.0	13		M	12/14/2007	10 hrs - + rash - in morning, raised rash over entire body - No other complaints - no fever, H/A										12/10/2007	12/11/2007	1	None	PUB	UNK		None				1						1	Rash generalised	FLU3~SANOFI PASTEUR~U2509AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2425AA~1~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0299923	12/14/2007	TX	23.0	23		M	12/14/2007	Description: I received the spv last Thurs. Since last night I have been nauseated and have diarrhea. Also, notes cramping, diarrhea x5 denies bld. Stated everything goes through him including water. Is feeling dehydrated. Denies fever, and chest pn. Noted SOB, stated a co-worker had stomach flu last week. Symptom: Diarrhea Start: 12/10/2007; Symptom: Nausea w/o vomiting Start: 12/11/2007; Symptom: Abdominal Pain Start: 12/10/2007 Comment: described as cramping; Symptom: Dyspnea (shortness of breath) Start: 12/11/2007 Comment: told by ER it was due to dehydration				Y					U	12/04/2007	12/10/2007	6	no testing	MIL	MIL	denies					1						1	Abdominal pain; Dehydration; Diarrhoea; Dyspnoea; Muscle spasms; Nausea	ANTH~EMERGENT BIOSOLUTIONS~FAV158~1~UN~UN~ANTHRAX (BIOTHRAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~3~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|TYP~SANOFI PASTEUR~Z0664~1~UN~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0299925	12/14/2007	TX	19.0	19		F	12/14/2007	Pt usually faints when receiving a vaccination. However, after patient warned me of her passing out, she had a brief seizure instead. Lasting under 1 minute, clonic-tonic jerking.									Y	12/12/2007	12/12/2007	0		OTH	PVT	Unknown	None				1						1	Convulsion; Tonic clonic movements	FLU3~SANOFI PASTEUR~U2466AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299910	12/15/2007	TX	17.0	17		F	12/15/2007	Approximately 20 - 30 minutes (12:40) after receiving injection, she returned to clinic with complaints of throat tightening up. Face sl. flushed.  No signs of respiratory distress.  Could talk.  Forwarded to emergency room.				Y					U	12/15/2007	12/15/2007	0		MIL	MIL		Denies				1						1	Flushing; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA049AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0299911	12/15/2007	FL	57.0	56		M	12/15/2007	19 hours after the shot, I got dizzy, light-headed and felt weak. I had to sit down as my walking was unsteady and I was afraid of passing out. I had a friend sit with me for a half-hour and I drank water. The dizziness lasted about one hour. Within three hours the lightheadedness was gone. My temperature remained normal throughout. I had slight perspiration for one hour.									Y	12/12/2007	12/13/2007	1	flu shot	UNK	UNK	none	none	sulfa drugs, erythromycin	none~ ()~NULL~~In Patient		1						1	Asthenia; Dizziness; Gait disturbance; Hyperhidrosis	FLUX~UNKNOWN MANUFACTURER~DXV04.8~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0299912	12/15/2007	MN	46.0	46		F	12/15/2007	Headache, muscle weakness in legs, tingling in fingers and legs, facial paralysis. Physical, occupational, and speech therapy required.  Diagnosed as Guillain-Barre Syndrome.  7 sessions of plasma exchange required.  Intensive care req., catheter, and iv required.  First and only flu shot ever received.  12/26/2007 Vax record received.  Info updated in database:  GSK AFLUA321CA./pc 01/07/2008 MR received for DOS 11/28-12/06/2007 with Discharge/Transfer DX:  Guillain-Barre Syndrome.  Depression.  Bi-polar disorder. Pt presented to ER with c/o progressive generalized weakness.  Sx began 5-6 [[name]]s prior to admission with lower extremity tingling which progressed up to the tongue.  Generalized weakness also progressing from lower extremities upward, resulting in falls. Upon PE DTRs were absent in the LEs with unsteady gait and decreased vibratory sensation. Respiratory status remained stable.  Developed 7th cranial nerve involvement with facial droop, difficulty smiling and raising eyebrows.  Some urinary retention resulting in [[name]] cath placement. Txd with plasmapheresis with slow improvement. Pt initially had some anxiety due to psych meds being held, but this improved on resumption. Pt transferred for further rehab. Per 60 [[name]] follow up: Some residual speech and facial symptoms related to GULLIAN [[name]] felt like due to influenza vaccine approx 2 wk prior to onset of symptoms. Patient continues to have improved resolving symptoms and findings from her GUILLAIN [[name]].			Y	Y	Y	16			U	11/12/2007	11/26/2007	14	Labs and Diagnostics:  CSF with protein 176, albumin 157, WBCs 2, IgG 31.6, synthesis rate 48.64.  MRI brain, cervical and thoracic spine with no evidence of demyelinating disease, minor degenerative changes.  EMG abnormal.	UNK	UNK			PMH:  Depression, Low back pain, Hx of Bi-polar disorder.  NKDA.			1						1	Asthenia; Facial palsy; Guillain-Barre syndrome; Headache; Intensive care; Paraesthesia; Plasmapheresis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA312CA~1~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Life Threatening,Hospitalisation	Influenza
0299915	12/16/2007	NY	57.0	57		F	12/16/2007	Approximately 5 hours after injection, I developed a high fever, intense chills, bad headache, queasiness followed by projectile vomiting, extreme skin/nerve sensitivity (could barely tolerate anything touching my skin), which lasted approximately 6 hours.  I was very weak for about 24 hours, then healthy again.									Y	11/15/2007	11/15/2007	0		PUB	UNK	none	none	none			1						1	Asthenia; Chills; Headache; Hyperaesthesia; Nausea; Pyrexia; Vomiting projectile	FLU3~SANOFI PASTEUR~U2529AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0299916	12/16/2007	CA	2.0	2	.1	F	12/16/2007	CHILD WAS FIT BEFORE ADMINISTERING THE VACCINATION ....INJECTION ADMINISTRED:  FLU SHOT + HEPATATIS A VACCINE                                    ADVERSE EVENTS: VOMITTING, DIARHEA , LOSS OF APPETITE, FEVER FOR PAST 2 DAYS.										12/13/2007	12/15/2007	2		PVT	UNK	-NONE-	-NONE-	-NONE-			1						1	Anorexia; Diarrhoea; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~NA~2~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~NA~2~IM~RL~HEP A (NO BRAND NAME)~1	USA		Influenza
0299297	12/17/2007	IL	79.0	79		F	12/13/2007	Seriousness criteria: other - medically significant.  Initial report received on 05 December 2007 from a health care professional.  A 79-year-old female patient, with no illness at the time of vaccination, had received a right deltoid, intramuscular injection of Fluzone SV 2007-2008, lot number U2450AA, on 11 October 2007.  The patient had a history of diabetes and hypothyroidism.  Within 12-18 hours post-vaccination, the patient experienced nausea, vertigo, and hearing loss in the right ear.  The patient was examined in an emergency room and by an ENT consultant.  CAT scan, MRI, and thyroid tests were negative.  She was treated with Antivert.  Per the reporter, the hearing loss with noise and pressure in the right ear persists.  Diagnosis was sudden onset of right vestibular cochlear insult with significant hearing loss.  At the time of this report, the patient had not recovered.				Y					N	10/11/2007	10/12/2007	1		UNK	UNK			The patient had a history of hypothyroidism and diabetes (controlled by diet and exercise).		200704187	1						2	Computerised tomogram normal; Deafness; Nausea; Nuclear magnetic resonance imaging normal; Vertigo; Computerised tomogram normal; Deafness unilateral; Ear discomfort; Nausea; Nuclear magnetic resonance imaging normal; Thyroid function test normal; Tinnitus; Vertigo	FLU3~SANOFI PASTEUR~U2450AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2450A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0300025	12/17/2007	CO	62.0	62		M	12/13/2007	Seriousness criteria: other-medically significant.  Initial non-serious report received from a consumer on 08 November 2007.  A male patient (age and date of birth not reported) had received a dose of flu vaccine (trade name, lot number, route/site of administration not reported) on an unspecified date in 2007 and approximately two weeks post vaccination, he started to develop a tingling sensation in the crown of his head, sometimes accompanied with headaches and dizziness.  The patient had experienced similar symptoms following flu vaccinations the previous two years.  At the time of the report, the symptoms were not yet as severe as last year.  No additional information was provided.  Follow-up information received on 04 December 2007 from the patient.  Following review of the reported events, this case was upgraded to serious.  A 62-year-old male patient had received a left deltoid, intramuscular injection of Fluzone Sv 2007-2008, lot number not reported, on 14 October 2007.  No other vaccines were administered within four weeks of the 14 October 2007 vaccination.  At the time of vaccination, the patient had a staphylococcal infection in his mouth.  Past medical history included leukemia which was in remission.  Other medications at the time of vaccination were none.  Fourteen days post-vaccination, the patient experienced a tingling/numbness sensation in the crown of his head, unspecified effects on balance, and blurry vision.  The current symptoms were reported as moderate to severe and wake the patient at night.  The event required examination by a physician.  At the time of this report, the patient had not recovered.  Contact information was provided for the patient's personal physician.  (The patient had been seen by a neurologist after experiencing events post-vaccination in 2006; and, at that time, an unspecified CAT scan was negative.  Per the reporter, symptoms had occurred in 2005 and 2006 following Fluzone vaccination and lasted eight to nine months).  The reporter of this case is the same as for cases 2007-03791 and 2007-03792, which involve the same patient who experienced tingling sensation in the crown of the head, headaches and dizziness following receipt of flu vaccine (trade name not reported) in 2005 and 2006.				Y					N	10/14/2007	10/28/2007	14		UNK	UNK		Illness at the time of vaccination included a staphylococcal infection of the mouth.	The patient experienced similar effects of tingling sensation in the crown of the head, headaches, and dizziness following receipt of flu vaccination the previous two years.  Past medical history included leukemia which was in remission.	localized tingling, dizziness, headache~Influenza (Seasonal) (no brand name)~2~0.00~In Patient	200703793	1						1	Balance disorder; Dizziness; Headache; Paraesthesia; Sleep disorder; Vision blurred	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0300027	12/17/2007	CO	60.0			M	12/13/2007	Seriousness criteria: other - medically significant.  Initial non-serious report received from a consumer on 08 November 2007.  A male patient (age and date of birth not reported) had received a dose of flu vaccine (trade name, lot number, route/site of administration not reported) on an unspecified date in 2005 and developed a tingling sensation in the crown of his head, sometimes accompanied by headaches and dizziness (onset dates not reported).  No additional information was provided at the time of this report.  Follow-up information received on 04 December 2007 from the patient.  Following review of the reported events, this case was upgraded to serious.  An approximately 60-year-old male patient had received an injection of influenza vaccine, manufacturer not reported, lot number not reported, on an unspecified date in 2005.  The symptoms that the patient experienced lasted eight to nine months and had also included a numbness sensation in the crown of his head.  The patient recovered from the event.  Contact information was provided for the patient's personal physician.  The reporter of this case is the same as for cases 2007-03791 and 2007-03793 and involve the same patient who experienced events following influenza vaccination in 2006 and 2007.				Y					Y					UNK	UNK					200703792	1						1	Dizziness; Headache; Hypoaesthesia; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0300028	12/17/2007	CO	61.0			M	12/13/2007	Seriousness criteria: other - medically significant.  Initial non-serious report received from a consumer on 08 November 2007.  A male patient (age and date of birth not reported) had received a dose of flu vaccine (trade name, lot number, route/site of administration not reported) on an unspecified date in 2006 and developed a tingling sensation in the crown of his head, sometimes accompanied by headaches and dizziness (onset dates not reported).  The reporter indicated that this sensation lasted for well over eight months, with no further diagnosis from many doctors.  No additional information was provided at the time of this report.  Follow-up information received on 04 December 2007 from the patient.  Following review of the reported events, this case was upgraded to serious.  An approximately 61-year-old male patient had received an injection of influenza vaccine, manufacturer not reported, lot number not reported, on an unspecified date in 2006.  The symptoms that the patient experienced lasted eight to nine months and had also included a numbness sensation in the crown of his head.  The patient was examined by a neurologist, and an unspecified CAT scan was negative.  The patient recovered from the event.  Contact information was provided for the patient's personal physician.  The reporter of this case is the same as for cases 2007-03792 and 2007-03793 and involve the same patient who experienced events following influenza vaccination in 2005 and 2007.				Y					Y					UNK	UNK			The patient experienced similar effects of tingling sensation in the crown of the head, headaches and dizziness following receipt of flu vaccination in 2005.	Localized tinlging, dizziness, Headache, Numbness of head~Influenza (Seasonal) (no brand name)~1~0.00~In Patient	200703791	1						1	Computerised tomogram normal; Dizziness; Headache; Hypoaesthesia; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0300031	12/17/2007	MI	0.55	0	.5	M	12/17/2007	Mom states that after vaccinations she gave son 0.4ml of Tylenol. She states that at 11:30pm her fiance noticed that child was flushed and groaning and had a temp of 104 degrees. mom took client to hospital.  Mom states that they gave him Motrin and Benaryl.  She states that they did blood cultures and blood counts. She states they sent her home with instructions to continue giving motrin and tylenol and gave her time intervals and dosage. Since the evening of 12/13 mom states that his color is normal, his temps have been between 97.9 and 100.5 degrees and that the area where he received his shots looks like bee stings. Blood cultures done inthe emergency room were negative.				Y					Y	12/13/2007	12/13/2007	0	Mom states blood cultures taken. Phone call made by this CHN to pediatrician's office and they have not yet received lab results. States client has appt 12/18/07.	UNK	UNK	tylenol per mother	none per mother	none per mother			1						1	Blood culture; Body temperature increased; Flushing; Injection site inflammation; Moaning	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B127AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2523AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B54013C~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1129U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0300032	12/17/2007	VA	25.0	25		F	12/17/2007	Pt received flumist inhalation on 12/13/2007. Pt c/o if facial tingling within 10 minutes of vaccination. Pt waited in vaccination area for approximately 20 minutes. She then left and returned 20 more minutes later c/o a fine rash on her left arm and face. Pt was instructed to have someone drive her to the clinic.									Y	12/13/2007	12/13/2007	0	none	UNK	UNK	lo/ovral	none	unknown			1						1	Paraesthesia; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500502P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0300033	12/17/2007	AZ	39.0	39		M	12/17/2007	Highly atypical Influenza vaccine.  Vaccine felt like fire going in, and I could feel pain as the serum seeped through the muscle.  Vaccination lasted longer than usual flu vaccine.  Injection site turned red from the moment of injection and began to harden and get warm.  Site closed and never abscessed, but around injection site and satellite areas were painful, hot and red.  I went to the ER.  The next morning still in level 3 pain.  I started Cephalexin, and they gave me a prescription for Bactrim.  I also covered the area with Bactroban ointment and a bandage.  ER staff told me to draw a circle around redness which was about the diameter of a quarter.  I was instructed to start the Bactrim immediately if it escaped the border.  Within hours it had grown beyond the border.  I started the Bactrim along with the Cephalexin.  I felt an extreme level of tiredness, as if my body was having to fight with all it had.  The next day the antibiotics had arrested the growth of the bacteria, and the area started turning a dark purple healing color and redness, tenderness, hardness, and heat went away from main lesion and satellite ones.  I believe that this was an invasive soft tissue infection with no drain that could have become quite serious if the antibiotics had not been started one day after the infection.  I have had many shots, administered allergy shots to myself.  I have never had a shot be so sore for so long, and react the way that did.  If it had only been bacteria from the skin, it probably would have abscessed and not had sub-dermal satellite areas that also never abscessed.  I believe that that shot was contaminated with MRSA.  I don't know if Merck manufacture it, but there is contamination being reported in another of their vaccines.  I feel lucky to be alive.				Y					Y	12/10/2007	12/10/2007	0	ER Visit	PVT	PUB		HIV				1						1	Immediate post-injection reaction; Infection; Injection site discolouration; Injection site discomfort; Injection site erythema; Injection site induration; Injection site pain; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0300034	12/17/2007	AZ	1.17	1	.1	M	12/17/2007	diffuse erythematous maculopapular dermatitis requiring no treatment									U	12/03/2007	12/14/2007	11		PUB	PUB			eczema; recurrent wheezing (now dx with asthma)			1						1	Dermatitis; Rash erythematous; Rash maculo-papular; Rash papular	FLUX~UNKNOWN MANUFACTURER~U2481EA~1~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~0747U~1~SC~RL~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~1182U~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0300040	12/17/2007	MD	33.0	33		F	12/17/2007	Postpartum month 6. Menorrhagia and purpuric rash over legs and oral mucosa about 1 week after vaccine administration. Thrombocytopenia on labs - 1000 platelet count. Given prednisone 100 mg by mouth daily. Platelet count rose to 37,000 in 10 days, but then started dropping again and in another 11 days was down to 8000. Given Anti-D Immune globulin- platelets rose to 87,000 2 days later and to 421,000 1 week after the Anti-D.  1/18/08 Reviewed hospital medical records which reveal patient experienced extremely heavy menstrual flow beginning on 11/6/07.  Next day she noted red spots on legs & oral mucosa, called her pcp who sent her to ER.  Exam revealed petechial rash & bruises.  Heme consult obtained.  Tx w/IV steroids w/improvement.  D/C to home on oral steroids w/heme f/u. FINAL DX: thrombocytopenia, possibly idiopathic thrombocytopenic purpura; hypocalcemia, resolved.			Y	Y	Y	2			Y	11/07/2007	11/14/2007	7	Thrombocytopenia as mentioned under (7). Viral serologies negative for CMV/EBV/Hepatitis viruses?Parvovirus/Rubella. Hematuria with Tntc (too numerous to count) RBCs on U/A. Blood culture -ve x1. Indirect Coombs test -ve. DIC panel -ve. Bone marrow biopsy and aspirate results pending.   LABS: Initial plts 1,000.  Final plts 11,000.  CXR WNL.	UNK	UNK	None	None	PMH: 6 mos post partum via c-section. Chronic recurrent sinusitis w/recently resolved sinus congestion.  Seasonal allergies.  Asthma in remote past.  Sinus surgery.  Family hx of cardiac disease.			1						1	Aspiration bone marrow; Biopsy bone marrow; Blood culture negative; Coagulation test; Coombs indirect test negative; Haematuria; Menorrhagia; Platelet count decreased; Postpartum state; Purpura; Red blood cells urine positive; Thrombocytopenia; Urine analysis abnormal; Virus serology test negative	FLUX~UNKNOWN MANUFACTURER~Unknown~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0300045	12/17/2007	MI	45.0	45		F	12/17/2007	Received shot on 12/14/07 at 12:00 P.M.  Ate a meal at 4:00 P.M. that afternoon. 40 minutes later began vomiting and started having problems breathing.  Went to the emergency room at hospital because conditions only got worse.  Was given a breathing treatment and something for the vomiting.				Y					Y	12/14/2007	12/14/2007	0		UNK	UNK	Norvasc, Vasotec, Zyrtec		seasonal allergies,zithromax			1						1	Dyspnoea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0300048	12/17/2007	LA	1.5	1	.5	F	12/17/2007	102.3-102.8 temp									U	12/14/2007	12/16/2007	2		PVT	PVT						1						1	Body temperature increased	FLU3~SANOFI PASTEUR~UT2477AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0797U~2~IM~RL~HEP A (VAQTA)~1	USA		Influenza
0300052	12/17/2007	TX	9.0	9		F	12/17/2007	Patient received varicella vaccine in lower left deltoid on 13 Dec 07, at which time influenza vaccine was given in left upper deltoid.  This was her second varicella vaccine, the first was given on 9 Dec 99.  Earlier that day she had been seen by her primary pediatrician for rhinorrhea and fever of 100, she was diagnosed with allergic rhinitis.  Her pediatrician directed her to the immunization clinic to get influenza and varicella shot since she has asthma.  The following day about 24 hours after vaccination she was noted to have a blister rash on her arm at the site of the varicella vaccine.  She was seen at a satellite pediatric clinic where she was prescribed (per Mom) oral antibiotic and topical antibiotic.  The following day the blistering rash was larger and then it popped.  Mom states the erythema extended from her elbow to shoulder, and her fingers were swollen.  The following day she returned to the satellite peds clinic and they recommended an infectious disease referral.  Today (4 days after vaccination) she has a shallow ulceration with minimal erythema just at vaccination site.  Mom reports that the antibioitic ointment causes itching when they put it on so we will investigate possible neomycin sensitivity.				Y					Y	12/14/2007	12/15/2007	1	None	MIL	MIL	Zyrtec, Flonase	Mild URI viral illness	Asthma, Allergic Rhinitis			1						1	Injection site erythema; Injection site rash; Injection site ulcer; Injection site vesicles; Oedema peripheral; Pyrexia; Rhinitis allergic; Rhinorrhoea	FLU3~SANOFI PASTEUR~U2516AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1496U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0300056	12/17/2007	IL	78.0	78		F	12/17/2007	Area of vaccine administration red and sore to touch and without heat(according to PA notes) with red streak running from it.				Y					U	12/11/2007	12/11/2007	0		PUB	PUB	blood pressure medication, diuretic, and allergy medication	None	HBP on BP medication and a diuretic.  Also takes an allergy pill for watery eyes, sneezing, etc			1						1	Injection site erythema; Injection site pain; Injection site streaking	FLU3~SANOFI PASTEUR~U2494AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0300057	12/17/2007	IL	39.0	39		F	12/17/2007	13 Dec 4 pm received injection; by 10 pm right arm was painful and it was difficult to sleep.  14Dec 6:30 am Advil not helping the pain; swelling started; couldn't raise arm above shoulder. Through out that evening and night pain and edema worsened.  15 Dec early morning red, blotchy marks appeared over upper forearm and into shoulder area.  Pain radiated down the arm, up into shoulder and across the back.  Later that am was seen by local MD; right axillary lymphnodes were reportedly swollen, afebrile, Omnicef started. Continued to take Advil to help with pain.  Red blotchy marks were gone after two days of Omnicef (17 Dec). Today (17 Dec) Still continues Advil.  Pain and edema are still present but improving.				Y					Y	12/13/2007	12/13/2007	0	none	PVT	PVT	Zoloft, Singulair, Flovent, Nasonex, Klonopin, Tylenol, Advil, Excedrin, Maxair.		Question hypothroidism, Question adrenal insufficiency, chronic insomnia, Eczema, Chronic headache, Question irritable bowel syndrome, Depression, Anxiety disorder, S/p tonsillectomy and adenoidectomy, S/p D & C.			1						1	Erythema; Injected limb mobility decreased; Lymphadenopathy; Oedema peripheral; Pain in extremity; Rash macular; Sleep disorder; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA311AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1084U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0300058	12/17/2007	CO	78.0	78		M	12/17/2007	Guillane Barre including lower extremity numbness and inability to walk. Elevated spinal protein at 410.  6 plasma exchanges with improvement.  Transfer to Rehab hospital 12/14. Lyrica for new neuropathy symptoms. 12/31/07-records received for DOS 12/3-12/18/07-DC DX: Guillain-Barre syndrome. Status post total plasma exchange times six.   Neruopathic pain. Serratia marcescens urinary tract infection. Benign prostatic hypertrophy. Prior to admission seen in ED 11/23/07 for C/O difficulty breathing with DX of primary acute and chronic dyspnea, D.M. leg edema. ED 11/24/07-C/O weakness-low potassium, chronic shortness of breath. edema improved. ED 11/27/07-C/O back pain. Developed progressive weakness and numbness in hands and feet and unable to stand.  At time of discharge able to move arms and legs but unable to walk. Weaker proximally than distally. Developed significant neurpathic pain related to nerve regeneration. Discharged to transitional care.			Y		Y	15	Y		U	10/20/2007	11/03/2007	14	spinal protein 410 12/31/07-records received-CT chest negative. MRI of brain and C-spine and L-spine no evidence of mass lesions or significant impingement. Lumbar puncture elevated protein at 410.	UNK	UNK		S/P Knee replacement.vaccinated prior to discharge. 12/31/07-records received-Prior total knee arthroplasty 10/18/07-.	vicodin 12/31/07-records received- PMH: type II diabetes, hypertension, narcoelpsy and lumbar spinal stenosis.			1						1	Abasia; CSF protein increased; Drug hypersensitivity; Guillain-Barre syndrome; Hypoaesthesia; Neuropathy	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA318BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Life Threatening,Hospitalisation	Influenza
0300059	12/17/2007	PA	64.0	64		M	12/17/2007	Patient had a flu shot - thereafter has suffered an unknown condition that includes swelling of the fat tissue, pain and hardening of the tissue in the upper vaccinated arm and forearm region, which caused intramuscular edema and related systems.  No doctor has been able to identify a remedy to date.  12/31/207 MR received for DOS 12/16-18/2007 with DX:  Panniculitis of R arm s/p flu shot.  Pt presented with induration of the R arm.  Pt had previously had erythema and swelling of the hand and forearm as well, was txd with abx and redness resolved. However induration progressed and includes most of the triceps, some of biceps, and down to and including some of the forearm.				Y	Y	2			N	11/01/2007	11/05/2007	4	Several MRIs have been conducted and a biopsy is planned. Labs and Diagnostics:  Muscle bx shows small focus of chronic inflammation.  MRI R arm shows subcutaneous edema and enhancement of subQ fat in the posterior aspect of the arm and forearm.  Minimal intramuscular edema.  No abscess.  Sed rate WNL. CBC WNL. ANA (-). Complement 3&4 WNL. Lyme (-).  Blood cx (-).	UNK	UNK	wellbutrin, zoloft, norvasc, lipator, benicor,cingulair, nexium	none	none. PMH:  Lumbar stenosis/herniated disc with laminectomy and microdiscectomy, bronchial asthma, HTN, and hyperlipidemia.			1						1	Induration; Muscle swelling; Nuclear magnetic resonance imaging; Oedema peripheral; Pain	FLUX~UNKNOWN MANUFACTURER~unknown~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0300085	12/17/2007	TX	0.5	0	.5	M	12/14/2007	Information has been received from a physician concerning a 6 month old male, that was born with a fractured left clavicle because he was big at birth, and who had no other history other than sniffles, who was vaccinated with a first, second, and third 2 ml oral dose of rotavirus reassortant vaccine live (human-bovine) on 02-Jul-2007 (Lot# 656845/0409U), 05-Sep-2007 (Lot# 656845/0409U), and 14-Nov-2007 (Lot# 657665/1460U), respectively.  Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, Hib conj vaccine (OMPC) (manufacturer unknown), pneumococcal conj vaccine (unspecified) and influenza virus vaccine (unspecified).  Eleven days later, on 25-Nov-2007 the patient was throwing up what looked like the color of coffee granules and continued to throw up.  The patient's mother called the physician.  On 26-Nov-2007 the patient's mother took the patient to the hospital and was hospitalized.  At the time the patient was experiencing vomiting and had on loose stool.  It was noted that all kinds of tests were performed.  Blood work showed a high white blood count.  The patient was put on IV fluids and was dehydrated.  The patient had an x-ray of the intestine and an ultrasound.  On 28-Nov-2007, at 9:00 a.m., the patient was rushed to a second hospital and was diagnosed with intussusception.  It was noted that all types of tests were performed, and finally a jelly-like mucuos blood stool was expelled.  The patient's mother stated that seven barium enema procedures were performed on the patient, and the last one worked.  There was no surgery.  The patient was discharged from the hospital on 30-Nov-2007 at 12:00 p.m.  The patient's mother indicated that she was nursing the child and he seemed okay, but later started bucking and thrashing like he was in pain.  The patient's mother took the patient back to the hospital and they observed him for several hours and then he was released, not hospitalized.  The patient's mother indicated that the child was recovering but was still somewhat traumatized by all the events and was weak and clinging.  The physician did not think that the patient's intussusception was realted to rotavirus reassortant vaccine live (human-bovine).  No product quality complaint was involved.  No other information was provided.  The patient's intussusception was considered to be an other important medical event.  Additional information has been requested. 1/16/08-records received for DOS 11/28-11/29/07 and 11/29-11/30/07-DC DX: Intussusception. Successful reduction by barium enema. Returned the same evening for C/O crying and vomiting. Observed and discharged. illness began 3 days prior to admission with vomiting, fussy, resless and crying out in sleep. Low grade fever. Emesis became dark brown and guaiac positive. Passed blood mucousy stool.				Y	Y	1			N	11/14/2007	11/26/2007	12	diagnostic laboratory, 11/26?/07, high white blood count; lower GI series X-ray, 11/26?/07; ultrasound, 11/26?/07 1/16/08-records received-successful reduction of intussusception	OTH	OTH			Clavicle fracture; sniffles		WAES0712USA02142	1						1	Asthenia; Barium enema; Dehydration; Enema administration; Haematemesis; Haematochezia; Intussusception; Irritability; Mucous stools; Pain; Ultrasound scan; White blood cell count increased; X-ray; X-ray with contrast lower gastrointestinal tract	DTAP~SANOFI PASTEUR~C2607AA~3~UN~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT2460BA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF192AA~3~UN~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B087028~3~UN~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1460U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0300089	12/17/2007	HI	12.0	12		M	12/01/2007	Fever, Vomit, Malaise, Headache. 12/28/2007 MR received for DOS 12/78/2007 with Final Dx:  Fever of Unknown origin.  2' Dx: Abdominal pain.  Lymphadenopathy.  Pt admitted for w/u of FOU  x 1 month.  Pt developed injection site pain and muscle aches following flu shot.  Pt has developed diffuse body aches, abdominal pain, night sweats, malaise, nausea, vomiting and fatigue.  Pt has been seen multiple times and txd with multiple abx with persistant sx. 5 lb weight loss.  Pt also had 1 week of intermittant L-sided numbness of head, face, neck, chest, arm and fingers. PMH:  none. PE (+) for cervical lymph node swelling. Per consultant- pt may have  mononucleosis picture.				Y	Y	1			Y	11/09/2007	11/09/2007	0	Labs and Diagnostics: CT scan of head, neck, chest, and abdomen (+) for multiple enalrged lymph nodes. Sed rate 46.  CRP 3.2.  Monospot (-). Flu A & B (-).  Rapid strep (-). Na+ 132.  Bicarb 18.	PUB	UNK		None	None		HI0708	1						1	Headache; Malaise; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2461AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0300091	12/17/2007	WA	71.0	71		M	12/17/2007	Patient reports swollen nickel size infection at site of injection									U	10/10/2007				OTH	PVT						1						1	Injection site infection; Injection site swelling	FLU3~SANOFI PASTEUR~U2453AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300092	12/17/2007	CA	41.0	41		F	12/17/2007	Left hand/arm pain - unable to grasp objects, called PMD - on 12/2/07 - advised to use warm compress and take ibuprofen. Visited PMD on 12/3/7. No change in condition. 2nd PMD visit on 12/13/07 - Rx Ibuprofen 600mg BID and 300mg Neurontin TID given by doctor. 1/9/08-records received-12/3/07 seen for C/O left hand very weak and having a hard time picking up things. Impression:peripheral neurtiis. 12/13/07-C/O pain left hand, cramp of fingers. Weakness, numbness and tingling.  1/9/08-non-compliant patient, did not return for follow-up.				Y					U	11/07/2007	12/02/2007	25	Chemistry panel on 12/13/07 1/9/08-records received-C-spine X-ray negative.	UNK	UNK	None	None	None			1						1	Metabolic function test; Pain in extremity	FLU3~SANOFI PASTEUR~U2498AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0300096	12/17/2007	CT	9.0	9		F	12/17/2007	After receiving flu and varicella vaccines pt. stood up and stiffened and fainted and fell to floor. She around almost immediately, color pale. Blood sugar done, p.o. fluids given, rested briefly, discharged home.									Y	12/17/2007	12/17/2007	0	Blood glucose 97	PVT	OTH					CT200722	1						1	Blood glucose; Pallor; Syncope	FLU3~SANOFI PASTEUR~U2473BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1331U~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0300097	12/17/2007	NY	11.0	11		M	12/17/2007	R deltoid w/ exfoliated area 4x6cm, no tenderness/swelling.  Advised to keep clean & observe.									U	12/06/2007	12/12/2007	6		PVT	PVT	None	None	None			1						1	Skin exfoliation	FLU3~SANOFI PASTEUR~U2490AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2540AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B019AA~1~IM~RA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1509U~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0300098	12/17/2007	MI	1.0	1	.0	M	12/12/2007	Rash - belly, back, legs.  Dec. 7th - doctor office.  Hydrocortisone.  Rash and hives on whole body.  Dec. 9th, called doctor.  Doctor called in Zyrtec.									U	11/27/2007	12/07/2007	10		PVT	UNK		Mild cold				1						1	Rash generalised; Urticaria	FLU3~SANOFI PASTEUR~U2513AA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~05276~1~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B54013F~4~UN~UN~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1348U~1~UN~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0300099	12/17/2007	PA	46.0	46		F		Fluvirin vaccine 10/31/07. Several hours later began to have itch, rash to legs, abd, back. Also noted some wheezing. Began to use Benadryl. Was seen by Employee physician who prescribed Allegra and was off work until 11-6-07.				Y					Y	10/31/2007	10/31/2007	0	N/A	PUB	PVT	Protonix; Albuterol MDI	None	PCN Allergy	Rash, Swollen Gland~Rubella (no brand name)~UN~35.00~In Patient		1						1	Pruritus; Rash; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80433~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0300100	12/17/2007	PA	49.0	49		F	11/07/2007	Received Fluvirin vaccine on 10/30/07. Began to experience over entire body itchiness. This was on 11/1/07. On 11/2/07 a raised hive-like rash developed with blisters on (L) arm. Took own Diprolene ointment and advised employee health who advised OTC Benadryl.									Y	10/30/2007	11/01/2007	2	N/A	PUB	PVT		N/A	N/A			1						1	Blister; Pruritus generalised; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80433~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0300101	12/17/2007	CA	80.0	80		F	12/10/2007	about 6 hours after getting a flu shot I experienced a rapid heart beat for about 5 min. I take metoprolol but it didn't help this episode to quit									Y	12/06/2007	12/06/2007	0	I had atrial fibrillation and take warfarin and 25 mg metoprolol once /day p.m.	OTH	UNK	as above (warfarin and 25 mg metoprolol once /day p.m.)	none	as above (I had atrial fibrillation...)	chills, Fever, mucle aches, etc.~Influenza (Seasonal) (no brand name)~1~70.00~In Patient		1						1	Heart rate decreased	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0300102	12/17/2007	NJ	49.0	49		F	12/11/2007	Started 12/4/07 tired & achy, sleepy, weird dizziness, cold sweats, some nausea, no vomiting, some heartburn & LLQ pain, mild cough, occipital HA, lots of gas.									U	12/03/2007	12/07/2007	4		PVT	PVT		some increase abd gas	No			1						1	Abdominal pain lower; Cold sweat; Cough; Dizziness; Dyspepsia; Fatigue; Flatulence; Headache; Nausea; Pain; Somnolence	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA039AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0300104	12/17/2007	KY	0.8			F	12/10/2007	Pt mother called.  Stated pt. was crying, vomiting, had an episode of shakes and was pale.  Advised mother to call MD.  Mom took child to the dr.  Dr. told mother she thought it was a reaction to the vaccine.  Sent her home, later in the evening child had increased vomiting & temp of 103.5.  Went to ER, had IV fluids & suppository to stop vomiting.  Sent home, was doing well on 12/07/07.				Y					Y					PUB	PUB			Hx asthma-chronic wheezing, nebulizer prn, chronic bronchitis			1						1	Body temperature increased; Crying; Pallor; Tremor; Vomiting	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B049AA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U72474EA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB213~2~IM~LL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~B54013F~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0300105	12/17/2007	HI	13.0	13		M	10/23/2007	Pt had hives at injection site.  Pt complained of itching.  Reported adverse effects to health dept.  Pt parents & teacher notified.  If hives worsen pt to report to teacher.									U	10/23/2007	10/23/2007	0		OTH	PUB		None			HI0705	1						1	Injection site urticaria; Pruritus	FLU3~SANOFI PASTEUR~U2461AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0293468	12/18/2007	AZ	13.0	13		F	04/07/2008	Information has been received from a physician concerning a 14 year old female who was vaccinated with a 0.5 mL dose of Gardasil.  Suspect vaccination included Menactra and influenza virus vaccine (unspecified) given on the same date as Gardasil.  On 16-Oct-2007 the patient fainted.  On approximately 18-Oct-2007 couple days later the patient's mother reported that her daughter experienced bilateral knee pain.  The patient's outcome was not reported.  There was no product quality complaint.  Additional information has been requested. Follow up information received on 23-JAN-2008. It was reported that on 16-OCT-2007 at 11:30, immediately following administeration of GARDASIL (lot # 658490/0802U, via IM) the patient a white female weighing 124 pounds and height of 63 inches, stood up and had syncope episode with collapse for seconds. She developed pallor and emesis after. No airway compromise. On 16-OCT-2007 at 11:30 the patient was also vaccinated via IM with a dose of )MENACTRA, lot # U2419AA) and influenza virus vaccine (Sanofi, lot # U2441AA). At the time of vaccination the patient had a mild sore throat and no fever. The patient had a craniosynastosis treated with surgery at 11 month old of age. Laboratory diagnostic test performed included: VS 98.8, blood pressure of 120/64, HR 75, orthostatic P laying 100/62, sitting 100/40 and standing 102/60. The patient was vaccinated at a private doctor's office/hospital and the vaccines were purchsed with private funds. ON an unspecified date, the patient recovered. Additional information is not expected.									Y	10/16/2007	10/16/2007	0	blood pressure, 120/86; diagnostic laboratory, heart rate 75; blood pressure, orthostatic (laying down - 100/62, sitting - 100/60, standing - 102/60): diagnostic laboratory, VS 98.8;	PVT	PVT		Sore throat	Unknown		WAES0711USA00957	1						2	Arthralgia; Immediate post-injection reaction; Pallor; Syncope; Vomiting; Arthralgia; Syncope	FLU3~SANOFI PASTEUR~U2443A~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0802U~1~IM~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~O2419AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|FLU3~SANOFI PASTEUR~U2419AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|HPV4~MERCK & CO. INC.~0802U~1~IM~UN~HPV (GARDASIL)~2|MNQ~SANOFI PASTEUR~U2443AA~1~IM~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~2	USA		Influenza
0299206	12/18/2007	AZ	64.0	64		F	12/14/2007	Extreme pain at time of shot and at entry point.  Much more extreme pain began apx. 6 hrs after shot.  Pain was at site, and radiated down arm, around back and across front of body.  I passed out twice from pain and was then transported to the hospital where 600mg of Tylenol was given, relieving some pain.  Had several tests at the hospital and nothing found.  I returned home after several hours in emergency room.  Was given prescription for Vicodin.  My arm was totally unusable for about a week and I was unable to raise my arm above my shoulder.  In the last 3-4 weeks the pain and mobility of my arm has improved.  I do continue to have pain when raising my arm above my shoulder, but am unable to do several things comfortably.  I also have pain at night.  I believe this was not related to the vaccine, but was totally operator error, as the shot was administered very high on my shoulder - only one finger down from the top.  The shot apparently went into the joint, the bursa, or hit a nerve, or a combination of all these.  I don't know if I will have permanent disability.				Y					U	11/13/2007	11/13/2007	0	Had several tests at the hospital and nothing found.	OTH	PUB	None	None	None	None~ ()~~0.00~In Patient		1						2	Dizziness; Headache; Injected limb mobility decreased; Pain; Syncope; White blood cell count increased; Back pain; Chest pain; Injected limb mobility decreased; Injection site pain; Laboratory test; Loss of consciousness; Pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLA024AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0962W~2~IM~UN~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~~2~UN~LA~PNEUMO (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0300064	12/18/2007	CA	3.0	3		M	12/18/2007	6X6 CM AREA OF LOCAL REDNESS AND TENDERNESS AT VACCINE SITE									Y	11/14/2007	11/15/2007	1		PVT	PVT						1						1	Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U2511AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0495U~2~IM~LA~HEP A (VAQTA)~1	USA		Influenza
0300228	12/18/2007	PR	68.0	68		M	12/18/2007	Patient was admitted to the hospital on 11/25/2007 complaining of ascending progressive bilateral lower extremities weakness.  On 11/27/2007  patient developed respiratory distress that required intubation. Patient is currently on mechanical ventilator by tracheostomy.  3/21/08 Reviewed hospital medical records of 11/25/2007-03/06/2008. FINAL DX: Guillian Barre syndrome; acute respiratory failure.  Records reveal patient experienced progressivly ascending bilateral LE weakness/paralysis & HA w/falls.  Exam revealed SOB, flaccidity & quadriplegia w/absent reflexes & decreased gag reflex.  ICU & mechanical ventilation.  Tx w/IVIG, PEG feeding tube & tracheostomy.  Developed UTI; metabolic encephalopathy; nephropathy; myoclonus; anemia; hypoalbuminemia; hepatic dysfunction; exposure kerato-conjunctivitis; sepsis; mod-severe dysphagia; decubitus ulcers.  Despite aggressive PT, patient remained bedridden at d/c. 1/19/2010 Patient was discharged (transferred) to a skilled nursing facility.					Y	104	Y		N	11/16/2007	11/25/2007	9	11/25/2007 Brain CT-No acute pathology 11/25/2007cold agglutinins-negative  LABS: initial brain CT WNL.  EEG abnormal c/w encephalopathy.  CXR c/w CHF & pleural effusion.  GM1 antibody IgG (+).  Vit B12 957 (H).  ANA (+) 1:80 speckled. EMG/NCS abnormal c/w AIDP.	UNK	UNK			Hypertension, Coronary Artery Disease GERD, hyperlipidemia			1						1	Cold agglutinins negative; Intubation; Mechanical ventilation; Muscular weakness; Respiratory distress; Scan brain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA282EA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0300231	12/18/2007	VA	23.0	23		M	12/18/2007	States he felt congested and feverish prior to flu mist administration.  Temp was taken prior to flu mist was 98.8 by medical rep.  Went to another medical rep for the flu mist administration and answered all questions on the flu mist questionnaire as no.  After being administered the flu mist, states he progressively felt worse until Sunday night about 7 PM, he headed to the ER.  Stated his chest was further congested and he was feeling even more feverish.  At ER, he was diagnosed with an upper respiratory infection and told to go home and drink fluids and rest.  By Tuesday Dec 11th, was feeling better.				Y					Y	12/07/2007	12/09/2007	2	Upper respiratory infection common viral cold.	MIL	MIL		Complained of chest congestion and feeling feverish prior to flu mist administration.	Complained of chest congestion and feeling feverish prior to flu mist administration.			1						1	Nasopharyngitis; Respiratory tract congestion; Upper respiratory tract infection	FLUN3~MEDIMMUNE VACCINES, INC.~500502P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0300235	12/18/2007	UT	53.0	53		F	12/18/2007	Patient had pain at the injection site.									U	10/02/2007	10/02/2007	0		UNK	UNK	Ketoconazole Cream (given on date of vaccination)					1						1	Injection site pain; Medication error; Wrong drug administered	DTAP~SANOFI PASTEUR~C2825AA~UNK~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2436AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300237	12/18/2007	SC	28.0	28		F	12/18/2007	Noticed about one hour after vaccines that she had tiny  blisters on her lips. Not sure if related to vaccines or from stick injury from sewing needle. Needle was found in new garment purchased from store and it was manufactered in another country. Needle stick happened on December 4th, 2007. Relates symptoms could be from stress of the needle stick.									N	12/14/2007	12/14/2007	0		UNK	UNK	None	None	None			1						1	Lip blister	FLU3~SANOFI PASTEUR~U2444AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2862AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0300239	12/18/2007	MI	88.0	88		U	12/18/2007	Client received flu shot after approximately 15 minutes client with c/o I just don't feel very good client pale, b/p 70/50 p 48 rr 16, laid client down raised lower extremities, b/p 80/52 client with history of heart problems, atrial fib and history of heart attack previously, 911 called and client was transported to the hospital and was admitted, and discharged the next day.  12/19/2007 MR received for DOS 12/12-13/2007 with D/C DX:  Near syncope 2' to hypotension and bradycardia. Pt presented to ER after becoming weak and falling to the ground following flu shot. Pt noted to be hypotensive and bradycardic at the time.  Upon arrival in ER pt noted to be in atrial fibrillation with HR in the 30's.  On PE HR noted to be slow and irregular, otherwise WNL.  Meds (Atenolol and Diltiazem) held with good response.   Final DX:  Atrial Fibrillation with bradycardia.					Y	2			Y	12/12/2007	12/12/2007	0	Labs and Diagnostics: EKG-atrial fibrillation w/ slow ventricular response.  CBC WNL.  BMP WNL.	UNK	UNK		history of atrial fib and heart problems	atrial fib and heart problems. PMH:  Atrial Fibrillation, CAD, HTN, OA, hyperlipidemia.  Allergy to Ticlid			1						1	Blood pressure decreased; Heart rate decreased; Malaise; Pallor	FLU3~SANOFI PASTEUR~U2505AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0300245	12/18/2007	OK	1.0	1	.0	F	12/18/2007	t.c. from mom on 12/17/07 with c/o a knot at site of inj.  reports a little redness for a couple of days.  no redness or swelling noted today.  lt deltoid has a small pebble sized knot.									Y	12/11/2007	12/12/2007	1		PUB	UNK	Infants tylenol, motrin, nystatin	NONE	NONE			1						1	Injection site erythema; Injection site mass; Skin nodule	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B049AA~4~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2508AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB181AA~1~IM~LL~HEP A (HAVRIX)~1|HIBV~MERCK & CO. INC.~0677U~3~IM~LA~HIB (PEDVAXHIB)~1|MMRV~MERCK & CO. INC.~0984U~1~SC~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B70143B~4~IM~RA~PNEUMO (PREVNAR)~1	USA		Influenza
0300262	12/18/2007	CA	44.0	44		F	12/18/2007	Developed hives on arms & chest a few hours after getting shot.  Gone in 12-14 hours.  Abdominal cramping & diarrhea 12-14 hours after getting shot.									Y	12/17/2007	12/17/2007	0		OTH	PUB	Ambien CR, Cymbalta, Klonopin, Seraquel	slight cold	depression, anxiety, allergy to Compazine, Reglan			1						1	Abdominal pain; Diarrhoea; Urticaria	FLU3~SANOFI PASTEUR~U2463AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300266	12/18/2007	IN	72.0	72		F	11/16/2007	Pain in shoulders, both knees, hips, could not raise arms.  No fever, no vomiting or diarrhea ongoing.									Y	10/18/2007	10/18/2007	0		OTH	OTH	Aspirin 81 mg	None		~Influenza (Seasonal) (no brand name)~10~0.00~In Patient		1						1	Arthralgia; Joint range of motion decreased; Musculoskeletal pain	FLU3~SANOFI PASTEUR~U2510AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300267	12/18/2007	CA	57.0	57		F	12/10/2007	Patient felt tightness in throat.  No distress except for lump in throat.  Had patient sit for observation.  Patient called her physician.  Advised to give Edipen and Diphenhydramine 50 mg.  Had patient stay 30 min.  No change.  Sent back to work in taxi.  Called next morning.  Patient was fine.										12/07/2007	12/07/2007	0		OTH	PVT						1						1	Throat tightness	FLU3~SANOFI PASTEUR~U2509AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300268	12/18/2007	WI	1.2	1	.2	F	12/10/2007	At 3pm client started to vomit every 15 mins until 6:30pm.  Mom gave child Tylenol at 1:30 for discomfort from the DTaP vaccine.  Mom gave infant Pedialyte at 11pm when she woke up, but she vomited the Pedialyte up in 15 mins.  When child woke up at 8:30am she was better, no more vomiting.									Y	12/10/2007	12/10/2007	0		PUB	PUB		no	none			1						1	Discomfort; Vomiting	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B046AA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2473HA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB211AA~2~IM~RL~HEP A (HAVRIX)~1	USA		Influenza
0300269	12/18/2007	NM	75.0	75		M	12/12/2007	chills, myalgias, (L) arm swelling x 24 hrs; stiff neck persisting until present time (12/12/07 0800). Pt instructed to RTc no improving or worsening myalgia; ok to take ibuprofen prn				Y					N	12/10/2007	12/10/2007	0		PUB	OTH	Lisinopril 40 mg po qday	none	All PCN			1						1	Chills; Musculoskeletal stiffness; Myalgia; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78994~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1035F~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0300270	12/18/2007	WI	68.0	68		M	10/23/2007	Shot on Tue-Oct. 9 approx. 11:30 am; next morning weakness (10-10-07), achy muscles, H/A, fever 101 deg, chills, denies chest congetion, c/o head congestion, fatigue, diarrhea started 10/15/07 with abd cramps. Began to feel better on 10/20/07.									Y	10/09/2007	10/10/2007	1	None	PUB	PUB	HTN, Asthma, Cymbalta, GERD, Walptin (allergy)	None	None			1						1	Abdominal pain; Asthenia; Diarrhoea; Fatigue; Headache; Myalgia; Pyrexia; Respiratory tract congestion	FLU3~SANOFI PASTEUR~U2445AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300272	12/18/2007	WA	8.0	8		M	12/12/2007	Urticaria				Y					Y	12/01/2007	12/08/2007	7		PVT	PUB	Zantac		monotype dystrophy			1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80256~7+~IM~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARCEL~MERCK & CO. INC.~1252U~2~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0300274	12/18/2007	OH	41.0	41		F	12/12/2007	Afternoon on 12-8-07 approx 2:00 pm. lt. arm (deltoid) where flu vaccination given became sore and aching-Difficulty with raising arm it increase pain when sleeping on lt. shoulder at night-										11/27/2007	12/08/2007	11		PUB	PUB		None	Hypothyroid			1						1	Injected limb mobility decreased; Injection site pain; Pain in extremity	FLU3~SANOFI PASTEUR~2527AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300275	12/18/2007	AL	66.0	66		F	12/10/2007	Pt. reports redness and swelling of (R) arm, pm of 12/6/07. Following am observed hives at (R) shoulder, pain, radiating across back and ribs. Tx=otc Benadryl, Pepcid, Prednisone				Y					Y	12/06/2007	12/06/2007	0	None	PVT	OTH	Ambien; Zithromax; Glycolax; Proair HFA; Celebrex; Hyoscyamine	None	ASA/Acetaminophen/Caffine/Potassium; Vicodin; PCN; Erythromycin; codeine; Perocet; Darvocet; Novacain; Tegretol; Betadine; Morphine; Tape 1 adhesive;Keflex; NSAIDS; Feldene; Methadone; Trimethoprim-sulfamethoxazole; Bipolar disorder; insomnia; hyperlipidemia; myalgia; asthma; emphysema; reflux			1						1	Erythema; Oedema peripheral; Pain; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA319AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~21FEB09~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0300276	12/18/2007	RI	50.0	50		F	12/10/2007	12x12cm bruise with central cluster of petechiae.				Y					U	12/06/2007	12/07/2007	1		PUB	PUB	MiraLax, ASA, Lisinopril, Simvastatin, Celexa, trazodone	None	Hyperlipidemia, depression, gastritis			1						1	Contusion; Petechiae	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AF11A026AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0300277	12/18/2007	OR	4.0	4		F	12/04/2007	3 days after influenza vaccine 7am, red, itchy flare around site, some swelling.									Y	12/01/2007	12/04/2007	3		PVT	PVT	No	No	None			1						1	Injection site erythema; Injection site pruritus; Swelling	FLU3~SANOFI PASTEUR~U2478EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300278	12/18/2007	AL	0.6	0	.6	F	12/06/2007	3cm x 2cm erythematous tender site around injection site of right lateral thigh.									Y	12/04/2007	12/05/2007	1	None	PVT	PUB	None	None	None	none~ ()~~0.00~In Patient|none~ ()~~0.00~In Sibling|none~ ()~~0.00~In Sibling		1						1	Injection site erythema; Injection site pain	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B097AB~UNK~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2473HA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0077U~UNK~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B53981A~UNK~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0979F~UNK~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0300279	12/18/2007	AR	16.0	16		F	12/10/2007	Patient complained of getting knot and red itchy area down left arm.  This started on Friday, 12-7-07.  Patient was given Benadryl 25mg  and PO OTCq 4 hours for itching and Dexamethasone 4mg IM to right UOQG was given.									U	12/07/2007	12/07/2007	0	Unknown	PVT	PUB	None	None	None			1						1	Erythema; Pruritus; Skin nodule	FLU3~SANOFI PASTEUR~U2514AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0802U~UNK~IM~~HPV (GARDASIL)~1	USA		Influenza
0300281	12/18/2007	CO	21.0			F	12/11/2007	10/22/07 - received influenza vaccine 11/19/07 - presented with right shoulder pain and weakness for 24 hours									U				None	PVT	PVT	None	None	None			1						1	Asthenia; Musculoskeletal pain	FLU3~SANOFI PASTEUR~U2439AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300283	12/18/2007	CA	10.0	10		M	12/14/2007	Day after shot complained of itching, burning.  Mom noted large swollen area that night.  I see area 4 1/2 long by 4 at widest tapering to 3 at bottom.  Area raised, hot on posteria left upper arm.  Patient given Tylenol and aloe cream for itching.				Y					Y	12/12/2007	12/13/2007	1	None	PVT	UNK	None	None	None			1						1	Burning sensation; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U2515AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1498U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0300285	12/18/2007	PA	33.0	33		F	12/12/2007	Received flu shot L delt. on 11/15.  Seen in office 12/4 for L forearm pain with numbness, tingling, and swelling per her report.  States she can not move her arm at all.  Per MD-exam shows no swelling or bony abnormality.  MD does not feel this is in any way related to her flu shot.									U	11/15/2007				PVT	PVT	naprosyn	none	LBP, major depression			1						1	Hypoaesthesia; Injected limb mobility decreased; Paraesthesia; Swelling	FLU3~SANOFI PASTEUR~U2490AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300287	12/18/2007	WI	27.0	27		M	11/26/2007	On the evening of the vaccine administration, patient developed a raised quarter-size area over the injection site.  Overnight, his deltoid began to swell.  When seen 11/23, there was an orange circle surrounding the injection site.  It was no longer raised, but the entire deltoid was swollen, warm to the touch, and painful.  Rx ibuprofen and cold compressing.									Y	11/21/2007	11/21/2007	0		OTH	OTH	Spectazole ointment and Bactrim DS (not started)	Lt. buttock boil-Coag & Staph	NKA, HIV	none~ ()~~0.00~In Patient|none~ ()~~0.00~In Sibling|none~ ()~~0.00~In Sibling		1						1	Injection site swelling; Oedema peripheral; Pain; Skin warm	FLU3~SANOFI PASTEUR~U2530AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300288	12/18/2007	WI	30.0	30		F	12/10/2007	Nausea and vomiting starting 12/8/07 in morning.  Also, diarrhea, abdominal cramping, aches and low grade fever.  No respiratory symptoms.									Y	12/07/2007	12/08/2007	1		UNK	UNK						1						1	Abdominal pain; Diarrhoea; Nausea; Pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~C2511AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300292	12/18/2007	NC	1.2	1	.2	F	12/06/2007	Patient received vaccines and then 1 hour later started with itching and red lesions on neck, chest and abdomen.  The rash appeared as a wheal with lots of itching.  Patient was treated with Prelone.									Y	11/15/2007	11/15/2007	0		PVT	OTH	None	None	None		NC07126	1						1	Erythema; Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U2508AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB163AB~1~~~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0284U~1~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1335U~1~~~VARICELLA (VARIVAX)~1	USA		Influenza
0300295	12/18/2007	NC	24.0	24		M	12/17/2007	Rash all over torso x3 days after getting vaccine. Smallpox vaccine, This is the immunization that I had a reaction to. Red spots on abdomin and arm.				Y					Y	12/14/2007	12/17/2007	3		MIL	MIL		None				1						1	Rash	ANTH~EMERGENT BIOSOLUTIONS~FAV158~1~SC~UN~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~U2516AA~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TYP~SANOFI PASTEUR~A02212~1~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0300296	12/18/2007	NC	20.0	20		M	12/10/2007	Generalized vaccinia upper chest/back.  Occurred 10 days post vaccine.  No Rx.									Y	11/27/2007	12/08/2007	11		MIL	MIL			None			1						1	Vaccinia	ANTH~EMERGENT BIOSOLUTIONS~FAV158~1~SC~UN~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~U2516AA~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TYP~SANOFI PASTEUR~A02212~UNK~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0300308	12/18/2007	NC	0.6	0	.6	M	12/01/2007	Seizure like event.  A series of quick myoclonic jerks=extension of neck, stiffening of arms & legs about 8 times in sequence over 1-2 minutes.  Repeated again 8 times at home, to ED, 8 more times in ED then no more.  No post vital lethargy, no mental status changes, no fever.  (Suspected DTaP reaction).				Y					Y	11/29/2007	11/30/2007	1	BMP, CBC normal, negative EEG, negative CT	PVT	PVT		None	None		NC07127	1						1	Computerised tomogram normal; Convulsion; Electroencephalogram normal; Full blood count; Laboratory test normal; Musculoskeletal stiffness; Myoclonus	DTAP~SANOFI PASTEUR~U2290AA~3~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT247UAA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0570U~3~IM~RL~HEP B (RECOMBIVAX HB)~1|IPV~SANOFI PASTEUR~Z08732~3~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~B540090~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0300311	12/18/2007	MI	0.4	0	.4	F	12/18/2007	No adverse event occurred.  Influenza vaccine given at 4 months of age.										11/06/2007				PVT	PUB	None	None				1						1	Inappropriate schedule of drug administration	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B115DB~2~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2456ZA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0064U~2~IM~RL~HIB (PEDVAXHIB)~1|RV5~MERCK & CO. INC.~0507U~2~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0300314	12/18/2007	WI	9.0	9		F	12/14/2007	Back ache, sore on mouth, sneezing, crusted blood in nasal passages.									Y	11/16/2007	11/17/2007	1		PUB	PUB			Sulfa allergy			1						1	Back pain; Mouth ulceration; Sneezing	FLU3~SANOFI PASTEUR~U2523AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300315	12/18/2007	ND	50.0	50		F	12/10/2007	Soreness in arm after vaccine administered; soreness spread across chest at approx 2000. Awakened at 2200 with heavy/crushing midsternal chest pain with radiation to neck & both arms.  Relieved after approx 30-40 mins (took Tyl).									Y	11/14/2007	11/14/2007	0		PUB	UNK	None	None	None			1						1	Chest pain; Neck pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2494AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300317	12/18/2007	WA	8.0	8		F	12/11/2007	2 hrs after flu shot hives, no respiratory Sx, no Hx egg allergy; Benadryl.									Y	12/07/2007	12/07/2007	0	None	PVT	PUB	None	None	None			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2508AA~6~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300318	12/18/2007	WI	1.6	1	.6	M		Given Pediatrix, DTaP-HepB-IVP combined, when she should have received DTaP alone.  No excessive symptoms noted by mom.  I will not give DTaP at this time, but will give routine 5 yo vacc.  Mom aware.									Y	10/18/2007			None	OTH	UNK		None	Allergy: liquid amoxicillin	None~ ()~~0.00~In Patient|None~ ()~~0.00~In Sibling|None~ ()~~0.00~In Sibling		1						1	Wrong drug administered	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B096BA~UNK~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2460EA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300319	12/18/2007	MN	80.0	80		F	10/16/2007	1-2 hours after getting Pneumovax pt. experienced soreness up & down arm & neck, began to itch.  Pt woke at 4AM w/ fever symptoms (chilled & shakes) but no temp taken.  Upon recommendation of RPH applied ice & resolving after 3 days later.  Now itches like healing sore up and down arm.  Hurts to scratch but no loss of functionability.									Y	10/10/2007	10/10/2007	0		PUB	UNK	Fosamax, Ursodiol		Penicillin & hay fever/ragweed			1						1	Chills; Neck pain; Pain in extremity; Pruritus; Tremor	FLU3~SANOFI PASTEUR~U2450AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0300321	12/18/2007	FL	2.0	2	.1	M	12/06/2007	4x4 1/2 Child has red, swollen right anterior thigh, no fever, is playful and happy; since 10:00 this morning, no shortness of breath.				Y						12/04/2007	12/06/2007	2		PVT	PUB		None				1						1	Injection site swelling	FLU3~SANOFI PASTEUR~UT2474AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB181AA~1~IM~RL~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0300533	12/18/2007	PA	15.0	15		F	12/14/2007	Information has been received from a registered nurse concerning a 15 year old female with penicillin allergy who on 26-JUL-2007 was vaccinated with the first dose of Gardasil (Lot #658094/0524U).  On 12-OCT-2007, she was vaccinated intramuscularly in unspecified deltoid muscle with the second dose of Gardasil (Lot #659435/1265U).  Concomitant therapy included influenza virus vaccine (unspecified).  On 12-OCT-2007, the patient fainted after receiving the second Gardasil vaccine.  On 30-OCT-2007, the patient was examined by the physician because of four more episodes of fainting (no previous history of fainting before the 12-OCT-2007 episode).  Laboratory work on 30-OCT-2007 for a complete blood count, iron level and a metabolic panel was within normal limits (levels unspecified).  An electrocardiogram did not show any abnormalities.  The patient's experience persisted.  Additional information has been requested.				Y					N	10/12/2007	10/12/2007	0	diagnostic laboratory, 10/30/07, WNL, metabolic panel; electrocardiogram, 10/30/07, no abnormalities; complete blood cell, 10/30/07, WNL; serum iron assay, 10/30/07, WNL	UNK	UNK		Penicillin allergy			WAES0711USA00643	1						1	Blood iron normal; Electrocardiogram normal; Full blood count normal; Laboratory test; Metabolic function test; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~1265U~2~IM~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0300667	12/18/2007	NY	20.0	20		F	12/14/2007	Information has been received from a health professional concerning a 20 year old female with a history of drug hypersensitivity to Erythromycin who on 26-JUL-2007 was vaccinated intramuscularly with her first dose of Gardasil (Lot #657006/0188U).  Concomitant therapy included influenza virus vaccine (unspecified), venlafaxine HCl (Effexor) and ethinyl estradiol/norgestimate (Ortho Tri-Cyclen).  On 26-JUL-2007 the patient experienced pain at injection site.  The patient sought unspecified medical treatment while at the office.  On 06-NOV-2007 the patient was intramuscularly vaccinated with the second dose of Gardasil (Lot #659437/1266U) and experienced pain at the injection site.  Subsequently, the patient recovered from the pain at the injection site.  Additional information has been requested.  This is one of several reports received from the same source. This is in follow-up to report (s) previously submitted on 12/14/2007.				Y					Y	07/26/2007	07/26/2007	0	None	OTH	OTH	Ortho Tri-Cyclen, Effexor		Drug hypersensitivity		WAES0711USA01336	1						1	Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~0188U~1~IM~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0300849	12/18/2007	IL	12.0	12		F	04/07/2008	Information has been received from a consumer concerning her 12 year old daughter with asthma who was vaccinated with her first dose of Gardasil via injection. Concomitant therapy included influenza virus vaccine (unspecified). The mother reported that two to three hours after her daughter received the vaccine she developed signs of asthma which included wheezing. The patient was treated with a nebulizer. The wheezing continued for two to three days and then ceased. The mother mentioned that her daughter had a history of asthma, however, she had not had an asthmatic episode in a while. The patient also received a flu vaccine the same day (unspecified). Additional information has been requested. This is in follow-up to report(s) previously on 12/14/2007. Information has been received from a consumer concerning her 12 year old daughter with asthma who was vaccinated with her first dose of GARDASIL (Lot #658222/0827U) intramuscularly in the left arm. Concomitant therapy included influenza virus vaccine (Lot #U2452AA) intramuscularly in the right arm. The mother reported that two to three hours after her daughter received the vaccine she developed signs of asthma which included wheezing and coughing. The patient was treated with a nebulizer, an inhaler, and 2 courses of oral steroids. The wheezing continued for two to three days and then ceased. The patient is now better but she is still coughing. The mother mentioned that her daughter had a history of asthma.However, she had not had an asthmatic episode in over 2 years. The patient also received a flu vaccine the same day (unspecified).				Y					N	11/10/2007	11/10/2007	0	Unknown	PVT	PVT	oral steroids	Asthma			WAES0711USA03619	1						1	Asthma; Wheezing	FLU3~SANOFI PASTEUR~U2452AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0927U~1~IM~LA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0300888	12/18/2007		13.0	13		F	12/14/2007	Information has been received from a nurse concerning a 13 year old female who on 19-Nov-2007 was vaccinated with her first dose of Gardasil (Lot #656371/0181U).  Concomitant therapy included influenza virus vaccine (unspecified).  On 19-Nov-2007 the patient fainted.  Subsequently, the patient recovered from fainting.  Additional information has been requested. Information has been received from a nurse concerning a 13 year old female who on 19-NOV-2007 was vaccinated intramuscularly in the right deltoid with her first dose of HPV (lot # 656371/0181U).  On 19-NOV-2007 the patient fainted within 2 minutes of receiving the HPV vaccine. Follow up information reported that after receiving both immunizations, the patient suddenly said I can't see and collapsed to the floor froma standing position. She was unconscious for 5 - 10 seconds and then opened her eyes and asked what happened. The nurse kept her on the floor and gave her soda to drink. The patient was weak, shaky, pale, diaphoretic, and nauseous for approximately 10 -to 15 minuts. On 19-NOV-2007, the patient experienced a full recovery from fainting. And being weak, pale, diaphoretic, shak, and nauseous.									Y	11/19/2007	11/19/2007	0	Unknown	OTH	OTH			Unknown		WAES0711USA04141	1						1	Asthenia; Hyperhidrosis; Loss of consciousness; Nausea; Pallor; Syncope; Syncope; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~0181U~1~UN~UN~HPV (GARDASIL)~1	USA		Influenza
0300899	12/18/2007	PA	15.0			F	12/14/2007	Information has been received from a physician concerning a 15 year old female who was vaccinated (route, site and dosage not reported) with Gardasil (lot # not reported).  Concomitant therapy included Menactra, Flumist and Adacel given on the same day.  Post vaccination, the patient stood up and started talking and subsequently fainted.  The patient fully recovered.  Additional information has been requested. Information has been received from a physician and follow-up information from a nurse concerning a 15 year old female with no relevant  medical hisotry, known drug allergies or illnesses at time of vaccination who in 17-NOV-2007, at 11:00 am was vaccinated intramuscularly in the deltoid muscle of the upper left arm with the first 0.5ml dose of HPV vaccine (lot # 658283/0929U). The patient was concomintantly vaccinated with MENACTRA (Lot #62403AA) given intramuscularly in the deltoid muscle of the lower left arm, FLUMIST (Lot #500489P) given intranansally and ALACEL (lot #C2771AA) given intramuscularly in the deltoid muscle of the right arm. The patient fainted post vaccinations. At 11:10 am the patient stood up walked over to the other side of the room and was talking with her family and fell over, hitting her head on top of a chair. The patient was faced down on the ground for approx 30 seconds. The patient came to and started talking. The CNNP came in to the room immediately and gave the patient some water and ice pack for the red area on her forehead. The patient's mother was instructed to watch patient carefully for 48-72 hours. The reporter stated that if the patient started to vomit, get a severe headache, sleeping too much the patient should go to the emergency rooml. No lab diagnostic test were performed. The patient left the office and was fine. The patient fully recovered. No additional information is expected.									Y				Unknown	OTH	OTH	Unknown		Unknown		WAES0711USA04347	1						1	Fall; Head injury; Headache; Hypersomnia; Syncope; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~~UNK~UN~UN~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~~UNK~UN~UN~TDAP (ADACEL)~1	USA		Influenza
0301214	12/18/2007					F	12/14/2007	Information has been received from a health professional concerning a 11 or 12 year old female who in November 2007, was vaccinated with her first dose of Gardasil vaccine. Concomitant therapy included influenza virus vaccine (unspecified). In November 2007, the patient experienced pain at the injection site going from her shoulder to her neck and ear almost immediately after getting the shot. That same night the patient also experienced a fever of 104 Fahrenheit. Subsequently, the patient recovered from pain at the injection site and a fever of 104 Fahrenheit. The patient sought medical attention the next day in the office and the doctor gave her Motrin. Information has been received from a healthcare professional concerning a 12 year old female who on 06-NOV-207, was vaccinated with her first dose of HPV vaccine (lot # 639435/1265U). On 06-NOV-2007, within 2 -3 minutes of receiving HPV vaccine, the patient exprienced pain at the injection site going from her shoulder to her neck and ear almost immediately after getting the shot. That same night the patient also experienced a fever of 104 F with a headache and back pain. Subsequently, the patient  recovered from pain at the injection site and a fever of 104 F. The patient sought medical attention the next day in the office and the doctor gave her (MOTRIN).									Y	11/01/2007	11/01/2007	0	Unknown	OTH	OTH			Unknown		WAES0711USA04725	1						1	Back pain; Ear pain; Immediate post-injection reaction; Injection site pain; Musculoskeletal pain; Neck pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~1~IM~~HPV (GARDASIL)~1	USA		Influenza
0301219	12/18/2007	VA	15.0			F	12/14/2007	Information has been received from a nurse concerning a (approx) 15 year old female who was vaccinated (date, route and site not reported) with the 1st dose of GARDASIL vaccine (yeast) (lot # not reported). Concomitant therapy included influenza virus vaccine (manufacturer unknown). The patient complained of numbness in her hands and feet after receiving GARDASIL vaccine (yeast). The patient reported that the numbness  was on and off. Patient received unspecified medical attention. At the time of this report,  patient's outcome was unknown. Additional information has been requested. Information has been received from a physician concerning a 15 year old female patient who on 20-NOV-2007, was vaccinated IM in to the left deltoid with a first dose of HPV vaccince. On 21-NOV-2007 one day after the vaccination, the patient experienced intermittent numbness and tingling in her hands and feet. It was reported that it would last a few minutes and it occurred 4 to 5 times per day. The patient then went on to develop a cough and cold. On 26-NOV-2007, the patient was daignosed with mononucleosis. Laboratory disgnostic studies performed included serum Epstein-Barr virus early antigen immunoglobulin M antinbody test and serum Epstein-Barr capsid antigen immunoglobulin G antibody test which were reported as positive. Within 5 days, the patient recovered from intermittent numbness in hands and feet. Subsequently, the patient recovered from mononucleosis, cough and cold. No product quality complaint was involved.									U				Unknown	OTH	OTH			Unknown		WAES0711USA04772	1						1	Cough; Epstein-Barr virus antibody positive; Epstein-Barr virus antigen positive; Hypoaesthesia; Mononucleosis syndrome; Nasopharyngitis; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~1~UN~UN~HPV (GARDASIL)~1	USA		Influenza
0301329	12/18/2007	CA	17.0			F	12/14/2007	Information has been received from a physician concerning a 17 year old female who on 24-SEP-2007 was vaccinated with her first dose of GARDASIL vaccine (yeast). The patient developed erythema nodosum on her legs which lasted for over one month. On 23-Nov-2007, the patient received her second dose of GARDASIL vaccine (yeast). Subsequently the patient experienced erythema nodosum on her legs again. The patient received the influenza virus vaccine (unspecified) (INFLUENZA VIRUS VACCINE USP) on 22-Oct-2007. The patient sought unspecified medical treatment in the office. No treatment required for either AE. The patient's erythema nodosum persisted. Additional information has been requested. Information has been received from a physician concerning a 17 year old female who on 24-SEP-2007 was vaccinated with her first dose of HPV vaccine. The patient developed erythema nodosum on her legs which lasted for over one month. On 23-Nov-2007, the patient received her second dose of HPV vaccine (lot # 658560/1062U) IM in the left deltoid. Subsequemtly the patient experienced erythema nodosum on her legs again. The patient received the influenza virus vaccine (unspecified) on 22-Oct-2007. The patient sought unspecified medical treatment in the office. No treatment required for eith AE. The patient's erythema nodisum persisted. Follow-up information was received from the physician. Illness at the time of vaccination was erythema nodosum. Bruises on lower legs with erythema nodosum on the exam. The patient reported getting lesions in October 2007, one month post first HPV vaccine dose. The patient was seen in November 2007 and was given a second dose of HPV vaccine. The patient reported worsening/increase in lesions after the second dose. A complete blood cell count prothrombin time and activated partial thromboplastin was performed and were normal. On an unspecified date the patient recovered as per telephone conversation 19-DEC-2007. Additional information is not expected.				Y					N	09/24/2007	09/24/2007	0	Unknown	OTH	OTH			Unknown		WAES0711USA06646	1						1	Activated partial thromboplastin time normal; Contusion; Erythema nodosum; Full blood count normal; Skin lesion	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~2~UN~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0301336	12/18/2007	SC	15.0	15		F	12/14/2007	Information has been received from a health professional concerning a 15 year old female with a history of attention deficit disorder and sickle cell disease who in September 2007, was vaccinated with her first dose of Gardasil. Concomitant therapy included STRATTERA and FLUVIRIN(unspecified). On 27-NOV-2007 the patient was vaccinated intramuscularly with her second dose of Gardasil. A few hours post dose two, the patient experienced many, small, slightly raised, itchy bumps on both arms. Subsequently, the patient recovered from many, small, slightly raised, itchy bumps on both arms after she was given 50mg of over the counter BENADRYL. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Information has been received from a health professional concerning a black 15 year old female with a history of attention deficit disorder and sickle cell disease who in September 2007, was vaccinated with her dose of GARDASIL. Concomitant therapy included STRATTERA. On 27-NOV-2007 the patient was vaccinated intramuscularly in the left deltoid with her second dose of GARDASIL (lot# 98219/0680U). Concomitant therapy included FLUVIRIN intramuscularly in the right deltoid (lot# 80432). A few hours post dose two, the patient experienced many, small, slightly raised, itchy bumps on both arms. Subsequently, the patient recovered from many, small, slightly raised, itchy bumps on both arms after she was given 50 mg of over the counter BENADRYL.									Y	11/27/2007	11/27/2007	0	Unknown	PVT	PVT	STRATTERA		Attention deficit disorder; Sickle cell disease		WAES0712USA00172	1						1	Attention deficit/hyperactivity disorder; Rash papular; Rash pruritic; Sickle cell anaemia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80432~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HPV4~MERCK & CO. INC.~0680U~2~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0295526	12/19/2007		11.0			F	12/14/2007	Initial report received on 10 December 2007 from another manufacturer, report# WAES 0712USA01240, The initial reporter to this manufacturer had been the FDA. Verbatim from the report: Information has been received from the FDA through the Freedom of Information Act concerning a 11 year old female with no medical history or pre-existing illnesses who on 19-OCT-2007 was vaccinated in the left arm (route not reported) with the 1st dose of Gardasil (lot# 65503/0012U). The patient was concomitantly vaccination with Varivax (lot# 656691/0127U) in the left arm, influenza virus vaccine (unspecified) (lot# U2435AA) in the left arm, BOOSTRIX (lot#AC52B013AA) in the left arm and MENACTRA (lot# U2208AA) in the left arm. On 27-OCT-2007, approximately 2 weeks after vaccine administration, the patient developed ataxia, headache and seizures requiring antiepileptics, steroids and antibiotics. The patient was hospitalized. It is unknown if patient recovered. The VAERS ID number is 295526. No additional information is expected.					Y	0		Y	U	10/19/2007	10/27/2007	8	Unknown	UNK	UNK			The patient had no medical history or pre-existing illness at the time of vaccination.  It was unknown if the patient had been receiving any concomitant medications.		200704226	1						2	Ataxia; Convulsion; Headache; Ataxia; Convulsion; Headache	FLU3~SANOFI PASTEUR~U2435AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0012U~1~~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2208AA~1~~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B013AA~6~~LA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~0127U~2~~LA~VARICELLA (VARIVAX)~1|FLU3~SANOFI PASTEUR~U2435AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|HPV4~MERCK & CO. INC.~0012U~1~UN~LA~HPV (GARDASIL)~2|MNQ~SANOFI PASTEUR~U2208AA~1~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B013AA~6~UN~LA~TDAP (BOOSTRIX)~2|VARCEL~MERCK & CO. INC.~0127U~2~UN~LA~VARICELLA (VARIVAX)~2	USA	Hospitalisation,Disabling	Influenza
0300249	12/19/2007	GA	37.0	37		F	12/18/2007	I received the flu shot October 8, 2007.  As each day passed after the shot, I began feeling worse and worse.  On October 15th, I contacted my Allergist to get antibiotics for what I believed was a sinus infection.  He prescribed Levaquin.  I continued to feel worse and worse, even while on antibiotics.  By October 18th, I woke up with a rash on my neck and chest.  I went in and saw Dr. so she could check out the rash on my neck and chest, and she wondered at that time if it was a reaction to the levaquin (my allergist was out of the office that day, so I could not consult with him).  I was also having fever and chills, weakness, a lot of coughing, extreme nasal congestion, headaches, dizziness, difficulty breathing, and tremors.  I was also white as a ghost, but my face kept flushing red.  I have taken levaquin many times before without incident, so I did not believe that was the problem.  I stopped the levaquin at Dr. instruction anyway, and she changed my antibiotic to Zithromax.  The rash subsided a little bit over the next couple of days, but I still kept feeling worse and worse, even with the change of antibiotic.  I was still having all of the symptoms I mentioned previously, but they were getting worse.  By around October 23rd or 24th, I was feeling so bad that I called my allergist to see if he could help me.  He had me come into the office for an exam.  I think he was surprised at the shape I was in.  I told him about all of the symptoms I was having, and he did a check.  He said everything looked inflamed, my nose etc., and he said even my ears were red and inflamed.  It was evident I was very ill, and he even questioned if I should drive home.  On top of all of the other symptoms I had been having, I was progressively more weak and dizzy which worried my allergist.  He gave me a shot of antibiotics and a shot of steriods right then, and he prescribed doxycycline, rest and fluids.  I did as I was instructed, but I still was not getting any better.  At some point in the middle of all of this, I was prescribed steriods as well, but I cannot remember exactly when.  I kept trying to work during all of this, but I became so sick that I was unable to work, and I am still unable to work.  I saw Dr. and my allergist again during this period, and there wasn't a lot done.  They were not sure what was going on and why I continued to keep getting sick.  During this time my allergist prescribed a round of avelox, which did not help me at all either.  My allergist did some blood work, but I am not sure of exactly what the results were then.  I still continued to try to work during this time, but I was just absolutely unable to work.  Around the first of November, I went to the urgent care clinic because I was feeling so horrible.  Dr. and my allergist didn't seem to know what to do for me, but I was desperate because of how bad I continued to feel.  The urgent care clinic took down my symptoms and checked my blood pressure and pulse rate.  The doctor came in and was very concerned because my pulse rate was 134.  I told him about all of the headaches, sinus problems, coughing and chest pain, etc. etc., and he decided to immediately do an EKG to be sure my heart had a stable rhythm.  He asked me how long my heart had been racing like it was, and I told him it had been going on since the beginning of October.  He was absolutely shocked, and proceeded with the EKG.  He said my heart rhythm was stable, but my pulse was very, very fast.  I told him that it had become increasing difficult for me to breathe over the weeks, and that I just felt horrible.  He had the nurse check my oxygen saturation, which was around 96 or 97%.  He said that wasn't bad, but at my age it should be 100%.  He did some blood work and said my red and white blood count was elevated, and he also did a chest x-ray.  He diagnosed me with the sinus infection and bronchitis, and he said that the tubes in my chest were in spasms.  He said the most important thing was to protect my lungs, so he gave me Omnicef and Azmacort for my lungs.  He also prescribed cough medicine to help with the cough and chest pain.  He wasn't sure where the tremors were coming from, but he hoped the medication would help me get well.  As the week continued, I was not getting any better at all, and my tremors were so bad that my entire body hurt from shaking.  I went back to the urgent care clinic that Saturday (around Nov. 10th), and the doctor gave me another shot of steriods, another 10 days of Omnicef, and a different cough medicine.  He told me to check in with my regular doctor if I continued to be sick.  I continued to be very ill, and none of the medication was helping me at all.  Dr. and my allergist kept sending me back and forth, and they just kept telling me to wait it out.  I saw Dr. again on November 26 because I was breaking out in the red splotches again.  I kept having these splotches throughout this whole ordeal.  She finally said she thought I was getting hives, and she sent me to a dermatologist to get it checked out.  I went to the dermatologist on November 27, and she confirmed the hive diagnosis.  She gave me cream for the splotches, allegra, and a liquid antihistimine to take at bedtime.  I told the dermatologist about all I had been through since October, and since I was still having trouble breathing she prescribed an EPI pen for me to keep with me in case I needed it.  She told me she had seen a lot of weird reactions in her time as a dermatologist, and she felt that something in the flu shot could have set off this cascade of symptoms and illnesses.  She said this fact was strengthened by the fact that I had reactions to immunizations as an infant, so I did not get the regular schedule of immunizations when I was a baby.  She said that there could have been a preservative or something that I am allergic to in the flu shot, so she felt strongly that I should be seen by an allergist in town that had once worked in the clinic.  Her office called the allergist in town, and they made an appointment for me Dec. 7th.  After I saw the dermatologist, I saw the ENT on Nov 28th.  This was an ENT I had seen before, and he was shocked at my condition.  He took my history of what had been going on, he looked at my sinuses as much as he could in the office, and he sent me for blood work and a CAT scan of my sinuses.  He took a culture of the green mucus in my nose as well.  He also referred me to a neurologist because my tremors were so bad.  He didn't change any of my meds because he wanted to get the test results first.  On Nov. 29th I saw the neurologist.  They did a full check of me and the tremors I am still having.  The neurologist said the tremors were not a Parkinson's type tremor which was good, but he was not exactly sure what was causing the tremors.  He prescribed Clonazepam for the tremors to try to help make me more comfortable--my body hurt so badly from the constant shaking.  I still have to go for a follow up soon.  On Dec. 7th I saw the allergist in Athens that the dermatologist wanted me to see.  I was in his office for hours, and he did extensive blood work, allergy testing, I blew into a machine, and he took my history of what had been going on.  He could definitely see how sick I still was, and he told me that if I were him I should forgo the flu shot in the future.  I told him that that would be no problem, and that I had already decided that I will never get another flu shot because I firmly believe the flu shot is what caused all of these problems.  I went from healthy to deathly ill overnight--the flu shot was the difference.  The allergist cut down my medications to only the ones that were necessary, and prescribed meds for the hives, an inhaler for my cough and chest pain, and Wilson's solution for my sinuses.  He also told me my pulse rate was high, I was dehydrated, and that I should drink a lot of fluids, which I have been doing.  On Dec. 10th, the ENT called to tell me that my sinus CAT scan looked clear, the tests for Lyme and a few other weird things came back normal, my culture didn't have any weird bacteria, but my white count was still high.  I went to see my regular allergist that day as well, and he also did an exam.  I told him everything I had been through over the last months, and he could definitely tell that I am still very sick.  My regular allergist is now going to put me on 6 months of IVIG to see if it will boost my immune system to get rid of all of these symptoms I am still having.  I saw the allergist again on Dec. 17th, and he said I still had a ways to go but to hang in there.  He agreed that we will see if the IVIG will help boost my immune system to fight all of these symptoms.  The IVIG was approved, and I start that this weekend.  I am going for a re-check with the neurologist on Dec. 19th, with more follow-up appointments in January.  I don't remember the last time I have been this sick, and my symptoms just won't go away.  I haven't had any kind of bronchitis since I was young, and I have never had tremors like this before in my life.  This illness has been very unusual for me, and I am sure the flu shot is the problem.  I have missed a lot of work because of the problems I have been having since October, and I am so weak I cannot do much of anything right now.  I am still coughing like crazy, having headaches, dizziness, tremors, chest pain, etc.etc.--everything I have had since October.  I have spent a trememdous amount of money on doctors and tests and medications as well, and that aspect has been difficult.  I will never get another flu shot!!!				Y					N	10/08/2007	10/09/2007	1	I have had several rounds of blood work, culture of my nose, CAT scan of sinuses, allergy testing, blew into that machine at the allergist's office, chest x-rays, EKG, oxygen saturation test.	UNK	UNK	Levbid, Singulair, Nasonex, Durahist PE, Zyrtec D, Yaz BCP, Miralax, Zoloft, Flexeril, Relpax PRN, Zomig Nasal Spray PRN, albuterol PRN (rare), Darvocet PRN, OTC Gaviscon PRN, OTC Pepsid AC PRN	None	Year round allergies, TMJ, migraines, endometriosis, IBS, chronic idiopatic constipation, reactive hypoglycemia, chronic sinus problems, low immune system.  Allergic to penicillin, all tape, biaxin, benzoyl peroxide, aspirin sensitive due to previous history of peptic ulcers.	Lethargic, coma like state I believe--happened immediately after the immunization when I was a child.  My mother also told me to		1						1	Allergy test; Asthenia; Blood test; Bronchitis; Bronchospasm; Chest X-ray; Chills; Computerised tomogram; Cough; Culture; Dehydration; Dizziness; Dyspnoea; Electrocardiogram; Erythema; Flushing; Headache; Heart rate increased; Immunoglobulins; Inflammation; Nasal congestion; Oxygen saturation; Pallor; Pyrexia; Rash; Rash macular; Sinusitis; Tremor; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ASLLA043AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0300338	12/19/2007	GA	31.0	31		F	12/19/2007	Adm vaccine on 12/06/2007 and client inform us of pregnancy 12/14/2007									U	12/06/2007				PUB	PUB	NOne	None	None			1						1	Drug exposure during pregnancy	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80682~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|MMR~MERCK & CO. INC.~0806f~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|MNQ~SANOFI PASTEUR~u2172AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~2759AA~1~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0300339	12/19/2007	AL	47.0	47		F	12/17/2007	Swollen left arm with stiffness, pain, and very high temperature in the arm. Treated with Medrol 4 MG Pak 21 Tab and Cephalexin 500mg, one capsule by mouth 3x daily for 7 days. Treatment began on 11-15-06, arm was better by 11-17-07. Completed med regimen as prescribed.				Y					Y	11/13/2007	11/13/2007	0		PUB	UNK						1						1	Musculoskeletal stiffness; Oedema peripheral; Pain; Skin warm	FLU3~SANOFI PASTEUR~U2523AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0601F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0300340	12/19/2007	LA	61.0	61		F	12/19/2007	Swelling at the site of administration that lasted approximately 1 week.  A red streak appeared on my arm, approx. 2 long,the day after I received my shot and remained about 1 week.									Y	10/23/2007	10/23/2007	0	None	UNK	UNK	None	None	None			1						1	Injection site streaking; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0300342	12/19/2007	MD	36.0	36		F	12/19/2007	Patient developed Bell's Palsy 4 days after receiving Sanofi Pasteur Influenza vaccine.  01/16/2008 MR received for DOS 12/18-19/2008 with DX: Left Bell Palsy.  Pt presented to ER with c/o L sided facial weakness since that morning.  Numbness of the tongue x 2 days.  PE (+) L Cranial Nerve VII impairment, otherwise WNL. Tx with Valtrex and prednisone and D/C.				Y	Y	1				12/13/2007	12/17/2007	4	Labs and Diagnostics: Head CT showed a sub-acute infarct in the R caudate. Osteoma in ethmoid air cell region on L.  MRI brain showed focal abnormal T2 prolongation R caudate head  may be from previous injury or ischemia.  No evidence of acute ischemic event. CXR WNL.  Carotid Duplex scan WNL.  CBC with normal WBCs on admit up to 11.0 12/19/07. Sed rate 32. Chem with K+ 2.8 on admit, WNL by d/c. Glucose 108.  Drug screen (-). UA WNL.  Lyme (-).  CRP WNL.	UNK	UNK		Elevated BP	N/A. PMH: HTN.  IBS.  NKDA.			1						1	Facial palsy	FLU3~SANOFI PASTEUR~U2478BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0300343	12/19/2007	NC	1.0	1	.1	F	12/19/2007	L nodule on ant. lat thigh 2cm in lenght and 1 1/2 cm in width. the nodule is firm.									U	12/05/2007	12/05/2007	0	none	UNK	PUB		At the visit mom voice no other concerns or recent illness				1						1	Induration; Skin nodule	FLU3~SANOFI PASTEUR~UT2474AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0437U~4~IM~LL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B54015D~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0300344	12/19/2007	OH	3.0	3		F	12/19/2007	Guardian states that no adverse reactions occurred after vaccine was given.										11/28/2007				PUB	PUB	None	NONE	None	NONE~ ()~NULL~~In Patient|NONE~ ()~NULL~~In Sibling1|NONE~ ()~NULL~~In Sibling2		1						1	Unevaluable event	DTAP~SANOFI PASTEUR~U1985CA~5~IM~LL~DTAP (TRIPEDIA)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500487P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB163AB~2~IM~RL~HEP A (HAVRIX)~1	USA		Influenza
0300345	12/19/2007	PA	6.0	6		M	12/19/2007	Dysdiadochokinesia. C/O headache and pain in idiopathic autoimmune cerebellitis; symptoms of ataxia began on 11/27 getting progressively worse until admitted to facility on 11/30.  Inpatient care including high dose steroids 12/4-12/7 with discharge 12/7 - baseline balance obtained.  Follow up care includes pediatrician, blood work, and PT. 3/3/08-records received-for DOS 11/31-12/7/07-DC DX: likely idiopathic autoimmune cerebritis. Presented with 3 days of clumsiness and stumbling, wobbly gait and intermittent fevers to a max of 101, 3 episodes of emesis after car rides. Decreased p.o. intact. In ED had bilateral dysmetria, positive Romberg sign broad based ataxia. Dysdiadochokinesia. C/O headache and pain in legs.					Y	7			Y	11/19/2007	11/27/2007	8	Diagnosis was idiopathic autoimmune cerebellitis determined by CT, MRI, blood work and physical exam while inpatinet at Hospital 3/3/08-records received-LP showed protein 24, glucose 57, 3 white cells and 28 red cells. Gram stain showed rare white cells no bacteria. Culture negative. CRP 6. CBC with white cells 15.7, hemoglobin 9.3. MCV 62.4, MRI normal. Head CT normal. EBV and CMV and enterovirus DCR negative. Hemoglobin electrophoresis consistent with thalassemia trait.	UNK	UNK		None 3/3/08-records received-Had an upper respiratory infection about 10 days ago which resolved, at that time 10 days ago had swollen anterior cervical lymph node. One pound weight loss since November 19.	Known allergy to cats; no other known medical conditions; normal development 3/3/08-records received-legs.  PMH:VSD which closed. Eczema and Cat allergy.			1						1	Ataxia; Blood test abnormal; Encephalitis	FLUN3~MEDIMMUNE VACCINES, INC.~~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0300362	12/19/2007	FL	61.0	61		F	12/14/2007	Initial report received on 22 October 2007 from a health care professional. A 62-year-old female patient, with a history of cirrhosis of the liver, had received a left deltoid, intramuscular infection of Fluzone SV 2007-2008, lot number U2500AA, on 11 October 2007. One to two days post-vaccination, the patient experienced joint pain and entire body pain. She was examined in an emergency room on 15 October 2007 and was treated with prednisone and morphine and discharged with a prescription for OxyContin. The patient returned to the emergency room on 22 October 2007 and was complaining of generalized pain throughout her body to the point of having difficulty moving. she was again treated with morphine. Diagnostic testing included a full blood profile, chest x-ray and sedimentation rate. Results of the testing were not provided. At the time of this report, the patient had not recovered. Follow-up information was received on 10 December 2007 from a health care professional. Based upon the new information provided in this follow-up, this case has been upgraded to serious. It was reported that the patient experienced joint pain and wheezing the same day she received Fluzone SV 2007-2008. She was treated in the emergency room. A chest x-ray was negative. The patient had no fever at the time of examination, but did complain of diffuse joint pain. Laboratory work done in the emergency room was negative. The patient was started on a Medrol dose pack (methylprednisolone) was given oxycodone. She was seen for a follow-up visit on 19 October 2007 and was feeling back to normal at that time. On 26 October 2007, the patient was seen in the physician's office with complaints of a stiff neck, shoulder, and wrist (right). She was in mild discomfort, but no distress. There was no lymphadenopathy. Range of motion was limited secondary to pain from the base of the skull radiating down the trapezius and bilateral shoulder. There was no bruising or apparent swelling. The patient was diagnosed with polyarthralgia, myalgia and cervical spasm with no meningeal sign. She was prescribed Flexeril and Vicoprofen for pain. The patient was seen by the physician again on 29 October 2007 for follow-up. At that time it was reported that the patient had been diagnosed with polymyalgia rheumatica and per the reporter, the polymyalgic rheumatica was perhaps related to Flu shot but it would seem unlikely based on the temporal relation of onset (i.e. less than 24 hours). The patient's medications at the time of examination included Nexium, Albuterol inhaler, prednisone, and Caltrate. Upon examination, it was noted that the patient had mild swelling and pain with range of motion of large and medium joints. The treatment plan included continuing with current management and follow-up with a rheumatologist. It was reported by the physician that the patient recovered from her symptoms on an unspecified date.				Y					Y	10/11/2007	11/10/2007	30	full blood profile negative, chest X-ray negative, sedimentation rate negative	PVT	PVT	Levoxyl, Osteo Bi-Flex	She had no illness at the time of vaccination.	The patient had a history of cirrhosis of the liver.  Follow-up received on 10 December 2007 notes that the patient's history included a fatty liver, which was confirmed by biopsy in December 2001.  In addition, she had hypothyroidism and tinea corporis.		200703561	1						1	Arthralgia; Blood test normal; Chest X-ray normal; Joint stiffness; Joint swelling; Mobility decreased; Muscle spasms; Musculoskeletal stiffness; Myalgia; Pain; Polymyalgia rheumatica; Red blood cell sedimentation rate normal; Wheezing	FLU3~SANOFI PASTEUR~U2500AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0300363	12/19/2007	PA	50.0			F	12/14/2007	Initial report received on 06 December 2007 from a health care professional. A 50-year-old female patient, with no illness at the time of vaccination, had received an injection of influenza vaccine, manufacturer not reported, lot number not reported, and route and site of administration not reported, on 29 October 2007. Seven hours post-vaccination, the patient experienced heaviness in her arms, weakness in her legs, a backache in the lumbar and dorsal spines, a loss of appetite, and dizziness. She was examined in a physician's office, and physical therapy was ordered. Relevant diagnostic testing was unknown, and past medical history was not provided. At the time of this report, the patient had not recovered.				Y					N	10/29/2007	10/29/2007	0		UNK	UNK					200704190	1						1	Anorexia; Back pain; Dizziness; Muscular weakness; Sensation of heaviness	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0300381	12/19/2007	OK	2.0	2	.1	M	12/17/2007	Morning after being vaccinated, pt began complaining of left leg pain with redness & erythema. That afternoon, eyes began to swell.  Symptoms continued for the next 24 hours. 12/17/07 continues to have mild edema of eyelids.									Y	12/14/2007	12/15/2007	1		PVT	PVT		none	sickle cell trait			1						1	Erythema; Eye swelling; Eyelid oedema; Pain in extremity	FLU3~SANOFI PASTEUR~U2502AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB225BB~2~IM~LL~HEP A (HAVRIX)~1	USA		Influenza
0300399	12/19/2007	MI	62.0	62		F	12/19/2007	7 days after administration developed pruritic, maculo-papular erythematous rash, mostly on the back. Required an Urgent Care visit and treatment with cortisone injection and methyl prednisolone x 7 days and hydroxyzine HCL 25 mg tid.				Y					Y	10/16/2007	10/21/2007	5	None	UNK	PVT	None	Pruritic rash	sulfa and neosporin			1						1	Rash erythematous; Rash maculo-papular; Rash pruritic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79488~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0300429	12/19/2007	VA	0.51	0	.5	M	12/19/2007	12-18-07 intussception - having surgery 12-19-07 1/9/08-records received for DOS 12/18-12/22/07-DC DX: Intussusception. Exploratory laparotomy and reduction of intussusception not reduced by 2 hydrostatic enemas.  Day prior to admission vomting and decrease urine. No bowel movement for 2 days.			Y	Y	Y	4			Y	12/04/2007	12/18/2007	14	Two view abdominal showed dilated loops of small bowel: obstruction 1/9/08-records received-Barium enema incomplete reduction. Upper GI confirms limited ultrasound report, no malrotation, free fluid, favoring intussusception right midabdomen. 1/12/08-received tissue samples from this patient. Results: The sample was positive for adenovirus and negative for rotavirus.	UNK	UNK	None	None	None			1						1	Intussusception; X-ray abnormal	DTAP~SANOFI PASTEUR~C2749AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2456EA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0169~3~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~B540168~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0942U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Life Threatening,Hospitalisation	Influenza
0300431	12/19/2007	CO	55.0	55		F	12/19/2007	Shot administered approx. 2:00 p.m. 12/6/07.  That evening I was extremely tired and did not complete my obligations after shopping for our business.  Next day I was extremely tired and weak, left work early which is very unlike me and went home and slept for 3 hours 3:00 p.m. to 7:00 p.m..  Woke not feeling quite right but continued as normal until approx. 3:00 p.m. at which point I could not continue.  Weak and feverish I layed down on the couch and went to sleep.  I had diareah that evening which continued until 12/18/07.  Fever ended Tuesday 12/11/07 but weakness, sleepy/tired feeling and stomach problems have continued.  I have not taken any medication except for ibuprophen for fever and occassional head ache.									N	12/06/2007	12/06/2007	0	None - Gradually getting better.	UNK	PVT	Synthroid	None	Thyroid			1						1	Asthenia; Diarrhoea; Fatigue; Pyrexia; Somnolence; Stomach discomfort	FLU3~SANOFI PASTEUR~~1~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300433	12/19/2007	CA	12.0	12		F	12/19/2007	VASOVAGAL SYNCOPE EPISODE LASTED FOR AT LEAST 5 SECONDS. PATIENT TRANSPORTED VIA WHEELCHAIR IN THE TREATMENT WITH MOM. VITAL SIGNS TAKEN (BP80/50;PR 82;RR12;T 97.1;O2SAT 94%. APPLIED ICE PACK ON BACK OF NECK AND FOREHEAD. NO DIZZINESS, N/V,SOB/DYSPNEA, CHEST PAIN, DENIES WEAKNESS, NO COLD CLAMMY SKIN, NO LABORED BREATHING. NO HIVES. NO OTHER SXS NOTED/REPORTED. OFFERED SIPS OF WATER WHICH PATIENT TOLERATED. STAYED WITH PATIENT FOR 20 MINUTES RECHECKED VITAL SIGNS STABLE ( BP 90/56;PR86;RR16;O2SAT 100%). SKIN LOOKS NORMAL AND PATIENT STATES FEELS MUCH BETTER. ASKED TO SIT UP PATIENT TOLERATED AND ABLE TO AMBULATE WITH MOM. REVIEWED WITH MOM THE VISs AND TO SEEK ER CARE/CALL CLINIC IMMEDIATELY IF PATIENT HAVING SERIOUS ALLERGIC REACTION.									Y	12/19/2007	12/19/2007	0	NOT APPLICABLE	PVT	UNK		NONE				1						1	Syncope vasovagal	FLU3~SANOFI PASTEUR~U2506AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1258U~UNK~IM~RA~HEP A (VAQTA)~1|HPV4~MERCK & CO. INC.~0755U~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2383BA~UNK~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2690AA~UNK~IM~RA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1054F~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0300436	12/19/2007	CA	48.0			M	12/19/2007	Pt provided information via phone:  Vaccinated on 3 Dec 07.  Fluarix -prefilled injectable vaccine.  Pt indicated that he had chest tightness within 10 minutes of the vaccine/light headed (did not notifiy the vaccinator).  Also had sharp pain at the injection site.  Left clinic and 45 minutes later was light headed and pain radiating down left arm.  Presented to ER and cardiac workup completed.  Screening form completed by patient indicates no allergies but pt verbalized allergy to codeine.				Y					Y	12/03/2007	12/03/2007	0	Pt was vaccinated via employee site eligibility.  Seen by provider for symptoms described above.  Pt indicated that he had EKG, labs and monitoring completed.  Indicated that all results were within normal limits.	MIL	MIL	Information not available	Information not available	Information not available			1						1	Chest discomfort; Dizziness; Drug hypersensitivity; Electrocardiogram normal; Injection site pain; Laboratory test; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~SYR~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0300447	12/19/2007	NE	57.0	57		F	12/12/2007	Flu shot on 10/23/07; 10/25 laryngitis; 11/4 hands tingly & numb; 11/5 balance off, BP 180/120; 11/7 difficulty walking; 11/07 hospitalized with diagnosis of Guillain Barre; 11/12 dismissed from hospital. 12/31/07-records received for DOS 11/7-11/12/07-DC DX: Guillain-Barre syndrome. C/O progressive weakness in lower extremities with paresthesias. Developed some incoordination and balance issues. Neuro exam no focal deficits. Quite ataxic with generalized weakness.					Y	5			Y	10/23/2007	10/25/2007	2	lumbar puncture on 11-7-07 12/31/07-records received-Spinal fluid protein 36. ANA negative. Blood cultures negative. MS teseting negative. Echocardiogram ejection fraction of 60% to 65% with mild concentric left ventricular hypertrophy secondar to hypertension. MRI brain and cervical spine essentially negative except for C5-6 small disk with nerve root compression. Hyponatremia 127. EMG normal. IVIG treatment.  Is able to work 8 hr shifts, but tires easily	PVT	PVT		None	Unknown 12/31/07-records received-Hypertension.			1						1	Balance disorder; Blood pressure; Gait disturbance; Hypoaesthesia; Laryngitis; Lumbar puncture; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA303AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0300450	12/19/2007	CA	0.8	0	.8	U		0.5ml flu vaccine given.  No adverse events.  No adverse reactions.										12/19/2007				PVT	PVT		None	None			1						1	Incorrect dose administered; Medication error	FLU3~SANOFI PASTEUR~UT2474CA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300451	12/19/2007	CA	1.5	1	.5	M	12/19/2007	FluMist given out of age criteria.									Y	12/13/2007				OTH	OTH	None	None				1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500490P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0300452	12/19/2007	CA	0.9	0	.9	F	12/19/2007	FluMist was given out of age criteria.									Y	12/13/2007				OTH	OTH	Motrin	None				1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500490P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0300453	12/19/2007	MD	57.0	57		F	12/19/2007	Bioject user.  Per complainant about immediately after receiving vaccinations she states she felt pain.  A few days later she experienced bruising and swelling at injection site.  Since 12/1/07 she has felt throbbing to L deltoid muscle (site of injection) and aching/soreness.  Also is experiencing radiating pain to her L thumb occasionally.  Denies weakness in the L arm extremity.  No treatment by doctor.  Taking OTC NSAID to relieve discomfort.  Plans to see doctor mid Jan.  Encouraged to seek eval. sooner by this nurse.									N	11/29/2007	12/01/2007	2	None at this time	PUB	PUB	OTC NSAIDS, baby aspirin	None				1						1	Immediate post-injection reaction; Injection site bruising; Injection site pain; Injection site swelling; Pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2486AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300456	12/19/2007	MT	55.0	55		F	12/19/2007	Redness, swelling, and warm at the injection site.									Y	10/24/2007	10/25/2007	1		PUB	PUB	Robaxin	None	No allergies; No defects; No medical cond.			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2463AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0961U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0300458	12/19/2007	PA	7.0	7		F	12/19/2007	Questionable syncopal episode.				Y					Y	11/12/2007	11/13/2007	1	EKG, EEG, CTS - normal	PVT	PVT		None				1						1	Computerised tomogram normal; Electrocardiogram; Electroencephalogram; Syncope	FLU3~SANOFI PASTEUR~42526AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0300459	12/19/2007	CA	49.0	49		M	12/19/2007	Pt developed rash which he showed to pharmacist covering left shoulder 2 weeks after flu shot given.				Y					U	12/05/2007	12/17/2007	12	Pt did not go to any physician	OTH	UNK		None disclosed	None disclosed			1						1	Rash	FLU3~SANOFI PASTEUR~U2499AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0300464	12/19/2007	FL	60.0	60		M	12/19/2007	11-17-07, 7:00 pm became light headed, chills and shortness of breath.  Took some hot tea and spoke with MD on phone.  Then became better in a few hours.									Y	11/16/2007	11/17/2007	1	None	OTH	OTH						1						1	Chills; Dizziness; Dyspnoea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78994~1~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0300467	12/19/2007	NV				M	12/13/2007	Lower lip swelling day 3 post vac, urticaria day 3 post vac. R deltoid, + pain, + erythema x24 hours.				Y					U	12/06/2007	12/09/2007	3	None	MIL	PUB	amlodipine besylate, methylprednisolone, metoprolol tartrate, naproxen, niacin, omeprazole, Rosuvastatin CA, terazosin, aspirin, Calcitriol, calcium/vitamin D, Capsaicin, fish oil, flaxseed, folic acid, multi-vitamin, selenium, vitamin A, v	None	allergy to ace-lisinopril, angioedema			1						1	Erythema; Lip swelling; Pain in extremity; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA320BA~2~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0298065	12/20/2007	FL	64.0	64		M	12/18/2007	Sixty-four-year old male with a past medical history significant for type 2 diabetes mellitus which is poorly controlled, obesity, vascular dementia, and a remote history of extremely heavy alcohol abuse who  presented to Emergency Department (ED) with delirium and hyperammonemia. Of note, he had received flu shot prior to his admission. Over the past few days, his step son noted that the patient has been out of it at times. He also reported that the patient is glucoses had been out of control in the 300-400 range at home. He felt as if this might be a reaction to the flu shot, as the same thing happened last year, but at that time the patient had a kidney infection. The patient reported no pain or headache, but did feel nauseated and was having dry heaves. Apparently, he had had a similar presentation with delirium and hyperammonemia after having received a flue shot in 2006. He denied alcohol intake at any time in the past 20 years. Upon evaluation in the Primary Care Clinic, he was found to have an elevated ammonia level of 157, so decision was made for admission for further evaluation and treatment. Abdominal CT Scan was obtained that revealed pancreatic atrophy ass well as fatty liver. A battery of tests and					Y				Y	10/15/2007	11/05/2007	21	Upon evaluation in the primary care clinic, the was found to have an elevated ammonia level of 157.  Abdominal CT scan was obtained that revealed pancreatic atrophy as well as fatty liver.  A battery of tests and	UNK	UNK	analgesic cream-apply small amount to affected area(s) as needed to painful joints; aspirin 81 mg **EC** tab-take one tablet by mouth daily	Active problems: type II DM, hypertension, obesity, sleep apnea	Past medical history significant for type 2 diabetes mellitus which is poorly controlled, obesity, vascular dementia, and a remote history of extremely heavy alcohol abuse.  Apparently, he had had a similar presentation with delirium and hyperammonemia after having received a flu shot in 2006.			1						2	Confusional state; Delirium; Abnormal behaviour; Alcohol abuse; Ammonia increased; Blood glucose increased; Computerised tomogram abnormal; Delirium; Feeling abnormal; Hepatic steatosis; Hyperammonaemia; Laboratory test; Nausea; Pancreatic atrophy; Retching	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~SC~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0300543	12/20/2007	NY	3.0	3		F	12/20/2007	Received Fluzone Vaccine on 12-18-07. Developed fever 101 12-19-07, with left arm hard, red, warm from shoulder to anticub area. Fever continues today, Ice applied, motrin given. Red area measures 12.5 cms X 17 cms diameter 19.5 cms. Right arm diameter is 16.5cms. To F/up with phone call to Dr.				Y					Y	12/18/2007	12/19/2007	1	none	PVT	PVT	None	None	None			1						1	Erythema; Induration; Pyrexia; Skin warm	FLU3~SANOFI PASTEUR~U2513AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0300544	12/20/2007	CA	24.0	24		M	12/20/2007	CP OF CHEST PAIN X 4 DAYS.  PT WAS TRANSFERED TO MEDICAL CENTER. 2/25/08-records received for DOS 12/19-12/21/07DX: Post small pox vaccine myopericarditis. Chest pain, EKG changes, elevated Troponin. Presented to ED with 4 day history of chest pain. No cough, vomiting or diarrhea.  02/02/2010 Patient recieved smallpox inoculation. Developed myopericarditis. Still recovering. Following up with the vaccine healthcenter.				Y	Y	2			N	12/06/2007	12/16/2007	10	2/25/08-records received-Normal cardiac MRI. Troponin I, CKMB elevated.	MIL	MIL	ZYRTEC	WISDOM TEETH REMOVED, AND ASTHMA				1						1	Chest pain; Nuclear magnetic resonance imaging normal; Blood creatine phosphokinase MB; Blood creatine phosphokinase MB increased; Chest pain; Echocardiogram abnormal; Pericardial effusion; Troponin I increased	ANTH~EMERGENT BIOSOLUTIONS~UNKNOWN~3~UN~UN~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~UNKNOWN~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~PFIZER\WYETH~4020076~UNK~ID~UN~SMALLPOX (DRYVAX)~1|ANTH~EMERGENT BIOSOLUTIONS~~1~IM~LA~ANTHRAX (BIOTHRAX)~2|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|SMALL~UNKNOWN MANUFACTURER~~1~~LA~SMALLPOX (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0300586	12/20/2007	TX	57.0	57		F	12/20/2007	Developed severe back pain, lower extremity weakness, and loss of bowel and bladder control 16 days after receiving flu vaccine.  1/4/08 Reviewed hospital D/C summary which reveals patient experienced  lower back pain &  LE weakness x 2 mo which became acute on 11/3/07 w/sudden onset of weakness in bilat LEs w/progression, multiple falls, urinary incontinence.  Seen in ER but sent home when spine & MRI were WNL.  Continued to deteriorate & admitted 11/6-11/21/2007.  Neurology & neurosurgery consults done.  Transferred to inpatient rehab upon d/c. FINAL DX: myelitis w/lower extremity weakness & bowel/bladder dysfunction, etiology unclear, thought to be most likely postvaccination.				Y	Y	15			U	10/19/2007	11/05/2007	17	LABS: CSF protein 61 (H), glucose 88, wbc 0	UNK	UNK	Unknown	Unknown	Unknown PMH: hypothyroidism			1						1	Back pain; Faecal incontinence; Muscular weakness; Urinary incontinence	FLU3~SANOFI PASTEUR~u2510AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0300605	12/20/2007	FL	1.83	1	.9	M	12/20/2007	An adult dose of Hep A was accidently given as the second dose in the series.  No treatment after CDC was consulted.									U	12/20/2007	12/20/2007	0	N/A	PUB	PUB		None	None			1						1	Wrong drug administered	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B049AA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~PFIZER\WYETH~U2481GA~1~IM~RL~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HEPA~MERCK & CO. INC.~0744F~2~IM~LL~HEP A (VAQTA)~1|PNC~PFIZER\WYETH~B54015E~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0300607	12/20/2007	LA	58.0	58		F	12/20/2007	Left arm where injection was given is a very large purple area, since 12-18-07. I have hoarsenes (12-20-07), wheezing (12-18-07), chest tightness (12-20-07). Running noise(12-19-07). I have ashma.				Y					N	12/17/2007	12/17/2007	0		PVT	UNK	Actos 45mg, diovan 40mg, Qvar 80mg	None	Ashma, diabetics, sinus	None~ ()~NULL~~In Patient|None~ ()~NULL~~In Sibling1		1						1	Asthma; Chest discomfort; Dysphonia; Injection site discolouration; Rhinorrhoea; Wheezing	FLUX~UNKNOWN MANUFACTURER~Unknown~2~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0300608	12/20/2007	MO	3.0	3		M	12/20/2007	History was obtained from the child's father, who did not witness the event.  Zeth received DTaP, Hep A, influenza, and varicella vaccines on 12/12/07 at a routine well child exam.  On 12/13/07, while at school, he reportedly had a seizure-like episode involving unresponsiveness, flushing, and eyes rolling back which lasted approximately 2 minutes.  The child appeared normal immediately after the event.  The child has a strong family history of seizure disorders (father and paternal uncles with poorly controlled seizures).  The child was brought to the ER several hours later where he appeared well.  Laboratory evaluation at that time was normal.				Y					Y	12/12/2007	12/13/2007	1	EEG pending.	PUB	PUB	None	Acute Otitis Media	Speech delay			1						1	Convulsion; Electroencephalogram; Familial risk factor; Flushing; Gaze palsy; Unresponsive to stimuli	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B057AA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~V2479AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB214AA~1~IM~RL~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1462U~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0300610	12/20/2007	NH	52.0	52		F	12/20/2007	Elevated temp (101), naseua, chills, headache for over 24 hours.									Y	11/15/2007	11/15/2007	0		PUB	UNK		none	seasonal allergies, pennicillin allergy			1						1	Body temperature increased; Chills; Headache; Nausea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~I think~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0300611	12/20/2007	FL				U	12/20/2007	The site where the vaccine was taken started swelling									N	12/17/2007	12/17/2007	0		UNK	UNK		After receiving the flu shot, the area where the shot was taken statee swelling and itching. It has been swollen since Monday December 17,2007 , and it is still swollen now.				1						1	Injection site swelling	FLU3~SANOFI PASTEUR~u2457ga~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300612	12/20/2007	LA	1.0	1	.0	F	12/20/2007	ON 11/20/07 MMR GIVEN IN LEFT THIGH AND INFULENZA AND HEP. A GIVEN IN RIGHT THIGH.  MOTHER STATED BABY DEVELOPED FEVER-101 AND A COMPLETE BODY RASH ON 12/02/07.  WENT TO SEE HER PEDIATRIC MD, AND SHE STATED THAT THE BODY RASH WAS POSSIBLY FROM THE MMR.  MOTHER CAME IN TODAY FOR THE 2ND FLU INJECTION AND INFORMED ME OF THE ABOVE.				Y					Y	11/20/2007	12/02/2007	12	NONE	UNK	UNK		NONE	UNKNOW			1						1	Pyrexia; Rash generalised	FLU3~SANOFI PASTEUR~UT2460CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB217AA~1~IM~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0748U~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0300614	12/20/2007	CA	51.0	51		F	12/20/2007	12/19/07 Face was red.  Felt fatigued. That night scapl started tingling. Today 12/20/07 red bumpy rash starting midline on forehead at hair line, extending to above ear on right side. Rash and swelling also under right eye.  Feeling of pin and needles in area of rash..									U	12/17/2007	12/19/2007	2	Was with her husband at his dermatology appointment.  The dermatologist perscribed acyclovir for her.	PVT	PVT	Augmentin  for a cat bite	History of a cat bite.	Denies any			1						1	Erythema; Eye swelling; Fatigue; Flushing; Paraesthesia; Rash	FLU3~SANOFI PASTEUR~U2441AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300629	12/20/2007	NY	38.0	38		F	12/20/2007	This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in a 38-year-old pregnant female subject who was vaccinated with influenza vaccine trivalent (Flulaval, GlaxoSmithKline) for prophylaxis.  On 20 November 2007, the subject received unspecified dose of Flulaval (.5 ml, unknown, left arm).  On 22 November 2007, 2 days after vaccination with Flulaval, the subject experienced extensive swelling of vaccinated limb, tenderness, erythema, rash and warm to touch.  The swelling occurred in the left elbow, slightly above the elbow area and into the lower forearm.  The subject went to the emergency department and was admitted to the hospital.  The subject was diagnosed with cellulites.  At the time, the events occurred the subject was 6 weeks pregnant and had not seen a gynecologist for a delivery date.  The subject was treated with amoxicillin trihydrate + potassium clavulanate (Augmentin (oral)) 875 mg twice daily.  At the time of reporting the outcome of the events were unspecified.				Y	Y	0			U	11/20/2007	11/22/2007	2	Unknown	PVT	OTH		Unknown	It was unknown if the subject had previously received influenza vaccinations or experienced adverse events.  It was unknown if the subject had adverse events following receipt of prior immunizations.  The subject was approximately six weeks pregnant and had not been seen at a gynecologist office at the time of reporting.  Due date unknown.  The subject was scheduled to return to her primary care physician's office for follow-up on 18 December 2007.		A0700166A	1						1	Cellulitis; Drug exposure during pregnancy; Erythema; Feeling hot; Oedema peripheral; Rash; Skin warm; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA039AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation	Influenza
0300635	12/20/2007	AZ	69.0	69		F	12/20/2007	None stated				Y						12/18/2007	12/18/2007	0		PVT	PVT	Estradiol Patch; Armour Thyroid	None	None			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2525AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0300637	12/20/2007	GA	72.0	72		F	12/07/2007	The same day of shot I started feel achey. I started running fever from 99-100 every day since. Her nurse said I had a virus and I am still sick. My daughter and grandson has gotten what I have I am still sick									N	10/29/2007	10/29/2007	0		PVT	PVT	No	No				1						1	Malaise; Pain; Pyrexia; Viral infection	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0300638	12/20/2007	CA	11.0	11		F	12/14/2007	Redness/swelling of left upper arm at injection site.									Y	12/11/2007	12/14/2007	3	None	PUB	UNK	None	None	None			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2502AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB213AA~2~IM~RA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~0927U~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2383BA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2731AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0300639	12/20/2007	NY	0.1			M	12/03/2007	Infant was given adult dose 0.5 ml influenza vaccine in (L) thigh. No adverse effects noted.									Y				None	MIL	PVT	None	None	None			1						1	Incorrect dose administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~IM~LL~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0300640	12/20/2007	IA	0.2	0	.2	M	12/12/2007	Swelling in upper left leg.									Y	12/08/2007	12/08/2007	0	None	PVT	PVT	None	None				1						1	Injection site swelling	FLU3~SANOFI PASTEUR~U2480DA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300641	12/20/2007	NY	41.0	41		F	12/11/2007	Redness to site, swelling inferior and superior to site, warmth.									Y	12/10/2007	12/10/2007	0	None	PUB	UNK	Cymbalta; Prilosec; Loratadine; Campral Chantix	Alcohol dependency	COPD, Depression			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Skin warm; Swelling	FLU3~SANOFI PASTEUR~U2444AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~9722106~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0300642	12/20/2007	IL	69.0	69		M	12/06/2007	12/5/07 PM: Pt rcvd vaccine and said during night he was shaking and chills and took Tylenol, felt better next AM, but felt weak.									Y	12/05/2007	12/06/2007	1		OTH	OTH						1						1	Asthenia; Chills; Tremor	FLU3~SANOFI PASTEUR~U2450AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300643	12/20/2007	NM	3.0	3		M	12/12/2007	Large, non-tender, itchy area to skin at left deltoid injections site.									Y	12/10/2007	12/12/2007	2	None	PUB	PVT	None	None	None			1						1	Injection site pruritus	FLU3~SANOFI PASTEUR~U2454AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300644	12/20/2007	TX	6.0	6		F	12/12/2007	Redness with some swelling noted at injection site of the Varivax. 5.1 cm x 6.2 cm redness, 4.2 cm x 4.2 cm knot, warm to touch. Doesn't itch or bother her. Mom to call if knot and redness persist. Right upper thigh.									Y	12/04/2007	12/05/2007	1	N/A	PVT	PUB	None	None	None			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Skin warm	FLU3~SANOFI PASTEUR~U2476HA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1002U~2~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0300645	12/20/2007	NE	60.0	60		F	12/11/2007	Soreness at site RSQ, no symptoms noted, then noted in mirror hives at injection site, warm to touch and itchy, and redness which went away week of 11/16/07. Approx 11/14 symptoms of Rt shoulder pain with ROM and touch began. Has treated with moist heat, anti-inflammatories, Tylenol, changed bras and different bed pillows - no relief. Has some noted swelling of Rt axilla. No redness, tenderness or swelling at injection site.				Y					U	11/06/2007	11/06/2007	0	N/A	PUB	UNK		N/A	Penicillin			1						1	Injection site erythema; Injection site pruritus; Injection site urticaria; Injection site warmth; Musculoskeletal pain; Oedema peripheral	FLU3~SANOFI PASTEUR~U2502AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0300647	12/20/2007	MI	51.0	51		F	12/14/2007	Fever, body aches, headache, cough									Y	12/10/2007	12/13/2007	3		PVT	PVT						1						1	Cough; Headache; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~81108~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1132U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0300649	12/20/2007	CA	5.0	5		F		The evening of day of administration the patient c/o pain but nothing seen by mom.  In the AM, the arm looked red and swollen.  The redness and swelling progressed down to forearm.				Y					Y	12/12/2007	12/12/2007	0		PVT	UNK	None	None	None			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2475HA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0300650	12/20/2007	GA	0.8	0	.8	M	11/13/2007	Received flu vaccine in office and developed 104 fever in late evening. Went to Emergency Room and after exam was told fever due to flu vaccine.				Y					Y	10/30/2007	10/30/2007	0	Blood work - all normal	PVT	PUB	None	None	Hosp for Rotavirus dehydration at 7 wks old.			1						1	Blood test normal; Pyrexia	FLU3~SANOFI PASTEUR~UT2473GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0300653	12/20/2007	WI	51.0	51		F	12/14/2007	Back ache, blister on Lt side of upper outside of lip, sneezing, dried blood in nose. 3 pox like blisters on Rt side of face.									Y	11/16/2007	11/17/2007	1	N/A	PUB	PUB	Tylenol 3	N/A	No			1						1	Back pain; Blister; Lip blister; Sneezing	FLU3~SANOFI PASTEUR~U2441AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300659	12/20/2007	NC	1.0	1	.0	M	12/19/2007	Redness, rash looking bumps on upper right thigh, warm to touch.				Y					Y	12/10/2007	12/18/2007	8		PVT	PUB		none	none			1						1	Injection site erythema; Injection site rash; Injection site warmth	FLU3~SANOFI PASTEUR~2508AA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0260U~3~~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0185U~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B70143A~3~~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1330U~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0299351	12/21/2007	MI	55.0	55		M	12/21/2007	CLIENT HAD FLU VACCINE 11/13/2007. CLIENT WAS ADMITTED TO HOSPITAL ON 11/25/2007, HAD SPINAL TAP (ALBUMIN 129), ON RESPIRATOR,RECEIVED IMMUNOGLOBULIN THERAPY AT MEDICAL CENTER,THEN ON 12/03/07, WAS TRANSFERRED TO HOSPITAL FOR SUPPORTIVE CARE. CLIENT HAS A TRACH, COMPLETE PARALYSIS, AND ABLE TO OPEN & MOVE EYES ON 12/10/07,DIALYSIS STARTED ON 12/15/07. PHYSICIAN WILL DECIDE ON USE OF PLASMAPHERESIS ON 12/28/07. CLIENT HAS NOT STARTED ON PHYSICAL THERAPY YET DUE TO COLLAPSE LUNG AND POOR O2 LEVELS.  SPOUSE RELATES THE NEUROLOGIST HAS SENT A REPORT TO CDC & MDA.  CLIENT RECEIVED THE INFLUENZA VACCINE AT DR. OFFICE.			Y	Y	Y		Y			11/13/2007	11/23/2007	10	ALBUMIN 129 IN SPINAL FLUID	UNK	UNK		CLIENT WITH HX OF ALLERGIES AND SINUS DISCHARGE, ALSO HAS SLEEP APNEA AND USES C-PAP.	HX OF SLEEP APNEA AND USES C-PAP			1						2	Asthenia; Guillain-Barre syndrome; Lumbar puncture; Albumin CSF increased; Collapse of lung; Dialysis; Life support; Lumbar puncture; Oxygen saturation abnormal; Paralysis; Tracheostomy	FLU3~SANOFI PASTEUR~-U2467AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2467AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0300706	12/21/2007	MO	45.0	45		F	12/12/2007	12-04-07 PATIENT HAD TB TEST DONE AND FLU SHOT.  12-07-07 PATIENT HAD TB TEST READ, SHE SHOWED US HER LEFT FA WHERE SHE SAID SHE RECEIVED HER FLU SHOT, AREA ON LEFT FA RED, RAISED, APPROXIMATE SIZE OF PENNY.  NURSH ADM. FLUE SHOT INTRADERMALY.  ADMINISTRATOR AND DR NOTIFIED, NO TREATMENT NECESSARY.  ON-GOING FOLLOW UP WITH PATIENT REGARDING LOCAL REACTION. (PPD, SANOFI PASTEUR, C2805AA, INTERDERMALLY)									Y	12/04/2007	12/04/2007	0	NONE	UNK	UNK		NONE	SEEKING TREATMENT FOR ARTHRITIS		MO200745	1						1	Injection site erythema; Injection site swelling; Wrong technique in drug usage process	FLU3~SANOFI PASTEUR~U2437AA~UNK~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300707	12/21/2007	MO	1.92	1	.9	F	12/13/2007	AT HOME STARTED HAVING HIGH FEVER - 104F GAVE HER TYLENOL THEN HAD SEIZURE AND VOMITING. WENT TO ER SEING DOCTOR TODAY FOR CHECKUP 12-13-07				Y					Y	11/30/2007	11/30/2007	0	NONE	UNK	UNK	SINGULAIR	NONE	SPINAL DEFORMITIES AND MISSING RIBS, PRONT TO ASPIRATION AND ALLERGIES		MO200746	1						1	Convulsion; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~UT2477DA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0300744	12/21/2007	CO	0.92	0	.9	M	12/21/2007	Hives began appearing on torso within 2 hours of shot.  Within 9 hours hives spread to limbs.  By 18 hours post-shot entire body was covered (thousands of hives.)  Patient started on Benedryl after Dr. visit 11/05/07.  Hives did not fully disappear for 2 weeks.				Y					Y	11/03/2007	11/03/2007	0	Patient given a food mix RAST test (blood test) on 11/16/2007.  Results came back negative for any food allergies, including eggs.	PUB	UNK						1						1	Radioallergosorbent test negative; Urticaria	FLU3~SANOFI PASTEUR~U2454AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0300745	12/21/2007	UT	55.0	55		M	12/21/2007	Patient developed 1.5 cm area of redness and ulceration at left deltoid injection site. 0 pain. Has not received medical tx r/t wound.									U	12/18/2007	12/20/2007	2	N/A	PUB	PVT		N/A	cats/dogs			1						1	Injection site erythema; Injection site ulcer	FLU3~SANOFI PASTEUR~U2509AA 0.5mL~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U 0.5mL~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0300753	12/21/2007	LA	4.0	4		M	12/20/2007	Information has been received from the mother of a 4 year old male with chronic sinus infections who on 05-DEC-2007 was vaccinated with Pneumovax 23. Concomitant therapy included cefixime (SUPRAX) and influenza virus vaccine (unspecified) in the other leg. On 05-DEC-2007 the patient developed a fever of 104 degrees and could not walk. On 06-DEC-2007, he was taken to the emergency room and was admitted to the hospital. The mother reported that an infection had begun in her son's leg at the injection site. She reported that his leg had to be drained via a leg tube in his leg. She stated that he had to have two emergency surgeries and six stitches in his leg. She reported that he was hospitalized for four days and then discharged home to continue with unspecified antibiotics for 6 weeks. She stated that he is recovering at home. Additional information has been requested. 1/4/08 Reviewed hospital medical records which reveal patient experienced fever, swelling, pain & induration of left thigh. Admitted 12/6-12/10/2007.  Taken to OR 12/6 & again on 12/9 for I&D of left thigh.  Allergy/Immunology, ortho & ID consults done.  ID consult mentions that patient also received flu vax. Tx w/multiple IV antibiotics.  Progressed well & d/c to home on continued oral antibiotics.  FINAL DX: myofasciitis, left thigh; chronic otitis media bilateral ears; and yeast infection left axilla. 1/8/08 Received vax record which confirms patient received flu & pneumo.  VAERS database updated w/same.				Y	Y	4	Y		Y	12/05/2007	12/05/2007	0	ultrasound, temperature measurement 12/05/07 104 Had been given pneumovax due to pneumo antibodies showing only 2/14 serotypes protective.   LABS: WBC 17.4 (H), ESR 269H), CRP 5.7 (H).  IgE 211 (H).  Blood & wound c/s neg.  US of left thigh/hip revealed extreme muscle edema	OTH	OTH	Suprax	sinus infection	PMH: c-section, no complications.  Seasonal allergies.  Asthma.  Eczema.  Milk intolerance.  Recurrent ear infections, multiple PE tubes inserted.  Bronchiolitis.  Adenoiditis.  T&A at 13 mos. Continued to have multiple sinus infections.  Had strep pneumo 11/06.  Immunology w/u done.  Family hx of allergic rhinitis, asthma, recurrent ear infections & PE tubes.  Had been given pneumovax due to pneumo antibodies showing only 2/14 serotypes protective.		WAES0712USA06718	1						1	Abasia; Body temperature increased; Injection site infection; Pyrexia; Surgery; Abasia; Incisional drainage; Injection site erythema; Injection site pain; Joint swelling; Pyrexia; Surgery; Ultrasound scan	FLU3~SANOFI PASTEUR~42436AA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0038U~1~UN~LL~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~42436AA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0038U~1~UN~LL~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0300759	12/21/2007	OR	16.0	16		M	12/10/2007	Fever, Rigors, Leukocytosis, hypotension 12 hr after 23 valent Pneumococcal vaccine Presented like a Septor Pusm. Culture Negative; DATE OF ADMISSION: 11/17/2007; HISTORY OF PRESENT ILLNESS: Patient is s 16-year-old with a chronic medical condition of autoimmune lymphoproliferative syndrome. He has carried this diagnosis since five years of age. It is manifested by recurrent bouts of thrombocytpoenia and in the past, anemia and leukopenia. Patient has had multiple hospitalizations for complications of this, including blood product transfusions in the past. Patient has actually been doing fairly well this fall. He had an episode of thrombocytopenia with platelet counts under 20,000 that necessitated a course of prednisone in 09/07. He was able to be successfully weaned off of this and with adjustment of his other medications he had been doing well for well over a month now. He was in the office yesterday for his influenza vaccine and pneumococcal vaccine 23-valent. He had Prevnar this summer with a recommended booster dose in three months. Patient developed shaking chills, rigors, and fever to 102 deg last night. He was given 1,000 mg of Tylenol at home and a repeat dose in early morning, approximately six hours later. He continues to have shaking chills, headache, nausea, and body aches; Reason for Admission: A 16-year-old boy with ALPS presented with fevers and hypotension. Hospital Course: The patient was transferred from Hospital for rigors, chills, headache, and hypotension that started after the day after receiving a flu and pneumonia Vaccine. He had also had mild URI symptoms preceding the vaccination but those had largely resolved 2 days prior to the vaccination. The patient has a history of ALPS that was diagnosed at 5 years old and has frequently needed hospitalizations with steroid treatment for approximately 1 month at a time. He is generally admitted for thrombocytopenia and receives IVIG with steroid bursts. His most recent hospitalization was early September 2007 for that reason. He had a splenectomy at 7 years old and is on Cellcept and penicillin. During his current hospitalization, the patient was transferred from hospital to Health Science University PICU where he was continued on the vancomycin and ceftriaxone that had been started at hospital, given IV hydrocortisone at stress dose levels, and a rapid flu test was drawn. The patient was hypotensive at 90/30 and tachycardic in the 120s. He received fluid resuscitation, and dopamine was initiated with significant and rapid improvements. He was weaned from his dopamine after several fluid boluses and maintained good urine output. He was transferred to the standard pediatric floor 11/19/2007 approximately 18 hours after admission when his blood pressures had stabilized, and he had become afebrile. The rapid flu test flu test was positive, so the patient was initiated on Tamiflu treatment; however, once he was delivered to the pediatric floor, he was clinically stable with labs correcting, and Tamiflu and antibiotics were all discontinued when blood culture was negative x48 hours. The patient's white count had corrected to 24 from a high 55.6. His platelets were stable at 360 at the time of discharge. His ESR was elevated at 24, and his CRP was also mildly elevated. CSF had no growth to date x72 hours at the time of discharge. Hydrocortisone was also discontinued at the time of transfer to the standard pediatric floor since the patient had not been on long-term steroid dosing prior to admission. He maintained stable blood pressures and was afebrile. 12/26/07-records received with report for DOS 11/17-11/20/07 DC DX: Clinical sepsis. Hypotension. Fever. ALPS. C/O shaking chills, rigors and fever to 102 last night. Headache, nausea and body aches.					Y	3			Y	11/16/2007	11/17/2007	1	CBC (white count corrected to 24 from a high of 55.6, platelets stable at 360 at the time of discharge); CMP; CRP mildly elevated; ESR elevated at 24; CSF had no growth to date x72 hours at the time of discharge; rapid flu positive; blood, urine and viral cultures 12/26/07-records received- Rapid flu test positive. ESR elevated 55.6, CRP mildly elevated. CSF no growth.	PVT	PVT	Cellcept 1 gram Bid; PCN 500mg Bid	None 12/26/07-records received-Mild URI symptoms preceding vaccination but those had largely resolved 2 days prior to vaccination.	ALPS; thrombocytopenia, anemia, leukopenia; allergic to sulfamethoxazole, trimethoprim 12/26/07-records received-PMH:autoimmune lymphoproliferative syndrome.		OR200753	1						1	Blood culture; C-reactive protein increased; CSF culture negative; Chills; Culture urine; Full blood count; Headache; Hypotension; Influenza serology positive; Leukocytosis; Metabolic function test; Nausea; Platelet count normal; Pyrexia; Red blood cell sedimentation rate increased; Tachycardia; Tremor; Upper respiratory tract infection; Virus culture; White blood cell count increased	FLU3~SANOFI PASTEUR~U2512AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0002F~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0300762	12/21/2007	TX	58.0	58		F		Tues Nov 12-Following injection, patient talked with nurse and started to work. Patient began to fell bad-similiar to patient's twice a year sinus infections. As soon as patient got to work around 11 am, all patient could do was hand my sick leave request that just read I feel terrible. Patient went home and stayed there. Patient was weak sick Tues, Wed, Thurs, Fri. Patient saw their doctor on Thurs Nov 15, patient physician diagnosed bronchitis. Antibiotic helped slowly. This was as bad as the flu.				Y					Y	11/12/2007	11/12/2007	0		OTH	PVT	Effexor XP 150mg, Lithium 300mg (2), Ferron Iron tabs	slight runny nose	Bipolar-functional for 25yrs, teaching career, always under Dr's care.	felt ill~Influenza (Seasonal) (no brand name)~~0.00~Patient		1						1	Bronchitis; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0300764	12/21/2007	SC	48.0	48		F	12/17/2007	Severe pain in right upper extremity at vaccine site. Has persisted for greater than 6 weeks.									N	10/15/2007	10/15/2007	0		OTH	PVT		none	none			1						1	Injection site pain	FLU3~SANOFI PASTEUR~11S508M~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300771	12/21/2007	NV	53.0	53		F	12/21/2007	Right arm and hand are feeling weak, hurts to lift,complains of pain at the site of injection to just below the elbow on the right arm. Pain when lifting. Has seen PMD who reports grips are equal.									N	11/08/2007	11/08/2007	0		UNK	UNK		none	none			1						1	Injected limb mobility decreased; Injection site pain; Muscular weakness	FLU3~SANOFI PASTEUR~u2508aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300802	12/21/2007	MO	50.0	50		F	12/24/2007	Within an hour or two of shot I experienced redness, swelling, burning in face on side of shot, hives, hands swelled, arm swelled, itching.  Later I developed some congestion & body aches.  On 12/03/07 still have body aches & slight itchiness with just a little congestion.  No visible hives or swelling.  Also on 12/03/07, I felt funny.  Somewhat scatterbrained like my thoughts were not as cohesive as normal.  I felt something was not right.									Y	11/29/2007	11/29/2007	0	None	PUB	OTH		None documented	None documented			1						1	Burning sensation; Disorientation; Erythema; Feeling abnormal; Oedema peripheral; Pain; Pruritus; Respiratory tract congestion; Swelling; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79716~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0300806	12/21/2007	IN	1.3	1	.3	F	12/21/2007	Hives on legs and feet.  Irritable.  Decrease in appetite and decrease in sleep.									N	12/05/2007	12/06/2007	1	None	PUB	PUB		None				1						1	Decreased appetite; Insomnia; Irritability; Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B067AA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2474FA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08702B~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1358U~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0300808	12/21/2007	TX	65.0	65		F	10/12/2007	10/3 patient experienced discomfort and swelling of L arm between shoulder and elbow, which worsened by Friday 10/5 when she consulted us by phone.  Because of extent of swelling and discomfort we referred pt. to physician, who prescribed Keflex x7 days for infection.									Y	10/02/2007	10/03/2007	1		UNK	OTH						1						1	Infection; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2452AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0554U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0300809	12/21/2007	MA	49.0	49		F	12/10/2007	Complained of bad headache and swollen red eyes which started 2 hours after injection, seen by primary care physician who diagnosed migraine and prescribed medicine (unknown what), headache continued and she went to emergency room, meningitis was suspected.  Labs and tests done, refused spinal tap, spent a day in emergency room Percecet, compazine and IV fluids.  Recovered 48 hours after flu shot.				Y					Y	12/03/2007	12/03/2007	0	Reaction to the flu shot.	PUB	PUB	None	None	None		MA0715	1						1	Eye swelling; Headache; Laboratory test; Migraine; Ocular hyperaemia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA050AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0300811	12/21/2007	MN	50.0	50		F	10/29/2007	Patient came to the office late this afternoon because of the onset of rigors and feeling ill.  Due to her situation, we saw her right away.  By history, she was feeling perhaps a little under the weather yesterday in a nonspecific way.  She got up feeling well this morning, and remembers having her influenza vaccine at about 10:30, this morning.  She felt fine afterwards and had a massage done for neck discomfort between 2:00 and 3:00.  It was about 3:00 in the afternoon that she started having rigors.  She comes in to the office shaking and covering herself up with a jacket.  She was not aware that she is febrile, but is.  On reviewing her medications, she takes nothing by prescription, but is on a number of herbs and vitamins.  I questioned her in detail regarding this illness as there is no obvious explanation for the rigors.  She denies headache or dizziness, sinus symptoms, or sore throat.  There has been no nausea or vomiting, abdominal pain and no diarrhea or change in bowel habits.  She has absolutely no cough, shortness of breath, chest pain, or myalgias at this point.  She denies any urinary symptoms.  There has been no rash.  She has had a flu shot every year without problem.  There has been no itch or urticaria with this flu shot.  She has had a history of smoking, goiter, and from a surgical standpoint is that only a fine needle aspiration of the thyroid and carpal tunnel release.  Blood pressure 110/68.  Heart rate 80 and regular.  Temperature 102.2, which I checked several times.  O2 saturation is 99%.  On exam, she is shivering and has rigors.  She is alert and otherwise looks well.  She feels warm.  On ENT examination, there is no adenopathy.  Her ears are normal.  Pharynx is clear.  No erythema.  Lungs, clear.  Good breath sounds anteriorly and posteriorly.  Heart exam normal.  No murmur.  Abdomen - soft and nontender.  There is no hepatosplenomegaly.  No tenderness anywhere.  No hernia.  Extremities - normal.  No edema.  Skin - no rash.  From the lab standpoint, we checked a urinalysis, which was clear and a white count, which was 9000.  I stayed with her for about 45 minutes through this evaluation.  By then end of the period of time, the rigors had stopped and her fever had peaked up to 102.2.  Again, on re-reviewing the history, there is no symptom that directs us in any area.  Theoretically, this could be a flu shot reaction or reaction to massage, less likely.  More than likely, this is a viral syndrome.  I impressed on her the need to let us know if things change or worsen.  I will call her tonight and we will have someone call her tomorrow morning.  She knows to call us when or if needed.  Presently, there is nothing to use an antibiotic for and I think we need to simply follow.  She is well aware of this and agrees.  Case is closed on 10/23/07 at 9:10 pm.				Y					Y	10/23/2007	10/23/2007	0	Urinalysis- clear - 10/23/2007 White blood count - 9000 - 10/23/2007	OTH	PVT		None	Bee sting (hymenoptera allergenic extract).  History of smoking, goiter, thyroid and carpal tunnel release.			1						1	Chills; Malaise; No reaction on previous exposure to drug; Pyrexia; Tremor; Urine analysis normal; Vaccination complication; Viral infection; White blood cell count normal	FLU3~SANOFI PASTEUR~U2529AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0300813	12/21/2007	AZ	4.0	4		F	12/13/2007	Redness, swelling on left arm.  Prelone given, otc Benadryl, rechecked on 12/13/07 at 2nd appt.  Redness gone, swelling down.  Still hard spots on left arm.				Y					Y	12/10/2007	12/12/2007	2		OTH	OTH		None	None			1						1	Injection site erythema; Injection site induration; Injection site swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B067AA~5~UN~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2456AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB436AA~3~UN~LL~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAB225BB~2~UN~RL~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~A0110~4~SC~UN~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0866U~2~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0300816	12/21/2007	TN	1.0	1	.0	M	12/21/2007	Rash, fever				Y					Y	11/27/2007	12/06/2007	9	Normal CBC 12/2007	PVT	PVT	None	None	History of intrauterine growth  retardation			1						1	Full blood count normal; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U2449AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1259U~1~~~HEP A (VAQTA)~1|MMR~MERCK & CO. INC.~0865U~1~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B54007D~4~~~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1004U~1~~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0301343	12/21/2007	MD	47.0			F	12/14/2007	This case was reported by a healthcare professional and described the occurrence of lump (NOS) in a 47-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  Concurrent medical conditions included hypertension, reflux and coronary artery disease.  In 2005 the subject received unspecified dose of Fluarix (unknown).  At an unspecified time after vaccination with Fluarix, the subject experienced lump (NOS), erythema, swelling and pain.  At the time of reporting the outcome of the events was unspecified.  Follow-up received on 10 October 2007 indicated that the subject had experienced the same reaction with the influenza vaccine (unknown manufacturer) that she received in 2003 and 2004.  She had no problems with the influenza nasal spray.  She stated that following vaccination with Fluarix, she immediately experienced lump (NOS), erythema, swelling and pain.  The events resolved.  The reporter considered that the events were probably related to the use of Fluarix.									U				UNK	MIL	PUB		Coronary artery disease, gastroesophageal reflux disease, hypertension	Subject had same reaction in 2003 and 2004 with flu vaccine.  Took nasal influenza spray in 2006 and was fine.  No known allergies.		A0684814A	1						1	Erythema; Immediate post-injection reaction; Mass; Pain; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301344	12/21/2007	VA				F	12/14/2007	This case was reported by a pharmacy clinical coordinator via a sales representative, and described the occurrence of red face in a female subject of unspecified age who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  On 1 October 2007 at 13:00 the subject received the first dose of Fluarix (.5ml, unknown) at a pharmacy influenza vaccination clinic.  On 1 October 2007, within 3 hours of vaccination with Fluarix, the subject experienced redness of the face and neck and neck stiffness.  At the time of reporting the events were unresolved.				Y					N	10/01/2007	10/01/2007	0	Unknown	OTH	OTH		Unknown	The subject's medical history, concurrent medical conditions, and/or concurrent medications were not specified.  It was unspecified whether the subject had experienced adverse events following previous vaccinations.		A0685996A	1						1	Erythema; Musculoskeletal stiffness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0301345	12/21/2007					U	12/14/2007	This case was reported by a pharmacy student and described the occurrence of injection site infection in a subject of unspecified age and gender who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  On an unspecified date the subject received unspecified dose of Fluarix (.5ml, unknown).  At an unspecified time after vaccination with Fluarix, the subject experienced injection site infection.  At the time of reporting the outcome of the event was unspecified.									U				Unknown	OTH	OTH					A0687612A	1						1	Injection site infection	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301346	12/21/2007					U	12/14/2007	This case was reported by a healthcare professional and described the occurrence of staphylococcal infection in a subject of unspecified age and gender who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  On an unspecified date the subject received unspecified dose of Fluarix in the left deltoid.  An unspecified amount of time after vaccination with Fluarix, the subject experienced staphylococcal infection at the injection site.  At the time of reporting the outcome of the events was unspecified.  Reporter questioned if the lot of vaccine used could have been contaminated.									U				Unknown	OTH	OTH		Unknown			A0687746A	1						1	Injection site infection; Staphylococcal infection	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA300AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301347	12/21/2007	CA				U	12/14/2007	This case was reported by a physician and described the occurrence of local reaction in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Flu vaccine, GlaxoSmithKline) for prophylaxis.  On an unspecified date the subject received unspecified dose of Flu vaccine (unknown).  At an unspecified time after vaccination with Flu vaccine, the subject experienced local reaction.  At the time of reporting the outcome of the event was unspecified.									U				Unknown	OTH	OTH		Unknown			A0688289A	1						1	Local reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301348	12/21/2007	CA				U	12/14/2007	This case was reported by a physician and described the occurrence of a systemic reaction in a subject of unspecified age and gender who was vaccinated with Flu vaccine, GlaxoSmithKline for prophylaxis.  On an unspecified date the subject received unspecified dose of Flu vaccine (unknown).  At an unspecified time after vaccination with Flu vaccine, the subject experienced a systemic reaction.  At the time of reporting the outcome of the event was unspecified.									U				UNK	OTH	OTH		Unknown			A0688292A	1						1	Nonspecific reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301349	12/21/2007	OR				F	12/14/2007	This case was reported by a pharmacist and described the occurrence of unable to move arm in an adult female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  The subject's medical history included oncology patient.  On 12 October 2007 the subject received 1st dose of Fluarix (.5 ml, intraarticular, left arm).  On 12 October 2007, less than one day after vaccination with Fluarix, the subject experienced severe immobilization in arm and extreme pain of the left arm.  The reporter indicated that the reaction was systemic.  The subject also experienced wrong route of administration as the pharmacist reported that the physician indicated to him that he believed that the subject was vaccinated into the intraarticular space of the shoulder.  The subject required medical attention that was not specified at the physician's office.  At the time of reporting the events were unresolved.  The pharmacist considered the events were probably related to vaccination with Fluarix.				Y					N	10/12/2007	10/12/2007	0	UNK	PUB	OTH		Unknown	Cancer; the reporter only specified that the subject was an oncology patient.  The subject had previously received influenza injections.  The only reactions noted were localized pain.  It was unknown if the subject had any adverse events following previous vaccinations.		A0689595A	1						1	Incorrect route of drug administration; Injected limb mobility decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0301350	12/21/2007	NC	75.0	75		M	12/14/2007	This case was reported by a consumer and described the occurrence of influenza in a 75-year-old male subject who was vaccinated with influenza virus vaccine (Influenza vaccine, manufacturer unspecified) for prophylaxis.  A physician or other health care professional has not verified this report.  The subject's medical history included asthma, four heart attacks, high blood pressure and type II diabetes.  Concurrent medications included Advair, Metformin, Singulair, Losartan, Simvastatin, Felodipine, Metoprolol and Salbutamol sulphate (Albuterol).  On 10 October 2007 the subject received unspecified dose of Influenza vaccine (1 injection, unknown, right arm).  On 17 October 2007, 7 days after vaccination with Influenza vaccine, the subject experienced influenza and lack of efficacy.  The subject noted that he also experienced nasal symptoms.  The subject noted that no medical attention was required.  The subject reported that he was feeling better but still had nasal symptoms.  The subject consulted a healthcare professional regarding his event.  At the time of reporting the events were unresolved.									N	10/10/2007	10/17/2007	7	Unknown	PUB	PUB	Fluticasone + salmeterol Metformin hydrochloride Montelukast sodium Losartan potassium Simvastatin Felodipine Metoprolol	Unknown	Asthma, heart attack, high blood pressure, type II diabetes.  Subject noted that he had experienced four heart attacks.  Subject reported that he has received an influenza injection every year (unknown brand).  No adverse events following previous influenza vaccinations.		A0689829A	1						1	Influenza; Nasal disorder; Therapeutic response prolonged	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301351	12/21/2007		81.0			F	12/14/2007	This case was reported by a healthcare professional and described the occurrence of bump at injection site in an 81-year-old female subject who was vaccinated with influenza virus vaccine (Influenza vaccine, manufacturer unspecified) for prophylaxis.  Previous relevant medical history included the subject always developing a bump at the injection site following influenza vaccinations.  On an unspecified date the subject received unspecified dose of Influenza vaccine (unknown).  At an unspecified time after vaccination with Influenza vaccine, the subject experienced bump at injection site.  At the time of reporting the outcome of the event was unspecified.  In October 2007 she received Flulaval, GlaxoSmithKline for prophylaxis.  Following vaccination with Flulaval, she did not get the response she expected and is concerned because she did not exhibit an adverse event.				Y					U				UNK	OTH	OTH		Unknown	No relevant history reported.  The healthcare professional did indicate that the subject had previously received influenza vaccinations.  Reactions experienced with previous influenza vaccinations included a bump at the injection site.  One time she did not get a bump after administration of influenza vaccine and she was told that there was a bad lot and she received an additional dose.		A0689852A	1						1	Injection site mass	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0301353	12/21/2007	MA	73.0	73		F	12/14/2007	This case was reported by a pharmacist and described the occurrence of swelling of eyelid in a 64-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  The subject's medical history included osteoporosis.  Concurrent medications included ibuprofen and ibandronate sodium (Boniva) taken after the Fluarix.  On 13 October 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown).  The vaccination was given between 11:00 am and 3:00 pm.  No other vaccinations were given on 13 October 2007.  Three days after vaccination with Fluarix, on 16 October 2007, the subject experienced swelling of left eyelid to the point that her left eye is nearly swollen shut.  The subject consulted with a healthcare professional regarding this event.  She was seen by her physician and was prescribed Tobradex eye ointment.  At the time of reporting the events were unresolved.  As of 24 October 2007, her eyelid was still nearly swollen shut and not improved.  The pharmacist considered the events were probably related to vaccination with Fluarix.									N	10/13/2007	10/16/2007	3	UNK	OTH	PVT	ibuprofen, ibandronate sodium	Unknown	Osteoporosis; it was not known if the subject had experienced any reactions with previous influenza vaccinations.		A0690137A	1						1	Eyelid oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301354	12/21/2007					F	12/14/2007	This case was reported by a consumer and described the occurrence of puffiness in a female subject of unspecified age who was vaccinated with an unspecified GlaxoSmithKline influenza virus vaccine for prophylaxis.  The reporter is the subject.  The reporter was unsure whether the administered influenza virus vaccine was Fluarix or Flulaval.  A physician or other health care professional has not verified this report.  The subject reported that she had received a GSK influenza virus vaccine in 2006 and experienced the same reaction she experienced following administration of the GSK influenza virus vaccine in 2007, described as puffiness in her hands, shoulder, and feet.  In 2007, the subject received unspecified dose of influenza virus vaccine (unknown).  At an unspecified time following the administration of influenza virus vaccine, the subject experienced puffiness in her hands, shoulder and feet.  The subject was seen at a physician's office.  At the time of reporting the outcome of the events was unspecified.				Y					U				UNK	OTH	OTH		Unknown			A0690172A	1						1	Oedema peripheral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0301359	12/21/2007					U	12/14/2007	This case was reported by a consumer and described the occurrence of pain in the extremity in a subject of unspecified age and gender who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of Fluarix (unknown).  At an unspecified time after vaccination with Fluarix, the subject experienced pain in the extremity where the vaccine was given.  At the time of reporting the event had been ongoing for two weeks following vaccine administration.  No further details were reported.									U				Unknown	OTH	OTH		Unknown			A0690350A	1						1	Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301360	12/21/2007	CA				M	12/14/2007	This case was reported by a physician (also the subject) and described the occurrence of injection site hemorrhage in an adult male subject who was vaccinated with Fuarix, GlaxoSmithKline for prophylaxis.  On 16 October 2007, in the early afternoon, the subject (the physician) received unspecified dose of Fluarix at 0.5ml in the left arm.  On 16 October 2007, upon removal of the needle, 1/8th on an inch of blood ran down the physician's arm.  The event resolved with compression on 16 October 2007.  The physician reported that the reaction was small and it was not serious.  He did not want his information in a database.  No further information available.									Y	10/16/2007	10/16/2007	0	Unknown	PUB	OTH		Unknown	The subject has previously received flu shots with no problems.		A0690382A	1						1	Injection site haemorrhage	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301361	12/21/2007	TX				F	12/14/2007	This case was reported by a healthcare professional and described the occurrence of pain in a female subject aged 30-40's who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  On 9 October 2007 the subject received 1st dose of Fluarix 0.5 ml in the right arm.  On 9 October 2007, at an unspecified time after vaccination with Fluarix, the subject experienced pain.  At the time of reporting the outcome of the event was unspecified.  The event occurred in five different female subjects.									U	10/09/2007	10/09/2007	0	UNK	OTH	OTH		Unknown	It was reported that the subject has not previously received any flu shots.		A0690409A	1						1	Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301362	12/21/2007	TX				F	12/14/2007	This case was reported by a healthcare professional and described the occurrence of pain in a female subject aged 30-40's who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  On 9 October 2007 the subject received 1st dose of Fluarix 0.5 ml in the right arm.  On 9 October 2007, at an unspecified time after vaccination with Fluarix, the subject experienced pain.  At the time of reporting the outcome of the event was unspecified.  This event occurred in five different female subjects.									U	10/09/2007	10/09/2007	0	UNK	OTH	OTH		Unknown	It was reported that the subject has not previously received any flu shots.		A0690410A	1						1	Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301363	12/21/2007	TX				F	12/14/2007	This case was reported by a healthcare professional and described the occurrence of pain in a female subject aged 30 - 40's who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  On 9 October 2007 the subject received 1st dose of Fluarix 0.5 ml in the right arm.  On 9 October 2007, at an unspecified time after vaccination with Fluarix, the subject experienced pain.  At the time of reporting the outcome of the event was unspecified.  This event occurred in five different female subjects.									U	10/09/2007	10/09/2007	0	Unknown	OTH	OTH		Unknown	It was reported that the subject has not previously received any flu shots.		A0690411A	1						1	Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301364	12/21/2007	TX				F	12/14/2007	This case was reported by a healthcare professional and described the occurrence of pain in a female subject aged 30-40's who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  On 9 October 2007 the subject received 1st dose of Fluarix 0.5 ml in the right arm.  On 9 October 2007, at an unspecified time after vaccination with Fluarix, the subject experienced pain.  At the time of reporting the outcome of the event was unspecified.  This event occurred in five different female subjects.									U	10/09/2007	10/09/2007	0	UNK	OTH	OTH		Unknown	It was reported that the subject has not previously received any flu shots.		A0690412A	1						1	Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301365	12/21/2007	TX				F	12/14/2007	This case was reported by a healthcare professional and described the occurrence of pain in a female subject aged 30-40's who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  On 9 October 2007 the subject received 1st dose of Fluarix 0.5 ml in the right arm.  On 9 October 2007, at an unspecified time after vaccination with Fluarix, the subject experienced pain.  At the time of reporting the outcome of the event was unspecified.  This event occurred in five different female subjects.									U	10/09/2007	10/09/2007	0	UNK	OTH	OTH		Unknown	It was reported that the subject has not previously received any flu shots.		A0690413A	1						1	Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301366	12/21/2007	CA				F	12/14/2007	This case was reported by a physician and described the occurrence of second degree burns at the injection site in an adult (50 plus years of age) female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  Concurrent medications were not specified.  On 9 October 2007 the subject received unspecified dose of Fluarix in an unknown arm.  Within a few days of vaccination with Fluarix, the subject developed second degree burns at the injection site.  The subject was treated with a prescribed burn cream and the event improved.				Y					N	10/09/2007			UNK	OTH	OTH	Unknown	Unknown	It was reported that the subject has a medical history of unspecified immune problems.  The subject has received a kidney transplant.  The subject has previously received flu shots with no reactions documented.		A0690635A	1						1	Burns second degree	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU303AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0301367	12/21/2007	VA	65.0	65		F	12/14/2007	This case was reported by a consumer and described the occurrence of altered vision in a 65-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  A physician or other health care professional has not verified this report.  On 23 October 2007 at 16:00 the subject received a dose of Fluarix in the left arm.  On 23 October 2007, the same day of vaccination with Fluarix, the subject experienced left eye vision changes, swelling all over, sickness in the stomach and neck tightness.  All events resolved on 24 October 2007 with the exception of sickness in the stomach which remained unresolved at the time of reporting.									N	10/23/2007	10/23/2007	0	Unknown	OTH	PVT		Unknown			A0690640A	1						1	Muscle tightness; Stomach discomfort; Swelling; Visual disturbance	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301368	12/21/2007	CA				F	12/14/2007	This case was reported by a consumer and described the occurrence of injection site rash in a female subject of unspecified age who was vaccinated with Fluarix for prophylaxis. A physician or other health care professional has not verified this report. On 18 October 2007, the subject received unspecified dose of Fluarix (unknown). In October 2007, on or after 18 October 2007 and on or before 20 October 2007, less than one week after vaccination with Fluarix, the subject experienced a rash in the general area of the injection. At the time of reporting the outcome of the event was unspecified.									U	10/18/2007			UNK	OTH	OTH		Unknown			A0690645A	1						1	Injection site rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3070~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301369	12/21/2007	MA	48.0	48		F	12/14/2007	This case was reported by a healthcare professional and described the occurrence of pityriasis rosea in a 48-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  The subject's medical history included autoimmune disease for 25 years and drug allergies to erythromycin, minocycline, contrast dye, codeine, betadine and iodine.  Concurrent medications included Hydroxychloroquine sulphate (Plaquenil), Thyroxine sodium (Synthroid) and Montelukast sodium (Singulair).  On 15 October 2007 at 08:00 the subject received unspecified dose of Fluarix (.5 ml, unknown, left arm).  Fifteen minutes after vaccination with Fluarix, the subject experienced itching at the injection site.  She also experienced unspecified itching fifteen minutes after vaccination.  A couple of hours later, she experienced a rash at the injection site.  During the evening, the rash had gone down her arm and back.  One to two days after vaccination, the rash had spread to her stomach and chest.  The rash was described as being scaly and irregular.  The reporter thinks that it is pityriasis rosea.  The reporter considered that the reaction was systemic.  Medical attention was required at the physician's office.  The subject was treated with hydrocortisone (Hydrocortison) and fexofenadine hydrochloride (Allegra).  At the time of reporting the events were unresolved.  The healthcare professional considered the scaly, irregular rash, pityriasis rosacea and itching were probably related to vaccination with Fluarix.  Follow-up received on 27 November 2007 via the healthcare professional who is also the subject.  She reported that she was diagnosed with pityriasis rosacea.  She reported that the events improved.  She considered that the events were not serious and were possibly related to the use of Fluarix.  She noted that she had received Fluarix before and did not experience any adverse events following previous vaccinations.				Y					N	10/15/2007	10/15/2007	0	Unknown	PUB	PVT	Hydroxychloroquine SO4 Thyroxine sodium Montelukast sodium	Unknown	Allergic to betadine, allergy to contrast dye, allergy to erythromycin, allergy to minocycline, autoimmune disease, codeine allergy, drug allergy, iodine allergy.  History:  Allergic to erythromycin, minocycline, contrast dye, codeine, betadine and iodine.  Diagnosed with the autoimmune disease 25 years ago.  Severe reaction to MMR specified as arthralis reaction in 1978.  The subject had previously received Fluarix and influenza vaccinations and had not experienced any adverse events.  No alcohol or tobacco use.		A0691079A	1						1	Injection site pruritus; Pityriasis rosea; Rash generalised	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA309AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0301370	12/21/2007	CT	29.0	29		F	12/14/2007	This case was reported by a consumer and described the occurrence of allergic reaction in a 29-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  The reporter is the subject.  A physician or other health care professional has not verified this report.  The subject reported that she had not relevant medical history.  The subject had previously received influenza immunizations with no adverse events.  The subject had no adverse events following receipt of any previous vaccinations.  Concurrent medications included Lexapro and bupropion hydrochloride (Wellbutrin).  On 1 November 2007 at 1:00 p.m., the subject received unspecified dose of Fluarix (unknown, left arm).  On the afternoon of 2 November 2007, 1 day after vaccination with Fluarix, the subject experienced an allergic reaction.  The subject described the allergic reaction as red, swollen and itchy hives over her body from the neck down.  The subject considered the events to be disabling and to be jeopardizing or requiring intervention.  On November 3, 2007 the subject was seen by a physician and was treated with diphenhydramine hydrochloride (Benadryl) injection, and Prednisone injection.  On November 4, 2007, the hives had spread to the face.  The subject returned to the physician's office and received 2 adrenaline (Epinephrine) injections plus Benadryl and Prednisone injections.  At time of initial reporting, 5 November 2007, the subject stated that the hives on her face had resolved but she still has the hives on her body.				Y				Y	N	11/01/2007	11/02/2007	1	UNK	OTH	PVT	Lexapro, bupropion hydrochloride	Unknown	The subject reported that she had no relevant medical history.  The subject had previously received influenza immunizations with no adverse events.  The subject had no adverse events following receipt of any previous vaccinations.		A0691800A	1						1	Hypersensitivity; Rash erythematous; Rash generalised; Rash pruritic; Swelling; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Disabling	Influenza
0301371	12/21/2007		52.0			F	12/14/2007	This case was reported by a physician and described the occurrence of injection site reaction in a 52-year-old female subject who was vaccinated with influenza virus vaccine (anti flu vaccine, manufacturer unspecified) for prophylaxis.  Concurrent medications included montelukast sodium (Singulair), conjugated estrogens (Premarin), mometasone furoate (Nasonex) and unknown Zalaten.  On 25 October 2007 the subject received unspecified dose of anti flu vaccine (unknown, right arm).  On 25 October 2007, at an unknown time after the vaccination with anti flu vaccine, the subject experienced injection site reaction, injection site redness and swelling injection site.  The reporting physician stated the person administering the vaccine may have hit the bursa (bursa injury).  Medical attention was required at the physician's office.  At the time of reporting the events were worse.  The physician considered the events were possibly related to vaccination with anti flu vaccine.									U	10/25/2007	10/25/2007	0	UNK	OTH	OTH	montelukast sodium, conjugated estrogens, mometasone furoate, unknown	Unknown			A0693989A	1						1	Bursa injury; Injection site erythema; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0301372	12/21/2007	CO				U	12/14/2007	This case was reported by a pharmacist and described the occurrence of abnormal taste in mouth in several subjects of unspecified age and gender who were vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  On unspecified dates several subjects received unspecified dose of Fluarix (unknown).  At an unknown time after vaccination with Fluarix, the subjects experienced a latex taste in mouth.  At the time of reporting the outcome of the event was unspecified.									U				UNK	OTH	OTH		Unknown			A0694004A	1						1	Dysgeusia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301373	12/21/2007	MO				F	12/14/2007	This case was reported by a healthcare professional and described the occurrence of inappropriate dose of vaccine administered in an adult female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  On 12 November 2007 at 12:00 the subject received an unspecified dose of Fluarix (unknown, left arm).  The subject experienced inappropriate dose of vaccine administered and accidental exposure as part of the dose ran down the subject's arm during the injection, and pharmaceutical product complaint.  The nurse reported that she believed that the needle may have become loose when she removed the needle cover prior to the injection causing part of the dose to leak out during the injection.  She was using a Luer-lok needle with the pre-filled syringe.  There were no clinical events reported but the nurse is concerned that the subject may not be protected with only the partial dose.  She plans to repeat the dose.  At the time of reporting the outcome of the pharmaceutical product complaint was unspecified.									U	11/12/2007	11/12/2007	0	UNK	PVT	PVT		Unknown	The subject had previously received influenza vaccinations and had not experienced any reactions with the previous dose of influenza vaccine.  The subject had also not experienced any adverse events with previous vaccinations.		A0694278A	1						1	Accidental exposure; Medical device complication; Underdose	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLA305BA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301374	12/21/2007	KY	27.0	27		F	12/14/2007	This case was reported by a pharmacist and described the occurrence of welt in a 27-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  The subject had no relevant medical history.  There were no concurrent medications.  The subject had previously received immunization with influenza virus vaccine.  The subject reported to the healthcare professional that, 3 to 4 years ago, the same rash occurred but the subject was unsure if this occurred in relation to a flu shot.  On 31 October 2007, the subject received unspecified dose of Fluarix (.5 ml, unknown, right arm).  The healthcare professional reported that this was the 1st dose of Fluarix.  On 6 November 2007, 6 days after vaccination with Fluarix, the subject experienced raised, warm, itchy raised rash that produced welts and hives on her arms, legs, behind, and knees.  This rash occurred in the night when the subject was asleep and began to resolve when she applied hydrocortisone.  However, it returned in the nighttime during sleep.  This has occurred for the past 2 nights.  The pharmacist considered the events were clinically significant (or requiring intervention).  At the time of reporting the events were unresolved. Follow-up received on 25 February 2008 via the healthcare professional who was alos the subject. On 06 November 2007, six days after vaccination with FLUARIX, the subject experienced a welt, raised rash and itching as previously reported. Two days later, on 08 NOvember 2007, the symptoms resolved. This healthcare professional considered that the events were not serious and possibly related to the use of FLUARIX. She also considered that she could have reacted to other sources besides the flu vacicne, such as laundry detergent.									Y	10/31/2007	11/06/2007	6	UNK	PVT	PVT	No concurrent medication	Unknown	The subject had no relevant medical history.  The subject reported to the healthcare professional that, 3 to 4 years ago, the same rash occurred but the subject was unsure if this occurred in relation to a flu shot.		A0694295A	1						1	Rash; Rash papular; Rash pruritic; Skin warm; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301375	12/21/2007	WI	37.0			F	12/14/2007	This case was reported by a healthcare professional and described the occurrence of arm pain in a 37-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  The reporter is the subject.  The subject had no relevant medical history.  There were no concurrent medications.  The subject reported that she had received influenza virus vaccine in previous years with no subsequent adverse events.  On 6 November 2007 at 7:45 a.m., the subject received unspecified dose of Fluarix (unknown, left arm).  The healthcare professional reported that the vaccine was administered into the bone which was the incorrect route of administration.  On 6 November 2007, less than one day after vaccination with Fluarix, the subject experienced arm pain.  At the time of reporting the outcome of the arm pain was unspecified.									U	11/06/2007	11/06/2007	0	UNK	PUB	OTH	No concurrent medication	Unknown	The subject had no relevant medical history.  The subject reported that she had received influenza virus vaccine in previous years with no subsequent adverse events.		A0694315A	1						1	Incorrect route of drug administration; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301376	12/21/2007	NY	29.0			F	12/14/2007	This case was reported by a healthcare professional and described the occurrence of forearm erythema in a 29-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  Concurrent vaccination included Fluarix, GlaxoSmithKline, correct dosage administered on 2 November 2007.  Concurrent medications included Tuberculin (tuberculosis skin test).  On 2 November 2007 at 09:00 the subject inadvertently received a dose of Fluarix at 0.1 ml, subcutaneously in an unknown forearm.  The subject was supposed to have received a Tuberculin skin test and the nurse noted that she inadvertently administered an incorrect dose of Fluarix via the wrong route of administration instead.  That same day, on 2 November 2007, the nurse repeated the Tuberculin skin test appropriately in the other forearm and also administered a correct dose of 0.5 ml Fluarix in an unknown deltoid.  On 3 November 2007, 24 hours after vaccination with Fluarix, the subject experienced mild forearm erythema and slight swelling where the Fluarix was administered subcutaneously.  At the time of reporting, the events were improving with a mild pink area and decreased swelling by 5 November 2007.  The healthcare professional considered the forearm swelling and redness were probably related to vaccination with Fluarix.  Follow-up information was received on 29 November 2007.  The healthcare professional reported she inadvertently administered 0.1 ml of Fluarix as a Tuberculin skin test (PPD).  The healthcare professional stated, no PPD was placed ever in either forearm.  The full dose 0.5 ml of Fluarix was then administered to the left deltoid.  On 05 November 2007, the subject reported her forearm was a mild shade of pink and the swelling was very minimal.  The subject was concerned about receiving more than 0.5 ml of Fluarix and if she would experience an adverse reaction.  The healthcare professional explained to the subject she was experiencing symptoms that were expected from the vaccine administered in the wrong location.  As of 22 November 2007, no further complaints were noted by the subject.									Y	11/02/2007	11/03/2007	1	UNK	PUB	OTH		Unknown			A0694316A	1						1	Erythema; Incorrect dose administered; Incorrect route of drug administration; Oedema peripheral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~2~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301379	12/21/2007	WA	3.0	3		F	12/14/2007	This case was reported by a healthcare professional and described the occurrence of crankiness in a 3-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix GlaxoSmithKline) for prophylaxis. There were no concurrent medications. The subject had no relevant medical history. The subject had no adverse events following the receipt with any prior immunizations. On 2 November 2007 the subject received unspecicifed dose of Fluarix (unknown, left thigh). As a result of vaccination with Fluarix, the subject experienced vaccination error, decried as adult by the healthcare professional. On 2 November 2007, less than one day after vaccination with Fluarix, the subject experienced crankiness. The healthcare professional reported on 7 November 2007 that the subject was unusually cranky since receiving the Fluarix on Friday (2 November 2007) and that the crankiness had improved but the subject was still cranky.									N	11/02/2007	11/02/2007	0	UNK	PVT	PVT	No concurrent medication	Unknown	The subject had no relevant medical history. The healthcare professional reported that one other subject inadvertently received Fluarix and experienced crankiness. Please see case A0694324A.		AO694319A	1						1	Inappropriate schedule of drug administration; Irritability	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA310AA~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301380	12/21/2007	WA	5.0	5		U	12/14/2007	This case was reported by a healthcare professional and described the occurrence of crankiness in a 5-year-old subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On 2 November the subject received unspecicifed dose of Fluarix (unknown, left thigh). As a result of the vaccination with Fluarix, the subject experienced vaccination error, described as adult by the healthcare professional. On 2 November 2007, less than one day after vaccination with Fluarix, the subject experienced crankiness. Th healthcare professional reported on 7 November 2007 that the subject was unusually cranky since receiving the Fluarix on Friday (2 November 2007) and that the crankiness has improved but the subject wad still cranky.									N	11/02/2007	11/02/2007	0	UNK	PVT	PVT		Unknown	The healthcare professional reported that one other subject inadvertently received Fluarix and experienced crankiness. Please see case A0694319A		A0694324A	1						1	Inappropriate schedule of drug administration; Irritability	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA310AA~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301381	12/21/2007	OR				F	12/14/2007	This case was reported by a healthcare professional and described the occurrence of influenza in an adult female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On a unspecified date the subject received unspecified dose of Fluarix (unknown). One and a half weeks later after vaccination with Fluarix, the subject experienced influenza and lack of efficacy. At the time of reporting the events were resolved.									Y				UNK	OTH	OTH		Unknown			A0694332A	1						1	Influenza; Vaccination failure	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301382	12/21/2007	HI	74.0	74		M	12/14/2007	This case was reported by a physician and described the occurrence of influenza in 74-year-old male subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. Concurrent medications included Unknown (Unspecified medications). On 3 October 2007, the subject received unspecified dose of Fluarix (.5 ml, subcutaneous, unknown). The reporting physician believed the subject's dose of Fluarix was inadvertenly administered subcutaneously rather than intramuscularly and thus was not effective. At an unspecified time after vaccination with Fluarix, the subject experienced two occurrences of influenza and lack of efficacy. The subject did not require any treatment. At the time of reporting the outcome of the events were unspecified.									U	10/03/2007	10/03/2007	0	UNK	PVT	PVT	Unknown	Unknown	The subject currently takes many concomitant medications that were not provided at the time of reporting. At the time of reporting, the reporter declined to provide the subject's relevant medical history. It was unknown if the subject had received previous influenza vaccinations.		A0694338A	1						1	Influenza; Vaccination failure	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~SC~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301383	12/21/2007					U	12/14/2007	This case was reported by a consumer and described the occurrence of feeling unwell in a adult subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Influenza vaccine, manufacturer unspecified) for prophylaxis. A physician or other health care professional has not verified this report. The subject was the reporter's physician. On an unspecified date the subject received unspecified dose of Influenza vaccine (unknown). At an unspecified time after vaccination with Influenza vaccine, the subject experienced feeling unwell. At the time of reporting the outcome of the event was unspecified.									U				UNK	OTH	OTH		Unknown			A0695034A	1						1	Malaise	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301384	12/21/2007	NJ	41.0	41		F	12/14/2007	This case was reported by a healthcare professional and described the occurrence of bad taste in a 41-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On 7 November 2007 at 16:45 the subject received unspecified dose of Fluarix (.5 ml, unknown, left arm). Approximately 5 minutes after vaccination with Fluarix, the subject experienced bad taste, pain, vomiting and headache. On 10 November 2007, the events were resolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.  Follow-up information received on 13 December 2007 indicated that the subject felt that the events were related to treatment with FLUARIX, the health care professional did not. The events resolved.									Y	11/07/2007	11/07/2007	0	UNK	PVT	OTH		Unknown	No relevant medical history reported. The subject had previously received influenza vaccinations and no adverse events were reported. No adverse events were reported following receipt of immunizations.		A0695041A	1						1	Dysgeusia; Headache; Pain; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA318AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301385	12/21/2007	NC	54.0	54		F	12/14/2007	This case was reported by a consumer and described the occurrence of flu like symptoms in a 54-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. On 6 November 2007 at 15:30 the subject received unspecified dose of Fluarix (unknown, right arm). On 7 November 2007, 1 day after vaccination with Fluarix, the subject experienced flu like symptoms, chills, congestion (nos), fever, sore throat, pain and headache. The patient required medical attention at her physician's office. At the time of reporting the events were improved.									N	11/06/2007	11/07/2007	1	UNK	OTH	OTH		Unknown	The subject had previously received influenza vaccinations and had not experienced any adverse events.		A0695196A	1						1	Chills; Headache; Influenza like illness; Pain; Pharyngolaryngeal pain; Pyrexia; Respiratory tract congestion	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301387	12/21/2007		49.0			F	12/14/2007	This case was reported by a healthcare professional (also the subject and consumer) and described the occurrence of a 49-year-old female subject feeling strange following vaccination with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On November 2007 it was reported that the subject received unspecified dose of Fluarix and approximately one to two hours following vaccination reported feeling strange with waves of nausea, scratchy throat and heavy headedness which continued three hours after the injection and had not resolved at the time of reporting at 15:00 hours. On 7 November 2007, at 09:00 hours, the subject reported that her ears were burning and she had nausea all night long. Her throat remained sore and scratchy. At the time of reporting the events were unresolved. Follow-up received on 10 January 2008 via the nurse. SHe reported that on 08 November 2007 she experienced strange feeling, nausea, scatchy throat, heavy  headedness. Oora burning and sore throat. The events resolved on 13 November 2007. The reporter noted that the events were not serious.									Y		11/08/2007		UNK	OTH	OTH		unknown			A0695204A	1						1	Ear discomfort; Feeling abnormal; Head discomfort; Nausea; Oropharyngeal pain; Throat irritation	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301389	12/21/2007	CA	65.0	65		M	12/14/2007	This case was reported by a consumer and described the occurrence of tiredness in a 65-year-old male subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medical conditions included diabetes and hypertension. Concurrent medications included Diabetes medication and Antihypertensive (Hypertension med). On 13 October 2007 at 13:15 the subject received unspecified dose of Fluarix (.5 ml, unknown). On 14 October 2007, 1 day after vaccination with Fluarix, the subject experienced tiredness. on 14 October 2007, the event was resolved.									Y	10/13/2007	10/14/2007	1	UNK	PVT	PVT	Diabetes medication; Antihypertensive	DIABETES, HYPERTENSION	It was unknown if the subject had previously received influenza vaccinations or experienced adverse events. It was unknown if the subject had adverse events following receipt of prior immunizations.		A0695421A	1						1	Fatigue	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301392	12/21/2007	CO				U	12/14/2007	This case was reported by a healthcare professional and described the occurrence of taste abnormality in an unknown number of subjects of unspecified ages and gender who were vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  Since approximately two weeks prior to this report, when the hospital's clinics started administering Fluarix.  A small number of subjects received an unspecified dose of Fluarix (.5 ml, unknown) and at an unspecified time after the vaccination, the subjects experienced latex taste in their mouths (taste abnormality).  No other adverse events were reported.  The reporter could not isolate any cases to one particular clinic and has not identified these reports to be a specific lot number.  At the time of reporting, the outcome of the event was unspecified.									U				Unknown	PUB	OTH		Unknown	It was unknown if the subjects had previously received influenza vaccinations or experienced adverse events.  It was unknown if the subjects had adverse events following receipt of prior immunizations.  Relevant medical history was unknown.		A0695451A	1						1	Dysgeusia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA311BA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301395	12/21/2007	IN	31.0	31		F	12/14/2007	This case was reported by a pharmacist and described the occurrence of bursa injury in a 31-year-old female subject who was vaccinated with Fluarix (GlaxoSmithKline) for prophylaxis.  On the morning of 7 November 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) that was mistakenly administered into the bursa and in the top of the shoulder rather than intramuscularly.  On 7 November 2007, at an unspecified time after vaccination with Fluarix, the subject experienced bursa injury and intramuscular formulation administered by other route.  The subject required medical attention at the doctors office and was treated with a Medrol dose pack (Medrol Pak) and ibuprofen.  At the time of reporting the events were unresolved.  The pharmacist considered the events were possibly related to vaccination with Fluarix. Follow-up received on 25 January 2008 via the pharmacist. He reported that on 08 November 2007, the subject experienced a partial tear and inflammation of the rotator cuff tendon from the misplacement of the injection and secondary axillary lymphadenopathy. He also confirmed that on 08 November 2007, the subject experienced a bursa injury and intramuscular formulation administered by another route. He noted that the MRI indicated administration likely occurred into the infraspinatus tendon/bursa and local inflammation of tendon along with partial tear likely at injection site. The subject was treated with a MEDROL 4 mg dosepack and referred to physical therapy. He noted that the partial tear and inflammation of the rotation cuff tendon and bursa injury improved and he considered that these events were not related to the use of FLUARIX. He reported that the secondary axillary lymphadenopathy resolved on 07 January 2008 and he considered that it was possibly related on the use of FLUARIX. He considered that the events were not serious. The reporter indicated that the events could have been associated with the erroneous administration based on the result of the MRI.				Y					N	11/07/2007	11/07/2007	0	UNK; MRI scan indicated administration likely occurred into the infraspinatus tendon/bursa and local inflammation of tendon along with partial tear likely at injection site	OTH	PVT		Unknown; no concurrent illnesses	No relevant medical history, or allergies. No concurrent medications. No alcohol or tobacco use.		A0696102A	1						1	Bursa injury; Incorrect route of drug administration; Inflammation; Lymphadenopathy; Nuclear magnetic resonance imaging abnormal; Rotator cuff syndrome	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA315CA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0301396	12/21/2007	NC	35.0	35		F	12/14/2007	This case was reported by a healthcare professional and described the occurrence of injection site redness in a 35-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On 13 November 2007 at 10:59 the subject received a dose of Fluarix at 0.5 ml in the right arm. On 14 November, 1 day after vaccination with Fluarix, the subject developed a 8 x 6 cm area of redness at the injection site. No treatment was required. At the time of reporting the events was unresolved. Follow-up received on 11 December 2007 via the nurse. The nurse reported that the subject had a history of hypertension. It was noted that the subject had no previous reaction to influenza vaccinations. It was reported that the injection site redness resolved on 19 November 2007. The nurse considered that the injection site redness was related to the injection site redness was related to the use of FLUARIX. She also considered that the events were not related to the use of FLUARIX. She also considered that the events were not serious.									N	11/13/2007	11/14/2007	1	UNK	PVT	PVT		Unknown	The subject has previously received flu shots and reported soreness at the injection site. The subject also experienced soreness following previous vaccinations such as possibly tetanus.		A0696119A	1						1	Injection site erythema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA298AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301397	12/21/2007	NY	0.87	0	.9	M	12/14/2007	This case was reported by a healthcare professional and described the occurrence of low grade fever in a 10-month-old male subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  Concurrent medical conditions included healthy baby.  No concurrent medications.  The subject had experienced no adverse events following previous vaccinations.  On 27 November 2007 the subject received unspecified dose of Fluarix (.5 unknown) and experienced a vaccination error.  On 29 November 2007, 2 days after vaccination with Fluarix, the subject experienced low grade fever, diarrhea and runny nose.  No other vaccinations were given on 27 November 2007.  Medical attention was not required.  At the time of reporting the runny nose had improved and the fever and diarrhea were unresolved. Follow-up information was received on 17 December 2007, via healthcare professional, who reported the subject received the wrong dose and wrong drug. One day later on 28 November 2007, the subject experienced the previously reported events that resolved 04 December 2007. The healthcare professional considered the events related to erroneous administration. The reporter was positive the baby was given to much and not the correct dose.									Y	11/27/2007	11/28/2007	1	Unknown	PVT	PUB		Unknown	Healthy baby.  No adverse events following previous vaccinations.  No concurrent medications.		A0697309A	1						1	Diarrhoea; Incorrect drug dosage form administered; Pyrexia; Rhinorrhoea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA321CA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301398	12/21/2007	GA	14.0	14		M	12/14/2007	This case was reported by a healthcare professional and described the occurrence of exacerbation of pain in muscles in a 14-year-old male subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. The subject's medical history included leg weakness and sore muscle. Subject participated in baseball, basketball and weight training. Concurrent medications included cold and sinus medication. On 19 November 2007 at 19:42 the subject inadvertently received unspecified dose of Fluarix (.5 ml, unknown, right arm) and experienced a vaccination error. He was supposed to receive an influenza vaccine that was approved for  14 year old subjects. At an unspecified time after vaccination with Fluarix, on or before 30 November 2007, the subject experienced exacerbation of pain in muscles and muscle weakness aggravated. At the time of reporting the exacerbation of pain in muscles and muscle weakness aggravated were unresolved. The healthcare professional considered that the exacerbation of pain in muscles and muscle weakness aggravated were possibly related to vaccination with Fluarix. Follow-up received on 09 January 2008 via the healthcare professional. She reported that two days following vaccination with FLUARIX (intramuscular), on 21 November 2007, the subject experienced exacerbation of pain in muscles and muscle weakness aggravated. It was also reported that the events had improved by 10 December 2007. In the relevant medical history section of the adverse event form, it was noted that leg weakness and sore muscle started on 21 November 2007 and resolved on 10 December 2007. The reporter considered that the events were not serious and possibly related to the use of FLUARIX. The healthcare professional also considered that the events could have been associated with the subject's participation in weight training, baseball and basketball practices.									N	11/19/2007	11/19/2007	0	UNK	PVT	PVT	Cold medication; Cold medication	Unknown	Subject participates in baseball, basketball and weight training. The mother mentioned that he did have sore muscles and wekness in his legs before he received the influenza vaccine.		A0697324A	1						1	Inappropriate schedule of drug administration; Muscular weakness; Myalgia; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA312BA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301399	12/21/2007	SC				U	12/14/2007	This case was reported by a physician via a representative and described the occurrence of an unspecified adverse event in a subject of unspecified age and gender who was vaccinated with Fluarix. On an unspecified date the subject received unspecified dose of Fluarix (unknown). At an unspecified time after vaccination with Fluarix vaccine, the subject experienced an unspecified adverse event. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 13 December 2007 via a healthcare professional who reported that the subject was a 70-year-old male who was vaccinated with FLULAVAL (Glaxosmithkline) on 29 October 2007. The subjects's medical history included adult onset diabetes mellitus, gastroesophageal reflux disease and smoking. On 29 October 2007 the subject received a dose of FLULAVAL. On the same day that the subject was vaccinated with FLULAVAL, the subject experienced extensive swelling of the vaccinated limb, pitting edema, injection site redness, hotness at injection site, and fatigue. The healthcare professional described the swelling as edema +3 from shoulder to elbow. As of 02 November 2007, the reporter stated that the events had resolved on their own. The reporting healthcare professional considered the events to be related to vaccination with FLULAVAL.									U				UNK	PVT	OTH		Unknown			A0697363A	1						1	Adverse event; Fatigue; Injection site erythema; Injection site swelling; Injection site warmth; Oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0300777	12/22/2007	MN	1.0	0	1	F	12/22/2007	Fever to 103.7, eight days after MMR, varicella, Comvax, influenza vaccines				Y					Y	12/12/2007	12/19/2007	7	none	PVT	PVT	ranitidine	no	GERD			1						1	Pyrexia	FLU3~SANOFI PASTEUR~UT2477AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0537U~UNK~IM~~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0281U~UNK~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1002U~UNK~SC~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0300778	12/22/2007	VA	6.0	6		F	12/22/2007	Widespread small hives ~2.5 hours after vaccine administration									Y	12/20/2007	12/20/2007	0		PVT	PVT						1						1	Urticaria	FLU3~SANOFI PASTEUR~U2497AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300779	12/22/2007	VA	54.0	54		F	12/22/2007	Fever up to 101 2 days after injection of Pneumovax and inactivated Fluvirin L deltoid. Within 5 days a blistering rash started at the injection site and around her left breast..a cellulitis type reaction. She had pain under her breast and in her left axilla and at the injection site that lasted more than 2 weeks...all sx eventually resolved.									Y	12/02/2007	12/04/2007	2		PVT	PVT	none	none	none			1						1	Axillary pain; Breast pain; Cellulitis; Injection site pain; Injection site rash; Injection site vesicles; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81111~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~09894~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0300780	12/22/2007	MO	21.0	21		F	12/22/2007	On 11/5/07 at approximately 11am I had a Grand Mal seizure for the first time in my life with no prior symptoms or signalment. I was taken to the emergency room at the University of Missouri Hospital. In the emergency room at 2:15pm I had another seizure, a complex partial with secondary generalization seizure. I had a MRI, CAT scan and EEG, all of which were negative. I was treated with Dilantin 100mg 3 times per day, but have been switched to carbamazepine (Tegretol) 300mg orally per day for at least 6 months. I had to stay in the hospital three additional days due to thrombophlepitis of my upper left arm where a cathether had been placed. I was treated with Ibuprofen and Bactrim DS tablet orally for the thrombophlepitis. 12/26/07-records received for DOS 11/10-11/11/07-DC DX: Seizure.Seen in ED on 11/5 and 11/6 for new onset of sezure. After visit to ED and subsequent DC she was found near the pharmacy hypersomnolent. In ED on 11/5/07 observed generalized tonic-clonic seizure. Developed pruritis, rash, left orbital swelling presumably from Vancomycin.  02/03/2010 Petite Mal Seizure 12/21/07.				Y	Y	1			N	10/29/2007	11/05/2007	7	CAT scan, MRI and EEG of head are negative. 12/26/07-records received-MRI brain negative. CT head/brain negative. EEG normal.	UNK	UNK	Differin (adapalene gel) topical for acne on face. Alclometasone Dipropionate cream USP 0.05% topical for eczema on hands and legs.	None.	Eczema on hands and legs.			1						1	Complex partial seizures; Computerised tomogram normal; Electroencephalogram normal; Grand mal convulsion; Nuclear magnetic resonance imaging normal; Thrombophlebitis	FLU3~SANOFI PASTEUR~U2478AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0300783	12/23/2007	FL	15.0	15		F	12/23/2007	Entire left arm swelled 2 days after recieving 3rd Gardasil injection. Recieved ibprofen and ice.									U	12/21/2007	12/23/2007	2		PVT	PVT	Zoloft 5o mg per day, Seasonique, nexium 40 mg twice daily.	none.	esophagitis, dysmenorrhea, depression.			1						1	Oedema peripheral	FLUN3~MEDIMMUNE VACCINES, INC.~~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~~3~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0300785	12/23/2007	PA	47.0	47		F	12/23/2007	On December 3rd, my family physician, during a routine visit to receive the flu vaccine told me I needed a tetnus booster to which I agreed.  Approximately one and one half weeks later I woke up in the morning with every single solitary joint in my body stiff and aching right down to the joints in my toes.   I contacted Dr. and was told that those symptoms were not typical of the tetanus shot.  I disagree with his findings.  This arthritis and pain and stiffness of all of my joints began on or about December 14th and still persisits.  I am awakened many times during the night due to it.  It is difficult for me to get up after sitting down or driving for 15 mintues or so.  Now, two nights ago on December 21 I experience very deep aching pain in my right leg all night.  I am also experiencing sharp pains often in various parts of my body.									N	12/03/2007	12/14/2007	11	After contacting my doctor I was told that my symptoms that I explained to his nusre were not typical of the tetanus vaccine.  I am making an appointment right after Christmas to see a Rheumatologist to see what is going on here.	UNK	UNK	none	I had just finished up a cold and was at the tail end of it.  I informed the doctor of such and he said it would not affect the vaccines that day and continued to adminster both the flu and tetanus	none... Had cancer 11 years ago but no reoccurence of such since 1996.			1						1	Arthralgia; Arthritis; Joint stiffness; Pain; Pain in extremity; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0278593	12/26/2007	OH	21.0	21		M	12/26/2007	patient developed itching on palms about 12 hours after vaccines-day following vaccination patient developed hives-no other systemic symptoms.  patient had hives off/on for 3 months-none over the last 2 months.				Y					Y	05/05/2007	05/05/2007	0		MIL	MIL	none	none	none			1						2	Urticaria; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2199AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1160F~3~IM~LA~HEP B (RECOMBIVAX HB)~1|HEPA~MERCK & CO. INC.~1278F~3~IM~LA~HEP A (VAQTA)~1|FLU3~SANOFI PASTEUR~u2199AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|HEP~MERCK & CO. INC.~1160F~UNK~UN~UN~HEP B (RECOMBIVAX HB)~2|HEPA~MERCK & CO. INC.~1278F~UNK~IM~UN~HEP A (VAQTA)~2	USA	Emergency room visit	Influenza
0298364	12/26/2007	MI	0.6	0	.6	M	12/19/2007	GENERALIZED SEIZURE with Temp 102 at 11:45 PM (10/18/07) -> ER				Y					Y	10/18/2007	10/18/2007	0		PVT	PVT		URi				1						2	Blood culture negative; Convulsion; Full blood count normal; Lumbar puncture; Pyrexia; Urine analysis normal; Body temperature increased; Convulsion	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B127AA~UNK~~~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U24566A~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1435F~UNK~~~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B54007E~UNK~~~PNEUMO (PREVNAR)~1|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B127AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~2|FLU3~SANOFI PASTEUR~UT2456BA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~MERCK & CO. INC.~1435F~3~IM~LL~HIB (PEDVAXHIB)~2|PNC~PFIZER\WYETH~B54007E~3~IM~RL~PNEUMO (PREVNAR)~2	USA	Emergency room visit	Influenza
0299053	12/26/2007	VA	23.0	23		F	12/26/2007	23 yo healthy pt with acute onset of coughing, dyspnea, glossal/pharyngeal edema, pruritis and hives 20 minutes after receiving 4 immunizations at immunization clinic (Yellow Fever, Influenza,  Hepatitis A and B).  Pt was sent to healthcare facility where she was treated with Oxygen, Benadryl 50mg x 2, Solumedrol 125mg x2, Albuterol neb, and epinephrine 0.3mg subcut, 2L NS.  Pt states she began to feel better after treatment and had no recurrence of symptoms.  After pt was stabilized she was transferred to hospital for observation and was than transferred for continued observation for refractory symptoms.  12/27/2007 MR received for ER visit 12/7-8/2007 with D/C DX: Anaphylactic Reaction to Immunization.  Pt developed acute onset of coughing, dyspnea, glossal/pharyngeal edema, hives and pruritis w/in 20 minutes of 4 vax. Pt txd with Epi, Benadryl, Solumedrol and albuterol.  Developed more hives. Observed o/n with no refractory sx.				Y	Y	1			Y	12/07/2007	12/07/2007	0		UNK	UNK	Zyrtec, Zantac	None	None			1						3	Dyspnoea; Throat tightness; Urticaria; Cough; Dyspnoea; Pharyngeal oedema; Pruritus; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500502P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB107BA~3~IM~RA~HEP A + HEP B (TWINRIX)~1|YF~SANOFI PASTEUR~UE912AA~1~SC~LA~YELLOW FEVER (YF-VAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500502P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB094AA~1~IM~RA~HEP A + HEP B (TWINRIX)~3|YF~SANOFI PASTEUR~UE912AA~1~IM~LA~YELLOW FEVER (YF-VAX)~3	USA	Hospitalisation	Influenza
0300753	12/26/2007	LA	4.0	4		M	12/21/2007	Injection given 12/5/07.  Fever started that night into next day-104 degrees F.  Couldn't walk, knee swollen, thigh red & tender.  Went to local ER; then transported by ambulance to hospital.  They ultrasounded knee - emergency surgery to drain fluids around incision site.  Second surgery done 12/9/07 to irrigate & drain fluid buildup at incision site.  Was released Monday Dec 10th at 4pm from hospital. Per 60 day follow up: This event was very traumatic on my child. He has a huge scare on his leg and he still has dreams about it. He is scared to go to the doctor's and still gets pain in the the leg.				Y	Y	5			Y	12/05/2007	12/05/2007	0		PVT	PVT		sinus infection	none			1						2	Abasia; Body temperature increased; Injection site infection; Pyrexia; Surgery; Abasia; Incisional drainage; Injection site erythema; Injection site pain; Joint swelling; Pyrexia; Surgery; Ultrasound scan	FLU3~SANOFI PASTEUR~42436AA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0038U~1~UN~LL~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~42436AA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0038U~1~UN~LL~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0300916	12/26/2007	AZ	1.29	1	.3	F	12/21/2007	Information has been received from a physician concerning a 15 month old female with no pertinent medical history or drug reactions/allergies who on 23-OCT-2006 was vaccinated with a first dose of Hib conj vaccine (OMPC). On 18-DEC-2006, the patient was vaccinated with a second dose of ACTHIB. On 02-MAR-2007, the patient was vaccinated with a third dose of Hib conj vaccine (OMPC). Following the first three doses, the patient had no adverse side effects. On 13-DEC-2007, the patient was vaccinated with a fourth dose of PedvaxHIB (lot# 657387/0995U). Concomitant therapy included influenza virus vaccine (unspecified) and Prevnar. On 13-DEC-2007 after receiving the three vaccines the patient did not have any problems or adverse side effects. Later that same day, at approximately 6:30 PM, the father saw the child chewing on a glass Christmas ornament. He removed the ornament from the child's mouth. As he did so, he saw glass fragments in the child's mouth and he reported that he believes that he removed all of these fragments. The child then took a nap. When the child woke up, her lips were blue but then the lips turned back to a normal pink. Subsequently, the family took a trip by car. With the child in a car seat, the child began drooling and her eyes began to roll. The child appeared to be having a seizure. The child was taken to the emergency department of a local hospital and subsequently transported to a regional hospital. The child continued to have seizures. The child was incubated on a respirator and medically sedated. Presently, the child is still hospitalized in the ICU in a medically induced coma. Some blood was found in the child's stomach. Many tests have been done. This included a CAT scan of the head, blood tests, lumbar puncture, endoscopy and bronchoscopy. To date the test results have been negative. The reporter felt that lips turned blue, inappropriate schedule, seizure, medically induced coma, blood in the stomach all required hospitalization and were considered to be life threatening, disabling and an other medical event (OME). Additional information has been requested. 4/9/08-records received for DOS 12/13-12/14/07-presented after possibly ingesting a crystal ornament at home. Day of vaccination began with tonic-clonic seizure febrile, eyes deviated, drooling, tremulousness of hand. Intubated.			Y	Y	Y	2	Y	Y	N	12/13/2007	12/13/2007	0	head computed axial; diagnostic laboratory; spinal tap; endoscopy; bronchoscopy 4/9/08-records received-CT scan reveals small area of encephalomalacia lateral to right lateral ventricle. Labs: neutrophils 76, lymphocytes 13 and monocytes 8.4. CSF glucose 94, protime 18.3, cultures no growth. Skeletal survey no fractures. MRI brain right choroidal fissure cyst, othrwise unremarkable.EEG mildly abnormal because of generalized slow background activity. No epileptiform patterns demonstrated.EGD hematemesis.	OTH	OTH			None 4/9/08-records received-PMH: hospitalization for gastroenteritis.		WAES0712USA06785	1						1	Bronchoscopy; Coma; Computerised tomogram head; Convulsion; Cyanosis; Drooling; Endoscopy; Gastrointestinal haemorrhage; Gaze palsy; Inappropriate schedule of drug administration; Laboratory test; Lumbar puncture	FLU3~SANOFI PASTEUR~U2461BA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0995U~4~UN~UN~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B54016C~4~UN~LL~PNEUMO (PREVNAR)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0300928	12/26/2007	CA	24.0	24		F	12/26/2007	broke out in hives, itchness all over body, redness, swelling and warmth at site of shot.				Y					U	12/20/2007	12/20/2007	0	none	MIL	MIL	none	none	none			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Pruritus generalised; Urticaria	FLU3~SANOFI PASTEUR~u2506aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0300933	12/26/2007	NY	73.0	73		F	12/10/2007	At 10:30, patient assessed for contraindications for vaccine.  No contraindications, consent signed, vaccine given.  No s/d of reaction.  13:50, patient found by staff, unresponsive, no pulse, no respiration's.  MD notified.  Stated patient expired due to disease and secondary diagnosis.  6/3/08 Death certificate states COD as cardiac arrhythmia R/T atherosclerosis, atrial fibrillation, CHF & cerebrovascular disease.	Y	12/03/2007							N	12/03/2007	12/03/2007	0	Unknown	PUB	PVT	Unknown	No acute - cleared for vaccine	Unknown			1						1	Death; Pulse absent; Respiratory arrest; Unresponsive to stimuli	FLU3~SANOFI PASTEUR~U2509AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0300935	12/26/2007	WV	74.0	74		F	12/17/2007	11/28 - pt. agitated, mental changes. 11/30 - wheezing noted in lungs, anxious, shortness of breath. 12/2 - patient moved to Critical Care unit. 12/28/07 Reviewed partial hospital medical records which reveal patient experienced lower abdominal pain x 1 mo & rectal bleed x 2 wks. Admitted 11/26- Developed cough, wheezing & SOB & dx w/hospital acquired bronchopneumonia.  Tx w/IV antibiotics.  Developed (+) c. difficele.  Later in hospitalization dx w/GBS & intubated.  Developed mild acute pancreatitis & ileus. FINAL DX: Guillain Barre syndrome. 2/11/08 Reviewed hospital medical records.  No D/C summary available. Admitted 11/26/2007-2/2/2008 when transferred to inpatient rehab.  Originally admitted for lower abdominal pain & GI bleed & was to have hemicolectomy.  Received flu shot while hospitalized then developed generalized weakness & respiratory distress. Intubated & transferred to ICU.  LE reflexes absent.  Tx w/IVIG x 2 w/some improvement.  Trach done & weaned from vent. FINAL DX: no d/c summary available but transfer H&P states: debility & Guillian Barre syndrome, recovering; hypertensive cardiovascular disese; recent acute respiratory failure s/p trach & ventilation treatment; c. diff, resolved; hypothyroidism; COPD; & generalized anxiety disorder. Patient admitted in Acute Rehab at medical center for physical and occupational therapy. Patient is still very weak. She needs assistance/supervision with walking, grooming, using bedside commode. 1/20/2010 Left with chronic disability. She needs 24 hour care/assistance. She can walk with walker but is very weak. She needs assitance bathing, cleaning, and grooming. She is on PRN Oxygen.  02/03/2010 Patient admitted in rehab for physical and occupationa therapy.					Y	38	Y		N	11/27/2007	11/28/2007	1	LABS: CT scan revealed rectal/sigmoid lesion.  Urine c/s (+) LABS: EMG/NCS abnormal.  CSF WBC 0, RBC 3, glucose 119 (H), protein 34.7 (N).  CRP 15.4 (H).  Urine & sputum c/s (+).  Stool c.diff tox (+).  Transfused PRBC x 4 for anemia.  Colonscopy w/biopsy abnormal.	PUB	PVT	Synthroid, Lexapro, Altace, Xanax, Seroquel, Miralax, Multivitamins	GI symptoms/gastritis	COPD, anxiety disorder, hypothyroidism, hypertension, GI symptoms PMH: COPD, depression, anxiety, panic disorder, OBC.  HTN, hypothyroidism, chronic hyponatremia. Recent CVA.			1						1	Abdominal pain lower; Agitation; Anaemia; Anxiety; Asthenia; Colectomy; Dyspnoea; Endotracheal intubation; Gastrointestinal haemorrhage; Mental status changes; Occupational therapy; Physical disability; Physiotherapy; Rectosigmoid cancer; Wean from ventilator; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA305BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0300939	12/26/2007	MA	83.0	83		F	12/26/2007	10/26/07 - Patient reports left arm aches awful where flu shot was given 10 days ago.  No home intervention for pain.  No redness, swelling or discharge.  Advised ice and Tylenol as needed.  Seen by M.D. 11/1/07 for persistent pain.				Y					U	10/16/2007	10/16/2007	0		PVT	PVT	Bizabathy, metoprolol, levothyanine, advair, calcium,lisnopril, percecet	None	Anemia, hypothroidism, chronic lung disease, osteoarthritis, colon polyps, h/o pnuemonia, anxiety.			1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2513AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0300941	12/26/2007	MA	60.0	60		F	12/26/2007	On 10/29/07 pt reported to PCP office left arm very sore after receiving flu & pneumonia vaccines 10/25/07.  Was seen in ER at hospital 10/27/07 for symptoms.  Pain improving 10/29/07.				Y					Y	10/25/2007	10/25/2007	0	10/27/07 blood culture negative; WBC 8.3; Hgb 14.0; Hct 40.4	PVT	PVT	Lunesta, Lyrica, Lipitor, Celebrex, meclizine, Vesicare, Effexor, Docusate, fish oil, garlic, aspirin, Ca +D, MVT, vita, metoprolol, cyclobenzeprine, Vicodin, omneprazole	metastatic breast cancer	arthritis, obesity, fibromyalgia, high chol, HTN, GERD, h/o pneumonia, breast cancer with mets, urinary incontinence, Rt lymphedema, sarcoidosis, insomnia, neuropathy, hot flashes, allergy to Amitriptyline, Zithromycin, PCN, sulfa, tetracycline			1						1	Blood culture negative; Haematocrit normal; Haemoglobin normal; Injection site pain; White blood cell count normal	FLU3~SANOFI PASTEUR~U2513AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1229F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0300942	12/26/2007	MA	64.0	64		M	12/26/2007	Severe pain started in right arm the night vaccine was given.  Could not sleep.  Pain described as in agony.  Missed work the following day.  Seen in emergency room 10/27/07 for pain, office visit 10/29/07 for pain and 11/07/07.  Interventions included ice to affected area.  Tylenol, Motrin, Percocet and Vicodin for pain.  None helped.				Y					U	10/25/2007	10/25/2007	0	10/27/07 - blood culture - negative, WBC - 12.1, HgB - 13.2, HcT - 39.1.  Shoulder x-ray operative change and rotator intervention.	PVT	UNK	Lipitor, Aspirin, Lisinopril, Pravix, Metaprolol, Nexium, Nitro, Fish Oil, Vitamin C, MVI, Calcium, Garlic	Left shoulder strain	Angina, obesity, heart disease, HTN, hyperiglycemia, basal cell carcinoma			1						1	Blood culture negative; Haematocrit normal; Haemoglobin normal; Pain in extremity; White blood cell count; X-ray limb abnormal	FLU3~SANOFI PASTEUR~U2513AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1229F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0300943	12/26/2007	MI	16.0	16		F	12/20/2007	No symptoms or problems but client received 2 influenza vaccines, 2 separate arms at same time during vaccination clinic by 2 nurses.  Vaccines were marked correctly but 1 flu vaccine was set up for sibling.  Both nurses grabbed flu shot, gave at same time.									Y	12/20/2007				PUB	PUB	None	None	None			1						1	Incorrect dose administered; Medication error	FLU3~SANOFI PASTEUR~U2523AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB171AA~1~IM~LA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~1063U~1~IM~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2418AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~71206~6~IM~RA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1495U~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0300945	12/26/2007	CA	19.0	19		F	12/17/2007	Injection arm became swollen, red and painful in the upper section of the arm.  Patient went to her physician and the emergency room on 12/13/07.  Discharged with diagnosis:  Local reaction.				Y					Y	12/11/2007	12/13/2007	2	None	PVT	PVT	Thyroid medicine	None	Allergic to Sulfa and Low thyroid			1						1	Erythema; Local reaction; Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79489~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB288AA~2~UN~RA~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0300947	12/26/2007	MN	64.0	64		F	12/16/2007	Ibuprofen for 6 days in diminishing amounts. Very Sore muscles in shoulders and arms then in back, then legs. Within one week I was limping and unable to bear weight on left leg upon waking. Recovery 1 month									Y	11/07/2007	11/08/2007	1	none.	UNK	UNK	none	none	Codeine and otherwise chemical, V environmental allergies only.	I never had flu vaccine before.~ ()~~0.00~In Patient		1						1	Back pain; Myalgia; Pain in extremity; Weight bearing difficulty	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ASLLA064AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0300948	12/26/2007	CA	0.5	0	.5	F		Facial and eye swelling, treated with antihistamines.				Y					Y	12/13/2006	12/13/2006	0	None	PVT	PVT	None	None	None			1						1	Eye swelling; Medication error; Swelling face	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B056DA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2456FA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~0986U~1~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0300951	12/26/2007	GA	52.0	52		F	12/19/2007	Local reaction to vaccine with development of hives requiring ER visit.				Y					Y	11/01/2007	11/04/2007	3		PVT	OTH	Ativan, Herceptin, Lexapro, Relafen, Replens, Wellbutrin Sr		NKDA, HTN, osteopenia, depression, breast cancer			1						1	Local reaction; Urticaria	FLU3~SANOFI PASTEUR~U2446AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1132U~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0300953	12/26/2007	PA	64.0	64		F	10/23/2007	Patient called, return call to her at 1:30pm.  No fever.  c/o bright red streak from injection site & near armpit.  Advice-take temp, 2 Tylenol & cool compress.  I returned phone call at 3:45pm, no change.  Patient did talk to her MD office, same advice given.  She was told to call me if no improvement.									U	10/17/2007	10/17/2007	0		PUB	UNK		None				1						1	Injection site erythema; Injection site streaking	FLU3~SANOFI PASTEUR~V21151AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0061U~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0300956	12/26/2007	MI	20.0	20		F		Shortly after injection, had flu like symptoms - chills, aching, fever 103 later that evening.  This morning, feels well - temperature 99.7 - area of redness at injection site 7cm x 5cm - tender to the touch.									Y	12/18/2007	12/18/2007	0	None	PVT	PVT	BCP - Flurocet	None	None			1						1	Chills; Influenza like illness; Injection site erythema; Injection site pain; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2526AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300957	12/26/2007	PA	73.0	73		F	10/26/2007	1/4 round pimple like rash at injection site occurring on 10/17/07 no pain, no fever, no drainage, no swelling.  Pt. applied antibiotic cr. & took Benadryl 25 mg at  on 10/24.  Saw Dr. on 10/26/07, Dr. reported the rash was prob from the flu vaccine.									Y	10/15/2007	10/17/2007	2		UNK	UNK	Tramadol		per pt.-arthritis			1						1	Injection site rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80061~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0300958	12/26/2007	NC	55.0	55		F	12/20/2007	Left arm pain radiating to fingers, especially painful when raising arm over head.  Onset in 48 hours, after injections; continues to persist 1 month later.  Physical exam 1 week later - no redness, no swelling at site.  Temperature 98.4.  Patient declined f/u visit at this time (reports continued symptoms by phone).  Has been applying moist heat, massage and gentle exercise.  Still has left arm pain. Telephone follow-up to patient.  She reports pain in Left arm was completely resolved by mid-January, 2008.				Y					N	11/16/2007	11/18/2007	2	Patient advised to return for WBC and ultrasound.	PVT	PVT	Prozac, Nexium, Clonazepan, Ambien CR	None	Depression/grief due to recent death of husband to cancer.			1						1	Pain in extremity; Ultrasound abdomen; Ultrasound scan; White blood cell count	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80063~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~MERCK & CO. INC.~1377U~1~IM~LA~HEP A (VAQTA)~1|TDAP~SANOFI PASTEUR~C2863AA~UNK~IM~LA~TDAP (ADACEL)~1|YF~SANOFI PASTEUR~UF102AA~1~SC~RA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0300959	12/26/2007	WI	0.5	0	.5	F	12/13/2007	Was given 1/2 dose of Fluzone at 5 1/2 months vs 6 months.									Y	11/14/2007				OTH	OTH	None	None	None			1						1	Inappropriate schedule of drug administration; Incorrect dose administered	FLU3~SANOFI PASTEUR~U2493AA~1~UN~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300960	12/26/2007	CO	1.4	1	.4	M	12/17/2007	Febrile seizure.				Y					Y	12/14/2007	12/14/2007	0	CBC with Ciff, CRPHS, Influenza A&B antigen	PVT	PVT		Cough	None			1						1	Febrile convulsion; Full blood count; Influenza	DTAP~SANOFI PASTEUR~C2765AA~4~IM~~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2525AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C45888~4~IM~~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0300965	12/26/2007	TX	2.0	2	.6	F	12/26/2007	A cold started one day after the vaccine was given. It turned into a fever and so forth. It has been a roller coaster ride since then. She has been falling sick a number of times after that.(Fevers/ear infections probably due to school) But associated with these fevers are cough and cold. The cough stays on for a long time and does not go away. First time it stayed for 7-10 days and now it has been almost a week. Paediatrician now put her on steroids for lungs(symbicort,xopenex) and today diagnosed it as asthma. My daughter never had asthma before and she never got this cough before even in the last winter. The flumist was given on oct 8 but at that time my daughter was not diagnosed with asthma. One of the warnings on flumist handout is to avoid giving it to kids with asthma. My daughter also has eczema and food allergies. I regret getting flumist now with all these warnings abt asthma and 24 months(she was 5 months over but the warning says increased risk of wheezing for kids <24 mo) and feel that this coughing might be due to that.									U	10/08/2007	10/09/2007	1	chest x-ray showd mild reactive airways changes.	UNK	UNK		none	food allergies, eczema			1						1	Asthma; Chest X-ray abnormal; Cough; Ear infection; Nasopharyngitis; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0300971	12/26/2007	CA	20.0	20		M	12/13/2007	IM influenza vaccine was mistaken for Flumist and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None	None			1						1	Incorrect route of drug administration; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLVA316BA~1~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0300972	12/26/2007	PA	12.0	12		F	12/20/2007	At site of immunization (R deltoid), 5 cm area induration, no erythema.  (Examined 12/19/2007, reaction began evening of immunization 12/17/07).										12/17/2007	12/17/2007	0		PVT	UNK		None	Allergic to Codeine			1						1	Injection site induration	FLU3~SANOFI PASTEUR~U2531AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1522U~3~IM~RA~HPV (GARDASIL)~1	USA		Influenza
0300976	12/26/2007	NY	1.5	1	.5	F	12/14/2007	5 cm area of erythema and induration left upper arm.  Warm but no apparent tenderness.									U	12/12/2007	12/13/2007	1		PVT	UNK						1						1	Injection site erythema; Injection site induration; Injection site warmth	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC1443044~4~~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2532AA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~20813~3~~RA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0300984	12/26/2007	VA	1.3	1	.3	M	12/17/2007	Received Varivax vaccine on 12/4/07.  Now has several chicken-pox looking bumps on leg 12/15/07.									Y	12/04/2007	12/15/2007	11		PVT	PVT		none	none			1						1	Rash vesicular	FLU3~SANOFI PASTEUR~UT2460AA~3~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0426U~1~IM~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0300986	12/26/2007	CA	37.0	37		F	11/30/2007	Pt. received Influenza vaccine L deltoid 11/6/07 and immediately had pain at injection site and L shoulder pain.									U	11/06/2007	11/06/2007	0		PVT	PVT		None				1						1	Immediate post-injection reaction; Injection site pain; Musculoskeletal pain	FLU3~SANOFI PASTEUR~U2515AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0300988	12/26/2007	IL	3.0			M	11/26/2007	Complaint of cramping in leg But I believe he woke suddenly, started crying, complained of leg cramp, then forgot which leg he had complained about									Y	10/24/2003	10/24/2003	0		PVT	UNK						1						1	Crying; Muscle spasms	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0300991	12/26/2007	PA	5.0	5		F	12/17/2007	Swelling of R upper arm extending deltoid area to elbow.				Y					Y	12/12/2007	12/14/2007	2	none	PVT	PVT		none				1						1	Injection site swelling	FLU3~SANOFI PASTEUR~U24618A~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1084U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0300992	12/26/2007	CA	4.0	4		F	12/14/2007	Left deltoid raised, red, hot to touch.  Approx. 7 cm x 10 cm size bump.									N	12/11/2007	12/13/2007	2		OTH	PUB	Benadryl, Cortaid	None	None			1						1	Injection site erythema; Injection site swelling; Injection site warmth	DTAP~SANOFI PASTEUR~C2607AA~5~UN~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2498AA~2~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z08732~4~UN~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1217F~2~UN~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1005U~3~UN~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0300995	12/26/2007	DC	1.1	1	.1	M	12/20/2007	Patient developed rash over body and face next morning following immunizations.  Pt returned to clinic on 12/19/07, seen by Dr.  MdI inhaler (Albuterol) prn for episode of wheezing.  F/u call placed by nurse, mother stated pt is fine and rash has improved.  Denied pt to have SOB or difficulty breathing.				Y					Y	12/17/2007	12/18/2007	1		PUB	UNK	Albuterol inhaler in event of wheezing, PPD test, C2671AA, ID, 0 previous doses	none	none			1						1	Rash; Rash generalised; Wheezing	FLU3~SANOFI PASTEUR~U2435AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB206CA~1~IM~UN~HEP A (HAVRIX)~1|MMRV~MERCK & CO. INC.~0775U~1~SC~UN~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0300998	12/26/2007		42.0	42		M	12/05/2007	Pain in left side of head, hard to swallow, fever (99.0-101.9), chills, night sweats, lymphadenopathy, facial pain (left temple), L EOC erythemic, increased neutrophils.				Y					Y	11/30/2007	12/03/2007	3	CBC, RPR, UA drawn 04Dec07.  No FluMist shot only.	OTH	MIL	None	None	None			1						1	Chills; Dysphagia; Erythema; Facial pain; Full blood count; Headache; Lymphadenopathy; Neutrophil count increased; Night sweats; Pyrexia; Syphilis test; Urine analysis	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0301002	12/26/2007	WI	51.0	51		F	12/19/2007	Rash										11/05/2007	11/07/2007	2		PVT	PVT			Asthma			1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0301006	12/26/2007	OK	4.0	4		M	12/14/2007	Had flu shot on 11-7-07.  Within 24 hours rash developed on palms of hands and then scattered rash developed.  Child given Benadryl & rash resolved.									Y	11/07/2007	11/07/2007	0		PUB	PUB		None	None			1						1	Rash generalised	FLU3~SANOFI PASTEUR~u2508aa~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0301010	12/26/2007	CO	44.0	44		F	12/18/2007	Pt has pain in her left shoulder, mostly at night and when she lifts her arm.									U	11/27/2007	11/28/2007	1	No tests performed.	OTH	PVT		None	None			1						1	Injected limb mobility decreased; Musculoskeletal pain	FLU3~SANOFI PASTEUR~U2515AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0301012	12/26/2007	OK	47.0	47		M		Received flu shot on 12-13-07.  On 12-14-07 developed a rash and/or whelps scattered over body.									U	12/13/2007	12/14/2007	1		PUB	PUB		None				1						1	Rash generalised; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80956~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0301014	12/26/2007	IA	50.0	50		F	12/14/2007	Effusion L knee joint & lesser degree R.									N	11/26/2007	11/27/2007	1	None yet	OTH	OTH	Levaquin, Clonazepam, Abilify, trazodone, Lamictal, alprazolam, Sertraline	Treating sinusitis	Bipolar, fibromyalgia, ADD, deg. joint disease			1						1	Joint effusion	FLU3~SANOFI PASTEUR~U2478FA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0865U~UNK~UN~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0301016	12/26/2007	IN	3.0	3		F	12/20/2007	Pt had swelling the size of quarter or a little bigger.  Injection site had some fever & was sore to touch and was increasing in size.  This shot was given on 12/10/07 & child was seen for swelling on 12/12/07.  Pt was treated with Amoxicillin for cellulitis.				Y					U	12/10/2007	12/12/2007	2	None	PVT	PVT	None	None	None			1						1	Cellulitis; Injection site pain; Injection site warmth; Swelling	FLU3~SANOFI PASTEUR~U2530AA~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0301020	12/26/2007	MI	68.0	68		F	12/11/2007	Pt began experiencing tingling and tenderness in her extremities similar to a bruise or sunburn.  It would come & go & seemed to travel around her body.  On 12/7/07 her feet began to swell.  Symptoms have improved as of 12/11/07.  Dr. thought possibly viral infection.				Y					U	11/20/2007	11/25/2007	5	Blood culture negative for bacteria per patient.	UNK	UNK	None		None			1						1	Blood culture negative; Oedema peripheral; Paraesthesia; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA319BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0301023	12/26/2007	WY	1.2	1	.2	F	12/18/2007	Pt developed 45 mm indurated red area to thigh where vaccines were given.  Area L thigh still present although faded to brown in color.									Y	11/29/2007	11/29/2007	0		PVT	PUB						1						1	Injection site discolouration; Injection site erythema; Injection site induration	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B129AA~UNK~UN~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2459KA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0435U~1~UN~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0606F~1~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08700B~1~UN~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0301024	12/26/2007	MA				U		Within hours of receiving flu & pneumonia vax in the same arm, this case experienced; chills/sweats, weakness & fever 101.8-sx that lasted-6 days.  Left arm weakness with swelling & limited movement 3 days.  Seen by PCP, round of Cephalexin given.  BOH notified by case 12/10/07, case feeling better.									Y	12/03/2007	12/04/2007	1	None	PUB	PUB		None	None	none~ ()~~0.00~In Patient		1						1	Asthenia; Chills; Hyperhidrosis; Injected limb mobility decreased; Injection site movement impairment; Injection site swelling; Oedema peripheral; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA050AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0964U~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0301025	12/26/2007	CA	22.0	22		M	12/20/2007	Patient noticed bump similar to his smallpox vaccination site about 2 cm from the vaccination site.									N	12/10/2007	12/19/2007	9		MIL	MIL	None	No	None			1						1	Nodule	ANTH~EMERGENT BIOSOLUTIONS~FAV158~UNK~SC~LA~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500488P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~PFIZER\WYETH~4020076~UNK~ID~LA~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~A02212~UNK~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0301026	12/26/2007	MA	1.5	1	.5	M	12/19/2007	In for well visit 12/5/07, due for DTaP, IVP and flu.  Inadvertently given 2 flu vaccines .25 ml instead of 1 flu .25 ml and IPV.									Y	12/05/2007			none	PVT	PUB	vitamins with fluoride	no	no			1						1	Incorrect dose administered	DTAP~SANOFI PASTEUR~U2542AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2459KA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0301028	12/26/2007	CA	41.0	41		M	12/13/2007	IM influenza vaccine was mistaken for FluMist and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.										12/09/2007			none	MIL	MIL		None known	None known			1						1	Drug administered at inappropriate site	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301029	12/26/2007	TX	24.0	24		M	12/13/2007	IM influenza vaccine was mistaken for FluMist and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None known	None known			1						1	Drug administered at inappropriate site	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301030	12/26/2007	CA	35.0	35		M	12/13/2007	IM influenza vaccine was mistaken for 'FluMist' and administered to the nasal passage as a liquid. Once mistake was determined, it was given IM.										12/09/2007			None	MIL	MIL		None known	None known			1						1	Incorrect route of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301031	12/26/2007	CA	20.0	20		F	12/13/2007	IM influenza vaccine was mistaken for FluMist and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None known	None known			1						1	Drug administered at inappropriate site	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301032	12/26/2007	CA	28.0			M	12/13/2007	IM influenza vaccine was mistaken for FluMist and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None known	None known			1						1	Drug administered at inappropriate site	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301033	12/26/2007	CA	28.0			F	12/13/2007	IM influenza, vaccine was mistaken for Flu Mist and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None	None			1						1	Incorrect route of drug administration; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLVA316BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB443AA~3~IM~UN~HEP B (ENGERIX-B)~1	USA		Influenza
0301034	12/26/2007	CA	26.0	26		M	12/13/2007	IM influenza vaccine was mistaken for FluMist and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None known	None known			1						1	Drug administered at inappropriate site	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301035	12/26/2007	CA	40.0	40		M	12/13/2007	IM influenza vaccine was mistaken for 'FluMist' and administered to the nasal passage as a liquid. Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None known	None known			1						1	Incorrect route of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301036	12/26/2007	CA	33.0	33		M	12/13/2007	IM influenza vaccine was mistaken for Flu Mist and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None	None			1						1	Incorrect route of drug administration; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301037	12/26/2007	CA	25.0	25		M	12/13/2007	IM influenza vaccine was mistaken for FluMist and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None known	None known			1						1	Incorrect route of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301038	12/26/2007	CA	42.0	42		M	12/13/2007	IM influenza vaccine was mistaken for FluMist and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None known	None known			1						1	Incorrect route of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301039	12/26/2007	WA	28.0	28		M	12/13/2007	IM influenza vaccine was mistaken for FluMist and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None known	None known			1						1	Incorrect route of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301040	12/26/2007	CA	34.0	34		M	12/13/2007	IM influenza vaccine was mistaken for 'FluMist' and administered to the nasal passage as a liquid. Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None known	None known			1						1	Incorrect route of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB443AA~3~IM~UN~HEP B (ENGERIX-B)~1	USA		Influenza
0301041	12/26/2007	CA	35.0	35		M	12/13/2007	IM influenza vaccine was mistaken for Flu Mist and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None	None			1						1	Incorrect route of drug administration; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301042	12/26/2007	CA	26.0	26		M	12/13/2007	IM influenza vaccine was mistaken for Flu Mist and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None	None			1						1	Incorrect route of drug administration; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~2~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301043	12/26/2007	NM	24.0	24		M	12/13/2007	IM influenza vaccine was mistaken for Flu Mist and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None	None			1						1	Incorrect route of drug administration; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301044	12/26/2007	CA	26.0	26		M	12/13/2007	IM influenza vaccine was mistaken for Flu Mist and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None	None			1						1	Incorrect route of drug administration; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301045	12/26/2007	CA	24.0	24		M	12/13/2007	IM influenza vaccine was mistaken for Flu Mist and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None	None			1						1	Incorrect route of drug administration; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB443AA~3~IM~UN~HEP B (ENGERIX-B)~1	USA		Influenza
0301046	12/26/2007	CA	25.0	25		M	12/13/2007	IM influenza vaccine was mistaken for Flu Mist and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None	None			1						1	Incorrect route of drug administration; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301047	12/26/2007	FL	46.0	46		M	12/13/2007	IM influenza vaccine was mistaken for Flu Mist and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None	None			1						1	Incorrect route of drug administration; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|TD~SANOFI PASTEUR~U19270A~1~IM~UN~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0301048	12/26/2007	CA	41.0	41		M	12/13/2007	IM influenza vaccine was mistaken for 'FluMist' and administered to the nasal passage as a liquid. Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None known	None known			1						1	Incorrect route of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301049	12/26/2007	CA	44.0	44		M	12/13/2007	IM influenza vaccine was mistaken for Flu Mist and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None	None			1						1	Incorrect route of drug administration; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301050	12/26/2007	NV	42.0	42		M	12/13/2007	IM influenza vaccine was mistaken for Flu Mist and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None	None			1						1	Incorrect route of drug administration; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301051	12/26/2007	CA	29.0	29		M	12/13/2007	IM influenza vaccine was mistaken for 'FluMist' and administered to the nasal passage as a liquid. Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None known	None known			1						1	Incorrect route of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301052	12/26/2007	CA	23.0	23		M	12/13/2007	IM influenza vaccine was mistaken for Flu Mist and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None	None			1						1	Incorrect route of drug administration; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301053	12/26/2007	CA	36.0	36		M	12/13/2007	IM influenza vaccine was mistaken for Flu Mist and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None	None			1						1	Incorrect route of drug administration; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB433AA~1~IM~~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB139AA~1~IM~~HEP A (HAVRIX)~1|TD~SANOFI PASTEUR~U19270A~1~IM~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0301055	12/26/2007	MA	4.0	4		M	12/29/2007	Vaccine at 0900 a.m.  At night, fever from 102 to 104 degrees F.  Developed cough, wheeze, respiration distress.  Sent by 911 to emergency department for wheezing.				Y					Y	11/14/2007	11/14/2007	0	None	PVT	PUB	None	None	None			1						1	Cough; Pyrexia; Respiration abnormal; Wheezing	FLU3~SANOFI PASTEUR~U2437AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0324817	12/26/2007	AZ	78.0	78		F	12/19/2007	Chills, achy, swollen arm where injection was put. Arm sore for about a week.									Y	11/26/2007	11/26/2007	0		PVT	UNK	Atacand,Levothyroxine, Fluoxetine, Taxa, Neurontin	No acute illness	Allergy to PCN, sulfa, iodine, bentyl, Bactrim, Hydrocodone. Medical conditions: HTN, Diverticulitis, Neuropathy			1						1	Chills; Injection site pain; Injection site swelling; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78476~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1035F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0301083	12/27/2007	NY	46.0	46		F	12/27/2007	Nickle size muscle wasting left lower deltoid. Patient noticed 11/13/07. No pain or weakness. Treatment - Physical Therapy. 10/23/07 TDap and 11/6/07 Flu vaccine (Both left deltoid)									U	10/23/2007	11/13/2007	21		PUB	PUB	none	none	Thyroid nodule			1						1	Muscle atrophy	DTAP~SANOFI PASTEUR~Adacel C2842AA~1~IM~LA~DTAP (DAPTACEL)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78991~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0301085	12/27/2007		23.0	23		M	12/27/2007	We received on 13 DEC 2007 the following information from a health care professional: A 23-year-old male patient, born on 29 AUG 1984, was vaccinated i.m. with Fluvirin 2006/2007 (expired on 30 JUN 2006), batch no. 69690, on 10 DEC 2007.  On 12 DEC 2007 the patient developed an adverse vaccination reaction (not further specified) and was hospitalized.  The patient was still hospitalized at time of reporting.  Further information was requested.  Company assessment: seriousness criterion: hospitalization.  Causality: insufficient data.  The amount of data is insufficient to assess causality of this case.  Expectedness assessment: Administration of expired vaccine is not expected.  No change in benefit-risk-ratio.  No measures necessary.  Ref no.: NA07-007052.					Y	0			U	12/10/2007	12/12/2007	2		OTH	OTH		Unknown			MA20071674	1						1	Vaccination complication	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~69690~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0301089	12/27/2007	NY	0.5	0	.5	M	12/26/2007	Information has been received from a consumer concerning her 7 month old son with a history of jaundice at birth and no known drug reactions/allergies who in November 2007 (exact date not reported), was vaccinated (route and site not reported) with a PedvaxHIB (manufacturer unknown). Mother thought the vaccine her son received was recalled but was unsure if he received PedvaxHIB (lot# not reported). The mother could not specify which vaccine her son had received. Concomitant therapy included acetaminophen (TYLENOL). In November 2007 (exact date not reported), post vaccination, the patient developed a fever, vomiting and cough. The patient was admitted into the hospital 3 days after. It was concluded that the patient had bronchitis. The mother reported that the patient was still vomiting but thought it might be from teething and that he still had a cough. The mother also reported that the patient had loose stool. The patient did receive unspecified medical attention. No diagnostic labs tests were performed. Additional information has been requested. 6/2/08-records received for DOS 11/19-11/20/07-DC DX: bronchiolitis. Presented to ED with C/O cough and cough times 2 days, trouble breathing since yesterday worse today. Poor feeding all day. Lungs diminished breath sounds, wheezes upon inspiration upon expiration. Respirations rapid labored intercostal retractions accessory muscle use. Body temperature increased.				Y	Y	1	Y		N	11/16/2007	11/17/2007	1	None 6/2/08-records received-Chest x-ray no acute lung pathology or masses.	OTH	OTH	Tylenol		Jaundice		WAES0712USA04677	1						1	Cough; Diarrhoea; Pyrexia; Vomiting	DTAP~SMITHKLINE BEECHAM~ac21b057ap~3~~~DTAP (INFANRIX)~1|FLUX~UNKNOWN MANUFACTURER~0f2456a~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~MERCK & CO. INC.~0677U~3~UN~UN~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~b54015d~3~~~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0301099	12/27/2007	TX	48.0	48		M	12/27/2007	Flu shot given on 11/8/07. Patient reports 1)onset of bilateral eye discomfort on 11/17/07, 2) decreased bilateral eyesight starting 11/17/07 and sight very reduced by 12/4/07 (I could only see shapes). Patient reports that he was seen by othalmologist who informed him that he has optic neuropathy that was triggered by the flu shot. Patient reports that Dr. has predicted a full recovery with an estimated time of midFebruary 2008. No medications given 1/2/08-records received for DOS 12/5/07-DX: bilateral disc edema. 12/19/07-gradually improving. Tenderness resolved.									Y	11/08/2007	11/17/2007	9	N/A\1/2/08-records received-Rheumatoid factor C3 158.	UNK	UNK	Long term medication:         Diavan HCT160/12.5 QD PO         Potassium Chloride 20meq BID PO	denies	NKMA, HTN			1						1	Eye pain; Optic neuritis; Visual acuity reduced	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA312AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301101	12/27/2007	CA	42.0	42		F	12/27/2007	Rash on Left arm 24 hours after injection, Left arm pain with pain radiating to joints throughout body approximately 72 hours after injection.  Continues with Left arm pain									Y	10/30/2007	10/31/2007	1	None	PVT	PVT	Effexor XR, Soma, Vicodin, Ultram, Iron Injections, Multi-vitamins, Calcium, Vitamin D, Vitamin A	None	Hx. gastric bypass, hx. Hepatitis C,  Allergic to sulfa medications			1						1	Arthralgia; Pain in extremity; Rash	FLU3~SANOFI PASTEUR~42498AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0301103	12/27/2007	OH	22.0	22		M	12/27/2007	PT HAD NO PREVIOUS HISTORY OF INFLUENZA VACCINE. HE STATED THE HE NEVER RECEIVED FLU SHOT BEFORE, EVER. IMMEDIATE ORAL SWELLING, SNEEZING, UNLABORED RESPIRATION, ALERT AND ORIENTED X 3. SEEN IN ER AND WAS DISCHARGED WITH PREDNISONE, CLARITIN AND BENADRYL.									Y	12/21/2007	12/21/2007	0		MIL	MIL	NONE	NONE.	NONE			1						1	Oedema mouth; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0301126	12/27/2007	RI	35.0	35		M	11/20/2007	Swollen left arm with marked edema and requirement of opening arm surgically. 1/10/08-ER records received for DOS 11/17/07-DX: left arm cellulitis. Started with fever night before, arm at injection site painful and difficult to move. Blood culture no growth. 3/17/08-records received for DOS 11/17-11/23/07-DC DX: Cellulitis of upper arm and forearm. Upper extremity infection following vaccination as an outpatient. Onychomycosis of nail and foot. Presented to ED with swelling and pain of arm. Swelling continued to increase area dusky in color. Rash medial to injection site. Exploratory surgery of the site, incision and drainage.					Y	6			Y	11/15/2007	11/16/2007	1	Surgery 3/17/08-records received-CT scan of arm showed inflammatory changes of anterolateral compartment of left upper arm. Cultures negative. WBC increased. Glucose increased.	PVT	UNK			Diabetes mellitus, HTN, hyperlipidemia 3/17/08-records received-PMH: Poorly controlled diabetes mellitus type 2. Hyperlipidemia. Unspecified anemia. Tobacco use disorder.			1						1	Oedema peripheral; Surgery	FLUX~UNKNOWN MANUFACTURER~0859~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~0858U~UNK~UN~LA~PNEUMO (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0301131	12/27/2007	AR	1.3	1	.3	M	12/26/2007	Spiked high fever, and had febrile seizure the night of the day the vaccines were administered.  Fever resolved by the next day.				Y					Y	12/21/2007	12/21/2007	0		PVT	PUB		None	None			1						1	Febrile convulsion; Pyrexia	DTAP~SANOFI PASTEUR~U2156AA~1~~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT2459BA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0260U~4~~LL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B54D13C~4~~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0301132	12/27/2007	NJ	1.1	1	.1	F	12/27/2007	A circular erythamatous, swollen area about 1 inch x 1 inch in size on left lateral thigh.									U	12/17/2007	12/24/2007	7		PVT	PUB						1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~42458AA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~15834~UNK~UN~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0301133	12/27/2007	IN	1.0	1	.0	F	12/27/2007	erythematous plague on (L) upper thigh at vaccine site 1.2 x 1.2 cm noted 1-2 days after shot and still persists 2 wks after shot-seems less thickened now									Y	12/12/2007	12/27/2007	15	None	PUB	PUB	Tylenol, hydrocortisone cream	actopic dermatitis	None			1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U2502AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAAVB217AA~1~IM~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0425U~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0365U~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0301136	12/27/2007	SC	38.0	38		F	12/20/2007	Itching at site, generalized itchy, swelling in throat, bronchospasm.									Y	12/19/2007	12/19/2007	0	None	PVT	PVT						1						1	Bronchospasm; Injection site pruritus; Pharyngeal oedema; Pruritus generalised	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA051AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0888F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0301137	12/27/2007	NV	4.0	4		F	12/20/2007	first dose given 11/6/07, 11/7/07 Rash on back Dx Allergic vs viral, Sent home from school. 11/29/07 Sent home from school Macules on back off and on. 12/7/07 Pt came for 2nd flu-Nurse noted rash-had provider see pt gave ok for #4. 12/19/07 Rash resolving-Paraflu vaccine									Y	11/06/2007	11/07/2007	1		PVT	PUB		No				1						1	Hypersensitivity; Rash macular	FLUX~UNKNOWN MANUFACTURER~UT2456EA~2~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0301140	12/27/2007	TX	47.0	47		F	11/23/2007	Clammy skin, fainting spells lasting 10 to 20 seconds.  Had patient to smell ammonium salts.									Y	11/23/2007	11/23/2007	0	Blood pressure within normal limits	OTH	PVT	Skelaxin	None				1						1	Blood pressure normal; Cold sweat; Syncope	FLU3~SANOFI PASTEUR~U2445AA~1~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298957	12/28/2007	SC	82.0	82		F	12/21/2007	Information has been received from a pharmacist concerning a female, with no medical history and no known drug allergies, who on 09-NOV-2007 was vaccinated with a 0.65 ml subcutaneous dose of zoster vaccine live (Oka/Merck) (Lot# 658084/0888U). There was no concomitant medication. Subsequently the patient developed shingles. The patient was seen by a physician and was prescribed FAMVIR. The patient's shingles persisted. No product quality complaint was involved. Additional information has been requested.				Y					N	11/09/2007			Unknown	OTH	OTH	None		None		WAES0711USA03445	1						2	Herpes zoster; Herpes zoster	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~0888U~UNK~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1|VARZOS~MERCK & CO. INC.~0888U~UNK~SC~UN~ZOSTER LIVE (ZOSTAVAX)~2	USA	Emergency room visit	Influenza
0301147	12/28/2007	AZ	56.0	56		F	12/28/2007	Patient recieve both pneumo and flu vaccine in same arm.  Next day patient had red, hot, swollen back of arm, but no redness at injection site.  Patient went to instacare and was prescribed doxycycline and zyrtec and recieved an unknown shot and was feeling better in two days.									Y	11/27/2007	11/28/2007	1	N/A	UNK	UNK		no				1						1	Erythema; Oedema peripheral; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA282DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0038U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0301151	12/28/2007	TN	67.0	67		F	12/28/2007	I had the flu vaccine and I had no soreness at the injection site, but the next day between the injection site and my elbow, I experienced a rash and extreme itching.  It covered an area about 3 inches in diameter.  It has continued to itch and sometimes sting in that area.  The skin in that area is hard and dry. I also had a headache the next morning and have continued to have off and on for the past two months.  I have not felt well since the injection. I have had the flu vaccine before with no adverse effects.  I feel like it was a preservative or something that the vaccine was mixed in.  I have allergies to sulfur and sulfur derivatives (even the additives to food) and penicillin.  I am allergic to shrimp.  They cause me to break out in hives.									N	10/18/2007	10/19/2007	1	none	PUB	UNK	none	none	allergic to sulfur and sulfur derivatives, penicillin, shrimp			1						1	Dry skin; Headache; Pain; Pruritus; Rash; Skin induration; Skin reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0301163	12/28/2007	OH	1.1	1	.1	M	12/28/2007	Child has Dravet's Syndrome. Physician provided script requesting child receive his immunizations, except Dtap. He is to receive Dt instead. He has history of seizures, almost monthly. Had been seizure free since 9-25-07. Mom reported on 11/21/07 that child had a total of 7 seizures the evening after his immunizations. Mom states he didn't have a fever until the following evening, but started seizing.. was taken by squad to hospital and intubated. He spent 2 days in the hospital and was released. 4/7/08-records received for DOS 11/15/07 and 12/22/07-Short stay for increased seizure activity most likely due to AFI.  Presented to ED with 24 hour history of acute febrile illness.				Y	Y	3			Y	11/14/2007	11/15/2007	1	4/7/08-records received-WBC 13,000. 12/13/07-EEG mild diffuse cerebral dysfunction and background slowing.	UNK	UNK	Keppra, Depakene	no acute illness	Dravet's Syndrome4/7/08-records received-PMH: Dravet's syndrome. Diagnosed in infancy with myoclonic epilepsy.			1						1	Convulsion; Intubation; Pyrexia	FLU3~SANOFI PASTEUR~UT2477FA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~P0040U~2~IM~RL~HEP B (RECOMBIVAX HB)~1|HIBV~SANOFI PASTEUR~UF144AA~1~IM~LL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~PZ0547-2~1~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~P0651U~1~SC~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~PB47300B~1~IM~RL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0301164	12/28/2007	MI	49.0	49		F	12/28/2007	The day of the vaccine, which was administered in the right deltoid, she developed localized soreness, which has persisted for the past 2 months.  The vaccine was given on 10/28/07.  She still has pain and some weakness of the proximal musculature of the right upper extremity.  Worse at night and in the morning.									N	10/28/2007	10/28/2007	0	I am going to obtain lab work and an x-ray	UNK	PVT	lexapro	none	azithromycin, bactrim, darvocet			1						1	Muscular weakness; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0301169	12/28/2007	OH	12.0	12		M	12/28/2007	dizziness,nausea, elevated blood pressure in the 24 hours after the vaccine was given									Y	11/29/2007	11/29/2007	0	none	PVT	PVT	NONE	NON	ASTHMA, ENVIRONMENTAL ALLERGIES			1						1	Blood pressure increased; Dizziness; Nausea	FLU3~SANOFI PASTEUR~U2507AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0301170	12/28/2007	CA	86.0	86		F	12/28/2007	pt reports he had swelling and pain in the left arm from the shoulder to the elbow within hours of the vaccines.  he came in within a half hour of talking him on the phone after his daughter called me.  on examination he has cellulitis which is treated with oral keflex as recommended by my medical supervisor.									Y	12/27/2007	12/27/2007	0		UNK	PVT	coumadin and a blood pressure and heart medication which he cannot recall the names of	none.  the patient had recently returned from travelling to Nepal.  He took malaria prophylaxis for a very short time during his trip.	atrial fibrillation			1						1	Cellulitis; Oedema peripheral; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA323AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0964U~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0301176	12/28/2007	VA	46.0	46		F	12/28/2007	This case was reported by a consumer, who is also a pharmacist and described the occurrence of pain in a 46-year-old female subject who was vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject thought the vaccine was manufactured by GlaxoSmithKline. On 5 October 2007 at 14:00, the subject received unspecified dose of Influenza vaccine (.5 ml, unknown, left arm). On 6 October 2007, 1 day after vaccination with Influenza vaccine, the subject experienced pain, which radiated from her shoulder down to her hand. The pain in her hand was intermediate, but the frequency had increased. In November 2007, the subject experienced numbness and tingling in her arm, leg, and lip on left side. The subject reported she had not slept in three days. The subject considered the events jeopardizing and required intervention at the doctor's office. The subject was treated with ibuprofen and aspirin. At the time of reporting, the events were worse.				Y					U	10/05/2007	10/06/2007	1	UNK	PVT	PVT	No concomitant medications.	Unknown	No relevant medical history.  The subject had previously received influenza vaccinations without experiencing adverse events.		A0700650A	1						1	Hypoaesthesia; Hypoaesthesia oral; Insomnia; Musculoskeletal pain; Pain in extremity; Paraesthesia; Paraesthesia oral	FLUX~UNKNOWN MANUFACTURER~ASLLA026AA~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0301181	12/28/2007	CA	60.0	60		F	12/12/2007	Patient received vaccine at 17:00 and felt fine.  She went to radiology for an x-ray and then pharmacy.  45-50 minutes after injection patient had uncontrollable shaking and chills.									Y	12/12/2007	12/12/2007	0	Vitals 130/87, pulse 87, pulse ox 99%, bs 103	PUB	PUB	Benadryl 50mg	None	None		CA070041	1						1	Blood glucose normal; Blood pressure; Chills; Heart rate normal; Oxygen saturation normal; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80435~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0301183	12/28/2007	GA	68.0	68		M	11/06/2007	rapid heart rate (5 days later) 11-3-07, hoarseness (2 days later) 10-31-07, fever (6 days later) 11-4-07, pneumonia (reported to Rx) 12-28-07									Y	10/29/2007	10/31/2007	2	Unknown	OTH	PVT	HCTZ, Hydralazine, Amlodipine	None				1						1	Dysphonia; Heart rate increased; Pneumonia; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA303BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301186	12/28/2007	WI	25.0	25		F	12/10/2007	Patient required 2 injections; 1st injection given with no flu vaccine in syringe; 2nd injection had flu vaccine drawn up - was given.									Y	11/13/2007	11/13/2007	0		OTH	UNK						1						1	Medication error; Wrong technique in drug usage process	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81111~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0301187	12/28/2007	WI	18.0	18		F	11/14/2007	None stated										11/14/2007	11/14/2007	0		OTH	UNK			Diabetic			1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81111~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0301188	12/28/2007	WI	58.0	58		F	12/10/2007	Flu shot given (L) arm shortly afterwards, Pt c/o pain radiating down her (L) arm into hand. After she made a fist pain was better. Instructed to use ice pack and use ibuprofen.									Y	11/14/2007	11/14/2007	0		UNK	UNK						1						1	Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81111~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0301191	12/28/2007	OK	0.8	0	.8	M	12/28/2007	Temp 102, fussy, crying, drowsy, difficult breathing, heart rate fast. Nurse used a large amount of vaccine, did not recommend child return for second dose of flu vaccine.									U	12/27/2007	12/27/2007	0		PVT	UNK		No	None			1						1	Body temperature increased; Crying; Dyspnoea; Heart rate increased; Incorrect dose administered; Irritability; Somnolence	FLUX~UNKNOWN MANUFACTURER~UT2456AA~1~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0301192	12/28/2007	CA	26.0			F	12/28/2007	Patient has hypopigmentation in the area of bandaid which covered injection site.													Dermatology consult	PVT	PVT	None	None	None			1						1	Injection site discolouration	FLU3~SANOFI PASTEUR~U2443AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB413AA~3~IM~UN~HEP B (ENGERIX-B)~1	USA		Influenza
0301199	12/28/2007	NE	37.0	37		F	11/18/2007	Within 1 hour, felt itchy all over.				Y					U	11/01/2006	11/01/2006	0		OTH	OTH	Unknown	Unknown	Unknown			1						1	Pruritus generalised	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0301200	12/28/2007	GA	47.0	47		M	12/11/2007	Received flu vaccine on 12/04/2007.  Has never had a flu vaccine in the past.  Awoke this morning with erythema to bilateral elbows and knees.  Affected areas also tender to touch, and itchy.  No limits to ROM.  Vital signs: temp 96, bp 125/80, hr 62 regular.  Other employees received flu shots from the same multi-dose vial without similar symptoms.									Y	12/04/2007	12/05/2007	1	None	UNK	UNK	Klonipin, Ambien		Allergy: TCN			1						1	Erythema; Pruritus; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA040AA~2~IM~~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0301715	12/28/2007	CA	66.0	66		M	12/21/2007	Information has been received from a physician concerning a 66 year old male who on 23-Aug-2007 was vaccinated with a 0.65 ml dose of Zostavax.  Concomitant therapy included a dose of influenza virus vaccine (unspecified).  On 29-Aug-2007 the patient developed a blistering rash around the injection site.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.				Y					U	08/23/2007	08/29/2007	6	Unknown	OTH	OTH	Unknown		Unknown		WAES0709USA00626	1						1	Injection site rash; Injection site vesicles	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~UN~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0301859	12/28/2007	GA				F	12/21/2007	Information has been received from a female who, on an unspecified date, was vaccinated with Zostavax and an influenza virus vaccine (unspecified).  No information was provided with regard to the patient's medical history and concomitant therapy.  Subsequently the patient experienced dizzy spells and vomiting.  The patient did not seek medical attention.  The patient noted she got the vaccines administered at the same time so she did not know which vaccine made her feel that way.  The patient outcome was not provided.  Additional information has been requested.									U				Unknown	OTH	OTH	Unknown		Unknown		WAES0709USA02051	1						1	Dizziness; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~UN~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0302090	12/28/2007	IL	67.0	67		M	12/21/2007	Information has been received from a registered pharmacist concerning a 67-year-old male with an allergy to codeine, hypertension, hypothyroidism and atrial fibrillation who on 01-OCT-2007 was vaccinated subcutaneous with a 0.65 ml dose of Zostavax (Oka/Merck).  Concomitant vaccines administered on 01-OCT-2007 included Pneumovax 23 (MSD) and influenza virus vaccine (unspecified).  On approximately 01-OCT-2007 (after vaccination) the patient developed a fever of 102 degrees and a rash at the injection site.  The patient sought medical attention via a phone call with their physician.  No diagnostic labs were performed.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  Follow-up information received on 22-OCT-2007: The reporter felt the adverse reaction was to the flu vaccine and not Zostavax (Oka/Merck).  Additional information is not expected.									N	10/01/2007	10/01/2007	0	temperature measurement, 102 degrees	OTH	OTH		Drug hypersensitivity, hypertension, hypothyroidism, atrial fibrillation			WAES0710USA00935	1						1	Body temperature increased; Injection site rash; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~~UNK~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0302163	12/28/2007	FL	58.0	58		F	12/21/2007	Information has been received from a physician concerning a 58 year old female who on 09-OCT-2007 was vaccinated SC on upper right arm with a 0.65 mL dose of zoster vaccine live (Oka/Merck). Concomitant therapy included a dose of influenza virus vaccine (unspecified) on left arm. On approximately 11-OCT-2007, 48 hours after vaccination the patient complained of pain and bruising at the injection site of the right arm. The patient was seen in the office on 12-OCT-2007 and in addition the patient also had burning and vesicles at the injection site of the right arm which the physician thought as shingles. The patient was treated with famciclovir. At the time of report the patient had not recovered. No diagnostic laboratory tests were undertaken. A product quality test was not involved. Additional information has been requested. Initial and follow-up information has been received from a physician concerning a 58 year old female who on 09-OCT-2007 was vaccinated SC in the upper right arm with a 0.65 ml first dose of ZOSTAVAX (lot # 658084/0888U). Concomitant vaccination included a first dose of influenza virus vaccine (unspecified) (U2440AA) given IM in the left deltoid. There was no illness at the time of vaccination. On 10-OCT-2007 (also reported as 48 hours after vaccination) the patient complained of pain and bruising at the injection site of the right arm. The patient was seen in the office on 12-OCT-2007 and in addition the patient also had burning and vesicles at the injection site of right arm which the physician thought was shingles. The patient was treated with fameiclovir. No diagnostic laboratory tests were performed. The patient recovered on an unspecified date within one week. There was no product quality complaint involved. Additional information is not expected.				Y					Y	10/09/2007	10/09/2007	0	None	PVT	PVT			Unknown		WAES0710USA02951	1						1	Herpes zoster; Inappropriate schedule of drug administration; Injection site bruising; Injection site irritation; Injection site pain; Injection site vesicles	FLU3~SANOFI PASTEUR~U2440AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~0888U~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0302199	12/28/2007	CO	79.0	79		M	12/21/2007	Information has been received from a nurse practitioner concerning a male with diabetes, history of heart disease, chronic lung disease (not related to smoking), sleep apnoea, hypertension, chronic insomnia, benign prostatic hyperplasia, osteoarthritis, history of pulmonary embolism and cerebrovascular accident and no known allergies who on 09-OCT-2007 was vaccinated subcutaneously with one dose of ZOSTAVAX (lot # 658212/0887U). There were no illnesses at the time of vaccination. Concomitant therapy included LIPITOR, AMARYL, LUNESTA, LYRICA, RODEX, ACTOS, ALEXAN, atenolol (MSD), FLOMAX, DIOVAN HCT, ENABLEX, PERCOCET and influenza virus vaccine (unspecified) that was administered in the left deltoid on 09-OCT-2007 in the morning(lot # U2446AA). On 11-OCT-2007 the patient developed shingles within 49 hours post vaccination. On 13-OCT-2007 the patient was seen again via an office visit and was treated with ZOVIRAX and steroids. On 16-OCT-2007 the patient was seen again via an office visit with the NP and there was no improvement in his symptoms. No diagnostic labs were performed. On an unspecified date the patient recovered. A product quality complaint was not involved. This is one two reports from the same source. Additional information is not expected.				Y					Y	10/09/2007	10/11/2007	2	None	PVT	OTH	PERCOCET; ATENOLOL MSD; LIPITOR; ENABLEX; LUNESTA; AMARYL; DIOVAN HCT; FLOMAX (MORNIFLUMATE); ACTOS; LYRICA; ALEXAN (SPIRONOLACTONE); RODEX (WARFARIN)	Diabetes; Chronic respiratory disease; Chronic insomnia; Osteoarthritis; Benign prostatic hyperplasia; Hypertension; Sleep apnoea; Cardiac disorder	Pulmonary embolism; Cerebrovascular accident		WAES0710USA03673	1						1	Herpes zoster	FLU3~SANOFI PASTEUR~U2446AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~0887U~UNK~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0302208	12/28/2007	CA	60.0			F	12/21/2007	Information has been received from a 60 year old nurse with controlled blood pressure, gastrooesophageal reflux disease (reported as GERD or NUD), bad knees, bungions, dry eyes, cough variant asthma and sulfonamide allergy who on 10-OCT-2007 was vaccinated with a dose of ZOSTAVAX 0.5 ml, IM for shingles recurrence prevention. Vaccines received the same day included influenza virus vaccine (unspecified) (manufacturer unknown). Concomitant therapy included PREVACID, RESTASIS, RESTORIL, SONATAm NORVASC, Solutab. The nurse reported that she was given ZOSTAVAX in one arm and influenza virus vaccine (unspecified) in the other arm. She reported that they both hurt but that the ZOSTAVAX hurt more than the flu shot. The pain lasted about 5 days to one week (date of recovery reported as 10-OCT-2007). The patient did not seek medical attention. There was no product quality complaint. No further information is available.									Y	10/10/2007	10/10/2007	0	None	OTH	OTH	therapy unspecified; NORVASC; RESTASIS; PREVACID; RESTORIL; SONATA	Blood pressure, Gastrooesophageal reflux disease; Unspecified disorder of knee joint; Bunion; Dry eye; Cough variant asthma; Sulfonamide allergy			WAES0710USA03979	1						1	Incorrect dose administered; Incorrect route of drug administration; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~IM~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0302222	12/28/2007	KS	78.0	78		M	12/21/2007	Information has been received from a 78 year old male with high blood pressure, rheumatoid arthritis and a bad case of chickenpox at age 13 and a penicillin allergy who on approximately 12-OCT-2007 was vaccinated with a single dose of ZOSTAVAX. Concomitant vaccination administered on that day included a dose of influenza virus vaccine (unspecified). Concomitant drug therapy included allopurinol; aspirin, VYTORIN, folic acid, hydrochlorothiazide, PLAQUENIL, methotrexate, LOPRESSOR, ACCUPRIL, ZOCOR, terazosin hydrochloride and other blood pressure and rheumatoid arthritis therapy. On 16-OCT-2007 the patient felt like he was getting a cold sore on his upper lip. Then he began experiencing itching on the buttock and his wife looked at and said it looked like a bunch of spider bites. The patient then developed small liquid filled lesions all over his body. The lesions have turned black and the liquid inside had dried up and started to crust. Medical attention was attempted by the patient contacting the physician without a call back. No labs or diagnostic studies were performed. The patient was noted to be recovering. There was no product quality complaint. Follow-up information has been received from a registered nurse indicating that the patient with a history of prostate cancer, coronary artery disease, hypertension, benign prostatic hyperplasia, hyperlipidemia and rheumatoid arthritis was vaccinated on 12-OCT-2007 with a SC dose of ZOSTAVAX (658839/1411U) in the left deltoid/arm. Concomitant vaccination administered on that same day included an IM dose of influenza virus split virion 3v vaccine inactivated (lot# U2528AA) in the right deltoid. Other concomitant drug therapy included allopurinol, ACCUPRIL 10 mg, HCTZ 25 mg, LOPRESSOR 125 mg, ezetimibe (+) simvastatin 10 mg/40mg, PLAQUENIL 200 mg BID and methotrexate 2.5 mg. On 16-OCT-2007 the patient developed a painful rash on his buttocks. No medical attention was sought. The outcome was unknown. Additional information has been requested.									N	10/12/2007	10/16/2007	4	None	PVT	PVT	allopurinol; aspirin; VYTORIN; folic acid; hydrochlorothiazide; PLAQUENIL; methotrexate; LOPRESSOR; ACCUPRIL; ZOCOR; terazosin hydrochloride	Blood pressure high; Rheumatoid arthritis; Benign prostatic hyperplasia; Cholesterol high; Coronary artery disease; Prostate cancer; Penicillin allergy	Chickenpox		WAES0710USA04388	1						1	Oral herpes; Pain of skin; Pruritus; Rash; Skin discolouration	FLU3~SANOFI PASTEUR~1411U~UNK~SC~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~U2528AA~UNK~IM~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0302237	12/28/2007	OR				F	12/21/2007	Information has been received from a nurse concerning a female who on 17-OCT-2007 was vaccinated with ZOSTAVAX 0.65 mL. Other concomitant vaccines included influenza virus vaccine (unspecified) and PNEUMOVAX. On 17-OCT-2007 the patient experienced pain and a lot of swelling at injections site, fever and loss of appetite. Therapy with ZOSTAVAX was discontinued. The patient's pain injection site and swelling at injection site and fever and loss of appetite persisted. The patient sought unspecified medical attention. Additional information has been requested.									N	10/17/2007	10/17/2007	0	Unknown	OTH	OTH			Unknown		WAES0710USA04684	1						1	Anorexia; Injection site pain; Injection site swelling; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~UN~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0302288	12/28/2007	NJ	78.0			M	12/21/2007	Information has been received from a 78 year old male with blood pressure high, enlarged prostate and glaucoma who on 22-OCT-2007 was vaccinated with ZOSTAVAX. Concomitant vaccine therapy that day included influenza virus vaccine (unspecified) (manufacturer unknown). Concomitant therapy included AVODART, COSOPT and PRILOSEC. At the time of reporting, 29 OCT 2007, the patient was recovering, and due to be seen by his physician that same day. There was no product quality complaint. Follow up information was received from the consumer who reported that he was experiencing violent diarrhea for four weeks and is under the care of two physicians. The consumer noted he did not think that this was related to the vaccine. It was also reported that unspecified blood work and a stool test were obtained, of which the results were not provided. The consumer did not provide physician contact information. No further information is expected. Additional information has been requested.									N	10/22/2007	10/23/2007	1	diagnostic laboratory; stool analysis	OTH	OTH	COSOPT; AVODART; PRILOSEC	Blood pressure high; Enlarged prostate; Glaucoma			WAES0710USA06070	1						1	Diarrhoea; Laboratory test; Stool analysis	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~UN~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0302291	12/28/2007	GA				F	12/21/2007	Information has been received from a physician concerning a female who was vaccinated SC with a dose of zoster vaccine life (Oka/Merck). Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient developed painful, itchy, shingle like blisters and rash at the injection site after vaccination. No further information was available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.				Y					U				Unknown	OTH	OTH			Unknown		WAES0710USA06126	1						1	Injection site pain; Injection site pruritus; Injection site rash; Injection site vesicles	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~SC~~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0302299	12/28/2007	TN	60.0	60		F	12/21/2007	Information has been received from a health professional concerning a 60 year old female with pre-existing allergies, birth defects and medical conditions which include: NOTUSS, LOPID, TRICOR, sulfa, CIPRO, KEFLEX, codeine, CLARITIN, AVELOX, CODICLEAR, decongestants, PREVACID, PNC, polylistfote.  Medical diagnosis included: PVD, hyperlipidemia, hypertension, GERD, HA and proteins deficiency as well as insomnia and anxiety, who on 16-OCT-2007 at 2:00 pm was vaccinated SC in the left arm with a first dose of ZOSTAVAX (Oka/Merck) (lot number: 658208/0886U).  On 16-OCT-2007 concomitant therapy included INFLUENZA VIRUS VACCINE (USP) (lot number: U250ZAA) in which she was vaccinated IM at 2:00 pm in the right deltoid.  On 16-OCT-2007 the patient experienced red, raised with heat, local rx around the injection site with no pain or itching.  Treatment included: apply ice as much as possible, take ZYRTEC 1 daily for 10 days and follow-up if symptoms persist.  On 22-OCT-2007 all symptoms were gone except for sore around injection site.  The outcome was reported as recovered.  There was no illness at time of vaccination.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/21/2007. Follow-up information indicated that all patient's symptoms resolved after 1-4 days of getting vaccine. Additional information has been requested.									Y	10/16/2007	10/16/2007	0	Unknown	PUB	OTH		Sulfonamide allergy; Peripheral vascular disorder; Hyperlipidaemia; Hypertension; Gastrooesophageal reflux disease; Insomnia; Anxiety; Protein C deficiency	Allergic reaction to antibiotics; Drug hypersensitivity		WAES0710USA06223	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Local reaction	FLU3~SANOFI PASTEUR~U250ZAA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~0886U~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0302313	12/28/2007		69.0			F	12/21/2007	Information has been received from a physician assistant concerning a 69 or 70 year old female who in October 2007, was vaccinated SC with a dose of zoster vaccine  live (Oka/Merck). Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unspecified) given in the other arm. Subsequently in October 2007 the patient experienced a rash at the injection site that went down her arm. Unspecified medical attention was sought. The physician assistant described the rash as looking like a severe case of cellulitis. There was no product quality complaint involved. The patient's outcome was not reported. No further information was provided. Additional information has been requested.				Y					U	10/01/2007	10/01/2007	0	Unknown	OTH	OTH			Unknown		WAES0711USA00094	1						1	Injection site rash	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0302358	12/28/2007	MA	66.0	66		M	12/21/2007	Information has been received from a physician concerning a 66 year old male with glaucoma, hypertension and dyslipidaemia who on 31-OCT-2007 was vaccinated with 0.65 ml of zoster vaccine live (Oka/Merck) (Lot# 658602/1080U). Concomitant vaccine therapy that same day included influenza virus vaccine (unspecified)(manufacturer unknown). The physician reports that the patient had no prior history of shingles, and on 06-NOV-2007 the patient developed zoster. No lab diagnostic studies were performed. Unspecified medical attention was sought. There was no product quality complaint. Follow up information was received from a physician through the Merck VZV identification program M-15786098391, who reported that on 31-OCT-2007 the patient was vaccinated with 0.5 ml (previously reported 0.65ml) of zoster vaccine live (Oka/Merck) (Lot# 658602/1080U) into the right arm, also reported as Zoster right hip. On 10 NOV 2007 (previously reported as 06 NOV 2007) the patient developed a rash with 8-10 lesions distributed on the right upper extremities, which was diagnosed as herpes zoster. The patient had no recent exposure to chickenpox or shingles. Concomitant medication included HCTZ, and FAMVIR 500 mg TID 2 weeks. At the time of reporting it was unknown if the patient recovered. Additional information is not expected.									U	10/31/2007	11/06/2007	6	None	OTH	OTH	FAMVIR, hydrochlorothiazide	Glaucoma, Hypertension, Dyslipidaemia			WAES0711USA01693	1						1	Herpes zoster; Rash; Skin lesion	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~658602/1080U~UNK~UN~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0302384	12/28/2007	CA	63.0	63		M	12/21/2007	Information has been received from a health professional concerning a 63 year old male with hypertension who on 25-OCT-2007, was vaccinated with zoster vaccine live (Oka/Merck). Concomitant vaccines included influenza virus vaccine (unspecified). On 26-OCT-2007, the patient developed shingles. He was seen in the physician's office and therapy was initiated with acyclovir. It was reported that the health care provider was not interested in varicella zoster virus analysis. Current patient status was not reported. A product quality complaint was not reported. Additional information was not available. Additional information has been requested.				Y					U	10/25/2007	10/26/2007	1	Unknown	OTH	OTH		Current Conditions: Hypertension			WAES0711USA00577	1						1	Herpes zoster	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~UN~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0302400	12/28/2007	AR	65.0	65		F	12/21/2007	Information has been received from a licensed practical nurse concerning a 65 year old female with high cholesterol, hypertension, osteoarthritis, gastroesophageal reflux disease, prednisone allergy, Terramycin allergy and penicillin allergy, who on 09-NOV-2007 was vaccinated SC on the right deltoid with a single 0.65 mL dose of zoster vaccine live (Oka/Merck) (Lot # 658602/1080U). Concomitant therapy included Diovan HCT, Norvasc, Daypro and a dose of influenza virus vaccine (unspecified). On 12-NOV-2007, the patient developed an injection site reaction. The reaction was described as 2X4 cm raised rash at the injection site area. The area of rash was described as warm, tender and itchy. Unspecified medical attention was sought. No diagnostic laboratory test were undertaken. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. Additional information has been received from the licensed practical nurse concerning this 65 year old white female with cholesterol high, hypertension, osteoarthritis, gastroesophageal reflux disease, prednisone allergy, penicillin allergy, seborrhoeic keratosis, skin tags, acute gastritis, hypertriglyceridaemia, anaemia, diverticular disease and a terramycin allergy who on 09-NOV-2007 at 11:52 was vaccinated SC in the right deltoid with a first dose of zoster vaccine live (Oka/Merck) (lot # 658602/1080U). Concomitant vaccination included a second dose of FLUZONE (lot # U2489AA) given IM in the left deltoid at 11:50. Additional concomitant therapy included DIOVAN HCT, NORVASC, DAYPRO, XALATAN and omega-3 marine triglycerides. Illness at the time of vaccination included a sore throat and post nasal drip. On 12-NOV-2007 the patient experienced injection site warmth, tenderness and pruritis. Below the injection site there was an erythematous pruritic rash. The patient was seen in the office on 12-NOV-2007. At the time of the report the patient had not recovered. Additional information has been requested.				Y					N	11/09/2007	11/12/2007	3	blood pressure, 11/12/07, 120/6 mmHg; body weight measurement, 11/12/07, 177 lbs; body temp, 11/12/07, 98.7 F; total heartbeat count, 11/12/07, 70; respiratory rate, 11/12/07, 12;	PVT	PVT	Norvasc; Diovan HCT; Daypro, Xalatan, omega-3 marine triglycerides	Cholesterol high; Hypertension; Osteoarthritis; Gastroesophageal reflux disease; Drug hypersensitivity; Penicillin allergy; Seborrhoeic Keratosis; Skin tags; Acute gastritis; Hypertriglyceridaemia; Anaemia; Divericular disease; Allergic reaction to antibiotics; Postnasal drip; Sore throat			WAES0711USA02634	1						1	Acrochordon; Anaemia; Blood cholesterol increased; Body temperature increased; Diverticulum; Drug hypersensitivity; Gastritis; Hypertriglyceridaemia; Injection site pain; Injection site papule; Injection site pruritus; Injection site rash; Injection site warmth; Oropharyngeal pain; Postnasal drip; Rash erythematous; Rash pruritic; Seborrhoeic keratosis	FLU3~SANOFI PASTEUR~U2489AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~1080U~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0302401	12/28/2007	TN	64.0	64		F	12/21/2007	Information has been received from a 64 year old female with codeine allergy and no medical history who on 08-NOV-2007 was vaccinated SC with first dose of zoster vaccine live (Oka/Merck). Concomitant therapy on same day but opposite arm included a dose of influenza virus vaccine (unspecified). Concomitant medications included (NASACORT), (ADVAIR), (MSD), (XANAX) and anti-depressant (unspecified). On 10-NOV-2007 the patient developed 3 X 1 inch red blotch near injection site. It was reported that the blotch was red, but there was no pain. The patient reported that the red blotch only itched when it was exposed to heat for example when taking a shower. No medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of report the patient  had not recovered. A product quality was not involved. Additional information  has been requested. This is in follow-up to report(s) previously submitted on 12/21/2007.  Information has been received from a 64 year old female with codeine allergy and no medical history who on 08-NOV-2007 was vaccinated SC with first dose of ZOSTAVAX (Merck) (lot# 0966).  Concomitant therapy on same day but opposite arm included a dose of influenza virus vaccine (unspecified).  Concomitant medications included NASACORT, ADVAIN, OMEPROZOLE (MSD), XANAX and anti-depressant (unspecified).  On 10-NOV-2007 the patient developed 3 x 1 inch red blotch near injection site.  It was reported that the blotch was red, but there was no pain.  The patient reported that the red blotch only itched when it was exposed to heat for example when taking shower.  No medical attention was sought.  No diagnostic laboratory tests were undertaken.  At the time of report the patient had not recovered.  A product quality was not involved.  Additional information from the physician indicated that the patient did not inform him about any reaction but after receiving correspondence from us he called the patient and asked about the reaciton.  The patient stated that she had a red streak on her arm that lasted for one week, she had no further problems and did not received treatment for it.  Additional information is not expected.									N	11/08/2007	11/10/2007	2	None	OTH	OTH	(therapy unspecified), XANAX, ADVAIR, PRILOSEC, NASACORT	Drug hypersensitivity			WAES0711USA02636	1						1	Erythema; Pruritus; Rash macular	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~1~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0300544	12/31/2007	CA		0	.0	U		Patient exhibited pleuritis type chest pain; elevated cardiac markers with peak (CKMB=6.4; Trop I=1.51); echo showing trace pericardial effusion.									Y	12/06/2007			Peak CKMB=6.4 Peak Trop I=1.51 Echo:  trace pericardial effusion, Normal LVSF	OTH	UNK		None	Asthma, Seasonal Allergies			1						2	Chest pain; Nuclear magnetic resonance imaging normal; Blood creatine phosphokinase MB; Blood creatine phosphokinase MB increased; Chest pain; Echocardiogram abnormal; Pericardial effusion; Troponin I increased	ANTH~EMERGENT BIOSOLUTIONS~UNKNOWN~3~UN~UN~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~UNKNOWN~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~PFIZER\WYETH~4020076~UNK~ID~UN~SMALLPOX (DRYVAX)~1|ANTH~EMERGENT BIOSOLUTIONS~~1~IM~LA~ANTHRAX (BIOTHRAX)~2|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|SMALL~UNKNOWN MANUFACTURER~~1~~LA~SMALLPOX (NO BRAND NAME)~2	USA		Influenza
0301248	12/31/2007	TX	0.5	0	.5	M	12/28/2007	Information has been received from a physician concerning a brestfed 6 month old male with no other pertinent medical history or drug allergies who on 15-AUG-2007, 12-OCT-2007 and 13-DEC-2007 was vaccinated PO with his first, second and third (lot# 656833/0407U) doses of Rotateq. Concomitant vaccinations administered on 13-DEC-2007 included a dose of Pediarix, a dose of Prevnar and a dose of ActHIB. On 13-DEC-2007 the patient vomited four times after being vaccinated and was not eating. The patient sought unspecified medical attention. On 14-DEC-2007 the patient had been taken to the hospital  and where he tested positive for intussusception. The patient had 2 air enemas, the second was successful). Other labs or diagnostic studies were performed but not specified. On 17-DEC-2007 the patient was recovered. It was noted that around the time of vaccination, the patient was transitioning from breast milk to formula. There was no product quality complaint. Additional information has been requested.  02/14/2008 Vax record received and info updated in database./pc 02/19/2008 MR received for DOS 12/14-15/2007 with D/C DX: Intussusception-ileocolic.  Infant presented to ER with 2 day hx of emesis and 1 episode of bloody, jelly-like stool. Pt dehydrated.  IS reduced on 2nd attempt by air contrast enema. Pt did well post procedure and D/Cd home next day.					Y	2			Y	12/13/2007	12/13/2007	0	abdominal X-ray 12/14/07 2nd air enema successful; abdominal X-ray 12/14/07; laboratory test 12/14/07 unspecified.  Labs and Diagnostics:  Abdominal US (+) for IS. Air contrast enema (+) for ileocolic IS.	OTH	OTH		Breast feeding	PMH: none NKDA.		WAES0712USA08439	1						1	Abdominal X-ray; Enema administration; Laboratory test; Oral intake reduced; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B129AA~3~UN~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2481EA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF113AA~3~UN~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B58845C~3~UN~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0407U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0301264	12/31/2007	NC	1.17	1	.1	F	12/31/2007	Patient had a quarter size lump on her thigh.									Y	12/19/2007	12/22/2007	3		PVT	PUB		None				1						1	Injection site mass	FLU3~SANOFI PASTEUR~U2490AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1501U~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0301274	12/31/2007	OH	55.0	55		F	11/06/2007	1st 3 days: fever, chills, exhaustion, left arm red, swollen and complete immobile. I was immobile mostly that time. Numbness in left arm and leg and still have swelling.									N	11/01/2007	11/01/2007	0		OTH	PVT	None	None				1						1	Chills; Erythema; Fatigue; Hypoaesthesia; Mobility decreased; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~U2513AA~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0301276	12/31/2007	UT	27.0	27		F	12/20/2007	11-26-07 pm temp 102 deg F Pinpoint rash over entire body except for face and hands. rash warm to touch. Hands swollen. Dr at medical center Rx for antihistamine. No change in rash after taking Rx Dr prescribed Prednisone x 12 d plus another Rx pt did not remember name. Rash gone continues with some itching, swelling in hands.				Y					U	11/26/2007	11/26/2007	0	None	PUB	PVT	Ortho Tricyclen	None	None			1						1	Body temperature increased; Oedema peripheral; Pruritus; Skin warm	FLU3~SANOFI PASTEUR~U2504AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0301277	12/31/2007	IA	14.0	14		F	12/26/2007	Mother reported site of varicella injection red, sore.  Next day - 12/21 - swelled to size of softball.  12/22 - very inflamed - saw doctor in emergency room.  Gave steroid shot.  Remains on Prednisone 20 mg vial for 5 days.  Swelling, inflammation decreased 12/26/07.				Y					Y	12/20/2007	12/21/2007	1		PUB	PUB	None	None	None			1						1	Injection site erythema; Injection site inflammation; Injection site pain; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80959~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARCEL~MERCK & CO. INC.~1509U~2~~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0301278	12/31/2007	WI	1.5	1	.5	F	12/21/2007	Ulcer and induration at injection site. Treated with antibiotics for presumed cellulitis.									U	12/10/2007	12/19/2007	9	None	PVT	PVT	None	No	No			1						1	Cellulitis; Injection site induration; Injection site ulcer	FLU3~SANOFI PASTEUR~UT2456AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0301279	12/31/2007	MD	11.0	11		F	12/26/2007	Pain, swelling and redness of injection site associated to chills and axillary adenopathy. Site to Tdap.				Y					Y	12/18/2007	12/18/2007	0		PVT	PVT	No	No	No			1						1	Chills; Injection site erythema; Injection site pain; Injection site swelling; Lymphadenopathy	FLU3~SANOFI PASTEUR~U2448AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2429AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2826AA~1~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0301280	12/31/2007	NE	4.0	4		F	12/17/2007	red swollen area size of tennis ball around shot areas. Mostly around area where flu shot would have been given. Noticed redness and swelling approx 2 days later. Resolved without meds other than mother applied Bacitracin x 1.									Y	11/14/2007	11/16/2007	2		PUB	PUB		None	None			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2524AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0747U~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08702H~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1184U~2~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0301270	01/01/2008	CO	38.0	38		F	01/01/2008	Initial dizziness, nausea, weakness (all very mild, and disappeared within about 15 minutes).  Within 1/2 hour, numbness in left index finger, thumb, and small area surrounding affected digits.  Numbness eventually got slightly better, but 10 days later, slight numbness still remains in finger and thumb.  Not debilitating, but somewhat annoying. Follow up to form completed on 1/01/2008:  The numbness in index finger and thumb is still present, although some improvement has occurred as of 01/30/2008.  On the morning of 01/02/2008, I noticed that my left shoulder area (injection site) was quiet sore, and range of motion was greatly diminished (to the point where I had to alter sleeping positions and was unable to wash back in shower).  The pain was constant until just a few days ago, when probably 90 percent of the pain suddenly cleared up.  My main concerns are: Will I be able to received flu vaccinations in the future?  Should I be wary of other vaccinations such as tetanus, whooping cough, etc? If I receive vaccinations in the future, should I request a different injection site such as abdomen, buttocks or thigh?									N	12/22/2007	12/22/2007	0	None	UNK	UNK	Loratadine (Member's Mark Brand - Sam's)	None	None			1						1	Asthenia; Dizziness; Hypoaesthesia; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA305BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301357	01/02/2008	MN	1.02	1	.0	M	01/02/2008	Full course of chicken pox.  Fever of 104.2 began 12/28/07, lasted until 12/30/07.  Fever then went down to 102 during the day.  Chicken Pox began on 12/28/07 and continued on until 1/2/08 at which time they are fading away.  Fever broke on 12/31/07.									Y	12/20/2007	12/28/2007	8		UNK	UNK						1						1	Pyrexia; Varicella; Varicella post vaccine	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~2~IM~RL~INFLUENZA (SEASONAL) (FLUARIX)~1|MEA~MERCK & CO. INC.~~1~SC~LL~MEASLES (ATTENUVAX)~1|VARCEL~MERCK & CO. INC.~1271U~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0301411	01/02/2008	WA	9.0	9		M	01/02/2008	Pt had lump at injection site that evening.  Redness and swelling began on 1/1/2008.									Y	12/31/2007	01/01/2008	1		UNK	UNK			Extreme prematurity.  Chart with extensive medical history not in our office.			1						1	Erythema; Injection site mass; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80956~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARCEL~MERCK & CO. INC.~1509U~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0301413	01/02/2008	MD	58.0	58		F	01/02/2008	2130 hrs; 10-17-07; Low back pain, radiating down posterior thighs. Numbness/ tingling left foot; N/T bilateral hands with neck flexion. 10/22/07: PCP ordered Ultram, Flexeril and Dexamethasone PO. Post 48 hrs, N/T increased in right foot. Hosp Admission:10-26 to 10-30-07; Dx: Bell's Palsy. N/T progressive lower extremities; muscle weakness increased, hand tremors. PCP ordered Solu-medrol dose pk and PT. Weakness increased.  11/18/07:Severe pain, weakness and tremors; to ED then admitted to Medical Center 11-18-07; neurology floor. Spinal tap: protein 307. Multiple labs: MS vs neurosarcoidosis. Treated with 1000mg IV solumedrol x 6 days. GMI antibody & Visual Evoke Potential with EEG: ruled out MS. EMG lower extremities: Chronic Demyelinated Polyneuropathy; consistent with Guillain Barre' Syndrome.  Plasma phoresis to start 1/3/08 x 5. Possible IVIG administration after plasmaphoresis. Employee last day of work; 10/25/07.    1/8/08 Reviewed hospital medical records which reveal patient experienced numbness & weakness of right side of face since 10/26/07 with back & leg pain.  Admitted 10/26-10/30/2007.  Consults by Neuro, Neurosurgery & GYN done.   FINAL DX: right facial Bell's palsy; cervical & lumbar disk prolapse; left ovarian mass; DM; primary biliary cirrhosis; hx of sarcoidosis in remission.    1/25/08 Received hospital medical records for 11/19-11/26/2007.  Had developed URI symtoms s/p d/c from initial hospital.  Neuro exam revealed right side Bell's phenomenon & Bell's palsy, severe low back pain, diffuse asymmetric weakness of bilateral legs w/significant gait impairment, hyperreflexia & bilat Babinski.  Neurosurg, Neurology consults done.  LP done.  Tx w/IV steroids & did improve to be able to ambulate w/wheeled [[name]].  D/C to home on continued steroids w/outpatient PT & further neuro w/u to be done.   FINAL DX: probable multiple sclerosis. 3/14/08 Reviewed hospital outpatient plasmapheresis records & labs which reveal patient received tx 1/3-1/14/2008 x 5 doses.  With initial tx experienced severe muscle cramping & was seen in ER.  Dx w/muscle cramping s/p plasmapheresis, HTN, esophageal pathology, GBS & hx of Bell's palsy.  D/c to home w/meds.  3/21/08 Reviewed neuro office notes of 12/7/2007-3/19/2008. FINAL DX: Guillian Barre syndrome Initial vs of 12/7/07 reveals patient experienced LBP & leg pain, paresthesias & weakness of legs & arms, Bell's palsy, difficulty voiding.  Recently dx w/MS.  Using wheeled [[name]] for ambulation but had been walking 2 [[name]]/[[name]] prior to this illness.  Exam revealed right facial paresis & unable to completely close right eye; gait stiff & unstable.  Referred for plasmapheresis x 5 doses.  Improved to be able to ambulate w/quad cane; prednisone weaned; returning to PT.  On 3/19 vs, was greatly improved but w/pain in various joints.  Allowed to return to work part time & referred to rheumatologist. Per 60 [[name]] follow up: Facial paralysis continues; requires cane for ambulation; tires easily/ physical threapy continues for strengthing endurance and balance. Concerned over medical bills-unable to work since 10/17/07. States unable to comply with $250.00 fee for program. 1/15/2010 Continues to recover from Guillain Barre Syndrome, facial paralysis, muscle weakness and fatigue.				Y	Y	11	Y		N	10/10/2007	10/17/2007	7	CT head/ MRI spine; x-ray LS spine, cervical spine; Bulge L 4-5, not correlated to symptoms. MRI head, Spinal tap:  protein 307. See above LABS: CT of head WNL.  MRI of spine revealed multiple bulging disks of lumbar & cervical spine.  CT of abdomen revealed left ovarian mass.  3/5/08 Reviewed labs from 2nd hospitalization.  No EMG report included: LABS: WBC 3.9 (L), plts 102 (L), monos 13% (H).  Sed Rate 43 (H).  ANA (+).HA1C 6.5 (H).  Chemistry WNL.  CK 198 (H), cardiac enzymes neg.   CSF: WBC 3 (N), total protein 307 (H), glucose 135 (H), olig bands neg, ACE neg, c/s neg.  Alk Phos 313 (H), AST 71 (H), ALT 94 (H), GGTP 396 (H).  IgG 1550 (H), IgG3 177 (H).  MRI brain WNL.  Venous duplex exam neg for DVT.  Visual evoked potential WNL.  LABS: EKG sinus tachycardia.  CT chest neg for PE but revealed esophageal problems & splenomegaly.  Visual evoked potential of 12/11/07 WNL.    LABS: EMGs 12/18 & 1/17 revealed diffuse motor/sensory polyneuropathy.  Alk phos 247(H); AST 55(H); ALT 120 (H). Plts 93K (L).  B12 >1200 (H).  Lyme titer & West Nile neg.	UNK	UNK	Synthroid 0.05mg q day, metformin 500 mg BID, Nexium 40mg q day, Actigal 300mg TID, Advair inhaler 250 prn	No acute illness other than noted medical conditions.	Pulmonary Sarcoidosis, Primary biliary cirrhosis, DM type 2, hypothyroidism. Allergic reaction to PPD; affected arm swelling/ cellulitis PMH: shingles 14 yrs ago; Type 2 diabetes.  Erosive gastritis.  Splenomegaly. Daughter w/RA.			1						1	Antibody test negative; Back pain; CSF protein increased; Demyelinating polyneuropathy; Electrocardiogram abnormal; Electroencephalogram normal; Electromyogram abnormal; Extensor plantar response; Facial palsy; Facial palsy; Fatigue; Glycosylated haemoglobin decreased; Guillain-Barre syndrome; Hypoaesthesia; Lumbar puncture; Multiple sclerosis; Muscle spasms; Muscular weakness; Oesophageal disorder; Pain; Pain in extremity; Paraesthesia; Plasmapheresis; Sinus tachycardia; Spinal X-ray abnormal; Splenomegaly; Tremor; Visual evoked potentials normal	FLU3~SANOFI PASTEUR~U2498AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0301427	01/02/2008	GA	36.0	36		F	10/27/2007	None - but pregnant woman - vaccine said not suitable for pregnancy.									Y	12/10/2007				PVT	PVT		Pregnant				1						1	Drug exposure during pregnancy; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0301429	01/02/2008	OH	5.0	5		F	11/28/2007	3-4 swelling/erythema R arm at site.									U	11/09/2007	11/20/2007	11	None	PVT	PUB	None	None	Congenital Malaria	~Measles + Mumps + Rubella + Varicella (ProQuad)~2~4.00~In Patient		1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2465AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0301430	01/02/2008	WI	4.0	4		M	12/17/2007	Pronounced swelling, redness and warmth locally									Y	12/13/2007	12/14/2007	1		PVT	UNK		None	cats			1						1	Injection site erythema; Injection site swelling; Injection site warmth	DTAP~SANOFI PASTEUR~C2657AA~1~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2476GA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0126~1~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|VARCEL~MERCK & CO. INC.~1556U~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0301432	01/02/2008	OR	28.0	28		M	12/27/2007	Pt c/o (L) arm pain x 7 days after injection then burning to left arm with increasing severity. Loss of strength on Sat. Diagnosed with possible Brachial Plexis irritation (L) arm pain.  1/8/08 Reviewed clinic medical records which reveal patient seen 12/21/07 with left shoulder pain x 7 days.  Exam revealed limited flexion/extension of left shoulder w/pain.  DX: myalgia, myositis.  Returned to clinic on 12/27 s/p ER visit for left shoulder/arm pain, sore throat & runny nose.  Dx in ER w/brachioplexy.  Referred to neurology.  Exam on 12/27 revealed positive impingement sign w/decreased left arm strength. FINAL DX: brachial neuritis.									U	12/06/2007	12/06/2007	0		PUB	PUB	Atenolol 25 mg every day	HTN Hx. Diverticulitis Hx. Self-Reported	Latex allergy PMH: left shoulder injury in past.			1						1	Asthenia; Brachial plexus injury; Burning sensation; Pain in extremity	FLU3~SANOFI PASTEUR~U2515AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0301433	01/02/2008	OR	2.0	2	.5	M	12/26/2007	The patient developed high fever about 5 min. after flu vaccine administered. Symptoms lasted about 10 hours. No GI illness or rash developed after vaccinations. No increase in URI Sx's developed (Temp reached 106 deg)									Y	12/21/2007	12/21/2007	0		PVT	PVT	Tylenol 2.5% hydrocortizone cream	ear infection and URI	Eczema			1						1	Pyrexia	FLU3~SANOFI PASTEUR~UT2459MA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0301434	01/02/2008	IL	1.5	1	.5	M	12/21/2007	Mom took child to ER on 12/20/07 due to (R) leg being red, swollen, and warm. Diagnosed with cellulitis per mom. Give antibiotics via shot and sent home and told to see primary doctor. Also prescribed abx.				Y					Y	12/19/2007	12/20/2007	1		PUB	PUB						1						1	Cellulitis; Injection site erythema; Injection site swelling; Injection site warmth	DTAPH~SANOFI PASTEUR~UF196AA~4~IM~RL~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~UT2460EA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB182AA~1~IM~LL~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0301435	01/02/2008	TX				U		None Stated														UNK	UNK						1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2437AA~5~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0301437	01/02/2008	CA	6.0	6		M	12/19/2007	Pt is a 6 m male with irritability early this morning, had non-rhythmic shaking movements of upper and lower extremities without organization, seemed chilled to mother though body was hot; a pool of spittle nearby, but that is not abnl for him, as he is teething; Mother states eyes appeared somewhat glazed, period lasted about 2 minutes, and when ended, he seemed more placid and restful; he fell asleep shortly after and awakened his usual time of 6 AM and has seemed normal since, though felt a bit warm on awakening and given infant advil; he fed well at 6 AM; Pt seen yesterday for WB visit and was no ill; he was given flu, Pediarix, HIB and Prevnar, Rotateq, he had had all of these x2 prior, with exception of flu; At 3 months, prior to coming to this area, he had 103 documented temp within 24 hrs of 1st immunizations, consisting of Combivax, DTaP, Prevnar and Rotateq; no intervention required and no sequelae; Pt without perinatal or dev concerns and no fam hx of epilepsy or neurological problems									Y	11/30/2007			None	PVT	PVT		No	No	Fever~Hib + Hep B (Comvax)~1~0.17~In Patient		1						1	Body temperature increased; Inappropriate schedule of drug administration; Irritability; Lacrimation increased; Medication error; Skin warm; Tremor	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B125BB~2~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2456DA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF160AA~2~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B53981E~UNK~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0768u~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0301438	01/02/2008	MO	1.0	1	.0	F	12/24/2007	Child was given Flumist instead of injectable flu vaccine for 6-36 months; There were no adverse effects, but the wrong kind of flu was given for the wrong age, doctor said to report									Y	11/12/2007				PUB	PUB	None	None	None			1						1	Inappropriate schedule of drug administration; Medication error; Wrong drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~50049P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HIBV~SANOFI PASTEUR~UF192AA~4~UN~LL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~02820~1~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08700H~4~UN~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~13290~1~UN~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0301445	01/02/2008	IL	56.0	56		F	12/18/2007	Pain & soreness on arm in area of vaccine for the last 5 weeks.  Hurt to raise arm over head, lift or carry objects.  Currently taking Aleve twice daily for 10 days.				Y					N	11/10/2007	11/12/2007	2		UNK	PVT		None	None			1						1	Injected limb mobility decreased; Injection site pain	FLU3~SANOFI PASTEUR~U2514AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0301446	01/02/2008	CA	27.0			M	12/13/2007	IM influenza vaccine was mistaken for Flu Mist and administered to the nasal passage as a liquid. Once mistake was determined it was given IM										12/09/2007			None	MIL	MIL		None	None			1						1	Incorrect route of drug administration; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IN~NS~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301447	01/02/2008	CA	19.0	19		M	12/13/2007	IM Influenza vaccine was mistaken for Flu Mist and administered to the nasal passage as a liquid. One mistake was determined it was given IM										12/09/2007			None	MIL	MIL		None	None			1						1	Incorrect route of drug administration; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IN~NS~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB433AA~3~IM~~HEP B (ENGERIX-B)~1	USA		Influenza
0301448	01/02/2008	CA	18.0	18		U	12/31/2007	IM influenza vaccine was mistaken for Flu Mist and administered to the nasal passage as a liquid. Once mistake was determined it was given IM										12/09/2007			None	MIL	MIL		None	None			1						1	Incorrect route of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLVA316BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB433AA~1~IM~UN~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB139AA~2~IM~UN~HEP A (HAVRIX)~1	USA		Influenza
0301449	01/02/2008	CT	0.9	0	.9	F	01/02/2008	Urticaria to all body on next day after administration of Fluzone vaccine.									U	12/27/2007	12/28/2007	1	None	PVT	UNK	Amoxicillin	Otitis Media	None			1						1	Urticaria	FLU3~SANOFI PASTEUR~UT24UEA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0301451	01/02/2008	LA	61.0	61		F	12/06/2007	Pt reports redness and swelling to face and eyelids red and puffy. Saw PMD on 12/3/07 and was sent for blood work. Possible allergies to Satsuma trees, foods.									Y	11/28/2007	11/29/2007	1	Blood work drawn on 12/10/07.	PUB	PUB	None	None	NKA			1						1	Blood test; Erythema of eyelid; Eyelid oedema; Swelling face	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80959~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0301452	01/02/2008	OR	62.0	62		F	01/04/2008	Local swelling, swollen lymph nodes, localized pain.									Y	12/11/2007	12/13/2007	2		PVT	UNK	Toprol XL	None	HTN			1						1	Local swelling; Lymphadenopathy; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78478~6~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0301453	01/02/2008	KY	4.0	4		M	01/02/2008	Erythematous and edematous area 6 3/4in by 5 3/4in on right thigh.  No breaks in skin.  Even this has become erythematous, has increased today.									U	12/31/2007	12/31/2007	0	None	PUB	PUB		Bacterial conjunctivitis	Latex allergies, asthma			1						1	Injection site erythema; Injection site oedema	DTAP~SANOFI PASTEUR~C2431AA~5~~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2508AA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0273~4~~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0412U~2~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1577U~2~~~VARICELLA (VARIVAX)~1	USA		Influenza
0301454	01/02/2008	FL	0.18	0	.2	M	01/02/2008	Flu vaccine was administered in error by MA. Medical director notified. No adverse reaction. Parents notified of error.										01/02/2008	01/02/2008	0	N/A	PVT	PUB		Constipation, Jaundice, Atopic dermatitis	N/A			1						1	Wrong drug administered	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B114CA~1~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2477DA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF216AA~1~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B54015E~1~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0410U~1~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0301455	01/02/2008	IL	76.0	76		F	01/02/2008	One week following shot area scaling, then scabs for 3 weeks. Still has redness 1-2-08; small red area. No itching no fever, no aching.									Y	11/26/2007	12/04/2007	8		PUB	PUB	Glucophage, Amayrl, Coreg, Hyzar; Slonacin	None	Diabetes, Hypertension			1						1	Erythema; Injection site scab; Scab; Skin exfoliation	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80073~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0301456	01/02/2008	CA	0.8	0	.8	F	11/27/2007	Patient given wrong dose of flu.  0.5 ml instead of 0.25 ml.  Called CDC for instructions, give 2nd dose, 4 wks age appropriate dose.									Y	11/26/2007	11/26/2007	0	None	OTH	PUB	None	None	None			1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~U2435AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0301458	01/02/2008	MA	77.0	77		F		Patient arrives 12/11/07 s/p flu shot at Heritage.  11/7/07 patient reported bruising at site since 11/9/07 x 2 weeks with return ecchymosis with INR drawn on 12/5/07.  X-ray: negative foreign body, negative fx, negative bursitis.  Labs: CBC nl except hot 35.1 (Sl down), INR 2.4/Plat 252.										11/07/2007				OTH	PVT		None				1						1	Full blood count normal; Injection site bruising; Injection site haemorrhage; International normalised ratio; X-ray normal	FLU3~SANOFI PASTEUR~62451AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0298543	01/03/2008	IL	68.0	68		M	12/03/2007	Client states that he experienced pain, redness and swelling at injection site a few hours after vaccination on 11/19/07. He went to the emergency room on 11/21/07 due to worsening condition at the injection site. He stated he was treated with IV antibiotics for cellulitis and put on an oral course of antibiotics with an uneventful recovery.				Y					Y	11/19/2007	11/19/2007	0	unknown	UNK	UNK	unknown	unknown	unknown			1						2	Cellulitis; Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2489AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1132U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0299912	01/03/2008	MN	46.0	46		F	01/03/2008	Complaints of numbness and tingling in the feet, generalized weakness that started several days prior to admission.  The patient's initial symptoms were mild but progressively worsened which prompted her to seek medical attention.  The patient did have a fall at home.  1/18/08 Reviewed hospital medical records which reveal patient experienced progressive generalized weakness & falls x 5-6 days prior to admit w/tingling in bilateral legs which progressed to involve tongue & fingers. Admitted 11/28-12/06/2007 to ICU for respiratory concerns.  On exam DTRs absent, unsteady gait, decreased sensation.  Neuro, Renal, Psych & ST consults done.  Tx w/plasmapheresis x 5.  While hospitalized, developed Bell's palsy.  Slow improvement & transferred to inpatient rehab 12/6-12/14/2007 for continued PT/OT.  Not much progress until received 2 more plasmapheresis treatments while in rehab, then progressed well.  D/C to home w/PT, Neuro & pcp f/u as outpatient. FINAL DX: Guillain-Barre syndrome. 1/24/08 Received EMG/NCS report of 11/29/07 which concludes acute inflammatory demyelinating polyneuropathy.				Y	Y	16			N	11/12/2007	11/25/2007	13	Normal CBC with differential.  Electrolytes:  Sodium 136.  BUN 15.  Most recent creatinine 0.7.  Magnesium 2.4, calcium 9.7, CRP 0.4.  Cholesterol last year 199, triglycerides 66, HDL 59, LDL 118.  TSH 3.18.  B12 644.  Brain MRI from 11/28:  Study degraded by motion artifact. No obvious acute infarction or demyelinating changes.  Cervical MRI: Multilevel mild degenerative changes without evidence of cord nerve root impingement or intrinsic cord abnormality.  Small posterior disk bulge, noncompressive annular tear at 6-7.  Motion artifact degraded.  MRI thoracic spine with  no evidence for any cord lesions or canal compromise.  Minor degenerative changes. LABS: MRI brain & spine WNL.  EMG/NCS revealed acute inflammatory demyelinating polyneuropathy or GBS.  LP revealed CSF protein 176 (H) & IgG 31.6 (H)	UNK	UNK	Seroquel 100 mg in the morning, 500 at bedtime; Effexor XR 150-mg capsules, 1 in the morning, 2 at bedtime; clonazepam 0.5 mg 3 in the morning, 2 in the afternoon, 2 in the evening		Depression, bipolar disorder, low back pain			1						2	Asthenia; Blood calcium normal; Blood cholesterol normal; Blood creatinine increased; Blood electrolytes increased; Blood magnesium increased; Blood sodium normal; Blood thyroid stimulating hormone; Blood triglycerides normal; Blood urea normal; C-reactive protein normal; Fall; Full blood count normal; Hypoaesthesia; Nuclear magnetic resonance imaging brain normal; Paraesthesia; Total cholesterol/HDL ratio normal; Vitamin B12 normal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA321CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Hospitalisation	Influenza
0301590	01/03/2008	IA	51.0	51		F	01/03/2008	Rt arm was red, hot, swollen night of vaccination. Remained red, hot, swollen & painful for 2 weeks.  Redness, heat & swelling gone after 2 weeks but remains painful to move or use R arm to present date.									N	10/25/2007	10/25/2007	0	None	UNK	UNK		None	ASA, aerosol sprays, Procardia, latex			1						1	Erythema; Injected limb mobility decreased; Oedema peripheral; Pain in extremity; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA307BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301592	01/03/2008	WY	5.0	5		M	01/02/2008	Vaccines were administered at approximately 10:10 am. Sister received vaccines. When leaving, patient walked into the wall. His body was rigid and he had some jerking motions to his extremities, He slumped to the floor against the wall after hitting his face and head. His face, lips, gums, anad tongue were blue. Patient was not responding. Pulse 62. Positioned for a patient airway. O2 at 2 liters/min. At 10:25 am .2ml. of epinephrine was given, Patient opened his eyes, but wasn't talking. He was incontinent of stool and the estimated time of seizure activity was 30 seconds. 911 was called. At 10:26 am pulse 72, BP 68/41, Resp. 22. Was pale. Alert and talking. Remembers only that his head started to hurt. Lungs clear. Pulse oximeter 98%. Ambulance arrived. Taken to the emergency room. Mom reported patient was all right. Became light-headed and fell. No allergic reaction. CAT scan ok.				Y					Y	01/02/2008	01/02/2008	0	blood work, CAT scan	UNK	UNK						1						1	Abnormal behaviour; Blood test; Computerised tomogram; Convulsion; Cyanosis; Dizziness; Dyskinesia; Face injury; Faecal incontinence; Fall; Head injury; Headache; Muscle rigidity; Oxygen supplementation; Pallor; Tongue discolouration; Unresponsive to stimuli	FLU3~SANOFI PASTEUR~U2509AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1518U~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0301596	01/03/2008	MN	57.0			M	01/03/2008	Presented to the emergency room with a chief complaint of weakness and tingling in the extremities for 3 days.  It started with tingling and numbness in his hands, followed by foot.  It involves all his fingers up to just below shoulder, and also his toes.  Feels that he is in balance.  He also complains of mild headache.  Denies any history of dysarthria, visual changes.  He had a recent vaccination a couple of weeks ago, prior to his symptoms.  No history of any upper respiratory tract infection. 1.  Guillain-Barre syndrome. His EMG was abnormal, consistent with demyelinating neuropathy.  He had a spinal tap, which revealed elevated protein.  He was started on plasmapheresis on 10/27/07. He had a pleural catheter placed by Nephrology.  So far, he received 5 plasmapheresis.  His symptoms are better.  He is actively participating in physical therapy. 2.  Hypertension.  His blood pressure was elevated in the hospital.  He was started on Norvasc.  Will continue Norvasc 10 mg p.o. daily.  Will avoid ACE inhibitors as he is on plasmapheresis. 3.  Nonobstructive 10-mm left renal mid pole calculus. Asymptomatic. 4.  GERD.  He was started on Prilosec. 1/18/08-records received for DOS 10/24-11/2/07-DC DX: Guillain-Barre syndrome. Hypertension. GERD, nonobstructive 10-mm left renal mid pole calculus. Presented to ER with C/O weakness and tingling in extremities for 3 days. Tingling began then followed with numbness in hands, followed by foot. Involves all his fingers and up to shoulders and toes. Headache. Treated with plasmapheresis. Transferred to inpatient rehab.  Ongoing paresthesias. Significant weakness initially, requiring hospitalization and several months of therapy and time off work. Now recovering from GUILLAIN-BARRE syndrome and effects. Now complete recovery except for mild fatuge and paresthesis.				Y	Y	22			Y		10/21/2007		WBC 5.9, hemoglobin 15.1, platelets 104.  INR 1.0.  BUN 30, creatinine 0.8, sodium 141, potassium 2.8.  Total bili 0.08 AST 48, ALT 44.  Chest x-ray, no active disease.  CT scan, head, without contrast showed mild prominence of both frontal horns of the lateral ventricular, without definite hydrocephalus.  CT scan, abdomen and pelvis, showed nonobstructive similar to left renal mid pole calculus.  MRI of the cervical spine shows normal cervical spine.  MRI, brain, showed no evidence of acute infarct. 1/18/08-records received- EMG abnormal consistent with demyelinating neuropathy. Spinal tap revealed elevated protein. CT scan head mild prominence of both frontal horns of lateral ventricular without definite hydrocephalus. CT scan nonobstructive renal mid pole calculus. MRI cervical spine normal. MRI brain no acute infarct.	UNK	UNK	None		PAST MEDICAL HISTORY: 1.  History of melanoma, 7 years ago. 2.  Bilateral ganglion cyst removal. 1/18/08-records received-PMH: melanoma. Several months ago had 20 pound weight loss, intermittent bloody stools over 2 month interval.			1						1	Alanine aminotransferase increased; Aspartate aminotransferase increased; Blood bilirubin; Blood creatinine normal; Blood potassium decreased; Blood sodium normal; Blood urea increased; CSF protein increased; Chest X-ray normal; Computerised tomogram abnormal; Demyelinating polyneuropathy; Electromyogram abnormal; Gastrooesophageal reflux disease; Guillain-Barre syndrome; Haemoglobin increased; Headache; Hypertension; Hypoaesthesia; International normalised ratio decreased; Lumbar puncture; Muscular weakness; Nephrolithiasis; Nuclear magnetic resonance imaging normal; Paraesthesia; Plasmapheresis; Platelet count decreased; White blood cell count	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0301597	01/03/2008	MN	66.0	66		M	01/03/2008	History of having had an upper respiratory tract infection 2 weeks ago, for which he was treated symptomatically with over-the-counter medications.  He was immunized with the influenza vaccine on 12/18/07.  Following this, on 12/22/07, he developed tingling/numbness in the fingers of both hands and the toes of both feet.  It gradually progressed to involve his hands the next day, associated with a feeling of weakness in his hands and feet.  He also developed imbalance and felt unsteady when walking.  He does not give a history of shortness of breath, dysphagia, double vision, or dysarthria. There is no history of neck/back pain or radicular symptoms in his extremities. He was admitted, Neurology was consulted in regard to his care. He was started on IVIG. He received 5 days of IVIG and was recommended to continue with physical therapy, occupational therapy. At time of transfer to Rehab, he is about 50% back to his baseline, continues to have some numbness in his hands.  1/18/08 Reviewed hospital medical records which reveal patient experienced progressive foot/hand tingling, weakness, decreased hand grip, difficulty walking x 4 days.  When received flu vax at clinic vs of 12/18 had improving URI symptoms w/dry cough.  Admitted 12/26-12/31/2007.  Neuro consult done.  Tx w/IVIG x 5 w/some improvement.  Transferred to inpatient rehab 12/31/2007-1/04/2008.  Developed right shoulder pain while in hospital & dx w/impingement & rotator cuff tendonitis & was tx by Ortho w/steroid injection w/good results.  D/C to w/continued PT, Neuro & Ortho f/u as outpatient. FINAL DX: Guillain-Barre syndrome; axonal peripheral polyneuropathy, sensory axonal neuropathy; possible right CTS. 1/24/08 Received EMG/NCS of 12/27/07 which concludes mixed sensory/motor polyneuropathy w/axonal & demylinating features.					Y				Y	12/18/2007	12/22/2007	4	CBC/platelets/differential showed evidence of mild anemia with low hemoglobin and hematocrit, and also elevated neutrophils. His ESR was high at 18.  His basic metabolic profile was normal, but glucose was elevated at 117.  Laboratory tests from 12/04/07 showed a hemoglobin A1c of 6.4 and microalbuminuria.  His fasting lipid panel was normal. A head CT without contrast was performed on 12/26/07.  It showed mild to moderate cerebral/cerebellar volume loss, a benign arachnoid cyst in the right frontal lobe and multiple subcutaneous masses overlying the parietal and occipital bones bilaterally, so many of which were associated with areas of calcification.   LABS: CT head essentially WNL.  EKG & CXR WNL.  LP revealed CSF w/protein 54 (H).  EMG/NCS c/w inflammatory demyelinating polyneuropathy.	UNK	UNK	lisinopril, hydrochlorothiazide, ASA, simvastin, metamucil, glipizide XL 2.5, metformin 850 a.m. and 1700 p.m	URI	PAST MEDICAL HISTORY: 1.  Diabetes mellitus type 2. 2.  Microalbuminuria and diabetic retinopathy. 3.  Dyslipidemia. 4.  Hypertension. 5.  Gout. 6.  Venous insufficiency, resulting in chronic leg edema and stasis dermatitis. 7.  Colon polyp. 8.  Diverticulosis. 9.  History of pneumonia, left upper lobe. 10.  History of asbestos exposure. 11. Retinopathy			1						1	Albuminuria; Asthenia; Balance disorder; Blood glucose increased; Computerised tomogram abnormal; Full blood count; Gait disturbance; Glycosylated haemoglobin increased; Haematocrit decreased; Haemoglobin decreased; Hypoaesthesia; Immunoglobulins; Laboratory test; Laboratory test normal; Lipids normal; Microalbuminuria; Neutrophil count increased; Paraesthesia; Platelet disorder; Red blood cell sedimentation rate increased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA321CA~6~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0301600	01/03/2008	MA	50.0	50		F	01/03/2008	5 days after flu shot: fever 101+ for 14 days; severe inflammatory headache for 8 days.				Y					Y	11/05/2007	11/10/2007	5	blood and urine tests all normal (no white cell count changes); chest x-ray normal	UNK	UNK						1						1	Blood test normal; Chest X-ray; Headache; Pyrexia; Urine analysis normal	FLUX~UNKNOWN MANUFACTURER~DK~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0301601	01/03/2008	MO	28.0	28		F	12/18/2007	Hives and body ache X2 days, Benadryl.									Y	12/03/2007	12/04/2007	1		UNK	UNK	Loestrine 24Fe	None	None		MO200801	1						1	Pain; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79897~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0301603	01/03/2008	NV	34.0	34		M	01/03/2008	Acute pericarditis onset 10 Dec 07, Direct hyperbilirubinema with transaminitis onset 20 Dec 07 (appx)- failed Motrin, responding to colchicine and Dilaudid. 2/14/08 Reviewed medical records which reveal patient experienced substernal chest pain radiating to bilateral arms & abdomen, nausea, sleep disturbance. Admitted 12/10-12/12/2007.   FINAL DX: Pericarditis. Exam revealed pleuritis & HA.  Dx w/pericarditis.  Tx w/antiinflammatories & improved.  D/C to cardio clinic f/u.   4/11/08 Reviewed hospital medical records of 12/31/2007-1/7/2008. FINAL DX: acute pericarditis; mycoplasma pneumonia; epididymo-orchitis (resolved); allergic rhinitis; GERD; abdominal pain & diarrhea secondary to colchicine. Records reveal patient experienced recurrent chest pain increased w/cough or lying down, DOE, tenderness to chest wall.  Cardio, ID consults done.   Improved & d/c to home.					Y	11			U	12/03/2007	12/10/2007	7	Echo - small pericard effusion, ID labs pending  12/10-12/12/2007 LABS: EKG w/ST elevations.  CK 252 (H), CK-MB 1.7.  Troponin I 0.04 (N)  ESR 3.  Cardiac stress test WNL.  CBC & chemistry WNL.  12/31/2007-01/07/2008 LABS: EKG w/inverted T-waves in all leads.  Echocardiogram revealed new pericardial effusion. ESR 23 (H).  LFTs elevated.  WBC 16.1 (H), plts 467K (H).  CT of chest revealed bilateral pleural effusions.	MIL	MIL	No	No	None  PMH: hiatal hernia, GERD, tobacco user, pleurisy w/chest pain 1 yr prior.  Family hx of CAD			1						1	Electrocardiogram abnormal; Hyperbilirubinaemia; Pericarditis	ANTH~EMERGENT BIOSOLUTIONS~FAV158~6~IM~UN~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500476P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TYP~SANOFI PASTEUR~A02212~6~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Hospitalisation	Influenza
0301604	01/03/2008	MD	33.0	33		F	01/03/2008	Her arm was very sore, got large lump in armpit area, arm got red.  Occured the evening of the injection.  Put warm compresses on it.									Y	11/07/2007	11/07/2007	0		UNK	UNK	Efexor, Valtarin	no	none			1						1	Axillary mass; Erythema; Pain in extremity	FLU3~SANOFI PASTEUR~U2497AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0301606	01/03/2008	SC	58.0	58		F	01/03/2008	Patient states her left upper arm is swollen and sore.  No redness, heat, or skin breaks.  Denies any other symptoms.  She has not sought medical treatment.									Y	12/05/2007	12/05/2007	0	NONE.	UNK	UNK	Zetia; Prozac; Lisinopril; Metformin	NONE	HTN, Hypercholesterol, NIDDM, Depression, Post traumatic stress disorder		SC0726	1						1	Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2501AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U1820GA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0301607	01/03/2008	SC	4.0	4		F	01/03/2008	Child received 4 year old vaccinations on 12/6/2007.  That evening her left arm became swollen, hard, red, and hot. No fever.  Her mother called family MD, who told her to put warm compress on area.  On 12/7/07 her arm did not improve.  No further symptoms.  Mom took her to local hospital ER.  MD evaluated child, stated she had a local allergic reaction.  Benadryl was given.  Mom told that child should not receive vaccines again.				Y					N	12/06/2007	12/06/2007	0	NONE	UNK	UNK	NONE	NONE	NONE		SC0726	1						1	Hypersensitivity; Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B061AA~5~IM~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~02527AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0273~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0287U~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1470U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0301608	01/03/2008	TX	60.0	60		F	01/03/2008	Before Nov. 3 I was a very healthy 60 year old, jogging 3 1/2 miles, 6 days a week, yoga 5 days, excellent diet, correct weight, and on no medications.  Five days after flu vaccination, I began experiencing symptoms.  They have lasted 2 months, and I just now feel that I am getting better.  Symptoms: difficulty breathing, extreme fatigue, extreme weakness in arms and legs, chest pressure and numbness, headaches, dizzy.  These symptoms increased in intensity for 4 weeks, at which time I was admitted to the ER and hospital, and they thought I was having a heart attack or stroke.  In a weeks time I was admitted to the ER 3 times, and each time to the hospital for 1 or 2 days.  All tests ruled out a heart event or clot in lung, many tests were done, and all negative.  The spells that included all the above symptoms, lasted anywhere between 4 hours to 24 hour events, and then a slight reduction in the symptoms for a period of time, and then it would all start again.  The doctors in the hospital were puzzled, and I would tell each one that I recently had the flu vaccine.  They didn't know what was going on.  And they all denied that these would be reactions from the flu vaccine.  Well, I think they are wrong.  I have been doing my own research.  The preservatives used in this particular flu vaccine is Thimerosal (mercury), and I have read about problems with that.  This is only the second flu vaccine that I have had in my life, the last one 18 years ago, no problem that I remember.  And I do know that I will never get another one!  1/15/08 Reviewed hospital medical records which reveal patient experienced chest discomfort, fatigue & SOB x 3 wks.  Admitted 12/6-12/8/07.  D/C to home on antibiotics & urology f/u FINAL DX: ureteropelvic junction obstruction; hydronephrosis; cysto w/right double-J stent placement.  1/24/08 Received email from patient that she was seen by neurologist on 1/23/08 & dx w/severe reaction from flu vaccine which may have triggered a cascade of reactions due to a previously undiagnosed autoimmune disease.  2/1/08 Received neuro office note of 1/15/08 which reveals patient experienced fatigue, lassitude, disequilibrium, dizziness & paresthesias.  Neuro exam was WNL but was referred for MRI of head & c-spine as well as rheumatological labs & paraneoplastic labs to r/o other concerns. FINAL Neuro DX: possible connective tissue disorder or anxiety/panic disorder.  2/19/08 Reviewed hospital medical records which reveal patient experienced chest pain.  Hospitalized on 12/3 but signed out AMA.  Returned after having chest tightness, fatigue & SOB at home.  Admitted 12/4-12/5/2007.  Cardiac consult done. FINAL DX: Atypical chest pain. Follow-up: Along with the other symptoms previously listed, I am now also experiencing: Tingling hands, feet and face. Earaches. Occasional shooting pain in arms and legs. Numbness, chest. Occasional difficulty swallowing. Twitching mostly in arms. Waking gasping for air. Some neurological events, like difficulty typing and putting sentences together. Severe chills. Have an appointment with a neurologist on Tuesday. I had one more visit to the ER last week, with breathing difficulties, and the increase of the intensity of all the symptoms. This is all very frightening, I need help.				Y	Y	4			Y	11/03/2007	11/08/2007	5	CT scans, stress test, every blood test known to human kind!  LABS: CT scan revealed right hydronephrosis (prior hx of same 18 yrs ago).  EKG & cardiac enzymes WNL. CBC, chemistry & UA WNL.  D-Dimer 3.00 (H).  V-Q scan essentially WNL.  Cardiac stress test WNL.  Cardiolite test revealed ejection fx of 61%.  CBC revealed neutros 82.4% (H), lymphs 12.6 (L).  UA WNL, c/s neg.	UNK	UNK	none	none	hydronephrosis of right kidney   upj obstruction  PMH: breast cancer w/left mastectomy 16 yrs ago, hypothyroidism, hydronephrosis, SOB.  Dx w/possible SLE approx 30 yrs ago but never had any treatment & symptoms abated.  Ex-smoker.  Family hx of CAD.			1						1	Anxiety; Cardiac stress test; Chest discomfort; Chills; Connective tissue disorder; Dizziness; Dysphagia; Dyspnoea; Ear pain; Electrocardiogram normal; Fatigue; Fibrin D dimer; Headache; Hypoaesthesia; Laboratory test; Muscular weakness; No reaction on previous exposure to drug; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79238~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0301610	01/03/2008	VA	55.0	55		F	01/03/2008	Within 1 to 2 days client had edema of her fingers on both hands with stiffness. Especially noticed the stiffness at night and when she needs to remove her rings. When see saw her doctor for a physical she mentioned this to the doctor. The doctor ran blood work and it all returned normal.									N	10/15/2007	10/17/2007	2		UNK	UNK	NA	NONE	NONE			1						1	Blood test normal; Musculoskeletal stiffness; Oedema peripheral; Musculoskeletal stiffness; Oedema peripheral	FLU3~SANOFI PASTEUR~U2516AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2516AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0301623	01/03/2008	FL	57.0	57		F	11/30/2007	? Guillain-Barre Syndrome (admitting diagnosis) - Bilateral facial weakness (shortly after receiving flu vaccine) which progressed to numbness/weakness in extremities - received plasmaphoresis - discharged to rehab. 4/21/08-records received for DOS 11/14-11/23/07-DC DX: Hypothyroidism. Cervical disc degeneration/displacement. Bell's palsy. Hypertension. Leukocytosis. Admitted with generalized weakness with numbness and tingling and neurologic dysfunction. Chief complaint of facial weakness, dysphagia and odynophagia.					Y	9			U	11/01/2007	11/15/2007	14	Spinal tap negative; Heavy metals negative; Lyme IgG negative 4/21/08-record received-WBC elevated 18.5, neutrophil % elevated 69.5, lymphocyte % decreased 20.9, sodium decreased 134, blood glucose increased 128.  Lumbar puncture protein 44 and glucose 84. MRI disc disease in cervical spine.	UNK	UNK		None	None 4/21/08-record received-PMH: hypothyroidism.			1						1	Blood heavy metal normal; Borrelia burgdorferi serology; Facial paresis; Hypoaesthesia; Lumbar puncture; Muscular weakness; Plasmapheresis	FLUX~UNKNOWN MANUFACTURER~~1~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0301625	01/03/2008	AK	14.0	14		M	01/03/2008	Immunization record incomplete.  Received vaccines on 11/8/07.  Right testicle became swollen (3 x normal size) and painful with difficulty walking 10 to 12 days post vaccine.  Treated with ibuprofen, warm compresses, and rest.  Seen by pediatrician and urologist about a week later.  Ultrasound of testicle was negative.  Swelling had subsided.				Y					Y	11/08/2007	11/20/2007	12	Ultrasound of testicle - normal	PUB	PUB	None	None	None			1						1	Gait disturbance; Pain; Testicular swelling; Ultrasound scan normal	FLU3~SANOFI PASTEUR~U2443AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1000F~2~UN~RA~HEP B (FOREIGN)~1|MMR~MERCK & CO. INC.~0425U~2~UN~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|MNQ~SANOFI PASTEUR~U2537AA~UNK~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0301627	01/03/2008	IL	4.0			M		Patient returned to clinic with mother.  Right leg swelling to upper thigh and red.  Slightly cool to touch.									N				None	PUB	PUB	None	None	None			1						1	Erythema; Oedema peripheral	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B065AA~2~IM~UN~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80956~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|MMR~MERCK & CO. INC.~0288U~2~~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B54015H~2~IM~UN~PNEUMO (PREVNAR)~1	USA		Influenza
0301637	01/03/2008	FL	1.33	1	.4	F	01/02/2008	< 24 hr after vaccine. Pt developed urticaria. Given Zyrtec, Orapred. Given pedi epipen to have at home.									U	12/27/2007	12/28/2007	1		PVT	PVT		None	H/O UTI/pneumonia. Bartholin abscess			1						1	Urticaria	FLU3~SANOFI PASTEUR~UT24600A~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0301638	01/03/2008	NJ	70.0	70		F	01/02/2008	Pain and reduced ROM (R) deltoid S/P flu shot. No palpable nodule.									N	11/01/2007	11/01/2007	0	None	PUB	OTH	None	N/A	Tics, Pneumonia, Increased lipids			1						1	Injected limb mobility decreased; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0301642	01/03/2008	AL	0.7	0	.7	F	12/21/2007	Sunday 12/16 pm-patient started spitting up after taking bottle pt. became limp-unresponsive-EMS were called and they thought possible seizure-Mom reports unresponsive x 30 minutes no apnea. No color change. Had choking episode before unresponsive (+) congestion, cough-EMS did not take to ER a fever in 2 days were o-Man brought back to clinic on 12/18/07				Y					Y	12/13/2007	12/16/2007	3	8mg old with possible febrile seizure, EEG scheduled for 1/10/08/Examined by DR	PVT	PUB	None		28 wk preemie ventilated at birth			1						1	Choking; Cough; Electroencephalogram; Hypotonia; Infantile spitting up; Respiratory tract congestion; Unresponsive to stimuli	DTAP~SANOFI PASTEUR~U2354BA~3~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT2473HA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B70143A~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0301685	01/04/2008	MI	17.0	17		M	01/04/2008	Patient was given the Pediarix combination vaccine (dtap,hep b,ipv).  This vaccine is not recommended for his age group.  Patient should have received tdap,hep b,ipv.  Per CDC, and Glaxosmithkline no known adverse effects and patient does not need to be revaccinated.									Y	12/27/2007	01/03/2008	7		UNK	UNK			history of neurofibromatosis			1						1	Inappropriate schedule of drug administration; Medication error; Wrong drug administered	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B129AA~1~IM~LA~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2379BA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB217AA~2~IM~LA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2418AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~1364U~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0301694	01/04/2008	WI	38.0	38		F	01/04/2008	12/6/2007 9:00 AM Client reported Lt arm swollen, sore and red at injection site and moving toward armpit.  Site warm to the touch.  She was started on an antibotic and Benadryl. Immunization history flu 02/18/2005, pneumo 10/26/2004 & Td 12/09/1986.									Y	12/04/2007	12/06/2007	2		UNK	UNK	unknown	No	unknown			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2511AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0881F~3~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~UNKNOWN MANUFACTURER~TD157~UNK~IM~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0301740	01/04/2008	CT	0.9	0	.9	F	01/02/2008	Urticaria to all body on next day after administration of Fluzone vaccine.									U	12/27/2007	12/28/2007	1	None	PVT	UNK	Amoxicillin	Otitis media	None			1						1	Urticaria	FLU3~SANOFI PASTEUR~UT2400EA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0301742	01/04/2008	NJ	13.0	13		M	01/04/2008	48 hours after vaccine pt started with erythema multiforme over entire body, but shot site without reaction.  After 5 dys still with scattered hives (previous no egg allergy).				Y					Y	12/26/2007	12/28/2007	2	Lyme titer negative; WBC 12.8, HgB 15.9, HCT 45.2, platelets 378, N 69, M 8, L 20, E 1.7	PVT	PVT	Flovent, Zyrtec	None	Celiac disease, asthma-stable			1						1	Borrelia burgdorferi serology negative; Eosinophil count normal; Erythema multiforme; Haematocrit normal; Haemoglobin normal; Laboratory test; Lymphocyte count normal; Monocyte count normal; Neutrophil count normal; Platelet count normal; Urticaria; White blood cell count increased	FLU3~SANOFI PASTEUR~U2531AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0301747	01/04/2008	IL	1.0	1	.0	M	12/10/2007	Injection site was erythematous.  On 11/11 worsened, became indurated.  On exam had an eryth patch 1.9 x 4.8 cm with slight induration.  Rx ibuprofen, Elacon.  No fever, no drainage.				Y					Y	11/02/2007	11/02/2007	0		PVT	PVT	None	None	None			1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U2438AA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B54007H~4~UN~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0835U~1~UN~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0301748	01/04/2008	MI	0.7	0	.6	F	01/04/2008	Had influenza vaccine #2 on 1/2/08.  Later that day possible seizure.  To ER, temp 104, diagnosed with UTI, not admitted.				Y					Y	01/02/2008	01/02/2008	0		PVT	PVT	None	None	Healthy 6 month-old infant with no significant Hx.			1						1	Convulsion; Pyrexia; Urinary tract infection	FLU3~SANOFI PASTEUR~UT2460YA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0301749	01/04/2008	MD	81.0	81		M		A few days after receiving the flu vaccine, patient bumped his thigh on the edge of a glass table.  It was not sore to touch but ached near the bone.  Dr. said that perhaps it was a 'bone bruise' resulting in a bursitis.  A day later, the pain also involved the hip and got progressively worse.  On 11/6/07 an office visit with Dr.  Perhaps the bone bruise provided a weakened area for the virus to multiply.  Ten days after the flu vaccine was administered, the Zostavax injection was given at the doctor's office.  10/29/07 received flu shot from health dept.  11/6/07 office visit with Dr. because of pain in left hip.  Diagnosis; mild arthritis.  Lipid panel blood test ordered.  Physical therapy ordered.  Rx: ibuprofen 600 mg 3 times daily.  11/9/07 received Zostavax injection at Dr. office.  11/9, 13 and 16/07 physical therapy as ordered by doctor.  Therapist baffled since physical observation is not usual for arthritis.  11/21/07 office visit: pain from left hip moves to include right hip.  No reduction in severity.  Rx: 2 ibuprofen 600 mg and 1 Tylenol 3x's daily.  Dr. ordered blood work that MD (family friend) suggested; sed rate, complete blood count, CPK, rheumatoid arthritis, antinuclear antibody, Lyme titer.  11/21/07 sed rate 99.  11/22/07 (Thanksgiving Day) black stools.  Stopped ibuprofen myself.  Severe pain in upper abdomen/chest area.  Couldn't finish dinner.  Went to bed (head of bed elevated).  Pain continued for several hours.  11/23/07 Office visit with associate MD.  Diagnosis: polymylasia rheumatica.  Stopped ibuprofen and Tylenol.  Prescribed Prednisone 5 mg 3 tablets daily.  Aciphex 1 tablet daily at breakfast.  Ordered blood test.  Called few hours later to say that blood count was up slightly from previous test on 11/6.  Apparently no more bleeding.  11/23/07 bone density X-ray.  11/26/07 Prednisone increased to 10 mg twice daily.  11/27/07 sed rate 56.  Complains of pain in hips and burning in the upper leg; the same sensation experienced with 'shingles'.  12/06/07 sed rate 84.  12/07/07 upper endoscopy (gastroscopy) by Dr. who also ordered blood test and stool OB 3x.  12/21/07 office visit rheumatologist.  12/22/07 sed rate 26.									U	10/29/2007	11/04/2007	6	glucose, 93, 11/06/07; BUN, 19, 11/06/07; sodium, 141, 11/06/07; potassium, 5.0, 11/06/07; chloride, 103, 11/06/07; carbon dioxide, 29, 11/06/07; creatinine, 1.0, 11/06/07; est glomerular filtration rate >60, 11/06/07; eGFR, if African-American, >60, 11/06/07; calcium, 8.6, 11/06/07; total bilirubin, 0.4, 11/06/07; total protein, 6.9, 11/06/07; albumin, 3.2, 11/06/07; alk. phosp, 109, 11/06/07; AST (SGOT), 21, 11/06/07; ALT (SGPT), 42, 11/06/07; cholesterol, 180, 11/06/07; triglycerides, 60, 11/06/07; anion gap, 9.0, 11/06/07; globulin, 3.7, 11/06/07; ALB/GLOB ratio, 0.9, 11/06/07; HDL cholesterol, 49, 11/06/07; LDL cholesterol, 119, 11/06/07; CHOL/HDL ratio, 3.7, 11/06/07; creatine kinase, 66, 11/21/07; white blood cell count, 9.3, 11/21/07; red count, 3.69, 11/21/07; hemoglobin, 11.0, 11/21/07; hematocrit, 32.9, 11/21/07; MCV, 89.3, 11/21/07; MCH, 29.8, 11/21/07; MCHC, 33.3, 11/21/07; platelet count, 399, 11/21/07; RDW, 11.7, 11/21/07; MPV, 7.5, 11/21/07; neutrophils, 70.1, 11/21/07; lymphocyte, 17.6, 11/21/07; monocyte, 9.57, 11/21/07; eosinophil, 2.01, 11/21/07; basophil, 0.65, 11/21/07; sed rate, 99, 11/21/07; rheumatoid factor screen, negative, 11/23/07; antinuclear antibody screen, negative at 1:40, 11/23/07; Lyme Ab, total (IgG/IgM), 2, 11/23/07; bone density scan, imaging of the lumbar spine demonstrates a total BMC of 1.314 with a T-score of 0.8, imaging of both hips demonstrates a total BMD of 1.129 with a T-score of 0.2, 11/23/07; sed rate, 56, 11/27/07; chest X-ray, no active disease, COPD, 12/06/07; white blood cell count, 11.9, 12/06/07; red count 4.12, 12/06/07; hemoglobin, 11.7, 12/06/07; hematocrit, 38.1, 12/06/07; MCV, 92.3, 12/06/07; MCH, 28.3, 12/06/07, MCHC, 30.6, 12/06/07, platelet count, 376, 12/06/07; RDW, 12.3, 12/06/07; MPV, 7.2, 12/06/07; neutrophils, 89.3, 12/06/07; lymphocyte, 5.94, 12/06/07; monocyte, 4.37, 12/06/07; eosinophil, 0.31, 12/06/07; basophil, 0.09, 12/06/07; sed rate 84, 12/06/07; EGD with biopsy, duodenum appeared normal, there was evidence of mild gastritis of the antrum and the body of the stomach, there was a large hiatal hernia, there was evidence of Grade I esophagitis of the esophagus, the mucosa appeared erythematous, a few biopsies were obtained from the distal esophagus, 12/07/2007; white blood cell count, 11.6, 12/17/07; red count 4.13, 12/17/07; hemoglobin, 12.7, 12/17/07; hematocrit, 38.3, 12/17/07; MCV, 92.7, 12/17/07; MCH, 30.7, 12/17/07; MCHC, 33.2, 12/17/07, platelet count, 242, 12/17/07; RDW, 13.3, 12/17/07; MPV, 7.1, 12/17/07; neutrophils, 86.5, 12/17/07; lymphocyte, 9.59, 12/17/07; monocyte, 3.39, 12/17/07; eosinophil, 0.44, 12/17/07; basophil, 0.11, 12/17/07; stool-occult blood, negative, 12/17/07; SED, 26, 12/22/07	PUB	PUB		None	None			1						1	Alanine aminotransferase normal; Albumin globulin ratio decreased; Anion gap normal; Antinuclear antibody negative; Arthralgia; Arthritis; Aspartate aminotransferase normal; Basophil percentage; Biopsy oesophagus; Blood albumin decreased; Blood alkaline phosphatase normal; Blood bilirubin normal; Blood calcium normal; Blood chloride normal; Blood cholesterol normal; Blood creatine phosphokinase normal; Blood creatinine normal; Blood glucose normal; Blood immunoglobulin G normal; Blood immunoglobulin M; Blood potassium normal; Blood sodium normal; Blood triglycerides normal; Blood urea normal; Bone densitometry; Bone pain; Burning sensation; Bursitis; Carbon dioxide normal; Chest X-ray; Chest pain; Chronic obstructive pulmonary disease; Contusion; Culture stool negative; Eosinophil percentage; Eosinophil percentage increased; Faeces discoloured; Gastritis; Globulin; Glomerular filtration rate normal; Haematocrit decreased; Haematocrit normal; Haemoglobin decreased; Haemoglobin normal; Hiatus hernia; High density lipoprotein; Injury; Low density lipoprotein; Lymphocyte percentage; Lymphocyte percentage decreased; Mean cell haemoglobin concentration decreased; Mean cell haemoglobin concentration normal; Mean cell haemoglobin normal; Mean cell volume normal; Mean platelet volume normal; Monocyte percentage; Neutrophil percentage; Neutrophil percentage increased; Occult blood negative; Oesophagitis; Oesophagogastroduodenoscopy; Physiotherapy; Platelet count normal; Polymyalgia rheumatica; Protein total normal; Red blood cell count decreased; Red blood cell count normal; Red blood cell sedimentation rate increased; Red cell distribution width decreased; Red cell distribution width increased; Red cell distribution width normal; Rheumatoid factor negative; Total cholesterol/HDL ratio normal; White blood cell count increased; White blood cell count normal	FLU3~SANOFI PASTEUR~U2448AA~7+~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0301753	01/04/2008	OH	73.0	73		F	01/04/2008	Weak tender muscles in both arms and legs starting after injection and she had difficulty lifting injected arm above head.  She went to her family doctor and received several blood tests and MD started her on an Antibiotic.  Patient said weakness in non- injection arm is starting to go away in last part of December.									U	10/16/2007	10/17/2007	1	MD did blood tests-contact Md for more information.	UNK	UNK	Blood pressure medication	No known illness.	None			1						1	Blood test; Hypokinesia; Injected limb mobility decreased; Muscular weakness; Tenderness	FLU3~SANOFI PASTEUR~U2465AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0301755	01/04/2008	TX	50.0	50		M	01/04/2008	PT. RETURNED TO CLINIC ON 1-2-08 AND REPORTED REDNESS AT SITE OF PNEUMOCOCCAL INJ. LEFT ARM. SITE HAD AREA OF REDNESS AND EDEMA PRESENT MEASURING 115MM X 115MM. PT. DID NOT REPORT ANY OTHER S/S.									Y	12/31/2007	01/01/2008	1	N/A	UNK	UNK	COZAAR, DOXYCYCLINE, FLONASE, ASA	N/A	UNKNOWN			1						1	Injection site erythema; Injection site oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA312BA~3~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|IPV~SANOFI PASTEUR~AO2732~2~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|PPV~MERCK & CO. INC.~1132U~1~SC~LA~PNEUMO (PNEUMOVAX)~1|TYP~SANOFI PASTEUR~AO3942~2~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0301761	01/05/2008	NJ	24.0	24		F	01/05/2008	Member received Twinrix, ppd, and flu mist on 8 December 2007. A couple of days later patient C/O rash on face, neck, and upper body. Rash lasted 7 to 10 days.									Y	12/08/2007	12/12/2007	4	none	MIL	MIL	none	none				1						1	Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500502P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB091CA~2~IM~RA~HEP A + HEP B (TWINRIX)~1	USA		Influenza
0301771	01/07/2008	NC	11.0	11		M	01/02/2008	Localized erythema and induration at site of injection of Varivax.				Y					U	12/31/2007	01/01/2008	1		PVT	PUB		N/A	N/A			1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U2446AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB225BB~1~IM~LA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2542AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~1331U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0301772	01/07/2008	NC	11.0	11		M	01/02/2008	Localized reaction at site of injection with erythema and induration secondary to Varivax.				Y					U	12/31/2007	01/01/2008	1		PVT	PUB	N/A	N/A	N/A			1						1	Injection site erythema; Injection site induration; Injection site reaction	FLU3~SANOFI PASTEUR~U2446AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB225BB~1~IM~LA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2542AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~1331U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0301777	01/07/2008	MI	1.1	1	.1	M	01/03/2008	Child given 4th dose of IPV at shot appointment.  Child did not need this dose of vaccine.									Y	01/02/2008				PUB	PUB	None	Runny clear nose	None			1						1	Accidental overdose; Inappropriate schedule of drug administration; Medication error	FLU3~SANOFI PASTEUR~UT2477DA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB171AA~1~IM~LL~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~A02732~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0749U~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~854013C~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1495U~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0301780	01/07/2008	OH	3.0	3		M	01/04/2007	Patient had a 6 by 3 in reaction.  Very red, swollen and hot to touch.  No other symptoms were noted.				Y					Y	01/03/2007	01/03/2007	0	None	PVT	PVT	None	None	None			1						1	Erythema; Skin warm; Swelling	DTAP~SANOFI PASTEUR~C2800AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2526AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0273~4~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~0774U~2~SC~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0301793	01/07/2008	VT	30.0	30		M	01/07/2008	Received Flu shot on November 15, 2007. Developed fever that night. On November 16, had fever and generalized muscle soreness, most pronounced in shoulders. November 17 and 18: progressive loss of strength and motor function in the hands, fatigue, continued fever and increasing muscle soreness. November 18th: fever resolved, but saw physician at clinic for continued soreness, fatigue, and loss of motor function in the hands. Referred to Neurology on November 20. Diagnosed with Parsonage-Turner Syndrome (acute brachial neuritis). Motor function in hands resolved without treatment within 2 weeks following visit with Dr., with minor residual weakness.  Fatigue continued to present.  01/18/2008 MR received for Clinic visits 11/18/07 and 1/02/2008. Pt c/o fever, bil hand pain initially then hips and ankles, and muscle weakness.  Weakness to hands (L>R) noted on PE. Reflexes 1+ in upper extremities, 2+ lower. Seen by neurology 11/20/07 for EMG and NCS DX: Acute Brachial Neuritis. Seen again 01/02/08 with fatigue and nausea since visit in Nov.  Exam WNL.  Impression: Nausea, Possible GERD, Fatigue				Y					N	11/15/2007	11/16/2007	1	Neurological exam on November 20, 2007 revealed normal tendon reflexes in the legs, diminished in arms. Electric reflex stimulation demonstrated conduction velocities in normal range. Clinical exam demonstrated complete loss of resistance to pull in distal flexors of left thumb and first 2 fingers, weakness on right side.  Labs and Diagnostics:  EMG and NCS 11/20/07  normal.  H.pylori (-). CBC, UA and Chem WNL.	UNK	UNK	none	none	none. PMH: Mono (remote) and pneumonia.			1						1	Asthenia; Fatigue; Muscular weakness; Myalgia; Neuralgic amyotrophy; Neurological examination abnormal; Pyrexia; Radiculitis brachial	FLU3~SANOFI PASTEUR~U2529AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0301797	01/07/2008	CA	22.0	22		F	01/07/2008	PATIENT WAS UNAWARE SHE WAS PREGNANT AT TIME OF FLU MIST ADMINISTRATION. AFTERWARDS SHE FOUND OUT SHE WAS PREGNANT.  IT APPEARS SHE WAS APPROXIMATELY 4 WKS PREGNANT AT TIME OF ADMINISTRATION.  PATIENT IS NOW EXPERIENCING THREATENED ABORTION. SHE HAS BEEN BLEEDING AND CRAMPING FOR LAST SEVERAL WEEKS.  THERE IS STILL FETAL HEART SOUNDS, BUT PER OB-GYN ER NOTE, APPEARED TO BE TISSUE PROTRUDING FROM CERVICAL OS.				Y					U	12/07/2007	12/28/2007	21	B-HCG LOW FOR GESTATIONAL AGE. NO DEFINITE FETAL POLE SEEN ON ULTRASOUND AS OF YET. MEAN GESTATIONAL SAC SIZE 15 MM, JUST BELOW DISCRIMINATORY LEVEL OF 16 MM.	MIL	MIL		NONE	NONE			1						1	Abortion threatened; Blood gonadotrophin decreased; Drug exposure during pregnancy; Ultrasound scan	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0301798	01/07/2008	CA	46.0	46		F	01/07/2008	Pain at site of injection has not gone away. Pain in deltoid area when lifts arm over head.									U	10/05/2007	10/05/2007	0	1-07-08, seen at facility.  No labs or x-rays taken.  Diagnosed as soft tissue injury.	UNK	UNK			Insulin Dependent Diabetes			1						1	Injection site pain; Soft tissue injury	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA298AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301801	01/07/2008	IL	3.0	3		M	01/07/2008	3yr.4month h/m received flu vaccine prior in 01/06/06 and 12/02/05, pt given flu vaccine at 4:30pm and at 4:40pm upon discharge mother noticed child scratching and itching mother brought child back to the nurse and child presented with rash to forhead and a few spots of itching to upper back.  No respiratory symptoms, no whezzing, and no SOB noted. Child alert, pediatrician at the clinic examined the patient and 911 was called for child to go to ER for close observation.  Mother informed Dr. child had eaten eggs and sausage in the morning.  Ambulance came and child left on stable conmdition to go to Hospital.				Y					Y	01/04/2008	01/04/2008	0		UNK	UNK						1						1	Pruritus; Rash; Scratch	FLU3~SANOFI PASTEUR~U2487AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0301807	01/07/2008	FL	0.64	0	.6	F		Stroke vs acute disseminated Encephalomyelitis.  1/8/08 Received vax record which confirms Aventis flu vaccine given 12/11. 1/8/08 Reviewed hospital medical records which reveal patient experienced right facial & RUE paresis x 2 days starting 2 hours s/p flu shot.  Seen in ER on 12/12, diagnosed w/weakness & d/c to home. No improvement.  Admitted 12/13-12-15/2007 to PICU.  Neuro consult done. FINAL DX: stroke, left basal ganglia infarct. 01/11/2008 Received additional hospital medical records which reveal patient experienced suspected ADEM vs stroke syndrome.  Admitted to PICU 12/21-12/23/2007.  Neuro consult done & tx w/high dose steroids.  Stable & d/c to home on continued steroids & neuro f/u. FINAL DX: none provided on d/c summary except ADEM vs stroke syndrome.  Neuro consult dx stroke.					Y	3				12/11/2007	12/11/2007	0	MRI, LP LABS 12/13-15/2007: Multiple MRIs revealed worsening infarct in left basal ganglia & adjacent white matter. MRA of brain WNL.  Echocardiogram showed small PDA. LABS 12/21-23/2007: CSF glucose 46 (N), protein 28.9 (N), culture neg.  EEG WNL.	PVT	PUB	None	None	None PMH: allergy amoxicillin.  C-section, uncomplicated birth.		FL2008001	1						1	Cerebrovascular accident; Lumbar puncture	FLU3~SANOFI PASTEUR~U2481GA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0301812	01/07/2008	TN	3.0	3		M	01/07/2008	Urticarial swelling on left cheek.									Y	10/08/2007	10/08/2007	0	None	PVT	UNK	None	None	Peanut allergy, dog and grass allergy, egg allergy			1						1	Swelling; Urticaria	FLU3~SANOFI PASTEUR~U2457EA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0797U~2~IM~LL~HEP A (VAQTA)~1	USA		Influenza
0301815	01/07/2008	NC	76.0	76		M	12/30/2007	Had flu shot morning of Oct. 16. Woke me at 2 AM in excruciating pain in his right leg. We went to emergency room. They x-rayed but could not find anything. Went home. Sunday, he was back in pain. We were back in emergency room. X-rayed higher; could not find nothing. Mon. saw his doctor, had MRI - nothing - went to sports doctor and could find nothing. They said to take him to his neurologist. We did, he couldn't find anything wrong with his leg. Some arthritis in hips, and back only. He was on medication for Alzheimer, after this incident he went into full blown Alzheimer and I had to put him into a nursing home December 14, 2007.				Y					N	10/16/2007	10/17/2007	1	None	UNK	UNK		None	Diabetes, High blood pressure, Alzheimer's			1						1	Arthritis; Condition aggravated; Dementia Alzheimer's type; Pain in extremity; X-ray limb normal; X-ray of pelvis and hip normal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79718~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0301817	01/07/2008	OR	1.9	1	.9	M	01/07/2008	Vaccinations on 1-2-08.  Mother calls 1-4-08 to report redness, swelling & hot at L leg (thigh) injection site.  Also reports site turning sort of black.  Instructed mother to take child to his pediatrician today.  1-7-07 follow up with mom: child on cephalexin since 1-4-08 MD visit.  Feeling better.  Leg looks better.  MD records indicate L upper thigh redness around puncture site, redness, and 3 cm induration around puncture site.				Y					Y	01/02/2008	01/04/2008	2		PUB	PUB	None	No	Lactose allergy			1						1	Injection site discolouration; Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth	DTAP~SANOFI PASTEUR~42059AA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2440AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB211A4~2~IM~RL~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0301818	01/07/2008	WA	4.0	4		M	01/07/2008	Received 0.5ml of Fluzone from multidose vial containing preservative Thimerosal. Mother had requested the single-unit dose without Thimerosal. No clinical adverse event.  1/25/08 There was no adverse event from the vaccine.  Mother is concerned that the THIMOROSAL preservative may eventually cause a problem.									U	12/27/2007			None	PVT	UNK		None	None			1						1	Medication error; Wrong drug administered	FLU3~SANOFI PASTEUR~U2524AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0296567	01/08/2008	ID	62.0	62		F	11/30/2007	Client received hep a/b Twinrix #1, Zostavax and flu shots on 11/09/2007.  Clients noted red spots on back arm (l), (l) breast and (r)shoulder and thighs then (l) face and cheek became swollen and upper lip swollen over bottom lip.				Y					U	11/09/2007	11/11/2007	2		UNK	UNK	none know	none	none noted on medical historoy		ID07052	1						2	Erythema; Lip swelling; Rash; Swelling face	FLU3~SANOFI PASTEUR~U250AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB107AA~1~IM~LA~HEP A + HEP B (TWINRIX)~2|VARZOS~MERCK & CO. INC.~0882U~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~2	USA	Emergency room visit	Influenza
0301883	01/08/2008	MI	48.0	48		F	10/03/2007	Painful injection site for 3 days.  Can't sleep.  Going to doctor today.  Dr. told her that shot probably hit a tendon or ligament and gave her some pain pills to use at night.  Still sore 10/6/07.				Y					U	09/29/2007	09/29/2007	0	None known	OTH	PVT		None	None			1						1	Injection site pain; Insomnia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA294EA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0301884	01/08/2008	MI	82.0	82		F	10/15/2007	Administered Fluarix in left arm.  Took needle out and arm began swelling in egg shape, hard mass.  Applied ice pack, gave Benadryl 50 mg capsule.  Swelling was the only sign of adverse reaction.									Y	10/15/2007	10/15/2007	0	None	PUB	OTH		Eye infection	None			1						1	Injection site induration; Injection site mass; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA317AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301885	01/08/2008	OH	74.0	74		F	10/31/2007	Pt reported that arm (left) was sore the evening of vaccine, woke up in the morning, arm at site of vaccine was warm, red, and severely swollen. Pt went to clinic; received diphenhydramine injection and Prednisone taper.				Y					Y	10/11/2007	10/11/2007	0		OTH	PVT	None	None				1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA298AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0749F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0301886	01/08/2008	OH	35.0	35		M	11/14/2007	1st time patient received flu shot.  Itching, redness face, little on top of chest, none on arms/back or body.  BP 153/79, pulse 8.  Gave Benadryl 50 mg, advised q 6 hours x2 days, then see MD.  Gave pt. Benadryl if continues.									Y	11/14/2007	11/14/2007	0	BP 153/79, pulse 80	OTH	PVT	None	None	Codeine allergy			1						1	Blood pressure; Erythema; Heart rate normal; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA319AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301887	01/08/2008	OH	20.0	20		M	11/14/2007	1st time patient received Flu shot. BP 128/71. Pt felt dizzy/shaking, flushed. 5 min recheck BP gave O.J. and crackers. BP 113/74, 85 pulse, felt ok. Gave cold compress. Patient had not eaten upon further conversation.									Y	11/14/2007	11/14/2007	0	BP 128/71, Pulse 105; Recheck 113/74, Pulse 85	OTH	UNK	None	None	NKDA			1						1	Blood pressure; Dizziness; Flushing; Heart rate increased; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA307AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301888	01/08/2008	OH	70.0	70		F	10/28/2007	Bruising, tenderness day after injection; patient reported improvement by 10-27-07.									Y	10/23/2007	10/23/2007	0		OTH	OTH		None				1						1	Contusion; Tenderness	FLU3~SANOFI PASTEUR~U2506AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0301890	01/08/2008	OH	23.0	23		F	11/14/2007	Patient has had flu shot in past.  Hot, sweating, shaking, dizzy.  BP 120/79, pulse 99.  10 min later recheck 125/79, pulse 89.  Cold compress, orange juice, crackers given.									Y	11/14/2007	11/14/2007	0	BP 12/79, pulse 99; recheck 125/79, pulse 89	OTH	PVT		None	Sulfa allergy			1						1	Blood pressure; Dizziness; Feeling hot; Heart rate normal; Hyperhidrosis; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA294EA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301893	01/08/2008	OH	23.0	23		F	11/14/2007	Patient's first time getting flu shot. Patient felt flushed, dizzy, nauseated 5-10 minutes after flu shot. BP 141/93, Pulse 93. Recheck 5 min, 125/83, Pulse 83. Called corporate. Found out patient had not eaten yet, gave crackers, orange juice. Patient felt better. Cold compress applied.									Y	11/14/2007	11/14/2007	0	BP 141/93, Pulse 93; 5 min later 125/83, EMS 110/74	OTH	PVT	None	None	N/A			1						1	Blood pressure increased; Dizziness; Flushing; Heart rate; Heart rate increased; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA294EA~1~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301895	01/08/2008	OH	46.0	46		F	01/02/2008	Patient became lightheaded and remained in chair for 20-30 minutes.  She requested water.  She kept her head lowered to help with lightheadedness.  She reported itching especially on her head.  We gave 50 mg PO Benadryl and symptoms improved in 30-40 min. Her husband took her home.  We made a follow up call to patient early afternoon next day and she said she was fine.									Y	12/29/2007	12/29/2007	0		OTH	PVT		None	None			1						1	Dizziness; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA319BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301896	01/08/2008	MI	59.0	59		F	11/13/2007	Pt said broke out in rash the week of Oct 8th which is the week she got her flu shot. She said she didn't think anything of it but it kept getting itchier and spreading. She finally went to the doctor on 11/6/07. Doctor says that is the only thing they can figure it was from.									U	10/08/2007	10/08/2007	0	None	OTH	OTH		None	Glaucoma, Hypertension, NKDA			1						1	Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA294EA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301898	01/08/2008	OH	53.0	53		F	10/16/2007	Localized swelling in right arm and redness approximately 8 inch diameter following flu shot. Now approximately 6 inches diameter.									Y	10/13/2007	10/13/2007	0		OTH	OTH		No	Grass			1						1	Erythema; Oedema peripheral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA298AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301899	01/08/2008	MI	57.0	57		M	01/02/2008	Patient developed itchy eyes and neck rash 24 to 48 hours after receiving the vaccine. Patient instructed to take OTC Benadryl.									Y	12/29/2007	12/30/2007	1	None	OTH	PVT	None	None	NKA			1						1	Eye pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA319BA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301900	01/08/2008	MI	75.0	75		F	10/02/2007	Patient felt numbness in lower part of legs, started to collapse.									Y	10/02/2007	10/02/2007	0	N/A	PUB	OTH		No	High blood pressure			1						1	Hypoaesthesia; Syncope	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA294EA~1~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301913	01/08/2008	TN	14.0	14		M	01/08/2008	Patient received flu vaccine that was for ages 18yrs and up.  No adverse effects noted while patient was in office. No adverse events reported by parents as of reporting date.									Y	01/04/2008	01/04/2008	0	None performed	UNK	UNK	none reported	patient denied	asthma, seasonal allergies	none known~ ()~~0.00~Patient		1						1	Inappropriate schedule of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA280DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301914	01/08/2008	CA	0.63	0	.6	M	01/08/2008	Received 4 vaccines @ 9:30 AM on 1-7-08. At 10:30 pm fever of 104.4. Mother put baby in tepid bath, gave Tylenol and fever dropped to 101. Continues with 101 fevers @ 24 hrs. later. Referred to Pediatrician. Pediatrician beleives fever from a cold and not related to vaccines.										01/07/2008	01/07/2008	0		UNK	UNK						1						1	Nasopharyngitis; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B069AA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2477BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08702B~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1167F~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0301944	01/08/2008	NE	68.0	68		F	01/08/2008	Patient complains of soreness in shoulder and upper arm, says cannot raise arm above shoulder level, states started with initial soreness in arm at vaccination site (left arm).									U	10/25/2007	10/25/2007	0		UNK	UNK	Hydrochlorothiazide 25mg, Armour thyroid 15mg, Zolpidem 10mg	None reported	Hypothyrodism (treated)			1						1	Injected limb mobility decreased; Injection site pain; Musculoskeletal pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2487AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0301949	01/08/2008	MI	28.0	28		F	10/15/2007	Hospitalized within					Y	5			Y	10/15/2007				PUB	PVT			Allergies - Compazine, Demerol; Diabetes			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U244099~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0691U~1~IM~RA~HEP B (RECOMBIVAX HB)~1|PPV~MERCK & CO. INC.~0881F~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2824AA~1~IM~RA~TDAP (ADACEL)~1	USA	Hospitalisation	Influenza
0301954	01/08/2008	AZ	0.5	0	.5	M	01/07/2008	Given vaccines uneventfully, within 10-15 minutes became slightly listless and sleepy, started with projectile vomiting multiple times, clammy and pale, HR 120, temp decreased to 96.8, well perfused, no respiratory distress.  Patient continued to have vomiting and onset of diarrhea over next 2 hours and sent to ED where recovered without treatment.				Y					Y	01/07/2008	01/07/2008	0	None	PVT	PVT	None	None	None			1						1	Body temperature decreased; Cold sweat; Diarrhoea; Heart rate increased; Listless; Pallor; Somnolence; Vomiting projectile	DTAP~SANOFI PASTEUR~C2765AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2512AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF215AA~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C49922~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1701U~3~~~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0301956	01/08/2008	IN	49.0	49		F	12/19/2007	Evening 12/17/07 itchy, red, swollen, and tender. Benadryl 50 q 8 hours. Then Zyrtec 10 q.d. x 7 days.									Y	12/17/2007	12/17/2007	0	None	PVT	UNK		None	DM, HTN			1						1	Erythema; Pruritus; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U246AA~5~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1416U~2~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0301958	01/08/2008	MA	58.0	58		M	01/08/2008	Starting 11/9/07 experienced multiple site joint pain.  Pain (with swelling) migrates.				Y					N	10/25/2007	11/09/2007	15	Tested for lyme disease and gout.	PVT	PVT	Verapamil, Hydroxyurea		Polycythemia, Hypertension			1						1	Arthralgia; Laboratory test; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AELUU296A~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0301962	01/08/2008	NM	11.0	11		F	01/22/2008	No menses since immunization.  Daily severe headaches accompanied by dizziness.  Headaches started the day of immunization.  Also local rxn-redness, swelling R arm.  Client just started menstruating 8-07.									U	11/16/2007	11/16/2007	0	None	PUB	PUB	Currently on Claritin D & Tylenol	None	None			1						1	Amenorrhoea; Dizziness; Headache; Injection site erythema; Injection site swelling; Local reaction	FLU3~SANOFI PASTEUR~U2515AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB214AA~1~IM~LA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~0929U~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2427AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B015AA~1~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0301971	01/08/2008	TN	4.0	4		F	12/13/2007	Possible secondary infection ie) scratching forearm, itching with vaccinations.  Redness, warmth and 1-2+ swelling of L arm, mid upper arm, elbow, and lower arm (started 12-13-07).  Injection sites not red.  Treatment: 1) ibuprofen 100 mg/5 ml 7.5 ml Q 6-8 hrs., 2) Dephenhist 1-2 tsp. TID.									Y	12/11/2007	12/12/2007	1		PUB	PUB	Glycolax 1 tsp. daily, ranitidine 5mg BID	None	None			1						1	Erythema; Infection; Injection site swelling; Injection site warmth; Pruritus	DTAP~SANOFI PASTEUR~C2607AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2511AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0170~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0301972	01/08/2008	TN	71.0	71		F	12/22/2007	Day 1: 8 p.m. itching, redness under arm; followed by edema to elbow (left arm). Day 2: edema to fingers. Day 3: MRI, Levaquin, Medrol dose pack. Day 6: Severe, sharp, stabbing pain, right thigh, followed by severe circular bruising.				Y					Y	12/03/2007	12/03/2007	0	MRI of arm (L); MRI - r leg and thigh; X-ray of r. thigh.	PVT	UNK	Omeprazole 20 mg; Evista 60 mg; Nadolol 20 mg; Cymbalta 60 mg; Gabpentin 300 mg; Aspirin 81 mg; Multivitamin; Calcium; Omega 3; Acidolphilus; Vitamin E	None				1						1	Contusion; Erythema; Joint swelling; Nuclear magnetic resonance imaging; Oedema peripheral; Pain in extremity; Pruritus; X-ray; Erythema; Oedema peripheral; Ultrasound scan normal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA055AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1384U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~1384U~2~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0301973	01/08/2008	AL	6.0	6		M	01/03/2008	Light rash similar to varicella noted after VCV vaccine given.										12/31/2007	01/02/2008	2		PUB	OTH	None	None	None			1						1	Rash vesicular	FLU3~SANOFI PASTEUR~U2487AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0494U~UNK~IM~LA~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~1101U~UNK~~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0301976	01/08/2008	AK	0.7	0	.7	M	01/04/2008	1/3/08 - Fever within one day of vaccine to 102 degrees.  Mom gave Tylenol, temp decreased to 100.8.  Started runny nose, clear.  Fussy morning after shots.  1/4/08 - Afebrile, not fussy, with decreased appetite.									Y	01/02/2008	01/03/2008	1	None	PVT	PUB	Tylenol	None	None			1						1	Decreased appetite; Irritability; Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~UT2456FA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B08700H~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0301980	01/08/2008	OH	46.0	46		F	01/02/2008	Patient became lightheaded and remained in chair for 20-30 minutes.  She requested water.  She kept her head lowered to help with lightheadedness.  She reported itching especially on her head.  We gave 50mg PO Benadryl and symptoms improved in 30-40 minutes.  Her husband took her home.  We made a follow up call to patient early afternoon next day and she said she was fine.									Y	12/29/2007	12/29/2007	0		OTH	PVT		None	None			1						1	Dizziness; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA319BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0301982	01/08/2008	NH	1.0	1	.0	M	01/02/2008	Erythematous blanching 45 x 4cm, slight induration left thigh with 2 puncture spots; non-tender, not warm.  Right anterior thigh slightly blanching erythema papule at injection site.  Benadryl every 6 hours.  ? allergy to eggs in future.				Y					Y	12/18/2007	12/19/2007	1		PVT	PUB	None	None	S/P hypospadius repair, oral surgery			1						1	Injection site erythema; Injection site induration; Injection site papule; Pallor; Rash erythematous	FLU3~SANOFI PASTEUR~UT2460BA~2~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB21AA~1~~RL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~B54015C~4~~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0301984	01/08/2008	SC	0.7	0	.7	F	12/28/2007	Moaning while sleeping woke her up very high fever over 103.5. Taken to ER, given 2mg Motrin. Fever decreased to 102.9. Gave alternating doses Tylenol/ Motrin every 4 hours. Fever went completely away 24 hrs later.				Y					Y	12/28/2007	12/28/2007	0	None	PUB	OTH		None	None			1						1	Moaning; Pyrexia	DTAPHEPBIP~UNKNOWN MANUFACTURER~~3~UN~UN~DTAP + HEPB + IPV (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~UNKNOWN MANUFACTURER~~3~UN~UN~HIB (NO BRAND NAME)~1|PNC~PFIZER\WYETH~~3~UN~UN~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0301987	01/08/2008	MI	1.3	1	.3	F	12/19/2007	MMR injection given with well child visit, SQ left upper thigh.  Child unable to settle after injection.  Approximately 10 minutes later reddened raised area approx 8 cm x 6 cm.  Benadryl & Tylenol given as per Dr. - cont to assess x30 minutes.  Reaction site reduced greatly in size prior to leaving the office.									Y	12/19/2007	12/19/2007	0		PUB	PUB						1						1	Injection site erythema; Injection site swelling; Restlessness	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B056BA~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2460GA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1003F~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0301989	01/08/2008	IL	66.0			U		Jaw muscles hard to open mouth first thing in morning Nov. 14, 07 - wasn't told about mercury.  Severe aches and pain in all joints, swelling of ankles, can hardly walk in morning, couldn't use arm.  Symptoms ongoing, no strength in hands & arms.  Pain med.									U					UNK	UNK						1						1	Arthralgia; Asthenia; Gait disturbance; Injected limb mobility decreased; Joint stiffness; Joint swelling	FLU3~SANOFI PASTEUR~013287801996~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0302000	01/08/2008	NC	4.0	4		F	12/03/2007	Child was coughing/wheezing, had hives on chest, arms, legs and bottom of neck. Tx was started with 1 3/4 tsp of Benadryl given at 10:05 A followed by Albuterol 0.083% at 10:05. Vitals were HR 129, O2 98%, BP 82/42, R 20. Decadron 8mg given, epinephrine 1/1000, 0.16 mg given SQ. 11:25 rechecked vitals BP 100/54, HR 120, O2 98, temp 98.8, R 22, epinephrine 1/1000 0.16 mg given SQ. 12:25 Vitals rechecked BP 102/52, HR 130, O2 98, temp 98.7, R 26. Pt remained under close observation and was clear to leave office.				Y					Y	12/03/2007	12/03/2007	0	Sending pt to allergist	PVT	PUB						1						1	Cough; Urticaria; Wheezing	DTAP~SANOFI PASTEUR~U2289AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2479BA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB182AA~2~IM~RA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~Z0873~4~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0185U~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1490U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0302001	01/08/2008	KS	24.0	24		F	01/08/2008	Received Influenza and Pneumoccocal Polysaccharide vaccines 01-07-08.  Client reports at 9 pm.  01-07-08 noted redness, swelling, warmth, tenderness of right arm where both shots were given.  Noted 2 areas of erythema, some swelling, warmth upper right arm at injection sites.  Also, reports fever 102.1.  Aches of body.				Y					U	01/07/2008	01/07/2008	0	Unknown	PUB	PVT	Levothyroxine daily	None	Thyroid condition			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pain	FLU3~SANOFI PASTEUR~U2524AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1380U~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0302003	01/08/2008	OH	48.0	48		F	12/31/2007	Patient came to pharmacy on 12/22/2007 to receive flu shot.  Patient contacted pharmacy on 12/27/2007 with report of hives from flu shot.  Patient wasn't initially going to let us know about the reaction, so patient was not upset in any way whatsoever about the reaction.									U	12/22/2007	12/22/2007	0		UNK	UNK						1						1	Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0302004	01/08/2008	MI				F	10/30/2007	The brand Fluzone injection is supposed to be given to individuals under 18 years of age.  A dose of Fluarix prefilled vaccine was given by mistake.  The fluarix is used for the same purpose, it just hasn't been tested for safety yet under 18 years of age.  The patient's mother was not upset, she said her daughter was feeling fine.													None	UNK	UNK			None			1						1	Inappropriate schedule of drug administration; Medication error; Inappropriate schedule of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~6886579~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~6886579~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA		Influenza
0302005	01/08/2008	OH	43.0	43		F	10/22/2007	I was told Monday (10/22/07) morning that a pharmacist may have given a flu shot in a patient's hip rather than in the deltoid.  I looked through the consent forms and found one for patient stating that the shot was administered in the hip.  It is my understanding that the patient insisted she be given the shot in the hip as she could not take in the arm.  No symptoms reported at this time.									U	10/20/2007	10/20/2007	0		UNK	UNK						1						1	Incorrect route of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~GM~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0302006	01/08/2008	OH	86.0	86		F	10/08/2007	Got shot at 11:30AM.  Patient called at 3pm, had low blood pressure and was lightheaded.  118/70, pulse 102, at 3:09, 112/65, pulse 71, 3:33, 128/66, pulse 69, 3:40 118/63, pulse 63.  She's feeling better.  She just asked if this could be a reaction to the flu shot.  I said I'd call MD.  Dr. didn't think low BP could be because of flu shot.  He never heard of that.  I called her at 6PM BP 14/82, pulse 56.  She was feeling better and said I must love my job to put up with customers like her.  She was feeling much better.									Y	10/08/2007	10/08/2007	0		UNK	UNK						1						1	Dizziness; Heart rate; Hypotension	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0286192	01/09/2008	NC	0.51	0	.5	M	01/09/2008	Child passed newborn hearing screen (OAE)--have record documentation. Previously well by report until 6 month well child visit. At that visit child received 4 immunizations, listed below. Of note, Hep B component of the Pediarix vaccine was 4th Heb B shot since child received one at birth as well. No prior adverse reaction. Parent reports temperature elevation to 103-104 range beginning 3 hours after shots and persisting for one week. Also reports stiff neck and what sounds like torticollis with head in position with right ear touching right shoulder. Parent reports placing repeated calls to doctor but receiving only reassurance. Child not admitted to hospital and no labs or tests performed. After one week, fever subsided and child began holding hands to ears and crying. This persisted for next 3-4 months after which child underwent ENT evaluation and hearing test. After tubes were placed for fluid in ears, child was found by audiology and brainstem audiometry to have severe to profound deafness. This has been repeated on a number of tests and patient is now being considered for a cochlear implant. Only a few cases of deafness after immunization have been reported in the literature. Possibility of encephalitis or meningitis exists but cannot be proven since child did not undergo lumbar puncture at the time.								Y	N	01/23/2007	01/23/2007	0	See above. Nothing available except hearing tests which now reveal severe to profound deafness.	MIL	MIL	n/a	None	None	None~ ()~~0.00~Patient|None~ ()~~0.00~Sibling|N/A~ ()~~0.00~Sibling		1						2	Abnormal behaviour; Acoustic stimulation tests abnormal; Audiogram abnormal; Body temperature increased; Brain stem auditory evoked response abnormal; Crying; Deafness; Encephalitis; Meningitis; Musculoskeletal stiffness; Posture abnormal; Pyrexia; Torticollis	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~~4~IN~NS~DTAP + HEPB + IPV (PEDIARIX)~2|FLU3~SANOFI PASTEUR~U0135AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~UNKNOWN MANUFACTURER~~3~IM~UN~HIB (NO BRAND NAME)~2|PNC~PFIZER\WYETH~~1~IM~UN~PNEUMO (PREVNAR)~2	USA	Disabling	Influenza
0293054	01/09/2008	OH	1.25	1	.3	F	01/04/2008	Information has been received from a registered nurse concerning six patients who were vaccinated with Varivax (Oka/Merck). Subsequently, the patients experienced breakthrough chickenpox. A product quality complaint was not involved. Follow-up received 20-SEP-2007: Follow-up information has been received from a registered nurse concerning a 21-month-old female with no pertinent medical history or allergies who on 20-JAN-2007 was vaccinated in her left thigh with her first dose of ProQuad (lot # 656165/1387F). It was unknown if there were any illnesses at the time of vaccination. On 20-JAN-2007 concomitant vaccines included fourth dose of TriHIBit (Sanofi Pasteur) (Lot # V1455AA & VE959AA), a fourth dose of Prevnar (Wyeth) (Lot # B08684A) and first 0.25 mg dose of influenza virus vaccine (unspecified) (Sanofi Pasteur) (Lot # UT2176JA). On 18AUG-2007 the patient developed numerous lesions on her face. The patient was prescribed with ZOVIRAX 200 mg-5 mL three times a day for 5 days. The patient recovered from the adverse event at an unspecified date. The event was considered to be an other important medical event by the reporter. It was noted that the patient's sibling (WAES # 0709USA03345) experienced an adverse event. This is one of several reports from the same source. Additional information has been requested.									Y	01/20/2007	08/18/2007	210	Unknown	PVT	PVT	Unknown		None	Rash vesicular~Varicella (no brand name)~~4.00~Sibling	WAES0708USA05829	1						2	Familial risk factor; Skin lesion; Varicella; Skin lesion; Varicella; Varicella post vaccine	DTAPH~SANOFI PASTEUR~V1465AA~4~UN~UN~DTAP + HIB (TRIHIBIT)~2|FLU3~SANOFI PASTEUR~UT2176JA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|MMRV~MERCK & CO. INC.~1387F~1~UN~UN~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~2|PNC~PFIZER\WYETH~B08684A~4~UN~UN~PNEUMO (PREVNAR)~2|DTAP~SANOFI PASTEUR~V1465AA~4~UN~UN~DTAP (TRIPEDIA)~3|FLU3~SANOFI PASTEUR~UT2176JA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~3|HIBV~SANOFI PASTEUR~VE939AA~4~UN~UN~HIB (ACTHIB)~3|MMRV~MERCK & CO. INC.~1387F~1~UN~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~3|PNC~PFIZER\WYETH~B08684A~4~UN~UN~PNEUMO (PREVNAR)~3	USA		Influenza
0300085	01/09/2008	TX	0.5	0	.5	M		My 7 month old son began vomiting in the evening on Nov. 25th. He threw up a dark brownish substance all night. The morning of Nov. 26, I took him to his pediatrician, he was severely dehydrated and listless. He was hospitalized that afternoon. We were suspecting a viral stomach bug, but after 2 days in the hospital (being given fluids intravenously), he showed no signs of improvement, in fact his condition worsened. He continued to vomit, only holding a few teaspoons of water down over the course of the two days. The doctor and I began to suspect something more serious than a virus. At about 4 am Wednesday, the 28th, he passed a bloody-streaked mucus stool. This signaled to the doctor intussusception (Finally - a proper diagnosis). He was then transported to another hospital and the diagnosis was confirmed with an ultrasound. A previous x-ray had not shown anything. He was then given a barium enema (seven times) and it relieved the intussusception. When he came out of the procedure, he had a lot of bad bacteria released into his body, which sent him into a kind of shock, he turned grayish - mottled and was taking rapid shallow breaths. He was sent to the PICU until the next day. After he had stabilized was sent to a regular room and released on Thurs. the 29th. This all started 11 days after receiving his 3rd dose of the Rotavirus vaccine Rotateq. He received a dose at 2 months, 4 months and 6 months (it was after this he suffered from intussusception). If you have any questions - call me.					Y	3			U	11/14/2007	11/25/2007	11	He was then transported to another hospital and the diagnosis was confirmed with an ultrasound (a previous X-ray at the other hospital had not shown anything).  He was then given a barium enema (seven times) and it relieved the intussusception.	OTH	OTH						1						2	Bacterial infection; Barium enema; Dehydration; Haematochezia; Hypoventilation; Intensive care; Intussusception; Listless; Livedo reticularis; Mucous stools; Pallor; Shock; Skin discolouration; Ultrasound scan abnormal; Vomiting; X-ray; Barium enema; Blood culture; Blood test; Crying; Culture stool; Culture urine; Dehydration; Diet refusal; Haematemesis; Haematochezia; Intensive care; Intussusception; Irritability; Livedo reticularis; Mucous stools; Pyrexia; Respiratory rate increased; Ultrasound scan; Vomiting; X-ray	DTAP~SANOFI PASTEUR~C2607AA~3~UN~UN~DTAP (TRIPEDIA)~2|FLU3~SANOFI PASTEUR~UT2460EA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~SANOFI PASTEUR~UF192AA~3~UN~UN~HIB (ACTHIB)~2|PNC~PFIZER\WYETH~B087028~3~UN~UN~PNEUMO (PREVNAR)~2|RV5~MERCK & CO. INC.~1460U~3~PO~MO~ROTAVIRUS (ROTATEQ)~2|DTAP~SANOFI PASTEUR~C2607AA~3~UN~LL~DTAP (DAPTACEL)~3|FLU3~SANOFI PASTEUR~UT2460BA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~3|HIBV~SANOFI PASTEUR~UF192AA~3~UN~RL~HIB (ACTHIB)~3|PNC~PFIZER\WYETH~B087028~3~UN~LL~PNEUMO (PREVNAR)~3	USA	Hospitalisation	Influenza
0302027	01/09/2008	IN	56.0	56		M	01/06/2008	Constant consistent noticeable pain in upper left arm where all three shots were given.  Some joint pain/finger joint pain in left arm and hand, lymph node pain below ears; under arms.				Y					N	10/04/2007	10/06/2007	2		PUB	PVT	Oxybutynin ER 15 mg Quinapril 20 mg	None known	Mild high blood pressure, urges to urinate	see #7~Tdap (Adacel)~2~56.00~Patient|None known~ ()~~0.00~Sibling		1						1	Arthralgia; Injection site pain; Lymph node pain	FLU3~SANOFI PASTEUR~U2445AA~5~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0762U~2~~LA~HEP B (RECOMBIVAX HB)~1|TDAP~SANOFI PASTEUR~C2771AA~3~~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0302030	01/09/2008	MI	52.0	52		F	12/28/2007	12-28-07 complained of pain in deltoid since receiving flu vaccine 11-20-07.  No edema, erythema, tenderness with palpation.  Pain with movement.  Referred to private physician.									U	11/20/2007	11/20/2007	0		PUB	PUB	None	None	None			1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2526AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0302037	01/09/2008	NC				U	11/13/2007	Tetanus and diphtheria toxoid vaccine was refilled in hospital medication dispensing cabinet refrigerator instead of influenza virus vaccine (syringe version of product).  The wrong product selected in the pharmacy, then delivered to the ADC.  Nurse caught before medication administered.  Concern: When vaccines are removed from outer box, they look identical.  Concern for potential that this could happen again and patients could receive.  Differentiate inside packaging of products since outer box will most likely not be used in hospital settings when automated dispensing cabinets are utilized.  We separated products by storing in separate refrigerators, highlighted, shored information.														UNK	UNK						1						1	Medication error	FLU3~SANOFI PASTEUR~U2458FC~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U1954AB~UNK~UN~UN~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0302114	01/09/2008	PA	70.0	70		M	01/09/2008	Patient stated he developed hives on legs, lower back and gluteus after receiving influenza vaccine.  He was seen by his primary care provider two days after vaccination and was prescribed diphenhydramine and prednisone taper with instructions to report to ER if rash worsened or if he developed problems with breathing.				Y					Y	10/31/2007	10/31/2007	0		UNK	UNK	felodipine, chlorpromazine, omeprazole, simvastatin, valsartan		diabetes, GERD, HTN, hyperlipidemia, renal failure, schizophrenia			1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81270~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0302115	01/09/2008	NY	41.0	41		F	01/09/2008	Possible cellulitis of right upper arm 4 days after the administration of the vaccine.  Patient presented in the Emergency Department and complained of redness and pain at the injection site.  A 5x4 cm red area was noted on the right upper arm.  She was ordered on an oral antibiotic. She subsequently had 5 additional visits for this issue, 4 in the Emergency Department and one with her Primary Care Provider. A culture taken on 12/6/06 was negative for growth.  She reports that she has residual scar tissue in the are of the injection.   The individual reported that she had received the vaccinations in the same arm.  Medical record documentation indicates that she received the Influenza vaccine in the left deltiod and the Pneumovax vaccine in the right deltiod.				Y					N	11/29/2006	12/03/2006	4	Needle aspriation of the area on 12/6/06 was negative for growth.	UNK	UNK		None	No known allergies			1						1	Culture negative; Injection site cellulitis; Injection site erythema; Injection site pain; Injection site scar	FLU3~SANOFI PASTEUR~U22881AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0882F~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0302116	01/09/2008	UT	15.0	15		F	01/09/2008	Blisters on roof of mouth paralysis in legs passing out, bad headaches in back of her head, not being able to eat much food or drink felt overly full onset of Guillain Barre syndrome, still passing out and feeling dizzy after 2 months heavieness in legs sleeping excessivly feeling fatigued alot. 1/18/08-records received for DOS 1/11/08-ER visit for syncopal episode. Previously hospitalized for diffuse neurologic complaints. Guillain-Barre syndrome ruled out with negative MRI. Continues to have syncopal episodes, occasional fatigue, stomach upset, decreased oral intake. Tachycardia, anxiety, rapid respirations and syncope. No memory loss. Referred to outpatient neurology and pediatric psychiatry. DX: Persistent syncopal episodes. Per information received from annual follow up, it has been almost 5 mos, she still passes out, she gets dizzy on a daily basis. she now has to wear glasses from the seizures and passing out. And has a hard time keeping food down. Has lost 25 lbs and always tired, very fatigued. Many stays in the Hosp. and many tests. My daughters only got one shot out of 3. I would like more answers, is this ever going to stop-and if you could recommend any immunization attorneys that would be great. 1/19/2010 Last time she had a seizure was 2 months ago it seems to be backing off accept for all last year.				Y	Y	4			U	11/06/2007	11/30/2007	24	had 2 MRI's and blood workup reveals no infection or virus 1/18/08-records received-PE and EKG normal. Laboratory tests normal.	UNK	UNK	none at the time of this shot	none at the time of the shot	none	none~ ()~~0.00~Patient		1						1	Blood test normal; Convulsion; Corrective lens user; Decreased appetite; Diplegia; Dizziness; Fatigue; Fatigue; Headache; Hypersomnia; Hypophagia; Loss of consciousness; Nuclear magnetic resonance imaging normal; Oral mucosal blistering; Sensation of heaviness; Weight decreased; Convulsion; Dizziness; Guillain-Barre syndrome; Hyperventilation; Hypoaesthesia; Laboratory test; Loss of consciousness; Neurological examination; Oropharyngeal blistering; Syncope; Abasia; Blood test; Fatigue; Guillain-Barre syndrome; Hypoaesthesia; Laboratory test; Loss of consciousness; Malaise; Nuclear magnetic resonance imaging; Paralysis; Stress	FLUX~UNKNOWN MANUFACTURER~~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~1426F~1~UN~LA~HPV (GARDASIL)~1|HPV4~MERCK & CO. INC.~~1~UN~UN~HPV (GARDASIL)~2|HPV4~MERCK & CO. INC.~~UNK~UN~UN~HPV (GARDASIL)~3	USA	Hospitalisation	Influenza
0302123	01/09/2008	MD	49.0	49		M	01/09/2008	Periorbital edema noted 6-8hrs after vaccination, resolved within 48hrs.									Y	10/22/2007	10/22/2007	0		UNK	UNK						1						1	Periorbital oedema	FLUX~UNKNOWN MANUFACTURER~~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0302126	01/09/2008	CA	60.0	60		F	01/09/2008	Presented to hospital 11/29/07 with severe low back pain, tingling, numbness and burning sensation in BLE. Dizziness, unsteadiness & weakness. Developed severe paraesthesias follwoing the flu shot. Diagnosed Guillian Barre Syndrome 2nd to flu shot. Demyelinating Polyneuritis. Pain under control by discharge to home 12/21/07 2/6/08-records received for DOS-11/28-12/21/07-DC summary not available. C/O severe low back pain, tingling, numbness and burning sensation in both lower extremities. Unsteadiness and weakness. After flu shot developed diarrhea and nauseous feeling. PE: positive Romberg phenomena, areflexia in both lower extremities without affecting the bulbar muscles or cranial nerves. Severe stabbing pain low back area radiating to thoracic region. Developed severe pain in epigastric area with bloating. DX: acute pancreatitis. 4/3/08-DC Summary received for DOS 11/28-12/21/07-DC DX: Acute inflammatory demyelinating polyneuropathy or Guillain-Barre syndrome following vaccineation. Acute or subacute onset of pancreatitis, probably related to IVIG immunoglobulin-G treatment. Severe neuropathy in both lower extremities. Pneumonia. Severe ataxic gait. Abdominal pain from pancreatitis. Chronic pain as result of demyelination of dorsal ganglion resulting in acute Guillain-Barre syndrome. Ptient recovered enough to go home but had residual neurological findings for which she was to recieve home rehab.					Y	23			Y	11/07/2007	11/28/2007	21	LP with increased CSF protein; 2/6/08-records received-CSF: protein 193. Urine culture E.coli.  MRI multilevel degenerative disk disease with very small disk protrustions at L3-4, L4-5, discogenic disease at T4-5 and T5-6.	UNK	UNK		None	No medical conditions, unknown to everything else.			1						1	Abdominal pain upper; Asthenia; Back pain; Balance disorder; Burning sensation; CSF protein increased; Demyelinating polyneuropathy; Dizziness; Escherichia infection; Guillain-Barre syndrome; Hypoaesthesia; Intervertebral disc protrusion; Lumbar puncture; Pancreatitis acute; Paraesthesia	FLU3~SANOFI PASTEUR~U2498AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0302127	01/09/2008	NM	0.15	0	.2	F	01/09/2008	2 SMALL MASSES AT AREA OF INJECTIONS WITH MILD CELLULITIS				Y					Y	12/28/2007	12/28/2007	0		UNK	UNK						1						1	Injection site cellulitis; Injection site mass	FLU3~SANOFI PASTEUR~UT2459LA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0807F~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1357U~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0302136	01/09/2008	WI	1.3	1	.3	M	01/09/2008	Patient was sent to ER 12/18/07 with cough and breathing difficulty.  No fever.  Diagnosed with pneumonia and bronchiolitis.  Child received influenza vaccine 12/12/07 - mother won't give 2nd influenza - feels this is cause. 1/17/08-records received for DOS 12/18/07-Assessment:Pneumonia. Broncholitis. Presented to ED with cough and difficulty breathing.  PE: some grunting respirations without stridor.				Y					Y	12/12/2007	12/18/2007	6	1/17/08-records received-CXR: right middle lobe infiltrate.	PVT	OTH		None	Slight speech delay 1/17/08-records received-PMH: preterm delivery at 35 weeks.			1						1	Bronchiolitis; Cough; Dyspnoea; Pneumonia	DTAP~SANOFI PASTEUR~C2797AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT24060EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0376U~3~IM~RL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0869U~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0302141	01/09/2008	NC	1.0	1	.0	M	01/09/2008	Rash-cleared on own early Nov. 07.  12-31-07, 1-8-08, 1-9-08 seen for abscess on L leg, red, swollen nodule.				Y					Y	10/23/2007				PVT	PUB						1						1	Injection site abscess; Injection site erythema; Injection site nodule; Injection site swelling; Rash	FLU3~SANOFI PASTEUR~U2458BA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0799U~1~UN~LL~HEP A (VAQTA)~1|MMR~MERCK & CO. INC.~0204U~1~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1106U~1~UN~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0302547	01/09/2008	PA	0.2	0	.2	M	01/04/2008	Information has been received from a health professional concerning a 13 month old 25 lb. 13 oz. 33 1/2 inch male with an allergy to OMNICEF who on 24-OCT-2007 at 11:30 hours received his first subcutaneous dose in the right of ProQuad (Oka/Merck upgrade process) (lot#658314/0774U). Concomitant vaccinations included a first intramuscular dose in the left of Fluzone (lot#U2493AA) and a fourth intramuscular dose in Hib (unspecified carrier (lot# UF204PC). Illness reported at the time of vaccination included being fussy and a slight cough not accompanied by fever for 2 to 3 days. No adverse events were reported following prior vaccination. It was reported that on 31-OCT-2007, he was seen in the office by the physician after on 28-OCT-2007 he developed a rash that started on his face, and after 4 days new ones developed and spread. It was reported that the patient developed greater than 100 lesions that were diffuse papules with few tiny vesicles on a red base on the patient's trunk, face and extremities. It was reported that the patient was not ill, no fever and was pleasant. No diagnostic tests were reported. Current patient status was not reported. Additional information has been requested.				Y					U	10/24/2007	10/28/2007	4		PVT	PUB		Irritability; Allergic reaction to antibiotics			WAES0712USA01531	1						1	Inappropriate schedule of drug administration; Irritability; Rash papular	FLU3~SANOFI PASTEUR~U2493AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF204PC~4~IM~UN~HIB (ACTHIB)~1|MMRV~MERCK & CO. INC.~0774U~1~SC~UN~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0302566	01/09/2008	CO	1.0	1	.0	F	01/04/2008	Initial and follow up information has been received from a physician concerning a 22 month old white female with esophageal acid reflux and a history of bronchiolitis and incisional hernia repair, with no known food or drug allergies who on 02-OCT-2006 was vaccinated subcutaneously into the left arm with a first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 655140/0832F).  Concomitant vaccine therapy that same day included a fourth dose intramuscularly into the right thigh of PREVNAR (Lot #B08683C), a first dose of HAVRIX (Lot #U2174DA) intramuscularly into the right thigh, and a first dose of FLUZONE (lot #U2174DA) administered intramuscularly into the left thigh.  Concomitant therapy included: PREVACID and ATARAX, (also reported to have been treatment).  On 21 AUG 2007 the patient, presented for a sick visit with a rash to the left anterior chest, left axilla, and scattered hives throughout body.  The mother noted that the patient had had a paradoxical reaction to BENADRYL the day before.  The rash was described as red, raised, blistery and had been spreading for the last 4-5 days, with an onset of approximately 16 SEP 2007.  It was reported that the sibling had a few red lesions on her neck 2 weeks ago.  The patient was afebrile, 97 degrees, (tympanic), healthy appearing, alert and interactive and in no acute distress.  The physical examination was essentially unremarkable.  Pin-point vesicles on a red base in small clusters were present on the left side of the chest, axilla, arm, and back.  A few isolated similar lesions were present on the right shoulder and leg.  No super infection was present.  Final assessment was Varicella without mention Comp, also reported as shingles.  A non-specific mild/resolving diaper dermatitis was also noted at the time of examination.  There was no illness at the time of vaccination.  The patient has no reported adverse events with previous vaccines.  Polysporin was prescribed to treat the rash.  At the time of reporting the patient was considered recovered, date unknown.  Symptoms reportedly persisted until Labor Day 03 SEP 2007.  It was also confirmed that the patient had only one episode of shingles.  There was no product quality complaint.				Y					N	10/02/2006	08/16/2007	318	None	PVT	PVT	ATARAX, 3/4 dose; PREVACID, 15 mg	Oesophageal acid reflux	Bronchiolitis; incisional hernia repair; the patient has no reported adverse events with previous vaccines.		WAES0710USA03266	1						1	Blister; Dermatitis diaper; Erythema; Herpes zoster; Rash; Skin lesion; Urticaria; Varicella	FLU3~SANOFI PASTEUR~U2174DA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~U2174DA~1~IM~RL~HEP A (HAVRIX)~1|MMRV~MERCK & CO. INC.~0832F~1~SC~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08683C~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0302576	01/09/2008	FL	0.5	0	.5	M	12/17/2007	This case was reported by a healthcare professional and described the occurrence of seizure in a 6-month-old male subject who was vaccinated with Pediarix for prophylaxis. Previous and/or concurrent vaccination included Haemophilus influenzae type b vaccine given on 19 December 2006; influenza vaccine given on 19 December 2006; influenza virus vaccine given on 19 December 2006; pneumococcal vaccine given on 19 December 2006. On 19 December 2006 at 10:30 the subject received 3rd dose of Pediarix (.5 ml, unknown). On 19 December 2006, 3 hours after vaccination with Pediarix, the subject experienced continual seizure and problem breathing. The subject was hospitalised for 3 days and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were resolved. The reporter stated that even though the subject received additional vaccines that day, it was thought that Pediarix was the cause of the adverse events. Follow up information received on 19 January 2007 indicated that the reporter felt that the events were not related to treatment with Pediarix. The events remained resolved and were not considered at the time of follow-up to be severely or permanently disabling.			Y		Y	3			Y	12/19/2006	12/19/2006	0	A CT of the brain was performed on an unknown date. The results were not reported.	PVT	PVT		Unknown			A0632901A	1						1	Convulsion; Dyspnoea; Scan brain	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B074AA~3~UN~UN~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~42284AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF042AA~UNK~UN~UN~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~8086708~UNK~UN~UN~PNEUMO (PREVNAR)~1	USA	Life Threatening,Hospitalisation	Influenza
0302677	01/09/2008	CA	1.2	1	.2	M	12/17/2007	This case was reported by a healthcare professional and described the occurrence of injection site redness in a 1-year-old male subject who was vaccinated with Pediarix for prophylaxis. The subject had no adverse events following receipt of prior immunizations. The subject had no pre-existing medical conditions. The subject's concurrent conditions were not reported. There were no concurrent medications. On 12 December 2006 at 10:00 a.m. the subject received 4th dose of Pediarix in the right arm. Pediarix is not recommended as a booster (or 4th dose) in the diphtheria and tetanus toxoids and acellular pertussis vaccine or inactivated poliovirus vaccine immunization series. On 12 December 2006, the subject also received Hib vaccine and influenza virus vaccine at unspecified sites of administration. On 13 December 2006, 1 day after vaccination with Pediarix, the subject experienced redness and edema at the injection site of Pediarix. On 14 December 2006, the subject was seen at a physician's office and was diagnosed with injection site cellulitis. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with Rocephin and Augmentin. At the time of initial reporting, 14 March 2007, the events were resolved.				Y					Y	12/12/2006	12/13/2006	1	UNK	PVT	PVT	No concurrent medication.	Unknown	The subject had no adverse events following receipt of prior immunizations. The subject had no pre-existing medical conditions. The subject's concurrent conditions were not reported. The healthcare professional also reported that 3 other subjects experienced injection site reactions following receipt of Infanrix from lot AC14B047AA. Please see cases A0643632A, A0643638A and A0643639A.		A0643616A	1						1	Inappropriate schedule of drug administration; Injection site cellulitis; Injection site erythema; Injection site oedema; Medication error	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B084CA~4~UN~RA~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U219BA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0785F~UNK~UN~UN~HIB (PEDVAXHIB)~1	USA	Emergency room visit	Influenza
0302129	01/10/2008	CA	38.0	38		F	01/09/2008	11/22/2007 sudden complaint of tingling of hands and upper back ache around 8:30 pm. Went to lay down. Couldn't get comfortable. Felt like heart was racing. Checked BP and pulse, both high for me at 150/96, pulse 98. Felt chills and body felt cold. I just did not feel good. Went to urgent care. Walked in from the parking lot holding onto husband's arm. Feeling generalized weakness. Diagnosed with dehydration. Unable to walk back to the car because legs felt weak, my husband wheeled me in the wheelchair to the car.  I held onto his arm walking into the house. I was told to drink Pedialite or Gatorade. Went straight to bed at around 10:00 pm. Drank Pedialite at bedside. Woke up at around 1 am on 11/23/2007, thinking Pedialite is too sweet, I need water. Husband was sleeping with our 10 month old son in his room. I sat at the edge of the bed thinking I need to get to the kitchen for water for my dehydration. I put my left foot on the floor and I ended up on my knees. I could not stand. I crawled to my son's room to wake up my husband to call 911. I was at ER around 1:30 am with both legs paralyzed and hands were very weak. I was admitted to ICU diagnosed by the Neurologist with Guillain-Barre Syndrome, suspected due to the Influenza Vaccine that I received 6 weeks prior. I had a CT scan, lumbar puncture, MRI and blood work done. The next day I was treated with Plasma Phoresis. I had 5 treatments over a course of 7 days. After each treatment I started to have little improvement in my right leg then left foot. I was then transferred to Rehabilitation Center on 12/4/2007. I was discharged home on 12/28/2007. I am wheelchair bound, but able to get around short distances with a front wheel walker. Left leg and left hand still weaker than right side. Weak grips. Nipple line to toes have impaired sensation. Currently disabled. I am receiving home health P.T. and will receive home health O.T. 1/22/08-records received for DOS 11/23-12/04/07 DC DX: Guillain Barre syndrome, status post plasmapheresis. Secondary diagnosis:urinary tract infection. Presented to ER with C/O weakness of both upper and lower extremities starting 1 day before admission. Feels sharp pain involving upper back and chest. Numbness and tingling to both upper and lower extremities. Inability to walk.  Per 60 day follow up: Still have weakness in left hand, weakness in left leg greater than right, impaired sensation from below breast line to toes, occasional leg spasms, loss of bladder control.			Y	Y	Y	11			N	10/08/2007	11/22/2007	45	CT scan neg, lumbar puncture, MRI neg 1/22/08-records received-Labs: Hct 28.7. EOS % high 5, WBC 13.2, ESR 30, PT and PTT increased. Urinalysis nitrites positive, WBC 159, and culture positive for e. coli. CSF normal. CT brain normal.CT chest normal.	UNK	UNK	prenatal vitamin, 1 tab, once a day	none	none			1						1	Abasia; Activated partial thromboplastin time; Back pain; CSF cell count normal; Chest X-ray normal; Chills; Computerised tomogram normal; Culture positive; Dehydration; Diplegia; Eosinophil percentage increased; Feeling cold; Grip strength decreased; Guillain-Barre syndrome; Intensive care; Lumbar puncture; Muscular weakness; Nitrite urine present; Nuclear magnetic resonance imaging normal; Palpitations; Paraesthesia; Plasmapheresis; Prothrombin time prolonged; Scan brain; Sensory loss; Urine analysis; White blood cell count decreased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79898~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0302162	01/10/2008					M		A serious report was received from a consumer concerning a male adult.  No medical or drug history was reported for this patient.  The patient received FluMist on an unreported date.  A wife's email states We have questions about whether or not my husband's FluMist vaccine caused his current pericarditis diagnosis.  The patient remained hospitalized at the time of the report.  Additional FluMist dosing is not indicated for this season.  The reporter did not provide a causality assessment for the adverse event reported.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.					Y	0			U					OTH	OTH	Concomitant drug(s) not reported				MEDI0006348	1						1	Pericarditis	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0302216	01/10/2008	PA	54.0	54		F	01/10/2008	Pain limited range of motion to R deltoid area of site of immunization.									U	01/07/2008	01/09/2008	2		MIL	MIL						1						1	Injected limb mobility decreased; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA320BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0302232	01/10/2008	ID	44.0	44		F	12/11/2007	Client's R arm sore after immunizations on 12-7-07.  On 12-8-07 p.m. client's back started hurting.  R arm getting very sore and flu-like symptoms.  Client had to take 2 extra strength Tylenol then and later as needed.  On 12-9-07 Sunday night, client noticed that her R arm had a 3 x 5 to 6 long raised, warm and rough to touch, red hives which was following her bicep & it was itching at and around injection site.									Y	12/07/2007	12/08/2007	1		PUB	PVT	Cenestin, Prometrium, Paxil, Chantix	Depression			ID07051	1						1	Back pain; Influenza like illness; Injection site erythema; Injection site pruritus; Injection site urticaria; Injection site warmth; Pain in extremity	FLU3~SANOFI PASTEUR~U2512AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB107BA~1~IM~RA~HEP A + HEP B (TWINRIX)~1|PPV~MERCK & CO. INC.~0804U~2~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2825AA~1~IM~LA~TDAP (ADACEL)~1|TYP~SANOFI PASTEUR~Z04792~1~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0302233	01/10/2008	ID	1.1	1	.1	F	12/14/2007	Several hours after receiving vaccinations pt. developed hives.									Y	12/13/2007	12/13/2007	0		PVT	PUB	None	None	None		ID07050	1						1	Urticaria	FLU3~SANOFI PASTEUR~U2458BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1801U~1~IM~RL~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~1510U~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0302236	01/10/2008	ID	44.0	44		F	11/16/2007	Developed discomfort left side of body after injection L deltoid.  Developed over an hour with left jaw & neck aching.  Slight difficulty swallowing, no respiratory changes.  Rec'd 25 mg Benadryl from paramedic per her request.  States she felt better in about an hour.  Called client 11/15/07 pm, stated she felt better after Benadryl.  Called 11/16/07 at work, sl. residual.									Y	11/15/2007	11/15/2007	0	None	UNK	PVT		None	None		ID07048	1						1	Discomfort; Dysphagia; Neck pain; Pain in extremity; Pain in jaw	FLU3~SANOFI PASTEUR~2504AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0302238	01/10/2008	ID	1.1	1	.1	M	11/07/2007	Pt. started having a fever at about 12:00pm, it continues to get higher & they went to the ER at 7:00pm when temp. was 106.5 degrees.  They did some labs and a CXR, was treated with Tylenol & Motrin & sent home.				Y					Y	11/06/2007	11/06/2007	0	CBC-normal; CXR-negative	PVT	PUB		Upper respiratory illness			ID07047	1						1	Chest X-ray normal; Full blood count; Full blood count normal; Pyrexia	FLU3~SANOFI PASTEUR~UT2460EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0185U~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08702A~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1340U~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0302256	01/10/2008	OK	44.0	44		F	01/03/2008	Swollen arm, itchy, very hot to the touch w/rash that spread. very bad headache. fever, chills and sweating. Lethargic and very tired. Missed work. Felt very bad for 4 days and then felt worn out for another 1 1/2 weeks.									Y	11/09/2007	11/09/2007	0	None	OTH	PVT						1						1	Activities of daily living impaired; Chills; Fatigue; Headache; Hyperhidrosis; Lethargy; Malaise; Oedema peripheral; Pruritus; Pyrexia; Rash; Skin warm	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0302257	01/10/2008	TN	67.0	67		F	01/04/2008	Beginning 2-4 weeks after vaccination patient states has sharp pain that runs between the shoulder & elbow with exertion of muscle & joint.  Per consult of regional office I suggested patient consult PCP.									U	11/02/2007	11/15/2007	13	None	UNK	UNK		None apparent	None			1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2514AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U1734EA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0302258	01/10/2008	TN	65.0	65		M	01/04/2008	Beginning 2-4 weeks after vaccination, patient states has sharp pain that runs between the shoulder and elbow with exertion of muscle and joint.  Per consult of regional office suggested patient consult PCP.										11/02/2007	11/15/2007	13	None	UNK	UNK		None	None			1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2514AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U1734EA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0302259	01/10/2008	IL	23.0	23		F	11/07/2007	Patient was nervous for vaccine.  She sat for the vaccine and was told to wait 15 minutes before leaving.  About 4 minutes after the shot, she told boyfriend she was going to pass out and she did.  BP - 133/72.  Patient said she had a vagal response to pain.									Y	11/07/2007	11/07/2007	0		PUB	PVT		None	None			1						1	Loss of consciousness; Nervousness; Syncope vasovagal	FLU3~SANOFI PASTEUR~U2514AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0302260	01/10/2008	OR	22.0	22		M	11/04/2007	L upper arm 1 cm & 3 (1-3 mm) urticarial wheals (lesions).  Central blanching & surrounding 3 cm area of erythema and redness.  Started 20 min ago just after lunch.  Had influenza vaccine yesterday.									Y	11/03/2007	11/04/2007	1		MIL	MIL				similar to above~Anthrax (no brand name)~5~21.00~In Patient		1						1	Erythema; Pallor; Urticaria	FLU3~SANOFI PASTEUR~U2516AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0302261	01/10/2008	CA	1.0			M	01/04/2008	Patient developed a sensitive hyperpigmented area at site of vaccines.  Was initially red, then became bruise-like and now is red/purple.  No lump felt.  Not hot.  1x 1/2 on left anterior thigh.									U				None	MIL	MIL	Zantac	Cold symptoms	Reflux			1						1	Injection site bruising; Injection site discolouration; Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~UT2459KA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0500U~3~IM~RL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~0283U~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0720U~1~~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0302263	01/10/2008	FL	36.0	36		M	01/09/2008	Pt developed influenza B.									U	09/19/2007			positive nasal swab	PVT	OTH		None				1						1	Influenza; Influenza serology positive	FLU3~SANOFI PASTEUR~U2440AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0302272	01/10/2008	NV	1.6	1	.6	M	12/18/2007	Puffy eyes, erythema multiforme (no mucosal involvement, no trouble breathing).  Treated with epinephrine in the ER several times, oral Prednisone, Benadryl, dexamethasone.  Symptoms occurred 6 days after vaccine and the rash lasted about 4 days then resolved.				Y					Y	11/12/2007	11/19/2007	7	Platelet 640 (not low); ESR 8 (normal)	OTH	PUB		Upper respiratory infection	NKDA, possible allergy to chocolate	fell & broke tooth~Influenza (Seasonal) (no brand name)~UN~1.60~In Patient		1						1	Erythema multiforme; Eye swelling; Platelet count normal; Rash; Red blood cell sedimentation rate normal	FLU3~SANOFI PASTEUR~UT2456EA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0302297	01/10/2008	NC	17.0	17		M	01/10/2008	PATIENT HAD RECEIVED INFLUENZA VACCINE EARLIER IN THE DAY BY HIS PERSONAL PHYSICIAN & RECEIVED MENINGOCOCCAL VACCINE AT PUBLIC HEALTH DEPT LATER IN THE DAY ON 1/7/2008. AT 3 A.M. ON 1/9/2008, PATIENT HAD REDNESS & ITCHING OF FACE; SWELLING OF FACE, HANDS & TONGUE.  ACCORDING TO PHYSICIAN'S REPRESENTATIVE, PATIENT WAS SEEN ON 1/9/2008 IN LATE A.M. AND DIAGNOSED WITH A REACTION TO EITHER THE FLU VACCINE OR THE MENINGOCOCCAL VACCINE.  PATIENT GIVEN MEDROL (METHYLPREDNISOLONE 4 MG) DOSE PACK.  AS OF 11:30 AM 1/10/2008, PATIENT'S SYMPTOMS HAVE DIMINISHED, BUT NOT COMPLETELY RESOLVED (ACCORDING TO PATIENT'S PARENTS).				Y					N	01/07/2008	01/09/2008	2		UNK	UNK	NONE	NONE	NONE KNOWN			1						1	Erythema; Oedema peripheral; Pruritus; Swelling; Swelling face; Swollen tongue; Vaccination complication	FLU3~SANOFI PASTEUR~U2448AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2540AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0302323	01/10/2008	TX	27.0	27		M	01/10/2008	Patient came in for five vaccines (Hepatitis B, Tdap, Hepatitis A, Influenza, and Meningococcal) on January 10, 2008 at 3:15 p.m. Patient was asked if he had allergies to medications, foods or previous vaccines. He denied having any allergies, except to tomatoes at one time. Patient was alert oriented to place, time and name. Patient was reminded that if he were to feel light headed to notify administrator so that the vaccines could be stopped. He acknowledged. Patient was sitting in a chair at the time of administration of vaccines. Tdap, Hepatitis A and Meningococcal were administered via intramuscular injections on the right deltoid. Patient was asked if he felt okay, and he stated yes. Hepatitis B and the Influenza Vaccine were then placed on the left deltoid via intramuscular injection. After the completion of the vaccines patient complained of feeling light headed. He then placed his head in between his legs for about 3 minutes; he proceeded to sit up again. But, he felt dizzy and began sweating profusely. Patient stated that he had not eaten all day long. He was offered a hard candy and chewed on it for a while. Again, he placed his head in between his leg. He was asked to spit out his candy so as to prepare to lay him flat on the floor. With no relief in dizziness and sweating patient was assisted down to the floor. His legs were elevated above the level of his heart. Emergency medical services were notified. After remaining on the floor of the clinic for a couple of minutes, patient stated he felt better. His vital signs were 120/72 mm/Hg. blood pressure and 72/minute pulse. Again his pulse was checked minutes later and it was 80/minute. E.M.S. arrived at the scene and rendered first aid. Patient refused medical transport and stated he felt much better. He stated that he takes Lexapro (unknown dosage) and another bi-polar medication. Patient remained at the clinic for about 30 minutes before requesting to step outside to smoke a cigarette. Patient did not have any wheezing or difficulty breathing. Patient was alert oriented to time, place and person and was very cooperative. Patient did state that he did have a similar reaction when he was given multiple vaccines and had blood drawn several years prior.									Y	01/10/2008	01/10/2008	0		UNK	UNK		History of bi-polar disorder; currently taking medications for it--Lexapro (unknown dosage and another bi-polar medication).	Bi-polar disorder.	Vertigo/unknown type of vaccines~ ()~~0.00~Patient		1						1	Dizziness; Hyperhidrosis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79718~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~MERCK & CO. INC.~1054U~UNK~IM~LA~HEP B (RECOMBIVAX HB)~1|HEPA~MERCK & CO. INC.~0813R~1~IM~RA~HEP A (VAQTA)~1|MNQ~SANOFI PASTEUR~U2405AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2770AA~1~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0302324	01/10/2008	PA	12.0	12		F	01/10/2008	24 days after having the flu shot and Gardasil vaccine simultaneously, experienced an episode of nausea, dizziness, severe headache, seeing black spots, fainted and seizure activity (her teacher reported that she was shaking). She continues to have frequent headaches, nausea and occassional dizziness, & anxiety over the above.									U	10/30/2007	11/23/2007	24	We were instructed to log symptoms for 1 month. When examined her regular Dr. was unavailable so she was seen by another doctor, who insisted that the symptoms had no relation to the injection and stated that she probably hit her head when she fainted (which was denied by the teacher that witnessed the syncopal episode). Because patient was having abdominal pain the day of the exam on 1/3/08, Dr. ordered an abdominal sonogram and told her to drink more water for the headaches.	UNK	UNK						1						1	Anxiety; Convulsion; Dizziness; Headache; Nausea; Syncope; Ultrasound abdomen; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|UNK~UNKNOWN MANUFACTURER~Gardasil ??~1~UN~RA~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA		Influenza
0302327	01/10/2008	WA	45.0	45		F	01/03/2008	L deltoid swelling, redness, pain.  Onset 12/31/07.  Tx: ice, muscle relaxer.									Y	12/31/2007	12/31/2007	0		PVT	PVT	loratadine, Protonix, Singulair, Qvar, Sudafed, metoclopramide		Allergies to Codeine, Ceftin. Dx: GERD, asthma			1						1	Erythema; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2509AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1382U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0302331	01/10/2008	MN	61.0	61		F	01/10/2008	Cellulitis right arm.				Y					U	01/08/2008	01/09/2008	1		PVT	UNK	Paxil, Lorazepam	Bronchitis-viral	Sulfa allergy	cellulitis~Vaccine not specified (no brand name)~UN~6.00~In Patient		1						1	Injection site cellulitis	FLU3~SANOFI PASTEUR~U2478AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0991U~1~IM~LA~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~1413U~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0302461	01/11/2008	MA	20.0	20		F	01/11/2008	Had pea sized lump under skin at vaccine site after HPV vaccine RUE    then slept on floor 1/3/08 at friends and next am site sore and red worsened over next few d still looks red, tender no fevers no d/c. 2 cm area erythema, induration, warmth, tenderness R deltoid c/w injection site. No fluctuance appreciated.				Y					Y	12/17/2007	01/03/2008	17		UNK	UNK	Albuerol MDI Singulair	None	Asthma			1						1	Injection site erythema; Injection site induration; Injection site nodule; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U2523AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1522U~1~IM~RA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0302462	01/11/2008	NH	31.0	31		F	01/10/2008	Information has been received from a physician, concerning a 32 year old female patient with attention deficit disorder, migraines and irregular menstruation, and a history (02-OCT-2007) of vaccination with Pneumovax 23 vaccine (lot #657626/1084U) while hospitalized with bilateral pneumonitis which required intubation. On 04-JAN-2008 the patient was again vaccinated in the right shoulder, with a dose of Pneumovax 23 (lot # not reported). Concomitant vaccine therapy included a dose in the left shoulder, of influenza virus vaccine (STRATTERA), desogestrel/ethinyl estradiol (DESOGEN), estradiol (ESTRACE), hyoscyamineSO4 (LEVSIN) and rizatriptan benzoate (MSD). On 05-JAN-2008, 24 hours after vaccination, the patient developed a fever of 102 F, myalgia, photophobia, pain and swelling at the injection site in right shoulder, and leukocytosis. She was hospitalized, and treatment included ertapenem (INVANZ), administered twice, ibuprofen and intravenous fluids. Diagnostic labs were obtained (not specified), as well as a chest x-ray (results not provided). On 07-JAN-2007, the patient was afebrile, but had continued leukocytosis. The physician stated the patient was recovering from the events. The physician considered the events to be serious as an other important medical event. Additional information has been requested.				Y	Y	0			N	01/04/2008	01/04/2008	0	diagnostic laboratory 01/05/08 leukocytosis; chest X-ray 01/05/08; body temp 01/05/08 102 degr	OTH	OTH	Strattera; Desogen; Estrace; Levsin; Maxalt; Trazodone hydrochloride	Attention deficit disorder; Migraine; Menstruation irregular	Pneumonitis; Intubation		WAES0801USA00895	1						1	Body temperature increased; Chest X-ray; Injection site pain; Injection site swelling; Laboratory test; Leukocytosis; Myalgia; Photophobia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0302467	01/11/2008	GA	0.53	0	.5	F	01/11/2008	Infant received administration of Pediarix, hib (Sanofi), Fluzone, Prevnar, and Rotateq on 10/12/07. She had received Pediarix, Hib, Prevnar, and Rotateq previously on 6/8/07 and 8/10/07 without any adverse event.  This was her first flu vaccine dosage. That evening around 8 p.m. the infant developed high fever to 103 and had a seizure.  After the seizure, the infant appeared normal.  She had no further fever after that night. She has been growing and developmentally normal since that evening without any further seizure activity.									Y	10/12/2007	10/12/2007	0		UNK	UNK	none	none	none			1						1	Convulsion; No reaction on previous exposure to drug; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B133AA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2456BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF211AA~3~IM~RL~HIB (ACTHIB)~1|RV5~MERCK & CO. INC.~O97OU~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0302471	01/11/2008	NY	71.0	71		F	01/05/2008	Pain, paresthesias in limbs, weakness, areflexia.  Diagnosed as Guillain Barre syndrome. 1/28/08-records received for DOS 11/28-12/13/07-DC DX: Guillain-Barre syndrome. On 11/17/07 developed pain and numbness in both feet and pain in hands, pain and numbness persisted began to ascend to her legs. This is the second time the patient has experienced these symptoms. Eight years ago had similar symptoms of ascending numbness and weakness after receiving the flu vaccine but not as severe. Developed decreased muscle strength bilaterally in legs, unsteady gait.					Y	15			Y	11/05/2007	11/17/2007	12	1/28/08-records received-Labs WNL. CT spine showed degenerative changes of C5-C6 and C1 and C2. Lumbar puncture unsuccessful.	PVT	PVT	Maxzide	None	Well-controlled hypertension 1/28/08-records received-PMH: left ear cochlear implant. Chronic mild neutropenia. Trace aortic insufficiency and tricuspid regurgitation. Trileaflet aortic valve. Osteoporosis of lumbar spine. Osteopenia of hip.	similar type neuropathy following flu shot 5-6 years ago, seen by local neurologist, not then diagnosed as Guillain Barre~Influe		1						1	Areflexia; Asthenia; Guillain-Barre syndrome; Pain; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA035AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0302476	01/11/2008	OH	37.0	37		F	01/11/2008	Patient reports having an achy arm from her shoulder to fingertips, throbbing and cold sensation, radiating up to her nect, ribs.  No redness or swelling at injection site.  She also reports heartburn that wouldn't go away. Denies chest pain.  Sx started to improve after 1 1/2 days but lasted 3 days.  Sx were reported on her left side (where the injection was given).  She has a hx of heartburn but this time it lasted.  She said that ibuprofen 600 mg did not relieve the discomfort.  Pain was severe enough to disrupt her sleep.  She spoke with her family physician but he did not seem concerned or advise any medical follow-up.  Symptoms have completely resolved.  She says that she typically experiences severe pain after a flu shot but not as extensive as this time.									Y	11/09/2007	11/09/2007	0	None	UNK	UNK	None	Patient denies.	Sulfa allergy, mild mitral valve prolapse (w/o regurgitation), hx of preventricular contractions (PVCs)			1						1	Dyspepsia; Feeling cold; Pain; Sleep disorder	FLU3~SANOFI PASTEUR~U2465AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0302481	01/11/2008	TX	16.0	16		M	01/11/2008	Trouble in breathing at night with stridor lasting for four seconds.  He never had asthma.  He was getting these episodes 2-3 times a wk.									U	12/17/2007	12/19/2007	2	Seen by ENT; lateral X-ray of neck normal; pending appt with allergy specialist	PVT	PUB		None	None			1						1	Dyspnoea; Stridor; X-ray normal; Dyspnoea; Stridor; X-ray normal	FLU3~SANOFI PASTEUR~U2508AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB17AA~UNK~UN~RA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2420AA~UNK~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|FLU3~SANOFI PASTEUR~U2508AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB17AA~UNK~UN~RA~HEP A (HAVRIX)~2|MNQ~SANOFI PASTEUR~U2420AA~UNK~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2	USA		Influenza
0302483	01/11/2008	CA	33.0	33		F	12/13/2007	IM influenza vaccine was mistaken for 'FluMist' and administered to the nasal passage as a liquid. Once mistake was determined it was given IM.										12/09/2007			None	MIL	MIL		None known	None known			1						1	Incorrect route of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0302485	01/11/2008	WI	7.0	7		F	01/07/2008	Bronchospastic cough that persisted for 2 weeks, worse at night. No other symptoms - gave 5 day course of 1mg/kg steroid.				Y					U	12/20/2007	12/21/2007	1		PVT	UNK	None	None	None			1						1	Bronchospasm; Cough	FLUN3~MEDIMMUNE VACCINES, INC.~500489P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0302487	01/11/2008	WI	71.0	71		F	01/07/2008	Patient called pharmacy eve of her shots & said her left arm (Pneumovax arm) was hurting and felt like there was an egg-shaped lump in her arm.  She took Tylenol & it felt a little better, but still hurt.									Y	10/25/2007	10/25/2007	0		OTH	PVT		None	Morphine, dicyclomine, oxycodone, sulfa			1						1	Injection site mass; Injection site pain	FLU3~SANOFI PASTEUR~U2441AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0804U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0302489	01/11/2008	MS	15.0	15		F	12/27/2007	Large area bright red raised rash (L) arm at injection site, edema, pain. Fever 101.2.				Y					Y	12/20/2007	12/21/2007	1	Neg flu; UTI; Bronchitis	PUB	UNK	None	none	None			1						1	Bronchitis; Influenza serology negative; Injection site erythema; Injection site oedema; Injection site pain; Injection site rash; Pyrexia; Urinary tract infection	FLU3~SANOFI PASTEUR~U2499AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB431BA~1~IM~RA~HEP B (ENGERIX-B)~1|PPV~MERCK & CO. INC.~0859U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0302496	01/11/2008	NV	71.0	71		F		Laryngitis, tight chest, wheezing, weakness. RX: Spiriva									N	11/14/2007	11/16/2007	2	Mild wheezing/ Laryngitis	PVT	PVT	Spiriva	COPD				1						1	Asthenia; Chest discomfort; Laryngitis; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80687~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0302497	01/11/2008	TN				M	01/11/2008	Has arthralgias/weakness with evidence of joint swelling in hand. Arthralgias included neck/shoulder/arms/hands.				Y					U	11/14/2007	11/29/2007	15	HgB1C 6.6, ESR 13, WBC 7.8, Vit D -T- 12 cc) Hct-40.7	OTH	OTH		None	DM, HTN, Hyperlipidemia, Diabetic Neuropathy			1						1	Arthralgia; Asthenia; Glycosylated haemoglobin; Haematocrit decreased; Joint swelling; Red blood cell sedimentation rate normal; Vitamin D deficiency; White blood cell count normal	FLU3~SANOFI PASTEUR~U2524AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0989U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0302513	01/11/2008	IL	61.0	61		M	01/11/2008	Severe Headache the day following vaccine administation which lasted several days.  Severe case of Shingles starting December 1, 2007 which is just now starting to fade.  Patient has had Shingles in the past 2-3 times yearly for the last 10 years.  However, he states he has never been treated with antiviral medication.									Y	10/10/2007	10/11/2007	1		PUB	PVT	Medformin 1000mg BID for Diabetes Crestor 10mg da. for Cholesterol Nenapril 2.5 mg for Kidneys Numerous supplements	States was getting over a case of Shingles at time of vaccination.	Diabetes, Elevated Cholesterol;  Allergies to Prednisone and Celebrex			1						1	Condition aggravated; Headache; Herpes zoster	FLU3~SANOFI PASTEUR~U2494AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~074U~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0302516	01/11/2008	NY	0.09	0	.1	M	12/31/2007	Pt. was administered PediFlu at 5 wks of age in a misidentification medication error on 11/23/07. No adverse reaction detected at time of administration. Mother advised to watch for fever by M.D. Pt was reportedly admitted to hospital for evaluation. Unknown to health center if directly related to vaccination.  1/22/08 Reviewed hospital medical records which reveal patient experienced 3 episodes of becoming limp, floppy, pale, arching of back, abnormal movements of extremities, w/eyes rolling back followed by period of lethargy, decreased activity & reduced oral intake.  Seen at outlying ER & transferred to higher level of care.  Admitted 11/25-11/27/2007 for sepsis w/u.  Tx w/antiviral & antibiotic.  Neuro exam was WNL on admit.  (+) Gr III systolic murmur present.   FINAL DX: none provided on d/c summary. Follow-up: No contact with pt / mother since shortly after event.					Y	2			U	11/23/2007			None known LABS: WBC 16, H/H 7.4/22.6 (L), plts 381 (H), lymphs 59.1% (H), monos 14.4% (H), neutros 23.6% (L).  LP w/CSF: WBC 73, RBC 16,500, protein 109.3, glucose 60 (N).   Blood, urine & CSF c/s neg.  CT head WNL.  Video EEG WNL.	PUB	PUB	none					1						1	Inappropriate schedule of drug administration; Medication error	FLU3~SANOFI PASTEUR~UT2400AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0302517	01/11/2008	PA	4.0	4		M	01/12/2008	Influenza vaccine administered at well checkup 1/9/08 about 3:30pm.  Mom reports he became very fussy that night and had barky cough.  Neb treatment with Albuterol no help.  Next AM, more panic and screaming, seen in office by Dr., did have big inner ear infection but in more distress than expected, saying it's an emergency, I can't breath and in tears.  Difficult to console in office.  Given ear drops (acralfan), Motrin, and then Benadryl, finally about 10 min after Benadryl he fell asleep.  Patient seemed to be in a panic, which is out of character for him.  Sent home on Zithromax for ear infection and Benadryl every 6 hours.  (Exam showed no hives, no swelling, no wheezing, no respiratory distress but very panicked.)				Y					U	01/09/2008	01/09/2008	0		PVT	PVT	Albuterol as needed	None	Asthma, mild; possible Amoxicillin (rash) allergy			1						1	Abnormal behaviour; Cough; Emotional distress; Irritability; Labyrinthitis; Panic reaction; Screaming	FLU3~SANOFI PASTEUR~U2529AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0302520	01/11/2008	CA	3.0	3		F	01/11/2008	Flu vax given 1/3/08 afternoon, rash (papular) developed that night, itchy, low grade fever, spread and whole body. Treated at ED- tx'd wih Atarax, Prednisolone				Y					N	01/03/2008	01/03/2008	0	None	PUB	PVT	None	1/2/08 Vitamin of unknown etiology	None			1						1	Pruritus; Pyrexia; Rash generalised; Rash papular	FLU3~SANOFI PASTEUR~U2509AA~4~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0302534	01/11/2008	CA	61.0	61		F	01/11/2008	Patient describes since recieving flu shot on 12/11/07 she has been experiencing discomfort in her upper arm making it painful to move arm in certain directions.  She doesn't believe this is a normal reaction because she has had flu shots in the past with no difficulty.  She spoke to a pharmacist at a local pharmacy, not ours who stated that the needle may have punctured a vein or nerve.									U	12/11/2007				UNK	UNK	None on File	None noted	None Noted			1						1	Discomfort; Injected limb mobility decreased; No reaction on previous exposure to drug; Pain in extremity	FLU3~SANOFI PASTEUR~U2499AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0302555	01/13/2008	GA	16.0	16		M	01/13/2008	FOUR DAYS OF SEVERE FLU LIKE SYMPTOMS INCLUDING SEVERE HEADACHE, BODY ACHES, LOSS OF APPETITE, CHILLS, FEVER.									Y	01/07/2008	01/07/2008	0		UNK	UNK		N	NONE			1						1	Anorexia; Chills; Headache; Influenza like illness; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0302578	01/14/2008	FL	0.5			F	01/08/2008	Initial case received on 04 January 2008 from a health care professional.  A 6-month-old female patient had received a second dose injection of Fluzone No Preservative 2007-2008, lot number U2481GA, on an unknown date.  At an unknown time post-vaccination, the patient experienced a cerebrovascular accident requiring hospitalization.  A CT of the head, MRI, and spinal tap were performed, but results were not provided.  Past medical history, illness at the time of vaccination, and other medications were unknown.  The reporter considered the event to be life threatening.  Per the reporter, details were limited at this time.  At the time of this report, the patient had not recovered.			Y		Y	0			N				A CT of the head, MRI, and spinal tap were performed, but results were not provided.	PVT	OTH	Other medications were unknown	Illness at the time of vaccination unknown	Past medical history, illness at the time of vaccination, and other cerebrovascular accident requiring hospitalization. A CT of the head, MRI, and spinal tap were performed, but results were not provided. Past medical history, illness at the time of vaccination, and other medications were unknown. The reporter considered the event to be life threatening. Per the reporter, details were limited at this time. At the time of this report, the patient had not recovered.		200800025	1						1	Cerebrovascular accident; Lumbar puncture; Nuclear magnetic resonance imaging; Scan brain	FLU3~SANOFI PASTEUR~U2481G~2~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0302595	01/14/2008	MI	89.0	89		M	12/31/2007	8 hrs after vaccine admin., sudden onset of weakness bilateral arms & legs.  Difficulty with speech, swallowing & ineffective cough.  Overall sensation of feeling wet and burning flesh pain & paralysis.  Not recovered but some improvements seen.  2/8/08 Reviewed hospital medical records which reveal patient experienced arm & leg pain, slurred speech & right facial droop.  Admitted 12/13-12/29/2007.  Progressed to paresthesias & then paralysis.  Swallowing & urination compromised.  Neuro consult done & felt non reversible.  Transferred to hospice. FINAL DX: cervical cord compression 2nd to severe spinal stenosis; neuropathic pain in upper & lower extremities 2nd to cord compression. Annual Follow-up Information 18-FEB-2009: There was partial paralysis of the lower extremities that remained - unable to rehab pt. after receiving vaccine. Pt died approx 5 weeks ago (Jan 16) Sepsis due to bladder infection, being bedridden at nursing home and advanced age.  Pt. passed away 35 days after receiving this vaccine (Jan 16th 09). His residual symptoms were lower extremity (partial) paralysis. The upper extremity paralysis. Resolved shortly after initial onset but unable to rehab the lower lungs. Spots from bilateral infection had to hi.sdeath	Y	01/16/2009	Y	Y	Y	16	Y		N	12/12/2007	12/12/2007	0	CAT scan neg. for tumor or bleed LABS: head CT essentially WNL.  MRI c-spine revealed severe stenosis w/cord compression	PVT	UNK	Prednisone, metoprolol, aspirin, Vicodin, Lasix, lisinopril, K-DUR	None	Rheumatoid arthritis, degen. disk disease-cerv. neck PMH: RA, spinal deformities, steroid dependent.  Polymyalgia rheumatica. HTN.  HOH.  Compression fx of c-spine.  CAD, mitral regurgitation, CHF, cardiomyopathy w/CABG.  Ejection fraction 35%.			1						1	Burning sensation; Computerised tomogram normal; Dysphagia; Feeling abnormal; Muscular weakness; Pain; Paralysis	FLU3~SANOFI PASTEUR~U2525AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0302596	01/14/2008	MO	1.1	1	.1	F	01/09/2008	Febrile sz w/i 24 hours of 1 yr vaccines.  01/14/2008 VAERS report submitted with MR attached for ER visit 12/27 2007 with DX febrile seizure.  Child developed fever night of vax, went limp, vomited , then began shaking which last ~5-10 minutes.  Temp was 104. Returned to hospital with fever again 1/2/08, no seizure activity				Y	Y				Y	12/27/2007	12/27/2007	0	CBC, BMP, UA/flu, RSV all WNL. Labs and Diagnostics: CXR (-), CBC WNL, UA WNL, Chem unremarkable.  Cultures (-)	PVT	PVT			PMH: none. Had been pulling on ears day of vax. TMs OK. Teething. Family hx of seizures.			1						1	Febrile convulsion; Full blood count normal; Influenza serology negative; Metabolic function test normal; Urine analysis normal; Virus serology test	FLU3~SANOFI PASTEUR~UT2460EA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB171AA~1~IM~RL~HEP A (HAVRIX)~1|HIBV~SANOFI PASTEUR~VF217AA~3~IM~LL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0808U~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B54016D~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0302598	01/14/2008	GA	70.0	70		F	10/27/2007	Noticed two days post vaccine - C/O sore throat and no other symptoms - symptoms about two days and then improved - OK now.									Y	10/10/2007	10/12/2007	2		PUB	UNK	None	None	Asthma - no meds at present		GA07080	1						1	Pharyngolaryngeal pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80957~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0302611	01/14/2008	VA	42.0	42		M	01/14/2008	Employee reports flu shot was given Lt upper arm on 10/23/07. Employee reports he had pain at injection site LT upper arm with onset 3-4 day after the injection was given and this pain resolved after one week. Employee reports he then developed pain Lt Scapular area radiating to Lt Deltoid and Lt Bicep areas, rates pain was 6-7 on 1-10 scale. Employee also reports he had numbness and tingling to Lt thumb  lasting 2-3 weeks. Employee reports muscle soreness continues Lt Deltoid area, is not as severe and improves daily. EE reports numbness and tingling have resolved.  EE is a physician, self treated with massage, anti inflammatory and topical agents. Employee reports he is still using Topical cream that contains NSAID and feels this has given him the response. Ee denies wanting medical care for sx.									Y	10/23/2007	10/26/2007	3	None	UNK	UNK	None	None	None			1						1	Hypoaesthesia; Injection site pain; Musculoskeletal pain; Myalgia; Pain in extremity; Paraesthesia	FLU3~SANOFI PASTEUR~U2527AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0302612	01/14/2008	DC	4.0	4		F	01/14/2008	On the night of 1/9/08 the patient developed a red inflammed prurtic rash on the left upper arm. On exam, 1/10/08, the patient presented with an erythematous rash slight indurated on the left upper deltoid with no tenderness to touch noted and no heat. The patient was afebrile on the day of the exam. The patient was prescribed Benadryl 6.25 mg q8h prn for induration and pruritis on the left upper arm and hydrocortisone 2.5% topically BID prn to rash while present.									U	01/08/2008	01/09/2008	1	None ordered	UNK	UNK	none	none	caries			1						1	Inflammation; Injection site induration; Rash erythematous; Rash pruritic	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B067AA~UNK~IM~~DTAP (INFANRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500498~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~0073~UNK~IM~~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0869~UNK~IM~~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0302615	01/14/2008	IA	41.0	41		F	01/14/2008	Injection site became hot, swollen, and itchy one hour after injection.  Pt given ibuprofen 800 and Benadryl 25mg, this took care of the problem.									Y	11/01/2007	11/01/2007	0		UNK	UNK						1						1	Injection site pruritus; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~I2457CA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0302617	01/14/2008	NY	66.0	66		M	01/14/2008	Patient present to ECC with 2 day history of diplopia, dysequilibrium, headache, bad taste in mouth, upper extremity paresthesias and weakness, vertigo/dizziness.  Determined to have acute diffuse ocular motor palsy.  Over several days/weeks his ataxia an paresthesias worsen. Progression to worsening weakness, unable to open eyes, difficulty swallowing, descending paralysis. Many differential diagnosis ruled out via consult, lab work, imaging and physical exam.  Determined to have the Miller-Fisher variant of Guillain-Barre. Treated with plasmapheresis x6 treatments. Symptoms improve but patient continued to have issues with vision, speech, swallowing and weakness. Send to rehab for intensive physical, occupational and speech therapy. Patient continued to improve and was sent home to continue outpatient rehab. 1/15/08-records received for DOS 11/5-11/23/07-DC DX: Miller Fisher syndrome with ophthalmoplegia/ataxia/dysphagia. Presented to ED on 11/2/07 with C/P diplopia and ataxia.  Flu shot 10 days prior to onset of symptomalogy. After admission symptoms worsened and developed ophthalmopelgia, difficulty swallowing and clearing his secretions.  PEG placed.			Y	Y	Y	18			U	10/24/2007	11/01/2007	8	physical exam, AntiGQ1B, increase protein in Lumbar puncture 1/15/08-records received-MRI of brain revelaed old right basal ganglia lacunar infarct. Lumbar puncture mildy increased protein. Treated with plasmapheresis. CT unremarkable.	UNK	UNK	Lipitor, Altace, Aleve, Cymbalta, Aspirin	none	Allergies: Prednisone, turkey, shellfish. PMH: CAD, MI, TIA, Type 2 Diabetes, asthma, hypercholesterolemia, Prostate CA			1						1	Asthenia; Balance disorder; CSF protein increased; Diplopia; Dizziness; Dysgeusia; Dysphagia; Eye movement disorder; Headache; IIIrd nerve paralysis; Laboratory test; Lumbar puncture abnormal; Miller Fisher syndrome; Paraesthesia; Paralysis; Physical examination; Speech disorder; Vertigo	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80070~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0302622	01/14/2008	CA	55.0	55		F	12/19/2007	Patient states on 12//17/07 approximately 8:30 AM the injection site began to itch and swell.  By 6:00 PM, she felt flushed from her chest to her neck, weak, dizzy and had difficulty swallowing.  She took 50 mg Benadryl and called the paramedics who advised ER visit.  She was seen at hospital, given Claritin and Prednisone but still symptomatic				Y					Y	12/13/2007	12/17/2007	4	Unk	PUB	PUB	Unk	None	None stated		CA070042	1						1	Asthenia; Dizziness; Dysphagia; Flushing; Injection site pruritus; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA305BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0302623	01/14/2008	MI	9.0	9		M	01/08/2008	Onset redness at sight of SQ varicella inj (warm to touch) - 12/28/07.  Cont.  redness increasing in size with swelling approx size 11.5 cm x 14.5 cm.  Seen by Dr. on 12/31/07.  Placed on Keflex 500 tid.  1/1/08 symptoms resolving per patient mom.				Y					Y	12/28/2007	12/28/2007	0	None	PVT	PVT		None				1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2501AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB207AA~1~IM~RA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1343U~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0302627	01/14/2008	OK	0.6	0	.6	M	01/14/2008	Rash and hard bump on left thigh									Y	01/10/2008	01/11/2008	1	None	PVT	PUB		None	None			1						1	Injection site induration; Injection site rash	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B049AA~3~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2474EA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~0499U~3~IM~RL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~Z10692~3~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~B54013H~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0302628	01/14/2008	CA	1.4	1	.4	M		Rash around mouth and trunk.  Rash on right leg with blistering x approx. 3 days.  Pt had egg allergy causing allergic rash.  Prescribed Benadryl 6 mg by mouth every 6 hours and hydrocortisone 1% cream twice a day as needed.									U	01/03/2008	01/04/2008	1		PUB	PUB						1						1	Blister; Food allergy; Rash	FLU3~SANOFI PASTEUR~U2481FA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF218AB~4~IM~LL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~02870~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B54016H~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1581U~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0302630	01/14/2008	NE	0.8	0	.8	M	01/09/2008	Rotateq vaccine inappropriately administered at 40 weeks of age.  100.4 fever reporter by mom the day after vaccine administration.									Y	01/07/2008	01/08/2008	1		PUB	PUB		None	None known			1						1	Inappropriate schedule of drug administration; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B126BB~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2442AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B53981H~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0902U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0302632	01/14/2008	NC	10.0	10		F	01/09/2008	2 inch x 3 inch red indurated area back of right arm.  Warm & tender.  Treatment ice, Benadryl 25 mg orally at bedtime, Benadryl gel topically during school.									U	01/07/2008	01/08/2008	1		PUB	PUB	Bicillin 1.2 million units IM on 1/7/08.	(+) RST - strep throat	allergy (red dye in foods)			1						1	Induration; Skin warm; Tenderness	FLU3~SANOFI PASTEUR~U2508AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB225BB~1~IM~RA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~1060U~1~IM~LA~HPV (GARDASIL)~1|VARCEL~MERCK & CO. INC.~1496U~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0302634	01/14/2008	GA	74.0	74		M	10/17/2007	C/O sore throat, congestion, and cough - Improved but still with cough.  No fever.									Y	10/10/2007	10/12/2007	2		PUB	UNK			2003 - Heart attack and bypass		GA07081	1						1	Cough; Pharyngolaryngeal pain; Respiratory tract congestion	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80957~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0302636	01/14/2008	GA	25.0	25		M	11/15/2007	Redness around injection site, rash developed.  Client c/o itching without relief after taking Benadryl.  Saw MD 11-15-07, gave him a shot for itching and a Rx for Motrin & Benadryl.				Y					Y	11/13/2007	11/13/2007	0	None	OTH	PVT		None	None		GA07083	1						1	Injection site erythema; Injection site rash; Pruritus	FLU3~SANOFI PASTEUR~PMCU2524AACP~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0302643	01/14/2008	MI	1.0	1	.0	M	01/17/2008	Patient's mother reports that she noticed Non-Raised Red Rash Started on patient's Torso, with patient feeling general malaise, flu-like symptoms - took child to their Pediatrician no other treatment given				Y					Y	12/20/2007	12/30/2007	10	None	OTH	PUB	None	None	Not aware	none~ ()~~0.00~In Patient|none~ ()~~0.00~In Sibling		1						1	Erythema; Influenza like illness; Malaise; Rash	FLU3~SANOFI PASTEUR~U2523AA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0284U~1~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1338U~1~UN~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0302648	01/14/2008	LA	62.0	62		F	11/19/2007	Patient reports headache, nausea stomach upset along with weakness seen at medical center 11/19/07 - Reports M.D. said unsure if reaction from flu and patient was released; 12/20/07 F/U all made and patient fully recovered.				Y					Y	11/16/2007	11/17/2007	1		PUB	PUB		none	none			1						1	Asthenia; Headache; Nausea; Stomach discomfort	FLU3~SANOFI PASTEUR~U2487AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0302653	01/14/2008	GA	17.0	17		F	11/07/2007	Client received Influenza vaccine 10/29/07.  Reported to HD 11/7/07 after office visit with MD.  Stated she started with rash on her abdomen 11/2/07 that looks like small mosquito bites.  Continued to spread.  Hives type rash noted on abdomen and pelvic area today with itching.  Was put on Medical Doze Pack by MD.  Denies allergies to eggs.  Client to discuss with her allergist prior to next flu shot.				Y						10/29/2007	11/02/2007	4	None	PUB	PUB	None	None	Respiratory allergies			1						1	Pruritus; Rash; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80958~7+~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0302668	01/14/2008	NC	67.0	67		F		11-9-07 AM shot for flu - at injection felt as if given a double dose. Got sore that day. Next morn could not raise arm to side up. Back to doctor, given large dose of pain med. Didn't stop pain. Arm still in pain. As of 1-2-08 Arm still sore small amt of pain, but arm still not able to raise up to side or back without pain.									U	11/09/2007	11/09/2007	0		PVT	OTH	Naproxen 500 mg tablets; Prosoxyphene 100	None	None			1						1	Injected limb mobility decreased; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79238~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0302669	01/14/2008	AL	1.3	1	.3	F	01/09/2008	Fever/cough (mother insist symptoms were from flu shot)									Y	12/17/2007	12/24/2007	7	Blood test all normal; Chest and neck x-rays=Normal	PVT	PUB		none	none			1						1	Blood test normal; Chest X-ray normal; Cough; Pyrexia; X-ray normal	DTAP~GLAXOSMITHKLINE BIOLOGICALS~~4~UN~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2523AA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z1009~3~UN~LL~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0302796	01/14/2008	TX	4.0	4		M	12/18/2007	A serious report of Henoch-Schonlein purpura and intussusception, status post reduction was received from a study investigator concerning a four-year-old male, who is enrolled in a trial. The patient had a medical history that consisted of episodes of bright red blood in the stool which occurred on 18-Oct-2007; bilateral pedal edema and macular rash over the lower extremities and buttocks for which he was seen in the emergency room on 25-Nov-2007. Concomitant medications were not reported. The subject received FluMist intranasally on 10-Nov-2007 for influenza immunization. On 25-Nov-2007, the subject was seen in the emergency room for bilateral foot swelling/pain with a rash that spread from feet to groin. Physical examination confirmed bilateral pedal edema and macular rash over his lower extremities and buttocks. Laboratory evaluation which consisted of sedimentation rate, complete blood count (CBC) with differential, liver function enzymes, blood urea nitrogen (BUN), urine analysis were within normal values. Impression was that of hypersensitivity vasculitis. A diagnosis of Henoch-Schonlein purpura was made on 26-Nov-2007 when he was re-evaluated for his rash. From 01-Dec-2007 to 02-Dec-2007, he was hospitalized for abdominal pain and vomiting secondary to Henoch-Schonlein purpura. Ultrasound and gastrografin enema were negative for intussusception and other pathology. His laboratory results were normal except for his white blood cells (WBC) count of 13.7 and a 4+ ketones in his urine on admission. His discharge diagnoses were : Henoch-Schonlein purpura, and abdominal pain and dehydration. He was re-hospitalized from 08-Dec-2007 to 10-Dec-2007 because of blood in the stools, severe abdominal pain and bilious emesis. An air enema revealed intussusception in the upper part of the ascending colon which resolved during the procedure. Abnormal laboratory results include : WBC= 22.1; red blood cell (RBC) count = 6.01; hemoglobin = 14.9; hematocrit; platelet = 508; granulocyte = 851; lymphocyte; serum glucose = 140; serum creatinine = 0.11; serum sodium = 131; serum potassium = 5.6; serum albumin = 3.5; urinalysis showed protein = 30, 1+ blood. RBC = 3.9, ccasional mucous and amorphous crystals. He was observed for three days without complications except for one episode of painless bloody stool. His discharge diagnoses were Henoch-Schonlein purpura and intussusception, reduced. The subject was discharged home on prednisolone 15 mg twice daily for three days followed by a tapering regimen over six days, and lansoprazole 15 mg daily. The subject recovered from both events. The subject did not experience a rechallenge while receiving the study vaccine. The investigator assessed causality for the events as not related to FluMist.					Y	2			Y	11/10/2007	12/01/2007	21	Ultrasound and gastrografin enema - negative for intussusception and other pathology; Albumin, 18/08/07, 3.5 gm/dL; Blood in Urine, 12/08/07, 1+, Neg; BUN, within normal values; CBC with differential, within normal values; creatinine, 12/08/07, 0.11 mg/dL, within normal values; Glucose, 12/08/07, 140 mg/dL; Gran #, 12/08/07, 19.01; Granulocyte, 12/08/07, 85%; HCT, 12/08/07, 44.1; HGT, 12/08/07, 14.9; liver function enzymes, within normal values; Lymph %, 12/08/07, 7%; MCH, 12/08/07, 24.8; MCV, 12/08/07, 73.4; Mono #, 12/08/07, 1.55; Platelet, 12/07/07, 508; Potassium, 12/08/07, 5.6 mEq/L; RBC, 12/08/07, 6.01; RBC in Urine, 12/08/07, 3.9; sedimentation rate, within normal values; Sodium, 12/08/07, 131 mEq/L; Urine Amorphous Crystals, 12/08/07, occasional; Urine Mucous, 12/08/07, occasional; Urine Protein, 12/08/07, 30; WBC, 12/01/07, 13.7; 12/08/07, 22.1; an air enema revealed intussusception in the upper part of the ascending colon which resolved during the procedure.	OTH	OTH	Concomitant Drug(s) Not Reported		Blood in stool; Pedal edema; Macular rash		MEDI0006329	1						1	Abdominal pain; Barium double contrast; Blood albumin decreased; Blood creatinine normal; Blood glucose increased; Blood potassium increased; Blood sodium decreased; Blood urea normal; Blood urine present; Dehydration; Differential white blood cell count normal; Full blood count normal; Haematochezia; Haematocrit increased; Haemoglobin increased; Henoch-Schonlein purpura; Intussusception; Leukocytoclastic vasculitis; Liver function test normal; Lymphocyte percentage decreased; Mean cell haemoglobin decreased; Mean cell volume abnormal; Monocyte count decreased; Oedema peripheral; Pain in extremity; Platelet count increased; Rash macular; Red blood cell count increased; Red blood cell sedimentation rate normal; Ultrasound scan normal; Urine analysis normal; Urine ketone body present; Vomiting; White blood cell count increased	FLUN3~MEDIMMUNE VACCINES, INC.~500491P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0302797	01/14/2008	FL	36.0			M	12/13/2007	A nonserious report of chest congestion, coughing with phlegm, night sweats, nasal congestion, lip swollen, and poor appetite has been received from a consumer concerning her son, a three-year-old male. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age Flumist. No medical history nor concomitant medication were provided. The patient received Flumist on 07-Dec-2007. On 08-Dec-2007, the child experienced chest congestion, coughing with phlegm, night sweats, nasal congestion, lip swollen, and poor appetite. No outcome for the events was provided by the reporter; although the symptoms were reported to be somewhat better. The patient did not experience a rechallenge while receiving the suspect product. The reporter provided no causality assessment for the events. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to MEDI-0006289, a report for the patient's mother.									U	12/07/2007	12/08/2007	1		MIL	OTH	Concomitant Drug(s) Not Reported				MEDI0006287	1						1	Decreased appetite; Lip swelling; Night sweats; Productive cough; Respiratory tract congestion	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0302798	01/14/2008	CO	1.5			M	12/14/2007	A non-serious report of an 18-month old female who received FluMist by accident was received from a consumer.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  No medical history nor concomitant medications were provided.  The patient received FluMist on 14Dec2007.  The 18-month-old patient was inadvertently administered FluMist.  No other events were reported.  No outcome for the event was provided by the reporter.  No dechallenge or rechallenge occurred.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U	12/14/2007	12/14/2007	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0006307	1						1	Wrong drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0302799	01/14/2008	LA	3.0	3		F	12/05/2007	A non-serious report of twitching in eye has been received from a physician concerning a three-year-old female.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  The patient, adopted, had no medical conditions and took no concomitant medications.  The patient received FluMist on 26-Nov-2007.  The physician stated the father reported on the day the patient received FluMist, twitching of the child's eye started.  The twitching continued at the time of this report.  Additional dosing with FluMist is not applicable.  The reporter did not provide a causality assessment for the adverse event reported.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									N	11/26/2007	11/26/2007	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0006244	1						1	Eye disorder; Muscle twitching	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0302800	01/14/2008	MD				U		A non-serious report of inappropriate dose of vaccine administered was received from a nurse in the concerning a patient of an unknown age.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  No relevant medical or drug history information was reported.  The infant was given FLUMIST on an unknown date.  The patient received one full dose of FLUMIST in each nostril.  No adverse events were reported from this error.  The reporter indicated that there would be no additional information available.  Rechallenge is not applicable.  Causality assessment is not applicable.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  12-Dec-2007: Follow up information obtained and incorporated in above narrative: Availability of information.08-Jan-2008: Follow up information obtained and incorporated in above narrative: Clinical outcome.									U					UNK	UNK	Concomitant drug(s) not reported		None		MEDI0006240	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0302801	01/14/2008	MD				U	12/04/2007	A non-serious report of two doses of FluMist given on same day has been received from a nurse concerning a child of unknown age.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for newly indicated population of 2 years to 59 months of age for FluMist.  No medical history no concomitant medications were provided.  The patient received FluMist on an unknown date.  The school age child received one full dose of FluMist in each nostril.  No adverse events were reported.  No outcome was provided by the reporter.  The patient did not experience a rechallenge while receiving the suspect product.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  This case is linked to MEDI-0006238 and MEDI-0006240 which were all received from the same reporter.									U					OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0006239	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0302802	01/14/2008	MD				U	12/04/2007	A non-serious report of two doses of FluMist given on same day has been received from a nurse in the USA concerning a child of unknown age.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  No medical history nor concomitant medications were provided.  The patient received FluMist on an unknown date.  The school age child received one full dose of FluMist in each nostril.  No adverse events were reported.  No outcome was provided by the reporter.  The patient did not experience a rechallenge while receiving the suspect product.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  This case is linked to MEDI-0006239 and MEDI-0006240 which were all from the same reporter.									U					OTH	OTH	Concomitant Drug(s) not reported		None		MEDI0006238	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0302803	01/14/2008	NY	2.0			F	12/19/2007	MEDI-0006332 is a non-serious case received from a physician of inadvertent administration of Flumist to a two-year-old female with a history of wheezing.  The patient has a history of recurrent wheezing and no concomitant medications were reported.  On 19 Dec 2007, the patient was inadvertently administered a Flumist vaccine.  The reporter indicated that the patient had not experienced any events at the time of the report.  No further information was provided.  The outcome of the event is unknown.  Rechallenge is not applicable.  The reporter did not provide a causality statement for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U	12/19/2007	12/19/2007	0		PVT	UNK	Concomitant Drug(s) Not Reported	Wheezing			MEDI0006332	1						1	Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0302718	01/15/2008	MI	56.0	56		U	01/15/2008	Left arm painful and inflamed since injection; could not lift arm above level of shoulder nor rotate arm; called PCP and was advised ice, ibuprofen and later added massage therapy.  Pain moved up arm and into shoulder by this time.  Massage therapy X 4-5 weeks with improvement but still having problems lifting arm or full range of motion.  Has improved but not returned to normal levels of activity at this time 1/15/2008.				Y						10/23/2007	10/23/2007	0	None	UNK	UNK						1						1	Inflammation; Injected limb mobility decreased; Musculoskeletal pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2488AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0302719	01/15/2008		38.0	38		F		Throat and mouth was swollen eye were red and had discharge coming from them. 4/21/08-office notes received for 12/13/07-C/O tongue and throat swelling. Dyspnea. DX: Anaphylaxis uncertain exact allergen. Symptoms began 3 hours after vaccination.			Y	Y					Y	12/13/2007	12/13/2007	0		MIL	MIL	None	None	4/21/08-asthma			1						1	Eye discharge; Eye swelling; Ocular hyperaemia; Oedema mouth; Pharyngeal oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA049AA~3~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening	Influenza
0302726	01/15/2008	OR	52.0	52		F	11/30/2007	For 48 hours after immunization, patient was bedridden both mentally and physically very weak.  Arm showed bruising and inflammation.				Y					Y	11/27/2007	11/28/2007	1		OTH	PVT	Singulair					1						1	Asthenia; Bedridden; Contusion; Inflammation	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA025AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0889F~1~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0302731	01/15/2008	CA	19.0	19		F	12/01/2007	1st day, evening sore throat, cough continuing with headache chills and ear ache.  2nd day with body ache.  3rd day all symptoms continuing with temperature 99.3 and increasing, difficulty breathing, wheezing and heart missing beats and some fast beats and chest pains and dizziness in the evening.  Tool Tylenol and albuterol for breathing.  4th day, breathing and heart better, sore throat, cough and head congestion.  8th day, doctor gave amoxicillin for next 7 days and nasal decongestant.									Y	11/02/2007	11/02/2007	0	Checked by doctor at Student Health Center 11/9/07.	PUB	OTH	Microgestin Fe 1/20 daily, Albuterol as needed.	None	Congenital heart defect and surgically repaired, IGA immune deficiency, asthma.			1						1	Body temperature increased; Chest pain; Chills; Cough; Dizziness; Dyspnoea; Ear pain; Headache; Heart rate irregular; Nasal congestion; Pharyngolaryngeal pain; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0302732	01/15/2008	NY	4.0	4		M	01/10/2008	Mom called on 1-2-08 to state that 2 weeks after vaccines he woke crying and seemed startled & limber.  Stated in '05 he had a fever for 2 days about 2 weeks after his first flu shot.  No documentation.  Child was not seen after either episode.									Y	11/16/2007			None	PVT	PVT	None	None	Febrile seizure at 19 mo.			1						1	Agitation; Crying	FLU3~SANOFI PASTEUR~U2524AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0298~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0302734	01/15/2008	NY	13.0	13		M	01/09/2008	Varicella given Left deltoid IM instead of subcutaneous.									Y	01/03/2008			None	PVT	PVT	Concerta	None	ADD, PDD			1						1	Incorrect route of drug administration	FLU3~SANOFI PASTEUR~U2505AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B024CA~UNK~IM~UN~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1561U~2~IM~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0302737	01/15/2008	TX	28.0	28		F	01/10/2008	Approximately 10 minutes after receiving MMR, hepatitis B & influenza vaccines employee felt thick tongued & loopy.  Loopy feeling lasted about 30 minutes. Thick-tongued for 1 hour.  History of several allergies (food, seasonal allergies & Type I, latex allergy).									U	01/09/2008	01/09/2008	0		PVT	PVT	None	None	None diagnosed by physician.  History of several allergies (food, seasonal allergies & Type I, latex allergy).			1						1	Feeling abnormal; Tongue disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA319AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~MERCK & CO. INC.~1148U~1~IM~RA~HEP B (FOREIGN)~1|MMR~MERCK & CO. INC.~0418U~3~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0302741	01/15/2008	IN	30.0	30		F	01/08/2008	By about 9:00 pm, the night the flu mist was given, I started throwing up, shaking, migraine headache, then hives showed up by next morning.  Hives lasted 3 days.				Y					Y	12/01/2007	12/01/2007	0		MIL	UNK	None	Cold	Hay fever			1						1	Migraine; Tremor; Urticaria; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500477P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0302744	01/15/2008	LA	59.0	59		F	10/05/2007	Patient received Pneumonia vaccine 10/1/07. Reported to ER; 10/2/07 swelling and redness to Right arm				Y					Y	10/01/2007	10/02/2007	1		PUB	PVT		none reported	none reported			1						1	Erythema; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78478~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0961U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~MASS. PUB HLTH BIOL LAB~Td-169~UNK~IM~LA~TD ADSORBED (TDVAX)~1	USA	Emergency room visit	Influenza
0302753	01/15/2008	TX	65.0	65		M	01/15/2008	PATIENT DEVELOPED SEVERE JOINT PAIN A COUPLE OF DAYS AFTER VACCINE WAS ADMINISTERED.  PATIENT EVENTUALLY WAS ADMITTED TO HOSPITAL WITH NO PLATELETS.  WAS IN HOSPITAL UNTIL PLATELETS RESTORED. MD AND HEMATOLOGIST BELIEVE THAT FLU SHOT STARTED THE CASCADE OF EVENTS.  03/21/2008  MR received for DOS 12/16-23/2007 with D/C DX:  Severe Thrombocytopenia, presumed ITP. Pt presented to local ER with c/o several day hx of bleeding mouth sores and melena. Platelet count noted to be 0 (zero) and pt transfered to current facilty for eval and tx. PE (+) for purpuric raised rash on arms, submucosal bleeding and black pigmented rash noted in mouth, on tongue and lips.  Pt txd with Solumedrol, IVIG and platelet transfusions. D/C to home on prednisone				Y	Y	7			Y	10/29/2007	10/31/2007	2	Labs and Diagnostics:  CBC with platelets 2,000-up to 33,000 by D/C, WBC 5.9, Hgb 10.9, Hct 32.3-down to 22.9 and up to 33.9 by d/c. PT 15.8. Glucose 168. Colonoscopy normal.	UNK	UNK			PMH: hyperlipidemia, allergic rhinitis, seasonal allergies, osteoarthritis, DJD, CAD with cardiac cath in 1998, hypothyroidism, perineal abscess. NKDA. Pt recently started on Cymbalta and Ambien CR for sleep difficulty with depression.			1						1	Arthralgia; Platelet count decreased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79238~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0302759	01/15/2008	CA	58.0			M	01/15/2008	Fever 3 days after administration; followed by profound unilateral hearing loss 12/10/2007. 3/26/08-records received-for DOS 12/10/07-Complete loss of hearing left ear, onset uncertain.  DX: conductive hearing loss unilateral. Migraine.								Y	N		12/09/2007		Audiology 3/26/08-records received-CRP 3.5.	UNK	UNK			3/26/08-records received-HX of tinnitus for years, Hx of frequent headaches, takes 3 aspirins per day until gastroenterologist advised reducing amount of aspirin intake due to esophageal ulcerations.			1						1	Audiogram; Deafness unilateral; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Disabling	Influenza
0302761	01/15/2008	AR	2.0	2	.3	F	01/05/2008	Rash began on Thur am around injection site on leg going to mid thigh.  By Friday pm still same.  By Saturday am all over body of arms, legs, face and bottom bright red, hot to the touch and itchy.  Patient miserable from listing above.  Treated with Benadryl, 3 ml every 6 hours.  Did for 3 days.				Y					Y	01/02/2008	01/03/2008	1	Doctor visit, ran strep test to make sure not strep rash, came back negative, but felt since it stemmed from injection site related to flu vaccine.	PVT	OTH	None	None	None			1						1	Feeling abnormal; Injection site rash; Pruritus; Rash generalised; Streptococcal identification test negative	FLU3~SANOFI PASTEUR~U2435~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0302762	01/15/2008	AZ	5.0	5		M	01/10/2008	3 1/2 x 5 cm redness and induration, painful and warm to the touch.									Y	01/08/2008	01/09/2008	1	None	PVT	PUB	None	None	None			1						1	Erythema; Induration; Pain; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80956~3~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0962U~1~SC~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0302763	01/15/2008	OR	65.0	65		F	01/08/2008	Rash all over face and front of neck starting the night of immunization. Patient took Benadryl									Y	12/27/2007	12/27/2007	0		OTH	OTH	Lysine, Vitamin E, Centrum Silver	No	None			1						1	Rash	FLU3~SANOFI PASTEUR~U2497AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0302764	01/15/2008	RI	15.0	15		M		Patient Recived Immunizations Below approximately 510pm. Returned to clinic approximately 610pm complained of swelling around both eyes and diff breathing through nose no shortness of breath no swelling of lips				Y					U	01/10/2008	01/10/2008	0		PUB	PUB		No	No			1						1	Dyspnoea; Eye swelling	FLUN3~MEDIMMUNE VACCINES, INC.~500482P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U2430AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B021CB~UNK~IM~LA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1563U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0302767	01/15/2008	NC	1.28	1	.3	F	12/21/2007	Approximately, 14 hours after Immunizations: Child had acute onset of prolonged seizures activity was transported to hospital ER (in ambulance) then Life Lifted to another hospital. Approximately 24 hours of coma - no vent support.					Y	3			Y	12/13/2007	12/14/2007	1	MRI-results positive	PVT	OTH						1						1	Coma; Convulsion; Nuclear magnetic resonance imaging abnormal	DTAP~SANOFI PASTEUR~U2289AA~4~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2508AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0079U~3~IM~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B08700B~6~IM~LL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0302770	01/15/2008	MD	65.0	65		F	01/10/2008	Sore throat turned into a head cold and cough.  Took over the counter medication but symptoms came back.  On 11/17 visited doctor who gave medication for wheezing, chronic bronchitis and hoarseness.  Began treatment with Azythromicin, Benzonate, Prednisone, Nasanex.  Days later general practitioner confirmed diagnosis.  1/9/07 visited doctor for recurring sore throat, wheezing in center of chest, prescribed antibiotic (cephalexin).				Y					U	10/25/2007	10/28/2007	3	X-rays to diagno chronic bronchitis.	OTH	PUB	Hydrochlorothiazide, Centrum	No	High blood pressure			1						1	Bronchitis; Bronchitis chronic; Chest X-ray; Cough; Dysphonia; Nasopharyngitis; Pharyngolaryngeal pain; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0302805	01/16/2008	MI	1.0	0	1	M	01/08/2008	Idiopathic Thrombocytopenia Purpura platelet count 8,000. Following WinRho platelet count recovered to 234,000.  1/22/08 Reviewed pcp medical records which reveal patient experienced rash x 3 days when seen 12/31/07 w/o fever or other signs of illness.  Exam revealed petechia on extremities, trunk & back & multiple purple bruises on shins & left forehead.  Labs done revealed decreased plts.  Hospitalized 12/31/07-1/1/08 & received WinRo.  Plts increased from 8,000 to 58,000 & microscopic hematuria improved.  Consult by peds heme/onc while hospitalized.  Plts count repeated on visit 1/4 & were 234,000.  Having mild diarrhea & diaper rash.  Petechia & bruises were resolving.  Was to continue serial labs & heme/onc f/u. FINAL PCP DX: ITP, resolving; anemia secondary to WinRo. 1/22/08 Reviewed hospital medical records which reveal patient experienced rash, bruising, irritability & sleepiness x 3 days.  Transient diarrheal illness in pt & parents 1-2 wks & URI 1 mo prior to admit.  Both parents w/viral URI.  Admitted 12/31/07-1/1/08.  Responded well to WinRo & d/c to home w/heme  & lab f/u. FINAL DX: Immune thrombocytopenic purpura & benign hyperalkaline phosphotase (qcquired vx familial), microscopic hematuria, resolving.					Y	2			Y	11/30/2007	12/28/2007	28	Platelet count decreased to 8,000 LABS: WBC 7.8, plts 9,000 on admit, 58,000 at d/c, differential WNL.  BUN/creat ratio 62 (H), alk phos 3518 (H), LD/LDH 445 (H).  UA w/RBC & WBC, pH 8.0 (H), c/s neg.	PVT	PVT		cold symptoms approx 1 mos	PMH: full term, c-section, jaundice at birth tx w/phototx.  Mother GBS (+).  Family hx of diabetes.  Had roseola in past.			1						1	Idiopathic thrombocytopenic purpura; Platelet count decreased	FLU3~SANOFI PASTEUR~UT2480AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB207BA~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0527U~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1473U~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0302814	01/16/2008	CA	0.3			F	01/14/2008	Seriousness criteria: other-medically significant.  Initial case was received on 02 January 2008 from a health care professional affiliated with an organization under reference number 0712031485, who received this information from the patient's parent.  A 4-month-old female infant with no reported medical history, had experienced a seizure 397 days after she had received a transplacental dose of influenza vaccine (manufacturer and lot number not reported) on 01 October 2006.  The infant's reported date of conception was 11 September 2006.  The infant had also received the following concomitant medications transplacentally which consisted of Arava 20 mg q.d., prenatal vitamins q.d., and an iron supplement q.d.  The infant was born full-term on 02 June 2007.  The infant's mother had a past history of anemia which was diagnosed during childhood and rheumatoid which had been diagnosed when she was 18 years of age.  The mother of the infant reported that the infant had three seizures.  On (approximately) 02 November 2007, 397 days after receiving the vaccine, the infant experienced a seizure.  On 23 December 2007, the mother reported that the infant started shaking, her eyes rolled back and she began vomiting.  The infant was taken to the emergency room and was positive for a urine infection.  The infant was not admitted to the hospital.  On 01 January 2008, the mother reported that the infant had been shaking a lot and that the infant hit her head.  At the time of the report, the infant had not been fully evaluated by a physician and their recovery status was not provided.  The reporter for this case (infant case) is the same as was reported for case number 2008-00066 (no adverse effect for the mother).				Y					U		11/02/2007		Not reported	UNK	UNK	Arava, iron, prenatal vitamins		The patient's mother had a history of anemia diagnosed during childhood and rheumatoid which was diagnosed at 18 years of age.		200800045	1						1	Convulsion; Drug exposure during pregnancy; Gaze palsy; Head injury; Tremor; Urinary tract infection; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0302819	01/16/2008	IL	5.0	5		M	01/14/2008	Initial report received from a health care professional on 02 January 2008. A five-year-old male patient with a medical history of sulfa allergy, as well as a cough at the time of vaccination, received a dose of Fluzone SV 2007-2008, lot number U2531AA, in the deltoid with a 3/8 inch needle on 27 December 2007. One day later, on 28 December 2007, the patient developed redness and swelling at the injection site that spread to his chest area. He was treated with Keflex and Motrin. He developed a fever of 101 degrees Fahrenheit and became progressively worse throughout the evening. He was admitted to the hospital (date not reported). It is unknown whether any laboratory testing was completed. The patient was reported to have spent two to three days in the hospital and may have been discharged on 31 December 2007. The patient recovered from the events.					Y	0			Y	12/27/2007	12/28/2007	1	Unknown	PVT	UNK		At the time of vaccination on 27 December 2007, he had a cough.	The patient has a history of allergy to sulfa drugs.  He had received an influenza vaccine the previous year.		200800008	1						1	Erythema; Injection site erythema; Injection site swelling; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U2531A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0302823	01/16/2008	MI	52.0	52		F	12/13/2007	Developed itchy B-B size elongated bumps on arms & legs evening of 12-12-07.  Throat is scratchy but no difficulty breathing.  Bumps are not red.  Advised medical care.				Y					U	12/11/2007	12/12/2007	1	None	PUB	PUB		None	Allergies penicillin, sulfa, red dye, multiple foods, Ceclor	None~ ()~~0.00~Patient	MI2008002	1						1	Rash; Rash pruritic; Throat irritation	FLUX~SANOFI PASTEUR~U2526AAC~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB173AA~1~IM~LA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0302825	01/16/2008	MO	58.0	58		F	01/16/2008	The 58 y/o pt presented first to the clinic on 1/9/08, for complaint of left upper arm pain following influenza vaccination on 12/13/07. On return visit on 1/16/08, she states that the pain has been decreased since last visit. The pain is still  located on the left deltoid area. The pain is dull ache pain in nature. She scored the pain at 2-3/10. The pain is slightly aggravated by elevating and moving the left arm. She denies any fever, chills.   She denies any sensation difficulties in her left arm and left hand. She also denies history of any insect bite and any injury in that area.									N	12/13/2007	12/13/2007	0	Physical Exam  The left deltoid area appears no deformity, no erythema, no skin broken down. There is mild tenderness in left deltoid muscle to deep palpation. The ROM of right shoulder is within normal limits. There are no sensation deficit in left arm and left hand.	UNK	UNK	Simvastatin Levoxyl Omeprazole	None	Skin Cancer on face and scalp Hypothyroidism Hyperlipidemia GERD			1						1	Injected limb mobility decreased; Injection site pain; Pain in extremity; Tenderness	FLU3~SANOFI PASTEUR~U2523AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0302826	01/16/2008	LA	0.5	0	.5	F	01/07/2008	This is a 6-month old white female who was transferred from the emergency room when she came into cardiac arrest on full code, asystole and was resuscitated and the heart rate was brought back after several minutes.  According to the mother, she left the child prone over a blanket that had the four ends secure so it would not fold and left the room.  She had heard the baby cry because, according to her, she didn't like to be prone.  She heard the baby cry 5 minutes before she went back into the room and found her completely unresponsive.  She started CPR and called the paramedics who arrived in another 5 minutes according to her.  They intubated the baby and transferred to the emergency room.  From there, the patient was sent to this PICU.  The physical examination showed the baby to be unresponsive to stimuli with gasping rhythmic chest movements with no effective ventilation.  The pupils were at 5 mm and fixed.  The patient was on the respiratory oxygenating well.  The capillary refill was fair to poor approximately 4-5 seconds.  Air entry was good and the heart was rhythmic with no murmur.  The abdomen was soft.  There were no bruises on the body or head of the infant.  There was no gag reflex.  A CT scan done at the emergency room showed no bleeding or edema with normal ventricles.  The patient was placed on mechanical ventilation.  A femoral line was placed.  The baby was also started on Dopamine and Dobutamine for low blood pressure and poor perfusion and responded well to it.  The baby also received albumin 5%.  Due to the fact there was no cerebral edema, no Mannitol or 3% saline was given.  The venous blood gases showed normal oxygenation and ventilation.  The next day, repeat CT scan still did not show any brain edema or hemorrhage.  An EEG was nearly flat that day with no significant cortical activity.  Over the next 24 hours, the patient had at one point, according to some nurses, some very sluggish pupil reaction and even very mild response to deep pain in the lower extremities only.  In my examination, basically the pupils were nonreactive and there was no response to pain.  Over the next 24 hours, the agonal respirations disappeared.  The EEG became completely flat and there were no signs of any brain activity.  At that point, the situation was discussed with the parents and they agreed to an apnea test which showed the patient to have no spontaneous respirations despite the PCO2 going up to 77 and the oxygen saturation dropping to below 70.  Also, at that point, there was no corneal reflex.  The ocular vestibular reflex was negative.  There was no gagging or coughing reflex, and there was no response to deep pain in any form including unchanged heart rate and blood pressure.  The baby had a brain flow scan shortly after she came to the PICU, and it showed blood flow to the brain.  After the apnea test and the rest of the examination for brain death was done, the mother requested a second brain flow study.  The brain flow study was equivocal but still showed flow.  Despite that, I explained to the mother that the criteria was still met for brain death, especially if the patient had not received any narcotics or any medications that could be impairing the cortical brain stem activity.  At that point, I placed a call to another doctor who came and examined the patient and concurred there was brain death.  The mother discussed the case with organ donation personnel and decided to donate the daughter's organs.  The care was then transferred to organ donation on 12/24/07.  Final diagnosis: 1. acute life threatening event, 2. anoxic encephalopathy, 3. brain death.  9/9/06 Autopsy report states COD as probable apneic event w/history of anoxic encephalopathy, unresponsiveness, resuscitation & hospitalization, neuro delay & no evidence of trauma or injury.	Y	12/24/2007							N	12/20/2007	12/22/2007	2	A CT scan done at the emergency room showed no bleeding or edema with normal ventricles.  The next day, repeat CT scan still did not show any brain edema or hemorrhage.  An EEG was nearly flat that day with no significant cortical activity.  Over the next 24 hours, the agonal respirations disappeared.  The EEG became completely flat and there were no signs of any brain activity.  an apnea test which showed the patient to have no spontaneous respirations despite the PCO2 going up to 77 and the oxygen saturation dropping to below 70.  Also, at that point, there was no corneal reflex.  The ocular vestibular reflex was negative.  There was no gagging or coughing reflex, and there was no response to deep pain in any form including unchanged heart rate and blood pressure.  The baby had a brain flow scan shortly after she came to the PICU, and it showed blood flow to the brain.  After the apnea test and the rest of the examination for brain death was done, the mother requested a second brain flow study.  The brain flow study was equivocal but still showed flow.  Despite that, I explained to the mother that the criteria was still met for brain death, especially if the patient had not received any narcotics or any medications that could be impairing the cortical brain stem activity.  An autopsy was performed.	PVT	PUB	None	None	Unremarkable. There were no previous hospitalizations. She has received the six month immunizations two days before this happened and has been told the baby needed tummy time to develop the trunk tone and that is what she was doing when this happened.			1						1	Anoxic encephalopathy; Apnoea test; Autopsy; Brain death; Brain scan normal; Cardiac arrest; Computerised tomogram normal; Corneal reflex decreased; Crying; Dyspnoea; Electroencephalogram abnormal; Hypotension; Intensive care; Intubation; Mechanical ventilation; Oxygen saturation decreased; PCO2 increased; Poor peripheral circulation; Pupil fixed; Respiratory disorder; Resuscitation; Unresponsive to stimuli	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B137AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2514AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B54016F~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1195U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Results in Death	Influenza
0302831	01/16/2008	MA	36.0	36		F	01/15/2008	Heavy legs, restless legs, hypersensitivity which moved into her upper body days later (shoulders). No tx for this by her MD. Seen on 12/26/07. Dr. told pt it could have been a virus that got to her.									N	12/11/2007	12/12/2007	1	MRI - showing lesion at T2-T3; possible spinal tap next week if sx continue.	PUB	PUB	Tegretol 100 mg	No	Trigeminal Neuralgia			1						1	Hypersensitivity; Nuclear magnetic resonance imaging abnormal; Restless legs syndrome; Sensation of heaviness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA050AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0302836	01/16/2008	CO	16.0	16		F	01/16/2008	Pt developed Hives on body 20 minutes after receiving Influenza TIV and HPV immunizations.									N	01/14/2008	01/14/2008	0	N/A	UNK	UNK	Albuterol	none	Allergy to Sulfa			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2490AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0388U~2~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0302866	01/16/2008	MD	0.37	0	.4	F	01/15/2008	No adverse event given prior to the recommended 6 months age range									Y	12/26/2007	12/26/2007	0		PVT	PVT		No	No			1						1	Inappropriate schedule of drug administration; No adverse reaction	DTAP~SANOFI PASTEUR~C2800AA~2~UN~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2458AA~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF292AE~2~UN~LL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~A0301~2~UN~RL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~8707145A~2~UN~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0302869	01/16/2008	ND	5.0	5		F	01/09/2008	Skin rash/large red blotches on lower half of body.  Itching occurred 6-7 hours after vaccines given.  Parents administered Benadryl syrup by mouth.									Y	01/08/2008	01/08/2008	0	None	PVT	PVT		None	Branchio-otorenal syndrome, bilateral conductive hearing loss		ND0801	1						1	Erythema; Pruritus; Rash; Rash macular	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B067BA~5~IM~RL~DTAP (INFANRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500492P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~MERCK & CO. INC.~1326F~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1562U~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0302844	01/17/2008	NY	36.0	36		M	01/17/2008	Patient received FluMist vaccination on 5 Nov 07.  Patient was asymptomatic until 7-10 days later when developed malaise. Patient took 100mg acetaminophen q6h for 4 days then symptoms changed to fever, chills and productive cough treated with OTC items.  On 6 Dec 07 patient appeared for medical treatment after noticing hemorrhagic bullous lesion on his lips and oral mucosa on 5 Dec, and petechiae on legs on 4 Dec.  Labs showed platelet count of zero, which was confirmed.  Patient was diagnosed with suspected ITP with possible relation to vaccine and evacuated to medical center.  8/15/08 Reviewed medical reccords of 12/5/07-6/10/2008. FINAL DX: Idiopathic thrombocytopenia purpura assoc w/flumist vaccine. Records reveal patient experienced arthralgias, myalgias & fatigue approx 1 week s/p vaccination; HA, fever, chills & night sweats 10 days s/p vaccination; nasal congestion, post nasal drip, throat tickling, hacking cough w/SOB 2 weeks s/p vaccination; & dark spots on lower lip & legs, nosebleed, bleeding from lip lesion & productive bloody cough & extensive petechiae 1 month s/p vaccination.  Dx w/pneumonia intially but CBC revealed thrombocytopenia w/a platelet count of 0.  Admitted & tx w/steroids.  Transferred to higher level of care & tx w/platelet transfusion & IVIG.  Gradually improved & transferred to hospital on continued steroids.  Improved & d/c to home w/continued heme/onc f/u w/serial labs.				Y	Y	10			U	11/05/2007	12/04/2007	29	Zero platelets.  Rest of CBC, Chem Panel, LFTs were normal.  Mono spot was negative. No active bleeding.	MIL	MIL	Acetaminophen, ibuprofen, ascorbic acid, Nyquil, Guaifenesin DM	None	No previous medical history  PMH: HTN w/good control.  Family hx: type 2 DM.			1						1	Chills; Dermatitis bullous; Full blood count normal; Idiopathic thrombocytopenic purpura; Laboratory test normal; Liver function test normal; Malaise; Mononucleosis heterophile test negative; Productive cough; Pyrexia; Skin lesion; Activities of daily living impaired; Arthralgia; Blood chloride decreased; Blood glucose increased; Blood potassium decreased; Blood product transfusion; Chills; Coagulation test normal; Cough; Dyspnoea; Epistaxis; Fatigue; Full blood count abnormal; Haemoptysis; Headache; Increased upper airway secretion; Influenza like illness; Lip haemorrhage; Liver function test normal; Lymphocyte percentage decreased; Malaise; Monocyte count increased; Myalgia; Nasal congestion; Neutrophil count increased; Neutrophil percentage increased; Night sweats; Platelet count decreased; Platelet transfusion; Pneumonia; Pyrexia; Rhinorrhoea; Skin discolouration; Throat irritation; Thrombocytopenia; White blood cell count increased	FLUN3~MEDIMMUNE VACCINES, INC.~500491P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500491P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Hospitalisation	Influenza
0302894	01/17/2008	SD	48.0	48		F	01/17/2008	Swollen, red and itchy eyes~taking Benadryl.									N	01/16/2008	01/16/2008	0		UNK	UNK			Asthmatic with numerous allergies including eggs but had not had a problem in the past but have been battling with a slight allergic reaction for several weeks and I think this put it over the edge.			1						1	Eye pruritus; Eye swelling; Ocular hyperaemia	FLUX~UNKNOWN MANUFACTURER~~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0302922	01/17/2008	WI	0.67	0	.7	M	01/17/2008	After receiving the Flu vaccine, my son developed a fever about 5-7 hrs. later.  At 4 hours later his eyes and nose began running and he was cranky.  Throughout the night of 1/15-1/16 his fever continued to rise.  At 12:20pm on 1/16 he had a seizure due to rapid rise from fever.  His limbs turned blue, became rigid, had difficulty breathing.  Had CT scan, x-ray, blood, and urine test.  He is continued being treated with Motrin and Tylenol at a higher dosage.  He needs to go in for follow up chest x-rays-has developed an URI.				Y					U	01/15/2008	01/15/2008	0	CT Scan, X-ray (chest), Blood and Urine cultures.	UNK	UNK	None	None	None	seizure~Influenza (Seasonal) (no brand name)~1~0.60~Patient		1						1	Blood culture; Chest X-ray; Computerised tomogram; Convulsion; Culture urine; Cyanosis; Dyspnoea; Irritability; Lacrimation increased; Muscle rigidity; Pyrexia; Rhinorrhoea; Upper respiratory tract infection	FLUX~UNKNOWN MANUFACTURER~~1~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0302953	01/17/2008	FL	33.0	33		F	01/17/2008	I received a flu shot and The first 3 days I had some soreness. But then the following days I was completely unable to sleep. I had trembling in my body and anxiety. I was not able to sleep even when I took Benadryl. I did not sleep for a week. The dr. had to give me doxepin in order for me to sleep. The flu shot I found out had hydrocortisone. I think this was what produced my reaction.				Y					N	11/20/2007	11/24/2007	4		UNK	UNK	none	no	none			1						1	Anxiety; Insomnia; Pain; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0302966	01/17/2008	NJ	9.0	9		M	01/03/2008	Reddened area raised measuring 6.9 cm by 5 cm on upper left arm.				Y					Y	12/03/2007	01/02/2008	30		PVT	PUB						1						1	Erythema	FLUN3~MEDIMMUNE VACCINES, INC.~500489P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB182AA~UNK~SC~LA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1567U~UNK~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0302967	01/17/2008	NJ	9.0	9		M	01/03/2008	Reddened area raised measuring 8 cm by 5 cm on upper left arm				Y					Y	12/31/2007	01/02/2008	2		PVT	PUB		yearly visit				1						1	Erythema; Swelling	FLUN3~MEDIMMUNE VACCINES, INC.~500489P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB182AA~UNK~IM~LA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1567U~UNK~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0302970	01/17/2008	NC	4.0	4		M	01/15/2008	Pt. had a Bacillus abscess on his calf about 1 week after receiving vaccines.  Could there be any link to recalled vaccines.									Y	10/23/2007	10/30/2007	7	Aerobic bacterial culture-pos for Bacillus	PVT	PUB		Anemic on finger stick	None			1						1	Abscess bacterial; Bacillus infection; Bacterial culture positive	DTAP~GLAXOSMITHKLINE BIOLOGICALS~U2289AA~5~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2490AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~20873~4~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1324D~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1160U~2~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0302973	01/17/2008	PA	11.0	11		M	01/11/2008	R hand swelling 2 days after immunizations given, decreased speed of R finger movement.  Strength within normal & capillary refill normal.  Sent to ER to evaluate.  Afebrile.				Y					U	01/09/2008	01/11/2008	2		OTH	UNK		None				1						1	Mobility decreased; Oedema peripheral	FLU3~SANOFI PASTEUR~U2508AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB214AA~1~UN~RA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2236AA~1~UN~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B013AA~1~UN~LA~TDAP (BOOSTRIX)~1	USA	Emergency room visit	Influenza
0302974	01/17/2008	PA	1.0	1	.0	M	01/12/2008	Varicella vaccine given 1/9/08, broke out with varicella on 1/12/08.  102 degree fever on 1/12/08 and 2 blisters of varicella on abdomen on 1/12/08.									U	01/09/2008	01/11/2008	2	1. CBC & diff 1/12/08-normal.  2. varicella virus culture from blisters taken 1/12/08.	PVT	PVT	Tylenol	None				1						1	Blister; Full blood count normal; Pyrexia; Varicella; Virus culture	FLU3~SANOFI PASTEUR~U2505AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1501U~1~UN~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0302975	01/17/2008	TX	39.0	39		F		Immediate dizziness, weakness, nausea-recovered in 1/2 hour.  Head between knees and cold pack to neck were only treatment.									Y	01/11/2008	01/11/2008	0		OTH	PVT			penicillin	same~Vaccine not specified (no brand name)~UN~0.00~Sibling		1						1	Asthenia; Dizziness; Immediate post-injection reaction; Nausea	FLU3~SANOFI PASTEUR~U2493AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0302976	01/17/2008	TX	0.8	0	.8	F	01/11/2008	Child received flu vaccine #1 on 1/4/08.  On 1/7 pm developed fever, on 1/8 pm had generalized tonic-clonic seizure with fever up to 103.6 degrees.  Lasted about 15 l/q.  EMS called.  Seen at ER-nl exam & discharged without meds, Tylenol/Motrin.				Y					Y	01/04/2008	01/08/2008	4	Blood & urine culture negative	PVT	PVT	None	None	None (twin A had seizure but twin B no problem)			1						1	Blood culture negative; Culture urine negative; Grand mal convulsion; Pyrexia	FLU3~SANOFI PASTEUR~UT247AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB437BA~3~IM~LL~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0302979	01/17/2008	WA	29.0	29		F	01/16/2008	Suspect Bell's palsy.  Developed left sided facial numbness, weakness following flu vaccine.  Sent to ER but declined CT eval to r/o stroke (also had elevated BP at time).  02/06/2008 MR received for DOS 1/14/2008 with DX: Bell's Palsy.  Hypertension and Hx of same.  Pt presented to ER with c/o inability to close the L eye and drooling out of the L side of her mouth.  Pt developed severe headache 1 day following flu shot which progressed to neck pain the following day.  H/A and neck pain have subside but pt noticed facial weakness and was refered to ER for dx.  BP elevated on arrival to ER.   PE (+) for facial weakness, otherwise WNL.  Pt's BP txd and pt d/cd to F/u with PCP after declining CT scan.				Y					U	01/11/2008	01/13/2008	2	None	PVT	OTH	Albuterol, Flovent, fexofenadine, dimeprazole, ranitidine, hydroxyzine, furosemide, Benicar	HTN, GERD, anxiety	PCN, sulfa, cephalosporins, ACE-1, contrast dye. PMH:  HTN, asthma, reflux.			1						1	Blood pressure increased; Facial palsy; Facial paresis; Hypoaesthesia facial	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~U2525AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0302984	01/17/2008	CA	1.1	1	.1	M	01/16/2008	Patient was diagnosed with the chicken pox on 1/14/08.				Y					Y	01/02/2008	01/14/2008	12	None	PUB	OTH	None	None	None			1						1	Varicella	FLU3~SANOFI PASTEUR~UT2456EA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B70143R~4~IM~~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1175U~1~IM~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0187849	01/18/2008	PA	9.0	9		F	01/16/2008	Received immunizations during a well child visit, noted itchy eyes before leaving office, left office, walked a block, symptoms of itchy throat, chest tightness, facial swelling, returned immediately to office, brought into a room, given albuterol nob for expiratory wheeze, hives noted over body were worsening.  Given 0.2 ml of lmg/ml of epinephrine sub-Q and 2 mg/kg of Orapred.  EMS contacted, given IM Benadryl, observed at hospital for approximately 5.5 hours.  D/C to home, seen back in clinic next day and still well.  Time courses approximately 30 minutes after immunization, given Epi.  No history of egg allergy.				Y					Y	01/08/2008	01/08/2008	0	None	PVT	PUB	None	URI	Obesity, seasonal allergies, left axillary hidradenitis supporative			1						2	Chest discomfort; Eye pruritus; Swelling face; Throat irritation; Urticaria; Wheezing; Chest discomfort; Eye pruritus; Swelling face; Throat irritation; Urticaria; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500479P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB218AA~1~IM~LA~HEP A (HAVRIX)~2|VARCEL~MERCK & CO. INC.~1578U~2~SC~RA~VARICELLA (VARIVAX)~2|FLUN3~MEDIMMUNE VACCINES, INC.~500479P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB218AA~1~IM~LA~HEP A (HAVRIX)~3|VARCEL~MERCK & CO. INC.~1578U~2~SC~RA~VARICELLA (VARIVAX)~3	USA	Emergency room visit	Influenza
0303007	01/18/2008	AZ	5.0			U	01/18/2008	Child received 6 shots on 1/15/08.  Thursday, 1/17/08 child complained of pain in left arm, and areas that were numb. Mom also stated left upper arm was purple with a white center.  Mom took child to the ER 1/17/08.				Y					Y				Dr. diagnosed the child with cellulitis secondary to staph.  Child was put on Bactrim 15 cc PO BID for cellulitis X 10 days.	UNK	UNK						1						1	Cellulitis; Hypoaesthesia; Pain in extremity; Skin discolouration; Staphylococcal infection	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B051AA~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2497AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB215AA~1~IM~RA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~A01692~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0418U~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1765U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0303011	01/18/2008	OH	1.4	1	.4	F	01/17/2008	Information has been received from a health professional concerning a 13 month old 8.34 kg. 76.84 cm. female with torticollis, plagiocephaly, and an allergy to amoxicillin (rash), with a history of urinary tract infection (April 2007), diarrhea (05-AUG-2007), fever (06-AUG-2007), and febrile seizure (06-AUG-2007; WAES0712USA05193 who on 07-NOV-2007, was vaccinated with a dose of MMR II (lot#656529/0287U). Concomitant suspect vaccination given on the same day included 0.5 ml intramuscular dose in the right thigh Fluzone (lot# UT2456GA). On 14-NOV-2007 the patient developed a febrile seizure that lasted for 2 hours with a high temperature of 40 C. She was transported by ambulance to the hospital and was hospitalized for one week. In the ambulance she was given belladonna (+) chloroform (+) kaolin (+) morphine hydrochloride (+) pectin (+) phthalylsulfathiazole (+) streptomycin (DIASTAT). She was intubated and spent 5 days in the intensive care unit. While hospitalized she was given acetaminophen (TYLENOL), clindamycin, vancomycin, unspecified antibiotic and levetiracetam (KEPPRA). She was reported to be on dopamine and epinephrine at the time of the report. The mother reported that her daughter no longer regularly says please and thank you and will sometimes point at something rather than asking for it. The patient's vaccination history included that on 01-AUG-2007 she received a third 0.5 ml. dose of Haemohilus b conjugate (Meningococcal Protein Conjugate) and Hepatitis B (recombinant) vaccine, a first dose 0.5 mg of Varivax (Oka/Merck) (lot #656823/0305U), a fourth dose of 0.5 ml of DTaP (unspecified), and a fourth dose of 0.5 ml of Prevnar. Follow up information from a nurse in the primary care physician's office reported that on 23-NOV-2007, the patient was seen in the office for a follow up visit. Current patient status was not reported. It was also reported that the patient had previously been referred to a neurologist, but the reporter was not aware of the reason for the referral. Follow up information received from medical records indicated that on 14-NOV-2007, she spiked a temperature during the afternoon and then developed eye deviation, became unresponsive, tongue smacking, and then upper extremity tonic/clonic movements. She was brought to the emergency room via an ambulance where she was administered lorazepam (ATIVAN), midazolam (VERSED), fosphenytoin times two, and Phenobarbital to stop the seizures. At that point she was intubated secondary respiratory depression. Total time of the seizure was about 90-120 minutes. A Ct scan of the head showed no intracranial abnormality and maxillary sinus opacification. A chest x-ray was normal. She remained intubated and was admitted to the pediatric intensive care unit (PICU). She remained intubated overnight, and was extubated the following morning (15-NOV-2007). Shortly, after admission she developed hypotension requiring numerous fluid boluses to keep her mean arterial pressure (MAP) above 40. Therapy with dopamine and epinephrine was initiated and titrated as tolerated. The etiology of the hypotension was unclear, likely due to sedation from the Phenobarbital or midazolam (VERSED) versus infection. On 16-NOV-2007, she was weaned off the epinephrine drip. An echocardiogram revealed ASD with left to right shunting as well as enlargement of the RA and RV with normal biventricular function. Cardiology was consulted with a plan for cardiology follow up as an outpatient. On 19-NOV-2007, the dopamine was weaned off with MAP's consistently in the mid 50's. She was kept on maintence intravenous fluids (MIVF's), and 90ml/kg normal saline boluses to keep her MAP's in the 60's. Serial electrolytes were followed that were normal. On 17-NOV-2007, she was started on total parental nutrition (TPN) and advancement of her po food. By 19-NOV-2007, she was taking full po and her IVs were stopped. There was concern for infection as the cause of her seizures. Blood and urine cultures were obtained and resulted as normal. A lumbar puncture (LP) was performed that revealed spinal fluid results of on gram stain and a culture (negative). She was started on Clindamycin, Acyclovir, and Cefotaxime while cultures were pending (date not reported). The Acyclovir was discontinued when the HSV PCR was negative. On 16-NOV-2007, clindamycin was added for broader antibiotic coverage. She remained persistently febrile (values not reported). Repeat cultures were obtained that were also negative. With the hypotension and cultures negative for sepsis, she was treated with a seven day course of intravenous antibiotic to be followed with an additional seven days of oral Omnicef with maxillary sinusitis on CT scan. She exhibited decreasing WBC count and on 17-NOV-2007, it was 1700/mm3 with an absolute neutrophil count of 630/mm3 that by 19-NOV-2007, it had increased to 4200/mm3 WBC's with 4200/mme, absolut neutrophils (800/mm3), hemoglobin and hematocrit of 9.2g/dl/27.9%, and a platelet count of 191,000. The depression was thought to be secondary to viral suppression given her fevers or a medication effect from phenytoin (Dilantin) or Keppra. Neurology thought her seizure activity was a complex febrile seizure. She was kept on maintenance doses of phenytoin (Dilantin) and phenobarbital following loading dose of each medication in the emergency department. At the recommendation of neurology, a loading dose of levetiracetam (Keppra) of 40 mg/kg was administered followed by 20mg/kg every 12 hours maintenance. The phenytoin (Dilantin) was weaned off and she was maintained on levetiracetam (Keppra) non-therapy. On 20-NOV-2007, she underwent an MRI of the head that was normal. On 20-NOV-2007, she was moved out of the PICu, and transferred to general floor care. By 21-NOV-2007, she had been weaned off the physician (Dilantin), transitioned to oral levetiracetam (Keppra) in anticipation of it being stopped totally prior to her discharge. On approximately 20-NOV-2007, and viral exanthema was noted from her face to her pelvis. On 21-NOV-2007, she was discharged in good condition was discharged diagnosis of complex febrile seizure, and hypotension. She was discharged on levetiracetam (Keppra) 1 ml, every 12 hours orally for 5 days, cefdinir (Omnicef) 2.5ml twice a day orally, and diazepam 5 mg per rectum as needed. On 23-NOV-2007, she was seen in her primary care givers office for follow-up post intensive care unit admission for febrile seizures. The physician's assessment and plan was to have the patient evaluated by infectious disease to discuss if the seizure was fever related or due to a component in vaccinations. She had developed right lymphadenopathy likely due to immunizations versus recent illness and will be reassessed in 2 months. Her acute sinusitis was the only possible source of fever on evaluation and was completing a course of cefdinir (OMNICEF). The physician's diagnosis was acute sinusitis and inguinal lymphadenopathy. On 23-NOV-2007, she presented to the infectious disease clinic for evaluation for concern that her seizures may have been related to her having received immunizations. The physician's assessment and plan noted that her initial seizure that occurred in August 2007, she had received Varivax (Oka/Merck) one week prior to the development of the febrile seizure. The physician discussed with the patient's mother that this might have be true and that the patient could have a low threshold for seizure activity with fever. The physician indicated that it was hard to know if the fevers were due to live vaccines or an intercurrent viral illness. It was recommended that she undergo a repeat CBC with differential to be sure that the neutropenia had resolved, and a respiratory viral PCR nasal wash to rule out viral infection which may have been related to her neutropenia and questionable neutropenia while hospitalized. The patient had no reported seizure activity since her discharge and the levetiracetam (Keppra) had been discontinued. Per the recommendations of neurology (date not reported). The patient's mother reported that she was given a prescription for diazepam rectal gel (Diastat). The patient's vaccination history included: hepatitis B (manufacturer unspecified) on 30-JUN-2006; a first dose of haemophilus B conjugate (Meningococcal Protein Conjugate) and hepatitis B (recombinant) vaccine (MSD) on 31-AUG-2006, a second dose on 24-OCT-2006, and third dose on 01-AUG-2007: DTaP (manufacturer unspecified), a first dose 31-AUG-2006, second dose 24-OCT-2006, third dose 17-JAN-2007, and a fourth dose 01-AUG-2007; inactivated polio vaccine (manufacturer unspecified), a first dose on 31-AUG-2006, second dose on 24-OCT-2006, and a third dose on 17-JAN-2007; Prevnar, a first dose on 31-AUG-2006, a second dose on 24-OCT-2006, a third dose on 17-JAN-2007, and a fourth dose on 01-AUG-2007; and Varivax (Oka/Merck), a first dose on 01-AUG-2007. Additional information has been requested. All available medical records will be provided upon request.				Y	Y	0			Y	11/07/2007	11/14/2007	7	head computed axial 11/14/07 maxillary sinus opacification; no intracranial abnormality; echocardiography 11/14/07 ASD with left to right shunting, RA and RV enlargement; magnetic resonance 11/20/07 paranasal sinus mucosal thickening/opacification; body temp 11/14/07 40C; WBC count 11/17/07 1700 mm3; absolute neutrophil 11/17/07 630 mm3	PVT	PVT		Torticollis; Congenital skull malformation NOS; Penicillin allergy	febrile convulsion; immunisation; diarrhea; Urinary tract infection; Fever	febrile convulsion~Varicella (Varivax)~1~1.00~In Patient	WAES0712USA07978	1						1	Acute sinusitis; Atrial septal defect; Blood culture negative; Body temperature increased; Chest X-ray normal; Computerised tomogram abnormal; Culture urine negative; Dilatation ventricular; Echocardiogram abnormal; Expressive language disorder; Eye movement disorder; Febrile convulsion; Haematocrit decreased; Haemoglobin decreased; Herpes simplex serology negative; Hypotension; Intensive care; Intubation; Lumbar puncture normal; Lymphadenopathy; Neutropenia; Neutrophil count decreased; Nuclear magnetic resonance imaging abnormal; Personality change; Platelet count normal; Respiratory depression; Right atrial dilatation; Sinusitis; Tongue disorder; Tonic clonic movements; Unresponsive to stimuli; Viral rash; White blood cell count decreased	FLU3~SANOFI PASTEUR~UT2456GA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0287U~1~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Hospitalisation	Influenza
0303020	01/18/2008	TX	66.0	66		F	01/18/2008	Pt received shingles, flu and pneumonia vaccine. Reported to a Minor Emergency Clinic one week later due to breaking out with red painful patches to right side of body. Patient also was seen at Dermatology Clinic one day later. Physician stated rash was due to vaccine administered. The Minor ER started patient on Valtrex 1gm t.i.d. The Dermatology clinic con't the Valtrex and also Tylenol or Ibuprofen for pain. Pt stated mother had a severe case of shingles which caused mother to have a stoke and decease.				Y					U	12/21/2007	12/28/2007	7		UNK	UNK			allergy to Penicillin	red patches to R side~Zoster (Zostavax)~1~66.10~Patient		1						1	Rash	FLU3~SANOFI PASTEUR~U2511AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0555U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~0996U~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0303028	01/18/2008	WI	14.0	14		F	01/17/2008	10/18/07 and 12/30/07 RE: 10/18/07 pt-Had 2nd Gardasil vaccine & Flu shot at about 5:15 PM. When I called to schedule her 2nd Gardasil shot, I asked if she could also receive her Flu shot at the same time. I was told sure, no problem. On 10/18-when they were getting things ready-they mentioned that when pt returns for her 3rd Gardasil vaccine, she should also received her 2nd chicken pox vaccine. When the nurse took the vaccine out of the refridgerator, she dropped it. She then said Oh, that's not good. I don't know which of the two vaccine she dropped. My daughter was sitting in the chair, she received one shot in each arm. (I don't recall which one first, or which one in which arm). She remained seated for a minute or two, then she got up & I sat down to get my flu shot. Just as my shot was complete, I was putting my shirt sleeve back in order, I heard a bang. It was daughter-she had fallen back, hit the wall, and had gone down to the floor. Her eyes were rolling back & she went out. The nurses & I got her flat & then raised her feet up onto a chair. She was out for a short time...when she came to we removed her jacket. Her head, neck, and back hurt. They called for a Dr. to come check her out. They looked into her ears, and eyes. They told me to keep an eye on her, and that she maybe sore from hitting the wall & going down. She had never had anything like this happen to her before, so she was quite shaken up. Then on Sunday 12/30/07-she had been snowmobiling with her Dad through out the day, up at his cabin (which is three hours away from home). They had slept in, went out for breakfast. Rode during the day, and had stopped for pizza around 5 PM. The pizza was just about to come out of the oven, and while she was standing up, she suddenly told her dad that she felt dizzy. As quick as he stood up, she had gone down (Again). They got her up & put her in a chair...they got her some water to drink. There happened to be a nurse there, and she said no, give her Orange Juice, that'd be better. The nurse suggested that she go to the ER. So, they borrowed someone's car and went to Hospital ER. They drew blood tested urine and checked her out. They could not find any apparent reason for the fainting. I did request and receive the records from them.				Y					U	10/18/2007	10/18/2007	0	10/18-No labs 12/30/07-# of labs-all ok	PVT	OTH	None	None	None			1						1	Back pain; Dizziness; Fall; Gaze palsy; Headache; Laboratory test normal; Loss of consciousness; Neck pain; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79241~3~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HPV4~MERCK & CO. INC.~1265U~2~IM~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0303032	01/18/2008	PA	8.0	8		M	01/14/2008	Developed Varicella like rash.										12/14/2007	01/08/2008	25		PVT	UNK	None	None	None			1						1	Rash vesicular	FLUN3~MEDIMMUNE VACCINES, INC.~500490P~1~~~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~1355U~2~~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0303038	01/18/2008	GA	36.0	36		F	01/18/2008	Local reaction immediately after getting flu vac. Reddness, swelling, itching. 5 days later started breaking out in hives all over body and throat closing up				Y					N	10/26/2007	10/26/2007	0		PVT	PVT		None	None			1						1	Erythema; Local reaction; Pruritus; Swelling; Throat tightness; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA043AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0303044	01/18/2008	IA	52.0			M	01/18/2008	Arm got progressively more sore after injection.  Sought medical care and needed PT to work on Range of Motion and Darvocet for pain.				Y					Y				n/a	PVT	PVT	n/a	n/a	n/a			1						1	Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~u2457ca~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0303049	01/18/2008	CA	58.0	58		M	01/18/2008	Within a week of the shot I began to develop a rash on the thighs that became intensely itchy and has spread to the whole body by about 5 weeks later.  This may be the third year in a row that this has happened to me, and this year I noticed the temporal relationship and realized that this might be a reaction to the flu shot I received in early December 2007.									U	12/13/2007	12/16/2007	3	none done to date	UNK	UNK		none	none			1						1	Rash generalised; Rash pruritic; Similar reaction on previous exposure to drug; Vaccine positive rechallenge	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0303083	01/18/2008	OR	46.0	46		F	01/19/2008	Fatigue, internal burning, ache, muscle ache.				Y					U	12/13/2007	01/17/2008	35		OTH	OTH	None	None	None			1						1	Burning sensation; Fatigue; Myalgia; Pain	FLU3~SANOFI PASTEUR~112515AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0302004	01/19/2008	MI	14.0	14		F	01/19/2008	None									U	10/24/2007				UNK	UNK		none	none			1						2	Inappropriate schedule of drug administration; Medication error; Inappropriate schedule of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~6886579~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~6886579~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA		Influenza
0303056	01/20/2008	NY	1.0	1	.0	F	01/20/2008	FEVER FOR 4 DAYS, 5 DAYS POST VACCINATION ASSOCIATED WITH REDNESS SLIGHT INDURATION ON SITE OF INJECTION, LEFT THIGH. FOLLOWED BY MACULOPAPULAR ERUPTION ON FACE TRUNK WHEN FEVER ABATED.									Y	01/09/2008	01/14/2008	5		UNK	UNK		NONE	N/A			1						1	Injection site erythema; Injection site induration; Pyrexia; Rash maculo-papular	FLU3~SANOFI PASTEUR~UT2477FA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0748U~1~IM~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1363U~1~IM~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0303058	01/21/2008	GA	72.0	72		M	01/21/2008	Patient came to clinic with complaints of swelling and discomfort to right arm. Minimal amount of swelling noted to right upper arm, nontender and no erythema. Advised patient to see PCP if redness or pain.[Additional Comments by: APRN (10/21/2007 1:55:23 PM)] 10/21/2007 patient came to clinic with complaints of redness, pain, tenderness and swelling to right upper arm. On examination, right upper arm erythematous, tender to touch, swollen, and warm to touch. Patient with history of diabetes. We referred him to Urgent Care for treatment. Stressed importance of being seen today for treatment, and following up with pcp.				Y					U	10/19/2007	10/20/2007	1	unknown	UNK	UNK	Unknown	No	Unknown			1						1	Erythema; Oedema peripheral; Skin warm; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA298BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0961U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0303069	01/21/2008	PA	56.0	56		M	01/21/2008	We received from a consumer via the Medical Communication the following information on 09 JAN 2008: A 56-year-old man, born on 29 JUN 1951, was vaccinated with Fluvirin, batch-no 79897, i.m. on 19 NOV 2007. Ten days after the vaccination he lost 100% hearing out of the left ear and 40% out of the right ear. He has been diagnosed with vestibular neuritis. The patient has not yet recovered at the time of report (09 JAN 2008). We received additional information on 14 JAN 2008: The patient was vaccinated on 18 NOV 2007 at 01:30 p.m. Approximately 8-9 days later he developed vertigo which on 30 NOV 2007 developed in a full blown vertigo. Approximately 12 days after receiving the vaccine (30 NOV 2007) loss of hearing was reported which worsened over time. This was initially evaluated by a physician on 03 DEC 2007 and initially treated with an antibiotic. He went to ER on 04 DEC 2007 and was treated with Antivert, 25 mg three times a day and discharged. On 11 DEC 2007, CT scan was completed and negative. MRI was completed on 12 DEC 2007 and was also negative. The patient has had additional physician visits and was diagnosed as having vestibular neuronitis and viral labyrinthitis. The patient has not yet recovered at the time of report. 17 JAN 2008: Conclusion based on batch review - The batch review cannot conclude the reason for the reported adverse reactions.									N	11/18/2007	11/30/2007	12		OTH	OTH	No other medications	Unknown			MA20080029	1						1	Computerised tomogram normal; Deafness bilateral; Nuclear magnetic resonance imaging normal; Vertigo; Vestibular neuronitis; Viral infection; Viral labyrinthitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79897~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0303098	01/22/2008	MS	2.0	2	.8	F	01/22/2008	Vasovagal syncopal reaction - loss of consciousness with amnesia.  No seizure activity, no post ictal period.				Y					Y	12/21/2007	12/21/2007	0		MIL	MIL	None	None	None			1						1	Amnesia; Loss of consciousness; Syncope vasovagal	FLU3~SANOFI PASTEUR~U2506AA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0515U~1~UN~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0303161	01/22/2008	OH	60.0	60		F	01/22/2008	Patient received a Flu vaccination in the R arm -states the immunization was given very high near the shoulder bone - immediately she began to experience excruciating pain - didn't report to nurse because she thought it would go away in a few days - She is unable to lift her arm over her head -she went and saw her Dr. because she has a history of MS - the Dr repoted that it was not an exacerbation of the MS but it may be nerve damage and would take 6-8 wks to heal - She called today because it has been over 30 days and there has been no improvement - Her Drs are sending her to the emergency room today because the pain is so excruciating her blood pressure is running 200s/100s and is uncontrollable - She states the Dr. has maxed her out on BP medication - She currently takes Vicodin 1 every 6-8 hrs. but it is prescribed for every 4 hrs -She states she doesn't want to become addicted - Patient was encourage to follow through with the Emergency Room instructions per her Dr. and to take the Vicodin as prescribed.				Y					U	12/19/2007	12/19/2007	0		UNK	UNK		No Acute Illness	MS, HTN, Heart Disease			1						1	Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2465AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0303164	01/22/2008	NE		0	.0	F	01/22/2008	FLUARIX 2007-08 0.5ML ADULT DOSE INADVERTENTLY ADMINISTERED TO NEWBORN BABY.  HEPATITIS B VACCINE IS WHAT NURSE WAS TRYING TO ADMINISTER.									Y	01/21/2008	01/21/2008	0	NONE	UNK	UNK	VITAMIN K 1MG IM X 1 DOSE.  ERYTHROMYCIN EYE OINTMENT OPHTHALMIC X 1 DOSE.	NONE	NONE			1						1	Inappropriate schedule of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA294DA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0303198	01/22/2008	NJ	1.0	1	.0	F	01/22/2008	Cellulitus at site left upper arm; Prevnar flu given 1/4/08; Admitted 1-15-08 -> 1-18-08 1/23/08-records received for DOS 1/15/08-ED report presented with C/O fever since night before. Temp 103.8. Left upper arm with tender induration 2cm in diameter on lateral aspect, no fluctutation. Right upper arm lateral aspect with needle mark and mild swelling, no redness no tenderness. Impression Arm abscess.   3/27/08-DC Summary received for DOS 1/15-1/18/08 DC DX: left arm cellulitis. leukocytosis. Fever.				Y	Y	3			Y	01/14/2008	01/15/2008	1	1/23/08-records received-WBC 24.5, segmented neutrophil increased 52, lymphocytes decreased 35, eosinophils increased 6, absolute neutrophils increased 13.2, absolute eosinophils increased 1.5, absolute monocytes increased 1.2.	UNK	UNK	None	None	None			1						1	Injection site cellulitis	FLU3~SANOFI PASTEUR~UT2477BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0425U~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~870145C~4~IM~LA~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1470U~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0303221	01/22/2008		28.0	28		F	01/23/2008	We received on 16 JAN 2008 via agency from a consumer the following information: A 28-year-old female patient, born on 22 JAN 1979, was vaccinated IM with 0.5 ml Fluvirin, batch no. unknown, on 14 NOV 2007.  At 12-13 weeks gestational age caller discovered via ultrasound that she had miscarried on 08 JAN 2008.  Company assessment: seriousness criterion: medically significant.  Causality: insufficient date (the amount of data is insufficient to finally assess causality as information about the pregnancy is missing).  Expectedness assessment according to product information: Miscarriage is unexpected, drug exposure during pregnancy is expected after vaccination with Fluvirin.  On a case level, the case is considered unexpected.  No change in benefit-risk-ratio.  No measures necessary.  No.: NA08-00183.									Y	11/14/2007	01/08/2008	55		OTH	OTH	No other medications	Unknown			MA20080051	1						1	Abortion spontaneous; Drug exposure during pregnancy	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0303222	01/22/2008		31.0	31		F	01/23/2008	We received on 16 JAN 2008 via local agency, from a consumer the following information: Consumer left voice mail stating that she received vaccine in November. She wants to report an adverse event that she had her colleague (see case no. MA2008-0051) experienced. No additional information left with message. Addendum: On 16 JAN 2008 we received the following information: A 31-year-old female patient, born on 02 APR 1976 was vaccinated i.m. with 0.5 ml Fluvirin, batch no. unknown, on 14 NOV 2007. At 9 weeks gestational age caller discovered that she had miscarried on 29 NOV 2007. Company assessment: Seriousness criterion: medically significant. Causality: insufficient data (the amount of data is insufficient to finally assess causality as information about the pregnancy is missing). Expectedness assessment according to agency and local product information: Miscarriage is unexpected drug exposure during pregnancy is expected after vaccination with Fluvirin. On a case level, the case is considered unexpected. No change in benefit-risk-ratio. No measures necessary. Local agency no.: NA08-00160									Y	11/14/2007	11/29/2007	15		OTH	OTH	No other medications	Unknown			MA20080052	1						1	Abortion spontaneous; Drug exposure during pregnancy	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0303228	01/22/2008	WA	5.0	5		M	01/17/2008	Raised Reddened Skin. area measurers 7x6 cm right deltoid Little pain, warm to Touch, very Itchy, Had Dtap, Flu, Varicella in that arm.									Y	01/15/2008	01/17/2008	2	949.9	PVT	PUB	Tylenol 160mg. Hydrocortisone 2.5%; Loratadine 5mg	NONE	NONE			1						1	Erythema; Pain in extremity; Pruritus; Skin warm; Swelling	DTAP~SANOFI PASTEUR~C2800AA~6~UN~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~81460G~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1518U~3~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0303237	01/22/2008	TX	1.54	1	.5	F	12/31/2007	Given immunizations on 12/17/07, parent states child's lips, eye, ears, and throat began to swell approximately 4 hrs after immun. She sates red rash on body and face. Take to ER, was given a steroid shot and Benadryl. Stayed for 4 hrs before being released once swelling and rash started to subside.				Y					Y	12/17/2007	12/17/2007	0		PUB	PUB		None	None			1						1	Auricular swelling; Erythema; Eye swelling; Lip swelling; Pharyngeal oedema; Rash generalised	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B110AB~2~UN~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2456EA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB213AA~1~UN~LL~HEP A (HAVRIX)~1|HIBV~SANOFI PASTEUR~UF208AA~2~UN~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~1028F~1~UN~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B47300K~2~UN~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1107U~1~UN~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0303239	01/22/2008	NC	9.0	9		M	01/18/2008	Erythema at sight of injection 2-2 1/2 inches. Slight induration and tender, no fluctuations, 3 days after Varivax. Afebrile				Y					Y	01/15/2008	01/16/2008	1	none	PVT	PVT	Benadryl, multivitamins	none	none			1						1	Injection site erythema; Injection site induration	FLUN3~MEDIMMUNE VACCINES, INC.~500500P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB213AA~1~IM~LL~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1360U~2~IM~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0303241	01/22/2008	PA	12.0	12		F	01/18/2008	(R) arm, edema, red, warm, peeling - 2 from site of injection down to elbow. Could not straighten arm out. T 99, was itchy. Was put on antibiotic, was to call/come back PRN.									U	01/15/2008	01/18/2008	3	None	PVT	PUB	None	None	Noonan's Syndrome			1						1	Body temperature increased; Erythema; Injected limb mobility decreased; Oedema; Pruritus; Skin exfoliation; Skin warm	FLU3~SANOFI PASTEUR~U2502AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~4495U~1~IM~LA~HEP A (VAQTA)~1|PPV~MERCK & CO. INC.~0601F~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2609AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0303243	01/22/2008	MI	59.0	59		F	11/16/2007	Local 4x6 cm pink mildly pruritic rash at injection site left deltoid within 15 minutes.  Resolved completely within several hours.									Y	11/16/2007	11/16/2007	0		UNK	UNK						1						1	Injection site discolouration; Injection site pruritus; Injection site rash	FLU3~SANOFI PASTEUR~U2462AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0303250	01/22/2008	IN	39.0	39		F	11/16/2007	C/O itching (L) anterior arm below elbow. Approximately 1hr 15 minutes after receiving injection. No rash, swelling or discoloration noted. Redness not as signs of scratching at site. Ice pk applied with relief noted. Injection site no visible signs. Only slight redness where band aid was.									Y	11/14/2007	11/14/2007	0		PUB	PVT	None	None	None			1						1	Erythema; Pruritus	FLU3~SANOFI PASTEUR~U2497AA~7+~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0303255	01/22/2008	OH	4.0	4		F	12/20/2007	Pt lying in mom's arms after vaccines given and fainted after 3rd vaccine. Patient recovered after ammonia ampoule held under nose. Pulse was 88. Color did not change. Recovered fully after 5 minutes.									Y	12/20/2007	12/20/2007	0	None	PUB	UNK	None	None	None			1						1	Syncope	FLU3~SANOFI PASTEUR~UT2460EA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB409AA~3~IM~RA~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB213AA~2~IM~RA~HEP A (HAVRIX)~1	USA		Influenza
0303257	01/22/2008	NJ	1.0	1	.0	M	01/21/2008	Cranky x2 days.  Red area of induration L upper outer thigh.									U	01/10/2008	01/19/2008	9		PVT	UNK		GER, R OME	GER			1						1	Injection site erythema; Injection site induration; Irritability	FLU3~SANOFI PASTEUR~U2526AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1259U~1~IM~RL~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~1121U~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0302481	01/23/2008	TX	16.0	16		M	01/18/2008	Seriousness criteria: other-medically significant.  Initial report received on 11 January 2008 from a health care professional.  A 16-year-old male patient, with no illness at the time of vaccination, had received a left arm injection of Menactra, lot number U2420AA; a left arm injection of Fluzone SV 2007-2008, lot number U2508AA; and a right arm injection of hepatitis A vaccine, manufacturer GSK, lot number AHAVB17AA; on 17 December 2007.  Two days post-vaccination, the patient began to experience trouble breathing at night with stridor lasting for a few seconds.  The patient did not have a past medical history of asthma.  He experienced these episodes two to three times per week.  Lateral X-ray of the neck was normal.  The patient was examined by an ENT specialist (findings not provided) and was scheduled to see an allergist.  Treatment provided was not reported.  The patient had received a prior dose of Menomune, but the year of administration was not provided.  Recovery status was not reported.				Y					U	12/17/2007	12/19/2007	2		PVT	PUB		The patient had no illness at the time of vaccination.	The patient had no past medical history at the time of vaccination.		200800103	1						2	Dyspnoea; Stridor; X-ray normal; Dyspnoea; Stridor; X-ray normal	FLU3~SANOFI PASTEUR~U2508AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB17AA~UNK~UN~RA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2420AA~UNK~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|FLU3~SANOFI PASTEUR~U2508AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB17AA~UNK~UN~RA~HEP A (HAVRIX)~2|MNQ~SANOFI PASTEUR~U2420AA~UNK~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2	USA	Emergency room visit	Influenza
0303287	01/23/2008	NY	1.56	1	.6	M	01/23/2008	Painful left thigh swelling to approximately twice normal diameter. No impairment of walking and no signs of infection, improving at time of office visit 1/23/08 at 9:30am.				Y					Y	01/21/2008	01/21/2008	0		UNK	UNK	none	none	none			1						1	Injection site pain; Injection site swelling	DTAP~SANOFI PASTEUR~U1857CA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT2459PA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB206CA~2~IM~RL~HEP A (HAVRIX)~1|HIBV~SANOFI PASTEUR~UF229AA~4~IM~RL~HIB (ACTHIB)~1	USA	Emergency room visit	Influenza
0303310	01/23/2008	MN	49.0	49		F	01/23/2008	Patient given an expired dose of Flumist. Dose expired on 1-10-08. Given on 01-23-08.									Y	01/23/2008	01/23/2008	0	N/A	UNK	UNK		N/A	Hypothyroidism			1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500479P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0303314	01/23/2008	CA	41.0	41		U	01/23/2008	Patient recieved influenza vaccination on 12-21-2007 Sanofi U2509AA 06-30-2008 in the R deltoid. Good site location was noted when complaint was stated.  Pt. c/o of local site pain/discomfort on 01-22-2008.  Client stated that after 2-3 weeks of injection pt. presented to same clinic and saw LVN and stated she still had site pain and discomfort with movement that radiated to the tricep area on the right arm.  LVN told her to stop taking ASA and start taking acetaminophen for the discomfort/pain.  No report was filed to lead nurse at the time.  On 01-22-2008 pt presented to R.N. and restated symptoms with c/o of lightening pain when she lifts her right arm over the height of her shoulder.  Client has no insurance and wants pmd evaluation.  I directed her to my supervisor with instructions to file her complaints/expectations in writing with a copy of a picture her husband took 2 weeks after the injection, ASAP.  I also gave her my supervisor name/address/phone, my name, nurses names.  I asked if she had tried any NSAIDs for the discomfort and asked if she has any allergies/stomach ulcers/liver or kidney disease.  She stated no, I recommended ibuprofen 200mg tabs ii po q8hrs x 3 days with meals and outlined possible stomach problems that may occur and to stop if they occur. I also stated that if no relieve or lessing of discomfort was noted after 3 days to stop the NSAIDs. pt. stated understanding and left with that information. The next day I called the immunization coordinator for the county and left a message for her to contact me regarding this patient then I completed the VAERS form via email while I awaited her response.									N	12/21/2007	12/21/2007	0	None done. No insurance and no pmd.	UNK	UNK	None specified by pt.	None specified by pt.	None specified by pt.			1						1	Injected limb mobility decreased; Injection site pain	FLU3~SANOFI PASTEUR~U2509AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0303328	01/23/2008	NY	0.81	0	.8	F	01/16/2008	Experienced extreme respiratory arrest and was prescribed Prednisolone. Per 60 day follow up: 1st vaccine was Nov. 5, 2007 this was when the adverse reaction began. Flu vaccine 1st on 05/11/2007. She has had severe episodes of asthma and many hospitalizations for her respiratory problems ever since she had the flu shot. It compromised her immune system, which responds in a hyperactive way now anytime she gets a minor cold or reacts to something in the environment. She was perfectly healthy prior to this flu shot. 1/20/2010 Patient was born 6 weeks premature. We were rushed back into the hospital 4 days after she was born, because she was severely jaundiced and underweight (her weight had dropped below 5 pounds). She did a week of phototherapy and left the hospital fine. She caught up quickly and is now in the 90th percentile for height. She caught her first cold at 8 months (right after her first flu shot), and that set off her first asthma attack. From October 2007 to April 2008, she was hospitalized 3 times for asthma and had 5 asthma episodes. During each episode, she took Xopenex every 4 hours as needed, Pulmicort twice a day, and an oral steriod for 4 days. We would usually continue the Pulmicort twice a day for 2 weeks to make sure she would not relapse. After seeing several specialists, we understand now that colds and flues trigger Seienna's asthma. She does have some food allergies to garlic and she is sensitive to raw citrus and eggs. These foods will cause her to break out in hives and eczema; we have creams to treat this. Based on the recommendations of her doctors, we changed her diet, and since then she has done much better. And believe it or not, she still has a balanced diet and finds a lot to eat! We just started her on a multi-vitamin and she is taking some supplements to boost her immune system. She does not take any medications regularly for he asthma, but we ar prepared with a nebulizer at home and traveling nebulizers in her personal things. Plus, we have ample supplies of Pulmicort and Xopenex in case she has another attack. Within the past six times due to her severe asthma episodes. The most recent episode was so severe the doctors placed her in an oxygen tent! We have made a lot of proactive changes in our home to make it more healthy and less toxic for her, like switching all of our household products to all green.					Y	2			N	12/21/2007	01/12/2008	22		PVT	OTH		None	born premature-had similar reaction to flu shot on 11/5/07	~Influenza (Seasonal) (no brand name)~2~1.00~Patient		1						1	Asthma; Food allergy; Jaundice; Respiratory arrest; Underweight	FLUX~UNKNOWN MANUFACTURER~UT24077AA~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0303330	01/23/2008	FL	1.6	1	.6	F	01/21/2008	Bell's palsy 2 1/2 wks after immunizations persisting. Sx's started 1/10/08 approx.  1/25/08 Reviewed pcp medical records which reveal patient seen 1/21/08.  Had cold s/s w/fever 1-2 wks prior.  Developed right eye ptosis, right facial droop, neg facial/labial fold x approx 10 days prior to office visit.  Referred to ENT who saw patient 1/21/08 who dx w/left Bell's palsy & tx w/antiviral med.  DX: Bell's palsy. 1/25/08 Received vax record w/flu info.  Fluzone, SP, UT2460AA6, left thigh.				Y					U	12/18/2007	01/10/2008	23	sent to ENT LABS: rapid strep (-).	PVT	UNK	None	None	None			1						1	Facial palsy	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B1256B~1~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2460AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0184U~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B54016A~3~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1559U~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0303345	01/23/2008	CA	1.1	1	.1	M	01/23/2008	Approx a day after vaccination (or <24 hrs) pt. falls forward or occasionally feel down after walking (ataxia), unusual as per mom.  Started walking 4-5 wks ago.    2/19/08 Reviewed hospital medical records which reveal patient experienced difficulty walking x 1 day, falling backwards whenever standing up.  Also emesis x 2.  Admitted 1/10-1/11/08. FINAL DX: Ataxia, post viral vs post vaccination.				Y	Y	2			Y	01/08/2008	01/09/2008	1	CT, no acute abnormality; MRI, within normal limit; CBC, BMP, LFT's, CRP, CK 228  LABS: CT of head WNL.  CBC & chemistry WNL. CK 228 (H). Plts 449 (H).  Blood c/s neg.	PVT	PUB	None	Mild cold	Atopic dermatitis or eczema  PMH: URI 1 wk prior to admit.  Eczema.  Sibling w/URI at present.			1						1	Ataxia; C-reactive protein; Computerised tomogram normal; Fall; Liver function test; Nuclear magnetic resonance imaging normal	FLU3~SANOFI PASTEUR~UT2475BAA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB171AA~1~IM~UN~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~09867~1~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1246U~1~SC~UN~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0303347	01/23/2008	WA	0.6	0	.6	F	01/03/2008	None Stated										12/13/2007				PVT	PUB	None	None	None			1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U2435AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF216AA~2~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~AC52B016BA~1~IM~LL~PNEUMO (PREVNAR)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B016BA~1~IM~LL~TDAP (BOOSTRIX)~1	USA		Influenza
0303348	01/23/2008	AZ	1.8	1	.8	M	01/23/2008	Urticaria within 10 min of shot										01/23/2008	01/23/2008	0		PVT	PVT		chronic rhinitis; allergic rhinitis, bronchitis				1						1	Urticaria	DTAP~SANOFI PASTEUR~U2289BA~4~UN~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2525AA~4~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB218BA~2~UN~LA~HEP A (HAVRIX)~1	USA		Influenza
0303349	01/23/2008	TN	4.0	4		M	01/16/2008	local Reaction left arm, 50 cent size swelling on right deltoid, no drainage, some overlying				Y					Y	01/10/2008	01/10/2008	0	Rapid Strep neg. 1-10-08/ Rapid Strep pos on 12-31-07	PVT	PUB	Xopenex, Singulair	Sinus Cong./dr. in throat				1						1	Local reaction; Oedema peripheral; Streptococcal identification test	DTAP~SANOFI PASTEUR~U23543A~3~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2489AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~205472~4~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0288U~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1251U~2~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0303355	01/23/2008	TX	0.4	0	.4	M	01/22/2008	eye discharge, bump, knott 2cm x 2.5cm on Lt. Thigh									Y	11/19/2007			None	PVT	PVT	None	None	None			1						1	Eye discharge; Mass	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B125CB~2~UN~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2514AA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF217AA~2~UN~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B08000F~2~UN~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0973U~2~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0303363	01/23/2008	HI	0.6	0	.6	M	01/15/2008	At 20:30 on 1/14/08 child had a one minute episode of generalized body tremor, which self-resolved.  The child was febrile at the time.				Y					Y	01/14/2008	01/14/2008	0	None	PVT	PVT	None	None	None except G6PD deficiency			1						1	Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U2443AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0303364	01/23/2008	CA	1.0	1	.0	M	01/18/2008	5 cm x 5 cm redness and swelling lt thigh									U	01/15/2008	01/16/2008	1		OTH	PUB	Tylenol; Flouride	none	none			1						1	Erythema; Swelling	FLU3~SANOFI PASTEUR~U2435AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB171AA~1~UN~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0282U~1~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B54013H~UNK~UN~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1509U~1~UN~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0303367	01/23/2008	CA	3.0	3		F	01/15/2008	Erythematous, raised body-hive rash.									Y	01/14/2008	01/14/2008	0	None	PVT	PVT						1						1	Rash erythematous; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500496P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0303368	01/23/2008	FL	67.0	67		F	01/23/2008	Pain, soreness, erythema, swelling, induration.				Y					Y	01/15/2008	01/16/2008	1	None	PVT	PVT		None	NKDA			1						1	Erythema; Induration; Myalgia; Pain; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA066AA~2~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1541U~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0303370	01/23/2008	GA	65.0	65		M	01/18/2008	Pt. received Flu in L deltoid & PNU 23 in R deltoid 12-27-07 at 3:30pm.  By 9pm pt. c/o swelling R deltoid (size of 1/2 grapefruit).  Pt. had chills & fatigue (severe enough to stay in bed for 3 days).									Y	12/27/2007	12/27/2007	0	None	PUB	PUB		None	None	mild hives~Influenza (Seasonal) (no brand name)~UN~0.00~In Patient		1						1	Activities of daily living impaired; Chills; Fatigue; Injection site swelling	FLU3~SANOFI PASTEUR~U2505AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0880F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0303375	01/23/2008	NH	8.0	8		M	01/16/2008	Patient was given Varivax and Flu vaccine 1/15/08 about 9am. 1/16/08 mom called at noon stating arm red, hot to touch, swollen and bothering patient; 10cm Indurated area Noted				Y					Y	01/15/2008	01/16/2008	1	Treated with Keflex 250/5 three times a day 7 days	PVT	PUB	Albuterol PRN via Nebulizer		RAD			1						1	Erythema; Induration; Skin warm; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80822~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARCEL~MERCK & CO. INC.~1496U~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0303376	01/23/2008	TX	14.0	14		M	01/09/2008	fever 102 deg F after 8 hrs of vaccine HA prior to onset of fever vomited x 1. Pt was in Er in the clinic 24 hr later asymptomatic body aches.				Y					Y	11/14/2007	11/15/2007	1	HA acute onset Per ER records Fever, Vomiting adverse rxn to Flu shot per ER records	PVT	PVT		None				1						1	Headache; Immunisation reaction; Pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2489AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0303379	01/23/2008	NC	1.6	1	.6	M	01/17/2008	10x6 cm area of redness, mild induration.									Y	01/14/2008	01/15/2008	1		PVT	PUB						1						1	Erythema; Induration	DTAP~SANOFI PASTEUR~U2289CA~4~UN~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2508AA~2~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~B217BA~2~UN~LA~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~B97283A~4~UN~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0303385	01/23/2008	MN	51.0	51		F	01/16/2008	Diaphoretic, weak one hr after injection. BP 146/90, P 114, O2 Sat 100% RA, T 97.9 - MD called, had her lie down on (R) side, monitored VS and called 911 - sent to ED.				Y					Y	01/08/2008	01/08/2008	0		OTH	OTH	Propylthiouracil 50 mg TID; Lopressor 100mg BID; Celexa 0.5 mg	None	NKA			1						1	Asthenia; Blood pressure; Heart rate increased; Hyperhidrosis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA052AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB4388A~1~IM~LA~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0303386	01/23/2008	MI				F	10/17/2007	Patient came back with rash on hands after 1/2 hr. and complain about having nausea after 1 & 1/2 hr. (90 minutes).									Y	10/17/2007	10/17/2007	0		OTH	OTH		None	None			1						1	Nausea; Rash	FLU3~SANOFI PASTEUR~U2524AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0303387	01/23/2008	MN	1.0	1	.0	M	01/08/2008	Local hives at the site of subcutaneous injection of VZV developed within minutes of immunization									Y	01/07/2008	01/07/2008	0	Negative RAST tests to gelatin and egg	PVT	PVT	Albuterol, Zantac	Vomiting	Cow milk allergy			1						1	Injection site urticaria; Radioallergosorbent test negative	FLU3~SANOFI PASTEUR~UT2459NA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0527U~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08702K~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1248U~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0301610	01/24/2008	VA	55.0	55		F	01/03/2008	Within 1 to 2 days client had edema of her fingers on both hands with stiffness. Especially noticed the stiffness at night and when she needs to remove her rings. When she saw her doctor for a physical she mentioned this to the doctor. The doctor ran blood work and it all returned normal.									N	10/15/2007	10/17/2007	2		OTH	OTH	NA	None	None			1						2	Blood test normal; Musculoskeletal stiffness; Oedema peripheral; Musculoskeletal stiffness; Oedema peripheral	FLU3~SANOFI PASTEUR~U2516AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2516AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0303458	01/24/2008	NC	50.0	50		F	01/24/2008	Shortness of breath, sore throat, fatigue muscle aches headaches congestion after doxycyline and amoxicillin still congested and fever. The date of the vaccine was Oct. 25 2007 Temperature 104.F.				Y					N	10/25/2007	10/26/2007	1	Still sick patient seen Medical Clinic on 6 occasions since immunizations. And ER visit on 1/16/08.	UNK	UNK		Hypertension		~Influenza (Seasonal) (Fluvirin)~~50.00~Patient		1						1	Dyspnoea; Fatigue; Headache; Myalgia; Nasal congestion; Pharyngolaryngeal pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0303494	01/24/2008	OH	3.0	3		M	01/05/2008	Received flu vaccine on Thursday and had reaction. By later same day and into Fri am very firm, swollen and red. Area went from shot site down to knee and half way around thigh. MD diagnosed cellulitis and started Amoxil. Sat no better so started Cefdinir. Mon redness subsided swelling decreased and site remained bruised.									Y	01/03/2008	01/03/2008	0		PUB	PVT	Unknown	None	Unknown			1						1	Cellulitis; Contusion; Erythema; Induration; Swelling	FLU3~SANOFI PASTEUR~U2529AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0303499	01/24/2008	IL	66.0	66		M	01/24/2008	Pt claims he received influenza vaccine at outside hospital 11/23. 11/25 he noted leg weakness and could not walk without assisstance.  He was admitted 11/27 with leg weakness, hand, feet and mouth numb, and difficulty swallowing.  Pt also developed respiratory failure.  Guillain Barre was diagnosed per EMG and nerve conduction studies and pt hospitalized 11/27/07-1/22/08. Pt transferred to outside rehabilitation facility. 2/20/08-records received for DOS 11/27/07-01/22/08-DC DX: Guillain Barre syndrome. Respiratory failure, ventilator associated pneumonia, ARDS. Atrial fibrillation with RVR. Acute renal failure. C-difficule diarrhea. Citrobacter UTI. Anemia. Bilateral lower extremity DVTs. Mild to moderate mixed hearing loss. Type two diabetes mellitus. Stage two decubitus ulcer. Neuropathic pain. Right middle lobe abscess. Two days after vaccination developed progressive bilateral lower extremity and bilateral upper extremity weakness and dificulty standing. Previous exploratory laparotomy for small bowel obstruction 11/07. Trached. Transferred to rehabilitation facility.			Y		Y	55			Y	11/23/2007	11/25/2007	2	EMG 2/20/08-records received-Bronchoscopy E. coli, citrobacter and Klebsiella. G Tube placement.  EMG and nerve conduction studies positive for Guillain Barre.	UNK	UNK	amiodarone, amlodipine, aspirin, atenolol, Plavix, Colace, Nexium, Proscar, folic acid, furosemide, Xopenex, Hyzaar, Paxil, potassium, Flomax	Being discharged from outside hospital after small bowel obstruction	Hospitalized 11/7 - 11/23 for small bowel obstruction and laparotomy. Allergies in chart to clonidine, iodine.  History of cervical spinal fusion with ACDF at C6-7 12 years ago. Also history of CAD with CABG and stenting, chronic renal insufficiency, HTN. 2/20/08-records received-PMH: high blood pressure. Coronary artery disease status post coronary artery bypass grafting 1991 and stenting times two in 2004. Atrial fibrillation and hyperlipidema. Cervical spinal fusion with ACDF. Lumbar laminectomy. Hypokalemia. Chronic renal failure. Allergies to IV dye and clonidine.			1						1	Dysphagia; Electromyogram abnormal; Gait disturbance; Guillain-Barre syndrome; Hypoaesthesia; Hypoaesthesia oral; Muscular weakness; Nerve conduction studies abnormal; Respiratory failure	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0303501	01/24/2008	WA	7.0	7		M	01/24/2008	Site swelling and redness to the Upper Left Arm (back of arm). Ibuprofen was given to child by his parent along with using cool compresses to injection site. The injection was given at 10:45am.									Y	01/22/2008	01/23/2008	1	Site Reaction (local)	UNK	UNK		no present illnesses	none			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2509AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB214AA~UNK~IM~~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~Z1069~UNK~SC~~POLIO VIRUS, INACT. (IPOL)~1|VARCEL~MERCK & CO. INC.~1514U~UNK~SC~~VARICELLA (VARIVAX)~1	USA		Influenza
0303502	01/24/2008	WA	7.0	7		M	01/24/2008	Received 2nd flu vaccine dose when already received on 11/01/07.  No reaction noted.									U	01/24/2008	01/24/2008	0	none needed	UNK	UNK		none				1						1	Inappropriate schedule of drug administration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80822~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0303506	01/24/2008	AZ	14.0	14		F	01/24/2008	Patient went to Doctor for routine Physical Examination.  Approx. 5 minutes after given Gardasil Shot, patient lost consciousness.  During the loss of consciousness, her arms and legs seized up and her hands seized up at the wrists.  She was making a gurgling noise with her mouth and her head/neck were seizing, bringing her chin down to her chest.  After about 60 seconds, the nurses and doctor were able to revive her by leaning her forward and calling her name twice.  Patient is a very healthy female with no existing medical conditions and no family history of seizures or fainting spells.									Y	01/21/2008	01/21/2008	0		UNK	UNK	None	None	None			1						1	Convulsion; Loss of consciousness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~UNK~~~MENINGOCOCCAL (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~~~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0303522	01/24/2008	NE		0	.0	U	01/24/2008	This case was reported by a pharmacist and described the occurrence of wrong vaccine administered in a newborn subject less than one day old of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline) for prophylaxis. On 21 January 2008, the newborn subject inadvertently received an unspecified dose of Fluarix (unknown) instead of an intended Hepatitis B vaccine. This was considered to be a medication error, as Fluarix is not indicated for use in subjects under the age of 18 years. The newborn was hospitalized following birth and it was unclear at the time of reporting whether the medication error would prolong the subject's stay in the hospital. The reporting pharmacist stated that no patient chart was available, but no adverse events had occurred at the time of this report.					Y	0			U	01/21/2008	01/21/2008	0	UNK	PVT	PVT		Unknown	The newborn subject had no medical history, nor any history of previous influenza vaccinations. The subject was not taking any concomitant medications at the time of vaccination with Fluarix.		A0704954A	1						1	Inappropriate schedule of drug administration; Medication error; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0303523	01/24/2008	TX	8.0	8		F	01/24/2008	(L) facial paralysis. 3/7/08-records received-1/9/08-C/O left side of face crooked when mouth is open. Seen in office on 1/10/08-Bell's Palsy. 1/17/08-left side mouth still swollen. 1/24/08-Bell's Palsy resolving.									Y	01/04/2008	01/04/2008	0	Neg Lyme titer 3/7/08-records received-Lyme disease negative.	PVT	PVT		None	None			1						1	Borrelia burgdorferi serology negative; Facial palsy	FLU3~SANOFI PASTEUR~U2524AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0303564	01/25/2008	MN	0.6	0	.6	M	01/18/2008	Infantile spasms-seizures. Treated with ACTH for 6 weeks. Seizures started one week after vaccinations. Pt did have a temperature of 102 deg (by ear) following vaccines-same day. Treated with Tylenol.  03/10/2008 MR received for DOS 11/22-12/04/2008 with DX: Infantile Spasms. Child presented to ER after several seizure-like episodes with increasing frequency over the past week. Pt stiffens up, then becomes limp for 10-15 seconds. these are occuring in clusters. PE WNL except pt is sleepy following several seizure episodes. EEG shows the presence of an epileptic encephalopathy with clinical infantile spasms correlating with a progressive tendency toward hypsarrhythmia. Tx with B6 and ACTH.					Y	12			U	11/09/2007	11/17/2007	8	EEG. Labs and Diagnostics: Head CT shows increased ventricle size. EEG abnormal x 3. Brain MRI with nild prominence of the frontal horns.  MRS spectroscopy with mild prominence of frontal horns	PVT	PVT	None	None	None. PMH:  None. NKDA.			1						1	Body temperature increased; Convulsion; Electroencephalogram; Infantile spasms	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B124DB~3~UN~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2460BA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0303565	01/25/2008	SC	4.0	4		F	01/25/2008	Fluzone received at 9:00am on 12/14/07. Onset of swelling of hands, face and eyes with fever at 7:00pm.  Benadryl given.  Parent did not take to MD until 12-17-07.  Currently on Clarinex and Benadryl. Parent states still has blotches on hands and feet.  Previously (2 months prior) similar symptoms after eating food from concession stand.  Allergy testing done on 1-7-08 at Hospital. MD does not want child to receive 2nd dose of flu vaccine during this season. Follow-up Information 22-APR-2008: SC0726 - We are only aware of one filing of this report- E20331. Followup required - none. No contraindication to future flu & Td. SC0727 - no future flu vaccine unless MD approves. SC0728 - no followup required. No contraindications for future immunizations. SC0801 - no followup required.				Y					Y	12/14/2007	12/14/2007	0	Allergy testing done 1/7/08	UNK	UNK	None	None	Unknown food allergies but tolerates eggs without problems		SC0727	1						1	Allergy test; Eye swelling; Oedema peripheral; Pyrexia; Rash macular; Swelling face	FLU3~SANOFI PASTEUR~U2501AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0303573	01/25/2008	WA	66.0	66		M	01/25/2008	Pt spouse states extreme redness and swelling at injection site.									Y	01/22/2008	01/23/2008	1		MIL	UNK						1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2561AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1380U~1~SC~LA~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~1568U~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0303589	01/25/2008	NC	56.0	56		F		Hospitalized 2-11-03 to 3-11-03 then went to rehab.  Symptoms - low back pain, weakness.  I am writing concerning my adverse reaction to the flu shot.  I had Guillain-Barre syndrome as a result of having taking it, confirmed by doctor, neurologists.  I am enclosing a copy of the report that was sent to Vaers, by my medical doctor.  I was hospitalized for 1 month, Feb. 11, 2003 - March 11, 2003 CMC 2 1/2 weeks for rehabilitation.  Out-patient also.  I think this is something that should be reviewed.  I would appreciate anything that could be done.  There are side effects you have to have to live with for the remainder of your life.  People have died.  I deal with pain everyday of my life.  If I had not had good insurance, I would have lost everything I own.  I took the flu shot as preventive care, I have asthma, and as a result of taking it almost died.  Please listen or hear me!  I have friends and family members who will not take it after seeing what I have gone thru.  I am blessed to be alive, several doctors have told me this.  Prayers were answered, I can walk, but my legs do get weak, at times almost give away.  I have sensations in my feet and legs.  I live alone, I have limits.  I do what I can when I can.  I am in pain all the time.  I refuse to get addicted to drugs.  Why take them if they don't work.  I want to know what is going on, and I cannot afford to fall and break a bone or worse.  I called one lawyer, his receptionist called me back.  The answer, no one, no lawyer wants to take on a pharmaceutical company.  This was in fall (September) 2003.  This is not right!  This needs to change!  We need a voice.  We need someone to stand up for us.  I have waited to write, I have no one to help me.  I am on my own.  My husband is dead, I live alone.  I don't want sympathy, I just want someone to listen!  I have nothing to lose and hopefully everything to gain.  I had never heard of Guillain-Barre until I had it.  God, help all of us.  To know something caused it how does it make you feel?  Please listen!  Hear me!  I can give you more information about my bout with Guillain-Barre.  It might help others.  Lord, we need all the help anyone can give.  Thank you, hopefully this will be read and passed on to others.  Just listen, if anyone can help us please do so.  P.S. Enclosed report to VAERs.  The only paper I signed was for Medicare to pay.    2/19/08 Reviewed pcp med records for 2002 which reveal patient in usual state of health on day of vax 10/7/02 w/increasing neck & left shoulder discomfort. Meds reviewed & changes made.  Referred for labs.  2/22/08 Received neuro clinic eval of 11/18/2003 which reveals patient experienced LE pain, ascending weakness resulting in total paralysis & weakness of left face.  Had been areflexic at times.  Had received IVIG.  Had residual pain in right chest wall & thigh requiring continued narcotics at present along w/continued fatiguem intermittent numbness & tingling of hand/feet, difficulty w/fine motor control & inability to return to work.    FINAL DX: Guillian Barre syndrome.  2/29/08 Reviewed hospital medical records for 2/11-3/11/2003 admission. FINAL DX: bilateral lower extremity weakness, etiology unestablished; hypo-osmolar hyponatremia, corrected; potassium depletion, corrected; hypocalcemia, corrected; and mediastinal & hilar adenopathy, etiology unestablished. HPI: developed right upper back & right hip pain 2 wks prior to admit which progressed w/weakness of bilateral LEs.  Originally admitted for pain mgt thought to be from spinal DJD.  Anesthesia consult done, epidural injection & multiple trigger point injections done.  Neuro consult done, absent reflexes in LEx, diminished un UEs; sensation diminshed in LEx; dx w/Guillian Barre syndrome.  LP done.  Tx w/IVIG x 5 w/o improvement in weakness.  Nephrology consult done & dx w/SIADH & Eaton-Lambert syndrome.  Pulmonary consult & bronchoscopy/mediastinoscopy done. Oncologist consulted.  Cardiovascular surgery consult done.  Developed confusion, hallucinations & disorientation along w/left facial weakness.  Gradually improved but had continued LE weakness.  Deferred thoracotomy & was transferred to inpatient rehab facility for further strengthening.  2/29/08 Reviewed neurologist & pulmonologist medical records.  Neurology records 3/9/04 through 3/26/2007 reveal patient initially seen in f/u for AIDP.  Progressed well.  Note of 9/21/2006 states GBS now w/leg pain & cramps along w/insomnia.   Pulmonology records 6/9/2004 revealed increased & productive cough, rhinorhea & congestion.  Additional pulmonology records of 3/29/2004 reveal CXR w/RLL atelectasis.			Y		Y	30	Y			10/07/2002			Neuro clinic 11/18/2003 LABS: Prior abnormal EMG's reviewed which showed steady slow improvement.  CSF results reviewed which revealed protein (H).  Hospital 2/11-3/11/2003 LABS: Admit CBC & sed rate WNL.  Initial sodium 126 (L) & dropped to 114, potassium 3.3 (L), cholride 89 (L), calcium 8.2 (L).  CSF protein 165 (H), glucose 68 (N), RBC 225 (H), WBC 0 (N), c/s neg, ACE 17 (H).  TSH 6.58 (H).  Vit B12 1500 (H).  CKMB & troponin WNL.  24-hr urine cortisol 367.2 (H).  Urine c/s (+) yeast.  CT of chest/abd/pelvis revealed extensive mediastinal & bilateral hilar lymphadenopathy c/w sarcoidosis vs small cell carcinoma; bilat pleural effusions, left basilar atelectasis & right basilar consolidation.  MRI brain c/w small vessel changes.  Bronchial washings (+) e. coli.  Mediastinal lymph node biopsy showed reactive lymph node, neg for sarcoidosis or malignancy. Neuro/Pulm clinic   Neuro & Pulm clinic LABS: EMG of  3/18/2004 & 9/26/2006 WNL.  CXR 6/9/2004 revealed acute bronchitis.  PFTs revealed mild obstruction.  CT of chest done 3/31/2004 revealed resolution of bibasilar atelectasis/consolidations & effusions.  Bulky mediastinal & hilar adenopathy unchanged.	UNK	UNK			PMH: osteoarthritis; constipation; HTN; thyroid ca s/p total thyroidectomy; bipolar disorder; reactive airway disease; mildly obese; allergies demerol & PCN; cervical stenosis w/radiculopathy; LBP; BSO secondary to fibroids; recent static chest mass; depression w/prior hospitalizations & suicide attempt; osteoporosis; extensive DJD of spine; c-spine  herniated disc; fibromyalgia.			1						1	Loss of control of legs	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0303593	01/25/2008	FL	44.0	44		M	01/25/2008	Pneumococcal vaccine causes a localized sting on site of injection also a golf size knot. One hour later a localized area of redness and swelling and pain. Stiff arm end musles in arm very hot to the thouch. Also a fever of 100'4.  1/29/08 Reviewed hospital medical records which reveal that on 1/10/08 patient experienced abdominal pain & rectal bleeding.  Admitted 1/10-1/14/2008.  GI consult done & revealed epigastric pain, reflux, constipation & dysphagia.  No record of vaccinations w/hospitalization.  1/16/08 Returned to ER w/pain & swelling of left deltoid which stated was from flu shot received 1/14 in hospital.  Exam revealed erythematous rash, pain, paresthesias, swelling of left bicep & tricep w/decreased ROM.  Tx w/oral antibiotics & d/c to home on continued antibiotics to return next day for re-check. FINAL ER Dx: cellulitis left upper arm. 1/17/08 Returned to ER for re-check.  Exam revealed left upper arm mostly in left posterior elbow was red, hot, swollen & painful w/decreased ROM.  Tx w/additional antibiotics.  To return if worsened. FINAL ER Dx: abscess, allergic reaction, cellulitis & local reaction to flu shot.			Y	Y	Y				N	01/14/2008	01/14/2008	0	blood  cultures LABS: EGD revealed distal esophagitis, gastritis of antral region & duodenitis of bulb.  Biopsy done.  Colonoscopy revealed internal hemorrhoids & multiple polyps.  Biopsy done. LABS: x-ray left upper arm WNL.	UNK	UNK		Abdominal pain and rectal bleeding	PMH: anxiety, panic attacks, heart palpitations, HTN, GERD, gastritis & prior GI bleeding, hemorroids.  Smoker.  Daily ETOH use.  Morbidly obese.  Had received flu vax 8/06 & pneumo vax 8/05.			1						1	Blood culture; Injection site erythema; Injection site mass; Injection site pain; Injection site swelling; Musculoskeletal stiffness; Pyrexia; Skin warm	FLU3~SANOFI PASTEUR~U2479AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1481U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0303611	01/25/2008		55.0	55		F	01/28/2008	We received from a physician via Sanofi Pasteur and the Medical agency the following information on 15 JAN 2008: A 55-year-old woman, born on 03 SEP 1952, diagnosed in SEP 2007 with a stage III gastric carcinoma and a status post partial gastrectomy with lymph node dissection, was vaccinated with Fluvirin, batch-no. 78479, i.m. into the left arm on 07 NOV 2007. She had been doing well with her nutrition as an outpatient. Two hours after the vaccination (after 3-4 hours was also reported) the patient suffered from nausea and excessive salivation with vomiting which intensified and led to dehydration and malnutrition. She was admitted to the hospital from 12 NOV-23 NOV 2007 to initial total parenteral nutrition (TPN) and to evaluate to cause for her symptoms. CT scans of the chest, abdomen and pelvis were performed which showed no evidence of recurrence of her cancer. She had an upper GI endoscopy which showed evidence of bile acid reflux with significant esophagitis and no definite evidence of recurrence of tumor and no evidence of stricture at the surgical anastomotic site. It was felt that the patient's nausea and vomiting was predominantly due to bile acid reflux following her recent surgery. She was initially treated with Carafate (sucralfate), high dose Protonix (pantoprazole) and intravenous Reglan (metoclopramide). With this, there was some modest improvement in her nausea and vomiting. Condition on discharge: improved with only mild nausea and vomiting. Company assessment: Seriousness criterion: hospitalisation. Causality: unrelated, due to biliary reflux following her recent partial gastrectomy. Expectedness assessment according to manufacturer label: The reported symptoms are due to the persistent symptomatic not expected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measure necessary. Agency-no. NA08-000162 Sanofi Pasteur no.: 2007-03865 (0)					Y	11			N	11/07/2007	11/07/2007	0		OTH	OTH	No other medications	Unknown	Gastroesophageal Reflux Disease GERD; Gastric Cancer Stage III Adenocarcinoma of the stomach stage III; Barrett's Oesophagus; Historical Condition Gastrectomy; Hypertension		MA20080046	1						1	Computerised tomogram normal; Dehydration; Endoscopy abnormal; Gastrooesophageal reflux disease; Malnutrition; Nausea; Oesophagitis; Salivary hypersecretion; Vomiting; X-ray gastrointestinal tract abnormal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78479~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0303613	01/25/2008	MI	32.0	32		F	12/07/2007	Client received flu vaccine at 400PM on 12/6/07.  She awoke at 200AM with shaking chills and total body aches.  At 400AM she awoke drenched in sweat, states this lasted until 600AM.  When she called heath department she c/o soreness.  Client phoned CDC and was informed to call the VAERS line which did not answer.  Called health department at 1035AM.									Y	12/06/2007	12/07/2007	1	None	PUB	PUB	Ortho Tri-Cyclen; levothyroxine; Valtrex (PRN)	None	Asthma	nauseous~Rabies (no brand name)~1~28.00~In Patient	MI2007005	1						1	Chills; Myalgia; Night sweats; Pain; Tremor	FLU3~SANOFI PASTEUR~U2440AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0303614	01/25/2008	MI	59.0	59		M	11/29/2007	2 days after flu vaccination client became nauseated (lasting 1 1/2 days). He also developed pain at the injection site with bruising-pain in (L) and (R) arms, esp. elbows and spine. Sneezing and runny nose also continues. Very fatigued which is not normal for him. Symptoms continue.									N	11/19/2007	11/21/2007	2		PUB	PUB		None	Diabetes controlled with diet and exercise		M12008004	1						1	Bone pain; Fatigue; Injection site bruising; Injection site pain; Nausea; Pain in extremity; Rhinorrhoea; Sneezing	FLU3~SANOFI PASTEUR~U2523AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0303616	01/25/2008	PA	59.0	59		F	01/19/2008	Fluzone injection 11/1/07 - noted more discomfort at injection site than usual.  Left deltoid pain did not resolve - no redness or swelling noted.  Tender to palpation.  Tx: local ice packs, may use small lidocaine patch.				Y						11/01/2007	11/02/2007	1	X-ray left humerus - (R/O CA bone mets) - negative report.	OTH	PUB	Flovent and Albuterol, Maxide, Hawthorne Berry Supplement	None	Right breast CA; Hypertension; Asthma			1						1	Discomfort; Injection site pain; Pain in extremity; Tenderness; X-ray limb	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA030AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0303620	01/25/2008	PA	50.0	50		F	12/06/2007	Upper arm pain - shoulder and neck within one hour of flu vaccine being administered. Duration of 24-36 hrs. Ibuprofen and ice as treatments.									Y	11/06/2007	11/06/2007	0	N/A	PVT	OTH	MVI, Vit E, Caltrate, ASA, Ibuprofen, Vytorin, Claritin	None	Penicillin and Sulfa drugs			1						1	Musculoskeletal pain; Neck pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0303627	01/25/2008	NJ	50.0	50		F	11/08/2007	Itchy skin, (face, right shoulder).  3 bite like hives on right upper arm, itchy eyes.  Dry mouth and lips.  Right side of throat felt strange.									Y	11/06/2007	11/06/2007	0	None	PUB	UNK	None	None	Previously positive TST			1						1	Dry mouth; Eye pruritus; Lip dry; Pruritus; Throat irritation; Urticaria	FLU3~SANOFI PASTEUR~U2529AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0303629	01/25/2008	FL	71.0	71		M	01/22/2008	On October 25, 2007, I received the Zostavax shingles vaccine.  This shot was given in my right deltoid.  The vaccine was Merck lot #1081U, expiration January 12, 2009.  At the same time, I was given a flu vaccine in my left deltoid.  This vaccine was Novartis lot #80074, expiration June 30, 2008.  My wife received the same vaccines.  My wife's only reaction was a very sore arm with a slight red swelling.  This decreased and the arm returned to normal in about four days.  However, my reaction was quite severe.  Over the next several days I began to develop a red rash.  I have enclosed five photos of myself taken in a relaxed posture.  The date and file number are on the back of the photos.  Photo JWG-11062007-0022 is a photo of my back made twelve days after receiving the vaccine.  This photo was made just before going to be treated by my dermatologist on November 6, 2007.  On this day she took a biopsy of the large red spot near my left shoulder blade.  The next four photos JWG-11162007-13, 14, 16, and 22 show my front, sides, and back, ten days later.  This is when the rash peaked.  From this time the rash continued to improve until my skin was back to near normal by January 1, 2008.  The rash also covered my hips and legs down to my ankles, even though that does not show well in the photos.  However, you can see a red spot on the front of my left ankle in photo -13 and on the rear of my right ankle in photo -22.  I am still being treated for the after effects of this vaccine.  Other visit dates included November 19, 27, and December 20, 2007.  A second biopsy was made on the bright red spot near my right shoulder blade on December 20.  Both Dermatopathology Reports came back with the same diagnosis: Nummular/contact dermatitis.  The epidermis shows parakeratosis, serum exudates, spongiosis, and superficial chronic inflammatory infiltrate.  My treatment of this rash since November 6 included covering the rash area with Cetaphil cream and/or lotion and Triamcinolone Acetonide Cream USP, 0.1%.  The very red spots were treated with Clobetasol Propionate Cream USP, 0.05%.  This procedure was repeated morning and evening.  There was no pain associated with this rash, but it was quite itchy without the above treatment twice a day.  However my skin was extremely dry, scaly, and chapped.  The dry skin peeled easily.  I did not have my normal great feeling and I was somewhat mentally depressed over my skin condition, especially since I could not go to the gym to work out and swim as I frequently did.  As of this writing on January 22, 2008, my skin is well on its way to normal.				Y					Y	10/25/2007	10/26/2007	1	Skin, left cheek - actinic keratosis LN2 if residue; Skin, left upper back - nummular/contact dermatitis Triam 0.1% cream	PVT	PVT	Bemcar, Norvasc, Zocor	None	None			1						1	Actinic keratosis; Dermatitis contact; Dry skin; Pruritus; Rash erythematous; Skin exfoliation	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80074~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARZOS~MERCK & CO. INC.~1081U~1~UN~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0303632	01/25/2008	NC	58.0	58		F	01/09/2008	Fever 101+, pain in both legs, paralysis of right leg proceeding to paralysis of both legs by 11/20/07.  Slow recovery with weakness in quads of both legs.  Continued fatigue/weakness in right leg.  Currently in physical therapy.  Has slight right leg limp.				Y					U	11/14/2007	11/18/2007	4	Lower spine/hip X-rays; blood panels (3).	OTH	PUB	Synthroid; HCTZ	None	Hypertension; hypothyroid; arthritic right hip			1						1	Asthenia; Blood test; Diplegia; Fatigue; Gait disturbance; Pain in extremity; Pyrexia; Spinal X-ray; X-ray of pelvis and hip	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79720~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0303633	01/25/2008	NH	37.0	37		F	11/27/2007	Hives on face flu x 6 days.									Y	11/14/2007	11/24/2007	10		PVT	OTH	Topamax 200 mg QD; Singular 10 mg QD; Zyrtec 10 mg QD; Cymbalta 120 mg QD	None	asthma		NH0801	1						1	Influenza; Urticaria	FLU3~SANOFI PASTEUR~U2439AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0303638	01/25/2008	FL	26.0	26		F	01/25/2008	Localized redness, swelling of upper arm. Pt sought treatment Wed. sent home with Motrin. Told to apply ice PRN				Y					Y	01/16/2008	01/17/2008	1	None	MIL	MIL	None	None	None			1						1	Erythema; Oedema peripheral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA071AA~1~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0303647	01/25/2008	FL	15.0	15		F	01/25/2008	Immediately after receiving the influenza vaccine pt c/o feeling nauseous and seeing black and blue.  Within 2 mins pt lost consciousness after her eyes rolled back and after becoming pale and diaphoretic.  911 called.  Pt regained consciousness before EMS arrived. 10 mins after EMS arrived pt lost consciousness again, recovered in 1 min.  Pt taken to ER.  Pt recovered before being taken to the ER.				Y					Y	01/25/2008	01/25/2008	0	EMS-BP (N); temp (N); blood sugar (N); EKG (N); IVF administered before pt taken to ER.	OTH	PVT		None	None per pt and parent.	fainting~Vaccine not specified (no brand name)~UN~4.00~In Patient		1						1	Blood glucose normal; Blood pressure normal; Body temperature; Chromatopsia; Electrocardiogram normal; Gaze palsy; Hyperhidrosis; Immediate post-injection reaction; Loss of consciousness; Nausea; Pallor	FLU3~SANOFI PASTEUR~U2476GA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0111958	01/28/2008	NC	36.0	36		F	01/23/2008	Got flu shot Nov. 1991. I've been 100 disabled ever since. Atty filled out papers for reporting system years ago! We've heard nothing. The doctors was suppose to fill this out when it happened. 1/19/2009 Multiple chemical sensitivity syndrome (I just found out I have this and probably had it then) reaction to vaccines, sun, alcohol, estrogen, caffeine, recourant yeast infections, reactions to sulfa drugs certain antibiotics, asthma illness and difficulty breathing, insoomnia, concentration, delerium, some paranoia, memory loss, migraines, nausea, abdominal pain, chronic fatigue syndrome, aching joints, muscles, irritating eyes, nose, ears, throat, skin, impaired balance, increased sensitivites to odors and loud noises bright lights, touch, fibromyalgia, heat and cold, liver has trouble getting rid of toxins.			Y	Y				Y	N	11/01/1991	11/02/1991	1		PVT	PVT			Had to get out of military due to fatigue Aug 1988.			1						2	Abdominal pain; Alcohol problem; Amnesia; Arthralgia; Asthma; Balance disorder; Chronic fatigue syndrome; Delirium; Disability; Disturbance in attention; Drug hypersensitivity; Dyspnoea; Eye irritation; Feeling of body temperature change; Fibromyalgia; Fungal infection; Insomnia; Liver disorder; Migraine; Multiple chemical sensitivity; Myalgia; Nausea; Paranoia; Photosensitivity reaction; Skin irritation; Throat irritation; Activities of daily living impaired	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Life Threatening,Disabling	Influenza
0299458	01/28/2008	MD	41.0	41		M	09/28/2007	Initial report received on 15 August 2007 from a health care provider.  A 41-year-old male patient had received an injection of Decavac, lot number not reported; an injection of IPOL, lot number not reported; an injection of Menomune, lot number not reported; an injection of Typhim VI, lot number not reported; an injection of Fluzone SV 2006-2007, lot number not reported; and an injection of Havrix, manufacturer GSK, lot number not reported; on 20 December 2006.  Routes and sites of administration were not reported.  The patient had received the vaccinations for travel out of the country where he visited for two weeks.  Illness at the time of vaccination was unknown.  Almost immediately post-vaccination, the patient complained of dark circles under his eyes, bags under his eyes, and a permanent tired line in his face.  Per a letter from the patient dated 13 August 2007, These side effects have not improved or diminished to date.  At the time of this report, the patient had not recovered.  A new version was created for this case on 31 August 2007 to add that the reporter for this case is the same as for case 2007-03017.  No relevant medically significant information was added.  Follow-up information was received from the health professional on 24 September 2007.  Decavac (lot number U1880DA) was given in the left deltoid; Fluzone (lot number A203BA) was given in the left deltoid; IPOL (lot number Z0306) was given subcutaneously in the right arm; Menomune (lot number UE766AA) was given subcutaneously in the left arm; Typhim (lot number Z0572) was given in the right deltoid; and Havrix (GSK, lot number AHAVB109CB) was given in the right deltoid.  The patient's date of birth was provided as 28 May 1965.									N	12/20/2006	12/20/2006	0		PUB	PUB	VALTREX	Illness at the time of vaccination was unknown.	The patient had an allergy to aspirin and unknown other medical history.  Illness at the time of vaccination was unknown.  Other medications included Valtrex.		200702806	1						2	Dark circles under eyes; Eye swelling; Skin wrinkling	DT~SANOFI PASTEUR~U1880DA~UNK~UN~LA~DT ADSORBED (DECAVAC)~2|FLU3~SANOFI PASTEUR~A203BA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB109CB~UNK~UN~RA~HEP A (HAVRIX)~2|IPV~SANOFI PASTEUR~Z0306~UNK~SC~RA~POLIO VIRUS, INACT. (IPOL)~2|MEN~SANOFI PASTEUR~UE766AA~UNK~SC~LA~MENINGOCOCCAL (MENOMUNE)~2|TYP~SANOFI PASTEUR~Z0572~UNK~UN~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~2	USA		Influenza
0303731	01/28/2008	TN	57.0	57		F	01/16/2008	Great pain in both legs moving upward, difficulty getting up and down out of chair, bed, etc.  02/12/2008 MR received for DOS 11/29-12/03/2007 with Final DX:  Guillain-Barre Syndrome 2' to influenza vaccination.  HTN. DM. Stable 4 mm noncalcified LLL nodule per CT abd/pelvis.  Stable hepatic lesions c/w proteinaceous cyst. Pt presented to MD with pain in legs, weakness and inability to get out of a chair w/o using arms and ambulation. Pain noted in upper limb girdle/shoulder.  PE (+) for 1+ DTRs with normal strength noted. Txd with IVIG. x 5 days with good response. 2/15/2008 Pt improved to date, but not 100%. Follow-up Information 09-MAY-2008: I have not regained the total use of my legs that I had before the flu shot. I still have great difficulty getting up and down from a chair. I cannot drive long distances. My shoulders are in pain from the effort it takes to get my legs up from a seated position. There has not been one day free of pain or any way normal since that horrible shot. The only good thing is that I voluntarily did it; I would hate someone if I had been forced to have had it. It has been six months, I am now trying accupuncture and deep massage. I am thousands of dollars in debt from this.				Y	Y	5			N	11/16/2007	11/19/2007	3	Spinal tap, nerve tests, mild Guillain-Barre syndrome per doctors. Labs and Diagnostics: EMG/NCS(+) for mild, diffuse sensory motor peripheral neuropathy. No demyelination or lumbosacral radiculopathy.  Blood sugars increased, HgbA1c 7.8, CBC with WBC 4.6, RBC 3.89, Hgb 11.8, Hct 35.7. CT abdomen/pelvis with stable hepatic lesions.	OTH	PVT		None	None. PMH:  HTN, Liver cyst. Gall bladder surgery 2006 (verified not GBS). Retinal surgery.			1						1	Diabetes mellitus; Dysstasia; Guillain-Barre syndrome; Hepatic lesion; Lumbar puncture; Mobility decreased; Pain in extremity; Transfusion; Activities of daily living impaired; Asthenia; Blood product transfusion; Gait disturbance; Guillain-Barre syndrome; Hypokinesia; Hypotonia; Muscle atrophy; Muscular weakness; Musculoskeletal pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA075~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0303733	01/28/2008	CA	19.0	19		M	01/24/2008	Patient admitted for Acute disseminated encephalomyelitis.   1/29/08 Case closed w/medical records that accompanied report which reveal that patient experienced sore throat, congestion & persistent cough when seen 10/8/07.  Treated symptomatically & improved initially.  Returned to clinic on 10/16/07 w/urticarial rash thought to be caused by fabric softener & resolved with change.  Then received multiple vax on 10/16/07.  Returned to clinic 10/19/07 w/worsening cough, fever, sore throat & nasal discharge.  Tx symptomatically & improved.  On 10/26/07 patient had HA, neck stiffness, slurred speech, confusion, collapsed, was stuporous, incontinent of urine & falling asleep on his feet.  Taken to ER & transferred to higher level of care.  Temp in ER 103.2.  Had LP in ER which showed CSF WBC 2240 w/82% polys.  Admitted 10/26-11/5/2007 in ICU.  Was stiff, unresponsive to stimuli, wringing his hands & shaking.  Tx w/IV antibiotics, antivirals & steroids & placed in isolation.  ID & neuro consults done.  Gradually improved & was d/c to home w/ID & Neuro outpatient f/u.  ID outpatient vs of 11/20 revealed patient quite weak w/mild stiff neck, numbness of hands, weak grip, memory & concentration problems.  Neuro outpatient vs of 11/21 revealed patient continued to improve but concerned about cognitive function.  Referred for neuropsych & congnitive rehab.  As of 11/30, had weakness of bilateral extremities, more in legs, weak hand grasp, decreased sensation in fingers, easy fatigue & some difficulty w/memory & concentration. FINAL DX: ADEM.				Y	Y	10			U	10/16/2007	10/19/2007	3	Diagnostic Tests: 29 Oct 2007: MRI Brain: Impression - Diffuse white matter increased flair signal without enhancement. This pattern is most suggestive of ADEM. This pattern could also be seen in the setting of Lyme Disease. Labs: 11/1/07: CSF: VZV PCR - negative; HSV 1/2 PCR - negative; Enterovirus RNA - negative; CSF Glucose - 72 (40-70); Protein 41.0; 11/1/07 CBC - WBC 6.4 (4-10.5); H/H 13.9/40.6; RBC 4.59; 10/31/07 Lyme Ab (serum) - positive LABS: CT scan of 10/27 revealed sinus disease.  MRI 10/29 c/w ADEM.  Repeat MRI 11/16 much improved. CSF c/s neg. 3/25/08 Receivd additional labs from CDC.  CSF: WBC 36 (H), RBC 4 (H), lymphos 39%, monos 51%, neutros 10%.  MRI 10/29 revealed diffuse white matter change c/w acute disseminated encephalomyelitis.  Yellow Fever Lab Results from CDC lab: Day 6 serum negative for Ab and RT-PCR; D26 serum positive for IgM Ab PRNT 1:10240; D0 CSF positive for IgM Ab but not confirmed with PRNT	MIL	MIL	Guaifenesin 600 mg ER; Pseudoephedrine HCL ER, Oxymetazoline HCL spray	(Seen on 19 Oct for URI); Urticarial rash	Essentially negative PMH			1						1	CSF culture negative; CSF glucose increased; CSF protein normal; Cognitive disorder; Dysarthria; Enterovirus serology test negative; Fatigue; Haematocrit; Haemoglobin; Laboratory test normal; Leukoencephalomyelitis; Musculoskeletal stiffness; Nuclear magnetic resonance imaging brain abnormal; Polymerase chain reaction; Protein total; Red blood cell count; Serology positive; Stupor; Tremor; Urinary incontinence; White blood cell count normal; Bacterial test negative; Blood chloride decreased; Blood cortisol decreased; Blood creatinine decreased; Blood homocysteine; Blood potassium decreased; Blood sodium decreased; Blood urea decreased; Body temperature increased; Borrelia burgdorferi serology; CSF cell count normal; CSF glucose increased; CSF protein increased; CSF white blood cell count increased; Computerised tomogram abnormal; Culture negative; Culture throat negative; Disturbance in attention; Dyspnoea; Enterovirus serology test negative; Epstein-Barr virus antibody positive; Full blood count; Glasgow coma scale; Gram stain negative; Granulocyte count increased; Grip strength decreased; Haematocrit decreased; Haemoglobin decreased; Headache; Incontinence; Laboratory test abnormal; Lethargy; Leukoencephalomyelitis; Lumbar puncture; Lymphocyte percentage; Mechanical ventilation; Memory impairment; Metapneumovirus infection; Monocyte percentage increased; Muscular weakness; Musculoskeletal stiffness; Neurological examination normal; Nuclear magnetic resonance imaging abnormal; Parvovirus B19 serology; Polymerase chain reaction; Red blood cells CSF positive; Respiratory syncytial virus serology; Rhinorrhoea; Sensory loss; Syncope; Unresponsive to stimuli; Varicella zoster serology negative; Viral test negative; Virus serology test negative; White blood cell count normal; Antibody test negative; Blood chloride decreased; Blood cortisol decreased; Blood creatinine decreased; Blood culture negative; Blood glucose increased; Blood immunoglobulin M; Blood potassium decreased; Blood sodium decreased; Blood urea decreased; Body temperature increased; Borrelia burgdorferi serology positive; CSF cell count increased; Chest X-ray normal; Computerised tomogram abnormal; Culture negative; Culture throat negative; Disturbance in attention; Dyspnoea; Epstein-Barr virus antibody positive; Glasgow coma scale; Gram stain negative; Haematocrit normal; Haemoglobin decreased; Headache; Herpes simplex serology; Incontinence; Lethargy; Leukoencephalomyelitis; Lumbar puncture; Lymphocyte percentage; Mechanical ventilation; Meningitis; Monocyte percentage increased; Muscular weakness; Musculoskeletal stiffness; Mycoplasma serology; Neurological examination normal; Nuclear magnetic resonance imaging abnormal; Parvovirus B19 serology; Pharyngolaryngeal pain; Productive cough; Protein total increased; Pyrexia; Rash pruritic; Red blood cell count increased; Respiratory tract congestion; Rhinorrhoea; Sensory loss; Syncope; Syphilis test negative; Tonsillar hypertrophy; Unresponsive to stimuli; Varicella zoster serology negative; Viral infection; White blood cell count increased; White blood cell count normal; Yellow fever	FLUN3~MEDIMMUNE VACCINES, INC.~500485P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB100AA~1~UN~UN~HEP A + HEP B (TWINRIX)~1|IPV~UNKNOWN MANUFACTURER~Z0421~1~UN~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~1|TD~SANOFI PASTEUR~AC52B024AA~1~UN~UN~TD ADSORBED (NO BRAND NAME)~1|YF~SANOFI PASTEUR~UE912AA~1~UN~UN~YELLOW FEVER (YF-VAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500485P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB100AA~UNK~UN~UN~HEP A + HEP B (TWINRIX)~2|IPV~SANOFI PASTEUR~Z0421~UNK~UN~UN~POLIO VIRUS, INACT. (IPOL)~2|TD~SANOFI PASTEUR~AC52B024AA~UNK~UN~UN~TD ADSORBED (NO BRAND NAME)~2|YF~SANOFI PASTEUR~UE91211~UNK~UN~UN~YELLOW FEVER (YF-VAX)~2|FLUN3~MEDIMMUNE VACCINES, INC.~500485P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB100AA~UNK~UN~UN~HEP A + HEP B (TWINRIX)~3|IPV~SANOFI PASTEUR~Z0421~UNK~UN~UN~POLIO VIRUS, INACT. (IPOL)~3|TD~GLAXOSMITHKLINE BIOLOGICALS~AC52B024AA~UNK~UN~UN~TD ADSORBED (DITANRIX)~3|YF~SANOFI PASTEUR~UE912AA~UNK~UN~UN~YELLOW FEVER (YF-VAX)~3	USA	Hospitalisation	Influenza
0303745	01/28/2008	WA	67.0			F	01/23/2008	Patient came in 1/22/08 indicated she had had some twinges in arm when she moves it a certain way since she has had her flu shot.  Said it is there for just a little bit and then goes away.									N					OTH	OTH						1						1	Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA305AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0303746	01/28/2008	CA	2.0	2	.1	M	01/22/2008	Got flu shot L thigh a week ago, then developed 3-4 red, blanching 8-10 mm sl. raised lesions, which may be tender.									N	01/10/2008	01/16/2008	6	None	PVT	UNK		No	Iron deficiency anemia			1						1	Erythema; Pallor; Skin lesion	FLU3~SANOFI PASTEUR~U2524AA~UNK~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0303750	01/28/2008	KY	1.0	1	.0	F	01/24/2008	Received Varivax vaccine on 1/11/08.  Fever on 1/19/08 102.  Low grade on 1/20/08.  1/22/08 - cranky, no fever.  1/23/08 - cried for 2 hours, no fever, 1 small bump on right cheek.  1/24/08 - left arm with red papule at vaccine site, right cheek with 8 red papules.  Seen in office.  Impression - Varivax rash.									U	01/11/2008	01/19/2008	8		PVT	PVT	None	None	None			1						1	Crying; Injection site papule; Irritability; Pyrexia; Rash papular; Rash vesicular	FLU3~SANOFI PASTEUR~U2464AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1307U~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B54014D~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1559U~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0303753	01/28/2008	CA	59.0	59		F	01/18/2008	Pt. came in on 11/7/07 with Lt shoulder pain x6 days.  Lt intrascapular pain radiates into Lt shoulder, down arm.  Pain lasting 1 month, severe.  R/O thoracic outlet syndrome.  Toradol 60 mg IM, Neurontin, Vicodin, ibuprofen.  EKG done WNL, X-ray and eval of cervical spine, Varicella titer.  Ret to physical therapy.									Y	10/30/2007	11/01/2007	2	EKG done WNL, X-ray and eval of cervical spine, Varicella titer.	OTH	PUB	Glucophage; Vasotec; Pravachol; Hutz.	C/O increased nasal discharge - seasonal allergies	DMII; HTN; hyperlipidemia; chronic back pain			1						1	Electrocardiogram normal; Laboratory test; Musculoskeletal pain; Pain in extremity; Thoracic outlet syndrome; X-ray	FLU3~SANOFI PASTEUR~U2443AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0303754	01/28/2008	CA	0.6	0	.6	F	01/18/2008	Patient 2nd flu shot, became lethargic, felt warm, developed fever.  reduced PO - screaming, crying, heavy breathing.  Began to have emesis.  2 days later, still with fever, went to ER.  Mom concerned patient received incorrect dose of vaccine as documentation was incorrect.				Y					Y	12/06/2007	12/06/2007	0	RSV neg	PVT	OTH		None	None			1						1	Crying; Hyperventilation; Lethargy; Oral intake reduced; Pyrexia; Screaming; Skin warm; Virus culture negative; Vomiting	FLU3~SANOFI PASTEUR~U2458CB~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0303756	01/28/2008	CA	4.0	4		F	01/18/2008	Left deltoid erythema, warmth, induration & bruising over 48 hrs - ice & ibuprofen.									U	01/16/2008	01/17/2008	1	None	PVT	OTH		None	None	sterile abscess~DTaP (no brand name)~5~4.00~In Sibling		1						1	Injection site bruising; Injection site erythema; Injection site induration; Injection site warmth	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B062AA~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2515AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0169~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1228U~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0303763	01/28/2008	WA	65.0	65		M	01/28/2008	Flu and pneumonia shots 4pm Wednesday 23rd January. 7pm Thursday 24th temperature of 102.9, rash? and tenderness.  Treated with Theraflu and ginger tea.  Major night sweat - fine in morning.									Y	01/23/2008	01/24/2008	1		UNK	UNK	blood pressure	end of cough		none~ ()~~0.00~Patient		1						1	Body temperature increased; Night sweats; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0303774	01/28/2008	SC				U	01/28/2008	This case was reported by a healthcare professional via a sales representative and described the occurrence of anaphylactic reaction in a subject of unspecified age and gender who was vaccinated with Flulaval for prophylaxis. On an unspecified date between the end of November 2007 until 18 January 2008 the subject received unspecified dose of Flulaval (.5 ml) from lot number AFLLA032AA. At an unspecified time after vaccination with Flulaval, the subject experienced anaphylactic reaction due to respiratory distress and pharmaceutical product complaint. The subject presented to the emergency room and then was hospitalised. The healthcare professional considered the events were life-threatening and disabling. At the time of reporting the outcome of the respiratory distress and anaphylactic reaction were unspecified. It was also noted that the Flulaval had not been compromised and had been stored properly. The reporter questioned if issues with this lot number had been reported by other facilities or was her facility the only one. Lot number AFLLA032AA.			Y	Y	Y	0		Y	U				UNK	OTH	OTH		Unknown	The reporter also stated that multiple subjects experienced an adverse event. Details of this are found in case number A0705208A.		A0704660A	1						1	Anaphylactic reaction; Pharmaceutical product complaint; Respiratory distress	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA032AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0303783	01/28/2008	MI	38.0	38		M	01/28/2008	Pain in arm and limited movement of shoulder.									U	01/10/2008	01/10/2008	0		OTH	PVT						1						1	Hypokinesia; Pain in extremity; Arthralgia; Hypokinesia; Joint range of motion decreased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU319BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA319BA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA		Influenza
0187849	01/29/2008	PA	9.0	9		F	01/16/2008	Received immunizations during a well child visit, noted itchy eyes before leaving office, left office, walked a block, sxs of itchy throat, chest tightness, facial swelling, returned immediately to office, brought into a room, given albuterol neb for expiratory wheeze, hives noted over body were worsening, given 0.2 mL of 1 mg/mL of epinephrine 1:1,000 Sub-Q and 2 mg/kg of Orapred.  EMS contacted, given IM Benadryl, observed at hospital for ~5.5 hrs.  D/C to home, seen back in clinic next day and still well.  Time course: ~30 min after Imm, given Epi.  No hx of egg allergy.				Y					Y	01/08/2008	01/08/2008	0	None	PVT	PUB	PPD test, Sanofi Pasteur, C2679AC, ID left forearm, one previous dose	URI	Obesity; seasonal allergies; left axillary hidradenitis supporativa			1						3	Chest discomfort; Eye pruritus; Swelling face; Throat irritation; Urticaria; Wheezing; Chest discomfort; Eye pruritus; Swelling face; Throat irritation; Urticaria; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500479P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB218AA~1~IM~LA~HEP A (HAVRIX)~2|VARCEL~MERCK & CO. INC.~1578U~2~SC~RA~VARICELLA (VARIVAX)~2|FLUN3~MEDIMMUNE VACCINES, INC.~500479P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB218AA~1~IM~LA~HEP A (HAVRIX)~3|VARCEL~MERCK & CO. INC.~1578U~2~SC~RA~VARICELLA (VARIVAX)~3	USA	Emergency room visit	Influenza
0299915	01/29/2008	NY	57.0	57		F	01/24/2008	Pt states approx 6-8 hrs after receiving flu vaccine, noted fever (not measured), headache, chills, muscle spasms and vomiting - all lasting approximately 4 hrs and then resolved.									Y	11/15/2007	11/15/2007	0	None	OTH	PVT	Unknown	Denies	NKDA - Depression			1						2	Chills; Headache; Muscle spasms; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2529AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0303818	01/29/2008	MD	35.0	35		F	01/29/2008	UPON TAKING THE FLU VACCINE, I BECAME ILL, BECAME HOARSE, DIZZY AND WEAK, EXPERIENCED A FEVER AND CHILLS.  MY THROAT HURT-I COUGHED FOR SEVERAL DAYS, MY HEAD HURT, MY BODY ACHED AND I WAS UNABLE TO GET A GOOD NIGHT'S REST.  ULTIMATELY I CAME TO MEDICAL AND WAS GIVEN SEVERAL PRESCRIPTIONS AND WAS 24 SICK-IN-QUARTERS.				Y					Y	01/22/2008	01/22/2008	0		MIL	UNK	CALCIUM CALTRATE, LOESTRIN 1.5E	NONE	ALLERGIC TO CARPET FIBERS	FATHER~Influenza (Seasonal) (no brand name)~~0.00~Patient		1						1	Asthenia; Chills; Cough; Dizziness; Dysphonia; Headache; Insomnia; Malaise; Pain; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~UNK~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0303822	01/29/2008	MI	11.0	11		F	01/29/2008	5 minutes following vaccine administration, patient began feeling funny she walked to the waiting room where she sat down and the room got blurry and then my hearing went out. Patient was unresponsive x 5-10 seconds. She was breathing during this episode. When she woke, she was diaphoretic and pale. We moved her to an exam room and laid her down. After 15 minutes, we attemped to sit her up, where she became pale and diaphoretic again. We then laid her down and attempted to get her up two more times where the same episode occurred again. We kept her in the clinic for 1 1/2 hours for observation and eventually wheeled her to the car. Mom was instructed to keep observing her and bring her to the ER if necessary. Mom reports today she is still a little shaky, but she is doing okay.									Y	01/28/2008	01/29/2008	1		UNK	UNK		Green yellow nasal discharge, cough occasionally, malaise	NKDA			1						1	Deafness transitory; Feeling abnormal; Hyperhidrosis; Pallor; Unresponsive to stimuli; Vision blurred	FLU3~SANOFI PASTEUR~U2465AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB218BA~1~IM~RL~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~1287U~2~IM~LL~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2406AA~1~IM~RL~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~AC52B019AA~1~IM~LL~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1507U~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0303823	01/29/2008	GA	54.0	54		F	01/29/2008	Patient presented the next day with cellulitis at injection site and fever of 100.0.									U	01/28/2008	01/28/2008	0	n/a	UNK	UNK	Lisinopril 10mg qd	none	asthma, hypertension, allergic to shellfish and penicillin			1						1	Injection site cellulitis; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80962~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0990U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0303825	01/29/2008	FL	68.0	68		F	01/29/2008	She recieved a flu shot 10/25/7 in my office. She has reported constant pain in the arm originating in the area of the injection since.  She saysd that it was very bad for the first 2 months but that it is getting better.  She felt that the area under her arm was also swollen (she thought from lymphnodes) and that the pain starts inher deltoid and it is piercing.  She can have pain into her neck and she has some decrease range of motion in the shoulder now. She is very certain that this started after her flu shot.									N	10/25/2007	10/25/2007	0	none	PVT	PVT	LYRICA, ALEVE, LISINOPRIL, NEXIUM, DIAZEPAM	NONE	NOROXIN ALLERGY . HTN, FIBROMYALGIA, LICHEN SCLEROSIS, VITAMIN D DEFICIENCY, GERD, MUSCLE CRAMPS			1						1	Injection site pain; Joint range of motion decreased; Neck pain; Oedema peripheral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLL042AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0303827	01/29/2008	LA	0.5	0	.5	M	01/23/2008	Fever. Hypoglycemia-Hospitalized with IVF- D10. 1/31/2008 MR received for DOS 1/16-22/2008 with chief complaint of Fever (no D/C DX on D/C Summary). Pt had apparently had some blood sugars below 80 at home 2' to fever and was admitted for supportive care.  Txd with D10 IV.				Y	Y	6	Y		Y	01/16/2008	01/16/2008	0	Labs and Diagnostics: Initial CBC with WBCs 13.7 up to 21.1 on 1/18/08. CMP benign, Blood sugar 67 on admission and remained normal or above throughout admission. Blood cx (-), Stool cx (-), throat cx (-).	PVT	UNK	Carnitine	None	MCAD. PMH: Medium-chain Acyl Dehydrogenase Deficiency, premie-10weeks in NICU, recent C-diff infection. NKDA.	Fever~Vaccine not specified (no brand name)~UN~0.00~In Patient|Fever~Vaccine not specified (no brand name)~UN~0.00~In Sibling		1						1	Hypoglycaemia; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B132CA~2~UN~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2477AA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0497U~2~UN~RL~HIB (PEDVAXHIB)~1|PPV~MERCK & CO. INC.~1035F~1~UN~RL~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0303830	01/29/2008	NC	1.52	1	.5	F	01/29/2008	Patient was given a varicella on 1-2-08. Patient came in on 1-18-08 with complaint of spot on arm. Patient diagnosed with local reaction due to Varicella vaccine.									Y	01/02/2008	01/18/2008	16	N/A	UNK	UNK	N/A	N/A	N/A			1						1	Local reaction; Skin lesion	DTAP~SANOFI PASTEUR~U2290AA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2508AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0303832	01/29/2008	TX	49.0	49		F	01/29/2008	Immediately following my flu shot, my entire arm hurt from shoulder down to tips of fingers. It was so painful that I had to go back to the nurse that administered it for help. She was already gone but another nurse advised me to put ice on it and take Acetaminophen (Tylenol), but Ibuprofen since Ibuprofen was found to weaken the serum. I took 800 mg. of Tylenol, but it did not help. After an hour, it still hurt so much that I had to go to our EMS office (in my bldg.) and there I found an RN who gave me an ice pack. I held it on the spot where the shot was given until I had to head home. My arm was painful for that entire day. I then decided to take Ibuprofen which I took 800 mg. That finally relieved my arm pain, until it wore off, then I took another 800 mg., which finally stopped it.									Y	10/31/2007	10/31/2007	0		UNK	UNK	Tylenol	None	Regular Allergy Shot			1						1	Immediate post-injection reaction; Injection site pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0303851	01/29/2008	CO	1.6	1	.6	M	01/28/2008	Pt had an allergic reaction hives on his face, swollen face. Gave him Benadryl. He had chicken noodle soup #3 approximately 3:00 or 3:30 that day.				Y					Y	01/14/2008	01/14/2008	0		UNK	UNK	Genotropin; Axid; Motrin; Thyroid med	None	Prader Willi			1						1	Hypersensitivity; Swelling face; Urticaria	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B129AA~UNK~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2488AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF215AA~UNK~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B97283B~UNK~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0303855	01/29/2008	SC	9.0	9		F	01/25/2008	Parent called on 01-23-08 at 10:10am.  Area around injection red & painful & warm to touch.  Reaction started off as a size of a quarter and spread further.									Y	01/21/2008	01/23/2008	2		PVT	UNK		None	Diabetes			1						1	Injection site erythema; Injection site pain; Injection site reaction; Injection site warmth	FLU3~SANOFI PASTEUR~U245~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1107U~UNK~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0303861	01/29/2008	MA	37.0	37		F	01/21/2008	Prolonged muscle soreness at injection site. From stabbing pain to ache. Not as painful as the first 2 mos after shot. Now periodic soreness at site. Aches.									N	10/10/2007	10/10/2007	0	None taken. Doctor initially prescribed Motrin.	MIL	OTH	Claritin; Flonase; Fioricette; Zomig	None	Allergies, Migraines			1						1	Injection site pain; Myalgia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0303862	01/29/2008	OH	45.0	45		F	01/17/2008	On 1/16/08, patient phoned office to report some redness and tenderness of left arm.  On 1/17/08, client reported to myself that left upper arm where she received pneumonia and flu was the size of a baseball in redness, very warm, painful to touch.									U	01/15/2008	01/16/2008	1	Unknown	PUB	PUB	Glucophage	None	Diabetes			1						1	Erythema; Feeling hot; Pain in extremity; Tenderness	FLU3~SANOFI PASTEUR~U2467AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0554U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0303863	01/29/2008	MI	1.0	0	1	M	01/23/2008	Multiple spots on back, neck, trunk, arms and legs with blisters.										01/01/2008	01/22/2008	21	None	PVT	PUB		Cough, wheeze				1						1	Blister; Skin lesion	FLU3~SANOFI PASTEUR~UT2474BA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB171AA~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1307U~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1507U~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0303865	01/29/2008	NY	75.0	75		F	01/21/2008	Nurse hit nerve when shot given - excruciating pain - 1/21/08. Almost cured. Cough 15 min after - lungs were wheezing. Called doctor and then called again in a couple of days. Respond 1/2/08! Nurseline a fantastic help. Empire. dose second to flu.									Y	12/11/2007	12/12/2007	1	None	PVT	OTH		None	RLS			1						1	Cough; Neuralgia; Wheezing	FLU3~SANOFI PASTEUR~U2476HA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0303867	01/29/2008	MI	9.0	9		F	01/23/2008	Large local reaction Varicella #2 Motrin, ice prn									U	01/21/2008	01/21/2008	0		PVT	PVT		None				1						1	Local reaction	FLU3~SANOFI PASTEUR~U2451AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1685U~2~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0303870	01/29/2008	NY	1.2	1	.2	M	01/25/2008	Had hives 24 hours after receiving flu vaccine.									Y	01/23/2008	01/24/2008	1	None	PVT	PVT	None	Cold symptoms	None			1						1	Urticaria	FLU3~SANOFI PASTEUR~UT2474BA~2~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0303871	01/29/2008	FL	12.0	12		F	01/23/2008	Pt received 2nd Gardasil; Tdap, Hep A on 3/29/07 and 3rd HPV on 1/21/08, 2nd Hep A, and flu vaccine. Pt had syncope spell in office after vaccines given. On 1/21/08 - went to dance class x 3 hours after left office. Pt has not had dizzy spells and sore throat since 1/21/08.									U	01/21/2008	01/21/2008	0	None	PVT	PVT	Ibuprofen		None			1						1	Syncope	FLU3~SANOFI PASTEUR~U2479AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB200BA~2~UN~LA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~1448U~7+~UN~RA~HPV (GARDASIL)~1	USA		Influenza
0303873	01/29/2008	OH	7.0	7		F	01/21/2008	Influenza symptoms (cough, fever) with positive nasopharyngeal test for influenza despite influenza vaccine (inadequate total # of immunizations).				Y					N	11/21/2007	01/16/2008	56	NP swab for influenza Ag	PUB	PUB	None	None	None	flu~Influenza (Seasonal) (no brand name)~4~2.00~In Sibling|flu~Influenza (Seasonal) (no brand name)~2~9.00~In Sibling		1						1	Cough; Influenza; Influenza serology positive; Pyrexia	FLU3~SANOFI PASTEUR~U2527AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0303874	01/29/2008	OH	2.0	2	.4	M		Had influenza symptoms (fever, cough) and positive NP swab for influenza despite adequate immunization.  1/6/06, 2/6/06, 12/5/06, 11/21/07.				Y						11/21/2007	01/18/2008	58	NP swab for influenza Ag	PUB	PUB		URI, intermittent abdomen pain				1						1	Cough; Influenza like illness; Influenza serology positive; Pyrexia; Virus culture positive	FLU3~SANOFI PASTEUR~UT2477FA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0303877	01/29/2008	MI	11.0	11		M	01/24/2008	Approximately 24h after vaccination the site was noted to be raised, red, hot and tender to touch about 2 diameter. By the following morning the dark red area encompassed almost the entire upper arm. The child exhibited no systemic sxs. As of today the area is about 3 diameter, light pink, tender but not hot.									Y	01/18/2008	01/19/2008	1	None	PVT	PVT	None	None	None			1						1	Erythema; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Oedema peripheral	FLU3~SANOFI PASTEUR~U2529AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1565V~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0303894	01/29/2008	WA	55.0	55		F	01/18/2008	None Stated										11/15/2007	11/15/2007	0		OTH	PUB		None	Sinus allergies			1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78994~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0303899	01/29/2008	NC	22.0	22		F	01/24/2008	Developed facial warmth, then another person noticed blotches on her face and arms.  Then she felt itching.									Y	01/24/2008			None	OTH	OTH	Prenatal vitamins	None	None			1						1	Pruritus; Rash; Rash macular; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80822~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0303900	01/29/2008	NC	76.0	76		M	01/29/2008	3-4 days after shot - pt noticed a pimple-like mark over area - then the are expanded to a circular, quarter-sized red-raw area that had tiny blisters on it.  Pt has seen 4 doctors and the 5th is scheduled for today - out of 5 MDs - 2 are specialists.				Y					N	10/23/2007	10/26/2007	3	Skin lesion, left upper arm, punch biopsy: subacute psoriasiform dermatitis with superficial perivascular chronic inflammation, negative for viral cytopathic effect or malignancy.  The differential diagnosis includes allergic contact dermatitis, dyshidrotic dermatitis, drug reaction, lichen simplex chronicus, and seborrheic dermatitis.	OTH	PVT	Lisinopril 10 mg, 1 tablet daily; Januvia 100 mg, 1 daily; metformin 1000 mg, 2 tablets daily; aspirin 81 mg, 1 daily; multivitamin 1 daily; Lumigan, 1 drop in each eye nightly; Levemir insulin, 25 units daily-PM; Digoxin .25 mg, 1 tablet S	None	Diabetes; pace-maker 9/20/07; macular degeneration			1						1	Biopsy skin; Blister; Dermatitis psoriasiform; Erythema; Perivascular dermatitis	FLU3~SANOFI PASTEUR~U2529AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0303901	01/29/2008	MI	17.0	17		M	01/24/2008	Mother reports her son had headache at bed time on 1/23/08 and awoke with headache. Came home from school at lunch time feeling tired, had headache had full body rash that began to itch in afternoon mom treating with Tylenol and bedrest.									U	01/08/2008	01/23/2008	15	None	PUB	PUB						1						1	Fatigue; Headache; Rash generalised; Rash pruritic	FLU3~SANOFI PASTEUR~U2476GA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB171AA~1~UN~LA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2418AA~1~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~1506U~1~UN~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0304086	01/29/2008	WI	53.0	53		M	01/24/2008	Right and front tooth pain and sensitivity to hot and cold.									U	12/26/2007	12/29/2007	3		PUB	OTH			sulfa			1						1	Toothache	FLU3~SANOFI PASTEUR~U2457EA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|JEV~SANOFI PASTEUR~EJU228A~UNK~UN~RA~JAPANESE ENCEPHALITIS (JE-VAX)~1|RAB~SANOFI PASTEUR~A0209~UNK~UN~RA~RABIES (IMOVAX)~1	USA		Influenza
0304177	01/29/2008	LA				F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of shortness of breath in a female subject aged between 40 and 49 years old who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  On 5 October 2007 at 16:00 the subject received 1st dose of Flulaval (.05 ml, unknown).  Within one hour after vaccination with Flulaval, on 05 October 2007, the subject experienced shortness of breath, tongue numbness and injection site tenderness.  The subject was seen in the emergency room but was not admitted to the hospital.  The reporter did not believe that the patient had received any previous influenza vaccinations.  The reporter also noted that she considered this to be a pharmaceutical product complaint.  At the time of reporting the events were improved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.				Y					N	10/05/2007	10/05/2007	0	Unknown	PVT	PVT		Unknown			A0687585A	1						1	Dyspnoea; Hypoaesthesia oral; Injection site pain; Pharmaceutical product complaint	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA037AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0304178	01/29/2008	DE	48.0	48		F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of malaise in a 48-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline) for prophylaxis. The subject had received influenza vaccine in previous years with no subsequent adverse events and also had no adverse events following receipt of other prior vaccinations. The subject received no concurrent vaccinations or medications on 2 October 2007. On 2 October 2007 the subject received unspecified dose of Flulaval ( .5 ml, unknown, left arm). On the evening of 4 October 2007. 2 days after vaccination with Flulaval, the subject experienced malaise, fatigue, myalgia and body feeling warm. The subject was seen by her personal physician who wrote an order that  she was sick on 03 October 2007 and 04 October 2007 and could return to work on 05 October 2007. At the time of reporting the events were resolved. Follow-up information received on 24 October 2007 indicated that the events actually began on the same day of Flulaval administration. The time to onset was not specified. The events completely resolved by 04 October 2007. In the reporter's opinion, the events were possibly related to treatment with Flulaval. The subject saw her primary care physician and was given a prescription, but it was felt that the symptoms may have been related to the vaccine.				Y					Y	10/02/2007	10/02/2007	0	UNK	OTH	PVT		Unknown	It was reported in follow-up that the subject has not experienced any adverse events following previous vaccinations.		A0687613A	1						1	Activities of daily living impaired; Fatigue; Malaise; Myalgia; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA035AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0304179	01/29/2008	LA				F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of injection site soreness in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 5 October 2007 the subject received unspecified dose of Flulaval (.5 ml, unknown, unknown arm).  On 5 October 2007, less than one day after vaccination with Flulaval, the subject experienced injection site soreness that was considered to be extreme.  The reporter also noted that the arms continued to be tender.  Pharmaceutical product complaint was also identified.  It was unknown if the subjects had previously received any influenza injections.  Also any previous reactions following vaccinations are also unknown.  At the time of reporting the events were improved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.  The reporter noted that this occurred in six patients.									N	10/05/2007	10/05/2007	0	UNK	PVT	PVT		Unknown	The healthcare professional reported that 6 other subjects experienced injection site soreness following receipt of Flulaval.  Please see cases A0687733A, A0687732A, A0687734A, A0687735A and A0687736A.		A0687720A	1						1	Injection site pain; Pharmaceutical product complaint; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA037AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304180	01/29/2008	LA	29.0	29		F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of injection site soreness in a 29 year old female who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  On 5 October 2007 the subject received unspecified dose of Flulaval at 0.5 ml in an unknown arm.  On 5 October 2007, the same day of vaccination with Flulaval, the subject experienced injection site soreness that was considered to be extreme.  The reporter also noted that the arm continued to be tender.  Pharmaceutical product complaint was also identified.  These events resolved by 08 October 2007 and were not considered to be related to treatment with Flulaval.  On follow-up, swollen arm an stiffness of the arm lasting two days was reported.  Onset of these events was not specified.  The reporter noted that this occurred in six patients.									Y	10/05/2007	10/05/2007	0	Unknown	PVT	PVT		Unknown	The subject received an unknown flu vaccine in the past.  The subject has no history of alcohol and tobacco use.  The healthcare professional reported that 6 other subjects experienced injection site soreness following receipt of Flulaval.  Please see cases A0687720A, A0687733A, A0687734A, A0687735A and A0687736A.		A0687732A	1						1	Injection site pain; Musculoskeletal stiffness; Oedema peripheral; Pharmaceutical product complaint	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA037AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304181	01/29/2008	LA				F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of injection site soreness in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 5 October 2007 the subject received unspecified dose of Flulaval (.5 ml, unknown, unknown arm).  On 5 October 2007, less than one day after vaccination with Flulaval, the subject experienced injection site soreness that was considered to be extreme.  The reporter also noted that the arms continued to be tender.  Pharmaceutical product complaint was also identified.  It was unknown if the subjects had previously received any influenza injections.  Also any previous reactions following vaccinations are also unknown.  At the time of reporting the events were improved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.  The reporter noted that this occurred in six patients.									N	10/05/2007	10/05/2007	0	UNK	PVT	PVT		Unknown	The healthcare professional reported that 6 other subjects experienced injection site soreness following receipt of Flulaval.  Please see cases A0687720A, A0687732A, A0687733A, A0687735A and A0687736A.		A0687734A	1						1	Injection site pain; Pharmaceutical product complaint; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA037AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304182	01/29/2008	LA				F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of injection site soreness in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 5 October 2007 the subject received unspecified dose of Flulaval (.5 ml, unknown, unknown arm).  On 5 October 2007, less than one day after vaccination with Flulaval, the subject experienced injection site soreness that was considered to be extreme.  The reporter also noted that the arms continued to be tender.  Pharmaceutical product complaint was also identified.  It was unknown if the subjects had previously received influenza injections.  Also any previous reactions following vaccinations was also unknown.  At the time of reporting the events were improved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.  The reporter noted that this occurred in six patients.									N	10/05/2007	10/05/2007	0	UNK	PVT	PVT		Unknown	The healthcare professional reported that 6 other subjects experienced injection site soreness following receipt of Flulaval.  Please see cases A0687720A, A0687732A, A0687734A, A0687733A and A0687736A.		A0687735A	1						1	Injection site pain; Pharmaceutical product complaint; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA037AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304183	01/29/2008	LA				F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of injection site soreness in a female subject of unspecified age who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  On 5 October 2007 the subject received unspecified dose of Flulaval (.5 ml, unknown, unknown arm).  On 5 October 2007, less than one day after vaccination with Flulaval, the subject experienced injection site soreness that was considered to be extreme.  The reporter also noted that the arms continued to be tender.  Pharmaceutical product complaint was also identified.  It was unknown if the subjects had previously received any influenza injections.  Also any previous reactions following vaccinations was also unknown.  At the time of reporting the events were improved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.  The reporter noted that this occurred in six patients.									N	10/05/2007	10/05/2007	0	Unknown	PVT	PVT		Unknown	The healthcare professional reported that 6 other subjects experienced injection site soreness following receipt of Flulaval.  Please see cases A0687720A, A0687732A, A0687734A, A0687735A and A0687733A.		A0687736A	1						1	Injection site pain; Pharmaceutical product complaint	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA037AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304184	01/29/2008	AL				U	01/16/2008	This case was reported by a healthcare professional and described the occurrence of an allergic reaction in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 10 October 2007 the subject received unspecified dose of Flulaval at 0.5 ml.  On 10 October 2007, at an unspecified time after vaccination with Flulaval, the subject experienced a severe allergic reaction.  At the time of reporting the outcome of the event was unspecified.  No further details were reported.									U	10/10/2007	10/10/2007	0	UNK	PVT	OTH		Unknown			A0687760A	1						1	Hypersensitivity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304185	01/29/2008					U	01/16/2008	This case was reported by a vaccine distributor and described the occurrence of welt form on the injection site in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline) for Prophylaxis. On an unspecified date the subject received unspecified dose of Flulaval (unknown). At an unspecified time after vaccination with Flulaval, the subject developed a welt at the injection site. The welt was about two inches across, and looked very similar to a bug bite. At the time of reporting the outcome of the event was unspecified.									U				UNK	OTH	OTH		Unknown			A068776BA	1						1	Injection site urticaria; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304186	01/29/2008	DE	31.0	31		M	01/16/2008	This case was reported by a healthcare professional and described the occurrence of body feeling warm in a 31-year-old male subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 4 October 2007 the subject received 1st dose of Flulaval at 0.5 ml in the left arm.  In the evening of 4 October 2007, less than one day after vaccination with Flulaval, the subject experienced body feeling warm, sweating and joint pain.  On 5 October 2007, the events were resolved.  The healthcare professional considered the events were possibly related to vaccination with Flulaval.  Follow-up was received from the healthcare professional.  The subject had no relevant medical history.									Y	10/04/2007	10/04/2007	0	UNK	OTH	OTH		Unknown	The subject has never previously had a flu vaccine and had no significant medical history.		A0688099A	1						1	Arthralgia; Feeling hot; Hyperhidrosis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA035AA~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304187	01/29/2008	LA				U	01/16/2008	This case was reported by a healthcare professional (distributor) and described the occurrence of allergic reaction in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received unspecified dose of Flulaval (unknown). At an unspecified time after vaccination with Flulaval, the subject experienced allergic reaction, shortness of breath body pain and tongue numbness. The subject required medical attention in the emergency room. At the time of reporting the outcome of the events was unspecified. The reporter did not know if the patient had previously received any influenza vaccinations. It was also unknown if the subject had any adverse events following previous vaccinations.				Y					U				UNK	OTH	OTH		Unknown			A0688290A	1						1	Dyspnoea; Hypersensitivity; Hypoaesthesia oral; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLA058AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0304188	01/29/2008	LA				U	01/16/2008	This case was reported by a healthcare professional (distributor) and described the occurrence of injection site tenderness in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On an unspecified date the subject received unspecified dose of Flulaval (unknown).  At an unspecified time after vaccination with Flulaval, the subject experienced injection site tenderness.  At the time of reporting the outcome of the event was unspecified.				Y					U				UNK	OTH	OTH		Unknown	The reporter stated that this occurred in one other subject (A0688303A).		A0688302A	1						1	Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA058AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0304189	01/29/2008	LA				U	01/16/2008	This case was reported by a healthcare professional (distributor) and described the occurrence of injection site tenderness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received unspecified dose of Flulaval (unknown). At an unspecified time after vaccination with Flulaval, the subject experienced injection site tenderness. At the time of reporting the outcome of the event was unspecified. The reporter did not know if the patient had previously received any influenza vaccinations. It was also unknown if the subject had any adverse events following previous vaccinations.				Y					U				UNK	OTH	OTH		Unknown	The reporter stated that this occurred in one other subject (A0688302A).		A0688303A	1						1	Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA058AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0304190	01/29/2008	WY	24.0	24		F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of the throat feeling tight in a 24-year-old female subject who was vaccinated with influenza vaccine trivalent (Flulaval, GlaxoSmithKline) for prophylaxis. Concurrent medications included unknown (Depo), Sertraline hydrochloride (Zoloft), Guaiphenesin (Mucinex) and Clartin-D (Claritin D). On 11 October 2007 at 15:30 the subject received unspecified dose of Flulaval, the subject expereinced a slight sensation of  throat tightness and swelling. The events were resolved by 15 October 2007. Causality was not known.									Y	10/11/2007	10/12/2007	1	UNK	PVT	PVT	Sertraline hydrochloride; Guaiphensein; Claritn-D; (Loratadine + Pseudoephedrine HCl)	Unknown	The subject has a history of allergy to penicillin, Cipro and Neosporin and no history of adverse events following previous vaccinations. The reporter was not sure about possible reactions to previous flu vaccines.		A0688320A	1						1	Pharyngeal oedema; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA039AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304191	01/29/2008	AL				F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of the use of expired vaccine in an adult female subject who was vaccinated with influenza trivalent (Flulaval, GlaxoSmithKline), influenza virus vaccine (flu vaccine) for prophylaxis. Concurrent medications included Diphenydramine hydrochloride (Benadryl). On either 15 October 2007 or 16 October 2007, the subject received unspecified dose of Flulaval at 0.5 ml. Following vaccination with Flulaval it was noted that the drug administered was last years vaccine which was expired. No adverse events were reported. It was also noted at the time of reporting that the subject received flu vaccine in the past (unknown manufacturer) and experienced shortness of breath and rash. The reporter stated that she had no further details on this past experience.									U				UNK	OTH	OTH	Diphenydramine HCl	Unknown	History of mild allergy to egg, therefore, premedicated with Benadryl. The subject received flu vaccine in the past (unknown which brand) and experienced shortness of breath and rash (no further details were known).		A0689020A	1						1	Expired drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601611~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304192	01/29/2008	AL	40.0	40		F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of the use of expired vaccine in a 41 year old female subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  Concurrent medications included Lexapro.  On 15 October 2007 the subject received unspecified dose of Flulaval at 0.5 ml.  On 16 October 2007, 1 day after vaccination with Flulaval, the subject experienced injection site redness described as localized erythema.  An unknown amount of time after vaccination with Flulaval, it was noted that the drug used was last year's vaccine and was expired.  At the time of reporting the outcome of the events was unspecified.  The healthcare professional considered the event of injection site redness to be probably related to vaccination with Flulaval.									U	10/15/2007	10/16/2007	1	UNK	OTH	OTH	Lexapro	Unknown			A0689050A	1						1	Erythema; Expired drug administered; Injection site erythema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2F601611~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304193	01/29/2008	SC				F	01/16/2008	This case was reported by a pharmacist and described the occurrence of swelling injection site in an adult female subject who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  On 16 October 2007 the subject received 1st dose of Flulaval (.5 ml, unknown).  On 16 October 2007, less than one day after vaccination with Flulaval, the subject experienced swelling injection site and injection site warmth.  The subject questioned the possibility of a wrong route of administration.  She believed that she was vaccinated subcutaneously due to the swelling and heat at the injection site.  At the time of reporting the outcome of the events were unspecified.									U	10/16/2007	10/16/2007	0	Unknown	PVT	OTH		Unknown			A0689258A	1						1	Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA030AA~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304194	01/29/2008	CA	31.0	31		M	01/16/2008	This case was reported by a healthcare professional and described the occurrence of neck tingling in a male subject aged between 30 and 39 years old who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  The subject received no vaccines other than Flulaval on 17 October 2007.  On 17 October 2007 at 11:30 the subject received unspecified dose of Flulaval (0.5 mL; unknown, left arm).  On 17 October 2007 at 12:35 p.m., within 65 minutes of vaccination with Flulaval, the subject returned to report a strange sensation described as tingling of the neck on the left side, and a sensation of warmth running down the left leg.  The site of vaccination reportedly looked normal.  At the time of reporting the events were unresolved.  The reporting health care professional is employed by an agency that provides influenza vaccines to clients at the clients' sites; the vaccine that is the subject of this report was administered at an attorney's office.  Follow-up was received by the healthcare professional on 02 November 2007.  At the time of reporting, the subject was 31 years of age.  The subject had previously received influenza vaccines and had not experienced any reactions following prior influenza vaccinations.  The subject had no history of adverse events following previous vaccinations.  Medical history included a possible shellfish allergy.  The healthcare professional reported that, after considerable interviewing, the subject noted that he has experienced these same sensations (tingling of the neck on the left side, and a sensation of warmth running down the left leg) in the past after eating shellfish.  The events resolved on 17 October 2007.  The healthcare professional considered the events to be related to vaccination with Flulaval.									Y	10/17/2007	10/17/2007	0	Unknown	OTH	PVT	Unknown	Unknown	Shellfish allergy.  The subject's concurrent medical conditions, and concurrent medications if any were unspecified.  The subject had no known allergies and no allergies to thimerisol or eggs.  The subject had previously received influenza vaccines and had not experienced any reactions following prior influenza vaccinations.  The subject had no history of adverse events following previous vaccinations.  The subject noted after considerable interviewing that he has experienced these same sensations (tingling of the neck on the left side, and a sensation of warmth running down the left leg) in the past after eating shellfish.		A0689367A	1						1	Feeling abnormal; Feeling hot; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLA039AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304195	01/29/2008	SC	42.0			F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of injection site redness in a 42-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 17 October 2007, the subject received a 0.5 ml dose of Flulaval below the deltoid in an unspecified arm.  On 18 October 2007, approximately one day after vaccination with Flulaval, the subject experienced injection site redness.  At the time of reporting the outcome of the event was unspecified.									U	10/17/2007	10/18/2007	1	UNK	PVT	PVT		Unknown	The subject had a history of previous influenza vaccinations.  The subject's medical history, concomitant medications, and history of adverse events following previous vaccinations were not reported.  A0689640A was one of two cases of injection site redness reported by the same healthcare professional.  Please reference report A0689650A for further information.		A0689640A	1						1	Injection site erythema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~2008JL~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304196	01/29/2008					U	01/16/2008	This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  On an unspecified date the subject received an unspecified dose of Flulaval (unknown).  At an unspecified time after vaccination with Flulaval, the subject experienced injection site redness.  At the time of reporting the outcome of the event was unspecified.									U				Unknown	OTH	OTH		Unknown	A0689650A was one of two cases of injection site redness reported by the same healthcare professional.  Please reference report A068940 for further information.		A0689650A	1						1	Injection site erythema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304197	01/29/2008	NY	51.0	51		M	01/16/2008	This case was reported by a physician and described the occurrence of accidental exposure while preparing drug for administration in a 51-year-old male subject who was to receive Flulaval (GlaxoSmithKline) for prophylaxis.  The reporter is also the subject.  On 23 October 2007 at approximately 11:10 the subject was ready to have an unspecified dose of Flulaval administered.  The Flulaval was accidentally splattered into eye and he experienced accidental exposure to the Flulaval as the vaccine was getting ready to be administered.  He also experienced some burning of his right eye.  The subject washed out his eye with water and applied ophthalmic tear drops.  The subject will possibly seek medical attention with an ophthalmologist.  At the time of reporting the outcome of the events was unspecified.									U	10/23/2007	10/23/2007	0	UNK	PVT	OTH		Unknown	No relevant medical history.		A0690847A	1						1	Accidental exposure; Eye irritation	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304205	01/29/2008	MS	32.0	32		F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of injection site redness in a 32-year-old female subject who was vaccinated with Flulaval for prophylaxis. The healthcare professional is the subject. The subject reported that she had received influenza virus vaccine in previous years and experience transient low-grade fever and aches. Concurrent medications included Yaz. On 22 October 2007 the subject received unspecified dose of Flulaval (.5 ml, unknown, left arm). On 23 October 2007, within 24 hours after vaccination with Flulaval, the subject experienced injection site redness, injection site soreness, and injection site warmth. The subject was seen by a physician. The subject stated that she did not experience the fever and aches that she had experienced with previous influenza vaccinations. At the time of reporting the events were unresolved. The subject also reported a product complaint because she is concerned over the potential for a contaminated or defective product. The healthcare professional considered the events were probably related to vaccination with Flulaval.				Y					N	10/22/2007	10/23/2007	1	UNK	PVT	OTH	Yaz	Unknown			A0690861A	1						1	Injection site erythema; Injection site pain; Injection site warmth; Pharmaceutical product complaint	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA027AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0304211	01/29/2008	LA	50.0			M	01/16/2008	This case was reported by a healthcare professional and described the occurrence of injection site pain in a 50-year-old male subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 11 October 2007 the subject received 1st dose of Flulaval (.5 ml, unknown, right arm).  On 21 October 2007, 10 days after vaccination with Flulaval, the subject experienced injection site pain.  At the time of reporting the event was unresolved.									N	10/11/2007	10/21/2007	10	UNK	OTH	PVT		Unknown			A0690875A	1						1	Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA503AA~1~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304213	01/29/2008	MS	43.0			F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of a large, red ring around the injection site in a 43-year-old female subject who was vaccinated with Flulaval for prophylaxis. There were no concurrent medication. On 24 October 2007 at 14:05 the subject received unspecified dose of Flulaval at 0.5 ml in the left arm. on 24 October 2007, 1 hour after vaccination with Flulaval, the subject experienced a red ring at the injection site that was reportedly the size of a silver dollar. The following morning, on 25 October 2007, the subject developed a rash on the chest area. The subject experienced both a local and a systemic reaction to the vaccine. The subject was treated with Benadryl and Tylenol. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Flulaval.									N	10/24/2007	10/24/2007	0	UNK	PVT	PVT	No concurrent medication		It was reported that the subject has previously received flu shots and has not had any documented reactions to previous flu shots or other vaccinations.		A0691495A	1						1	Injection site erythema; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA075AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304214	01/29/2008	MS	34.0			F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of a large, raised knot at the injection site in a 34-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  There were no concurrent medications.  On 24 October 2007 at 14:00 the subject received unspecified dose of Flulaval at 0.5 ml in the left arm.  On 24 October 2007, 30 minutes after vaccination with Flulaval, the subject developed a large, raised knot (the size of a fist) at the injection site.  The injection site was also warm to the touch and red.  The subject was treated with Benadryl and Tylenol.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.									N	10/24/2007	10/24/2007	0	UNK	PVT	PVT	No concurrent medication	Unknown	It was reported that the subject had previously received flu shots and experienced muscle tenderness.  With other vaccinations (not specified), the subject has experienced mild redness.  The subject has no allergies.		A0691501A	1						1	Injection site erythema; Injection site mass; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA075AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304217	01/29/2008	MS	46.0			F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of red induration in a 46-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  There were no concurrent medications.  On 24 October 2007 at 14:15 the subject received unspecified dose of Flulaval at 0.5 ml in the left arm.  On 24 October 2007, immediately after vaccination with Flulaval, the subject experienced red induration and injection site hot to the touch.  The subject was treated with Tylenol.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.									N	10/24/2007	10/24/2007	0	UNK	PVT	PVT	No concurrent medication	Unknown	It was reported that the subject has previously received flu shots and has not had any documented reactions to previous flu shots or other vaccinations.		A0691502A	1						1	Erythema; Immediate post-injection reaction; Induration; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA075AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304219	01/29/2008	DC	46.0	46		F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of injection site redness in a 46-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  The subject's medical history included allergy to mites, allergy to molds, latex allergy, shellfish allergy and tetracycline allergy since approximately 1985.  The healthcare professional reported that the subject receives allergy injections which have caused injection site reactions in the past.  Concurrent medications included Claritin and allergy injections.  The administration site for the allergy injections was not provided.  No other immunizations were administered on 24 October 2007.  The subject received influenza virus vaccine in previous years, however, it was not reported whether adverse events occurred following receipt of prior influenza virus vaccinations.  On the morning of 24 October 2007 the subject received 1st dose of Flulaval (.5 ml, intramuscular, unknown deltoid).  In October 2007, on or after 24 October 2007 and on or before 26 October 2007, less than one week after vaccination with Flulaval, the subject experienced injection site redness, warmness to touch at injection site and injection site discomfort.  The reporter stated that the subject refused treatment for this reaction.  At the time of reporting the events were unresolved.  Follow-up received on 27 November 2007 via the nurse.  She reported that on 26 October 2007, two days following vaccination with Flulaval, the subject experienced injection site redness, warmness to touch at the injection site and injection site discomfort.  The events resolved after approximately one week around 01 or 02 November 2007.  The reporter considered that the events were not serious.  The reporter considered that the events were related to the use of Flulaval.									Y	10/24/2007	10/26/2007	2	UNK	UNK	UNK	loratadine; allergy medication	Unknown	ALLERGY MITES, ALLERGY TO MOLDS, LATEX ALLERGY, LOCAL REACTION TO ALLERGY INJECTION, SHELLFISH ALLERGY, TETRACYCLINE ALLERGY.  History: It was noted that the onset date for allergy to mites, allergy to molds, latex allergy, local reaction to allergy injection, shellfish allergy, and tetracycline allergy was approximately 1985.		A0691533A	1						1	Injection site discomfort; Injection site erythema; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA034AA~1~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304221	01/29/2008	MA	52.0	52		F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of body pain in a 52-year-old female subject who was inadvertently exposed to Flulaval for prophylaxis. The reporter is the subject. The subject reported that she had no relevant medical history. The subject had been previously vaccinated with influenza virus vaccine and did not experience any adverse events. The subject also had no adverse events following receipt of prior immunizations. There was no concurrent medications. On the dates of 23 October 2007 through 30 October 2007, the subject, a nurse was accidentally exposed to Flulaval. The nurse reported that when administering the Flulaval, once she withdrew the syringe from the vial, the solution sprayed in the air. The Nurse states the solution went up her nose and she could taste and smell the solution 6-12 hours after she administered the vaccine. The subject also reported that, 6 to 12 hours after the accidental exposure to Flulaval, she experienced body ache, nasal congestion and fatigue. The subject administered the Flulaval to over 100 individuals. The reporter considered the events to be a product complaint. At the time of reporting the outcome of the events was unspecified.									U	10/01/2007	10/01/2007	0	UNK	PUB	OTH	No concurrent medication	Unknown	The subject reported that she had no relevant medical history.		A0692351A	1						1	Accidental exposure; Dysgeusia; Fatigue; Nasal congestion; Pain; Pharmaceutical product complaint	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AF11A050~UNK~IN~NS~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304222	01/29/2008	HI				F	01/16/2008	This case was reported by a pharmacist and described the occurrence of bilateral rash in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions include breast cancer.  On 10 October 2007 the subject received unspecified dose of Flulaval at 0.5 ml.  It was mentioned that the subject completed radiation (for the treatment of breast cancer) on 12 October 2007.  On 14 October 2007, 4 days after vaccination with Flulaval, the subject experienced bilateral rash. On 26 October 2007, the event was resolved.									Y	10/10/2007	10/14/2007	4	UNK	OTH	OTH		BREAST CANCER	The subject was receiving radiation treatment for breast cancer.		A0693982A	1						1	Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA026AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304224	01/29/2008	WA				U	01/16/2008	This case was reported by a healthcare professional and described the occurrence of a red circle around the injection site in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 30 October 2007 the subject received a one time dose of Flulaval at 0.5 ml in the left arm.  On 30 October 2007, at an unspecified time after vaccination with Flulaval, the subject experienced an injection site reaction.  The subject developed a 1.5 inch circular, red, hot injection site reaction.  At the time of reporting the outcome of the events was unspecified.									U	10/30/2007	10/30/2007	0	UNK	PUB	PUB		Unknown			A0693985A	1						1	Injection site erythema; Injection site reaction; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA026AA~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304299	01/29/2008	WA				U	01/16/2008	This case was reported by a healthcare professional and described the occurrence of a red circle around the injection site in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 31 October 2007 the subject received a one time dose of Flulaval at 0.5 ml in the left arm.  On 31 October 2007, at an unspecified time after vaccination with Flulaval, the subject experienced an injection site reaction.  The subject developed a 3 inch circular, red, hot injection site reaction.  At the time of reporting the events were unresolved.									N	10/31/2007	10/31/2007	0	UNK	PUB	PUB		Unknown			A0693995A	1						1	Injection site erythema; Injection site reaction; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA026AA~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304300	01/29/2008	WA	50.0			F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of a red circle around the injection site in a 50  year old female subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 30 October 2007 the subject received a one time dose of Flulaval in the left arm.  On 30 October 2007, at an unspecified time after vaccination with Flulaval, the subject experienced an injection site reaction.  The subject developed a 1.5 inch circular, red, hot injection site reaction.  At the time of reporting the events were unresolved.									N	10/30/2007	10/30/2007	0	UNK	PUB	PUB		Unknown			A0693996A	1						1	Injection site erythema; Injection site reaction; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA026AA~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304301	01/29/2008	IL				M	01/16/2008	This case was reported by a physician and described the occurrence of muscle soreness at injection site in an adult male subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  In October 2007 the subject received unspecified dose of Flulaval (.5 ml, unknown, left arm).  In October 2007, the same day after vaccination with Flulaval, the subject experienced muscle soreness at injection site.  One day after vaccination with Flulaval, the subject experienced tiredness and achiness.  The subject experienced muscle soreness at injection site, tiredness and pain for approximately one day after the vaccination.  The subject was treated with Advil.  At the time of reporting, the events were unresolved.									Y				UNK	OTH	OTH		Unknown	The subject reported having a flu vaccine for the last five years.  The subject had no adverse events following receipt of prior immunizations.		A0694009A	1						1	Fatigue; Injection site pain; Injection site reaction; Myalgia; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304302	01/29/2008	CA	37.0	37		F	01/16/2008	This case was reported by a pharmacist and described the occurrence of redness of eyes in a 37-year-old female subject who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  The subject had no relevant medical history.  There were no concurrent medications.  The subject received influenza virus vaccine in previous years with no subsequent adverse events and also had no adverse events following receipt of any prior immunizations.  On 2 November 2007 at 9:45 a.m., the subject received unspecified dose of Flulaval (.5 ml, unknown, left arm).  On 2 November 2007 at 11:45 a.m., 2 hours after vaccination with Flulaval, the subject stopped back by the pharmacy because she was experiencing problems following her vaccination, including redness of eyes, cough, chest tightness and white exudate in eyes.  The subject did say that the symptoms have not been getting worse.  At the time of reporting the events were unresolved.  The pharmacist considered the events were probably related to vaccination with Flulaval.  Follow-up was received on 27 November 2007 from the reporting pharmacist.  The onset of the adverse events was 2 November 2007, one hour after the receipt of Flulaval.  The events resolved on 04 November 2007.									Y	11/02/2007	11/02/2007	0	Unknown	OTH	PVT	No concurrent medications	Unknown	The subject had no relevant medical history.  The subject's race was reported as Armenian.		A0694039A	1						1	Chest discomfort; Cough; Eye discharge; Ocular hyperaemia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA031AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304303	01/29/2008					U	01/16/2008	This case was reported by a consumer and described the occurrence of allergic reaction in an elderly subject of unspecified gender who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of Flulaval (unknown).  At an unknown time after vaccination with Flulaval, the subject experienced allergic reaction.  At the time of reporting the outcome of the event was unspecified.									U				UNK	OTH	OTH		Unknown	The reporter stated that three additional subjects experienced allergic reactions after vaccination with Flulaval.  Please see A0695189A, A0695190A, and A0695191A.		A0694249A	1						1	Hypersensitivity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLA026AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304304	01/29/2008					U	01/16/2008	This case was reported by a consumer and described the occurrence of allergic reaction in an elderly subject of unspecified gender who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of Flulaval (unknown).  At an unknown time after vaccination with Flulaval, the subject experienced allergic reaction.  At the time of reporting the outcome of the event was unspecified.									U				UNK	OTH	OTH		Unknown	The reporter stated that three additional subjects experienced allergic reactions after vaccination with Flulaval.  Please see A0694249A, A0695190A, and A0695191A.		A0695189A	1						1	Hypersensitivity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLA026AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304305	01/29/2008					U	01/16/2008	This case was reported by a consumer and described the occurrence of allergic reaction in an elderly subject of unspecified gender who was vaccinated with Flulaval for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Flulaval (unknown). At an unknown time after vaccination with Flulaval, the subject experienced allergic reaction. At the time of reporting the outcome of the event was unspecified.									U				UNK	OTH	OTH		Unknown	The reporter stated that three additional subjects experienced allergic reactions after vaccination with Flulaval. Please see A0694249A, A0695189A, and A0695191A.		A0695190A	1						1	Hypersensitivity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLA026AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304306	01/29/2008					U	01/16/2008	This case was reported by a consumer and described the occurrence of allergic reaction in an elderly subject of unspecified gender who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of Flulaval (unknown).  At an unknown time after vaccination with Flulaval, the subject experienced allergic reaction.  At the time of reporting the outcome of the event was unspecified.									U				UNK	OTH	OTH		Unknown	The reporter stated that three additional subjects experienced allergic reactions after vaccination with Flulaval.  Please see A0694249A, A0695189A, and A0695190A.		A0695191A	1						1	Hypersensitivity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLA026AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304307	01/29/2008	NJ	59.0	59		F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of frozen shoulder in a 59-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  The subject's medical history included diabetes and hypothyroidism.  The subject's concurrent conditions and concurrent medications were not reported.  The subject had received influenza virus vaccine in previous years with no subsequent adverse events.  The subject received no other immunizations on the date of receipt of Flulaval.  On 26 October 2007 the subject received unspecified dose of Flulaval (unknown, left arm).  On 27 October 2007, 1 day after vaccination with Flulaval, the subject experienced frozen shoulder, injection site pain and injection site soreness.  The subject was seen by an orthopedic doctor.  The subject was treated with Cortizone shot and physical therapy.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.				Y					N	10/26/2007	10/27/2007	1	UNK	PVT	PVT		Unknown	DIABETES; HYPOTHYROIDISM.  The subject's concurrent conditions and concurrent medications were not reported.		A0695447A	1						1	Injection site pain; No reaction on previous exposure to drug; Periarthritis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA051AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0304308	01/29/2008	KS				F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of injection site reaction in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 2 November 2007 the subject received unspecified dose of Flulaval in an unknown arm.  Immediately after vaccination with Flulaval, the subject experienced an injection site reaction.  On 4 November 2007, the event was resolved.  Follow-up information was received on 11 December 2007 via a healthcare professional, who reported that the subject immediately developed a lump and redness at the injection site following vaccination of Flulaval.  The reporter stated that the events were resolved in two days with no further problems.									Y	11/02/2007	11/02/2007	0	UNK	PVT	PVT		Unknown	The subject's history of adverse events following previous vaccinations was unknown.  A0696121A was one of two cases reported by the same healthcare professional.  Please reference report A0696126A.		A0696121A	1						1	Injection site erythema; Injection site mass; Injection site reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA027AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304309	01/29/2008	KS				F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of injection site reaction in a female subject of unspecified age who was vaccinated with Flulaval for prophylaxis. On 2 November 2007 the subject received unspecified dose of Flulaval in an unknown arm. Immediately after vaccination with Flulaval, the subject experienced an injection site reaction. On 4 November 2007, the event was resolved. Follow-up information was received on 11 December 2007 via a healthcare professional, who reported that the subject immediately developed a lump and redness at the injection site following vaccination with Flulaval. The reporter stated that the events were resolved in two days with no further problems.									Y	11/02/2007	11/02/2007	0	UNK	PVT	PVT		Unknown	The subject's history of adverse events following previous vaccinations was not reported. A0696126A was one of two cases reported by the same healthcare professional. Please reference report A0696121A.		A0696126A	1						1	Immediate post-injection reaction; Injection site erythema; Injection site mass; Injection site reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA027AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304311	01/29/2008	CO	72.0	72		M	01/16/2008	This case was reported by a pharmacist and described the occurrence of leg pain in a 72-year-old male subject who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  The subject's medical history included arthritis, diabetes, high cholesterol and hypertension.  Concurrent medications included Caduet.  The subject received no other vaccinations on the date of receipt of Flulaval.  Information regarding receipt of previous immunization with Flulaval was not provided.  The subject had no adverse events following receipt of prior immunizations.  On 16 November 2007 at 2:21 p.m., the subject received unspecified dose of Flulaval (.5 ml, unknown, left arm).  On an unspecified date on or after 16 November 2007 and on or before 20 November 2007, less than one week after vaccination with Flulaval, the subject experienced left leg pain.  At the time of reporting the event was unresolved.  Follow-up information was received on 18 December 2007 via a pharmacist, who reported that the outcome of the event was unknown.									N	11/16/2007			Unknown	OTH	PVT	Caduet (Amlodipine besylate + Atorvastatin calcium)	Unknown	Arthritis; Diabetes; High Cholesterol; Hypertension		A0696131A	1						1	Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~U2453AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304312	01/29/2008	NC	15.0	15		F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of fatigue in a 15-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  No other vaccinations given on the same day as Flulaval.  No relevant medical history or concurrent medications.  On 24 November 2007 at 15:47 the subject inadvertently received unspecified dose of Flulaval (.5 ml, unknown, right arm) and experienced a vaccination error as she as supposed to received a pediatric vaccine.  On 01 December 2007, 7 days after vaccination with Flulaval, the subject experienced mild fatigue.  She was seen by a physician on 03 December 2007 because the fatigue persisted. No medications or treatment were prescribed during the visit.  Subject was told to follow up if her symptom changed.  At the time of reporting the fatigue was unresolved.  The healthcare professional considered the fatigue was probably related to vaccination with Flulaval.				Y					N	11/24/2007	11/24/2007	0	UNK	PUB	PVT	no concurrent medications	Unknown	No relevant medical history, no concurrent medications and no adverse events following previous vaccinations.		A0697393A	1						1	Fatigue; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA058AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0304314	01/29/2008	WV	27.0	27		F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of deltoid pain in an 27-year-old female subject who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  Concurrent medications included Ibuprofen (Advil), Paracetamol (Tylenol) and Cold medication.  Following previous influenza vaccinations (unknown manufacturer), the subject's arm felt tingly but it went away 4-5 hours after the shot was administered.  Subject also experienced minor soreness for a couple of days.  See GSK case A0698837A for details.  On 26 October 2007 the subject received 1st dose of Flulaval (.5 ml, left arm).  On 26 October 2007, within 2 hours after vaccination with Flulaval, the subject experienced pain to movement in deltoid.  That same day she also experienced pain in arm on lifting heavy objects and pain when moving arm above her or behind her.  The following day she experienced arm stiffness in the morning.  At an unspecified time during the week of 18 November 2007, she experienced a cold.  The subject did consult with a physician regarding the events.  At the time of reporting the arm stiffness, pain lifting heavy objects and pain when moving arm above or behind her had improved.  The pain in the deltoid area was unresolved.  The outcome of the cold was unspecified.  The facility received two lots of vaccine and they were not certain which lot number this Flulaval came from.  The two lot numbers are AFLLA0533AA and AFL1A0075AA.									U	10/26/2007	10/26/2007	0	Unknown	OTH	OTH	Ibuprofen; Paracetamol; Cold medication	Unknown	Relevant history: Following previous influenza vaccinations, the subject's arm felt tingly but it went away 4-5 hours after the shot was administered.  She also experienced minor soreness for a couple of days.  See GSK case A0698837A for details.		A0698460A	1						1	Injected limb mobility decreased; Musculoskeletal stiffness; Pain in extremity; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA053AA~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304315	01/29/2008	OK				U	01/16/2008	This case was reported by a physician to a vaccine distributor and described the occurrence of rash in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  The subject's medical history, concurrent conditions, and concurrent medications were not reported.  Information regarding previous immunization with influenza virus vaccine was not provided.  On an unspecified date on or before 14 November 2007, the subject received unspecified dose of Flulaval (unknown).  At an unspecified time after vaccination with Flulaval, the subject experienced rash.  At the time of reporting the outcome of the event was unspecified.				Y					U				UNK	OTH	OTH	concurrent medications were not reported	Unknown	The subject's medical history, concurrent conditions, and concurrent medications were not reported.  The vaccine distributor reported that one other subject experienced an adverse event following receipt of Flulaval.  Please see case A0694802A.		A0694812A	1						1	Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA039AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0304316	01/29/2008	OR	39.0			F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of injection site pain in an adult subject of unspecified gender who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  The subject's medical history, concurrent conditions, and concurrent medications were not reported.  No other vaccinations were administered on the date of Flulaval administration.  The subject had received influenza virus vaccine in previous years with no subsequent adverse events.  On an unspecified date the subject received unspecified dose of Flulaval (.5 ml, unknown, unknown arm).  At an unspecified time after vaccination with Flulaval, the subject experienced injection site pain and product complaint.  The subject returned to the clinic for further evaluation.  The healthcare professional considered the events were disabling.  The clinic used a 1 inch, 30 gauge needle to administer the vaccinations.  The office is very concerned about using additional doses of this vaccine and believe there is a quality issue associated with it.  The healthcare professional reported that the injection site pain lasted greater than two weeks.  The outcome of the events was unspecified.  Follow-up information received on 27 November 2007 indicated that the subject was a 39 year old female.  The event of left arm pain was documented and the date of the earliest sign or symptom onset was recorded as 17 October 2007.  The events were reportedly improved and considered by the reporter to be related to treatment with Flulaval.  The events were initially reported as disabling and on follow-up, indicated to not be disabling.  No other details were reported.				Y					N		10/17/2007		UNK	PVT	PVT		Unknown	The subject had received influenza virus vaccine in previous years with no subsequent adverse events.  The subject's medical history, concurrent conditions, and concurrent medications were not reported.  The healthcare professional reported that 2 other subjects experienced injection site pain following administration of Flulaval.  Please see cases A0691342A and A0691343A.		A0691341A	1						1	Injection site pain; Pain in extremity; Pharmaceutical product complaint	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA066AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0304317	01/29/2008	OR				U	01/16/2008	This case was reported by a healthcare professional and described the occurrence of injection site pain in an adult subject of unspecified gender who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  The subject's medical history, concurrent conditions, and concurrent medications were not reported.  No other vaccinations were administered on the date of Flulaval administration.  The subject had received Flulaval in previous years with no subsequent adverse events.  On an unspecified date the subject received unspecified dose of Flulaval (.5 ml, unknown, unknown arm).  At an unspecified time after vaccination with Flulaval, the subject experienced injection site pain and product complaint.  The subject returned to the clinic for further evaluation.  The healthcare professional considered the events were disabling.  The clinic used a 1 inch, 30 gauge needle to administer the vaccinations.  The office is very concerned about using additional doses of this vaccine and believe there is a quality issue associated with it.  The healthcare professional reported that the injection site pain lasted greater than two weeks and the outcome of the events was unspecified. Follow-up received on 22 January 2008 via the healthcare professional and it was reported that she was not aware of any other reactions at this time.				Y				Y	U				Unknown	PVT	PVT	Unknown	Unknown	The subject's medical history, concurrent conditions, and concurrent medications were not reported.  The healthcare professional reported that 2 other subjects experienced injection site pain following administration of Flulaval.  Please see cases A0691341A and A0691343A.		A0691342A	1						1	Injection site pain; Product quality issue	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA066AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Disabling	Influenza
0304318	01/29/2008	OR				U	01/16/2008	This case was reported by a healthcare professional and described the occurrence of injection site pain in an adult subject of unspecified gender who was vaccinated with influenza vaccine trivalent (Flulaval, GlaxoSmithKline) for prophylaxis. The subject's medical history. Concurrent conditions, and concurrent medications were not reported. No other vaccinations were administered on the date of Flulaval administration. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On an unspecified date the subject received unspecified dose of Flulaval (.5 ml, unknown, unknown arm). At an unspecified time after vaccination with Flulaval, the subject experienced injection site pain and product complaint. The subject returned to the clinic for further evaluation. The healthcare considered the events were disabling. The clinic used a 1 inch needle, 30 gauge needle to administer the vaccinations. The office is very concerned about using additional doses of this vaccine and believe there is a quality issue associated with it. The healthcare professional reported that the injection site pain lasted greater than two weeks and the outcome of the events was unspecified.				Y				Y	U				UNK	PVT	PVT		Unknown	The subject's medical history, concurrent conditions, and concurrent medications were not reported. The healthcare professional reported that 2 other subjects experienced injection site pain following administration of Flulaval. Please see cases A0691341A and A0691342A.		A0691343A	1						1	Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA066AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Disabling	Influenza
0304319	01/29/2008	TX	68.0	68		F	01/16/2008	This case was reported by a consumer and described the occurrence of arm soreness in a 69-year-old female subject who was vaccinated with Flulaval for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medical conditions included sulfa allergy. Concurrent medications included Toprol XL, Aspirin, Multivitamins, Calcium salt and Glucosamine. On 15 October 2007 at 16:15 the subject received unspecified dose of Flulaval (unknown, left arm). The subject was not able to specify which vaccine she received. On 15 October 2007, less than one day after vaccination with Flulaval, the subject experienced arm soreness. Two hours after vaccination the subject developed hives that spread to her whole torso. By day five, the subject's torso was covered mainly in the front and stopped under the arms and under the breasts; it was not on her neck. The hives were also no her calves. The subject was treated with Benadryl and Poison ivy lotion. Six weeks later, in November 2007, the events were resolved. This case was reported by a consumer, and subsequently confirmed by a physician, that described the occurrence of arm soreness in q 69-year-old female subject who was vaccinated with FLULAVAL (Glaxosmithkline). On 15 October 2007 at 16:15 the subject received unspecified dose of FLUVAL (unknown, lef arm). The subject was not able to speciy which vaccine she received. On 15 October 2007, less than one day after vaccination with FLULAVAL, the subject experienced arm soreness. Two hours after vaccination the subject developed hives that spread to her whole torso. By day five, the subject's torso was covered mainly in the front and stopped under the arms and under the breasts; it was not on her neck. The hives were also in her calves. The subject was treated with BENADRYL and POISON IVY lotion, Six weeks later, in November 2007, the events were resolved. Follow-up information was received on 30 January 2008 via a physician, which conflicted with the original report, According to the physician, the arm soreness, hives, and itching occurred on 20 October 2007, five days after the subject was vaccinated with FLULAVAL. As of 22 October 2007, the events were resolved. The reportinf physician considered the events to be related to FLULAVAL vaccination.									Y	10/15/2007	10/15/2007	0	UNK	PVT	PVT	Metoprolol succinate; Aspirin; Multivitamin; Calcium salt; Glucosamine	SULFA ALLERGY	The subject had not previously received flu shots. The subject had never had hives.		A0699098A	1						1	Pain in extremity; Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304320	01/29/2008					F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of unspecified event in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On an unspecified date the subject received unspecified dose of Flulaval (unknown0.  At an unspecified time after vaccination with Flulaval, the subject experienced unspecified event.  The reporter declined to provide any other information.  At the time of reporting the outcome of the event was unspecified.				Y					U				UNK	OTH	OTH	The reporter declined to provide concomitant medications.	Unknown	The reporter declined to provide concomitant medications and relevant medical history.  The Flulaval vaccine was not administered at the reporter's office.  The reporter inquired about any complaints associated with this specific lot number of Flulaval.		A0699847A	1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA035AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0304321	01/29/2008	NJ	61.0	61		F	01/16/2008	This case was reported by a physician and described the occurrence of wrong drug administered in a 61-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  The subject's medical history included atrial fibrillation.  Concurrent medical conditions included allergy to dye and hypertension.  Previous and/or concurrent vaccination included influenza virus vaccine; manufacturer unspecified; left arm given on 14 November 2007.  Concurrent medications included Coumadin, Crestor, Altace, digoxin, Synthroid, Nexium and Periostat.  On 14 December 2007 at 08:30 the subject received unspecified dose of Flulaval (.5 unknown, left arm) and experienced wrong vaccine administered.  The subject was supposed to receive a pneumonia vaccine and inadvertently was given Flulaval.  A follow-up call from the consumer was received later on 14 December 2007.  She reported that she inadvertently received a second influenza vaccine (Flulaval) instead of her pneumonia vaccine.  Additional information was provided by the subject and this information has not been medically confirmed by a physician or healthcare professional.  The subject reported at an unspecified time on the same day as vaccination in her left arm with Flulaval, she reported that her left arm felt hot.  Approximately three hours after vaccination with Flulaval, the subject reported that she feels like she is about to have an episode of atrial fibrillation.  She clarified the statement and noted that she feels heart flutters like she has had before previous episodes of atrial fibrillation.  The consumer also reported that she received influenza virus vaccine (unknown manufacturer) on 14 November 2007.  At an unspecified time after vaccination she experienced in the left arm where the vaccine was injected, a sensation of her arm feeling hot which later resolved on an unspecified date.  At the time of reporting the consumer reported that the sense of heat occurrence in the left arm had improved and the feeling of heart flutters was unresolved.									N	12/14/2007	12/14/2007	0	UNK	PVT	OTH	Warfarin sodium; rosuvastatin calcium; ramipril; digoxin; thyroxine sodium; esomeprazole; doxycycline hydrochloride	Unknown	ALLERGY TO DYE; ATRIAL FIBRILLATION; HYPERTENSION.  Allergy to dye was noted to be Ultravis.		A0700283A	1						1	Cardiac flutter; Skin warm; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA038AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304322	01/29/2008	NY				F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in an elderly female subject who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  On an unspecified date the subject received unspecified dose of Flulaval (.5 ml, unknown).  Two days after vaccination with Flulaval, the subject experienced swelling of the arm, redness, soreness and warm to touch.  At the time of reporting the outcome of the events were unspecified. Follow up information was received on 04 April 2008 via a nurse, who reported that the subject  was a 70-year-old female, who received her FLULAVAL vaccination in her left arm. The nurse reported that the onset date of the adverse events was 11 December 2007, and the events were resovled as of 15 December 2007. The reporting healthcre professional considered the events to be related to vaccination with FLULAVAL.				Y					U				Unknown	OTH	OTH		Unknown	This report was the second the nurse reported.  The subject was the mother of one of the physicians in the practice and received Flulaval.  For the first case, see A0700166A.  She also reported three other subjects.  See A0700324A, A0700325A and A0700326A.		A0700322A	1						1	Erythema; Injection site swelling; Pain; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0304323	01/29/2008	NY				U	01/16/2008	This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in an elderly subject of unspecified gender who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  On an unspecified date the subject received unspecified dose of Flulaval (.5 ml, unknown).  Two days after vaccination with Flulaval, the subject experienced swelling of the arm, redness, soreness and warm to touch.  At the time of reporting the outcome of the events were unspecified.				Y					U				Unknown	OTH	OTH		Unknown	The nurse reported a total of five patients.  For the first case, see A0700166A.  The second, the subject was the mother of one of the physicians in the practice and received Flulaval.  See case A0700322A.  For the additional cases, see A0700325A and A0700326A.		A0700324A	1						1	Erythema; Injection site swelling; Pain; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0304324	01/29/2008	NY				U	01/16/2008	This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in an elderly subject of unspecified gender who was vaccinated with Flulaval for prophylaxis. On an unspecified date the subject received unspecified dose of Flulaval (.5 ml, unknown). Two days after vaccination with Flulaval, the subject experienced swelling of the arm, redness, soreness and warm to touch. At the time of reporting the outcome of the events were unspecified.				Y					U				UNK	OTH	OTH		Unknown	The nurse reported a total of five patients. For the first case, see A0700166A. The second, the subject was the mother of one of the physicians in the practice and received Flulaval. See case A0700322A. For the additional cases, see A0700324A and A0700326A.		A0700325A	1						1	Erythema; Injection site swelling; Pain; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0304325	01/29/2008	NY				U	01/16/2008	This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in an elderly patient of unspecified gender who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On an unspecified date the subject received unspecified dose of Flulaval (.5 ml, unknown).  Two days after vaccination with Flulaval, the subject experienced swelling of the arm, redness, soreness and warm to touch.  At the time of reporting the outcome of the events were unspecified.				Y					U				UNK	OTH	OTH		Unknown	The nurse reported a total of five patients.  For the first case, see A0700166A.  The second, the subject was the mother of one of the physicians in the practice and received Flulaval.  See case A0700322A.  For the additional cases, see A0700325A and A0700324A.		A0700326A	1						1	Erythema; Injection site swelling; Pain; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0304326	01/29/2008	WA	50.0			F	01/16/2008	This case was reported by a healthcare professional and described the occurrence of bicep tendonitis in a 50-year-old female subject who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  On 26 October 2007 the subject received unspecified dose of Flulaval at 0.5 ml in the left arm.  At an unspecified time (shortly) after vaccination with Flulaval, the subject experienced bicep tendonitis.  At the time of reporting the event was unresolved.  Follow-up information received on 11 January 2008 indicated that bicep tendonitis began on the same day that Flulaval was administered to the subject, 26 October 2007.  At the time of follow-up, the outcome of the event was unknown, but had previously been unresolved.  In the reporter's opinion, the event was not related to treatment with Flulaval.									U	10/26/2007	10/26/2007	0	Unknown	OTH	OTH		Unknown	The subject has previously received flu shots.		A0700610A	1						1	Tendonitis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLL029AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304327	01/29/2008	CT	62.0	62		M	01/16/2008	This case was reported by a consumer and described the occurrence of difficulty swallowing in a 62-year-old male subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  Subject was healthy and had not experienced any adverse events following previous influenza vaccinations.  On 4 December 2007 at 17:30 the subject received 1st dose of Flulaval (unknown, left arm).  On 12 December 2007, 8 days after vaccination with Flulaval, the subject experienced difficulty swallowing, headache, chills, fever, queasiness and acid reflux.  The subject was seen at a walk in clinic on 16 December 2007.  On 17 December 2007, he was seen by his regular physician.  An upper GI series was done on 18 or 19 December 2007.  An endoscopy was done on 26 December 2007.  Results were not reported.  At the time of reporting the outcome of the events were unspecified.				Y					U	12/04/2007	12/12/2007	8	Endoscopy, 26Dec2007, unknown; upper GI series, Dec2007, unknown.  Upper GI series done on 18 December 2007 or 19 December 2007.	OTH	OTH	no concurrent medications	Unknown	History: Healthy subject and no adverse following previous influenza vaccinations or other vaccinations.  The subject had no relevant medical history or concurrent medications.		A0702002A	1						1	Chills; Dysphagia; Endoscopy; Gastrooesophageal reflux disease; Headache; Nausea; Pyrexia; X-ray with contrast upper gastrointestinal tract	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0303937	01/30/2008	CO	9.0	9		M	01/30/2008	Received vaccinations at 10:00 on 01/29/2008, and immediately reported dizziness and exhibited palor. After lying down pulse was 40, resp 8. Following juice administration pallor improved and B/P was 78/40, pulse 42.  By 10:25 B/P was 98/70, pulse was 60.  Patient reported itching on face above eyebrow and lips.  No visible hives were noted.  Benadryl (30mg) administered as appropriate for weight.  By 11:00 B/P was 92/68, pulse 68, itching did not progress, but patient did report continued lethargy, dizziness and inability to stand unassisted.  Patient referred to primary care and transferred in private vehicle by parent.  On 1/29/2008 received a message from child's physician stating episode was probable syncopal episode.				Y					Y	01/29/2008	01/29/2008	0		UNK	UNK		None	Parent reported multiple allergies, but no allergy to eggs or egg products.  Parent denied any chronic medical conditions.			1						1	Blood pressure; Dizziness; Dysstasia; Heart rate decreased; Lethargy; Pallor; Pruritus; Syncope	FLUN3~MEDIMMUNE VACCINES, INC.~500497P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB171AA~1~IM~LA~HEP A (HAVRIX)~1|TD~SANOFI PASTEUR~U1991CA~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~1359U~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0303943	01/30/2008	NY	25.0	25		F	01/30/2008	Soreness, redness, heat, and swelling at the site injection that was given approximately 24hrs. ago.									U	01/29/2008	01/29/2008	0		UNK	UNK	none	none	none			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2524AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0303944	01/30/2008	MD	41.0	41		F	01/30/2008	Rash, Fever, Vomiting.									Y	12/15/2006	12/15/2006	0	N/A	MIL	MIL	N/A	N/A				1						1	Pyrexia; Rash; Vomiting	FLU3~SANOFI PASTEUR~AFLUA2A2EA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0303949	01/30/2008	GA	0.56	0	.6	F	01/21/2008	Pt a period of 4h shaking, 7 AM, 01-12-08. 3 mild seizures with fever. 1st one afterward seen by paramedics. He felt it was febrile seizure. Seen at ER; found to have UTI infection.				Y					Y	01/11/2008	01/12/2008	1		PVT	PUB	None	? UTI				1						1	Convulsion; Febrile convulsion; Pyrexia; Tremor; Urinary tract infection	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B133AA~2~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2473GA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B54015H~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1319U~1~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0303954	01/30/2008	MA	55.0	55		F	11/27/2007	24 hours after receiving the Pneumonia vaccine she developed hives at the injection site & redness that traveled down to her elbow.  She also developed fever, chills & body aches.									Y	11/17/2007	11/18/2007	1	None	PUB	PUB	Toprol XL; Premplus; hydrochlorothiazide	None	Allergy to sulfa drugs	None~ ()~~0.00~In Patient|None~ ()~~0.00~In Sibling|None~ ()~~0.00~In Sibling	MA0716	1						1	Chills; Injection site erythema; Injection site urticaria; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA050AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~09640~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0303960	01/30/2008	CA	8.0	8		F	01/30/2008	Pt received VARIVAX and INFLUENZA vaccines 2 days ago.  Yesterday she noted swelling, redness and pruritus on right deltoid area.  She came today; on exam the area was a round papule, reddened, swollen and hot of 2 inches diameter.  She was treated with BENADRYL and sent to school.				Y					U	01/28/2008	01/29/2008	1	none	UNK	UNK						1						1	Erythema; Pruritus; Rash papular; Skin warm; Swelling	FLU3~SANOFI PASTEUR~44610~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0645U~2~IM~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0303962	01/30/2008	WA	7.0	7		F	01/30/2008	Pt came home from school on 1/29 c/o pain @ injection site.  Pt had swelling, 1 long by 1/2 wide.									Y	01/28/2008	01/29/2008	1		UNK	UNK		N/A				1						1	Injection site pain; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80956~2~IM~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB171AA~1~IM~RL~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1764U~2~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0303979	01/30/2008	TN	74.0			F	01/29/2008	Red, swollen area/lump at site of vaccine, (L) UE, warm to touch. About 1 cm mass with exam. Pt said it had been slightly larger.									Y				None	PVT	OTH	Glubyride, ASA, Ca and D, Ranitidine, B12, KlonCon, Lasix, Toprol, Hydrolocine; Actonel	None	Allergy - eggs; Med cond: Type 2 DM - neuropathy, HTN, Obesity, CAD, RAD, pernicious anemia			1						1	Injection site erythema; Injection site mass; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2489AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~1415U~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0304032	01/31/2008	OH	9.0	9		F	01/21/2008	Had influenza symptoms (fever, cough) and positive nasopharyngeal swab for influenza about 2 months after influenza vaccine.				Y						11/21/2007	01/14/2008	54	NP swab for influenza Ag	PUB	PUB	None	None	None	Flu~Influenza (Seasonal) (no brand name)~4~2.00~In Sibling|Flu~Influenza (Seasonal) (no brand name)~2~2.00~In Sibling		1						1	Cough; Influenza like illness; Influenza serology positive; Pyrexia	FLU3~SANOFI PASTEUR~U2527AA~2~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~10604~3~UN~LA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0304034	01/31/2008	NJ	52.0	52		F	10/23/2007	Rash on (L) shoulder w/i 17 hours of vaccine to (R) arm. Rash was dense and size of fist and turned into all blisters w/i 3 days. Also had 5 sites of large blisters with extreme itch on upper arms and wrists of both arms w/i 24 hrs.				Y					Y	10/15/2007	10/16/2007	1	N/A	OTH	PUB	N/A	None	None			1						1	Blister; Pruritus; Rash	FLU3~SANOFI PASTEUR~U2448AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0304037	01/31/2008	MD	0.6	0	.6	F	01/23/2008	12/22/07 pt. seen in office with bruise on (R) thigh where flu shot given - red - hard - raised. Dx with cellulitis, given Omnicef. 12/27/07 Recheck, fever started - had bloody discharge, sent for cultures. After opened wound by doctor, started on Bactrim. 12/29/07 Seen again to check wound. 12/31/07 Opened and drained again.				Y					U	11/28/2007	12/22/2007	24	Anaerobic and aerobic culture sent to lab 12/27/07. Results reported 12/31/07 - negative with no growth.	PVT	PVT	None listed	None	None listed, NKA			1						1	Bloody discharge; Culture wound negative; Injection site bruising; Injection site cellulitis; Injection site erythema; Injection site induration; Injection site swelling; Pyrexia; Surgery	FLU3~SANOFI PASTEUR~UT2474FA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0304058	02/01/2008	ID	1.5	1	.5	M	01/31/2008	Febrile seizure 1/29/08.				Y					Y	01/23/2008	01/29/2008	6	None	PVT	PUB	None	None	None			1						1	Febrile convulsion	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B067AA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2494BA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB242AA~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0866U~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0304069	02/01/2008	OH	0.5	0	.5	F	02/01/2008	Progressive swelling and erythema around vaccine injection site x 3 days.  Mother also noted tactile temperatures.  Swelling and erythema spread around the circumference of the right thigh and extended to the buttocks.  Patient was admitted to the hospital and transferred to the pediatric intensive care unit on the 2nd day.  Patient was treated aggressively with IV antibiotics for presumed cellulitis.  Dermatology was consulted and following a skin biopsy suggested that Sweet's syndrome secondary to the vaccine was a probable cause.  Patient was discharged home with po antibiotics and scheduled to follow-up in the ID and derm clinics in 4 days. 3/3/08-recordsreceived for DOS 1/23-1/30/08-DC DX:Contact dermatitis/other eczema. Cutaneous candidiasis. cellulitis. fever. Presented with swelling and redness of right thigh times 3 days. Temp 102.2. PE circumferential erythema, warmth and mild swelling over right proximate thigh extending over entire right buttock and down down thigh. Irritable.					Y	7			Y	01/21/2008	01/22/2008	1	At time of presentation:  lumbar puncture normal (WBC 2, 39% lymphocytes, gluc 54); WBC 10.7;  CRP 18.2;  negative blood, sputum, and skin cultures;  MRI negative for myositis or osteomyelitis;  US of buttocks negative for abscess formation 3/3/08-records received-LP normal. MRI oflegs showed edema and inflammation of fascia with no infiltration of deep fascial layers. Neutropenia, ANC 900. Skin biopsy Sweet's like eruption.	UNK	UNK	hydrocortisone cream, Reglan, Mmylicon drops, Tylenol, poly-vi-sol (iron), Aquaphor ointment	none	GERD, Bronchopulmonary dysplasia (BPD), ROP, PDA at birth, and prematurity (born at 27 weeks GA) 3/3/08-records received- PMH: 27 week premie twin. BPD. GERD resolved. Laser surgery for ROP. S/P PDA ligation.			1						1	Acute febrile neutrophilic dermatosis; Biopsy skin; Blood culture negative; Body temperature increased; C-reactive protein increased; CSF glucose normal; CSF lymphocyte count normal; CSF white blood cell count negative; Cellulitis; Culture negative; Injection site erythema; Injection site swelling; Lumbar puncture normal; Nuclear magnetic resonance imaging normal; Sputum culture; White blood cell count	DTPHEP~UNKNOWN MANUFACTURER~~UNK~IM~LL~DTP + HEP B (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~UT2460AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0304104	02/01/2008	CA	3.0	3		F	01/24/2008	Henoch - Schonlein Purpura (HSP) Rash 24-48 hours after Hep A #2, Fluzone. No Treatment. No complications. Self resolved in < 1 wk.									Y	12/31/2007	01/01/2008	1	U/A negative	PVT	PVT		None	None			1						1	Henoch-Schonlein purpura; Rash; Urine analysis normal	FLU3~SANOFI PASTEUR~U2525AA~3~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB17VA~2~UN~LL~HEP A (HAVRIX)~1	USA		Influenza
0304110	02/01/2008	GA	0.6	0	.6	F	01/16/2008	Generalized urticarial rash, itching.  No respiratory symptoms.  Prescribed prednisolone orally.  Rash resolved by 1/17/08.									Y	01/15/2008	01/16/2008	1	None	PVT	PVT	None	None	None			1						1	Rash generalised; Urticaria	DTAP~SANOFI PASTEUR~C2670AA~3~~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2459PA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0538U~3~~RL~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~B70145A~2~~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1388U~3~~~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0304123	02/01/2008	FL	1.5	1	.5	F	01/28/2008	Patient received DTaP vaccine 12/18/07 IM left thigh (L2606AA).  Exp. 3/15/09.  Within 1-2 weeks, patient had painful lesion at injection site.  Lesion became fluctuant and was I & D'd 1/22/08 - culture grew Enteropacter agglomerams.  03/11/2008 MR received from PCP for 12/18/07-1/31/2008. Pt seen for WCC on 12/18/07 with cough and congestion x 5 days noted. Vax given. Seen again 1/22/08 with c/o cough, congestion and injection site redness and tenderness at DTaP site. (+) Abscess L thigh-fluctuant.  Improving by 1/31/08 after tx with Zithromax and Bactroban									Y	12/18/2007	12/18/2007	0	Positive Enterobaceter agglomerans in wound culture from I&D. Labs and Diagnostics:  wound cx (+) for Enterobacter agglomerans.	UNK	UNK		cough and congestion x 5 days	Pt with h.o hypoplastic L heart syndrome.  H/O sterile abscesses bilat. legs s/p immunizations 1/07. PMH: HLHS, GERD. Murmur noted on PE.  NKDA.			1						1	Culture wound positive; Incisional drainage; Injection site pain; Injection site reaction; Skin lesion; Culture positive; Enterobacter infection; Injection site abscess	DTAP~SANOFI PASTEUR~L2606AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U24816A~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0862F~1~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|DTAP~SANOFI PASTEUR~L2606AA~4~UN~LL~DTAP (DAPTACEL)~2|FLU3~SANOFI PASTEUR~U24816A~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|MMR~MERCK & CO. INC.~0862F~1~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~2|VARCEL~MERCK & CO. INC.~1654U~1~UN~RL~VARICELLA (VARIVAX)~2	USA		Influenza
0304135	02/01/2008	IL	53.0	53		M	02/01/2008	Patient still complains of arm soreness after receiving the flu vaccination on 11/2/07.									U	11/02/2007	11/16/2007	14		UNK	UNK	Unknown		Unknown			1						1	Pain in extremity; Injection site pain; Pain	FLU3~SANOFI PASTEUR~U2514AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2514AA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0304136	02/01/2008	NY	2.0	2	1	F	02/01/2008	Erythema of left thigh at site of injection.  Right thigh without reaction.									U	01/30/2008	01/31/2008	1	None	UNK	UNK		None	None	none~ ()~~0.00~Patient		1						1	Injection site erythema	DTAPH~SANOFI PASTEUR~U2070BA, UF105A~1~IM~LL~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~UT2460BA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB184BA~2~IM~RL~HEP A (HAVRIX)~1	USA		Influenza
0304137	02/01/2008	DE	0.56	0	.6	F	02/01/2008	Hep A was given to a 6 month old female during her routine well child check.									U	02/01/2008	02/01/2008	0		UNK	UNK	Amoxicillin 400mg/5ml & Tylenol 80 mg/0.8ml ordered at time of visit.	Upper Respiratory Infection				1						1	Inappropriate schedule of drug administration	DTAP~SANOFI PASTEUR~C2765AA~3~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2524AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB200BA~1~ID~RA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~A0170~3~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~C35171~1~IM~LA~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~11954~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0304139	02/01/2008	TN	11.0	11		F	02/01/2008	Varicella vaccine given in right deltoid.  On the day after the vaccine was given, the patient developed swelling and erythema circumferentially on her right upper arm.  She also had fever and 3 episodes of diarrhea.									Y	01/29/2008	01/30/2008	1		UNK	UNK	None	None				1						1	Diarrhoea; Erythema; Oedema peripheral; Pyrexia	DTAP~SANOFI PASTEUR~C2798AA~5~IM~RA~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500498P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB214AA~2~IM~LA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1577U~2~IM~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0304155	02/01/2008	MO	12.0	12		F	01/21/2008	None reported.  No adverse events.										01/21/2008				PVT	PUB		None				1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U2524AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB171AA~3~IM~RA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~0523U~4~IM~RA~HPV (GARDASIL)~1	USA		Influenza
0304143	02/02/2008	NM	45.0	45		M	02/02/2008	Immediate sensitivity and soreness at injection site - then within a day or two the tingling and numbness began to move through the upper chest area.  Within a couple more days an upward progression beginning with the feet of tingling, numbness, and finally loss of nerve and muscle ability. He was admitted to Hospital on 11/21 with the diagnosis being Guillain-Barre Syndrome thought secondary to his recent influenza shot.  His symptoms progressed rapidly loss of muscle and nerve function in all parts of his body as well as respiratory failure.  He was immediately placed in ICU and required intubation and mechancial ventilation for 7 days in addition to daily infusions of gammaglobulin.  He was later transferred to InPatient Rehab on 12/3/07 for continued rehabilitation for physical therapy, occupational therapy, Speech and Language Pathology. 4/01/08 Reviewed hospital medical records of 11/21-12/03/2007. FINAL DX: Guillain-Barre syndrome, thought secondary to recent flu shost; HTN; and weakness. Records reveal patient experienced lightheadedness, HA, neck stiffness, weakness & tingling of feet, lower legs & fingers ascending & progressing rapidly over 3 days.  Seen in outlying ER & transferred to higher level of care.  Admitted to ICU.  Continued to deteriorate, developed respiratory failure & was intubated 11/23.  DTRs absent in LEs.  Neuro consult obtained.  Tx w/IVIG & improved  Extubated on 11/27.  Continued to improve w/PT & transferred to inpatient rehab.			Y	Y	Y	13			N	11/07/2007	11/08/2007	1	Continued therapy along with medications.  All medical records are available by the patient. The vaccination was offered through the patient's employee at the work site  LABS: MRI of spine revealed degenerative changes.  CT of head WNL.  Blood & urine c/s neg.	UNK	UNK		None	PMH: back pain x several years.  HTN.  Hypercholesterolemia.			1						1	Guillain-Barre syndrome; Hypoaesthesia; Injection site hypersensitivity; Injection site pain; Intubation; Mechanical ventilation; Muscular weakness; Respiratory failure	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA082AA~2~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Life Threatening,Hospitalisation	Influenza
0304144	02/02/2008	MI	50.0	50		M	02/02/2008	Extreme pain 4 hrs at site post injection with redness, 102-103 fevers next 48-72 hrs back pain, joint pains, diarrhea, severe headache not recovered yet, same rxn as 4 years ago but was forced to get flu shot against wishes.									U	02/01/2008	02/01/2008	0		UNK	UNK	none	none	hx of previous influenza vaccine reaction as described above	same reaction~Influenza (Seasonal) (no brand name)~~46.10~Patient		1						1	Arthralgia; Back pain; Diarrhoea; Headache; Injection site erythema; Injection site pain; Pyrexia; Similar reaction on previous exposure to drug	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80684~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0297815	02/03/2008	CT	3.0	3		F	02/03/2008	Vaccine administered 11/15/07 at ~9AM, symtoms of leg pain occurred at ~2-3PM that afternoon.  Patient went to the ER at midnight after not being able to sleep, ER took X-rays and gave painkiller intravenously.  Discharged, and we were instructed to bring her to pediatrician next day.  Pediatrician instructed her to go to Hosptial ER.  Patient was admitted to ER again on 11/16/07.  Toxic (transient) synovitis was diagnosed.  Anti-inflammatory was administered thru IV, and patient was discharged.  At home, patient had a temperature of 102-103, but eventually slept thru the night.  The morning of 11/17/07, patient woke up with a bloody discharge in her pull-up.  We went back to Hospital, and patient was diagnosed with an intussusception.  A therapeutic air enema was adminsitered, and patient had to stay in hospital for observation overnight in case intussusception re-occurred.  Patient had a full recovery.			Y	Y	Y	1			Y	11/15/2007	11/15/2007	0	X-rays, ultrasound (for intussusception), blood work, air-enema	UNK	UNK		None	None			1						3	Blood test; Bloody discharge; Body temperature increased; Enema administration; Insomnia; Intussusception; Pain in extremity; Synovitis; Ultrasound scan; X-ray	FLU3~SANOFI PASTEUR~U2465AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Life Threatening,Hospitalisation	Influenza
0304220	02/04/2008	CT	46.0	46		F	01/28/2008	SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 18 January 2008 from a patient.  A 46-year-old female patient, with a medical history of seasonal allergies, had received a right deltoid, intramuscular injection of Fluzone SV 2007-2008, lot number U 2491AA, on 23 October 2007 in the a.m.  At 6:00 p.m. on the same day, the patient developed hives on her face, lips, and ears.  She was examined by a physician twice and treated with Benadryl and prednisone.  The symptoms resolved but returned when the patient was no longer taking the prednisone.  The patient indicated that egg products may possibly cause similar symptoms.  The patient had unspecified blood testing for allergies, but results were not provided.  At the time of this report, the patient had not recovered.				Y					N	10/23/2007	10/23/2007	0	The patient had a blood test for allergies for which results were not provided.	UNK	UNK	ZETARID; thyroid medication	She had no illness at the time of vaccination.	The patient had a past medical history of a possible allergy to eggs, seasonal allergies, acid reflux, and unspecified thyroid disease.		200800212	1						1	Allergy test; Blood test; Urticaria	FLU3~SANOFI PASTEUR~U2491AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0304226	02/04/2008	AZ	52.0	52		F	01/31/2008	SERIOUSNESS: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 06 November 2007 from a health care professional.  A 52-year-old female patient, with a history of allergic rhinitis and glaucoma, had received a right deltoid, intramuscular injection of Fluzone SV 2007-2008, lot number not reported, on 25 October 2007.  Immediately post-vaccination, the patient developed a sore, painful arm.  The patient was examined by a physician 11 days later and was experiencing an inflamed subacromial bursa.  Per the reporter, it appeared that the vaccination had been given very high, possibly into the acromium process.  C-reactive protein was four times the normal limit.  At the time of this report, the patient had not recovered.  Follow-up information was received on 22 January 2008 from a health care professional.  After review of the case, it was decided to upgrade the case to serious due to the patient's persistent pain.  The lot number of Fluzone received by the patient was U24978A, expiration date 30 June 2008.  Laboratory test results (date not specified) included Sed rate (7), CBC differential (normal), CRP (4.1 to 3.7).  According to the reporter, the vaccination had likely been injected into the subacromial and subdeltoid bursa.  The patient was diagnosed with suspected subacromial bursal injection of Flu vaccine with sterile bursitis.  Corrective treatments included NSAIDs (not specified) and a follow-up consult with an orthopedic physician who administered a subacromial steroid injection.  The patient showed some improvement after the subacromial steroid injection but had not yet recovered from the event.				Y					N	10/25/2007	10/25/2007	0	Sed rate: 7; CBC and differential: normal; CRP: 4.1 to 3.7	OTH	OTH	SINGULAIR; VALATIR; NASONEX; PREMARIN	The patient was not ill at the time of vaccination.	The patient had a history of allergic rhinitis and glaucoma.  The patient was not ill and had not received any vaccinations during the four week period prior to receipt of Fluzone.		200703748	1						1	Bursa disorder; Bursitis; C-reactive protein increased; Differential white blood cell count normal; Full blood count normal; Immediate post-injection reaction; Inflammation; Pain in extremity; Red blood cell sedimentation rate increased; Wrong technique in drug usage process	FLU3~SANOFI PASTEUR~U24978A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0304228	02/04/2008		31.0			F	01/31/2008	Information was received on 22 January 2008 from a literature article.  A portion of this article is verbatim and is in quotes.  Thimerosal is a mercury derivative used as a preservative and bacteriostatic agent.  We report an immediate hypersensitivity reaction after skin testing with an adult influenza vaccine that seems to be due to thimerosal.  The patient is a 31-year-old woman with seasonal allergic rhinitis and irritable bowel syndrome.  She developed conjunctival erythema and local pain after using a thimerosal containing contact lens solution 15 years before the evaluation.  She then switched to and tolerated the same brand of contact lens solution without thimerosal.  She received a booster dose of tetanus toxoid (0.05mg of thimerosal per 0.5 mL dose) 2 1/2 years before this evaluation without any difficulty.  Because of her concerns regarding thimerosal, she received a thimerosal-free pediatric influenza vaccine 4 months earlier with no adverse events.  A skin prick test using the full-strength adult influenza vaccine (25mg of thimerosal per 0.5 mL dose) generated a wheel consisting of a 3-mm induration with 25 mm of erythema with satellite lesions.  Within 20 minutes, the patient developed generalized pruritus without hives, throat tightness, and a dry cough without wheezing on auscultation.  Although her vital signs were stable, she was diffusely pruritic and short of breath.  She was treated with 0.3 mL of epinephrine intramuscularly and 180 mg of fexofenadine orally.  All symptoms resolved within 10 minutes.  The patient returned two months later for a second set of skin prick tests with Pediatric Fluzone vaccine (Thimerosal-free), Tetanus toxoid vaccine (manufacturer Sanofi Pasteur), and Decavac vaccine.  The testing included histamine control and saline glycerol control.  No noteable reaction was observed.  Per the reporter, the patient's reaction was directly observed; and there were no confounding ingestants.  Second, there was documented immediate hypersensitivity reaction to the vaccine containing thimerosal, and lack of a reaction to a similar vaccine without thimerosal.  Owing to the patient's history of contact sensitivity to thimerosal, the temporal relationship between skin testing with the adult vaccine and the clinically obvious reaction, and the otherwise similar constituents of the adult and pediatric vaccines, we postulate that this reaction was an IgE-mediated immediate hypersensitivity reaction to the thimerosal in the vaccine and that thimerosal probably acts as hapten.  However, this was not formally proved by invitro IgE measurements, and therefore, a non-IgE mechanism is possible.  Per the reporter, it is believed that the patient tolerated earlier exposure to the tetanus vaccine and did not have skin test reactivity to the tetanus vaccine because the dose of thimerosal was much less than in the adult influenza vaccine (0.05 vs 25mg).				Y					Y					UNK	UNK			Seasonal allergic rhinitis and irritable bowel syndrome.  Conjunctival erythema and local pain after using a thimerosal-containing contact lens solution 15 years before this event.  She then switched to, and tolerated the same brand of contact lens solution without thimerosal.  She received a booster dose of tetanus toxoid (0.05 micrograms of thimerosal per 0.5 mL dose) 2 1/2 years without any difficulty.		200800235	1						1	Cough; Dyspnoea; Erythema; Induration; Pain; Pruritus; Throat tightness; Urticaria	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0304232	02/04/2008		2.0			F		2-year-old received double the dose of flu vaccine.  Received 0.5 mL, should have received 0.25 mL.  This was her second scheduled dose.  Just occurred, awaiting return call from pediatrician regarding what to do.  Nurse administering could have been distracted, 5 children to do at same time.  Immediately after administration, nurse realized she grabbed the wrong syringe.											11/21/2007			UNK	UNK			Asthma			1						1	Incorrect dose administered; Medication error	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0304233	02/04/2008	MA	68.0	68		F	12/11/2007	11/02/07 - Severe pain Lt arm, shoulder and now down back.  Warm arm.  Got pain med at ER.  Referral to ortho MD who took X-Ray.  Dx - unable to read.  To have ultra sound.				Y					U	11/01/2007	11/02/2007	1	X-ray and Physiotherapy	PUB	PUB	Plavix; Lexipro; Lisinopril; Meforman; Lipitor	History of strokes, HTN, DM	No allergies			1						1	Back pain; Pain in extremity; Physiotherapy; Skin warm; X-ray	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA050AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0304239	02/04/2008	AZ	1.5	1	.5	M	01/18/2008	Febrile seizure in 24 hours of receiving vaccine.  History of previous febrile seizure times 1.  Child also with bronchial symptoms (like sib).				Y					Y	01/15/2008	01/16/2008	1		PVT	PUB		Flu, Bronchiolitis	Eczema			1						1	Febrile convulsion	FLU3~SANOFI PASTEUR~U2481FA~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0304240	02/04/2008	CT	2.0	2	.5	M	01/30/2008	HSP - dev. vomiting, viral exanthem on 1/4/08, received vaccine 1/9/08, dev. purpural petechiae subsequently - diagnosed with HSP 1/9/08; Also dev. Nephritis, including gross hematuria 1/14/08. Rx with steroids				Y					N	01/07/2008	01/09/2008	2	UA - 3+ blood, 3+ Ketones; 3+ protein	PUB	PUB	none	Abd pain and rash	Eczema			1						1	Haematuria; Henoch-Schonlein purpura; Nephritis; Petechiae; Purpura; Urine analysis; Viral rash; Vomiting	FLU3~SANOFI PASTEUR~U2481GA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0304251	02/04/2008	NC	1.0	1	.0	M	01/29/2008	Fever 104 degrees, pallor, perioral cyanosis & trembling.  Emesis x1.  Rapid onset within 24 H of vaccinations.  Transported to local ED where septic W/U was negative.  No other signs/symptoms of disease.  Fully recovered within 48 H.				Y					Y	01/25/2008	01/26/2008	1	CXR; abdom xray; BCx; UCx; CBC; U/A; CMP.	PVT	PVT	None	None	None			1						1	Abdominal X-ray; Blood culture; Chest X-ray; Culture urine; Cyanosis; Full blood count; Metabolic function test; Pallor; Pyrexia; Tremor; Urine analysis; Vomiting	FLU3~SANOFI PASTEUR~2508AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB217AA~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1313U~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C41337~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1578U~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0304262	02/04/2008	AZ	13.0	13		F	02/04/2008	After receiving immunizations client immediately left clinic with mother and siblings.  She felt light headed and fainted.  This was not witnessed by any staff members.  Mother reported child struck right cheek when she fell.  At home developed nausea/vomiting and became very tired.  Mothe took child to emergency department for evaluation.				Y					Y	01/02/2008	01/02/2008	0	Accucheck, Postural Blood Pressure	UNK	UNK	None	None	None			1						1	Blood glucose; Blood pressure; Dizziness; Fatigue; Head injury; Nausea; Syncope; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500492P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~C2771AA~1~IM~RA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~0525U~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2538AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B016BA~1~IM~LA~TDAP (BOOSTRIX)~1	USA	Emergency room visit	Influenza
0304264	02/04/2008	MI	45.0	45		F	02/04/2008	Twitching in left thumb one day following influenza injection.  Parasthesia left foot, progressing to right foot and bilat hands.  Twitching of various body parts.  Banding discomfort and nerve pain in extremities.  Shakiness, nervousness, night sweats, nausea, neck and back discomfort, lip tingling, exhaustion.  Symptoms ongoing since 11/2/2007.  Seeing various doctors/specialties including neuro, ID, Rheum.  02/25/2008 Lengthy neurology and endocrinology consults received dated 1/25/08 and 2/12/2008 respectively with no definative DX provided. Pt reported twitching of the L thumb, tingling of both feet, extreme fatigue, upper back pain, neck pain, shoulder blade pain, LBP, flank pain, calf pain, cramping of the foot, limb heaviness,  weakness, muscle twitching, night sweats and formication.  PE (+) for minimal ankle edema, 3+ DTRs at the patellae otherwise WNL. No Dx made at this time by neuro. Endocrine consult for mildly elevated Cacium levels with no clear Dx.  Plan to follow over time.				Y					N	11/01/2007	11/02/2007	1	Labs and Diagnostics:  MRI brain and cervical spine (-), X-rays of lumbosacral spine and tib-fib (-), EMG and NCS (-), all labs WNL except Ferritin low at 29.6 and Ca-PTH minimally elevated at 10.3 with normal PTH of 38.  Thyroid US (+) shows subtle echoic region requiring further eval. Bone density scan (+) for osteopenia of lower spine. Renal US WNL.	UNK	UNK		? sinusitis	Bactrim, Avelox, Erythromycin, IVP and CT dye. PMH: scratchy throat and tongue burning as well as perianal boil at time of vax. Recurrent hematuria, ITP as a child, intestinal erosion, T&A, breast bx, R knee scope, ? sero (-) osteoarthritis, ? Crohn's Disease.  Allergies to IVP dye, EES, Avalox, and sulfa.  Fam hx of autoimmune diseases.			1						1	Fatigue; Muscle twitching; Musculoskeletal discomfort; Nausea; Nervousness; Night sweats; Pain in extremity; Paraesthesia; Paraesthesia oral; Tremor	FLU3~SANOFI PASTEUR~U2505AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0304266	02/04/2008	MO	45.0	45		F	02/04/2008	Patient and I took shots through a drive through clinic on october 10 2007. Her Left arm puffed up RED after the shot. The area was 3x 2 Square area. Then It went away. On Oct 26 she was stung on the face by a large mosquito. She became sick after that and has been sick ever since then. She has pain all over her body, her hair is falling out, her hair quit growing on her legs and her underarms. She has horrible burning under her scalp, spreading down her back and spreading from her chest up towards her neck as off this morning. It's red splotchy and burns horribly. She has not been able to sleep since the shot. She stairs at the ceiling at night and has not slept since then even with sleep meds. She catches cat naps during the day maybe 1 or 2 hours. Patient was first put in the hospital for 5 day's before they found out she had C-Diff. The second time she had almost 0% potassium and was hospitalized for another 5 day's in the (PCU) pulmonary care unit. She was very sick but still has the burning and her hair is falling out in clumps. Before all of this happend she was a happy go lucky house wife taking care of me (because I am 100% diabled. She is now 100% disabled due to this illness. Please come up with an answer to the burning and hair loss it's very difficult to watch her in so much pain (Submitted by her husband).  2/14/08 Reviewed medical records which reveal patient experienced rash, burning skin, nausea & diarrhea, low grade fever.  Admitted 11/21-11/28/2007.  GI consult done.  Developed grossly bloody diarrhea.  Also had recent exposure to shingles & family member w/diarrhea, had a recent cat scratch & recent mosquito bite.  Cat scratch & mosquito bite areas were swollen & indurated.   D/C Dx: diarrhea, resolved; gastric erosions/ulcer, H. pylori neg; grade A esophagitis; duodenitis.  Diarrhea & fatigue recurred & re-admitted 12/14-12/17/2007.  Tx w/dual antibiotics & improved.  D/C dx: c.diff colitis. FINAL DX: None provided.			Y	Y	Y	10		Y	N	10/25/2007	10/31/2007	6	Had C-Diff has recovered from that. Had many tests I don't have any info on what tests were performed. 11/21 LABS: EGD abnormal & colonscopy WNL.  CT abdomen/pelvis revealed small liver cyst.   C. diff (-). 12/14/ LABS: c. diff (+). CXR WNL.	MIL	UNK	Season ale (Birth Control), Citalopram, hydrocodone, Atenolol, citalopram, topimate, tramadol, hydrochlorothiazide	None	Heart Murmur PMH: anxiety, rash, chronic back pain, herniated disc, DJD, migraine HAs, depression, HTN.  Recent death of brother w/ALS.  Allergy: lisinopril, caused painful itchy rash.			1						1	Alopecia; Burning sensation; Clostridial infection; Clostridium difficile toxin test positive; Erythema; Laboratory test; Oedema peripheral; Pain; Sleep disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0304269	02/04/2008	NC	1.04	1	.0	M	02/04/2008	RASH ALL OVER BODY STARTED 01-28-2008.									U	01/18/2008	01/28/2008	10	NONE REASSURANCE	UNK	UNK		OTITIS				1						1	Rash generalised	FLU3~SANOFI PASTEUR~U2508AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~U2508AA~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B70145B~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~U0828U~4~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0304270	02/04/2008	OH	27.0	27		F	02/04/2008	Eye lids began swelling within 24 hours of vaccine administration.  Next day developed rash on face and neck.  Sought treatment in emergency room.  Treated with Prednisone, Benadryl and Doxycycline per patient report.				Y					Y	02/01/2008	02/01/2008	0	None known	UNK	UNK	None	None	None known			1						1	Eyelid oedema; Rash	FLU3~SANOFI PASTEUR~U2505AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0304283	02/04/2008	OH	60.0	60		M	02/04/2008	At 10:30 AM had a flu vaccine on 10/26/07.  On 11/01/07 came to ER 10:16 AM with c/o persistent pain from site to wrist in L arm.  Doesn't radiate to thumb & little finger, c/o nausea with pain.  Pain 10/10 sharp.  Has also trapezius pain intermittently.  Came in with EP, had full workup.  Dilaudid x2, CT of chest, CXR.				Y					U	10/26/2007	11/01/2007	6	CT of chest; CXR	PUB	UNK		No				1						1	Arthralgia; Chest X-ray; Computerised tomogram; Injection site pain; Musculoskeletal pain; Nausea; Pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA280CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0304123	02/05/2008	FL	1.5	1	.5	F	02/04/2008	Pt with abscess L thigh s/p injection 12/18/07-Pasteur L2606AA Exp 3/15/09.  Culture grew E. agglomerans.  I&D done 1/22/08.				Y					Y	12/18/2007	01/05/2008	18	Positive E. agglomerans in culture	PVT	PVT	Albuterol; Orapred; Augmentin	None	Hypoplastic L heart syndrome; asthma; GERD	abscess thigh 2/07 sp vacccines given 1/8/07~DTaP + HepB + IPV (Pediarix)~UN~0.50~In Patient		1						2	Culture wound positive; Incisional drainage; Injection site pain; Injection site reaction; Skin lesion; Culture positive; Enterobacter infection; Injection site abscess	DTAP~SANOFI PASTEUR~L2606AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U24816A~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0862F~1~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|DTAP~SANOFI PASTEUR~L2606AA~4~UN~LL~DTAP (DAPTACEL)~2|FLU3~SANOFI PASTEUR~U24816A~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|MMR~MERCK & CO. INC.~0862F~1~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~2|VARCEL~MERCK & CO. INC.~1654U~1~UN~RL~VARICELLA (VARIVAX)~2	USA	Emergency room visit	Influenza
0304297	02/05/2008	CT	17.0	17		M	02/05/2008	Persistent pain in left upper arm.  Several weeks after administration and following very vigorous physical exercise sharp exacerbation in pain.									Y	12/03/2007	01/14/2008	42		UNK	UNK			osteosarcoma			1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2481AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0304338	02/05/2008	CA	53.0	53		M	01/15/2008	Development of right brachial plexitis.  Injection given 10/24/2007.  Symptoms developed ~ 1 wk later.  Neuropathic pain nonresponsive to treatment.  Empiric course of high dose steroids ~ 3-4 wks after onset.  EEG & NCS confirm brachial plexitis.  Pt seen by neurology, no history of trauma.  Continuing pain but improving.  03/10/2008 Consult letter dated 12/4/07 received from PCP with DX: Probable Right Brachial Neuritis. Pt reported significant aching in R arm following DPT in August 2007.  Pt then received Flu shot in L arm on 10/24/07.  Following this pt developed severe R arm pain, immobilizing the arm to minimize it. ROM intact. Fasciculations noted in the region of the tricep.  Sleep disrupted 2' to pain. PE WNL except decreased pinprick in the distribution of the R axillary nerve and 1+ DTRs at the R biceps and brachioradialis. 03/11/2008 MR received from neuro consult (see above) 12/4/07 with c/o R arm pain following flu shot. 1/20/2010 Still with persistent brochial pleats right arm; symptoms are less prominent however.  Persistent pain from brochial plexitis on the right. Expected time to resolve> 6months.				Y				Y	N	10/24/2007	10/31/2007	7	Normal CMET/CBC/ESR/ANA/Serum electropheresis/CXR/Lyme serology; Abnormal EEG and NCS 1/7/2008 Labs and Diagnostics: EMG/NCS c/w brachial neuritis. ESR 4.	PVT	PVT	None	None	None. PMH: none. NKDA.			1						1	Antinuclear antibody; Borrelia burgdorferi serology negative; Brachial plexopathy; Chest X-ray; Electrophoresis protein normal; Full blood count; Nerve conduction studies abnormal; Neuralgia; Red blood cell sedimentation rate normal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLL061AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Disabling	Influenza
0304339	02/05/2008	NC	1.0	1	.0	F	01/23/2008	Temperature.  Tylenol did not help.  About 2 days later went to ER and in there thought high temperature from flu shot.  No other symptoms noted.  Child slept a lot over next few days.  Ran 104 temp approximately 4 days later.				Y					Y	11/19/2007	11/19/2007	0		PUB	PUB					NC08019	1						1	Body temperature increased; Hypersomnia	DTAP~SANOFI PASTEUR~U2289AA~3~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2435AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0527~3~SC~RL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~B47442E~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0304340	02/05/2008	NC	2.0	2	.1	F	01/23/2008	Started running fever 4-5 hrs after flu shot administered.  On about day 2 went to ER & Dr there thought fever related to flu shot.  No other s/s noted.  Child slept a lot of next few days.  Ran 104 temp x4 days total.				Y					Y	11/19/2007	11/19/2007	0		PUB	PUB					NC08020	1						1	Hypersomnia; Pyrexia	FLU3~SANOFI PASTEUR~U2435AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0304345	02/05/2008	NC	47.0	47		F	02/04/2008	Received Tdap vaccine on 12/10/07 in right deltoid has had burning, painful sensation since receiving vaccine to right shoulder.				Y					U	12/10/2007	12/10/2007	0		UNK	UNK	Ibuprofen prn	No	None			1						1	Burning sensation; Musculoskeletal pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA625AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|TDAP~SANOFI PASTEUR~C2769AA~1~IM~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0304367	02/05/2008	CA	1.5	1	.5	M	01/31/2008	Myocarditis leading to pulmonary edema, respiratory distress and needing intubation. Admission to PICU for 7 days. Initial treatment with Ceftriaxone, Niburone drip. Now on Captopril and Lasix.  02/19/2008 MR received for DOS 1/22-31/2008 with D/C DX:  Acute Myocarditis.  Acute Pancreatitis.  Child presented with 2-3 day hx of fever, cough, and increased WOB. Pt had vomited x 2.  Pt developed worsening respiratory distress with tachypnea and wheezing despite albuterol nebs and Prelone. Upon arrival in ED pt had an O2 sat of 70% on RA and significant retractions. Breath sounds were diminished on the R with bilateral rales. Pt was intubated due to worsening status. Admitted for ? status asthamticus with respiratory failure.  Cardiac consult with DX of myocarditis and later pancreatitis.  Feeding tube inserted. TXd with Milrinone with improvement in LV fxn and Actigall for gallbladder sludge.  Amylase and lipase had stablized by d/c. Stable or RA following extubation.			Y		Y	8			Y	01/18/2008	01/21/2008	3	Echo - initial ejection fraction 20%. Now recovered with normal ventricular function.  Labs and Diagnostics:  WBCs 17.1 with 58 neutrophils and 13 bands.  CRP 5.56.  CXR showed RML infiltrate. Blood gases abnormal-acidosis.  Echocardiogram showed an EF of 20%, mild tricuspid and mitral regurg, mildly dilated L ventricle and moderate to severely decreased LVF. CXR (+) for patchy infiltrates, and later perihilar pulmonary edema.  Lipase 281. Amylase 234. LDH 350 Coxsackie virus antibodies (-).  CSF enterovirus PCR (-).  CMV IgG (+), CMV IgM (+). Mycoplasma IgG increased.  Mycoplasma IgM increased	PVT	UNK	Amoxicillin; Prelone	None. Last check-up - well on 1/18/07	None. PMH: Bronchilitis.			1						1	Echocardiogram abnormal; Ejection fraction decreased; Intensive care; Intubation; Myocarditis; Pulmonary oedema; Respiratory distress	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~~3~IM~UN~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2460FA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0304373	02/05/2008	MN	41.0	41		F	01/31/2008	7 cm. round raised erythematous eruption around injection site & 2 cm. rash at site.									Y	01/24/2008	01/29/2008	5		PVT	OTH		None				1						1	Injection site erythema; Injection site rash	FLU3~SANOFI PASTEUR~U2441AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2869AA~1~UN~LA~TDAP (ADACEL)~1	USA		Influenza
0304383	02/05/2008		71.0	71		F	02/06/2008	We received on 24 JAN 2008 from a healthcare professional the following information: A 71-year-old female patient, born on 16 SEP 1936, was vaccinated i.m. with Fluvirin (batch no. unknown) on 09 OCT 2007. The patient experienced severe bruising on the extremities. It was reported that the patient experienced idiopathic thrombocytopenic purpura the last 2 years after vaccination (see cases MA2008-0090 and MA2008-0091). The outcome is unknown.									U	10/09/2007				OTH	OTH	No other medications	Unknown	Viral infection (viral illness between vaccination and occurrence of event); Idiopathic Thrombocytopenic Purpura		MA20080092	1						1	Contusion	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0304384	02/05/2008					F	02/06/2008	We received on 24 JAN 2008 from a healthcare professional the following information: A female patient, born on 16 SEP 1936, was vaccinated one year ago with an influenza virus vaccine (batch no. and manufacturer unknown) on an unknown date. The reporter believes that it was Fluvirin. The patient experienced idiopathic thrombocytopenia purpura. The outcome is unknown. She had a full workup by a hematologist with inconclusive results as to cause of ITP. It was reported that the patient also experienced idiopathic thrombocytopenic purpura 2 years ago after a flu vaccine (see case MA2008-0090) and severe bruising after this year's vaccination (MA2008-0092).									U					OTH	OTH	None	Unknown	Idiopathic Thrombocytopenic Purpura.  Adverse event 1 year ago after flu vaccination.		MA20080091	1						1	Contusion; Idiopathic thrombocytopenic purpura; Vaccine positive rechallenge	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0304385	02/05/2008					F	02/06/2008	We received on 24 JAN 2008 from a healthcare professional the following information: A female patient, born on 16 SEP 1936, was vaccinated, two years ago with an influenza virus vaccine (batch no. and manufacturer unknown) on an unknown date. The patient experienced idiopathic thrombocytopenic purpura. The outcome is unknown. It was also reported, that she experienced adverse events in the following two years (see cases MA2008-0091 and MA2008-0092).									U					OTH	OTH	No other medications	Unknown			MA20080090	1						1	Idiopathic thrombocytopenic purpura	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0304386	02/06/2008	OK	20.0	20		M	02/06/2008	Pt. began to see red bumps on his chest in a V-shape about 10 days after vaccination.  Member reported to clinic on day 11 with bumps on his back and arms as well.  No discharge, fever, or itching.  Reaction prevented member from deploying the next day.				Y					Y	01/05/2008	01/10/2008	5	Telederm and Viral Cultures Done	MIL	MIL	Vaccines were given on 6Jan08 as well:  Twinrix lot AHABB091CA and Typhoid VI lot Z0663-2.	None known	None known			1						1	Culture; Erythema; Rash	ANTH~EMERGENT BIOSOLUTIONS~FAV102~1~ID~RA~ANTHRAX (BIOTHRAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA063AA~2~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|SMALL~PFIZER\WYETH~4020076~1~OT~LA~SMALLPOX (DRYVAX)~1	USA	Emergency room visit	Influenza
0304390	02/06/2008	NY	55.0	55		F	02/06/2008	Patient called on 2/4/08 at 9am and spoke to writer regarding a flu vaccination she received on 11/06/07.  She informed writer she was currently having tingling and pain radiating up her R arm which was now proceeding down towards her right elbow.  She stated her symptoms began not long after receiving her flu vaccination in November with some localized tenderness and itching. She also reported having a black and blue mark at the injection site which has not gone away. She states her symptoms have become progressively worse with increased pain, and tingling.  She stated she has not reported nor seen her primary care physician regarding her signs and symptoms.  Writer recommended she call her primary care physicain for treatment and follow-up. Patient agreed to call her primary care physican and will follow up with writer after this assessment is completed.									U	11/06/2007	11/06/2007	0	none	UNK	UNK	Unknown	Unknown	Unknown			1						1	Injection site bruising; Pain in extremity; Paraesthesia; Pruritus; Tenderness	FLU3~SANOFI PASTEUR~U2057AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0304399	02/06/2008	MD	7.0	7		M	02/01/2008	SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 23 January 2008 from a health care professional.  A 7-year-old male patient, with no concurrent illnesses, and a history of allergies (allergies not defined) and asthma, had received a ninth, intramuscular, left arm dose of FLUZONE No Preservative 2007-2008 (lot number U2457HA) on 03 November 2007.  Eighty-one days after receiving the Fluzone vaccine, the patient developed a fever of 100.7 degrees Fahrenheit, watery eyes, congestion, cough, and sore throat.  A Quick Vue flu test positive for type A and B influenzae.  The patient was prescribed Tamiflu as treatment.  At the time of this report, the patient had not recovered.				Y					N	11/03/2007	01/23/2008	81	23/Jan/2008: Quick Vue flu test was positive for type A and B influenza.	UNK	UNK		The patient had no illnesses at the time of vaccination on 03 November 2007.	He did however, have a past medical history of allergies and asthma.		200800247	1						1	Cough; Influenza; Influenza serology positive; Lacrimation increased; Pharyngolaryngeal pain; Pyrexia; Respiratory tract congestion; Vaccination failure	FLU3~SANOFI PASTEUR~U2457HA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0304418	02/06/2008	MN	61.0	61		F	01/30/2008	She was immediately sick.  Very sick for 4 more days.  Kept getting worse.  Dec 20 put in hospital.  Dec 25 to ICU.  Dec 27 respirator.  Died 1/17/08.  2/21/08 Reviewed hospital medical records which included clinic visit & vax record of 11/28/07.  Database updated.  Patient w/palpitations intermittently when anxious or blood sugar low, 10# wt loss over past several months since the death of parent. H&P indicates patient experienced sinusitis, fever, chills, sore throat, nasal congestion, postnasal drip, swollen cervical lymph nodes & productive cough x 3 wks.  Dx w/bronchitis & pneumonia & tx w/oral antibiotics as outpatient w/o increasing fever, SOB & weakness.  Admitted 12/20/07-01/17/2008 w/community acquired pneumonia & dehydration.  Consults by pulmonogy, surgery & ID.  Conditioned worsened & was intubated & transferred to ICU.  Developed pneumothorax s/p transbronchial biopsy & had chest tube placed.  Developed acute ARDS & was trached 1/8/08. Continued to deteriorate & expired 1/17/2008. FINAL DX: none provided on D/C summary.  No autopsy done per med records.  Death certificate requested from funeral home. 2/21/08 Reviewed death certificate which states COD as respiratory failure with pneumonia as underlying cause.	Y	01/17/2008	Y		Y	30	Y		N	11/28/2007	11/28/2007	0	LABS: Admit CBC w/WBC 7/9 (N), H/H 11.2/32.7 (L), neutros 82.1% (H), lymphs 6.9% (L), eos 6.7 (H).  Admit Chem: Na 134 (L)CT chest scan revealed bilateral nodular lung inflitrates.  CT chest angio r/o pulmonary emboli.  Bronchoscopy revealed hemorrhagic secretions.  Transbronchial biopsy. Lung biopsy via thoracotomy revealed interstitial pneumonitis.  FANA (+) w/titer speckled pattern 1:160 (H).  Neut cyto aby IgG <1:20 (H).  EKG abnormal.  Echocardiogram abnormal w/RV dilation & dysfunction.	PVT	OTH		None	Many  PMH: depression & anxiety, under psychiatric care.  Type 2 DM; recurrent UTIs; hyperlipidemia; LBP w/multiple surgeries; thyroid disease; obesity; memory loss.  Hx of pneumonia.  Secondhand smoke exposure.  Family hx of DM & cardiac disease.  Allergy: Multiple meds including PCN, sulfa & vancomycin.			1						1	Death; Intensive care; Malaise; Mechanical ventilation	FLU3~SANOFI PASTEUR~AFLUA316AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0304420	02/06/2008	AZ	0.6	0	.6	M	02/01/2008	Baby threw-up all night day of administration.  Continued to vomit, did not retain any feeds.  Pt was taken to ER on the 20th.  No h/o excessive crying.  Temp T max 100.4.  Mom kept baby home.  He recovered in 1.5 days.  He had mild diarrhea also.									Y	12/20/2007	12/20/2007	0		PVT	PUB	nil					1						1	Body temperature increased; Diarrhoea; Food intolerance; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B071BA~1~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2477BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF213AA~1~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~AC21B071BA~1~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0304423	02/06/2008	CA	10.0	10		M	01/28/2008	Erythemic, edematous, warm left arm with 3 blisters (small).									U	01/25/2008	01/26/2008	1		PVT	UNK						1						1	Blister; Erythema; Oedema peripheral; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~02524A~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|VARCEL~MERCK & CO. INC.~1585U~1~UN~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0304427	02/06/2008	VA	1.3	1	.3	F	02/01/2008	Extensive limb (L) swelling.									Y	01/05/2008	01/06/2008	1		PVT	UNK		None	None			1						1	Injection site swelling	DTAPH~SANOFI PASTEUR~UF038AA~4~IM~LL~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~UR2456BA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~808674F~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0304434	02/06/2008	NV	0.53	0	.5	F	02/06/2008	The patient presented in the office on November 16, 2007 with vomiting, cramping abdominal pain.  She had not had a bowel movement for 2 days.  Her abd./gastro was soft and hypoactive.  She was diagnosed with viral gastroenteritis.   Pt. mom was told to supplement with Pedialyte 1/2 ounce every 15-20 minutes until the patient had not vomited for 6 hours.  She was told no solids for 24 hours and to give Mylicon drops every 4 hours as needed.  She was also told to go to the ER if it worsened over the weekend.  The patient then presented to the Emergency Room 11/18/2007 at 4:15 a.m. with worsening symptoms.  The ER did a KUB that showed nonspecific bowel gas pattern the ER physcian then consulted a General Surgeon who ordered an abdominal ultrasound.  The abdominal ultrasound was postive for intussusception localized in the right upper quadrant mainly pointing at an ileoceal or ileo-ascending colon intussusception.  The patient then underwent a hydrostatic barium enema reduction of her intussusception that failed.  So the patient was then transported to another facility where the intussuception was reduced.  2/7/08 vax rec received; no update needed- vax/lot # are as reported. 2/8/08 Reviewed ER medical records which reveal patient experienced abdominal pain & bilious vomiting x 3 days.  Transferred to higher level of care for peds surgical consult. 2/19/08 Reviewed hospital medical records which reveal patient experienced IS unable to reduce via BE at outlying hospital.  Had bilious emesis & abdominal pain 3 days prior to admit,  seen by pcp & dx w/recurrence of viral infection.  Resolved & recurred again & crying inconsolably.  Admitted 11/18-11/19/2007.  Surgical consult done.   FINAL DX: Intussusception, enema reduced.				Y	Y	2			Y	11/01/2007	11/15/2007	14	ER LABS: US of abdomen revealed ileoceal IS.  BE failed to reduce IS.  KUB WNL.  WBC 12.52 (H), plts 576 (H).  Urine w/3+ ketones, WBC 10-12 (H).  Hosp LABS: Repeat US revealed IS.  Gastrofraffin enema reduced IS.Plt count 499 (H).  Mono count 1.0 (H), CO2 19 (L).	UNK	UNK	None	None	None PMH: flu w/diarrhea which resolved after 3 days 2 wks prior to admit			1						1	Abdominal pain; Barium enema; Bowel movement irregularity; Gastroenteritis viral; Gastrointestinal sounds abnormal; Intussusception; Ultrasound abdomen abnormal; Urinary system X-ray	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B126BB~3~IM~RA~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2463AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B54007C~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1192U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0304443	02/06/2008	WA	83.0	83		M	12/12/2007	Hematoma secondary to flu shot on LVE.  Patient on coumarin therapy.  No obvious signs of infection.				Y					Y	12/02/2007	12/03/2007	1	Emergency room visit only	MIL	MIL	Coumarin; Numerous	None	Benin Prostatic Hypertrophy			1						1	Anticoagulant therapy; Haematoma	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0304449	02/06/2008	KS	45.0	45		F	02/06/2008	This case was reported by a healthcare professional and described the occurrence of coldness in a 45-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline). Concurrent medical conditions included asthma. Concurrent vaccination included Pneumovax (Merck) given on 26 October 2007. Concurrent medications included Nasacort, Astelin, Zyrtec, Singulair, Fluoxetine, Oral contraceptive (OCP), Advair 100/50 1 puff daily and then increased to 1 puff twice daily, Qvar, M.V.I, Maxair and Robitussin. On 26 October 2007 the subject received unspecified dose of Flulaval at 0.5 ml in the left arm. On 28 October 2007, 2 days after vaccination with Flulaval, the subject experienced coldness, spasms, numbness and decreased motor strength in her hand. The subject experienced a systemic reaction. The healthcare professional considered the events were disabling. At the time of reporting the events of coldness, spasms, numbness and decreased motor strength in her hand were improved. The healthcare professional considered these events were probably related to vaccination with Flulaval.								Y	N	10/26/2007	10/28/2007	2	The subject received a full work-up from a neurologist.  Specific tests performed and results were not reported.	PVT	PVT	Triamcinolone acetonide; Azelastine hydrochloride; Cetirizine hydrochloride; Montelukast sodium; Fluoxetine; Oral contraceptive; Fluticasone + salmeterol	Asthma	The subject has previously received flu shots with no documented reactions.  It was not known if the subject received Flulaval previously.  There were no documented reactions following previous vaccinations.		A0707560A	1						1	Asthenia; Feeling cold; Hypoaesthesia; Muscle spasms; Neurological examination	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA058AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1035F~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0304452	02/06/2008	AR	79.0	79		M	02/06/2008	Guillain Barre syndrome.  Received flu injection on 11-09-07 at health department about mid morning.  No symptoms during the day, but about 9:30pm on 11-11-07, became nauseated; went to bed.  By 4:00a.m. Sunday, 11-18-07, began having pain in legs (felt like needles pricking) and unable to stand.  Transported by ambulance to hospital.  Treated until Monday, 11-19-07, around 1:00pm, transferred to another hospital.  Admitted to ICU.  Dr. was admitting physician.  Remained in hospital until January 11, 2008.  Most of this time was in ICU, spent about a week in room before transferred.  Hospital admitted on January 11th, but later recommended transferring to rehabilitation center on January 14, 2008.  The plan is for the patient to have rehab locally until strong enough to go to another rehab for more aggressive rehab therapy.  Patient currently is taking therapy at rehab center.  At this time, he is currently unable to sit up, turn over, or walk.  4/11/08 Reviewed hospital medical records of 11/18-11/19/2007 & 11/19-1/11/2008. FINAL DX: Guillain-Barre, axonal type, slow progressive improvement; respiratory failure w/vent & tracheostomy; acute megacolon secondary to denervation requiring partial colectomy w/ileostomy & mucous fistula on 12/11/07; PEG feeding tube;  Records reveal patient experienced dizziness, nausea, numbness/tingling of hands & feet, acute bilateral weakness of LEs & balance disturbance which ascended progressively to include UEs w/n 24 hrs. Developed respiratory distress, heme occult (+) emesis, cardiac enzymes mildly elevated w/EKG WNL.  IVIG started & transferred to higher level of care ICU.  LP done.  Progressive ascending paralysis.  Tx w/plasmapheresis.  Extensive, complicated, lengthy stay in hospital & then transferred to swing bed prior to inpatient rehabilitation. Patient is at home having Home Health Services plus we have hired a personal CNA to care for him daily. He cannot sit up, turn over or walk. Has developed a severe tremor of right hand and some in left hand. This has interfered with his feeding himself. MD plans to add new med that will hopefully help with this new problem. We still do not know if he will progress to be able to walk again. I tried to obtain the lot number of injection, but was unable to get this info. from local Health Dept. Said they only used two lot numbers that day, but sent all records.  Follow-up: Can walk short distance with walker. Falls easily - balance problems. Can no longer drive automobile. Cannot dress himself - Needs daily caretaker to prepare meals. Assist bathing and dressing. Cannot walk up/down steps unless has a rail to hold to and someone to assist him. Uses wheel chair for long distance. Wright before GUILLAIN BARRE 207 - now 130 lbs. Requires depends-guards. Quality of life is gone. Husband was muscular - mowed grounds/trimmed shrubbery of chrines and our large home grounds. Has difficulty walking on grass even with a walker now. He carved duck decoys from wooden blocks and painted them. Jord and gave as gifts. No longer has enough control of hands and arms to do this. It is our feeling that he should be compensated for the Quality of life he lost and the expense of a daily caretaker and supplies used. If you need more information - please let us know.				Y	Y	58	Y	Y	N	11/09/2007	11/18/2007	9	Many lab tests were done inpatient - all negative for current symptoms.  LABS: CBC, chemistry, EKG, & CXR WNL.  CT of head & MRI brain WNL.  Abdominal x-ray abnormal. EMG/NCS abnormal & c/w GBS.  Initial WBC 15.7 (H) & chemistry essentially WNL.  CSF: protein peak 227 & glucose 96 (H), c/s neg..  ANA (+).	UNK	PUB	simvastatin, 40mg, 1 daily; atenolol, 25mg, a daily; clopidogrel (Plavix), 75mg, 1 daily; lisinopril, 10mg, 1 daily; aspirin, 81mg, 1 daily	None	Heart condition and high blood pressure  PMH: HTN, OA, CAD, CABG, angioplasty w/stents, hypercholesterolemia.  ALLERGIES: codeine, darvon.			1						1	Abasia; Abnormal loss of weight; Activities of daily living impaired; Balance disorder; Cardiac enzymes increased; Colectomy; Colonic fistula; Computerised tomogram head; Computerised tomogram normal; Culture negative; Dysstasia; Fall; Full blood count normal; Gastric occult blood positive; Gastrostomy tube insertion; Guillain-Barre syndrome; Hypoaesthesia; Immunoglobulin therapy; Incontinence; Intensive care; Muscular weakness; Nausea; Nerve injury; Pain; Pain in extremity; Posture abnormal; Respiratory distress; Tremor; Walking aid user; Wheelchair user; X-ray abnormal	FLU3~SANOFI PASTEUR~~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0304458	02/06/2008	NC	58.0	58		F	02/06/2008	Muscle soreness and weakness upon certain movements especially at night.  Extreme weakness in a week or so post injection for 4-5 days.  Has abated some but still limits movement.									N	11/14/2007	11/26/2007	12		OTH	PVT	None	None	None			1						1	Injected limb mobility decreased; Muscular weakness; Myalgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA298BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0304465	02/06/2008	GA	1.0	0	1	F	02/06/2008	High grade fever - Temperature at 104.6 F at 5:10 pm - decreased to 103.1 F in 10-15 mins.  Patient had afebrile seizure later that night - EMS called - taken to ER.  Postictal, no other abnormalities found.  Fever and vomiting started 02/05/08 daytime.				Y					Y	02/04/2008	02/05/2008	1	Urine culture done at ER - results pending.	PVT	PVT	None	None	None			1						1	Culture urine; Febrile convulsion; Postictal state; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U24819A~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A1188~3~IM~RL~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0304466	02/06/2008	VA	42.0	42		F	02/06/2008	No adverse events				Y					Y	01/31/2008	02/01/2008	1		PVT	PVT		None	Ultram; hyperthyroidism			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2441AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~02689AA~UNK~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0304471	02/06/2008	SC	43.0	43		F	01/29/2008	October 17, 2007 - Received flu shot in left arm.  Received pneumonia shot in right arm.  That evening, the injection site in my right arm was very red and the irritation was about the size of a quarter. October 18, 2007 - I woke up with a very small range of motion in my right arm without pain.  There was a orange size raised area around the injection area in the right arm.  I started having the chills.  About 1:00pm I was shaking with the chills.  I had 103.8 fever by 4pm.  I called clinic to let them know and I went to doctor.  The doctor took blood work for a CBC.  That was normal.  The raised red area had spread down and around my arm.  Still minimal range of motion without pain.  My muscles in my arm were burning.  The area was hard to the touch and hot.  The doctor concluded that my symptoms must be the result of the pneumonia inoculation.  That night my fever was 103.8-104 even though I was taking Tylenol and Motrin every 4 hours. October 19, 2007 - Irritation on my arm had spread further with pain moving down my muscles.  Fever 103.6 most of the day with 2 breaks of fever when it went down to +/-100.5 degrees.  Still very little range of motion in my arm without pain.  My arm was painful to the touch and was still raised and burning.  I tried warm compresses.  They did not help.  I was still taking Motrin and Tylenol. October 20, 2007 - Irritation on my arm was still spreading, still raised and hard.  I still had little range of motion.  My temperature was 103 in the morning and in the late afternoon.  Otherwise my temp was about 100. October 21, 2007 - Irritation on my arm looked better, some swelling had gone away.  My range of motion was increasing.  Still painful to the touch and there was a burning sensation in my muscles.  I woke up with no temperature but it went up to about 100.6 late in the afternoon.  My temp went back down after Tylenol.  My chest started feeling a little tight.  Started with a dry cough. October 22, 2007 - The raised irritation is gone on my arm.  Range of motion is almost normal.  There is a burning sensation in my muscles of my arm but the area is no longer hard and hot.  I had no fever.  I had to take some old asthma medication because of the tightness in my chest.  Blisters in mouth.										10/17/2007	10/17/2007	0		OTH	PVT						1						1	Burning sensation; Chest discomfort; Chills; Cough; Erythema; Injected limb mobility decreased; Injection site erythema; Injection site induration; Injection site irritation; Injection site swelling; Myalgia; Oral mucosal blistering; Pyrexia; Skin warm; Tremor; Abasia; Injected limb mobility decreased; Pain; Pain in extremity; Parvovirus B19 serology positive; Parvovirus infection; Pyrexia	FLU3~SANOFI PASTEUR~U2492AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0038U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U2492AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0038U~2~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0304473	02/06/2008	VA	80.0	80		M	01/14/2008	Patient reports waking up on 1/11/08 around 1 AM with symptoms of fever, chills, asthma or difficulty breathing, increased heart rate.  Symptoms resolved without patient seeking medical advise.  Patient does not complain of lasting adverse effects.									Y	01/10/2008	01/11/2008	1		OTH	PVT		None	Unknown			1						1	Asthma; Chills; Dyspnoea; Heart rate increased; Pyrexia	FLU3~SANOFI PASTEUR~U2465AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0304474	02/06/2008	MI	71.0	71		F	01/30/2008	Prickly sensation right side of face-lasted 45min-1 hour.  Started after vaccine given-while waiting 20min after vaccine given.									Y	11/09/2007	11/09/2007	0		PVT	PVT	Prilosec; Zetia	None	Allergies Demerol, PCN; high cholesterol; GERD			1						1	Paraesthesia	FLU3~SANOFI PASTEUR~U25018A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~0966U~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0304476	02/06/2008	MA	9.0	9		M	02/01/2008	L arm with swelling & redness 12.5 cm x 14.5 cm around site of Varivax injection.				Y					U	01/29/2008	01/31/2008	2		PUB	UNK		Mild URI				1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2513AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1515U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0304479	02/06/2008	NY	22.0	22		F	02/06/2008	Significant local reaction at injection site with significant redness, warmth, slight swelling & soreness for 2 days.									Y	02/04/2008	02/04/2008	0		OTH	OTH	None	None	None			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Local reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80435~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0061U~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0304480	02/06/2008	NY	23.0	23		F	02/06/2008	Significant local reaction at injection site with significant redness, warmth & pain for 2-3 days.									Y	10/30/2007	10/31/2007	1	None	OTH	OTH		None	None			1						1	Injection site erythema; Injection site pain; Injection site warmth; Local reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80435~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0380U~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0304481	02/06/2008	VA	32.0	32		M	11/26/2007	4 diameter, red raised itchy hive to injection shot.  Appeared approximately 36 hours after shot.  No treatment.  Symptoms gone in 48 hours.									Y	11/15/2007	11/17/2007	2	None	OTH	OTH	None	None				1						1	Injection site pruritus; Injection site urticaria	FLU3~SANOFI PASTEUR~B5731~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0304503	02/07/2008		66.0			F	02/06/2008	Information has been received from a physician's assistant concerning a 66 year old female with high cholesterol and no drug allergies who on 17-DEC-2007 was vaccinated SC with one dose of Zostavax (Oka/Merck). Concomitant vaccination administered on that same day included a dose of influenza virus vaccine (unspecified). On approximately 18-DEC-2007 24 to 48 hours after vaccination, the patient experienced mild hoarseness in her voice and mild itching on her chest. Both symptoms resolved within a day or two on approximately 20-DEC-2007. On 27-DEC-2007 the patient woke up with severe bilateral ear pain. Upon examination at the physician's office she was found to have red ear drums. The patient was treated with an antibiotic for a suspected ear infection. The patient's ear pain continued and her hearing became worse. On approximately 31-DEC-2007 2 weeks after vaccination, the patient went to a specialist for a hearing test which showed moderate to severe nerve damage. The physician thought the event was due to a viral infection and treated the patient with FAMVIR and a steroid. On 28-JAN-2008 the patient had a repeat hearing test which showed mild improvements even though the patient still had trouble hearing other people. The patient was noted to be recovering. There was no product quality complaint. Hearing loss was considered to be disabling by the reporter. Additional information has been requested.				Y				Y	N	12/17/2007	12/18/2007	1	hearing test 01/28/08 mild improvements; hearing test 12/31/07 moderate to severe nerve damage; physical examination 12/27/07 red ear drums	OTH	OTH		Cholesterol high			WAES0802USA00460	1						1	Acoustic stimulation tests abnormal; Deafness; Deafness bilateral; Dysphonia; Ear disorder; Ear infection; Ear pain; Erythema; Nerve injury; Pruritus; Viral infection	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Disabling	Influenza
0304507	02/07/2008	PA	8.0	8		M	02/07/2008	Large area of swelling and redness surrounding and extending injection site.									Y	01/31/2008	02/02/2008	2	None	PVT	PUB	albuterol inhaler as needed	None	NKA			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2439AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1368U~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0304522	02/07/2008	OH	51.0	51		F	02/07/2008	L arm SQ area above elbow from pneumonia shot on Wednesday afternoon- by Thursday morning area became sore - swollen to the size of a quarter -reddened - had violent shivering episodes - Friday at dinnertime noticed it was getting bigger-shivering continued - had trouble moving her arm due to the pain - took Motrin and Darvocet but did not take away pain.  Saturday morning awoke and went directly to the ER approx. 11am - the hospital completed blood work - Pt stated she was told she had an infection - a CT scan was completed and IV pain medication was started - CT scan showed no abscess - started on IV antibiotics - was not admitted - Given Vicodin and a PO antibiotic - Was unable to sleep because of pain. Sunday she called her family physician and stated it was worse - PCP told her to go to hospital for admission immediately. Pt was in hospital for 4 days on IV antibiotics and pain medications - diagnosed with cellulitis.  Released to home on Wednesday evening with Vicodin and Bactrim BID. Swelling has decreased - pain has decreased a little - Will follow up with physician tomorrow. 2/8/08-records received for DOS 2/3-2/06/08-Presented to ED with C/O left arm pain and swelling, pain in left hand. PE: left upper extremity erythema and duration located in triceps region, minimal fluctuance with discomfort on palpation. DX: Left upper extremity cellulitis.				Y	Y	3			Y	01/30/2008	01/31/2008	1	2/8/08-records received-CBC unremarkable with slightly elevated WBC 13,000. CT scan no evidence of abscess.	UNK	UNK	Lisinopril, Crestor, Synthroid, aspirin, Lamictal, Trazadone, Glucophage, Protonix	None	Allergies: Levaquin  Medical Conditions: Heart Disease, Acid Reflux, Hypothryroidism, Diabetic, Insomnia, Bipolar 2/8/08-records received-PMH: Diabetes mellitus, coronary artery disease, bipolar disorder, hyperlipidemia, gastroesophageal reflux disease, hypothyroidism, asthma.			1						1	Chills; Computerised tomogram normal; Injected limb mobility decreased; Injection site erythema; Injection site swelling; Insomnia; Pain in extremity	FLU3~SANOFI PASTEUR~U2527AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0554U~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0304538	02/07/2008	CA	6.0	6		M	02/07/2008	Developed swelling of face, hands and feet the following morning, along with hives all over the body. Was taken to the emergency room and given a prescription for 5 days of prednisone and Benadryl to use as needed for swelling.				Y					Y	02/04/2008	02/05/2008	1		UNK	UNK	albuterol	viral upper respiratory illness	asthma			1						1	Oedema peripheral; Swelling face; Urticaria	FLU3~SANOFI PASTEUR~U2516AA~5~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0747U~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1764U~2~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0304539	02/07/2008	TX	2.0	2	.5	F	02/07/2008	Patient was inadvertently given Tdap.  Patient is 2 Years old.									Y	02/07/2008				UNK	UNK	None	None	None			1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~UT2477DA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB211AA~1~IM~LL~HEP A (HAVRIX)~1|TDAP~SANOFI PASTEUR~C2758AA~1~IM~RL~TDAP (ADACEL)~1	USA		Influenza
0304547	02/07/2008	PA	15.0	15		F	02/06/2008	12/16/07 - PM - injection site left arm became red, increased over next couple days to about 2 inches in diameter.  Seen in doctor's office 12/20/07.  Redness had started to fade by then, and completely resolved by 12/28/07.				Y					Y	12/14/2007	12/16/2007	2		PVT	PVT						1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U2531AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1258U~2~IM~RA~HEP A (VAQTA)~1|HPV4~MERCK & CO. INC.~1522U~3~IM~LA~HPV (GARDASIL)~1|VARCEL~MERCK & CO. INC.~1257U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0304548	02/07/2008	AR	5.0	5		M	02/07/2008	Patient brought into clinic on 2/7/08 with red, swollen, hot to touch LA. LA approx. 12cm x 8cm. 2/7/08									U	02/05/2008	02/07/2008	2	none	PUB	OTH	None	none				1						1	Erythema; Oedema peripheral; Skin warm	DTAP~SANOFI PASTEUR~U2290AA~5~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2514AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB225BC~1~IM~RA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~Z1009~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1308U~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1761U~3~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0304135	02/08/2008	IL	53.0	53		M	02/03/2008	Chronic pain radiating from injection site, starting several days after shot causing discomfort day and night, lasting 3 months plus.				Y					N	11/02/2007	11/05/2007	3		OTH	OTH	None	None	Tinnitus			1						2	Pain in extremity; Injection site pain; Pain	FLU3~SANOFI PASTEUR~U2514AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2514AA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0304575	02/08/2008	CA	62.0	62		M	02/08/2008	Lab results drawn 11.13.07 (day after vaccine given) showed critical values: WBC 2.6. Pathologist reviewed = leukopenia. Patient had stopped Simvastin 3 weeks prior but was taking Diazide (which has known although rare instances of leukopenia). Stopped Diazide 11.13.07, repeat lab 11.14.07 showed normalized WBC.									Y	11/12/2007	11/13/2007	1	see above lab result (WBC)	UNK	UNK	VYTORIN, VITAMIN B12, TAMSULOSIN, ATENOLOL, DYAZIDE (STOPPED 11.13.07), PLAVIX, ASPIRIN, MULTIVITAMIN.	FATIGUE, POLYNEUROPATHY	RENAL CELL CARCINOMA, HYPERTENSION, HYPERTROPHY (BENIGN) PROSTATE, IMPOTENCE (ORGANIC), LIPIDOSIS, NEUTROPENIA, HEARING LOSS (NOISE INDUCED), S/P PERCUTANIOUS TRANSLUMINAL CORONARY ANGIOPLASTY, SPLENOMEGALY, ANEMIA. Allergies ACE Inhibitors; LIPITOR			1						1	Leukopenia; White blood cell count decreased	FLU3~SANOFI PASTEUR~undocumented~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0304576	02/08/2008	CA	65.0	65		F	02/08/2008	Vaccine given 11.5.07; by 11.5.07 night patient experiened shaking legs; she thinks she developed a fever; staying in bed all day Tues and Wed. Wed. night legs calmed down. There was swelling, redness and pain at injection site which showed improvement by 11.8.07 when she came in for appointment.									Y	11/05/2007	11/05/2007	0	none	UNK	UNK	HYDROCHLOROTHIAZIDE; SOMA; ACIPHEX; LOTREL; VYTORIN; EFFEXOR; ALPRAZOLAM; NORCO; TRAZODONE; MULTIVITAMIN	NO ACUTE ILLNESS; CAME IN FOR FOLLOW UP ON CHRONIC MEDICAL PROBLEMS (SEE #19)	HYPOTHYROIDISM (ACQUIRED); CATARACT; CHRONIC LOW BACK PAIN; HYPERTENSION; HYPERCHOLESTEROLEMIA; DEPRESSION; GERD; ALLERGIC TO TALWIN.			1						1	Hypersomnia; Injection site erythema; Injection site pain; Injection site swelling; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U2436AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~undocumented~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0304588	02/08/2008		2.0			M	02/04/2008	Seriousness: Other-Medically Significant Information received on 24 January 2008 from the above reference journal article in which a 2-year-old male patient had received their first Influenza vaccine (manufacturer and lot number not provided) and shortly thereafter, developed a few hives scattered on his body with no respiratory symptoms. The hives appeared intermittently and were treated occasionally with diphenhydramine. The patient subsequently received his Influenza booster vaccination one month later and within ten minutes of vaccination, starting having coughing, wheezing and hives all over his body. he was treated acutely with diphenhydramine and nebulized albuterol. Epinephrine was not given. The patient was referred for evaluation of his allergic reaction to influenza vaccine. His physician examination at the time of follow-up for an allergy evaluation was normal. The patient had no known allergies and was up to date with their vaccinations with no prior adverse events. The patient had a positive history for developing perioral hives associated with eating gummy candy fruit snacks and Hot Tamale candies. The patient had been able to eat eggs with no problems. Follow up allergy testing included a skin prick test with the following results: histamine 6/30 mm, saline 0/0 mm, Knox gelatin (mixed with saline) 3/15, and liquefied gummy fruit snack (1:1 dilution in saline) 6/25 mm. Serum was sent for IgE to specific antigens with the following results: 1g# 127 ku/L with RAST to bovine gelatin 4.50 (class 3). A diagnosis of gelatin allergy was concluded based on his history and confirmatory skin and RAST testing. Since his initial episode, the patient had inadvertant gelatin exposure with ingestion of Frosted Mini-Wheat cereal, bacon and lunch meats with subsequent allergic reactions. No further information was provided in the report.				Y					Y				Skin Prick test: histamine 6/30 mm, saline 0/0 mm, knox gelatin (mixed with saline) 3/15, liquefied gummy fruit snack (1:1 dilution in saline) 6/25 mm. Serum IgE to specific antigens: Ig# 127 ku/L with RAST to bovine gelatin 4.50 (class 3).	UNK	UNK			The patient had no known allergies and was up to date with their vaccinations with no prior adverse events. The patient had a positive history for developing perioral hives associated with eating gummy candy fruit snacks and Hot Tamale candies		200800271	1						1	Allergy test positive; Blood immunoglobulin E; Cough; Food allergy; Hypersensitivity; Radioallergosorbent test; Similar reaction on previous exposure to drug; Urticaria; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0304593	02/08/2008	CA	0.6	0	.6	F	02/04/2008	Fever, chills, vomiting, no coughing.									Y	01/29/2008			N/A	PUB	OTH	N/A	None	None			1						1	Chills; Inappropriate schedule of drug administration; Pyrexia; Vomiting	DTAP~UNKNOWN MANUFACTURER~~3~UN~UN~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~4~UN~UN~HEP B (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~3~UN~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~3~UN~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0304595	02/08/2008	AZ	1.4	1	.4	M	02/01/2008	Mild Immz. reaction to R upper thigh									Y	01/30/2008	02/01/2008	2		PVT	OTH				Swelling~DTaP (no brand name)~5~1.00~In Patient		1						1	Immunisation reaction	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B062AA~5~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2481EA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0304600	02/08/2008	CO	3.0			F	02/01/2008	Leg pain to feet since vaccination														PUB	UNK	None	None	NKDA			1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2436AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB21~2~~RL~HEP A (HAVRIX)~1	USA		Influenza
0304604	02/08/2008	NJ	32.0	32		F	02/06/2008	R arm-localized reaction.  Rx: Medrol Dose Pak, ice, Omnicef.									Y	02/04/2008	02/05/2008	1		PVT	PVT	Zoloft; Wellbutrin	No				1						1	Local reaction	FLU3~SANOFI PASTEUR~U2507AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0304611	02/08/2008	OH	58.0	58		M	02/08/2008	PT. RECIEVED INFLUENZA VACCINATION 12 JAN 08. NOTICED ON 29 JAN 08 THAT THERE WAS A QUARTER SIZED INDENTATION AT THE SITE OF THE IMMUNIZATION, NO PAIN SWELLING, SOME REDNESS.									U	01/12/2008	01/29/2008	17		MIL	MIL		N/A	N/A			1						1	Injection site atrophy; Injection site erythema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA025AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0304625	02/08/2008	WI	13.0	13		F	02/08/2008	Redness, swelling, warmth, & tenderness L upper arm.				Y					Y	02/06/2008	02/07/2008	1		PVT	PVT	None			unknown~Varicella (Varivax)~UN~5.00~In Patient		1						1	Erythema; Oedema peripheral; Skin warm; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80682~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|MNQ~SANOFI PASTEUR~U2181AA~UNK~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B0154AA~6~IM~RA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1584U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0304630	02/08/2008	CO	4.0	4		M	02/07/2008	Pt received Fluzone on 11-21-07. Started developing hair loss about 1 week later. Now with alopecia universalis.									N	11/21/2007	11/28/2007	7	CBC 12-5-07; H/H 13.0/37.5; Plts 261K; WBC 5.4 with N 26, L 55, M 6, E 12	PVT	OTH	None	None	Atopic dermatitis			1						1	Alopecia universalis; Eosinophil count increased; Full blood count; Haematocrit normal; Haemoglobin normal; Lymphocyte count increased; Monocyte count normal; Neutrophil count decreased; Platelet count normal	FLU3~SANOFI PASTEUR~U2443AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0304631	02/08/2008	GA	29.0	29		F	02/08/2008	Left deltoid hot to touch, very tender, swollen, red.  Swelling & redness measures approximately 3 1/2 X 4 1:00pm when client came to clinic.  Called and made appointment with Dr. at 1:30pm today for evaluation & treatment if needed.				Y					U	02/05/2008	02/06/2008	1		PUB	OTH			Connective tissue disease			1						1	Erythema; Oedema peripheral; Skin warm; Tenderness	FLU3~SANOFI PASTEUR~U2509AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0989U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0304632	02/08/2008	CA	45.0	45		M	02/08/2008	Pts wife called on 2/7 reported (L) arm red, swollen and painful. Temperature of 102 on 2-5 and 2-6. Pt had hives as well. On 2/7 all symptoms resolved with exception of tenderness in arm.									Y	02/04/2008	02/05/2008	1		PUB	UNK		Sore throat	None			1						1	Body temperature increased; Erythema; Oedema peripheral; Pain in extremity; Tenderness; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA305BA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB412AA~1~UN~RA~HEP B (ENGERIX-B)~1|PPV~MERCK & CO. INC.~0961U~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0304616	02/09/2008	PA	41.0	41		M	02/09/2008	Headaches for 2 weeks tired for 2 weeks sinus congestion for 2 weeks left side of throat sore month.									Y	01/05/2008	01/06/2008	1		MIL	MIL	N/A	none	N/A			1						1	Fatigue; Headache; Oral pain; Pharyngolaryngeal pain; Sinus congestion	FLUN3~MEDIMMUNE VACCINES, INC.~500502P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~UNKNOWN MANUFACTURER~1054U~2~IM~UN~HEP A + HEP B (NO BRAND NAME)~1	USA		Influenza
0304618	02/09/2008	MO	47.0	47		F	02/09/2008	Had vaccine at 4:15 pm on 02/05/08. Slept poorly, woke up Wednesday feeling anxious. Went to work felt like my blood pressure was really high (no ongoing history of high blood pressure) heart periodically raced throughout the day. Started getting a headache. Left work at noon. Took blood pressure at home - 120/85. Rested in afternoon. Headache came off and on for the rest of the day. Went to bed early and got up feeling fine on Thursday. Didn't occur to me to read the information sheet to connect symptoms to shot.									Y	02/05/2008	02/06/2008	1		UNK	UNK						1						1	Anxiety; Headache; Palpitations; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0304670	02/11/2008	NY	2.0	2	.5	F	02/07/2008	Flu shot given around 10:45am 2-6-08.  Cried with shot - continued to cry for 4 hours.  Tried Tylenol and cold pack to leg.  No redness or swelling noted.  Child started complaining of head hurting.  No temperature.  Re-examined child at 1555.									Y	02/06/2008	02/06/2008	0		PVT	PUB						1						1	Crying; Headache	FLU3~SANOFI PASTEUR~U2461A~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0304675	02/11/2008	CT	53.0	53		F	02/05/2008	Patient seen in office for right arm pain, onset at time of injection 12-20-07. Pain continued to date of 1/25/08. Right deltoid tender to palp. No heat, Rubur or swelling.									Y	12/20/2007	12/20/2007	0		PVT	UNK		Breast Reconstruct. surgery				1						1	Immediate post-injection reaction; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA311BA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0304677	02/11/2008	FL	72.0	72		F	02/05/2008	Extreme pain or weakness in arm, leg, buttock muscles. Pain worsens at night - ongoing for 2 months with periods of low grade fever, aches flu-like symptoms				Y					U	11/10/2007	12/04/2007	24	CBC normal, nasal swab flu germ test negative on Feb 1, '08	OTH	PVT	none	none	none			1						1	Full blood count normal; Influenza like illness; Influenza serology negative; Muscular weakness; Musculoskeletal pain; Pain; Pain in extremity; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78995~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0304678	02/11/2008	IL	22.0			M	02/05/2008	2-5-08. 1:30pm Call from patient saying he is itching all over since he started taking Oral Typhoid. He took 1 pill on 1/30, 2/1, and 2/3. Says he has no visible rash today but he did have last night. Recommended to contact his physician how and to not take any further medicine until he consults with Dr. He said he didn't want to contact his Dr. I again stressed the importance of not continuing his medication and contacting hid Dr.									U					PUB	PVT		None				1						1	Pruritus generalised; Rash	FLU3~SANOFI PASTEUR~U2486AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~BERNA BIOTECH, LTD.~3001291~UNK~PO~MO~TYPHOID LIVE ORAL TY21A (VIVOTIF)~1	USA		Influenza
0304682	02/11/2008	OH	1.1	1	.1	M	02/06/2008	Immunizations were given at 11:00AM.  By 4:00-5:00PM pt had a fever (temp not taken).  Pt had a febrile seizure.  Parents called 911.  Pt taken to ER.  Temp was 104 degrees.  UA was neg.  Dx: febrile seizure.  Parents instructed to give Motrin before and after pt. receives shots in the future.  Fever gone after 24 hours.				Y					Y	02/04/2008	02/04/2008	0	UA-negative	PUB	PUB		No	No			1						1	Febrile convulsion; Pyrexia; Urine analysis normal	FLU3~SANOFI PASTEUR~UT2477FA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB200AA~1~IM~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0808U~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1659U~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0304686	02/11/2008	OH	66.0	66		F	01/21/2008	Patient received immunizations for Influenza and Pneumonia at the same time at different sites on 10/14/2007. Shortly after receiving them, patient described that she had a headache and then noticed increased numbness/tingling in her hands and feet with difficulty swallowing for a week prior to admission.Patient was admitted to Medical Center, on 10/21/2007 with headache, gait disorder, weakness, balance problems, facial weakness and ataxia and was diagnosed with Guillain-Barre Syndrome Miller Fisher variant secondary to immunizations. She was transferred to a rehab center on 12/10/2007 but still is experiencing numbness in her hands and feet. 3/27/08-records received for DOS 10/21-10/30-07-DC DX:Miller Fisher Guillain Barre syndrome. Dysphagia. Admitted with C/O fascial numbness, difficulty swallowing, slurred speech, weakness and ataxia. RX with IVIG, transferred to rehab facility, at time of DC continued to have significant issues with dysphagia.					Y	9			U	10/14/2007	10/21/2007	7	3/27/08-records received- EEg normal. MRI/MRA mild to moderate ischemia. MRI spine, signal abnormality lumbar spine. Lumbar puncture no acute abnormality. Culture no growth.	UNK	UNK			Her past medical history is positive for peripheral neuropathy and dysphagia but is negative for GBS. Patient didn't recall the last time getting the Influenza vaccine or if she ever had. Only allergy patient listed was a silk tape allergy. 3/27/08-records received-PMH:Bell's palsy, endometriosis. Facial surgery after automobile accident.			1						1	Asthenia; Ataxia; Balance disorder; Dysphagia; Facial paresis; Gait disturbance; Guillain-Barre syndrome; Headache; Hypoaesthesia; Miller Fisher syndrome; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0304690	02/11/2008	VA	11.0	11		M	02/11/2008	My son was given the inactive vaccine and within 10 minutes his arm had red patches, swelling, and a fair amount of discomfort. This patches and swelling continued to spread up his arm. Since we were still in the clinic, we went back to the administering nurse. We then saw the doctor, who then put a prescription for Benadryl in the computer. We walked to the pharmacy (onsite) and were helped right away (per the doctor's orders), and administered the Benadryl. Within an hour or two, the adverse reaction disappeared. Time of vaccination is actual appointment time, so the time the vaccination was administered was probably closer to 10:30.									Y	11/12/2007	11/12/2007	0		MIL	UNK	Singulair/Flovent and albuterol inhalers as needed.	none	Reactive Airway Disease (minor/seasonal)			1						1	Erythema; Oedema peripheral; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0304693	02/11/2008	KS	51.0	51		F	02/11/2008	Within ten minutes of receiving the shot, I felt a sensation travel up my arm, shoulder and neck until it stopped in my right jaw area, and felt like novocaine kicking in. I have since had roving tingling, numb-ish sensation, and pain on both sides of my face and throughout my mouth, tingling in my legs, severe muscle tension in my neck, chills and fever, and dizziness. I have seen several doctors but no one has been of any help. I am trying alternative therapies and have have some improvement of symptoms.				Y					N	11/30/2007	11/30/2007	0	neurological examination	UNK	UNK	none at time	none	Mold, cat and dog dander, penicillin, Dilantin. Have spots in my brain which show up on MRI's but they are of unknown cause.			1						1	Chills; Dizziness; Facial pain; Hypoaesthesia; Hypoaesthesia facial; Hypoaesthesia oral; Muscle tightness; Neurological examination; Oral pain; Paraesthesia; Paraesthesia oral; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80822~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0304694	02/11/2008	CA	58.0	58		F	02/11/2008	Pain in left arm lasted for over 1 month feeling like shot was just given.  Then progressed to shooting pains in left arm, numbness and pins and needles in arm and face on left side. Wake at night with left upper arm pain and left hand asleep.  Now feeling some pins and needles in left lower leg also.  Shoulder is frozen decreased range of motion.  Dr. took x-ray and it looked normal.  Prescribed Gabapentin, 100 mg 3 x a day.  No relief from medication.  Have been referred to physical therapy for loss of range of motion.  Have not had first appointment yet.				Y					N	09/27/2007	09/27/2007	0	To date only xray of left shoulder and upper arm.	UNK	UNK	none	none	penicillin			1						1	Hypoaesthesia; Hypoaesthesia facial; Joint range of motion decreased; Pain; Pain in extremity; Paraesthesia; Periarthritis; X-ray limb	FLU3~SANOFI PASTEUR~U2453AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0304696	02/11/2008	CA	3.0	3		F	02/11/2008	Fever for 7 days up to 102.5 degrees F. Fussy and tired for two days, but now with normal activity. Only constant fevers, especially at night.									U	02/05/2008	02/05/2008	0		UNK	UNK	Pediacare, Albuterol	Upper respiratory infection	Asthma, allergic rhinitis, eczema			1						1	Fatigue; Irritability; Pyrexia	FLU3~SANOFI PASTEUR~U2454AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0304711	02/11/2008	LA	58.0	58		F	02/01/2008	01/25/08 11:00 PM Couldn't breathe or talk at fist. Then c/o pain in chest - then all over. 11:06 Ambulance called. 11:35 Ambulance arrived. Transported to hospital. 09/08 Had problems with SOB to ER - Test did not show anything (info given by daughter). 2/12 /08-myocardial infarction per coroner's office.  no autopsy performed.   4/7/08-ER records received for DOS 1/26/08-cardiac arrest. Prounced 0054.	Y	01/26/2008							N	01/25/2008	01/25/2008	0		PUB	PUB	Hormones; High BP Pills				LA080203	1						1	Chest pain; Dyspnoea; Pain; Speech disorder	FLU3~SANOFI PASTEUR~U2514AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0304714	02/11/2008	AZ	35.0	35		F	02/11/2008	Onset 4-6 hours after vaccination with pain, redness, swelling to R upper arm injection site. Pt then developed fever 100 degrees on Saturday up to 101 degrees on Sunday with generalized malaise, shortness of breath, & extreme fatigue.  Pt states had pneumonia vaccine in past with no reaction.									U	02/09/2008	02/09/2008	0	None	PUB	UNK			Hx ventricular tachycardia - s/p ablation; pt states had pneumonia vaccine in past with no reaction.			1						1	Dyspnoea; Fatigue; Injection site erythema; Injection site pain; Injection site swelling; Malaise; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~1539V~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~AFLVA318CA~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0304717	02/11/2008	MO	15.0	15		F	02/11/2008	Seen ER report dated 2-7-08 22:21 and returned to ER 2-8-08 00:13.  Hospital Mon.				Y					Y	02/06/2008	02/07/2008	1		OTH	OTH			Asthma			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~62435AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0928U~2~IM~LA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0304727	02/11/2008	TX	37.0	37		F	01/28/2008	Swelling in Left Arm - Ibuprofen 400mg three times a day for 10 days.				Y					Y	12/14/2007	12/14/2007	0		OTH	PVT						1						1	Oedema peripheral	FLU3~SANOFI PASTEUR~U2450AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0304730	02/11/2008	FL	1.0	1	.0	M	02/01/2008	Seen 1 day after MMR given. Fever for 2 days, History of parotid swelling 1/31, scrotal swelling for 2 days. Possible reaction of fever, parotitis, orchitis. Sent to ER.. Mumps IgM/G and mumps culture -> urine pending.				Y					U	01/23/2008	01/31/2008	8	See above. Also scrotal US in E.R. All results pending.	PUB	PUB	none; tylenol after vaccine	None	None			1						1	Culture urine; Mumps antibody test; Orchitis; Parotid gland enlargement; Parotitis; Pyrexia; Scrotal swelling; Ultrasound scan	DTAP~SANOFI PASTEUR~U2290BA~4~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2474BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0494U~1~IM~LA~HEP A (VAQTA)~1|MMR~MERCK & CO. INC.~0809U~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1462U~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0300085	02/12/2008	TX	0.48	0	.5	M	01/23/2008	My son suffered from intussuseption after taking the 3rd (6 month) dose of Rotateq.  He began vomiting the evening of Nov. 25.  He vomited all night long, the morning of the 26th I took him to his doctor.  He had been vomiting blood and was dehydrated, so the pediatrician recommended we hospitalize him.  He was admitted to the hospital about 4 in the afternoon on the 26th.  The doctor thought he had a stomach virus, so blood tests and cultures were taken and he was given IV fluids.  They also collected urine to culture.  His condition deteriorated over the 27th, he continued to vomit blood.  After passing a few spots of blood from his rectum, (on the 27th) we began to suspect something more serious (an x-ray (upon admittance) of his stomach had been clear).  After having some problems with the nurses, (who told me he was throwing up mucus, not blood - and he was going to be just fine).  I got administration involved because I was afraid for my child's life at this point.  They got his pediatrician up there at 4 am on the 28th, when he passed a bloody - mucousy stool.  This finally signaled to the doctor intussuseption.  He was transported to another hospital by ambulance about 8 am on the 28th.  We were admitted through the ER.  They started a new IV because the original one had come partially out.  He was seen by a pediatrician.  He was then given an ultrasound, which showed the place where his intestines had telescoped themselves.  He was given a barium enema, while a surgical team stood by in case it didn't work.  It took 7 barium enemas to release it.  When it did release, it sent a lot of bad bacteria that had been trapped.  This caused his color to turn gray-mottled, his breaths to come short and fast.  They rushed him to the PICU, where he (thankfully) quickly stabilized.  His fever came down and he began to move around more and not act so listless.  The next morning, the 29th, he was released to a regular room, and released from the hospital later that day, about 5pm the 29th.  After being home a few hours, he became very fussy and inconsolable, not wanting to breast feed, which concerned me.  Not wanting to take any risks, I called and talked to the nurses on the aftercare hotline.  They talked to the doctors, who said to bring him in.  So we were once again admitted to the hospital through the ER.  An ultrasound and x-ray were done and showed no problems.  We were kept overnight for observation and released again about 12pm on the 30th.  We had follow up appointments the next week with his pediatrician and the head of the surgical team that oversaw my son's care (even though he didn't need surgery) at the hospital.  He has since fully recovered and is now 9 months old and wonderfully healthy.			Y	Y	Y	5			Y	11/14/2007	11/25/2007	11	X-rays, ultrasound, blood tests, urine culture, stool culture, blood culture.	PVT	OTH	None	None	None			1						3	Bacterial infection; Barium enema; Dehydration; Haematochezia; Hypoventilation; Intensive care; Intussusception; Listless; Livedo reticularis; Mucous stools; Pallor; Shock; Skin discolouration; Ultrasound scan abnormal; Vomiting; X-ray; Barium enema; Blood culture; Blood test; Crying; Culture stool; Culture urine; Dehydration; Diet refusal; Haematemesis; Haematochezia; Intensive care; Intussusception; Irritability; Livedo reticularis; Mucous stools; Pyrexia; Respiratory rate increased; Ultrasound scan; Vomiting; X-ray	DTAP~SANOFI PASTEUR~C2607AA~3~UN~UN~DTAP (TRIPEDIA)~2|FLU3~SANOFI PASTEUR~UT2460EA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~SANOFI PASTEUR~UF192AA~3~UN~UN~HIB (ACTHIB)~2|PNC~PFIZER\WYETH~B087028~3~UN~UN~PNEUMO (PREVNAR)~2|RV5~MERCK & CO. INC.~1460U~3~PO~MO~ROTAVIRUS (ROTATEQ)~2|DTAP~SANOFI PASTEUR~C2607AA~3~UN~LL~DTAP (DAPTACEL)~3|FLU3~SANOFI PASTEUR~UT2460BA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~3|HIBV~SANOFI PASTEUR~UF192AA~3~UN~RL~HIB (ACTHIB)~3|PNC~PFIZER\WYETH~B087028~3~UN~LL~PNEUMO (PREVNAR)~3	USA	Life Threatening,Hospitalisation	Influenza
0304746	02/12/2008	NC	25.0	25		F	02/07/2008	Hands & feet numb, can hardly walk.  Admitted to hospital.  ?Guillain Barre  ?if from influenza vaccine. records received 3/5/08-for DOS 2/5-2/12/08. DC DX:Guillain-Barre syndrome. Seconardy diagnoses:Pregnancy 19 weeks, tachycardia associated with previous pregnancies.  Presented with progressive ascending numbness and tingling which she had been experiencing over the past four weeks. Nausea and vomiting about a week prior to development of symptoms. Symptoms began in feet with numbness and tingling over the course of the day progressed to hands. Tingling tip of nose the following week. Weakness bilaterally in lower extremities and difficulty walking because of weakness. Fatigue with exertion and walking. Headaches experiencing throughout pregnancy. Treated with IVIG with improvment and susequent discharge. Follow-up: Still has some residual side effects, weakness, loss of stamina, loss of strength pain in legs, arms, hands and feet.					Y	7			Y	11/16/2007	01/01/2008	46	Admitted to another facility 3/5/08-records received-Peripheral nerve conduction studies and EMG slowing findings suggestive of demyelinating neuropathy with swelling of the right peroneal motor and possibly prolonged F-waves in right tibial motor as well as slowing in right sural sensory, however unusual findings of slowing of medial motor latency was sparing of sensory latency. MRI of brain and cervical spine no apparent abnormalities. Lumbar puncture revealed mildly elevated protein 61, glucose 65, 1 white cells.	PUB	PVT	? currently in hospital at another facility	Pregnant at time of vaccine	3/5/08-tachycardia associated with previous pregnancies.			1						1	Asthenia; CSF glucose normal; CSF protein increased; CSF white blood cell count negative; Drug exposure during pregnancy; Gait disturbance; Hypoaesthesia; Malaise; Muscular weakness; Nausea; Nuclear magnetic resonance imaging normal; Paraesthesia; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80070~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0304751	02/12/2008	WA	1.0	1	.0	M	02/04/2008	Rash-shot given 1/21/08, rash on 2/3/08 otherwise no symptoms.									U	01/21/2008	02/03/2008	13	None	PVT	PUB		None	None			1						1	Rash	FLU3~SANOFI PASTEUR~UT2474FA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB214AA~1~UN~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0215F~1~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C57539~4~UN~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1031V~1~UN~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0304755	02/12/2008	SC	15.0	15		M	02/08/2008	States he woke up this morning and his left arm was itching, a couple hours later he looked at it saw small blisters and mild redness.									Y	02/07/2008	02/08/2008	1		OTH	OTH	NONE	Itchy vesicles at injection site	None			1						1	Blister; Erythema; Pruritus	FLU3~SANOFI PASTEUR~U2435AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0304759	02/12/2008	HI	0.6	0	.6	M	02/06/2008	6 mo old male onset generalized erythematous maculo papular rash within 48 hours after vaccination.									U	02/04/2008	02/05/2008	1	None	PVT	PVT	Tylenol	None	None			1						1	Rash erythematous; Rash maculo-papular	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B132CA~3~UN~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2456LA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF215AA~3~UN~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C35174~3~UN~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0304760	02/12/2008		30.0	30		M	01/25/2008	24x11 cm Redness and Swelling Extending Below the Elbow with Pain.				Y					Y	01/24/2008	01/24/2008	0	None	OTH	MIL	None	None	None	Swelling Below Elbow~Anthrax (no brand name)~3~0.00~Patient		1						1	Erythema; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2516AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0304768	02/12/2008	NY	52.0	52		M	02/12/2008	RED BUMPS STARED TO APPEAR ON MY BACK, FEVER/HEADACHES, CHEST PAINS. WENT TO THE DOCTORS, AMBULANCE TOOK ME TO THE HOSPITAL, AFTER 5 DAYS OF QUARANTEED THEY FIGURED OUT IT WAS SWEET'S SYNDROME, TREATED WITH PREDNISONE 2/19/08-records recived for DOS 11/27-12/5/07-DC DX: Ishcemic heart disease secondary to vasculitis. Non-ST segment elevation myocardial infarction. Sweet syndrome. Hypercholesterolemia. Presented with non-ST segment elevation myocardial infarction, many skin lesions. Non purulent and no drainage boils. Headache.			Y	Y	Y	8		Y	N	11/07/2007	11/14/2007	7	MRI, CAT SCAN, HEART CATH, TWO HEART VIA THROAT SCANS, BIOPSY, CHEST X-RAY, BLOOD TESTS, EKGS 2/19/08-CT and MRI abdomen soft tissue nodule superior and immediately adjacent to lateral segment of left lobe of liver. Most likely represents a sudiaphragmatic lymph node. Pulmonary atelectatis.Culture of lesions staphylococcus capitis and enterococcus. Rheumatoid factor, ESR c-reactive protein, CK, and troponin elevated.	UNK	UNK	DEPAKOTE, LIPITOR, ZETIA, BANY ASPIRINS, ONE A DAYS	FELT SICK, FEVER/HEADACHES, CHEST PAINS 2/19/08-HX of a cold for 4 days.	PENICILLIN ALLERGY, EPILEPTIC 2/19/08- PMH: Epilepsy, dyslipidemia and osteoarthritis. Splenectomy.			1						1	Acute febrile neutrophilic dermatosis; Biopsy; Blood test; Catheterisation cardiac; Chest X-ray; Chest pain; Computerised tomogram; Electrocardiogram; Erythema; Headache; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TDAP~UNKNOWN MANUFACTURER~~UNK~~~TDAP (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0304772	02/12/2008	VA	38.0	38		M	10/16/2007	Referred by immunizations following Vaccine medical exemption from Clinic marking Allergy to vaccine component - Flumist and hx hypersensitivity, anaphylaxis to LAIV or eggs. History of present illness. Denied any food, egg, fish, seafood allergy; no chemical, latex, drug or vaccine related reactions; no seasonal allergies. DID c/o milk causing diarrhea when eaten with eggs but no problems with eggs....unknown if hx lactose intolerance. Hx tinia versicolor, pseudo folliculitis, roseolla and childhood colds. Denied any CV/resp, GI, neuro, MS disorders o Medication list reviewed None taken   Encounter Background Information: Pt reported receipt of FluMIst vac 11/30/2006. Within a few seconds/moments he felt tingling to back of throat and to right upper lip. He worked rest of day, went home, awoke next moring with swelling to right upper lip (cold sore). He denied SOB, difficulty swallowing, facial edema, lower/left side lip swelling, chest pain, rash/hives/itching or any distress except for right upper lip. Swelling resolved in 1 week w/use of Acyclovir. No reoccurrence since ... has hx of cold sores, no not that severe   DX: suspect herpes zoster.				Y					Y	09/21/2006	09/21/2006	0	allergy referral f/u 2/2008	MIL	MIL	none	denied	hx cold sores using prn acyclovir	denied~ ()~~0.00~Patient		1						1	Herpes zoster; Immediate post-injection reaction; Lip swelling; Oral herpes; Paraesthesia oral; Throat irritation	FLUN3~MEDIMMUNE VACCINES, INC.~500434P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0304773	02/12/2008	WI	38.0	38		F	02/12/2008	SEVERE HEADACHE AND BODY AND JOINT PAIN, SKIN HURTS, SORE THROAT, LOW GRADE FEVER-100F, LOCALIZED REACTION INITIALLY-REDNESS & SWELLING.				Y					N	02/10/2008	02/10/2008	0		UNK	UNK	WELLBUTRIN, GAVISTIN, EFFEXOR, MULTIVITAMINS	NONE	NONE	NONE~ ()~~0.00~Patient		1						1	Arthralgia; Erythema; Headache; Local reaction; Local swelling; Pain; Pain of skin; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U2476GA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0304794	02/12/2008	AL	11.0	11		M	02/07/2008	Erythema and swelling at injection site within 5 days of vaccine									U	02/05/2008			none	PVT	PUB	Elocin; Selsun shampoo	Eczema. Tinea vesicular	Obesity; Eczema. Refraction environ			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2487AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0854U~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0304821	02/13/2008	KY	1.0	1	.0	F	02/07/2008	Subject number: 01700084.  Initial report received on 31 January 2008 from an investigator participating in a trial under the reference number MTA37.  A 12-month-old female subject experienced a febrile seizure one day after receiving an intramuscular right thigh injection of Menactra (lot number U2172AA, dose two) and an intramuscular left thigh injection of Prevnar (Wyeth, lot number B53981A).  The subject received both injections during a well-child visit on 29 January 2008, and physical exam was noted to be within normal limits with tympanic membranes pearly gray and canals clear.  According to her parents she began experiencing a low-grade fever (100.5 degrees Fahrenheit, rectal), decreased activity, and several episodes of crying later that day.  Upon waking up from her nap, her temperature was noted to be 103.1, and it continued to be elevated throughout the evening and into the following morning.  Prior to her nap on 30 January 2008, the subject's temperature was noted to be 103.9.  After hearing a noise, her mother later checked on her and observed the subject having a seizure, which she reporting as lasting approximately three minutes.  She was taken to her physician's office, where her right tympanic membrane was noted to be red.  She was diagnosed with a febrile seizure and acute suppurative otitis media of the right ear, and a complete blood count (CBC) with differential was ordered.  Laboratory testing revealed the following: white blood count 11.1 THS/uL (normal 4.8-10.8), with absolute monocytes 1.0 THS/uL (normal 0.0-0.8); red blood count 3.73 MIL/uL (normal 4.04-4.85); hemoglobin 10.1 G/DL (normal 11.3-12.3); hematocrit 29.2% (normal 37-41); and MCV 78.3 FL (normal 80-95).  Treatment included a 500mg intramuscular injection of Rocephin, and Tylenol.  On 31 January 2008, the subject's temperature was 100.7, and her mother noted that her activity level was increasing.  The febrile seizure was considered to be resolved on 30 January 2008, and the subject continued in the trial.  According to the investigator, the event was related to Menactra and Prevnar.  Documents held by sender: labs, office notes.				Y					Y	01/29/2008	01/30/2008	1	Laboratory testing revealed the following: white blood count 11.1 THS/uL (normal 4.8-10.8), with absolute monocytes 1.0 THS/uL (normal 0.0-0.8); red blood count 3.73 MIL/uL (normal 4.04-4.85); hemoglobin 10.1 G/DL (normal 11.3-12.3); hematocrit 29.2% (normal 37-41); and MCV 78.3 FL (normal 80-95).	UNK	UNK					200800331	1						1	Crying; Decreased activity; Febrile convulsion; Haematocrit decreased; Haemoglobin decreased; Mean cell volume decreased; Monocyte count increased; Otitis media acute; Pyrexia; Red blood cell count decreased; Tympanic membrane hyperaemia; White blood cell count increased	FLU3~SANOFI PASTEUR~U2513A~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2172A~2~IM~RL~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PNC~PFIZER\WYETH~B53981A~UNK~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0304825	02/13/2008	CA	64.0	64		F	02/08/2008	Pt called to report that she went to her PMD to check her injection site from Flu vaccine given intramuscularly on 11/31/07 that it was red and inflamed. RN did not witnessed the site. Per pt her PMD said no signs of abscess on site, no drainage noted but was given Amoxicillin 500mg TID X 10 days. Had taken 1st dose today and was feeling much better. Per pt, no pain on site and less redness noted. Informed Dr of incident. Pt was given flu vaccine on 10/31/07 IM on R deltoid muscle, not breaking any aseptic technique. Hand washing properly observed and site properly prepped and applied band aid on site of injection.									U	10/31/2007	11/05/2007	5		UNK	UNK			Allergies: Penicillin, Metronidazole, Vicodin			1						1	Injection site erythema; Injection site inflammation	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0304836	02/13/2008	CA	23.0	23		F	02/13/2008	ONE HOUR AFTER RECEIVING INFLUENZA VACCINATION PATIENT BEGAN TO FEEL DIZZY AND RIGHT SIDE OF BODY BECAME RED/HOT TO TOUCH				Y					Y	11/02/2007	11/02/2007	0	NONE	MIL	MIL						1						1	Dizziness; Erythema; Skin warm; Dizziness; Erythema; Skin warm	FLUN3~MEDIMMUNE VACCINES, INC.~500496P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500496P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Emergency room visit	Influenza
0304837	02/13/2008	TX	14.0	14		M	02/13/2008	Since my son recieved the flu vaccine on December 4th, 2007, he has had recurring hives that break out all over his body.  The night after the shot the top of his foot began to swell with a huge hive and then he started breaking out on his stomache. I took him to the doctor who gave him a steroid shot and some antibiotics and he told me that it was either a side effect from the shot or MRS infection.  Only the hives went away and returned a couple of days later and my son was broke out on his stomache chest and back. This continues on every couple of days even with benadryl.  The Day I took my son to the doctor he was getting a physical and was approved to participate for athletics and while we were there I let them give him the flu shot so he wouldn't get sick and have to miss any school because of the flu.  Also prevously back in October my son was Allergy tested by doctor and they said that he had no allergies. Patient has missed alot of school because of the constant hive out breaks.  Family doctor has run two different blood tests and a sinus x-ray and said they came back normal.  Patient hives branched into his face and swelled his left side of his face including the eye and upper lip.  He was reffered back to Dr. for allergy treatment. He is now taking Zerteck, benadrl, singular, albuterol inhaler, nexium, and advair was prescribed for him. He has had two or three steroid shots and nothing gets rid of the hives for very long and they seem to be getting worse in the break outs. Dr said that every time he breaks out that it is affecting his   internal organs.   Please help me find a cure for this. Patient never had broke out in hives before the flu shot.  My son is scared and I don't know what to tell him.				Y					N	12/04/2007	12/05/2007	1		UNK	UNK	At the time only an occaisional use of albuterol inhaler, but had not used in awhile.	none	when the allergist tested Patient in October he said that Patient no allergies and that he didn't have asthma.  Patient did over the summer have a cold.			1						1	Activities of daily living impaired; Blood test normal; Eye swelling; Face and mouth X-ray normal; Lip swelling; Oedema peripheral; Swelling face; Urticaria	FLU3~SANOFI PASTEUR~U2508AA~1~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0304839	02/13/2008	IL	0.58	0	.6	M	02/13/2008	Temp 104.6, patient fussy, crying.  All follow up lab work negative, no other signs and symptomes.				Y					Y	01/23/2008	01/23/2008	0	CBC and BMP WNL, RSV and Influenza A & B negative.   Chest xray clear.	PVT	UNK	none	none	none			1						1	Body temperature increased; Chest X-ray normal; Crying; Full blood count normal; Influenza serology negative; Irritability; Metabolic function test normal; Virus serology test	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~ac21b128ab~3~IM~GM~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~u2481fa~1~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~uf297aa~3~IM~GM~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~b54012e~1~IM~GM~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0304856	02/13/2008	OR	11.0	11		F	02/07/2008	Injection site redness/swelling & warm to the touch, itching.  Pt given ibuprofen & Benadryl w/ relief.  Advised to continue ibuprofen & Benadryl along w/ ice compression as needed.				Y					Y	02/05/2008	02/06/2008	1		UNK	UNK		None	NKDA			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Pruritus	FLU3~SANOFI PASTEUR~UT2475AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB200AA~2~IM~LA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2552AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TD~SANOFI PASTEUR~C2826AA~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~1475U~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0304860	02/13/2008	PA	4.0	4		M	02/13/2008	Localized Edema left thigh. Sites of DTAP and IPV and Varicella				Y					Y	02/12/2008	02/12/2008	0		PVT	UNK	None	None	None - Peanut Allergy			1						1	Injection site oedema; Localised oedema	DTAP~SANOFI PASTEUR~C2799A~5~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2501AA~4~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0474-2~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1670U~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1473U~2~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0111958	02/14/2008	NC	52.0	36		F	02/11/2008	I can't think of anything more cruel.  Why didn't doctors tell me about the vaccine adverse reporting system?  I've had to live off of 350.00 a month or less since November 1991.  I could work full-time before that flu shot!				Y				Y	N	11/01/1991	11/01/1991	0	December 1991 started going to doctor.	PUB	PVT		None that I know of				1						3	Abdominal pain; Alcohol problem; Amnesia; Arthralgia; Asthma; Balance disorder; Chronic fatigue syndrome; Delirium; Disability; Disturbance in attention; Drug hypersensitivity; Dyspnoea; Eye irritation; Feeling of body temperature change; Fibromyalgia; Fungal infection; Insomnia; Liver disorder; Migraine; Multiple chemical sensitivity; Myalgia; Nausea; Paranoia; Photosensitivity reaction; Skin irritation; Throat irritation; Activities of daily living impaired	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Disabling	Influenza
0304894	02/14/2008	NJ	38.0			F	02/01/2008	Medical history and concomitant medications were not reported. The patient received FluMist vaccine on 19-Nov-2007. On 23-Nov-2007, four days after receiving FluMist vaccine, the patient developed glomerunephritis. No additional information was reported. The event of glomerulonephritis subsequently resolved on an unreported date. The patient did not experience a rechallenge while receiving the suspect product. The reporter did not provide a statement of causality. The sponsor considered the glomerulonephritis an important medical event. The reporting source of this case is spontaneous, thus the reporter's comment is not applicable.									Y	11/19/2007	11/23/2007	4		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0006514	1						1	Glomerulonephritis	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0304895	02/14/2008	ME	0.59	0	.6	F	02/08/2008	0.25ml Fluviron given. Rec for >4yrs. Marked on box not actual vial. No Reaction									Y	01/07/2008				PVT	UNK						1						1	Inappropriate schedule of drug administration; No adverse reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80956~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0304896	02/14/2008	ME	0.88	0	.9	F	02/08/2008	0.25ml Fluvirin given, rec >4 yrs.  No reaction.									Y	01/07/2008	02/08/2008	32		PVT	UNK						1						1	Wrong drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0304897	02/14/2008	ME	1.01	1	.0	M	02/08/2008	0.25 ml fluviron given.  Rec for 74 yrs.  No reaction.									Y	02/05/2008			None	PVT	UNK		None	None			1						1	Wrong drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80956~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0304899	02/14/2008	ME	0.77	0	.8	F	02/08/2008	0.25 ml Fluvirin given, rec >4 yrs, no reaction.									Y	01/10/2008	02/08/2008	29		PVT	UNK						1						1	Inappropriate schedule of drug administration; No adverse reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80956~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0304900	02/14/2008	ME	2.0	2	.0	M	02/08/2008	0.25 ml Fluviron given Rec >4 yrs no reaction									Y	01/10/2008	02/08/2008	29		PVT	UNK						1						1	Inappropriate schedule of drug administration; No adverse reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80956~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0304901	02/14/2008	ME	1.21	1	.2	M	02/08/2008	0.25ml Fluvirin given, >4yrs rec, no reaction.									Y	01/09/2008	02/08/2008	30		PVT	UNK						1						1	Inappropriate schedule of drug administration; No adverse reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80956~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0304903	02/14/2008	ME	0.56	0	.6	M	02/08/2008	0.25 ml Fluviron given > 4 yrs Rec no reaction									Y	01/30/2008				PVT	OTH						1						1	Inappropriate schedule of drug administration; No adverse reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80956~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0304904	02/14/2008	ME	2.0	2	.4	M	02/08/2008	0.25ml Fluviron given Rec >4yrs; No reaction									Y	01/11/2008				PVT	UNK						1						1	Wrong drug administered	FLU3~LEDERLE LABORATORIES~80956~UNK~UN~UN~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0304905	02/14/2008	ME	0.65	0	.7	M	02/08/2008	0.25 ml fluviron given.  Rec 74 yrs.  No reaction.									Y	01/11/2008	02/08/2008	28	None	PVT	PVT		None	None			1						1	Wrong drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~809S6~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0304906	02/14/2008	ME	0.81	0	.8	M	02/08/2008	0.25ml Fluvirin given, rec >4 yrs, no reaction.									Y	01/09/2008	02/08/2008	30		PVT	UNK						1						1	Inappropriate schedule of drug administration; No adverse reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80956~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0304907	02/14/2008	ME	0.7	0	.7	M	02/08/2008	0.25 ml Fluviron given Rec >4 yrs no reaction									Y	01/08/2008	02/08/2008	31		PVT	UNK						1						1	Inappropriate schedule of drug administration; No adverse reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80956~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0304909	02/14/2008	ME	0.59	0	.6	M	02/08/2008	0.25 ml fluviron given.  Rec 74 yrs.  No reaction.									Y	02/07/2008	02/08/2008	1	None	PVT	UNK	None	None				1						1	Wrong drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80956~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0304911	02/14/2008	ME	1.37	1	.4	M	02/08/2008	0.25ml Fluvirin given to pt, rec >4 yrs.  Box marked but not an actual vial.  Pt had no reaction.									Y	02/07/2008	02/08/2008	1		PVT	UNK						1						1	Inappropriate schedule of drug administration; No adverse reaction	DTAP~SANOFI PASTEUR~80956~UNK~UN~UN~DTAP (DAPTACEL)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0304912	02/14/2008	ME	3.0	3		F	02/08/2008	0.5 ml Fluviron given to pt Rec for >4 yrs. Box marked but not actual vial. Pt had no reaction									Y	02/01/2008	02/08/2008	7		PVT	OTH						1						1	Inappropriate schedule of drug administration; No adverse reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80956~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0304914	02/14/2008	ME	0.53	0	.5	M	02/08/2008	0.25ml Fluvirin given, rec for >4 yrs.  Box marked but not on actual vial.  Pt had no reaction.									Y	01/29/2008	02/08/2008	10		PVT	UNK						1						1	Inappropriate schedule of drug administration; No adverse reaction	DTAP~SANOFI PASTEUR~~UNK~UN~UN~DTAP (DAPTACEL)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~MERCK & CO. INC.~80956~UNK~UN~UN~HEP B (FOREIGN)~1|PNC~PFIZER\WYETH~~UNK~UN~UN~PNEUMO (PREVNAR)~1	USA		Influenza
0304915	02/14/2008	ME	1.32	1	.3	F	02/08/2008	0.25 ml Fluviron given. Rec for > 4 yrs. Box marked but not on actual vial. Pt had no reaction.									Y	01/29/2008	02/08/2008	10		PVT	OTH						1						1	Inappropriate schedule of drug administration; No adverse reaction	DTAP~SANOFI PASTEUR~80956~UNK~UN~UN~DTAP (DAPTACEL)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0304916	02/14/2008	DE	0.56	0	.6	F	02/08/2008	0.25ml Fluvirin given.  Rec for >4yrs.  Box marked but not on actual vial.  Pt had no reaction.									Y	01/25/2008	02/08/2008	14		PVT	UNK						1						1	Inappropriate schedule of drug administration; No adverse reaction	DTAP~SANOFI PASTEUR~~UNK~UN~UN~DTAP (DAPTACEL)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~~UNK~UN~UN~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~~UNK~UN~UN~PNEUMO (PREVNAR)~1	USA		Influenza
0304918	02/14/2008	ME	0.83	0	.8	F	02/08/2008	0.25 ml Fluviron given. Vaccine meant > 4 yrs. Marked on box but not marked on actual vial. Pt had no reaction.									Y	01/22/2008	02/08/2008	17		PVT	UNK						1						1	Inappropriate schedule of drug administration; No adverse reaction	DTAP~SANOFI PASTEUR~~UNK~UN~UN~DTAP (DAPTACEL)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~~UNK~UN~UN~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~80956~UNK~UN~UN~PNEUMO (PREVNAR)~1	USA		Influenza
0304920	02/14/2008	ME	1.31	1	.3	F	02/08/2008	Patient given 0.25 ml fluviron vaccine for >4 yrs.  Marked on box.  Not marked on actual vial.  Patient had no reaction.									Y	01/18/2008			None	PVT	UNK	None	None	None			1						1	Wrong drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80956~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0304922	02/14/2008	ME	3.0	3		M	02/08/2008	0.5ml fluviron was given to patient.  Vaccine for 44 yrs and older.  Warning on box but not on actual vial.  Patient had no reaction.									Y	01/18/2008			None	PVT	UNK	None	None	None			1						1	Wrong drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80956~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0304923	02/14/2008	ME	0.65	0	.6	M	02/08/2008	0.25 ml fluviron given.  Vaccine meant for 44 yrs and older.  Warning on box but not on actual vial.  Patient had no reaction.									Y	01/18/2008	01/22/2008	4	None	PVT	UNK		None	None			1						1	Wrong drug administered	FLU3~MEDEVA PHARMA, LTD.~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0304927	02/14/2008	DC	1.1	1	.1	M	02/07/2008	Patient presented to office today with complaint of rash all over body, papular, fine erythema. Was last in office 1/28/08; Received 1 yr vaccines at that time. Rash started yesterday 2/6/08				Y					U	01/28/2008	02/06/2008	9	None	PVT	PUB	Amox prescribed at 1/28/08 visit	bad cold - acute otitis media	none			1						1	Erythema; Rash generalised; Rash papular	FLU3~SANOFI PASTEUR~U2502AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB225CA~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1181F~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1583U~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0304938	02/14/2008	MN	15.0	15		F	09/25/2007	Syncope.  Pt. received vaccinations with TdaP & Influenza.  Shots L arm each separated by ~15 seconds, then received Menactra R arm & no problems, 4th vaccine Gardasil R arm.  Pt had pain with RUSH up arm & within seconds of shot fell off exam table to R side striking R frontal parietal area and few seconds LOC with vagal type appearance.				Y					U	09/25/2007	09/25/2007	0	None	PVT	UNK		None	None			1						1	Fall; Head injury; Loss of consciousness; Pain in extremity; Syncope vasovagal	FLU3~SANOFI PASTEUR~U2445AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0388U~UNK~UN~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2382BA~UNK~UN~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2731AA~UNK~UN~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0304943	02/14/2008	CA	5.0	5		M	02/14/2008	Severe Pain and swelling at the site of injection. Developed fever up to 103 F. Limping with pain. Thigh X-ray within normal limits. Symptoms lasted for 4 days and treated with Ice pack, Ibuprofen and Keflex for presumed cellulitis.				Y					Y	10/26/2007	10/27/2007	1	Sed Rate 63, WBC 17900 Neutrophils 79.3% X-rat Thigh, Knee and Hip reported within normal limits.	UNK	UNK		Mild Nasal Congestion	Asthma and Wheezing			1						1	Cellulitis; Gait disturbance; Injection site pain; Injection site swelling; Neutrophil percentage increased; Pyrexia; Red blood cell sedimentation rate increased; White blood cell count increased; X-ray limb normal; X-ray of pelvis and hip normal	FLU3~SANOFI PASTEUR~U2461184~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577U~1~IM~LL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0304957	02/14/2008	GA	14.0	14		F	02/14/2008	Patient was ordered for TdaP, but nurse inadvertently administered DTaP.									U	02/11/2008	02/11/2008	0		UNK	UNK	OTC Pepcid	Abd pain	Allergic rhinitis, Asthma			1						1	Wrong drug administered	DTAP~SANOFI PASTEUR~U2290BA~5~IM~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2523AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB217BA~1~IM~LA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~0522U~1~IM~RL~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U241AA~1~IM~LL~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0304959	02/14/2008	OH	1.01	1	.0	M	02/14/2008	PRESENTED TO OFFICE 11/12/2007 COMPLAINING OF REDNESS, HEAT AND SWELLING OF RIGHT THIGH AT SITE OF PREVIOUS VACCINE.  DIAGNOSED WITH STERILE ABSCESS AND TREATED WITH BACTRIM PEDIATRIC SUSPENSION PO FOR 10 DAYS.				Y					Y	10/27/2007	11/12/2007	16		UNK	UNK		URI				1						1	Abscess; Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2529AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B54007H~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1117U~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0304962	02/14/2008	MI	20.0	20		M	02/14/2008	10.10 injections administered: HAV Lot# 0019U, HBV Lot # 0723F, Influenza No preservative U2476A 10.15 c/o itching, no rash 10.20 Benadryl OTC is given by personnel 10.30 Itching continues, c/o tingling in throat, no acute distress, no trouble breathing 11.00 Admitted to ER in stable condition, recovered completely, sent back to facility in stable condition				Y					Y	02/01/2008	02/01/2008	0		UNK	UNK		none	NKA, Hepatitis C (+)			1						1	Pruritus; Throat irritation	FLU3~SANOFI PASTEUR~U2476A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0723F~UNK~IM~LA~HEP B (RECOMBIVAX HB)~1|HEPA~MERCK & CO. INC.~0019U~1~IM~RA~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0304964	02/14/2008	FL	55.0	55		M	02/14/2008	Flu Vaccine on 11/06/2007, numbness of feet then legs and hands then severe weakness of limbs coming on gradually, starting 1-2 weeks after vaccine, now starting to improve but still symptomatic with weakness numbness and gait imbalance as of 02/14/2008. 1/20/2010 Improved but still weak from Guillian Barre. 02/29/2008 MR received from neurologist for multiple visits 1/2/08 to 2/14/08 with DX:  Guillain-Barre Syndrome. Initially presented 2/1/08 with 2 month hx of numbness in hands and feet and weakness of the legs and hands which has recently been worsening.  PE (+) for moderate hand weakness, mild weakness of dorsiflexors and plantar flexors of the foot and toes, inability to walk on toes or heels, stocking-glove sensory loss, and diminished vibratory sense of the feet and toes. Borderline Romberg's and gait difficulty. Pt later reported band-like numbness around the abdomen and increasing difficulty walking. Tx with plasmapheresis. Possible post vaccinal GBS.  3/31/08 MR received for hospital DOS 1/11-19/2008 with D/C Dx: Demyelinating neuropathy of recent/acute onset.  Barrett esophagitis.  Hx of cholecystitis, s/p recent cholecystectomy.  Hypercholesterolemia. Records also sent for DX of Cholecystitis DOS 12/21-24/2007 and 12/31/07-1/1/08 with c/o Leg and arm numbness and leg weakness.  Pt initially presented 12/31/07 with 6 week hx of numbness of the extremities and unsteady gait. PE (+) for decreased sensation in the feet, brisk DTRs, decreased motor strength, unsteady, staggering gait.   Tx with steroids and D/c to be f/u as an outpt. Pt presented again 1/11/08 with progressive numbness and admitted with DX of Acute Demyelinating Polyneuropathy for plasmapheresis. C/O dyspnea  noted on consult of 1/12/08. D/C to continue rehab as outpt. Pt. is improving in symptoms-this stated in Dr. visit on 3/26/08.				Y	Y	13	Y	Y	Y	11/06/2007	11/14/2007	8	EMG NCV Tests, LAB Tests, CSF EXAM, MRI, CT scan.  Labs and Diagnostics:  EMG and NCS c/w demyelinating neuropathy.  CSF cell counts WNL with Atypical reactive appearing monocytoid cells present.  CSF protein 151.8.  CSF cultures (-). 24 hr urine creatinine WNL.Labs and Diagnsotics:  IgG Subclasses 1,2, and 3 all low. ESR 19. protein electrophoresis with elevated Alpha-2-macroglobin.  heavy metal testing (-) except urine Cadmiun high at 3.9.	UNK	UNK	Prilosec 20mg bid, Simvastatin 40mg qd	n/a	none. PMH: recent cholecystectomy, insulin resistance, hypercholestermia, and GERD.  Recent 90# weight loss.			1						1	Balance disorder; Computerised tomogram; Dyspnoea; Gait disturbance; Hypoaesthesia; Laboratory test; Muscular weakness; Nuclear magnetic resonance imaging	FLU3~SANOFI PASTEUR~U2531AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0304966	02/14/2008	GA	27.0	27		F	02/14/2008	C/O chills and shaking approx. 3:00 pm 02/13/08 and feeling cold during the night/ took Tylenol ES one tab. Developed H/A and facial swelling this morning.  Temp 104.3, HR 120, BP 110/60, lungs clear, pulse SA 02 97%. Tylenol 325 mg 2 tabs and Benadryl 25mg one tablet given 10:00am today.				Y					Y	02/13/2008	02/13/2008	0		UNK	UNK	Denies	Anxiety Disorder	Denies			1						1	Blood pressure; Body temperature increased; Chills; Feeling cold; Headache; Heart rate; Oxygen saturation; Swelling face; Tremor	FLU3~SANOFI PASTEUR~U2524AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0304968	02/14/2008	WA	45.0	45		F	02/14/2008	Nausea, vomiting, dry heaving, lightheadedness, dizziness, low grade fever, loss of apeptite, weakness, fatigue/tiredness.				Y					U	02/05/2008	02/05/2008	0	Examined by Doctor in Clinic.	UNK	UNK	Zoloft, Dilantin, Lisinopril, Aspirin, Iron Supplement, Vitamin Supplements	None	Allergic to Duracef                     Epilepsy, Diabetes, Chronic Depression, Hypertension, Anemia			1						1	Anorexia; Asthenia; Dizziness; Fatigue; Nausea; Pyrexia; Retching; Vomiting; Wrong drug administered	DTAP~SANOFI PASTEUR~C2862AA~1~IM~RA~DTAP (TRIPEDIA)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~Unknown~1~IM~GM~INFLUENZA (SEASONAL) (FLULAVAL)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~Unknown~1~IM~LA~HEP A + HEP B (TWINRIX)~1	USA	Emergency room visit	Influenza
0304982	02/14/2008	NC	58.0	58		F	02/14/2008	This case was reported by a pharmacist and described the occurrence of arm soreness at injection site in a 58-year-old female subject who was vaccinated with Fluarix for prophylaxis. No relevant medical history. The subject had previously received influenza vaccines and had not experienced any reactions. On 14 November 2007 at 17:00 the subject received unspecified dose of Fluarix (.5 ml, unknown arm). No other vaccines were received on 14 November 2007 with Fluarix. On 14 November 2007, less than one day after vaccination with Fluarix, the subject experienced arm soreness at injection site and tenderness at arm injection site. Approximately one week after the subject was vaccinated with Fluarix, she experienced weak arm muscles, especially at night, and she could not use her arm very well. The pharmacist noted that this has eased some but at certain times her arm feels weak. Medical attention was required at the physician's office. The pharmacist considered the events were disabling. At the time of reporting the events were ongoing and improved. The pharmacist considered the events were probably related to vaccination with Fluarix.				Y				Y	N	11/14/2007	11/14/2007	0	UNK	OTH	PVT		Unknown	The subject had previously received influenza vaccinations and no reactions were experienced with previous influenza injections. This reporter also stated that the subject reported that a co-worker experienced similar problems after her or she received an influenza vaccine (unknown manufacturer). The pharmacist did not have the specifics of the type of events experienced by the co-worker. See manufacturer number A0709426A for details of this case.		A0709413A	1						1	Injected limb mobility decreased; Injection site pain; Muscular weakness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA298BA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Disabling	Influenza
0304988	02/14/2008	OR	1.1	1	.1	F	02/14/2008	Received VZV vaccine on 2/4/08.  Had tactile fever on 2/12-2/13.  On 2/14/08 developed diffuse erythematous maculopapular rash on abdomen, chest, back, neck, cheeks.  Afebrile in clinic.									U	02/04/2008	02/12/2008	8	None	PVT	PUB		None	None			1						1	Erythema; Pyrexia; Rash maculo-papular	FLU3~SANOFI PASTEUR~UT2475AA~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB213AA~UNK~UN~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0747U~UNK~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1579U~UNK~UN~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0304995	02/14/2008	VA	48.0	48		M	02/14/2008	Persistent pain, weakness, left deltoid muscle.  No pain or problem at time of injection.  2 weeks later he felt pain in deltoid region.  Some upper arm movements.  1-2 times a week now in last 2 weeks he has noted this pain 3-4 times a day with swelling, redness or lump.									N	12/12/2007	12/26/2007	14		MIL	UNK		None	Mild cervical disc problems 2 MVA's			1						1	Asthenia; Erythema; Mass; Pain; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA309BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0305002	02/14/2008	ME	1.36	1	.4	F	02/08/2008	Pt was given 0.25 ml of Fluviron. Did not realize it was for ages 4 and older. No reactions. Warning was on box not on actual vial.									Y	01/15/2008	02/08/2008	24		PVT	UNK						1						1	Wrong drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~MERCK & CO. INC.~80956~UNK~UN~UN~HEP B (FOREIGN)~1|PNC~PFIZER\WYETH~~UNK~UN~UN~PNEUMO (PREVNAR)~1	USA		Influenza
0304970	02/15/2008	GU	43.0	43		F	02/15/2008	Since flu vaccination right arm tender. Few hours later gnawing ache right deltoid Like someone punched arm no fever. By Thursday 02/14/08 late PM increase pain, woke up Friday AM increase pain/unable to stretch right arm. Took Tylenol. Referral given for evaluation at pvt. MD.									U	02/12/2008	02/14/2008	2		UNK	UNK	unknown	none	unknown	unknown~ ()~~0.00~Patient|unknown~ ()~~0.00~Sibling|unknown~ ()~~0.00~Sibling		1						1	Injected limb mobility decreased; Myalgia; Tenderness	FLU3~SANOFI PASTEUR~U2490AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U1880CA~UNK~IM~LA~TD ADSORBED (TENIVAC)~1	USA		Influenza
0305003	02/15/2008	MS				U	02/12/2008	Initial report received on 04 February 2008 from a health care professional. On an unknown date, 10 children (demographics not provided, ages unknown) received a dose of Fluzone (Lot number U2493AA). The route and sites of administration were not provided. At an unspecified amount of time later, all 10 children developed influenza; however no diagnostic testing was performed, or strain identified. It was unknown if any of the children had any illnesses or pre-existing medical conditions at the time of the vaccination. No other relevant medically significant information was provided.				Y									No tests done, no strain identified.	UNK	UNK			Unknown		200800374	1						1	Influenza	FLU3~SANOFI PASTEUR~U2493A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0305031	02/15/2008	TX	29.0	29		F	02/15/2008	Employee received influenza vaccine on 2/13/08 at approximately 2:00 pm.  She immediately reported tingling and numbness to injection site on right arm radiating to right hand.  On 2/15/08 she reported that approximately 2 hours after injection she felt chills, bodyaches, watery eyes, runny nose, cough and pain to back along side spine and cramping to pelvic region.  She was escorted to ER for evaluation and treatment.				Y					U	02/13/2008	02/13/2008	0	History of Asthma	UNK	UNK		None	Asthma			1						1	Asthma; Back pain; Chills; Cough; Injection site anaesthesia; Lacrimation increased; Pain; Paraesthesia; Rhinorrhoea	FLU3~SANOFI PASTEUR~U2466AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0305033	02/15/2008	TN	66.0	66		F	02/15/2008	Patient receive pneumoccal vaccination in left deltoid muscle. Returned to clinic 2 days post vaccination with redness and warmth to lower part of left upper arm. Instructed patient to take Benadryl 25mg one tablet every 4-6 hrs prn and IBU 200mg prn for pain.									Y	02/11/2008	02/11/2008	0		UNK	UNK		none	none			1						1	Erythema; Skin warm	FLU3~SANOFI PASTEUR~U2442AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1084U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0305040	02/15/2008	WA	3.0	3		M	02/12/2008	Flu vaccine given 0.5ml 2/8/08.  Woke up 2/9/08 with swollen face.  No other swelling.  Illness, swelling lasted until 2:30 pm 2/9/08.  Resolved with Benadryl.									Y	02/08/2008	02/09/2008	1		PVT	PUB		None	None			1						1	Swelling face	FLU3~SANOFI PASTEUR~U2453AA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0305043	02/15/2008	CO	64.0	64		F	02/13/2008	On 11/21 the husband noticed that patient was having confusion and forgetting little things.  The husband notified the PCP who advised him to take the patient to the hospital. Prior to this the patient was treated on 10/24/07 for pneumonia with 7 days of Avelox. On 11/5 the patient came to the clinic complaining of myalgias. This was ruled to be a viral process. On 11/16 the patient recieved the influenza vaccine in the clinic.  The morning of 11/21 the patient woke up with a headache and progressively became disoriented with muscle weakness and by 4pm that day could not talk.  Once at the hospital the patient was given steroids, antibiotics, and antifungals.  The patient improved for two days and then got progressively worse each day after that.  The patient became completely unresponsive, pupils fixed and dilated by 11/28. Patient expired on 11/28.  Diagnosis was unclear. Patient with definite demylinating process and encephalopathy, so vaccine reaction was in the differential. However some of the symptoms did start prior to receiving the vaccine.  8/26/08 Death certificate states COD as acute disseminated encephalomyelitis.    2/19/08 Reviewed hospital medical records of 11/21-11/28/2007. FINAL DX: acute disseminated encephalomyelitis; hyperlipidemia; pre-diabetes; & HTN. Records reveal patient experienced confusion, disorientation & loss of speech x 1 day   Admitted 11/21-11/28/2007 when she expired.  Exam revealed inability to speak but was able to mime; cranial nerve exam WNL, general muscle weakness w/reflexes intact.  Tx w/antibiotics, steroids, antivirals & prophylactic antiseizure meds.  Received IVIG x 2.  By hospital day #4, conditioned worsened & was unresponsive w/left side weakness.  C/S neg & antibiotics/antivirals were d/c.  Continued to deteriorate & on vent.  Family decision to withdraw tx as condition contined to worsen & pt expired.   5/2/08 Reviewed pcp medical records which included vax record that confirms as reported.  Office note of 11/16/07 was for flu shot only, no pcp note.  10/24 vs for URI s/s x approx 1 week.  Runny nose, facial tenderness, lightheadedness, cough, LBP, poor appetite.  Apouse had been ill w/viral syndrome.  CXR that day revealed patchy RUL infiltrate; CBC WNL.  10/29 visit reveals patient seen in f/u for pneumonia, dermatitis & pain in left shoulder.  She had less cough & improved appetite but was still tired.  CXR that day revealed near resolution of pneumonia.  Records also included some hospital medical records. Neurosurgery & neurology consults done.  Patient w/fever on admission.	Y	11/28/2007							N	11/16/2007	11/21/2007	5	LABS: CT of head & MRI of brain c/w ADEM.  CSF WBCs 789(H), polys 89%.  Repeat CT scan revealed worsening demyelination.  Blood & CSF c/s neg.  Brain biopsy revealed ADEM.   WBC 15,500.  CT abdomen/pelvis revealed fatty liver & gallbladder distension, both mild.  CXR WNL.	UNK	UNK	None at the time of vaccination	Had pneumonia 2 weeks prior and then had a viral illness one week prior.	Hypertension, dermatitis, pre-diabetes; Allergic to codeine, sulfa, neosporin, and penicillin  Capillaritis, post inflammatory hyperpigmentation of LEs, sinusitis, constipation, impaired glucose metabolism.  Allergies: congestac, Vioxx, ASA, codeine, bactrim, neosprin.			1						1	Aphasia; Confusional state; Death; Demyelination; Disorientation; Headache; Memory impairment; Muscular weakness; Myalgia; Mydriasis; Pupil fixed; Unresponsive to stimuli	FLU3~SANOFI PASTEUR~U2454AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0305051	02/15/2008	NC	61.0	61		F	02/15/2008	Soreness at site of injection, erythema.				Y					U	02/06/2008	02/08/2008	2		UNK	UNK	Unk	No	aspirin, codeine, tetracycline			1						1	Erythema; Injection site pain	FLU3~SANOFI PASTEUR~U2440AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0305054	02/15/2008	ND	23.0	23		M	02/15/2008	Vaccination administered at 1000 hr on 11/8/07.  Patient developed fever at 2000 hr and went to Emergency Room.  Fever in ER notes at 100.3 and man complained of abdominal pain that he has had off and on for one week. He states tests done to check for appendicitis, nothing found and discharged and he was feeling better.				Y					Y	11/08/2007	11/08/2007	0	Need to check with Medical Center	UNK	UNK	none	abdominal pain x 1 week	none	none~ ()~~0.00~Patient|none~ ()~~0.00~Sibling		1						1	Abdominal pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA0300AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0305065	02/15/2008	AK	5.0	5		M	02/15/2008	Temp 100.9 for 4 hours on 2/14/08, 12cm heterogeneous pink, slightly indurated area on left leg.  3cm erythematous area on right leg.  Temp 98.0 oral on 2/15/08 in office.									Y	02/13/2008	02/14/2008	1	None	PVT	OTH						1						1	Body temperature increased; Induration; Rash erythematous; Skin discolouration	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B051AA~5~IM~LL~DTAP (INFANRIX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80822~3~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~A0169~4~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|VARCEL~MERCK & CO. INC.~1464U~2~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0305067	02/15/2008	CA	2.0	2	.7	M	01/02/2008	Right thigh with 17 1/2cm x 18 1/2cm swelling and erythema surrounding injection site, warm and indurated.  No fluxuence noted.									Y	12/27/2007	12/27/2007	0	None	PVT	PVT		None	None			1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~UT2459MA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0305222	02/15/2008	TX	4.0	4		M	01/24/2008	A serious post-marketed study report of severe dehydration with anion gap metabolic acidosis and pneumonia was received from a physician concerning a four-year-old male subject.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  The subject has a past medical history significant for congenital glaucoma, cataracts of both eyes, and adrenal insufficiency at nine months of age to exogenous steroid administration for management of glaucoma.  Past medical history is significant for four prior hospitalizations for similar symptoms described below.  Exposure history is significant that the subject attends daycare with exposure to other ill children.  Also subject's mother and 18-month-old brother both had a recent upper respiratory tract illness.  There was no information on concomitant medications.  The subject received FluMist on 29-Nov-2007.  On 10-Dec-2007, the subject developed cough, congestion, and runny nose with occasional emesis and shortness of breath.  On 22-Dec-2007, the subject had increased non-bilious and non-bloody emesis, diarrhea, and fever.  The subject was seen at the urgent care clinic on 24-Dec-2007 and was diagnosed with right middle lobe pneumonia and started on Azithromycin.  Because of continued symptoms with fever and decreased oral intake and urine output, the subject was reevaluated in the emergency room on 25-Dec-2007.  Physical exam was notable for dry mucous membranes and capillary refill of two-three seconds.  His breath sounds were clear without rales, wheeze or decreased breath sounds.  Chest X-ray was consistent with right middle lobe atelectasis versus pneumonia.  His white blood cell count was 13.8 with 76 percent neutrophils.  The subject had a significant anion gap (metabolic acidosis), and negative rapid tests for RSV, influenza, and rotavirus.  The subject received normal saline bolus, a dose of Rocephin, and was admitted for intravenous hydration and observation.  The subject had an unremarkable hospital course, was able to tolerate food without emesis or diarrhea, and was discharged the following day, 26-Dec-2007.  The subject was discharged on Azithromycin and topical drugs for his glaucoma.  The discharge diagnoses were severe dehydration with anion gap metabolic acidosis, and pneumonia.  No further details of the outcome for the events were provided by the reporter.  Rechallenge is not applicable to this adverse event.  The reporting physician assessed the events as not related to FluMist.					Y	1			U	11/29/2007	12/10/2007	11	CXR, 12/25/07, atelectasis vs. pneumonia; rapid test, 12/25/07, neg for RSV, influenza, rotavirus; WBC, 12/25/07, 13.8 with 76% neutrophils	UNK	UNK	Concomitant Drug(s) Not Reported		Past Disease: Congenital glaucoma; cataracts; adrenal insufficiency		MEDI0006489	1						1	Chest X-ray abnormal; Cough; Dehydration; Diarrhoea; Dyspnoea; Exposure to communicable disease; Influenza serology negative; Metabolic acidosis; Mucosal dryness; Neutrophil percentage increased; Oral intake reduced; Pneumonia; Pyrexia; Respiratory tract congestion; Rhinorrhoea; Rotavirus test negative; Urine output decreased; Virus serology test; Vomiting; White blood cell count increased	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0305226	02/15/2008	KY	4.0			U	01/15/2008	A non-serious report of expired FluMist administered was received from a nurse concerning a four-year-old unreported gender.  This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  No medical or drug history was reported.  The patient received FluMist on 02-Jan-2008.  The product had an expiration date of 27-Dec-2007.  Follow-up twelve days after the FluMist dosing, the child had not experienced any adverse event.  A follow-up call to the reporter on 22-Apr-2008 confirmed that the patient did not experience any adverse events. The event was resolved. The reporter did not provide a causality assessment.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Additional information received on 22-APR-2008 and incorporated in above narrative: reporter confirmed patient had no adverse event.									Y	01/02/2008	01/02/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0006358	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500489P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0305227	02/15/2008	PA				U	01/11/2008	A non-serious report of expired dose administered has been received from a nurse concerning a child of unknown age. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 11-Jan-2008. The FluMist that was administered on 11-Jan-2008, had expired the day prior to administration on 10-Jan-2008. No adverse events were reported at the time of the report. No adverse events were reported when the office was contacted on 08-Feb-2008. The Office Manager stated that the expired FluMist was given because the nurse did not check the expiration date prior to administration. The event is considered resolved. The patient did not experience a rechallenge while receiving the suspect product. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to MEDI-0006413, the other case submitted by the same reporter.									Y	01/11/2008	01/11/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0006394	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500479P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0305228	02/15/2008		4.0			M	01/22/2008	A non-serious event of expired product administered was received from a nurse concerning a four-year-old male coincident with FluMist therapy.  This case is submitted in accordance with MedImmune post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  No medical or drug history was provided.  FluMist was administered on 10-Jan-2008.  The FluMist expired ten days earlier on 31-Dec-2007.  Follow-up twelve days later revealed that the patient experienced no ill effects post exposure to the expired FluMist.  No additional dosing is indicated.  The reporter did not provide a causality assessment.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	01/10/2008	01/10/2008	0		UNK	UNK	Concomitant Drug(s) Not Reported				MEDI0006397	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500490P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0305229	02/15/2008	PA	4.0			F		A nonserious report of expire dose of vaccine administered has been received from a nurse concerning a four year-old female patient.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  Neither medical history no concomitant medications were provided.  The patient received FluMist on 24-Jan-2008.  The FluMist had expired on 10-Jan-2008.  At the time of the report, no adverse events were reported from this error.  Rechallenge is not applicable.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	01/24/2008	01/24/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0006505	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0305285	02/15/2008	PA				U	01/11/2008	A non-serious report of expired dose administered has been received from a nurse concerning a child of unknown age and gender. This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 11-Jan-2008. The dose of vaccine that the patient received on 11-Jan-2008 had an expiration date of 10-Jan-2008. No events were reported at the time of the report. Upon follow-up, the Office Manager reported that no adverse events had developed as of 08-Feb-2008. The event resolved. The patient did not experience any rechallenge while receiving the suspect product. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Additional information received 08-Feb-2008 and incorporated into the narrative no adverse events had been reported. This case is limited to MEDI-0006394, the other case from the same reporter.									Y	01/11/2008	01/11/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported		NI		MEDI0006413	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500470P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0305075	02/18/2008	TX	18.0	18		M	02/14/2008	Initial report was received from a physician on 11 February 2008. An 18-year-old male patient with no past medical history, had received an injection of Menactra, lot number U2391BA (route/site not reported), and an injection of Hepatitis A vaccine, lot number U2598 (manufacturer Merck, route/site not reported), and a dose of FluMist, manufacturer Wyeth (lot number not reported), on 07 January 2008 and approximately one to two weeks later, he complained of a headache and began loosing his vision. He was diagnosed by an ophthalmologist as having optic neuritis and began receiving corrective treatment with high dose steroids. At the time of the report, the patient had not recovered from the event. No further information was provided.  02/20/2008 MR received from PCP which included vax record and WCC of 1/7/08. Record is somewhat illegible.  F/U TC 2/12/08 with DX of optic neuritis made by another MD (ophthamologist). 06/04/2008 MR received from ophthamolgist beginning 02/05-28/2008 with DX: Optic Neuritis.  Pt presented with c/o foggy vision, eye pain and H/A which started after immunizations. Swollen nerves noted on exam. Return visit 2/8/08 with worsening vision and H/As. Tx with steroids. Disc edema bilaterally noted on photography of fundus. Improvement noted by 2/28/08.				Y					N	01/07/2008	01/15/2008	8	None reported. Labs and Diagnostics: LP with 35 WBCs, 87% Lymphs, 7 polys, 6 monos.  CSF protein and glucose normal at 42 and 63. CSF Albumin, IgG, IgA, IgM all WNL. Myelin Basic protein 3.4. No oligoclonal bands. CSF cx (-).	UNK	UNK			The patient had no illness and it was unknown if they had been taking any concomitant medications at the time of vaccination. The patient had no known drug allergies and no past medical history.		200800460	1						1	Blindness; Headache; Optic neuritis; Blindness; Headache; Ophthalmological examination abnormal; Optic neuritis; Blindness; Headache; Lumbar puncture; Nuclear magnetic resonance imaging normal; Optic neuritis; Vision blurred	FLUN3~MEDIMMUNE VACCINES, INC.~500497P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~MERCK & CO. INC.~U259B~UNK~UN~UN~HEP A (VAQTA)~1|MNQ~SANOFI PASTEUR~U2391B~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~2|HEPA~MERCK & CO. INC.~~2~IM~UN~HEP A (VAQTA)~2|MNQ~SANOFI PASTEUR~~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|FLUN3~MEDIMMUNE VACCINES, INC.~500497P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~3|MNQ~SANOFI PASTEUR~~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~3	USA	Emergency room visit	Influenza
0305091	02/18/2008		52.0	52		F	02/19/2008	We received from a nurse via the Medical Communication the following information on 12 OCT 2007: A 52-year-old woman, born on 11 MAR 1955, was vaccinated with 0.5 ml Fluvirin, batch-no. 80682, i.m. on 10 OCT 2007. In the evening of vaccination day she began to experience abdominal cramping and loose stools. The following day around lunchtime the patient's face became flush, knees, elbows, forearms and mouth became bright red, she experienced burning sensation around mouth and went to Emergency Room where she was believed to be having an allergic reaction. The reported symptoms, except for burning sensation around the mouth, abdominal cramps and loose stools, are expected after vaccination with Fluvirin. On a case level, the case is considered expected. No change in benefit-risk-ratio. No measures necessary. Addendum: We received from the reporting nurse additional information on 06 FEB 2008: The patient is an employee of a hospital. She went to the Emergency Room for evaluation. She indicated at the time that the only thing different that had occurred was that she received the flu vaccine 24 hours earlier. Later she confirmed that the symptoms related to a virus that she had acquired and there is not relationship to the vaccination with Fluvirin.					Y	0			U	10/10/2007	10/11/2007	1		OTH	OTH	No other medications	Unknown			MA20071115	1						1	Abdominal pain; Diarrhoea; Erythema; Flushing; Hypersensitivity; Oral discomfort	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80682~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0302116	02/19/2008	UT	16.0			F	02/14/2008	Information has been received from a newspaper article concerning a 16 year old female who on 06-NOV-2007 was vaccinated with a dose of Gardasil. Three weeks post vaccination, the patient woke up to not being able to walk or feel her legs. The patient was taken to the hospital and admitted with guillain barre syndrome. For four days, the patient was paralyzed from the top of her knee down. Details of hospitalization were not reported. Subsequently, the patient was tired all the time with passing out episodes and not feeling well. The patient's mother reported that the patient underwent 2 MRIs and many blood tests. The treating health care workers are stating that it is stress, and the patient was placed on therapy with PROZAC. At the time of this report, the outcome was unknown. Additional information is not expected.				Y	Y	0			U	11/06/2007	11/06/2007	0	magnetic resonance 2-results not reported; diagnostic laboratory many blood tests	OTH	OTH	Unknown		Unknown	Feeling unwell, Passed Out, Tired all the time~HPV (Gardasil)~UN~13.00~In Sibling	WAES0801USA05963	1						3	Blood test normal; Convulsion; Corrective lens user; Decreased appetite; Diplegia; Dizziness; Fatigue; Fatigue; Headache; Hypersomnia; Hypophagia; Loss of consciousness; Nuclear magnetic resonance imaging normal; Oral mucosal blistering; Sensation of heaviness; Weight decreased; Convulsion; Dizziness; Guillain-Barre syndrome; Hyperventilation; Hypoaesthesia; Laboratory test; Loss of consciousness; Neurological examination; Oropharyngeal blistering; Syncope; Abasia; Blood test; Fatigue; Guillain-Barre syndrome; Hypoaesthesia; Laboratory test; Loss of consciousness; Malaise; Nuclear magnetic resonance imaging; Paralysis; Stress	FLUX~UNKNOWN MANUFACTURER~~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~1426F~1~UN~LA~HPV (GARDASIL)~1|HPV4~MERCK & CO. INC.~~1~UN~UN~HPV (GARDASIL)~2|HPV4~MERCK & CO. INC.~~UNK~UN~UN~HPV (GARDASIL)~3	USA	Hospitalisation	Influenza
0305100	02/19/2008	KS	37.0	37		F	02/15/2008	Information has been received from a 37 year old female registered nurse with multiple sclerosis and allergy to ibuprofen who on 23-OCT-2007 was vaccinated with her first dose of Pneumovax 23, 0.5 ml, IM left deltoid.  Concomitant therapy included FLUZONE, which was given the same day, and BETASERON.  On 23-OCT-2007 the patient experienced erythema, swelling, and pain at the injection site after her first dose of Pneumovax 23.  She also had a fever and was unable to move her arm for three days.  On 07-DEC-2007, she began experiencing pain in her hands and seizures.  She was admitted to the hospital on 09-DEC-2007 and was diagnosed with thrombotic thrombocytopenic purpura.  She was released from the hospital on 08-JAN-2008, and was recovered.  The registered nurse considered thrombotic thrombocytopenic purpura to be disabling, immediately life-threatening and an other important medical event.  Additional information has been requested.  9/2/08 Reviewed hospital medical records of 12/09/07-01/07/2008. FINAL DX: refractory thrombotic thrombycytopenic purpura Records reveal patient experienced HA, numbness of arm & leg, difficulty ambulating, fall, reduced oral intake, decreased vocalization, fever, & confusion worsening over 2 days time.  Seen at outlying ER & transferred to higher level of care.  Admitted to ICU. ID, neuro consult done.   Tx w/plasmapheresis QD during hospitalization.  Also tx w/rituximab x 3 doses & high dose steroids & Imuran.  Treated briefly for presumed UTI.  Developed fever & had partial complex seizures 12/17/07 followed by postictal confusion. Plasmapheresis was increased to BID.  Very gradually improved & d/c to home			Y		Y	29		Y	Y	10/23/2007	10/23/2007	0	LABS: EEG abnormal.  Initial CT of head WNL.  CXR WNL.  MRI brain c/w MS changes.  Initial plts 10 & 146(L) at d/c.  Initial H/H 6.5/18.8(L), segs 74%(H), lymphs 10%(L).  LDH 548(H), total bili 1.6(H).  Cardiolipin IgG 45(H) & IgM 18(H).  All cultures neg.	OTH	OTH	BETASERON	Multiple sclerosis; drug hypersensitivity  On antibiotics for ear infection.	PMH: multiple sclerosis, depression, urinary retention, recurrent UTIs.    Allergic: ibuprofen.		WAES0802USA03150	1						1	Convulsion; Injected limb mobility decreased; Injection site erythema; Injection site pain; Injection site swelling; Pain in extremity; Pyrexia; Thrombotic thrombocytopenic purpura; Injection site erythema; Injection site pain; Injection site swelling; Pyrexia	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U2489AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0697U~1~UN~LA~PNEUMO (PNEUMOVAX)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0305125	02/19/2008	VA	40.0	40		F	02/19/2008	Phone call from client 1/7/08.  Complains of pain @ injection site immediately with vaccine; rested arm for a few days then restarted yoga, stretching & exercising.  Pain has continued & noted some weakness in arm when lifting sideways.  As of 1/24/08, it is still painful but patient has not yet been to MD.									U	11/06/2007	11/06/2007	0		UNK	UNK		none	none		VA08002	1						1	Immediate post-injection reaction; Injection site pain; Muscular weakness	FLU3~SANOFI PASTEUR~U2523AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0305133	02/19/2008	NY	44.0	44		M	02/19/2008	Employee reports that following his tetanus vaccination in November, he developed pain and impaired range of motion/function to his left arm. Symptoms developed approximately 1 week after the injection, which was administered on 11/29/07 in the left deltoid muscle.  At that time, he reports that he noted pain radiating from his left shoulder to his elbow, and his arm was weak.  He states that he had difficulty abducting his left arm, however he was able to move his left shoulder in all other range movements.  He states that he was unable to lift items with his left arm for a period of a few weeks.  He reports that these symptoms have slowly improved over time, and at this time he is able to demonstrate active range of motion to the left shoulder and arm without evidence of limitation.  He states that he currently experiences pain from my shoulder to my elbow when I cough.									U	11/29/2007	12/05/2007	6		UNK	UNK	None	None	None			1						1	Injected limb mobility decreased; Muscular weakness; Musculoskeletal pain; Pain in extremity; Injected limb mobility decreased; Joint range of motion decreased; Muscular weakness; Pain in extremity; Radiculitis brachial	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~08682~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C2769AA~UNK~IM~LA~TDAP (ADACEL)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~08682~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|TDAP~SANOFI PASTEUR~C2769A~UNK~IM~LA~TDAP (ADACEL)~2	USA		Influenza
0305134	02/19/2008	NJ	52.0	52		F	02/19/2008	Quarter size bump at injection site for approx one month, with redness and swelling. Got the flu the 2 days later for 10 days with symptoms of Fever of 102, chills, aches, headache, congestion, sore throat.									Y	10/20/2007	10/21/2007	1		UNK	UNK	none	none	sulfa allergy			1						1	Chills; Headache; Influenza; Injection site erythema; Injection site mass; Injection site swelling; Nasal congestion; Pain; Pharyngolaryngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0305142	02/19/2008	NC	42.0	42		F	02/19/2008	First day severe muscle and joint pain, second day severe neck and head pain, third day progressed to tachycardia and hypertension that required emergency treatment. Day 6 now and still progressive weakness and fever with all the above symptoms as well. Doctor has given steroids to treat reaction. Just started today. Still very sick with increasing severity of symptoms. 3/3/08 records received C/O weakness, fatigue tachycardia, hypertension, as possible reaction to influenza injection. Unable to keep fluids down, treated with IV fluids.				Y						02/13/2008	02/13/2008	0		UNK	UNK			3/3/08-records received-HX of chronic pain syndrome with fatigue.			1						1	Arthralgia; Asthenia; Headache; Hypertension; Myalgia; Neck pain; Pyrexia; Tachycardia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0305153	02/19/2008	PA	27.0	27		M	02/19/2008	This case was reported by a healthcare professional and described the occurrence of fever in a 27-year-old male subject who was vaccinated with influenza vaccine trivalent (Flulaval, GlaxoSmithKline) for prophylaxis. Concurrent medical conditions included attention deficit hyperactivity disorder, autism, bipolar, ocd and oppositional defiant disorder. Concurrent medications included Trazodone, Clonazepam (Clonopin), Lithium carbonate, Mirtazapine (Remeron), Polyethylene glycol (Miralax), Risperidone (Risperdal) and Quetiapine fumarate (Seroquel). On 31 October 2007 the subject received unspecified dose of Flulaval (.5 ml, intramuscular, left arm). On 8 February 2008, 100 days after vaccination with Flulaval, the subject experienced fever and cough. The subject had difficulty breathing and developed influenza type a (vaccination failure). The nurse reported that the subject possibly aspirated because his chest x-ray showed pneumonia on 11 February 2008. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with mechanical ventilation (ventilation) on 12 February 2008. At the time of reporting the events were worse.					Y	0			U	10/31/2007	02/08/2008	100	11 February 2008: Chest x-ray showed pneumonia.	PVT	OTH	Trazodone; Clonazepam; Lithium carbonate; Mirtazapine; Polyethylene glycol; Risperidone; Quetiapine fumarate	ATTENTION DEFICIT HYPERACTIVITY DIS, AUTISM, BIPOLAR, OCD, OPPOSITIONAL DEFIANT DISORDER	The subject has previously received flu shots. There were no adverse events noted with previous flu shots or previous vaccinations.		A0710557A	1						1	Chest X-ray abnormal; Cough; Dyspnoea; Influenza; Mechanical ventilation; Pneumonia; Pyrexia; Vaccination failure	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~RL~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation	Influenza
0305155	02/19/2008	MD	80.0			M	02/19/2008	This case was reported by a physician (also the consumer) and described the occurrence of influenza illness in a male subject aged between 80 and 89 years old who was vaccinated with Flulaval (GlaxoSmithKline). On an unspecified date the subject received 1st dose of Flulaval at 1.0 ml. Four months after vaccination with Flulaval, the subject developed a severe influenza illness. This was considered to be a vaccination failure. This event is medically serious according to GSK. The subject experienced a systemic reaction. There was a concern as to whether or not the medication had been properly stored. It was thought that the vaccine was not kept in the refrigerator. This was considered to be a medication error. At the time of reporting the influenza illness was resolved. The physician considered the events were probably related to vaccination with Flulaval. No additional events were reported.									Y				UNK	OTH	OTH		Unknown	No relevant medical history was reported.  The subject previously received flu shots and no reactions were reported.		A0710304A	1						1	Influenza; Medication error; Nonspecific reaction; Vaccination failure	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~UN~RL~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0305158	02/19/2008	OR	1.3	1	.3	F	02/13/2008	Varivax given right thigh 01 24 08. On 02 07 08 parents reported clear vesicle lesions on right thigh. Seen in clinic that day. No further treatment.				Y					Y	01/24/2008	02/07/2008	14	none	PVT	UNK	None	Eczema	hx mild eczema			1						1	Injection site vesicles	FLU3~SANOFI PASTEUR~UT2477BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C45888~5~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0305160	02/19/2008	WA	37.0	37		F	02/11/2008	Patient stated that left arm was painful >2 wks after injection; Denies local reaction, such as redness, irritation, swelling, fever									Y	01/17/2008	01/17/2008	0	none	PVT	PVT		unknown	unknown			1						1	Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80825~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~SANOFI PASTEUR~U2067BA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0305165	02/19/2008	MN	13.0	13		F	02/11/2008	Large erythematous patch 13cm x 14cm around Varivax site				Y					Y	02/08/2008			None	UNK	UNK		None	No			1						1	Injection site erythema	FLUN3~MEDIMMUNE VACCINES, INC.~500500P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~1446U~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2543AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~1774U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0305175	02/19/2008	WA	32.0	32		M	02/11/2008	Pain in Lt arm >15 days after injection.  Denies redness, swelling, irritation, fever.									Y	01/17/2008	01/17/2008	0	None	PVT	PVT		Unknown	Unknown			1						1	Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80825~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~SANOFI PASTEUR~U2067BA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0305184	02/19/2008	NV	1.2	1	.2	M	02/19/2008	Immunizations given 2/14/08.  2/16 - patient developed 'red spots'.  2/17 - rash itchy, child edematous, taken to hospital.  Diagnosed with hives, given Benadryl.				Y					Y	02/14/2008	02/16/2008	2		PUB	PUB		None	None			1						1	Oedema; Rash pruritic; Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B051AA~5~IM~UN~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2512AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB214AA~2~IM~UN~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0417U~2~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B5401614~5~IM~UN~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1841U~2~SC~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0305629	02/19/2008	ND	18.0	18		F	02/14/2008	Initial and follow up information has been received from a registered nurse (previously reported as a licensed practical nurse) concerning an 18 year old female (previously reported as older female) who was vaccinated in December 2007 (right before Christmas), with the first dose of Gardasil (lot # not reported).  Concomitantly, the patient received influenza virus vaccine (unspecified).  It was reported the patient experienced a whoosh/warm feeling going through her leg, the shot felt uncomfortable and the area was tender.  The nurse stated that within 15 minutes after the vaccination, the patient felt sick with flu-like symptoms, including body aches and malaise, as well as nausea.  It was reported that there were flu symptoms going around the town.  The nurse reported that the symptoms lasted for 1 1/2 days.  It was reported that another patient experienced symptoms after receiving Gardasil, (WAES # 0801USA02008).  Additional information is not expected. This is in follow-up to report(s) previously submitted on 2/14/2008. Initial and follow up information has been received from a registered nurse concerning an 18 year old caucasian female with no pertinent medical history, who was  vaccinated IM in the left thigh, on 18-DEC-2007 at 8:55 am, with the first dose of GARDASIL (lot # 656049/0187U). Concomitantly, the patient received the first dose, IM in the left arm, of influenza virus vaccine (SP, lot #02435AA). There was no illness at the time of vaccination. It was reported the patient experienced a whoosh/warm feeling going through her upper leg, the shot felt uncomfortable and the area was tender. The nurse stated that within 15 minutes after the vaccination, the patient felt sick with flu-like symptoms, including headache and body aches and malaise, as well as nausea. She also reported fatigue and no appetite. It was reported that there were flu symptoms going around the town. The nurse reported that the symptoms lasted for 1 1/2 days, with recovery noted on 20-DEC-2007. It was reported that another patient experienced symptoms after receiving GARDASIL. (WAES # 0801USA02008). Additional information is not expected.									Y	12/18/2007	12/18/2007	0	Unknown	PUB	PUB			None		WAES0801USA02289	1						1	Decreased appetite; Fatigue; Feeling hot; Influenza like illness; Injection site discomfort; Injection site pain; Malaise; Nausea; Pain	FLUX~SANOFI PASTEUR~02435AA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~0187U~1~IM~LL~HPV (GARDASIL)~1	USA		Influenza
0305843	02/19/2008	NE	25.0	25		F	02/14/2008	Information has been received from a physician concerning a 25 year old female who on 17-DEC-2007 was vaccinated with her second dose of GARDASIL. Concomitant therapy included influenza virus vaccine (unspecified) (INFLUENZA VIRUS VACCINE USP). On 17-DEC-2007 the patient experienced dizziness, nausea, nose bleeding and fainted. The patient sought unspecified medical treatment. Subsequently, the patient recovered from dizziness, nausea, nose bleeding and fainting on the same day. The patient did not have an adverse event with the first dose. Additional information has been requested.				Y					Y	12/17/2007	12/17/2007	0	unknown	UNK	UNK			Unknown		WAES0801USA03173	1						1	Dizziness; Epistaxis; Nausea; No reaction on previous exposure to drug; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~2~UN~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0305255	02/20/2008	GA	52.0	52		F	02/20/2008	This case was reported by a physician and described the occurrence of itching in a 52-year-old female subject who was vaccinated with Fluarix (GlaxoSmithKline) for prophylaxis.  On 28 November 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown, right arm).  On 28 November 2007, less than one day after vaccination with Fluarix, the subject experienced itching and generalized rash on multiple body parts.  The subject was treated with Medrol dose pak and Claritin in the physician's office.  At the time of reporting the events were improved.  The physician considered the events were probably related to vaccination with Fluarix.  Follow-up information received on 11 February 2008 indicated that the events resolved by 13 December 2007 and were considered by the reporter to be related to treatment with Fluarix.  The reporter additionally added that the events jeopardized the subject or required intervention (prescription required).  The events did not appear to be an allergic reaction.  At the age of 39, the subject received tetanus toxoid (manufacturer unknown) and became hot, red and swollen at the injection site (necrotic at the center).  The subject was given antibiotic at that time.  Concurrent medications taken at the time of Fluarix vaccination included Toprol, Mobic, Maxide and Aciphex.  Concurrent medical conditions included hypertension, osteoarthritis, peptic ulcer disease and GERD.				Y					Y	11/28/2007	11/28/2007	0	UNK	PUB	PUB	Metoprolol succinate; meloxicam; Maxide; sodium rabeprazole	GASTROESOPHAGEAL REFLUX DISEASE; HYPERTENSION; OSTEOARTHRITIS; PEPTIC ULCER DISEASE	No relevant medical history was reported.  The patient had previously received flu shots.  It was reported the subject had no adverse events with Fluzone in the past.  The subject had no adverse events following receipt of prior immunizations.  A total of three patients had experienced adverse events following vaccination with Fluarix.  See A0698846A and A0698850A.  Follow-up information indicated that at the age of 39, this subject received tetanus toxoid (manufacturer unknown) and became hot, red and swollen at the injection site (necrotic at the center).  The subject was given antibiotic.	hot, red and swollen at the injection site (necrotic at the center)~Tetanus Toxoid (no brand name)~UN~39.00~In Patient	A0698853A	1						1	Pruritus; Rash generalised	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0305258	02/20/2008	GA	78.0	78		F		1/5/08 Legs gave way and she fell several times right together. Legs hurt and didn't have any strength in them. 1/8/08 Diagnosed with Guillain-Barre Syndrome (Admitted to hospital and stayed 5 days. Received intravenous immunoglobulin(s). 2/26/08-records received for DOS 1/8-1/13/08- DC DX: Guillain-Barre syndrome. One week prior became extremely weak and started to fall serveral times per day. On exam found to have areflexic partial lower extremity paraparesis. Ataxic. Treated with 5 days gamma globulin.  02/05/2010 Follow up: She still has pain and tingling in her legs and they are still weak.					Y	5			N	11/15/2007	01/05/2008	51	2/25/08-Nerve conduction studies showed findings consistent with acute demyelinating polyneuropathy. Lumbar puncture protein 33 glucose 66. CSF culture and gram stain negative. CBC and basic metabolic profile unremarkable. Thyroid mildly elevated TSH 8.9.Negative west nile, lyme titers.	PUB	UNK		ASHD with HTN	2/25/08-PMH:hypertension, inner ear disorder and vertigo.			1						1	Fall; Guillain-Barre syndrome; Muscular weakness; Pain in extremity; Pain in extremity; Paraesthesia; West Nile virus test negative	FLU3~SANOFI PASTEUR~2529AA~4~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0305269	02/20/2008	PA	3.0	3		M	02/19/2008	2/7/08-4pm-Injection site became red (when mom noticed) - large area of erythema, about 3x3 in. - warm to touch - no fever - Rx with Cephalexin 250 mg tid x5 days.  Area was all clear within couple days.				Y					Y	02/06/2008	02/07/2008	1		PVT	PUB		None				1						1	Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U2502AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0306138	02/20/2008	PA	0.63	0	.6	F	02/18/2008	Information has been received from a nurse concerning a 7 month old female with no pertinent medical history or drug reactions or allergies who on 15-NOV-2007 was vaccinated intramuscularly with a 0.5ml dose of PEDVAXHIB (OMPC) (lot # 654072/1013F).  Concomitant therapy included DAPTACEL and FLUZONE (influenza virus split virion 3v vaccine inactivated), date received was not specified.  On 15-NOV-2007, 12 hours post vaccination, the patient developed a fever and had a febrile seizure.  The patient was taken to the emergency room and later released.  No lab diagnostic test were performed.  The patient recovered on 16-Nov-2007.  Upon internal review, the patient's febrile seizure was considered an other important medical event.  Additional information has been requested. This is in follow-up to reports previously submitted on 2/28/2008. Information has been received from a nurse concerning a 7 month old female with no pertinent medical history or drug reactions, allergies or illness at time of vaccination who on 15-NOV-2007 at 9:00am was vaccinated intramusculary in the right lower thigh with a third 0.5ml dose of Hib conj vaccine (lot # 654072/1013F). The patient was concomitantly vaccinated on the same day with DAPTACEL -lot# C2569AA given intramuscularly in the right upper thigh and FLUZONE - lot# UT2460AA intramusculary in the left thigh. On 15-NOV-2007 at 9:00pm. 12 hours post vaccine the patient developed a fever and had a febrile seizure. The patient was taken to the emergency room and later released. No lab diagnostic test were performed. The patient recovered on 16-NOV-2007. Upon internal review, the patient's febrile seizure was considered an other important medical event. No additional information is expected.				Y					Y	11/15/2007	11/15/2007	0	None	PVT	PVT			None		WAES0711USA04170	1						1	Febrile convulsion	DTP~SANOFI PASTEUR~C2589AA~3~IM~UN~DTP (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~UT2460AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1013F~UNK~IM~UN~HIB (PEDVAXHIB)~1	USA	Emergency room visit	Influenza
0306334	02/20/2008	VA	1.0	1	.0	F	02/18/2008	Information has been received from a consumer and follow up from a medical assistant concerning a 12 month old white female with no pertinent medical history, drug reactions/allergies or illness at time of vaccination, who on 30-NOV-2007 was vaccinated intramuscularly (site not reported) with the third (also reported as fourth dose) 0.5ml dose of PEDVAXHIB (OMPC) (lot #656522/0437U).  On the same day the patient was concomitantly vaccinated intramuscularly with a fourth dose of PREVNAR (lot # B54015D) and FLUZONE (influenza virus split virion 3v vaccine inactivated) (lot #UT2460BA).  Subsequently starting on 13-Dec-2007 at 11:30am, the patient experienced 4 incidents of vomiting (previously reported as 3).  The patient was very sick to the stomach and had nausea during the following week.  The patient did not receive medical attention and no diagnostic lab test were performed.  On 20-Dec-2007, the patient recovered.  No additional information is expected.									Y	11/30/2007	12/13/2007	13	None	PVT	PUB			None		WAES0712USA06503	1						1	Nausea; Stomach discomfort; Vomiting	FLU3~SANOFI PASTEUR~UT2460BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0437U~4~IM~UN~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B54015D~4~IM~UN~PNEUMO (PREVNAR)~1	USA		Influenza
0306434	02/20/2008	MI	4.0			F	02/18/2008	Information has been received from a grandmother concerning her 4.5 year old granddaughter with no reported allergies or medical history who on approximately 26-NOV-2007, three weeks ago, was vaccinated IM in the leg with a 0.5 mL dose of PedvaxHIB. Concomitant therapy included vaccination with a dose of influenza virus vaccine (unspecified) in the opposite leg. On approximately 26-NOV-2007, the same day as the vaccination, the patient's leg that was vaccinated with PedvaxHIB became all red and hard as a rock for two weeks. The patient sought unspecified medical attention. On approximately 17-DEC-2007, just this week, the patient developed an uncontrollable fever and blisters inside her mouth. The patient was brought to the emergency room and was treated with unspecified antibiotics and pain medication. The patient was not admitted to the hospital. At the time of this report, the patient was recovering. Additional information has been requested.				Y					N	11/26/2007	11/26/2007	0	Unknown	OTH	OTH			None		WAES0712USA07913	1						1	Erythema; Induration; Oral mucosal blistering; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~MERCK & CO. INC.~~UNK~IM~UN~HIB (PEDVAXHIB)~1	USA	Emergency room visit	Influenza
0305335	02/21/2008	NY	67.0	67		F	02/19/2008	Initial report received on 07 February 2008 from a health care professional. A 64-year-old female patient, with a past medical history of diabetes and unspecified neck surgery, had received a left deltoid, intramuscular injection of Fluzone SV 2007-2008, lot number U2486AA, on 16 January 2008. The patient had been administered the last dose from a ten dose vial. (It was the reported that the nine previous patients had experienced no symptoms.) The patient had no illness at the time of vaccination. Two days post-vaccination, the patient developed a fever of 105 degrees Fahrenheit and pain high on the left side of the neck with redness that spread to the shoulder. There was no reaction at the injection site. She was examined in an emergency room and subsequently admitted to the hospital with the admitting diagnosis of sepsis from inoculation. WBC was 35,000. Unspecified CT scan and chest x-ray were negative. Neck x-ray showed old post-surgical changes with a reactive lymph node on the left side. The patient was treated with five days of antibiotics and improved. She was discharged to home. The day following discharge, she was examined by a physician and was continuing to complain of left sided neck pain, generalized weakness, and tenderness and numbness of the sternum. She was treated with Keflex and was scheduled for a bone scan to rule out osteomyelitis. At the time of this report, the patient had not recovered.					Y	0			N	01/16/2008	01/18/2008	2		PVT	PVT	LOBI, CYMBALTA, DIOVAN, AMITRIPTYLINE, ZANICAL, PREMARIL, GLUMATARID, NEXIUM		The patient had a history of diabetes, hypertension, hyperlipidemia, goiter, GERD, and neck surgery.		200800427	1						1	Asthenia; Chest X-ray normal; Computerised tomogram normal; Erythema; Hypoaesthesia; Musculoskeletal pain; Neck pain; Pain; Pyrexia; Sepsis; Spinal X-ray; Tenderness; White blood cell count increased	FLU3~SANOFI PASTEUR~U2486A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0305342	02/21/2008		4.0	4		F	02/21/2008	Pt received MMR in lateral (R) thigh, developed a red, raised welt at the injection site after 25 minutes. Mother states three days elapsed before swelling started to go down, although Motrin given and cold packs applied. Bruised appearance at the site did not begin to resolve until 12 Feb 08.									Y	02/01/2008	02/01/2008	0	None	MIL	MIL	NONE	NONE	DAIRY	SEIZURE~Measles + Mumps + Rubella (no brand name)~1~1.00~Sibling		1						1	Injection site bruising; Injection site erythema; Injection site urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~MERCK & CO. INC.~0527U~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0305343	02/21/2008	MN	94.0	94		F	02/21/2008	Erythema, swelling and pain at injection site.									U	02/19/2008	02/20/2008	1	n/a	UNK	UNK	acetaminophen, allopurinol, amlodipine, aspirin, benzonatate, os-cal + D, citalopram, cyanocobalamin tablet, docusate sodium, ergocalciferol, Primaxin, Imdur, Toprol XL, Micro-K capsule, Prenatal RX, trazodone, ocuvite	gastroenteritis	Penicillins, morphine, Dilaudid, Vicodin, heparin agents, Lipitor, Plavix, Ticlid, Levaquin, Keflex, atenolol			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~unknown~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~unknown~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0305346	02/21/2008	VI	77.0	77		F	02/21/2008	Client came by clinic to update our medical records that she received pnuemonia vaccine in 2004.  Told nurse that she is in therapy for left shoulder pain that began 1 week after receiving flu shot in Dec 07. Is being followed by physician in clinic as well as orthopedic physician.  Has had flu vaccines from another provider in previous years.									U	12/27/2007	01/07/2008	11	unknown	PUB	PUB	meds for Hypertension, diabetes (oral meds, cholesterol, arthritis	none	none			1						1	Musculoskeletal pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80687~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0305348	02/21/2008	PA	6.0	6		F	02/21/2008	Hep A, Influenza   Complaints of increased temps over 11 days afer vaccines.  Persistent headaches starting 2 days after vaccine to her reporting to us on 2/19/2008.  Bilateral arm pain as 2 vaccines received.				Y					U	02/07/2008	02/09/2008	2	Unknown, patient was told to be seen by a doctor. We are a immunization clinic only.	UNK	UNK	None	None	None			1						1	Body temperature increased; Headache; Pain in extremity	FLU3~SANOFI PASTEUR~U2461DA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB215AA~2~IM~LA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0305370	02/21/2008	NY	8.0	8		F	02/13/2008	Patient received flu vaccine for the 1st time 2/11/08 and varicella #2 on same date.  On 2/12/08 she developed urticaria all over the body.  She ate Cheerios 2/11/08 night & 2/12/08 ate chicken, mac & cheese, apple & corn.  No egg allergy.  Treatment: Benadryl elixir, prednisolone.				Y					Y	02/11/2008	02/12/2008	1		PUB	PUB		None	None			1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~U2476GA~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARCEL~MERCK & CO. INC.~1359U~2~IM~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0305372	02/21/2008	VA	1.3	1	.3	M	02/21/2008	Fever with tonic clonic seizures lasting 30 seconds and occurring at 3 AM on November 14, 2007.  Paramedics were called to the house, child recovered, advised follow up.									Y	11/13/2007	11/14/2007	1	None	MIL	MIL	Vanicream	None	None			1						1	Grand mal convulsion; Pyrexia	FLU3~SANOFI PASTEUR~U2516AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0500U~2~IM~LL~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~1470F~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08700K~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0305375	02/21/2008	NC	33.0	33		F	02/12/2008	I am submitting this VAERS report in the possibility that others may benefit from the information I am providing. As one of the Influenza Vaccine Nurses, I administered several hundred influenza vaccines to both children and adults between the dates of 29 Oct through 14 December, 2007. Shortly following the administration of the vaccines I became sick with flu like symptoms. I initially tried to self treat myself with Tylenol and over the counter cold/flu medications, as I felt sure what I had was viral. My initial symptoms were headache, mild fever, and an achy feeling all over. These symptoms persisted for more than a week and were later followed by a bronchitis type cough and a sinus infection. I saw the physician on December 3, 2007 and was given some antibiotics for an upper respiratory infection. Currently, I still have the cough and sinus symptoms despite having been treated. There were two other nurses at our hospital facility that administered hundreds of influenza vaccines and experienced some of these same type symptoms.				Y					Y	10/29/2007	11/18/2007	20		MIL	MIL	N/A	None				1						1	Cough; Headache; Influenza like illness; Pain; Pyrexia; Sinusitis; Upper respiratory tract infection	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA040AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0305376	02/21/2008	NC	49.0	49		F	02/08/2008	See attached write-up				Y					Y	10/29/2007	11/18/2007	20	Chest X-ray x 2 - clear; Pulse oximetry 92% x 1	MIL	MIL		None	Seasonal allergies, Anemia			1						1	Chest X-ray normal; Oxygen saturation; Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA040AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0305377	02/21/2008	NC	54.0			F	02/09/2008	I am submitting this VAERS report in the possibility that others may benefit from the information I am providing.  As one of the vaccine nurses at the hospital, I administered several hundred influenza vaccines to both children and adults between the dates of 29 Oct through 14 December, 2007.  Shortly following the administration of the vaccines I became sick with flu like symptoms.  I initially tried to self treat myself with Tylenol and chicken soup, as I felt sure what I had was viral.  My initial symptoms were headache, mild fever, and an achy feeling all over.  These symptoms persisted for more than a week and were later followed by a bronchitis type cough and lung pain on inspiration.  I saw the physician on November 26th and was given some antibiotics for my bronchitis.  However, my lung x-rays appeared normal.  Now 4 months later I continue to feel fatigued with mild reactive airway type symptoms.  In addition, I had a Respiratory Viral Panel done in January that did not show any respiratory, or influenza virus.  However, that test was frozen and mailed out late.  There were two other nurses at our hospital facility that administered hundreds of influenza vaccines and experienced some of these same type symptoms.  Therefore, their VAERS Report and statements are included in this envelope.  Please do not hesitate to call me should you have further questions, or concerns.  The vaccines I administered are as follows: FluMist Manufacturer MedImmune Inc Lot 500488P Exp Dec 25, 07; FluLaval Manufacturer GlaxoSmithKline Lot AFLLA040AA Exp July 08; Flu Zone Manufacturer Sanofi Pasteur Lot U2490AA Exp 30 Jun 08.  When trying to complete PDF VAERS Form on the computer it appeared to be a read only.  Therefore, completed by hand.				Y					Y		11/11/2007		X-rays lung normal	MIL	MIL	None	None	Hypertension; Diabetes			1						1	Bronchial hyperreactivity; Bronchitis; Chest X-ray normal; Cough; Fatigue; Headache; Influenza like illness; Lung disorder; Pain; Pyrexia; Virus culture	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA040AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0305379	02/21/2008	MI	0.54	0	.5	F	02/12/2008	No adverse events.  Pt received 2 doses of Hep B.										01/29/2008				PUB	PUB						1						1	Inappropriate schedule of drug administration; No adverse reaction	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B127AA~2~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~LLT2459PA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0011F~2~IM~LL~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~870145B~2~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0305381	02/21/2008	HI	44.0	44		M	02/10/2008	Pt. received FluMist on 1 Dec 2007.  MedImmune, Inc., Lot #500501P, 0.25 mL intranasal.  L nostril congested receiving FluMist.  Had to call in sick from work for 3 days last week Dec.  Saw an MD; was prescribed antibiotics.  Took all antibiotics w/ no relief of nasal congestion. Pt. also c/o HA, increased runny nose, difficulty breathing at night, increased snoring.  Pt. taking loratadine OTC x1 tab QD.				Y					N	12/01/2007			None	MIL	MIL	Aspirin baby aspirin PRN HA and Tylenol tab 650 mg PRN HA, up to 6 Tylenol QD	No	No			1						1	Activities of daily living impaired; Dyspnoea; Headache; Nasal congestion; Rhinorrhoea; Snoring	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0305384	02/21/2008	IN	0.53	0	.5	M	02/21/2008	Had shots in AM.  Had seizure around 9pm - called 911.  Went to hospital - noted he had fever to 101.  Cousin also has hx of febrile seizures.				Y					Y	01/03/2008	01/03/2008	0		PVT	PUB	Tylenol	Mild cold/wheezing		fever~Vaccine not specified (no brand name)~1~0.20~Patient		1						1	Convulsion; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B124CA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~AVENTIS PASTEUR~U2502AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0498U~2~IM~LL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~054013H~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1244U~2~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0305395	02/21/2008	NE	7.0	7		F	01/20/2008	Wheezing and redness of face shortly after vaccines given.  Treatment - Epi-Pen, Benadryl, Prednisone.				Y					Y	12/21/2007	12/21/2007	0	None	PVT	PVT	None	None	Reactive Airway Disease	Hives~Measles + Mumps + Rubella (MMR I)~5~4.00~In Patient		1						1	Erythema; Wheezing	FLU3~SANOFI PASTEUR~U2514AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1343U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0305402	02/21/2008	IL	43.0	43		F	02/21/2008	Patient received flu shot 10-29-07.  On 2-6-08 patient called me to complain her arm was still sore.  She has noticed loss of strength.  She said she tried both IBU and APAP.  She said she does not have PCP to follow up with, even though I referred her to her MD.									N	10/29/2007				OTH	PVT						1						1	Asthenia; Pain in extremity	FLU3~SANOFI PASTEUR~U2499AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0305075	02/22/2008	TX	18.0	18		M	02/21/2008	Information has been received from a physician concerning an 18 year old male with obesity and no drug allergies who in approximately 2004 and 07-JAN-2008 was vaccinated IM with his first and second 0.5 ml doses of Vaqta.  Concomitant vaccinations administered on 07-JAN-2008 included a dose of FluMist and a dose of MENACTRA.  In January 2008, the patient was having symptoms of blindness.  On approximately 14-JAN-2008 a week after administration the patient began to experience headaches and a few days later, the patient could not see.  The patient sought medical attention through an ophthalmologist and a neurologist.  At recent appointments the patient could not read the largest letter on the reading chart and prior to this point the patient had 20/20 vision.  It was noted that the patient was believed to have optic neuritis.  The patient was treated with a course of steroids and his headaches have gotten better since initiating treatment, but his vision has not.  The patient was under the care of a neuro-ophthalmologist at the time of this report and was not recovered.  There was no product quality complaint.  The events were considered to be disabling by the reporting physician.  Additional information has been requested.				Y				Y	N	01/07/2008			ophthalmological exam 01/??/08 - could not read chart; ophthalmological exam 20/20	OTH	OTH		Obesity			WAES0802USA02831	1						2	Blindness; Headache; Optic neuritis; Blindness; Headache; Ophthalmological examination abnormal; Optic neuritis; Blindness; Headache; Lumbar puncture; Nuclear magnetic resonance imaging normal; Optic neuritis; Vision blurred	FLUN3~MEDIMMUNE VACCINES, INC.~500497P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~MERCK & CO. INC.~U259B~UNK~UN~UN~HEP A (VAQTA)~1|MNQ~SANOFI PASTEUR~U2391B~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~2|HEPA~MERCK & CO. INC.~~2~IM~UN~HEP A (VAQTA)~2|MNQ~SANOFI PASTEUR~~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|FLUN3~MEDIMMUNE VACCINES, INC.~500497P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~3|MNQ~SANOFI PASTEUR~~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~3	USA	Disabling	Influenza
0305455	02/22/2008	GA	0.8	0	.8	M	01/16/2008	Mother states that baby was fine with no fever after immunizations until midnight 11/2/07.  Had been giving Tylenol q 4 hrs since immunization.  Baby woke up for a bottle and temp was 105 axillary.  Took child to ER.  According to ER record temp was 100.1 rectally on arrival.  Was told to continue Tylenol & follow-up with PMD next day.  Was ok next day.				Y					Y	11/01/2007	11/02/2007	1		PUB	PUB	None	None	None	No~ ()~~0.00~In Patient	GA08006	1						1	Body temperature increased	FLU3~SANOFI PASTEUR~UT2459NA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0608F~3~IM~RL~HEP B (RECOMBIVAX HB)~1	USA	Emergency room visit	Influenza
0305459	02/22/2008	CA	34.0	34		M	02/06/2008	(6:55 pm) feels nauseated.  Dizzy 15 minutes after.  Also took a WAL-ZYR (5 minutes after the flu shot).  BP went down from 150/80 at 6:45 pm to 130/80 (7:25 pm) after 30 minutes. Pt seemed normal after that.									Y	02/06/2008	02/06/2008	0		OTH	PVT		Mild allergy; cough				1						1	Blood pressure decreased; Dizziness; Nausea	FLU3~SANOFI PASTEUR~U2528AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0305463	02/22/2008	OH	2.0	2	.1	M	02/22/2008	Mom phoned to advise that rash of small red dots on child's wrists appeared 1/24/08 and continued to progress to full body rash over next 2 days, then redness, swelling of hands.  Seen by private MD 1/30 advised measles.  By 2/7 rash faded, hands and feet peeling with cracked skin.  On 2/8 second rash, blistery with fluid filled areas appeared, crusted & scabbed in 1-2 days.  No fever reported through all rashes.  Not seen by MD after 2nd rash developed.				Y					Y	01/18/2008	01/24/2008	6		UNK	UNK		NONE	NONE			1						1	Blister; Erythema; Oedema peripheral; Rash generalised; Scab; Skin exfoliation	DTAP~SANOFI PASTEUR~U1774BA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2474BA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0288U~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PPV~PFIZER\WYETH~B54013D~1~IM~RL~PNEUMO (PNU-IMUNE)~1|VARCEL~MERCK & CO. INC.~1469U~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0305469	02/22/2008	AZ	38.0	38		F	02/22/2008	Two weeks after receiving the flu vaccine, I lost feeling in my right leg, had severe headaches above my right eye, tremors, fatige. After three (confirmed) years of tests, I was diagnosed with ADEM. I had NO prior problems before the vacination. I now have a lesion on my optic nerve, and my vision in my right eye is 20/100 (and was perfect before the shot).  My left eye/side of my body remain normal. I underwent three years of MRI's, spinal taps, dozens of eye tests/ coordination tests/etc... I was unable to continue with my teaching career and have only worked (substituted) a few days since the vaccine was given to me.  I take pain medication as needed for eye/leg/pain.  I am unable to springboard dive (my sport of choice since I was nine).  I was the diving coach for the local high-school prior to getting ADEM. My treatment is:  Live with it. 3/5/08-records received-2/11/04-C/O fatigue, chills, fevers, sweats, loss of appetitie, sedation, weight gain/loss, insommis. Blurring, double vision, vision loss, eye pain, light sensitivity. 3/11/04-C/O tremor left hand, twitching of eye, mild numbness and tingling in legs. Assessment:optic neuritis.  10/29/04-loss of vision right eye. 5/9/05-neurologic exam unable to identify localizing symptoms. Testing negative.  6/14/05-Impression right trigeminal neuropathy.  02/05/2010 Dx: ADEM (Accute Dissemenating Encephalomyelitis). Eye pain, loss of vision in right eye, right leg/arm pain, extreme fatigue.				Y				Y	N	10/22/2003	11/06/2003	15	MRIs show lesions on the brain stem and optic nerve (not previously there).  Final diagnosis after more than three years of testing is ADEM 3/4/08-records received-MRI one small area of abnormality in midbrain. Lyme titer negative. EMG normal.	UNK	UNK	Klonopin, Prozac (for anxiety)	none	none 3/4/08-records received-PMH: frequent sinus congestion. Mitral valve prolapse. Hashimoto's thyroiditis.			1						1	Eye pain; Fatigue; Headache; Hypoaesthesia; Hypokinesia; Lumbar puncture; Nuclear magnetic resonance imaging abnormal; Optic nerve disorder; Pain in extremity; Paraesthesia; Tremor; Visual acuity reduced	FLUX~UNKNOWN MANUFACTURER~?????????????~2~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0305478	02/22/2008	FL	1.03	1	.0	F	02/22/2008	2/11/08 patient received MMR, Hep A, Varicella and Flu shot. On 2/19 symptoms of rash began at the head with purple lips.  Rash began moving down the rest of the body with fever of 101+.  On 2/20 she had a fever of 105.2 and rash fully covered body. On 2/22 she is having difficulty breathing...went to the doctor and was told that this will run its course and to give her Motrin.  Benedryl has not helped at all.				Y					U	02/11/2008	02/19/2008	8		UNK	UNK		Ear Infection				1						1	Cyanosis; Dyspnoea; Pyrexia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~UNK~~~VARICELLA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0305480	02/22/2008	PA	0.88	0	.9	M	02/22/2008	He had a low grade fever for the first couple of days and was very fussy when he was normally a very laid back baby. He stopped babbling and stopped saying Muma and Dada, which he had been for a couple of months. He stopped looking us in the eye, and then started banging his hand on the high chair for an hour to two hours if we let him. He was no longer interested in his rattles and teethers and started rocking back and forth for hours. We thought it might be a long term problem but were assured by the clinic staff that those are not symptoms of a problem, but we NEVER had those symptoms before these last vaccines. He slowly came out of it, as we refused any more vaccinations, and kept talking to him. We will no longer vaccinate for fear of a more long term reaction.									U	12/23/2005	12/23/2005	0	I put unknown under #9, patient recovered, because I am not sure if he will have any long term reactions or illnesses that will show up later in life.	UNK	UNK	None	No	None			1						1	Abnormal behaviour; Aphasia; Head banging; Irritability; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~0~3~UN~UN~DTAP + HEPB + IPV (PEDIARIX)~1|FLUX~UNKNOWN MANUFACTURER~1~1~UN~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~0~3~UN~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0305487	02/22/2008	NY	20.0	20		F	02/22/2008	This case was reported by a healthcare professional and described the occurrence of influenza type a in a 20-year-old female subject who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  The subject's medical history included diabetes.  Concurrent medications included Insulin.  On 15 November 2007 at 10:45 the subject received unspecified dose of Flulaval (.5 ml, unknown, left arm).  On 11 February 2008, 88 days after vaccination with Flulaval, the subject experienced high fever, cough and achiness.  On 13 February 2008, the subject tested positive for influenza A antigen and she experienced a vaccination failure.  This case was assessed as medically serious by GSK.  The subject was treated with oseltamivir phosphate (Tamiflu).  At the time of reporting the events were unresolved.  The nurse stated that she felt the causality for Flulaval causing the adverse event is unknown.				Y					N	11/15/2007	02/11/2008	88	Body temperature increased 11Feb2008 high; Positive for influenza A antigen.	PVT	PVT	Insulin	Unknown	Diabetes - The subject had previously received influenza vaccinations and had not experienced any adverse events following these vaccinations.  The nurse also commented that 2-3 patients who received Flulaval in the Fall tested positive for influenza A antigen in the last week or two.  She did not have the specific number of subjects or demographics for these subjects but did state they received Flulaval from the same lot number as the subject of this case.  See GSK case number A0711167A for details.  She also reported that over the years she had seen subjects develop the flu even after receiving the flu vaccine but she had no specifics on these subjects nor which vaccine they received.  See GSK case number A0711172A for details.		A0711044A	1						1	Body temperature increased; Cough; Influenza; Influenza serology positive; Pain; Pyrexia; Vaccination failure	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA024AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0305504	02/22/2008	TX	23.0	23		M	02/20/2008	Healthy 24 year old preparing for deployment. Symptom onset on 31 Oct 2007 (within 24 hours post-vaccinations: Pan at AVA vaccination site, nausea, diarrhea (every time he ate it 'went through' him). Presenting complaint to Clinic on day 16 post-vaccination: 2 week history of abdominal cramping and diarrhea. Diagnosed as gastroenteritis and treated with IVFs, Bentyl, Lomotil, Acidophilus. Temporarily felt better after taking meds, but symptoms returned after 2-3 hours. Admitted to hospital with Diagnosis: Infectious Colitis secondary to C. diff, LUE. Admission date: 26 Nov 2007, Discharge Date: 18 Dec 2007. Upon discharge, symptoms had improved but not completely resolved. Worsened in early Jan and patient re-admitted on 5 Jan with discharge on 5 Feb. Working dx is inflammatory bowel disease and pt was discharged on oral steroids.  3/7/08 Received hospital medical records for 11/26-12/18/2007 admission which reveal: FINAL DX: infectious collitis secondary to c. difficile secondary to debilitated immunity; RUE thrombophlebitis. HPI: Patient experienced bloody diarrhea x 1 mo w/pain & abdominal cramping.  Patient passed out & came to ER.  Tx w/IVF, IV & oralantibiotics.  GI & ID consults done.  PICC line inserted for IV/TPN nutrition but removed due to basilic vein thrombophlebitis.  Gradually improved & d/c to home w/GI clinic f/u. 1/20/2010 SCE ECDE rolo with Biopsy ripoas -FBS 09 02/05/2010 Diagnosed with Ulcerative Colitis.					Y	51			N	10/30/2007			C diff (Toxin A), 11/26/07, positive; 12/11/07, positive (2nd specimen obtained at 2215 on 12/11/07 was NEG); 12/17/07, NEG; 12/31/07, NEG; labs, 13 Jan 2008, pathology report, hospital; SPECIMEN Rectosigmoid, R) and L) Colon Biopsies, all three specimens show an active colitis with the left and rectosigmoid colon biopsies showing a moderate degree of activity while the right shows a more mild degree, however all pieces in all of the biopsies are affected and there are few foci of surface exudate, the overall appearance suggests an infectious colitis; the possibility of ulcerative colitis cannot be excluded, no granulomas are identified, no dysplasia is seen; 24 Jan 2008, pathology report, hospital, Random Colon Biopsy, microscopic description, biopsies c/o colonic mucosa muscularis mucosa and a small amount of submucosa, the surface epithelium contains a normal number of intraepithelial lymphocytes and shows focal erosion/ulceration, the subepithelial collagen layer appears normal in thickness, the lamina propria contains an increased number of lymphocytes and plasma cells including several foci in which there are aggregates of plasma calls within the basal portion of the mucosa, neutrophilic inflammation is multifocal and involves the surface epithelium and crypts with occasional crypt abscesses, the crypts also demonstrate focal branching and regenerative nuclear changes, a few muciphages are noted within the basal portion of the mucosa in some areas, no viral inclusions granulomas acid fast bacilli or fungal structures are identified; the histological features are not specific, the pattern suggests the possibility of chronic inflammatory bowel disease and can be seen in either Crohn's disease or UC. LABS:  Head CT scan WNL except for incidental finding of megacisterna magna.  Stool (+) clostridium difficile.  Sigmoidoscopy c/w pseudomembranous colitis.  CT scan of abd revealed thickening of bowel mucosa & mild ascities.  Colonoscopy & repeat abd CT scan prior to d/c was WNL.  US of RUE revealed thrombophlebitis.	MIL	MIL	None at time of immunizations	None	Hx of LBP; NKDA	reaction to childhood vaccines (large limb after DTaP/MMR; fevers, local reactions after most vaccine); burning; pain at previou		1						1	Abdominal pain; Biopsy colon abnormal; Biopsy intestine abnormal; Clostridial infection; Clostridium difficile toxin test positive; Colitis; Computerised tomogram abdomen abnormal; Diarrhoea; Full blood count abnormal; Gastroenteritis; Inflammatory bowel disease; Injection site pain; Nausea	ANTH~EMERGENT BIOSOLUTIONS~FAV110~3~SC~UN~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500488P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB431AA~2~IM~UN~HEP B (ENGERIX-B)~1|HEPA~UNKNOWN MANUFACTURER~AHAVB109EA~2~IM~UN~HEP A (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4020076~1~ID~UN~SMALLPOX (DRYVAX)~1	USA	Hospitalisation	Influenza
0305505	02/22/2008	MA	13.0	13		M	02/15/2008	Paralysis of R leg secondary to demyelination lesion in L frontal lobes.  ADEM vs. early multiple sclerosis.  5/7/2008 MR received for DOS 1/08-12/2008 with Final DX: ADEM vs MS.   Pt presented to ER with R lower extremity weakness.  5 days prior to admission pt c/o h/a and sore throat which resolved. Two days later pt had several episodes of falling,the R calf felt heavy, and pt began dragging the R foot while walking.  PE (+) for decreased reflexes of the R ankle and bilateral patellar.  Decresed strength on R. Tx with prednisone taper. 3/31/2008 F/U Neurosurgery visit of 1/18/2008 received.  Pt doing well in f/u for stereotactic biopsy of a parietal mass which was noted to be a demyelinating disease on bx. Pt still has some weakness of the R lower extremities (toes and with dorsiflexion) and with tandem heel-toe walking.  otherwise exam WNL. 02/06/2010 Still some weakness in right leg.			Y		Y	5	Y		U	11/15/2007	01/04/2008	50	craniotomy with removal of lesion for pathology. Labs and Diagnostics: ESR 31. Head CT showed a lesion in the L centrum semiovale with surrounding edema. MRI brain showed a ring enhancing lesion of the L frontal lobe. Brain bx (+) for demyelinating lesion. CSF with 3 WBCs, (+) RBC, CSF protein 23 and glucose 51. (-) oligoclonal bands.  CSF cx no growth.  Lyme (-). Echo with normal ventricular function. Visual-evoked potentials normal.	PVT	PUB	loratadine	None	Hx of RAD; Allergies but not recently. PMH: Obesity. Allergy to cats and mold.			1						1	Craniotomy; Demyelination; Diplegia; Leukoencephalomyelitis; Multiple sclerosis; Nervous system disorder	FLU3~SANOFI PASTEUR~U2524AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2484AA~1~IM~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Life Threatening,Hospitalisation	Influenza
0305506	02/22/2008	DC	27.0	27		M	02/22/2008	On 11 Dec 07, pt noted onset of lightheadedness and feeling of being mildly 'off-balance' while walking.  No flu-like or viral-type symptoms.  No pain.  Over the next few days, pt developed blurry vision most pronounced with reading and far-->near vision.  He numerous discrete episodes of vertigo.  Symptoms progressed to 'wobbly' walking where he could not walk independently.  At that time, he also noted decreased appetite, softening of his voice, slowing of speech, diplopia and incoordination with involuntary movements.  Admitted to medical center for 1 1/2 weeks with some symptom improvement after IV steroids, PT, OT and speech therapy.  Transferred to medical center on 1 Jan and given presumptive diagnosis of brainstem encephalitis.  (Discharged on 24 Jan after continued improvement of symptoms.  (Could walk with 4-point cane, no diplopia up to 100 m, but still images at long distances continued to demonstrate horizontal diplopia.  Having facial contractions.)  Re-admitted to medical center on 2/15/08 for IVIG x5 days after noted MRI changes (presumed ADEM).  Discharged on 2/19/08 with follow up in OT, PT, speech therapy and Neurology.  04/01/08 Reviewed Clinical summary of 2/22/08 & medical records. Admitted 12/20/2007-1/24/08.  Readmitted 2/15-2/19/08.  FINAL DX: cerebellitis; acute disseminated encephalomyelitis Records reveal patient had received vax in past w/o problems.  Patient experienced lightheadedness, feeling off balance, unable to walk, blurry vision, diplopia, vertigo, dysarthria, ataxia, involuntary movements, weakness, decreased appetite beginning approx 28days s/p vax.  Initially seen in clinic & dx w/viral illness.  Continued to worsen & was admitted overseas & transferred to US.  Tx w/IV steroids, PT/OT/ST.  Neuro consult done.  LP done.  D/C to home, wheelchair bound.  Outpt MRI revealed ADEM changes & was readmitted.  On second admission, tx w/IVIG. Vision & balance improved dramatically.  Using only cane since 2/29/08.  To continue outpatient PT/OT & neuro clinic f/u. Annual Follow-up Information 27-FEB-2009: Continue OT and vocational therapy. 2/09 Neuropathy testing - Generally normal. Did not meet criteria for cognitive disorder. 9/08 MRI (results enclosed). Has had L ankle surgery to correct gait. Was diagnosed with mild sleep apnea. Medical disability board pending (submitted in Dec 2008). Follow-up Information 02-MAY-2008: Continues PT and OT. See Neuro note dated 4/16/08.					Y	53			N	11/19/2007	12/11/2007	22	Diagnostic Tests: 8 Feb 08 MRI brain: diffuse cerebellar and cerebral leukoencephalopathy with no evidence of mass, lesion or infarction. 2/19/08 EMG of right orbicularis oris - Nonspecific myokymic discharges.  LABS: CSF: WBC 422 (H), RBC 11,800 (H), polys 8 (H), lymphs 91 (H), glucose 50, protein 570 (H), c/s neg.  MRI brain 12/07 WNL.  Repeat MRI of 2/08 revealed diffuse cerebellar & cerebral leukoencephalopathy c/w inflammatory process.  EMG of right orbicularis oris revealed nonspecific myokymic discharges.	MIL	MIL	None	None	Scoliosis; allergy: amoxicillin	No~ ()~~0.00~Patient		1						1	Ankle operation; Balance disorder; Coordination abnormal; Decreased appetite; Diplopia; Dizziness; Dyskinesia; Dysphonia; Electromyogram abnormal; Encephalitis; Gait disturbance; Leukoencephalomyelitis; Muscle contractions involuntary; Nuclear magnetic resonance imaging brain abnormal; Occupational therapy; Physiotherapy; Sleep apnoea syndrome; Speech disorder; Speech rehabilitation; Vertigo; Vision blurred	FLUN3~MEDIMMUNE VACCINES, INC.~500497P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0305521	02/22/2008	KS	27.0	27		F		Dizziness, nausea, palpation.  Client was seen in emergency room and by family physician.  Prescribe Benadryl.				Y					Y	11/20/2007	11/20/2007	0	Possible reaction to the rabies vaccine.	PUB	PVT		None			KS2007017	1						1	Dizziness; Nausea; Palpitations; Vaccination complication	FLU3~SANOFI PASTEUR~U2514A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|RAB~NOVARTIS VACCINES AND DIAGNOSTICS~U12011A~UNK~IM~LA~RABIES (RABAVERT)~1	USA	Emergency room visit	Influenza
0305526	02/22/2008	MN	67.0	67		F	02/22/2008	Redness, swelling of (L) upper arm, pain in upper arm into shoulder.  Slightly raised, reddened area (hive-like appearance).  Itching.  Given  Benadryl IM.				Y					Y	01/25/2008	01/26/2008	1		PVT	OTH	Synthroid 150 mcg daily	None	Allergic to penicillin; unknown other med. conditions			1						1	Erythema; Oedema peripheral; Pain in extremity; Pruritus; Rash	FLU3~SANOFI PASTEUR~U2494AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1225U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0305100	02/25/2008	KS	37.0	37		F	10/29/2007	Fever, excessive erythema/swelling/pain at injection site.									Y	10/25/2007	10/25/2007	0		PUB	PVT	Betaseron; Desogen	None	MS		KS200716	1						2	Convulsion; Injected limb mobility decreased; Injection site erythema; Injection site pain; Injection site swelling; Pain in extremity; Pyrexia; Thrombotic thrombocytopenic purpura; Injection site erythema; Injection site pain; Injection site swelling; Pyrexia	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U2489AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0697U~1~UN~LA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0305557	02/25/2008	CA	58.0	58		F	02/21/2008	This case was reported by a consumer on 11 February 2008. Seriousness criteria: Other-Medically Significant A 58-year-old female, with no medical history, received an intramuscular left deltoid injection of Fluzone (lot number U2515AA) on 31 October 2007. Immediately following vaccination, she complained of intense musculoskeletal pain in the entire left arm. The pain continued, and the patient became unable to life her arm above her head. She denied numbness, and was able to freely use her fingers. She was seen by a physician, and an x-ray of the arm was within normal limits. Treatment included exercises only; no medications had been prescribed. At the time of the report, the event remained ongoing. The reporter of this case also reported that another patient had complained of arm pain after vaccination with Fluzone; that non-serious event is captured in case number 2008-00442.				Y					N	10/31/2007	10/31/2007	0	x-ray left arm: within normal limits	OTH	UNK			No known allergies, no relevant medical history.		200800441	1						1	Injected limb mobility decreased; Musculoskeletal pain; Pain in extremity; X-ray normal	FLU3~SANOFI PASTEUR~U2515A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0305583	02/25/2008	NY	68.0	68		F	02/25/2008	As described by patient:  Muscle pain from top of legs to calves. Trouble walking, proceeded to difficulty moving legs.  Tests were done to r/o blood clots, arthritis.  MD and PT considering GBS.  Currently walking with a cane.  States symptoms began about 4 days after receiving flu shot. 3/6/08-records received-12/12/07-seen for cardiology consult with C/O chest discomfort in midsternal area occurs with activity and releived with rest. Shortness of breath with activity.12/17/07-C/O knees hurting and arm goes to sleep, Heartburn. Seen on 12/19/07-C/O left knee pain. Fell onto her knees after cataract surgery 3 weeks ago. Knee pain increased after flu vaccine. Pain and swelling of knee with difficulty bearing weight. Impression:blunt trauma left knee.									U	12/04/2007	12/08/2007	4	unsure 3/6/08-records received- EKG first degree AV block.	UNK	UNK	unknown	denied	unknown 3/6/08-records received-PMH: chest pain syndrome, anxiety, history of anemia, mild asthma, sleep apnea, compliant with CPAP.			1						1	Gait disturbance; Mobility decreased; Myalgia; Walking aid user	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80686~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0305585	02/25/2008	CA	46.0	46		F	02/25/2008	Contracted the flu after vaccination.  Felt onset 3 days later, and severe symptoms by 5 days after vaccination. Lasted 1 week. Fever, aches, pain, loss of strength, coughing, runny nose, etc.									Y	02/07/2008	02/11/2008	4	None	UNK	UNK	None	No	None	None~ ()~~0.00~Patient|None~ ()~~0.00~Sibling		1						1	Asthenia; Cough; Influenza; Pain; Pyrexia; Rhinorrhoea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0305590	02/25/2008	OH	72.0	72		F	02/25/2008	Patient is complaining of a sore arm from shot on 10/17/07.  She saw her Dr. and he told her he thought possibly she was injected into a tendon.  She does not remember where she received shot.  MD felt arm & said he felt a lump on her tendon.									N	10/17/2007	02/25/2008	131		OTH	OTH		None				1						1	Mass; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA319BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0305075	02/26/2008	TX	18.0	18		M	02/12/2008	A serious report of blindness, optic neuritis, and headache has been received from a physician concerning an 18-year-old male. The patient had a medical history of tube placement in ears, but was otherwise very healthy. Concomitant medications included Hepatitis A Vaccine and Menactra, which were given on the same day that FluMist was given. The patient received FluMist on 07-Jan-2008. On 11-Jan-2008, four days after receiving FluMist, the patient began to complain of a very bad headache. By 15-Jan-2008, eight days after receiving FluMist, the patient started to complain that his vision was very foggy, so he was taken to see an ophthalmologist. On 15 Jan-2008, an MRI showed no tumor and no Multiple Sclerosis. The patient continued to complain of a severe headache and his vision getting more foggy in the left eye progressing to the right eye. On 07-Feb-2008, one month after receiving FluMist, the patient complained of the inability to see the walls or the computer. He was then evaluated by a neurological ophthalmologist. Several tests were done (unspecified) and the results showed that all of his vision was very bad. On 07-Feb-2008, a spinal tap showed nothing unusual. Cortisone therapy was begun on 07-Feb-2008. The next day, the patient reported that he could not see anything at all. The events were ongoing. The patient did not experience a rechallenge while receiving the suspect product. The reporter provided no causality assessment for the events. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.										01/07/2008	01/11/2008	4	MRI 01/15/08 No tumor; Not MS; Spinal Tap 02/07/08 Nothing unusual	PVT	OTH	Concomitant Drug(s) Not Reported		Past Disease: Ear tube insertion		MEDI0006546	1						3	Blindness; Headache; Optic neuritis; Blindness; Headache; Ophthalmological examination abnormal; Optic neuritis; Blindness; Headache; Lumbar puncture; Nuclear magnetic resonance imaging normal; Optic neuritis; Vision blurred	FLUN3~MEDIMMUNE VACCINES, INC.~500497P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~MERCK & CO. INC.~U259B~UNK~UN~UN~HEP A (VAQTA)~1|MNQ~SANOFI PASTEUR~U2391B~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~2|HEPA~MERCK & CO. INC.~~2~IM~UN~HEP A (VAQTA)~2|MNQ~SANOFI PASTEUR~~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|FLUN3~MEDIMMUNE VACCINES, INC.~500497P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~3|MNQ~SANOFI PASTEUR~~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~3	USA		Influenza
0305698	02/26/2008	CA	15.0	15		M	02/20/2008	A few minutes after vaccine (Influenza), patient's LOC became altered - he was cold and clammy.  I injected him with Epi-Pen Jr.  V/S B/P 83/47, HR 59, RR 16, T 97.4.				Y					N	02/17/2008	02/17/2008	0		OTH	OTH	None	None	None			1						1	Cold sweat; Depressed level of consciousness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81111~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0305710	02/26/2008	MA	78.0	78		F	02/20/2008	Due to fall, head, legs, knees, back, face, nose, eye, ear, arms, hands injured. Emergency 11/17/07. Also 12/12/07.				Y					N	11/15/2007	11/17/2007	2	MRI's, X-rays 11/17/08 to present.	PUB	OTH		None	Codeine, Cipro, Flagyl			1						1	Back injury; Ear injury; Eye injury; Face injury; Fall; Head injury; Limb injury; Nuclear magnetic resonance imaging; X-ray	FLU3~SANOFI PASTEUR~U2513AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0305712	02/26/2008	WI	1.0	1	.0	F		12 mo girl had 1 year old vaccines mth, no signs of illness.  Vaccines given in morning.  Developed fever in evening up to 104 F, had febrile seizure increased 1 minute in length.  Seen in ER.  Doing well the next day.  Signs of first tooth coming through.				Y					Y	02/12/2008	02/12/2008	0	Normal CBC, RSV and influenza negative.  Urine culture and blood culture negative.  CXR normal.	PVT	OTH	None	None	None			1						1	Blood culture negative; Chest X-ray normal; Culture urine negative; Febrile convulsion; Full blood count; Influenza serology negative; Pyrexia; Teething; Virus serology test	FLU3~SANOFI PASTEUR~U245EA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1326F~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C35173~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1577U~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0305713	02/26/2008	WA	1.93	1	.9	M	02/15/2008	Swelling at injection site. No warmth at site.				Y					U	02/14/2008	02/14/2008	0	None	PVT	PUB			None (per mother NKA)	Not to my knowledge~ ()~~0.00~Patient		1						1	Injection site swelling	DTAP~SANOFI PASTEUR~C2798AA~5~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2474F~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0305714	02/26/2008	GA	1.2	1	.2	M	02/14/2008	Pt diagnosed with Varicella (chicken pox) on 2-14-08									U	01/15/2008	02/14/2008	30		PVT	PUB		None				1						1	Varicella	FLU3~SANOFI PASTEUR~UT2475AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB217BA~1~IM~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0427U~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1178U~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0305721	02/26/2008	NY	9.0	9		M	02/19/2008	Approx. 5 min. after rerc. vaccines, patient developed hives on both arms and chest. Given 3 tsp Benadryl by mouth in office and hives resolved.									Y	02/18/2008	02/18/2008	0		PVT	PVT		None				1						1	Urticaria	FLU3~SANOFI PASTEUR~U2524AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1513U~2~UN~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0305723	02/26/2008	TN	17.0	17		M	02/06/2008	Pt came in for vaccination 2/5/08. Ask all screening questions. Pt had no symptoms of flu. Pt was exposed to flu. Mom called pediatrician office and faxed in rx's for influenza vaccine. Mom took child to different office 2/6/08 and determined child had flu. Got Rx filled for Tamiflu. Explained to mother may be side effect not flu. Explained to mother flu vaccine would be de-activated. Pt had temperature, body aches.									Y	02/05/2008	02/06/2008	1		OTH	OTH		no illness at time of vaccination				1						1	Body temperature increased; Influenza; Pain	FLU3~SANOFI PASTEUR~U2507AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0305724	02/26/2008	MI	50.0	50		F	02/17/2008	The nurse administered the shot too high on my left arm. I had immediate pain that did not lessen, but grew worse, affecting my whole joint. I was not able to lift my arm without pain. Dec. 28, 07 I went to an orthopedic dr. who gave me an oral Medrol dose pack. On Jan. 10, 08 the same dr. injected Depo Medrol with 25% Marcaine.				Y					Y	11/29/2007	11/29/2007	0		OTH	PVT	None	None	None			1						1	Arthralgia; Hypokinesia; Joint range of motion decreased; Pain	FLU3~SANOFI PASTEUR~~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0305739	02/26/2008	UT	38.0	38		F	02/26/2008	Respiratory Reaction evident a few hours after the flu shot was administered.  I received a shot around noon and by the early afternoon I was experiencing wheezing symptoms and difficulty breathing.  This lasted through the evening, but did not require hospitalization, nor was treatment sought.  By the morning I was back to normal.  However, I have had repeated wheezing episodes ever since, which have progressively grown worse.  I have sought advice from my primary doctor and a specialist who now inform me I have asthma with no prior symptoms or episodes prior to the flu vaccine.									U	10/24/2007	10/24/2007	0	Breathing tests indicate asthma	UNK	UNK	Was not currently any Rx medications	None	Mild seasonal allergies to molds, mildews and pollens.  Atrial Septal Defect repaired with a clamshell device.  Stroke due to ASD.			1						1	Asthma; Dyspnoea; Pulmonary function test abnormal; Wheezing	FLUX~UNKNOWN MANUFACTURER~LL2504AA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0305746	02/26/2008	IL	70.0	70		F	02/26/2008	Within couple of hours of administration, client experienced chills lasting about halfway through the night. She felt okay when she awakened but in the afternoon, she once again had chills lasting about 2-3 hours. 4 days after the administration of injection, she noted hives on her right arm from shoulder to elbow which lasted a few hours. Occasionally arm still itches.									Y	10/11/2007	10/11/2007	0	None	UNK	UNK	Advair 1x daily; Theophylline 200mg 2x daily; Calcium 600mg 2x daily	None	None			1						1	Chills; Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79896~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0991U~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0305748	02/26/2008	CA	16.0	16		F	02/26/2008	Observed minimal site swelling and moderate heat at injection site of HPV#1.  Patient c/o pain at injection site.  Mom stated only one dose of Tylenol given after injections given for pain but none since that time.									U	02/22/2008	02/23/2008	1	none needed	UNK	UNK	None	General fever stated 4 days prior to vaccinations but no fever for minimum 4 days prior to being vaccinated.  No lethargy, no complaints of generalized pain at time of vaccinations.	None	none~ ()~~0.00~Patient|none~ ()~~0.00~Sibling|none~ ()~~0.00~Sibling		1						1	Injection site pain; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~U2498AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB301AA~4~IM~LA~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHBVB211AA~1~IM~RA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~0930U~1~IM~RA~HPV (GARDASIL)~1|MMR~MERCK & CO. INC.~0986F~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|MNQ~SANOFI PASTEUR~U2221AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2689AA~1~IM~RA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1252U~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0305750	02/26/2008	AZ	23.0	23		F	02/26/2008	Rcvd Flu, live, intranasal on 19 Feb 08. Approx 2 hrs later had slight fever and itchy throat. On the 20th Fever spiked to 103.6, coughing, sore throat, dizziness, weakness, nausea, chills, severe headache. This continued until the 24th of Feb.				Y					Y	02/19/2008	02/19/2008	0	normal	MIL	MIL	none	none	none			1						1	Asthenia; Chills; Cough; Dizziness; Headache; Nausea; Pharyngolaryngeal pain; Pyrexia; Throat irritation	FLUN3~MEDIMMUNE VACCINES, INC.~500534P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0305758	02/26/2008	CA	0.5	0	.5	M	02/26/2008	Intussusception, with obstruction. Required surgery at hospital 1/24/08. 3/7/08-records received for DOS 1/24-1/25/08-DC DX: Intussusception. C/O one day history of vomitng and cramping abdominal pain and listlessness.  Surgery:laparoscopic reduction of intussusception and saline enema.					Y	2			Y	11/19/2007	01/28/2008	70	3/7/08records received-KUB:dilated loop of bowel. Computerized tomography showed intussusception. Unable to reduce with hydrostatic enema.	PVT	PUB	None	None				1						1	Intussusception; Obstruction	DTAP~SANOFI PASTEUR~C2606AA~3~~LL~DTAP (DAPTACEL)~1|FLUX~UNKNOWN MANUFACTURER~LUT2474EA~1~~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PNC~PFIZER\WYETH~B08702H~4~~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1127U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0305762	02/26/2008	WA	51.0	51		M	02/25/2008	Admitted to ER 3 days after vaccination of influenza and pneumoccal (PPV 23) on 2/7/08 for swollen arm.  Diagnosed with left arm cellulitis.				Y					Y	02/07/2008	02/08/2008	1	Chest x-ray, Luevenous Duplex, and  CT of LUE	PVT	OTH	Atenolol	Had a cough 1 week ago				1						1	Cellulitis; Chest X-ray; Computerised tomogram; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79718~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0962U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0305770	02/26/2008	NE	1.8	1	.8	F	02/26/2008	Child developed a fever 102.2 degrees F & seizure.  Mother took child to ER.				Y					Y	02/22/2008	02/22/2008	0	Chest X-ray; urinalysis with culture - all normal	PVT	OTH	None	Had been diagnosed with flu B 2 weeks prior to visit	None			1						1	Chest X-ray normal; Convulsion; Culture urine negative; Pyrexia; Urine analysis normal	DTAP~SANOFI PASTEUR~C2800AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2514AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0800U~2~IM~LL~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0305775	02/26/2008	PA	7.0	7		F	02/21/2008	Had pneumonia 2 wks prior. Had Pneumovax on 2/18/08. That evening developed fever, arm was hard and swollen. This continued and came to ER on 2/20-temp reported 102.				Y					Y	02/18/2008	02/18/2008	0	2/20/08 Essentially negative chest	PVT	OTH	Singulair 10 mg daily; Pulmicort 2 puffs daily	pneumonia 2wks prior	asthma, allergy- PCN, iodine (shellfish)			1						1	Body temperature increased; Chest X-ray normal; Induration; Oedema peripheral; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79241~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0601F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0267166	02/27/2008					F	02/28/2008	We received from a physician the following information on 13 FEB 2008: In 2006 a rabies vaccine (manufacturer unknown was given to a female veterinarian technician, who was in her mid 20's (see case no. MA2008-0186). She decided to get vaccinated in the context of a rabies preexposure trial, due to cost reasons. Between the first and second dose of the rabies vaccine the subject received an additional flu shot (manufacturer unknown). After the vaccination the subject felt heavy on one side of her body, she was hospitalised and passed away one week after the second (?) vaccination. An autopsy has been performed. Addendum: We received on 17 FEB 2008 the information from the physician, that the woman was vaccinated with Imovax and not with RabAvert. No change in assessment.	Y				Y	0			N					OTH	OTH	No other medications	Unknown			MA20080187	1						4	Autopsy; Death; Sensation of heaviness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~4|RAB~SANOFI PASTEUR~~UNK~UN~UN~RABIES (IMOVAX)~4	USA	Results in Death	Influenza
0305847	02/27/2008	ID	1.7	1	.7	M	01/24/2008	12 mo male received flu shot yesterday returns today with rash on knees, elbows, torso and face maculopapular with erythema - no hives. Does not appear viral most likely reaction to  to immunization				Y					U	12/19/2007	12/20/2007	1		PVT	PUB		viral URI				1						1	Erythema; Rash maculo-papular	FLU3~SANOFI PASTEUR~U2458BA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0305849	02/27/2008	ID	46.0	46		F		Patient presented with shortness of breath, chest pressure, dizzy.  Patient states that it was from TB and Influenza vaccines that she received 2 days ago.  No fever was present, no redness/swelling at injection sites.  No oral mucusol edema.  Lungs clear.				Y					Y	02/11/2008	02/14/2008	3	EKG was performed and was normal.	OTH	UNK		None	None		ID08004	1						1	Chest discomfort; Dizziness; Dyspnoea; Electrocardiogram normal	FLU3~SANOFI PASTEUR~U2494AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0305856	02/27/2008	VA	14.0	14		M	02/27/2008	02-21-08 received Varicella and flu vaccine in left arm.  Patient noted swelling and skin warm within 24 hours.  No other symptoms.  2-25-08 saw doctor to follow up on swelling.									Y	02/21/2008	02/22/2008	1	None	MIL	MIL	Albuterol (Proventil); Montelukast 10mm PO	Osgood Schlatter Disease (Knee pain)	Asthma; Allergic Rhinitis; Obesity.			1						1	Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~AFLUA316BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2384BA~1~~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~1507F~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0305864	02/27/2008		0.5	0	.5	F	02/27/2008	Pt seen 20 Feb 08 for persistent keloid-type lesions on both (R) and (L) anterior thighs. These lesions, one on each anterior thigh, measure approx. 5mm x 10mm, and appeared within a week of vaccination. ** This report relates to the injections given 21 Dec 07, which led to the lesion on the (L) thigh. ** A seperate report details injections given 31 Oct 07, related to the lesion in the (R) thigh.									U	12/21/2007	12/24/2007	3	Pt was referred to a civilian Dermatologist on 20 Feb 08 for further evaluation and treatment. Pt has been referred for genetic testing related to diagnosis of coloboma to r/o associated genetic syndromes. ** Prevnar was the only vaccine common to both lesion appearances, R/O aluminum-related macrophagic myofasciitis **	MIL	MIL	NONE	NONE	ECZEMA; RETINAL COLOBOMA (parents declined genetic testing to R/O associated syndromes)	LESION (R) THIGH~Pneumo (Prevnar)~2~0.30~Patient		1						1	Injection site scar; Keloid scar	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B125CB~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2459NA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B47300C~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1128U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0305875	02/27/2008	IN	24.0	24		F	02/27/2008	Patient had surgery on L diaphragm on 1-22-2008.  Vaccines were administered on discharge on 1-29-08. On 1-31-08, patient developed fever and impaired respirations.  She was taken to the local ER where she was diagnosed with large L pleural effusion.  She was admitted to the ICU and chest tube placed.  Removed after 6 days, then had to be replaced due to reaccumulation.  Second tube removed on 2-12-08 and patient released.  On 2-21-08, again developed fever.  Taken to ER where was dx'ed with atelectasis/pneumona.  Treated with enteral antibiotics.  3/11/08 Reviewed hospital medical record for 1/31-2/12/2008 admission which reveal patient experienced fever, respiratory distress approx 2 wks s/p left diaphragmatic hernia repair.   FINAL DX: left pleural effusion & possible left lower lobe pneumonia.  Hypokalemia, respiratory alkalosis & hyponatremia, all resolved. Admitted to ICU.  Chest tube placed left lung & drained 500 ml bloody fluid.  Tx w/IV antibiotics.  Transfused for anemia.  Clinically improved & chest tube d/c. Fever & fluid collection recurred & 2nd chest tube placed.  Eventually chest tube d/c & improved.  D/C to home  6/2/08 Reviewed hospital medical records for 1/22-1/29/2008. FINAL DX: s/p repair paraesophageal hernia Records reveal patient d/c to home with G-tube feedings & J-P drain in place.  Pneumo & flu vaccinations done 1/29/08 but no lot #s included.  Received lot #s verbally from parent. 01/20/2010 Continues to have persistent/recurrent. Left lower lobe atelectasis and recurrent pneumonias.  Left diaphragm does not function properly. This is partially dure to the patch repair of the diapragmatic hernia. Right after surgery, however, muscular portion functioned properly. After the effusion and associated lenes, muscular portion moves paradoxically.			Y	Y	Y	14			U	01/29/2008	01/31/2008	2	Multiple xrays and CT scans  LABS: CBC w/lymphs 15.9 (L), H/H 10.6/31.4  Alk phos 408 (H).  CXR revealed LLL pneumonia.  CT scan revealed large left pleural effusion. Effusion & blood c/s neg.  Urine c/s (+) enterococcal UTI.	UNK	UNK	Routine meds are Depakene, Clemastine, Nexium, Zantac, Sulfatrim, Kondremul, MOM	Post op from repair of para-esophageal hernia with eventration of small and large bowel into chest cavity	Primary microcephaly with resultant cerebral palsy.  Multiple orthopaedic problems, mental retardation.  Has GEReflux and s/p Nissen Gtube (initial and redo x4).  Mild functional immune deficiency.  PMH: Recent repair of left diaphragmatic hernia w/resulting paralyzed diaphragm.  Cerebral palsy, feeding tube.  Seizure disorder.  Congenital hip dislocation w/multiple surgeries.  Wheelchair bound.  Allergies: ceclor & tape.			1						1	Atelectasis; Chest tube insertion; Intensive care; Pleural effusion; Pneumonia; Pyrexia; Respiration abnormal; X-ray	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA303AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~14160~UNK~IM~RL~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0305883	02/27/2008	CA	2.0	2	.0	F	02/27/2008	Fever 2 days after vaccine with diffuse arthralgias. 3/7/08-records received for DOS 2/24-2/26/08-Seen in ED with tonic-clonic seizure, fever to 102.4 the night before. Eyes deviated left and upwards, right hand twitching, right arm and right leg. Unresponsive. In ED right side flaccid and left side still twitching.  3/24/08-DC Summary received-DOS 2/24-2/2708-DC DX: Complex febrile seizure.					Y	3			Y	02/22/2008	02/24/2008	2	NL CPK, NL Renal function 3/7/08-records received-MRI and CT scan no acute intracranial processes. Inflammatory changes in maxillary sinueses and ethmoid air cells and scallopin of right lateral parietal calvarium with no masses. Parietal skull defect consistent with his birth trauma. Blood culture and CSF cultures. Potassium 5.9, c-reative protein 3.7.	PVT	OTH	None	Bilateral otitis media 3/7/08-records received-One week prior to immunization had pink eye.	NKDA, No Illness 3/7/08-records received-Skull and left arm fracture at birth. asthma			1						1	Arthralgia; Blood creatine phosphokinase normal; Pyrexia; Renal function test normal	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0305884	02/27/2008	MI	41.0	41		M	02/27/2008	Client reports itching in hands, feet, elbows and other joints, intermittent, reports very intense.  9-10 scale of 1-10 with 1 being tolerable, 10 being intense.  States began on 2/26/08.  Only took 2 typhoid capsules, stopped when complaints began.  Also reports itching and redness of ears.  Denies swelling or fever.  Instructed to contact physician.									U	02/19/2008	02/26/2008	7		PUB	PVT		None	None			1						1	Generalised erythema; Pruritus generalised	FLU3~SANOFI PASTEUR~U2523AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB448AA~1~IM~RA~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB173AA~1~IM~LA~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1670U~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TDAP~SANOFI PASTEUR~C2844AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0305885	02/27/2008	AR	2.0	2	.0	F	02/27/2008	ER visit 2-22-08.  Complained of redden, firm area, left thigh onset 2-22-08 AM.  No fever.  Area left thigh 3x8cm per ER doctor.  Treatment: warm compresses septra susp.				Y					Y	02/20/2008	02/22/2008	2	None	PVT	PUB	None	None	None			1						1	Erythema; Induration	FLU3~SANOFI PASTEUR~U2532AA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB225BC~3~UN~LL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~B54016F~4~UN~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0305888	02/27/2008	MI	9.0	9		F	02/26/2008	Left outer arm red and warm slight induration 2 x 12									U	02/25/2008	02/25/2008	0	None	OTH	PUB		Pediculosis	Penicillin;			1						1	Erythema; Induration; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80823~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB213AA~1~IM~LA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~14930~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0306042	02/28/2008	PA	49.0	49		M	02/21/2008	Left deltoid pain and in approximately 2 days pain to elbow approximately 2 days pain down to wrist.  On approximately 1/15/08 developed discomfort in antecubital space.  He still has discomfort in left deltoid and left antecubital space lasting approximately 2 minutes at a time several times per day.									N	12/31/2007	12/31/2007	0	None	PVT	PVT	Metformin; Lisinopril 10mg qd; Synthroid 125mg qd.	None	Hypertension; Hyperlipidemia; Graves' disease.			1						1	Myalgia; Pain in extremity	FLU3~SANOFI PASTEUR~U2469AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0989U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0306055	02/28/2008	AR	50.0	50		M	02/28/2008	Patient received vaccination 2/11/08 Left deltoid.  2/13/08 pt began to experience pain left shoulder.  Patient has had no trauma or injury to shoulder area recent or history.  2/19/08 pain became severe radiating into chest and left arm. Patient was taken to the ER. EKG showed no changes, normal chest xray, Cardiac enzymes x 1 normal and shoulder xray showed no abnormalities.  Patient discharged with Medrol dose pack, hydocodone 5/500, and cyclobenzaprine 10 mg. Pain began in left calf 2/23. Shoulder pain more severe, pain at rest and movement, and awakens from sleep. 2/25/08 left calf swelling, calf cool to touch, pedal pulses strong, foot warm and pink.  No muscular weakness noted in legs or arms. Saw APN at health care system 2/25.  Negative Duplex doppler left leg.  Solumedrol IM given, increased dosage on hydrocodone and refill for cyclobenzaprine, discharged home with no diagnosis, referral to orthopedics placed.  2/27/08  calf pain milder, shoulder pain more severe with no relief.  Back to facility in LR. Xray left shoulder and lab drawn (unsure of lab? RA, Sed rate possible, but no CBC or Lytes?) chest xray reported normal. APN did no physical assessment except pedal pulse check (no auscultation of lung fields, no recent Upper Respiratory Infection, no cough,) Discharged with diagnosis of Pleurisy, added Naproxsyn PO QID with referral to Vascular Surgery for pain in calf. Multiple requests made to assess for flu vaccination report, only comments those are very rare. (My assessment at home revealed-Lung sounds with no friction rub, no diminished sounds, clear in all fields on expiration and inspiration, no cough. Pedal pulses 2+ dorsalis pedis and posterior tibia bilateral, foot warm and pink. ) Shrug test negative for rotator cuff tear with normal abduction.				Y					N	02/11/2008	02/13/2008	2	2/19 EKG - no changes, CPK normal, should xray normal. 2/25 Duplex doppler left calf normal. 2/27 chest xray normal, labs ? sed rate, RA ? normal no report provided to patient.	MIL	MIL	Methocarbamol 750mg PO QID for PARS FX L5-S1. Metroprolol Tartrate 25 mg PO BID for HTN.Tramadol 50mg Q 4 hours PRN back pain.	HTN, Pars FX L5 S1 degenerative disorder of spine	same	none~ ()~~0.00~Patient|none~ ()~~0.00~Sibling|none~ ()~~0.00~Sibling		1						1	Blood creatine phosphokinase normal; Cardiac enzymes normal; Chest X-ray normal; Chest pain; Electrocardiogram; Insomnia; Laboratory test; Musculoskeletal pain; Oedema peripheral; Pain in extremity; Physical examination normal; Pleurisy; Ultrasound Doppler normal; X-ray limb normal	FLUX~UNKNOWN MANUFACTURER~~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0306063	02/28/2008	TX	14.0	14		F	02/28/2008	CHILD FAINTED AND HIT HER TOOTH AND MOUTH AND GOT A LACERATION ON LOWER LIP.				Y					Y	02/18/2008	02/18/2008	0	LACERATION REPAIR: DENTAL VISIT	UNK	UNK						1						1	Laceration; Lip repair; Mouth injury; Syncope; Tooth injury	FLUX~UNKNOWN MANUFACTURER~50049~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~09289~UNK~IM~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U25499A~UNK~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0306071	02/28/2008	MI	5.0			M		Hep A Vaccine #1, Varicella #2, and Influenza vaccine administered at 9:20AM. Presented to the clinic at 1:20PM after 20 onset of generalized hives with itching. No dyspnea. Hives resolved with 12.5 MG Diphenhydramine IM. Went home with Rx for 6.25 MG PO Q 6HRS for 24 hours then Q6HRS PRN. Anticipate f/up phone call tonight and in AM.									N				NONE	UNK	UNK		NONE	NONE			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2469AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB171AA~UNK~UN~UN~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1364U~UNK~UN~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0306072	02/28/2008	WA				F	02/27/2008	Large red area in deltoid (entire deltoid) within 24 hours.  Benadryl anti inflammatory.									Y	02/26/2008	02/26/2008	0	None	OTH	PUB		None	None			1						1	Erythema	DTAP~SANOFI PASTEUR~C2798AA~7+~UN~LA~DTAP (DAPTACEL)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80956~2~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0306073	02/28/2008	TN	22.0	22		F	10/24/2007	2 days after receiving flu shot, hot, red, swollen, tender, no fever or chill, loss of use of arm.  Full range of motion of shoulder.				Y					Y	10/22/2007	10/24/2007	2	None	PVT	PVT		None	Allergy to penicillin.			1						1	Erythema; Oedema peripheral; Skin warm; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80686~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0306074	02/28/2008	CA	1.2	1	.2	M	02/25/2008	redness, ecchymosis to surrounding areas 2-3cm diameter small palp nodule <5mm. -appear tid. On Antibiotics.									Y	02/21/2008	02/23/2008	2	None	PVT	PUB	None	None	None Known			1						1	Ecchymosis; Erythema; Nodule	DTAP~SANOFI PASTEUR~C2798AA~UNK~UN~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~80956~UNK~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF295AA~UNK~UN~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C42993~UNK~UN~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0306211	02/29/2008	KY	4.0	4		F	02/29/2008	Mother stated small raised area about 4 cm with small bump around area on the Rt thigh.									Y	02/22/2008	02/24/2008	2	None	PVT	PVT	None	No	Allergies to Omnicef			1						1	Mass	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B051AA~5~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2444AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0170~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0808U~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1338U~2~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0306213	02/29/2008	NY	72.0	72		M	02/19/2008	Pain in left arm (where injection) became painful (throbbing also) immediately (within 24 hours); Since then pain has been severe with throbbing, (intermittently) and loss some range of motion! By 2-19-08 pain has worsened, not lessened. Severe pain left arm only!									N	11/01/2007	11/01/2007	0	No testing	PUB	UNK	None	None	Hay fever, dust allergies, only!	None; Never ever had adverse reaction before this 11-1-07 injection!~ ()~~0.00~In Patient		1						1	Injected limb mobility decreased; Injection site pain; Pain	FLU3~SANOFI PASTEUR~112501AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0306220	02/29/2008	VA	81.0	81		F	03/06/2008	On 10-20-07 Patient complained she had pain, bruise on site of Fluzone injection (on 10/16/07); Looked like she got alot of bleeding under skin. Saw Dr.. HAD PRESCRIPTION: KEFLEX 500MG BOD X7D				Y					N	10/16/2007	10/16/2007	0	cont. on 2/19/08 Patient's back and she said she could not raise her arm and she's on physical therapy	PUB	UNK						1						1	Injected limb mobility decreased; Injection site bruising; Injection site pain	FLU3~SANOFI PASTEUR~U2469AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0306205	03/01/2008	MO	30.0	30		M	03/01/2008	Shot was given too high, into shoulder joint.  Burning when given, pain down to elbow.  General soreness following week.  10 days after severe sharp shooting pain began, weakness, burning.  Treated with anti-inflammatory, MRI showed bone marrow edema and bursitis.  4 months later, shoulder still sore.  This is due to an improper injection, into the joint instead of the muscle.  Shot was given at work through by Occupational Health nurse.  Two others have the same issues.				Y					U	10/29/2007	11/09/2007	11	MRI showed bone marrow edema 3 months afterwards and bursitis, blood work returned normal.  Follow up MRI suggested in 2-3 months	UNK	UNK		none	none			1						1	Blood test normal; Bone marrow oedema; Bursitis; Injection site irritation; Injection site pain; Muscular weakness; Musculoskeletal pain; Nuclear magnetic resonance imaging abnormal; Pain; Wrong technique in drug usage process	FLUX~UNKNOWN MANUFACTURER~~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0306206	03/01/2008	PA	0.75	0	.9	M	03/01/2008	Systemic hives 7 days following vaccination and continued for 2 weeks intermittently. Gastrointestinal pain and diarrhea for 6 weeks. Withdrew socially, stopped responding to name, started zoning out, stopped progressing with language development for 6 months.									N	10/01/2004	10/08/2004	7	RAST test for food allergies at 11 months. Severe egg allergy even though had never eaten an egg or anything containing egg.	PVT	UNK	None	Had fever of 103 day before visit, reason for visit.	Allergic reaction to yogurt week before. Hives.			1						1	Antisocial behaviour; Childhood disintegrative disorder; Diarrhoea; Feeling abnormal; Food allergy; Gastrointestinal pain; Radioallergosorbent test; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0306268	03/03/2008	IL	3.0	3		M	03/03/2008	Patient received an Influenza vaccination (multi-dose) on 1/22/07 during a slightly belated 3 yr physical. Within the weeks that followed the vaccination, patient started shaking his hands like they hurt, wouldn't make sustained eye contact, was talking less, started doing odd rolling eye and large open mouth movements, started twirling his hair/ripping his hair out, and experienced many nighttime sleep issues (not going to sleep or awaking in the early hours.  I called the Pediatrician shortly after onset of odd behaviors (within the first week following the vaccination) and was given a referral to a neurodevelopmental pediatrician.  I returned to the pediatrician on 2/20/07 due to patient having 2 days of over 100 degree fever--which was diagnosed as viral in nature. On 2/21/07 patient was evaluated by the neurodevelopmental pediatrician and diagnosed having behaviors and function consistent with Autistic Spectrum Disorder. I then returned to the regular pediatrician due to patient's excessive and prolonged diarrhea.  Stool samples sent 3/8/07 after 11 straight days of diarrhea (including the specimen) appeared normal per microscopic exam, pH, blood, leukocyte, fat, sugar, reducing substances. Endoscopy was performed on 4/4/07 by a GI specialist: Biopsy of distal colon showed reactive lympoind nodules and eosinophil infiltration of lamina propria. Normal esophagus and duodenum. Diarrhea abated when triggers of IgG mediated food sensitivity are avoided--these food triggers diagnosed in 04/19/07. Patient is continuing to eat a restricted diet, is recieving multiple vitamin/mineral supplements, has been in an autistic classroom at the public school since 1 month after the vaccine event, is receiving additional private speech therapy, and is undergoing chelation to try to remove heavy metals that are consistent with his metabolic blockage profile (as evidenced by his build-up of porphyrin precursors consistent with heavy metal toxicity). His sleep has improved and some of the speech that he lost is returning since his absolute low point last March (2 months after the vaccination) but he is still autistic as quartely follow-ups with the neurodevelopmental pediatrician confirm.  3/11/08 Reviewed pcp medical records of 11/2003 to 12/2007 which reveal expressive speech delay first noted 12/2005. Referred for ST eval 5/2006, for early childhood intervention program 9/2006 & OT 1/2007.  Eval by neurodevelopmental pediatrician 2/2007 who observed poor eye contact, selective attention, difficulty following directions, tantrums, repetitive & perseverative play & stimming.   Referred to allergist & GI.  GI w/u revealed mild allergic type colitis.  Allergy testing reportedly demonstrated elevated IgG to many different food groups.  Tx includes: dietary restrictions & chelation. FINAL DX: Autism Spectrum Disorder. Annual Follow-up Information 19-MAR-2009: Stools have failed to normalized (become formed) for any length of time whatsoever, with runny stools, we still can't potty train. Eye contact is back but engagement is inconsistent and requires strong motivators. The language that patient lost in the 1 month period of downward spiral and onset of gastrointestinal problems following the age 3yr 2mo flu shot is coming back slowly. It is more echolalic than spontaneous and not to the ability or extent of scripting. His abilities have climbed back to where he was at age 3 prior to flu shot, but the GI distress and odd stimming behaviors that he aquired following the flu shot have not gone away.			Y	Y					N	01/22/2007	01/26/2007	4	I have the reports of the stool tests, endoscopy report, evaluations of my son prior to the vaccination by the county and school district, evaluation of my son after the vaccination by the neurodevelopmental pediatrician, the IEP that occurred to place patient in the structured learning (autistic) classroom, his food allergy (IgG) results, various lab tests including chelation pre/post metals and urinary porphyrins.  I have a PCR report that excludes Fragile X.  No other genetic testing was performed per the neurodevelopmental pediatrician's assessment that no other test was warranted.  LABS: fragile X WNL.  RAST neg.  stool analysis WNL.  stool c/s neg.	UNK	UNK	None	None	No physician diagnosed allergies, conditions, or defects. Physician was made aware during the 1/22/07 3yr check up that upon turning age 3 in Nov 06, patient entered the public early childhood program (regular classroom) for his speech delay and sensory issues as assessed by county/district SL, OT, and PT therapists who evaluated him in 10/06 for his eligibility and placement.  Birth hx: 37 wk 5# twin preemie c-section due to placenta abruptio w/blood in stool & mouth.  Parent meds included darvocet & paxil. PMH: impetigo diaper rash, marginal weight gain, RSV, fever, recurrent OM, sinusitis, viral URI, viral diarrhea, minor facial laceration w/sutures, chronic loose bowels	high fever for 3 days~Measles + Mumps + Rubella (MMR II)~1~1.10~Patient|high fever for 3 days~Measles + Mumps + Rubella (MMR II)		1						1	Abnormal behaviour; Aphasia; Autism spectrum disorder; Biopsy intestine abnormal; Blood heavy metal increased; Chelation therapy; Diarrhoea; Endoscopy; Laboratory test; Movement disorder; Polymerase chain reaction; Pyrexia; Sleep disorder; Social avoidant behaviour; Urine analysis; Viral infection	FLU3~SANOFI PASTEUR~U2253AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0306270	03/03/2008	TX	7.0	7		F	03/03/2008	School nurse called 2 days after shots given to report father taking child to doctor due to covered with hives.  Hives first noticed the day after the vaccines were given.  Unable to contact father by phone due to incorrect number on our records.				Y						02/27/2008	02/28/2008	1		UNK	UNK			Father denied allergies at time of vaccine admin, but school nurse says father told her child is allergic to peanuts.			1						1	Urticaria	DTAP~SANOFI PASTEUR~U2354BA~3~IM~RA~DTAP (TRIPEDIA)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80959~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~MERCK & CO. INC.~0614R~4~IM~LA~HEP B (RECOMBIVAX HB)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB171AA~2~IM~LL~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~Z1069~3~IM~LA~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0306271	03/03/2008	MO	30.0	30		F	03/03/2008	Fever and redness at injection site, severe arm pain.				Y					N	02/29/2008	02/29/2008	0		UNK	UNK	MULTIVITAMIN, FISH OIL, METFORMIN	NONE	DIABETES			1						1	Injection site erythema; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~02466AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0990U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0306282	03/03/2008	NH	0.9	0	.9	F	02/19/2008	History of seizure like activity age 4 days - negative EEG (hosp).  11/8/07 vaccines given (Pediarix) manufacturer GlaxoSmithKline, lot # AC21B128AB, route/site: IM R ant-lat thigh.  1/11/08 admit seizures (24 hrs) - refer neuro.  1/23/08 vaccines given (DT pediarix), manufacturer GlaxoSmithKline, lot # AC21B128AB, route/site: IM R ant-lat thigh.  At development screening 1/23/08 noted mild right-sided fine motor difference.  1/25/08 seizures (T 101.2).  1/27 hospital after 4 seizures which lasted 2 days.  3/11/08 Reviewed hospital medical records for 1/11-1/12/2008  FINAL DX: none provided Records reveal patient experienced recurring seizure activity 2 mos prior, 3 wks prior to admission & seizures x 4 the day of admission accompanied that day w/fever.   Seizure activity lasting approx 1 min included body spasms, rigidity, diaphoresis, eyes rolling back in head, urinary incontinence, apnea followed by hypotonia & unresponsiveness. Parent noted right sided weakness, dragging left leg & sleep disturbance.  Peds neuro consult done.  No seizure activity while hospitalized.  D/C to home w/peds neuro f/u & antiseizure med if recurs for more than 5 min.				Y	Y	1			Y	01/23/2008	01/25/2008	2	developmental screening 1/23/08 noted mild right sided fine motor difference; Negative EEG  LABS: CBC WNL w/plts 593 (H).  Chemistry WNL.  Tox screen neg.	PVT	PUB	None		Hx seizure like activity age 4 days; Negative EEG Bili 25.4 age 4d  PMH: w/u for seizures in first wk of life, neuro w/u neg.  Parent w/hydrocephalus & benign seizures until 3yo.			1						1	Electroencephalogram normal; Fine motor delay	DT~SANOFI PASTEUR~U2105AA~2~IM~RL~DT ADSORBED (DECAVAC)~1|FLU3~SANOFI PASTEUR~UT2477FA~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1159U~3~IM~RL~HEP B (FOREIGN)~1|HIBV~SANOFI PASTEUR~UF209AA~2~IM~RL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~A0273~2~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~C41335~2~IM~LL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0306286	03/03/2008	WV	6.0	6		M	03/03/2008	For adult use only Influenza Virus Vaccine Fluarix administered									U	02/29/2008				PUB	PUB		None	None			1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA322BA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0306287	03/03/2008	WV	3.0	3		F	03/03/2008	For adult use only Influenza Virus Vaccine administered									U	02/29/2008				PUB	PUB		None	None			1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA322BA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0306297	03/03/2008	FL	46.0	46		F	02/27/2008	Pt with cellulitis overlying injection site, diagnosed about 50 hours after vaccination with influenza and pneumovax.				Y					Y	02/22/2008	02/22/2008	0		MIL	MIL	Cozaar; Albuterol, Epi-pen	No	Multiple food and drug allergies			1						1	Injection site cellulitis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA071AA~4~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0964U~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0306305	03/03/2008	IL	77.0	77		M	02/07/2008	Patient can't lift left arm above shoulder (Partial loss of motion of left arm). As of 2/28 patient's arm is still painful.				Y					N	10/30/2007	10/31/2007	1		OTH	PUB	Clonidine; Atenolol; Glipizide ER	None	None			1						1	Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2493AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0306400	03/04/2008	OH	57.0	57		F	02/27/2008	At follow-up call, patient complained of swelling Lt severe enough she has to go to ER to get ring cut off (Sat. 2/23/08).  Also had hive like blister at/near injection site of YFVAX, itching, irritation all on Lt arm.				Y						02/21/2008	02/25/2008	4	None	PVT	PVT		None	Sulfa; PCN; ASA			1						1	Injection site urticaria; Injection site vesicles; Oedema peripheral; Pruritus; Skin irritation	FLU3~SANOFI PASTEUR~U2462AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2278AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TYP~BERNA BIOTECH, LTD.~3001291~1~PO~MO~TYPHOID LIVE ORAL TY21A (VIVOTIF)~1|YF~SANOFI PASTEUR~UF139AA~1~SC~LA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0306408	03/04/2008	IA	51.0	51		F	02/27/2008	Employee received Fluzone vaccine 0.1 cc intradermally (L) forearm; redness developed at injection site 1-2cm in diameter; tenderness to touch; resolved within 3-5 days; 7mm pink color - no  tenderness on 2-27-08.									Y	02/19/2008	02/19/2008	0	None	PVT	PVT		None	None			1						1	Incorrect dose administered; Incorrect route of drug administration; Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U2502AA~1~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0306411	03/04/2008	SC	1.0	1	.0	M	02/27/2008	Flu vaccine given SQ while Varivax vaccine given IM.  Doctor spoke with the parent, explained situation, told them what to look for (signs and symptoms), and offered to regive vaccines at later date.  Dad declined.									Y	02/25/2008				PVT	UNK	None	None	Neurosensory hearing deficit; both hearing aids.			1						1	Incorrect route of drug administration	FLU3~SANOFI PASTEUR~U2523AA~2~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1310U~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C35169~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1652U~1~IM~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0306418	03/04/2008	MI	1.0	0	1	F	02/27/2008	Mom called 13 hours after vaccination - child woke with fever 103 - given oral Motrin with reduction in fever 75 minutes later - afebrile since then. This was child's 1st flu shot.									Y	02/25/2008	02/26/2008	1	None	PUB	PUB	None	No	None			1						1	Pyrexia	DTAP~SANOFI PASTEUR~U1965CA~3~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT2477DA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0676U~3~IM~RL~HIB (PEDVAXHIB)~1|IPV~SANOFI PASTEUR~A0273~3~SC~RL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~B70143A~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0306473	03/05/2008	OH	44.0			F	02/29/2008	Follow-up was requested on this cluster and information was received for one of the vaccine recipients (unclear if additional patients were involved) on 22 February 2008 from the original reporter who is a health care professional. This case will be the case of reference for that patient who is a 44-year-old female patient, who had no concurrent illnesses, or pre-existing medical history, and who had received an intramuscular dose of FLUZONE 2007-2008 (lot number U2529AA) on 14 November 2007. The time of vaccination was unknown, and the site of administration of the Fluzone vaccine was not reported. That night following vaccination, the patient woke up felt warmness in her face and self medicated with Tylenol. The following morning, the patient's face was swollen and red, and she self medicated with two Benadryl. The symptoms did not resolve and she presented to the emergency room with itching in her arms and a rash on her face. She was treated with Zyrtec and Prednisone. Final diagnosis was not provided. At the time of this report, the patient had recovered. After medical review of this case, the case was upgraded to serious.				Y					Y	11/14/2007	11/14/2007	0	Not reported	PVT	PVT			Illness at the time of vaccination, other medications, and past medical history were not known.  From new information received on 22 February 2008 the patient did not have any illnesses or pre-existing medical history prior to vaccinations on 14 November 2007.  The patient also had no other vaccine administered within four weeks of 14 November 2007.		200800533	1						1	Erythema; Feeling hot; Pruritus; Rash; Swelling face	FLU3~SANOFI PASTEUR~U2529AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0306496	03/05/2008	TX	13.0	13		M	03/05/2008	According to school nurse, dime-sized area of pain, swelling and erythema to the left posterior upper arm beginning 3/3/08.									U	02/20/2008	03/03/2008	12	none	UNK	UNK	unknown	None reported at time of vaccination	None reported at time of vaccination			1						1	Erythema; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2513AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB171AA~1~IM~RA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2430AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B019AA~1~IM~LA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1655U~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0306503	03/05/2008	AK	32.0	32		M	03/05/2008	VACCINES GIVEN ON 2/20/08, THREE DAYS LATER PT. SAID LFT. UNDER ARM SWOLLEN WITH GOLF BALL SIZE LUMPS, THAN IT MOVED TO THE RT. SIDE WITH BURNING UNDER ARM AND SHOULDER. PT. ALSO WITH RASH.									N	02/20/2008	02/23/2008	3		UNK	UNK		SINUSITIS				1						1	Burning sensation; Lymphadenopathy; Rash	FLU3~SANOFI PASTEUR~U2513AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2842AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0306521	03/05/2008	PA	0.6	0	.6	F	03/05/2008	No adverse event #2 Fluzone was given 13 days early									Y	12/06/2007				UNK	UNK						1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~UT2459AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0306522	03/05/2008	PA	2.0	2	.2	F	03/05/2008	None Fluzone 0.5cc was administered- should have been .25cc									Y	12/18/2007				PVT	PUB						1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~U2508AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0306523	03/05/2008	PA	9.0	9		M	03/05/2008	None 2 doses Fluzone administered when only 1 needed due to age.									Y	12/28/2007				PVT	PVT						1						1	Incorrect dose administered; Overdose	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~U2446AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0306527	03/05/2008	PA	3.0	3		F	03/05/2008	No adverse event - .25cc dose was given instead of .5cc.									Y	01/04/2008				PVT	PUB						1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~UT2460BA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0306529	03/05/2008	TN	78.0			F	10/22/2007	Red, warm lesion 8.5 x 7.5cm - 1 cc borders marked with ink - antibiotics if increased in size.														PVT	UNK						1						1	Erythema; Skin lesion; Skin warm	FLU3~SANOFI PASTEUR~U2542AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0306530	03/05/2008	MA				M	03/04/2008	Administered.										03/03/2004				PUB	PUB		N/A				1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA050AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0296231	03/06/2008	CA	25.0	25		M	11/16/2007	A serious report of idiopathic mitral prolapse resulting in death was received from a nurse concerning a 25-year-old male patient.  The patient's medical history included allergic reaction to amoxicillin in 1990, wherein the patient developed hives.  The patient was not taking any concomitant medications.  The patient received FluMist vaccine for influenza immunization on 17-Oct-2007.  On the same day, the patient also received Adacel, a tetanus, diphtheria and pertussis vaccine.  On 01-Nov-2007, the patient was found dead.  Per the patient's parents, the patient was healthy and had no illness before the death.  The night prior to the death, the patient had dinner and later went to bed.  He was last known to be alive on 31-Oct-2007 at 2300 hours when he was getting ready to go to bed.  He was found dead in his bed by his mother the following morning.  Paramedics were called but the patient was pronounced dead at 0945 hours.  A toxicology test was negative.  The autopsy report showed the following: no trauma, enlarged dilated heart with left ventricular hypertrophy and clean coronaries, parachute deformity with hooding of the anterior mitral cusp and lengthening of the chordae tendineae with mild white thickening of the septal endocardium behind the mitral valve, hyperinflated lungs, pneumomediastinum, enlarged liver and spleen, and an enlarged hepatic portal lymph nodes.  A microscopic report from an agency revealed interventricular septum showing mild fibrous thickening of the left ventricular endocardium, lung showed slight alveolar hemorrhage, and hilar lung with hilar nodes, pulmonary arteries, and bronchus with slight alveolar hemorrhage.  The medical examiner determined that the cause of death was idiopathic mitral prolapse and stated that the condition is a common cause of sudden cardiac death in young adults and is often asymptomatic.  The reporter considered both FluMist and Adacel as suspect vaccines and assessed causality for the events possibly related to either FluMist or Adacel vaccine.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  Summary of follow-up information received on 16-Nov-2007 includes: verbal report of the autopsy and toxicology screening from the patient's parents; patient's state of health prior to his death.  Additional information received on 22-Feb-2008 and incorporated into the narrative: results from the autopsy.	Y	11/01/2007							N	10/17/2007	11/01/2007	15	Autopsy report: no trauma; enlarged dilated heart with left ventricular hypertrophy and clean coronaries; parachute deformity with hooding of the anterior mitral cusp and lengthening of the chordae tendineae with mild white thickening of the septal endocardium behind the mitral valve; hyperinflated lungs; pneumomediastinum; enlarged liver and spleen; enlarged hepatic portal lymph nodes; microscopic report from an agency; interventricular septum showing mild fibrous thickening of the left ventricular endocardium; lung showed slight alveolar hemorrhage, and hilar lung with hilar nodes; pulmonary arteries, and bronchus with a slight alveolar hemorrhage; Toxicology screen negative.	PVT	PVT	None		(+) Allergy to amoxicillin; 1990, developed hives.		MEDI0006140	1						2	Autopsy; Endocardial fibroelastosis; Hepatomegaly; Hilar lymphadenopathy; Left ventricular hypertrophy; Lung hyperinflation; Lymphadenopathy; Mitral valve prolapse; Parachute mitral valve; Pneumomediastinum; Pulmonary hilar enlargement; Splenomegaly; Sudden cardiac death; Toxicologic test normal	FLUN3~MEDIMMUNE VACCINES, INC.~500486P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|TDAP~SANOFI PASTEUR~~UNK~UN~UN~TDAP (ADACEL)~2	USA	Results in Death	Influenza
0306564	03/06/2008	CA				F	03/03/2008	SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 22 February 2008 from a health care provider.  A female patient, age not specified, had received a right deltoid injection of Fluzone SV 2007-2008, lot number U2443AA, on 21 February 2008.  The patient had received a left gluteal, intramuscular injection of Tetanus Toxoid Adsorbed Preservative-free, lot number U1715BA, on 05 February 2008.   Fourteen hours following the 21 February 2008 vaccination, the patient experienced facial swelling and urticarial lesions of the right upper thigh and right elbow.  Blotchy patches were also reported.  The patient was evaluated by a physician and treated with intramuscular Benadryl, intramuscular Solu-Cortef, and subcutaneous epinephrine.  All symptoms resolved within 60 minutes.  Diagnostic testing was none.  The patient was discharged with Allegra D and prednisone.  At the time of this report, the patient had recovered.				Y					Y	02/21/2008	02/22/2008	1		PVT	UNK	The patient was on no other medications.	The patient had no illness at the time of vaccination.	The patient had no illness at the time of vaccination and was on no other medications. She had allergies to penicillin, codeine, latex, and minocins. The patient had received a prior dose of influenza vaccine in November of 2006.		200800567	1						1	Rash macular; Skin lesion; Swelling face; Urticaria	FLU3~SANOFI PASTEUR~U2443AA~2~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0306565	03/06/2008	MN	5.0	5		M	03/05/2008	Had influenza vaccine late afternoon 2/15/08. Had some leg pain that night. Woke up the next morning with leg pain and redness at immunization site. Redness progressed - was seen in ER and admitted to hospital for thigh cellulitis. Received IV antibiotics.  9/16/08 Reviewed hospital medical records for 2/17-2/18/2008. FINAL DX: cellulitis Records reveal patient experienced sleeplessness, crying, lethargic, decreased energy, diet refusal, swelling & redness left thigh, Fever & limping.  No reaction to prior immunizations.  Tx w/IV antibiotics & had allergic reaction to Vancomycin.  Improved & d/c to home w/pcp follow up next day.					Y	1			Y	02/15/2008	02/16/2008	1	Blood culture was negative; white blood count 13,500  LABS: X-ray left thigh WNL.  CBC, chemistry, blood c/s all WNL.  MRSA screen neg.	PVT	PVT	None	None known				1						1	Blood culture negative; Injection site erythema; Pain in extremity; White blood cell count increased	FLU3~SANOFI PASTEUR~49281000750~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0306566	03/06/2008	GA	0.6	0	.6	F	02/29/2008	2/29/08 - Mom states last night child had high fever and had seizures and was taken to hospital after receiving immunizations here earlier that afternoon. Child stayed overnight - Mom states ER doctor - states that immunization did cause fever and seizure. 3/01/08 Mom states child was discharged on 2/29/08 and child is much better.  4/1/08 Reviewed hospital ER medical records of 2/29/2008. FINAL DX: febrile seizure Records reveal patient experienced shaking & blank stare for approx 1 hour.  Fever x 1 day s/p vaccines despite antipyretics.  No further seizure activity in ER & d/c to home to f/u w/PCP.				Y					Y	02/28/2008	02/28/2008	0	LABS: CXR WNL.  CBC, UA & chemistry WNL w/sodium 134 & CO2 19.	PUB	PUB		No	None			1						1	Convulsion; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B132CA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT24736A~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B47442E~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0969U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0306580	03/06/2008	TX	39.0	39		F	03/06/2008	Flu shot given on 10/25/07.  On 10/29/07 developed shingles.  Treated with antiviral, made full recovery.  I don't think the flu shot caused the shingles, but may have resulted in a weakened immune system that would allow shingles to develop.				Y					Y	10/25/2007	10/29/2007	4	11/2 - Skin biopsy performed.  Positive for shingles.	PUB	UNK	Zyrtec, Levoxyl 75 mcg	None	MVP, High ANA, allergies, Hashimoto's Disease			1						1	Biopsy skin abnormal; Herpes zoster	FLU3~SANOFI PASTEUR~Y2492AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0306590	03/06/2008	CA	4.0	4		M	02/07/2008	Patient had seizure in the evening after flu vaccine.  Had just taken Benadryl/Maalox/Viscous Udocaine and Tylenol - unknown if seizure due to meds vs. vaccine.				Y					Y	02/01/2008	02/01/2008	0	Head CT - normal, no labs.	PVT	PUB	Benadryl; Maalox; Xylocaine; Tylenol.	Gingivostomatitis	None		CA080002	1						1	Computerised tomogram normal; Convulsion	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79489~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0306591	03/06/2008	CA	1.86	1	.9	M	12/14/2007	Pt given Flu vaccine (R) thigh on 2/13/07. Mother reports that rash began (R) thigh about 1 hr later, spread to other leg, trunk, arms. No itchy, no trouble breathing. Pt has been on Amoxicillin since 12/6/07 for (R) otitis media. No h/o egg allergy.									U	12/13/2007	12/13/2007	0	N/A	PVT	PUB	Amoxicillin	Otitis media; Upper resp tract infection	None		CA070043	1						1	Rash	FLUX~SANOFI PASTEUR~UT3459RA~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0306593	03/06/2008	PA	10.0	10		F	02/28/2008	Patient with 115mm x 88mm area of redness surrounding Varicella vaccine injection site.										02/26/2008	02/27/2008	1		PVT	PUB		None	None			1						1	Injection site erythema; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~20070716~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~1446U~1~IM~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2404AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~ACB213021CB~1~UN~LA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1368U~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0306594	03/06/2008	OH	73.0	73		F	03/06/2008	Pt called 3/6/08 in morning wanting to know information on flu shot she was given. She said that ever since receiving vaccine she has had chronic pain in her arm. Her doctor said she had an inflammatory disease and patient wanted to know if was brought on by flu vaccine.				Y					U	10/24/2007	10/24/2007	0	Dr has given her blood tests confirming inflammatory disease.	OTH	OTH	Nexium 40mg qd; Naproxen 500mg 1 bid	Unknown	Unknown			1						1	Blood test abnormal; Inflammation; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA298AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0306595	03/06/2008	VA	38.0	38		M	03/05/2008	2 days after 1st oral cap Typhoid: lower GI gurgling liquid diarrhea x 2 wks-> took one day off work. Occurs late morning and early afternoon 1130-1600, occasional nausea, after the initial 2 week diarrhea progressed to soft stool with continuous abdominal gurgles.									U	02/05/2008	02/07/2008	2	None	OTH	OTH	Allegra and Benicar	None	Hayfever - takes Allegra and Benicar			1						1	Diarrhoea; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB050AA~UNK~IM~UN~HEP A + HEP B (TWINRIX)~1|TYP~BERNA BIOTECH, LTD.~3001214~UNK~PO~MO~TYPHOID LIVE ORAL TY21A (VIVOTIF)~1	USA		Influenza
0306801	03/06/2008	KY	0.6	0	.6	M	12/11/2007	Initial report received on 07 December 2007 from a nurse.  A seven-month-old infant male, who is a twin, and who was born premature weighing three pounds and eight ounces at birth, and who had no concurrent illnesses, had received on 06 November 2007, a dose of DAPTACEL (lot number C2607AA); a dose of IPOL (lot number A0170); a dose of PREVNAR (manufacturer Wyeth, lot number B08702D); and a dose of ROTATEQ (manufacturer Merck, lot number 1152U).  The routes and sites of administration were not reported.  Twenty eight days later, on 04 December 2007 at 10:00 a.m., the patient received a first, intramuscular, right thigh dose of Fluzone SV 2007-2008 (lot number U2528AA); and a second, intramuscular, left thigh dose of a medication called Synagis (manufacturer Melimmune, lot number 06E628/06H631).  The Synagis was being given against RSV infection since the patient had been born prematurely.  It was not reported when the first dose of Synagis was given.  On the evening of 04 December 2007, following the Fluzone and Synagis injections, the patient developed a red face, like a wind burn.  The red face received within 48 hours (approximately 06 December 2007) without medical intervention.									Y	12/04/2007	12/04/2007	0		PVT	OTH			The patient had no concurrent illnesses, and had a history of being a twin that was born premature with a weight of three pounds and eight ounces at birth.		200704216	1						1	Erythema	FLU3~SANOFI PASTEUR~U2528A~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0306635	03/07/2008	GA	46.0	46		M	03/03/2008	Swollen top and bottom lips, triage, IV & Benadryl for allergy. Took 5 days (antibiotic and Benadryl									Y	02/22/2008	02/26/2008	4	O.K.	MIL	MIL		Type I diabetes	None			1						1	Lip swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0306637	03/07/2008	MI	1.4	1	.4	F	02/27/2008	Within hours of administering flu .25 and Dtap pt had a 105 degree temp. And a seizure. Called 911-ambulance to medical center. Observed - Motrin (Tylenol given) Discharged on same day - 02-26-08.				Y					Y	02/26/2008	02/26/2008	0		PVT	PUB	Albuterol nebulizer, Pulmicort nebulizer	NONE	Medical condition - Asthmatic Bronchitis			1						1	Body temperature increased; Convulsion	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B051AA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2501AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0306638	03/07/2008	WA	52.0	52		F	02/01/2008	Within 1-3 days following vaccination and continuing to date, shoulder joint pain in the arm receiving the shot. Stiffness, limited mobility and pain in left shoulder. There has been improvement but all symptoms, through less intense, continue. Shoulder is improving slowly.									Y	11/07/2007	11/08/2007	1		OTH	PVT	None	None	None			1						1	Arthralgia; Injected limb mobility decreased; Musculoskeletal pain; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U2449AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0306641	03/07/2008	MA	46.0	46		F	02/29/2008	2 days after receiving the vaccines, the patient was seen with a 5x7cm area of redness about 4cm below the site of the vaccines on the upper arm.  This cellulitis disappeared with a course of erythremyacin.									Y	12/11/2007	12/12/2007	1	None	PVT	PVT	Vitamin C; Multivitamin + minerals	None	History of breast cancer; history of tumor right ear (excised).			1						1	Cellulitis; Erythema	FLU3~SANOFI PASTEUR~U2437AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0990U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0306642	03/07/2008	NH	1.3	1	.3	M	03/07/2008	Area of swelling and erythema appeared on right thigh the evening of vaccination.  Area continues to spread.  Seen once already on 3/6, returning 3/8 due to spreading of site.  Site - right lateral thigh.				Y					U	03/05/2008	03/05/2008	0		PVT	UNK		None				1						1	Erythema; Swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~C41335~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2477FA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~0771F~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0306661	03/07/2008	MI	64.0	64		F	03/07/2008	Acute pain to right shoulder and swelling.  Began 2 hours after injection. History of rheumatoid arthritis and bursitis. Demerol and Phenergan given for pain relief. Next day patient reported no relief for 24 hours following.									U	03/03/2008	03/03/2008	0	x-ray	UNK	UNK		none known	rheumatoid arthritis, previous bursitis			1						1	Musculoskeletal pain; Swelling; X-ray	FLU3~SANOFI PASTEUR~U2525AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0047X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0306676	03/07/2008	HI	7.0	7		F	03/07/2008	Transverse myelitis with hemiparesis truncal weakness, MRI changes in spinal cord from C4 to T 11   Onset of transverse myelitis 2/20/2008 Vaccine given 11/19/2007  IVIG, Steroids given for transverse myelitis given during hospitalization at Hospital.  Patient now in Rehab hospital.  3/11/08 Reviewed D/C summary from hospital for 2/23-3/07/2008 admission. FINAL DX: Transverse myelitis. Patient experienced progressive ascending paralysis x 2 days, back pain, balance difficulty w/falls & fever.  On admission, was unable to walk, had to crawl.  Patient transferred from outlying ER to PICU. Neuro consult done.  Tx w/IVIG x 4, IV steroids & pain meds.  Transferred to ped floor, improved  to be able to walk w/walker & d/c to inpatient rehab on tapering steroids.   3/11/08 Received additional hospital  med records which reveal patient also experienced right foot pain & weakness which quickly progressed to paraplegia w/urinary incontinence, areflexia & absence of pain sensation.  Optho exam WNL.			Y		Y	13	Y		U	11/19/2007	02/20/2008	93	MRI changes in spinal cord from C4 to T 11. Elevated protein, pleocytosis in lumbar puncture.  No organisms identified.  LABS: CT of spinal cord WNL.  MRI of brain & spine abnormal w/swelling secondary to central lesion from C4-T11 c/w transverse myelitis.  LP done.  CSF: RBC 44, WBC 128, segs 11, lymphs 72, monos 16, eos 1, glucose 62, protein 82 (H).  Repeat MRI revealed almost complete resolution.  Blood & csf cultures neg.  H/H 10.8/31.5 (L) WBC 13.5, plts 380K, neutros 62% (H), lymphs 28 (L), monos 7 & eos 1.  Sodium 135.  ALT 8.  Sed rate 19 (H).	UNK	UNK		none	asthma PMH: reactive airway disease			1						1	Asthenia; Blood product transfusion; Hemiparesis; Myelitis transverse; Nuclear magnetic resonance imaging abnormal	FLU3~SANOFI PASTEUR~U2490AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0306678	03/07/2008	MA	3.0	3		M	03/07/2008	Fever 1 day, change in mental status, upper respiratory symptoms, paleness, x 1 week.  Followed by decreased attentiveness, distractability, staring off, staring at objects, side glancing, isolation, OCD behaviors, vocal sounds, posturing, seen on video tapes.  3/14/08 Reviewed PCP medical records. FINAL DX: autism Office records of 9/27/2006 reveal patient there for well child visit.  Able to ride tricycle, jump, speak 3 word sentences, tantrums, picky eater.  Next visit 1/19/2007 for URI.  Next visit 8/2007, parent concerned about possible PDD.  Poor eye contact, does not follow directions, tantrums & screaming, hyperactive, poor socialization in preschool.  Scheduled for neuropsychological & developmental pediatrician eval in 9/2007.  Referred for neuro consult 10/2007 after EEG revealed seizure disorder.  4/4/08 Reviewed neuropsychological evaluation of 10/4/07 provided by parent. FINAL DX: Autism & global developmental delay. Records reveal patient w/developmental delays, verbal & nonverbal communication disorder, social interaction disorder, repetitive activities, stereotypical movements, resistance to change, unusual responses to sensory experiences.    4/4/08 Reviewed neurology evaluation of 10/25/2007 provided by parent. FINAL DX: unable to determine Records reveal unable to adequately examine patient due to fear & screaming but neuro felt something was going on.								Y	N	09/27/2006	09/28/2006	1	dx autism 10/07, slow waves on eeg  LABS: EEG done 10/16/2007 abnormal.	UNK	UNK	none	recovering from upper respiratory infection.	dx severe milk protein allergy at 3 months old;  4/4/08 Parent provided medical records from previous PCP from birth to approx 1 yr of age.  Had allergy testing done.  Bloody stools & dx w/milk protein colitis.  Recurrent episodes of URI.  Otherwise healthy & on target w/development.  PMH: c-section for breech presentation, 7 lb 7 oz, apgars 9/9..  Mother required progesterone to maintain pregnancy & had placenta previa.  Both in hospital x 4 days.  Colic.  Irritability.  Rotavirus infection; not hospitalized.   Family Hx: PDD, nonverbal learning disorder & anxiety.  Mother w/thyroid disease & HA			1						1	Distractibility; Disturbance in attention; Dysphonia; Electroencephalogram abnormal; Mental status changes; Obsessive-compulsive disorder; Pallor; Posturing; Pyrexia; Staring; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~U2178AA~3~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0306687	03/08/2008	IN	0.68	0	.7	F	03/08/2008	Fever of 102 that night, high pitched scream, stopped breathing for a minute.  Doctor was very nonchalant.  Told me to give her Motrin to bring down her fever. Never shared with us that she had an adverse reaction.  2 weeks later, she stopped breathing in my arms again when I asked the doctor about this; she said she was holding her breath on purpose.  Any time patient has ever had shots, her personality would change for about a week.  Usually a very docile and delightful baby, she would actually glare at people, bite and slap when she wasn't getting her way.  A week would pass and she'd go back to being herself.									Y	01/28/2004	01/28/2004	0		UNK	UNK	None	She had undiagnosed bronchiolitis.	None that I know of			1						1	Breath holding; Inappropriate schedule of drug administration; Personality change; Pyrexia; Respiratory arrest; Screaming	DTAP~SANOFI PASTEUR~C1612AA~5~IM~RL~DTAP (DAPTACEL)~1|FLUX~UNKNOWN MANUFACTURER~X0316~UNK~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~SANOFI PASTEUR~UE034AA~UNK~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~495888~UNK~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0306716	03/10/2008	TX	17.0			F	03/07/2008	Information has been received from a physician concerning a 17 year old female with no pertinent medical history or drug reactions/allergies who on an unspecified date was vaccinated with Gardasil 0.5 mL IM.  Concomitant therapy on the same day included influenza virus vaccine (unspecified).  Subsequently after receiving the Gardasil vaccine, the patient fainted and convulsed.  The patient was administered smelling salts, was revived and went home.  No additional information was given.  The patient recovered on the same day.  Upon internal review the convulsion was considered to be an other medical event.  Additional information has been requested.				Y					Y				None	OTH	OTH			None		WAES0802USA05870	1						1	Convulsion; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~UNK~IM~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0306736	03/10/2008	MO	75.0	75		M	03/06/2008	Per MD report, patient began experiencing arthritic symptoms in both wrists which started in the weeks after flu shot. MD states that patient now has early rheumatoid arthritis in both wrists. MD to contact physician at another hospital.  Dosage administered by medical center.									U	01/10/2008				UNK	UNK	AMLODIPINE 10 MG, ASA 81MG, ATORVASTATIN 20MG, OMEPRAZOLE 20 MG, SENNA TABLETS					1						1	Arthralgia; Rheumatoid arthritis; Rheumatoid arthritis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA320AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA320AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~2	USA		Influenza
0306745	03/10/2008	AZ	0.6	0	.6	M	02/25/2008	High fever, lethargy, uncontrolled crying for short periods of time. See attached hospital records.  5/9/08 Reviewed hospital medical records of 2/28-3/3/2008. FINAL DX: atypical Kawasaki's disease w/o evidence of cardiac lesions Records reveal patient expereinced febrile illness x 7 days w/URI s/s, pale, rash, conjunctivitis, acute OM, emesis, fall, irritability, poor appetite, red lips, swelling of hands/feet w/peeling skin on feet.  Cardiology consult done.  Tx w/IVIG & ASA.  Improved & d/c to home on continued ASA w/cardio f/u & serial echocardiograms.   3/11/08 Reviewed ER medical records of 2/21/08. FINAL DX: possible viral syndrome; r/o Kawasaki disease; & prolonged fever.  Records reveal patient w/fever day s/p vaccines w/fall that day hitting back of head & becoming sleepy.  Returned to ER on 2/22/08 for continued fever, cough, post tussive emesis & irritability.  Temp in ER was 103.1  Sick sibling in home.  TX w/IV antibiotics & antipyretics.  Dx at that time Fever & URI on continued oral antibiotics. No improvement & admitted  2/23-2/28/2008.  Hospital medical records reveal patient experienced cold s/s of low grade fever, cough, runny nose, respiratory congestion, wheezing, intercostal retractions x 2 days.  Seen by PCP & sent to ER.  Temp in ER was 104.  Tx w/breathing treatments & IV antibiotics.  Developed diffuse urticarial rash & inflammed conjunctiva.  Continued to run fever as high as 106.  Transferred to higher level of care. Linked w/307191 Follow-up: Telephone and registered mail attempts to communicate for follow-up have been unsuccessful.			Y	Y	Y	11			Y	02/20/2008	02/21/2008	1	See Attached  Hospital labs of 2/28-3/3: CRP 273 (H).  Electrolytes WNL. WBC 26,000 (H), plts 718,000 (H).  Echocardiogram WNL.  SGOT 44 (H).  Viral c/s neg.  Blood c/s neg.  Hospital labs 2/22-2/28: Initial CBC revealed.  ALT 2241 (H), AST 146 (H).  Blood, CSF & urine c/s neg.  CSF: wbc 21, 82% lymphs, glucose 74, protein 23.  CRP 16.8.  Influenza neg.  CXR revealed mild bronchiolitis.	PUB	PUB	None	None	Bronchitis 3 weeks prior  PMH: parent w/URI.  Family hx: asthma, diabetes, heart disease.			1						1	Crying; Lethargy; Pyrexia; Blood culture negative; Bronchiolitis; CSF culture negative; Chest X-ray abnormal; Crying; Culture urine negative; Full blood count; Influenza serology negative; Lethargy; Liver function test abnormal; Pyrexia; Urticaria papular; White blood cell count increased	DTAP~SANOFI PASTEUR~C2800AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2459LB~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0076U~3~IM~LL~HIB (PEDVAXHIB)~1|IPV~SANOFI PASTEUR~A0169-2~3~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~C45150~3~IM~RL~PNEUMO (PREVNAR)~1|DTAP~SANOFI PASTEUR~C2800AA~3~IM~LL~DTAP (DAPTACEL)~2|FLU3~SANOFI PASTEUR~UT2459LB~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~MERCK & CO. INC.~0076U~3~IM~LL~HIB (PEDVAXHIB)~2|IPV~SANOFI PASTEUR~A01692~3~SC~LL~POLIO VIRUS, INACT. (IPOL)~2|PNC~PFIZER\WYETH~C45150~3~IM~RL~PNEUMO (PREVNAR)~2	USA	Life Threatening,Hospitalisation	Influenza
0306750	03/10/2008	MI	6.0	6		F	03/10/2008	Food allergy to milk, which led to soy allergy, sorghum flour allergy  MERCURY IN THE VACCINE!									N	11/13/2006	12/01/2006	18	IGe Positive	UNK	UNK	None-now lots of medications	na	none			1						1	Blood immunoglobulin E increased; Food allergy	FLUX~UNKNOWN MANUFACTURER~~1~ID~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0306757	03/10/2008	PA	0.5	0	.5	F	03/10/2008	My daughter showed flu-like symptoms in the week following a flu shot given on 3/3/2008.  Her symptoms include fever, vomiting, diarrhea, abdominal pain and respiratory congestion.									U	03/03/2008	03/04/2008	1		PVT	UNK		None.	None.			1						1	Abdominal pain; Diarrhoea; Influenza like illness; Pyrexia; Respiratory tract congestion; Vomiting	DTAPHEPBIP~UNKNOWN MANUFACTURER~?~3~SC~LL~DTAP + HEPB + IPV (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~?~1~SC~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PNC~PFIZER\WYETH~?~3~SC~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~?~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0306766	03/10/2008	NY	0.5	0	.5	M	03/10/2008	Intussusception-melena, pain, crankiness and current jelly stool s/p Air enema x2 which failed and required surgical reduction. 5/6/08-records received for DOS 3/6-3/8/08-DC DX: Intussusception. Presented with projectile vomiting since 3/5/08-bloody stools followed that same evening. Well until evening prior to 6 month check up when he was crying an abnormal amount and fever 102.8 2 nights after vaccines. Oral intake decreased.Surgical laparotomy with reduction of intussusception.				Y	Y	3			Y	03/04/2008	03/06/2008	2	x-ray consistent w/intussusception. Air enema 5/6/08-records received- Air enema reduction unsusscessful. KUB possible intussusception. Stool guaic positive.	PVT	OTH	None	Irritability	None			1						1	Enema administration; Intussusception; Irritability; Melaena; Pain; Surgery; X-ray abnormal	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~~3~UN~UN~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~~3~UN~UN~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~~UNK~UN~UN~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0306768	03/10/2008	OR	30.0	30		F	03/06/2008	Prior to 3 vaccines, patient had recovered from low AM blood sugar.  After juice and food consumed blood sugar was 225 (patient tested herself) as reported by patient and she requested 3 vaccines.  She rested 30-40 minutes after immunizations given, then complained of fatigue and feeling funny.  Paramedics took her blood pressure and vital signs where were within normal limits and escorted her to public transportation.  She ended up being taken by ambulance to local ER where she left without being seen after waiting 3 hours.  No diagnosis oz f.u.  Noted in ER record.				Y					Y	02/23/2008	02/23/2008	0	None	OTH	PUB	Unknown		Fibromyolgia		OR200802	1						1	Fatigue; Feeling abnormal	FLU3~SANOFI PASTEUR~U2454AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0804U~1~UN~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2734AA~1~UN~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0306772	03/10/2008	FL	65.0	65		F	03/03/2008	After I received the vaccine, I started with a cold and high fever. I went to the doctor he prescribed Erythromycin for 7 days. It did not helped. I got worse. I went back to the doctor and he prescribed Azithromycin, didn't helped either. I kept getting worse, I had o strength and I felt like if I was going to have a heart attack. I was taken to the emergency room by rescue. I was admitted in the hospital for 3 days, I was first diagnose with pneumonia and after that with asthmatic bronchitis. I've been in my house for about a week now taking the following medications, Iphatropium Bromide Inhalation, Xopenex Inhalation, Levquin, Singular, and Methylpred Nisulonof. I've been out of my job now for about 10 days. I'm schedule to go back to work this Friday, March 7, 2007. I don't know if I can make it, because I still feel very weak. Thank you for your help. 4/23/08-records received for DOS 2/24/-3/25/08-presented with 1 month hitory of congestion and subjective fever soon after receiving vaccine.  DX Bronchitis.				Y	Y	3			Y	01/16/2008	02/14/2008	29	Pneumonia and Asthmatic Bronchitis 4/23/08-records received- CT and Chest X-ray unremarkable. Labs:SEG elevated 80. Blood and urine no growth.	PVT	PUB	Prilosec; Librax; Amlodipine	4/23/08-records received-Antibiotic therapy for 10 days. UTI in January.	4/23/08-records received-PMH: HTN, GERD, anemia, pyelonephritis and pneumonia.			1						1	Activities of daily living impaired; Asthenia; Nasopharyngitis; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80684~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1541u~2~IM~UN~PNEUMO (PNEUMOVAX)~1|TD~MASS. PUB HLTH BIOL LAB~TD168~2~IM~UN~TD ADSORBED (TDVAX)~1	USA	Hospitalisation	Influenza
0306775	03/10/2008	CA	4.0	4		F	03/06/2008	Began 3/5 AM and con't to get worse. Now measures 6 1/4 x 4 1/2. Raised, red and hot. Complained of itching and pain. Recommended Benadryl, Motrin, cool compact and increase fluids.				Y					U	03/04/2008	03/05/2008	1	None	PVT	PVT	None	None	None			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Pain; Pruritus	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B018AA~5~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~A0169~4~SC~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~U2475HA~2~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~1227U~2~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0306795	03/10/2008	NM	14.0	14		M	02/18/2008	Left arm edematous, erythematous present; Patient complained of diarrhea, vomiting, headache, neck and back pain. Left arm is tender to move									U	02/15/2008	02/15/2008	0	2/18/08 VGE, Herpangina, Sinusitis	PVT	UNK	none				NM020802	1						1	Back pain; Diarrhoea; Erythema; Gastroenteritis viral; Headache; Herpangina; Neck pain; Oedema peripheral; Sinusitis; Tenderness; Vomiting	FLU3~SANOFI PASTEUR~UT24758A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1053F~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0307232	03/10/2008	IL	15.0	15		M	12/24/2007	Initial report received from a health care professional on 21 December 2007. A 15-year-old male patient with a medical history of autism spectrum disorder and a known tic disorder, had received an injection of Fluzone SV 2007-2008 and an injection of Menactra on 05 December 2007. Both vaccines were administered intramuscularly in the deltoid and the lot numbers were not reported. Approximately 48 hours after receiving the vaccines, the patient developed a new vocal tic. At the time of this report, the vocal tic persisted and the patient had not recovered.									N	12/05/2007	12/07/2007	2		UNK	OTH	ABILLIFY ,CLONIDINE		The patient has a known tic disorder and autism spectrum disorder. His vaccination history includes at least one influenza vaccine. As per the reporter, it is unknown if the patient experienced any adverse reactions following prior vaccination.		200704401	1						1	Tic	FLU3~SANOFI PASTEUR~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~~1~IM~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0306822	03/11/2008		49.0	49		F	03/11/2008	We received on 28 FEB 2008 from a healthcare professional the following information: A 49-year-old female patient, born on 28 APR 1958, was vaccinated for the first time i.m. with 0.5 ml Fluvirin, batch no. 78479, on 31 OCT 2007.  Within 24 hours, the patient experienced pneumonia, kidney failure and gall bladder failure.  The patient was hospitalised on an unknown date and the gall bladder was removed.  The patient did not have any significant medical history and had never received a flu vaccine in the past.  At the time of reporting, the patient had recovered.  Seriousness criterion: hospitalisation.  Causality: insufficient data (as information from the hospital discharge on important details regarding diagnosis and differential diagnosis is missing).					Y	0			Y	10/31/2007	11/01/2007	1		OTH	OTH	No other medications	Unknown			MA20080289	1						1	Gallbladder disorder; Gallbladder operation; Pneumonia; Renal failure	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78479~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0306831	03/11/2008	IL	4.0	4		M	03/11/2008	Patient developed hives, cough post receiving Varicella, Dtap, IPV, MMR and Influenza (Fluzone) vaccines. Symptoms began at home -> transferred by ambulance to Hosp where he received Rx				Y					Y	02/29/2008	02/29/2008	0		PUB	PUB	None	Allergic rhinoconjunctivitis	None			1						1	Cough; Urticaria	DTAP~SANOFI PASTEUR~C2552AA~5~UN~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2511AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z1069~4~UN~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1313U~2~UN~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1469U~2~UN~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0306833	03/11/2008	CO	3.0	3		M	03/05/2008	Petechia and Bruising - idiopathic Thrombocytopenia; 12/13/07 Platelets 5,000; 2/27/08 Platelets 276,000; no medications 3/24/08-records received-Consultation report for 12/14/07-Assessment:ITP platelet count of 4000 with skin bleeding. Bruises for 1 weeks and nose bleeds on and off for past week. Petechia.									Y	10/17/2007	12/13/2007	57	Serial Platelet Counts. 3/24/08-records received- WBC 4.0. Peripheral blood smear shows normochromic normocytic Red cells with normal numbers. Morphology of white cells with many atypical lymphoctyes. Visual acuity exam 28/6/08- 20/30 each eye. Mild hyperopia. Normal exam. platelet count 4000.	PVT	PVT		none	none	none~ ()~~0.00~In Patient		1						1	Contusion; Idiopathic thrombocytopenic purpura; Petechiae; Platelet count decreased	DTAP~SANOFI PASTEUR~C2657AA~5~UN~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2437AA~3~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB182AA~2~UN~LL~HEP A (HAVRIX)~1	USA		Influenza
0306840	03/11/2008	WA	10.0	10		M	02/29/2008	Erythematous patch with mild swelling to left deltoid.  No treatment given.									Y	02/27/2008	02/28/2008	1	None	PVT	OTH	None	URI, Strep throat infection	None			1						1	Rash erythematous; Swelling	FLU3~SANOFI PASTEUR~U2532AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~14974~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0306841	03/11/2008	KS	71.0	71		M	03/05/2008	Left hand swollen and painful in morning following flu shot.  Then right hand next day, continuing and included shoulders and still have symptoms as of 3-5-08.  Been seen by doctor's on 4 occasions.  Diagnosis of R.A. - meds - Prednisone and Methotrexate.  Not able to work.  No previous RA.  Vaccine given in left shoulder or upper arm.				Y					N	11/06/2007	11/07/2007	1	Rheumatoid Arthritis	PVT	UNK						1						1	Activities of daily living impaired; Musculoskeletal pain; Oedema peripheral; Pain in extremity; Rheumatoid arthritis	FLU3~SANOFI PASTEUR~U2516AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0306870	03/11/2008	KY	37.0	37		M	03/11/2008	Pt reported onset of nausea, vomiting, L arm pain with swelling, headache one day following receiving anthrax vaccination. Symptoms lasted until 3/10/08.									Y	03/04/2008	03/05/2008	1	None	MIL	MIL	None	Possible early respiratory sx.	NKA			1						1	Headache; Injection site pain; Injection site swelling; Nausea; Vomiting	ANTH~EMERGENT BIOSOLUTIONS~FAV158~2~SC~LA~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500535P~5~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TYP~SANOFI PASTEUR~A02212~2~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0306884	03/11/2008	VA	51.0	51		F	03/11/2008	Patient reports immediate pain at site of PNEUMOVAX injection, which subsequently worsened within 10 minutes of injection.  Over the next few days, the site became red, hard, and warm and the area of involved tissue increased to a maximum size of about 6 inches around the injection site by 3/8.  About 24 hours after the injection, the patient developed joint pains (knees, elbows, back), chills (no documented fever) and nausea that resolved within 36 hours after the injection.  Patient denies rash otherwise, including lateral hands and feet.  On 3/9, the pain had somewhat improved, but the patient developed numbness and paresthesias in her left fingers and toes, which prompted her to seek medical attention at the NNMC ED.  She was given a prescription for septra and released.  She has been using ibuprofen as needed for the pain.  Patient reports last vaccine was about 20 years ago.  Contacted on 5/11/08 and this a.m. numbness and tingling had resolved.  Redness, warmth and tenderness has decreased to 70% of what was previously noted.  Edema at injection site > 120 mm not beyond elbow decreased ROM and pain.  Erythema extended about 6' surrounding vaccine site.  Tenderness at pneumonia vaccine site (not flu vaccine site).  Paresthesia primarily left pinky and thumb; resolved by 3/11/08.  Joint pain, multiple joints, knees, elbows, back.  Nausea without vomiting.  Chills. FOLLOW UP REPORT: Contacted patient on 4/21/08. She reports vaccine site of her left upper arm has returned to normal. The sensation has returned in her left pinky finger. She denies systemic symptoms.				Y					Y	03/05/2008	03/05/2008	0	Diagnostic tests - none; Labs - ordered but not completed at time of report - CRP immune complexes, UA.	MIL	MIL	Flovent; Albuterol	None	History of asthma; reports allergy to PCN and large local reactions to bees/wasps.			1						1	Arthralgia; C-reactive protein; Chills; Hypoaesthesia; Immediate post-injection reaction; Injected limb mobility decreased; Injection site erythema; Injection site induration; Injection site oedema; Injection site pain; Injection site swelling; Injection site warmth; Nausea; Pain; Paraesthesia; Urine analysis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA049AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0964U~1~SC~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0273306	03/12/2008		1.0			F	03/11/2008	Information has been received from the FDA (VAERS# 273306) concerning a 1 year old female with a history of probable social/language delay who on 26-OCT-2006 was vaccinated with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot# 655140/0832F).  Suspect vaccination administered on that same day included a dose of PedvaxHIB (OMPC) (manufacturer unknown).  Concomitant vaccinations administered on that same day included a dose of PREVENAR, a dose of IPV (unspecified) and a dose of Flu vaccine (unspecified).  On 05-NOV-2006 the patient experienced seizures post ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot# 655140/0832F) with MRI evidence of brain stem ischemia.  Residual spasticity onset fever 10 days after vaccination.  On 15-MAR-2007 records received from the facility for dates of service of hospitalization for 14 days from 14-NOV-2006 to 28-NOV-2006.  Other symptoms the patient experienced included tongue paralysis, somnolence, musculoskeletal stiffness, dysphagia, demyelination and an (unspecified) neurological symptom.  On 15-MAR-2007 showed an abnormal EEG demonstrating what appeared to be encephalopathic picture associated with spike activity from the left posterior head region.  CSF and lab work did not reveal any conclusive findings.  The patient was not recovered at the time of this report.  One or more of the events required hospitalization and were considered to be immediately life-threatening.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the agency and was released to the agency.  No further information is available.			Y	Y	Y	14			N	10/26/2006	11/05/2006	10	magnetic resonance, 11/05/06, brain stem ischemia; electroencephalograpy, 11/05/06, abnormal; electroencephalograpy, 11/06/06, encephalopathic, spike activity left posterior; magnetic resonance, 11/05/06, abnormal; diagnostic laboratory, 11/06/06, CSF no conclusive findings; laboratory test, 11/06/06, no conclusive findings	PVT	OTH			Developmental delay		WAES0802USA05401	1						2	Brain stem ischaemia; CSF test normal; Convulsion; Demyelination; Dysphagia; Electroencephalogram abnormal; Encephalopathy; Laboratory test normal; Musculoskeletal stiffness; Neurological symptom; Nuclear magnetic resonance imaging abnormal; Pyrexia; Somnolence; Tongue paralysis	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HIBV~MERCK & CO. INC.~~UNK~UN~UN~HIB (PEDVAXHIB)~2|IPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~2|MMRV~MERCK & CO. INC.~0832F~UNK~UN~UN~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~2|PNC~PFIZER\WYETH~~UNK~UN~UN~PNEUMO (PREVNAR)~2	USA	Life Threatening,Hospitalisation	Influenza
0306896	03/12/2008					U	03/07/2008	Initial report received from another manufacturer on 27 February 2008. The other manufacturer received the original report from an anonymous patient. An anonymous patient who did not want to provide any demographics, reported that in the 60's, I got a live flu vaccine and got the flue. The date of vaccination, trade name, manufacturer name, lot number, route and site of administration were not provided. No additional information was provided. The other manufacturer stated they will forward any follow-up they receive.				Y					U				Not reported	UNK	UNK			Not reported		200800599	1						1	Influenza	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0306899	03/12/2008	ND	45.0	45		F	03/10/2008	Initial report received on 29 February 2008 from a health care professional. A 45-year-old female patient, with no illness at the time of vaccination, had received a left deltoid injection of Fluzone SV 2007-2008, lot number U2487AA, on 18 October 2007. Within hours post-vaccination, the patient developed diarrhea and numbness and tingling in her arm (specific arm not reported). The next morning, the patient's face was puffy, and her neck appeared as a sunburn. She had blotchy hives on her abdomen, and her lips were puffy and swollen. The patient also experienced redness at the injection site (onset not specified). The patient self treated with oral Benadryl; and, by six p.m. that day, had improved. She subsequently recovered completely.				Y					Y	10/18/2007	10/18/2007	0		UNK	UNK			The patient had an allergy to sulfa. Additional medical history was denied, and the patient was on no other medications. The patient had received a prior dose of influenza vaccine the year before. There was no illness at the time of vaccination.		200800632	1						1	Diarrhoea; Erythema; Hypoaesthesia; Injection site erythema; Lip swelling; Paraesthesia; Rash macular; Swelling face; Urticaria	FLU3~SANOFI PASTEUR~U2487A~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0306935	03/12/2008	MT	71.0	71		F	03/12/2008	Sore shoulder to elbow, seems weaker than should be. Other arm fine. Noted arm soreness at site for 1-2 days post vaccination. States above symptoms have continued. Declines physician evaluation.									N	11/01/2007	11/03/2007	2	None done	UNK	UNK		No	Unknown			1						1	Injection site pain; Muscular weakness; Pain in extremity	FLU3~SANOFI PASTEUR~U2463AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0306987	03/13/2008	AR	31.0	31		F	11/01/2007	Within 24 hrs of receiving Fluzone flu vaccine developed rash (L) upper chest and neck, then (R) maculopapular drug rash in appearance. Employee contacting private physician.  Headache also. (Reported 11-1-07)				Y						10/29/2007	10/30/2007	1		OTH	OTH	Yasmine oral contraceptive	None	None			1						1	Headache; Rash; Rash maculo-papular	FLU3~SANOFI PASTEUR~U2530AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0306988	03/13/2008	GA	73.0	73		F	03/10/2008	Patient stated she became dizzy the night after shot and it lasted x 2 days. She states her arm was red and itchy. She received shot 3-6-08, she called and reported 3-10-08									Y	03/06/2008	03/06/2008	0		PVT	PVT	Prevacid 1 30mg Daily; Asacol 400mg 2 each meal; Premarin 0.625mg 1 Daily; Zoloft 150mg Daily; Valium 5mg as needed; Remeron 4 1/4 tablet  nightly; Hydrochlorothiazide 1/2 of 25mg Daily water pill; Lipitor 20mg 1 Daily; Advair 250mg Twice D		Asthma, HTN, Fibromyalgia with chronic joint aches, Depression			1						1	Dizziness; Erythema; Pruritus	FLU3~SANOFI PASTEUR~U2507AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0306989	03/13/2008	MO	40.0	40		M	02/12/2008	Took on 2/2/08, came down sick morning of 7th sore throat, joint aches, cough, sweating, cold, running nose, headache, acute bronchitis. Urgent care center for chest xrays that where found out the bronchitis.				Y					Y	02/02/2008	02/07/2008	5	Bronchitis	MIL	MIL	None	None	None			1						1	Arthralgia; Bronchitis; Chest X-ray abnormal; Cough; Headache; Hyperhidrosis; Malaise; Nasopharyngitis; Pharyngolaryngeal pain; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500535P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0306990	03/13/2008	NV	4.0	4		M	02/01/2008	Localized reaction only. Resolved				Y					U	01/31/2008	02/01/2008	1		PVT	PVT		None				1						1	Local reaction	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B062AA~5~UN~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2436AA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0298~4~UN~LL~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0307002	03/13/2008	ID	2.0	2	.6	F	02/19/2008	One day post vaccine. Right thigh swollen from hip to knee. Developed a flat red rash. Rash continued to spread. Took to family doctor and was started on OTC Benadryl. Swelling subsided 4 days post vaccination.				Y					Y	02/15/2008	02/16/2008	1	None	PUB	PUB	No	No	Mom stated child may have asthma and other allergies		ID08009	1						1	Erythema; Injection site swelling; Rash	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC143051AA~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2524AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0307003	03/13/2008	ID	1.0	1	.0	M	02/26/2008	11-19-07 - Received MMR, Varicella, Prevnar and Influenza. 48 hours later broke out in blistery rash and facial swelling. Steroid therapy in ER. 2/25/08 - Received Dtap and Hep A 24 hours later broke out in blistery rash.				Y					Y	11/19/2007	11/21/2007	2	Allergy panel drawn and was normal	PVT	UNK		None	None		ID08010	1						1	Allergy test negative; Blister; Rash; Swelling face	FLU3~SANOFI PASTEUR~U2453AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0413U~1~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08702A~4~UN~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1339U~1~UN~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0307007	03/13/2008	TN	50.0	50		F	03/13/2008	Tendonitis of the shoulder.  I took 2 months of oral anti inflammatory meds, and PT.  Next month I was sent to an ortho doctor he gave me a shot and 1 month of pt. The next month same thing.  No MRI was done an xray was done.  Now I am dx with bursitis and they want to do an MRI after 4 months.  I was told by emplyoee nurses that they had 3 other case reported  and that they found it was the vaccine that caused it and not the technique of the RN.  Anyway my shoulder is still not back up to 100% like it was prior to the shot.									N	11/14/2007	11/14/2007	0	xray only	UNK	UNK			High Blood Pressure, Fibromyalagia			1						1	Bursitis; Tendonitis; X-ray	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0307010	03/13/2008	AL	10.0	10		M	03/13/2008	Site of Tdap has knot, red, raised, warm approximately 5.5cmx5cm.  Site of flu vaccine is red, raised and warm with 4.5cmx6.5cm area.				Y					U	03/11/2008	03/12/2008	1		UNK	UNK		Strep	Allergic to bee stings			1						1	Injection site erythema; Injection site mass; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2523AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2730AA~1~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0307015	03/13/2008	TX	35.0	35		M	03/13/2008	Elevated heart rate, palpatations, light headedness, headache, feverish, nausea.				Y					Y	03/11/2008	03/11/2008	0		MIL	MIL	None	None	None	Very similar to above; heart racing, light headedness, nausea, headache~Hep B (no brand name)~3~33.80~Patient		1						1	Dizziness; Headache; Heart rate increased; Nausea; Palpitations; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500534P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TD~UNKNOWN MANUFACTURER~C27163~2~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1|TDAP~UNKNOWN MANUFACTURER~C27163~2~IM~RA~TDAP (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0307031	03/13/2008	NJ	13.0	13		F	03/11/2008	The day after vaccine administered returned to our office with c/o vomiting that started the night after pt was vaccinated (same day). Vomiting continued to the day of presentation. Also with tactile fever and achiness. Recommended Tylenol.				Y					Y	11/06/2007	11/06/2007	0		PVT	PVT		None noted	Hx of allergies and urticarial rash	Sore throat~HPV (Gardasil)~2~0.00~In Patient		1						1	Pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2446AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1063U~3~UN~RA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0307064	03/14/2008	WI	50.0	50		F	03/09/2008	Uncontrollable muscle twitching in entire body, extreme and debilitating weakness, uncoordination, ataxia, numbness, tremors, occasional slurred speech, difficulty performing daily living tasks, mental/mood problems, dizziness, insomnia, loss of appetite.  3/19/08 Reeiewed ER medical records of 2/28/2008. FINAL ER DX: dysarthria & left arm weakness of unclear etiology Records reveal patient experienced left arm weakness & hand/finger contractions since 12/2007 w/intermittent slurring of speech.   3/24/08 Reviewed additional ER records & labs from hospital: ER 1/18/08: muscle twitching & uncoordination left arm & hand, left leg twitching & weakness, right side twitching, tingling fingers & toes, constipation, urinary retention. ER 3/4/08: increased muscle contractions all over  body, decreased appetite.  3/25/08 Reviewed neuro note of 3/10/2008. FINAL DX: anonopathy/motor neuronopathy w/upper extremity predominance. Records reveal patient w/tinnitus, night sweats, dysphagia, palpitations, IBS, urinary urgency, easy bruising, fatigue & faintness.  Exam revealed prominent thoracis kyphoscoliosis, deformed right toes, livedo reticularis, increased skin & joint elasticity, tone increased w/left side spasticity, slow coordination left hand & leg, gait left hemiparesis.  Labs, x-rays & MRIs were reviewed. Additional labs were ordered & she was instructed to apply for disability.  Depending on labs, was to be followed in ALS clinic.   5/23/08 Reviewed additional hospital & neurologist medical records for 1/18/08-4/7/2008. FINAL DX: muscle spasms, left CTS, neuropathy, glossalgia, intermittent dysarthria Records reveal patient seen in ER for muscle twitching, uncoordination & weakness.  Unable to work.  Exam 2/6/08 revealed trophic changes to right side of tongue w/white spots.  Referred to ENT. Follow-up: The family, including patient, feel her physical condition is directly related to the vaccine. The neurologist diagnosed patient with ALS but did not commit to a yes or no if this resulted from the vaccine. Her symptoms began shortly after being vaccinated. She can no longer raised her hands and arms, unable to walk, cannot feed herself, etc. She now is losing her ability to talk. The neurologist now admits that some of her symptoms are not typical of ALS.  I am the mother of patient responding to your inquiry. I am enclosing a copy of patient's journal as her physical problems have progressively gotten worse. She has been seen by two neurologist and after a battery of tests, MRIs of her whole body, EEG, EMG, CAT scans, blood work etc they have ruled out anything else and have come up with the diagnosis of ALS, aka Lou Gehrigs disease. We have pointedly asked the doctors if it could have resulted from her flu vaccine they were uncommitted. She had never had flu shot before as she has had a very active immune system since childhood and could not tolerance many meds. She is an RN and worked and was in an urgent care clinic. At the urging of her manager she conceded to get the progressed at an alarming rate. She has been unable to work since January and is now on Social Security disability. We definitely feel this is the result of the flu shot which was resulted in her immune system going into overdrive. We are not looking for any monetary compensation but would like this reaction to be explored further and see if there is some medical solution that would result in her getting better. She can no longer care for herself and needs 24 hour care. The prognosis is not good. Although most ALS patients are given 2-6 years of life and many live to 20 years after diagnosis patient has deteriorated this much in 4 months. Thanks for your continued interest in this matter. We would be thankful for anything you could offer in medical advice as to a solution or relief in her situation. We being a faith family are praying for a miracle as we don't want to lose our daughter/sister at this young age. Symptoms - Uncontrollable muscle twitching in entire body; location vary; mostly in arms, legs; also in chest, abdomen, buttox. - Uncontrollable finger movements; fingers twitch. - Impaired fine motor skills; difficulty writing, brushing teeth, buttoning, zippering, cannot play piano, etc. - Difficulty raising arms to shower, wash hair; very jerky movements. - Legs weak, uncoordinated; feel loose at the hips. - Tingling in fingers, legs, toes; occasional burning feeling in legs, spine. - Occasional difficulty speaking - speech slurred, heavy; worse when talking a lot. - Occasional feeling of all over tremors, extreme shakiness. - Periods of uncontrollable yawning; inappropriate laughter; - Occasional lightheadedness, dizziness; feeling I may pass out. Above symptoms worse with increased movement, activity. Onset : ~ 12/17/07- L side only - L arm, L leg; twitching only. 1/2/08- Finger twitching - L side. 1/4/08- Loss of L hand and leg coordination. 1/18/08 - R arm twitching. 1/22/08- Loss of R hand, leg coordination. 3/2/08- Symptoms worse; ? seizure-like activity, loss of emotions; no appetite; severe insomnia, muscle convulsions. 3/17/08- All muscles twitches and contracting- neck, back, chest, arms, legs, hands, feet; no sensation in toes, finger tips; no coordination; fingers seize up and curl into a ball; unable to lift light objects; loss of function - cannot shower (unable to lift arms, hold onto objects); cannot pull a zipper, open a button, brush teeth, wash dishes, etc: hands stiff, tight. Legs shaky, uncoordinated; very tipsy; passed out once outside- fell face down into mud; numb toes and fingers, spreads up forearms and calves (numbness). Speech problem ongoing; extreme slurred speech the more I talk or after walking to exercise. Still lack of emotions - unable to cry, laugh, feel anxiety; feel in constant state of frustration; easily frustrated with simple tasks; cannot sit still or relax; severe insomnia; constantly break out in sweats; very hot, then extremely cold on/ off throughout entire day. Gag when eating, brushing teeth. HTLV? Polymyositis? Immunoassay work-up? Flu vaccine? Steroids or immunosuppressives? Staph - Unhealing sores in face. Physical and message therapy. Tongue burning, leukoplakia, swelling. Muscle biopsy; PET scan. Severe hip pain at night; L elbow. Old Teflon, moth balls. Menopause? Other CA? Uterine, bladder, colon? Need Soc. Security benefits; unable to work. Lorazepam addiction. Copy of records, esp. EMG. Increase CK. Tay-Sachs -what is this? Increase ESR.				Y				Y	N	11/07/2007	12/15/2007	38	MRI; EEG; bloodwork - through hospital  LABS: EMG/NCS of LUE & LLE abnormal & c/w CTS.  MRI brain & c-spine WNL except for DDD of c-spine.  LP w/CSF WNL.  EEG WNL   MRI of T-spine revealed acute mild compressions fx T11 & T12; mild spondylosis.  MRI L-spine revealed mild spondylosis.  Repeat MRI head/neck done 2/28 WNL revealed mild to mod c-spine degenerative spondylosis & accompanying foraminal narrowing.  12/28/07: CXR WNL. C-spine revealed DDD & bilateral foraminal stenosis.	OTH	OTH	atenolol; Timoptic XE	None	High blood pressure; glaucoma  PMH: allergic penicillin, demerol, IVP dye, adhesive tape & sulfa.  Uterine fibroids, asthma, migraine headaches.  Intermittent urinary retention & constipation.  Father w/spinal tumor.  Smoker. Hyperlipidemia, arthitis.			1						1	Activities of daily living impaired; Affective disorder; Anorexia; Asthenia; Ataxia; Coordination abnormal; Dizziness; Dysarthria; Glossodynia; Hypoaesthesia; Insomnia; Mental disorder; Muscle swelling; Muscle twitching; Polymyositis; Retching; Tremor	FLU3~SANOFI PASTEUR~U2437AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0307065	03/14/2008	AR	75.0	75		M	01/07/2008	Pt. developed swelling in legs with purple discoloration under skin the day after flu shot given.  Pt. has seen doctor other than Dr., is on oral steroid - tentative diagnosis - allergic purpura.  3/19/08 Reviewed hospital medical records of 12/9-12/13/2007 admission. FINAL DX: Henoch-Scholein purpura, resolving. Records reveal patient experienced swelling & purplish discolortion of legs x several days.  PCP vs of 11/29 dx w/purpura & tx w/steroids.  Cleared lesions but they recurred in addition to discoloration & swelling of scrotum.  Tx w/IV steroids & transfused w/PRBC.  Improved & d/c to home on tapering steroids. .				Y	Y	4			N	10/29/2007	10/30/2007	1	CBC; PT; PTT; CMP  LABS: CT of abdomen WNL.  H/H 8.3/25.  WBC 13.4K.  Plts 226K.  Sodium 131.  UA WNL	PVT	OTH	BP med.	None	High blood pressure; NKDA  PMH: HTN, GERD		AR0810	1						1	Full blood count; Henoch-Schonlein purpura; Laboratory test; Oedema peripheral; Prothrombin time; Skin discolouration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78990~2~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0307073	03/14/2008	AR	45.0	45		F	11/16/2007	Complained of muscle spasms from hand to neck and shoulder blades that started day after vaccine.  Arm swollen, warm to touch for 7 days.  No fever, no chills, still complaining of spasms.				Y					Y	11/05/2007	11/07/2007	2		PUB	OTH	None	None	None		AR0802	1						1	Muscle spasms; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U2514AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0307074	03/14/2008	AR	41.0	41		F	11/02/2007	Patient reports approximately 10pm 11/01 when went to bed developed wheezing, tightness in chest and throat lasting 30 minutes.  Did not seek medical care.  No problems since.									Y	11/01/2007	11/01/2007	0	None	PUB	UNK		None	None		AR0801	1						1	Chest discomfort; Throat tightness; Wheezing	FLU3~SANOFI PASTEUR~U2514AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0307092	03/14/2008	NY	2.0	2	.5	M	12/14/2008	Lt. upper thigh 11 1/2 x 11 cm well defined erythema warm/edematous										03/12/2008	03/13/2008	1		PUB	PUB		well child				1						1	Injection site erythema; Injection site oedema; Injection site warmth	DTAP~SANOFI PASTEUR~C2933AB~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2461CA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB216AA~1~IM~LL~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~A0301~3~IM~RL~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0307127	03/14/2008	OR	2.0	2	.2	F	03/14/2008	Returned to clinic, 3/6/08 with complaint of rash and fever. Hx of spots within 24 hours of vaccination. Spots started resolving 2 days ago. Swollen glands since yesterday and fever last night, 102 degrees. Seen by Dr.--dx tonsillitis, rash, possible epiglottitis, fever, emesis, ?immunization reaction, RAD; referred to ER for evaluation, dx with Acute exudative tonsillitis. Seen in ER 3/8/08, dx viral exanthem.				Y					Y	02/11/2008	02/12/2008	1		UNK	UNK						1						1	Acute tonsillitis; Bronchial hyperreactivity; Inflammation; Lymphadenopathy; Pyrexia; Rash; Skin discolouration; Viral rash; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B128AB~UNK~IM~~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U72459NA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF205AA~UNK~IM~~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0747U~UNK~IM~~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C35171~UNK~IM~~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~13434~UNK~IM~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0307131	03/14/2008	WY	1.69	1	.7	M	03/14/2008	Influenza/Prevnar shot given 3/5/08; prt reported temp of 104.8 and seizures next day- taken to ER. F/u with pediatrician on 3/7/08.				Y					Y	03/05/2008	03/06/2008	1	ER performed RSV/strep swab, CXR, and bloodwork that all returned negative per mom. Pediatrician followed bloodwork which reported negative for cultures.	UNK	UNK	none	none reported by mom	none			1						1	Blood test normal; Body temperature increased; Chest X-ray normal; Convulsion; Culture negative; Streptococcal identification test negative; Virus culture negative	FLU3~SANOFI PASTEUR~UT2477BA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C45893~2~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0307140	03/14/2008	CO	43.0	43		F	03/14/2008	Began with fever, then noted diarrhea, dyspepsia. Symptoms onset after vaccine and persisted today. Seen and labs sent for evaluation.				Y					U	03/06/2008	03/06/2008	0	Pending	UNK	UNK	Vicodin, ibuprofen, Tylenol	breast pain	back pain			1						1	Diarrhoea; Dyspepsia; Laboratory test; Pyrexia	FLU3~SANOFI PASTEUR~U2453AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~MASS. PUB HLTH BIOL LAB~TD167~1~ID~LA~TD ADSORBED (TDVAX)~1	USA	Emergency room visit	Influenza
0307142	03/14/2008	GA	18.0	18		M	03/14/2008	2 hours after immunization broke out in rash each lesion approx size of a quarter. Skin hot to touch but no fever. Seen in ER @ 6PM. Gave Benadryl po, Albuterol 2mg tab & Loratidine.				Y					Y	02/22/2008	02/22/2008	0	none	UNK	UNK		Had cold symptoms @ time of immunization.	none			1						1	Rash; Skin lesion; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA274BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0307144	03/14/2008	MT	83.0	83		F	03/14/2008	Sore Arm since influenza vaccine on 11-1-07. Has been seen by her HCP and was told she has a lump under muscle at injection site. She states that she cannot raise arm above shoulder or take her arm out of coat sleeve. Reports arm was fine prior to flu shot. Did not remark about any other symptoms except arm soreness during next 1-2 days.				Y					N	11/01/2007	11/03/2007	2		UNK	UNK						1						1	Hypokinesia; Injected limb mobility decreased; Injection site mass; Pain in extremity	FLU3~SANOFI PASTEUR~U2463AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0307412	03/14/2008	WI				U	02/28/2008	A non-serious report of influenza was received from a consumer concerning a child of unknown age and gender.  This case is submitted in accordance with a companies post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  No relevant medical or drug history information was reported.  The child was given FluMist in November 2007.  The patient developed influenza infection in February 2008.  No outcome for the event was provided by the reporter.  Rechallenge is not applicable.  The reporter did not provide a statement of causality to FluMist.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U					OTH	OTH	Not reported		None		MEDI0006602	1						1	Influenza	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0307413	03/14/2008	IA	4.0			M		A nonserious report of expired dose of vaccine administered has been received from a physician concerning a four-year-old male patient. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on an unknown date. The FluMist had expired on an unknown date. The reporter indicated that no adverse events have occurred since the time of the report. Rechallenge is not applicable to this adverse event. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y					UNK	UNK	Concomitant Drug(s) Not Reported				MEDI0006564	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0307414	03/14/2008	IA	2.0			F		A nonserious report of expired dose of vaccine administered has been received from a physician concerning a two-and-a-half year old female patient. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on an unknown date. The FluMist had expired on an unknown date. The reporter indicated that no adverse events have occurred since the time of the report. Rechallenge is not applicable to this adverse event. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y					UNK	UNK	Concomitant Drug(s) Not Reported				MEDI0006563	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0307415	03/14/2008	CA	3.0	3		F	02/05/2008	A non-serious report of expired dose of FluMist administered was received from a physician concerning a three-year-old female. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 year to 59 months of age for FluMist. No medical history nor concomitant medications were reported. The patient received FluMist vaccine on 05-Feb-2008. The FluMist vaccine administered had an expiration date of 31-Dec-2007. A follow-up call to the reporter four weeks later on 04-Mar-2008 confirmed that the patient did not experience any adverse events after receiving the expired FluMist vaccine. The patient did not experience a rechallenge while receiving the suspect product. The reporter did not provide a statement of causality. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This is in follow-up to report(s) previously submitted on 02/05/08. A non-serious spontaneous report of expired dose of FLUMIST administered was received from a physician concerning a 40-month-old female. No medical history was reported. There was no adverse event associated with this medication error; therefore, treatment and reported/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received on 21-Nov-2008: No adverse event occurred as a result of the medication error.									Y	02/05/2008	02/05/2008	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0006523	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500490P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0307148	03/16/2008	CA	24.0	24		M	03/16/2008	Patient developed Bell's Palsy - as yet unresponsive to corticosteroid and B12 therapy.								Y	N	11/28/2007	12/04/2007	6		MIL	MIL	None	None	None			1						1	Facial palsy; No therapeutic response; Dysarthria; Eye disorder; Facial palsy; Full blood count normal; Hypoaesthesia facial; Laboratory test normal; Liver function test normal; Red blood cell sedimentation rate normal; Syphilis test negative	FLUN3~MEDIMMUNE VACCINES, INC.~500496P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500496P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|MEN~UNKNOWN MANUFACTURER~UNK~UNK~IM~LA~MENINGOCOCCAL (NO BRAND NAME)~2	USA	Disabling	Influenza
0306745	03/17/2008	AZ	0.6	0	.6	M	03/17/2008	High fever (up to 106 during hospitalization). Hospitalized from 2/23-2/28, lethargy, uncontrolled crying for short periods of time, diffuse papular urticaria rash.  Due to persistent fever infant transferred to tertiary care for further workup. Transfer diagnosis: possible viral syndrome, r/o Kawasaki disease, r/o other causes of prolonged fever. Follow-up: # not in service; all available information is incorrect; mail undeliverable. Telephone and registered mail attempts to communicate for follow-up have been unsuccessful.					Y				U	02/20/2008	02/21/2008	1	CBC WBC 16.8; LFTs slight elevation; blood, CS and urine cultures negative; flu screen negative; chest xray showed mild bronchiolitis	UNK	UNK	none	none			AZ0802	1						2	Crying; Lethargy; Pyrexia; Blood culture negative; Bronchiolitis; CSF culture negative; Chest X-ray abnormal; Crying; Culture urine negative; Full blood count; Influenza serology negative; Lethargy; Liver function test abnormal; Pyrexia; Urticaria papular; White blood cell count increased	DTAP~SANOFI PASTEUR~C2800AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2459LB~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0076U~3~IM~LL~HIB (PEDVAXHIB)~1|IPV~SANOFI PASTEUR~A0169-2~3~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~C45150~3~IM~RL~PNEUMO (PREVNAR)~1|DTAP~SANOFI PASTEUR~C2800AA~3~IM~LL~DTAP (DAPTACEL)~2|FLU3~SANOFI PASTEUR~UT2459LB~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~MERCK & CO. INC.~0076U~3~IM~LL~HIB (PEDVAXHIB)~2|IPV~SANOFI PASTEUR~A01692~3~SC~LL~POLIO VIRUS, INACT. (IPOL)~2|PNC~PFIZER\WYETH~C45150~3~IM~RL~PNEUMO (PREVNAR)~2	USA	Hospitalisation	Influenza
0307177	03/17/2008	FL	0.6	0	.6	F	03/13/2008	Initial report received on 04 March 2008 from the patient's uncle. A 7-month-old female patient, with a past medical history of reflux, had received a first dose of FLUZONE SV 2007-2008 (lot number U2442AA) on 24 September 2007. The route and site of administration of the Fluzone vaccine was not provided. It was unknown if the patient had any illnesses at the time of the vaccination. Approximately two months post-vaccination, the patient experienced seizures. The patient required an emergency room visit with subsequent hospitalization (date not reported). An electroencephalogram (EEG) was performed that revealed seizure activity. The recovery status of the patient was reported as Unknown. No other relevant medically significant information was provided.				Y	Y	0			U	09/24/2007	11/24/2007	61	An electroencephalogram (EEG) was performed that revealed seizure activity.	UNK	UNK		It was Unknown if the patient had any illnesses at the time of the vaccination on 24 September 2007.	The patient had a history of reflux.		200800650	1						1	Convulsion; Electroencephalogram abnormal	FLU3~SANOFI PASTEUR~U2442A~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0307179	03/17/2008	AR	56.0	56		F	04/27/2005	11-23-04 - developed weakness in leg and trouble with her balance; 12-04 - weakness in legs progressed until patient had to use cane to walk; 2-05 - now has to use a walker/cane and c/o severe joint pain; A. Received Flu vaccine 11-18-04; B. On 11-23-04 patient noticed weakness in left leg and had trouble with her balance. C. Weakness continued to increase for several weeks, patient had to start using a cane to assist with walking. D. Jan and Feb saw DR who suggested a diagnosis of neuropathy. E. April of 05 patient now c/o pain down both legs, can only walk with cane or walker and has constant joint pain especially in legs. 7/16/08-records received-Presented on 12/6/04 with C/O neck hurting several years ago. Lots of tension. Dragging left lower extremity, left arm hurts from flu shot. Cervical spine pain. PE: mild scoliosis. Assessment: cervical disc syndrome, lymbar disc syndrome, osteoarthritis left knee, possible torn medial meniscus. Complaints continued.								Y	N	11/18/2004	11/23/2004	5	ROI signed to Private Providers  7/16/08-records received-MRI lumbar spine normal. MRI cervical spine eccentric central and left lateral spurring at C6-7. Borderline spinal canal stenosis.EMG/NCV suggestive of an S1 nerve root compression.	PUB	PUB	see continuation sheet; Colace; Lamatril; Rdiferfa; Advir; Albuterol Inhaler; Combivent; Singular; Antivert; Trazodone 200gm Daily; Effexor 150 mg Daily; Zanax 1 (25 mg) three times a day; Neurontin 100 mg twice a day;	None	Asthma; Colon removed; Bipolar disorder; Arthritis 7/16/08-records received- Problems with left lower extremity throughout life expecially since spinal for daughter's birth. PMH: colon cancer, lung disease, blurred vision, dizziness, irregular heartbeat, gout, depression, shortness of breath, bi-polar disorder, urinary problems, ringing in ears, complications with anesthesia.		AR0814	1						1	Arthralgia; Balance disorder; Muscular weakness; Neuropathy; Pain in extremity; Walking aid user	FLU3~SANOFI PASTEUR~U1531AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0307180	03/17/2008	OR	57.0	57		F	03/11/2008	Received vaccine on Friday Oct 27 - Saturday red rash covered my left arm, swelling and fever, hearing was distorted. Hearing grew worse over next day - called doctor for treatment. Later to specialist - lost my hearing.  3/21/08 Reviewed PCP medical records 10/26/07-3/11/08. FINAL DX: none provided Records review patient experienced swelling or left arm w/rash & oral thrush.  On 10/26 received PCV & flu vaccines.  10/30 dx w/injection reaction & tx w/steroids & antihistamine.  TM/s were normal but having vertigo & hearing problem.  Noted to have retraction right TM.  Tx w/continued steroids & decongestant.  Note of 3/11 does not address hearing or vertigo status.   3/25/08 Received ENT medical records of 11/07-11/30/2007. FINAL DX: right sided sudden sensorineural hearing loss. Records reveal patient noted rash, n/v & right ear hearing loss day after pneumo vax.  No improvement w/tx.  Exam revealed dull right TM w/fluid in right middle ear.  Dx: right serous otitis media & possible mixed hearing loss.  Tx w/antibiotics & steroids.  Returned for audiogram 11/16/07 which was abnormal.  Referred for MRI.  Returned 11/28/07.  No improvement.   Referred for hearing aids.								Y	N	10/26/2007	10/26/2007	0	Audiology  MRI was WNL.	PVT	UNK		None	None PMH: osteoporosis, HRT, depression, pneumonia 1 yr ago, former smoker.			1						1	Acoustic stimulation tests; Deafness; Erythema; Hearing impaired; Oedema peripheral; Pyrexia; Rash	FLU3~SANOFI PASTEUR~80685~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1035F~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0307183	03/17/2008	SC	48.0	48		M	03/17/2008	Generalized not feeling well, flu-like symptoms evening of flu shot that persisted thru week; 10 days after flu shot feels burning-rash-like sensation across abdomen; no visible rash, took Benadryl X 2 doses, also unable to urinate, went to ED Foley catheter placed, 12 days post vaccination still unable to urinate, tingling/numbness in legs, loss of sensation/weakness; ascending paralysis; MD diagnosed Guillain Barre' syndrome; has had nerve conduction studies, the last ones very consistent with Guillain-Barre'; completed 5 days of IV IG.  He has also been on Solu-Medrol, pt has required mechanical ventilation, plasmapheresis, currently remains in ICU with quadraplegia. 4/28/08-records received for DOS 3/4-4/16/08-DC DX: Myeloradiculitis secondary to flu vaccine. Status post tracheostomy. Status post percutaneous gastrotomy. Several weeks following flu vaccine developed urinary retention followed by ascending motor and sensory dysfunction consistent with Landry Guillain Barre syndrome. Ventilator dependent for short period off during day but at night goes back on ventilator for support. Several apneic episodes. Treated with IVIG and plasmapheresis. Prior to third run of plasmapheresis suffered a respiratory arrest due to mucous plugging. Developed pneumonia and became septic. At time of discharge able to sit up with assistance, failed swallowing evaluation. Tube feeding.  1/20/2010 Patient expired several months ago.			Y		Y	42			N	02/15/2008	02/24/2008	9	04/28/2008-records received-MRI head showed some nonspecific white matter changes. Spinal fluid revealed a traumatic tap protein near 200, consequently felt to have Landry Guillain Barre syndrome. Nerve conduction studies on 3 occasions all progressed in demyelinating pattern. Final set showed no responses. Leukocytosis 14,000. Follow-up Information: Anormal CSF. Abnormal MRI head. Abnormal NCS.	UNK	UNK	None	None	None known 4/28/08-records received-PMH: hypertension and borderline diabetes.	None~ ()~~0.00~Patient|None~ ()~~0.00~Sibling|None~ ()~~0.00~Sibling		1						1	Asthenia; Blood product transfusion; Burning sensation; Catheter placement; Dysuria; Hypoaesthesia; Influenza like illness; Malaise; Mechanical ventilation; Nerve conduction studies abnormal; Paraesthesia; Paralysis; Plasmapheresis; Quadriplegia; Sensory loss	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79719~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0307207	03/17/2008	CT	0.6	0	.6	F	03/07/2008	Within 12 hrs of receiving Pediarix, Prevnar, and flu vaccine temp to 103 and papular rash on shoulder, chest, back. Received Motrin.									U	03/06/2008	03/06/2008	0	None	PVT	PUB	None	None	None			1						1	Body temperature increased; Rash; Rash papular	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B133DA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2477FA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C45891~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0307208	03/17/2008	FL	38.0	38		M	03/05/2008	Fever, nausea, diarrhea, body ache									Y	03/04/2008	03/04/2008	0		MIL	UNK			NKA			1						1	Diarrhoea; Nausea; Pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|TD~UNKNOWN MANUFACTURER~~UNK~UN~UN~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0307209	03/17/2008	KY	8.0	8		F	03/10/2008	Given FluMist - has complained of chronic abdominal pain since then - almost on daily basis. Periumbilical. no weight loss. Miralax and Prevacid no help.				Y					N	11/16/2007	11/28/2007	12	CBC, Sed rate, CMP, Stool cx U+P negative; Urine culture negative; Abdominal x-ray negative	PVT	UNK		None	None			1						1	Abdominal X-ray; Abdominal pain; Culture stool negative; Culture urine negative; Full blood count normal; Laboratory test normal; Protein urine absent; Red blood cell sedimentation rate normal; Stool analysis normal	FLUN3~MEDIMMUNE VACCINES, INC.~500492~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0307212	03/17/2008	CA	4.0	4		F	03/12/2008	Vomiting, stomach ache, poor appetite, pain and swelling to left arm.  Released with Tylenol.									N	03/10/2008	03/12/2008	2		PVT	PUB		None	None			1						1	Abdominal pain upper; Decreased appetite; Oedema peripheral; Pain in extremity; Vomiting	DTAP~SANOFI PASTEUR~C2651AA~2~UN~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2476AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~20326~2~UN~LA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0307587	03/17/2008	NY				F	03/14/2008	Information has been received from a physician concerning a female who was vaccinated with her second dose of GARDASIL.  Concomitant therapy included influenza virus vaccine (unspecified).  Subsequently the patient fainted after receiving both vaccines.  The patient sought unspecified medical attention.  Additional information has been requested.									U				Unknown	OTH	OTH			Unknown		WAES0802USA02090	1						1	Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~2~UN~UN~HPV (GARDASIL)~1	USA		Influenza
0307825	03/17/2008	TX	14.0			F	03/14/2008	Information has been received from a consumer concerning her 14 year old daughter with a seasonal allergies and a medical history of an appendicectomy (date not reported), who on 19-OCT-2007 was vaccinated with the first dose of GARDASIL.  Concomitant therapy included cetirizine hydrochloride (ZYRTEC) and an influenza virus vaccine (unspecified).  Subsequently, in October 2007, within two weeks after receiving her first dose of GARDASIL, the patient began to experience headaches that lasted all day.  The patient went to her pediatrician, whose name was unspecified, and told the patient to get more sleep and become more hydrated.  The patient also went to a chiropractor.  After following the pediatrician's recommendations the headaches still persisted and the patient then sought the medical attention of a neurologist.  The neurologist scheduled an MRI, performed a complete physical and diagnosed the patient with NDPH, which stands for New Daily Persistent Headache.  The consumer also reported that the neurologist stated, these headaches could come from a virus.  The consumer contacted the pediatrician to see if the patient had any previous illness, which she had not.  The consumer informed the neurologist that her daughter had the GARDASIL vaccine and a flu shot.  The neurologist was not sure if this could be the cause of the headaches.  The consumer stated that if the headaches keep persisting, she may have to take the patient to the hospital.  At the time of this report the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.				Y					N	10/19/2007			Magnetic resonance unknown; Physical examination unknown.	OTH	OTH	Zyrtec	Seasonal allergy	Appendicectomy		WAES0802USA05985	1						1	Headache; Nuclear magnetic resonance imaging; Physical examination	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~1~UN~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0307932	03/17/2008	NM	13.0	13		M	03/04/2008	This case was reported by a healthcare professional and described the occurrence of injection site soreness in a 13-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline) for prophylaxis. Previous and/or concurrent vaccination included influenza virus vaccine (Novartis) given on 27 December 2007. Concurrent medications included ZOLOFT. On 27 December 2007 at 11:00 the subject received 1st dose of HAVRIX (1 ml, left arm). On 27 December 2007, immediately after vaccination with HAVRIX, the subject experienced injection site soreness. The subject also experienced inappropriate dose of vaccine administration as he received the adult dose. The nurse noted that she thought the soreness at the injection site was from the alcohol not drying completely. At the time of reporting the soreness at the injection site was unresolved.										12/27/2007	12/27/2007	0	UNK	PVT	PVT	ZOLOFT	Unknown	History: No allergies.		A0701029A	1						1	Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80683~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAV113144AD~1~IM~LA~HEP A (HAVRIX)~1	USA		Influenza
0307240	03/18/2008	MO	52.0	52		M	03/11/2008	Optic neuritis 6 wks after vaccine.  Rx high dose solumedrol followed by prednisone. 3/31/08-treatment records received from facility for DX optic neuritis. IV steroid therapy. 5/6/08-records received for DOS 2/15/08-presented with left eye visual symptoms, began somewhat abruptly 10 days prior with visual blurring and left periorbital pain. Moving his eyes caused some discomfort. Optic nerve head pallor and some peripapillary hemorrhages. Treated with Solu-Medrol.				Y					Y	12/05/2007	02/05/2008	62	(-) MRI head and optic nerve; (-) Visual evoked response; Left visual field defect 3/31/08-records received-MRI brain small multiple deep white matter abnormalities symmetric, somewhat peripheral changes of a demyelingating process but this would still be within differential. Normal appearing left optic nerve and remainder of the optic pathway appears uremarkable. 5/6/08-records received-MRI brain showed nonspecific white matter changes. MRI of orbits no abnormal enhancement, 3 or 4 subcoritcal white matter deep lesions. Visual evoked potentials no evidence of abnormal or remarkable delay. No deymyelinating lesion.	PVT	PVT	None	None	None			1						1	Nuclear magnetic resonance imaging normal; Optic neuritis; Visual evoked potentials normal; Visual field defect	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78478~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0307241	03/18/2008	OR	8.0	8		F	03/13/2008	3 days after vaccine in the morning developed a seizure, nasal stuffiness and sore throat. One week later had a cough, then fever. 2 weeks later placed on Augmentin ES for sinusitis and Zithromax for bronchitis. Began wheezing 3 weeks after vaccine. started asthma meds. Diagnosed pneumonia. Added Prednisone. Went on airplane, became hypoxic, needed emergency oxygen. Taken to Emergency room. Fully recovered.  4/1/08 Reviewed ER medical records of 12/29/2007. FINAL DX: Pneumonia. Records reveal patient experienced SOB, & feeling ill since vax date w/multiple respiratory illness.  Dx w/pneumonia on 12/24/07.  Completed the antibiotics as prescribed for that.  Currently on antibiotics for sinusitis, nebs & steroids for respiratory problems w/o improvement.  Exam revealed decreased air movement & slight wheezing.			Y	Y					Y	11/27/2007	11/30/2007	3	CXR infiltrates; EEG; MRI brain normal; CBC normal 12-21-07 (one month after vaccines).  LABS: CXR abnormal w/fullness in each hilum, left greater than right w/chronic interstitial changes.	PVT	PVT	Pulmicort, Singulair, Albuterol only with URIs; Was off meds		Mild intermittent asthma; Seizure disorder; was diagnosed with a selective immune deficiency as infant that was no longer clinically relevant.  PMH: IgG deficiency, selective antibody disorder.			1						1	Bronchitis; Chest X-ray abnormal; Convulsion; Cough; Electroencephalogram normal; Full blood count; Hypoxia; Nasal congestion; Nuclear magnetic resonance imaging brain normal; Oxygen supplementation; Pharyngolaryngeal pain; Pneumonia; Pyrexia; Sinusitis; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500492P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~MERCK & CO. INC.~1258U~2~UN~RA~HEP A (VAQTA)~1	USA	Life Threatening	Influenza
0307268	03/18/2008	CA	82.0	82		F	02/22/2008	Public Health Nurse provided me a written report from a patient that had an adverse reaction after receiving the Influenza vaccine. The PHN's written pt. complaint described the symptoms as (L) upper arm pain with redness and warmth to touch which current extends to (L) breast. Pt. also noticed rash from (L) deltoid area to above the elbow. Denies rash in breast. Pain got progressively worse since 2/19/08 but localized to (L) arm and (L) breast. Pt denies any flu like symptoms. Pt advised to see PMD /emergency room as soon as possible. Pt education given in common side effects lasting 1-2 days. Concern regarding rash; body aches. Pt verbalized understanding				Y					U	02/19/2008	02/19/2008	0		PUB	PUB	Unknown	None	None			1						1	Influenza like illness; Injection site erythema; Injection site pain; Injection site warmth; Pain; Rash	FLU3~SANOFI PASTEUR~U2509AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0307281	03/18/2008	NY	59.0	59		F	03/18/2008	This case was reported by a pharmacist (the subject's brother) and described the occurrence of hardness at the injection site in a 60-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline) for prophylaxis. The subject's medical history included breast surgery. The subject receives unspecified concurrent medications. On 2 November 2007 the subject received 1st dose of Fluarix at 1 ml in an unknown arm. At an unspecified time after vaccination with Fluarix, the subject experienced hardness at the injection site, injection site pain, injection site swelling and injection site discomfort. This was considered to be a local reaction. The pharmacist considered the events were disabling as the subject has had difficulty performing her job. At the time of reporting the events were unresolved. The pharmacist considered the events were probably related to vaccination with Fluarix.								Y	N	11/02/2007			BREAST SURGERY; The subject had breast surgery over ten years ago. The subject has previously received flu shots and the reporter did not think that there were any reactions to previous flu vaccines or other vaccinations.	OTH	OTH	Unknown	Unknown	BREAST SURGERY; The subject had breast surgery over ten years ago. The subject previously received flu shots and the reporter did not think that there were any reactions to previous flu vaccines or other vaccinations.		A0716240A	1						1	Injection site discomfort; Injection site induration; Injection site pain; Injection site swelling; Performance status decreased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3BBA~1~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Disabling	Influenza
0307282	03/18/2008	OR	75.0	75		M	03/18/2008	This case was reported by physician and described the occurrence of swelling of the left side of the neck in a 75-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline) for prophylaxis. The subject's medical history included gout. Concurrent medical conditions included asthma, degeneration joint disease, diabetes, gastrooesophageal reflux disease, hypertension, hypothyroidism and obesity. Concurrent medications included Lovastatin, Allopurinol, Thyroxine sodium (Levoxyl), Metformin hydrochloride (Metformin), Lisinopril, Fluticasone propionate+salmeterol xinafoate (Advir) and Mometasone furoate (Nasonex). On 27 November 2007 the subject received 1st dose of Fluarix in an unknown arm. On 17 December 2007, 3 weeks after vaccination with Fluarix, the subject experienced swelling of the left side of the neck. The subject was referred to an Ear Nose and Throat doctor. A biopsy was performed on an unknown date and the subject was diagnosed with lymphoma on 16 January 2008. The subject was referred to an oncologist. The outcome of neck swelling was not known. The lymphoma was unresolved at the time of reporting. This case was assessed as medically serious by GSK. The physician considered the events were possibly related to vaccination with Fluarix.									U	11/27/2007	12/17/2007	20	A biopsy performed on an unspecified date diagnosed lymphoma.	PVT	PVT	lovastatin; allopurinol; thyroxine sodium; metformin hydrochloride; lisinopril; fluticasone+salmeterol; mometasone furoate	ASTHMA,DEGENERATIVE JOINT DISEASE, DIABETES, GASTROOESOPHAGEAL REFLUX DISEASE, HYPERTENSION, HYPOTHYROIDISM, OBESITY	GOUT; The subject has previously received flu shots with no known reactions. There have been no known reactions following previous vaccinations.		A0716233A	1						1	Biopsy; Local swelling; Lymphoma	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA307BA~1~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0307288	03/18/2008	GA	1.3	1	.3	M	03/18/2008	Rash began on back, then spread to buttocks and chest. Lesions are itchy. To do Benadryl and gave script for Acyclovir by mouth.				Y					U	10/24/2007	03/15/2008	143	None	PVT	PVT	None	None	None			1						1	Pruritus; Rash; Skin lesion	FLU3~SANOFI PASTEUR~U2440AA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0808U~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1269U~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0307297	03/18/2008	KY	24.0	24		M	03/18/2008	Presented to Medical Clinic on 3/17/08 with c/o knot to lower right shin times one week. MD evaluated. 4-5cm lump on medial aspect of right tibia. MD believes associated with smallpox vaccination.				Y					U	03/08/2008	03/10/2008	2	None	MIL	MIL	None	None	PCN			1						1	Mass; Pain in extremity	ANTH~EMERGENT BIOSOLUTIONS~FAV158~1~SC~RA~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500502P~4~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~PFIZER\WYETH~UNK~1~ID~LA~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~A02212~2~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0307358	03/19/2008	MS	12.0	12		M	02/28/2008	Patient was walking on a treadmill as he often does.  Patient grabbed left side of chest and said mama and collapsed.  He was unconscious and constricted.  Incident happened on 2-5-08 about 5:30.  Mother took to ER at 18:03.  Accuv-102 et EEG.				Y					Y	02/05/2008	02/05/2008	0	EEG	PVT	PUB	None	None	None			1						1	Electroencephalogram; Loss of consciousness; Muscle contracture; Syncope	FLUN3~MEDIMMUNE VACCINES, INC.~500500P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0307379	03/19/2008	KY	27.0	27		M	03/19/2008	Presente to the Medical Clinic on 3/18/08 with c/o rash times 2-3 days. MD evaluated and noted maculopapular lesions 20-30 on back and abdomen and carbuncle to the occipital ridge posterior scalp. Diagnosed with dermatitis probably rash due to smallpox reaction per MD and carbuncle. Given Cephalexin and Benadryl. RTC if worse.				Y					U	03/05/2008	03/16/2008	11	None	MIL	MIL	None	None	NKA			1						1	Carbuncle; Dermatitis; Rash maculo-papular	ANTH~EMERGENT BIOSOLUTIONS~FAV158~1~SC~RA~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500502P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~PFIZER\WYETH~UNK~1~ID~LA~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~A02212~3~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0307389	03/19/2008	WI	40.0	40		F	03/19/2008	This is a 40-year-old female who went down to the travel nurse and received several immunizations on Wednesday afternoon, March 12. She had a previous hepatitis A vaccine on 02/12/2008. On 03/12/2008, she had an influenza which looks as though it was put into the IM deltoid of the right arm. She had a polio IPV on 03/12/2008, subcu in the left upper arm, and a typhoid IM in the deltoid on the left. Where she is having her pain and discomfort it was shortly after receiving the immunization, she points to the lower of 2 immunizations that appears to be more along the posterior aspect of the arm and it is about a quarter in size. It is more at the triceps area or the inferior and lateral aspect of the deltoid where the polio was given. There was an immunization given IM and that looks like it would be a little more superior and we suspect that would be the typhoid. Regardless, the patient has broken out in a rash that is maculopapular throughout her entire body, face, on the top of her head.  She first noticed the rash on Thursday am when she woke up. (The vaccines were given Wednesday afternoon.)  She has them in her mouth. She does feel that she has had a slightly thick-sounding tongue. She has had some facial edema and she also feels that her throat is tight.  The facial edema and throat tightness were first noticed on Friday am.  Again, her rash is about her upper abdomen, her chest, her upper back, her arms, her face, her neck, and now into the groin area, a little bit less so on the legs. She did have some dizziness on Thursday and she felt this was maybe secondary to this and did not have any throat symptoms until today. OBJECTIVE: Temperature is 98.4. Blood pressure is 102/68. Weight is 247.6. On exam, she is a pleasant, cooperative lady with a rash about her face with also some swelling, some thick-sounding voice probably secondary to histamine release. On examination, the ears are without erythema. The nose is patent, no drainage. Tongue in the midline. Tongue does appear to be somewhat thick. She does have spots on the inside of her mouth at the oropharynx that are similar to those on her skin. No exudates at the throat. No sore throat is otherwise noted. The neck is supple, anterior adenopathy 1+. The lungs are clear throughout all lung fields. No wheezing, rales, or rhonchi noted. She is not having difficulty swallowing. Rash is maculopapular. It is pretty much peppered throughout the face, neck, and upper extremities. Examination of the injection site reveals an erythematous area that appears to be more like a hive. I can see the outline of the Band-Aid. I can also see the outline of the gauze central area of the Band-Aid as well. It is warm to touch. The other injection site appears to be more in the upper portion of the arm closer to the humeral head and I do not see any irritation there. The right arm does not reveal any irritation or reaction to the injection. Abdomen is soft, nontender without hepatosplenomegaly.   Plan:  We will get her started on some Benadryl at night and I did give her some samples of Claritin and Xyzal, which is the new antihistamine on a once a day basis that she could try if she prefers. Cool showers, symptomatic care. Aveeno anti-itch lotion would be recommended. We did not feel that a cortisone injection was appropriate at this time, although she may need further evaluation if she is not showing adequate clearing.				Y					Y	03/12/2008	03/13/2008	1	none	UNK	UNK	Patient was on day 6 of a clindamycin prescription at the time of immunization on 3-12-08.  Her regular medications include:ALBUTEROL 90 MCG/ACT INHALER  ASPIRIN 325 MG PO TABS  GLUCOSAMINE CHONDROITIN COMPLX PO CAPS  LORATADINE 10 MG PO TA	Patient had a swollen gland in the right groin for several weeks before vaccination and was taking clindamycin for treatment of the fact that it had become red about 1 week before vaccination.	none			1						1	Dizziness; Face oedema; Injection site discomfort; Injection site erythema; Injection site pain; Injection site urticaria; Injection site warmth; Rash maculo-papular; Stomatitis; Throat tightness; Tongue disorder	FLU3~SANOFI PASTEUR~U2437AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0273~UNK~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|TYP~SANOFI PASTEUR~Z0663~UNK~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0307391	03/19/2008	CA	33.0	33		F	03/19/2008	The Patient was given .1 ml of Influenza Virus Vaccine intradermally.									Y	03/18/2008				UNK	UNK		Sinusitis				1						1	Incorrect route of drug administration	FLU3~SANOFI PASTEUR~U2498AA~UNK~ID~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0307395	03/19/2008	SD	0.33	0	.3	M	03/19/2008	I inadvertantly gave an influenza shot instead of a pneuococcal shot, to a 4 month old child.  The syringes look very similar, and are pre-filled.  The error was noticed as I went to enter the shots into the computer, after my clinic, at approximately 1500.  CDC was contacted RE: any possible adverse reactions, as well as, the parent, my supervisor, and adminstration.  A detailed report was put into Webcident.  Parent was also instructed to bring the child back to the hosptial for the pnuemococcal shot.  Immunization opportunities offered.									Y	03/19/2008	03/19/2008	0	NA	UNK	UNK	NA	None noted.	None noted.	NA~ ()~~0.00~Patient|NA~ ()~~0.00~Sibling|NA~ ()~~0.00~Sibling		1						1	Wrong drug administered	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B128AB~2~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2456AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF295AI~2~IM~LL~HIB (ACTHIB)~1|RV5~MERCK & CO. INC.~1619U~2~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0307936	03/19/2008		0.11			M	03/07/2008	Information has been received from a physician concerning a 11 month old male who was vaccinated with his third dose of RECOMBIVAX HB. Concomitant therapy that day included the frost dose of FLUZONE. Ten minutes post vaccination the child developed hives on his face, chest and extremities. Medical attention was obtained. Treatment was 3/4 teaspoon of BENADRYL. The final outcome was unknown at the time of this report. No further is available. No associated quality complaint report.				Y					U				Unknown	OTH	OTH			Unknown		WAES0701USA03397	1						1	Urticaria	FLU3~SANOFI PASTEUR~~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~~3~UN~UN~HEP B (RECOMBIVAX HB)~1	USA	Emergency room visit	Influenza
0307944	03/19/2008	NJ	65.0	65		F	03/07/2008	Information has been received from a registered nurse concerning an approximately 69 year old female with haemodialysis, hypertension and diabetes and no known allergies who in 2003 was vaccinated with 3 dose series of RECOMBIVAX HB and failed to seroconvert. The registered nurse reported that the patient's antibody blood test result that was drawn on 05-FEB-2007 was 7 but should be 10. Unspecified attention was sought. No product quality complaint was involved. Further information has been received from the nurse who reported that the patient received four doses of RECOMBIVAX HB in 2003. The patient had been vaccinated with hep b NOV 04, 2002 Lot # 0036M, on 06-DEC-2006 Lot#/0036M, on 06-JAN-2003, Lot # 0036 and on 07-MAY-2003 Lot # 0918M. The nurse noted that she did not known if these doses were for the first or second series for RECOMBIVAX HB. The patient was vaccinated on 24-JUL-2002 with pneumococcal vaccine lot # 1051L and vaccinated against influenza 22-OCT-2002, 03-OCT-2003 ( Lot # 765413), 08- Nov-2004, 10-OCT-2005 (Lot # U1777AA) and on 06-NOV-2006 with lot 2F601211. Additional information not expected.				Y					N	05/07/2003			serum hepatitis B 02/05/07 7 10 -	OTH	OTH		Haemodialysis; Hypertension; Diabetes			WAES0702USA01742	1						1	Hepatitis B antibody negative; Vaccination failure	FLUX~UNKNOWN MANUFACTURER~~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~MERCK & CO. INC.~0918M~4~UN~UN~HEP B (RECOMBIVAX HB)~1	USA	Emergency room visit	Influenza
0308053	03/19/2008	IA	65.0	65		F	03/07/2008	Information has been received from a registered nurse concerning a 65 year old female with hypothyroidism, osteoporosis and a history of headaches from antihistamines who on 27-APR-2007 was vaccinated with Recombivax HB.  On that same day, the patient was also vaccinated with Td (MSD), Fluvirin (unspecified), YF-Vax, typhoid vaccine live oral (Ty21a).  Concomitant therapy included thyroid medication and EVISTA.  On 29-MAY-2007, the patient had a follow-up doctor visit  and stated that on approximately 04-MAY-2007 she experienced dizziness and vertigo.  The patient was referred for follow-up to an ear, nose and throat physician and eye doctor.  Subsequently, the patient recovered from dizziness and vertigo.  Additional information has been requested.  Follow-up information has been received from a registered nurse concerning a 66 year old female with hypothyroidism, osteoporosis and a history of headaches from antihistamines who on 27-APR-2007 was vaccinated with her first IM dose of Recombivax HB (Lot# 655810/1022F) at 11:00 in the left deltoid.  Concomitant vaccinations administered on that same day at 11:00 included first dose of IM Td (Lot# TD-165) in the right deltoid, the first dose of IM Vaqta (MSD) (Lot# 652507/0886R) in the right deltoid, the first dose of Fluvirin (unspecified) (Lot# 71213) in the left deltoid, the first dose of SC YF-Vax (Lot# UF044AA) in the right deltoid, and 4 capsules of typhoid vaccine live oral (Ty21a) (Lot# 3001173).  Other concomitant drug therapy included thyroid medication and EVISTA.  On 04-MAY-2007 the patient felt like the room would spin while lying down.  The patient was referred for follow-up to an ear, nose and throat physician.  Subsequently, the patient recovered.  On 02-JUN-2007, the patient reported that she was found to have an inner ear problem.  On 02-JUN-2007 the patient was administered her second dose of Recombivax HB.  No problems were reported.  Additional information has been requested.				Y					Y	04/27/2007	05/04/2007	7	Unknown	PVT	PVT	(therapy unspecified); EVISTA	Hypothyroidism; Drug hypersensitivity; Osteoporosis	Headache		WAES0705USA05782	1						1	Dizziness; Inner ear disorder; Vertigo	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~71213~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~MERCK & CO. INC.~1022F~1~IM~LA~HEP B (RECOMBIVAX HB)~1|HEPA~MERCK & CO. INC.~0886R~1~IM~RA~HEP A (VAQTA)~1|TD~UNKNOWN MANUFACTURER~TD165~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~3001173~5~PO~MO~TYPHOID LIVE ORAL TY21A (NO BRAND NAME)~1|YF~SANOFI PASTEUR~UR044AA~1~SC~RA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0307148	03/20/2008	CA	24.0	24		M	03/20/2008	11 days after administration patient started getting right sided facial drooping and numbness, slurring of his speech, and difficulty closing eye completely. DX- Bell's Palsy Tx- Acyclovir 800mg 1 tab daily times 10 days, prednisone 60mg for 3 days then 40mg for 3 days then 20mg for 3 days. Refresh tears and e-mycin ointment. Patching at night.				Y				Y	U	11/28/2007	12/10/2007	12	CBC, LFTs, Chem panel, ESR, RPR all drawn and within normal limits	MIL	MIL	None	None	None			1						2	Facial palsy; No therapeutic response; Dysarthria; Eye disorder; Facial palsy; Full blood count normal; Hypoaesthesia facial; Laboratory test normal; Liver function test normal; Red blood cell sedimentation rate normal; Syphilis test negative	FLUN3~MEDIMMUNE VACCINES, INC.~500496P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500496P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|MEN~UNKNOWN MANUFACTURER~UNK~UNK~IM~LA~MENINGOCOCCAL (NO BRAND NAME)~2	USA	Disabling	Influenza
0307495	03/20/2008	CA	0.5	0	.5	F	03/15/2008	Seizure				Y					Y	03/14/2008				PUB	PUB		None	None			1						1	Convulsion	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B138BA~3~UN~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2475BA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C45891~3~UN~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0849F~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0307527	03/20/2008	VA	41.0	41		M	03/20/2008	Nov 13, 2007 Flumist vaccination. He stated no problems with past IM flu vaccinations.  Following the Flumist, he remembers not feeling well for the next 12 hours as corpsmen advised. Within 1 days post vaccination he noted increasing blurry vision with elevation of BP >150 systolic. He described the blurry vision while reading and having difficulty focusing having to move his eyes about to refocus. Approximately 2 1/2 days post vaccination while working as correctional officer at a brig he passed out.  He was transferred to Hospital where he was monitored for 4-5 hours and sent home.  There he complained of a severe headache but cannot remember details. He does remember eyes were sensitive to light as was his hearing. He experienced intermittent episodes of headaches and visual blurry over the next two months before symptoms resolved. He stated eating lots of garlic which made these symptoms resolve.				Y					Y	11/13/2006	11/13/2006	0	unknown-unavailable Hospital	MIL	MIL	denied	denied	Hx typhoid vac allergy 1991, sleep apnea 2006, IBS	convulsion, fever~Typhoid Vi Polysaccharide (no brand name)~UN~0.00~Patient		1						1	Blood pressure increased; Headache; Hyperacusis; Loss of consciousness; Malaise; Photophobia; Vision blurred	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0307537	03/20/2008	NY	1.08	1	.1	M	03/20/2008	Fever 105.2 irritability unconsolable. Hospital referral.				Y					Y	03/12/2008	03/14/2008	2	ED Referral	UNK	UNK		Viral Exanthem	Allergy-ceftriaxone-urticaria	fever 105~Polio Virus, Inact. (Ipol)~3~0.90~Patient		1						1	Crying; Irritability; Pyrexia	FLU3~SANOFI PASTEUR~UT2456EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0307706	03/21/2008	NY	20.0	20		F	03/07/2008	Immediately after vaccines given pt c/o not feeling well and pale, non-responsive, placed on floor O2 via mask 10L administered and pulse ox 99, glucose 82, BP 130/80, P 92. Pt responsive. Epipen 0.3mg IM LT, Benadryl 50mg IM RT, BP 116/70. Ambulance transported and pt to respond for evaluation.				Y					Y	03/07/2008	03/07/2008	0	None	PUB	PUB	Prenatal vits	Pregnancy EDC 10/27/08				1						1	Malaise; Pallor; Unresponsive to stimuli	FLU3~SANOFI PASTEUR~U2461CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB107BA~1~IM~LA~HEP A + HEP B (TWINRIX)~1|TD~SANOFI PASTEUR~U1956DA~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0307708	03/21/2008	NJ	0.6	0	.6	M	03/17/2008	About 5 min after Flu vaccine after vomited x2 and looked very pale - after 15 min vomited more and looked pale and lethargic. No stridor, wheeze, rash. Given epinephrine to 2 in office EMTS took to hospital, he received fluids.				Y					Y	11/06/2007	11/06/2007	0	Allergy testing negative	PVT	PVT	None	None	None			1						1	Allergy test negative; Lethargy; Pallor; Vomiting	FLU3~SANOFI PASTEUR~U2436AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0306736	03/22/2008	MO	75.0	75		M	03/22/2008	1 WEEK AFTER AMINISTRATION PT COMPLAINED OF ARTHRITIS IN BOTH WRISTS, MD REPORTING STATES THAT PATIENT NOW HAS EARLY ONSET RHEUMATOID IN BOTH WRISTS - UNSURE IF RELATED TO VACCINE.  5/1/09MR received including PCP and rheumatology consults 2/27/08-4/2009. Pt initially presented 2/27/09 with c/o reaction to flu shot. Pt reports hand swelling which began the day of the injection. The other hand began swelling the next day which was later developed into bilateral arthritis of the wrists, currently dx with RA. PE WNL. Assess:  Wrist pain. glucose intolerance.  Rheum consult 4/22/08 with DX: RA.  High titre ANA with centromere pattern. PE (+) for bilateral wrist warmth, swelling and tenderness. Tx with MTX/Folic Acid and Pred.				Y					U	01/10/2008	01/17/2008	7	CONTACT MD ON FDA REPORT. Labs and diagnostics:  RF 15. anti-CCP Ab (+).  ANA 1: 1280-centromere pattern. X-ray wrist/hands (+) for arthritic changes.	UNK	UNK	ATORVASTATIN/AMLODIPINE/SENNA/ASA/APAP		LOVASTATIN/SIMVASTATIN ALLERGIES  HTN, HYPERLIPIDEMIA/ENLARGED PROSTATE/GERD. PMH:  HTN, HLP, BPH, GERD, AAA, glucose intolerance.			1						2	Arthralgia; Rheumatoid arthritis; Rheumatoid arthritis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA320AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA320AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Emergency room visit	Influenza
0307770	03/23/2008	FL	39.0	39		F	03/23/2008	The day after the vaccine, my left arm hurt.  Approximately two to three weeks later, I experienced extreme fatigue and muscle weakness.  I seen three doctors before going to the clinic.  My muscles wasted away in my shoulders and my left hip was in pain and I limped.  I could not dress myself, tie my shoes, wash my hair and could barely drive my vehicle.  I am unable to walk up stairs and walk a long distance.  I fall alot and am not strong enough to pick myself up.  My shoulder bones hurt and ache constantly.  I was put on Prednisone in June of 2007 and underwent pt and ot therapy, to no avail.  In December of 2007, I was also put on Lyrica and Boniva in February.  I went back to the Clinic and they now put me on Methotrexate along with the prednisone, Lyrica and Boniva.  I am still not functionable.  04/04/2008 MR received for several OVs between 4/19/2008 and 2/28/2008 with DX: necrotizing myopathy. Pt reports myalgias and upper extremity weakness beginning a few days after Flu shot  12/11/06 and worsening over the next months.  Requiring assistance with ADL and work related activities. Significant functional impairment noted.  PE(+) for Proximal upper limbs/shoulder girdle atrophy with significant weakness.  Unable to fully abduct shoulders. Proximal weakness of lower limbs. Some improvement with prednisone, however has had several recent falls. Sleep is disturbed. Appetite poor.  Depressed affect. Pt developed rash on chest 2/2008 as well as erythema over the knuckles. ? dematomyositis.				Y				Y	N	12/11/2006	12/30/2006	19	Creatine Kinase levels were in the 7,000's in June of 2006.  Elevated AST levels (74) Bone Density test showed bone loss in neck and femurs, spine was at 0.  PET scan showed no signs of cancer.  All Hepatitis tests were negative along with HIV.  Muscle Bioposy shows muscle damage of unknown kind,  Labs and Diagnostics:  EMG abnormal: severe myopathy with fibrillation potentials suggestive of ongoing mild necrosis or fiber splitting.  Muscle biopsy abnormal: Myopathy, active, severe type undetermined w/o evidence of inflammation.  Type 2B Fiber atrophy.  Denervation atrophy. PET scan No evidence of hypermetabolic foci.  CK 2831-5000.  AST 190. ALT 165. Creatinine 0.4. Aldolase 104.3 (H). A2 Glob 1.1 (H).	UNK	UNK	none	none	none. PMH:  smoker, 2 miscarriages. NKDA.	none~ ()~~0.00~Patient|none~ ()~~0.00~Sibling|none~ ()~~0.00~Sibling		1						1	Activities of daily living impaired; Arthralgia; Aspartate aminotransferase increased; Biopsy muscle abnormal; Blood creatine phosphokinase increased; Bone density decreased; Bone pain; Fall; Fatigue; Gait disturbance; HIV antibody negative; Hepatitis A antibody negative; Hepatitis B test negative; Hepatitis C test negative; Muscle atrophy; Muscular weakness; Pain; Pain in extremity; Positron emission tomogram normal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~70739~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0307947	03/24/2008	ME	1.6	1	.6	M	03/17/2008	Patient received DTaP, MMR and VARIVAX flu on 03/07/08 and had a febrile seizure 3/16/08.				Y					Y	03/07/2008	03/16/2008	9	None	PVT	PUB	None	None	Tongue tied			1						1	Febrile convulsion	DTAP~SANOFI PASTEUR~C2800AA~4~UN~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2437AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1325F~1~UN~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1762U~1~UN~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0307948	03/24/2008	MN	2.0	2	.0	M	03/19/2008	Child had received FLUZONE last year so one dose of vaccine was required for this year.  Received .5cc dose instead of correct dose of .25cc.  No adverse reaction reported.									Y	10/26/2007			None	PUB	PUB	None	None	None			1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~U2490AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0307955	03/24/2008	NC	0.5	0	.5	M	03/18/2008	Began yellow runny stools after dose #3 ROTATEQ 11/29/07 given Amoxicillin, 12/6/07 intussusception bowel reduced in ED.  4/8/08 Reviewed hospital medical records of 12/11/2007. FINAL DX: Intussusception, enema reduced Records reveal patient experienced intermittent screaming, inconsolable crying, restless, vomiting, bloody/mucousy stool, diet refusal, red blotchy rash over face & arms x 1 day.  Had recent watery diarrhea & had been on antibiotics recently for sinus infection.  Formula changed to soy recently.  Peds surgery consult done.  Admitted overnight s/p IS reduction.				Y	Y	1			Y	10/29/2007	11/01/2007	3	Stool cults- O:P (-) C. diff (-); Rotavirus (-); (-) Salmonella (-); Shingella  LABS: US of abdomen (+) IS in LLQ.  Air BE enema reduced ileocecal IS.  WBC 26.4 (H).	PVT	PVT	None	None	None			1						1	Clostridium difficile toxin test; Culture stool negative; Diarrhoea; Rotavirus test negative	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B130AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2467AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B701436~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0973U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0307989	03/24/2008	IA	54.0	54		F	03/24/2008	Within 2-3 weeks of immunization, pt. began experiencing several illnesses, one following the other.  First, approx 11/7/07 bronchitis and laryngitis, 3 weeks later, laryngitis with symptoms of strep throat, 3-4 weeks later bronchitis, 3 weeks later severe coughing and repeated laryngitis, 2 weeks later double ear infection and double sinus infection with accompanying cough and post nasal drip.  2 weeks later continued sinusitis accompanied with severe cough and strep throat.  10 days later pt. still has sore throat and severe cough accompanied by laryngitis.				Y					N	10/25/2007	11/06/2007	12		UNK	UNK	HCL, Lisinopril, Zyrtec, Prevacid, Trazadone, Effexor XR, Clonazepam, Potassium Chloride, Estradiol, Norethindrone, Advair 250/50 administered daily and Proair PRN	Panic attacks, depression, asthma, indoor and outdoor allergies, menopause high blood pressure, low potassium without supplement, mitral valve prolapse.	Panic attacks, depression, asthma, indoor and outdoor allergies, menopause high blood pressure, low potassium without supplement, mitral valve prolapse.			1						1	Bronchitis; Cough; Ear infection; Laryngitis; Pharyngitis streptococcal; Postnasal drip; Sinusitis	FLUX~UNKNOWN MANUFACTURER~unknown~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0307996	03/24/2008	CA	5.0	5		F	03/24/2008	Left arm red, painful, swollen at vaccine injection site 3 days ago. No fever. Upper arm with 3 inch area of A/P cellulitis; Keflex 250mg PO Tid cool compress Qid; Follow up 48 hours if not better.									U	03/21/2008	03/22/2008	1		PUB	PUB						1						1	Cellulitis; Injection site erythema; Injection site pain; Injection site swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B073AA~5~UN~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2480BA~2~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB249AB~3~UN~RA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~A1188-2~5~UN~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0866U~3~UN~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1799U~2~UN~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0307997	03/24/2008	MA	3.0	3		F	03/14/2008	Facial rash and itch; Upper lip swelling; Hx of drool				Y					Y	03/02/2008	03/13/2008	11		PVT	PUB	None	None	None			1						1	Lip swelling; Pruritus; Rash	FLU3~SANOFI PASTEUR~U2516AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0307998	03/24/2008	MI	29.0	29		M	03/20/2008	11-30-07 presented to ER with diplopia (double vision) was given Compazine 2.5mg thru IV in ER. Referred to Neurologist same day. 12/05, 12/06, 12/07/07 given Soludro Medrol 1g IV infusion x 3 days. Follow up with Dr. bi-weekly. Follow up was also done with Ophthalmology. Follow-up with neurosurgeon on 12/18/07 and 2/05/08. Double vision cease on 12/21/08.				Y					Y	11/16/2007	11/30/2007	14	11/30 - CT and Lab work, MRI done with and without contrast on 12/01, 12/06, and 1/28/08. Auditory brain stem evoke and visual evoke on 12/7/07	PVT	UNK	None	No		None~ ()~~0.00~In Patient		1						1	Brain stem auditory evoked response; Computerised tomogram; Diplopia; Laboratory test; Nuclear magnetic resonance imaging; Visual evoked potentials	FLU3~SANOFI PASTEUR~U2446Aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0304836	03/25/2008	CA	23.0	23		F	03/25/2008	ONE HOUR AFTER RECEIVING INFLUENZA VACCINATION PATIENT BEGAN TO FEEL DIZZY AND RIGHT SIDE OF BODY BECAME RED/HOT TO TOUCH.									Y	11/02/2007	11/02/2007	0	NONE	MIL	MIL						1						2	Dizziness; Erythema; Skin warm; Dizziness; Erythema; Skin warm	FLUN3~MEDIMMUNE VACCINES, INC.~500496P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500496P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0308083	03/25/2008	NC	59.0	59		F	03/11/2008	Patient received flu shot approximately 12:00 noon on 3/10/08.  First noticed systemic rash last PM - Presented into hospital after overall symptoms burning rash at 11:45AM 3/11/08.  Seen by N.P. - advised to take over the counter 50mg Benadryl and go to ER if difficulty breathing or swallowing.									Y	03/10/2008	03/10/2008	0	None	OTH	PVT	B.P. medication; Cholesterol medication	None	Patient states allergic to bees and has had similar reactions.		NC08037	1						1	Burning sensation; Rash generalised	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA043AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0308084	03/25/2008	NC	10.0	10		F	03/12/2008	None - vaccine expired 1/16/08 and vaccine given 2/7/08.									U	02/07/2008			N/A	PVT	PVT	Elecon cream	Eczema	None		NC08036	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500481P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0308094	03/25/2008	SC	67.0	67		F		Patient states she received 2 immunizations Dec. 3 07, which she believes caused inflammation and tenderness with dorsal aspect (L) shoulder and especially proximal - lateral (L) arm. We are referring to doctors as result of ongoing tenderness and decreased ROM.				Y					N	12/03/2007	12/04/2007	1	Decreased ROM and tender (L) shoulder	PUB	UNK						1						1	Inflammation; Injected limb mobility decreased; Tenderness	FLU3~SANOFI PASTEUR~U2527AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0880F~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TTOX~SANOFI PASTEUR~U1954BB~1~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0308214	03/26/2008	SC	88.0			F	03/20/2008	This case was received from a consumer on 22 January 2008.  An 88-year-old female patient, with a history of hypertension, received a left deltoid injection of Fluzone (lot number U2506AA) in November 2007; route and exact date of administration were not provided.  Approximately two days after vaccination, the patient began complaining of pain in her left arm.  The pain subsequently spread to the right arm, shoulders, and lower extremities.  The patient was seen by a physician, and was being treated with Celebrex and Ulhamer.  Bloodwork and x-rays had been performed, but results were not provided.  At the time of the report, the pain was ongoing, and the patient was scheduled to see a neurologist.  Follow-up information was received 04 March 2008 from a consumer.  According to the reporter, the patient had been seen and evaluated by the neurologist.  Results of the neurologist's consultation were not provided.  The reporter indicated that the patient's condition had worsened and described the patient as having Flu like symptoms and clarified flu like symptoms as constant aches and pains.  For about a month now, the patient had episodes that come and go, which consisted of hoarseness where she can barely speak.  No further information was provided at the time of the report.  Follow-up information was received from a health professional on 17 March 2008.  Based on the new information received, the case was determined to be serious.  SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  According to the reporter, the patient had severe diffuse myalgias with proximal muscle weakness and an increased CRP.  An electromyelogram and nerve conduction studies showed polyneuropathy.  The patient still had ongoing pain, and treatment included Ultram (previously reported as Ulhamer), Lyrica, Cymbalta, and Motrin.  Based on the available information, the patient had been diagnosed with cervical spine pathology, stenosis as alternative diagnosis.  The patient had been seen by a neurologist, and contact information was provided.  The event had not yet resolved.				Y					N				CRP elevated: EMG/NCS showed polyneuropathy	PUB	OTH	ATENOLOL, IBUPROFEN		Hypertension (controlled)		200800239	1						1	C-reactive protein increased; Cervical spinal stenosis; Dysphonia; Electromyogram abnormal; Influenza like illness; Muscular weakness; Musculoskeletal pain; Myalgia; Nerve conduction studies abnormal; Pain; Pain in extremity; Polyneuropathy; Speech disorder; Spinal disorder	FLU3~SANOFI PASTEUR~U2506AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0308219	03/26/2008	UT	1.52	1	.5	M	03/04/2008	Child given age-inappropriate Influenza vaccine incensed for age 4 + years.  No adverse event reported.									U	02/04/2008				PUB	PUB	Unknown	None	Unknown			1						1	Incorrect dose administered	DTAP~SANOFI PASTEUR~C2606AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80956~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~A01262~3~IM~UN~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~B54015E~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0308221	03/26/2008	ID	6.0	6		M	03/21/2008	Post-vaccine cellulitis left deltoid about 14-16 hrs after varicella and influenza to left deltoid. 14x15 cm. diameter. ? Just local reaction									U	03/20/2008	03/21/2008	1		PVT	UNK	None	No	No			1						1	Injection site cellulitis; Local reaction	FLU3~SANOFI PASTEUR~U2532AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1780U~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0308260	03/26/2008	ND	18.0	18		F	03/25/2008	(3-20-08) Patient noticed rash on both arms when awaking pruritic - Spread to entire body by that evening. Also developed blisters in mouth with lips swelling that evening (3-20-08). States Benadryl on 3/22/08. Began improving on 3/23/08.									Y	03/19/2008	03/20/2008	1		OTH	PVT	Started on Cephalexin 3/10/08.	Tonsillitis (3-10-08); 3-19-08 Improved.				1						1	Lip swelling; Oral mucosal blistering; Pruritus; Rash; Rash generalised	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA30AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0299447	03/27/2008	GA	46.0	46		F	03/18/2008	This case was reported by a physician and described the occurrence of facial rash in a 46-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 8 November 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown, left arm). On 15 November 2007, 7 days after vaccination with Fluarix, the subject experienced facial rash. The subject was treated with Xyzal. At the time of reporting the event was improved. The physician considered the event was possibly related to vaccination with Fluarix. Follow-up information was received on 11 February 2008 via a physician, who reported that no biopsy was performed on the rash. At the time of reporting, the event was resolved.				Y					Y	11/08/2007	11/15/2007	7	UNK	PUB	PUB		Unknown	No relevant medical history was reported. The patient had previously received flu shots without experiencing any adverse events. The subject had no adverse events following receipt of prior immunizations. A total of three patients had experienced adverse events following vaccination with Fluarix. See A0698846A and A0698853A.		A0698850A	1						2	Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Emergency room visit	Influenza
0303783	03/27/2008	MI	38.0	38		M	03/18/2008	This case was reported by a pharmacist and described the occurrence of joint pain in a 38-year-old male subject who was vaccinated with Fluarix (GlaxoSmithKline).  On 10 January 2008 the subject received a dose of Fluarix at 0.5 ml in the left thigh.  On the same day of Fluarix vaccination, 10 January 2008 (time not known) the subject experienced joint pain and limitation of movement.  Pain in the shoulder joint and restricted shoulder movement at the joint were described.  All events except pain in the shoulder joint were improved at the time of reporting.  Pain in the shoulder joint was unresolved.  Follow-up received on 20 February 2008 via the pharmacist.  She reported that the subject received Fluarix in the left deltoid.  She indicated that the outcome of the events were unknown at the time of this report.  She noted that pain in the shoulder joint was unresolved and movement was still restricted.  She considered that the events were related to the use of Fluarix.									N	01/10/2008	01/10/2008	0	UNK	OTH	OTH		Unknown	The reporter was not aware of any relevant medical history.  The subject had previously received flu shots, but the reporter not aware of any reactions experienced following these flu shots.		A0706151A	1						2	Hypokinesia; Pain in extremity; Arthralgia; Hypokinesia; Joint range of motion decreased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU319BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA319BA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA		Influenza
0308327	03/27/2008		31.0	31		F	03/26/2008	Information has been received from a certified nurse practitioner concerning a 31 year old female with no pertinent medical history reported. The patient had her last menstrual period on 20-JAN-2008. On 30-JAN-2008, the patient was vaccainted with MMR II (lot # 1312U). Concomitant therapy also administered on 30-JAN-2008 included TWINRIX, influenza virus vaccine (unspecified) (manufacturer unspecified). poliovirus vaccine inactivated (Vero) (manufacturer unspecified), diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified), and typhoid vaccine live oral (Ty21a) (manufacturer unspecified). Concomitant therapy administered on 06-FEB-2008 included Japanese encephalitis virus vaccine (manufacturer unspecified), and rabies vaccine (unspecified) (manufacturer unspecified). Subsequently, she became pregnant. Her estimated date of delivery was 26-OCT-2008. On 27-FEB-2008, the patient had a pregnancy test. On 28-FEB-2008, the patient miscarried. Unspecified medical attention was sought. Subsequently, the patient recovered. Upon internal review, the spontaneous miscarriage was determined to be an Other Important Medical Event. Additional information has been requested.				Y					Y	01/30/2008	01/30/2008	0	beta-human chorionic 02/27/08	OTH	OTH		Pregnancy NOS (LMP = 1/20/2008)			WAES0803USA01753	1						1	Abortion spontaneous; Drug exposure during pregnancy; Pregnancy test	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~HEP A + HEP B (TWINRIX)~1|IPV~SANOFI PASTEUR~~UNK~UN~UN~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|TDAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~TDAP (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~UN~UN~TYPHOID LIVE ORAL TY21A (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0308363	03/27/2008	ME	44.0	44		F	03/21/2008	Injection site soreness-worsened within 2 weeks.  Low grade fever for 2 weeks, fatigue, malaise, did not feel right-left arm pain 9 on 10 scale for weeks...see attached journal.  As of March 21 2008 arm still sore and weak.  November 14, 2007 Had annual flu shot.  Experienced injection site tenderness that evening and next day.  Nothing unusual.  Have received about 8 consecutive flu shots in the past.  Arm soreness progressively got worse over the next week and 1/2.  Peaked at 10 days.  Pain 9.5 on 10 scale.  Deltoid, bicep and tricep pain; deep ache, burning.  Adduction, abduction of arm in all planes difficult and very painful.  Supine position most uncomfortable; hard to get a nights sleep.  Simple things like driving, taking shirt off, reaching for something; very difficult and painful.  Ran low fever for two weeks.  Self/Home remedies: Tried ibuprofen, no relief.  Heat therapy; no relief (possibly worse).  Chiropractic visit; gentle range of motion; no relief.  Took old prescription Flexeril one night to help pain and sleep; no pain relief but I slept.  Hot bath; no relief.  Analgesic rub (Biofreeze); no relief.  Saw massage therapist on Dec 5; relief during visit only.  November 26: Went back to doctor's office on Monday, November 26 as a walk-in asking to see a doctor about an adverse reaction I was having.  Saw Dr.  He read the insert on the vaccine package about side effects and questioned whether I could have brachial plexus neuropathy.  Recommended I have blood work done at hospital to check protein levels and scheduled an appointment for Dec. 7, 2007 (when results would be in 10-14 days).  He told me to keep the arm moving so it wouldn't seize up.  Have been doing light workout for past two weeks to keep muscles moving and to avoid atrophy.  Chest press, upright row, deltoid raises (very difficult), low row, tricep and bicep exercises.  Week of December 1, 2007 Pain is reduced to 5 or 6 on the scale.  Simple movements still painful and awkward.  Night time seems worse.  Don't feel that I am progressing to get better.  Plateau?  Chronic pain affecting me; just need arm to stop hurting and work right.  Exhausted at days end.  December 7, 2007 Appointment with Dr. to go over blood panel results.  The blood work was excellent.  No issues.  Dr. ordered a CT scan.  Had CT scan that afternoon.  December 10, 2007 Called Dr. for CT results.  Scan showed swollen lymph glands left side of chest.  All else looked good.  Nothing on scan to point directly to shoulder pain.  Dr. scheduled appointment for December 13 at which time he went over the results in depth of CT scan and prescribed Vicodin for pain.  He referred me to Dr. (neurologist) and we scheduled an appointment for mid Jan. 2008.  December 14, 2007 Saw Reiki practitioner to work on my arm.  Results were minimal.  Slight improvement in ROM that day and next.  Pain did not improve.  Very discouraging.  December 18, 2007. Pain is persistent and not improved. Having trouble sleeping and performing job.  Simple movements like removing shirt, tucking in shirt and opening car door very painful.  Called Dr. to prescribe a pain med that wouldn't give me insomnia like the Vicodin on advice of pharmacist who said that it affects some people in that manner.  Dr. prescribed Percocet.  I am continuing to work the muscles in a light manner, with no weights, to keep the muscles from atrophy.  December 20, 2007 Saw massage therapist to work on arm.  This form of therapy seems to offer the most immediate relief and comfort, even though it is only temporary.  I'm going with it though...it's a few hours of relief and I'll take anything at this point.  Also, starting with head congestion today.  Feels like a cold coming on.  December 21, 2007 Full blown cold or virus happening.  Severe head congestion, fever, chills, body aches.  Feel awful...good thing I got the flu shot.  Ha ha ha.  December 24, 2007 All of the above symptoms with unproductive cough and weakness.  Ears hurt.  Appetite is not good...just want to sleep all the time.  Cancelled all appointments with clients for this week.  Just going to rest.  Arm still sore and painful when abducted away from body.  Not as painful during night though...not keeping me awake anymore.  Hard to be a personal trainer with an arm that doesn't work right.  December 25, 2007 Still feeling sick.  At the Christmas gathering, I was just sitting there and I started to have neck pain on right side.  I started rubbing it...became headache.  Told person I wanted to leave and asked someone for some ibuprofen.  She gave me a Tylenol/Percocet pain killer instead.  Did not touch it.  Had to stop at gas station where I downed 4 200 mg ibuprofen.  Felt nauseous and had to cradle my head in my hands.  Could not look at light.  Longest hour long drive ever to get home.  Just climbed into bed and headache slowly abated when lying down.  Had plenty of headaches throughout my life...this was different.  December 26 and 27, 2007 Still feeling sick and weak but slightly better.  Nose is congested and probably have sinus infection as discharge is greenish/yellow/slightly bloody.  Keep getting sharp pain in neck when I turn it sometimes.  Scary.  Did I pull something?  Stoke or aneurysm precursor?  December 31, 2007 Still feeling strange.  Nose congestion, short of breath, arm aches, and lack of energy.  Decided to walk about 4 miles round trip today to test my strength and cardio.  Had some trouble catching my breath but pushed on.  Tired when I got back to the house and felt chilled.  Tried to shovel some...very difficult.  Kept arm close to body and avoided abduction.  Very sore in deltoid, bicep region of left arm that night.  Needed ibuprofen.  So hard to do just the basic things like tucking shirt in, removing shirt over head, reaching for a glass.  Disheartening.  Went out for New Year's Eve.  Watching ice skating.  Felt uncomfortable in my stomach (like belt was too tight).  Went to dinner and started having stomach cramps.  Hardly ate any of my entree.  Went home, got into comfortable clothes, but didn't even feel like having champagne (very unusual).  2am woke up to use the bathroom...had diarrhea and felt weak.  Can't believe I'm coming down with something else.  Immune system must be shot.  January 1, 2008 Woke up feeling like I had been run over by a truck.  My whole body hurt; even my skin.  More diarrhea and nausea.  Felt chilled and weak.  By afternoon, felt I was dealing with flu bug or food poisoning.  Fever 100.5 lots of diarrhea, nausea (can hardly get water down), achy and body aches.  Went to bed.  I mustn't have any immune system left...I seem to be getting everything out there.  January 2, 2007 Nausea less intense today.  Don't feel like eating but will try some Jello and maybe soup tonight.  Stomach making lots of noise and some diarrhea still but less in quantity.  Nap in afternoon and soup stayed down at night.  Feel weak and still tired.  Weird chest discomfort when recumbent.  Woke up in middle of the night with it.  January 3, 2008 Feel better this morning.  Still weird in stomach and weak and dizzy.  Determined though to do some laundry, dishes, pay the bills, etc...small house chores.  Ok until I ate a can of chicken noodle soup.  Then stomach started with mild discomfort and churning.  Guess I'm not out of the woods yet.  I have to get better soon...I have to work next week.  Tomorrow I will go run some errands in town and see how that goes.  (Chest discomfort in morning before getting out of bed).  I think it's time to see Dr. to see what's holding me back from recovering from this.  January 4, 2008 Went to see Dr. about this bug that won't go away.  He's so good about getting you in the same day when needed.  We did chest xray to rule out pneumonia since I'm having that discomfort in my chest (left side, middle) and the xray was fine.  He put me on a z-pak of antibiotics.  Hopefully this will get the recovery process going.  I told him the arm was slowly improving and today I was able to tuck my shirt into my pants without too much pain.  That's a big improvement over a week ago...so maybe things are going to be ok.  January 10, 2008  Last dose of antibiotics was Tuesday and boy did that get me back on my feet quick.  I feel like I have a new lease on life.  Been working this week and did a fitness workout with the teachers.  I was very shaky and my left arm didn't want to work too good on some of the exercises but I persevered.  I need to get stronger.  I couldn't complete a tricep kickback with 3 pounds, so I reduced the weight to 1.5 pounds.  Much better but certainly pathetic considering what I usually do.  Still hard to open a car door and can't remove shirt over my head still.  Uncomfortable when in bed laying down on my back and abduct arm away from body (ie; reaching over to grab the blanket and pull over to me).  I hope I get everything back over time.  January 15, 2008  Discomfort in the arm is no different than a week ago...feels like a plateau.  My arm(s) shake a lot when I am doing workouts with my clients using light weights.  They have noticed I am still not well.  I still have pain when I go to move it during the night.  It's uncomfortable and not what it once was.  January 17, 2008 Went to see Dr. (neurologist).  He confirmed that he believes it is an allergic reaction to the flu vaccine I received and that there is inflammation in the area of the deltoid with radiating pain in left upper arm.  Numbness on back of shoulder present also.  He put me on DayPro for two weeks and hopes to ease the inflammation with this prescription.  He wants a follow-up call from me at the end of the prescription with results.  If no change he will do an EMG (NCV) test.  January 29, 2008 My arm started to become more sore today.  Night time was very uncomfortable again.  I can't think of anything different I've done over the last few days.  February 5, 2008 The arm has been pretty sore for the last five days.  Feels like a relapse heading back towards where I've just been with it.  I've also come down with a cough over the last few days.  Maybe I'm getting that cold that's been going around.  Just don't feel myself.  Called the neurologist on the 1st, and he scheduled an EMG for the end of February.  Hopefully, I won't need it because my arm will be better by then.  Wishful thinking?  February 6, 2008 Met with Dr. about some lumps on my right ear.  She thinks they are sebaceous cysts and has scheduled outpatient surgery for Friday the 15th.  Met with Dr. about rectal bleeding that I believe could be from hemorrhoids or anal fissure.  He did digital exam, didn't see anything serious but ordered up a rigid sigmoidoscopy for Feb 20th.  Not looking forward to that.  February 11, 2008 Over this weekend my cough was just terrible.  I felt down and super fatigued.  I had no energy all weekend.  Today, Monday, I'm feeling a little better.  I have modified my diet to a protein type diet and hope this helps in the healing process of all the things that are wrong with me.  I'm getting tired of being tired.  February 20, 2008 Last Friday had cysts removed from ear.  Stitches will come out in 10 days.  No complications.  Had sigmoidoscopy done today.  Not fun but doctor didn't see anything that needs further attention.  He noticed scarring where he thinks I had a small fissure which self healed over the last two weeks due to increased fiber intake (Metamucil) and relaxed diet.  The arm is still feeling different than the other one and I can not use the same weights that I do with the right arm during workouts.  EMG is scheduled for next week and I will keep the appointment.  I would like to know if there is damage to something which is keeping me plateaued at this level with it.  March 4, 2008 EMG results came back normal.  So that leaves me with assuming that my arm pain and myalgia will hopefully go away on its own someday.  I'm going to think positive thoughts and work it as hard as I can tolerate.  I hope someday it is normal like it use to be.  I know it was caused by a reaction to the flu shot I had so I will fill out an Adverse Reaction Form and send it in.  I'll never get another flu shot!  5/01/2008 MR received for OV 1/17/2008 with Dx: Myalgia injury site of Flu shot. Pt presented with 2 month hx of severe left deltoid pain which has been improving. Difficulty with activities such as removing shirt and physical work activities. Some numbness. PE (+) for point tenderness in the deltoid and limited abduction.  Tx with anti-inflammatory. 1/20/2010 Left arm is still sore. Nighttime is worse. Sometimes its very achy but less than 6 mos. ago, still trouble with abduction and strenght is less than it was.  Follow-up: I am the same as last reported. This adverse reaction (left arm pain and weakness) is problematic as I do personal training. It doesn't look good when the client can do more dips and pushups than the trainer can!				Y				Y	N	11/14/2007	11/20/2007	6	Complete book workup; CT chest; EMG left arm all normal. Labs and Diagnsotics:  NCS normal. EMG normal.	PVT	OTH	Yaz birth control; Levoxyl; Cytomel	None	None. PMH: Partial thyroidectomy.			1						1	Abdominal pain upper; Activities of daily living impaired; Allergy to vaccine; Anal fissure; Asthenia; Blood test normal; Brachial plexus injury; Burning sensation; Chest discomfort; Chills; Computerised tomogram normal; Cough; Cough; Decreased appetite; Dermal cyst; Diarrhoea; Dizziness; Dyspnoea; Ear pain; Electromyogram normal; Fatigue; Fatigue; Feeling abnormal; Food poisoning; Headache; Hypoaesthesia; Impaired work ability; Inflammation; Injected limb mobility decreased; Injection site pain; Insomnia; Lymphadenopathy; Malaise; Mobility decreased; Muscular weakness; Myalgia; Nasal congestion; Nasopharyngitis; Nausea; Neck pain; Neuropathy peripheral; Pain; Pain in extremity; Photophobia; Pyrexia; Rectal fissure; Rectal haemorrhage; Rhinorrhoea; Scar; Sigmoidoscopy; Sinus congestion; Somnolence; Stomach discomfort; Tremor	FLU3~SANOFI PASTEUR~U2502AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0308366	03/27/2008	TX	31.0	31		F	02/13/2008	Employee given Flu shot on 2/11/08 at 3:50/pm and at 4pm she stated she felt flushed and nauseated. Her B/P was up at 162/92 p 110 R 24. Employee stated her tongue felt thick. I gave her a dose of Solu Medrol 125 mg im and called 911 for assistance. She went to ER and received. Solu Medrol Epi Follow-up: It has happened 2x the past 2 years and I don't think drive by flu shots should be permitted.					Y				Y	02/11/2008	02/11/2008	0		UNK	UNK						1						1	Blood pressure increased; Flushing; Nausea; Tongue disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA0B5AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation	Influenza
0308374	03/27/2008					F	03/18/2008	This case was reported by a pharmacist and described the occurrence of headache in a female subject of unspecified age who was vaccinated with FLUARIX, GlaxoSmithKline.  On an unspecified date the subject received unspecified dose of FLUARIX (unknown).  At an unspecified time after vaccination with FLUARIX, the subject experienced headache.  The subject was treated with sumatriptan succinate (Imitrex).  At the time of reporting the outcome of the event was unspecified.				Y					U				Unknown	OTH	OTH		Unknown	Relevant medical history, vaccinations and concomitant medications were unknown.  The reporting pharmacist was concerned about the subject daily use of Imitrex at the maximum daily dose.		A0702203A	1						1	Headache	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0308376	03/27/2008					U	03/18/2008	This case was reported by a pharmacist and described the occurrence of adverse event in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (manufacturer unspecified).  On an unspecified date the subject received unspecified dose of influenza virus vaccine (unknown).  At an unspecified time after vaccination with Influenza virus vaccine, the subject experienced adverse event.  The reporter stated that he did not know the specifics of the type of events that were experienced by this subject as a consumer reported to the pharmacist that her co-worker experienced similar problems after he or she received a flu vaccine (unknown which manufacturer).  This particular subject had experienced arm soreness at the injection site, arm tenderness at the injection site, arm muscle weakness, especially at night, could not use her arm very well and arm weakness.  Details of this case are found in case number A0709413A.  At the time of reporting the outcome of the unspecified event was unspecified.									U				UNK	OTH	OTH		Unknown	The pharmacist also reported another case.  See GSK manufacturer A709413A for details.		A0709426A	1						1	Adverse event	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0308377	03/27/2008					U	03/18/2008	This case was reported by a health professional and described the occurrence of influenza in an unspecified number of subjects age and gender who was vaccinated with influenza virus vaccine (manufacturer unspecified). The reporter stated that she had no specifics on these subjects. On an unspecified date the subject received unspecified dose of influenza virus vaccine (unknown). At an unspecified time after vaccination with Influenza virus vaccine, the subject experienced influenza and vaccination failure. At the time of reporting the outcome of the event was unspecified. This case was assessed as medically serious by GSK. The nurse reported that over the years she had seen subjects develop the flu even after receiving the flu vaccine. The nurse reported that over the years she had seen subjects develop the flu even after receiving the flu vaccine but she had no specifics on these subjects nor which vaccine they received.									U				UNK	OTH	OTH	Unknown	Unknown	The nurse reported that over the years she had seen subjects develop the flu even after receiving the flu vaccine but she had no specifics on these subjects nor which vaccine they received. The nurse also reported that 2-3 patients who received Flulaval in the Fall tested positive for influenza A antigen in the last week or two. See GSK number A0711167A for details. She did not have the specific number of subjects or demographics for these subjects but did state they received FluLaval from the same lot number as the subject of case A0711044A who also developed influenza A.		A0711172A	1						1	Influenza; Vaccination failure	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0308380	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline).  Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; Hep B; manufacturer unspecified given on 9 December 2007; Hep A; manufacturer unspecified given on 9 December 2007.  On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste.  The same day, the subject was later vaccination with Fluarix and experienced accidental overdose.  No other adverse events were reported.  In December 2007, the events were resolved.  Outcome of accidental overdose was not specified.  The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose).  Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally.  There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown.  No flu shots were previously received.  It was unknown if the subject had adverse events following receipt of prior immunizations.  It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes.  Forty doses of Fluarix were administered intranasally.  See cases A0699111A, A0699170A-A0699175A, A0699177A - A0699208A for the remaining 39 cases.		A0699176A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~2~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308381	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX, GlaxoSmithKline.  Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant; manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated; manufacturer unspecified given on 9 December 2007.  On 9 December 2007 the subject received unspecified dose of FLUARIX (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste.  The same day, the subject was later vaccinated with FLUARIX and experienced accidental overdose.  No other adverse events were reported.  In December 2007, the events were resolved.  Outcome of accidental overdose was not specified.  The healthcare professional considered the events were probably related to vaccination with FLUARIX (causality not provided for accidental overdose).  Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally.  There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	Unknown	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown.  No flu shots were previously received.  It was unknown if the subject had adverse events following receipt of prior immunizations.  It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of FLUARIX prefilled syringes.  Forty doses of FLUARIX were administered intranasally.  See cases A0699111A, A0699170A-A0699176A, A0699178A-A0699208A for the remaining 39 cases.		A0699177A	1						1	Accidental overdose; Drug administered at inappropriate site; Dysgeusia	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308382	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX, GlaxoSmithKline.  Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant; manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated; manufacturer unspecified given on 9 December 2007.  On 9 December 2007 the subject received unspecified dose of FLUARIX (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste.  The same day, the subject was later vaccinated with FLUARIX and experienced accidental overdose.  No other adverse events were reported.  In December 2007, the events were resolved.  Outcome of accidental overdose was not specified.  The healthcare professional considered the events were probably related to vaccination with FLUARIX (causality not provided for accidental overdose).  Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally.  There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	Unknown	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown.  No flu shots were previously received.  It was unknown if the subject had adverse events following receipt of prior immunizations.  It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of FLUARIX prefilled syringes.  Forty doses of FLUARIX were administered intranasally.  See cases A0699111A, A0699170A-A0699174A, A0699176A-A0699208A for the remaining 39 cases.		A0699175A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration; Wrong drug administered	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308383	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included diphtheria and tetanus and acellular pertussis vaccine ;manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant ;manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated ;manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally. There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown. No flu shots were previously received. It was unknown if the subject had adverse events following receipt of prior immunizations. It was reported the nurses were expecting to administer Flumist, but actually administered a shipment of Fluarix prefilled syringes. Forty doses of Fluarix were administered intranasally. See cases A0699111A, A0699170A-A0699178A, A0699179A - A0699208A for the remaining 39 cases.		A0699179A	1						1	Accidental overdose; Drug administered at inappropriate site; Dysgeusia	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308384	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX, GlaxoSmithKline.  Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant; manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated; manufacturer unspecified given on 9 December 2007.  On 9 December 2007 the subject received unspecified dose of FLUARIX (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste.  The same day, the subject was later vaccinated with FLUARIX and experienced accidental overdose.  No other adverse events were reported.  In December 2007, the events were resolved.  Outcome of accidental overdose was not specified.  The healthcare professional considered the events were probably related to vaccination with FLUARIX (causality not provided for accidental overdose).  Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally.  There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	Unknown	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown.  No flu shots were previously received.  It was unknown if the subject had adverse events following receipt of prior immunizations.  It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of FLUARIX prefilled syringes.  Forty doses of FLUARIX were administered intranasally.  See cases A0699111A, A0699170A-A0699179A, A0699181A-A0699208A for the remaining 39 cases.		A0699180A	1						1	Accidental overdose; Dysgeusia; Wrong drug administered	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308385	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline). Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant; manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated; manufacturer given on 9 December 2007. On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally. There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown. No flu shots were previously received. It was unknown if the subject had adverse events following receipt of prior immunization. It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringe. Forty doses of Fluarix were administered intranasally. See cases A0699111A, A0699170A-A0699180A, A0699182A-A0699208A for the remaining 39 cases.		A0699181A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration; Wrong drug administered	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308386	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX, GlaxoSmithKline. Previous and/or concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis vaccine; manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant; manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated; manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose of FLUARIX (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with FLUARIX and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with FLUARIX (causality not provided for accidental overdose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally. There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown.  No flu shots were previously received.  It was unknown if the subject had adverse events following receipt of prior immunizations.  It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of FLUARIX prefilled syringes.  Forty doses of FLUARIX were administered intranasally.  See cases A0699111A, A0699170A - A0699181A, A0699183A - A0699208A for the remaining 30 cases.		A0699182A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308387	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline). Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant; manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated; manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally. There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown. No flu shots were previously received. It was unknown if the subject had adverse events following receipt of prior immunizations. It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes. Forty doses of Fluarix were administered intranasally. See cases A0699111A, A0699170A-A0699182A, A0699184A-A0699208A for the remaining 39 cases.		A0699183A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration; Wrong drug administered	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308388	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline).  Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; Hep B; manufacturer unspecified given on 9 December 2007; Hep A; manufacturer unspecified given on 9 December 2007.  On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste.  The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose.  No other adverse events were reported.  In December 2007, the events were resolved.  Outcome of accidental overdose was not specified.  The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose).  Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally.  There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown.  No flu shots were previously received.  It was unknown if the subject had adverse events following receipt of prior immunizations.  It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes.  Forty doses of Fluarix were administered intranasally.  See cases A0699111A, A0699170A-A0699183A, A0699185A - A0699208A for the remaining 39 cases.		A0699184A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1|TDAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~TDAP (NO BRAND NAME)~1	USA		Influenza
0308389	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline).  Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; Hep B; manufacturer unspecified given on 9 December 2007; Hep A; manufacturer unspecified given on 9 December 2007.  On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste.  The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose.  No other adverse events were reported.  In December 2007, the events were resolved.  Outcome of accidental overdose was not specified.  The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose).  Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally.  There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown.  No flu shots were previously received.  It was unknown if the subject had adverse events following receipt of prior immunizations.  It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes.  Forty doses of Fluarix were administered intranasally.  See cases A0699111A, A0699170A-A0699184A, A0699186A - A0699208A for the remaining 39 cases.		A0699185A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1|TDAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~TDAP (NO BRAND NAME)~1	USA		Influenza
0308390	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline).  Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; Hep B; manufacturer unspecified given on 9 December 2007; Hep A; manufacturer unspecified given on 9 December 2007.  On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste.  The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose.  No other adverse events were reported.  In December 2007, the events were resolved.  Outcome of accidental overdose was not specified.  The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose).  Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally.  There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown.  No flu shots were previously received.  It was unknown if the subject had adverse events following receipt of prior immunizations.  It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes.  Forty doses of Fluarix were administered intranasally.  See cases A0699111A, A0699170A-A0699185A, A0699187A - A0699208A for the remaining 39 cases.		A0699186A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1|TDAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~TDAP (NO BRAND NAME)~1	USA		Influenza
0308391	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange test in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline). Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant; manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated; manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally. There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown. No flu shots were previously received. It was unknown if the subject had adverse events following receipts of prior immunizations. It was reported the nurse were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes. Forty doses of Fluarix were administered intranasally. See cases A0699111A, A0699170A-A0699186A, A0699188A- A0699208A for the remaining 39 cases.		A0699187a	1						1	Accidental overdose; Dysgeusia; Wrong drug administered	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308392	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline).  Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; Hep B; manufacturer unspecified given on 9 December 2007; Hep A; manufacturer unspecified given on 9 December 2007.  On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste.  The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose.  No other adverse events were reported.  In December 2007, the events were resolved.  Outcome of accidental overdose was not specified.  The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose).  Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally.  There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown.  No flu shots were previously received.  It was unknown if the subject had adverse events following receipt of prior immunizations.  It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes.  Forty doses of Fluarix were administered intranasally.  See cases A0699111A, A0699170A-A0699187A, A0699189A - A0699208A for the remaining 39 cases.		A0699188A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1|TDAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~TDAP (NO BRAND NAME)~1	USA		Influenza
0308393	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline).  Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; Hep B; manufacturer unspecified given on 9 December 2007; Hep A; manufacturer unspecified given on 9 December 2007.  On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste.  The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose.  No other adverse events were reported.  In December 2007, the events were resolved.  Outcome of accidental overdose was not specified.  The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose).  Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally.  There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown.  No flu shots were previously received.  It was unknown if the subject had adverse events following receipt of prior immunizations.  It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes.  Forty doses of Fluarix were administered intranasally.  See cases A0699111A, A0699170A-A0699188A, A0699190A - A0699208A for the remaining 39 cases.		A0699189A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1|TDAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~TDAP (NO BRAND NAME)~1	USA		Influenza
0308395	03/27/2008	SC	65.0	65		F	03/24/2008	My heart rate doubled for 4 days after inj.  My physical therapist checked my pulse and found this to be true.  I had just had knee replacement surgery.  Felt like I was going to have a heart attack.  Have had occasional rapid heart beat.									Y	03/01/2008	03/02/2008	1		PUB	PVT						1						1	Heart rate increased	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~1~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0308397	03/27/2008	NY				F	03/26/2008	Initial redness, swelling and pain around injection site; left deltoid; Now: left arm numbness and pain; diffuse body pain, weakness, and difficulty walking				Y					N	10/30/2007	10/31/2007	1	Elevated ESR	PVT	PVT	Synthroid; Lipitor; Calcium with D; Albuterol	No acute illness	Fibromyalgia, hyperlipidemia, HTN, depression, Vitamin D deficiency			1						1	Asthenia; Gait disturbance; Hypoaesthesia; Injection site erythema; Injection site pain; Injection site swelling; Pain; Pain in extremity; Red blood cell sedimentation rate increased; Chest X-ray; Erythema; Gait disturbance; Hypoaesthesia; Injected limb mobility decreased; Pain; Paraesthesia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TDAP~UNKNOWN MANUFACTURER~~1~IM~LA~TDAP (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U2500AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|TDAP~SANOFI PASTEUR~C2862AA~UNK~IM~LA~TDAP (ADACEL)~2	USA	Emergency room visit	Influenza
0308440	03/27/2008	IL	35.0	35		F	03/27/2008	Pt developed fever to 103 day after vaccine.				Y					Y	03/18/2008	03/19/2008	1	Had blood cx's (-); U/S arm (-)	PVT	PVT		None; pre-splenectomy	Sulfa allergy			1						1	Blood culture negative; Pyrexia; Ultrasound scan normal	FLU3~SANOFI PASTEUR~U2528AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0989U~1~UN~RL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0308451	03/27/2008	KS	27.0	27		F	03/18/2008	This case was reported by a pharmacist and described the occurrence of chest heaviness in a 27-year-old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified). The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject had no prior vaccination with influenza virus vaccine. On 20 November 2007 the subject received 1st dose of Influenza virus vaccine (unknown). On 21 November 2007, 1 day after vaccination with Influenza virus vaccine, the subject experienced chest heaviness, panic attack and feeling of esophagus closing (described as pressure felt on the esophagus). At the time of receipt of influenza virus vaccine, the subject was breast feeding a child who was born in June 2007. No other details regarding the neonate were provided. The subject was seen at a physician's office. At the time of reporting the events were worse.  Follow-up information on 17 December 2007 indicated that the events actually occurred on the same day of vaccination, 20 November 2007. Light headedness was reported as an additional event also beginning the same day of vaccination, 20 November 2007. The events were all resolved and indicated as possibly related to influenza virus vaccine.				Y					U	11/20/2007	11/20/2007	0	UNK	PVT	OTH		Unknown	Please see report A0697555B for details regarding the neonate case. The subject has no history of alcohol use or tobacco use.		A0697555A	1						1	Chest discomfort; Dizziness; Oesophageal stenosis; Panic attack	FLUX~UNKNOWN MANUFACTURER~~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0308452	03/27/2008	NJ	43.0	43		F	03/18/2008	This case was reported by a physician and described the occurrence of hives in a 43-year-old female subject who was vaccinated with Fluarix (GlaxoSmithKline). In early November 2007 the subject received unspecified dose of Fluarix at 0.5 ml. At an unspecified time after vaccination with Fluarix, the subject experienced hives with itching to the point of producing blood. This has occurred three times since receiving Fluarix. In addition, the subject underwent a spirometry test for respirator use and she did not pass. At the time of reporting the events of hives, itching and the abnormal spirometry test were unresolved. The outcome of bleeding skin was not specified. Follow-up received on 25 January 2008 via the physician. Relevant history included an allergy to walnuts. She reported that on 10 November 2007 the subject experienced hives, itching, abnormal spirometry and skin bleeding. The subject was diagnosed with an allergic reaction of unknown etiology. On 05 December 2007, results of a CBC, chemistry screen and sedimentation rate were all normal. On 13 December 2007, all the hives, itching, abnormal spirometry, skin bleeding and the allergic reaction of unknown etiology had improved. The physician considered that the events were not serious and possibly related to the use of Fluarix. A separate summary for the events was provided by the physician which included the following information. 04 December 2007. It was noted that the influenza injection was received and a week or so after that itching which got to the point that the subject would scratch herself to the point of bleeding. Symptoms were noted to include perfuse itching especially at night, no shortness of breath or feeling of throat closing. Subject did not increased nasal congestion and post nasal drip. On 04 December 2007, the subject was without symptoms. Blood work was ordered and subject advised to see physician and an allergies. 05 December 2007: Blood work was performed. CBC with differential, chemistry screen and sedimentation rate were all normal. 06 December 2007: subject seen by another physician. Subject was noted to have had a wheal and flare reaction of upper arm and back without shortness of breath, hypotension or other signs and symptoms of anaphylaxis. Diagnosed with an allergic reaction of unknown etiology. Treated with 40 mg Kenalog intramuscular, Synalar cream 0.025 percent to pruritic areas and Medrol dose pack. Referred to allergist. 22 January 2008: Physician contacted the subject via phone. Subject noted that she feels well. Noted that she does experienced rare episodes of pruritus which she usually can bring on herself by just scratching her skin. Occurs in small areas is of short duration responding almost immediately to the Synalar cream Denies any other symptoms and did not see an allergist.				Y					N	11/01/2007	11/10/2007	9	CBC 05Dec2007 normal; Chemistry normal 05Dec2007 normal; Erythrocyte sedimentation rate 05Dec2007 normal	OTH	PVT		Unknown	Allergy; Allergy to walnuts		A0698420A	1						1	Full blood count normal; Haemorrhage; Hypersensitivity; Laboratory test normal; Pruritus; Red blood cell sedimentation rate normal; Scratch; Spirometry abnormal; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA319AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0308453	03/27/2008	PA	74.0	74		M	03/18/2008	This case was reported by a pharmacist and described the occurrence of pain all over body in a 74-year-old male subject who was vaccinated with Fluarix (GlaxoSmithKline).  No adverse events following previous vaccinations.  On 20 November 2007 at 09:45 the subject received 1st dose of Fluarix (.5 ml, left arm).  In December 2007, approximately 2 weeks after vaccination with Fluarix, the subject experienced pain all over body.  The subject has not required any treatment, but plans to see his physician regarding the all over body pain.  At the time of reporting the event was unresolved.  The pharmacist considered the event was possibly related to vaccination with Fluarix.									N	11/20/2007			UNK	PUB	PUB		Unknown	No adverse events following previous vaccinations indicated on influenza vaccination consent or screening form.		A0698462A	1						1	Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA305BA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0308454	03/27/2008	AL				U	03/18/2008	This case was reported by a pharmacist and described the occurrence of influenza in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline).  On an unspecified date in 2007, the subject received unspecified dose of Fluarix (unknown).  At an unspecified time after vaccination with Fluarix, the subject experienced influenza and lack of efficacy.  The pharmacist did not have all the details regarding the event, but did confirm at least two weeks or more had passed since the administration of Fluarix.  Relevant test results included a quick flu test that diagnosed the subject with the flu.  At the time of reporting the outcome of the events were unspecified.				Y					U				The subject was diagnosed with the flue by a quick flu test in the clinic.	OTH	OTH		Unknown	The subject's medical history was unknown.  It was unknown if the subject previously received flu shots.  The reporting pharmacist inquired of other reports of flu associated with this lot number of Fluarix.  The university's athletic department received Fluarix shots on three different dates.  Two additional cases were reported.  See A0698705A and A0698706A.		A0698694A	1						1	Drug ineffective; Influenza; Laboratory test abnormal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA303AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0308455	03/27/2008	AL				U	03/18/2008	This case was reported by a pharmacist and described the occurrence of influenza in an adult subject of unspecified gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date in 2007, the subject received unspecified dose of Fluarix (unknown). At an unspecified time after vaccination with Fluarix, the subject experienced influenza and lack of efficacy. The pharmacist did not have all the details regarding the event, but did confirm at least two weeks or more had passed since the administration of Fluarix. Relevant test results included a quick flu test that diagnosed the subject with the flu. At the time of reporting the outcome of the events were unspecified.				Y					U				The subject was diagnosed with the flu by a quick flu test in the clinic.	OTH	OTH		Unknown	The subjects history is unknown. It was unknown if the subject previously received flu shots. The reporting pharmacist inquired of other reports of flu associated with this lot number of Fluarix. The University Athletic department received Fluarix shots on three different dates.  Two additional cases were reported. See A069869A and A0698706A.		A0698705A	1						1	Influenza; Influenza serology positive; Vaccination failure	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA303AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0308456	03/27/2008	AL				U	03/18/2008	This case was reported by a pharmacist and described the occurrence of influenza in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline).  On an unspecified date in 2007, the subject received unspecified dose of Fluarix (unknown).  At an unspecified time after vaccination with Fluarix, the subject experienced influenza and lack of efficacy.  The pharmacist did not have all the details regarding the event, but did confirm at least two weeks or more had passed since the administration of Fluarix.  Relevant test results included a quick flu test that diagnosed the subject with the flu.  At the time of reporting the outcome of the events were unspecified.				Y					U				The subject was diagnosed with the flu by a quick flu test in the clinic.	OTH	OTH		Unknown	The subject's medical history was unknown.  It was unknown if the subject previously received flu shots.  The reporting pharmacist inquired of other reports of flu associated with this lot number of Fluarix.  The university's athletic department received Fluarix shots on three different dates.  Two additional cases were reported.  See A0698694A and A0698705A.		A0698706A	1						1	Drug ineffective; Influenza; Laboratory test abnormal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA303AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0308457	03/27/2008					F	03/18/2008	This case was reported by a healthcare professional and described the occurrence of arm tingling in a female subject of unspecified age who was vaccinated with Influenza vaccine (manufacturer unspecified). On an unspecified date the subject received unspecified dose if Influenza vaccine (unknown). At an unspecified time after vaccination with Influenza vaccine, the subject experienced arm tingling that went away 4-5 hours after the vaccine was administered and minor soreness for a couple of days. At the time of reporting the outcome of the events were unspecified.									U				UNK	OTH	OTH		Unknown			A0698837A	1						1	Pain; Paraesthesia	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0308458	03/27/2008	GA	31.0	31		F	03/18/2008	This case was reported by a physician and described the occurrence of generalized rash in a 31-year-old female subject who was vaccinated with Fluarix (GlaxoSmithKline).  On 28 November 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown, right arm).  On 02 December 2007, 4 days after vaccination with Fluarix, the subject experienced generalized rash on multiple body parts.  The subject was treated with steroid injection and topical, as well as Claritin.  At the time of reporting the event was improved.  Follow-up information was received on 11 February 2008 via a physician, who reported that no biopsy was performed on the rash.  At the time of reporting, the event was resolved.  The reporting physician considered the event to be related to vaccination with Fluarix.				Y					Y	11/28/2007	12/03/2007	5	UNK	PUB	PVT		Unknown	The subject had no relevant medical history or concomitant medications.  The subject had not received previous flu shots.  The subject had no adverse events following receipt of prior immunizations.  A total of three patients had experienced adverse events following vaccination with Fluarix.  See A0698850A and A0698853A.		A0698846A	1						1	Rash generalised	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0308485	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX, GlaxoSmithKline.  Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant; manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated; manufacturer unspecified given on 9 December 2007.  On 9 December 2007 the subject received unspecified dose of FLUARIX (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste.  The same day, the subject was later vaccinated with FLUARIX and experienced accidental overdose.  No other adverse events were reported.  In December 2007, the events were resolved.  Outcome of accidental overdose was not specified.  The healthcare professional considered the events were probably related to vaccination with FLUARIX (causality not provided for accidental overdose).  Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally.  There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	Unknown	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown.  No flu shots were previously received.  It was unknown if the subject had adverse events following receipt of prior immunizations.  It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of FLUARIX prefilled syringes.  Forty doses of FLUARIX were administered intranasally.  See cases A0699170A - A0699208A for the remaining 39 cases.		A0699111A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308486	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline). Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant; manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated; manufacturer unspecified given on 9 December 2007. On 09 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally. There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown. No flu shots were previously received. It was unknown if the subject had adverse events following receipt of prior immunizations. It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes. Forty doses of Fluarix were administered intranasally. See cases A0699111A, A0699171A- A0699208A for the remaining 39 cases.		a0699170a	1						1	Accidental overdose; Dysgeusia; Wrong drug administered	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308487	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis vaccine; manufacturer unspecified given on 9 December 2007, hepatitis B vaccine recombinant ; manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated; manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose of FLUARIX (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with FLUARIX and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with FLUARIX (causality not provided for accidental overdose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as FLUMIST and administered intranasally. There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown. No flu shots were previously received. It was unknown if the subject had adverse events following receipt of prior immunizations. It was reported the nurses were expecting to administer FLUMIST, but actually administered a shipment of FLUARIX prefilled syringes. Forty doses of FLUARIX were administered intranasally. See cases A0699111, A0699170A, A0699172A-A0699208A for the remaining 39 cases.		A0699171A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308490	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis vaccine ; manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant ; manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated ;manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose Fluarix (.5 ml, unknown) intranasally (intramuscular administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental over dose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally. There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown. No flu shots were previously received. It was unknown if the subject had adverse events following receipt of prior immunizations. It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes. Forty doses of Fluarix were administered intranasally. See cases A0699111A, A0699170A-A0699189A, A0699191A - A0699208A for the remaining 39 cases.		A0699190A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308491	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX, GlaxoSmithKline.  Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant; manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated; manufacturer unspecified given on 9 December 2007.  On 9 December 2007 the subject received unspecified dose of FLUARIX (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste.  The same day, the subject was later vaccinated with FLUARIX and experienced accidental overdose.  No other adverse events were reported.  In December 2007, the events were resolved.  Outcome of accidental overdose was not specified.  The healthcare professional considered the events were probably related to vaccination with FLUARIX (causality not provided for accidental overdose).  Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally.  There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	Unknown	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown.  No flu shots were previously received.  It was unknown if the subject had adverse events following receipt of prior immunizations.  It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of FLUARIX prefilled syringes.  Forty doses of FLUARIX were administered intranasally.  See cases A0699111A, A0699170A-A0699190A, A0699192A - A0699208A for the remaining 39 cases.		A0699191A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308492	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis vaccine; manufacturer unspecified given on 9 December 2007, hepatitis B vaccine recombinant ; manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated; manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose of FLUARIX (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with FLUARIX and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with FLUARIX (causality not provided for accidental overdose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as FLUMIST and administered intranasally. There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown. No flu shots were previously received. It was unknown if the subject had adverse events following receipt of prior immunizations. It was reported the nurses were expecting to administer FLUMIST, but actually administered a shipment of FLUARIX prefilled syringes. Forty doses of FLUARIX were administered intranasally. See cases A0699111A, A0699170A-A0699191A, A0699193A - A0699208A for the remaining 39 cases.		A0699192A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	DTAP~UNKNOWN MANUFACTURER~~UNK~~~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~~~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1	USA		Influenza
0308493	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX, GlaxoSmithKline.  Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant; manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated; manufacturer unspecified given on 9 December 2007.  On 9 December 2007 the subject received unspecified dose of FLUARIX (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste.  The same day, the subject was later vaccinated with FLUARIX and experienced accidental overdose.  No other adverse events were reported.  In December 2007, the events were resolved.  Outcome of accidental overdose was not specified.  The healthcare professional considered the events were probably related to vaccination with FLUARIX (causality not provided for accidental overdose).  Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally.  There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	Unknown	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown.  No flu shots were previously received.  It was unknown if the subject had adverse events following receipt of prior immunizations.  It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of FLUARIX prefilled syringes.  Forty doses of FLUARIX were administered intranasally.  See cases A0699111A, A0699170A-A0699192A, A0699194A - A0699208A for the remaining 39 cases.		A0699193A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~2~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308494	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis vaccine ; manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant ; manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated ;manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose Fluarix (.5 ml, unknown) intranasally (intramuscular administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental over dose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally. There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown. No flu shots were previously received. It was unknown if the subject had adverse events following receipt of prior immunizations. It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes. Forty doses of Fluarix were administered intranasally. See cases A0699111A, A0699170A-A0699193A, A0699195A - A0699208A for the remaining 39 cases.		A0699194A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~2~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308495	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline).  Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; Hep B; manufacturer unspecified given on 9 December 2007; Hep A; manufacturer unspecified given on 9 December 2007.  On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste.  The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose.  No other adverse events were reported.  In December 2007, the events were resolved.  Outcome of accidental overdose was not specified.  The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose).  Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally.  There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown.  No flu shots were previously received.  It was unknown if the subject had adverse events following receipt of prior immunizations.  It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes.  Forty doses of Fluarix were administered intranasally.  See cases A0699111A, A0699170A-A0699194A, A0699196A - A0699208A for the remaining 39 cases.		A0699195A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~UN~UN~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0308501	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline). Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant; manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally. There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown. No flu shots were previously received. It was unknown if the subject had adverse events following receipt of prior immunizations. It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes. Forty doses of Fluarix were administered intranasally. See cases A0699111A, A0699170A-A0699195A, A0699197A - A0699208A for the remaining 39 cases.		A0699196A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308532	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline).  Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; Hep B; manufacturer unspecified given on 9 December 2007; Hep A; manufacturer unspecified given on 9 December 2007.  On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste.  The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose.  No other adverse events were reported.  In December 2007, the events were resolved.  Outcome of accidental overdose was not specified.  The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose).  Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally.  There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown.  No flu shots were previously received.  It was unknown if the subject had adverse events following receipt of prior immunizations.  It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes.  Forty doses of Fluarix were administered intranasally.  See cases A0699111A, A0699170A-A0699196A, A0699198A - A0699208A for the remaining 39 cases.		A0699197A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~2~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~UN~UN~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0308539	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis vaccine ;manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant ;manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated ;manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose Fluarix (.5 ml, unknown) intranasally (intramuscular administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental over dose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally. There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown. No flu shots were previously received. It was unknown if the subject had adverse events following receipt of prior immunizations. It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes. Forty doses of Fluarix were administered intranasally. See cases A0699111A, A0699170A-A0699197A, A0699199A - A0699208A for the remaining 39 cases.		A0699198A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~2~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308540	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline).  Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; Hep B; manufacturer unspecified given on 9 December 2007; Hep A; manufacturer unspecified given on 9 December 2007.  On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste.  The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose.  No other adverse events were reported.  In December 2007, the events were resolved.  Outcome of accidental overdose was not specified.  The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose).  Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally.  There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown.  No flu shots were previously received.  It was unknown if the subject had adverse events following receipt of prior immunizations.  It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes.  Forty doses of Fluarix were administered intranasally.  See cases A0699111A, A0699170A-A0699198A, A0699200A - A0699208A for the remaining 39 cases.		A0699199A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1|TDAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~TDAP (NO BRAND NAME)~1	USA		Influenza
0308541	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis vaccine ;manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant ;manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated ;manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose Fluarix (.5 ml, unknown) intranasally (intramuscular administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental over dose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally. There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown. No flu shots were previously received. It was unknown if the subject had adverse events following receipt of prior immunizations. It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes. Forty doses of Fluarix were administered intranasally. See cases A0699111A, A0699170A-A0699199A, A0699201A - A0699208A for the remaining 39 cases.		A0699200A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~2~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308542	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis vaccine ;manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant ;manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated ;manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose Fluarix (.5 ml, unknown) intranasally (intramuscular administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental over dose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally. There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown. No flu shots were previously received. It was unknown if the subject had adverse events following receipt of prior immunizations. It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes. Forty doses of Fluarix were administered intranasally. See cases A0699111A, A0699170A-A0699200A, A0699202A - A0699208A for the remaining 39 cases.		A0699201A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~2~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308543	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline).  Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; Hep B; manufacturer unspecified given on 9 December 2007; Hep A; manufacturer unspecified given on 9 December 2007.  On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste.  The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose.  No other adverse events were reported.  In December 2007, the events were resolved.  Outcome of accidental overdose was not specified.  The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose).  Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally.  There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown.  No flu shots were previously received.  It was unknown if the subject had adverse events following receipt of prior immunizations.  It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes.  Forty doses of Fluarix were administered intranasally.  See cases A0699111A, A0699170A-A0699201A, A0699203A - A0699208A for the remaining 39 cases.		A0699202A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1|TDAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~TDAP (NO BRAND NAME)~1	USA		Influenza
0308544	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis vaccine ;manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant ;manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated ;manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose Fluarix (.5 ml, unknown) intranasally (intramuscular administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental over dose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally. There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown. No flu shots were previously received. It was unknown if the subject had adverse events following receipt of prior immunizations. It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes. Forty doses of Fluarix were administered intranasally. See cases A0699111A, A0699170A-A0699202A, A0699204A - A0699208A for the remaining 39 cases.		A0699203A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~2~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308545	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline). Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant; manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated; manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally. There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown. No flu shots were previously received. It was unknown if the subject had adverse events following receipt of prior immunizations. It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes. Forty doses of Fluarix were administered intranasally. See cases A0699111A, A0699170A- A0699203A, A0699205A - A0699208A for the remaining 39 cases.		a0699204a	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration; Wrong drug administered	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~IM~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308546	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis vaccine ;manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant ;manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated ;manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose Fluarix (.5 ml, unknown) intranasally (intramuscular administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental over dose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally. There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown. No flu shots were previously received. It was unknown if the subject had adverse events following receipt of prior immunizations. It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes. Forty doses of Fluarix were administered intranasally. See cases A0699111A, A0699170A - A0699171A, A0699173A - A0699208A for the remaining 39 cases.		A0699172A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~2~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308547	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX, GlaxoSmithKline.  Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant; manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated; manufacturer unspecified given on 9 December 2007.  On 9 December 2007 the subject received unspecified dose of FLUARIX (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste.  The same day, the subject was later vaccinated with FLUARIX and experienced accidental overdose.  No other adverse events were reported.  In December 2007, the events were resolved.  Outcome of accidental overdose was not specified.  The healthcare professional considered the events were probably related to vaccination with FLUARIX (causality not provided for accidental overdose).  Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally.  There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	Unknown	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown.  No flu shots were previously received.  It was unknown if the subject had adverse events following receipt of prior immunizations.  It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of FLUARIX prefilled syringes.  Forty doses of FLUARIX were administered intranasally.  See cases A0699111A, A0699170A-A0699172A, A0699174A - A0699208A for the remaining 39 cases.		A0699173A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~2~ID~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308548	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline).  Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; Hep B; manufacturer unspecified given on 9 December 2007; Hep A; manufacturer unspecified given on 9 December 2007.  On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste.  The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose.  No other adverse events were reported.  In December 2007, the events were resolved.  Outcome of accidental overdose was not specified.  The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose).  Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally.  There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown.  No flu shots were previously received.  It was unknown if the subject had adverse events following receipt of prior immunizations.  It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes.  Forty doses of Fluarix were administered intranasally.  See cases A0699111A, A0699170A-A0699173A, A0699175A - A0699208A for the remaining 39 cases.		A0699174A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1|TDAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~TDAP (NO BRAND NAME)~1	USA		Influenza
0308552	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis vaccine ;manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant ;manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated ;manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose Fluarix (.5 ml, unknown) intranasally (intramuscular administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental over dose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally. There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown. No flu shots were previously received. It was unknown if the subject had adverse events following receipt of prior immunizations. It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes. Forty doses of Fluarix were administered intranasally. See cases A0699111A, A0699170A-A0699204A, A0699206A - A0699208A for the remaining 39 cases.		A0699205A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~2~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308555	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline).  Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; Hep B; manufacturer unspecified given on 9 December 2007; Hep A; manufacturer unspecified given on 9 December 2007.  On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste.  The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose.  No other adverse events were reported.  In December 2007, the events were resolved.  Outcome of accidental overdose was not specified.  The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose).  Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally.  There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown.  No flu shots were previously received.  It was unknown if the subject had adverse events following receipt of prior immunizations.  It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes.  Forty doses of Fluarix were administered intranasally.  See cases A0699111A, A0699170A-A0699205A, A0699207A - A0699208A for the remaining 39 cases.		A0699206A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1|TDAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~TDAP (NO BRAND NAME)~1	USA		Influenza
0308558	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis vaccine ;manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant ;manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated ;manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose Fluarix (.5 ml, unknown) intranasally (intramuscular administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental over dose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally. There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown. No flu shots were previously received. It was unknown if the subject had adverse events following receipt of prior immunizations. It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes. Forty doses of Fluarix were administered intranasally. See cases A0699111A, A0699170A-A0699206A, and A0699208A for the remaining 39 cases.		A0699207A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~2~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308560	03/27/2008	CA				U	03/18/2008	This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline). Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant ; manufacturer unspecified given on 9 December 2007; hepatitis A inactivated ; manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as Flumist and administered intranasally. There were no other adverse events other than bad taste.									Y	12/09/2007	12/09/2007	0	UNK	MIL	MIL		Unknown	Relevant medical history and concurrent medications were unknown. No flu shots were previously received. It was unknown if the subject had adverse events following receipt of prior immunizations. It was reported the nurses were expecting to administer FluMist, but actually administered a shipment of Fluarix prefilled syringes. Forty doses of Fluarix were administered intranasally. See cases A0699111A, A0699170A - A0699207A for the remaining 39 cases.		A0699208A	1						1	Accidental overdose; Dysgeusia; Incorrect route of drug administration; Wrong drug administered	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3168A~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0308561	03/27/2008		65.0	65		F	03/18/2008	This case was reported by a physician and described the occurrence of hives in an approximately 66 year old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 2 November 2007 the subject received unspecified dose of Fluarix (unknown). At an unspecified time after vaccination with Fluarix, the subject experienced hives. At the time of reporting the outcome of the event was unspecified.									U	11/02/2007			UNK	OTH	OTH		Unknown			A0699816A	1						1	Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLA035AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0308562	03/27/2008	CA	13.0	13		F	03/18/2008	This case was reported by a pharmacist and described the occurrence of injection site redness in a 13-year-old female subject who was vaccinated with Fluarix (GlaxoSmithKline).  No concurrent medications.  On 7 December 2007 at 15:00 the subject received 1st dose of Fluarix (unknown, left arm).  Immediately after vaccination with Fluarix, the subject experienced injection site soreness and within hours experienced injection site redness and heat at injection site.  The subject also experienced vaccination error.  At the time of reporting the outcome of the redness at the injection site and heat at the injection site was resolved.  Soreness at the injection site was unresolved.									N	12/07/2007	12/07/2007	0	UNK	PUB	PUB		Unknown	Adverse events following previous vaccinations with hepatitis and meningitis vaccine caused a fever of 101.		A0700189A	1						1	Immediate post-injection reaction; Injection site erythema; Injection site pain; Injection site warmth; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA305AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0308563	03/27/2008	TX	59.0	59		F	03/18/2008	This case was reported by a consumer and described the occurrence of ear pain in a 59-year-old female subject who was vaccinated with Influenza vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included codeine allergy, penicillin allergy and sulfa allergy. On 8 October 2007 at 08:15 the subject received unspecified dose of Influenza vaccine (.5 ml, unknown, left arm) that has expired in the summer of 2007 (expired vaccine used). On 22 October 2007, 14 days after vaccination with Influenza vaccine, the subject experienced ear pain, throat pain, and was sick. The subject was treated with Levaquin for her sickness and it took a week for her to recover. At the time of reporting the events were resolved.				Y					Y	10/08/2007	10/08/2007	0	UNK	PUB	PVT		CODEINE ALLERGY, PENICILLIN ALLERGY, SULFA ALLERGY	The subject does not include caffeine, alcohol or raspberries in her diet. The subject has previously received flu shots without experiencing adverse events. No adverse events were reported following receipt of prior immunizations. The subject was notified by the clinic that 15 batches of expired vaccine were sent in error to the clinic. The subject was requested to return to in order to receive a non-expired vaccine.		A0700338A	1						1	Ear pain; Expired drug administered; Malaise; Pharyngolaryngeal pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0308564	03/27/2008					U	03/18/2008	This case was reported by a consumer and described the occurrence of dizziness in an unknown number of subjects of unspecified ages and gender who were vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. In 2007, the subjects received unspecified doses of Influenza vaccine (unknown). The reporter stated he talked with numerous people who have experienced dizziness, inner ear problems, nausea and vomiting after receiving the flu shot this year. At the time of reporting the outcome of the events were unspecified.									U				UNK	OTH	OTH		Unknown	Three additional cases of dizziness, inner ear problems, nausea and vomiting after receiving the flu shot this year were reported. See A0700786A, A0700787A, and A0700788A. The reporter's original case on himself was A0693073A.		A0700781A	1						1	Dizziness; Inner ear disorder; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0308565	03/27/2008		40.0			M	03/18/2008	This case was reported by a consumer and described the occurrence of dizziness in an male subject aged between 40 and 49 years old who was vaccinated with Influenza vaccine, manufacturer unspecified). A physician or other health care professional has not verified this report. In 2007, the subject received an unspecified dose of Influenza vaccine (unknown). The reporter stated he a farmer in his 40s experienced dizziness, inner ear problems, nausea and vomiting after receiving the flu shot this year. At the time of reporting the outcome of the events were unspecified. This case was assessed as medically serious by manufacturer. At the time of reporting the events were resolved.									Y				UNK	OTH	OTH		Unknown			a0700823a	1						1	Dizziness; Inner ear disorder; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0308566	03/27/2008					U	03/18/2008	This case was reported by nurse, via consumer and described the occurrence of dizziness in an unknown number of subjects of unspecified ages and gender who were vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. In 2007, the subjects received unspecified doses of Influenza vaccine (unknown). The reporter stated he talked with a nurse who stated she had patients who experienced dizziness, inner ear problems, nausea and vomiting after receiving the flu shot this year. At the time of reporting the outcome of the events were unspecified.									U				UNK	OTH	OTH		Unknown	Three additional cases dizziness, inner ear problems, nausea and vomiting after receiving the flu shot this year were reported. See A0700781A, A0700786A, and A0700788A. The reporter's original case on himself was A0693073A.		A0700787A	1						1	Dizziness; Inner ear disorder; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0308567	03/27/2008					U	03/18/2008	This case was reported by a consumer, via his father and described the occurrence of dizziness in an unknown number of subjects of  unspecified ages and gender who were vaccinated with Influenza vaccine, manufacturer unspecified. A physician or other health care professional has not verified this report. In 2007, the subjects received unspecified doses of Influenza vaccine (unknown0. The reporter stated his son has known individuals who have experienced dizziness, inner ear problems, nausea and vomiting after receiving the flu shot this year. At the time of reporting the outcome of the events were unspecified.									U	01/01/2007	01/01/2007	0	UNK	OTH	OTH		Unknown	Three additional cases of dizziness, inner ear problems, nausea and vomiting after receiving the flu shot this year were reported. See A0700781A, A0700786A, and A070087A. The reporter's original case on himself was A0693073A.		A07000788A	1						1	Dizziness; Inner ear disorder; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0308569	03/27/2008					F	03/18/2008	This case was reported by a consumer, via manufacturer and described the occurrence of pain in arm post vaccination in a female subject of unspecified age who was vaccinated with Influenza vaccine, manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Influenza vaccine (unknown). At an unspecified time after vaccination with Influenza vaccine, the subject experienced pain in arm post vaccination. The subject reported when she receives her yearly flu vaccine (manufacturer unknown) her arm hurts. No other information was provided.									U				UNK	OTH	OTH		Unknown			A0700824A	1						1	Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0308570	03/27/2008					F	03/18/2008	This case was reported by a consumer and described the occurrence of influenza in a female subject of unspecified age who was vaccinated with influenza virus vaccine (Influenza vaccine (unspecified), manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date, the subject received an unspecified dose of Influenza vaccine (manufacturer unspecified). At an unspecified time after vaccination with an Influenza vaccine, the subject experienced influenza, vaccination failure and allergic to flu shots. Per the source document: Patient can't get the flu shot (manufacturer unknown) because they are allergic. When they have received the flu shot they have gotten the flu. No further information was provided. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was unspecified.									U				UNK	OTH	OTH		Unknown	The subject had a history of allergies to influenza vaccines. The subject reported contracting influenza following previous influenza vaccination(s).		A0701032A	1						1	Influenza; Similar reaction on previous exposure to drug; Vaccination failure	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0308571	03/27/2008	MA				M	03/18/2008	This case was reported by a pharmacist and described the occurrence of extensive swelling of vaccinated limb in a male subject aged between 50 and 59 years old who was vaccinated with FLUARIX (GlaxoSmithKline) . It was noted that the subject was very heavy. On 24 December 2007 the subject received unspecified dose of FLUARIX (.5 ml prefilled syringe) in his left leg. It was reported that an intramuscular needle was not used and the vaccine may have been administered subcutaneously. On 25 December 2007, 1 day after vaccination with FLUARIX, the subject experienced extensive swelling of vaccinated limb and skin discoloration at injection site. The reporter stated that the subject had a severe site reaction that was 8 x 10 in size, purple and swollen. At the time of reporting the outcome of the events were unspecified.									U	12/24/2007	12/24/2007	0	UNK	PVT	OTH		Unknown	Overweight		A0701045A	1						1	Injection site discolouration; Injection site swelling; Wrong technique in drug usage process	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~SC~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0308472	03/28/2008	GA	0.53	0	.5	F	03/25/2008	3 days splotchy red dot rash appeared on extremities only, none on face that went away with BENADRYL.									Y	12/17/2007			None	PVT	PVT	None	None	None			1						1	Erythema; Rash; Rash macular	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B125CA~2~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2481CA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B54014D~2~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0903U~UNK~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0308533	03/30/2008	GA	0.75	0	.8	M	03/30/2008	The patient developed autism symptoms from absolutely healthy. He was diagnosed moderate autism on 03/28/2008.  9/5/08 Reviewed PCP office records of 2/6/06-8/2/07. FINAL DX: none provided Records reveal patient experienced excellent health in 2006.  RTC 1/07 w/pharyngitis, 3/20/07 w/URI & 4/07 w/pharyngitis & OM.  May, 2007 parent expressed concern re development.  8/07 noted to have atopic dermatitis.  9/16/08 Received psychological report from parent for 3/28/2008. FINAL DX:Autism spectrum disorder Records reveal patient experienced communication, play, motor/sensory & socialization delays as well as stereotyped behaviors.			Y						N	11/04/2006	12/01/2006	27		UNK	UNK			Flu shot #2, 12/5/06, lot # U2307AA, LL  PMH: NSVD, apgars 8/9, breast fed.	none~ ()~~0.00~Patient		1						1		FLU3~SANOFI PASTEUR~U2247AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0308585	03/31/2008	AR	56.0	56		F	03/25/2008	Constant tingling of hands and feet, sometimes back of head.  Back is very tired at end of day.  Around nose, mouth, and both lower arms as well as upper right arm, across shoulders. 4/3/08-records received-Seen on 1/17/08- for C/O tingles all over, constant tingling of hands and feet and sometimes back of head, around nose, mouth and both lower arms as well as upper right arm. Back pain was due to cholelithiasis and a cholecystectomy was performed on 11/30/07 with improvement of back pain and to some degree the tingling. Dizzy sensation. Vision is slightly worse.									N	11/08/2007	11/12/2007	4	4/3/08-records received-Immunoglobulin G low at 491, Lyme titer negative. MRI scan of cervical spine-Impression-component of central spinal stenosis and cord flattening at a few cervical levels as described above related to mild degenerative changes, bulging of the disc and a slightly small spinal canal congenitally. Tiny associated disc protrusions are present at C3-4 and C5-6 and there is a component of neural foraminal encroachment on left at C4-5. Pineal cyst. Nerve conduction studies 2/22/08-Impression:abnormalities are restricted to right median nerve. Findings are consistent with carpal tunnel syndrome. A small fiber neuropathy may exist without changes on routine nerve conduction studies.	PUB	UNK			Hydromorphene; HCL 4/3/08-records received-PMH: high blood pressure and tension type headaches. cholelithiasis and a cholecystectomy was performed on 11/30/07		AR0815	1						1	Fatigue; Paraesthesia	FLU3~SANOFI PASTEUR~U2514AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0308619	03/31/2008	MD	11.0	11		M	03/11/2008	Vomiting, fever, lethargy - cough, fever, 103-104 for 2 1/2 more weeks - ear infection (amoxicillin) - pneumonia - (Zithromax) anorexia - lost 14 pds. Seizures, A.D.E.M - acute disseminated encephalomyelitis. 5 days pulse Prednisone, I.C.U. E.B.V. and MRA's. 4/14/08-records received for DOS 2/7-2/19/08-DC DX: Presume acute demyelinating encephalomyelitis. Treated with azithromycin and on day four developed mask-like facies, tremors, rigidity, sweating and facial flushing. On 2/7/08-change in mental status. Intensive care. Treated with high dose decadron. Decreased gag relfex, increased tremors and sweats. Autonomic storms. NG tube placement. Anxiety. 1/21/2010 Emotional, psychological diagnosis of brain injury that has resulted in ADHD, learning disabilities, special accommodations at school and home, asthma, balance problems, still received occupation therapy, is on medication related to sustained injury and continues in therapy with a psychiatrist. Also qualifies for D.D.A.  My son also suffers from P.T.S.D. Follow-up: Now diagnosed with Asthma. Also, emotional problems, ie., anxiety, depression, post traumatic stress syndrome, headaches, lightheadedness, endurance issues and generalized fatigue. Yes, patient educational is suffering with memory problems and we are in the process of Neuropsy and Neuroeducational testing to measure potential permanent damage due to encephalomyelopathy.			Y	Y	Y	12	Y	Y	N	12/04/2007	12/24/2007	20	Lumbar Puncture , 2 MRIs, Blood work, Mitochondrial, + Metabolic 4/14/08-records received-MRI and MRA showed edema of the putamen and caudate regions. Repeat MRI showed increased uptake in globus pallidus and continued swelling of caudate and putamen. CSF gram stain negative. Acetyl C2 high. P-serine low.	PVT	PVT	None	No 4/14/08-records received-Twenty four days prior to admission developed fever to 103-104, sore throat, headache and some lethargy. Diagnosed with otitis media. After treatment developed migraine headaches, cough and diagnosed with pneumonia.	Aortic Quadricuspid 4/14/08-records received-PMH: 26 week preemie, having bronchopulmonary dysplasia (BPD), necrotizing entercolitis (NEC), gastroesophageal reflux disease (GERD), surgical repair of inguinal hernia and tonsillectomy/adenoidectomy, quadricuspid aortic valve.	Tachycardia; flushing, crying, irritability~Rotavirus (no brand name)~3~1.00~Sibling		1						1	Anorexia; Asthma; Attention deficit/hyperactivity disorder; Autonomic nervous system imbalance; Balance disorder; Blood test; Brain injury; Convulsion; Cough; Dizziness; Epstein-Barr virus test; Fatigue; Flushing; Headache; Learning disability; Lethargy; Leukoencephalomyelitis; Lumbar puncture; Mental status changes; Metabolic function test; Nuclear magnetic resonance imaging; Post-traumatic stress disorder; Pyrexia; Vomiting; Weight decreased	FLUN3~MEDIMMUNE VACCINES, INC.~500482P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0308620	03/31/2008	PA	54.0	54		M	03/27/2008	Patient had influenza vaccine on 10-18-07. Complaints on 1/9/08 of numbness for 1-2 wks in arms/feet. 2/22/08 unable to ambulate. 3/2 Placed on vent. (1/21/08 had malignant lymphoma removed from tonsil). MD diagnosis Guillain barre, 2 lymphoma.  6/24/08 Death certificate states COD as respiratory failure with Guillain-Barre Syndrome & lymphoma. as underlying cause.    6/13/08 Reviewed hospital medical records for 2/23-5/16/2008. FINAL DX: diffuse large B cell lymphoma Records reveal patient experienced paresthesias of hands/feet, sore throat.  Had lump on tonsils removed & found to have diffuse large B cell lymphoma.  Weakness & paresthesias worsened & dx w/GBS.  Had very prolonged extensive hospital course complicated by multiple issues: chronic ventilator dependent respiratory failure; tracheostomy; PEG feeding tube; multiple septic episodes; pulmonary embolism; chemotherapy.  Condition worsened, developoed MRSA septicemia, became unresponsive.  Family requested comfort measures only, patient was extubated & expired 5/16/2008.  Patient had cancer and was undergoing chemo and radiation. This was cause of death.	Y	05/16/2008	Y	Y	Y	30	Y		N	10/18/2007	12/01/2007	44	CSF - 153 protein on 2/25/08	PVT	OTH	Unknown	Unknown	Unknown			1						1	Abasia; CSF protein increased; Guillain-Barre syndrome; Hypoaesthesia; Lymphoma; Mechanical ventilation	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFUA05288~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Results in Death	Influenza
0308661	04/01/2008		7.0	7		M	04/01/2008	We received on 12 FEB 2008 from a healthcare professional the following information: A 7-year-old male patient, born on 21 JUN 2000 was vaccinated with FLUVIRIN (batch no. unknown) on 19 NOV 2007. The patient was killed in an automobile traffic accident on 01 FEB 2008. The subject had participated in a clinical trial sponsored by MedImmune. FLUVIRIN was used in that trial as a control, and Novartis Vaccine & Diagnostics (NVD) has donated the FLUVIRIN, but other than that has not been involved. Although the event did not occur during the duration of the trial, and the investigator did not see any causal relationship to the vaccination with FLUVIRIN, he reported the event to the IRB and NVD because the child had died.	Y	02/01/2008							N	11/19/2007	02/01/2008	74		OTH	OTH	No other medications	Unknown			MA20080504	1						1	Death; Road traffic accident	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0308665	04/01/2008		5.0	5		M	04/01/2008	On 19 MAR 2008 we received via a physician the following information: A 5-year-old male child with known asthma (subject 1-07-06206), born on 22 FEB 2002, was vaccinated i.m. into the deltoid with Fluvirin (batch no. 80686) on 20 NOV 2007.  He presented on 20 DEC 2007 with fever, abdominal pain and wheezing.  He responded to bronchodilators and was admitted to hospital for rehydration and treatment of pneumonia (i.v.antibiotics).  The patient was discharged improved on 21 DEC 2007.  The subject participated in a field trial.  Fluvirin was used in that trial as a control, and Novartis Vaccine & Diagnostics (NVD) has donated the Fluvirin, but other than that has not been involved.  The investigator did not see any causal relationship with the vaccination and Fluvirin.  Concomitant medication included Flonase and albuterol.  Seriousness criterion: hospitalisation.  Causality: not related, due to improbable time interval.  Pneumonia was most likely caused by bacterial infection as the patient improved under antibiotics.  Expectedness assessment according to EU SPC/US label: The reported symptoms are not expected after vaccination with Fluvirin.  No change in benefit-risk ratio.  No measures necessary.					Y	1			N	11/20/2007	12/20/2007	30		OTH	OTH	ALBUTEROL, FLONASE	ASTHMA			MA20080505	1						1	Abdominal pain; Pneumonia; Pyrexia; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80685~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0308678	04/01/2008	NM	0.8	0	.8	M	03/24/2008	3/19/08 - T.C. Mother, pt did not show to appt for booster. Mother reported pt developed rash all over body on the day of the administration (2/18/08), that is why she didn't bring the pt. Mother applied aloe vera gel and rash dried up. Pt stable at this time.									Y	02/18/2008	02/18/2008	0		PUB	PUB		Erythema to (R) eyelid	None			1						1	Rash generalised	FLU3~SANOFI PASTEUR~UT2475BA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0308679	04/01/2008	ID				U	12/10/2007	Had flu mist x 9 days ago.  Was seen in UCC on 09 Dec with HA, no temperature, sore throat, any + post nasal drip.  Given Atarak + qtr 2 yo.				Y						11/30/2007				MIL	UNK						1						1	Headache; Pharyngolaryngeal pain; Postnasal drip	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0308680	04/01/2008	ID				U		Patient seen 12/5/07 for complaints of nausea, body aches.  Received flu mist x 6 days ago (per patient) given 24 hours gtrs.									Y	12/03/2007				MIL	UNK						1						1	Nausea; Pain	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0308682	04/01/2008	AZ	71.0	71		M	12/21/2007	Right upper lateral arm with erythema and induration.									U	12/18/2007	12/18/2007	0	None	PVT	UNK	ASA; Lisinopril; Metformin; Simvastatin; Benadryl	None	NKDA; Benign essential hypertension; Hyperlipidemia; Type II Diabetes; Lower leg swelling			1						1	Erythema; Induration	FLU3~SANOFI PASTEUR~U2453AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1416U~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0308772	04/02/2008	MN	4.0	4		M	04/02/2008	The day after, patient ran a 104F plus fever. His throat hurt, arms and legs hurt. This went on for 3 1/2 days.  This is the 3rd year he has gotten sick after the flu shot.  This can not be a coincidence.  No one else in the family catches this from him.  He is the only one who ends up sick.  He now seems to have reoccurring symptons every 6 weeks.  We administer Tylenol and Motrin.  That seems to keep the fever in track and I use a wet cold rag on his forehead.				Y					Y	10/17/2007	10/18/2007	1		UNK	UNK	none that I remember	none to our knowledge	penicillin	very high temp,sore throat, body ache~Influenza (Seasonal) (no brand name)~1~1.90~Patient		1						1	Pain in extremity; Pharyngolaryngeal pain; Pyrexia; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U2502AA~5~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0308779	04/02/2008	VA	1.0	1	.0	M	04/02/2008	Mother states child was seen for well baby visit on November 14, 2007, during visit, child received six shots.  Following visit, mother and child returned home; around 4:00 PM, the child began shaking bad.  Mother indicated she had never saw him like that.  An ambulance was called and transported the child to ER.  The temperature in the emergency was 104; mother states ER physician explained this was normal.  Child was monitored in ER for three hours, given Tylenol, no other diagnosis.  Following three hours, child was discharged from ER. Mother purchased Tylenol and Motrin, returned home and alternated medication at home.  Following this, mother and child went to visit child's grandmother.  Child was fine rest of the evening, then around midnight the shaking symptoms returned. States he was shaking all over, eyes were white, fingers purple, foam around mouth.  Ambulance was called and transported to emergency room.  Temperature in ER was 104.  Mother related to ER staff the temp. may be related to the immunizations.  She states ER staff asked why so many vaccines were given?  Blood work and urine tests were obtained.  ER staff related to mother the tests were OK and the temp. may have been caused by the immunizations.  Child again released from ER.  Family returned to home; mother continued to administer Tylenol and Motrin every 4-6 hours as ER had instructed.  Mother states, after episode, child was fine and playing.  On January 27, 2008 mother and child were in the park.  While there, the child laid down and presented the same symptoms of eyes white, fingers purple, foam around mouth.  Temperature was 104, ambulance called, transported to ER; blood, urine tests, and x-ray were performed.  Child was admitted to the hospital from 1-27 to 2-3-08, diagnosis of flu.  Mother has since transferred care to PMD.  On March 5, 2008, child had same symptoms.  Mother states, she called the physician who instructed her to bring the child into the office.  When child was seen by PMD on March 5, diagnosis of ear infection was given.  Child's mother and grandmother concerned over repeated episodes, and have discussed concerns with child's physician.  States child has had no further episodes.  5/13/08 Reviewed hospital medical records of 1/31-2/3/08, ER records of 11/14/2007 & 3/4/2008. FINAL ER DX of 11/14/2007: febrile seizure s/p immunizations. 11/14/2007 ER records reveal patient experienced seizure activity at home, none while in ER.  Tx w/fluids & antipyretics & d/c to home   1/31-2/3/2008 hospitalization FINAL DX: febrile seizure; viral syndrome influenza A (+) w/fever & URI. Patient experienced shaking of UEs, rolling up of eyes lasting for approx 5 min.  Developed nasal congestion on day of admission.  Tx w/IV fluids & antipyretics.  Responded well & afebrile on d/c to home.   3/4/2008 ER records reveal patient experienced fever, shaking chills, wheezing.  FINAL ER DX: viral illness & fever				Y					Y	11/14/2007	11/14/2007	0	No tests performed during first ER visit.  Family state blood and urine tests were performed during second ER visit.  Hospital LABS: CXR WNL.  Influenza A antigen (+).  RSD (-).  Blood & urine c/s neg.  Segs 46% (H), lymphs 42% (L), monos 10% (H).   Chemistry  & UA WNL.  3/4/08 ER LABS: CXR WNL.  Urine & blood c/s neg.	UNK	UNK	None	None	None			1						1	Blood test normal; Body temperature increased; Cyanosis; Ear infection; Foaming at mouth; Gaze palsy; Influenza; Tremor; Urine analysis normal; X-ray	DTAP~SANOFI PASTEUR~C2628AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2459KA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB175AA~1~IM~LL~HEP A (HAVRIX)~1|HIBV~SANOFI PASTEUR~UF196AB~4~IM~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0412U~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PPV~PFIZER\WYETH~B08700H~4~IM~RL~PNEUMO (PNU-IMUNE)~1|VARCEL~MERCK & CO. INC.~1471U~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0308799	04/02/2008	TX	10.0	10		M	03/28/2008	Large area of warm erythema over tricep area R arm.									Y	03/25/2008	03/26/2008	1		OTH	OTH	Advair Disk 100/50, Singulair 5 mg, Nasonex, albuterol MDS	None	Asthma			1						1	Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U2487AA~3~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0719U~2~UN~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0268473	04/03/2008	MA	77.0	77		F	12/07/2006	Rt. upper arm from elbow to 3 inches below shoulder, redness and swelling was noted, this wrapped around the arm.  The reddened area was warm and painful to touch.  She was unable to raise her arm.  This lasted from 11/30/06 at 6:00 PM until 12/4/06.  She iced the area frequently and the symptoms gradually subsided.									Y	11/30/2006	11/30/2006	0	None	PUB	PUB	Fosamax, Celexa, HCT, Lipitor, Monopril, Synthroid, prednisone 1 mg d/y, atenolol	None	High B/P, high cholesterol, low thyroid, arthritis, osteoporosis			1						2	Injected limb mobility decreased; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2279AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0577R~1~UN~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0308816	04/03/2008	SC	61.0	61		F	03/30/2008	Injection given in AM 8/8/07.  By 4 PM same day temperature was 104, area was hot, edematous and red.  Pronounced pain at site.  By next AM edema had spread to hand, redness was circumstantial and extended from hand to neck.  Skin on that arm eventually peeled.				Y					Y	08/08/2007	08/08/2007	0	None	PVT	OTH	Topnol XL; Allegra; Omeprazole	None	Bacitracine Opth Oint; Ranilidine; Desipramine			1						1	Body temperature increased; Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth; Skin exfoliation	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~0740U~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0308848	04/03/2008	NY	3.0			F	04/03/2008	Patient developed a noticable stutter in speech following the flu shot that was not present before the shot.  She also seems unable to form sentences properly and frequently uses jumbled words.  She is unable to comprehend shapes, colors, letters or numbers.  Again, this was not the case prior to the flu shot. It should also be noted that patient had eczema as an infant that was related to food intolerances.  This cleared up with a proper diet.  However the eczema returned on the back of her arms and on her torso following the flu vaccine and will not clear up.  It has also been determined that she is intolerant to artificial food coloring which only developed after the flu vaccine.													Patient is going to be evaluated.	UNK	UNK	none	none	Gluten, soy, dairy food intolerance			1						1	Dysphemia; Eczema; Learning disorder; Reaction to food additive; Speech disorder	FLU3~SANOFI PASTEUR~U24528AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0308930	04/04/2008	WA	13.0	13		F	03/31/2008	Firm subcutaneous swelling, 1 cm. >one month after immunization				Y					U	02/19/2008	03/26/2008	36	None	PVT	PVT	None	None	None			1						1	Swelling	FLUN3~MEDIMMUNE VACCINES, INC.~~1~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~~3~UN~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0308932	04/04/2008	NY	70.0	70		F	03/31/2008	Pain in arm of vaccine lasting months-has occurred in 07 and 06.									N	11/19/2007	11/19/2007	0	None	PVT	PVT	ADVIL, VITAMIN, TYLENOL CA	None	Goiter s/p thyroidectomy; menopause; hypercholesterolemia; osteopenia	sore arm~Influenza (Seasonal) (no brand name)~UN~69.00~In Patient		1						1	Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA05~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0308966	04/04/2008	FL	4.0	4		F	04/04/2008	Hep A # 2 was given prior to recommended 6 mos interval for booster. The patient is stable. The mother is aware of incorrect administration.									Y	04/03/2008			None	PVT	PUB		Seen 04/01/08: None except resolved abdominal pain	Hx of Grade II Vesicoureteral Reflux of both kidneys.			1						1	Inappropriate schedule of drug administration	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B054AA~5~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2444AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0872~5~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1410F~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1657U~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0308956	04/06/2008	MN	71.0	71		F	04/06/2008	Severe pain in arm, swelling and severe redness from shoulder to elbow, hot to the touch.  Fever, flu-like symptoms (aches), and trouble breathing.  This lasted for over 24 hours.  Slept a good portion of the next day.									Y	04/04/2008	04/04/2008	0		UNK	UNK						1						1	Dyspnoea; Erythema; Hypersomnia; Influenza like illness; Oedema peripheral; Pain in extremity; Pyrexia; Skin warm	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0308963	04/06/2008	TX	25.0	25		M	04/06/2008	12:45 Received Hep B, Hep. A and Flu vaccine. Returned to immunization area approx. 1 1/2 - 2 hours later c/o SOB, coughing, chest tightness. States feeling ill x 2 days, was not able to sleep last night due to coughing. B/P 126/78, P 100, R 22, T 97.8.									U	04/06/2008	04/06/2008	0		MIL	UNK	None	C/O Cough and cold x 2 days.	None			1						1	Chest discomfort; Cough; Dyspnoea; Malaise; Sleep disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA312BA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB525BA~2~UN~RA~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB224BA~2~UN~LA~HEP A (HAVRIX)~1	USA		Influenza
0309028	04/07/2008	MO	0.53	0	.5	F	04/07/2008	Pt was given Pediarix #3, Prevnar #3 and Rotavirus #3 on 2-11-08. Parent states the child got a high fever and had a siezure.  The parent took the child to Hospital.									Y	02/11/2008	02/12/2008	1	FLu A&B antigen, RSV test, UA result available at Hospital	UNK	UNK						1						1	Convulsion; Influenza serology; Pyrexia; Respiratory syncytial virus serology; Urine analysis	6VAX-F~UNKNOWN MANUFACTURER~AC21B137BA~4~IM~RL~DTAP+IPV+HEPB+HIB (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~UT2477FA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B70145D~4~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1701U~4~IM~LL~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0302116	04/08/2008	UT	15.0	15		F	04/07/2008	Information has been received from the mother concerning her 16 year old daughter with no pertinent medical history and no history of drug reactions/allergies who in November 2007, was vaccinated with a first dose of GARDASIL.  There was no concomitant medications reported.  Toward the end of November 2007, the patient developed symptoms.  On 01-DEC-2007, about 20 days after receiving the first dose of GARDASIL, the patient was hospitalized because her thighs were numb and was diagnosed with Guillian Barre Syndrome.  She was transferred to another hospital.  The patient was in the hospital for about 3 or 4 days and was released because she had feeling back in her legs.  On an unspecified date, the patient was hospitalized a second time because she hyperventilates, had seizures, and was fainting.  The patient had heart tests and neurological tests performed.  It has been 5 months since she received the first dose of GARDASIL and is still passing out, getting dizzy, having seizures, and also gets blisters on the roof of her mouth.  At the time of reporting, the patient had not recovered.  The patient's sister also experienced an adverse event after receiving a first dose of GARDASIL reported in WAES # 0804USA01228.  Additional information has been requested.				Y	Y				N	11/01/2007	11/01/2007	0	Neurological; Diagnostic Laboratory	OTH	OTH	Unknown		Unknown		WAES0803USA05046	1						2	Blood test normal; Convulsion; Corrective lens user; Decreased appetite; Diplegia; Dizziness; Fatigue; Fatigue; Headache; Hypersomnia; Hypophagia; Loss of consciousness; Nuclear magnetic resonance imaging normal; Oral mucosal blistering; Sensation of heaviness; Weight decreased; Convulsion; Dizziness; Guillain-Barre syndrome; Hyperventilation; Hypoaesthesia; Laboratory test; Loss of consciousness; Neurological examination; Oropharyngeal blistering; Syncope; Abasia; Blood test; Fatigue; Guillain-Barre syndrome; Hypoaesthesia; Laboratory test; Loss of consciousness; Malaise; Nuclear magnetic resonance imaging; Paralysis; Stress	FLUX~UNKNOWN MANUFACTURER~~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~1426F~1~UN~LA~HPV (GARDASIL)~1|HPV4~MERCK & CO. INC.~~1~UN~UN~HPV (GARDASIL)~2|HPV4~MERCK & CO. INC.~~UNK~UN~UN~HPV (GARDASIL)~3	USA	Hospitalisation	Influenza
0309111	04/08/2008	CA	48.0	48		F	04/03/2008	Guillain Barre 4/18/08-records received for DOS 11/25-12/07/07- DC DX: Chronic inflammatory demyelinating polyradioneuropathy. Admitted with progressive upper and lower extremity numbness and weakness. Sensory symptoms started about several months ago with burning in her feet. One week duration of numbness with increasing numbness throughout her body and weakness as well in legs. Ten days prior unable to go up or down stairs.  IVIG and Plasmapheresis. PE: absent DTRs. Gait ataxia. Walker use at discharge. Discharged to rehabilitation facility.			Y	Y	Y	12			N	11/07/2007	11/15/2007	8	Spinal tap; nerve induction 4/18/08-records received-MRI cervical and thoracic spine negative. Electrodiagnostic studies diagnosed chronic inflammatory demyelinating polyradiculopathy. C reactive protein increased 1.6. ANA negative. Rheumatoid factor positive. AST and ALT elevated.	OTH	PVT		None	None 4/18/08-records received-Two weeks prior received Flu shot. Began Mirapex for restless legs syndrome and antibiotic for UTI. PMH: fatty liver.			1						1	Lumbar puncture	FLU3~SANOFI PASTEUR~U25122AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0309115	04/08/2008	IL	70.0	70		F	03/21/2008	About 36 hrs post flu vaccine, pt developed heart symptoms & went to local hospital.  Dx: atrial flutter/fibrillation & ventricular tachycardia & skipped or stopped ventricular function.  Pt had several IV drug txs that were unsuccessful.  While waiting for ambulance w/ IV capability, condition resolved on its own.  All cardiac tests returned normal.  A lesser episode occurred ~1 month later.  4/18/08 MR received from local hospital for DOS 2/22/08 with DX: Atrial Fibrillation with rapid ventricular response.  Pt presented with new onset palpitations.  PE (+) for irregular heartrate. Pt converted to Sinus rhythm with Cardizem drip. Pt transfered to ICU for higher level of care.  4/30/2008 MR received from transfer hospital for DOS 2/22-23/2008 with D/C DX: Acute onset of Atrial Fibrillation which cardioverted with inferior R waves to a normal sinus rhythm. (17 additional dx as per PMH and Labs). Pt had converted to sinus rhythm prior to admission				Y	Y	3			Y	02/20/2008	02/21/2008	1	All normal per pt. Labs and Diagnostics:  EKG shows Atrial Fibrillation.CXR showed poorly aerated lungs but otherwise WNL. Chemistry WNL except glucose 122.  Cardiac enzymes WNL. CBC WNL. Labs and Diagnostics: 2D Echo abnormal. CK 36. Troponin <0.01	OTH	PVT	Metoprolol 25 mg QD; K+ 20 mg QD; Dyazide 370/25 QD	none	PMH:  MVP, Fibromyalgia.  Allergies to Sulfa, Linkosyn and PCN PACs, PVCs, proximal atrial tachycardia, HTN, hyperlipidemia, hysterectomy, tonsillectomy, IBS, Migraine H/A, ORIF L forearm, D&C, repair of cystocele and rectocele, cough with ACE Inhibitors.			1						1	Atrial fibrillation; Atrial flutter; Cardiac disorder; Ventricular arrhythmia; Ventricular tachycardia	FLU3~SANOFI PASTEUR~U2499AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0309121	04/08/2008	MI	8.0	8		M	04/02/2008	pt. given Flu Mist on 1/10/08 despite contraindication of asthma.  Clinical staff verified questions with mother, but did not check the chart.  When she checked the chart, she found that patient had a contraindication of asthma.									Y	01/10/2008				PVT	PVT		none	asthma			1						1	Contraindication to vaccination	FLUN3~MEDIMMUNE VACCINES, INC.~50047GP~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0309136	04/08/2008	WA	2.0	2	.7	F	03/17/2008	None stated.										02/08/2008				PVT	PUB		None	None			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2516AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0309137	04/08/2008	WA	1.3	1	.3	F	03/04/2008	None stated									Y	02/01/2008				PVT	PUB		none/WCC	None			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2516AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0281U~UNK~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1252U~UNK~IM~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0309138	04/08/2008	WA	0.6	0	.6	F	03/25/2008	None stated									U	02/19/2008				PVT	PUB		None	None			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2516AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0308397	04/09/2008	NY	62.0	62		F	04/07/2008	Beginning 10/30/07, rash, redness, tingling, numbness of left arm. Photos provided, taken on Nov. 5, 2007 given to Dr on 11/13/07. Cannot lift left arm over head without pain - neck, rt arm, legs (wobbly gait). Excruciating pain in left arm constantly.				Y					N	10/30/2007	11/05/2007	6	Referred to neurologist. 2-chest X-rays - It was deemed too dangerous to have CAT scan or MRI declined EEG and needles in nerves because of existing and ongoing pain. Still considering needle to nerve Proc.	PVT	UNK	Synthroid	Fibromyalgia	Allergy to Penicillin and Sulfa, Surgery left, Ragweed and pollen (1976) Chest			1						2	Asthenia; Gait disturbance; Hypoaesthesia; Injection site erythema; Injection site pain; Injection site swelling; Pain; Pain in extremity; Red blood cell sedimentation rate increased; Chest X-ray; Erythema; Gait disturbance; Hypoaesthesia; Injected limb mobility decreased; Pain; Paraesthesia; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TDAP~UNKNOWN MANUFACTURER~~1~IM~LA~TDAP (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U2500AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|TDAP~SANOFI PASTEUR~C2862AA~UNK~IM~LA~TDAP (ADACEL)~2	USA	Emergency room visit	Influenza
0309178	04/09/2008	TN	53.0	53		F	04/07/2008	This report was received from a consumer on 27 March 2008.  A 53-year-old female patient, with a history of asthma, received a right deltoid intramuscular injection of FLUZONE (lot number U2489AA) on 08 February 2008.  Approximately one week after vaccination, on 13 February 2008, the patient began experiencing a severe headache.  Her vision initially became blurry, then deteriorated so that she was only able to see shadows and light.  She was seen by her physician, who prescribed Prednisone and ordered a series of tests including MRI, lumbar puncture, temporal artery biopsy, and blood work (results not provided).  She was subsequently seen by an ophthalmologist, who noted that her optic nerve was swollen.  Per the reporter, the patient's pupils were dilated for six weeks.  Her vision was reported to be slowly returning.  At the time of the report, the patient was being treated with Prednisone 60 mg/day for five days, then 40 mg/day for five days.  She was scheduled to follow-up with the treating physician after Prednisone therapy had concluded.  No change in vision had been noted since the previous office visit.  This consumer also reported that the patient's sister experienced flu-like symptoms following vaccination with FLUZONE; this non-serious event is captured in case 200800894.				Y					N	02/08/2008	02/13/2008	5	MRI, lumbar puncture, temporal artery biopsy, blood work.	PVT	PVT	Prednisone; Advair; Lexipro; Ibuprofen; Tums.		Asthma		200800893	1						1	Biopsy; Blood test; Headache; Lumbar puncture; Mydriasis; Nuclear magnetic resonance imaging; Optic nerve disorder; Vision blurred	FLU3~SANOFI PASTEUR~U2489A~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0309206	04/09/2008	PA	1.52	1	.5	F	04/09/2008	VARICELLA VACCINE BREAKTHROUGH. DIAGNOSED ON 4/7/08 WITH VARICELLA.  HAD ABOUT A DOZEN VESICULO-PAPULAR LESIONS ON TRUNK.									U	10/19/2007	04/05/2008	169		UNK	UNK	CLARITIN					1						1	Rash vesicular; Varicella post vaccine	DTAP~SANOFI PASTEUR~C2607AA~4~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2450AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF215AB~4~IM~RA~HIB (ACTHIB)~1|MMRV~MERCK & CO. INC.~06170~1~SC~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0304471	04/10/2008	SC	43.0	43		F	04/10/2008	After receiving the pneumonia shot my arm started throbbing - I could not move it. I ran 103 fever that night. The pain the arm was constant. A few days latewr the pain spread to my other arm and rest of my body. I currently can not get off of prednisone or I am unable to walk. I am testing positive for Parvo-Virus but it all started after that vaccination.									N	10/17/2007	10/17/2007	0	Testing positive for Parvo-Virus -	UNK	UNK		none	none	muscle and soft tissue inflamation~Pneumo (Pneumovax)~1~43.00~Patient		1						2	Burning sensation; Chest discomfort; Chills; Cough; Erythema; Injected limb mobility decreased; Injection site erythema; Injection site induration; Injection site irritation; Injection site swelling; Myalgia; Oral mucosal blistering; Pyrexia; Skin warm; Tremor; Abasia; Injected limb mobility decreased; Pain; Pain in extremity; Parvovirus B19 serology positive; Parvovirus infection; Pyrexia	FLU3~SANOFI PASTEUR~U2492AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0038U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U2492AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0038U~2~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0303731	04/11/2008	TN	57.0	57		F	04/11/2008	2 wks post receiving flu vaccine Pt. reported pain in legs and weakness and inability to get out of bed or get our of chair without using her arms.  Also pain in her upper limb girdle in her shoulder.  Seen by Dr who made clinical diagnosis of Guillain Barre.  Noted that she had a shuffling gait and was unable to pick up legs on exam.  Treated with IVIG 400mg/kg daily over 5 days.  Total dose 56 gm. 1/25/2010 Follow up: I have in the last few months begun to retain my strength. It is still not where it was before the flu shot. I still have to be very careful with stains and I have great difficulty kneeling. The kneeling issue might be related to insufficent muscle strength due to the atrophy after the Guillain Barre. I am sporadically doing yoga to try to regain my mobility and flexibility. Follow-up: The pt. was discharged from the hospital and no further information is available.					Y	5			U	11/15/2007				UNK	UNK	enalapril, hydrochlorothiazide					1						2	Diabetes mellitus; Dysstasia; Guillain-Barre syndrome; Hepatic lesion; Lumbar puncture; Mobility decreased; Pain in extremity; Transfusion; Activities of daily living impaired; Asthenia; Blood product transfusion; Gait disturbance; Guillain-Barre syndrome; Hypokinesia; Hypotonia; Muscle atrophy; Muscular weakness; Musculoskeletal pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA075~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0309355	04/11/2008	TN	28.0	28		F	04/11/2008	3 wk. history of progressive symptoms in arms and legs that started 3-4 wks after receiving flu vaccine Fine motor movements slow. Over last 7-10 days a persistent cold sensation, tingling, and weakness especially in hands. Diagnosis of Guillain Barre by MD. Pts was to received 1gm/kg/day of IVIG. Toward end of 1st infusion she developed headache and fever.  Infusion was discontinued.  Fevere and headache resolved. Given Neurontin 300 mg 1-2 po qhs for extremity pain along with ibuprofen 600 mg po tid x 5 days.  5/20/2008 MR received for OV 11/20/07 and admission DOS 11/29/2007 with DX: Guillain-Barre Syndrome. Aseptic meningitis 2' to IVIG. Dysthesias.  Pt initially presented with c/o weakness in the hands, most notable after running and intermittant numbness. Seen again 11/29/08 with c/o increasing progressive symptoms in pt's arms and now legs. Cramping and clumsiness noted in the hands with persistant cold sensation with tingling. PE (+) for muscle weakness of the bilateral APB, ADM, interossei and toe dorsiflexors.  Diminished reflexes at the biceps, brachial radialis and ankles. Sensory exam impaired to pin prick over fingers and ankles. Temp and vibration also reduced. Tx with IVIgG with development of h/a and fever suspected aseptic meningitis. 6/18/2006 Office records received from 11/12/2008-5/19/2008.  Initially seen with c/o abrupt onset of weakness of the R upper extremity as well as coldness of the extremities.  Unable to grip or start the ignition of her car. Referred to Neurologist. Seen again 2/5/08 with cold sx with recent hx of atypical Guillain Barre syndrome					Y	3			U	10/15/2007	11/08/2007	24	Labs and Diagnostics:  MRI head and neck (-). EMG/ NCV showed no definite peripheral neuropathy.  LP WNL.	UNK	UNK	birth control pills		PMH none.			1						1	Asthenia; Blood product transfusion; Feeling cold; Fine motor delay; Guillain-Barre syndrome; Headache; Pain in extremity; Paraesthesia; Pyrexia	FLU3~SANOFI PASTEUR~U2439AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0309395	04/11/2008	CA	29.0	29		F	04/01/2008	On 3/31/08 a few hours after receiving the vaccine: cough and nasal congestion worsened, rash appeared on left leg. On 04/01/08: The rash spread to both legs, arms, and torso. On 04/02/08: Pt was sent to see MD for treatment.				Y					U	03/31/2008	03/31/2008	0		OTH	PVT	Nyquil (OTC)	Mild cold, cough	None			1						1	Cough; Nasal congestion; Rash	FLU3~SANOFI PASTEUR~U2463AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0309374	04/12/2008	VA	75.0	75		F	04/12/2008	About a week after receiving the flu shot, I developed a painful rash (shingles), increased blood pressure, and insomnia lasting approximately one year. Prescriptions were given for nerve pain to no avail.  After one year I recovered. I will never get a flu shot again. I have been on high blood pressure medicine since this adverse event.				Y					Y	12/04/2005	12/11/2005	7		MIL	MIL	none	none	none			1						1	Blood pressure increased; Herpes zoster; Insomnia; Neuralgia; Pain; Rash	FLUX~UNKNOWN MANUFACTURER~~5~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0309445	04/14/2008	CO	59.0	59		M	04/14/2008	PATIENT CAME IN 04/07/2008 AND SAID HE BELIEVES HE HAS NERVE DAMAGE AND WANTED TO KNOW WHY SUCH A LONG NEEDLE WAS USED ON HIM AND WHO GAVE IT TO HIM. HE CLAIMS THE TECHNICIAN GAVE IT TO HIM AND USED A 4 TO 6 INCH NEEDLE WITH METAL HANDLE, THAT THE 1 AND 1/2 INCH DISPOSIBLE NEEDLE I SHOWED HIM WAS NOT USED ON HIM.  WE ONLY HAVE ONE SIZE ON SITE. I TOLD HIM IF HE BELIEVES HE HAS NERVE DAMAGE HE SHOULD SEE DR, HE HAS NOT SEEN ONE.										10/05/2007				UNK	PVT						1						1	Nerve injury	FLU3~SANOFI PASTEUR~U2488AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0309447	04/14/2008	AL	76.0	76		F	04/14/2008	Palpitations, restlessness, stomach discomfort pharyngeal edema, headache, dizziness, chest pain, decreased blood pressure. 7/28/08-death certificate received; COD:respiratory failure. Chronic obstructive pulmonary disease.	Y	12/06/2007							N	11/07/2007	11/13/2007	6		UNK	UNK		COPD/Emphysema		Death~Influenza (Seasonal) (no brand name)~~76.30~Patient		1						1	Blood pressure decreased; Chest pain; Dizziness; Headache; Palpitations; Pharyngeal oedema; Restlessness; Stomach discomfort	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0309464	04/14/2008	CA	11.0	11		F	03/10/2008	Bilateral arm pain that developed 4 days after immunizations given. Left arm pain greater than right. Pain is diffuse, not localized at deltoid and weakness.									U	03/04/2008	03/09/2008	5		PUB	PUB	None					1						1	Muscular weakness; Pain in extremity	FLU3~SANOFI PASTEUR~U2441AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1448U~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2532AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC2B019BA~1~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0309515	04/15/2008	UT	1.0	1	.0	F	03/18/2008	Should received age-inappropriate flu vaccine, Fluarix, licensed for age 18 year an older.									Y	03/05/2008				PUB	PUB	Unknown	None	Unknown			1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA322BA~1~IM~RL~INFLUENZA (SEASONAL) (FLUARIX)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB215AA~1~IM~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0867U~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C45894~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1765U~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0309534	04/15/2008	MN	1.25	1	.3	F	04/15/2008	2 days after MMR/varicella/Dtap/flu vaccines, developed a measles-like rash that lasted about 2 weeks. 1 week after same, developed a varicella rash lasting a few days.									Y	11/29/2007	12/03/2007	4		PVT	PVT						1						1	Rash morbilliform; Rash vesicular	DTAP~SANOFI PASTEUR~C2760AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2477AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0808U~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1002U~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0309556	04/15/2008	NE				U	03/03/2008	A nonserious report of expired dose of vaccine administered has been received from a nurse concerning a child above two-years old. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. No relevant medical or drug history information was reported. The patient was given FluMist on 29-Feb-2008. The FluMist had expired on 26-Feb-2008. No adverse events were reported from this error. Rechallenge is not applicable. Causality assessment is not applicable. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	02/29/2008	02/29/2008	0		OTH	OTH					MEDI0006604	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0309557	04/15/2008	PA	2.0	2	.3	F	03/18/2008	A non-serious report of administration of expired FluMist has been received from a nurse concerning a 27-month-old female.  This case is submitted in accordance with an article on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 11-Mar-2008.  The FluMist had expired on 10-Mar-2008.  The reporter stated that she received 100 doses of FluMist from the vaccines clinic on 22-Feb-2008 and the vaccine expired on 10-Mar-2008.  The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients.  The patient had no adverse events at the time the report was received, neither as of 18-April-2008 when the office was contacted for follow-up information. The event has resolved.  It was not reported whether or not FluMist was re-administered.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  Follow-up information received 18-Apr-2008 and incorporated into he narrative: no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.									Y	03/11/2008	03/11/2008	0		PVT	OTH	Concomitant drug(s) not reported				MEDI0006659	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0309558	04/15/2008	PA	4.0	4		M	03/18/2008	A non-serious report of administration of expired FluMist has been received from a nurse concerning a four year old male. The case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 11-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the vaccines for the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continue to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. No adverse events were reported. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006659; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667;MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.									Y	03/11/2008	03/11/2008	0		PVT	OTH	None				MEDI0006660	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500498F~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0309559	04/15/2008	PA	4.0	4		M	03/18/2008	A non-serious report of administration of expired FluMist has been received from a nurse concerning a four-year-old male.  This case is submitted in accordance with an article on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 11-Mar-2008.  The FluMist had expired on 10-Mar-2008.  The reporter stated that she received 100 doses of FluMist from the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008.  The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients.  No adverse events were reported.  The event has resolved.  It was not reported whether or not FluMist was re-administered.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.									Y	03/11/2008	03/11/2008	0		PVT	OTH	Concomitant drug(s) not reported				MEDI0006661	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0309560	04/15/2008	PA	2.0	2	.4	M	03/18/2008	A non-serious report of administration of expired FluMist has been received from a nurse concerning a 29-month-old male. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient recovered FluMist on 12-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she recovered 100 doses of FluMist from the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had no adverse events at the time the report was received. Neither as of 18-Apr-2008 when the office was contacted for follow-up information. No adverse events were reported. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006659; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672;MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684. The patietn received FLUMIST on 12-Mar-2008.									Y	03/12/2008	03/12/2008	0		PVT	OTH	None; Concomitant Drugs(s) Not Reported		None		MEDI0006662	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0309561	04/15/2008		4.0	4		F	03/18/2008	A non-serious report of administration of expired FluMist has been received from a nurse in concerning four-year old female. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 12-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. No adverse events were reported. The event has resolved.  It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006659; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.									Y	03/12/2008	03/12/2008	0		PVT	OTH	None		None		MEDI0006663	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500498~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0309562	04/15/2008	PA	3.0	3		F	03/18/2008	A non-serious report of administration of expired FluMist has been received from a nurse concerning a 38-month-old female.  This case is submitted in accordance with an article on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 12-Mar-2008.  The FluMist had expired on 10-Mar-2008.  The reporter stated that she received 100 doses of FluMist from the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008.  The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients.  No adverse events were reported.  The event has resolved.  It was not reported whether or not FluMist was re-administered.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006659; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684. Follow up information received 18-Apr-2008 and incorporatedinto the narrative: no adverse event occurred.									Y	03/12/2008	03/12/2008	0		PVT	OTH	Concomitant drug(s) not reported				MEDI0006667	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0309563	04/15/2008	PA	3.0	3		M	03/18/2008	A non-serious report of administration of expired FluMist has been received from a nurse concerning a 36-month old male. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 12-Mar-2008. The FluMist had expired on 10-Jan-2008. The reporter stated that she received 100 doses of FluMist from the vaccines program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinical did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. No adverse events were reported. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006659; MEDI-0006669; MEDI-0006670; MEDI-0006671 MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.									Y	03/12/2008	03/12/2008	0		PVT	OTH	Concomitant Drug(s) not reported				MEDI0006668	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0309564	04/15/2008	PA	4.0	4		F	03/18/2008	A non-serious report of administration of expired FluMist has been received from a nurse concerning a four-year-old female.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 12-Mar-2008.  The FluMist had expired on 10-Mar-2008.  The reporter stated that she received 100 doses of FluMist from the Vaccines For Children Program on 22-Feb-2008 and the vaccines expired on 10-Mar-2008.  The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients.  No adverse events were reported.  The event has resolved.  It was not reported whether or not FluMist was re-administered.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006659; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.									Y	03/12/2008	03/12/2008	0		PVT	OTH	Concomitant drug(s) not reported				MEDI0006670	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0309565	04/15/2008	PA	3.0	3		F	03/18/2008	A non-serious report of administration of expired FluMist has been received from a nurse concerning a 44-month-old female. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 13-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continues to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. No adverse events were reported. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006659; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.									Y	03/13/2008	03/13/2008	0		PVT	OTH					MEDI0006672	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0309566	04/15/2008	PA	3.0	3		M	03/18/2008	A non-serious report of administration of expired FluMist has been received from a nurse concerning a 39-month-old male. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 13-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to given it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had no adverse events at the time the report was received. Neither as of 18-Apr-2008 when the office was contacted for follow-up information. No adverse events were reported. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006660; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006659; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.									Y	03/13/2008	03/13/2008	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0006676	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0309567	04/15/2008	PA	4.0	4		M	03/18/2008	A non-serious report of administration of expired FluMist has been received from a nurse concerning a four-year old male.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 14-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the vaccine program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. No adverse events were reported, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670;  MEDI-0006671;  MEDI-0006672;  MEDI-0006673;  MEDI-0006674;  MEDI-0006675;  MEDI-0006676;  MEDI-0006659;  MEDI-0006678;  MEDI-0006679;  MEDI-0006680;  MEDI-0006681;  MEDI-0006682;  MEDI-0006683;  MEDI-0006684.									Y	03/14/2008	03/14/2008	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0006677	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0309568	04/15/2008	PA	4.0	4		F	03/18/2008	A non-serious report of administration of expired FluMist has been received from a nurse in the USA concerning a four-year-old female. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 14-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the Vaccines For Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. No adverse events were reported. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-000662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006659; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.										03/14/2008	03/14/2008	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0006679	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0309569	04/15/2008	PA	4.0	4		M	03/18/2008	A non-serious report of administration of expired FLUMIST has been received from a nurse concerning a four-year-old male. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither medical history nor concomitant medications were provided. The patient received FLUMIST on 14-Mar-2008. The FLUMIST had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FLUMIST program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had no adverse events at the time the report was received. Neither as of 18-Apr-2008 when the office was contacted for follow-up information. No adverse events were reported. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter:  MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006659; MEDI-0006682; MEDI-0006683; MEDI-0006684.									Y	03/14/2008	03/14/2008	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0006681	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0309570	04/15/2008	PA	2.0	2	.4	F	03/18/2008	A non-serious report of administration of expired FluMist has been received from a nurse concerning a 28-month-old female. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 14-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. No adverse events were reported. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006659; MEDI-0006684.									Y	03/14/2008	03/14/2008	0		PVT	OTH					MEDI0006683	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500498p~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0309571	04/15/2008	PA	4.0	4		F	03/18/2008	A non-serious report of administration of expired FLUMIST has been received from a nurse concerning a four-year-old female.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  Neither medical history nor concomitant medications were provided.  The patient received FLUMIST on 17-Mar-2008.  The FLUMIST had expired on 10-Mar-2008.  The reporter stated that she received 100 doses of FLUMIST from the Vaccines for Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008.  The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients.  No adverse events were reported.  The event has resolved.  It was not reported whether or not FLUMIST was re-administered.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006659.									Y	03/17/2008	03/17/2008	0		PVT	OTH	Concomitant drug(s) not reported				MEDI0006684	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0292956	04/16/2008	CA	82.0	82		F	03/26/2008	Information has been received from a physician concerning a female with diabetes, hyperlipidaemia, seasonal allergy and anemia secondary to a history of small intestine arteriovenous malformation (20 SEP 2007) who on 20-SEP-2007 was vaccinated subcutaneously into the left upper arm with ZOSTAVAX (Oka/Merck) (lot # 658208/0886U). Concomitant therapy included influenza virus vaccine (unspecified), metformin, PAXIL, LIPITOR, RYTHMOL, diltiazem hydrochloride, aspirin, hydrochlorothiazide, estrogens, PREMARIN and vitamins (unspecified). On 20 SEP 2007 the patient developed a 'vascular rash following the vaccination with ZOSTAVAX (Oka/Merck). The patient was seen in the office on 12 OCT 2007 for a rash that the patient report had started a couple of weeks ago. The rash was generalized itchy rash with lesions, some with crusted covering the whole body (limbs, trunk, front and back). The patient developed a secondary infecting on 29 OCT 2007 that was described as olecranon bursitis and or cellulitis on her left elbow, which resolved with antibiotic treatment. The patient was referred to a dermatologist who felt that the rash was related to ZOSTAVAX (Oka/Merck), and not pre-existing eczema. It was reported that the rash gets better and almost disappears and then breaks out with new lesions and itching. The patient was last examined on 06 FEB 2008, at which time there were intact vesicles. Lab diagnostic studies were performed, of which the results were not reported. At the time of reporting the patient had not yet recovered. There was no product quality complaint; Additional information has been requested. Additional information is not available. Follow up information was received from a physician who reported that the patient was seen on follow up on 7 FEB 2008 at which time the patient was still getting vesicles on her body, except they were now smaller than previously. The physician described them as teeny tiny varicella like diseminated blisters. Additional information has been requested.				Y					N	09/20/2007	09/20/2007	0	diagnostic laboratory; complete blood cell;	PVT	PVT	aspirin; LIPITOR; diltiazem hydrochloride; PREMARIN; hydrochlorothiazide; metformin; PAXIL; RYTHMOL; vitamins (unspecified)	Diabetes; Hyperlipidaemia; Seasonal allergy; Anaemia;Paroxysmal atrail fibrillation; Hypertension	Arteriovenous malformation		WAES0802USA01845	1						2	Bursitis; Cellulitis; Full blood count; Infection; Laboratory test; Rash generalised; Rash pruritic; Rash vesicular; Scab; Skin lesion	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|VARZOS~MERCK & CO. INC.~0886U~UNK~SC~LA~ZOSTER LIVE (ZOSTAVAX)~2	USA	Emergency room visit	Influenza
0309594	04/16/2008	CO	6.0	6		F	04/10/2008	Received FluMist on 1/11/08. Approx 7-10 days later became weak with multiple episodes of falling to ground, difficulty walking, ataxia. Weakness progressive leading to breathing problems. Neurology and genetics diagnosed congenital disease - Leigh's disease which may have been 1st manifested after this vaccine.Swallowing problems, 5/15/08-death certificate received-final cause of death Leigh's syndrome. 5/1/08-records received for DOS 3/15-4/5/08-DX: Leigh's encephalopathy syndrome. Respiratory failure. Sepsis. Presented to ED and subsequently transferred. About 2 months ago received FluMist and since then became weak and wobbly. Weak prior to vaccination but more so after vaccination and was receiving physical and occupational therapy. Starring episodes usually at night. Became more limp. Appears sleepy acts as if drunk. Ataxia. With thes episodes has become unresponsive and starring with them. No clonic seizure acitivity. after surgery remained intubated with mechanical ventilation and required CPAP. Neurologic status became more obtunded and unresponsive. Fever. Fevers secondary to brain inflammation due to Leigh syndrome. Withdrawn from life support and expired.	Y	04/05/2008	Y	Y	Y	20			N	01/11/2008	01/20/2008	9	Abnormal MRI; Genetic mutation 8993 T-C for mitochondrial disease 5/1/08-records received-EEG negative. MRI 2/08 showed abnormal basal ganglia. Sleep study 3/19/08-hyperventilation and obstructive sleep apnea.  G-tube insertion on 3/21/08-Repeat MRI shows further note of worsening of lesions in brain consistent with Leigh syndrome. Blood and wound culture positive for staph.	PVT	PUB		Weak prior to vaccination. Two months of respiratory problems at night when asleep described as sudden inspiratory gasp and suddenly relieved.	5/1/08-records received- PMH: born at 29 weeks on ventilator for pneumonia. Hospitalized for 3 months. Strabismus repair, PE tubes and adenoidectomy. Rotavirus and hospitalization. Developmental delay. Did not receive 5 year old vaccinations.			1						1	Asthenia; Ataxia; Congenital anomaly; Dyspnoea; Expired drug administered; Fall; Gait disturbance; Gene mutation identification test; Mitochondrial encephalomyopathy; Nuclear magnetic resonance imaging abnormal; Asthenia; Ataxia; Blood lactic acid increased; Continuous positive airway pressure; Death; Depressed level of consciousness; Disorientation; Dysphagia; Dyspnoea; Electroencephalogram normal; Encephalitis; Expired drug administered; Fall; Fatigue; Gait disturbance; Gastrointestinal tube insertion; Hyperreflexia; Hyperventilation; Inflammation; Mechanical ventilation; Mitochondrial cytopathy; Mitochondrial encephalomyopathy; Nuclear magnetic resonance imaging brain abnormal; Photophobia; Pyrexia; Respiratory failure; Sepsis; Sleep apnoea syndrome; Sleep study abnormal; Somnolence; Staring; Unresponsive to stimuli	FLUN3~MEDIMMUNE VACCINES, INC.~500490P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~In5C0490P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Results in Death	Influenza
0309607	04/16/2008	AL	1.0	0	1	F		Fever - Pustules; Varicella outbreak after vaccination; Motrin - Tylenol									Y	11/09/2007	04/07/2008	150		PUB	PUB	No	No	Failure to thrive			1						1	Pyrexia; Rash pustular; Varicella	FLU3~SANOFI PASTEUR~UT2473HA~2~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0500F~4~UN~RA~HIB + HEP B (COMVAX)~1|IPV~SANOFI PASTEUR~21009~4~UN~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~01844~1~UN~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B53981H~4~UN~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0309764	04/16/2008	MI	74.0	74		M	03/26/2008	Information has been received from a 74 year old male with a history of shingles in JAN-2005 and an allergic reaction to tetracycline (he breaks out in a rash) who on 25-OCT-2007 was vaccinated with a single dose of ZOSTAVAX.  Concomitant therapy included influenza virus vaccine (unspecified) administered on 25-OCT-2007 and 11 other prescription medications therapy unspecified.  On approximately 27-OCT-2007 a couple of days after shot (also reported as sometime during the second week in NOV-2007) the patient reported feeling lethargic, tired and the back of his head itched really bad.  The itch started in his scalp and then went all the way down his back.  He did not have any type of outbreak or rash in either area.  The patient stated that he went to the physician and they said he has post herpetic neuralgia.  No diagnostic labs were performed.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  Additional information has been requested.				Y					N	10/25/2007	10/27/2007	2	None	OTH	OTH	[Therapy unspecified]	Drug hypersensitivity	Shingles		WAES0712USA01363	1						1	Lethargy; Post herpetic neuralgia; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~UN~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0310012	04/16/2008	CA	59.0	59		M	03/26/2008	Information has been received from a physician concerning a 61 year old male with asthma, eczema, benign prostatic hyperplasia and pollen allergy who on 28-DEC-2007 was vaccinated subcutaneously into the left upper arm with a single dose of Zostavax (Oka/Merck) and influenza virus vaccine (unspecified), which was administered in the right upper arm.  Concomitant therapy included saw palmetto.  On 01-JAN-2008, four days after being administered the vaccines; the patient developed a macular-papular rash on his back.  The rash was reported to have started on the right mid-thorax and spread to the left mid-thorax with a localized area under the left breast.  The patient complained of a sunburn-like burning in the area of the rash.  The patient self treated the rash DESONIDE Cream and the rash resolved.  The rash returned after the DESONIDE Cream was discontinued.  The patient was examined in the office on 29 JAN 2008 at which time the exam revealed a 6 cm rash.  The burning sensation was improved at that time.  The physician recommended that patient continue to apply the DESONIDE Cream as needed.  At the time of reporting the patient had not yet recovered.  There was no product quality complaint.  There were no lab diagnostic studies performed.  Additional information has been requested. In follow up the physician indicated that the patient received both ZOSTAVAX (Merck) (lot# 14144) and FLULAVAL (lot# AFLLAAUWAAVN708) the same day. Four days after the patient received the injections he developed irritation, sunburn and chill-like feeling, no fever. The patient used hydrocortisone 1% cream with relief. The patient was seen on 29-JAN-2008 and had a maculopapular rash below his shoulder blades he recovered on 29-Feb-2008. Additional information has been requested.									N	12/28/2007	01/01/2008	4	None	OTH	OTH	saw palmetto	Asthma; Eczema; Benign prostatic hyperplasia; Pollen allergy			WAES0801USA06043	1						1	Burning sensation; Rash maculo-papular	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0310181	04/16/2008	FL	64.0	64		M	03/26/2008	Information has been received from a 64 year old male consumer with hiatal hernia cancer of the leg, lower back problems, allergies to sulfa and CIPRO, with a history of prostatitis who on 28-SEP-2007 was vaccinated with 0.5 ml subcutaneous in the left arm of Zostavax (Oka/Merck) (lot# 108484).  Concomitant vaccination included influenza in the opposite arm (right).  Concomitant medications included CLARITIN, FLONASE, NEXIUM, ADVAIR, baby aspirin, and FLOMAX.  There was no reported history of chicken pox, and no reported recent exposure to chicken pox or herpes zoster.  He reported that later that evening (28-SEP-2007), he developed a blister-like rash on the middle of his back.  He also experienced a burning and itching sensation all over his body.  The next day (29-SEP-2007), he developed red, itchy, non-fluid bumps on his chest area.  Since then the red itchy bumps developed in any area that was exposed to heat or became warm.  He has had the rash on the back of his neck, crotch area, legs, palms of his hands, and feet.  The rash usually cleared if he self administered BENADRYL and applied cool compresses.  On an unspecified date, he was examined by his physician and was prescribed a tapered dose of prednisone for 6 days.  He developed hives and redness over his entire body after the first day of starting the prednisone (date not reported).  By the end of the sixth day of prednisone, the hives had resolved and he was back to the state he was prior to starting the prednisone.  The blisters on his back have scabbed and healed.  The patient's physician reported that on day # 4 post vaccination (02-OCT-2007), he developed a red itchy rash at the injection site.  Medical attention sought for the site events was not reported.  There was no reported collection of a specimen for PCR or a direct fluorescent antibody.  The physician reported that on an unspecified date, the patient had recovered.  It was noted that the patient started radiation therapy three weeks after the administration of Zostavax (Oka/Merck).  A product quality complaint was not reported.  This is one of two reports from the same source.  Additional information has been requested.				Y					Y	09/28/2007	09/28/2007	0	Unknown	PVT	OTH	aspirin, mg; NEXIUM, mg; FLONASE; ADVAIR; CLARITIN; FLOMAX (MORNIFLUMATE), mg; ZANTAC	Hiatus hernia; Sulfonamide allergy; Cancer; Allergic reaction to antibiotics; Spinal disorder	Prostatitis		WAES0801USA01496	1						1	Blister; Burning sensation; Injection site pruritus; Injection site rash; Pruritus; Rash; Rash erythematous; Rash papular; Rash pruritic; Scab; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0310212	04/16/2008	FL	68.0	68		F	03/26/2008	Information has been received from a 68-year-old female with a sulfonamide allergy and no pertinent medical history, who in October 2007 (towards the end of October), was vaccinated subcutaneous once with a 0.65 ml dose of ZOSTAVAX. Concomitant therapy included HCTZ and DILTIAZEM XR. In October 2007 (towards the end of October), the patient stated she is still sore at the injection site. The patient also stated that she developed bronchitis shortly after receiving the shot. She has also developed muscle pain, can't event walk, and can't even bend my fingers. She also has pain in her feet and even my fingernails hurt. The patient did not seek medical attention. No diagnostic labs were performed. The patient started taking LYRICA 6 days ago and it seems to help the pain. At the time of the report the patient's status was recovering. A product quality complaint was not involved. Follow-up information received 04-FEB-2008 via a phone call with a physician. The physician reported that the patient did not call the office to report these adverse events. He stated he would follow-up with the patient on the reported adverse events. Follow-up received 25-FEB-2008 from the consumer: The patient stated I have been feeling like I have pins and needles in my hands and feet. I Have a hard time getting up and walking after sitting, and I Have had two major falls where I had to go to get x-rays. I have gained 13 pounds. She also stated that her physician did bloodwork but she didn't know what he was looking for. Her physician referred her to a neurologist because of severe pain who performed an MRI and checked her for lupus, lyme disease, and B-12 deficiencies. All the tests came back negative. The patient is currently taking CELEBREX and NAPROXEN and switched from LYRICA to GABARONE. The patient also stated  about two weeks post vaccination, her finger nails got paper thin and started feeling. Her hands and feet got numb and her tongue is numb too. She said it feels like the end of my tongue is burned. The patient was also vaccinated with influenza virus vaccine (unspecified) the same day she received ZOSTAVAX. Additional information has been requested.									N	10/01/2007	10/01/2007	0	magnetic resonance - negative; diagnostic laboratory - B-12 deficiencies - negative; diagnostic laboratory - lupus test - negative; diagnostic laboratory - lyme disease test - negative; X-ray - results not reported; diagnostic laboratory - bloodwork - results not reported	OTH	OTH	DILTIAZEM XR; HYZAAR	Sulfonamide allergy			WAES0801USA00515	1						1	Abasia; Blood test; Borrelia burgdorferi serology negative; Bronchitis; Burning sensation; Dysstasia; Fall; Gait disturbance; Hypoaesthesia; Hypoaesthesia oral; Injection site pain; Myalgia; Nuclear magnetic resonance imaging; Pain in extremity; Paraesthesia; Paraesthesia oral; Vitamin B12 normal; Weight increased; X-ray	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0310264	04/16/2008		15.0	15		F	04/07/2008	Information has been received through the pregnancy registry from a nurse practitioner concerning a 14 year old female with a history of anaemia and no allergies, who on 07-NOV-2007 and 09-JAN-2008 was vaccinated intramuscularly with the first and second 0.5 mL dose of Gardasil (Lot # 658490/0802U same Lot# for both doses), respectively. Concomitant therapies included HAVRIX, influenza virus vaccine (unspecified), MENACTRA, hormonal contraceptives (unspecified) and Varivax (MSD) (Lot# 658574/1269U). On 05-MAR-2008 the nurse practitioner reported that the patient is pregnant. It was reported that the patient had consistent bleeding so she didn't think she was pregnant. It was believed that the patient was 26 weeks pregnant on 09-JAN-2008. The patient sought unspecified medical attention. Diagnostic studies performed included ultrasound (everything is normal), blood work-results unknown and urine pregnancy testing in February 2008. At the time of this report the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. 02/17/2010 It was reported that the patient moved out of state in her third trimester and the nurse practioner has had no further contact with the patient. This patient is lost to follow up. No further information is available.									U	11/07/2007	11/07/2007	0	ultrasound normal; diagnostic laboratory unknown; urine beta-human 02/08 unknown	OTH	OTH	hormonal contraceptives		Anaemia		WAES0803USA00772	1						1	Drug exposure during pregnancy; Menorrhagia; Pregnancy test positive; Ultrasound scan normal	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~0802U~1~IM~UN~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~~UNK~SC~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~1269U~UNK~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0310306	04/16/2008	NY	16.0	16		F	04/07/2008	Information has been received from a registered nurse concerning her 16 year old daughter with headaches who on an unspecified date was vaccinated with a second dose of GARDASIL. Concomitant therapy included influenza virus vaccine (unspecified) on an unspecified date. Subsequently 24 hours after receiving the second dose of GARDASIL the patient experienced dizziness that lead to a headache. Medical attention was sought. At the time of reporting the patient had recovered. No further information was provided. Additional information has been requested. 02/17/2010 Subsequently on 04-DEC-2007 at 8 AM, 12 hours after receiving the second dose of GARDASIL the patient experienced dizziness (severe-could not stand up) severe headache, lightheadedness, no nausea and no fever. Medical attention was sought. Did not take to hospital-thought was a virus going around. On 07-DEC-2008 the patient had recovered. No further information was provided. Additional information is not expected.				Y					Y	12/03/2007	12/04/2007	1		PVT	OTH		Headache 02/17/2010 Sinus headache; Tension headache			WAES0803USA00350	1						1	Dizziness; Dizziness; Dysstasia; Headache; Immediate post-injection reaction	FLU3~SANOFI PASTEUR~U2506AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1446U~2~IM~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0310464	04/16/2008					F	04/14/2008	Information has been received from a consumer concerning his daughter who was vaccinated with all three doses of Gardasil on unspecified dates (lot #'s not provided).  Concomitant therapy included influenza virus vaccine (unspecified).  On approximately 01-MAR-2008 the patient experienced an autoimmune disease after receiving the influenza virus vaccine and Gardasil.  The patient's autoimmune disease persisted and she sought unspecified medical attention.  No further information is available.									N		03/01/2008		Unknown	OTH	OTH			None		WAES0803USA03861	1						1	Autoimmune disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~3~UN~UN~HPV (GARDASIL)~1	USA		Influenza
0310016	04/18/2008		79.0	79		M	04/18/2008	We received from a health care professional via the Medical Communication the following information on 07 APR 2008: A 79-year-old man, born on 03 OCT 1928, was vaccinated with Fluvirin, batch-no. 80684, i.m. on 29 OCT 2007.  On 12 NOV 2007 the patient started to have problems.  He had trouble walking, swallowing and could not move legs at onset of symptoms.  Patient was hospitalised for evaluation, and received tracheotomy as result of difficulties. Over the past three months the patient has had some improvement in leg movement and swallowing.  Previous vaccination(s) was (were) well tolerated.  Company assessment: Seriousness criterion: hospitalisation.  Causality: insufficient data.  We have not enough medical details to assess the case definitely.  Expectedness assessment according to SPC/US label: The reported symptoms are not expected after vaccination with Fluvirin.  No change in benefit-risk-ratio.  No measures necessary.  5/2/08 Reviewed hospital medical records for 12/8/2007-2/4/2008. FINAL DX: severe dysphagia; chronic aspiration; LLL abscess; congestive cardiomyopathy, possibly related to alcoholism; septic shock; cardiogenic shock; shocked liver syndrome; urinary retention w/catheter; hyponatremia; thrombocytopenia. Records reveal patient experienced weakness w/falls, fatigue, anorexia, decreased oral intake, cough & secretions w/food or liquids, bilateral leg edema w/bluish discoloration all progressing to the inability to walk over approx 2 weeks.  Denied alcohol for past 10 days. Ischial pressure ulcers noted on admission along w/peripheral neuropathy likely noted to be related to alcohol abuse. Consults: wound care, neuro, cardio, ID, palliative care, uro.  Developed tachycardia, hypotension, worsening infiltraes & sepsis.  Transferred to ICU by 12/11/07 on pressors, antibiotics, TPN, thoracentesis & BiPap, never intubated.  PEG tube inserted.  Improved minimally & transferred to rehab facility on continued IV antibiotics.  Patient refused PT/ST/OT or further neuro w/u but accepted PT at transfer.  5/2/08 Reviewed hospital medical records for 2/17-2/21/2008. FINAL DX: aspiration pneumonia secondary to severe dysphagia; dysphagia; poor nutrition; diarrhea secondary to poor oral absorption of PEG feeds; abdominal pain secondary to tube feeds; HTN; depression; Stage II sacral decubitus. Records reveal patient experienced severe resp distress & hypotension due to recurrent aspiration while at rehab facility. Tx w/IV antibiotics & supplemental O2.  Improved minimally & transferred back to rehab facility.   Patient returned to hospital 2/21-2/27/2008. FINAL DX: aspiration; neuromuscular disease unknown etiology. Records reveal patient readmitted for gen weakness & altered mental status.    Transfused for anemia.  Intubated & on mechanical ventilation.  Neuro consult done & suspected chronic inflammatory demyelinating polyneuropathy.  Recommended transfer to higher level of care for further neuro w/u.    4/29/08 Reviewed hospital medical records for 2/27-3/21/2008. FINAL DX: motor/sensory axonal neuropathy of unclear etiology; muscle fibrosis c/w possible muscular dystrophy; aspiration pneumonia, resolving; left anterior uveitis left eye, resolving; multiple electrolyte abnormalities; anemia related to chronic disease & poor nutrition. Records reveal patient experienced approx 5 mos of progressive weakness, dysphagia & weight loss.  Now had PEG feeding tube.  Had 2 previous admits in outlying hospitals.  Intubated & in neuro ICU.  Exam revealed left eye w/corneal clouding & ptosis.  Areflexic.  Severe atrophy bilateral LEs.  Increased tone right side.  Unable to walk due to weakness. Consults by rheum, ID, ophthalmo & neuro.  All rheumatology testing was neg. Trached 3/7/08.  Transferred for further rehabilitation. .					Y	92			N	10/29/2007	11/12/2007	14	12/8/07-2/4/08 Hospital LABS: WBC 21K (H), plts as low as 106. CXR revealed LLL abscess.  Chest CT scan abnormal.  Head CT revealed chronic-appearing lacunar infarcts in basal ganglia.  ESR 94 (H), CRP 12 (H). EMG/NCS incomplete but abnormal.  Pleural fluid revealed complex peripneumonic effusion bordering on empyema.  Lung biopsy, cytology inconclusive.  Swallowing study grossly abnormal.  Prealbumin 5 (L).  Troponin elevated.  AST 611 (H), ALT 405 (H).  Blood c/s (+) Enterobacter. Sputum c/s (+) for acinetobacter baumannii, stenotrophomonas maltophila & VRE.  Echocardiogram revealed severe global LV systolic dysfunction w/ ejection fraction 10-15%.  2/17-2/21/2008 Hospital LABS: WBC 19.6 (H), neutros 86%.  CXR revealed bilateral infiltrates vs. atelectasis.  Sputum c/s (+) MRSA & Providencia stuartii.  MRI head revealed old infarcts & atrophy.   2/21-2/27/2008 Hospital LABS: WBC 19.  Sputum c/s (+) MRSA & Providencia stuartii.  Hgb 7.8.  2/27-3/21/2008 Hospital LABS: MRI brain & spine WNL.  CT of chest/abdomen/pelvis revealed aspiration pneumonis & bilateral small pleural effusions & atelectasis, simple hepatic cyst & cholelithiasis.  Partial EMG/NCS c/w motor/axonal neuropathy vs possible motor/sensory axonal neuropathy.  CSF WNL.  Repeat EMG/NCS on 3/6/08 abnormal & c/w sensory axonal & external neuropathy.  Left sural nerve & left gastrocnemius muscle biopsy c/w possible muscular dystrophy.  TEE was WNL w/EF 65%	OTH	OTH	No other medications	Unknown	PMH: HTN, CAD, depression, tubular adenoma s/p resection & serial colonoscopies, chronic alcoholism x 20 yrs, recent recurrent episodes of aspiration pneumonia, ex-smoker, weight loss of approx 15 lbs in a month.		MA20080544	1						1	Dysphagia; Gait disturbance; Guillain-Barre syndrome; Movement disorder; No reaction on previous exposure to drug; Surgery; Tracheostomy; Abdominal distension; Asthenia; Barium swallow abnormal; Cardiac disorder; Dehydration; Diarrhoea; Dysphagia; Endotracheal intubation; Guillain-Barre syndrome; Lumbar puncture; Malnutrition; Neuropathy peripheral; Pneumonia aspiration; Respiratory distress; Tracheostomy; Urinary tract infection; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80684~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80684~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Hospitalisation	Influenza
0310021	04/18/2008					U	04/15/2008	Initial case was received on 08 April 2008 from a health care professional affiliated with an organization under OTIS reference number 0711271442, who received this information from the patient's parent. A newborn infant (gender not provided), had been diagnosed with multicystic renal dysplasia, ventricular septal defect, nos, atrial septal defect, nos and single umbilical artery 115 days after they had received a transplacental dose of Fluzone (lot number not reported) on 30 October 2007. The infant had also received the following medications transplacentally which consisted of prenatal vitamins q.d., Enbrel 50mg weekly injections (20 June 2007 to 30 July 2007), and one steroid, NOS injection on 30 November 2007. The infant's mother had a past medical history of rheumatoid arthritis which was diagnosed in 2006. The infant's date of conception had been 04 July 2007 and they were born at 35 weeks gestational age on 22 February 2008. While in utero, the mother of the baby had been diagnosed by ultrasound with a short umbilical cord and two vessel cord. The ultrasound also confirmed the presence of a cyst on the baby's kidney (non-functional). A glucose tolerance test was performed on 15 January 2008; results were reported as failed one hour. A non-stress test was performed on 19 February 2008 (results not provided). An ultrasound was also performed on 19 February 2008 and revealed that the baby had not been growing so labor was induced on 22 February 2008. At the time of delivery, the infant was cyanotic and had respiratory problems. The infant was admitted to the neonatal intensive care unit (NICU) after delivery and placed on a ventilator for 24 hours after delivery. The cyanosis and respiratory problems resolved within 24-48 hours after delivery. The baby received a blood transfusion on 23 February 2008 due to complications from the short umbilical cord resulting in less blood flow during pregnancy. The infant remained in the NICU for 21 days (released on 13 March 2008). According to the reporter, the physicians felt the heart defects were related to the two vessel umbilical cord and birth defects were not related to exposures during pregnancy. No further information was provided at the time of the report.					Y	21			N		02/22/2008		During intrauterine life: 05/Nov/2007, Ultrasound, (detected cyst on kidney); 16/Nov/2007, Ultrasound, (confirmed cyst on kidney (non-functional) and two vessel cord; 19/Feb/2008, Ultrasound, (baby not growing)	UNK	UNK	PRENATAL VITAMINS, ENBREL, STEROID NOS		The infant's mother had a history rheumatoid arthritis and received Enbrel once weekly from 20/Jun/2007 to 30/Jul/2007 and also received one steroid injection (nos) on 30/Nov/2007.  The infant's mother had taken prenatal vitamins and reportedly drank one serving of coffee twice weekly between 05/Feb/2008 and 22/Feb/2008.		200801027	1						1	Drug exposure during pregnancy; Foetal disorder; Glucose tolerance impaired; Premature baby; Ultrasound scan abnormal	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0310054	04/18/2008	NY	48.0	48		F	04/18/2008	Sore right arm immediately after vaccination. Couldn't lift arm. Still taking NSAIDS and physical therapy. Notified Employee Health re: above 4-1-08. Spoke with patient 4-18-08 to file report.									U	10/29/2007	10/29/2007	0	None	PVT	PVT	Lotrel - Vitamins	denied	Hypertension, Migraines, Back surgery L2 + L3. Nodule on parathyroid gland removed 12-07.			1						1	Immediate post-injection reaction; Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2451AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0310069	04/18/2008	NE	1.1	1	.1	M	02/29/2008	Developed varicella rash throughout body 4 days after shot given.									U	02/20/2008	02/24/2008	4		PUB	UNK		ear infection	None			1						1	Varicella post vaccine	FLU3~SANOFI PASTEUR~U2515AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB225CA~1~UN~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1305U~1~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C45152~4~UN~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1656U~1~UN~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0310079	04/18/2008	NY	73.0	73		M	04/18/2008	Over course of 11 days worsening LE weakness and ataxia, low grade fever with chills and diarrhea, loss of sensation and proprioception; progressed to inbility to walk, diagnosis of Guillain-Barre Syndrome; impaired coordination.  Hospitalized 10/20/07, Discharged to home March 14, 2008 from rehab.  Unable to walk, confined to wheelchair and walker.  Requires assistance with all ADLS.  5/01/2008 MR received for ER visit 10/18/2007 and admission DOS 10/20-11/08/2207 with D/C DX: Guillain-Barre syndrome. Pt initially presented to PCP with lower extremity weakness and a shuffling gait. Pt had developed diarrhea, fever and chills initially, then lower extremity weakness with gait disturbance as well as constipation and bladder dysfunction. Dx: with GBS and instructed to go to ER if sx progressed. Pt presented with inability to stand or walk 2' to weakness. (+) numbness in stocking-glove pattern.  Decreased strength in feet, legs, arms and hands. Admited for ascending paralysis. Tx with plasmapheresis with some improvement in neuro fxn noted. D/C to rehab. 1/21/2010 Still disabled, recoverd some function.				Y	Y	150	Y	Y	N	10/09/2007	10/12/2007	3	WBC: 12.6, HGB 12.9 HCT 39.1 PLT 452 Na 128 K 2.9 Cl 86 C02 28 BUN 28 glu 174. Labs and Diagnostics: Head CT normal.  EEG normal.  CT lumbar spine: DDD L3-S1. CXR WNL.  MRI thoracic and lumbar: normal thoracic, with lumbar DDD.  CSF cytology (-) for malignancy.  CSF glucose 86, CSF protein 130.7. CSF WBCs 6.  CSF 0 Oligoclonal bands. Myelin basic Protein WNL.  CSF IgG 20.3 (h). CSF IgG Synthesis high +29.0. CSF albumin 77.6 ESR 39. Vit B12 972 (h). CK 638 down to 33 by 10/20/07.  CK-MB 17.2. Troponin 0.12.  Lyme (-). Culture R eye (+) Staph aureus. UC (-).  CSF cx (-). Electrolytes low. Glucose high	MIL	MIL		Nifedipine (Eqv-cc) 60 mg SA tab l tab by mouth each day; Atenolol 50 mg daily; Dyazide 37.5/s5 mg every other day; glucosamine/msm; fish oil bid; mvi; red yeast rice capsule	allergies:  cat hair; zocur-fluvastatin. PMH: Prostate CA, Aortic Valve Stenosis, diverticulosis, HTN, high cholesterol. Allergy to dairy.			1						1	Abasia; Activities of daily living impaired; Albumin CSF increased; Ataxia; Blood chloride decreased; Blood creatine phosphokinase abnormal; Blood glucose increased; Blood potassium decreased; Blood sodium decreased; Blood urea increased; Carbon dioxide normal; Chills; Coordination abnormal; Diarrhoea; Guillain-Barre syndrome; Haemoglobin decreased; Intervertebral disc degeneration; Loss of proprioception; Muscular weakness; Plasmapheresis; Platelet count increased; Pyrexia; Sensory loss; Walking aid user; Wheelchair user; White blood cell count increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80685~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0310146	04/18/2008	PA	18.0	18		F	04/07/2008	Started with a headache.  Developed fatigue and achiness.  Fever, chills, increased heart rate, pallor.  Temperature max 103 F, lasted 2-3 days.									Y	03/31/2008	04/01/2008	1	None	PUB	UNK		None	None			1						1	Chills; Fatigue; Headache; Heart rate increased; Pain; Pallor; Pyrexia	FLU3~SANOFI PASTEUR~U2475KA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1417U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0310376	04/21/2008	IN	58.0	58		F	04/21/2008	L upper arm pain starting a few days after a flu shot, spread up to shoulder.  Pt. unable to lift shoulder or reach back without pain.  Came to office for evaluation on 4/9/08.  Evaluation at that time felt to be consistent with adhesive capsulitis and patient referred to orthopedic surgeon.									N	10/08/2007	10/10/2007	2	none	PVT	PVT	Levoxyl, vitamin C, Naprosyn, multiple vitamin	no	penicillin, possibly Bactrim			1						1	Joint range of motion decreased; Pain in extremity; Periarthritis	FLU3~SANOFI PASTEUR~U2445AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0310379	04/21/2008	WI	6.0	6		F	04/21/2008	After immunizing for Hep A, child developed strep throat.  1st dose Dx 4 days later.  2nd dose Dx 3 days later.									Y	11/16/2007			Rapid strep screen	PVT	PVT	triamcinolone 0.1% ointment	none	atopic dermatitis	strep~Hep A (no brand name)~1~0.00~In Patient		1						1	Pharyngitis streptococcal; Streptococcal identification test	FLU3~SANOFI PASTEUR~U2502AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0310384	04/21/2008		27.0	27		M	03/21/2008	6cm x 8cm area of erythema over right deltoid.  Complaints of pruritis.  Treated with Benadryl 50mg po q 6hr.									Y	03/17/2008	03/17/2008	0		MIL	MIL	None	None	None			1						1	Erythema; Pruritus	ANTH~EMERGENT BIOSOLUTIONS~FAV176~5~SC~RA~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500534P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|JEV~SANOFI PASTEUR~EJN230M~3~SC~RA~JAPANESE ENCEPHALITIS (JE-VAX)~1	USA		Influenza
0310519	04/22/2008	AZ	1.2	1	.2	M	04/16/2008	None Stated									U	10/18/2007	04/14/2008	179		PVT	PUB		none	none			1						1	Inappropriate schedule of drug administration; Unevaluable event	DTAP~SANOFI PASTEUR~C2657AA~4~UN~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT2459KA~4~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0003U~3~UN~RA~HIB + HEP B (COMVAX)~1|HEPA~SMITHKLINE BEECHAM~AHAV181AA~1~UN~LA~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0413U~1~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B26584F~4~UN~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0310524	04/22/2008	NJ	76.0	76		F	03/26/2008	Pain subsequent to injection in right upper extremity in area of lower deltoid Dull to severe ache worse with use. 1st reported on 10-23-07. Unresponsive to Advil, Tylenol, Lipoderm patch, Neurontin and Capsaicin cream.									N	10/09/2007	10/23/2007	14	EMG no nerve damage; RUE WNL. MRI - right upper extremity. N.E.D. (Muscle); ESR - 2	PVT	PVT	Premarin 0.3; Calcium D; Vit C	traumatic contusion				1						1	Electromyogram normal; Injected limb mobility decreased; Injection site pain; Nuclear magnetic resonance imaging normal; Pain; Pain in extremity; Red blood cell sedimentation rate decreased	FLU3~SANOFI PASTEUR~U2451AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~UNKNOWN MANUFACTURER~U1907AA~UNK~UN~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0310573	04/22/2008	CA	3.0	3		F	04/22/2008	Swollen area to Left thigh area, now 12 days post vaccination with DTAP #4, Flu #1 to that leg.										04/10/2008	04/12/2008	2		UNK	UNK	None	No		None~ ()~~0.00~In Patient		1						1	Injection site swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14BO73AA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2508AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0310732	04/23/2008	MA	69.0	69		M	04/23/2008	Central nervous system demylination 7 days after flu vaccine that led to cortical blindness.  Pathology confirmed demyelination.  5/23/08 Reviewed hospital medical records of 11/13-11/26/2007. FINAL DX: ADEM secondary to flu vaccine Records reveal patient experienced blurry vision 10/18, then lost vision on right side, then bilateral vision loss x 3 days.  Saw PCP 10/23 & had head CT scan done which revealed old infarcts.  Admitted to outlying hospital for w/u which was c/w ischemic stroke, tx & d/c to home.  Was stable until 11/9/07 when again had blurry vision which progressed to vision loss, perceiving only bright light.  Returned to outlying ER & transferred to higher level of care.  Tx w/high dose steroids w/o improvement.  Surgical biopsy done which showed inflammatory white matter disease c/w demyelination.  Additional steroids given w/o improvement. D/C to home w/outpatient therapy.			Y	Y	Y	7		Y	N	10/11/2007	10/18/2007	7	MRI   LP  Blood tests CT scan  LABS: CSF glucose 63(N), protein 59.1 (H), c/s neg[[address]]head all abnormal.  Repeat MRI brain 4/4/08 showed improvement in ADEM w/residual abnormality suggestive of gliosis & unchanged encephalomalacia & [[name]] matter injury.  MRI spine 4/4/08 abnormal. Outlying hospital LABS: MRI brain, both acute & old infarcts.  MRA of head WNL.  Echocardiogram WNL.	UNK	UNK			Hypertension, hyperlipidemia, prior stroke in 1984, for which he was on Coumadin for 15 years.  PMH: HTN, hyperlipidemia, CVA x 2 w/residual left side weakness, essential tremor, right lung empyema, diverticulitis, DJD, BPH.  Ex-smoker.  Uses ETOH	demyelination~Influenza (Seasonal) (no brand name)~1~69.00~Patient		1						1	Blindness cortical; Demyelination; Lumbar puncture	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0310750	04/23/2008	OR	86.0	86		F	04/21/2008	Patient says area of upper left arm has been bothering her since time of vaccine.  She says it is 3x6 area and is annoying.  Not constant pain deep in arm.  No redness or swelling.  (*Note: patient did not call for 7 months).									U	10/15/2007	10/16/2007	1	None	OTH	PVT		None	No info on file.			1						1	Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80682~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0310752	04/23/2008	CA	29.0	29		F	04/22/2008	104 degree fever; aches; rapid heartbeat; hives all over body; wheezing; ER visit; IV, Benadryl injection; 3 weeks of prednisone; ongoing antihistamine regimen.				Y					Y	03/21/2008	03/22/2008	1	blood/urine - normal; chest X-ray - normal; heart rate - 133; fever 104 degrees	PVT	OTH	Ortho Cyclen	NONE	NONE			1						1	Blood test normal; Chest X-ray normal; Heart rate increased; Pain; Pyrexia; Urine analysis normal; Urticaria; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA310AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0310755	04/23/2008	CA	4.0	4		F	04/23/2008	Redness & swelling on arm at site of DTaP administration.  Swelling started within 1 hour of vaccine & has been stable for 2 days.				Y					U	04/21/2008	04/21/2008	0		PUB	PUB	none	none	none			1						1	Injection site erythema; Injection site swelling	DTAP~SANOFI PASTEUR~U1965AB~5~UN~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2512AA~3~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A03422~4~UN~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1747U~2~UN~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0310800	04/24/2008	ME	4.0	4		M	04/21/2008	Exanthem with crusted papules on torso -> extrom - 1-2 dozen lesions, pruritic, increased past 2d.									U	11/05/2007				PUB	PUB		None	No			1						1	Pruritus; Rash; Rash papular; Scab	DTAP~SANOFI PASTEUR~C2749AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2438AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0797U~1~IM~LA~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~A01692~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~0074U~2~SC~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0310805	04/24/2008	MD	56.0	56		F	04/21/2008	Persistent left arm pain at site of vaccination. Pain has lasted 6 months. 6/11/08-records received for DOS 10/29/07-6/2/08-on date of vaccine C/O 3 days of nasal congestion, fatigue, chills/sweats and cough. DX:pharyngitis. URI/asthma.11/7/07, 11/19/07, 11/28/07, 12/5/07,12/19/07, 1/2/08,1/16/08-Follow-up for persistent cough. Unable to work, wheezing, cough keeps her up at night, myalgia, sinusitis, new onset of type 2 diabetes mellitus. 3/12/08 first complaint of left arm pain status post pneumovax. Unable to work due to wheezing retired from job 1/16/08. 6/2/08-cough continues, unable to life arm overhead. Left shoulder pain. Follow-up: Left shoulder pain persists - unclear if this pain is related to the PNEUMOVAX. Left arm pain has resolved.								Y	N	10/29/2007	10/29/2007	0		PVT	PVT	Verapamil; HCTZ; Amitriptyline; Singulair; Proventil; Advair; Lyrica; Spiriva; Glucophage; Prilosec; Atrovent; Lisinopril; Nasonex; Naprosyn	upper respiratory infection; asthma exacerbation	Allergy to penicillin, hay fever, asthma, HTN, fibromyalgia, DM Type 2			1						1	Injection site pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80683~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0554U~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0310822	04/24/2008	MA	66.0	66		M	02/05/2008	Went to ER 2 days after receiving vaccine, with soreness, redness and swelling of (R) arm. Swelling from deltoid to elbow. Treated with antibiotics.				Y					Y	11/17/2007	11/18/2007	1	Blood tests	PUB	PUB	Lipitor; Enalapril; Hydrochlorothiazide; Celebrex; Diazepam; Dicrofin		Hypertension, Chronic Bronchitis, Asthma		MA0806	1						1	Blood test; Injection site erythema; Injection site pain; Injection site swelling; Oedema peripheral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA050AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0964U~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0310848	04/24/2008	OK	38.0	38		M	04/24/2008	On Sun. 11/11/07 in the morning started having pains in tops of feet, then progressed to soles of feet, then up calves to backs of thighs.  Continues to have pain in legs, esp. knees and legs feel very fatigued which is making it difficult for him to work.  He has had back pain before this so Dr. ordered MRI of back.  Saw Neurosurgeon who told him he could not see any reason for his leg problems or his back pain. Had to quit his job due to pain in legs.									N	11/01/2007	11/11/2007	10	MRI back, labs (do not know what they were or results	UNK	UNK	Ibuprofen	none	Horse Serum	cellulitis~DTP (no brand name)~2~2.00~Patient|cellulitis~DTP (no brand name)~1~7.00~Sibling		1						1	Back pain; Impaired work ability; Laboratory test; Muscle fatigue; Nuclear magnetic resonance imaging; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80822~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0311949	04/24/2008	SC				U	04/11/2008	This case was reported by a healthcare professional via a sales representative and described the occurrence of extensive swelling of vaccinated limb in multiple subjects of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date between the end of November 2007 until 18 January 2008 the subject received unspecified dose of FLULAVAL (.5 ml, unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced swelling of vaccinated limb that was described as severe arm swelling at injection site with redness, injection site redness, unspecified adverse reactions and pharmaceutical product complaint. At the time of reporting the outcome of the extensive swelling of the vaccinated limb, injection site redness and unspecified adverse reactions were unspecified. Per the source document it was also noted that multiple patients report adverse reactions to immunization. It was also noted that the FLULAVAL had not been compromised and had been stored properly. The report questioned if issues with this lot number had been reported by other facilities or was her facility the only one. Lot number AFLLA032AA									U				UNK	OTH	OTH		Unknown	Per the source document it was noted that multiple patients report adverse reactions to immunization. The reporter stated that another subject experienced an adverse event. Details of this are found in GSK manufacturer number A0704660A.		A0705208A	1						1	Injection site erythema; Injection site swelling; Pharmaceutical product complaint; Vaccination complication	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA032AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0311950	04/24/2008	SC				U	04/11/2008	This case was reported by a healthcare professional via a sales representative and described the occurrence of unspecified adverse event in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown) from lot number AFLL032AA. The sales representative reported the lot number to be AFL1A032AA but reported that he was unsure if the fourth character was a 1 of L. At an unspecified time after vaccination with FLULAVAL, the subject experienced adverse event event and pharmaceutical product complaint. At the time of reporting the outcome of the unspecified adverse event was unspecified. Per the source document it was reported that the nurse questioned if there were any hot lots. The nurse reported that she was not going to use any more FLULAVAL. It was noted that this was a legal case. The nurse reported that this event occurred in two other subjects. See GSK manufacturer case number A0705244A and A0705245A for details.									U				UNK	OTH	OTH		unknown	The reporter stated that this event occurred in two other subjects. See GSK manufacturer case number A0705244A and A0705245A for details of the other two subjects.		A0705222A	1						1	Pharmaceutical product complaint; Vaccination complication	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA032AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0311952	04/24/2008	SC				U	04/11/2008	This case was reported by a healthcare professional via a sales representative and described the occurrence of unspecified adverse event in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown) from lot number AFLL032AA. The sales representative reported the lot number to be AFL1A032AA but reported that he was unsure if the fourth character was a 1 or L. At an unspecified time after vaccination with FLULAVAL, the subject experienced unspecified adverse event and pharmaceutical product complaint. At the time of reporting the outcome of the unspecified adverse event was unspecified. Per the source document it was reported that the nurse questioned if there were any hot lots. The nurse reported that she was not going to use any more FLULAVAL. It was noted that this was a legal case. The nurse reported that this event occurred in two other subjects. See GSK manufacturer case number A0705222A and A0705245A for details.									U				UNK	OTH	OTH		Unknown	The reporter stated that this event occurred in two other subjects. See GSK manufacturer case number A0705222A and A0705245A for details of the other two subjects.		A0705244A	1						1	Pharmaceutical product complaint; Vaccination complication	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA032AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0311955	04/24/2008	SC				U	04/11/2008	This case was reported by a healthcare professional via a sales representative and described the occurrence of unspecified adverse event in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown) from lot number AFLL032AA. The sales representative reported the lot number to be AFL1A032AA but reported that he was unsure if the fourth character was a 1 or L. At an unspecified time after vaccination with FLULAVAL, the subject experienced unspecified adverse event and pharmaceutical product complaint. At the time of reporting the outcome of the event unspecified adverse event was unspecified. Per the source document it was reported that the nurse questioned if there were any hot lots. The nurse reported that this event occurred in two other subjects. See GSK manufacturer case number A0705222A and A0705244A for details.									U				UNK	OTH	OTH		Unknown	The reporter stated that this event occurred in tow other subjects. See GSK manufacturer		A0705245A	1						1	Pharmaceutical product complaint; Vaccination complication	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA032AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0311957	04/24/2008					F	04/11/2008	This case was reported by a healthcare professional, who was also the vaccination subject, that described the occurrence of arm soreness in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 20 October 2007, the subject received an unspecified dose of FLULAVAL (unknown, left deltoid). On 20 October 2007, less than one day after vaccination with FLULAVAL, the subject experienced arm soreness and arm weakness. The reporting healthcare professional/subject reported that she has experienced left arm soreness and weakness since receiving the FLULAVAL vaccine. At the time of reporting the events were unresolved.									N	10/20/2007	10/20/2007	0	UNK	PUB	OTH		Unknown	The reporting healthcare professional was also the vaccination subject. The healthcare professional/patient is a Certified Medical Assistant at a hospital and wished to remain anonymous. The subject stated that she received the FLULAVAL vaccine at her employee health clinic, but she had not reported the adverse events to her primary healthcare provider. The reporter declined to provide any further information.		A0707533A	1						1	Limb discomfort; Muscular weakness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLL031AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0311958	04/24/2008	FL	59.0	59		F	04/11/2008	This case was reported by a healthcare professional and described the occurrence of upper respiratory symptoms in a 60-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included seasonal allergy and sinusitis. Concurrent medications included SYNTHROID, ATENOLOL, ZYRTEC, BEXTRA and NASONEX. On 24 October 2007 the subject received a dose of FLULAVAL at 0.5 ml in the right arm. In December 2007, after vaccination with FLULAVAL, the subject experienced upper respiratory symptoms, sinusitis and bronchitis. In January 2008, with continued symptoms, the subject had a quanitative blood test where she tested positive for influenza A and B. The subject experienced a systemic reaction. At the time of reporting the events were unresolved. Follow-up information was received on 14 March 2008, via healthcare professional, who reported the events had resolved. The healthcare professional clarified that the laboratory results reflected a positive titer for influenza A and B and the patient had not necessarily contracted influenza. The reporting healthcare professional considered the events possibly related to vaccination with FLULAVAL.									Y	10/24/2007			A quanitative blood test performed in January 2008 revealed that the subject was positive for Influenza A and B.	PUB	PVT	Thyroxine sodium; Atenolol; Cetirizine hydrochloride; Bextra;Mometasone furoate	SEASONAL ALLERGY, SINUSITIS	The subject has previously received flu shots and no reactions were noted. The subject has no history of adverse events following previous vaccinations. Follow-up information was received on 14 March 2008. The subject had previously received an influenza vaccination in 2006. It was unknown if the subject had adverse events following the vaccination.		A0707921A	1						1	Bronchitis; Influenza serology positive; Sinusitis; Upper respiratory tract infection	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA029AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0311960	04/24/2008					U	04/11/2008	This case was reported by a healthcare professional and described the occurrence of influenza in two to three subjects of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). The reporter did not have the specific number of subjects or demographics for these subjects. On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced influenza A and vaccination failure. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.									U				UNK	OTH	OTH		Unknown	The nurse commented that 2-3 patients who received FLULAVAL in the Fall tested positive for influenza A antigen in the last week or two. She did not have the specific number of subjects or demographics for these subjects but did state they received FLULAVAL from the same lot number as the subject of case A0711044A who also experienced influenza A. She also reported that over the years she had seen subjects develop the flu even after receiving the flu vaccine she had no specifics on these subjects nor which vaccine they received. See GSK case number A0711172A for details.		A0711167A	1						1	Influenza; Vaccination failure	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA024AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0311962	04/24/2008	MN				F	04/11/2008	This case was reported by a healthcare professional and described the occurrence of positive influenza B cultures in a female subject aged between 80 and 89 old who was vaccinated with FLULAVAL (GlaxoSmithKline). In October 2007 the subject received unspecified dose of FLULAVAL at 0.5 ml. On 26 February 2008, several months after vaccination with FLULAVAL, the subject experienced positive B influenza cultures. A nasal culture was done. The subject was diagnosed with influenza B. The strain of the B was not known. At the time of reporting the outcome of the events was unspecified. This event occurred in two different subjects with the master being this case and the other with number A0713052A.									U		02/26/2008		A nasal culture performed on an unspecified date was positive for B influenza.	OTH	OTH		Unknown	The subject is a nursing home resident. This event occurred in two different subjects with the master being this case and the other with number A0713052A.		A0713041A	1						1	Influenza; Influenza serology positive; Virus culture positive	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA052AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0311965	04/24/2008	MN				F	04/11/2008	This case was reported by a healthcare professional and described the occurrence of positive influenza B cultures in a female subject aged between 80 and 89 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). In October 2007 the subject received unspecified dose of FLULAVAL at 0.5 ml. On 26 February 2008, several months after vaccination with FLULAVAL, the subject experienced positive B influenza cultures. A nasal culture was done. The subject was diagnosed with influenza B. The strain of the B was not known. At the time of reporting the outcome of the events was unspecified. This event occurred in two different subjects with the master case being case number A0713041A.									U		02/26/2008		A nasal culture performed on an unspecified date was positive for B influenza.	OTH	OTH		Unknown	The subject is a nursing home resident. This event occurred in two different subjects with the master case being case number A0713041A.		A0713052A	1						1	Influenza; Influenza serology positive; Virus culture positive	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA052AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0311966	04/24/2008	AL	67.0	67		M	04/11/2008	This case was reported by a healthcare professional and described the occurrence of insomnia in a 67-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 03 January 2008, the subject received unspecified dose of FLULAVAL (.5 ml, unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced insomnia. According to the reporter, the subject was referred to a sleep specialist. At the time of reporting the event was unresolved.									N	01/03/2008	01/03/2008	0	UNK	OTH	OTH		Unknown	The subject's medical history, concomitant medications, and history of adverse events following previous vaccinations were not reported.		A0719436A	1						1	Insomnia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLLA058AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0310914	04/25/2008	NY	13.0	13		F	04/23/2008	Information has been received from a physician concerning a 14 year old female with asthma and no drug allergies, who in November 2007 was vaccinated with a first dose of GARDASIL.  There was no concomitant medication.  Subsequently, two or three weeks post vaccination the patient developed an enlarged spleen, swollen liver, high liver enzymes, swollen eye lids, weight loss, difficulty urinating, fever, fatigue, joint pain, and swollen glands.  The patient had been out of school and was hospitalized for approximately one week.  The following tests were performed: mononucleosis, lupus, rheumatoid arthritis, hepatitis, lime disease, and many other lab tests.  At the time of the report the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.  5/19/2008 MR received for DOS 3/4-8/2008 with D/C DX: Viral Syndrome.  Pt presented to ER with 5 day hx of fevers, difficulty urinating, fatigue, abdominal and flank pain as well as eyelid swelling. Pt reports knee, elbow and joint pain. PE (+) for periorbital swelling and abdominal tenderness. Tx with ceftriaxone.					Y	5			N	11/01/2007	11/01/2007	0	Diagnostic laboratory test for lupus; diagnostic laboratory test for hepatitis; diagnostic laboratory many other tests; serum Epstein-Barr; Lyme disease assay; serum rheumatoid factor[[address]]Labs and Diagnostics:  CT and US abdomen (+) spleen enlargement. US spleen (+) splenomegaly.  CBC unremarkable. Chem WNL except total bili 2.3. CMV IgG/IgM (-). EBV IgG/IgM (-). UA with protein 30, moderate blood, trace WBCs, occ bacteria and epis. Blood cx (-). UC-no pathogens[[address]]	OTH	OTH	None	Asthma	PMH: asthma, elbow fracture w/surgery, febrile seizure, ear tube placement		WAES0804USA02880	1						1	Activities of daily living impaired; Arthralgia; Dysuria; Eyelid oedema; Fatigue; Pyrexia; Splenomegaly; Weight decreased	FLUX~UNKNOWN MANUFACTURER~U2476HA~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~1266U~1~UN~UN~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2438AA~UNK~~~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Hospitalisation	Influenza
0310921	04/25/2008	MA	0.51	0	.5	M	04/23/2008	Information has been received from a physician concerning an 8 month old male who on 05-OCT-2007, 01-DEC-2007 and 08-FEB-2008 was vaccinated PO with his first, second and third standard doses of Rotateq.  Concomitant vaccinations included other routine vaccines.  Subsequently the patient experienced intussusception went to an emergency room and was subsequently hospitalized.  The patient had surgery on 14-APR-2008.  Subsequently, the patient recovered and was discharged from the hospital.  There was no product quality complaint.  Intussusception was also considered to be an other important medical event (surgery) by the physician.  Additional information has been requested. 8/11/08-records received for DOS 3/26-3/29/08-DC DX: Intussusception. Leukocytosis. Presented to ED with screaming, vomiting and difficulty breathing, abdominal pain, inconsolable. Last BM day before. Exploratory laparotomy with incidental appendectomy.				Y	Y	3			Y	02/08/2008	03/26/2008	47	Unknown 8/11/08-records received-BE performed times 3 unsuccessful reduction of intussusception. WBC 19.40, lymphocyte % 40.0. Alk Phos 325, AST 351, ALT 41.	OTH	OTH			Unknown		WAES0804USA04007	1						1	Intussusception; Intussusception	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A127AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2523AA~1~ID~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~VF119AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B26510D~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1129V~3~PO~MO~ROTAVIRUS (ROTATEQ)~1|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B127AA~3~UN~LL~DTAP + HEPB + IPV (PEDIARIX)~2|FLU3~SANOFI PASTEUR~U2523AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~SANOFI PASTEUR~UF119AA~3~UN~RL~HIB (ACTHIB)~2|PNC~PFIZER\WYETH~B26510D~3~UN~RL~PNEUMO (PREVNAR)~2|RV5~MERCK & CO. INC.~1129U~3~PO~MO~ROTAVIRUS (ROTATEQ)~2	USA	Hospitalisation	Influenza
0299459	04/28/2008	MD				F	11/28/2007	This case was reported by a health professional on 04 September 2007.  A female patient with no reported medical history received injections of DECAVAC, FLUZONE, IPOL, MENOMUNE, TYPHIM VI, and HAVRIX (manufacturers and lot numbers not reported) on 20 December 2006.  Almost immediately, the patient reported that she experienced dark circles under my eyes, bags under my eyes, a permanent tired line in my face, and hair loss.  Per the reporter, the events were ongoing.  Follow-up information received on 26 November 2007 from a health care professional.  The reporter provided the following information concerning the vaccines administered.  DECAVAC, lot number U1880DA was administered in the left deltoid; MENACTRA, lot number U2135AA, was administered in the left deltoid; IPOL, lot number Z0306, was administered in the right arm; FLUZONE, lot number ASLUA203BA, (not a valid sanofi pasteur lot number), was administered in the right deltoid; TYPHIM VI, lot number Z0572, was administered in the right deltoid; and HAVRIX, manufacturer GSK, lot number AHAVB109, was administered in the right deltoid.  Contact information was provided for the physician who was following the patient.  The reporter indicated that she does not know if the patient had recovered and that she does not have additional information to provide regarding this case.  The patient's husband also reported experiencing dark circles under eyes, bags under eyes, and a permanent tired line in the face after receiving the above vaccines; this information is captured in case number 2007-02806.									U	12/20/2006				UNK	UNK					200703017	1						2	Alopecia; Dark circles under eyes; Skin wrinkling	FLUX~UNKNOWN MANUFACTURER~ASLUA203BA~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB109~UNK~UN~RA~HEP A (HAVRIX)~2|IPV~SANOFI PASTEUR~Z0306~UNK~UN~RA~POLIO VIRUS, INACT. (IPOL)~2|MNQ~SANOFI PASTEUR~U2135A~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TD~SANOFI PASTEUR~U1880U~UNK~UN~UN~TD ADSORBED (NO BRAND NAME)~2|TYP~SANOFI PASTEUR~Z0572~UNK~UN~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~2	USA		Influenza
0311042	04/28/2008	PA	1.6	1	.6	M	04/21/2008	Received 18 mo. immunization on 11/20/06 including DTaP and IPV. 3 days later, pt. had fever and concurrent seizure. Since that time, pt. has had recurrent seizures and is now on medication. Pertussis for 1st reaction/seizure or decreased seizure threshold.				Y					N	11/20/2006	11/23/2006	3	EEG/CT	PVT	UNK	None	None	None			1						1	Computerised tomogram; Convulsion; Electroencephalogram; Pyrexia	DTAP~UNKNOWN MANUFACTURER~~4~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~~2~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~UNKNOWN MANUFACTURER~~3~UN~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0311045	04/28/2008	NY	6.0	6		F	10/26/2007	Redness, induration, subcutaneous inflammation of both ankles. Extention to feet and lower areas or both calves. Mild/moderate intensity redness, induration, hematomas resolved after 2 weeks treatment: Benadryl 12.5 mg TID, Orapred 22.5 mg qd/5 day									Y	10/12/2007	10/20/2007	8	None	PVT	UNK		None		~Hep A (Havrix)~1~16.00~In Patient		1						1	Erythema; Haematoma; Induration; Inflammation	FLU3~SANOFI PASTEUR~U2490AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~04954~2~IM~UN~HEP A (VAQTA)~1	USA		Influenza
0311046	04/28/2008	NE	4.0	4		M	01/11/2008	Left anterior thigh red, swollen, warm to most of anterior thigh with parts of lateral and medial thigh.				Y					U	01/09/2008	01/10/2008	1	None	OTH	PUB		None	Healthy child			1						1	Injection site erythema; Injection site swelling; Injection site warmth	DTAP~SANOFI PASTEUR~C2760AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2435AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0125~4~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~0425U~2~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Emergency room visit	Influenza
0311198	04/29/2008	TX	62.0	62		M	04/28/2008	11/26/07 Seen by PCP-for headache with watery eyes, skin rash. 11/27/07 weakness in facial and lip area, (L) eye would not shut. 12/3/07 Headache, insomnia, 12/7/07 weakness, earache, 12/10/07 weakness, 12/14/07 weakness; 1/4/08 weakness; 2/4/08 Idiopathic peripheral neuropathy 5/7/08-records received for DOS 12/14-12/21/07-DC DX: Guillain-Barre syndrome. Onset of left side of face Bell's palsy on 11/25/07. Day before experienced bifrontal headache. Two weeks ago experienced weakness of lower extremities and became progressive to point he could no longer ambulate. Difficult time standing from sitting . Now has mild weakness in upper extremities. Paresthesias of all four extremities. Fell recently. DTRs absent throughout. Lumbar puncture unremarkable. IVIG treatment.				Y	Y	7			U	11/14/2007	11/25/2007	11	CT scan, LAB, MRI brain; MRI Lumbar Spine; Internal Med. Referral 5/7/08-records received-. MRI L-spine moderate diffuse degenerative disc disease. MRI brain mild ischemic matter findings in periventricular regions. CT brain, mild atrophy.	OTH	MIL	Lisinopril 40 mg daily; ASA 81 mg; Prilosec 20 mg daily; HCTZ 25 mg daily	None	Hypertension; GERD 5/7/08-records received-PMH: hypertension. Obesity. Gastroesophageal reflux disease			1						1	Ear pain; Eye movement disorder; Facial paresis; Headache; Insomnia; Laboratory test; Lacrimation increased; Neuropathy peripheral; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA049AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation	Influenza
0311274	04/30/2008	MO	46.0	46		F	04/20/2008	Hearing loss in left ear; dizziness; tinnitus. Doctor prescribed Afrin and Flonase sprays at separate times. Tinnitus and hearting loss started on 10/14/07 to present.  5/9/08 Reviewed ENT office notes of 11/28 & 12/19/2007. FINAL DX:left sudden sensorineural hearing loss Records reveal patient experienced decreased hearing since 10/14/07.  Developed vertigo, tinnitus & severe fatigue 4 days later.  Seen by PCP who dx eustachan tube dysfunction.  Tx w/nasal spray, steroids & decongestant w/no improvement.  ENT exam removed cerumen impaction.  Audiometry revealed: right mild sensorineural loss; left mod sensorineural hearing loss.  Referred for MRI, labs & otologist. 6/13/08 Reviewed Otolaryngology Clinic Notes of 1/3/2008. FINAL DX: sudden sensorineural hearing loss Records reveal patient experienced sudden hearing loss 10/2007 followed 2 days later w/lightheadedness that resolved in a few hours & tinnitus.  Hearing had improved only slightly & hearing aid recommended. 1/21/2010 Hearing loss in left ear.				Y				Y	N	10/08/2007	10/14/2007	6	MRI and blood test performed per ENT Doctor. All were negative; Audiology test done - and showed hearing loss in left ear.   LABS: MRI revealed pansinusitis.	PUB	OTH	Sudafed; Benadryl; Vitamins; Tums	No	Alpha Thalassemia minor; Hay fever - received allergy shot 9/19/07; Scoliosis  PMH: borderline asthmatic, eczema.  Had received multiple vaccinations for foreign travel 3 yrs prior. allergic erythromycin & sulfa.			1						1	Audiogram abnormal; Blood test normal; Deafness unilateral; Dizziness; Tinnitus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ASLUA294DA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Disabling	Influenza
0311326	04/30/2008	TX	59.0	59		F	10/22/2007	Evening after receiving vaccine, noticed burring and itching of skin.  Worsened daily to include rash on arms, face, stomach, legs and back.  Sought treatment from family doctor 8 days after vaccination.  Treated with oral corticosteroids and diphenhydramine.  Rash resolved.				Y					Y	10/10/2007	10/10/2007	0	None	UNK	UNK	NONE	NONE	PENICILLIN AND ASPIRIN ALLERGY			1						1	Pruritus; Rash generalised; Skin burning sensation	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA067AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0311353	04/30/2008	MA	32.0	32		F	04/22/2008	A serious report of a medically important event of spontaneous abortion in a 32-year-old pregnant woman who was administered FluMist was received from a nurse practitioner. No medical history nor concomitant medications were reported. The patient was in a shelter for the homeless. The patient received FluMist on 12-Nov-2007. At the time of FluMist administration, the patient denied pregnancy or any other contraindication. On 16-Nov-2007, the patient notified the reporter that she was pregnant and in the first trimester of her pregnancy. The pregnancy was confirmed by urine test on an unreported date. In December 2007, the patient experienced bleeding and when examined by an obstetrician-gynecologist (OB-GYN), it was determined that the pregnancy was non-viabe and the patient had experienced a spontaneous abortion. No causality assessment was reported for the pregnancy. The reporter stated that the patient's OB-GYN did not think that the spontaneous abortion was related to FluMist vaccine. The sponsor considered the spontaneous abortion an important medical event.									Y	11/12/2007	11/12/2007	0		OTH	OTH	Concomitant Drug Not Reported				MEDI0006198	1						1	Abortion spontaneous; Drug exposure during pregnancy; Pregnancy test urine positive; Vaginal haemorrhage	FLUN3~MEDIMMUNE VACCINES, INC.~530436P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0311356	04/30/2008	TN	0.5	0	.5	M		None									Y	01/29/2008				PVT	PUB						1						1	Inappropriate schedule of drug administration; No adverse event	DTAPH~SANOFI PASTEUR~~UNK~UN~RL~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~UL531AA~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A02982~UNK~UN~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~870145C~UNK~UN~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1244U~UNK~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0311361	04/30/2008	TN	0.5	0	.5	F		No Adverse Event									Y	02/11/2008				PVT	PUB						1						1	Inappropriate schedule of drug administration; No adverse event	DTAPH~SANOFI PASTEUR~~UNK~~~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~~UNK~~~HEP B (RECOMBIVAX HB)~1|IPV~SANOFI PASTEUR~~UNK~~~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~~UNK~~~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~~UNK~~~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0311368	04/30/2008	CA	45.0	45		F		Patient returned to pharmacy 4/18/08 stating that her shoulder was hurting as a result of vaccination given 12/31/07.  Vaccine provider was not present.  Patient won't return calls.  No other information.									U	12/31/2007			None	OTH	PVT	None known	None	None			1						1	Musculoskeletal pain	FLU3~SANOFI PASTEUR~U2488AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0216579	05/01/2008	MD	39.0	39		F	05/01/2008	13 sterile abscesses from injection. Tumor in breast from vaccine. Trigger Point injections- 6 months. Electic shock treatments - memory loss. Allegra- for life... to keep side affects in check and pain managed. 1/25/2010 Follow-up: My arm hurts constantly. I have nerve damage, my back hurts and the site of injection gets red and inflamed and the hole opens where the needle went in and it weeps fluids. I have 13 very small sterile abscess in my arm and a tumor in my breast because of the vaccine.				Y				Y	N	11/22/2001	11/22/2001	0	Suffered a head attack 20 minutes after the injection of the vaccine. Developed rash, flu like symptoms, delirium, fever- emergency room admittance.	UNK	UNK						1						2	Amnesia; Breast mass; Delirium; Electric shock; Headache; Influenza like illness; Injection site abscess sterile; Injection site erythema; Injection site inflammation; Nerve injury; Pain in extremity; Pyrexia; Rash	FLU3~SANOFI PASTEUR~?~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Disabling	Influenza
0311412	05/01/2008	NY	1.5	1	.5	M	05/01/2008	Erythema multiforme recurring for 6 weeks. 2 er visits and 4 pediatrician visits. 2 visits to dermatologist. child was treated with repeated doses of prednisolone 3 times. I have asked pediatricians office twicw to report and document this and have gotten no response from them. the dermatologist has noted in his report that there is correlation between the Em dx and the vaccinations.				Y					U	10/26/2007	12/01/2007	36	tested for guillen barr and strep along with other blood and urine test at er. all negative	PVT	UNK		none- last ilness was at between 12-15 months	none			1						1	Blood test normal; Erythema multiforme; Laboratory test normal; Streptococcal identification test negative; Urine analysis normal	DTAP~SANOFI PASTEUR~spc2655aa 11/08~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~sput2460ga 06/0~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0311471	05/02/2008	PA	55.0	55		M	02/15/2008	8 days after Flu shot-Vertigo, tinnitus, labyrinitis. 11 days-complete hearing loss of left ear. 40% of right ear to date severe vertigo, tinnitus, labyrinitis prescribed antivert 25 mg  6/3/08 Reviewed PCP medical records of 11/30/2007-4/1/2008 which included ENT & neuro consults.   FINAL DX: sudden severe-to-profound sensory hearing loss. Records reveal this was first flu vaccine patient had ever received.  Experienced dizziness, lightheadedness, fatigue, tinnitus, vertigo, nausea, fever, chills, ears blocked, hearing loss, loss of balance, difficulty walking.  Unable to work.  Dx w/viral labyrinthitis or vestibular neuronitis.  Sent to ER for eval.  Tx w/steroids w/o improvement.  Continued severe hearing losson left, partial hearing loss on right; hyperacusis.  Developed anxiety & depression r/t health & inability to work..  ENT eval x 2, Neuro eval & ID eval.  Left pupil unequal & dx w/iritis. 1/21/2010 Severe hearing loss. 100% left ear, 52% right ear severe vertigo, Tinnitis, scalp lesions, left side Facial Nerve Pain, joint pain.  Since this event, it has left me permanently disabled, mainly due to tinnitus, vertigo and extreme pressure changes. The vestibular nerve in the left; is permanently damaged causing extreme tinnitus. Also, skin lesions keratosis on scalp which required surgery to remove, only to have 8 more pop-up. This event was diagnosed as direct effects on my immune system.				Y				Y	N	01/19/2007	11/28/2007	313	Hearing, MRI, MRA C scan, all negative to tumors or strokes  LABS: CT head c/w age related changes.  MRI & MRA WNL.  Tympanogram of 12/07 & 1/08 were abnormal & unimproved.  Sed rate 30 (H).	OTH	PVT		None	High Cholesterol 253  PMH: smoker;lumbar spondylosis; COPD; impaired fasting glucose; hyperlipidemia; arthritis Family hx cerebrovascular dx & leukemia.			1						1	Angiogram; Arthralgia; Computerised tomogram normal; Ear discomfort; Facial pain; Hyperkeratosis; Impaired work ability; Intraocular pressure increased; Lesion excision; Nuclear magnetic resonance imaging normal; Skin lesion; Surgery; Tinnitus; Tympanometry; Vertigo	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79897~1~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0311499	05/02/2008	NJ	8.0	8		F	05/02/2008	Child fainted on the chair 30 minutes after receiving IPV,MMR,Varicella,Flu and Mantoux testing.Episode lasted for 1-2 minutes. As per father child was scared of needles. Child was observed in the clinic half hour.Follow up call on 4/22 child was doing well,active and playing complaining of just soreness from the injection site.									Y	04/21/2008	04/21/2008	0		PUB	PUB	none	None	None	N/A~ ()~NULL~~In Patient|N/A~ ()~NULL~~In Sibling1|N/A~ ()~NULL~~In Sibling2		1						1	Fear of needles; Injection site pain; Syncope	FLU3~SANOFI PASTEUR~U2497AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0474~5~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0807U~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0084X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0311650	05/05/2008	CA	4.0	4		M		(L) deltoid area, redness (+) color, (+) dolor.										05/03/2008	05/03/2008	0	None	PUB	PUB		None	None			1						1	Erythema; Pain in extremity	DTAP~SANOFI PASTEUR~C2765AA~4~UN~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2513AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1772U~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0311711	05/06/2008	GA	61.0	61		M	05/01/2008	Vaccines administered 4/29/08, pt called 4/30/08 states having chills - took hot bath 2 Tylenol -> felt better.  Check up 5/1/8 pt states had T 102.9 last night, now down to 100.1.									Y	04/29/2008	04/30/2008	1		PVT	PVT	Protonix		acid reflux			1						1	Body temperature increased; Chills	FLU3~SANOFI PASTEUR~U2501AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0803U~1~UN~UN~PNEUMO (PNEUMOVAX)~1|TYP~SANOFI PASTEUR~A0522~1~UN~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|VARZOS~MERCK & CO. INC.~1874U~1~UN~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0311736	05/06/2008	IL	1.08	1	.1	F	05/06/2008	Approximately 2 weeks after the administration of the flu vaccine, the patient developed eye movements diagnosed as possible mini seizures.  No EEG changes.  No other illness symptoms.  These lasted for about 1 month and stopped completely.  We are unsure if this was due to the vaccine, but it is possible as there was nothiing else to point to.  No tx was needed for these episodes and they have resolved completely.				Y					Y	01/15/2008	01/30/2008	15	No EEG changes	PVT	UNK	None	None	None			1						1	Electroencephalogram normal; Eye movement disorder	FLU3~SANOFI PASTEUR~u2528aa~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0311750	05/06/2008	MD	53.0	53		M	05/06/2008	Pt admitted to hospital with 3 week history of bleeding from mouth, nose, ears and insulin injection sites.  INR found to be 5.0 with Plt count of <5.  Medications prior to admission included aspirin, clopidogrel, and warfarin.  Pt stated he had influenza vaccine 3 weeks prior to admission. 5/21/08-records received for DOS 12/7-12/12/07-DC DX: Idiopathic thrombocytopenic purpura. Coumadin coagulopathy. Presented to ED with bruises on skin and bumps at the insulin injection site 3 days prior to presentation. Bleeding from gums, ears and nose for 3 days. Abdominal soreness for 2-3 months.					Y	5			Y	11/24/2007	12/07/2007	13	Plt increased to 91 and INR decreased to 1.1 five days after admission 5/21/08-records received- PT 46.4, INR 5 and PTT 62.6. Platelets 7000.	UNK	UNK	warfarin, clopidogrel, asa	DM, HTN, CAD s/p stent, CHF, AFib	Levofloxacin->hives 5/21/08-records received-PMH:atrial fibrillation, coronary artery disease with LAD stent placed 5/07, CHF, diabetes, hypertension and obesity. Diastolic dysfunction and ejection fraction of 45%, obstructive sleep apnea, chronic bronchitis, seasonal allergies, diabetic retinitis and neuropathy and right below the knee amputation.			1						1	Ear haemorrhage; Epistaxis; Injection site haemorrhage; International normalised ratio increased; Mouth haemorrhage; Platelet count decreased	FLUX~UNKNOWN MANUFACTURER~unknown~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0311761	05/06/2008	HI	45.0	45		F	05/06/2008	Left deltoid with erythemic area of 4 inches in circumference tender to touch/warm. Fever of 102.4.  c/o:  Malaise, SOB, difficult breathing, difficult ambulating.				Y					N	02/25/2008	02/25/2008	0	Left arm cellulitis s/p vaccination.  Fever.	PUB	PUB		Asthma				1						1	Cellulitis; Dyspnoea; Erythema; Gait disturbance; Malaise; Pyrexia; Skin warm; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~80822~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~6652111010~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0311775	05/07/2008		16.0	16		M	05/07/2008	Subject participated in a non-company sponsored clinical trial at a college.  Report was sent to an agency by one of the investigators, but as the company is not involved in this trial, the report was databased as spontaneous report.  A 16-year-old young man, born on 24 OCT 1991, was vaccinated for the first time with FLUVIRIN, batch-no. 0080685, i.m. into the right deltoid muscle on 17 NOV 2007.  An acute episode of severe abdominal pain localized to the right lower quadrant was reported on 24 DEC 2007.  He was seen in the emergency room where he was afebrile (oral temperature 98.7F), his white blood cell count was normal at 9.500 cells and a CAT scan of the abdomen revealed a possible appendicolith with mild thickening of the appendix.  The patient was taken to the operating room for an appendectomy on 24 DEC 2007.  Histology of specimen revealed mild acute appendicitis.  The subject had an uneventful hospital course and was discharged home on 25 DEC 2007.  The investigator did not see a causal relationship to vaccination with FLUVIRIN.  Medical history: asthma.  Seriousness criterion: hospitalisation.  Causality: unrelated.  Appendicitis was caused by appendicolith and subsequent infection.					Y	1			Y	11/17/2007	12/24/2007	37		OTH	OTH	No other medications	Unknown	Asthma		MA20080765	1						1	Abdominal pain; Appendicectomy; Appendicitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~0080685~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0311873	05/08/2008	CA	4.0	4		F	05/05/2008	LD area red, swollen and warm.  X3 days.									Y	05/01/2008	05/02/2008	1	None	PVT	PUB		none	viral illness on 4/29/08			1						1	Injection site erythema; Injection site swelling; Injection site warmth	DTAP~SANOFI PASTEUR~U2354CA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2523AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A04742~4~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1671U~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0311874	05/08/2008	CA	4.0			F	05/07/2008	L deltoid redness, swelling, itching.				Y					Y	05/01/2008	05/01/2008	0	None	PVT	PUB	None	None	None			1						1	Injection site erythema; Injection site pruritus; Injection site swelling	DTAP~SANOFI PASTEUR~U2359CA~5~UN~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2498AA~4~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1788U~2~UN~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0311902	05/08/2008	NY	62.0	62		M	05/08/2008	Pt. was given Influenza immunization 11-05-07.  Wife states approximately 10 days later, he experienced neck pain, tingling in hands and feet.  Seen at ED, and followed up with Primary care physician.  Treated for muscle strain.  Symptoms worsened, pt became weak and was unable to stand. On 11-22-07 he was sent to hospital by ambulance, transferred to Hospital.  Was placed on ventilator.  Wife states dx: Guillain Barre syndrome.  Pt has had several episodes of pneumonia.  Is currently hospitalized at Hospital and Clinic on the Ventilator unit.  06/16/2008 MR received for DOS 11/22/2007-01/08/2008 with D/C DX: Severe Guillain Barre Syndrome.  Ventilator-assisted pneumonia of the LLL. UTI.  HTN. Respiratory Failure s/p tracheostomy.  Dysphagia s/p PEG tube placement. Neuropathic Pain.  Major depressive episode and anxiety.  Stage II skin breakdown.  Hyperglycemia. Pt presented to ER with 6 day hx of ascending weakness and tingling of the fingers and toes. Unable to ambulate, several recent falls. (+) shortness of breath while walking and talking.  PE (+) for decreased inspiratory effort, tachycardia, lower extremity flaccidity and decreased strength. Reflexes decreased. Pt developed respiratory failure and was intubated and vent dependant. Trach placed on 12/4/07. (+) Autonomic instability with tachycardia and hyper and hypotension. Tx with IVIG with no significant improvement.  Neuropathic pain present.  Pt developed some depression, anxiety, a LLL pneumonia, a stage II ulcer of the R buttocks.  PEG tube place for nutrition. Discharged to a ventilator unit for continued rehab.			Y	Y	Y	48	Y		U	11/05/2007	11/22/2007	17	Unknown. Labs and Diagnostics:  LP with CSF protein 158, otherwise WNL with (+) RBCs.  EEG abnormal reflecting underlying encephalopathy. Brain MRI abnormal.  MRI cervical, thoracic and lumbar spine (+) for degenerative disc changes. Venous doppler studies (+) for a non-occlusive thrombus in the superior basilic vein. Lower extremities WNL. Echocardiogram WNL. Sputum cx (+) for Staph aureus.	UNK	UNK	Unknown	None	Unknown. PMH:  BPH. Sensitive to Vicodin. Current URI symptoms.			1						1	Asthenia; Dysstasia; Guillain-Barre syndrome; Mechanical ventilation; Muscle strain; Neck pain; Paraesthesia; Pneumonia; Abasia; Laboratory test; Mechanical ventilation; Movement disorder; Neck pain; Pain; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80684~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|UNK~UNKNOWN MANUFACTURER~~UNK~UN~LA~VACCINE NOT SPECIFIED (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation	Influenza
0311987	05/09/2008	MN	57.0	57		M	05/09/2008	information is a verbal report from spouse, onset of illness 32 days after vaccination, treated by primary care MD, thought he had a virus, became blind by 11/21/07, continued deterioration to death. Autospy preformed: found patient had a demylinating process as cause of death.  05/27/08 Autopsy report reviewed which states COD as presumed acute pneumonia (autopsy limited to examination of brain).  Report also states clinical hx of acute respiratory failure, febrile illness & staph aureus & e.coli dx on bronchoalveolar lavage 1/14/08.  Other contributing conditions included: acute aggressive multifocal demyelinating disease w/white matter lesions multiple areas of the brain including previous biopsy sites & cervical spinal cord; cerebral atrophy & edema.  9/26/08 Reviewed hospital medical records of 1/3-/-19/2008. FINAL DX: multiple CNS lesions w/gadolinium-enhancing CNS lesions; myalgia; hypoxic respiratory failure; dysphagia; poor oral intake; nutrition; possible pneumonia; prophylaxis. Records reveal patient experienced re-admission for brain biopsy which revealed acute demyelinating process.  Failed high dose steroids & plasma exchange.  Tx w/mitoxantrone treatment & second course of high dose steroids in ICU.  Mental & respiratory status deteriorated, significant muscle spasms & pain.  Mechanical ventilation.  Brain lesions continued to grow & new lesions appeared.  Developed decerebrate posturing.  Comfort care only decided & transferred to hospital closer to family home.  5/23/08 Reviewed initial eye clinic records of 11/29-11/30/2007 FINAL DX: probable retrobulbar ischemic ACON. Records reveal patient experienced HA x 3 days & blurred vision x 1 day.  Patient had viral infection w/fever approx 10 days prior & still has sore eyes & stiff neck.  Referred to neuro-ophthal.  6/6/08 Reviewed neuro-optho medical records for 11/30-12/2/2007. FINAL DX: bilateral optic neuritis Records reveal patient seen in clinic 11/30 emergently & admitted to hospital same day.  Had used Cialis & noted difficulty reading next AM w/HA.  Then developed blurry vision, decreased vision & pain over 3 days.  Exam revealed visual acuity hand motion in right eye & 4/200 left eye, IOP WNL, no ptosis, slit lamp WNL, fundus w/1(+) edema of right optic nerve & trace edema left optic nerve.  Admitted for stat MRI & IV steroids.  No improvement & D/C to home on continued tapering steroids.    7/4/08 Reviewed hospital medical records of 11/30-12/02/2007 which were previously included in clinic records. FINAL DX: bilateral optic neuritis	Y	01/21/2008			Y	19			N	10/16/2007	11/18/2007	33	unknown  LABS: MRI of orbits revealed bilateral optic nerve enhancement (prechiasmal).  Sed rate, CRP, ANA & CBC WNL.	UNK	UNK	unknown	none	none  PMH: cranial atherosclerosis, distant history of melanoma excised 15 yrs ago; erectile dysfunction; DJD.  Bell's palsy s/p swine flu shot, resolved.  Tennis elbow/bursitis, resolved.  Dysuria.  Diabetes.			1						1	Blindness; Death; General physical health deterioration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80685~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0311998	05/09/2008	TX	44.0	44		M	05/09/2008	Small reddish lession about 5-6 mm on both sites of immunizations, with a hx of itching on site?.  Hx. of same reaction to flu vaccine administered on 11/2/07, scar present approximatelly 10 mm with no induration or colloid at site.  No other adverse reactions reported from patient.										05/02/2008	05/03/2008	1	none	UNK	UNK	NONE	NONE	HX. of seassonal allergies e.g. dust, pollen, cats	scare to site of vaccine~Influenza (Seasonal) (Fluarix)~1~44.00~Patient		1						1	Injection site pruritus; Reaction to previous exposure to any vaccine; Vaccine positive rechallenge	DTAP~SANOFI PASTEUR~C2771AA~1~IM~RA~DTAP (DAPTACEL)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA274BA~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB183AA~1~IM~LA~HEP A (HAVRIX)~1	USA		Influenza
0312135	05/12/2008	IL	2.0	2	.6	U		Signif cellulitis, left lat thigh progressed to lower leg				Y					Y	03/11/2008	03/13/2008	2		PVT	PVT						1						1	Injection site cellulitis	DTAP~SANOFI PASTEUR~C2799AA~3~UN~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2445AA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0310921	05/13/2008	MA	0.51	0	.5	M	04/30/2008	Intussusception.				Y	Y	0			U	02/08/2008	03/26/2008	47		PVT	PUB						1						2	Intussusception; Intussusception	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21A127AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2523AA~1~ID~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~VF119AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B26510D~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1129V~3~PO~MO~ROTAVIRUS (ROTATEQ)~1|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B127AA~3~UN~LL~DTAP + HEPB + IPV (PEDIARIX)~2|FLU3~SANOFI PASTEUR~U2523AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~SANOFI PASTEUR~UF119AA~3~UN~RL~HIB (ACTHIB)~2|PNC~PFIZER\WYETH~B26510D~3~UN~RL~PNEUMO (PREVNAR)~2|RV5~MERCK & CO. INC.~1129U~3~PO~MO~ROTAVIRUS (ROTATEQ)~2	USA	Hospitalisation	Influenza
0312154	05/13/2008	IL	75.0	75		M	05/12/2008	Initial report received from a health care professional on 21 December 2007. A 75-year-old male patient with a medical history of COPD, heart disease and penicillin allergy, had received an intramuscular left deltoid injection of FLUZONE, lot number U2511AA on 06 November 2007 and an unspecified amount of time later, developed difuse myalgias and arthralgia, generalized throughout the body. The patient was unsure exactly when the symptoms began and had not been ill at the time of vaccination. It was unknown if the patient had experienced any prior events with past Influenza vaccinations. The patient was evaluated by their physician who prescribed Mobic. The patient did not feel any improvement and Mobic was discontinued. The patient was then prescribed Altram on 20 December 2007. Laboratory testing was performed (date not provided) and included total CK, LDH, Chem12, CRP and Sed Rate; results pending. At the time of the report, the patient had not recovered from the event. Follow-up information was received from the reporter on 02 May 2008; this additional information was determined to meet seriousness criteria. SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. The patient, who reported receiving the flu vaccine yearly, experienced significant muscle aches and pain a short time after receiving FLUZONE in November 2007. An arterial doppler performed on 20 November 2007 was within normal limits. Treatment with Mobic was initiated on 29 November 2007, and discontinues 20 December 2007. Ultram (previously reported as Altram) was initiated 20 December 2007. Laboratory testing performed on 20 December 2007 revealed an elevated sed rate and elevated C-reactive protein (CRP). Repeat testing showed an improved CRP on 27 December 2007, and both the sed rate and the CRP were within normal limits by 20 February 2008. The patient's final diagnosis and Polymyalgia Rheumatica. Additional treatment included Vicodin as needed, and Prednisone. According to the reporter, the patient had recovered from the muscle aches and pains, but continued to take low-dose Prednisone.				Y					N	11/06/2007			Bloodwork - Total CK, LDH, Chem12, CRP, Sed Rate - results pending	PVT	PVT	ASA, QUININE SULFATE, FOLIC ACID, DIOVAN, ADVAIR, COMBIVENT, CRESTOR		The patient had a penicillin allergy and had a past medical history of COPD and heart disease. The patient had not been ill at the time of vaccination.		200704399	1						1	Arthralgia; Blood creatine phosphokinase; Blood lactate dehydrogenase; C-reactive protein increased; Laboratory test; Myalgia; Pain; Polymyalgia rheumatica; Red blood cell sedimentation rate increased	FLU3~SANOFI PASTEUR~U2511AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0312168	05/13/2008	CA	88.0	88		F		Pt had diarrhea. Slight temple headaches, upset stomach, nauseated. Pt took Nexium and that helped her quite a bit. It went on for about a year. Pt still c/o sporadic symptoms. 5/27/08-multiple office records received for DOS 5/10/05-4/2/08-C/O malaise after flu shot.5/4/06-C/O constipation. 6/27/06 legs weak, PE normal.								Y	N	10/14/2005	10/21/2005	7		OTH	OTH	None	No	No			1						1	Diarrhoea; Headache; Nausea; Stomach discomfort	FLU3~GLAXOSMITHKLINE BIOLOGICALS~44AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~RA~PNEUMO (NO BRAND NAME)~1	USA	Disabling	Influenza
0312173	05/13/2008	DC	56.0			F	04/24/2008	Fever, chills, febrile illness, dizziness, acute renal failure, pancytopenia, sepsis symptoms, post flu vaccine - 24 hours after vaccine.					Y	0			U	10/16/2007	10/17/2007	1	plt: 73-104, WBC: 2.4, SCR/BUN: 1.6/43	UNK	UNK			DM, HTN, GI Bleeding, Polyarthritis. Pt received Antivert, Zofran PRN, IV Antibiotics. Pt was R/O for sepsis secondary to symptoms I.E. Pancytopenia and Acute Renal Failure. Pt was treated for possible hypersensitivity reactions: ZANTAC IV, Solu-Medrol. A trial for XIGRIS was considered however, pt started to improve and it did not require Xigris for SARR.			1						1	Blood urea nitrogen/creatinine ratio increased; Chills; Dizziness; Pancytopenia; Platelet count decreased; Pyrexia; Renal failure acute; Sepsis; White blood cell count decreased	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0312178	05/13/2008	NC	10.0	10		M	05/02/2008	Adacel (Tdap) was given to <11 yo pt 10 y & 10 months.										11/16/2007	11/16/2007	0		PVT	PVT					NC08056	1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U2486AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2862AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0312181	05/13/2008	MN	53.0	53		F	05/12/2008	5/12/08 phone call from patient complaining of tenderness and swelling to left axillary - (no temperature) swelling approximately 7.5cm, referred to MD.									Y	05/07/2008	05/08/2008	1		PUB	PVT	OTC - Ranitidine	None	GERD			1						1	Swelling; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~U2514AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB525BA~1~IM~RA~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB172AA~1~IM~LA~HEP A (HAVRIX)~1|TYP~SANOFI PASTEUR~A0446~1~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|YF~SANOFI PASTEUR~UF302AA~1~SC~LA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0312188	05/13/2008	FL	22.0	22		F	05/05/2008	11-01-07 c/o tingling (R) arm and fingers, progressed to (L) arm and fingers over several weeks then progressed to legs in Dec. 2007. 1-03-08 to PCP for same complaints. 4-01-08 to ER with same symptoms as well as tingling (R) side face. 4-23-08 To neurologist for symptoms. Workup continuing. 5/14/08-records received for DOS 4/23/08-Impression:paresthesia. Anxiety-unspecified.Presented to neurologists with C/O sore, numb as well as tingly right arm, began in October 2007 shortly after receiving the flu shot. Pins and needles underneath her skin with sharp shooting pains in arms and legs. Numbness is not constant, comes and goes.  PE normal. Paresthesias are improving. Requesting an MRI for persistent head pain. 5/15/08-records received for DOS /3/08-Assessment:jaw pain causing headaches.				Y						10/31/2007	11/01/2007	1	1-17-08 (approx) Labwork all WNL; 1-28-08 X-ray temporomandibular joint - NSG; 4-01-08 CT Scan - neg 5/14/08-records received-HCG, total not pregnant.  5/15/08-records received- X-ray TMJ bilateral: no significant abnormalities involving temporomandibular joint. X-ray cervical spine unremarkable.	OTH	PVT	None	None	Allergy: PCN 5/14/08-records received-Head injury August 2007 causes persistent pain. History of headaches. Depression as well as anxiety. Panic attacks.			1						1	Computerised tomogram normal; Laboratory test; Paraesthesia; X-ray; Computerised tomogram normal; Laboratory test normal; Paraesthesia; X-ray normal	FLU3~SANOFI PASTEUR~U2465AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2465AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0312214	05/13/2008	UT	27.0	27		F	11/23/2007	Immediately after vaccine given site was swelling with a red flare.  Red rash developed within 1 minute & skin swelling continued.  Gave BENADRYL 50 mg po.  No diff breathing or itchiness.									Y	11/23/2007	11/23/2007	0	Advised pt to get tested for allergies & consider Epi-Pen	OTH	PVT		None				1						1	Immediate post-injection reaction; Injection site erythema; Injection site swelling; Rash erythematous; Skin swelling	FLU3~SANOFI PASTEUR~U2463AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0312262	05/13/2008	VA	32.0	32		M	05/13/2008	Pt reports symptoms began 10 min after vaccines given of headache, dizziness, nausea.  Pt was seen at clinic at 1400 pm on 5/12/08 and given Motrin.  Pt states no relief from Motrin.  Pt returned to clinic Immunizations today c/o of worsening of headache, dizziness, nausea.				Y					Y	05/12/2008	05/12/2008	0		MIL	MIL	Bentyl TID and Motrin 800mg q6-8 hrs		Cipro - dizziness, nausea.			1						1	Dizziness; Headache; Nausea	ANTH~EMERGENT BIOSOLUTIONS~FAV163~5~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA312BA~4~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|TYP~SANOFI PASTEUR~A0221~3~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0312285	05/13/2008	NY	46.0			M	05/13/2008	Pain over injection site with limited ROM on abdomen and pain at shoulder.									N				Pending ortho neuro ref.	PVT	UNK	Crestor 20 mg tablet; Free Style Test Strip; Metformin HCI 500 mg tablet extended release 24 hour; Naproxen DR 500 mg tablet delayed release; NovoLog 100 unit/ML solution; Ramipril 10 mg capsule; Zetia 10 mg tablet.					1						1	Injected limb mobility decreased; Injection site pain; Musculoskeletal pain	FLU3~SANOFI PASTEUR~U2523AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0312313	05/14/2008	KS	43.0	43		M	05/14/2008	Developed tachycardia, weakness in the lower extremities, followed by elevated blood pressure and left arm, chest, arm, neck, and back pain.  Pain and weakness continue today as well as elevated blood pressure.  I have been diagnosed with Brachial Neuritis as a result of receiving the flu shot.  I continue treatment at another facility. 7/21/08-records received for DOS 11/27/07-After flu vaccine on 11/7/07-C/O feeling bad, chest pain, back pain and left sided neck pain. Cramp like pain across chest. Dysphagia. Assessment:atypical chest pain. 12/3/07-C/O tremor and tic of temporal muscles eye, epididymitis.  Follow-up Information 12-JUN-2009: Numbness in the left leg and arm. Headaches daily. Upper left chest and back pain. Fatigue and weakness. Lacking stamina. A rise in blood pressure. I have been to specialists who have run test and determined that I have chronic polyneuropathy as a result of Guillain-Barre Syndrome from receiving flu shots.			Y	Y	Y	24		Y	N	11/07/2007	11/07/2007	0	7/21/08-records received-Treadmill test and stress ECHO normal.	UNK	UNK	None	None	None 7/21/08-records received-PMH: reaction to flu vaccine developed epididymitis.			1						1	Angina pectoris; Asthenia; Back pain; Blood pressure increased; Chest pain; Fatigue; Feeling abnormal; Guillain-Barre syndrome; Headache; Hypoaesthesia; Muscular weakness; Neck pain; Pain in extremity; Polyneuropathy chronic; Radiculitis brachial; Tachycardia	FLU3~SANOFI PASTEUR~U2501AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0312378	05/15/2008	OH	61.0	61		M	10/26/2007	SLIGHT METALLIC TASTE IN MOUTH, BACKACHE AND CHILLS, STATED HE FELT LIKE HE WAS GETTING A UTI OR KIDNEY INFECTION.  DRANK 2 GLASSES OF CRANBERRY JUICE AND FELT BETTER THE NEXT DAY									Y	10/24/2007	10/24/2007	0	NONE	UNK	UNK	LISINOPRIL AND ATENOLOL	NONE	SEASONAL ALLERGIES, HTN			1						1	Back pain; Chills; Dysgeusia	FLU3~SANOFI PASTEUR~U2527AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0312500	05/16/2008		78.0			F	05/16/2008	This case was reported by a consumer's daughter and described the occurrence of dizziness in a female patient who received Lamictal unspecified tablet for an unknown drug indication.  A physician or other health care professional has not verified this report.  The patient's past medical history included seizure and stroke.  On an unknown date, the patient started lamotrigine (oral) at 75 mg, unknown dosing.  At an unknown time after starting lamotrigine, the patient experienced dizziness.  At the time of reporting, the outcome of the event was unknown.  The daughter stated she was concerned about her mother taking 75 mg of Lamictal after having a stroke and one seizure.  Her mother only weighs 100 pounds and complains of being dizzy.  The daughter wanted to know how the medication could be evaluated and hopefully reduced.  Follow-up information was received from the subject's daughter on 08 May 2008.  The subject was a 78 year-old female who experienced a seizure after being vaccinated with flu vaccine (manufacturer unspecified).  A physician or other health care professional has not verified this report.  The subject's medical history included a hemorrhagic stroke on 02 October 2006, for which she was hospitalized for seven days, as they attempted to regulate/lower her blood pressure.  The subject was then transferred to a rehabilitation facility, until she was discharged on 23 October 2006.  Concurrent vaccination given on 01 November 2006 included pneumonia vaccine, unspecified; manufacturer unspecified.  Concomitant medications included lisinopril, amlodipine, simvastatin, hydrochlorothiazide, vitamins, and possibly aspirin.  The subject's history of adverse events with previous vaccinations was not reported.  On 01 November 2006, the subject received an unspecified dose of flu vaccine (unknown).  On 01 November 2006 at 21:00, less than one day after vaccination with the flu vaccine, the subject experienced a seizure.  The subject was taken to the emergency room and was hospitalized overnight.  An unspecified test given the next day confirmed that the subject experienced a seizure.  The subject was prescribed treatment with Lamictal and was started on the Orange Kit formulation and dosing of the medication.  On Week 5 of Lamictal therapy, the subject started taking one 25 mg tablet in the morning and two tablets at night.  The subject's daughter reported that her mother was almost back to normal, but still has some memory loss.  In addition, she stated that her daughter experienced some dizziness while on Lamictal therapy.  At the time of reporting, the seizure was resolved; the memory loss was unresolved; and the outcome of the dizziness was unspecified.  The subject declined to provide further information and declined to provide authorization to contact her physician for additional information.					Y	1			N	11/01/2006	11/01/2006	0	The subject had an unspecified test while hospitalized on 02 November 2006, which confirmed that she had experienced a seizure.	OTH	OTH	Lamictal; lisinopril; amlodipine; simvastatin; hydrochlorothiazide; multivitamin; aspirin	Unknown	The subject's daughter reported that her mother was healthy and took no medications initially. The subject's history of adverse events with previous vaccinations were not reported. Concomitant medications at the time of vaccination with the influenza vaccine included vitamins and possibly aspirin. The subject had regular eye and dentist visits, but did not have a regular family physician. On 02 October 2006, the subject had a stroke bleed and was hospitalized for 7 days as they tried to regulate/lower her blood pressure. The subject was then transferred to a rehabilitation facility, until she was discharged on 23 October 2006. According to the subject's daughter, her mother had no seizures nor strokes for the past five months at the time of this report.		A0722930A	1						1	Amnesia; Convulsion; Dizziness; Laboratory test abnormal	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0312553	05/19/2008	TN	46.0	46		F	11/19/2007	Friday 11/16/07 about 930AM received flu shot, felt tender that night, was like whelp hasn't gotten bigger. Allergy PCN; has gotten flu shot before; No other symptom. (3cm diameter); Patient also had sinus infection given CIPRO 500mg 1 tab po Bid #20									Y	11/16/2007	11/16/2007	0	None	PUB	PUB	HRT patch, thyroid	None	Allergy PCN.		TN07038	1						1	Injection site pain; Injection site urticaria; No reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~U2528AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0312554	05/19/2008	TN				F	11/28/2007	11/28/07 patient stated she had bruise on her left arm after getting flu shot 11/14/07; it hurt the day after and constantly since.  Bruise went away this past weekend.  Deep hurting inside arm with burning per phone call to clinic 3 PM today.  Information per phone 11/28/07 cancelled 3 PM appointment.										11/14/2007				PUB	PUB					TN07039	1						1	Burning sensation; Contusion; Pain in extremity	FLU3~SANOFI PASTEUR~U2499AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0312616	05/19/2008	VA	51.0	51		M		After leaving clinic patient passed out at desk while at work; was taken to ER and released.				Y					Y	05/13/2008	05/13/2008	0	EKG - normal, blood pressure	MIL	MIL	PPD	None	None			1						1	Blood pressure; Electrocardiogram normal; Loss of consciousness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA038AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB525BA~1~IM~RA~HEP B (ENGERIX-B)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~C2758AA~UNK~IM~LA~TDAP (BOOSTRIX)~1|TYP~SANOFI PASTEUR~A0394~UNK~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0312658	05/20/2008	CA	43.0	43		F	05/14/2008	11/19/07 Influenza vaccine was administered at a regular doctor's visit and a couple of days later started feeling weakness, numbness and pain in lower back and legs and again on 3/15/08 after being sick with severe flu symptoms ended up in the emergency room and was administered another influenza and pneumonia vaccine that made my entire body from neck back became numb and weak.				Y	Y	4	Y	Y	N	11/19/2007	03/15/2008	117		PVT	UNK	Topomax; Provigil; Flexeril; Estrace; Ibuprofen; Advair	Since first influenza vaccine on 11/19/08 sick with flu symptoms	Allergies to most narcotics. Medical conditions fibromyalgia; epilepsy; asthma	weakness, pain, numbness~Influenza (Seasonal) (no brand name)~1~43.00~Patient		1						1	Abasia; Abdominal pain lower; Arthralgia; Asthenia; Back pain; Balance disorder; Bronchitis; Chest discomfort; Chills; Condition aggravated; Cough; Culture urine negative; Dizziness; Dyspnoea; Dysuria; Electromyogram normal; Fatigue; Gait disturbance; Headache; Hypoaesthesia; Influenza; Lumbar radiculopathy; Malaise; Micturition urgency; Middle ear effusion; Muscle strain; Muscular weakness; Myalgia; Myopia; Nerve conduction studies normal; Neurological examination normal; Nuclear magnetic resonance imaging normal; Oropharyngeal pain; Otitis media acute; Otorrhoea; Pain; Pain in extremity; Paraesthesia; Protein urine present; Pyrexia; Respiratory tract congestion; Sinus headache; Sleep disorder; Tympanic membrane disorder; Tympanic membrane perforation; Urine leukocyte esterase positive; Viral infection; Vision blurred	FLU3~SANOFI PASTEUR~U2515AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0312660	05/20/2008	PA	0.5	0	.5	M	05/09/2008	Patient had 103.5 temperature and continued with 101.7 temperature for 3 days.  Respiratory illness started after temperature with decreased appetite and cough with congestion for approximately 2 weeks.  Had atonic/drop seizure x 2 and was hospitalized 01/22/08 - 01/30/08 had convulsive seizure x 2 in hospital.  All tests came back and was diagnosed with viral encephalitis and seizures.  Hospitalized in February due to poor seizure control. 6/3/08-records received for DOS 1/22-1/30/08-DC DX: Seizures. Mild viral encephalitis. Presented with two atonic episodes. Cough. Sleepier, high pitched cry. Abnormal movements with facial twitching. Post-ictal. Altered mental status with high pitched cry, failure to focus, fussiness and loss of truncal stability. Developed diarrhea.				Y	Y	10	Y		U	12/20/2007	12/26/2007	6	Lumbar puncture x 2, MRI, EEG x 3, blood cultures, urine culture, tubular schrosis genetic test, chest x-ray, head CT. 6/3/08-records received-Brain MRI normal. EEG intermittent left temporal slowing some voltage asymmetry with right hemisphere having lower voltage. CSF culture negative. BMP normal. UA negative. CBC normal. EKG normal. HSV 1 IgG negative.	PVT	UNK	None					1						1	Atonic seizures; Body temperature increased; Chest X-ray; Computerised tomogram; Convulsion; Cough; Culture urine; Decreased appetite; Electroencephalogram; Encephalitis viral; Lumbar puncture; Pyrexia; Respiratory disorder; Respiratory tract congestion	FLU3~SANOFI PASTEUR~U2527AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0312707	05/20/2008		44.0	44		M	05/20/2008	Received smallpox vaccination 31MAR08.  Arrived in country 09APR08. Reports some SOB/discomfort on 10APR08 but attributed it to travel.  Came in 12APR08 c/o swollen lymph nodes.  Seen in EMT and sent home.  Rash appeared during the night 13APR08 and member returned to outpatient clinc on 14APR08.  States rash started as small bumps then increased. VSS @ 122/73, HR 87, RR 21, T 98.3 F. Physician noted multiple fluid filled vesicles on erythematous base on arms, back of hands, back of neck, and upper back.  No pustules/no crusting yet.  Eschar over L deltoid at site of vaccination, scaley/irregular annular plaque on L calf.  Patient placed on contact precautions with daily follow ups.  Redness to eye noted and seen by optometrist who gave him some steroid eye drops.  Over the next few days rash resolved.				Y					Y	03/31/2008	04/29/2008	29	slit lamp	MIL	OTH	none	none	childhood asthma; treatment in past with steroidal cream for small dry patch on leg			1						1	Blister; Blood pressure normal; Body temperature; Discomfort; Dyspnoea; Eschar; Heart rate normal; Lymphadenopathy; Ocular hyperaemia; Rash; Rash erythematous; Respiratory rate; Slit-lamp examination	FLUX~UNKNOWN MANUFACTURER~~UNK~SYR~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0312713	05/20/2008	MS	19.0	19		M	05/20/2008	Approx, 10 minutes after a flu shot was given, the pt. passed out. Ammonia inhalants were used to revive pt. After 30 sec. to 1 min, pt. passed out again. He did this two more times. EMS personnel were called and arrived a few minutes later. Emergency personnel walked him to the ambulance and transported to the Hospital ER. Vitals signs were taken before pt. left. BP-128/102, Resp. 32, Pulse- 108. In the ER the pt. was given ativan, then transferred on 5/16, treated with Cerebyx (fosphenytoin), then onto dilantin, evaluated with EEGs, discharged on 5/18, with diagnosis of new onset of seizures.  6/9/2008 MR received for DOS 5/16-18/2008 with D/C Dx: Vasovagal Syncope. Pt presented to ER after an episode of loss of consciousness after flu vax with jerking movements bilaterally. Pt was awake and talking while the jerking movements were happening. Tx with Ativan as thought to be Grand Mal Seizures. Neuro consult with Impression:  Loss of consciousness. ? vasovagal syncope. Seen 5/17 following episode with no LOC. Atypical seizures vs vasovagal Seen 5/18/08 with reported chest tightness, dizziness. Pt swaying upon standing and walking. D/C to f/u with PCP.				Y	Y	2			U	05/16/2008	05/16/2008	0	Blood Lab results taken on 14 May 2008. Showed the pt. was immune to Hep A, Hep B, Rubella, Rubeola, and Varicella.  Labs and Diagnostics:  K+ 3.4. CT brain (-). PE WNL except for being sleepy 2' to Ativan.  EEG with slow background activity.  No epileptiform activity	MIL	MIL	PPD Mantoux skin test given on 14 May 2008 Left forearm. Read on Friday 16 May 2008 with a 14mm induration reading.	None	No Allergies, birth defects or other medical conditions listed on DD Form 2808 (Report of Medical Examination) dated 29 Jan 2008 and signed by MD.	?~ ()~~0.00~Patient|?~ ()~~0.00~Sibling|?~ ()~~0.00~Sibling		1						1	Blood pressure; Blood test; Convulsion; Electroencephalogram; Heart rate; Hepatitis A antibody positive; Hepatitis B antibody positive; Loss of consciousness; Measles antibody positive; Respiratory rate; Rubella antibody positive	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA049AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation	Influenza
0312979	05/22/2008	NM	33.0	33		M	05/21/2008	34 y.o. male traveling to numerous countries received MENACTRA in R delt, TWINRIX & flu in L delt.  Two days later reported lymphadenopathy-size of a golf ball in R axilla-was out of town-called to be examined.  Monitored daily over phone with no worsening sx.  Improvement.  Has history of MRSA in R groin hospitalized.  Vanc. BACTRIM in 11/07 with reoccurrence in 01/08.									Y	04/21/2008	04/23/2008	2		PVT	PVT		None	History of MRSA 11/07 with reoccurrence in 01/08 treated with BACTRIM x3	none known~ ()~~0.00~In Patient		1						1	Lymphadenopathy	FLU3~SANOFI PASTEUR~U2512AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB116AA~1~IM~LA~HEP A + HEP B (TWINRIX)~1|MNQ~SANOFI PASTEUR~U2571AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TYP~BERNA BIOTECH, LTD.~3001339~1~PO~MO~TYPHOID LIVE ORAL TY21A (VIVOTIF)~1	USA		Influenza
0312997	05/22/2008	WA	1.05	1	.1	M	05/16/2008	It was discovered after vaccine was given that the freezer temperature was out of the correct storage range for the MMRV.  Per manufacturer doses were compromised therefore this MMRV dose is invalid.									Y	05/01/2008	05/01/2008	0		OTH	PUB	None Reported	None Reported	None Reported			1						1	Medication error	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B129AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2477DA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB222AA~1~IM~RL~HEP A (HAVRIX)~1|MMRV~MERCK & CO. INC.~0651U~1~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~C35172~1~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0312998	05/22/2008	WA	5.0	5		M	05/16/2008	It was discovered after vaccine was given that the freezer temperature was out of the correct storage range.  Per manufacturer doses (MMRV) were compromised therefore, this MMRV is invalid.									Y	04/24/2008	04/24/2008	0	None	OTH	PUB	None	None reported	None reported			1						1	Medication error	DTAP~SANOFI PASTEUR~C2606AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2502AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB222AA~1~IM~RA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~A0170~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMRV~MERCK & CO. INC.~0651U~2~SC~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0313013	05/22/2008	VA	39.0	39		M	05/22/2008	Influenza vaccination left upper arm 22May 2007. Pt had immediate pain (5/10) at the injection site which lasted 30 sec. About 6 hours later the pt noted redness and swelling from his shoulder to his elbow. He also had an achy pain (3/10) and itching around the injection site. He also felt tired and weak. He denied decrease ROM, strength, numbness/tingling in his left shoulder, arm or hand. He denied fever, N, V, diarrhea, rash, SOB, chest pain. Instructed to take Motrin and Benadryl which he did about 2 hours later. Pt slept all nite. Redness, swelling and pain were 50% better in the am. Itching had resolved. Pt took one more dose of Motrin and Benadryl that am. All sx resolved in 3-4 days.				Y					Y	05/22/2007	05/22/2007	0	na	MIL	MIL	none	none	none	local reaction~Anthrax (no brand name)~5~0.00~Patient		1						1	Asthenia; Erythema; Fatigue; Immediate post-injection reaction; Injection site pain; Injection site pruritus; Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~U2308AA~7+~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0295237	05/23/2008	TX	9.0	9		M	05/16/2008	Information has been received from a Registered Nurse concerning a 9 year old male with a penicillin allergy who on 30-OCT-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #658597/1336U). Concomitant therapy included FluMist. On 30-OCT-2007, the patient experienced difficulty breathing, hives, cough and facial edema. The patient was treated with Benadryl, epinephrine, albuterol and Decardon. The patient recovered on the same day. Additional information has been requested. 3/25/2010 Follow up informtion received from the nurse. She didn't have any further information to provide regarding the case. Further information is not expected.									Y	10/30/2007	10/30/2007	0	Unknown	UNK	UNK		Penicillin allergy			WAES0711USA00010	1						3	Cough; Dyspnoea; Face oedema; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3|VARCEL~MERCK & CO. INC.~1336U~UNK~UN~UN~VARICELLA (VARIVAX)~3	USA		Influenza
0296252	05/23/2008	WA	5.0	5		F	05/16/2008	Information has been received from a health professional concerning a 5 year old female who on 08-NOV-2007 was vaccinated SC with her second dose of VARIVAX (lot# 658932/1343U) in the left arm. There was no illness at the time of vaccination. Suspect vaccination administered on that same day included the sixth IM dose of FLUZONE (lot# U2490AA) in the left deltoid. On 09-NOV-2007 that patient presented to the clinic with a 2 x 2.5cm size that was indurated and warm at injection site. The outcome was unknown. Follow-up information indicated that no further treatment was necessary for the patient. No further information is available.									Y	11/08/2007	11/09/2007	1	Unknown	PVT	OTH	Unknown		Unknown		WAES0712USA01860	1						2	Injection site induration; Injection site warmth	FLU3~SANOFI PASTEUR~U2490AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|VARCEL~MERCK & CO. INC.~1343U~2~SC~LA~VARICELLA (VARIVAX)~2	USA		Influenza
0296985	05/23/2008	WA	3.0	3		F	05/16/2008	Information has been received from a physician concerning a 45 month old female who on 13-NOV-2007 at 18:00 hours, received her second subcutaneous dose in the left of varicella virus vaccine live (Oka/Merck) (lot#658932/1343). Concomitant vaccinations included a third dose of influenza virus whole virion 3v vaccine inactivated (FLUZONE) (lot # U24490AA). It was reported that in the morning of 14-NOV-2007, she developed erythema and warmth around the injection area, and was treated for cellulitis with cephalexin (KEFLEX) for 10 days. There was no relevant diagnostic tests or laboratory data. Current patient status was not reported. A product quality complaint was not reported. Additional information has been requested.									U	11/13/2007	11/14/2007	1	Unknown	PVT	PUB			Unknown		WAES0712USA01872	1						2	Injection site cellulitis; Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U2490AA~3~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|VARCEL~MERCK & CO. INC.~658932/1343U~2~SC~UN~VARICELLA (VARIVAX)~2	USA		Influenza
0296986	05/23/2008	WA	5.0	5		F	05/16/2008	Information has been received from a physician concerning a 5 year old female with no pre-existing medical conditions or allergies who on 05-NOV-2007 at 13:30 was vaccinated SC with her second dose of VARIVAX (lot# 658932/1343U) in the left thigh. There was no illness at the time of vaccination. Concomitant vaccinations administered on that same day at 13:30 included the fourth SC dose of IPOL (lot# Z10692) in the left thigh and the first intranasal dose of FLUMIST (lot# 500489P). On the morning of 11-NOV-2007 the patient developed a hive-like rash all over face, neck, trunk and lower extremities with papules 0.5 cm to 10 cm in diameter. It was noted that no vesicles were present. The patient did not seek medical attention. The patient was treated with anti-itch therapy only. The outcome was unknown. Follow-up information from the reporting physician indicated that there were no further problems with this patient.									Y	11/05/2007	11/11/2007	6	Unknown	PVT	OTH			None		WAES0712USA01873	1						2	Rash papular; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500489P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|IPV~SANOFI PASTEUR~Z10692~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~2|VARCEL~MERCK & CO. INC.~1343U~2~SC~LL~VARICELLA (VARIVAX)~2	USA		Influenza
0312188	05/23/2008	FL	22.0	22		F	05/21/2008	Initial report was received 12 May 2008 from a health care professional.  A 23-year-old female patient with a history of penicillin allergy, had received a right deltoid injection of FLUZONE SV 2007-2008, lot number U2465AA (route not reported), and one day later, she complained of tingling in her right arm and fingers.  The tingling progressed to her left arm and fingers over several weeks, and then progressed to her legs in December 2007.  She was seen by her primary care provider on 03 January 2008 for these same symptoms.  On approximately 17 January 2008, laboratory testing was performed with normal results (specific lab tests not reported).  A temperomandibular joint x-ray had been performed on 28 January 2008 with negative results.  On 01 April 2008, the symptoms of tingling had not resolved and the patient had an additional symptom of tingling on the right side of her face so she went to the emergency room.  A CT Scan was performed at that time with negative results (site assessed not reported).  The patient had no illness and had not been taking any medications at the time of vaccination.  She was evaluated by a neurologist on 23 April 2008 and her neurological work-up continued at the time of the report.				Y					N	10/31/2007	11/01/2007	1	17/Jan/2008 (approximately), Labs, all normal; 28/Jan/2008, X-ray - Temperomandibular joint, (negative); 01/Apr/2008, CT Scan, negative	OTH	UNK			The patient had a known allergy to penicillin.  The patient had no illness at the time of vaccination and had not been taking any concomitant medications.		200801519	1						2	Computerised tomogram normal; Laboratory test; Paraesthesia; X-ray; Computerised tomogram normal; Laboratory test normal; Paraesthesia; X-ray normal	FLU3~SANOFI PASTEUR~U2465AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2465AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0313132	05/23/2008	NM	92.0	92		F	05/21/2008	This case was received from a consumer on 13 May 2008. A consumer reported that his 92-year-old mother received an injection of Influenza Vaccine (manufacturer and lot number not reported) on 29 November 2007. At the time of vaccination, the subject had high blood pressure. Two days after vaccination, on 01 December 2007, the patient began experiencing dizziness, nausea, and vomiting. She was diagnosed with pneumonia, and admitted to the hospital for 14 days. She later developed shingles on her forehead. She died on 12 January 2008; cause of death on the death certificate was heart attack according to the patient's son. No autopsy was performed. 6/16/08-records received for 12/03/07-presented obtunded and unresponsive. Felt weak and limp, gurgling and wheezing, falling towards left side. Appeared to improved but had sudden listless and fever, delirious and gurgling. ED assessment:CHF exacerbation. Assessment viral versus bacterial community acquired pneumonia.  7/18/08-records received for DOS 12/4-12/7/07-DC DX: Community-acquired pneumonia. Pulmonary edema. Presented to ED less responsive than baseline. PE:rales.  9/24/08-records receivedOD-cardiac arrest. Probable myocardial infarction. Possible aspiration.	Y	01/12/2008			Y	3			N	11/29/2007	12/14/2007	15	6/18/08-records received-Sodium 130, BNP 2460. Troponin 0.04. CXR no acute finidng. Echocardiogram normal. blood culture negative.	UNK	UNK			High blood pressure. 6/18/08-records received-PMH: dementia, hypertension. osteoporosis, left hip fracture 11/05.		200801534	1						1	Death; Dizziness; Herpes zoster; Myocardial infarction; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0313412	05/23/2008	TX				U	05/16/2008	Information has been received from a registered nurse concerning two patients who were vaccinated with a dose of VARIVAX. Concomitant therapy included influenza virus vaccine (unspecified). The two patient developed anaphylactic reaction and were both sent to the emergency room for treatment. It was noted that the above information was on a fax that the office received from the another hospital. The two patients not patients from this office. No other information was available. Unspecified medical attention was sought. There was no product quality complaint. The event was considered an other medical event by the reporter. This is one report of several from the same source. Additional information has been requested.				Y					U				Unknown	OTH	OTH			Unknown		WAES0711USA00407	1						1	Anaphylactic reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~~UNK~UN~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0313649	05/23/2008	MA	17.0	17		F	05/16/2008	Information has been received from a registered nurse concerning a 17-year-old female with no pertinent medical history or allergies who on 27-APR-1998 was vaccinated subcutaneous with her first 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot # 658406/1175U) and her second dose on 17-SEP-2007. Concomitant therapies included amitriptyline hydrochloride (MSD), ethinyl estradiol/norgestimate (TRI-SPRINTEC) and another vaccine administered on 17-SEP-2007. On 20-SEP-2007 the patient experienced redness, pain, swelling and itching at the injection site of the left upper arm. The patient was examined in the office later the same day and the exam revealed 8x7 cm area of redness with a central 1.5x1.5 cm induration. The physician recommended cool compress and BENADRYL. No diagnostic labs were performed. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Follow-up information received on 07-DEC-2007 indicated the patient was vaccinated at 15:00 subcutaneous in the left arm on 17-SEP-2007 with a second dose of varicella virus vaccine live (Oka/Merck) (lot # 658406/1175U) (lot # 658406/1175U was previously reported as the first dose). There were no illnesses at the time of vaccination. Concomitant vaccines administered on 17-SEP-2007 at 15:00 included a first intramuscular dose of BOOSTRIX (lot # AC528015AA), a first intramuscular dose of MSD vaccine (yeast) (lot # 658560/1062U) and a fifth intramuscular dose of FLUZONE vaccine inactivated (lot # U2436AA). On 19-SEP-2007 (previously reported as 20-SEP-2007) the patient experienced 8x7 cm area of redness with a 1.5x1.5 cm induration on the left post arm at the site of the varicella virus vaccine live (Oka/Merck) injection. The patient was seen in the office of the 20-SEP-2007 for red, swollen itch. On 01-OCT-2007 the patient was seen at a visit and was okay. Additional information is not expected.				Y					Y	09/17/2007	09/17/2007	0	None	PVT	PVT	ELAVIL, TRI-SPRINTEC		None		WAES0709USA03842	1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site pruritus; Injection site swelling	FLU3~SANOFI PASTEUR~U2436AA~5~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~658560/1062U~1~IM~~HPV (GARDASIL)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B015AA~1~IM~~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~658406/1175U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0313668	05/23/2008	OR	12.0	12		M	05/16/2008	Information has been received from a medical assistant concerning a 12 year old male patient who was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #658432/1246U). Subsequently the patient developed an injection site reaction described as in. There was no product quality complaint. Follow-up information was received which reported that on 09-OCT-2007 the 12 year old whThis report is one of several fite male patient with no pre-existing allergies, birth defects, medical conditions was vaccinated subsquently in in the left arm with the second dose of Varivax (lot #658432/1246U). On the same day the patient was also vaccinated with the first dose of FLUZONE (lot #U2443AA) intramuscularly in the right arm. On 12-OCT-2007 the patient rom the same sourc experienced injection site itch. This is one of several reports received from the same source.									U	10/09/2007	10/12/2007	3	Unknown	PVT	PVT	Unknown		Unknown		WAES0803USA00591	1						1	Injection site pruritus; Injection site swelling	FLU3~SANOFI PASTEUR~U2443AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~558432/1245U~2~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0313714	05/23/2008	PA	8.0	8		F	05/16/2008	Information has been received from a health professional concerning an 8 year old female with no known allergies and a history of microscopic hematuria, who on 20-FEB-2008 was vaccinated with a second 0.5 ml subcutaneous dose in the left arm of varicella virus vaccine live (Oka/Merck) (lot# L5006). Concomitant vaccination included a dose in her right arm of hepatitis A vaccine (inactive) (manufacturer unspecified) and a dose in the right arm of influenza virus vaccine (manufacturer unspecified). The health professional reported that the erythmea, and papulule/blister began at 12:00 hours on 23-FEB-2008 (3-5 days post vaccination). It was indicated by the health professional that there were no other rashes or sytemic complaints and that the patient was afebrile. On 25-FEB-2008, the patient was seen in the office and complained of soreness at injection site of the left arm. Within 24 hours (26-FEB-2008, also reported as 23-FEB-2008), the patient developed blisters around the injection site. It was reported that the patient's mother treated the patient with oral diphenhydramine (BENADRYL) and cold compresses. On 28-FEB-2008, the patient had recovered. A product quality complaint was not reported. Additional information has been requested.				Y					Y	02/20/2008	02/23/2008	3	None	PVT	OTH			Microscopic hematuria		WAES0802USA06031	1						1	Erythema; Injection site pain; Injection site vesicles; Rash papular	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~MERCK & CO. INC.~~UNK~UN~RA~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0313913	05/23/2008	NY	5.0	5		M	05/16/2008	Information has been received from a physician concerning a 5 year old male (40 in, 32 lb) with an allergy to beef gelatin and on other pertinent medical history who on 15-OCT-2007 was vaccinated with VARIVAX (Merck) and the flu vaccine.  Within one minute of these injections, the patient had an acute allergic reaction (erythema, sneezy, coughing and listless). Subsequently the patient went to the emergency room where he was treated with epidural, BENADRYL and unspecified steroids.  On an unspecified date, the patient recovered from the event.  Additional information is not expected.				Y					Y	10/15/2007	10/15/2007	0	Unknown	PVT	OTH		Hypersensitivity			WAES0712USA06336	1						1	Listless	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~~UNK~UN~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0313919	05/23/2008	UT	1.3	1	.3	M	05/16/2008	Information has been received from a medical assistant concerning an 18 month old male with no drug allergies who on 08-DEC-2007 was vaccinated IM with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot# 657793/0713U). Suspect vaccination administered during the same visit included a dose of measles virus vaccine live (enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (manufacturer unknown). On 17-DEC-2007, the patient developed a rash on his back described as a clear, blister-looking, slightly red and raised area. The child also had cold-like symptoms including a fever, runny nose and congestion. The patient sought unspecified medical attention. The patient was not recovered at the time of this report. It was also noted that the patient's mother was pregnant and the office was concerned about risk of transmission but no symptoms with the mother were noted. There was no product quality complaint. Follow-up information has been received from the reporting medical assistant concerning a 15 month old (also reported male) who on 08-DEC-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 657793/0713U) in the left thigh. There was no illness at the time of vaccination. Suspect vaccination administered on that day at 10:00 included the first IM dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MDS) (lot # 653626/0426F) in the right thigh. Concomitant vaccinations administered on that same day at 10:00 included the fourth IM dose of Prevnar (lot # B54013H) in the right thigh and the first IM dose of Fluzone (U2502AA) in the right thigh. On 17-DEC-2007 at 07:00 the patient experienced a low grade fever and a chicken pox-like rash. At that same time the patient was pulling at his ear and spit up bloody phlegm. The patient sought medical attention at the clinic. The outcome was unknown. It was noted that the patient's mother was less than 3 months pregnant and did not know how serious the event would be for her. Additional information has been requested.				Y					N	12/08/2007	12/08/2007	0	Unknown	PVT	PUB			Unknown		WAES0712USA07865	1						1	Ear disorder; Haemoptysis; Nasopharyngitis; Pyrexia; Rash vesicular; Respiratory tract congestion; Rhinorrhoea	FLU3~SANOFI PASTEUR~U2502AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0426F~1~IM~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B54013H~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0713U~1~IM~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0313946	05/23/2008	OR	9.0	9		F	05/16/2008	Information has been received from a medical assistant concerning a 9 year old female patient who on 12-DEC-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #657108/0369U). On 14-DEC-2007 the patient experienced an injection site reaction, described as inflamed injection site, injection site swelling and injection site itching. The patient sought unspecified medical attention. There was no product quality complaint. Additional information has been requested. This is one of several reports from the same source. Follow-up information was received which reported that on 12-DEC-2007 the patient with no pre-existing allergies, birth defects or medical conditions was vaccinated subcutaneously in the right thigh with a second dose of VARIAVAX (Oka/Merck) (Lot #657108/0369U). On the same day the patient also received the first dose of HAVRIX (Lot #AHAVB1B2A) and FLUZONE (lot #U2438AA) both given IM in the left thigh. There was no illness at the time of vaccination. On 14-DEC-2007 the patient experienced an injection site reaction in the right thigh, described as inflamed injection site, injection site swelling, itching, redness and hotness. On an unspecified date the patient recovered from the events. Additional information is not expected. This is one of several reports from the same source.									Y	12/12/2007	12/14/2007	2	Unknown	PVT	PUB	Unknown		None		WAES0712USA08938	1						1	Injection site erythema; Injection site inflammation; Injection site pruritus; Injection site reaction; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2438AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB1B2AA~1~IM~UN~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~657108/0369U~2~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0313993	05/23/2008	NH	1.65	1	.7	F	05/16/2008	This is in follow-up to report (s) previously submitted on 5/16/2000. Information has been received from a certified medical assistant concerning a 46 month old female with a history of early onset of delivery and no drug reactions/allergies, who on 14-OCT-2005 was vaccinated SC with a 0.5 mL dose of VARIVAX vaccine(Merck) (lot number: 648083/0072P). Concomitant therapy included measles-mumps-rubella vaccine (MSD) and influenza virus vaccine (unspecified). On 06-JAN-2008, the patient was diagnosed with chickenpox. No other information was available at the time. There were no lab diagnostic studies performed. Unspecified medical attention was sought through a telephone call from the patient's mother. There was no product quality complaint. Follow-up information indicated that the patient was examined by the physician on 14-JAN-2008 and it was determined that her rash was not varicella. No further information was available. Additional follow-up information received indicated that it was determined not to be chickenpox. No additional information is expected.									U	10/14/2005	01/06/2008	814	None	OTH	OTH		Unknown	Early onset of delivery		WAES0801USA02994	1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0072P~UNK~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0313994	05/23/2008					M	05/16/2008	Information has been received from a physician's assistant concerning their son who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (manufacturer unspecified). Concomitant therapy included a dose of influenza virus vaccine (unspecified) given on the same day in the same arm. Subsequently, a few days following the vaccinations, the patient developed chicken pox. The patient sought unspecified medical attention. Subsequently, the patient recovered from chicken pox. No product quality complaint was involved. Additional information is not expected.									Y				Unknown	OTH	OTH			Unknown		WAES0801USA03128	1						1	Varicella; Varicella post vaccine	FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~~UNK~UN~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0314095	05/23/2008	OH	1.0			M	05/16/2008	Information has been received from a nurse practitioner concerning a 12 month old male with no pertinent medical history, drug reactions or allergies who on 27-OCT-2007 was vaccinated subcutaneously with 0.5 mL of varicella virus vaccine live (Oka/Merck) (lot # 658374/1117U). Concomitant therapy included influenza virus vaccine (unspecified) and Prevnar. On 12-NOV-2007, the patient developed redness, local heat and swelling at injection site. The patient recovered from the redness, local heat and swelling at the injection site on an unspecified date. Unspecified medical attention was sought. There was no product quality complaint. There was no lab diagnostic studies performed. Additional information is not expected.				Y					Y	10/27/2007	11/12/2007	16	None	OTH	OTH			None		WAES0802USA03376	1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PNC~PFIZER\WYETH~~UNK~UN~UN~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1117U~UNK~SC~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0314205	05/23/2008	IA	12.0			F	05/16/2008	Information has been received from a nurse concerning a 12 year old female who on 22-OCT-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot number: 658287/1173U). Concomitant therapy that day included Gardasil, Hepatitis A vaccine (inactive) (MSD), Fluzone (manufacturer unknown) Menactra (manufacturer unknown). On 24-OCT-2007, the patient reported redness surrounding the injection site approximately 48 hours after receiving the vaccination. No further information was given. The outcome was reported as recovered on 26-OCT-2007. There was no product quality complaint. Additional information has been requested.									Y	10/22/2007	10/24/2007	2	Unknown	OTH	OTH			Unknown		WAES0710USA06851	1						1	Injection site erythema	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~~UNK~UN~UN~HEP A (VAQTA)~1|HPV4~MERCK & CO. INC.~~UNK~UN~UN~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~1173U~UNK~UN~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0314210	05/23/2008	IA	9.0			F	05/16/2008	Information has been received from a nurse concerning a 9 year old female who on 22-OCT-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot number: 658287/1173U). Concomitant therapy that day included Fluzone (manufacturer unknown), Gardasil and hepatitis A vaccine (inactive) (MSD). The patient experienced 2 centimeters of irregular erythema on her left arm after receiving the vaccination. No further information was given. The outcome was reported as recovered on 26-OCT-2007. There was no product quality complaint. Additional information has been requested.									Y	10/22/2007			Unknown	OTH	OTH			Unknown		WAES0710USA06933	1						1	Erythema	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~~UNK~UN~UN~HEP A (VAQTA)~1|HPV4~MERCK & CO. INC.~~UNK~UN~UN~HPV (GARDASIL)~1|VARCEL~MERCK & CO. INC.~1173U~UNK~UN~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0314242	05/23/2008		9.0			U	05/16/2008	Information has been received from a physician concerning an approximately 9-year-old child who was vaccinated on an unspecified date with a dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccination included a dose of influenza virus split virion 3v vaccine inactivated (FLUZONE (influenza virus split virion 3v vaccine inactivated) (Sanofi Pasteur). Subsequently the patient experienced a possible anaphylactic reaction which included wheezing, shortness of breath, facial edema and facial mottling. The patient was stabilized and transported to the nearest hospital. No other information was available. This event not occur at the reporting physicians office. This is one of several reports from the same reporter. Additional information has been requested,				Y					U				Unknown	OTH	OTH			Unknown		WAES0711USA00277	1						1	Dyspnoea; Face oedema; Livedo reticularis; Wheezing	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~~UNK~UN~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0314259	05/23/2008		9.0			U	05/16/2008	Information has been received from a physician concerning a 9-year-old child who was vaccinated on an unspecified date with varicella virus vaccine live (Oka/Merck). Concomitant vaccination included influenza virus 3v reassortant vaccine live intranasal (cold adapted Ann Arbor master strain) (FLU MIST) (MedImmune). Subsequently the patient experienced a possible anaphylactic reaction which included wheezing, shortness of breath, facial edema and facial mottling. The patient was stabilized and transported to the nearest hospital. No other information was available. This event did not occur at the reporting physicians office. This is one of several reports from the same reporter. Additional information has been requested.				Y					U				Unknown	OTH	OTH			Unknown		WAES0711USA00456	1						1	Dyspnoea; Face oedema; Livedo reticularis; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~~UNK~UN~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0314274	05/23/2008	CA	5.0			F	05/16/2008	Information has been received from a physician concerning a 4 or 5-year-old female who on 13-OCT-2007 was vaccinated in the arm with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 08246). Concomitant therapy included a dose of influenza virus vaccine (unspecified) which was administered in the other arm. On 14-OCT-2007 the patient developed a half-dollar, circular sized, raised, red, itchy rash at the injection site that lasted for about 3 to 4 days. Medical attention was no sought. Subsequently, the patient recovered on approximately 18-Oct-2007. No product quality complaint was involved. Additional information has been requested.									Y	10/13/2007	10/13/2007	0	Unknown	OTH	OTH			Unknown		WAES0711USA01358	1						1	Injection site erythema; Injection site pruritus; Injection site rash	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~~2~UN~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0314290	05/23/2008	CO	63.0	63		M	05/16/2008	Information has been received from a registered nurse concerning a 63 year old male with no pre-existing allergies, birth defects or medical conditions, who was vaccinated in the right arm at 10:00 AM with a first dose of varicella virus vaccine live (Oka/Merck) (lot number: 658763/1341U) instead of zoster vaccine live (Oka/Merck).  Concomitant medications included: influenza virus vaccine (unspecified) and pneumococcal 14v polysaccharide vaccine (manufacturer unknown). Nurse stated this was not a product quality complaint, staff error only. There was no adverse events recorded. There was no illness at time of vaccinations. There were no adverse events following prior vaccinations. No other information. Unspecified medical attention was sought. The patient was seen in the office. The outcome was reported as recovered. Additional information has been requested.				Y					Y	11/12/2007			Unknown	PVT	PVT			None		WAES0711USA2649	1						1	No adverse event; Wrong drug administered	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~1341U~1~UN~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0314310	05/23/2008	NJ	11.0	11		F	05/16/2008	Information has been received from a physician concerning an 11 year old 79 1/2 lb. 55 1/2 in. female who on 09-NOV-2007 at 11:00 hours received her second dose of varicella virus vaccine live (Oka/Merck) (lot#659156/1367U). Concomitant vaccination included Fluzone (lot # U2476HA). There was no reported illness at the time of vaccination. On 09-NOV-2007, after receiving the vaccination, it was reported that the patient felt something shooting down her upper extremity, felt dizzy and was pale. Her pulse rate was reported as 80 to 90 with a blood pressure of 60/42. A repeat blood pressure in 10 minutes was 72/48. After 15 minutes, her blood pressure was 90/70. Reported treatment measures were oral fluids (water) and to rest. It was reported that she left the physicians office after about 30 minutes. It was reported she presented on 10-NOV-2007 to the physicians office with dizziness. It was reported that on 10-NOV-2007, her blood pressure was 80/60. Follow up information from the physician indicated that on 15-NOV-2007, she had recovered. A product quality complaint was not reported. Additional information has been requested.				Y					Y	11/09/2007	11/09/2007	0	blood pressure 11/09/07 60/42 - right after vaccination; blood pressure 11/09/07 72/48 - repeat after 10 min.; blood pressure 11/09/07 90/70 - after 15 min; blood pressure 11/10/07	PVT	PUB			Unknown		WAES0711USA03295	1						1	Blood pressure decreased; Dizziness; Pain; Pallor	FLU3~SANOFI PASTEUR~U2476HA~3~UN~~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1367U~2~UN~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0314335	05/23/2008	TX	9.0			U	05/16/2008	Information has been received from a physician concerning a memo from their cooperate office regarding a nine year old patient who had received a varicella virus vaccine live (Oka/Merck) booster. It was reported that the patient developed a possible anaphylaxis reaction with wheezing, shortness of breath, facial edema, facial mottling, was stabilized and transported to the hospital. It was not specified if the patient was admitted. Current patient status was not reported. No product quality complaint was reported. Further information was not available. This is one of three reports from the same source. Additional information has been requested.				Y					U				Unknown	OTH	OTH	Unknown		Unknown		WAES0711USA03683	1						1	Dyspnoea; Face oedema; Livedo reticularis; Wheezing	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~~UNK~UN~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0314336	05/23/2008	TX	9.0			U	05/16/2008	Information has been received from a physician concerning a memo from their cooperate office regarding a nine year old patient who had received a varicella virus vaccine live (Oka/Merck) booster. It was reported that he developed a possible anaphylaxis reaction with wheezing, shortness of breath, facial edema, facial mottling, was stabilized, and transported to the hospital. It was not reported if the patient was admitted. Current patient status was not reported. No product quality complaint was reported. Further information was not available. This is one of three reports from the same source. Additional information has been requested.				Y					U				Unknown	OTH	OTH			Unknown		WAES0711USA03684	1						1	Dyspnoea; Face oedema; Livedo reticularis; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~~UNK~UN~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0314348	05/23/2008	CA	72.0	72		F	05/16/2008	Information has been received from a health professional concerning a 72 year old 159 lb. 67 1/2 in. female with a history of allergies to Relafen who 10 days ago (17-OCT-2007), was vaccinated with a single dose in the right deltoid of varicella virus vaccine live (Oka/Merck) (lot#/ 658287/1173U), but was supposed to have been given zoster vaccine live (Oka/Merck). Concomitant vaccination included a dose in the left deltoid of Fluzone (lot# U2441AA). There was no reported illness at the time of vaccination or adverse events following prior vaccination. It was indicated that the patient did not develop any adverse experience as a result of the vaccination. There were no relevant diagnostic tests or laboratory data. Medical attention sought and current patient status was not reported. A quality complaint was not reported. Additional information is not expected.									U	10/17/2007	11/09/2007	23	None	PVT	PVT		Hypersensitivity			WAES0711USA03991	1						1	No adverse event; Wrong drug administered	FLU3~SANOFI PASTEUR~U2441AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1173U~UNK~UN~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0314819	05/23/2008	NE	74.0	74		F	05/16/2008	Information has been received from a registered nurse concerning a 74 year old female with no pre-existing allergies, birth defects, medical conditions, who on 12-OCT-2007 at 9:30 AM was vaccinated IM in the left arm with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot number: 658965/1355U) instead of zoster vaccine live (Oka/Merck) (MSD). Concomitant therapy included: pneumococcal 14v polysaccharide vaccine (lot number:651357/0391F) (MSD) SC in the right arm; Fluzone (lot number U244288) IM in the left deltoid. It was not considered to be a product confusion by the office. The nurse that gave the varicella virus vaccine live (Oka/Merck) was new and made a nursing error. No symptoms or problems note. No further information available. Unspecified medical attention was sought. There were no relevant diagnostic tests and laboratory data. There was no illness at the time of vaccination. There were no adverse events following prior vaccinations. The outcome was reported as recovered. There was no product quality complaint. Additional information has been requested.									Y	10/12/2007	10/12/2007	0	None	PVT	PVT			None		WAES0710USA02965	1						1	Incorrect route of drug administration; No adverse event; Wrong drug administered	FLU3~SANOFI PASTEUR~U244288~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~0391F~2~SC~RA~PNEUMO (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~1355U~UNK~IM~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0315160	05/23/2008	WV				F	05/16/2008	Information has been received from a female patient with a history of cervical cancer who was vaccinated with varicella virus vaccine live (Oka/Merck) at a free clinic several years ago and had a breakthrough of varicella. Concomitant vaccine included influenza virus vaccine (unspecified). The patient also developed the flu after receiving the flu vaccine. Unspecified medical attention was sought. The caller could not provide any additional information at this time. No product quality complaint was involved. No further information is available.				Y					U				Unknown	OTH	OTH			Cervical cancer		WAES0706USA05258	1						1	Influenza; Varicella post vaccine	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~~UNK~UN~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0315487	05/23/2008	CO	12.0	12		M	05/16/2008	Information has been received from a health professional concerning a 21 year old male with developmental delay, sulfonamide allergy, and allergies to Tegretol, Dilantin, Rocephin, a history of spastic retro ganglion who on 04-SEP-1997 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 623129/0550E) and a second dose of M-M-R II (lot #619236/006E). On 10 OCT-1997, the patient was vaccinated subcutaneously into the right arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 622968/0686E) and a Flu Vaccine in the left arm, (Lot # 7t81898). Concomitant therapy included Singulair, Levoxyl, dietary supplement (unspecified), and unspecified anti-seizure medication. On 8 FEB 2007, a varicella titer was obtained. The results, show antibody not detected. No adverse experience is related to this event. Medical attention was sought. The plan is to have the patient return for a Varivax.				Y					U	10/10/1997			serum varicella zoster 02/08/07 - negative	PVT	PVT	anti-seizure medication (therapy unspecified); dietary supplement; Levoxyl; Singulair	Developmental delay; Sulfonamide allergy; Drug hypersensitivity; Convulsion	Ganglion		WAES0704USA01226	1						1	Antibody test negative; Varicella zoster serology negative	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~~1~SC~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0315715	05/23/2008	NJ	1.3	1	.3	M	05/16/2008	Information has been received from a registered nurse concerning a 20 month old white male 23 lbs., 32 inches, who on 04-DEC-2006 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #654528/1044F). Concomitant therapy included influenza virus split virion 3v vaccine inactivated (FLUZONE (influenza virus split virion 3v vaccine inactivated)) and measles-mumps-rubella vaccine (M-M-R II). On 24-APR-2007 the patient experienced maculo-papular lesions on the abdomen and groin. Subsequently, the patient recovered from maculo-papular lesions on the abdomen and groin. The patient was seen by a physician and treated with Calamine and Benadryl. The patient was 6 lbs. 12 oz. at birth and has no siblings. No further information is available.				Y					Y	12/04/2006	04/24/2007	141	Unknown	PVT	PVT			Unknown		WAES0705USA00470	1						1	Rash maculo-papular	FLU3~SANOFI PASTEUR~~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0950F~1~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1044F~1~SC~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0315782	05/23/2008	NY	5.0	5		F	05/14/2008	This case was reported by a consumer and described the occurrence of swelling injection site in a 5-year-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. Previous and/or concurrent vaccination included influenza virus vaccine given on 21 November 2007. On 21 November 2007 at 14:00 the subject received 1st dose of Infanrix (unknown, right arm). On 21 November 2007, 1 hour after vaccination with Infanrix, the subject experienced swelling injection site, injection site pruritus and mark at injection site approximately 2 inches by 1.5  inches. The immunization series was discontinued. The events of swelling injection site and injection site pruritus resolved after three days. The reporter was not certain the vaccine administered was Infanrix. At the time of reporting the mark at injection site was unresolved.				Y					N	11/21/2007	11/21/2007	0	Unknown	PVT	OTH		Unknown	Exposure to whooping cough		AC700158A	1						1	Injection site pruritus; Injection site rash; Injection site swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B051AA~1~UN~RL~DTAP (INFANRIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0313212	05/24/2008		4.0			M	05/24/2008	Left thigh 10 cm x 8 cm.  No pain with palpation but child states it hurts a little.  Treatment given to the child included Tlenol and Benadryl.									U					MIL	UNK						1						1	Injection site pain	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B073AA~UNK~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2506AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0805~UNK~SC~RL~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~1323F~UNK~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1000U~UNK~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0313214	05/25/2008	AZ	1.58	1	.6	M	05/25/2008	Had a febrile seizure within 24 hrs.  No focal source for the seizure identified.  Sent home with conservative treatment only.				Y					Y	05/21/2008	05/22/2008	1	No testing	PUB	UNK		Uncomplicated Upper Respiratory Infection	None			1						1	Febrile convulsion	DTAP~UNKNOWN MANUFACTURER~~UNK~~~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0313268	05/26/2008	LA	6.0	6		M	05/26/2008	Pt presented to office on 5/21/08 with hx of cold sx and rash all over x 3 days. Exam: 50-75 vesicular lesions scattered all over. No history of fever. Aveeno, Benadryl, Calamine recommended. No ASA. Isolate, recheck prn.				Y					U	10/23/2007	05/18/2008	208	None	PVT	PUB	None	Viral illness	None			1						1	Nasopharyngitis; Rash generalised; Rash vesicular	FLU3~SANOFI PASTEUR~U2437AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1247U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0313447	05/27/2008	NY	9.0	9		M	05/20/2008	Pt given Tdap on 11/23/07 - was 9 years old at that time.									Y	11/23/2007				PUB	PUB	albuterol inhaler	none				1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U2461AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB21AA~2~IM~RA~HEP A (HAVRIX)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B02BA~UNK~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0313450	05/27/2008	DC	41.0			M	11/01/2007	Sudden onset of decreased sensation and tingling in right cheek and upper lip. Felt like face went to sleep. Symptoms lasted 2-3 weeks. Developed new neurological symptoms in 6/07 after AVA. Dx'ed with MS in 9/07.				Y					Y	12/16/2006	01/20/2007	35	Feb 07 MRI of brain with GAD: slight microvascular ischemic foci central posterior apical parietal region; likely incidental	MIL	MIL	Multivitamins	None	Urticaria, tingling in throat within 1 hour of bug bite; Seasonal allergies			1						1	Multiple sclerosis; Neurological symptom; Nuclear magnetic resonance imaging brain abnormal; Paraesthesia; Paraesthesia oral; Sensory loss	FLU3~SANOFI PASTEUR~U2308AA~4~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0311902	05/28/2008	NY	62.0	62		M	05/01/2008	Nov. 15 neck pain, tingling fingers.  Nov 16, 17, 18 extreme pain, tingling feet.  Nov 19th ER.  Nov. 19-Dr.  Nov. 20-22-could not move.  Nov. 21st could not walk at all.  Nov. 22nd-taken to hospital - on ventilator.			Y	Y	Y	0	Y		N	11/05/2007	11/15/2007	10	Tests - hospital, at this time another hospital	PUB	PVT	FLOMAX	No	No - prostate enlargement			1						2	Asthenia; Dysstasia; Guillain-Barre syndrome; Mechanical ventilation; Muscle strain; Neck pain; Paraesthesia; Pneumonia; Abasia; Laboratory test; Mechanical ventilation; Movement disorder; Neck pain; Pain; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80684~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|UNK~UNKNOWN MANUFACTURER~~UNK~UN~LA~VACCINE NOT SPECIFIED (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation	Influenza
0313723	05/28/2008	NY	44.0	44		F	05/23/2008	Initial report was received from a health care provider on 04 January 2008. A 44-year-old female patient had received an intramuscular left deltoid injection of FLUZONE NO-PRESERVATIVE 2007-2008, lot number U2475KA, and on the day of vaccination, she complained of pain at the injection site. Two days later, the pain became severe. Corrective treatments consisted of MOTRIN. On 20 December 2007, the patient received a physician's evaluation and subsequent x-ray with negative results. According to the reporter, it was possible that the vaccine may have been administered too high in the shoulder area, possibly into the bursa. At the time of the report, the pain intensity was mild and the patient reported a shooting pain through the arm when the shoulder was abducted. The patient had pre-existing allergies to penicillin, amoxicillin and CECLOR and had not been ill at the time of vaccination. Concurrent medications included VITORIN. At the time of the report, the patient had not recovered from the event. Follow-up information was received 14 May 2008 from a health care professional. According to the reporter, the patient had no history of arm pain. The pain at the injection site began immediately after vaccination and was severe for two days (previously reported as two days later, pain became severe). The pain was located high on the patient's left arm just below the joint. An X-ray of the patient's left shoulder was performed with negative results; no bone or joint abnormalities and no soft tissue calcification were seen. The patient was evaluated by a specialist and diagnosed with Subacromial Bursitis and soft tissue inflammation secondary to FLUZONE. She had been evaluated by the specialist on 04 January 2008, 21 January 2008 and 18 February 2008 (evaluation results not reported). On 06 May 2008, the patient reported to their health care provider that their arm is good now, sometimes hurts to lift, still tender to touch. No further information was provided at the time of the report.				Y					N	11/15/2007	11/15/2007	0	X-ray of left shoulder (negative) - no bone or joint abnormality and no soft tissue calcification.	PUB	PUB	VITORIN		The patient had a history of allergies to penicillin, amoxicillin and CECLOR and had not been ill at the time of vaccination.  Concomitant medication included VITORIN.  The patient had no history of arm pain.		200800024	1						1	Bursitis; Drug administered at inappropriate site; Immediate post-injection reaction; Injected limb mobility decreased; Injection site pain; Pain; Soft tissue inflammation; Tenderness; Vaccination complication; X-ray limb normal; Bursitis; Drug administered at inappropriate site; Immediate post-injection reaction; Injection site pain; Pain; Pain in extremity; Soft tissue inflammation; Tenderness; X-ray normal	FLU3~SANOFI PASTEUR~U2475KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2475K~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0313811	05/28/2008	TN	4.0	4		F	04/10/2008	After leaving clinic, child's right arm was swollen with a nodule where an immunization was given, broke out with hives on trunk, back, arms; was taken to ER and given BENADRYL, no circled nodule to watch how large it got; right arm was red, hot and swollen				Y					Y	02/05/2008	02/05/2008	0	Mother reported they did blood work at hospital and physician said it was caused by Tetanus vaccine but Td was given in left arm	PUB	OTH					TN08013	1						1	Blood test; Injection site nodule; Injection site swelling; Rash	DTAP~SANOFI PASTEUR~C2606AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2242AA~4~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0873~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0283U~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0313814	05/28/2008	TN	70.0	70		F	02/29/2008	Redness, swelling, and warmth at injection site. Left deltoid - more than normal									U	02/28/2008	02/28/2008	0	None	PUB	PVT	Prilosec	none	Sulfa allergy, ASA, Levaquin		TN08006	1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2511AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0313816	05/28/2008	TN	41.0	41		F	01/31/2008	Vaccines administered on 1-25-08. Patient went to ER that evening for swelling at injection site and redness on upper arm.				Y					Y	01/25/2008	01/25/2008	0		PUB	PUB	Benadryl, Clindamycin (Did not take)	None	Allergy: PCN/Codeine (GI upset), DM2, GERD		TN08002	1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2514AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1380U~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0313818	05/28/2008	NY	1.01	1	.0	M		The adverse symptoms my child received after the MMR injection was a huge rash all over his body then 5-days later, loss of speech & gastrointestinal difficulties, & loss of social withdrawal-autism.  5/29/2008 Multidisciplinary eval received dated 3/31/2008 with DX:  Speech Delay, Developmental Delay, PDD-Nos. On the Bayley Scales of Infant Development pt scored in the upper limit of moderately autistic range of autism spectrum disorders. Initially referred due to lack of speech aquisition (report states child has had no meaningful speech) but also had cognitive and social abnormalities.  /20/2008 Office records received from PCP with normal WCC 10/25/06. on 5/3/07 WCC Assessment:Well child. WCC 10/29/07 with vocab of 10 words at 2 yr check. Language delay noted at 2/28/08 visit. Follow-up: The residual symptoms that are related to the vaccine shot patient received are loss of speech and a regressive developmental disorder. Patient has pervasive developmental disorder not otherwise specified <PDD-NOS> known as autism spectrum. Patient received one hundred and twenty-five times his allowable exposure to mercury from vaccines in a single day.								Y	N	10/25/2006	10/30/2006	5	Labs and Diagnsotics: Audiology exam WNL.  Vitamin B12 >2000	PVT	PUB	PPD, 30722, left	none	Autism-mild - PDD. Family hx of speech delay			1						1	Autism; Gastrointestinal disorder; Rash generalised; Social avoidant behaviour	FLU3~SANOFI PASTEUR~U2244AA~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0804F~UNK~UN~LL~HEP A (VAQTA)~1|MMR~MERCK & CO. INC.~1117F~UNK~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Disabling	Influenza
0313870	05/28/2008	TX	4.0	4		F	05/28/2008	Patient began having seizures very soon after being given shots. Her attitude and demeanor changed immediately after shots. She became angry, hostile and unhappy. She was hospitalized for eight days on November 10th. The seizures started within a day or two after receiving shots, but I can not give the exact date, because I did not realize what was happening to her until the 10th of November. She has been on anti seizure medication since November 11 2007. The seizures are not stopping, but seem to be getting worse. Her doctors can find no cause for the seizures. We have had CT scans and MRI's. I have no doubt in my mind that her seizures were caused by these immunizations.  6/20/08 Reviewed hospital medical records of 11/13-11/17/2007. FINAL DX: complex partial epilepsy left posterior Records reveal patient experidnced new onset of seizures over approx 2-4 weeks.  Symptoms included: staring eyes, head tilted, smiling, arms extended, unable to communicate lasting approx 1 min.  On day before admission had 14 seizures.  Headaches & stomachache x 2-3 mos.  Seen at outlying hospital & multiple meds tried unsuccessfully.   8/5/08 Reviewed initial hospital medical records of 11/10-11/13/2007. FINAL DX: seizure disorder Records reveal patient experienced 2 episodes at home of staring & non-responsive each lasting approx 1 min.  Additional episodes observed in ER.  Started on antiseizure meds.  Continued w/seizure like activity.  Transferred to higher level of care for peds neuro consult.   1/21/2010 Patient continues to have siezures daily. She is taking 4 anticonvulsant medications.			Y	Y	Y	8			N	10/31/2007	10/31/2007	0	LABS: CT of head WNL.   EEG abnormal.  Brain MRI WNL except for bilateral paranasal sinus disease.	UNK	UNK		NONE	NONE  PMH: birth hx 38 wk vaginal delivery; mom used phenergan throughout pregnancy for N/V.  Perinatal jaundice.  Laryngomalacia resolved by 18 mos.  Recurrent colds w/fever.  Family hx: migraines, seizures			1						1	Abnormal behaviour; Anger; Communication disorder; Computerised tomogram; Convulsion; Hostility; Immediate post-injection reaction; Nuclear magnetic resonance imaging; Sinusitis; Transaminases increased	DTAP~SANOFI PASTEUR~C2797AA~5~IM~UN~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2445AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0923~4~IM~UN~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0289U~2~IM~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Life Threatening,Hospitalisation	Influenza
0314038	05/29/2008		37.0			M	05/27/2008	Initial information received on 15 May 2008 from a literature article.  The following case report information is verbatim from the literature article.  We present a patient who developed an immediate systemic anaphylactic reaction to the inactivated FLUZONE.  A 37-year-old male returned to the immunization clinic complaining of a warm sensation over his entire body 15 minutes after receiving a 0.5-ml intramuscular injection of FLUZONE; Aventis Pasteur.  He also experienced face tingling and redness, pruritis, postnasal drip, and lip numbness.  He had a localized cutaneous reaction at his right deltoid injection site.  He denied chest tightness, shortness of breath, and wheezing.  Based on his symptoms, he was given 10 mg of cetirizine and observed.  Over the next 15 minutes he developed lip swelling, worsening facial flushing, and heartburn with audible belching.  He was then treated with 0.3 ml of epinephrine intramuscularly and 150 mg of ranitidine orally.  His symptoms resolved over the next 30 minutes.  His past medical history was significant for a 4x4 cm right arm localized reaction to FLUZONE (unknown manufacturer) given four years prior that occurred within 15 minutes.  He had received other immunizations in the past without any adverse effects.  He denied food allergies including eggs and gelatin.  The FLUZONE vaccine that our patient received contained hemagglutinin representative of the three relevant influenza strains.  It was prepared from influenza viruses propagated in chicken eggs.  It also contained 0.5% gelatin (0.025 mg) which acts as a stabilizer and the preservative thimerosal, a mercury derivative at 25 micrograms of mercury per dose.  As part of his evaluation, the patient returned to the clinic on a separate day for skin prick testing.  He was skin tested to FLUZONE, native egg (white, yolk, and whole) and gelatin (Jell-O sugared gelatin, Kraft Foods).  His skin testing response to FLUZONE was positive (3 x 4 mm wheal and 5 x 7 mm flare), gelatin was positive (3 x 4 mm wheal and 5 x 5 mm flare) and egg was negative (egg white: 0 x 0 mm wheal and 4 x 4 mm flare; egg whole: 2 x 2 mm wheal and 3 x 3 mm flare, and egg yolk: 2 x 2 mm wheal and 4 x 4 mm flare).  His histamine-positive control was 4 x 5 mm wheal and 26 x 30 mm flare, and the diluent negative control was 0 x 0 mm wheal and 0 x 0 mm flare.  Results of concomitant gelatin skin tests on 2 control subjects (clinic staff) were negative (0 x 0 mm wheal and 0 x 0 flare).  Immunocap specific IgE testing to egg (white, whole, and yolk) and gelatin were negative (<0.35 kU/l).  IgE immunoblots were performed with 2 cord blood serums and the patient's serum at a 1:20 dilution against 20 micrograms of the FLUZONE.  The patient's IgE immunoblot showed a protein band at 100 kDa which is similar to the molecular weight of gelatin protein, a 68 kDa protein which is similar to the molecular weight of hemagglutinin protein from FLUZONE, and a 45-kDa protein band that is similar to the molecular weight of ovalbumin protein from chicken embryo/egg.  These IgE immunoblot bands were not found on the 2 cord blood non-atopic serum specimens.				Y					Y					UNK	UNK			The patient's medical history was significant for a 4x4 cm right arm localized reaction to an influenza vaccine (unknown manufacturer) given four years prior that occurred within 15 minutes.  He had received other immunizations in the past without any adverse effects.  He denied food allergies including eggs and gelatin.	Local reaction~Influenza (Seasonal) (no brand name)~UN~0.00~In Patient	200801598	1						1	Anaphylactic reaction; Dyspepsia; Eructation; Erythema; Feeling hot; Flushing; Hypoaesthesia oral; Lip swelling; Paraesthesia; Postnasal drip; Pruritus	FLU3~SANOFI PASTEUR~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0314404	06/01/2008	NC	14.0	14		M	06/01/2008	DIAGNOSED WITH CIDP/GUILLIAN BARRE SYNDROME IN MAY 2003 HE RECEIVED THE MENINGITS  VACCINE IN NOVEMBER 2002. Confirmed with parent and vax record concurs Flu vaccine given 12/8/2003, not meningococcal. Onset of sx January 2004, not 2003 as originally reported. 7/14/2008 Death Cert received with Immediate COD listed as Chronic Inflammatory Demyelinating Polyneuropathy. 06/03/2008 MR received for DOS 1/23-28/2008 with D/C DX:  Neuropathy. 2' DX:  Tachycardia.  Respiratory Distress. Pt most recently presented to another facility in December 2007 with GI issues and increasing lower extremity weakness. Pt was discharged and was transferred for further evaluation due to progressive upper extremity weakness and dyspnea, as well as new onset urinary and fecal incontinence, orthostasis, decreased hearing and L hand pain. Pt had initially developed limb weakness and paresthesias 4 years ago. Testing showed widespread sensory motor polyneuropathy. DX: Presumed Chronic Inflammatory Demyelinating Polyneuropathy. Course has been slowly progressing over the years and has had multiple hospitalizations and rehabs. PE (+) for tachycardia, use of accessory muscles for breathing, tachypnea and decreased breath sounds. Bowel sounds decreased. Motor exam showed decreased bulk, tone and strength. Sensation decreased with no proprioception below the elbow. Pt txd with plasmapheresis IVIG over the years without response. Pt now with autonomic dysfunction. BIPAP improved overall energy level. Pt unable to return to rehab facility given questionable prognosis so pt was D/C to home. Per mother pt died at home on 2/17/2008. PMH since 2003: (CIDP dx 2004 with depression, anxiety, osteoporosis.  Sural nerve bx, OSA on CPAP, Recent Gastroenteritis.)	Y	02/17/2008	Y	Y	Y		Y	Y	N	12/08/2003	01/20/2004	43	Labs and Diagnostics:  EMG/NCS 1/24/08 showed widespread sensory motor neuropathy significantly worsened since 2004.  Swallow study shows mild/moderate aspiration risk.  Genetic testing showed several sequence variations of unknown significance. CSF culture (-). CSF glucose 61. CSF protein 47.  CSF lactic Acid 1.5. (N). CSF Pyruvic Acid 0.18 (N). ESR 22. Thymidine phosphorylase activity normal.	UNK	UNK	NONE	NONE	NONE. PMH:  typanostomy tubes, phimosis, GERD,.  Allergy to sulfa.			1						1	Chronic inflammatory demyelinating polyradiculoneuropathy; Death	FLU3~SANOFI PASTEUR~U1088AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0314447	06/02/2008	NE	0.6	0	.6	M	05/29/2008	Child had fever of 103deg - non-stop crying; red legs. on 2-14-08. Fever on 2-15-08 was 99deg - no longer crying - slept through night on 2-14-08.									Y	02/13/2008	02/13/2008	0		PUB	UNK		no	none			1						1	Crying; Erythema; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B133CA~2~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2481FA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF213AA~2~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C42993~2~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1393U~2~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0314574	06/02/2008	VI	1.5	1	.5	F	06/02/2008	Mom states that two days after receiving vaccines, child was hospitalized for vomiting, diarrhea, high fever and extreme drowsiness- The child remained in the hospital for two days. The child was also seen by a private pediatrician before and after hospitalization.  6/13/08 Reviewed hospital medical records of 4/12-4/13/08. FINAL DX: acute gastroenteritis; dehydration; leukocytosis w/neutrophilia. Records reveal patient experienced vomiting w/bilious emeis & abdominal discomfort x 2 days.  Seen by PCP & tx w/meds but no improvement.  Urine output decreased & oral intake reduced.  Tx w/IVF  & antiemetic meds.  Improved & d/c to home w/PCP f/u.				Y	Y	2			Y	04/10/2008	04/12/2008	2	Unknown  LABS: WBC 16, 000; neutrophil 82.2%, lymphocyte 13.7%.  Creatinine 0.0 (L), CO2 20.4 (L).  Blood, urine & stool c/s neg	PUB	UNK		none	none known  PMH: frequent cold s/s.  Family hx of allergies, asthma, diabetes & HTN			1						1	Diarrhoea; Pyrexia; Somnolence; Vomiting	DTAP~SANOFI PASTEUR~U2290AA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT2459KA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB211AA~1~IM~RL~HEP A (HAVRIX)~1	USA	Hospitalisation	Influenza
0297425	06/03/2008	AZ	2.0	2	.0	M	05/29/2008	Initial report was received 20 May 2008 from a health care professional. Additional information was received 22 May 2008 from the same health care provider. A two-year-old male patient, who was an identical twin born at 32 weeks gestation, had received a third dose, left thigh intramuscular injection of FLUZONE 2007-2008, lot number UT2474CA, on 13 November 2007 and two days later, on 15 November 2007, he was admitted to the hospital with an admitting diagnosis of seizures. The patient had previously received a second dose intramuscular right thigh injection of FLUZONE, lot number U2504AA on 10 October 2007 with no reported adverse events. According to the reporter, patient had a past medical history which included chronic development delay NOS, blindness/low vision with CVI and extropia (the patient wears glasses), primary cardiomyopathy NEC and gastroesophageal reflux disease which required a gastrotomy tube placement on 18 May 2006. The patient was also noted to have been stable and no longer taking any cardiac medications (Captopril and Carvedilol); both of these medications had been discontinued prior to 12 September 2006. The patient had been receiving concomitant medications which included OCUFLOX 0.3% SOLN, TAMIFLU 12 mg/ml SUSR, PROTONIX 20 mg TBEC, and REGLAN 5mg/mL SOLN (start and stop dates not reported). According to a patient admission notification report, the patient was admitted to the hospital on 15 November 2007 with an admitting diagnosis of seizures. According to a VAERS report filled by the reporter on 19 November 2007, the patient was admitted on 17 November 2007 for acute loss of consciousness; however, the patient has a twin sibling (case 2008-01661) who had been hospitalized on 17 November 2007 with an admitting diagnosis of acute loss of consciousness. The following information will include information obtained from medical records received from the reporter. The patient had been seen by his neurologist for a follow-up evaluation on 22 April 2008 with a chief complaint of nonconvulsive epilepsy. According to the patient's history recorded in the neurologist's clinic notes, the patient experienced an episode of nonconvulsive status epilepticus in November 2007 which occurred one to three days following vaccination. Follow-up EEG showed no electrographic seizures and essentially normal background with some slowing in the left temporal and frontal central regions. MRI showed right temporal lobe atrophic changes. Focal edema was also seen in the left thalamus. A comparison MRI In May 2006 suggested atrophic changes in the right temporal lobe also existed at that time. The thalamus, however, was normal. The patient's family history noted the patient had a twin sibling with the same condition, although that twin required a heart transplant. Multiple testing had been performed when the diagnosis was made (diagnosis not specified). Metabolic and mitochondrial abnormalities were considered, however a definite diagnosis had not been made. Current prescribed treatments included valproic acid 150 mg t.i.d. and according to the patient's mother, the patient had not experienced any seizures and no evidence of trance like behaviors. The patient was described as doing well and progressing, but was significantly delayed and functioned at a level between 6 months and one year of age. He had a G-tube and was only able to take small feeds orally. Physical examination findings noted during the patient's follow-up neurological assessment on 22 April 2008 indicated the patient was hypotonic, nonverbal, but made expressive vocalizations with different sounds, but no distinct consonants. He had significant drooling, occasional ocular flutter and poor visual fixation with no following observed. His right eye was patched for strabismus. Facial movements were full and symmetric. He had very low tone in his axial and proximal musculature, brisk reflexes, particularly in the lower extremities where clonus was elicited. The patient could not strongly plantar flex his toes. He sat in a tripod position only briefly and his arms extended fully in a prone position. The neurologist impression was nonconvulsive status epilepticus, global developmental delay, hypotonia, and cardiomyopathy. The recovery status of the patient pertaining to the event of seizure and nonconvulsive status epilepticus was not reported. Documents held by sender: clinical records, neurology consult. The reporter for this case is the same as for case 2008-01661.				Y	Y	0				11/13/2007	11/15/2007	2	EEG - no electrographic seizures; essentially normal background with some slowing in the left temporal and frontal central regions. MRI - right temporal lobe atrophic changes; focal edema was also seen in the left thalamus. A comparison MRI in May 2006 suggested atrophic changes in the right temporal lobe also existed at that time. The thalamus, however, was normal.	PVT	PVT	OCUFLOX; TAMIFLU; PROTONIX; REGLAN; VALPROIC ACID		The patient had no illness at the time of vaccination and had received a prior dose of FLUZONE on 10 October 2007. The patient had a past medical history which included development delay NOS, blindness/low vision, primary cardiomyopathy NEC and gastroesophageal reflux disease. The patient had a gastrotomy tube placement on 18 May 2006.	No adverse effect~Influenza (Seasonal) (Fluzone)~1~2.00~In Patient	200801660	1						2	Brain oedema; Clonus; Convulsion; Drooling; Dysphonia; Electroencephalogram abnormal; Epilepsy; Hyperreflexia; Hypotonia; Loss of consciousness; Nuclear magnetic resonance imaging brain abnormal; Speech disorder developmental; Status epilepticus	FLU3~SANOFI PASTEUR~UT2474C~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0314652	06/03/2008	IL				U	05/29/2008	SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received from another manufacturer (no case reference number provided) on 20 May 2008.  The other manufacturer received the report from a health care professional.  A patient (age and gender not reported) with no reported medical history, had received an injection of flu vaccine (unknown manufacturer) on an unspecified date.  The trade name and lot number for the product were not reported.  An unspecified amount of time later, the patient had a severe reaction.  Symptoms included closing of throat.  It was not reported whether the patient recovered from the event and no other information was provided.				Y										UNK	UNK			Not reported.		200801676	1						1	Pharyngeal oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0314659	06/03/2008	AZ	2.0	2	.0	M	05/29/2008	Initial report was received 20 May 2008 from a health care professional. Additional information was received 22 May 2008 from the same health care provider. A two-year-old male patient, who was an identical twin born at 32 weeks gestation, had received a third dose, left thigh intramuscular injection of FLUZONE No-preservative 2007-2008, lot number UT247CA, on 13 November 2007 and four days later, on 17 November 2007, he was admitted to the hospital with an admitting diagnosis of acute loss of consciousness. According to the reporter, the patient had no concurrent illness at the time of vaccination. The patient had previously received a second dose, intramuscular right thigh injection of FLUZONE SV, lot number UT504AA, on 10 October 2007 with no reported adverse events. The patient had a history of complete heart transplant, strabismus and cortical visual impairment, gastroesophageal reflux disease, microcephalus, infectious mononucleosis, general social/family, development delay and feeding problems. The patient also had a history of infectious mononucleosis which had resolved with Valcyte therapy (dates not provided). The patient had been receiving concomitant medications which included Magnesium Sulfate 4%, Ferrous Sulfate 15mg/0.6mL, REGLAN 5 mg/Ml, POLY-VI-SOL, PROTONIX 40 mg, PROGRAF 5 MG/Ml, sirolimus 1 mg/mL and VALCYTE 450 mg/tabs. According to medical records received, the patient was admitted to the hospital's critical care unit on 17 November 2007 with an admitting diagnosis of acute loss of consciousness. According to a VAERS report filled by the reporter on 19 November 2007, the patient had been admitted on 15 November 2007 for seizures; however, this patient has a twin sibling (case 2008-01680) who had been hospitalized on 15 November 2007 with an admitting diagnosis of seizure. The following information will include information obtained from medical records received from the reporter. The patient had been seen by his neurologist for a follow-up evaluation on 22 April 2008 with a chief complaint of nonconvulsive epilepsy; global developmental delay; hypotonia; an cardiomyopathy. According to the patient's history described in the neurologists clinic notes, the patient was treated in November 2007 for nonconvulsive status epilepticus. His original EEG showed nearly continuous seizures. Follow-up EEG showed some continued electrographic seizures. The seizures in November 2007 occurred following a vaccination. It was not known whether the seizures were provoked by the vaccination. There were no associated fevers. The patient had an identical twin. Both the reporter and his twin had an unknown syndrome with dilated cardiomyopathy, hyptonia, developmental delay and seizures. They were both evaluated and multiple tests for metabolic and mitochondrial disease were negative including mitochondrial mutation and deletions, skeletal muscle biopsies, and heart muscle biopsies. The patient had two older twins siblings (age 7, male and female) and an older 8 year old sibling, all whom were normal. The patient was noted to have an allergy to aspirin and ibuprofen. The mother of the patient was concerned about the patient's overall development and was not aware that they may not eventually catch up and be normal. No diagnosis had been made despite multiple tests. Chromosomal microarray testing had not been performed. Physical examination findings by the neurologist on 22 April 2008 revealed the patient appeared healthy but hypotonic. He was unable to support his weight even in a seated position. He had significant rounding of his back with unsupported sitting. He wore glasses and had a conjugated gaze. Fixation and following were evident and occasional ocular flutter was seen. He was able to reach his hands forward towards objects. He was not able to say words, but was able to make many sounds, some which seemed to have had emotional content. He was negative for consonant production. He laughed with tickling. Cranial nerves were grossly intact with full extraocular movements, equal and reactive pupils, midline tongue and palate, and full symmetric facial movement. Motor tone was very decreased throughout in the axial and proximal planes. Reflexes were brisk, particularly in the lower extremities. He was unable to tripod sit or support his weight in vertical standing. He had increased tone in the lower extremities with vertical positioning. He remained awake and alert with no abnormal movements or staring noted during the course of the examination. Current medications receive by the patient include valproic acid 150 mg t.i.d. and KEPPRA 350 mg b.i.d. The neurologist's impression: unidentified syndrome of global developmental delay, nonconvulsive epilepsy, cardiomyopathy, and hypotonia. The mother of the patient was concerned about his overall development and long-term expectations; she had thought some day they would catch up. The neurologist did not think that was likely, and had concerns that they would not have significant verbal communication or the ability to walk. The patient's recovery status pertaining to the event of seizure and loss of consciousness was not reported. Documents held by sender: clinical records, neurology consult. The reporter for this case is the same as for case 2008-01660.				Y	Y	0				11/13/2007	11/17/2007	4	EEG, showed nearly continuous seizures; Follow-up EEG, showed some continued electrographic seizures	PVT	PVT	magnesium sulfate 4%, ferrous sulfate, REGLAN, POLY-VI-SOL, PROTONIX, PROGRAF, sirolimus, VALCYTE		The patient had no illness at the time of vaccination and had received a prior dose of FLUZONE on 10 October 2007.  The patient had a past medical history of complete heart transplant (16/Feb/2006), strabismus, gastroesophageal reflux disease, microcephalus, infectious mononucleosis, general social family, development delay NOS and feeding problem (g-tube - oral aversion).  The patient had allergies to aspirin and ibuprofen.	No adverse effect~Influenza (Seasonal) (Fluzone)~2~2.00~In Patient	200801661	1						1	Convulsion; Electroencephalogram abnormal; Epilepsy; Hyperreflexia; Hypotonia; Loss of consciousness; Status epilepticus	FLU3~SANOFI PASTEUR~UT2474C~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0314735	06/03/2008	OH	52.0	52		F	05/21/2008	C/O pain LUQ and some in (L) axillary area and felt warm. Did not take temp. Started approximately 2 hrs following inj on 5/19. Continued 5/20, but lesser degree. Did not miss work.									Y	05/19/2008	05/19/2008	0	N/A	PVT	PVT	Synthroid, Zocor	None	Hypothyroidism			1						1	Abdominal pain upper; Axillary pain; Feeling hot	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLA205~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|YF~SANOFI PASTEUR~UF301AA~1~SC~LA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0314973	06/04/2008	OH	23.0	23		M	06/04/2008	Patient was administered Twinrix instead of Hep A. He had already completed his Hep B series in 1998.  No adverse events were reported.									Y	05/22/2008			N/A	PUB	PVT	NONE	NONE	NONE			1						1	No adverse event; Wrong drug administered	FLU3~SANOFI PASTEUR~U2527AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB116AA~1~IM~RA~HEP A + HEP B (TWINRIX)~1|TDAP~SANOFI PASTEUR~C2938AA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0315209	06/06/2008	GA	8.0	8		F	05/30/2008	Child received 2 Varicella vaccines. Presented today with >50 Varicella like lesions										10/22/2007	05/26/2008	217	None	PVT	PVT	None	None	None			1						1	Rash vesicular; Skin lesion	FLU3~SANOFI PASTEUR~U2469AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB200AA~1~IM~LA~HEP A (HAVRIX)~1	USA		Influenza
0315226	06/06/2008	GA	56.0	56		M	05/30/2008	Rash covering upper right arm & shoulder within 24 hrs of administration.  Inflamed, itchy & bleeding rash.  Treatment: antibiotics, antihistamine & topical lotion for itch.									Y	05/19/2008	05/20/2008	1	None	PUB	PVT	tuberculin skin test PPD, Aventis, C2807AA, lower L forearm, no previous doses	None	None			1						1	Haemorrhage; Inflammation; Pruritus; Rash pruritic	ANTH~EMERGENT BIOSOLUTIONS~FAV174~1~UN~RA~ANTHRAX (BIOTHRAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA049AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|SMALL~UNKNOWN MANUFACTURER~VV04003A~1~OT~LA~SMALLPOX (NO BRAND NAME)~1|TYP~SANOFI PASTEUR~A0522~UNK~UN~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0315315	06/06/2008	MS	58.0	58		M	06/07/2008	Patient complains of itching at injection site six weeks after injection. Patient states he scratches site at night when his shirt is off. States the site will not heal. Patient denies any other symptoms and states no treatment has been performed at present.									N	10/20/2007	12/01/2007	42	None	MIL	MIL	None	Patient denies	Allergies: PCN			1						1	Injection site pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLA063AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0324821	06/06/2008	WI	73.0	73		F		Flu shot October - 2007. March - 2008 - The arm where I got my shot was red and itch. 3 in dia for 2 weeks. There were 2 days I felt like flu. But no temp. 2 weeks after I came down with Bronchitis and Penomia. A very severe cough. I might not get the flu shot in 2008. 5/28/08 - Feel congested yet my nose feels stuffy.									U	10/25/2007	03/01/2008	128		PVT	UNK	None	None	None			1						1	Bronchitis; Cough; Influenza like illness; Injection site erythema; Injection site pruritus; Nasal congestion; Pneumonia; Respiratory tract congestion	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA043AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0315294	06/07/2008	OH	30.0	30		F	06/07/2008	PT RECIEVED FLUMIST ON 20 DEC 08 @ 1400. EXPIRIENCED HIVES APROX 6 HOURS AFTER VACCINATION. WHICH CONTINUE DAILY TO THIS DATE.									N	12/02/2007	12/02/2007	0		MIL	MIL		NONE	NONE			1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0315297	06/08/2008	NY	45.0	45		M	06/08/2008	Patient recieved Flumist three days prior to being deployed. He developed headache, fever and chill and a target shaped rash on his thigh while in transit. He also developed Bells Palsy and elevated liver enzymes and was treated for Lyme Disease with doxycycline. He was also treated with steroids for the Bells Palsy. His symptoms resolved.  7/15/08 Reviewed medical records & vax records. FINAL DX: Lyme disease, Bell's palsy Records reveal patient experienced severe HA, pain w/rash to left inner thigh x 9 days, posterior neck pain, fever & chills.  Seen in ER on 10/23/2007.  Tick bite on left thigh previously.  Exam revealed blanching erythematous circular lesion medial left thigh.  Dx w/Lyme disese & tx w/antibiotics.  10/31/2007 w/fever, chills, myalgias, HA cough.  Noted Bell's palsy s/s x 1 day which worsened.  Tx w/steroids.  Seen 11/07 w/Bells's palsy unable to fully close left eye, left facial weakness.  Symptoms resolved & LFTs returned to WNL by 3/2008.									Y	10/12/2007	10/21/2007	9	CXR- No acute process. c-reactive protein-neg. CMP with elevated liver enzymes now wnl, CBC wnl.  LABS: AST 81 (H), ALT 128 (H)	MIL	MIL	none	none known	none			1						1	C-reactive protein normal; Chest X-ray normal; Chills; Facial palsy; Full blood count normal; Headache; Hepatic enzyme increased; Lyme disease; Metabolic function test abnormal; Pyrexia; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500483P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0315639	06/09/2008	VA	8.0	8		M	06/09/2008	Vaccines given on 3/18/08 with no problems.  Mother brought child back to the health dept on 3/19/08 because child awakened with itching & redness on face with swollen eye lids.  Rash on no other part of body.  Mother gave benadryl at home with no improvement.									Y	03/18/2008	03/19/2008	1		UNK	UNK		none	seasonal allergies		VA08008	1						1	Erythema; Eyelid oedema; Pruritus; Rash	FLU3~SANOFI PASTEUR~U2435AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB171AA~1~IM~LA~HEP A (HAVRIX)~1	USA		Influenza
0315655	06/09/2008	OK	72.0	72		M	06/09/2008	According to the client, on 11/2/07 he received  flu vaccine IM.  11/4/07, hands began tingling.  After a few days, arms and legs were ached and on 11/13/07 he fainted.  He was taken to the local ER and was transferred to another hospital where he stayed for 5 weeks. He was then transferred to Rehab Unit and had therapy for 3 months. 6/30/08-records received for DOS 11/14-12/6/07-DC DX:Acute infective polyneuritis. Pneumonia due to Streptococcus, panic disorder with agoraphobia. Transferred to rehab. Presented with paresthesias in hands a few days after vaccination and 1 week later on 11/12/07-began having weakness in legs and subsequently fell and has been unable to walk. Arms weak. Neuro exam, general weakness, no fasciculations. HX of diarrhea several days prior to onset of symptoms. Treated with IVIG.  8/5/08-records received for DOS 12/6/07-01/08/08-DC DX: Guillain Barre syndrome with paralysis from neck down with improvement. Involvement of upper and lower extremities and swallowing early on, at time of discharge slight movement of upper extremities and lower extremities.				Y	Y	54	Y		Y	11/02/2007	11/13/2007	11	6/30/08-records received-Chemistries basically normal, cardiac enzymes normal, white count 13,100 with normal differential. CT normal, MRI brain mild sinusitis. CXR, some pleural fluid. 8/5/08-records received-CXR-pneumonia.	UNK	UNK		None	None			1						1	Pain; Pain in extremity; Paraesthesia; Syncope	FLU3~SANOFI PASTEUR~U2508AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0315664	06/09/2008	WI	65.0	65		F	02/26/2008	Few hours after vaccines, pt's (R) arm became very painful. Pain also wrapped around chest/back. Pt unable to move arm 2 degrees. Pain began to resolve in < 24 hrs and completely symptom free within one week.									Y	11/08/2007	11/08/2007	0	None	PVT	OTH	Loratadine, MVI, Omega 3, Ginseng, Albuterol, ASA, Refresh eye drops, Meclizine; Lactobacillus	None	Allergic rhinitis, pulmonary emphysema, osteopenia, basal cell carcinoma, squamous cell carcinoma, lung nodules			1						1	Back pain; Chest pain; Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2440AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~1406F~1~IM~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0315719	06/09/2008	GA	86.0	86		M	12/20/2007	Pt had received a flu vaccine on 10/05/07 and was administered a flu vaccine on 12/19/07; pt was in clinic for TST.									U	12/19/2007				PUB	PVT	Tuberculin PPD, Parkdale, 39147, SD LFA, no previous doses	None			GA08031	1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U257AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0315724	06/09/2008	GA	45.0	45		M	04/01/2008	None.  Given Tdap vaccine.  Not licensed for this age.									U	01/11/2008				PUB	PUB					GA08023	1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U2507AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0090U~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B021AA~1~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0315729	06/09/2008	GA	44.0	44		F	03/07/2008	Pt noticed swelling & itching in Lt arm around site of injection 1 day after receiving vaccine.  The swelling & redness have enlarged to include entire upper left arm at 3 days post vaccination.  Pt was referred to MD.				Y					Y	02/29/2008	02/29/2008	0	None-pt went to ER 3/7/08 but did not want to see MD.  Went home -> took BENADRYL and swelling went away.  Seen by MD on 3/10/08 & put on medication to continue x1 week.  No other follow up recommended.	PUB	PUB	None	No	None		GA08017	1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78476~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C2844AA~1~UN~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0315721	06/10/2008	GA	78.0	78		F	11/20/2007	Pt. showed me L upper arm on 11-18-07, Sunday.  L upper arm had splotchy red area about the size of a nickel scattered over upper portion of arm.  States she went to ER the night she got the shots with fever and shaking.  Temp. was 100.2.  No fever on 11-18-07.				Y					Y	11/16/2007	11/16/2007	0		PUB	PUB	LIPITOR	None	None		GA08027	1						1	Injection site erythema; Nervousness; Pyrexia; Rash macular	FLU3~SANOFI PASTEUR~U2507AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0601F~2~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~MASS. PUB HLTH BIOL LAB~TD159~1~IM~RA~TD ADSORBED (TDVAX)~1	USA	Emergency room visit	Influenza
0316006	06/11/2008	IN	32.0	32		M	06/11/2008	Pt describes like a heat rash that started around both wrists about 2 days after vaccine receipt.  Received multiple vaccines on Saturday (5/3/08) and rash appeared on Monday (5/5/08) as well as his wife noted that his right eye was little puffy.  Pt said by Wednesday (5/7/08), the right side of his face was swollen and his right eyelid was almost swollen closed.  He still had a rash on his arms and also had a rash around his right eye and on the right side of his nose.  He denies any local reactions.  (Some of vaccines given in right upper arm and remainder given in left upper arm.)  He denies any fever, chills, joint pain, headaches, fatigue, rhinorrhea, itchy or swollen throat, swollen tongue, difficulty swallowing, dyspnea, cough, sneezing or wheezing.  No visual changes, facial drooping or slurred speech.  Pt went to his local doctor on Wednesday (5/7/08) and received a steroid shot and was prescribed a MEDROL pack and ZYRTEC.  The right sided facial swelling was completely gone by Saturday (5/10/08) and the rest of his symptoms resolved by the following Monday (5/12/08).  He denies any exposures around time of vaccines like yard or work-related chemicals, detergents, bug sprays, soaps, insect bites, new foods, cleansers, lotions, new clothing or bed linens, or household chemicals.  No history of similar rashes or adverse vaccine reactions.  Will not be deploying until April 2009; will not have drill until Sept 2008.  Pt currently has no symptoms.				Y					Y	05/03/2008	05/05/2008	2	None	MIL	MIL	None	None	NKDA			1						1	Eye swelling; Eyelid oedema; Rash; Swelling face	ANTH~UNKNOWN MANUFACTURER~~UNK~SC~UN~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~IM~UN~HEP A (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~SC~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0316056	06/11/2008	CA	12.0	12		M	05/20/2008	None stated									Y	11/26/2007	11/26/2007	0	None	PVT	PVT			On 26 November 2007, the patient had no illnesses, pre-existing medical conditions, and use of other medications. The patient had not experienced any adverse events with prior vaccinations, and had not received any other vaccinations within four weeks of 26 November 2007.		200704074	1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|MNQ~SANOFI PASTEUR~U2419A~UNK~IM~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0316130	06/12/2008	IL	50.0	50		F	06/12/2008	patient complaining of arm soreness after receiving the flu vaccination on 11/07/2007. Patient made pharmacy aware on 6/9/08.									U	11/07/2007				UNK	PVT						1						1	Pain in extremity	FLU3~SANOFI PASTEUR~42514aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0316234	06/13/2008	AR	70.0	70		F	06/13/2008	redness at injection site at day 7 after injection										06/06/2008	06/13/2008	7		PVT	PVT		spleenic mass-				1						1	Inappropriate schedule of drug administration; Injection site erythema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA093AA~UNK~IM~GM~INFLUENZA (SEASONAL) (FLULAVAL)~1|MNQ~SANOFI PASTEUR~U2614AA~UNK~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PPV~MERCK & CO. INC.~0380U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0266744	06/16/2008	NY	74.0			M	06/13/2008	Information has been received from a 74 year old male consumer and a pharmacist with adverse drug reaction to unspecified medications, a cardiac disorder (also reported as coronary artery disease), chronic sinusitis, hypercholesterolaemia, hyperlipidaemia and drinks socially 2 to 3 times per week and a history of colon polyps, excision of fatty tumor at the ear, pilonidal cyst removal, an an ex-smoker (cessation 5 years ago) who in 2005 was vaccinated with PNEUMOVAX 23 (manufacturer unknown). On 24-OCT-2006, the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot# 655054/0749F). Concomitant therapy included influenza virus vaccine (unspecified) and an unspecified heart medication, AVAPRO, COREG, LOVAS and PLAVIX. On 24-OCT-2006, in the evening, the patient started to swell up after receiving the PNEUMOVAX 23 vaccine and hypertension (The patient also reported that currently his blood pressure was going up). The patient reported that he had to take 40 antibiotics for 10 days. On 21-MAY-2008 (also reported as the end of May), he developed pneumonia and was hospitalized from 21-MAY-2008 to 26-MAY-2008. The patient had blood chemistry and hematology lab work during the emergency visit. At the time of this report, the patient had not recovered. Additional information has been requested.					Y	5	Y		N	10/24/2006	10/24/2006	0	blood chemistry, 05/21?/08; hematology, 05/21?/08	OTH	OTH	[therapy unspecified]; COREG; PLAVIX; AVAPRO; LOVAS (LOVASTATIN)	Adverse drug reaction; Hyperlipidaemia; Social alcohol drinker; Chronic sinusitis; Hypercholesterolaemia; Cardiac disorder; Coronary artery disease	Myocardial infarction; Stent placement; Colonic polyp; Ear operation; Pilonidal cyst excision; Ex-Smoker		WAES0806USA01008	1						2	Haematology test; Hypertension; Laboratory test; Pneumonia; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0749F~UNK~UN~UN~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0316371	06/16/2008	IL	29.0	29		F	06/10/2008	320PM patient complained of thick, fuzzy tongue, speech clear, no shortness of breath, no cough. Patient complained of feeling weird, shakiness and heart racing. Adult epipen 0.3mg injected into right thigh, 911 called. Patient remained alert, oriented x3, and speaking clearly. Patient departed via ambulance to ER at 3:40PM.				Y					Y	06/10/2008	06/10/2008	0	Unknown	PVT	PVT	None	None	Bee stings, PCN, Ceclor, Amoxicillin, Erythromycin, Bactrim			1						1	Feeling abnormal; Palpitations; Tongue disorder; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA310AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|IPV~SANOFI PASTEUR~A0298~1~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|TYP~SANOFI PASTEUR~A0394~1~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0316421	06/17/2008	IL	26.0	26		F	06/13/2008	This case was received from a consumer on 03 June 2008.  A 26-year-old female patient, with no medical history, received a first injection of FLUZONE (lot number U1128AA) on 15 November 2003.  In December 2003, the patient reported feeling unwell.  On 02 December 2003, she experienced a fever of 102 degrees.  Subsequent laboratory testing revealed elevated liver enzymes; per the patient, her blood work was all off.  A liver biopsy was negative for auto immune attacks, and a bone marrow biopsy was negative for leukemia and lymphoma.  According to the reporter, the event had resulted in prolongation of hospitalization.  The event had not yet resolved.					Y	0	Y		N	11/15/2003	12/01/2003	16	Liver biopsy negative auto immune attacks; Bone marrow biopsy negative leukemia/lymphoma	UNK	UNK			No medical history, no illness at time of vaccination.		200801851	1						1	Biopsy bone marrow normal; Biopsy liver normal; Hepatic enzyme increased; Malaise; Pyrexia	FLU3~SANOFI PASTEUR~U1128A~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0316432	06/17/2008	WA	81.0	81		M	06/16/2008	Patient complains of arm pain from shoulder to wrist since day of getting vaccinated.									N	11/12/2007	11/12/2007	0		OTH	OTH	Lipitor; Omoprazoll					1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2515AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0316500	06/18/2008	IL	19.0	19		M		See copy of medical records for initial visits.  Patient was admitted to hospital and still an inpatient as of 5/13/08.  DX: GBS.  Hospital progress notes also attached.  7/22/2008 MR received for DOS  3/03-5/23/2008 with D/C DX: Guillain-Barre Syndrome. 2ndary DX:  SIADH, constipation, R hand 5th metacarpal fracture and depression. Pt presented on 3/3/08 with 4 day hx of progressive ascending numbness and motor weakness which began at the ankles to the upper extremities. Pt developed respiratory distress and decreased vital capacity and was intubated on 3/09/08 x 7 days and extubated. No further respiratory issues. Tx with IVIG. Pt then developed SIADH and was tx with fluid restriction. Pt showed some sensation and motor function improvement although now c/o depression and continued pain in the feet. Choriform movements noted by neurology and tx with clonazapam with resolution of sx. Pt developed bilateral ankle contractures. D/C 5/23/08 to continue outpt rehab.					Y	80			U	01/29/2008	02/29/2008	31	Labs and Diagnostics: CSF-no oligoclonal bands. CSF albumin 49.7. CSF IGG synthesis high at 4.7. CSF protein 79.3. CSF cx (-), otherwise WNL.  CXR (+) for infiltrates in the L perihilar region	MIL	MIL	BICILLIN	None	None			1						1	Guillain-Barre syndrome	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLA050AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB103AA~1~IM~RA~HEP A + HEP B (TWINRIX)~1|MMR~MERCK & CO. INC.~0868U~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|MNQ~SANOFI PASTEUR~U2566AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2775AA~1~IM~RA~TDAP (ADACEL)~1	USA	Hospitalisation	Influenza
0316501	06/18/2008	IL	19.0	19		M		See copy of medical records for initial visit. Patient was admitted in hospital. He is still hospitalized as of 5/7/08. Dx- Peripheral Nerve disease and peripheral sensory neuropathy. 7/21/08-Records received for DOS 4/26-5/9/08-DC DX:Guillain-Barre syndrome. AIDP and left facial palsy. Presented with numbness in both legs and hand  balancing problem, sensory changes numbness of abdomen, muscular weakness. One loose stool. Treated with IVIG. Transferred to rehab, stay complicated by left facial palsy on 5/4/08. PE: DTR decreased.					Y	13				03/14/2008	04/19/2008	36	7/21/08-records received-LP revealed increased protein 297.1, WBC 12.8, lymph% 90 and mono %10. CSF culture no organisms seen. EMG conduction block and mild prolongation of latency, findings are suggestive of acute demyelinating neuropathy though there is an axonal component as well. MRI brain/cervical spine unremarkable.	MIL	UNK	Bicillin	None 7/21/08-records received-preceded by URI symptoms for 3 weeks with cough, sputum yellow, runny nose, congestion	None			1						1	Areflexia; Asthenia; Dysaesthesia; Gait disturbance; Hyperaesthesia; Hypoaesthesia; Nervous system disorder; Paraesthesia; Peripheral sensory neuropathy; Balance disorder; Blood product transfusion; CSF culture negative; CSF lymphocyte count increased; CSF monocyte count decreased; CSF protein increased; CSF white blood cell count increased; Diarrhoea; Electromyogram abnormal; Facial palsy; Hypoaesthesia; Hyporeflexia; Lumbar puncture abnormal; Muscular weakness; Nuclear magnetic resonance imaging brain normal; Nuclear magnetic resonance imaging normal; Sensory disturbance	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA050AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB108AA~1~IM~LA~HEP A + HEP B (TWINRIX)~1|MMR~MERCK & CO. INC.~1311U~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|MNQ~SANOFI PASTEUR~U2570AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2864AA~1~UN~RA~TDAP (ADACEL)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA050AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~2|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB108AA~UNK~IM~LA~HEP A + HEP B (TWINRIX)~2|MMRV~MERCK & CO. INC.~1311U~UNK~SC~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~2|MNQ~SANOFI PASTEUR~U2670A~UNK~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TDAP~SANOFI PASTEUR~C2864A~UNK~UN~RA~TDAP (ADACEL)~2	USA	Hospitalisation	Influenza
0316502	06/18/2008	IL	20.0	20		M	05/07/2008	See copy of medical records for initial report.  Patient was admitted in hospital from 4/8 to 5/1/2008 with diagnosis of Peripheral nerve DOS and dysphagia. 7/21/08-records received for dates of service 4/16-5/1/08-DC DX:Guillain Barre syndrome, Acute inflammatory demyelinating polyneuropathy (AIDP). Right lower lobe pneumonia. Presented on 4/8/08 with parasthesias of upper and lower extremities, weakness of right upper extremity, generalised areflexia, tingling of hands and feet, evidence of bulbar involvement, weak cough, absent gag reflex, nasal twang, slurred speech. On admission C/O left upper extremity weakness. Treated with IVIG. Admitted to rehab with unsteady gait and residual slurred speech with mild dysphagia and near complete resolution of weakness in lower and left upper extremities. PE: DTR diminished.  This case was initially reported to the Centers for Disease Control and Prevention (CDC) by a health professional. The case was subsequently forwarded by the CDC, and was received on 15 September 2008. A 20-year-old male service member received the following vaccines on 21 March 2008: a left arm intramuscular injection of ADACEL (lot number C2869AA), an intramuscular left arm injection of MENACTRA (lot number U2567AA), a right arm injection of influenza vaccine (GlaxoSmithKline, lot number AFLLA050A), an intramuscular left arm injection of Hepatitis A and B vaccine (GlaxoSmithKline, lot number AHABB108AA), and a subcutaneous left arm injection of MMR II (Merck, lot number 0871U). On 05 April 2008, 15 days after vaccination, the patient began experiencing upper respiratory symptoms, including cough and runny nose. He was treated with Bicillin. On 08 April 2008 be presented to the hospital with paresthesias of the upper and lower extremities, weakness of the right upper extremity, generalized areflexia, tingling of the hands and feet, a weak cough, absent gag reflex, nasal twang, and slurred speech. In addition, there was also evidence of bulbar involvement, and physical exam demyelinating neuropathy. He was diagnosed with GUILLAIN BARRE Syndrome/acute inflammatory demyelinating polyneuropathy, and right lower lobe pneumonia. Treatment included IVIG (intravenous immunoglobulin therapy). According to medical records received by the CDC, the patient underwent a CT of the brain after undergoing a right temporal craniectomy. It revealed a large arachnoid cyst of right temporal region in right middle cranial fossa, compression deformity and atrophy of right temporal lobe, and shunting tube in arachnoid cyst. Additionally, the CT scan showed acute sinusitis. At the time of his transfer to a rehabilitation facility he had experienced near-complete resolution of weakness the lower and left upper extremities. He continued to have an unsteady gait and residual slurred speech mild dysphagia. 01/Dec/2008: Corrective version was created for the purpose of amending the ADACEL lot number in the product screen to C2869 (previously entered as C2864A). Follow-up information received on 25 March 2009 from the Centers FOR Disease Control and Prevention (CDC) (VAERS number 316502). The level to diagnostic certainty for this confirmed GBS case is level 2. Documents held by sender: None.					Y	15			U	03/21/2008	04/05/2008	15	7/21/08-records received-CT brain status post right temporal craniectomy: revealed a large arachnoid cyst of right temporal region in right middle cranial fossa. Compression deformity and atrophy of right temporal lobe. Shunting tube in arachnoid cyst. Acute sinusitis. EMG showed evidence of acute demyelinating neuropathy.	MIL	MIL	Bicillin	None 7/21/08-records received-Also presented with URI symptoms of cough and runny nose for 3 days prior to admission.	None; Three-day history of upper respiratory infection, including cough and runny nose. Arachnoid cyst, craniectomy, head injury, pharyngolaryngeal pain, ventriculo-peritoneal shunt.		200802882	1						1	Acute sinusitis; Areflexia; Asthenia; Cough; Craniectomy; Dizziness; Dysaesthesia; Dysarthria; Dysphagia; Dyspnoea; Fatigue; Hyperaesthesia; Malaise; Muscular weakness; Neuropathy peripheral; Pyrexia; Rhinorrhoea; Throat tightness; Upper respiratory tract infection; Wheezing; Areflexia; Blood product transfusion; Craniotomy; Demyelinating polyneuropathy; Dizziness; Dysaesthesia; Dysphagia; Electromyogram abnormal; Guillain-Barre syndrome; Scan brain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA050A~1~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB108AA~1~IM~LA~HEP A + HEP B (TWINRIX)~1|MMR~MERCK & CO. INC.~0871U~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|MNQ~SANOFI PASTEUR~U2567AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2869AA~1~IM~LA~TDAP (ADACEL)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLAO5GA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~2|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB1C8AA~UNK~IM~LA~HEP A + HEP B (TWINRIX)~2|MNQ~SANOFI PASTEUR~U2567A~UNK~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TDAP~SANOFI PASTEUR~C2864A~UNK~IM~LA~TDAP (ADACEL)~2	USA	Hospitalisation	Influenza
0316519	06/18/2008	PA	14.0	14		F	06/18/2008	headache earache upper respitory sore throat				Y					U	10/27/2007	10/27/2007	0	seen spec. dr.  e.n.t.	UNK	OTH	none	none	none	none~ ()~~0.00~Patient|none~ ()~~0.00~Sibling		1						1	Ear pain; Headache; Pharyngolaryngeal pain; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~u2462aa~1~ID~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0316525	06/18/2008	NY	62.0	61		F	06/18/2008	Patient claimed within 1 hours after receiving the flu vaccine experienced behavior changes, paleness, weakness, dizziness, sweating.									U	11/07/2007	11/07/2007	0		PVT	PVT	unknown	N/A	hx of + PPD, goiter			1						1	Abnormal behaviour; Asthenia; Dizziness; Hyperhidrosis; Pallor	FLU3~SANOFI PASTEUR~U2469AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0316530	06/18/2008	PA	45.0	45		F	06/18/2008	upper respitory  congestion-nose&chest headache facial pain				Y					U	10/27/2007	10/27/2007	0	I was on 3 very powerful drugs all these months following shot they did nothing  hosp.visit amoxicillin500mg,oxycodone325   before hosp.visit azithromycin250,fexofenadine180	UNK	UNK	avonex	none	multiple sclerosis	none~ ()~~0.00~Patient|none~ ()~~0.00~Sibling		1						1	Facial pain; Headache; Upper respiratory tract congestion	FLU3~SANOFI PASTEUR~u2462aa~2~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0316563	06/18/2008	IL	42.0	42		F	06/16/2008	Left arm brachial neuritis. Developed 4 days after receive annual influenza vaccine. Left arm weakness and pain. Currently taking pain medication (Lyrica, Tramadol). He has been in physical therapy 6/27/08 Reviewed clinic vax records & medical records 11/9/2007-5/19/08.   FINAL DX: left idiopathic brachial plexitis r/t influenza vaccination. Note of 11/9 reveals patient experienced left arm pain day after vaccination which continued to worsen w/decreased mobility & then unable to lift left arm.  Included left upper back, shoulder & deltoid aching & tingling w/occasional sharp shooting pain.  Had to use right arm to lift left arm above chest level.  Referred to neurology.  Very slowly improving w/meds & PT.									N	11/01/2007	11/05/2007	4	Electromyography studies 11/15/2007  LABS: EMG/NCS c/w idiopathic brachial plexitis	PUB	PVT	None	None	PMH: chronic upper back & neck pain, Allergic: red dye causes hives, feathers & Christmas trees.			1						1	Muscular weakness; Pain in extremity; Radiculitis brachial	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA298AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0262657	06/19/2008	CA	18.0			M	03/19/2008	Initial report received on 07 March 2008. Center for Disease Control VAERS ID# 262657. A search of the CDC VAERS database was completed on 13 March 2008 which also revealed additional information for this case. This case involves an 18-year-old male, whose past medical history included a cough, and exposure to other recruits with diarrhea, but no history of diarrhea since 02 August 2006. The patient has an allergy to Penicillin, but had no other illness, or past medical issues (specifically hypertension, thyroid disorder, diabetes, or epilepsy). He also had no caffeine, tobacco, or alcohol use. On 02 August 2006, the patient received a dose of MENOMUNE (lot#, route and site of administration not provided); a dose of MMR II (trade name, manufacturer name, route and site of administration not provided); a dose of pneumococcal vaccine (trade name, manufacturer name, route and site of administration not provided); and a first dose of TWINRIX (manufacturer GSK, route and site of administration not provided). On 29 August 2006 the patient subsequently received a first, subcutaneous, left arm dose of YF-Vax (lot #VEG01AA); a first, subcutaneous, right arm dose of IPOL (lot# Y1051); a first, intramuscular, right arm dose of ADACEL (lot # C2457AA); a first, intranasal dose of FLUMIST (lot # 500430P, manufacturer Medimmune Inc./Wyeth laboratories, Inc.); and a second, intramuscular, left arm dose of TWINRIX (lot # AHABB061AA, manufacturer GlaxoSmithKline). On 30 August 2006, the patient developed progressive ascending weakness in his hands and feet bilateral, with gait disturbance, numbness pins and needles, intermittent tingling of feet, and calf pains. He had no fever, rash, headache, stiff neck, diplopia, trouble breathing or swallowing, dysuria, or incontinence. Physical examination revealed an awake, alert and oriented patient. Examination of the neck was normal, and neurological examination revealed normal cranial nerves II-XII, no sensory abnormalities, normal muscle tone and bulk, and normal strength of face and neck/cervical spine. The patient had decreased strength of the upper (4/5) and lower (3/5) extremities. He had asthenia, was unable to walk unassisted, abnormal biceps and brachioradials (1+) reflexes, absent or diminished ankle jerk, and knee jerk was normal. The patient's toes were flaccid with Babinski testing. The patient was subsequently admitted to the intensive care unit in the hospital on 02 September 2006, and his respiratory status was monitored with frequent pulmonary function tests. He did not require inbation or other respiratory support. Treatment included HEPARIN, and IVIG 42 gm daily for three days. Diagnotic laboratory studies revealed a lumbar puncture test that was negative for albuminocytologic dissociation but cultures and PCR were pending at the time of this report. An EMG revealed electrophysiologic evidence of a severe motor, greater than sensory, acquired multifocal sensorimotor peripheral neuropahy with axonal, greater than demyelinating features. Per the reporter, given the history of the patient, this likely represented a variant of GBS. Yellow fever studies revealed evidence of recent vaccination with yellow fever vaccine. No yellow fever viral RNA was detected by Tag Man RE-PCR, and IgM Capture ELISA was negative for all serum samples. PRNI (+Control >2560) was <10 for serum sample #1, 10 for Serum sample #2, 10 for Serum sample #3, 20 for Serum sample ad, 20 for serum sample #5, 10 for serum sample #5. The patient was discharged after five days of hospitalization. Recovery status at the time of this report was unknown.					Y	5			U	08/29/2006	08/30/2006	1	Diagnostic laboratory studies revealed a lumbar puncture test that was negative for albuminocytologic dissociation. Cultures and PCR Initial report received on 07 March 2008 from the agency. Centers for Disease Control VAERS ID # 262657. A search of the CDC VAERS database was completed on 13 March 2008 which also revealed additional information for this case. This case involves an 18-year-old male, whose past medical history included a cough, and exposure to other recruits with diarrhea, but no history of diarrhea since arrival to the military base on 02 August 2006. The patient has an allergy to Penicillin, but had no other illness, or past medical issues (specifically hypertension, thyroid disorder, disease, or epilepsy). He also had no caffeine, tobacco, or alcohol use. On 02 August 2006, the patient received a dose of MENOMUNE (lot #, route and site of administration not provided); a dose of MMR vaccine (trade name, manufacturer name, route and site of administration not provided); a dose of pneumococcal vaccine (trade name, manufacturer name, route of administration not provided); and a first dose of TWINRIX (manufacturer GSK, route and site of administration not provided). On 29 August 2006 the patient subsequently received a first, subcutaneous, left arm dose of YF-Vax (lot # VE301AA); a first, subcutaneous, right arm dose of IPOL (lot # Y1051); a first, intramuscular, right arm dose of ADACEL (lot # C2457AA); a first, intranasal dose of FLUMIST (lot # 500430P, manufacturer MedImmune Inc./Wyeth laboratories, Inc. ); and a second, intramuscular, left arm dose of TWINRIX (lot # AHABB061AA, manufacturer GlaxoSmithKline). On 30 August 2006, the patient developed progressive ascending weakness in his hands and feet bilateral, with gait disturbance, numbness, pins and needles, intermittent tingling of feet, and calf pains. He had no fever, rash, headache, stiff neck, diplopia, trouble breathing or swallowing, dysuria, or incontinence. Physical examination revealed an awake, alert and oriented patient. Examination of the neck was normal, and neurological examination revealed normal cranial nerves II-XII, no sensory abnormalities, normal muscle tone and bulk, and normal strength of face and neck/cervical spine. The patient had decreased strength of the upper (4/5) and lower (3/5) extremities. He had asthenia; was unable to walk and knee jerk was normal. The patient's toes were flaccid with Babinski testing. The patient was subsequently admitted to the intensive care unit the hospital on 02 September 2006, and his respiratory status was monitored with frequent pulmonary function tests. He did not require intubation or other respiratory support. Treatment included HEPARIN, and IVIG 42 gm daily for three days. Diagnostic laboratory studies revealed a lumbar puncture test that was negative for albuminocytologic dissociation but cultures and PCR were pending at the time of this report. An EMG revealed electrophysiologic evidence of a severe motor, greater than sensory, acquired multifocal sensorimotor peripheral neuropathy with axonal, greater than demyelinating features. Per the reporter, given the history of the patient, this likely represented a variant of GBS. Yellow fever studies revealed evidence of recent vaccination with yellow fever vaccine. No yellow fever viral RMA was detected by Iaq Man RR-PCR, and IGM Captures ELISA was negative for all serum samples. PRNI (+Control <2560) was <10 for serum sample #1, 10 for Serum sample #2, 10 for Serum sample #3. 20 for Serum sample #4, 20 for serum sample #5, 10 for serum sample #5. The patient was discharged after five days of hospitalization. Recovery status at the time of this report was unknown.	UNK	UNK	None		The patient had no concurrent illness except for a cough and exposure to other recruits with diarrhea, but no history of diarrhea since arrival to the military base on 02 August 2006. Past medical history included allergy to penicillin, but no other illness, or past medical issues (specifically hypertension, thyroid disorder, diabetes, or epilepsy), and he had no caffeine, tobacco, or alcohol use.		200800753	1						2	Areflexia; Asthenia; Axonal neuropathy; Blood immunoglobulin M; Blood test normal; Dyskinesia; Electromyogram abnormal; Extensor plantar response; Gait disturbance; Hypoaesthesia; Hypotonia; Immunology test; Lumbar puncture normal; Muscular weakness; Pain in extremity; Paraesthesia; Peripheral sensory neuropathy; Physical examination normal; Areflexia; Asthenia; Babinski reflex test; Culture; Electromyogram abnormal; Gait disturbance; Grip strength decreased; Hypoaesthesia; Hypotonia; Immunology test; Immunology test normal; Joint range of motion decreased; Lumbar puncture normal; Muscular weakness; Neurological examination normal; Neuropathy peripheral; Pain in extremity; Paraesthesia; Polymerase chain reaction; Pulmonary function test; Viral test negative; Asthenia; Blood product transfusion; CSF cell count normal; CSF protein increased; Electromyogram abnormal; Fatigue; Guillain-Barre syndrome; Impaired work ability; Neuropathy peripheral; Pain in extremity; Quadriparesis; Abasia; Areflexia; Asthenia; Axonal neuropathy; Babinski reflex test; Blood product transfusion; CSF culture; Electromyogram abnormal; Gait disturbance; Grip strength decreased; Guillain-Barre syndrome; Hypoaesthesia; Immunology test; Intensive care; Lumbar puncture; Lumbar puncture normal; Muscular weakness; Pain in extremity; Paraesthesia; Peripheral sensorimotor neuropathy; Polymerase chain reaction; Pulmonary function test; Reflexes abnormal; Serology normal	FLUN3~MEDIMMUNE VACCINES, INC.~500430P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|IPV~SANOFI PASTEUR~Y1051~1~SC~RA~POLIO VIRUS, INACT. (IPOL)~2|TDAP~SANOFI PASTEUR~C2457AA~1~IM~RA~TDAP (ADACEL)~2|YF~SANOFI PASTEUR~VEG01A~1~SC~LA~YELLOW FEVER (YF-VAX)~2|FLUN3~MEDIMMUNE VACCINES, INC.~500430P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB061AA~2~IM~LA~HEP A + HEP B (TWINRIX)~3|IPV~SANOFI PASTEUR~Y1051~1~SC~RA~POLIO VIRUS, INACT. (IPOL)~3|TDAP~SANOFI PASTEUR~C2457AA~1~IM~RA~TDAP (ADACEL)~3|YF~SANOFI PASTEUR~VEG01A~1~SC~LA~YELLOW FEVER (YF-VAX)~3|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~4|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~HEP A + HEP B (TWINRIX)~4|IPV~SANOFI PASTEUR~~UNK~UN~UN~POLIO VIRUS, INACT. (IPOL)~4|TDAP~SANOFI PASTEUR~~UNK~UN~UN~TDAP (ADACEL)~4|YF~SANOFI PASTEUR~~UNK~UN~UN~YELLOW FEVER (YF-VAX)~4|FLUN3~MEDIMMUNE VACCINES, INC.~500430P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~5|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB061AA~2~IM~LA~HEP A + HEP B (TWINRIX)~5|IPV~SANOFI PASTEUR~Y1051~1~SC~RA~POLIO VIRUS, INACT. (IPOL)~5|TDAP~SANOFI PASTEUR~C2457AA~1~IM~RA~TDAP (ADACEL)~5|YF~SANOFI PASTEUR~VEG01A~1~SC~LA~YELLOW FEVER (YF-VAX)~5	USA	Hospitalisation	Influenza
0316618	06/19/2008	MI	1.3	1	.3	F	06/06/2008	Both legs became reddened and blotchy from ankles to hips, not raised. No temp, swelling or difficulty breathing. Advised to pediatrician.									U	06/02/2008	06/06/2008	4	Not known	PUB	PUB	None	None	None			1						1	Erythema; Injection site erythema; Rash macular	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B054AA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2526AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB213AA~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1943U~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C49918~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0175X~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0316632	06/19/2008	WA	1.0	1	.0	M	06/12/2008	T2 and T3 dermatome involvement. Onset rash 4/19/08. (L) lateral back w/ 20 clustered red papules. (L) post arm w/ 20 clustered red papules. Resolving at 5/14/08 visit.									Y	10/03/2007	04/19/2008	199	None	PVT	PUB	None	None	None			1						1	Erythema; Rash; Rash papular; Herpes zoster; Rash; Rash papular; Skin lesion	FLU3~SANOFI PASTEUR~UT2459MA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB181AA~1~IM~LA~HEP A (HAVRIX)~1|FLU3~SANOFI PASTEUR~UT247CA~1~IJ~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB181AA~1~IJ~LA~HEP A (HAVRIX)~2|MMRV~MERCK & CO. INC.~0911U~1~SC~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~2	USA		Influenza
0317503	06/19/2008	TX	4.0	4		F	05/30/2008	Information has been received from a nurse practitioner concerning a patient who on 17-DEC-2007 was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Concomitant therapy given that same day included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process). The nurse reported the incident was due to human error, there was no product confusion. The patient did not experience any known symptoms. There was no product quality complaint. Additional information is not expected. Further information has been received from the nurse practitioner regarding this four year old female who was vaccinated on 17-DEC-2007 with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 654893/1029F) SQ in the right quad (second dose) and secondary suspect therapy included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (Lot # 656894/0917U) first dose in the right quad. Additional concomitant vaccines included Hepatitis A (GSK) lot# AHAVB182AA IM right quad, DTAP (GSK) lot # ac14B051AA, IM left quad, IPV (SANOFI) Lot # A0169 SQ left quad and FLU vaccine (SANOFI) lot # U2513AA, IM left quad. It was reported that the patient was not seen within 48 hours of vaccination. On 21-DEC-2007 the patients father stated there was no adverse event, only mild tenderness to both legs with mild fatigue. The patients mother stated on 15-JAN-2008 that there was no adverse side effects except for mild pain at the site for two or three days.									U	12/17/2007	12/17/2007	0	Unknown	PVT	PVT			Unknown		WAES0712USA07910	1						1	Fatigue; Incorrect dose administered; Injection site pain; Tenderness	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B051AA~UNK~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2513AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB182AA~UNK~IM~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1029F~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|MMRV~MERCK & CO. INC.~0917U~1~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0317853	06/19/2008	CA	82.0	82		F	06/04/2008	This case was reported by a pharmacist and described the occurrence of injection site pain in a 82-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On 19 February 2008 the subject received unspecified dose of Fluarix (.5 mL, left arm). On 19 February 2008, less than one day after vaccination with Fluarix, the subject experienced injection site pain and bruising at the injection site. At the time of reporting the events were unresolved. The pharmacist considered the events were probably related to vaccination with fluarix.									N	02/19/2008	02/19/2008	0	Unknown	OTH	PVT		Unknown	It was unknown if the subject had received other influenza injections.		A0715584A	1						1	Injection site bruising; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ASL296EA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0317854	06/19/2008					F	06/04/2008	This case was reported by a consumer and described the occurrence of influenza in an adult female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Fluarix (unknown). At an unspecified time after vaccination with Fluarix, in February 2008, the subject experienced influenza and vaccination failure. At an unspecified time after vaccination with Fluarix and on a unspecified date, the subject experienced cough. This case was assessed as medically serious by GSK. The subject was treated with oseltamivir phosphate (TAMIFLU). At the time of reporting the event of influenza was improved, but the subject still had a cough.									N		02/01/2008		Unknown	OTH	OTH		Unknown			A0716858A	1						1	Cough; Influenza; Vaccination failure	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0317855	06/19/2008	CT				U	06/04/2008	This case was reported by a physician and described the occurrence of generalized malaise in an unspecified number of adult subject of unspecified gender who was vaccinated with influenza virus vaccine (FLUARIX, GlaxoSmithKline) for prophylaxis. It was reported that an unspecified number of subjects experienced malaise following previous vaccinations. On an unspecified date the subject received 1st dose of FLUARIX (1 ml, unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced generalized malaise. At the time of reporting the event was resolved. The physician considered the event was probably related to vaccination with FLUARIX. Per the source document, the physician noted that he has noticed malaise in approximately one out of three adult subjects. He was making a broad observation and specific details regarding the number of subjects, time of administration or other details were not provided. The physician noted that the subjects then refuse to obtain subsequent FLUARIX vaccinations in later years due to the malaise. It was reported that an unspecified number of subjects experienced malaise following previous influenza injections and following previous vaccinations.									Y				Unknown	PVT	PVT		Unknown			A0718172A	1						1	Malaise; Vaccine positive rechallenge	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0316750	06/22/2008	MI	0.7	0	.7	M	06/22/2008	Landen was completly normal child until after his 6 month shots he quit putting on weight as fast as he was prior to them. He learn to walk and was talking but was not putting on the wieght I felt he should have. At 8 months he recieved a Influenza shot.  After that shot later he came down with a terrible fever which persisted for three days.  He then came down with exczema which he never had before, he became very aggressive, his sleep patterns got very unorganized he wouldn't sleep only a half and hour during the day and was very crabbie and unhappy child.  He then had croup and recieved a steroid then within a few weeks landen started falling down on his butt and acted week.  he was admitted to the hospital because he was holding his neck back and his eyes looked glazed over and cloudy. An MRI showed Demylination of the brain. We were told our son had a Leukodystrophy of some sorts and probably would not live 6 months.  Those test came back negative, a muscle biopsy was done and a show of mitochondrial disorder was there but we were told it was secondary to something but we didn't know what.  The neurologist put landen on a steroid per our asking to see if he would improve his ability to walk, talk, eat etc. It worked so we are unsure if he suffered from encephalitis, as there was one case of it that looked similar to landens MRI.  The steroids helped and landen started eating better and has started getting much better. Landen had a hair test and blood test done on toxins and had both mercury and aluminum in high amounts in his body which have been detoxifying from his body. I have read about MMR reactions and a couple of stories match landens to a tee, maybe he recieved this accidentally. But one thing is for sure what ever shot he recieved on December 15th, is what spiraled my son into this disability. He is now been diagnosed on the Autism Spectrum for speech problems and motor function problems. He is unable to crawl or walk at this time.  9/5/08 Reviewed new PCP medical records which included several hospital & consult records as well as additional previous PCP medical records. FINAL DX: probable mitochondrial cytopathy characterized by leukodystrophy. Records reveal initial hospitalization 3/26-3/31/2007 for Ataxia.  Ophtho, ID & neurology consults done.  Had 7-10 days of progressive clumsiness & difficulty walking.  D/C to home w/PT/OT & referral to early intervention.  Readmitted to second hospital next day for dehydration & weakness. NGT inserted.  Continued to lose developmental milestones.  Seen out of state at neuro & bone marrow transplant center, no diagnosis provided.  5/07 2nd opnions peds neuro consult.  Given a trial of steroids & improved.  Second hospitalization 5/07 for respiratory distress & acute laryngeal tracheobronchitis.  GI & Genetic clinic consults & swallow study done 7/07.  6/24/08 Reviewed PCP vax records & medical records for 7/5/2006-7/13/2007. FINAL DX: Records reveal patient w/eczema of face on day of vaccination otherwise w/normal G&D.  RTC 1/30/07 w/rash all over body, dx w/eczema.  RTC 2/21 w/croup, 2/23 w/increased croup s/s.  RTC 3/23 w/cold s/s x 3 wks, pulling at ears, loses balance & not acting himself; dx w/sinusitis.  RTC 3/26 w/worsened ataxia & developmental regression, irritable esp w/neck movement, tired, poor eye contact.  Admitted to hospital at that time, MRI c/w leukodystrophy & encephalopathy.  Neuro consult done.  Tx w/steroids & had some improvement in neuro s/s.  Developed URI & conjunctivitis.  Skin & muscle biopsies done.  Multiple bouts of diarrhea & constipation.  Referred to GI.   Developed croup & resp distress 5/07 & hospitalized again.    7/4/08 Reviewed surgeons medical records of skin & muscle biopsy done 6/5/2007 FINAL DX: leukodystrophy Records reveal patient experienced acute onset of frequent falls w/weakness, right greater than left.  Txw/steroids & had improvement.  7/8/08 Reviewed hospital ER records of 7/20/07. FINAL DX: fever, likely viral syndrome; developmental arrest & regression. Records reveal patient experienced progressive deterioration & loss of function w/o clear etiology.  Improved w/high dose steroids temporarily.  7/8/08 Also received referral from neurology clinic to cardiology clinic for echocardiogram 5/30/08 to r/o cardiomyopathy.			Y	Y	Y	5		Y	N	12/15/2006	12/16/2006	1	Hair and Blood samples, MRI, Blood work, Muscle Biopsy, N.A.E.T Muscle Testing,  LABS: Brain MRI 3/07 progressively abnormal white matter c/w metabolic disorder & cytotoxic edema. C-spine MRI WNL. CXR showed right-sided aortic arch.   CSF tests WNL incl c/s neg.  Serum lactic acid 3.2(H).  Swallow study abnormal showing oropharyngeal dysphagia.  Throat c/s 7/07 (+) Klebsiella pneumoniae.  Genetic tests 7/07 WNL.  EMG 4/07 WNL.  Alanine 480(H).  Renal US report of 5/30/08 was WNL. CXR WNL.  MRI revealed leukodystrophy.  Skin & muscle biopsies neg for mitochondrial abnormalities.  US for pyloric stenosis neg.	UNK	UNK	Steroids, Amoxicillian	None	None PMH: several bouts of URI & sinusitis.  Croup 2/07.  Sinusitis 3/07.  Absent uvula. Lacrimal obstruction, rash, excessive spitting up, sleep disturbance. Birth hx: NSVD, apgars 8/9 @1/5 min.	Fever~Influenza (Seasonal) (no brand name)~0~0.70~Patient		1						1	Abasia; Aggression; Asthenia; Autism spectrum disorder; Blood mercury abnormal; Croup infectious; Demyelination; Eczema; Eye disorder; Fall; Hair metal test; Hair metal test abnormal; Insomnia; Irritability; Mitochondrial cytopathy; Mood altered; Motor dysfunction; Musculoskeletal discomfort; Pyrexia; Speech disorder; Weight gain poor	FLU3~SANOFI PASTEUR~UT 2200PA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0316860	06/23/2008	TN	53.0	53		F	03/28/2008	This case was received from a consumer on 27 March 2008.  A 53-year-old female patient, with a history of restless legs syndrome, received a right deltoid intramuscular injection of FLUZONE (lot number U2489AA) on 08 February 2008.  On 13 February 2008, she complained of flu-like symptoms including fever, chills, and severe headache.  The patient recovered on an unknown date.  The reporter for this case also reported an event for the patient's sister following FLUZONE administration.  That report, which included the serious events of optic nerve edema, blurred vision, vision disturbance, dilated pupils, and headache, is captured in case number 2008-00893.									Y	02/08/2008	02/13/2008	5		UNK	UNK			Restless leg syndrome		200800894	1						1	Chills; Familial risk factor; Headache; Influenza like illness; Pyrexia	FLU3~SANOFI PASTEUR~U2489A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0316949	06/23/2008	MI	47.0	47		F	06/23/2008	11/18/07 Neck and right shoulder pain, difficulty lifting right arm.  Determined to be acute right brachial neuritis.  Treated with physical therapy.  Is still not back to pre vaccine status, is begining to get some use back.									N	10/19/2007	11/18/2007	30	BRACHIAL PLEXUS MRI WITH CONTRAST: Findings:  There may be minimal increased T2 signal in the deltoid muscle.  No soft tissue mass lesions are identified in the supraclavicular fossa or along the course of the brachial plexus bilaterally.  No abnormal contrast enhancement is seen.	UNK	UNK	Multiviamin, Pseudovent, Toprol XL, Relafen, Flexeril, Hydrochlorothiazide	None. Previously had brachial neuritis in 1987, not known to be related to vaccine.  Sister and son also had episodes, not known to be related to vaccines.	Mono-1978 Bladder carcinoma-transitional cell. MVA with neck injury-1988 Asthma, Raynaud's Syndrome, drug allergies-Procardia, PCN, sulfa, talwin,erythromycin.  food allergies-strawberries, mushrooms.  Bee sting allergy			1						1	Condition aggravated; Injected limb mobility decreased; Musculoskeletal pain; Neck pain; Nuclear magnetic resonance imaging normal; Radiculitis brachial	FLUN3~MEDIMMUNE VACCINES, INC.~500486P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0316959	06/23/2008	MN	23.0	23		F	06/23/2008	Nausea for about a week,then felt good for about 3 week, then had burning sensation back of head and felt light headed and that lasted for about a week, then once again disappeared and then I got sick to my stomach, bad stomach pains that lasted about 6 weeks, then that went away then I had bad headaches with sharp shooting pains, burning sensations at the back and the front of the head, and had teethache even took trips to the dentist to find out everything was ok the duration of the headaches lasted about 3 1/2 months.  Then had leg/muscle pains for about 3 weeks, joint pain, andchest pain, sensation of not able to get enough air that take place on in off over the past 8 months, and tireness.  7/15/08 Reviewed vax & PCP medical records. Received HPV #1, lot# 0525U, RA on 8/28/07.  Records indicate patient tolerated HPV #1 well.    9/9/08 Reviewed additional PCP medical records. FINAL DX: none provided Records reveal patient experienced general good health on 8/28/07 but with bilateral ear discomfort & wisdom teeth coming in.  RTC 7/15/08 & seen by Rheum c/o feeling unwell since 10/2007 w/multiple complaints of lightheadedness, nausea, HA, abdominal pain, sensitive teeth, burning ears, arthralgias, paresthesias, chest discomfort, difficulty breathing, feelings of impending doom, .   Had been seen by GI & dx w/IBS.  Seen by Neuro & exam was WNL.  RTC 7/21/08 c/o nausea, tooth pain & increased heart rate, no diagnosis provided.  RTC 8/12/08 for intermittent dizziness x several months, achy & joint pain				Y					N	11/16/2007	11/18/2007	2	Lots of lab work and ct scans to find out nothing.I did test slighty positive on lupus and then was tested again and more in depth and then that was negative.  LABS: ANA (+) w/speckled pattern.  CBC & UA WNL.  ESR 8  TSH 1.34.  CXR, abdominal US & echocardiogram all WNL.  EKG WNL. Head MRI WNL.  PAP smear neg.	UNK	UNK	None	None	None  PMH: never had sexual intercourse, sibling w/polymyositis,  family hx of breast cancer, OA, HTN & diabetes. Occasional right side pelvic cramping near right ovary.			1						1	Abdominal pain upper; Arthralgia; Burning sensation; Chest pain; Diagnostic procedure; Dizziness; Fatigue; Headache; Laboratory test; Myalgia; Nausea; Pain; Pain in extremity; Stomach discomfort; Toothache	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU310BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|HPV4~MERCK & CO. INC.~1263U~2~IM~LA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0317134	06/24/2008	AL	62.0	62		F		Patient got the flu, her ears got stopped up, could not hear nothing but a buzzing.  Patient went to the doctor to see why and said she had a cold.  Medicine did not help.  Kept on going to the doctor's getting medicine for ears.  Patient went about 6 or 8 times then went to (ENT) about two times.  Second time went in the hospital. 7/28/08-records received for DOS 5/9/08-C/O ear infection since last fall, lost some hearing, on multiple antibiotics, chronic cough. Tubes in ears. No reaction from previous flu vaccine.								Y	N	10/01/2007	10/01/2007	0		PVT	UNK		None	None 7/28/08-records received-PMH:hypothyroidism, multinodular goiter.			1						1	Influenza; Nasopharyngitis; Tinnitus	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0317142	06/24/2008	AL	71.0	71		F	06/18/2008	-red scaly rash on hand reported to doctor 10 March 2006. -soreness in arm, shoulder in hand still present to this day. -trouble lifting things and doing every day activities. - generalized arthropathy diagnosed by doctor				Y						11/17/2005	11/24/2005	7		PVT	UNK		None				1						1	Activities of daily living impaired; Arthropathy; Exfoliative rash; Musculoskeletal pain; Pain in extremity; Rash erythematous	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~61129~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1038P~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0317163	06/24/2008	WI	34.0	34		F	05/14/2008	Patient received flu shot to left deltoid, IM on 10-31-07.  Patient noticed small 1/16 lump in injection area.  This lump is not red or painful but has persisted.									Y	10/31/2007	11/02/2007	2		OTH	PVT	None	No	None			1						1	Injection site mass	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA303AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0317215	06/24/2008	VA	1.25	1	.2	F	06/19/2008	Had VARIVAX shot 11-21-07 however contracted chickenpox pustular lesions on erythematous bases post neck. (L) check, (R) hip and pruritis (has had sev. d). Obviously not shot Rx									U	11/21/2007	06/17/2008	209	Physical examination	PVT	PVT		None	At birth borderline LGA. Mom had varicella infection 35 weeks gestation			1						1	Erythema; Pruritus; Varicella	FLU3~SANOFI PASTEUR~UT2460AA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB176AA~1~UN~UN~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0426U~1~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~11070~1~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0317240	06/24/2008	OH	57.0	57		M	06/24/2008	loss of appetite, no energy				Y					U	06/11/2008	06/14/2008	3		UNK	UNK		none	none			1						1	Anorexia; Asthenia	FLU3~SANOFI PASTEUR~U2527AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1837U~1~IM~LA~HEP B (RECOMBIVAX HB)~1|HEPA~MERCK & CO. INC.~AHAVB224AA~1~IM~RA~HEP A (VAQTA)~1|TYP~SANOFI PASTEUR~A022~1~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0317267	06/24/2008	MA	52.0	52		M	05/05/2008	Mid January, pt developed curling of the three middle fingers associated with the ulnar nerve (ring, small and middle). The fingers can't be opened straight on exam must be held open. MRIs 3/28/08. Neurologist told pt that based on the blood work, it was a viral infection of the ulnar nerve related to the flu vaccine.									N	11/13/2007	01/15/2008	63	MRI, blood work	PUB	UNK		Diabetes, Hypertension; Increased triglycerides	NKA		MA0809	1						1	Blood test; Movement disorder; Nerve injury; Nuclear magnetic resonance imaging; Viral infection	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA050AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0305133	06/25/2008	NY	44.0	44		M	06/23/2008	Temporary VAERS E-report number: E-20977. Initial report received on 20 February 2008 from a nurse who provided us with a copy of the electronic VAERS report that she submitted to Centers For Disease Control and Prevention (CDC). A 44-year-old male patient with no concurrent illnesses or pre-existing medical conditions, had received an intramuscular left deltoid dose of ADACEL (lot number C2769AA; and an intramuscular right arm dose of FLUVIRIN (manufacturer Novartis, lot number 08682) on 29 November 2007. Approximately one week post-vaccination (around 05 December 2007), the patient reported he developed pain and impaired range of motion/function to his left arm. At that time, the patient reported pain radiating from his left shoulder to his elbow, and his arm was weak. He stated that he had difficulty abducting his left arm; however, he was able to move his left shoulder with full range of movement. The patient stated he was unable to lift items with his left arm for a period of a few weeks. He also reported these symptoms slowly improved over time, and at the time he had reported this to the Nurse on 14 February 2007, he was able to demonstrate active range of motion to the left shoulder and arm without evidence of limitation, and that he was currently only experiencing pain from my shoulder to my elbow when I cough. The patient did not seek medical attention. Treatments received and diagnostic tests performed were not provided. The patient was referred to another physician for evaluation. The contact information of that physician was not provided. At the time of this report, the patient had not recovered. Follow-up information received on 19 June 2008 from the original reporter who is a nurse. The patient did not participate in any sports prior to, or after vaccination on 29 November 2007. Per the reporter, the patient did not seek medical care for his symptoms prior to reporting the events to them. By the time the patient had reported the events to them, he had almost completely recovered. After the reporter discussed the case with the medical director, who is a physician, the patient's symptoms appeared to be consistent with descriptions of brachial neuritis in the literature, and at that time the logical conclusion was that this was in fact brachial neuritis that had nearly resolved. As of May 2008 the patient had fully recovered from the temporary pain and impaired range of motion/function of his left arm. Per this new information, this case was upgraded to serious.				Y					Y	11/29/2007	12/06/2007	7		OTH	PUB			The patient had no illnesses, or pre-existing medical conditions at the time of vaccinations on 29 November 2007. From new information received on 19 June 2008, the patient did not participate in any sports prior to, or after vaccination on 29 November 2007.		200800532	1						2	Injected limb mobility decreased; Muscular weakness; Musculoskeletal pain; Pain in extremity; Injected limb mobility decreased; Joint range of motion decreased; Muscular weakness; Pain in extremity; Radiculitis brachial	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~08682~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C2769AA~UNK~IM~LA~TDAP (ADACEL)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~08682~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|TDAP~SANOFI PASTEUR~C2769A~UNK~IM~LA~TDAP (ADACEL)~2	USA	Emergency room visit	Influenza
0317375	06/25/2008	IA	49.0	49		F	06/19/2008	Pain and stiffness in shoulder and deltoid muscle at injection site.									N	10/28/2007	10/28/2007	0	None	PUB	OTH	Unknown	None	Unknown			1						1	Injection site pain; Musculoskeletal stiffness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA315AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0317640	06/26/2008	CT	0.5	0	.5	M	06/26/2008	Loose stool day before - severe abdominal pain.  8/12/08 Received copy of letter from surgeon to PCP dated 7/14/08.  Patient had been seen in office on 7/9 s/p air enema reduction for IS approx 2 wks prior.  Was doing well & was d/c from further f/u./ss  8/15/08 Reviewed hospital medical records of 6/24-6/25/2008 FINAL DX: Intussusception Records reveal patient experienced intermittent abdominal pain x 1 day with one loose stool.  Temperature 100, pulse 120.  Peds surg consulted.  Admitted overnight for observation s/p enema reduction of IS.  Progressed well & d/c to home w/peds surg & PCP f/u.					Y	1			Y	10/02/2007	06/24/2008	266	LABS: US of abdomen (+) IS.  Air enema reduced.	PVT	PUB						1						1	Abdominal pain; Diarrhoea	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B132BA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2490AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~B473008~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0553U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0317908	06/30/2008	PA	1.1	1	.1	F	06/27/2008	Varicella vaccine breakthrough.  Seen 6-24-08 with over 100 lesions, no fever, diagnosed with varicella.									U	10/25/2004	06/23/2008	1337		PVT	PVT	No	No	No			1						1	Varicella post vaccine	FLU3~SANOFI PASTEUR~U1476AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~A83578K~4~IM~LA~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0648P~1~IM~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0302844	07/01/2008	TN	36.0	36		M	06/30/2008	SM reports that he received the live, intranasal flumist on 5 NOV 07 at camp in foreign country. Approximately 1 week later, developed arthralgias (shoulders, hips and knees), myalgias and fatigue. He self medicated MOTRIN 800 mg and felt better in 2-3 days. On 15-Nov (10 days post-vaccine) he C/O headache (dull, frontal without sinus pain), fevers, chills and night sweats. He sought medical care in the clinic & was told to discontinue MOTRIN, start TYLENOL PRN and to increase his fluid intake. Two weeks post vaccine he developed nasal congestion, post nasal drip, tickling in his throat, and a cough described as hacking all night long and during the day. The cough was associated with some SOB which prevented him from exercising. He took NYQUIL and ROBITUSSIN without improvement. On 4 Dec 2007 (1 month post vaccine) he noticed some dark spots on his lower lips & legs. This following day he had a nose bleed, bleeding from the lesion on lip and blood in the mucous from his nose and phlegm from coughing. He was seen in the clinic on 05 DEC 07 and diagnosed with pneumonia. A CBC showed thrombocytopenia with a platelet count of 0. He was transferred to medical center were he received a 6 pack platelet infusion and IVIG 110 grams x 1 dose. His platelets gradually increased. On 17 Dec 07 he was transferred to medical center on PREDNISONE 60 mg daily. He is currently on PREDNISONE 60 mg daily with a platelet count in the 260 range. His platelets are checked every 2 weeks and he is seen by Oncology once a month. Symptoms: Joint Pain, multiple joints, Muscle Pain, Fatigue, Malaise <60 Days, Flu-like symptoms < 96 hours.					Y	10				11/05/2007	11/12/2007	7	13 Dec 07-CBC WBC 10.8 > (3.5-10.5); PLT <149 (151-356); Lymph % < 16.9 (18-51); Neutrophils > 7.39% (35-73); Neutrophils > 8.0 (1.6-6.5); Monocytes 1.0> (0.2-0.8); BMP glu 120> (74-106); K 3.5 < (3.6-5.10); CL 99< (101-111); Coags, LFT WNL all other tests WNL; 27 Jan 08 PLT 177 (162-427) WNL: 19 Jan 08 PLT 165 (162-427) WNL; 02 Jan 08 PLT < 146 (162-427); 19 Dec 07 WBC > 111 (3.5-10.5); PLT 252 (162-427); 13 Dec 07 CBC WBC 10.8 > (3.5-10.5); PLT < 149 (151-356); Lymph % < 16.9 (18-51); Neutrophils > 7.39% (35-73); Neutrophils > 8.0 (1.6-6.5); Monocytes 1.0 > (0.2-0.8); BMP glu 120> (74-106); K 3.5 < (3.6-5.1); CL 99< (101-111); all other tests WNL	UNK	UNK	BISOPROLOL 10 mg daily	None	HTN			1						2	Chills; Dermatitis bullous; Full blood count normal; Idiopathic thrombocytopenic purpura; Laboratory test normal; Liver function test normal; Malaise; Mononucleosis heterophile test negative; Productive cough; Pyrexia; Skin lesion; Activities of daily living impaired; Arthralgia; Blood chloride decreased; Blood glucose increased; Blood potassium decreased; Blood product transfusion; Chills; Coagulation test normal; Cough; Dyspnoea; Epistaxis; Fatigue; Full blood count abnormal; Haemoptysis; Headache; Increased upper airway secretion; Influenza like illness; Lip haemorrhage; Liver function test normal; Lymphocyte percentage decreased; Malaise; Monocyte count increased; Myalgia; Nasal congestion; Neutrophil count increased; Neutrophil percentage increased; Night sweats; Platelet count decreased; Platelet transfusion; Pneumonia; Pyrexia; Rhinorrhoea; Skin discolouration; Throat irritation; Thrombocytopenia; White blood cell count increased	FLUN3~MEDIMMUNE VACCINES, INC.~500491P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500491P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Hospitalisation	Influenza
0318125	07/02/2008	AZ	33.0	33		M	07/02/2008	Chest pain 10-14 days post vaccination assoc with nausea, dizziness, SOB, and radiation.  Evaluation at civilian hospital and told he had myocarditis.  Continues to have discomfort with exertion. Has not pushed himself.  Is taking ibuprofen daily.  Pt stated VAERS had been filed.  No report available for verification.  Symptoms: Chest Pain, sub-sternal.  8/12/08 Reviewed hospital records of 1/15-1/16/2007. FINAL DX: non-acute MI secondary to myocarditis; myopericarditis; dyslipidemia. Records reveal patient experienced chest discomfort during PT 1 day prior to admission.  The chest pain was sharp, shooting into his left cheek & lasted approx 8 hrs.  Pain resolved w/NSAID but returned next day, increasing w/deep breaths & radiating to jaw assoc w/nausea, dizziness & SOB, lasting approx 30 min.  Went to ER where abnormal EKG & (+) cardiac biomarkers were found & transferred to higher level of care.   Remained stable & d/c to outpatient cardiac f/u.					Y	1			N	01/04/2007	01/14/2007	10	15 Jan: Trop I 24.38, CK 565, MB 164.2.  15 Jan 07 - ST elev in II, III AVF, V4-6, Slight dep V1-2.  23 Feb 07 - proximal lateral and distal anterior L ventricular myopericarditis.  17 Dec 07 - Persistent focus of enhancement in the lat wall with unchanged size of enhancement characteristics.  No evidence of wall motion abnormalities.  LABS: EKG showed diffuse ST elevation.  Echocardiogram revealed hypokinesis of LV lateral wall & EF of 55%.  Cardiac cath revealed 35% proximal LAD stenosis.  Troponin peak 24.38(H), CK peak 565(H).  CRP 34(H).  CBC w/monos 11%(H).  Cholesterol 173, triglycerides 85, HDL 31(L), LDL 125. SGOT 61(H), SGPT 41(H).  CXR WNL.	MIL	MIL	none	viral illness	01/20/2008 Myocarditis, acute (In remission), 01/20/2007 Acute Pericarditis (In remission)			1						1	Blood creatine phosphokinase MB; Blood creatine phosphokinase increased; Chest pain; Dizziness; Dyspnoea; Dyspnoea exertional; Echocardiogram abnormal; Electrocardiogram ST segment elevation; Myocarditis; Nausea; Troponin I increased	FLU3~SANOFI PASTEUR~500442P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB257BA~UNK~IM~UN~HEP B (ENGERIX-B)~1|SMALL~PFIZER\WYETH~4020072~UNK~ID~UN~SMALLPOX (DRYVAX)~1	USA	Hospitalisation	Influenza
0318156	07/02/2008	CA	65.0	65		F	07/02/2008	Patient complains of pain at injection site since injection.  Now pain radiates down all the way to elbow.  She can not lift her arm still without pain.									N	10/18/2007	10/18/2007	0		UNK	UNK		none	none			1						1	Injected limb mobility decreased; Injection site pain	FLU3~SANOFI PASTEUR~02489aa~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0318157	07/02/2008	PA	14.0	14		F	07/02/2008	Adult dose of Influenza Vaccination administered, onset of nausea, abdominal pain, headaches, myalgia started the following day. Abdominal sx  continued, patient lost 15 lbs in six weeks and was hospitalized. Gastrointestinal symptoms later diagnosed as gastrointestinal dysmotility secondary to a clinical diagnosis of mitochondrial disease (diagnosed in 2002).  The initiation of the influenza vaccination was the trigger for the start of the mitochondrial symptoms. 8/13/08-records received-office visit 10/5/92-presented with C/O persistent sore throat present for approximately 1 week. Developed white spots on tonsils and felt unwell, always tired. Retin-A for acne. Assessment viral pharyngitis, acne, 10/7/02 continues with C/O sore throat. 10/19/02 seen for persistent symptoms and after flu shot C/O fatigue, chronic headaches, anorexia and constant nausea with  7lb weight loss. Low grade temps. Assessment probably viral syndrome. 11/2/92 C/O continued nausea and additional weight loss. 11/9/02-heart murmur detected, systolic murmur. 7/7/94-receiving TPN via jejunostomy feedings for intestinal pseudo-obstruction. 3/30/98-orthostatic intolerance may be contributing to symptoms of abdominal pain particularly when it is provoked by exercise.  4/3/01-C/O increased weakness with ambulation and stumbling gait. Assessment extreme muscle fatigue. 4/25/03-symptoms suggestive of an underlying mitochondrial disease. 6/30/03-chronic pseudo-obstruction associated with abdominal pain, diarrhea presumably from bacterial overgrowth, chronic/recurrent pancreatitis, autonomic dysfunction, muscle fatigue with reduced endurance, muscle cramping post exercise, chronic thrombocytopenia, retinal pigmentation,  pancreatitis, GERD, SVT..				Y	Y	21		Y	N	10/05/1992	10/06/1992	1	8/13/08-records received-Electrogastrogram showed significant tachygastria with loss of 3cpm from stomach characteristic of insulin sensitivity. 11/19/02 GI endoscopy, chest x-ray and EKG normal diagnosed with eating disorder. 5/26/94-abnormal gastrointestinal manometry characterized by lack of antral activity.	UNK	UNK		sore throat/mild head cold 8/13/08-records received-office visit 10/5/92-presented with C/O persistent sore throat present for approximately 1 week.	asthma 8/13/08-records received- PMH-asthma and allergy history,			1						1	Abdominal pain; Gastrointestinal disorder; Headache; Mitochondrial myopathy; Myalgia; Nausea; Weight decreased	FLUX~UNKNOWN MANUFACTURER~~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0318171	07/02/2008	TX	42.0	42		F	06/27/2008	Received IM flu vac 12/3/07.  Approx 20-30 later developed wheeze sensation, difficulty breathing w/SOB while driving.  Took SL BENADRYL 25 mg w/some relief and repeated 15-20 min later while driving home.  1.5 hr later home somewhat better.  C/O wheeze feeling and not feeling right as if allergies triggered (ragweed) achy feeling and problems breathing.  She denied eating, drinking, ingestion of any type, no new perfumes, odors/smells, no new clothing, no stings/insect bites, windows were up driving as cold (December in Texas).  No medical care obtained.  Did contact command 12/4 and PCP 12/5/07 who recommended exemption to flu vaccine.  Symptoms: Dyspnea (shortness of breath), Wheezing.				Y					U	10/30/2001	12/03/2007	2225	pending	UNK	UNK	none	none	12/03/2007 Wheezing (Resolved)			1						1	Dyspnoea; Feeling abnormal; Hypersensitivity; Pain; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~SC~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|OPV~UNKNOWN MANUFACTURER~~UNK~PO~MO~POLIO VIRUS, ORAL (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0318173	07/02/2008	PR	47.0	47		M	06/27/2008	SM with hx of HTN treated with lisinopril, COREG received SMPX 1/17/2006.  In 6/2008 he was diagnosed with vaccine mediated cardiomyopathy vs hypertensive cardiomyopathy.  CG requesting eval for possible causality.  Symptoms: Hypertension, high (140-159/90-99).									N	01/17/2006	06/25/2008	890	not available	MIL	MIL	lisinopril, COREG	hypertension	06/26/2008 Cardiomyopathy, secondary NOS (Active)			1						1	Cardiomyopathy; Hypertension	FLU3~SANOFI PASTEUR~U1869AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~PFIZER\WYETH~4020072~UNK~ID~UN~SMALLPOX (DRYVAX)~1	USA		Influenza
0318188	07/03/2008	SC	3.0	3		M	07/01/2008	This report was received on 27 December 2007 from a health professional.  Upon receipt of follow-up information on 26 June 2008, it was determined that the event meets seriousness criteria.  SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  A three-year-old male patient, with a history of peanut allergy, received an intramuscular left thigh injection of FLUZONE (lot number U2523AA) on 19 December 2007.  Approximately four hours after vaccination, he developed an eye tic.  Per the reporter, the symptom began to resolve after two days.  No treatment was given, and no testing was performed.  The patient was not taking any concomitant medications.  Follow-up information was received from the health professional on 26 June 2008.  The patient received no other vaccines on 19 December 2007, and was not ill at the time of vaccination.  The reporter described the event as intermittent tic disorder, apparently vaccine related.  No additional information was provided.				Y					N	12/19/2007	12/19/2007	0		PVT	PVT			Peanut allergy.  The patient was not ill at the time of vaccination, and received no other vaccines on 19 December 2007.		200704409	1						1	Tic	FLU3~SANOFI PASTEUR~U2523AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0318256	07/07/2008	PA	38.0	38		F	07/02/2008	Initial report received on 02 November 2007 from a health care professional.  A 38-year-old female patient, who was pregnant at the time of vaccination, had received a first dose, left deltoid, intramuscular injection of FLUZONE SV 2007-2008, lot number U2526AA, on 30 October 2007.  Two days post-vaccination, the patient experienced a sore throat, and it was uncomfortable to swallow.  The event did not require medical examination.  The patient experienced no fever or chills and slept well.  Last menstrual period and estimated date of delivery were not provided.  Other medications included prenatal vitamins.  The patient recovered from the event.  Follow-up information received on 26 November 2007 from the patient.  The patient's primary care provider, OBGYN, and Maternal Fetal Medicine Center contact information was provided.  The patient has no known allergies but could possibly have a history of environmental allergies.  The patient experienced symptoms of coughing and headache two days post-vaccination (02/Nov/2007), in addition to the previously reported adverse events of sore throat, and it was uncomfortable to swallow.  The date of the patient's last menstrual period was reported as unknown; but the expected date of delivery was reported as 13 March 2008.  Prenatal testing so far includes: ultrasound (routine), completed on 08 August 2007 (within normal limits); ultrasound for high risk age, completed on 30 August 2007 (results not reported); and ultrasound for high risk age, completed on 31 October 2007 (results not reported).  The patient is scheduled to see her OBGYN on 03 December 2007, and her next ultrasound is scheduled for 04 January 2007.  The recovery status of the coughing and headache was not reported.  At the time of this report, the recovery status was amended to not recovered.  Follow-up information received on 24 June 2008 from a health care professional.  Per the reporter, the patient's obstetrical history included two previous pregnancies that resulted in one live birth and one spontaneous abortion prior to 20 weeks of gestation.  The patient did not use alcohol, tobacco or recreational drugs during her current pregnancy.  Ultrasound completed on 08 August 2007 confirmed the patient's pregnancy at eight weeks six days gestation.  Another ultrasound completed on 31 October 2007 showed a normal appearing fetus at 20 weeks four days gestation.  An Alpha feto protein test (date not reported) showed an increased level of hcg).  The patient did not see the physician for any complaints regarding her pregnancy following her FLUZONE vaccination on 30 October 2007.  However, the patient did have complication of pregnancy identified as complete placenta previa requiring primary cesarean section on 21 February 2008.  The patient did not experience any complications of labor and/or delivery.  She did not experience any post operation or post partum sequelae.  The patient delivered one, live male child who's Apgar scores were eight at one minute, and nine at five minutes.  The baby weighed six pounds one ounce (3 kilogram), and he had no congenital anomalies.  Due to this new information, the case was upgraded to serious.				Y					N	10/30/2007			Ultrasound (routine): Completed on 08 August 2007, within normal limits.  Ultrasound for high risk age: Completed on 30 August 2007 (results not reported).  Ultrasound for high risk age: Completed on 31 October 2007 (results not reported).	OTH	OTH	Pre-natal vitamins		The patient was pregnant at the time of vaccination.  She had no illness at the time of vaccination.  From new information received on 26 November 2007, the patient denied any past medical history and has no known allergies, but could possibly have a history of environmental allergies.  From new information received on 24 June 2008, the patient's obstetrical history included two previous pregnancies that resulted in one live birth, and one spontaneous abortion prior to 20 weeks gestation.		200703704	1						1	Cough; Drug exposure during pregnancy; Dysphagia; Headache; Pharyngolaryngeal pain; Placenta praevia; Ultrasound scan normal	FLU3~SANOFI PASTEUR~U2526A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0318381	07/07/2008	LA	18.0	18		F	07/07/2008	stomach spasms, which have been diagnosed as abdominal myoclonus.  has led to spasms in back, legs, face.  Is on klonzapen daily, cymbalta.  was on other medications but have since been taken off them.  had to sit out semester of college. 8/14/08-records received for DOS 12/14-12/16/07-DC DX: Gastroenteritis now improved. Developed nausea, vomiting, diarrhea and abdominal crampy pains, presented to ED.  1/25/2010 Follow up: Diagnosed with myclonus. Takes 7-8 medications daily, maybe for life.				Y	Y	2			N	10/20/2007	12/11/2007	52	numerous blood tests, ct scans, mri's, colonoscopy, endoscopy, spinal tap, eeg, ekg, 8/14/08-records received-CBC, complete metabolic profile, anylase, lipase, ultrasound of gallbladder all normal. CT scan of abdomen negative.	UNK	UNK		upper respritory infection	allergic to codeine			1						1	Abdominal pain upper; Activities of daily living impaired; Colonoscopy; Electrocardiogram; Electroencephalogram; Endoscopy; Lumbar puncture; Muscle spasms; Myoclonus; Nuclear magnetic resonance imaging	FLU3~SANOFI PASTEUR~424562A~3~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~12654~2~IM~LA~HPV (GARDASIL)~1|TDAP~SANOFI PASTEUR~C2812AA~3~IM~LA~TDAP (ADACEL)~1	USA	Hospitalisation	Influenza
0318388	07/07/2008	CA	4.0	4		M	07/07/2008	My son had what I believe to be a seizure on the day after he received a flu shot. He fell out of his chair (as if something had scared him) and he started to convulse on the floor for about ten seconds and then stood up, sat down and continued to play while his body was stiff and still jerking a bit.				Y					Y	11/06/2007	11/07/2007	1		PVT	UNK	Singulair 4mg; Zyrtec 5mg; Nasonex 50 mcg	none	Allergies to cow's milk and dust mites			1						1	Convulsion; Dyskinesia; Fall; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U2530AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0318462	07/08/2008	IL	20.0	20		M	06/30/2008	None stated.				Y					Y	06/02/2008	06/02/2008	0	None	MIL	MIL		None	None			1						1	Unevaluable event	FLU3~AVENTIS PASTEUR~U2516AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB11~1~IM~LA~HEP A + HEP B (TWINRIX)~1|MMR~MERCK & CO. INC.~0454X~1~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|MNQ~SANOFI PASTEUR~U2617AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2767AA~1~UN~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0318465	07/08/2008	KS	42.0	42		M	07/01/2008	Arthralgias post AVA #6 with later development of sleep disturbance, chronic fatigue, impaired memory and concentration, and possible post exertional malaise.  Symptoms: Fatigue, Malaise >60 Days, Insomnia, Cognitive deficiency, Joint Pain, multiple joints.				Y					N	01/14/2008				MIL	MIL	none	none	Obstructive sleep apnea.			1						1	Arthralgia; Disturbance in attention; Fatigue; Memory impairment; Sleep disorder	ANTH~MICHIGAN DEPT PUB HLTH~~6~SC~UN~ANTHRAX (NO BRAND NAME)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TYP~UNKNOWN MANUFACTURER~~UNK~IM~UN~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~UNK~SC~UN~VARICELLA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0318648	07/10/2008	DC	20.0	20		M	07/07/2008	Developed sxs ofIDP 4 days after multiple vaccines in training. Sxs effect both feet and both biceps. Had 1st round of IVIG in June 08, 6 months after initial sx development and has had some improvement. Is being medically separated from the military. Wears a breace on rt foot in order to walk. Symptoms: Weakness, Neuopathy.  8/8/08 Reviewed medical records for  12/2007-7/2008. FINAL DX: Idiopathic acute polyneuropathy Records reveal patient experienced weakness, paresthesias of lower extremities w/difficulty walking on 12/22/2007.  PT was not helpful.  Referred to neuro.  Condition progressed to include weakness & paresthesias of upper extremities & impairs activities of daily living.  Tx w/IVIG 6/2008 w/some improvement.										12/18/2007	12/22/2007	4	Elevated CRP/ESR. EMG/NCV abnormal in upper and lower extremities.  LABS: EMG/NCS abnormal.  CT c-spine & head WNL.  X-ray right foot WNL.  CRP 7.59(H).  Genetic testing abnormality.	UNK	UNK	None	None	07/07/2008 Demyelinating polyneuritis, chronic inflammatory (Active)			1						1	Asthenia; C-reactive protein increased; Demyelinating polyneuropathy; Electromyogram abnormal; Nerve conduction studies abnormal; Orthosis user; Red blood cell sedimentation rate increased; Walking disability	FLUN3~MEDIMMUNE VACCINES, INC.~500476P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB103AA~UNK~UN~UN~HEP A + HEP B (TWINRIX)~1|MMR~MERCK & CO. INC.~0868U~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|MNQ~SANOFI PASTEUR~U2409AA~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2842AA~UNK~UN~UN~TDAP (ADACEL)~1	USA		Influenza
0318663	07/10/2008	IL	1.25	1	.3	M	07/09/2008	10 days after the MMR vaccine, pt had a fever between 103-105 for 5 consecutive days.  On day 2, he started having myoclonic jerks that persisted for about 36 hours.  These myoclonic jerks have since occurred every time he has a fever.  He is almost 3 years old.  He is treated with Ativan while febrile.				Y					N	12/05/2006	12/15/2006	10	Myoclonic jerks demonstrated on EEG.  MRI of brain normal.  Genetic testing normal.	PVT	UNK	None	None	None	myoclonic jerks~Measles (Attenuvax)~1~1.00~In Sibling1		1						1	Electroencephalogram abnormal; Laboratory test normal; Myoclonus; Nuclear magnetic resonance imaging brain normal; Pyrexia	DTAP~SANOFI PASTEUR~C2649AA~4~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2175DA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~C987F~1~IM~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1052F~1~IM~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0316632	07/11/2008	WA	1.0	1	.0	M	07/03/2008	Information has been received from a medical assistant concerning a 17 month old male with no pertinent medical history or drug allergies who on 03-OCT-2007 was vaccinated SC with a 0.5 ml dose of PROQUAD (lot# 657270/0911U).  Concomitant vaccinations administered on that same day included a dose of VAQTA (inactive) (manufacturer unknown) and a dose of Influenza virus vaccine (unspecified).  The patient developed shingles consisting of approximately 20 lesions on each area of his left upper arm, left upper back and chest 6 months after vaccination.  The patient was seen by the physician for medical attention.  No labs or diagnostic studies were performed.  The patient was not recovered at the time of this report.  No further information is available.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/3/2008. Follow-up information from a physician indicated that the 18 month old male who on 03-OCT-2007 was vaccinated SC with his first dose of PROQUAD (Merck) (lot# 675270/0911U) in the anterolateral left arm. There was no illness at the time of vaccination. Concomitant vaccinations administration on that same day included the first dose of HAVRIX (lot# AHAVB181AA) in the left deltoid and the first dose of FLUZONE (lot# UT2474CA). On 23-APR-2008 the patient experienced shingles characterized by T2-T3 dermatomal distribution of clustered papules on the left back arm and left upper back immediately adjacent to the arm rash. No labs or diagnostic studies were performed. On 14-MAY-2008 the patient recovered from shingles. Additional follow-up information from a physician in the same office indicated that the 18 month old male with on history of chickenpox or recent exposure to chickenpox or herpes zoster and an onset of rash which began on 19-APR-2008 with approximately 20 clustered red papules on the left lateral back at T2 & T3 and 20 clustered papules on the left lateral back arm. The rash did not occur at the injection site and was not within 42 days after vaccination. The patient did not have a temperature and pain 1 out of 10. No direct fluorescent antibody, PCK specimen collection or photo noted. Additional information has been requested.				Y					Y	10/03/2007	04/19/2008	199	None	PVT	PVT			None		WAES0804USA05079	1						2	Erythema; Rash; Rash papular; Herpes zoster; Rash; Rash papular; Skin lesion	FLU3~SANOFI PASTEUR~UT2459MA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB181AA~1~IM~LA~HEP A (HAVRIX)~1|FLU3~SANOFI PASTEUR~UT247CA~1~IJ~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB181AA~1~IJ~LA~HEP A (HAVRIX)~2|MMRV~MERCK & CO. INC.~0911U~1~SC~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~2	USA	Emergency room visit	Influenza
0318710	07/11/2008	IL	23.0	23		F		The Patient is a 23 year old female.  She reported: Encounter Background Information: pt was discharged from the medical center today.  Pt was in-patient at the medical center bec of possible varicella after the chicken pox vaccination 3-4 wks ago. Pt was told that it could just be a allergic reaction to the varicella shot.  Pt. stayed in the hospital for 5 days.  The skin lesions are all gone at this time.  No other c/o.  Skin symptoms skin rashes are all healed.  7/11/08 Case will be closed w/medical records that accompanied report. Hospitalized 6/1-6/4/2008.  FINAL DX: Allergic reaction to varicella vaccination. Records reveal patient received varicella vaccine due to negative serology for VZV & experienced erythematous rash at injection site next day.  Then experienced neck stiffness & pain, LUE swelling, rash, sore throat, HA approx 4 wks s/p vaccinations.  Started on oral antibiotics for LUE infection day before.  Exam 5/30/08 revealed revealed tonsillar enlargement, LUE swollen, tender, erythema w/diffuse papular lesion over face, scalp, arms & trunk.  Admitted to hospital for observation for possible varicella post vaccine.  ID consult done & felt was allergic reaction, not chickenpox.  No complications & most lesions healed by d/c to home.				Y	Y	5			Y	05/16/2008				MIL	MIL		None	None  PMH: allergic penicillin (rash).			1						1	Injection site papule; Injection site rash; Rash; Tonsillitis	FLU3~AVENTIS PASTEUR~U2516AA~1~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB116AA~1~IM~LA~HEP A + HEP B (TWINRIX)~1|MMR~MERCK & CO. INC.~1310U~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|MNQ~SANOFI PASTEUR~U259AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2767AA~1~IM~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1802U~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0318747	07/11/2008	PR	37.0	37		M		ache: joint, acid reflux, anxiety, arrhythmia, high cholesterol, leg cramps, dry mouth, energy loss, muscle fatigue, gastritis, migraines, loud noises, lump in right groin, anxious, angry, irritable mood, numbness tingling fingers, pain lower back, groin, back, joint and muscle, chest, rashes, sleep problem, thirst and tiredness										10/24/2004				MIL	MIL		None	None			1						1	Abdominal mass; Anger; Anxiety; Arrhythmia; Arthralgia; Asthenia; Back pain; Blood cholesterol increased; Chest pain; Dry mouth; Fatigue; Gastritis; Gastrooesophageal reflux disease; Groin pain; Hyperacusis; Hypoaesthesia; Irritability; Migraine; Muscle fatigue; Muscle spasms; Myalgia; Paraesthesia; Rash; Sleep disorder; Thirst	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0318930	07/11/2008	MN	71.0	71		M	06/24/2008	Information has been received from a physician concerning a 71 year old male consumer who on 16-NOV-2007 was vaccinated subcutaneous with ZOSTAVAX.  Concomitant therapy included some cholesterol medications.  Subsequently, the patient experienced radicular pain on the side where he received the vaccine.  On 23-NOV-2007 the patient was back in the clinic with this pain.  He was eventually diagnosed with brachial plexopathy after further testing.  At the time of the report the patient was still weak in his arm, but was recovering.  There was no product quality complaint involved.  Follow-up information has been received from the physician concerning this 71 year old male consumer with sulfonamide and neomycin allergies who on 16-NOV-2007 was vaccinated SQ in the left arm with a first dose of ZOSTAVAX (lot # 658838/1412U).  Concomitant vaccination included an eighth dose of FLUZONE (lot #U2457AA) IM in the left arm.  There was no illness at the time of vaccination.  On 19-NOV-2007 the patient was assessed by a neurologist and diagnosed with brachial plexopathy.  An EMG in December 2007 confirmed the diagnosis.  In March 2008 the patient recovered from left brachial plexopathy according to his EMG results.  It was also reported that the patient had manifested left shoulder abductor weakness.  At the time of the report the patient was improving.  Additional information has been requested.				Y					N	11/16/2007	11/19/2007	3	Electromyography, 12/??/07, left brachial plexopathy; Electromyography, 03/??/08, resolved brachial plexopathy.	PVT	PVT	Cholesterol	Sulfonamide allergy; Allergic reaction to antibiotics			WAES0803USA03676	1						1	Brachial plexopathy; Electromyogram abnormal; Electromyogram normal; Muscular weakness	FLU3~SANOFI PASTEUR~U2457AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~1412U~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0319166	07/11/2008	NC	1.0	1	.0	M	07/03/2008	Initial and follow-up information has been received from a registered nurse concerning a 27 month old male with no medical history or allergies who had clear rhinitis and a cough at the time of vaccination, who on 20-NOV-2006 was vaccinated subcutaneously in the left arm with a 0.5 mL first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus				Y					N	11/20/2006	03/03/2008	469	None	PVT	PUB			None		WAES0803USA01238	1						1	Unevaluable event	FLU3~SANOFI PASTEUR~UT2176CA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE778AA~3~IM~~HIB (ACTHIB)~1|MMRV~MERCK & CO. INC.~1123F~1~SC~~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B08641E~4~IM~~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0319173	07/11/2008	OK	1.0	1	.0	M	07/03/2008	Initial and follow-up information has been received from a healthcare worker concerning her 12 month old son with a history of hernia surgery on 04-MAR-2008 and no drug allergies who on 14-JAN-2008 at 16:15 was vaccinated subcutaneous in the right thigh with his first 0.5 ml dose of PROQUAD (lot# 656891/0914U).  There were no illnesses at the time of vaccination.  Concomitant vaccines administered on 14-JAN-2008 at 16:15 included a second intramuscular dose of FLUZONE administered in the right leg; an intramuscular 3+2 dose of TRIHIBIT administered in the left leg; an intramuscular fourth dose of PREVNAR administered in the right leg and an intramuscular first dose of VAQTA administered in the left leg.  On 23-JAN-2008, 9 days post vaccination, the patient experienced a febrile seizure that lasted 15 minutes.  The patient was evaluated at a hospital emergency room and transported via ambulance to be admitted to another medical center on that same day.  Lab diagnostic studies included testing for two strains of Influenza and respiratory syncytial virus which were negative and a negative chest x-ray.  The patient was prescribed breathing treatments, TAMIFLU, MOTRIN, TYLENOL, XOPENEX and PULMICORT.  The patient was discharged from the hospital on 24-JAN-2008.  Subsequently, the patient recovered.  There was no product quality complaint.  Additional information is not expected.				Y	Y	0			Y	01/14/2008	01/14/2008	0	Chest x-ray, 01/23/08, negative; Diagnostic laboratory, 01/23/08, negative for influenza; Nasal aspirate RSV, 01/23/08, negative.	PUB	PUB			Herniotomy		WAES0803USA03339	1						1	Chest X-ray normal; Febrile convulsion; Influenza serology negative; Respiratory syncytial virus serology negative	DTAPH~SANOFI PASTEUR~U15656C~3~IM~LL~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~UT2474EA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0494U~1~IM~LL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~0914U~1~SC~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~854013H~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0319182	07/11/2008	TX	1.0	1	.0	M	07/03/2008	Information has been received from a physician concerning a 12-month-old male with epilepsy who on 13-DEC-2007 was vaccinated subcutaneously with a first 0.5 ml dose of PROQUAD. It was reported that 1-2 days after vaccination the patient experienced fever and seizures lasting 1-2 weeks. Unspecified medical attention was sought. The patient saw a neurologist last month (approximately March of 2008) who reported that the patient was doing fine. On an unspecified date the patient recovered. No product quality complaint was involved. Follow-up information has been received concerning a male with a history of seizures, who on 13-Dec-2007 at 1630 was vaccinated in the left thigh with a first dose of PROQUAD (lot # 05414). Concomitant vaccinations at 1630 included a fourth dose in the right thigh of PREVNAR (Lot# B540164) and FLUZONE (Lot# UT2459). Concomitant medications included TRILEPTAL. The patient had cold symptoms at the time of vaccination. It was reported that the patient was having small seizures that were lasting 1 minute. On 15-Dec-2007 at 1734 the patient had a seizure that lasted 5 minutes. He continued to have repeated seizures and was sent to the ER. The patient was observed for a day before discharge. Additional information has been requested.				Y	Y	1			Y	12/13/2007	12/14/2007	1	Unknown	PVT	PVT	Trileptal	Cold symptoms; Epilepsy	Convulsion		WAES0804USA02972	1						1	Convulsion; Pyrexia	FLU3~SANOFI PASTEUR~UT2459~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MMRV~MERCK & CO. INC.~~1~SC~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B540164~4~UN~RL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0319238	07/11/2008	PA	65.0	65		F	06/24/2008	Information has been received from an office manager concerning a 65 year old female consumer with no known allergies or pertinent medical history who on 19-DEC-2007 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant vaccination and therapy included influenza virus vaccine (unspecified) and tetanus toxoid. Subsequently, 2 weeks after vaccination on 02-JAN-2008 the patient developed shingles. The lesions were on her left buttocks. Medical attention was sought, the patient called the physician. There were no lab studies performed. At the time of the report the patient recovered on an unspecified date. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/24/2008. Medical attention was sought, the patient called the physician on 02-APR-2008. There was no product quality complaint involved. Additional information is not expected.									Y	12/19/2007	01/02/2008	14	None	PVT	PVT			None		WAES0804USA03290	1						1	Herpes zoster; Skin lesion	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~UN~UN~TETANUS TOXOID (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~1~UN~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0319585	07/11/2008	TN	63.0	63		F	06/24/2008	Information has been received from a pharmacist concerning a 64 year old female patient with no known drug allergies and a medical history of left knee replacement who was vaccinated SC with a 0.65 ml dose of zoster vaccine live (Oka/Merck) on 27-DEC-2007. It was reported that the patient also had a flu shot (unspecified therapy) on an unspecified date close to the time of the zoster vaccine live									N	12/27/2007	01/01/2008	5		OTH	OTH			left knee replacement		WAES0805USA01897	1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0320182	07/11/2008	MA	63.0	63		M	06/24/2008	Information has been received from a registered nurse concerning a 64-year-old male, with no pertinent medical history or allergies, who on 27-SEP-2007 was vaccinated subcutaneous with a single dose of zoster vaccine live (Oka/Merck) (lot # 658081/0743U). Concomitant vaccine included a dose of influenza virus vaccine (unspecified). On 31-MAR-2008 the patient developed shingles. The rash appeared on the patient's hip and buttocks and because of the pain and tenderness around the rash he has a hard time walking. The patient was seen by the physician. No diagnostic labs were performed. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. Additional information has been requested.				Y					N	09/27/2007	03/31/2008	186	None	OTH	OTH			None		WAES0804USA01440	1						1	Gait disturbance; Herpes zoster; Pain; Rash; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~0743U~UNK~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0320184	07/11/2008	PA	64.0	64		F	06/24/2008	Information has been received from a 64 year old female with asthma and a drug reaction/allergy to morphine who in November 2007, was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included influenza virus vaccine (unspecified), fluticesone propionate (+) salmeterol xinafoate (ADVAIR), albuterol sulfate (+) ipratropium bromide (DUONEB) and prednisone. In November 2007, at the same visit, the patient was vaccinated with zoster vaccine live (Oka/Merck) and influenza virus vaccine (unspecified). Ten days after the vaccinations, she had horrific rolling cramps all over her body (particularly in the legs, arm, back and ripples near the rib cage) for at least six weeks. Subsequently she consumed large amounts of water and Gatorade in hopes of having these help the cramps and pain. The patient indicated the patient was sharp, deep in the muscles or of or near the bones, random in area and time, short in duration (like 3 minutes), and very painful. She also had pain the eye. She was seen by an orthopedic who said the pain was related to the nerves and muscles. Subsequently the patient saw a neurologist who put her on gabapentin (NEURONTIN) (dose and duration not reported). The gabapentin (NEURONTIN) relieved the pain and cramps. However, she experienced delusions of stationary objects moving or swaying. The patient went off gabapentin (NEURONTIN) for five days and the delusions went away. The pain came back. It was reported a CAT scan was performed (results not provided). At the time of the report, the patient was reported as not recovered, but indicated the pain was less severe. Additional information has been requested.  09/24/2008 This is in follow-up to report(s) previously submitted on 6/24/2008. Information has been received from a 64 year old female with asthma, drug reaction/allergy to morphine and irritable bowel colitis type loose stools who on 26-OCT-2007 (previously reported as in November 2007), was vaccinated with ZOSTAVAX (Oka/Merck) (lot number 658209/1085U). Concomitant therapy included influenza virus vaccine (unspecified), ADVAIR, DUONEB, prednisone and ipratropium bromide. On 26-OCT-2007 (previously reported as in November 2007), at the same visit, the patient was vaccinated with ZOSTAVAX (Oka/Merck) and influenza virus vaccine (unspecified). Ten days after the vaccinations, she had horrific rolling cramps all over her body (particularly in the legs, arm, back and ripples near the rib cage) for at least six weeks. Subsequently she consumed large amounts of water and Gatorade in hopes of having these help the cramps and pain. The patient indicated the pain was sharp, deep in the muscles or near the bones, random in area and time, short in duration (like 3 minutes), and very painful. She also had pain in her eye. She was seen by an orthopedic who said the pain was related to the nerves and muscles. Subsequently the patient saw a neurologist who put her on NEURONTIN (dose and duration not reported). The NEURONTIN relieved the pain and cramps. However, she experienced delusions of stationary objects moving or swaying. The patient went off the NEURONTIN for five days and the delusions went away. The pain came back. It was reported a CAT scan was performed (results not provided). At the time of the report, the patient was reported as not recovered, but indicated the pain was less severe. Follow-up information was received on 21-JUL-2008 in the form of medical records from the responsible physician. It was reported that on 26-OCT-2007 the patient had an office visit with her primary physician to follow-up on her asthma. It was noted that her chemistries were satisfactory and her lipids were to goal. She was reassured about her asthma and was given a prescription for ipratropium via a nebulizer and was also given a vaccination of ZOSTAVAX (Oka/Merck) 0.65 ml, SC, right arm (lot # 658209/1085U) and flu shot. On 16-NOV-2007 the patient had an office visit for the complaints of shooting pains not in her joints, but seemingly in her bones. She in fact saw another physician the week before, who felt this was not an orthopedic issue, but possibly some sort of the neuropathy. The patient started with this on approximately 12-OCT-2007 about five weeks ago and it was in her right shin initially. But as of 16-NOV-2007 she was having in the number of different locations in her arm and legs and a couple of shooting pains in her head happening as often as four times a day then. Unfortunately, the pain only lasted 30 to 60 seconds, but was very intense. The patient had never had this before. She had had no medication change and was otherwise well. She apparently had done a little reading on this and was wondering about the possibility of multiple myeloma. The neurologic exam was grossly intact and there was no evidence of any synovitis or skin changes. Assessment indicated a very atypical presentation of multiple myeloma with her previously normal protein and calcium. The physician stated that it seemed unlikely but was reasonable to check an immunoprotein electrophoresis and a complete blood count and sedimentation rate (results not provided). In addition the patient was to see the neurologists. On 11-JAN-2008 the patient had an office visit with her primary physician due to a pretty severe lancinating pain in the patient's long bones which persisted and was limiting in her work. She also got some muscle cramps. She had apparently felt very dissatisifed with her neurologic consultation that was given. She had been going to a chiropractor who was equally frustrated, feeling that there had to be some metabolic issue. The patient had tried the ULTRAM and TYLENOL without much relief. She sometimes woke up in the night with the pain. She did have a long history of irritable bowel colitis type loose stools and wondered about electrolyte imbalance. The physician noted that some labs had been done previously and there was really no change in the exam, but clearly the patient was in a lot of discomfort with this and looked pretty frazzled. The workup thus far unfortunately did not give the physician any clue, possibility of electrolyte disturbances certainly wanted to consider, but the physician do not think likely. The patient did have a family history of rheumatoid arthritis. This was certainly again not the clinical picture of that either, but the physician was really not certain on what to pin this, and would like to get yet another opinion especially given the limited information gleaned from neurology. The patient was to see a rheumatologist and the patient's electrolytes would be checked (no results provided). On 28-JAN-2008 the patient had another follow-up visit with her primary physician who noted that the symptoms had not gone. All those seemed to be bothersome. The patient now felt more hypersensitive to touch in the number of places and continued to have generalized pain as well as dull headache. The physician again reviewed her history with the onset initially of the shooting bone pain and a dull headache. At that time, that became generalized. All over her pain that was quite severe associated with a muscular spasm in her face and at the time of follow-up some subsiding to the more rolling muscle spasms and hyperesthesia that she described that day. The physician explained again that the whole picture had been atypical. The neurologist did not feel there was any apparent neurologic disease and ruled out Lyme disease and her labs had been unrevealing. She did however due to the history that recognized on October 26. She received her ZOSTAVAX (Oka/Merck) and her symptoms started about 11:10. Her neuro exam remained intact. The physician's assessment was as follows: He was still have lost account for this and unfortunately have not heard back from the rheumatologists consultation point may not, but it does seem not inconceivable, but this could be an unusual adverse effect from the ZOSTAVAX (Oka/Merck). She was to be tried on NEURONTIN to see if it would afford her some type of relief. She was started on 100 mg a day for three days, 300 mg twice a day and then work up to 300 mg three times a day. She was to also proceed with a rheumatology appointment as soon as possible. On 03-MAR-2008, the patient had a follow-up visit with her primary physician and reported feeling 100% better 3 days after starting gabapentin. There were no side effects after first few days. BP 136/74, Pulse 64, Temp 97.2 degrees F, Wt 158 lbs. No results in previous 1 Week(s) from current visit. Latest known result is: Lyme Disease Antibody Screen (INDEX) 21-JAN-2008 Value <0.91 Status: Final. The rest of the physician exam was without any abnormalities. The plan was to discontinue gabapentin over the next three weeks. At the time of the report, the patient was not recovered from the reported adverse events. Additional information is not expected.				Y					N	10/26/2007			computed axial - results not provided; neurlogical examination, 11/16/07, Grossly intact and there was no evidence of any synovitis or skin changes.; neurological examination, 01/28/08, Remains intact. Her vitals as noted.; Lyme disease assay, 01/21/08, <0.91 Status: Final; blood chemistry, 10?/??/07, Satisfactory; serum lipoproteinial, 10?/??/07, at goal	OTH	OTH	DUONEB; ADVAIR; prednisone; ipratropium bromide	Asthma, Drug hypersensitivity; Loose stools			WAES0804USA01396	1						1	Borrelia burgdorferi serology; Computerised tomogram; Delusion; Delusional perception; Eye pain; Hyperaesthesia; Laboratory test normal; Lipoprotein (a); Muscle spasms; Muscle spasms; Myalgia; Neuralgia; Neurological examination normal; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~1085U~UNK~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0319040	07/15/2008	FL	1.0	1	.0	F	07/10/2008	Patient received the varicella vaccine on 10/31/06.  She was seen on 7/10/08 for chicken pox.									Y	10/31/2006	07/10/2008	618		PVT	PVT		None	None			1						1	Varicella; Varicella post vaccine	FLU3~SANOFI PASTEUR~U2174EA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~AHAVB133AA~1~IM~LL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~1134R~1~IM~RA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA		Influenza
0319068	07/15/2008	PR	20.0	20		M	07/15/2008	Extreme headaches every other day for approx. 1 minute then goes away since late 2003. Loss of hair (began losing hair approx. 3 months after receiving those vaccines). Evacuate blood from time to time. I currently have Anthrax 1, 2 and 3 not because I wanted but because was a must to have them.				Y					N	11/02/2003	11/20/2003	18		MIL	MIL		None	None	Extreme Headaches~Anthrax (Biothrax)~1~20.20~Patient		1						1	Alopecia; Headache; Rectal haemorrhage	ANTH~EMERGENT BIOSOLUTIONS~Unknown~1~IM~UN~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~Unknown~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~ENG5444A4~1~IM~UN~HEP B (ENGERIX-B)~1|SMALL~PFIZER\WYETH~4020074~1~~UN~SMALLPOX (DRYVAX)~1|TYP~SANOFI PASTEUR~W09092~1~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0319082	07/16/2008	IL	0.6	0	.6	M	07/15/2008	At 6 months of age my son recvd the following vaccines.  DTaP 1, Hib1-Hep B1, IPV1, & a Flu shot. Loose stool began daily with periods of crying daily, difficulty sleeping within 24 to 72 hours of these vaccinationsbeing given. Eye contact decreased. Development stopped progressing. Poor eating habits. I expressed concern to  pediatrician of loose stool 3 times in 6-8 month time period, I am advised that my son is drinking to much formula and other liquids. GI functioning poorly.  I consult with two GI Doctors with little direction.  Neurological delays confirmed and diagnosed as autism at 22 months. My son has been confirmed to have high levels of Lead and Mercury. 9/22/2008 PCP records received. 7 month WCC 10/20/2004. Parental concerns re: not bottle holding or sitting yet. Developmental screening to be scheduled. Recieved 1st set of vax.  Seen 9/7/05 for 12 month WCC at age 17 months.  Parental concerns re: development. Concerns for speech at age 22 months.  7/17/08 Developmental eval received from parent dated 2/20/06 with Diagnostic Impression:  Global Developmental Delays. Impairments in Social Interaction. Childhood Autism Rating Scale placed child in the moderate range of the Autism Spectrum. F/U visit 2/21/07 with Diagnostic Impression Autism.  Global Developmental Delays 7/17/08 Developmental eval received from parent dated 2/20/06 with Diagnostic Impression:  Global Developmental Delays. Impairments in Social Interaction. Childhood Autism Rating Scale placed child in the moderate range of the Autism Spectrum. F/U visit 2/21/07 with Diagnostic Impression Autism.  Global Developmental Delays.								Y	N	10/20/2004	10/21/2004	1	Comprehensive Parasitology stoolx3- Results imbalance in Bacteriology and Moderate Yeast/Candida. Urinary Porphyrin Test- Results: Elevated levels of Mercury and Lead.  Viral tests-Results: Highly elevated Hepatitis B, elevated.	UNK	UNK	NONE	NONE	NO PRE-EXISTING CONDITIONS OF ANY KIND.			1						1	Autism; Crying; Developmental delay; Diarrhoea; Disturbance in social behaviour; Eating disorder; Fungus stool identified; Gastrointestinal disorder; Hepatitis B antibody positive; Insomnia; Lead urine increased; Parasite stool test; Stool analysis abnormal; Urine mercury abnormal	DTAP~SANOFI PASTEUR~U1290CA~1~IM~LL~DTAP (DAPTACEL)~1|DTPIPV~SANOFI PASTEUR~X1040~1~IM~LL~DTP + IPV (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U1410BA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~1113N~1~IM~RL~HIB + HEP B (COMVAX)~1	USA	Disabling	Influenza
0319404	07/16/2008	MA				M	06/25/2008	A non-serious spontaneous report or INFLUENZA LIKE ILLNESS, FEVER, CONJUNCTIVITIS, DRY COUGH and MUSCLE ACHE has been received from a  physician concerning a male child subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither past medical history nor concomitant medications have been reported. The patient received FluMist vaccine intranasally on an unknown date. Three to four days later, the patient developed an influenza-like illness with fever up to 105, conjunctivitis, dry cough and muscle aches. The reported events lasted for about five days.									Y					OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0006914	1						1	Conjunctivitis; Cough; Influenza like illness; Myalgia; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0319458	07/17/2008		66.0			F	07/16/2008	Information has been received from a health professional concerning a 66 year old female was vaccinated with PNEUMOVAX 23. Concomitant therapy included influenza virus vaccine (unspecified). Subsequently the patient experienced miller-fisher variant of guillain barre syndrome and was hospitalized. The patient was presented to the hospital on October 21, 2007, after progressively worsening neurological complaints. The patient stated that she had onset of headaches a week or so before admission, soon associated with some numbness and tingling in her hands and feet, and later associated with dysarthria and swallowing difficulties, prompting her to get further medical attention in the emergency room. The patient had no viral-type illnesses; however, a week or so before symptom onset, she had a flu shot as well as PNEUMOVAX 23. The patient was evaluated by neurology with multiple tests. MRI and MRA scans demonstrated no significant abnormality that could have caused her symptoms. With the patient's history, physical, and diagnostic testing done, she was diagnosed with Miller-Fisher variant of Guillain-Barre syndrome. The patient was treated with intravenous immunoglobulin. At this point, the patient noted stability in her course, no worsening, but had not noted much improvement either. Overall, she felt somewhat weaker on the left versus the right, but noted significant difficulties with coordinating her movements. She also noted residual numbness and tingling involving her face, the inside of her mouth, in her lower extremities in a knee sock-type distribution and in a glove distribution in the upper limbs. She did admit to facial weakness with some dysarthria; however, noted improvement in her face and in her speaking. She was experiencing some intermittent bouts of pain. She had pain in her limbs, particularly her legs, described as a combination of burning pain, cramping, and irritating numbness and tingling. The patient was on gabapentin. The patient also developed what she called spells, where she experienced an autonomic instability giving her a 3- to 10-minute period of dizziness, change in vision, headache, and hypotension. The patient was previously fully independent with activities of daily living as well as ambulation. She had no medical limitations. On physical examination, the patient had difficulty in her feet with digit identification as well as proprioception, which was absent at her toes. Light touch sensation was decreased beginning at about mid thigh level and gradually worsening down to her toes. Upper extremity sensation was not as markedly decreased as in her feet, but there was decreased light touch sensation in bilateral hands as well as decreased vibratory sensation. Myoclonus was present bilaterally in both lower extremities. Rotational dystonia was also present in her ankles, more pronounced on her left side. Digic identification was intact in her hands. With manual muscle testing in general she had 4/5 strength in her limbs, with hand intrinsic being weaker, but she was able to give some minimal resistance with intrinsic testing. Reflexes were obtained at her ankles, 1+ at the knees, and 1+ in her upper extremities. Extraocular movements were intact. No nystagmus was noted. Mild facial weakness was noted bilaterally. Her speech was mildly dysarthric. here was significant ataxia with attempts at gross as well as fine motor movements, more pronounced in the lower extremities versus the upper extremities. Comment: It should be clear from the case that the diagnosis is Guillain-Barre syndrome (GBS) from the findings of her rapidly progressive ascending limb weakness, accompanied by paresthesias, pain, and cranial nerve dysfunction. However, there are many subdivisions of GBS, all of which appear to be autoimmune diseases resulting from aberrant immune responses against various components of peripheral nerve fibers. The acute symptoms of ataxia, ophthalmoplegia, and decreased reflexes confirmed her history of the rare variant Miller Fisher syndrome (MFS), which is observed in about 5% of all GBS cases. 'Acute onset of external ophthalmoplegia is a cardinal MFS feature.' The ataxia tends to be out of proportion to the degree of sensory loss. Patients may also have mild weakness, prosis, facial palsy, or bulbar palsy. With MFS, the underlying pathology is unclear because of the affected portions of the nervous system cannot be biopsied and autopsies do not occur since it is a benign disorder. The usual course is one of gradual and complete recovery over weeks to months. A close association exist between antiganglioside antibodies and the Miller Fisher variant. Ant-GQ1b antibodies have a relatively high specificity and sensitivity for the disease. Dense concentrations of GQ1b ganglioside are found in the oculomotor, uochlear, and abducens nerves, which may explain the relationship between anti-GQ1b antibodies and ophthalmoplegia. Our patient's risk factor that was believed to have led to her disease was the influenza and/or PNEUMOVAX vaccination a week prior to the symptoms. Recent influenza immunization has been associated with GBS. One study reviewed the cases of GBS during the 1992-1993 and 1993-1994 influenza seasons and found an adjusted relative risk of 1.7 cases per 1 million influenza vaccination. The Vaccine Adverse Event Reporting System, which is administered by the Centers for Disease Control and Prevention and the US Food and Drug Administration co monitor reports of suspected adverse events after immunization, concluded in its 2003 surveillance summary that the risk of developing vaccine-associated GBS is less than the risk of severe influenza. In addition, despite increasing doses of administered vaccine during the 4 previous influenza seasons, the number of GBS reports has remained stable. In conclusion GBS (acute inflammatory demyelinating polyradiculoneuropathy) is the most common cause of acute progressive flaccid paralysis. The variant MFS is a rare disorder with rapidly evolving ataxia, areflexia, mild limb weakness, and ophthalmoplegia. Sensory loss is unusual, but proprioception may be impaired. Demyelination and inflammation of cranial nerves III and VI, spinal ganglia, and peripheral nerves occur. Also, reduced or absent sensory nerve action potentials, tibal H reflex is usually absent. Resolution occurs in 1 to 3 months.' No further information is available. A copy of the literature article is attached as further documentation of the patient's experiences.					Y	0	Y		U					OTH	OTH			Unknown		WAES0807USA02261	1						1	Asthenia; Ataxia; Blood product transfusion; Burning sensation; Coordination abnormal; Cranial nerve disorder; Dizziness; Dysarthria; Dysphagia; Dystonia; Facial paresis; Headache; Hypoaesthesia; Hypotension; Loss of proprioception; Miller Fisher syndrome; Myoclonus; Neurological symptom; Nuclear magnetic resonance imaging normal; Pain in extremity; Pallanaesthesia; Paraesthesia; Sensory loss; Visual disturbance; Ataxia; Dizziness; Dysarthria; Dysphagia; Dystonia; Facial paresis; Gait disturbance; Headache; Hypoaesthesia; Hypotension; Miller Fisher syndrome; Movement disorder; Muscle spasms; Myoclonus; Neurological symptom; Nuclear magnetic resonance imaging; Pain; Pain in extremity; Paraesthesia; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0319510	07/17/2008	AZ	67.0	67		F	07/16/2008	Patient received shingles vaccine on 10/25/07. On approximately 04/22/08 identified recurrence of shingles rash. On 4/24/08 patient went to private physician for treatment of herpes rash - Famciclovir - herpes rash subsided 1st week of June. This is in follow-up to report (s) previously submitted on 9/24/2008. The patient recovered from shingles. The patient sought medica attention. The reporter did not express interest in the VZV analysis by PCR. No further information is available.				Y					Y	10/25/2007	04/22/2008	180	none	OTH	OTH	Accuprel; HCTZ Daily	none	hypertension; shingles			1						1	Herpes zoster; Rash vesicular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA311BA~1~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|VARZOS~MERCK & CO. INC.~1085U~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0319968	07/17/2008	AL	13.0	13		F	07/15/2008	Information has been received from a registered nurse (RN) through a Merck pregnancy registry concerning a 13 year old female with attention deficit/hyperactivity disorder and no known drug allergies and a history of being a rape victim who on 15-OCT-2007 was vaccinated intramuscularly in the right deltoid with a first 0.5 ml dose of GARDASIL vaccine (yeast) (Lot #655849/0263U). On the same day the patient also received concomitant vaccinations of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA), hepatitis A virus vaccine (manufacturer unknown) and influenza virus vaccine (unspecified). The patient was in her menstrual cycle at the time of vaccination. On 15-JUN-2008 the patient had a normal live birth, female child. Unspecified medical was sought. Additional information has been requested.									U	10/15/2007	10/15/2007	0	Unknown	OTH	OTH		Pregnancy NOS, Attention deficit/hyperactivity disorder	Rape victim, LMP = 10/15/2007		WAES0806USA03719	1						1	Drug exposure during pregnancy	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~MERCK & CO. INC.~~UNK~UN~UN~HEP A (VAQTA)~1|HPV4~MERCK & CO. INC.~0263U~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0262657	07/18/2008	CA	18.0			M	03/19/2008	Initial report received on 07 March 2008 from the Division of Vector-Borne Infectious Disease, National Center for Infectious Diseases, Centers for Disease Control VAERS ID # 262657.  A search of the CDC VAERS database was completed on 13 March 2008 which also revealed additional information for this case.  This case involves an 18-year-old male military recruit, whose past medical history included a cough, and exposure to other recruits with diarrhea, but no history of diarrhea since arrival to the military base on 02 August 2006.  The patient has an allergy to penicillin, but had not other illness, or past medical issues (specifically hypertension, thyroid disorder, diabetes, or epilepsy).  He also had no caffeine, tobacco, or alcohol use.  On 02 August 2006, the patient received a dose of MENOMUNE (lot #, route and site of administration not provided); a dose of MMR vaccine (trade name, manufacturer name, route and site of administration not provided); a dose of a pneumococcal vaccine (trade name, manufacturer name, route and site of administration not provided); and a first dose of TWINRIX (manufacturer GSK, route and site of administration not provided).  On 29 August 2006 the patient subsequently received a first, subcutaneous, left arm dose of YF-VAX (lot # VEG01AA); a first, subcutaneous, right arm dose of IPOL (lot # Y1051); a first, intramuscular, right arm dose of ADACEL (lot # C2457AA); a first, intranasal dose of FLUMIST (lot # 500430P), manufacturer Medimmune, Inc./Wyeth Laboratories, Inc.); and a second, intramuscular, left arm dose of TWINRIX (lot # AHABB061AA, manufacturer GlaxoSmithKline).  On 30 August 2006, the patient developed progressive ascending weakness in his hands and feet bilateral, with gait disturbance, numbness, pins and needles, intermittent tingling of feet, and calf pains.  He had no fever, rash, headache, stiff neck, diplopia, trouble breathing or swallowing, dysuria, or incontinence.  Physical examination revealed an awake, alert and oriented patient.  Examination of the neck was normal, and neurological examination revealed normal cranial nerves II-XII, no sensory abnormalities, normal muscle tone and bulk, and normal strength of face and neck/cervical spine.  The patient had decreased strength of the upper (4/5) and lower (3/5) extremities.  He had asthenia, was unable to walk unassisted, abnormal biceps and brachioradialis (1+) reflexes, absent or diminished ankle jerk, and knee jerk was normal.  The patient's toes were flaccid with Babinski testing.  The patient was subsequently admitted to the intensive care unit in the hospital on 02 September 2006, and his respiratory status was monitored with frequent pulmonary function tests.  He did not require intubation or other respiratory support.  Treatment included HEPARIN, and IVIG 42 gm daily for three days.  Diagnostic laboratory studies revealed a lumbar puncture test that was negative for albuminocytologic dissociation but cultures and PCR were pending at the time of this report.  An EMG (electromyogram) revealed electrophysiologic evidence of a severe motor, greater than sensory, acquired multifocal sensorimotor peripheral neuropathy with axonal, greater than demyelinating features.  Per the reporter, given the history of the patient, this likely represented a variant of GBS (Guillain-Barre syndrome).  Yellow fever studies revealed evidence of recent vaccination with yellow fever vaccine.  No yellow fever viral RNA was detected by Taq Man RE-PCR, and IgM Capture ELISA was negative for all serum samples.  PRNT (+Control >2560) was <10 for serum sample #1, 10 for Serum sample #2, 10 for Serum sample #3, 20 for Serum sample #4, 20 for serum sample #5, 10 for serum sample 36.  The patient was discharged after five days of hospitalization.  Recovery status at the time of this report was unknown.					Y	5			U	08/29/2006	08/30/2006	1	Diagnostic laboratory studies revealed a lumbar puncture test that was negative for albuminocytologic dissociation.  Cultures and PCR were still pending at the time of this report.  An EMG (electromyogram) revealed electrophysiologic evidence of a severe motor greater than sensory acquired multifocal sensorimotor peripheral neuropathy with axonal greater than demyelinating features.  Frequent pulmonary function tests.  Result not provided.  Yellow fever studies revealed evidence of recent vaccination with yellow fever vaccine.  No yellow fever viral RNA was detected by Taq Man RE-PCR, and IgM Capture ELISA was negative for all serum samples.  PRNT (+Control >2560) was <10 for serum sample #1, 10 for Serum sample #2, 10 for Serum sample #3, 20 for Serum sample #4, 20 for serum sample #5, 10 for serum sample #6.	UNK	UNK	NONE	The patient had no concurrent illness except for a cough and exposure to other recruits with diarrhea, but no history of diarrhea since arrival to the military base on 02 August 2006.	The patient had no concurrent illness except for a cough and exposure to other recruits with diarrhea, but no history of diarrhea since arrival to the military base on 02 August 2006.  Past medical history included allergy to penicillin, but no other illness, or past medical issues (specifically hypertension, thyroid disorder, diabetes, or epilepsy), and he had no caffeine, tobacco, or alcohol use.	No adverse effect~Hep A + Hep B (no brand name)~1~18.00~In Patient	200800753	1						3	Areflexia; Asthenia; Axonal neuropathy; Blood immunoglobulin M; Blood test normal; Dyskinesia; Electromyogram abnormal; Extensor plantar response; Gait disturbance; Hypoaesthesia; Hypotonia; Immunology test; Lumbar puncture normal; Muscular weakness; Pain in extremity; Paraesthesia; Peripheral sensory neuropathy; Physical examination normal; Areflexia; Asthenia; Babinski reflex test; Culture; Electromyogram abnormal; Gait disturbance; Grip strength decreased; Hypoaesthesia; Hypotonia; Immunology test; Immunology test normal; Joint range of motion decreased; Lumbar puncture normal; Muscular weakness; Neurological examination normal; Neuropathy peripheral; Pain in extremity; Paraesthesia; Polymerase chain reaction; Pulmonary function test; Viral test negative; Asthenia; Blood product transfusion; CSF cell count normal; CSF protein increased; Electromyogram abnormal; Fatigue; Guillain-Barre syndrome; Impaired work ability; Neuropathy peripheral; Pain in extremity; Quadriparesis; Abasia; Areflexia; Asthenia; Axonal neuropathy; Babinski reflex test; Blood product transfusion; CSF culture; Electromyogram abnormal; Gait disturbance; Grip strength decreased; Guillain-Barre syndrome; Hypoaesthesia; Immunology test; Intensive care; Lumbar puncture; Lumbar puncture normal; Muscular weakness; Pain in extremity; Paraesthesia; Peripheral sensorimotor neuropathy; Polymerase chain reaction; Pulmonary function test; Reflexes abnormal; Serology normal	FLUN3~MEDIMMUNE VACCINES, INC.~500430P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|IPV~SANOFI PASTEUR~Y1051~1~SC~RA~POLIO VIRUS, INACT. (IPOL)~2|TDAP~SANOFI PASTEUR~C2457AA~1~IM~RA~TDAP (ADACEL)~2|YF~SANOFI PASTEUR~VEG01A~1~SC~LA~YELLOW FEVER (YF-VAX)~2|FLUN3~MEDIMMUNE VACCINES, INC.~500430P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB061AA~2~IM~LA~HEP A + HEP B (TWINRIX)~3|IPV~SANOFI PASTEUR~Y1051~1~SC~RA~POLIO VIRUS, INACT. (IPOL)~3|TDAP~SANOFI PASTEUR~C2457AA~1~IM~RA~TDAP (ADACEL)~3|YF~SANOFI PASTEUR~VEG01A~1~SC~LA~YELLOW FEVER (YF-VAX)~3|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~4|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~HEP A + HEP B (TWINRIX)~4|IPV~SANOFI PASTEUR~~UNK~UN~UN~POLIO VIRUS, INACT. (IPOL)~4|TDAP~SANOFI PASTEUR~~UNK~UN~UN~TDAP (ADACEL)~4|YF~SANOFI PASTEUR~~UNK~UN~UN~YELLOW FEVER (YF-VAX)~4|FLUN3~MEDIMMUNE VACCINES, INC.~500430P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~5|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB061AA~2~IM~LA~HEP A + HEP B (TWINRIX)~5|IPV~SANOFI PASTEUR~Y1051~1~SC~RA~POLIO VIRUS, INACT. (IPOL)~5|TDAP~SANOFI PASTEUR~C2457AA~1~IM~RA~TDAP (ADACEL)~5|YF~SANOFI PASTEUR~VEG01A~1~SC~LA~YELLOW FEVER (YF-VAX)~5	USA	Hospitalisation	Influenza
0303733	07/18/2008		19.0			M	03/19/2008	This case was received from the Centers for Disease Control and Prevention (CDC), Yellow Fever Working Group, on 07 March 2008.  A 19-year-old male military recruit received the following vaccines on 16 September 2007: MMR, polysaccharide pneumococcal vaccine, and meningococcal vaccine (manufacturers and lot numbers not provided). Prior to vaccination he had been in excellent health, other than a brief episode the previous summer of sore throat and fever (up to 105 degrees), later attributed to viral illness.  On 08 October 2007, he presented with sore throat, congestion, and purulent cough; a physical exam revealed swollen tonsils, and a chest x-ray was negative.  Treatment included CEPACOL, pseudoephedrine extended release, TYLENOL, guaifenesin, oxymetazoline spray, and a MAALOX/lidocaine/BENADRYL gargle.  Symptoms improved over a few days.  On 16 October 2007 he complained of of a pruritic rash, which appeared primarily on his trunk and T-shirt area.  He was diagnosed with urticaria, due to use of a new fabric softener, and treated with BENADRYL.  Later that day he received the following vaccines: YF-VAX (lot number UE912AA), IPOL (lot number Z0421), Td toxoid (sanofi-pasteur, lot number reported as AC52B024AA), TWINRIX (GlaxoSmithKline, lot number AHABB100AA), and FLUMIST (Medimmune, lot number 500485P, inhaled).  On 19 October 2007, three days after vaccination, he complained of watery nasal discharge, shortness of breath with exertion, temperature of 100.5 F, and headache.  A repeat chest x-ray was negative, and he was treated with TYLENOL, CEPACOL, guaifenesin, pseudoephedrine LA, and TESSALON.  On 26 October 2007, ten days after vaccination, the patient complained of headache and neck stiffness.  He became lethargic and unresponsive, and collapsed.  He was taken to a clinic, where his temperature was noted to be 102.3 F.  His Glasgow Coma scale rating went from a score of 14 (on a scale of 3 to 15) to 10, with incontinence.  He underwent a lumbar puncture, and cerebrospinal fluid (CSF) WBC was found to be 2240 with 82% polys (polypmorphonuclear leukocytes). He was treated with 1gm of ROCEPHIN, 2 gm of ampicillin, acyclovir, and dexamethasone, and then evacuated by air to a nearby medical center with a presumed diagnosis of meningitis.  He was admitted to the intensive care unit, where additional treatment included vancomycin and rifampin.  A lumbar puncture reported on 27 October 2007 noted the CSF to be clear, with glucose 87 (normal 40-70), protein 66 (normal 12-60), WBC 75 (normal 0-8), RBC 98 (normal 0), diff PMN 19%, L 28%, mono 53%.  Gram stain was negative for organisms, initial meningococcal and S. pneumoniae antigen tests were negative, and cultures showed no growth after three days.  PCR tests on CSF for herpes simplex viruses (HSV1 and HSVZ), varicella-zoster virus, and HMV6 were also negative.  Additional testing performed showed the following: Serum test WNV <0.5, IgM 0.03, Epstein Barr Virus (IPA) >10, Epstein Barr Virus Nuclear Antigen >10, mycoplasma IGM negative, and Parvovirus B-19 IgM (IPA acute serum) <10.  Chemistry profile revealed: sodium 132 (normal 136-144), potassium 3.3 (normal 3.6-5.1), chloride 98 (normal 101-111), BUN 5 (normal 8-26), Creatinine 0.6 (normal 0.7-1.2), serum cortisol was 1.50.  Complete blood count showed: hemoglobin 13.8, hematocrit 40.6, and white blood count 9.4.  Throat swab was negative for Influenza A and B, human metapneumovirus, RSV type A, enterovirus, and mycoplasma.  A CT with contrast on 27 October 207 showed only right sphenoid sinus disease, with no evidence of meningeal enhancement, intracranial hemorrhage, or parenchymal masses.  An MRI on 29 October 2007 showed diffuse white matter increased signal without enhancement, a pattern most suggestive of ADEM.  This pattern could also be seen in the setting of Lyme disease.  Serum Lyme titer drawn 31 October 2007 was positive (45 kd IgG reactive), but IgM was negative (nonreactive).  The patient's mental status slowly improved, and after two days he was able to transfer out of the ICU.  He remained hospitalized until 05 November 2007, at which time he was considered to be recovered to near baseline capacity.  The discharge diagnosis was acute disseminated encephalomyelitis (ADEM).  On 20 November 2007, the patient was seen by an infectious disease specialist as an outpatient.  The consulting physician felt that ADEM was the probable diagnosis, in the setting of recent upper respiratory infection and recent vaccination, and that the specific infectious etiology had not yet been identified.  The patient was scheduled to undergo testing to ascertain yellow fever IgM levels; all testing was negative.   Additional testing by the CDC detected no yellow-fever antibody post-vaccination, and no virus was isolated in the serum.  RPR (rapid plasma reagin) was also negative.  On 21 November 2007 the patient had a follow-up appointment with a neurologist, at which time the patient stated that he was back to about 75% cognitively, with complaints of forgetfulness, difficulty concentrating, and slight weakness in the arms, legs, and hand grip.  He also complained of decreased sensation in the fingers.  Complete neurologic exam was normal, and he was referred for neurocognitive testing.  This testing was performed on 28 November 2007, and revealed average to above-average results in all areas except verbal fluency, which was below average.  During an evaluation in the center on 30 November 2007, the patient continued to complain of slight weakness and difficulty concentrating.  A quality of life self-assessment, performed on 03 December 2007, revealed slight decrements in perceived physical function, physical role, vitality, and physical component summary scales.					Y	11			N	10/16/2007	10/19/2007	3	26/Oct/2007: He underwent a lumbar puncture, and cerebrospinal fluid (CSF) WBC was found to be 2240 with 82% polys (polypmorphonuclear leukocytes).  A lumbar puncture reported on 27 October 2007 noted the CSF to be clear, with glucose 87 (normal 40-70), protein 66 (normal 12-60), WBC 75 (normal 0-8), RBC 98 (normal 0), diff PMN 19%, L 28%, mono 53%.  Gram stain was negative for organisms, initial meningococcal and S. pneumoniae antigen tests were negative, and cultures showed no growth after three days.  PCR tests on CSF for herpes simplex viruses (HSV1 and HSVZ), varicella-zoster virus, and HMV6 were also negative.  Additional testing performed showed the following: Serum test WNV <0.5, IgM 0.03, Epstein Barr Virus (IPA) >10, Epstein Barr Virus Nuclear Antigen >10, mycoplasma IGM negative, and Parvovirus B-19 IgM (IPA acute serum) <10.  Chemistry profile revealed: sodium 132 (normal 136-144), potassium 3.3 (normal 3.6-5.1), chloride 98 (normal 101-111), BUN 5 (normal 8-26), Creatinine 0.6 (normal 0.7-1.2), serum cortisol was 1.50.  Complete blood count showed: hemoglobin 13.8, hematocrit 40.6, and white blood count 9.4.  Throat swab was negative for Influenza A and B, human metapneumovirus, RSV type A, enterovirus, and mycoplasma.  A CT with contrast on 27 October 207 showed only right sphenoid sinus disease, with no evidence of meningeal enhancement, intracranial hemorrhage, or parenchymal masses.  An MRI on 29 October 2007 showed diffuse white matter increased signal without enhancement, a pattern most suggestive of ADEM.  This pattern could also be seen in the setting of Lyme disease.  Serum Lyme titer drawn 31 October 2007 was positive (45 kd IgG reactive), but IgM was negative (nonreactive).	UNK	UNK	CEPACOL, pseudoephedrine extended release, TYLENOL, guaifenesin, oxymetazoline, MAALOX/lidocaine/BENADRYL gargle, BENADRYL		Brief episode of sore throat with temperature to 105 the previous summer (thought to be viral).  On 08 October 2007 presented with sore throat, congestion, purulent cough.  On 16 October 2007 he presented with a pruritic rash, thought to be urticaria.		200800754	1						2	CSF culture negative; CSF glucose increased; CSF protein normal; Cognitive disorder; Dysarthria; Enterovirus serology test negative; Fatigue; Haematocrit; Haemoglobin; Laboratory test normal; Leukoencephalomyelitis; Musculoskeletal stiffness; Nuclear magnetic resonance imaging brain abnormal; Polymerase chain reaction; Protein total; Red blood cell count; Serology positive; Stupor; Tremor; Urinary incontinence; White blood cell count normal; Bacterial test negative; Blood chloride decreased; Blood cortisol decreased; Blood creatinine decreased; Blood homocysteine; Blood potassium decreased; Blood sodium decreased; Blood urea decreased; Body temperature increased; Borrelia burgdorferi serology; CSF cell count normal; CSF glucose increased; CSF protein increased; CSF white blood cell count increased; Computerised tomogram abnormal; Culture negative; Culture throat negative; Disturbance in attention; Dyspnoea; Enterovirus serology test negative; Epstein-Barr virus antibody positive; Full blood count; Glasgow coma scale; Gram stain negative; Granulocyte count increased; Grip strength decreased; Haematocrit decreased; Haemoglobin decreased; Headache; Incontinence; Laboratory test abnormal; Lethargy; Leukoencephalomyelitis; Lumbar puncture; Lymphocyte percentage; Mechanical ventilation; Memory impairment; Metapneumovirus infection; Monocyte percentage increased; Muscular weakness; Musculoskeletal stiffness; Neurological examination normal; Nuclear magnetic resonance imaging abnormal; Parvovirus B19 serology; Polymerase chain reaction; Red blood cells CSF positive; Respiratory syncytial virus serology; Rhinorrhoea; Sensory loss; Syncope; Unresponsive to stimuli; Varicella zoster serology negative; Viral test negative; Virus serology test negative; White blood cell count normal; Antibody test negative; Blood chloride decreased; Blood cortisol decreased; Blood creatinine decreased; Blood culture negative; Blood glucose increased; Blood immunoglobulin M; Blood potassium decreased; Blood sodium decreased; Blood urea decreased; Body temperature increased; Borrelia burgdorferi serology positive; CSF cell count increased; Chest X-ray normal; Computerised tomogram abnormal; Culture negative; Culture throat negative; Disturbance in attention; Dyspnoea; Epstein-Barr virus antibody positive; Glasgow coma scale; Gram stain negative; Haematocrit normal; Haemoglobin decreased; Headache; Herpes simplex serology; Incontinence; Lethargy; Leukoencephalomyelitis; Lumbar puncture; Lymphocyte percentage; Mechanical ventilation; Meningitis; Monocyte percentage increased; Muscular weakness; Musculoskeletal stiffness; Mycoplasma serology; Neurological examination normal; Nuclear magnetic resonance imaging abnormal; Parvovirus B19 serology; Pharyngolaryngeal pain; Productive cough; Protein total increased; Pyrexia; Rash pruritic; Red blood cell count increased; Respiratory tract congestion; Rhinorrhoea; Sensory loss; Syncope; Syphilis test negative; Tonsillar hypertrophy; Unresponsive to stimuli; Varicella zoster serology negative; Viral infection; White blood cell count increased; White blood cell count normal; Yellow fever	FLUN3~MEDIMMUNE VACCINES, INC.~500485P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB100AA~1~UN~UN~HEP A + HEP B (TWINRIX)~1|IPV~UNKNOWN MANUFACTURER~Z0421~1~UN~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~1|TD~SANOFI PASTEUR~AC52B024AA~1~UN~UN~TD ADSORBED (NO BRAND NAME)~1|YF~SANOFI PASTEUR~UE912AA~1~UN~UN~YELLOW FEVER (YF-VAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500485P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB100AA~UNK~UN~UN~HEP A + HEP B (TWINRIX)~2|IPV~SANOFI PASTEUR~Z0421~UNK~UN~UN~POLIO VIRUS, INACT. (IPOL)~2|TD~SANOFI PASTEUR~AC52B024AA~UNK~UN~UN~TD ADSORBED (NO BRAND NAME)~2|YF~SANOFI PASTEUR~UE91211~UNK~UN~UN~YELLOW FEVER (YF-VAX)~2|FLUN3~MEDIMMUNE VACCINES, INC.~500485P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB100AA~UNK~UN~UN~HEP A + HEP B (TWINRIX)~3|IPV~SANOFI PASTEUR~Z0421~UNK~UN~UN~POLIO VIRUS, INACT. (IPOL)~3|TD~GLAXOSMITHKLINE BIOLOGICALS~AC52B024AA~UNK~UN~UN~TD ADSORBED (DITANRIX)~3|YF~SANOFI PASTEUR~UE912AA~UNK~UN~UN~YELLOW FEVER (YF-VAX)~3	USA	Hospitalisation	Influenza
0274357	07/22/2008	MN	44.0	44		F	11/10/2006	Passing out 20 minutes after shot, elevated blood pressure for months, dizzy for 7 months or more, stool/bladder trouble/difficulty breathing/walking, put on anxiety drug 7 months. Saw Dr. sleep eye immediately after.  07/24/2008 MR received for multiple ER visits date 11/10/2007, 11/13/2007,  11/20/2007, 11/28/2007. Seen 11/10/2007 with c/o feeling weak and lightheaded which began 20 minutes after flu shot given at work. PE WNL. Assessment:  Malaise and Fatigue.  Adverse Effect-minor, not allergic. Seen 11/13/07 with c/o dizziness and H/A. Migraine began yesterday. Assessment:  Allergic Reaction. Referred to allergist. Seen 11/20/07 with c/o dizzines and recent H/A which have worsened since Flu shot. Pt reports Carbon monoxide detector at home keeps going off.  PE (+) for flushing. Cap refill not blanching white. Assessment:  Dizziness and Giddiness. Seen 11/28/07 with same c/o.  Assessment:  Lightheadedness. ? Anxiety issues.				Y	Y				Y	11/10/2006	11/10/2006	0	Labs and diagnostics:  Carboxyhemoglobin 1.3. Venous blood gases c/w hyperventilation. CXR WNL. BPs 104/72-140/86.	OTH	OTH		None	Allergic to Thimerosol in contact lens solution/Aleve.  PMH:Migraines.  Pneumothorax.  Allergies:  Codeine, Wellbutrin, Aleve			1						2	Bladder disorder; Blood pressure increased; Dizziness; Dyspnoea; Gait disturbance; Headache; Intestinal functional disorder; Loss of consciousness	FLU3~SANOFI PASTEUR~U12212AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0319977	07/22/2008	NH	14.0	14		F	06/04/2008	10/29/07 - Diagnosed with cystitis, started on Bactrim. 10/31/07 symptoms resolved, afebrile, administered HPV and flu vaccine.  11/6/07 presented to ER with 2-3 days progressive back and abdominal pain, vomiting.  Diagnosed with pyelanephtitis.  Given IV fluids and antibiotics (Rocephid) and additional PO antibiotics (Augmentin).  Returned to ER 11/7/07 continued pain, ? constipation as cause.  Prescribed mag citrate.  Office follow up 11/9/07 - abdominal and back pain remained unexplained with normal exam, labs, work-up.  11/12/07 patient reported symptoms resolving.				Y					Y	10/31/2007	11/04/2007	4	10/29/07 - positive urine cx; 11/6/07 - normal CBC, BMP, and Lipase.  UA positive WBCs and bacteria.  11/7/07 - renal U.S., abdominal x-ray normal; Normal CBC, CMP.  Negative urine HCG.	PVT	PUB	Bactrim; pyridium prescribed 10/29/07.	None	1. 10/29/07 diagnosed with UTI, symptoms resolved on 10/31/07.  2. Mood disorders.			1						1	Abdominal pain; Back pain; Constipation; Culture urine positive; Full blood count normal; Lipase normal; Metabolic function test normal; Pain; Pregnancy test negative; Pyelonephritis; Ultrasound kidney normal; Vomiting; White blood cells urine positive; X-ray normal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~42507AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HPV4~MERCK & CO. INC.~10634~1~IM~RA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0319458	07/24/2008		66.0			F	07/21/2008	Initial report received on 09 July 2008 from a literature article. Verbatim from the report: A 66-year-old woman, presented to the hospital on 21 October 2007, after progressively worsening neurological complaints. The patient stated that she had onset of headaches a week or so before admission, soon associated with some numbness and tingling in her hands, and feet, and later associated with dysarthria and swallowing difficulties, prompting her to get further medical attention in the emergency room. The patient had no viral-type illnesses; however, a week or so before symptom onset, she had a flu shot as well as a PNEUMOVAX 23. The patient was evaluated by neurology with multiple tests. MRI and MRA scans demonstrated no significant abnormality that could have caused her symptoms. With the patient's history physical, and diagnostic testing done, she was diagnosed with Miller-Fisher variant of Guillain-Barre syndrome. The patient was treated with intravenous immunoglobulin. At this point, the patient noted stability in her course, no worsening, but had not noted much improvement either. Overall, she felt somewhat weaker on the left versus the right, but noted significant difficulties with coordinating her movements. She also noted residual numbness and tingling involving her face, the inside of her mouth, in her lower extremities in a knee sock-type distribution and in a glove distribution in the upper limbs. She did admit to facial weakness with some dysarthria; however, noted improvement in her face and in her speaking. She was experiencing some intermittent bouts of pain. She had pain in her limbs, particularly her legs, described as a combination of burning pain, cramping, and irritating numbness and tingling. The patient was on GABAPENTIN. The patient also developed what she called spells, where she experienced an autonomic instability giving her a 3 to 10-minute period of dizziness, change in vision, headache, and hypotension. The patient was previously fully independent with activities of daily living as well as ambulation. She had no medical limitations. On physical examination, the patient had difficulty in her feet with digit identification as well with propiroception, which was absent at her toes. Light touch sensation was decreased beginning at about the mid thigh level and gradually worsening down to her toes. Upper extremity sensation was not as markedly decreased as in her feet, but there was decreased light touch sensation in bilateral hands as well as decreased vibratory sensation. Myoclonus was present bilaterally in both lower extremities. Rotational dystonia was also present in her ankles, more pronounced on her left side. Digit identification was intact in her hands. With manual muscle testing in general side had 4/5 strength in her limbs, with hand intrinsics being weaker, but she was able to give some minimal resistance with intrinsic testing. Reflexes were obtained at her ankles, 1+ at the knees, and 1+ in her upper extremities. Extraocular movements were intact. No nystagmus was noted. Mild facial weakness was noted bilaterally. Her speech was mildly dysarthric. There was significant ataxia with attempts at gross as well as fine motor movements, more pronounced in the lower extremities versus the upper extremities. The recovery status of the patient was not reported.					Y						10/14/2007		Not reported	UNK	UNK			The patient had no viral-type illnesses at the time of the vaccinations.		200802231	1						2	Asthenia; Ataxia; Blood product transfusion; Burning sensation; Coordination abnormal; Cranial nerve disorder; Dizziness; Dysarthria; Dysphagia; Dystonia; Facial paresis; Headache; Hypoaesthesia; Hypotension; Loss of proprioception; Miller Fisher syndrome; Myoclonus; Neurological symptom; Nuclear magnetic resonance imaging normal; Pain in extremity; Pallanaesthesia; Paraesthesia; Sensory loss; Visual disturbance; Ataxia; Dizziness; Dysarthria; Dysphagia; Dystonia; Facial paresis; Gait disturbance; Headache; Hypoaesthesia; Hypotension; Miller Fisher syndrome; Movement disorder; Muscle spasms; Myoclonus; Neurological symptom; Nuclear magnetic resonance imaging; Pain; Pain in extremity; Paraesthesia; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0320397	07/24/2008	KY	28.0	28		M	07/24/2008	Initially said it was Bells Palsy, then changed to Ramsey Hunt Syndrome.  Right side Facial paralysis, Inflammation of 5, 7, and 10th nerve, matallic taste in mouth.  Most of these have resolved to slight signs.  I still have hearing and vision loss, eyes and ears are sensitive to loud noise and bright lights, Trigeminal and occipital neuralgia, balance and coordination off, tingling, twitching, numbness and nerve pain and loss of feeling in right arm, shoulder feels like it is rotting the cells and tissue and joints, constant feeling like my head could explode, nausea, vertigo, dizzy, can barely hold my head upright, muscle spasms, acid reflux, high blood pressure, E.D., Depressed and constantly in 6-10 levels of pain now for almost 8 months.  Wind 9/29/08-records received-presented to clinic on 1/1/08- with C/O headache and pressure, facial drooping and numbness, decrease in hearing, blurry vision and slight weakness to right arm times 3 days. Exhibited slurred speech, unable to blink right eye. DX: Bell's Palsy.			Y	Y			Y	Y	N	12/19/2007	12/28/2007	9	MRI, MRA, CT Scans, EEG, EKG, 9/29/08-records received-CT scan normal.	MIL	MIL		N/A	N/A			1						1	Balance disorder; Coordination abnormal; Depression; Dizziness; Dysgeusia; Electrocardiogram; Electroencephalogram; Erectile dysfunction; Gastrooesophageal reflux disease; Headache; Herpes zoster oticus; Hyperacusis; Hypertension; Hypoaesthesia; Muscle spasms; Muscle twitching; Nausea; Neuralgia; Nuclear magnetic resonance imaging; Pain; Paraesthesia; Photophobia; Trigeminal neuralgia; Vertigo	ANTH~UNKNOWN MANUFACTURER~~2~~~ANTHRAX (NO BRAND NAME)~1|FLU3~PFIZER\WYETH~~3~~~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0320422	07/24/2008	NC	35.0	35		M	07/24/2008	Developed swelling, redness, pain at injection site of last 2 anthrax vaccines he received.										10/11/2007	10/12/2007	1		UNK	UNK						1						1	Injection site erythema; Injection site pain; Injection site swelling	ANTH~MICHIGAN DEPT PUB HLTH~~UNK~SC~~ANTHRAX (NO BRAND NAME)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0299093	07/25/2008	ND	0.5	0	.5	M	07/25/2008	Next day after receiving several vaccines patient deveoped irritability and fever and weakness of left side of the body. Within few days he was diagnosed with right sided stroke (middle cerebral artery).  He required prolonged hospital stay including ICU care including mechanical ventilation.  Patients condition improved but has weakness on left side. 1/26/2010 Patient improved but has residual left Hemiparesis and Speech disorder.			Y	Y	Y	18		Y	N	11/21/2007	11/22/2007	1	MRI shows stroke in MCA distribution.  MRA - right internal carotid is smaller (congenital variant?)  Numerous lab tests did not reveal clear cause.	UNK	UNK		No	Was in car accident two months before vaccination - no significant injury.			1						2	Cerebrovascular accident; Hemiparesis; Irritability; Laboratory test; Mechanical ventilation; Nuclear magnetic resonance imaging abnormal; Nuclear magnetic resonance imaging brain abnormal; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B125AB~UNK~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~2|FLU3~SANOFI PASTEUR~UT247DA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|PNC~PFIZER\WYETH~B54013D~UNK~IM~LL~PNEUMO (PREVNAR)~2|RV5~MERCK & CO. INC.~0770U~UNK~PO~MO~ROTAVIRUS (ROTATEQ)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0320446	07/25/2008	AZ	16.0	16		F	07/22/2008	GARDASIL 9-12-07, 11-15-07 Patient reports fainting day after receiving GARDASIL. (reported 07/22/2008).									Y	11/15/2007	11/16/2007	1	Seek medical attention if symptoms return	PUB	PUB		None	Penicillin allergy; knee burn			1						1	Syncope	FLU3~SANOFI PASTEUR~U2367AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB207AA~1~~RA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~0929U~2~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0320633	07/28/2008	MD	40.0	40		M	07/28/2008	Patient had 'cold' for 1.5 weeks, then right ear and head pain for which he was given Septra.  Approximately 2 days later, he awakened with partial right facial weakness (on 10 Nov 2007).  Also had right hyperacusis, tinnitus and decreased hearing on right.  No taste changes, but had drooling from right side of mouth.  No extremity weakness/numbness, although he had the sensation of pain from right face down right anterior chest and right shoulder.  He reported to an ER that evening, where blood work and a head CT were normal.  He was given a prednisone taper dose over 10 days and Vicodin for pain.  Approximately 3 days later, he developed right ear pustules, erythema and swelling, and was given Valtrex for 7 days.  His symptoms improved until 1.5 weeks later when the pain again increased, and he was given a second prednisone taper, this time for 5 days.  He again improved until approximately 1 week ago, when his right facial pain worsened and he was given a combination of Tylenol #3 and Motrin 800mg tid.  Currently, he estimates his pain level to be 50% improved compared to when it was at its worse.  His facial weakness is mildly better, as he can now more fully close his right eye.  He used a patch for 4 days initially, and continues to use eye drops during the day.  He also initially had mild veritgo, which now only occurs rarely, for short durations.  Later diagnosed as Ramsay-Hunt Syndrome. 9/18/08-records received-Office visit 11/13/07-Seen in ER for right sided Bells' palsy, symptoms began on 11/10/07. Dry cough and right ear pain for 5 days.  Office visit 12/7/07-symptoms improved and not returned including ear pain. Right ear pustules, erythem and swelling. 12/9/07- resolving sinusitis.				Y					N	11/09/2007	11/09/2007	0	13 Nov 2007 - Lyme disease Ab total screen: Borrelia burgdorferi Ab (Serum) negative; Angiotension converting enzyme (Serum) 9 (9-67); Thyrotropin (Serum) 1.306 mcIU/mL (0.350-5.500); ESR (Blood) 17 (M) mm/hr (0-15). 9/18/08-records received-CT scan normal. MRI auditory canals dehiscence at tegman tympani. MRI of brain abnormal signal right facial nerve consistent with neuritis.WBC 11.5. ESR 17.	MIL	MIL	Flonase; Allegra; Zoloft; Atorvastatin; Lisinopril; HCTZ	Recent URI	Seasonal allergies; HTN; Hypercholesterolemia 9/18/08-records received-PMH:allergic rhinitis, RAD vs asthma, HTN, hypercholesterolemia and depression.			1						1	Angiotensin converting enzyme; Auricular swelling; Blood test normal; Blood thyroid stimulating hormone; Borrelia burgdorferi serology negative; Computerised tomogram normal; Drooling; Ear pain; Erythema; Facial pain; Facial paresis; Headache; Herpes zoster oticus; Hyperacusis; Hypoacusis; Musculoskeletal pain; Nasopharyngitis; Non-cardiac chest pain; Pain; Rash pustular; Red blood cell sedimentation rate increased; Swelling; Tinnitus; Vertigo	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0320638	07/28/2008	PA	71.0	71		F	07/18/2008	2 hours after PNEUMOVAX developed sore, swollen, painful RUA.  Arm rash.  Temp 101.9.				Y						12/04/2007	12/04/2007	0		PVT	PVT						1						1	Oedema peripheral; Pain in extremity; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U2494AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0320671	07/28/2008	DC	38.0	38		M	07/28/2008	Local reaction within few days following anthrax vaccine (red, tender, swollen sub-q knot).				Y					Y	12/04/2007	12/05/2007	1	None	MIL	MIL	None	None	Left knee pain, PTSD			1						1	Erythema; Local reaction; Skin nodule; Swelling; Tenderness	ANTH~EMERGENT BIOSOLUTIONS~FAV158~UNK~SC~UN~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0320752	07/29/2008	MO	49.0	49		F	07/29/2008	Irregular bleeding, abnormal ultrasound, uterus enlarged, endometrial pelvic, abnormal multiple cysticareas, left ovary solid component, 3.5 cysts with septations: left ovariectomy, endocervic D & C, endometrium D & C, simple hyperplasior laparoscopy ovary evaluation, hyperoscopy evaluation of endometrium operation procedure.  Did tests, x-rays, electrocardiogram, hematology. 8/14/08-records received-8/14/08-records received for DOS 3/6/08-Same day surgery for C/O menometrorrhagia and uterine fibers. US sholwed left complex ovarian cyst and abnormal endometrial.Laprascopic adhesiolysis with left oophorectomy. Hysteroscopy with dilatation and curettage.			Y	Y	Y	1		Y	N	01/09/2008	01/28/2008	19	Hematology - Normal; Chemistry normal; Cardiogram normal; Lung X-ray normal; Coagulation - normal 8/14/08-records received- CA 125 normal. Pathology report three simple ovarian cysts. No atypia found in endometrium.	PUB	PVT	No medications	No short term illness on that date	Penicillin, Caffeine allergies, Pre-existing anxiety 2006.			1						1	Coagulation test normal; Electrocardiogram normal; Haematology test normal; Haemorrhage; Laboratory test normal; Laparoscopy; Menstruation irregular; Ovarian cyst; Ultrasound scan abnormal; Uterine dilation and curettage; Uterine enlargement; X-ray normal	FLU3~SANOFI PASTEUR~U2509~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHVB173AA~1~IM~RA~HEP A (HAVRIX)~1|PPV~MERCK & CO. INC.~U324~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0320904	07/31/2008	NJ	62.0	62		F	07/28/2008	Rash appears on neck and few days after shot, cream then visit to dermatologist when rash spreads to chest and eventually down to legs - no itching - two doses Prednisone cream - 6 biopsies (nothing conclusive) (not allergic to egg or chicken).  Small brown spot around area where shot administered. 1/26/2010 Death  8/18/2008 MR received from dermatology consult dated 12/18/07 and 01/02/2008 with DX:  Contact dermatitis, possible drug eruption/allergy.  Pt presented with rash which began 2 days s/p flu shot.  PE (+) for erythematous annular and confluent patches on thighs, waistband and chest.  Erythematous cribiform patches of edematous papules on nape of neck. 31x3mm band of light brown macule on R upper arm at flu shit injection site. Rashes improve with steroids. ROS also (+) for SOB, night sweats, foot swelling, constipation and diarrhea. F/U 1/2/08 with rash slowing resolving.  8/25/2008 MR received for several OVs beginning 12/27/07 with DX:  Contact Dermatitis.  Erythema Multiforme.  Allergic urticaria.  Unspecified adverse effect of unspecified drug.								Y	N	11/02/2007	11/05/2007	3	Biopsies (6) - Doctor visit to allergist.  Labs and Diagnostics:  Biopsy-likely drug reaction or bug bite-papular urticaria.	OTH	OTH	Flomax; Crestor; Centrum Silver; Calcium with D	None	High cholesterol; slight osteoporosis. PMH:  knee surgery, partial vulvectomy, conization, boils, genital warts, shoulder repalcement.			1						1	Biopsy; Injection site discolouration; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~2~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Disabling	Influenza
0321028	08/01/2008	WI	35.0	35		F	07/28/2008	Initial report received on 30 November 2007 from a health care professional. A 35-year-old female patient had received an intramuscular injection of ADACEL, lot number C2842AA, on 24 October 2007. Site of administration was not provided. The patient's last menstrual period was 20 October 2007. It was determined that the patient was pregnant. The estimated date of delivery was uncertain at the time of this report. Current medications included Nasonex. Per the reporter, the patient did not experience any adverse event. Follow-up information was received from the health professional on 16 June 2008. In addition to ADACEL, the patient also received an intramuscular injection of FLUZONE (lot number U2437AA) on 24 October 2007. The reporter did not consider the patient to be pregnant at the time of vaccination, as the date of last menstrual was 20 October 2007 and the patient received the vaccines on 24 October 2007. No additional information was provided. Follow-up information received on 25 July 2008 from the original reporter who is a health care professional. The ADACEL and FLUZONE SV 2007-2008 administered to the patient on 24 October 2007 were the first, and fifth doses the patient had received of these vaccines respectively. The patient's estimated date of delivery was on July 28, 2008; however the patient experienced a spontaneous abortion (also reported as miscarriage) approximately two months post-vaccination of one single fetus beginning in December 2007 that was confirmed on 02 January 2008. The patient was less than 20 weeks gestation. The reason for the spontaneous abortion was not known, but the patient's Beta HCG's levels had been decreasing in value that indicated a miscarriage. The patient had not received any prior treatments for infertility, and had not experienced any illnesses during the pregnancy. No prenatal testing had been completed. At the time of this report, it was unknown if the patient had recovered. After review of this new information, this case was upgraded to serious.				Y					U	10/24/2007	12/01/2007	38	None	PVT	UNK	NASONEX		The patient had one prior pregnancy that resulted in a full term, normal outcome.  Past medical history was denied.  From new information received on 25 July 2008, the patient experienced no illnesses during her current pregnancy.  The patient had no other vaccinations within four weeks of 24 October 2007.		200704125	1						1	Abortion spontaneous; Drug exposure during pregnancy	FLU3~SANOFI PASTEUR~U2437AA~5~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2842AA~1~IM~UN~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0321122	08/03/2008	NC	47.0	47		F	08/03/2008	MBR STATES THAT HE HAS LOST ALL SENSE OF TASTE AND SMELL									U	11/17/2007	11/18/2007	1	MBR HAS BEEN REFERRED TO CIVILIAN HEALTH CARE PROVIDER FOR DIAGONOSIS	MIL	MIL		NONE	NONE	LOSS OF SENSE OF TASTE AND SMELL~Influenza (Seasonal) (FluMist)~1~47.90~In Patient		1						1	Ageusia; Anosmia	FLUN3~MEDIMMUNE VACCINES, INC.~600496P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0293431	08/06/2008	CO	76.0	76		F	07/30/2008	Initial and follow up information has been received from a pharmacist concerning a 76 year old female patient with a history of cardiac disorder and no known allergies who on 01-OCT-2007 at 16:00, was vaccinated IM into the left deltoid with a first dose of PNEUMOVAX 23 (Lot# 65855/0964U). Concomitant therapy given into the right deltoid included a dose of FLUZONE (Lot# U2488AA). On 02-OCT-2007, twenty four hours after vaccination, the patient developed erythema and heat that spread to the elbow and up through the chest and armpit. it was also painful to move her extremity. The patient was treated with TYLENOL and ice to the left side of her arm and chest. The patient was to be seen at the pharmacy on 03-OCT-2007 for follow up. No laboratory diagnostic studies were performed. At the time of this repot, the patient recovered. No product quality complaint was involved.  Additional information is not expected.				Y					Y	10/01/2007	10/02/2007	1	None	OTH	PVT			Cardiac disorder		WAES0710USA00837	1						2	Erythema; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~U2488AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0964U~1~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0294128	08/06/2008	OH	66.0	66		F	07/30/2008	Information has been received from a registered nurse concerning a 66 year old female with allergies to quinolones and BACTRIM who on 15-OCT-2007 at 11:00 am was vaccinated intramuscularly into the left deltoid with a second dose of PNEUMOVAX (Lot #657525/0554U).  Concomitant vaccination on the same day included an intramuscular injection into the left deltoid of a yearly dose of FLUZONE (influenza virus whole virion 3v vaccine inactivated) (Lot #U2465AA).  On 15-OCT-2007 at 6:00 pm the patient's left arm swelled from the shoulder to the elbow, became red and hot with no itching.  The patient's face and chest also became red and hot.  There was no laboratory or diagnostic tests performed.  On 16-OCT-2007, the patient was seen in the physician's office.  Subsequently, the patient recovered.  Additional information has been requested.				Y					Y	10/15/2007	10/15/2007	0	Unknown	PUB	PUB	Unknown	Hypersensitivity; Sulfonamide allergy			WAES0710USA04694	1						2	Erythema; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U2465AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0554U~2~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0294129	08/06/2008	OH	71.0	71		M	07/30/2008	Information has been received from a registered nurse concerning a 71 year old male with gout who on 15-OCT-2007 at 11:00 am was vaccinated intramuscularly into the left deltoid with a second dose of PNEUMOVAX 23 (Lot #657525/0554U). Concomitant vaccination on the same day included an intramuscular injection into the left deltoid of a yearly dose of FLUZONE ( Lot #U2465AA). On 15-OCT-2007 at 3:00 pm the patient experienced an increase in gout symptoms: pain, tenderness and warmth in the feet and knees. There was no laboratory or diagnostic tests performed. Subsequently, the patient recovered. Additional information has been requested.									Y	10/15/2007	10/15/2007	0	Unknown	PUB	PUB	Unknown	Gout			WAES0710USA04696	1						2	Condition aggravated; Gout; Joint warmth; Pain; Tenderness	FLU3~SANOFI PASTEUR~U2465AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0554U~2~IM~LA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0294610	08/06/2008	CO	48.0	48		F	07/30/2008	Initial and follow-up information has been received from a registered nurse concerning a 48 year old female receptionist (previously reported as 4 or 5 patients) with no illness at the time of being vaccinated and no history of allergies or medical conditions.  On an unspecified date, greater than 5 years ago, the patient received a first dose of PNEUMOVAX.  On 18-OCT-2007, th patient was vaccinated with a second dose of PNEUMOVAX (lot # 655500/1005F) IM in the left arm at 6:30 AM.  Also on 18-OCT-2007, the patient was vaccinated with FLUVIRIN (Novartis) (lot # 80959) IM in the left arm at 06:30 AM.  On 19-OCT-2007, the patient complained of a fever of 102 degrees Fahrenheit, swelling and pain at the injection site.  The patient described that her bone felt detached from her skin and she felt extremely miserable (previously reported as cellulitis at the injection site).  She continued to feel better daily and on 22-OCT-2007 she felt normal (recovered).  No additional information is expected.									Y	10/18/2007	10/19/2007	1	Temperature measurement, 10/19/07, 102F	OTH	PVT			Unknown		WAES0710USA05008	1						2	Body temperature increased; Feeling abnormal; Injection site cellulitis; Injection site pain; Injection site swelling; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80959~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~1005F~2~IM~LA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0294816	08/06/2008	MI	70.0			F	07/30/2008	Information has been received from a 70 year old female who in approximately 2002 (at age 65, 5 years ago) was vaccinated with a first dose of PNEUMOVAX 23 without any adverse events. On 25-OCT-2007, the patient was vaccinated with a second dose of PNEUMOVAX 23 (lot # 655766/0038U) 0.5 ml injection in the right arm. Also given on the same date on 25-OCT-2007 included influenza virus vaccine (unspecified) in the left arm. Concomitant therapy included PREMARIN CREAM. On 25-OCT-2007, the patient experienced bruising, pain, and welts in the area where she received the PNEUMOVAX 23. She sought the medical attention of her physician who prescribed prednisone and the events dissappated. The patient did not have any adverse events in the arm where the influenza virus vaccine vaccine was given. In October 2007, the patient recovered. Follow-up information was received from the physician. Since being vaccinated on 25-OCT-2007, the patient developed a very warm erythematous rash with mild itching. On 27-OCT-2007, the patient was evaluated by the physician. Her temperature was 98.2 and blood pressure was 186/58. The patient was in no distress. The left arm injection site was clean and intact. The right arm had an injection site with a small ecchymosis surrounding it of less than 1 cm in size. Beyond that, there was some urticaria-appearing rash of about 10 x 6 cm in size. It did not have a cellulitic appearance. Impression was a reaction to PNEUMOVAX 23. Flan was to treat her with prednisone for 3 days to calm down the inflammation. She may use BENADRYL for any itching. The patient desired an allergy consultation to determine what causative agent was present in the vaccination and this was provided. The patient, later in the day, called the physician questioning the need for prednisone: it was agreed that she try the diphenhydramine and then start prednisone if no improvement or any worsening. The outcome of the urticaria appearing erythematous rash was not reported. No additional information is expected.				Y					Y	10/25/2007	10/25/2007	0	blood pressure, 10/27/07, 186/5; temperature measurement, 10/27/07, 98.2	OTH	OTH	PREMARIN		Unknown		WAES0711USA00355	1						2	Blood pressure increased; Injection site bruising; Injection site pain; Injection site reaction; Injection site urticaria; Rash erythematous; Rash pruritic; Skin warm; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0038U~2~UN~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0297636	08/06/2008	TX	51.0	51		M	07/30/2008	Initial and follow-up information has been received from a physician's office manager, pharmacist, and registered nurse concerning a 51 year old male teacher with seasonal allergies and asthma, who on 01-NOV-2007 at 08:00 was vaccinated IM in the right deltoid with a first dose of PNEUMOVAX 23 (lot #657149/1226U).  Concomitant vaccination included influenza virus vaccine (unspecified) administered in the left deltoid.  Other concomitant medications included PULMICORT, and albuterol.  There were no illnesses at the time of the vaccinations.  On 01-NOV-2007 within 15 minutes post injection the patient experienced chest tightness that lasted a few minutes.  The patient did not return to the clinic.  On 01-NOV-2007 at 19:00 the patient felt feverish, aching, and had chills until the fever broke in the night.  The patient experienced enlarged lymph nodes under the right arm that were swollen and tender, and arm pain.  The symptoms lasted 48 to 60 hours.  It was reported that no treatment was sought.  The patient visited the school district nurse.  The patient recovered on 04-NOV-2007.  A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the center and was released.  Additional information is not expected.									Y	11/01/2007	11/01/2007	0	Unknown	OTH	PVT	albuterol, PULMICORT	Seasonal allergy; Asthma			WAES0711USA02357	1						2	Axillary pain; Chest discomfort; Chills; Lymphadenopathy; Pain; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U2466AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1226U~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0297637	08/06/2008	TX	56.0	56		F	07/30/2008	Initial and follow-up information has been received from a physician's office manager, pharmacist, and a registered nurse concerning a 56 year old female teacher with frequent upper respiratory infections and nasal allergies, who on 01-NOV-2007 at 08:00 was vaccinated IM in the right deltoid with a first dose of PNEUMOVAX 23 (lot # 657145/1226U). Concomitant vaccination included influenza virus vaccine (unspecified) (Lot# U2466AA) administered in the left deltoid. There were no illness at the time of the vaccination. Within nine hours post injection on 01-NOV-2007 at 17:30 the patient experienced redness at the injection site, fever, aches, and joint pain. the patient's fever broke in the night. The patient developed swollen, palpable, and tender lymph nodes under her right arm for three days. Thirty six hours post vaccination it was noted that the patient developed a 2 reddened circular area near the armpit.  All the patient's symptoms resolved after four days. There was no treatment. The patient visited the school district nurse. The patient recovered on 05-NOV-2007. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.									Y	11/01/2007	11/01/2007	0	Unknown	OTH	PVT	(therapy unspecified)	Rhinitis allergic; upper respiratory tract infection			WAES0711USA02354	1						2	Arthralgia; Axillary pain; Erythema; Injection site erythema; Lymphadenopathy; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2466AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1226U~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0297638	08/06/2008	TX	54.0	54		F	07/30/2008	Initial and follow-up information has been received from a physician's office manager, pharmacist, and registered nurse concerning a 54 year old female information officer with a pacemaker, and a history of transposition of great vessels, and a heart blockage 26 years ago, who on 01-NOV-2007 at 08:00 was vaccinated IM in the right deltoid with a first dose of PNEUMOVAX (lot #657145/1226U).  Concomitant vaccination included FLUZONE (unspecified) (Lot# U2466A) administered IM in the left deltoid.  Other concomitant medications included LIPITOR, PREMARIN, SYNTHROID, and blood pressure medicine possible terazosin hydrochloride (therapy unspecified).  There were no illnesses at the time of the vaccinations.  On 01-NOV-2007 at 12:00 the patient experienced soreness at the injection site, decreased arm mobility, anxiety, chest tightness, black knuckles and black nails (like dirt or oil).  The patient visited the school district nurse.  The patient's black knuckles and nails lasted 96 hours (previously reported as resolved by 06-NOV-2007).  Five to six days post injection the patient experienced joint pain and fever.  The patient recovered on 09-NOV-2007.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the research center and was released.  Additional information is not expected.									Y	11/01/2007	11/01/2007	0	Unknown	OTH	PVT	[therapy unspecified]; LIPITOR; PREMARIN; SYNTHROID		Transposition of the great vessels; Atrioventricular block		WAES0711USA02355	1						2	Anxiety; Arthralgia; Chest discomfort; Injected limb mobility decreased; Injection site pain; Nail discolouration; Pyrexia; Skin discolouration	FLU3~SANOFI PASTEUR~U2466AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1226U~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0297644	08/06/2008	TX	36.0	36		M	07/30/2008	Information has been received from a physician's office manager pharmacist, and a registered nurse concerning a 36 year old white male bartender with nasal allergies, frequent upper respiratory infections, and a history of pneumonia two times in 2006, who on 25-OCT-2007 at 15:00 was vaccinated IM in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot #657145/1226U). Concomitant vaccination included influenza virus vaccine (unspecified). Other concomitant medication included OTC Allergy medications (therapy unspecified). There were no illnesses at the time of the vaccination. On 25-OCT-2007 at 19:00, the patient experienced pain and decreased mobility of the left arm and shoulder. By the next morning a raised red line developed from the injection site into the left armpit and was very tender. It was reported that all symptoms were gone by the fourth day post injection. There was no treatment. The patient visited the school district nurse. The patient recovered on 29-OCT-2007. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No additional information is expected.									Y	10/25/2007	10/25/2007	0	Unknown	OTH	PVT	(therapy unspecified)	Rhinitis allergic; Upper respiratory tract infection	Pneumonia		WAES0711USA00685	1						2	Injected limb mobility decreased; Injection site erythema; Injection site streaking; Injection site swelling; Pain in extremity; Tenderness	FLU3~SANOFI PASTEUR~U2466AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1226U~1~IM~LA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0298783	08/06/2008	OR	64.0	64		F	07/30/2008	Information has been received from a registered nurse concerning a 64 year old female with penicillin, erythromycin, and KEFLEX allergies and no illness at the time of vaccination, who on 03-DEC-2007 was vaccinated with PNEUMOVAX 23 (lot # 658200/0804U) intramuscularly in the right deltoid. Concomitant therapy included influenza virus vaccine (unspecified) (Lot #AFLLA061AA) intramuscularly in the left deltoid on the same day. On 03-DEC-2007, the patient developed a silver dollar size induration, right arm was erythematous and painful the same day. The patient had a fever of 102 degrees Fahrenheit. The patient sought medical attention (date not reported) and was treated with SEPTRA DS twice a day for ten days. The patient recovered on an unspecified date. No additional information is expected.				Y					Y	12/03/2007	12/03/2007	0	body temp, 102 Faren	PVT	PVT		Penicillin allergy; Allergic reaction to antibiotics			WAES0802USA03088	1						2	Body temperature increased; Erythema; Induration; Pain in extremity; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA061AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~2|PPV~MERCK & CO. INC.~0804U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0301972	08/06/2008	TN	71.0	71		F	07/30/2008	Information has been received from a Licensed Practical Nurse concerning a 71 year old female patient with low back pain, depression, restless legs syndrome, colonic polyp and gastrooesophageal reflux disease who in 2001 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. On 03-DEC-2007, she was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine IM 0.5 mL lot #659150/1384U. Concomitant therapy included NEXIUM, EVISTA, NEURONTIN, CYMBALTA, aspirin, TRAMADOLOR and RELAFEN. The reporter reported that the patient returned to the doctor's office on 05-DEC-2007, 06-DEC-2007 and 07-DEC-2007 since she developed redness and swelling in the left arm. An ultrasound of the left arm was completed and the result was negative. The nurse reported that the patient returned to the office for another issue on 26-DEC-2007 and that time the swelling and redness to the left arm had recovered. No additional information was available. Additional information has been requested.				Y					Y	12/03/2007	12/05/2007	2	brachial artery - ultra sound of left arm was Negative	OTH	OTH	aspirin; CYMBALTA; NEXIUM; NEURONTIN; RELAFEN	Low back pain; Depression; Restless legs syndrome; Colonic polyp; Gastrooesophageal reflux disease			WAES0801USA03500	1						2	Contusion; Erythema; Joint swelling; Nuclear magnetic resonance imaging; Oedema peripheral; Pain in extremity; Pruritus; X-ray; Erythema; Oedema peripheral; Ultrasound scan normal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA055AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1384U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~1384U~2~IM~~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0321413	08/06/2008	MT	59.0	59		F	08/04/2008	A 59-year-old female patient had received an injection (route/site and lot number not reported) of FLUZONE SV 2007-2008, and on the day of vaccination, she complained of pain in her shoulder that persisted for approximately four months.  She was diagnosed approximately four months later with a torn rotator cuff which she had surgically corrected.  Past medical history included osteoarthritis and menopausal symptoms.  No further information was provided.				Y						10/23/2007	10/23/2007	0		UNK	UNK			The patient had not been ill at the time of vaccination and had a past history of hyperlipidemia, menopausal symptoms, dizziness, ? osteoarthritis and breast cancer.		200802440	1						1	Musculoskeletal pain; Rotator cuff syndrome; Shoulder operation; Musculoskeletal pain; Rotator cuff syndrome; Surgery	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0321415	08/06/2008	TX				F	08/01/2008	Initial report was received on 28 July 2008 from another manufacturer who received the report from a health care professional.  A female patient (age and date of birth not reported) had received an Influenza vaccination in 1986 and developed the flu.  She also received a Tetanus vaccination in 1986 and developed lock jaw and drooling.  The event onset dates were reported as 1986.  The vaccine names, manufacturers, lot numbers, routes and sites of administration were not reported.  The patient's recovery status was not reported.				Y										UNK	UNK					200802445	1						1	Drooling; Influenza; Trismus	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~UN~UN~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0321589	08/06/2008	TX	46.0	46		F	07/30/2008	Initial and follow-up information has been received from an office manager concerning a 46 year old female with a history of breast cancer and an allergy to VICODIN, who on 20-SEP-2007 at 14:06 was vaccinated SC in the right arm with a 0.5 ml first dose of PNEUMOVAX 23 (lot #657525/0554U). Concomitant vaccinations included influenza virus vaccine (unspecified) (Lot# 79897) administered intramuscularly in the right deltoid. There were no illnesses at the time of the vaccination. On 21-SEP-2007 the patient developed cellulitis at the injection site. On 21-SEP-2007 the patient called and was seen in the physician's office. The patient was treated with KEFLEX. No laboratory diagnostics were performed. The patient recovered on an unspecified date. The office manager is requesting a lot check. A standard and enhanced lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the government and was released. The physician considered the cellulitis at the injection site to be an other important medical event. Additional information is not expected.				Y					Y	09/20/2007	09/20/2007	0	None	PVT	PVT			Breast cancer; Drug hypersensitivity		WAES0709USA04014	1						1	Incorrect route of drug administration; Injection site cellulitis; Underdose	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79897~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0554U~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0321613	08/06/2008	OH	62.0			M	07/30/2008	Information has been received from a 62 year old male registered nurse (concerning himself), with hypertension, drug hypersensitivity to refecoxib (MSD), a sulfonamide allergy, and a history of angioplasty, who in approximately 1997 (about 10 years ago), was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included influenza virus vaccine (manufacturer unspecified) and unspecified therapy for hypertension. In approximately 1997, he reported having a violent reaction to the vaccination, described as nausea, vomiting, threatening cramps in the stomach, and his whole body felt like going down the tubes. He reported the symptoms were severe enough that he considered calling 911, though he did not actually do so, nor did he seek any other medical attention. At the time of this report, the patient confirmed he had recovered, though the duration of the events and date of recovery was not specified. The patient had a history of cardiovascular disorder while on prior therapy with rofecoxib (MSD, WAES 0706USA02510). Additional information has been requested.									Y				None	OTH	OTH	(therapy unspecified)	Hypertension; drug hypersensitivity; Sulfonamide allergy	Angioplasty		WAES0706USA06342	1						1	Abdominal pain; General physical health deterioration; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0322105	08/06/2008	NY	74.0	74		F	07/30/2008	Information has been received from a licensed practical nurse, concerning a 74 year old female patient, who had been vaccinated 10 years prior with a dose of PNEUMOVAX, and on 21-SEP-2007 was vaccinated IM in the left arm with a second dose, 0.5ml, of PNEUMOVAX (lot #657525/0554U).  Concomitant therapy at the visit, included an IM vaccination in the left arm of FLUZONE.  The nurse stated that following the vaccination with PNEUMOVAX, the patient developed adverse symptoms described as immediate redness, swelling and soreness at the injection site, as well as a headache.  At the time of this report, the patient had not recovered.  This is one of two reports received from the same source (WAES #0709USA03759) following vaccination with PNEUMOVAX (lot #657525/0554U).  The nurse requested a lot check.  The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory.  The lot complies with the standards of the research center and was released.  Additional information has been requested.				Y					N	09/21/2007	09/21/2007	0	Unknown	OTH	OTH			Unknown		WAES0709USA03696	1						1	Headache; Immediate post-injection reaction; Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0554U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0322113	08/06/2008	NY	60.0	60		M	07/30/2008	Information has been received from a licensed practical nurse, concerning a 60 year old male patient, who on 19-SEP-2007 was vaccinated IM in the left arm with a dose, 0.5 ml, of PNEUMOVAX 23 (lot # 657525/0554U). Concomitant vaccine therapy at the visit included a dose in the left arm of FLUZONE. The following day, 20-SEP-2007, the patient called the office with symptoms of cellulitis, including redness and soreness at the injection site, and chills. Treatment with DURICEF was prescribed. The patient had a return visit scheduled to the physician on 22-SEP-2007 (future date). At the time of this report, the patient had not recovered. This is one of two reports received from the same source (WAES #0709USA03696) following vaccination with PNEUMOMAX 23 (lot #657585/0554U). The nurse a lot check. The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory. The lot complies with the standards of Center for Biologics Evaluation and Research, and was released. Additional information has been requested.				Y					N	09/19/2007	09/20/2007	1	None	OTH	OTH			None		WAES0709USA03759	1						1	Cellulitis; Chills; Injection site erythema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0554U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0322345	08/06/2008	NJ	72.0			F	07/30/2008	Information has been received from a certified medical assistant (CMA) concerning a 72 year old female with an allergy to penicillin and VISTARIL who on approximately 11-OCT-2007 was vaccinated SC in the left arm with a 0.5 mL dose of PNEUMOVAX 23 (lot #656233/0200U) and a dose of  influenza virus vaccine (site unspecified). It was reported that the patient was previously vaccinated with a dose of PNEUMOVAX 23 in November 1996 and may have had an earlier prior vaccination. On 11-OCT-2007, the patient developed swelling and redness at the injection site. The patient treated the injection site with cool compresses and took BENADRYL. On 12-OCT-2007, the patient was seen in the physician's office. The injection site reaction was described as an indurated, erythematous swollen reaction at the injection site. The patient was prescribed therapy with MEDROL DOSEPAK and Z-PAK. As of 16-OCT-2007, the injection site swelling and redness were going down. The patient was reported as recovering. A concern regarding the lot was reported. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the government and was released. The medical assistant reported another patient who developed an adverse experience after vaccination with PNEUMOVAX 23 (lot #656233/0200U) (WAES#0710USA03557). Additional information has been requested.				Y					N	10/11/2007	10/11/2007	0	None	OTH	OTH		Penicillin allergy; Drug hypersensitivity			WAES0710USA03567	1						1	Injection site erythema; Injection site induration; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~0200U~UNK~SC~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0322350	08/06/2008	TX	64.0	64		F	07/30/2008	Information has been received from a licensed visiting nurse concerning a 64 year old female with no medical history and a sulfonamide allergy, who on 04-OCT-2007 was vaccinated intramuscularly with a 0.5mL first dose of PNEUMOVAX 23 (Lot# 658555/0964U). Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient developed an injection site reaction with pain, swelling, and inflammation. The inflammation spread from the deltoid down to the elbow. The patient called the office. No laboratory diagnostics were performed. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. This is one of three cases from the same source. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the government and was released. Additional information has been requested.				Y					U	10/04/2007			None	OTH	OTH		Sulfonamide allergy			WAES0710USA03859	1						1	Injection site inflammation; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0964U~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0322351	08/06/2008					F	07/30/2008	Information has been received from a registered nurse, concerning a female patient (age not specified), who on 15-OCT-2007 was vaccinated IM with a dose of PNEUMOVAX 23 (lot # not provided). Concomitant vaccine therapy included influenza virus vaccine (manufacturer unspecified). On 15-OCT-2007, following the vaccination the patient developed an injection site reaction of redness and swelling. The nurse added that the patient had also received a dose of PNEUMOVAX 23 last year. Additional information has been requested.				Y					U	10/15/2007	10/15/2007	0	Unknown	OTH	OTH			Unknown		WAES0710USA03891	1						1	Injection site erythema; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0322353	08/06/2008	NM	48.0	48		M	07/30/2008	Information has been received from a physician and a consumer concerning her 48 year old husband with no medical history and an allergy to penicillin, who on 17-OCT-2007 at 09:35 in the am, was vaccinated into the left arm with a first dose of PNEUMOVAX 23. Concomitant medication included a dose of influenza virus vaccine (unspecified) also administered into the left arm. On 18-OCT-2007, the patient experienced a high fever, achy bones, and loss of appetite. The patient sought unspecified medical attention. No laboratory diagnostics studies were performed. Subsequently, the patient recovered. No product quality complaint was involved. Additional information is not expected.				Y					Y	10/17/2007	10/18/2007	1	Unknown	PVT	PVT		Penicillin allergy			WAES0710USA03983	1						1	Anorexia; Bone pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~AFLLA036AA~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0322364	08/06/2008	WA	39.0	39		F	07/30/2008	Initial and follow-up information has been received from a pharmacist concerning a 39 (also reported as 35) year old female patient, who on 10-OCT-2007 (also reported as 12-OCT-2007), was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (Lot# 657040/0859U). Concomitant therapy given in the same deltoid, about 2 to 3 inches from the first site, included a dose of influenza virus split virion 3v vaccine inactivated (Lot# U2453AA), administered intramuscularly. There were no illness at the time of the vaccinations. On 12-OCT-2007, the patient developed swelling up to 4 times the baseline at the injection site within 24 hours from the time of vaccination. It was reported that the patient felt lethargic and like she was about to die. The patient went to the hospital and was diagnosed with cellulitis at the site of the PNEUMOVAX 23, which spread to the rest of her body. The emergency room doctor stated that the cellulitis was due to the vaccination with PNEUMOVAX 23. She was put on Cephalexin and sent home. On 14-OCT-2007, the patient was reported to be feeling much better. On 15-OCT-2007, it was reported that the patient was going to see a physician at a Hospital. The reporter is requesting a lot check for PNEUMOVAX 23 (Lot# 657040/0859U). A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.				Y					N	10/10/2007	10/12/2007	2	Unknown	OTH	PVT			Unknown		WAES0710USA03035	1						1	Injection site cellulitis; Injection site swelling; Lethargy	FLU3~SANOFI PASTEUR~U2453AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0859U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0322372	08/06/2008	FL	58.0	58		F	07/30/2008	Information has been received from a medical office manager concerning a 58 year old female with type 2 diabetes mellitus, hypothyroidism, goitre, alopecia, hypertension, allergy to aspirin and penicillin allergy who on 12-OCT-2007 was vaccinated in the right arm with the first dose of PNEUMOVAX 23 (0.5 ml) (lot # 655766/0038U).  Concomitant vaccination included influenza virus vaccine (unspecified) in the left arm.  On 13-OCT-2007 the patient developed swelling underneath her armpit and redness on the injection site on the right arm.  It was reported that the patient did not have any reaction on the left arm where the influenza virus vaccine (unspecified) was administered.  Unspecified medical attention was sought.  At the time of this report, the patient was recovering.  Additional information has been requested.				Y					N	10/12/2007	10/13/2007	1	None	OTH	OTH		Type 2 diabetes mellitus; Hypothyroidism; Goitre; Alopecia; Hypertension; Drug hypersensitivity; Penicillin allergy			WAES0710USA03203	1						1	Injection site erythema; Local swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0038U~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0322374	08/06/2008	AL	69.0	69		F	07/30/2008	Initial and follow up information has been received from a pharmacist concerning a 67 year old female patient who on 13-OCT-2007 (previously reported as 12-OCT-2007) was vaccinated IM into right deltoid muscle with the first dose of PNEUMOVAX 23 (lot #658075/0962U).  Concomitant therapy included a dose, IM in the left shoulder, of FLUZONE (lot #U2493AA).  There was no illness at the time of the vaccination.  On 14-OCT-2007 (previously reported as 13-OCT-2007), the patient came into the pharmacy with a red, painful and swollen area on the inside surface of the right arm near the elbow, remote from the injection site.  Cool compresses and TYLENOL were recommended.  The symptoms lasted for several days after the vaccination.  Additional information is not expected.				Y					Y	10/13/2007	10/14/2007	1	Unknown	OTH	PVT			Unknown		WAES0710USA03325	1						1	Erythema; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2493AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0962U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0322380	08/06/2008					F	07/30/2008	Information has been received from a registered nurse, concerning a female patient (age not specified), who on 15-OCT-2007 was vaccinated IM with a dose of PNEUMOVAX 23 (lot # not provided).  Concomitant vaccine therapy included influenza virus vaccine (manufacturer unspecified).  On 15-OCT-2007, following the vaccination the patient developed cellulitis located 4 1/2 inches below the injection site.  At the time of this report, the outcome of the event was unknown.  Additional information has been requested.				Y					U	10/15/2007	10/15/2007	0	Unknown	OTH	OTH			Unknown		WAES0710USA03403	1						1	Cellulitis	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0322509	08/06/2008	CT				F	07/30/2008	Information has been received from a female medical office manager who on 22-OCT-2007 was vaccinated with a normal single dose of PNEUMOVAX 23.  Concomitant vaccination on 22-OCT-2007 included influenza virus vaccine (unspecified) in the same arm.  On 22-OCT-2007, right after vaccination, the patient developed red, swelling in a three inch diameter around the injection site.  It was reported that the rash became raised and hard and hot to touch.  The physician at the office administered the vaccine.  Unspecified medical attention was sought.  At the time of this report, the patient had not recovered.  Additional information has been requested.				Y					N	10/22/2007	10/22/2007	0	None	OTH	OTH			Unknown		WAES0710USA05051	1						1	Immediate post-injection reaction; Injection site erythema; Injection site rash; Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0322532	08/06/2008	PA	75.0	75		F	07/30/2008	Information has been received from a health care care worker concerning a 75 year old female with no pertinent medical history who in 1999 was vaccinated with a dose of PNEUMOVAX 23. On 18-OCT-2007 the patient was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (Lot #658075/0962U). Concomitant vaccination on the same day included a influenza virus vaccine (unspecified). On 18-OCT-2007 during the day the patient developed fever and chills, in the evening the patient developed pain at the injection site. the patient called the office. Subsequently the symptoms lasted for 24 hours and resolved on 19-OCT-2007. Additional information has been requested.				Y					Y	10/18/2007	10/18/2007	0	None	MIL	OTH			None		WAES0710USA04795	1						1	Chills; Injection site pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0962U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0322536	08/06/2008	AR	73.0	73		F	07/03/2008	Information has been received from a licensed practical nurse concerning a 73 year old female patient who on 26-OCT-2007, was vaccinated IM into the right deltoid with a 0.5ml dose of PNEUMOVAX 23 (Lot# 655500/1005F). Concomitant therapy included a dose of FLUVIRIN (Lot# 80062) given IM into the left deltoid. After receiving the vaccine, the patient experienced pain in her left upper arm. It was reported that her pain was 10 on a pain scale with 10 being the most pain and the least amount of pain. Unspecified medical attention was sought. On 01-NOV-2007, the patient recovered. It was also reported that the physician advised when the injection was given a nerve may have been damaged. No product quality complaint was involved. Additional information is not expected.				Y					Y	10/26/2007	10/26/2007	0	Unknown	PVT	PVT			Unknown		WAES0710USA06576	1						1	Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80062~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1005F~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0322662	08/06/2008		53.0	53		F	07/30/2008	Information has been received from a registered nurse concerning a 53 year old female with hypertension, diabetes mellitus insulin-dependent and goitre who on 03-OCT-2007 was vaccinated intramuscularly in the left deltoid with a 0.5 mL dose of PNEUMOVAX 23 (lot # 655765/0061U).  Concomitant therapy included unspecified influenza virus vaccine (Novartis) on 03-OCT-2007 administered in the right arm, aspirin, lorazepam, losartan potassium (MSD), SYNTHROID, diclofenac Na, insulin aspart, NOVOLOG MIX 70/30 and LIPITOR.  On 03-OCT-2007 the patient experienced severe localized reaction after vaccination with PNEUMOVAX 23.  The site was described as large, red and swollen.  Symptoms were located from the injection site down to the inner aspect of the elbow of the left arm.  The patient was instructed to contact the doctor's office with any symptoms.  On 05-OCT-2007, the patient reported that symptoms improved, using a warm compress.  The site was described as red.  On 08-OCT-2007, the symptoms resolved.  No laboratory diagnostic tests were performed.  There was no product quality complaint.  Additional information has been requested.				Y					Y	10/03/2007	10/03/2007	0	None	OTH	OTH	aspirin, LIPITOR, diclofenac sodium, NOVOLOG MIX 70/30, SYNTHROID, lorazepam, COZAAR	Hypertension; Diabetes mellitus insulin-dependent; Goitre			WAES0710USA02384	1						1	Injection site erythema; Injection site swelling; Local reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0061U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0322671	08/06/2008	AR	67.0	67		M	07/30/2008	Information has been received from a nurse concerning a 57 year old male with one kidney, renal insufficiency, hypertension, hyperlipidaemia, chronic ployps and drug hypersensitivity to sulfa and SUDAFED who on 24-OCT-2007 was vaccinated intramuscularly in the left arm with his first 0.5ml dose PNEUMOVAX 23 (lot# 657526/0555U). On 24-Oct-2007, the patient was concomitantly vaccinated with influenza virus vaccine (manufacturer unknown) in the right arm. Concomitant therapy included LIPITOR, LOTENSIN, hydrochlorothiazide (manufacturer unknown), aspirin and oxycodone. On the evening of 24-Oct-2007, post vaccination, the patient stated that his arm hurt at bedtime. On 25-Oct-2007, the patient presented to the office. The patient's arm was red and swollen. The doctor stated that the patient's arm had induration, slight calor and erythema. The patient was being treated with KEFLEX 500mg twice a day, BENADRYL and TYLENOL. The patient was to return to the doctor's office if symptoms worsen or did not improve. Additional has been requested.				Y					U	10/24/2007	10/24/2007	0	Unknown	OTH	OTH	aspirin; LIPITOR; LOTENSIN; HYDRAZIDE (HYDROCHLOROTHIAZIDE); oxycodone	Renal insufficiency; Hypertension; Hyperlipidaemia; Polyp; Drug hypersensitivity			WAES0710USA05768	1						1	Erythema; Induration; Oedema peripheral; Pain in extremity; Skin warm	FLUX~UNKNOWN MANUFACTURER~0555U~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0322673	08/06/2008	GA	42.0	42		F	07/30/2008	Information has been received from a 42 year old female consumer allergic to penicillin and many pain medications who was vaccinated (route and site not reported) on 09-OCT-2007 with PNEUMOVAX 23 (lot # 655766/0038U) and FLUVIRIN (Novartis). Concomitant therapy included ZYRTEC, EFFEXOR, and hormonal contraceptives (unspecified). On the evening of 09-OCT-2007, post vaccination, the caller stated she had developed an allergic reaction. Per the patient, her arm swelled up and began getting real red, 2 days later she could barely use the arm because it was very painful. The swelling and redness lasted about 1 week to 10 days. The caller stated that there was still a knot at the injection site. The caller stated she had received pneumonia vaccine in the past with no adverse effect. The caller sought unspecified medial attention and stated that her symptoms had improved since they started. Additional information has been requested.				Y					N	10/09/2007	10/09/2007	0	None	OTH	OTH	ZYRTEC; hormonal contraceptives; EFFEXOR	Penicillin allergy; Drug hypersensitivity			WAES0710USA05793	1						1	Erythema; Hypersensitivity; Injected limb mobility decreased; Injection site nodule; Mobility decreased; No reaction on previous exposure to drug; Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0038U~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0322789	08/06/2008					F	07/30/2008	Information has been received from a physician concerning a female over 65 years old who was vaccinated with a dose of PNEUMOVAX (lot # not reported).  Concomitant therapy included influenza virus vaccine (unspecified).  Subsequently the patient experienced 102 degree fever and body aches.  The patient's status was not reported.  Additional information has been requested.									U				Unknown	OTH	OTH	Unknown		Unknown		WAES0711USA00028	1						1	Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0322795	08/06/2008					M	07/30/2008	Information has been received from a physician concerning a male who a week ago on approximately 24-OCT-2007 was vaccinated with PNEUMOVAX.  Concomitant therapy included influenza virus vaccine (unspecified) same day and in the same arm.  On the same day of the vaccination, the patient experienced pain, swelling, redness at the injection site and fever.  By the next day the pain, swelling and redness on the arm as well as fever went away.  However, swelling on the patient's face had occurred.  Unknown medical attention was sought.  The outcome on face swelling was unknown.  No product quality complaint was involved.  Additional information has been requested.									Y	10/24/2007	10/24/2007	0	None	OTH	OTH	Unknown		Unknown		WAES0711USA00240	1						1	Injection site erythema; Injection site pain; Injection site swelling; Pyrexia; Swelling face	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0322801	08/06/2008	PA	72.0	72		F	07/30/2008	Information has been received from a certified medical assistant concerning a 72 year old female patient with hypertension, chronic obstructive pulmonary disease and gastrooesophageal reflux disease and a history of cerebrovascular accident and diverticulitis who on 23-OCT-2007, was vaccinated IM into the right arm with a first 0.5ml dose of PNEUMOVAX 23 (Lot# 658555/0964U).  Concomitant therapy included influenza virus vaccine (unspecified) administered into the left arm, KLOR-CON, COZAAR, ZOCOR, CARTIA XT, metoprolol, AGGRENOX, ADVAIR, PRILOSEC and LASIX.  Subsequently, the patient experienced arm pain, redness at the injection site, warmth at the injection site and swelling in the right arm.  Unspecified medical attention was sought.  Laboratory diagnostic studies included an ultrasound of the arm which was reported as negative for deep vein thrombosis (DVT).  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  This is one of 4 reports from the same source.  Additional information has been requested.				Y					U	10/23/2007			brachial artery, negative for deep vein thrombosis (DVT)	OTH	OTH	AGGRENOX, CARTIA XT, ADVAIR, LASIX, COZAAR, metoprolol, PRILOSEC, KLOR-CON, ZOCOR	Hypertension; Gastrooesophageal reflux disease; Chronic obstructive pulmonary disease	Cerebrovascular accident; Diverticulitis		WAES0711USA00423	1						1	Injection site erythema; Injection site warmth; Oedema peripheral; Pain in extremity; Ultrasound scan normal	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0964U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0322931	08/06/2008					F	07/30/2008	Information has been received from a registered nurse concerning a female between 70 to 80 years of age, who on 11-OCT-2007, was vaccinated intramuscularly with a 0.5mL dose of PNEUMOVAX 23.  Concomitant therapy influenza virus vaccine (unspecified).  Subsequently, the patient developed redness at the injection site.  The patient sought unspecified medical attention.  No laboratory diagnostics were performed.  The patient recovered on an unspecified date.  No product quality complaint was involved.  This report is one of three from the same source.  Additional information has been requested.				Y					Y	10/11/2007			None	OTH	OTH			Unknown		WAES0711USA00899	1						1	Injection site erythema	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0322936	08/06/2008	AZ	71.0	71		F	07/30/2008	Information has been received from a physician concerning a 71 year old female with a history of drug allergy/reaction to tetanus vaccine (local redness after tetanus booster 15 years ago) and hydrocodone and no pertinent medical history. The patient had no illness at the time of being vaccinated. On 31-OCt-2007, the patient was vaccinated with a first dose of PNEUMOVAX 23 vaccine (lot # 655765/0061U) 0.5 ml subcutaneously in the right arm. Concomitant therapy also given on 31-OCT-2007 in the left arm included a first dose of ZOSTAVAX vaccine (lot # 658604/1088U), and influenza virus vaccine (Sanofi Pasteur (lot # 112515AA). Other concomitant therapy included LEXAPRO and blood pressure medicine unspecified. On 31-OCT-2007 (also reported as 01-NOV-2007), the patient experienced erythema, swelling, pain, and warmth from her neck to elbow where PNEUMOVAX 23 vaccine was given. The immediate area around the injection site was normal in color. On 02-NOV-2007, the patient was seen by the physician and was started on therapy with KEFLEX. At the time of reporting, the outcome was unknown. Additional information was received from the physician. On 02-NOV-2007, the patient visited the physician's office. The patient had swelling and erythema over her right arm extending from the elbow to deltoid/base of neck. No diagnostic tests were performed. The patient was treated as cellulitis with KEFLEX. On an unspecified date, the patient recovered. No additional information is expected.				Y					Y	10/31/2007	10/31/2007	0	None	PVT	PVT	[therapy unspeicifed]; LEXAPRO	Drug hypersensitivity	Localised erythema		WAES0711USA00961	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~112515AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0061U~1~SC~UN~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~1088U~1~UN~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0322945	08/06/2008		35.0			F	07/30/2008	Information has been received from a registered nurse concerning a 35 year old female who on 30-OCT-2007 was vaccinated intramuscularly with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine, (lot # 0099U) and concomitantly was vaccinated with influenza virus vaccine (unspecified). It was reported that the patient experienced soreness and pain up her arm but not at the injection site, with a rash or redness of the blood vessels of her hands and wrists. She was treated with ibuprofen and ice. It was not known if the patient had received a pneumococcal 23 v polysaccharide vaccine in the past. The patient sought unspecified medical attention by phone. At the time of the report, it was unknown if the patient recovered. The nurse reported on two other patients that experienced adverse events after receiving pneumococcal 23v polysaccharide vaccine (0711USA02461 and 0711USA00610). The patient worked with 45 persons that were vaccinated during a vaccine clinic at their company. A total of 45 persons received the influenza virus vaccine (unspecified) and 12 persons received pneumococcal 23v polysaccharide vaccine. There have been no other adverse symptoms reported. Additional information has been requested.				Y					U	10/30/2007			Unknown	OTH	OTH			Unknown		WAES0711USA02460	1						1	Erythema; Pain in extremity; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0322947	08/06/2008					F	07/30/2008	Information has been received from a registered nurse concerning a female who on 30-OCT-2007 was vaccinated intramuscularly with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine, (lot # 0099U). Concomitantly the patient was vaccinated with influenza virus vaccine (unspecified). The patient received the influenza virus vaccine (unspecified) and the pneumococcal 23v polysaccharide vaccine in one arm each. It was reported that the patient experienced soreness and pain in her arm, but not at the injection site, with a rash or redness of the blood vessels of her hands and wrists. She was treated with ibuprofen and ice. It was not known if the patient had received pneumococcal 23v polysaccharide vaccine in the past. It was reported that a total of 45 persons who worked together were vaccinated during a vaccine clinic at their company. All patients received the influenza virus vaccine (unspecified) and 12 persons received the pneumococcal 23v polysaccharide vaccine. There have been no adverse symptoms reported. The nurse reported that two other patients had adverse events after receiving the pneumococcal 23v polysaccharide vaccine. (WAES #0711USA00610 and WAES # 0711USA02460). In follow-up the registered nurse stated that the problem that the patient had did not have anything to do with the vaccine. She stated that it was a coincidence that the two events occurred in the shot time frame. Additional information is not expected.				Y					U	10/30/2007			Unknown	OTH	OTH			Unknown		WAES0711USA02461	1						1	Erythema; Pain in extremity; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0322952	08/06/2008		64.0			F	07/30/2008	Information has been received from a registered nurse concerning a 64 year old female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient experience redness, swelling and discomfort in arm that she received the immunization with pneumococcal 23v polysaccharide vaccine. The patient's status was not reported. There was no product quality complaint involved. No further information is available.									U				None	OTH	OTH			Unknown		WAES0711USA00583	1						1	Erythema; Pain in extremity; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0322955	08/06/2008					F	07/30/2008	Information has been received from a registered nurse concerning a female who on 30-OCT-2007 was vaccinated with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine, (Lot # 0099U) and concomitantly was vaccinated with influenza virus vaccine (unspecified). It was reported that the patient experienced soreness of the arm, not the injection site, and a fever within hours of receiving the vaccines. The fever had gone to 102 Fahrenheit. She had seen her doctor each day since then. It was reported that the patient also sought medical attention by phone. It was unknown if the patient had received pneumococcal 23v polysaccharide vaccine in the past. The registered nurse reported that two other patients experienced adverse reactions after receiving pneumococcal 23v polysaccharide vaccine (WAES # 0711USA02460 and WAES # 0711USA02461). The patient was vaccinated with a total of 45 persons. They all worked together and were vaccinated during a vaccine clinic at their company. A total of 45 persons received the influenza virus vaccine (unspecified) and 12 persons received the pneumococcal 23v polysaccharide vaccine. There have been no other adverse symptoms reported. In follow-up the registered nurse stated that the problem that the patient had did not have anything to do with the vaccine. She stated that it was coincidence that the two events occurred in the shot time frame. Additional information is not expected.										10/30/2007	10/30/2007	0	body temp 10/30/07 102 degrees	OTH	OTH			Unknown		WAES0711USA00610	1						1	Body temperature increased; Pain in extremity; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0322957	08/06/2008		30.0			F	07/30/2008	Information has been received from a registered nurse concerning a female in her 30's or 40's who in October 2007, earlier this week, was vaccinated with pneumococcal 23v polysaccharide vaccine. It was thought that this was the first dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included influenza virus vaccine (unspecified) also given on the same date. In approximately October 2007, the patient contacted her physician because she had developed redness, itching, and swelling of her hands as well as a high fever. At the time of reporting, the outcome of the events was unknown. Follow-up information was received from the registered nurse who reported that the patient thought her problem was vaccine related, but further investigation by her physician determined the problem was not vaccine related. It was just a coincidence that she happened to be vaccinated at the time of the problem. No additional information is expected.				Y					U	10/01/2007	10/01/2007	0	body temp 10/07 - high fever	OTH	OTH			Unknown		WAES0711USA00613	1						1	Body temperature increased; Erythema; Oedema peripheral; Pruritus; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0322959	08/06/2008		51.0	51		M	07/30/2008	Information has been received from a consumer concerning her 51 year old father who on 12-NOV-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Suspect vaccination included influenza virus vaccine (unspecified) and tetanus toxoid. On 12-NOV-2007 the patient experienced very sore arm and flu-like symptoms. The patient's very sore arm and flu-like symptoms persisted. No further information is available.									N	11/12/2007	11/12/2007	0	Unknown	OTH	OTH	Unknown		Unknown		WAES0711USA03047	1						1	Influenza like illness; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0322963	08/06/2008	CA				F	07/30/2008	Information has been received from a Registered Nurse concerning a female who was vaccinated with pneumococcal 23 v polysaccharide vaccine. Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient experienced an elevated response and flu-like symptoms. Subsequently, the patient recovered from her experiences. Additional information has been requested.									Y				Unknown	OTH	OTH			Unknown		WAES0711USA01767	1						1	Influenza like illness	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0322965	08/06/2008	OH	62.0	62		F	07/30/2008	Information has been received from a nurse practitioner and a 62 year old white female registered nurse consumer (220 pounds, 64 inches) with hypothyroidism and high blood pressure and no history of drug reactions/allergies. On 22-OCT-2007, the patient received a first dose of zoster vaccine live (Oka/Merck) (lot # 658081/0743U) in the right arm in the afternoon. On 26-OCT-2007 at the time of being vaccinated, the patient hand no illness. On 26-OCT-2007, the patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 655499/0988F) subcutaneously in the left arm in the evening. Concomitant therapy also given on 26-OCT-2007 included a 10 plus dose of FLUVIRIN (lot # 86435) given in the right arm about 1:30 PM. Other concomitant therapy included SYNTHROID, ezetimibe (+) simvastatin (MSD), metoprolol, sitagliptin phosphate (MSD), OMACOR, MOBIC, vitamins (unspecified) and niacin. On 27-OCT-2007, in the evening, the patient experienced arthralgia all over her body, nausea and a fever. At the injection site she developed a golf-sized lump that was warm, red and swollen. She was at the nurse's office on 29-OCT-2007 and the morning office manager told her that she had a small bruise at the injection site after getting pneumococcal 23v polysaccharide vaccine. The nurse practitioner also reported that the patient experienced an unspecified local reaction. Subsequently, the patient recovered from the events. Additional information was received from the registered nurse consumer. The patient had also experienced malaise. No diagnostic tests were performed. Subsequently, the patient recovered from the events. No additional information is expected.									Y	10/26/2007	10/27/2007	1	None	PVT	PVT	VYTORIN; SYNTHROID; MOBIC; metoprolol; niacin; OMACOR; JANUVIA; vitamins (unspecified)	Hypothyroidism; Blood pressure high			WAES0711USA00727	1						1	Arthralgia; Injection site bruising; Injection site erythema; Injection site mass; Injection site swelling; Injection site warmth; Local reaction; Malaise; Nausea; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~86435~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0988F~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0322968	08/06/2008	MO	54.0	54		F	07/30/2008	Information has been received from an physician concerning a female who on 02-NOV-2007 was vaccinated SQ with pneumococcal 23v polysaccharide vaccine (Lot #658447/1132U). Concomitant therapy included influenza virus vaccine (unspecified). Subsequently the patient experienced soreness at the injection site 5 minutes post vaccination. The patient called the office the same day about 1.5 hours post vaccination complaining of soreness and swelling at the injection site. The patient was treated with BENADRYL and cold compresses. On 04-NOV-2007, the swelling had increased in size and the patient went to the ER. The patient was treated with antibiotics for possible cellulitis. The patient was not hospitalized. As of 07-NOV-2007, the patient had not recovered. Follow up information: It was reported that on 02-NOV-2007 at 11:00 the 54 year old female patient developed a large arm, raised area on right arm and continued to swell. The patient went to the emergency room on weekend. The patient recovered on 05-NOV-2007. Additional information has been requested.				Y					Y	11/02/2007	11/02/2007	0	Unknown	OTH	OTH			None		WAES0711USA01768	1						1	Cellulitis; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1132U~1~SC~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0322979	08/06/2008	TX	44.0			F	07/30/2008	Initial and follow-up information has been received from a physician's office manager, pharmacist, and registered nurse concerning a 44 year old female patient who on 01-NOV-2007 at 08:00 was vaccinated IM in the left deltoid with a first dose of PNEUMOVAX (lot #657145/1226U). Concomitant vaccination included FLUZONE (Lot# U2466AA) administered in the right deltoid. On 01-NOV-2007, the patient experienced soreness, warmth and blotchy red discoloration at the injection site and a fever. The patient visited the school district nurse. The patient's outcome was not reported. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No additional information is requested.									U	11/01/2007	11/01/2007	0	Unknown	OTH	PVT			Unknown		WAES0711USA02352	1						1	Injection site discolouration; Injection site pain; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U2466AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1226U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0322980	08/06/2008	TX	54.0			F	07/30/2008	Initial and follow-up information has been received from a physician's office manager, pharmacist, and a registered nurse concerning a 54 year old white female patient who on 01-NOV-2007 at 08:00 was vaccinated IM in the left buttocks with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 657145/1226U). Concomitant vaccination included influenza virus vaccine (unspecified) (Lot# U2466AA) administered in the left deltoid. On 01-NOV-2007 the patient experienced fever with aching and chills, decreased arm mobility and redness at the injection site. The patient visited the school district nurse. The patient's outcome was not reported. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.									U	11/01/2007	11/01/2007	0	Unknown	OTH	PVT	Unknown		Unknown		WAES0711USA02353	1						1	Chills; Injected limb mobility decreased; Injection site erythema; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2466AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1226U~1~IM~GM~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0322981	08/06/2008	TX	58.0			F	07/30/2008	Initial and follow-up information has been received from a physician's office manager, pharmacist, and a registered nurse concerning a 58 year old female patient with a gastrointestinal illness, and allergies, who on 01-NOV-2007 at 08:00 was vaccinated IM in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 657145/1226U). Concomitant vaccination included influenza virus vaccine (unspecified) (Lot# U2466AA) administered in the left deltoid. The night before receiving pneumococcal 23v polysaccharide vaccine the patient experienced nausea and did not feel well in the morning. On 01-NOV-2007, the patient experienced faintness and sweating 5 hours after the injection. The patient experienced decreased food intake. It was reported that the faintness and decreased food intake were apparently related to the gastrointestinal illness. The patient visited the school district nurse. The patient recovered on 02-NOV-2007. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.									Y	11/01/2007	11/01/2007	0	Unknown	OTH	PVT		Gastrointestinal disorder; Hypersensitivity	Nausea		WAES0711USA02356	1						1	Decreased appetite; Dizziness; Hyperhidrosis	FLU3~SANOFI PASTEUR~U2466AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1226U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0322993	08/06/2008		65.0	65		F	07/30/2008	Information has been received from a physician concerning a 65 year old female patient with hypothyroidism, osteoarthritis, depression, menopause, asthma and allergy to AUGMENTIN who on 02-NOV-2007 was vaccinated IM with her first dose of pneumococcal 23v polysaccharide vaccine, lot #655152/0889F. Concomitant therapy included influenza virus vaccine (unspecified) given the same day in the other arm, SYNTHROID, estradiol, LEXAPRO, and AMBIEN. The patient developed redness and rash at injection site and sought medical attention in office, but no treatment was required. Subsequently, she recovered. Additional information has been requested.				Y					Y	11/02/2007	11/02/2007	0	Unknown	OTH	OTH	LEXAPRO; estradiol; SYNTHROID; AMBIEN	Hypothyroidism; Osteoarthritis; Depression; Menopause; Asthma; Allergic reaction to antibiotics			WAES0711USA05783	1						1	Injection site erythema; Injection site rash	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0889F~1~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0323004	08/06/2008	AZ	68.0			F	07/30/2008	Information has been received from a 68 year old female consumer who in 2006 (exact date not reported) was vaccinated (site and route not reported ) with pneumococcal 23v polysaccharide vaccine (lot# not reported). Concomitant therapy included influenza virus vaccine (unspecified) given in the opposite arm. In 2006 (exact date not reported), post vaccination, the patient's whole arm swelled and got red. No lab diagnostic test were performed. The patient did receive unspecified medical attention and recovered. No additional information is expected.				Y					Y				None	OTH	OTH			Unknown		WAES0711USA03686	1						1	Erythema; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0323370	08/06/2008		60.0			M	07/30/2008	Information has been received from a pharmacist concerning a male in his sixties who on unspecified dates in September 2007 during a vaccination clinic, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included influenza virus vaccine (unspecified). In September 2007 one or two days following vaccination with pneumococcal 23v polysaccharide vaccine the patient present to his physician with injection site reaction described as a cellulitis. The patient was given a prescription for antibiotic (name unspecified). The relationship of the event to therapy with pneumococcal 23v polysaccharide vaccine was report as unknown. The outcome of the event was not reported. No product quality complaint was involved. Additional information has been requested.				Y					U					OTH	OTH			Unknown		WAES0711USA03230	1						1	Injection site cellulitis	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0323371	08/06/2008					F	07/30/2008	Information has been received from a pharmacist concerning a female (age not reported) who on an unspecified date in September 2007 during a vaccination clinic, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included influenza virus vaccine (unspecified). In September 2007 one or two days following vaccination with pneumococcal 23v polysaccharide vaccine the patient developed an injection site reaction described as a infection and was referred to her physician. The patient was given a prescription for CIPRO and BACTRIM antibiotics. The physician considered hospitalizing the patient but had not hospitalized her yet. The relationship of the event to therapy with pneumococcal 23v polysaccharide vaccine was reported as unknown. The outcome of the event was not reported. No product quality complaint was involved. Additional information has been requested.				Y					U	09/01/2007				OTH	OTH			Unknown		WAES0711USA03231	1						1	Injection site infection	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0323380	08/06/2008		66.0	66		F	07/30/2008	Information has been received from a pharmacist concerning a 66 year old female with a penicillin and cephalosporin allergy who on approximately 09-NOV-2007 was vaccinated intramuscularly with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot #0991U). Concomitant vaccination on the same day included influenza virus vaccine (unspecified) (manufacturer unknown) into the other arm. On 09-NOV-2007, the patient developed swelling in both arms. On 20-NOV-2007, the patient was seen by the physician. She was treated with BENADRYL and heat pads. The patient contacted the pharmacist. On 12-NOV-2007, the patient recovered. Additional information has been requested.				Y					Y	11/09/2007	11/09/2007	0	None	OTH	OTH	Unknown	Penicillin allergy; Hypersensitivity			WAES0711USA03416	1						1	Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0323399	08/06/2008		31.0	31		F	07/30/2008	Information has been received from a health professional concerning a 31 year old female with a history of asthma who on 07-JAN-2008 was vaccinated IM in the left deltoid with the first dose of pneumococcal 23v polysaccharide vaccine (654977/0888F). Concomitant therapy included influenza virus vaccine (unspecified) IM in the right deltoid. On approximately 07-JAN-2008 the patient experienced injection site reaction and came back to the employee health department on 09-JAN-2008. Per the reporter, the injection site reaction was very painful, warm and red. Swelling at the injection site was 11cm wide and 7 cm long. The patient sought unspecified medical attention. Subsequently, the patient recovered from injection site reaction. The patient had been treating self with BENADRYL. Additional information has been requested.									Y	01/07/2008	01/07/2008	0	Mantoux test 01/07/08	OTH	OTH			Asthma		WAES0801USA03659	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Tuberculin test	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0888F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0323412	08/06/2008	FL	76.0	76		M	07/30/2008	Information has been received from a Certified Medical Assistant concerning a 76 year old male patient with drug allergy to triazolam who on 30-NOV-2007 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine lot # 659147/1381U. Concomitant therapy included influenza virus vaccine (unspecified), vitamins (unspecified) and zinc (unspecified). On 30-NOV-2007, the patient developed injection site redness, swelling, warmth and pain. Medical attention was sought by the patient. At the time of this report patient had not recovered. No other information was available at this time. Additional information has been requested.				Y					N	11/30/2007	11/30/2007	0	Unknown	OTH	OTH	vitamins (unspecified); zinc (unspecified)	Hypersensitivity			WAES0712USA00333	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1381U~1~SC~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0323421	08/06/2008	MI				F	07/30/2008	Information has been received from a pharmacy technician and a licensed practical nurse concerning a female patient (age not reported) who on 29-NOV-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot# 657626/1084U). The licensed practical nurse reported that the patient was vaccinated at the same time in the same arm with a flu vaccine (unspecified). On 30-NOV-2007, the patient called the office to report that she had warmth and redness at the injection site and her arm was very inflamed and hot. The pharmacy technician noted that it seemed like more patients had this experience this year than patients who received the vaccine last year. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.				Y					N	11/29/2007	11/30/2007	1	Unknown	PVT	OTH	Unknown		Unknown		WAES0801USA02069	1						1	Inflammation; Injection site erythema; Injection site warmth; Skin warm	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1419U~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0323451	08/06/2008	VA				F	07/30/2008	Information has been received via a company representative, from a female nurse (age not specified) with diabetes, who in October 2007, was vaccinated in the arm with a dose of pneumococcal 23v polysaccharide vaccine (lot # not reported), and with a dose influenza virus vaccine (unspecified). In October 2007, following the vaccinations (duration to onset not specified), the nurse developed a temperature of 103 degrees, and felt like her arm where vaccinations occurred was going to fall off. Subsequently, the nurse recovered (duration of events not specified). The nurse did not seek medical attention. Additional information has been requested.									Y	10/01/2007			None	OTH	OTH	Unknown	Diabetes			WAES0801USA00382	1						1	Injection site pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0323453	08/06/2008	NY	79.0	79		M	07/30/2008	Information has been received from a physician concerning a male with hypertension who in December 2007, was vaccinated SC with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine concomitantly with a dose of influenza virus vaccine (unspecified). Other concomitant therapy included ECOTRIN, MONOPRIL and simvastatin (MSD). Subsequently, the patient developed swelling, redness and pain at the injection site. Medical attention was sought at the physician's office. The patient was treated with over the counter BENDADRYL. Subsequently, the patient recovered.  Additional information has been requested.				Y					Y	12/01/2007			None	OTH	OTH	ECOTRIN; MONOPRIL; ZOCOR	Hypertension			WAES0801USA00569	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~SC~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0323455	08/06/2008					U	07/30/2008	Information has been received via a company representative, from a nurse, concerning a patient (age and gender not reported) at another office, who was vaccinated in the arm (date not specified) with a dose of pneumococcal 23v polysaccharide vaccine (lot # not reported), and possibly with a dose of influenza virus vaccine (unspecified). Following the vaccinations (duration to onset not specified), the patient developed an elevated temperature, possibly of 103 degrees, and felt arm where the vaccinations were administered was going to fall off. At the time of this report, it was unknown if the patient recovered.  Additional information is not expected.									U				None	OTH	OTH	Unknown		Unknown		WAES0801USA00713	1						1	Body temperature increased; Limb discomfort	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0323462	08/06/2008	RI	69.0	69		F	07/30/2008	Information has been received from a registered nurse, regarding a 69 year old female patient with no pertinent medical history, who on 12-DEC-2007 was vaccinated SC in the arm, with a dose, 0.5 mL, of pneumococcal 23v polysaccharide vaccine (lot #658451/0963U). Concomitant vaccine therapy included a dose of influenza virus vaccine (manufacturer unspecified). On 12-DEC-2007, the patient developed an injection site reaction described as redness and a lump at the injection site, with soreness of her arm. Treatment included ALEVE, with little relief of the symptoms. The patient contacted the physician. At the time of this report, the patient was recovering from the events. Additional information has been requested.				Y					N	12/12/2007	12/12/2007	0	None	OTH	OTH			None		WAES0712USA07258	1						1	Injection site erythema; Injection site mass; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~SC~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0323463	08/06/2008	RI	24.0	24		F	07/30/2008	Initial and follow up information has been received from a registered nurse, concerning a 24 year old female Caucasian with chronic sinusitis, RAD, and allergic rhinitis, who on 06-NOV-2007, at 4:00 pm, was vaccinated SC in the arm, with the first dose, 0.5 mL, of pneumococcal 23v polysaccharide vaccine (lot #658449/0989U). The patient had an episode of chronic sinusitis at the time of vaccination. Concomitant vaccine therapy included the first dose, IM in the right deltoid, of NOVARTIS (LOT #80433), and the first dose, IM in the left deltoid, of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (SP) (lot #C2863AA). On 07-NOV-2007, the patient developed an injection site reaction, described as a warm macule, or a 12 X 12 centimeter area of redness and swelling. The area was so tender and painful, that she couldn't lift her arm. She also had a fever of 104 degrees F. Treatment included prednisone, PERCOCET and KEFLEX. After a few days, the patient recovered from the event. Additional information is not expected.				Y					Y	11/06/2007	11/07/2007	1	body temp 11/07/07 104 degre	PVT	PVT		Chronic sinusitis	Rhinitis allergic		WAES0712USA07267	1						1	Body temperature increased; Incorrect route of drug administration; Injected limb mobility decreased; Injection site erythema; Injection site pain; Injection site rash; Injection site swelling; Injection site warmth; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80433~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0989U~1~SC~~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2863AA~1~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0323562	08/06/2008	OR	69.0	69		M	07/30/2008	Information has been received from a registered nurse concerning a 69 year old white male. The patient said he did not have any prior adverse reactions. On 04-OCT-2007 the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot #657143/0380U) intramuscularly in the left deltoid at 10:00 am. Concomitant therapy included influenza virus vaccine (unspecified) (Lot #AFLLA040AA) (GlaxoSmithKline) intramuscularly in the left deltoid at 10:00 am. One week after the injection, on approximately 11-OCT-2007, the patient reported that he developed redness and pain in the left upper arm, which lasted one week and did not require any other interventions. The patient has recovered. No further information is expected.									Y	10/04/2007	10/11/2007	7	Unknown	PVT	PVT			Unknown		WAES0802USA03091	1						1	Erythema; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA040AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0380U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0323570	08/06/2008	IL				U	07/30/2008	Information has been received from a health professional concerning an unknown number of patient's who in 2007 were vaccinated with pneumococcal 23v polysaccharide vaccine (Lot # not reported) and developed cellulitis at the injection site. There were no patient specifics provided. A few of the patients my have received the influenza virus vaccine (unspecified) concomitantly. The reporter did not know if the pneumococcal 23v polysaccharide vaccine was the first or second for the patients. The patients sought unspecified medical attention. On an unspecified date, the patients recovered from the injection site cellulitis. No additional information was provided. Additional information has been requested.									Y				Unknown	OTH	OTH			Unknown		WAES0802USA04478	1						1	Injection site cellulitis	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0323832	08/06/2008	GA	52.0			F	07/30/2008	Information has been received from a 52 year old female consumer with penicillin and erythromycin allergies and no pertinent medical history who on 14-NOV-2007 was vaccinated (route not reported) in left arm with a 1ml dose of pneumococcal 23v polysaccharide vaccine (Batch 657042, lot#1345U). Concomitant therapy included influenza virus vaccine (unspecified). On 14-NOV-2007, post vaccination, the patient experienced pain and a burning sensation on the left arm which was the injection site right after receiving the pneumococcal 23v polysaccharide vaccine. The patient reported that the injection site became swollen, up to half the size of an egg and turned purple, then green and later yellow. This lasted for a week or more. The patient reported that she wakes up at night because her arm hurts and the pain now travels up to her neck. Per patient, to date, the swelling is gone but the pain and burning are still there. The patient did not receive medical attention and no diagnostic lab test were performed. At the time of this report the patient had not removed. Additional information has been requested.									N	11/14/2007	11/14/2007	0	None	OTH	OTH	Unknown	Penicillin allergy, Allergic reaction to antibiotics			WAES0712USA02829	1						1	Injection site discolouration; Injection site irritation; Injection site pain; Injection site swelling; Neck pain; Pain in extremity; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1345U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0323838	08/06/2008		67.0			F	07/30/2008	Information has been received from a pharmacist concerning a 67 year old female with no pertinent medical history or drug reactions/allergies who in 2006 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot# unknown) and did not experience any problems. On an unspecified date, the patient was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included influenza virus vaccine (unspecified). Subsequently on an unspecified date the patient experienced a reaction that was very red and swollen at the injection site and flu-like symptoms that lasted for 3 days. Medical attention was sought. At the time of reporting the patient had recovered. No further information was available. Additional information has been requested.				Y					Y				Unknown	OTH	OTH			None		WAES0712USA03721	1						1	Influenza like illness; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~2~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0324212	08/06/2008		64.0			F	07/30/2008	Information has been received from a nurse concerning a 64 year old female with no allergies or drug reactions who on 03-DEC-2007 was vaccinated (site and route not reported) with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot#658200/0804U). On the same day the patient was concomitantly vaccinated (site and route not reported) with a influenza virus vaccine (unspecified). On 05-DEC-2007, the nurse reported that the patient developed redness and pain at injection site and fever 48 hours post vaccination. The patient sought medical attention and was prescribed antibiotic by the physician. No further information available. Additional information has been requested.				Y					N	12/03/2007	12/05/2007	2	Unknown	OTH	OTH			Unknown		WAES0712USA02326	1						1	Injection site erythema; Injection site pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0804U~1~~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0324216	08/06/2008	OH	70.0	70		F	07/30/2008	Information has been received from a physician concerning a 70 year old female. The physician reported that the patient had a reaction to either FLUVAX or pneumococcal 23v polysaccharide vaccine (MSD). It was a hive like reaction. As of 30-NOV-2007, the out come was unknown. Additional information is not expected.									U	11/23/2001			Unknown	UNK	UNK	Unknown		Unknown		WAES0712USA02515	1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~SC~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0324217	08/06/2008	SC	6.0	6		M	07/30/2008	Information has been received from a physician concerning a 6 year old Caucasian male with gastrooesophageal reflux disease, chronic sinusitis, reactive airways disease and food allergies, who on 12-NOV-2007 was vaccinated intramuscularly with pneumococcal 23v polysaccharide vaccine into the right arm (lot# 656222/0381U). Concomitant therapy included FLUMIST and varicella virus vaccine live (unspecified) (manufacturer unknown), into the opposite arm. Other concomitant therapies included PREVACID and SINGULAIR. On 12-NOV-2007, the patient experienced a significant injection site reaction, edema and erythema almost immediately following the pneumococcal 23v polysaccharide vaccination. The injection site arm was affected from the shoulder area down the arm 2/3 of the way to the elbow. The area was warm, erythematous, and swollen. The patient was given steroids and diphenhydramine as treatment and the reaction resolved in a couple of days. Medical attention was sought, treated for the injection site reaction. Additional information has been requested.				Y					Y	11/12/2007	11/12/2007	0	None	OTH	OTH	PREVACID; SINGULAIR	Gastrooesophageal reflux disease; Chronic sinusitis; Reactive airways disease; Food allergy			WAES0712USA02595	1						1	Injection site erythema; Injection site oedema; Injection site swelling; Injection site warmth	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|PPV~MERCK & CO. INC.~0381U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|VARCEL~UNKNOWN MANUFACTURER~~UNK~UN~LA~VARICELLA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0324236	08/06/2008	TN				M	07/30/2008	Information has been received from a licensed practical nurse concerning a male with arthritis who in October or November 2007 was vaccinated with pneumococcal 23v polysaccharide vaccine. Concomitantly the patient was vaccinated with influenza virus vaccine (unspecified). It was reported that in January 2008, the patient developed right arm pain. The patient had a diagnosis of arthritis. The patient's arthritis was monitored by the physician; however, the date of the last office visit was unspecified. The nurse did not have access to the patient's medical record when reporting the adverse symptoms. Follow-up information indicated that the patient was diagnosed with serum sickness as a result of the vaccination with PNEUMOVAX 23. The patient experienced muscle and joint pain, episodes of joint lock up, extremely dry skin, and an onset of aging. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information is not available.				Y					N		01/01/2008			OTH	OTH	influenza virus vaccine	Arthritis	Arthritis, Diabetes, Diabetic neuropathy.		WAES0802USA00327	1						1	Arthralgia; Arthritis; Condition aggravated; Dry skin; Joint lock; Myalgia; Pain in extremity; Premature ageing; Serum sickness	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0324276	08/06/2008					M	07/30/2008	Information has been received from a registered nurse concerning a male over 70 years of age who, on an unspecified date, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot# 657143/0380U). Concomitant vaccination included influenza virus vaccine (unspecified), administered in the opposite arm. Subsequently, the patient developed an injection site reaction with redness, swelling, and tenderness. The reaction was treated with cool cloths and ADVIL or TYLENOL for pain if needed. The patient called the office. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.				Y					U				Unknown	OTH	OTH			Unknown		WAES0805USA00870	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0380U~1~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0324326	08/06/2008	MI	65.0			F	07/30/2008	Information has been received from a health professional concerning a 65 year old white female with no pertinent medical history or drug reactions/allergies who on 15-OCT-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 657626/1084U) IM in the right deltoid. Concomitant therapy on the same day included influenza virus vaccine (unspecified). On 17-OCT-2007, the patient called the office at 2:53PM and complained of dizziness, headache behind eye, fever was 101.2, right arm was swollen and hot to touch. The patient had asked to get a flu shot and pneumococcal 23v polysaccharide vaccine in the same arm on 15-OCT-2007. Diagnosis was right arm cellulitis and allergic reaction. The treatment included KEFLEX 500mg BID for 10 days, BENADRYL 25 mg at bedtime and ibuprofen HCl 200mg TID when needed. Both sites were involved. Erythematous patches. Temperature was 99.5. At the time of reporting the patient had recovered. Additional information is not expected.				Y					Y	10/15/2007	10/17/2007	2	temperature measurement 10/17/07 101.2; temperature measurement 99.5	PVT	OTH			None		WAES0805USA01976	1						1	Body temperature increased; Cellulitis; Dizziness; Erythema; Headache; Hypersensitivity; Oedema peripheral; Pyrexia; Skin warm	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1084U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0324330	08/06/2008	CA	68.0	68		F	07/30/2008	Information and follow up has been received from a health professional concerning a 68 year old patient with an allergy to tape and OMICEF, hypertension, hyperlipidemia, major depression and low back pain who on 16-OCT-2003 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot# not provided). Concomitant therapy included the flu vaccine (lot# not reported). On 16-OCT-2003, the patient experienced severe injection site reaction including redness, pain and swelling at the injection site. Subsequently, the patient recovered on 20-OCT-2003 from severe injection site reaction including redness, pain and swelling at the injection site. The patient also received pneumococcal 23v polysaccharide vaccine 5 years prior to this. Additional information has been requested.				Y					Y	10/16/2003	10/16/2003	0	Unknown	PVT	PVT		Adhesive tape allergy; Hypertension; Hyperlipidaemia; Depression; Low back pain; Hypersensitivity			WAES0805USA02116	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~2~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0324334	08/06/2008	CA	71.0	71		M	07/30/2008	Information has been received from a physician concerning a 71 year old white male with arthritis, chronic obstructive pulmonary disease, asthma, hypertension, emphysema, hyperlipidaemia, blurred vision, difficulty swallowing, prostate problems and erectile dysfunction and a history of dyspepsia, who on 24-OCT-2007 was vaccinated intramuscularly in the right arm with pneumococcal 23v polysaccharide vaccine (Lot 658449/0989U). The patient previously received a dose of									Y	10/24/2007	11/29/2007	36	Unknown	PVT	PVT					WAES0805USA02751	1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~79719~7+~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0989U~2~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0324410	08/06/2008	NJ	58.0			F	07/30/2008	Information has been received from a physician concerning a 58 year old female with a penicillin allergy and allergies to CIPRO and KEFLEX and a history of breast cancer who on 02-NOV-2007 was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (Lot #658449/0989U). Concomitant therapy included ZOLOFT and influenza virus vaccine (unspecified). On 03-NOV-2007 (14 to 15 hours after the injection), the patient developed chills, fever of 102F, and local induration at the site of injection. The patient was instructed to take TYLENOL and apply a topical steroid cream to the area. Within 48 hours the area increased in size from about 4 by 6 inches to 6 by 8 inches. The patient was examined by the physician on 05-NOV-2007. The patient's white blood cell count was 20,000 cells per cubic millimeter of blood. The patient was started on clindamycin. On 06-NOV-2007, the patient was admitted in the hospital and started on IV vancomycin. As of 07-NOV-2007, the patient does not have a fever and her WBC is 11,000 cells per cubic millimeter of blood. She has been examined by an infectious disease physician and a surgeon. The patient is scheduled for an MRI to rule out an abscess. The physician requested a lot check. Additional information has been requested.				Y	Y				N	11/02/2007	11/03/2007	1	complete blood cell - WBC=20,000 cells per cubic millimeter; blood culture - negative	OTH	OTH	ZOLOFT	Penicillin allergy; Allergic reaction to antibiotics	Breast cancer		WAES0711USA01746	1						1	Blood culture negative; Chills; Injection site induration; Pyrexia; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0989U~1~SC~~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0324415	08/06/2008	CO	42.0	42		F	07/30/2008	Information has been received from a registered nurse concerning a 42 (also reported as 32) year old female patient with a history of poor health on 25-OCT-2007 was vaccinated IM into the right deltoid, into her right arm with a first 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (lot# 657038/0860U). Concomitant therapy given into left arm included a first dose of FLUZONE. Other concomitant therapy included PROZAC, WELLBUTRIN XL 300, (TRAZADONE) 100, TOPMAX 25 AND ZOVIRAX 400 mg. It was reported that initially there was no reaction. On 25-OCT-2007, 12 hours post vaccination, the patient developed pain, expanding redness consistent with right shoulder cellulitis. The patient was treated for 7 days with dicloxacillin and doxycycline. The nurse did not feel that this was an inflammatory reaction. At the time of this report, the patient was recovering. No product quality complaint was involved. Right shoulder cellulitis was considered to be another important medical event. This is an amended report. Concomitant therapy FLUZONE is not a suspect medication. Additional information has been requested.				Y					N	10/25/2007	10/25/2007	0	Unknown	OTH	OTH	(therapy unspecified); ZOVIRAX mg; WELLBURTIN XL; PROZAC mg; TOPAMAX		General symptom		WAES0711USA01330	1						1	Cellulitis; Erythema; Pain	FLU3~SANOFI PASTEUR~U2443AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~08860U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0324419	08/06/2008	CO	59.0	59		F	07/30/2008	Information has been received from a registered nurse concerning a 59 year old white female professor with an allergy to vancomycin (hives) and erythromycin (nausea) and no medical history who on 11-OCT-2007, was vaccinated IM into right deltoid with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included influenza virus whole virion 3v vaccine inactivated (FLUZONE (influenza virus whole virion 3v vaccine inactivated)) (lot # U2443AA) administered IM into left arm, levothyroxine Na (SYNTHROID) and bupropion SR 150. On 11-OCT-2007, the patient developed cellulitis in the right shoulder at the injection site with erythema and tenderness 2 inches around the injection site. It was reported that the patient required 2 different antibiotics, cephalexin (KEFLEX) 500 mg QID and amoxicillin (+) clavulanate potassium (AUGMENTION) 875 mg BID. It was reported that she was not treated with medication. Subsequently, the patient was recovering. No product quality complaint was involved. Injection site cellulitis was considered to be life threatening and an other important medical event. Additional information is not expected.			Y	Y					N	10/11/2007	10/11/2007	0	Unknown	PVT	PVT	bupropion hydrochloride - 150 - mg, SYNTHROID	Allergic reaction to antibiotics			WAES0710USA06274	1						1	Injection site cellulitis; Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U2443AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening	Influenza
0324427	08/06/2008	CA				M	07/30/2008	Information has been received from a physician concerning a male who around October, November or December 2007 was vaccinated in the arm with a 1st dose of pneumococcal 23v polysaccharide vaccine (lot# not reported). Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unknown) administered in the same arm. Subsequently the patient experienced severe body aches and pain after receiving his vaccinations. The patient outcome was not reported. The patient sought unspecified medical attention. Additional information has been requested.									U				Unknown	OTH	OTH			Unknown		WAES0803USA03672	1						1	Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0321722	08/11/2008	TN	0.5	0	.5	F	08/08/2008	Information has been received from a physician and a nurse concerning a 10 month old female who on 19-JUN-2007 was vaccinated with a first dose of ROTATEQ oral.  On 07-AUG-2007 the patient was vaccinated with a second dose of ROTATEQ (lot# 657515/0668U) oral.  On 05-OCT-2007 the patient was vaccinated with a third dose of ROTATEQ (lot# 657045/1053U) oral.  Concomitant therapy on 05-OCT-2007 included PREVNAR and PEDIARIX.  On 20-FEB-2008 the patient experienced vomiting and diarrhea.  The patient was taken to the hospital and was diagnosed with intussusception.  A CT scan was performed with no result provided.  The patient was then airlifted to a different hospital.  When the patient got to that hospital the intussusception was gone.  Intussusception was considered to be disabling and immediately life-threatening.  Additional information has been requested.  8/19/08 Reviewed hospital medical records of 2/21/2008. FINAL DX:  gastroenteritis; IS spontaneously resolved Records reveal patient had been transferred via helicopter from outlying ER with diagnosis of intussusception. Patient had experienced abdominal pain x 2 days w/nausea, vomiting, copious watery diarrhea, decreased urine output & irritability.  In outlying ER had abdominal distention.  CT scan done which was c/w IS & transferred to higher level of care.  Surgical consult done.  Tolerated PO fluids in ER & d/c to home.  8/26/08 Reviewed ER medical records of 2/20/2008. FINAL DX: Intussusception Records reveal patient experienced vomiting, diarrhea & reduced oral intake x 2 days.  In ER had fever 101, pulling at ears, behaving abnormally, decreased urine output, no tears w/crying.  Transferred to higher level of care.			Y	Y	Y	1		Y	Y	10/05/2007	02/20/2008	138	Unknown  LABS: CT abdomen/pelvis revealed large bowel gas loops.  Abdominal x-ray.  CBC w/hematocrit 36.6(L) & neutros 22%(L).  CO2 18.7(L), creatinine 0.22(L).  Stool culture neg.  US of abdomen c/w mesenteric adenitis but no IS.	OTH	OTH			Unknown		WAES0807USA05710	1						1	Diarrhoea; Intussusception; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B127A~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2442A~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|RV5~MERCK & CO. INC.~1053U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0321728	08/11/2008	AZ				F	08/07/2008	SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report was received on 28 July 2008 from another manufacturer who received the report from a consumer.  A female patient (age and date of birth not reported) had received an Influenza vaccination six to eight years ago (manufacturer, lot number, route and site of injection not reported), and an unspecified amount of time later she developed a horrible case of pneumonia and almost died.  She was prescribed prednisone and her feet swelled up.  No further information was provided at the time of the report.				Y					U					UNK	UNK					200802443	1						1	Oedema peripheral; Pneumonia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0321729	08/11/2008	CT	49.0	49		F	06/03/2008	Pain, numbness, paresthesias, weakness-hands-also clumsy.  Numbness, paresthesias-legs, lumbar region.  Paresthesias-torso.  Symptoms started approximately one week before flu vaccine.  8/22/08 Reviewed PCP office records which included neuro & ophth consults. FINAL DX: multiple sclerosis, pre-existing, exacerbated by flu shot. Records reveal patient experienced recent mild case of right hip/waist herpes zoster when seen for vax.  Neuro consult done for post vaccinal complaints which began approx 1 wk s/p flu shot.  No reaction to prior flu shots.  Now w/complaints of tingling paresthesias of finger tips & toes, pins & needles of left shoulder, aching pain of left arm & cramping of left fingers, urinary hesitancy, bifrontal dull HA.  Neuro exam on 1/14/08 WNL.  Returned to neuro on 1/23/08 for increased weakness of right hand & prominent paresthesias of chest & abd.  Neuro exam remained WNL but referred for spinal cord MRI, LP & EMG/NCV of LE's.  Returned to neuro 2/6/2008 & tx w/IV steroids x 3 days.  Also referred to neuro-ophthalmic & seen 3/20/2008 where exam was WNL.				Y				Y	U	12/28/2007	01/05/2008	8	MRI of brain and spinal cord revealed non-specific demyelination; EMG/NCS revealed mild bilateral sensory median neuropathies  LABS: CBC WNL.  BUN 26 (H).  cholesterol 217(H).  LDL 134(H).  Brain MRI abnormal revealing multi small hyperintense non-enhancing lesions throughout periventricular & subcortical white matter.  Spinal cord MRI abnormal revealing hyperintense signal abnormalities at C6 & T4 levels.  EMG/NCV abnormal revealing mild bilateral sensory median neuropathies.	PVT	OTH	aspirin 81 mg po qd	None	Healthy individual  PMH: antibiotic induced colitis.  allergic cipro & codeine.			1						1	Clumsiness; Demyelination; Electromyogram abnormal; Hypoaesthesia; Muscular weakness; Nerve conduction studies abnormal; Nuclear magnetic resonance imaging brain abnormal; Pain; Peripheral sensory neuropathy	FLU3~SANOFI PASTEUR~69423~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0321798	08/11/2008	VA	19.0	19		F	07/16/2008	Married 10/13/07.  11/5/07 menstrual cycle 3-4 days vs 5-6 but has irregular cycles since off BCP x several months.  AVA vaccine #1 9/7/07 with 2nd about 2 wks later (estimated 9/21/07 as not in DEERS).  Third AVA, primary ACAM SMPX, flumist given 11/7/07.  No adverse events and normal take for SMPX with foreation at left arm site.  Missed menstrual cycle in Dec with pregnancy test positive 12/20/07.  Normal pregnancy w/o complications, normal vag delivery.  Healthy newborn female born 7/15/08 - needs trensturn released, scheduled for 7/17/08.										11/07/2007	12/20/2007	43	4/3/08 consistent with gestational dating (26 + 1 weeks), no structural anomalies and no soft markers for fetus aneuploidy.	UNK	UNK	None	None	None - 07/16/2008 normal pregnancy (resolved)			1						1	Drug exposure during pregnancy; Pregnancy test positive; Ultrasound scan normal	ANTH~UNKNOWN MANUFACTURER~~UNK~SC~UN~ANTHRAX (NO BRAND NAME)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~UNKNOWN MANUFACTURER~~UNK~~UN~SMALLPOX (NO BRAND NAME)~1	USA		Influenza
0321919	08/12/2008	FL	10.0	10		F	08/12/2008	IMMUNIZATIONS WERE GIVEN ABOUT 15 SECONDS APART IN THIS ORDER, VARICELLA, HAPATITIS A, FLUMIST. THE INJECTIONS WERE GIVEN IN THE LEFT DELTOID (HEPATITIS A) AND SUBCUTANEOUSLY NEAR LEFT DELTOID (VARICELLA). THIS IS THE PATIENTS SECOND DOSE OF BOTH INJECTIONS. THE FLUMIST WAS GIVEN INTRANASALLY. APPROX. 5 MIN AFTER IMMUNIZATIONS WERE GIVEN, THE PATIENT STOOD UP AND WALKED A FEW FEET BEFORE SAYING SHE FELT DIZZY AND SLUMPING TOWARD HER MOTHER. PT WAS CARRIED BACK TO THE EXAM TABLE BY HER MOTHER AND I. PT REMAINED CONCIOUS AND BREATHING, PT DID EXPERIENCE PALLOR AND NAUSEA AND WAS ABLE TO SIT UP AFTER ABOUT 20 SECONDS. PT WAS GIVEN A DRINK AND BP WAS 100/60 @ THIS TIME. PT WAS ALERT AND ORIENTED X3. PT AND MOTHER WERE ASKED TO STAY FOR OBSERVATION FOR ANOTHER 15 MIN AND THEY AGREED. PT LEFT IN NO APPARRENT DISTRESS OR DISCOMFORT.									Y	08/12/2008	08/12/2008	0		PVT	PVT						1						1	Dizziness; Nausea; Pallor	FLUN3~MEDIMMUNE VACCINES, INC.~500541P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB289BA~2~IM~LA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~0102X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0322081	08/13/2008		66.0			F	08/13/2008	This case was reported in a literature article and described the occurrence of miller fisher syndrome in a 66-year-old female subject who was vaccinated with influenza vaccine (Flu vaccine, manufacturer unspecified), and PNEUMOVAX. The subject's medical conditions included no viral type illness. The subject was fully independent with the activities of daily living as well as ambulatory. She had no medical limitations. In October 2007 one week prior to the symptoms the subject received unspecified dose of Flu vaccine (unknown), unspecified dose of PNEUMOVAX (unknown). On 21 October 2007 the subject went to hospital after progressively worsening neurological complaints. One week or so before admission she experienced headache, soon associated with some numbness and tingling in hands and feet, and later associated with dysarthria and swallowing difficulties. The subject was evaluated by neurology with multiple tests. Magnetic resonance imaging and magnetic resonance scan demonstrated no significant abnormality that could have caused her symptoms. With the subject's history, physical and diagnostic testing done noted stability in her course, no worsening but have not much improvement either. She felt somewhat weaker on her left versus the right, but noted significant difficulties with coordinating her movements. She also had residual numbness and tingling involving her face, the inside of her mouth the lower extremities in a knee sock type distribution and in a glove distribution in her upper limbs. She admitted to facial weakness with some dysarthria. However she noted improvement in her face and in her speaking. The subject experienced some intermittent bouts of pain. She had pain in her limbs, particularly in legs described as a combination of burning pain, cramping and irritating numbness and tingling. The subject was treated with gabapentin. She also developed spells where she experienced an autonomic instability giving her 3-10 min period of dizziness, change in vision, headache and hypotension. On physical examination the subject had difficulty in her feet with digit identification as well as proprioception, which was absent at her toes. Light touch sensation was decreased beginning at about the mid thigh level and gradually worsening down to her toes. Upper extremity sensation was not as markedly decreased as in her feet but there was decreased light touch sensation in bilateral hands as well as decreased vibratory sensation. Myoclonus was present bilaterally in both lower extremities Rotational dystonia was present in her ankles, more pronounced on her left side. Digit identification was intact in her hands. With manual muscle testing in general she had 4.5 strength in her limbs with hand intrinsics being weaker, but she was able to give some minimal resistance with intrinsic testing. Reflexes were obtained at her ankle, 1+ at the knee and 1+ in her upper extremities. Extraocular movements were intact. No nystagmus was noted. Mild facial weakness was noted bilaterally. Her speech was mildly dysarthric. There was significant ataxia with attempts at gross as well as fine motor movements, more pronounced in the lower extremities versus the upper extremities. At the time of reporting the outcome of the events was unspecified. The author considered the subject's risk factor that was believed to have led to her disease was the Flu vaccine and/or PNEUMOVAX vaccination a week prior to the symptoms.					Y				U	10/01/2007	10/01/2007	0	MRI angiography, normal; Nuclear magnetic resonance imaging, normal	OTH	OTH		Unknown			B0532712A	1						1	Angiogram normal; Ataxia; Blood product transfusion; Burning sensation; Coordination abnormal; Dizziness; Dysarthria; Dysphagia; Dystonia; Headache; Hemiparesis; Hypoaesthesia; Hypotension; Loss of proprioception; Miller Fisher syndrome; Muscle spasms; Myoclonus; Neurological symptom; Nuclear magnetic resonance imaging normal; Pain in extremity; Pallanaesthesia; Paraesthesia; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0322111	08/13/2008	WA	51.0	51		F	01/09/2008	R arm hot & swollen down to elbow & around.  Painful to both sides of site.  Back aches & spasms, neck pain.  Getting better little less painful.									N	01/08/2008	01/08/2008	0	Having muscular skeletal problems	PVT	UNK	XANAX, RITALIN, ZOLOFT, albuterol, antihist	Depression	Ibuprofen, eggs-scrambled in mixes			1						1	Back pain; Injection site pain; Injection site swelling; Injection site warmth; Muscle spasms; Neck pain	FLUX~UNKNOWN MANUFACTURER~~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~UN~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0322122	08/13/2008	MI				M		States has a persistent cough since he received the flu shot on 12/11/07.									U	12/11/2007				PVT	PVT	VIAGRA, ZETIA, DYAZIDE, folic acid	None				1						1	Cough	FLU3~SANOFI PASTEUR~V2523AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0322220	08/14/2008	OK	42.0	42		M	08/14/2008	Headache, joint pain, arthritis, fibromyalgia, skin rashes and lesions, chronic fatigue, insomnia, severe pain, diminished vision, feeling like body being crushed, diarrhea, vomiting, extremes in weight gain and loss, unexplained rash, chest pain, shortness of breath, walk with a cane, mouth sores, memory loss, muscle cramps, just to list some of them.			Y	Y	Y	8	Y	Y	N	06/20/2003	09/01/2003	73	Too numerous to name but most done by hospital.	MIL	MIL	anti-inflammatory, pain medicine, mvi	Recovering from multiple orthopedic surgeries.	None other than surgeries mentioned in 18.	sharp decline in general health~Anthrax (no brand name)~4~42.30~Patient		1						1	Amnesia; Arthralgia; Arthritis; Chest pain; Diarrhoea; Dyspnoea; Fatigue; Feeling abnormal; Fibromyalgia; Headache; Insomnia; Muscle spasms; Pain; Rash; Skin lesion; Stomatitis; Visual acuity reduced; Vomiting; Walking aid user; Weight fluctuation	ANTH~UNKNOWN MANUFACTURER~unkown~4~IM~RA~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0300477	08/15/2008		4.0			M		A non-serious spontaneous report of bronchitis and pneumonia was received from a parent concerning a four-year-old male. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The child's medical history included cold, seasonal allergy, postnasal drip, atopic, and peanut allergy. No concomitant medication was reported. The patient received FluMist on 03Nov2007. On 07Nov2007, a parent that her son was diagnosed with bronchitis/early pneumonia four days following FluMist vaccination. The child had sniffles the day of vaccination. The mother states that it was difficult to tease apart her son's colds from his seasonal allergies and postnasal drips. The child was started on a Z-pack. The patient was recovering. The causality was not reported. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U	11/03/2007	11/03/2007	0		OTH	OTH	Concomitant Drug(s) Not Reported	Postnasal	No previous asthma or wheezing		MEDI0006157	1						2	Bronchitis; Pneumonia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0309594	08/15/2008	CO	6.0			F	09/09/2008	A serious spontaneous report of LEIGH'S ENCEPHALOPATHY SYNDROME, brain inflammation, sepsis, respiratory failure, gasping respirations, unresponsiveness, swallowing problems, staring, multiple episodes of falling, photophobia, disorientation, unsteady gait, brisk deep tender reflexes, fatigue, ataxia, expired drug administered, general weakness, appears sleepy and fever has been received from a health authority concerning a six-year-old female, subsequent to FLUMIST. The patient's past medical history includes premature birth at 29 weeks gestation; mechanical ventilation due to pneumonia; a long history of mild developmental delays; gait disturbance; strabismus repair, PE tubes; adenoidectomy; rotavirus; did not receive her five-year-old vaccinations; she was weak prior to vaccination; and two months of respiratory problems at night when asleep described as sudden inspiratory gasp. The patient's maternal family history included migraines, fibromyalgia, elevated ANA and congenital lactic acidosis. Concomitant medications have not been reported. The patient received the first and only dose of FLUMIST on 11-Jan-2006. Approximately seven to ten days later, the patient became weak with multiple episodes of falling to the ground, difficulty walking, ataxia, progress weakness leading to breathing and swallowing problems. On 28-Jan-2008, the patient was seen in the emergency room for photophobia and disorientation. Physical exam, laboratory studies and EES were all normal. One week later, the patient was seen at a neurology clinic, and a physical examination showed unsteady gait, brisk deep tendon reflexes, and general weakness. The patient was also experiencing difficulties with breathing and swallowing; gasping-like breathing pattern especially during sleep. On 11-Feb-2008, a cranial MRI showed abnormal basal ganglia, bilateral intensities in the anterior globus pallidus and sparing of caudate and thalamus, which were suggestive of LEIGH'S DISEASE. Serum lactate was mildly elevated at 3.8 mmol/L. On 21-Feb-2008, the patient was referred to a metabolic clinic for evaluation of possible mitochondrial disease based on clinical findings, mildly elevated serum lactate, abnormal cranial MRI and suggestive family history. The patient was worked up for LEIGH'S DISEASE and mitochondrial disease after getting consent from the family. On an unreported date, the patient was diagnosed with a genetic mitochondrial mutation 8993T-C for mitochondrial disease. The patient was reported to be weak prior to vaccination, but more so after vaccination and was receiving physical and occupational therapy. The patient was noted to have staring episodes usually at night, became more limp, appeared sleepy, acted as if he was drunk and became unresponsive. No tonic clonic seizure activity was reported. On 15-Mar-2008, the patient was then transported to the emergency via EMS due to gasping respirations and unresponsiveness. The patient was then transferred to another hospital for admission, observation during sleep, and continued care by a neurologist. A sleep study was done on 19-Mar-2008 showed hyperventilation and obstructive sleep apnea. The diagnosis for this hospitalization included LEIGH'S ENCEPHALOPAHY SYNDROME, respiratory failure and sepsis. On an unreported date, the patient underwent an unspecified surgery, after which she remained on a mechanical ventilation and required continuous positive airway pressure. The patient's neurologic status became more obtunded and she was unresponsive. The patient also experienced fevers secondary to brain inflammation due to LEIGH'S SYNDROME. On 05-Apr-2008, the patient was withdrawn from life support and died. The sponsor considered the LEIGH'S DISEASE an important medical event.	Y				Y				N	01/11/2008	01/11/2008	0	11-Feb-2008 Cranial MRI: genetic mutation 8993 T-C for mitochondrial disease; bilateral intensities in the anterior globus pallidus and sparing of caudate and thalamus, suggestive of LEIGH'S DISEASE: abnormal basal ganglia 19-Mar-2008 Sleep study: hyperventilation and obstructive sleep apnea; 21-MAR-2008 G-Tube insertion; EEG 01/28/08 Negative; Serum Lactate 3.8 mmol/L, mildly elevated	OTH	OTH	Concomitant Drug (s) Not Reported	Gait disturbance; Developmental delay; Strabismus	Born at 29 weeks gestation; on ventilator due to pneumonia;  Hospitalized for three months; Status post strabismus repair, PE tube insertion and adenoidectomy; Did not receive five-year-old vaccinations; Was weak prior to vaccination; Two months of respiratory problems at night when asleep described as sudden inspiratory gasp; Maternal family history included migraine, fibromyalgia, elevated ANA and congenital lactic acidosis; Prematurity; Ear tube insertion; Adenoidectomy; Rotavirus gastroenteritis; Pneumonia; Mechanical ventilation		MEDI0006754	1						2	Asthenia; Ataxia; Congenital anomaly; Dyspnoea; Expired drug administered; Fall; Gait disturbance; Gene mutation identification test; Mitochondrial encephalomyopathy; Nuclear magnetic resonance imaging abnormal; Asthenia; Ataxia; Blood lactic acid increased; Continuous positive airway pressure; Death; Depressed level of consciousness; Disorientation; Dysphagia; Dyspnoea; Electroencephalogram normal; Encephalitis; Expired drug administered; Fall; Fatigue; Gait disturbance; Gastrointestinal tube insertion; Hyperreflexia; Hyperventilation; Inflammation; Mechanical ventilation; Mitochondrial cytopathy; Mitochondrial encephalomyopathy; Nuclear magnetic resonance imaging brain abnormal; Photophobia; Pyrexia; Respiratory failure; Sepsis; Sleep apnoea syndrome; Sleep study abnormal; Somnolence; Staring; Unresponsive to stimuli	FLUN3~MEDIMMUNE VACCINES, INC.~500490P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~In5C0490P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Results in Death	Influenza
0322329	08/15/2008	CA	19.0	19		F	08/15/2008	Client developed redness, tenderness, swelling approximately 2-3 hours after administration of the Pneumovax and Fluviron vaccines. Is currently taking clindamycin to treat cellulitis.				Y					N	08/12/2008	08/12/2008	0	None	PUB	PUB	Clindamycin	tumor on pancreas	Von Willenbrandt disorder (mild)	flu-like symptoms~Hep A (no brand name)~~0.00~In Patient		1						1	Cellulitis; Erythema; Swelling; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~U2742AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0733U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0324433	08/15/2008	CA	39.0	39		F	06/27/2007	MEDI-0004973 is a Not Serious Spontaneous case from a Consumer involving VACCINE EXPOSURE DURING PREGNANCY: (Unlabelled). The reporter causality is Possible to FluMist. A 39-year-old female who is 14-weeks pregnant (obtained via ultrasound) received FluMist on 28-Sep-2006 from her child's pediatrician. A few hours after receiving the vaccine, the patient developed mild sore throat, mild headache and mild fatigue. There were no changes in symptom intensity and the symptoms dissipated on their own without any medical interventions. Sore throat was fully resolved on 30 Sep-2006. Headache and fatigue completed dissipated on 02-Oct-2006. After receiving the vaccine, the patient was told by her obstetrician that a pregnant woman should not be receiving FluMist* vaccine. After hearing this statement and reading up on FluMist, patient became quite concerned and became very anxious. Patient attributed developing anxiety to worrying about the possible effect FluMist may have on my (unborn) baby. This patient was G4P2 with a history of one elective abortion in April, 2006 for Down Syndrome. Her last menstrual period was 21-Jun-2006 and her estimated date of delivery was 30-Mar-2007. The patient denied having any history of medical problems. She denied taking any medications (prescribed and over the counter) during her pregnancy. The patient stated her anxiety persisted throughout her pregnancy. Her anxiety resolved after she delivered a healthy baby boy via scheduled caesarian-section on 21-Mar-2007. She stated that there were no complications during her pregnancy or during the birth of her baby. The baby is doing well. The reporter causality is possible to FluMist. 27-Jun-2007: Follow up information obtained and incorporated in above narrative: information regarding clinical outcome.									Y	09/28/2006	09/28/2006	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0004973	1						1	Anxiety; Caesarean section; Drug exposure during pregnancy; Fatigue; Headache; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324434	08/15/2008	TN	5.0			F		A non-serious report of high fever, sore throat, and coughing has been received from a consumer concerning a five-year-old female patient. At the time of this report, medical history or concomitant medications were provided. The patient received FluMist on an unknown date. One to two days after the patient received FluMist, the patient developed a high fever, sore throat, and coughing. No outcome for the events was provided by the reporter. The reporter provided no causality assessment for the events. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U					UNK	UNK	Concomitant Drug(s) Not Reported				MEDI0006010	1						1	Cough; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324435	08/15/2008	CA	49.0	49		F		An event of expired vaccine administered occurred in a 49-year-old female. The report was received from a registered nurse. No medical or drug history information has been reported for this patient. The patient received a 1.05 ml dose of FLUMIST intranasally on 08-Oct-2007. On 08-Oct-2007 the reporter indicated a patient was inadvertently administered FLUMIST that had expired in Feb-2007. The reporter indicated the package was clearly labeled. The expired FLUMIST had been kept in the freezer in order to compare it with new vials received this season for changes. The error was discovered approximately 10 minutes after administering the dose. The reporter considered the patient about 20 minutes after dosing and the patient stated she was fine. No adverse events were observed. Outcome: the patient had no ill effects. Further dosing with FLUMIST is not indicated. The reporter did not provide a causality assessment for this medication error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	10/08/2007	10/08/2007	0		PVT	PVT					MEDI0006034	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~5D0436P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324436	08/15/2008					F	10/11/2007	A non-serious report of accidental exposure, numbness and itching has been received from a nurse concerning a female born 27-Mar-1965.  No medical history nor concomitant medications were provided.  The patient administered FLUMIST in a clinic setting.  The employee of a clinic, develops numbness in her lips and nose, as well as itching of her face and scalp within several minutes of administering a dose of FLUMIST to a patient.  The employee was able to administer doses last year without difficulty.  Symptoms resolved 15 to 20 minutes after dose administration is completed.  The patient did not experience a rechallenge while receiving the suspect product.  The reporter provided no causality assessment for the events.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y		10/04/2007			UNK	UNK	Concomitant drug(s) not reported				MEDI0006059	1						1	Accidental exposure; Hypoaesthesia; Pruritus	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324437	08/15/2008	WI	46.0			U		An event of entire dosage of FluMist in the same nostril occurred in a 46 year-old employee; the report was received from a registered nurse. No medical history or drug history information has been reported for this employee. The employee received FluMist intranasally. The reporter indicated the employee was inadvertently administered the entire dosage of FluMist in the same nostril; this is not in accordance with FluMist dosage and administration requirements. No adverse events were reported. Outcome the employee had no ill effects. Further dosing with FluMist is not indicated. The reporter did not provide a causality assessment for this medication error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y					PVT	PVT	Concomitant Drug(s) Not reported				MEDI0006065	1						1	No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324438	08/15/2008	WI	34.0			U		An event of entire dosage of FLUMIST in the same nostril occurred in a 34-year-old patient: the report was received from a registered nurse. No medical history or drug history information has been reported for this employee. The patient received FLUMIST intranasally. The reporter indicated the patient was inadvertently administered the entire dosage of FLUMIST in the same nostril, this is not in accordance with FLUMIST dosage and administration requirements. No adverse events were reported. Outcome: the patient had no ill effects. Further dosing with FLUMIST is not indicated. The reporter did not provide a causality assessment for this drug administration error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable									Y					PVT	PVT					MEDI0006066	1						1	No adverse event; Wrong technique in drug usage process	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324546	08/15/2008	GA	6.0	6		F		A non-serious report of flu-like symptoms was received from a physician concerning a seven-year-old female.  No relevant medical or drug history was reported for this patient.  The patient received FLUMIST on 08-Oct-2007.  One day after receiving FLUMIST, the patient experienced flu-like symptoms of high fever, headache and runny nose.  Outcome of the event was not reported.  Rechallenge of vaccine is not applicable.  The reporting physician did not provide a causality assessment.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow up received on 14-Nov-2008 adds patient information including the date of birth. The reporting physician is no longer associated with this site and the patient no longer comes to his office for medical care. The site therefore had no chart for the patient and was unable to provide FLUMIST dosing information. No further information is availalbe for this patient.									U	10/08/2007	10/09/2007	1		PVT	OTH	Concomitant drug(s) not reported				MEDI0006067	1						1	Headache; Influenza like illness; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324547	08/15/2008	GA	40.0			F		A spontaneous non-serious report of facial numbness has been received from a nurse concerning a 40-year-old female. No relevant medical or drug history information has been reported for this patient. The patient received the initial dose of FLUMIST on an unknown date. On an unknown date in October 2007, the patient reported numbness of the left side of the face 45 minutes to an hour following administration of FLUMIST into each nostril to a healthcare provider (nurse). The numbness was described as milder than Novocaine occurring below the patient's left eye to the margin to the lips. The numbness was without edema or any other side effects. On 15Oct2007, the reporting healthcare provider (nurse) contacted the sponsor's medical information department to discuss numbness after receiving FLUMIST. The outcome was not reported. The reporter did not provide a causality assessment for the adverse event reported. The MedImmune Product Safety Physician conservatively assessed causality for the event as possibly related to FLUMIST therapy.									U	10/01/2007	10/01/2007	0		OTH	OTH					MEDI0006074	1						1	Hypoaesthesia facial	FLUN3~MEDIMMUNE VACCINES, INC.~500488P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324548	08/15/2008	TN	10.0			M	10/15/2007	A non-serious report of stiff back, stiff neck and fever was received from a consumer concerning a 10-year-old female.  The patient has a cochlear implant.  No concomitant medications were reported.  The patient received FLUMIST vaccine on 03-Oct-2007.  On 05-Oct-2007 the patient experienced fever of up to 103 degrees Fahrenheit, stiff back and stiff neck.  The patient's pediatrician ruled out meningitis.  By 08-Oct-2007, all symptoms have resolved and the patient went to school that day without any problems.  The reporter did not provide a statement of causality for the adverse events.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	10/03/2007	10/05/2007	2		PVT	UNK			Patient has a cochlear implant		MEDI0006075	1						1	Musculoskeletal stiffness; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324549	08/15/2008	FL	11.0			M	10/15/2007	A non-serious spontaneous report was received from a consumer of hives concerning an 11-year-old male. No relevant medial and drug history information has been reported for this patient. The patient initiated FluMist therapy on an unreported date in October of 2007. Twenty-fours following administration of FluMist therapy, the patient broke out with hives all over his body required treatment with Benadryl to relieve symptoms. The reporter indicated that the patient did not experience fever or breathing problems. The symptoms persisted 24 to 48 hours. There was no indication of action taken regarding FluMist. The reporter did not provided a causality assessment for the adverse event reported. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y					OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0006077	1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324550	08/15/2008	TX	5.0			M		A non-serious spontaneous report of fever and influenza B was received from a physician concerning a five-year-old male. No relevant medical or drug history information was reported for this patient. The patient received the initial dose of FLUMIST on an unknown date. On 16Oct2007, a physician reported fever (101.5 F) and a positive antigen test for influenza B strain 72 hours following FLUMIST vaccination. After checking the child's temperature, the physician performed a quick antigen test: results positive for influenza B strain but negative for the A strain. The physician conjectured that since the test was negative for any A strain, the infection may not have been caused by the A strain in the vaccine. The child also attends day care. The physician prescribed the child TAMIFLU and notified the sponsor. The outcome was not reported. The physician indicated that the causality was not clear (wild strain vs. B strain). The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U	10/01/2007	10/07/2007	6		PVT	OTH			Patient attends day care		MEDI0006089	1						1	Influenza; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324551	08/15/2008	CO				M		A spontaneous report of INFLUENZA has been received from a parent concerning a teenaged male.  No relevant medical or drug history information has been reported for this patient.  The patient received the initial dose of FLUMIST on an unknown date.  The reporter states that he took both of his teenagers to a pediatric practice that specifically had Flumist.  On 23Oct2007, the father reported a serious case of the flu in his teenage son, one week after receiving Flumist.  The outcome was not reported.  The reporter did not provide a causality assessment for the adverse event reported.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U	10/16/2007	10/23/2007	7		PVT	OTH	Concomitant drug(s) not reported				MEDI0006104	1						1	Influenza	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324552	08/15/2008	NY	34.0			U		A spontaneous report of inadvertent use of expired FluMist was received from a nurse concerning a 34-year-old adult. No relevant medical or drug history information was reported for this patient. The patient received the initial dose of FluMist on an unknown date. On 26Oct2007, a nurse reported the inadvertent use of expired FluMist vaccine in an adult. No adverse event was reported. The patient is being considered for re-immunization. The reporter did not provided a causality assessment for the adverse event reported. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y					PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0006113	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324553	08/15/2008	CO	85.0			F		An event of drug administration error when vaccine was administered to an 85-year-old female. The report was received from a registered nurse. No medical or drug history information has been reported for this patient. The woman received a dose of FLUMIST intranasally. On 15-Oct-2007 the reporter indicated an elderly woman was inadvertently administered FLUMIST. The reporter indicated the nurse who dosed the woman was new and not aware of the age restriction for dosing FLUMIST. The reporter stated no adverse events were observed. Outcome: the woman had no ill effects. Further dosing with FLUMIST is not indicated. The reporter did not provide a causality assessment for this medication error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable									Y	10/15/2007				PVT	UNK					MEDI0006114	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500486P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324554	08/15/2008	LA	7.0	7		M	10/26/2007	MEDI-000610 is a non-serious spontaneous case from a nurse of itching and facial rash concerning a six-year-old male.  The patient has a medical history of behavioral issues and Asperger's Disease.  Concomitant medications include Abilify and Depakote.  The patient received intranasal Flumist on 25 Oct 2007.  Less than 24 hours after administration of Flumist, the patient developed a red facial rash with itching.  The reporter indicated that the patient telephoned the reaction to the clinic, however the patient was not brought to the clinic and was not medically evaluated by the pediatrician.  The reporter indicated that no further information will be available.  Outcome for the events was not reported.  There was no indication of action taken with Flumist.  The reporter did not provide a causality assessment for the adverse events.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U	10/25/2007	10/25/2007	0		PVT	UNK	Abilify, Depakote	Behavior disorder; Asperger's disorder.			MEDI0006120	1						1	Pruritus; Rash; Rash erythematous	FLUN3~MEDIMMUNE VACCINES, INC.~500489P~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324555	08/15/2008	TX	9.0	9		M		A non-serious spontaneous report of facial edema was received from a nurse concerning a nine-year old male. The patient's medical history was not reported. The child also received VARIVAX simultaneously with FluMist. The patient received on 30-Oct-2007. Four after receiving both FluMist and VARIVAX, the child developed facial edema, mottling with redness on face, red and purple hue of the face, coughing, and expiratory wheezing. The child was taken to the emergency room was not hospitalized. The symptoms resolved the following day. Action taken regarding FluMist was not reported. The reporter's assessment of causality was not provided. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	10/30/2007	10/30/2007	0		OTH	OTH	Concomitant drug9s) Not Reported				MEDI0006128	1						1	Cough; Erythema; Face oedema; Livedo reticularis; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500467P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~~UNK~UN~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0324556	08/15/2008		37.0	37		M	10/19/2007	A non-serious report was received from a consumer of feeling sick concerning a 38-year-old male.  No medical history or concomitant medications were reported for this patient.  The patient initiated FLUMIST on an unreported date.  The patient felt sick following FLUMIST vaccine administration.  No further information was provided. Outcome for the adverse event was not reported.  The reporter did not provide a causality assessment for the adverse event reported.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	10/01/2007	10/01/2007	0		MIL	PUB	Concomitant Drug(s) Not Reported				MEDI0006147	1						1	Malaise	FLUN3~MEDIMMUNE VACCINES, INC.~~1~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324557	08/15/2008		38.0	38		F		Vaccine exposure during pregnancy (Drug exposure during pregnancy); A non-serious report of vaccine exposure during pregnancy has been received from a nurse concerning a 38-year-old female. No medical history nor concomitant medications were provided. The patient received FluMist on 06-Nov-2007. The patient was pregnant at the time that FluMist was administered. No outcome for the event was provided by the reporter. Dechallenge and rechallenge did not occur. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U	11/06/2007	11/06/2007	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0006150	1						1	Drug exposure during pregnancy	FLUN3~MEDIMMUNE VACCINES, INC.~500492P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324558	08/15/2008	WA				M	11/08/2007	A non-serious report of full dosage of vaccine delivered up one nostril was received from a consumer concerning a male patient.  The patient's medical history and concomitant medications were not reported.  The patient received FLUMIST vaccine intranasally on 08-Nov-2007.  The patient inadvertently received the full dosage of the FLUMIST vaccine up on one nostril, instead of the recommended half dose for each nostril.  No adverse event was reported.  No outcome was provided by the reporter.  Rechallange is not applicable.  The reporter did not provide a statement of causality.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	11/08/2007	11/08/2007	0		UNK	UNK	Concomitant Drug(s) Not Reported				MEDI0006155	1						1	No adverse event; Wrong technique in drug usage process	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324559	08/15/2008	DE	40.0	40		F	11/08/2007	A non-serious spontaneous case was received from a consumer involving flu and sore throat concerning a 40-year-old female.  No relevant medical or drug history information was reported.  The patient received FLUMIST on 06-Nov-2007.  The patient woke-up the following day with the flu and sore throat.  No outcome for the event was provided by the reporter.  The reporter provided no causality assessment for the events.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U	11/07/2007	11/07/2007	0		UNK	UNK	Concomitant Drug(s) Not Reported				MEDI0006171	1						1	Influenza; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324560	08/15/2008	DE	6.0	6		M	11/08/2007	A non-serious spontaneous case was received from a consumer involving flu, sore throat, high fever, lethargy, and loss of appetite concerning a six-year-old male.  No relevant medical or drug history information was reported.  The patient received FluMist on 06-Nov-2007.  The patient woke up on the following day with influenza, sore throat, high fever, lethargy, and loss of appetite.  No outcome for the events was provided by the reporter.  The reporter provided no causality assessment for the events.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U	11/06/2007	11/07/2007	1		UNK	UNK	Concomitant drug(s) not reported				MEDI0006172	1						1	Anorexia; Influenza; Lethargy; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324561	08/15/2008	MD	5.0	5		M		A non-serious spontaneous report of FLUMIST INADVERTENTLY ADMINISTERED TO AN ASTHMATIC was received from a nurse concerning a five-year-old male. The patient's medical history included asthma. Drug history information included previous injectable dose of a flu vaccine in the previous month. The patient received FLUMIST on 08Nov2007. On 03Oct2007, the child received an injectable dose of flu vaccine. On 08Nov2007, the child was inadvertently administered FLUMIST by his school. There were no adverse events reported. The reporter did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	11/08/2007				PUB	OTH		Asthma	Previous administration of vaccine on 03Oct2007		MEDI0006173	1						1	Wrong drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324562	08/15/2008	MA	5.0			M		A non-serious report of a rash that looked like sunburn was received from a nurse concerning a five-year-old male.  No medical history or concomitant medication history were reported.  The patient received FLUMIST on 08Nov2007.  On 09Nov2007, the child experienced a rash that looked like sunburn covering large areas of the body, although specific location was not provided.  No outcome was reported.  No dechallenge or rechallenge occurred.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U	11/08/2007	11/09/2007	1		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0006177	1						1	Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500457F~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324563	08/15/2008	MA	5.0			M	11/09/2007	A non-serious report was received from a nurse concerning a five-year-old male with influenza, fever, headache, sore throat and vomiting. The child had no known allergies and had a flu shot in the past. FluMist was administered on 06-Nov-2007. Two days later on 08-Nov-2007, the child presented with a fever of 102-103, headache, body ache and vomiting. A rapid flu test revealed positive results and a strep test was negative. The nurse wanted to know if FluMist could cause a false positive flu test. The event outcome was not provided. Additional FluMist dosing is not indicated. The reporter did not provide a causality assessment for the adverse events reported. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U	11/06/2007	11/08/2007	2	RAPID FLU TEST, 11/08/07, positive; STREP TEST, 11/08/07, negative	PVT	OTH	Concomitant Drug(s) Not Reported		NKA.  Had flu shot in the past.		MEDI0006178	1						1	Headache; Influenza; Influenza serology positive; Pain; Pharyngolaryngeal pain; Pyrexia; Streptococcal identification test negative; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~5004878P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324564	08/15/2008	VA	8.0	8		M		A non-serious spontaneous case of body ache, fever and malaise has been received from a physician in an eight-year-old male. No medical history or drug history information has been reported for this child. The child received FluMist on 28-Oct-2007. The child's mother, a physician, who reported this case indicated the child received FluMist and within five hours experienced body aches, fever with a temperature of 103, and malaise. His mother indicated that after 12 to 24 hours, the symptoms resolved and no other problems were noted. The adverse events resolved within 24 hours. The child has been dosed with FluMist in the last four seasons, the reporter stated she did not remember the child experiencing adverse events in the past seasons. The child's older brother received FluMist out of the same box as his brother and had no issues. The reporter did not provide a causality assessment for this event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	10/28/2007	10/28/2007	0		PVT	UNK	Concomitant Drug(s) Not Reported				MEDI0006179	1						1	Malaise; Pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500487P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324565	08/15/2008	TX	10.0			F	12/28/2007	A serious medically important event of flattened right facial area with uneven smile, cheek felt heavy, chewing favored on left side, right eye dryness and pain was received from a physician concerning a ten-year-old female. The patient's medical history include a recent treatment with Diflucan for vaginal moniliasis. No concomitant medications were reported. The patient received one dose of FLUMIST intranasally on 06-Nov-2007. On 08-Nov-2007, the patient's father noticed that the patient had an uneven smile; preferred to chew on the left side of her mouth. There was no complaint of pain or difficulty in swallowing. The patient was seen at the reporter's office on the same day. On examination, flattened right facial area was noted along with complaints of right eye felt dry with slight pain and right cheek felt heavy. No redness or swelling noted and patient felt skin touched and pricked. No laboratory tests were done. There was no treatment done except for observation and close contact with patient's father. The events were resolved by 12-Nov-2008. The patient did not experience rechallenge. The reporter did not provide a statement of causality for the events. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	11/06/2007	11/08/2007	2		OTH	OTH					MEDI0006180	1						1	Dry eye; Eye pain; Facial palsy; Hypoaesthesia facial; Mastication disorder	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324566	08/15/2008	MO	27.0			M	11/12/2007	A non-serious report was received from a consumer involving lethargy, sore throat, clogged sinuses and feeling crazy concerning a 27-year-old male. No medical history or concomitant medications were reported for this patient. The patient was administered FLUMIST vaccine on 08 Nov 2007. On 09 Nov 2007, the patient experienced sore throat, clogged sinuses, lethargy and feeling crazy. No information was reported. The events of lethargy and feeling crazy resolved on an unreported date. The events of sore throat and clogged sinuses remain unresolved after three days. Action taken with FLUMIST was not reported. The reporter did not provide a causality assessment for the adverse events reported. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	11/08/2007	11/09/2007	1		OTH	OTH					MEDI0006183	1						1	Feeling abnormal; Lethargy; Pharyngolaryngeal pain; Sinus congestion	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324567	08/15/2008	TX	7.0			M		A non-serious report of hives has been received from a nurse concerning a seven-year-old male. No medical history nor concomitant medications were provided. The patient received FluMist on 08-Nov-2007. In the morning of 09-Nov-2007, the child developed hives and was directed to be taken to the emergency room because the pediatric clinic did not have any appointments available. No outcome for the event was provided by the reporter. No dechallenge or rechallenge occurred. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U	11/08/2007	11/09/2007	1		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI00006187	1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324568	08/15/2008	OH	6.0			F	11/15/2007	A non-serious report of fever, vomiting, and diarrhea has been received from a nurse concerning a six-year-old female.  No medical history nor concomitant medications were provided.  The patient received the initial FluMist dose out of the two dose series, on an unknown date.  Two days after the dose of FluMist, the patient had a low grade fever, vomiting, and diarrhea.  Outcome for the events was not provided by the reporter.  It is unknown whether the patient received the second dose of the two dose series of FluMist.  The reporter provided no causality assessment for the events.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U					OTH	OTH	Concomitant drug(s) not reported				MEDI0006192	1						1	Diarrhoea; Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324569	08/15/2008	AZ	6.0			F	11/16/2007	A nurse reported a non-serious case of vaccination from last year's FluMist involving a six-year-old female. No medical or drug history information has been reported for this patient. The patient received a dose of FluMist on 15-Nov-2007. The nurse reported that a coworker gave last year's FluMist vaccine to the patient. The nurse was familiar with the frozen product and did not noted the vaccine expiration date. The product was hand awaiting return permission from the VFC agency. No ill effects were observed as of 27-Nov-2007. No additional information available. The child was also vaccinated with the 2007-2008 FluMist vaccine on 15-Nov-2007. The reporter did not provide a causality assessment for this medication error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Linked case MDBI-0006197 report for a sibling.									Y	11/15/2007	11/15/2007	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0006196	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500436P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324570	08/15/2008	AZ	9.0			M	11/16/2007	A nurse reported a non-serious case involving giving last years FluMist vaccine to a nine-year-old male.  No medical or drug history information has been reported for this patient.  The patient received a dose of FluMist on 15-Nov-2007.  The nurse reported that a coworker gave last year's FluMist vaccine to the patient.  The nurse was familiar with the frozen product and did not note the vaccine expiration date.  The product was hand awaiting return permission from the VFC agency.  No additional information is available.  No ill effects were observed as of 27-Nov-2007.  The child was also vaccinated with the 2007-2008 vaccine on 15-Nov-2007.  The reporter did not provide a causality assessment for this event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  Linked to MEDI-0006196 reports the six-year-old sibling received last year's vaccine.									Y	11/15/2007	11/15/2007	0		OTH	OTH	Concomitant drug(s) not reported				MEDI0006197	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500436P~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324571	08/15/2008	MD	34.0	34		F	11/16/2007	A non-serious report was received by a pharmaceutical company representative concerning a 34-year-old female. The patient had a history of sinusitis and had been under treatment since 12-Nov-2007. No drug history was reported for this patient. The patient received FLUMIST late on 14-Nov-2007. Within hours she experienced increased sinus, teeth, jaw, eye pain and headache. The teeth, jaw and eye were the most uncomfortable. Outcome for the reported adverse events was not reported. The patient did not experience a rechallenge while receiving the suspect product. The reporter did not provide a causality assessment for the adverse events reported. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U	11/14/2007	11/14/2007	0		OTH	OTH		Sinusitis			MEDI0006199	1						1	Eye pain; Headache; Pain in jaw; Sinus headache; Toothache	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324572	08/15/2008	PA	5.0	5		M		No relevant medical or drug history information was reported.  The patient was given FLUMIST at 10:00AM on 16-Nov-2007.  by 5:00PM on 16-Nov-2007, the patient was throwing up and had a high fever.  Exact temperature was not stated.  Rechallenge is not applicable.  Causality assessment is not applicable.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U	11/16/2007	11/16/2007	0		UNK	UNK	Concomitant Drug(s) Not Reported				MEDI0006202	1						1	Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324573	08/15/2008	MA	63.0	63		M	11/21/2007	A non-serious report was received from a physician of FLUMIST INADVERTENTLY ADMINISTERED involving a 63-year-old male. The patient's medical history includes chronic heart disease. No concomitant medications were reported for this patient. The patient received FluMist on 20 Nov 2007. On 20 Nov 2007, the patient was inadvertently administered FluMist vaccine. FluMist vaccine is approved for patients between 5 and 49 years of age. The reporter indicated that no adverse event occurred as a result of FluMist vaccination. No adverse event was reported. Rechallenge is not applicable. The reporter did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	11/20/2007	11/20/2007	0		PVT	UNK	Concomitant Drug(s) Not Reported	Heart disease, unspecified			MEDI0006216	1						1	Inappropriate schedule of drug administration; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500486P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324574	08/15/2008	KY	9.0	9		M	11/27/2007	A non-serious report of partial dose administered and FLUMIST dripped into patient's mouth was received from a nurse concerning a nine-year old male. No medical or drug history was reported for this patient. The patient received FLUMIST intranasally on 21 Nov 2007. The reporter indicated that while administering FLUMIST the syringe cracked and product inadvertently dripped into the patient's mouth. A partial dose was administered into one nostril. Six days after dosing there were no adverse events reported. The patient had no adverse events. Further dosing with FLUMIST is not indicated. Causality assessment was not reported. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	11/21/2007	11/21/2007	0		PVT	UNK					MEDI0006225	1						1	Incorrect dose administered; Medical device complication; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500492P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324575	08/15/2008	CA	4.0	4		F	11/27/2007	A non-serious spontaneous case of dry throat, nasal congestion and drainage, diarrhea, headache, fever and abdominal pain characterized by cramps, discomfort and fullness has been received from a consumer for a five-year-old female.  No medical history or drug history information has been reported for this child.  The child received FluMist on 21-Nov-2007.  The child's mother who reported this case indicated the child received FluMist and the next day experienced a dry, scratchy throat.  Nasal congestion and drainage developed two to three days post administration.  Around 25-Nov-2007 the child developed diarrhea, stomach discomfort, abdominal cramping and fullness.  She also began complaining of a headache.  A low grade fever of 101 degrees started on 26-Nov-2007.  No outcome has been provided for this event.  Further dosing was not indicated.  The reporter did not provide a causality assessment for this event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. 03-Jul-2008: Follow-up information obtained and incorporated in above narrative information on child's physical condition on the day of FLUMIST administration.									U	11/21/2007	11/22/2007	1		PVT	OTH	Concomitant drug(s) not reported				MEDI0006226	1						1	Abdominal discomfort; Abdominal distension; Abdominal pain; Diarrhoea; Dry throat; Headache; Nasal congestion; Pyrexia; Rhinorrhoea; Throat irritation	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~UNKNOWN MANUFACTURER~~UNK~SC~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~1	USA		Influenza
0324576	08/15/2008	OH				M	12/12/2007	A non-serious event of flu symptoms has been received from a company from a physician concerning a male adult. No medical or drug history was provided for this patient.									Y					OTH	OTH					MEDI0006234	1						1	Influenza	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324577	08/15/2008	IL	33.0			F	12/03/2007	A non-serious report was received from a consumer of fever, bodyaches, sneezing and coughing involving a 33-year-old female. No medical history or concomitant medication was reported for this patient. The patient was administered FluMist on 29 Nov 2007. On 30 Nov 2007, the patient began to experience body-aches. The following day, the patient developed a fever of 103, experienced sneezing, coughing, nasal congestion and continued to have body aches with pain in her neck. The patient indicated that her symptoms felt like a strong flu, however she was not taking medications. Outcome for the reported adverse events was not provided. Action taken with FluMist was not indicated. The reporter did not provide a statement of causality for the adverse events. The reporting source of this is spontaneous, thus the sponsor's comment is not applicable.									U	11/29/2007	11/30/2007	1		UNK	UNK	Concomitant Drug(s) Not Reported				MEDI0006237	1						1	Cough; Nasal congestion; Neck pain; Pain; Pyrexia; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324578	08/15/2008	NJ	46.0	46		F	12/04/2007	A non-serious report was received from a 46-year-old female consumer coincident with FluMist therapy. No medical history or drug history was reported. The consumer received FluMist from the clinic on 03-Dec-2007. She stated that she had a burning sensation in her nose since receiving the vaccination, a headache since the day of the vaccination and a fever the day after the vaccination. Outcomes for the reported adverse events were not reported. Additional dosing of FluMist is not indicated for current season. The reporter did not provide a causality assessment for the adverse events reported. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U	12/03/2007	12/03/2007	0		MIL	MIL	Concomitant drug(s) Not Reported				MEDI0006241	1						1	Burning sensation; Headache; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324579	08/15/2008	CA				M		A non-serious report of nosebleed was received from a physician concerning a male child over five years of age. The patient had a history of nosebleeds. No concomitant medications were reported. The patient received FLUMIST on an unknown date between 03 Dec 2007 and 07 Dec 2007. The patient experienced nosebleed after FLUMIST administration. No outcome for the event was provided by the reporter. Action taken was not provided. The reporter provided no causality assessment for the event. The pharmaceutical company physician conservatively assessed causality for the event as possibly related to FLUMIST therapy.									U	12/01/2007	12/04/2007	3		OTH	OTH		Nosebleed			MEDI0006285	1						1	Condition aggravated; Epistaxis	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324580	08/15/2008	FL	33.0			F	12/13/2007	A non-serious report was received from a consumer concerning a 33-year-old female, who experienced head congestion, cough and sore throat one day after receiving FLUMIST.  No medical history and concomitant medications were reported.  The patient received one dose of FLUMIST on 07-Dec-2007 in a military clinic.  On 08-Dec-2007, the patient began to experience head congestion, cough and sore throat.  On 13-Dec-2007, the patient reported that the symptoms were somewhat better and indicated that she will be followed up by a military doctor.  The patient did not experience a rechallenge while receiving the suspect vaccine.  The reporter did not provide a statement of causality for the events.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to MEDI-0006287, which is the adverse event report fort the above patient's son.									U	12/07/2007	12/08/2007	1		MIL	OTH	Concomitant Drug(s) Not Reported				MEDI0006209	1						1	Cough; Nasal congestion; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324581	08/15/2008	NJ	12.0			F	12/13/2007	A non-serious report of nasal congestion, fever, sore throat, and headache has been received from a consumer concerning a 12-year-old female. No medical history nor concomitant medications were reported. The patient received FluMist on a Friday (date unknown). Four days later, the patient was sent home with a fever, headache, and severe congestion (sore throat). No outcomes for the events were provided by the reporter, The patient did not experience a rechallenge while receiving the suspect product. The reporter provided no causality assessment for the events. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U					OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0006293	1						1	Headache; Nasal congestion; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324582	08/15/2008	PA	8.0			M		A non-serious report of conjunctivitis was received from a nurse concerning an eight-year-old male.  No medical drug or drug history was reported for this patient.  The patient received FluMist at 6pm on 12-Dec-2007.  Within eight hours of receiving the FluMist, the patient had severe conjunctivitis, with intense redness of sclera and purulent drainage from both eyes.  The outcomes for the reported adverse events were not reported.  Additional FluMist dosing is not indicated.  The reporter did not provide a causality assessment for the adverse events reported.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U	12/12/2007	12/13/2007	1		OTH	OTH	Concomitant drug(s) not reported				MEDI0006294	1						1	Conjunctivitis; Eye discharge; Scleral hyperaemia	FLUN3~MEDIMMUNE VACCINES, INC.~500500P~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324583	08/15/2008	CA	33.0	33		F	12/18/2007	An event of vaccination exposure during pregnancy occurred in a 33-year-old female.  The report was received from a medical assistant.  The client, who was 4-months pregnant at the time of vaccination, did not indicate she was pregnant.  The patient received a one-time dose of FLUMIST on 13-Dec-2007.  On 13-Dec-2007 the reporter indicated FLUMIST was administered to a woman who was four months pregnant at the time.  The patient did not make known her pregnancy prior to the vaccine administration and no adverse events were reported.  Follow up obtained on 09-Jan-08 confirmed no adverse events were reported.  Outcome: no adverse events.  Further dosing with FLUMIST is not indicated.  Causality assessment is not applicable for this vaccine exposure during pregnancy.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. On 01-May-2008 the patient delivered via C-section a healthy male infant that weighed 6.10 ounces. Follow-up informatoin on 06-Oct-2008 includes the mothers pregnancy history and the outcome of this pregnancy.									Y	12/13/2007	12/13/2007	0		PVT	OTH	Concomitant Drug(s) Not Reported	Pregnancy			MEDI0006323	1						1	Caesarean section; Drug exposure during pregnancy	FLUN3~MEDIMMUNE VACCINES, INC.~500500P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324584	08/15/2008	MS	5.0			F		A non-serious report of influenza, temperature of 103 degrees, cough and vomiting was received from a physician concerning a five-year-old female.  No medical or drug history was reported for this patient.  The patient received an initial dose of FLUMIST in October and a booster on 16-Nov-2007.  She had not received influenza vaccinations in previous seasons.  On 18-Dec-2007, the patient presented with a temperature of 103 degrees F with a slight cough and vomiting.  The rapid flu test was positive for both A and B.  Last January, the patient had Flu A with similar symptoms and a positive rapid flu test.  The event outcome is not available.  Additional FLUMIST dosing for this season is not indicated.  The reporter did not provide a causality assessment for the adverse events reported.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U	10/01/2007	12/18/2007	78	Rapid Flu Test, 01/??/07, Positive for Flu A; 12/??/07, Positive for both A & B	OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0006326	1						1	Body temperature increased; Cough; Influenza; Influenza serology positive; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324585	08/15/2008	NY	16.0			F	12/19/2007	A non-serious report was received from a physician of VACCINE EXPOSURE DURING PREGNANCY concerning a 16-year-old female.  No medical history or concomitant medications were reported for this patient.  On 19 Dec 2007, the patient was accidentally administered a FLUMIST vaccine.  The patent was 28 weeks gestation at the time, and the reporter indicated that the patient had no experienced any problems.  No further information was provided.  The pregnancy is ongoing.  Rechallenge is not applicable.  The reporter did not provide a causality statement for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U	12/19/2007	12/19/2007	0		PVT	UNK	Concomitant Drug(s) Not Reported				MEDI0006331	1						1	Drug exposure during pregnancy	FLUN3~MEDIMMUNE VACCINES, INC.~500497P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324586	08/15/2008	FL	8.0			M	12/21/2007	A non-serious report of fever, sore throat and nasal congestion was received from a pharmacist concerning her son, an eight year-old male. No medical history and concomitant medications were reported. The patient received one dose of FluMist vaccine on 13-Dec-2007. One week later on 20-Dec-2007, the patient developed fever of up to 102 degrees, sore throat and nasal congestion. The outcome of the adverse events was not reported. Rechallenge is not applicable. The reporter did not provide a statement of causality for the events. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U	12/13/2007	12/20/2007	7		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0006336	1						1	Nasal congestion; Pharyngolaryngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324587	08/15/2008	IL	30.0			F	02/01/2008	A non-serious report of inadvertently administered two doses of vaccine was received from a healthcare professional concerning a 30-year-old female.  No medical history and concomitant medications were reported.  The patient received two doses of FLUMIST vaccine on 26-Dec-2007.  The inadvertent administration of two doses of FLUMIST vaccine was realized and reported by a physician's office.  On 01-Feb-2008 the reporter and the patient both confirmed that the patient did not experience any adverse events after receiving two doses of FLUMIST on 26-Dec-2007.  Rechallenge is not applicable.  The reporter did not provide a statement of causality.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  Additional info received on 01-Feb-2008: patient did not experience any adverse events.									Y	12/26/2007	12/26/2007	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0006342	1						1	No adverse event; Overdose	FLUN3~MEDIMMUNE VACCINES, INC.~500489P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324588	08/15/2008	MD	48.0	48		F		A non-serious report has been received from a consumer concerning upper respiratory infection with congestion, purulent sinuses and fever in a 48-year-old female. No medical history nor concomitant medications were reported. The consumer received FluMist on 20-Dec-2007. Four days later, she developed congestion, green pus is running out of my nose, fever and an upper respiratory infection. The reporter stated that she was sick for two weeks after she received FluMist last year. The symptoms became more severe and persisted at the time of the report. Additional FluMist dosing is not indicated for the 2007-2008 influenza season. The reporter did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									U	12/20/2007	12/24/2007	4		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0006350	1						1	Paranasal sinus hypersecretion; Pyrexia; Upper respiratory tract congestion; Upper respiratory tract infection	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324589	08/15/2008	OH	46.0			F	12/31/2007	A non-serious report of expired FluMist administered has been received from a nurse concerning a 46-year-old female. No medical history nor concomitant medications were provided. The patient and her three teenage daughters received FluMist on 27-Dec-2007. The expiration date on the FluMist was 25-Dec-2007. No adverse event was reported. As of 21-feb-2008, patient had not experienced any adverse events. The event was resolved on 27-Dec-2007. The reporter was provided information regarding additional dosing of the product when a patient is inadvertently administered product after the expiration date. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is liked to the cases for the patient's three teenage daughters who also received expired FluMist. MEDI-0006352; MEDI-0006353; MEDI-0006354. Additional information received on 21-Feb-2008 and incorporated into the narrative: No adverse event experienced.									Y	12/27/2007	12/27/2007	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0006351	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500488P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324590	08/15/2008	OH				F	12/31/2007	A non-serious report of expired FluMist administered has been received from a nurse concerning a teenage female. No medical history nor concomitant medications were provided. The patient, her mother, and her two teenage siblings received FluMist on 27-Dec-2007. The expiration date on the FluMist was 25-Dec-2007. No adverse event was reported nor on 21-Feb-2008 when contacted for follow-up. The event was resolved on 27-Dec-2007. The reporter was provided information regarding additional dosing of the product when a patient is inadvertently administered product after the expiration date. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is liked to the cases for the patient's mother and two teenage sibling who also received expired FluMist: MEDI-0006351; MEDI-0006353; MEDI-0006354. Additional information received on 21-Feb-2008 and incorporated into the narrative: No adverse even experienced.									Y	12/27/2007	12/27/2007	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0006352	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500488P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324600	08/15/2008	OH				F	12/31/2007	A nonserious report of expired FluMist administered has been received from a nurse concerning a teenage female. No medical history nor concomitant medications were provided. The patient, her mother, and her two teenage sibling resolved FluMist on 27-Dec-2007. The expiration date on the FluMist was 25-Dec-2007. No adverse event was report at the time of the report nor as of 21-Feb-2008 when the reporter was contacted for follow-up. The event was resolved on 27-Dec-2007. The reporter was provided information regarding additional dosing of the product when a patient is inadvertently administered product after the expiration date. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is liked to the cases for the patient's mother and two teenage siblings who also received expired FluMist: MEDI-0006351; MEDI-0006352; MEDI-0006354. Additional information received on 21-Feb-2008 and incorporated into the narrative: No adverse event experienced.									Y	12/27/2007	12/27/2007	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0006353	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~5004488P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324602	08/15/2008	OH				F	12/31/2007	A non-serious report of expired FluMist administered has been received from a nurse concerning a teenage female. No medical history nor concomitant medications were provided.  The patient, her mother, and her two teenage siblings received FluMist on 27-Dec-2007. The expiration date on the FluMist was 25-Dec-2007. No adverse event was reported at the time that the report was received, nor on 21-Feb-2008 when the reporter was contacted for follow-up. The event was resolved on 27-Dec-2007. The reporter was provided information regarding additional dosing of the product when a patient is inadvertently administered product after the expiration date. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to the case for the patient's mother and two teenage siblings who also received expired. FluMist: MEDI-0006351; MEDI-0006353; MEDI-0006352. Additional information received on 21-Feb-2008 and incorporated into the narrative; No adverse event occurred.									Y	12/27/2007	12/27/2007	0		PUB	OTH	Concomitant Drug(s) Not Reported				MEDI0006354	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500488P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324606	08/15/2008	NY	20.0	20		F	12/31/2007	A non-serious report was received from a consumer concerning his 20-year-old daughter. No medical or drug history was reported for the patient. The patient received FluMist on 27-Dec-2008. The following day she developed a sore throat with swollen lymph nodes. The symptoms resolved after two days. Additional FluMist dosing is not indicated. The reporting source did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	12/27/2007	12/28/2007	1		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0006356	1						1	Lymphadenopathy; Pharyngolaryngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~500500P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324607	08/15/2008	IN	6.0			F		A non-serious report of expired FluMist administered was received from a nurse concerning a six-year-old female patient. No medical or drug history was reported. The patient received a booster dose of FluMist on 01-Jan-2008. The patient received her first dose of FluMist on 28-Nov-2007 without any reports of adverse events. The product had an expiration date of 27-Dec-2007. The patient was administered expired FluMist. At the time of the report, no adverse events were reported from this error. Information is being sought for the follow-up with the reporter regarding the outcome of this patient. The reporter did not provided a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	11/28/2007	01/01/2008	34		UNK	UNK	Concomitant Drug(s) Not Reported				MEDI0006357	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500489P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324608	08/15/2008		12.0	12		M	01/03/2008	A serious report of Bell's Palsy was received from a physician concerning a 12-year-old male, PID 82396059, who enrolled in FM025: A Post  marketing Evaluation of the Safety of Influenza Virus Vaccine Live, Intranasal (FluMist) in Healthy Children and Healthy Adults 5 through 49 years of age. The subject had a medical history of oral sores in July and November 2007. The subject did not have a prior history of Bell's Palsy. No concomitant medications were reported. The subject received FluMist vaccine on 12-Nov-2007. On 01-Dec-2007, 19 days after receiving study vaccine, the subject began to experience right facial droop, 24 hours of eye and facial paralysis, uneven smile and eyebrow lift. The following day he was seen at the emergency room and then referred to the clinic. On exam, mild right facial droop was noted. He was able to close his right eye and maintain it closed but weaker than the left eye. Uneven smile and eyebrow lift were also reported. Ear exam on both sides was normal. Tympanic membrane was intact without perforation or effusion, external canal normal. Vital signs and oxygen saturation level were within normal limits. A diagnosis of Bell's Palsy was made. Acyclovir 200 mg/5ml one teaspoon five times a day was prescribed. As of 18-Jan-2008, the event was considered resolved. No further doses of FluMist was given. The subject did not experience a rechallenge. The study investigator assessed the severity of the event as moderate. The study investigator assessed causality as possibly related to study vaccine. The sponsor agreed with the study investigator's causality assessment of possibly related to FluMist. Additional information received on 26-Feb-2008 : resolution date and confirmation that subject did not have prior history of Bell's Palsy.									N	11/12/2007	12/01/2007	19		UNK	UNK	Concomitant Drug(s) Not Reported		Past Disease: Sores mouth		MEDI0006363	1						1	Facial palsy; Ophthalmoplegia; Oxygen saturation normal	FLUN3~MEDIMMUNE VACCINES, INC.~500496P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324609	08/15/2008	CA	9.0			M		A non-serious report of expired FluMist administered was received from a nurse concerning a nine-year-old male patient. No relevant medical or drug history information was reported. The patient received FluMist on 02-Jan-2008. The product had an expiration date of 24-Dec-2007. No adverse events were reported regarding this incidence. The reporter considered the event resolved. The reporter did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not not applicable. 11-Jan-2008: Follow up information obtained and incorporated in above narrative: Clinical outcome.									Y	01/02/2008	01/02/2008	0		UNK	UNK	Concomitant Drug(s) Not Reported				MEDI0006365	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500487P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324611	08/15/2008	RI	10.0			U	01/08/2008	A non-serious event of administration of expired product was received from a health care professional concerning a ten-year-old child. No medical or drug history was provided. FluMist was administered on 04-Jan-2008. The FluMist expired eight days earlier on 27-Dec-2007. Eighteen days after exposure to the expired product, the patient had not experienced ill effects. No additional dosing is indicated. The reporter did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	01/04/2008	01/04/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI006376	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500490P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324612	08/15/2008	RI	14.0			F	01/08/2008	A non-serious event of expired product administered was received from a nurse concerning a 14-year-old female. No medical or drug history was provided. FluMist was administered on 03-Jan-2008. The FluMist expired seven days earlier on 27-Dec-2007. Eighteen days post exposure to the expired FluMist, the patient had not experienced ill effects. No additional dosing is indicated. The reporter did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. The reporter also reported another patient that was exposed to expired product, case MEDI-0006378.									Y	01/04/2008	01/04/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0006379	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500490P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324613	08/15/2008	WA				F		A non-serious report of expired FluMist administered was received from a medical assistant concerning an adult female. No medical or drug history was reported. The patient received FluMist on 08-Jan2008 it was determined that the FluMist was passed the expiry date. No adverse events were reported. No information was provided regarding additional dosing with unexpired FluMist. The reporter did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	01/08/2008	01/08/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0006385	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500441~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324614	08/15/2008	IL	8.0			F	01/09/2008	A non-serious report of expired dose of vaccine administered has been received from a consumer concerning an eight-year-old female. Neither medical history no concomitant medications were provided. The patient received FluMist on 08-Jan-2008. The FluMist that was administered on 08-Jan-2008 had an expiration date of 27-Dec-2007. No adverse events were reported. The event was considered resolved. The patient did not experience a rechallenge while receiving the suspect product. This reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	01/08/2008	01/08/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0006387	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500489F~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324615	08/15/2008	TX				M		A non-serious event of expired product administered was received from a healthcare professional concerning and adult male. No medical or drug history was provided. FluMist was administered on 14-Jan-2008. The FluMist had expired four days earlier on 10-Jan-2008. The patient opted to be revaccinated with either FluMist or FluZone. No signs or symptoms were present at the time of the report. No additional dosing is indicated. The reporter did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	01/14/2008	01/14/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0006414	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500479P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324616	08/15/2008	LA	9.0	9		F	01/29/2008	A non-serious report of expired dose of vaccine administered has been received from a nurse concerning a nine-year-old female patient. Neither medical history nor concomitant medications were provided. The patient received FluMist on 14-Jan-2008. The FluMist had expired on 10-Jan-2008. The reporter indicated that no adverse events have occurred since the time of the report. The patient did not experienced a rechallenge while receiving the suspect product. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. 29-Jan-2008: Follow up information obtained and incorporated in above narrative: clinical outcome.									Y	01/14/2008	01/14/2008	0		UNK	UNK	Concomitant Drug(s) Not Reported				MEDI0006428	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500479P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324617	08/15/2008	LA	38.0	38		M	01/29/2008	A non-serious report of expired dose of vaccine administered has been received from a nurse concerning a 38-year-old male patient.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 14-Jan-2008.  The FluMist had expired on 10-Jan-2008.  The reporter indicated that no adverse events have occurred since the time of the report.  The patient did not experience a rechallenge while receiving the suspect product.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  29-Jan-2008:  Follow-up information obtained and incorporated in above narrative: clinical outcome.									Y	01/14/2008	01/14/2008	0		UNK	UNK	Concomitant drug(s) not reported				MEDI0006429	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500479P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324618	08/15/2008	OH				M	01/15/2008	A non-serious case of inadvertent administration of expired product was received from a nurse concerning an adult male coincident with FluMist. No medical or drug history was provided. FluMist was administered on 14-Jan-2008. The FluMist expired four days earlier on 10-Jan-2008. No signs or symptoms were present at the time of the report. No additional dosing is indicated. The reporter did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	01/14/2008	01/14/2008	0		UNK	UNK	Concomitant Drug(s) Not Reported				MEDI0006433	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500492P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324619	08/15/2008	MA	13.0			F		One of nine cases: An event of Expired Drug Administered occurred in a 13 year-old  female. The report was received from a registered nurse. No medical or drug history was reported. The patient received a one-time dose of FluMist intranasally on 15-Jan-2008. On 15-Jan-2008, she received FluMist with an expiration date of 19-Dec-2007. The reporter stated this is one of nine children that was vaccinated on the same date. In discussing the error with two reporters from the site, they both indicated that the front of the FluMist box states For the 2007/2008 Season, there is an expiration date on the side of the box. The reporter indicated they also administered a competitor's product, which is good for the entire season and does not expire until May/June timeframe. One reporter also stated many of the vaccines they give do not have an expiration date. She also indicated they do look for expiration dates, but it was confusing to have the front of the box indicate the vaccine was For the 2007/2008 Season. The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for up 1 week later, and she was unsure why the site would be supplied with product that was to expire in less than weeks. Outcome: the child had ill effects, the site has not had any contact from  the child's family. Further dosing with FluMist is not indicated. Causality assessment is not applicable for this vaccination error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	01/15/2008	01/15/2008	0		PVT	UNK	Concomitant Drug(s) Not Reported				MEDI0006477	1						1	Expired drug administered; Vaccination complication	FLUN3~MEDIMMUNE VACCINES, INC.~500486P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324620	08/15/2008	MA	7.0			M		Two of nine cases: An event of Expired Drug Administered occurred in a seven year-old male.  The report was received from a registered nurse.  No medical or drug history was reported for this child.  The child received a one-time dose of FluMist intranasally on 15-Jan-2008.  On 15-Jan-2008, the child received FluMist with an expiration date of 19-Dec-2007.  The reporter stated this is one of nine children that was vaccinated on the same date.  In discussing the error with two reporters from the site, they both indicated that the front of the FluMist box states For the 2007/2008 Season, there is an expiration date on the side of the box.  The reporter indicated they also administered a competitor's product, which is good for the entire season and does not expire until May/June timeframe.  One reporter also stated many of the vaccines they give do not have an expiration date.  She also indicated they do look for expiration dates but it was confusing to have the front of the box indicate the vaccine was For the 2007/2008 Season.  The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for pick up 1 week later, and she was unsure why the site would be supplied with a product that was to expire in less than three weeks.  Outcome: the child had no ill effects, the site has not had any contact from the child's family.  Further dosing with FluMist is not indicated.  Causality assessment is not applicable for this vaccination error.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	01/15/2008	01/15/2008	0		PVT	UNK	Concomitant drug(s) not reported				MEDI0006478	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500486P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324621	08/15/2008	MA	9.0			M		One of nine cases: An event of Expired Drug Administered occurred in a nine-year-old male.  The report was received from a registered nurse.  No medical or drug history was reported for this child.  The child received a one-time dose of FluMist intranasally on 15-Jan-2008.  On 15-Jan-2008 the child received FluMist, which had an expiration date of 19-Dec-2007.  The reporter stated this is one of nine children that was vaccinated on the same date.  In discussing the error with two reporters from the site they both indicated that the front of the FluMist box states For the 2007/2008 Season, there is an expiration date on the side of the box.  The reporter indicated they also administered a competitor's product which is good for the entire season and does not expire until May/June time frame.  One reporter also stated many of the vaccines they give do no have an expiration date.  She also indicated they do look for expiration dates but it was confusing to have the front of the box indicate the vaccine was For the 2007/2008 Season.  The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for pick up 1 week later, and she was unsure why the site would be supplied with product that was to expire in less than three weeks.  Outcome: the child had no ill effects, the site has not had any contact from the child's family.  Further dosing with FluMist is not indicated.  Causality assessment is not applicable for this vaccination error.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	01/15/2008	01/15/2008	0		PVT	UNK	Concomitant drug(s) not reported				MEDI0006479	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500486P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324622	08/15/2008	MA	6.0			U		One of nine expired cases: An event of Expired Drug Administered occurred in a six-year-old female. The report was received from a registered nurse . No medical or drug history was reported for the child. The child received a one-time dose of FluMist intranasally on 15-Jan-2008. On 15-Jan-2008, the child received FluMist which had an expiration date of 19-Dec-2007. The reporter stated this is one of nine children that was vaccinated on the same date. In discussing the error with two reporters from the site, they both indicated that the front of the FluMist box states For the 2007/2008 Season, there is an expiration date on the side of the box. The reporter indicated they also administer a competitor's product, which is good for that entire season and does not expire until May/June timeframe. One reporter also stated many of the vaccines they give do not have an expiration date. She also indicated they do look for expiration dates but it was confusing to have the front of the box indicate the vaccine was For the 2007/2008 Season. The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for pick up 1 week later, and she was unsure why the site would be supplied with product that was to expire in less than three weeks. Outcome: the child had no ill effects, the site has not had any contact from the child's family. Further dosing with FluMist is not indicated. Causality assessment is not applicable for this vaccination error. This reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	01/15/2008	01/15/2008	0		PVT	UNK	Concomitant Drug(s) Not Reported				MEDI0006480	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500486P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324623	08/15/2008	MA	13.0			F		One of nine expired cases: An event of Expired Drug Administered occurred in a thirteen year-old female. The report was received from a registered nurse . No medical or drug history was reported. The adolescent received a one-time dose of FluMist intranasally on 15-Jan-2008. On 15-Jan-2008 she received FluMist which had an expiration date of 19-Dec-2007. The reporter stated this is one of nine children that was vaccinated on the same date. In discussing the error with two reporters from the site, they both indicated that the front of the FluMist box states For the 2007/2008 Season, there is an expiration date on the side of the box. The reporter indicated they also administer a competitor's product which is good for that entire season and does not expire until May/June timeframe. One reporter also stated many of the vaccines they give do not have an expiration date. She also indicated they do look for expiration dates but it was confusing to have the front of the box indicate the vaccine was For the 2007/2008 Season. The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for pick up 1 week later, and she was unsure why the site would be supplied with product that was to expire in less than three weeks. Outcome: the child had no ill effects, the site has not had any further contact from the family. Further dosing with FluMist is not indicated. Causality assessment is not applicable for this vaccination error. This reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	01/15/2008	01/15/2008	0		PVT	UNK	Concomitant Drug(s) Not Reported				MEDI0006481	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500486P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324624	08/15/2008	MA	7.0			M		One of nine cases: An event of Expired Drug Administered occurred in a seven-year-old female. The report was received from a registered nurse . No medical or drug history was reported for this child. The child received a one-time dose of FluMist intranasally on 15-Jan-2008. On 15-Jan-2008, the child received FluMist which had an expiration date of 19-Dec-2007. The reporter stated this is one of nine children that was vaccinated on the same date. In discussing the error with two reporters from the site, they both indicated that the front of the FluMist box states For the 2007/2008 Season, there is an expiration date on the side of the box. The reporter indicated they also administer a competitor's product, which is good for that entire season and does not expire until May/June timeframe. One reporter also stated many of the vaccines they give do not have an expiration date. She also indicated they do look for expiration dates but it was confusing to have the front of the box indicate the vaccine was For the 2007/2008 Season. The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for pick up 1 week later, and she was unsure why the site would be supplied with product that was to expire in less than three weeks. Outcome: the child had no ill effects, the site has not had any contact from the child's family. Further dosing with FluMist is not indicated. Causality assessment is not applicable for this vaccination error. This reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	01/15/2008	01/15/2008	0		PVT	UNK	Concomitant Drug(s) Not Reported				MEDI0006482	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500486P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324625	08/15/2008	MA	10.0			M		One of nine cases: An event of Expired Drug Administered occurred in a ten year-old male.  The report was received from a registered nurse.  No medical or drug history was reported for this child.  The child received a one-time dose of FluMist intranasally on 15-Jan-2008.  On 15-Jan-2008 the child received FluMist which had an expiration date of 19-Dec-2007.  The reporter stated this is one of nine children that was vaccinated on the same date.  In discussing the error with two reporters from the site, they both indicated that the front of the FluMist box states For the 2007/2008 Season, there is an expiration date on the side of the box.  The reporter indicated they also administered a competitor's product which is good for the entire season and does not expire until May/June time frame.  One reporter also stated many of the vaccines they give do not have an expiration date.  She also indicated they do look for expiration dates, but it was confusing to have the front of the box indicate the vaccine was For the 2007/2008 Season.  The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for pick up 1 week later, and she was unsure why the site would be supplied with a product that was to expire in less than three weeks.  Outcome: the child had no ill effects, the site has not had any contact from the child's family.  Further dosing with FluMist is not indicated.  Causality assessment is not applicable for this vaccination error.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	01/15/2008	01/15/2008	0		PVT	UNK	Concomitant drug(s) not reported				MEDI0006483	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500486P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324626	08/15/2008	MA	6.0			F		One of nine cases: An event of Expired Drug Administered occurred in a six-year-old female. The report was received from a registered nurse . No medical or drug history was reported for this child. The child received a one-time dose of FluMist intranasally on 15-Jan-2008. On 15-Jan-2008, the child received FluMist which had an expiration date of 19-Dec-2007. The reporter stated this is one of nine children that was vaccinated on the same date. In discussing the error with two reporters from the site they both indicated that the front of the FluMist box states For the 2007/2008 Season, there is an expiration date on the side of the box. The reporter indicated they also administer a competitor's product, which is good for that entire season and does not expire until May/June timeframe. One reporter also stated many of the vaccines they give do not have an expiration date. She also indicated they do look for expiration dates but it was confusing to have the front of the box indicate the vaccine was For the 2007/2008 Season. The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for pick up 1 week later, and she was unsure why the site would be supplied with product that was to expire in less than three weeks. Outcome: the child had no ill effects, the site has not had any contact from the child's family. Further dosing with FluMist is not indicated. Causality assessment is not applicable for this vaccination error. This reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	01/15/2008	01/15/2008	0		PVT	UNK	Concomitant Drug(s) Not Reported				MEDI0006484	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500486P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324627	08/15/2008	MA	7.0			F		One of nine cases: An event of Expired Drug Administered occurred in a seven-year-old female. The report was received from a registered nurse . No medical or drug history was reported for the child. The child received a one-time dose of FluMist intranasally on 15-Jan-2008. On 15-Jan-2008, the child received FluMist which had an expiration date of 19-Dec-2007. The reporter stated this is one of nine children that was vaccinated on the same date. In discussing the error with two reporters from the site they both indicated that the front of the FluMist box states For the 2007/2008 Season, there is an expiration date on the side of the box. The reporter indicated they also administer a competitor's product, which is good for that entire season and does not expire until May/June timeframe. One reporter also stated many of the vaccines they give do not have an expiration date. She also indicated they do look for expiration dates, but it was confusing to have the front of the box indicate the vaccine was For the 2007/2008 Season. The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for pick up 1 week later, and she was unsure why the site would be supplied with product that was to expire in less than three weeks. Outcome: the child had no ill effects, the site has not had any contact from the child's family. Further dosing with FluMist is not indicated. Causality assessment is not applicable for this vaccination error. This reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	01/15/2008	01/15/2008	0		PVT	UNK	Concomitant Drug(s) Not Reported				MEDI0006485	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500486P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324628	08/15/2008	TN	12.0			U		A non-serious report of expired dose of vaccine administered has been received from a health care professional concerning a 12-year-old patient of unknown gender.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 28-Jan-2008.  The FluMist had expired on 14-Jan-2008.  The reporter indicated that no adverse events have occurred since the time of the report.  Rechallenge is not applicable to this adverse event.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	01/28/2008	01/28/2008	0		UNK	UNK	Concomitant drug(s) not reported				MEDI0006495	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500480P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324629	08/15/2008	TX	68.0			F		A nonserious report of expired dose of vaccine administered has been received from a health care professional concerning a 68-year-old female patient. Neither medical history nor concomitant medications were provided. The patient received FluMist on 29-Jan-2008. FluMist is indicated 2-49 year olds. The FluMist had expired on 10-Jan-2008. The patient is a 68-year old. The reporter indicated that no adverse events have occurred since the time of the report. Rechallenge is not applicable. The reporter provided no causality assessment for the event. The reporting source of this spontaneous, thus the sponsor's comment is not applicable.									Y	01/29/2008	01/29/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0006504	1						1	Expired drug administered; Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500479P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324630	08/15/2008	IA	6.0			M		A non-serious report of expired dose of vaccine administered has been received from a healthcare professional concerning a six-year-old male patient.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 29-Jan-2008.  The FluMist had expired on 10-Jan-2008.  At the time of the report, no adverse events were reported from this error.  Rechallenge is not applicable.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	01/29/2008	01/29/2008	0		UNK	UNK	Concomitant drug(s) not reported				MEDI0006506	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500429P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324631	08/15/2008	CA	5.0	5		F	03/04/2008	A non-serious report of expired dose of vaccine administered was received from a physician concerning a five-year-old female. No medical history or concomitant medications were reported. The patient received FluMist vaccine on 05-Feb-2008. The FluMist vaccine administered had an expiration date of 31-Dec-2007. Follow-up call to the reporter after four weeks on 04-Mar-2008 confirmed that the patient did not experience any adverse events after receiving expired FluMist vaccine. The patient did not experienced a rechallenge while receiving the suspect product. The reporter did not provide a statement of causality. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Additional information received on 04-Mar-2008 : reporter confirmed did not experience adverse events.									Y	02/05/2008	02/05/2008	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI006522	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500490P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324632	08/15/2008	CA	31.0	31		F	03/04/2008	A non-serious report of expired dose of FluMist administered was received from a physician concerning a 31-year-old female.  No medical history or concomitant medications were reported.  The patient received FluMist vaccine on 05-Feb-2008.  The FluMist vaccine administered had an expiration date of 31-Dec-2007.  Follow-up call to the reporter after four weeks on 04-Mar-2008 confirmed that the patient did not experience any adverse events after receiving expired FluMist vaccine.  The patient did not experience a rechallenge while receiving the suspect product.  The reporter did not provide a statement of causality.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  Additional information received on 04-Mar-2008: reporter confirmed patient did not experience any adverse events.									Y	02/05/2008	02/05/2008	0		PVT	OTH	Concomitant drug(s) not reported				MEDI0006525	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500430F~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324633	08/15/2008	CA	33.0	33		M	03/04/2008	A non-serious report of expired dose of vaccine administered was received from a physician  concerning a 33-year-old male. No medical history or concomitant medications were reported. The patient received FluMist on 05-Feb-2008. The FluMist vaccine administered had an expiration date of 31-Dec-2007. Follow-up call to the reporter after four weeks on 04-Mar-2008 confirmed that the patient did not experience any adverse event after receiving expired FluMist vaccine. The patient did not experience a rechallenge while receiving the suspect product. The reporter did not provide a statement of causality. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Additional information received on 04-Mar-2008 : reporter confirmed that the patient did not experienced any adverse events. Additional info: received on 21-Nov-2008 : lot number and patient's date of birth.									Y	02/05/2008	02/05/2008	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0006526	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500490P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324634	08/15/2008	IA	23.0			F		A non-serious report of administration of expired FluMist was received from a physician concerning a 23-year-old female.  No medical history or concomitant medications were reported.  The patient received FluMist on 11-Feb-2008.  The patient was administered expired FluMist.  Per the physician, no adverse events were associated with the medication error.  No dechallange or rechallenge occurred.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	02/11/2008	02/11/2008	0		PVT	OTH	Concomitant drug(s) not reported				MEDI0006544	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324635	08/15/2008	TX	31.0			F	02/15/2008	A non-serious report of tachycardia, lightheadedness and tremors was received from a physician in concerning a 31-year-old female. The patient had a medical history of neutropenia. Concomitant medications were not reported. The patient received FluMist vaccine on 24-Oct-2007. Seven hours after receiving FluMist vaccine, the patient became lightheaded, became tachycardic and had tremors. The patient went to the emergency room and the symptoms subsided shortly. The patient recovered from all events, is now asymptomic with no problems. The patient did experience a rechallenge after receiving the suspect product. The reporter did not provide a statement of causality. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	10/24/2007	10/24/2007	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0006568	1						1	Dizziness; Tachycardia; Tremor	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324636	08/15/2008	IA	15.0			F	02/25/2008	A non-serious report of nosebleed has been received from a nurse concerning a 15-year-old female patient.  The patient had no prior medical history and no concomitant medications.  The patient received FluMist and Gardasil on 21-Feb-2008.  The patient developed a bloody nose for two-minutes on 22-Feb-2008 and 23-Feb-2008.  The above event was considered resolved on 23-Feb-2008.  Rechallenge is not applicable to this adverse event.  The reporter did not provide a statement of causality to FluMist.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	02/21/2008	02/22/2008	1		OTH	OTH	GARDASIL				MEDI0006588	1						1	Epistaxis	FLUN3~MEDIMMUNE VACCINES, INC.~500500P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324637	08/15/2008	NJ	14.0	14		F	03/10/2008	A non-serious spontaneous report of flu like symptoms including muscle aches, tiredness and rash has been received from a consumer concerning a 14-year-old female, subsequent to receiving FluMist. No medical history nor drug history was reported.  The child received FluMist nasally on 10-Oct-2007.  The patient's father reported that several weeks after receiving FluMist the patient experienced flu-like symptoms including muscle aches, tiredness and a sporadic rash on the face every once in awhile. The patient's pediatric office, however, stated they have not seen the patient, nor were they notified in reference to a reaction with FLUMIST. The outcome is unknown. The events have not resolved; the child continues to experience these symptoms. Follow-up received on 12-Mar-2008: includes patient demographics and FLUMIST dosing information.									N	10/10/2007	10/11/2007	1		OTH	OTH	Concomitant drug(s) not reported				MEDI0006624	1						1	Fatigue; Influenza like illness; Myalgia; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324638	08/15/2008	CA	36.0			F		A non-serious event of expired dose of vaccine administered was reported by a nurse concerning a 36-year-old female. The patient's medical history and concomitant medications were not reported. On 14-Mar-2008, the patient received FluMist vaccine. It was found out that the FluMist vaccine had an expiration date of 26-Feb-2008. No adverse events, symptoms or any problems were reported. Rechallenge is not applicable. The reporter did not provide a statement of causality. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.									Y	03/14/2008	03/14/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0006642	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324639	08/15/2008	PA	7.0	7		M	03/18/2008	A non-serious report of administration of expired FluMist has been received from a nurse concerning a seven-year old male. Neither medical history nor concomitant medications were provided. The patient received FluMist on 12-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had not adverse events at the time of the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006659; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006673L MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.									Y	03/12/2008	03/12/2008	0		PVT	OTH	Concomitant Drug(s) Not Reported		NI		MEDI0006664	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500489P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324640	08/15/2008	PA	9.0	9		F	03/18/2008	A non-serious report of administration of expired FluMist has been received from a nurse concerning a nine-year-old female. Neither medical history nor concomitant medications were provided. The patient received FluMist on 12-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the Vaccines For Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had no adverse events at the time the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006659; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.										03/12/2008	03/12/2008	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0006665	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324641	08/15/2008	PA	7.0	7		M	03/18/2008	A non-serious report of administration of expired FLUMIST has been received from a nurse in the USA concerning a seven-year old male. Neither medical history nor concomitant medications were provided. The patient received FLUMIST on 12-Mar-2008. The FLUMIST had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FLUMIST from the Vaccines For Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had no adverse events at the time the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not reported whether or not FLUMIST was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 10-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to following 25 other cases reported from he same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-00006659; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDRI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.									Y	03/12/2008	03/12/2008	0		PVT	OTH					MEDI0006666	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324642	08/15/2008	PA	7.0	7		M	03/18/2008	A non-serious report of administration of expired FluMist has been received from a nurse concerning a seven-year-old male.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 12-Mar-2008.  The FluMist had expired on 10-Mar-2008.  The reporter stated that she received 100 doses of FluMist from the Vaccines For Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008.  The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients.  The patient had no adverse events at the time the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information.  The event has resolved.  It was not reported whether or not FluMist was re-administered.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred.  This case is linked to the following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006659; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.									Y	03/12/2008	03/12/2008	0		PVT	OTH	Concomitant drug(s) not reported				MEDI0006669	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324643	08/15/2008	PA	8.0	8		M	03/18/2008	A non-serious report of administration of expired FLUMIST has been received from a nurse concerning an eight-year old male. Neither medical history nor concomitant medications were provided. The patient received FLUMIST on 13-Mar-2008. The FLUMIST had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FLUMIST on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had not adverse events at the time the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not reported whether or not FLUMIST was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006659; MEDI-0006672; MEDI-0006673; MEDI-0006673L MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.									Y	03/13/2008	03/13/2008	0		PVT	OTH	Concomitant Drug(s) Not Reported		NI		MEDI0006671	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324644	08/15/2008	PA	8.0	8		F	03/18/2008	A non-serious report of administration of expired FluMist has been received from a nurse concerning an eight-year-old female.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 13-Mar-2008.  The FluMist had expired on 10-Mar-2008.  The reporter stated that she received 100 doses of FluMist from the Vaccines For Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008.  The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients.  The patient had no adverse events at the time the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information.  The event was resolved.  It was not reported whether or not FluMist was re-administered.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred.  This case is linked to the following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006659; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.									Y	03/13/2008	03/13/2008	0		PVT	OTH	Concomitant drug(s) not reported				MEDI0006673	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324645	08/15/2008	PA	5.0	5		M	03/18/2008	A non-serious report of administration of expired FluMist has been received from a nurse concerning a five-year old male. Neither medical history nor concomitant medications were provided. The patient received FluMist on 13-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the Vaccines For Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 26 patients. The patient had no adverse events at the time the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to the following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006659; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.									Y	03/13/2008	03/18/2008	5		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0006674	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324646	08/15/2008	PA	10.0	10		F	03/18/2008	A non-serious report of administration of expired FLUMIST has been received from a nurse concerning a ten-year old female. Neither medical history nor concomitant medications were provided. The patient received FLUMIST on 13-Mar-2008. The FLUMIST had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FLUMIST from the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had no adverse events at the time of the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not reported whether or not FLUMIST was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-000668; MEDI-0006669; MEDI-00066670; MEDI-00066671; MEDI-00006672; MEDI-00006673; MEDI-0006674; MEDI-0006659; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684									Y	03/13/2008	03/13/2008	0		PVT	OTH					MEDI0006675	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324647	08/15/2008	PA	7.0	7		M	03/18/2008	A non-serious report of administration of expired FluMist has been received from a nurse concerning a seven-year-old male.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 14-Mar-2008.  The FluMist had expired on 10-Mar-2008.  The reporter stated that she received 100 doses of FluMist from the Vaccines For Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008.  The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients.  The patient had no adverse events at the time the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information.  The event has resolved.  It was not reported whether or not FluMist was re-administered.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred.  This case is linked to the following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006659; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.									Y	03/14/2008	03/14/2008	0		PVT	OTH	Concomitant drug(s) not reported				MEDI0006678	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324648	08/15/2008	PA	5.0	5		M	03/18/2008	A non-serious report of administration of expired FluMist has been received from a nurse concerning a five-year old male. Neither medical history nor concomitant medications were provided. The patient received FluMist on 14-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the Vaccines For Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had no adverse events at the time the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to the following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006659; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.									Y	03/14/2008	03/14/2008	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0006680	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324649	08/15/2008	PA	5.0	5		F	03/18/2008	A non-serious report of administration of expired FluMist has been received from a nurse concerning a five-year old male. Neither medical history nor concomitant medications were provided. The patient received FluMist on 14-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the Vaccines For Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 26 patients. The patient had no adverse events at the time the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to the following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006659; MEDI-0006683; MEDI-0006684.									Y	03/14/2008	03/14/2008	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0006682	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500498P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324650	08/15/2008	MA	11.0	11		M	11/06/2007	A serious, spontaneous case of anaphylactic reaction, throat tightness, swollen eyes, hives, wheezing and sneezing has been received from a nurse in an 11-year-old male. Drug and medical history indicated the child was in his sixth year of receiving a series of allergy shots for cat, dog, birch, maple, oak, ragweed, duct, mite and mold. The child has had mild reactions to the allergy shots in the past. It was reported the child had no allergy to eggs but is allergic to sulfa drugs. He has had frequent ear infections and has ADHD. The patient received FluMist intranasally as well as allergy shots at approximately the same time on 24-Oct-2007. The reporter indicated that twenty minutes after administration the child had an anaphylactic reaction including tightness of the throat, swollen eyes, hives, wheezing and sneezing. The child was administered epinephrine and Benadryl; 20 minutes after the treatment his oxygen saturation was 99% and heart rate 105, his chest was clear and the hives resolved. He was transported to the ER where he was observed and released later the same day. The reporter indicated the events resolved the same day. No further information is available on FluMist dosing. The reporter indicated the child's physician and his allergist both thought the reaction was due to FluMist. The reporting source of this case is spontaneous, thus the sponsor's thus the sponsor's comment is not applicable.			Y						Y	10/24/2007	10/24/2007	0		PVT	PUB	ALLERGY SHOT	Multiple allergies; 2) Sulfonamide allergy; 3) ADHD	Child with no allergy to eggs. Received the following allergy shots at the same time as FluMist: 1) cat-dog; 2) birch-maple-oak-grass-ragweed; 3) dust-mite- mold; Child in 6th year of receiving allergy shots; Has frequent infections		MEDI0006112	1						1	Anaphylactic reaction; Eye swelling; Heart rate increased; Oxygen saturation normal; Sneezing; Throat tightness; Urticaria; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500486P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Life Threatening	Influenza
0324651	08/15/2008	TX	9.0			M		A serious life-threatening report has been received from a nurse concerning a nine-year-old male experiencing an anaphylaxis reaction. No medical or drug history has been reported for the patient. The patient received both FLUMIST and VARIVAX vaccinations on 30-Oct-2007. Within five minutes of receiving the FLUMIST and VARIVAX vaccines, the patient experienced an anaphylaxis reaction described as wheezing, shortness of breath, facial edema and facial mottling. He was transported to the hospital. No additional information regarding treatment or outcome was available at the time of this report. Additional dosing of FLUMIST was not reported. The reporter did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.			Y						U	10/30/2007	10/30/2007	0		PVT	OTH					MEDI0006152	1						1	Anaphylactic reaction; Dyspnoea; Face oedema; Livedo reticularis; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~UNKNOWN MANUFACTURER~~UNK~UN~UN~VARICELLA (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0324652	08/15/2008	CA	8.0			M	12/11/2007	A serious report of hypoxia, exacerbation of asthma, and positive for influenza A and B has been received from a physician concerning an eight- year-old male. The patient had a medical history of asthma and was seen in the physician's office on 20-NOV-2007, for a wheezing episode that occurred on 27-Nov-2007. No concomitant medications were reported. The patient received FLUMIST on 28-Nov-2007. On 06-Dec-2007, the patient was hospitalized with hypoxia and exacerbation of asthma. On 09-Dec-2007, the physician tested the patient for influenza and a nasopharynx wash was positive for influenza types A and B. The patient currently remains in the hospital. No outcome for the events was provided by the reporter. The patient did not experience a rechallenge while receiving the suspect product. The reporter provided no causality assessment for the events. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.					Y					11/28/2007	12/06/2007	8	INFLUENZA 12/09/07 Positive for influenza A and B	OTH	OTH	Concomitant Drug (s) Not reported	Asthma			MEDI0006257	1						1	Asthma; Hypoxia; Influenza; Influenza serology positive; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500482P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0322480	08/18/2008	LA	5.0	4		F	08/18/2008	My daughter was administered the flu shot at her well check-up.  Within 14 days, we noticed increased bruising, but she was officially diagnosed with ITP (idiopathic thrombocytopenic purpura) 2 months later when we noticed severe bruising and petechiae.  She was diagnosed with a platelet count of 7000.  She was treated with WinRho by IV.  She was treated many times with WinRho IV for the first year after diagnosis and also with high dose prednisone.  We were urged to have her spleen removed but opted not to and saw a different MD who recommended watching and waiting which we have done for the past 4 years.  She has now attained a higher platelet count but it is not normal.  Several MD's have told us that it is possible it was a result of the flu shot.  She has not been affected for half of her life (5.5 years). 12/1/08-records received-1/30/03-presented to ED with C/O thrombocytopenia. Petechial rash. Five day history of bruises and petechiae.   Presented again on 2/14/03 with platelets of 50,000 and new petechiae. DX idiopathic thrombocytopenia purpura. 1/26/2010 She still has a low platelet count-it has never reached a normal count since she was diagnosed with ITP in January of 2003. Symptoms of brusing started 2 weeks after the vaccine was give, and continues 6 years later.				Y	Y	2			N	11/06/2002	11/20/2002	14	platelet count on 1/30/03 - 7000 12/1/08-records received-Platelet count 7,000 otherwise normal CBC.	UNK	UNK		None 12/1/08-records received-Recent upper respiratory infections.	None 12/1/08-records received-PMH:fractured femur.			1						1	Contusion; Idiopathic thrombocytopenic purpura; Petechiae; Platelet count decreased; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0323479	08/18/2008		15.0			F	08/14/2008	Information has been received from a consumer concerning her approximately 15 year old daughter, who in December 2007, the end of January 2008 and the end of May 2008 was vaccinated with the first, second and third doses of GARDASIL vaccine. Within two weeks after receiving each shot, the patient experienced severe pain in her hips. The pain was so severe she couldn't walk. She had a magnetic resonance imaging of her hips and it was reported ok. To this day, the mother reports that her daughter (the patient) experiences hip pain. No further information is available.									N	12/01/2007	12/15/2007	14	magnetic resonance - hips: reported results = ok	OTH	OTH	Unknown		Unknown		WAES0808USA00138	1						2	Abasia; Arthralgia; Abasia; Arthralgia; Nuclear magnetic resonance imaging normal; Vaccine positive rechallenge	FLUX~SANOFI PASTEUR~U2479AA~2~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~1266U~1~UN~LA~HPV (GARDASIL)~1|HPV4~MERCK & CO. INC.~~1~UN~UN~HPV (GARDASIL)~2	USA		Influenza
0296902	08/19/2008		18.0	18		F	08/18/2008	Information has been received from a registered nurse (R.N.) concerning an 18 year old female with no pertinent medical history, drug reactions or allergies who on 05-NOV-2007 was vaccinated in the right arm with a dose of GARDASIL.  On the same day the patient also received concomitant therapy Flu vaccine (unspecified).  On 05-NOV-2007, 10 minutes after receiving GARDASIL, the patient passed out, and fell on her face.  She had a laceration over her left eye and fractured her cheek bone.  It was reported that the patient was hospitalized and had several surgeries.  The outcome of the patient was not reported. The reporter considered passed out, a laceration over her left eye and fractured her cheek bone to be disabling.  Additional information has been requested.				Y	Y	0		Y	U	11/05/2007	11/05/2007	0	Unknown	OTH	OTH			None		WAES0808USA02488	1						2	Fall; Fracture; Loss of consciousness; Skin laceration; Surgery	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HPV4~MERCK & CO. INC.~~UNK~UN~RA~HPV (GARDASIL)~2	USA	Hospitalisation,Disabling	Influenza
0322546	08/19/2008	DE	27.0	27		F	08/18/2008	A 27-year-old female patient had received a left deltoid, intramuscular injection of FLUZONE SV 2007-2008, lot number U2507AA, on 18 October 2007. It was determined that the patient was approximately two months pregnant at the time of vaccination. Last menstrual period and estimated date of delivery were not provided. Per the reporter, the patient did not experience any adverse event. Follow-up report received from a health care professional on 06 August 2008. On an unspecified date, the patient was found to have polyhydramnios. A level 2 ultrasound performed at 28 weeks gestation showed bilateral hydronephrosis in the fetus. The patient went into premature labor at 32 weeks gestation. on 17 March 2008, 35 weeks gestation, the patient went into labor. A Cesarean section was performed resulting in the live birth of a male, born with bilateral hydronephrosis. The reporter indicated that the mother's health during pregnancy had been unremarkable, except for the polyhydramnios. The reporter of this case is the same as case 2008-02516, the report for the above-mentioned baby.				Y					Y	10/18/2007			Level 2 ultrasound at 28 weeks gestation showed bilateral hydronephrosis.  Alpha feto protein and serologies (dates not specified) were normal.  Increased amniotic fluid was detected on an unspecified date.	PVT	PVT	Prenatal vitamins	The patient had no illness at the time of vaccination.	The patient had a history of attention deficit disorder and four prior pregnancies resulting in three spontaneous abortions and one normal full-term delivery.  There was no family history of congenital anomalies.  The patient had no illness at the time of vaccination.		200703576	1						1	Alpha 1 foetoprotein normal; Amniotic fluid volume increased; Caesarean section; Drug exposure during pregnancy; Foetal disorder; Polyhydramnios; Premature labour; Serology normal; Ultrasound scan abnormal	FLU3~SANOFI PASTEUR~U2507A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0322547	08/19/2008	DE				M	08/18/2008	Initial report received from a health care professional on 06 August 2008.  A male infant born, 151 days after receiving a transplacental dose of FLUZONE (lot number U2507AA) on 18 October 2007, was diagnosed with a congenital anomaly, bilateral hydronephrosis.  The baby was born at 35 weeks gestation by Cesarean section.  Bilateral hydronephrosis was detected in a level 2 ultrasound performed at 28 weeks gestation.  The baby's birth weight was 3.8 kg.  Apgar scores were not reported.  Concomitant medication reported for the mother during pregnancy was prenatal vitamins.  During pregnancy, the baby's mother had experienced polyhydramnios in addition to premature labor at 32 weeks gestation.  The reporter indicated that the mother's health had been unremarkable except for the polyhydramnios.  It was reported that the baby's bilateral hydronephrosis resolved at six weeks of age.  No additional details were provided.  The reporter of this case is the same as case 2007-03576.									Y	10/18/2007	03/17/2008	151	Level 2 ultrasound at 28 weeks gestation detected bilateral hydronephrosis.	PVT	PVT	Prenatal vitamins		Concomitant medication reported for the mother during pregnancy: prenatal vitamins.  There was no family history of congenital anomalies.  During the pregnancy, the baby's mother was experienced polyhydramnios in addition to premature labor at 32 weeks gestation.  Bilateral hydronephrosis was detected in the fetus at 28 weeks gestation.		200802516	1						1	Drug exposure during pregnancy; Foetal disorder; Premature labour; Ultrasound scan abnormal	FLU3~SANOFI PASTEUR~U2507A~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0322669	08/20/2008	NY	70.0	70		F	07/30/2008	Information has been received from a nurse concerning a 70 year old female with a history of glaucoma, Hashimoto's thyroiditis, goeta osteopenia, colonic polyp and RLS-osteoarthritis who on 24-OCT-2007 was vaccinated intramuscularly in the left deltoid muscle with the 1st dose of PNEUMOVAX 23 (lot#658555/0964U).  The patient was concomitantly vaccinated with a influenza virus vaccine (unspecified) on the same day the PNEUMOVAX 23 vaccine was given.  The patient was concomitantly taking glucosamine hydrochloride, chondroitin, calcium (unspecified), vitamins (unspecified), folic acid, timolol maleate (manufacturer unknown), metronadizole, sulfacetamide sodium and EVISTA.  On 24-OCT-2007, post vaccination, the patient could not raise her arm, developed shaking chills, headache, redness and swelling of the left arm and nausea.  No diagnostic lab test were performed.  The patient sought unspecified medical attention and recovered on 25-Oct-2007.  No additional information is expected.				Y					Y	10/24/2007	10/24/2007	0	None	PVT	PVT	calcium (unspecified), chondroitin, folic acid, glucosamine hydrochloride, metronadizole, EVISTA, sulfacetamide sodium, TIMOPTIC, vitamins (unspecified)	Glaucoma; Hashimoto's thyroiditis; Osteopenia; Colonic polyp; Osteoarthritis			WAES0710USA05682	1						1	Chills; Erythema; Headache; Injected limb mobility decreased; Nausea; Oedema peripheral; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0964U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0322907	08/21/2008	TX	6.0	6		F	08/21/2008	Fever of 101 the same night. Sweating, chills. Large red mark on arm, hot to the touch and swollen two days after vaccine.  Put on antibotics...Reaction was to the Pneumonia Vaccine...									Y	08/19/2008	08/19/2008	0		PVT	PVT		None	Heredity Spherocytosis			1						1	Chills; Hyperhidrosis; Injection site erythema; Injection site swelling; Injection site warmth; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~don't know~5~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~don't know~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0323018	08/22/2008	WY				F	08/20/2008	Initial report was received 11 August 2008 from another manufacturer who received the report from a health care professional.  A female patient (age not provided) felt sick and had malaise symptoms for ten months after she [had received a] flu vaccine (manufacturer and lot number not reported) for the first time.  When she was given the flu vaccine the second time she had the same symptoms for six months.  The patients recovery status was not reported.  No further information was provided.				Y									Not reported	UNK	UNK			The patient felt sick and experienced malaise symptoms for 10 months after she received the flu vaccine for the first time.	Malaise~Influenza (Seasonal) (no brand name)~0~0.00~In Patient	200802602	1						1	Malaise; Vaccine positive rechallenge	FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0323019	08/22/2008	PA				F	08/20/2008	Initial report received on 11 August 2008 from another manufacturer, who had received the original report from a health care professional.  Follow-up information was also received on 14 August 2008 via telephone contact with the original reporter who is a health care professional.  A female patient had reported that many years ago she ended up in the hospital after vaccination with an unknown flu vaccine.  At that time, the patient's doctor had told her that the event (which was not specified) was due to the albumin binders in the flu vaccine.  The manufacturer of the flu vaccine was unknown.  The date of vaccination, lot number, route and site of administration was also not reported.  The patient's recovery status was not reported, and no other relevant medically significant information was provided.  No further information is expected.					Y	0							Not reported	UNK	UNK	Not reported		Not reported		200802625	1						1	Vaccination complication	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0323023	08/22/2008	MO				U	08/20/2008	Initial report was received 11 August 2008 from another manufacturer who received the report from a health care professional.  A patient (age and gender not reported) experienced an anaphylactic reaction after receiving a flu vaccination (manufacturer, lot number, route and site not reported).  No further information pertaining to the event or patient's recovery status were provided at the time of the report.				Y									Not reported	UNK	UNK			Not reported		200802601	1						1	Anaphylactic reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0323049	08/22/2008	FL	0.5	0	.5	F	08/15/2008	Was twitching, not as responsive as usual.  No fever or other symptoms.  No definite seizure.				Y					Y	11/16/2007			None	PVT	PUB		None	None			1						1	Depressed level of consciousness; Muscle twitching	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B124BA~3~UN~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2474BA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF201AB~3~UN~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~B08700D~3~UN~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0877U~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0323051	08/22/2008	KY	18.0	18		F	08/18/2008	Patient syncope when standing after immunization striking head on wall. Patient woke rapidly but had persistent complaint of headache and feeling numb all over. Also complained of chest pain occasionally - All VS - were stable - 120/74 BP immediately after.				Y					Y	08/18/2008	08/18/2008	0	CT Scan of head and c/s normal x fen left max sinusitis	PVT	PVT		None	Seasonal Allergic Rhinitis			1						1	Chest pain; Computerised tomogram normal; Head injury; Headache; Hypoaesthesia; Syncope	FLUN3~MEDIMMUNE VACCINES, INC.~500541P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~MERCK & CO. INC.~AHAVB264AA~1~IM~LA~HEP A (VAQTA)~1|MNQ~SANOFI PASTEUR~U2618AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~UF452AA~1~IM~RA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~0137X~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0323357	08/26/2008	OH	14.0	14		F	08/26/2008	After vaccinated patient to waiting room to see if has any side effects. Patient became dizzy. After 5 min. Patient was well enough to drink water and home with mom.									Y	08/25/2008	08/25/2008	0	None	PVT	PVT		none	Previous MRSA boil underarm 3 years ago			1						1	Dizziness	FLUN3~MEDIMMUNE VACCINES, INC.~500541P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0279X~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2632AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2994AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0326251	08/26/2008	NJ	22.0	22		F	04/17/2008	Headache, vomiting, nausea.  Initial report received on 11 April 2008 from a nurse practitioner. A 22 year old female patient received on 26 March 2008 a subcutaneous left arm injection of IPOL (Lot#20474-2), an intramuscular left deltoid injection of FLUSONE (lot#U2479BA) and a first intramuscular right deltoid injection of HAVRIX (GSK, lot#AHAVB144AD). On 28 March 2008, two days post vaccination, the patient developed nausea, vomiting, and a headache for 24 hours. corrective treatment was not reported. The patient had no previous medical history and her only medication was ORTHO TRI-CYCLIN. At the time of the report, 11 April 2008, the patient had recovered.									Y	03/26/2008	03/28/2008	2		OTH	OTH	ORTHO TRI-CYCLIN		No known allergies. No previous medical history. No adverse event		200801056	1						1	Headache; Nausea; Oral contraception; Vomiting	FLU3~SANOFI PASTEUR~U2479B~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB144AD~4~IM~RA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~Ao474~UNK~SC~LA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0323475	08/27/2008	VA	29.0	29		M	08/27/2008	Missing date of 1997 vaccination.  Reported acute hearing loss 6 hours after vaccinated now (2008) requiring hearing aide.  Symptoms: Hearing loss.  10/14/08 Reviewed medical records of 8/26/08. FINAL DX: sensorineural hearing loss left ear  Records reveal patient experienced complete hearing loss of left ear 6 hrs s/p 1997 influenza vaccine.								Y	N	11/01/1997	11/01/1997	0	audiology exams pending from 1997	MIL	MIL	none	Denied	psoriatic rheumatoid arthritis dx in 1995  PMH: cervicalgia, GERD, RA, bronchitis, psoriatic arthropathy, sciatica, chronic pain syndrome, sinusitis, pneumonia, s/p cervical laminectomy, insomnia, heart murmur, gastroenteritis, aortic valve disorder w/bacterial mass, memory lapses, organic hypersomnia idiopathic, HTN, chronic diarrhea, hyperlipidemia, nephrolithiasis, hyperlipoproteinemia type IIB, PTSD, s/p concussion, panic disorder, IBS, chronic rhinitis.  Allergic: cipro, darvocet, trazodone.			1						1	Acoustic stimulation tests; Hearing aid user	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0323479	08/27/2008	PA	16.0	16		F		GARDASIL vaccine and within a 2 week time frame from receiving each dose of the vaccine patient suffered extreme hi pain. The pain was so severe she couldn't walk. Still has hip pain - constant but not as severe. Follow-up Information 30-SEP-2008: I cannot give exact date or time. Events started within a week or 2 weeks after all 3 Gardasil shots.				Y					U	12/03/2007			9/5/08-records received-ANA negative.CRP normal. Rheumatoid factor normal. Lyme AB negative. CBC WNL. MRI lower extremity joint normal.	PVT	UNK	Zyrtec			~Vaccine not specified (no brand name)~~0.00~Patient		1						1	Abasia; Arthralgia; Abasia; Arthralgia; Nuclear magnetic resonance imaging normal; Vaccine positive rechallenge	FLUX~SANOFI PASTEUR~U2479AA~2~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~1266U~1~UN~LA~HPV (GARDASIL)~1|HPV4~MERCK & CO. INC.~~1~UN~UN~HPV (GARDASIL)~2	USA	Emergency room visit	Influenza
0323518	08/27/2008	OR	65.0	65		F	08/27/2008	Since March there has been a rash on my back within 3 days of having the injection-Has persisted ever since.				Y					N	03/11/2008	03/14/2008	3		PVT	UNK			PCN allergy			1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPAB~UNKNOWN MANUFACTURER~~UNK~~~HEP A + HEP B (NO BRAND NAME)~1|TDAP~UNKNOWN MANUFACTURER~~UNK~~~TDAP (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0262657	08/28/2008		18.0			M	07/04/2008	Initial report received on 07 March 2008 from centers.  A search of the CDC VAERS database was completed on 13 March 2008 which also revealed additional information for this case.  This case involves an 18-year-old male, whose past medical history included a cough, and exposure to other recruits with diarrhea, but no history of diarrhea since arrival on 02 August 2006.  The patient has an allergy to Penicillin, but had no other illness, or past medical issues (specifically hypertension, thyroid disorder, diabetes, or epilepsy).  He also had no caffeine, tobacco, or alcohol use.  On 02 August 2006, the patient received a dose of MENOMUNE (lot #, route and site of administration not provided); a dose of MMR (trade name, manufacturer name, route and site of administration not provided); a dose of PNEUMOVAX (trade name, manufacturer name, route and site of administration not provided); and a first dose of TWINRIX (manufacturer GSK, route and site of administration not provided).  On 29 August 2006 the patient subsequently received a first, subcutaneous, left arm dose of YF-VAX (lot # VEG01AA); a first, subcutaneous, right arm dose of IPOL (lot # V1051); a first, intramuscular, right arm dose of ADACEL (lot # C2457AA); a first, intranasal dose of FLUMIST (lot # 500430P, manufacturer Medimmune, Inc./Wyeth laboratories, Inc.); and a second, intramuscular, left arm dose of TWINRIX (lot # AHABB061AA, manufacturer GlaxoSmithKline).  On 30 August 2006, the patient developed progressive ascending weakness in his hands and feet bilateral, with gait disturbance, numbness, pins and needles, intermittent tingling of feet, and calf pains.  He had no fever, rash, headache, stiff neck, diplopia, trouble breathing or swallowing, dysuria, or incontinence.  Physical examination revealed an awake, alert and oriented patient.  Examination of the neck was normal, and neurological examination revealed normal cranial nerves II-XII, no sensory abnormalities, normal muscle tone and bulk, and normal strength of face and neck/cervical spine.  The patient had decreased strength of the upper (4/5) and lower (3/5) extremities (grip strength decreased).  He had asthenia, was unable to walk unassisted, abnormal biceps and brachioradialis (1+) reflexes, absent or diminished ankle jerk, and knee jerk was normal.  The patient's toes were flaccid with Babinski testing.  The patient was subsequently admitted to the intensive care unit in the hospital on 02 September 2006, and his respiratory status was monitored with frequent pulmonary function tests.  He did not require intubation or other respiratory support.  Treatment included Heparin (deep vein thrombosis prophylaxis), and IVIG 42 gm daily for three days.  Diagnostic laboratory studies revealed a lumbar puncture test that was negative for albuminocytologic dissociation but cultures and PCR were still pending at the time of this report.  An EMG revealed electrophysiologic evidence of a severe motor greater than sensory, acquired multifocal sensorimotor peripharal neuropathy with axonal, greater than demyelinating features.  Per the reporter, given the history of the patient, this likely represented a variant of Guillain-Barr syndrome.  Frequent pulmonary function tests.  Result not provided.  Yellow fever studies revealed evidence of recent vaccination with yellow fever vaccine.  No yellow fever viral RNA was detected, and IgM Capture ELISA was negative for all serum samples.  PRNT (+Control >2560) was <10 for serum sample #1, 10 for serum sample #2, 10 for serum sample #3, 20 for serum sample #4, 20 for serum sample #5, 10 for serum sample #6.  The patient was discharged after five days of hospitalization.  Recovery status at the time of this report was unknown.  Guillain Barre Syndrome is an acute inflammatory polyradiculoneuropathy caused by an immune reaction to a preceding event, often an acute infectious illness.  In this case, the young patient might have a exposure to gastrointestinal infection as he had a contact with other recruits with diarrhea.  Yellow fever studies were not in favor of a role of the vaccine in the onset of the event.  Thus, alternative etiology, and in particular Campylobacter jejuni infection, should be searched in this case.					Y	5			U	08/29/2006	08/30/2006	1	Diagnostic laboratory studies revealed a lumbar puncture test that was negative for albuminocytologic dissociation.  Cultures and PCR were still pending at the time of this report.  An EMG revealed electrophysiologic evidence of a severe motor greater than sensory acquired multifocal sensorimotor peripharal neuropathy with axonal greater than demyelinating features.  Frequent pulmonary function tests.  Result not provided.  Yellow fever studies revealed evidence of recent vaccination with yellow fever vaccine.  No yellow fever viral RNA was detected, and IgM Capture ELISA was negative for all serum samples.  PRNT (+Control >2560) was <10 for serum sample #1, 10 for serum sample #2, 10 for serum sample #3, 20 for serum sample #4, 20 for serum sample #5, 10 for serum sample #6.	UNK	UNK	None	The patient had no concurrent illness except for a cough and exposure to other recruits with diarrhea, but no history of diarrhea since arrival to the base on 02 August 2006.	The patient had no concurrent illness except for a cough and exposure to other recruits with diarrhea, but no history of diarrhea since arrival to the base on 02 August 2006.  Past medical history included allergy to penicillin, but no other illness, or past medical issues (specifically hypertension, thyroid disorder, diabetes, or epilepsy), and he had no caffeine, tobaccco, or alcohol use.		200800753	1						5	Areflexia; Asthenia; Axonal neuropathy; Blood immunoglobulin M; Blood test normal; Dyskinesia; Electromyogram abnormal; Extensor plantar response; Gait disturbance; Hypoaesthesia; Hypotonia; Immunology test; Lumbar puncture normal; Muscular weakness; Pain in extremity; Paraesthesia; Peripheral sensory neuropathy; Physical examination normal; Areflexia; Asthenia; Babinski reflex test; Culture; Electromyogram abnormal; Gait disturbance; Grip strength decreased; Hypoaesthesia; Hypotonia; Immunology test; Immunology test normal; Joint range of motion decreased; Lumbar puncture normal; Muscular weakness; Neurological examination normal; Neuropathy peripheral; Pain in extremity; Paraesthesia; Polymerase chain reaction; Pulmonary function test; Viral test negative; Asthenia; Blood product transfusion; CSF cell count normal; CSF protein increased; Electromyogram abnormal; Fatigue; Guillain-Barre syndrome; Impaired work ability; Neuropathy peripheral; Pain in extremity; Quadriparesis; Abasia; Areflexia; Asthenia; Axonal neuropathy; Babinski reflex test; Blood product transfusion; CSF culture; Electromyogram abnormal; Gait disturbance; Grip strength decreased; Guillain-Barre syndrome; Hypoaesthesia; Immunology test; Intensive care; Lumbar puncture; Lumbar puncture normal; Muscular weakness; Pain in extremity; Paraesthesia; Peripheral sensorimotor neuropathy; Polymerase chain reaction; Pulmonary function test; Reflexes abnormal; Serology normal	FLUN3~MEDIMMUNE VACCINES, INC.~500430P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|IPV~SANOFI PASTEUR~Y1051~1~SC~RA~POLIO VIRUS, INACT. (IPOL)~2|TDAP~SANOFI PASTEUR~C2457AA~1~IM~RA~TDAP (ADACEL)~2|YF~SANOFI PASTEUR~VEG01A~1~SC~LA~YELLOW FEVER (YF-VAX)~2|FLUN3~MEDIMMUNE VACCINES, INC.~500430P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB061AA~2~IM~LA~HEP A + HEP B (TWINRIX)~3|IPV~SANOFI PASTEUR~Y1051~1~SC~RA~POLIO VIRUS, INACT. (IPOL)~3|TDAP~SANOFI PASTEUR~C2457AA~1~IM~RA~TDAP (ADACEL)~3|YF~SANOFI PASTEUR~VEG01A~1~SC~LA~YELLOW FEVER (YF-VAX)~3|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~4|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~HEP A + HEP B (TWINRIX)~4|IPV~SANOFI PASTEUR~~UNK~UN~UN~POLIO VIRUS, INACT. (IPOL)~4|TDAP~SANOFI PASTEUR~~UNK~UN~UN~TDAP (ADACEL)~4|YF~SANOFI PASTEUR~~UNK~UN~UN~YELLOW FEVER (YF-VAX)~4|FLUN3~MEDIMMUNE VACCINES, INC.~500430P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~5|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB061AA~2~IM~LA~HEP A + HEP B (TWINRIX)~5|IPV~SANOFI PASTEUR~Y1051~1~SC~RA~POLIO VIRUS, INACT. (IPOL)~5|TDAP~SANOFI PASTEUR~C2457AA~1~IM~RA~TDAP (ADACEL)~5|YF~SANOFI PASTEUR~VEG01A~1~SC~LA~YELLOW FEVER (YF-VAX)~5	USA	Hospitalisation	Influenza
0303733	08/28/2008		19.0			M	07/04/2008	This case was received from the Centers for Disease Control and Prevention (CDC), on 07 March 2008. A 19-year-old male received the following vaccines on 16 September 2007: MMR, polysaccharide pneumococcal vaccine, and meningococcal conjugate vaccine (manufacturers and lot numbers not provided). Prior to vaccination he had been in excellent health, other than a brief episode the previous summer of sore throat and fever (up to 105 degrees), later attributed to viral illness. On 08 October 2007, he presented with sore throat, congestion, and purulent cough; a physical exam revealed swollen tonsils, and a chest x-ray was negative. Treatment included Cepacol, pseudoephedrine extended release, Tylenol, guaifenesin, oxymetazoline spray, and a Maalox/Lidocaine/Benadryl gargle. Symptoms improved over a few days. On 16 October 2007 he complained of a pruritic rash, which appeared primarily on his trunk and T-shirt area. He was diagnosed with urticaria, due to use of a new fabric softener, and treated with Benadryl. Later that day he received the following vaccines: YF-VAX (lot number UE912AA), IPOL (lot number Z0421), Diphtheria and Tetanus Toxoid (sanofi-pasteur, lot number as AC52B024AA), TWINRIX (GlaxoSmithKline, lot number AHABB100AA), and FLUMIST (MEDIMMUNE, lot number 500485P, inhaled). On 19 October 2007, three days after vaccination, he complained of watery nasal discharge, shortness of breath with exertion, temperature of 100.5 F, and headache. A repeat chest x-ray was negative, and he was treated with Tylenol, Cepacol, guaifenesin, pseudoephedrine LA, and Tessalon. On 26 October 2007, ten days after vaccination, the patient complained of headache and neck stiffness. He became lethargic and unresponsive, and collapsed. He was taken to a clinic, where his temperature was noted to be 102.3 F. His Glasgow Coma scale rating went from a score of 14 (on a scale of 3 to 15) to 10, with incontinence. He underwent a lumbar puncture, and cerebrospinal fluid (CSF) WBC was found to be 2240 with 82% polys (polymorphonuclear leukocytes). He was treated with 1gm of Rocephin, 2 gm of ampicillin, acyclovir, and dexamethasone, and then evacuated by air to a nearby medical center with a presumed diagnosis of meningitis. He was admitted to the intensive care unit, where additional treatment included vancomycin and rifampin. A lumbar puncture reported on 27 October 2007 noted the CSF to be clear, with glucose 87 (normal 40-70), protein 66 (normal 12-60), WBC 75 (normal 0-8), RBC 98 (normal 0), diff PMN 19%, L 28%, mono 53%. Gram stain was negative for organisms, initial meningococcal and S. pneumoniae antigen tests were negative, and cultures showed no growth after three days. PCR tests on CSF for herpes simplex viruses (HSVI and HSVZ), varicella-zoster virus, and HMV6 were also negative. Additional testing performed by the Project showed the following: Serum test WNV <0.5, IgM 0.03, Epstein Barr virus (IPA) >10, Epstein Barr Virus Nuclear Antigen >10, mycoplasma IGM negative, and Parvovirus B-19 IgM (IFA acute serum) <10. Chemistry profile revealed: sodium 132 (normal 136-144), potassium 3.3 (normal 3.6-5.1), chloride 98 (normal 101-111), BUN 5 (normal 8-26), Creatinine 0.6 (normal 0.7-1.2); serum cortisol was 1.50. Complete blood count showed: hemoglobin 13.8, hematocrit 40.6, and white blood count 9.4. Throat swab was negative for Influenza A and B, human metapneumovirus. RSV type A, enterovirus, and mycoplasma. A CT with contrast on 27 October 2007 showed only right sphenoid sinus disease, with no evidence of meningeal enhancement, intracranial hemorrhage, or parenchymal masses. An MRI on 29 October 2007 showed diffuse white matter increased signal without enhancement, a pattern most suggestive to ADEM. This pattern could also be seen in the setting of Lyme disease. Serum lyme titer drawn 31 October 2007 was positive (45 kd IgG reactive), but Igm was negative (nonreactive).  The patient's mental status slowly improved, and after two days he was able to transfer out of the ICU. He remained hospitalized until 05 November 2007, at which time he was considered to be recovered to near baseline capacity. The discharge diagnosis was acute disseminated encephalomyelitis (ADEM). On 20 November 2007, the patient was seen by an infectious disease specialist disease as an outpatient. The consulting physician felt that ADEM was the probable diagnosis, in the setting of recent upper respiratory infection and recent vaccination and that the specific infectious etiology had not yet been identified. The patient was scheduled to ascertain yellow fever IgM levels; all testing was negative. Additional testing by the CDC detected no yellow-fever antibody post-vaccination, and no virus was isolated in the serum. RPR (rapid plasma regain) was also negative. On 21 November 2007 the patient had a follow-up appointment with a neurologist, at which time the patient stated that he was back to about 75% cognitively, with complaints of forgetfulness, difficulty concentrating, and slight weakness in the arms, legs, and hand grip. He also complained of decreased sensation in the fingers. Complete neurologic exam was normal, and he was referred for neurocognitive testing. This testing was performed on 28 November 2007, and revealed average to above-average results in all areas except verbal fluency, which was average. During an evaluation in the Vaccine Healthcare Center on 30 November 2007, the patient continued to complain of slight weakness and difficulty concentrating. A quality of life self-assessment, performed on 03 December 2007, revealed slight decrements in perceived physical function, physical role, vitality,and physical component summary scales.  Nervous system disorder such as acute disseminated encephalomyelitis is listed event for yellow-fever vaccine. It needs to be underlined that the patient had experienced rhinorrhea, fever and shortness of breath 7 days before main symptoms of ADEM occurred. Nevertheless, etiology work-up for infectious etiologies is fairly exhaustive and the role of the yellow-fever vaccine needs to be considered.					Y				U	10/16/2007	10/19/2007	3	26/Oct/2007: He underwent a lumbar puncture, and cerebrospinal fluid (CSF) WBC was found to be 2240 with 82% polys (polymorphonuclear leukocytes). A lumbar puncture reported on 27 October 2007 noted the CSF to be clear, with glucose 87 (normal 40-70), protein 66 (normal 12-60), WBC 75 (normal 0-8), RBC 98 (normal 0), diff PMN 19%, L 28%, mono 53%. Gram stain was negative for organisms, initial meningococcal and S. pneumoniae antigen tests were negative, and cultures showed no growth after three days. PCR tests on CSF for herpes simplex viruses (HSVI and HSVZ), varicella-zoster virus,a nd HMV6 were also negative. Additional testing performed by the Project showed the following: Serum test WNV <0.5, IgM 0.03, Epstein Barr Virus (IPA) >10, Epstein Barr Virus Nuclear Antigen >10, myoplasma IGM negative, and Parvovirus B-19 IgM (IFA acute serum) <10, Chemistry profile revealed: sodium 132 (normal 136-144), potassium 3.3 (normal 3.6-5.1), chloride 98 (normal 101-111), BUN 5 (normal 8-26), Creatinine 0.6 (normal 0.7-1.20), serum cortisol was 1.50. Complete blood count showed: hemoglobin 13.8, hematocrit 40.6, and white blood count 9.4. Throat swab was negative for Influenza A and B, human metapneumovirus, RSV type A, entervirus, and mycoplasma. A CT with contrast on 27 October 2007 showed only right sphenoid sinus disease, with no evidence of meningeal enhancement, intracranial hemorrhage, or parenchymal masses. An MRI on 29 October 2007 showed diffuse white matter increased signal without enhancement, a pattern most suggestive of ADEM. This pattern could also be seen in the setting of Lyme disease. Serum lyme titer drawn 31 October 2007 was positive (45 kd IgG reactive), but IgM was negative (nonreactive).	UNK	UNK	CEPACOL; PSEUDOEPHEDRINE EXTENDED; RELEASE; TYLENOL; GUAIFENESIN; OXYMETAZOLINE; MAALOX/LIDOCAINE/BENADRYL GARGLE; BENADRYL;		Brief episode of sore throat with temperature to 105 the previous summer (thought to be viral). On 08 October 2007 presented with sore throat, congestion, purulent cough. On 16 October 2007 be 08 October 2007 presented with sore throat, congestion, purulent cough. On 16 October 2007 he presented with a pruritic rash, thought to be urticaria.		200800754	1						3	CSF culture negative; CSF glucose increased; CSF protein normal; Cognitive disorder; Dysarthria; Enterovirus serology test negative; Fatigue; Haematocrit; Haemoglobin; Laboratory test normal; Leukoencephalomyelitis; Musculoskeletal stiffness; Nuclear magnetic resonance imaging brain abnormal; Polymerase chain reaction; Protein total; Red blood cell count; Serology positive; Stupor; Tremor; Urinary incontinence; White blood cell count normal; Bacterial test negative; Blood chloride decreased; Blood cortisol decreased; Blood creatinine decreased; Blood homocysteine; Blood potassium decreased; Blood sodium decreased; Blood urea decreased; Body temperature increased; Borrelia burgdorferi serology; CSF cell count normal; CSF glucose increased; CSF protein increased; CSF white blood cell count increased; Computerised tomogram abnormal; Culture negative; Culture throat negative; Disturbance in attention; Dyspnoea; Enterovirus serology test negative; Epstein-Barr virus antibody positive; Full blood count; Glasgow coma scale; Gram stain negative; Granulocyte count increased; Grip strength decreased; Haematocrit decreased; Haemoglobin decreased; Headache; Incontinence; Laboratory test abnormal; Lethargy; Leukoencephalomyelitis; Lumbar puncture; Lymphocyte percentage; Mechanical ventilation; Memory impairment; Metapneumovirus infection; Monocyte percentage increased; Muscular weakness; Musculoskeletal stiffness; Neurological examination normal; Nuclear magnetic resonance imaging abnormal; Parvovirus B19 serology; Polymerase chain reaction; Red blood cells CSF positive; Respiratory syncytial virus serology; Rhinorrhoea; Sensory loss; Syncope; Unresponsive to stimuli; Varicella zoster serology negative; Viral test negative; Virus serology test negative; White blood cell count normal; Antibody test negative; Blood chloride decreased; Blood cortisol decreased; Blood creatinine decreased; Blood culture negative; Blood glucose increased; Blood immunoglobulin M; Blood potassium decreased; Blood sodium decreased; Blood urea decreased; Body temperature increased; Borrelia burgdorferi serology positive; CSF cell count increased; Chest X-ray normal; Computerised tomogram abnormal; Culture negative; Culture throat negative; Disturbance in attention; Dyspnoea; Epstein-Barr virus antibody positive; Glasgow coma scale; Gram stain negative; Haematocrit normal; Haemoglobin decreased; Headache; Herpes simplex serology; Incontinence; Lethargy; Leukoencephalomyelitis; Lumbar puncture; Lymphocyte percentage; Mechanical ventilation; Meningitis; Monocyte percentage increased; Muscular weakness; Musculoskeletal stiffness; Mycoplasma serology; Neurological examination normal; Nuclear magnetic resonance imaging abnormal; Parvovirus B19 serology; Pharyngolaryngeal pain; Productive cough; Protein total increased; Pyrexia; Rash pruritic; Red blood cell count increased; Respiratory tract congestion; Rhinorrhoea; Sensory loss; Syncope; Syphilis test negative; Tonsillar hypertrophy; Unresponsive to stimuli; Varicella zoster serology negative; Viral infection; White blood cell count increased; White blood cell count normal; Yellow fever	FLUN3~MEDIMMUNE VACCINES, INC.~500485P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB100AA~1~UN~UN~HEP A + HEP B (TWINRIX)~1|IPV~UNKNOWN MANUFACTURER~Z0421~1~UN~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~1|TD~SANOFI PASTEUR~AC52B024AA~1~UN~UN~TD ADSORBED (NO BRAND NAME)~1|YF~SANOFI PASTEUR~UE912AA~1~UN~UN~YELLOW FEVER (YF-VAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500485P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB100AA~UNK~UN~UN~HEP A + HEP B (TWINRIX)~2|IPV~SANOFI PASTEUR~Z0421~UNK~UN~UN~POLIO VIRUS, INACT. (IPOL)~2|TD~SANOFI PASTEUR~AC52B024AA~UNK~UN~UN~TD ADSORBED (NO BRAND NAME)~2|YF~SANOFI PASTEUR~UE91211~UNK~UN~UN~YELLOW FEVER (YF-VAX)~2|FLUN3~MEDIMMUNE VACCINES, INC.~500485P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB100AA~UNK~UN~UN~HEP A + HEP B (TWINRIX)~3|IPV~SANOFI PASTEUR~Z0421~UNK~UN~UN~POLIO VIRUS, INACT. (IPOL)~3|TD~GLAXOSMITHKLINE BIOLOGICALS~AC52B024AA~UNK~UN~UN~TD ADSORBED (DITANRIX)~3|YF~SANOFI PASTEUR~UE912AA~UNK~UN~UN~YELLOW FEVER (YF-VAX)~3	USA	Hospitalisation	Influenza
0323637	08/28/2008	GA	36.0	36		F	08/25/2008	Two weeks after receiving the vaccine, I had acute onset of severe vertigo lasting 10 days, followed by nine months and counting of debilitating positional (with movement) dizziness. Vestibular neuritis and migraine have both been suggested, but illness doesn't quite fit either diagnosis. I considered the flu vaccine connection when I found out that three other women on my dizzy health board developed the same condition (thought first to be neuritis and then possibly migraine vertigo) two to four weeks after receiving the flu vaccine. None of us had ever experienced any dizziness before in our lives.  09/17/2008 PCP records received. OV 12/3/2007 with c/o nausea and dizziness as well as nasal congestion. PE (+) for mild visible fluid lines in the ears, pale edematous tubinates with decreased patency on L.  Assess: Dizziness.  URI.  Returned 12/6/07 with increasing sx now descibed as debilitating. Feels dizzy with head movement. Increased anxiety 2' to vertigo. PE WNL. Assess:  Vertigo.  URI.  Anxiety.  Returned 5/20/08, now with 5 month hx of dizziness, lightheadedness, H/A, sleep problems, visual changes, weakness and fatigue. Has seen ENT and neuro- suspect vistibular neuritis or vestibular migraine. Depression 2' to sx. Assessment:  Acute sinusitis.  Dizziness. Place on abx with no improvement.				Y				Y	N	11/16/2007	12/01/2007	15	I've had MRI (normal), hearing (normal), and VNG testing (positional nystagmus). Labs and Diagnostics:  MRI brain WNL.  CT sinuses (+) for L maxillary sinus infection.	UNK	UNK		None	None. PMH: Recent root canal. Anxiety, Asthma, LEEP.  Allergy to codeine./			1						1	Acoustic stimulation tests normal; Diagnostic procedure; Dizziness postural; Electronystagmogram abnormal; Vertigo	FLU3~SANOFI PASTEUR~U2478BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0323640	08/28/2008	CA	87.0	87		F	08/28/2008	Pt was in pharmacy at bedginning of the year ( 2008 ) and reported a red spot at the injection site. Returned in July this year and showed the pharmacist a persistant red spotting at the injection site. Pt was instructed to seek medical help.At this time we are not aware of treatment, diagnosis.										10/06/2007			unknown	UNK	PVT	Unknown	Unknown	Unknown			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~v2504aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0323654	08/28/2008	MN	13.0	13		M	08/27/2008	Awoke 2 AM 8/23/08 with severe headache, nausea, nasal congestion. Seen in office 8/23 AM - exam unremarkable, treated with Tylenol 1000 mg reassurance.				Y					Y	08/22/2008	08/23/2008	1	None	PVT	PVT	Adderall xR 20mg; Retin A; hadn't started either before event)	None	None			1						1	Headache; Nasal congestion; Nausea	FLUN3~MEDIMMUNE VACCINES, INC.~S00544P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB258AA~1~IM~LA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2580AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0323657	08/28/2008	NE	10.0	10		F	08/29/2008	Flumist given when expired - no treatment needed - no adverse effects. Dad was notified and chose not to revaccinate.									Y	02/29/2008				PVT	UNK						1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500497P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0323785	08/29/2008	VA	25.0	25		M	08/29/2008	Within an few hours of receiving FLUMIST developed abdominal cramping, followed by diarrhea.  Fatigue, weight loss, abd pain and cramping, depression these persisted from Thanksgiving holiday till present.  Initially, diagnosed as IBS and then later Celiac disease.  Patient still intermittantly has symptoms.				Y					N	11/19/2007	11/19/2007	0	IBS, Celiac disease.	MIL	MIL		None	NKA, NKDA, childhood hearing loss secondary to recurrent ear infections.			1						1	Abdominal pain; Coeliac disease; Depression; Diarrhoea; Fatigue; Irritable bowel syndrome; Weight decreased	FLUN3~MEDIMMUNE VACCINES, INC.~~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0323807	08/31/2008	AZ	42.0	42		F	08/31/2008	I am a nurse practitioner and received the vaccine at the office where I practice, which is also my primary care physician.  I have had flu vaccines yearly since childhood but I have never had any reaction.  In less than 12 hours after the vaccine, I developed SEVERE and UNRELENTING total-body muscle and joint aches that did not improve with NSAID or narcotic medication.  I had a severe headache, profound fatigue, fever up to 101, sweats, chills, sore thoat, cough, and nasal congestion.   I was sick for over 8 days, spent 6 days fully confined to bed, and missed 2 days of work.  I had not been sick prior to the vaccine.  I treated myself with NSAIDs, fluids, rest, and antibiotics, but nothing improved my situation except time.									Y	08/23/2008	08/24/2008	1	None done	PVT	PVT	Humalog insulin per pump, Coreg CR, Altace, Exforge, Singulair, Crestor, Seasonale, Vicodin, Ibuprofen, Asmanex, Albuterol, Cymbalta, Ambien	None - was feeling fine at time of vaccine.	Type 1 diabetes, asthma, hypertension, hyperlipidemia, fibromyalgia, depression, insomnia.			1						1	Activities of daily living impaired; Arthralgia; Chills; Cough; Fatigue; Headache; Hyperhidrosis; Myalgia; Nasal congestion; No reaction on previous exposure to drug; Pain; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U2745aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0323894	09/02/2008	NY	11.0	11		F	09/02/2008	Fainted about 5 minutes after vaccine administration									Y	09/02/2008	09/02/2008	0		PVT	PVT		None	None			1						1	Syncope	FLUN3~MEDIMMUNE VACCINES, INC.~500543P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U2726AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~UF452AA~1~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0323918	09/02/2008	CA	69.0	69		F	08/25/2008	10 hours after shot, I had pain all over my body - joints, muscular pains, needles.  Diagnostic: Guillain-Barre syndrome, frozen shoulders, tendinitis, bursitis, arthritis.  Recommendation for physical therapy. 9/18/08-records received for DOS 11/16/06-C/O feeling sick for 3 days. Returned to office for uric acid results 5.2. Neurology consult 2/21/07-C/O pain in left arm diagnosed as tendonitis pain increased in intensity in right shoulder spread to left shoulder with some weakness. DX:bilateral shoulder sprain, rule out adhesive capsulitis or impingement syndrome.   6/18/09 Consultant medical records received DOS 2/21/09. Previously included with primary care provided records - no new codes.				Y					N	11/09/2006	11/10/2006	1	Diagnostic: Guillain Barre syndrome, frozen shoulders, tendinitis, bursitis, arthritis.	PUB	UNK	None	None	None - can prove w/medical records.PMH:Gout. Allergy Penicillin.  9/18/08-records received-			1						1	Arthralgia; Arthritis; Bursitis; Myalgia; Pain; Paraesthesia; Periarthritis; Tendonitis; Anorexia; Arthralgia; Arthritis; Asthenia; Bursitis; Food allergy; Gout; Guillain-Barre syndrome; Hypokinesia; Impaired driving ability; Insomnia; Myalgia; Myositis; Pain; Paraesthesia; Paralysis; Periarthritis; Pharyngolaryngeal pain; Pyrexia; Swelling; Tendonitis; Toothache; Weight decreased; X-ray	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0324018	09/03/2008	TX	1.0	1	.0	F	09/03/2008	Erytheme multiforme minor									U	09/02/2008	09/03/2008	1	N/A	PVT	PVT		Diarrhea and diaper rash.	None			1						1	Erythema multiforme	FLU3~SANOFI PASTEUR~4T2782A15~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHA0B2Y4CCA~1~UN~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0931X~1~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0485V~1~UN~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0324043	09/03/2008	VA	5.0	5		M	08/20/2008	Posterior neck lymphadenopathy; Fever (low grade); Papular rash on trunk/lower extremities; Start 24 hours ago				Y					N	08/19/2008	08/20/2008	1	None	PVT	PVT	Folic Acid	None	1. Single gene mutation on the MTHFR gene. 2. Allergy testing (+) Allergic Dust mites and cat			1						1	Lymphadenopathy; Pyrexia; Rash papular	DTAP~SANOFI PASTEUR~C2956BA~5~IM~LL~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500543P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~A0491~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0239X~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0102X~2~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0324066	09/03/2008	TX	11.0	11		M	09/03/2008	Swelling - Redness - Warm				Y					Y	08/22/2008	08/24/2008	2	None	PVT	PVT		None	None	None~ ()~~0.00~Patient|None~ ()~~0.00~Sibling|None~ ()~~0.00~Sibling		1						1	Erythema; Skin warm; Swelling	FLUN3~MEDIMMUNE VACCINES, INC.~500543P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U2664AA~1~UN~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~~6~UN~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0324072	09/03/2008	NV	52.0	52		F	08/27/2008	Severe pain followed by loss of function in left shoulder.  Treated with anti-inflammatory meds then physical therapy and ten steroid injection.									N	11/22/2007	11/25/2007	3	MRI, lab work, aspiration of joint.	PVT	UNK		None	Hypertension, sulfa allergy			1						1	Aspiration joint; Laboratory test; Nuclear magnetic resonance imaging; Pain; Periarthritis	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0323918	09/04/2008	CA	69.0	69		F		I was a healthy woman prior to the flu shot I had on 11.09.06 at 3:30 pm in the Doctor's Office.  I use to have a flu shot once a year w/no reaction.  On 11.10.06 at 1:20 am I wake up with pain all over my body.  Muscular pain, back pain, arms, shoulder, hip pains, needles, joints, throat pain, fever, tooth and jaw pain.  Because of all this pain, I lost my appetite, sleepless and I lost in the first 6 months 10 pounds and became very weak.  On 10.15.06 started to feel stronger, muscular pain, sharp hips, joint pain, right hand, right leg, knee swelling and the pain from arms goes to the back of my body.  I was unable to move well or drive.  On 11.16.06, I visited my regular doctor where I had the flu shot but he denied that the problems are from the flu shot.  I did not take any medication in general or prior vaccine.  I have no family history of any illness and I use to visit the Doctor only for a regular check-up.  My diagnostic was Guillain Barre Syndrome, adhesive capsulitis, frozen shoulders, tendinitis, bursitis, arthritis w/recommendation for physical therapy.  I did on my own accupuncture, massages, I follow an organic diet, organic suppliments BUT after 18 + months, I am not well.  I am still suffering from muscular pain, tremendous weakness sensation in the legs, arms, upper body, hips, joint pain and I become allergic to a lot of foods and in particular to eggs and chicken.  I feel that viruses from this vaccine activate my immune system inappropriately and my body being infected triggered all these problems I never had and with all my effort can't be healed.  My life is upside-down, I am not the person I used to be anymore, friends and customers that knew me for years now tell me how they see me every day just disappearing.  Suppose the vaccine to protect people from illness, NO, to make them sick or disabled.  I would like to know your opinion in this situation and what are my chances of becoming healthy again.  Patient c/o muscle pain x 2 mo - 69 year old female with ch 2 mo h/o.  Patient had flu shot, knelt down, had pain all over body.  Hand swelling and right knee swelling, paralysis x 2 weeks.  Patient took Motrin.  Patient seen at clinic for arthritis - gout.  Patient states takes exercise and diet changes.  No tenderness.  Has forearm muscle tenderness, knee muscle tenderness.  A - 1 myositis/gl b syndrome, muscle pain, P - 1 x-ray both hands, right knee, 2 - medical record release, 3 - Physical therapy 12 weeks, muscle strengthening.										11/09/2006				UNK	UNK						1						2	Arthralgia; Arthritis; Bursitis; Myalgia; Pain; Paraesthesia; Periarthritis; Tendonitis; Anorexia; Arthralgia; Arthritis; Asthenia; Bursitis; Food allergy; Gout; Guillain-Barre syndrome; Hypokinesia; Impaired driving ability; Insomnia; Myalgia; Myositis; Pain; Paraesthesia; Paralysis; Periarthritis; Pharyngolaryngeal pain; Pyrexia; Swelling; Tendonitis; Toothache; Weight decreased; X-ray	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0324292	09/05/2008	DE	15.0	15		F	08/29/2008	Severe headaches (immed. after 1st course) continuing almost daily.  Joint aches, extreme malaise and lethargy.  (2 visits to eye specialist - reported to physician).  9/23/08 Reviewed PCP medical records & vaccine records.  PCP office called parent for status check as they were unaware of any problems patient had.  Office states patient had severe HA after 1st & 3rd HPV vaccines.  Parent reports patient is completely asymptomatic now.  Eye exam of 12/31/07 reveals clear vision & no pain. 1/26/2010 Headaches have lessend but still occurring.				Y				Y	N	11/19/2007	11/20/2007	1	Eye exams (2 different Opt.)	PVT	PVT		N/A	None  PMH: cupping of optic disc.  Eye itch & burn.  Hypermetropia, painful menses, using contraception to regulate.  Excision of chalazia bilateral lower eyelids.  Adopted.  Family hx cancer.  HPV #2 given 1/29/08, Lot # 1265U; HPV #3 given 6/10/08, Lot # 1757Y, RA.			1						1	Arthralgia; Headache; Immediate post-injection reaction; Lethargy; Malaise	FLU3~SANOFI PASTEUR~UT2458BA~6~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1266U~1~UN~LA~HPV (GARDASIL)~1	USA	Disabling	Influenza
0324310	09/05/2008	CO	2.0	2	.0	M	09/03/2008	8/30/2008 Awoke from nap and appeared fatigue, whole body began shaking and convulsing lasted 5 min total. POC took to ED. ED course IV NS Bolus, CBC and BMP drawn, more alert after fluid bolus and patient discharged home with parents.				Y					Y	08/29/2008	08/30/2008	1		PVT	UNK		none	Adopted child			1						1	Convulsion; Fatigue; Full blood count; Metabolic function test; Tremor	FLU3~SANOFI PASTEUR~U2743AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB243AA~2~IM~LL~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0324358	09/05/2008	CA	4.0	4		M	09/05/2008	Father called 9/4 at 9:30 a.m. PST to report patient had fever to 105F, chills, harsh breathing. Advised father to bring to pt to office for eval. for rx to Flu Mist (MedImmune) given 9/3 at 4:30 p.m. PST. Physical exam: HEENT WNL, Lungs CTA, no abnl findings.				Y					Y	09/03/2008	09/04/2008	1	U/A neg	UNK	UNK		Afebrile, no illness.	No allergies, no birth defects.			1						1	Breath sounds abnormal; Chills; Pyrexia; Urine analysis normal	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0324382	09/06/2008	NE	8.0	8		F	09/06/2008	noticed the day after injection on left arm:  small pimple at injection site, light swelling around injection site, light rash around injection site, painful to touch area around injection site									U	09/04/2008	09/04/2008	0		UNK	UNK	Allegra	None	seasonal allergies			1						1	Injection site pain; Injection site papule; Injection site rash; Injection site swelling	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~UNKNOWN MANUFACTURER~~1~IM~RA~HEP A (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~2~IM~LA~VARICELLA (NO BRAND NAME)~1	USA		Influenza
0324384	09/07/2008	MS	43.0	43		M	09/07/2008	Head ache, fatigue, GI upset(nausea) onset 15 minutes post Flumist									U	09/07/2008	09/07/2008	0	NONE	MIL	MIL	NONE	NONE	NONE	N/A~ ()~NULL~~In Patient|N/A~ ()~NULL~~In Sibling1|N/A~ ()~NULL~~In Sibling2		1						1	Abdominal discomfort; Fatigue; Headache; Nausea	FLUN3~MEDIMMUNE VACCINES, INC.~500551P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0324476	09/08/2008	VA	1.25	1	.3	F	09/08/2008	MOM REPORTED HIVES ON LEFT THIGH. RESOLVED UPON ARRIVAL TO OFFICE. LEFT THIGH SOFT WITHOUT HIVES OR REDNESS PER MD.									Y	09/05/2008	09/05/2008	0	NONE	PVT	PVT	NONE	NO	NONE			1						1	Injection site urticaria	FLU3~SANOFI PASTEUR~UT2782EA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C68308~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0430X~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0324666	09/09/2008	FL	65.0	64		F	09/09/2008	EMPLOYEE CAME AFTER RECEIVING VACCINE. LEFT UPPER ARM RED HOT AND EDEMATOUS. COMPLAINT OF FOREHEAD AND NOSE ITCHING.CALLED PHARMACY AND DISPENSED BENADRYL 50 MG. ICE PACK TO LEFT UPPER ARM. HAVE EMPLOYEE CHECKING IN WITH NURSE MANAGER TO CHECK UPPER ARM AND STATUS OF EMPLOYEE. EMPLOYEE INSTRUCTED TO COME SEE ME IF SYMPTOMS BECOME WORSE AND WILL ALSO CHECK IN FIRST THING TOMORROW MORNING.									Y	09/09/2008	09/09/2008	0		PVT	UNK	NONE	NO	NONE			1						1	Erythema; Oedema peripheral; Pruritus; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88635~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0324670	09/09/2008	VA	0.8	0	.8	M	09/09/2008	After receiving flu shot developed a fever that was on and off for a week. Used Tylenol and motrin with no effect. He completly changed after that. Would not respond to name no eye contact. We took him to get hearing test done, no problems. Took him to specialist... AUTISM SPECTRUM DISORDER.  9/29/2008 PCP office notes received beginning with 9 mon WCC 11/10/06. PE WNL. Frequent UR sx throughout early 2007. 15 mon WCC 5/1/07 with no expressive words or pointing to body parts. 1 word vocab at 18 months. Delayed speech noted 7/20/07 as well as food aversions. Neuro referral-3/2008. 12/4/08 MR received from neuro dated 6/23/08 with DX: Autistic Spectrum Disorder. 1/26/2010 Autism-Encephalopathy.								Y	N	11/10/2006	01/01/2007	52	you will have to get dates, times ,lot #'s and such from Dr office or I can submit a request for his records	UNK	UNK	None	none	NONE	Autism~Influenza (Seasonal) (no brand name)~2~0.80~Patient		1						1	Abnormal behaviour; Acoustic stimulation tests normal; Autism spectrum disorder; Pyrexia; Social avoidant behaviour; Unresponsive to stimuli	FLU3~SANOFI PASTEUR~UT2058A~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0324682	09/09/2008	PA	0.5	0	.5	M	09/09/2008	After receiving vaccinations, my son was developing a fever at 102 degree at that night.  I treated him tylenol infants' drop 0.6ML at 8:30pm.  After one hour, his fever was not decreased.  I called his doctor and was advised to treat him tylenol again after 4 hours.  Around 10pm, my son was getting so weak, vomit, moaning and febrile convulsion.  He was taking his second tylenol at 12:30am.  In the next morning, he had low-grade fever and no appetite.									Y	09/08/2008	09/08/2008	0	N/A	PVT	UNK	n/a	have a cough	n/a			1						1	Anorexia; Asthenia; Febrile convulsion; Moaning; Pyrexia; Vomiting	DTP~UNKNOWN MANUFACTURER~~UNK~~~DTP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~UNK~~~HIB (NO BRAND NAME)~1|OPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, ORAL (NO BRAND NAME)~1	USA		Influenza
0324693	09/09/2008	NE	5.0	5		M	09/09/2008	Swelling of left leg from upper thigh to below knee-increasing knot. Inability to bear weight.									U	09/08/2008	09/08/2008	0		PVT	PVT		None	Eczema			1						1	Oedema peripheral; Weight bearing difficulty	DTAP~SANOFI PASTEUR~C2934AA~5~IM~LL~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500541P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~A0805~UNK~SC~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0807X~UNK~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~A0805~2~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0324734	09/10/2008	MA	6.0	6		M	09/04/2008	Near syncopal event immediately following Flumist.  Patient had increased heart rate, decreased blood pressure, pallor, diaphoresis and disorientation, all self resolved.				Y					Y	09/04/2008	09/04/2008	0		PVT	PVT		None	None			1						1	Blood pressure decreased; Disorientation; Heart rate increased; Hyperhidrosis; Immediate post-injection reaction; Pallor; Presyncope	FLUN3~MEDIMMUNE VACCINES, INC.~500544P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0324801	09/10/2008	KY	66.0	66		M	09/09/2008	Fever, nausea, vomiting, stomach upset - kidney shut down - unable to urinate - excessive sweating									Y	09/08/2008	09/08/2008	0		OTH	PVT						1						1	Dysuria; Hyperhidrosis; Nausea; Pyrexia; Renal disorder; Stomach discomfort; Vomiting	FLU3~SANOFI PASTEUR~U2753AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0324802	09/10/2008	KY	66.0	66		U		- Swelling in upper arm down to elbow - stiffness - some pain - some sweating/nausea									Y	09/09/2008	09/09/2008	0		OTH	PVT						1						1	Hyperhidrosis; Musculoskeletal stiffness; Nausea; Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~U2753AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0162X~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0324838	09/11/2008	WA	16.0	16		F	09/08/2008	Received shot about 5 p.m. - at 7 p.m. appeared pale and complained of being tired; slept 7-10 p.m. at 10 p.m. complained of feeling nauseated, felt dizzy at midnight appeared pale, the walls looked weird, fuzzy.									Y	09/04/2008	09/04/2008	0		PVT	PVT		None	None			1						1	Dizziness; Fatigue; Nausea; Pallor; Visual disturbance	FLU3~SANOFI PASTEUR~U2745AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0324848	09/11/2008	KY	4.0	4		M	09/08/2008	9-8-08 Patient comes in today after being see at the ER last night for cellulitis. Did receive his 4 year shots on Friday, two days ago. Was given DTaP and the flu vaccine in his left leg. Mom states that there was a small red area on Friday, usual of his immunizations. On Saturday it had grown somewhat and yesterday it spread quite a bit. Was complaining of tenderness and a low grade fever up to 99. Went onto the ER and was placed on Bactrim and Keflex. A circle was drawn around the area. This had not spread any. Is red and indurated when pressed. Is very tender to the touch. Mom states that the redness was much worse yesterday. He does not have a fever currently. Temp is 98.9 A: Cellulitis, possibly secondary to a vaccine reaction. We will go ahead and report this to the vaccine adverse reaction secondary to the large area of cellulitis. He will continue on the Bactrim and Keflex. Mom knows to call me right away if he gets fever or if this area is spreading outside the lines that were drawn at the ER. She will keep a close eye on this and let me know how he does. Otherwise we will see patient as needed.				Y					U	09/05/2008	09/06/2008	1	None	PVT	OTH	None	None	None			1						1	Cellulitis; Erythema; Induration; Pyrexia; Tenderness	DTAP~SANOFI PASTEUR~C2955BA~5~UN~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2786AA~4~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0805~4~UN~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0319X~2~UN~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0917X~2~UN~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0324879	09/11/2008	CA	0.8	0	.8	F	09/11/2008	Generalized urticaria, no respiratory symptoms. Seen at hospital.  Had Benadryl.				Y					Y	09/10/2008	09/10/2008	0		UNK	UNK	hydrocortisone 1% for eczema	moderate eczema	eczema, no known food allergies			1						1	Urticaria	FLU3~SANOFI PASTEUR~UT2785AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0324885	09/11/2008	CA	16.0	16		M	09/11/2008	muscle pain and weakness starting 1 day after flu vaccine- Leg/Arms with development of reactive disorders. CK increased 30003, Dx Myositis 9/19/08 Reviewed hospital medical records of 9/9-9/11/2008. FINAL DX: Myositis Records reveal patient experienced progressively worsening muscle pain, weakness, throat soreness & arms tingling.  Tx w/IVF.  Improved & d/c to home.					Y	2			Y	09/02/2008	09/03/2008	1	9/8/05, CK, 3547; 9/10/08, CK, 1639  LABS: Initial CK 3547(H), final CK 949.  CRP 0.15.  UA neg. Influenza A&B neg.	PVT	PVT	MINOCYCLIN; BENZACLIN; RETIN A	None	None			1						1	Blood creatine phosphokinase increased; Muscular weakness; Myalgia; Myositis	FLU3~SANOFI PASTEUR~U2756AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0324889	09/11/2008	PA	1.0	0	1	F	09/11/2008	fever, febrile seizure				Y						09/10/2008	09/11/2008	1		PVT	PVT		None	None			1						1	Febrile convulsion; Pyrexia	FLU3~SANOFI PASTEUR~UT2782EA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1884U~3~UN~LL~HEP B (RECOMBIVAX HB)~1|HEPA~MERCK & CO. INC.~AHAVB291AA~1~UN~RL~HEP A (VAQTA)~1|PNC~PFIZER\WYETH~C45721E~1~SC~LA~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0604X~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0325106	09/15/2008	PA	54.0	54		M	09/15/2008	This case was reported by a pharmacist and described the occurrence of neuropathy in a 54-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included allergy to NSAID and seasonal allergic rhinitis. There were no concurrent medications. On 19 November 2007 at 12:00 the subject received a dose of FLULAVAL in the left arm. On the evening of 19 November 2007, less than one day after vaccination with FLULAVAL, the subject developed mild inflammation at the injection site. Later, on 20 November 2007, the subject developed an achy feeling, soreness in rib case, numbness from the mid-chest downward, loss of tactile sensation from the waist down, a slight tingling in the extremities (fingers and toes), an inability to urinate for about 8 to 10 hours, impotence and pain in the shoulder and scapula bilaterally (more severe on left injection side). The subject's body temperature was normal. The next day, on 21 November 2007, the subject experienced right leg weakness (leg gave way while walking downstairs). His body temperature was still normal. On 22 November 2007, the subject continued to experience weakness and severe dizziness was noted. The subject was unable to drive a car. Right leg weakness continued (leg gave way while walking downstairs for the second time). On 25 November 2007, impotence resolved, but shoulder, rib and chest soreness continued. The subject's body temperature was normal. The next day, on 26 November 2007, urination was better, but it was still difficult to start urine flow. There was suspected prostate involvement. The subject was started on Bactrim DS twice daily for 21 days. On 05 December 2007, general weakness was improving and mild dizziness continued. On 12 December 2007, acute symptoms resolved, mild dizziness, generalized muscle weakness and tenderness persisted. On 13 December 2007, the subject met with a urologist and he was diagnosed with transient neuropathy, probably related to the flu shot. It was described like Guillain-Barre Syndrome. The pharmacist considered the events were clinically significant (or requiring intervention). As of 15 June 2008, general muscle weakness and tenderness persisted, especially around the upper body. As of 11 September 2008, muscle tenderness persisted throughout the upper body, but the subjects legs were okay. The reporter stated that the following had resolved: muscle tenderness and generalized upper body soreness. The reporter felt that causality of the events to FLULAVAL was probable.									U	11/19/2007	11/19/2007	0	13 December 2007: Subject met with urologist and complete physical done, digital rectal examination conducted, PSA = 0.7 (normal).  Diagnosis given: transient neuropathy probably related to flu shot, like Guillain-Barre Syndrome.	OTH	OTH	No concurrent medication	Allergy to NSAID; Seasonal Allergic Rhinitis	The subject has experienced rhinitis and wheezing upon taking NSAIDs.  The subject has received flu vaccines in the past and has no history of any reactions with previous flu shots.  Additionally, the subject has no history of adverse events following previous vaccinations.		A0747368A	1						1	Chest pain; Dizziness; Dysuria; Erectile dysfunction; Hypoaesthesia; Impaired driving ability; Injection site inflammation; Muscular weakness; Musculoskeletal chest pain; Musculoskeletal pain; Neuropathy peripheral; Pain; Paraesthesia; Prostatic specific antigen normal; Rectal examination; Sensory loss; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFUA076AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0325110	09/15/2008	CA	8.0	8		M	09/13/2008	Arm was red knotty from shoulder to elbow. Resolved with BENADRYL over 48-72 hr.									Y	09/11/2008	09/12/2008	1		PVT	PVT			RAD			1						1	Erythema; Induration	FLU3~SANOFI PASTEUR~U2743AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0325112	09/15/2008	TX	40.0	40		F	09/15/2008	09-12-08 530 PM Dizzy, Diaphoretic, painful in arm all the way down to wrist within minutes after vaccine ->lay down for 10 minutes felt better. 10 minutes later called office to report she had passed out while driving. Advised to go to the ER -									Y	09/12/2008	09/12/2008	0		PVT	PVT		None	None			1						1	Dizziness; Hyperhidrosis; Loss of consciousness; Pain in extremity	FLU3~SANOFI PASTEUR~U27564A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0325113	09/15/2008	TX	24.0	24		F	09/15/2008	Arm soreness all the way down to wrist.									Y	09/12/2008	09/12/2008	0		PVT	PVT		None	None			1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U27564U~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0325132	09/15/2008	NY	65.0	65		M	09/15/2008	I had severe and very painful swelling starting around the area where the shot was administered. Then the sweeling and pain traveled to my left underarm, elbow and forearm. The shot was administered on 9/9/2008 and within 24 hours it left me unable to bend my left arm completely. The IV  in my left arm was also affected and had to be moved a day later.A week later I still have pain and some swelling,especially around the area where the IV was. I was on antibiotics for a different problem the whole time this reaction took place.									N	09/09/2008	09/09/2008	0	Blood culture was taken on or about 9/11/08. Results are still unknown by me.	PVT	UNK		Diverticulitis	none			1						1	Axillary pain; Blood culture; Injection site pain; Injection site swelling; Oedema peripheral; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA358AA~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0622x exp 03/10~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0325136	09/15/2008	HI	18.0	18		M	09/15/2008	Satiellate lesion on left shoulder next to primary.									Y	09/08/2008	09/12/2008	4		MIL	MIL						1						1	Skin lesion	ANTH~EMERGENT BIOSOLUTIONS~FAV142~1~SC~RA~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500547P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~EMERGENT BIOSOLUTIONS~VV04-003A~1~ID~LA~SMALLPOX (ACAM2000)~1	USA		Influenza
0325145	09/15/2008	AK	11.0	11		F	09/15/2008	Mother described localized site reaction 6 inches diameter, swollen, hot, red, painful. Worse yesterday than today. Visited physician who explained localized site reaction and drew a line around induration with marker to watch for changes (according to mother). Observation only, no treatment, report back if worsens.									U	09/13/2008	09/14/2008	1	n/a	UNK	PVT	unknown	no	unknown			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Local reaction	FLU3~SANOFI PASTEUR~U2742AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0325231	09/16/2008	CO	4.0	4		F	09/08/2008	Rolled eyes for about 60 sec. Stared x 2 at preschool two hours after receiving influenza vaccine and Hep A ped.									Y	09/07/2008	09/07/2008	0	Visit to check in office	PVT	UNK		Mild sneezing	Coarctation of aorta			1						1	Eye rolling; Staring	FLU3~GLAXOSMITHKLINE BIOLOGICALS~U2787EA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUARIX)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB284DA~1~IM~RL~HEP A (HAVRIX)~1	USA		Influenza
0325232	09/16/2008	PA	4.0	4		F	09/10/2008	Cold symptoms started 9-7-08. On 9-9-08 started with generalized pain in arms, legs, buttocks. Pain especially severe in hips and legs. Pain was so severe on 9-9-08 that parent took child to E.R.				Y					U	09/03/2008	09/07/2008	4		PVT	PVT	MIRALAX prn	None	None			1						1	Arthralgia; Nasopharyngitis; Pain in extremity	DTAP~SANOFI PASTEUR~C2958AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2748AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB264AA~2~IM~LA~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0483~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0325235	09/16/2008	MI	39.0	38		F	09/16/2008	Pt has area of 9.5X4 cm on  left deltoid that is reddened and tender to the touch. Pain extends toward left subclavicular area. No numbness or radiation down affected arm reported. Symptoms started within 3 hours of vaccination.									U	09/13/2008	09/13/2008	0		MIL	MIL	Multi Vitamin	N/A	NKDA, No Birth defects, No medical conditions			1						1	Erythema; Pain; Tenderness; Wrong drug administered	DTAP~SANOFI PASTEUR~C2965BA~1~IM~LA~DTAP (TRIPEDIA)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500551P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0325240	09/16/2008	CA	18.0	18		F	09/16/2008	My 20 yr. old daughter received her first vaccine in December of 2007.  In February of 2008 she began not feeling well and actually passed out at work one day and hit her head.  The following day she saw her primary care physician who thought maybe her feeling ill and vomiting was a result of the fall.  From that point on she has never been the same.  We had not connected her symptoms to the vaccine so in March of 2008 she received her second vaccine.  Things went downhill with her health after that.  She developed severe abdominal pain, acid reflux, vomiting after eating anything and everything, headaches, extreme fatigue, constant nausea, body aches, and diarrhea on a daily basis.  The PCP then began running multiple tests.  She had an abdominal ultrasound, upper GI, CT scan with contrast (which she went into anaphylactic shock from the contrast and had to go the the ER), and multiple blood tests.  She was then referred to a GI specialist who ran additional blood work and ordered an upper endoscopy with small bowel follow-through. He gave her a prescription for Compazine to help with the nausea which she was not able to take because it caused her to sleep too much.  The tests were normal.  He then ordered an abdominal Doppler ultrasound which also was normal.  He told her maybe it was IBS and prescribed Bentyl and Reglan to try and ran some additional blood work.  She was not able to continue with the Bently because after a week of taking it she began to have severe memory loss and mental confusion. She is a hairstylist who loves her job.  She is fortunate enough to have a boss who has understood her frustration and feelings through this whole ordeal. However, she has missed an outrageous amount of work and is losing clients due to her constant illness. She has lost over 20 pounds and is beginning to look malnourished. She is due for her third vaccine and will not receive it.   The past weekend she was admitted to the hospital through the ER.  They ran additional blood work, chest x-ray and MRI of her head.  She also had an evaluation from a neurologist who will be performing an EEG. So far, all tests have been normal and we are still awaiting the results of the heavy metal toxicity blood work.  She is still extremely ill and no one can figure out how to help her.  I am at my wits end! I am convinced that the Gardasil vaccine had something to do with her illness.  Prior to the vaccine she was a happy, healthy young adult who was just getting started in her career and now she is feeling like a miserable old sickly person.  Hospital records of 9/12-9/14/2008 reviewed. FINAL DX: weight loss; intractable nausea & vomiting that is intermittent Records reveal patient experienced nausea, vomiting, weight loss, FTT, possible memory loss, forgetfulness, twitching.   9/30/08 Reviewed PCP medical records of 6/21/07-9/24/2008 including hospital records of 9/12-9/14/08. FINAL DX: none provided Records reveal patient experienced pharyngitis & viral syndrome on 2/4/07 & received flu vaccine, Lot # 80956.  RTC 2/19/08 w/anxiety, rapid breathing, passed out & hit her head, vomiting, neck/hip/torso/LBP pain.  Dx w/anxiety & muscle spasm.  Meds changed & referred to psych.  RTC 5/5/08 & c/o not feeling well since mono 10 yrs prior with daily HA, vomiting & intermittent diarrhea, fatigue, arthralgias, 20# weight loss w/o trying, had stopped OCP.  Tx w/PPI for gastritis.  Referred to GYN, GI & Neuro & all w/u WNL.  GI dx w/eating disorder, Neuro dx w/anxiety.  Endocrine consult felt was GI related.  RTC 9/12 w/dyspraxia, N/V & clummsiness.				Y	Y	2			N	02/04/2007	02/18/2008	379	SEE ABOVE #7  LABS: pelvic US WNL.  UGI WNL but revealed splenomegaly.  CT of abdomen revealed hepatomegaly & possible splenic varices with portal hypertension.  US of abdomen essentially WNL.  MRI brain WNL.  Duodenal biopsy WNL.  Esophageal biopsy w/benign squamous papilloma. MRI of c-spine revealed straightening of cervical lordosis & mild disc desiccation at C5-6.	UNK	UNK			PCN  PMH: infected lacriminal cannula, anxiety/depression.  Family hx ulcers, Crohns, leukemia. HPV #1 3/14/08 Lot # 1448U, RA; HPV #2, 5/16/08, Lot #1978U, LA.			1						1	Abdominal pain; Activities of daily living impaired; Amnesia; Anaphylactic shock; Blood test; Chest X-ray normal; Computerised tomogram normal; Confusional state; Contrast media allergy; Diarrhoea; Endoscopy normal; Fatigue; Gastrooesophageal reflux disease; Head injury; Headache; Hypersomnia; Laboratory test normal; Loss of consciousness; Malaise; Malnutrition; Nausea; Pain; Ultrasound Doppler normal; Ultrasound abdomen normal; Vomiting; Weight decreased	FLUX~UNKNOWN MANUFACTURER~80956~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0325248	09/16/2008	OH	13.0	13		M	09/16/2008	30 mins after receiving FluMist pts. left eye began watering every time he blinked and his lip became numb and started getting hot flashes. Pt. came to the office the following day c/o left eye going from excessively watering to excessively dry.  Left side of face became droopy the morning after he got Flumist.  Pt. diagnosed with Bells Palsy, treated with Acyclovir, DexPak, and Lacrilube.									U	09/11/2008	09/11/2008	0		UNK	UNK	Pt. had taken Tylenol, Benadryl, and a nasal spray earlier on the day of the vaccine.	Pt c/o sth, nasal congestion, and feeling tired. Diagnosed with upper respiratory infection and pharyngitis.	none			1						1	Dry eye; Facial palsy; Hot flush; Hypoaesthesia oral; Lacrimation increased	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0325251	09/16/2008	CA	51.0	51		M	09/16/2008	Pt broke out in a rash from the elbow up to shoulder, with welts and swelling of the shoulder				Y					Y	09/12/2008	09/12/2008	0		UNK	UNK						1						1	Rash; Swelling; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflla159aa~2~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0200u~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0325265	09/16/2008	TX	16.0	16		F	09/16/2008	1 hr after receiving FLUMIST/ pt developed facial numbness, chest and throat tightness with pain and wheezing				Y					Y	09/15/2008	09/15/2008	0		PVT	PVT	None	None	None			1						1	Chest discomfort; Hypoaesthesia facial; Pain; Throat tightness; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500557P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0572X~1~IM~LA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0291282	09/17/2008	PR	33.0	33		M	09/12/2008	On 9 Jan 2003 he received 11 vaccines while preparing for foreign travel: Patient states that tremors started in right hand the next day on 10 Jan 03 (medical records confirm this). He was experiencing anxiety problems at the time and was sent to another location where the tremor was diagnosed as 'benign idiopathic tremor' (no records available). He was subsequently hospitalized for anxiety and depression for 2 months and release from activity duty. His tremor was then thought to be related to anxiety. The right hand tremor continued and then a new tremor started in left hand and left foot one year later. The tremors have been unchanged since 2004. He states the symptoms wax and wane in intensity and often interfere with work as electronic technician. He has fallen in the past from the leg tremors. His spouse says he does not have tremor during sleep. The tremor worsens with concentrated use of the hand or foot such as when using tools, typing, using a mouse, holding a fork, or when driving and using a clutch or climbing a ladder.  Symptoms: Tremors.				Y				Y	N	01/09/2003	01/10/2003	1	one EMG positive for motor neuron d/o, next EMG negative for any abnormalities	MIL	MIL	None	Anxiety D/o, depression				1						2	Activities of daily living impaired; Anxiety; Depression; Electromyogram abnormal; Essential tremor; Fall	ANTH~MICHIGAN DEPT PUB HLTH~FAV065~UNK~UN~UN~ANTHRAX (NO BRAND NAME)~2|FLU3~SANOFI PASTEUR~U0983AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|HEP~GLAXOSMITHKLINE BIOLOGICALS~ENG5379A4~UNK~UN~UN~HEP B (ENGERIX-B)~2|HEPA~MERCK & CO. INC.~0032N~UNK~UN~UN~HEP A (VAQTA)~2|IPV~SANOFI PASTEUR~W0290~UNK~UN~UN~POLIO VIRUS, INACT. (IPOL)~2|MMR~MERCK & CO. INC.~0970MU~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~2|MNQ~SANOFI PASTEUR~UB269AA~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|PPV~MERCK & CO. INC.~1197M~UNK~UN~UN~PNEUMO (PNEUMOVAX)~2|TTOX~SANOFI PASTEUR~U0814AA~UNK~UN~UN~TETANUS TOXOID (NO BRAND NAME)~2|TYP~SANOFI PASTEUR~U1203~UNK~UN~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~2|YF~SANOFI PASTEUR~UB3200AA~UNK~UN~UN~YELLOW FEVER (YF-VAX)~2	USA	Disabling	Influenza
0325387	09/17/2008	MD	11.0	11		M	09/17/2008	Extremely severe nasal discharge for 5 days following Flumist.  Bloody nose on and off for 2 days.  Cold progressively worse until 9/12/08.  Body aches, head aches. Dr. office visit - recieved chest x-ray due to severe congestion (negative for pnuemonia). Starting to clear up as of 9/17/08.				Y					U	09/03/2008	09/03/2008	0	Chest x-ray - negative	PVT	PVT	none	none	none			1						1	Chest X-ray normal; Epistaxis; Headache; Nasopharyngitis; Pain; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500545P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0327244	09/17/2008	AL	17.0	17		F	09/15/2008	Information has been received from a healthcare worker from a physician's office concerning a 17 year old female with no medical history and allergic to SULFAMETHOXAZOLE (+) TRIMETHOPRIM (BACTRIM) who on 28-MAR-1996 was vaccinated with a first dose of VARICELLA (Lot# 660495/0431X) and experienced no adverse side effects. On 19-AUG-2008 the patient was vaccinated with a second dose of GARDASIL on the left arm and with a dose of FLUMIST. On 20-AUG-2008, an angioedema developed on her upper right arm where the VARICELLA was administered. At the time of reporting, the patient had not recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.									N	08/19/2008	08/20/2008	1	None	OTH	OTH			Sulfonamide allergy		WAES0808USA04203	1						1	Angioedema	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~~2~UN~LA~HPV (GARDASIL)~1	USA		Influenza
0262657	09/18/2008	CA	18.0	18		M	09/18/2008	FOLLOW UP VAERS (Original VAERS (Original VAERS #262657 filed on 9/6/2006. Updated information attached.  Discharged from the military and lost to follow up.  19 year-old male, retired due to Guillan-Barre syndrome. He presents today for periodic re-evaluation in accordance with orders. He was well until on/about 31 Aug 2006 when he initially-developed achy pain in his arms. Over the next 3 days, he developed rapidly progressive quadriparesis. At nadir, he could not lift his arms over his shoulders and could not walk without assistance. He presented to medical center for evaluation and was diagnosed with Guillain-Barre syndrome. EMG/NCS was consistent with a severe motor-greater-than-sensory mulitfocal peripheral neuropathy, felt-consistent. Early lumbar puncture had normal cell count, with a protein relatively elevated-for-age. He was treated with intravenous immunoglobulin. Subsequently, he had partial improvement in quadriparesis, but continued with moderate-severe distal weakness, so he was medically retired. He reports being at nadir for about 1-2 weeks, then had majority of improvement by Dec 2006. Since Dec 2006 he has continued at his current state. He reports generally feeling well. Seems not to have significant motor weakness. However, he reports a baseline fatigue/tiredness and general decease in energy level which remains functionally-limiting. As a result, he feels he cannot maintain a full-time job.								Y	N	08/29/2006	08/30/2006	1	See attached - abnormal EMG	MIL	MIL	None	None	PCN allergy			1						4	Areflexia; Asthenia; Axonal neuropathy; Blood immunoglobulin M; Blood test normal; Dyskinesia; Electromyogram abnormal; Extensor plantar response; Gait disturbance; Hypoaesthesia; Hypotonia; Immunology test; Lumbar puncture normal; Muscular weakness; Pain in extremity; Paraesthesia; Peripheral sensory neuropathy; Physical examination normal; Areflexia; Asthenia; Babinski reflex test; Culture; Electromyogram abnormal; Gait disturbance; Grip strength decreased; Hypoaesthesia; Hypotonia; Immunology test; Immunology test normal; Joint range of motion decreased; Lumbar puncture normal; Muscular weakness; Neurological examination normal; Neuropathy peripheral; Pain in extremity; Paraesthesia; Polymerase chain reaction; Pulmonary function test; Viral test negative; Asthenia; Blood product transfusion; CSF cell count normal; CSF protein increased; Electromyogram abnormal; Fatigue; Guillain-Barre syndrome; Impaired work ability; Neuropathy peripheral; Pain in extremity; Quadriparesis; Abasia; Areflexia; Asthenia; Axonal neuropathy; Babinski reflex test; Blood product transfusion; CSF culture; Electromyogram abnormal; Gait disturbance; Grip strength decreased; Guillain-Barre syndrome; Hypoaesthesia; Immunology test; Intensive care; Lumbar puncture; Lumbar puncture normal; Muscular weakness; Pain in extremity; Paraesthesia; Peripheral sensorimotor neuropathy; Polymerase chain reaction; Pulmonary function test; Reflexes abnormal; Serology normal	FLUN3~MEDIMMUNE VACCINES, INC.~500430P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|IPV~SANOFI PASTEUR~Y1051~1~SC~RA~POLIO VIRUS, INACT. (IPOL)~2|TDAP~SANOFI PASTEUR~C2457AA~1~IM~RA~TDAP (ADACEL)~2|YF~SANOFI PASTEUR~VEG01A~1~SC~LA~YELLOW FEVER (YF-VAX)~2|FLUN3~MEDIMMUNE VACCINES, INC.~500430P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB061AA~2~IM~LA~HEP A + HEP B (TWINRIX)~3|IPV~SANOFI PASTEUR~Y1051~1~SC~RA~POLIO VIRUS, INACT. (IPOL)~3|TDAP~SANOFI PASTEUR~C2457AA~1~IM~RA~TDAP (ADACEL)~3|YF~SANOFI PASTEUR~VEG01A~1~SC~LA~YELLOW FEVER (YF-VAX)~3|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~4|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~HEP A + HEP B (TWINRIX)~4|IPV~SANOFI PASTEUR~~UNK~UN~UN~POLIO VIRUS, INACT. (IPOL)~4|TDAP~SANOFI PASTEUR~~UNK~UN~UN~TDAP (ADACEL)~4|YF~SANOFI PASTEUR~~UNK~UN~UN~YELLOW FEVER (YF-VAX)~4|FLUN3~MEDIMMUNE VACCINES, INC.~500430P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~5|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB061AA~2~IM~LA~HEP A + HEP B (TWINRIX)~5|IPV~SANOFI PASTEUR~Y1051~1~SC~RA~POLIO VIRUS, INACT. (IPOL)~5|TDAP~SANOFI PASTEUR~C2457AA~1~IM~RA~TDAP (ADACEL)~5|YF~SANOFI PASTEUR~VEG01A~1~SC~LA~YELLOW FEVER (YF-VAX)~5	USA	Disabling	Influenza
0325526	09/18/2008	OR	53.0	53		F	09/18/2008	Pt received influenza vaccine at PCP office. 1 hour after vaccination, (B) LE weakness developed and progressively worsened on 9/11/08. On 9/12/08, the pt was seen at a clinic and referred to the ER for further eval. Pt came in to ER on 9/14/08 w/ continued (B) LE weakness. Neurological evaluation revealed probable Guillain-Barre syndrome w/ IVIG treatment.9/22/08-records received for DOS-9/14-9/18/08-DC DX: Lower extremity weakness, presumably, possibly Guillain-Barre syndrome status post IVIG treatment. CSF showed cyoalbuminologic dissociation. Strength improved discharged to home. Presented to ED with C/O weakness that began 4 days prior. Abrupt onset and constant, right and left leg and foot weakness. Weakness began same day as receipt of flu shot. Upper respiratory infection one month prior that lasted 2-3 weeks. Difficulty walking.				Y	Y	4			U	09/11/2008	09/11/2008	0	CT and MRI of lumbar/thoracic spine - no findings that would explain symptoms; CSF protein 61; (-) spinal culture; CSF albumin cnt 41.6  9/22/08-records received-CT lumbar spine showed degenerative changes at L3, L4. MRI of thoracolumbar spine showed degenerative changes of lumbar spine. CSF slowed cytoalbuminologic dissociation with protein of 61. IgG 1010. CSF albumin 41.6. CSF culture negative. ESR 19.	PVT	OTH	Soma, Gabapentin, Atenolol, Risperdal, Bupropion, Clonazepam, Temazepam, methadone		Chronic low back pain, neuropathic pain of (R) UE from history of DVT, HTN, Depression with anger issues, mild asthma 9/22/08-records received-PMH:chronic low back pain on methadone. Hypertension. Deprssion with anger issues. Asthma. Right upper extremity DVT.			1						1	Albumin CSF decreased; Blood product transfusion; CSF culture negative; CSF protein increased; Guillain-Barre syndrome; Muscular weakness	FLU3~SANOFI PASTEUR~U2772AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0325540	09/18/2008	TX	33.0	33		F	09/18/2008	swelling, fever, a cyst like knot formed where the injection was given.  Rash									Y	09/16/2008	09/16/2008	0		PVT	UNK						1						1	Injection site cyst; Injection site induration; Pyrexia; Rash; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0325541	09/18/2008	WI	4.0	4		M	09/18/2008	child recieved flumist intranasally, followed by ipv (im) in left arm and mmr (sq) in right arm. Child seemed fine, dressed and ran out into waiting room to get stickers. bent over to look at stickers,clutched abdomen and began crying loudly complaining of stomachache. mom took him back into exam room where he continued crying and gripping his chest/abdomen.  i was called into room about 5 minutes after symptoms began. he was nauseous and in obvious significant pain, crying and holding mid epigastric area.  bp 110/64 (baseline for him) pulse ox 99% and heart rate 108.  He had two emeses, non-bilious,no blood. No diarrhea. afebrile. lungs clear. no hives. given zyrtec 15 mg and orapred 22mg with some coaxing. symptoms resoved in about 45 minutes and child was back to baseline in about an hour after symptoms began.  He has no known food or medication allergies.  he had mmr and ipv without adverse events in the past.  On october 27, 2006 he was seen in the office with painless swelling and erythema distal to injection site after recieving the aventis influenza vaccine lot #u2212aa  on 10/25/06.  this was deemed to be a local reaction to the vaccine.										09/16/2008	09/16/2008	0		UNK	UNK	none	mild upper respiratory illness left serous otitis media	seasonal allergic rhinitis.constipation	local redness and swelling~Influenza (Seasonal) (Fluzone)~1~2.30~In Patient		1						1	Abdominal pain upper; Blood pressure normal; Crying; Heart rate increased; Nausea; Oxygen saturation normal; Pain; Reaction to previous exposure to any vaccine; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500551p~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~a0836~4~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1119x~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0325602	09/19/2008	AL	42.0	42		F	04/30/2008	My 4th anthrax booster was given on 17 Oct 2007 upon my return from one country to another. On 2 Nov 2007, 16 days later, I experienced a cardiac event (SVT). The only thing now in my system when asked by doctors what I had different, was the booster. I have no history of heart ailments. The SVT was a one time event. 9/24/08-records received-11/2/07 C/O dizziness, palpitations, chest tightness. Diagnosed with SVT.  MI ruled out. Office visit 2/27/08-C/O coughing, congestion and runny nose, post nasal drip and sore throat times 1 week.				Y	Y	6			Y	10/17/2007	11/02/2007	16	9/24/08-records received- Myocardial perfusion stress test-no scintigraphic evidence of ischemia or infarct. Cardiac enzyme elevation.	MIL	MIL	Anti malaise (weekly), DIOVAN, ORTHO NOVUM 777		9/24/08-records received-PMH:Hypertension.			1						1	Supraventricular tachycardia	ANTH~EMERGENT BIOSOLUTIONS~FAV113~4~UN~UN~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500485P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB403AA~UNK~UN~UN~HEP B (ENGERIX-B)~1	USA	Hospitalisation	Influenza
0325629	09/19/2008	WA	66.0	66		F	09/19/2008	Fluzone/Pneumovax administered Saturday.  Patient in bed Sunday, couldn't get up, achy, 99.0 fever.  Monday afternoon felt fine.									Y	09/13/2008	09/14/2008	1		OTH	PUB		None				1						1	Activities of daily living impaired; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0619X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0325630	09/19/2008	GA	2.0	2	.9	M	09/19/2008	Within an hour of receiving Flu Mist vaccine yesterday, patient had a high fever (104) with shaking (chills?). We gave him Tylenol at 4:45, 8:15, and 4:15am. He had the high fever for 12-15 hours. It seems to have broken now, and he seems to be feeling better. Additional symptoms included general discomfort, shaking, runny nose, glassy eyes. All symptoms have now subsided.									Y	09/18/2008	09/18/2008	0	none	UNK	UNK	none	No	Childhood apraxia			1						1	Discomfort; Eye disorder; Pyrexia; Rhinorrhoea; Tremor	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0325646	09/19/2008	MA	40.0	40		F	09/19/2008	c/o pain at injection site and redness day after injection. The next day it was warm to touch with a 4cm x 4.6cm area of redness, was placed on Benadryl 25mg and Pandel cream 0.1%. The next day the redness had decreased and was not as painful.									Y	09/16/2008	09/17/2008	1		PVT	UNK	Levoxyl	none	allergy to erythromycin			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U2762AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0325668	09/19/2008	CA	81.0	81		F	09/19/2008	Pt developed a full body non-puritic rash (pink macule of different sizes)									U	09/18/2008	09/18/2008	0	None	UNK	PVT	Olmesartan Medoxomil-Hydrochlorothiazide (BENICAR HCT) Omeprazole Cap Delayed Release (PRILOSEC) Olmesartan Medoxomil (BENICAR) Calcium Carbonate-Vitamin D (CALCIUM 500/D) Aspirin (ASPIRIN) Acetaminophen (TYLENOL EXTRA STRENGTH)	None	Edema, Osteoarthros, Hypertension			1						1	Rash erythematous; Rash generalised; Rash macular	FLU3~SANOFI PASTEUR~U27428A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0325688	09/19/2008	MN	1.3	1	.3	F	09/18/2008	Developed fine pinpoint viral appearing rash a few weeks after receiving vaccines- no fever or other symptoms									Y	09/18/2008	09/18/2008	0		PVT	PVT						1						1	Viral skin infection	FLU3~SANOFI PASTEUR~UT2782AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB245AA~UNK~IM~LL~HEP A (HAVRIX)~1	USA		Influenza
0316501	09/22/2008	IL	19.0			M	09/16/2008	This case was reported to the Centers for Disease Control and Prevention (CDC) by a health professional. The case was received from the CDC on 15 September 2008. A 19-year-old male patient received the following vaccines on 14 March 2008: a right arm injection of ADACEL (lot number C2864AA), a left arm intramuscular injection of MENACTRA (lot number U2570AA), an intramuscular right arm injection of INFLUENZA (GlaxoSmithKline, lot number AFLLA050AA), an intramuscular left arm injection of HEP A and B (GlaxoSmithKline, lot number AHABB108AA), and a subcutaneous left arm injection of MMR (Merck, lot number 1311U). At the time of vaccination, the patient had a three-week history of upper respiratory infection with cough, nasal congestion, rhinorrhea, and yellow sputum. He was taking Bicillin concomitantly. On 19 April 2008, 36 days after vaccination, he presented with numbness in both legs, hand balancing problem, sensory changes, numbness of the abdomen, muscular weakness, and one loose stool. He was admitted to the hospital on 26 April 2008, where a physical exam revealed decreased deep tendon reflexes. A lumbar puncture revealed increased protein of 297.1, WBC 12.8, lymphocytes 90%, and monocytes 10%. No organisms were seen on culture. EMG showed a conduction block and mild prolongation of latency, suggestive of acute demyelinating neuropathy. MRI of the brain and cervical spine were unremarkable. He was treated with IVIG, and subsequently transferred to a rehabilitation facility. His stay was complicated by left facial palsy on 04 May 2008. He was discharged from the hospital on 09 May 2008. Outcome was not reported.					Y	13				03/14/2008	04/19/2008	36	A lumbar puncture revealed increased protein of 297.1, WBC 12.8, lymphocytes 90%, and monocytes 10%. No organisms were seen on culture. EMG showed a conduction block and mild prolongation of latency, suggestive of acute demyelinating neuropathy. MRI of the brain and cervical spine were unremakable	UNK	UNK	Bicillin		History of upper respiratory infection for three weeks with cough, yellow sputum, runny nose, and congestion.  No pre-existing conditions.		200802881	1						2	Areflexia; Asthenia; Dysaesthesia; Gait disturbance; Hyperaesthesia; Hypoaesthesia; Nervous system disorder; Paraesthesia; Peripheral sensory neuropathy; Balance disorder; Blood product transfusion; CSF culture negative; CSF lymphocyte count increased; CSF monocyte count decreased; CSF protein increased; CSF white blood cell count increased; Diarrhoea; Electromyogram abnormal; Facial palsy; Hypoaesthesia; Hyporeflexia; Lumbar puncture abnormal; Muscular weakness; Nuclear magnetic resonance imaging brain normal; Nuclear magnetic resonance imaging normal; Sensory disturbance	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA050AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB108AA~1~IM~LA~HEP A + HEP B (TWINRIX)~1|MMR~MERCK & CO. INC.~1311U~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|MNQ~SANOFI PASTEUR~U2570AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2864AA~1~UN~RA~TDAP (ADACEL)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA050AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~2|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB108AA~UNK~IM~LA~HEP A + HEP B (TWINRIX)~2|MMRV~MERCK & CO. INC.~1311U~UNK~SC~LA~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~2|MNQ~SANOFI PASTEUR~U2670A~UNK~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TDAP~SANOFI PASTEUR~C2864A~UNK~UN~RA~TDAP (ADACEL)~2	USA	Hospitalisation	Influenza
0325679	09/22/2008	CA	60.0	60		M	09/22/2008	Inability to use my arms, legs properly - incredible muscular stiffness throughout my body; dry cough; phelgm in my lungs, lost my voice  9/23/08 Reviewed PCP medical record of 9/22/08. FINAL DX: URI, doubt adverse effect of flu shot Record reveals patient experienced muscle stiffness & pain, tired, hoarse voice, wet cough, scratchy throat.  Sick contact at work w/similar symptoms. Symptomatic tx.				Y					N	09/19/2008	09/20/2008	1		UNK	UNK	Cholesterol Medication - Simvistatin	None	None			1						1	Increased upper airway secretion; Mobility decreased; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~V2742AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0325779	09/22/2008	AZ	31.0	31		F	09/22/2008	4 hours after injection, sharp pains in head and neck. 10 hours after injection chills and all over body pain. 18 hours after injection pain is less.									Y	09/21/2008	09/21/2008	0		PUB	PVT						1						1	Chills; Headache; Neck pain; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0325803	09/22/2008	NE	3.0	3		M	09/18/2008	MMR and FLUMIST given.  10 minutes after leaving clinic patient returned with MD sensorium, Injection of eyes, erythema, neck, chest, hives trunk, blister with approximately 2 cm at MMR site.  2 dose 0.2 ml Epi + O2 5L; Benadryl 25 mg x 1: 911 transport ER.				Y					Y	09/18/2008	09/18/2008	0	To ER observation 4 hours, no sequalae.	PVT	UNK		None	None			1						1	Blister; Conjunctival hyperaemia; Depressed level of consciousness; Erythema; Urticaria; Depressed level of consciousness; Erythema; Injection site reaction; Staring; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500544P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~MERCK & CO. INC.~0812X~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500544P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~2|MMR~UNKNOWN MANUFACTURER~0872X~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0325805	09/22/2008	AL	52.0	52		F	09/22/2008	Periabrital edema, ud conjunctive, throat tightness, stating 3 hours after injection.  Prescribed Medimune H1 + H2				Y					Y	09/19/2008	09/19/2008	0	None	PVT	PVT		None	Sulfa; PCN			1						1	Conjunctival hyperaemia; Periorbital oedema	FLU3~SANOFI PASTEUR~U2761AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0325809	09/22/2008	LA	4.0	4		M	09/22/2008	Five vaccines were administered and within 3-5 minutes pt broke out in whelps. Whelps started on face and then covered whole body. Feet were itching and whelps also. Pt complained with tongue itching and lips were swollen. No respiratory distress. Benadryl given I.M. Five minutes after onset of reaction, pt remained for 1 hour in office.									Y	09/18/2008	09/18/2008	0	None	PVT	PVT	Motrin	None	None			1						1	Lip swelling; Pruritus; Urticaria	DTAP~SANOFI PASTEUR~C2934BA~5~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2785HA~5~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0452~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0842X~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0737X~2~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0325813	09/22/2008	OR	2.0	2	.2	M	09/22/2008	Developed hives on trunk of body approximately 4-6 hours post vaccination.  Hives were relieved with Benadryl and lasted approximately 48 hours.									Y	09/18/2008	09/18/2008	0	N/A	PVT	PUB	None known	Rhinorrhea	None			1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0325839	09/23/2008	FL	26.0	26		F	09/23/2008	No adverse events				Y					U	09/18/2008	09/19/2008	1		PVT	OTH		Redness injection site, fever, swollen arm, bump				1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2757AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0669X~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0325840	09/23/2008	FL	17.0	17		M	09/23/2008	Patient received PNEUMOVAX vaccine.  Arm became swollen, warm to touch, down into chest few hours after receiving injection.  Went to ER around 11:00 PM.				Y					Y	09/22/2008	09/22/2008	0		PVT	OTH	Cindamycin 300mg oral capsule 1 tab PO QID; Analapril 5mg PO daily; Vitamin D; Flovent 2 puffs inhaled; Laclulose 30ml PO BID; Asacol 800mg PO BID; Non-formula continuous infusion; Prednisone 20mg PO daily; Alampin 150mg PO daily; Alampin 3		Primary sclerosing cholangitis			1						1	Oedema peripheral; Skin warm; Blood pressure increased; Erythema; Injection site erythema; Injection site swelling; Injection site warmth; Local swelling	FLU3~SANOFI PASTEUR~U2791AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0619X~1~UN~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U2791AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0619X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0325867	09/23/2008	WA	0.5	0	.5	F	09/18/2008	Presented to ER 12-17-07 at 22:59 cough x 2-3 days, loose stools.  Fever 103 at home, 38.7 rectal at ER.  Tylenol every 20 minutes prior to ER temperature.  Diagnosed febrile reaction post vaccination and diarrhea.  12-20-07 19:30 to ER, 102 fever, pulling at ears.  UA #.  Diagnosed acute otitis media, fever after 12's?  Treatment Augmentin.				Y					Y	12/17/2007	12/17/2007	0	UA: #	PVT	PUB	Tylenol prior to 12's	Not discussed at O.V. at hospital.  Stated URI x 2-3 days at ER.	None			1						1	Cough; Diarrhoea; Immunisation reaction; Otitis media acute; Pyrexia; Urine analysis	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B130AA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2477DA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF215AB~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C65046~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0325874	09/23/2008	PA	51.0	51		F	09/18/2008	Received shot at 3:45pm.  At approximately 6:45pm started shaking, muscles and joints started aching; became nauseated, got severe fever - could barely stand up - shaking uncontrollably for several hours.  At about 5:00am, started sweating for 2 solid hours - totally drenched!  Back hurt for 48 hours.  Did not go to emergency as husband was at work and I kept thinking it would pass.									Y	09/15/2008	09/15/2008	0		OTH	OTH	None	None	None			1						1	Arthralgia; Back pain; Dysstasia; Hyperhidrosis; Myalgia; Nausea; Pyrexia; Tremor	FLU3~CSL LIMITED~01049211A~UNK~~~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0325883	09/23/2008	FL	25.0	25		M	09/23/2008	5 min after receiving flu mist, pt went unconscience for aprox 45 sec. due to vasovagal episode.  Pt was given O2 and fully recovered.									Y	09/22/2008	09/22/2008	0		MIL	MIL						1						1	Loss of consciousness; Syncope vasovagal	FLUN3~MEDIMMUNE VACCINES, INC.~500552P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0325884	09/23/2008	MA	5.0	5		M	09/23/2008	Fever, chills, nocturnal enuresis within 12 hours of flumist									Y	09/22/2008	09/23/2008	1	None	PVT	PVT	None	None	Hx of recurrent infection			1						1	Chills; Enuresis; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500543P~6~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0325888	09/23/2008	UT	2.0	2	.0	M	09/23/2008	Redness, Swelling, Hot to touch. Celluitis was put on Augmentin 400/5.				Y						09/22/2008	09/23/2008	1		PVT	PVT						1						1	Cellulitis; Erythema; Skin warm; Swelling	FLU3~SANOFI PASTEUR~UT2782CA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AAAHAVB5~2~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1119X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0325896	09/23/2008	CA	63.0	63		F	09/23/2008	Patient c/o chills, fever and aching for 3 days,  Left arm at site of injection became red swollen and painful.  Patient called after 3 days and stated the symptoms were all subsiding.									Y	09/19/2008	09/19/2008	0	None	PVT	PVT	Estradiol, Folic Acid, Divan/HCT,Zocor, Levoral, Cosamine, Nasacort, Ostelin	None known	None known			1						1	Chills; Injection site erythema; Injection site pain; Injection site swelling; Pain; Pyrexia	FLU3~CSL LIMITED~00849211A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|MEN~SANOFI PASTEUR~UF2245AC~1~SC~LA~MENINGOCOCCAL (MENOMUNE)~1|PPV~MERCK & CO. INC.~02000~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0325907	09/23/2008	GA	16.0	16		F	09/23/2008	Cramping at site of HPV vaccine then fainting.  Pale, low pulse.  Alert by time we entered room less than 1 minute.  Able to walk out of office in 10 minutes, alert, good color, good pulse and blood pressure.									Y	09/22/2008	09/22/2008	0	None	PVT	PVT	Advil	None - well child check	History asthma			1						1	Heart rate decreased; Injection site pain; Muscle spasms; Pallor; Syncope	FLU3~SANOFI PASTEUR~U2762AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB289AP~2~UN~LA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~0229X~1~IM~LL~HPV (GARDASIL)~1|TDAP~SANOFI PASTEUR~C2998BA~UNK~IM~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~0273X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0325908	09/23/2008	VA	4.0	4		M	09/23/2008	Arm became red and swollen from elbow to shoulder, tight, tense skin, itchy, painful.				Y						09/22/2008	09/23/2008	1	None	PVT	PVT		None	None			1						1	Erythema; Oedema peripheral; Pain; Pruritus; Skin tightness	FLU3~SANOFI PASTEUR~U2772AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0325911	09/23/2008	PA	1.0	1	.0	F	09/23/2008	Evening of vaccine. Went to bed as normal. Awoke stiff, blue and eyes rolling into back of her head. Lasted 2. Went to ED by ambulance. By the time at ED noted to have fever. Thought to have febrile seizure due to vaccines.				Y					Y	09/18/2008	09/18/2008	0		PVT	PVT		None	Atopic dermatitis (eczema)			1						1	Cyanosis; Febrile convulsion; Gaze palsy; Immunisation reaction; Musculoskeletal stiffness; Pyrexia	FLU3~SANOFI PASTEUR~U2762AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB297AA~1~UN~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1082X~1~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0997X~1~UN~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0326008	09/24/2008	FL	20.0	20		F	09/24/2008	shortness of breath, dizziness				Y					Y	09/18/2008	09/18/2008	0	EKG- within normal limits; CBC- within normal limits; BMP- Carbon Dioxide 20, Blood Chloride 108	PUB	PUB	none known	none known	none known			1						1	Blood chloride increased; Carbon dioxide decreased; Dizziness; Dyspnoea; Electrocardiogram normal; Full blood count normal; Metabolic function test	FLU3~CSL LIMITED~01949111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0326009	09/24/2008	FL	23.0	23		F	09/24/2008	Chest pressure, lightheadedness, jittery feeling.				Y					Y	09/23/2008	09/23/2008	0	EKG- within normal limits; pulse ox- 99%; CBC- Neut 75.8, Lymph 16.2, Ne 8.2, Mo 0.7; BMP- Potassium 3.6; Troponin- negative	PVT	PVT	no known	no known	no known	Leg paralyisis~ ()~UN~5.00~In Patient		1						1	Blood potassium normal; Chest discomfort; Dizziness; Electrocardiogram normal; Feeling jittery; Full blood count; Lymphocyte percentage decreased; Metabolic function test; Monocyte percentage; Neutrophil count increased; Neutrophil percentage increased; Oxygen saturation normal; Troponin	FLU3~CSL LIMITED~01949111A~4~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0326010	09/24/2008	CA	39.0	39		F	09/24/2008	Three days after the vaccine, onset of dizziness, headache and light headed with muscle aches.  Sinus pain.									U	09/19/2008	09/22/2008	3	none yet	PUB	PUB	Wellbutrin, sudafed, allegra	none	depression, allergic rhinitis			1						1	Dizziness; Headache; Myalgia; Sinus headache	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0326011	09/24/2008	FL	22.0	22		F	09/24/2008	sharp, midsternal pain, worse with inspiration and movement, shortness of breath				Y					Y	09/17/2008	09/17/2008	0	none	PVT	PVT	none known	none	none known			1						1	Chest pain; Dyspnoea	FLU3~CSL LIMITED~01949111A~2~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0326012	09/24/2008	HI	38.0	38		U	09/24/2008	patient reported feeling lightheaded several hours after receiving the pneumococcal vaccine on 9/18/08 and experienced a syncopal episode with a fall upon arising from bed ---> sustained a nasal fracture and contusion to left knee and strain of LS spine				Y					Y	09/18/2008	09/18/2008	0	xray of nose 9/19/08 at ER --> non-displaced fracture of distal tip of the nasal bone	UNK	UNK	Etodolac, Lexapro, Ortho-Cept	no acute illness at time of vaccination	ankylosing spondylitis, depression; allergies to Remiciade --> SOB, Flagyl--> enlarged lymph nodes, sulfasalazine --> photosensitivity			1						1	Back injury; Contusion; Dizziness; Face and mouth X-ray abnormal; Facial bones fracture; Fall; Syncope	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA184AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1383U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0326015	09/24/2008	HI	57.0	57		F	09/24/2008	On thursday Sept 18, 2008 around noon, recieved flu shot to L deltoid continued to work.   Approx 9:00pm rash appeared first on hands then chest migrating to the neck and face.Took Allegra D at approx 10:00 pm at 10:30 relief was noted										09/18/2008	09/18/2008	0		PVT	UNK	AllegraD, Zyzaar,Atenol, Astos, Metphormen, Glippezine,Lipitor, Levestosin	None	Iodine			1						1	Rash generalised; Rash generalised	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFUA364BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFUA364BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA		Influenza
0326015	09/24/2008	HI	57.0	57		F	09/24/2008	After receiving the flu shot to the left arm around noon on the 18th of Sept. Patient finished her shift and went home. Approx 9pm a rash appeared on her hands spreading to her chest neck and face. She took her Allegra D in approx 1/2 hour she felt relief.									Y	09/18/2008	09/18/2008	0		UNK	UNK	Allegra D, ZyZaar,Atenol,Astos, Glippezine,Lipitor, Levestrostine, Metphormen	None	Iodine			1						2	Rash generalised; Rash generalised	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFUA364BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFUA364BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA		Influenza
0326022	09/24/2008	WA	46.0	46		F	09/24/2008	Patient became dizzy and disoriented approximately 12 hours after receiving vaccine.  She fainted and hit her head.									Y	09/23/2008	09/24/2008	1	Patient may be pregnant (doesn't know).	OTH	UNK						1						1	Disorientation; Dizziness; Head injury; Syncope	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA366CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0326023	09/24/2008	AZ	60.0	60		F	09/24/2008	Patient received flu shot on 9/22/08.  When she went home, she developed vomiting, nausea and dark colored diarrhea.  No treatment given as yet.									U	09/22/2008	09/22/2008	0	None	PVT	PVT	None	Unknown	Hepatitis C			1						1	Diarrhoea; Faeces discoloured; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U2751AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326024	09/24/2008	AZ	71.0	71		M	09/24/2008	Pt received flu shot on 9/22/08. He went home directly thereafter and developed vomiting, nausea, diarrhea and fever									U	09/22/2008	09/22/2008	0	None	PVT	PVT	None	Unknown	Hepatitis C			1						1	Diarrhoea; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2751AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326027	09/24/2008	TX	26.0	26		M	09/19/2008	After receiving Anthrax, patient noted redness, swelling, itching in the area on 18 Sept 08.  Area is 11 x 11cm, faint erythema, mild tenderness at vaccine site.  Was given Zyrtec and Motrin.									U	09/17/2008	09/18/2008	1	N/A	MIL	MIL	N/A	N/A	Allergic to PCN			1						1	Injection site erythema; Injection site pain; Local swelling; Pruritus; Red blood cell abnormality	ANTH~EMERGENT BIOSOLUTIONS~FAV149~4~~LA~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500559P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0326035	09/24/2008	PA	18.0	18		M	09/24/2008	Patient stated evening after vaccines - rash started.  Seen in office 9/24/08 for worsening rash - hives.  No signs of anaphylaxis - patient placed on Benadryl around the clock for 48 hours - if worsening to call.									U	09/22/2008	09/22/2008	0		PVT	PVT	None	None	None			1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~U2780BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2995BA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0327517	09/24/2008	NY				U	09/05/2008	This case was reported by a physician, via a GSK sales representative, that described the occurrence of arthralgia in a subject of unspecified age and gender, who was vaccinated with influenza virus vaccine (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of Flu vaccine (unknown). At an unspecified time after vaccination with Flu vaccine, the subject experienced severe arthralgia. A physician reported to a sales representative that the subject experienced severe arthralgia that required treatment with Prednisone after receiving a flu vaccine. The reporting representative had limited information and was not certain that the flu vaccine received was FLUARIX. At the time of reporting, the outcome of the event was unspecified.									U				Unknown	PVT	OTH		Unknown	The subject's medical history, history of adverse events following previous vaccinations, and concomitant medications were not reported.		A0735886A	1						1	Arthralgia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0327518	09/24/2008	AL	8.0	8		M	09/05/2008	This Case was reported by the mother of a consumer and described the occurrence of skin reactions (dermatological reaction) in an 8-year-old male subject who was vaccinated with influenza virus vaccine (flu vaccine, Glaxosmithkline). A physician or other health care professional has not verified this report. Concurrent medications included multivitamins. On 30 October 2006, in the afternoon, the subject received unspecified dose of flu vaccine at .25ml in an unknown arm. Two to four weeks after vaccination with flu vaccine, the subject developed what the mother referred to as a Dermatological reaction (skin reactions). A systemic reaction. He developed lesions (described as a nummular) on his hand, wrist, arms and the back of the ankles. It had been called eczema as well as some other Unidentifiable term (spongia). The condition responds to steroids, but when they are stopped the symptoms return. The subject has also been treated with Mupirocin and this worsened the lesions. The child has reportedly seen several dermatologists as well as allergists. He was tested for everything and it all comes back negative. The first flu vaccine the subject ever received was by Aventis and he ended up with over 300 lesions. At the time of reporting the outcome of the events was was unspecified. This was also considered to be a medication error as Glaxosmithkline flu vaccine in not indicated for use in pediatric subjects. These events occurred again in this subject in 2007 following vaccination with a Glaxosmithkline flu vaccine. Refer to case number A0739862A for details surrounding the second report.									U	10/30/2006	10/30/2006	0	Unspecified allergy testing came back negative, including a test for egg allergy.	MIL	OTH	Multivitamin	Unknown	The subject has no history of allergies. The subject experienced the same events following administration of Aventis's flu shot (1st flu shot given to the subject). He had over 300 lesions at that time.		A0739853A	1						1	Allergy test negative; Eczema; Inappropriate schedule of drug administration; Skin lesion; Skin reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0327519	09/24/2008	AL	9.0	9		M	09/05/2008	Skin reaction, Medication error, Nonspecific reaction, Skin lesion. Eczema, Adverse event. This case was reported by the mother of a consumer and described the occurrence of skin reactions (dermatological reaction) in a 9 year old male subject who was vaccinated with influenza virus vaccine (flu vaccine, Glaxosmithkline) for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medications included Multivitamins. On 22-October- 2007, in the afternoon, the subject received unspecified dose of Flu vaccine, the subject developed what the mother referred to as a dermatological reaction (skin reaction). A systemic reaction. He developed lesions (described as nummular) on his hands, wrists, arms and the back of the ankles. It had been called eczema as well as some other unidentifiable term (spngia). The condition has lasted for about 8 months as of the time of reporting and the mother did report that there was only one lesion left. The condition responds to steroids, but when they are stopped the symptoms return. The subject has also been treated with mupirocin (clay park labs) and this worsened the lesions. The child has reportedly seen several dermatologists as well as allergist. Hwas tested for everything and it all comes back negative. the first flu vaccine the subject ever recieved was by aventis and he ended up with over 300 lesions. at the time of reporting the outcome of the events were unspecified. This was also considered to be a medication error as Glaxosmithkline flu vaccine is not indicated for use in pediatric subjects. These events occurred in this subject in 2006 following vaccianition with a Glaxosmithkline flu vaccine. Refer to case number A0739B53A for details surrounding the first report.									U	10/22/2007			Unspecified allergy testing came back negative, Including a test egg allergy.	MIL	OTH	Multivitamin	Unknown	The subject has no history of allergies. The subject experienced the same events following administration of Aventis's Flu shot (1st flu shot given to the subject). He had over 300 lesion at that time. These events occurred in this subject in 2006 following vaccination with a Glaxosmithkline flu vaccine. Refer to case number A0739853A for details Surrounding the first report.		A0739862A	1						1	Allergy test negative; Eczema; Inappropriate schedule of drug administration; Skin lesion; Skin reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0325840	09/25/2008	FL	17.0	17		M	09/25/2008	Pt rcvd pneumococcal vaccine in L deltoid and influenza vaccine in right deltoid.  12 hours later pt arrived in ER with large injection site reaction on left arm with redness and swelling that went down onto the chest.  Area warm to touch. Pt BP elevated.  Pt rcvd IV antibiotics and discharged with oral antibiotics.  Pt to increase current prednisone dose from 20mg to 40mg for 1 day, then 30mg x 1 then back to 20 mg maintanance dose.				Y					Y	09/22/2008	09/22/2008	0		PVT	PVT	prednisone 20mg daily, insulin pump, rifampin 450mg daily, enalapril 5 mg daily, flovent, ursodiol 1000mg daily, Asacol 800mg BID, vitamin D, lactulose 30 mL BID	primary sclerosing cholangitis, with possible autoimmune hepatitis; diabetes mellitus	primary sclerosing cholangitis, with possible autoimmune hepatitis; diabetes mellitus; proteinuria.  Being evaluated for liver & pancrease transplant.			1						2	Oedema peripheral; Skin warm; Blood pressure increased; Erythema; Injection site erythema; Injection site swelling; Injection site warmth; Local swelling	FLU3~SANOFI PASTEUR~U2791AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0619X~1~UN~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U2791AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0619X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0326096	09/25/2008		32.0	32		F	09/24/2008	Information has been received from a registered nurse concerning a 32 year old female with a positive TB skin test, and no drug reactions or allergies, who on 29 OCT 2007 was vaccinated with a second dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (Lot # 652320/0092F). The patient had received a first dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) on 07-AUG-2007, while out of the country. The patient's husband reported to the nurse that the patient is now pregnant. The patient's LMP was 10 OCT 2007. Other vaccine therapy on 29 OCT 2007 included poliovirus vaccine, hepatitis B virus vaccine rHBsAg (manufacturer unknown), and influenza virus vaccine (unspecified). Follow-up information has been received through the Merck pregnancy registry from a registered nurse concerning this 32 year old female with no known drug allergies and a positive tuberculosis skin test who on 29-OCT-2007 was vaccinated with a second dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (Lot # 652320/0092F). The patient received the first dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) on 07-AUG-2007, while out of the country. Other concomitant vaccinations on the same day included hepatitis B virus vaccine rHBsAg (manufacturer unknown), poliovirus vaccine inactivated (unspecified) (manufacturer unknown), influenza virus vaccine (unspecified) (manufacturer unknown) and diphtheria toxoid/tetanus toxoid (manufacturer unknown). The patient also had a tuberculosis skin test performed. It was noted that the patient delivered a female child on 05-JUL-2008. At 3 weeks old (on approximately 26-JUL-2008) the baby was hospitalized with meningitis for 3 weeks. The baby survived. At the time of the report, the baby's status was unknown. The nurse reported that she does not have all the medical details at this time, the family was traveling out of the country. Upon internal review the baby's meningitis was considered an other important medical event. Additional information has been requested.				Y	Y	0			Y	10/29/2007	10/29/2007	0	tuberculin skin test, 10/29/07	OTH	OTH		Pregnancy NOS (LMP = 10/10/2007); Tuberculosis skin test positive			WAES0712USA02838	1						1	Drug exposure during pregnancy; Foetal disorder; Tuberculin test	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~MERCK & CO. INC.~~UNK~UN~UN~HEP B (RECOMBIVAX HB)~1|IPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~0092F~2~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|TD~UNKNOWN MANUFACTURER~~UNK~UN~UN~TD ADSORBED (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0326106	09/25/2008	NY	9.0	9		M	09/22/2008	FLUZONE given 9/9/08. Had lice 9/15/08. Treated with NIX and homeopathic oils. Developed rash seen 9/19 (+) petechiae, bruising, platelet ct = 12. Admit Monday to hospital. Given Win-Rho suspect ITP.  11/26/08 MR received for DOS 9/19-20/2008 with DX: ITP. Pt presented with 1 wk hx of bruising with more recent addition of petechiae and purpura.  Platelet count of 12K at PMD's office.  Admitted for WinRho tx of thrombocytopenia.  Platelet count up to 35K prior to d/c. Will f/u as outpt.					Y	2			Y	09/09/2008	09/18/2008	9	WBC, 7.2; HgB, 14; Platelet count, 12; 40 L; 8 M; 51 GR; nl PT/PTT; (-) blood cx . Labs and Diagnostics:  Platelet counts 12K, 16K, up to 35K after WinRho. Coags WNL. Alk Phos 149.  ANA (-).	PVT	PVT		None	None. PMH: Asthma, recent lice, impetigo. NKDA			1						1	Activated partial thromboplastin time normal; Blood culture negative; Contusion; Granulocyte count decreased; Haemoglobin normal; Idiopathic thrombocytopenic purpura; Lice infestation; Lymphocyte percentage; Monocyte percentage; Petechiae; Platelet count decreased; Prothrombin time normal; Rash; White blood cell count normal	FLU3~SANOFI PASTEUR~U2786AA~6~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0326179	09/25/2008	WI	5.0	5		M	09/25/2008	30 minutes after leaving our office after receiving immunizations at his well child check, patient returned with mother. At the time of return he was flushed with hives present; eyelids, tongue, and lips swollen; pt was having difficulty swallowing; decreased responsiveness (eyes open but not talking).  911 called. Tachycardic on exam by Dr.  Respiratory rate normal. Epi-pen Jr administered to left thigh. Oxygen saturation was 96-98%.  Paramedics arrived with in 5 minutes and patient was transported to hospital in stable condition for further evaluation and treatment.				Y					Y	09/24/2008	09/24/2008	0		UNK	UNK						1						1	Depressed level of consciousness; Dysphagia; Eyelid oedema; Flushing; Lip swelling; Oxygen saturation normal; Respiratory rate; Swollen tongue; Tachycardia; Urticaria; Drug hypersensitivity; Dysphagia; Eyelid oedema; Flushing; Hypokinesia; Lip swelling; Swollen tongue; Tachycardia; Urticaria; Depressed level of consciousness; Dysphagia; Eyelid oedema; Flushing; Lip swelling; Oxygen saturation normal; Respiratory rate; Swollen tongue; Tachycardia; Urticaria	DTAP~SANOFI PASTEUR~C2956AA~5~IM~LA~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500545P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~A0836~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1119X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1002X~2~SC~LA~VARICELLA (VARIVAX)~1|DTAP~SANOFI PASTEUR~C2956AA~5~IM~LA~DTAP (DAPTACEL)~2|FLUN3~MEDIMMUNE VACCINES, INC.~50054P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|IPV~SANOFI PASTEUR~A0836~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~2|MMR~MERCK & CO. INC.~1119X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~2|VARCEL~MERCK & CO. INC.~1002X~2~SC~LA~VARICELLA (VARIVAX)~2|DTAP~SANOFI PASTEUR~C2956AA~5~IM~LA~DTAP (DAPTACEL)~3|FLUN3~MEDIMMUNE VACCINES, INC.~500545P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3|IPV~SANOFI PASTEUR~A0836~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~3|MMR~MERCK & CO. INC.~1119X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~3|VARCEL~MERCK & CO. INC.~1002X~2~SC~LA~VARICELLA (VARIVAX)~3	USA	Emergency room visit	Influenza
0326180	09/25/2008	GA	39.0	39		F	09/25/2008	Approx one hour after receiving the flu vaccine, she noticed body itching, hot feeling. light headed.  After two hours, developed hives on left arm which was the arm of vaccination. Saw Dr. who recommended antihistamine. Pt took Benadryl. Felt better. Next day, still improving.									Y	09/24/2008	09/24/2008	0		UNK	UNK			CIPRO			1						1	Dizziness; Feeling hot; Pruritus generalised; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA349CD~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0326186	09/25/2008	VA		21		F	09/25/2008	About two hours following vaccine administration feels hot, dizzy, faint, confuseddenies SOB				Y					U	09/25/2008	09/25/2008	0		PVT	PVT		no	none known			1						1	Confusional state; Dizziness; Dyspnoea; Feeling hot	FLUN3~MEDIMMUNE VACCINES, INC.~500545P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0326190	09/25/2008	MI	28.0	28		F	09/25/2008	Pt returned to the office 1 hour after the injection with a rash at the site of injection. Rash extended from wrist to shoulder on the left arm.									U	09/25/2008	09/25/2008	0	N/A	PVT	PVT	Albuterol inhailer	URI	N/A			1						1	Injection site rash; Rash	FLU3~CSL LIMITED~0124911a~1~ID~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~1384u~1~ID~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0326196	09/25/2008	FL	26.0	26		F	09/25/2008	30 min after receiving vaccine, pt stated she had nausea and vomiting.  pt was given medication to help with nausea.									Y	09/25/2008	09/25/2008	0	negative HCG test	MIL	MIL	none	none	none			1						1	Nausea; Pregnancy test negative; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500552p~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0326201	09/25/2008	CA	47.0	47		M	09/25/2008	Severe flu-like symptoms starting at 12M including high fever (103), chills, severe aching; Fever down to 101 at 5AM; took aspirin after calling emergency room; fever down to 100 at 6AM; fever and flu like symptoms thru 9/25/08 evening.									Y	09/24/2008	09/25/2008	1		UNK	UNK	Albuteral	None	None			1						1	Chills; Influenza like illness; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0326206	09/25/2008	VA	79.0	79		F	09/24/2008	Patient presented to the pharmacy complaining of redness, swelling (very well demarcated) and injection site tenderness (upon touch).  Patient has not seeked medical attention thus far.									U	09/23/2008	09/24/2008	1		OTH	PVT		None	Unknown			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0326207	09/25/2008	GA	2.0	2	1	M		Fever, vomiting overnight on 9-24-08.									Y	09/24/2008	09/24/2008	0		PVT	UNK						1						1	Pyrexia; Vomiting	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B051AA~5~IM~UN~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2762AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB239AA~1~IM~UN~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~A08362~3~IM~UN~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0326209	09/25/2008	KS	21.0	21		F	09/25/2008	Pt had FLUMIST and SPV (left arm) on 9/2/08 and anthrax #3 on 9/3/08.  Pt states that on 9/2/08 she started having left arm pain, and she noted a swollen lymph node on the left side of her neck and her left axilla.  She also had pain in these areas.  On 9/6/08 she started having left arm and hand numbness (intermittent).  On the nite of 9/6/08 she had chest pressure (6/10) which increased with lying down and improved with sitting up.  The pt denied having SOB, but did say that she felt anxious and could feel her heart pounding.  The chest pain lasted 48 hours.  The pt went to the ER on 9/11/08 and was told that she was released to full duty.				Y					U	09/02/2008	09/02/2008	0	11 Sep 2008, Troponin I Cardiac PLASMA, 0.012 ng/mL; Creatine Kinase MB PLASMA, 0.3 ng/mL; 11 Sep 2008, BNP Blood, 10.8 pg/mL; 11 Sep 2008, INR PLASMA, 0.99; Protime PLASMA, 11.55 sec; 11 Sep 2008, APTT PLASMA, 28.70 sec; Creatine Kinase SERUM, 61 U/L; 11 Sep 2008, Glucose Fasting SERUM, 119 (H) mg/dL; Urea Nitrogen SERUM, 10 mg/dL; Creatinine SERUM, 0.7 mg/dL; Urate SERUM, 3.8 mg/dL; Sodium SERUM, 143 mmol/L; Chloride SERUM, 109 (H) mmol/L; CO2 SERUM, 24 mmol/L; Protein SERUM, 7.4 g/dL; Albumin SERUM 4.6 g/dL; Calcium SERUM, 9.6 mg/dL; Phosphate SERUM, 2.2 (L) mg/dL; Bilirubin SERUM 0l3 mg/dL; Aspartate Aminotransferase SERUM, 21 U/L; Alkaline Phosphatase SERUM, 50 U/L; Cholesterol SERUM, 144 mg/dL; Potassium SERUM, 3.7 mmol/L; GFR Calculated Black SERUM, 128; GFR Calculated SERUM, 106; 11 Sep 2008, MPV BLOOD, 8.1 fL; Neutrophils BLOOD, 54.4%; Lymphocytes BLOOD, 35.3%; Monocytes BLOOD, 7.4%; Eosinophils BLOOD, 1.2%; Basophils BLOOD, 1.2%; Neutrophils BLOOD, 2.6x10(3)/mcL; Lymphocytes BLOOD, 1.7x10(3)/mcL; Monocytes BLOOD, 0.4x10(3)/mcL; Eosinophils BLOOD, 0.1x10(3)/mcL; Basophils BLOOD, 0.1x10(3)/mcL; WBC BLOOD, 4.9x10(3)/mcL; RBC BLOOD, 4.47x10(6)/mcL; Hemoglobin BLOOD, 13.3 g/dL; Hematocrit BLOOD, 39.2%; MCV BLOOD, 87.7 fL; MCH BLOOD, 29.7 pg; MCHC BLOOD, 33.8 g/dL; RDW-CV BLOOD, 11.4 (L)%; Platelets BLOOD, 209x10(3)/mcL; Scheduled for echo on 9/25/08; to be scheduled for stress test with civilian cardiologist	UNK	UNK	BCP	none	none			1						1	Activated partial thromboplastin time shortened; Anxiety; Aspartate aminotransferase normal; Axillary pain; Basophil count normal; Basophil percentage; Blood albumin normal; Blood alkaline phosphatase normal; Blood bilirubin; Blood calcium normal; Blood chloride increased; Blood cholesterol normal; Blood creatine phosphokinase MB; Blood creatine phosphokinase normal; Blood creatinine normal; Blood glucose normal; Blood phosphorus decreased; Blood potassium normal; Blood sodium normal; Blood urea normal; Blood uric acid decreased; Carbon dioxide normal; Chest discomfort; Chest pain; Eosinophil count normal; Eosinophil percentage; Glomerular filtration rate normal; Haematocrit decreased; Haemoglobin decreased; Hypoaesthesia; International normalised ratio; Lymphadenopathy; Lymphocyte count normal; Lymphocyte percentage; Mean cell haemoglobin concentration normal; Mean cell haemoglobin normal; Mean cell volume normal; Mean platelet volume normal; Monocyte count normal; Monocyte percentage; Neck pain; Neutrophil count normal; Neutrophil percentage; Pain in extremity; Palpitations; Platelet count normal; Protein total normal; Prothrombin time normal; Red blood cell count decreased; Red cell distribution width decreased; Troponin I; White blood cell count decreased	FLUN3~MEDIMMUNE VACCINES, INC.~500551P~UNK~OT~~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~UNKNOWN MANUFACTURER~~UNK~ID~LA~SMALLPOX (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0326212	09/25/2008	MA	12.0	12		F	09/25/2008	Pt received Flu Vaccine.  Within 30 minutes she developed hives, prescribed with BENADRYL & Prednisone.				Y					Y	09/24/2008	09/24/2008	0	Allergy Eval - P	PVT	PUB	None	None	nuts	Hives~HPV (Gardasil)~2~12.00~In Patient		1						1	Allergy test positive; Urticaria	FLU3~SANOFI PASTEUR~02802AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0326273	09/26/2008	MD	14.0			F	09/24/2008	Pt received FLUMIST, MENACTRA and GARDASIL, had syncopal event, fell & head injury, and had approx. 15-20 sec generalized seizure.				Y					Y	09/24/2008	09/24/2008	0	Head CT Normal	PVT	PVT		None	None			1						1	Computerised tomogram normal; Convulsion; Fall; Head injury; Syncope	FLUN3~MEDIMMUNE VACCINES, INC.~500544P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0572X~UNK~UN~UN~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2730AA~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0326298	09/26/2008	CA	0.5	0	.5	F	09/18/2008	Fever and seizure on day of injection. Subsequently dx'd with UTI				Y					Y	09/15/2008	09/15/2008	0	Urine Cx (+) for gram negative infection infection	PVT	PVT						1						1	Convulsion; Culture urine positive; Pyrexia; Urinary tract infection	DTAP~SANOFI PASTEUR~C2760AA~3~~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2783EA~1~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF404AA~3~~LL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~A0491~3~~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~D05881~3~~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0470X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0326301	09/26/2008	MD	52.0	52		F	09/22/2008	Extreme itching over arms, face, head, legs, back, broken skin, headaches.									U	09/10/2008	09/10/2008	0	None	OTH	PUB	PAXIL- Blood pressure meds.	None	None			1						1	Headache; Pruritus	FLU3~SANOFI PASTEUR~U2743AA~2~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326303	09/26/2008	FL	4.0	4		F	09/19/2008	Swelling, edema, redness to left deltoid at injection site.  Periorbital edema to left eye.  Improved with BENADRYL.				Y					Y	09/17/2008	09/18/2008	1		PVT	PVT		viral sore throat, neg. strep	none	~Influenza (Seasonal) (no brand name)~1~3.00~In Patient		1						1	Injection site erythema; Injection site oedema; Injection site swelling; Periorbital oedema	FLU3~SANOFI PASTEUR~U2791AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0326307	09/26/2008	VA	6.0	6		M	09/26/2008	Patient received the Live Intranasal Influenza Vaccine on the afternoon of September 23.  That evening patient complained that his right side was bothering him and received the recommended dosage of Advil.  On the morning of Wednesday, September 24, patient woke up still complaining that his side was bothering him.  He had diarriah and started vomiting.  This continued all day and he was taken to Pediatrics Associates at 7:30 PM, lathartic, unable to keep any fluids in and he had vomited approximately 15 times that day and had no urine output until around 7:30.  He was then admitted to the Hospital where he received IV Fluids and blood testing.  He was released the next morning and had recovered with no continued symptoms.  10/7/08 Reviewed hospital labs of 9/24/08.  1/6/09 Reviewed hospital medical records which consisted of birth records & ER records of 12/14/2003 for URI w/cough, runny nose, decreased appetite.  Influenza test (+).  Sibling had influenza at same time.  Tx symptomatically & d/c to home.  Hospital has no further records except labs already received despite multiple searches.  Confirmed w/parent correct hospital.				Y	Y	1			Y	09/23/2008	09/23/2008	0	Blood Test was done at Hospital.  9/24/08 LABS: WBC 13.4(N), neutros 89%(H), lymphs 9%(L).  Creatinine 0.2(L), CO2 21.0(L).	UNK	UNK	Clariton for seasonal allergies.	None	Seasonal alergies, hypospadia, abnormal pallet			1						1	Diarrhoea; Discomfort; Flank pain; Lethargy; Urine output decreased; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500591P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0326311	09/26/2008	SC	52.0	52		M	09/26/2008	Patient was vaccinated on 9/25/08 at approximately 4:00pm with .5ml of Fluzone, lot # U2758AA, exp. 6/30/09.  At approximately 9:00pm while at home the patient experienced tightness, shortness of breath and wheezing which lasted through most of the night but lessened as time passed.  Denied history of Asthma.  Patient reported to Employee Health Service @ 8:30am.  Symptoms already subsided.  Chest ascultated by Dr. Lungs clear bilaterally.									Y	09/25/2008	09/25/2008	0		UNK	UNK	None	None	None			1						1	Chest discomfort; Dyspnoea; Wheezing	FLU3~SANOFI PASTEUR~U2758AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326315	09/26/2008	TX	20.0	20		M	09/26/2008	Diffuse pruritic, erythematous, papular rash involving face/trunk/extremities/palms/soles.  Rash began 25 Sep (9 days after vaccination).  Symptoms preceded 2 days earlier by flu-like symptoms with nasal congestion, cough, headache, myalgias.  Prescribed prednisone, loratadine, hydroxyzine, and ranitidine today.				Y					U	09/16/2008	09/25/2008	9	Mild monocytosis of 11.7%, otherwise normal CBC.	MIL	MIL	None	None	None			1						1	Cough; Full blood count normal; Headache; Influenza like illness; Monocyte percentage increased; Myalgia; Nasal congestion; Rash erythematous; Rash papular; Rash pruritic	FLUN3~MEDIMMUNE VACCINES, INC.~500547P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~UNKNOWN MANUFACTURER~unknown~1~ID~LA~SMALLPOX (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0326316	09/26/2008	NY	49.0	49		F	09/26/2008	Patient developed an erythematous, pruritic cutaneous rash on her arms and legs twenty four hours after vaccine administration.  Patient was treated with benadryl.									Y	09/22/2008	09/23/2008	1	none	PUB	PVT	none	none	none			1						1	Rash erythematous; Rash pruritic	FLU3~SANOFI PASTEUR~U2805AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326321	09/26/2008	WI	7.0	7		F	09/26/2008	The day after Fluzone was administered, the arm that the vaccine was placed in became swollen, itchy, red, and hot to touch.									Y	09/18/2008	09/19/2008	1		PVT	UNK		Child was healthy.				1						1	Erythema; Oedema peripheral; Pruritus; Skin warm	FLU3~SANOFI PASTEUR~U2786CA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326323	09/26/2008	AK	45.0	45		F	09/26/2008	When I woke up from a nap,4 hours after I got the flu shot I felt very nauseated like every place on my body hurt stomach, joints, head, muscles etc. I developed diarrhea,congestion,severe headache and nausea over the next two days.  I am still feeling achy and a little on the nauseated side but the diarrhea has subsided.  Treatment was rest and liquids.									Y	09/23/2008	09/23/2008	0	none done	PUB	UNK		no illness at time of vaccination	I am a diabetic			1						1	Diarrhoea; Headache; Nausea; Pain; Respiratory tract congestion	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA172AA 09JN~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0326326	09/26/2008	MI	14.0	14		M	09/26/2008	pt was given immunizations at aprox. 11:30am showed up to emergency room at aprox noon with anaphylaxis treatment administered by emergency department.				Y					Y	09/26/2008	09/26/2008	0		UNK	UNK		None	Asthma, developmental delay, autism			1						1	Anaphylactic reaction	FLU3~SANOFI PASTEUR~u2756aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~u2689aa~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~c2865aa~6~IM~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~0993x~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0326327	09/26/2008	MT	1.0	0	1	F	09/26/2008	Recieved shots 7/17/2007. After midnight 7/18/07, father was watching TB, heard baby gurgling.  Mother woke up from sleeping and found baby blue and limp.  They ran out of the house and by the time she arrived at the ER, baby was crying.  Discharge diagnoses on 10/19/07 were: 1.  Right otitis media  2.  Slow weight gain, but within normal grawth cart  3.  History of preumonia  4.  Possible reflux. Dischareged with apnea monitor. 12/23/2008 MR received for DOS 10/18-19/2008 with D/C DX:  R Otitis Media.  Slow weight gain, but within normal growth chart.  Hx of pneumonia.  Possible reflux.  Pt presented to ER after episode of gurgling, limpness and cyanosis. Crying upon arrival.  TM red and bulging. Tx-abx. Placed on apnea monitor with no further events. ? reflux. D/C on home monitor.				Y	Y	1			Y	10/17/2007	10/18/2007	1	Labs and Diagnostics:  CBC with WBCs 15.3-42% lymphs. CXR WNL.	UNK	UNK	unknown	none	History of pneumonia. PMH:  pneumonia.  slow weight gain. chronic cough x 6 months..			1						1	Crying; Cyanosis; Hypotonia; Otitis media	DTAP~SANOFI PASTEUR~C2650AA~UNK~IM~~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2459NA~UNK~PO~MO~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~Z0547~UNK~IM~~POLIO VIRUS, INACT. (IPOL)~1	USA	Hospitalisation	Influenza
0326328	09/26/2008	CA	49.0	49		F	09/26/2008	Approximately 12 hours after recieving the vaccine I broke out in hives. Benadryl 25mg. Taken at that time and every 4-6 hours after.Hives lasted for 2 days.									Y	09/22/2008	09/23/2008	1		UNK	UNK	synthroid	none	Latex			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2785GA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326331	09/26/2008	NC	67.0	64		M	09/26/2008	Flu Vaccine-Flulaval given at 1:45 today, once patient returned home after shot developed aches but began to have a fever which is currently 7pm 101.6									U	09/26/2006	09/26/2008	731		PVT	UNK		no	unknown			1						1	Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflla175aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0326341	09/26/2008	WA	47.0	47		F	09/26/2008	Administered dose FLUARIX. Patient called with question of ABR. Pt sent to hospital. Hospital called pharmacy with Dx: Anaphylaxis. Pt tx for condition with SC therapy and BENADRYL, EPINEPHRINE, Dextrosol. Shot given 14:05. Pt called approximately 1600.   11/03/2008 ER record received for 9/25/2008 with DX: Allergic Reaction-acute to Influenza vaccine. Pt presented with SOB, wheezing and feeling throat closing.  PE (+) for anxiety, angioedema of the uvula and pharynx, hoarse voice and moderate respiratory distress. Tx: Benadryl, epi, albuterol nebs, decadron and depomedrol.			Y	Y					Y	09/25/2008	09/25/2008	0		OTH	PUB		None	PMH:  Pancreatic CA			1						1	Anaphylactic reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA566CA~2~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Life Threatening	Influenza
0326344	09/26/2008	MT	74.0	74		F	09/26/2008	Received shot on 9/23/08 pt called 9/26/08 reported swelling, itching & blister at site of injection.  Pt did stop by and a blister with swelling & redness was confirmed.  Pt has no fever or systemic symptoms.  Slightly worried about blister due to the live vaccine.									U	09/23/2008	09/26/2008	3		OTH	PVT	Amloasorne, simvastatin, atenolol, PLAVIX, levothyroxone	None				1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Injection site vesicles	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARZOS~MERCK & CO. INC.~0557X~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0326345	09/26/2008	AZ	15.0	15		F	09/26/2008	Hives, fever, vomiting.									Y	09/26/2008	09/26/2008	0	None	PVT	PVT	None	None	None			1						1	Pyrexia; Urticaria; Vomiting	FLU3~SANOFI PASTEUR~U2751AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326346	09/26/2008	NY	11.0	11		M	09/26/2008	Child c/o chest pain & tightness in throat 5 min after vaccines given.  No hives, no SOB, VS stable - sent to ED for care.				Y					Y	09/26/2008	09/26/2008	0		PVT	PVT		None	allergy to bee stings			1						1	Chest pain; Throat tightness	FLU3~SANOFI PASTEUR~UT2782FA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2731AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2865AA~UNK~IM~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~U989X~UNK~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0326347	09/26/2008	OH	12.0	12		M	09/26/2008	I wanted to report to you an adverse drug reaction for patient 8-29-96.  He received 4 vaccinations on 9-23-08 in the evening around 6:30 pm, by 9:00 pm he was complaining of headache, body ache, stomach ache.  I gave him some MOTRIN and sent him to bed.  In the morning he still did not feel better and stayed home from school.  Last night he said he had insomnia.  He did have a low grade fever 100.8 while on the MOTRIN.  Naturally his arms are sore and he has reported to me twice that his hand on the left side went numb.  Of course my mind goes straight to Guillain-Barre Syndrome.  I had him stretch his arms and he said it went away, so I don't know if that is related.  He still feels lousy today so he is staying home again.  The injection site on his left arm (I think) does have some redness and swelling around it.  Let me know what I should watch for.  Thanks.									Y	09/23/2008	09/23/2008	0		PVT	PVT	None	None				1						1	Abdominal pain upper; Headache; Hypoaesthesia; Injection site erythema; Injection site swelling; Insomnia; Malaise; Pain; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U2762AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2731AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2865AA~1~IM~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1002X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0326332	09/27/2008	TX	1.5	1	.5	F	09/27/2008	Mother reports that she woke up in the middle of the night crying and having repeated tensing/shaking episodes.  So mother brought daughter to the ER to be checked.  I evaluated her and found no abnormalities.				Y					Y	09/26/2008	09/27/2008	1		UNK	UNK	Motrin given earlier that evening	teething as well as Upper Respiratory symptoms				1						1	Crying; Nervousness	FLUX~UNKNOWN MANUFACTURER~~2~~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~2~~LL~HEP A (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0326334	09/27/2008	TX	31.0	31		F	09/27/2008	Pt received injection.  Shortly thereafter pt started feeling numbness in lip and left arm and light headeded.  Pt then started getting redness on neck and side of body where she received vaccine.  Rph took pt's blood pressure and pulse and both were high.  EMS was called and pt was observed.  Rph was going to give pt epinephrine and EMS arrived.  EMS gave pt diphenhydramine and took pt to hospital.				Y						09/27/2008	09/27/2008	0		UNK	PVT			pt has a prior history of SVT's			1						1	Dizziness; Erythema; Heart rate increased; Hypertension; Hypoaesthesia; Hypoaesthesia oral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88636~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0326336	09/28/2008	MI	27.0	27		M	09/28/2008	about 6 hours later, I develop pruritis over my entire body.  When scratched it developed in wheals. Its been ongoing for 3 days.				Y					U	09/25/2008	09/25/2008	0		PUB	UNK	none	none	none			1						1	Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0326402	09/29/2008	KY	51.0	51		F	09/22/2008	Rash under arms, breasts and waist areas.									Y	09/15/2008	09/15/2008	0		PUB	UNK	Mycardis 8/20; Melatonin; Vytorin; ASA; Advil					1						1	Rash	FLU3~SANOFI PASTEUR~U2739AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326407	09/29/2008	PA	64.0	64		F	09/25/2008	Cellulitis right arm									U	09/22/2008	09/24/2008	2		PUB	PVT			None			1						1	Cellulitis	FLU3~SANOFI PASTEUR~U2760AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326416	09/29/2008	TX	1.1	1	.1	M	09/10/2008	Varicella vaccine was given in left anterior thigh. Immediately following the vaccine the patients leg appeared very red with welts measuring about 2 inches. no systemic signs. Observed patient for 30 mins in office and applied cold compress for 8 minutes.									Y	09/08/2008	09/08/2008	0	None	UNK	UNK	None	None	None			1						1	Immediate post-injection reaction; Injection site erythema; Injection site reaction; Injection site urticaria	FLU3~SANOFI PASTEUR~U2757AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~B245AA~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0931X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C45724~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0999X~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0326420	09/29/2008	OH	40.0	40		F	09/27/2008	redness, itching, hot, hard welt appeared at injection site									Y	09/26/2008	09/26/2008	0		OTH	OTH	SINGULAIR; FLOVENT; ZOLOFT; PROAIR; ALLEGRA-D 24 hr		asthma, hypertension, allergies, depression			1						1	Injection site erythema; Injection site induration; Injection site pruritus; Injection site urticaria; Injection site warmth	FLU3~CSL LIMITED~02049111a~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0326426	09/29/2008	KS	35.0	35		F	09/29/2008	At 7:00 PM I received the flu shot. At 12:15 AM I start coughing because I felt like something was suddenly in my throat. My throat quickly warmed and the warming sensation traveled along my throat down into my chest. I then start having chills and shaking. Vomiting and dry heaving followed with extreme muscle ache. The muscle was so intense that it hurt to lay down and I could not get comfortable. These symptoms lasted until about 4:00 Am. I had muscle soreness and a tender arm where I received the injection for 2 days following.									Y	09/22/2008	09/23/2008	1		PVT	PVT	none	none	none			1						1	Chills; Cough; Feeling hot; Injection site pain; Myalgia; Retching; Sensation of foreign body; Tremor; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0326428	09/29/2008	MA	14.0	14		M	09/29/2008	Pt received flu vaccine in left deltoid and then Menactra in right deltoid;immediately after Menactra given as bandaid about to be applied,pt became very pale and faint.Pt was assisted to a supine position and then noted to be very red in the face,eyes staring,unresponsive,arms and legs tonic for approx 10 seconds.Immediately afterwards pt talking and responsive.examined by Dr. Pt given juice and crackers and remained supine for approx 20mins then allowed to sit but pallor returned slightly so he reclined again.After further 20 mins pt gradually acheived a sitting position.Eventually able to leave office in a wheelchair expressing acute hunger for lunch.									Y	09/26/2008	09/26/2008	0	None	UNK	UNK	Duac topical gel	none	acne,scoliosis			1						1	Dizziness; Erythema; Hypertonia; Immediate post-injection reaction; Pallor; Staring; Unresponsive to stimuli	FLU3~SANOFI PASTEUR~u2748aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~u2732aa~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0326431	09/29/2008	CA	71.0	71		F	09/29/2008	left arm swollen, pain down arm, not relieved by anti-inflamatory, some nausea....limited range of motion									U	09/28/2008	09/29/2008	1		PVT	UNK	None	none	none			1						1	Injected limb mobility decreased; Nausea; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~unknown~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326438	09/29/2008	CO	28.0			F	09/29/2008	Patient just found out that she is pregnant and they suspect she is 7 weeks pregnant - she would have been 5 weeks pregnant at the time										09/12/2008			2 Sept 2008 - HCG negative in CHCSII - no other data in CHCSII  - she reports a sonogram was performed and home pregnancy tests were positive	UNK	UNK		At the time, she felt like she had a URI.  No nausea at that time.				1						1	Drug exposure during pregnancy; Pregnancy test positive; Ultrasound scan	FLUN3~MEDIMMUNE VACCINES, INC.~500552p~4~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0326443	09/29/2008	TX	66.0	66		F	09/29/2008	Symptoms began 5 hours after injection. It started with chills & body ached all over. I went to bed at 9pm with a fever of 101.6. During the next 4-5 hours it continued to rise as high as 104.6. I took Tylenol for the pain & fever. I took a tepid shower around 12 midnight which brought the fever down a bit. At this time Monday 8/29/08,6:30 pm CDT,  my fever & aches continue.									U	09/28/2008	09/28/2008	0	none	UNK	UNK	Ziac,Levoxyl,Salagen,Tricor,DetrolLA,Diovan,Norvasc,Seroquel,Nexium,Cymbalta,Natatb,Vit D,ASA 81, Melatonin,Hyoscamine ODT,	none	NASH	None~ ()~NULL~~In Patient		1						1	Chills; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~unknown~7+~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0326444	09/29/2008	AZ	54.0	54		F	09/29/2008	patient received pneumovax in right arm on 9/262008. returns on 9/29/2008 with 6cmby 12cm erythematous patch on right arm that has continued to spread in size over lastthree days.  area is hot to touch and extremely tender to touch. no nodes are palpable in right axilla and there is no red streaking. Patient advised to go to urgent care for antibiotic therapy TONIGHT as her doctor's office is closed. suggensted that she may need IM injection of antibiotics to begin treatment  notes she had s similar reaction to a tetanus shot sometimein the past									U	09/26/2008	09/26/2008	0		UNK	UNK	unknown	none claimed	unknown	similar redness andswelling~ ()~~0.00~In Patient		1						1	Erythema; Skin warm; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0964U~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0326450	09/29/2008	CA	5.0	5		M	09/29/2008	Left arm redness and swelling, no fever, taking TYLENOL for pain. Also BENADRYL for itching. To be seen if worsens.									U	09/24/2008	09/26/2008	2	None	PVT	PVT	SINGULAIR; ALBUTEROL; ADVAIR DISKUS	None	Asthma			1						1	Injection site erythema; Injection site swelling; Pain; Pruritus	DTAP~SANOFI PASTEUR~C2957AA~5~IM~UN~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2786BA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326454	09/29/2008	GA	61.0	61		F	09/29/2008	Client called office states she has flu like symptoms, fever, N/V and pain. She feels she may have had reaction to pneumonia shot.									N	09/25/2008	09/26/2008	1	None	PVT	UNK			codeine			1						1	Influenza like illness; Nausea; Pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2804AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0090U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0326455	09/29/2008	IL	13.0	13		F	09/29/2008	Was given 2 injections, within seconds passed out for a brief moment.									Y	09/29/2008	09/29/2008	0		PVT	UNK			No			1						1	Immediate post-injection reaction; Loss of consciousness	FLU3~SANOFI PASTEUR~U2788EA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0843X~UNK~UN~LA~HPV (GARDASIL)~1	USA		Influenza
0326457	09/29/2008	AZ	52.0	52		F	09/29/2008	Fever, arm swollen, red, hot.  Seen this am - given AB's x 5 days										09/25/2008	09/26/2008	1	None	PVT	PVT		None	Seasonal allergies			1						1	Erythema; Oedema peripheral; Pyrexia; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~A359CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1384U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0297382	09/30/2008	OH	82.0	82		M	09/20/2008	Three days after vaccine had numbness at site of flu shot which spread to both arms and legs. Four days later had multiple organ failure and paralysis. To date has been in 4 hospitals and has only made a partial recovery.  1/29/2010 Follow-up: As of 12-1-09 patient has very limited mobility of the nectk, arms, and hands. Patient is still unable to walk.			Y	Y	Y	11	Y	Y	N	10/19/2007	10/22/2007	3	Initial test for stroke etc. were all normal. Later diagnosed with Transverse Myelitis.	PVT	OTH	Metformin; Simvastatin; Allopurinol; Lisinopril	None	High blood sugar and cholesterol and blood pressure - previous kidney stone			1						2	Abasia; Hypoaesthesia; Injection site anaesthesia; Laboratory test normal; Mobility decreased; Multi-organ failure; Paralysis	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0326179	09/30/2008	WI	5.0	5		M	09/26/2008	Initial report received from a health care professional on 25 September 2008. A 5-year-old male patient had received a left arm intramuscular injection of DAPTACEL (lot number C2956AA), a right arm intramuscular injection of IPOL (lot number A0836), a right arm subcutaneous injection of MMR II (manufacturer Merck, lot number 1119X), a left arm subcutaneous injection of VARIVAX (manufacturer Merck, lot number 1002X) and a intranasal dose of FLUMIST (manufacturer MedImmune Vaccines, lot number 500545P) on 24 September 2008. Thirty minutes after the vaccinations, the patient became flushed with hives present; his eyelids, tongue and lips were swollen; he was having difficulty swallowing; had decreased responsiveness (eyes were open, but he was not talking), and the patient's mother returned him to the doctor's office. An emergency phone call was made for paramedics. On exam, the patient's physician found him to be tachycardic with normal respiratory rate. Epi-pen Jr was administered to the left thigh. Oxygen saturation was 96-98%. Paramedics arrived within five minutes and the patient was transported to the hospital in stable condition for further evaluation and treatment. Details concerning evaluation and treatment were not provided. It was reported that the patient recovered.				Y					Y	09/24/2008	09/24/2008	0	Oxygen saturation 96-98%	PVT	PVT			Not reported		200802984	1						3	Depressed level of consciousness; Dysphagia; Eyelid oedema; Flushing; Lip swelling; Oxygen saturation normal; Respiratory rate; Swollen tongue; Tachycardia; Urticaria; Drug hypersensitivity; Dysphagia; Eyelid oedema; Flushing; Hypokinesia; Lip swelling; Swollen tongue; Tachycardia; Urticaria; Depressed level of consciousness; Dysphagia; Eyelid oedema; Flushing; Lip swelling; Oxygen saturation normal; Respiratory rate; Swollen tongue; Tachycardia; Urticaria	DTAP~SANOFI PASTEUR~C2956AA~5~IM~LA~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500545P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~A0836~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1119X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1002X~2~SC~LA~VARICELLA (VARIVAX)~1|DTAP~SANOFI PASTEUR~C2956AA~5~IM~LA~DTAP (DAPTACEL)~2|FLUN3~MEDIMMUNE VACCINES, INC.~50054P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|IPV~SANOFI PASTEUR~A0836~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~2|MMR~MERCK & CO. INC.~1119X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~2|VARCEL~MERCK & CO. INC.~1002X~2~SC~LA~VARICELLA (VARIVAX)~2|DTAP~SANOFI PASTEUR~C2956AA~5~IM~LA~DTAP (DAPTACEL)~3|FLUN3~MEDIMMUNE VACCINES, INC.~500545P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3|IPV~SANOFI PASTEUR~A0836~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~3|MMR~MERCK & CO. INC.~1119X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~3|VARCEL~MERCK & CO. INC.~1002X~2~SC~LA~VARICELLA (VARIVAX)~3	USA	Emergency room visit	Influenza
0326537	09/30/2008	IL	88.0			U		Fatigue, sore throat, leg rash.									U					OTH	UNK		None	HTN			1						1	Fatigue; Pharyngolaryngeal pain; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA1938A~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0326565	09/30/2008	OK	0.5	0	.5	F	09/30/2008	Localized allergic reaction (L) thigh red and swelling.									Y	09/23/2008	09/25/2008	2	None	PVT	PVT	None	None	None			1						1	Hypersensitivity; Injection site erythema; Injection site swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B087AA~3~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2772AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0836~3~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~C69205A~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0641X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0326566	09/30/2008	CA	75.0	75		F	09/30/2008	Limb swelling involving entire right arm, within 24 hours of vaccination. Erythema from elbow to shoulder and down right flank. Rheumatologist prescribed Keflex treatment for 7 days on 09/25/2008. Improving by 09/29/2008				Y					Y	09/24/2008	09/25/2008	1	None	PUB	PUB	EFFEXOR, LIPITOR, Lorazepam, PREMARIN, ZESTRIL,Cortisone every 4 months.	Lupus erythematosus	Coccidioiclomycosis -Dx 1980 in Kern County			1						1	Erythema; Oedema peripheral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFUA178AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0993U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0326574	09/30/2008	GA	52.0	52		F	09/30/2008	I received the shots at a local drug store .  I got it on Thursday afternoon and Friday evening I started running a fever.Both shots were given in my right arm. I ask if it was okay before they did it and if there was a problem getting both at one time and in the same arm. I was told no.  After the fever started on Friday evening I had chills and aches.  I live by myself so I stayed in bed all day Saturday and Sunday and went to the doctor on Monday. I could not raise my right arm and it was very warm and red in a spot about the size of a baseball. My fever on Friday evening, all day Saturday, and Sunday ran about 101 to 104.  I could not hardly get out of bed.  I woke up both Friday night and Saturday night drenched and had to had to change clothes. Monday my fever stayed at about 100 all day. Today Tuesday)it is around 99 or a little above. I have missed work for two days because I am so weak and feel so bad. I am going to try to go back tomorrow. The doctor I saw on Monday prescribed Dexamethasone 1.5 mg for 7 days and Amox TR-K CLV 875-125 MG Tasan for 10 days. I am to follow up at the doctor tomorrow. I have had the flu shots yearly for probably 15 years and the pheumo every five years and never had a problem.I have a message at your office for someone to call me. I have questions and would appreciate talking with someone.									U	09/25/2008	09/26/2008	1	No test were done when I went to the doctor on Monday.  The doctor just gave me medication and I follow up tomrorrow 10-1.	UNK	PVT	I take - Miloxicam 7.5 mg(1 per day) Warfarin 5 mg(1) Hyclorxchlor 200 mg (1) Benazep/hctz 20/25 mg(2) simvastatin 40 mg(1) Atenolol 50 mg(1)	None	Heart - Mechanical valve, high blood pressure, connective tissue disease, high chlor.			1						1	Asthenia; Chills; Erythema; Hyperhidrosis; Impaired work ability; Injected limb mobility decreased; Malaise; Pain; Pyrexia; Skin warm	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0326578	09/30/2008	CA	46.0	47		F	09/30/2008	Pt developped extreme pain, soreness and swelling size of tennis ball. Pt will go to urgent care center immediately to be assessed by physician.									U	09/29/2008	09/29/2008	0		PUB	UNK						1						1	Pain; Swelling	FLU3~SANOFI PASTEUR~U2750aa~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0038U~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0326579	09/30/2008	TX	43.0	43		F	09/30/2008	9/25/08 Hours after reciving vaccine, I began to experience pain under my left armpit (lymph nodes enlarched) and some swelling on the same side/arm I received the vaccine.  9/30/08 I still have the swelling and pain is increasing.  No other adverse reaction noticed, site of injection without redness or swelling at the time of filling out report.									Y	09/25/2008	09/25/2008	0	none	PUB	UNK	NONE	NONE	NONE			1						1	Axillary pain; Lymphadenopathy; Oedema peripheral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUEA350BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0326590	09/30/2008	OH	2.0	2	.0	F	09/30/2008	2 yr old with sudden onset of flaccid quadriplegia on 9/27/08. Pt awakened from a nap unable to move arm or legs. Pt had spontaneous respirations and was able to move head. Pt had received FLUMIST on 9/22/08 during her 2-yr well exam. Mom reported by Friday 9/27/08 she had a fever of 101. Around 12:30 pm pt was put to bed for a nap. The pt awoke at 2 pm screaming and unable to move. Neuro exam on 9/29 - abdominal and deep tendon reflexes are absent. Decreased chest wall movement, labored breathing noted - pt intubated. MRI - swelling of C-spine C2-C7.   1/22/09 MR received for DOS 9/28-~11/3/2008 with D/C DX: Longitudinally extensive Transverse Myelitis.  Flaccid Quadriplegia.  Respiratory Failure. S/P Tracheostomy.  Constipation.  UTI (enterococcus), resolved. Pt presented after abrupt onset of inability to move arms and legs. Pt had had 1 wk hx of rhinorrhea and cough & received Flumist 6 days prior to admission. Pt noted to have no movement in arms and legs in ED. Absent reflexes. 1 episode of emesis. T=101'F.  Initially able to breathe on own however developed respiratory difficulty requiring intubation and later a trach. Some fluctuations of HR due to autonomic instability. Tx with solumedrol and plasmapheresis with some improvement in lower extremities only. Developed anemia during plasmapheresis. D/C to rehab. Follow-up Information 05-NOV-2008: 2yo female present with sudden onset flaccid quadriplegia. No trauma - taken to hospital where head and spine CT nl. Approx 1 week hx of rhinorrhea and cough. Received FluMist vaccine 6 days PTA.			Y		Y	34	Y	Y	N	09/22/2008	09/27/2008	5	[[address]]head and spine (-).PMH: febrile seizure 12/2007.  Somatosensory evoked potentials unobtainable. Visual evoked potential WNL. Brain MRI WNL. MRI of spine (+) for abnormal signal in cervical and thoracic cord as well as swelling noted of cervical spinal cord. CSF with 4 WBC and (+) RBCs protein 34.6, glucose 66. No oligoclonal bands. Myelin Basic Protein WNL  2.5. IgG slightly increased at 0.7. Repeat with CSF glucose 108, Myelin Basic Protein 10.9 (H). CSF cx (-). Blood and urine cx (-) initially. UC later (+) for enterococcus. Viral tests all (-). Hgb 9.6. Hct 29.3. Follow-up 05-NOV-2008: Neuro imaging MRI, CT, ANAQ, CSF	PVT	PVT	None	Rhinorrhea and cough	Febrile seizures Aug 07 and Dec 07. PMH: febrile seizure			1						1	Areflexia; Dyspnoea; Endotracheal intubation; Hypokinesia; Neurological examination abnormal; Nuclear magnetic resonance imaging abnormal; Paralysis flaccid; Pyrexia; Quadriplegia; Screaming; Swelling	FLUN3~MEDIMMUNE VACCINES, INC.~5005448~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0326591	09/30/2008	CO	67.0	67		F	09/30/2008	Sharp pains in area of shot when I move my arm. Arm unusually very sore.									Y	09/17/2008	09/17/2008	0	no fever	OTH	OTH		none	none			1						1	Body temperature; Injection site pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2742AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326592	09/30/2008	WA	84.0	84		F	09/30/2008	On 9/29/08 patient reported severe bruise on entire upper right arm. Bruise is worse around injection site. She said it was painful when she touched the bruise area. Bruise appeared on 9/27/08 following vaccination. Patient is on coumadin and ASA.										09/27/2008	09/27/2008	0	She has her coumadin level checked monthly.	OTH	PVT	Coumadin	None				1						1	Blood test; Contusion; Injection site bruising; Injection site pain; Pain	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326594	09/30/2008	AZ	70.0	70		F	09/27/2008	The patient experienced severe pain, edema and erythema to region of left deltoid extending the entire circumference of her arm down to her distal humerous.									U	09/24/2008	09/25/2008	1		PVT	UNK		Benign Hypertension	Asthma, DJD, Nicotine Addiction, GERD			1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88806~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~13840~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0326597	09/30/2008	WA				M		Approx 2 hrs after vaccine injection his speech was slurred and had a seizure. He was then taken to hospital.				Y					U					OTH	OTH						1						1	Convulsion; Dysarthria	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0326598	09/30/2008	CA	51.0	51		F	09/30/2008	Patient claims that 48 hrs after flu shot she began to experience vertigo-like symptoms. Dizziness, light-headedness, ringing in ears, loss of balance. No treatment mentioned in phone conversation. Said symptoms are worsening.									N	09/23/2008	09/25/2008	2	None	OTH	PVT	Unknown	None	None			1						1	Balance disorder; Dizziness; Tinnitus; Vertigo	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89620~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0326602	09/30/2008	IL	1.5	1	.5	M	09/26/2008	Within 48 hours of injection of DTaP red swelling, heat, tenderness developed.									Y	09/23/2008	09/25/2008	2	None	PVT	PVT	None	None	None			1						1	Skin warm; Swelling; Tenderness	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B085AA~UNK~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~42741AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB297CA~1~IM~LL~HEP A (HAVRIX)~1	USA		Influenza
0326632	10/01/2008	MO				F	09/29/2008	Initial information was received from another manufacturer health care professional on 23 September 2008.  The initial reporter to this manufacturer had been a health care professional.  A female patient with no reported past medical history developed an anaphylactic reaction after receiving an influenza vaccine sometime in the past (lot number, manufacturer, date, route and site of vaccination was not reported).  No further information was provided.				Y									None reported	UNK	UNK			The patient's past medical history was not provided.		200802966	1						1	Anaphylactic reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0326642	10/01/2008	NC	74.0	74		F	09/30/2008	Redness and warmth of right upper arm.				Y						09/29/2008	09/29/2008	0	No	PVT	PVT			Allergic to PCN, Sulfa, Zoloft, Muocydine.  Conditions - HTN, hyperlipidemia, restless leg syndrome			1						1	Erythema; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88910~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1384U~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0326677	10/01/2008	MA	49.0	49		F	10/01/2008	Employee received flu vaccine approx 11:30 am on 9/23/08.  Went to lunch outside, ate sardines.  After returning to work felt warm and flushed. Before leaving for home at 3:30-3:45, came to Employee Health.  Face was flushed and swollen,hives on neck, no respiratory distress.  She was taken down the hall to ACU(ambulatory Care)and treated.  Seen by MD.  Treated with solumedrol and benadryl, observed and sent home on prednisone and benadryl. Spoke with her 9/30 and she reported facial symptoms improved by 9/24 but hospitalized on 9/26 and admitted until 9/28 for respiratory distress.  10/02/2008 Ambulatory Services MR received for 9/23/08 with DX:  Anaphylactoid reaction with unknown allergen. Pt presented 4 hours s/p Flu shot with c/o red face, watery eyes, dry tickle type cough and some difficulty breathing. PE (+) for erythema of face and neck and mild conjunctival edema and erythema.  TX with Solumedrol IV, Benadryl and O2. D/C with Epipen and Medrol dosepak./pc 10/10/2008 MR received for DOS 9/26-28/2008 with D/C DX:  Acute Allergic Reaction.  Asthmatic Bronchitis. Reactive hyperglycemia.  Insomnia.  Allergic Diathesis. Pt presented several day after above incident with increased wheezing, tachypnea, and non-productive cough with chest discomfort after. Admitted due to RR 28 and wheezing despite nebs and steroid tx. Feeling of chest constriction continued despite tx. D/C on steroids, Combivent, Benadryl and with Epi-pen PRN.				Y	Y	3			N	09/23/2008	09/23/2008	0	Labs and Diagnostics: CXR WNL. Chem with K+ 3.0, Co2 23, blood glucose 128. UA with 2+ glucose (thought to be 2' to steroids). Sinus X-ray WNL. CK WNL. Troponin T <0.01.	UNK	UNK			PMH: sinusitis, env allergies, SOB, h/a, neck pain, ? radiculopathy, ? hypoglycemia			1						1	Feeling hot; Flushing; Respiratory distress; Swelling face; Urticaria	FLU3~SANOFI PASTEUR~u2741aa~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0326693	10/01/2008	OH	40.0	40		F	10/01/2008	Pt developed hives and itching to her torso, arms and legs				Y					Y	10/01/2008	10/01/2008	0		PUB	UNK	diavan hct, protonix	possibleendocrine tumor	PCN, Bactrim			1						1	Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA380CA63009~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0326695	10/01/2008	AZ	56.0	56		M	10/01/2008	Migraine Headache within 12 hours of administration of vaccine.									Y	10/01/2008	10/01/2008	0		PUB	PUB						1						1	Migraine	FLUX~UNKNOWN MANUFACTURER~89681~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0326705	10/01/2008	CA	52.0	52		U		Approximately 6 hours after immunization, got fever, headache, myalgias, laminating pain, red, hot, swollen injection site of Pneumo.									N	09/29/2008	09/29/2008	0		PUB	PUB			Depression, hard of hearing.			1						1	Headache; Injection site erythema; Injection site swelling; Injection site warmth; Myalgia; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0619X~1~SC~LA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U1993CA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0326707	10/01/2008	FL	72.0	72		M	10/01/2008	Hives at the site of injection-small covering a quarter size area around injection site. Pt took BENADRYL-2 hrs later- Rash is not bigger-also seen by PMD by then.									Y	10/01/2008	10/01/2008	0	None	OTH	PVT		itch-small hives	HTN; DM			1						1	Injection site urticaria	FLU3~SANOFI PASTEUR~U2831AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1382U~2~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0326708	10/01/2008	NE	3.0	3		F	10/01/2008	Local reaction 3 x 3 cm red, rash, not warm, not indurated, not painful.  Treated with Benadryl.									Y	09/29/2008	09/30/2008	1		PVT	UNK						1						1	Injection site erythema; Injection site rash; Injection site warmth; Local reaction	FLU3~SANOFI PASTEUR~U2756AA~5~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326710	10/01/2008	MA	73.0	73		F	10/01/2008	Patient was receiving FLUVIRIN 0.5ml, IM injection.  Patient pulled away and only got partial injection.  The rest dripped down her arm.									Y	10/01/2008	10/01/2008	0		OTH	PUB		None	None			1						1	Underdose	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0326711	10/01/2008	WV	62.0	62		M	10/01/2008	On 9-18-08 had flu vac around 3pm. Between 5 and 7 pm he became very achy, especially in lges-no temp noted-gradually at better our 2-3 days									Y	09/18/2008	09/18/2008	0		PVT	PVT	LIPITOR; GLUCOPHAGE; LOTENSIN; ACTOS	9/10/08 c/o headache and fatigue	None			1						1	Pain	FLU3~SANOFI PASTEUR~U2784GA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326714	10/01/2008	TX	52.0	52		F	10/01/2008	(L) deltoid area red swollen area 110 mm x 70 mm with induration									Y	09/30/2008	09/30/2008	0	None	PVT	UNK		itching-red-swollen	Allergic- BENADRYL and ASA			1						1	Erythema; Induration; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8803905~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0326716	10/01/2008	OH	63.0	63		F	09/28/2008	Pt had MENACTRA and PNEUMOVAX administered here 9/10/08 (Flu shot given by another Dr). Had splenectomy 9/26/08. While in hospital patient experienced arm paralysis. Also received Hep B at health clinic. 12/1/08-records received for DOS 9/24-9/30/08-DC DX: Thrombocytopenia. Splenomegaly. Myelofibrosis. Admitted due to enlarged spleen, thrombocytopenia caused by myelofibrosis syndrome diagnosed July 2008. Splenectomy. Received influenzae vaccination pre operatively, pneumonia vaccination and meningitis vaccination. Ventilator for atelectasis. Developed right sided weakness in arm after surgery weakness. Similar weakness as part of multiple sclerosis diagnosed 10 years ago. Impression: could have an exacerbation of previously weak point that can happen after stressful circumstances such as surgery or new multiple sclerosis plaque					Y	6			Y	09/11/2008	09/26/2008	15	12/1/08-records received- WBC 56.40.	OTH	OTH			NKA on file here 12/1/08-records received-PMH :Multiple sclerosis diagnosed 1993. Hypertension. Gastroesophageal reflux. Myelofibrosis syndrome. Cellulitis of left arm. Anxiety. Depression.			1						1	Splenectomy	FLUX~UNKNOWN MANUFACTURER~88637~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MNQ~SANOFI PASTEUR~U2635AA~UNK~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PPV~MERCK & CO. INC.~00384~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0326718	10/01/2008	TX	32.0	32		F	09/30/2008	Patient experienced parasthesia to hands, face, and lower extremities (Left leg and foot). MD evaluation suggested that employee had a reaction to flu shot. Prescribed steroid (liquid) 2 tablespoons x 2 days				Y					Y	09/25/2008	09/25/2008	0		PVT	PVT	None	none	none			1						1	Immunisation reaction; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA173AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0326719	10/01/2008	TX	37.0	37		F	10/01/2008	fever, headache, swelling left arm, axillary, cervical, clavicular lymphadenopathy 8 days post receipt primary SPV and FLUMIST. Tmax 104.0 on 9/22/2008; headache severity progressed to 9/10 9/23/2008; 3 satellite lesions around SPV site, date first noted unknown; 2 possible autoinoc lesions: noticed over right thumb pad 9/20/2008; noticed between right 4th/5th toe 9/23/2008; small round macule noted on upper lip 9/24/2008; seen in ER 9/22; followed up at another hospital 9/23. 9/26/2008 bilateral wrist and finger swelling/pain; single erythematous macule over left 1st and right 5th MCP joint. As of 10/1/2008 symptoms resolved. Symptoms: Joint pain, Isolated, swelling, lesions, macule, lesions, macule, lesions, pustule, fever, headache, general, lesions, pustule, lesions, pustule.				Y					Y	09/12/2008	09/20/2008	8	Labs - 9/22/2008 - CBCdiff unremarkable; CMP with slight elevation AST/ALT - (46/69); skin wound culture - )SPV site) - mixed normal skin flora	MIL	MIL	None	None	None			1						1	Alanine aminotransferase increased; Aspartate aminotransferase increased; Culture wound; Erythema; Full blood count normal; Headache; Lymphadenopathy; Metabolic function test; Oedema peripheral; Pain in extremity; Pyrexia; Rash macular; Rash pustular; Skin lesion	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~UNKNOWN MANUFACTURER~~UNK~~UN~SMALLPOX (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0300429	10/02/2008	VA	0.4			M	10/01/2008	Information has been received on request from the FDA under the Freedom of Information Act concerning a 5 month old male with no previous medical history who on 04-DEC-2007 was vaccinated PO with the third dose of ROTATEQ (lot # 656659/0942). Concomitant vaccine therapy included the third IM dose of DAPTACEL (lot # C2749AA) in the left leg, the first IM dose of FLUZONE (lot # UT2456EA) in the right leg, the third IM dose of PREVNAR (lot # B540168) in the right leg and the third IM dose of IPOL (lot # A0169) in the left leg. There were no other concomitant medications. On 17-DEC-2007, the patient had vomiting and decreased urine output. On 18-DEC-2008, the patient did not have a bowel movement for two days. The patient had a two view abdominal which showed dilated loops of small bowel obstruction and an upper GI which revealed no malrotation and free fluid, favoring intussusception in right mid abdomen. The patient was admitted to the hospital and diagnosed with intussusception. On 19-DEC-2007, after the patient had two hydrostatic enemas that were unable to completely reduce the intussusception, the patient had an exploratory laparotomy and reduction of the intussusception. The patient was discharged from the hospital on 22-DEC-2008, the outcome was not reported. The reporter considered intussusception, bowel movement irregularity, urine output decreased and vomiting to be life-threatening. Lot check results for lot # 656659/0942U: A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements and was released. The original reporting source was not provided. The VAERS ID # is 300429. No further information is available.			Y	Y	Y	5			U	12/04/2007	12/17/2007	13	abdominal X-ray, 12/18/07, two views showed dilated loops of sm. bowel; obstruction; barium enema X-ray, 12/18/07, incomplete reduction of intussusception after two attempts; upper GI series X-ray, 12/18/07, no malrotation, free fluid, favoring intussusception right mid abdomen	OTH	OTH			None		WAES0809USA03657	1						2	Abdominal X-ray; Barium enema abnormal; Bowel movement irregularity; Enema administration; Explorative laparotomy; Intussusception; Small intestinal obstruction; Urine output decreased; Vomiting; X-ray abnormal; X-ray with contrast upper gastrointestinal tract	DTAP~SANOFI PASTEUR~C2749AA~3~IM~LL~DTAP (DAPTACEL)~2|FLU3~SANOFI PASTEUR~UT2456EA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|IPV~SANOFI PASTEUR~A0169~3~IM~LL~POLIO VIRUS, INACT. (IPOL)~2|PNC~PFIZER\WYETH~B540188~3~IM~RL~PNEUMO (PREVNAR)~2|RV5~MERCK & CO. INC.~0942U~3~PO~MO~ROTAVIRUS (ROTATEQ)~2	USA	Life Threatening,Hospitalisation	Influenza
0326696	10/02/2008	LA	8.0	8		F	10/02/2008	Patient started three hours after the Flu Mist was administered with fever of 101.5, body aches, diarrhea, sweats, headache and loss of appetite.  It lasted 36 hours.  The fever returned to normal, but the diarrhea and body aches still persist almost 72 hours later.									Y	09/29/2008	09/29/2008	0		UNK	UNK	None	None	None			1						1	Anorexia; Diarrhoea; Headache; Hyperhidrosis; Pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~unknown~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0326817	10/02/2008	MA	58.0	58		F	09/27/2008	Sore arm - redness									Y	09/18/2008	09/23/2008	5	Unknown	OTH	OTH	Unknown	None	Unknown			1						1	Erythema; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA193BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0326820	10/02/2008	NY	58.0	58		F	09/26/2008	Pt had a 2 inch swelled are at injection site. Area warm to touch. Ice applied and area getting better.									Y	09/26/2008	09/26/2008	0	None	PVT	PVT	MVI, FOSAMAX, calcium, folic acid, methotrexate,	Chronic conditions - No acute	Ampicillin, DARVON			1						1	Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2757AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326823	10/02/2008	CA	41.0	41		F	09/27/2008	Red hot swollen lump										09/25/2008	09/26/2008	1		PVT	UNK			Asthma			1						1	Erythema; Skin warm; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0326824	10/02/2008	TX	49.0	49		F	09/28/2008	Within 4 hours experienced dizziness, nausea, weakness, headache, fever and chills, coughing. Symptoms lasted for approx. 16 hours.									Y	09/27/2008	09/27/2008	0	None	OTH	PVT	None	None	None			1						1	Asthenia; Chills; Cough; Dizziness; Headache; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~~UNK~~GM~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326831	10/02/2008	PA	32.0	32		F	10/02/2008	Received FLUZONE 0.5 ml dose L deltoid at 2:30 pm on 10/1/08. Began to experience severe body aches with muscle spasms of trunk and back 5 hours post injection. Discomfort was so severe it caused pt to cry. Positive chills, no temperature, positive chest tightness. L deltoid site had positive soreness, no swelling, no redness. Advil - tablet 9 pm. Feeling better in am. Symptoms improved. Advised to notify PCP of event.									Y	10/01/2008	10/01/2008	0		PUB	PVT	BCP, YAZ		none			1						1	Chest discomfort; Chills; Crying; Injection site pain; Muscle spasms; Pain	FLU3~SANOFI PASTEUR~U2805AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326838	10/02/2008	GA	26.0	26		F	10/02/2008	THE PATIENT BROKE OUT IN HIVES.									N	10/01/2008	10/01/2008	0	JUST REPORTED SYMPTOMS OF FEVER AND RASH TO THE DOCTOR ON 10/02/2008.	PVT	PVT	SPRINTEC(BIRTH CONTROL) AND OMEGA 3.	IRREGULAR PERIOD AND HIGH CHOLESTEROL.	NONE			1						1	Pyrexia; Rash; Urticaria	FLU3~SANOFI PASTEUR~U2810AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326839	10/02/2008		7.0	7		F	10/02/2008	Patient received the intranasal flu vaccine on 25Sep08. On the same day, her Brother received both the FluMist and a Varicella vaccine. 2 days later, patient developed shingles.									Y	09/25/2008	09/27/2008	2		MIL	MIL		None				1						1	Herpes zoster	FLUN3~MEDIMMUNE VACCINES, INC.~500551P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0326840	10/02/2008	GA	27.0	27		F	10/02/2008	Patient initially presented with generalized body aches and was admitted by medicine service.  She had paresthesias and numbness from the wrist down.  she also had problems with urinary retention, bowel movements and difficulty standing.  she was worked up by neurology and thought to have some sort of Guillian-Barre Syndrome related to receiving a Flu Vaccine.  10/24/08 Reviewed hospita medical records of 11/28-12/06/2007. FINAL DX: transverse myelitis& urinary retention secondary to flu vacccine Records reveal patient experienced generalized body aching esp from lower torso up to mid back, chills, urinary retention, difficulty standing, abnormal gait, constipation, worsening numbness & tingling from waist down. Neuro & uro consults done.  Tx w/IV steroids & I/O caths.				Y	Y	8			Y	11/01/2007	11/27/2007	26	LABS: MRI c/w transverse myelitis.  CT & MRI of brain WNL.  Plts 428(H).  ESR, CSF, CBC, chemistries, ANA, CRP, UA, ECG & CXR all WNL.	UNK	UNK		None	None  Family hx of lung cancer & hypercholesterolemia.			1						1	Bowel movement irregularity; Dysstasia; Pain; Urinary retention	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0326849	10/02/2008	CA		36		M	10/02/2008	Tachycardia, cold, clamy, generalized itching, chattering of teeth 2.5 hours after administering Fluarix.									Y	10/01/2008	10/01/2008	0		UNK	PUB	unknown	not specified				1						1	Chills; Cold sweat; Feeling cold; Pruritus generalised; Tachycardia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA356AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0326850	10/02/2008	CA	24.0	24		M	10/02/2008	Nausea, vomitting, chest tightness, tingling hands, flushed 15 minutes after receiving Fluarix.  Treated with IV fluids, epinephrine, benadryl, zofran, albuterol neb, benadryl in the ED, then admitted into hospital. 10/31/08 Reviewed ER medical records of 10/02/2008. FINAL DX: no d/c summary available.  H&P states: anaphylactic reaction to flu shot Records reveal patient experienced chest tightness, nausea, emesis, flushed, heart rate increased, redness, skin warmth, itching, blood pressure elevated.  1st time flu shot.  Tx w/epi, nebs, benadryl & steroids.  Had recurrence of symptoms.  Admitted for overnight observation.  Developed HA next day & seen in ER again, tx w/pain meds & steroids.					Y	1			Y	10/01/2008	10/01/2008	0	LABS: EKG c/w sinus tachycardia.  CBC, chemistry & CXR WNL.	UNK	UNK	unknown	not specified	no allergy listed to flu vaccine, not previously vaccinated  PMH: asthma, controlled w/prn inhaler used infrequently.			1						1	Chest discomfort; Flushing; Nausea; Paraesthesia; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA356AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0326853	10/02/2008	CA	87.0	87		F	10/02/2008	Resident received flu vaccination at 1:30 pm on September 30,2008. The morning of October 2,2008,6:00 am, resident had seizure like activity lasting 10 seconds. She had jerky movement of upper and lower extremity and had small bite mark on her lower lip.									Y	09/30/2008	10/02/2008	2	Vital signs after seizure like activity were: Temp. 96.8, Pulse 96, Resp. 18, and b/p 118/66.	PVT	PVT	1. Dyazide 1 capsule oral every day, 6pm (tx edema),2. Multivitamin with minerals 1 tablet every day 9:00 am, 3. Paxil 10mg tablet po qd (for depression), 4.  Tyelenol 650mg po q 4 hr prn generalized discomfort	none	Alzheirmer's dementia, old CVA, Depressive disorder, and edema	none~ ()~NULL~~In Patient|unknown~ ()~NULL~~In Sibling1		1						1	Dyskinesia; Mouth injury	FLU3~CSL LIMITED~02249111A~2~IM~~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0326854	10/02/2008	AL	63.0	63		F	10/02/2008	bp 187/88, HR 100+ ~30 MIN AFTER VACINE.        6-7 HOURS LATER, BP 176/88 TO 182/87, HR 97 TO 88OXYGEN SATS 98.  PATIENT WAS RANDOMLY TAKING VERY LARGE BREATHS.  NO SITE REDNESS AND SWELLING									Y	10/02/2008	10/02/2008	0		PUB	UNK		NONE				1						1	Heart rate increased; Hyperventilation	FLU3~CSL LIMITED~0214911a~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0326855	10/02/2008	IL	25.0	25		M	10/02/2008	Patient reported to and was treated at local ER. Pt complained of shortness of breath and chest pain following Flumist administration. Symptoms started shortly after inhalation of Flumist and continued to progress. Local ER evaluated as dehydration and brochospasm secondary to Flumist. Treated with nebulizers and steroids and released.				Y					Y	09/07/2008	09/07/2008	0		MIL	MIL		none	morphine allergy, past medical history: lasik eye surgery 2005, ORIF Left ankle 1998			1						1	Bronchospasm; Chest pain; Dehydration; Dyspnoea	FLUN3~MEDIMMUNE VACCINES, INC.~500551P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0326857	10/02/2008	CA		44		F	10/02/2008	Experienced coughing, clammy, itching.  Treated with IV fluids, claritin.  Patient went back to work in the hospital and was fine in the AM of 10/2/08.				Y					Y	10/01/2008	10/01/2008	0		UNK	PVT	unknown	not specified	No stated allergy to influenza vaccine			1						1	Cold sweat; Cough; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA356AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0326858	10/02/2008	CA		46		M	10/02/2008	Experienced rash, bumps, flushing, headache.  Symptoms started one hour after vaccination.  Treatment included benadryl IV, solumedrol IV.  Left work to go home after being seen in the ED.				Y					Y	10/01/2008	10/01/2008	0		UNK	PVT	Unknown	not specified	no allergy reported for influenza vaccine			1						1	Flushing; Headache; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA356AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0326859	10/02/2008	IL	25.0	25		F	10/02/2008	Paresthesia to L side of face, L arm, and L leg.  Led to flushing, palpitations and dyspnea.				Y					Y	10/01/2008	10/01/2008	0	Blood test (unknown type) NL, EKG NL	UNK	PVT	Yazmine, Centrum Multivitamin	No	Allergy to Vicodin			1						1	Blood test normal; Dyspnoea; Electrocardiogram normal; Flushing; Palpitations; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0326862	10/02/2008	CA		24		M	10/02/2008	Experienced claminess, itching, teeth/jaw shaking.  Symptom onset approximately 3.5 hrs after vaccination.  Rash developed at 0115 on 10/2/08 and employee went to ED.  Treatment included saline, benadryl, solumedrol, tagmet.  Employee sent home after ED visit.				Y					Y	10/01/2008	10/01/2008	0		UNK	PVT	unknown	not specified	no allergy listed to influenza vaccine			1						1	Chills; Cold sweat; Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUAA356AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0326863	10/02/2008	OH		33		F	10/02/2008	9am vaccine for influenza and received depo-provera injection. 2 hours later got pleurisy pain in right chest and back with short of breath. no itching or hives but felt throat and chest tightness. VS were ok except hyperventilation. treated with benadryl,solumedrol ativan and nubain. stable in er for over 2 hours so released, thorasic back pain only.				Y					U	10/02/2008	10/02/2008	0	WBC 10.3 with 80 seg, 9 bands. D-dimer 300 (0-230)	PVT	PVT	none		ibuprofen  hives			1						1	Back pain; Chest discomfort; Dyspnoea; Fibrin D dimer increased; Hyperventilation; Neutrophil count; Pleuritic pain; Throat tightness; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~unknown~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0326864	10/02/2008	CA		89		F	10/02/2008	Inpatient administered vaccine at 1700, developed nausea and chest pain at 2300.  Patient given zofran and tylenol - symptoms abated.  Patient with afib, copd, DM, HTN, CRF, UTI.  Beta-blocker stopped on 9/30/08.									Y	10/01/2008	10/01/2008	0	assess for Chest pain at 1800 and 1820 and pt had no complaints.	PUB	PVT	Starlix 120 mg at 1800, Ancef 1gm at 2000, Lispro 2 units at 2200.	admitted 9/24/08 with UTI and uremia	NKA, COPD, Afib, DM, HTN, CRF			1						1	Chest pain; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA356AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0326865	10/02/2008	CA	40.0	40		F	10/02/2008	Aprrox 90 min after Flu shot pt called in stating she was red in face arms and chest. No SOB but eyes slightly swollen. She drove herself to the ER locally.				Y					Y	10/02/2008	10/02/2008	0	Per ER	PVT	PVT	Synthroid, Vitamins	None	PCN,codeine,e-mycin			1						1	Erythema; Eye swelling	FLU3~SANOFI PASTEUR~U2784EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0326866	10/02/2008	NY	28.0	28		F	10/02/2008	I received the vaccination at work, from health care providers where administering the shot there. The shot was given to me in my left arm at about 8:40 a.m. on Oct. 1, 2008. Immediately after receiving the shot, my arm was sore. As the day went on, I began to feel aches in my back and legs. These aches intensified throughout the night, and were accompanied by fever, sweats and chills. The worst of my symptoms seem to have abated by about 8 a.m. on Oct. 2, 2008. I did not go into work, however, as I have been exceptionally tired all day. I have slept most of the day, and only my upper back remains a little stiff. I took NyQuil and Ibuprofen to help reduce the fever and aches. I did not see a doctor, as I read on the CDC Web site that my symptoms sometimes do occur after getting a flu shot. I also have felt gradually better throughout the day. If I had not improved, I would have seen a physician.									U	10/01/2008	10/01/2008	0		UNK	UNK	Ortho-tricyclen lo	none	none			1						1	Chills; Fatigue; Hyperhidrosis; Hypersomnia; Limb discomfort; Musculoskeletal stiffness; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~Unknown~2~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0326878	10/02/2008	OH	3.0	3		M	10/02/2008	FLU vaccine given yesterday (10/1/08) at approx 1540. Last night awoke crying with pain at injection site. Today thigh swollen from site to knee and buldase over knee. Slightly afebrile, able to walk without difficulty.									Y	10/01/2008	10/01/2008	0		PVT	PVT			milk protein allergy, Gastrooesophageal reflux			1						1	Crying; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U3762AA~5~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326882	10/02/2008	TX	52.0	52		F	10/02/2008	Oculo- Respiratory syndrome symptoms, sore throat, cough, tightness of breath, bilateral red/tearing eyes with conjunctivitis like characteristics plus fever (100.6 -101) occurred starting one hour after injection and braking 6 hours after injection. Overview faxed to VAERS. She quoted the Guillain-Barre Syndrome.									Y	10/01/2008	10/01/2008	0	None	OTH	UNK	LEVOXYL daily; FEMHRT daily	None	Seasonal allergies (rhinitis/sinusitis); Postmenopausal.			1						1	Conjunctivitis; Cough; Dyspnoea; Lacrimation increased; Ocular hyperaemia; Oculorespiratory syndrome; Pharyngolaryngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U2741AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326884	10/02/2008	NY	71.0	71		F	10/01/2008	Redness, warmth, mild edema to site/upper arm.				Y						09/29/2008	09/30/2008	1	None	PVT	PVT	FOSAMAX 70 mg Q wk -  PRILOSEC OTC 20 mg QD	None	None			1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~Af11a193aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~06194~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0325803	10/03/2008	NE	3.0	3		M	09/22/2008	A serious, spontaneous report of CHANGE IN SENSORIUM, EYES BECAME GLAZED OVER, ERYTHEMA and HIVES has been received from a nurse concerning a three-year-old male, subsequent to FLUMIST. The patient's medical history was not reported. On 18-Sep-2008, the patient concurrently received FLUMIST and MMR vaccines. Approximately ten minutes after receipt of FLUMIST and MMR vaccines, the patient experienced a change in sensorium, eyes became glazed over, erythema on neck and chest, and hives on trunk. An injection site reaction on the MMR site of administration was also noted. The patient was treated with epinephrine and BENADRYL. He was transported to the emergency room where he was monitored for four hours and then released. The outcome of the events was not reported. The sponsor considered the events medically important.									U	09/18/2008	09/18/2008	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0007150	1						2	Blister; Conjunctival hyperaemia; Depressed level of consciousness; Erythema; Urticaria; Depressed level of consciousness; Erythema; Injection site reaction; Staring; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500544P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~MERCK & CO. INC.~0812X~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500544P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~2|MMR~UNKNOWN MANUFACTURER~0872X~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~2	USA		Influenza
0326975	10/03/2008	MA				F	09/17/2008	Patient was administered GARDASIL (her second dose) as well as FLUZONE flu shot. Patient experienced fever, shakiness, weak, nausea and dry heaving. patient said she had a similar reaction with her first shot of GARDASIL, but much less severe.									U		09/17/2008			UNK	UNK						1						1	Asthenia; Nausea; Pyrexia; Retching; Tremor; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~~2~UN~UN~HPV (GARDASIL)~1	USA		Influenza
0326984	10/03/2008	MI	91.0	91		F	10/03/2008	Influenza Vaccine Lot# 8897 Exp. Date 6/30/09 from Novartis given in right deltoid on 10/2/08 approximately 2pm. Today has rash on upper right deltoid above vaccine site and red rash on trunk.  No itching noted. Aefebrile. Dr. aware and ordered 25mg Benadryl.				Y					U	10/02/2008	10/03/2008	1	DR. ORDERED BENEDRYL 25MG NOW AND ONE IN 6 HOURS IF RASH CONTINUES.  MONITOR VITALS.	UNK	UNK	B12 250 QD, MTV, TYLENOL, LEVOTHYROXINE 50 MCG, CELEXA 20 MG QD, REQUIP 3 MG TID, SINEMET 50/200MG BID, NAMENDA 10 MG BID, FORTICAL 200U QD	NONE	DEMENTIA WITH PARKINSON'S, GERD, HYPOTHYROIDISM, OSTEOPOROSIS, ANMEIA			1						1	Injection site rash; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89979~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0326985	10/03/2008	MA	68.0			M	10/03/2008	Patient had fever of 101.2 starting in the evening. Took 2 tylenol at 8 12 and 4am. Temperature returned to normal at 9am on Friday.									Y	09/02/2008	09/02/2008	0		UNK	UNK						1						1	Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0326990	10/03/2008	NY	57.0	56		F	10/03/2008	patient noted bloodshot eyes, puffy face at bedtime at about 11pm									Y	10/01/2008	10/01/2008	0		PUB	UNK						1						1	Ocular hyperaemia; Swelling face	FLU3~SANOFI PASTEUR~U2766AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326991	10/03/2008	WI	1.5	1	.5	F	09/30/2008	none, 18 month old was given o.5cc of fluzone in right leg. CDC notified and was told no serious adverse reaction. Child may have increased local reaction at injection site. Also instructed that child recieve 0.25cc in 4 weeks from initial injection.										09/30/2008				UNK	UNK						1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326993	10/03/2008	NY				F	10/03/2008	Noted itchy eyes and extreme fatigue about 5hrs after vaccine									Y	10/01/2008	10/01/2008	0		PUB	UNK						1						1	Eye pruritus; Fatigue	FLU3~SANOFI PASTEUR~U2766AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326994	10/03/2008	NY	27.0	27		F	10/03/2008	noted headache, blood shot eyes 1/2hr after vaccine									Y	10/01/2008	10/01/2008	0		PUB	UNK						1						1	Headache; Ocular hyperaemia	FLU3~SANOFI PASTEUR~U2766AA~5~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0326999	10/03/2008	TX	28.0	28		F	10/03/2008	Area of injection red the size of a half dollar, red and warm to touch.  Benadryl 25 mg Po one time given									U	10/01/2008	10/02/2008	1		PUB	UNK	none known	no	none			1						1	Injection site erythema; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88635~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0327000	10/03/2008	TX	56.0	56		F	10/03/2008	Pain, inflammation, reddness, warm to touch at area of injection...55 mm in diameter.  Gave Benadryl 25 mg PO one time									N	10/01/2008	10/02/2008	1	none	PUB	UNK	none	no	no			1						1	Injection site erythema; Injection site inflammation; Injection site pain; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88635~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0327001	10/03/2008	TX	63.0	63		F	10/03/2008	injection site red, inflammed, warm to touch, and painful size between quarter and half-dollar. Benadryl 25 mg Po one time given									N	10/02/2008	10/03/2008	1	none	MIL	UNK	none	no	no			1						1	Injection site erythema; Injection site inflammation; Injection site pain; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88635~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0327003	10/03/2008	WA	69.0	69		F	10/03/2008	Fever, pain, erythema and warmth of lower arm (not at injection site)									Y	09/30/2008	10/01/2008	1		PVT	PVT	simvistatin 40 mg daily, aspirin 81 mg daily	not well controlled asthma	asthma, hyperlipidemia, osteoarthritis, asplenia, osteopenia			1						1	Erythema; Pain in extremity; Pyrexia; Skin warm	FLU3~SANOFI PASTEUR~u2759aa~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0224x~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327004	10/03/2008	CA	51.0	51		F	10/03/2008	Difficulty breathing, Asthma symptoms, wheezing.									Y	10/02/2008	10/02/2008	0		PUB	PVT	n/a	n/a	n/a			1						1	Asthma; Dyspnoea; Wheezing	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0327036	10/03/2008	NV	78.0	78		M	10/03/2008	Swelling of injection site.									Y	09/28/2008	09/28/2008	0		OTH	PVT		Swelling of inj. site				1						1	Injection site swelling	FLU3~SANOFI PASTEUR~42742AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327037	10/03/2008	MA	14.0	14		F	10/03/2008	Dose of Tdap given after patient had received a previous dose of Tdap 8-11-06 (provider thought that a Td was given on that date).  Patient complained of site tenderness.									U	10/03/2008	10/03/2008	0	None	PVT	PVT	None	None	None			1						1	Inappropriate schedule of drug administration; Injection site pain	FLUN3~MEDIMMUNE VACCINES, INC.~500541P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0548X~1~UN~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2734AA~1~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C3030AA~2~UN~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~0954X~2~UN~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0327038	10/03/2008	CO	35.0	35		F	10/03/2008	None stated									Y	10/02/2008	10/02/2008	0		OTH	PVT	Unknown	None	None			1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0990U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327039	10/03/2008	CO	78.0	78		M	10/03/2008	Sever pain all the way down arm and swelling at injection site to size of grapefruit- 24 hours after swelling is down but still present, pain is improved but still present.									Y	10/02/2008	10/02/2008	0		OTH	PVT	Unknown	None	None			1						1	Injection site swelling; Pain in extremity	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0990U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327040	10/03/2008	CA	69.0	69		F	10/03/2008	1.5 inches bruise at injection site.									Y	09/26/2008	09/27/2008	1	None	OTH	OTH	Unknown	Unknown	Unknown			1						1	Injection site haematoma	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327042	10/03/2008	AL	45.0	45		F	10/03/2008	Approx. 8-9 hrs after receiving shot, I woke up with my lips, tongue, eyes, and other tissues in mouth swollen. It was hard to swallow and getting hard to breath. Went to ER where the gave me antihistaminic and Steroid shots.				Y					Y	10/01/2008	10/02/2008	1		OTH	PVT		None	None			1						1	Dysphagia; Dyspnoea; Eye swelling; Lip swelling; Oedema mouth; Swollen tongue	FLU3~SANOFI PASTEUR~U2761AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0327045	10/03/2008	UT	74.0	74		M	10/01/2008	Arm started to ache and when woke up couldn't move arm				Y					U	09/30/2008	09/30/2008	0		OTH	PVT		None	None			1						1	Injected limb mobility decreased; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~089745~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0554U~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0327047	10/03/2008	MA	37.0	37		F	10/03/2008	Red, swollen, warm to touch left upper arm size id a softball.  Started on BACTRIM D5 800-160 1 po bid				Y					U	10/01/2008	10/02/2008	1		PVT	UNK		None	None			1						1	Erythema; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U2768AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~055U~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C3029AA~1~IM~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0327048	10/03/2008	VA	46.0			F	09/26/2008	Fever, chills, body aches, N/V X 3 days missed work (FLUMIST) X yrs. Flu vaccine - Inj. site stays red and swollen, tender for whole week.									Y					MIL	MIL						1						1	Activities of daily living impaired; Chills; Injection site erythema; Injection site pain; Injection site swelling; Nausea; Pain; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0327010	10/04/2008	OH	1.25	1	.3	M	10/04/2008	4 X 4 cm area of erythema and firmness, (R > L)no fever, no irritability.  Keflex X 7 days, tylenol prn, cool compress									Y	09/30/2008	10/01/2008	1	none	PVT	PVT	none	no	mild gross motor delay			1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~UT2787CA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0401X~4~IM~LL~HEP B (RECOMBIVAX HB)~1|PNC~PFIZER\WYETH~C68309~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0327011	10/04/2008	FL	72.0	72		F	10/04/2008	Approximately 7 hours after injection, noted soreness at site followed by severe discomfort down entire left arm and inability to use hand or fingers without pain. This persisted throughout the night; I took Aleve (220 mg. Naproxen sodium) followed by 1 Extra strength Tylenol about every 2 hours during the night.  I had to use my right arm to move my left arm trying to find a comfortable position.  There was no swelling or redness at the site.  I also was experiencing sharp jabbing pains in my right leg, but have no idea if this was related.  There is some abatement of the pain at this time, which is 21 hours after injection and I am able to use my fingers, but raising the upper arm is still painful.										10/03/2008	10/03/2008	0		UNK	PUB	Synthroid,Premarin,Cycrin,Android,Fosamax,Lipitor					1						1	Injected limb mobility decreased; Injection site pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~aflla175aa~6~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~1541U~1~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0327012	10/04/2008	FL	73.0	73		F	10/04/2008	Rash and hives across upper chest area also small infammation on corner mouth									U	10/03/2008	10/03/2008	0		PUB	PUB	Generic Fosimax					1						1	Inflammation; Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0327014	10/04/2008	OR	48.0	48		F	10/04/2008	Pt received flu mist and shortly after had a severe migrane headache, chills, nausea and ultimately vomited x1.  Given Aleve 440mg and 1 ES Tylenol per DO order.  Placed in a darkened room and allowed to sleep for one hour.									Y	10/04/2008	10/04/2008	0	NA	MIL	MIL	NA	NA	NA			1						1	Chills; Migraine; Nausea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500563P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0327015	10/04/2008	WA	22.0	22		F	10/04/2008	PATIENT FAINTED APPROXIMATELY 5 MINUTES AFTER RECEIVING SHOT. SHE REGAINED REGAINED CONSCIOUSNESS SHORTLY THEREAFTER (WITHIN 1-2 MINUTES). PT HIT HER HEAD AS SHE FELL CAUSING A LACERATION APPROXIMATELY 1/2 TO 3/4 IN LENGTH. PT WAS TAKEN TO A LOCAL URGENT CARE CENTER FOR TREATMENT.				Y					U	10/04/2008	10/04/2008	0		UNK	PVT	UNKNOWN	NONE	ALLERGIC TO SULFA DRUGS - NO OTHER CONDITIONS REPORTED AT TIME OF ADMINISTRATION			1						1	Head injury; Immediate post-injection reaction; Skin laceration; Syncope	FLU3~SANOFI PASTEUR~U2802AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0327211	10/04/2008	WA	61.0	61		F	10/06/2008	Muscle and joint discomfort throughout lower body, chills.  Have taken Tylenol with some relief - feel better today compared to yesterday.									N	10/01/2008	10/03/2008	2	None	UNK	PVT	Vitamins	3-days prior-over a cold	None			1						1	Arthralgia; Chills; Musculoskeletal discomfort	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327016	10/05/2008	MD	54.0	54		M	10/05/2008	Extreme tenderness and pain when touched at injection site and surounding area within 12 hours of Pneumonia Vacine injection.  High fever 101 Degrees F will full body chills within 24 hours of injection.  Big RED irregular shaped patch (hot to the touch resembling a 2nd degree sunburn) 4 by 4 in size at injection site showed up 48 hours after injection.  72 hours after injection temperature drops to 100 Degrees F and full body chills stop.  Patient took 800 MG of Advil three times a day starting 12 hours after injection.  Patient received a FLU Vacine in the right arm and a Pneumonia Vacine in the left arm.  There was no reaction from the flu shot.  The extremine reaction listed above was from the Pneumonia Vacine and occured in the left arm, e.g., tenderness, pain, red patch all ocured in the left arm (the pneumonia vacine was given in the left arm).  You will have to contact my doctors office to find out the manifacture and lot number for the vacines I received.									Y	10/01/2008	10/02/2008	1	None to date.	PVT	PVT	Synthroid 75 mcg once a day at 10PM.  1 Mg of Lorzapan (Generic Avatan) once a day at 9PM.  800 mg of Advil 3 times a day after high fever began.	None	Hypothyroidism.  Mild algery to mold, only noticeable when patient has a cold or flu.	None~ ()~NULL~~In Patient|Unknown~ ()~NULL~~In Sibling1		1						1	Chills; Injection site erythema; Injection site pain; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~Unknown~7+~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~Unknown~1~IM~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0327017	10/05/2008	OH	99.0	99		F	10/05/2008	Over the three days since the shot was administered I have suffered from disorientation, nausea,  and diarrhea.  On October 5, 2008 it became necessary to call the paramedics because I had a brief coma type event.  I continue to have headaches, general body aches, and difficulty in mobility.  The paramedics indicated that they felt the problem came from the shot.  I am stille xperiencing a variety of pains, difficulty in maintaining the food that I eat and in my ability to walk safely.  No other vaccines were given on this date nor had there been any other vaccines given within the past year.  The only medicines that I take are for high blood pressure and for a thyroid deficiency.  Prior to the vaccine all of my vital signs were excellent based on testing that had been done in early September. PLEASE NOTE THAT IN ERROR I ENTERED  AN ITEM IN BOX 14.  NONE SHOULD HAVE BEEN ENTERED BUT THE FORM WILL NOT PERMIT ME TO REMOVE IT.				Y					U	10/02/2008	10/02/2008	0		UNK	PVT	Baby Aspirin, Levothyroxine 50mcb	None.	Elevated Blood Pressure, Asthma, Thyroid supplements. Crestor, Blood Pressure Medicine	None~ ()~NULL~~In Patient		1						1	Coma; Diarrhoea; Disorientation; Dyspepsia; Gait disturbance; Headache; Mobility decreased; Nausea; Pain	FLUX~UNKNOWN MANUFACTURER~~1~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0327019	10/05/2008	IN	69.0	69		F	10/05/2008	As an asthma patient I am faithful in getting the flu shot yearly. I have never had a bad reaction, nor a case of flu after having the shot. I got the shot on 9/29/2008. The next day I felt SOB and lethargic. I developed a frequent, productive cough. By 10/3/08 I was running a fever. Sputum was dark green, SOB increasing. Because of my history of respiratory problems, I started prescription cough medicine and antibiotics that day. They have been effective and I am slowly improving.  This may have been an adverse event or simply an unlucky coincidence.									Y	09/29/2008	09/30/2008	1		UNK	UNK						1						1	Asthma; Dyspnoea; Lethargy; Productive cough; Pyrexia; Sputum discoloured	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0327020	10/05/2008	OH	68.0			M	10/05/2008	Immediately I felt like I was passing out. After resting for a few minutes I was able to resume my activities but I had muscle soreness and some feeling of mobility issues.  After about 2 hours I became nauseated and my skin was tender to the touch.  I had diarrhea for the next several days.  On the evening of the day I had the vaccine, I experienced chills and found it difficult to warm up and get comfortable.  I continued to have some mobility issues and a headache that would not respond to aspirin. Today I am able to eat without difficulty and I no longer have the headache or feeling of nausea. But, I remain significantly tired and I still feel some weakness in my muscles.									Y					UNK	PVT	Lipitor (10), Baby Aspirin, and fish oil tablet supplements	None	The only health problem is an elevated level of cholesterol	none~ ()~NULL~~In Patient		1						1	Chills; Diarrhoea; Fatigue; Headache; Immediate post-injection reaction; Mobility decreased; Muscular weakness; Myalgia; Nausea; Presyncope; Skin discomfort	FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0327021	10/05/2008	KY	33.0	33		F	10/05/2008	Pt recieved a flu shot, Afluria, in the right arm and a pnuemonia shot, Pneumovax, in the left arm at the Kroger pharmacy around noon on Saturday, 10-4-08.  Pt called back at 5:30 pm that day to tell us that she was having a lot of pain and swelling in her left arm and that she could feel a golf ball size knot where the shot was given.  I checked the consent form and told the pt that she had recieved the pneumo shot in the left arm and that it sounded to me like she was having an allergic reaction.  I advised the pt to immediately seek treatment from a medical doctor at the instant care center or the hospital ER.  I gave the pt my cell phone number and told her to call me later and let me know how she was.  Pt was treated that night at the ER for an allergic reaction to the vaccine.				Y					Y	10/04/2008	10/04/2008	0		UNK	UNK			Pt informed us that she has a latex allergy and we did use non-latex gloves.			1						1	Hypersensitivity; Injection site mass; Oedema peripheral; Pain in extremity	FLU3~CSL LIMITED~02349111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~0554U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0327024	10/05/2008	CA	26.0	26		F	10/01/2008	PATIENT HAD GENERALIZED VACCINIA ONSET 11 DAYS AFTER VACCINATION.				Y					U	09/16/2008	09/29/2008	13	PATIENT SEEN IN URGENT CARE AND REFERRED TO DERMATOLOGY CLINIC.  PUT ON CONVALESCENT LEAVE FOR 1 WEEK.	MIL	MIL	NONE	NO	N/A			1						1	Activities of daily living impaired; Vaccinia; Vaccinia	ANTH~EMERGENT BIOSOLUTIONS~FAV178~1~SC~RA~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500547P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~EMERGENT BIOSOLUTIONS~VV04-003A~2~OT~LA~SMALLPOX (ACAM2000)~1|ANTH~EMERGENT BIOSOLUTIONS~FAV178~1~SC~RA~ANTHRAX (BIOTHRAX)~3|FLUN3~MEDIMMUNE VACCINES, INC.~500547P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3	USA	Emergency room visit	Influenza
0327025	10/05/2008	CA	1.17	1	.2	M	10/05/2008	My son had a very high fever that was not controlled well with tylenol. it rose to a temperature of 104 and my son had a febril seizure in a store. it was the scariest thing that could happen to a parent and child. my son had the look of fright on his face and quickly went in to a seizure. we were taken to the nearest hospital by ambulance. his lips had turned blue and he was not responding. i thought i was losing my baby. that flu shot gave him a terrible fever that was too much for his body to handle. thank god that my son survived that and i still have him!				Y					Y	10/01/2008	10/03/2008	2		PVT	UNK						1						1	Cyanosis; Febrile convulsion; Pyrexia; Unresponsive to stimuli	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0327121	10/06/2008	CA	42.0	42		F	10/03/2008	Fever, chills, myalgias, congestion.									Y	09/29/2008	09/30/2008	1	None	PVT	PVT						1						1	Chills; Myalgia; Pyrexia; Upper respiratory tract congestion	FLU3~SANOFI PASTEUR~U2764AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327122	10/06/2008	FL	47.0	47		F	09/30/2008	Phoned pharmacy day after receiving vaccination to report aggravation of bursitis and immobility of left arm.				Y					Y	09/29/2008	09/30/2008	1		OTH	PVT			Shoulder injury due to car accident - allergy to Phenergan			1						1	Bursitis; Condition aggravated; Injected limb mobility decreased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0327127	10/06/2008	KY	64.0	64		F	10/02/2008	Patient received the vaccine on 10/1/2008.  After she returned to work, had shortness of breath, tachycardia.  School nurse (work place) checked her and BP elevated 144/92.  Episode lasted 30 minutes and resolved on it's own.  No local reaction noted.  Patient called doctor just as FYI.										10/01/2008	10/01/2008	0	None	UNK	UNK						1						1	Blood pressure increased; Dyspnoea; Tachycardia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA156AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0327166	10/06/2008	NC	52.0	52		F	10/06/2008	Chills, Fever and body aches x4 hours.  12 hours after Influenza Vaccination.									Y	10/03/2008	10/03/2008	0	None available	PVT	PVT	Allegra, Benicar	None	HTN			1						1	Chills; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88637~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0327168	10/06/2008	NC	60.0	60		M	10/06/2008	Onset severe chills, body aches, fever of 102 seven (7) hours after receiving influenza vaccine									Y	10/03/2008	10/03/2008	0		PVT	UNK	Metformin, Flomax, Allegra, simvastatin, Avalide, Norvasc, Toprol XL,	None	Hypertension, Non-insulin dependent diabetes, BPH, environmental allergies			1						1	Chills; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2745AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327170	10/06/2008	MI	5.0	5		M	10/06/2008	Mom called at 0015 regarding 5 year old, who received influenza shot earlier in the day, with complaints of headache and fever, also vomited x 1.  No diarrhea.  No recent illnesses in family. No photophobia.  Denies sore throat.  Is not irritable or lethargic. No rash.  Discussed most likely is coming down with viral illness, unlikely that due to flu shot.  Rec ibuprofen or tyelonol, and rest.									Y	10/04/2008	10/04/2008	0		PVT	PVT		None				1						1	Headache; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2760AA~7+~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327171	10/06/2008	VA	0.5	0	.6	F	10/06/2008	MOM REPORTS FEVER BEING 105. PT'S TEMP 101.9 WHILE IN OFFICE.									Y	09/16/2008	09/19/2008	3		PVT	PVT		NONE	NONE			1						1	Pyrexia	DTAP~SANOFI PASTEUR~C2958AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2782EA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF449AA~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C68312~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0470~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0327172	10/06/2008	TX	41.0	41		F	10/06/2008	Shot received Oct. 1, 2008.  Chest pain the morning after the shot 10/2.  On 10/3 around 11 am, I started getting a sharp pain in my left shoulder blade that radiated around to my left breast.  It kept getting worse and nothing helped except laying down.  It was hard to breathe because it hurt so much.  I took Gas-X, Tums, Advil and Xanax over the next few hours.  A co-worker who also had the flu shot reported the symptoms to me around 5pm that day.  We both felt better mentally after talking to each other because we had both considered going to the emergency room thinking we were having heart attacks.   On Sat. 10/4 when I got up, the pain was even worse like a knife was in my back.  I took 2 Advil and that helped.  I took more Advil all day and a little on Sunday, 10/5. It still hurts today, but I can tell it's getting better.									Y	10/01/2008	10/02/2008	1		UNK	PVT	Lexapro, Klonopin, Singulair, Protonix, Diflucan (one dose for yeast infection - same week)		anxiety, asthma			1						1	Back pain; Breast pain; Chest pain; Dyspnoea; Musculoskeletal pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0327173	10/06/2008	MI	30.0	30		F	10/06/2008	Redness, swelling, pain, and bruising around the injection site accompanied by headache and nausea.  Severe symptoms did not set in until nearly 24 hours after injection and then lasted roughly 48 hours.									Y	10/02/2008	10/03/2008	1		UNK	UNK	Prenatal vitamins	none	penacillin allergy			1						1	Headache; Injection site bruising; Injection site erythema; Injection site pain; Injection site swelling; Nausea	FLUX~UNKNOWN MANUFACTURER~not known~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0327174	10/06/2008	CO	54.0	54		F	10/06/2008	Hives and rash on left forearm. Took antihistamine for 24 hour period to reduce itching. Hives and rash disappeared within 48 hours.									Y	10/03/2008	10/03/2008	0		UNK	PVT		none	sinus allergies			1						1	Pruritus; Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0327175	10/06/2008	MI	7.0	7		M	10/06/2008	Hives developed within 10 minutes of flumist administration. We gave him Benadryl 25mg & topical cortisone cream & they did diminish within one hour's time. No breathing difficulties noted.									Y	10/06/2008	10/06/2008	0		PVT	PUB	Risperdal 0.25mg, 1 bid & 2 hs		S/p Mylomeningocele. Neurogenic bladder. Child is in foster care,we do not have all his medical history yet.			1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500559P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0327176	10/06/2008	NE	74.0	47		F	10/06/2008	Developed a headache within 30 minutes of immunization that lasted for 31/2 days; Body aches upon arising 10/04, 20 hours after immunization. Felt as if she had been hit in the back with a baseball bat.   Joints were painful, fingers, knees, elbows and face were swollen. Four days after immunization, swelling is gone, joints in hands and knees; and back still stiff and sore but improving.  Denies fever or any respiratory symptoms.  Tongue did not swell.  No vomitting; did have diarrhea following immunization on 10/3 and 10/4.  This was the first flu immunization patient has ever gotten.  Allergies:  Demerol, Morphine, oral constast solution, Nubain, feathers and strawberries.  Does not take any medication. Patient called her physician who told her to rest, take Ibuprophen, and call if symptoms got worse or did not improve by 10/6/08. Patient admits to taking Excedrin, Ibuprophen, and Tylenol for the headache and body aches.									Y	10/03/2008	10/03/2008	0	None	PUB	UNK	None	None	Lap cholecystectomy 6/30/08.  Developed a bile leak and peritonitis post-op.  Patient reports allergies to Demerol, morphine, Nubain, and oral contrast.  No physician documentation of these allergies.			1						1	Arthralgia; Back pain; Diarrhoea; Headache; Joint swelling; Musculoskeletal stiffness; Pain; Swelling face	FLU3~SANOFI PASTEUR~U2760AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327177	10/06/2008	OH	38.0	38		F	10/06/2008	Patient began to feel chest tightness, tightness in throat, elevated blood pressure, itching in arm with injection, flushing, agitation, burning on administration. Patient was tachycardic (HR=151) and hypertensive (BP=173/125) on presentation to the Emergency Department. PAtient had already taken 50mg oral diphenhydramine prior to admission. Given 125mg IV methylprednisolone and 20 mg IV famotidine in the ED. Monitored until vitals normalized and symptoms improved.				Y					Y	10/06/2008	10/06/2008	0	EKG performed.	PUB	UNK	Lo-ogestrel	None	Otherwise healthy. Possible allergy (rash) with amoxicillin, but patient had Mononucleosis at the time			1						1	Agitation; Blood pressure increased; Chest discomfort; Electrocardiogram; Flushing; Hypertension; Injection site irritation; Injection site pruritus; Tachycardia; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA380CA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0327178	10/06/2008	NJ	1.0	1	.0	F	10/06/2008	STAPH INFECTION, FEVER, BOIL, SWOLLEN REDNESS AND SORENESS(INNER THIGH, VAGINAL AREA, AND BUTTOCK AREA),				Y					U	09/15/2008	10/01/2008	16	BOIL WAS LANCED AND ANTIBIOTICS GIVEN.  CULTURE TAKEN.  POSITIVE FOR STAPH.  INFORMED TO CONTINUE ANTIBIOTICS.  - ** I AM UNSURE OF	PVT	UNK	ALSO GIVEN MOTRIN FOR FEVER.	NONE	N/A			1						1	Culture wound positive; Furuncle; Injection site erythema; Injection site pain; Injection site swelling; Pyrexia; Staphylococcal infection; Surgery	FLUX~UNKNOWN MANUFACTURER~~2~~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~RL~HEP A (NO BRAND NAME)~1|MMRV~UNKNOWN MANUFACTURER~~UNK~~RL~MEASLES + MUMPS + RUBELLA + VARICELLA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0327180	10/06/2008	OH	50.0	50		F	10/06/2008	Aproximately one minute post asministration of the vaccine into the left deltoid, pt complained of a fast heartbeat and feeling warm. She felt weak and needed tp lie down. She began twitching but never lost consciousness and was alert. She then developed a few hives on her abdominal wall and face. Her face especially under her chin was swollen. After about three minutes she complained of shortness of breath and wheezing. I treated her with oral benadryl 25mg and zantac 150 mg. Over the next hour her symptoms largely subsided although the next morning she said she felt very achy and still somewhat weak.				Y					Y	10/02/2008	10/02/2008	0	none	UNK	UNK		Mild cold	Allergic to cats- wheezing			1						1	Asthenia; Dyspnoea; Feeling hot; Heart rate increased; Immediate post-injection reaction; Muscle twitching; Pain; Swelling face; Urticaria; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU359BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0327182	10/06/2008	CA	59.0	59		F	10/06/2008	Shingles presented itself approximately 10 days later from Date of Vaccination, which was on 9/20/08.  On 10-1-08, morning shingles were present and confirmed by emergency care and Family Physician.  Investigation was due to Husband broke out with hives on 10-1-08 after being vaccinated on 9/20/08.  The correlation between the two outbreaks resulted in the the vaccination resulted in the outbreak.				Y					N	09/20/2008	10/01/2008	11	10/3/08 and 10/2/08, prescribed medication Acycolvir 800 mg.	UNK	UNK	None	None, very healthy Reported to Pharmacist for Lot. #.	None to influenza Vaccines			1						1	Herpes zoster; Sick relative	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0327183	10/06/2008	AZ	61.0	61		M	10/06/2008	Hives, on 10-1-08, Vaccinated on 9/20/08, adverse reaction same day wife came down with Shingles.									Y	09/20/2008	10/01/2008	11	None Available, Urgent Care viewed hives from vaccination location	UNK	UNK	None	None	None			1						1	Sick relative; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0327184	10/06/2008	OR	46.0	46		F	10/06/2008	Received the shot around 12:30 PM Tuesday Sept 30th. Started sweating around 4:30 and had to go to bed at 6:30PM. Woke up around 2:30 am with temp of 102.6 and shot arm swelled up and head splitting. Temp started going up so husband packed me in ice and gave me thera flu. No change in temp. With ice and acetaminophen could not get out of bed and temp stayed around 102 until Friday. Could only keep ice chips and ginger ale down. By Friday night temp broke and was hovering at 101.5. By Saturday I sweated all day with temp around 100. By Sunday temp was normal but still had a splitting headache but swelling arm went down but continued to be red, blotchy and sore. Started vaginally bleeding out of cycle (never happened before) on Saturday...still bleeding on Monday. Need to go to the eye DR too because it seems like my eyes have changed...do not know yet.									U	09/30/2008	09/30/2008	0	Going for lab tests	UNK	UNK		None	None	~Influenza (Seasonal) (no brand name)~UN~46.70~Patient		1						1	Body temperature increased; Erythema; Headache; Hyperhidrosis; Menstrual disorder; Nausea; Oedema peripheral; Pain in extremity; Rash macular; Visual disturbance	FLUX~UNKNOWN MANUFACTURER~V04.81~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0327186	10/06/2008	GA	26.0	26		F	10/06/2008	Left arm became sore approximately 24 hours after the Td vaccine was administered in Employee Health at the hospital. Approximately 30 hours after the injection, she developed a fever of 101. Took 800 mg of Motrin with little relief. Site began to swell and has localized fever at site of injection.									Y	10/03/2008	10/04/2008	1		PUB	PVT	Lexapro, Yaz, Reglan, Metformin	N/A	PCOS, cat and tree allergies. PCN, Keflex and Codiene allergies.			1						1	Injection site swelling; Injection site warmth; Pain in extremity; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA366AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|TTOX~SANOFI PASTEUR~U2294CA~3~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0327188	10/06/2008	MI	30.0	30		F	10/06/2008	Wheezing on 10/01/08 @ 9 pm Hives on 10/02/08  Site edema, and hot to touch on 10/02/08.  Self administered benadryl and cortisone cream									Y	10/01/2008	10/01/2008	0	none	PVT	PVT	none	none	none	none~ ()~NULL~~In Patient|unknown~ ()~NULL~~In Sibling1|unknown~ ()~NULL~~In Sibling2		1						1	Injection site oedema; Injection site warmth; Urticaria; Wheezing	FLU3~CSL LIMITED~02649111a~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0327190	10/06/2008	NY	50.0	50		M	10/06/2008	Chills, tightness and burning sensation in chest, lethargy appeared 48 hours after vaccine.										10/03/2008	10/05/2008	2		PVT	UNK						1						1	Burning sensation; Chest discomfort; Chills; Lethargy	FLUX~UNKNOWN MANUFACTURER~~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0327192	10/06/2008	MN	3.0	3		F	10/06/2008	The morning after vaccine was given patient had red puffy cheeks, watery eyes, and a funny sounding voice.  There was no medication given, and patient is fine now.									N	10/01/2008	10/02/2008	1	None	PUB	PUB	none	none	none			1						1	Dysphonia; Erythema; Lacrimation increased; Swelling face	FLUN3~MEDIMMUNE VACCINES, INC.~500547p~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0327194	10/06/2008	TX	63.0	63		M	10/06/2008	Received vacine on October 5 at 9:30 AM by a visiting nurse.  At 11:30 A.M. became very dizzy and light-headed, broke out in a sweat and became very pale and weak.  I sat and rested and the symptoms subsided in about 15 minutes.									Y	10/05/2008	10/05/2008	0		UNK	UNK		none	hay fever (tree molds)			1						1	Asthenia; Dizziness; Hyperhidrosis; Pallor	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0327208	10/06/2008	KS	69.0	69		F	10/03/2008	Patient complained of arm hurting - was not able to lift above head the morning after receiving PNE shot.									U	10/02/2008	10/03/2008	1		OTH	PVT						1						1	Injected limb mobility decreased; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0551X~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327209	10/06/2008	KS	72.0	72		M	10/03/2008	Patient complained of arm hurting - very sore and not able to lift very high the morning after injection.										10/02/2008	10/03/2008	1		OTH	PVT						1						1	Injected limb mobility decreased; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0551X~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327210	10/06/2008	TX	3.0	3		M	10/06/2008	Pt's mother denied asthma prior to receiving Flu Meds on 10/208. Mom reported he had cough on Saturday but worsened yesterday; severe cough v SOB. She gave multiple albuterol neb treatments, which helped Per pt's chart, he has asthma attacks wever winter season.									Y	10/02/2008	10/04/2008	2		PUB	OTH		None				1						1	Asthma; Cough; Dyspnoea	FLUN3~MEDIMMUNE VACCINES, INC.~500560P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0327214	10/06/2008	TX	63.0	63		F	10/05/2008	Fri to Sat (Oct 3rd to 4th) - Pt couldn't sleep on left side, sore and little warm and red. Then 4th to 5th, still warm, red decreased now a little more swollen.									N	10/02/2008	10/03/2008	1		OTH	OTH						1						1	Erythema; Oedema peripheral; Pain in extremity; Skin warm; Sleep disorder	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1381U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327215	10/06/2008	AZ	74.0			F	10/06/2008	Sore arm, numbness, tingling									Y	09/16/2008	09/20/2008	4	None	PVT	PVT		None	None			1						1	Hypoaesthesia; Pain in extremity; Paraesthesia	FLU3~SANOFI PASTEUR~U2751AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327216	10/06/2008	FL	1.5	1	.5	F	10/06/2008	Child had febrile seizure on 10/02/08.				Y					Y	09/24/2008	10/02/2008	8	Blood work, Spinal tap - all normal	PVT	PVT		None	None			1						1	Blood test normal; CSF test normal; Febrile convulsion; Lumbar puncture	DTAP~SANOFI PASTEUR~C2999AA~4~UN~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2782DA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A8996~3~UN~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1119X~1~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0327221	10/06/2008	NY	50.0	50		F	10/06/2008	Throat felt swollen; chest tight, hard to breathe. Then hours after felt weak, nauseous, fever									Y	10/02/2008	10/02/2008	0	None	PVT	PVT	None	Runny nose, Some sore throat	Arthritis; Asthma/Allergies; Depression			1						1	Asthenia; Chest discomfort; Dyspnoea; Nausea; Pharyngeal oedema; Pyrexia	FLU3~SANOFI PASTEUR~U2748AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327223	10/06/2008	ID	48.0	48		F		Shot Tues 10/23, headache and muscle ache began Wed 10/4. Severe migraine, pain scale 9 at night. Thurs 10/25 nausea, headache and achiness continuously through the Sunday 10/38. Began to feel better after that.									Y	10/23/2007	10/24/2007	1		PVT	OTH		None				1						1	Headache; Migraine; Myalgia; Nausea; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA310BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0327226	10/06/2008	ID	50.0	50		F	11/30/2007	have had constant ache at injection site since received-at times certain movements would increase pain. No pain is significantly worse without movement.									Y	10/31/2007	11/01/2007	1		PVT	UNK						1						1	Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA310BA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0327228	10/06/2008	ID	21.0	21		F	11/30/2007	Pt came back with c/o a painful deltoid muscle where she received the flu vaccine 1 month ago. Ice/warm packs to arm alternating. Return for recheck.									Y	11/02/2007	11/04/2007	2	None	PVT	OTH	None	None	None			1						1	Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0327024	10/07/2008		26.0	26		F	09/29/2008	Patient has generalized vaccinia onset 11 days after vaccination.				Y					U	09/16/2008	09/27/2008	11		MIL	MIL	None	No	No			1						3	Activities of daily living impaired; Vaccinia; Vaccinia	ANTH~EMERGENT BIOSOLUTIONS~FAV178~1~SC~RA~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500547P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~EMERGENT BIOSOLUTIONS~VV04-003A~2~OT~LA~SMALLPOX (ACAM2000)~1|ANTH~EMERGENT BIOSOLUTIONS~FAV178~1~SC~RA~ANTHRAX (BIOTHRAX)~3|FLUN3~MEDIMMUNE VACCINES, INC.~500547P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3	USA	Emergency room visit	Influenza
0327200	10/07/2008	NV	39.0	39		M	10/07/2008	Fever, chills, severe body ache/muscle fatigue, extreme redness, swelling, blistering and heat at injection site and an approx. 3 inch diameter surrounding site.									U	10/04/2008	10/04/2008	0		UNK	UNK	Lamotrigine, Clonazepam, Effexor, Kadian, Lovastain, Abilify, Ibuprofen 800	None	Depression, Anxiety, Arthritis/joint pain			1						1	Chills; Injection site erythema; Injection site swelling; Injection site vesicles; Injection site warmth; Muscle fatigue; Pain; Pyrexia	FLUX~SANOFI PASTEUR~~4~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0988F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327247	10/07/2008	DE	29.0	29		F	10/03/2008	Case received from a healthcare professional through MIS on 23 September 2008 under the local reference number 08-0440. This case was reported as not-serious. However, upon internal review, it has been upgraded to serious (important medical condition). A 29-year-old female patient, with a medical history of allergies to PC (penicillin) and latex, had received her intramuscular dose of FLUZONE (batch number U2474AA) in the left deltoid, on 19 September 2008. Four hours post-vaccination, the patient's throat started feeling like congestion. As evening progressed, the patient's throat felt tight and under ribs felt constricted. Ten and a half hours post-vaccination, belly button felt knot like, the patient developed fever and lower back pain. Kidneys felt achy and the patient developed amber colored urine. The patient got sweaty and had to change. She went back to sleep after taking MOTRIN. The patient recovered on 20 September 2008.				Y					Y	09/19/2008	09/19/2008	0	Not reported	PVT	PVT			Pre-existing allergies to PC (penicillin) and latex.		200802978	1						1	Back pain; Chest discomfort; Hyperhidrosis; Pyrexia; Renal pain; Throat tightness; Upper respiratory tract congestion; Urine colour abnormal	FLU3~SANOFI PASTEUR~U2474A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0327344	10/07/2008	NC	75.0	75		F		Red, ringworm looking circles all over body 1-2 days after vaccination /severe chronic urticaria-rash then furious weals, lasting 9 months/shivering temp 100, sweating-bed clothes soaked/red eyes, swollen eyelids, body rejecting sun screen lotion, lotions, watch band (metal), stomach (9 months pregnant- looking swollen), diarrhea, depression, anxiety, food sensitivities-kidney beans, banana, sun flower and pine seeds (never allergic before flu shot).									Y	11/20/2007	11/22/2007	2		PVT	UNK	None		Vitiligo-onset at age 26, Bayer Aspirin 1962, 1972-Urticaria			1						1	Abdominal distension; Allergy to metals; Anxiety; Body temperature increased; Chills; Depression; Diarrhoea; Erythema; Eyelid oedema; Food allergy; Hyperhidrosis; Ocular hyperaemia; Urticaria; Urticaria chronic	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA296JA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0327345	10/07/2008	NY	0.2	0	.2	M		Received FLUZONE under 6 months.									U	09/24/2008			None	PVT	UNK		None	None			1						1	Inappropriate schedule of drug administration	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B139AA~1~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2783DA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF462AA~1~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C65935~1~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0327347	10/07/2008	GA	20.0	20		M	10/07/2008	extreme fatigue and muscle soreness slept most of 24 hours ibupropfen helped with soreness but could not stay awake more than 2 hours.									Y	10/04/2008	10/05/2008	1		MIL	MIL		none	no			1						1	Fatigue; Hypersomnia; Myalgia	ANTH~UNKNOWN MANUFACTURER~~UNK~~~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0327349	10/07/2008	AL	11.0	13		F	10/07/2008	Received flu shot yesterday at 3:30pm. This morning woke up around 7am with headache and muscle aches all over. Went on to school but felt so bad that she called home at 9:30am to be picked up. School nurse had taken her temp, and it was 99.5.									U	10/06/2008	10/07/2008	1		PUB	PVT			hypoglycemia, exercise-induced asthma			1						1	Activities of daily living impaired; Body temperature increased; Feeling abnormal; Headache; Pain	FLUX~UNKNOWN MANUFACTURER~~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0327350	10/07/2008	VA	40.0	40		F	10/07/2008	I've saw this pt for sx poss r/t the flu shot from yesterday: Received Flu shot 10/06.  Few hours later (4 hours?)felt her throat was closing up and had difficulty swallowing and blurry vision.  Took Mylanta thinking it might be reflux.  also took a benadryl.  Woke up this am with bilat conjunctival injection and eyes and lips were puffy  Intestinal cramping last night.  Puffiness has resolved on own.  Conjunctival  injection and sense of heavy throat remains.  Had some SOB this AM going up stairs. Had reaction to flu shot 2 years ago with sense that throat was closing but thought it was all in her mind.  Skipped last year flu shot but got the flu so wanted to try it again this year. NKDA or sensitivities.  Hx mild psoriasis or eczema-- so does dad.  Her dad also had an anaphylactic reaction to something, but not a vaccine few years ago- recovered.  Denies f/c/s, recent URI or any illness, hives, rash, syncope, palpitations, or chest pain.  Can swallow now.  EXAM: 139/80, 80, 16, 98.9, LNMP 10/07/08.  Derm:  No hives, rash, skin w % d, good color, Eyes: No periorbital edema.  Bilat conjunctival injection, no tearing, no d/c.  Mouth:  no angioedema  Throat:  post pharnx pink, no swelling, uvula with symmetrical rise.  small amt of pnd.  No stridor with throat auscultation.  Lungs CTA, unlabored, symmetrical rise CV: Normal S1, S2 no m/r/g, RRR									Y	10/06/2008	10/06/2008	0	none	UNK	PVT	On no other meds	no	psoriasis vs eczema in scalp			1						1	Abdominal pain; Conjunctival hyperaemia; Dysphagia; Dyspnoea; Eye swelling; Familial risk factor; Lip swelling; Similar reaction on previous exposure to drug; Throat tightness; Vaccine positive rechallenge; Vision blurred	FLU3~SANOFI PASTEUR~U2789AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327351	10/07/2008	UT	47.0	47		M	10/07/2008	Member received the vaccination on the 4 October 2008. Member came in on 7 oct 2008 and said that the night after receiving the flu Mist that he developed a fever and night sweats that last thought the night. Member as noted that he has swelling on the midial anterial part of the lower leg. Member is take to asprin 2 times a day PCN.									Y	10/04/2008	10/04/2008	0		MIL	MIL	2 baby asprin 2x daily	None noted	Member had pulmonary embolism 2 yrs ago.			1						1	Night sweats; Oedema peripheral; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500551P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0327352	10/07/2008	PA	24.0	23		F	10/07/2008	REDNESS @ INJECTION SITE STARTED 3 DAYS AFTER SHOT									U	10/04/2008	10/07/2008	3		UNK	UNK	NONE	NONE	NONE			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U2806AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1382U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327353	10/07/2008	WI	51.0	51		F	10/07/2008	Chills, total body aches, headache, weakness for 24 hours. Took tylenol and ibuprofen for aches.									Y	10/06/2008	10/06/2008	0		UNK	UNK		none	none			1						1	Asthenia; Chills; Headache; Pain	FLU3~CSL LIMITED~~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0327354	10/07/2008	TX	15.0	15		M	10/07/2008	1.reddness,swelling 2inches in diameter,tenderness at injection site.									Y	10/01/2008	10/03/2008	2	none	PVT	PUB		none	none			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLUN3~MEDIMMUNE VACCINES, INC.~500560p~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~ahavb223aa~UNK~IM~~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~u2732aa~UNK~IM~~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~1017x~UNK~SC~~VARICELLA (VARIVAX)~1	USA		Influenza
0327355	10/07/2008	FL	23.0	23		F	10/07/2008	Received vaccine around 1030 am, began to experience moderate headache and aches within 1 hour. Throat soreness and hoarseness developed within 3 hours of vaccination. Watery, itchy eyes and increase in heart rate (100-110). Received assessment and treatment at ER at 1850, given benadryl 25mg and prednisone 20mg.									Y	10/06/2008	10/06/2008	0		PVT	UNK	none	none	none			1						1	Dysphonia; Eye pruritus; Headache; Heart rate increased; Lacrimation increased; Pain; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~u2744aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327357	10/07/2008	GA	67.0	67		F	10/07/2008	PATIENT HAD REDNESS AND SWELLING DOWN THE LEFT ARM WHICH WAS THE ARM SHE GOT BOTH THE FLU VACCINE AND PNEUMONIA VACCINE.									Y	10/02/2008	10/02/2008	0	NOT APPLICABLE	UNK	UNK				mild redness and swelling~Pneumo (no brand name)~1~~In Sibling1		1						1	Injection site erythema; Injection site swelling; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1382U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327358	10/07/2008	WA	48.0	48		F	09/29/2008	PATIENT GOT THE PNEUMOVAX AND TEH NEXT DAY SHE HAD SIGNIFICANT SWELLING IN THE AREA. IT IS NOW STREAKING AROUND HER ARM. NO FEVER.									Y	09/29/2008	09/30/2008	1	N/A	PVT	PVT	INTERFERON, CYCLOBENZAPRINE, VICODIN, EFFERXOR RX, GEODON, TRAZADONE, TRAMADOL, DIOVAN	NONE	CHRONIC BACK PAIN, HYPERLIPEMIA, BIPOLAR, HEPATITIS C,			1						1	Injection site streaking; Injection site swelling	FLU3~SANOFI PASTEUR~U2745AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0859U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327363	10/07/2008	MN	3.0	3		F	10/07/2008	fast heart beat and fevers up to 104.  Sick for 2 days.									Y	10/02/2008	10/03/2008	1		UNK	UNK	none	none	none			1						1	Heart rate increased; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0327364	10/07/2008	MD	57.0	57		F	10/07/2008	Recieved shot about 11:30 am - soreness at injection site started about 3:00pm.  5:00pm chills, severe body aches and headache started.  Every muscle, joint, nerve ending and hair folicle hurt. It hurt to move.  I took aspirin for the pain and went to bed about 11:00pm - slept until 10:00am next morning, symptoms were gone.  This is the first time I've had a reaction to a flu vaccine.  I have been getting flu shots for about 7 years.									Y	10/06/2008	10/06/2008	0		PUB	UNK		none	none			1						1	Arthralgia; Chills; Headache; Injection site pain; Neuralgia; No reaction on previous exposure to drug; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0327366	10/07/2008	NV	47.0	47		F	10/07/2008	difficulty breathing,  hoarseness, fever, dizziness, weakness, nausea and vomiting, sweeling and redness at the side of injection				Y					U	10/03/2008	10/04/2008	1		PUB	PUB	prozac, pain meds (morphine sulfate, soma, flexeril, elavil,xanax, metadate, topamax, potassium,crestor	mutiple clerosis, pain,				1						1	Asthenia; Dizziness; Dysphonia; Dyspnoea; Injection site erythema; Injection site swelling; Nausea; Pyrexia; Vomiting	FLU3~CSL LIMITED~01049211a~2~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~0622x~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0327369	10/07/2008	OR		27		M	10/07/2008	Hives, severe, with rapid onset; alleviated with liquid Benadryl; no respiratory sx									Y	10/06/2008	10/06/2008	0		PVT	PUB	Depakote	no	Seizure disorder			1						1	Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA183AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0327373	10/07/2008	MA	80.0	80		F	10/07/2008	Pt. c/o rt. upper arm pain shortly after receiving the vaccine and the next day the entire arm was painful. Pt. reported this to nurse on 10/1/08 and pain was subsiding. By 10/2/08 pain was 0.									Y	09/23/2008	09/23/2008	0		PVT	PUB	No	No	Diabetes, Hx. breast cancer, HTN			1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2766AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327377	10/07/2008		20.0	20		F	09/25/2008	A serious investigator initiated study report of trouble breathing has been received from an investigator concerning a 20-year-old female, who is enrolled in a study. Neither medical history nor concomitant medications have been reported. The subject received FLUMIST on 03-Oct-2007. On 06-Oct-2007, the subject experienced trouble breathing. The event was described as severe and that the subject could not work or do usual activities. The event resolved on the same day. The study investigator assessed causality as probably related to FLUMIST vaccine. The sponsor considered the event medically important and agreed with the study investigator's causality assessment.									Y	10/03/2007	10/06/2007	3		OTH	OTH	Concomitant Drug(s) not Reported				MEDI0007173	1						1	Activities of daily living impaired; Dyspnoea; Impaired work ability	FLUN3~MEDIMMUNE VACCINES, INC.~500484P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0327378	10/07/2008		23.0	23		F	09/25/2008	A serious investigator initiated study report of trouble breathing has been received from an investigator concerning a 23-year-old female, who is enrolled in the study. Neither medical history nor concomitant medications have been reported. The subject received FLUMIST on 22-Oct-2007. On 27-Oct-2007, the subject experienced trouble breathing. The event was described as severe and that the subject could not work or do usual activities. The event was considered resolved on 28-Oct-2007. The study investigator assessed causality as probably related to FLUMIST vaccine. The sponsor considered the event medically important and agreed with the study investigator's causality assessment.									Y	10/22/2007	10/27/2007	5		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007174	1						1	Activities of daily living impaired; Dyspnoea; Impaired work ability	FLUN3~MEDIMMUNE VACCINES, INC.~500484P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0327382	10/07/2008	MN	9.0	9		M	10/02/2008	Vomiting and fever for 3 days.  Not seen in clinic, no treatment prescribed.									Y	09/29/2008	09/29/2008	0	None	PVT	OTH	None	None	None			1						1	Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500541P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0327383	10/07/2008	NY	55.0	55		F	10/01/2008	Patient developed a left sided ulnar neuropathy (pain, weakness) that evolved to a left sided brachial plexopathy.									Y	09/16/2008	09/17/2008	1		PVT	UNK		None	None			1						1	Asthenia; Brachial plexopathy; Neuropathy peripheral; Pain	FLU3~SANOFI PASTEUR~U2751AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~UF452CA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0327387	10/07/2008	FL	2.0	2	.7	M	09/29/2008	Following immunizations large swollen knot on thigh around injection site, red and hot, no fever reported. Came to doctor after, no treatment, symptoms resolved.				Y					Y	09/22/2008	09/23/2008	1	none	PVT	PVT		none	none			1						1	Injection site erythema; Injection site mass; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~UT2762DA~3~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0327389	10/07/2008	VA	38.0	38		M	09/29/2008	No adverse effects noted. Pt called and informed of event, possible side effects and to call immediately if he has any side effects.										09/29/2008			None	PVT	UNK		Neck/shoulder pain.	DDD-lumbar, esophageal reflux, asthma, bipolar. Allergy to tetanus.			1						1	No adverse event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89684~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0327393	10/07/2008	NC	57.0	57		M		Fever, chills, malaise, ha, chest pain, dyspnea, edema and erythema of left deltoid area.									Y	10/01/2008	10/02/2008	1		PVT	PVT	Osteo-Bi-Flex tabs; Benadryl	None	Dyspnea; abnormal EKG; compression arthiz			1						1	Chest pain; Chills; Dyspnoea; Erythema; Headache; Malaise; Oedema; Pyrexia	FLU3~SANOFI PASTEUR~U2747AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0224X~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2865AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0327394	10/07/2008	MO	79.0	79		F	10/07/2008	Patient previously exposed to burning corn fields with prior symptoms of sinus, bronchitis and allergies. Afternoon following injection patient began itching in hands and arms. Followed by difficulty breathing. Son took to Emergency Room.				Y					Y	10/06/2008	10/06/2008	0		PUB	UNK		No local reaction	Sinus, Allergies Seasonal , Bronchitis			1						1	Dyspnoea; Pruritus	FLU3~SANOFI PASTEUR~U2768AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0327395	10/07/2008	OR	73.0	73		F	10/07/2008	Received vaccine at 3:00pm on 10/1/08; started feeling chills and fatigue during evening, noting large, reddened area (size of orange) at injection site at hospital.  Continued to feel very tired next day with some improvement of symptoms on 3rd day.  Now on day 6, swelling/redness gone, but still feels tired.									Y	10/01/2008	10/01/2008	0	None	PVT	PVT	Vitamins; Propranolol; ASA 81mg; Vitorin; Loritidine	No	Egg allergy as child; attempted flu vaccine the last 5 yrs without any reaction - until this event.			1						1	Chills; Fatigue; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2759AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0224X~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327397	10/07/2008	WA	19.0	19		M	10/06/2008	Patient with smallpox vaccine on 1 Oct 08.  That evening w/ flesh closed papules on forehead which progressed to back of ears by the morning.  No pustules.  Rash did not improve or worsen.  Seen in clinic on 6 Oct 08.  No other symptoms.  Likely not vaccine related due to timing and recent change of laundry detergent.  No history of atopic dz.									U	10/01/2008	10/01/2008	0	None	MIL	MIL	No	None	None			1						1	Rash; Rash papular	ANTH~UNKNOWN MANUFACTURER~~UNK~~~ANTHRAX (NO BRAND NAME)~1|FLUN3~MEDIMMUNE VACCINES, INC.~SON549P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~UNKNOWN MANUFACTURER~~1~~LA~SMALLPOX (NO BRAND NAME)~1	USA		Influenza
0327398	10/07/2008	ND	60.0	60		M	10/06/2008	Received vaccines on 10/2/08.  Woke up on 10/3/08 - right upper arm red, sore, swollen, warm to touch, chills.  On 10/4/08 patient stated unable to lift arm.  Today redness, swelling, warmth is decreased he states.									Y	10/02/2008	10/03/2008	1		PVT	PVT						1						1	Erythema; Injected limb mobility decreased; Oedema peripheral; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~U2745AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0742X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2899AA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0327405	10/07/2008	CA	0.8	0	.8	F	10/02/2008	Flu shot for child >36 months was given instead of flu shot for 6-36 month child as ordered.									U	10/02/2008	10/02/2008	0	None	PVT	PVT	None	None	None			1						1	Wrong drug administered	FLU3~SANOFI PASTEUR~U2766AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0491~3~SC~RL~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0327408	10/07/2008	IL	77.0	77		F	10/07/2008	Patient developed hives within a few hours of receiving influenza immunization. Required Medrol dose pack to treat. Reports has had flu shot annually for past 24 years no previous problems. Also had hair colored same day. No product change per stylist.										10/02/2008	10/02/2008	0		OTH	UNK		None	Allergy to codeine; history breast cancer			1						1	No reaction on previous exposure to drug; Urticaria	FLU3~SANOFI PASTEUR~U2806AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327409	10/07/2008	MI	48.0	48		F	10/07/2008	Shot administered approx 3 pm; pt complained of burning in arms around 3:20 pm & gave ALLEGRA 180; approx 4:00 pm complained of shortness of breath and tongue was thick; administered EPIPEN; called 911 - and monitored.  EMS came w/in 5 min; patient responsive to epi w/in 5 minutes and recovered w/in 40 min; reused to go to hosp.									Y	10/05/2008	10/05/2008	0		OTH	OTH		No	Not available			1						1	Burning sensation; Dyspnoea; Tongue oedema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89973~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0327410	10/07/2008	IL	66.0	66		F	10/06/2008	Patients arm became swollen several hours after vaccine admin of PNEUMOVAX.  Warm to the touch the next day.  Pt took ibuprofen and BENADRYL on 10/2/08.  Went to MD on 10/3/08 and MD diagnosed as cellulitis and treated w/ CEFTIN.				Y					Y	10/02/2008	10/02/2008	0		OTH	PUB						1						1	Cellulitis; Oedema peripheral; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~7+~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0038U~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0327468	10/08/2008	NE	1.0	1	.0	M	10/03/2008	Pt was 'floppy' per parents starting the evening on the day he received vaccines.  He was not walking as before.  Looking tired.  No fever.  Poor appetite.  Pt more weak after 3 days -> obtained CT & MRI.  MRI showed findings suggestive of acute demyelinating encephalomyelitis. 10/20/08-records received for DOS 9/30-10/5/08-Acute disseminated encephalomyelitis. Evening of vaccinations seemed dazed and had poor oral intake. Temperature 100.4, developed ataxia. Presented to Ed with mental status change and weakness. 1/27/2010 Patient continues with significant speech delays.				Y	Y	5			N	09/25/2008	09/25/2008	0	MRI; lumbar puncture done; CSF Cx neg.; MRI finding on above.  10/20/08-records received-AST 77 and ALT 132. CSF protein 1196, WBCs 70. Electrolytes normal. EEG normal. MRI showed abnormal thalamic signals in left lobe consistent with acute demyelinating encephalomyelitis (ADEM).	PVT	PUB	None	None	None			1						1	Asthenia; CSF culture negative; Computerised tomogram; Decreased appetite; Fatigue; Gait disturbance; Hypotonia; Lumbar puncture; Nuclear magnetic resonance imaging abnormal	FLU3~SANOFI PASTEUR~UT2783DA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB245AA~1~UN~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0667X~1~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C94097~4~UN~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0638X~1~UN~LL~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0327475	10/08/2008	LA	12.0	12		M	10/01/2008	Increased heart rate approximately 2 hour after injection- lasted app 30 minutes-resolved after treatment.									Y	09/30/2008	09/30/2008	0	None	PVT	PVT	STRATTERA 60 gd, CONCERTA 54 gd	None	GERD, Asthma, ADHP	Hives~DTaP (no brand name)~1~0.00~In Patient		1						1	Heart rate increased	FLU3~SANOFI PASTEUR~U2786AA~7+~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U2017AB~6~IM~UN~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0327491	10/08/2008	TX	35.0	35		M	10/07/2008	Patient has complained of waking up at night with shortness of breath on two occasions so far.									U	10/03/2008	10/05/2008	2	None	OTH	PVT	None	None				1						1	Dyspnoea; Sleep disorder	FLU3~SANOFI PASTEUR~U2741AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C3027BA~UNK~IM~LA~TDAP (ADACEL)~1|YF~SANOFI PASTEUR~UF307AB~2~SC~UN~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0327499	10/08/2008	OH	48.0	48		F	10/06/2008	Patient was administered influenza vaccine.  Immediately following, patient had facial swelling, especially around her eyes and right area of neck.  Patient was administered 20mg IV dexamethasone.									Y	10/02/2008	10/02/2008	0		UNK	UNK						1						1	Immediate post-injection reaction; Local swelling; Swelling face	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89910~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0327503	10/08/2008	TX	61.0	61		M	10/08/2008	10-6-08 received pneumococcal vaccine right arm.  That evening upper arm swollen, turned red, was so painful he thought his arm would fall off.  Shortly after, sweats and fever developed, then very sore throat, itchy watery eyes.										10/06/2008	10/06/2008	0	Strep ID negative	PVT	PVT	Warfarin; Rescol; Zetia; Toprol; Altace	None	Prosthetic aortic valve			1						1	Erythema; Eye pruritus; Hyperhidrosis; Lacrimation increased; Oedema peripheral; Pain in extremity; Pharyngolaryngeal pain; Pyrexia; Streptococcal identification test negative	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88907~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0989U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327505	10/08/2008	MI	62.0	62		M	10/08/2008	Patient developed bilateral swelling in hands and wrists.									Y	10/03/2008	10/03/2008	0	None	PUB	PUB	Accuchek Alva Test Strips, Accucheck Multiclix    Lancets, Acyclovir , Advair , ASA , Ativan, Azithromycin, Bactrim, Calcium, Celebrex, Cellcept , Cinnamon, Flaxseed,  Fluocinonide topical, Fosamax , Garlic Glucosamine HCL, Humalog disp pen	No	Lactose Intolerance, Chronic eye GVHD, Vitamin D deficiency ,Dyslipidemia , Hypertension, Respiratory Difficulty . Pneumonia vs. lung GHVD, Early Cataracts OU, Small Chorioretinitis scar OS, Dry Eye Secondary to GVHD, IDDM with mild NPDR, Chronic GHVD skin mouth, Chronic lymphocytic leukemia, Diarrhea and abdominal  pain secondary to gut graft-versus-host disease pathology grade 1, Post-Herpetic neuropathy/neuralgia  - left LE, Hypogammaglobullinemia, S/P allageneic  PBSCT 7/1/03, Attention deficit disorder, Diabetic neuropathy, Chronic Neuropathic Pain, Small bowel obstruction; Probable GVHD lung, Right elbow Olecranon bursitis, Hypothyroidism, Ostepopenia,  Diabetes mellitus			1						1	Joint swelling; Oedema peripheral	FLU3~SANOFI PASTEUR~U2767AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327527	10/08/2008	GA	29.0	29		F	10/08/2008	Miscarriage at 10 weeks gestation within 48 hours of administration									Y	10/06/2008	10/07/2008	1		PVT	PVT	not known	none	10 weeks pregnant			1						1	Abortion spontaneous; Drug exposure during pregnancy	FLU3~SANOFI PASTEUR~U2784KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327530	10/08/2008	SC	48.0	48		F	10/08/2008	DIZZINESS & VISUAL DISTURBANCES W/IN 15-20 MIN AFTER VACCINE, SEVERE ITCHING, REDNESS AND SWELLING OF EARS, EYES, LIPS, EYES FELT GRITTY W/IN 1-2 HOURS AFTER ADMINISTRATION									Y	10/03/2008	10/08/2008	5		PVT	UNK	ESTRATEST, PREVACID 30 MG, HCTZ 25 MG, DOXEPIN 25-50 MG, LOPID 300 MG BID, ZETIA, FIORICET PRN, FLEXERIL PRN, BENADRYL PRN, TYLENOL/IBUPROFEN PRN		FIRE ANTS - ANAPHYLAXIS, FIBROMYALGIA, REFLEX SYMPATHETIC DISTROPHY			1						1	Auricular swelling; Dizziness; Erythema; Eye irritation; Eye swelling; Lip swelling; Pruritus; Visual disturbance	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89975~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0327531	10/08/2008	WV	12.0	12		M	10/08/2008	Dizziness following injection, dizziness approximately 2.5 hours later with paleness and weakness.  Allowed to lie down.									Y	10/07/2008	10/07/2008	0		PVT	PVT		None	seasonal allergies			1						1	Asthenia; Dizziness; Pallor	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MNQ~SANOFI PASTEUR~~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0327532	10/08/2008	PA	5.0	5		F	10/08/2008	Pt received the flu vaccine on 10/6/08 approximately at 1600, during an outpatient office visit with Dr.  The school nurse called mom on 10/7/08 to report that the child's lips had swollen and her face/neck were beet red. No wheezing, no coughing, no trouble breathing or swallowing. Parent denies that child was exposed to anything new, no other new medications, or foods. Edema and redness disappeared on its own.									Y	10/06/2008	10/07/2008	1		UNK	UNK	Provental 2puffs BID, OVAR 40 2 puffs BID, Dornase 1 vial via neb daily, claritin 1 tsp in am, hydroxine 1/2 tsp in pm, Bactrim 3 tsp BID, Singular 4mg daily, Bethanechol 1mg/ml 3xdaily, atrovent nasal spray	asthma followup appt	intrauterine stroke, static encephalopathy, CP, restrictive lung disease, VEPTR, asthma, GERD. allergies: PCN, rash			1						1	Erythema; Lip swelling	FLU3~SANOFI PASTEUR~U2758AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327533	10/08/2008	MI	63.0	63		U	10/08/2008	Client received PPV 23 11am 10/6 by evening L arm shoulder joint swollen and very painful. No redness, denies numbness or tingling. Difficulty sleeping related to pain. Enc ice/heat to arm. Taking motrin. Warm bath. Enc to seek medical care as needed. She did call her doctor. Call 10/8 States improvement of mobility, using ice and heat. Still quite painful									Y	10/06/2008	10/06/2008	0		PUB	PVT		none				1						1	Injected limb mobility decreased; Insomnia; Musculoskeletal pain; Swelling	FLU3~SANOFI PASTEUR~u27454AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0619X~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327534	10/08/2008	OH	58.0	58		M	10/08/2008	Flu vaccine administered at 10:15 am.....over course of afternoon low fever/joint pain/fatigue...7pm fever spiked to 102 degrees....uncontrolable chills/shaking...skin surfaces very hot to the touch....sleep at night was frequently interrupted by chills/shaking or too hot...next am very fatigued/headache/low fever									Y	10/08/2008	10/08/2008	0		UNK	UNK	vasotec 20mg	none				1						1	Arthralgia; Chills; Fatigue; Headache; Pyrexia; Skin warm; Sleep disorder; Tremor	FLU3~SANOFI PASTEUR~U2806AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327545	10/08/2008	TX	12.0	12		F	10/08/2008	Patient received Flu vaccine in left deltoid, marked swelling and erythema, tenderness. Swelling about 3cm diameter. Twenty-four hours later with sore throat, burning sensation, felt like airway narrowing. Appeared to inflame the patient's Gastroesophageal Reflux Disease which had been dormant for 6 months. 12/15/08-records received for DOS 10/1-10/2-10/2/08-presented to ED with serum reaction. C/O dysnpnea, rash, swelling of throat. Assessment:acute allergic reaction.  Rhinorrhea.				Y					Y	09/30/2008	09/30/2008	0	ESR elevated at 59, CRP=0.7, WBC=6.3, had urticaria. 12/15/08-records received-EKG: prolonged QT. CXR: normal.	UNK	UNK			Multiple Drug Allergies, Red Dye 40, GERD			1						1	Burning sensation; C-reactive protein normal; Condition aggravated; Erythema; Pharyngolaryngeal pain; Red blood cell sedimentation rate increased; Swelling; Tenderness; Throat tightness; Urticaria; White blood cell count normal	FLU3~SANOFI PASTEUR~U2759AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0327549	10/08/2008	AZ	62.0	62		F	10/08/2008	Severe myalgias. Low grade fevers				Y					U	10/06/2008	10/06/2008	0	Lumbar MRI negative. Lab tests normal.	PVT	PVT						1						1	Laboratory test normal; Myalgia; Nuclear magnetic resonance imaging normal; Pyrexia	FLU3~SANOFI PASTEUR~U2740AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0327553	10/08/2008	CA	14.0	13		F	10/05/2008	SYNCOPE WITH BRIEF 5  SEC. SEIZURE									Y	10/05/2008	10/05/2008	0	PULSE OX 99% EKG NORMAL	UNK	UNK		NO	NO			1						1	Convulsion; Electrocardiogram normal; Oxygen saturation normal; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88636~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HPV4~MERCK & CO. INC.~0572X~2~IM~RA~HPV (GARDASIL)~1	USA		Influenza
0327554	10/08/2008	UT	75.0	75		F	10/08/2008	Redness in left deltoid, area swollen approximately 6 in diameter.									U	10/07/2008	10/08/2008	1	na	UNK	PVT	Warfarin, Ramipril, Celebrex	none	NKA			1						1	Erythema; Swelling	FLU3~SANOFI PASTEUR~U2802AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0061U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327559	10/08/2008	NV	26.0	26		F	10/08/2008	PATIENT WAS GIVEN THE FLUMIST VACCINE WHILE PREGNANT									Y	10/03/2008			NONE	UNK	MIL						1						1	Drug exposure during pregnancy	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0327560	10/08/2008	SC	25.0	25		M	10/08/2008	10/06/08  Patient states within one hour of vaccination, broke out in hives (less than or equal to 30) over arms, face.  Took 25 mg Benadryl and hives decreased, but then reappeared 30 minutes later.  Took 25 mg Benadryl again and hives resolved									Y	10/03/2008	10/03/2008	0	none	PUB	PUB	none	none	Ceclor, Amoxicillin		SC0811	1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0327561	10/08/2008	TX	91.0	91		F	10/08/2008	PATIENT CAME IN WITH COMPLAINTS OF ITCHING AROUND THE NECK AND UPPER CHEST AREA.  SHE HAD SMALL BUMPS RESEMBELING HIVES AND SCRATCH MARKS AS IF SHE'D BEEN SCRATCHING.									U	10/01/2008	10/07/2008	6		UNK	PUB						1						1	Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88626~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0327562	10/08/2008	IL	56.0	56		M	10/08/2008	Lightheadedness and headache									Y	10/08/2008	10/08/2008	0	None	UNK	PVT	Avapro, Imdur, Januvia, Metformin, Byetta, Lasix, KCL, Prevacid, ASA, Toprol XL, Pravastatin, Tricor, Omega 3, Centrum Silver, Co-Q 10	None	None			1						1	Dizziness; Headache	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0327563	10/08/2008	NJ	4.0	4		F	10/08/2008	Left upper arm induration, warmth and tenderness, starting within first 24 hours after vaccine administration, worsening at 48 hours.  Treatment with cool compresses, motrin. Benadryl given by mother without improvement.									U	10/06/2008	10/07/2008	1	None performed	UNK	UNK	none	none	none			1						1	Injection site induration; Injection site pain; Injection site warmth	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B103AB~1~IM~LA~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~UT2791AA~3~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327564	10/08/2008	OH	84.0	84		M	10/08/2008	Pt contacted facility with complaint of mild vertigo and chest heaviness approximately 2 hours after vaccination.									Y	10/08/2008	10/08/2008	0	none	UNK	PVT						1						1	Chest discomfort; Vertigo	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0327565	10/08/2008	WA	35.0	35		F	10/08/2008	itchiness/redness/heat at site of injection  Benadryl 25mg po given     Heatredness remains, itchiness resolved post one hour									Y	10/08/2008	10/08/2008	0		PVT	PVT		none	none		flulaval	1						1	Injection site erythema; Injection site pruritus; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflla172aa~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0327567	10/08/2008	NC	11.0	12		F	10/08/2008	Syncopal Episode in the doctor's office, while standing, caught by nurse and myselfe(mother), accompanied by seizure activity.  We lifted her on the exam table and she came to after about one minute.  As a mother, I am very concerned after reading all of the internet reports of adverse effects.  I will not complete the next two treatments.									U	10/08/2008	10/08/2008	0		PVT	PVT		None	None			1						1	Convulsion; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~UNK~~~MENINGOCOCCAL (NO BRAND NAME)~1	USA		Influenza
0327568	10/08/2008	OR	39.0	39		F	10/08/2008	Patient c/o headache, fever up to 102.7 and left shoulder pain.  Small bruise at center of left shoulder.  Patient received both flu shot and Pneumovax at 9 a.m. 10/2/08 in the left deltoid.  Patient reported that several hours later she started developing symptoms (HA, fever, shoulder pain).  She presented to the immediate care the following day.  Beyond ANSAIDS and ice/heat, the MD ordered her to follow up in 2-3 days unless completely better.  There has been no follow up from patient.									Y	10/02/2008	10/03/2008	1	n/a	PVT	PVT	Xanax, Divan	none	lisopril, vicodin			1						1	Contusion; Headache; Musculoskeletal pain; Pyrexia	FLU3~SANOFI PASTEUR~U2752AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0519X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327569	10/08/2008	CA	41.0	41		M	10/08/2008	Patient developed swelling of lips and itching of eyes.  Allergic reaction.									N	10/07/2008	10/08/2008	1		PUB	UNK		NONE	NONE			1						1	Eye pruritus; Hypersensitivity; Lip swelling	FLU3~SANOFI PASTEUR~U2757AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327579	10/08/2008	AK	45.0	45		F	10/08/2008	4 inch red area that itched for 2 days.  MD gave patient Benadryl and it has resolved.									Y	10/04/2008	10/04/2008	0		OTH	PVT						1						1	Erythema; Pruritus	FLU3~SANOFI PASTEUR~U2742AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327580	10/08/2008	AK	56.0	56		M	10/08/2008	Patient had pain/tenderness in right arm and red streaks on chest.  ER doctor gave patient IV Abx, Zantac, Cephalerin, sm x 1 tmp and hydroxreine.  Patient states 10/8/08 he has improved.				Y					Y	10/04/2008	10/04/2008	0	Infection	OTH	PVT		None				1						1	Erythema; Infection; Pain in extremity; Skin striae; Tenderness	FLU3~SANOFI PASTEUR~U2742AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1005F~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0327581	10/08/2008	WA	69.0			F	10/08/2008	After a few days the skin turned red, hot, sore and had a hard spot.									Y				None	OTH	UNK		None	No			1						1	Erythema; Induration; Pain; Skin warm	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0988F~UNK~SC~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327582	10/08/2008	WA	59.0	59		F	10/08/2008	Flushing, tingling of hands, gum, tongue, fainting.  She took a Benadryl on her arm.  She got a flu shot yearly but has never received a pneumo shot.  Onset happened within 5 minutes of pneumo shot.									Y	10/08/2008	10/08/2008	0		OTH	PVT		None	PCN			1						1	Flushing; Paraesthesia; Paraesthesia oral; Syncope	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA183AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0200U~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327585	10/08/2008	CO	62.0	62		M	10/08/2008	Had injection at 5:30-6:00pm.  Went to dinner at restaurant.  Had 1 glass of wine, ate dinner and had 1 more glass of wine.  Felt sick during dinner and this continued through the night and all of Friday.  Symptoms were exhausted, dizzy.  Slept all Friday, missed work.  Felt better Saturday afternoon.									Y	10/02/2008	10/02/2008	0		OTH	PVT		Short-term				1						1	Activities of daily living impaired; Dizziness; Fatigue; Hypersomnia; Malaise	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89971~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330006	10/08/2008	OH	5.0	5		F	10/02/2008	Henoch-Schonlein Purpura developed one days after Flu vaccine we purpura lesions especially on lower abdomen, lower extremities with swelling of feet. Labs done at ER-hospital, on 10/1/08.  Rx ibuprofen when seen on 10/7/08 & Rx ZITHROMAX.				Y					N	09/29/2008	09/30/2008	1	10/1/08-Na-140, K-4.6, CK-100, CO2-28, BUN-9; Cr 0.5, CBC-WBC-9.200, (60-S, 33-L, 3-M, 4-E) H&H 15.6/43.7, plat 279,000, U/A - neg blood & protein	PVT	PVT		None	Amoxicillin Allergy-10/13/07			1						2	Blood urine absent; Dehydration; Diet refusal; Henoch-Schonlein purpura; Joint swelling; Laboratory test normal; Oedema peripheral; Pain in extremity; Rash pruritic; Vasculitis; Vomiting; Blood creatine phosphokinase normal; Blood creatinine normal; Blood potassium normal; Blood sodium normal; Blood urea normal; Carbon dioxide normal; Eosinophil percentage; Full blood count; Haematocrit increased; Haemoglobin increased; Henoch-Schonlein purpura; Lymphocyte percentage; Monocyte percentage; Neutrophil percentage; Oedema peripheral; Platelet count normal; Urine analysis normal; White blood cell count normal	FLU3~SANOFI PASTEUR~U2763AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2763AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0327571	10/09/2008	TN	43.0	43		M	10/09/2008	PT REPORTED ON 10/5/08 THAT HE EXPERIENCED SWELLING, ITCHING, REDNESS, AND PAIN IN THE LEFT ARM ON THE DAY AFTER RECEIVING PNEUMOVAX.  HE WENT IN TO MEDICAL CENTER 10/4/08 AND WAS GIVEN RX'S FOR METHYLPREDNISOLONE, TRAMADOL/APAP, AND CLARITHROMYCIN.  ALSO WAS INSTRUCTED TO USE ICE ON ARM EVERY 20 MINUTES. ON 10/6/08 PT REPORTED HIS ARM STILL HAD SOME REDNESS AND ITCHING, BUT THE SWELLING HAD GONE DOWN AND WAS MUCH BETTER.				Y					U	10/03/2008	10/04/2008	1		UNK	UNK		NONE KNOWN	NONE KNOWN			1						1	Erythema; Oedema peripheral; Pain in extremity; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0554U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0327572	10/09/2008	TN	71.0	71		F	10/09/2008	PT REPORTED ON 10/4/08 THAT HER UPPER ARM WAS SIGNIFICANTLY SWOLLEN TO THE ELBOW.  IT WAS ALSO VERY RED AND ITCHED. PT USED ICE ON THE ARM BUT DID NOT SEEK MEDICAL ATTENTION. ON 10/6/08 PT REPORTED THAT THE REDNESS WAS GONE. SHE WAS STILL EXPERIENCING SOME ITCHING, AND HAD SOME SWELLING IN THE UPPER ARM NEAR THE ELBOW.									U	10/03/2008	10/03/2008	0		UNK	UNK	UNKNOWN	NONE KNOWN	NONE KNOWN			1						1	Erythema; Oedema peripheral; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0554U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327657	10/09/2008	MI	59.0	59		U	10/09/2008	Severe Headache, tightening of throat and chest tingling in arm, muscle spasms, nausea, soreness in joints, blurred vision start 10:30P 10/8/08 subsided some by 1:30P 10/9/08. Headache and tight chest still ongoing.									U	10/08/2008	10/08/2008	0	None	UNK	UNK						1						1	Arthralgia; Chest discomfort; Headache; Muscle spasms; Nausea; Paraesthesia; Throat tightness; Vision blurred	FLU3~CSL LIMITED~02349111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0327658	10/09/2008	MA	41.0	41		F	10/08/2008	Cough, feeling lightheaded. Monitored virtual signs, no other treatment. Employee went home for the day.									Y	10/08/2008	10/08/2008	0		PVT	UNK		None	None			1						1	Activities of daily living impaired; Cough; Dizziness	FLUX~UNKNOWN MANUFACTURER~U27B5CA~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0327660	10/09/2008	FL	67.0	67		F	10/07/2008	Sharp pain or knot in left arm, fever since I got the flu shot. Told Doctor about it and my husband. Still pain									N	10/05/2008				PUB	UNK		None	None	pain in arm and knot in arm - still~Influenza (Seasonal) (no brand name)~1~0.00~In Patient		1						1	Pain in extremity; Pyrexia; Skin nodule	FLU3~CSL LIMITED~AFLUA302AA~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0327663	10/09/2008	WV	6.0	6		F	10/03/2008	Pt presented 5 wks later complaining of pain at injection site. rec MOTRIN +/- x ray				Y					U	08/22/2008	08/22/2008	0	x ray on upper leg	PVT	PVT	None	None	None			1						1	Injection site pain; X-ray	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~32971919~UNK~UN~RL~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~0315X~2~UN~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0327666	10/09/2008	PA	16.0	16		M	10/07/2008	Fever 102 within 24 hrs of vaccine shot seizure <5 min with no need for intervention.									Y	10/04/2008	10/05/2008	1		PVT	PVT	RISPERDAL; REMERON; ZOLOFT; CARBATROL; NEURONTIN; DIASTAT; PERRICTUM PRN; LASIX; PREVACID; NOVASOURCE FORMULA; SILVADENE CREAM TO G-tube site / prn;SINGULAIR; NASONEX; ALLEGRA; ADVAIR; FLOVENT; XOPENEX; RIOMET; SYNTHROID; DIFFERIN CREAM BID	URI Symptoms	Questioning Cornelia DeLange syndrome, ? Miles-Carpenter syndrome or Renpenning syndrome (waiting on mom's x-chromosome studies- to send specific testing for PQBP1gene (9/08) DiGeorge syndrome; Specific antibody defect deficiency normal response to protein antigens (tetanus) home IG therapy; a 2 week sub injections; Mental retardation and behavior problems Perseverative and oppositional; Seizure disorder - (summer 08); Headaches (MRI head negative 2/06); Type 2 diabetes - Endocrine; Hypothyroidism - (low free T4 10/4 endocrine, started on synthroid 2/06); TOF s/p repair - repaired 4/92; B/L Pulmonary Angioplasty 1/93; Mod - severe pulmonary valve insufficiency Right heart volume overload - will eventually need valve replacement 2/08 (lasix) Follows peds cardiology, for 6 months, will need MRI in summer '08; Murmurs - 2/6 SEM, 2/4 Diastolic decrescendo murmur LSB; GERD (S/P Nissen Fundoplication with Gtube placement 7/92) Following Dr.; Chronic sinusitis (Apr 07), Mild intermittent asthma followed Dr. Allergic Rhinitis; Submucous cleft' evaluated in early infancy at by Dr; recurrent otitis media in infance; bilateral myringotomy with tubes times 3 in infancy; borderline sensory Neural hearing loss. Hearing aids not recommended at this time but needs annual audiology checkup. Followed by Pediatric ENT.; Hyperopia spectacle correction. Followed by Eye Physicians, Dr. (12/08 next); Thoracic kyphosis - 52 degrees, brace 8 hrs/day, PT with ortho following for 5 months; coccydynia 4/08= motrin; Fracture and misaligned coccyx 9/08: observation; Mild macrocytosis - followed by Dr., no further w/up nec 1/06; Dermatology: Acne Vulgaris; Pneumonia hosp, 3/7/05-3/10/05, 1/08; UTI, hosp 3/05; Pneumonia viral (winter '05); Bacterial RLL 12/03; Hosp 8/06 Mono/Pneumonia			1						1	Convulsion; Pyrexia	FLU3~SANOFI PASTEUR~U2765AA~7+~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2865AA~6~IM~UN~TDAP (ADACEL)~1	USA		Influenza
0327667	10/09/2008	IL	66.0	66		F	10/05/2008	Patient's left arm began to hurt at about 12:30PM and by 4PM the same day, her arm was swelling about 4 inches around the site of injection. Her arm was also starting to feel numb. The pharmacy advised her to put ice on the swelling and take benadryl. By Thursday morning, her arm was still swollen so she called her doctor and she was advised to take Benadryl and Zyrtec. By Friday, patient was feeling much better & the swelling had gone down.									Y	10/01/2008	10/01/2008	0		OTH	PUB	Unknown					1						1	Hypoaesthesia; Injection site swelling; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0551X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327668	10/09/2008	TN	38.0	38		M	10/06/2008	Local, redness, erythema, whelps. Systemic: fever, myalgia.				Y					U	10/03/2008	10/03/2008	0		OTH	OTH	AUGMENTIN	As above	NKDA			1						1	Erythema; Local reaction; Myalgia; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~0233X~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~U2767AA~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0327670	10/09/2008	PA	54.0	54		F	10/03/2008	Severe redness, warmth, itching swelling (R) upper arm shoulder and lymphadenopathy (R) supraclavicular and (R) axillary within 24-48 hours of vaccination. No SOB.									U	10/01/2008	10/02/2008	1	None	PVT	PVT	LANTUS; HUMALOG; CRESTOR; DARVOCET	DM; hypothyroidism; hx breast CA; hyperlipidemia				1						1	Erythema; Lymphadenopathy; Oedema peripheral; Pruritus; Skin warm	FLU3~SANOFI PASTEUR~U2763AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0047X~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327671	10/09/2008	TN	49.0	49		M	10/03/2008	9/18 Next morning lg whelp under right arm by afternoon developed 2 cm whelps inside left bicep itching and reddened, persisted for 5 days used OTC CORTAID ointment for itching.									Y	09/18/2008	09/19/2008	1		PVT	PVT	OTC CORTAID ointment		Allergic, to TETRACYCLINE only			1						1	Erythema; Pruritus; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500544~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0327674	10/09/2008	ID	34.0	34		M	10/03/2008	See attached description of events. Client states he has allergies and has had ear infection in the past. Monday, I felt a little tired that morning but nothing substantial. Received the vaccine around noon. The rest of the day was the same, just tired. Medication, none. Tuesday, Woke up with a pounding headache above my right eye, felt tired and weak throughout the day, acquired a sore throat about 1:00. Medication, Ibuprofen about 500mg. Wednesday, Woke up with a slight headache above my right eye, felt very dizzy, had watery eyes, clear drainage from the nose, throat felt better but had a dry cough. Went home at 10:00 sick. Medication, Ibuprofen about 1000mg. Thursday, Woke up with a headache more isolated to the back of the head, felt less dizzy than Wednesday but still dizzy, drainage's had diminished and dry cough was almost gone. Medication, Ibuprofen about 500mg up until sending this e-mail. Will take about 500mgs more before the days end. Main concern at this point is getting rid of the headache and dizziness.									Y	09/29/2008	09/30/2008	1		MIL	UNK		Client states he had felt funky Slightly tart in morning but didn't think much of it.			IP08040	1						1	Activities of daily living impaired; Asthenia; Condition aggravated; Cough; Dizziness; Fatigue; Headache; Lacrimation increased; Oropharyngeal pain; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~5005590~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0327837	10/09/2008	OH	62.0	62		M	10/09/2008	3 to 4 hours after shot   started a fever I couldn't get warm   few hours later my fever rose and the rest of me was freezing this lasted the rest of the night until 6 am    fever is gone now  but i feel weak   never had this happen to me before									Y	10/08/2008	10/08/2008	0		UNK	PVT						1						1	Asthenia; Feeling cold; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0327838	10/09/2008	MA	51.0	51		F	10/09/2008	Patient was administered flu vaccination on 10/7/08 as well as pneumovax.  Flu shot was given in L arm, Pneumovax in the R arm at approximately 2PM.  Later that evening, the patient noted significant swelling and redness about her R upper arm, without accompanying fever or chills.  She sought care in the ER and was given a prescription for keflex for cellulitis and prednisone x 4 days.  Followup visit in the office with me on 10/8/08 showed improvement in redness, still with significant swelling, distal R extremity was neurovascularly intact.  No sign of lymphangitis.  I advised the patient to fill her prescription for keflex and prednisone, and to call if worsening signs or symptoms.				Y					U	10/07/2008	10/07/2008	0	none	PVT	UNK	ibuprofen	None	latex-eczema, asthma			1						1	Cellulitis; Injection site erythema; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLL169AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~05554~2~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0327839	10/09/2008	NY	34.0	34		F	10/09/2008	Fever of 99.9 - 102.5 for 36 hours +. Aches, pains, dizziness, extreme fatigue, dehydration (flu-like symptoms)									Y	10/07/2008	10/07/2008	0		UNK	PVT						1						1	Dehydration; Dizziness; Fatigue; Influenza like illness; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~AFLLA156AA~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0327841	10/09/2008	OH	5.0	5		M	10/09/2008	15 X 6 cm erythema, treated with cool compress, monitor for progression				Y					Y	10/07/2008	10/08/2008	1	none	PVT	PVT	none	no	atopic dermatitis, seasonal allergy			1						1	Erythema	FLU3~SANOFI PASTEUR~U2764AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0327842	10/09/2008	CA	2.0	2	.8	M	10/09/2008	Pt had a febrile seizure 5 days after vaccination; temp was measured at 103 in ER; pt does have a history of febrile and afebrile seizures prior				Y					Y	09/30/2008	10/06/2008	6		PVT	UNK	amoxicillin	mild cough	speech delay; h/o seizures, last 12/07			1						1	Body temperature increased; Condition aggravated; Febrile convulsion	FLU3~SANOFI PASTEUR~U2782C~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0327845	10/09/2008	WA	53.0	52		F	10/09/2008	nausea, headache, malaise             missed two days of work									Y	10/06/2008	10/06/2008	0		PVT	PVT		none				1						1	Activities of daily living impaired; Headache; Malaise; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflla172aa~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0327846	10/09/2008	TX	55.0	55		F	10/09/2008	Shot administered 12:45PM 10/8/08.  Awoke at 5AM 10/9/08 feeling dizzy and feverish.  Headache and joint aches about 8AM. A coworker that received vaccine at same time did not experience any ill effects.									Y	10/08/2008	10/09/2008	1	Visit#2686466	UNK	PVT	Vivelle dot 0.075mg	none	codeine & mustard allergy			1						1	Arthralgia; Dizziness; Headache; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA176AA~2~UN~~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0327847	10/09/2008	KY	54.0	54		F	10/09/2008	PATIENT RECEIVED VACCINE 10-8-08 , SHE CALLED THE PHARMACY ON 10-9-08 TO TELL ME HER ARM WAS HURTING  , RED AND SWOLLEN . I SPOKE WITH HER PERSONALLY TO SEE IF IT WAS ONLY RED AT THE INJECTION SITE SHE SAID IT WAS RED THERE FIRST , BUT NOW HER WHOLE ARM IS RED AND SWOLLEN. I TOLD HER TO PUT ICE ON HER ARM AND CALL HER DR ABOUT COMING IN THE LOOK AT HER ARM.				Y					N	10/08/2008	10/08/2008	0		UNK	PUB		BREAST CANCER SURVIVOR				1						1	Erythema; Oedema peripheral; Pain in extremity	FLU3~CSL LIMITED~02349111A~2~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~0958F~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0327848	10/09/2008	RI	58.0	58		M	10/09/2008	48 hours after injection the employee stated his lower right side of lip was swollen and right side of lower face felt numb - employee is unsure if he had a little pimple on his lip when this event started - given benadryl and bactrim									U	10/06/2008	10/08/2008	2		UNK	PUB						1						1	Hypoaesthesia facial; Lip swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA156AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0327850	10/09/2008	TX	34.0	34		F	10/09/2008	Pt is a female teacher who received FluMist through our school-based influenza vaccination program on October 2, 2008. Within an hour of receiving FluMist, pt complained that her tongue was getting numb and swollen, and she was becoming itchy and splotchy. She was treated at the school with Benadryl 25 mg by mouth but refused additional Benadryl or Epipen. EMS arrived at the school and administered intravenously 25 mg of Benadryl. She was subsequently taken to emergency department and by the time she arrived she was feeling better. She never experienced hypotension, wheezes, stridor, or respiratory distress. Pt was not hospitalized and discharged home on Benadryl 25 mg by mouth every 6 hours until midnight.   Past Medical History: Nasal allergies Medication: Wellbutrin SR, Allegra D, Nasacort spray and birth control pill.   Influenza vaccine: FluMist Date of Vaccination: 02 Oct 2008 Date of Birth: 02 Aug 1974 Date of SAE: 02 Oct 2008 SAE:   Event was related to FluMist and serious				Y					Y	10/02/2008	10/02/2008	0	Physical examination	UNK	UNK	Allegra D, Nasacort spray, Wellbutrin, birth control pill	Allergic rhinitis	Ragweed allergy			1						1	Hypoaesthesia oral; Pruritus; Rash macular; Swollen tongue; Hypoaesthesia oral; Pruritus; Rash macular; Swollen tongue	FLUN3~MEDIMMUNE VACCINES, INC.~500556P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500556P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Emergency room visit	Influenza
0327851	10/09/2008	KY	67.0	67		F	10/09/2008	PATIENT IS EXPERIENCING PAIN, SWELLING, REDNESS AND ITCHING OF THE RIGHT ARM BETWEEN THE ELBOW AND SHOULDER.  SYMPTOMS ARE PREVALENT ON THE UNDERSIDE OF THE ARM (FATTY AREA OF TRICEP) AND DELTOID. PATIENT ALSO COMPLAINS OF SLIGHT FEVER ON 10/9/08.  PT WAS GIVEN 50 MG OF DIPHENHYDRAMINE ELIXIR AROUND 3:00 PM ON 10/8/08 AND ADVISED TO USE COLD COMPRESS ON AREA. PT DID NOT WANT TO TAKE DIPHENHYDRAMINE EARLIER WHILE WORKING.									N	10/07/2008	10/07/2008	0		UNK	UNK	UNKNOWN	NONE	NONE UNKNOWN			1						1	Injection site erythema; Injection site pain; Injection site pruritus; Injection site swelling; Pyrexia	FLU3~CSL LIMITED~02349111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~0554U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327853	10/09/2008	GA	55.0	55		F	10/09/2008	INJECTION SITE LOCAL REACTION---SWOLLEN, RED, HOT TO TOUCH---TYLENOL AND MOTRIN AT HOME									U	10/08/2008	10/08/2008	0		PUB	UNK		NONE	NONE			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Local reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA375AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0327854	10/09/2008	CO	73.0	73		F	10/09/2008	Patient called 1 hour after receiving the shot reporting pain,bruising and hard knot formed at injection site. Recommend cold compress and analgesic. If symptoms worsen, call the doctor and follow up. Followed up with patient 3 hours later, she was doing better. Informed patient to follow up with the doctor if symptoms don't resolve.									U	10/07/2008	10/07/2008	0		UNK	PUB		N/A	n/a			1						1	Injection site bruising; Injection site induration; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89971~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0327855	10/09/2008	GA	39.0	39		F	10/09/2008	INFECTION SITE--RED SWOLLEN									Y	10/07/2008	10/07/2008	0		PUB	UNK						1						1	Injection site erythema; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA375AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0327856	10/09/2008	TX	38.0	38		F	10/09/2008	Pt has a 60 x 90mm red warm knot on her left deltoid.  She doesn't have any pain or discomfort.									U	10/07/2008	10/08/2008	1		PVT	PVT			Sudafed allergy    Asthma			1						1	Injection site erythema; Injection site induration; Injection site warmth	FLU3~SANOFI PASTEUR~U2806AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327857	10/09/2008	TX	18.0	18		F	10/09/2008	Wheezing, runny nose, coughing, asthma.  Treated with Albuterol through nebulizer.									U	10/01/2008	10/05/2008	4	None	PVT	PVT		None	Asthma			1						1	Asthma; Condition aggravated; Cough; Rhinorrhoea; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0327858	10/09/2008	TX	9.0	9		M	10/09/2008	Nausea and vomiting, diarrhea									U	10/01/2008	10/05/2008	4		PVT	PVT		None				1						1	Diarrhoea; Nausea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0327859	10/09/2008	MN	67.0	67		F	10/09/2008	Patient received vaccine on 10-6-08 at about 11:30am. Later in the evening hives developed all over her body. She called the pharmacy on Wednesday, at that time the hives were still present, but were not as severe as on Tuesday. She came into the pharmacy on Thursday morning (10-9-08) to show us her hives and ask about management and how long the reaction could last.									N	10/06/2008	10/06/2008	0	None	UNK	PVT	Allegra	Seasonal allergies	Patient currently taking Allegra, has history of severe allergies, reports that fall is the worst time of the year.			1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89880~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0327861	10/09/2008	TX	86.0	86		M	10/09/2008	significant erythema, warmth, swelling at injection site upon examination; Pt received injection on a Friday afternoon 9/26/08. He called in on Monday morning 9/29/08 complaining that his arm was still hot and red and was advised to come in to the clinic. Pt was examined and given an injection of triamcinolone 60mg IM with further instructions to return if his symptoms did not resolve. As of this date he has not returned for further treatment.				Y					Y	09/26/2008	09/27/2008	1		UNK	UNK	ALENDRONATE, ASA, CLOBETASOL 0.05%CRM, EZETIMIBE, FERROUS SULFATE, GUAIFENESIN/DM SYRUP, LEVOTHYROXINE, MOXIFLOXACIN OPHTH SOLN, PANTOPRAZOLE, PHENYLEPHRINE OPHTH SOLN, ROSUVASTATIN, MULTIVITAMIN, TRIAMCINOLONE O.1% OINT, TROPICAMIDE 1% OPH	NONE	Allergies: Horse Serum,Tetanus Toxoid  Medical Conditions: CAD w/hx MI, Carotid stenosis, hyperlipidemia, GERD, cataracts, hx prostate CA, MDS, squamous cell CA, acquired hypothyroidism, lumbar radiculopathy	~Tetanus Toxoid (no brand name)~~0.00~Patient		1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA181AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0224x~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0327862	10/09/2008	AZ	60.0	60		F	10/09/2008	Pt c\o pain and edema to right deltoid starting in PM of 9/18/08. Was vaccinated with influenza to right deltoid IM on 9/16/08. Area of edema and erythema less than 1 cm to right deltoid found on exam. Pt prescribed Keflex 500mg BID for 10 days. May take loratadine or benadryl OTC prn itching qd. Apply ice packs prn. Motrin 600mg tid prn pain q 6 hrs.				Y					U	09/16/2008	09/19/2008	3	None	PUB	PVT	CRESTOR,VESICARE,LEVOTHYROXINE,TOPROL XL,ACTONEL,PAXIL CR,ASA,FOLIC ACID,CALCIUM AND VICODIN.	HTN,hypothyroid,osteoporosis,hypercholesterolemia,chronic low back pain,and overactive bladder.	PCN, SULFA, NOVOCAINE	NONE~ ()~NULL~~In Patient|UNKNOWN~ ()~NULL~~In Sibling1|UNKNOWN~ ()~NULL~~In Sibling2		1						1	Erythema; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2749AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0327863	10/09/2008	TX	74.0	74		M	10/09/2008	Noticed discomfort that didn't resolve by bedtime of 10/8/08. Redness and swelling of upper arm, hot to touch. No self treatment as of today. Area is expanding and is uncomfortable. Referred to Dr today.				Y					U	10/07/2008	10/08/2008	1	unk	UNK	UNK	Levothyroxine, lovastin, lisinopril, doxepin, paxil	none	Sulfa			1						1	Discomfort; Erythema; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U2807AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0244X~UNK~SC~~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0327864	10/09/2008	TX	45.0	45		M	10/09/2008	SOFT TISSUE UNDER TONGUE STARTED SWELLING.  EYE LIDS SWELLED, COUGHING, DIFFICULTY BREATHING.  EVENT OCCURRED APPROXIMATELY 2 1/2 HOURS AFTER ADMINISTRATION OF VACCINE.  BENADRYL/ZANTAC GIVEN WHICH REVERSED REACTION.  HAD TO BE REPEATED 4 HOURS LATER WHEN SYMPTOMS RESUMED.  NO EPINEPHRINE HAD TO BE ADMINISTERED. 10/20/08 Per hospital RN, pt was not treated at facility. Was administered Epipen at home by spouse who is an RN.			Y						Y	10/07/2008	10/07/2008	0		UNK	UNK						1						1	Cough; Dyspnoea; Eyelid oedema; Oedema mouth	FLU3~SANOFI PASTEUR~U2763AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0327865	10/09/2008	FL	63.0	63		M	10/09/2008	I administered Flulaval IM at 11:30 AM to pt. in his left Deltoid. At 11:35 the pt., who was seated, c/o feeling weak and placed his head between his legs. He became unresponsive, and I leaned him back in the chair to prevent him from falling. His back began to arch, his eyes were open and glassy, and respirations became slow and shallow. He did not respond to voice or painful stimuli. His skin was pale and clammy when I was checking for a pulse. He appeared to be having a seizure until his face became very red and respirations ceased. I could not detect a pulse and there were no respirations. Other female staff assisted me in lowering him to the floor to start CPR. We put him down hard in our haste, and he began breathing again. At this point, his color was pasty gray and he was extremely diaporetic. 911 was called, and by the time the paramedics arrived at approximately 11:48 AM, the pt. was able to respond to their questions. He was very weak and tremorous and had been incontinent of urine. He was transported to the ER for further evaluation.				Y					Y	10/08/2008	10/08/2008	0	unknown	UNK	PVT	unknown	none apparent	coronary artery stents, pt. reported previous episode some years ago of severe vasal/vagal response			1						1	Asthenia; Cold sweat; Erythema; Hyperhidrosis; Hypoventilation; Opisthotonus; Pallor; Pulse absent; Respiratory rate decreased; Tremor; Unresponsive to stimuli; Urinary incontinence	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA172AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0327866	10/09/2008	OK	72.0	72		F	10/09/2008	Developed chills, muscle aches and high fever (102.6).  Improvement noted approximatelt 12 hours after onset.									Y	10/08/2008	10/09/2008	1		PUB	PUB						1						1	Chills; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~AFLLA175AA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0327867	10/09/2008	OK	55.0	55		F	10/09/2008	Large 15cm x 17cm local painful whelp on the site of injection on the left arm				Y					U	10/08/2008	10/08/2008	0		PVT	PVT	Prozac, Premarin, Tranxene, Valium, Advair, Albuterol	None	Hypercholesterolemia, post-menopausal vasomotor symptoms, anxiety, allergic rhinitis, asthma			1						1	Injection site pain; Injection site urticaria; Local reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89750~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0224x~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0327868	10/09/2008	TX	48.0	48		F	10/09/2008	After i received flu shot I had a bad headache.On 10-8-08  I woke up with chills and dizzines I called my doctors office  that morning I told the assisant my symptoms, and that I had a flu shot on 10-7-08. Nurse returned my call.I asked if it was okay to take some meclizine she asked what amount I  told her . I had some relief, the next morning 10-9-08 .I woke with the same sympotoms.									Y	10/07/2008	10/08/2008	1	cbc& protime	UNK	UNK		myasthemia gravis,chronic myopathy,neuropathy, and sarcosodis	contrast dye, listed in #18			1						1	Chills; Dizziness; Full blood count; Headache; Prothrombin time	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0327869	10/09/2008	GA	47.0	47		F	10/09/2008	Shot was administered at appx. 3:30 pm and about 15 mins. after I was nauseated, throwing up, hives, weak and dizzy.  Later that evening, I was horse and rapid heart rate.  My throat started swelling and the EMTs were called after 10:00 pm and I was transported to Medical Center.  I was seen by Dr.  I was given an IV of steroids, Benedryl drew blood and was told that I had a bad reaction to the flu shot.  I am still taking steroids, Methyiprednisolone and Hydroxyzpam.				Y					N	10/04/2008	10/04/2008	0	Was told that I had a bad reaction to the flu shot.	UNK	UNK						1						1	Asthenia; Dizziness; Dysphonia; Heart rate increased; Nausea; Pharyngeal oedema; Urticaria; Vaccination complication; Vomiting	FLU3~SANOFI PASTEUR~U2768AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0327871	10/09/2008	NE	70.0	70		M	10/09/2008	Vaccine given left arm 10/6/08. 10/7/08 in afternoon started with nausea and hives over most of body. vomited x 2. Nausea resolved by 10/8/08 and hives persist upon my exam this PM (10/9/0) Hives on exam predominately upper body left arm worse than right. After detailed history could not find any other known triggers. No fever or other systemic symptoms.									U	10/06/2008	10/07/2008	1	none	PUB	UNK	ASA, metoprolol, lisinopril, caduet, metoclopramide prn (not taken)	Rare cough due to mild viral illness that started 3 weeks prior. Almost completely resolved per pt.	Hypertension, dyslipidemia,coronary artery disease			1						1	Nausea; Urticaria; Vomiting	FLU3~SANOFI PASTEUR~U2805AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327874	10/09/2008	IN	59.0	60		M	10/09/2008	I played gold two (2) hours after getting my flu vaccine injection.  Injection given at 10AM, 10/07/2008.  About eight (8) hours after the vaccination I started to get a headace, felt very cold (like I was coming down with a cold), even to the point I was shivering and my teeth were chatering.  I took two Aleve and went to bed with an extra blanket on at about 9:00PM.  At about 3:30AM my fever broke (woke up sweating profusely).  At 6:00AM day after injection I felt fine.  I have felt OK since.    I know this vaccine is a dead virus and will not give you the flu.  But when talking with the Nurse Practionner, she felt we should report this, as it may be a side effect not listed.									Y	10/07/2008	10/07/2008	0	N/A	UNK	UNK	CLARITIN (non-drowsy 24-hour pill)(active ingredient - Loratadine 10mg) //  CENTRUM Multivitamin/Multimineral Supplement	NONE	NONE	N/A~ ()~NULL~~In Patient		1						1	Chills; Feeling cold; Headache; Hyperhidrosis; Pyrexia	FLU3~SANOFI PASTEUR~UNKNOWN~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327875	10/09/2008	UT	31.0	31		M	10/09/2008	Ascending weakness in legs and arms - diagnosed as GBS. Treated with IVIG 2 gm/kg (175 gm) given over 3 days (9/30 to 10/2) and IVIG 1 gm/kg (90 gm) given over 2 days (10/4 to 10/5). 10/27/08-records received for DOS 9/29-10/8/08-DC DX: GBS. Presented to ED with 2 day history of worsening ascending lower and upper extremity weakness with abnormal sensation. Tightness and tingling of fingertip, elbow and knee. Unable to rise from squat. Episode of a fall. PE: ascending stocking glove neuropathy with weakness and decreased vibratory sensation in hands and feet. Swallowing difficulties. Treated with IVIG. 1/28/2010 Last seen in clinc 3/5/09. At that time continued to report fatigue, fine moto deficits, numbness in feet.  On exam found to have reduced reflexes and sensations. Expected to continue improvement over the next 12 months with likely no residual deficits.			Y		Y	10			N	09/18/2008	09/27/2008	9	9/30: EMG - supportive of primary demyelination consistent with GBS. 9/29: CSF - RBC=127; WBC=2; protein=42; glucose=51. 10/27/08-records received-Monocytes % increased 14.3, phosphorous increased 4.8, CSF culture negative, protein 42, glucose 51, west Nile virus IgG 0.08, west Nile virus IgM 0.02. EMG abnormal supportive of primary demyelination. Mildly prolonged distal and F-wave latencies, borderline velocities in scattered distribution and prolonged blink latencies. MRI and MRA normal.   9/23/09 Lab results received DOS 9/18/08 to 9/27/08. CSF - YF IgM (+) with PRNT <2.	UNK	UNK	None	None 10/27/08-records received-Recent travel to South East Asia with diarrheal illness followed by 2-4 weeks of finger tip numbness which resolved over past 6 weeks.	None 10/27/08-records received-PMH: lower back disease due to lumbar disk herniation, meniscal tear in left knee times 2.			1						1	Blood product transfusion; CSF glucose normal; CSF protein normal; CSF white blood cell count negative; Demyelination; Electromyogram abnormal; Fatigue; Guillain-Barre syndrome; Hypoaesthesia; Hypokinesia; Muscular weakness; Red blood cells CSF positive	FLU3~SANOFI PASTEUR~U2750AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB670AA~1~ID~RA~HEP B (ENGERIX-B)~1|MNQ~SANOFI PASTEUR~U2669AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|YF~SANOFI PASTEUR~UF426AA~1~SC~LA~YELLOW FEVER (YF-VAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0327876	10/09/2008	MN	62.0	62		F	10/09/2008	patient called day of administration (10/7/08 about 11:30 AM)reporting some itching on injection site, resolved with hydrocortisone cream application.  Came in for evaluation 10/9/08.  Site slightly bruised (on aspirin therapy)slightly raised and red about 2 cm x 4cm oval, warm to touch.  Patient has been icing area and applying hydrocortisone to site.  I advised a check by her doctor to r/o possible reaction to bandage, but area looks like possible injection site reaction to vaccine with secondary infection.  Patient is also diabetic and higher risk for secondary infections.  Pending patient follow up after MD appointment.  Patient reports never having a reaction with influenza vaccine in past history, but un-reported number if times received injection in past.				Y					U	10/07/2008	10/07/2008	0	patient may get labwork/WBC count	UNK	PVT	unknown	none reported by patient at screening	diabetes			1						1	Infection; Injection site bruising; Injection site erythema; Injection site pruritus; Injection site reaction; Injection site swelling; No reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~U2767AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0327877	10/09/2008	MA	3.0	3		F	10/09/2008	FLU SHOT GIVEN ON 10072008. RED, SLIGHTLY RAISED,HOT 7.5X6CM									U	10/07/2008	10/07/2008	0	NONE	PVT	PUB	NONE	NONE	ASTHMA			1						1	Erythema; Skin warm; Swelling	FLU3~SANOFI PASTEUR~U2828AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327878	10/09/2008	MI	58.0	58		M	10/09/2008	PATIENT WAS PRESENTED WITH A RED, HOT RASH ON HIS ARM AT INJECTION SITE WITH A WHITE STREAK RUNNING TOWARD THE ARM PIT.									Y	10/06/2008	10/08/2008	2	NONE	UNK	PUB	UNKNOWN	UNKNOWN	UNKNOWN			1						1	Injection site erythema; Injection site rash; Injection site streaking; Injection site warmth	FLU3~CSL LIMITED~0234911A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~0990U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327879	10/09/2008	TX	2.0	2	.0	M	10/09/2008	Parents begin to slowly notice that child began to not make milestones appropriate for his age. He slowly stopped doing appropriate behaviors for his age and began to regress. Child continued to lose language he had previously had and could not work simple puzzles that had been easily mastered.  1/23/09 Received Neuro medical records of  12/20/2005-2/23/2006. FINAL DX: Autism, static encephalopathy, speech deficits Records reveal patient was in early intervention program when evaluated.  Socialization skills were delayed, speech mostly jargon, poor eye contact, unable to follow simple commands, stereotypical repetitive behavior.  10/28/08 Reviewed PCP office records of 10/31/05. FINAL DX: delayed expressive speech, allergy.   On day of Hep A vax (no record of flu vax), pt w/recent ear infection & cough.  PCP noted delayed speech & referred to early childhood intervention.								Y	N	10/31/2005	10/31/2005	0		UNK	UNK		Rash, allergies	Child had recurrent ear infections as a baby and was diagnosed with Hypohydrotic Ectodermal Dysplasia at 2 years old.Severe eczema as a baby  PMH: Grinds teeth.  Allergy: sudafed.  Poor feeder in infancy.	Began to not meet developmental milestones~Measles + Mumps + Rubella + Varicella (ProQuad)~1~1.00~In Patient		1						1	Childhood disintegrative disorder; Regressive behaviour; Speech disorder developmental	FLU3~SANOFI PASTEUR~u1814aa~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~b085453~1~UN~RL~HEP A (HAVRIX)~1	USA	Disabling	Influenza
0327881	10/09/2008	VA	69.0	69		F	10/09/2008	PT RECEIVED INFLUENZA VACCINE, AND AS ADMINISTRATOR WAS ATTEMPTING TO ACTIVATE THE SAFETY GLIDE FEATURE OF THE SYRINGE, THE ADMINISTRATOR WAS STUCK BY THE NEEDLE IN THE RIGHT FIRST FINGER.									Y	10/09/2008	10/09/2008	0		UNK	UNK	NONE	NONE	NONE			1						1	Accidental exposure; Accidental needle stick	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA388BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0327883	10/09/2008	ID	24.0	24		F	10/09/2008	This was the patient's first flu shot.  Within 2 minutes of receiving the vaccine she started to complain of loss of vision, feeling very hot and had labored breathing.  911 was immediately contacted.  The patient remained responsive and started to complain of numbness and tingling in extremities.  I gave the patient 50mg diphenhydramine by mouth.  When the paramedics arrived they took her vitals and determined she was having a vagal response.  At this point the patient was feeling better and breathing and eye sight were back to normal.  She refused additional medical treatment from the paramedics and after 30 minutes returned to work by escort.  She remained under close supervision of a co-worker for the rest of the work day.									Y	10/08/2008	10/08/2008	0	Paramedics took blood pressure upon arrival and it was 90/70.  She was given oxygen for 5 minutes and O2 sats were normal.	UNK	UNK						1						1	Dyspnoea; Feeling hot; Hypoaesthesia; Oxygen saturation normal; Paraesthesia; Syncope vasovagal; Visual disturbance	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0327889	10/09/2008	CA				U	10/09/2008	This case was reported by a pharmacist and described the occurrence of itching in an adult subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In 2008 the subject received unspecified dose of FLUARIX (unknown). In 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced itching, increased heart rate, rash and trouble breathing. The pharmacist considered the events were disabling, life threatening and clinically significant (or requiring intervention). The subject was treated in the emergency room. Treatment was not specified. At the time of reporting the outcome of the events was unspecified. The pharmacist considered the events were probably related to vaccination with FLUARIX. A product complaint was reported. The pharmacist reported that 5 to 7 adults (exact number unknown) who are employees of the hospital experienced reactions to FLUARIX. The events known to the reporter were documented above. It was noted that there could be additional events. All of the subjects had to be treated in the emergency room. Details of the treatment were not specified. Limited subject information was known at the time of reporting. The pharmacist only knew one lot number, but there may have been others (unknown at the time of reporting). These 5 to 7 subjects are out of a total of 22 doses of FLUARIX given. Due to the high rate of reactions, the hospital stopped using the FLUARIX because they feel the reactions are due to a quality issue with the product.			Y	Y				Y	U				UNK	PVT	PVT		Unknown			A0751184A	1						1	Dyspnoea; Heart rate increased; Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU356AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Life Threatening,Disabling	Influenza
0327890	10/09/2008	VA	64.0	64		F	10/09/2008	This case was reported by a healthcare professional and described the occurrence of hypoglycemia in a 64-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included diabetes controlled by diet and heart disease. There were no concurrent medications. On the morning of 7 October 2008 the subject received unspecified dose of FLULAVAL at 0.5 ml. On 7 October 2008, about 1 hour after vaccination with FLULAVAL, the subject experienced hypoglycemia and sleepiness. This case was assessed as medically serious by GSK. Product complaint was reported. At the time of reporting the outcome of the events was unspecified. The reporter stated that they gave 20 doses of FLULAVAL in the morning and three subjects reported hypoglycemia.									U	10/07/2008	10/07/2008	0	UNK	OTH	OTH	No concurrent medication	DIABETES, HEART DISEASE	The subject was newly diagnosed with diabetes controlled by diet, no insulin.		A0751216A	1						1	Hypoglycaemia; Somnolence	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA185AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0327891	10/09/2008	VA	77.0	77		M	10/09/2008	This case was reported by a healthcare professional and described the occurrence of hypoglycemia in a 77-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject is not a diabetic and has a history of chronic kidney disease, stage 4 and on on dialysis. Also has a medical history of anemia and currently has hypertension. There were no concurrent medications. On the morning of 7 October 2008 the subject received unspecified dose of FLULAVAL at 0.5 ml. On 7 October 2008, about 1 hour after vaccination with FLULAVAL, the subject experienced hypoglycemia, sleepiness, lack of energy and feeling unwell. This case was assessed as medically serious by GSK. Product complaint was reported. At the time of reporting the outcome of the events was unspecified. The reporter stated that they gave three doses of FLULAVAL in the morning and three subjects reported hypoglycemia.									U	10/07/2008	10/07/2008	0	UNK	OTH	OTH	No concurrent medication	ANEMIA, HYPERTENSION, RENAL DISEASE	The subject is not a diabetic and has a history of chronic kidney disease, stage 4 and not on dialysis. Also has a medical history of anemia and currently has hypertension.		A0751218A	1						1	Asthenia; Hypoglycaemia; Malaise; Somnolence	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA185AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0327892	10/09/2008	VA	43.0	43		F	10/09/2008	This case was reported by a healthcare professional and described the occurrence of hypoglycemia in a 43-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject is not a diabetic and receives unspecified thyroid medication concurrently. On the morning of 7 October 2008 the subject received unspecified dose of FLULAVAL at 0.5 ml. On 7 October 2008, about 1 hour after vaccination with FLULAVAL, the subject started to feel bad and experienced hypoglycemia (drop in blood sugar to 17 per serum test) and sleepiness. Fatigue was also documented. This case was assessed as medically serious by GSK. Product complaint was reported. The subject was given orange juice and peanut butter crackers and about 30 minutes later, her blood sugar was 49. At the time of reporting the outcome of the events was unspecified. The reporter stated that they gave 20 doses of FLULAVAL in the morning and three subjects reported hypoglycemia.									U	10/07/2008	10/07/2008	0	Blood sugar decreased, 17; Sugar blood level increased, 49	OTH	OTH	Thyroid medication	Unknown	The subject is not a diabetic and receives thyroid medication.		A0751219A	1						1	Blood glucose decreased; Fatigue; Feeling abnormal; Hypoglycaemia; Somnolence	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA185AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0327898	10/09/2008	CO				F	10/09/2008	Flu like symptoms. Fever, hot/cold intervals Red and painful sit.				Y					U	10/08/2008	10/08/2008	0		OTH	PVT						1						1	Feeling of body temperature change; Influenza like illness; Injection site erythema; Injection site pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~UFHA1530A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0327899	10/09/2008	NM	67.0	67		F	10/04/2008	Daughter called 10-4-08 reporting her mother's right arm was very red clear down past the elbow, hot to the touch and painful.  Daughter is an RPh and had instructed mom to ice it and take Tylenol for the pain - will keep an eye on it and see MD on Monday if needed.									Y	10/02/2008	10/03/2008	1		OTH	PVT		None	None			1						1	Erythema; Pain in extremity; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0963U~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327900	10/09/2008	WA	62.0	62		F	10/09/2008	8hrs after receiving shot pt complained of dizzyness sweating fever heart palpitations legs tingling									Y	10/03/2008	10/03/2008	0		OTH	PVT						1						1	Dizziness; Hyperhidrosis; Palpitations; Paraesthesia; Pyrexia	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327901	10/09/2008	CO	36.0	36		M	10/09/2008	3cc dose adm. drug error 6 dose injection arm red, painful @ site.									U	10/08/2008	10/08/2008	0		OTH	PVT						1						1	Incorrect dose administered; Injection site erythema; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA153BA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0327902	10/09/2008	CO	31.0	31		M	10/09/2008	3 cc dose administered. Drug error 6 dose injection. Arm red painful @ injection site.									U	10/08/2008	10/08/2008	0		OTH	PVT					WAES	1						1	Incorrect dose administered; Injection site erythema; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA153AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0327903	10/09/2008	CO	58.0	58		F	10/09/2008	3 cc dose administered. Arm red, painful @ injection site.				Y					U	10/08/2008	10/08/2008	0		OTH	OTH					WAES	1						1	Incorrect dose administered; Injection site erythema; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA153AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0327905	10/09/2008	CA	8.0	8		F	10/09/2008	Rt. deltoid presents with redness & edema 2 x 3; pt reports much better at 5pm next day.									Y	10/08/2008	10/09/2008	1	NONE	PUB	PUB			tends to run high fevers 2+ x's/yr			1						1	Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~U2769AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1672U~4~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TD~SANOFI PASTEUR~U1959BB~6~IM~LA~TD ADSORBED (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~1594U~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0327906	10/09/2008	CA	45.0			F	10/09/2008	She got pain and muscle cramps at site of injection w/in 5 minutes. After 2 hrs, she felt nauseated and severe migraine headache that lasts until the next day.									Y					OTH	PVT		pain at site of injection, N/V, Headache		~Influenza (Seasonal) (no brand name)~1~0.00~In Patient	WAES	1						1	Immediate post-injection reaction; Injection site pain; Migraine; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0327910	10/09/2008	CA	29.0			F	10/09/2008	She got a tingling and numbness sensation in her left arm within half an hour. Then she felt nauseated. She then threw up twice. She felt dizzy and had a severe migraine headache. I asked her to go to the ER but she didn't go. She went to her doctor's office the next day.									U					OTH	PVT		tingling, numbness, N/V, dizziness		~Influenza (Seasonal) (FluLaval)~1~29.00~In Patient	WAES	1						1	Dizziness; Hypoaesthesia; Migraine; Nausea; Paraesthesia; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0327921	10/09/2008	ME	50.0	50		F	10/09/2008	Facial, ear, chest rash. Flushed. Throat felt clogged.				Y					Y	10/07/2008	10/07/2008	0		PUB	PUB			Bleach; Eggs ( ok with prior FLUVAX); Aspirin; PCN; Morphine; Oxycodone; Codeine			1						1	Flushing; Rash; Throat tightness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89623~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0327922	10/09/2008	ME	1.3	1	.3	M	10/09/2008	Lethargic (pt demonstrated this same side effect when he received his previous vaccinations). O.5 ml given instead of 0.25 ml.									Y	10/08/2008				PVT	PUB	None	None	None			1						1	Incorrect dose administered; Lethargy; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U2828AA~UNK~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327923	10/09/2008	VA	36.0	36		F	10/09/2008	11/9/2007 - FluMist given.  She received vaccine about 12 noon, then returned to wk.  Approximately 8 pm she began to sneeze.  The next day she had sniffles, sneezing worse and diffuse aches (like a cold).  The next day, Sunday, she had a cough.  She went to Urgent Care on Monday c/o temp 101, stuffy head, congestion, cough and treated for URI w/meds and given NFW for 2-3 days.  Symptoms lasted 2 weeks.				Y					Y	11/09/2007	11/09/2007	0	Unk	UNK	MIL	Denied	Denied	Migraines; Seasonal allergies			1						1	Cough; Headache; Pain; Pyrexia; Respiratory tract congestion; Rhinorrhoea; Sneezing; Upper respiratory tract infection	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0327924	10/09/2008	PA	76.0			F	10/06/2008	Adult patient inadvertently received incorrect vaccine on 10/1/08. Patient received pediatric Dtap. Patient stated he had no adverse effects from the vaccine.									U	10/01/2008				PVT	PVT			Type II DM; hypercholesterolemia			1						1	Wrong drug administered	DTAP~SANOFI PASTEUR~C2952BA~1~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2758AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327926	10/09/2008	MA	68.0	68		F	10/08/2008	C/O pain in left upper arm since flu shot, and lateral aspect of left shoulder. Pain with ROM in left shoulder. NO redness, no swelling, no effusion of (L) shoulder and no ecchymosis noted. Tx: Alternate hot and cold compress, soak in warm tub. Tylenol #3 for pain. Follow-up as needed.				Y					U	10/03/2008	10/03/2008	0	None	PVT	PVT	Vit. D, D3-50; Lolatadine; TYLENOL #3	None	COPD; Fibromyalgia; Multple Sclerosis; Hyperlipidemia	Arm swollen and red.~Td Adsorbed (no brand name)~UN~57.00~In Patient		1						1	Joint range of motion decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2747AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0327930	10/09/2008	CO	0.7	0	.7	F	10/09/2008	3cc administration. Drug error arm painful, red at injection site.									U	10/08/2008	10/08/2008	0		UNK	UNK						1						1	Injection site erythema; Medication error; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA153BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0327931	10/09/2008	CO	9.0	9		F	10/09/2008	3 cc administered - drug error. Arm painful red @ injection site.									U	10/08/2008	10/08/2008	0		OTH	PVT						1						1	Injection site erythema; Injection site pain; Medication error	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88805~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0327933	10/09/2008	CO	31.0	31		F	10/09/2008	3 cc administered - drug error - 6 dose injection. Arm painful, red @ injection site.									U	10/08/2008				OTH	OTH						1						1	Injection site erythema; Injection site pain; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA153BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0327934	10/09/2008	CO	50.0	54		M	10/09/2008	3 cc administered (drug error), 6 dose inj. Arm painful and red @ injection site.									U	10/08/2008	10/08/2008	0		OTH	PVT			Unknown			1						1	Injection site erythema; Injection site pain; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA153AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0327936	10/09/2008	CO	57.0	56		M	10/09/2008	3 cc administered (drug error). 6 dose injection. Arm painful, red @ injection site.									U	10/08/2008	10/08/2008	0		OTH	OTH						1						1	Injection site erythema; Injection site pain; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA155BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0327937	10/09/2008	CO	58.0	58		F	10/09/2008	3cc admin. Drug error 6 dose injection. Arm painful red at site.									U	10/08/2008	10/08/2008	0		OTH	PVT						1						1	Injection site erythema; Injection site pain; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA153AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0327939	10/09/2008	CO	27.0	27		F	10/09/2008	3 cc dose administered - drug error. 6 dose injection. Arm red, painful @ inj. site.									U	10/08/2008	10/08/2008	0		OTH	PVT						1						1	Injection site erythema; Injection site pain; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA153AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0327940	10/09/2008	CO	3.0	4		F	10/09/2008	3 cc dose administered - drug error. 6 dose injection. Arm red, painful @ injection site.									U	10/08/2008	10/08/2008	0		OTH	PVT						1						1	Injection site erythema; Injection site pain; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA153BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0327942	10/09/2008	CO	46.0	45		F	10/09/2008	3 cc dose adm. Drug error. 6 dose injection. Arm red, painful @ site.									U	10/08/2008	10/08/2008	0		OTH	PVT						1						1	Incorrect dose administered; Injection site erythema; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA153BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0327885	10/10/2008	PA	51.0	57		F	10/10/2008	redness, swelling, tenderness at vaccination site				Y					U	10/07/2008	10/09/2008	2	none	UNK	UNK						1						1	Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0327981	10/10/2008	FL	67.0	67		F	10/06/2008	(L) arm swelling, itching, soreness, nausea, temp. Hospitalized 3 days. Ice pack and Benadryl. Did EKG and ECHO. 10/15/08 Reviewed hospital medical records of 10/2-10/04/2008. FINAL DX: local vaccine reaction Records reveal patient experienced weakness, nausea, itching, injection site swelling, induration & erythema left deltoid.  Cardiology consult done.					Y	3			Y	10/02/2008	10/02/2008	0	Pt states EKG and ECHO  LABS: CBC, chemistry WNL.  CK, CK-MB & troponin all WNL.  CXR abnormal w/massive cardiomegaly.  ECG abnormal w/ST-T changes c/w LV hypertrophy & old anterolateral infarction.  Echocardiogram abnormal w/ejection fraction 50%.  US of LUE WNL.	PUB	PUB		None	NKA  PMH: heart valve replacement, chronic atrial fibrillation, long term anticoagulant therapy, HTN, OA, bipolar disese, non-smoker.			1						1	Body temperature increased; Nausea; Oedema peripheral; Pain; Pruritus	FLU3~SANOFI PASTEUR~U2793DA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0990U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0327982	10/10/2008	TX	69.0	69		M	10/06/2008	Chronic inflammatory demyelinating neuropathy attack.  1/19/09 Reviewed hospital d/c summary for 1/8-1/12/2008. FINAL DX: chronic inflammatory demyelinating polyradiculopathy. Records reveal patient experienced recurrence of pain, weakness of right leg, low back pain, difficulty sleeping.  Tx w/IVIG x 5 days w/improvement.  D/c to home with on continued pain management w/neuro outpatient f/u.  1/8/09 Reviewed PCP medical records for 7/22/08-10/24/08 FINAL DX: recurrent chronic inflammatory demyelinating polyradiculopathy Records reveal patient experienced right hip pain, arthritis, constipation, insomnia, hyperesthesia of skin & dx w/herpes zoster, tx w/antiviral meds. 7/22/08 record indicates pt recently released from hosp s/p chronic demyelinating polyradiculopathy.  Continued to have pain, difficulty walking, gait disturbance, depression & falling down at that time.    12/2/08 Reviewed hospital medical records of 10/16-10/19/2006. FINAL DX: chronic inflammatory demyelinating polyradiculopathy Records reveal patient experienced recurrent pain & weakness left leg beginning 9/2006.  Admitted for IVIG x 4 days.  Improved & d/c to home.  10/27/06 GI consult done for normocytic normochromic anemia & colonoscopy.				Y	Y	10			Y	10/09/2007			EMG/NCV  LABS: EMG/nerve conduction studies 12/2005 abnormal.	PVT	PVT		None	None  PMH: chronic inflammatory demyelinating polyradiculopathy since 12/2005; DM II w/renal & ophthalmic manifestations; adrenal nodule; mixed hyperlipidemia; cervical disc degeneration; benign HTN; diabetic amyotrophy.  Allergy: flu vax, ace inhibitors.  PMH: Diabetic amyotrophy w/left leg/hip pain, falls, sleep disturbance, starting 7/2005. Hospitalized 12/2005 for tx w/IVIG.  Back & retinal surgery.  Arthritis.  HTN.  Ex-smoker.			1						1		FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80070~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0327984	10/10/2008	CA	54.0	54		F		Arm swollen for 4 days after shot; also body aches, chills, and stomach upset. Lost 2 days of work due to adverse reaction. 1st time ever.									Y	09/29/2008	09/29/2008	0		PUB	PVT		None				1						1	Activities of daily living impaired; Chills; Oedema peripheral; Pain; Stomach discomfort	FLU3~SANOFI PASTEUR~U2768AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327985	10/10/2008	MT	42.0	42		F	10/05/2008	5,OCT,2008 reports to clinic with malaise/fatigue and chills. Pt states symptoms developed 4,OCT,2008 afternoon. Experienced N/V/Chills. Woke up vomiting 3 to 4 times last noc. Cannot keep food or liquids down today. Reported to clinic 09:15 5,OCT,2008.				Y					Y	10/04/2008	10/04/2008	0		MIL	MIL		Tired, worn out	Penicillin; AMOXICILLIN; POLYMOX CAINE family			1						1	Chills; Fatigue; Malaise; Nausea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500551P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0327987	10/10/2008	MA	64.0	64		F	10/03/2008	Left and right arms, warm, swollen.  Increased pain started to hurt at 8 PM 10/01/08.  Took Tylenol with no relief.  10/03/08 no improvement.  10/6/08 Improved.									Y	10/01/2008	10/01/2008	0	None	PUB	PUB	Unknown	None	Allergic to IVP Contrast Dyes			1						1	Oedema peripheral; Pain in extremity; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFUA191AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1132U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327989	10/10/2008	TX	54.0	54		F	10/02/2008	3 pm (L) side neck stiff. 5 pm (L) side neck pain. 7 pm (L) shoulder pain, radiating down to elbow with muscle spasm from shoulder to elbow. Could not sleep due to pain, 9/6/08. 9/30/08, increase pain (L) neck to elbow, per MD, use ice/heat/ADVIL 400 mg, every 4 hours. 10/1/08, in MD office, Cortisone injection to (R) arm. TENS unit applied x 30 mins. Amp 1x 15 mg, Hydrocodone 10 mg. Rx given 10/2/08. Back to MD for TENS unit therapy - off work 3 days.									U	09/29/2008	09/29/2008	0	None	PUB	PUB	SYNTHROID; AVALIDE; PREMARIN; NORVASC; GLIMERIDE	None	Hypothyroid; HTN; NIDDM			1						1	Activities of daily living impaired; Muscle spasms; Musculoskeletal pain; Musculoskeletal stiffness; Neck pain; Sleep disorder	FLU3~SANOFI PASTEUR~U2768AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327990	10/10/2008	WA	36.0	36		F	10/01/2008	About 15 minutes after receiving flu shot.  I began to feel tightness of my throat and chest and head and difficulty breathing. About 2 hours later I began to feel urgency to cough and my throat more tight about 6 hours after the shot I began having body aches, muscle pain and fever of 100. Resolving throat and head tightness and congestion.									Y	09/30/2008	09/30/2008	0		PUB	PVT	Supplements; vitamins		CT scan contrast fluid			1						1	Chest discomfort; Cough; Dyspnoea; Myalgia; Pain; Pyrexia; Tension headache; Throat tightness; Upper respiratory tract congestion	FLU3~CSL LIMITED~02349111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0327991	10/10/2008	MA	87.0	87		F	10/03/2008	FLU AND PNEUMO in (R) arm, Wed NOC, redness, rash at injection site, weakness of legs, unsteady - Improved by Mon 10/6/08				Y					Y	10/01/2008	10/01/2008	0		PUB	PUB		None	None			1						1	Balance disorder; Injection site erythema; Injection site rash; Muscular weakness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFUA191AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1132U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0327993	10/10/2008	WA	28.0	28		F	10/02/2008	immediate reaction dizzy, flushed, nausea, headache (sharp) photophobia Resolved after 10 minutes									Y	10/02/2008	10/02/2008	0		PVT	UNK						1						1	Dizziness; Flushing; Headache; Immediate post-injection reaction; Nausea; Photophobia	FLU3~SANOFI PASTEUR~U2745AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0327994	10/10/2008	IL	53.0	53		F	10/06/2008	Rash started one day later (red with small bumps)									U	10/04/2008	10/05/2008	1		OTH	UNK	OMEPRAZOLE, NASONEX, ALBUTEROL, LOMOTIL, LASIX, POTASSIUM, LEVOTHYROXINE, CARTIA, SPIRIVA, IBUPROFEN, ADVAIR					1						1	Rash erythematous; Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89880~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0327995	10/10/2008	CA	47.0	47		F	10/04/2008	Broke out into rashes									U	10/02/2008	10/04/2008	2		OTH	PVT		No	Milk sensitivity			1						1	Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0327996	10/10/2008	UT	6.0	6		F	10/06/2008	red spot - sore to touch - hot to touch - antibiotic & benedryl treatment				Y						10/01/2008	10/03/2008	2		UNK	PVT	None	None	None			1						1	Erythema; Pain; Skin warm	FLU3~SANOFI PASTEUR~U2763AA~5~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0327997	10/10/2008	MI				U		Generalized maculopapular erythema drug reaction rash				Y					Y	10/02/2008	10/02/2008	0	None	PVT	PVT	None	None	None			1						1	Rash erythematous; Rash maculo-papular	FLU3~SANOFI PASTEUR~02755AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328010	10/10/2008	IL				F	10/10/2008	This case was reported by a healthcare professional and described the occurrence of sensitivity to latex in an adult (age 25 to 30 years) female subject who was vaccinated with FLUARIX (GlaxoSmithKline) and ADACEL (Merck).  In November 2006 the subject received a dose of FLUARIX at 0.5 ml and ADACEL.  At an unknown time following vaccination with FLUARIX and ADACEL, the subject likely developed a latex sensitivity.  The event was unresolved and considered to be probably related to treatment with FLUARIX.  In November 2007, the subject again received a dose of FLUARIX at 0.5ml.  Fifteen minutes after vaccination with FLUARIX, the subject developed hives and itching.  The subject was treated in the emergency room with BENADRYL and symptoms resolved after an unknown time period.  The healthcare professional considered the events were clinically significant (or requiring intervention).  The healthcare professional considered the events were probably related to vaccination with FLUARIX.				Y					N	11/01/2006			UNK	PVT	PVT		Unknown	The subject has previously received FLUVIRIN in 2005 without any reactions. It was reported that the subject had experienced hives and itching following previous vaccinations, however, none were specified.		A0751260A	1						1	Latex allergy; Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|TDAP~SANOFI PASTEUR~~UNK~UN~UN~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0328011	10/10/2008	OH	13.0	13		F	10/10/2008	This case was reported by a healthcare professional and described the occurrence of lost consciousness in a 13-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). There were no concurrent medications. On 4 October 2008 at 10:45 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. Immediately after vaccination with FLULAVAL. the subject experienced lost consciousness. Ammonia was used on the subject and she did come around. The subject was only out for about 30 seconds. Paramedics were called and they came out to check on the subject. The subjects mother took her to the emergency room, but she was released. This case was assessed as medically serious by GSK. The healthcare professional considered the event was unrelated to vaccination with FLULAVAL. This was also considered to be a case of medication error as FLULAVAL is not indicated for use in children.				Y					Y	10/04/2008	10/04/2008	0	Unk	OTH	PVT	No concurrent medication	Unknown	The subject has a history of loss of consciousness in the past with other vaccines.		A0751362A	1						1	Condition aggravated; Immediate post-injection reaction; Loss of consciousness; Medication error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA207AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0328012	10/10/2008	FL	71.0	71		F	10/10/2008	This case was reported by a consumer and described the occurrence of not responsive in a 71-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  Concurrent medical conditions included anxiety and premature ventricular contraction.  Concurrent medications included TOPROL XL, ZOLOFT, Omega 3 fish oil, Vitamin C, Vitamin E and Co q 10.  On 1 October 2008 at 10:00 the subject received a dose of FLULAVAL in the left arm.  On the night of 1 October 2008, less than one day after vaccination with FLULAVAL, the subjects husband reported that she was in bed making funny gurgling noises.  At that time, the subject was also unresponsive and her eyes were rolled back.  The subject awoke in an ambulance and was unsure how she got there.  She was taken to the emergency room and was admitted to the hospital.  Physicians performed a CAT scan and an MRI which were both negative.  An EEG was also performed, but the results were pending.  The subject was discharged the following day.  The physicians told the consumer that it appeared as if she might have experienced a seizure, but they weren't sure what the cause might have been.  One physician apparently questioned whether the event was a result of the subject receiving the FLULAVAL vaccine.  A sleep apnea study was planned at the time of reporting.  The outcome of the events was not reported.				Y	Y	1			U	10/01/2008	10/01/2008	0	October 2008: Physicians performed a CAT scan and an MRI which were both negative.  An EEG was also performed, but the results were pending.	PVT	OTH	Metoprolol succinate; Sertraline hydrochloride; Omega-3 marine triglyceri; Ascorbic acid; Vitamin E; Ubidecarenone	Anxiety; Premature ventricular contraction	The subject has received flu vaccine in the past and has no history of any reactions following flu vaccine or any previous vaccinations.		A0751380A	1						1	Altered state of consciousness; Computerised tomogram normal; Electroencephalogram; Gaze palsy; Increased bronchial secretion; Nuclear magnetic resonance imaging normal; Unresponsive to stimuli	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0328046	10/10/2008	TN	19.0	18		M	10/10/2008	Pt. received the flu shot on Friday around 2:30.  While eating lunch Saturday his vision became blurred, face felt numb and and was twitching.  No difficulty breathing.  Parents took him to the ER.  Blood and urine tests all WNL.  CAT scan neg.  Advised to f/u with neurologist on Monday.  Sunday he was fine.  Monday went to school but didn't feel quite right.  Saw the neurologist - MRI was done and it was normal.  Has occassional HA, but nothing like at first.									Y	10/03/2008	10/04/2008	1	Blood and urine WNL     CAT scan and MRI normal Normal Neuro exam	PVT	PVT	None	None	None			1						1	Blood test normal; Computerised tomogram normal; Headache; Hypoaesthesia facial; Muscle twitching; Neurological examination normal; Nuclear magnetic resonance imaging normal; Urine analysis normal; Vision blurred	FLU3~SANOFI PASTEUR~U2809AA~5~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328049	10/10/2008	TX	37.0	37		F	10/10/2008	Area warm to touch, red, sore. Larger than half-dollar size.  Also c/o nausea.									U	10/08/2008	10/09/2008	1		PUB	UNK		none	unknown			1						1	Erythema; Nausea; Pain; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88635~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0328050	10/10/2008	AL	58.0	58		F	10/06/2008	Patient called on 10-03-08 at 8:55 A.M. Complained of left arm being red, hot tender to touch with swelling. Stated she halos had a rash and was having tingling to same arm which was getting worse.  Patient also complained of having a headache. Patient stated this was noticed some time on the A.M. of 10-03-08.Patient was prescribed Prednisone by her private physician.				Y					Y	10/01/2008	10/03/2008	2		UNK	UNK	Arthritis, Cholesterol	None	Arthritis, High Cholesterol		AL0826	1						1	Erythema; Headache; Oedema peripheral; Paraesthesia; Rash; Skin warm; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA349BB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0328051	10/10/2008	MI	63.0	63		M	10/10/2008	allergic reaction patient complained of respiratory difficulty, PRN respiratory tx administered per RT x 1.  Upon entering room RN noticed audible stridor.  Patient continued to complain of respiratory difficulty after 2 prn tx.  Physician notified and orders received.  Benadryl IV administered d/t same problem with another patient.  Flu vaccine or pneumonia vaccine given earlier, suspected as possible cause										10/09/2008	10/10/2008	1		PUB	PVT	tobramycin, zosyn, novolin r, albuterol, aspirin, citalopram, combivent, desenex, flomax, furosemide, guaifenesin, ipratropium, jantoven, kovia, lanoxin, lantus, lipitor, lisinopril, magox, metolazone, metoprolol, potassium chloride, simeth	Per 10/9/08 progress note, respiratory failure, sepsis, stroke, uti, PAT, CAD, renal insufficiency, remaining note illegible.	no known medical allergies noted on chart			1						1	Cerebrovascular accident; Coronary artery disease; Dyspnoea; Hypersensitivity; Renal failure; Respiratory failure; Sepsis; Stridor; Urinary tract infection	FLU3~CSL LIMITED~0264911A~UNK~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~0993U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328053	10/10/2008	MI	55.0	55		F	10/10/2008	0010 - pt c/o itching, burning, rash noted on arms, thighs, back, buttocks, as increase shortness of breath noted.  Dr called Benadryl given then pt started becoming nauseated.  Called Dr back Zofran ordered. Pt did have a flu shot today, but not a pneumo vac. RN										10/08/2008	10/10/2008	2		UNK	UNK	fortaz, ferrrous sulfate, folic acid, hydromorphone, spiriva, aranesp, arixtra, citalopram, desenex, ferrous sulfate, folic acid, hydrocodone/acetaminophen, kovia, metoprolol, pacerone, protonix, vitamin c, zinc sulfate, albuterol, alprazol	Per 10/9/08 progress note, abdominal wound, a-fib, copd, osa, obesity.				1						1	Dyspnoea; Nausea; Pruritus; Rash; Skin burning sensation	FLU3~CSL LIMITED~02649111A~UNK~IM~~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0328054	10/10/2008	MT	38.0	38		F	10/10/2008	She complained of SOB, heavy chest, shivers, aches.  She said she felt hot but did not take her temperature.  She called the doctor's office this a.m.									U	10/09/2008				UNK	UNK						1						1	Chest discomfort; Chills; Dyspnoea; Feeling hot; Pain	FLU3~SANOFI PASTEUR~U2757AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328055	10/10/2008	TX	25.0	25		F	10/10/2008	Employee states that she developed a Headache with in the first 12 hours after the vaccine that would not resolve after OTC meds. She then states she began to feel shaky and light headed and could not drive home. Once she was driven home she states she began to run fever (did not take temp) but felt hot on the inside and had cold chills along with body aches and muscle fatigue. She had an episode of tachycardia and SOB which resolved. She took OTC Tylenol and went to bed, waking up several times. She still had body aches and fatigue until around 4pm the day after the flu shot. At that time all her symptoms resolved and she felt better.									Y	10/07/2008	10/07/2008	0		UNK	PVT						1						1	Chills; Dizziness; Dyspnoea; Feeling hot; Headache; Muscle fatigue; Pain; Pyrexia; Sleep disorder; Tachycardia; Tremor	FLU3~SANOFI PASTEUR~U2848AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328056	10/10/2008	TX	46.0	46		F	10/10/2008	Developed rash on face and aching feeling in both arms and then later that day developed hives and rash all over body and had low grade temp. Employee states right axillary area is also sore/aching. No reaction to left arm. She is curretly taking Motrin and Benadryl									Y	10/09/2008	10/09/2008	0		UNK	PVT						1						1	Axillary pain; Pain; Pain in extremity; Pyrexia; Rash; Rash generalised; Urticaria	FLU3~SANOFI PASTEUR~U2848AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0881F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328057	10/10/2008	WI	12.0	12		M	10/10/2008	Varicella vaccine administered 10/7/08 Rt arm SQ. Came back to clinic 10/9/08 with redness to area measuring 6.5cm X 7.5cm and 101.2 temp. and adominal pain.				Y					U	10/07/2008	10/09/2008	2	Rapid strep test done - negative	UNK	UNK	Ambilify	none	encopresis, ADHD			1						1	Abdominal pain; Erythema; Pyrexia; Streptococcal identification test; Streptococcal identification test negative	FLUN3~MEDIMMUNE VACCINES, INC.~500559P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U2623AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2899AA~1~IM~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~0103x~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0328059	10/10/2008	NY	11.0	11		M	10/10/2008	Patient had 8cm redness around injections sites the day after the vaccines.  Two days after he had swelling of the left side of the face, eye swollen shut.  Temp 98.7  BP 118/88  Treatment was Benadryl and Orapred.									N	10/08/2008	10/10/2008	2	urine analysis-normal   quick strep test-negative	PVT	PVT	Advair, Singulair	none	asthma			1						1	Eye swelling; Injection site erythema; Streptococcal identification test negative; Swelling face; Urine analysis normal	FLU3~SANOFI PASTEUR~u2784ga~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~uf452ca~6~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0328060	10/10/2008	AZ	8.0	8		M	10/10/2008	SYncopal episode.  Passed leaving office.  Laid down on examination table for 30 minutes.  Felt better.  Driven home by mother, second episode.  Brought back to office.  Tolerated crackers and water.  Felt better, sent home.  Tired remained of the day.  Now asymptomatic.				Y					Y	10/08/2008	10/08/2008	0	CBC:  hct-47.5, hgb-16, wbc-8.3, pmn-51, lymph+mono-49, plt-280	PVT	PVT						1						1	Fatigue; Haematocrit normal; Haemoglobin normal; Lymphocyte percentage increased; Monocyte percentage increased; Neutrophil percentage decreased; Platelet count normal; Syncope; White blood cell count	FLU3~SANOFI PASTEUR~U2796AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328061	10/10/2008	MD	56.0	56		M	10/10/2008	I experienced a fever, difficulty breathing, wheezing, headache.  I received the shot about 9:00am and started noticing the symptoms that evening.									Y	10/08/2008	10/08/2008	0		PUB	UNK		None	None			1						1	Dyspnoea; Headache; Pyrexia; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328062	10/10/2008	WI	51.0	51		M	10/10/2008	Pt. reported facial erythema, injected conjunctiva, pharyngitis, nasal congestion and swelling of the lips approx. 4 hours after the influenza injection.  He took 1 claritin-D, which did not resolve the symtpoms.  He was evaluated by the EMT's 5 1/2 hours post injection.  He refused transport to ER.  He developed a fever lasting from 7 - 14 hours post injection.									Y	10/07/2008	10/07/2008	0	None	PUB	PUB	Unknown	None	None			1						1	Conjunctival hyperaemia; Erythema; Lip swelling; Nasal congestion; Pharyngitis; Pyrexia	FLU3~SANOFI PASTEUR~U2768AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328063	10/10/2008	VA	44.0	44		F	10/10/2008	Pt received vacination around 5:30 pm on 10/09/08. At apporoximately 3am on 10/10/08 pt woke up and reported experiencing: Really red eyes that were running and goopy; temperature of 102 F; muscle aches.  Pt reports that these symptoms resolved by the next morning and the only residual effect was slight headache.									Y	10/09/2008	10/10/2008	1		UNK	PVT	GABAPENTIN 100MG BID; ZOMIG 5MG PRN; MIDRIN PRN	none	Pt reports having a reaction almost identical to this reaction when she received a flu shot in 2006.  Pt received a flu shot in 2007 without any problems.			1						1	Body temperature increased; Eye discharge; Headache; Lacrimation increased; Myalgia; Ocular hyperaemia; Similar reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~u287aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328066	10/10/2008	OR	87.0	87		F	10/10/2008	patient developed symptoms of severe dizziness with nausea which started at 4pm and lasted 4 hours. patient got a flu shot at 11 am that day.									Y	10/03/2008	10/03/2008	0		UNK	UNK		none				1						1	Dizziness; Nausea	FLU3~SANOFI PASTEUR~u2742aa~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328067	10/10/2008	FL	28.0	28		F	10/10/2008	Headache within 30 min. of shot.  2 hrs. after shot felt poor.  Within next 4 hours, eyes got red, lip swelled, fever, chills, tremors, pressure in chest, heart pounding hard and could fell it beating in her legs.  Throat sore.  Took Motrin and went to bed 6 hours after shot and went to bed.  Better in AM.									Y	10/08/2008	10/08/2008	0	None	PUB	PVT						1						1	Chest discomfort; Chills; Headache; Lip swelling; Ocular hyperaemia; Palpitations; Pharyngolaryngeal pain; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U2806AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328069	10/10/2008	VA	51.0	51		M	10/10/2008	Vaccine was administered 10/8/08 at ~5:15PM. Approx 9:00PM I began to experience moderate headaches and body aches in my hips and legs. Symptoms continued thru the night and included heavy sweating and moderate dehydration then became severe by early AM of 10/9/08 and continued until early afternoon of 10/10/08. Mild fever of 100 degress was noted for a short period early AM 10/9/08. Symptoms began to lessen on 10/10/08 by ~2:00PM. No medical attention was obtained.									Y	10/08/2008	10/08/2008	0	N/A	UNK	UNK		None	None			1						1	Dehydration; Headache; Hyperhidrosis; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2771AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328070	10/10/2008	PA	64.0	64		M	10/10/2008	Patient got vaccine at around 9:40 am and returned to the pharmacy about 10 minutes latter saying he felt strange. Upon checking vitals, his BP was 196/99 and his pulse was 146.				Y					Y	10/09/2008	10/09/2008	0		PUB	PVT	unknown					1						1	Blood pressure increased; Feeling abnormal; Heart rate increased	FLU3~SANOFI PASTEUR~u2754aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328071	10/10/2008	CO	66.0	66		F	10/10/2008	12 hours after shot developed high fever, chills and muscle/joint pain.  Better in 24 hours.									Y	10/08/2008	10/08/2008	0		UNK	UNK	Symvastatin;Triamterine/Hctz; Levothyroxin	none	allergic to amoxicillin			1						1	Arthralgia; Chills; Myalgia; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~V04.81~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0328073	10/10/2008	TX	2.0	2	.1	M	10/10/2008	Hepatitis A vaccine and FluMist given 10/3/08.  On the morning of 10/9/08, school teacher reported trembling and inability to balance.  Parents noted irritability, trembling, inability to balance, and unbalanced gait.  Diagnosis was acute cerebellar ataxia. 10/24/08 Reviewed PCP medical records of 10/9- FINAL DX: acute cerebellar ataxia Records reveal patient experienced trembling, unbalanced, irritable, uncoordinated, bumping into walls on 10/9.  RTC 10/10 w/vomiting x 1 & decreased appetite.  Observed to have wide based gait & unsteady w/tremor of both hands & head.  Phone consult w/neuro & decided on observation.  Admitted to hospital 10/13-15.  11/11/08 Reviewed hospital medical records of 10/13-10/15/2008. FINAL DX: acute cerebellar ataxia Records reveal patient experienced ataxia & shakiness x 5 days. Neuro consult done.  Improved some in hospital & d/c to home w/outpatient PT/OT.				Y	Y	3			N	10/03/2008	10/09/2008	6	CBC, CMP, ESR, C-Reactive protein and Creatine Kinase were normal.  LABS: MRI brain WNL.	UNK	UNK	Tylenol, Vitamins	None	None			1						1	Balance disorder; Blood creatine phosphokinase normal; C-reactive protein normal; Cerebellar ataxia; Full blood count normal; Irritability; Laboratory test normal; Red blood cell sedimentation rate normal; Tremor	FLUN3~MEDIMMUNE VACCINES, INC.~500556P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~1258U~2~IM~RL~HEP A (HAVRIX)~1	USA	Hospitalisation	Influenza
0328074	10/10/2008	TX	35.0	35		F	10/10/2008	states later that day of the vaccine, had a knot to area.  area is now red, warm to touch, sore   Advised to take Benadryl for the reaction									U	10/08/2008	10/08/2008	0	none	PUB	UNK	unknown	none	unknown			1						1	Injection site erythema; Injection site mass; Injection site pain; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88635~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0328075	10/10/2008	MO	20.0	20		M	10/10/2008	Patient reports severe facial itching and redness and swelling 12-24 hours post treatment.  Redness and swelling significantly reduced at 72 hours.  Patient continues to have severe pruiritus.  Atarax 25mg 4 times daily prescribed for patient for continued symptoms				Y					U	10/03/2008	10/04/2008	1	N/A	MIL	MIL	None	None	None			1						1	Erythema; Pruritus; Swelling	FLUN3~MEDIMMUNE VACCINES, INC.~500557P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0328078	10/10/2008	TX	1.0	1	.0	F	10/10/2008	12 month vaccines given yesterday, 10/9/08.  Mom called the morning of 10/10/08 reporting itchy welts to bilateral legs.  Exam revealed an arthus reaction with no known exposure to insect bites.  She had 4 oval, raised erythematous lesions of 1cm x 1 cm on left outer leg, and two larger areas on right leg of 2x2 cm and 2x0.5cm with slight central clearing.  Will treat with Locoid steroid cream and Benadryl 1/2 tsp every 6 hours as needed.				Y					N	10/09/2008	10/09/2008	0	None	UNK	UNK	Axid 3ml daily	None	None			1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Injection site urticaria; Type III immune complex mediated reaction	FLU3~SANOFI PASTEUR~UT2782BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1209X~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C68312~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1890U~5~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0328080	10/10/2008	KS	32.0	32		M	10/10/2008	Vaccine administered around 14:00 on Sunday 10/5/2008.  Beginning Wednesday (10/8/2008) morning around 07:00, patient experienced significant GI upset, watery diarrhea, fever to 101 degrees Farenheit, significant body aches rated by patient as 7 out of 10 in severity.  Treated with fluids, bowel rest, acetaminophen, and ketoprofen.  Aches only responsive to ketoprofen.  Symptoms finally lessening and patient is now afebrile (15:00 on Friday 10/10/08).  Resulted in 3 missed days of work.									Y	10/05/2008	10/08/2008	3		PUB	PVT	Pantoprazole	No	Allergies: sulfa, tetracyclines, metronidazole topical;  Medical Conditions: irritable bowel syndome, GERD			1						1	Activities of daily living impaired; Diarrhoea; Gastrointestinal disorder; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328083	10/10/2008	MD	69.0	69		F	10/10/2008	10/7/08 - Pt received Pneumonia vaccine left arm,  pt also received Flu vaccine right arm. 10/10/08 (1600) - TC from pt w/following info:  Wed 10/8/08 - sx's began w/nausea, low-grade fever, passed out momentarily - went back to bed and stayed home from work rest of the day.  Back to work Thursday (10/9/08). Friday 10/10/08 - left arm red, hot area approx. 8 (even wrapped around a little).  Pt has taken Motrin & Tylenol since Thursday.  She states she had a little cold prior to vaccines, however, doesn't recall having a fever or other sx's.									Y	10/07/2008	10/08/2008	1	None	PUB	PUB	Unknown	Pt states 2 wks ago I had a clean-bill of health from my doctor.  However, a few days later she remembers having a mild head cold w/o fever.				1						1	Erythema; Loss of consciousness; Nausea; Pyrexia; Skin warm	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0224X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328085	10/10/2008	WI	11.0	11		F	10/10/2008	Redness in area of injection site where Varicella was given.				Y					Y	09/30/2008	10/02/2008	2		UNK	UNK		none	none			1						1	Injection site erythema	FLUN3~MEDIMMUNE VACCINES, INC.~500559P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0279x~1~IM~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~42623AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~0103x~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0328108	10/10/2008	CA	61.0	61		F	10/10/2008	Nose and part of cheeks became flushed, almost like a bad sunburn. nose felt warm to touch. Resolved after 1 hour. Felt restless that night and unable to sleep well. No tx.										10/09/2008	10/09/2008	0	None	PVT	PVT	MVI, thyrolar	none	allergies - PCN, Keflex			1						1	Feeling hot; Flushing; Restlessness; Sleep disorder	FLU3~SANOFI PASTEUR~U2740AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328110	10/10/2008	CO	69.0	69		F	10/10/2008	Allergic to Neomycin. Told pharmacist he replied that it was not a problem. After he administered the vaccine, he asked her did you say you are allergic to Neomycin. The next day she developed itching throughout the body, wheezing, felt nauseated, light headedness. Patient feels better today, but still sick. Pharmacist prescribed BENADRYL. Patient mentioned pharmacist should be severely reprehended due to this malpractice.									U	10/04/2008	10/05/2008	1	None	OTH	OTH	BENADRYL		Neomycin			1						1	Dizziness; Malaise; Nausea; Pruritus generalised; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0328111	10/10/2008	FL	58.0	58		F	10/10/2008	Pt. felt nauseated and dizzy. On 2 occasions she vomited.									Y	10/07/2008	10/07/2008	0		OTH	OTH	LISINOPRIL; HCTZ; NORVASC; VICODIN; PENTAC	None	Hypertension			1						1	Dizziness; Nausea; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA137AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0328112	10/10/2008	SC	0.5	0	.5	M	10/10/2008	Pt. received Polio vaccine instead of prescribed Flu vaccine.									Y	10/09/2008			None	PVT	PUB		OM; allergies	RAD; Migraines			1						1	Wrong drug administered	FLU3~SANOFI PASTEUR~U2828AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0491~UNK~IM~LA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0328113	10/10/2008	SC	2.8	2	.9	F	10/10/2008	Pt. received Polio vaccine instead of prescribed Flu vaccine.									Y	10/09/2008			None	PVT	PUB		OM; Folliculitis				1						1	Wrong drug administered	FLU3~SANOFI PASTEUR~U2828AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0491~UNK~IM~LA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0328114	10/10/2008	SC	3.0	3		F	10/10/2008	Pt. received Polio vaccine instead of prescribed Flu vaccine.									Y	10/09/2008			None	PVT	PUB	None	URI; RAD - stable	RAD; OM			1						1	Wrong drug administered	FLU3~SANOFI PASTEUR~U2828AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0491~UNK~IM~LA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0328115	10/10/2008	CA	62.0	62		M	10/09/2008	Received flu vaccination on Tues., 10/07/2008 at about 2:30 pm and Wed., 10/08/2008 at approximately 4 pm, developed whole body itch. No other symptoms. Went to family doctor - was examined and was given a BENADRYL shot. Within 20 minutes, itching had stopped has not returned. Sated is allergic to PNC, tetracycline, band aids with local reactive only. Has had flu vaccination last 40 years with no reaction.									Y	10/07/2008	10/08/2008	1	Physical exam for rash; none found per client	PUB	OTH	NORAD - pain; SOLATAL - anti-arrhythmia; PRILOSEC	None	Heart disease; allergic to PNC/tetracycline/band aids			1						1	No reaction on previous exposure to drug; Pruritus generalised	FLU3~SANOFI PASTEUR~U2749AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328116	10/10/2008	PA	42.0	42		F	10/10/2008	Felt stinging sensation when shot was administered, then lump formed immediately along with tenderness to touch. 5 cm bruise.									U	10/09/2008	10/09/2008	0		PVT	OTH						1						1	Contusion; Immediate post-injection reaction; Injection site pain; Mass; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA350AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0328117	10/10/2008	PA	25.0	25		M	10/09/2008	Pain at inj. site - 5 cm - bruise site.									U	10/08/2008	10/08/2008	0		PVT	OTH						1						1	Injection site haematoma; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA350AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0328118	10/10/2008	TN	42.0	41		F	10/10/2008	Red, slightly swollen, size of a tennis ball area occured approx. 24 hrs. of receiving influenza vaccine. No pain, but minor itch, within 36 hrs. - 40 hrs. 10/10/2008, swelling gone, slightly red, minor itch.									Y	10/07/2008	10/07/2008	0	None	OTH	OTH	Lisinopril; HCTZ	None	Hypertension			1						1	Erythema; Pruritus; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA171AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0328119	10/10/2008	OH	68.0	68		F	10/10/2008	Throat feels full, difficulty swallowing. Eye itchy. Treated with BENADRYL, SOLU-MEDROL, Prednisone.				Y					Y	10/09/2008	10/09/2008	0		PVT	PVT	Digoxin		Allergic to Sulfa and CIPRO; Osteopenia; Atrial Arryhthmia; Hyperlipidemia			1						1	Dysphagia; Eye pruritus; Throat tightness	FLU3~SANOFI PASTEUR~U2740AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328121	10/10/2008	IL		78		F	10/11/2008	Difficulty breathing 3:30 AM, 10/9/8. About 24 hrs. better now.									Y	10/08/2008	10/09/2008	1		OTH	OTH		Unknown	Unknown			1						1	Dyspnoea	FLU3~SANOFI PASTEUR~U2741AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~09630~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328123	10/10/2008	IA	72.0	72		M	10/10/2008	Pt. developed fever, muscle ache, pain and redness at site of injection. Reported fever, muscle ache evening of administration.				Y					U	10/08/2008	10/08/2008	0		OTH	OTH	VICODIN; PROAIR; GABAPENTIN					1						1	Injection site erythema; Injection site pain; Myalgia; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0962U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0328124	10/10/2008	TX	84.0	84		U		Injection site reaction - arm swelled, reddened, and had elevated temp. Patient became ill; returned to pharmacy 2 days after shot. She was recommended to see Dr - site was infected and treated with ABx.									Y	10/02/2008	10/03/2008	1	Culture - pending	OTH	PUB						1						1	Culture; Erythema; Injection site infection; Injection site reaction; Malaise; Oedema peripheral; Pyrexia	FLU3~SANOFI PASTEUR~U2742AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1381U~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328125	10/10/2008	CA	43.0	43		F	10/10/2008	I got the flu shot at 16:00 yesterday. By 19:00, I started feeling like I couldn't take a deep breath. It took alot of work to breath in and out. Each breath caused me to cough. At 20:30, I took BENADRYL, 50 mg, PO. This seemed to ease my symptoms and by 21:30, I fell asleep. This morning, I'm hoarse and still feel like my breathing isn't back to normal.									U	10/09/2008	10/09/2008	0	None	PVT	PVT	None	None	Pollen			1						1	Cough; Dysphonia; Dyspnoea	FLU3~SANOFI PASTEUR~U2740AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328126	10/10/2008	AK		70		F	10/10/2008	Early afternoon, the day after immunizations, pt. noted exquisite tenderness, warmth and redness and slight swelling on front of R arm, below armpit. deltoid area where injection given slightly tender. No redness, warmth or swelling. 10/10/08, no nodes palpable. No fever. Decreased tenderness, redness and swelling unchanged. To MD, unknown cause. Started client on antibiotics and BENADRYL @ HS.				Y					U	10/08/2008	10/09/2008	1		PUB	PUB		None	None			1						1	Erythema; Oedema peripheral; Skin warm; Tenderness	FLU3~SANOFI PASTEUR~U2807AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0554U~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0328127	10/10/2008	WI	79.0	79		F	10/10/2008	Patient given expired medication.									U	10/07/2008			None	PVT	PVT	FOSAMAX; TUMS; Chlorthalidone; Folic Acid; XYLZAL; ALAVERT; CLARITIN; NASONEX; Multiple Vitamins; Amoxicillin; Pravastatin;	None	NKA			1						1	Expired drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80682~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0328128	10/10/2008	WI	81.0	81		M	10/10/2008	Patient given expired medication.									U	10/07/2008			None	PVT	PVT	COREG; LASIX; Lisinopril; Multiple Vitamins; Potassium Chloride; Pravastatin; AZULFIDINE; COUMADIN; Carvedilol; Pravachol;	None	NKA			1						1	Expired drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80682~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0328129	10/10/2008	WI	73.0	73		F	10/10/2008	Patient given expired medication										10/07/2008			None	PVT	PVT	See attached		Beta blockers			1						1	Expired drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80682~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0328130	10/10/2008	WI	89.0	89		F	10/10/2008	Patient given expired medication										10/07/2008			none	PVT	PVT	See Attached	none				1						1	Expired drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80682~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0328131	10/10/2008	WI	78.0	78		F	10/10/2008	Patient given expired medications										10/07/2008			none	PVT	PVT	See attached	none				1						1	Expired drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80682~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0328132	10/10/2008	WI	93.0	93		F	10/10/2008	Patient given expired medication										10/07/2008			none	PVT	PVT	See attached	none	penicillin			1						1	Expired drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80682~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0328133	10/10/2008	FL				F	10/10/2008	24 hours after flu injection felt tingling in lower lip, eyes felt swollen and hurt, nose congested. Mid throat irritation. No wheezing went to urgent care received steroid injection									Y	10/07/2008	10/07/2008	0	Steroid Injection	OTH	UNK						1						1	Eye pain; Eye swelling; Nasal congestion; Paraesthesia oral; Throat irritation	FLU3~SANOFI PASTEUR~U2831AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328134	10/10/2008	TX	30.0	30		M	10/06/2008	Few hours after Adacel and flu shot -> severe myalgia, increased gas, diarrhea, decreased appetite dizziness, fever (100-101 degrees) -> Tylenol, Gas X, pepcid										10/03/2004	10/03/2004	0	T = 101 degrees at OV 10-4-08	PVT	PVT	None	None	None			1						1	Body temperature increased; Decreased appetite; Diarrhoea; Dizziness; Flatulence; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U2769AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C3027BA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0328145	10/10/2008	AZ	63.0	63		F	10/10/2008	Patient was new refugee here for physical/immunization.  After seeing doctor, patient had labs drawn/immunizations.  Patient showed signs of anxiety because she said she never had shot before.  Patient was taken into lobby and about 15 minutes she c/o nausea.  I was putting her into room to sit and she passed out on floor before breaking arm.									Y	10/09/2008	10/09/2008	0	Blood sugar/EKG	PVT	PUB			N/A; foreign refugee, no med hx			1						1	Anxiety; Blood glucose; Electrocardiogram; Loss of consciousness; Nausea; Pathological fracture	FLU3~SANOFI PASTEUR~U2756AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0866X~UNK~~RA~HEP B (RECOMBIVAX HB)~1|MMR~MERCK & CO. INC.~1011X~UNK~~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0177X~UNK~~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0328150	10/10/2008	TN	61.0	61		F	10/12/2008	Pt described severe swelling from injection site to elbow, redness and pain. Began nite of injection has resolved some when spoke with 3 days after									Y	10/06/2008	10/06/2008	0		OTH	OTH	KLORCON 10, EVISTA 100 mg, METOPROLOL ER 25 mg, LISINOPRIL - HCTZ 20/125	Hypertension, osteoporosis				1						1	Erythema; Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89971~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0991U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328151	10/10/2008	CO	27.0	27		M	10/10/2008	Soreness, red at site possibly 3cc dosage									U	10/08/2008	10/08/2008	0		OTH	UNK						1						1	Incorrect dose administered; Injection site erythema; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AELLA153AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0328153	10/10/2008	CT	57.0	57		F	10/10/2008	Redness. Swelling at injection site Flu like symptoms.				Y					U	10/08/2008	10/08/2008	0		OTH	UNK						1						1	Erythema; Influenza like illness; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA153BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0328155	10/10/2008	TX	65.0	65		M	10/09/2008	cellulitis - Dr's visit 10/08/08 at pneumonia injt site CEPHALEXIN				Y					N	10/07/2008	10/07/2008	0		UNK	PVT	None	None	None			1						1	Injection site cellulitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89750~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1383U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0328158	10/10/2008	TX	64.0	64		F	10/10/2008	cellulitis at pneumonia inj. site - Dr's visit 10/09/08				Y					N	10/07/2008	10/07/2008	0		OTH	PVT	None	None	None			1						1	Injection site cellulitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89750~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1383U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0328174	10/10/2008	KY	4.0	4		M	10/10/2008	Patient was seen on 10/7/08 for his 4 year well child exam at which time he received his vaccinations.  Returned to the office on 10/10/08 with cellulitis of the left thigh.										10/07/2008	10/10/2008	3	None	PVT	PVT	Patient on Zyrtec	None	None			1						1	Injection site cellulitis	DTAP~SANOFI PASTEUR~C2956AA~5~~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2786AA~2~~~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0836~4~~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1079X~2~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0972X~2~~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0328090	10/11/2008	OH	67.0	67		F	10/11/2008	patient developed severe pain in right arm at injection site of pneumovax. pain severe enough that not improved wth vicodin and unable to move arm d/t severe pain. pt states had some pain in right arm after injection. required ER visit				Y					Y	10/07/2008	10/08/2008	1		PUB	PVT		no	denies			1						1	Injected limb mobility decreased; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89750~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0989u~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0328091	10/11/2008	AZ	75.0	75		F	10/11/2008	6 hours post vaccination pt developed rash on lower extremeties and lower abdomen. small red like dots all over legs were described. Rash subsided over the next 7 days									Y	09/27/2008	09/27/2008	0	none performed	UNK	PVT	lisinopril 10mg daily	none	hypertension,nknda	none~ ()~NULL~~In Patient		1						1	Rash erythematous	FLU3~SANOFI PASTEUR~u2742aa~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328092	10/11/2008	WA	37.0	37		F	10/11/2008	Inadvertantly received Pneumonia vaccine as a Tb test indradermally.  Within 20 hours developed hot painful, swelling area around size of golfball on forearm that developed into cellulitis requiring hospitalization with IV antibiotics and dressing changes within 48 hours of vaccine administration.  Still on treatment ll days later and may require surgical debridement of site later next week.  10/21/08 Reviewed hospital medical records of 10/3-10/5/2008. FINAL DX: no d/c summary available.  H&P states LUE cellulitis s/p inadvertent SQ injection os pneumococcal vaccine, failed oral antibiotics Records reveal patient experienced immediate injection site redness, swelling & pain.  Had received pneumo vaccine via ID on 10/1/08.  RTC on 10/2 & tx w/oral antibiotics but condition worsened & developed chills & red streaks up the arm.  Exam revealed well demarcated large raised red area on volar aspect of left forearm w/central bullous formation, exquisite tenderness, red streaking up the arm to the axilla.  Tx w/IV antibiotics, pain meds & warm compresses.  ID consult done. Improved & d/c to home on continued antibiotics.					Y	4			U	10/01/2008	10/02/2008	1	LABS: CBC, CXR & UA WNL.  Blood c/s neg.	UNK	UNK		none	none			1						1	Incorrect route of drug administration; Injection site cellulitis; Injection site pain; Injection site swelling; Injection site warmth	FLU3~CSL LIMITED~02249111A~7+~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~UNKNOWN MANUFACTURER~unkown MD files~1~ID~LA~PNEUMO (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0328094	10/11/2008	SC	36.0	36		F	10/11/2008	15 to 30 minutes after influenza vaccine administration patient complained of a 'weird taste in mouth and a tight throat. Her BP and pulse were normal at 30 minutes and 45 respectively (120/68, pulse 72 and 116/80, pulse 74) with no evidence of bronchospasm, difficulty breathing, swelling of face/tongue or redness. She was given a 50mg oral dose of diphenhydramine since she did not meet protocol criteria for epinephrine administration at this time. Approximately 50 to 60 minutes after influenza vaccination, patient's  bp and pulse were beginning to rise (136/89 with pulse 93) and she began to experience palpitations, dizziness, sweating and itchy,red palms. At 6:48pm a 0.3mg EPi-pen was administered in right outer thigh by lead immunizer, and EMS was notified. EMS arrived at approx. 7pm and took over care and monitoring of patient. They administered oxygen and continued to monitor bp, pulse and checked cardiac rhythym. At no time did patient become unconscious, stop breathing or require CPR. Paramedics noted increased bp/pulse most likely due to epinephrine administration. EMS and lead immunizer advised patient to seek follow-up care and she was released by EMS at 7:30pm after signing a release that she refused to be taken to the hospital.									Y	10/09/2008	10/09/2008	0	Patient's only drug allergies includes NSAIDS (specifically Ibuprofen and diclofenac) with no allergy to eggs and a history of influenza vaccination for at least the last 2 years. She thought this was her 3rd or 4th year for vaccination.	UNK	UNK	none known	None noted, but patient complained of cold symptoms approximately 1 week prior to vaccination.	NSAID (ibuprofen, diclofenac)			1						1	Blood pressure increased; Dizziness; Dysgeusia; Erythema; Heart rate increased; Hyperhidrosis; Palmar erythema; Palpitations; Pruritus; Throat tightness	FLU3~SANOFI PASTEUR~U2754AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328095	10/11/2008	VA	1.5	1	.6	M	10/03/2008	On the 7th day, Nicolas developed a fever of 101 degrees.  It lasted for 4 days and got as hight as 103.5.  It finally subsided on the 4th day, then he developed a red prickly rash that covered is face, chest and neck.									N	10/03/2008	10/08/2008	5	Patient still has the rash.	PVT	PVT	None	None	None			1						1	Pyrexia; Rash erythematous	DTP~UNKNOWN MANUFACTURER~unknown~UNK~IM~LA~DTP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~unknown~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~unknown~2~IM~RA~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1	USA		Influenza
0328159	10/11/2008	VA	64.0	64		U		sore, swollen arm, 9 days after the ADACEL shot (left arm only)				Y					U	10/03/2008	10/11/2008	8		OTH	OTH	(METHOTREXATE)	No	Rheumatoid Arthritis			1						1	Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~UZ747AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2998BA~UNK~IM~UN~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0328097	10/12/2008	AZ	0.75	0	.8	F	10/12/2008	Baby fussy all day after receiving vaccine, started wheezing slightly in evening.  Baby awoke at 5:00am next morning with fever, 101.2.  Baby stripped, given Children's Tylenol and juice/water mix.  Slept additional hour.  Second Children's Tylenol given at 9:00am.  Fever subsided by 10:30am.									Y	10/08/2008	10/09/2008	1		PVT	UNK		NONE	NONE			1						1	Irritability; Pyrexia; Wheezing	FLUX~UNKNOWN MANUFACTURER~~1~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328102	10/12/2008	MO	30.0	30		F	10/12/2008	Growing Cellulitus at injection site while high fever, headache and flu-like symptoms, a day after vaccine. Symptoms progressively got worse and went to the E.R. with a temperature of 104. I am continuing to be seen and will have follow-up blood work. The cellulitis has grown and is very painful.				Y						10/09/2008	10/10/2008	1	Blood work done, more cultures to be taken on Oct. 13	PUB	PVT	tamoxifen, lisinopril, protonix	none	breast cancer, asthma, acid reflux	none~ ()~NULL~~In Patient		1						1	Blood test; Culture; Headache; Influenza like illness; Injection site cellulitis; Injection site pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~?~5~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~?~1~IM~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0328103	10/12/2008	ME	65.0	65		M	10/12/2008	local pain 24 hours post injection. Local redness 24 hours post injection. Increased redness and swelling deltoid/upper arm with worsening arm pain and swelling 60 hours post injection, limited to upper lateral arm. Myalgias/malaise 60 hours post injection. Treated with warm compresses, diphenhydramine, cephalexin to cover possible cellulitis				Y					U	10/09/2008	10/10/2008	1	None	PVT	PVT	anafranil, clonazepam,lipitor, Zoloft	None. Upper respiratory symptoms developed after injection, exposed to family member with same URI symptoms.	Obsessive-Compulsive disorder, hyperlipidemia			1						1	Erythema; Malaise; Myalgia; Oedema peripheral; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~XXXXX~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~09887~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0328104	10/12/2008	CO	9.0	9		F	10/12/2008	Large welt on leg--approximately 4 inches in diameter where shot was given.									U	10/09/2008	10/10/2008	1		PVT	PVT	none	none	none			1						1	Injection site urticaria	FLUX~UNKNOWN MANUFACTURER~~5~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0326179	10/13/2008	WI	5.0	5		M	10/10/2008	Information has been received from a physician (also reported to VAERS - temporary # E24922) concerning a 5 year old male who, on 24-SEP-2008 at 4:15 pm, was vaccinated with a second dose of MMR II (manufactured with rHA), (Lot # 660209/1119X), SC, right arm. Suspect therapy included a second dose of VARIVAX, (Lot # 661556/1002X), SC, left arm. Concomitant therapy included FLUMIST (MEDIMMUNE VACCINES, INC.) (Lot # 500545P), intranasal; a fifth dose of DAPTACEL (SANOFI PASTEUR), (Lot # C2956AA), IM, left arm; and a fourth dose of IPOL (SANOFI PASTEUR) (Lot # A0836), IM, right arm. On 24-SEP-2008 at 4:45 pm, 30 minutes after leaving the (physician's) office and after receiving immunizations at his well child check, the patient returned with his mother. At the time of his return, he was flushed with hives present; eyelids, tongue, and lips were swollen, the patient was having difficulty swallowing; and there was decreased responsiveness (eyes open but not talking). 911 was called. The patient was tachycardic upon exam by responsible physician with normal respiratory rates. An Epi-pen Jr. was administered to the patient's left thigh. Oxygen saturation was 96-98%. Paramedics arrived within 5 minutes and the patient was transported to the emergency room in stable condition for further evaluation and unspecified treatment. The patient recovered and was released. No product quality issues were involved. Upon internal review, the event of drug hypersensitivity was considered to be an other important medical event. No further information is available.				Y					Y	09/24/2008	09/24/2008	0	Pulse oximetry, 09/24/08, 96-; Total heartbeat count, 09/24/08, tachycardic; Respiratory rate, 09/24/08, normal	UNK	UNK			Unknown		WAES0809USA04413	1						2	Depressed level of consciousness; Dysphagia; Eyelid oedema; Flushing; Lip swelling; Oxygen saturation normal; Respiratory rate; Swollen tongue; Tachycardia; Urticaria; Drug hypersensitivity; Dysphagia; Eyelid oedema; Flushing; Hypokinesia; Lip swelling; Swollen tongue; Tachycardia; Urticaria; Depressed level of consciousness; Dysphagia; Eyelid oedema; Flushing; Lip swelling; Oxygen saturation normal; Respiratory rate; Swollen tongue; Tachycardia; Urticaria	DTAP~SANOFI PASTEUR~C2956AA~5~IM~LA~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500545P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~A0836~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1119X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1002X~2~SC~LA~VARICELLA (VARIVAX)~1|DTAP~SANOFI PASTEUR~C2956AA~5~IM~LA~DTAP (DAPTACEL)~2|FLUN3~MEDIMMUNE VACCINES, INC.~50054P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|IPV~SANOFI PASTEUR~A0836~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~2|MMR~MERCK & CO. INC.~1119X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~2|VARCEL~MERCK & CO. INC.~1002X~2~SC~LA~VARICELLA (VARIVAX)~2|DTAP~SANOFI PASTEUR~C2956AA~5~IM~LA~DTAP (DAPTACEL)~3|FLUN3~MEDIMMUNE VACCINES, INC.~500545P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3|IPV~SANOFI PASTEUR~A0836~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~3|MMR~MERCK & CO. INC.~1119X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~3|VARCEL~MERCK & CO. INC.~1002X~2~SC~LA~VARICELLA (VARIVAX)~3	USA	Emergency room visit	Influenza
0328253	10/13/2008		55.0	55		F	10/10/2008	Information has been received from a health professional concerning a 55 year old female who on 03-OCT-2008, in the afternoon, was vaccinated with a dose of PNEUMOVAX23 (Lot # 660718/0551X). Concomitant therapy included FLUVIRIN administered in the opposite arm. On 03-OCT-2008, later that night, the patient was admitted to the hospital with an infection of her arm that was vaccinated with PNEUMOVAX 23. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.					Y	0			N	10/03/2008	10/03/2008	0	Unknown	OTH	OTH			Unknown		WAES0810USA00802	1						1	Infection	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0551X~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0328259	10/13/2008	AZ	52.0	52		F	10/01/2008	Pt. received flu shot and site immediately began to swell. A lump formed at the site and increased. Pt. stated heart was racing, no shortness of breath. Neck became blotchy and red. 911 was called. Epi was given 1 dose at the site. Paramedics responded and took pt. to hospital.  2/2/09 MR received for ER visit 10/1/08 with DX:  Medication reaction. Pt developed local reaction, chest tightness and redness to neck and chest after receipt of Flu shot. Epipen given on scene after which pt became tachycardic at 160 BPM.  Chest tighness resolving on arrival to ER.  In sinus tach on arrival. Ice placed on hard area at injection site. Tx with Benadryl and D/C				Y					Y	10/01/2008	10/01/2008	0	Also allergic to Epinephrine	PUB	PVT	Allegra; Synthroid	None	Takes ALLEGRA has been off allergy shots for 5 years. Also allergic to Epinephrine.			1						1	Erythema; Immediate post-injection reaction; Injection site mass; Injection site swelling; Palpitations; Rash macular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA755AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0328260	10/13/2008	VA	56.0	56		M	10/02/2008	Guillain-Barre Syndrome Dx at hospital 7/13/07-Spinal Tap 6/25/08-Started falling down-Then became weaker loss of function of upper and lower extremities-Pain in arms and legs- TMT at hospital IVIG-5 tmts-Extensive Rehab. 10/28/08 Reviewed hospital medical records of 7/4-7/10/2007. FINAL DX: likely acute inflammatory demyelinating polyneuropathy. Records reveal patient experienced fatigue, anorexia & progressively ascending weakness x 10 days.  Recent UTI tx w/antibiotics.  Exam revealed areflexia throughout. Tx w/IVIG x 5 days.  Improved but still w/significant weakness & d/c to rehab facility.    10/31/08 Reviewed EMG/NCS report of 7/5/07 which states findings c/w primarily axonal motor sensory polyneuropathy with suggestion of mild conduction block that implies superimposed demyelinating component.  Diabetic neuropathy w/possible superimposed acute or subacute inflammatory process suspected.			Y	Y	Y	6	Y		Y	11/28/2006	06/25/2007	209	Spinal tap; Nerve cond. test; muscle test; Blink test; x-ray chest, abd.; EKG   LABS: LP.  EMG/NCS c/w GBS complicated by diabetic peripheral neuropathy.	PVT	PVT		DM-neuropathy, HTN	PMH: HTN, DM, s/p GSW to heart 1994 w/muscle graft, abdominal wound repair, chronic LE peripheral neuropathy.			1						1	Abdominal X-ray; Asthenia; Blood product transfusion; Chest X-ray; Electrocardiogram; Fall; Guillain-Barre syndrome; Lumbar puncture; Mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2248AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0328262	10/13/2008	MI	68.0	68		F	10/08/2008	Flu Vaccine was given with pneumoning without any problems. Noted, about 15min patient came and stated her back hurt. Blood pressure 150/80, Pulse-60 regular rhythm rate. No other signs and symptoms went shopping after.									Y	10/04/2008	10/04/2008	0		OTH	OTH	Unknown	Unknown	Unknown			1						1	Back pain	FLU3~SANOFI PASTEUR~62749AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0622X~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328264	10/13/2008	UT	11.0	11		F	10/06/2008	Redness, itching, pain, spot sore/hot to touch -(antibiotic course, BENADRYL) headache - redness at injection site as large as a baseball)				Y					Y	10/01/2008	10/01/2008	0		PVT	PVT	None	None	None			1						1	Injection site erythema; Pain; Pruritus; Skin warm	FLU3~SANOFI PASTEUR~U2763AA~5~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U261PAR~1~IM~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~UF452AA~1~IM~UN~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0328266	10/13/2008	CO				F	10/02/2008	Dizziness, headache, felt like something caught in throat, felt feverish, swollen eyes/shortness of breath.									Y	10/01/2008	10/01/2008	0	None	PVT	OTH	Ibuprofen	None	None			1						1	Dizziness; Dyspnoea; Eye swelling; Feeling hot; Headache; Throat irritation	FLU3~SANOFI PASTEUR~U2744AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328268	10/13/2008	NE	40.0	40		F	10/08/2008	Severe discomfort  from shoulder to elbow with minimal movement of entire Rt. arm. Symptoms started the evening of vaccines. 10/08/2008 hives started in arm.										10/06/2008	10/07/2008	1		PUB	UNK		None	None			1						1	Injected limb mobility decreased; Pain in extremity; Urticaria	FLU3~SANOFI PASTEUR~U2766AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~08040~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328270	10/13/2008	KY	62.0	62		M	11/08/2008	Fever 102.5- Pain, swelling, Erythema at site, Myalgia, fatigue.									U	10/06/2008	10/07/2008	1	None	PVT	PVT		None	Allergy to Aspirin			1						1	Fatigue; Injection site erythema; Injection site pain; Injection site swelling; Myalgia; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA173AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1960U~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328271	10/13/2008	PA	6.0	6		F	10/06/2008	6 cm x 6 cm area erythema, induration.									Y	10/05/2008	10/05/2008	0		PVT	PVT	Allegra; Veramist	None	Allergic Rhinitis			1						1	Erythema; Induration	FLU3~SANOFI PASTEUR~U27846A~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328274	10/13/2008	GA	51.0	51		F	10/03/2008	Patient received flu shot, returned approximately 20 minutes later with Complains Of scratchy throat and hoarse voice. Denies 5oB, itching ,or abdominal pain. Vital Signs Stable=blood pressure 149/115, P73, R16. Patient Benadryl  shot. Given 25mg  Intramusclar. Patient reports not taking home blood pressure medicine this morning, and having allergic reaction yesterday to a bee sting. Patient recovers after observation									Y	10/03/2008	10/03/2008	0		OTH	UNK						1						1	Dysphonia; Throat irritation	FLU3~CSL LIMITED~00849211A~2~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0328275	10/13/2008	MA	78.0	78		F	09/30/2008	Myalgias, low grade fever, cough, anorexia. Doxycycline 100 mg BID X 10 d									Y	09/19/2008	09/20/2008	1	Chest XR, CBC, Blood culture (-)	PVT	UNK	PAXIL, MIACALCIN, vitamin supplements.	None	Allergies, codeine, AUGMENTIN, FOSAMAX. Breast cancer, osteoporosis			1						1	Anorexia; Blood culture negative; Chest X-ray normal; Cough; Full blood count normal; Myalgia; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA179AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0328276	10/13/2008	KY	24.0	24		F	10/08/2008	On 10/2 it was warm and red.  Continues to be warm, red + very painful.  On 10/7 2 knots formed.									N	10/01/2008	10/02/2008	1		PUB	PVT	Birth control pill, ADEROL	No	No			1						1	Erythema; Nodule; Pain; Skin warm	FLU3~SANOFI PASTEUR~U2739AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2996AA~1~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0328277	10/13/2008	MA	71.0	71		M	10/03/2008	Received injections @ 5pm increased pain and red swollen, cramping at sites by 12am next day.									Y	10/01/2008	10/02/2008	1		PUB	PVT	Unknown	None	None			1						1	Injection site erythema; Injection site pain; Injection site swelling; Muscle spasms	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFUA191AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1132U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328278	10/13/2008	MA	69.0	69		F	10/02/2008	Upon leaving clinic pt could not raise or move her R arm. Red, warm swollen, stiff TYLENOL taken with zero relief pt states plus reaction from flu years ago.									Y	10/01/2008	10/01/2008	0		PUB	PUB	Unknown		Asthma	~Influenza (Seasonal) (no brand name)~UN~0.00~In Patient		1						1	Erythema; Injected limb mobility decreased; Musculoskeletal stiffness; Oedema peripheral; Similar reaction on previous exposure to drug; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFUA191AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0328279	10/13/2008	VA	54.0	54		F	10/18/2007	Patient  With Lower back pain 5-10 minutes after her vaccination, 911 was called, They checked the patient, vitals were all normal. Patient was transferred  to the  MCN.				Y					U	10/12/2007	10/12/2007	0	Unknown	OTH	OTH		None Known	Liver Disease, Diabetes			1						1	Back pain	FLU3~SANOFI PASTEUR~U2492AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328280	10/13/2008	IN	46.0	46		F	10/01/2008	10/01/2008 - at 1:30pm symptoms started:  chest tightness, pain from left clavicle to mid-sternum and in back.  Face was red.  Took 3- ADVIL, and worked entire shift to 7pm.  Took 3 more ADVIL at 9pm.  Thurs. 10/2 had headache across back of head, no fever, mild aching, didn't feel good  and actually drove out in front of another car.  Fri 10/3- no symptoms									Y	10/01/2008	10/01/2008	0	None	PUB	PUB	None	None	Drug Allergy to CODIENE and SULFA			1						1	Back pain; Chest discomfort; Chest pain; Erythema; Headache; Malaise; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA350CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0328281	10/13/2008	OR	2.0			M	10/01/2008	Seen 9/25 in clinic with rash.  Culture sent.  Positive Varicella (post vaccine 10/25/07).									Y				Positive Varicella Zoster virus DNA 9/25/08	PVT	PVT	None	None	None			1						1	Rash; Varicella post vaccine; Viral DNA test positive	DTAP~SANOFI PASTEUR~C2651AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2459MA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0749U~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1173U~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0328283	10/13/2008	GA	83.0	83		F	10/06/2008	Left arm redness, warmth extending from shoulder to elbow.									U	10/03/2008	10/03/2008	0		PVT	UNK		None	HTN, Hyperlipidemia, A-Fib, CVA, and Lymphoma			1						1	Erythema; Skin warm	FLU3~SANOFI PASTEUR~U2810AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0328284	10/13/2008	NE	38.0	38		F	10/08/2009	About 4:30pm - burning in her chest, hard to breathe, coughing a lot.  Outside taking daughter to dance.  Around 7pm - body ache, neck ache, headache.  8pm - took Ibuprofen.  Eyes red.  Temp 100.4.  No other treatment, slept and still has slight neck ache, body aches.  T-97.9 this morning.  Given Ibuprofen.									Y	08/07/2008	08/07/2008	0		PUB	PVT	Vitamin one a day women's; weekly allergy injections		Yes - molds, grasses, pollen, dust.  Receives weekly allergy shots.			1						1	Body temperature increased; Burning sensation; Cough; Dyspnoea; Headache; Neck pain; Ocular hyperaemia; Pain	FLU3~SANOFI PASTEUR~U2809AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328285	10/13/2008	MS	70.0	70		F	10/07/2008	Received injection 10/02/2008 that eve I had 100.4 temp, my arm had hard, swollen area.  That progressed to my elbow.  Range of motion was limited.  My arm by 10/3 was hot, red swollen & painful to the elbow.  Location Lf. Deltoid to elbow									Y	10/02/2008	10/02/2008	0	I treated myself with ice to the area and BENADRYL.	OTH	PUB	Take TOPROL, MAXIDE, PREMARIN, Calcium, SINGULAIR		Benign HTN, Allergies grasses, weeds, trees			1						1	Body temperature increased; Induration; Injected limb mobility decreased; Oedema peripheral; Pain in extremity; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~0988F~2~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~AFLUA380AA~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328287	10/13/2008	FL	69.0	69		M	10/07/2008	Day after flu shot, patient got sore throat, muscle aches and chills.  Arm where injection given was sore.  Had headache.									Y	10/02/2008	10/03/2008	1		PVT	PVT		None				1						1	Chills; Headache; Injection site pain; Myalgia; Pharyngolaryngeal pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0328320	10/13/2008	LA	33.0	33		F	10/13/2008	Flu shot received approx 3pm on 10/8/08. Approx 10 pm, awakened with severe chills, temperature spike to 103 F. Severe headache, general malaise. In bed for two days before experiencing relief. Tylenol by mouth for treatment.									Y	10/08/2008	10/08/2008	0	none	PUB	UNK		none	PCN, hyperlipidemia			1						1	Activities of daily living impaired; Body temperature increased; Chills; Headache; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328321	10/13/2008	TX	29.0	29		F	10/13/2008	Approx 20 minutes after receiving vaccine pt felt the injection site was warm.  Pt came back to the Clinic and upon exam the injection site was red and was warm to the touch.  A 2 inch rash surrounded the injection site and the pt was breaking out in a rash down both arms and on her back.   RN WHNP gave the pt one Diphenhydramine HCI 50mg with a glass of water.  Pt remained at the clinic for approx 30 minutes at which time she stated she felt better and the injection site was not as warm.  Pt left the clinic to go home.  She was instructed to call her OB/GYN due to the pt being 35 weeks pregnant.  Pt was also instructed to take an additional Diphenhydramine HCI at bedtime.									Y	10/10/2008	10/10/2008	0		UNK	UNK	Unknown	None	Unknown			1						1	Injection site erythema; Injection site rash; Injection site warmth; Rash	FLU3~SANOFI PASTEUR~U2757AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328324	10/13/2008	PA	31.0	31		F	10/13/2008	Within an hour of receiving the vaccine I developed a 2.5 inch welt at the injection site. Area was raised and itchy. After a week it isn't raised but is still red & itchy.									U	10/07/2008	10/07/2008	0		PVT	UNK	none	none	none			1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Injection site urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328326	10/13/2008	CA	48.0	48		F	10/13/2008	Employee has reddened, swollen area on L deltoid that is warm to touch (approximately 3 x 2 inch reddened area).  No fever, c/o soreness, burning, slight pain										10/09/2008	10/10/2008	1		PUB	PVT	synthroid daily	No	No, except hypothyroidism			1						1	Burning sensation; Erythema; Oedema peripheral; Pain; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88634~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0328327	10/13/2008	NV	76.0	76		M	10/13/2008	influenza & pnemovax given SQ L upper arm, 24hrs later felt sick, fatigued. Increased redness at site of SQ inj. C/o bad taste in mouth, pain 10/10				Y					U	10/06/2008	10/08/2008	2		PVT	PVT	ASA, Spirva, Asmanex, Simvastatin, vitamins	denied via questionnaire	Chronic back pain, COPD, CAD, Nocturia, mild Aortic Stenosis, Dyslipidemia, Renal insufficency, Gout			1						1	Dysgeusia; Fatigue; Injection site erythema; Malaise; Pain	FLU3~SANOFI PASTEUR~U2758AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0038u~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0328331	10/13/2008	PA	45.0	45		F	10/13/2008	Influenza vaccine administered at health fair at 9:45am,at 2:00pm developed swelling of eyelids,tightness in chest,cough.Benadryl 25mg po given coughing increased.Epinephrine 0.2ml given EMS called. Transported to ED.				Y					Y	10/10/2008	10/10/2008	0	None	UNK	UNK	LisinoprilHCTZ	NO	no			1						1	Chest discomfort; Cough; Eye swelling	FLU3~SANOFI PASTEUR~U2762AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328332	10/13/2008	IL	73.0	73		F	10/11/2008	Patient complained of minor swelling and warmth in her left arm and some pain that radiated down to her elbow. This was reported at around 6 hours after the vaccine was administered. Told the patient that she could put some cold compresses over her arm and to take a benadryl to help reduce the swelling and motrin for the pain. If the swelling did not og down or was getting worse then she should go to the ER. Called patient on 10/12 at around 1 pm to check up on her and she was doing well. Patient said she went to the ER just in case the previous evening. physician gave her darvocet for the pain and that was all.				Y					Y	10/11/2008	10/11/2008	0		UNK	UNK	n/a	n/a	n/a			1						1	Oedema peripheral; Pain in extremity; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89966~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0551x~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0328334	10/13/2008	WI	45.0	45		M	10/13/2008	Patient received pneumovax and influenza vaccine on 10-10-08.  Woke with fever, bodyaches, chills, swelling in L upper extremity on 10-11-08.  Developed cellulitis in L upper extremity.  10/31/08 Reviewed hospital medical records of 10/13-10/17/2008. FINAL DX: pneumonia, LUE injection site cellulitis Records reveal patient experienced fever, malaise, chills, fatigue, weakness, HA, reduced oral intake, left injection site cellulitis, pain, redness & warmth.  Tx w/IV antibiotics, improved & d/c to home on continued oral antibiotics & pain meds.				Y	Y	4				10/10/2008	10/11/2008	1	Chest xray on 10-11-08 and 10-13-08, CBC on 10-11-08 and 10-13-08.  Also had CMP, Sed rate, and blood culture on 10-11-08.  LABS: WBC 20.7(H), CXR abnormal w/perihilar infiltrations.  ESR 57(H).  Electrolyte imbalance.  Blood c/s neg.  CXR abnormal.	UNK	UNK	Percocet 5/325mg 1 every 6 hours as need.  Tramadol 50mg 1 tablet every 6 hours as needed.  Paroxetine 20mg 1 daily	None	Depression, Polyarthralgia, and Fibromyalgia.  PMH: pneumonia x 2.  Allergy: cyclobenzarine & duloxetine.			1						1	Chills; Full blood count; Metabolic function test; Oedema peripheral; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2797BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1538U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0328335	10/13/2008	KY	62.0	62		F	10/13/2008	PT REPORTED A THROBBING PAIN IN HER LEFT ARM THAT HAS NOT GOTTEN ANY BETTER.									Y	10/08/2008	10/08/2008	0		UNK	PVT						1						1	Pain; Pain in extremity	FLU3~CSL LIMITED~02349111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0328337	10/13/2008	TX	88.0	88		F	10/13/2008	Within hours of the vaccine noted bruising and area has fever, but with no induration or swelling noted.  Patient states that her arm is sore, but has good ROM									U	10/08/2008	10/08/2008	0	None	PVT	UNK	UNKNOWN	NONE				1						1	Contusion; Pain in extremity; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA366BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0328340	10/13/2008	OH	45.0	45		F	10/13/2008	Received Flu Vaccine on 10/7/08, began noticing at the injection site an area of warmth and reddness on 10/10/08.  On 10/11/08 the injection site was a large red area and very warm to the touch.  A noticable rash was on the right arm too.  On Sunday the rash had spread to both arms and neck.  On Monday, 10/13/08 the rash spread to both arms, neck, face, chest, back and legs.  The rash was raised in nature and red, some areas measured 7mm to 10mm.  I also received a TB test at the same time, on Friday the TB test was read as negative, now the area is raised and red.									U	10/07/2008	10/10/2008	3		MIL	UNK	Arava 20 mg 5x a week; Remicade infusions had 1 infusion on 9/28/08	Rheumatoid Arthritis	na			1						1	Injection site erythema; Injection site rash; Injection site swelling; Injection site warmth; Rash generalised	FLUX~UNKNOWN MANUFACTURER~~1~SC~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328341	10/13/2008	WA	79.0	79		F	10/13/2008	The morning following administration patient woke with an extremely sore arm.  I saw her that afternoon.  Arm was not red at administration site, however bright red, swollen and hot starting approx one inch below injection site all the way down to elbow at the inside of the arm.				Y					Y	10/09/2008	10/10/2008	1		UNK	PVT						1						1	Erythema; Oedema peripheral; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~u2802aa~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1226u~3~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0328342	10/13/2008	VA	61.0	61		F	10/13/2008	24 hours after shot, worse flu symptoms I've ever had.  Lasted about 24 hours. Chills, aches, up to at least a 102.5 fever, nausea, dizziness. But the most adverse is that after the worse of the flu symptoms passed, then the shot site inflamed, swelled, hurt, ached horribly. Felt hard and like a vise was wrapped around my arm.  Inflamed area is about a 5 oval with shot site centered near top.  Swelling and hardness is more around the site itself.  5 days later it still hurts, still swelled but down some, still aches, still itches, less red but still red.  Note:  I also got flu shot the same day in other arm.  No reaction there.				Y					U	10/08/2008	10/09/2008	1	Per PCP, don't get another one.  Per health system, most likely either a reaction to the Antigen or site of shot got infected at time of shot (eg., staph).  They advised that if it does not continue to get better, go see PCP again.	UNK	UNK	Boniva, Lunesta, Xalatan, Calcium, Glucosime, Daily Vitamin	No	ERYTHROMYCIN - Liver Inflamed after using it many many years ago.			1						1	Chills; Dizziness; Influenza; Injection site induration; Injection site inflammation; Injection site pain; Injection site pruritus; Injection site swelling; Nausea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U22828AA~2~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0988F~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0328344	10/13/2008	HI	11.0	11		M	10/13/2008	Varivax given in left arm, has large red, hot area below where the needle mark from shot was.  Seen in ED 101208, put on Clindamycin po.  Mom only gave one dose.				Y						10/10/2008	10/12/2008	2		PUB	PUB	none	none	none known			1						1	Injection site erythema; Injection site warmth	FLUN3~MEDIMMUNE VACCINES, INC.~50058p~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~1654U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0328346	10/13/2008	IL	37.0	37		F	10/13/2008	Right upper arm abscess. Vaccine was administerd about 2 weeks prior to admission to hospital on 10/12/2008. Patient experienced fever, chills, runny nose, cough, decreased appetite, nausea, vomiting. 10/14/08-records received for DOS 10/12-10/13/08-DC DX: Right arm abscess. Presented to ED with right upper arm abscess after receiving flu shot in same area 2 weeks ago. One week ago noticed redness and swelling at site progressed to erythematous abscess.  C/O flu-like symptoms for past week, low grade fever, chills, runny nose, clear sputum, flushing, decreased appetite. Abscess I & D.					Y	1			U	10/01/2008	10/01/2008	0		UNK	UNK			10/14/08-records received-PMH:Has had an abscess before. HIV, HCV and schizophrenia. Alcohol abuse. Smoker. Cocaine and heroin use.			1						1	Abscess limb; Chills; Cough; Decreased appetite; Nausea; Pyrexia; Rhinorrhoea; Vomiting	FLUX~UNKNOWN MANUFACTURER~unknown~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0328347	10/13/2008	PA	21.0	21		M	10/13/2008	Patient experienced a fever of 102.8 degrees approximately 7 hours after the injection.  Patient also experienced shaking chills after the fever subsided.  Patient took Ibuprofen as treatment.									Y	10/12/2008	10/12/2008	0		PUB	UNK	Albuterol inhaler, Ibuprofen	infected tooth in need of root canal	asthma			1						1	Chills; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U2807AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328349	10/13/2008	WA	58.0	58		F	10/13/2008	Sudden onset approximately one hour after injection; shortness or breath.  12/2/08 Reviewed hospital medica records of 10/9-10/10/2008. FINAL DX: SOB w/emphysema Records consist of labs & only partial d/c notes but hospital medical records states this is all that is available.					Y	1			Y	10/09/2008	10/09/2008	0	Hospital report is pending.  LABS: CXR abnormal w/stable emphysematous changes.  UA abnormal w/moderate leuk esterase, WBC 6-10.  Urine c/s neg.  WBC 6.0, H/H 15.6/48.4(H), polys 82%(H), lymphs 17%(L).  Chemistry WNL.	UNK	UNK	albuterol, Spiriva, Celebrex, Prilosec, Fosamax, Remeron, Trazodone	None	COPD, anxiety, depression, smoker, osteoporosis			1						1	Dyspnoea	FLU3~SANOFI PASTEUR~U2746AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0990U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0328350	10/13/2008	NJ	2.0	2	.9	M	10/13/2008	Following morning, after vaccination, child had very slight fever, complained of soreness and not feeling good. Given Motrin.  Following day, slight fever again, givven motrin.  Day care facility called to have child removed near end of day with 102.2 fever.  Fever dropped to 100.5 after Motrin, then continued on for about one more day.  Vistied doctor, said fever from vaccine was impossible, or a least extremely unlikely.				Y					Y	10/09/2008	10/10/2008	1		PVT	PVT	none	none	none			1						1	Malaise; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~~HEP A (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0328352	10/13/2008	WA	66.0	66		F	10/13/2008	Patient experience wheezing, throat tightning and red eyes that night. Next day she had a swollen pink eye, headache. Second day she noticed some swelling her arm and streaks along ehr sholder and under arm. Patient reported of having a fever. Patient states she started taking benadryl on the first day.									Y	10/02/2008	10/02/2008	0		PVT	PUB	PREMARIN	NONE	OSTEOARTHRITIS KNEE PAIN			1						1	Eye swelling; Headache; Injection site streaking; Ocular hyperaemia; Oedema peripheral; Pyrexia; Throat tightness; Wheezing	FLU3~SANOFI PASTEUR~U2745AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0813X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328353	10/13/2008	NH	72.0	72		F	10/13/2008	Commencing approx. 3-4 hrs. after injection, I was experiencing some discomfort from my left shoulder across my chest and into my back. Hard to describe the symptoms. As time went on it became more intense, and oppresive. The pain/aching was from my breasts up to my neck. Felt confused, developed chills to the extent I had to go to bed. This was around 11:15 PM. I literally was shaking.  I took 2 Tylenol 650 Mg. tablets.  They helped a little with the discomfort, but not the shaking and shivering.  The symptoms continued all night, could not sleep, was up and down and felt I was shutting down. By 4 AM the sypmtoms seemed to be easing up, coming and going. Took 2 more Tylenol.After 7 am I fell asleep and slept until 11:15 AM. I have been getting flu shots for the past 11 years since I had quadruple by-pass and have never had a reaction. Have no idea if this was the shot or what....I felt pretty good, but extremely tired all day Sat.,I sent the original letter before I forgot half the symptoms...had trouble breathing, had to keep taking deep breaths, no pain in my lungs, just that overall aching and fatigue in the areas I described....I live alone and in the cold light of day, I should have called 911 or someone...That is how confused I was...kind of spaced out. Over-all feel I am in pretty good shape. I still work 11 hours a week. I don't think I will ever get the flu shot again...even though we will probably never know if this was the cause, or just a bug of some sort.									Y	10/10/2008	10/10/2008	0	N/A	UNK	UNK	Toprol XL, prinivil, wellbutrin,hydrochlorot,Lipitor,Vitam D,Fish Oil. Tylenol Arthritis tablets, otc/sinus,otc acid reducer	Felt fine..........	Heart, artherosclerosis, pre-diabetic, High Cholesterol, triglicerides, actinic keretosis...old age....	NA~Pneumo (Pnu-Imune)~~0.00~In Patient		1						1	Chills; Confusional state; Discomfort; Dyspnoea; Fatigue; Insomnia; Pain; Tremor	FLU3~SANOFI PASTEUR~u2847AA /4284AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328354	10/13/2008	CO	58.0	58		F	10/13/2008	Abrupt onset whole body myalgia, chills day following vaccine, persisting 5 dys; dyspnea on exertion for 1 day beginning 4th day post-vaccination, responsive to inhaled albuterol									Y	10/08/2008	10/09/2008	1	NA	UNK	PVT	pravastatin, allopurinol	no	asthma, paroxysmal tachycardia, dyslipidemia, gout			1						1	Chills; Dyspnoea exertional; Myalgia	FLU3~SANOFI PASTEUR~u2741aa~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328360	10/13/2008	CO	49.0			F	10/13/2008	This case was reported by a healthcare professional and described the occurrence of asthmatic attack in a 49-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included asthma. On 7 October 2008 at 17:30 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. Immediately after vaccination with FLULAVAL, the subject developed redness and swelling and five minutes later, hyperventilation. It became difficult for her to breath and an asthmatic attack was reported along with anxiety. The subject was treated with Epi pen. Her oxygen level and pulse were normal in the office. The paramedics were called and the subject was transported to the emergency department where she was evaluated and released. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved. The reporter felt that the subject experienced an anxiety attack. Events of redness, swelling, hyperventilation and asthma attack were considered by the reporter, probably related to treatment with FLULAVAL.				Y					Y	10/07/2008	10/07/2008	0	The subjects oxygen level and pulse were normal in the office.	PVT	PVT		Asthma	The subject has received flu vaccine previously with no reactions reported.  There is no history of adverse events following any previous vaccinations.		A0751399A	1						1	Anxiety; Asthma; Dyspnoea; Erythema; Hyperventilation; Immediate post-injection reaction; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA185AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0328364	10/13/2008	TN	2.0	2	.0	F	10/13/2008	Received call from ER on 10/8/08 that patient admitted in ER (L) arm of cellulitis. Pt. received flu shot only on (L) arm. Rest of info. can be obtained from lab work.  12/8/08-records received for DOS 10/10-10/12/08-DC DX-left arm cellulitis. Presented with 2 day history of worsening cellulitis in left arm. Day after vaccination crying, left arm swollen with erythema. Vesciles appeared on day of admission with one large vesicle rupturing the day of admssion.				Y	Y	2				10/08/2008	10/10/2008	2		PUB	PUB			None			1						1	Injection site cellulitis	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B149AA~UNK~IM~RA~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2770AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB247AA~2~IM~RA~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0908X~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0997X~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0328365	10/13/2008	TN	37.0	37		F		Red, slightly swollen at site of injection, occurring approximately 18 hours of injection.  24-30 hour slight itch.  Disappeared in 42 hours.									Y	10/07/2008	10/08/2008	1	No	PVT	OTH			High blood pressure			1						1	Injection site erythema; Injection site pruritus; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA17AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0328368	10/13/2008	OH	39.0	39		F	10/13/2008	Swelling, fever, chills, vomiting, diarrhea 2 days-3days post.  site infected per ER MD- got antibiotics				Y					Y	10/07/2008	10/09/2008	2	Urine	OTH	OTH	ALBUTEROL	No	PCN, DARVOCET, Caffeine, Asthma			1						1	Chills; Diarrhoea; Injection site infection; Pyrexia; Swelling; Vomiting	FLU3~SANOFI PASTEUR~V2807AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328370	10/13/2008	IL	12.0	12		M	10/13/2008	Vaccines given as instructed by MD followed by lead test at mom's request. After lead test completed and bandaid applied pt c/o dizziness and light headedness and nausea. Emesis x1. Episode resolved after approx 30-40 min.									Y	10/13/2008	10/13/2008	0	POX 98%, HR 786 bpm	PVT	PVT						1						1	Dizziness; Nausea; Vomiting; Injection site erythema; Injection site pain; Injection site swelling; Pain	FLUN3~MEDIMMUNE VACCINES, INC.~500545P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U2618AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2767AA~6~IM~RA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1140X~2~SC~RA~VARICELLA (VARIVAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500548P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~4|MNQ~SANOFI PASTEUR~U2618A~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~4|TDAP~SANOFI PASTEUR~C2767A~1~IM~RA~TDAP (ADACEL)~4|VARCEL~MERCK & CO. INC.~1140X~2~SC~RA~VARICELLA (VARIVAX)~4	USA		Influenza
0328371	10/13/2008	CA	51.0	51		F	10/13/2008	Cellulitis as Diagnosed by Medical Doctor Still under treatment.				Y					U	10/10/2008	10/11/2008	1		OTH	PVT		NONE				1						1	Cellulitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~05540~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0328373	10/13/2008	TN	87.0	87		F	10/13/2008	Patient called morning of 10-7-08 complaining of pain and numbness in left arm.  Patient states pin started that afternoon after she received shot.  Pt called doctor who instructed her to take BENADRYL and DARVOCET for pain.  Patient stated she saw physician who gave her a shot for pain and pain  was relieved				Y					Y	10/06/2008	10/06/2008	0		OTH	UNK		No	No			1						1	Hypoaesthesia; Pain in extremity	FLU3~SANOFI PASTEUR~0554U~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~89971~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0328374	10/13/2008	MI	65.0	65		M	10/13/2008	Husband stated that wife had extreme shoulder pain where shot was given when she woke up Sat morning 10-4-08. Took MOTRIN helped some									U	10/03/2008	10/04/2008	1		OTH	UNK						1						1	Injection site pain; Musculoskeletal pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0328375	10/13/2008	ID	1.1	1	.1	F	10/07/2008	fever x 2 days-up to 104 deg, decreased appetite, chest congestion									U	09/26/2008	10/02/2008	6		PVT	PUB		chest congestion per mom				1						1	Decreased appetite; Pyrexia; Respiratory tract congestion	FLU3~SANOFI PASTEUR~UT2786BA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1926U~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C45152~UNK~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0951X~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0328376	10/13/2008	OH	50.0	50		F	10/13/2008	Vaccine administered on 10/7/08.  Allergic RTN started 10/9/08 with hives on arms, neck, trunk of body, progessed on 10/10 to swollen face , eye and troat.  Patient was referred to urgent care/ER  MD.				Y					U	10/07/2008	10/09/2008	2		OTH	OTH						1						1	Eye swelling; Hypersensitivity; Pharyngeal oedema; Swelling face; Urticaria	FLU3~SANOFI PASTEUR~U2754AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328377	10/13/2008	IN	7.0	7		M	10/13/2008	Generalized seizure with fever on Oct 8, 2008.				Y					Y	10/07/2008	10/08/2008	1	EEG pending; CT normal; CBC and Lytes, Glucose all normal	PVT	PVT		Febrile viral illness	None			1						1	Blood glucose normal; Computerised tomogram normal; Convulsion; Electroencephalogram; Full blood count normal; Laboratory test normal; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500555P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0328378	10/13/2008	OR	77.0	77		F	10/13/2008	Two hours after didn't feel good, felt extremely tired. Had chest pain, breathing problems. Nurse line recommended to call ambulance. Ambulance took vital and were OK after severe diarrhea began, hiccups, horrible gas. At 7 P.M. vomiting attacks started, gagging. Problems continued until Monday 7th by 10/9 and 10/10 felt better. Completely recovered by Saturday !!										10/04/2008	10/04/2008	0		UNK	PUB	LIPITOR, SINGULAIR, LISINOPRIL, ASMANEX, pantoprazole, NASONEX, albuterol sulfate, ibuprophen, garlic extract, Vitamin C, Vito flavins.	None	Asthma, fibroids, seasonal allergies, high cholesterol, acid reflux, arthritis			1						1	Chest pain; Diarrhoea; Dyspnoea; Fatigue; Flatulence; Hiccups; Malaise; Retching; Vomiting	FLU3~SANOFI PASTEUR~U2795AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328379	10/13/2008	CA	3.0	3		F	10/13/2008	Left leg 5X5  Redness and hot. Patient was given benedryl and Bactrim									U	10/10/2008	10/11/2008	1	None	PVT	OTH		Physical Exam				1						1	Injection site erythema; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88806~1~UN~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARCEL~MERCK & CO. INC.~1136X~2~UN~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0328380	10/13/2008	IL	65.0	65		M	10/10/2008	Malaise, Body Aches, weakness, tiredness.  Over all flu-like Sx without fever.  Chills feel as if Hit by a Truck									Y	10/01/2008	10/03/2008	2		OTH	OTH	None	None				1						1	Asthenia; Chills; Fatigue; Influenza like illness; Malaise; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~09881~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0551X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328381	10/13/2008	IL	69.0	69		F	10/10/2008	Malaise, achy body, weakness, tiredness. Overall flu-like Sx, without fever. Chill, feels as it Hit by a truck									Y	10/01/2008	10/03/2008	2		OTH	OTH	Citalopram	None				1						1	Asthenia; Chills; Fatigue; Influenza like illness; Malaise; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0551X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328382	10/13/2008	KY	85.0	85		M	10/10/2008	Rash to lower part of abdomen & groin + L wrist.  c/o severe itching overnight + this AM No Redness or swelling at injection site.				Y					Y	10/09/2008	10/09/2008	0		PUB	PUB	Unknown	None	Allergy- Peanuts			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U2802AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328388	10/13/2008	FL	5.0	5		M	10/14/2008	Right arm swelling from shoulder to just above elbow.									Y	10/09/2008	10/10/2008	1		PVT	OTH	None	None	None			1						1	Oedema peripheral	FLU3~SANOFI PASTEUR~U27030A~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328402	10/14/2008	TN	3.0	3		M	09/26/2008	Flumist nasal vaccine administered.  Pt. had an allergic reaction - allergic conjunctivitis.  10/21/08 Reviewed PCP office notes of 8/13 & 9/26/08. FINAL DX: none provided Records reveal patient experienced fever, HA decreased appetite, irritability, runny nose, tonsils enlarged & red on 8/13.  Dx w/pharyngitis & HA.  When RTC on 9/26, was doing well when flumist given.  No further records available.									U	09/26/2008	09/26/2008	0	Strep test & x-ray of sinuses neg.	UNK	UNK			Allergic rhinitis			1						1	Conjunctivitis allergic; Hypersensitivity	FLUN3~MEDIMMUNE VACCINES, INC.~500549P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0328404	10/14/2008	ID	57.0			F	10/08/2008	Patient came into clinic on 10/2 for flu shot and after getting home that evening began feeling flu-like and came back into emergency room with fever, chills and myalgias. Patient was re-hydrated with fluids and give PO TYLENOL.									Y	10/02/2008	10/03/2008	1		UNK	UNK	Acetaminophen dose: 650 units: MG Freq: QID Route: PO					1						1	Chills; Dehydration; Influenza like illness; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~AFLLA184AA~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328406	10/14/2008	MA	0.2	0	.2	M	10/11/2008	Parent was notified by phone - waited in the office for 20 minutes. Pt was in for a  well child visit and father asked for flu shot. Nurse gave flu vaccine to the 2 months old patient. Pt waited in office for 20 minutes no noted reaction. Went back to notify patient, and they need left office.									Y	10/10/2008	10/10/2008	0		PVT	PUB	None	None				1						1	Inappropriate schedule of drug administration	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~aC21B167a~1~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2783FA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF495aa~1~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C97890~1~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~04144~1~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0328407	10/14/2008	CT	74.0	73		F	10/06/2008	7 Hours after receiving vaccine patient developed chills, T101 , sweats and hives on both arms and head . Took benedryl, saw Medical Doctor  48hours later.									Y	09/28/2008	09/28/2008	0		UNK	UNK		No	Thyroid Condition- Severe Clam Allergy	13 years ago after having flu vaccine~Influenza (Seasonal) (Fluzone)~UN~13.00~In Patient		1						1	Body temperature increased; Chills; Hyperhidrosis; Urticaria	FLU3~SANOFI PASTEUR~U2751AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328408	10/14/2008	CA	3.0	3		M	10/09/2008	Right arm Cellulitis				Y					Y	09/30/2008	10/02/2008	2		PVT	UNK			History of gastroschisis and obesity			1						1	Cellulitis	DTAP~SANOFI PASTEUR~02958BA~4~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~V2805AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB246M~2~IM~LA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0328409	10/14/2008	TX	58.0	58		F	10/09/2008	At 4 PM  Pt. came back to pharmacy said she was experiencing redness of eyes, burning sensation in nose, coughing, and hot feeling in face.									U	10/09/2008	10/09/2008	0		OTH	PUB		None	PCN			1						1	Burning sensation; Cough; Feeling hot; Ocular hyperaemia	FLU3~SANOFI PASTEUR~U2741AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328410	10/14/2008	MA	36.0	36		F	10/09/2008	2 hours after flu-shot - left deltoid - c/o itching skin, no fever, no oral c/o.										10/09/2008	10/09/2008	0		PVT	PVT	No meds	No	No			1						1	Pruritus	FLU3~SANOFI PASTEUR~U2798EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328411	10/14/2008	ME	12.0	12		M	10/08/2008	Patient came in 24 hours later, area was puffy, redness the size of a 1/2 dollar.  Warm to the touch.  Tender around area.				Y					U	10/08/2008	10/08/2008	0		PVT	UNK		None				1						1	Erythema; Skin warm; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U2828AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328415	10/14/2008	TX	19.0	19		F	10/14/2008	Pt became pale, light headed and nauseas after administration. Event reported to Provider - B/P and finger glucose obtained. After lying down for aprrox 5-10 mionutes, S/s disapeared and Pt stated that she felt fine. No treatment given									Y	10/14/2008	10/14/2008	0	Orthostatic BP - Lying 90/64 pulse 74, Sitting- 88/67 pulse 63, Standing 94/73 pulse 74. 5-1- min later 96/69 pule 66 - BP WNL for Pt.	PUB	PUB	none	none	none			1						1	Blood pressure normal; Dizziness; Heart rate normal; Nausea; Pallor	FLU3~SANOFI PASTEUR~u2768aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0843x~3~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0328416	10/14/2008	NC	26.0	25		F	10/14/2008	was given influenza vaccine and developed 15mm multiple blisters to right deltoid. No treatment needed. No other signs or symptoms.									Y	09/29/2008	09/29/2008	0	N/A	PUB	PVT	N/A	N/A	N/A			1						1	Blister	FLU3~SANOFI PASTEUR~U2757AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328420	10/14/2008	MI	45.0	45		F	10/14/2008	developed chest congestion, cough, elevated temp and heart rate, palpations.  antihistimine prescribed and send home from work.				Y					Y	10/13/2008	10/13/2008	0	none	PUB	UNK		none	none			1						1	Activities of daily living impaired; Body temperature increased; Cough; Heart rate increased; Palpitations; Upper respiratory tract congestion	FLU3~SANOFI PASTEUR~U2757AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328421	10/14/2008	TN	74.0	74		F	10/14/2008	approx. 15 minutes after Flulaval administration, pt. began to vomit (three times in small amounts). no other signs/symptoms after vaccination. between time of vaccine admin. and adverse event, the pt. reported not eating breakfast and complained of stomach discomfort and decided to have a snack at the flu shot clinic.									Y	10/09/2008	10/09/2008	0	none	UNK	PUB	none recorded at our pharmacy	DM type II	none reported			1						1	Stomach discomfort; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA156AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0328422	10/14/2008	TX	8.0	9		F	10/14/2008	HIGH FEVER (1O3 DEGREES); NAUSEA; VOMITING; CHILLS; ACHES; FATIGUE; SHAKING.  SYMPTOMS STARTED THE EVENING OF THE VACCINATION AND CONTINUED SEVERAL DAYS.  PATIENT IS STILL RUNNING FEVER (100.2) AND VOMITING 5 DAYS LATER ALTHOUGH SHE IS FEELING SOMEWHAT BETTER									U	10/09/2008	10/09/2008	0		UNK	PUB		NONE THAT I AM AWARE OF	NONE THAT I AM AWARE OF			1						1	Chills; Fatigue; Nausea; Pain; Pyrexia; Tremor; Vomiting	FLU3~SANOFI PASTEUR~U2790BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328426	10/14/2008	CA	24.0	24		F	10/14/2008	09:08 received the following vaccines: HEPATITIS A MERCK 0020U 1.0CC IM RA, HEPATITIS B GSC AHBVB596CA 1.0CC IM LA, TYPHOID VI SANOFI A0923 0.5CC IM LA, FLULAVAL GSC AFFL197AA 0.5CC IM RA.  PT COMPLAINED OF DIZZINESS AND BLACKED OUT FOR APPX 15 SECONDS BEFORE BECOMING A+OX3.  PT GIVEN IV, BENADRYL AND PHENARGEN IN ACUTE CARE AREA AS A PRECAUTION.  NO FURTHER S/S.									Y	10/14/2008	10/14/2008	0		MIL	MIL	NONE	NONE	NONE/NKDA			1						1	Dizziness; Loss of consciousness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFL197AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB596CA~3~IM~RA~HEP B (ENGERIX-B)~1|HEPA~MERCK & CO. INC.~0020U~3~IM~LA~HEP A (VAQTA)~1|TYP~SANOFI PASTEUR~A0923~UNK~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0328427	10/14/2008	CA	29.0	29		F	10/14/2008	approx. 2 hours after receiving flu vaccine injection to left deltoid, arm very sore.Continued pain all evening, required vicodin. 18 hours after injection, entire arm sore. Fingers feel tingly and weak. Relates previous history of arm injury- unknown details.									U	10/13/2008	10/13/2008	0		PVT	UNK	unknown	none known	unknown			1						1	Muscular weakness; Pain in extremity; Paraesthesia	FLU3~SANOFI PASTEUR~2763AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328428	10/14/2008	OH	54.0	54		F	10/14/2008	Patient states got flu shot on 10-4-08. Stated shot hurt when recieved, but not issues immediately following shot. Patient said about 14 hours later pain woke her up with stiffness on her right side. Patient said went all the way down her right side, including hand, hip, and knee. Patient denied any tingling associated with stiffness. Patient denies any other problem with the shot. Patient stated last a couple of hours and has no residual pain and/or stiffness today.									Y	10/04/2008	10/05/2008	1	None	UNK	UNK	Unknown- none listed on form	None noted on form	Patient documented Degenerative Joint Disease,none other specified on form			1						1	Injection site pain; Musculoskeletal stiffness; Pain	FLU3~SANOFI PASTEUR~u2751aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328430	10/14/2008	TX	7.0	7		M	10/14/2008	Red, raised and swollen at injection site and the red raised area is 3-4 in diameter and growing.				Y					U	10/13/2008	10/14/2008	1		UNK	UNK	None	None	None			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2795AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328431	10/14/2008	OH	48.0	48		M	10/14/2008	10/14/08 8:00 AM  First noted hives on posterior aspect of both forearms and on anterior aspect of both thighs just above knees. At 3:00 PM hives are reduced to blotchy areas									Y	10/13/2008	10/14/2008	1	None	UNK	PVT	lisinopril with HCTZ   Trental	Stated none	Allergic reaction to PCN 30 years ago	None~ ()~NULL~~In Patient|None known~ ()~NULL~~In Sibling1		1						1	Rash macular; Urticaria	FLU3~SANOFI PASTEUR~U2747AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328432	10/14/2008	PA	20.0	20		M	10/14/2008	30 SEP 08 VACCINATED. 14 OCT 08 PAPULES FORM ON ARMS AND SPREAD TO ARMS, TRUNK-FRONT AND BACK, BOTH LEGS. SEEN AT MEDICAL CENTER BY DR. ZYRTEC, BENADRYL, MOTRIN.									Y	09/30/2008	10/14/2008	14		MIL	MIL		NONE	NONE			1						1	Rash papular; Biopsy skin; Dermatitis; Rash generalised; Rash papular; Rash pruritic; Vaccine positive rechallenge	ANTH~EMERGENT BIOSOLUTIONS~FAV149~1~SC~RA~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~5005522P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TYP~SANOFI PASTEUR~A09233~UNK~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|ANTH~UNKNOWN MANUFACTURER~~UNK~SC~UN~ANTHRAX (NO BRAND NAME)~2|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|SMALL~UNKNOWN MANUFACTURER~~UNK~~UN~SMALLPOX (NO BRAND NAME)~2|TYP~UNKNOWN MANUFACTURER~~UNK~UN~UN~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~2	USA		Influenza
0328434	10/14/2008	CO	53.0	53		F	10/14/2008	FLU LIKE SYNDROME, EXTREME PAIN AT INJECTION SITE, UNABLE TO MOVE ARM WITHOUT SEVERE PAIN.									Y	10/13/2008	10/13/2008	0		PVT	PVT	NONE	NONE	NONE			1						1	Influenza; Injected limb mobility decreased; Injection site pain; Pain in extremity	FLU3~SANOFI PASTEUR~UNK~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~UNK~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328435	10/14/2008	CO	43.0	43		M	10/14/2008	Following vaccine administration, 1 week of intermittant shakiness, can't get warm, dizziness and lightheadedness.				Y					U	10/07/2008	10/08/2008	1		UNK	PVT						1						1	Dizziness; Feeling cold; Tremor	FLU3~SANOFI PASTEUR~u2753aa~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328439	10/14/2008	IL	21.0	21		M	10/14/2008	rlq colicky abd pain and nausea 20 minutes after administration of flumist, no previous problems with flu vax or any vax									Y	10/07/2008	10/07/2008	0		MIL	MIL		none	nkda			1						1	Abdominal pain; Nausea; No reaction on previous exposure to drug	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0328440	10/14/2008	TN	81.0	81		M	10/14/2008	Patient developed a red, itchy rash on lower arms, upper leg and groin area and sides of abdomen.  He states his internist prescribed him a medrol dosepak and antibiotic and he he seems to be getting better.				Y					U	10/06/2008	10/08/2008	2		UNK	PUB						1						1	Rash erythematous; Rash pruritic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89985~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0554U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0328441	10/14/2008	IL	23.0	23		F	10/14/2008	Developed pruritis and wheals 10 minutes after flumist, mostly post neck and post ears, lungs clear, required IM benedryl, responded well, no sequelae. no previous hx of allergies or vax reactions									Y	10/06/2008	10/06/2008	0		MIL	MIL	ibuprofen prn, desogen daily	none				1						1	No reaction on previous exposure to drug; Pruritus; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0328442	10/14/2008	PA	73.0	73		F	10/14/2008	Lymphadenopathy									N	10/13/2008	10/13/2008	0	None	PVT	PVT	Novalog, Levoxyl, Altace, Lipitor, ASA, Fosamax, Os-cal, Multi Vitamin, Glucosamine, Chondroitin, Premarin	None	Diabetes, Hyperlipidemia, Hypothyroidism			1						1	Lymphadenopathy	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA358BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0328445	10/14/2008	KY	89.0	89		F	10/14/2008	This case was reported by a healthcare professional and described the occurrence of death-unknown cause in a 89-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included atrial fibrillation, cva and dementia. Concurrent medications included ATIVAN, PROZAC, LORTAB, PRILOSEC and CARAFATE. On 3 October 2008 at 17:15 the subject received a dose of FLULAVAL at 0.5 ml in the right arm. On 4 October 2008, approximately 21 hours after vaccination with FLULAVAL, the subject felt cool and clammy, had increased pulse and low blood pressure. Within 5 minutes, the subject experienced death-unknown cause. She was DNR (do not resuscitate). The healthcare professional considered the events were life threatening. The subject died on 4 October 2008, cause of death was not reported. It was unknown whether an autopsy was performed. 1/6/09-records received-Cause of Death-Sudden Cardiac Death. Cerebrovascular Disease. No autopsy performed.	Y	10/04/2008	Y						N	10/03/2008	10/04/2008	1	UNK	OTH	PVT	Lorazepam; Fluoxetine hydrochloride; Lortab; Omeprazole; Sucralfate	Atrial fibrillation, CVA, Dementia	The subject has no known drug or food allergies. She has previously received flu vaccines and has no history of reactions following previous flu or other vaccines.		A0751873A	1						1	Cold sweat; Heart rate increased; Hypotension	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Results in Death	Influenza
0328455	10/14/2008	TN	11.0	11		M	10/14/2008	Left arm with red, circular area approximately 15cm x 13.5cm, warm to touch and tender after receiving Varivax.				Y					Y	10/10/2008	10/11/2008	1	Benadryl; Ibuprofen	PVT	PVT	Focalin; Vitamin; Fiber tablet	None	None			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLUN3~MEDIMMUNE VACCINES, INC.~500541P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52802403~1~UN~RA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1140X~2~UN~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0328456	10/14/2008	MA	45.0	45		F	10/14/2008	Sweating, Fever, and Headache left to go home.									Y	10/13/2008	10/13/2008	0	None	PUB	PVT						1						1	Headache; Hyperhidrosis; Pyrexia	FLU3~SANOFI PASTEUR~V2784AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328457	10/14/2008	MA	60.0	60		F	10/14/2008	violently ill temp 103  shaking chills now-malaise									Y	10/13/2008	10/13/2008	0		PUB	UNK		No	No			1						1	Body temperature increased; Chills; Malaise; Tremor	FLU3~SANOFI PASTEUR~V276YAA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328458	10/14/2008	MA	50.0	50		F	10/14/2008	Throat closing, eyes itchy, temp 102, headache.									Y	10/07/2008	10/07/2008	0		PUB	UNK						1						1	Body temperature increased; Eye pruritus; Headache; Throat tightness	FLU3~SANOFI PASTEUR~V2764AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328459	10/14/2008	NJ	38.0	38		M	10/06/2008	10cm area of redness around area of the head/arms/back/chest/legs with eruption of acneoform pustules.									N	09/25/2008	10/04/2008	9		MIL	MIL		None				1						1	Dermatitis acneiform; Erythema	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~EMERGENT BIOSOLUTIONS~VV04003~UNK~~~SMALLPOX (ACAM2000)~1	USA		Influenza
0328461	10/14/2008	NM	83.0	83		M	10/10/2008	Patient reported extensive soreness and swelling throughout his upper right arm.  Above his right elbow he had a large bump.  His entire upper arm was warm to the touch.  He was advised to see a doctor ASAP.  Doctor at urgent care advised that it was an adverse reaction to the PNEUMOVAX.  He was advised to ice the area and keep it wrapped.  After follow-up with patient, he was reported full recovery.				Y					Y	10/09/2008	10/10/2008	1		OTH	PVT		None	None			1						1	Injection site mass; Injection site pain; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89988~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1381U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0328463	10/14/2008	PA	60.0	60		F	10/14/2008	Patient received both PNEUMOVAX-23 and Influenza vaccine in her left arm, upper and lower deltoid (pt requested same arm). Pt reported redness and pain in upper arm in 24hrs. In 48hrs exam showed 20cm circular warm erythematous area in the (L) deltoid with minimal pain.									Y	10/08/2008	10/08/2008	0		PVT	PVT		None	HTN, NIDDM, Hyperlipidemia			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U2758AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0551X~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328464	10/14/2008	MO	46.0	46		F	10/14/2008	4 hr after IM injection intense pruritus redness and edema developed 12x11cm (R) deltoid Tx with oral antihistamines and topical cortisone cream									Y	10/05/2008	10/06/2008	1		PVT	PVT		None	None			1						1	Injection site erythema; Injection site oedema; Injection site pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA367EA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0328465	10/14/2008	IL	70.0	70		F	10/13/2008	Subject said she didn't fell well and was very tired after her vaccinations on 10/06/2008.  In the morning on 10/07/2008 she woke  us and her arm was painful, swollen, re and warm from her shoulder about 3 inches above her elbow of her right arm (the arm of the PNEUMOVAX vaccine).  She said she had temperature of about 101 degrees.  She saw a Dr  who put her on CEPHALEXIN 500mg, 1 cap tid for 1 week for cellulitis.  She had a follow up with her regular MD, on 10/10/08.  She stated that she had her first PNEUMOVAX in 2003 and Dr. wanted her to repeat it this year. RPh called her on 10/08/08 to discuss reaction and on 10/13/08 to follow up.  The patient stated that her condition had resolved.									Y	10/06/2008	10/07/2008	1		OTH	PUB	METAREX, TRICOR	None	None			1						1	Body temperature increased; Cellulitis; Erythema; Fatigue; Malaise; Oedema peripheral; Pain in extremity; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882V~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0551X~2~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328467	10/14/2008	KY	69.0	69		M	10/14/2008	1 day past, Arm swelling and not felling well. 2nd day passed, arm swelling more and lymph nodes in neck swelling. Feeling sick, told to take benedryl.									Y	10/04/2008	10/05/2008	1		OTH	PVT						1						1	Lymphadenopathy; Malaise; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~0142X~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~89972~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328468	10/14/2008	TX	1.9	1	.9	F	10/14/2008	Some swelling and tenderness on left thigh										10/14/2008	10/14/2008	0		PVT	UNK						1						1	Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~UT286FA~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328469	10/14/2008	TX	32.0	32		F	10/08/2008	pt returned to imz. table reporting trouble swallowing felt something in throat. Pt had personal Epi Pen, this was administered at 350. BP were taken and documented, 911 was called and transported her				Y					Y	10/08/2008	10/08/2008	0		OTH	UNK			Sulfa, PCN, dairy, corn			1						1	Dysphagia; Sensation of foreign body	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89884~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0328470	10/14/2008	MN	17.0	17		F	10/14/2008	Pt. received two 0.5cc FLUZONE lot#U2811AA										10/14/2008				PVT	PVT		None	Asthma			1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U2811AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB294BA~1~IM~LA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~0548X~1~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0328473	10/14/2008	OH	50.0	50		F	10/14/2008	Patient c/o shaking/chills, with associated neck pain x15min after receiving the flu vaccine. Occurred ~ 5 mins. after receiving vaccine. Uneasy feeling continued for several hrs. Symptoms resolved by next day.									Y	10/13/2008	10/13/2008	0	None	PVT	PVT	CRESTOR, VICODIN	none knowwn	Back surgery x2, NKDA, Hyperlipidemia			1						1	Chills; Feeling abnormal; Neck pain; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA375AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0328474	10/14/2008	VA	16.0	16		F	10/13/2008	Rash on abdomen right side, appears on (day4) after infection.				Y					Y	09/30/2008				PVT	PVT	BCP'S , Lexa pro		Allergic to morphine			1						1	Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~0548X~6~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|HPV4~MERCK & CO. INC.~AFLUA155AA~6~IM~RA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0328475	10/14/2008	SC	15.0	15		F	10/14/2008	10CM X 5cm Red area, burning, itching, warm and painful to touch for eight to ten hours. Benadryl given by mother for relief.				Y					Y	10/10/2008	10/11/2008	1		PVT	PUB	None	None	None			1						1	Burning sensation; Erythema; Pain; Pruritus; Skin warm	FLU3~SANOFI PASTEUR~U2828AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0387U~1~IM~RA~HPV (GARDASIL)~1|VARCEL~MERCK & CO. INC.~0101X~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0328476	10/14/2008	FL	62.0	62		M	10/15/2008	Bedtime Friday 10PM 10/10 with sore arm. Woke up at midnight-1AM with swollen lips, whelps around groin area/armpits. Both upper arms, waist. 10/11 took BENADRYL 2 tabs (25 mg) and went back to bed. Up at 6:30AM , went for a walk stop to rest, hives had decreased with med q 4-6 hours. 10/13/08- body aches fever-none.				Y					Y	10/09/2008	10/11/2008	2		OTH	PUB	None	None	None			1						1	Lip swelling; Pain in extremity; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA388BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0328478	10/14/2008	PA	48.0	48		F	10/14/2008	10-10-08 patient called- reported  numb/tingle left thumb. Left arm throbbing. 10-13-08 office visit - pain left arm decreased range of motion in left shoulder				Y					N	10/13/2008			CBC - WNL	PVT	PVT						1						1	Full blood count normal; Hypoaesthesia; Joint range of motion decreased; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0328479	10/14/2008	MI	3.0	3		M	10/13/2008	Patient received (age 3) Flu vaccine, watched his sister get several vaccines and subsequently became diaphoretic, pastly, glassy eyed with episode of vomiting, No loss of consciousness. O2 by mask give, juice given. Color came back and after observation for about  30 - 4d days back to normal.									Y	10/13/2008	10/13/2008	0	None	PVT	PVT		No	No			1						1	Hyperhidrosis; Oxygen supplementation; Pallor; Staring; Vomiting	FLU3~SANOFI PASTEUR~U2832AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328480	10/14/2008	NC	30.0	30		F	10/14/2008	Patient is pregnant (14 weeks), Nausea, Fatigue and achiness. Began 3am 10/13/2008 and is ongoing . Patient also experiencing headaches. (Onset prior to vaccine)									N	10/07/2008	10/13/2008	6		OTH	PVT	Prenatal vitamin; Zofran	None	Pregnancy	~Influenza (Seasonal) (no brand name)~1~17.00~In Patient		1						1	Drug exposure during pregnancy; Fatigue; Headache; Nausea; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89884~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0328481	10/14/2008	MD	59.0	59		F	10/12/2008	Stiffing Pain with numbness and throbbing when lifting arm.									U	10/01/2008	10/03/2008	2		PVT	PVT			Aspirin			1						1	Hypoaesthesia; Musculoskeletal stiffness; Pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA151AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0328482	10/14/2008	CA	2.0	2	.5	M	10/14/2008	0.5 cc given to patient instead of 0.25 cc.									U	10/13/2008			note-received Flu vaccine also in 2007	PVT	UNK		None	None			1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~UT2785AA~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328483	10/14/2008	OH	58.0	58		F	10/11/2008	Local reaction at site of injection - full body itchy Rash.										10/07/2008	10/07/2008	0	ASO,CBC	PVT	PVT	Albutersol Sulfate, Centrum Silver, Clonidine HCL, Lotrel, Vitamins, Glucosamine Chondroit- Collagen, One Touch Ultra Device, test BID alternating before meals and before bed Albutersol Sulfate Inhalation Aerosol Solution, Spiriva Handihale		Unspecified Hypothyroidism, DB W/O Comp typeII / UNS not Uncntrl, Mixed Hyperlipidemia, Obesity, Depression, Essential Hypertension, Benign, COPD with Asthma Nos, Renal Failure Chronic, Arthritis site nos, Other Malaise and Fatigue, Abnormal Kidney Function Studies.			1						1	Full blood count; Injection site reaction; Local reaction; Rash generalised; Rash pruritic; Streptococcal identification test	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89975~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0233X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328484	10/14/2008	IL	3.0	3		M	10/14/2008	Diffuse urticaria joint pain requiring treatment with oral steroids and antihistamines. Symptoms persisted x 4 days. Child seen in office twice and E.D. twice for worsening symptoms. Resolution of symptoms reported 10/12/08				Y					Y	10/06/2008	10/06/2008	0		PVT	PVT	None	Upper Respiratory Infection				1						1	Arthralgia; Urticaria	FLU3~SANOFI PASTEUR~U2788DA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328485	10/14/2008	NY	81.0	81		F	10/14/2008	severe malaise, fatigue, muscle tenderness (generalised) difficulty with standing and walking without assistance.				Y						10/08/2008	10/09/2008	1	cx, BMP	PVT	PVT	HCTZ, Kayekalae, Calcium, ASA, FOSAMAX, Micardis, Synth	None	Renal insufficiency, Hyperkalemia			1						1	Culture; Dysstasia; Fatigue; Gait disturbance; Malaise; Metabolic function test; Myalgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA151AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0328444	10/15/2008	CA	56.0	56		F	10/15/2008	Severe headache, undoubtably a migrane. Began approx 4 hours after vacinnation and ended approx 3 hours later.  I very rarely get migrane headaches - approx one evry 2 years so this seemd like too much of a coincidence									Y	10/13/2008	10/13/2008	0	No medical treatment other than by patient (me)NOTE: I do not know the manufacter - I put down the first one just so that I could complete the form - contact the hospital if you really want to know this applies to 13 and 14	PUB	UNK	none	none	none			1						1	Condition aggravated; Migraine	FLU3~CSL LIMITED~~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0328515	10/15/2008	MO	1.5	1	.5	M	10/10/2008	Slow regression into autism. Acting deaf, not social, spinning, Coxsackie virus, lost words, pectus excavatum, bowel problems, loss of eye contact, temper tantrums, hearing became very sensitive. 12/2/08 Reviewed PCP medical records of 3/15/04-5/17/2005. FINAL DX: autism Records include developmental peds eval of 4/27/2005 which revealed speech loss & regression of skills since 2.5 yo.  Sterotyped repetetive play behaviors, reduced eye contact, picky eater, hyperactive, tantrums, underweight,   Had been in early intervention program & receiving PT/OT/ST since 1/2005.								Y	N	12/02/2003	12/20/2003	18	high (toxic) heavy metal counts.	PUB	PUB			none, very healthy and normal.  PMH: Pectus excavatum.  Viral illness w/fever, cough, runny nose, vomiting, diarrhea.  Strep pharyngitis.  Drug rash from amoxicillin.  Coxsackie virus.  sibling w/cardiac arrhythmia.  Family hx: cardiac arrhythmia, speech & learning disabilities, dyslexia, migraines, thyroid disease.			1						1	Abnormal behaviour; Aggression; Antisocial behaviour; Aphasia; Autism; Blood heavy metal increased; Coxsackie viral infection; Disturbance in attention; Hyperacusis; Intestinal functional disorder; Pectus excavatum; Social avoidant behaviour; Stereotypy; Unresponsive to stimuli	FLU3~SANOFI PASTEUR~U1260AA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0328517	10/15/2008	CA	65.0	65		F	10/06/2008	High fever x for several days (chills shakes) Arm hot- Hard- red- large area swollen nausea; headache brown urine, weak, felt miserable! (102 degrees)									Y	09/30/2008	10/01/2008	1		PVT	PVT		None				1						1	Asthenia; Chills; Chromaturia; Erythema; Feeling abnormal; Headache; Induration; Nausea; Oedema peripheral; Pyrexia; Skin warm; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0328518	10/15/2008	MA	20.0	20		F	10/09/2008	2-3 hours after receiving vaccine developed tightness in chest, coughing, zero wheezing or edema in face, throat.  Seen in ED, no treatment. Fine 24 hrs later.				Y					Y	10/08/2008	10/08/2008	0	chest x-ray;   EKG negative	MIL	UNK	None	None	None			1						1	Chest X-ray; Chest discomfort; Cough; Electrocardiogram normal	FLU3~SANOFI PASTEUR~U2784EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328519	10/15/2008	MI	80.0	80		M	10/07/2008	Swelling, redness in right arm at injection site at 2:00am Friday 10/03/08.  Patient iced site and swelling resolved.  Later in evening 10/03/08 swelled again and took BENADRYL and condition resolved.									Y	10/02/2008	10/03/2008	1	None	OTH	PUB	LOVASTATIN;  LISINODRIL;  HYDROCHLOROTHIAZIDE					1						1	Injection site erythema; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0224X~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328522	10/15/2008	TX	25.0	25		F	09/29/2008	pt received 4 vaccines on 9/25/08.  PNEUM0VAX + FLUZONE on (L) arm, HAVRIX + BOOSTRIX on R arm.  On 9/26/08 pt developed fever of 102 degrees - 9/27/08.  On 9/28 swelling started on (R) arm.  Today at 11:50 am area of erythema + induration on deltoid 100mm + 2 inches below are of erythema + induration 64mm.									Y	09/25/2008	09/26/2008	1	No	PUB	PUB		None	allergy to ant bites			1						1	Erythema; Induration; Oedema peripheral; Pyrexia	FLU3~SANOFI PASTEUR~U2740AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB2S2AA~1~IM~RA~HEP A (HAVRIX)~1|PPV~MERCK & CO. INC.~03809~1~SC~LA~PNEUMO (PNEUMOVAX)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~C29668AA~1~IM~RA~TDAP (BOOSTRIX)~1	USA		Influenza
0328527	10/15/2008	MS	75.0	75		M	10/07/2008	Fever- 1 day, Sharp pain in muscle and shot site, Red Skin rash on front upper arm from shoulder to elbow - 3 Days. Took Benedryl, 7 nites , events seemed to go away on their own.									Y	10/02/2008	10/02/2008	0		OTH	OTH	Vitamins, Aspirin, peiva - Statin Nabumetone					1						1	Injection site pain; Myalgia; Pyrexia; Rash erythematous	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA380AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0988F~2~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328528	10/15/2008	NE	5.0	5		M	10/07/2008	About 36 hours after vaccine was administered pt had a suspected seizure which included shaking of arms and legs and eyes rolled back.  Lasted about 1 minute.  Pt had complained of leg muscle pain before symptoms started.  Taken to ER right after.  No previous history of seizure.				Y					Y	09/29/2008	09/30/2008	1	Head CT scan, normal;  Electrolytes & glucose, normal;  EEG, to be performed.	PVT	PUB	None	None	Headaches, resolved;  Chiarimal formation			1						1	Blood electrolytes normal; Blood glucose normal; Computerised tomogram normal; Gaze palsy; Myalgia; Tremor	FLUN3~MEDIMMUNE VACCINES, INC.~500560P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0328530	10/15/2008	IL	53.0			F	10/08/2008	received vaccine at 7am on 10/3/08-  45 minutes later itching of lips- swelling.  given 50mg oral BENADRYL- did fine full recovery				Y					Y	10/03/2008	10/03/2008	0	None	PVT	PVT		None	sinusitis in past			1						1	Lip swelling; Pruritus	FLU3~SANOFI PASTEUR~U2771AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328531	10/15/2008	NJ	41.0	41		F		Higher fever chills, Muscles aches headache. Received shot at 10:30 Friday 10/3/2008 headache starts shortly after that. Relief at 4:30 am Saturday 10/4/2008 No treatment									Y	10/03/2008	10/03/2008	0		OTH	PVT		NO	No			1						1	Chills; Headache; Myalgia; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLL191AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0328532	10/15/2008	CA	2.0	2	.0	M	10/04/2008	Patient developed large, red, tender, swelling over left lateral thigh injection site.  Fever to 102.5 F x 30 hours and pink papules over thigh, trunk and back with mild pruritus.				Y					Y	10/01/2008	10/02/2008	1	None	PVT	PVT	Montelukost	None	Reactive airways disease; MRSA abscess			1						1	Injection site erythema; Injection site pain; Injection site swelling; Pruritus; Pyrexia; Rash erythematous; Rash papular	FLU3~SANOFI PASTEUR~UT2782CA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328533	10/15/2008	NY	48.0	48		M	10/08/2008	Getting ready for bed 10 to 10pm chills,unable to get warm - woke middle of the night - everything ached.  1230 pm 10/8/08 less achy with 3 Ibuprofen, no chills.  Feeling better today, slowly improving.				Y						10/07/2008	10/07/2008	0	None	PVT	PVT	None	None	NKDA - hyperglycermia dyslipidemia			1						1	Chills; Feeling cold; Pain	FLU3~SANOFI PASTEUR~U2762AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328535	10/15/2008	SC	73.0	73		F	10/10/2008	Right arm extremely sore and difficult for patient to move still (6 days after injection).									Y	10/02/2008	10/02/2008	0		OTH	OTH	Ativan 1mg					1						1	Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2764AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328538	10/15/2008	AZ	30.0	30		M	10/08/2008	Tender Erythematous  Left arm at site of vaccination injection										10/06/2008	10/07/2008	1	None	UNK	UNK		None	DM2, Hepatitis A			1						1	Injection site erythema; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89619~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~9722106~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328539	10/15/2008	CO	55.0	55		F	10/10/2008	10/01/08 given Pneumococcal in right arm 2 pm.  3:30 pm - red area at injection site.  10/02/08 extreme fatigue, fever of 99.2 - felt disoriented - unable to raise right arm.  10/03/08 arm not swollen - fatigue, T 99.  Symptoms lessened over next few days.  Felt 100% better on 10/07/08.									Y	10/01/2008	10/01/2008	0	None	PVT	PVT	Motrin: Combipatch/Vivelie	None	Exercise induced asthma; Malignant melanoma			1						1	Disorientation; Fatigue; Injected limb mobility decreased; Injection site erythema; Pyrexia	FLU3~SANOFI PASTEUR~AFLUA350AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB569AA~3~IM~LA~HEP B (ENGERIX-B)~1|PPV~MERCK & CO. INC.~1382U~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328540	10/15/2008	WA	61.0	61		F	10/09/2008	Offered flu shots 10/8/08.  11 am shot was administered.  1 pm my upper arm started hurting.  (At no time did I have problems breathing).  3 pm it hurt to swallow and I felt a lump in my throat.  4 pm - lump felt bigger so I took cold medication (for antihistamine).  5:30 pm - at home I took 2 Benadryl and over the evening the lump decreased.  10/9/08 - Lump in throat gone but upper arm sore and I have no energy.									Y	10/08/2008	10/08/2008	0	None	OTH	OTH	None	None	Metronizodol			1						1	Asthenia; Odynophagia; Pain in extremity; Sensation of foreign body	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328541	10/15/2008	FL	5.0	5		F	10/06/2008	At home acute onset swelling eyes lids - raised red rash- itchy all over - seen at office 09/25 with eyelid edema, macular rash on neck with 2 hives - got BENADRYL and PRELONE- seen again at urgent center 09/25 with increased itchy -? SOB - both times lungs clear no wheeze				Y					Y	09/24/2008	09/24/2008	0	NO allergies	PVT	PUB		Allergic rhinitis				1						1	Dyspnoea; Eyelid oedema; Pruritus; Rash erythematous; Rash macular; Urticaria	FLU3~SANOFI PASTEUR~U2811AA~4~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB29ACA~1~IM~~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0328542	10/15/2008	AZ	43.0	43		F		About 3 min after injection I felt numbness in left arm, fingers swollen, about tenminutes later, lips started to tingle									Y	10/06/2008	10/06/2008	0		MIL	UNK			Epilepsy			1						1	Hypoaesthesia; Immediate post-injection reaction; Oedema peripheral; Paraesthesia oral	FLU3~CSL LIMITED~01449111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0328543	10/15/2008	AZ	25.0			F	10/06/2008	Blackout with dizziness, nausea, headache, weakness									Y	10/06/2008	10/06/2008	0		UNK	UNK						1						1	Asthenia; Dizziness; Headache; Loss of consciousness; Nausea	ANTH~EMERGENT BIOSOLUTIONS~FAU148~5~SC~LA~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~50053P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TYP~SANOFI PASTEUR~B0347~2~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0328544	10/15/2008	KY	12.0	12		M	10/09/2008	10/6/08 VARIVAX *2 given in (R) arm + FLUMIST given intranasally.  10/7/08 (R) arm swollen + red & zero side of face/eyelid swollen + eye droopy.  Ice and Heat applied.  ADVIL given. zero fever.  10/8/08 arm still swollen, both sides of face swollen.  seen in office swelling/redness decreased o/c heat.  Applied  ice, BENADRYL.									Y	10/06/2008	10/07/2008	1		PVT	PVT						1						1	Erythema; Eyelid oedema; Eyelid ptosis; Oedema peripheral; Swelling face	FLUN3~MEDIMMUNE VACCINES, INC.~500544p~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~1134x~2~UN~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0328549	10/15/2008	OH	13.0	13		F	10/14/2008	Became pale , lost consciousness for 30sec, became tingly in legs. Blood pressure 82/60, 10 mins later Blood pressure 100/68 went to ER via parents, patient being checked by Emt's, Called mother 2pm,daughters is fine no adverse results, no need for ep.				Y					Y	10/04/2008	10/04/2008	0		OTH	UNK		None	None			1						1	Blood pressure decreased; Loss of consciousness; Pallor; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA207AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0328550	10/15/2008	OH	15.0	15		F	10/04/2008	Became pale c/o hearing and vision impairment, upset stomach. Blood pressure 80/66, ten minutes later Blood pressure 100/66, went to ER via parents. Patient  being checked by EMT's, called mother 2 pm daughter is fine no adverse results. No need for epi.				Y					Y	10/04/2008	10/04/2008	0		OTH	PVT		None	None			1						1	Blood pressure decreased; Hearing impaired; Pallor; Stomach discomfort; Visual disturbance	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA207AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0328553	10/15/2008	FL	12.0	12		F	10/09/2008	Seizure-like movement and syncope with 1 minute of injection. Disorientation x 5 minutes.									Y	10/09/2008	10/09/2008	0	Healthy - here for well-child exam	PVT	OTH		None	None			1						1	Convulsion; Disorientation; Syncope	FLU3~SANOFI PASTEUR~U2798EA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B024DB~6~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0328554	10/15/2008	GA	61.0	61		F	10/09/2008	Hoarseness, fast/ erratic heartbeat, dizziness Blood pressure shot up. Did not go to Dr. Ill for several days									Y	10/02/2008	10/03/2008	1		UNK	UNK						1						1	Blood pressure increased; Dizziness; Dysphonia; Heart rate increased; Heart rate irregular; Malaise	FLUX~UNKNOWN MANUFACTURER~~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328555	10/15/2008	OH	33.0	33		F	10/08/2008	complaints of heart palpitations, hot flashes, feeling fuzzy in her head - 1 1/2 hr after FLUARIX injection. BP 152/96, P-102 - 10:20 AM. 10:37 AM BP 132/80, P-82. Foggy feeling still present other symptoms gone. 11 AM BP 132/80, P-80, 11:15 AM BP 110/80, P-76									Y	10/08/2008	10/08/2008	0		PUB	UNK	None	None	None			1						1	Feeling abnormal; Hot flush; Palpitations	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA207AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0328556	10/15/2008	OR	33.0	33		F	10/09/2008	33 year old here this morning for WWE got DTAP & Flu shot approx 5 hrs ago/ Feels muddled like it's hard to think, feel like it may be harder to breathe than normal. Pain in back & kind of weak & shaky all over.									U	10/09/2008	10/09/2008	0	Clinical exam completely normal	PVT	PVT		No	Allergic to Penicillin			1						1	Asthenia; Back pain; Bradyphrenia; Dyspnoea; Tremor	FLU3~SANOFI PASTEUR~U2785GA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2994BA~UNK~UN~LA~TDAP (ADACEL)~1	USA		Influenza
0328558	10/15/2008	KY	74.0	74		F	10/10/2008	3 days after receiving PNEUMOVAX - developed erythema & edema at injection site and distal to injection site				Y						10/08/2008	10/08/2008	0	CBC; WBC 10.3	UNK	UNK		No	NKMA - COPD, anxiety/depression, Osteoporosis			1						1	Injection site erythema; Injection site oedema; White blood cell count increased	FLU3~CSL LIMITED~02349111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~0554U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0328563	10/15/2008	TX	67.0	67		F	10/08/2008	(R) deltoid warm to touch, red began 10/7/08, 5 cm. Family reports area smaller today (note, found out client had pneumococcal vaccine in 12/16/04).									Y	10/06/2008	10/07/2008	1		PUB	PUB	Cholesterol; ASA; Vitamins medication	None	Cholesterol			1						1	Erythema; Skin warm	FLU3~SANOFI PASTEUR~U2768AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328575	10/15/2008	NY				M	10/15/2008	Very high fever throughout the night. Very high. Delirium.									Y					UNK	UNK		no	no			1						1	Delirium; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328576	10/15/2008	MO	68.0	68		F	10/15/2008	10/14/2008 11:10am shot in left arm. 11:50am discomfort in left arm. 1:00pm pain in lower back, tingling in hands and feet. 2:30pm symptoms increased intensity. 3:00pm went to doctor's office.  Vitals normal except for bp 170/67(?)  Doctor's diagnosis panic attack. Note:  I am husband and I received shot same time.  No problem.  My layman opinion is the panic attack was due to reaction to shot.  Her breathing was normal until we entered doctor's office.  6:00pm red rash appeared on upper left arm. The system would NOT let me submit without mfg info.  Help line told me to just pick one at random.				Y					Y	10/14/2008	10/14/2008	0		PVT	UNK		none	none			1						1	Back pain; Limb discomfort; Panic attack; Paraesthesia; Rash erythematous	FLU3~CSL LIMITED~~UNK~~~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0328577	10/15/2008	TX	68.0	68		M	10/15/2008	Patient was vaccinated on 10/13/2008 in the AM.  He ate lunch then went to Physical Therapy for rehabilitation following knee replacement surgery. He died during his PT appointment. 5/5/09-death certificate received-Final COD cardio pulmonary arrest.	Y	10/13/2008							N	10/13/2008	10/13/2008	0		UNK	UNK		Post Knee replacement	Unknown			1						1	Death	FLU3~SANOFI PASTEUR~U2802AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0328580	10/15/2008	MN	69.0	69		M	10/15/2008	patient given the flumist.  No symptoms.  Patient called to return to clinic to receive the flu injection.									U	10/13/2008				PVT	UNK						1						1	Wrong drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500543P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0328581	10/15/2008	MN	65.0	65		F	10/15/2008	Patient given the flumist and is over the age of 49.  No symptoms.  Patient notified, and will return to clinic to receive the flu injection.									U	10/13/2008				PVT	UNK						1						1	Inappropriate schedule of drug administration; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500543P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0328582	10/15/2008	MN	46.0	46		F	10/15/2008	in 24 hours fever weakness fatigue nnasea vomiting headache now thing encephalitis. In hospital 2 days dehydrated IV fluids, pain med anti nausea and now 9 day course of predisone.				Y	Y	2			N	10/03/2008	10/04/2008	1		UNK	UNK		none	rheumatoid arthritis ashtma			1						1	Asthenia; Dehydration; Encephalitis; Fatigue; Headache; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2798CA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0235X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0328583	10/15/2008	AL	2.0	2	.6	F	10/15/2008	Pt. had seigure like activity and was sent to women and children's ER. 10/23/08-records received for DOS 10/8-10/9/08-DC DX: Seizures. Presented with seizures in ER. No fever. Loss of consciousness.				Y	Y	1			Y	10/07/2008	10/07/2008	0	Spinal Tap, head Ct cbc, cmp, crp toxic screen ua 10/23/08-records received- CT normal. LP normal. EEG normal.	UNK	UNK	singular	otitus medica		none~ ()~~0.00~In Patient|none~ ()~~0.00~In Sibling		1						1	C-reactive protein; Convulsion; Full blood count; Metabolic function test; Toxicologic test; Urine analysis	FLUN3~MEDIMMUNE VACCINES, INC.~500547p~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0328585	10/15/2008	WA	52.0	52		F	10/15/2008	Vaccinated with inactivated influenza vaccine on 10/13/08.  On 10/14/08 noted pain and rash in axilla of vaccinated arm as well as erythema and induration at vaccine site.  Vaccine site is warm to touch. Erythema measures 30mm by 50mm.									Y	10/13/2008	10/14/2008	1		PVT	PVT	Vicadin and multivitamin	None	Allergy to PCN, Fiorinal.			1						1	Axillary pain; Injection site erythema; Injection site induration; Injection site warmth; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFUA357BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0328587	10/15/2008	OK	70.0	70		M	10/15/2008	70 year old patient c/o high fever with shakes, wheezing, weakness, dizziness and urinary incontinence.									Y	10/14/2008	10/14/2008	0	none	PUB	UNK	NONE	NONE	KEFLEX	NONE~ ()~NULL~~In Patient		1						1	Asthenia; Dizziness; Pyrexia; Tremor; Urinary incontinence; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA181AA~4~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0742X~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328588	10/15/2008	NC	60.0	60		F	10/15/2008	Back ache, eyes burning and bloodshot, tongue swollen, blisters in mouth,chills.									Y	10/13/2008	10/13/2008	0	NONE	UNK	PVT			CONGENITAL HEART MURMURS, S/P CA BREAST (3 YRS)	EYE REDNESS~Influenza (Seasonal) (no brand name)~1~52.80~In Patient		1						1	Back pain; Chills; Eye irritation; Ocular hyperaemia; Oropharyngeal blistering; Swollen tongue	FLU3~SANOFI PASTEUR~U2740AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328589	10/15/2008	MN	37.0	37		F	10/15/2008	60mm circle around the injection site. Hard warm/hot bump. Stiff and very tender, itchy, very uncomfortable. Took Tylenol and Benedryl and my Alegra for the itching. Went back to the cllinic to see what was going on and was told I was having a reaction to the injection. Today is the 15th and I still have the itching and tenderness, but the redness seems to be going away.									Y	10/10/2008	10/11/2008	1	Followed up the the clinic listed about for the diagnosis	PUB	PVT		none	seasonal allergies			1						1	Injection site discomfort; Injection site induration; Injection site mass; Injection site pain; Injection site pruritus; Injection site reaction; Injection site warmth; Musculoskeletal stiffness	FLUX~UNKNOWN MANUFACTURER~~5~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328590	10/15/2008	NM	88.0	88		F	10/15/2008	Entire lateral upper arm is bruised from the injection point on the left deltoid down to approximately 1 inch above elbow.				Y					U	10/10/2008	10/10/2008	0		UNK	PVT	Hyzaar, nitroglycerin, xoponex, spiriva, amlodipine	none	sulfa allergy, hypertension, COPD, angina			1						1	Injection site bruising	FLU3~SANOFI PASTEUR~U2759AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328592	10/15/2008	OH	39.0	39		F	10/15/2008	Recieved Flu Vaccine at around 2:00 pm, by 5:00 pm of the same day I had a high fever 101.6, muscle aches, cough, stuffed up nose (so severe everytime I swalled my tongue was sucked up to the back of my throat), red blood shot eyes with yellowish discharge, sore/scrathcy throat, chills/ cold sweat.  When I got up the next morning both eyes were matted shut with a yellowish discharge.  By 12:30 pm the next day I still have a fever, aches, red blood shot eyes, with a yellow discharge and cold chills.									U	10/14/2008	10/14/2008	0	None	PUB	UNK	Glucotrol, magnesium, synthroid, premarin,januvia, amiloride, b12 injections.	None	Diabetic, hypothroidism, hypomagnesium, b12 anemia			1						1	Chills; Cold sweat; Cough; Eye discharge; Myalgia; Nasal congestion; Ocular hyperaemia; Oropharyngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328593	10/15/2008	PA	15.0	15		F	10/15/2008	ARM RED AND SORE DUE TO VARICELLA SHOT									Y	10/07/2008	10/10/2008	3	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Erythema; Pain in extremity	FLU3~SANOFI PASTEUR~U2177AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1002X~UNK~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0328595	10/15/2008	MD	14.0	14		F	10/15/2008	On the way home from the doctors office she complained of feeling nausea. We thought it was the heat along with being in the car as she is suceptiable to migraine headaches, or that she may have been hungry, because she hadn't eaten much in the morning. She had a little something to eat, came home and went to sleep. Woke up in the evening had a little dinner did some homework and went back to bed. All this time complaining of not feeling well. When she woke the next day and tried to get ready for school she felt dizzy, and right before we were to leave to take her to school, she vommited. She stayed home from school not feeling well throught the day. Having dry heaves, afraid to eat or drink much. Also complaining of body aches, continued dizziness. We are now into the next day and she is still not feeling well. Sleeping alot, body aches, dizzy, a bit of a dry/sore throat, and having a slight fever.									U	10/13/2008	10/14/2008	1	Note about Tdap has had 5 previous doses of some kind of Polio vaccine. DTP-DtaP, 5/19/94, 7/26/94,9/1/94,11/2/95,4/30/99.	PVT	PUB		No real physical illness, however patient was recently diagnosed with conversion reaction disorder. Had been taken to the ER twice. First time was September 1, 2008.	Recently diagnosed with conversion reaction disorder, (9/1/08). She was also diagnosed with precocious puberty. Symptoms originally started when patient was two years old. Then stopped only to begin again at 6 1/2. She was treated with injections to slow physical development.			1						1	Activities of daily living impaired; Dizziness; Dry throat; Hypersomnia; Malaise; Nausea; Oropharyngeal pain; Pain; Pyrexia; Retching; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500558P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MEN~SANOFI PASTEUR~42734AA~1~IM~LA~MENINGOCOCCAL (MENOMUNE)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B024E~6~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0328596	10/15/2008	OH	33.0	33		F	10/15/2008	redness, fever, aches 10/16/08-records received for DOS 9/28-10/2/08-DC DX: Cellulitis to right arm. Presented to ED with C/O right arm pain, redness at injection site that began 3-4 days ago. C/O chills, sweats and increased redness. Day of vaccines C/O sinus infection, diagnosed with sinusitis.					Y	4			Y	09/24/2008	09/24/2008	0	WBC, blood cultures, MRI and bone scan Arm 10/16/08-records received-WBC 17.8, MRI of arm revealed peripheral cellulitis and abscess like lesion. Ultrasound showed inflammation.	UNK	UNK		congestion, slight cough	asplenia, spherocyosis, allergic rhinitis 10/16/08-records received-PMH: hereditary spherocytosis. Pseudocholinesterase deficiency. Splenectomy. Smoker. Alcohol use.			1						1	Blood culture; Bone scan; Erythema; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflla158aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1679U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~uf452ca~UNK~IM~LA~TDAP (ADACEL)~1	USA	Hospitalisation	Influenza
0328597	10/15/2008	NY	29.0	29		M	10/15/2008	SM. RECEIVED SMALLPOX ON 2OCT2008. SM. DID NOT KNOW AT THIS TIME HE WAS ALLERGIC TO LATEX. WAS ASKED PRIOR TO VACCINATION. SM. DEVELOPED HIVES ON ARMS, CHEST, STOMACH, AND ARMPITS.ALSO SWELLING OF THE THROAT 1 TO 2 DAYS AFTER VACCINATION.  SM. FOUND OUT ABOUT ALLERGY TO LATEX IN ANOTHER PROCEDURE BY A DIFFERENT CLINIC. WAS GIVEN ANTIBIOTICS, BENADRYL, AND NEW ALLERGY TAGS WITH LATEX ADDED TO THEM.									Y	10/02/2008	10/03/2008	1		MIL	MIL	NONE LISTED	NONE NOTED	PRIOR ALLERGY TO SULFA DRUGS			1						1	Latex allergy; Pharyngeal oedema; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~EMERGENT BIOSOLUTIONS~W04003A~1~ID~LA~SMALLPOX (ACAM2000)~1	USA		Influenza
0328598	10/15/2008	VA	22.0	22		F	10/15/2008	Patient had pale pink macular rash on the inner aspects of both arms.  No evidence of rash, redness, swelling, or itching at site of injection which was Right upper arm.Loradamed was given.									Y	10/14/2008	10/15/2008	1	None	UNK	PVT	Unknown	None	None known			1						1	Rash erythematous; Rash macular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89973~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0328599	10/15/2008	IL	9.0	9		M	10/15/2008	Received flu vaccine in left arm by nurse.  About 5-10 minutes later was itchy and red blotches appeared on his face. Red blotches were on his forehead, cheeks, and around mouth.  He appeared pale.  He stated his throat was also itchy.  He stated trouble breathing. Parents states no previous problems with shots and no allergies. 911 called. Received oxygen and vitals were taken by paramedic.  After about 15 minutes he was getting better.  Parents did not think it was necessary for him to be taken to the hospital.									Y	10/14/2008	10/14/2008	0		PUB	PUB	No	No	No			1						1	Dyspnoea; Erythema; No reaction on previous exposure to drug; Oxygen supplementation; Pallor; Pruritus; Rash macular; Throat irritation	FLU3~SANOFI PASTEUR~U2797CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328601	10/15/2008	NC	65.0	65		F	10/15/2008	CLIENT RECEIVED INFLUENZA VACCINATION ON OCTOBER 11TH, 2008.  CLIENT REPORTS THAT SHE EXPERIENCED SYMPTOMS THAT SHE REPORTS WAS RELATED TO THE VACCINE ABOUT 1.5 HOURS LATER.  CLIENT STATES SHE EXPEREINCED  A SEVERE HEADACHE, FELT CLAMMY, AND HAD DIZZINESS AND VOMITING. CALLED EMERGENCY MEDICAL SERVICES.  BLOOD PRESSURE WAS 160/118.  TAKEN TO EMERGENCY DEPARTMENT AND RECEIVED A CT SCAN WHICH WAS NEGATIVE.  GIVEN DARVOCET FOR HEADACHE AND PAIN.				Y						10/11/2008	10/11/2008	0	CT SCAN	PUB	PVT	LYRICA, AMITRIPTYLINE, BENICA HCT, FLEXAPIN, NOVOLOG 70/30	NO	DIABETES II			1						1	Cold sweat; Computerised tomogram normal; Dizziness; Headache; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA187AA~6~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0328604	10/15/2008	GA	55.0	55		M	10/15/2008	Within 4-6 hours of the flu shot, started with high fever, muscle soreness, blurred vision, headache and lung congestion.  It lasted a good part of 24 hours.									Y	10/14/2008	10/14/2008	0	listed as percutaneous, intradermal, subQ, IM	PUB	PVT						1						1	Headache; Myalgia; Pyrexia; Respiratory tract congestion; Vision blurred	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328605	10/15/2008	MA	35.0	35		M	10/15/2008	Pt. c/o chills & pain @ injection site 4 hrs after vaccination, then noticed L axillary lymphadenopathy (grapefruit sized) approx. 8 hrs after injection. Pt took 600mg Motrin without effect. Pt to see his primary MD for follow up.									U	10/14/2008	10/14/2008	0	None	UNK	PUB	None	None	ALLEREGIES: peanuts, bees, e-mycin			1						1	Chills; Injection site pain; Lymphadenopathy	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0328606	10/15/2008	GA	54.0	54		F	10/15/2008	Hives in hairline and forehead...itchy around the eyes.  Took oral antihistamine.									Y	10/13/2008	10/14/2008	1		PVT	PVT	Clonodine, Toporol XL, Pravarastatin, Avalide, Linsinopirl,centrum Senior, Vit E, Osteobiflex, Calcium	None	Allergies to Thermisol, penicillian; hypertension; taking cholesterol medications;  5 year cancer free breast cancer			1						1	Eye pruritus; Urticaria	FLU3~SANOFI PASTEUR~Lot # U2792AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328608	10/15/2008	KY	49.0	49		F	10/15/2008	Fever 102, Chills, body aches, blurred vision, nausea, headache, swelling in throat.				Y					Y	10/14/2008	10/14/2008	0		PUB	PVT		None	None			1						1	Chills; Headache; Nausea; Pain; Pharyngeal oedema; Pyrexia; Vision blurred	FLUX~UNKNOWN MANUFACTURER~unknown~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0328609	10/15/2008	KS	69.0	69		F	10/15/2008	Within 6 hours of injection client complained of severe pain at upper right arm. At 3:00am went to ER with complaint of 10/10 pain at right arm. No redness or edema. Was admitted on observation from 3am-9:30am, 10/14/08, then discharged. Was given one Lortab for pain and blood was also drawn. Provider states blood work was WNL. By 4:00pm, 10/14, husband states she is resting with only a soreness at arm.				Y					Y	10/13/2008	10/13/2008	0	Lab was reported as WNL	PUB	PUB	Crestor, Plavix	None	No known drug allergy			1						1	Injection site pain; Laboratory test normal; Pain in extremity; Laboratory test normal; Pain in extremity	FLU3~SANOFI PASTEUR~U2761AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0814X~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U2761AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0814X~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0328612	10/15/2008	CA	34.0	34		M	10/15/2008	within one hour, felt nausea, loss of appetite.  After 4 hours, developed 102 fever, chills, vomiting, severe diaharrea, lasted several hours									Y	10/14/2008	10/14/2008	0		PVT	UNK						1						1	Anorexia; Chills; Diarrhoea; Nausea; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328615	10/15/2008	KS	21.0	21		F	10/15/2008	She experienced pain in right arm where shot was administered. Also had nausea, soreness, and numbness on R side of body. She was diagnosed with Bell's Palsy and given Medrol and Valtrex.				Y					U	10/09/2008	10/09/2008	0	none	UNK	UNK	Clindamycin HCL, Spironolactone, Prenatal Vitamins	Elevated testosterone	1. Allergies to sulfa and ceclor/ 2. High testosterone/ 3. Ear pain/ 4. Adenoidectomy and Tonsilectomy			1						1	Facial palsy; Hypoaesthesia; Injection site pain; Nausea; Pain	FLU3~SANOFI PASTEUR~U2770AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0572X~1~IM~LA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0328620	10/15/2008	FL	20.0	20		M	10/15/2008	This case was reported by a healthcare professional and described the occurrence of diaphoresis in a 20-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline).  Concurrent medical conditions included asthma and smoker.  There were no concurrent medications.  On 10 October 2008 at 10:00 the subject received a dose of FLULAVAL at 0.5 ml in the left arm.  On 10 October 2008, 45 minutes after vaccination with FLULAVAL, the subject experienced diaphoresis, chest pain, shortness of breath and fatigue.  The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention).  The subject was taken to the emergency room and treated with epinephrine.  Approximately four hours and fifteen minutes following onset, the symptoms were improved.  The health professional reported that she had five other subjects with similar, but less severe symptoms.  She did not have specific information regarding these subjects at the time of reporting.  Linked cases include: A0751890A, A0751892A, A0751893A, A0751894A and A0751895A.			Y	Y					N	10/10/2008	10/10/2008	0	UNK	PVT	PVT	No concurrent medication	Asthma; Smoker	The subject had a flu shot 4 to 6 years ago and had no reactions following that shot.  No history of adverse reactions following previous vaccinations.  The health professional reported that she had five other subjects with similar, but less severe symptoms.  She did not have specific information regarding these subjects at the time of reporting.  Linked cases include: A0751890A, A0751892A, A0751893A, A0751894A and A0751895A.		A0751880A	1						1	Chest pain; Dyspnoea; Fatigue; Hyperhidrosis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA172AA~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening	Influenza
0328621	10/15/2008	FL				U	10/15/2008	This case was reported by a healthcare professional and described the occurrence of diaphoresis in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced diaphoresis, chest pain, shortness of breath and fatigue. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. Four additional subjects had similar symptoms. Linked case include: A0751892A, A0751893A, A0751894A and A0751895A. Linked case A0751880A was more severe and included subject and event specifics.			Y						U				UNK	PVT	PVT		Unknown	Four additional subjects had similar symptoms. Linked case include: A0751892A, A0751893A, A0751894A and A0751895A. Linked case A0751880A was more severe and included subject and event specifics.		A0751890A	1						1	Chest pain; Dyspnoea; Fatigue; Hyperhidrosis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening	Influenza
0328622	10/15/2008	FL				U	10/15/2008	This case was reported by a healthcare professional and described the occurrence of diaphoresis in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced diaphoresis, chest pain, shortness of breath and fatigue. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. Four additional subjects had similar symptoms. Linked cases include: A0751890A, A0751893A, A0751894A and A0751895A. Linked case A0751880A was more severe and included subject and event specifics.			Y						U				UNK	PVT	PVT		Unknown	Four additional subjects had similar symptoms. Linked cases include: A0751890A, A0751893A, A0751894A and A0751895A. Linked case A0751880A was more severe and included subject and event specifics.		A0751892A	1						1	Chest pain; Dyspnoea; Fatigue; Hyperhidrosis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening	Influenza
0328623	10/15/2008	FL				U	10/15/2008	This case was reported by a healthcare professional and described the occurrence of diaphoresis in a subject of unspecified age and gender who was vaccinated with FLULAVAL, GlaxoSmithKline.  On an unspecified date the subject received unspecified dose of FLULAVAL (unknown).  At an unspecified time after vaccination with FLULAVAL, the subject experienced diaphoresis, chest pain, shortness of breath and fatigue.  The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention).  At the time of reporting the outcome of the events was unspecified.  Four additional subjects had similar symptoms.  Linked cases include: A0751890A, A0751892A, A0751894A and A0751895A.  Linked case A0751880A was more severe and included subject and event specifics.			Y						U				Unk	PVT	PVT		Unknown	Four additional subjects had similar symptoms.  Linked cases include: A0751890A, A0751892A, A0751894A and A0751895A.  Linked case A0751880A was more severe and included subject and event specifics.		A0751893A	1						1	Chest pain; Dyspnoea; Fatigue; Hyperhidrosis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening	Influenza
0328624	10/15/2008	FL				U	10/15/2008	This case was reported by a healthcare professional and described the occurrence of diaphoresis in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced diaphoresis, chest pain, shortness of breath and fatigue. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. Four additional subjects had similar symptoms. Linked cases include: A0751890A, A0751892A, A0751893A and A0751895A. Linked case A0751880A was more severe and included subject and event specifics.			Y						U				UNK	PVT	PVT		Unknown	Four additional subjects had similar symptoms. Linked cases include: A0751890A, A0751892A, A0751893A and A0751895A. Linked case A0751880A was more severe and included subject and event specifics.		A0751894A	1						1	Chest pain; Dyspnoea; Fatigue; Hyperhidrosis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening	Influenza
0328625	10/15/2008	FL				U	10/15/2008	This case was reported by a healthcare professional and described the occurrence of diaphoresis in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced diaphoresis, chest pain, shortness of breath and fatigue. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. Four additional subjects had similar symptoms. Linked cases include: A0751890A, A0751892A, A0751893A and A0751894A. Linked case A0751880A was more severe and included subject and event specifics.			Y						U				Unk	PVT	PVT		Unknown	Four additional subjects had similar symptoms.  Linked cases include: A0751890A, A0751892A, A0751893A and A0751894A.  Linked case A0751880A was more severe and included subject and event specifics.		A0751895A	1						1	Chest pain; Dyspnoea; Fatigue; Hyperhidrosis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening	Influenza
0328631	10/15/2008	VA	62.0	62		F	10/09/2008	Anaphylactic shock following administration of flu vaccine at physician's office. Patient became diaphoretic, hypotensive following injection. Sent to ER, where she received epinephrine and methylprednisolone with some improvement. Complaints of coughing and wheezing. BP again dropped, retreated with epinephrine and steroid. Admitted to ICU. 10/22/08-records received for DOS 10/7-10/10/08- DC DX: Anaphylactic shock to flu shot. Presented to ED with after becoming diaphoretic, hypotensive following flu shot. C/O cough and wheezing. Blood pressure dropped to 60/40.			Y		Y	3			Y	10/07/2008	10/07/2008	0	Initial O2 sat =89 10/22/08-records received-EKG-unremarkable with borderline 1st degree AV block. CT scan of head unremarkable. Chest x-ray unremarkable. CT scan of brain unremarkable. CBC white blood cell count 22.1. Potassium 3.2, Magnesium 1.7, Cardiac isoenzymes unremarkable. Blood culture no growth. Echocardiogram mild pulmonary hypertension.	UNK	UNK			Allergies: VIOXX; Iodine; Latex; Tetanus. PMH: COPD, arthritis, hypertension, anxiety, depression  10/22/08-records received- PMH:COPD, arthritis, hypertension, anxiety and depression.			1						1	Anaphylactic shock; Blood pressure decreased; Cough; Hyperhidrosis; Intensive care; Oxygen saturation decreased; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA187AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening,Hospitalisation	Influenza
0328632	10/15/2008	PA	58.0	58		F	10/13/2008	Patient received flu and pneumonia vaccine at our pharmacy flu clinic on 10/11/08 from me. The patient states that Saturday evening she started to feel very warm and fatigued. She ran a temperature of approximately 103 F and took four 200mg tablets of ibuprofen. She has continued to take ibuprofen daily because her arm is still very sore, red, and warm to the touch. To her knowledge she has not continued to run a fever but her arm is still bothering her she is still feeling fatigued.									Y	10/11/2008	10/11/2008	0		UNK	UNK			Allergies: Penicillin and ACE Inhibitors; Preexisting Disease States: Lupus and Hypertension			1						1	Body temperature increased; Erythema; Fatigue; Feeling hot; Pain in extremity; Skin warm; Cellulitis; Erythema; Pyrexia; Rash; Skin warm; Swelling	PPV~MERCK & CO. INC.~0989U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~u2806aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0989u~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0328634	10/15/2008	MI	65.0	65		F	10/14/2008	Patient woke up with hives and itching. Says she gets hives about once a year, but this was from the zoster vaccine. Took some BENADRYL. The hives she gets once a year go away with BENADRYL and sometimes needs prednisone.									U	10/14/2008	10/14/2008	0	None	OTH	PVT	Unknown	None	Penicillin allergy			1						1	Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA271AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|VARZOS~MERCK & CO. INC.~1214X~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0328635	10/15/2008	KS	22.0	22		F	10/15/2008	-Chest tightness approximately 45 minutes after vaccine. -Received 0.30 ml Epinephrine 1:1000, 14:22 PM. -Symptoms improved 14:30 PM. -Seen by provider 15:15 PM. -Prednisone tapering dose prescribed.				Y					Y	10/14/2008	10/14/2008	0		OTH	OTH	PAXIL; XANAX; CLARITIN; SINGULAIR; OCP	None known	Seasonal allergies; anxiety and depression			1						1	Chest discomfort	FLU3~SANOFI PASTEUR~U2768AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328637	10/15/2008	OR	68.0	68		F	10/14/2008	Patient was given vaccine around 10:00 am and developed nausea, diarrhea and vomiting in the afternoon. Those symptoms resolved by the next morning.				Y					Y	10/13/2008	10/13/2008	0		OTH	OTH						1						1	Diarrhoea; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328638	10/15/2008	OH	44.0	44		F	10/15/2008	Approx. 24 hr after vaccination, developed congested cough, sore throat (mild) and mild ear ache; followed by profound bone pain in long bones (humerus x 2 femurs x 2 tibias x 2).									Y	10/03/2008	10/04/2008	1	None	PUB	UNK	Tenoratic, Omega 3, ASA, B complex	None	HTN			1						1	Bone pain; Cough; Ear pain; Pharyngolaryngeal pain; Respiratory tract congestion	FLU3~SANOFI PASTEUR~U2771AA~3~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328639	10/15/2008	MI	31.0			F	10/15/2008	Tingling/numbness in right arm where injection given (patient states PNEUMOVAX given in right arm).				Y					U					OTH	OTH			Hay fever; migraine			1						1	Injection site anaesthesia; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881132P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1382U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0328640	10/15/2008	AZ	78.0	78		F	10/15/2008	Patient received ZOSTAVAX on 10/8/08. 2 days later - 10/10/08 she developed a rash on her thighs - no shortness of breath or other adverse reaction. On 10/13/08 she noticed a rash on her arms. She went into her hot tub and felt like her arms were on fire. burning, today - better									U	10/08/2008	10/10/2008	2		OTH	PVT	FOSAMAX, SIMVASTATIN	None	Hyperlipidemia, Osteopenia			1						1	Burning sensation; Rash; Erythema; Rash pruritic	FLU3~SANOFI PASTEUR~U2809AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~1207X~1~IM~LA~ZOSTER LIVE (ZOSTAVAX)~1|FLU3~SANOFI PASTEUR~U2809AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|VARZOS~MERCK & CO. INC.~1207X~UNK~UN~UN~ZOSTER LIVE (ZOSTAVAX)~2	USA		Influenza
0328641	10/15/2008	MO	82.0	82		F	10/11/2008	Patient experienced extreme dizziness about 36 hours after receiving shot. In addition, she stated she just didn't feel 100% all over, dizziness was somewhat better on day 4; and she was starting to feel like herself again by day 5.									Y	10/06/2008	10/07/2008	1		OTH	PVT	FOSAMAX; PLAVIX; NORVASC	None	Bronchial disease			1						1	Dizziness; Malaise	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0328643	10/15/2008	MI	8.0	8		M	10/15/2008	Approximately 1 1/2 hours after patient received FLUVIRIN he broke out in hives. I told mom to give him BENADRYL and keep an eye on him. Take to ER if trouble breathing. BENADRYL helped and hives were gone within a few hours.									Y	10/14/2008	10/14/2008	0		OTH	PVT						1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88637~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0328644	10/15/2008	MN	4.0	4		M	10/15/2008	Right deltoid redness at injection sight measuring 9.5 cm vertically, 11 cm horizontal									Y	10/13/2008	10/15/2008	2		PVT	UNK	None	None	None			1						1	Injection site erythema	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B064AA~5~IM~RA~DTAP (INFANRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500557P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~A0836~4~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0865U~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0999X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0328645	10/15/2008	CA	24.0	24		F	10/15/2008	4 CM erythema at inj site (R upper arm) with tenderness/warmth/swelling. Rec observation/ice/motrin prn.									U	10/14/2008	10/15/2008	1		PUB	UNK						1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2758AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328646	10/15/2008	PA	6.0	6		U	10/15/2008	Warm to touch area of redness 5 in x 4.5 in. Areas of swelling 4 in x 4 in. Prescribed BENADRYL 12.5 ml/5 cc				Y						10/13/2008	10/14/2008	1		PVT	PUB		None	None			1						1	Erythema; Skin warm; Swelling	FLU3~SANOFI PASTEUR~U2828AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328650	10/15/2008	WV	50.0	50		F	10/15/2008	Oct. 3 - vaccine given hurt on shoulders, Right side of neck									N	10/03/2008	10/04/2008	1		PUB	UNK	DIABETES - BP - CHOLESTEROL - BLOOD THINNER	No	No			1						1	Musculoskeletal pain; Neck pain	FLU3~SANOFI PASTEUR~U2271AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328651	10/15/2008	KS	45.0	45		F	10/15/2008	Client contacted health department to report extreme pain in (L) upper extremity with numbness; client also states that she had passed out secondary to extreme pain. Client had received PNEUMOVAX vaccine 10/14/08. Client was instructed and present to the medical clinic to be observed by her primary care provider. Client called HD @ 8:30 AM. Client was scheduled in clinic @ 8:45.				Y					U	10/14/2008	10/15/2008	1		PUB	PVT		None	None			1						1	Hypoaesthesia; Loss of consciousness; Pain in extremity	FLUN3~MEDIMMUNE VACCINES, INC.~500543P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|PPV~MERCK & CO. INC.~0867X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0328652	10/15/2008	GA	57.0	57		F	10/14/2008	HIVES, ITCHY THROAT, PUFFY FACE - 1 hour after receiving vaccine. Previous flu vaccine 10/07. Went to ER - given1m BENEDRYL and then recovered and went back to work.				Y					Y	10/10/2008	10/10/2008	0		PUB	UNK	None	None	Lupus, HTN			1						1	Swelling face; Throat irritation; Urticaria	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328673	10/15/2008	CA	4.0			M	09/05/2008	A non-serious spontaneous report of wheezing and fever has been received from a nurse concerning a four-year-old male subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient had no history of wheezing. The patient received the first dose of FLUMIST on 01-Sep-2008. Approximately nine to ten hours after receiving FLUMIST, the patient developed a fever and wheezing. The patient was given acetaminophen. The outcome was not reported.									U	09/03/2008	09/03/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007105	1						1	Pyrexia; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~S004540~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0328674	10/15/2008	MO	58.0			M	09/11/2008	A non-serious spontaneous report of given expired vaccine was received from a registered nurse concerning a 58-month-old male. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received his first dose of FluMist on 11-Sep-2008. The FluMist had expired on 03-Apr-2008. The reporter stated that FluMist was given by one of the nurses helping out the clinic on 11-Sep-2008 and not by the nurse in-charge of the immunization. the incident regarding the expired FluMist was noted when the immunization record was being updated. As of 24-Sep-2008, there was no adverse event reported; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the vent is considered resolved. 09/11/2008 Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information received on 24-Mar-2009 included Product Complaint Investigation results.									Y	09/11/2008	09/11/2008	0		PUB	OTH	Concomitant drug(s) not reported.				MEDI0007117	1						1	Expired drug administered; Inappropriate schedule of drug administration; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500500P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0328675	10/15/2008	NY	1.7			M	09/15/2008	A non-serious spontaneous report of a 20-month-old male child who was administered FluMist, and developed runny nose and fever had been received from a consumer. This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Medical history and concomitant medications were not reported. The patient received FluMist on 11-Sep-2008. On 12-Sep-2008, the patient developed a runny nose, and on 14-Sep-2008, eh developed a fever of 101 degrees Fahrenheit. The outcome of the events was not reported.									U	09/11/2008	09/11/2008	0		OTH	OTH	Concomitant Drug(s) not reported.				MEDI0007123	1						1	Inappropriate schedule of drug administration; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0328676	10/15/2008	WA				U	09/15/2008	A non serious spontaneous report of inadvertent administration of expired FLUMIST was received from a nurse concerning a patient of unknown age in a pediatrician's office. This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. There was no adverse event associated with this medication error at the time of the report, nor when contact was made with the site approximately two weeks later; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. 10/07/08 Follow-up received 07-Oct-2008: No adverse events had been reported. Follow-up information received on 20-Mar-2009 included Product Complaint Investigation results.									Y	09/07/2008	09/07/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007125	1						1	Expired drug administered; Medication error; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500479P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0328678	10/15/2008	WA				U	09/15/2008	A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a nurse concerning a patient of unknown age in a pediatrician's office. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. There was no adverse event associated with this medication error at the time of the report, nor when contact was made with the site approximately two weeks later; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medications errors that occurred shortly after the product expired. Follow-up received 07-Oct-2008. No adverse events had been reported. Follow-up received 20 Mar-2009: added product complaint investigation results.									Y	09/01/2008	09/01/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007126	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500479P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0328679	10/15/2008	WA				U	09/15/2008	A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a nurse concerning a patient of unknown age in a pediatricians office. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Follow-up received 17-Oct-2008. No adverse events had been reported. Follow-up information received on 20-Mar-2009 included Product Complaint Investigation results.									Y	09/01/2008	09/01/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007127	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500479P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0328682	10/15/2008	WA				U	09/15/2008	A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a nurse in the USA concerning a patient of unknown age in a pediatrician's office. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up received 17-Oct-2008. no adverse events had been reported. Follow-up information received on 20-Mar-2009 included Product Complaint Investigation results.									Y	09/01/2008	09/01/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007128	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500479P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0328684	10/15/2008	WA				U	09/15/2008	A non-serious spontaneous report of inadvertent administration of expired flumist was received from a nurse concerning a patient of unknown age in a pediatrician's office. This case is submitted in accordance with MedImmune  post-market commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. There was no adverse event associated with this medication error at the time of the report, nor when contact was made with the site approximately two weeks later, therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication error were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occured shortly after the product expired. Follow-up received 07-Oct-2008. No adverse events had been reported. Follow-up information received on 20-Mar-2009 included Product Complaint Investigation results.									Y	09/01/2008	09/01/2008	0		OTH	OTH	Concomitant Drug(s) not reported				MEDI0007129	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500479P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0328693	10/15/2008	WA				U	09/15/2008	A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a nurse concerning a patient of unknown age in a pediatricians office. This case is submitted in accordance with Medimmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. There was no adverse event associated with this medication error at the time of the report, nor when contact was made with the site approximately two weeks later, therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up received on 17-Oct-2008. No adverse events had been reported. Follow-up information received on 20-Mar-2009 included Product Compliant Invetigation Products.									Y	09/01/2008	09/01/2008	0		OTH	OTH	Concomitant Drug (s) not reported				MEDI0007130	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500479P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0328694	10/15/2008	WA				U	09/15/2008	A non-serious spontaneous report of inadvertent administration of expired Flumist was received from a nurse concerning a patient of unknown age in a pediatrician's office. This case is submitted in accordance with Medimmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. There was no adverse event associated with this medication error at the time of the report, nor when contact was made with the site approximately two weeks later; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medications errors that occurred shortly after the product expired. Follow-up received 07-Oct-2008. No adverse events had been reported. Follow-up information received on 20 Mar-2009 included Product Complaint Investigation results.									Y	09/01/2008	09/01/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007131	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500479P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0328695	10/15/2008	WA				U	09/15/2008	A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a nurse concerning a patient of unknown age in a pediatricians office. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. There was no adverse event associated with this medication error at the time of the report, when contact was made with the site approximately two weeks later; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the real cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up received 02-Oct-2008: No adverse events had been reported. Follow-up information received on 20-Mar-2009 included Product Complaint Investigative results. 10/07/08 Follow-up received 07-Oct-2008: No adverse events had been reported.									Y	09/01/2008	09/01/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007132	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500479P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0328696	10/15/2008	WA				U	09/15/2008	A non-serious spontaneous report of inadvertent administration of expired FluMist was received from a nurse concerning a patient of unknown age in a pediatricians office.  This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Follow-up received 07-Oct-2000. No adverse event had been reported. Based on the results of the investigation, the root cause for the medication were caused by 1) customer not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occuured shortly after teh product expired. Follow-up received 30-Mar-2000: added product complaint investigation results.									Y	09/01/2008	09/01/2008	0		OTH	OTH	Concomitant drug(s) not reported				MEDI0007133	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500479P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0328697	10/15/2008	OH	1.9			U	09/23/2008	A non-serious spontaneous report of FLUMIST was received from a mother in the USA concerning a 23-month-old patient who received FLUMIST.  This case is submitted in accordance with organization's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  The patient's medical history and concomitant medications were not reported.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y					OTH	OTH	Concomitant drug (s) not reported				MEDI0007151	1						1	Inappropriate schedule of drug administration; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0328698	10/15/2008	MD	0.9			M	09/30/2008	A non-serious, spontaneous report of administration of FLUMIST to a nine-month-old male infant was received from a physician. The patient's medical history includes seizures and developmental delay. Concomitant medications included Phenobarbital and oral steroids. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments not applicable and the event is considered resolved. This case is submitted in accordance with agencies post-mareketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.									Y	09/30/2008	09/30/2008	0		PVT	OTH	oral steroids; phenobarbital	Seizures; Developmental delay			MEDI0007165	1						1	Inappropriate schedule of drug administration; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500584P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0328699	10/15/2008	DC	0.58	0	.6	F	09/30/2008	A non-serious, spontaneous report of FLUMIST vaccine inadvertently administered to a seven-month-old female was received from a nurse.  This case is submitted in accordance with organization's post-marketing commitment on accelerated reporting for the newly indicated population of 7 years to 59 months of age for FLUMIST.  Concomitant medications include Hib vaccination.  The patient had no known allergies.  There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmunes post - marketing comitment on accelerated reporting for the newly indicated population of 2 years to 56 months of age for FLUMIST.									Y	09/29/2008	09/29/2008	0		PUB	OTH	Concomitant Drug(s) Not Reported		Gestational age, 41 weeks		MEDI0007166	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~IN500547P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HIBV~UNKNOWN MANUFACTURER~~UNK~UN~UN~HIB (NO BRAND NAME)~1	USA		Influenza
0328700	10/15/2008		3.0			U	09/01/2008	A non-serious spontaneous report of blisters on mouth was received from a physician's office concerning a three-year-old subsequent to FLUMIST.  This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  Neither relevant medical history nor concomitant medications was reported for this patient.  The patient received FLUMIST for the first time and Hep A for the second time.  Twenty-four hours after receiving FLUMIST and Hep A, the patient developed blisters on mouth.  After the office had further discussion with the toddler's mother, it was discovered that the child has had blisters around the mouth on several different occasions and it was probably no related to vaccines.  The outcome of the adverse events was not reported.  Additional dosing with FLUMIST was not reported.  The adverse event of blisters on mouth was reported as probably not related to FLUMIST.									U					OTH	OTH	Concomitant Drug(s) Not Reported		None		MEDI0007096	1						1	Condition aggravated; Oropharyngeal blistering	FLUN3~MEDIMMUNE VACCINES, INC.~~1~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~UNKNOWN MANUFACTURER~~2~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0328701	10/15/2008	TX				U		A non-serious spontaneous report of asthma attack was received from a Allergist's office concerning a child subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient has a history of asthma. No concomitant medications were reported for this patient. The patient received FLUMIST for the first time. Twenty-four to forty-eight hours after receiving FLUMIST< the patient was seen in the emergency room for an asthma related event. The child was treated, stabilized and released from the emergency room. The final outcome of the adverse event was not reported. Additional dosing with FLUMIST was not reported. The causality for asthma attack to FLUMIST was not reported.									U		09/03/2008			UNK	UNK	Concomitant Drug(s) Not Reported	Asthma			MEDI0007100	1						1	Asthma; Condition aggravated	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0328702	10/15/2008	MD	4.0			M	09/03/2008	A Non-Serious Spontaneous report of HEADACHE has been received from a consumer concerning a four-year old male patient subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 02Sep-2008. The patient's parents reported that approximately six hours after FLUMIST administration, the patient experienced headache that lasted 10-12 hours into the night. The patient was given pain relievers with no relief. The outcome of the adverse event is resolved. The event resolved in the early morning hours.									Y	09/02/2008	09/02/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007101	1						1	Headache	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0328703	10/15/2008	MN	3.0	3		F	09/19/2008	A non-serious spontaneous report of hives, intermittent rash, and hips and shins hurting has been received from a physician in the USA concerning a three year old female.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  The patient had no known allergies and no relevant medical history.  There was no concomitant medication.  On 03-Sep-2008, The patient received FLUMIST, intranasal administration for flu immunization at approximately 11:00am.  The patient received no prior doses.   Approximately eight hours after FLUMIST administration on 03 Sep 2008,  the patient developed an intermittent rash and hives were on that broke out 5 times throughout that night and would come and go.  The rash and hives were on the patient's face, abdomen, and back, not on her arms or legs.  The hives were described as raised lesions the size of mosquito bites with pale centers and they itched.  The patient had no swelling, no trouble breathing, and no other symptoms.  She was treated with oral BENADRYL and seen in the office on 04-Sep-2008.  The rash and hives had improved.  The patient's mother called the physician's office on 10-Sep-2008 and reported she had stopped BENADRYL because the rash and hives went away but they subsequently came back.  She also reported the patient's hips and shins were hurting on 09-Sep-2008 but that stopped the following day.  The physician told the patient's mother  to continue oral BENADRYL because the hives could last up to 3 weeks and start TYLENOL for discomfort.  The patient recovered from the hips and shins hurting and as of the last phone call from the patient's mother to the physician on 10-Sep-2008.   The hives and intermittent rash were ongoing.  Additional information was received on 19-Sep-2008 and incorporated into the above narrative which included reporter information, vaccine information, additional events, and event outcomes.									Y	09/03/2008	09/03/2008	0		PVT	OTH	Concomitant Drug(s) Not Used				MEDI0007103	1						1	Arthralgia; Pain in extremity; Rash; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~IN500540P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0328890	10/15/2008	AZ	13.0	13		F	10/08/2008	Information has been received from a physician concerning a 13 year old female with a history of scoliosis (status post surgery) who on 28-AUG-2008 was vaccinated with an unspecified dose of GARDASIL (lot # 660612/0229X) in the left upper arm.  Concomitant therapy included FLUZONE.  At 4:00 PM, the patient went to the lobby after receiving her GARDASIL and FLUZONE  shots, she was standing at the front desk and collapsed.  She was unconscious for a few minutes and then woke up.  Normal mental status when woke up except that she was upset.  Additional information is not expected.									Y	08/28/2008	08/28/2008	0		PVT	PUB			Scoliosis		WAES0809USA01058	1						1	Emotional distress; Loss of consciousness; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~0229X~UNK~UN~UN~HPV (GARDASIL)~1	USA		Influenza
0328632	10/16/2008	PA	58.0	58		F	10/16/2008	Patient stated she began to feel feverish the evening after receiving the vaccine and had a fever of approximately 103 F. She took four 200mg ibuprofen for the fever the evening of 10/11/08 and it persisted until Sunday evening. As of Monday morning at 11am she had take 3 more doses of ibuprofen since the original. Patient also has what appears to be cellulitis, rash that is very warm to the touch, swollen and red. She was going to consult with he physician on 10/13/08 or 10/14/08. We are making a follow-up call tomorrow 10/17/08 to see what progress was made with the patient.									U	10/11/2008	10/11/2008	0		PUB	PVT	Metoprolol 50mg	None known	Pre-existing Medical Conditions: Lupus & Hypertension        Allergies: Penicillin & ACE Inhibitors			1						2	Body temperature increased; Erythema; Fatigue; Feeling hot; Pain in extremity; Skin warm; Cellulitis; Erythema; Pyrexia; Rash; Skin warm; Swelling	PPV~MERCK & CO. INC.~0989U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~u2806aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0989u~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0328658	10/16/2008	VA	46.0	46		F	10/16/2008	45 min after injection, rash and later hives. Was seen and treated by PCP, BENADRYL IM, XYCAL 5mg BID and PREDNISONE dose pack.				Y					Y	10/13/2008	10/13/2008	0	None	PUB	PVT	None	None	None			1						1	Rash; Urticaria	FLU3~CSL LIMITED~02249111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0328660	10/16/2008	NJ	37.0	37		F	10/16/2008	3 AM - woke with itching, rash noted on elbow spread to legs, trunk, arms, head progressed to hives				Y					Y	10/08/2008	10/09/2008	1	Seeing Allergist	PVT	OTH		None reported	None reported			1						1	Pruritus; Rash; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLA358AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0328661	10/16/2008	CO	4.0	4		M	10/09/2008	R arm indurated, erythematous, painful, hot. Cellulitis vs Severe local reaction. TX: KEFLEX, BENADRYL, MOTRIN, ice.				Y					U	10/08/2008	10/08/2008	0	Clinical only	PUB	PUB		None	Asthma			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~1025~3~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328662	10/16/2008	PA	25.0	25		F		C/O sudden onset of dizziness and nausea, resolved over time. Immunization site red, raised, warm. Approx. 1 x 2 area, painful. Took 25 mg oral BENADRYL @ 4:45 PM.									Y	10/08/2008	10/08/2008	0		PUB	PVT	PAMELOR; Cranberry Supplement	Denies	Migraines headaches			1						1	Dizziness; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA350AB~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0328663	10/16/2008	NC	4.0	4		F	10/08/2008	Developed hives within hours of receiving FLUMIST. Mother gave BENADRYL, child did fine.									Y	10/06/2008	10/06/2008	0	None	PVT	PUB		No	Food Allergies to eggs, milk			1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500548P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0328664	10/16/2008	IL	57.0	57		F	10/13/2008	Rash around injection site.									U	10/08/2008	10/13/2008	5		OTH	OTH		None	None			1						1	Injection site rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0061U~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328666	10/16/2008	CA	2.0	2	1	M	10/09/2008	None. I ordered and patient received 0.5 ml flu vaccine, but should have received 0.25 ml flu vaccine as was still < 3 years old.									Y	10/09/2008				PVT	PVT	None	Upper respiratory tract infection	Asymmetric chest wall			1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~U2786BA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328667	10/16/2008	CA	78.0	78		F	10/12/2008	About five minutes after shot, pt was talking and moving around with her walker. Pt said she felt nauseated and that her pulse and heart were racing. It was only after shot that even though I asked her if previous Rxn to shot that she said that she had problems with it. Pt allergic to EPI, so we took her BP/Pulse, it was high. She rested for about 20 mins and took some ASA, and she was fine when she left.									Y	10/12/2008	10/12/2008	0	Gave ASA, 81 mg, at 1:48 PM; 1:47 PM, BP, 188/106; Pulse, 100; 1:58 PM, BP, 166/98; Pulse, 59; 2:04, BP, 163/83; Pulse, 60; 2:15, BP, 162/79; Pulse, 57	PUB	OTH	Unknown/ASA	None/ heart stent	Heart stent; arthritis-general. Pt's daughter gave me a list of pt's allergies. They are as follows, along with the Rxn to agent: epinephrine - pt faints; paraban - illness and extreme raw rash; sulfa/PCN - unspecified; CIPRO - SOB and increase in pulse; MACROBID - rash and BP decrease; Clindamycin - unspecified; XANAX - BP decrease with one dose; VIOXX - dizziness; MOBIC - throat closed; ARTHROTEC - general pain overall increase; ACIPHEX - nausea and brown urine/loose stool; RELAFEN - pain increase; NEXIUM - rash/nausea; PREVACID - rash; KENALOG - fainted.			1						1	Blood pressure increased; Heart rate increased; Nausea; Palpitations	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0328668	10/16/2008	CA	71.0	71		F		Patient received the flu shot, and about 10 AM on Thursday, Oct. 9 2008, she claims she developed sore throat at 1 AM next day with swelling on the left cheek. She went to local hospital and was given oral BENADRYL, and she was released after evaluated.				Y					Y	10/09/2008	10/09/2008	0		OTH	PVT		None Known	Patient claimed to have shown allergy to LIPITOR			1						1	Oropharyngeal pain; Swelling face	FLU3~SANOFI PASTEUR~U2848AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328752	10/16/2008	TN	14.0	14		M	10/16/2008	Patient evidenced hoarseness and nasal drainage in late morning hours on 10-15-2008.  Hoarseness worsened throughout the day and continued into the next day (the day this report was submitted.)Future prognosis unknown.									N	10/14/2008	10/15/2008	1		PVT	PVT	None	None noted	Asthmatic , allergic to sulfa, hydrocodiene, tree pollens, mold, mildew, dust.	edema, knot, pain, reddness at injection site - injection site was inflamed from shoulder to 1-inch above elbow and 2 inches on 		1						1	Dysphonia; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328754	10/16/2008	IL	0.75	0	.8	M	10/16/2008	Gave adult formulation FluLaval 0.25ml to 9 mo. old.  Mother notified of mistake 10-16-08, reports no adverse reaction.  Slight runny nose and slight fever today (10-16-08).									Y	10/14/2008				PUB	PVT	none	none	none			1						1	Incorrect dose administered; Pyrexia; Rhinorrhoea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA165AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0328755	10/16/2008	NJ	50.0	50		F	10/16/2008	Blurred vision cause by mucas like substance in eyes.  Tightness in throat and chest, coughing, fatigue, body aches. dizziness, light headed I took 2 benedryl									Y	10/15/2008	10/15/2008	0	none	PUB	PUB	lipitor	none	none			1						1	Chest discomfort; Cough; Dizziness; Eye discharge; Fatigue; Pain; Throat tightness; Vision blurred	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328756	10/16/2008	NY	67.0	67		M	10/16/2008	ASTMA ATTACK.  COULDN'T BREATHE NORMALLY.  SORE THROAT.  SORE ARM AT INJECTION SITE.			Y						Y	10/15/2008	10/15/2008	0		UNK	PUB						1						1	Asthma; Dyspnoea; Injection site pain; Pharyngolaryngeal pain	FLU3~SANOFI PASTEUR~U2828ad~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0328757	10/16/2008	NC	3.0	3		M	10/16/2008	EDEMA FROM SHOULDER TO ELBOW, RED, TENSE, NONTENDER TO GENTLE TOUCH.				Y					Y	10/13/2008	10/14/2008	1		PVT	PUB	none	URI, wheezing, cough	pulmacort			1						1	Injection site erythema; Injection site induration; Injection site oedema	FLU3~SANOFI PASTEUR~u2795ea~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328758	10/16/2008	NY	79.0	79		F	10/16/2008	Hospitalized from 10/12/08 to 10/15/08 for new onset atrial fibrillation, which resolved itself. According to patient there was no treatment and during her hospitalization she was offered flu immunization (admitting physician was unaware she had already received it).					Y	4			Y	10/06/2008	10/12/2008	6		UNK	PVT	unknown	None	unknown			1						1	Atrial fibrillation; Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U2771AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0328759	10/16/2008	MD	51.0	51		F	10/16/2008	almost immediately after recieving the shot I noticed pain in my arm and shoulder, not stiffness...pain. Throughout the afternoon it worsened, coming in waves and throbbing.  I took extra strength Tylenol. No relief. About 5:00 I began to feel slightly feverish, congested with a headache. After having had these shots every year, I did not relate these symptoms to the shot. The painful arm was an obvious reaction. Later in the evening, I became nauseated, pale and clammy. I did vomit once. Applied a cool compress and went to bed. Today, the arm pain is still evident, however not as severe. The nausea is faint and I have a nasty taste in my mouth.    I wanted to make you aware of the reaction in the event that I was not alone and this could possibly be related to the batch that was asministered. Please contact me if necessary.									U	10/15/2008	10/15/2008	0		UNK	UNK	Wellbutrin	None	n/a			1						1	Cold sweat; Dysgeusia; Headache; Musculoskeletal pain; Nausea; Pain; Pain in extremity; Pallor; Pyrexia; Respiratory tract congestion; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328760	10/16/2008	AL	60.0	60		F	10/16/2008	Shortly after receiving the flu shot, I had some itching.  fter arriving hom I was itching all over and started to have some red spots which itched.  after waking up I had hives, not a lot but some on my arms, head legs and stomach.										10/15/2008	10/16/2008	1		PVT	PVT						1						1	Pruritus generalised; Rash pruritic; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328761	10/16/2008	MD	60.0	60		F	10/16/2008	Developed a rash/hives at site area of injection the next day. Rash/hives in area near injection were blotchy, somewhat raised and itchy. Subsided third day and about gone on fourth day.									Y	10/13/2008	10/14/2008	1		UNK	UNK	Levothyroxine,Lovaza	none	Shrimp allergy, Pollen, dust.			1						1	Injection site pruritus; Injection site rash; Injection site urticaria; Rash macular	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328765	10/16/2008	WY	45.0	42		F	10/16/2008	She noticed on 10-12-08 her arm was red and swollen. She presented to our office on 10-13 with a reddened,oval shaped 4cmx7cm, indurated and warm area on her right arm 3 above her elbow.  The puncture site from the injection obvious. The shot was not given in the deltoid.  She was started on Augmentin. She was seen in follow uo on 10-14.				Y					U	10/11/2008	10/12/2008	1		UNK	UNK	Altace 10mg -Pravachol 80mg -maxzide3705/25mg - levothyroxine 50mcg - Glucophage ER - Humulin 70/30	None	IDDM-not controlled -Dyslipidemia- Hypothyroid			1						1	Erythema; Induration; Oedema peripheral; Skin warm	FLUX~UNKNOWN MANUFACTURER~unknown~UNK~SC~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0328766	10/16/2008	TN	23.0	23		F	10/16/2008	Vasovagal syncope with subsequent fall hitting head; rapid return of consciousness.  BP 86/70, pulse palpated as low as 40.  ECG - HR = 55.  Pulse ox = 98%.									Y	10/16/2008	10/16/2008	0	ECG, pulse oximetry; 2D-echocardiogram scheduled	PVT	PVT	Ortho-Tri-Cyclen Lo	No	Sulfa allergy			1						1	Electrocardiogram; Fall; Head injury; Heart rate decreased; Oxygen saturation; Syncope vasovagal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA158AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|HPV4~MERCK & CO. INC.~0571X~3~IM~RA~HPV (GARDASIL)~1	USA		Influenza
0328769	10/16/2008	TX	13.0	13		F	10/16/2008	Client received HPV #1 vaccine on right upper arm approximately at 5:15pm in company of her mother. Mother during assessment stated she had eaten goodies prior to vaccine and was ready to receive her shot although she appeared nervous. After informing patient/parent of the benefits of the vaccine and comfort measures, she stated she was ready for shot. Approximately 2 minutes after administration, patient stated she didn't feel good and sat on her mother's lap. She leaned towards her mother resting her head on mother's chest. I'll be alright, I just need some time she added that she felt weak and needed to sit down on chair.  She stood up and with my assistance she proceeded to sit in chair. I questioned mother on her pale color, to which she answered that it was her normal color, she was always pale. Vital signs taken excluding temperature. P-66, R-12, B/P 108/80.  Patient called on cell phone initiating a conversation. Mother stated she was fine and they needed to go, signing Vaers form that she could no longer stay. Patient left ambulating in company of mother and sister at approximately at 6:00 pm.									Y	10/15/2008	10/15/2008	0	none	UNK	UNK	none	none	none			1						1	Asthenia; Feeling abnormal; Heart rate normal; Pallor	FLU3~SANOFI PASTEUR~U2791BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~M0072X~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2658AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B027AA~1~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0328770	10/16/2008	OH	1.7	1	.7	F	10/16/2008	PHN administered 0.5cc (incorrect dosage) of the influenza vaccine to patient who is 20 months old. Patient had primary series of the influenza vaccine last year. No tx. was needed at this time. PHN informed mother that an error had occurred. PHN gave mother a VIS information sheet and s/s were reviewed for observation.									U	10/16/2008				UNK	UNK	None	No	None			1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~U2768AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB243AA~2~IM~RL~HEP A (HAVRIX)~1	USA		Influenza
0328772	10/16/2008	IN	42.0	42		M	10/16/2008	Headache, fever, cough, sinus drainage, body ache				Y					Y	10/04/2008	10/05/2008	1	NONE	MIL	MIL	NONE	NONE	sinucitis			1						1	Cough; Headache; Pain; Pyrexia; Sinus operation	FLUN3~MEDIMMUNE VACCINES, INC.~5005029~4~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0328773	10/16/2008	UT	76.0	76		F	10/16/2008	From shoulder to just above elbow on injection site arm was severely swollen, dark red, hot and hard, and burned and stung but did not itch. Neck, shoulder and upper back pain moderate, joint aches and stiffness moderate, severe headache, moderate chills, dizziness, and fever the prior night (10-14-08) to the point of hallucinating and sweating severely  (temp not recorded). Aches, pain, headache, fever and dizziness throughout 10-15-08. Went to ER at 9:30 pm on 10-15-08. ER doc stated he had seen other cases like this and administered 25 mgs of Benadryll and an ice pack and a precautionary RX of Bactrim but told not to fill unless family doctor recommended it. Swelling went down by morning of 10-16-08 a little bit with repeated ice applications and 37.5 mgs of Benadryll the previous night, but still significantly red just below injection site. Called Family Doctor to let them know and to get Lot#'s and information. My mother has had flu and a Pneumonia injections previously with no adverse reactions at all, not even aches or pains.				Y					Y	10/14/2008	10/15/2008	1		UNK	UNK	Zestril .05,  Clonipin .5, Previcid capsule, Aspirin	None	Mild emphysema, moderate high blood pressure, GERD, seasonal hay fever			1						1	Arthralgia; Back pain; Chills; Dizziness; Erythema; Hallucination; Headache; Hyperhidrosis; Induration; Musculoskeletal pain; Musculoskeletal stiffness; Neck pain; Oedema peripheral; Pain; Pyrexia; Skin burning sensation; Skin warm	FLU3~SANOFI PASTEUR~U2755AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1226U~7+~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0328774	10/16/2008	CA	62.0	62		F	10/16/2008	Pt reports red, raised, itchy rash began on arm of injection site, then later on right arm, then trunk and finally both legs. Did also have mild cold sx 1-2 days following injection Denies any breathing trouble. Did seek medical treatment with PCP for itching, and this has improved greatly. Some rash remains about the legs (predominant) & arms. No fever or GI sx reported.									Y	10/11/2008	10/12/2008	1		PVT	PVT		none				1						1	Nasopharyngitis; Rash erythematous; Rash pruritic	FLU3~SANOFI PASTEUR~U2757AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328775	10/16/2008	NM	23.0	23		M	10/16/2008	Approximately 5 cm area with redness, swelling, itching and soreness located in right deltoid area. No draingage or abscess present.									U	10/14/2008	10/15/2008	1	na	PUB	UNK	ocp	None	None			1						1	Erythema; Pain; Pruritus; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328777	10/16/2008	CA	11.0	11		F	10/16/2008	NONE NOTED									Y	10/15/2008	10/15/2008	0		UNK	PUB	NONE NOTED	NONE NOTED	NONE NOTED			1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U2765AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328779	10/16/2008	NC	25.0	25		F	10/16/2008	Swelling of throat, pt denies any sob, any other discomfort.				Y					Y	10/16/2008	10/16/2008	0	Angioedema	MIL	UNK		none	PCN			1						1	Angioedema; Pharyngeal oedema	FLUN3~MEDIMMUNE VACCINES, INC.~500563P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0328783	10/16/2008	CA	49.0	49		F	10/16/2008	Patient reported sudden onset of difficulty breathing, swelling in throat, rash to neck and face.				Y					Y	10/15/2008	10/15/2008	0	Pulse ox normal, EKG ST 126, normal axis, LVH, nonspecific waves. WBC 12.6	PVT	PVT		Shortness of brathness. Rash				1						1	Dyspnoea; Electrocardiogram abnormal; Oxygen saturation normal; Pharyngeal oedema; Rash; Sinus tachycardia; White blood cell count increased	FLU3~SANOFI PASTEUR~U2772AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328784	10/16/2008	CA	70.0	70		M	10/16/2008	Hives. I had the Flu shot about 1400 and saw hives about 2200. Took 2 Benadryl at 0300 and was clear of hives about 0700.									Y	10/15/2008	10/15/2008	0		MIL	MIL		none	none			1						1	Urticaria; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881294P~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0328785	10/16/2008	NJ	71.0	71		F	10/16/2008	dizziness, lightheadedness within a few minutes of receiving influenza vaccine. Pt. was instructed to stay until symptoms subsided. Given water and something to eat.									Y	10/16/2008	10/16/2008	0		PUB	PUB			diabetes, hypertension	dizziness, lightheadedness~Influenza (Seasonal) (no brand name)~NULL~~In Patient		1						1	Dizziness	FLU3~SANOFI PASTEUR~U2769AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328787	10/16/2008	TX	31.0	31		M	10/16/2008	Aprroximate 1-2 hours after vaccination given: The vaccination was given roughly around 11:30 am on 10/4/08. Roughly around 2:00 I was driving to a car appointment and began to feel nausea, clammy feeling, dry mouthed, felt as if I was about to faint, little dizziness. I was driving at this time coming to a stop light. Within 3-4 minutes I didn't feel so much panic as if I were going to pass out, but i felt very worn out and somewhat achy. I got to my destination within 5 minutes and ate a little food and had some water. I then took a 1 hour nap. I woke up and felt better but took it easy the rest of the day as I felt weak, achy, and just overall run down.									Y	10/04/2008	10/04/2008	0		UNK	PUB		none to report	IBS, acid reflux			1						1	Cold sweat; Dizziness; Dry mouth; Fatigue; Nausea; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89981~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0328788	10/16/2008	NC	44.0	44		F	10/16/2008	After shot received at 0830 on Oct 7,2008, arm became very sore.  That evening, had body aches.  I felt a little achy in the morning but by 11am, my back was really hurting from the rt shoulder down to the middle of my back.  Became dizzy and nauseated.  Stayed home the next day, unable to straighten up, back from mid to kidney level pain was intense.  Felt like a baseball bat was being swung at me.  By midafternoon on Thursday, I had become short of breath, unable to take a deep breath, intense back pain, dizzy, and nausea.  I had not been able to sleepdue to the pain. Unable to eat since I felt I wanted to throw up, no longer feeling the aches all over my body, just shoulder,mid and lower back.  The next morning, had increased difficulty breathing, short of breath when I talked, bent over at waist seemed to help increase air flow.  I went to Urgent care,they did an EKG, something sl abnormal.  Sent me to the ER.  EKG,chest xray, bloodwork done.  They gave me perocet that seemed to help.  They sent me home with perocet, felt it was a muscular sprain.  Sat and Sun, symptoms remained the same, just laid in bed.Perocet not working, just caused me to itch.  Monday went to my MD, intense pain on pressure on back, pushing and pulling of hands.  Pain also intense right at the sternum.  tight band around chest, unable to breath.she started me on Naprosyn and Nexiumum.  she said it was a reaction to the flu shot and added to my allergies. Tuesday, I actually felt I could get a good breath in, pain still present but decreased some.  Wednesday, I started to eat again.  Pain was better.  Thursday at present....I can stand almost straight up, still short of breath but feel I can get more air in. Voice sounds short of breath.  Pain down rt shoulder blade,across midback and down and around my rib cage.  I feel like my diaphram is not able to extend as it should. Pain level is back to an 8.  I have a call into my doctor to find out what I should do.				Y					U	10/07/2008	10/07/2008	0	chest xray, EKG, cardiac labs	PUB	UNK	lipitor, mavik, wellbutretin,paxil	none	allergies to Latex, morphine/  high cholesterol and bloodpressure.  depression			1						1	Activities of daily living impaired; Back pain; Chest X-ray; Chest discomfort; Dizziness; Dyspnoea; Electrocardiogram abnormal; Hypophagia; Laboratory test; Muscle strain; Musculoskeletal chest pain; Musculoskeletal pain; Nausea; Pain; Pain in extremity; Sleep disorder; Vaccination complication	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0328790	10/16/2008	GA	10.0	10		M	10/16/2008	redness and itching at injection site 5 minutes after receiving varivax.  Benadryl elixir 25mg given po.  Observed an additional 15 minutes.  Redness resolving.  No additional s/s noted.									Y	10/16/2008	10/16/2008	0		PUB	PUB						1						1	Injection site erythema; Injection site pruritus	FLUN3~MEDIMMUNE VACCINES, INC.~500548p~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~ahavb291ba~1~IM~LA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~0423x~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0328792	10/16/2008	NE	11.0	11		M	10/16/2008	Child given sanofi pastuer fluzone immunization on 10/10/08 at pharmacy.  Presents to our office with redness, warm to touch and hives on 10/13/08.									Y	10/10/2008	10/13/2008	3		UNK	UNK		None				1						1	Erythema; Skin warm; Urticaria	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328793	10/16/2008	FL	69.0	69		M	10/16/2008	severe pain in left elbow and muscles in upper left back. pain seems to radiate from the point of vaccination.									N	10/08/2008				UNK	UNK	none	none	none			1						1	Arthralgia; Back pain; Injection site pain; Myalgia	FLU3~SANOFI PASTEUR~U2754AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328794	10/16/2008	IL	3.0	3		F	10/16/2008	Patient developed maculopapular rash over entire body and face and extremities, along with fevers up to 104 within 24 hours of vaccine.				Y					Y	10/13/2008	10/14/2008	1		PVT	PVT						1						1	Pyrexia; Rash generalised; Rash maculo-papular	FLU3~SANOFI PASTEUR~U2786AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C80901~4~IM~LA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0328795	10/16/2008	UT	12.0	1	.0	M	10/16/2008	overlapping rings of erythema, warm, and induration. Was currently taking omnicef				Y					Y	09/30/2008	10/15/2008	15	N/A	PVT	PVT	N/A	None	None			1						1	Erythema; Induration; Skin warm	FLU3~SANOFI PASTEUR~UT2782CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB259AA~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1119X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1000X~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0328797	10/16/2008	VA	56.0	56		F	10/16/2008	Patient received influenza vaccine on 10/11/2008. (Fluzone)  Had bruising at injection site.  On 10/16/2008 came to store.  Bruise was about 2.5 inches in diameter and a small bump could be palpated at site.  Bruising had begun to resolve and the edges were yellow, to yellow-green. Bruise was not warmer than the surrounding skin.  Patient also complained of soreness in tricep.									U	10/11/2008				UNK	PVT	Simvastatin, aspirin		pineapple, metformin,hyoscyamine sulfate, dicyclomine			1						1	Injection site haematoma; Injection site mass; Myalgia	FLU3~SANOFI PASTEUR~u2741aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328807	10/16/2008	OR	46.0			F	10/16/2008	Developed wheezing and coughing, and ear pain approx. 4 hr. after getting flu vaccine. 6 hrs. after getting vaccine, she developed intensely itchy and irritated eyes. Took husband's antihistamine (allergy med) (name unknown) - improved. Next day just had headache and body aches									Y	10/15/2008	10/15/2008	0		OTH	UNK						1						1	Cough; Ear pain; Eye irritation; Eye pruritus; Headache; Pain; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA180AA~1~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0328808	10/16/2008	IL	69.0	69		M	10/16/2008	Patient had no difficulty breathing. Arm swelled. Was initially the size of a golf ball. Really hard to the touch. After 20 minutes it got smaller. Then 20 minutes later got little smaller and less hard. Gave patient 1 BENADRYL tablet.									Y	10/16/2008	10/16/2008	0		OTH	PVT			Heart condition			1						1	Induration; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0328809	10/16/2008	NE	31.0	31		F	10/16/2008	At vaccine administration, lots of bleeding and very sore. Starting 2 hours after administration, lots of itching and redness. Bruising. 9 hours later, arm numbness and tingling lips. 1 day post immunization, lots of lips and arm itching and tingling.									U	10/15/2008	10/15/2008	0		OTH	OTH	ZYRTEC- D; Vitamins; FLONASE; Oral contraceptive.		PCN; seasonal			1						1	Contusion; Erythema; Hypoaesthesia; Injection site haemorrhage; Injection site pain; Paraesthesia oral; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328810	10/16/2008	CA		70		M	10/16/2008	Swelling of arm from shoulder to elbow, very warm area around muscle. Itching. Skin is rough to touch/no treatment.									U	10/09/2008	10/10/2008	1		OTH	OTH						1						1	Dry skin; Oedema peripheral; Pruritus; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89689~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0229X~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328811	10/16/2008	CA	68.0	68		F	10/16/2008	Injection site turned red later, the same day after injection. Next morning, injection site was swollen and sore under arm. Pt couldn't lift arm without feeling pain. On appt 10/10/08, pt was still swollen a little, but could lift arm.									Y	10/08/2008	10/08/2008	0		PVT	OTH						1						1	Injected limb mobility decreased; Injection site erythema; Injection site swelling; Pain in extremity	FLU3~SANOFI PASTEUR~U2757AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0224X~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328812	10/16/2008	OR	26.0	26		F	10/16/2008	Day after injection; weak/tired - stuffy nose. Weakness increased and went home from work. Wednesday AM - Dizzy spells and felt drained Wednesday thru Saturday: Headache									Y	10/06/2008	10/07/2008	1		PVT	PVT			Allergy to Latex			1						1	Activities of daily living impaired; Asthenia; Dizziness; Fatigue; Headache; Nasal congestion	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0328814	10/16/2008	WA	51.0	51		M	10/16/2008	Depression, emotional, mental fog, unclear thinking, sadness.									N	10/09/2008				OTH	PVT						1						1	Depression; Emotional disorder; Mental impairment; Thinking abnormal	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328815	10/16/2008	NY	80.0	80		F	10/14/2008	Patient complained of edema and redness on her left arm at the injection site. Patient given KIFLEX 500 mg, BENADRYL 75 mg and nebulizer treatment.				Y					Y	10/10/2008	10/11/2008	1	LYTE - GLUC, BUN, CRTN, BCR	PVT	PVT	KDur; Multivitamin; FOSAMAX; Hydrochlorothiazide; CELEBREX; Tums; Metoprolol; ALBUTEROL in haler; Hydrocodone; Lisinopril; LIDOCAINE patch; Cholestyramine; NEURONTIN	Chronic cough for 2 weeks	mild mental retardation - cerebral palsy; Her caregiver list avoiding cortisone and steroids. They are unsure exactly why.			1						1	Blood creatinine; Blood glucose; Blood urea; Injection site erythema; Injection site oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA356BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1715UM~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0328816	10/16/2008	NY	70.0	70		F	10/16/2008	Red, warm to touch. KEFLEX, 500 mg, qid x 7 days. BENADRYL, 25-50, every 6 hours, PRN. Ibuprofen, 400 mg, every 4-6 hours, PRN.				Y					Y	09/30/2008	09/30/2008	0		PVT	OTH			HTN; Thyroid			1						1	Erythema; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA179AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0224X~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0328817	10/16/2008	CA	24.0	24		F	10/16/2008	Right and Left Deltoid red and hot at touch. States noted redness and swelling on 10/15/08 but thought it was normal. Suggested to be seen by an MD. Size 3-4 inches. redness remains on upper arm.									Y	10/14/2008	10/15/2008	1		PVT	UNK		None per patient	Breastfeeding, Thyroidism			1						1	Erythema; Oedema peripheral; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA159AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|TDAP~SANOFI PASTEUR~C2937AA~1~UN~LA~TDAP (ADACEL)~1	USA		Influenza
0328819	10/16/2008	UT	5.0	5		M	10/16/2008	RUE, started 10/16/08, AM. 6 x 6 cm, raised, pink. Slight tender, no d/c.									U	10/14/2008	10/15/2008	1	None	PVT	PVT						1						1	Erythema; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U2745AA~5~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328821	10/16/2008	PA	40.0	40		F	10/16/2008	Approximately 2 1/2 hours after vaccination, patient complained about both legs being really sore, i.e., generalized myalgia. She stated it's no big deal, and then left for lunch.									U	10/16/2008	10/16/2008	0		OTH	PVT						1						1	Myalgia; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0328822	10/16/2008	PA		65		F	10/15/2008	Felt sore in the afternoon. At 4am had pain in arm it became more hot and sore as the day progressed eventually it became bumpy, sore all around all the way to arm pit. Low grade fever 100.9 by night. Today called doctor who recommended cold compresses and Motrin for fever. Fever is down but still area is red and lumpy. Separate lumps have grouped together into one large one, feels swollen tired.									U	10/13/2008	10/13/2008	0		OTH	PUB	Omega 3 fatty acids, Vitamin C, Glucosamine sulfate.		Codeine, Dyes used in testing, Cipro, Demerol, Cholesterol depression.			1						1	Axillary pain; Fatigue; Mass; Pain; Pyrexia; Rash; Skin warm; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ATLUA359M~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0988F~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328823	10/16/2008	CA	88.0	88		F	10/15/2008	Turned cold, with chills continuously shaking in 15-20 minute intervals like convulsions. Vomited violently all over, can't move, very weak, sweaty, wet.				Y					U	10/10/2008	10/10/2008	0		UNK	UNK	Glucophage, Atenol, Digoxin, Carotene, Paxil.		Diabetes II			1						1	Asthenia; Chills; Feeling cold; Hyperhidrosis; Hypokinesia; Tremor; Vomiting	FLU3~SANOFI PASTEUR~U2755AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328824	10/16/2008	PA	42.0	42		M	10/16/2008	Little swelling at site. Redness - warm to touch, fever 102 degrees										10/14/2008	10/16/2008	2		PVT	UNK						1						1	Erythema; Injection site swelling; Pyrexia; Skin warm	FLU3~SANOFI PASTEUR~U2751AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2998BA~1~UN~LA~TDAP (ADACEL)~1	USA		Influenza
0328825	10/16/2008	OR	56.0	56		F	10/14/2008	(R) deltoid area red and warm - approx 3 - 3 1/2 radius. T. 98.6, orally. No adenopathy. Painful upper arm. Tx: symptomatic (pruritis only). F/U redness resolved in few days.				Y					Y	09/30/2008	09/30/2008	0		PVT	PVT			Allergic to SEPTRA	Redness~Influenza (Seasonal) (no brand name)~UN~0.00~In Patient		1						1	Injection site erythema; Injection site warmth; Pain in extremity; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA167AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0328826	10/16/2008	CA	5.0	5		M	10/16/2008	Left deltoid area. warmness around the sit of injection. BENADRYL 12.5/5ml, 2 tsp by mouth 96 degrees as needed, warm compress.									Y	10/13/2008	10/15/2008	2		PUB	UNK						1						1	Injection site warmth	DTAP~SANOFI PASTEUR~C2955BA~UNK~UN~RA~DTAP (DAPTACEL)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89620~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~A0805~UNK~UN~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0812X~UNK~UN~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0443X~UNK~UN~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0328827	10/16/2008	FL	58.0	66		F	10/16/2008	Stiff neck and headache, starting 1 1/2 hours after flu shot administered.				Y					N	10/15/2008	10/15/2008	0	Pt told by MD that he my have given her meningitis	OTH	OTH	CARTIA XR, Statin					1						1	Headache; Musculoskeletal stiffness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89884~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0328828	10/16/2008	WA	51.0	51		F	10/16/2008	Patient reported severe hives - all over 4 days after getting flu shot, swelling around eyes and face, minor wheezing. Hives appeared suddenly Monday evening. Resolved without treatment in 1-2 days.									Y	09/26/2008				OTH	PVT	B-12 injection, 9/29 AM, Also had eaten shellfish					1						1	Eye swelling; Swelling face; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328829	10/16/2008	CA	65.0	65		F	10/15/2008	Pt. received a FLUVIRIN vaccine on 10/13/08. On 10/15/08, approximately 12 PM, pt. stated she noticed red spots and lumps on her back, sides, and shoulders. Besides, feeling ..., the pt does not feel sick or have any difficulty with breathing. She took a CLARITIN to help with the rash and itchiness. I also advised her to apply hydrocortisone cream to the rash, if CLARITIN does not help with the itchiness.									N	10/13/2008	10/15/2008	2		OTH	PUB			Unknown			1						1	Erythema; Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA366CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0328830	10/16/2008	NV	7.0	7		M	10/16/2008	Swollen, tender and erythema around the vaccine site. Left shoulder.									U	10/15/2008	10/15/2008	0		PVT	PVT		None	None			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2803AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328799	10/17/2008	VA	33.0	33		F	10/17/2008	Large raised round welt at injection site (half again larger than a half dolalr).  Solid welt (no pus or seepage), itching, pain.									Y	10/14/2008	10/14/2008	0		PVT	PVT	Avandia, Glipizide, Byetta, Singulair, Spironolactone, Metformin	None	Diabetes, Type II, allergy to cats / sulfa / E-mycin	Large red welt~Influenza (Seasonal) (no brand name)~NULL~31.40~In Patient		1						1	Injection site pain; Injection site pruritus; Injection site urticaria	FLUX~UNKNOWN MANUFACTURER~~3~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328915	10/17/2008	CA	47.0	47		F	10/15/2008	Initial report was received 08 October 2008 from a consumer who is also the patient. A 47-year-old female patient with a history of pollen and dust allergies, had received an intramuscular left deltoid injection of FLUZONE (lot number not reported) and within two hours of vaccination (onset time not reported), she felt as if her throat was swelling, and complained of a sore raw throat, wheezing, headache, chills, a low grade fever of 99 degrees Fahrenheit, and her ears were plugged. The patient had no illness at the time of vaccination and she had not received any other vaccinations during the four weeks prior to receipt of FLUZONE. The patient self medicated with 25mg of BENADRYL and her symptoms resolved by 03:00 - 04:00am (date not reported). The patient had not been evaluated by a health care professional for the event. Concomitant medications included SINGULAIR 10mg q.d. and NECON q.d. At the time of the report, the patient reported that still continued to have symptoms of a slight headache and slight congestion and was not recovered from the event. No additional information was provided. Documents held by sender: None.				Y					N	10/07/2008	10/07/2008	0	Not reported	UNK	UNK	SINGULAIR; NECON		The patient had no pre-existing medical conditions and no illness at the time of vaccination. The patient had known allergies to pollen and dust.		200803107	1						1	Chills; Ear discomfort; Headache; Pharyngeal oedema; Pharyngolaryngeal pain; Pyrexia; Upper respiratory tract congestion; Wheezing	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328920	10/17/2008	VA	20.0	20		F	10/06/2008	Sometime in 1968, she received 1/2 dose influenza vaccine due to mother reporting allergy to everything while in school. That night c/o fever, hot red face, site swelling and tenderness, pain with moving shoulder. Denied cp, sob, angioedema, wheezing, dysphagia, rashes, n/v/d, or any other discomfort. Treated with steroids and antibiotics and told allergic to influenza. No influenza vaccine since 1968.									U	01/01/1968	01/01/1968	0		UNK	UNK						1						1	Erythema; Injection site pain; Injection site swelling; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328921	10/17/2008	CO	66.0	66		F	10/15/2008	Severe arm pain, 9/10, pain in left arm. Limited range of motion in left arm at least 9 days, post vaccination.									N	10/07/2008	10/07/2008	0	None	PUB	PVT	IBu/	None	Osteoarthritis/Celiac disease			1						1	Injected limb mobility decreased; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89971~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0200U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328923	10/17/2008	PA	39.0	39		F	10/17/2008	Had immunization at 10 AM. At 2 PM, school nurse called reporting symptoms of wheezing, and feeling lump in throat. Advised to go to ER. ER report, said mild difficulty breathing and swallowing. Pt received SOLU-MEDROL and BENADRYL and PEPCID. Observed 3 hrs. Discharged on Prednisone and BENADRYL.				Y					Y	10/16/2008	10/16/2008	0		PVT	PVT		Fall environmental allergy	Erythromycin - GI intolerance			1						1	Dysphagia; Dyspnoea; Sensation of foreign body; Wheezing	FLU3~SANOFI PASTEUR~UF455BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~U2754AA~UNK~IM~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0328924	10/17/2008	MA	7.0	7		M	10/17/2008	Redness noted underneath flu site injection. 3cm x 5cm in size, slightly warm to touch - Rt arm.				Y					Y	10/14/2008	10/15/2008	1		PVT	PVT			Strawberries; mold			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U2833AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328925	10/17/2008	ND	3.0	3		F	10/16/2008	Hives - diffuse, beginning morning after vaccination.				Y					U	10/15/2008	10/16/2008	1		PVT	PVT		None	None			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2745AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328926	10/17/2008	LA	49.0	49		F	10/16/2008	Day after vaccine - just below injection site, developed a red welt, itching, 2 x 2 - welt, 2 circle (red) under the welt. Remain with.									U	10/14/2008	10/15/2008	1	None	PVT	PVT	Hormone; ZURTEC; SYNTHROID; Nasal steroid; Allergy Inj.		Environmental allergies; wheat; high BP; hypothyroidism			1						1	Erythema; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA209AA~7+~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0328927	10/17/2008	OH	5.0	5		F	10/16/2008	Approx 48 hrs after vaccine (6 inch x 8 inch), red, warm, indurated area, surrounding injection site - tender to touch.				Y					Y	10/14/2008	10/14/2008	0		PVT	OTH						1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site warmth	DTAP~SANOFI PASTEUR~C2999AA~5~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2810AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A1109~5~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1079X~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0791X~2~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0328930	10/17/2008	TN	59.0	59		F	10/11/2008	Patient had some slight bleeding at  injection site and then it swelled up to size of golf ball (looked to be blood filled). Applied ice to site and swelling decreased over next 30 minutes. Gave patient 2 IBUPROFEN (200 mg) to take at home.									Y	10/11/2008	10/11/2008	0		OTH	PVT						1						1	Injection site haemorrhage; Injection site swelling	FLU3~CSL LIMITED~02349111A~UNK~UN~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0328931	10/17/2008	WI	3.0	3		F	10/09/2008	Patient with low grade fever, new runny nose, nasal congestion consistent with SXS that of FLUMIST.				Y					U	10/06/2008	10/08/2008	2		PVT	PVT	DEJONIDE 0.5 SODIUM FLORIDE	Cold SXS				1						1	Nasal congestion; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500563P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0328937	10/17/2008	PA	6.0	6		M	10/10/2008	(L) arm and chest redness. Axillary adenopathy.				Y					U	10/07/2008	10/09/2008	2		PVT	PVT			RAD			1						1	Erythema; Lymphadenopathy	FLU3~SANOFI PASTEUR~U2790BA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328939	10/17/2008	NC	62.0	62		F	10/10/2008	Redness, swelling and pain at injection site L lower arm Received Rx for Abx and advised to use cool compress and OTC antihistamine.									U	10/07/2008	10/08/2008	1	We gave both injections in (L) arm due to (R) breast masectomy.	PVT	PVT		None	hx breast CA (R); GERD; diverticulosis; chronic cystitis			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2811AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0619X~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328940	10/17/2008	MA	76.0	76		F	10/12/2008	Redness - from shoulder to wrist - 4 days Swelling - shoulder to elbow - 3 days black and blue - shoulder to elbow - 3 days fever - 3 days									Y	10/02/2008	10/03/2008	1		PVT	OTH	Many					1						1	Contusion; Erythema; Oedema peripheral; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0328941	10/17/2008	AZ	1.1	1	.1	F	10/13/2008	After getting vaccines, plus chills, fever to 102.9 seen at ER, did blood, urine, CXR All normal Low grade fever since ER visit (10-10-08) ER (10-9-08) shots given (10-8-08)				Y					Y	10/08/2008	10/08/2008	0	urine, blood, CXR	PVT	PUB		fever				1						1	Blood culture negative; Chest X-ray normal; Chills; Culture urine negative; Pyrexia	FLU3~SANOFI PASTEUR~U2751AA~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UFH66AA~UNK~UN~LL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0483X~UNK~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C49922~UNK~UN~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0328942	10/17/2008	VA	6.0	6		F	10/13/2008	Area 6 1/2 x 7 1/2 cm erythema, warm and raised at injection site.									U	10/11/2008	10/11/2008	0	CAP RAST Eggs	PVT	OTH		None	Reaction to Pertussis Vaccination xt			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Laboratory test; Radioallergosorbent test	FLU3~SANOFI PASTEUR~U2772AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328943	10/17/2008	ID	53.0	53		F		Patient complained of dizziness, spaced out feeling, fuzzy mentally, chest hurting.				Y					Y	10/08/2008	10/08/2008	0	Monitoring blood pressure/pulse	OTH	PVT		None				1						1	Chest pain; Dizziness; Feeling abnormal; Heart rate	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0328944	10/17/2008	ID	2.0	2	.7	F	10/14/2008	None										10/14/2008				PVT	PVT						1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89969~1~IM~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0328945	10/17/2008	NE	25.0	25		F	10/14/2008	None stated.				Y					Y	10/14/2008	10/14/2008	0	Available on ED report 10/14/08	PUB	PVT						1						1	Unevaluable event; Blood pressure increased; Dizziness; Dyspnoea; Heart rate increased; Immediate post-injection reaction; Oropharyngeal pain; Pregnancy test; Throat tightness	FLU3~SANOFI PASTEUR~U2766AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2766AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0328946	10/17/2008	OH	51.0	51		F	10/13/2008	None stated.				Y					U	10/04/2008	10/05/2008	1	Needed BENADRYL and Prednisone	OTH	PVT			NKDA stated			1						1	Unevaluable event	FLU3~CSL LIMITED~02049111A~UNK~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0328960	10/17/2008	ME	32.0	32		M	10/10/2008	Erythema and significant edema to the Right Deltoid area extending to the Right elbow associated with pain - large local reaction.									Y	10/07/2008	10/09/2008	2		MIL	MIL	None	None	SAR			1						1	Erythema; Local reaction; Oedema peripheral; Pain in extremity	ANTH~EMERGENT BIOSOLUTIONS~FAV148~4~IM~RA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~AFLLA197AA~6~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328962	10/17/2008	IL	4.0	4		F	10/10/2008	Diarrhea yesterday after MIST - Today mom reported c/o H/A, runny nose and looks pale.										10/09/2008	10/09/2008	0		PVT	PVT		None				1						1	Diarrhoea; Headache; Pallor; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~5005589~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|UNK~UNKNOWN MANUFACTURER~~UNK~UN~UN~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA		Influenza
0328980	10/17/2008	GA				U	10/17/2008	Heptatitis A and Varicella were given on October 14th in patient's right arm. Varicella was in LA. On 10/15 mother called stating patients left arm was swollen and red but no fever. Cool compresses advised. 10/16 mother called Right arm swollen and hot and size of $.50 piece and feels like a needle is in arm. Patient seen in office 10/16 with possible cellulits and reaction to Varicella. Placed on Omnicef and warm compresses. To be rechecked on 10/18 in the office.									Y				none	PVT	PVT		none	none			1						1	Erythema; Immunisation reaction; Oedema peripheral; Pain; Skin warm	FLUN3~MEDIMMUNE VACCINES, INC.~500567P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB297AA~1~IM~RA~HEP A (HAVRIX)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52Bo2oAA~6~IM~LA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~0132X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0328981	10/17/2008	IL	15.0	15		F	10/17/2008	Within an hour after receiving immunizations the client returned to the clinic c/o itching on the feet and legs. Did have hives below the waist. Treatment was Benadryl 50mg IM in left deltoid. Which the client tolerated well and relief was noted.									Y	10/13/2008	10/13/2008	0		PUB	UNK	None	None	None			1						1	Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8788204~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~SANOFI PASTEUR~U2349BA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0328982	10/17/2008	OR	43.0	43		F	10/17/2008	I had my shot at 1:00 pm, I went back to work and felt a little disoriented and my arm ached.By 5:00 pm that same day, I got a  heavy,wheezing feeling in my chest and coughed and coughed, my body was aching,my eyes got very red and irratated, aprox 3:00 am i woke up and my eyes were swollen and almost matted shut.went to the Drs the following day at 10:30 am. And she said she does not beleive it was from the shot she belives I justhappened to get a virus on the same day. I do not believe this is the case. normally if I get sick my neck glands start hurting a couple days before I come down with something, and I was completly fine before the shot. The Dr. told me to take tylenol cold medicine,benadryl, and rest. Today I stayed home from work again, as for I am aching bad and very weak feeling, however my low grade fever has not come back yet today.				Y					N	10/15/2008	10/15/2008	0		PUB	PVT	estradiol	none				1						1	Activities of daily living impaired; Asthenia; Chest discomfort; Cough; Disorientation; Eye irritation; Eye swelling; Ocular hyperaemia; Pain; Pain in extremity; Pyrexia; Viral infection; Wheezing	FLU3~SANOFI PASTEUR~6714940~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328983	10/17/2008	LA	62.0	62		M	10/17/2008	Reports approx. 30 minutes after the flu shot was feeling bad and then when got home had difficulty breathing, syncope, vomited, dizziness.  Had the flu shot before with no previous reactions in the past.  Refused to go to hospital.									Y	10/16/2008	10/16/2008	0		UNK	PVT						1						1	Dizziness; Dyspnoea; Feeling abnormal; No reaction on previous exposure to drug; Syncope; Vomiting	FLU3~SANOFI PASTEUR~U2802AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328984	10/17/2008	UT	1.0	1	.0	M	10/17/2008	redness, swelling on left thigh				Y					Y	09/26/2008	10/10/2008	14	N/A	PVT	PVT	N/A	N/A	N/A			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~UT2782CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB259AA~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1119X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1000X~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0328985	10/17/2008	UT	2.0	2	.1	M	10/17/2008	redness, swelling on left thigh				Y					Y	09/30/2008	10/09/2008	9	N/A	PVT	PVT	N/A	N/A	N/A			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~UT2782CA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB259AA~1~IM~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1119X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1000X~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0328986	10/17/2008	IL	58.0	58		F	10/17/2008	Rec'd Afluria vaccine at 9am. Reports at 5pm began to feel flushed, aching, chilled. Reports during night had shaking chills and felt aching all over. Took Tylenol for complaints. At 9am reports still doesn't feel well. Skin flushed. Cheeks reddened. Temp 99.2 otic. Hands cool to touch. c/o feeling hot/cold. c/o dry mouth. Reports has had the flu vaccine before but never had a problem before. Reports felt fine prior to getting the vaccine and this is not my usual when I do get sick.										10/16/2008	10/16/2008	0		MIL	PVT	METFORMIN LISINOPRIL GLYBURIDE CRESTOR FISH OIL	NONE	DIABETES HYPERTENSION			1						1	Body temperature increased; Chills; Dry mouth; Erythema; Feeling of body temperature change; Flushing; Malaise; No reaction on previous exposure to drug; Pain; Tremor	FLU3~CSL LIMITED~01349111A~3~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0328987	10/17/2008	IN	53.0	53		F	10/17/2008	At approximately 5:30 PM patient started developing scratchy eyes and blurry vision. She felt like she could not take a deep breath. After a while she felt like her throat was closing up and she developed mucus in her eyes. She waited until her husband came home and he took her to the emergency room about 8:00 PM. She said her breathing was better by that time, but she had a horrible headache and was freezing. She was given a breathing treatment at the emergency room. She was discharged with an inhaler and Benadryl. The next morning she still had a horrible headache, bloodshot eyes, and was chilling. Patient still has scratchy eyes today, but all other symptoms have subsided.				Y					Y	10/15/2008	10/15/2008	0		PUB	PVT	Takes medication daily for Hypothyroidism - thinks it is Levothyroxine.	No	Patient experienced a severe allergic reaction after outpatient surgery in 2006. She was hospitalized - unable to determine what medication caused the reaction.			1						1	Chills; Dyspnoea; Eye discharge; Eye pruritus; Feeling cold; Headache; Ocular hyperaemia; Throat tightness; Vision blurred	FLU3~SANOFI PASTEUR~PMC-U2790BA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0328989	10/17/2008	NH	57.0	57		M	10/17/2008	10/15- body aches, diarhhea, fever (sweats, fever blister on lip) 10/16 symptoms continued and felt a little better. without diarrhea this morning(10/17/2008).  Still  aches and nausea.										10/14/2008	10/15/2008	1		PUB	UNK	none	none	none			1						1	Diarrhoea; Hyperhidrosis; Nausea; Oral herpes; Pain; Pyrexia	FLU3~SANOFI PASTEUR~u2751aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328990	10/17/2008	TN	20.0	20		F	10/17/2008	History of Guillain-Barre' syndrome.  Saw private provider 10/16/2008 with complaints of fever, chills, nasal drainage, lower back numbness. Given injection of depo-medrol, dexamethasone, and rocephin.  RX for claritin.									U	10/13/2008	10/16/2008	3		PUB	PUB	Paxil	No	History of Guillain-Barre			1						1	Chills; Hypoaesthesia; Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~U2768AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0072X~1~IM~LA~HPV (GARDASIL)~1|TDAP~SANOFI PASTEUR~C2768BA~1~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0328991	10/17/2008	ID	78.0	78		F	10/17/2008	Dizziness, Lightheaded, Faint, Sweaty.				Y					Y	10/15/2008	10/15/2008	0		UNK	UNK			Pt had enlarged heart so paramedics took her to hospital. Final result think it was due to medications and not vaccine			1						1	Dizziness; Hyperhidrosis; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0038U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0328992	10/17/2008	NH	58.0	58		F	10/17/2008	10/16/2008 3 PM R eye feeling puffy.  Discomfort in eyes with redness and swellling of upper lids.  Took OTC allergy med ? claritin.  Hydrocortisone cream on both lids.  Swelling has decreased this am 10/17.  Cont. with OTC allergy med and CVS medication for chest congestion  Zythromycin for 5 days										10/14/2008	10/16/2008	2		PUB	UNK	OTC allergy medications, Multivitamin	zythromax on sept 30th x 5 days for laryngytis				1						1	Eye pain; Eye swelling; Eyelid oedema; Ocular hyperaemia; Upper respiratory tract congestion	FLU3~SANOFI PASTEUR~u2751aa~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328994	10/17/2008	MI	78.0	78		F	10/17/2008	A few minutes after receiving the injection I felt strange, a little weak, and then noticed a rapid, strong heartbeat. (I had started to go to the gym but changed my mind because I didn't feel quite right.)I walked back to the office, got some tea, and took a Tylenol regular strength tablet. The heartbeat subsided and I felt OK within 30-45 minutes.									Y	10/15/2008	10/15/2008	0		UNK	UNK	Zantac; raloxefene; vitamins; calcium; Omega-3	No	None			1						1	Asthenia; Feeling abnormal; Heart rate increased; Palpitations	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328995	10/17/2008	NH	42.0	42		F	10/17/2008	10/16 am woke up with stom pain.(sharp).  Felt tired, body achee that increased throughout the day.  By 5Pm could not stand up, slept for 3 hours in the afternoon.  Felt hot and cold.  Woke up at 5AM today 10/17/2008 heavy perspiration, aches are gone, some nausea									Y	10/14/2008	10/16/2008	2	none	PUB	UNK	Lexapro	none	Anxiety			1						1	Abdominal pain upper; Dysstasia; Fatigue; Feeling of body temperature change; Hyperhidrosis; Nausea; Pain	FLU3~SANOFI PASTEUR~u2751aa~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328996	10/17/2008	MD	18.0	18		F	10/16/2008	Patient was seen at ER yesterday evening for evaluation of facial rash that developed approximately 8 hours after receiving flu mist vaccine.  She denies fever, chills, lip or throat swelling, or pruritis and the rash is confined to her face primarily the cheeks.  Patient has not previously received any flu vaccine.  She was given Benadryl at hospital and told to follow up in clinic.  No signs or symptoms of anaphylaxis.				Y					Y	10/09/2008	10/09/2008	0		MIL	MIL	None	None	None			1						1	Rash	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0328997	10/17/2008	FL	52.0			F	10/17/2008	Within minutes of receiving the vaccine in the left deltoid, employee experienced numbness on the left side of face and weakness/numbness of the left arm and headache.  Weakness/numbness begain wearing off about 2 pm same date but had the headache throughout the night.  Rx'd with Motrin.  Symptoms resolved.									Y				N/A	UNK	PVT		None known.	Levaquin			1						1	Headache; Hypoaesthesia; Hypoaesthesia facial; Muscular weakness; Headache; Hemiparesis; Hypoaesthesia; Hypoaesthesia facial	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8788202~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~878802~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0328997	10/17/2008	FL	52.0	52		F	10/17/2008	Within minutes of receiving the vaccine ion the left deltoid, employee experienced numbness on the left side of face and weakness/numbness of the left arm and headache. Weakness/numbness began wearing off about 2 PM same date but had the headache throughout the night. Prescribed with MOTRIN Symptoms resolved.									Y	10/14/2008	10/14/2008	0		OTH	PVT		None known	Levaquin			1						2	Headache; Hypoaesthesia; Hypoaesthesia facial; Muscular weakness; Headache; Hemiparesis; Hypoaesthesia; Hypoaesthesia facial	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8788202~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~878802~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0328998	10/17/2008	MA	77.0	77		F	10/17/2008	Pt developed red, swollen painful deltoid.  Developed temp of 101.8 overnight following vaccine administration.  UA neg, blood cultures sent.  Pt receiving releif from tylenol, ice.  Currently afebrile.  12/23/08 Reviewed hospital medical records of 10/14-10/18/2008. FINAL DX: atrial fibrillation; allergic reaction to influenza vaccine(injection site swelling & redness, fever 102). Records reveal patient experienced palpitations, rapid irregular heartbeat, chest heaviness, feeling unwell, SOB, diaphoretic.  In ER, rapid atrial fib treated w/meds & cardioversion.  received pneumovax right arm & influenza vax left arm.  Same day developed swelling & redness over the left arm w/fever 102.  Fever & swelling resolved by next day.  D/C to home.							Y		U	10/16/2008	10/17/2008	1	Tmax 101.8 (PO)  LABS: CBC WNL.  Blood & urine c/s neg.  CXR WNL.  EKG abnormal.  Cardiac enzymes neg.	UNK	UNK	gemfibrozil, lisinpril, digoxin, alprazolam, celexa, atenolol, warfarin sodium	Admitted with rapid AF- in NSR at time of vaccination.	rheumatic heart disease, ascending TAA, HTN, HLD  PMH: mechanical AVR/MVR on long term anticoagulation, HOH			1						1	Urine analysis normal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA380AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0983X~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0328999	10/17/2008	IN	36.0	36		F	10/17/2008	Patient's lower lip began swelling about 8:00 PM on Wednesday, 10/15/08. She came to our facility on Thursday morning. We advised her to call her physician, due to large swelling on lower lip. Patient saw M.D. on Thursday, 10/16/08 and was given a benadryl type medication. Swelling was completely gone by Friday morning.				Y					Y	10/15/2008	10/15/2008	0		PUB	PVT	Patient sees an Allergist for environmental allergies. She takes Allegra D, Singulair, and Rhinocort Aqua Nasal Spray. She also takes Provigil 200mgm BID for Narcolepsy.	No	Environmental allergies - dust, mold, cockroaches. Patient also has Anemia and Narcolepsy.			1						1	Lip swelling	FLU3~SANOFI PASTEUR~PMC-U2790BA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329000	10/17/2008	GA	66.0	66		F	10/17/2008	administered Sat. Oct. 11, 2008.  Called CVS Sunday, call not returned.  Fever Sat. night, 3x4 inch swelling, hot to touch.  Called CVS referal number also.  Said swelling was normal.  Called minute clinic again Monday, Oct 12, (holiday). Said maybe I should see my Dr.  Swelling was less red.  I did cold packs as suggested.  Took Tylenol.  Did not see Dr.  (holiday).  Improved daily.									U	10/11/2008	10/11/2008	0		UNK	PVT						1						1	Erythema; Pyrexia; Skin warm; Swelling	FLUX~UNKNOWN MANUFACTURER~V04.81~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~V03.82~UNK~UN~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0329001	10/17/2008	CA	24.0	24		M	10/17/2008	Patient received FluMist Nasal Influenza vaccine  on 10/9/08 around 10:30am.  10/10/08 left hand began itching and mild swelling. 10/11/08 left hand and palm red, swollen, itching, right hand started itching.10/12/08 Both hands itching and swollen, hive type lesions appeared at ankles and feet, hives on side of head and torso of body appeared on this date. 10/13/08 Symptoms still present patient went to physician at Hospital who diagnosed as an allergic reaction and prescribed an over the counter anti-itch cream, Clodetasol and Hydroxyz-Hcl 25mg.  Patient still on medications which he states are controlling the itch which when scratched begins to burn.  Patient has not returned to work at this time due to the hives which are evident on his body.				Y					N	10/09/2008	10/10/2008	1	None done	UNK	UNK	none	none	none			1						1	Activities of daily living impaired; Erythema; Hypersensitivity; Oedema peripheral; Pruritus; Skin burning sensation; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500562P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0329002	10/17/2008	MD	46.0	46		F	10/17/2008	Pt recieve flu vaccine and developed itchy red eyes within 24 hrs of vaccine, same problem occured the year before.  Pt this year treated for allergic conjuctivitis with patonol prn;  if									U	10/16/2008	10/16/2008	0	none	MIL	PUB		none	unknown			1						1	Conjunctivitis allergic; Eye pruritus; Ocular hyperaemia; Vaccine positive rechallenge	FLU3~CSL LIMITED~01449111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0329004	10/17/2008	CT	62.0	62		F	10/17/2008	Shot given right triceps and reported within 24 hrs a very significant 3 x 8 inch redness, tenderness and swelling starting at the injection site and spreading downward almost to the elbow. There was no sign of infection and the patient denied any other symptoms. I saw the site on 10/17/08 and it appeared to me to be a much larger than expected reaction compared to those I have seen in 25 years of giving and receiving flu shots. I agreed that there was no sign of infection. The patient has taken flu shots for many years and never reported any similar reactions. We are wondering whether she should now consider herself allergic to all flu vaccines and whether she should get flu vaccines ever again.									U	10/15/2008	10/15/2008	0	none needed although patient did have a culture proven UTI diagnosed on the same day. She was started on Cipro 500 mg the same night but the reaction started before the Cipro was administered and there were no other areas of swelling on the body.	PVT	PVT	Coumadin, Lipitor 80 mg, Atenolol 50 mg, Xanax 0.5 md prn, Cipro 500 mg just started after shot given	Had a week's worth of nausea and pressure of bladder and rectum.  U/a pos. for leuks, nitrites, and blood.  U.C pos. for greater than 100K gm neg. bacilli so far.	S/P CVA, hypertension, increased cholesterol, smoker, atrial fibrillation, anxiety disorder,			1						1	Culture urine positive; Injection site erythema; Injection site pain; Injection site swelling; No reaction on previous exposure to drug	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA179AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0329005	10/17/2008	CA	70.0	71		M	10/17/2008	4 hours after receiving the flu vaccination complained of bad chills, body aches, head ache, fatigue and upset stomach. (Did not take temperature.) The next day continued to have chills, upset stomach and fatigue but they were not as severe.  Continued to feel tired and have an upset stomach the second day following the injection, but chills were gone.									U	10/15/2008	10/15/2008	0	none	PUB	PUB	Heart Meds and blood pressure meds, do not know the names	denies any	Hypertension, history of heart bypass 5 years ago.			1						1	Chills; Fatigue; Headache; Pain; Stomach discomfort	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0329007	10/17/2008	IN	49.0	49		M	10/17/2008	Cold sweats, dizziness lasting one week since influenza vaccine. Head feels heavy.				Y					U	10/10/2008	10/12/2008	2	Went to ER on Sunday 10/12 Lab tests, CT scan.	PVT	UNK	None	None	lactose intolerant			1						1	Cold sweat; Computerised tomogram; Dizziness; Head discomfort; Laboratory test	FLUX~UNKNOWN MANUFACTURER~~7+~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0329009	10/17/2008	NY		41		F	10/17/2008	Pt broke out in hives, had difficulty breathing, after receiving the flulaval vaccine on 10/11/08				Y					Y	10/11/2008	10/11/2008	0		UNK	PVT		None	None			1						1	Dyspnoea; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFA175AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0329010	10/17/2008	IL	0.5	0	.5	M	10/17/2008	3 days after receiving vaccines intussusception was suspected and patient was Hospital were intussusception was diagnosed and was unable to be reduced by enema and had to be done manually in the OR.  No bowel resectioning was necessary.  10/28/08 Reviewed hospital medical records of 10/9-10/13/2008. FINAL DX: Intussusception, surgically reduced Records reveal patient experienced intermittent crampy abdominal pain, abdominal distention & vomiting x 3 days.  Taken emergently to OR when enema administration did not reduce IS.  Open reduction performed.  Progressed well & d/c to home.					Y	4			Y	10/06/2008	10/09/2008	3	LABS: WBC 22.7(H), plts 507(H), neutros 73%(H), lymphs 18%(L).  US of abdomen (+) IS.  Air contrast enema unsuccessful at reducing IS.	UNK	UNK						1						1	Enema administration; Intussusception; Surgery; Abdominal mass; Barium enema abnormal; Intussusception; Pyrexia; Surgery; Vomiting	DTAPIPVHIB~SANOFI PASTEUR~C3174AA~1~IM~LL~DTAP + IPV + HIB (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U2809AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C81640~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0898X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1|DTAPIPVHIB~SANOFI PASTEUR~C3174AA~UNK~UN~UN~DTAP + IPV + HIB (PENTACEL)~2|FLU3~SANOFI PASTEUR~U2809AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|PNC~PFIZER\WYETH~C86140~UNK~UN~UN~PNEUMO (PREVNAR)~2|RV5~MERCK & CO. INC.~0898X~3~PO~MO~ROTAVIRUS (ROTATEQ)~2	USA	Hospitalisation	Influenza
0329011	10/17/2008	VA	44.0			F	10/17/2008	It started with me feeling very tired and dizzy.  So I went home and went to bed.  Then I was shaking and chilled with my teeth chattering uncontrolably, even though I was completely (including my head) under two heavy blankets.  Next I vomited so hard that I was also incontinent at the same time.  The fever was making my head ache.  The chills and shaking continued for the next six hours with me having to go to the bathroom every half hour.  Because I was obviously losing a lot of fluid I tried to drink something but my throat was so swollen and sore that I could only trickle the fluid in.  My muscles were aching.  I am not allergic to eggs, latex, Thimerosal and I have never had Guillian Barre Syndrome.  In fact, I have taken a flu shot every year for more than a decade because I work at a center and come in contact with 3000-10,000 people on any given night.  I am not very young or very old and I am otherwise very healthy.									Y	10/15/2008	10/15/2008	0		UNK	UNK		none	none			1						1	Chills; Dizziness; Fatigue; Headache; Incontinence; Myalgia; No reaction on previous exposure to drug; Oropharyngeal pain; Pharyngeal oedema; Pyrexia; Tremor; Vomiting	FLUX~UNKNOWN MANUFACTURER~vo4.81, 90658~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329012	10/17/2008	ME	43.0	43		F	10/17/2008	I was givin the infuenza vaccine on Tuesday evening and went directly home and by 10pm that evening my eyes were burning and otherwise felt fine...figured I was tired and decided to go to bed.  I woke up at 2pm with my eyes stuck together and goopy crud in the corners of my eyes, I rinsed them with warm water and used tissues to clean them out.  I immediately thought of conjunctivitis and knew how contagious that was and wondered to myself if it could be a reaction to the flu shot.  I went downstairs to check if that was one of the symptoms and since it wasn't I decided to go back to bed and evaluate myself in the morning.  I got up and checked myself and my eyes seemed fine except for a little redness.  I run a daycare and that is my biggest concern so when parents arrived, I asked each one of them if they have or know of any conjuntivitis recently with any family member.  I got all negative responses so I felt I needed to call the doctor, I made an appt and rec'd antibiotic drops and started them that evening (WED 10/8).  Staff was the one that prescribed the drops and she really didn't know if it was conjunctivitis but said it would be just our luck that I woke up full blown with it.  My eyes were still a little red and itchy at that point but I wasn't getting the discharge from them.  The next 3 days I seemed fine other than being somewhat overtired but I had gone to bed late so didn't think too much about it.  By Saturday night 10/11/2008, at around 10 pm I felt heaviness in my chest and tried to get comfortable by taking off my bra, that didn't seem to help, then my ears started feeling like they were itchy inside, almost like water in them or something, I decided to go upstairs and wash up for bed around 10:30 or 11pm and noticed swelling in my upper jaw area on left side of face and the right was a little less swollen but defintely there.  I knew I needed to find benedryl so started looking for it, I then asked my daughter who was up what she thought and she told me to call the doctor right away.  I woke my husband and went downstairs to call the doctor and got the answering service and couldn't finish talking to them as I felt I couldn't breathe, it became more and more difficult to talk.  I took one benedryl pill and went directly to the emergency room with my husband and daughter.  From there on it became a nightmare.  I was told from the attending physician that it appeared to be a peanut allergy which I have never had before and to go home and take more benedryl and continue over the next 3 days to take it.  He didn't give me any more there and then evaluate, he just told me to take more and that one pill wasn't enough.  I asked if it could be related to the flu shot or the mumps and the answer was NO to both of my questions.  Not even a maybe.  I was told that too many days had gone by to be vaccine related and that it couldn't possibly be mumps because of my age and being vaccinated against it.  I went home and took more benedryl, one more pill and was out of it...and went right to bed.  I woke up the next morning with so much pressure in my head with a horrific headache and my face and neck triple in size.  I immediately took 2 more benedryl and went directly back to the hospital emergency room.  I wasn't given the proper attention there, at one point the chart was left on my bed and the P.A. had to take a call, 45 minutes later, my husband got a nurses attention in the E.R. and she took my chart and had to find the doctor which took another 1/2 hour.  Anyway, she wanted to know what brought me to the emergency room today??????  My face and neck (I had no neck, it was just one long face) totally disfigured.  I was crying and she still needed me to explain that I was swollen and had difficulty in breathing, I told her that I didn't think it was a peanut allergy, I thought it might have something to do with the flu shot or mumps, she said it couldn't be the flu shot because I would have had a reaction sooner, I told her about my eyes and she still said no and said since I think it might be the mumps she would do a mumps titer and treat me for the mumps because that is what she believed it could be.  I immediately explained that I ran a daycare and had my parents of 75 years of age, one being on oxygen living with us, and what kind of danger are all those people in and what I might have caused them.  She told me to wait and see the results, she said she called the lab and we will know results in 24 hours and to stop taking benedryl and take 600 mg of ibuprophen every 6 hours and acetamenaphen every 4 hours as needed for pain and to go back home and warn daycare of the possibility and follow up with my primary care physician, I had difficulty even staying awake at that point because of the benedryl and also I was soooooo uncomfortable to even speak or breathe and my oldest daughter met us my husband and I and my younger daughter at the emergency room and came back to my home to call all the daycare parents and the P.A. only gave me 6 masks to wear to make me feel better being around my elderly parents that live with me.  I had no other instructions.  The next day, Monday, October 13th I was even worse but figured I would get worse before I got better with the mumps and it had to run its course, we were told to call for results, I called twice and they didnt have results yet, they kept telling me to call back, my husband called and they said I don't know who told you 24 hours but it is 48 hours.....ugh. We had to call all the parents again and tell them we didn't know yet.  My husband called the doctors and made a Wednesday appt to be seen by my primary care Dr.  Tuesday morning came and I woke up at about 5:30am gagging and coughing and was due to take ibuprophen so my husband gave me 3 pills and water....I got the pills lodged in my throat and could barely drink water!  I was definitely worse and thought I was dying and knew I needed to do something before I did. I came downstairs and asked my husband not to go into work because I was scared and wanted to go to the doctors sooner than later so I rested on the couch and ended up falling into a deep sleep for the first time since Sat. A few hours went by and my husband was shaking me telling me to sit up because I was choking.  I was all shaky and when I realized where I was and the condition I was in, it really felt like a nightmare.  I was crying and sooooo upset and decided to call the CDC for answers.  They told me it most definitely could be a reaction to the flu shot....that was the first time anyone ever told me that.  The contacted an epidemiologist and asked if he could contact me directly and I said yes.  About a half hour went by and someone from the CDC called and told me he thought it was a reaction to the flu shot and not the mumps but because I had a mumps titer I still needed to be quaranteed and take necessary precautions before I did anything or went anywhere.  The hospital never should have let me go!!  The first time I went in there they should have given me something and then evaluated me.  I got nothing!!  I was basically sent home to suffocate to death.  My husband tried several times to get through to the doctors office by phone and kept getting disconnected so he drove down and requested a rush that the doctor call me immediately because I was getting worse and worse and said we were in contact with the CDC so the doctor called me back and said he would call in some prednisone.  I declined any meds as I told him I didn't trust the pharmacutical companies and I was basically all upset and he tried to calm me down and told me he would write out the prescription and leave it there and if I changed my mind I could call back and get it.  I was getting worse by afternoon and by this time had a tennis ball size swelling above my chest right before my cleavage started.  A friend of mine that is a daycare parent that worked for a pharmacist for 2 years talked me into trying the prednisone and told me I could basically suffocate so I decided to get the prescription.  I took 4 prednisone that night and noticed a little less swelling around my jaw.  First time since Saturday..a slight improvement of swelling going down.  My daughter researched and found a website about oculo-respiratory syndrome associated with influenza vaccine and told me about it and I brought that information to my doctor the next morning and he said that most definitely that could be related to my problem and was glad I decided to take the prednisone because he said it was taking over my body as it was now into my chest area.  My husband called the lab that same evening and got the results that proved I did not have the mumps therefore was not considered contagious but was by no means ready to run my daycare.  I stopped taking ibuprophen because the pharmacist told me not to take it with prednisone and I was weak all over, heavy feeling which I am presently still feeling.  My armpits ache and so do my wrists and my arms feel as heavy as my chest.  I started typing this at 10am and it is now 3:21.pm  I get tired from even typing...anyway, I feel that people need to be aware, emergency rooms ecspecially if someone has had the flu vaccine and they send them home to die.  This by far was the most terrifying illness I have yet to have and feel still a level of anxiety that I am not comfortable with.  I have questions that remain unanswered.  The doctor tells me we will have to wait and see how I do after taking 12 days of prednisone and take it from there.  I am trying to handle one day at a time.  I have been self employed for 16 years and have run a successful business and feel uncertain of my abilities now. I feel I shouldn't have been the one to diagnos myself, luckily my family was here with me and my husband woke me back up that morning when I was choking....what might have happened?  I am unsure.  I have already lost a whole weeks worth of pay and intend on opening as soon as possible, unfortunately, I can't give my daycare parents any answers to my recovery time, so what do I do and what do they do?  I don't know if this is permanent or not?  11/5/2008 PCP records received including 2 ER records. Pt in 10/7/08 for leg swelling and discoloration (DX: dependant edema- legs, bilateral). Flu shot given. Returned 10/8/08 with eye burning and discharge. DX: Conjunctivitis. ER visit 10/12/08 for c/o worsening facial and jaw swelling, as well as feeling unwell and weak. PE (+) for bilateral parotid gland swelling and tenderness. Dx: Parotiditis. ER visit 10/14/08 for allergic reaction. F/U with PCP 10/15/08 with DX:  urticaria, probably due to Flu vaccine.			Y	Y					Y	10/07/2008	10/08/2008	1	Mumps Ab 1.81 units IV test performed at ARUP Laboratories which proved I had antibodies detected therefore clinical symptoms indicated immunity.  I also had a WBC & Differential done along with Erythrocytes and Platelets . I have a copy of the report which I would gladly fax to you if needed.	UNK	UNK		I went in for a concern of tenderness to my shins that I have had for years but noticed a little discoloration in small area of shin and provider told me it was just spider veins and gave me a script to be fitted for elastic stockings.	allergic to penecillin and amoxicillin. PMH:  PCN allergy			1						1	Anxiety; Arthralgia; Asthenia; Chest discomfort; Choking; Cough; Crying; Differential white blood cell count; Dyspnoea; Ear discomfort; Eye discharge; Eye irritation; Eye pruritus; Fatigue; Headache; Local swelling; Mumps antibody test positive; Ocular hyperaemia; Platelet count; Pruritus; Red blood cell count; Retching; Sensation of heaviness; Swelling face; Tremor; White blood cell count; Dyspnoea; Erythema; Face oedema; Fatigue	FLU3~SANOFI PASTEUR~U2790AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2790AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening	Influenza
0329014	10/17/2008	OH	25.0	25		M	10/17/2008	~15-30 minutes after receiving fluzone in left deltoid mtoher stated that pt. tongue began to swell.  Two hours after symptoms began his mother called the health department and stated that his tongue was swelling and wanted to know what to do.  Health department staff informed mother to immediately call 911, but had caregiver take him to local ER. According to mother, he received benadryl and steriods and sent home from ER.  He was home resting, without any difficulty, within 3 hours of treatment.				Y					Y	10/17/2008	10/17/2008	0		PUB	PUB		None stated or observed at time of administration				1						1	Swollen tongue	FLU3~SANOFI PASTEUR~U2832AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329016	10/17/2008	MS	46.0	46		M	10/17/2008	Within 4 hours of administration of Fluzone vaccine, pt had temperature of 103 degrees and body aches, weak and sore throat.  All symptoms persisted for more than 24 hours.									Y	10/16/2008	10/16/2008	0		UNK	UNK	CRESTOR AND INDOCIN			SAME EVENT~Influenza (Seasonal) (no brand name)~1~44.00~In Patient		1						1	Asthenia; Body temperature increased; Oropharyngeal pain; Pain	FLU3~SANOFI PASTEUR~V2759A~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329018	10/17/2008	MO	24.0	24		F	10/17/2008	Flushing, itching, chest tightness, and dyspnea immediately after flu vaccine administration.  Received single adult epinephrine autoinjector.  Oxygen 15-10 LPM via nonrebreather mask.  Patient was transported to Medical Center via ambulance. 10/21/08 Reviewed hospital medical records of 10/9-10/2008. FINAL DX: acute allergic reaction to flu shot Records reveal patient experienced hives, itching, SOB, wheezing, throat tightness & chest pain.  Tx w/epi, nebs, Benadryl & steroids.  29 weeks pregnant.  No reaction on prior flu shots.  Admitted for fetal monitoring overnight. D/C to home on continued antihistamines.					Y	1			Y	10/09/2008	10/09/2008	0	Unknown	UNK	UNK	Zoloft	None Pregnancy	Pregnancy, depression, migraines  Allergies: lortab & demerol (nausea, hives).			1						1	Chest discomfort; Dyspnoea; Flushing; Immediate post-injection reaction; Oxygen supplementation; Pruritus	FLU3~CSL LIMITED~01449111A~2~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Hospitalisation	Influenza
0329019	10/17/2008	AZ	84.0	84		F	10/17/2008	Developed dizziness, weakness and increase in heart rate on the day of the vaccination. Symptoms resolved after 2 days									Y	10/13/2008	10/13/2008	0		PUB	PVT						1						1	Asthenia; Dizziness; Heart rate increased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0329020	10/17/2008	MA	11.0	11		F	10/17/2008	Symptoms noticed on 10/15/2008.  Itchy, swollen, red, warm to touch area extending 4.5 * 5.5 inches left upper arm									Y	10/14/2008	10/15/2008	1		PVT	PUB						1						1	Erythema; Oedema peripheral; Pruritus; Skin warm	FLU3~SANOFI PASTEUR~U2766AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1152X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0329022	10/17/2008	WA	53.0	48		F	10/17/2008	Came to employee health 6 hours after vaccination and stated that she was experiencing throat tightness and felt that her face was swollen.  States has been sneezing every few minutes since vaccination and that face is burning. States she is short of breath. Appears to be very anxious.  B/P is 150/70 with Pulse of 76. Evaluated and given Claritin.  At 1315 B/P is 135/80 with pulse of 80.  Pulse oximetry is 98% saturation.  At 1330 B/P is 120/78, pulse is 74, RR is 26.  O2 Sat is 97%.  Discharged and will F/U.  Will take Claritin Qd through weekend.									Y	10/17/2008	10/17/2008	0	See #7	PVT	PVT	None	None	Allergy to DayQuil and to Berries			1						1	Anxiety; Blood pressure increased; Burning sensation; Dyspnoea; Heart rate normal; Oxygen saturation normal; Sneezing; Swelling face; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA357BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0329027	10/17/2008	MI	65.0	65		F	10/17/2008	I received Pneumovax which was administered by the local pharmacy at approximately 3 pm.  The injection was intensely painful.  The pain continued to get worse which kept me awake the entire night with no sleep due to the intense pain in my arm left arm.  My arm was hot to the touch.  I had a headache and was weak and tired.  My arm was severly swollen. My husband took me to our physician first thing the next morning.  The physician took one look at all the swelling and hot tissue and said that I had a raging infection.  He gave me some antibiotics and said if I was not better to call him after the weekend.  Our total cost for the doctor was $125 and $25 for the antibiotic and was not covered by insurance.  It is now 48 hours later and there is no improvement.  11/20/2008 Office records received from PCP for OV 10/16/08 with DX:  Cellulitis.  Insomnia. Pt presented with c/o rash, itching, ? chills, and sleep troubles. L shoulder warm and swollen and injection site. Tx with abx and Ambien			Y	Y					U	10/15/2008	10/15/2008	0	Physician stated that a severe infection was present at the site of the injection causing the arm and under the arm to swell significantly.	UNK	UNK		None				1						1	Asthenia; Fatigue; Headache; Infection; Injection site pain; Oedema peripheral; Pain in extremity; Skin warm; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~6~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening	Influenza
0329028	10/17/2008	CO	77.0	77		M	10/17/2008	10/2: Vet phones in to report what he suspects to be an adverse reaction to his flu  vaccine received on 22 Sep 08; he describes the immediate surrounding area to be  slightly reddened, tender and raised also experiencing mild soreness in left  deltoid.  Denies resp. problems, denies n/v/d or headache, afebrility noted; PCP  made aware, MD to eval.									Y	09/22/2008	10/01/2008	9	n/a	MIL	PUB	HCTZ, ALFUZOSIN	N/A	HTN, BPH, HYPERLIPIDEMIA			1						1	Injection site erythema; Injection site pain; Injection site swelling; Myalgia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~AFLLA181AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0329030	10/17/2008	AZ	7.0	7		M	10/17/2008	Patient had elevated fever up to 104 following vaccine									Y	10/14/2008	10/16/2008	2	Rapid Strep Test negative	UNK	UNK	none	none known	cashew, almonds, soybeans			1						1	Pyrexia; Streptococcal identification test; Streptococcal identification test negative	FLU3~SANOFI PASTEUR~U2802AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0971X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0329059	10/17/2008	MD	0.6	0	.6	M	10/17/2008	Benign Myoclonic Jerks.				Y					N	09/12/2008	09/17/2008	5	EEG x 2, CMP, Lactic acid	PVT	PVT		Runny nose, slight congestion	Melkels, Omphalomesenteric duct	None~ ()~~0.00~In Patient		1						1	Blood lactic acid; Electroencephalogram; Metabolic function test; Myoclonus	DTAP~SANOFI PASTEUR~C2951BA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2763AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF492AB~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C68310~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0894X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0329060	10/17/2008	MA	33.0	33		F	10/16/2008	Upset stomach, difficulty breathing through nose, puffy, itchy eyes, hives, swollen eyes and ears - Benadryl and Zyrtec.				Y					Y	10/15/2008	10/15/2008	0		OTH	OTH	None	None	None			1						1	Auricular swelling; Dyspnoea; Eye pruritus; Eye swelling; Stomach discomfort; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA207AA~1~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0329061	10/17/2008	WV	48.0	48		F	10/17/2008	Headache - slight - only for few hours vomited 2 times same evening									Y	10/15/2008	10/15/2008	0		PUB	UNK		No	No			1						1	Headache; Vomiting	FLU3~SANOFI PASTEUR~U2771aa~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329064	10/17/2008	WA	73.0	73		F	10/17/2008	Right arm swelling 2 days, after getting shots. (Notified us on 10/17/08). Developed rash, fever. she talked to doctor, not too concerned. Advised her to take TYLENOL and apply ice pack.									Y	10/09/2008	10/11/2008	2		OTH	UNK		None	None			1						1	Oedema peripheral; Pyrexia; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0803U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329065	10/17/2008	PA	12.0	12		M	10/17/2008	Large local reaction - redness, swelling. Took BENADRYL - agitation, rage, headache, pupils unequal, low LOC.				Y					Y	10/14/2008	10/16/2008	2	CBD; labs ok; CT head, negative	PVT	OTH		None				1						1	Agitation; Anger; Computerised tomogram normal; Erythema; Full blood count; Headache; Laboratory test; Local reaction; Loss of consciousness; Pupils unequal; Swelling	FLU3~SANOFI PASTEUR~V2757AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329066	10/17/2008	MT	27.0	27		F	10/15/2008	Tdap and TIV given. Approx. 10 min. after had hives, red eyes, itching, cough, scratchy throat. Vital signs stable throughout. Epinephrine 1:1000 0.2 ml SQ @ 1121; BENADRYL 25 mg IV @ 1125; BENADRYL 50 mg po @ 1150. Discharged home at 1220 in stable condition.				Y					Y	10/15/2008	10/15/2008	0		PUB	PVT	Metoprolol	None	None			1						1	Cough; Ocular hyperaemia; Pruritus; Throat irritation; Urticaria	FLU3~SANOFI PASTEUR~U2756AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2689AA~1~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0329067	10/17/2008	MT	52.0	52		M	10/15/2008	Received TIV approx 12:30. Reports pain down arm after injection. Approx 1 1/2 - 2 hrs. Post vaccination c/o chest and throat discomfort. States feels jittery. C/o Tinnitis. 25 mg BENEDRYL IM given. Physician diagnosed: Anxiety and (L) arm pain post injection D/C home stable.				Y					Y	10/15/2008	10/15/2008	0	EKG	PUB	PVT	KLONOPIN, PRN	None	No Known			1						1	Anxiety; Chest discomfort; Electrocardiogram; Feeling jittery; Oropharyngeal pain; Pain in extremity; Tinnitus	FLU3~SANOFI PASTEUR~U2756AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329068	10/17/2008	SC	39.0	39		F		Use of expired influenza vaccine. No c/o illness, symptoms.									Y	10/16/2008	10/16/2008	0	None	PVT	PVT		None	Allergy Sulfa / Hx of MS			1						1	Expired drug administered; No adverse event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA032AA~2~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0329069	10/17/2008	SC	42.0	42		F	10/17/2008	Use of expired influenza vaccine. No c/o illness, symptoms.									Y	10/17/2008	10/17/2008	0	None	PVT	PVT	None	None	None			1						1	Expired drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA032AA~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0329070	10/17/2008	NC	34.0	34		F	10/17/2008	Use of expired influenza vaccine. No c/o illness, symptoms.									Y	10/16/2008	10/16/2008	0	None	PVT	PVT		None	Pregnancy about 5 months gestation, EDC 2/09			1						1	Expired drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA032AA~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0329071	10/17/2008	MN	1.0	1	.0	F	10/17/2008	Small blisters around injection sight.									Y	10/03/2008	10/16/2008	13	None	PVT	OTH	None	None	None			1						1	Injection site vesicles	FLU3~SANOFI PASTEUR~UT2782FA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0865U~1~IM~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0999X~1~IM~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0329072	10/17/2008	MN	14.0	14		M	10/17/2008	Fever to 104, Headache frontal/maxillary				Y						10/16/2008	10/17/2008	1		PVT	UNK		None	None			1						1	Headache; Pyrexia	FLU3~SANOFI PASTEUR~U2670AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2670AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0329073	10/17/2008	AL	2.0	2	.2	M	10/17/2008	Child was seen in our office 10-16-08 and received the flu vaccine that evening. Mom states that she left our office and went to Wal-Mart. As she pulled into driveway @ home, less than 2 hrs later, child was staring and lips were blue, his O2 sat was 95. Ambulance was called and child taken to ER, dx - post-ictal. With febrile illness/child had low grade fever 101.4 degrees. No wheezing.				Y					Y	10/16/2008	10/16/2008	0		PVT	PUB	TYLENOL; PULMICORT Neb Tx; Albuterol Neb  Tx	Pharyngitis, prob. viral	BRAO			1						1	Cyanosis; Postictal state; Pyrexia; Staring	FLU3~SANOFI PASTEUR~U2829AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329074	10/17/2008	CA	68.0	68		M	10/17/2008	Pt developed cellulitis at the site of injection (R upper arm).									U	10/16/2008	10/17/2008	1		PUB	PVT		(+) toenail fungus	Diabetes; HTN			1						1	Injection site cellulitis	FLU3~SANOFI PASTEUR~89975~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~066AX~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329077	10/17/2008	FL	39.0	39		F		Patient received injection at about 3 pm and between 5-6 pm started getting fever, scratchy throat. Between 6-7 pm sx of throat closing and vomiting. Patient seen and treated.				Y					Y	10/15/2008	10/15/2008	0		PVT	PVT		None				1						1	Pyrexia; Throat irritation; Throat tightness; Vomiting	FLU3~SANOFI PASTEUR~U2755AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329080	10/17/2008	TX	36.0	36		F	10/17/2008	Shortness of breath, temp of 103 degrees, left arm deltoid with edema, redness, warm to touch, ROCEPHIN IM in ER and KEFLEX 500 mg 1 po TID x 10 days, Naproxen DS 550 mg.				Y						10/09/2008	10/10/2008	1	CBC; BMP; referral to infectious disease for recommendations on other immunizations in the future.	OTH	OTH	Estradiol; NEXIUM	None	PERCOCET; Hydrocodone; Splenectomy 1978			1						1	Body temperature increased; Dyspnoea; Erythema; Full blood count; Laboratory test; Oedema peripheral; Skin warm	FLUX~UNKNOWN MANUFACTURER~85906~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0224X~3~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0329519	10/17/2008	CO	18.0			F	10/14/2008	Information has been received from a healthcare worker concerning an 18 year old female with no pertinent medical history or allergies who on 12-SEP-2008 was vaccinated intramuscularly with a 0.5 mL fourth dose of GARDASIL (lot #661530/0575X). The dates of administration and the lot numbers for the previous 3 doses of GARDASIL were unknown. Concomitant therapy included influenza virus vaccine (unspecified). Subsequently the patient experienced arm pain, in an unspecified arm. The patient was seen at the office, no laboratory or diagnostics tests were performed. At the time of this report, the outcome was unknown. Additional information has been requested.				Y					U	09/12/2008			None	OTH	OTH			None		WAES0809USA02618	1						1	Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~0575X~4~IM~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0330471	10/17/2008	CA	15.0	15		F	10/14/2008	Information has been received from a physician concerning a female patient who was vaccinated with GARDASIL vaccine (yeast). Per the physician, the patient's mother reported that the patient used to have regular periods and now she is having periods every 2 weeks after receiving GARDASIL vaccine (yeast). At the time of this report, the adverse event is ongoing. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/14/2008; 1/7/2009. Follow-up information has been received from the reporting administration physician concerning a 16 year old female student with asthma and acne and a history of right otitis media, left otitis media. Who on 25-JUL-2007 received her first dose of GARDASIL (Lot# 656371/0161U) intramuscularly in the left arm. Concomitant vaccination administered on 25-JUL-2007 included the second dose of varicella virus vaccine live and a dose of MENACTRA. On 25-SEP-2007 received the second dose of GARDASIL (Lot# 658636/1063U) intramuscularly in the left arm. Concomitant vaccinations administered on 25-SEP-2007 included DTaP and a 0.5 ml dose of influenza virus vaccine (unspecified). On 19-OCT-2007 the patient was administered a dose of DTaP. On 25-JAN-2008 at 16:15 was vaccinated with her third dose of GARDASIL (lot# 659653/1448U) intramuscularly in the left arm. On 16-DEC-2007 the patient visit the office for an ear pain (from 04-DEC-2007) and still she could not hear, and mild upper respiratory infection symptoms and right thumb tenderness. The diagnosis was otitis media and asthma. The patient went to the office on 04-JAN-2008 with continued right thumb pain but with the asthma better. On 25-JAN-2008, the patient was seen for her third dose of the vaccine but she was sick with a sore throat and ear ache. The diagnosis was right otitis media and the patient was prescribed amoxicillin 500 mg. On 08-FEB-2008, the patient was seen because she was sick and for an ear check and the diagnosis was persistant right otitis media. The patient was prescribed AUGMENTIN 875 mg and Biaxin. On 08-AUG-2008, the patient developed an upper respiratory infection, without strep which was treated with albuterol HFA inhaler 2 puffs every 4-6 hours for wheezing. On 21-JUL-2008 the patient experienced constant period every two & 1/2 weeks and premenstrual stomach pain with each cycle. The patient was instructed to monitor her menstrual cycle history daily for 3 months listed as follow: 21-JUL-2008, 10-AUG-2008, 29-AUG-2008, 17-SEP-2008 and 03-OCT-2008 lasting 5-6 days each period. It was noted that the patient was regular prior to vaccination series with GARDASIL. It was also noted that the patient's menarche occurred 1 week before her 14th birthday and she had no history of sexual activity was not presently sexually active. The patient was referred to a gynecologist and seen on 14-OCT-2008. On 06-NOV-2008 the patient was seen at the reporting physician's office and it was noted the patient was started on oral contraception (unspecified) for the treatment of acne. The outcome was noted to be not recovered for constant menstruation and unknown for the patient's premenstrual stomach pain. It was noted that the patient had been seen for multiple visits for sports physical examinations for swimming and water polo activities. Follow-up noted in 2 weeks for patient to receive influenza virus vaccine (unspecified). Additional information is not expected.				Y					N	09/25/2007	12/04/2007	70	Unknown; throat culture, 08/11/08, negative; body weight measurement, 01/25/08, 127; body weight measurement, 02/08/08, 128; body weight measurement, 08/08/08, 123; body weight measurement, 11/06/08, 124; body weight measurement, 10/06/08, 123	PVT	PVT	Unknown; albuterol sulfate, puff	Dull tympanic membrane; Earache; Sore throat; Tympanic membrane erythema; Asthma; Acne	Unknown; Otitis media; Immunisation		WAES0809USA04170	1						1	Abdominal pain upper; Asthma; Ear pain; Malaise; Menstrual disorder; Oropharyngeal pain; Pain in extremity; Streptococcus test negative; Tenderness; Upper respiratory tract infection; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~1063U~2~IM~LA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0330492	10/17/2008	MD	14.0			F	10/14/2008	Information has been received from a registered nurse concerning a 14 year old female who on 17-SEP-2007 was vaccinated with the first dose of GARDASIL vaccine 0.5 ml, IM, on 24-SEP-2008 was vaccinated with second dose of GARDASIL vaccine (lot no. 660618/0572X) 0.5 ml, IM. Concomitant therapy included MENACTRA and FLUMIST. On 24-SEP-2008. 5 minutes after vaccination, the patient passed out and fell to the floor hitting the head. The nurse also reported that the patient had what looked like a little seizure, the patient was hypotensive. The patient was transferred to the emergency room. The head computed axial tomography performed was negative (head normal). The patient was not admitted in the hospital. The patient recovered and was discharged home. The emergency room diagnosis was syncope. Additional information has been requested.				Y					Y	09/24/2008	09/24/2008	0	Computed axial - head normal	UNK	UNK			None		WAES0809USA04486	1						1	Computerised tomogram normal; Convulsion; Fall; Head injury; Hypotension; Immediate post-injection reaction; Loss of consciousness; Syncope	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0572X~2~IM~UN~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0330844	10/17/2008	FL	5.0	5		M	10/10/2008	Fever 103 axillary, frontal headache, muscle ache arms, rash on torso.									Y	10/07/2008	10/08/2008	1	dermatology consult	PVT	PVT		Exanthen	NKOA			1						1	Headache; Myalgia; Pyrexia; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500544P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0329033	10/18/2008	MN	64.0	64		F	10/18/2008	Pt reprots she had Hives on her neck, stomach and leg area 5 hours after receiving the flu inactivae injection on 10/17/08. Pt felt itchy all over her body. Report no other sx and no new changes in her daily routine besides the flu shot. Pt states her hives have gone a way this am and after here reading her VIS sheet, she was insturted to call in to the clinic. Pt has had flu shots in previous years with no side effects.									Y	10/17/2008	10/17/2008	0	None	PVT	UNK						1						1	No reaction on previous exposure to drug; Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua381aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0329034	10/18/2008	CA				U	10/18/2008	Had flu shot at 11:00a.m. 10-17-08.  At 1pm I was feeling very warm.  At 6pm starting chocking at dinner, couldn't catch my breath. Thought it was the perfume from person next to me. Then began Wheezing at vomited. At 7:30pm went to sleep for night. Woke up once noticed wheezing still. Got up at 8:30a.m. 10-18-08 wheezing, couldn't take deep breath, coughed a lot.  Coughed up some plem a few times. Drank a glass of water.  Started to calm down. By 10:18a.m. all wheezing seemed to disappear.  Never when to doctor. Husband got flu shot this morning brought paper with this email address, thought I should complete this form.									Y	10/17/2008	10/17/2008	0		UNK	UNK	ARMOUR, Nasarel, Hydrclorathyozide	Graves Disease	Sulfides			1						1	Cough; Dyspnoea; Feeling hot; Increased upper airway secretion; Vomiting; Wheezing	FLUX~UNKNOWN MANUFACTURER~~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329035	10/18/2008	PA	39.0	39		F	10/18/2008	I woke up this morning feeling just fine, and I have not been sick, nor did I feel like I was getting sick.  I went to get a  flu vaccine this morning around 11:30 am. at my local store.   Following the vaccine, I felt normal tenderness in the location of the vaccine. I finished my errands and went home around 1:30 pm, at which time I noticed a few very obvious adverse reactions.   My face is flushed and hot to the touch and temp is 99.7.  My eyes feel watery, red and irritated.  My brain somehow feels like it has expanded, making my upper jaw feel very strange and enlarged.  My nose feels strange as well...and my head overall feels like there is a vise grip on it.  It is a strange tightening feeling, and it extends down the back of my neck.   I have a metallic taste in my mouth.  I called my family doctor's answering service and spoke to the doctor on call around 2:45.  She told me to take ibuprofen, and drink fluids, and said it is probably not due to the vaccine...but that if other symptoms should develop, I could call her back or go to the ER for evaluation. I do not feel that the symptoms I am having are a normal reaction to the vaccine, and I am concerned.  On my receipt,it says that the manufacturer of this vaccine is fluzine--which was not a choice in your list below, which is why I didn't choose a manufacturer.										10/18/2008	10/18/2008	0		UNK	UNK	adderall xr, synthroid, claritin, singulair, adderall, xyrem, zyrtec	none	seasonal allergies, sulfa allergy, sensitivity to latex adhesive, sensitivity to preservatives such as MSG, IBS, Fibromyalgia, Hashimoto's Thyroiditis, and Narcolepsy.			1						1	Body temperature increased; Dysgeusia; Eye irritation; Feeling abnormal; Flushing; Injection site pain; Lacrimation increased; Muscle tightness; Ocular hyperaemia; Pyrexia; Skin warm	FLU3~SANOFI PASTEUR~89882~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329036	10/18/2008	MA	4.0	4		M	10/18/2008	sneezing, cough, puffy eyes, watery eyes, wheezing, skin turned red from head to toe, hives, lathargy				Y					U	10/18/2008	10/18/2008	0		PVT	UNK		none	Tetralogy of fallot (repaired), reactive airway disease			1						1	Erythema; Eye swelling; Lacrimation increased; Lethargy; Sneezing; Urticaria; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0329039	10/18/2008	TX	51.0	51		M	10/18/2008	3-4 hrs after vaccination began low grade fever, aches, and heavy coughing. 24 hrs later and it has all gotten worse. My wife and daughter have the same.									U	10/17/2008	10/17/2008	0		UNK	PVT		none				1						1	Cough; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~unknown~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329040	10/19/2008	PA	11.0	11		F	10/19/2008	Pt. was given gardasil 10/15/08 at 1700 hrs,  immediately fainted and body jerked once body went limp from fainting. I believe Pt. had a seizure.  Within hours, suffered from severe abdominal pain where pt was guarding abdominal.  Clinic contacted 1000 hours on 10/16/08.  Instructed to return Pt to office at 1300 hrs. Pt was placed on bland diet and prescribed pedilite, and zantac 75 mg bid.  2330 hours, Pt. suffered severe abdominal pain and taken to hospital.  Pain rated 9 out of 10.  Given Lidocaine to numb pain,  no labs were performed.  Pt described pain as, Pain is like when your foot falls asleep and you feel pins and needles in your foot.  Only the pain is much worse,  like 10 times worse.  Pt. is still have abdominal pain.  10/24/08 office note received from PCP with vax rec.  11/10/08 ER record received for 10/16/2008 with Dx: Abdominal pain. Pt presented with c/o abdominal pain since receiving vax 1 day prior. Pt reportedly fainted after the HPV injection and then developed severe abdominal pain described as pins and needles. PE WNL. Tx with Maalox/Lidocaine po with improvement and d/c home.				Y					U	10/15/2008	10/15/2008	0		UNK	UNK	non	annual physical	allergies: corn, wheat, soy, peanuts, pencillin,.  HX, under developed CNS, tremors in hands,  mood disorder, oppositional defiant disorder, PMH:  Asperger Syndrome.  multiple food allergies.  PCN allergy.  Allergic conjunctivitis. Muffled mood			1						1	Abdominal pain; Abdominal rigidity; Convulsion; Dyskinesia; Hypotonia; Immediate post-injection reaction; Paraesthesia; Syncope	FLU3~SANOFI PASTEUR~U2811AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1487U~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2549AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TD~AVENTIS PASTEUR~U2022AA~2~IM~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~1134X~2~IM~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0329042	10/19/2008	AL	42.0	42		M	10/19/2008	Immediately following shot I developed fever, muscle aches, runny nose, cough. Flu like symptoms!										10/18/2008	10/18/2008	0	novortis  lot#89882	UNK	PVT		none				1						1	Cough; Immediate post-injection reaction; Influenza like illness; Myalgia; Pyrexia; Rhinorrhoea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0329043	10/19/2008	FL	65.0	65		F	10/19/2008	Started by week feeling. Throat felt as if closing, coughing trying to catch breath. Lips felt tingling and numb (this would come and go).				Y					Y	10/18/2008	10/18/2008	0	emergency room gave ekg to rule out heart and blood work	UNK	UNK	Levothyroxine 0.125 mg	None	Dairy, mold, dust, some grass (bermuda)trees, tomatoes			1						1	Asthenia; Blood test; Cough; Dyspnoea; Electrocardiogram; Hypoaesthesia; Paraesthesia oral; Throat tightness	FLUX~UNKNOWN MANUFACTURER~8~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0329044	10/19/2008	NJ	66.0	66		F	10/19/2008	Day of vaccination arm was so sore I could not lift it high enough to brush my teeth.  The following morning the upper arm became violently red and hot to the touch.  During the day it seemed to calm down but on Saturday morning the area was most of the upper arm and I went to ER at Community Hospital.  The doctor gave me a perscription for an antibiotic and instructions to take them IF it worsened but did not think it was celulitis.  I purchased the Rx but on Sunday the redness had mostly turned to yellow bruising so I did not take the Rx.				Y					Y	10/16/2008	10/17/2008	1		UNK	UNK	Synthroid; Lipitor; Travatan; Aspirin	None	None	None~ ()~~0.00~Patient		1						1	Contusion; Erythema; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~U2847AA~7+~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1005F~2~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0329045	10/19/2008	CA	54.0	54		F	10/19/2008	PT REPORTS FEELING FLUSHED & ITCHY ABOUT 10 MINUTES AFTER INJECTION, THEN THE FOLLOWING DAY EXPERIENCING HEADACHE, NAUSEA AND FATIGUE WHICH KEPT HER IN BED FOR THE NEXT FEW DAYS. SYMPTOMS RESOLVED AFTER A WEEK OR MORE. SHE DID GO TO AN URGENT CARE FACILITY & REPORTS BEING ASSURED IT WAS A REACTION TO FLU IMMUNIZATION.									Y	10/07/2008	10/07/2008	0		PVT	PVT	NONE	NONE	NONE			1						1	Activities of daily living impaired; Fatigue; Flushing; Headache; Immunisation reaction; Nausea; Pruritus	FLU3~SANOFI PASTEUR~U2757AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329046	10/19/2008	MO	22.0	22		F	10/19/2008	fever documented at 38.8C (101.8F) within 3 hours post vaccination, treated with acetaminophen, persisted approx. 7 hours; frequent vomiting began 4 hours post vaccination with over 20 instances, ceased after 10 hours; extreme lethargy and irritability also noted									Y	10/15/2008	10/15/2008	0		UNK	UNK	Nexium, Lo/ovral	none	allergies to: latex, kiwi, oranges, pineapple, milk, shellfish, fennel			1						1	Irritability; Lethargy; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2786CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329047	10/19/2008	AL	28.0	28		F	10/19/2008	Patient recieved vaccine.  Approximately 45min later patient complained of generalized itching.  At this time 50mg of oral diphenhydramine was given.  10 mins later patient begin to break out in hives. 50mg of IM diphenhydramine was given and paramedics called.  Upon arrival of paramedics patient had normal vital signs and symptoms hives and itching were disappering. Patient refused any additional medical care.									Y	10/13/2008	10/13/2008	0	BP and HR taken by paramedics- Within normal limits.	UNK	PVT	unknown	none	Allergies to Sulfa drugs, dairy products, and peanuts.			1						1	Blood pressure normal; Heart rate normal; Pruritus generalised; Urticaria	FLU3~SANOFI PASTEUR~U2750AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329048	10/19/2008	GA	57.0	57		F	10/19/2008	Difficulty breathing, shortness of breath, unable to take deep breaths. High blood pressure.				Y					Y	10/08/2008	10/08/2008	0		PUB	UNK		None	None			1						1	Dyspnoea; Hypertension	FLUX~UNKNOWN MANUFACTURER~~1~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0329049	10/19/2008	GA	47.0	47		M	10/19/2008	Severe nausia, violent chills, fever for 24 hours10									Y	10/02/2008	10/02/2008	0		PUB	UNK		None	None			1						1	Chills; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329050	10/19/2008	AK	52.0	52		F	10/19/2008	10-15-08 light fever 99.7 then starting around 11pm chills & fever 103.1 with body aches. 10-16-08 1:00pm seen by nurse red, swollen, warm & tender to touch approx. 6 X 9 cm area on upper left arm, temp 99.7 and advise to take ibuprofen and place cool packs to arm. 10-17-08 11am fever resolved, tenderness & redness resolving, no body aches									Y	10/14/2008	10/15/2008	1	none	PUB	PUB	none until adverse effects from vaccine then ibuprofen	none	none			1						1	Body temperature increased; Chills; Erythema; Oedema peripheral; Pain; Pyrexia; Skin warm; Tenderness	FLU3~SANOFI PASTEUR~U2807AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1383U~2~ID~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329051	10/19/2008	AK	57.0	57		F	10/19/2008	10-15-08 7:00am feeling chills, fatigue, arm tender. 9:00am seen by nurse left upper arm warm & tender to touch, red & swollen area approx 6 X 8cm. Advised to take ibuprofen & place cool packs on red area. 10-17-08 Feeling almost normal with red/tender area resolving.									Y	10/14/2008	10/15/2008	1	none	PUB	PUB	none except ibuprofen after adverse effects of vaccine began	none	none			1						1	Chills; Erythema; Fatigue; Oedema peripheral; Pain in extremity; Skin warm; Tenderness	FLU3~SANOFI PASTEUR~U2807AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0803U~2~ID~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329052	10/20/2008	CA	64.0	64		F	10/20/2008	Increasing tightness of throat, red rash all over body but most pronounced on trunk, headache, stomach discomfort, dry mouth. Injection was at 11 am. at the Pharmacy.  I was aware of the beginning of the rash around the injection site around 8 pm.  Unable to sleep.  Realized that I needed to go to urgent care at 6:15 am due to thickness in throat causing very hoarse voice and red rash on body. Went to Urgent Care Department at 7 am.  Received IV Saline with 3 injections of medication.  One was benedryl.  Don't recall the other two.  Stayed in urgent care until my throat loosened up (about 1 1/2 hours).  Went home with prescriptions for Prednisone, Ranitidene HCL, and Zyrtec.  At the time of this report, 10:30 pm, red rash continues. The throat is resolving.  Dry mouth is resolving.  Headache has resolved.  11/11/08 Reviewed ER medical records of 10/19/2008. FINAL DX: allergic dermatitis & throat swelling likely due to flu shot Records reveal patient experienced generalized raised morbilliform maculopapular rash, throat swelling, voice hoarse, abdominal bloating.  Tx w/antihistamine & steroids.  Improved & d/c to home on tapering steroids			Y	Y					Y	10/18/2008	10/18/2008	0		UNK	UNK	Calcium Citrate, Glucosamine/Chrondroitin, Centrum multiple vitamin, Wal-Zyr (generic Zyrtec)	None	Iodide, general inhalants, sensitivity to epinephrine for dental work, no medical conditions except some inhalant allergies (grass, trees)  PMH: Skin cancer, postmenopausal, cervical polyp, stress, allergic rhinitis, hives. Allergy to iodides, epi & watermelon.			1						1	Dry mouth; Dysphonia; Headache; Injection site rash; Rash erythematous; Rash generalised; Sleep disorder; Stomach discomfort; Throat tightness	FLU3~SANOFI PASTEUR~U2803AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0329111	10/20/2008		27.0			M	10/17/2008	Information has been received from a pharmacist concerning a 27 year old male with no medical history or drug allergies reported, who on 13-OCt-2008 was vaccinated with PNEUMOVAX 23 (Lot # 660718/0551X). Concomitant therapy included influenza virus vaccine (unspecified). The patient was admitted to the hospital because he developed tachycardia along with aspiration pneumonia and vomiting after receiving PNEUMOVAX 23. Laboratory tests performed included comprehensive metabolic panel, hepatic enzyme and cell blood count (results not provided). At the time of this report, on 14-OCT-2008, the patient was not recovered. Tachycardia along with aspiration pneumonia and vomiting were considered to be disabling. Additional information has been requested.					Y	0	Y	Y	N	10/13/2008			Unknown	OTH	OTH			None		WAES0810USA02464	1						1	Full blood count; Hepatic enzyme; Metabolic function test; Pneumonia aspiration; Tachycardia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0551X~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation,Disabling	Influenza
0329134	10/20/2008	TX				F	10/20/2008	This case was reported by a healthcare professional (also the consumer) and described the occurrence of fever in a female subject of unspecified age who was vaccinated with Flu vaccine (manufacturer unspecified). Approximately ten years ago, the subject received a dose of Flu vaccine (unknown). An unspecified amount of time following vaccination with flu vaccine, the subject developed fever and chills. The subject additionally missed work for a period of three days. At the time of reporting the events were resolved. In the reporter's opinion, the events of fever and chills were probably related to treatment with flu vaccine. A year later, the subject received the flu vaccine again and had a similar reaction. For details concerning this case, see suffix case A0751658A.				Y				Y	Y				UNK	OTH	OTH		Unknown	A year later, the subject received the flu vaccine again and had a similar reaction. For details concerning this case, see suffix case A0751658A.		A0751658B	1						1	Chills; Impaired work ability; Pyrexia; Vaccine positive rechallenge	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0329138	10/20/2008	CO	0.5	0	.5	M	10/17/2008	Seizure x 2, prolonged seizures, required multiple doses of rectal DIAZEPAM to stop. Admitted to hospital. Normal labs/Head CT but very mild temp to 100 degrees F was noted.   11/3/08-ED records received for DOS 10/15/08-presented with C/O witnessed new onset seizure with fixed gaze and right side arm/leg tickling. Generalized tonic-clonic seizure. Afebrile in ED. Discharged home from ED. DX-Seizure.				Y					U	10/14/2008	10/15/2008	1	Normal CBC, normal UA, normal CSF, normal head CT scan 11/3/08-blood and urine culture no growth.	PVT	PVT		None	None			1						1	CSF test normal; Computerised tomogram normal; Convulsion; Full blood count normal; Scan brain; Urine analysis normal	DTAPIPVHIB~SANOFI PASTEUR~C3181AA~1~IM~UN~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~U275AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C46480~3~IM~UN~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0329139	10/20/2008	GA	58.0	58		F	10/16/2008	Began with stiff neck.  Had trouble speaking, could not say words also was drooling.  Gradually better over hours to days.									Y	09/30/2008	10/03/2008	3		OTH	PVT			HTN; Hyperlipdemia			1						1	Drooling; Musculoskeletal stiffness; Speech disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA180AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0329141	10/20/2008	PA	52.0	52		F	10/17/2008	10/16/08 Pain/ tenderness at site left deltoid. Redness at site- 10/17/08 Increasing redness + warmth at site.  c/o nausea 10/16/08 in PM No emesis- appetite decreased.  Facial redness and warm feeling.  -> instructed by ED physician- apply ice/increase fluid intake.  10/19/08 No further complaints.										10/15/2008	10/16/2008	1	Temp-oral at 0845 10/17/08-  98.4 degrees	PUB	PVT	OTC- Geritol tablets	Unknown	Unknown	Nausea~Influenza (Seasonal) (Fluarix)~0~50.00~In Patient|Nausea~Influenza (Seasonal) (Fluarix)~0~0.00~In Sibling		1						1	Body temperature; Decreased appetite; Erythema; Feeling hot; Injection site erythema; Injection site pain; Injection site warmth; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA367CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0329142	10/20/2008	CO	54.0	54		M	10/18/2008	Low blood pressure low heart rate/pulse dizziness, sweating, pale color treated with O2 by paramedics									Y	10/17/2008	10/17/2008	0		OTH	OTH	Metformin, Lipitol					1						1	Dizziness; Heart rate decreased; Hyperhidrosis; Hypotension; Oxygen supplementation; Pallor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89971~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0329143	10/20/2008	IL	75.0	75		F	10/20/2008	States she had vomiting, dizziness, and a temp of 98.9 for 1 hr. on 10/16/08									Y	10/15/2008	10/16/2008	1		UNK	UNK		None				1						1	Body temperature; Dizziness; Vomiting	FLU3~SANOFI PASTEUR~V2786AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329145	10/20/2008	KS	53.0	53		F	10/17/2008	Redness, soreness, edema at injection site. fever, chills, Myalgia. Taking Advil for discomfort 10/20/2008 9:45am.									Y	10/16/2008	10/16/2008	0		PUB	PVT	Cortisone injection in foot 3 weeks ago	No	Asthma			1						1	Chills; Discomfort; Injection site erythema; Injection site oedema; Injection site pain; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U2810AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0867X~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329148	10/20/2008	MA	56.0	56		F	10/14/2008	Chills,  fever,  malaise , shaking for 24 hrs, no cough. Had urisx prior to vaccine, Chest congestion no sore throat, no cough. Everything after injection 10/08/2008									N	10/08/2008	10/08/2008	0		PUB	UNK	None	Yes - Uri				1						1	Chills; Malaise; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329151	10/20/2008	MA	59.0	59		F	10/20/2008	1 hr after vaccine - dev throat tightening, headache, 24-48 hrs of congestion, eyes swollen.									Y	10/11/2008	10/11/2008	0		OTH	UNK	Claritin; Simvastatin; Flonase	Denies	Seasonal allergies; ? Latex allergy; Hyperlipidemia			1						1	Eye swelling; Headache; Throat tightness; Upper respiratory tract infection	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA359BA~2~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0329152	10/20/2008	WA	46.0	46		F	10/13/2008	Patient developed hives, Headache, Tachycardia and flushing. The following day she was seen in the emergency room and received Zantac 300mg, Prednisone  60mg and Vistaril 50mg  IM. She was placed on a tapering dose of prednisone for home use.				Y					Y	10/06/2008	10/06/2008	0		PUB	PVT	Robaxin Hydrocodone Fluxetin Premarin	No	Shell fish, Penicillin, Clarithromycin, Bactracin- all cause hives.	Hives~Measles + Mumps (no brand name)~UN~6.00~In Patient		1						1	Flushing; Headache; Tachycardia; Urticaria	FLU3~SANOFI PASTEUR~U2793EA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329153	10/20/2008	ID	68.0	68		F	10/13/2008	Welts Bilateral arms upper body				Y					U	10/10/2008	10/13/2008	3		OTH	PUB	Lovastatin, Didofenac, Omeprazole					1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0329154	10/20/2008	IN	65.0	65		F	10/10/2008	Chills, fever, muscle and joint aches, arm throbbing, BP 180 /90  P-197 (per pt report), nausea and dry heaves.  Pt had all Sx at home, not seen by healthcare provider.  Sx resolved after 4 hrs.									Y	10/07/2008	10/07/2008	0		OTH	PVT	None		Hx - rapid  heart rate; zero meds presently			1						1	Arthralgia; Chills; Myalgia; Nausea; Pain; Pyrexia; Retching	FLU3~CSL LIMITED~02649111A~UNK~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0329155	10/20/2008	NV	74.0	74		F	10/10/2008	She immediately felt the needle go in. She felt the vaccine go in her deltoid. She felt some pain and she felt a sensation of the vaccine affecting her thumb. there was some numbness and pain in her thumb and deltoid lasting 8 days to date.										10/02/2008	10/02/2008	0		OTH	PVT						1						1	Hypoaesthesia; Immediate post-injection reaction; Injection site pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89620~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0329156	10/20/2008	MI	67.0	67		M	10/10/2008	Received influenza injection 10-7-08 at 11:30 AM.  By 2:30 AM, 10-8-08, was having difficulty swallowing.  Went to ER.  Symptoms resolved by 5:30 AM.  No treatment.				Y					Y	10/07/2008	10/08/2008	1		PVT	PVT	None	None	None			1						1	Dysphagia	FLU3~SANOFI PASTEUR~U2820AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329157	10/20/2008	CT	51.0	51		F	10/13/2008	phone call to VMA @ 3:30pm.  Patient c/o heart palpitations 1.5 hrs after vaccine administration, approx 1:00 pm.  Itching of throat, thick saliva began 3:00pm.  Informed patient she needs to go to ER or Report incident to MD, then be advised by MD.  MD instructed her to go to ER.  BENADRYL drip was started in ER, RCW +kg PRENISONE X 5 days.				Y						10/06/2008	10/06/2008	0		OTH	PVT			Peanut, pet dander			1						1	Palpitations; Saliva altered; Throat irritation	FLU3~SANOFI PASTEUR~U2751AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329158	10/20/2008	NV	49.0	49		F	10/14/2008	Area of left upper arm measuring 3 x 2 1/2 - pink, warm to touch and slightly firm.  Patient describes it as sore. Area of injection is not included in this area and is slightly echymotic.									U	10/09/2008	10/10/2008	1		PUB	OTH	ZYLOPRIM;  ASA;  LOVENOX;  LEXAPRO;  PREMARIN;  TRICOR;  ATIVAN; NICOTINE GUM	Chest pain; Hx of Lymphoma with stem cell transplant	Sulfa drugs;  Lymphoma with transplant			1						1	Ecchymosis; Erythema; Induration; Pain in extremity; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA374BA~3~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0329160	10/20/2008	OR	61.0	61		F	10/12/2008	About 2-3 hrs. after shot all my joints and muscles began aching.  As the day went on I fell worse, In the middle of the night I woke up with extreme chills- no fever- and felt like the onset of flu.  This continued throughout the next day.  I felt like I have been run over by a truck.  I have never had any reactions before other than a sore arm.  I called the pharmacy the next day.  I don't want any compensation etc.  I just thought you folks should know.									Y	10/01/2008	10/01/2008	0	None	OTH	PVT	Lanoxin estrodise	None	None	none~Influenza (Seasonal) (no brand name)~~0.00~Patient		1						1	Arthralgia; Chills; Influenza; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329161	10/20/2008	PA	2.0	2	.1	F	10/14/2008	Patient received FLUMIST on 10/09/2008.  Approx.  6 hrs later she developed hives on abdomen and a swollen lower lip.  seen in ER after giving BENADRYL and Sx then gone.				Y					Y	10/09/2008	10/09/2008	0		PVT	PVT	None		None			1						1	Lip swelling; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500556P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0329166	10/20/2008	FL	45.0	45		F	10/13/2008	Hives, GI sx. Still recovering Anaphylactic reaction, gastritis				Y						10/03/2008	10/03/2008	0		PVT	OTH						1						1	Anaphylactic reaction; Gastritis; Gastrointestinal disorder; Urticaria	FLU3~CSL LIMITED~02649111A~UNK~~~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0329168	10/20/2008	HI	4.0	4		M	10/13/2008	Redness and hardness to injection site the next day, mother also noted patient scratching area.  Redness 2.5 inches.									Y	10/11/2008	10/12/2008	1		PUB	PUB		None				1						1	Injection site erythema; Injection site induration; Injection site pruritus	FLU3~SANOFI PASTEUR~U2769AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329169	10/20/2008	FL	65.0	65		F	10/11/2008	Red, Hot, and itchy left deltoid 6 hrs									Y	10/10/2008	10/10/2008	0	None	PVT	PVT	None	Cellulitis	None			1						1	Erythema; Pruritus; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA171AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0329170	10/20/2008	IA	4.0	4		M	10/15/2008	FLUZONE administered 9am 10/14/08 onset hives 7pm 10/14/08 BENADRYL with short term relief									Y	10/14/2008	10/14/2008	0		PVT	PVT	Claritin	None	None			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2761AA~5~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329171	10/20/2008	CA	60.0	60		F	10/15/2008	Pain at the time of injection with gradually increasing severity, Increased swelling. Ibuprofen and codeine unable to reduce extreme pain. Unable to move shoulder for several  days. Massive swelling (upper arm) subsided after 48hours. Large echymoses appealed									Y	10/07/2008	10/07/2008	0	None	UNK	UNK		None				1						1	Ecchymosis; Injected limb mobility decreased; Injection site pain; Oedema peripheral; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA349BB~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0329172	10/20/2008	FL	69.0	69		F	10/13/2008	Cellulitis like rxn. Rx Augmentin 500 BID x 7 days. Medrol dose pak.									Y	10/09/2008	10/10/2008	1		OTH	UNK		None				1						1	Cellulitis	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0329173	10/20/2008	CA	1.2	1	.2	M	10/16/2008	Patient received flu shot 10-11-08, started running a fever 10-12-08.  Tempture of 105 on 10-13-2008, vomited one time on 10-13-08.				Y					Y	10/11/2008	10/12/2008	1		PVT	PVT						1						1	Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~UT276SCA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329174	10/20/2008	CA	1.1	1	.1	F	10/15/2008	Patient received flu vaccine 10-11-08 and began running a fever 10-12-08 PM to 104. Patient was seen in office 10-13-08 ad had febrile sz. Pt was transported to hospital and received abx inj 10-14-08 after BC (+).				Y					Y	10/11/2008	10/13/2008	2	UA neg; Bld culture (+) gm Nes cocci	PVT	PVT	None	None	UTI			1						1	Blood culture positive; Febrile convulsion; Pyrexia; Urine analysis normal	FLU3~SANOFI PASTEUR~UT2785CA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329175	10/20/2008	NY	44.0	44		F	10/16/2008	Arm red with sore edema at shot area									Y	10/14/2008	10/15/2008	1		PVT	PVT		None				1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~U2759AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329177	10/20/2008	OR	3.0	3		F	10/15/2006	Per mom on 10-06-08 : Stated child developed fever of 105.2 within 24hrs of vaccines. Took in ER 3 days later with 5x of URI, cough, runny node, conjunctive excudate, UTI R/O. No site Reaction  .				Y					Y	02/26/2008	02/27/2008	1		PUB	PVT			Reported Milk Allergy		OR200831	1						1	Conjunctivitis; Cough; Pyrexia; Rhinorrhoea; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~UT2475AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAUB2~2~IM~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1216F~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1510U~2~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0329182	10/20/2008	OR	20.0	20		F	10/10/2008	c/o (R) arm very sore from her ear to her hand, pain level 0-10 scale at 7 also c/o pink tonsil, sputum when she coughs. Has red spots of blood in it too. Sx stared evening after Pneumonia shot. Cough comes intermittently about 5 times since 10/08/08. Can't take Ibuprofen or TYLENOL since Kidney transplant (not antihistamine suppressants)									Y	10/07/2008	10/08/2008	1	No visible redness or swelling noted	PUB	PVT	Unknown	None	Kidney transplant-with own kidney moved from site of other site		OR200828	1						1	Haemoptysis; Pain in extremity; Productive cough; Tonsillar inflammation	FLU3~SANOFI PASTEUR~U2758AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0224X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329205	10/20/2008	NC	45.0	45		F	10/20/2008	Fever, myalgias, arthralgias.  Progressed to dropping things at first from right hand and then left hand.  Had difficulty driving in particular braking.				Y					N	10/13/2008	10/13/2008	0	Called employee health and told symptoms not related to vaccine.  Seen by PCP on 10/17 and was nasal swab negativefor infuenza.  Felt to be just a viral illness.  Seen in Emergency department on 10/19, were EKG, CXR and CT brain were normal.  ABnormal labs included a H/H of 11.3/32.8, the WBC count was normal at10.8, but the differential but monocytes elevated at 10.  The Sodium was low at 134, SGOT was elevated at 44 and alk Phos at 149.  The albumin was low at 2.5.  I) had to leave work and plan to see my PCP today(10/20/08)	PVT	UNK	Altace, Zocor, Synthroid, Wellbutrin, Rozerm, Zegreid, celebrex	none	Amoxicillin, Bextra, Hydroxyzine, Imitrex, Maxzide,			1						1	Arthralgia; Aspartate aminotransferase increased; Blood albumin decreased; Blood alkaline phosphatase increased; Blood sodium decreased; Chest X-ray normal; Computerised tomogram normal; Culture negative; Electrocardiogram normal; Grip strength decreased; Haematocrit decreased; Haemoglobin decreased; Impaired driving ability; Influenza serology negative; Monocyte percentage increased; Myalgia; Pyrexia; Scan brain; White blood cell count normal	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~IM~LL~HEP A (NO BRAND NAME)~1|UNK~UNKNOWN MANUFACTURER~~UNK~SC~RA~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0329208	10/20/2008	IL	58.0	58		M	10/20/2008	Aches experienced same day of inoculation. After 3 days of subclinical symptoms, systemic symptoms experienced. Fever of 99-100 for over 2 days with continual headaches, myalgia, weakness, nasal congestion and inability to concentrate.									U	10/14/2008	10/14/2008	0		PUB	PUB						1						1	Asthenia; Disturbance in attention; Headache; Myalgia; Nasal congestion; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329210	10/20/2008	OH	50.0	50		F	10/20/2008	Painful left arm within 45 minutes of shot.  Numbness and tingling started later that evening and was especially bothersome and painful the next morning, 10/10/08.  I said to my co-workers that I thought I was having a stroke.  Numbness in chest is significant.  Cannot feel collarbone area on left side.  Calf and thigh of left leg burn and tingle.  Ankles are numb.  Toes are numb, worse depending on foot/leg placement.  5/8/09 neurology records received DOS 10/17/08-3/13/09. FINAL DIAGNOSIS: Acute demyelinating encephalomyelitis (mild) Post-vaccination discomfort, numbness left shoulder. Numbness then spread to left arm, chest and leg. Diagonal diplopia and lightheadedness. Altered sensation to pinprick and light touch - left leg and anterior thorax. Left hip flexor weakness. New-onset headaches several months later. Intermittent arm and leg pain. Weakness noted left leg. Diplopia, hypertropia.				Y					N	10/09/2008	10/09/2008	0	Neurologist visit 10/17/08.  CT scan of head 10/21/08, lumbar puncture 10/31/08.  I am unable to have a MRI due to a piece of metal in my ear status post stapedectomy years ago.  So far, the neurologist is saying transverse myelitis.  Prognosis is unstated at this time.  The symptoms might get better, they also might not.  I am very unhappy with this outcome.  5/8/09 neurology records received DOS 10/17/08-3/13/09. LABS and DIAGNOSTICS: Lumbar puncture - oligoclonal bands inderminant for MS but may indicate inflammation. CT Head - Normal.  CT Cervical Spine - mild degenerative neural foraminal stenosis.	UNK	UNK	I do not currently take any prescribed medications.	None.	NKDA.  No allergies diagnosed. R stapedectomy			1						1	Burning sensation; Hypoaesthesia; Lumbar puncture; Myelitis transverse; Neurological examination abnormal; Pain in extremity; Paraesthesia; Scan brain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89684~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0329211	10/20/2008	NC	12.0	12		F	10/20/2008	Vomiting x one day									Y	10/14/2008	10/14/2008	0	none	PVT	PUB	Ritalin, Trazadone, Clonidine	none	ADHD, Autistic,			1						1	Vomiting	FLU3~SANOFI PASTEUR~u2795ea~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329212	10/20/2008	FL	48.0	48		F	10/20/2008	At injection site, took shot on Friday, by Saturday morning, was achy all over, entire arm where injection took place felt as though someone had hit me with a board, very sore could hardly use the arm, today Monday the 20th I still have a hard 3 inch in diameter spot, red, very itchy.									U	10/17/2008	10/18/2008	1		UNK	PVT						1						1	Injected limb mobility decreased; Injection site erythema; Injection site induration; Injection site pain; Injection site pruritus; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329217	10/20/2008	WI	54.0	54		F	10/20/2008	Itchiness and scab on skin where shot administered; heart beat faster than usual by abt 10 beats/min; weakness; general awful feeling, headache, dizziness									U	10/15/2008	10/16/2008	1		PVT	PVT				Nausea, weakness, dizziness~Influenza (Seasonal) (Fluzone)~1~3.90~In Patient		1						1	Asthenia; Dizziness; Feeling abnormal; Headache; Heart rate increased; Injection site pruritus; Injection site scab	FLU3~SANOFI PASTEUR~u2740aa~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329218	10/20/2008	OH	51.0	51		F	10/20/2008	Rash at site of injection LD given im. Rash moved down arm to back and then all body. When health dept called on 10 17/08 it was resolving. Did not go to Dr. or ER.									Y	10/10/2008	10/10/2008	0		PUB	PUB		Heart Condition	IODINE noted			1						1	Injection site rash; Rash generalised	FLU3~SANOFI PASTEUR~u2768aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329219	10/20/2008	AR	65.0	65		F	10/20/2008	Pneumococcal vaccine given on 10-18-08 at approx. 1530.  Associate came back to the Infection Control office on 10-20-08 at 0900 with erythema, warmth, swelling and induration at injection site. Associate also reported a fever on the prev. day.									Y	10/18/2008	10/18/2008	0		PVT	UNK						1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~87877 2P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0979X~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329220	10/20/2008	NY	36.0	36		F	10/20/2008	Employee states she developed itching and hives approximatley 20 minutes after receiving Influenza vaccine. Developed on hands, neck, face and was seen in the emergency room at hospital where employed.				Y					Y	10/10/2008	10/10/2008	0	Treated in the Emergency room with Solumedrol and Benadryl and released	UNK	PVT	None	Denies	Denies			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2764AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329224	10/20/2008	CA	47.0	47		F	10/20/2008	Swollen tongue, numbness of tongue, sore throat, difficulty swallowing, body aches, stomach upset, puffiness,									Y	10/16/2008	10/16/2008	0		UNK	PVT	none	none	none			1						1	Dysphagia; Hypoaesthesia oral; Pain; Pharyngolaryngeal pain; Stomach discomfort; Swelling; Swollen tongue	FLU3~CSL LIMITED~02649111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0329225	10/20/2008	AZ	10.0	10		F	10/20/2008	Site of injection became hot and swollen.  Client took her daughter to the doctor who diagnosed a Strep infection related to the injection site.				Y						10/17/2008	10/19/2008	2		PUB	UNK						1						1	Injection site swelling; Injection site warmth; Streptococcal infection	FLU3~SANOFI PASTEUR~U2806AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0789X~5~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0329226	10/20/2008	FL	64.0	64		F	10/20/2008	Developed rash over back, chest, abdomen, upper arms, thighs, fever 104.  Started within 24 after injection.  Physician ordered steroids, cream and benadryl.									Y	10/02/2008	10/03/2008	1	None	MIL	UNK	ASA, Vitumins	no	none			1						1	Pyrexia; Rash	FLU3~CSL LIMITED~0194911A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0329227	10/20/2008	CA	43.0	43		M	10/20/2008	Patient returned day after vaccine with erythema at site of vaccine and also with urticaria on arms, legs, chest and neck. Patient had previous flu vaccine with no reaction.				Y					U	10/16/2008	10/17/2008	1		UNK	UNK		none	none			1						1	Injection site erythema; No reaction on previous exposure to drug; Urticaria	FLU3~SANOFI PASTEUR~U2808AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329228	10/20/2008	OH	56.0	56		F	10/20/2008	Received vaccine @ 2:15pm At 9:00 pm client describes having a hard time breathing/ heart beating fast/ headache and extreme lethargy. called ER did not go had no transportation. Symptoms seemed to be subsiding by 11:00 pm but remained very tired client stated.site has very large red area around it and sore to the touch.advisedto seek medical attention for follow up of symptoms.									Y	10/17/2008	10/17/2008	0		PUB	PUB			alllergy to Vioxx			1						1	Dyspnoea; Fatigue; Headache; Heart rate increased; Injection site erythema; Injection site pain; Lethargy	FLU3~SANOFI PASTEUR~u2832aa~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329229	10/20/2008	MD	56.0	56		M	10/20/2008	On 14 October I received a flu shot at my work from the traveling team.  I am a retiree and was authorized to get the shot.  It was administered by injection in my left arm by an individual.  I started noticing some swelling and small dark red areas as well as some yellow areas of the skin a few days ago.  Today is day six and the yellow area appears to be spreading down my arm and the red spots seem more pronounced. Today I visted Clinic to ask someone to take a look at it. LTC will see the patient. She said that he will not have to take any more flu shots. This is a moderate reaction.				Y						10/14/2008	10/16/2008	2		MIL	MIL	none	none	none	none~ ()~~0.00~Patient		1						1	Erythema; Swelling; Yellow skin	FLU3~CSL LIMITED~01449111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0329231	10/20/2008	MO		57		F	10/20/2008	Client reports vaccine administered approximately 9 AM.  At approximately 1315 PM client began to coughing and could not get the episode under control.  She reports her chest tightening and it became difficult to breath, then a tightening type pain in her jaws. Eyes became very bloodshot. Paramedics were called and client was transported via ambulance to the closest hospital one hour away.  The following test were preformed; CAT Scan, Doppler Study, X-rays, Kidney function test, Chemical Stress test and other unknow blood test were done, all test were negative.  Client recieve nitro and steriods while in the ER.  Client sent home the same evening, symptons subsided late that evening.				Y					Y	10/14/2008	10/14/2008	0	Client reports it was an allergic reaction to something.	PUB	PUB	Prozac and Betapace	none	none			1						1	Blood test normal; Cardiac stress test; Chest discomfort; Computerised tomogram normal; Cough; Dyspnoea; Hypersensitivity; Ocular hyperaemia; Pain in jaw; Renal function test normal; Ultrasound Doppler normal	FLU3~SANOFI PASTEUR~U2802AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329233	10/20/2008	IA	76.0	76		F	10/20/2008	Was given the shingles shot on Wednesday, October 15.  Noticed on the 16th the site was red and was beginning to itch me.  Tried not to let it bother me, thinking this would only last a few days, but between the 16th and today, the 20th, the redness traveled around my arm, through the arm pit moving closer to my right breast, and up the right side of my neck.  It also appeared at the bend of the elbow.  The area is swollen and itches intensely!  Had no rise in temperature. Went to my doctor who prescribed the following:  Hydroxyz HCL 25 mg tablets Glen, cephalexin 500 mg cap.Ranb,and Prednisone 10 mg tablets West									N	10/15/2008	10/16/2008	1		UNK	PVT	Fosamax, Toprol XL 50 MG and vitamins		I have an allergy to metal and sulfa.			1						1	Erythema; Injection site erythema; Injection site pruritus; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~8014553~UNK~UN~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0329236	10/20/2008	CA	26.0			M	10/20/2008	Redness ans sewlling to sight diminished with in 24 hours.				Y					Y	10/15/2008	10/15/2008	0	First time receiving the vaccine.No labs drawn.ER Physcian felt no treatment necessary.	PVT	PVT	none	none	none			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329237	10/20/2008	MA	17.0	17		F	10/20/2008	Patient received flu shot on 9/26/08, 3 days later right arm was swollen, red, warm to touch, itchy and had a rash at the site of injection. She came to clinic on 10/20/08 and was treated with benadryl and prednisone 60mg po daily x 3 days.									N	09/26/2008	09/29/2008	3	None	PVT	UNK	Singulair, Advair 500/50, albuterol, anaprox	None	Asthma, allergies,NKDA			1						1	Erythema; Injection site rash; Oedema peripheral; Pruritus; Skin warm	FLU3~SANOFI PASTEUR~U2766AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329240	10/20/2008	NC	87.0	87		F	10/17/2008	Patient presented with the following adverse events moments after the vaccine was administered at  approximately 2:25pm.                                          -Perspiration, loss of mobility in right arm, inability to stand, confusion, nausea/vomiting, slurred speech, neck pain.                                             Patient was given the following treatment upon onset of symptoms beginning at approximately 2:30pm:                                           -Removed outer jacket and fanned patient to try to cool down, kept patient seated in chair with head upright, attempted BP check with little success, checked blood glucose (see section 12), continued trying to gather any information from patient regarding history of symptoms, allergies, medications, called EMS at approximately 2:35pm after seeing no improvement in symptoms.				Y					U	10/17/2008	10/17/2008	0	Blood glucose taken at 2:37pm: 112 mg/dL	UNK	PVT	Obtained from other pharmacy: Lanoxin, warfarin, diltiazem	Reported as none by patient prior to vaccination.	Reported by patient prior to vaccination as heart failure.			1						1	Blood glucose; Confusional state; Dysarthria; Dysstasia; Hyperhidrosis; Monoplegia; Nausea; Neck pain; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89738~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0329241	10/20/2008	UT	49.0	49		F	10/20/2008	Several hours later I felt like my heart was pounding way too hard and fast.  I felt very out of breath and dizzy.  My voice gets hoarse and I feel weak and sick.  I did not have these problems before the shot and do not have a family history.  I specifically asked for and wrote down a request for the 'fresh' shot without the preservatives as discussed with my doctor, but the nurse gave me the wrong shot by mistake.				Y					N	11/02/2007	11/02/2007	0	Abnormal EKG.  Heartrate was too fast.	PUB	UNK	None	None	Mercury, methiolate			1						1	Asthenia; Dizziness; Dysphonia; Dyspnoea; Electrocardiogram abnormal; Heart rate increased; Malaise; Palpitations	FLUX~UNKNOWN MANUFACTURER~000~1~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0329243	10/20/2008	WA	65.0	65		F	10/20/2008	Extreme pain, erythema, heat and induration distal to injection site (13x13 cm).  Onset slowly increasing within 4 hours of injection. Currently 16+ hours post injection									Y	10/19/2008	10/19/2008	0		PVT	PVT		None	Not assessed			1						1	Erythema; Induration; Pain in extremity; Skin warm; Injection site erythema; Injection site rash; Injection site swelling; Injection site warmth; Oedema peripheral	FLU3~SANOFI PASTEUR~U2768AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~9733401-196~2~IM~RA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~196ou 7/26/09~UNK~~~PNEUMO (NO BRAND NAME)~2	USA		Influenza
0329244	10/20/2008	IN	53.0	53		F	10/20/2008	about 48 hours after injection, patient complained of pain in shoulder, lack of movement of shoulder .  Tx unknown.  Pt reports symptoms decreased with time and near normal movement on 10/18/08				Y					Y	10/03/2008	10/05/2008	2		UNK	PVT	Unknown	None Known	diabetes, kidney disease. tetanus toxoid allertgy listed by patient			1						1	Injected limb mobility decreased; Musculoskeletal pain	FLU3~CSL LIMITED~02349111a~UNK~IM~LL~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0329245	10/20/2008	AZ	4.0	4		M	10/20/2008	weakness, fever, wheezing, fast heartbeat, sore throat for 24 hours. Given  Tylenol 1 1/2 tsp.									Y	10/16/2008	10/18/2008	2	none	PVT	UNK		none	none			1						1	Asthenia; Heart rate increased; Pharyngolaryngeal pain; Pyrexia; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0329249	10/20/2008	GA	1.0	1	.0	M	10/20/2008	Developed C-Pox, Rash				Y					Y	10/07/2008			None	PVT	UNK						1						1	Varicella	FLU3~SANOFI PASTEUR~UT2782EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0955X~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0329250	10/20/2008	VA	76.0	76		F	10/20/2008	At 6:30 pm went out to dinner in restaurant.  Felt hot, dizzy and nauseated (did not eat) and vomited once.  Went for check up in ER.  BP normal.  No more problems.									Y	10/15/2008	10/15/2008	0		PUB	PUB	Metroprolol 50mg 1am 1/2 pur; Chlorthalidone 25mg 1/2 po; Zoloft 50mg 1 po qd; Levothyroxine 112mg 1 po qd; Colchisine 0.6mg 1 po qd; Simvastin 40mg 1 po qd; Norvasc 5mg 1 po qd; Amytriptilene 10mg 1 po bedtime	None	Triple by-pass, Hypertension, Anxiety, High Cholesterol, Thyroid			1						1	Dizziness; Feeling hot; Nausea; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89750~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0329251	10/20/2008	PA	76.0	76		M		Patient presented to pharmacy on 10-18-08 stating he had cellulitis from his shot and wanted to know what we were going to do about it.  Verified per VAR firm that it was the PNEUMOVAX-23 in the left arm.  Arm was red, swollen and marked off with marker from the ER doctor.  Filled prescription for generic Keflex 500mg and generic Bactrim DS.  Patient paid for them.				Y					U	10/16/2008	10/17/2008	1		OTH	OTH		None	None			1						1	Cellulitis; Erythema; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89884~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0990U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0329252	10/20/2008	MD	7.0	7		M	10/20/2008	local swelling and erythema				Y					U	10/18/2008	10/19/2008	1	None	PVT	PVT		None	None			1						1	Erythema; Swelling	FLU3~SANOFI PASTEUR~U2804AA~4~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329253	10/20/2008	MA	62.0	62		F	10/20/2008	Local reaction redness and swelling (L) Delt Body aches, flu like symptoms, chills for 48 hours. Also started LOVASTATIN for Chol and is still having chills, leg cramps.									Y	10/15/2008	10/15/2008	0	hypercholesterolemia; Restless Legs Syndrom	PVT	PUB		None				1						1	Chills; Erythema; Hypercholesterolaemia; Influenza like illness; Local reaction; Muscle spasms; Oedema peripheral; Pain; Restless legs syndrome	FLU3~SANOFI PASTEUR~U2811AA~7+~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1960U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C3029AA~UNK~UN~RA~TDAP (ADACEL)~1	USA		Influenza
0329254	10/20/2008	MS	51.0	51		F	10/20/2008	Extreme Pounding / intense pain in left upper arm muscular area where injection was given has not decreased  in 5 days and  increases with arm movements .									N	10/15/2008	10/15/2008	0		OTH	UNK						1						1	Injection site pain; Pain	FLU3~SANOFI PASTEUR~u2791AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329255	10/20/2008	MS	48.0	48		M	10/20/2008	I received the flu vaccination on 10/15/08 in the atrium of NASA bldg 1100.  I experienced more than normal pain at the injection site and now am experiencing numbness on the upper portion of the left bicep.										10/15/2008	10/15/2008	0		OTH	UNK	? Nexium or similar	No				1						1	Hypoaesthesia; Injection site pain	FLU3~SANOFI PASTEUR~U2791AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329256	10/20/2008	MS	53.0	53		F	10/20/2008	Headache, Sneeze, Earache, Sore throat, Nauseous, Coughing and running nose.										10/15/2008	10/15/2008	0	None	OTH	OTH						1						1	Cough; Ear pain; Headache; Nausea; Pharyngolaryngeal pain; Rhinorrhoea; Sneezing	FLU3~SANOFI PASTEUR~U2791AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329257	10/20/2008	PA	48.0	48		F	10/20/2008	Has cold, shiver, aches, the fever up to 102. Stayed in bed. Nausea, R rib pain.				Y					Y	10/07/2008	10/08/2008	1	slight LFTs	PVT	PVT		None	on allergy shots; HTN, COPD			1						1	Chills; Feeling cold; Liver function test abnormal; Musculoskeletal chest pain; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~U2762AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329260	10/20/2008	CA	60.0			F	10/20/2008	Flu vaccine on 9/25/08.  Pain at injection site after 24 hours.  Symptoms of Tendonitis.  Still painful approximately 1 month later.  Limits ROM above shoulder one month later.  Will see doctor if persists.									N					UNK	UNK						1						1	Injected limb mobility decreased; Injection site pain; Tendonitis	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329261	10/20/2008	CA	69.0	69		M	10/20/2008	Got Flu shot on 9/25/08: Pain at injection site like sore muscle- Difficulty moving arm and shoulder past a certain point (upwards)										09/25/2008	09/25/2008	0		OTH	PVT	LIPITOR					1						1	Injected limb mobility decreased; Injection site pain; Myalgia	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329262	10/20/2008	NM	65.0	65		F	10/20/2008	65 year old patient received HEP A & B in left deltoid and Typhim VI fluvirin in right deltoid on 4/16/08.  Flu HEP B 5/15/08.  Patient did not report symptoms until 10/15/08 - presently pain, decreased ROM - chest exam consistent with brachial right tendonitis.  *Note patient has significant history for repetitive movement - Navajo rug weaver and swimming.									U	04/16/2008	04/16/2008	0	None	PVT	UNK	Fosamax; Calcium	None known	Arthritis			1						1	Injected limb mobility decreased; Pain in extremity; Tendonitis	FLU3~SANOFI PASTEUR~U2512AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB521BA~1~IM~LA~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB224BA~7+~IM~LA~HEP A (HAVRIX)~1|TYP~SANOFI PASTEUR~A0923~2~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0329263	10/20/2008	NE	51.0	51		F	10/20/2008	Pt reported dizziness, light headedness in about 15-20 minutes following vaccination. Also reported feeling headache coming on 1/2 hour after vaccine.									Y	10/20/2008	10/20/2008	0		OTH	OTH		None				1						1	Dizziness; Headache	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0329264	10/20/2008	SC	47.0	47		M	10/20/2008	Patient Reported Half dollar size bruise on arm approx 12 hrs after injection with moderate s0reness, Protocol Physicians nurse said to use warm compress and Tylenol pm,  Adult.									U	10/19/2008	10/20/2008	1		OTH	PUB	Trileptol,Keppra, Percocet, clonazepam,  Avinza, Meclizne , Gubadntu	None				1						1	Contusion; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881327P~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~15410~UNK~IM~RL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0327850	10/21/2008	TX	34.0	34		F	10/07/2008	A serious, study report of tongue numb, tongue swollen, itchy skin and splotchy skin was received from an investigator, concerning a 34 year-old female patient enrolled in study H-21853, subsequent to FLUMIST.  At the time of the event, she had nasal allergies.  Concomitant medications included ALLEGRA-D, bupropion, triamcinolone acetonide and birth control pills.  The patient has a history of an allergy to ragweed.  The patient received FLUMIST, intranasal on 02-Oct-2008.  Within an hour of receiving FLUMIST, the patient complained her tongue was getting numb and swollen and becoming itchy and splotchy.  She was treated with diphenhydramine 25 mg by mouth but refused additional diphenhydramine or EPIPEN.  EMS arrived and administered intravenously 25 mg of diphenhydramine.  She was subsequently taken to the emergency department and by the time she arrived she was feeling better.  She never experienced hypotension, wheezes, stridor or respiratory distress.  The patient was discharged home on diphenhydramine, 25 mg by mouth every six hours until midnight.  The events were considered resolved.  The investigator assessed the events as serious and related to FLUMIST.				Y					Y	10/02/2008	10/02/2008	0	known date, Physical exam, no results provided	OTH	OTH	ALLEGRA D, WELLBUTRIN, NASACORT, birth control pill		nasal allergies; ragweed allergy		MEDI0007234	1						2	Hypoaesthesia oral; Pruritus; Rash macular; Swollen tongue; Hypoaesthesia oral; Pruritus; Rash macular; Swollen tongue	FLUN3~MEDIMMUNE VACCINES, INC.~500556P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500556P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Emergency room visit	Influenza
0329012	10/21/2008	ME	43.0	43		F	10/15/2008	Facial Erythema and edema, symptoms of shortness of breath, fatigue.				Y					U	10/07/2008				PVT	PVT					NE00908	1						2	Anxiety; Arthralgia; Asthenia; Chest discomfort; Choking; Cough; Crying; Differential white blood cell count; Dyspnoea; Ear discomfort; Eye discharge; Eye irritation; Eye pruritus; Fatigue; Headache; Local swelling; Mumps antibody test positive; Ocular hyperaemia; Platelet count; Pruritus; Red blood cell count; Retching; Sensation of heaviness; Swelling face; Tremor; White blood cell count; Dyspnoea; Erythema; Face oedema; Fatigue	FLU3~SANOFI PASTEUR~U2790AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2790AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0329243	10/21/2008	WA	65.0	0	.0	F	10/21/2008	Arm swelled at injection site and spread to elbow.  Was hot and had red rash.										10/19/2008	10/19/2008	0		PUB	UNK	Premarin					1						2	Erythema; Induration; Pain in extremity; Skin warm; Injection site erythema; Injection site rash; Injection site swelling; Injection site warmth; Oedema peripheral	FLU3~SANOFI PASTEUR~U2768AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~9733401-196~2~IM~RA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~196ou 7/26/09~UNK~~~PNEUMO (NO BRAND NAME)~2	USA		Influenza
0329248	10/21/2008	AR	56.0	56		M	10/21/2008	10 hours after receiving vaccine I experienced a fever of 101.3, weakness and dizziness. I went to sleep and the fever was gone 6 hours later.									Y	10/17/2008	10/17/2008	0		UNK	UNK		no	none			1						1	Asthenia; Dizziness; Pyrexia	FLUX~UNKNOWN MANUFACTURER~7/24/08~5~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329267	10/21/2008					U	10/21/2008	We received the following information from the above mentioned literature article on 06 OCT 2008: During the 2004-2007 influenza seasons, influenza-associated pediatric deaths were analysed. Of 90 children who were recommended for influenza vaccination, only 5 (6%) were fully vaccinated. 18 children were at least partially vaccinated more than or equal 14 days before illness onset per season, respectively. One child who was partially vaccinated did not have either an age related or ACIP defined high-risk condition recommended for vaccination. The reason for death was not reported for individual cases. Influenza-associated pediatric mortality and/or bacterial coinfection were suspected. The author will be contacted for details. Children with high risk condition (asthma, seizure disorder, neuro/vesicular disorder). One child without any risk conditions. Causality not related. Causes of death for individual cases not identifiable, complications of influenza and bacterial coinfections were mentioned.  Expectedness assessment according to product information: Partial vaccination is unexpected.  Vaccination failure is expected.  Bacterial coinfections and influenza complications are unexpected after vaccination with FLUVIRIN, BEGRIVAC, FLUAD and AGRIPPAL.  On a case level, the case is considered unexpected.  No change in benefit-risk-ratio.  No measures necessary.	Y								N					OTH	OTH	No other medications	Children with high risk condition (asthma, seizure disorder, neuro/vesicular disorder)	One child without any risk conditions.		MA20082210	1						1	Death	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0329301	10/21/2008	OH	2.0	2	.3	F	10/16/2008	FLUMIST was administered in a dose of 0.2mL to patient 10/08/2008.  On 10/09/2008 patient was seen at hospital for fever, lethargy, tachypnea.  Referred to ER for further evaluation and treatment.  CXR read as patchy atelectasis vs. RML infiltrate.  Seen in follow up at hospital on 10/10/2008 and remained febrile, lethargic, and tachypneic.  Patient received albuterol in office on 10/09/2008.  Once in ER was given albuterol/ATROVENT X2.  Was discharged on zithromax and albuterol MDI.  Further follow up is pending.  10/31/08 Reviewed PCP office records of 10/8-10/20/2008 which included ER records of 10/9. FINAL DX: RML pneumonia Records reveal patient was in good health on day of vaccine & had not had reaction to previous flu vaccine.  RTC 10/9 w/fever, chills, decreased appetite, decreased activity, difficulty sleeping, crying, fatigue, irritabity, malaise, runny nose, moist cough, wheezing, diarrhea, generalized boy aches/pains, reduced urine output.  Sick contact at home w/common cold s/s.  Exam noted rales & rhonchi bilaterally, wheezing & intercostal retractions.  Tx w/nebs & sent to ER.  Tx w/oral antibiotics & nebs.  D/C to home on continued antibiotics & nebs.  Developed abdominal pain & crying after eating, irritable, diarrhea.  Sent to radiology & thought to be ileus vs early obstruction.				Y					U	10/08/2008	10/09/2008	1	CXR read as patchy atelectasis vs. RML infiltrate.  LABS: CXR abnormal & c/w RML pneumonia.  Stool c/s & OB neg.  WBC 23.7(H), plts 639(H), neutros 22%(H), lymphs 17(L).  CRP 5.09(H).  Blood c/s neg.	UNK	UNK						1						1	Chest X-ray abnormal; Lethargy; Pyrexia; Tachypnoea	FLUN3~MEDIMMUNE VACCINES, INC.~500557~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0329302	10/21/2008	TX	8.0	8		F	09/28/2008	My daughter had the FLUMIST on last Wed 9/23/08 at 4:30 pm about 2 hours later she started complaining of aching and headache. Got up on Thursday 9/24/08 morning and called doctors office they told me to bring was diagnosed with a sinus infection. The symptoms got worse called doctor back she called her in TYLENOL 3 and it barely took the headaches and aching away. Friday 9/25/08 she cried for hours she was hurting so had she then had a stomach plus all other symptoms and she felt like she had to throw up she was hot then cold so we took her to the emergency room and the doctor there diagnosed her with having adverse side effects from the FLUMIST. He put her on LORTAB and ZOFRAN. Saturday 9/2/608 she was still hurting stomach and headache. The LORTAB just numbed the pain but did not make it go away. Took her back to the emergency room on Saturday 9/27/08 this time to a different hospital. They ran blood work did a contrast MRI of her head all the way to her abdomen and everything came back normal. He said it must be some adverse reactions to the FLUMIST. He advised to let you know and see if you had any suggestions for the relieve of symptoms and see if you have had other cases. Please let me know. I am desperate. Thanks. 10/27/08-ED records received for DOS 9/26/08-left without being seen. ED visit 9/27/08-C/O headaches, stomach ache and aches all over began 45 minutes after Flumist. PCP diagnosed symptoms as allergic reaction to FLumist.				Y						09/23/2008	09/23/2008	0	9/26/08, urinalysis, came back normal-Hospital; 9/27/08, blood work, came back normal-other Hospital; 9/27/08, contrast with dye MRI, came back normal- Hospital  10/27/08-records received- CSF normal, gram stain no growth. CT abdomen and pelvis no acute intra-abdominal. Scattered subcentimeter lymph nodes, nonspecific. CT brain mild ethmoid disease. CT face and sinuses, mild thickening of ethmoid sinuses. US abdominal unremarkable. Upper GI unremarkable.	UNK	UNK			None			1						1	Abdominal pain upper; Blood test normal; Crying; Feeling of body temperature change; Headache; Nausea; Nuclear magnetic resonance imaging normal; Pain; Sinusitis; Urine analysis normal; Vaccination complication	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0329306	10/21/2008	OH	52.0	52		M	10/10/2008	cold chills, 104.3 fever, headache, sore throat, rapid heart rate, fatigue, body aches, paleness, hoarseness, cold sores all over, lips, still not completely recovered. (Had swine flu in 1976) -> only flu event ever									Y	10/02/2008	10/02/2008	0		OTH	PVT	BENAZEP/HCTZ 20-12.5 Tab; ZETIA 10 mg, AMITRIPTYLIN 50 mg; GABAPENTIN 300mg; PERCOCETTE	None	Allergic to Bees; Kienbacks Disease (L) wrist			1						1	Chills; Dysphonia; Fatigue; Headache; Heart rate increased; Oral herpes; Pain; Pallor; Pharyngolaryngeal pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89751~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0329308	10/21/2008	PA	20.0	20		F	10/15/2008	Patient was inadvertently given a 1 ml dose of influenza vaccine instead of correct 0.5 ml dose.  Patient reported no adverse events.									Y	10/07/2008				PVT	PVT			Patient is pregnant.  Was 25 wks 2 days when vaccinated.			1						1	Incorrect dose administered; No adverse event	FLU3~SANOFI PASTEUR~U2758AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329309	10/21/2008	MI	45.0	45		F	10/15/2008	Woke up achy next day- had 5d of abdominal pain, headache and diarrhea.  Did vomit x2 the day after administration of LAIV.									Y	10/02/2008	10/03/2008	1		PVT	UNK			GERD;  Hypothyroid			1						1	Abdominal pain; Diarrhoea; Headache; Pain; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500S43P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0329311	10/21/2008	PA	29.0	29		F	10/15/2008	Pt was inadvertently given 1ml of FLUZONE instead of correct 0.5 ml dose.  Pt reported a sore arm X 6 days but no other adverse events.  Soreness  has resolved now.									Y	09/30/2008	10/01/2008	1		PVT	PVT			Pt is pregnant.  Pt was 37wks 1 day when vaccinated.			1						1	Incorrect dose administered; Pain in extremity	FLU3~SANOFI PASTEUR~U2758AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329312	10/21/2008	GA	28.0	28		F	10/17/2008	Itchy eyes, numbness in face and hands, skin redness all over.				Y					Y	10/06/2008	10/06/2008	0	None	PUB	OTH	None	None	None			1						1	Eye pruritus; Generalised erythema; Hypoaesthesia; Hypoaesthesia facial	FLU3~SANOFI PASTEUR~U2760AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329314	10/21/2008	PA	28.0	28		F	10/15/2008	Patient inadvertently given double dose (1ml instead of 0.5ml) of vaccine. Patient notified,  reported no adverse events. Denied skin reaction at the site.									Y	10/07/2008				PVT	PVT		None	None			1						1	Incorrect dose administered; No adverse event	FLU3~SANOFI PASTEUR~U2758AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329315	10/21/2008	PA	31.0	31		F	10/15/2008	Patient was inadvertently given 1ml of influenza vaccine, instead of  0.5ml correct dose. Patient reported no skin reaction or adverse events.									Y	10/07/2008				PVT	PVT		None	Patient is pregnant, was 29 wks 2 days when vaccinated.			1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~V2758AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329316	10/21/2008	PA	34.0	34		F	10/15/2008	Patient was inadvertently given 1 ml of influenza vaccine instead of correct 0.5 ml dose.  Patient reported no adverse events.									Y	10/07/2008				PVT	PVT			Patient is pregnant.  Patient was 30 wks 4 days when vaccinated.			1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~U2758AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329317	10/21/2008	PA	33.0	33		F	10/15/2008	Patient inadvertently received  a 1ml dose of influenza vaccine instead of correct 0.5 ml dose. Patient reported her arm was sore a few days but has resolved.									Y	10/08/2008	10/09/2008	1		PVT	PVT			Patient is pregnant, was 16 wks 2 days when vaccinated.			1						1	Incorrect dose administered; Pain in extremity	FLU3~SANOFI PASTEUR~U2758AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329318	10/21/2008	PA	35.0	35		F	10/15/2008	Pt was inadvertently given 1ml of FLUZONE (instead of correct 0.5 ml dose).  Pt said arm was itchy intermittently x 1 wk but it has resolved.									Y	09/30/2008	09/30/2008	0		PVT	PVT			Pt was pregnant at 34 wks 3 days when vaccination give.			1						1	Incorrect dose administered; Pruritus	FLU3~SANOFI PASTEUR~U2758AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329319	10/21/2008	PA	35.0	35		F	10/15/2008	Patient was inadvertently given 1 ml of influenza vaccine instead of correct dose (0.5 ml).  Patient reported that her arm was sore x 1 wk but has resolved.									Y	09/24/2008	09/25/2008	1		PVT	PVT			Patient is pregnant - 19 wks 4 days at time of vaccination.			1						1	Incorrect dose administered; Pain in extremity	FLU3~SANOFI PASTEUR~U2758AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329320	10/21/2008	MD	6.0	6		F	10/13/2008	Erythema and swelling left arm at site of flu vaccine.  2 x 2 inches left upper arm site of flu injection.				Y					Y	10/10/2008	10/11/2008	1	None	PVT	UNK			Asthma; non allergic rhinitis; #10 Pneumo			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2805AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329321	10/21/2008	MN	31.0	31		F	10/15/2008	Patient reports pain in her right arm going down to her inner elbow from the injection site.										10/15/2008	10/15/2008	0		PUB	PVT						1						1	Injection site pain; Pain in extremity	FLU3~SANOFI PASTEUR~UZ772AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329323	10/21/2008	MT	5.0	5		F	10/16/2008	Received intranasal live influenza vaccine at flu clinic on 10-15-08 at 1515.  1/2 hour later, she started to get welts on her cheeks then it progressed to her hands and feet which were red et edematous.  To the PA at the clinic.  Takes Benadryl 12.5mg PO q 4 hours until rash is gone.  Rash is all over her body.				Y					N	10/15/2008	10/15/2008	0		PUB	PUB		None	None			1						1	Erythema; Oedema peripheral; Rash generalised; Urticaria	FLU3~SANOFI PASTEUR~500560P~2~IN~NS~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329324	10/21/2008	VA	34.0	34		F	10/15/2008	Pain, swelling, redness, hot to touch									U	10/13/2008				MIL	UNK		None	None			1						1	Erythema; Pain; Skin warm; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89976~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0329325	10/21/2008	MN	6.0	6		M	10/15/2008	Had usual nasal rinse for allergies, per mom, approximately seven hours after receiving flu mist on 10/7/08.  Also uses Astelin nasal spray.  Blister noticed 10/11/08, getting worse.				Y						10/07/2008	10/11/2008	4	None	UNK	UNK		None	Rhinitis; Recurrent sinusitis.			1						1	Blister	FLUN3~MEDIMMUNE VACCINES, INC.~500545P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0329327	10/21/2008	WA	56.0	56		F	10/15/2008	within 24 hours of vaccine high fever of 103, headache, very fatigue, chills; red left eye (infection) a few days later.				Y					Y	09/30/2008	10/01/2008	1	None	OTH	PVT	Levothyroxine.50	None	Fibromyalgia			1						1	Chills; Eye infection; Fatigue; Headache; Ocular hyperaemia; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA375BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0329328	10/21/2008	PA	22.0	22		F	10/15/2008	Patient received 1ml dose of influenza vaccine instead of correct 0.5ml dose. Patient reported nothing expect slight soreness at site of injection.									Y	10/06/2008	10/06/2008	0		PVT	PVT			Patient is pregnant, was 22wks, 3days when vaccinated.			1						1	Incorrect dose administered; Injection site pain	FLU3~SANOFI PASTEUR~U2758AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329329	10/21/2008	LA	73.0	73		M	10/10/2008	Bells Palsy - right sided facial weakness since yesterday afternoon.  B/P - 128/76, Pulse - 80, Temp 97.8.  Prednisone 20mg BID x 7d, Valtrex 500mg TID x 7 days.				Y					N	10/07/2008	10/09/2008	2	MRI - WNL	PVT	PVT	Advicor; Metanx; ASA		None			1						1	Body temperature; Facial palsy; Facial paresis; Nuclear magnetic resonance imaging normal	FLU3~SANOFI PASTEUR~U2746AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329331	10/21/2008	CA	2.0	2	.3	M	10/17/2008	Patient received Flu Vaccine on 10/13/08 in our office. Following evening developed fever 105 deg F and Febrile seizure requiring 911 activation of EMS and taken by ambulance to hospital				Y					Y	10/13/2008	10/14/2008	1	Clinical Diagnosis of Febrile Seizure	PVT	UNK		None	None			1						1	Febrile convulsion; Pyrexia	FLU3~SANOFI PASTEUR~UT2782CA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329334	10/21/2008	PA	34.0	34		F	10/15/2008	Pt was inadvertently given I ml dose of FLUZONE instead of correct 0.5m. dose.  Pt reported no skin reaction and no adverse events.									Y	09/24/2008				PVT	UNK			Pt is pregnant.  Was 20 wks 1 day when vaccinated			1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~U2758AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329335	10/21/2008	RI	46.0	46		F	10/16/2008	45 minutes after vaccine administered client c/o L side pain and not feeling well- dizzy and wanting to go to sleep									Y	10/16/2008	10/16/2008	0		OTH	UNK	Synthroid 150 mg, daily;  Cytomil 5mg 2x day		Thyroid dysfunction			1						1	Dizziness; Malaise; Pain; Somnolence	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89738~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0329336	10/21/2008	PA	23.0	23		F	10/15/2008	Pt. was inadvertently given a 1 ml dose of FLUZONE instead of the correct 0.5ml dose.  Pt. reported her arm was a little sore the next day but it has now resolved.									Y	10/07/2008	10/08/2008	1		PVT	PVT			Pt is pregnant.  Was 30 wks 4 days when vaccinated.			1						1	Incorrect dose administered; Pain in extremity	FLU3~SANOFI PASTEUR~U2758AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329337	10/21/2008	PA	34.0	34		F	10/15/2008	Pt was inadvertently given 1 mL dose of influenza vaccine instead of correct 0.5 mL dose. Pt reported chills and rigors on the night of the injection which resolved by morning. Pt reported no skin reaction.									Y	10/08/2008	10/08/2008	0		PVT	PVT		None	Pt is pregnant. Was 15 wks 2 days when vaccinated.			1						1	Chills; Incorrect dose administered	FLU3~SANOFI PASTEUR~U2758AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329338	10/21/2008	PA	24.0	24		F	10/15/2008	Patient was inadvertently given 1ml dose of influenza vaccine, instead of correct 0.5 dose. Patient reports no skin reaction and no adverse events.									Y	10/08/2008				PVT	PVT			Patient is pregnant, patient was 15 wks 5 days when vaccinated.			1						1	Incorrect dose administered; No adverse event	FLU3~SANOFI PASTEUR~V2758AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329339	10/21/2008	WA	71.0			F	10/12/2008	Rcn started approx 1:45 am on 10/11/08-ears began to swell and progressed to cheeks and eventually to throat (soreness). Pt sought medical care approx noon on 10/11 was given BENADRYL- Condition has improved. She will be seeing an allergist for F/u. (Pt has had similar experience with NAPROXEN and DIAMOX)				Y					Y	10/10/2008	10/11/2008	1		OTH	PUB		None	None			1						1	Auricular swelling; Pharyngeal oedema; Pharyngolaryngeal pain; Swelling face	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA366CA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0329340	10/21/2008	NC	48.0	48		F	10/08/2008	Patient complained of light headedness, hot face, grabbed throat, breathing appeared difficult.  Suspected angioedema.  Admin Epi pen 0.6mg at 11:43 am and called EMS.  At 11:45 am patient talked and said was getting better.  ER arrived approximately 11:48 am.  Patient returned to pharmacy P/O ID/C meds 3:07 pm.  Prednisone 40mg QD, Benadryl 25mg Q 6 hours, Pepcid 20mg Q 12 hours for 5 days.				Y					Y	10/03/2008	10/03/2008	0		OTH	PVT	Carbinoxamine 4mg PRN; Lexapro 20mg HS	None	*Unspecified allergies; neg S04 allergy; neg egg/egg protein allergy			1						1	Dizziness; Dyspnoea; Feeling hot	FLU3~CSL LIMITED~02449111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0329341	10/21/2008	MN	3.0	3		M	10/17/2008	Pt with pruritic rash-Hsp. Diagnosed today.									U	10/15/2008	10/15/2008	0		PVT	PVT		URI	None			1						1	Rash pruritic	FLUN3~MEDIMMUNE VACCINES, INC.~500567P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0329342	10/21/2008	TX	5.0			F	10/14/2008	Red papules and vesicles and scabs, indicating primary varicella.									Y		10/13/2008			PVT	OTH	None	None	None			1						1	Blister; Erythema; Rash papular; Scab; Varicella	DTAP~SANOFI PASTEUR~~5~IM~UN~DTAP (DAPTACEL)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~SANOFI PASTEUR~~4~UN~UN~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~~2~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0329343	10/21/2008	MO	77.0	77		M	10/15/2008	Patient stating erythema and swelling to right upper FA, noticed this am; now stating this afternoon decreased swelling and erythema.  Large area still noted to have erythema, swelling; epi compassive most of upper FA (R); denies SOB, CP or difficulty breathing.									Y	10/14/2008	10/14/2008	0	None	OTH	OTH	None	None	None			1						1	Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~U2803AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1161X~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329344	10/21/2008	CO	67.0	67		F	10/08/2008	Received influenza vaccine on 9/29/08.  On 10/4 patient complained arm was still sore.  No swelling, no fever, no rash.  On 10/6 patient returned to pharmacy indicating arm still hurt.									U	09/29/2008	09/30/2008	1	None known	OTH	PVT	Unknown	None				1						1	Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89620~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0329346	10/21/2008	IA	69.0	69		F	10/15/2008	Pt. presents to office with redness inside upper L arm.  States, increasing in size of redness, but was more painful yesterday Redness = approx 6 x 8 Pt. started on KEFLEX 500mg BID x 7 days.									U	10/11/2008	10/12/2008	1	None	PVT	PUB	ASA;  LASIX K+;  ESTRONIPAK;  PRILOSEC;  METROPROLOL, ANTODARONE KEFLEX RESOTOID		Heart valve replacement June 2008			1						1	Erythema; Pain in extremity	FLU3~SANOFI PASTEUR~427890A~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0993U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329349	10/21/2008	IN	22.0	22		F	10/15/2008	Headache, Bell's Palsy right, decreased taste, decreased corneal reflex, increased tearing.  RX: Prednisone 60 qd x 7d, Valtrex 1000 qd x 5d.  (Mother also had Bell's Palsy after Flu shot in past).									U	10/09/2008	10/14/2008	5	None	OTH	PVT	Cymbalta, Fe Sulfate, Adderall, Trinessa					1						1	Corneal reflex decreased; Facial palsy; Headache; Hypogeusia; Lacrimation increased	FLU3~CSL LIMITED~02649111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0329351	10/21/2008	WI	17.0	17		F	10/15/2008	Patient was given MENACTRA SQ instead of IM on 10-14-08									Y	10/04/2008				PVT	PVT	None	None	None			1						1	Incorrect route of drug administration	FLU3~SANOFI PASTEUR~42765AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2637AA~1~SC~~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C3027BA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0329357	10/21/2008	IL	8.0	8		M	10/15/2008	hives, urticaria, redness and swelling (4cm x 8cm) at injection site.  diffuse									Y	10/13/2008	10/13/2008	0		PVT	PVT	SINGULAIR 5mg QD	None	Asthma, Med allergies (OMNICEF)			1						1	Injection site erythema; Injection site swelling; Injection site urticaria	FLU3~SANOFI PASTEUR~U2798EA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329358	10/21/2008	FL	67.0	67		F	10/14/2008	Within 1 hr I observed hives on my body. The next morning I lost consciousness and fell on kitchen floor. I had hives for 3 days.				Y					Y	10/10/2008	10/10/2008	0		OTH	UNK		None	Allergy to grapes.			1						1	Fall; Loss of consciousness; Urticaria; Hypotension; Loss of consciousness; Rash generalised	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~1~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0329361	10/21/2008	MD	9.0	9		F	10/13/2008	Erythema and swelling at site of injection 2 x 1 1/2 inches Lt upper arm. PO Benadryl helping. Local reaction to chicken pox vaccine.				Y					Y	10/10/2008	10/11/2008	1	None	PVT	OTH		None	Arachnoid brain cyst; Obesity			1						1	Injection site erythema; Injection site swelling; Local reaction	FLU3~SANOFI PASTEUR~U2805AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0785X~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0329385	10/21/2008	IA	34.0	34		F	10/21/2008	Received FluMist at approximately 1600.  by 2030, severe coughing, vomiting, diarrhea. By 2200, laryngitis was present.  hives started in the evening, but wghen woke up the next morning, hives were scarrered over body and getting worse.  Went to Dr. who prescribed Prednisone 20 mg BID and Benadryl prn.									Y	10/14/2008	10/14/2008	0	NA	PVT	PVT	None		None			1						1	Cough; Diarrhoea; Laryngitis; Urticaria; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0329386	10/21/2008	PA	52.0	52		F	10/20/2008	Employee received Flu Vaccine on Monday 10-13-08 at approximately 2:00PM.  Employee reports that about 5:00PM she felt as though she were coming down with a fever (not documented).  She reports experiencing sharp pains in her lower legs and thighs. That same evening, employee reports she experienced a terrible headache, and had a low-grade temp. 99.4.  The following morning, 10-14-08, employee states that she experienced a burning sore throat, and mild-to moderate swelling of her mouth, roof of mouth  and underneath her tongue.  She also reports her face was itching. She took Benadryl and Ibuprophen Saw family physician who ordered her a Solu-Medrol Z Pack.  Now employee reports that on Sunday October 19, her Left eye is swollenher face is itching				Y					U	10/13/2008	10/13/2008	0		PVT	PVT	Employee reports she currently takes the following medications;Benadryl 50 mg.at bedtime; Allegra 180mg at bedtime; Cardizem CD 180 mg. at bedtime; Ambien 10 mg as needed.	None at time vaccine was administered.	Breast Cancer			1						1	Eye swelling; Headache; Oedema mouth; Oropharyngeal pain; Pain in extremity; Pruritus; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA171AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0329387	10/21/2008	TX	88.0	88		F	10/21/2008	Afloria used on 10/10/08.  4 days later itchy rash on chest.  Presented today for care for rash.  No other obvious etiology found.  Possible reaction to vaccination.  Rash is still present to date.									N	10/10/2008	10/14/2008	4		PVT	PVT	Enablex 7.5 bid, isosorbide 10 qam, lisinopril 12.5 qd, asa qd, mvi	Vit D deficiency	codeine			1						1	Rash; Rash pruritic	FLU3~CSL LIMITED~02249111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0329388	10/21/2008	NV	68.0	68		M	10/21/2008	REDNESS AND SWEELING FROM SHOULDER TO BELOW THE ELBOW									Y	09/22/2008	09/22/2008	0		MIL	MIL						1						1	Erythema; Oedema peripheral	FLU3~CSL LIMITED~U1463AA~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~1541U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329391	10/21/2008	IA	18.0	18		F	10/21/2008	Redness(APPROX 4.5IN X 3IN AREA), SWELLING AND WARM TO TOUCH L DELTOID AREA, FEVER FROM 99-103, ACHEY.  Cellulitus L arm per Dr-seen 10/21/08.									Y	10/18/2008	10/18/2008	0	WBC-12900	UNK	UNK	Lisinopril, Spironolactone, Furosemide, ASA	None Known	NKDA, Hypoplastic L Heart syndrome			1						1	Cellulitis; Erythema; Oedema peripheral; Pain; Pyrexia; Skin warm; White blood cell count increased	FLU3~SANOFI PASTEUR~U2744AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2566AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PPV~MERCK & CO. INC.~0742X~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2966AA~7+~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0329392	10/21/2008	GA	29.0	29		F	10/21/2008	Tightness in chest, wheezing, pain in gums, swollen lips and eyes, confusion									Y	10/20/2008	10/20/2008	0		PVT	PVT		None	None			1						1	Chest discomfort; Confusional state; Eye swelling; Gingival pain; Lip swelling; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329393	10/21/2008	WI	7.0	7		F	10/21/2008	Dev. blotches with fluid-filled vesicles several hours after administration. Parent gave pt. antihistamines. No rash noted the following day, or since.									Y	10/17/2008	10/17/2008	0	None.	PUB	UNK	None.	Cough.	None.			1						1	Blister	FLU3~SANOFI PASTEUR~500541P~1~IN~NS~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329394	10/21/2008	UT	35.0	35		F	10/21/2008	Heaviness in chest, heart racing, and throat felt like it was tightening up.				Y					Y	10/15/2008	10/15/2008	0	NONE	PUB	PUB	None	None	Exercise enduced Asthma.	None~ ()~NULL~~In Patient		1						1	Chest discomfort; Palpitations; Throat tightness	FLU3~SANOFI PASTEUR~U2769AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329395	10/21/2008	PA	26.0	26		F	10/21/2008	Patient recieved vaccine on 10/18/08 at our store flu clinic. She said that the following day when she woke-up her right arm was very red, warm, and swollen from the shoulder to her elbow. She took Benadrly and Ibuprofen for the swelling and pain but it did not seem to help. She came into the pharmacy on sunday 10/19/08 to show me her arm and I referred her to EPN Urgent care accross the street to have them take a look at it. They told her that she should continue to take Benadryl and Ibuprofen and that it did look like cellulitus but they did not think it was bacterial. They also told her to follow-up with her PCP if it did not provide any relief or got worse after 2 days. Patient stopped by pharmacy yesterday and stated that it was really not getting any better, from my perspective it appeared the same, and she was going to call her PCP to make an appointment. I called the patient today to see what if any progress was made and am currently waiting to hear back.				Y					U	10/18/2008	10/19/2008	1		PUB	PVT		NO	Allergie to Penicillin			1						1	Erythema; Oedema peripheral; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~u2806aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0870x~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0329396	10/21/2008	NE	32.0	32		F	10/21/2008	At or around 2:30pm I was in the salon getting my hair done and started having difficulty breathing, I would cough when breathing out-I was light headed.  It wasn't like I needed to go to the hospital.  Then around 5:30 pm I went home and my eyes started getting red, I started loosing my voice and started getting back pain.  By 8:00pm I was in bed and my husband told me that my eyes looked bloody red-I had no white part in my eyes-freaky!  I didn't go to the hospital because I don't have health insurance.  I went to bed and woke up Sunday morning and I was better.  I want to go to the doctor and make sure that my sight is fine and I have no other reactions I don't know about.  I wonder if I should take the shot next year.										10/18/2008	10/18/2008	0		UNK	UNK						1						1	Back pain; Cough; Dizziness; Dysphonia; Dyspnoea; Ocular hyperaemia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329398	10/21/2008	PA	47.0	47		M	10/21/2008	Patient describes twitching of right eye 1-2 hours of receiveing the flu vaccine. He went to bed early around 8:30pm hoping to see if sleep would help.  twitching remains today. he called the Health Center to report the observation. He is in no distress otherwise. Recommended he call his primary  physician. Health department contacted for advice.  Other than report to private MD, no other advice noted.  VAERS report.  Contact with patient at 11am notes no relief from twitch.										10/20/2008	10/20/2008	0		UNK	UNK		none				1						1	Blepharospasm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88805~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0329399	10/21/2008	FL	29.0	29		F	10/21/2008	Received Fluarix vaccine in left deltoid (lot # AFLUA356AA exp date 5/31/09 at approx 04:30 this am.  States approx 15min later noted pain into neck and radiating down left arm; approx 4 hours later noted raised bumps on both forearms; approx 15 min later petichiae on left arm distal to elbow;  approximately 45 min later noticed progression of numbness into jaw, mouth, head.  Sent to Emergency Room.  Previously received Fluarix in 2005 & 2006 with no adverse reaction.				Y					U	10/21/2008	10/21/2008	0		PUB	UNK	vitamins					1						1	Hypoaesthesia; Hypoaesthesia oral; Immediate post-injection reaction; Neck pain; No reaction on previous exposure to drug; Pain in extremity; Petechiae; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA356AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0329400	10/21/2008	AL				U	10/21/2008	Broke out in hives,the same day,Went to the emergency room,about 6:pm.Recieved a shot and a prescription for Atarax 25mg.   Treated at medical Center.I had Influenza vaccine shot on 10-17-2008. Treated for Hives the same day				Y					N	10/17/2008	10/17/2008	0		UNK	UNK	Etodolac400 mg,propranolol 80 mg,cyclobenzapr 10 mg.,Diovan hct 160/25 mg					1						1	Urticaria; Pruritus; Rash; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA364AA~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA364AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~2|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA364AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~3	USA	Emergency room visit	Influenza
0329401	10/21/2008	CA	23.0	23		M	10/21/2008	Pt received vaccine and was in waiting area for 5 minutes when he noticed a red itchy bump on his R arm.  He reported it to the Immunization staff and was escorted to the ER at MC.  They saw his bump on the way to the ER.  The ER saw him and observed him for a few hours and then released him back to his unit without further treatment or follow up needed.				Y					Y	10/05/2008	10/05/2008	0	N/A	MIL	MIL	None known	Healthy	None Known			1						1	Erythema; Rash pruritic	FLU3~SANOFI PASTEUR~U2832AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329402	10/21/2008	CA	5.0	5		F	10/21/2008	Possible generalized tonic-clonic seizure lasting <5 minutes on 10/10/08 early am.									Y	10/07/2008	10/10/2008	3	EEG pending	PVT	PVT	none	none	none			1						1	Electroencephalogram; Grand mal convulsion	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~B297CA~2~IM~~HEP A (HAVRIX)~1	USA		Influenza
0329403	10/21/2008	MI	66.0	66		F	10/21/2008	small lump and pain day of vaccination-next day very red on upper arm									U	10/20/2008	10/20/2008	0		UNK	PUB	unknown					1						1	Erythema; Injection site mass; Pain	FLU3~SANOFI PASTEUR~U2754AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0867X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329405	10/21/2008	FL	47.0	47		F	10/21/2008	Local site reaction: warm, red, swollen  Left upper arm times 3 days;   No fever                Six days post treatment, 10/20/08, in A.M., patient noted pain and tingling in right hand, traveled to right wrist and arm over course of day; the same evening, same symptoms began in left hand, right foot and right thigh. A.M. of 10/21/08, this deep nerve pain is felt same locations as well as a cinnamon like burning around mouth.  No redness or swelling of face. Also noted at this time, marked heaviness noted in both legs. No swelling, discoloration noted in hands, arms, ankles, or legs. 12/15/2009  MR received from PCP. Pt initially seen for local reaction to flu shot-redness & swelling which resolved in 4 days. Now reporting pain, numbness and tingling in the R hand/arm. Decreased sensation in extremities Impression:  Paresthesia-arms and legs.   Neurology consult 11/3/08 with DTRs hypoactive in arms and legs with normal strength.  Spinal H/A 2' to LP.  Assessment: EMG c/w median and ulnar neuritis.  No evidence of GBS. Probable lumbosacral radicular irritation.				Y					N	10/14/2008	10/20/2008	6	First MD appointment scheduled for 10/22/08 a.m.; no testing to date. Labs and Diagnostics:  EMG (+) for carpal tunnel syndrome and probable lumbosacral radiculitis. MRI brain WNL.  MRA WNL. CSF WNL. Myelin basic protein (-). CSF cx (-). No oligoclonal bands.MRI cervical spine (+) for degenerative changes	UNK	UNK	Topamax 200  H.S.	None	Codiene   Hx of miagrines	none~ ()~~0.00~In Patient|none~ ()~~0.00~In Sibling|none~ ()~~0.00~In Sibling		1						1	Erythema; Local reaction; Neuralgia; Oedema peripheral; Oral discomfort; Pain in extremity; Paraesthesia; Sensation of heaviness; Skin warm	FLU3~SANOFI PASTEUR~U2772AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329406	10/21/2008	NY	46.0	46		F	10/21/2008	Had moderate/severe knee joint pain (both knees) lasting  24-30 hours. Never had knee pain in my life & can not link it to any previous activities. Symptoms began 35-48 hours after immunization. Took Ibuprofen for a few days (2 tablets / 4-6 hrs).									Y	10/15/2008	10/17/2008	2	None	PUB	UNK	Wellbutrin, Isoprinol, Birth Control Pills	None	Pre-Hypertension,Mild depression			1						1	Arthralgia	FLU3~SANOFI PASTEUR~U27688A~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329408	10/21/2008	MO	65.0	65		F	10/21/2008	swollen, hot, red 5 1/2 inches by 4 1/2 inches from injection site on 4th day from injection.  TREATMENT:  Benadryl and Mortin.									U	08/16/2008	08/17/2008	1		UNK	PUB		none	allergic to penicillin and related, sulfa, hydraclorathiazine			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0329409	10/21/2008	OH	5.0	5		M	10/21/2008	Developed rash from the waist down about 12-16 hours after receiving FluMist.  Also developed swelling in the feet and ankles the following day.  Child was having pain.				Y					U	09/27/2008	09/27/2008	0	Follow-up after ER visit to Dr.	UNK	UNK		None Reported	Unknown			1						1	Joint swelling; Oedema peripheral; Pain; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0329413	10/21/2008	NE	1.25	1	.3	F	10/21/2008	Left thigh erythema swelling heat, induration of 8cm in diameter.				Y					U	10/20/2008	10/21/2008	1		PVT	PVT		None	None			1						1	Erythema; Induration; Skin warm; Swelling	DTAP~SANOFI PASTEUR~C2956AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~~3~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~~1~~LL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~~4~~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0329414	10/21/2008	CO	7.0	7		F	10/21/2008	Pt was evaluated for possible reaction to Flu vaccine on 10-20-08 by Dr. His documentation: There is an area drawn around the original area of erythema which is 2x3 cm. Now redness extends to just above the elbow. Plan of care: I suspect this is cellulitis. Doubt local reaction but she did have immediate reaction (vomited and slept excessively). Will treat as cellulitis but report as adverse reaction. Per Dr.				Y					Y	10/18/2008	10/19/2008	1		UNK	UNK	Albuterol, Qvar	None	ASTHMA, INTERMITTENT   FHX CELIAC DISEASE   FAMILY HX OF VON WILLEBRAND DISEASE.   SHORT STATURE			1						1	Cellulitis; Erythema; Hypersomnia; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881291P~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0329416	10/21/2008	TX	60.0	60		M	10/21/2008	Reason for admission: Pt received flu shot 10-18-08 at approximately 0815; came to Emerg Dept on 10-18-08 at 1645 c/o itching and rash, was given diphenhydramine 50mg IM at 1758; returned to Emerg Dept 10-19-08 at 1038 w/complaints of rash all over body and blisters and whelps, was given methylprednisolone 125mg IM and hydroxyzine 50mg IM; Returned 10-20-08 to Emerg Dept w/complaints of CP mid/lt sternal on a scale of 8/10 along with lightheadedness and SOB; reports on admission that he is pain free but rash and blisters are returning. The Pt was admitted due to his hx of CAD, but it is felt he had an anxiety reaction to his continuing circumstances, as his chest pain resolved quickly upon admission without any actual treatment of the chest pain itself. Pt also received diphenhydramine 25 mg IV q 8 x 2, prednisone 20 mg q am and cetirizine 10 mg q am as an inpt.				Y	Y	2			Y	10/18/2008	10/18/2008	0		UNK	UNK	albuterol/ipratropium inhaler, atenolol, clopidogrel, etodolac XL, ezteimibe/simvastatin, lisinopril, omeprazole	None	Pre-existing medical conditions: CAD, HTN, hyperlipidemia, GERD, BPH anxiety, osteoarthritis, Meniere's disease			1						1	Anxiety; Blister; Chest pain; Condition aggravated; Dizziness; Dyspnoea; Pruritus; Rash; Rash generalised; Urticaria; Anxiety; Blister; Chest pain; Condition aggravated; Dizziness; Dyspnoea; Pruritus; Rash generalised; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA174AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA174AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Hospitalisation	Influenza
0329417	10/21/2008	WI	64.0	64		F	10/21/2008	Approx 2 hours after vaccine was administered I became very dizzy and sick to my stomache and vomited.  This lasted approx 24hours. Vaccine was administered on Monday October 6, 2008									Y	10/06/2008	10/06/2008	0		PUB	UNK						1						1	Dizziness; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U2809AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329418	10/21/2008	IL	47.0	47		F	10/21/2008	Pt. complained of fatigue on day of vaccine administration.  The next day, pt. had shortness of breath.  Pt. then began to develop pruritis on entire body and then developed hives on wrists, groin, waist, back, stomach.  Pt. had a reddened rash to face and chest.  Pt. called her MD on 10/17/2008.  Pt. was instructed by MD to take Benadryl and follow-up with an appointment for allergry testing.									Y	10/15/2008	10/15/2008	0	None.	UNK	PVT	Claritin D, Lipitor, L-Thyroxine	None.	Allergies to sulfa, Bactrim, iodine, seasonal and environmental allergies, sulfur based preservatives, hypothyroidism, hypercholesterolemia, post-breast cancer			1						1	Dyspnoea; Pruritus; Rash; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA187AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0329419	10/21/2008	PA	19.0	19		F	10/21/2008	Patient Recieved vaccines on 10/18/08 at a store flu clinic. On Monday the patient reported that her arm was red and sore to a pharmacy technician. I called her today to see get all of the details and see how she was doing. she said that her right arm from shoulder to elbow was red, sore, warm the touch, and swollen. she said that she has limited range of motion of her arm and that she can't put weight on it. I asked her if she had been to a physician yet and she said NO. She has taken tylenol for the pain but is unable to take an antihistamine because she is allergic to the class. I urged patient to see  physician because she said that it is progressively getting worse. Patient said she did not want to go to the ER because to expensive and I told her about the  urgent care across the street and they only charge an office visit copay. She said she will try to go there tomorrow.				Y					U	10/18/2008	10/19/2008	1		UNK	UNK	N/A	N/A	Allergies: Penicillin, Sulfonamides, Antihistamines, and DIPHENHYDRAMINE			1						1	Erythema; Injected limb mobility decreased; Oedema peripheral; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~U2806AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0870X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0329420	10/21/2008	KY	77.0	77		M	10/21/2008	The patient stated approximately 1-2 hours after getting the influenza vaccine at our office 10/20/08  8:45 a.m.  Soon after, he began to get hives in the bend of the right arm at the site of a venipuncture he had received earlier that morning. Then his groin, and thigh areas started whelping up with hives and itching along with his hands becoming red and swollen. He was still unable to wear his rings on either hand. No respiratory problems reported. He was seen 10/21/08 in our office for appointment regarding the above symptoms. Patient was given an injection of Kenalog 40mg/ml 1ml IM in his L Dorsogluteal area.  The patient tolerated this well. Patient also given prescription for Atarax 25mg 1 po tid prn itching.									U	10/20/2008	10/20/2008	0		PVT	PVT	Norpace 150mg 1 po bid  Asprin 325 mg i po qd  multivitamin daily, calcium+d 1 po bid Cardura 4mg 1/2 po qd  Naproxen sod 375mg po bid prn	none noted	not allergic to eggs NKMA			1						1	Erythema; Oedema peripheral; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2751AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329421	10/21/2008	WI	35.0	35		F	10/21/2008	Per patient the reaction started around 8pm. Ithching subsided around 11pm. Swelling was gone when patient awoke the next morning. Rash gone after next day.									Y	10/17/2008	10/17/2008	0		PUB	UNK		NONE KNOWN	PREGNANCY			1						1	Pruritus; Rash; Swelling	FLU3~SANOFI PASTEUR~U2809AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329422	10/21/2008	IL	4.0	4		M	10/21/2008	Patient had a high temperature for 4 days (101-104 degrees throughout the four days).  He also had had diarrhea.									Y	10/16/2008	10/16/2008	0		UNK	UNK		none	none			1						1	Body temperature increased; Diarrhoea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329423	10/21/2008	IL	11.0	11		M	10/21/2008	seiler had a high fever of 100- 103 degrees for 4 days. he also had severe diarea									Y	10/16/2008	10/17/2008	1		PVT	UNK		no	no			1						1	Diarrhoea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329424	10/21/2008	NY	50.0	50		F	10/21/2008	Within hours of the flu vaccine I developed a severe headache, burning, red, itchy, swollen eyes, tight feeling in lungs, all over ache.  *I do have problems with allergies, although this seemed worse than usual.   I also have asthma but had been fine all throughout the day.  My husband had been not feeling well over the weekend, as well.   I'm not sure if it was related to the vaccine, but when a friend told me she had a very simliar reaction after receiving the shot I thought I'd report it.									Y	10/20/2008	10/20/2008	0		UNK	UNK	Celexa, Zyrtec, Levoxyl, Estratest, Triamterene, vinpocetine		Allergies (seasonal) as well as unknown food allergies (possibly peanuts).   No  reaction to eggs.			1						1	Chest discomfort; Eye irritation; Eye pruritus; Eye swelling; Headache; Ocular hyperaemia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329426	10/21/2008	MO	57.0	56		M	10/21/2008	approx. 24 hours after vaccination was given, employee complained of skin hot to touch, red area, tenderness and swelling from site of injection (deltoid) to anitcubital space.  He would be interested to know what he possibly reacted to in the vaccine.  No reaction from the influenza vaccine given in the other arm.				Y					U	10/17/2008	10/18/2008	1	Saw private MD on 10/20/08, dx allergic reaction or infection.	UNK	PVT	Unknown	Unknown	Unknown			1						1	Hypersensitivity; Infection; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA177AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1161X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0329430	10/21/2008	MN	54.0	54		F	10/21/2008	minor hives, then swelling of airway, trouble swallowing and breathing, 911 was called - ER administered IV Benadryl STAT and then Prednisone orally and Zantac.  IV drip and observation for several hours.  Monitor of heart and several exams of airway and outside of throat. hives were about 3 hrs. after shot airway was about 6 hours after shot				Y					Y	10/15/2008	10/16/2008	1		UNK	UNK	synthroid, topomax, klonopin, low-dose aspirin, zantac, albuterol inhaler(as needed), tylenol					1						1	Dysphagia; Dyspnoea; Pharyngeal oedema; Urticaria; Throat tightness; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~2	USA	Emergency room visit	Influenza
0329431	10/21/2008	CA	37.0	37		M	10/21/2008	Patient had been previously diagnosed with Asthma in January 2008 after returning home from a 15-month deployment where asthma symptoms began. After about one month of treatment, all symptoms ceased and patient ceased to take any medication. Symptoms had been nonrecurrent since February 2008. Within 24 hours of Flumist administration, asthma symptoms returned in full force. Patient says symptoms are identical to the ones he had when they began in 2007.				Y					U	10/20/2008	10/20/2008	0		MIL	MIL		Previously diagnosed asthma, but without symptoms.	Asthma; surgery to remove fluid from two collapsed lungs following pneumonia in 1997, which resulted in scar tissue in the lungs			1						1	Asthma; Condition aggravated	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0329432	10/21/2008	CA	47.0	47		F	10/21/2008	Several hours after flu shot, began to have severe coughing and itching, rash.  Then tongue became swollen.  Went to doctor who ordered antihistamine, aderol, flonaise, prednisone.  Several hours later had chills, fever of 100.7 and nausea.  Next day symptoms improved but also had swelling under eyes causing dark circles and itchiness.									Y	10/20/2008	10/20/2008	0		UNK	PVT		none	hypothyroidism			1						1	Chills; Cough; Dark circles under eyes; Eye pruritus; Eye swelling; Nausea; Pyrexia; Rash pruritic; Swollen tongue	FLU3~SANOFI PASTEUR~U2764AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329434	10/21/2008	AZ		61		U	10/21/2008	Patient returns to clinic 10/21/2008 reports that shortly after influenza vaccine on 10/19/2008 had fever, swelling of face and shaking with the fever and shaking stopping and that the swelling of the face remains and sore throat - very scant swelling of bilateral eyebrow area - airway open- no respiratory distress - throat without redness, swelling, odor, exudate or post nasal drip and without visable tonsils. Cervical lymph chain without lymphadenopathy or tenderness to palpation. Referred to urgent care with instructions of need to be seen tonight and to list influenza vaccine as allergy with patient verbalizing understanding to all instruction				Y					Y	10/19/2008	10/19/2008	0	None available - patient referred to Urgent Care	UNK	PVT	Avandamet, Simvstatin, lisinopril	patient reported on vaccine administration form no current moderate or severe illnesses at time of vaccination	no known allergies			1						1	Oropharyngeal pain; Pyrexia; Swelling face; Tremor	FLU3~SANOFI PASTEUR~u2809aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329437	10/21/2008	CA	2.0	2	.6	M	10/06/2008	A serious, post-marketed study report of intussusception and viral syndrome was received from a study investigator concerning a 31-month-old male (PID 27395430), who is enrolled in the MI-MA162 study. On the day of FLUMIST vaccination, cough and nasal congestion x two weeks-resolving and eczema on the toe and finger were noted. No concomitant medications have been reported. The subject received FLUMIST on 08-Jan-2008. On the same day of receipt of FLUMIST, the subject complained of abdominal pain. The subject was seen at a clinic and abdominal pain was assessed as benign and possible constipation. There was no report of fever, vomiting or diarrhea. The following day the subject was seen in the emergency room due to persistent vomiting. Intravenous hydration was done, subject became stable and was discharged home. On 10-Jan-2008, the subject was seen back in the emergency room due to persistent abdominal pain and vomiting green color fluid and was subsequently admitted to the hospital. The subject pointed to his right side as the site of abdominal pain and stated having the pain every 30-45 minutes. The subject's weight was noted to have gone down from 35lbs on 08-Jan-2008 to 33 lbs on 10-Jan-2008. At the time of exam, the abdomen was noted to be soft with decreased bowel sounds and mid-right side palpable mass. A KUB (kidney, ureter, bladder) xray showed opacification on the right mid area consistent with intussusception. Other laboratory findings included white blood count = 15.7; hgb = 13.6; platelet count = 469; neutrophils = 80; lymphocytes = 17; urine ketones = 40; bilirubin, total = 0.1 and aspartate aminotransferase = 68. The subject underwent an attempted reduction by barium enema but was unable to reduce the intussusception. The subject was then transferred to the operating room and underwent surgical reduction of intussusception without bowel resection. Following operative reduction of his intussusception, the subject developed a short episode of post-operative pain and low grade fever of 101.9 degrees Fahrenheit which was felt to be consistent with a viral prodrome and as such resolved spontaneously without antibiotics or further invasive therapy. The subject made a generally uncomplicated recovery and was discharged on 13-Jan-2008. The events were considered resolved on 15-Jan-2008. The study investigator assessed the severity of the events as moderate and provided a causality assessment of possibly related for the events of intussusception and viral syndrome. Follow-up information received on 27-Aug-2009 clarified the onset date of the events to meet serious criteria as 10-Jan-2008.					Y				Y	01/08/2008	01/08/2008	0	AST, 01/10/08, 68; Barium Enema, 01/10/08, NI; Bilirubin total, 01/10/08, 0.1; Hgb, 01/10/08, 13.6; Ketones UA, 01/10/08, 40; KUB, 01/10/08, opacification rt. mid area c/w intussusception; Lymphocytes % automated count, 01/10/08, 17; Neutrophils % automated count, 01/10/08, 80; Platelets count, 01/10/08, 469; WBC count, 01/10/08, 15.7	PVT	OTH	Concomitant drug(s) not reported		On the day of FLUMIST vaccination, cough and nasal congestion x two weeks-resolving and eczema on the toe and finger were noted.		MEDI0007265	1						1	Abdominal mass; Abdominal pain; Aspartate aminotransferase increased; Barium enema; Blood bilirubin normal; Diarrhoea; Enema administration; Gastrointestinal sounds abnormal; Haemoglobin normal; Intussusception; Lymphocyte count; Neutrophil percentage increased; Platelet count increased; Pyrexia; Surgery; Urinary system X-ray; Urine ketone body present; Viral infection; Vomiting; Weight decreased; White blood cell count increased	FLUN3~MEDIMMUNE VACCINES, INC.~500500P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0329438	10/21/2008	CA	4.0	4		M	10/06/2008	A serious event of pneumonia was reported by a Study Investigator concerning a four-year-old male subject (Pat ID# 42458400) enrolled in a post-marketed study MI-MA162.  Medical history included cough and congestion with intermittent fever for three weeks.  Concomitant vaccinations included DTaP, IPV, MMR and Hep A and were received on the same day FLUMIST was received.  The subject received FLUMIST on 29-Nov-2007.  The subject had been feeling better for a few days after his vaccinations on 29-Nov-2007, he then developed a fever of 104 degrees Fahrenheit, was vomiting and taking only sips of fluid.  On 04-Dec-2007 the subject was seen by his primary physician and diagnosed with pneumonia after a chest x-ray showed a right middle lobe infiltrate.  He was prescribed amoxicillin and sent home.  The subject's condition did not improve with continued cough, occasional post-tussive emesis, fever and worsened breathing.  He was admitted to the hospital on 06-Dec-2007 with a oxygen saturation of 91% on room air and a respiratory rate of 55.  The subject was treated with intravenous fluids, ceftriaxone, albuterol nebulizers and supplemental oxygen.  A NP swab done 05-Dec-2007 was positive for RSV. On 08-Dec-2007 the subject was discharged from the hospital and per the father he was reported as doing fine with an occasional cough.  The pneumonia was considered resolved on 08-Dec-2007.  No additional doses of FLUMIST were received.  The Study Investigator considered the event of pneumonia as possibly related to study drug.					Y	2			Y	11/29/2007	12/04/2007	5	4-Dec-2007, Chest x-ray, right middle lobe infiltrate; 05-Dec-2007, NP swab, RSV positive; lymphocyte count, 12/06/07, 12%; Neutrophils, 12/06/07, 83%; White blood cell count, 12/06/07, 13.9	PVT	OTH	Concomitant Drug(s) Not Reported		cough and congestion with intermittent fever for 3 weeks		MEDI0007264	1						1	Chest X-ray abnormal; Condition aggravated; Cough; Dyspnoea; Fluid intake reduced; Lung infiltration; Lymphocyte percentage decreased; Neutrophil percentage increased; Oxygen saturation decreased; Pneumonia; Post-tussive vomiting; Pyrexia; Respiratory rate increased; Respiratory syncytial virus serology positive; Vomiting; White blood cell count increased	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B056DA~UNK~UN~UN~DTAP (INFANRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500496P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~MERCK & CO. INC.~0304U~UNK~UN~UN~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~Z0548~UNK~UN~UN~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1228U~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Hospitalisation	Influenza
0329439	10/21/2008	CA	3.0	3		M	10/06/2008	A serious event of respiratory distress syndrome was reported by a Study Investigator concerning a 39-month-old male subject (Pat ID# 42455284) enrolled in a post-marketed study MI-MA 162.  Medical history included adenotonsillar hypertrophy, obstructive sleep apnea, heavy snoring since birth and worsening gasping and choking with apneic pauses.  The patient's parents both smoke.  No concomitant medications were reported.  The subject received FLUMIST on 15-Oct-2007.  The subject was scheduled for a tonsil and adenoidectomy due to known adenotonsillar hypertrophy and obstructive sleep apnea.  On 18-Oct-2007 the subject developed symptoms of respiratory distress syndrome.  On 21-Oct-2007 the subject was seen in the emergency room for respiratory difficulty after he became pale and blue.  The subject underwent a tonsillectomy and adenoidectomy, after surgery the subject was intubated and a chest x-ray on 22-Oct-2007 showed bronchial thickening, question of mild segmental area of atelectasis or infiltrate in the right base.  On 22-Oct-2007 the subject was extubated and discharged to home on 23-Oct-2007.  The subject did not receive any further doses of FLUMIST.  The Study Investigator considered the event of respiratory distress syndrome as possibly related to study drug.					Y	2			Y	10/15/2007	10/18/2007	3	21-Oct-2007, Chest X-ray, Bronchial thickening; 21-Oct-2007, Tonsil tissue, lymphoid follicular hyperplasia; 22-Oct-2007, Chest X-ray, Bronchial thickening and new area of segmental atelectasis or infiltrate in the right base	OTH	OTH	Concomitant Drug(s) Not Reported	Obstructive sleep apnea syndrome	Since birth heavy snoring; worsening gasping and choking with apneic pauses; adenotonsillar hypertrophy		MEDI0007263	1						1	Acute respiratory distress syndrome; Adenoidectomy; Bronchial wall thickening; Chest X-ray abnormal; Cyanosis; Dyspnoea; Endotracheal intubation; Lymphoid tissue hyperplasia; Pallor; Tonsillectomy	FLUN3~MEDIMMUNE VACCINES, INC.~500486P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0329441	10/21/2008	OH	41.0	41		F	10/08/2008	A serious spontaneous report of Sjogren's syndrome tingling, twitching, tightness in calves, shaky and weakness, has been received from a registered nurse concerning a 40-year-old female patient, subsequent to FLUMIST. The patient's past medical history includes dry mouth for two years. The patient's WBC (white blood cell ) count was reportedly low in 2007 so the patient had injectable vaccine; no further information was provided. The patient also had three new tooth cavities. The patient has not been taking any prior medication. The patient received FLUMIST on 09-Sep-2008. The patient began having tingling in the thighs, twitching, and tightness in calves (making it difficult to walk) on 03-Oct-2008. Two weeks prior to these events, the patient has been experiencing tingling (felt like asleep) at the tip of the nose. The patient's symptoms progressed over the weekend and by 08-Oct-2008, symptoms in the arms described as weak and shaky, and abdomen and diaphragm twitching were reported. The patient was evaluated in the physician's office and in the emergency room on an unknown date. The patient was not admitted to the hospital. The patient had laboratory tests and an MRI of the brain. On 09-Oct-2008, the patient was informed by the rheumatologist of a diagnosis of Sjogren's syndrome due to elevated SSA (Sjogren's syndrome antibodies) and RA (rheumatoid arthritis) antibodies. The patient's EMG (electromyography) was reportedly OK. The patient was prescribed baclofen, metaxalone, clonidine and prednisone. The patient will also be placed on hydroxychloroquine. The patient was feeling better after treatment. The reporter causality assessment for the event of Sjogren's syndrome was not related to FLUMIST. The reporter further stated that in retrospect, the patient had symptoms for quite a while. According to the reporter, the physician felt that the event was not related to FLUMIST.									U	09/09/2008			Elevated SSA (Sjogren Syndrome antibodies) and RA (rheumatoid arthritis antibodies; EMG: ok; 2008: WBC ok; MRI of the brain: Result not reported	OTH	OTH	Concomitant drug(s) not reported	Dry mouth; tooth cavity	2007: WBC (white blood cell) count low; No prior medication.		MEDI0007226	1						1	Antibody test positive; Asthenia; Electromyogram normal; Gait disturbance; Muscle tightness; Muscle twitching; Nuclear magnetic resonance imaging brain; Paraesthesia; Rheumatoid factor increased; Sjogren's syndrome; Tremor; White blood cell count normal	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0329442	10/21/2008	TX	42.0			F	10/01/2008	A serious spontaneous report of stuttering, aphasia, paresthesia, feeling that all her extremities were paralyzed, falling to the ground and not cognizant of what happened was received from a physician concerning a 42-year-old female subsequent to FLUMIST. The patient has migraine. She has no hypertension, diabetes or history of transient ischemic attack (TIA). Her past medical history included seizure twelve years ago after she bumped her head. At that time, she was on birth control pills. The patient was never diagnosed with epilepsy nor was she given maintenance anti-convulsant drugs. For the past two weeks prior to FLUMIST vaccination on 24-Sep-2008, the patient has been experiencing intermittent episodes of feeling funny and intense headache. The patient is on a lot of unreported medications for unknown indications. The patient received FLUMIST for the first time on 24-Sep-2008. The patient reported feeling funny and experiencing intense headache prior to FLUMIST vaccination on 24-Sep-2008. After receiving FLUMIST, the patient went home. While at home and about 30-45 minutes after FLUMIST administration, she began to experience stuttering, aphasia and paresthesia. She also felt that all her extremities were paralyzed, fell to the ground and was not cognizant of what happened. It was not reported whether she had a black-out. The patient was brought by her friends to the local emergency room. At the emergency room, no focal defects were noted. A head CT scan was performed which showed no abnormality. It was determined that there was no evidence of stroke or intracranial bleed. Since FLUMIST administration, the patient's stuttering, aphasia, and paresthesia have occurred intermittently. The patient's stuttering and aphasia would come and go. The paresthesia affected her extremities alternately at various sites. The symptoms of stuttering, aphasia, and paresthesia did get better. The patient was seen in the physician's clinic on 01-Oct-2008. Her physical and neurologic examination did not reveal any abnormality except that the patient would stutter followed by inability to finish a sentence. Her physician could not be certain if she had true aphasia or whether she could not just find the words to say. Head MRI was done on the same day and was normal. A neurology consult was being considered but no appointment was scheduled. As of 01-Oct-2008, the patient's stuttering, aphasia, and paresthesia have worsened. The adverse events of feeling all her extremities were paralyzed, Falling to the ground and not cognizant of what happened resolved on 24-Sep-2008.									N	09/24/2008	09/24/2008	0	CT scan, 09/24/08, normal head scan; MRI, 10/01/08, normal head MRI	OTH	OTH	Concomitant drug(s) not reported	Migraine	She has been experiencing intermittent episodes of feeling funny and intense headache for the past two weeks prior to FLUMIST vaccination on 24-Sep-2008; She has no hypertension, diabetes or history of transient ischemic attack (TIA); Her past medical history included seizure twelve years ago after she bumped her head while on birth control pills but was never diagnosed with epilepsy nor was she given maintenance anti-convulsant drugs; No previous vaccination with FLUMIST.		MEDI0007167	1						1	Altered state of consciousness; Aphasia; Computerised tomogram normal; Dysphemia; Fall; Neurological examination normal; Nuclear magnetic resonance imaging normal; Paraesthesia; Paralysis	FLUN3~MEDIMMUNE VACCINES, INC.~500543P~1~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0329443	10/21/2008	CA	45.0	45		F	10/21/2008	This case was reported by a pharmacist and described the occurrence of migraine in a 45-year-old female subject (also a pharmacist) who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included MOTRIN. On 8 October 2008 at 11:30 the subject received a dose of FLULAVAL at 0.5 ml in the right arm. On 8 October 2008, approximately 40 to 60 minutes after vaccination with FLULAVAL, the subject experienced migraine, fatigue and tiredness. The pharmacist considered the events were disabling. At the time of reporting the outcome of the events was unspecified.								Y	U	10/08/2008	10/08/2008	0	UNK	OTH	OTH	Ibuprofen	Unknown	The subject has no relevant medical history. She has received flu shots previously with no reactions.		A0752675A	1						1	Fatigue; Migraine	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~1~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Disabling	Influenza
0329444	10/21/2008	CA	29.0			F	10/21/2008	This case was reported by a pharmacist and described the occurrence of migraine in a 29-year-old female subject (a pharmacy technician) who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included paroxetine. On 8 October 2008 at 11:30 the subject received a dose of FLULAVAL at 0.5 ml in the right arm. On 8 October 2008, approximately 40 to 60 minutes after vaccination with FLULAVAL, the subject experienced migraine, nausea and vomiting. The subject was hospitalized and the pharmacist considered the events were disabling. The subject was treated with ADVIL for migraine. At the time of reporting the outcome of the events was unspecified.					Y	0		Y	U	10/08/2008	10/08/2008	0	UNK	OTH	OTH	Paroxetine hydrochloride	Unknown	The subject has received flu shots previously with no reactions.		A0752681A	1						1	Migraine; Nausea; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~1~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation,Disabling	Influenza
0329445	10/21/2008	FL	41.0	41		F	10/21/2008	This case was reported by a physician and described the occurrence of Guillain Barre Syndrome in a 41-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline) for prophylaxis. Concurrent medications included Xanax (0.25 mg, three times daily as needed). Ativan (1 mg at bedtime as needed), atenolol, Glucophage and Lotrel (5/20 mg once daily). Concurrent medical conditions included autosome dominant polycystic kidney disease with early stage renal disease and new onset diabetes. On 26 September 2008 at 09:52 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. On the morning of 06 October 2008, the subject presented to the physician's office with numbness and tingling in the upper left limb that had started that morning. The subject was hospitalized on 08 October 2008 or 09 October 2008 and was paralysed including facial muscles, upper and lower limbs and respiratory muscles. The subject was on a ventilator and was unconscious. The physician stated at the time of reporting that at this point they were unsure if the subject was unconscious due to the events or due to medication she is being treated with due to having the ventilator in place. Guillain Barre Syndrome was reported. the subject was treated with intravenous immunoglobulin (dates of treatment thought to be 08 October 2008 through 10 October 2008), but the subject didn't have much response. The physician considered the events were disabling, life threatening and clinically significant or requiring intervention. In the reporter's opinion, the events were possibly related to treatment with FLULAVAL.			Y	Y	Y	0		Y	U	09/26/2008	10/01/2008	5	Unk	PVT	PVT	Alprazolam, Lorazepam, Atenolol, Metformin hydrochloride, Lotrel, Amlodipine + Benazepril hydrochloride)	Unknown	The subject has autosome dominant polycystic kidney disease with early stage renal disease and new onset diabetes.		A0752682A	1						1	Blood product transfusion; Diplegia; Facial palsy; Guillain-Barre syndrome; Hypoaesthesia; Loss of consciousness; Mechanical ventilation; Monoplegia; Paraesthesia; Paralysis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0329451	10/21/2008	MI	85.0	85		F	10/20/2008	Patient developed warmth, redness and swelling of entire RUE to elbow and shoulder. Started about 1-2 hrs after injection. 10/22/08-records received for DOS 10/17-10/18/08-DC DX: Right upper arm erythema, swelling and pain. Admitted with right painful upper right arm. Arm became erythematous, swollen, warm and tender, rash and pain.				Y	Y	1			Y	10/17/2008	10/17/2008	0	None 10/22/08-records received-MRI shoulder rotator cuff tear, moderate joint effusion.	PVT	PVT		None	None 10/22/08-records received-PMH:osteoporosis.			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA169AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0867X~2~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0329452	10/21/2008	AZ	16.0	16		F	10/20/2008	Syncopal episode following administration of HPV# 1 vaccine									Y	10/20/2008	10/20/2008	0		PVT	PVT		None	None			1						1	Syncope	FLUX~UNKNOWN MANUFACTURER~112005AA~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~0560X~1~ID~UN~HPV (GARDASIL)~1	USA		Influenza
0329454	10/21/2008	VA	59.0	59		F	10/21/2008	Received vaccines (Flu and Pneumovax) 10/15/08. 10/16/08 Woke up with extreme lower back pain and joint pain. Also started with fever 103 F that day. Sick all day 10/16/08. 10/17/08 - Still had fever 99-100, nausea, clammy, joint pain. (L) arm local reaction. Red/hot/tender 3x5 inches. 10/18/08 Woke up with no problems - back to normal.									Y	10/15/2008	10/16/2008	1	None	PUB	OTH	None	None noted	Fibromyalgia; Allergy to Latex			1						1	Arthralgia; Back pain; Cold sweat; Erythema; Local reaction; Nausea; Pyrexia; Skin warm; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89685~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0962U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329456	10/21/2008	CA	45.0	45		F	10/21/2008	Patient reports achiness, weakness, dizziness, rapid heart rate, chills and shallow breathing 4 1/2 hrs after receiving flu shot. 22 hours after shot symptoms improving, but not gone.									Y	10/20/2008	10/20/2008	0		PUB	PUB		None	Cirrhosis of live; Hepatic Encephalopathy, Hypothyroidism			1						1	Asthenia; Chills; Dizziness; Heart rate increased; Hypoventilation; Pain	FLU3~SANOFI PASTEUR~U2807AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329457	10/21/2008	AZ	78.0	78		F	10/21/2008	Chills, rigors, weakness x 2 days.									Y	10/14/2008	10/15/2008	1	None	PVT	UNK		None	None			1						1	Asthenia; Chills	FLU3~SANOFI PASTEUR~U2751AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329458	10/21/2008	OH	63.0	63		M	10/13/2008	No adverse effects noticed.  Patient given Prevnar instead of Pneumovax, accidentally given by fill in nurse helping that morning.									Y	10/08/2008				PVT	PVT	Norvasc; Dyazide; ASA; KC1	None	HTN; Hyperlipidemia; Obesity			1						1	Wrong drug administered	FLU3~SANOFI PASTEUR~U2754AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C80901~UNK~IM~LA~PNEUMO (PREVNAR)~1	USA		Influenza
0329460	10/21/2008	OH	64.0	64		M	10/13/2008	No adverse effects noted. Pt. given PREVNAR instead of PNEUMOVAX accidently given by fill-in nurse helping that morning									Y	10/08/2008				PVT	PVT	PROTONIX; COZAAR; ATENOLOL; ASA; CARDURA; MAXIDE; lovastatin; PLENDIL; CELEXA; KCl; METFORMIN	None	HTN; GERD; NIDDM: Anxiety			1						1	Wrong drug administered	FLU3~SANOFI PASTEUR~U2754AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C80901~UNK~IM~LA~PNEUMO (PREVNAR)~1	USA		Influenza
0329461	10/21/2008	OH	56.0	56		F	10/13/2008	No adverse effect noted; Patient given PREVNAR instead of PNEUMOVAX accidentally given by fill-in nurse helping that morning									Y	10/08/2008				PVT	PVT	ASA, Relpan,COZAAR , EFFEXOR, Januvia Amaryl, Omacur Byetta	None	HTN, NIDDM, hypertriglyceremia, Depression			1						1	Wrong drug administered	FLU3~SANOFI PASTEUR~U2754AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C80901~UNK~IM~LA~PNEUMO (PREVNAR)~1	USA		Influenza
0329462	10/21/2008	FL	57.0	57		F	10/20/2008	Employee states that she received vaccine at 4PM.  That evening around 7PM, she was in a drug store.  Her throat started closing, chest started filling up.  Face got hot.  Vaccinated arm, head and eyes were hurting.  Pharmacist told her to take Benadryl and she did.									Y	10/15/2008	10/15/2008	0	None done.  Patient did not seek medical help other than pharmacist.	PUB	PVT	Calcium; Ecchanesia; Centrum; Pomegranite	No	Asthma; Sinusitis			1						1	Chest discomfort; Eye pain; Flushing; Headache; Pain in extremity; Throat tightness	FLU3~SANOFI PASTEUR~U2832AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329465	10/21/2008	KS	6.0	6		M	10/21/2008	Administered vaccines and when patient stood up he became pale and c/o not feeling well.  Told patient to lay down on exam bed and gave apple juice, took vital signs - BP 96/58, P 77, Sat 98%.									Y	10/21/2008	10/21/2008	0		PVT	PUB						1						1	Malaise; Pallor	FLUN3~MEDIMMUNE VACCINES, INC.~50056OP~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB260AA~1~UN~LA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1146X~2~UN~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0329466	10/21/2008	CO	30.0	30		M	10/21/2008	Employee was given vaccination 10 am began feeling lightheaded,dizzy and nausea 30 minutes after, then vomited x3 over next 30 min, denied ever having headache, chest pain, difficulty breathing, abdominal pain, swelling, redness or hives.  Employee left work for the day, contacted at home 2 hours later still feeling weak and dizzy.									U	10/20/2008	10/20/2008	0		OTH	OTH	None	None Asymptomatic	None			1						1	Asthenia; Dizziness; Nausea; Vomiting; Activities of daily living impaired; Asthenia; Dizziness; Nausea; Vomiting	FLU3~CSL LIMITED~03549111A~1~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|FLU3~CSL LIMITED~0354911A~1~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~2	USA		Influenza
0329468	10/21/2008	IL	72.0	72		F	10/21/2008	2 days after shot patient presented, complaining of swelling, redness, pain.  Doctor prescribed Levaquin 500mg once qd x 10 days, thought it might be Phlebitis.				Y					U	10/15/2008	10/17/2008	2		OTH	PUB	Unknown					1						1	Erythema; Pain; Phlebitis; Swelling	FLU3~CSL LIMITED~01049211A~UNK~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~0619X~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0329469	10/21/2008	FL	28.0	28		F	10/21/2008	Within 15 minutes of vaccine - vertigo, cold sweats, chills.  After 30 minutes came to pharmacy.  Given 25mg Benadryl.  After 45 minutes emesis x 2.  Stayed with patient til husband picked her up from work.  Would not allow us to call 911 - no insurance.									Y	10/20/2008	10/20/2008	0	BP 127/69, P 86	OTH	UNK						1						1	Chills; Cold sweat; Vertigo; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA157AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0329470	10/21/2008	AR	80.0	80		F	10/21/2008	pt got up to go to bathroom early am, did not feel well and felt weak and dizzy.  She sat and vomited and felt faint- called for help and husband found her on floor- he call 911.  The ambulance took her to BRMC ER where she was Tx Dx and release				Y					Y	10/15/2008	10/16/2008	1	CT head negative;  Glucose,156;  BUN, 14;  Electrolytes, normal;  UA,3WBC	PVT	OTH	Takes ZOCOV;  EVISTA					1						1	Asthenia; Blood electrolytes normal; Blood glucose increased; Blood urea normal; Computerised tomogram normal; Dizziness; Malaise; Urine analysis normal; Vomiting	FLU3~SANOFI PASTEUR~U2739AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329472	10/21/2008	OH	27.0	27		M	10/21/2008	11:45am: Patient feels faint and dizzy, pulse 70 regular, strong: pale, BP 98/62: patient sitting with head down.  12:00 noon: called 911 c/o tightness in neck, pale.  12:03pm: EPI 0.2 cc: assisted to another room.  12:08pm: scared, pulse 80 regular strong: skin dry: BP 110/68: color improving.  12:10pm: Life squad on scene, pulse 80: always verbal: color improving: wife called.  12:15pm: Transported to hospital.				Y					U	10/16/2008	10/16/2008	0		OTH	PVT	Unknown	None				1						1	Dizziness; Dry skin; Fear; Muscle tightness; Pallor	FLU3~SANOFI PASTEUR~U2809AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329473	10/21/2008	MN	79.0	79		F	10/21/2008	had vaccine at 0140,  went home had supper.  At 0515 started with the chills & shaking.  Shaking continued with full body involvement.  No temp.  No diaphoresis. Went to bed.   Vomited x1.  Slept for a while-  next arm felt weak all over legs ached.									Y	10/15/2008	10/20/2008	5		PUB	PUB	Unknown	Unknown	Unknown			1						1	Asthenia; Chills; Pain in extremity; Tremor; Vomiting	FLU3~SANOFI PASTEUR~U2765AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329474	10/21/2008	CO	47.0	47		F	10/20/2008	Left shoulder soreness worsening over 7 days after vaccine with severe pain starting at night.  Day 7 left brachial neuritis.  RX Medrol dose pak.  RX Amitriptylizine.  RX Vicodisine.				Y					N	10/07/2008	10/14/2008	7	None	PVT	PVT		None	None			1						1	Musculoskeletal pain; Radiculitis brachial	FLU3~SANOFI PASTEUR~U2747AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329476	10/21/2008	CA	51.0	51		F	10/17/2008	Patient noted to develop complaints of chest and neck tightness approximately 5-6 minutes after flu shot, no known prior flu shot reactions, had associated tach apnea and respiratory distress, required albuterol 120 b x 2 with eventual improvement in symptoms, increase pulse flow from 150 to 370, 98% 02 Sat, negative EKG.				Y					Y	10/17/2008	10/17/2008	0	Respiratory distress s/p influenza vaccine; history of asthma; history of hypertension.	MIL	MIL			Respiratory distress s/p influenza vaccine; history of asthma; history of hypertension.			1						1	Chest discomfort; Immediate post-injection reaction; Muscle tightness; Respiratory distress; Tachypnoea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0329477	10/21/2008	NY	50.0	50		F	10/21/2008	Very dry eyes - developed watery eyes of a puss like fluid that made eyes stick - enlarged throat.  Heaviness in chest with congestion.  Face swelling and puffiness with red eyes by morning.  Still have puffy face and red eyes.										10/20/2008	10/20/2008	0		OTH	UNK		Yes - a couple hours later	No			1						1	Chest discomfort; Dry eye; Eye discharge; Ocular hyperaemia; Pharyngeal oedema; Respiratory tract congestion; Swelling face	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329482	10/21/2008	OH	43.0	53		F	11/21/2008	I received a call from pt, dob:5/14/55 on Thursday 10/16/08 at 1 pm, regarding an adverse reaction that occurred to her following an influenza vaccine injection on Monday 10/13/08 between 10:30 and 11:30 am. . The nurse on-site, had administered the vaccine between the hours of 10:30 and 11:30 and had left the clinic shortly after 11:30. Pt reported that she ate her lunch, at 11 am, it consisted of yogurt and fried chicken that she had brought with her from home that morning. Pt reported that at approximately 1 pm she became violently ill with vomiting, diarrhea, chills and shaking. She reported that she spiked a temp of 103 degrees farenheit. She reported 4 episodes of vomiting that continued into the evening. she remained at work until 4:30 pm at which time an associate offered to drive her home. She refused the offer and states I drove herself home with much difficulty. She stated that she had dark circles under her eyes the following morning from dehydration. On Thursday at the time of report, she was feeling much better. She was offered an appointment with a physician. Pt refused the appointment. She reports that her family physician and Neurologist in the office where she is employed stated that she should not have received the flu shot due to recent illness. Pt stated that she was on her final day of antibiotics following an episode of pneumonia. She states that she reported the recent illness to the nurse administering the vaccine and was told by that nurse there was no problem with having the vaccine administered at that time. Pt completed and signed a standard on-site vaccine consent form prior to receiving the vaccine. Sanofi/Avenis vaccine lot #U2807AA. Please add an additional page if necessary.				Y					Y	10/13/2008	10/13/2008	0	Unknown	OTH	PVT	Unknown	Last day of antibiotics	Unknown			1						1	Body temperature increased; Chills; Dark circles under eyes; Dehydration; Diarrhoea; Malaise; Tremor; Vomiting	FLU3~SANOFI PASTEUR~U2807AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329488	10/21/2008	FL	2.0	2	.0	F	10/21/2008	Patient had high fever to 104 within 24 hrs of the Flu Shot				Y					Y	09/30/2008	10/01/2008	1	Throat culture - Negative	PVT	PVT	None	None				1						1	Culture throat negative; Pyrexia	FLU3~SANOFI PASTEUR~UT27866A~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329489	10/21/2008	KS	8.0	8		M	10/20/2008	While pushing FLUMIST in the 2nd nostril, child jerked head backwards and said some got in my eye - it hurts. Called Medimmune - flushed child's eye with sterile water 5 min. later.									Y	10/17/2008	10/17/2008	0	None	PVT	OTH	ZYRTEC 10 mg daily; TYLENOL PRN	None	Seasonal allergies			1						1	Accidental exposure; Eye pain	FLUN3~MEDIMMUNE VACCINES, INC.~500560P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0329495	10/21/2008	OH	39.0	39		F	10/21/2008	A Patient that received an on-site flu shot on 10/14/08 between 9am and 10am at the Clinic called 10/20/08 to report an adverse reaction to the flu vaccine that was administered that morning by Clinic Nurse. Patient reported that she received her flu shot at approximately 9:15am that morning. Two hours post vaccination she started with a dry cough, tightness in her chest and throat, headache, malaise and general flu like symptoms. At that time she took at ALAVERT tablet. She ate her lunch which she brought from home despite feeling ill. She states that she continued to experience tightness in her throat, became flushed and pale and vomited. At that time, she was taken to the hospital by squad. At the hospital she was treated for an allergic reaction and given STEROIDS, BENADRYL, PHENERGAN and IV fluids. Labs were drawn. The patient ha no lab results to report. She then stated that she was feeling achy and was administered TORADOL. She was discharged to home at 5:30pm at which time she was extremely groggy. At home she was unable to sleep and experienced twitching in her lower limbs. She took ADVIL PM and states that she fell asleep between 3 and 4am. She complained of feeling congested and disorinte and had a sore throat the following day. She remained off work on Wednesday 10/15 and 10/16 and returned to work on Friday 10/17. She reported that she is feeling much better today, 10/20/08. Flu vaccine - Sanofi Aventis Lot #U2767AA				Y					Y	10/14/2008	10/14/2008	0	Unknown	OTH	PVT	Unknown	None	Unknown			1						1	Chest discomfort; Cough; Disorientation; Flushing; Headache; Hypersensitivity; Influenza like illness; Insomnia; Malaise; Muscle twitching; Oropharyngeal pain; Pain; Pallor; Respiratory tract congestion; Somnolence; Throat tightness; Vomiting	FLU3~SANOFI PASTEUR~U2767AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329496	10/21/2008	CA	34.0	34		F	10/20/2008	On 10/2/08 client received her 1st flu shot.  30-45 min after shot, felt a sensation at injection site & then began coughing with phlegm production. Unable to stop coughing.  Took Claritin, resolved X 1 hr, cough came back w/some difficult breathing.  Allergist & PCP sent her to ER where she was given IV Benadryl coughing & phlegm stopped.  Went home, coughing began again at 9 pm that night, took Claritin.  Coughing began again in the am, took Benadryl and Pepcid Q 6 hours though the weekend.  Monday morning took Claritin, ok until 3 pm, then had difficulty breathing, increased HR, faintness, took Claritin & Pepcid, still felt dizzy/faint -30 min later- PCP & Allergist again sent her to urgent care.  Finally allergist advised regular dosage of Claritin or Zyrtec.  Has been ok X 2-3 days at time of this report.  10/13/2008				Y					Y	10/02/2008				PUB	PUB	Claritin; Pepcid	None	Allergic to wine/sulfites		405778329496	1						1	Cough; Dizziness; Dyspnoea; Heart rate increased; Increased upper airway secretion; Injection site reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88635~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0329497	10/21/2008	AZ	44.0	44		M	10/21/2008	2:25 pm onset of dizziness.  Shaking to arms/hands, arms itching, lower lips tingling, blurred vision off/on with off/on approximately 2:55 pm.  3:14 pm vomits small amt whitish tan emesis.  Denied any other sx other than dizziness.  2:55 pm BP 149/79, Pulse 73.  3:05 pm BP 127/57, 55, 3:14 pm BP 121/77, P 75.  3:28 pm 127/75, P 71, sitting 113/51, P 64, standing 127/75, P 87.				Y					U	10/21/2008	10/21/2008	0	Sent to contracted provider our eval. refused EMS eval or to stay in center until s/s resolved.	OTH	PVT	Advil 10/20/08; Vicodin last week	Denies	Growth esophagus as a newborn appendectomy 85, bladder cancer 2002; 3 mammograms, treated with oral cancer treatment in 2006.			1						1	Dizziness; Paraesthesia oral; Pruritus; Tremor; Vision blurred; Vomiting	FLU3~CSL LIMITED~03549111A~2~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0329498	10/21/2008	TX	64.0	64		M	10/21/2008	Received PNEUMOVAX, PPV23 left deltoid on 10-15-2008; subjective report of temperature 102, dyspnea, swelling around left deltoid, pain physician recommended. topical application of warm compresses on 10-16-08; patient returned to clinic 10-17-08 received RX for Doxycycline.				Y					U	10/15/2008	10/15/2008	0	None	OTH	OTH		None	Allergies - niacin- rheumatoid arthritis; actinic, keratosis, disorder of bursae and tendons in shoulder, Amblyopia, degenerative disk disease,			1						1	Dyspnoea; Oedema peripheral; Pain in extremity; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88113~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0870X~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0329499	10/21/2008	MA	83.0	83		F	10/18/2008	Bruise on deltoid where vaccine given about 1 3/4 inches in diameter.									Y	10/14/2008				OTH	UNK						1						1	Injection site haematoma	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0329500	10/21/2008	CA	47.0	47		F	10/21/2008	(R) arm bruise, pain. Bilat leg, (R) arm red, maculopapular exanthem - 0.5cm - 2.0cm. Scattered sparsely myalgia				Y					Y	10/14/2008	10/15/2008	1	pending	PVT	PVT		Epilepsy; Demyelination	DEPAKOTE causes ataxia and contraceptives cause headaches			1						1	Contusion; Erythema; Myalgia; Pain in extremity; Rash maculo-papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8912U~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0551X~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0329501	10/21/2008	OH	91.0	91		F	10/21/2008	Patient received (IM) Flu injection in left deltoid muscle on 10-1-08, Patient reports that since that day she has difficulty lifting her arm to do normal AOL'S, such as putting her hair up. Patient has seen her pcp who recommended, per patient, physical therapy. symptoms persist to 10-21-08.									N	10/01/2008	10/01/2008	0	Unknown	OTH	PUB		None Given	None Given			1						1	Activities of daily living impaired; Injected limb mobility decreased	FLU3~CSL LIMITED~02049111A~3~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0329436	10/22/2008	FL	67.0	67		M	10/22/2008	Shot was given about 11am about 5:30 started to feel chilly, about 9:30 had chills, and at 11:30 developed fever of 101.8, very thirsty. I gave him 2 Tylenol and water, and sent him to bed. I will check him in about an hour or 2.  He gets a flu shot every year, this is the 1st time he ever had a reaction to it.									U	10/21/2008	10/21/2008	0		UNK	UNK		None	None			1						1	Chills; Pyrexia; Thirst	FLU3~SANOFI PASTEUR~U2790AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329534	10/22/2008	NJ	64.0	64		F	10/20/2008	1hr after flu shot and pneumonia shot had aching joints, itching, hives, sweating and chills, pain over all body, loss appetite, neurological symptoms joints.									U	10/08/2008	10/08/2008	0		PUB	PVT	Prinivil  generic, Syntheroid, vicodan	High Blood Pressure	Allergic Aspirin,Tetracycline, Motrin, Latex	Paralysis~Rubella (no brand name)~1~32.00~In Patient		1						1	Anorexia; Arthralgia; Chills; Hyperhidrosis; Neurological symptom; Pain; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0329535	10/22/2008	VA	27.0	27		F	10/08/2008	Onset 0300, awoke with dizziness, nausea, numbness in fingertips to elbows. Also had a high heart rate with chest tightness, syncope, tremors.				Y					Y	10/07/2008	10/08/2008	1	CBC, CMP, UA	PVT	UNK		None	None; NKMA			1						1	Chest discomfort; Dizziness; Full blood count; Heart rate increased; Hypoaesthesia; Metabolic function test; Nausea; Syncope; Tremor; Urine analysis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA173AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0329536	10/22/2008	IL	60.0	60		F	10/16/2008	arm pain (entire arm). Limited range of motion									Y	09/29/2008	09/29/2008	0	No	PUB	PVT	Dyazide;  Nadolol;  Vasectomy		Hypertension; Previous breast cancer; Vsectomy			1						1	Mobility decreased; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8974S~7+~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0329537	10/22/2008	CA	1.3	1	.3	F	10/17/2008	Generalized hives 1 hour after and swelling face/eyes.  DTAP and Flu vaccines given.  Epinephrine 1:1000 at 12cc SQ and Benadryl 1 tsp (12.5 mg) PO.  Prelone 1 tsp x 1 (x 3 days more).				Y					Y	10/17/2008	10/17/2008	0		OTH	UNK	None					1						1	Eye swelling; Swelling face; Urticaria	DTAP~SANOFI PASTEUR~C2955BA~4~UN~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2787EA~3~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329538	10/22/2008	PA	28.0	28		F	10/15/2008	Pt was inadvertently given 1ml of FLUZONE instead of correct 0.5 ml dose. Pt reported no skin reaction and no adverse events									Y	09/09/2008				PVT	PVT			Pt is pregnant. Was 8 wk 5 days when vaccinated.			1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~U2758AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329539	10/22/2008	TX	58.0	58		F	10/15/2008	6 hours after - very short of breath - pounding heart - heavy chest - chills - slept 16 hours - thought about emergency room.									Y	10/03/2008	10/03/2008	0	None	PVT	PVT	Paroxitone - 20mg/daily; Metoprolol - 50mg/daily	None	Had pneumonia in 2003			1						1	Chest discomfort; Chills; Dyspnoea; Hypersomnia; Palpitations	FLU3~SANOFI PASTEUR~U2806AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329540	10/22/2008	MO	57.0	57		F	10/13/2008	Fainted 3P=120/64 at 10:15, pale in color, warm clammy skin.  Pt had not eaten breakfast.  Came too and was alert and oriented x3 rested on floor, drank juice, and was feeling better.  Color pink, pt. walked to car with parish nurse's husband at her side at 10:35									Y	10/12/2008	10/12/2008	0		PUB	PVT		None				1						1	Cold sweat; Pallor; Skin warm; Syncope	FLU3~SANOFI PASTEUR~U2749AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329616	10/22/2008	VT	15.0	15		F	10/22/2008	Patient had clonic / tonic seizure lasting aproximately 60 seconds.				Y					Y	10/22/2008	10/22/2008	0	CT Head	PUB	PUB	PAMPRIN given 10/21/08		Chronic functional abdominal pain			1						1	Grand mal convulsion; Scan brain	FLU3~SANOFI PASTEUR~U2829AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB247AA~1~IM~RA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U273AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B020AA~UNK~IM~RA~TDAP (BOOSTRIX)~1	USA	Emergency room visit	Influenza
0329619	10/22/2008	MT	61.0	61		F	10/15/2008	I began to have discomfort on the right side of my body, both front and back, about 3 inches above my waist. Sometimes it is fairly intense itchy sensation and other times there is a pricking sensation. The degree of redness varies and there are some tiny blisters like spots.									Y	10/09/2008	10/11/2008	2	None	PUB	PVT	ZOCOR; Urelle	None	LOMITIL			1						1	Blister; Discomfort; Erythema; Pruritus	FLU3~SANOFI PASTEUR~U2766AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB584AA~1~IM~LA~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB251CA~1~IM~RA~HEP A (HAVRIX)~1|TDAP~SANOFI PASTEUR~C2998BA~1~IM~LA~TDAP (ADACEL)~1|TYP~SANOFI PASTEUR~B0347~1~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|VARZOS~MERCK & CO. INC.~1207X~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0329620	10/22/2008	NH	3.0	3		M	10/22/2008	Crying and limp about 1/2 hour after immunization. Cried all day. Labored breathing, fever 8 hrs after immunization, and most of night OK the next day.									Y	10/18/2008	10/18/2008	0	None	PVT	PUB	None	URI	None			1						1	Crying; Dyspnoea; Hypotonia; Pyrexia	FLU3~SANOFI PASTEUR~U2797DA~4~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329621	10/22/2008	TX	23.0			M	10/22/2008	Noticed itching on the 13 Oct then on 15 Oct he had the appearance of a rash approx 15 days post vaccination with SPV, AVA #1 Typhoid, and Influenza. The SPV site is healing well, and the SM has numerous lesions on his legs, arms and chest. Described as maculo papular with areas containing central clearing. Other than itching, he is feeling well. DX - erythema multiforme				Y					Y					MIL	MIL	denies	denies	denies			1						1	Erythema multiforme; Pruritus; Rash; Rash maculo-papular; Skin lesion	ANTH~MICHIGAN DEPT PUB HLTH~FAV149~UNK~SC~UN~ANTHRAX (NO BRAND NAME)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500562P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~UNKNOWN MANUFACTURER~420072~UNK~~UN~SMALLPOX (NO BRAND NAME)~1|TYP~SANOFI PASTEUR~A0522~UNK~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0329623	10/22/2008	FL	45.0	45		F	10/22/2008	Hives, red, itchy below injection site.  Down arm.  BENADRYL 25 mg  and DEPOMEDROL 80mg.  Observed pt for 30 min after administration.				Y					Y	10/18/2008	10/18/2008	0	None	PVT	OTH		None	None			1						1	Erythema; Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA154AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0329625	10/22/2008	AR	45.0	45		F	10/14/2008	Left deltoid inflammed at site of flu and pneumoniavaccine. States large swelling with heat and tenderness, lasting 5 days on 10/14/08. States area just looks bruised without as much swelling today.									Y	10/09/2008	10/10/2008	1		PVT	PUB		Hip Pain				1						1	Injection site haematoma; Injection site inflammation; Injection site pain; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89619~7+~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1084U~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329626	10/22/2008	MI	28.0	28		F	10/22/2008	At 1pm, I started to feel nauseated.  Soon after I started to feel dizzy.  The dizziness elevated to extreme and I felt a hot/flushed sensation starting at the top of my head down.  Once the hot sensation was over, I felt a tingling sensation.  Once those sysmptoms had subsided, my legs became weak.  I did not actually have a docotor visit, however a physcian assistant examined me.  I went home early from work and took Motrin.  I had 2 more epsidodes of dizziness that evening, not as severe.  Today (the next day) I am not experiencing any of the above symptoms, however I feel a little off balance.									Y	10/21/2008	10/21/2008	0	None	PVT	UNK	None	None	None			1						1	Balance disorder; Dizziness; Feeling hot; Flushing; Muscular weakness; Nausea; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329627	10/22/2008	TX	38.0	37		F	10/22/2008	left upper arm 11/2 by 11/2 area warm to touch, slight swelling and redness									Y	10/21/2008	10/22/2008	1		PUB	PVT	none	no	Employee answers no			1						1	Erythema; Skin warm; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA374AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0329629	10/22/2008	CA	44.0	44		M	10/22/2008	Got shot at 1pm.  Started getting tickle in throat by 4pm.  Difficulty swallowing by 5pm.  Blood shot eyes.  Filmy eyes, with what looked like mucous.  Took 2 benedryl.									Y	10/21/2008	10/21/2008	0		UNK	PVT						1						1	Dysphagia; Eye discharge; Ocular hyperaemia; Throat irritation	FLUX~UNKNOWN MANUFACTURER~~1~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329630	10/22/2008	CA	48.0	48		F	10/22/2008	Flu shot received at clinic on 10/21 at approximately 11:30 am; Minor flu symptoms began occuring by ~3pm (achy muscles/tiredness)followed by prolonged heart palpitations which continued through the evening.  Full recovery status unknown (still experiencing some chest tightness the following day)									U	10/21/2008	10/21/2008	0		UNK	UNK	None	None	Minor mitro valve prolapse	None~ ()~~0.00~Patient|None~ ()~~0.00~Sibling|None~ ()~~0.00~Sibling		1						1	Chest discomfort; Fatigue; Influenza; Myalgia; Palpitations	FLUX~SANOFI PASTEUR~U2748AA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329631	10/22/2008	WV	62.0	62		F	10/22/2008	Employee reported dizziness that started approx. 15 min. after receiving the flu vaccine.  She rated the severity of dizziness as a 7 on scale of 1-10.  The employee was seen in the ED department and prescribed Antivert.  Currently she is still dizzy, 24 hrs later, and continues to take the Antivert as prescribed.  She reports treatment has decreased the dizziness from a 7 to a 2 on scale of 1-10.  The employee also has a knot about the size of a quarter and warmth at the injection site, no redness.  The employee also reports achy joints the day after the vaccination.				Y					N	10/21/2008	10/21/2008	0		UNK	UNK	oxaprozin, Toprol XL, Activella, omeprazole	none	osteoarthritis			1						1	Dizziness; Injection site mass; Injection site warmth	FLU3~SANOFI PASTEUR~U2759AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329632	10/22/2008	PR	47.0	47		M	10/22/2008	All started with nasal congestion, and headaches about 36 hours after vaccine administration.  After had to be absent to work for three days because had the above mentioned symptoms and tiredness, joint ache, and irritability.  I took tylenol every 6-8 hours and stayed in bed resting.  Took three days to completely recover.									Y	10/18/2008	10/19/2008	1		MIL	MIL		None	None			1						1	Arthralgia; Fatigue; Headache; Impaired work ability; Irritability; Nasal congestion	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0329633	10/22/2008	WA	46.0	46		F	10/22/2008	Within 24 hours, developed headache, coryza, puffy eyes, and then itchy erythematous rash beginning at vaccine site L deltoid and spreading over 4 days to include most of L upper arm. Seen on 10/13/08.  Given a single shot of epi 0.3ml sq, and hydroxyzine 50 mg po x 1,  with resolution of headache within an hour, other symptoms gradually over next 2.5 days, no recurrance.									Y	10/08/2008			none	PVT	PVT	pravastatin 40mg qd; furosemide 20mg qd; lisinopril 5mg qd; estradiol 2mg qd; albuterol inhaler 2 puffs prn	none.	Chronic Hepatitis C; cluster migraine; hx of thyroiditis, with thyromegaly; hyperlipidemia; impaired fasting glucose; anaphylaxis to bee stings; latent Tb (positive PPD); depression.  Allergies to penicillin, cephalexin, bee stings, benadryl, claritin, codeine.			1						1	Eye swelling; Headache; Injection site erythema; Injection site pruritus; Injection site rash; Rhinitis	FLU3~SANOFI PASTEUR~U2808A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0622X~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329635	10/22/2008	AL	52.0	52		F	10/22/2008	Imm flu vaccine 10-15-2008 2pm. Pt. states awoke 8am with stiffness. Malaise, fever, aching all over. Temp. 99 @ 2:30p today. 10-17 phone call to following- o.k. after 24 hours pt. states.									Y	10/15/2008	10/16/2008	1		UNK	UNK		none	back pain		AL0827	1						1	Malaise; Musculoskeletal stiffness; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2829AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329636	10/22/2008	MD	53.0	53		F	10/22/2008	Location: flu shot clinic set up in grocery store. Received flu shot around 4:30 pm.  I started feeling nauseous and fatigued around 8:30 pm or so.  Around 10 pm I sat down on the sofa and noticed I couldn't stop shaking and shivering, and my teeth were chattering. I pulled a throw blanket over me, thinking maybe I was just cold. But I couldn't stop the shaking and teeth-chattering. That continued for 1 1/2 hours until I fell asleep curled up on the sofa at 11:30 pm. Before I fell asleep I felt feverish, and took my temp.; it was 99.6. When I woke up an hour later at 12:30 am, the shivering had stopped, but my temperature was up to 100.9, and I was still nauseous and aching. The injection site looked normal, but I couldn't tell if it was warm because I was so feverish. I took an extra-strength Tylenol and went to bed. This morning I feel fine, just fatigued. My temperature at noon today is 99.0. Injection site appears normal.									Y	10/21/2008	10/21/2008	0		UNK	UNK	Fosamax 70mg once a week, and daily vitamins and calcium.					1						1	Body temperature increased; Chills; Fatigue; Nausea; Pain; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA179AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0329638	10/22/2008	OH	2.0	2	.3	M	10/22/2008	No adverse reactions reported.  Child received 0.5 ml of Fluzone.										10/20/2008				PUB	PVT		NO	None reported			1						1	Incorrect dose administered; No adverse event	FLU3~SANOFI PASTEUR~U2741AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329639	10/22/2008	WA	11.0	11		F	10/22/2008	Patient experienced a syncopal episode with possible generalized seizure activity, with urinary incontinence after receiving 5 vaccinations at approx. 4:45-5 p.m. on 10/21/08. She was immediately aroused with smelling salts by the RN and the supervisor was notified.  After the incident the client was pale, slight diaphoretic,cool,clammy, and sluggish.  Vitals signs after syncopy were BP 90/76, HR 70, RR 32 with repeat set after 15 mins. BP 90/76, HR 56, RR 32. Pt. was laid down, placed on 4-5L oxygen per mask, and observed for 30-45 mins. She then was alert, and oriented to person, place, and time, more verbal, and without balance problems.  She was then referred to urgent care hours at her drs. office for follow up.				Y					U	10/21/2008	10/21/2008	0	n/a	UNK	UNK	Unknown	None	None listed	Unknown~ ()~~0.00~In Patient		1						1	Cold sweat; Feeling cold; Hyperhidrosis; Pallor; Sluggishness; Syncope; Urinary incontinence	FLU3~SANOFI PASTEUR~U2806AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0548X~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2730AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C3027AA~UNK~IM~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~0975X~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0329640	10/22/2008	OR	55.0	55		F	10/22/2008	CASE RECEIVED TDAP AND INFLUENZA VACCINES AT A FLU CLIN, 15-20 MINUTES LATER HAD SUDDEN ONSET OF NAUSEA, DIAPHORESUS, DIARRHEA AND NEAR SYNCOPAL EPISODE. SHE HAS HISTORY OF HTN AND BEFORE INCIDENT BP 152/98, FIFTEEN MINUTES AFTER BP 114/66. SHE DESCRIBES RESOLUTION OF SYMPTOMS 20 MINUTES AFTER ONSET, TO ER FOR OBSERVATION ONLY.				Y					Y	10/18/2008	10/18/2008	0		UNK	PUB	LISINOPRIL, HYDROCHLOROTHIAZIDE, METOPROLOL,BABY ASA	NONE	ALLERGY TO TREE NUTS/HISTORY OF HTN			1						1	Hyperhidrosis; Immediate post-injection reaction; Nausea; Presyncope	FLU3~SANOFI PASTEUR~U2806AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2997AA~UNK~IM~~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0329641	10/22/2008	MD	46.0	46		F	10/22/2008	40 minutes after vaccine,complained of throat swelling,palpitations. Diagnosed in ER as anaphylactic reaction. Treated with epinephrine,Benadryl and solumedrol.				Y					Y	10/15/2008	10/15/2008	0	none	PVT	PVT	advair,albuterol,claritin	mild cold and cough,resolving	asthma, seasonal allergies, history of anaphylactic reaction to an allergy shot 5 years ago.			1						1	Anaphylactic reaction; Palpitations; Pharyngeal oedema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88132~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0329642	10/22/2008	FL	73.0	73		F	10/22/2008	vomiting, sweats, shortness of breath, weakness, chest discomfort.  911 call was dispatched to my home and they administered oxgen and an iv before transporting me to the emergency room.  symptoms began around 2:00 pm and continued to worsen until iv and oxygen were administered.				Y					Y	08/21/2008	08/21/2008	0	syptoms were similar to heart attack - tests and blood work were determined negative for heart attack,	PVT	UNK						1						1	Asthenia; Blood test normal; Chest discomfort; Dyspnoea; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflla185aa~UNK~~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0329645	10/22/2008	MN	59.0	59		M	10/16/2008	Given flu shot at 3:00pm on October 14, 2008. 24 hours later, severe drug reaction on face arms and chest.									U	10/14/2008	10/15/2008	1	None	PVT	PVT	Lisinopril, Sertaline	Colon Cancer	Allergic to Amoxicillin			1						1	Vaccination complication	FLU3~SANOFI PASTEUR~U2793DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329646	10/22/2008	RI	4.0	4		M	10/22/2008	Pt presented in office for area on induration on left deltoid after receiving Dtap two days ago. Area measured 3.5 x 3.75. Mom has been instructed to outline area with pen to watch for further reaction. Treating with Benadryl and cold soaks, watch for systemic reactions.									N	10/20/2008	10/22/2008	2	None.	PUB	PUB	None	None	None			1						1	Injection site induration	DTAP~GLAXOSMITHKLINE BIOLOGICALS~ac14b085ba~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~02848aa~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329648	10/22/2008	NY	45.0	45		F	10/22/2008	Pt vaccinated on day of discharge on 10/12/08 with influenza and pneumococcal vaccines. Pt was vaccinated with both vaccines on the Left arm as requested by pt as per RN. Pt then re-admitted to ED on 10/13/08 c/o fever,redness and swelling to Left upper arm. Pt treated with IV Zosyn and IV Vancomycin. 1/5/09-records received for DOS 10/13-10/17/08-DC DX: Left shoulder redness and swelling. Presented with 1 day C/O shoulder redness and swelling. Injection site reaction. Fever.					Y	4			Y	10/12/2008	10/13/2008	1		UNK	UNK	Decadron,colace,heparin,keppra,lyrica,lexapro,provigil,famotidine,nexium,cabergoline	S/P GBM Resection	NKA 1/5/08-records received- PMH: glioblastoma multiforme diagnosed 3/08.			1						1	Injection site erythema; Injection site swelling; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA364BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0669X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0329649	10/22/2008	CO	65.0	65		F	10/22/2008	Patient had itching in left arm with in a few hours of vaccine administration. Two days later the patient develped an itchy rash on her legs.									N	10/08/2008	10/08/2008	0		UNK	PUB	Levothyroxine 25mg, Cytomel 5mcg	None reported	Penicillin allergy			1						1	Injection site pruritus; Rash pruritic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89124~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0329652	10/22/2008	CO	45.0	45		F	10/22/2008	The day after recieving the Vaccine patient called and left message on our Voice mail complaining of an itch red rash with bumps. Patient also stated she ahd started Ginko Goldmax for mentla health on the same day. Patient was unreachable for further information									U	10/13/2008	10/14/2008	1		UNK	PVT	Ginko Goldmax; Sprintec 28 day; Valtrex 1qm; Vyvance 40ng; Levothyroxin 150mcg; fluoxetine 10mg	Unknown				1						1	Pruritus; Rash erythematous; Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89124~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0329653	10/22/2008	PA	44.0	44		F	10/22/2008	Pain & swelling & heat to site Right deltoid. Awoke next morning with pain under arm & down arm to hand. Increased temp to 101.1. Saw MD that afternoon was started on Keflex. Temp reached 101.8 & were managed with alternating doses of motrin and tylenol on every 2 hr schedule.  She experienced light headedness & nausea feeling out of sorts. Increased temps persisted for 3 days following shot. work loss was 3-1/2 days.				Y					Y	10/06/2008	10/07/2008	1		PUB	PUB	none daily takes inhaler prn	none				1						1	Body temperature increased; Dizziness; Feeling abnormal; Impaired work ability; Injection site pain; Injection site swelling; Injection site warmth; Nausea; Pain in extremity	FLU3~SANOFI PASTEUR~u2757aa~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0090u~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~c2865aa~1~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0329656	10/22/2008	CA	17.0	17		F	10/22/2008	Pt had Gardasil and Fluzone vaccines on 9/15/08. 9/22/08 presented to the office crying with delusions about family members with lethal disease. Pt sent to Hospital to the ER for Neuro consult.  EEG and labwork negative. 3 admits to Hospital and neuro work up. Inconclusive and unknown etiology. 11/14/08-records received for DOS 9/22-9/24/08-DC DX: Major deprssive disorder with psychotic features. Admitted due to changes in behavior and altered  mental status. Increased irritability, staring with right sided twitching.   Follow-up: Continues with psychiatric problems.				Y	Y	2			N	09/15/2008	09/22/2008	7	EEG, MRI, bloodwork 11/14/08-records received-CBC, CMP LFTs normal. UA negative, CK 53. EEG abnormal-generalized slowing of background.	UNK	UNK	Maxalt 5 mg prn migraines	17 year well check visit	Augmentin, Cefzil, Nuts, Zyrtec allergies. Spastic CP, Migraines, had Grp B Strep Meningitis as newborn 11/14/08-records received-PMH: anxiety, cerebral palsy, developmental delay secondary to neonatal group B streptococcal meningitis with seiuzres up to 6 monthg of age and no seizure from that point forward.			1						1	Abnormal behaviour; Blood test normal; Crying; Delusion; Depression; Full blood count normal; Laboratory test normal; Neurological examination; Nuclear magnetic resonance imaging normal; Urine analysis normal	FLU3~SANOFI PASTEUR~U2787EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0229X~1~IM~RA~HPV (GARDASIL)~1	USA	Hospitalisation	Influenza
0329658	10/22/2008	NY	72.0	72		F	10/22/2008	10/7 IMMEDIATE REDNESS AT SITE, 10/9 SWELLING REDNESS AND WARMTH, 10/10 WENT TO CLINIC LESION MEASURED AT 10 INCHES, GIVEN METHYLPREDNISOLONE PACK 10/12 SWELLING REACHED ELBOW, 10/14 SWELLING SUBSIDED.				Y					Y	10/07/2008	10/07/2008	0		UNK	UNK	Atenolol Tablet 25 mg, take 1 tablet(s) by mouth, every day, for 100 day(s). Quantity: 100, No Refills  Amlodipine besylate + benazepril HCl Lotrel Capsule 5;20 mg;mg 1 QD- STARTED BY CARDIO  Sodium levothyroxine Synthroid Tablet 0.088 mg,	Allergic rhinitis; Hypertensive heart disease; Moderate aortic regurgitation; Mild mitral regurgitation; Essential hypertension; Hypercholesterolemia; Hypothyroidism; Osteoarthritis; Localized osteoarthritis of the knee	PENICILLIN, HORSE SERUM Td, POLLENS			1						1	Immediate post-injection reaction; Injection site erythema; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89662~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1381U~2~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0329660	10/22/2008	IA	11.0	11		M	10/22/2008	patient received flu shot and boostrix vaccines. He came back to office about 30 minutes after leaving. His lips were swelling up and his tongue was swelling up. He was having some difficulty breathing.				Y					Y	10/22/2008	10/22/2008	0		PVT	PVT		no illnesses	none			1						1	Dyspnoea; Lip swelling; Swollen tongue	FLU3~SANOFI PASTEUR~u2797ba~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~ac52b024db~UNK~IM~LA~TDAP (BOOSTRIX)~1	USA	Emergency room visit	Influenza
0329661	10/22/2008	CA	61.0	61		M	10/22/2008	swollen, firm, warm to touch indurated area on triceps area of L arm ~ 2.5 inches X 2.5 inches									U	10/20/2008	10/21/2008	1		UNK	UNK	None	Denies illness	Denies any			1						1	Inappropriate schedule of drug administration; Injection site induration; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88634~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0329663	10/22/2008	CA	4.0	4		M	10/22/2008	right deltoid: moderately erythematous almost down to the elbow and almost up to the shoulder									Y	10/20/2008	10/21/2008	1	none	UNK	UNK		none	Pt with bilat optic nerve hypoplasia and developmental delay			1						1	Injection site erythema	DTAP~GLAXOSMITHKLINE BIOLOGICALS~c2958ba~5~IM~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~u2803aa~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~a0996-2~4~SC~LA~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0281u~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0329664	10/22/2008	CA	46.0	46		F	10/22/2008	Received vaccine at Noon 10/21/08.  Within 2 hours, I was coughing, wheezing, short of breath, fatigued.  Severe headache and back ache set in.  At 6:30 pm, temperature was 99.6.  One Advil was taken.  At 7:30 pm, temp was 101.  At 8:00 pm, temp was 102.6 and I was getting dizzy.  I drove to local ER.  Pulse ox was low, pulse and BP high.  Full bloodwork was taken, urine, nebulizer for wheezing.  Discharged 3 hours later with diagnosis of severe reaction to flu vaccine.  Today, I still have low temp, malaise, myalgia, clammy.				Y					U	10/21/2008	10/21/2008	0	All lab work normal, but elevated white cell count	UNK	UNK	Excedrin Migrain, Ducolax Stool softener, Centrum Multivitamin, birth control	None	Fibromyalgia; allergic to Penicillan, Septra	None~ ()~~0.00~In Patient		1						1	Back pain; Body temperature increased; Cold sweat; Cough; Dizziness; Dyspnoea; Fatigue; Headache; Heart rate increased; Hypertension; Immunisation reaction; Laboratory test normal; Malaise; Myalgia; Oxygen saturation decreased; Wheezing; White blood cell count increased	FLU3~SANOFI PASTEUR~49281038215~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329665	10/22/2008	OK	53.0	53		F	10/22/2008	I took the shot yesterday morning at 10:30 a.m.  At mid-morning, my chest began to feel very congested. I began to run fever. My left arm, where I was injected, began to hurt. Through the day my symptoms began to deteriorate. I began to hurt all over my body especially my left arm and surrounding areas. My throat is sore, coughing and sneezing. ONE INCH BELOW THE INJECTION IS A HORRIBLE RED PRICKLY RASH! IT IS VERY SWOLLEN AND VERY HOT!  I will be contacting my doctor tomorrow!  I have only taken the flu shot once before.  I became sick but nothing like this.  WAS THIS A BAD BATCH OF VACCINE?									U	10/21/2008	10/22/2008	1		UNK	UNK		allergies	Dr.	fever, rash, pain,~Influenza (Seasonal) (no brand name)~1~53.40~In Patient		1						1	Cough; Injection site pain; Oedema peripheral; Oropharyngeal pain; Pain; Pain in extremity; Pyrexia; Rash erythematous; Respiratory tract congestion; Skin warm; Sneezing	FLUX~UNKNOWN MANUFACTURER~001~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329667	10/22/2008	CA	61.0	61		F	10/22/2008	8 hours after the flu shot I developed chills, high fever, body aches, headaches, and a cough. At the site of the injection is a 3 inch band of redness that is swollen and hot to the touch. The pain runs from my collarbone and wraps around my left armpit. Today, being the third day, my fever is just below a hundred. The highest was 103. My home treatment has been ibuprofen every 4 hours and cough syrup. Over the years I have had many flu shots and this is the first bad reaction I have experienced. I would like to know if this is common for this years influenza vaccine. My doctor says no one in her practice has complained of symptoms like mine.									N	10/20/2008	10/20/2008	0		PVT	PVT		slight cold				1						1	Chills; Cough; Headache; Injection site erythema; Injection site swelling; Injection site warmth; No reaction on previous exposure to drug; Pain; Pain in extremity; Pyrexia	FLUX~UNKNOWN MANUFACTURER~unknown~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~unknown~1~UN~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0329682	10/22/2008	MO	4.0	4		F	10/22/2008	Reported to Dr immediately. Within 10 min of administration, when ready to leave office pt. told mom didn't feel well. Was pale in face, color around eyes - returned to Rm. checked injection sites - 2 hives noted in Rt leg @ MMR site, torso turning red. Over next 30 min entire body hives. Did BENADRYL 2 tsp. Waited 45 min with help ORAPRED given - within 20 min could see hives reside - watched for another. Hour: condition improved - Dr. discharged to home and mom instructed to go to ER if problems re-occur. Called pt - next day, no further hives. Also note @ time nauseated but no vomiting. Redness noted around 3 out of 4 injection sites - not around KINRIX.										10/17/2008	10/17/2008	0	(Referred to allergist)	PVT	PVT	None	None	None			1						1	Injection site erythema; Injection site urticaria; Malaise; Nausea; Pallor; Urticaria	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B103AB~UNK~IM~LL~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~SPU2806AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1208X~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1215X~2~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0329684	10/22/2008	IN	1.32	1	.3	F	10/21/2008	Patient got shot (first ever) on 10/15/08 and next day broke out in hives. Face first, then whole body. Examined on 10/20/08, still has rash --> given Prelone, Zyrtec.									Y	10/15/2008	10/16/2008	1		PVT	UNK		Runny nose	No			1						1	Rash; Urticaria	DTAP~SANOFI PASTEUR~C2799AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2828AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF196AA~3~IM~RL~HIB (ACTHIB)~1	USA		Influenza
0329685	10/22/2008	CA	43.0	43		F	10/17/2008	Soreness at injection site for 10+ days with some limitation in movement of shoulder. Now has full range of motion (10 days later) but mild persistent pain. Also experienced some soreness right side of neck and 'feeling run down'- these have now elated.									Y	10/07/2008	10/07/2008	0		PUB	PUB	Multivitamins	None	History fracture left arm/shoulder age 12 -states had full ROM			1						1	Fatigue; Injection site pain; Joint range of motion decreased; Neck pain; Pain	FLU3~CSL LIMITED~01749111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0329687	10/22/2008	NC	23.0	23		F	10/22/2008	SM noted pustular rash that started around her inoculation site and has since spread to other arm, legs and back.				Y					Y	10/09/2008	10/17/2008	8		MIL	MIL	Oral Contraceptive	None	None			1						1	Injection site rash; Rash; Rash pustular	ANTH~UNKNOWN MANUFACTURER~~UNK~SC~UN~ANTHRAX (NO BRAND NAME)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~UNKNOWN MANUFACTURER~~UNK~ID~UN~SMALLPOX (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0329689	10/22/2008	CA	12.0	12		M	10/22/2008	He felt hot, he hurts all over, slight cough sore throat and tired all the time.									U	10/21/2008	10/21/2008	0	No	PVT	PVT	None	No	No			1						1	Cough; Fatigue; Feeling hot; Oropharyngeal pain; Pain	FLU3~SANOFI PASTEUR~U2786BA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2669AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2997AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0329691	10/22/2008	AK	1.82	1	.8	F	10/10/2008	Redness heat and swelling at injection site, afebrile. Ultrasound - induration but no abscess trimethroprim and Sulfamethoxole.				Y						10/08/2008	10/10/2008	2	9/30/2008 Swab L thigh abscess 2 + MRSA	OTH	OTH			MSRA Cellulitis, Treated			1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth; Methicillin-resistant staphylococcal aureus test positive	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B064AA~UNK~IM~RL~DTAP (INFANRIX)~1|FLUX~UNKNOWN MANUFACTURER~VT27866AA~UNK~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0329693	10/22/2008	AK	41.0	41		F	10/23/2008	Chest tightness, short of breath, fever				Y					Y	10/18/2008	10/19/2008	1	Glucose 226, Chest X-Ray WNL, WBC 11.8, DDimer Quant WNL	UNK	UNK	Metfirmin, Avapro, Byata					1						1	Blood glucose increased; Chest X-ray normal; Chest discomfort; Dyspnoea; Fibrin D dimer normal; Pyrexia; White blood cell count increased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFUA157AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0329696	10/22/2008	IL	76.0	76		M	10/22/2008	Per patient started itching everywhere and redness at site approx. Oct. 3rd and 4th. Sent to Allergist and received a Rx MEDROL dose pak.									Y	10/02/2008	10/03/2008	1	Per allergist skin test	PVT	OTH		None	PCN; CARDIZEM; ZANTAC			1						1	Injection site erythema; Pruritus; Skin test	FLU3~SANOFI PASTEUR~U2756AA~5~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329698	10/22/2008	CA	38.0	38		F	10/22/2008	4-6 hrs. after administration of vaccine, pt. states she had bodyaches, clammy feeling, felt light headed, denies passing out.  Condition got worse, she was eventually taken to an urgent care on 10/19/08.  While in UC, she claims she passed out, she was then transported to an ER via 911. 10/23/08-records received with report-presented to ED 10/19/08 with C/O weakness, nausea, body ache, headache since day after flu shot. Crying.Observed in ED no fevers or chills. Depressed recently and now ready to go home.  DX: Headache resolved. Depression.				Y					Y	10/15/2008	10/15/2008	0	Lab work and IV fluid 10/23/2008-records received-CT normal, labs normal.	PVT	PVT	Acetaminophen-Codeine; CYMBALTA; desonide; MIRAPEX; mometasone furoate; oxycodone-acetaminophen; promethazine; ROBAXIN; TOPAMAX; trazodone	c/o sinus pressure & rhinorrhea; angular cheilitis; compression arthralgia of the knee/patella/tibia/fibula; hyperlipidemia; nicotine dependence	Clindamycin; DILANTIN; IMITREX; influenza virus vaccine split; KEFLEX; morphine sulfate; penicillins; sulfa drugs; TORADOL; ZOFRAN; history of head injury; history of opioid dependence 10/23/08-records received-PMH:brain injury.			1						1	Cold sweat; Dizziness; Loss of consciousness; Pain	FLU3~SANOFI PASTEUR~U2755AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329699	10/22/2008	CA	76.0			F	10/04/2008	Patient called clinic 10/17/08 with complaint of area of redness about 4 long (L) arm 4 hardened/swollen area about size of two half dollars, after pneumococcal vaccine on 10/15/08, supportive care advice given, patient contacted on 10/20/08 and noted has complete resolution of symptoms.									Y					MIL	MIL						1						1	Injection site erythema; Injection site induration; Injection site swelling	FLU3~CSL LIMITED~0144911A~7+~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~1960U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329700	10/22/2008	TN	70.0	70		F	10/18/2008	Redness, Swelling, Warm to touch, achiness, Pt applied ice on Wednesday night- night of injection										10/15/2008	10/15/2008	0		OTH	UNK			FOSAMAX, NASONEX, ESTRADIOL SYNTHROID, VESICARE			1						1	Erythema; Pain; Skin warm; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328945	10/23/2008	NE	25.0	25		F	10/14/2008	Sudden onset of dizziness increased heart rate and blood pressure, sore an thick feeling in throat and slight shortness of breath after taking Flu vaccine onset of symptoms developed when returned to nursing unit.				Y					Y	10/14/2008	10/14/2008	0	Routine Chemistry Pregnancy Test	PUB	PVT	Birth Control Pills	None	Environmental Allergies			1						2	Unevaluable event; Blood pressure increased; Dizziness; Dyspnoea; Heart rate increased; Immediate post-injection reaction; Oropharyngeal pain; Pregnancy test; Throat tightness	FLU3~SANOFI PASTEUR~U2766AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2766AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0329668	10/23/2008	NE	47.0	47		M	10/23/2008	I received my flu shot at 0130 on Oct 21 from RN for employee health.  At 0615, I was having some muscle and joint aches. (I work the night shift)  About 1200 the pain was a 7.  I was having the chills and headache. At 1600, I had a time of 102.2 severe muscle and joint pain at pain scale of a 12 and at 2000 it has 102.8. at 1600 I took tylenol 1000 mg, and at 2000 I took tylenol 1500 mg.  On Oct 22, at 0400, I woke up was still achey but temp was 101.0 and at 0800 it was 99.1, I still felt achey and I still feel achey at 0300 on Oct 23.  I called in sick on Oct 21, I was to work 2400 to 0600.									U	10/21/2008	10/21/2008	0		UNK	UNK	Zoloft 150 mg q day, Wellbutrin SR 150 mg 1 tablet BID, Androgel 25 mg 1% -3 packets q day. Singulair 10 mg 1 tablet q day.	none	essential tremors, xxy Klinefelters Syndrome, Sleep Apnea, allergies, oranges, bananas, fish, cucumbers, rye, peanuts, wheat, tomatoes, (watermelon, cantelope, honeydew, -related to family of Ragweed) ragweed, pigweed, russian thistle, english plantain, short ragweed, trees: elm, ock, maple, poplar, hash (oak), cottonwood. Molds: Alternaia phoma,  grass: June rye,			1						1	Activities of daily living impaired; Arthralgia; Body temperature increased; Chills; Headache; Impaired work ability; Myalgia	FLUX~UNKNOWN MANUFACTURER~unknown~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329733	10/23/2008	KY	37.0	37		F	10/21/2008	Initial report was received 13 October 2008 from a consumer, who is also the patient.  A 37-year-old female patient with a medical history of irritable bowel syndrome, arthritis, and frequent urinary tract infections, had received an intramuscular left deltoid injection of FLUZONE, lot number U2741AA on 09 October 2008 and five hours post vaccination, the patient developed a fever, chills, aches, weakness, and her left arm was hurting and sore to touch.  The following day, 15 hours post vaccination, the patient complained of weakness, dizziness and passed out cold.  The patient was evaluated by her physician (date not reported) and laboratory and diagnostic tests were performed (dates of testing not reported).  The patient had normal CBC, BMP, and EKG results, and an echocardiogram had been scheduled, but had not yet been performed.  Information pertaining to the patient's recovery status for fever, chills, aches, dizziness, passing out, and left arm hurting and sore was not provided, however the symptom of weakness continued.  At the time of the report, the patient had not recovered from the event.  Documents held by sender: None.				Y					N	10/09/2008	10/09/2008	0	CBC, BMP, and EKG - (dates not provided) all normal as per patient report.  Echocardiogram: had been scheduled at the time of the report.	UNK	UNK	Ibuprofen, Vitamins		The patient had no allergies, no illness at the time of vaccination and had received any other vaccinations within four weeks of FLUZONE vaccination. The patient had a past history of IBS (irritable bowel syndrome), arthritis, and frequent UTI's (urinary tract infections). The patient received FLUZONE ten times previously without no adverse events reported.		200803171	1						1	Asthenia; Chills; Dizziness; Electrocardiogram normal; Full blood count normal; Loss of consciousness; Metabolic function test normal; Pain; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U2741A~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329734	10/23/2008	OK	48.0	48		F	10/21/2008	This serious case was received from a health professional on 16 October 2008.  A 48-year-old female patient received an intramuscular left deltoid injection of FLUZONE (lot number U2804AA) on 15 October 2008.  Medical history included hypothyroidism, seasonal allergies, and childhood allergies to chocolate, peanuts, Betadine, and feathers.  Concomitant medications included Zyrtec and Synthroid.  She was not ill at the time of vaccination, and had not experienced any adverse events following previous vaccinations.  Approximately three hours after vaccination, the patient developed heartburn, cough, chills, burning eyes, generalized achiness, feverish sensation, vaginal burning, nasal congestion, and post-nasal drip.  Approximately five hours after vaccination, she complained of difficulty breathing, chest tightness, shortness of breath, tongue swelling, itching, and that her skin hurt.  She self-treated her symptoms with Benadryl, and then went to bed.  Upon awakening the next morning, she noted that her eyes were bloodshot, had drainage and were stuck together.  She had not sought medical attention, and at the time of the report the outcome was unknown.  Documents held by sender: None.  The reporter in this case also reported an event for another patient (radiating tingling and numbness), captured in case number 2008-03234.				Y					U	10/15/2008	10/15/2008	0		OTH	OTH	Synthroid, Zyrtec		Medical history included hypothyroidism and seasonal allergies.  Childhood allergies included chocolate, peanuts, betadine, and feathers.		200803233	1						1	Chest discomfort; Chills; Cough; Dyspepsia; Dyspnoea; Eye discharge; Eye irritation; Nasal congestion; Ocular hyperaemia; Pain; Pain of skin; Postnasal drip; Pruritus; Pyrexia; Swollen tongue; Vulvovaginal burning sensation	FLU3~SANOFI PASTEUR~U2804A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329735	10/23/2008	OK	29.0	29		F	10/21/2008	This serious case was received from a health professional on 16 October 2008.  A 29-year-old female patient, with a history of malignant hyperthermia, received an intramuscular right deltoid injection of FLUZONE (lot number U2804AA) on 26 September 2008.  Within five to eight minutes of vaccination, the patient began complaining of tingling in her lips and right-sided facial numbness.  Within 30 minutes of vaccination, she felt very hot and could not cool down.  Within an hour of vaccination her face became flushed, and she complained of tingling and numbness in the right arm radiating to the neck, face, and mouth.  She was seen in the emergency room and treated with Benadryl.  The symptoms gradually cleared, and the patient was discharged.  She denied any illness at the time of vaccination, and had not experienced any adverse events following previous vaccinations.  Concomitant medications included Tylenol and Aleve as needed.  The event was considered to be resolved.  Documents held by sender: None.  The reporter in this case also reported an event for another patient, captured in case number 2008-03233.				Y					Y	09/26/2008	09/26/2008	0		OTH	OTH	TYLENOL, ALEVE		History of malignant hyperthermia.		200803234	1						1	Feeling hot; Flushing; Hypoaesthesia; Hypoaesthesia facial; Immediate post-injection reaction; Paraesthesia; Paraesthesia oral	FLU3~SANOFI PASTEUR~U2804A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329736	10/23/2008	IA	62.0	62		F	10/21/2008	Initial report received from a health professional on 17 October 2008.  A 62-year-old female patient received a right deltoid intramuscular injection of FLUZONE SV 2008-2009 (lot number U2747AA) on 16 October 2008 (reported as 16 October 2007) and three hours later, she complained of injection site redness and hotness.  The patient went to the emergency room later in the day due to shortness of breath.  She received Prednisone for the injection site redness and was released.  Outcome was reported as 'unknown'.  Documents held by sender: None.				Y					U	10/16/2008	10/16/2008	0	Unknown	OTH	OTH			History of Sulfa allergy.  'None reported' was indicated for the following: pre-existing medical conditions, concomitant medications, other vaccinations within four weeks of 16 October 2008.  Illnesses at time of vaccination was not reported.  The patient had not experienced any reactions to two previous doses of FLUZONE.		200803241	1						1	Dyspnoea; Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U2747A~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329737	10/23/2008	CA	39.0	39		F	10/21/2008	Initial report received from a healthcare professional on 17 October 2008.  A 39-year-old female patient had received a left deltoid intramuscular injection of FLUZONE SV 2008-2009 (lot number U2745AA) on 15 October 2008 at 11:30 AM and that evening, she experienced fever (temperature unknown), chills, aches and vomiting.  The patient had a history of cough for one week prior to the vaccination.  She was hospitalized on 16 October 2008.  At the time of the report, outcome was 'not recovered' and the patient remained hospitalized.  No additional details were provided.  Documents held by sender: None.					Y	0			N	10/15/2008	10/15/2008	0	Not reported	PVT	OTH			The patient had a cough for one week prior to the vaccination.  'None reported' was indicated for the following: additional pre-existing allergies/medical conditions; additional vaccinations within four weeks of 15 October 2008; concomitant medications prior to vaccine; adverse events following prior vaccinations.		200803244	1						1	Chills; Pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2745A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0329739	10/23/2008	MA	52.0	52		F	10/20/2008	Vaccine 10/13/08 4 pm.  10/13/08 9 pm pain, heat, itching at injection site.  10/14 AM swelling, pain, heat, itching.  ? cellulitis.  BENADRYL 50 mg and sent to ER.  Received I.V. vancomycin.  Admitted for 24 hours +.  Dc'd 10/18/08 on P.O antibiotics (KEFLEX) 10/20/08.  Denies S/S at this time. 11/17/08-records received 11/17/08-presented to ED with C/O fever and increased pain, decreased range of motion in right arm. Nausea and vomiting.  DX Right upper extremity cellulitis.				Y					Y	10/13/2008	10/13/2008	0	11/17/08-records received- WBC 11.0, neutrophils low 39, lymphocytes high 50.1.	PVT	PVT	none	none	none			1						1	Injection site pain; Injection site pruritus; Injection site warmth; Pain; Pruritus; Skin warm; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89982~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0329741	10/23/2008	MN	4.0	4		M	10/20/2008	Sat 4 PM - fever 102 degrees - 103 degrees F (10-18-08). LAIV given to patient (10-17-08). Sleepy - lethargic (per Dad) not seen in clinic or triaged by clinic staff.									Y	10/17/2008	10/18/2008	1	None	PVT	PVT	None known	None noted				1						1	Lethargy; Pyrexia; Somnolence	FLUN3~MEDIMMUNE VACCINES, INC.~500567P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0329742	10/23/2008	MI	42.0	42		F	10/17/2008	Fever (flushed/warm), headache, joint pain, muscle weakness, skin sensitivity to touch, lips and circumoral area numb feeling, and hard to breathing. Had to my inhaler 2x and next morning. Started 6 hrs after flu vaccine. Improved overnight but still using inhaler. Also had blood shot injected eyes which have improved.				Y					U	10/16/2008	10/16/2008	0		OTH	PVT	Albuterol	None	EIA			1						1	Arthralgia; Conjunctival hyperaemia; Dyspnoea; Flushing; Headache; Hyperaesthesia; Hypoaesthesia oral; Muscular weakness; Pyrexia; Skin warm	FLU3~SANOFI PASTEUR~U2832AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329745	10/23/2008	TX	62.0	62		F	10/20/2008	The patients arm immediately swelled at the injection site. She reports no itching. It looks like the amount was not absorbed into muscle, but under skin. Gave cold compress.									U	10/20/2008	10/20/2008	0		PUB	PVT		None	None			1						1	Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0329748	10/23/2008	CA	49.0	49		M	10/19/2008	On 18 Oct 2008, service member rec'd Flu mist via nostril at about 1330. Service member subsequently experienced nose bleeding from bilateral nostrils @ about 1730 - It was a large amount per service member. At about 2130, service member experienced another nose bleed and was apparently more per service member. After both episodes, bleeding was controlled via conservative means (i.e. 2 pressure, cool packs).									Y	10/18/2008	10/18/2008	0	Only Physical Assessment by Dr.	MIL	MIL	Service member currently takes Atenolol for hypertension	None	Hypertension			1						1	Epistaxis	FLUN3~MEDIMMUNE VACCINES, INC.~500552P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0329749	10/23/2008	OH	54.0	54		F	10/21/2008	I am a nurse practitioner employed by minute clinic. A colleague administered the vaccine (INFLUENZA 2008/2009) on 10/17/08. That evening I experienced true rigors lasting about 1 hr.									Y	10/17/2008	10/17/2008	0	None	PVT	OTH	SYNTHROID; WELLBUTRIN; PREMARIN	None	Hypothyroidism; situational depression (well controlled)			1						1	Chills	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0329751	10/23/2008	WI	10.9	10		F	10/20/2008	VZV given (L) deltoid (10/17/08). Erythema/ +1 - induration swelling noted 10/19/08 (PM) worse AM. 10/20 - seen late in day - resolving/ no sign cellulitis.				Y					Y	10/17/2008	10/19/2008	2		PVT	PVT			Amoxicillin; Cats; Asthma; allergic rhinitis			1						1	Erythema; Induration; Swelling	FLU3~SANOFI PASTEUR~U2789DA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0990X~2~UN~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0329754	10/23/2008	IL	5.0	5		F	10/21/2008	Local site reaction (erythema, swelling, itching) approximately 24 hrs after vaccination with flu vac. in left quad. At time of exam, redness and swelling was 12.5 cm in diameter.									Y	10/15/2008	10/16/2008	1	None	PVT	PVT	None	None	None diagnosed; has had hives x 2 with no known cause			1						1	Erythema; Local reaction; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U2790AA~3~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB259AA~2~UN~RL~HEP A (HAVRIX)~1	USA		Influenza
0329755	10/23/2008	CO	58.0	58		F	10/13/2008	Hives on arm and chest. Took diphenhyramine, resolved in two days.									Y	10/11/2008	10/12/2008	1		OTH	PVT			sulfa allergy			1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0990U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329756	10/23/2008	MD	0.8	0	.8	F	10/20/2008	Patient with episode arms and legs shaking, unable to suck on pacifier and difficulty holding head upright patient crying throughout episode; episode lasted about 10-15 minutes. Patient seen in ER and diagnosed with infantile spasms.				Y					Y	10/07/2008	10/07/2008	0	CBC and BMP done in ER Normal	PVT	PVT	None	None	None			1						1	Crying; Full blood count normal; Infantile spasms; Metabolic function test normal; Tremor	FLU3~SANOFI PASTEUR~1610U~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~U2001UAA~3~IM~LA~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0329757	10/23/2008	WI	1.3	1	.3	F	10/17/2008	Mild redness (urticarial wheal) at (R) thigh at site of immunization (PREVNAR) began within 24 hours - treated with oral BENADRYL - seen in clinic on 10/17/08				Y					U	10/15/2008	10/16/2008	1	None	PVT	UNK	None	None	None			1						1	Injection site urticaria	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B192CA~UNK~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2790AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C68309~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0329760	10/23/2008	CT	36.0	36		F	10/16/2008	Immediate excruciating pain at injection site. Persistent pain and decreased ROM of shoulder. Confirmed bursitis by MRI treated with steroids.				Y					N	10/08/2008	10/08/2008	0	MRI (+) bursitis	PVT	OTH		None	MTHFR			1						1	Bursitis; Immediate post-injection reaction; Injection site pain; Joint range of motion decreased; Nuclear magnetic resonance imaging abnormal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89975~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C2768AA~UNK~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0329762	10/23/2008	MI	59.0	59		F		Severe swelling, welts (hives from elbow to shoulder. Severe pain - Hydrocortisone cream, BENADRYL 50mg									Y	10/17/2008	10/17/2008	0	None	OTH	PVT	ADVAIR, ZYFLO, YOPAX, ACEON, ATROVENT, PREVACID		PCN, SULFA, LATEX, DILANTIN, ASTHMA			1						1	Oedema peripheral; Pain; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89747~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0329763	10/23/2008	OH	71.0	71		F	10/19/2008	Patient received a FLUVARIN and PNEUMOVAX injection in the same (L) arm on 10/14/08, symptoms started on 10/15/08 per patient. Daughter called and notified me of problem on 10/17/08. Area on upper left arm was hard, bright red and hot to touch. Patient is not aware of which injection is inflamed.									Y	10/14/2008	10/15/2008	1	None	OTH	OTH	HCTZ; Levothyroxine; Metoprolol tartrate; PLAVIX; REQUIP; Simvastatin; Verapamil ER					1						1	Erythema; Induration; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~87950~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1960U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329764	10/23/2008	NY	15.0	14		F	10/15/2008	Reports bald patch at back of head - onset one month after receiving MENACTRA, Flu and GARDASIL 2/11/08, condition has worsened over past 5 months - seen 9/25/08 for this condition. Treated - Triamcinolone - referred to Dermatologist.				Y					U	02/11/2008	03/01/2008	19	None	PUB	OTH	Triamcinolone topical	Eczema	Exercise induced asthma			1						1	Alopecia	FLU3~SANOFI PASTEUR~U2561AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1487U~1~IM~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2481AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0329765	10/23/2008	GA	54.0	54		F	10/19/2008	Weakness, disorientation, visual hallucinations, tachycardia. Occurred approx. 2 hours after administration of flu vaccine, physician notified. BENADRYL given, hospitalist notified (arrived in 10 mins).				Y					Y	10/11/2008	10/11/2008	0		OTH	OTH	Sulfa - allergy	618.01. Cystocele, midline				1						1	Asthenia; Disorientation; Hallucination, visual; Tachycardia	FLU3~CSL LIMITED~03249111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0329766	10/23/2008	PA	26.0	26		F	10/15/2008	Pt was inadvertently given 1mL dose of INFLUENZA vaccine instead of correct 0.5 dose. Pt reported no skin reaction and no adverse events.									Y	09/29/2008				PVT	PVT			Pt is pregnant. Was 32 wks 1 day at time of vaccination.			1						1	Drug exposure during pregnancy; Incorrect dose administered	FLU3~SANOFI PASTEUR~U2758AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329767	10/23/2008	PA	80.0	80		F	10/19/2008	About 1 week after receiving flu shot pt became very sick, went to MD and diagnosed with a severe case of Shingles. Possibly due to flu shot affecting resistance.				Y					U	10/08/2008	10/17/2008	9		OTH	PUB			Heart disease			1						1	Herpes zoster; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0329768	10/23/2008	PA	68.0	68		F	10/15/2008	Pt. was inadvertently given a double dose of the vaccine (FLUZONE 1mL instead of 0.5mL). Pt reported itching and redness at site, which gradually resolved and was completely gone by 10/13/08. Pt was seen in office 10/10 and 10/13				Y					Y	10/07/2008	10/08/2008	1		PVT	PVT						1						1	Incorrect dose administered; Injection site erythema; Injection site pruritus	FLU3~SANOFI PASTEUR~U2758AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329770	10/23/2008	FL	65.0	65		F	10/17/2008	Immediately following vaccine administration soreness/pain in left arm below injection site. Has gotten progressively worse to cause pain that radiates down and into left arm. Patient reports inability to lift left arm on occasion. Dr visit required.				Y					U	09/26/2008	09/26/2008	0		OTH	OTH	CELLCEPT, PROGRAF, NEXIUM, LEVOTHYROXINE, SIMVASTATIN, ACTONEL, TEMAZEPAM, CALCIUM, MAGNESIUM, HYDROCODONE with ACETAMINOPHEN, GLUCOSAMINE and  CHONODROITIN	None	Allergic to LISINOPRIL and SULFA drugs, no birth defect, Medical conditions- Heart transplant and pacemaker, compression fractures, osteoporosis and osteoarthritis			1						1	Immediate post-injection reaction; Injected limb mobility decreased; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0329772	10/23/2008	AL	35.0	35		F	10/16/2008	Chills, fever (101.7), achy, headache, light headed/dizzy, congestion.									Y	10/15/2008	10/15/2008	0		PVT	PVT	Unknown	None	Unknown			1						1	Chills; Dizziness; Headache; Pain; Pyrexia; Respiratory tract congestion	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA350BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0329773	10/23/2008	AL	41.0	41		F	10/16/2008	Diarrhea, very bad headache (similar to a migraine headache), aching, feeling very cold.									Y	10/10/2008	10/10/2008	0		PVT	PVT	Unknown	None	None reported			1						1	Diarrhoea; Feeling cold; Headache; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA350BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0329778	10/23/2008	NJ	79.0	79		F	10/12/2008	Next day, Right arm hurts from shoulder (in back) through elbow down arm through thumb, and is hot to the touch, sight of infection red and puffy. By Sunday, (4 days after shot) all symptoms are gone. No pain or swelling left.									Y	10/08/2008	10/08/2008	0	None	OTH	PUB	NEXIUM, HTC 2, GABAPENTIN, METFORMIN	None	DM, restless leg syndrome			1						1	Feeling hot; Injection site erythema; Injection site swelling; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0619X~2~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329782	10/23/2008	TX	21.0	21		M	10/23/2008	within 30 minutes of receiving the flulaval started having urticaria no hives no SOB.  given 50 mg benadryl IM and within 15 minutes urticaria reduced to minor areas. given 50 mg benadryl QID for 3 days with f/u in 24 hours from time vaccine given. pt was observed for over 1 hour. PT states the last two flu vaccinations resulted in hives or urticaria, was seen by provider and treated with benadryl, but was not told he was allergic. last flu vaccine was flu mist and the only vaccination at the time.  was given anthrax, small pox, typhoid, hep b and a without any urticaria. pt is able to each chicken without urticaria.									Y	10/23/2008	10/23/2008	0	none	MIL	MIL	none. no supplements	none	none	hives~Influenza (Seasonal) (FluMist)~2~20.00~In Patient		1						1	Urticaria; Vaccine positive rechallenge	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflla177aa~4~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0329783	10/23/2008	GA	43.0	43		F	10/23/2008	Patient reported swollen upper right arm with 2 large knots, injection site hot to the touch, and a sore neck. No fever. Symptoms began 2 days after receiving vaccination. All symptoms had resolved after an additional 2 days. Patient also received influenza vaccination in the left deltoid, but reported no adverse reactions at the site.									Y	10/15/2008	10/17/2008	2	None	UNK	PVT		none	none			1						1	Injection site induration; Injection site swelling; Injection site warmth; Neck pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89973~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1382U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329784	10/23/2008	LA	29.0	29		F	10/23/2008	Fever,congestion,cough,headache,runny nose,sore throat,very tired receive the flu shot at work									N	10/17/2008	10/18/2008	1		UNK	PVT		none	none			1						1	Cough; Fatigue; Headache; Oropharyngeal pain; Pyrexia; Respiratory tract congestion; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329785	10/23/2008	TX	45.0	45		F	10/23/2008	On 10.23.08 an area approximately 11/2 by 11/2 oblong on left latersl arm noted. Arm warm to touch reddened area. vaccine administered on 10/21/08. Advised to take an antihistamine at night. will continue to monitor untill resolved									Y	10/21/2008	10/23/2008	2		PVT	PVT	None	None stated	none shared			1						1	Erythema; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA374AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0329787	10/23/2008	MI	19.0	19		F	10/23/2008	NONE									Y	10/17/2008	10/17/2008	0	urine pregnancy test POSITIVE  done after imms given.	PVT	PVT	none	none	none			1						1	Drug exposure during pregnancy; Pregnancy test positive	FLU3~SANOFI PASTEUR~U2745AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB264CA~1~IM~RA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~0250X~1~IM~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2620AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0329789	10/23/2008	WI	30.0	30		F	10/23/2008	Extreme and uncontrollable coughing (this started about 2 hours and 15 minutes after administration of vaccine), wheezing, tachycardia, sweating, swelling of the uvula and back of throat.  An insurance nurse line was called and the nurse instructed us to call 911.  My husband took me to the ER at the closest hospital.  I was there for about 3 hours and received oxygen, an epi pen, steroids, and breathing treatments.				Y					Y	10/22/2008	10/22/2008	0		UNK	UNK	Isotrenin	None	None			1						1	Cough; Hyperhidrosis; Palatal oedema; Pharyngeal oedema; Tachycardia; Wheezing	FLUX~UNKNOWN MANUFACTURER~~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0329791	10/23/2008	TX	5.0	5		M	10/23/2008	marked swelling and redness to entire upper arm that injection was given in. Soreness, tenderness.				Y					U	10/20/2008	10/21/2008	1		PUB	PVT	none	none	none			1						1	Injection site erythema; Injection site swelling; Tenderness	FLU3~SANOFI PASTEUR~U2803AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329792	10/23/2008	NY	4.0	4		F	10/23/2008	RECEIVED FLU SHOT ON 10/9/08 AND WOKE UP WITH LEFT ARM SWOLLEN AND RED 2 DAYS LATER. REDNESS EXTENDED DOWN TO THE ELBOW, ITCHING. NO PAIN WITH TOUCH. ADVISED ICE PACKS AND BENADRYL.									Y	10/09/2008	10/11/2008	2		PVT	PVT	NONE	NONE	NONE			1						1	Injection site erythema; Injection site pruritus; Injection site swelling	FLU3~SANOFI PASTEUR~U2810AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329793	10/23/2008	DC	49.0	49		F	10/23/2008	Swollen arm, pain, redness and induration on the site of injection (12 cm x 8 cm)									U	10/21/2008	10/21/2008	0		UNK	PUB			fluconazon, clindamycin			1						1	Injection site erythema; Injection site induration; Injection site pain; Oedema peripheral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA172AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0329794	10/23/2008	TX	1.0	1	.0	F	10/23/2008	For 7 nights following vaccination woke up screaming or wimpering. History of encephalitis as a new born									Y	09/12/2008	10/23/2008	41	None	PVT	PVT	Ciprodex otic drops	None	None			1						1	Crying; Screaming	FLU3~SANOFI PASTEUR~UT2782FA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB245AA~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0988X~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C45724E~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0975X~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0329795	10/23/2008	ME	65.0	65		F	10/23/2008	fever to 101  malaise 2 inches + erythema  and tenderness at site										10/20/2008	10/21/2008	1		PVT	PVT	cozaar  hctz  amitrytiline   lovastatin  ibuprofen	local leg pain only	htn   hamstring tendinitis  hyperlipidemia			1						1	Injection site erythema; Injection site pain; Malaise; Pyrexia	FLU3~SANOFI PASTEUR~u2772aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~09620~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329796	10/23/2008	AR	49.0	49		F	10/23/2008	pruritis, erythema at site									Y	10/10/2008	10/11/2008	1		PUB	PUB						1						1	Injection site erythema; Injection site pruritus	FLU3~SANOFI PASTEUR~u2807aa~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329798	10/23/2008	AZ	5.0	5		M	10/23/2008	02.40pm swelling of eyes and across nasal bridge, o2 at 10 liters via 100% rebreather pulse ox 96%, pulse 160-170,B.P 112/62, no respiratory distress lungs clear airway clear. Benadryl 12.5mg I.M., 911 called,2:45pm.2:50pm.EMS here, Epinepherine 1:1000 0.3ml given by EMS. 2:55 Pt. transported via ambulance to hospital.  10/24/2008 MR received for DOS 10/21-22/2008 with D/C DX:  Anaphylactic reaction 2' to Flu vaccine. Static encephalopathy.  G-tube dependent. Pt presented to ER from PCP's office where pt developed immediate facial, eye, tongue and body swelling, difficulty breathing and agitation.  Epipen and Benadryl given on site and transported via EMS. Tx with Solumedrol and admitted for observation. PE (+) for periorbital edema and tongue enlargement. Pt did well and didn't require O2. D/C home next day.					Y	1			Y	10/21/2008	10/21/2008	0		UNK	UNK	Depakene,Baclofen,Prevacid,Clonazepam,Lorazepam,Albuterol,Pulmicort	none	Cerebral Palsey,Seizures, Developmental Delayed, GERD. PMH: encephalopathy, seizure d/o, G-tube.  Egg allergy	Swelling of eyes and ears~Measles + Mumps + Rubella + Varicella (ProQuad)~2~4.20~In Patient		1						1	Eye swelling; Heart rate; Oxygen saturation; Swelling face	FLU3~SANOFI PASTEUR~U2750AA~5~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0329799	10/23/2008	IA	52.0	52		F	10/23/2008	Initial symptoms: dizziness, blurred vision, tightness in throat, near syncopal. Patient was seen in the emergency room and monitored.  Treatment included diphenhydramine 50 mg IM.				Y					Y	10/21/2008	10/21/2008	0	EKG and monitor of Blood Pressure and Heart Rate.	PVT	PVT		None	ALLERGIES TO SHAMPOOS, BODY CREAMS, NICKEL DYES			1						1	Dizziness; Electrocardiogram; Presyncope; Throat tightness; Vision blurred; Dizziness; Electrocardiogram; Presyncope; Throat tightness; Vision blurred	FLU3~SANOFI PASTEUR~U2766AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2766A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0329802	10/23/2008	CA	33.0	33		F	10/23/2008	Dizziness, blurred vision, throat tightening, chills, sweats - about 2-3 hours after the vaccination.  Treated in ER with Tylenol, Benadryl and observation.  Felt fairly severe flu like symptoms for next 24-36 hours				Y					Y	10/21/2008	10/21/2008	0		PVT	UNK	Prevacid	No	No			1						1	Chills; Dizziness; Hyperhidrosis; Influenza like illness; Throat tightness; Vision blurred	FLU3~CSL LIMITED~02649111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0329806	10/23/2008	VA	39.0	39		F	10/23/2008	C/O more intense burning at injection site at time of vaccine administration.  No bleeding observed, inj site re wiped with alcohol swab and Bandaide applied.  HA began 4 hrs after inj. R-sided migraine type with a little blurred vision and color aura (which is normal for this person when a migraine occurs).  Took 600 mg Ifuprofen at 4 pm.which is what she normally takes for HA.  Had slight injection site irritation and swelling that evening.  Removed bandaid and applied ice at 6 pm.  No further c/o or action taken that evening.  Tues 10/21/08 upon arising noted itching, redness, heat, swelling at the inj site.  HA continued.  Took Ifuprofen 600 mg at 6 am and 12 noon without relief for HA.  Purchased generic extra stringth Excedrin Migraine took two tablets at 5:30 pm.  Arm continued with burning, itching, redness and localized pain.  HA continued but was resolved by AM 10/22/08.  Arm symptoms continued 10/22 but no action taken.  10/23/08 contacted individual who administered immunization to report current symptoms of reddness, and itching. Seen by RN.  Noted 2.5 x 4.5 area of induration, warmth and firmness.  Skin color not changed.  Rec ice or heat for comfort, OTC cream/lotion for itching if needed.  See PMD if symptons worsen.  CDC/VEARS report completed.									U	10/20/2008	10/20/2008	0		UNK	UNK	Lisinioprl 10 mg daily began 10/6/08; Wellbutrin SR 150 mg 2 x daily		Allergies cat, Keflex,sulfa         Hypertension, Smoking cessation			1						1	Aura; Headache; Injection site erythema; Injection site induration; Injection site irritation; Injection site pruritus; Injection site swelling; Injection site warmth; Migraine; Vision blurred	FLU3~SANOFI PASTEUR~U2789BA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329809	10/23/2008	OK	55.0	55		F	10/23/2008	Flu Shot given at workplace at 9:30 am on 10/16/2008.  Fever beginning at 5:00 pm lasting until 10/19/08.  Hives beginning at 8:00 pm 10/16/08.  After calling Dr. on 10/17 patient began taking Benadryl and Zantac.  Worsening hives requires patient to go to the After Hours clinic on 10/20/08.  Shot of steroids was given and a prescription given for Prednisone 30 mg per day tapering dosage over next seven days. In addition take Zyrtec 1X day and Zantac 150 MG 2X day.  As of today's date condition is mildly improved.  History of sensitivity to sulfites, wonders if the vaccine contained sulfites used as a preservative.  Was hospitalized in 1993 for severe allergic reaction from flu vaccine but have taken numerous flu shots in following years with no problem.				Y					N	10/16/2008	10/16/2008	0		UNK	UNK	Zebeta 10 mg daily, claritin 10 mg daily and Singular 10 mg daily  Nasacort and Albuterol as needed.	None	Allergies  Sulfa Drugs, Naproxen  Sulfite Sensitivity (anaphalaxis)			1						1	Similar reaction on previous exposure to drug; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA156AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0329812	10/23/2008	IN	0.5	0	.5	M	10/23/2008	Infant developed frequent vomiting 10/21-22/08 overnight to the point of dehydration.  He also had some diarrheal stools.  He did not require IV fluids or hospitalization but responded to oral rehydration with Pedialyte.									Y	10/20/2008	10/21/2008	1		PVT	PVT		Slow weight gain, nasal congestion.	None			1						1	Dehydration; Diarrhoea; Vomiting	DTAPIPVHIB~SANOFI PASTEUR~C3176AA~1~IM~RL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~UT2782FA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0601X~1~IM~RL~HEP B (RECOMBIVAX HB)~1|PNC~PFIZER\WYETH~C71571~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0281X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0329813	10/23/2008	OH	45.0	45		F	10/23/2008	Woke up during the night of 10/8 with severe arm pain/ redness, swelling and lymph node tenderness.  Felt terrible.  Not sure which vaccination it was seeing the nurse gave them to me in the same arm.  I do know the 2nd one really hurt and I asked her which one that was and she replied, I don't know. Called doctor office on 10/9 and told RN who had administered the shots how I felt and was informed to give it a day or so.  That I wa having a mild reaction.  Although I knew better. Went home and checked temp. 101.  Went to bed.  Miserable night, much worse in morning. Went to urgent care at 8:00 am on 10/10.  Much closer to work, plus they opened at 8:00 am vs. waiting another hour (9:00 AM DR. office opens then)Saw dr. and was diagnosed with cellulitis.  temp 102.2 now. Was given an injection and two scripts.  One for Keflex and another for percocet. Dr. traced armed before I left around the red/swelling area.  Told to come back if it got worse.  Head and neck were killing me at this time. Called dr. at 1:00 pm on 10/10 and told him I was worse.  He told me to wait a couple of hours to give the meds a chance to kick in.  Left work at 3:10 pm and went back to urgent care. Took one look at my arm and told me I needed to be admitted to hospital.I was admitted on 10/10/08 with severe cellulitis and was discharged on 10/15/08 after 6 days of living hell. Had needle remove some of the infection. I sure would like someone to be responsible and reimburse me for my hospital stay, loss wages and ongoing dr. visit.  Today is 10/23/08 and my arm is still not back to normal!!! unfortunatly, all I have is the shots lot number.  There is nothing else indicated on my medical records which I received after I decided NEVER to return to family dr. again.  10/31/2008 MR received for DOS 10/10-15/2008 with D/C Dx: Cellulitis and abscess of upper arm and forearm.  Coronary atherosclerosis of native coronary vessel. Unspecified hyperlipidemia.  Essential hypertension, unspecified benign or malignant.  Unspecified chronic bronchitis. Pt presented with c/o of L upper arm pain radiating into the shoulder which began immediately after vaccines.  PE (+) for LUE swelling, warmth and tenderness. ID consult reports redness and fevers in addition to above with dx: severe cellulitis. Tx with abx			Y		Y	6			Y	10/08/2008	10/09/2008	1	Initial white blood count 24,000, dropped to 12,500 I believe on that Monday, 10/13.Hospital has the rest of all other tests. Labs and Diagnostics:  EKG abnormal with no-specific ST and T wave abnormalities.  CBC with WBC 24-86% neutros. K+ 3.4. ESR 49.  ASO (+). Blood cx (-). Wound aspirate cx (-). Gram stain with rare WBCs-no bacteria. CXR (+) for lingular pulmonary infiltrate.	UNK	UNK	Simvastatin 80 mg., Valtrex 1 gram, flax seed oil,multi-vitamin, Zovia birth control, potasium 5 pills a day,diaretic pill.	None.	Shingles. PMH:  Recent herpes zoster. Uterine fibroids, endometriosis, chronic bronchitis, CAD with palpitations, Hyperlipidemia, HTN, shoulder and foot surgeries. Allegies: codeine, prednisone, sulfa			1						1	Activities of daily living impaired; Body temperature increased; Erythema; Feeling abnormal; Headache; Immunisation reaction; Infection; Lymph node pain; Neck pain; Pain in extremity; White blood cell count increased	FLU3~SANOFI PASTEUR~U2770AA~3~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0619X~1~ID~LA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0329814	10/23/2008	IA	9.0	9		M	10/23/2008	6cm in diameter area of erythema and edema. Advised guardian to give benedryl.				Y					Y	10/20/2008	10/22/2008	2		PUB	PUB	Clonidine 0.1mg 1/2 tab BID, Concerta 18mg 1 tab daily	none	adhd			1						1	Erythema; Oedema	FLUN3~MEDIMMUNE VACCINES, INC.~500559P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~0989X~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0329815	10/23/2008	IL	3.0	3		F	10/23/2008	Mother called health dept. about child having elevated temp of 102 and uncontrollable shaking for 3-4 hours after receiving the flu shot on 10-22-08 . Took the child to the Dr. on 10-23-08 and Dr . instructed mom to not get the child the second flu shot this season since this was probably a reaction to the flu vaccine .				Y					Y	10/22/2008	10/22/2008	0		PUB	PUB			Has asthma .			1						1	Pyrexia; Tremor; Vaccination complication	FLU3~SANOFI PASTEUR~U2769AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329816	10/23/2008	AZ	49.0	49		F	10/23/2008	Cough, hoarseness, throat felt full, fever, eye mattering, mild wheezing.  Went to urgent care and then sent to ED where she received an SVN treatment.  Symptoms resolved by day after vaccination.				Y					Y	10/15/2008	10/15/2008	0		UNK	PVT	Aspirin 81 mg qd, beta blocker, microgestin Fe 120.	None	Irregular heartbeat, hypertension, allergic rhinitis and low grade chronic cough.			1						1	Cough; Dysphonia; Eye discharge; Pyrexia; Throat tightness; Wheezing	FLU3~SANOFI PASTEUR~U2740AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329818	10/23/2008	PA	10.0	10		F	10/23/2008	Pt had localized uticarial reaction at site of vaccine administration in right deltoid.				Y					Y	10/22/2008	10/23/2008	1		UNK	UNK	none	None	none			1						1	Injection site reaction; Injection site urticaria	FLU3~SANOFI PASTEUR~U2811AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0519x~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0329819	10/23/2008	MA	85.0	85		F	10/23/2008	Patient received a flu immunization intramuscularly in Left arm at public flu clinic on 10/22/08.  Reports severe increased swelling, redness and pain at site, requiring cold compresses and Acetaminophen									Y	10/22/2008	10/22/2008	0		PUB	PUB	unknown	no	no allergies, other medical conditions unknown			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA191AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0329821	10/23/2008	WV				M	10/23/2008	Patient received Anthrax vaccination on 10/04/2008 in the right deltoid area and within hours developed redness and swelling at the injection site which got worse, he did not experience any temperature elevations or drainage. He was admitted to into the hospital and was given Cipro and vancomycin.  It was not determined by the physician if this was an allergic process or an actual infection.					Y				Y					MIL	MIL		N/A				1						1	Injection site erythema; Injection site swelling	ANTH~EMERGENT BIOSOLUTIONS~FAV149~7+~SC~LA~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500557P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEP~MERCK & CO. INC.~AHBVB596CA~1~IM~RA~HEP B (FOREIGN)~1	USA	Hospitalisation	Influenza
0329822	10/23/2008	MS	21.0	21		M	10/23/2008	SEIZURE; TEMPERATURE OF 100.2 DEGREES F.				Y					Y	10/14/2008	10/16/2008	2		MIL	MIL	AUGMENTIN COMPLETED 10/13/08, AURALGAN EAR DROPS PRN, TYLENOL PRN, TRIHEXYPHENIDYL, COLACE, KEPPRA, KLONOPIN, TRAZODONE, MULTI VITAMIN	EAR INFECTION	HYPOXIC ENCEPHALOPATHY AFTER NONFATAL DROWNING; ANXIETY; HISTORY OF SEIZURES; IMPAIRED SLEEP; DYSKINETIC MOVEMENTS			1						1	Body temperature increased; Convulsion	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA181AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0329823	10/23/2008	MS	74.0	74		M	10/23/2008	ELEVATED TEMP 101.4 DEGREES F ON 10/14/08 AND 104.5 DEGREES F ON 10/15/08.  GIVEN TYLENOL AND MOTRIN. SENT TO EMERGENCY DEPARTMENT AND THEN ADMITTED TO HOSPITAL WHERE HE REMAINS AT TIME OF REPORT. 10/31/08-records received for DOS 10/16-10/26/08-DC DX: Acute encephalopathy secondary to acute viral meningoencephalitis. Acute renal failure secondary to ischemic acute tubular necrosis which resolved once the dehydration was corrected. Hypotension with ischemic hepatitis which subsequently trended down to normal. Rhabdomyolysis. New diagnosis of Parkinson's disease. Hypernatremia secondary to dehydration. New diagnosis of right lower extremity deep vein thrombosis. Systemic inflammatory reactive syndrome secondary to hypotension, fever. Admitted with fever, decreased mentation, tachycardia, blood pressure of 56/36.				Y	Y	9			U	10/14/2008	10/14/2008	0	10/31/08-records received-Viral panel negative. Blood culture and urine culture no growth. CT scan abdomen unremarkable. CSF protein 71, pleocytosis.	UNK	UNK	SEROQUEL, HALDOL PRN, MIRALAX, MULTIVITAMIN, ARICEPT, NAMENDA, PRILOSEC, ZOCOR, ASPIRIN, VIT B12 IM, TRAZODONE, PAXIL, PRIMIDONE, TYLENOL AND MOTRIN AS NEEDED.	HAD JUST FINISHED 7 DAY COURSE OF BACTRIM FOR CELLULITIS	ALZHEIMERS DEMENTIA W/BEHAVIOR DISTURBANCES, DUODENAL ULCER, CHRONIC SINUSITIS, HAND TREMORS, ANGINA, HYPERLIPIDEMIA, DEPRESSION, VIT B12 DEF. 10/31/08-records received- PMH: positive for Alzheimer's disease.			1						1	Body temperature increased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA174AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation	Influenza
0329824	10/23/2008	TX	58.0	58		F	10/23/2008	PATIENT HAD FLU SHOT AROUND 12:30PM. REMOVED BANDAID AROUND 8PM AND HAD NO APPARENT PROBLEM BUT SHORTLY THEREAFTER SHE EXPERIENCED ITCHING, PAIN, AND ARM WARM TO THE TOUCH. THEN SHE HAD REDNESS, SWELLING AND CHILLS,FEVER AND WEAKNESS. SHE SAID SHE HAD A ROUGH NIGHT AND IN THE MORNING HAD A RATHER LARGE RED AND SWOLLEN AREA IN THE DELTOID REGION, AND AROUND THE ARM AND AXILLA									U	10/04/2008	10/04/2008	0	PATIENT TOOK BENADRYL ORALLY AND PARACETAMOL SHE SAID SHE CONSULTED HER DOCTOR BY TELEPHONE AND WAS TOLD BY THAT DOCTOR  THAT HER BREATHING SOUNDED LABORED	UNK	UNK		NONE APPARENT AND NO SUCH INDICATION ON CONSENT FORM	ALLERGY TO  IODINE, TETANUS AND PENICILLIN, CONTRAST MEDIA, ONIONS AND GRAPEFRUIT BUT NONE WERE DOCUMENTED ON CONSENT FORM			1						1	Asthenia; Chills; Erythema; Pain; Pruritus; Pyrexia; Skin warm; Swelling	FLU3~SANOFI PASTEUR~U 2741 AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1381u~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329826	10/23/2008	WI	1.83	1	.9	F	10/23/2008	Hives around the injection site down R) leg and to her arms 24hrs after injection.									Y	10/22/2008	10/23/2008	1		PVT	PVT		None	None			1						1	Injection site urticaria	FLU3~SANOFI PASTEUR~UT2785CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329827	10/23/2008	AK	48.0	48		F	10/23/2008	5 hours after influenza vaccine, developed dry, hacky cough. Over the next hours, bilateral eye swelling with whitish, yellow drainage, erythemia and tenderness of chest wall and nipples, chills, swelling of tongue and gums. Felt like tongue was on fire. No SOB or wheezing. Took one Singulair tab. Sx mostly subsided over 24 hours.									Y	10/21/2008	10/21/2008	0		PVT	PVT	NONE	NONE	NONE - Many years ago had strong local reaction to flu shot with subsequent, sustained axillary node swelling. No flu shot for many years.	strong local reaction~Influenza (Seasonal) (no brand name)~UN~40.00~In Patient		1						1	Chills; Cough; Erythema; Eye discharge; Eye swelling; Gingival swelling; Glossodynia; Musculoskeletal chest pain; Swollen tongue	FLU3~SANOFI PASTEUR~U2831AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329830	10/23/2008	PA	2.0	0	.3	F	10/23/2008	Patient given Flumist on 10/1/08. No problems noted at time of administration. On 10/6/08 patient developed pruritic rash.  Seen in office on several occasions. Started Orapred on 10/10/08. Spoke with mother on 10/23/08 and child has urticara-free since 10/14/08.									Y	10/01/2006	10/06/2006	5		PVT	PVT						1						1	Rash pruritic; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500549P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0329831	10/23/2008	KY	29.0	29		F	10/23/2008	Headache,nausea,fever,chills, fatigue and severe back pain.				Y					Y	10/21/2008	10/22/2008	1		PUB	UNK	Zoloft, Zantac, Birth control, Multi vitamin.	P.M.S.	none			1						1	Back pain; Chills; Fatigue; Headache; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~2713111088~UNK~UN~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329832	10/23/2008	TX	36.0	36		F	10/23/2008	Employee received influenza vaccination in the dept she was assigned.  She stated that within approx. one hour she felt a sudden onset of heart racing and blurred & double vision.Her co-workers put her in a wheelchair, took her BP (152/98) and took her to the ER.  She was admitted & treated for allergic reaction to flu vaccination. Treatment: chest xray = normal; EKG = normal sinus rhythm.  Medications given to her were: Decadron 10mg IM; Benadryl 25mg PO x 1; Zantac 150mg PO x1; Ativan 1 mg PO x1. She was discharged @ approx. 4:30PM with prescriptions for Prednisone 20mg (to take 3 /day x 5 days); Xanax 0.25 mg (1 -2 q 8hrs for anxiety); & Bendaryl OTC.				Y					Y	10/23/2008	10/23/2008	0	Treatment: chest xray = normal; EKG = normal sinus rhythm.	PVT	PVT	daily Multi-Vitamin	none	none			1						1	Chest X-ray normal; Diplopia; Electrocardiogram normal; Hypersensitivity; Palpitations; Vision blurred	FLU3~CSL LIMITED~02649111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0329833	10/23/2008	OR	39.0	39		F	10/23/2008	Patient had Pneumovax and Flu shots at another facility on 10/20.  She had shooting pains in her legs and arms and weakness and lethargy later that evening and continuing through today.									U	10/20/2008	10/20/2008	0	CBC, CHem panel, ordered and pending	PUB	UNK	Diamox, aspirin		Hyperkalemic periodic paralysis			1						1	Asthenia; Full blood count; Laboratory test; Lethargy; Pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~unknown~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~unknown~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0329834	10/23/2008	CA	15.0	15		F	10/23/2008	PATIENT CAME IN WITH MOM AND SIB FOR FLU VACCINE, MOM STATED THAT THEY DID NOT WANT FLUMIST BECAUSE IT CAUSED AT BLOODY NOSE. HAD NEVER HAD A BLOODY NOSE BEFORE OR AFTER THE FLUMIST.									Y	10/18/2006	10/18/2006	0		UNK	PVT						1						1	Epistaxis	FLUN3~MEDIMMUNE VACCINES, INC.~500432P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0329835	10/23/2008	MT	71.0	71		F	10/23/2008	Nausea followed by syncope night of 10/20/2008 which resulted in a head injury requiring 8 stitches from ER. Had another severe dizzy spell with nausea and sweating morning of 10/22/08.  12/31/08 Reviewed ER records of 10/21/2008 & 10/22. FINAL DX: syncopal episode & scalp laceration closed w/8 staples.  Lightheaded & vertigo. Records reveal patient experienced nausea & when got up from bed to walk to bathroom fell hitting her head.  Minimal LOC.  D/C to home.  Returned to ER next day w/dizziness & vertigo.  Found to have orthostatic changes, UTI & dehydration.   Tx w/IV fluids & d/c to home on oral antibiotics.				Y	Y	1			Y	10/17/2008	10/20/2008	3	Blood pressure slightly low upon ER visit, patient did report that ER found blood in her urine and started her on ciprofloxacin for potential UTI on 10/22/08.  LABS: CBC, chemistry WNL, CPK & Troponin WNL.  LFT WNL.  UA w/protein & blood, leukocyte esterase, c/s contaminated.  EKG w/multiple PACs.  CT head WNL.	UNK	UNK	Alendronate 70mg once weekly; Lexapro 5mg once daily; Doxepin 10mg nightly;Fluocinonide 0.05% ointment 3 times daily;Bacitracin ophthalmic ointment twice daily	None reported	None known  PMH: viral illness, hematuria, asthma, depression.			1						1	Blood urine present; Dizziness; Head injury; Hyperhidrosis; Hypotension; Nausea; Suture insertion; Syncope	FLU3~SANOFI PASTEUR~U2742AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~1207X~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Hospitalisation	Influenza
0329836	10/23/2008	FL	34.0	34		F	10/23/2008	Systemic reaction: low-Grade fever, chills, severe muscle aches and splitting headache. Symptoms began just about 24 hrs after the vaccine.									Y	10/22/2008	10/23/2008	1		UNK	UNK						1						1	Chills; Headache; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~?~1~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329837	10/23/2008	AL	37.0	37		F	10/23/2008	severe pain on and around injection site. fever up to 101.4. muscle aches, stomach cramps, headache									U	10/22/2008	10/22/2008	0		PUB	UNK						1						1	Abdominal pain upper; Headache; Injection site pain; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~7+~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0329838	10/23/2008	TX	50.0	50		M	10/23/2008	symptoms: dizziness, weakness, headache, low-grade fever, neck sore, nasal/throat congestion                                  onset: 18 hrs after flu shot            duration: 48 hrs                                 treatment: none except rest                      recovery: complete									Y	10/19/2008	10/20/2008	1	none	UNK	UNK	none	allery drainage	none	nausea, vomiting, headache, joint aches~Influenza (Seasonal) (no brand name)~UN~10.00~In Patient		1						1	Asthenia; Dizziness; Headache; Nasal congestion; Neck pain; Pyrexia; Respiratory tract congestion	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA358AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0329840	10/23/2008	FL	51.0	51		M	10/23/2008	Patient started having chest pain and SOB 2 days after shot with severe swelling of (R) arm.  10/27/08 MR received for DOS 10/10-16/2008 with D/C DX: Acute Respiratory Failure. Severe Hypokalemia. Congestive Failure. COPD. Morbid Obesity. HTN. Sleep Apnea. Severe Degenerative Arthritis.  Pt presented after recent hospital d/c for sepsis, with c/o allergic rxn to Pneumovax received upon d/c. Pt developed SOB, wheezing, fever and redness and swelling of the arm. Noted to be hypokalemic on admission with bilateral wheeze and rhonchi. Tx with abx, steroids, and K+ with improved fever and SOB.				Y	Y	5			Y	10/08/2008	10/10/2008	2	Labs and Diagnsotics:  CXR (+) for cardiomegaly, vascular congestion, and interstitial edema. CK 265 with normal CKMB and Troponin. Na+ 141, K+ 2.5, BUN 20, creatinine 1.4.  WBCs 15.4 w/ 94% neut, 2% lymphs. ABGs abnormal. PT 26 on d/c with INR 2.56. Sputum cx and Gram stain (+) for MRSA.	OTH	PVT	Unknown	None	Unknown . PMH:  Morbid obesity-hx of Gastric Bypass, CHF, Pulmonary HTN, degenerative arthritis, severe sleep apnea, arthrodesis L hip. COPD, depression. NKDA.			1						1	Chest pain; Dyspnoea; Oedema peripheral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA154AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0224X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0329847	10/23/2008	IL	7.0	7		F	10/23/2008	Received FLUMIST on 08/25/2008. On 9/21/2008 was admitted to CMH with diagnosis ITP. Was told by specialists ITP caused by virus; per mom, only known before ITP was live FLUMIST.  11/12/08-records received for DOS 9/21-9/23/08-DC DX: ITP. Presented with petechial rash on shins bilaterally. Rash non=pruritic. Bruising later same day. Evening of admission developed raised erythematous lesion on tongue and corners of mouth. Treated with IVIG. Follow-up: As of 1/7/09 was to followup in hospital hematology clinic in 2-3 months. If counts normal then, would discharge from hematology as resolved. If counts still abnormal followup CBC's in office / clinic until resolved. Last platelets 153K (NL 150 - 450).					Y	2			U	08/25/2008	09/21/2008	27	Still undergoing RX with IVIG to increase plt count (between 4.000-26.000 since then)  11/12/08-record received- Platelets <5, WBC 3.52, hematocrit 33, neutrophils absolute 1.228.	PVT	PVT			11/12/08-records received-PMH:35 week twin, required 10-12 days intubation, jaundice.			1						1	Idiopathic thrombocytopenic purpura; Platelet count decreased; Blood product transfusion; Idiopathic thrombocytopenic purpura; Platelet count decreased	FLUN3~MEDIMMUNE VACCINES, INC.~500543P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500543P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Hospitalisation	Influenza
0329849	10/23/2008	IN	3.0			F		A serious, spontaneous report of seizure was received from a Physician concerning a three year-old female patient subsequent to FLUMIST.  The patient's past medical history includes seizures.  Concomitant therapy includes levetiracetam.  The patient received FLUMIST on 13-Oct-2008 at 9:30 am.  On 13-Oct-2008 at 2:30 pm the patient experienced a seizure.  The child was seen at the emergency room, where she was evaluated and released.  The child was also seen by a pediatrician on 14-Oct-2008.  The patient's office stated the seizures had been well controlled with levetiracetam and the patient had not suffered a seizure for about one year.  The outcome for the adverse events was not reported. Follow-up: Numerous follow up attempts have been made, no new information has been received.				Y					U	10/13/2008	10/13/2008	0		OTH	OTH	KEPPRA		The patient's past medical history includes seizures.		MEDI0007267	1						1	Condition aggravated; Convulsion	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0329852	10/23/2008	UT	1.0	1	.0	M	10/23/2008	About 6 hours after immunizations were given, he became very lethargic and almost unresponsive.  This lasted about 4 hours.  No seizure activity noted by mother, although patient has a history of meningitis at 4 months of age.  After about 4 hours, he was acting fine.  Is fine today.  (He has not had seizures after 5 months of age and is off sz meds).									Y	10/17/2008	10/17/2008	0		PVT	PVT	No	No	None			1						1	Depressed level of consciousness; Lethargy	FLU3~SANOFI PASTEUR~UT2782CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~UNKNOWN MANUFACTURER~0988X~1~SC~LL~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|PNC~PFIZER\WYETH~C46480~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0171X~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0329853	10/23/2008	UT	26.0	26		F	10/23/2008	Hives, facial swelling and chest tightness occurred within 24 hours.  Treated with Benadryl OTC at home and Benadryl 50mg IM at clinic.				Y					Y	10/22/2008	10/22/2008	0	None	OTH	PVT	None	None	None			1						1	Chest discomfort; Swelling face; Urticaria	FLU3~SANOFI PASTEUR~U2809AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329854	10/23/2008	OR	42.0	42		F	10/23/2008	Had flu vaccine about 0900. Went back to work area. Because increased SOB almost shivered. Realized things weren't right without 15 of injection. Used Albuterol inhaler. Stayed in work area till increased SOB x 2 about 12:00. Came back to RN work area. Sent to health clinic. Given PO BENDARYL. Coworker brought inhaler. Used 2nd time. Back to  baseline by 1300.									Y	10/22/2008	10/22/2008	0		OTH	OTH	WELLBUTRIN; CLARITIN; PROZAC; SYNTHROID; dust mite; dust; dogs; cats; fleas	baseline allergies	tetracyclines; CODEINE; Sulfa drugs			1						1	Chills; Dyspnoea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA159AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0329855	10/23/2008	CA	46.0	46		F	10/23/2008	Rash to lower arms, face and neck. Appear on the 17th. Today is 10-23-08 rash still over my lower arms.									N	10/16/2008	10/17/2008	1		PUB	OTH	None	None	None			1						1	Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA155AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0329856	10/23/2008	WI	69.0	69		F	10/23/2008	Developed raised red area around injection site 2 1/2 inches across with itching.  Told patient to use diphenhydramine orally and hydrocortisone topically and contact primary MD.									Y	10/21/2008	10/22/2008	1		OTH	PVT	Ranitidine; Oxybutinin; Lisinopril; Atenolol; Simvastatin					1						1	Injection site erythema; Injection site pruritus; Injection site swelling	FLU3~SANOFI PASTEUR~U2848AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329858	10/23/2008	WA	4.0	4		M	10/22/2008	Tactile fever, vomiting x 7.										10/21/2008	10/22/2008	1		PVT	UNK	Zyrtec; Singular	None	None			1						1	Pyrexia; Vomiting; Pyrexia; Vomiting	DTAP~SANOFI PASTEUR~C2955BA~5~IM~RL~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500567P~1~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~A0492~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0812X~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0989X~2~SC~RL~VARICELLA (VARIVAX)~1|DTAP~SANOFI PASTEUR~C2955BA~5~IM~RL~DTAP (DAPTACEL)~2|FLUN3~MEDIMMUNE VACCINES, INC.~500567P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|IPV~SANOFI PASTEUR~A04922~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~2|MMR~MERCK & CO. INC.~~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~2|VARCEL~MERCK & CO. INC.~0989X~2~SC~RL~VARICELLA (VARIVAX)~2	USA		Influenza
0329859	10/23/2008	NY	32.0	32		F	10/23/2008	Patient reports that, within 10 minutes after receiving Flu vaccine her left thumb had became swollen, hardened to touch and had sharp cramping / pulsation which lasted approx. 10 minutes - then changed to a subtle discomfort and resolved completely within one hour.									Y	10/23/2008	10/23/2008	0		OTH	OTH	None	None	None	None~ ()~~0.00~In Patient		1						1	Muscle spasms; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8788202~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0329860	10/23/2008	IA		87		M	10/22/2008	On 10-12-08 pt noticed pain and bruising on her Lt upper arm. Each day the bruise get bigger and it is almost to the elbow area. The bruise is very dark in color. Seen Dr on 10-21-08. No treatment ordered.				Y					N	10/10/2008	10/12/2008	2		PUB	PVT	antibiotic; PRN BP med.	None				1						1	Contusion; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~AFLLA191AA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0329861	10/23/2008	NY	70.0	70		F	10/23/2008	Redness, swelling, warmth treated with MEDROL dose pack and cold compress				Y						10/20/2008	10/22/2008	2	None	PVT	PUB	Numerous	None	HTN; GERD; ANEMIA			1						1	Erythema; Skin warm; Swelling	FLUX~UNKNOWN MANUFACTURER~AFFLA193AA~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0619X~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0329863	10/23/2008	ND	67.0	67		F	10/23/2008	About 10 minutes after receiving vaccine, pt felt tingling in tongue and felt swelling - was gone in 45-60 minutes so pt felt was her imagination - felt pain in shoulder on eve after shot the next day the arm was more painful and hurts in to left neck still painful today - No sign of problem @ injection site.				Y					U	10/21/2008	10/21/2008	0		PVT	PVT	triamterene; HCTZ; Levothyroxine; Lisinopril; calcium; aspirin		seizure with baby shots so never completed series			1						1	Musculoskeletal pain; Neck pain; Pain in extremity; Paraesthesia oral; Swollen tongue	FLU3~SANOFI PASTEUR~U2789CA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~1214X~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0329870	10/23/2008	WV	64.0	64		M		Pt presently in hospital diagnosed with Guillain Barre after given flu vaccination. Hospital called for this office to report flu vaccine to CDC. 12/29/08-records received for DOS 10/18-10/25/08 and 10/31-11/10/08-DX GBS-Leucopenia. Presented on 11/17/08 with slurred speech and right LE weakness and numbness and gait disturbance. Subsequent admission on 10/31/08-presented with weakness and cyanosis, abdominal discomfort. treated with IVIG. Bilateral facial palsy. Mid to moderate oral dysphagia.Subsequent admission for fever and flank pain.					Y	19			U	10/02/2008	10/18/2008	16	12/29/08-records received-Chest x-ray atelectasis. Blood cultures negative. UGI endoscopy and HIDA scan normal.  CT scan kidneys and pelvis fatty infiltration of liver otherwise unremarkable. Barium swallow improved from previous swallow of 10/21/08 with regards to oral manipulation of food consistencies. CSF protein 242.	PVT	OTH			Hypertension; IBS; Gout; O.A; Depression; GERD 12/29/08-records received- PMH: GERD, HTN, BPH, Anxiety, prostatitis, Dupuytren's contracture of hand			1						1	Guillain-Barre syndrome	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA155AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0329872	10/23/2008	WI	1.3	1	.3	M	10/23/2008	Tdap (BOOSTRIX) administered instead of DTaP.									Y	10/08/2008	10/08/2008	0		PVT	PUB						1						1	Wrong drug administered	FLU3~SANOFI PASTEUR~U2828AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B018BA~1~IM~LL~TDAP (BOOSTRIX)~1	USA		Influenza
0329873	10/23/2008	IA	44.0	44		F	10/23/2008	10/20/08 1650 Flu vaccine given to patient.  10/21/08 called to report went to ER by 1830 10/20 due to dizziness, shortness of breath, vomiting and rapid heart rate.  Arm swollen and tender.  IV fluid given discharged by 2130.				Y					Y	10/20/2008	10/20/2008	0		OTH	OTH		None reported				1						1	Dizziness; Dyspnoea; Heart rate increased; Oedema peripheral; Tenderness; Vomiting	FLU3~CSL LIMITED~02449111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0329874	10/23/2008	CO	37.0	37		F	10/22/2008	Vaccine app 10AM, Oct 1, 2008. Thurs. aching all over (arms and legs, not head). Nausea, upset stomach.  Rash on arms, legs, maculopapular, face and chest for 3 weeks started Friday. Fever (no thermometer used) but no chills. No redness or swelling at injection site.									Y	10/01/2008	10/10/2008	9	None	PUB	PVT	THYROID SYNTHROID 0.88	None	hypothyroidism			1						1	Nausea; Pain; Pyrexia; Rash; Rash maculo-papular; Stomach discomfort	FLU3~SANOFI PASTEUR~U2768AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329877	10/23/2008	OH	29.0	29		F	10/21/2008	Patient received vaccine on 10/20/08.  Several hours later she was aware of severe itching in mouth and over entire body.  No visible rash, hives or skin disorders noted.  Returned to work on 10/21/08 and informed medical staff and was offered referral to Emergency Room.  Patient refused treatment.  RN noted no rash, hives, or skin disorders educated patient on signs/symptoms of anaphylactic shock.  Instructed to go to ER if symptoms persist or worsen.									N	10/20/2008	10/20/2008	0		UNK	UNK	None	None	Bactrim allergy			1						1	Oral pruritus; Pruritus generalised; Oral pruritus; Pruritus generalised	FLU3~CSL LIMITED~03549111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|FLU3~CSL LIMITED~03549111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~2	USA		Influenza
0329879	10/23/2008	NH	80.0	80		F	10/20/2008	10 x 12 cm fluctuant swelling, pain, tenderness deltoid muscle, Fever.										10/10/2008	10/11/2008	1	None	PVT	OTH		Hypertension	GERD, Osteoarthritis, Osteoporosis, Cataracts, Allergic to Sulfa, Ceftin			1						1	Pain; Pyrexia; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U2743AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0328432	10/24/2008	PA	20.0	20		M	10/24/2008	Pt had SVP #1, AVA #1, typhoid #1 and FLUMIST on 30 Sep 08. On 10/13/08 pt noted pimple like, itchy rash on right forearm which spread to his right forearm. On 10/14/08 when he went for his second AVA he reported the rash to the staff in Immunization clinic and was reassured that it was nothing to worry about. About 4 hours later the pt noted increase rash on both forearms which had also spread to his stomach/chest, back and legs. On 10/15 he noted the rash on his face. He was transferred on 10/17 and was discharged on 10/18/08. As of 10/24 the pt states that the rash is 80% improved.					Y	1			U	09/30/2008	10/13/2008	13	Reference Test Site / Specimen 16 Oct 2008 1626 units Ref Rng. Material / Source, Punch Biopsy of left arm  12/1/08-records received-pathology report 11/4/08-right upper arm biopsy. DX: subactue spongiotic dermatitis.	UNK	UNK	None	None	None			1						2	Rash papular; Biopsy skin; Dermatitis; Rash generalised; Rash papular; Rash pruritic; Vaccine positive rechallenge	ANTH~EMERGENT BIOSOLUTIONS~FAV149~1~SC~RA~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~5005522P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TYP~SANOFI PASTEUR~A09233~UNK~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|ANTH~UNKNOWN MANUFACTURER~~UNK~SC~UN~ANTHRAX (NO BRAND NAME)~2|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|SMALL~UNKNOWN MANUFACTURER~~UNK~~UN~SMALLPOX (NO BRAND NAME)~2|TYP~UNKNOWN MANUFACTURER~~UNK~UN~UN~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0329400	10/24/2008	AL	69.0	69		F	10/24/2008	Pt. called on 10/202008 and reported rash with itching several hours after vaccine given. Treated at emergency room, given a steroid shot and rx for atarax.				Y					Y	10/17/2008	10/17/2008	0		PUB	PUB		none	unknown		AL0828	1						2	Urticaria; Pruritus; Rash; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA364AA~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA364AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~2|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA364AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~3	USA	Emergency room visit	Influenza
0329875	10/24/2008	MN	53.0	53		F	10/23/2008	Received flu vaccine at around 11:15 am. Started having difficulty breathing, poor color. Was given 0.3 mL Epinephrine @ 11:51 am. B/P 142/78 P - 90. She appeared to improve slightly; was taken to E.R. for further eval				Y					Y	10/22/2008	10/22/2008	0		OTH	UNK	METFORMIN;Hydrochlorothiazide;LEXAPRO; LAMICTAL;SYMBICORT; Albuterol; SONATA; XANAX;SIMVASTATIN	Asthma, Diabetic, High Blood Pressure				1						1	Dyspnoea; Pallor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA173AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0329876	10/24/2008	MA	21.0	21		F	10/22/2008	Local Reaction at injection site, redness, swelling 10-17-08. Left eye blurred vision 10-22-08.									Y	10/17/2008				PVT	UNK	None	None	None			1						1	Injection site erythema; Injection site reaction; Injection site swelling; Vision blurred	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~892973P~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0329903	10/24/2008	CA	1.0	1	.0	M	10/24/2008	Febrile seizure				Y					Y	10/13/2008	10/22/2008	9	CBC	PVT	PVT	None	None	None			1						1	Febrile convulsion; Full blood count	FLU3~SANOFI PASTEUR~UT2785CA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0285U~1~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C46480~4~UN~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0103X~1~UN~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0329904	10/24/2008	PA	43.0	43		F	10/22/2008	5 hours after vaccine had uncontrollable chills.  Temp was 103 7-8 hrs after vaccine.  1 hour after taking Motrin 600 mg had localized soreness 3 hours afterwards.  The next day, felt better - feel she has low grade fever (approximately 99-100).  No other sxs.  Fever up to 101 the following evening.									Y	10/22/2008	10/22/2008	0		UNK	PVT	TOPROL; Flecainide	None	Frequent PVCs			1						1	Chills; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2789EA~3~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329905	10/24/2008	CT		50		M	10/24/2008	Sore, weak, small rash in back spread to side, stomach. Blister on same arm as injection; popped it later 07 - Rash has worsened over days. Right now feels shortness of breath. Has doctor appointment at 3 pm. Took ADVIL for soreness but did not help.									U	10/20/2008	10/21/2008	1		OTH	PUB						1						1	Asthenia; Blister; Dyspnoea; Pain; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329906	10/24/2008	VT	79.0	79		F	10/21/2008	Per pt began as intense itching 2 days after w/ progressive redness to site. Seen today by MD - dx'd w/ allergic urticaria redness  decreased to 3 area below deltoid and itching gone.									U	10/15/2008	10/17/2008	2		PVT	PUB	None	None	Herpes zoster			1						1	Hypersensitivity; Injection site erythema; Injection site pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA207AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|TDAP~SANOFI PASTEUR~C2938AA~UNK~UN~LA~TDAP (ADACEL)~1	USA		Influenza
0329907	10/24/2008	AZ	9.0	9		F	10/20/2008	Few hours after vaccines, developed malaise - then had syncopal episode, collapsed to ground, then had seizure - was shaking x few seconds.				Y					Y	10/13/2008	10/14/2008	1	None	PVT	UNK		Mononucleosis	None			1						1	Convulsion; Fall; Malaise; Syncope; Tremor	FLU3~SANOFI PASTEUR~U2806AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0570X~1~UN~RA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0329908	10/24/2008	AZ	17.0	17		F	10/20/2008	Pt fainted and was advised to go to Emergency Room.				Y					Y	10/20/2008	10/20/2008	0		PVT	PVT						1						1	Syncope	FLU3~SANOFI PASTEUR~U2746AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329909	10/24/2008	GA	2.0	1	1	F	10/21/2008	The evening after receiving vaccines, patient cried for 4 hrs and was possibly hallucinating.									Y	10/14/2008	10/14/2008	0	None	PVT	OTH		None	None			1						1	Crying; Hallucination	FLU3~SANOFI PASTEUR~U2771AA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB289AA~2~UN~LL~HEP A (HAVRIX)~1	USA		Influenza
0329910	10/24/2008	WI	74.0	74		M	10/20/2008	Per patient rigors, chills, and lips turned blue x 1hr.  Did not seek medical attention.									Y	10/06/2008	10/06/2008	0		PUB	UNK						1						1	Chills; Cyanosis	FLU3~SANOFI PASTEUR~U2770AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0047X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329912	10/24/2008	MA	68.0	68		F	10/20/2008	Patient developed redness, swelling and warmth to Right upper arm, resolved on its own.									Y	09/29/2008	10/01/2008	2		PVT	OTH	PRILOSEC; Glipizide; LASIX; Aspirin; Atenolol; Simvastatin; Glucophage; enalapril		DM II; Hyperlipoproteinemia; HTN, GERD			1						1	Erythema; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U2746AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0990U~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329913	10/24/2008	MA	68.0	68		F	10/20/2008	Patient developed redness, swelling, warmth, and tenderness to right upper arm, approximately measuring 3 x 5, treated with KEFLEX for ? cellulitis.									Y	10/16/2008	10/17/2008	1		PVT	OTH	atenolol; PROVACHOL		hypercholesterolemia; DM II; Paroxysmal atrial tachycardia			1						1	Erythema; Oedema peripheral; Skin warm; Tenderness	FLU3~SANOFI PASTEUR~U2829AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1541U~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329915	10/24/2008	CT		68		F	10/21/2008	Fever of 100 P.O - 8-9 hours following vaccine. Chills.									Y	10/12/2008	10/12/2008	0		OTH	OTH						1						1	Chills; Pyrexia	FLU3~SANOFI PASTEUR~U2751AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329916	10/24/2008	MD	60.0	60		M	10/23/2008	Had vaccination 10/21/08 in PM. Early AM 10/22 noted redness, itch and induration about injection site. Seen and Rxd BENADRYL PO. Yesterday PM. Last noc. patient's wife outlined about a 15-16 cm oval area of redness. Today it is about 8 x 10 cm with associated induration as well as central vesiculation both linear and grouped. Symptomatically also somewhat improved. No evidence infection/cellulitis. No fever/chills. Will continue BENADRYL (none so far today - 10/23/8) 25 - 50 every 6 hours PO PRN. No prior Hx reactions.									Y	10/21/2008	10/22/2008	1		OTH	OTH	None	None; history of Rimura's disease	See # 18 -			1						1	Injection site erythema; Injection site induration; Injection site pruritus; Injection site vesicles	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89738~7+~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0329917	10/24/2008	MD	65.0	65		M	10/24/2008	Has hives.  Rash began yesterday (10/23/08) approximately 8 PM ie approximately 7 hrs after flu vaccine given.  Has normal gross vital signs and upper - lower respiratory tract exam.  Begun on Benadryl 250 PO this AM (10/24/08).									Y	10/23/2008	10/23/2008	0	None	UNK	UNK						1						1	Rash; Urticaria; X-ray with contrast lower gastrointestinal tract	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89738~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0329922	10/24/2008	WI	38.0	38		M	10/20/2008	Left upper extremity cellulitis (pain and swelling in his left deltoid area with lymphadenopathy under his arm). Required antibiotic therapy.  10/29/2008 MR received for ER visit 10/08/08 with DX: L arm Cellulitis, Pneumonia, Fever and DOS 10/10-11/2008 with D/C DX: Allergic Reaction to Flu and Pneumonia shot.  Probable Cellulitis, L arm.  Non-ischemic cardiomyopathy.  Bronchial asthma.  Depression.  Anxiety.  HTN.  Hyperlipidemia.  Chronic shoulder pain. Pt presented to ER 10/08/08 with c/o pain, redness and swelling in the L deltoid/triceps/axilla, mild cough with increased wheeezing and H/A.  PE(+) for 14x10cm area of irregular erythema, swelling and marked tenderness. Tx with pain meds, nebs and steroids. Returned 10/10/08 with worening sx including fever and nausea. Injection site itching and painful, with tightness noted near the elbow.. TX with keflex and Prednisone with improvement.					Y	1			Y	10/07/2008	10/08/2008	1	CT Scan of (L) Upper extremity. Labs and Diagnostics:  CT scan arm c/w cellulitis.CXR (+) for LLL opacity c/w atelectasis vs infiltrate. WBC 12.8-81% Neut, 11% Lymphs	PUB	UNK		None	H Failure. mem  PMH:  Adjustment Deficit D/O. Chronic Shoulder Pain.  Cardiomyopathy.  RAD. Depression.  Anxiety. HTN. Hyperlipidemia.			1						1	Cellulitis; Lymphadenopathy; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2770AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0870X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0329924	10/24/2008	OH	23.0	23		F	10/24/2008	Severe headache, chest pain and SOB, scratchy eyes the afternoon and evening after receiving the vaccine at ~noon.									Y	10/15/2008	10/15/2008	0		PVT	PVT	Zoloft, Lo-estrin	No	No			1						1	Chest pain; Dyspnoea; Eye pruritus; Headache	FLU3~SANOFI PASTEUR~U2832AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329925	10/24/2008	CO	41.0	41		F	10/24/2008	Pt felt no pain at the time of the vaccine administration, but felt pain 2/10 at rest, increasing to 8/10 with palpation, within 2-3 hours after administration.  Deep bruising noticed within 2-3 hours after administration, that is still visible today, 8 days later.  The arm is still tender on palpation.									Y	10/16/2008	10/16/2008	0		PVT	UNK	Excedrine taken October 12, 2008.	None	NKA			1						1	Contusion; Pain	FLU3~CSL LIMITED~02649111A~7+~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0329926	10/24/2008	PA	37.0	37		F	10/24/2008	ON 10-21-08 AT 1100 RECEIVED VACCINE 1115 COMPLAINT OF FEELING DRUNK AND THEN TOOK BENADRYL 25MG AND CALLED MEDICAL  ARRIVED IN MEDICAL AT 1130 COMPLAINING OF METALLIC TASTE IN MOUTH AND FEELING LIKE SHE DRANK A 6 PACK OF BEER AND HAVING NUMBNESS AND TINGLING IN HANDS COMPLAINED OF THROAT CLOSING AND CHEST TIGHTNESS VITALS 100/70-96-22 AND PULSE OX ON ROOM 99% EPINEPHRINE 1/1000 0.3MG WAS ADMINISTERED, AMBULANCE CALLED, NO SOB AND NO HIVES, OXYGEN APPLIED TRANSPORTED TO ALTOONA HOSPITAL ER. I SPOKE WITH EMPLOYEE TODAY AND SHE SAID THAT SHE RECEIVED BENADRYL IM IN AMBULANCE AND AFTER ARRIVEING IN ER SHE DEVELOPED A HEADACHE AND BEGAN TO ITCH ALL OVER BUT NO RASH OR HIVES DEVELOPED. SHE SAID SHE RECEVED A STEROID INJECTION IN THE ER AND WAS FINALLY RELEASED FORM THE ER AT 1615. SHE WAS PRESCRIBED STEROIDS X 7 DAYS AND BENADRYL PRN FOR TICHING.  SHE IS STILL COMPLAINING OF A HEADACHE AND ITCHING AND FEELS SOME CHEST TIGHTNESS WHICH SHE ATTRIBUTES TO THE RAPID LABORED BREATHING THAT SHE SAYS SHE DEVELOPED AFTER THE ADMINISTRATION OF THE EPINEPHRINE.				Y					Y	10/21/2008	10/21/2008	0		UNK	UNK	VITAMINS	NO	PCN, COMPAZINE, X-RAY DYE			1						1	Chest discomfort; Dysgeusia; Dyspnoea; Feeling drunk; Headache; Hypoaesthesia; Paraesthesia; Pruritus generalised; Throat tightness; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88805~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0329927	10/24/2008	MI	65.0	65		F	10/24/2008	Received PPV23 (SC) and TIV (IM) into left arm 10-21-98.  The patient called the office on 10-23-08 to report that her left arm  was red, hot, swollen with  pain and pressure from the elbow to the arm pit.  She relayed that the site was better on the 23rd than the 22nd.  A status call on 10-24-08 indicated that she had inproved since the 23rd and that she did not report that she was  nauseated with the other symptoms also.									Y	10/21/2008	10/22/2008	1		PVT	PVT	Levothyroxine, Budeprion, Actonel, Glucosamine Chondroitin, Antivert, Tessalon Perles, Calcium, multi-vitamin, Fish oil, Ambien	Healthy	Codeine			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFILLA158AA~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1960U~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329928	10/24/2008	MI	1.0	1	.0	F	10/24/2008	MMR vaccine administered on 10/13/08.  Fever 101.7 beginning 10/19/08. Runny nose 10/22/08-present.  Rash on trunk, face, back and arms beginning 10/23/08. Decreased apppetite and increased fussiness 10/23/08.				Y					U	10/13/2008	10/19/2008	6	none	PVT	PUB	Zantac 15mg/ml 1 1/3ml BID prn	none	Reflux 4/08, NKDA			1						1	Decreased appetite; Irritability; Pyrexia; Rash; Rhinorrhoea	FLU3~SANOFI PASTEUR~UT2788FA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0215X~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C40033~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0791X~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0329929	10/24/2008	NC	60.0	60		M	10/24/2008	Within an hour after receiving the shot at 12:17 P.M. on October 11, 2008, I began to feel as though something was wrong. I continued to get more physically uncomfortable for the next 36 hours. By Monday morning the 13th I felt as though I had a mild case of the flu, but went to work anyway. By Tuesday morning the 14th, I was too ill with flu-like symptoms to go to work and stayed home. Wednesday morning the 15th, I went to work again, but was still ill. I feel as though I had a low-grade flu the rest of that week. Between the weekend (October 18) thru today's date (October 24), I continue to have bad cold symptoms including sinus, congestion, and coughing problems, but the flu symptoms are gone.									Y	10/11/2008	10/11/2008	0	N/A	UNK	UNK	Zocore (everyday), Zomig (as needed), and asprin (everyday).	None	Sulfa allergy	None~ ()~~0.00~Patient		1						1	Cough; Influenza like illness; Nasopharyngitis; Sinus congestion	FLU3~SANOFI PASTEUR~U2771AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329932	10/24/2008	AZ	65.0	65		M	10/24/2008	Fever and body aches for 48 hours.  Pain, swelling, heat and redness of deltoid area, gravitating distally to elbow, one week until resolution.									Y	10/02/2008	10/03/2008	1		PUB	PUB	None	None	None			1						1	Erythema; Oedema peripheral; Pain; Pain in extremity; Pyrexia; Skin warm	FLU3~SANOFI PASTEUR~U2786CA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0519X~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329933	10/24/2008	SD	2.0	2	.9	M	10/24/2008	Client received intramuscular injection of 0.25 ml Fluzone influenza vaccine at 1145. Client observed his mother receiving flu vaccination at 1157. Client laid down on clinic floor. Nurse completed the mother's vaccination and immediately attended to client who appeared to have a vasovagal reaction. Clerical was directed to call 9-1-1, related to client's father's history of reactions to immunizations; though client had received two doses of influenza vaccine in the previous flu season. Oxygen was administered in a blow-by fashion while pulse and blood pressure were taken. Client began arousing at 1158, skin was cold and clammy. When emergency personnel arrived at 1200 client was alert and oriented, though continued to be lethargic. When client's father arrived at 1202 client was alert and oriented X3 and greeted father with a smile. Apical pulse at 1201 was 114 beats per minute. Blood pressure using pediatric cuff was 84/50 and pulse was 120 beats per minute. By 1207 client was talking clearly and walking steady. Emergency personnel and nurse concurred that patient experienced syncopy and did not need to be transferred to hospital. At 1230 client went home with mother and father, smiling and talking as they went.									Y	10/17/2008	10/17/2008	0	None performed.	PUB	PUB	None	None	None			1						1	Cold sweat; Lethargy; Oxygen supplementation; Syncope vasovagal	FLU3~SANOFI PASTEUR~UT2782EA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329934	10/24/2008	MA	35.0	35		F	10/24/2008	Wheezing, gasping for air.  Went to local Emergency Room and treated with IV Prednisone and nebulizer treatment				Y					Y	10/23/2008	10/23/2008	0	None done	PUB	PVT	None	None	Penicillin	None~ ()~NULL~~In Patient|None~ ()~NULL~~In Sibling1		1						1	Dyspnoea; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA172AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0329935	10/24/2008	FL	61.0	60		F	10/24/2008	7 min. after flu shot was given, c/o feeling bad.  Heart rate-76/minand regular, respirations 16/min and regular.  C/o slight tightness in her throat.  At 10:00 a.m., c/o increased throat tightening.  Resp-16/min and regular, pulse-76 and reg.  No shortness of breath noted.  Color pink, skin warm and dry.  Taken to ER by government vehicle, accompanied by 2 fellow employees.				Y					Y	10/23/2008	10/23/2008	0	Hostroy of asthma	UNK	PUB			Allergic to septra.  History of asthma.			1						1	Asthma; Dry skin; Feeling abnormal; Skin warm; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA172AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0329937	10/24/2008	GA	61.0	61		F	10/24/2008	CLIENT COMPLAINED OF PAIN AT INJECTION SITE SOON AFTER INJECTION.  CLIENT STATED THAT LATER IN THE EVENING HER LEFT ARM BEGAN SWELLING, TURNING RED AND WAS PAINFUL TO MOVE.  CLIENT STATES THAT SHE TOOK BENADRYL TO RELIEVE SWELLING AND IRRITATION AND TYLENOL FOR PAIN.  THE NEXT MORNING, CLIENT STATES THAT THE SWELLING AND REDNESS WAS BETTER, BUT IT WAS STILL PAINFUL.  CLIENT WAS INSTRUCTED TO CONTINUE TAKING TYLENOL AND BENADRYL FOR PAIN AND IRRITATION AND TO CALL HER DOCTOR IF IT DID NOT GET ANY BETTER OR IF IT GOT WORSE.									Y	10/23/2008	10/23/2008	0		PUB	PVT						1						1	Erythema; Injection site pain; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~2765AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0813X~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329938	10/24/2008	CA	11.0	11		M	10/24/2008	tingling and weakness in lower legs and feet 2 days after receiving MCV, Tdap, INF (nasal) and VZV.  11/14/08 Reviewed PCP medical records or 10/3-11/3/08. FINAL DX: none provided Records reveal patient in usual state of good health on day of vaccination. Seen in ER 10/23 w/numbness feet & legs & had low grade fever.  No treatment provided, observation.				Y					U	10/21/2008	10/23/2008	2	None at this time  LABS: CBC WNL.	UNK	UNK		None	Tourette's syndrome  PMH: groin pain, tics, foot planus.  Allergy: sulfa, rash.			1						1	Muscular weakness; Paraesthesia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~~UNK~~~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~~UNK~~~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~~UNK~~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0329939	10/24/2008	AL	51.0	51		F	10/24/2008	Very high fever, shaking chills, muscle aches, began at about 12 hours after the flu vaccine, left exhausted and debilitated the next two days.  Missed two days of work.  Never happened previously									Y	10/21/2008	10/21/2008	0		PUB	PUB	5 mg Lexapro	none	none			1						1	Asthenia; Chills; Fatigue; Impaired work ability; Myalgia; No reaction on previous exposure to drug; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329941	10/24/2008	MI	39.0	39		F	10/24/2008	Pt was given TIV fku vaccine 10-3-08.That night she had chest pain, dyspnea,dysphagia.  Went to ER and was given breathing treatment,IV's and injections.In ER again with heart pounding dysphagia and dyspnea on 10-06-08.  Okay after breathing treatment.  Sent home with epi pen and albuterol inhaler.  Office visit 10-17-08 pt doing well.  She was instructed to continue with prednisone tapering dose.  Also given Rx for benadryl and cimetidine.  She is instructed to not have the flu vaccine again and to follow in office prn.				Y					Y	10/03/2008	10/03/2008	0		PVT	PVT		no	keflex, iodine, tetanus, CT dye	arm swells~Td Adsorbed (no brand name)~UN~~In Patient		1						1	Chest pain; Dysphagia; Dyspnoea; Palpitations	FLU3~SANOFI PASTEUR~u2744aa~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329942	10/24/2008	PA	37.0	37		F	10/24/2008	Breaking out in rash on both arms from sholder and down entire arm.  Taking benedryl for treatment.									U	10/22/2008	10/23/2008	1		UNK	UNK				Rash and itching~ ()~NULL~~In Patient		1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329943	10/24/2008	IL	13.0	13		M	10/24/2008	PATIENT RECEIVED FLUMIST ON 10/13/2008.  DEVELOPED FACIAL NERVE PALSY (BELL'S PALSY) ON 10/21/2008.  12/2/08 Reviewed PCP medical records of 10/4-10/13/08. FINAL DX: none provided Records reveal pt seen 10/4 for removal of sutures from right leg laceration.  Received flumist on 10/13.  1/21/09 Reviewed PCP medical record of 10/22/08. FINAL DX: Bell's palsy Records reveal patient experienced right facial paresis, unable to completely close right eye, eye watery. Tx w/eye protection, no meds.				Y					U	10/13/2008	10/21/2008	8	NORMAL CBC AND ESR.  LYME DISEASE TITER PENDING. PATIENT DENIES ANY VIRAL ILLNESSES IN RECENT PAST.	UNK	UNK	FLONASE NASAL SPRAY, ZYRTEC TABLET	NONE	ALLERGIC RHINITIS, NO ASTHMA.			1						1	Facial palsy; Full blood count normal; Red blood cell sedimentation rate normal	FLUN3~MEDIMMUNE VACCINES, INC.~500567P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0329944	10/24/2008	PA	60.0	60		F	10/24/2008	Eight hours after I had my flu vaccine, I developed diarrehea followed by vomiting for the next 18 hours.  The last vomit was entirely blood.  I fainted and was transported to Mt Nittany Medical Center's ER where I recieved 3000cc of glucose solution, was tested negative for common intestinal deseases and bleeding.  the next two days I followed a clear liquid diet until I met with Kartrana Lutz, PA who advised me to resume eating a regular diet and return for a CBC in a week to be sure I am in good health again.				Y					Y	10/16/2008	10/16/2008	0	Stool was negative for parasights and blood.  CBC was with in normal range.  Blood Potassium was low.	PVT	PVT		Hypertension, GURG, RSD left leg and foot	None			1						1	Blood potassium decreased; Diarrhoea; Full blood count normal; Haematemesis; Occult blood negative; Stool analysis normal; Syncope; Vomiting	FLU3~SANOFI PASTEUR~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329945	10/24/2008	OH	23.0	23		M	10/24/2008	Headaches - until 2 days after vaccination - Tx = Acetaminophen, Blood Shot Eyes - until 5 days after vaccination - Tx = Visine, Naphcon-A, Chest Congestion - until 2 days after vaccination - Tx = DayQuil									Y	10/15/2008	10/15/2008	0	Self diagnosis - Pharmacy student	PUB	UNK	None	None	None			1						1	Headache; Ocular hyperaemia; Upper respiratory tract congestion	FLU3~SANOFI PASTEUR~U2832AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329947	10/24/2008	UT	49.0	48		F	10/24/2008	IW states she rcvd flu shot at 2300ish.  She developed a hard knot at injection site.   At 0100 she states she had pain that went into her shoulder and neck.   At 0300 she began itcing around shoulder, neck and injection site.   At 0330 she noticed hives.  She had an ER doc she was working with look at it and he suggested Benadryl.   At 0430 she took some Benadryl (25 mg).  The hives went away but the itching continued.   At 0900 itching and hives were gone but knot was still there. At 2049 the next night she still had a small knot, but itching, redness, heat, and hives were gone.  No medical treatment required.									Y	10/16/2008	10/16/2008	0	None.	PUB	UNK						1						1	Erythema; Injection site induration; Injection site nodule; Injection site pruritus; Musculoskeletal pain; Neck pain; Skin warm; Urticaria	FLU3~SANOFI PASTEUR~u2676aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329948	10/24/2008	GA	73.0	73		F	10/24/2008	Vaccine administered about 10am  on 11/20/2008. Itching,redness commenced in pubic area, inner thighs, around waist and under arms about 9pm.  Took 25mg  benadryl and repeated about 11pm.  Also applied 2.5% hydrocortisone ointment to red areas. Took benadryl once again about 8am. Itching occured again about 6pm.  By the time I had access to benedryl and hydrocortisone ointment at 7pm, the areas affected were much larger including a good portion of my back and around my bra line.  Repeated medications about 9:30pm and once again at 8am.  At this time I am waiting to see if this reoccurs late this afternoon/evening.										10/20/2008	10/20/2008	0		PUB	UNK			Sulfa drugs			1						1	Erythema; Pruritus	FLU3~CSL LIMITED~~UNK~~~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0329950	10/24/2008	AZ	48.0	47		F	10/24/2008	Dry,itchy throat, congestion, cough, chills									Y	10/15/2008	10/15/2008	0		UNK	UNK	BCP, nortryptilline, metoprolol	None	Migraines, hypertension			1						1	Chills; Cough; Dry throat; Respiratory tract congestion; Throat irritation	FLU3~SANOFI PASTEUR~U2740AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329951	10/24/2008	UT	49.0	49		F	10/24/2008	Received flu shot at 1540 and began itching all over body, mostly in ear canals and eyes.									Y	10/08/2008	10/08/2008	0	None.	PUB	UNK	unknown.	No,.	unknown.			1						1	Eye pruritus; Pruritus generalised	FLU3~SANOFI PASTEUR~U2767AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329952	10/24/2008	KS	57.0	57		F	10/24/2008	Four hours after receiving my drive up flu vaccine, I had fever, chills, dizziness, runny nose, cough, raspy throat and diahhria.  I self-medicated with Immodium, benedryl, aspirin and cough drops.  My cough developed first.  When I called the Public Health Dep't, they said cough was not related to the vaccine.  I did not call back once the other symptoms set in.  As to the manufacturer of the vaccine, I don't know it.									Y	10/23/2008	10/23/2008	0		PUB	PVT			Seasonal (Fall) allergies			1						1	Chills; Cough; Diarrhoea; Dizziness; Pyrexia; Rhinorrhoea; Throat irritation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329955	10/24/2008	AZ	59.0	59		F	10/24/2008	Mild arm soreness followed by generalized aching, unable to catch full breath, fever.  Had mild achiness day following vaccine.									Y	10/15/2008	10/16/2008	1		UNK	PVT	Zetia, actinal, ibuprofen, low dose ASA	None	Scleroderma, high cholesterol			1						1	Dyspnoea; Pain; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U2740AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329956	10/24/2008	WA	57.0	57		F	10/24/2008	Shot receive 11:40. 15:40 coughing, white of eye turning red.  18:40 white of eyes very red, difficulty breathing, skin in pain 22:30 body in a lot of pain.  Felt like an ice pick stabbing mid section all over 03:20 heart reacting, chest tightening, felt like the ice pick was stabbing the heart and felt very cold, terrible headache, face swollen, top of head itching, sinus area full of pressure 06:20 symptoms starting to go away 13:00 still had headache but able to breath better and feel recovery coming 18:00 able to consume food, 10/23 & 10/24 able to attend to business but feel tired and like my organs and muscles have been through a spin cycle.									Y	10/21/2008	10/21/2008	0		UNK	PVT			asthma			1						1	Chest discomfort; Cough; Dyspnoea; Fatigue; Feeling cold; Headache; Ocular hyperaemia; Pain; Palpitations; Pruritus; Sinus headache; Swelling face	FLU3~SANOFI PASTEUR~U2750AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329958	10/24/2008	PA	39.0	39		F	10/24/2008	Vaccine admninsitered at 1604 on 10/22/08 and individual began with nausea, fever ( 101) , chills, diarrhea, generalized body aches.  Symptoms lasted through 1600 on 10/23/08									Y	10/22/2008	10/22/2008	0	none	UNK	PUB	Migrestene ( bith control)	none	none			1						1	Chills; Diarrhoea; Nausea; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA209AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0329959	10/24/2008	NJ	9.0	9		M	10/24/2008	2 1/2 hours after the flu mist was given my son broken out in a severe rash on this legs and feet. I called the covering doctor and was told it is totally unrelated.  I gave my son benadryl and put 1% hydrocortisone cream all over his rash.  In the morning it has spread to his buttocks and his arms. I took him back to the doctor who told me it may or may not be a reaction to the flu mist. I was told to purchase Clarinex and 1% hydrocortisone ointment and it would take about a week to clear up.				Y					U	10/23/2008	10/23/2008	0		UNK	UNK		None				1						1	Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0329960	10/24/2008	MO	62.0	62		F	10/24/2008	10/22/08 6:30PM c/o eyes itching & burning and hoarse voice 10/23/08 4:30AM c/o headache got up to medication for headache, c/o nausea, became sweaty and skin felt clammy then passed out Reported did not seek medical attention.									Y	10/22/2008	10/22/2008	0		PUB	PVT	Cozaar, allergy serum, Neurontin	None	environmental allergies, hypertension, nerve pain			1						1	Cold sweat; Dysphonia; Eye burns; Eye pruritus; Headache; Hyperhidrosis; Loss of consciousness; Nausea	FLU3~SANOFI PASTEUR~U2810AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329961	10/24/2008	OH	30.0	30		F	10/24/2008	within 24 hours had diarrhea, vomiting, and chills lasting approx. 24 hours.									Y	10/15/2008	10/16/2008	1		PUB	PVT	none	none	none			1						1	Chills; Diarrhoea; Vomiting	FLU3~SANOFI PASTEUR~U2768AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329962	10/24/2008	MA		69		M	10/24/2008	Developed itching and hive-like rash 24 hours after receiving flu shot at public  clinic         Taking Benedryl PO every 4-8 hrs with relief       Referred to primary MD				Y					Y	10/22/2008	10/23/2008	1		PUB	PUB						1						1	Pruritus; Rash; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLA191AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0329963	10/24/2008	MN	28.0	28		F	10/24/2008	6 hours after administration of vaccine, developed fever (101F), severe chills, aches, headache, weakness, exhaustion, and loss of appetite.  Symptoms lasted for 60 hours.									Y	10/21/2008	10/21/2008	0		UNK	UNK	Celexa, birth control	None	Allergy to sulfa drugs	Fever, aches, headache~Influenza (Seasonal) (no brand name)~1~26.80~In Patient		1						1	Anorexia; Asthenia; Chills; Fatigue; Headache; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~UNKNOWN~7+~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329964	10/24/2008	SC	65.0	65		F	10/24/2008	patient came to clinic second day after vaccination. stated upper right arm swollen and itchy day before. at visit arm was no longer red and swollen but had a purplish discoloration at elbow,only slightly tender.									Y	10/14/2008	10/15/2008	1		PVT	PVT						1						1	Erythema; Oedema peripheral; Pruritus; Skin discolouration; Tenderness	FLU3~SANOFI PASTEUR~u2744aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0991u~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0329965	10/24/2008	OH	36.0	36		M	10/24/2008	diarrhea, vomiting, chills, fever of 103 degrees F.  Went to ER for IV fluids and antipyretic.				Y					Y	10/15/2008	10/17/2008	2		PUB	PVT	allergy injection every 3 months	none	allergies to pollen			1						1	Chills; Diarrhoea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2768AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329967	10/24/2008	MN	54.0	54		F	10/24/2008	Within a couple hours aches, fever rose to 101.5 within first 12 hours.  Came down below 100 within 24 hours with no other symptoms. Used Tylonal as treatment									Y	10/21/2008	10/21/2008	0		UNK	UNK	None	None	None			1						1	Pyrexia	FLU3~SANOFI PASTEUR~U2806AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329968	10/24/2008	PA	87.0	87		F	10/24/2008	Resident was given Afluria 0.5ml Im at 11am on 10/22/08.  At 9:05PM on 10/22/08, resident was observed with grand mal seizure activity. Resident was transferred to Saint Luke's Hospital in Bethlehem, Pa where she was admitted with a diagnosis of seizures.  The resident did not have a history or diagnosis of seizures prior to this event.  12/5/08 Reviewed hospital medical records of 10/22-10/31/2008. FINAL DX: status epilipticus w/prolonged encephalopathy. Records reveal nursing home patient experienced seizures x 2 with the last one lasting approx 40 min.  Lethargic, unresponsive & respiratory distress.  Intubated overnight & loaded w/antiseizure meds.  Neuro consult done.  D/C back to nursing home on pureed diet w/assist.  Coumadin d/c due to falls risk & tx w/ASA.				Y	Y	9			U	10/22/2008	10/22/2008	0	LABS: EEG x 2 abnormal showing diffuse cortical dysfunction.  CT head WNL.  MRI/MRA brain revealed no acute process & advanced microangiopathy.	UNK	UNK	aricept 10mg hs, docusate sodium 100mg bid, isosorbide mn 30mg hs, metoprolol 50mg q 12 hrs, multivitamin od, pantoprazole sod 40mg od, senna-gen 1 tab bid, seroquel 50mg hs,sertraline hcl 50mg od, warfarin sodium 3mg od	none	TIA, CAD, HTN,DJD, Hyperlipidemia, depression, gerd, diverticulosis, legally blind,   chronic afib, chronic insomnia, dementia, MI (03), hx of diptheria, scarlet fever, measles, mumps, chicken pox  PMH: seizure disorder, suspect secondary to prior stroke; right MCA stroke in past; atrial fib w/chronic anticoagulation; dementia; legally blind; OA; polymyalgia rheumatica; depression, CAD w/stent placement.  Allergy: codeine.			1						1	Convulsion; Grand mal convulsion	FLU3~CSL LIMITED~02449111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Hospitalisation	Influenza
0329970	10/24/2008	NY	30.0	30		F	10/24/2008	Patient experienced pneumonia-like sypmtoms and swelling on the arm of the injection site. She also had a fever.				Y					Y	10/10/2008	10/10/2008	0		PUB	PUB	UNKNOWN	UNKNOWN	UNKNOWN			1						1	Injection site swelling; Pneumonia; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA364AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~UNKNOWN MANUFACTURER~0860U~2~IM~UN~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0329973	10/24/2008	WA	47.0	47		F	10/24/2008	Approx 26hrs after dose administered in L deltoid, pt developed red, itchy swollen area medial aspect of L elbow.  Pt developed angioedema of lips 30hrs after dose os vaccine.  Pt treated with diphenhydramine and hydroxyzine after E.R. visit.				Y					U	10/21/2008	10/22/2008	1	None to date	PUB	PUB		None	Sulfa allergy			1						1	Angioedema; Erythema; Pruritus; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~GSKAFLUA366BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0329974	10/24/2008	CO	9.0	9		M	10/24/2008	PATIENT WAS WOOZY AND FEINTED APPROXIMATELY 30 MINUTES AFTER ADMINISTRATION OF FLU SHOT.  PATIENT REPORTED SPOTS IN HIS VISION, TINGLY FINGERS, AND DIZZY FEELING.  PATIENT DID NOT LOSE CONSCIOUSNESS.  PATIENT WAS NOT TREATED BY US--911 WAS CALLED, PARAMEDICS GAVE OXYGEN AND TOOK HIM TO ER FOR OBSERVATION.				Y					U	10/24/2008	10/24/2008	0	UNKNOWN	UNK	UNK	UNKNOWN	NONE OBSERVED	UNKNOWN			1						1	Dizziness; Paraesthesia; Syncope; Visual impairment	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89124~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0329976	10/24/2008	SC	59.0	59		F	10/24/2008	At 12:10 PM th patient reported back to the area where the flu clinic was being held compalaining of throat being scratchy and eyes sandy.  Her eyes were totally injected and her BP was 180/102.  She was given Benedryl 25 mg po and monitored for 1 hour.  Her BP went down to 146/70.  She was sent to her primary care physician who put her on a medrol dose pack.									Y	10/23/2008	10/23/2008	0		UNK	PUB						1						1	Blood pressure increased; Eye irritation; Ocular hyperaemia; Throat irritation	FLU3~SANOFI PASTEUR~U2793DA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329977	10/24/2008	KY	43.0	43		F	10/24/2008	Chest Pain, PND, cough, itchy eyes Benadryl 25 mg feeling better (less cough) 1 hr after benadryl. Has Epi pen will call if used.									Y	10/24/2008	10/24/2008	0	none	UNK	PVT	Pepcid	cold temp 98.8	Iodine and fish, marine extract, sea salt			1						1	Chest pain; Cough; Eye pruritus; Postnasal drip	FLU3~SANOFI PASTEUR~U2797AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329978	10/24/2008	TX	43.0	43		F	10/24/2008	The patient reports that a couple of minutes after receiving the shot her left shoulder/arm was very painful.  This pain has remained excruciating when her arm is in motion after two weeks, although it is not as painful when not in motion as it was initially.  There was not a local reaction noted at the site of injection.  The patient saw the physician's assistant at her regular physician's office on October 16, 2008, ten days after the shot, and she was prescribed Mobic/Meloxicam for the pain, which does help.  She has had an xray subsequently, but does not have the result.  She may be referred to an orthopedic specialist if the pain continues to bother her.  She states that she has not previously had problems with flu shots.				Y					N	10/06/2008	10/06/2008	0	Xray done week of 10/20/08, results not known.	UNK	PVT		None				1						1	Injected limb mobility decreased; Musculoskeletal pain; No reaction on previous exposure to drug; Pain in extremity; X-ray	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA184AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0329979	10/24/2008	VA	42.0	42		F	10/24/2008	Fever of 103 degrees, severe weakness and body aches approximately four hours after receiving the inactivated influenza vaccine.  Took two Tylenol PMs and went to bed.  Woke up the next morning with no signs of illness.  Called physician's office and was told that it was couldn't be a reaction to the flu shot.  I was told that my white blood count on that day was normal, but that maybe something was coming on when I received the shot. I replied that by the next morning, I was perfectly fine.  They then told me, Well, maybe you just shouldn't get the shot, then. I have Multiple Sclerosis, and I am advised by my neurologist to get the shot!  No effort was made to make a report, therefore I am doing it myself...  (after getting online and finding the vaccine information paper from the CDC website.) I was reading the CDC information page on the influeza vaccine again, and I noticed that hoarseness was also a potential reaction. I have been very hoarse since the shot, but, at first thought it was due to the weather. However, even when I drink something hot, the hoarseness does not go away, as normal hoarseness usually does. So, I would like to add this to my report. I received the vaccination last Tuesday, and I have been hoarse since.  When can I expec t this to stop? Are the reaction sI experienced from the shot considered an allergy to it? With Multiple Sclerosis, I am supposed to be vaccinated every year, because contracting influenza can be extremely harmful to me. Would this reaction make me unable to be vaccinated, or do the benefits outweigh the risks? (I can handle fever the night of the shot because I can take medication  to alleviate the discomfort and lower the fever, and the hoarseness is only a minor nuisance.) Please respond, because I have four school-aged children who frequently bring illnesses home from school, and I feel more protected being immunized. If I should avoid the flu shot, is there another vaccination I could take that would offer me protection from the flu that is perhaps made up of different components than the one I have been receiving? Any information and advice would be most appreciated. Thank you!									Y	10/21/2008	10/21/2008	0		UNK	UNK	Betaseron Injections every other day for MS.  Benicar for blood pressure.	No illness before, no illness after reaction resolved.	Allergic to codeine.  Have Multiple Sclerosis and take medication to control blood pressure (has been controlled now for at least six months).			1						1	Asthenia; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~??~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329981	10/24/2008	TN	55.0	55		F	10/24/2008	Flu shot @ 4:00 - Coughing at 7:00 - difficulty breathing 7:45 - hoarseness, hives, weakness, dizziness, lips and  gums stinging - lips, eyes swollen				Y					Y	10/22/2008	10/23/2008	1		PUB	PVT	Hydrocortisone, Florinef, Synthroid, Premarin, Prevacid		Addison's Disease  - Possible yellow food dye			1						1	Asthenia; Cough; Dizziness; Dysphonia; Dyspnoea; Eye swelling; Lip swelling; Pain; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0329984	10/24/2008	CA	62.0	62		M	10/24/2008	Eccymosis to Left forearm/upper arm, approx 3 inches below site of vaccine administration.  Noted 24 hours after vaccine was given.  CBC was drawn that was within normal limits.									Y	10/21/2008	10/22/2008	1	cbc	PUB	UNK	Norvasc, Lisinopril, lexapro, ASA, Glucophage, Lipitor, Zetia,	no	HTN, Hyperlipidemia, Insulin resistence			1						1	Ecchymosis; Full blood count normal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89977~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0329985	10/24/2008	CA	35.0	35		F	10/24/2008	Developed itching, rash, facial redness, throat swelling, rhinorrhea, nasal congestion, chills and malaise starting approximately 10 minutes after intramuscular influenza vaccine--FluZone				Y					Y	10/23/2008	10/23/2008	0		UNK	UNK	Zyrtec, multivitamin (without gelatin)	None	Allergy to gelatin, PCN.  Yellow #5 not confirmed.	Anaphylaxis~Measles + Mumps + Rubella (no brand name)~~17.00~Patient		1						1	Chills; Erythema; Immediate post-injection reaction; Malaise; Nasal congestion; Pharyngeal oedema; Pruritus; Rash; Rhinorrhoea	FLU3~SANOFI PASTEUR~U2752AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0329986	10/24/2008	KY	43.0	43		M	10/24/2008	Flu shot administered in the AM on 10/24/2006 at NIOSH by the facility nurse. Around 2:30 pm patient felt light headed, tightness in chest, sore ribs, lymph node soreness, stiffness in neck, tightness of throat and headache. As of 7:20 PM patient is lying down and still complaining of chest tightness. States does not feel well at all.										10/24/2008	10/24/2008	0		UNK	UNK	N/A	N/A				1						1	Chest discomfort; Dizziness; Headache; Lymph node pain; Malaise; Musculoskeletal chest pain; Musculoskeletal stiffness; Throat tightness	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329987	10/24/2008	AZ	39.0	39		F	10/24/2008	Heaviness in injection arm one hour after vaccine followed by cough, swelling and itching eyes, eye redness and discharge, fever, fatigue, head pressure.									Y	10/15/2008	10/15/2008	0		UNK	PVT	None	None	None			1						1	Cough; Eye discharge; Eye pruritus; Eye swelling; Fatigue; Headache; Ocular hyperaemia; Pyrexia; Sensation of heaviness	FLU3~SANOFI PASTEUR~U2740AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329988	10/24/2008	TX	47.0	44		F	10/24/2008	Severe,debilitating pain in arm that received injection.  Pain concentrated in neck and down arm ending just below elbow joint.  Treated with heat and Vicodin (Ibuprophen offered no pain relief).  Pain still mild/moderate at time of submission of this report (9 hrs post injection)									Y	10/24/2008	10/24/2008	0		UNK	PVT						1						1	Neck pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330009	10/24/2008	NC	33.0			F	10/15/2008	A serious report of supraventricular ventricular tachycardia (SVT) with heart rate greater than 160 has been received from a Registered Nurse and an office manager concerning a 33-year-old female employee in a pediatric office subsequent to FLUMIST. Medical history included tachycardia. The patient was not on any concomitant medications. The patient received FLUMIST, intranasal administration as an influenza vaccine at 11:00am at work on 09-Oct-2008. At approximately 4:00pm on the same day, the patient started having a very fast heart rate. She was transported to the emergency room (ER). While in the ER, her heart rate increased as high as 250 beats per minute (bpm). An electrocardiogram confirmed SVT, a chest X-ray was negative and unspecified lab work was done and all results were within normal limits. The patient was treated with unspecified intravenous medication to decrease her heart rate. The patient was discharged from the ER at around 9:00pm. The outcome of the SVT was unknown. The sponsor considered the SVT to be serious (important medical event).				Y					U	10/09/2008	10/09/2008	0		PVT	PVT	Concomitant Drug(s) Not Used	Tachycardia			MEDI0007276	1						1	Chest X-ray normal; Condition aggravated; Electrocardiogram abnormal; Heart rate increased; Laboratory test normal; Supraventricular tachycardia	FLUN3~MEDIMMUNE VACCINES, INC.~500544P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0330010	10/24/2008	OH	48.0	48		F	10/24/2008	After receiving influenza - FLUZONE vaccine for 1st time pt. was asked to remain in area x 15 min, after approximately 15 min pt. reported tingling of lips and some thickening in the throat. Heart Rate was Normal. No outward symptoms, no visual swelling, no clammy skin. Pt reported no difficulty breathing or swallowing. Pt. refused epinephrine and EMS. Pt. requested husband to pick her up. Pt instructed by RN to monitor symptoms. Pt. left clinic not in distress approx 1/2 hr after injection. Pt. to seek emergency care if worsening of symptoms. Pt verbalized understanding.										10/24/2008	10/24/2008	0	None known	PUB	PUB	none known	None specified	various medication allergies per pt.			1						1	Paraesthesia oral; Throat tightness	FLU3~SANOFI PASTEUR~U2768AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330011	10/24/2008	IN	62.0	62		M	10/24/2008	Patient developed hypotension x 1 day along with 2 day h/o myalgias, lightheadedness, subjective fever, and increased diarrhea.				Y					Y	10/16/2008	10/17/2008	1	None	OTH	OTH		Crohn's disease	Crohn's disease; bipolar disorder			1						1	Condition aggravated; Diarrhoea; Dizziness; Hypotension; Myalgia; Pyrexia	FLU3~CSL LIMITED~~UNK~~~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0330012	10/24/2008	IA	10.0	10		M	10/24/2008	Mom called RN @ about 1210 to report that started complaining of being light headed about bedtime and again this morning.									U	10/23/2008	10/23/2008	0		PUB	PVT		None	benign heart defect		IA08014	1						1	Dizziness	FLUN3~MEDIMMUNE VACCINES, INC.~500545P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0330013	10/24/2008	GA	4.0	4		F	10/23/2008	Had vaccine on Oct 21. On Oct 22 patient complained of pain and swelling. On Oct 23 there was a 3 inch area of redness, heat, swelling below the vaccine site.				Y					Y	10/21/2008	10/23/2008	2		PVT	PVT	No	No	No			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2745AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330014	10/24/2008	CA	59.0	59		F	10/24/2008	10/23 member started with warm hands and itching all over approx 1 Hr after Flu vaccine, took BENADRYL. Then about 10  AM 10/24 tongue swells				Y					Y	10/23/2008	10/23/2008	0		PVT	PVT		None	Dermatitis, Bronchitis, HTN, Hyperlipids			1						1	Feeling hot; Pruritus generalised; Swollen tongue	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA349AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0330015	10/24/2008	CA	9.0	9		F	10/24/2008	Numbness of hands, feet, distal extremities LUE 1st, then all 4. As of 10/24 all but LUE recovered. Grip weak LUE.  11/4/08 Reviewed ER medical records of 10/12/08. FINAL DX: extremity numbness of unknown etiology Records reveal patient experienced inability to feel legs/arms.  Walked into ER.      11/4/08 Reviewed PCP medical records of 10/15-10/24/2008. FINAL DX: transient numbness of extremities, improving.  High suspicion of reaction to flumist. Records reveal patient experienced numbness & had been seen in ER.  Feeling better but still numb in distal extremities, fall while running in school, dropping things, anorexic for a few days, 8# weight loss, diarrhea that had resolved.  Exam revealed slight decreased grip strength on left, decreased sensation from knees down & from elbows down,  areflexia in UE's.  RTC 10/24 improved but with left arm numbness persisting, difficulty writing, occasional HA, palpitations, SOB.				Y					N	10/02/2008	10/12/2008	10	CT Brain, CBC, CMP  LABS: AST 43(H), ALT 73(H), c-peptide 3.9(H). WBC 11.1(H), plts 404(H), neutros 34.6%(L), lymphs 56.7%(H), monos 4.9%(H).  Chemistry, EKG WNL.   CT head,  US & CT of abdomen/pelvis neg.  MRI back WNL.	OTH	OTH	None	None Known	Chemically elevated transaminases - Obese  PMH: abdominal pain, obesity, LFTs elevated, Hepatitis antibodies neg,			1						1	Grip strength decreased; Hypoaesthesia	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0330016	10/24/2008	ID	1.3	1	.3	M	10/24/2008	About 3 min. after vaccines given, pt. vomited and hive noted to (L) thigh under MMR injection site. No resp. distress. BENADRYL given as ordered (12.5 mg po). Pt observed 20 min, no distress, no further hives.									Y	10/24/2008	10/24/2008	0	None	PVT	UNK		None	None	None~ ()~~0.00~In Patient		1						1	Injection site urticaria; Vomiting	FLU3~SANOFI PASTEUR~UI2782FA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~UNKNOWN MANUFACTURER~0489U~1~SC~LL~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1	USA		Influenza
0330017	10/24/2008	TX	62.0	62		F	10/24/2008	Red, swollen face, eyes, fingers next day after vaccination - given BENADRYL EVERY 6 hrs				Y					Y	10/22/2008	10/23/2008	1		OTH	PVT	KENALOG, RELAFEN	Lupus	Penicillin, Sulfa			1						1	Erythema; Eye swelling; Oedema peripheral; Swelling face	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0330018	10/24/2008	MT	76.0	76		M	10/24/2008	Right arm extremely painful. Extreme pain in joint and deltoid. No redness or swelling.									Y	10/20/2008	10/21/2008	1	None	PVT	UNK		Cough, Felt feverish	Childhood Asthma			1						1	Arthralgia; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA367CA~5~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0224X~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330019	10/24/2008	GA	58.0	58		F	10/23/2008	Pruritis at the injection site at 5:15 p.m. - put Eucerin Calming once - no relief - intense redness and swelling at injection site. About 3 cm - talked with doctor and told to use Zyrtec and hydrocortisone and have Albuterol inhaler on hand - at 6:00 pm, felt dizzy and didn't feel so good barely made it to  e chair and passed out for about 20 seconds - pulse 6, B/P 135/95 - recovered. Speech was slow - went home after 30 minutes with my husband - took Zyrtec - used HC on injection site - on 10-11-08, the injection site was about 5 cm and very sore and hot to the touch. By 10-12-08, the swelling had decreased and redness had decreased.				Y					Y	10/10/2008	10/10/2008	0		PVT	PVT		None				1						1	Dizziness; Injection site erythema; Injection site pain; Injection site pruritus; Injection site swelling; Injection site warmth; Loss of consciousness; Malaise; Speech disorder	FLU3~SANOFI PASTEUR~U2810AA~7+~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330020	10/24/2008	NJ	7.0	7		M	10/23/2008	(+) erythema, (+) swelling, mild tenderness to site									U	10/22/2008	10/23/2008	1		PVT	UNK		Cough				1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U275UAA~4~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330021	10/24/2008	PA	5.0	5		M	10/25/2008	Had flu vaccine in right arm 10/23/08, 10/24 noticed redness -> pinpoint eccynosis at site of injection, no erythema in immediate area but diffuse confluent mild erythema/ warmth/ fullness around sides and back of entire upper arm. No induration, noi tenderness.									U	10/23/2008	10/24/2008	1		PVT	UNK	ALBUTEROL, PULMICORT, > PRN	None	Asthma			1						1	Injection site erythema; Injection site haemorrhage; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2805AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB259AA~2~IM~LA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1155~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0330022	10/24/2008	MO	50.0	50		F	10/25/2008	Pt called 10/21/08, states received Flu vaccine at 10:12 AM (Never had one before), approx. 2 1/2 hr after received, developed a cough, throat felt tight, HA, chills and vomited. Lasted several hrs no intervention.  Much better today. Stayed hm from work 10/21/08 - but still some residual									Y	10/20/2008	10/20/2008	0		OTH	OTH	ESTROPIPATE 0.7MG		None			1						1	Activities of daily living impaired; Chills; Cough; Headache; Throat tightness; Vomiting	FLU3~SANOFI PASTEUR~U2803AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330029	10/24/2008	CA	49.0	49		F	10/15/2008	Approximately 6-7 hours after influenza shot, patient described sensation of warmth all over body, rash on arms, legs, abdomen, and back, itchiness, and slight tightening in the throat. Patient was given BENADRYL 50mg po x1 on 9/3/08 PM. Symptoms had completely resolved by the following morning (9/24/08). Follow up 09/23/2008: Influenza vaccine given. Patient has received the influenza vaccine 0.5 ml IM at this encounter, from a multi-dose vial. The patient was also provided a copy of the CDC influenza immunization information sheet, dated 07/24/08. Patient denies any previous adverse reaction to influenza vaccine. Denies allergy to eggs or fever. Potential side effects of site tenderness, fever, chills, and muscle aches for first 48 hours explained. Special precautions of rare fatal reactions, hypersensitivity and Guillan-Barre Syndrome explained. Patient instructed to call with any problems.									Y	09/23/2008	09/23/2008	0		UNK	UNK						1						1	Feeling hot; Rash; Throat irritation; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA184AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330032	10/24/2008	CA	87.0	87		M	10/17/2008	Friday 10/10/2008: Patient was in good shape when I took him to MD - for a review of his blood test results.  He was advised to get a flu shot.  They were available in the lobby with a paper from the Dr.  He got the flu vaccines shot.  Saturday 10/11/2008: He sounds as if he has a hard time breathing. -7 P.M. - Saturday 10/11/2008: Patient goes to hospital via ambulance.  911.  Sunday 10/12/2008: Patient called me to advise me that he is in the hospital.  Monday 10/13/2008: I visit patient in hospital and he is non-responsive and barely alive.  Monday 10/13/2008: Patient died from pneumonia.  Prior to the flu vaccine he was in good health.  I believe the vaccine should not have been advised as it killed him. 10/28/08 Death certificate states COD as respiratory failure w/pneumonia & myelodysplasia as contributing causes.  10/28/08 Reviewed hospital medical records of 10/12-10/13/2008. FINAL DX: CHF; A-fib w/RVR; acute respiratory failure; acute exacerbation of COPD; acute exacerbation of chronic renal insufficiency & failure; malnutrition. Records reveal patient experienced SOB, bilateral leg edema, atrial fibrillation w/rapid ventricular response.  Cardioverted & admitted to ICU.  Developed acute respiratory failure, agitation, confusion worsened & placed on BiPAP.  Tx w/IV antibiotics.  Pt was DNR, no intubation.  11/25/08 Reviewed PCP medical records  Office record of 8/20/08 reveals pt disoriented s/p ER visit for visual disturbance, HA & temporal arteritis.  Had been started on steroids.  RTC 9/19/08 s/p ER visit after fall w/o sequelae.  RTC 9/29 w/fatigue.  RTC 10/10 stating felt better.  No record of flu shot, was given by unknown company in lobby of physician office building.	Y	10/13/2008							N	10/10/2008	10/10/2008	0	LABS: ESR peak 137 down to 51 on 10/10.  CT chest revealed ground glass opacification.  Echocardiogram revealed bicuspid aortic valve, mitral aortic insufficiency, LVH & normal ejection fraction.  ABG: pO2 62(L), pCO2 38, pH 7.35.  ECG abnormal.  WBC 8.8, H/H 8.7/26(L), plts 86K.  Sodium 132(L), BUN/creatinine 30/2.2.  Troponin 0.12.	UNK	UNK			PMH: atherosclerosis; chronic kidney disese; allergic rhinitis; temporal arteritis syndrome, giant cell arteritis, chronic renal insufficiency, osteoporosis, HTN, nephrolithiasis, B12 deficiency due to pernicious anemia; peripheral neuropathy, GERD, remote oral cancer, psoriasis.  Allergy: penicillin & quinine.  Ex-smoker.			1						1	Death; Dyspnoea; Pneumonia; Unresponsive to stimuli	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0330034	10/24/2008	MA	23.0	23		F	10/22/2008	33 year old woman was given flu vaccine during routine office visit. She was healthy at time of visit, with normal labs. She was also given dT. Flu: given 10/16/8 Vaccine manufacturer Sanofi: vaccine lot number 42847. dT: given 10/16/8 Vaccine manufacturer Sanofi U202MBA. Within 24 hours pt developed fever to 102, tachycardia to 148, and headache. She took OTC Motrin. She proceeded to hospital ER and was told she had a reaction to flu vaccine. She required IV fluids and was told that she was hypokalemic given oral K. She was D/C from ER to home. She was evaluated by me today 10/22/8 and still had minimal residual headache.  11/4/08 Reviewed PCP medical records & vaccine records of 10/16-10/22/2008. FINAL DX:flu shot reaction, fever. Records reveal patient experienced nasal drip, HA on 10/16.  Seen in ER on 10/17 w/flu-like symptoms of fever, loose stool x 1, generalized aching, weakness, nausea, poor appetite, tachycardia & HA. Tx w/IVF & meds.  Improved & d/c to home.  RTC 10/22 felt chilled, HA resolving.  Not to receive flu vax in future.				Y					N	10/16/2008	10/17/2008	1	pending from hospital  LABS: H/H 11.7/33.4(L), neutros 90.5%(H), lymphs 6.1%(L), monos 0.9%(L).  Sodium 135(L), potassium 2.9(L), magnesium 1.3(L).  CXR WNL.	UNK	UNK			none relevant; patient had bacterial vaginosis and was treated with local Rx; I don't know if she filled the Rx.  PMH: parathyroidectomy, breast reduction w/hypertrophic scars, umbilical hernia repair, smoker, migraines.  Allergy: eggs.			1						1	Headache; Hypokalaemia; Pyrexia; Tachycardia	DT~SANOFI PASTEUR~U202MBA~UNK~IM~UN~DT ADSORBED (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~42847AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330039	10/24/2008	WA	45.0	45		F	10/24/2008	Immunized on 10/20/08. Next day: stabbing pain in left shoulder, arm and side, especially when taken a breath. Went to see MD - he suspected it was caused from shot. Told her to take IBUPROFEN and to contact us. She contacted us on 10/23/08. Still symptomatic.				Y					N	10/20/2008	10/21/2008	1		OTH	OTH						1						1	Flank pain; Musculoskeletal pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330040	10/24/2008	KS	71.0	71		F	10/24/2008	By evening of 10/22/08 feeling increased pain and elevated temp (100 degrees). By 10/23/08 AM (LT) deltoid down to elbow is reddened, swollen and hot to touch. Erythema nearly the full circumference of upper arm. Had Dr examine the reaction while at the clinic with a friend on (10/24/08). Client is taking MOTRIN abd reports no fever today and that swelling and redness is lessening.									Y	10/22/2008	10/22/2008	0		PUB	UNK						1						1	Erythema; Pain; Pyrexia; Skin warm; Swelling	FLU3~SANOFI PASTEUR~U2701AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0989U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330041	10/24/2008	SC	61.0	61		F	10/24/2008	Injection given IM (R) delt., PNEUMOVAX vaccine.  05cc) Merck 0867 exp 12/4/09. Patient c/o chills arm swell, and redness with discomfort instructed to take IBUPROFEN. Swelling/redness over entire proximal arm.										10/23/2008	10/24/2008	1		PVT	PVT		No	Asthma			1						1	Chills; Discomfort; Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~U2739AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330042	10/24/2008		6.0			F	10/19/2008	Child received FLUMIST 10:00 a.m. Began running a fever of 103 that evening, and for the next four days, with nasal discharge, aches, no appetite.											10/11/2008			UNK	UNK						1						1	Anorexia; Pain; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0330043	10/24/2008		46.0			F	10/19/2008	8 days after receiving FLUMIST, became very ill with flu symptoms.										10/11/2008				UNK	UNK	FLUMIST administered October 11, 2008					1						1	Influenza; Malaise	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0330044	10/24/2008	GA	28.0	28		F	10/15/2008	Patient received flu vaccine on 10/08/2008 in left deltoid. On 10/9/2008 her left upper arm was very sore. Extending over her left collarbone. She also noticed a pea-size mobile bump above her left collarbone. She was evaluated 10/10/08 in our office - Temp 97.7? Placed on IBUPROFEN 600 mg three times daily. Ice/heat rotating onto (L) deltoid. 10/15/08 rechecked in our office - (L) deltoid not tender, but still with single soft, non tender mobile (L) supraclavicular lymph node.										10/08/2008	10/10/2008	2		UNK	UNK	Healthy - Only routine med is ORTHO EVRA PATCH - NKA					1						1	Lymphadenopathy; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA187AA~UNK~~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0330046	10/24/2008	NC	32.0	32		F	10/24/2008	Redness and swelling and warmth sensation.									Y	10/22/2008	10/22/2008	0		UNK	OTH						1						1	Erythema; Skin warm; Swelling	FLU3~SANOFI PASTEUR~89981~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330047	10/24/2008	CA	62.0	62		F	10/24/2008	Left arm 3cm redness and swelling to area mild - reaction.				Y					Y	10/21/2008	10/22/2008	1	Seen by MD	PVT	UNK		None	HX COPD, Depression, Migraines HA, HTN			1						1	Erythema; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLA366CA0~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1383u~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0330049	10/24/2008	OR	50.0	50		M	10/24/2008	Patient's right post lateral arm swelled up post his elbow. He went to the emergency room where he received antibiotic treatment.				Y					Y	10/21/2008	10/23/2008	2		OTH	OTH			None			1						1	Oedema peripheral	FLU3~SANOFI PASTEUR~U2753AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1381U~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0330050	10/24/2008	CO	53.0	53		F	10/24/2008	Approx 2 hr after Flu shot, pt started itching on her neck and arms, a red rash then developed and continued to itch. No prob with breathing but thought she might have hives on the back of her neck. called Dr - took BENADRYL and rash disappeared along with itching the same night.									Y	10/23/2008	10/23/2008	0	None	PUB	PVT		No	No			1						1	Pruritus; Rash erythematous; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA173AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0329989	10/25/2008	SD	66.0	66		F	10/25/2008	About 2 hours after having the flu shot, I fell and had a concussion.  I was taken to the emergency room and kept in the hospital overnight. I am having neurological tests and heart tests.  I don't know if there was a relationship between the shot and falling. I don't remember falling.  I don't have a clear memory of having the flu shot either.  1/19/09 Reviewed hospital medical records of 10/21-10/22/2008. FINAL DX: fall, head trauma, retrograde amnesia secondary to above, cause of fall unknown, scalp laceration sutured. Records reveal patient fell in parking lot while exiting vehicle.  Had HA, contusion & goose egg.  Exam revealed patient perseverating, vomiting, short term amnesia.  Neuro consult done.  DTRs reduced but present & equal.  CT scan w/area of hypodensity.  Improved & d/c to home w/PCP f/u & Holter monitoring as outpatient.				Y	Y	1			Y	10/21/2008	10/21/2008	0	LABS:  CBC, chemistry & CXR WNL.  EEG & CT scan bnormal.   CKMB 4.5(H).	UNK	UNK	Low dosage aspirin; Calcium with Vitamin D, Multi-Vitamin	None	None  PMH: multinodular goiter, breast biopsies, GERD, hay fever.  Allergy: iodine, betadine, penicillin.  Family hx: alzheimer's.			1						1	Concussion; Fall; Amnesia; Loss of consciousness	FLU3~SANOFI PASTEUR~U2766AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2766AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0329990	10/25/2008	WI	12.0	12		M	10/25/2008	Not himself, grandmal seizure at 2:35pm lasted 7mins afterwards had gotten severe chills and very nauseas the entire day and very tired but NO FEVER. Has had flu shots since 1996 has never had a reaction.  His Grandmal seizures only come on LATE at night not during the day ever and this one was different then his other ones.       This was done at my husband place of employment we always go there. They have nurses come in. you will have to talk to someone at office at that phone # I Gave you if you need more information.  Tell them it was done at office she is there contact person.  Or call me .									Y	10/21/2008	10/22/2008	1	N/A	UNK	UNK	clorazapate,Lamictal,Zonisamide,   robinal, cimedine	No	Spastic Quad CP, Seizures, gtube fed, nonverbal, nonambulatory	screaming nonstop 1 day~Diphtheria Toxoid + Pertussis + IPV (no brand name)~0~0.50~Patient		1						1	Chills; Fatigue; Grand mal convulsion; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA156AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0329993	10/25/2008	CA	21.0	21		M	10/25/2008	0835- RECEIVED FLUMIST; 0845- REPORTED TO MEIDCAL WITH C/O REDNESS/ ITCHING ALL OVER THE BODY; 0850- V/S STABLE O2 SAT AT 100% (BP: 117/73, P: 61, R:14, T: 97.2); 0900- ADMINISTERED DIPHENHYDRAAMINE HYDROCHLORIDE INJ 25ML AND ANOTHER 25ML AT 1010; 1100- PHYSICAL EXAM COMPLETED, V/S NORMAL, 100% O2 SAT.									Y	10/25/2008	10/25/2008	0		MIL	MIL						1						1	Body temperature; Erythema; Heart rate; Oxygen saturation normal; Pruritus generalised; Respiratory rate	FLUN3~MEDIMMUNE VACCINES, INC.~500569P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0329994	10/25/2008	PA	55.0	55		M	10/25/2008	Oct 15th, attack of Vestibular Neuronitis, admitted to emergency room, in hospital one day, released with Lorazapan & Prednisone, ok now.   May not be related to flu vaccine.  11/11/08 Reviewed hospital medical records of 10/16-10/17/2008. FINAL DX: vestibular neuronitis Records reveal patient experienced acute vertigo w/persistent vomiting.  Seen in ER but symptoms persisted & admitted overnight for continued observation & treatment.  Improved overnight w/IVF & meds.  D/C to home on steroid taper.				Y	Y	1			Y	10/12/2008	10/15/2008	3	LABS: CT of head WNL.  CBC & electrolytes WNL w/glucose 222(H) & phosphorous  1.4(L).	UNK	UNK						1						1	Vestibular neuronitis	FLUX~UNKNOWN MANUFACTURER~AFKKA175AA~UNK~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0329996	10/25/2008	AZ	34.0	33		F	10/25/2008	At the time of vaccination, pt was approximately 7 months pregnant. Pt called about an hour after vaccination and advised that she was feeling weak, a little dizzy, and nauseated. I advised she should call her doctor and explain her symptoms to the dr and proceed to urgent care or to the er. I called later and spoke to her husband and was advised that she was feeling better.									Y	10/07/2008	10/07/2008	0		UNK	PVT	none known		no known allergies, pregnancy			1						1	Asthenia; Dizziness; Drug exposure during pregnancy; Nausea	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329997	10/25/2008	IN	1.3	1	.3	F	10/25/2008	Ran 104.5 Temperature.  Signs of hives and rash on legs and back.  Site of shot was swolen and very red.  Lethargic at times.  Refusing anything to drink of eat.  11/03/2008 MR received for DOS 10/21/08 with DX: FUO. Likely immunization reaction. Pt presented to ER with fever, rash, lethargy and fussiness. Temp 104.3 in ER. PE (+) for redness with nodules on R & L thigh. No rash noted. Tx with abx awaiting cx and d/c same day.				Y	Y	2			U	10/20/2008	10/20/2008	0	Blood test, urine test, chest x-rays, lumbar puncture, antibiotics. Labs and Diagnostics: CXR WNL. CBC WNL. Blood cx and UC (-). PMH: none	UNK	UNK	None	None	None			1						1	Blood test; Body temperature increased; Diet refusal; Injection site erythema; Injection site swelling; Lethargy; Lumbar puncture; Rash; Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B064AA~UNK~~~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2761AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C68312~UNK~~~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0329998	10/26/2008	FL	26.0	26		F	10/26/2008	2 days following vaccine, slu like symptoms developed in the a.m.  After noon, redness and heat in face developed.  Early evening, swelling in face and under eyes developed.  No fever.  3 days following vaccine, eye lids swollen; eyes swollen shut.  Treated self with Benadryl.  Did not seek medical attention.  Day 4-5, swelling subsided.									Y	10/02/2008	10/04/2008	2		PUB	PVT		None	None			1						1	Erythema; Eye swelling; Eyelid oedema; Influenza like illness; Skin warm; Swelling face	FLU3~CSL LIMITED~01149111A~2~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0329999	10/26/2008	CA	26.0	26		F	10/26/2008	I received the vaccination around 1:00 pm on saturday. About 1 hour after that started to get a headache. For the rest of the day I felt ill, then around 8:00pm that night I took my temp and it was 99.9. Around 10pm I took my temp again and it was 104. I then preceeded to take 400 mg of motrin, then again at 11:00pm due to my temp being around 102. This morning (Sunday) my temp is at 100-101.									N	10/25/2008	10/25/2008	0	normal	PUB	PVT	no	no	no	high fever~Influenza (Seasonal) (Fluzone)~1~26.10~In Patient		1						1	Body temperature increased; Headache; Malaise	FLU3~SANOFI PASTEUR~49281038215~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330000	10/26/2008	CA	57.0	57		F	10/26/2008	sudden onset of severe upper and lower abdominal pain,diarrhea, syncope and near syncope, pain lasting severely for 12 hours, then moderate-severe for following 12 hours. I am still having symptoms. No fever. mild nausea. mild headache.									U	10/24/2008	10/25/2008	1	none yet	UNK	PVT	none	no known illness apparent	none			1						1	Abdominal pain; Diarrhoea; Headache; Nausea; Pain; Presyncope; Syncope	FLUX~UNKNOWN MANUFACTURER~NDC66521-0111-1~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330001	10/26/2008	TX	54.0	54		F	10/26/2008	THE PATIENT REPORTED LARGE SWELLING OF LYMPH NODES NEAR THE BREAST AND REDNESS AROUND THE BREAST. INJECTION SITE WAS VERY SORE.									U	10/24/2008	10/25/2008	1		UNK	UNK		NO	PATIENT IS ALLERGIC TO SULFUR.			1						1	Erythema; Injection site pain; Lymphadenopathy	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881176P~1~ID~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330002	10/26/2008	NH	33.0	33		F	10/26/2008	Symptoms: pain over injection site, severe ecchymosis over injection site (8.5 x 5.0 cm area), bronchial infection, dyspnea with bronchospasm requiring treatment with albuterol (the patients is not a known asthmatic).  Additionally, extreme fatique, muscle aches, headaches, nausea and emesis.  Treatment was done twice in the emergency room with albuterol.				Y					Y	10/14/2008	10/14/2008	0	Pending	UNK	UNK	Tri-vora (birth control pills), Prozac 20 mg daily, Klonopin 0.5 mg	none	none			1						1	Bronchial disorder; Bronchospasm; Dyspnoea; Fatigue; Headache; Injection site haemorrhage; Injection site pain; Laboratory test; Myalgia; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U2751AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330003	10/26/2008	AZ	42.0	42		F	10/26/2008	I receive a flu shot every year without incident.  This year, It seemed painful upon administration (larger, longer needle perhaps).  My arm and shoulder remained sore until present, as well as pain in the axillae of the immunized arm that developed the next day.  4 days post vaccination and the shoulder/armpit pain still remains with some swelling of the armpit.									Y	10/22/2008	10/22/2008	0		PUB	UNK	paxil 40mg po daily, ambien 10mg po qhs, spironolactone 50mg po BID, mirapex 0.125mg po QHS, adderall 30mg BID (7,1400)	slight cold developing, no fever.  just post nasal drip and sneezing	ace inhibitors = angioedema (worked up by immunologist), sleep apnea, adhd			1						1	Axillary pain; Injection site pain; Lymphadenopathy; Musculoskeletal pain; Pain in extremity	FLU3~CSL LIMITED~00749211A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0330005	10/26/2008	PA	34.0	34		F	10/26/2008	excrutiating pain in right arm, entire forearm red and swollen, temperature over 104 for 3 days, vomiting. Arm continues to be red and painful and swollen 4 days after vaccine was administered. Called dr. several times, she called in vicodan w/ibuprofen for extreme pain.  Took Benedryl and Motrin around the clock for four days so far.  Iced area for 20 min. many times per day. She determined it was a reaction to the pneumovax. Two lymph nodes extremely swollen and sore to the touch--under right arm and above right collar bone.									Y	10/22/2008	10/23/2008	1		PVT	PVT	advair, singulair, nexium, trivora 28, simvastatin, albuterol	none	severe persistent asthma, high cholesterol, reflux			1						1	Body temperature increased; Erythema; Immunisation reaction; Lymph node pain; Lymphadenopathy; Oedema peripheral; Pain in extremity; Vomiting	FLUX~UNKNOWN MANUFACTURER~~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330006	10/26/2008	OH	5.0	5		F	10/26/2008	09/30/08 patient complained of hurting feet, 10/01/08-morning patient had swollen right ankle and toes, pruritic rash all over abdomen-pediatrician office said to treat with Benadryl; by evening-patient's feet and hands were so swollen she had trouble moving her standing and moving her fingers-we took her to the ER-they diagnosed Henoch-Schoenlein Purpura; 10/06/08-patient began with GI symptoms with vomiting and she refused to eat or drink for the next 4 days and became dehydrated and we took her back to the ER where they admitted her for 1 day; she improved but has continued to have vasculitis events the next several weeks.  2/17/09 Received hospital medical records for 10/9-10/10/2008. FINAL DX: gastroenteritis & dehydration Records reveal patient experienced HSP 8 days prior w/LE swelling, pain & petechia.  Developed sore throat & seen by PCP 4 days prior to admit.  Throat c/s (+) for strep & started on antibiotics.  Night before antibiotics started, developed emesis x 1 & reduced oral intake since then.  Lost 3.5 # since PCP visit w/decreased UOP.  Tx w/IVF & admitted overnight for observation.  Did well & appetite improved.  D/C to home on continued oral antibiotics w/PCP f/u.				Y	Y	1			Y	09/29/2008	09/30/2008	1	No blood in urine; all other labs were normal	UNK	UNK	None	None	None			1						1	Blood urine absent; Dehydration; Diet refusal; Henoch-Schonlein purpura; Joint swelling; Laboratory test normal; Oedema peripheral; Pain in extremity; Rash pruritic; Vasculitis; Vomiting; Blood creatine phosphokinase normal; Blood creatinine normal; Blood potassium normal; Blood sodium normal; Blood urea normal; Carbon dioxide normal; Eosinophil percentage; Full blood count; Haematocrit increased; Haemoglobin increased; Henoch-Schonlein purpura; Lymphocyte percentage; Monocyte percentage; Neutrophil percentage; Oedema peripheral; Platelet count normal; Urine analysis normal; White blood cell count normal	FLU3~SANOFI PASTEUR~U2763AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2763AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0330023	10/26/2008	TX	66.0	66		F	10/26/2008	A little bit of bleeding, pt complained of itchiness the night of immunization; then complained of throbbing pain.									Y	10/25/2008	10/25/2008	0		OTH	PUB	ENALAPRIL, ATENOLOL, CATAPRES PATCHES					1						1	Haemorrhage; Pain; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0038U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330024	10/26/2008	PA	61.0	61		F	10/26/2008	Pt. felt chills and delirious, confused for 3-4 minutes. Injected EPI  pen, Pt. sat for 5 minutes and we called 911 paramedic took to hospital, was stable BP. 114/85, pulse 72 was released after few hours.									N	10/25/2008	10/25/2008	0		OTH	PVT	ATENOLOL, ZOLOFT, ZOCOR, MUL, CAL & VIT. D	No	No			1						1	Chills; Confusional state; Delirium	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0329010	10/27/2008	IL	0.5	0	.5	M	10/24/2008	Information has been received from a physician and a nurse concerning a 6 month old male with no medical history or allergies, who on 10-JUN-2008, 04-AUG-2008 and 06-OCT-2008 was vaccinated PO with 2.0 ml of the first, second and third doses respectively of ROTATEQ (dose 1 lot # 660376/0019X, dose 2 lot # 660926/0308X and dose 3 lot # 661428/0898X). Concomitant vaccine therapy included a dose of PREVENAR (lot # C86140), a dose of PENTACEL (lot # C3174AA) and a dose of FLUZONE (lot # U2809AA). The nurse reported that on 09-OCT-2008, the patient was seen by the physician. It was reported that the patient had a fever, was vomiting and had a lump on the right side of the belly. On 09-OCT-2008, the patient was hospitalized and was treated with a barium/air contrast enema, the intussusception was not reduced. The patient had surgery to reduce the intussusception. On 13-OCT-2008 the patient was discharged from the hospital. On 16-OCT-2008, the patient was seen by the physician, it was reported that the patient was doing well and had recovered. The reporter considered intussusception to be an other important medical event. A product quality complaint was not involved. Additional information has been requested.				Y	Y	4			Y	10/06/2008	10/09/2008	3	barium enema X-ray, 10/09/08, intussusception not reduced; surgery, 10/09/08, to reduce intussusception	OTH	OTH			None		WAES0810USA03400	1						2	Enema administration; Intussusception; Surgery; Abdominal mass; Barium enema abnormal; Intussusception; Pyrexia; Surgery; Vomiting	DTAPIPVHIB~SANOFI PASTEUR~C3174AA~1~IM~LL~DTAP + IPV + HIB (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U2809AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C81640~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0898X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1|DTAPIPVHIB~SANOFI PASTEUR~C3174AA~UNK~UN~UN~DTAP + IPV + HIB (PENTACEL)~2|FLU3~SANOFI PASTEUR~U2809AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|PNC~PFIZER\WYETH~C86140~UNK~UN~UN~PNEUMO (PREVNAR)~2|RV5~MERCK & CO. INC.~0898X~3~PO~MO~ROTAVIRUS (ROTATEQ)~2	USA	Hospitalisation	Influenza
0330007	10/27/2008	MN	42.0	42		M	10/27/2008	10/21/08:  Visual aura lasting approximately 20-30 minutes beginning 18:20.  Minor headache, only 2-3 on scale of 10.  Diagnosed as classical migraine by ER Neurologist.  Isolated event, no treatment recommended (no prior or family history of migraine).  10/22-25/08:  Mild headache, no treatment sought, took Ibuprofen with some effectiveness.  10/25/08:  Dizziness upon waking, 08:00.  Mild headache, feels like fever but temp normal (98.6 dF).  No treatment sought.				Y					N	10/13/2008	10/21/2008	8	10/21/08:  CT scan negative.  EKG normal.	UNK	UNK	None.	None.	None.	None~ ()~~0.00~Patient		1						1	Aura; Computerised tomogram normal; Dizziness; Electrocardiogram normal; Headache; Migraine	FLU3~SANOFI PASTEUR~U2806AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330056	10/27/2008	CA	61.0	61		M		Fever. (L) deltoid with erythema (covering deltoid). Warmth, tenderness (injection site). 10/28/08-records received for DOS 10/17-10/19/08-DC DX: Cellulitis left deltoid, improved. Cough. Presented with fever and left arm pain, difficulty walking. At time of discharge gait normal.					Y	2			Y	10/14/2008	10/15/2008	1	10/28/08-records received- WBC 3.3, hemoglobin 9.0.	PVT	PVT		Lung cancer	Sulfa; Erythromycin 10/28/08-records received-PMH: metastatic small-cell carcinoma of lung with paraneoplastic syndrome (Lambert-Eaton syndrome). Chronic anemia, presumable secondary to chemotherapy. Depression. Hyperlipidemia. Actinic keratosis. Gastroesophageal reflux disease. Chronic back pain. Allergies to sulfa and erythromycin			1						1	Injection site erythema; Injection site pain; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U2742AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0870X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0330059	10/27/2008	TX	73.0	73		F	10/20/2008	None stated. 11/4/08-records received for DOS 10-18-10/19/08-DC DX: Allergic reaction to influenza shot. After receiving flu shot C/O throat swelling and tingling sensation and numbness in face. Tongue swelling and pressure in chest. Treated in ED and admitted.				Y	Y	1			Y	10/18/2008	10/18/2008	0	11/4/08-records received-D-Dimer 3.37 elevated. Creatinine 1.6. BUN 29,  VQ scan normal. WBC 13.4	PUB	PUB		None	11/4/08-records received-PMH: hypertension.			1						1		FLU3~SANOFI PASTEUR~U2811AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0330060	10/27/2008	MS	53.0	53		F	10/22/2008	Itchy, redness, swelling, burning sensation at site 1 day after injection. No reactions to previous flu shots.									Y	10/20/2008	10/21/2008	1	None	PUB	OTH	Premarin	None	No			1						1	Injection site erythema; Injection site irritation; Injection site pruritus; Injection site swelling; No reaction on previous exposure to drug	FLU3~CSL LIMITED~02449111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0330065	10/27/2008	LA	11.0	11		F	10/22/2008	Left arm red painful swelling 12cm X 4cm.										10/20/2008	10/21/2008	1		PVT	UNK		None				1						1	Erythema; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2806AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1140X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0330066	10/27/2008	NY	11.0	11		M	10/23/2008	Mom reports left arm pain radiating to hand, swelling at vaccine site, able to rotate wrist and move fingers.  Occurred 4 hours post vaccine - spoke with mom today - improving and decreased swelling.									Y	10/22/2008	10/22/2008	0		PVT	UNK		None				1						1	Injection site swelling; Pain in extremity	FLU3~SANOFI PASTEUR~U2762AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330067	10/27/2008	SC	2.0	2	.8	M	10/22/2008	Due to age, patient was to have 0.25ml of vaccination. Patient was given 0.5ml of flu vaccine. No known reaction.									Y	10/21/2008			None	PVT	PUB		None	None			1						1	Incorrect dose administered; No adverse event	FLU3~SANOFI PASTEUR~U2828AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330069	10/27/2008	CA	38.0	38		F	10/24/2008	Received IZ 10/22/08; 1st sign itching immediately after on both deltoids.  Noticed redness and swelling today.  Right shoulder has silver dollar sized erythema with slight swelling and slight pain about 1 inch below the shot.  Left shoulder shows 2 dime size and 2 nickel size reddened area, underneath shot as well.  Local reaction.									Y	10/22/2008	10/22/2008	0	None	PVT	PVT	Insulin; Depo; CRESTOR	None	Diabetes; High cholesterol			1						1	Erythema; Immediate post-injection reaction; Local reaction; Pain; Pruritus; Swelling	FLUX~SANOFI PASTEUR~U2747AA~2~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0380V~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330070	10/27/2008	IL	75.0	75		F	10/12/2008	Patient arm red and inflamed. Patient said she was up all night Friday after the shot was given. She says she has pain and then it goes away. Sunday 10/12 she started taking Benadryl and says it is getting better.									U	10/10/2008	10/10/2008	0		OTH	OTH						1						1	Erythema; Inflammation; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0867X~6~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330071	10/27/2008	LA	85.0	85		F	10/17/2008	Itchy, red rash all over body. Kenalog 1cc IM. Medrol Dose Pak as directed. Atarax 25mg tid PRN.									Y	10/15/2008	10/15/2008	0		PVT	PVT	None	None	History Gastritis, Gerd, Anxiety, DJD, Hyperlipidemia, Anemia			1						1	Rash erythematous; Rash generalised; Rash pruritic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89966~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330072	10/27/2008	MI	1.08	1	.1	F	10/21/2008	Pt has food allergies, mild reaction to milk and egg. Approximately 1 hour after received flu vaccine developed hives with severe itching. Spoke with provider who advised Benadryl & ER. 2:00 Mom did not take to ER (Spoke with Nurse) hives gone breathing fine, playing. Discussed never to receive flu vax in future.  10-21-08 spoke with mom. Continues to be doing fine, no hives, no breathing problems.									Y	10/20/2008	10/20/2008	0		PVT	UNK		None	Wheat, peanut, milk and egg allergy			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~UT2788FA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB297~4~IM~RL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~C71571~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0330076	10/27/2008	WA	4.0	4		F	10/16/2008	Red welts on face and body.  R eye swollen c/o throat tickle 1-2 hrs after vaccine admin.  Taken to ER.  Resolved on own.  Physician prescribed BENADRYL 3xday x5 days plus flu with PCP.				Y						10/10/2008	10/10/2008	0		PUB	PUB			Enlarged spleen s/p malaria (documented on immigration forms)			1						1	Erythema; Eye swelling; Throat irritation; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500560P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB246AA~1~IM~LA~HEP A (HAVRIX)~1|HIBV~SANOFI PASTEUR~UF439AA~4~IM~LA~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~1217F~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C22283~1~IM~RA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0330085	10/27/2008	CA	54.0			F	10/24/2008	Information has been received from a pharmacist concerning a 54 year old female with fibromyalgia who on 13-OCT-2008 was vaccinated with PNEUMOVAX 23 0.5 ml IM (therapy site unknown).  Influenza virus vaccine (manufacturer unspecified, route unknown) was given on the same day in the same arm.  After receiving PNEUMOVAX 23 the patient developed swelling, pain and redness at the injection site.  The patient telephoned and reported to the pharmacist that the area affected was about 6 inches around her arm, and felt like a burning sensation.  At the time of this report, patient was recovering.  A Lot check has been initiated.  Additional information has been requested.  This is one of several reports received from the same source.								Y	N	10/13/2008	10/13/2008	0	None	OTH	OTH	Unknown	Fibromyalgia			WAES0810USA03214	1						1	Burning sensation; Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0619X~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0330091	10/27/2008	AZ				U	10/21/2008	Initial report received from a healthcare professional on 17 October 2008.  Cluster of six unidentified patients experienced itchy and swollen throats after receiving FLUZONE SV 2008-2009 (lot number U2740AA).  The six patients arrived together at a flu clinic on 15 October 2008.  One hour after receiving their FLUZONE vaccines, the patients drove back to the clinic, all six complaining of itchy and swollen throats.  A nurse at the clinic sent one of the patients to the emergency room.  Outcome was unknown for the six patients.  Documents held by sender: None.				Y					U	10/15/2008	10/15/2008	0	Unknown	PVT	OTH	The following information was reported to be unknown: concomitant medications.	The following information was reported to be unknown: illnesses at the time of vaccination.	The following information was reported to be unknown: concomitant medications, illnesses at the time of vaccination, pre-existing allergies/medical conditions, adverse events following prior vaccinations, other vaccinations given within 4 weeks of 15 October 2008.		200803245	1						1	Pharyngeal oedema; Throat irritation	FLU3~SANOFI PASTEUR~U2740A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330096	10/27/2008	PA	75.0	75		M	10/21/2008	Patient became unresponsive and vomited while driving.  He had probable seizure activity.  Patient was transported by ambulance to the ER and had several more episodes of unresponsiveness with elevated heart rate and shakes.				Y	Y	2			Y	10/15/2008	10/16/2008	1	Lab work; EKG; CT Head; NICS; MRI Head; EEG - All fairly normal.	PVT	PVT	ASA 81mg; Amcadipine 2.5mg QD	None	HTN; S/P CA Prostate; Mild dementia			1						1	Electrocardiogram normal; Electroencephalogram normal; Heart rate increased; Nuclear magnetic resonance imaging brain normal; Scan brain; Tremor; Unresponsive to stimuli; Vomiting	FLU3~SANOFI PASTEUR~U2744AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0330097	10/27/2008	NY	50.0	50		F	10/22/2008	Difficulty breathing, hoarseness, wheezing, heightened BP & pulse, bloodshot eyes. Treatment: OTC allergy pills.									Y	10/21/2008	10/21/2008	0		PUB	PVT						1						1	Blood pressure increased; Dysphonia; Dyspnoea; Heart rate increased; Ocular hyperaemia; Wheezing	FLU3~SANOFI PASTEUR~U2750AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330098	10/27/2008	CO	37.0	37		F	10/21/2008	Initial reaction- had a metallic taste in throat then trouble swallowing - progressed to having some difficulty breathing.  Administered 0.3 ml of EPI to R deltoid, O2 at 1.5  L via nasal cannulla., BENADRYL 25mg po.				Y						10/21/2008	10/21/2008	0		PUB	OTH	TRAZADONE 150mg; POB10		PCN			1						1	Dysgeusia; Dysphagia; Dyspnoea	FLU3~SANOFI PASTEUR~92748AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330099	10/27/2008	MD	72.0	72		F	10/22/2008	Large red area at site with tenderness, swelling.									N	10/20/2008	10/27/2008	7		PUB	PUB	Unknown		Diabetic; Parkinsons			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2764AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330100	10/27/2008	UT	5.0	5		M	10/20/2008	10X12cm area of induration and swelling at vaccination				Y					Y	10/16/2008	10/17/2008	1		PVT	PVT	BENADRYL given	Healthy	Asthma			1						1	Injection site induration; Injection site swelling	FLU3~SANOFI PASTEUR~U2752AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330101	10/27/2008	CA	52.0	52		M	10/21/2008	330 PM had feeling of lump in throat; 630 PM not feeling well, lump in throat causing some coughing. Had increase nausea in the evening and his eye were burning & turning red.  At 10 PM he vomited violently, repeatedly and his eyes turned blood red. He had fever that night, malaise, HA & weakness 10/17 & 10/18; felt better 10/19.									Y	10/16/2008	10/16/2008	0		OTH	PVT	Med for high cholesterol	None	High Cholesterol			1						1	Asthenia; Cough; Eye irritation; Headache; Malaise; Nausea; Ocular hyperaemia; Pyrexia; Sensation of foreign body; Vomiting	FLU3~SANOFI PASTEUR~U2757AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330103	10/27/2008	FL	68.0	68		F	10/21/2008	Swelling of arm, red hot, itching, fever, throwing up.  Given Ciprofloxacin 500mg. twice a day for one week.									Y	10/13/2008	10/13/2008	0		PUB	OTH		None	None			1						1	Erythema; Oedema peripheral; Pruritus; Pyrexia; Skin warm; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0330105	10/27/2008	MI	29.0	29		M	10/21/2008	Redness and swelling right upper arm and shoulder. Seen at office 4 days following vaccine. Treated with Medrol dose pack and Amoxil. Questionable early celluitis vs. immune system reaction to vaccine. No fever.				Y					U	10/16/2008	10/19/2008	3	None	PVT	UNK		None	Asthma			1						1	Erythema; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~87923~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0519X~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0330106	10/27/2008	NY	35.0	35		F	10/20/2008	headache,  fever up to 102+, dizzy and light headedness, stiff neck, pain in arm (around injection site) L , burning in arm, muscle twitches in arm									Y	10/16/2008	10/17/2008	1		MIL	MIL	Birth Control	None	Sulfa, anemia			1						1	Burning sensation; Dizziness; Headache; Injection site pain; Muscle twitching; Musculoskeletal stiffness; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB584AA~3~IM~LA~HEP B (ENGERIX-B)~1|TDAP~SANOFI PASTEUR~C3029AA~2~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0330108	10/27/2008	OH				F	10/20/2008	Flu shot rec'd at 9:30 am 10/20/08. C/o headache. Lighted headed and dizziness and (L) arm pain. Onset 1245.				Y					Y	10/20/2008	10/20/2008	0	CBC, Chem, Chest X ray, CT Brain	PVT	OTH	None	None	Hypertension; Thyroid; Back surgery; Hysterectomy			1						1	Chest X-ray; Dizziness; Full blood count; Headache; Laboratory test; Pain in extremity; Scan brain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0330109	10/27/2008	OH	6.0	6		M	10/21/2008	Left arm became red, a little swollen & hot to touch within 24 hours after vaccine. At 36 hours patient was red from shoulder to below elbow. Patient was seen in the office put on Benadryl every 6 hours and Keflex for cellulitis.				Y					Y	10/16/2008	10/17/2008	1		PVT	PVT	Albuterol MDI	No	Asthma / Seasonal Allergies			1						1	Cellulitis; Erythema; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U2757AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330110	10/27/2008	MI	4.0	4		M	10/17/2008	Small papules (hives) >40, itchy, red, esp. on trunk 5d after injection									Y	10/11/2008	10/16/2008	5		PVT	PVT		None	None			1						1	Erythema; Pruritus; Rash papular; Urticaria	FLU3~SANOFI PASTEUR~U2752AA~5~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330111	10/27/2008	MI	51.0	51		F	10/31/2008	High fever 102.7 for 24 hrs then started to break. Chills almost to conuations for 6 hrs Elevated heart beat-burning ears and eyes vomiting and weakness									Y	10/16/2008	10/16/2008	0		PVT	UNK	THEODUR;CLONIDINE;Acropart and Albuterol Inhalers;VOLTARIN-prednisone; Atrovent Sol.; FOSAMAX	Bronchitis/asthma	Penicillin			1						1	Asthenia; Chills; Ear discomfort; Eye irritation; Heart rate increased; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330112	10/27/2008	MI	53.0	53		F	10/16/2008	Pt stating arm is very sore, difficulty moving it. Pt is taking Motrin and using hot pack. Reaction lasting >2 days.									U	10/13/2008	10/14/2008	1		OTH	PVT		None				1						1	Injected limb mobility decreased; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~1~UN~AR~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330113	10/27/2008	PA	47.0	47		M	10/22/2008	Rec'd vaccine on 10/8/08 at work, symptom onset on 10/18/08: Body aches, fatigue, chest tightness, scratchy throat, cough lasting for several days.									Y	10/08/2008	10/18/2008	10	None	OTH	OTH	Metoprolol  QD		Squamous cell carcinoma of lip; Gout	Sames as described From previous flu vaccinations~Influenza (Seasonal) (FluLaval)~UN~0.00~Patient		1						1	Chest discomfort; Cough; Fatigue; Pain; Throat irritation	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA208AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0330116	10/27/2008	MN	54.0	54		F	10/21/2008	Stuffy, headache, coughing throat tightening, sinus pain. Severe headache that evening.									Y	10/15/2008	10/15/2008	0		PUB	PVT	Cymbalta; Prevacid; Prilosec		Seasonal Allergies			1						1	Cough; Headache; Nasal congestion; Sinus headache; Throat tightness	FLU3~SANOFI PASTEUR~U2810AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330117	10/27/2008	MD	64.0	64		F	10/17/2008	Shot received on 10/15/08.  Patient noticed increased pain in left upper arm in the PM of 10/15/08.  On 10/16/08 patient noticed increased redness and swelling of upper arm.  She also had generalized symptoms - nausea and light headed.  Patient took Tylenol and went to bed - general symptoms subsided.  Started ice pack to left upper arm.									Y	10/15/2008	10/16/2008	1	None at this time.	OTH	PVT	VERAPAMIL; LIPITOR; ARTHROTEC; LISINOPRIL; FEMARA; OSCAL	None	Seasonal allergies			1						1	Dizziness; Erythema; Nausea; Oedema peripheral; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0867X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330118	10/27/2008	WI	6.0	6		M	10/20/2008	Diarrhea which included mucous and blood starting day after administration of FLUMIST.  Saw on call MD on 10/18 and was to call for stool culture orders if persisted to today.  Reporting per O/C MD request.				Y					U	10/14/2008	10/15/2008	1	None	PVT	PVT	None	None	None			1						1	Diarrhoea; Diarrhoea haemorrhagic	FLUN3~MEDIMMUNE VACCINES, INC.~500558P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0330120	10/27/2008	NE	47.0	47		F	10/22/2008	10/21/08 22:30 chills and mouth chattering.  White colored hands couldn't get warmed-up for 3 hours.  Frequent vomiting.  Slight wheezing noted.									Y	10/21/2008	10/21/2008	0		OTH	PVT	Coreg; Plendel	None	HTN			1						1	Chills; Skin discolouration; Vomiting; Wheezing	FLU3~SANOFI PASTEUR~U2766AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330134	10/27/2008	IN	70.0	70		F	10/27/2008	Although shot was painful no reaction for 2 days then a great deal of pain tingling up my neck and down my upper right arm where shot was given. The pain comes in waves. This started 10/20 and has continued.									N	10/18/2008	10/20/2008	2	I don't like going to doctors	UNK	PVT		No	Arthritis			1						1	Injection site pain; Pain in extremity; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330140	10/27/2008	MI	54.0	54		F	10/27/2008	I received the vaccine at approximately 1 p.m. on October 22, 2008.  At 5p.m., I was feeling tired, but decided to attend my regular exercise class anyway.  Class ended at 6:30, and on the way home I suddenly developed a cough that was painful in my chest.  The painful cough persisted, and I lost my voice and was having slight trouble breathing.  I took a quick dissolve Benadryl and used an old Albuterol inhaler that I had from a previous bout with bronchitis, and I went to bed.  The next day the cough was gone. I have never had an adverse reaction before, and I have been getting flu vaccine for many years.   I'm hoping this doesn't mean that I can never get a flu vaccination again.									Y	10/22/2008	10/22/2008	0		UNK	UNK	Vitamins, glucosamine & chondroitin, fish oil, black cohosh	None.	I am allergic to sulfa and penicillin.			1						1	Aphonia; Chest pain; Cough; Dyspnoea; Fatigue; No reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330141	10/27/2008	NM	56.0	56		F	10/27/2008	Administered flu mist at public clinic 10-11-08, in a large room. Worked from 10 am to 4:43 pm. IM and FluMist given. During clinic lungs became tight and I required Ventolin inhaler. Sunday night became ill, asthma. Saw MD on Monday and Wed. Started on predinisone 60 mg, tappering q 3 days. Increased Advir, I have 7 doses, nurses in close proximity to me gave a toatl of 39 doses of FluMist. MedImmune Lot 500646P. IM Flu vaccine given during clinic.				Y					Y	10/11/2008	10/19/2008	8		UNK	UNK		None	Asthma, Advir 500/50,Ventolin prn, claritin, Prednisone in tapering doses q 3 days			1						1	Accidental exposure; Asthma; Condition aggravated; Malaise	FLUN3~MEDIMMUNE VACCINES, INC.~500646P~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0330142	10/27/2008	NC	59.0	59		F	10/27/2008	BODY ACHES, VOMITTING, RED MACULAR RASH ON TORSO AND LOWER EXT.									Y	10/23/2008	10/24/2008	1		UNK	PVT	ALBUTEROL INHALER, ALLEGRA, AMITRIPTYLING, BUMEX, CELEBREX, CHLORZOXAZONE, COLCHICINE, COUMADIN, LACTINEX, LANTUS, NYSTATIN OINTMENT, PAXIL, PRILOSEC, REGLAN, SINGULAIR, SYNTHROID, VERELAN, VISTARIL, VYTORIN	NONE	ALLERGY TO  PCN, LORTAB, CLINDAMYCIN, ADHESIVES;  MED HX: DIABETES MELLITUS II, MORBID OBESITY, ANEMIA, GOUTY ARTHROPATHY	NONE~ ()~NULL~~In Patient|NONE~ ()~NULL~~In Sibling1|NONE~ ()~NULL~~In Sibling2		1						1	Pain; Rash erythematous; Rash macular; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88634~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330144	10/27/2008	PA	48.0	48		F	10/27/2008	Approximately 30 minutes after vaccine administered, I started to experience nausea. In another 20 minutes I started to have head pain. Within the next 2 hours I developed a fever, aches, chills, intensified headache, more severe nausea, and overall fatigue. These symptoms lasted through to the next day around 8 pm when I was finally able to sit up and walk around a bit.									Y	10/22/2008	10/22/2008	0		UNK	UNK	Allegra D		Allergy to ibuoprofen and naprosen, as well as various pollens (e.g., ragweed), and certain raw fruits (e.g., apples)			1						1	Chills; Fatigue; Headache; Nausea; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330145	10/27/2008	MD	66.0	65		F	10/27/2008	Pt. complains of swelling and redness in L extremity with pain that radiates to breast area.									U	10/07/2008	10/08/2008	1	none	PUB	PVT	Cholesterol med and vitamins	none	none			1						1	Breast pain; Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~U2832AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330146	10/27/2008	MO	57.0	57		M	10/27/2008	weakness accompanied by joint pain beginning in left elbow (vaccination performed in left deltoid) and proceeding to other joints in left arm including fingers and then to right elbow and vertabrae from T6 into neck area -- suspected sulfites because of pimple breakout and muscle spasms in face and jaw									N	10/20/2008	10/20/2008	0		UNK	PVT	none	none	penecillin allergy			1						1	Acne; Arthralgia; Asthenia; Muscle spasms	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330147	10/27/2008	MO	78.0	78		M	10/27/2008	Within 8 hours of vaccine administration, patient had fever up to 103, cough, and ataxia. He called his PCP and he used Benadry and fever reducer.No further treatment needed. He was afebrile by next morning. Wife reported the reaction on 10/24/08 to the clinic. Unable to reach patient until 10/25/08 for confirmation of this.									Y	10/23/2008	10/23/2008	0	None	UNK	PVT	None listed	None	None known			1						1	Ataxia; Cough; Pyrexia	FLU3~SANOFI PASTEUR~U2806AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330148	10/27/2008	CO	0.8	0	.8	M	10/27/2008	Patient received Fluzone on Monday 10.21.08, and died on Tuesday pm on 10.22.08  12/18/08 Autopsy report states COD as sudden unexplained infant death.  Manner of death is undetermined.  Report also states patient getting over cold w/runny nose & cough, no fever, on day of vaccination.  Had been put to sleep on back & found on stomach in crib.	Y	10/22/2008							N	10/21/2008	10/22/2008	1	Per pathologist unsure of cause of death at this time, lab work being done ? SIDs, also noted no erythemia or swelling at injection site.	UNK	UNK		None noted at well child check done at time of visit.	Previous UTI, VCUG done with normal results, and hernia (resolved)			1						1	Death; Laboratory test; Death	FLU3~SANOFI PASTEUR~UA2828AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2828AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0330149	10/27/2008	MN	60.0	60		F	10/27/2008	Pt. called to report: Rec'd flu vaccination on 10/22/08. Approximately 4 hrs after vaccination had difficulty breathing, self-medicated with one Benadryl capsule, symptons subsided in approximately 20 minutes and did not return.									Y	10/22/2008	10/22/2008	0		PVT	PVT	VerapamilSR, ASA, Pepcid-prn, Nitro-prn, Lovastatin, Lisinopril, Multi-Vitamin,Zoloft, Calcium w/vitD	None	ASCVD, Barrett's Esophagus, Hypercholesteremia			1						1	Dyspnoea	FLU3~SANOFI PASTEUR~U2833AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330150	10/27/2008	CT	74.0	74		F	10/27/2008	Patient called PDDH on 10/27/08 and informed nurse her shoulder has been aching since she received flu shot 3 weeks ago. Instructed her to f/u with her physician.									U	10/07/2008	10/07/2008	0		UNK	UNK		none				1						1	Musculoskeletal pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA373AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330151	10/27/2008	VA	43.0	43		M	10/27/2008	Severe joint pain, stiffness, and minor swelling									U	10/24/2008	10/25/2008	1		UNK	UNK	Ibuprofen	No	None			1						1	Arthralgia; Joint stiffness; Joint swelling	FLU3~SANOFI PASTEUR~U2760AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330153	10/27/2008	OH	42.0	42		M	10/26/2008	patient was administered flu vaccination on 10/14/2008 within started experiencing headaches which could not be relieved with medicine. this continued along with a fever until hospitalization was required on 10/20/2008.Viral meningitis was diagnosed upon admission.3/19/09-records received dor DOS 10/22-10/27/08-DC DX:Viral meningitis, nausea, vomiting, headache, depression. Presented to ED with headache, nausea, vomiting. Flu-like symptoms started week ago, headache associated with fever, neck pain sensitivity to light and blurred vision, headache exacerbated by any movement, light noise and position. 3/27/09-records received for DOS 11/25-12/4/08 and 12/12-12/15/08 DC DX: HSV-2 meningitis. Presented with fever, chills, headache, nausea, vomiting diffuse back pain and right medial forearm and finger numbness. Began feeling ill 1 month prior following flu shot. Myalgias, malaise and generalized pressure like headaches, tinnitus and nausea. Episode of aphasia.  Acute kidney injury secondary to acyclovir induced crystalline disease.				Y	Y	14			U	10/14/2008	10/16/2008	2	available at clinic and hospital  3/19/09-records received-CT negative. WBC 11.6, CSF 65-95 WBC, red cell 250, protein 89 and glucose 60. 3/27/09-records received-CT head normal. Lumbar puncture 410 WBC, 36 neutrophils, protein 111, glucose low 37, cultures negative. Creatinine increased 4.28, hyperphosphatemia and hypernatremic. PCR CSF positive for HSV type II.	UNK	UNK	lexapro	none	none 3/19/09-records received- PMH:anxiety and lymph node removal. Allergies to penicillin, morphine and erythromycin.			1						1	Headache; Meningitis viral; Pyrexia	FLU3~SANOFI PASTEUR~90658/90471~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0330154	10/27/2008	CA	59.0	59		F	10/27/2008	headache, dizziness, nausea, arm soreness. Began the morning after the injection and lasted the entire day. Ibuprophen taken.									Y	10/24/2008	10/25/2008	1		UNK	UNK						1						1	Dizziness; Headache; Nausea; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330156	10/27/2008	PA	0.5	0	.5	F	10/27/2008	Dear Sir or Madam;   My 6 month daughter received her flu vaccination on September 18.  Since receiving the vaccination, my angelic child, who was always smiling and laughing was not herself.  She became collicky, often crying and she vomited the day she received the vaccination.  (Thursday, September 18)  That weekend (September 19,20,21) she had a small fever and we called the doctor and he told us there was a bug going around and to treat her with just Tylenol every 3 hours.  (Friday the 19th)     The following week, my child was still different.  She did not laugh as much, she was colicky, though her appetite did not change.  She would cry if she sat for a long time, even if she was held upright a long time.  The weekend of 27,28 my child was running a fever again and I again called the doctor who made the diagnosis over the phone that it may be teething or the flu and to treat the fever with Motrin and bring her in if things don't get better.  They did not get better, they got worse and we brought patient to the doctor on Wednesday October 1.  She was rushed to the hospital and admitted with a kidney and bladder infection.  She was treated with an IV antibiotic and her white blood cell count was 26000.  My poor little 6 month old baby screamed with all the IV issues (they could not get the needle in properly), as they took blood from her the next 3 days in the hospital multiple times, waking her to take her temperature at night (she was running a fever), doing urine tests with catheders, etc.   Her white cell blood count went as high as 38,000 before a second antibiotic was able to treat is and get it down.  It was a horrible, horrible experience for my daughter and my whole family.     My good angel of a child is now out of the hospital and she is terrified of strangers due to her experience in the hospital.  The 2nd IV they attempted, they blew a vein 3 times before getting it right.  She was in so much pain that she would cry for hours at night.     I knew this all happened due to an adverse effect to the flu vaccine and now I read that there was a flu vaccine that was tainted that led to Urinary Tract Infections (which patient was diagnosed with).  I knew she wasn't right ever since the flu vaccine and now my daughter may have permanent kidney damage due to urine going backwards from the bladder.  We are going back for testing in 4-6 weeks and she has to take an oral antibiotic for 6 months to try to prevent this from happening again.  What is my recourse for your error with this flu vaccine???  I took my daughter to the doctor's thinking she would be given proper medical treatment, not just to  be stuffed with profitable, unnecessary vaccines!  Since being treated with an antibiotic for the last 21 days, my daughter has developed a rash on her face and the rest of her body.  I spoke with the nurse at Dr's office and she commented that they have seen an uptick in UTI's in babies, coincidentally, they have all received the flu vaccine.     I would like to file a formal complaint.  I am so angry that the flu vaccine possibly did permanent damage to the psyche and health of my child.    11/6/2008 MR received for DOS 10/01-7/2008 with DX: Febrile UTI/Pyelonephritis. Pt presented with 5 day hx of fever with irritability, fussiness and poor feeding. PE WNL except T=101.2'F.  Tx with IV antibiotics and continued po abx upon d/c. D/C when afebrile x48hrs and labs improved.					Y	4			U	09/18/2008	09/18/2008	0	see Dr's office. Labs and Diagnostics:  CBC with WBCs 26.9K up to 38.7-52% neutros, 28.5% lymphs, 14.1% monos, platelets 535K. UA with 2+ bacteria and 10-15 WBCs, 5-10RBCs, nitrate (+).  Renal US (+) for mild dilitation of the R collecting system. UC(+) for >100K E. coli. Blood cx (-).	UNK	UNK		None	None. PMH:  none. NKDA.	none~ ()~~0.00~In Patient|none~ ()~~0.00~In Sibling		1						1	Abdominal pain; Abnormal behaviour; Catheter placement; Crying; Cystitis; Kidney infection; Pain; Pyrexia; Rash generalised; Screaming; Urine analysis; Vomiting; White blood cell count increased	DTAPIPVHIB~SANOFI PASTEUR~C3178AA~3~IM~LA~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~U72782EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C63110~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0469X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0330158	10/27/2008	NC	23.0	23		F	10/27/2008	Acne type rash spread from chest to neck, face and back. Given Kelfex, Medrol Dosepak and Benadryl.				Y					U	10/23/2008	10/24/2008	1		UNK	PVT						1						1	Dermatitis acneiform	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0330161	10/27/2008	NY	71.0	71		M	10/27/2008	About six hours after the annual flu shot I woke up with severe chills, then sweats with diarrahea, and a momentary fainting, then worse chills. Felt like a bad case of the flu. Then, blessedly, a nice sleep. Whole thing lasted less than two hours. Tired, a little weak, but better the next day. No continuing reactions. Not sure which Sanofi Pasteur vaccine it was.									Y	10/23/2008	10/24/2008	1	NA	UNK	PUB	Crestor, Cialis, Ambien	no	none			1						1	Asthenia; Chills; Diarrhoea; Fatigue; Hyperhidrosis; Influenza like illness; Syncope	FLU3~SANOFI PASTEUR~do not know~7+~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330163	10/27/2008	MI	22.0	38		F	10/27/2008	HPV Vaccine - Incorrect interval between doses. Patient had stated this was second dose but this was the third dose.									Y	10/27/2008	10/27/2008	0	None	PVT	UNK	Nuvaring, Prozac, Vatrex	No	migraines, Depression			1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U2767AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0548X~3~IM~RA~HPV (GARDASIL)~1	USA		Influenza
0330165	10/27/2008	KY	17.0	17		F	10/27/2008	30 minutes following administration patient suffered vomiting.  Vomiting was severe and she had swelling of eyelids and peticheae surrounding eyes.  She also reported HA.				Y					U	10/27/2008	10/27/2008	0		PVT	PVT	Orthotricyclen, allegra	none	seasonal allergies			1						1	Eyelid oedema; Headache; Petechiae; Vomiting	FLU3~SANOFI PASTEUR~42749AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330166	10/27/2008	IN	65.0	65		F	10/27/2008	4 hours after patient received vaccine she had symptoms of memory loss and weakness.  She went to ER where they could find no problems, only that her blood sugar was a little low.  The Dr there thought it was not related to vaccine and may be related to hypoglycemic episode.									Y	10/16/2008	10/16/2008	0	At ER.  Blood Work, EKG.	UNK	UNK						1						1	Amnesia; Asthenia; Blood glucose decreased; Blood test; Electrocardiogram; Amnesia; Anxiety; Dizziness; Electrocardiogram; Full blood count; Laboratory test; Paraesthesia; Paraesthesia oral	FLU3~CSL LIMITED~02349111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|FLU3~CSL LIMITED~33332000801~1~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~2	USA		Influenza
0330167	10/27/2008	GA	44.0	44		F	10/27/2008	Employee was given 2 IM shots in Left deltoid flu shot & tdap vaccine. Employee came in on 10/24/2008 stating that 2days after the vaccine was given to her,she experienced nausea, headache & dizziness. She was then referred to Dr. for evaluation.									Y	10/13/2008				UNK	UNK		none	none			1						1	Dizziness; Headache; Nausea	DTAP~SANOFI PASTEUR~C3029AA~1~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2764AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0401X~1~IM~RA~HEP B (RECOMBIVAX HB)~1	USA		Influenza
0330168	10/27/2008	TX	63.0	63		F	10/27/2008	PATIENT CALLED MORNING AFTER AND SHE BROKE OUT IN HIVES ON HER ABDOMEN AND WAS ITCHING.  NO OTHER SYMPTOMS REPORTED BY PATIENT.  PATIENT INSRUCTED TO TAKE BENADRYL OTC.									Y	10/24/2008	10/25/2008	1		UNK	UNK	UNKNOWN	NONE REPORTED	NONE REPORTED			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2761AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330169	10/27/2008	PA	9.0	9		M	10/27/2008	On 10/27/08, at another visit, the patient's mother reported that the varicella injection site had grown to approx. 10-12 cm. There was redness to the area and there was not any pain associated with this.  On 10-27-08 the physician noted that the swelling was remarkably smaller, approx. 1-2 cm, with minimal redness.									Y	10/23/2008	10/23/2008	0	None.	PVT	PVT		Sinusitis	Asthma			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2754AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1140x~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0330170	10/27/2008	KY	28.0	28		F	10/27/2008	Pass out and vomit, blurry vision				Y					U	10/27/2008	10/27/2008	0		UNK	UNK		no	no known			1						1	Loss of consciousness; Vision blurred; Vomiting	FLU3~CSL LIMITED~01849111a~2~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0330172	10/27/2008	TN	35.0	35		F	10/27/2008	Pt diagnosed with Neuritis. Pt complains of burning sensation on trunk of body. Symptoms started approx. 4 days after having flu immunization.				Y					Y	10/20/2008	10/24/2008	4		PVT	PVT						1						1	Burning sensation; Neuritis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA156AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0330173	10/27/2008	CA	50.0	50		F	10/27/2008	Pt had flu like symptoms the day following a combination of fluvirin and pneumovax given on Oct 21, 2008, both in the right arm.  Her flu like symptoms were aches/pains, fever, chills.  2 days following the vaccines, she presented to her MD with swollen lymph nodes on her right side that were both visible and swollen to touch according to the patient.  1 week after receiving the vaccines, she has no symptoms and is feeling back to normal.  Patient has had previous Flu vaccines in past.  This is her 1st pneumonia vaccine.				Y					Y	10/21/2008	10/22/2008	1	PE on physician office.	UNK	UNK	omeprazole 20 mg	none	codeine allergy			1						1	Chills; Influenza like illness; Lymphadenopathy; No reaction on previous exposure to drug; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89620~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0990u~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0330175	10/27/2008	VA	0.92	0	1	F	10/27/2008	Fussiness and fever following, then 2 minute febrile seizure- generalized tonic clonic. Spontaneous recovery after postictal period with no complications				Y					Y	10/24/2008	10/24/2008	0		PVT	PUB		URI with cough	mild persistent asthma			1						1	Febrile convulsion; Grand mal convulsion; Irritability; Postictal state; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B090AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2787CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF201AB~3~IM~LL~HIB (PROHIBIT)~1|PNC~PFIZER\WYETH~C69205A~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0330176	10/27/2008	AZ	6.0	6		F	10/27/2008	10-27-08 telephone call from childs Mother.  She states on 10-20-08, child developed hives on his back and arms. No fever and no resp. distress at this time.  Child was seen by school nurse the next day.  RN (school nurse) reports hives were on back, stomach, arms, legs and neck.  Mom was notified and picked child up from school.  Mom took child to Emergency room immediately.  States child had a little wheezing.  Benadryl administered by ER staff.  Mom told ER staff about previous vaccinations but states they were uncertain of what may have caused the hives. Benadryl was administered to child at E.R. Hives got better after 24 hours. Hives returned next day, child was taken back to E.R. and Benadryl administered again. Hives resolved as of 10-26-08.  Neither time the E.R. could determine cause of illness, per Mom.				Y					Y	10/15/2008	10/20/2008	5	none	UNK	UNK	none	none	none			1						1	Urticaria; Wheezing	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B103AC~5~IM~LA~DTAP + IPV (KINRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500550P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~MERCK & CO. INC.~0414U~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0330177	10/27/2008	AR	8.0	8		F	10/27/2008	Once patient got down from the exam bed, patient's equilibrium was completely off sending her straight into a door jamb.  She then fell to the ground of the clinic and passed out for a few seconds.  Became very pale and stayed extremely dizzy.  Blood pressure was good, but heart rate was only 58 beats per minute.  911 was called and the paramedics did a heart monitor test on her, which was normal.  Once the dizziness passed (about 30 minutes), she was able to walk on her own, but was weak, felt sick and had no energy for most of the rest of the day.									Y	10/24/2008	10/24/2008	0		UNK	UNK	none	none	none			1						1	Asthenia; Balance disorder; Blood pressure normal; Dizziness; Fall; Loss of consciousness; Malaise; Pallor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89970~4~ID~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330179	10/27/2008	MI	55.0	55		F	10/27/2008	WAS IN GOOD HEALTH AT TIME OF INTRAMUSCULAR ADMINISTRATION OF INFLUENZA VACCINATION ON 10/13/08 AT RIGHT DELTOID. PAIN OVER RIGHT DELTOID ALMOST IMMEDIATELY AFTER ADMKNISTRATION.  PERSISTENT PAIN.  PAIN EXACERBATES WHEN ELEVATING RIGHT ARM > 90 DEGREES, LIFTING ANY OBJECT.  DIFFICULTY COMPLETING ADLS.  NO ERRYTHEMA, INDURATION.  NO RELIEF WITH NSAIDS, WARM MOIST HEAT, ICE.  WILL TREAT WITH FLEXERIL AND PHYSICAL THERAPY.									U	10/13/2008	10/13/2008	0		PVT	PVT	ALLEGRA, BONIVA, CYMBALTA, DYAZIDE, SIMVASTATING, SYNTHROID, CALCIUM, CITRACAL, NEXIUM	NONE	BACTRIM			1						1	Activities of daily living impaired; Immediate post-injection reaction; Injected limb mobility decreased; Injection site pain; Induration; Pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2757AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2757AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|TDAP~SANOFI PASTEUR~C2768BA~UNK~UN~LA~TDAP (ADACEL)~2	USA		Influenza
0330180	10/27/2008	WI	90.0	90		F	10/27/2008	Extreme overall body pain lasting for about 2 hours. She never complains of overall body pain. She cried very hard during the pain - I've never seen her react to anything like this.									Y	10/24/2008	10/24/2008	0	None	UNK	PUB		Chromic Leukemia, dimentia, macular degeneration, severe arthritus, congestive heart failure.		unknown~ ()~NULL~~In Patient		1						1	Crying; Pain	FLUX~UNKNOWN MANUFACTURER~no info - PPV~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330181	10/27/2008	AZ	25.0	25		F	10/27/2008	The patient received the Flumist at 1430 HRS and went to exercise immediately.  At around 1525 HRS, the patient experienced facial swelling with no difficulty breathing.  The patient went back to the clinic and was treated with Epinephrine, prednisone and benadryl. The patient was released to go home with prescribed after an hour.									N	10/14/2008	10/14/2008	0		MIL	MIL	Allegra	None	None			1						1	Swelling face	FLUN3~MEDIMMUNE VACCINES, INC.~500557P~4~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0330182	10/27/2008	TN	54.0	54		F	10/27/2008	fever,swollen lymp node's in neck, arm and arm pit area hurt real bad, body aches									Y	10/06/2008	10/06/2008	0		UNK	UNK						1						1	Axillary pain; Lymphadenopathy; Pain; Pain in extremity; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua364ba~2~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330183	10/27/2008	PA	64.0	64		F	10/27/2008	Twenty four hours after receiving the pneumonia vaccine my arm began to hurt, swell, skin around injection site turned very red and hot to the touch.  I became very sick, was in bed the full day except to go to the bathroom on the second day after receiving the vaccine.  A lump is also at the injection site.  I was told to use ice for 15 minutes, then off for 15 minutes.  I continued this for the entire weekend, every few hours.  On the following Monday I returned to the doctor, was put on antibiotics and benydryl.  The arm is still slightly red, and the lump at the injection site is still there.				Y					Y	10/15/2008	10/16/2008	1		UNK	UNK	Effexor XL    Ativan  Chantix	None	None			1						1	Injection site erythema; Injection site mass; Injection site warmth; Malaise; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IJ~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0330203	10/27/2008	TX	90.0			M	10/27/2008	Medical history included no adverse events following receipt of previous influenza virus vaccine and  no adverse events following receipt of previous unspecified vaccinations. The subject received no other vaccinations on the day of the FLULAVAL administration. This case was reported by a healthcare professional and described the occurrence of stiff neck in a 90-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received 1st dose of FLULAVAL (.5 ml, unknown). Within hours of vaccination with FLULAVAL, the subject experienced stiff neck and restricted neck movement. The healthcare professional considered the events were disabling. At the time of reporting the outcome of the events were unspecified. The healthcare professional (a pharmacy coordinator) reported that a 90 year old male received FLULAVAL and the next morning reported neck stiffness. this required him to move his head with his hands, he could not  turn his neck. The dates of administration and onset were not known at the time of this report. Caller reports that the subject will be, if he hasn't already seen, a Chiropractor.								Y	U				UNK	PUB	OTH		Unknown	Medical history included no adverse events following receipt of previous influenza virus vaccine and no adverse events following receipt of previous unspecified vaccinations.		A0753761A	1						1	Hypokinesia; Musculoskeletal stiffness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA171AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Disabling	Influenza
0330204	10/27/2008	CA				M	10/27/2008	This case was reported by a healthcare professional via a sales representative and described the occurrence of rash in an adult male subject who was vaccinated with FLUARIX (GlaxoSmithKilne). On 7 October 2008 the subject received a dose of FLUARIX at 0.5 ml. On 7 October 2008, and into the next day, the subject developed a generalized itchy rash. On 11 October 2008, four days after vaccination with FLUARIX, the subject developed hives and was seen in the emergency room. He was hospitalized overnight and diagnosed with shingles. On 21 October 2008, the events of rash, hives and itching were resolved. The healthcare professional considered these events and shingles unrelated to vaccination with FLUARIX. Similar events occurred in three additional subjects. Linked case include: A0753769A, A0753770A and A0753771A.				Y	Y	1			U	10/07/2008	10/07/2008	0	UNK	OTH	OTH		Unknown	The subject had no known history of adverse events following previous vaccinations. Similar events occurred in three additional subjects. Linked cases include: A0753769A, A0753770A and A0753771A.		A0753760A	1						1	Herpes zoster; Rash generalised; Rash pruritic; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA381BA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0330205	10/27/2008	MI	34.0	34		M	10/27/2008	This case was reported by a physician and described the occurrence of aseptic meningitis in a 34-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In October 2008 (approximately two weeks prior to reporting) the subject received unspecified dose of FLULAVAL (unknown). On 11 October 2008, within weeks of vaccination with FLULAVAL, the subject was admitted to the hospital with severe headaches that were worse on movement, vomiting and a fever of 100F. He had a CT scan and a spinal tap. He was treated for 24 hours with ROCEPHIN. Aseptic meningitis was reported. The physician considered the events were clinically significant (or requiring intervention). The subject improved and was discharged on 13 October 2008. He was seen by his physician on 17 October 2008 and was given a prescription for pain relievers for the headache symptoms. At the time of reporting the events were resolved. THE subject returned to work on 22 October 2008.				Y	Y	3			Y	10/01/2008	10/11/2008	10	Body temperature, 100F. The subject underwent a CT scan and a spinal tap on an unknown date. Results were not reported.	OTH	OTH		Unknown			A0753735A	1						1	Body temperature increased; Computerised tomogram; Headache; Lumbar puncture; Meningitis aseptic; Pyrexia; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation	Influenza
0330206	10/27/2008	AL	60.0			F	10/27/2008	This case was reported by a healthcare professional and described the occurrence of syncope in a 60-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included JUVEN, VITAMIN B3, LUCIDRIL, OMEGA 3 FISH OIL, LEXAPRO, AMBIEN, VITAMIN E, VITAMIN C, MAXIDEX, multivitamins plus zinc, LEUCINE, Folic Acid, BONIVA, CITRACAL and unspecified eye drops. On 20 October 2008 the subject received a dose of FLULAVAL at 0.5 ml in an unknown deltoid. On 20 October 2008, 30 minutes after vaccination with FLULAVAL, the subject experienced syncope. Additionally, standing at the counter, the subject felt as though she was going to faint. She fell and fainted and hit her head as she fell. It was not reported how long the subject was out. At the time of reporting syncope was improved. The healthcare professional considered the event of syncope probably related to vaccination with FLULAVAL. A statement in the text of the report read: The cold packs were not frozen upon delivery. Tag alert indicated that the product was okay. Days later at room temperature, the Tag Alert still says okay.									U	10/20/2008	10/20/2008	0	UNK	PVT	PVT	JUVEN; NICOTINIC ACID; MECLOFENOXATE HCL; OMEGA-3 MARINE TRIGLYCERID; LEXAPRO; ZOLPIDEM TARTRATE; VITAMIN E; ASCORBIC ACID; DEXAMETHASONE; MULTIVITAMINS + ZINC; LEUCINE; FOLIC ACID; IBANDRONATE SODIUM; CALCIUM CITRATE; EYE MEDICATION (unspe	Unknown	The subject has no relevant medical history and no history of reactions following previous flu shots.		A0753607A	1						1	Dizziness; Fall; Head injury; Syncope	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA208AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0330207	10/27/2008	AL	64.0			F	10/27/2008	This case was reported by a healthcare professional and described the occurrence of syncopal attack in a 64-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included Calcium Supplements, TYLENOL, ZOCOR, BONIVA, COUMADIN, ALLEGRA and MIRALAX. On 20 October 2008 the subject received a dose of FLULAVAL at 0.5 ml in an unknown deltoid. On 20 October 2008, 30 minutes after vaccination with FLULAVAL, the subject experienced a syncopal episode. The healthcare professional considered the event was life threatening and clinically significant (or requiring intervention). At the time of reporting the outcome of the event was improved. The healthcare professional considered the event was probably related to vaccination with FLULAVAL. A statement in the text of the report read: The cold packs were not frozen upon delivery. Tag alert indicated that the product was okay. Days later at room temperature, the Tag Alert still says okay. Monitored in the emergency room and released.			Y	Y					N	10/20/2008	10/20/2008	0	UNK	PVT	PVT	Calcium salt; Paracetamol; Simvastatin; Ibandronate sodium; Warfarin sodium; Fexofenadine hydrochlorid; Polyethylene glycol	Unknown	CEREBRO VASCULAR DISEASE. The subject has no history of reactions following previous flu shots.		A0753606A	1						1	Syncope	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA208AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening	Influenza
0330208	10/27/2008	AL	79.0			F	10/27/2008	This case was reported by a healthcare professional and described the occurrence of seizure in a 79-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included XYZAL, SYNTHROID, SIMVASTATIN, NYSTAN, ZYMAX, NEXIUM, IMDUR, GLUCOPHAGE, COZAAR, ALDACTONE, ACTOS, METAMUCIL, GLUCOSAMINE CHONDROITIN, ASPIRIN and CENTRUM SILVER. On 20 October 2008 the subject received a dose of FLULAVAL at 0.5 ml in an unknown deltoid. On 20 October 2008, at an unspecified time after vaccination with FLULAVAL, the subject experienced seizure. The healthcare professional considered the event was disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with FLULAVAL.			Y	Y				Y	U	10/20/2008	10/20/2008	0	UNK	PVT	PVT	Levocetirizine HCl; Thyroxine sodium; SIMVASTATIN; NYSTATIN; Diet medication; Esomeprazole; Isosorbide mononitrate; Metformin hydrochloride; Losartan potassium; Sprinolactone; Pioglitazone; Psyllium husk; Glucosamine chrondroitin; Aspirin;	Unknown	The subject has no relevant medical history. The subject experience mild erythema following flu vaccine the previous year (vaccine may not have been GlaxoSmithKline vaccine).		A0753600A	1						1	Convulsion; Asthenia; Chest X-ray; Drooling; Electrocardiogram; Hyperhidrosis; Hypoglycaemia; Scan brain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA208AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA208AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~2	USA	Life Threatening,Disabling	Influenza
0330211	10/27/2008	WI	86.0	86		F		Weakness of legs and arms so she could not get up from chair or walk with walker about 5 hours after the shot. Improved in hospital. Low grade fever, treated with IV fluids. 12/1/08-records received for DOS 10/13-10/15/08-DC DX: fever, likely secondary to vaccination, resolved. Unsteady gait, multifactorial, likely from atherosclerotic cerebrovascular disease and multiple infarcts. Presented with C/O weakness and fever.				Y	Y	2			Y	10/13/2008	10/13/2008	0	12/1/08-records received- Echocardiogram showed mild worsening of underlying aortic stenosis.	PVT	UNK		12/1/08-records received-Weakness in both legs which has been going on for a couple of months along with low grade fever and fatigue.	12/1/08-records received-PMH:Congestive heart failure. Atrial fibrillation. Diabetes mellitus type 2. Chronic kidney disease stage III, hypothyroidism, hypertension, history of gastritis, chronic anticoagulation with Coumadin for atrial fibrillation. Depression with anxiety. Gallstone pancreatitis. Cardioversion.			1						1	Abasia; Dysstasia; Pyrexia; Walking aid user	FLU3~SANOFI PASTEUR~U2805AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0330212	10/27/2008	CA	48.0	48		F	10/27/2008	Swollen lips, chest pain.  Treated at hospital 10/21-10/23, see MD report, he was supposed to send a VAERS. 12/17/08-records received for DOS 10/22-10/23/08-DC DX: Likely acute allergic reaction to Flu shot, resolved. Dyslipidemia. Leukocytosis. Admitted with throat swelling, lip swelling, difficulty breathing. Also ate shrimp on same day.				Y	Y	1			Y	10/21/2008	10/21/2008	0	See MD report 12/17/08-records received-Cholesterol 263, triglycerides 91, HDL 81 and LDL 164. BNP normal CBC normal except for white count of 12.3. Troponins negative times 2. EKG normal.	UNK	PUB	? V MD report		? Heart conditions 12/17/08-records received-PMH: CAD status post ST elevation MI last year. Mitral valve prolapse.  Hypertension. PTCA.			1						1	Chest pain; Lip swelling	FLU3~SANOFI PASTEUR~U2765AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0330213	10/27/2008	FL	7.0	7		F	10/24/2008	24 hours after shot child with wheals through at skin, arms, legs, abdomen pruritic.									Y	10/23/2008	10/23/2008	0	Non so far	PVT	PVT	Benadryl	Urticaria	Atopic Dermatitis			1						1	Rash pruritic; Urticaria	FLU3~SANOFI PASTEUR~U2811AA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330214	10/27/2008	ND	60.0	60		M	10/27/2008	After receiving a Zostavax vaccine, left arm became reddened, swollen from elbow to shoulder.  Developed low grade fever, chills, aching.  Arm was warm to touch.  On 4th day after shot redness and swelling improved.									Y	10/23/2008	10/24/2008	1	None	PVT	PVT	CRESTAR 5 mg	None	History prostate cancer; mild emphysema.			1						1	Chills; Erythema; Injection site swelling; Pain; Pyrexia; Skin warm	FLU3~SANOFI PASTEUR~U2742AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~1~UN~LA~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~1207X~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0330215	10/27/2008	TX	65.0	65		M	10/27/2008	3 pm: Patient complaint - fast heartbeat and dizziness. Patient advised to go to ER via 911. Patient stated he would go via bus.				Y					U	10/27/2008	10/27/2008	0	None performed	OTH	PVT	Aspirin	Unknown	Unknown			1						1	Dizziness; Heart rate increased	FLU3~SANOFI PASTEUR~U2833AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330216	10/27/2008	IN	54.0	54		F	10/27/2008	Vaccine administered to (L) delt 10/13/08. Had progressive atrophy at injection site beginning 10/23/08.				Y					N	10/13/2008	10/24/2008	11		PVT	UNK		None	Depression; Allergic rhinitis; Nasonex; Zomig; Xanax			1						1	Injection site atrophy; Injection site atrophy	FLU3~SANOFI PASTEUR~U2789CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2789C~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0330217	10/27/2008	MA	43.0	43		F	10/17/2008	C/O burning in throat, feeling of swelling to tongue, numbness in both legs below the knees, dizziness diaphoretic. No respiratory distress. Taken by ambulance to Emergency dept. Treated with Benadryl, Solu-Medrol and Zantac.				Y					Y	10/16/2008	10/17/2008	1	None	OTH	PVT	None	None noted	Allergy to IV dye			1						1	Dizziness; Hyperhidrosis; Hypoaesthesia; Swollen tongue; Throat irritation	FLU3~SANOFI PASTEUR~U2764AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330218	10/27/2008	PA	52.0	52		F	10/23/2008	S.O.B. & pain under breast after flu shot hurt to take deep breaths. Tachycardia - dizzy & lightheaded within 15 mins after flu shot. ER via EMS.				Y					U	10/23/2008	10/23/2008	0		PVT	UNK			Medical Tape / ?Benadryl			1						1	Breast pain; Dizziness; Dyspnoea; Tachycardia	FLU3~SANOFI PASTEUR~U2786CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330219	10/27/2008	TN	0.72	0	.7	M	10/27/2008	Rash on face around mouth up to eye. Rash worsening to rest of body.				Y					U	10/23/2008	10/24/2008	1		PVT	PVT		Rash; Insect bite on (L) cheek	Cleft lip, cleft palate			1						1	Rash; Rash generalised	FLU3~SANOFI PASTEUR~UT2792DA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330220	10/27/2008	NJ	83.0	83		M	10/22/2008	12/17/ (L) arm swelling, wrist to elbow, red/tender to touch, warm, injection site at intermittent/nontender. Tx CLARITHROMYCIN 500 bid x 7d R-O All PCN				Y					Y	10/14/2008	10/14/2008	0		PVT	PVT		COPD				1						1	Injection site erythema; Injection site pain; Injection site warmth; Oedema peripheral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA151AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0551X~2~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0330221	10/27/2008	NY	4.0	4		F	10/27/2008	? site has lg red circle -> Advised to apply cool compress and make take TYLENOL for discomfort									U	10/07/2008	10/10/2008	3		PVT	PVT	None	None	None			1						1	Discomfort; Injection site erythema	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B085BA~4~IM~LA~DTAP (INFANRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500551P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~A1109~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0330222	10/27/2008	NJ	75.0	75		F	10/22/2008	Erythema and swelling of right arm (away from injection site).				Y					Y	10/21/2008	10/21/2008	0		PVT	PVT		Lung cancer				1						1	Erythema; Oedema peripheral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA151AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0551X~2~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0330223	10/27/2008	MA	4.0	4		M	10/24/2008	Given vaccines by myself.  When walking down hall a couple minutes later, complained of itching.  Brought back to exam room.  Covered in confluent hives, eyes and ears puffy.  Benadryl given.  Oz Sat 95%, RA briefly then 99% RA.  Never wheeze.  A few coughs after receiving Benadryl resolved.  Taken via EMS to hospital ED, where received steroids, Epi pen Jr, monitored.  Discharged home with 5 day course of steroids.				Y					Y	10/24/2008	10/24/2008	0		PVT	UNK		Mild URI; No fever	None			1						1	Auricular swelling; Cough; Eye swelling; Oxygen saturation decreased; Pruritus; Urticaria	DTAP~SANOFI PASTEUR~U2355BA~5~IM~RA~DTAP (TRIPEDIA)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500563P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~A0474~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1926U~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0330226	10/27/2008	MA	10.0	10		M	10/23/2008	Local inflammation/soreness at site right deltoid.									U	10/20/2008	10/20/2008	0		PUB	UNK		None	Amoxicillin allergy			1						1	Inflammation; Pain in extremity	FLU3~SANOFI PASTEUR~U2828AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0531X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0330229	10/27/2008	IN	44.0	44		F	10/27/2008	Arthralgias ankles, knees, hips, hands, great toe and mild welling ankles.									Y	10/15/2008			Sed rate elevated 48	UNK	UNK		None	None			1						1	Arthralgia; Joint swelling; Red blood cell sedimentation rate increased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA350CA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330231	10/27/2008	IL	4.0	4		M	10/22/2008	Mom called and reported child ran slight fever for 8 hours and then 35 hours after receiving vaccine child developed a rash from breast bone to umbilicus.  Lasted for 2 days.									Y	10/16/2008	10/16/2008	0		PUB	PUB	None	No	None			1						1	Pyrexia; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500558P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0330232	10/27/2008	MD	25.0	25		F	10/27/2008	Area the following day way raised, bright red extended for 2 inches around site. Skin surface was raised about 1/4 inch. 2 days later rim of color extended 4 inches from site.									Y	10/24/2008	10/25/2008	1	None	OTH	PVT		None	Penicillin Allergy			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2833AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330233	10/27/2008	FL	72.0	71		F	10/27/2008	Patient fainted Approx 10 minutes after vaccine. Paramedics in store - transported to hospital.				Y					U	10/27/2008	10/27/2008	0		OTH	PVT	Not at our store	None				1						1	Syncope	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA157AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0330239	10/27/2008	TX	65.0	65		F	10/12/2008	Patient received FLUVIRIN (Novartis) and PNEUMOVAX 10/03/2008 at 15:58. Her temperature was 103.5 on 10/4 with extreme dizziness. She saw Dr. 10/7. Dr reported to me that she had temp of 102.5, dizziness and 2nd degree cellulitis at site. He prescribed Cipro 500 twice a day for 10 days. On 10/12 patient reported to me she was better, still running a low-grade temperature and still very weak but no dizziness. Dr's phone number is 325 690 1500.				Y						10/03/2008	10/04/2008	1	None	OTH	OTH	ASA	No	None			1						1	Asthenia; Body temperature increased; Dizziness; Injection site cellulitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89884~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~8551X~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0330240	10/27/2008	NE	70.0	70		F	10/27/2008	Welt appeared later same day. Pt self medicated w/50 mg Benadryl; applied ice tx. No further reaction.									Y	10/23/2008	10/23/2008	0	None	UNK	PVT	None	None	None			1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0867X~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330241	10/27/2008	GA	2.0	2	.1	M	10/24/2008	FLUMIST given to 2 y.o. male with history of asthma. Patient had wheezing that started prior to visit 10/22/08. Mother treating at home with albuterol. On day of visit, patient was clear to auscultation on exam. Patient was accidentaly given FLUMIST instead of FLUZONE. There was no immediate wheezing following FLUMIST, and prior to patient leaving office.										10/22/2008	10/23/2008	1		PVT	UNK		asthma; wheezing	asthma			1						1	Wrong drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500545P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB297CA~2~IM~LL~HEP A (HAVRIX)~1	USA		Influenza
0330242	10/27/2008	WI	43.0	42		F	10/24/2008	Rash, pain, swelling, redness - size of tennis ball - given SQ in rt arm flu shot given in rt arm deltoid.									Y	10/20/2008	10/21/2008	1	None	PVT	UNK	Advair; Diskus; Xopenex; Kyzal; Lisinopril; Fexofenadine; Nasonex; Imitrex	None	None			1						1	Erythema; Pain; Rash; Swelling	FLU3~CSL LIMITED~01249111A~2~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~1224U~1~SC~RA~PNEUMO (PNEUMOVAX)~1|TTOX~SANOFI PASTEUR~U2332AA~2~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0330244	10/27/2008	NY	59.0	59		M	10/27/2008	Fever, nausea, scratchy throat, weakness. Constant cough, wheezing.									N	10/20/2008	10/22/2008	2		OTH	UNK	Cozaar, HTZ - Pletal	None	None			1						1	Asthenia; Cough; Nausea; Pyrexia; Throat irritation; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0329416	10/28/2008	TX	60.0	60		M	10/21/2008	Reason for admission - received flu shot 10-18-08 at approximately 0815, came to Emerg Dept on 10-18-08 at 1645 c/o itching and rash, was given Benadryl 50mg IM at 1758; returned to Emerg Dept 10-19-08 at 1038 w/ complaints of rash all over body and blisters and whelps, was given Solumedrol 125 IM and Vistaril 50mg IM; Returned 10-20-08 to Emerg Dept w/ complaints of CP mid/lt sternal on a scale of 8/10 along with lightheadedness and SOB; reports on admission that he is pain free but rash and blisters are returning. The Pt was admitted due to his hx of CAD, but it is felt he had an anxiety reaction to his continuing circumstances, as his chest pain resolved quickly upon admission without any actual treatment of the chest pain itself.					Y				U	10/18/2008	10/18/2008	0		UNK	UNK	Diphenhydramine; Methylprednisolone; Hydroxyzine		Hx CAD; unstable angina; HTN; Hyperlipidemia; GERD; anxiety; Meniere's Disease			1						2	Anxiety; Blister; Chest pain; Condition aggravated; Dizziness; Dyspnoea; Pruritus; Rash; Rash generalised; Urticaria; Anxiety; Blister; Chest pain; Condition aggravated; Dizziness; Dyspnoea; Pruritus; Rash generalised; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA174AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA174AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Hospitalisation	Influenza
0329430	10/28/2008	MN	54.0	54		F	10/22/2008	(Per patient) 6 pm, flu shot. 9 pm same day, hives right flank. 12:00 am next morning, throat closing off. Called 911. Took to ER. IV Benadryl, oral prednisone. Discharged at 5 am 10-16-08.			Y	Y					Y	10/15/2008	10/16/2008	1		PVT	PVT	Unknown	None	Unknown	Hives fever~Influenza (Seasonal) (no brand name)~UN~48.00~In Patient		1						2	Dysphagia; Dyspnoea; Pharyngeal oedema; Urticaria; Throat tightness; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~2	USA	Life Threatening	Influenza
0329858	10/28/2008	WA	4.0	4		M	10/22/2008	tactile fever, Vomiting X 1									Y	10/21/2008	10/22/2008	1	N/A	PVT	PUB	Zyrtec, Singulair, Veramist	None	None			1						2	Pyrexia; Vomiting; Pyrexia; Vomiting	DTAP~SANOFI PASTEUR~C2955BA~5~IM~RL~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500567P~1~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~A0492~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0812X~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0989X~2~SC~RL~VARICELLA (VARIVAX)~1|DTAP~SANOFI PASTEUR~C2955BA~5~IM~RL~DTAP (DAPTACEL)~2|FLUN3~MEDIMMUNE VACCINES, INC.~500567P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|IPV~SANOFI PASTEUR~A04922~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~2|MMR~MERCK & CO. INC.~~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~2|VARCEL~MERCK & CO. INC.~0989X~2~SC~RL~VARICELLA (VARIVAX)~2	USA		Influenza
0330186	10/28/2008	OK	9.0	9		F	10/28/2008	hoarse, fever, severe congestion, pale, weak, vomitting excess mucus; ARNP prescribed Rondec cough syrup and is taking OTC motrin & tylenol									Y	10/24/2008	10/25/2008	1	none	PVT	UNK	Miralax, Singulair, Mannatech products	None	Down Syndrome, Cerebral Palsy, hip displasia, Gtube, Sleep Apnea  ALLERGIC TO:  PCN, Atropine, Atarax, Betadine, Latex			1						1	Asthenia; Dysphonia; Pallor; Pyrexia; Upper respiratory tract congestion; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330265	10/28/2008	NM	33.0	33		F	10/10/2008	Approx 4 hours post receiving vaccine - malaise, fatigue, and fever set in. Soon severe burning and redness of both eyes, severe headache. Periorbital swelling and mouth swelling, facial numbness and tingling also manifested. Seen by provider. Reversed effect - IM 50 mg of Benadryl. 12/19/08-records received-10/10/08 allergic reaction to flu shot with oral edema and numbness.									U	10/10/2008	10/10/2008	0		UNK	UNK			NKDA; no other allergies lifetime			1						1	Eye irritation; Eye swelling; Fatigue; Headache; Hypoaesthesia facial; Malaise; Ocular hyperaemia; Oedema mouth; Paraesthesia; Pyrexia	FLU3~SANOFI PASTEUR~U2748AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330269	10/28/2008	IL	76.0	76		F	10/23/2008	Pt's daughter called on 10/22/ regards to her mother's vaccinations. She stated that her mother's left arm is 3 x normal size. It is very swollen and painful. She also has high fever. I recommended to apply some ice and given her MOTRIN or TYLENOL, and see PCP. But, she was very upset and stated that she is the nurse, and this is not normal reaction to the vaccine. She wanted Rph name who gave vaccination.									U	10/21/2008	10/22/2008	1		OTH	PUB			None			1						1	Oedema peripheral; Pain in extremity; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~05518~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330270	10/28/2008	LA	6.0	6		M	10/22/2008	(R) deltoid area swollen and tender no fever to touch									Y	10/20/2008	10/21/2008	1		PVT	PUB	None					1						1	Injection site pain; Injection site swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~C2958AA~5~SC~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2797DA~1~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330271	10/28/2008	IL	38.0	38		F	10/23/2008	Patient called and wanted RPN name, who gave vaccinations.  She was very upset.  She stated that her left arm was swollen and is very painful to the point where she could not sleep for past 9 nights.  The pain also started to radiate from her arm to shoulder, neck and back.  She cannot move her hand, neck or turn due to pain.  Her husband is a physician, and he thinks that the RPN might have hit a blood vessel and patient is bleeding internally.  Patient states that the area is very red and there are spots around which are also red.									U	10/21/2008	10/23/2008	2		OTH	PUB			None			1						1	Back pain; Erythema; Insomnia; Mobility decreased; Musculoskeletal pain; Neck pain; Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89801~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~05518~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330272	10/28/2008	AZ	50.0	50		F	10/24/2008	30 min after shot ches became heavy, throat seemed thick itchyness. Called doctor, he told her to take BENADRYL. Still feels strange-also recently had allergic reaction to peanuts and pecans.									Y	10/05/2008	10/05/2008	0	None	PUB	PVT	None	None	None			1						1	Chest discomfort; Pruritus; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~A158AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0330274	10/28/2008	FL	37.0	37		F	10/20/2008	Immediate itching at site, then perioral itching, numbness, not feeling right, hypotension.				Y					Y	10/04/2008	10/04/2008	0		PVT	PVT	BCP; Benadryl	No				1						1	Feeling abnormal; Hypoaesthesia oral; Hypotension; Immediate post-injection reaction; Injection site pruritus; Pruritus	FLU3~SANOFI PASTEUR~U2762AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330275	10/28/2008	CA	4.0	4		F	10/15/2008	Pt fainted per mom after receiving vaccines									Y	10/15/2008	10/15/2008	0		PVT	PVT						1						1	Syncope	DTAP~SANOFI PASTEUR~C2935AA~5~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2808AA~4~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0805~2~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0665X~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~02727~2~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0330276	10/28/2008	MD	76.0	76		F	10/22/2008	Hoarse throat - several hours, headache - 48 hours									Y	10/15/2008	10/15/2008	0		OTH	PUB	CRESTOR; KEPPA					1						1	Dysphonia; Headache	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330277	10/28/2008	WA	64.0	64		F	10/15/2008	When I got up the morning after the flu shot, I was extremely clammy, sweating, and nauseous.  I vomited several times.  Throughout the day, I remained light headed and periodically clammy, then hot and cold.  I stayed in bed all day, not eating anything until evening.  The next day I was okay.									Y	10/08/2008	10/09/2008	1	None	PVT	PVT	LOMATADINE 10mg; SYNTHROID .075mg; SINGULAIR; LOVASTATIN; NEXIUM 40mg; RHINOCORT AQ	None	Hashimotos Thyroidites.  Many allergies.  Have been getting allergy shots for 6 1/2 years.  I have asthma and chronic rhinitis.  I am not allergic to eggs.			1						1	Cold sweat; Dizziness; Feeling of body temperature change; Hyperhidrosis; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U2756AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330278	10/28/2008	CA	4.0	4		M	10/21/2008	cellulitis at injection site. Patient was given KEFLEX (250/5)									Y	10/20/2008	10/21/2008	1	None	PVT	PVT		None	None			1						1	Injection site cellulitis	FLU3~SANOFI PASTEUR~U2772AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330279	10/28/2008	DE	68.0	68		F	10/19/2008	pt had entire upper arm swelling, pain, burning, and a red ring around arm, and some dizziness/drowsiness. Used cold compress, BENADRYL, and TYLENOL per Md.				Y					Y	10/14/2008	10/15/2008	1		OTH	PUB		None	allergic to Penicillin, Strawberries			1						1	Burning sensation; Dizziness; Erythema; Oedema peripheral; Pain in extremity; Somnolence	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89981~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0551X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0330280	10/28/2008		35.0	35		M	10/15/2008	Redness in right eye, no swelling, itching. Passed after 3 days.									Y	10/08/2008	10/08/2008	0	None	MIL	MIL	None	None	None			1						1	Ocular hyperaemia	FLUN3~MEDIMMUNE VACCINES, INC.~500557P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0330281	10/28/2008	ID	16.0	16		F	10/23/2008	None other than deltoid sore per pt's mom.									Y	10/21/2008				PVT	PVT	None	None	None			1						1	Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA207AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330282	10/28/2008	NY	45.0	45		F	10/15/2008	1st time flu shot receiver slight erythema and swelling of forearms bilaterally. Pt had other ABX allergies, but not to aminoglycoside									Y	10/15/2008	10/15/2008	0		OTH	PVT	Unknown					1						1	Erythema; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88987~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330283	10/28/2008	AZ	3.0	3		M	10/23/2008	Local skin reaction 1 1/2 x 1 in red with swelling				Y					Y	10/22/2008	10/23/2008	1		PVT	UNK		None	None			1						1	Erythema; Local reaction; Swelling	FLU3~SANOFI PASTEUR~U28606AA~UNK~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330286	10/28/2008	IL	56.0	56		F	10/22/2008	Nausea, sore throat, fever/chills, legs felt numb, head like balloons Tx with SOLUCORTEF, DEPOMEDROL, ANAPROX, TAGAMOL followed by MEDROL DOSE PACK on 10/22/08				Y					Y	10/15/2008	10/16/2008	1	increased AST, ALT, Alk Phos, Amylase, CK, HGB, decreased Platelets, increased Neutrophils, decreased Lymph, urine 1+ Bilirubin Pro 1+, Urobil 3+, Bacteria 2+, Mucus 3+, Hyaline Case 2-5; ESR-nl; Influenza A&B antigens-Neg	PVT	OTH	DIAZIDE; PAXIL		allergic to DARVOCET			1						1	Alanine aminotransferase; Aspartate aminotransferase increased; Bacteria urine; Blood alkaline phosphatase; Blood amylase; Blood creatine phosphokinase; Chills; Haemoglobin; Hypoaesthesia; Influenza serology negative; Lymphocyte count decreased; Nausea; Neutrophil count increased; Oropharyngeal pain; Platelet count decreased; Protein urine present; Pyrexia; Red blood cell sedimentation rate normal; Urine bilirubin increased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA364BA~2~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0330288	10/28/2008	VA	56.0	50		F	10/23/2008	Red rash chest and back, and 10 am welt at injection site. fever 101 24 hour post injection required BENADRYL and TYLENOL									Y	10/21/2008	10/22/2008	1		PUB	UNK						1						1	Injection site rash; Pyrexia; Rash; Rash erythematous	FLU3~SANOFI PASTEUR~U2833AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330289	10/28/2008	PA	84.0	84		F	10/23/2008	No reaction during 15 min wait time at flu shot clinic. Reaction occurred 10-15 min after leaving clinic- she felt sweaty and ill allover. Client called 1 week after shot and said she had a terrible week. Weakness and generally feeling poorly x 1 week. Symptoms resolved 10/21/08									Y	10/14/2008	10/14/2008	0	None	OTH	OTH	Client doesn't know names of meds: BP meds; cholesterol; nerve meds; vitamins		HTN; High Cholesterol; Anxiety.			1						1	Asthenia; Feeling abnormal; Hyperhidrosis; Malaise	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFUA172AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0330290	10/28/2008	NH	2.0	2	.8	F	10/22/2008	An adult dose of Hepatitis A was given for the booster dose of Hep A - Should have been a pediatric dose.										10/22/2008				PVT	PVT		None				1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~UT2792DA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB251BA~2~IM~LL~HEP A (HAVRIX)~1	USA		Influenza
0330292	10/28/2008	NY	28.0	28		F	10/24/2008	Given PNEUMOVAX vaccine Lot#1175F exp  12/1/08 MERCK and FLUZONE vaccine Lot#U2768AA exp 6/30609 9.5cc of each) in left deltoid, the influenza vaccine placed in upper Deltoid and PNEUMOVAX lower. A different alcohol wipe, syringe, needle were used to prepare vaccine. Separate wipe for each area on her left Deltoid- 10/6/08 10/7/08 eve T 101 degree, left arm sore and red saw PMD 10/9-swelling 2 cm- redness, heat. Put on AVALON x 5 days improvement 10/11 and complete resolution  10/13/08				Y					Y	10/06/2008	10/17/2008	11		MIL	OTH	ALLEGRA D; PENTASA; ACIPHEX; ORTHO TRI-CYCLINE LO; Inhaler FLAVENT;		Crohn's Disease, Asthma			1						1	Body temperature increased; Erythema; Oedema peripheral; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~U2768AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1175F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0330293	10/28/2008	MI	67.0	67		M	10/24/2008	Day 1- 7hours severe hives on stomach and legs;, 12 hours, dizzy, chills, sweats for  2 hrs. Day 2- Flu symptoms 10 hrs, hives - 50%, called Dr and took TYLENOL And CLARITIN. DAY 3 and 4- Still couldn't sleep well with rash, swollen feet, went to Urgent Care, got hi-dose steroid prescription. DAY 12- severe bloody nose, gas, and diarrhea, urgent care reduced steroid pill to 1/2 d for 2 days. Day 14 - generally OK, occasional flu symptoms at night				Y					Y	10/09/2008	10/09/2008	0		PVT	PVT		None	Heart attack 4/30/08, on PLAVIX; IMETROPOLOL; ZOCOR; ASPIRIN			1						1	Chills; Diarrhoea; Dizziness; Epistaxis; Flatulence; Hyperhidrosis; Influenza; Oedema peripheral; Rash; Sleep disorder; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA154AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0330294	10/28/2008	CA	81.0	81		M	10/24/2008	Flu shot at 1400 hrs at VA on Fri 10/17/08 same day at appx. 2200 hrs had a violent reaction. Fever, cold, shakes, etc. Lasted until late Sunday 10/19/08. Arm swollen, red itching for another 3 days.									Y	10/17/2008	10/17/2008	0		UNK	UNK		None				1						1	Erythema; Feeling cold; Oedema peripheral; Pruritus; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0330296	10/28/2008	WA	10.0	10		M	10/22/2008	Flu shot was given on 10/20/08 on Pt Left arm. He developed a dime size redness the next day he has 10x12 cm red urticarial rash on his arm today										10/20/2008	10/21/2008	1	None	PVT	PUB		None	Asthma and allergies			1						1	Erythema; Urticaria	FLU3~SANOFI PASTEUR~U2806AA~5~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330297	10/28/2008	CO	45.0	45		F	10/20/2008	Pt noticed about 24 days post vaccination redness, swelling, and pain upon pressure to local are where Pneumonia shot was given									U	10/19/2008	10/20/2008	1	None	OTH	PVT		None	Penicillin allergy			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~009882~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0990U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330299	10/28/2008	CO	59.0	59		F	10/23/2008	Immunized at 11AM 10/18/08. 2PM - low grade fever-did not check temp, entire body aching-pain arm took ALEVE and heat to arm. 10/19-arm extremely painful-redness. 10/20-arm v. red, tender to touch -felt hard to touch. Continue with ALEVE. 10/21 Felt much better, fever gone, arm still tender to touch.									Y	10/18/2008	10/18/2008	0		PVT	PVT		None				1						1	Erythema; Induration; Pain; Pain in extremity; Pyrexia; Skin warm; Tenderness	FLU3~CSL LIMITED~01749111A~UNK~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~0380U~2~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330300	10/28/2008	NJ	41.0	41		M	10/26/2008	Dizziness, nausea.				Y					N	10/22/2008	10/23/2008	1		OTH	OTH	None	Dizziness	None			1						1	Dizziness; Nausea	FLUX~UNKNOWN MANUFACTURER~V2786AA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0330301	10/28/2008	MT	73.0	73		F	10/23/2008	10/16/08-Flu vaccine given. 10/17/08 Right ear red, eyes swollen, hives left side of face and neck, body itching-BENADRYL given. 10/18/08 Symptoms slowly resolving. 10/19/08 hives worsening-PREDNISONE ordered. 10/22/08 hives gone, skin red where hives were.									Y	10/16/2008	10/17/2008	1	Basic panel, CBC; sed rate; complement; T (CH-50); Myeloperoxidase ABY, proteinase 3 ABY, ANA	OTH	OTH		Rt femur fracture				1						1	Antineutrophil cytoplasmic antibody; Antinuclear antibody; Complement factor; Erythema; Eye swelling; Full blood count; Metabolic function test; Pruritus; Red blood cell sedimentation rate; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8803901~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330302	10/28/2008	ME	50.0	50		F	10/23/2008	Four hours after receiving I.M. - SOB/increased HR 120 sensation of throat tightening - hoarse - very tender throat next day - no other S/S.  O2 sat 100% (chills-aches)									Y	10/22/2008	10/22/2008	0	Sat 100%	PUB	PVT	Vitamins only	None	MSG			1						1	Chills; Dysphonia; Dyspnoea; Heart rate increased; Oxygen saturation normal; Pain; Throat tightness	FLU3~SANOFI PASTEUR~U2833AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330303	10/28/2008	TX	62.0	62		F	10/18/2008	Red rash face, arms, chest observed; Pt c/o itching, taking BENADRYL , given BENADRYL at Pt on 10/15/08. Pt went to PCP on 10/16/08  and  HYDROCYZINE and METHYLPREDNISOLONE. Dr notified on 10/15 and the other Dr notified 10/17/08				Y					Y	10/13/2008	10/13/2008	0		OTH	UNK	CLONIDINE; Furosemide; Glipizide; RENVELA		BETADINE.			1						1	Pruritus; Rash; Rash erythematous	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88981~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0330304	10/28/2008	KS	53.0	53		F	10/22/2008	Shot given Monday at approx 2:30pm itching right after adm., then later that evening had a large knot on arm that we treated with ice packs and BENADRYL. Then 2 days later (Wed.) day patient was unable to move her arm and by the end of day her fingers were swollen. Swelling went all the way thru breast. Getting better in 5 days.				Y					U	10/20/2008	10/20/2008	0		OTH	PVT	CRESTOR 5 mg daily HUMALOG;AVALIDE; FENTANYL patch; PREVACID 30 mg daily. Allergies: NSAIDS; PCN	Diabetes	Diabetes; Asthma			1						1	Immediate post-injection reaction; Induration; Injected limb mobility decreased; Oedema peripheral; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U2747AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330305	10/28/2008	AZ	30.0	30		F	10/23/2008	Received Flu shot then 20-30 minutes later got a rash on the neck, back and about 1/2 later it moved to my chest and shoulders.									U	10/23/2008	10/23/2008	0		PVT	PVT		None	Morphine; PCN.			1						1	Rash	FLU3~SANOFI PASTEUR~U2740AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330306	10/28/2008	WY	27.0	27		F	10/24/2008	Swelling, redness & pain of deltoid after IM PNEUMOVAX to (L) arm.				Y					U	10/22/2008	10/22/2008	0		PVT	UNK		H/o asthma w/ chronic cough	GERD; Asthma; Seasonal/environmental allergies; Depression			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA358AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0859U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0330307	10/28/2008	NY	8.0	8		M	10/24/2008	Diagnosed at urgent care 10-23-08 with Henoch-Schoenlein Purpura.  Seen by Dr. 10/24/08				Y						10/21/2008	10/23/2008	2	ESR 17 (no 0-15); Urinalysis, normal; CBC, normal.	PVT	PVT		None	Reactive airway			1						1	Full blood count normal; Henoch-Schonlein purpura; Red blood cell sedimentation rate increased; Urine analysis normal	FLUN3~MEDIMMUNE VACCINES, INC.~500569P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0330308	10/28/2008	CA				F	10/23/2008	Developed soreness, erythema and soft tissue swelling (mild, seems more dermal) that lasted over 4 days. It is improving.									Y	10/18/2008	10/19/2008	1	None	PUB	PUB	None	None				1						1	Erythema; Pain; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88635~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330309	10/28/2008	FL	76.0	76		F	10/23/2008	Shoulder to elbow - red, swollen hot to touch. Fever 103.				Y					Y	10/17/2008	10/17/2008	0		OTH	OTH	Ramipril; Lovaza	None	None			1						1	Erythema; Oedema peripheral; Pyrexia; Skin warm	FLU3~SANOFI PASTEUR~U2847AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0988F~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0330310	10/28/2008	IL	35.0	35		F	10/24/2008	Shortness of breath, abdominal muscle contractions. Symptoms 10-24-08 resolved after recipient took oral BENADRYL.									Y	10/23/2008	10/23/2008	0	None	OTH	PVT	None	None	Sulfa; cough syrup with Codeine.			1						1	Dyspnoea; Muscle contracture; Abdominal rigidity; Dyspnoea; Similar reaction on previous exposure to drug	FLU3~CSL LIMITED~03549111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|FLU3~CSL LIMITED~03549111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~2	USA		Influenza
0330311	10/28/2008	WI	40.0	40		M	10/24/2008	Reaction noticed within one hour of administration - scratchy throat.  Next few hours developed body aches, eyelid swelling, upper lip swelling.  N/V developed 12 hours after vaccination.  Reported to this provider 15 hours post vaccination.  Contacted his personal MD - refused emergency department treatment.  Encouraged 50mg Benadryl P.O. and 650mg acetaminophen P.O.									U	10/23/2008	10/23/2008	0	None at this time	OTH	OTH	None	Cold/G.I. illness 1 week ago - no fever	None - does not eat eggs - vegan			1						1	Eyelid oedema; Lip swelling; Nausea; Pain; Throat irritation; Vomiting	FLU3~SANOFI PASTEUR~U2743AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330312	10/28/2008	ME	56.0	56		F	10/24/2008	Developed cough about 5 hours after the vaccine - became dry, hacking cough that lasted several hours, some joint achiness.									Y	10/23/2008	10/23/2008	0	None	PVT	PVT	Trazodone; Estradiol; Clonipine; Vits	None	No quinolones - hives, Amox - itch			1						1	Arthralgia; Cough	FLU3~SANOFI PASTEUR~U2833AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330313	10/28/2008	WA	40.0	40		F	10/22/2008	Influenza vaccine administered. Recipient reported 8 days later that immediately after receiving vaccine she felt tired and exhausted. By 8PM she vomited every 30 minutes. Fever of 103 degrees F by 7pm. Body pain, particularly in spine. Throat was tight for several days afterwards. Also short of breath days after.									Y	10/13/2008	10/13/2008	0	None	OTH	PVT	None					1						1	Dyspnoea; Fatigue; Immediate post-injection reaction; Pain; Pyrexia; Throat tightness; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA185AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330314	10/28/2008	OH	67.0	67		F	10/22/2008	Pt reported lightheadedness, flushing face 435 PM. Given ammonia pearl 455 PM, reported urticaria. Given .5 ml Epi (L) deltoid SQ. Squad called and transported to hospital 515 PM.				Y					U	10/22/2008	10/22/2008	0		PUB	UNK		None		Septic shock~Hep B (no brand name)~UN~61.00~In Patient		1						1	Dizziness; Flushing; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881173P~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0330315	10/28/2008	AZ	68.0	68		F	10/24/2008	Notice pain in arm progressed to tingling going down arm to hand. Unable to make a fist. Has episodes at nite with intense pain. Hurt is relieved when she gets up and moves about happened 3x last nite. 10/28/08 went to doctor, he doesn't know what it is. Take ALEVE and call him on Monday									U	10/14/2008	10/14/2008	0		PUB	PVT	On thyroid meds and vitamins	None	On Thyroid meds			1						1	Grip strength decreased; Pain in extremity; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA158AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330317	10/28/2008	CT	1.0	1	.0	M	10/24/2008	Three lesions on neck, head, side.									Y	10/06/2008	10/15/2008	9	None	PVT	UNK		None	None			1						1	Skin lesion	FLU3~SANOFI PASTEUR~UT2782DA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C86139~4~UN~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0791X~1~UN~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0330318	10/28/2008	UT	55.0	55		F	10/24/2008	Whole body ached, fever, sweating. Headache, difficulty walking due to muscle pain. Patient feels hot inside but not to touch. Local reaction - 2 days later - site of injection is red, inflamed, hot to touch. (T-97.4 BP-104/71 WBC 13.2).				Y					U	10/21/2008	10/22/2008	1		OTH	PVT	Strattera; Adderall;, Singulair; DIOVAN	None	Asthma			1						1	Body temperature; Feeling hot; Gait disturbance; Headache; Hyperhidrosis; Injection site erythema; Injection site inflammation; Injection site warmth; Local reaction; Myalgia; Pain; Pyrexia; White blood cell count increased	FLU3~SANOFI PASTEUR~U2772AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0990U~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0330320	10/28/2008	OH	22.0	22		F	10/22/2008	Headache, muscular aches, back aches, common cold like symptoms.									Y	10/14/2008	10/14/2008	0		PUB	PVT			Pcn, Sulfa based			1						1	Back pain; Headache; Myalgia; Nasopharyngitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88635~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330321	10/28/2008	IL	31.0	31		F	10/22/2008	3 hours post vaccination, felt very sick to stomach.  After finishing shift and returning home.  I ate a little dinner.  About an hour after that vomited.  I had stomach cramping thru the night.  By morning, I was feeling better.  4 days after shot, arm still sore and noticed golf ball sized lymph node on left clavicle, which is the side where the vaccine was given.  I saw my family doctor who said he thought it was from the shots - monitor side of lymph node.  Lymph node is slowly returning to normal size.				Y					Y	10/07/2008	10/07/2008	0		PUB	UNK		None	Respiratory allergies			1						1	Abdominal pain upper; Lymphadenopathy; Pain in extremity; Stomach discomfort; Vomiting	FLU3~SANOFI PASTEUR~U2759AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330324	10/28/2008	MI	28.0	28		F	10/23/2008	Shortly after getting flu shot (R) arm became red and blotchy - spread to chest neck and face around 4 PM. After lunch came to RPh and he gave her 25 mg Diphenhydramine. Rash subsided 45 min after diphenhydramine given.									Y	10/22/2008	10/22/2008	0	None	PUB	PVT	Loratadine; Metformin; Phentermine	No	Seasonal allergies; Asthma			1						1	Erythema; Rash macular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA171AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330325	10/28/2008	MN	60.0	60		M	10/22/2008	At end of workday, pt felt cold. He went home - got colder. By 745 PM, he was very chilled. He took his BP - 190/100 and decided to go to ER. At ER, temp was 101 w/ BP elevated. Was given TYLENOL. Lab work/chest x-ray done. BP came down as did temp. Discharged from ER.				Y					Y	10/21/2008	10/21/2008	0	Chest X-ray; Blood/urine check - ? looking for infection	PUB	PVT	Multivit; ASA; Zetia; Lisinopril; Lipitor; Metoprolol	None	Penicillin allergy; Cardiac hx - bypass 2003; Hiatal hernia surgery 2001			1						1	Blood pressure increased; Blood test; Body temperature increased; Chest X-ray; Chills; Feeling cold; Urine analysis	FLU3~SANOFI PASTEUR~U2768AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330327	10/28/2008	NY	4.0	4		M	10/22/2008	Injection site left arm - large red raised lump itchy (DTaP) warm compress, Motrin, Benadryl given.									Y	10/20/2008	10/21/2008	1	Child temp was 100.8 when vaccine given.	PVT	PVT	None					1						1	Injection site erythema; Injection site mass; Injection site pruritus; Injection site swelling	DTAP~SANOFI PASTEUR~C2999AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2772AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330328	10/28/2008	WA	76.0	76		M	10/28/2008	On 10/15 received flu vax. About 6 hours later felt discomfort in area of the shot. Next day had the worst pain in elbow. Few days later received Pneumo vax - shot was given in the arm became very sore red and tender. Lasted 2 days.				Y					Y	10/15/2008	10/15/2008	0		PVT	UNK		No	High blood pressure - Cholesterol			1						1	Arthralgia; Discomfort; Erythema; Pain; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0330329	10/28/2008		34.0	34		F	10/21/2008	Received Flu shot 10-20-08 Lot #01849111A Manufacturer CSL Biological on 10-20-08 c/o (R) Deltoid swollen, bruise and redness.										10/20/2008	10/20/2008	0	None	UNK	UNK			None			1						1	Contusion; Erythema; Oedema peripheral	FLU3~CSL LIMITED~01849111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0330330	10/28/2008	IA	67.0	67		M	10/20/2008	Patient reported red spots, that contained a clear fluid on hands, chest & back, that itch. No fever. No difficulty breathing, no swollen tongue/throat. Patient taking Benadryl and topical 1% Hydrocortisone Cr. Went to family MP. Triamcinolone 0.5% Cr. Ordered 10/25/08.				Y					U	10/15/2008	10/17/2008	2		OTH	PVT	Cialis; Omaperazole; Zolpidem; Avalide; Nystatin; Triamcinolone Cr	Unknown	No known Allergies			1						1	Rash erythematous; Rash pruritic; Rash vesicular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0330331	10/28/2008	NY	46.0	46		F	10/28/2008	Throat felt swollen, called doctor who noted voice to be hoarse. Pt was directed to seek care at the ED. Given IM Benadryl and PO steroids.				Y					Y	10/27/2008	10/27/2008	0	None	PVT	PVT	Synthroid; Niaspan; Allegra; Flonase; Toprol XL	None	Hypothyroidism; Hyperlipidemia; HTN; IBS			1						1	Dysphonia; Pharyngeal oedema; Dysphagia; Dysphonia; Pharyngeal oedema; Throat tightness	FLU3~SANOFI PASTEUR~U2748AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2748AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0330331	10/28/2008	NY	46.0	46		F	10/28/2008	Approximately 2 and 1/2 hours after receiving the flu vaccine the patient called the office exchange. She spoke with Dr. c/o her throat feeling tight and swollen with difficulty swallowing. Dr. noted her voice to be hoarse and sent her to the closet emergency department. A follow-up telephone revealed that the patient was given IM Benadryl in the ED and was sent home on a tapering steroid dose regimen. Symptoms completely resolved the morning following vaccination.				Y					Y	10/27/2008	10/28/2008	1	None	UNK	UNK	Niaspan, Synthroid, Allegra, Flonase, Toprol XL	None	Hypothyroidism, Hyperlipidemia, Hypertension, IBS, GERD, Allergic Rhinitis, Chronic Sinusitis			1						2	Dysphonia; Pharyngeal oedema; Dysphagia; Dysphonia; Pharyngeal oedema; Throat tightness	FLU3~SANOFI PASTEUR~U2748AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2748AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0330332	10/28/2008	OH	29.0	29		F	10/22/2008	Sore and weak in (R) arm where flu injection was administered. Chest pain.				Y					Y	10/21/2008	10/22/2008	1	Steroid shot and EKG	PUB	UNK						1						1	Chest pain; Electrocardiogram; Injection site pain; Muscular weakness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA359CA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0330333	10/28/2008	OH	55.0	55		F	10/22/2008	After administration of vaccine - itching, red, swollen and warm - next day still red and swollen itching stopped.									Y	10/21/2008	10/21/2008	0		MIL	OTH		None	None Known			1						1	Erythema; Pruritus; Skin warm; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA359CA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330334	10/28/2008	OH	65.0	65		F	10/22/2008	Redness, warmth, soreness only at injection site 6 cm diameter.									Y	10/20/2008	10/21/2008	1	None	MIL	OTH		No	Hepivocaine; Tetanus, BP Med			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA359CA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330335	10/28/2008	FL	62.0	62		F		Received vaccine at 3:15pm on 10-1-08. By 5:30 I began coughing non stop, wheezing and short of breath. Went to ER where I was given oxygen, Prednisone drip and a Nebulizer X 2. Now is 10-21-08 and iam still sick and under medical care.				Y					N	10/01/2008	10/01/2008	0		OTH	PUB		None	None			1						1	Cough; Dyspnoea; Oxygen supplementation; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0330344	10/28/2008	CO	5.0	5		F	10/24/2008	Rash around  DTaP / IPV site - size of a quarter, pimple - like bumps - red area - rash started next day- lasted for 5 days- without fever.									Y	10/10/2008	10/11/2008	1		PVT	PVT	None	None	None			1						1	Injection site erythema; Injection site rash	DTAP~GLAXOSMITHKLINE BIOLOGICALS~C2953AA~5~UN~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2749AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB294BA~2~UN~LA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~A0491~4~UN~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1011X~2~UN~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1016X~2~UN~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0330362	10/28/2008	MA	54.0	54		F	10/22/2008	Vaccine recipient complained of slightly swollen and numb tongue, 5 hours after receiving influenza vaccine.									Y	10/21/2008	10/21/2008	0	None	OTH	PVT	Cholesterol and blood pressure med's unknown	None	Bee sting allergy - anaphylaxis / HTN			1						1	Hypoaesthesia oral; Swollen tongue	FLU3~SANOFI PASTEUR~U2745AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330367	10/28/2008	SC	27.0	27		F	10/28/2008	Extreme itchiness (onset day after vaccination). Extreme swelling of all joints (onset 30 hours after vaccination). Went to Clinic on 10/25/2008 and was prescribed Tapered Oral Steroid Therapy, Dexpac Jr. 10 Day.  Was able to fill prescription midday 10/26/2008. Very little mobility on 10/26 due to swelling and joint pain.				Y					Y	10/23/2008	10/24/2008	1		UNK	UNK	Birth Control (Microgestin FE)	None	None			1						1	Arthralgia; Joint swelling; Mobility decreased; Pruritus	FLU3~SANOFI PASTEUR~Not Given~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330370	10/28/2008	NY	72.0	72		F	10/28/2008	Swelling of tongue									Y	10/11/2008	10/11/2008	0		PUB	PUB		none	penicillin - swelling of tongue			1						1	Swollen tongue	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88635~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330373	10/28/2008	FL	38.0	38		M	10/28/2008	Clear productive cough, bronchospasms, sore throat one week after (Fluarix vaccine Lot:AFLUA358BA). SYMTOMES STILL PERSIST UP TO TODAY. NO RELIF AFTER 4 DAYS OF LEVAQUIN ABX									N	10/06/2008	10/15/2008	9	NONE	PVT	UNK						1						1	Bronchospasm; Oropharyngeal pain; Productive cough	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA358BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330374	10/28/2008	AR	55.0	55		F	10/28/2008	I received the fluzone vaccine on 10/22/2008, (lot # U2757AA,Sanofi Pasteur) IM in my right deltoid.  Throughout the day there was minimal pain in my right arm but no swelling or redness at the injection site.  Approximately 14-15 hours after receiving the vaccine I awoke from sleep with severe pain in both arms, but much worse in the right.  I experienced burning pain throughout both arms, deep in the muscles and in my joints.  The pain was in my wrists, elbows, hands and deep in my right armpit and into my right breast. I took ibuprofen 600 mg every 4-6 hours x 24 hours with little relief.  The left arm pain resolved within 24 hours but the right arm pain continued, and gradually subsided after 48 - 72 hours.									Y	10/22/2008	10/23/2008	1		PVT	UNK						1						1	Arthralgia; Axillary pain; Breast pain; Burning sensation; Myalgia; Pain in extremity	FLU3~SANOFI PASTEUR~U2757AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330379	10/28/2008	TX	27.0	27		M	10/28/2008	Patient was given flu shot at approx. 1405pm on 10/27/08. 15 to 20 minutes later, he complained of itching and hives to his back. He took a Benadryl shortly after noticing the hives which stopped the itching. Hives persisted, and at  15:57, he sought treatment in the Emergency Room at Hospital.				Y					Y	10/27/2008	10/27/2008	0		UNK	UNK	NONE	DENIES	ALLERGIC TO PENICILLIN			1						1	Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA358AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0330381	10/28/2008	CA	1.58	1	.6	F	10/28/2008	C/O FEVER @103.5 X1 NIGHT/VOMITING X6 TIMES x1 DAY AFTER VACCINES GIVEN ON 10/27/2008. CONTINUE GIVEN MOTRIN FOR FEVER IF NEEDED BRAT DIET IF NOT BETTER TRTURN TO CLINIC.									N	10/27/2008	10/28/2008	1		PUB	UNK	MOTRIN	NONE	NONE			1						1	Pyrexia; Vomiting	DTAP~SANOFI PASTEUR~U2397AA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT2785CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330382	10/28/2008	ME	4.0	4		M	10/28/2008	L arm- raised red mark around injection site. Warm to the touch. Area was itchy for pt. Seen by Dr. in office on 10/24/08. Benedryl 12mg every 6hrs as needed.									Y	10/22/2008	10/23/2008	1		PVT	PUB		none	none			1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Injection site warmth	DTAP~SANOFI PASTEUR~C2957AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2797DA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A1060~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0503X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0330388	10/28/2008	IA	46.0	46		F	10/28/2008	Rec'd vaccine 10/21/08. Patient reports that on 10/22/08 there were red welts on her arms, legs, and hands which itched. No redness or reaction at the site of the injection. Her personal physician related the symptoms to the vaccine administration but did not prescribe any type of treatment. Patient did not report reaction to us(her employer)until today 10/28/08.									Y	10/21/2008	10/22/2008	1	None	UNK	UNK	Unknown	None	Unknown			1						1	Rash erythematous; Rash pruritic; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA184AA~UNK~IM~~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0330389	10/28/2008	MI	25.0	25		F	10/28/2008	GIVEN STAFF FLU VACCINE AT 1:30PM ON 10-27-08.  10 MINUTES AFTER RECEIVING FLU VACCINE, SHE APPEARRED FLUSHED ON NECK/CHEST. COMPLAINTS OF FEELING FUNNY, HEART RACING, FEEL LIKE I AM BURNING UP.  BROUGHT HER TO DR.  VITAL SIGNS ELEVATED, BLOOD PRESSURE 162/82, PULSE 140, RESPIRATIONS 28. RECHECKED EVERY TEN MINUTES AS SYMPTOMS WERE LESSENING.  TOOK 30 MINUTES BEFORE BLOOD PRESSURE AND VITAL SIGNS BACK IN NORMAL RANGE.  SYMPTOM OF FEELING HOT CONTINUED.  SHE PHONED HER PRIMARY CARE DR, WHO ADVISED HER TO TAKE BENADRYL.  SYMPTOMS IMPROVED WITHIN 20 MINUTES AFTER TAKING BENADRYL.  TODAY SHE STILL FEELS WARM, BUT MOSTLY BETTER.				Y					Y	10/27/2008	10/27/2008	0	NONE	UNK	UNK	NONE	NONE	NONE			1						1	Blood pressure increased; Feeling abnormal; Feeling hot; Flushing; Heart rate increased; Palpitations; Respiratory rate increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0330391	10/28/2008	OH				F	10/28/2008	Employee received Flu Vaccine and reports to me that 1 hour later c/o throat tightness, severe Rt arm pain and dysphagia. Took a Benadryl 50mg and in 20 minutes tells me her symptoms were gone. She did not seek Medical Intervention.									Y					UNK	UNK			Reaction to TB test years ago per employee			1						1	Dysphagia; Pain in extremity; Throat tightness	FLU3~SANOFI PASTEUR~U2802AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330392	10/28/2008	AL	65.0	65		F	10/28/2008	Severe pain, swelling and redness of right arm.  Muscle weakness (difficult to raise arm even for light duty activities for ~36 hours). Nausea and vomiting developed 22-24 hours later.  Fully recovered by day four.									Y	10/09/2008	10/09/2008	0		UNK	PVT	Premarin,Detrol,Tricor,Pravachol,acyclovir,Prilosec	none	none			1						1	Erythema; Injected limb mobility decreased; Muscular weakness; Nausea; Oedema peripheral; Pain in extremity; Vomiting	FLU3~SANOFI PASTEUR~U2772AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1035F~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330394	10/28/2008	TX	7.0	7		M	10/28/2008	Patient has Pervasive Developmental Disorder.  He was given Flu Mist on 10/20/08 and proceeded to have 3 days of listless behaviour and confusion.  He was improved by the third day.									Y	10/20/2008	10/21/2008	1		PVT	PVT	Benadryl prn non given during this time	None	PDD			1						1	Confusional state; Listless	FLUN3~MEDIMMUNE VACCINES, INC.~500563P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0330397	10/28/2008	NJ	55.0	55		F	10/28/2008	Patient noted problem swishing mouth while brushing teeth the morning after vaccination. Diagnosed by her physician with Bell's palsy.  11/14/08 Reviewed PCP medical records of 10/27-10/31/2008. FINAL DX: Bell's palsy left, visual disturbance, conjunctivitis left eye. Records reveal patient experienced red eye tearing, burning, blurry vision, unable to close completely & had accidentally touched eye.  Tx w/antiviral & steroids.  Referred to opthalmo & neuro.  Ophthalmo exam abnormal w/no blink reflex & incomplete lid closure left eye.  Dx w/punctate deratitis OS, tx w/meds.  Neuro exam abnormal & concurred w/dx & tx.				Y					U	10/22/2008	10/23/2008	1	Family doctor did blood work, patient states it was normal except for elevated cholesterol.	UNK	UNK	No prescription medications	No	None			1						1	Blood cholesterol increased; Blood test normal; Facial palsy	FLU3~SANOFI PASTEUR~U27856A~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330399	10/28/2008	CT	42.0	42		M	10/28/2008	received vaccine at 3pm /Developed swelling of mouth, eyes and difficulty breathing at 4:30pm.Did not seek medical attention until next morning at which time he went to ER. Given IV prednisone and sent home with script for oral prednisone.				Y					Y	10/27/2008	10/27/2008	0		PUB	PUB						1						1	Dyspnoea; Eye swelling; Oedema mouth	FLU3~SANOFI PASTEUR~u2748AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330400	10/28/2008	PA	55.0	55		F	10/28/2008	Patient stated she had a fever, bad rash, and pain from her shoulder to her elbow.  Her fever is now gone but she continues to have some pain and a rash.  She contacted her dr and was put an zithromax and prednisone.				Y					Y	10/25/2008	10/25/2008	0	N/A	PUB	PUB	UNKNOWN	NO	NO			1						1	Pain in extremity; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U2806AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1161X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0330402	10/28/2008	OH	39.0	39		F	10/28/2008	Employee seen 4 days after vaccination, 2 inch wide around upper arm, swollen and warm to touch. Site slightly reddened and warm to touch. No itching reported. Employee unaware of any allergies to food or drugs.									Y	10/16/2008	10/16/2008	0	none	PVT	UNK		none	on anti seizure medication			1						1	Injection site erythema; Injection site warmth; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U2786CA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330403	10/28/2008	KY	44.0	44		F	10/28/2008	Approximately two hours after receiving the vaccine, I was flush, lightheaded and dizzy.  The next morning I awoke with a large hematoma two inches from the injection site, which extended to my armpit. I have continued to have constant sinus drainage, hoarseness, cough, sore throat, swelling of the throat and face, conjestion fatigue, extreme tenderness at the site of the hematoma (approx. 3inches by 2inches) and a low grade fever of 101.2.  The vaccine was administered at 3:00pm on Wednesday, October 22nd and I am still having tenderness on the arm, lightheadedness, mild facial swelling and conjestion, drainage and cough.  I have been to the employee health unit at the hospital and they have noted the hematoma on the arm.									N	10/22/2008	10/22/2008	0	I am scheduled to see an allergist on Monday, November 1st.	PUB	UNK		none	food allergies, including sensitivity to eggs			1						1	Cough; Dizziness; Dysphonia; Fatigue; Flushing; Injection site haematoma; Injection site pain; Oropharyngeal pain; Pharyngeal oedema; Pyrexia; Rhinorrhoea; Swelling face; Upper respiratory tract congestion	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330405	10/28/2008	NC	3.0	3		M	10/28/2008	Within 5 minutes of receiving the shot, he got very pale, and very dizzy, and collapsed. His heart rate dropped, I kept yelling to him to keep him alert and not to pass out. His eyes kept rolling, this was horrific to see my son like this. This eppisode lasted 15 minutes!!!!!We were at the doctors when this occured. After 1/2 he was able to sit up, though he was very weak. Please let us know if there were others that had this problem witht his batch?				Y					Y	10/15/2008	10/16/2008	1		PVT	UNK		none	nuts			1						1	Asthenia; Dizziness; Gaze palsy; Heart rate decreased; Pallor; Syncope	FLU3~SANOFI PASTEUR~u2786ba~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330406	10/28/2008	WI	62.0	62		F	10/28/2008	Rash on arms (multiple wheals, erythema on the extensor surface of the upper arms, few scattered wheals on the back and chest. Cheeks flushed, slight erythematous									Y	10/15/2008	10/16/2008	1		UNK	UNK	Celebrex, Acachol					1						1	Erythema; Flushing; Rash; Urticaria	FLU3~SANOFI PASTEUR~U2808AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330407	10/28/2008	IL	49.0	49		F	10/28/2008	About 12 hours after the vaccine had a violent vertigo attack with vomiting which lasted for about 6 hours.  This is the second time this has happened to me in the past 3 years after receiving a flu vaccine.									Y	10/27/2008	10/28/2008	1	None	PUB	UNK	Dyazide and Verapimil	None	Central Nervous System Vertigo  and Tachycardia	vertigo and vomiting~Influenza (Seasonal) (no brand name)~1~46.00~In Patient		1						1	Condition aggravated; Vaccine positive rechallenge; Vertigo; Vomiting	FLUX~UNKNOWN MANUFACTURER~unknown~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330408	10/28/2008	WI	43.0	43		F	10/28/2008	Cough, full body aches, stabbing pain all over her body, frontal and occipital headache, loss of appetite.Persisted for 36 hours									Y	10/20/2008	10/20/2008	0		UNK	UNK						1						1	Anorexia; Cough; Headache; Pain	FLU3~SANOFI PASTEUR~U2767AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330409	10/28/2008	TX	59.0	59		M	10/28/2008	3 days after vaccine, had onset of urticaria on trunk.  Next day, tender urticaria on feet, malaise, mild fever.  Next day onset of severe sore throat, feeling of congestion and Urticaria multiforme over trunk, extremities, even some on head. 8 days subsequent to receiving vaccine, still has urticaria multiforme, severe sore throat, temp of 99.3 and marked malaise.  Treated today with Epinephrine 1:1000 0.5cc SubQ, Decadron 1cc/Kenalog-50 1cc IM, Atarax 25mg, 2 tabs Q6H PRN and oral analgesics.				Y					U	10/20/2008	10/23/2008	3	Strep Test:  Negative	UNK	UNK	NONE	NONE	NONE			1						1	Malaise; Oropharyngeal pain; Pyrexia; Rash; Respiratory tract congestion; Streptococcal identification test negative; Tenderness; Urticaria	FLUX~UNKNOWN MANUFACTURER~unknown~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0330411	10/28/2008	NH	25.0	25		F	10/28/2008	muscle pain at inj. site and sl. weakness to arm for 2 weeks post injection									U	10/14/2008	10/14/2008	0	N/A yet	PVT	PUB	none	none known	none	None~ ()~NULL~~In Patient		1						1	Injection site pain; Muscular weakness; Myalgia	FLU3~SANOFI PASTEUR~U2762AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330414	10/28/2008	NY	38.0	38		F	10/28/2008	On 10/16/08 at approximately 10:30 a.m. I started to feel light headed and dizzy. I went home at 11:30 a.m. and by the time I got home I felt dizzy, light headed, I had the chills and felt weak. I had to lay down and did not start to feel better until the next morning. I have never had a reaction to the vaccination before.									Y	10/15/2008	10/16/2008	1	n/a	UNK	UNK	N/A	SLIGHT COLD	N/A	N/A~ ()~~0.00~Patient		1						1	Asthenia; Chills; Dizziness; No reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~U2847AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330416	10/28/2008	NV	12.0	12		F	10/28/2008	Elevated temperature and flushing of face within 15 minutes.  All over body and face rash within 24 hours of influenza vaccine.  Rash ongoing after 72 hours.  Person injecting the vaccine had trouble with the syringe and estimates that only 50% of injection was administered.									N	10/25/2008	10/26/2008	1		PUB	UNK		None	Sulfa allergy; suspected allergy to chlorhexidine from surgery for chronic non bacterial osteomyelitis OR bacterial osteomyelitis (not yet determined)			1						1	Body temperature increased; Flushing; Medical device complication; Rash generalised; Underdose	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330417	10/28/2008	NY	38.0	38		M	10/24/2008	Fever 103 degrees F  continued illness for three days.									U	10/21/2008	10/21/2008	0	Stool Ova & Parasites; Giardia, stool culture	PUB	PUB		None noted	Sufonyl; Loop/TZ/CAI			1						1	Culture stool; Malaise; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88906~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330418	10/28/2008	NY	58.0	58		F	10/28/2008	Four days after the shot I started coughing and spitting up cold.  Friday I continue coughing, spitting, and had a fever.  Saturday coughing  continue and a running nose.  Sunday coughing and running nose continues. Monday running nose and head cold symptoms.  Tuesday is the first day I felt better even though I felt completly dry.									Y	10/19/2008	10/23/2008	4		UNK	PUB	None	none	asthma,			1						1	Cough; Nasopharyngitis; Productive cough; Pyrexia; Rhinorrhoea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA356AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330419	10/28/2008	CT	53.0	53		M	10/28/2008	7 hours later:  chills.  8 hours later:  Fever between 102 and 103.  Next day:  Low grade fever, fatigue.  Continued difficulty with heat regulation (sweating) the following day.									Y	10/25/2008	10/25/2008	0	none	PUB	UNK		none		none~ ()~NULL~~In Patient		1						1	Chills; Fatigue; Hyperhidrosis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330420	10/28/2008	ME	63.0	63		F	10/28/2008	I have a flu shot through the system of flu clinics.  I had a very severe reaction including fever, vomiting, yellow discharge from the eyes, spasmodic coughing and coughing up white blobs of mucous.  Shot was administered approximately 9:15 a.m. on 10/27/08.  The effects started about 2 hours after shot was administered and ended enough to allow sleep at 2 a.m. on 10/28/08.  Today, 10/28/08, I felt well enough to drive and eat and do some grocery shopping.  I am concerned about long-term effect of this awful experience.  I was not treated for this but just stayed in bed until the problem subsided.										10/27/2008	10/27/2008	0	none	UNK	UNK		none	mold allergy, latex allergy			1						1	Activities of daily living impaired; Cough; Eye discharge; Productive cough; Pyrexia; Sleep disorder; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330421	10/28/2008	IN	73.0	73		M	10/28/2008	Experienced swelling of the lips and face with numbness in the lips.  Visited my Doctor and received a steroid pack for treatment.  This occurred the morning of the third day after receiving the shot.  I am almost back to normal today									Y	10/24/2008	10/27/2008	3	None	PUB	PUB	Actonel,  Atacand + Hct. Simvistatin, Flomax, Diltiazem	none	none			1						1	Hypoaesthesia oral; Lip swelling; Swelling face	FLUX~UNKNOWN MANUFACTURER~unknown~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330432	10/28/2008	CA	17.0	17		M	10/27/2008	Cardiac arrest! Stopped breathing, collapsed! CPR w/in 5 mins, AED w/in 10 mins Paramedics. ER - implanted w/ ICD. 11/12/08-records received for ED visit 10/21/08-presented after a witnessed collapse while in basketball practice. AED was connected and a single shock given. At ED awake confused and agitated. Transferred to another facility.12/1108-records received for DOS DC 10/21-10/26/08-DX ventricular fibrillation status post implantation of cardiac defibrillator.			Y		Y	5			Y	10/17/2008	10/21/2008	4	Everything Was Normal!  11/12/08-records received-CO2 decreased 19, BUN increased 23, anion gap increased 23, creatinine increased 1.48, CK increased 378. CT head normal brain. Chest x-ray normal. CSF normal.  12/11/08-records received-LP negative-chest x-raynormal. Initial EKG prolonged QT segment the normal.	PVT	UNK		None	Seasonal coughing/allergies 1 per yr. 11/12/08-records received-PMH: tear, anterior cruciate ligament (ACL).			1						1	Cardiac arrest; Implantable defibrillator insertion; Respiratory arrest; Syncope; Cardiac arrest; Cardiac electrophysiologic study normal; Catheterisation cardiac normal; Chest X-ray normal; Echocardiogram normal; Electrocardiogram normal; Implantable defibrillator insertion; Ventricular tachycardia	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U2637AA~2~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500540PV~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|MNQ~SANOFI PASTEUR~U2637AA~1~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2	USA	Life Threatening,Hospitalisation	Influenza
0330435	10/28/2008	CO	30.0	30		F	10/21/2008	8 days after INFLUENZA vaccine @ deltoid, developed (R) hand numbness, tingling, (R) shoulder pain, (R) ear pain, (R) eye pain, MRI normal Head, (R) eye corneal abrasion, funduscopic exam normal, Prescribed PREDNISONE 100mg taper ACYCLOVIR - pt is pregnant and responding to meds - likely early Bell's palsy.				Y					Y	10/07/2008	10/15/2008	8	Head MRI normal, ophtho exam funduscopic normal	UNK	UNK		Mild allergies	PCN, abnormal pap smear			1						1	Corneal abrasion; Drug exposure during pregnancy; Ear pain; Eye pain; Facial palsy; Fundoscopy normal; Hypoaesthesia; Musculoskeletal pain; Nuclear magnetic resonance imaging normal; Ophthalmological examination; Paraesthesia	FLU3~SANOFI PASTEUR~2747AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330438	10/28/2008	CA	8.0	8		F	10/28/2008	Child had wheezing									U	10/17/2008	10/20/2008	3		PVT	PUB						1						1	Wheezing	FLU3~SANOFI PASTEUR~U2808AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330439	10/28/2008	TX	14.0	14		F	10/28/2008	Pt came for well visit on 10/13/08. At that time reported to me that when pt got her Gardasil #1 on 9-22-07 about 1 week later pt began to fall her legs were weak, she had decreased sensation. She also had experienced numbness and tingling. She has seen ortho and neuro. MRI of spin and brain normal. Better  now some improvement, occas has symptoms 11/20/08-records received-office visit 10/10/07-At age 7 diagnosed with OCD is stable-repeats selft serveral times when worried. Rarely smiles or laughs. DC: Obsessive-Compulsive Disorder. Office visit 1/29/08-increasing ruminating thoughts and checking rituals have improved still some OCD thoughts. Anxious at times. Office visit 6/3/08-Doing well. 11/17/08-continues to do well overall.									N	09/22/2007	09/29/2007	7	MRI of brain and spine normal per her  neurologist	PVT	PVT	Prozac, seoquel	None	OCD, scoliosis			1						1	Asthenia; Hypoaesthesia; Nuclear magnetic resonance imaging brain normal; Nuclear magnetic resonance imaging normal; Paraesthesia	FLU3~SANOFI PASTEUR~U2455AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1061U~1~IM~RA~HPV (GARDASIL)~1	USA		Influenza
0330440	10/28/2008	PA	54.0	54		F	10/27/2008	Pain at injection site almost immediately. Gradually developed (L) arm heaviness and numbness 2 days after injection. No hives/swelling.									N	10/21/2008	10/23/2008	2	None	PVT	OTH	None	No	Sulfa	No~ ()~~0.00~In Patient		1						1	Hypoaesthesia; Immediate post-injection reaction; Injection site pain; Sensation of heaviness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA367EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330441	10/28/2008	PA	37.0	37		F	10/27/2008	Sore at injection site for two day. On 10/25/08 had increased (L) arm pain, numbness of (L) arm and hand heaviness of (L) arm. Unable to raise arm (L) over head.									N	10/21/2008	10/25/2008	4	No	PVT	OTH	CELEBREX 100 mg t b, NORFLEX 100 mg T bid prn, ATIVAN 0.5mg prn, MULTI VIT t AM, Ultram 50 mg, t bid	No	S/P thoracic syndrome	No~ ()~~0.00~In Patient		1						1	Hypoaesthesia; Injected limb mobility decreased; Injection site pain; Pain in extremity; Sensation of heaviness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA367EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330442	10/28/2008	WI	48.0	48		M	10/27/2008	Swelling, red, tender left upper arm with pain, fever, seen in ER on 10.12.8 & Dx: Cellulitis Tx: KEFLEX 500 BID X 10 days. With unremarkable recovery				Y					Y	10/10/2008	10/11/2008	1	WBC: 13.5; 6RAN: 10.8; BMP & Remainder of CBC Normal	PVT	PVT	PROTONIX	Bronchitis/Cough	NKDA	None~ ()~~0.00~In Patient		1						1	Cellulitis; Erythema; Full blood count normal; Granulocyte count increased; Metabolic function test normal; Oedema peripheral; Pain in extremity; Pyrexia; Tenderness; White blood cell count increased	FLU3~SANOFI PASTEUR~U2784AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0612X~1~UN~LA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~UF455AA~1~UN~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0330446	10/28/2008	GA		0	.0	F	10/27/2008	I received the Flu-shot morning of Oct-17. I woke up Oct. 18 and the left side of my face was experiencing paralysis. I could not use the left side. My lips were swollen, along with my cheek and left eye.				Y					N	10/17/1980	10/18/1980	1	Bells Palsy	PUB	OTH		None	None			1						1	Eye swelling; Facial palsy; Lip swelling	FLU3~SANOFI PASTEUR~U2770AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330447	10/28/2008	MI	2.0	2	.5	M	10/28/2008	None - monitor for symptoms of fever, malaise; injection site for redness, swelling, and N/V over the next week.									Y	10/28/2008			None	PVT	OTH	None	None	VSD			1						1	Inappropriate schedule of drug administration; No adverse event	FLU3~SANOFI PASTEUR~U2739AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330450	10/28/2008	WA	73.0	73		F	10/27/2008	Fever, swelling at site of injection, redness pain and nausea.				Y					N	10/18/2008	10/19/2008	1		OTH	OTH						1						1	Injection site erythema; Injection site pain; Injection site swelling; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0962U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0330451	10/28/2008	NH	43.0	43		M	10/28/2008	Had flu vax in (L) arm. 48-72 hours later developed stiffness + discomfort (L) upper trapezius which has persisted. Is better in AM - gets worse during day. Topical muscle rub helps. Wife with similar discomfort.									N	10/14/2008	10/16/2008	2	None	PVT	PVT	LOTREL 10/20; ALLEGRA 150MG; HCT2 35MG; SINGULAIR 10MG; NEXIUM 40MG; NASONEX NASAL	No	HTN, allergic rhinitis, asthma, anxiety  chronic sinusitis	None~ ()~~0.00~In Patient		1						1	Discomfort; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U2811AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330454	10/28/2008	CA	48.0	48		F	10/22/2008	Patient given INFLUENZA vaccine on 10/15. Patient reported on 10/16 she developed swelling, erythema tenderness, and site was warm to the touch. Patient sent to clinic for eval, was referred to workers comp. Dx'ed allergic reaction to vaccine.				Y					Y	10/15/2008	10/15/2008	0		PUB	PUB		None	Sulfa	2007~Influenza (Seasonal) (no brand name)~1~47.00~In Patient		1						1	Hypersensitivity; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88635~2~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0330458	10/28/2008	GA	60.0	60		F	10/28/2008	I returned patient's call today (10/28/08). She reports she had blood shot eyes with a light yellow discharge in each X 5 hours after taking INFLUENZA vaccine. MSO, had elevated flu like symptoms. Vaccine received 10/27/08. Felt better this AM but did F/U with PCP - today. She was diagnosed with possible allergic reaction to Flu vaccine - but has also given prescription for antibiotic for possible eye infection. Received steroid injection. Also  injection site for flu vaccine is OK. Recommended f/u with PCP.									Y	10/27/2008	10/27/2008	0	Unknown	OTH	UNK	XALATAN	None reported	None reported			1						1	Eye discharge; Influenza like illness; Ocular hyperaemia	FLU3~PARKDALE PHARMACEUTICALS~U2831AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA		Influenza
0330460	10/28/2008	NV	80.0	80		F	10/23/2008	After vaccine, band aid applied about 2:00 afternoon + I went home when band aid taken off about 9:00 pm upper arm swollen + Black + Blue over area where vaccine applied was about 2 inches in with; a puncture wound also observed.  It is now Oct 23-08 and Black + Blue turning color; its still widely exists.									U	10/10/2008	10/10/2008	0	None	OTH	OTH	PRINIVIL;  LEVOXYL;  FURESAMIDE; ASTEC	None	High Blood Pressure;  Low Thyroid;  Arteriosclerosis			1						1	Injection site discolouration; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~7+~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0328784	10/29/2008	CA	70.0	70		M	10/29/2008	Patient broke out in hives under arm pits, lower abdominal and groin area. Patient took Benadryl that evening for the itch. Patient's symptoms resolved.									Y	10/15/2008	10/15/2008	0		OTH	OTH	Clopidogrel, Omeprazole, Propafenone, Bupropion, Lisinopril, Simvastatin, Trazodone, Multivitamin, Diltiazem, Aspirin, Ibuprofen		Atrial Fibrillation, Neurofibroma, Basal Cell Carcinoma, Actinic Keratoses, Sleep Apnea, CAD, HTN, DJD, Hyperlipidemia, and Depression			1						2	Urticaria; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881294P~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0330166	10/29/2008	IN	65.0	65		F	10/26/2008	Around 4 hrs after receiving AFLURIA vaccine I felt dizzy. I had some memory loss. I felt anxious, tingling lips, tongue, and fingers. I called the pharmacist who told me to call my doctor. he wasn't in office. At their urging, I went to the Local Urgent Care. Got an EKG, CBC, chemistry blood test.  Urgent Care Dr. didn't believe it was reaction to the vaccine. Dr tough it might be sugar drop, I disagree. It never happened before or since.				Y					Y	10/16/2008	10/16/2008	0		OTH	OTH	I Take daily : CRESTOR; NORVASE; MECLAZINE; PROTONIX	None	Fluoresceine Dye; TOPRAL; N-SAIDS Aspirin; TALWIN; Sulfa; LEVAQUIN			1						2	Amnesia; Asthenia; Blood glucose decreased; Blood test; Electrocardiogram; Amnesia; Anxiety; Dizziness; Electrocardiogram; Full blood count; Laboratory test; Paraesthesia; Paraesthesia oral	FLU3~CSL LIMITED~02349111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|FLU3~CSL LIMITED~33332000801~1~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~2	USA	Emergency room visit	Influenza
0330510	10/29/2008	OH	54.0	54		F	10/24/2008	Red eyes.									Y	10/16/2008	10/16/2008	0		PVT	PVT						1						1	Ocular hyperaemia	FLU3~SANOFI PASTEUR~U2767AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330511	10/29/2008	OH	49.0	49		F	10/24/2008	Red eyes.									Y	10/15/2008	10/15/2008	0		PVT	PVT						1						1	Ocular hyperaemia	FLU3~SANOFI PASTEUR~U2767AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330512	10/29/2008	OH	52.0	52		F	10/24/2008	Red eyes.									Y	10/15/2008	10/15/2008	0		PVT	PVT						1						1	Ocular hyperaemia	FLU3~SANOFI PASTEUR~U2767AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330513	10/29/2008	PA	27.0	27		F	10/15/2008	Patient was inadvertently given 1ml of influenza vaccine instead of 0.5ml dose. Pt reported arm was red at injection site for a few days, but has now resolved.									Y	09/30/2008	09/30/2008	0		PVT	PVT			Patient is pregnant. Was 11 wks 1 day when vaccinated.			1						1	Incorrect dose administered; Injection site erythema	FLU3~SANOFI PASTEUR~U2758AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330514	10/29/2008	OH	59.0	59		F	10/24/2008	Red eyes.									Y	10/18/2008	10/18/2008	0		PVT	PVT						1						1	Ocular hyperaemia	FLU3~SANOFI PASTEUR~U2767AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330515	10/29/2008	CA	0.8	0	.8	U		Urticaria (Torso & Extremities) starting near injection site - No Hx of egg or latex allergy rash resolving.				Y						10/20/2008	10/20/2008	0		PUB	PUB	None	No	None			1						1	Injection site urticaria; Urticaria	FLU3~SANOFI PASTEUR~UT2783GA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330516	10/29/2008	NV	55.0	55		F	10/24/2008	Patient suddenly lost voice, called M.D. & was told to take BENADRYL lost voice over 5-10 minute period resolution 4 hrs. after BENADRYL.									Y	10/23/2008	10/23/2008	0		OTH	PUB		None				1						1	Aphonia	FLU3~SANOFI PASTEUR~U2771AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330517	10/29/2008	FL	62.0	62		F	10/23/2008	Patient presented at the pharmacy on October 23, 2008 complaining of some redness and swelling near injection site about 4 inches in length and 2 inches in width. The patient was advised to continue applying cold compresses to area and instructed by the RPH to use and OTC antihistamine. The area was marked placing for dots at each corner and the patient was informed that if the area continued to grow, to contact her physician or ER immediately. VAERS completed. Patient was advised if any further problems, either contact PCP or visit ER. Documentation added to person's allergy profile.									Y	10/20/2008	10/21/2008	1		OTH	PVT	Unknown	None	None			1						1	Injection site erythema; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330518	10/29/2008	CA	36.0	36		F	10/23/2008	Local reaction at injection site. Mild symptoms of anxiety angioedema, diaphoretic.				Y					U	10/23/2008	10/23/2008	0	Breast feeding - Received Thimenisol Free	PUB	PUB	None	None	Hx of Asthma			1						1	Angioedema; Anxiety; Hyperhidrosis; Injection site reaction	FLU3~SANOFI PASTEUR~U278644~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330519	10/29/2008	IL	57.0	57		F	10/23/2008	Pt received Flumist and it is not indicated for her age. Patient had a few sores in her nose which promptly cleared up.									Y	10/03/2008	10/05/2008	2		OTH	PVT	Clarithromycin; Prednisone; Azmacort; Metoprolol; Singulair; HCTZ 25mg		Asthma; HBP			1						1	Inappropriate schedule of drug administration; Nasal mucosal disorder	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0330520	10/29/2008	IL	82.0	82		F	10/21/2008	Patient's (R) arm swelled from below elbow up to shoulder. Swelling started a couple of hours after shot. Patient has been taking TYLENOL and putting heat on it.									N	10/19/2008	10/19/2008	0		OTH	OTH						1						1	Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89880~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0551X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330521	10/29/2008	MN	43.0	43		F	10/22/2008	Hives on Lower Back (No temperature) BENARYL cream & BENADRYL tabs Hives would only resolve w/BENADRYL tabs, cream alone did not help completely.									Y	10/08/2008	10/09/2008	1	None	OTH	OTH		None	Percaet allergy			1						1	Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA167AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330522	10/29/2008	MD	12.0	12		F	10/29/2008	Feeling faint, pale skin color, dry mouth, seeing stars, feeling weak.									Y	10/24/2008	10/24/2008	0		PVT	PVT		None	None			1						1	Asthenia; Dizziness; Dry mouth; Pallor; Photopsia	FLUN3~MEDIMMUNE VACCINES, INC.~5005411~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0229X~1~IM~RA~HPV (GARDASIL)~1|VARCEL~MERCK & CO. INC.~1189X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0330523	10/29/2008	VA	39.0	39		F	10/27/2008	Was given vaccine at 1:45PM T: 97.5. Began feeling wheezy/tight chest at 3PM. No SOB. Continued normal activities by 5PM eyes became extremely bloodshot itchy, painful and very mucous filled. When I pressed on top or bottom of eyes copious amounts of yellow mucous. Eyes continued to be painful, swollen and red. Nose became red and productive cough developed. Took 25mg BENADRYL. Symptoms became manageable. That night had 1 episode of n & vomiting and achy. Next day woke feeling better and no signs and symptoms. Was if it never happened.									Y	10/22/2008	10/22/2008	0		PVT	PVT	ADDERALL 60mg	None	None			1						1	Chest discomfort; Erythema; Eye discharge; Eye pain; Eye pruritus; Eye swelling; Ocular hyperaemia; Pain; Productive cough; Vomiting; Wheezing	FLU3~SANOFI PASTEUR~U2762AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330525	10/29/2008	NJ	53.0	53		F	10/22/2008	Redness, swelling and blisters.									Y	09/23/2008	09/24/2008	1		PUB	PVT						1						1	Blister; Erythema; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA366CA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0962U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330526	10/29/2008	NY	32.0	32		F	10/23/2008	Dizzy, strong smell of medicine/metal, nausea, numbness hands, fingertips & lips.				Y					Y	10/23/2008	10/23/2008	0		PVT	UNK		No	Does have allergies to medication			1						1	Dizziness; Dysgeusia; Hypoaesthesia; Hypoaesthesia oral; Nausea; Parosmia; Urticaria	FLU3~SANOFI PASTEUR~U2754AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330528	10/29/2008	NE	47.0	47		M	10/27/2008	Diaphoretic, body aches, dry cough, low grade fever. Petechiae bilaterally lower legs and to po & feet. HTN.				Y					U	10/23/2008	10/23/2008	0		OTH	PVT	Atenolol	None	Hypertension			1						1	Cough; Hyperhidrosis; Hypertension; Pain; Petechiae; Pyrexia	FLU3~SANOFI PASTEUR~U2766AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330529	10/29/2008	MT	42.0	42		F	10/27/2008	Flu shot 10-23-08 0800. By noon wheezing, anxious SOB, heart racing. 3PM Flu-like achy & burning at inject. site - Reports no redness, swelling or heat at site. 1st Flu shot ever. Full recovery by Mon.									Y	10/23/2008	10/23/2008	0		PVT	PVT	None	None	PCN, seasonal	None~ ()~~0.00~In Patient|None~ ()~~0.00~In Sibling|None~ ()~~0.00~In Sibling		1						1	Anxiety; Dyspnoea; Influenza like illness; Injection site irritation; Palpitations; Wheezing	FLU3~SANOFI PASTEUR~U2752AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330530	10/29/2008	MT	58.0	58		F	10/27/2008	1hr after shot felt hot & nauseous progressing to 102 F, body aches, stomach ache, chills, weak. Weak next day & then fine.									Y	10/20/2008	10/20/2008	0		PVT	PVT		None	None			1						1	Abdominal pain upper; Asthenia; Body temperature increased; Chills; Feeling hot; Nausea; Pain	FLU3~SANOFI PASTEUR~U2752AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330531	10/29/2008	MI	48.0	48		F	10/24/2008	4 x 4 reddened hard area around admin site without        streaking, lymphadenopathy, or fever.									Y	10/22/2008	10/25/2008	3	None	PUB	PVT	None	None	None			1						1	Injection site erythema; Injection site induration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89982~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330532	10/29/2008	MI	45.0	45		F	10/25/2008	A couple of hours after shot - difficulty breathing, paleness, chills, weakness, headache, sore muscles, symptoms lasted about a day + 1/2.									Y	10/16/2008	10/16/2008	0		PUB	PVT		No	No			1						1	Asthenia; Chills; Dyspnoea; Headache; Myalgia; Pallor	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330533	10/29/2008	OH	47.0	47		F	10/26/2008	Fever, hoarseness, coughing, swelling of the eyes + throat, fast hart beat.				Y					Y	10/22/2008	10/22/2008	0	Blood Test - 10/22/2008	PUB	PUB		None	None			1						1	Blood test; Cough; Dysphonia; Eye swelling; Heart rate increased; Pharyngeal oedema; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0330534	10/29/2008	NJ	39.0	39		F	10/24/2008	Immunized 10/17/08 at Health Fair after 1/2 she had rash on legs/arms/chest and lips swelled. No medical eval. Pt was a nurse who took BENADRYL every 6  Without further problems previously received flu shot without problem. Reports Increasing general hypersensitivity over the last few years.									Y	10/17/2008	10/17/2008	0	None	PVT	PVT	PROTONIX	None	Quindones, Latex, tropical fruits, tomatoes + ZANTAC			1						1	Food allergy; Hypersensitivity; Lip swelling; Rash	FLU3~SANOFI PASTEUR~U2743AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330535	10/29/2008	ND	49.0	49		F	10/25/2008	Pt developed hives going up the arm and neck- stated swelling of left ear, patient called facility on 10/23/08 and took Claritin 10mg after that no more hives, swelling, etc. Stated had same reaction with PCN and Sulfa.									Y	10/22/2008	10/22/2008	0		OTH	PVT			Penicillin and Sulfa allergy			1						1	Auricular swelling; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA168AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0330536	10/29/2008	TX	29.0	29		F	10/23/2008	Racing heart clenching jaw difficulty speaking dry mouth The patient was given BENADRYL Oral Capsule 25mg by mouth now and every 6 hrs as needed symptoms children TYLENOL chewable 80mg 4 by mouth.				Y					Y	10/14/2008	10/14/2008	0		PVT	PVT			Allergies PREDNISONE - HA - ADHA, Muscle Spasm, Obsessive, Raynaud's Syndrome			1						1	Dry mouth; Palpitations; Speech disorder; Trismus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88910~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0330537	10/29/2008	WA	5.0	5		M	10/24/2008	Phone call from parent: described - face very red,itching scalp, hives on legs and stomach; chills; no respiratory distress, no swelling face/lips. (Parents noticed the red face and itchy scalp shortly after leaving MD office then called from home about 50 minutes later regarding rest of signs/symptoms - hives/chills that had started. Going to give BENEDRYL. Writer caller parent at home 5:30PM 10/23/08 to see how patient was doing. Mom said he seemed less red in face, not chilling as much. Waiting for dad to get home with BENEDRYL. 10/24/08 9:00AM phone call to mom who said patient fully recovered. Did fine last evening. Had only 1 dose BENEDRYL.									Y	10/23/2008	10/23/2008	0	None	PVT	PUB		None	None	None~ ()~~0.00~In Patient|None~ ()~~0.00~In Sibling		1						1	Chills; Erythema; Pruritus; Urticaria	DTAP~SANOFI PASTEUR~C2957AA~5~IM~UN~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2803AA~5~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A1060~5~IM~UN~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0907X~2~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0994X~2~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0330538	10/29/2008	SC	63.0	63		F	10/23/2008	On 10.22.08. Pt developed (L) arm upper part papular rash. Slightly itchy. No spreading. Given VISTARIL PM.									U	10/20/2008	10/22/2008	2	None	PUB	PUB	LOTENSIN/HCTZ, MVI	No acute illness / HTN	HTN			1						1	Pruritus; Rash papular	FLU3~SANOFI PASTEUR~U2806AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~055UU~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330539	10/29/2008	FL	64.0			F	10/23/2008	30 minutes after flu shot given, patient noticed arm swelling from deltoid muscle down to bicept muscle. She came back to pharmacy for advice. Pharmacist have pt sit in waiting room w/feet prob up. 2 BENADRYL caps given + swelling stop. RPH drove pt home. Pt repeated 2 more doses of BENADRYL.									Y	10/22/2008	10/22/2008	0	None	OTH	UNK	None	Patient fell recently + hurt knee	Allergic to PENNICILLIN, Pt recently fell + hurt knee.			1						1	Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330541	10/29/2008	TX	6.0	6		F	10/28/2008	Purpura Rash began 10/18/08 progressed to buttocks through the week; mild discomfort to knees, legs. Ultimately, diagnosed with Henoch-Schonlein Purpura. 12/9/09 Medical records received for date 10/24/08 to 11/17/08. DX: 10/24/08 purpuric rash suspect HSP. Parents c/o pt w/ rash on legs up to buttocks x1wk, fever. Parents state flumist x8days ago. Assessment: mild throat erythema, purpura. F/u appt 10/28/08 showing improvement. OV 10/29/08 DX: viral illness. Presented w/ fever, sore throat, cough. 11/5/08 f/u rash HSP. DX: HSP, UTI. Presented w/ new crop of rash on leg/knee, knee pain, stomach pain. Assessment: throat erythema, purpura rash. UA(+) protein, leukocytes. OV11/17/08 f/u appt for purpura. Assessment: WNL, no purpura, HSP resolving.				Y					Y	10/16/2008	10/18/2008	2	CBC; BMP; UA; PT/PTT; Immunoglobulin; Complement C3  12/9/09 Medical records received for date 10/24/08 to 11/17/08 Diag/Labs: UA (+)protein, leukocytes, urine culture(+), rapid strep(-).	PVT	PVT		None	None			1						1	Arthralgia; Complement factor C3; Full blood count; Henoch-Schonlein purpura; Immunology test; Metabolic function test; Prothrombin time; Purpura	FLUN3~MEDIMMUNE VACCINES, INC.~500563P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0330542	10/29/2008	WI	0.5	0	.5	F	10/28/2008	Receives immunizations 10/23/08.  Developes urticaria 10/24/08, also has fever & loose stools.  Family members had loose stools the previous week.									Y	10/23/2008	10/24/2008	1	None	PVT	PVT	None	None	None			1						1	Diarrhoea; Pyrexia; Sick relative; Urticaria	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B173AA~UNK~UN~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2758AA~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C71975~UNK~UN~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1033X~UNK~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0330543	10/29/2008	NY	45.0	45		F	10/29/2008	Nausea, Shakiness, hives on Face, upper chest, and back began 2 hrs. after vaccination. BENADRYL by mouth taken; no further progression of symptoms until hours later when more hives appeared.									Y	10/28/2008	10/28/2008	0	None	PUB	PVT	ADVAIR for asthma prn	denies	allergy: Sulfa, ? Erythromycin	denied~ ()~~0.00~In Patient		1						1	Nausea; Tremor; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88635~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330544	10/29/2008	NY	43.0	43		F	10/29/2008	15 min. after vaccination, complained of vaccinated arm felt numb, then had numbness of face, cheek, and tongue, later in neck. She called her Neurologist, as she has a brain tumor and has also had seizures years ago. Symptoms of today resolved without treatment 10-20-2008.									Y	10/20/2008	10/20/2008	0	None	PUB	PVT	TOPAMAX	has brain tumor; followed by MD	Allergy to PCN	None~ ()~~0.00~In Patient		1						1	Hypoaesthesia; Hypoaesthesia facial; Hypoaesthesia oral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88635~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330545	10/29/2008	KS	4.0	4		F	10/28/2008	(1) Swelling at injection site (2) warm to touch (3) mother gave patient BENADRYL (4) hives				Y					Y	10/24/2008	10/25/2008	1	None	PVT	PVT	ZYRTEC; HYDROCORTISONE	None	non physician diagnosed; mother reported allergy to fish; eczema	None~ ()~~0.00~In Patient		1						1	Feeling hot; Injection site swelling; Urticaria	FLU3~SANOFI PASTEUR~U2805AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330549	10/29/2008	OH	36.0	36		M	10/29/2008	Pt got a Meningococcal shot in Lt Del and a FLUZONE and PNEUMOVAX in Rt Del, Pt then 7 days later came into office with lump on Rt side of neck with no redness or tenderness.									Y	10/21/2008	10/22/2008	1	None	PVT	UNK		None	None			1						1	Neck mass	FLU3~SANOFI PASTEUR~U2756AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2633AA~UNK~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PNC~PFIZER\WYETH~0961U~1~IM~RA~PNEUMO (PREVNAR)~1	USA		Influenza
0330558	10/29/2008	ME	13.0	13		M	10/27/2008	515 Child not breathing at home - brought to ED by POV. 525 Arrived in ED, full arrest at that time. Vitals monitor. 0544 ETT placed, Epi. 11/3/08-records received from ED for DOS 10/25/08-presented to ED dyspnea, unresponsive ventricular fibrillation. At home acutely SOB  6/23/09-death certficate and autopsy report received-COD Status asthmaticus. Lymphocytic bronchitis.	Y	10/25/2008							N	10/13/2008	10/25/2008	12	K, 5.2; Na, 150; Cl, 108; Alk phos, 157; Lymp, 45.3; Neut, 35; EOS, 10	UNK	UNK		11/3/08-records received-completed prednisone taper day prior after Flumist.	Asthma, Nuts 11/3/08-records received- PMH-Multiple allergies. Asthma. Lung disease.			1						1	Blood alkaline phosphatase normal; Blood potassium increased; Blood sodium increased; Eosinophil count increased; Lymphocyte count increased; Neutrophil count decreased; Respiratory arrest	FLUN3~MEDIMMUNE VACCINES, INC.~500536P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Results in Death	Influenza
0330562	10/29/2008	TX	51.0	51		F	10/29/2008	Pt stated at 9 p.m. she experienced tightening in her chest, followed by swelling of the throat, minimizing her airway. The episode lasted 4 1/2 hours. Pt. did not seek medical treatment.									Y	10/23/2008	10/23/2008	0		OTH	OTH	Estrogen					1						1	Chest discomfort; Pharyngeal oedema	FLU3~SANOFI PASTEUR~U2752AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330563	10/29/2008	IA	58.0	58		F	10/29/2008	Injection given Monday 27Oct08. Employee c/o left facial numbness and left neck numbness starting at 1000 this am. No weakness. No swelling. PEARL. Per follow-up: 27Jan09. Patient went to her doctor and it was determined my him that she was not having a reaction to influenza immunization.				Y					U	10/27/2008	10/29/2008	2		OTH	OTH						1						1	Hypoaesthesia; Hypoaesthesia facial	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA208AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0330564	10/29/2008	CO	76.0	76		F	10/29/2008	Within 24 h. pt broke out in rash. All over body. Called me on 10/28 she has been taking BENDRYL and is better. Rash on legs, thighs, arms; chest.									Y	10/22/2008	10/22/2008	0		OTH	PVT						1						1	Rash generalised	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~09971~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330565	10/29/2008	WA	69.0	73		F	10/27/2008	Fever, swelling at site of injection, redness pain and nausea.				Y					N	06/18/2008	06/19/2008	1		OTH	OTH						1						1	Erythema; Injection site swelling; Nausea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0962U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0330570	10/29/2008					U	10/29/2008	On 16 OCT 2008 we received the following information from a physician: It was reported that multiple patients developed bloodshot of eyes and gait loss after vaccination with Influenza virus vaccine (manufacturer unknown).  No further information available.  Seriousness criterion: medically significant.  Causality: insufficient data (the amount of data is not sufficient to assess this case).  Expectedness assessment according to label: The reported symptoms are not expected after vaccination with BEGRIVAC, FLUVIRIN, AGRIPPAL and FLUAD.  No change in benefit-risk-ratio.  No measures necessary.									U					OTH	OTH	No other medications	Unknown			MA20082493	1						1	Abasia; Ocular hyperaemia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330582	10/29/2008	AR	64.0	64		F	10/29/2008	Large area of erythema and warmth surrounding vaccine site.									Y	10/27/2008	10/28/2008	1		PUB	PVT						1						1	Injection site erythema; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA171AA~4~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0330584	10/29/2008	MO	59.0	59		M	10/29/2008	Nausea with vomiting and a fever of 103									U	10/14/2008	10/14/2008	0		MIL	MIL	ALLOPURINOL 300MG TAB                      ASCORBIC ACID 500MG TAB                    EPI-PEN 0.3MG/0.3ML INJECTOR               FERROUS SO4 325MG TAB UD                   FUROSEMIDE 40MG TAB                        HYDROCORTISONE 1% CREAM		Allergies: Penicillin, Oxybutynin, Simvastatin, MSG, Diltiazem			1						1	Nausea; Pyrexia; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881326p~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330585	10/29/2008	GA	36.0	35		M	10/29/2008	Aproximately 1-2 minutes after receiving the Flu Vaccine Patient stated not feeling well. Assisted promptly in lying down. BP drastically dropped,( non audible) patient looked very pale and diaphoretic. Lost conciousness for at least 10- 15 second. Administered Epinephrine 0.3 mg IM. Patient responded well. BP went up to 100/60. Patient able to communicate with his wife about incident. Left to East side medical ER walking accompagned by EMT staff. FU later , patient declined going to ER as stated by wife he is doing fine but kind of shaky. Called again this AM . According to wife patient is doing fine									Y	10/28/2008	10/28/2008	0		UNK	UNK		NA	Allergy to Antihistamine			1						1	Blood pressure decreased; Hyperhidrosis; Loss of consciousness; Malaise; Pallor; Tremor	FLU3~SANOFI PASTEUR~U2831AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330586	10/29/2008	OH	26.0	26		F	10/29/2008	Hives, itching, swollen tongue, swollen eyes, weakness, wheezing, swollen throat, tiredness				Y					U	10/11/2008	10/11/2008	0		UNK	PVT	none	none	asthma, allergic to amoxicillan			1						1	Asthenia; Eye swelling; Fatigue; Pharyngeal oedema; Pruritus; Swollen tongue; Urticaria; Wheezing	FLUX~UNKNOWN MANUFACTURER~unknown~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0330587	10/29/2008	OK	15.0	15		F	10/29/2008	Patient was seen 10/16/08 for Well Teen Exam, given Gardasil and flu shot. Patient developed tremors, weaknesss, decreased sensation, hysteria on 10/25/08, went to ER had extensive lab, drug screening and CT of head - all WNL.  Followed up with PCP on 10/27/08 - inital neuro exam showed decreased sensation bilateral hands and grip strength and abnormal gait.  Patients right leg appeared weak with tremors primarily on right side.  Patient appeared to be depressed.  Patient has follow-up on 10/30/08, MRI of brain and neck pending, neuro consult also pending. 12/11/08-records received-office visit 11/8/07-requested testing for disease, vomited day before C/O breast pain left side times 2 days, C/O bumps in vaginal area times 2 weeks. Denies sexual activity. Assessment:URI. 10/16/08 C/O stuffy nose. 10/27/08C/O tremors shaking onset began Friday. DX hysteria with tremor.  Dragging right foot. 10/20/08. Improved denies shaking weakness. Does not remember events of Friday.				Y					N	10/16/2008	10/25/2008	9	CT of head, drug screen and lab - all WNL 12/11/08-records received-CT no abnormality. MRI of brain pending.	UNK	UNK	None	None	None			1						1	Asthenia; Computerised tomogram normal; Conversion disorder; Depression; Drug screen negative; Gait disturbance; Grip strength decreased; Hemiparesis; Laboratory test normal; Neurological examination; Nuclear magnetic resonance imaging; Sensory loss; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8788202~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HPV4~MERCK & CO. INC.~0947X~1~IM~RA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0330588	10/29/2008	IL	70.0	70		F	10/29/2008	Dizziness, breathing difficulty, back pain, increased heart rate. Called 911. Transferred per ambulance to Hospital. In transit received Benadryl.				Y					Y	10/28/2008	10/28/2008	0	UNKNOWN	UNK	UNK	None	None	None			1						1	Back pain; Dizziness; Dyspnoea; Heart rate increased	FLU3~SANOFI PASTEUR~U2743AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0669X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0330589	10/29/2008	SC	32.0	40		F	10/29/2008	Rash/edema @ injection site followed by generalized rash & severe itching. Claritan 10 mg po stat, Hydrocortisone ungt applied & ice applied to injection site.									Y	10/29/2008	10/29/2008	0	None	PVT	UNK	Ambien, Topomax, Darvocet, Lyrica	Denies	Fibromyalgia, Migraines	None~ ()~NULL~~In Patient|Denies~ ()~NULL~~In Sibling1|Denies~ ()~NULL~~In Sibling2		1						1	Injection site oedema; Injection site rash; Pruritus; Rash generalised	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88129~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330590	10/29/2008	TX	17.0	9		M	10/29/2008	client screened,nocontraindications,vaccines given,client stood up,moved to stand behind parents who took turns getting flu shots, client momentarily lost consciousness,slid to carpeted floor,immediately opened eyes,skin sweaty, BP 116/58,P60,R20,PERRLA,had not eaten all day.no tx. parents declined medical tx.No injuries.									Y	10/21/2008	10/21/2008	0	none	PUB	PUB	NONE	NONE	NONE			1						1	Fall; Hyperhidrosis; Loss of consciousness	FLU3~SANOFI PASTEUR~U2789CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAB259AA~UNK~IM~LA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2636AA~UNK~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C3027AA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0330591	10/29/2008	MN	3.0	3		F	10/29/2008	RT ARM IS SWOLLEN AND REDDENED AND WARM TO TOUCH.9CM BY 7CM IS REDDENED AREA ON DELTOID									Y	10/27/2008	10/28/2008	1	NA	PUB	UNK	NA	NA	NA		SANOFI PASTEUR	1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2791EA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330592	10/29/2008	CA	0.33	0	.4	F	10/29/2008	Patient given flu vaccine at age 4 months. Patient did not experience any adverse effects.									Y	10/14/2008	10/14/2008	0	none	PVT	PVT	none	none	none			1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~unknown~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330595	10/29/2008	CA	51.0	51		F	10/29/2008	DEVELOPED A RASH ON STOMACH THE NEXT DAY, THEN ADVANCED TO CHEST, ARMS, NECK, FACE AND GROIN AREAS, ON THE THIRD DAY. THE FORTH DAY I WAS DIZZY MOST OF THE DAY. I TOOK BENEDRILS TABLETS EACH OF THE DAYS AS DIRECTED.  MY SKIN WAS ITCHY FOR 5 DAYS, STILL A LITTLE TODAY, THE 6TH DAY.									Y	10/23/2008	10/24/2008	1		UNK	UNK	NONE	NONE	I'VE HAD AN ALLERGIC REACTION TO A COMBO OF PENICILIN AND COLD PILLS. I'M NOT ALLERGIC TO EGGS, BUT, I DID HAVE A HARD-BOILED EGG TWO HRS BEFORE THE SHOT AND ANOTHER ONE THE NEXT MORNING.			1						1	Dizziness; Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~UNKNOWN~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330596	10/29/2008	MA	28.0	28		F	10/29/2008	10/27/08 mid-morning time of administration flu vaccine to left deltoid.  Upper arm achiness noted that night.  Fever (temp not taken) with chills during the night w/ malaise lasting into 10/28/08.  Ipsilateral axillary lymphadenopathy note 10/28/08 causing limitation in range of motion; axillary pain.  No erythema, hyperthermia or swelling at injection site.  Symptoms diminishing on 10/29/08 w/ oral temp 100.6F, mild-moderate LAD w/ tenderness, malaise.  Counselled to return home from work to continue Tylenol, fluids and rest w/ follow-up in EHS on 10/30/08 at 8 AM.										10/27/2008	10/27/2008	0		PUB	PVT	none	none	none			1						1	Axillary pain; Body temperature increased; Chills; Joint range of motion decreased; Lymphadenopathy; Malaise; Pain in extremity; Pyrexia; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA364BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330597	10/29/2008	OR	49.0	49		F	10/29/2008	rash located over area of injection of pneumonia vaccination (23) 3-4 inches in diameter, lump larger than a quarter, temp 100.2 and sore throat ~36 hours after injection.										10/27/2008	10/28/2008	1		UNK	UNK		copd	emphysema, migraines, seasonal allergies, hypercholesteremia			1						1	Body temperature increased; Emphysema; Injection site rash; Injection site swelling; Oropharyngeal pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0330598	10/29/2008	ND	43.0	43		M	10/29/2008	17 Oct 08, Pt developed acute onset of substernal chest pressure at rest.  Pressure became a sharp pain that worsened with deep breathing and also radiated down the left arm.				Y					Y	10/07/2008	10/13/2008	6	PT's symptoms and EKG findings are most C/W mild pericarditis and a viral syndrome, most likely as a result of the smallpox vaccine.  We will get an echocardiogram to assess for a pericardial effusion and to ensure cardiac function is normal.	MIL	MIL		None	None	NA~ ()~~0.00~Patient|NA~ ()~~0.00~Sibling|NA~ ()~~0.00~Sibling		1						1	Chest discomfort; Chest pain; Echocardiogram; Electrocardiogram abnormal; Pericarditis; Vaccination complication; Viral infection; Chest discomfort; Chest pain; Electrocardiogram abnormal; Pericarditis; Vaccination complication; Viral infection	ANTH~EMERGENT BIOSOLUTIONS~FAV174~2~SC~UN~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500549A~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB596CA~3~IM~UN~HEP B (ENGERIX-B)~1|SMALL~EMERGENT BIOSOLUTIONS~UNK~3~ID~LA~SMALLPOX (ACAM2000)~1|TYP~SANOFI PASTEUR~A09233~7+~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|ANTH~EMERGENT BIOSOLUTIONS~~UNK~UN~UN~ANTHRAX (BIOTHRAX)~2|FLUN3~MEDIMMUNE VACCINES, INC.~500549A~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB8596CA~UNK~UN~UN~HEP B (ENGERIX-B)~2|SMALL~EMERGENT BIOSOLUTIONS~ACAM2000~UNK~ID~UN~SMALLPOX (ACAM2000)~2|TYP~SANOFI PASTEUR~A09233~UNK~UN~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~2	USA	Emergency room visit	Influenza
0330599	10/29/2008	NJ	28.0	28		M	10/29/2008	Received Flu mist 10/27 overnight into 10/28.  Developed abrupt onset of aches, chills, sore throat and fever approximately 11pm-midnight 10/28.  no known exposures to illness or influenza.									U	10/28/2008	10/28/2008	0	Rapid strep test negative   Throat culture pending	PUB	UNK	paxil cr 20mg	none	Anxiety disorder successfully treated with Paxil CR.  recent otitis externa treated to resolution 2 weeks ago with cipro otic gtts.			1						1	Chills; Culture throat; Oropharyngeal pain; Pain; Pyrexia; Streptococcal identification test; Streptococcal identification test negative	FLUN3~MEDIMMUNE VACCINES, INC.~500567P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0330600	10/29/2008	CA	54.0	54		F	10/29/2008	Three hours after injection, pt. c/o fever of 104.8, weakness, shaky, joints ached, chills.  States her legs buckled and I couldn't walk. She stated her joints locked up and she was shaking,like I was having a convulsion.  Threw up once, stated breathing hurt.  Fever continued for approximately 2-3 days, at around 102 degrees.									Y	10/21/2008	10/21/2008	0	Hx. of RA.	PUB	PVT	Don't know	RA	RA	Fever, chills~Influenza (Seasonal) (no brand name)~UN~52.00~In Patient		1						1	Arthralgia; Asthenia; Chills; Dyspnoea; Gait disturbance; Limb discomfort; Pyrexia; Tremor; Vomiting	FLU3~SANOFI PASTEUR~U2756AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330601	10/29/2008	CA	63.0	63		M	10/29/2008	Patient reported a spot on chest area that was red, blotchy and itchy.									Y	10/23/2008	10/24/2008	1		UNK	UNK	NONE		NKA, Vitamin D deficiency, Osteopenia, Insomnia, and Diverticulosis			1						1	Erythema; Pruritus; Rash macular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA184AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330602	10/29/2008	CA	79.0	79		M	10/29/2008	Patient reported developing joint pain to his knees, hips, elbows and wrists 24 hours after he had his flu vaccine. Pain level was 10/10. Patient took a morphine and had relief. Pain level was at 5/10 (10/16/08)									Y	10/10/2008	10/11/2008	1		UNK	UNK	Morphine, Isosorbide Dinitrate, Doxycycline, Penicillin, Nitroglycerin, Vicodin, and Seroquel		NKA; TIA, HTN, CAD, Cellulitis, Hematuria, Hypercholesterolemia, Actinic Keratoses			1						1	Arthralgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA184AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330603	10/29/2008	CA	39.0	39		M	10/29/2008	The wife of the patient came into MinuteClinic complaining that her husband develeped hives to bilateral lower extremities 24-48 hours after receiving the Influenza vaccine.  No difficulty breathing , any other symptoms at this time. The rash she reported was painful to him. Follow up received: Within 24 hours of vaccination I experienced hives from the waist down, primarily on the sides of my legs and buttocks.  Within 48 hours they had spread to my stomach and arms.  Today (7 days later) the bumps and redness are gone and all that is left are dots of scabs where the hives were.									U	10/27/2008	10/28/2008	1	Vaccine Administration - Influenze	UNK	UNK	None	No	None			1						1	Pain; Urticaria	FLU3~SANOFI PASTEUR~U2768AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330604	10/29/2008	VA	30.0	30		F	10/29/2008	Had Flu Shot on 10/25/08, symptoms presented within two hours.  Injection site swelled to 5 inches across raised and very hot to touch.  Have taken Benadryl for past two days and the swelling and redness has decreased, however itching and heat remains, however heat is much less.									Y	10/25/2008	10/25/2008	0		UNK	PVT	Clairitin, Birth Control	None.	Allergies to Hazelnuts, pennacillin, sulfur	Similar symptoms~Tetanus Toxoid (no brand name)~1~30.50~In Patient		1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2771AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330605	10/29/2008	VA	33.0	33		M	10/29/2008	TWO DAYS AFTER VACCINES ADMINISTERED DEVELOPED NUMBNESS AROUND RT EYE WITH DIFFICULTY CLOSING RT EYE, DIFFICULTY MOVING RIGHT SIDE LIPS, DISCOMFORT RIGHT TEMPORAL AREA -NO HEADACHE OR LOSS CONSCIOUSNESS. 11/3/08-records received for office visit 10/24/08-Presented with numbness and difficulty to close his right eye. Cannot move well his right side of lips. Discomfort in right side of temporal ear. Possible Bell's Palsy. Office visit 10/30/08-C/O pain severe earache in right ear. Right eye slow movement eye lid, right lip muscle no movement.				Y					N	10/21/2008	10/23/2008	2	CT SCAN-R/O STROKE 11/3/08-records received-CT scan head no abnormality.	MIL	MIL		NONE	SKIN CANCER 2000			1						1	Discomfort; Eye movement disorder; Hypoaesthesia facial	ANTH~EMERGENT BIOSOLUTIONS~FAV148B~2~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197AA~3~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|YF~SANOFI PASTEUR~UF307AB~2~SC~RA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0330607	10/29/2008	OH	24.0	24		F	10/29/2008	3:30 pm Eyes blurry and itching.  Then started wheezing, coughing and shortness of breath.  Eyes very swollen.  Seen in the Emergency Department at 6:25pm.  Given SoluMedrol 125 mg IV, Benadryl 25 mg IV, Pepcid 20 mg IV, Provental Aerosol Rx. Pulse rate 135. 147/85, Pulse Ox 90%. 12/10/08-records received for DOS 10/22/08-DC DX Hypersensitivity reaction to flu shot with late hypersensitivity reaction with potentiating bronchospasm and early anaphylaxis which improved. Presented to ED with breathing complaints and swallowing difficulty.			Y	Y					Y	10/22/2008	10/22/2008	0		UNK	UNK	Birth control	No	Dilaudid, Morphine and Iodine			1						1	Cough; Dyspnoea; Eye pruritus; Eye swelling; Heart rate increased; Oxygen saturation decreased; Vision blurred; Wheezing	FLU3~SANOFI PASTEUR~U2793DA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0330608	10/29/2008	PA	41.0	41		F	10/29/2008	low-grade fever, chills,  malaise, systemic muscle aches, mild abdomenal pain.  Tylenol OTC q 4-6 hr.									Y	10/25/2008	10/28/2008	3		UNK	UNK	otc multivitamin	none	none			1						1	Abdominal pain; Chills; Malaise; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~u2765aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330609	10/29/2008	WI	11.0	11		F	10/29/2008	Had 5 vaccines on 10/27/08.  Today 10/29/08 saw MD d/t R deltoid area with 7.5cm x 7.5cm redness and 7cm X 9cm induration.  No fever or drng from site.  In R arm had Menactra, Boosterix, and Varivax.									U	10/27/2008	10/29/2008	2	none	PVT	PVT		none				1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U2785HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB260AA~UNK~IM~LA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2660BA~UNK~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B024DB~UNK~IM~RA~TDAP (BOOSTRIX)~1|VARCEL~GLAXOSMITHKLINE BIOLOGICALS~1134X~UNK~SC~RA~VARICELLA (VARILRIX)~1	USA		Influenza
0330610	10/29/2008	OR	78.0	78		U	10/29/2008	Pt describes weakness day after flu shot									U	10/28/2008				PVT	UNK						1						1	Asthenia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881175P~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330611	10/29/2008	PA	52.0	52		F	10/29/2008	10-27-08 soreness @ site couple hours after injection; 10-28-08 evening itching at injection site then hives around site; 10-29-08 10 AM hives on legs and back; advised to call PCP for evaluation				Y					U	10/27/2008	10/27/2008	0		PUB	PUB	Armour Thyroid; Klonopin;Zoloft; Cymbalta; Botox injection 10-23-08 for Torticollus; Biaxin and amoxicillan for H. Pylori	none acute, chronic diagnosis and treatment	Torticollus, H. Pylori per patient; no diagnosis given for other meds			1						1	Injection site pain; Injection site pruritus; Injection site urticaria; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88805~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0330612	10/29/2008	MI	26.0	26		M	10/29/2008	Polyarthralgia in hips, knees, shoulders and elbow with moderate severity for 3 days and minimal severity for 3 additional days. Patient used Motrin for pain, which helped mildly.									Y	10/21/2008	10/21/2008	0	n/a	UNK	UNK		None	None			1						1	Arthralgia	FLU3~SANOFI PASTEUR~U2745AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330613	10/29/2008	MO	74.0	74		F	10/29/2008	Unusual arm soreness appearing third or fourth day after administration. After conversation the patient indicated that the extremity had been sore prior to administration. Instructed patient to recontact vacine administrator if problem persists.									U	10/22/2008	10/25/2008	3	none	UNK	PUB	blood pressure medication	none noted	hypertension			1						1	Condition aggravated; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~87923~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330616	10/29/2008	OH	67.0	67		M	10/29/2008	About 4 hrs after shot(9:15pm) runny nose,coughing, drainage thru throat, headache,about 10:00 was chilled and couldn't get warm,eyes ached and crusty, heart rapidly pounding, chest pain, light headed and dizzy.									Y	10/28/2008	10/28/2008	0		PUB	UNK						1						1	Chest pain; Cough; Dizziness; Eye discharge; Eye pain; Feeling cold; Headache; Heart rate increased; Palpitations; Postnasal drip; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~~1~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330617	10/29/2008	OH	70.0	70		F	10/29/2008	severe chills of over 1 hr within 4 hrs of vaccine, severe weakness, slept for about 4 hrs, then fever of 102.7 detected at 7:30pm, general body aches, arm of innoculation extremely sore, tylenol given, temp downward trend for 3 hrs, then upward trend, advil give at 10:30pm, downward trend for 4 hrs, down to 100.0.  normal to low grade fever--99.7 to 100.3, tylenol and advil given for body aches  after this. symptoms and fever continued day of shots and following day.  flu and pneumonia shots given at same time in same arm.  patient has cancer and had a tooth extracted, with no ill affects, the day previous to shots (person admisistering shots was notified. physician office notified of events post innoculation.									Y	10/28/2008	10/28/2008	0		UNK	UNK		treated cancer				1						1	Asthenia; Chills; Pain; Pain in extremity; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0330619	10/29/2008	CA		86		F	10/29/2008	patient had nausea, dizziness and some diarrhea. Had altered mental status, was taken to the hospital where she was given IV fluids and was dischared. The discharge diagnosis was dehydration and UTI. She had to be re-admitted due to an observed level of altered mental status by family members. Hospital would not admit her but wanted to send her to a SNF.				Y					Y	10/23/2008	10/24/2008	1		UNK	UNK						1						1	Dehydration; Diarrhoea; Dizziness; Mental status changes; Nausea; Urinary tract infection	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflla165aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0330620	10/29/2008	IL	32.0	32		F	10/29/2008	Two weeks after receiving the intranasal flu vaccine, Flu Mist, I developed a horrible earache. This turned into paralysis of the entire right side of my face - bell's palsy. I have now been experiencing extreme inner ear pain since the onset of the symptoms - debilitating pain. My r. eye does not close, the right side of my tongue doesn't taste, my face is motionless on the r. side. I was treated with prednisone, a steriod, to reduce inflammation. I was given hydrocodone for the pain, which does nothing to alleviate the pain. I have gone to acupuncture treatment twice a day for the past five days in a desperate attempt to alleviate the pain. 1/28/2010 Recurring pain in inner ear and along the jawline.				Y				Y	N	10/02/2008	10/17/2008	15	I was given an MRI at the Emergency room as well as physical tests for a stroke. I visited a neurologist as well who tested me for bell's palsy as well as underlying MS or lyme disease, of which I had neither.	UNK	UNK						1						1	Ageusia; Ear pain; Facial palsy; Inflammation; Neurological examination abnormal; Nuclear magnetic resonance imaging; Pain in jaw; Abdominal pain; Ageusia; Anorexia; Computerised tomogram normal; Ear pain; Facial palsy; Hyporeflexia; Insomnia; Lacrimation increased; Muscle twitching; Nasopharyngitis; Nausea; Pain; Vertigo; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500547P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500547P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Disabling	Influenza
0330621	10/29/2008	OH	56.0	56		F	10/29/2008	Received the vaccine 8:50 AM, 1 hour after injection stated felt like I had golf ball in my throat, and felt anxious. At 1:30 PM took 800 mg Ibuprofen, 500 mg Tylenol. Sclera of eyes very red, glassy, filmy and face burning. Throat scratchy, and sore, couldn't breath through nose, and voice hoarse. Visited Employee Health, given Claritin 10 mg and Flonase. 7:00 PM states eyes still scratchy, H/A, severe stuffy nose, yellow drainage in corners of eyes. Six years ago had MMR, and got Mumps/Measles. Never had a flu shot in the past.				Y					Y	10/29/2008	10/29/2008	0		PUB	PVT	OTC vitamins, Xanax 0.25 PRN	Unknown	Possible MS			1						1	Anxiety; Burning sensation; Dysphonia; Eye discharge; Eye pruritus; Headache; Nasal congestion; Ocular hyperaemia; Throat irritation; Throat tightness	FLU3~SANOFI PASTEUR~U2753AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330622	10/29/2008	VA	24.0	24		F	10/29/2008	Itching/Hives on neck, shoulders, upper arms, chest, back, abdomen, sides, thighs, and upper buttocks									U	10/28/2008	10/29/2008	1		UNK	UNK		None	None			1						1	Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~Shot #312~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330623	10/29/2008	OK	69.0	69		F	10/29/2008	nausea, wheezing, shortness of breath, whroat swelling, small seizure enroute to hospital, eye redness 12/29/08-records received for DOS 10/29-10/30/08- DC DX: Fever, shortness of breath, rash, probably allergic reaction to flu shot.				Y	Y	1			Y	10/29/2008	10/29/2008	0	cbc,chem 7, pa/lat chest x-ray,	UNK	UNK	cholesterol pill, paxil,lortab	none	n/a 12/29/08-records received-PMH:History of gastroesophageal reflux disease with history of esophageal strictures. hyperlipidemia. Anxiety and depression. Chronic back pain. History of benign tumor. Questionable seizures. Chronic obstructive pulmonary disease			1						1	Chest X-ray; Convulsion; Dyspnoea; Full blood count; Laboratory test; Nausea; Ocular hyperaemia; Pharyngeal oedema; Wheezing	FLU3~CONNAUGHT LABORATORIES~U2811AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0330625	10/29/2008	WA	28.0	28		F	10/29/2008	Pt. had redness at the site day of shot. Two days post immunization she has full body itching, scratching in her throat, redness. Site is bumpy, raised, and warm to touch.									Y	10/27/2008	10/29/2008	2		MIL	MIL	NUVA-RING	None	Seasonal allergies			1						1	Erythema; Injection site erythema; Injection site swelling; Injection site warmth; Pruritus generalised; Throat irritation	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89685~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330626	10/29/2008	MO	82.0			M	10/24/2008	Woke up and felt weak and numb all over tingling sensation in his arms and hands, some on his face. c/o some non-specific chest heaviness, but it is difficult to ascertain from patient if this is new. Just had flu shot yesterday.									U					UNK	UNK						1						1	Asthenia; Chest discomfort; Hypoaesthesia; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881326P~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330627	10/29/2008	MO	59.0			M	10/24/2008	left arm is red, warm, and tender to touch.  States LPN gave him injection at same spot.  running fever and chills.									U					UNK	UNK						1						1	Chills; Injection site erythema; Injection site pain; Injection site warmth; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881326F~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330628	10/29/2008	MO				M	10/24/2008	Rash and hives all over.  Started 30 min after receiving flu shot.									U					UNK	UNK						1						1	Rash generalised; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88132~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330629	10/29/2008	MO	68.0	68		M	10/24/2008	Complaints of right lower chest/rib pain x3 days several days after flu shot.									U	10/11/2008				UNK	UNK						1						1	Chest pain; Musculoskeletal chest pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881326P~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330631	10/29/2008	CA	9.0	9		M	10/29/2008	4 hour after FLUZONE injection had 4 extremity pain with crying. Reported fever but not documented. Hard to walk due to symptoms but seen by MD next day with no visual skin/extremity changes. Will walk but still c/o pain. Reflexes normal.									N	10/28/2008	10/28/2008	0	None	PVT	PUB						1						1	Crying; Gait disturbance; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U2784FA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330632	10/29/2008	MI	73.0	73		U	10/17/2008	Severe pain in arm radiating to neck shoulder and back.									Y	10/16/2008	10/16/2008	0		OTH	PUB	Levothyroxine					1						1	Back pain; Musculoskeletal pain; Neck pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0551X~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330633	10/29/2008	IL	31.0	31		M	10/29/2008	Pt. has a history of seizure disorder. Pt. has a small seizure about 15 mins following flu shot. Recovered and went home.									Y	10/29/2008	10/29/2008	0		OTH	PUB	Unknown	None	Seizure disorder possibly mental handicap			1						1	Convulsion	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89968~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330634	10/29/2008	CA	58.0	57		F	10/29/2008	Edema, severe, painful itching, rash.				Y					Y	10/21/2008				OTH	OTH		None				1						1	Oedema; Pain; Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA366CA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0330635	10/29/2008	MO	62.0	46		F	10/29/2008	4 hours after vaccination pt had some chest heaviness, SOB, abd upset, sore throat, lethargy.									U	10/21/2008	10/21/2008	0		PVT	OTH	None	None	NKDA; Hx Breast CA			1						1	Chest discomfort; Dyspnoea; Lethargy; Oropharyngeal pain; Stomach discomfort	FLU3~SANOFI PASTEUR~A2708AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330636	10/29/2008	IN	46.0			F	10/19/2008	8 days after receiving FLUMIST, became very ill with flu symptoms.									U	10/11/2008				UNK	UNK						1						1	Influenza like illness; Malaise	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0330637	10/29/2008	IN	6.0			F	10/19/2008	Child received FLUMIST 10:00 a.m. Began running a fever of 103 that evening, and for the next four days, with nasal discharge, aches, no appetite.									U		10/11/2008			UNK	UNK						1						1	Anorexia; Pain; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0330639	10/29/2008	VA	1.0	0	1	F	10/29/2008	Patient received varicella , hepatitis A, and pneumococcal (PREVNAR) vaccines 11 days prior to one year birthday (12 mos). No adverse event or reaction occurred.									N	10/28/2008				PVT	OTH		cough; BOM; URI	Hemangioma on lip; GERD; Prematurity			1						1	Inappropriate schedule of drug administration; No adverse event	FLU3~SANOFI PASTEUR~UT2794DA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB257AA~1~IM~LL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~C68312~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0790X~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0330642	10/29/2008	AK	0.9	0	.9	F	10/29/2008	Localized maculopapular mildly erythematous - multiple discrete lesions 2-4 mm clustered in 1 x 2/5 area @ site of influenza vaccine. Rash was not pruritic not vesicles w/o underlying swelling. No tenderness. No systemic symptoms. Improved 24 hr w/ po BENADRYL/ improving after 24 hrs				Y						10/24/2008	10/28/2008	4	Negative food allergy testing (including egg); 9/17/08 - done for other reasons.	PVT	PUB		None	History of re-current OMT; Previous viral syndrome several wheals previously			1						1	Allergy test negative; Injection site rash; Rash erythematous; Rash maculo-papular	FLU3~SANOFI PASTEUR~UT2786GA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330643	10/29/2008	MA	16.0	16		M	10/27/2008	No adverse reaction. Patient is 16 years old. Was given FLULAVAL which is for 18 year olds and older.									U	10/08/2008				PVT	PVT						1						1	Inappropriate schedule of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA1273AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0330644	10/29/2008	MA	3.0	3		F	10/27/2008	No adverse reaction noted. Patient is a 3 yo given FLULAVAL flu vaccine which is indicated for greater than or equal to 18 yo.									U	10/20/2008				PVT	PVT						1						1	Inappropriate schedule of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA173AA~2~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0330645	10/29/2008	MA	13.0	12		M	10/27/2008	No adverse reaction. Patient is a 13 year old given FLULAVAL which is for 18 year olds and older.									U	10/09/2008				PVT	PVT						1						1	Inappropriate schedule of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA173AA~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|VARCEL~MERCK & CO. INC.~1013X~UNK~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0330646	10/29/2008	MA	11.0	11		M	10/27/2008	No adverse reaction. Patient is an 11 year old boy, given FLULAVAL flu vaccine which is for 18 years and older.									U	10/16/2008				PVT	PVT						1						1	Inappropriate schedule of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA173AA~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC528B019AA~6~IM~RA~TDAP (BOOSTRIX)~1	USA		Influenza
0330647	10/29/2008	VA	31.0	31		F	10/26/2008	9:45 AM c/o itching (L) arm at site. BP 120/80. Administered 50 mg BENADRYL IM (L) arm.				Y					Y	10/26/2008	10/26/2008	0		OTH	PUB						1						1	Injection site pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA349CD~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0330649	10/29/2008	IL	8.7	8		F	10/29/2008	Local reaction at injection site 10cm x 10cm.									Y	10/28/2008	10/29/2008	1		PVT	PVT		None	None			1						1	Injection site reaction; Local reaction	FLU3~SANOFI PASTEUR~U2791EA~5~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0159873	10/30/2008	FL	17.0	17		M	10/30/2008	MILITARY PHYSICAL ON 8/31/1964 NOTED PRIOR CASE OF POLIO AS A CHILD 9 YEARS OLD TYPE UKNOWN (infantile Paralysis) 1ST DOSE OPV APPROX 9/5/1964 Reported to SICKBAY 9/7/1964 VERY DIZZY ADMINISTERED APC ( Aspirin, phenacetin, and caffeine) (STAT)    9/12/1964 5 DAYS AFTER 1ST dose OPV Hospitalized  with temperature of 103 symptoms sputum many gram-positive diplococcal in pairs with blood flecking deep breathing with moderate enlargement of cervical lymph nodes an a pulse of 116 beats per minute. Chest exam revealed decreased breath sounds. X-ray revealed right middle lobe pneumonia. A lung infiltrate was noted on an x-ray day after. Hospital coarse treated with Procaine penicillin 600,000 administered intramuscularly every 12 hours.    2ND DOSE OPV 10/16/1964, readmitted to sickbay again ON 10/18/1964  with temperate of 101 having yellowish green sputum diagnosed as bronchitis bilateral bronchi temperature persisted until 10/21/1964 given tetracycline, robitussin, steam. 11/24/1964 date approx Third dose of OPV DD 737 (immunization Certificate Issued) missing from file   12/17/1964 APPROX 21 DAYS OUT OF BOOT CAMP Surgical Console Reported as having considerable leg pain. Involving moderately severe varicose veins in the greater and lesser system Not noted on three prior military exams. No family history noted Venous surgery 1/18/1965 released 2/11/1965 hospitalized 24 days Lidocaine Spinal noted  2/22/65 Reported to sickbay with sudden onset frontal headache face appears slightly flushed trenching to vomit Fiorinal and erythromycin were prescribed .9/14/1965 Reported to sickbay with significant pain in right thigh diagnosed as sprain right thigh 9/18/1965 Reported to sickbay with longitude erythmatose inner aspect of left thigh burning pain.     MEDICAL ISSUES OVER THE NEXT TWO YEARS INCLUDE NUMEROUS INCIDENTS OF FALLING AND TRIPPING, SHOULDER SPRAINS BUMPING INTO TABLES, CHRONIC VARICOSE VEINS, GASTRO REFLUX,  DIGESTIVE ISSUES, GASTROENTERITIS AND A UNEXPLAINED WEIGHT GAIN OF APPROX. 34 LBS IN APPROX 14 MONTHS   TO A  BMI 29.2   TREATED WITH DEXTROAMPHETAMINE SALTS FOR ABOUT 12 MONTHS BY PHYSICAN            Medical records lost for 32 years NPRC Files sent to hospital.					Y				Y	09/05/1964	09/07/1964	2	GRAM STAIN POSITIVE S-PNEUMONIA DIPLOCOCA IN PAIRS	MIL	MIL	PROCAINE PENICILLIN 600000 ADMINISTERED INTERMUSCLAR GLUTEAL	NONE	PRIOR CASE OF POLIO AGE 9 HERNIA AGE 8 REPAIRED ALLERGIES TO RAGWEED			1						3	Bacteria sputum identified; Body temperature increased; Breath sounds abnormal; Bronchitis; Chest X-ray abnormal; Dizziness; Dyspepsia; Erythema; Fall; Flushing; Gait disturbance; Gastroenteritis; Gastrooesophageal reflux disease; Gram stain positive; Haemoptysis; Headache; Joint sprain; Lobar pneumonia; Lung infiltration; Lymphadenopathy; Nausea; Pain; Pain in extremity; Sputum discoloured; Varicose vein; Weight increased	FLUX~UNKNOWN MANUFACTURER~UNKNOWN~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|MEA~UNKNOWN MANUFACTURER~UNKNOWN~UNK~~~MEASLES (NO BRAND NAME)~3|MEN~UNKNOWN MANUFACTURER~UNKNOWN~UNK~~~MENINGOCOCCAL (NO BRAND NAME)~3|OPV~UNKNOWN MANUFACTURER~UNKNOWN~4~PO~MO~POLIO VIRUS, ORAL (NO BRAND NAME)~3|SMALL~UNKNOWN MANUFACTURER~UNKNOWN~UNK~~~SMALLPOX (NO BRAND NAME)~3|TD~UNKNOWN MANUFACTURER~UNKNOWN~UNK~~~TETANUS DIPHTHERIA (NO BRAND NAME)~3	USA	Hospitalisation	Influenza
0270527	10/30/2008	VA	42.0	42		U	10/17/2008	Received FLUMIST 2007 then had severe bronchitis which lead to GI distress w/bloody diarrhea, pain and hospitalization. Received (not documented) FLUMIST 10/10/06 with aches/pains all joint esp knee's/shoulders that evening. Woke next day with severe bilateral ft pain/hurt to walk and continued joint pain-took Motrin w/some relief. Was tired w/nasal congestion and URI s/s. This lasted 1 week w/o resolution then developed cough w/diffuse abd cramping. Went to immunz dept and told this was nl. 10/19 saw PCP for chest tightness, sob, diff lying down, unable to sleep w/o sitting up, worsening cough unrelieved with home Albuterol, had thick clear phlegm. Abd cramping worse, problems eating/drinking due to increased bowel activity/cramps every 15-20 min. Some cramps made her double over. MD put on antibiotics x 5 days, then one week of steroids when stool/diarrhea began smelling foul, temp 101. CT abd showed bowel inflammation/ischemia and stool Guiac + blood. Admitted to hospital x 5 days, c-diff neg and no other cultures done per pt but treated with Flagyl for possible salmonella, K supplements and rehydration for anemia and low K and dehydration. Currently is doing fine w/o problems. Her MD wrote note for FLUMIST exemption, but again was sent by immunz dept for clarification on exemption. I gave temp exempt until I get her medical records to clarify events. She has received IM in past w/o problems so agreed with IM route. Her medical history presentation was first all normal, then with questioning had asthma, chronic sinusitis with dust, dog dander and seasonal allergies, IBS, bowel/bladder problems after MVA w/spinal fusion (resolved except for constipation), anemic, leg jumps at night (not tx'd for), depression, reflux, spleenis mass (under current eval), and monthly oral ulcers (has new braces). Not going to get into some of this as it's not related to the FLUMIST events; but need her records to accurately correlate and causality. She is very happy just to receive IM. She is an oncology nurse. She grew up on a farm in very rural area. They used outhouses with no indoor facilities, grew own food, store items were for staples only (flour to make own bread, etc.), worked pig farm, tobacco, etc.					Y	5				01/03/2007	01/06/2007	3		UNK	UNK			Her medical history presentation was first all normal, then with questioning had asthma, chronic sinusitis with dust, dog dander and seasonal allergies, IBS, bowel/bladder problems after MVA w/spinal fusion (resolved except for constipation), anemic, leg jumps at night (not tx'd for), depression, reflux, spleenis mass (under current eval), and monthly oral ulcers (has new braces).			1						2	Abdominal discomfort; Abdominal pain; Abnormal faeces; Anaemia; Arthralgia; Body temperature increased; Bronchitis; Chest discomfort; Cough; Dehydration; Diarrhoea haemorrhagic; Dyspnoea; Eating disorder; Fatigue; Increased upper airway secretion; Insomnia; Intestinal ischaemia; Nasal congestion; Occult blood positive; Pain; Pain in extremity; Upper respiratory tract infection	FLUN3~MEDIMMUNE VACCINES, INC.~500434P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Hospitalisation	Influenza
0330179	10/30/2008	MI	55.0	55		F	10/27/2008	Arm hurts with movement, (R) arm throbbing for 2 weeks due to flu shot given. Pt. given prescription for FLEXERIL 1 at bedtime or twice daily as needed. Discussed stretching and strengthening exercises.									N	10/13/2008	10/13/2008	0	None	PVT	PVT	BONIVA, DYAZIDE, NEXUIM, CALCIUM, SIMVASTATIN,  PRILOSEC, ALLEGRA, CYMBALTA - Hypercholesterolemia, SYNTHROID - Osteoporosis	follow up hypercholesterolemia	Drug Allergy: BACTRIM; depression, hypothyradism, sleep apnea			1						2	Activities of daily living impaired; Immediate post-injection reaction; Injected limb mobility decreased; Injection site pain; Induration; Pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2757AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2757AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|TDAP~SANOFI PASTEUR~C2768BA~UNK~UN~LA~TDAP (ADACEL)~2	USA		Influenza
0330701	10/30/2008	UT	20.0	20		F	10/16/2008	Ct was given a TDAP by accident. Ct is pregnant. Ct is HIV positive.									Y	10/15/2008				PUB	PUB	Unknown		HIV positive			1						1	Drug exposure during pregnancy	FLU3~SANOFI PASTEUR~U2802AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2768BA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0330702	10/30/2008	MT	16.0	16		F	10/27/2008	Fainted after GARDASIL #1 within 5 min of admin - then moved from chair to bed without problems. Recovered within 20 min - no further problems reported.									Y	10/22/2008	10/22/2008	0		PUB	PUB		None reported	None reported	10/22/2008~HPV (no brand name)~1~15.00~In Sibling		1						1	Syncope	FLU3~SANOFI PASTEUR~U2806AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0072X~1~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0330703	10/30/2008	MT	15.0	15		F	10/27/2008	Nearly fainted after GARDASIL #1 (After watching sister faint). Recovered within 10 min of laying down - Did not lose consciousness.									Y	10/22/2008	10/22/2008	0		PUB	PUB		None reported	None reported	10/22/2008~HPV (Gardasil)~1~16.00~In Sibling		1						1	Presyncope	FLU3~SANOFI PASTEUR~U2806AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0072X~1~IM~RA~HPV (GARDASIL)~1	USA		Influenza
0330704	10/30/2008	PA	47.0	47		M	10/13/2008	Fatigue and sore injection site evening of Day #1 also sweats at night, Days #2-4 continued fatigue, mild malaise. Days 4-6 worsening URI and mild flu-like symptoms the worst being coughing especially at night Day #7, symptoms appear to be improving. No fever, no aches, self-started Rx with Azithromycin pack on Day #5 as well as cough suppressants and expectorant (OTC DELSYM, NYQUIL).									U	10/06/2008	10/06/2008	0		PVT	PVT						1						1	Cough; Fatigue; Influenza like illness; Injection site pain; Malaise; Night sweats; Upper respiratory tract infection	FLUX~UNKNOWN MANUFACTURER~AFLLA185AA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330705	10/30/2008	PA	31.0	31		M	10/13/2008	10/12/08 - Symptoms of fatigue, tired, chills, fever (101.4), lasted approx. 6-8 hours.									Y	09/29/2008	10/12/2008	13		PVT	PVT			Seasonal allergies			1						1	Chills; Fatigue; Pyrexia	FLUX~UNKNOWN MANUFACTURER~AFLLA185AA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330706	10/30/2008	PA	21.0	21		F	10/13/2008	Lasting 6+ days! Horrible flu-like symptoms: High fever, chills, sweating, headache, fatigue, aching body, nausea, very painful sore throat, runny nose, cough that inhibited sleep. NYQUIL, MOTRIN, and DELSYM cough - Nothing helped - greatly.									N	10/06/2008	10/07/2008	1		PVT	PVT	ACCOLATE; LOESTRIN; MAXAIR; Multi vit.;	None	Allergies: Latex, shellfish, peanuts, cherries; Asthma; Anemia, borderline			1						1	Chills; Cough; Fatigue; Headache; Hyperhidrosis; Influenza like illness; Insomnia; Nausea; Oropharyngeal pain; Pain; Pyrexia; Rhinorrhoea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA185AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0330707	10/30/2008	PA	52.0	52		F	10/09/2008	Severe chills, headache, fatigue, cough. MOTRIN, TYLENOL, ROBITUSSIN.									Y	10/06/2008	10/06/2008	0		PVT	PVT	Over the counters supplements only	None	high cholesterol			1						1	Chills; Cough; Fatigue; Headache	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA185AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0330708	10/30/2008	MO	38.0	38		F	10/27/2008	Client stated she had fever, chills, and muscle aches for 3 days after shot. Continues to have limited mobility to (L) arm 11 days after shot.									U	10/16/2008				PUB	PUB						1						1	Chills; Injected limb mobility decreased; Myalgia; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA167AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330709	10/30/2008	LA	7.5	7		M	10/27/2008	10/23/08 pt saw school nurse for redness, soreness and warmth noted at vaccination site - Parent called Ped clinic 10/24/08 b/c site redness spreading Dr. saw site. RXN to flu shot given 10/22/08 ( BENADRYL ).				Y					Y	10/22/2008	10/23/2008	1		PVT	OTH		None				1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U2759AA~3~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1140X~2~UN~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0330710	10/30/2008	PA	65.0	65		F	10/27/2008	Pain in arm started 10/7/08. When reaching for anything or moving left arm she feels pain. Taking ADVIL for pain but not helping. Using ice also not helping.				Y					N	10/07/2008	10/07/2008	0	Nothing yet - Dr appt Wed 10/29/08	OTH	PVT	None	None	ACCUPRIL allergy			1						1	Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0330714	10/30/2008	MI	14.0	14		M	10/29/2008	Child was given vaccine, two hours later complained of chills, child complained of numbness to both feet and hands, child dizzy and lightheaded, took next day to Ped Ped felt reaction to vaccine child also with 4 bouts of diarrhea. Numbness to leg/feet 2 days then gone.				Y					Y	10/26/2008	10/26/2008	0		PUB	PUB	None	None	None			1						1	Chills; Diarrhoea; Dizziness; Hypoaesthesia; Injection site reaction	FLU3~SANOFI PASTEUR~U2839AA~5~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330715	10/30/2008	OH	48.0	48		F	10/30/2008	Temp 101.2, vomitings, difficulty breathings, lung congestion, cough, sore throat. Thur - flu shot. Fri - pneumonia vac - Sat temp 101.2.				Y					N	10/10/2008	10/11/2008	1	Blood work	PUB	OTH	REQUIP; PROTONIX; LASIX		None			1						1	Blood test; Cough; Dyspnoea; Oropharyngeal pain; Pulmonary congestion; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2771AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0330718	10/30/2008	KY	65.8	65		M	10/30/2008	Within two hours, upset stomach, extended diarrhea that last for two days.									N	10/26/2008	10/26/2008	0	None	OTH	PVT		Diarrhea				1						1	Diarrhoea; Stomach discomfort	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330719	10/30/2008	IL	25.0	25		F	10/27/2008	Fever of 102 degrees F with shaking chills and sweats started approx 12 hours after receiving flu shot; sore throat, cough, and headache started approx 24 hrs after flu shot - symptoms began to improve after 3 hours.									Y	10/22/2008	10/22/2008	0		OTH	PVT		None				1						1	Chills; Cough; Headache; Hyperhidrosis; Oropharyngeal pain; Pyrexia; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA350CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330720	10/30/2008	NY	56.0	55		F	10/29/2008	Pain, increased warmth, hives (L) shoulder 24 hours after injection in (L) upper arm. Suspect localized allergic Rx but covered with KEFLEX for possible injection and OTC BENADRYL.									N	10/27/2008	10/28/2008	1		PVT	PVT						1						1	Hypersensitivity; Pain; Skin warm; Urticaria	FLU3~SANOFI PASTEUR~1383U~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~U2754AA~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330723	10/30/2008	TX	49.0	49		M	10/30/2008	Patient was awakened by swelling of tongue and throat, swelling and pain in testicular area.									Y	10/29/2008	10/30/2008	1		OTH	PVT						1						1	Pharyngeal oedema; Swollen tongue; Testicular pain; Testicular swelling	FLU3~SANOFI PASTEUR~1132U~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~U2757AA~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330728	10/30/2008	NY	3.0	3		F	10/30/2008	Fever, seizure. Administered: 10-28-08 1539. Symptoms: 10-29-08 after school. 11/12/2008 MR received for DOS 10/29-30/08 with DX:  Pneumonia, Fever, Possible seizure vs syncope. Pt presented after an episode of limpness and unresponsiveness where pt's eyes rolled up x several minutes. Vomited after. Post-ictal in ambulance. Temp 102'F in ER. Neuro consult Impression: Possible seizure vs vasosvagal event.  No signs of increased ICP. Tx with abx. Will get EEG as outpt.					Y	1				10/28/2008	10/29/2008	1	Known case of macrocephaly asymptomatic, stable, seeing neurologist, last visit 7-24-08 whose follow-up MRI somewhat improved; on speech therapy, PT, OT . Labs and Diagnostics:  EKG WNL. CT brain scan abnormal. CBC with WBCs 17.0.  CXR (+) for LLL pneumonia.	PUB	PUB		None	Known case of macrocephaly w/ bilateral frontal subdural . PMH: Develpmental Delay, Hydrocephaly			1						1	Convulsion; Nuclear magnetic resonance imaging; Pyrexia; Speech rehabilitation	FLU3~SANOFI PASTEUR~U2797CA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0330729	10/30/2008	CT	0.54	0	.5	M	10/29/2008	Pt was being fed lunch, seemed fussy. Approx 30 minutes later developed twitching of one leg then the other. Pt brought to office after dad noted full body twitching and deviating eyes. The patient is a 6 month old male who was present with a complaint of seizures notes: patient brought into office by father at 1:13pm. While feeding him carrots at lunch patient did not seem to like them. He cried a little. Dad stopped feeding him and gave him a bottle instead. Approximately 1/2 hours later he started twitching. First it was one leg, then the other and then it was his arms. He called our office and a sick visit was made. Patient then progressed to his entire body twitching and eyes devlating. Dad put patient in the car and drove him to our office. Denies cyanosis or apnea. No hx trauma or choking. No fever. No URI sx. He received DTap, IPV, Prevnar, Flu, Hib and Rotavirus vaccines yesterday. Pt was in status upon arrival to our office. He was having a generalized tonicclonic seizure with eye deviation to the right. No cyanosis. Oxygen was applied immediately and 911 was called. Temp 100.9 Temporal, Pox 92%-99%, HR 140-160, RR 32-40. Accucheck 86. Pt given rectal Valium by EMS at 1:26pm. Pt developed perioral cyanosis, no apnea. PPV applied for approx 3 minutes and then free flow oxygen was used. IV attempted x 1. There was no change in seizure status. Pt place on stretcher and transported to the ER. Rectal Valium was given again prior to leaving the office (?time of administration). ER and Hospitalist were notified.  02/23/2009 MR received for 1/23-24/2009 with DX: Status epilepticus vs complicated febrile seizure. Pt initially presented to PCP in status epilepticus where EMS was called and transported. Temp 100.9 in office. Rectal Diastat x 2.  Seizing ~1hr with lip cyanosis. Seizure resolved on arrival. Temp 101.4. Pt in sinus tach.  PE (+) for being initially unresponsive to touch, later sleepy with decreased tone.					Y	2			Y	10/22/2008	10/23/2008	1	Chest x-ray negative. Labs and Diagnostics:  Head CT (-).  CXR (-). LP with WNL. CSF cx (-). CBC WNL. Bicarb 19.  anion gap 11. UA (+) for trace ketones, small blood. AST 61. Alk Phos 299. Viral and bacterial testing all (-).	PVT	PVT	Prevacid	NONE	Esophageal Reflux and acute bronchiolitis due to other infectious organisms PMH:  Premie twin. Fam hx of epilepsy			1						1	Body temperature increased; Chest X-ray normal; Convulsion; Cyanosis; Gaze palsy; Grand mal convulsion; Irritability; Muscle twitching; Respiratory rate increased; Status epilepticus	DTAP~SANOFI PASTEUR~C2992BA~3~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2787CA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF492AA~3~IM~LL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~A0805~3~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~C86139~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1887U~3~UN~UN~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0330743	10/30/2008	MI	0.75	0	.8	F	10/30/2008	10/28/08 Mother states rash all over body, whiny and not sleeping x 1 week. 10/28/2008 rapid strep culture neg. 10/30/2008 throat culture obtained 10/28/2008 reported moderate normal flora.				Y					Y	10/23/2008			10/28/2008 neg. rapid strep neg.  10/30/08 throat culture obtained 10/28/2008 reported moderate normal flora.	PVT	PUB	NONE	None.	reactive airway			1						1	Culture throat negative; Irritability; Rash generalised; Sleep disorder; Streptococcal identification test	FLU3~SANOFI PASTEUR~UT27887A~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB517AA~3~IM~LL~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0330744	10/30/2008	NC	49.0	49		F	10/30/2008	15 minutes following the injection, client complained of tingiling lips and feeling fainty. Client placed in recumbent position. B/P 108/70. Benadryl 25 mgm per os given. 20 minutes following Benadryl administration, client confirmed decrease in feeling fainty and decreased tingiling of lips.									Y	10/29/2008	10/29/2008	0		PUB	PUB						1						1	Dizziness; Paraesthesia oral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA172AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330745	10/30/2008	IL	63.0	64		M	10/30/2008	Roughly 8 hours later after recieveing the flu vac. Patient stated that he was ill.  Nausea, vomiting, shaking, fever.									Y	10/08/2008	10/08/2008	0	none	PVT	UNK	Sensipar,Aranesp, Renagel,Cellcept, Cytonvene, Dialyvite, Rocaltrol, Synthroid, Aspirin, Diovan, Rapamune, Norvasc	None	Kidney Dialysis Patient			1						1	Malaise; Nausea; Pyrexia; Tremor; Vomiting	FLU3~SANOFI PASTEUR~U2789BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330746	10/30/2008	IL	56.0	56		M	10/30/2008	Approximately 2 hours after receiving vaccine, I experienced an episode of dizziness, to the point that I needed to sit down to avoid falling.  After sitting for about 15-20 minutes I was able to get up and walk back to my office.  For the next few hours though, I continued to feel a little disoriented or loopy for the lack of a better word. Went home about 4 hours later and seemed to be fine, just a little more tired than usual.  Doing just fine now.  PS. I am employed at a hospital and received the vaccine as part of being a healthcare worker.									Y	10/28/2008	10/28/2008	0	None.	UNK	UNK	None.	None.	None.	None~ ()~~0.00~In Patient		1						1	Disorientation; Dizziness; Fatigue	FLUX~UNKNOWN MANUFACTURER~unknown~5~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330747	10/30/2008	AR	25.0	25		F	10/30/2008	area of 3x6 cm erythema and induration at site present tow days after injection.  Afebril to apply local compress and take NSAIDs.									Y	10/28/2008	10/30/2008	2		PUB	PUB						1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~u2807aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330749	10/30/2008	PA	32.0	32		F	10/30/2008	Patient received Pneumovax vaccine on Friday, Oct 17, 2008 at approximately 4:00 pm in her right arm. The pt insisted on receiving the vaccine.  On Sat, Oct 18, the patient presented to the emergency room with symptoms of generalized body aches and a 9x9 erythematous area in the right deltoid muscle area.  The redness stretched from the pt's shoulder to her elbow.  The cellulitis-type rash was swollen, red-hot, and tender to the touch.  The pt was started on cephalexin and Bactrim for treatment of cellulitis.				Y					Y	10/17/2008	10/18/2008	1		PVT	UNK	Unknown	Patient is listed as having chronic fatigue syndrome, chronic autoimmune disorder, and multiple chemical sensitivities.	NKDA	Unknown~ ()~NULL~~In Patient|Unknown~ ()~NULL~~In Sibling1|Unknown~ ()~NULL~~In Sibling2		1						1	Cellulitis; Erythema; Oedema peripheral; Pain; Rash erythematous; Skin warm; Tenderness	FLU3~CSL LIMITED~01349111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~0397X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0330751	10/30/2008	MN	71.0	71		M	10/30/2008	I RECEIVED THE VACCINATION AT 3:00PM. AT 8:00PM I BEGIN TO FEEL FUNNY. AT 9:00PM I STARTED TO GET SEVERE CHILLS AND A VERY SEVERE HEADACHE. IT PROGRESSIVELY GOT WORSE SO I WENT TO BED COVERING WITH MANY COVERS, FINALLY WAS ABLE TO STOP SHAKING AROUND 1:00AM.  FROM 1:00AM TO 5:00AM I EXPERIENCED, RAPID HEARTBEAT, SHALLOW BREATHING AND JUST ABOUT THE WORST PRESSURE HEADACHE I HAVE EVER EXPERIENCED. I WAS FINALLY ABLE TO FALL ASLEEP AT THAT TIME AND AWOKE AT 9:00AM FEELING MUCH BETTER. SPENT THE DAY IN BED AS I FELT EXHAUSTED! THE NEXT DAY I FELT PRETTY GOOD.									Y	10/17/2008	10/17/2008	0		UNK	UNK						1						1	Chills; Fatigue; Feeling abnormal; Headache; Heart rate increased; Hypoventilation; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330752	10/30/2008	KY	33.0	33		F	10/30/2008	Approx 30 minutes after receiveing the vaccine, the patient developed intense itching, hives and sensation of throat swelling. Received Benadryl IM initially, required a repeat dose which was given Intravenously. No subsequent episodes of symptoms after that time.  Follow-up: Pt hospitalized at time of vaccination but reaction so severe that would have required hospitalization any way.							Y		Y	10/23/2008	10/23/2008	0		UNK	UNK	Lovenox, Procardia, Colace, Multivitamin	Hospitalized for Preterm Labor (30 weeks gestation)	Sulfa allergy			1						1	Pharyngeal oedema; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2791BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0330753	10/30/2008	MN	43.0	43		F	10/30/2008	erythematous edematous hive type rash on left arm									Y	10/29/2008	10/30/2008	1	none	PUB	UNK	none	none	none			1						1	Erythema; Rash erythematous; Urticaria	FLUX~UNKNOWN MANUFACTURER~u2766a~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330754	10/30/2008	IL	55.0	55		M	10/30/2008	Tachycardia, pounding of heart									Y	10/29/2008	10/29/2008	0	none	PVT	PVT	Lisinopril (40mg); Welchol (3 x 625 mg); Metformin (1000 mg twice per day); Nifedipin (60 mg)	slight sinus congestion	hypertension, diabetes			1						1	Palpitations; Tachycardia	FLU3~CSL LIMITED~AFLUA357BA~3~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0330755	10/30/2008	TX	84.0	84		F	10/30/2008	2 DAYS POST SHOT PATIENT DEVELOPED TONGUE SWELLING, SWOLLEN LYMPH NODES AND WELTS ON THE BACK OF TONGUE THAT CAUSED PAIN IN THE MOUTH									U	10/27/2008	10/29/2008	2	HOSPICE NURSE EVALUATED PATIENT AT HER HOME	UNK	UNK	UNKNOWN	CHF AND ON HOSPICE PER PATIENT'S DAUGHTER	UNKNOWN			1						1	Lymphadenopathy; Oral pain; Swollen tongue; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88636~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330756	10/30/2008	IA	23.0	23		F	10/30/2008	Patient reported that approximately one hour after receiving the Flu Mist that her face became very red and flushed. She had no itching, no facial edema, no SOB, no other s/s at all.  She reports that this lasted approximately one hour and then disappeared.  She also reports that she is taking Accutane and wonders if there is some reaction with this medication and Flu Mist.									Y	10/21/2008	10/21/2008	0	None	UNK	PVT	Accutane	None	unknown			1						1	Erythema; Flushing	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0330757	10/30/2008	IL	73.0	73		M	10/30/2008	For 3 days I had a fever and my bones felt like they were on fire and hurt                         Moltrin									Y	09/15/2008	09/16/2008	1		PVT	UNK		None				1						1	Bone pain; Burning sensation; Pyrexia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330758	10/30/2008	IL	80.0	80		F	10/30/2008	Client noted reddness & swelling (about 4x5)at injection site mid-morning 10/26/08. No tenderness at site. Went to ER On 10/26/08 at 2pm. BP 198/71; Dx:Cellulitis & HTN. Client saw her primary care physician, on 10/27/08. Redness/swelling still remained.  Given Medrol dose pack. Client states redness/swelling gone by 10/29/08.				Y					Y	10/24/2008	10/26/2008	2	None	UNK	UNK	Unknown	None	HTN, pacemaker			1						1	Cellulitis; Hypertension; Injection site erythema; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA165AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0038U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0330760	10/30/2008	TX	66.0	66		M	10/30/2008	Patient received flu (lt) and pneumonia (rt) vaccinations 10/23/08 at VA, and within 24 hrs had swelling of right arm and pain at injection site.  VS wnl.  Moderate edema and redness rt f/a; no pain or tenderness c/o.  MD recommended patient use diphenhydramine as needed.									Y	10/23/2008	10/24/2008	1	C-REACTIVE PROTEIN        1.38 H   mg/dL WESTERGREN                  43 H   MM/HR	MIL	PUB	ASPIRIN 325MG TAB         BUPROPION HCL 150MG 12HR SA       CARVEDILOL 12.5MG TAB  CLOPIDOGREL BISULFATE 75MG TAB   DOCUSATE NA 100MG CAP  FERROUS GLUCONATE 325MG  FOLIC ACID 1MG TAB  LISINOPRIL 40MG TAB  METHOTREXATE NA  2.5MG TAB	none	HF (ICD-9-CM 428.0) CAD (ICD-9-CM 414.9) Elevated Prostate Specific antigen [psa] Anemia (Osteoarthrosis involving the spine Ankylosing Spondylitis Hyperlipidemia HTN COPD			1						1	C-reactive protein increased; Erythema; Injection site pain; Injection site swelling; Oedema peripheral; Red blood cell sedimentation rate increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~892972P~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0979X~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330761	10/30/2008	NY	73.0	73		F	10/30/2008	Soreness to right deltoid, injection site of pneumovax vaccination. Mild nausea starting 6pm of 10/28/08. Chills starting 4pm 10/29/08. 8:45am 10/30/08 only injection site soreness remains.									Y	10/28/2008	10/28/2008	0	n/a	PUB	PVT	Vitamins	none	PCN			1						1	Chills; Injection site pain; Nausea	FLU3~SANOFI PASTEUR~U2742AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~U804U~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330762	10/30/2008	WI	52.0	52		F	10/30/2008	Patient presented 2 days after vaccine was given with new onset of symptoms that began yesterday.  They included swelling and puritis around both eyes, slight edema of lower lip, and a flat puretic rash on her neck.  She denies any c/o sob.  She was instructed to begin Claritin now and then tonight at bedtime to take 25mg of bendryl.  She was instruced to go directly to the ER if any difficulty in breathing occurs.  She did not identify any risk factors prior to the vaccine and she has had the flu vaccine in the past and did not have any problems.									U	10/28/2008	10/29/2008	1	none	UNK	PVT	none	None	none			1						1	Eye pruritus; Eye swelling; Lip oedema; Rash macular; Rash pruritic	FLU3~SANOFI PASTEUR~U2806AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330763	10/30/2008	MA	52.0	52		F	10/30/2008	Pt received the flu shot and pneumococcal vaccine in the left deltoid and had a cellulitis within 24 hours.  Alcohol was used to prep the skin.  Bandaids were applied.  Pt's PMH pertinent for long time smoker, copd				Y					U	10/29/2008	10/30/2008	1		PVT	PUB		NO	COPD,  skin rash on the other shoulder			1						1	Cellulitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89683~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0870X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0330765	10/30/2008	VA	55.0	55		M	10/30/2008	CHEST PAINS STARTED WITHIN 18 HOURS ER ADMISSION 24 HOURS AFTER ADMINISTRTION DX WITH INFLAMMATORY REACTION TO FLU SHOT				Y					Y	10/28/2008	10/29/2008	1		PVT	PVT	UNKNOWN	NO	UNKNOWN			1						1	Chest pain; Inflammation; Vaccination complication	FLU3~SANOFI PASTEUR~U2795BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330768	10/30/2008	VA	53.0	53		F	10/30/2008	c/o redness and induration at site of immunization - developed about 12 hrs after vaccine  Arm red, about 3  X 3 induration and redness over deltoid area LASTED 48 HRS									Y	10/14/2008	10/14/2008	0		PVT	PVT	UNKNOWN	NONE	UNKNOWN			1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U2795BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330769	10/30/2008	NC	61.0	61		F	10/30/2008	I received my flu injection @ 10:10 AM. @ 11:00 AM I started having my symptoms.Itching all over my body(soles of feet,palms,back,head ect.), bright red skin color, problem focusing my vision, eyes & lips swelling,uncontrollable shaking and severe indigestion.My breathing was normal. BP 115/70,O2 SAT 96%.I received 50 mg. of benedryl IM @ 11:15AM.I was transferred to the ER(BP 90/59 SAT 96%) and treated with IV steroids,benedryl and meds for my indigestion. I began feeling better and was d/c'd home @ 15:00.Home medications were prednisone 20mg po x 4 days,benedryl and pepcid AC x3 days. I woke up with severe pain & slight weakness in both legs on 10/11. My medical physician on 10/13 stated it was probably inflammation I had normally and the steroids made me feel better. When I stopped the steroids (it was not a tapered dose)the inflammation came back with force. I was treated w/Advil for seven days. I have had no more problems.				Y					Y	10/07/2008	10/07/2008	0	none	PUB	UNK	BP medication and baby aspirin	none. I have taken the flu vaccine every year it has been offered. This was the first time I had a reaction.	medication allergy:Statins-severe muscle cramps. Niacin-severe buring sensation all over my body. medical HX of hypertention-treated w/my medication			1						1	Dyspepsia; Erythema; Inflammation; Lip swelling; Muscular weakness; Oxygen saturation normal; Pain in extremity; Pruritus generalised; Tremor; Vision blurred	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0330771	10/30/2008	TX	48.0	48		M	10/30/2008	Recieved vaccine @ right DELTOID (arm) after 7 hrs noted blue eccymoised area distial to site on inner aspect of upper arm 3x3 inches wide									Y	10/27/2008	10/27/2008	0	NONE REQ	MIL	MIL	LOTREL    LIPITOR		HTN			1						1	Injection site discolouration; Injection site haemorrhage	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197AA~4~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0330773	10/30/2008	VA	28.0	28		F	10/30/2008	red and warm area at injection site within 24 hrs. area continues to ache with sharp pinches down arm 2 weeks after									U	10/14/2008	10/15/2008	1		PVT	PVT	unknown	none reported	unknown			1						1	Injection site erythema; Injection site pain; Injection site warmth; Pain in extremity	FLU3~SANOFI PASTEUR~U2795BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330774	10/30/2008	NE	51.0	51		F	10/30/2008	Received injection at approximately 1330on 10/27/08, 3-4 hours later noticed sore L) arm.  At 2100 10/27/08, noted sore trapezium muscle and fatigue. Woke up on 10/28/08, noted to have enlarged and painful L) supraclavicular lymph node.  10/30/08 1345 came to Employee Health clinic after beling told by clinic doctor to go to employee health and have them report reaction.  Patient stated that suprclavicular lymph node is larger today than it was on 10/28 and with increase pain.									N	10/27/2008	10/27/2008	0		UNK	UNK	Premarin  Toprol XL	None	Hypertension			1						1	Fatigue; Lymph node pain; Lymphadenopathy; Myalgia; Pain in extremity	FLU3~CSL LIMITED~01349111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0330775	10/30/2008	ME	54.0	54		F	10/30/2008	Patient reports arm pain when lifting since influenza vaccine on 10/15/08.  No treatment. Advised patient to call MD and report sx.									U	10/15/2008	10/15/2008	0		PUB	PVT						1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2751AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330776	10/30/2008	SC	18.0	18		F	10/30/2008	4:03PM, about 3 minutes after vaccine was administered, the patient complained of numbness in the left arm.  4:15 PM BP 110/60, P 88, R 16.  Tearful.  No itching or respiratory distress.  4:25PM, vital signs unchanged, numbness decreased.  Left clinic site with instructions to return to Health Services as needed.  10/30/08-patient called by Health services staff and reports she is fine.									Y	10/29/2008	10/29/2008	0		UNK	PUB				swelling/redness at site~Td Adsorbed (no brand name)~UN~~In Patient		1						1	Crying; Hypoaesthesia	FLU3~SANOFI PASTEUR~U2793DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330778	10/30/2008	AZ	10.0	10		F	10/30/2008	Redness of left 3.0 cm x 6.5 cm, warm to touch at injection site of either Tdap or flu vaccine given to left deltiod on Monday immunization clinic.  Contacted/reported to Dr. (LM). Instructed parents to take benadryl and to apply cortisone cream to the site.									U	10/20/2008	10/21/2008	1		UNK	UNK		none			AZ0818	1						1	Injection site warmth	FLU3~SANOFI PASTEUR~U2808AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHAVB436AA~UNK~IM~RA~HEP B (ENGERIX-B)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~ACE2B029AA~1~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0330779	10/30/2008	MO	38.0	38		F	10/30/2008	Severe itching, chest heaviness, cough beginning 15 min after shot and lasting for 24 hours. Saw Dr. and treated with loratadine then Benadryl and albuterol inhaler.  No lab work or CRX done.   Pt had VAERS1 a year earlier - blamed on MMR.  She had + ANA 1:640 speckled/homogenous.  Repeat pending.				Y					Y	10/07/2008	10/07/2008	0	RF negative.  ESR 17. CBC normal. (ANA titer pending)	MIL	MIL	Multivitamin. Reglan.	chronic joint pain	cats, ragweed	rash, joint pain, severe itch, SOB~Measles + Mumps + Rubella (MMR II)~1~36.60~Patient		1						1	Chest discomfort; Cough; Full blood count normal; Pruritus; Red blood cell sedimentation rate normal; Rheumatoid factor negative	FLU3~SANOFI PASTEUR~U2793FA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330780	10/30/2008	IA	47.0	47		F	10/30/2008	Patient's right arm was sore after flu shot. No rash or swelling noted by patient. Patient developed aches and pains which start around the arm and radiate into her back, neck, hips, and other arm.									U	10/15/2008	10/16/2008	1		UNK	PVT	Lithium	Unknown	Manic Depressive			1						1	Arthralgia; Back pain; Neck pain; Pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2747AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330782	10/30/2008	NE	46.0	46		F	10/30/2008	Had the flu vaccine at 0800 10-30-2008 and approximately 1 1/2 hours after receiving the vaccine pt reported continuous dry cough then rhinitis, red watery eyes, sore itchy throat, slight shortness of breath and soreness in throat with breathing and especially with coughing returned to clinic, CBC w/diff was drawn, saline lock started and 1000cc Normal Saline bolus, also given was Benadryl 25mg IVP, Decadron 4mg IVP and Solumedrol 80mg IVP Lab results showed Patient improved with treatment and was dc'd to home in stable condition.				Y					Y	10/30/2008	10/30/2008	0	CBC w/ diff WBC, 15.9 k/uL, Neutrophil 85%, Bands 5%, Lymphs 9%, Monocytes 1%, Eosinophil 0%, Basophil 0%	UNK	UNK	Micardis HCT 40/12.5 daily	none	HTN	2006 and 2007 developed cough soon after receiving influenza vaccine also can't remember time frame lasted most of winter, doesn		1						1	Band neutrophil percentage; Cough; Dyspnoea; Full blood count; Lacrimation increased; Lymphocyte percentage decreased; Monocyte percentage; Neutrophil percentage increased; Ocular hyperaemia; Oropharyngeal pain; Rhinitis; Throat irritation; White blood cell count increased	FLU3~SANOFI PASTEUR~U2769AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330783	10/30/2008	CA	35.0	35		F	10/30/2008	I had my first flu shot ever this morning at ~10am and as of about 1pm I developed a mild cough reminiscent of ORS. I was confused at first because none of the flu shot symptoms I read about mentioned coughing (other than for the inhalant form of the vaccine). I did more research and discovered ORS, which I'm pretty sure this is (symptoms are not worsening, nor have any new symptoms arisen). Not even the advice nurse knew what ORS was. Other than the mild cough, I feel fine and will not be seeking treatment from a doctor.									Y	10/30/2008	10/30/2008	0		UNK	UNK	Trivora 28	None	None			1						1	Cough	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330784	10/30/2008	CO	61.0	61		F	10/30/2008	Hard, painful swelling above elbow on posterior, lateral, upper arm.  Applicatin of heat seemed to help.  Claims she was in bed for 5 days and could not move her arm.  Patient did not seek treatment.									Y	10/22/2008	10/23/2008	1	n/a	UNK	PVT	Tretinoin 0.025%crm, Zolpidem 10mg tab	none				1						1	Activities of daily living impaired; Induration; Injected limb mobility decreased; Oedema peripheral; Pain in extremity; Erythema; Fatigue; Headache; Hypokinesia; Induration; Oedema peripheral; Pain; Pain in extremity; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89971~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0061U~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~66521011110~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~00006473900~UNK~UN~UN~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0330785	10/30/2008	UT	26.0	26		M	10/30/2008	He describes pain in Left anterior axillary fold, and some tingling down into the elbow. There was no erythema, induration, increased warmth, swelling, or other injection site reactions. There were no motor or sensory deficits in L arm or shoulder. There was no epitrochlear, supraclavicular, or axillary adenopathy.										10/28/2008	10/29/2008	1	none	PVT	PVT	none	none	none			1						1	Axillary pain; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua381ba~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330786	10/30/2008	SD	9.0	9		F	10/30/2008	Immediately after receipt of intramuscular influenza vaccine, child fainted--eyes closed, head rolled to side, arms flacid--while still sitting in chair. Assisted child to floor whence she immediately regained consciousness with orientation to person, place, event. Allowed to lie still for 1 minute. Assisted to a chair, observed for 15 minutes with no further issues. Accompanied to classroom by school nurse.									Y	10/28/2008	10/28/2008	0	none	UNK	UNK	none	Complained of sore throat, no medical attention, attended school.	Seizures at 1-2 years of age, EEG diagnosed mini mal seizures. No medication, parent advised by MD that child would grow out of seizures. History of 1-2 episodes annually.			1						1	Hypotonia; Posture abnormal; Syncope	FLU3~SANOFI PASTEUR~U2760AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330787	10/30/2008	FL	37.0	37		F	10/30/2008	Apporoximately 70 hours after vaccine administration, patient developed fever, joint pain and tightening of the throat that persisted for roughly 12 hours. No permanent injury occured due to the tightening of the throat. No treatment of the symptoms was performed by the patient. Patient subsequently had general malaise for 72 hours. Patient did not follow-up for evaluation or treatment during the symptoms and did not treat self for the symptoms. The symptoms resolved on their own.									Y	10/18/2008	10/21/2008	3	N/A	PVT	PVT	None.	None.	Allergies; Shrimp (N/V, loss of consciousness), grapefruit(migranes. Medical conditions; interstitial cystitis.			1						1	Arthralgia; Malaise; Pyrexia; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0330789	10/30/2008	OR	66.0	66		M	10/30/2008	Nerve tingling on one side (right) around eye and down the neck									Y	10/05/2007	10/06/2007	1	none	UNK	PVT	not known	none reported	I believe he had a prior history (10years) of shingles.  His doctor wanted him to receive the vaccine.			1						1	Paraesthesia	FLU3~SANOFI PASTEUR~u2493aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~0356u~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0330793	10/30/2008	UT	68.0	68		M	10/30/2008	This case was reported by a pharmacist and described the occurrence of elevated white blood cell count in a 68-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included Crohn's disease. Concurrent medications included MESALAMINE, loratadine, omeprazole, prednisone, terazosin, clonazepam, gabapentin, multivitamin, simethicone, propranolol and loperamide. On 16 October 2008 the subject received a dose of FLULAVAL at 0.5 ml. On 16 October 2008, less than one day after vaccination with FLULAVAL, the subject experienced elevated white blood cell count and fever. The subject was already hospitalized and ready to be discharged when the flu vaccine was administered. The subject's hospital stay was extended because of the fever and elevated white blood cell count. The pharmacist considered the events were disabling, life threatening and clinically significant (or requiring intervention). The subject was treated with antibiotic. At the time of reporting the subject's elevated white blood cell count was improved and the fever was resolved. In the reporter's opinion, the elevated white blood cell count was probably related to treatment with FLULAVAL. The relationship of the fever to FLULAVAL was unknown. The reporting pharmacist did state that in hindsight, they probably should have not started the antibiotic therapy and his extended stay could be related to that and not the actual flu vaccine.			Y		Y			Y	N	10/16/2008	10/16/2008	0	UNK	MIL	OTH	mesalazine; loratadine; omeprazole; prednisone; terazosin; clonazepam; gabapentin; multivitamin; risperidone; trazodone; lact. acid-producing orgs; simethicone; propranolol hydrochloride; loperamide hydrochloride	Crohn's disease	The subject has previously received flu shots and the reporter was not aware of any reactions to these flu shots or any adverse events following previous vaccinations.		A0754181A	1						1	Pyrexia; White blood cell count increased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~LL~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0330804	10/30/2008	CA	48.0	48		F	10/30/2008	Pt seen in the ED with eye swelling, difficulty talking, non-radiating chest pressure treated with BENADRYL 25mg po. 10/15/08.				Y					Y	10/14/2008	10/15/2008	1		PVT	PVT		None	allergic to AUGMENTIN; HTN			1						1	Chest discomfort; Eye swelling; Speech disorder	FLU3~SANOFI PASTEUR~U2831AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330806	10/30/2008	CA	1.3	1	.3	F	10/30/2008	Per Mom - Patient has rash all over body. Booked her an appointment with Dr. to be seen on 10.30.08. Dx believes rash is not due to vaccines.									U	10/29/2008	10/30/2008	1		PVT	PVT		None	None			1						1	Rash generalised	FLU3~SANOFI PASTEUR~UT2783FB~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB238AA~1~IM~LL~HEP A (HAVRIX)~1	USA		Influenza
0330807	10/30/2008	MO	5.0	5		M	10/30/2008	None stated.				Y					Y	10/24/2008	10/25/2008	1		PVT	PVT	OTC cold meds.	Cold symptoms and loose stools	PCN - rash 12/28/04			1						1	No adverse event	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B087BA~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2798EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1137X~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0330808	10/30/2008	MI	66.0	66		M	10/30/2008	Fever 100-102 degrees, chills, aches.									U	10/28/2008	10/29/2008	1	Currently feels ill	OTH	OTH						1						1	Chills; Malaise; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330809	10/30/2008	NY	1.3	1	.3	M	10/30/2008	Mom states pt cried non-stop for 5 hours after receiving 15 month shots. Child was not ill @ the time. Child woke from sound sleep and cried for 5 hrs. Fell back asleep - woke up fine. Mom also states this happened after 2 month shots 9/20/07 but never reported to physician.									Y	10/29/2008	10/29/2008	0	None	PVT	PVT		None	None	Crying > 5 hours~DTaP + HepB + IPV (Pediarix)~0~0.20~In Patient		1						1	Crying; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~UT2787DA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF496AB2110~4~IM~LA~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~1208X~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1241X~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0330810	10/30/2008	CA	31.0	31		F	10/30/2008	Within 30 minutes of vaccine, injection site began itching, swelling. Erythema of 8 cm. with minimal induration at actual injection site.									Y	10/30/2008	10/30/2008	0	None	PUB	PUB	None	Allergies only	None			1						1	Erythema; Injection site induration; Injection site pruritus; Injection site swelling	FLU3~SANOFI PASTEUR~U2808AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330811	10/30/2008	CO	5.2	5		F	10/30/2008	Flu shot Tues, 10/28/08 - Wed. morning 10/29/08 (+) redness and tenderness at injection site. (+) pain, redness, and spreading tenseness into today. No facial abscess or fluctuant mass noted. Tenderness, (-) induration.									U	10/28/2008	10/29/2008	1	None	PVT	OTH		None	None	Redness/tense @ inj. site.~Influenza (Seasonal) (no brand name)~UN~4.00~In Patient		1						1	Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U2758AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330812	10/30/2008	CA	14.0	14		F	10/30/2008	Myalgias. Fevers. Headache.				Y					N	10/24/2008	10/24/2008	0		PVT	PVT		Wart treated	Pectus excavatum; bee sting allergy			1						1	Headache; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U2757AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0575X~UNK~~~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0330813	10/30/2008	WA	63.0	63		F	10/30/2008	(1) Pain started from right shoulder on 10/28/08 evening, extended to right elbow joint and right finger joints, next day, and getting worse. (2) Wheezing for 2 days. (3) Local injection site is symptom free.				Y					U	10/27/2008	10/28/2008	1	No test, pt is given PDS x 6 days; V/S: all stable; SpO2 91%; Albuterol and BENDARYL, prn	PVT	OTH	Fluoxetine; Alendronate; Leflunomide	Rheumatoid arthritis	Allergies: Sulfa; Erythromycin; Codeine; Hydrocodone; Meperidine; RA; osteoporosis; depression; fibromyalgia	Wheezing.~Influenza (Seasonal) (no brand name)~UN~56.00~In Patient		1						1	Arthralgia; Musculoskeletal pain; Oxygen saturation decreased; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88907~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0330814	10/30/2008	WA	9.0	9		F	10/30/2008	Pt was given influenza vaccine x2 within the same day. Approximately 2 hrs apart.									U	10/29/2008	10/29/2008	0		PVT	PVT		None				1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~U2763AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330815	10/30/2008	NY	1.1	1	.1	F	10/30/2008	Rash developed 1/29/08 - slowly more lesions developed.									U	10/08/2008	01/29/2008			PVT	PVT	None					1						1	Rash; Skin lesion	FLU3~SANOFI PASTEUR~UT2782DA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C65045~4~IM~RA~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1142X~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0330816	10/30/2008	WI	67.0	67		F	10/29/2008	Swollen arm at site, headache, nausea (no vomiting) body aches, dizziness when arising, no laying down, red and hot, chills/sweating.									Y	10/27/2008	10/28/2008	1	Normal	PVT	OTH		None	asthma; hypothyroidism	1989 same symptoms as a bove.~Influenza (Seasonal) (no brand name)~UN~48.00~In Patient		1						1	Chills; Dizziness; Erythema; Feeling hot; Headache; Hyperhidrosis; Injection site swelling; Nausea; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA187AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~154IU~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330817	10/30/2008	MI	29.0	29		M	10/30/2008	Pt. received vaccine at 730 PM. He start throwing up in the morning. His face area swollen per his sister. Tried to call twice to get some more details and what medical help he received but did not get any answer. He got the flu shot 1st time.									U	10/27/2008	10/28/2008	1		OTH	OTH						1						1	Swelling face; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881132P~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330818	10/30/2008	FL	75.0	75		F	10/29/2008	All general symptoms attributed to flu - general malaise, nausea, fever and aches and pains beginning at 3 AM the night preceeding the vaccination. Lasted for 2 days with resolution on 3rd day.									Y	10/15/2008	06/16/2008			OTH	PVT		Systemic Lupus		~ ()~1~7.00~Patient		1						1	Malaise; Nausea; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332935	10/30/2008	VA	33.0	33		F	10/30/2008	Joint swelling and pain to left shoulder and upper arm									Y	10/14/2008	10/15/2008	1		PVT	PVT			unknown			1						2	Injection site pain; Muscular weakness; Arthralgia; Joint swelling; Musculoskeletal pain; Pain in extremity	FLU3~CSL LIMITED~02649111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|FLU3~SANOFI PASTEUR~u2795BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0329400	10/31/2008	AL	69.0	69		F		App. 4-5 hours after receiving injection, broke out in Hives went to emergency room.  Had shot and got prescription, on 10-22-08.  Went to family doctor.  More prescriptions med. given.				Y					N	10/17/2008	10/17/2008	0		PUB	UNK						1						3	Urticaria; Pruritus; Rash; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA364AA~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA364AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~2|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA364AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~3	USA	Emergency room visit	Influenza
0330792	10/31/2008	CA	81.0	81		M	10/31/2008	Vaccine given at 10:40 a.m. 10-29-08.  Headache in afternoon lasting until next day.  I never have headaches.  Tickle in throat during nap in afternoon.  Chills and fever at ll p.m bedtime.  Severe shivering until warmed by bed covers.  Achey that day and next day									Y	10/29/2008	10/29/2008	0		UNK	UNK						1						1	Chills; Headache; Pain; Pyrexia; Throat irritation	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330824	10/31/2008	IL	23.0	23		M	10/23/2008	Patient was admitted in hospital on Oct. 14, 2008.  He is still in the hospital.  The patient is a 23 year old male.  C/O seen over weekend for headache and fever, low grade SIQ then felt better, rashes 2 days ago, did not tell.  Today scattered more at face, body, scalp and arms plus sore throat and low grade fever today.  No abdomen pain, appetite down and cold and cough 3 days, no breathing problems.  ROS unchanged.  Problem list reviewed and medication list reviewed.  No generalized pain, energy level not specified, not feeling tired or poorly, and no lethargy.  Chills.  Watery nasal discharge.  No hoarseness.  Sore throat.  Skin lesion(s): No head symptoms.  No neck symptoms.  No cardiovascular symptoms.  No pulmonary symptoms.  Appetite not decreased.  No genitourinary symptoms.  No hematologic symptoms.  No musculoskeletal symptoms.  No dizziness, no confusion or disorientation, no focal disturbances, no motor disturbances, and good coordination.  No psychological symptoms.  11/03/2008 MR received for DOS 10/14-21/2008 with D/C Dx:  Varicella. Pt initially presented to clinic with c/o fatigue, H/A and feeling poorly-myalgias and arthragias and fever. PE (+) for tenderness to palpation of bilateral parotids, decreased neck suppleness. Assessment H/A.  Returned 10/14/08 with rash all over-erythmatous, papular lesions, slighly pruritic. Mild throat erythema. Assessment: R/O Varicella. URI. Referred for admission. Presented to ER with Varicella rash and 3 week hx of cough. Placed on Respiratory isolation and tx with Acyclovir with improvement.					Y				Y	09/23/2008	10/11/2008	18	Labs and Diagnostics: CXR WNL.	UNK	UNK	None	None	None. PMH: none at time of vax. Latent tuberculosis added to problem list 10/3/08			1						1	Chills; Cough; Decreased appetite; Headache; Nasopharyngitis; Oropharyngeal pain; Pyrexia; Rhinorrhoea; Skin lesion	FLUN3~MEDIMMUNE VACCINES, INC.~500560P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHAB128AB~2~IM~LA~HEP A + HEP B (TWINRIX)~1|MMR~MERCK & CO. INC.~0356X~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|MNQ~SANOFI PASTEUR~U2656AA~2~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C29988A~2~IM~RA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~0973X~UNK~SC~LA~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0330825	10/31/2008	SC	37.0			M	10/29/2008	Patient received influenza and pneumovax vaccinations on 10/1/08 in the clinic. Patient reported that on 10/2/08, he had new onset of head congestion, nasal congestion, headache with facial tenderness, feeling hot, generalized body aches, chest congestion with frequent cough of yellow secretions. Patient was seen to rule out pneumonia and dehydration due to fever and nausea and vomiting. Patient was treated with antibiotics, promethazine, acetaminophen and recovered. Symptoms: Fever, Wheeze, dehydration, nausea, vomiting.									Y	10/01/2008	10/02/2008	1	Chest x-ray - thickening area from infection; lungs + rhonchi bil	UNK	UNK	Doxycycline; Sodium Chloride; Acetaminophen		Secondary cardiomyopathy;  Hypertension;  Low back pain			1						1	Chest X-ray abnormal; Dehydration; Feeling hot; Headache; Nasal congestion; Nasopharyngitis; Nausea; Pain; Productive cough; Pyrexia; Respiratory tract congestion; Sinus congestion; Tenderness; Vomiting; Wheezing	FLUX~UNKNOWN MANUFACTURER~AFLLA181AA~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~0224X~UNK~IM~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0330826	10/31/2008	IL	68.0	68		F	10/03/2008	Pt developed very large raised, hot, red reaction over (R) deltoid area following administration of 2008 Flu vaccine and Pneumovax at adjacent sites. Also had severe headache with nausea and vomiting.										09/30/2008	10/03/2008	3	None	UNK	UNK			COPD; Ex smoker; Osteoporosis; Hx skin cancer			1						1	Erythema; Headache; Immunisation reaction; Nausea; Oedema peripheral; Skin warm; Vomiting	FLU3~SANOFI PASTEUR~U2744AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0963U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330827	10/31/2008	NC	21.0	21		M	10/28/2008	SM woke up with redness and swelling at site where he received his anthrax injection. SM also notes that he developed a HA after receiving his anthrax and FLUMIST shot that day. HA resolved the next day. Symptoms: Edema @ injection site 50-120mm, erythema, tenderness, headache, general, flu-like symptoms< 96 hours.									U	10/16/2008	10/17/2008	1		MIL	MIL	None	None	None			1						1	Erythema; Headache; Influenza like illness; Injection site erythema; Injection site oedema; Injection site swelling; Tenderness	ANTH~UNKNOWN MANUFACTURER~~UNK~SC~UN~ANTHRAX (NO BRAND NAME)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0330828	10/31/2008	NJ	37.0	37		F	10/22/2008	Given 10/20/08 @ 11:15 AM, 1:15 PM developed hoarseness, tightness in throat, felt SOB, coughing 3:00 PM. Came to nurse T 97.5, BP 103/70, P 72 Peak flow 350. Given BENADRYL 50 mg P.O. 7:00 PM - chills, fever, nausea - took ADVIL 400mg next morning - all symptoms resolved.									Y	10/20/2008	10/20/2008	0		OTH	OTH	None	None	None			1						1	Chills; Cough; Dysphonia; Dyspnoea; Nausea; Peak expiratory flow rate; Pyrexia; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA155AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0330833	10/31/2008	WV	14.0	14		F	10/29/2008	No adverse event. Flu vaccine labeled for adult use only administered in error to a 14 year old.									Y	10/27/2008				PUB	PUB		None	None		WV0829	1						1	Inappropriate schedule of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA173AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|MNQ~SANOFI PASTEUR~U2661AA~1~IM~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~UF452CA~1~IM~UN~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1015X~2~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0330836	10/31/2008	WV	3.0	3		F	10/29/2008	While administering 2nd half of FLUMIST dose to left nare pt jumped back while plunger was being pushed. Some of the FLUMIST went into patients right eye. Eye was flushed with water and no c/o blurring vision or pain. No adverse rx noted.									Y	10/29/2008	10/29/2008	0		PUB	OTH					WV0831	1						1	Accidental exposure	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB245AA~1~IM~UN~HEP A (HAVRIX)~1	USA		Influenza
0330837	10/31/2008	WV	12.0	12		M	10/29/2008	No adverse event. Flu vaccine labeled for adult use only administered in error to a 12 year old.									U	10/27/2008				PUB	PUB		None	None		WV0830	1						1	Inappropriate schedule of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA173AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|MNQ~SANOFI PASTEUR~U2661AA~1~IM~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~UF452CA~1~IM~UN~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1015X~2~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0330838	10/31/2008	PA	15.0	15		F	10/31/2008	During a break from basketball she looked in mirror and noted swelling around her eyes.  At the same time she developed some cough and a full feeling in her throat. These symptoms subsided within 30-40 minutes but eyes still swollen in am 10/31/08. (Also had contact with a dog before basketball)				Y					U	10/29/2008	10/30/2008	1	None	PVT	OTH		None	Allergic Rhinitis; history of asthma			1						1	Cough; Eye swelling; Throat tightness	FLU3~SANOFI PASTEUR~U2804AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0571X~1~IM~RA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0330839	10/31/2008	TX	24.0	23		F	10/20/2008	Patient got tingling sensation on her palm - and felt numbness on index and thumb of Lt hand, lasted for about an hour before diminishing.									Y	10/14/2008	10/14/2008	0		OTH	OTH	None	None	None			1						1	Hypoaesthesia; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88113~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330841	10/31/2008	PA	8.0	8		F	10/28/2008	None stated.				Y					Y	10/28/2008	10/28/2008	0		PVT	PVT	None	Allergies (No cough or FV)	None (since last WCC)			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2768AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330842	10/31/2008	VT	9.0	9		F	10/24/2008	Red hot deltoid 180 degrees around.  Not circumferential;  Tender to palp.  Started 24 hrs after shot given Tdap.				Y					Y	10/22/2008	10/23/2008	1	None	PVT	PUB	None	None	None			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U2829AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B06AA~1~IM~RA~TDAP (BOOSTRIX)~1	USA	Emergency room visit	Influenza
0330845	10/31/2008	VA	44.0	44		F	10/29/2008	pain in entire body.  Eyes are red.									U	10/28/2008	10/28/2008	0		PVT	PVT	None	None	Allergic Rhinitis	fluwish~Influenza (Seasonal) (no brand name)~1~29.00~In Patient		1						1	Ocular hyperaemia; Pain	FLU3~SANOFI PASTEUR~U2805AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330846	10/31/2008	PA	46.0	46		F	10/28/2008	AFLURIA vaccine given on L deltoid, within next 3 hours an indurated area formed approximately 3 in diameter.  Redness then developed on entire deltoid area extending into the axilla and onto L anterior chest wall.  Area warm to touch.  By 10/28/2008 pm- redness receding, warmth remains, decreased induration @ injection site small amt soreness.									Y	10/27/2008	10/27/2008	0	None	PUB	PVT						1						1	Erythema; Injection site erythema; Injection site induration; Injection site pain; Injection site warmth	FLU3~CSL LIMITED~01749111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0330849	10/31/2008	NJ	83.0	83		M	10/27/2008	Symptoms started @ 10PM 10/17/08.  Pt c/o chills fever, achey muscles, lethargy.  Pain in back, decrease appetite- 1 wk duration.  Wife has same signs + symptoms but had no flu shot.									Y	10/17/2008	10/17/2008	0	None	PUB	UNK	Vitamin E;  ASA 81 mg; DIGOXIN; ZETIA; Vitamin; UNI-THERAM;  PRIPIVAL;  LIPITOR; TAR Advances;  DIQITEK;  FUROSEM; METOPROL;  LISINOPRIL;  AMLODIPINE	None	Weak heart muscle			1						1	Back pain; Chills; Decreased appetite; Lethargy; Myalgia; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~87923~7+~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330850	10/31/2008	MS	24.0	24		F	10/24/2008	Itchy, redness x 1 week after injection @ injection site.									Y	10/16/2008	10/17/2008	1	None	PUB	OTH	None	None	None			1						1	Injection site erythema; Injection site pruritus	FLU3~CSL LIMITED~02449111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0330851	10/31/2008	OR	45.0	45		M	10/27/2008	Severe L arm pain continuing 2 weeks post injection, causing decrease in mobility and causing shoulder pain when trying to raise L arm above head.									U	10/09/2008	10/10/2008	1	None	OTH	PVT		Not ill	pos. tests for mold/house dust/cats		OR200835	1						1	Injected limb mobility decreased; Musculoskeletal pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3588A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330854	10/31/2008	FL				F	10/26/2008	Pt presented to pharmacy sunday 10/26/08 with dermatitis in L deltoid area.  Area approximately 3x2 raised, red area.									Y					OTH	PUB						1						1	Dermatitis; Erythema; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330855	10/31/2008	OR	57.0	57		F	10/25/2008	10-22 shot L deltoid 11:45 AM.  45 minutes later , sore site, began to cough, then wheezing, mild, then eyes bloodshot & oozing thick exudate.  Went home 3:30.  Chills + muscle aches off + on x 5 hours 1:00 pm.  Perfect health following day 10-23-08.										10/22/2008	10/22/2008	0	None	PUB	OTH	None	None	None			1						1	Chills; Cough; Eye discharge; Injection site pain; Myalgia; Ocular hyperaemia; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA364BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330856	10/31/2008	NM	71.0	71		F	10/24/2008	Pt states Right after I was given the PNEUMOVAX, the whole muscle begin to hurt.  Later in the afternoon the inj site was swollen, painful & hot No redness, later in day the back of upper arm became painful & hot.  By the evening, pt's whole arm from elbow to shoulder was very painful.  She was unable to lift her arm or really use it due to the pain.  No fever, N,V.  Pt called on 10-22-08.  We had her come in to be seen.  The pain at injection site was less but the pain on the tricep area still was very painful.  It was hot to the touch + very painful even with a light touch.  There was a lump in that area also.  Pt was seen by Dr + sent home with dx of 'adverse reaction to drugs.  NOS.'  Pt was told to take BENADRYL 1-2 tabs every 6 hrs + a recheck visit was made for the next day.  Pt seen again on 10-23-08.  The site of the injection was less painful out continued to be more painful then inj.  site, Pt was able to use her arm + lift.  At the tricep area, it was still warm with the lump.  The lump at the inj. site was gone.  Dr said for pt to continue with BENADRYL and call if it got worse or not better.									Y	10/21/2008	10/21/2008	0	Adverse reaction to drugs, NOS	PVT	PVT		None				1						1	Immediate post-injection reaction; Injected limb mobility decreased; Injection site mass; Injection site pain; Injection site swelling; Injection site warmth; Myalgia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89880~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1295X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330857	10/31/2008	AZ	45.0	45		F	10/24/2008	Face red/raw.  Tightness to chest.  Numbness to mouth				Y					Y	10/23/2008	10/23/2008	0		PVT	PVT		No Known Illness				1						1	Chest discomfort; Erythema; Hypoaesthesia oral	FLU3~CSL LIMITED~01749111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0330858	10/31/2008	VA		0	.0	M	10/28/2008	Patient given flu shot 10/27/08.  C/o headache, disorientation, generalized weakness, lightheadedness.										10/27/2008	10/27/2008	0	CBC- nl chem 7 - nl ESR - 2M	PVT	OTH		None	NKDA, Obesity, OSA, Hyperlipedemia			1						1	Asthenia; Disorientation; Dizziness; Full blood count normal; Headache; Laboratory test normal; Red blood cell sedimentation rate decreased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~9000888636~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330860	10/31/2008	VA	1.4	1	.4	M	10/27/2008	Seemingly dizzy and off balance.  Falling to his left side.									N	10/24/2008	10/25/2008	1	None	PVT	PVT	None					1						1	Balance disorder; Dizziness; Fall	FLU3~SANOFI PASTEUR~UT278799~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330861	10/31/2008	CA				F	10/22/2008	After 2 hrs Pt has stomach cramps, later asthma sx increased, had a few palputation.  Took IBUPROFEN.  In evening had fever + chills.  Next day (10/22) feels better.									Y	10/21/2008	10/21/2008	0		OTH	PVT		No				1						1	Abdominal pain upper; Asthma; Chills; Palpitations; Pyrexia	FLU3~SANOFI PASTEUR~U2748AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330863	10/31/2008	MO	70.0	70		F	10/24/2008	C/o sore arm, redness since Wednesday.  Stated felt nauseated, weak & no appetite, & temp of 100 degrees on Thursday.  States feels better today.  Instructed to notify MD if symptom worsen, ice for arm & over the counter pain reliever.									Y	10/21/2008	10/22/2008	1	None	PUB	PVT		None	Recent hospitalization for COPD			1						1	Anorexia; Asthenia; Body temperature increased; Erythema; Nausea; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA188AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1381U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330865	10/31/2008	CO	8.0	8		F	10/21/2008	After waiting our required 20 minutes after vaccine 5:05 pm we left. Upon arriving home she complained of her tummy hurting and didn't eat dinner at 5:30 pm. Laid on bed holding tummy. She felt warm but not hot. At approx 6:30-6:45 pm she vomited and had diarrhea not making it to bathroom, everything. Vomiting continued every 1/2 hour to 45 min. until midnight then again at 2 am on 10-15-08. She couldn't drink water. Dry heaves again at 3 am. She was able to sleep off and on until 6:30 am on 10-15-08. She missed school that day. (10-15-08).									Y	10/14/2008	10/14/2008	0		PVT	UNK		None	Augmentin allergy, seasonal allergies (nasal)			1						1	Abdominal pain upper; Diarrhoea; Feeling hot; Hypophagia; Retching; Vomiting	FLU3~SANOFI PASTEUR~U272588AA~7+~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330866	10/31/2008	TX	5.0	5		F	10/21/2008	Developed generalized urticaria rash on body on the evening after flu shot.									Y	10/20/2008	10/20/2008	0		PVT	PVT		None	None			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2806AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330867	10/31/2008	MO	19.0	19		F	10/23/2008	While drinking hot cocoa, she got lightheaded, warm feeling and nauseated.  30 minutes after onset, she vomited.  She felt better a few hours after injection.									Y	10/22/2008	10/22/2008	0	None	OTH	OTH	SEROQUEL;  TOPANAX;  LAMICTAL	None	Bipolar;  Social anxiety			1						1	Dizziness; Feeling hot; Nausea; Vomiting	FLU3~CSL LIMITED~03549111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0330868	10/31/2008	MO	43.0	43		M	10/23/2008	35 minutes after injection.  Dizziness, nausea, irritable, vertigo, flushed.  Felt better after several hours.									Y	10/22/2008	10/22/2008	0	Vital signs normal during and after	OTH	OTH	None	None	None			1						1	Dizziness; Flushing; Irritability; Nausea; Vertigo	FLU3~CSL LIMITED~03549111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0330869	10/31/2008	WY	56.0	56		F	10/27/2008	Arm very sore at vaccination site.  The evening immediately after vaccination throat became red & sore.  For 2 weeks following was fatigued and had flul like/cold symptoms.  Treated with rest & fluid juices. No vomiting or dia.										10/06/2008	10/06/2008	0	None	PUB	PVT			M. S.			1						1	Fatigue; Influenza like illness; Injection site pain; Oropharyngeal pain; Pharyngeal erythema	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330871	10/31/2008	IN	47.0	47		F	10/28/2008	Face & neck started swelling at 11:00 P.M. on 10/23/2008.  No improvement by 10/26/2008.  Physician evaluated her and said she had parotitis with retained fluid.  Instructed her to take BENADRYL + IBUPROFEN.  Some improvement by 10/27/2008.  Nurse pract.  ordered CBC (WNC).  Continued improvement 10/28/08.				Y					Y	10/23/2008	10/23/2008	0	CBC drawn 10/27/08 (WNC) normal	PUB	OTH	SYNTHEROID;  LEXAPRO;  Baby Aspirin	Mild sinus problems	Hypothyroidism;  Anxiety	knot/swelling @ injection site for 2 weeks~Tdap (no brand name)~~46.00~In Patient		1						1	Fluid retention; Full blood count normal; Local swelling; Parotitis; Swelling face	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89975~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0330872	10/31/2008	FL	73.0	73		F	10/25/2008	Arm with localized pain.  Swelling & bruising- treated with TRAMADOL.				Y					U	10/14/2008	10/15/2008	1	None	PVT	PVT	ASA; BENICAR;  HCT;  ALLEGRA; ZOCOR	None	HTN;  Hyperlisidema			1						1	Contusion; Pain in extremity; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA153BA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0330884	10/31/2008					U	10/28/2008	10/8/08 patient received flu vaccine.  10/13/08 patient states she was itchy all over with a rash, and had burning sensation.  10/15/08 patient has hives and woke up with eyes swollen shut.  10/16/08 patient had hives in morning, but clearing up as day progressed.											10/08/2008			UNK	UNK			Was told many years ago that she had sensitivity to the THIMERASOL in contact lens solution.  Eyes became irritated.  Stopped using that solution.			1						1	Burning sensation; Eye swelling; Pruritus generalised; Rash generalised; Urticaria	FLU3~SANOFI PASTEUR~U2810AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330890	10/31/2008	AR	82.0	82		F	10/23/2008	Itching & swelling at injection location pretty intense reaction - but no breathing problems.									Y	10/17/2008	10/17/2008	0		OTH	PUB		No				1						1	Injection site pruritus; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89966~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0867X~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330895	10/31/2008	GA	78.0	78		F	10/08/2008	Client broke out into widespread rash on upper torso one hour after receiving FLUZONE.  Client took CLARITIN - applied topical cream and arrived at hospital ER at 4:45 PM-  She was stable- given prescription for PREDNISONE 20 mg BID x 3 days every 6 hours.				Y					Y	10/07/2008	10/07/2008	0	None	PUB	PVT	LISONOPRIL 20 mg daily;  ATENOLOL 100-25 mg daily;  PRESVOSTAN 40 mg daily	None	Allergic to CODEINE;  Hx Hypertension;  Hypercholesterolemin		GA08079	1						1	Rash	FLU3~SANOFI PASTEUR~U274BAA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330896	10/31/2008	GA	57.0	57		F	10/10/2008	Patient received Flu and Pneumonia vaccine.  Pt says she took a nap when she got home.  Later that afternoon she woke up with her arm sore swollen and she felt really bad.  Pt called RCHD 10/10/05, states she feels very tired and sick and arm still hurts.  Ask pt. if she has any fever and if she contacted her doctor.  States no she hasn't.  Encouraged to call doctor for appointment.				Y					Y	10/08/2008	10/08/2008	0	None	PUB	PVT	None	None	None		GA08080	1						1	Fatigue; Feeling abnormal; Malaise; Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~NOV89126~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0989~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0330897	10/31/2008	GA	69.0	69		F	10/16/2008	Flu vaccine given at 11:46 am on 10/14/08. Pt. started coughing at 10:30 pm- To ER for difficulty breathing. Given IV SOLUMEDROL, BENADRYL and ATIVAN. Adm to hosp with cough and allergic Rx. D/C on 10/14.  11/11/08 Reviewed hospital medical records of 10/14-10/15/2008. FINAL DX: cough, allergic reaction  Records reveal patient experienced severe intractable cough & hoarseness which could not be controlled in ER w/bronchodilators & steroids.				Y	Y	2			Y	10/14/2008	10/14/2008	0	Chest x-ray, EKG, CBC, CMP, PT, PTT, BS  LABS: CXR & EKG WNL.  WBC 8.7(N), neutros 89.1%(H), lymphs 10.1%(L), monos 0.7%(L).  Chemistry WNL except glucose 184(H).	PUB	OTH	Benzonatate; Coumadin; Pepcid; Metformin; Simvastatin	No	Sulfa; PCN; Aspirin  PMH: diverticulitis, type II DM, cirrhosis, PVD, DJD, irregular heart beat & on anticoagulant.  Allergy: zithromax, ceclor, c-mycin.		GA08081	1						1	Activated partial thromboplastin time; Cough; Dyspnoea; Full blood count; Hypersensitivity; Metabolic function test; Prothrombin time	FLU3~SANOFI PASTEUR~89750~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0330898	10/31/2008	GA	47.0	47		F	10/16/2008	Presented to ER at 20:20 with c/o difficulty breathing. Treated in ER with IV SOLUMEDROL and BENADRYL. Admitted to hosp. with allergic reaction and stridor. D/C home 10/15/08 at 3:00 pm on MEDROL DOSE PK.   11/11/08 Reviewed hospital medical records of 10/14-10/15/2008. FINAL DX: allergic reaction to flu vaccine w/acute respiratory distress Records reveal patient experienced hoarseness, SOB & stridor.  Tx w/IV steroids & antihistamine.  Improved & d/c to home on continued oral meds & tapering steroids.				Y	Y	1			Y	10/14/2008	10/14/2008	0	Chest x-ray	PUB	OTH		None	CELEBREX; aspirin; codeine  PMH: HTN, hypothyroidism, hyperlipidemia, ex-smoker.		Ga08082	1						1	Chest X-ray; Dyspnoea; Hypersensitivity; Stridor	FLU3~SANOFI PASTEUR~U2765AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0330914	10/31/2008	KY				U	10/31/2008	Swollen arm down into hand.  Throbbing/pain in arm and hand.  MD stated reaction needed to be reported. Pt had had influenza vaccine every year for the past several years.  Pt had a liver transplant approx 5 years ago.				Y						10/17/2008	10/18/2008	1		PUB	PUB			Had liver transplant 5 years ago.			1						1	Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~U2811AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330915	10/31/2008	OK	76.0	76		F	10/31/2008	Pt reports that she took a flu shots and twelve hours later developed hives and a rash over her body.  Pt taking Benadryl with no relief.										10/29/2008	10/30/2008	1	none	PUB	PUB	unknown	unknown	unknown	unknown~ ()~NULL~~In Patient		1						1	Rash generalised; Urticaria	FLU3~SANOFI PASTEUR~U2772AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330916	10/31/2008	NY	8.0	8		M	10/31/2008	On October 27, 2008 flu vaccine administered to deltoid region of left arm at around 3:30pm. Mom called on October 28th to report redness and induration at the site. She come in at 3:15 on the 28th to be seen by Dr. The area was noted by Dr. to have a reddened area about 3 1/2 to 4 inches around the injection site and a moderately sized hive near the site. The doctor ordered benedryl 25mg 3-4 times/day and ice to the site. PHN spoke with Dad on 10/31. Dad reports arm is completely cleared.									Y	10/27/2008	10/28/2008	1	none	UNK	UNK	none	no	none			1						1	Injection site erythema; Injection site induration; Injection site urticaria	FLU3~SANOFI PASTEUR~U2770AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330917	10/31/2008	IA	40.0	40		F	10/31/2008	Patient received vaccine on 10/28/08 and called this morning reporting redness and swelling by injection site and a rash. Flat rash not raised on arms, torso, legs.									U	10/28/2008	10/29/2008	1		UNK	UNK	vytorin, niaspan, fluticasone	no	asthma, environmental allergies			1						1	Injection site erythema; Injection site swelling; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89979~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330918	10/31/2008	NC	9.0	9		M	10/31/2008	Arthralgias in arms and legs within 24 hours of administration									U	10/29/2008	10/30/2008	1		UNK	UNK	Allegra	None	Allergic rhinitis			1						1	Arthralgia	FLU3~SANOFI PASTEUR~U2765AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330920	10/31/2008	OH	47.0	46		F	10/31/2008	Edema of the face and mouth and throat.									Y	10/15/2008	10/15/2008	0		UNK	UNK						1						1	Face oedema; Oedema mouth; Pharyngeal oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflla165aa~4~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0330922	10/31/2008	NE	45.0	45		F	10/31/2008	One episode of dizziness approx 36 hours after influenza vaccine injection followed by slow onset of red fine macular rash over trunk. Presented to clinic 2 days afer vaccination, given loratadine, rash resolved on 10-30-08.									Y	10/27/2008	10/28/2008	1		PVT	UNK	Verapamil, flexeril	none	Known allergy to azithromycin			1						1	Dizziness; Rash erythematous; Rash macular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA356AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0330923	10/31/2008	NC	51.0	51		F	10/31/2008	passed out, vomited, increased heart rate, headache, high blood pressure				Y					N	10/30/2008	10/30/2008	0		UNK	UNK						1						1	Headache; Heart rate increased; Hypertension; Loss of consciousness; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0330924	10/31/2008	MN	55.0	55		F	10/31/2008	Difficulty breathing, hoarseness/wheezing, coughing, fever, chills,weakness, fast heart beat, general aches.  This came on slowly about 3 hours after the shot, and gradually built up.  In a matter of 7 hours, it was over, and I felt fine.									Y	10/28/2008	10/28/2008	0		UNK	PVT	Premarin, effexor & Ibueprofin	none	xray die causes hives.			1						1	Asthenia; Chills; Cough; Dysphonia; Dyspnoea; Heart rate increased; Pain; Pyrexia; Wheezing	FLUX~UNKNOWN MANUFACTURER~unknown~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330925	10/31/2008	MT	80.0	80		M	10/31/2008	Seven days after he recieved the Flu vaccine, he had 100% of his body covered in hives. He went to the hospital and they gave him Decadron.  He still has the hives and they come and go. They will flair up instantly and go away within 2 hours and then come back.				Y					U	10/14/2008	10/21/2008	7		PUB	PVT	Prilosec	No	No			1						1	Urticaria	FLU3~CSL LIMITED~01349111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0330926	10/31/2008	OK	58.0	58		F	10/31/2008	returned to work past injection in evening started itching all over and SOB states was dizzy, felt heart pounding called and reported this on 10/27/08 states she then took a benadryl and went to sleep. states woke up again next morning felt better but remained nauseated and SOB but felt this was related to her hx of asthma. Has a Doctor appt on 10/29/08.									Y	10/24/2008	10/24/2008	0	when talked with client on 10/30/08 states instead of seeing md in office was sent to ER because she complained of chest pain. she said they stated she had pleurisy.	PUB	PUB						1						1	Chest pain; Dizziness; Dyspnoea; Nausea; Palpitations; Pleurisy; Pruritus generalised	FLU3~SANOFI PASTEUR~U2811AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330931	10/31/2008	IN	65.0	65		F	10/31/2008	Flu shot was given above the proper muscle, given in the burses(sp?)  It has left me with painful use of my arm and my current Dr. feels I need therpy to get the use back in my arm.				Y					N	10/09/2008	10/09/2008	0	Needs Physical Therepy in right arm	UNK	UNK		None  Unable to detertermine mfg of vacine.	None			1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2807AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330933	10/31/2008	CA	67.0	67		F	10/31/2008	On 10/04/08 P. called to report arm was hot, swollen, and red.  Advised to use tylenol and ice. On 10/06/08 pt. saw MD for same complaints and fever. Pt. took keflex for 7 days but got bad stomach upset and stopped. 10/27/08 pt. called to say still has swollen lymph nodes with pain.									Y	10/02/2008	10/04/2008	2		UNK	PVT						1						1	Erythema; Lymph node pain; Lymphadenopathy; Oedema peripheral; Pyrexia; Skin warm; Stomach discomfort	FLU3~CSL LIMITED~00849211A~4~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~0200U~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330935	10/31/2008	MO	49.0	49		F	10/31/2008	Pt reported Influenza injection at 9:00am on 10/30/08. This was her first flu shot.  Nose started running aprox. 9:15am with sneezing and watery eyes following.  Started uncontrollably coughing and chilling.  Felt hot to touch but no temperature was taken.  Felt Short of Breath and begin wheezing when went to Emergency Room aprox. 4:30pm.  Was treated in Emergency room at 1725 with Benadryl, prednisone and pepcid. Was diagnosed in ER with Allergic reaction to Flu shot.				Y					Y	10/30/2008	10/30/2008	0	none	UNK	PVT	vitamins, iron	none	none			1						1	Chills; Cough; Dyspnoea; Feeling hot; Hypersensitivity; Lacrimation increased; Rhinorrhoea; Sneezing; Wheezing	FLU3~SANOFI PASTEUR~U2810AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330936	10/31/2008	MN	2.0	2	.0	M	10/31/2008	Swollen eyes, hives over trunk of body, legs, back, arms, neck				Y					Y	10/28/2008	10/29/2008	1	Allergic reaction	PUB	UNK		None	Allergic to peanuts			1						1	Eye swelling; Hypersensitivity; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0330937	10/31/2008	FL	63.0	63		F	10/31/2008	RED 3 INCH CIRCULAR RASH AT INJECTION SITE THAT APPEARED THE NEXT MORNING AFTER GETTING SHOT. CONTACTING HER DR. OFFICE AND THE NP/PA PRESCRIBED HER A MEDROL DP, AND USE COLD COMPRESSES. I ADVISED PT TO CALL ME TOMM. TO CHECK ON HER AND CALL IMMEDIATELY TO GET HELP IF IT WORSENS.  11/3/08 Per patient-no permanant disability. Pt recovered from rash. No f/u required									N	10/30/2008	10/31/2008	1	NA	UNK	UNK						1						1	Injection site rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA157AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0330938	10/31/2008	SC	57.0	57		F	10/20/2008	On 10/06/08, an employee received an IM influenza, in left arm.  After several days, per the employee, her left arm was warm to touch, swollen and discolored.  By 10/14 area of discoloration spread down to elbow.  During this time the employee was out of work because of another medical problem.  On 10/20/08, when the employee reported the above incident to the Employee Health Nurse, there was no swelling but discoloration approximately one (1) inch below the injection site to elbow.  Discolored area measured approximately 29 inches  wide and 15 inches long.  The area covered the outer aspects of the left arm to the elbow.  The discoloration was a deep purplish color.  Employee stated area was  not painful or warm to touch, but some tenderness. As of today (10/28/08), the employee left arm has improved considerably. Area now measures approximately five inches wide and 12 inches long.  The area is mostly on the inner aspects of the arm above elbow.  The discoloration varies from a slight purplish to yellow.  Employee states the discolored area is a little sore but no tenderness at the sight of the influenza vaccination.									N	10/06/2008	10/08/2008	2	None	PUB	PUB	Evista, Doxycycline, Diazide, Vit E,C, B12,	none	Takes allergy drops.  Allergic to shellfish and has hayfever.		SC0812	1						1	Oedema peripheral; Skin discolouration; Skin warm; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330941	10/31/2008	NY	15.0	15		F	10/31/2008	No adverse event.  Pt received Afluria -Influenza vaccine- vaccine to be given to age 18 and above.  this individual is 15 yrs old										10/27/2008			N/A	PUB	PVT	None	None	none			1						1	Inappropriate schedule of drug administration	FLU3~CSL LIMITED~01349111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|TDAP~SANOFI PASTEUR~C2688AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0330943	10/31/2008	MO	66.0	65		F	10/31/2008	Pt report she got Influenza injection aprox. 10:30am on 10/30/08.  at aprox 3:45pm she noticed throat closing up, eyes got red and swollen and throat felt burning hot  Went to ER at 4:00pm was seen at 1618 in Emergency Room and was treated with Benadryl, prednisone, and pepcid.  Pt also reports she has been on Penicillian for 2 weeks and took a dose at aprox 3:00pm				Y					Y	10/30/2008	10/30/2008	0		UNK	PVT	zantac	foot surgery aprox 2 weeks ago	none			1						1	Eye swelling; Ocular hyperaemia; Throat irritation; Throat tightness	FLU3~SANOFI PASTEUR~U2810AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330944	10/31/2008	WI	5.0	5		M	10/31/2008	Mother called today and states that noticed yesterday red raised walnut area on left upper arm, where the MMR was given and was still red a raised this morning. Instructed to come into center to have area looked at, as this is closer to there home, states she will if not better when she picks him up at 3:30 today.				Y					U	10/29/2008	10/30/2008	1		UNK	UNK		NONE				1						1	Injection site erythema; Injection site swelling	DTAP~UNKNOWN MANUFACTURER~AC14B064AA~2~IM~LA~DTAP (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U2739AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0805~2~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0890X~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1976U~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0330945	10/31/2008	IN	74.0			F	10/31/2008	PATIENT COMPLAINED OF A VERY SORE ARM FROM A FLU SHOT 3 WEEKS AGO.  SHE HAS HAD THE SORE ARM SINCE VACCINATION AND STILL HAS TROUBLE LIFTING IT UP.									N				PATIENT IS GOING TO SEE HER DOCTOR NEXT WEEK.	UNK	PUB		NONE	HYPOTHYROIDISM			1						1	Injected limb mobility decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA169AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0330946	10/31/2008	CA	48.0	48		F	10/31/2008	coughing, swollen tongue, area under the tongue swollen, fever 100, chills, swollen eyes, discharge from eyes, headache									Y	10/29/2008	10/29/2008	0	none	UNK	UNK		none	allergies to dust, pollen, cats			1						1	Chills; Cough; Eye discharge; Eye swelling; Headache; Pyrexia; Swollen tongue	FLUX~UNKNOWN MANUFACTURER~0~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330947	10/31/2008	WY	4.0	4		M	10/31/2008	Patient received Influenza vaccine 10/17/08. At 4:00 pm on 10/19/08 mother noticed patient's right arm was red, swollen and hot at 8:45 pm mother took patient to ER. Patient was seen by Dr. Mother was told patient had developed cellulitis and was started on Clindomicin-75 mg, 4x daily for 7 days. Patient followed up with MD on 10/20/08. Dr. diagnosed patient with an allergy to something in the vaccine. Lab work was drawn but results are not back as of yet.				Y					Y	10/17/2008	10/19/2008	2	Dr. drew blood work for allergy testing.	UNK	UNK						1						1	Blood test; Cellulitis; Hypersensitivity; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2765AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330949	10/31/2008	WY	10.0	10		F	10/31/2008	Patient received influenza vaccine on 10/30/08. Approximately 30 seconds after receiving vaccine patient patient exhibit very short seizure like activity and loss consciousness, she was incontinent of bladder. Pattient was lowered to the floor by public health nurses and oxygen was applied. An ambulance was called but mother refused transport. Mother was strongly encouraged to have patient seen in the ER and to follow up with patient's physician. Mother stated she would do this.									Y	10/30/2008	10/30/2008	0		UNK	UNK			Mother states patient had a seizure in a store this past year.	Seizure type activity and loss of consciousness~Influenza (Seasonal) (Fluzone)~1~7.80~In Patient		1						1	Convulsion; Loss of consciousness; Urinary incontinence	FLU3~SANOFI PASTEUR~U2765AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330950	10/31/2008	IA	39.0	39		M	10/31/2008	patient received vaccine on 10/28/08 and this morning found a flat rash on his legs and reddness around site of injection.  He stated today for the 1st time that he recently had a sinus infection and was taking Bactrim as an antibiotic.  He took his last Bactrim this morning.									U	10/28/2008	10/31/2008	3		UNK	PVT	Ibuprofen	yes, reported today that he has a sinus infection.				1						1	Injection site erythema; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89979~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330951	10/31/2008	TN	11.0	11		M	10/31/2008	Fever 101-103 degrees for over 24 hours at time of filing form. An increase in asthma symptoms. sore throat. at time of filing symptoms are not resolved. Will be returning to physician in the morning, urgent care clinic visit due to it will be a saturday.				Y					U	10/30/2008	10/30/2008	0		PVT	PVT	takes vyvanse, advair, albuterol	asthma	asthma, adhd	fever over 104 for 48 hours, listless, lethargy, decreased responsiveness~DTP + Hib (no brand name)~UN~0.90~In Sibling1		1						1	Asthma; Oropharyngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~on file dr~3~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0330952	10/31/2008	CO	48.0	48		F	10/31/2008	pt developed redness, swelling, at injection site on left deltoid									Y	10/21/2008	10/21/2008	0		UNK	PVT	unknown					1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~u2753aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330973	10/31/2008	VA				M	10/31/2008	This case was reported by a physician via an injectables and vaccines distributor and described the occurrence of convulsion in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline).  On 21 October 2008 the subject received a dose of FLULAVAL (unknown).  At an unspecified time after vaccination with FLULAVAL, the subject experienced convulsion.  It was suggested that the subject was seen in the emergency room.  Limited information was available.  This case was assessed as medically serious by GSK.  At the time of reporting the outcome of the event was unspecified.  The person reporting this event was a distributor who sold the product to another distributor who then sold it to a medical doctor's office.  The medical doctor's office contacted the second distributor with the limited information.  It was reported that three subjects experienced convulsions and a female subject experienced a drop in her blood sugar and weakness and was taken to the emergency room.  Linked case numbers include A0754338A and A0754339A.				Y					U	10/21/2008			UNK	PVT	OTH		Unknown	Linked case numbers include A0754338A and A0754339A.		A0754328A	1						1	Convulsion	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0330974	10/31/2008	VA				M	10/31/2008	This case was reported by a physician via an injectables and vaccines distributor and described the occurrence of convulsion in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 21 October 2008 the subject received a dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced convulsion. It was suggested that the subject was seen in the emergency room. Limited information was available. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. The person reporting this event was a distributor who sold the product to another distributor who then sold it to a medical doctor's office. The medical doctor's office contacted the second distributor with the limited information. It was reported that three subjects experienced convulsions and a female subject experienced a drop in her blood sugar and weakness and was taken to the emergency room. Linked case numbers include A0754328A and A0754339A.				Y					U	10/21/2008			Unk	PVT	OTH		Unknown	Linked case numbers include A0754328A and A0754339A.		A0754338A	1						1	Convulsion	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0330975	10/31/2008	VA				F	10/31/2008	This case was reported by a physician via an injectables and vaccines distributor and described the occurrence of convulsion in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline).  On 21 October 2008 the subject received a dose of FLULAVAL (unknown).  At an unspecified time after vaccination with FLULAVAL, the subject experienced convulsion, a drop in her blood sugar down to 46 and weakness.  She was taken to the emergency room.  Limited information was available.  This case was assessed as medically serious by GSK.  At the time of reporting the outcome of the events was unspecified.  The person reporting this event was a distributor who sold the product to another distributor who then sold it to a medical doctor's office.  The medical doctor's office contacted the second distributor with the limited information.  It was reported that three subjects experienced convulsions and a female subject experienced a drop in her blood sugar and weakness and was taken to the emergency room.  Linked case numbers include A0754328A and A0754338A.				Y					U	10/21/2008			Blood sugar decreased, 46	PVT	OTH		Unknown	Linked case numbers include A0754328A and A0754338A.		A0754339A	1						1	Asthenia; Blood glucose decreased; Convulsion	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0330982	10/31/2008	OK	29.0	29		F	10/31/2008	Localized redness; swelling at site of injection. Area was approx. 3-4 in diameter, hot to touch. 10 am. Ice applied to site. 50 mg of PO BENADRYL given. Patient was c/o nausea, heart palpitations, weakness, pupils dilated, face was flushed. BP 118/70 P 102. EMS called at 1022. Pt transported by ambulance to medical center.  11/11/08 Reviewed hospital medical records of 10/31-11/5/2008 FINAL DX: no d/c summary available.  H&P states allergic reaction to vaccine Records reveal patient experienced immediate injection site pain, swelling & redness, palpitations, passed out, rash, paresthesia of extremities & face, & HA.  No reaction to previous flu shots.  Seen in ER, treated w/antihistamines & steroids.  Improved & d/c to home.  Developed difficulty swallowing & returned to ER.  Again tx w/steroids.  Neuro, allergy & ID consults done.				Y	Y	6			U	10/30/2008	10/30/2008	0	LABS: CXR, EKG & CT of head WNL.   Glucose 145(H), BUN/creatinine ratio 22.2(H) 10/31/08 02:14; WBC, 9.3 (4.2-11.2); RBC, H 5.28 (3.80-5.00); Hgb, H14.9 (11.6-14.8); Hct, 42.0 (33.6-44.0); MCV, L 79.5 (81.8-96.9); MCH, 28.3 (28.0-33.0); MCHC H 35.6 (33.0-35.0); RDW, 12.4 (112-13.7); Platelet, 308 (150-450); MPV, L 7.4 (9.0-13.0); Seg, H 86 (40-64); Lymph, L 10 (22-44); Monocytes, 3 (0-7); Eosinophils, 0 (0-10); Basophils, 0 (0-2); Sodium, 143 (136-145); Potassium, 3.7 (3.5-5.0); Chloride, 104 (98-107); Carbon dioxide, L 21.0 (22.0-29.0); Glucose, H 223 (70-110); BUN, 12 (6-20); Crestinine, 0.9 (0.6-1.3); Calcium, H 10.2 (8.6-10.0); Total Protein, H 8.8 (6.4-8.3); Albumin, H 5.2 (3.4-4.8); AG Ratio, 1.6 (1.0-2.0); Bilirubin Tot, 0.4 (0.3-1.2); Alkaline Phos, 69 (40-134); ALT, 22 (7-35); AST, 20 (8-45); Anion Gap, H 21.7 (10.0-20.0); Bun Creat Ratio, 13.3 (12.0-20.0); ESR Westergren H 22 (0-20); 10/31/08 02:49; CT head Wo Contrast, - CT Head Wo Contrast; 10/31/08 03:38; ER Chest Single View, - ER Chest Single View; 10/31/08 15:45; H and P, H and P, Unauthenticated; 10/31/08 20:25; Punc Site, Right Radial; pH Blood, H 7.52 (7.37-7.43); PCO2 L 26 (38-42); PO2, H 149.0 (85.0-100.0); HCO3, L 21 (22-26); BE, -2 (-2-2); O2 Satur, H-98 (94-97); Allens Test, Positive; Oxygen Mode, Nasal Cannula; O2 LPM, 2.00; 10/31/08 22:35; EKG, EKG, Unauthenticated; EKG, EKG, Unauthenticated; 10/31/08 00:47; Clinical Height (feet) 5; CLINICAL HEIGHT  (inches) 1.0; Clinical Weight (pounds 155.00; CLINICALWEIGHT, 70.45; 11/04/08 16:28; CONSULTATION,  CONSULTATION, Unauthenticated; 11/05/08 09:10; Sodium, 138 (136-145); Potassium, 3.8 (3.5-5.5); Chloride, 100 (98-107); Carbon Dioxide, 28.0 (22.0-29.0); Glucose, H 145 (70-110); BUN, 20 (6-20); Creatinine, 0.9 (0.6-1.3); Calcium, 9.8 (8.6-10.0); Anion Gap, 13.8 (10.0-20.0); Bun Creat Ratio, H 22.2 (12.0-20.0); Phosphorus, 4.5 (2.7-4.5); PTH intact, 40.3 (6.8-55.1); HGB A1C, 5.7 (0.0-6.0)	PUB	PUB	HCTZ 3x wk 20mg; PREVACID 30mg QD	None	Lupus; Cerebral Palsy; Allergic-ZITHROMAX, PERCOCET, morphine, iodine   PMH: GERD, kidney stones, allergic rhinitis.			1						1	Albumin CSF increased; Allen's test; Anion gap increased; Asthenia; Basophil count normal; Blood alkaline phosphatase normal; Blood bilirubin normal; Blood calcium increased; Blood chloride; Blood phosphorus; Blood potassium; Blood sodium; Carbon dioxide decreased; Carbon dioxide normal; Eosinophil count; Erythema; Flushing; Haematocrit; Haemoglobin increased; Heart rate increased; Injection site erythema; Injection site swelling; Injection site warmth; Laboratory test; Lymphocyte count decreased; Mean cell haemoglobin concentration; Mean cell haemoglobin normal; Mean cell volume increased; Mean platelet volume decreased; Monocyte count normal; Mydriasis; Mydriasis; Nausea; Oxygen saturation; PCO2 decreased; Palpitations; Platelet count normal; Protein total increased; Red blood cell count increased; Red blood cell sedimentation rate increased; White blood cell count	FLU3~SANOFI PASTEUR~U2790BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0330984	10/31/2008	AK	74.0	74		F	10/10/2008	Rt shoulder pain, swollen, swelling into fingers, cannot close fist or lift arm, redness over deltoid. Ultrasound showed huge glenohumeral joint effusion, tapped it = WBC 86K, 90% poly. No organism seen. Surgery - Irrigation & debridement of shoulder - 20mL purulent material.  11/21/2008  MR received for DOS 10/8-10/2008 with DX: Right septic shoulder. Pt presented after several ER and PMD visits with c/o severe R shoulder pain.  Pt had pain immediately after injection with worsening pain, swelling into the fingers, and inability to lift arm and close fist. PE (+) for R deltoid swelling and erythema, decreased ROM.  Shoulder was tapped following presence of joint effusion on US and placed on abx. Dramatic improvement by POD#1.					Y	5			Y	10/06/2008	10/06/2008	0	Labs and Diagnostics:  US of R shoulder (+) for joint effusion. Synovial fluid with 86,033 neutrophils, 90% polys. Cx (-). Shoulder X-ray WNL. CBC with WBC 11.1.	OTH	PVT	TOPROL XL; LIPITOR; CELEBREX		Hypertension and some shortness of breath. PMH: HTN.  Hypercholesterolemia.			1						1	Debridement; Injected limb mobility decreased; Joint effusion; Joint irrigation; Joint swelling; Musculoskeletal pain; Oedema peripheral; Purulence; White blood cell count	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89884~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0988F~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0330985	10/31/2008	KY	64.0	64		F	10/30/2008	Itching in both arms 2pm 10/28/08.  Hives by 9:00 PM 10/28/08.  Pt. saw dermatologist 4: w 10/28/08; prescribed topical steroid;  Pt called MD at 9:00 PM 10/28/08: prescribed oral steroid.									N	10/28/2008	10/28/2008	0		OTH	OTH	Unknown					1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2B09AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330987	10/31/2008	AK	22.0	22		M	10/10/2008	Got Flu/pneu shot 10/8/08, one day later 10/9/08- redness, pain, warm to touch, felt hot & cold for 2 days, nausea, 10 cm of erythema that is swollen, hot touch and red.  Utlrasound showed no abscess- gave SXT for 7 days.				Y					Y	10/08/2008	10/09/2008	1		PVT	OTH		Viral meningitis				1						1	Erythema; Feeling of body temperature change; Nausea; Pain; Skin warm; Swelling; Ultrasound scan normal	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0330988	10/31/2008	MA	54.0	54		F	10/31/2008	This was pt 1st flu vaccine.  She c/o itching at injection site L Deltoid.  There was no redness or swelling- just itch-  The itching was intermittent but lessening- still present as of 10/30/08 evening.									U	10/23/2008	10/23/2008	0	None	PUB	PUB	DETROL LA	None	PENICILLIN;  AMOXICILLIN; SULFA			1						1	Injection site pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8997A~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330989	10/31/2008	TX	11.0	11		M	10/31/2008	Rash to ABD & face 20 min after inj.  30 min. after rash appeared man gave BENADRYL apx. 3 tap.  Last night pt felt warm to touch.  Pt with c/o of nausea-dizziness + vomit.  Rash subsided 15 min after BENADRYL given.  Pt still has rash this AM again BENADRYL given- Pt ok.									Y	10/30/2008	10/30/2008	0	No test done	PVT	PUB		Dizziness;  LLQ Pain	Wasp & fire ants hypersensitivity			1						1	Dizziness; Nausea; Rash; Skin warm; Vomiting	FLU3~SANOFI PASTEUR~U2789BA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2549AA~1~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B020AA~1~UN~UN~TDAP (BOOSTRIX)~1	USA		Influenza
0330991	10/31/2008	NJ	65.0	65		F	10/28/2008	10/25/08- 10pm redness & warm at injection site R arm, pain at site when lying on R side. 10/26/08 redness moved to inside of arm 5x5 area.  10/27/08 seen by MD dermatologist- Rx given for Z Pak (AZITHROMYCIN x 5 days) 10/30/08- area faded & almost gone.				Y					Y	10/25/2008	10/25/2008	0		PUB	PUB	ASA 81 mg;  SIMVASTATIN 40 mg;  ZYRTEC - OTC; GLUCOSAMINE SULFATE	No	Allergic to PENICILLIN	chicken pox~Zoster (Zostavax)~1~64.00~In Patient		1						1	Erythema; Injection site erythema; Injection site pain; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA181AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1132U~2~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0330992	10/31/2008	KS	30.0	30		F	10/31/2008	Pt reported hives and dizziness approximately 1500pm on 10/30/08 after receiving vaccine on 10/30/08 AM. Took Benadryl by mouth and Benadryl cream to hives. Symptoms improved in approximately 30 minutes.									Y	10/30/2008	10/30/2008	0	NONE	OTH	OTH	Benadryl PO and Topical	0	Ceclor Allergy			1						1	Dizziness; Urticaria	FLU3~SANOFI PASTEUR~U2808AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330993	10/31/2008	OH	45.0	45		F	10/29/2008	L upper arm swollen, reddened after patchy non-raised rash.  Painful arm. L forearm and L side feels like a stiff neck.  Has headache.  Received VACC.  on 10/27- no problem.  Sore arm on 10/28.  More painful on 10/29 and also involving neck + forearm, plus rash + swelling, headache.  On 10/30/08 had generalized malaise, chills, fatigue.  L Deltoid, trapezius sore + HA present.  Still has neck + trapezius muscular stiffness + pain and also headache as of 10/31/08.  Taking PREDNISONE dose pack and BENADRYL.  Physician dx'd localized allergic reaction.				Y					Y	10/27/2008	10/29/2008	2	None	PUB	OTH	ZOLOFT 200 mg Q daily;  Pepcid 20 mg daily	None	Cervical Cellular dysplasia;  Oyster + crablegs caused rash + itchiness to palms + soles of feet			1						1	Chills; Erythema; Fatigue; Headache; Hypersensitivity; Malaise; Musculoskeletal stiffness; Oedema peripheral; Pain in extremity; Rash; Back pain; Chills; Erythema; Fatigue; Flushing; Headache; Hypersensitivity; Injection site haematoma; Injection site pain; Injection site swelling; Malaise; Musculoskeletal stiffness; Myalgia; Neck pain; Pain in extremity; Rash	FLU3~CSL LIMITED~02649111A~3~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|FLU3~CSL LIMITED~02649111A~3~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~2	USA	Emergency room visit	Influenza
0330996	10/31/2008	FL	68.0	68		M	11/01/2008	Patient was given a flu shot.  Immunized & unsure if the syringe was filled with FLUVIRIN or air (0.5 ml)									Y	10/29/2008	10/29/2008	0		OTH	OTH		None	None			1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~87989~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330997	10/31/2008	MI	76.0	76		M	10/31/2008	Injection site swelling and pain									N	10/29/2008	10/30/2008	1	None	OTH	PVT	None	None	None			1						1	Injection site pain; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~2~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1382U~2~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330998	10/31/2008	TN	56.0	56		F	11/01/2008	Severly sore arm, could not raise arm for approx. 3 days.  When laying down there is no comfortable position even when laying on opposite side.  IBUPROFEN, NAPROXEN sod.  did not help.  Also complained of sharp pains + tenderness.									N	10/24/2008	10/24/2008	0		OTH	PVT	SYNTHROID	None/Healthy	None			1						1	Injected limb mobility decreased; Pain; Pain in extremity; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881136P~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331004	10/31/2008	TX	45.0	45		F	10/31/2008	Received Influenza vaccine (IM) 10/9/2008 at about 1530 hrs; was well day of and prior to vaccination. Within 40 minutes following immunization, felt extreme drowsiness while driving her car, fell asleep at the wheel, resulting in MVA. She was not injured in accident. Went home, took 4 hr nap and awoke about 2030 hrs feeling fine. No other associated systemic symptoms, no local injection site reactions; no prior vaccine-associated reactions; no meds; no significant past medical history reported. Was not seen by medical provider for evaluation. Symptoms: Lethargic.									Y	10/09/2008	10/09/2008	0	None	MIL	MIL	None					1						1	Lethargy; Road traffic accident; Somnolence	FLU3~CSL LIMITED~CSL01649111A~UNK~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0331006	10/31/2008	GA	62.0	62		F	10/31/2008	Pt received vaccine on 10-30-08 @ 830 am called on 10/31/08 9 am states had lower abdominal pain with lower back pain with chest tightness with 99.2 fever @ 230 pm the same day. Feels better today. Does not need to go to ER or do not feel need to follow up. Stated will call if any problems.									Y	10/30/2008	10/30/2008	0		OTH	OTH	Estrogen Patch, Pepcid AC, Tylenol PRN		Takes estrogen patch, Pt allergic to PCN, Cyclor, and Tetracycline			1						1	Abdominal pain lower; Back pain; Chest discomfort; Pyrexia	FLU3~SANOFI PASTEUR~U2831AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331009	10/31/2008	WI	47.0	47		F	10/29/2008	States had a mild reaction following the flu vaccine; within 15 minutes after receiving noted tickle in throat, pre asthma symptoms. Denied any SOB or chest pain. C/O dry throat and had end expiration dry cough. Took over the counter Benadryl and used Albuterol MDI. Symptoms gone 1-2 hours.									Y	10/27/2008	10/27/2008	0		PUB	PVT	Unknown	None	Unknown - Has prescription MDI Albuterol PRN			1						1	Asthma; Cough; Dry throat; Throat irritation	FLU3~SANOFI PASTEUR~U2770AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331010	10/31/2008	WI	46.0	46		F	10/30/2008	Had flu shot.  Approx 1-2 hours later, I developed dry hacky persistent cough.  My chest grew tight.  The cough increased in intensity & frequency.  As I was leaving, I felt my throat closing & my tongue grew numb.  My lips began to tingle & my eyes turned bright red.  I went to ER.  They listened to my chest and placed pulse ox on me.  my stats were in the 80's.  They placed a nasal canula in my face & started an IV of NaCl (I think).  They left it wide open & gave SOLUMEDROL, PEPCID & BENADRYL via IV.  Shortly, after I felt my chest opening & my throat wasn't as irritated.  After reassessment, they let me leave and placed me on PREDNOSONE (5mg)  X 3d.  B10.  It took about 10 days to completely overcome the symptoms.  I followed up w/ my doctor & he suggested / see an allergist.									Y	10/15/2008	10/15/2008	0	They drew a bunch of labs.  Have not seen results.	PUB	UNK		None	Allergy= PCN;  ROCEPHIN;  E-MYCIN; Iodine; Mold			1						1	Chest discomfort; Cough; Hypoaesthesia oral; Laboratory test; Ocular hyperaemia; Oxygen saturation decreased; Paraesthesia oral; Throat tightness	FLU3~SANOFI PASTEUR~U2770AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331011	10/31/2008	SC	1.3	1	.3	M	10/31/2008	Vomited X 1 in office.  Temp 105 in office } 10/29/08.  Vomited X2 10/28/08.  3 loose non-bloody stools 10/28/08.				Y					Y	10/28/2008	10/29/2008	1	MD visit- see or note	PVT	UNK	None	stuffy nose	Esotropia -> dx as pseudocirabisimus			1						1	Body temperature increased; Diarrhoea; Vomiting	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B085AA~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2B28AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB618AA~3~IM~LL~HEP B (ENGERIX-B)~1|HIBV~SANOFI PASTEUR~UF505AA~3~IM~RL~HIB (ACTHIB)~1	USA	Emergency room visit	Influenza
0331012	10/31/2008	WI	45.0	45		F	10/29/2008	States approximately two hours after receiving flu vaccine noted fever, chills, seizing chest pain, horrible sore throat, headache, conjunctivitis, muscle aches, nausea and conjunctivitis. Went to clinic for eval. Symptoms subsided within 12 hours except conjunctivitis.				Y					Y	10/22/2008	10/22/2008	0		PVT	PVT	Unknown	None	Unknown			1						1	Chest pain; Chills; Conjunctivitis; Headache; Myalgia; Nausea; Oropharyngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U2755AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331013	10/31/2008	NJ	71.0	71		F	10/31/2008	Patient came in reporting painful swelling of right upper arm since 10/29 evening. She took Advil every 4 hours and used ice and it has not gotten better. It is currently red, hot and swollen. Mostly inner arm from below elbow to tender axilla. Temp 98.4 at 1:20 pm. Referred to urgent care for evaluation and treatment.									U	10/29/2008	10/29/2008	0		PVT	PUB		None				1						1	Axillary pain; Erythema; Oedema peripheral; Pain in extremity; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA166AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0619X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331014	10/31/2008	KY	45.0	45		F	10/30/2008	Brachial Plexus Neuritis - pain in left arm - shoulder to elbow. Started 2 hours after injection.				Y					N	10/03/2008	10/03/2008	0	None	OTH	PVT	NEXIUM, ZEGERID	None	Seasonal allergies			1						1	Brachial plexopathy; Pain in extremity; Radiculitis brachial	FLUX~UNKNOWN MANUFACTURER~AFLLA157AA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0331018	10/31/2008	TX	65.0	65		F	10/31/2008	During the middle of the night (after immunization was given). Pt became dizzy/lightheaded and nauseous. She also developed a rash on her arm in which the pneumovax was given. The rash is on her left arm from shoulder to elbow.									U	10/29/2008	10/29/2008	0		OTH	PVT		None	seasonal allergies			1						1	Dizziness; Injection site rash; Nausea; Rash	FLU3~SANOFI PASTEUR~U2761AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1381U~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331019	10/31/2008	CA	1.3	1	.3	F	10/30/2008	Redness and swelling at injection site L thigh. Keflex 125 mg tid x 10 days									U	10/28/2008	10/28/2008	0		PVT	PVT		None	None			1						1	Injection site erythema; Injection site swelling	DTAP~SANOFI PASTEUR~C2956BA~4~UN~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2785AA~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF464AA~4~UN~RL~HIB (ACTHIB)~1	USA		Influenza
0331020	10/31/2008	KY	31.0	31		F	10/31/2008	Approx 1 1/2 weeks after vaccination started with L shoulder/arm pain. Prednisone started 10/17/08 - completed 10/28/08. Pain better while on Prednisone, but resumed pain 10/31/08.				Y					N	10/03/2008	10/15/2008	12	None	OTH	PVT	Lialda, Claritin	None	Ulcerative colitis, asthma			1						1	Musculoskeletal pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~AFLLA157AA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0331023	10/31/2008	WA	4.0	4		M	10/31/2008	Pt was here for influenza vaccine, given DTAP that was intended for sibling at the same visit. 10/28 pt was here for Influenza vaccine, given DTAP that was intended for sibling at the same visit. 10/29-phone call to mother, child had stomach ache no vomiting no fever. 10/30-phone call to mom-fever last night, tactile, resolved this AM.									Y	10/28/2008	10/29/2008	1	None	PVT	PUB		None	None			1						1	Wrong drug administered	DTAP~SANOFI PASTEUR~C2955BA~6~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2763AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331024	10/31/2008	MI	5.0	5		M	10/31/2008	Left arm from shoulder red and swollen on 10/26/08 per mother. Redness and swelling decreased on 10/27/08 to about the size of an orange.									Y	10/25/2008	10/26/2008	1		PVT	PVT		None		~Influenza (Seasonal) (no brand name)~4~4.00~In Patient		1						1	Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~U2832AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330953	11/01/2008	MN	61.0	61		M	10/31/2008	Congestion, fever, red, burning eyes, constriction in throat				Y					Y	10/30/2008	10/30/2008	0		UNK	UNK		None	None			1						1	Eye irritation; Ocular hyperaemia; Pyrexia; Respiratory tract congestion; Throat tightness	FLU3~SANOFI PASTEUR~U2807AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330955	11/01/2008		5.0	5		F	11/01/2008	Pain and itching at injection site followed by severe swelling. ER doctors prescribed antihistimines and Motrin.				Y					U	10/31/2008	11/01/2008	1	allergic reaction	MIL	UNK	none	none				1						1	Hypersensitivity; Injection site pain; Injection site pruritus; Injection site swelling	FLU3~SANOFI PASTEUR~U2506AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330957	11/01/2008	TX	73.0	73		M	11/01/2008	Patient given a flu shot in right arm and a pneumonia shot in his left arm on 10/29/08.  Wife called and stated patient had swelling and extreme soreness in left arm.  Follow up call on 11/1/2008, patient no longer has soreness and did not require any further medical care.									Y	10/29/2008	10/29/2008	0		UNK	PVT		none	none			1						1	Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~u2761aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1381u~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330958	11/01/2008	TN	66.0	65		M	11/01/2008	Patient reported that he he had flu-like symptoms after receiving the vaccine.  He stated that he had body aches and chills to the point that he was unable to get out of bed for 1 week after receiving vaccine.									Y	10/10/2008	10/11/2008	1		UNK	PVT						1						1	Activities of daily living impaired; Chills; Influenza like illness; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88113 4P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330959	11/01/2008	TN	64.0	64		F	11/01/2008	Pt complained of hives which manifested from her armpits to her hairline.  She stated these began within 24 hours of receiving vaccine.  She visited a walk-in clinic and received a steroid shot; the hives resolved shortly after the injection.									Y	10/15/2008	10/17/2008	2		UNK	PVT						1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88113 4p~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0330960	11/01/2008	PA	69.0	69		F	11/01/2008	Oct.15th got flu shot. Oct 16th experienced weakness, fever, cough, sore throat, headache, really bad chills, muscle ache, fatigue. October 18 - 19 fever was 102. Mucus. Sneezing. As of Nov 1., no fever, but still weak.				Y					U	10/15/2008	10/16/2008	1		PVT	PUB	Lipitor 20 mgs	None	None			1						1	Asthenia; Chills; Cough; Fatigue; Headache; Myalgia; Oropharyngeal pain; Pyrexia; Rhinorrhoea; Sneezing	FLU3~SANOFI PASTEUR~U2748aa~2~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330961	11/01/2008	CA	20.0	20		F	11/01/2008	(1215) Approximately 5 minutes after recieving flu vaccination client appearing flushed,with c/o dizziness, nausea, tightening of chest; V/S taken 147/83 P 100 RR 26-28 911 Call activiated and Epinephrine 1:1000 1 mg SC (R) UE; Notified supervisor, area health officer and family;(1217) Paramedics to scene; Relative arrived;(1250) Transported to Hospital via paramedic transport.				Y					U	11/01/2008	11/01/2008	0	N/A	UNK	UNK	Denies taking any medications	c/o cough x 1 day and denies fever	Denies			1						1	Chest discomfort; Dizziness; Flushing; Immediate post-injection reaction; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0330964	11/02/2008	SC	53.0	53		M	11/02/2008	Fever in one day, so far has lasted 4 days.									U	10/29/2008	10/30/2008	1		UNK	UNK	Lipitor, Diovan, Metaform	None	None			1						1	Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330965	11/02/2008	IN	30.0	30		F	11/02/2008	First week = Flu like Sx, Fever, muscle ache, tired(lasting about a week or so). While still on a Z-Pack, I developed Bell's Palsey. It was detected early and treated with steroids, therefore lasting only about 1 month. Exact Date of flu shot and Dx of Bells palsey are not known. Middle of Oct = flu shot, Middle of Nov. = Bells Palsey Dx.  11/11/08 Reviewed ENT medical records of 11/28-12/07/20007. FINAL DX: Bell's palsy Records reveal patient experienced right side tongue numbness, decreased taste, right facial & mouth weakness.  Exam revealed unable to completely close right eye, right facial weakness.  Tx w/steroids & artificial tears.									Y	10/13/2007	11/13/2007	31		UNK	UNK	none	none	none			1						1	Facial palsy; Fatigue; Influenza like illness; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330968	11/02/2008	CO	28.0	28		F	11/02/2008	On October 22, 2008 I got the Influenza Vaccine at approximately 10:30 am. Around 1:30 I started feeling dizzy and cloudy. By 3:00 pm I was feeling sore and shaky and around 4 pm I started getting very cold. I was freezing and no matter how many blankets I wrapped around myself I was still cold. My temperature spiked to 103.7 and I was still freezing and unable to move. I couldn't breath and my tongue felt odd.  By 6:30 I was unable to walk at all, my husband threw me in a cold shower and brought my temperature down at which time I took allergy pills and Tylenol and my temperature fell down to 99.9, but it kept spiking up to 101 to 103 for another 30-45 minutes at which point my temperature stabilized and I was able to move around again. I believe it was an allergic reaction as the next day I was completely fine.									Y	10/22/2008	10/22/2008	0		PVT	PVT		None	None			1						1	Body temperature increased; Dizziness; Dyspnoea; Feeling abnormal; Feeling cold; Gait disturbance; Pain; Paraesthesia oral; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330969	11/02/2008	NY	68.0	68		F	11/02/2008	Chiils, total body aches, fever 102.4 within 9 hours of administration									Y	10/23/2008				PUB	UNK			Hypertension, Hyperlipidemia			1						1	Chills; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2750AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330990	11/02/2008	FL	20.0	20		M	11/02/2008	Pt felt lighthead c/o nausea.  Slightly pale in color @ 11:20am.  LOC, start feeling better after (one(11:28).  No treatment given.  No fainting occurred, no vomiting.  BP 103/58 + Sx 11:25am.				Y					Y	11/02/2008	11/02/2008	0	None	MIL	MIL	None	None	None			1						1	Dizziness; Pallor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA168AA~5~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB251BA~3~UN~LA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0330994	11/02/2008	NY	53.0	53		M	11/01/2008	SQ ANTHRAX #1 given to L deltoid became flushed + fainted c/o had EPIPHEN administered.  B/P 148  P 80 R 22.				Y					Y	11/01/2008	11/01/2008	0		MIL	MIL	None	None	None			1						1	Flushing; Syncope	ANTH~EMERGENT BIOSOLUTIONS~FAV149~1~SC~UN~ANTHRAX (BIOTHRAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA168AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB640AA~1~IM~UN~HEP B (ENGERIX-B)~1|TYP~SANOFI PASTEUR~B03472~1~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0329847	11/03/2008	IL	7.0	7		F	10/23/2008	A serious, spontaneous report of idiopathic thrombocytopenia purpura (ITP) was received from a nurse concerning a seven-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST, intranasal, on 25-Aug-2008. On 21-Sep-2008, the patient was admitted to the hospital with a diagnosis of idiopathic thrombocytopenia purpura. The patient is still undergoing treatment with intravenous immunoglobulin and platelet counts have ranged between 4,000 and 26,000. The parent was told by specialists that ITP is caused by virus and per the parent the only known virus before ITP was live FLUMIST. The event is considered on-going.					Y	0			N	08/25/2008	09/21/2008	27	Unknown dates, Platelet Count, 4,000-26,000	PVT	PVT	Concomitant Drug(s) Not Reported				MEDI0007341	1						2	Idiopathic thrombocytopenic purpura; Platelet count decreased; Blood product transfusion; Idiopathic thrombocytopenic purpura; Platelet count decreased	FLUN3~MEDIMMUNE VACCINES, INC.~500543P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500543P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Hospitalisation	Influenza
0330148	11/03/2008		0.8	0	.8	U		Pt received vaccine for flu on 10/20/08 at approximately 11:00 AM. Pt died at approximately 6:00 am on 10/21/08.	Y	10/21/2008							N	10/20/2008	10/21/2008	1		UNK	UNK						1						2	Death; Laboratory test; Death	FLU3~SANOFI PASTEUR~UA2828AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2828AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0331000	11/03/2008	IN	72.0	72		M		Pt was confused, weak legs had fever, dehydrated, sweating, couldn't talk, MD Rx chemotherapy and LUPRON shots for Pt, possible flu, or infection				Y					Y	10/30/2008	10/31/2008	1		OTH	PUB		Possibly respiratory infection	Cancer			1						1	Aphasia; Asthenia; Confusional state; Dehydration; Hyperhidrosis; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~81884~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0551X~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331003	11/03/2008	CT				F		Bell's palsy  (Pt is also 28 weeks pregnant)									U	10/27/2008	10/28/2008	1	None	PUB	PVT	Prenatal MVT	None	Pregnant - 28 weeks			1						1	Drug exposure during pregnancy; Facial palsy	FLU3~SANOFI PASTEUR~02349111A~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331017	11/03/2008	CA	3.0	3		M	10/31/2008	Patient develop T 100'F tired and headache X 2-3d				Y					Y	10/23/2008	10/23/2008	0		PVT	PVT		None	None			1						1	Fatigue; Headache; Pyrexia	FLU3~SANOFI PASTEUR~U2792AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB282AA~UNK~UN~UN~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0331021	11/03/2008	MI	4.0	4		F	10/29/2008	4:32 PM 10/29/08 - Dad called , his daughter slipped off her chair at preschool onto floor and had a seizure did recover and is alert.  Dad is 15 min away - will pick her up and take her to Pediatric ER- 911 nurse called PRN				Y					Y	10/29/2008	10/29/2008	0	Per ER	PVT	PVT	None	None	None			1						1	Convulsion	FLU3~SANOFI PASTEUR~U2832AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331030	11/03/2008	MI	40.0			F	11/03/2008	Generalized Erythematous pruritic rash on arms, legs, torso.									Y	10/22/2008	10/23/2008	1		PVT	PVT	None	None	None			1						1	Rash erythematous; Rash pruritic	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AF1HA3648A~1~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331041	11/03/2008	TN	62.0	62		M	11/03/2008	Several days experienced fatigue. Not feeling well. Tuesday night - sensation of flutter in throat and chest. Got better. Wed. night - flutter sensation and felt heart beat. Diagnosed w/ atrial fibrillation. IV Heparin. Converted on the 30th, started on COUMADIN.  12/15/2008 ER records received for DOS 10/29-30/2008 with DX: Atrial Fibrillation with rapid ventricular rate.  Hypokalemia. Pt presented with c/o irregular heartbeats and chest discomfort. PE (+) for irregularly irregular heartbeat. Admitted for medication mgmt.					Y	2			Y	10/22/2008	10/29/2008	7	Blood work; EKG; CXR; echocardiogram; scan . Labs and Diagnsotics: Echo (+) for mild concentric hypertrophy and diastolic dysfunction.  Stress test WNL. CT heart (+) for calcified granuloma with calcified mediastinal lymph nodes. CXR WNL. PT 41.7 on admission down to 23.4.  INR 4.31 on admission down to 2.34.  CBC with WBCs 10.3, Hgb 15.8. K+ 3.0. Cl- 95.  T4 low at 5.6	PUB	PUB	Steroid injection for chronic sinusitis 10/3/08; HTN; Cholesterol.	No	NKDA; dust mites. PMH: HTN, Acid reflux, ulcer, appendectomy, laminectomy, cataract removal			1						1	Atrial fibrillation; Chest discomfort; Fatigue; Malaise; Throat irritation	FLU3~SANOFI PASTEUR~U2768AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0331042	11/03/2008	LA	58.0	58		M	10/30/2008	Patient had the flu vaccine on 10/23/08 and was admitted to the hospital on 10/25/08 with bleeding on the brain though the patient was on medication COUMADIN which is a blood thinner. Patient had called with questions about if his symptoms could be a reaction to the flu vaccine, his symptoms were headache, vomited twice last night and feeling achy. The correct dose and route of the flu vaccine was given. patient was given the information sheet and consent to read about the flu vaccine prior to the injection.  1/23/09 MR received fro multiple admissions 10/26-11/14/2008 with DX: Large chronic subdural hematoma, 11/14-12/1/2008 with DX: Poor neurological status due to bilateral subdural hematoma and 12/1-3/2008 with D/C DX: Chronic bilaterally subdural hematomas with poor neurologic recovery. Initially presented following a seizure preceeded by 2 day hx of H/A. Subdural hematomas noted on CT and taken emergently to OR for evacuation. Pt in guarded condition, intubated with decreased LOC following procedure. Unresponsive and posturing, reflexes depressed.Was to be d/c to palliative care 11/14/08, but began to awaken and was speaking albeit confused, lasted only briefly. Little improvement from 11/14/-12/1/08 so transferred to trasitional care unit. Developed Acute Renal Failure. D/C to hospice care.			Y		Y	37			U	10/23/2008	10/25/2008	2	Labs and Diagnostics:  CT scan (+) for bilateral subdural hematomas, later (+) for infarcts. CPK 339. CKMB 6.1, %MB 1.7-WNL.EEG abnormal	UNK	UNK			Patient on medication COUMADIN for Atrial fib, DM type II, OSA, HTN, High Cholesterol; Allergies: Neosporin, Bactrim, Avandamet, PCN. Has had the flu vaccine before with no reaction. PMH:  Factor V Leiden deficiency. Diabetes, atrial fibrillation-on Coumadin, hyperlipidemia, and hernia repair.  allergies to Bacitracin, Neosporin, and PCN			1						1	Anticoagulant therapy; Haemorrhage intracranial; Headache; Pain; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88910~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0331043	11/03/2008	CA	66.0	66		F	10/27/2008	3 hours after FLUVAX: developed dyspnea, cough, conjunctivitis, rhinitis, ST so came to doctor's office. When in office, became hypotensive. Dx:anaphylaxis and treated with IM BENADRYL and Epinephrine. Ambulance pt to hospital and given IV TAGAMET and recovered.  11/7/08 Reviewed ER medical records of 10/22/2008. FINAL DX: acute allergic reaction; conjunctivitis Records reveal patient experienced eye discomfort & swelling, heat, chest tightness, cough & jaw discomfort approx 2 hours s/p vaccination.  RTC & tx w/epi, IM benadryl.  BP at that time 80/50 & transported to ER.  Improving by the time arrived in ER.  Exam in ER revealed dramatic swelling & crusting of eyes, scleral injection, tongue cramping.  Pulse ox initially was 91% & BP supine 130/76, standing 106 systolic.  No reaction to previous flu shots.			Y	Y					Y	10/22/2008	10/22/2008	0		PVT	PVT		None	High cholesterol; Sleep apnea; Allergic rhinitis; osteopenia  Allergy: codeine.			1						1	Anaphylactic reaction; Conjunctivitis; Cough; Dyspnoea; Hypotension; Rhinitis	FLU3~SANOFI PASTEUR~U2793EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0331044	11/03/2008	NH	25.0	25		F	10/29/2008	Unconscious; Hearing loss; leg paralyzed. 12/15/08-records received for DOS 10/21-10/26/08-DC DX:Adrenal insufficiencey. Infections, complications, affecting treatment/stay. Migraines. Admitted with hypotensive status and respiratory rate of 3. Echo 55%, hypotension and heart failure improved. Most likely cause of hypotension was benzo or opioid overdose or central adrenal insufficience possibly 2/2 opioids or less likely steroid use during nasal septum surgery. Developed LE weakness question of muscle swelling vs other polyneuropathy.  Gradual improvement in ability to weight bear. Right sided hearing loss acutely unclear cause now improving. Follow-up: See attached letter, found daughter unconscious loss use of hearing and legs 10/20/08 7:30AM brought to hospital ICU. I am the mother of patient whose letter is dated November 23, 2008. I also had the same flu shot Influenza Brand Name: FLUARIX, Manufacturer, Glaxo-Smith Kline, AFLUA375AA Exp. 6/30/09. Since this shot I also have had pain on the top of my foot - nothing of the magnitude of patient's problem, but I thought it important to let you know. We are hoping for a response to this problem. Please find enclosed information you requested Influenza Brand Name: FLUARIX, Manufacturer, Glaxo-Smith Kline. AFLUA375AA Exp. 6/30/09. This vaccine was given to my daughter on 10/14/08 and on 10/20/08 the following occurred: she was found by me unconscious and unresponsive. She lost the use of her legs and hearing. She was at hospital ICU for 1 day and transferred until 10/26/08. During her stay at the hospital, she encountered migraine headaches the entire time. The doctors she saw were general, endocrinologist, neurologists, and orthopedic surgeon. They have not come to a definite conclusion as to why she passed out originally and hit her head and why was her entire body was effected such as blood pressure, sugar, liver, heart, etc. I feel there is a possibility the shot could of caused this problem. She has regained her hearing but her right leg and foot has severe nerve damage and is very very painful. She has physical distress and is unable to do anything. She cannot drive, walk well, eat, go to work, and ride her horse (no activities). She remains in bed all day except to go out for physical therapy. She has now lost her job, which took her a year to find after getting out of college. Her wages biweekly were $1077.00. She now she has to pay Cobra at the cost of $645.00 per month. This is a financial burden to me because my husband has Parkinson's disease for over 28 years and is in a day care during the day...she was helping me take of him and now she can no longer do so. I would appreciate a response to this situation as soon as possible.				Y	Y	7	Y		N	10/14/2008	10/20/2008	6	Many tests performed at hospital. 12/15/08-records received-Peroneal nerve palsy on right and thigh swelling with marked myositis and fat stranding on CT. Troponin peak 1.07. Elevated trasnaminases. CXR-tiny pleural effusion bibasilar atelectasis. MRI leptomeningeal enhancement. Echocardiogram 55%	PUB	PVT			12/15/08-records received-PMH:Migraines.Multiple medications, depression, anxiety.			1						1	Activities of daily living impaired; Cardiac failure; Deafness unilateral; Gait disturbance; Head injury; Impaired driving ability; Impaired work ability; Intensive care; Loss of consciousness; Loss of consciousness; Loss of employment; Monoplegia; Muscular weakness; Nerve injury; Pain in extremity; Unresponsive to stimuli	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA375AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0331045	11/03/2008	OH	69.0	69		F	10/21/2008	Arm felt heavy prior to leaving drug store but did not report to clinic worsening sx, joint pains, cramping, terrible headache, BP elevated, 102 temp, skin red and burning, eyes red and burning. Had shocky feeling. Ativan given in ER. After Ativan didn't feel 100% better until today. Weak feeling all over. Gave Rx Xanax, last night diarrhea but only once - feels 100% better today. 11/4/08-ED records received for DOS 10/15/08-presented with C/O tightness like band in chest since day before, shaking onset today, nausea, shortness of breath, dizziness and cough. Headache. Upper back and neck pain. Pedal edema.			Y	Y					Y	10/15/2008	10/15/2008	0	CT; U/S lungs and legs; Chest X-ray; ABG; Routine bloodwork - no abnormalities visualized. 11/4/08-records received- Blood culture no growth.	OTH	PVT	IOPROL XL 25mg, 1/1 BID; HCTZ 25 mg, 1/2 tab  Sun to Wed; LANOXIN 25 MCG, 1/1 qd; SIMIVESTIN 20 mg, 1/1 qd; COUMADIN 5mg alternate 1/1 for 2 days - 1 1/2 for 1/1 day; SYNTHROID 125 MCG, 1/1 tab qd X 6 days +tab Sun; OSCAl + D 1/1 qd; One da	None 11/4/08-records received-Diagnosed with Pneumonia 2 weeks ago.	Penicillin - Tetracycline - KEFLEX- PERCOCET- CIPRO- EPPI + NOREPPI- CLARIDON. All cough syrups - Histamines - No Aspirin or Aspirin Products. 11/4/08-records received-PMH: hypertension, hyperlipidemia,  atrial fibrillation, GERD, asthma, COPD.			1						1	Arthralgia; Asthenia; Blood gases normal; Blood pressure increased; Blood test normal; Body temperature increased; Chest X-ray normal; Computerised tomogram normal; Diarrhoea; Erythema; Eye irritation; Feeling abnormal; Generalised erythema; Headache; Muscle spasms; Ocular hyperaemia; Paraesthesia; Sensation of heaviness; Skin burning sensation; Ultrasound scan normal	FLU3~SANOFI PASTEUR~U2831AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0331046	11/03/2008	PA	83.0	83		F	10/31/2008	Lost all hearing ability in right ear (same side as injection) 24 hrs. after. Treated by a ENT Specialist on Oct 15 and 29. He prescribed Medrol 4mg (21-pack) on Oct 29th.11/4/08-records received for 10/6/08 routine exam.				Y				Y	N	10/06/2008	10/07/2008	1	MRI of brain with and without contrast. 12/10/08-12/10/08 MRI report received for DOS 10/17/08-moderate white matter disease in bilateral pons consistent with age ischemic changes. 10/15/08-hearing test-severe to profound hearing loss AD. AS mild to moderate severe hearing loss.	PVT	UNK	Metoprolol; amlodipine besylate 25 BID; SYNTHROID 125mcg; WARFARIN 4 & 5 mg	None	Hypertension; Atrial fib.; allergy to penicillin; Thiazide diuretics			1						1	Deafness unilateral; Nuclear magnetic resonance imaging brain	FLU3~SANOFI PASTEUR~U2787EA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0331047	11/03/2008	KY	14.0	14		F	10/28/2008	Pt to Nurse office at 1:50 with hives on BL Upper arms. Pt states the hives are itching. Pt c/o back itching also. Pt given BENADRYL 50 mg PO - By 2:40 hives gone itching gone				Y					Y	10/27/2008	10/27/2008	0		OTH	OTH	Unknown	Unknown				1						1	Pruritus; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500558P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0331048	11/03/2008	MD	49.0	49		F	10/27/2008	Erythema induration 5x8 cm diam noted 24 hours after injection. Pt noted little itching also Px reported to health unit 48 hour after administration of vaccine, Diphenhydramine and KEFLEX given									U	10/22/2008	10/23/2008	1	None	OTH	OTH	Blood Pressure; Thyroid	None	None			1						1	Erythema; Induration; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA159AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331049	11/03/2008	MA	4.0	4		M	10/28/2008	Received flu shot yesterday c/o increase fever >104 degrees F. headache, sore throat. Flu test shown (+) A & B									U	10/28/2008	10/28/2008	0	Flu test (+) A (+) B (Rapid Test)	PUB	PUB	None	None	None			1						1	Headache; Influenza serology positive; Oropharyngeal pain; Pyrexia	DTAP~SANOFI PASTEUR~U246uCA~6~UN~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2766AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0831~UNK~UN~UN~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0331050	11/03/2008	IL	32.0	32		F	10/29/2008	Headache, nausea, swelling of entire arm all within 45 minutes. Patient used ice on injection site and Benadryl 25mg.									Y	10/28/2008	10/28/2008	0		PUB	PVT	Insulin; Singulair; Benicar; Zyrtec; MVI		Diabetes; Asthma; HTN; Allergies (Seasonal)			1						1	Headache; Nausea; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331054	11/03/2008	MI	61.0	61		F	10/29/2008	Pt stated later  in eve. after shots her right arm was red, tight, and warm to touch. Appeared to have red bord around arm about 2 below injection site went to urgent care - Given ATARAX and CIPRO				Y					Y	10/23/2008	10/26/2008	3	Per Urgent Care Cellulitis right arm	OTH	PVT	None	None	None			1						1	Cellulitis; Erythema; Induration; Skin warm	FLU3~SANOFI PASTEUR~U2570AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0200U~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331055	11/03/2008	MI	65.0	65		F	10/29/2008	Pt states around 1830-1900 she began shaking and was very chilled, throat started to swell and she had diff. breathing . She states she took 2 TYLENOL and within an hour felt better. No c/o cough or tongue swelling. States she did have headache.									Y	10/23/2008	10/23/2008	0	None	OTH	PUB	ACTIVELLA; LESCOL	None	Hyperlipidemia; Osteopenia.			1						1	Chills; Dyspnoea; Headache; Pharyngeal oedema; Tremor	FLU3~SANOFI PASTEUR~U2750AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331056	11/03/2008	MI	52.0	52		F	10/29/2008	Pats states while driving home she began coughing. cough grad. deepened in chest. By the time she arrived home (1730) Pt took her  BP 87/124 drove herself to ER. States by now shaking, throat on fire and tongue swelling, ER did EKG and sent her home. Dr: allergic reaction - very congested at bedtime. Felt fine in AM									Y	10/20/2008	10/20/2008	0	Allergic reaction	OTH	PVT	;     ; Lisinopril; DARVOCET; Lovastatin  ASA	None	Per pt increase BP; increase cholesterol			1						1	Cough; Hypersensitivity; Swollen tongue; Throat irritation; Tremor; Upper respiratory tract congestion	FLU3~SANOFI PASTEUR~U2750AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331059	11/03/2008	OH	1.9	1	.9	M	10/29/2008	Patient developed fever 103 at 800 am 10/25/08. Vomited 10/25/08 and  10/26/08 and once 10/28/08. Fever also present up to 103 on 10/26/08. Patient was given 0.5ml dose instead of 0.25ml.									Y	10/24/2008	10/25/2008	1	None	PVT	PVT	None except Multi Vitamin C Fluorit	None	Reactive Airway Disease at 3 months			1						1	Incorrect dose administered; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~42789BA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331060	11/03/2008	OH	6.0	6		F	10/31/2008	10-27-08 Physical - Had cough 10-28-08 Rash mother stated she had 2 areas on her back yesterday. Now spread to arms, legs, head and face.				Y					Y	10/27/2008	10/27/2008	0	CBC-SMAC, total iron, ferritin, ASOT, EBV, Streptozyme, Mycoplasma GTOS, Monospot, T-4 TSH, CPK, Lead.	PVT	PUB	Delsym	Cough	None Known			1						1	Blood creatine phosphokinase; Blood lead; Blood thyroid stimulating hormone; Cough; Epstein-Barr virus test; Full blood count; Mycoplasma serology; Rash; Thyroxine	FLU3~SANOFI PASTEUR~U2839AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB257AA~1~IM~LA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0331061	11/03/2008	NH	22.0	22		F	10/30/2008	At 9:00 PM started with rash (hives).  Very itchy.  Some difficulty breathing, relieved with Albuterol inhaler.  Took Benadryl at 9:30 AM with effect.  Patient reports some discomfort in right arm.  Advised to take Zyrtec if symptoms persist.  Hives on right arm.									Y	10/24/2008	10/24/2008	0		PVT	PVT			Asthma			1						1	Dyspnoea; Limb discomfort; Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U2769AA~5~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB251BA~2~UN~RA~HEP A (HAVRIX)~1	USA		Influenza
0331063	11/03/2008	IL	64.0	64		M	10/29/2008	20 days ago had flu shot. 3rd day after shot started with itchy legs & swelling in thighs. States he gained 10lbs in a few days. Within a week still some mild itching to both lower extremities.				Y					Y	10/09/2008	10/21/2008	12		MIL	UNK						1						1	Oedema peripheral; Pruritus; Weight increased	FLU3~SANOFI PASTEUR~U2745AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331065	11/03/2008	CA	62.0	62		F		Generalized, pruritic rash.				Y					U	10/20/2008	10/20/2008	0	None	PVT	PVT	Fosamax; Atenolol; Ca; MV	None	Codeine, & iodine containing compounds			1						1	Rash pruritic	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA174AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0331068	11/03/2008	OR	57.0	57		M	10/24/2008	around 10pm had hot and cold chills felt like he was getting the flu throwing up, unsteady gait, confused lasted until 3-4am went to sleep at 6am started to feel better  weak, dehydrated, sleeping off and on all day									Y	10/22/2008	10/22/2008	0		PUB	PVT	MIRALEX;  Carotote Kedrin;  MEGACE;  Fentenyl patch; MS CONTIN	Osteoporosis, Chronic pain, Malnutrition	No allergies		OR200836	1						1	Asthenia; Chills; Confusional state; Dehydration; Feeling hot; Gait disturbance; Influenza like illness; Vomiting	FLU3~SANOFI PASTEUR~U2768AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331069	11/03/2008	FL	61.0	61		F	10/30/2008	(R) arm cellulite and lymphoedema S/P, PNEUMOVAX Vaccination.				Y					U	10/29/2008	10/30/2008	1	Visit with Dr and CBC Pnto (lab) antibiotics	PVT	OTH		None	None			1						1	Cellulitis; Full blood count; Lymphoedema	FLU3~SANOFI PASTEUR~U2740AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0813X~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331070	11/03/2008	IN	57.0	57		F	10/27/2008	Increased Temp 104>106 - Lethargy, extreme muscle ache, nausea - Ill X 3 days.									Y	10/14/2008	10/15/2008	1	None	UNK	UNK		None	None			1						1	Body temperature increased; Lethargy; Malaise; Myalgia; Nausea	FLU3~CSL LIMITED~AFLLA165AA~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0331071	11/03/2008	MO	25.0	25		M	10/23/2008	Visual disturbance, nausea, cold chills, dizzy. He took Benadryl and Tylenol later that evening.									Y	10/22/2008	10/22/2008	0	BP normal; Pulse 115; temp 100.2F	OTH	PVT	None	None	None			1						1	Chills; Dizziness; Nausea; Visual impairment	FLU3~CSL LIMITED~03549111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0331072	11/03/2008	NV	37.0	37		M	10/22/2008	Received flu shot and within 5 minutes had rash.  dry mouth and headache.				Y					Y	10/11/2008	10/11/2008	0		PVT	PVT	None	None	None			1						1	Dry mouth; Headache; Immediate post-injection reaction; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA366CA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0331073	11/03/2008	IL	25.0	25		F	10/27/2008	Patient c/o chest tightness and difficulty breathing at 1200. She was pale and diaphoretic, pulse 118. Sent to facility. Returned to work adverse reaction not found by facility.				Y					Y	10/24/2008	10/24/2008	0		OTH	PVT		No	No			1						1	Chest discomfort; Dyspnoea; Heart rate; Hyperhidrosis; Pallor; Chest discomfort; Dyspnoea; Heart rate increased; Hyperhidrosis; Hypersensitivity; Pallor	FLU3~CSL LIMITED~03549111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|FLU3~CSL LIMITED~03549111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~2	USA	Emergency room visit	Influenza
0331074	11/03/2008	PA	30.0	30		F	10/23/2008	Several hours after receiving FLUZONE she experienced airway swelling, tight chest, chest pin and difficulty breathing.  She also had a low grade, fever, chills, rapid heart rate, coughing, runny nose, and slight nose bleed.  Pt. took antihistamine and famotadine.  She did not seek medical help.									Y	10/21/2008	10/21/2008	0	None	OTH	PUB		None	None			1						1	Chest discomfort; Chest pain; Chills; Cough; Dyspnoea; Epistaxis; Heart rate increased; Laryngotracheal oedema; Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~U2764AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331075	11/03/2008	MN	7.0	7		F	10/27/2008	Patient has developed hives all over her body which are still persisting.									N	10/15/2008	10/23/2008	8	None	PVT	PVT	None	None	No known allergies or conditions			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2759AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331076	11/03/2008	CA	71.0	71		F	10/28/2008	Initial itching on right Deltoid/injection site. Pt developed Erythema multiforme within Sun 10/27/08										10/23/2008	10/23/2008	0		PVT	PVT	ALEVE	None				1						1	Erythema multiforme; Injection site pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA169AA~7+~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331077	11/03/2008	MN	29.0	29		F	10/27/2008	First time recipient of flu shot. Employee monitored for 15 mins after vaccine - an appeared to be O.K - but anxious about the wait and possible side effects. Employee  returned to see nurse 60 min  later, extremely anxious - I think  I am having a reaction: Increase BP and pulse, c/o extreme (R) arm wrist pain - within visible  thumb print like  bruise noted. (R) ear red and itchy - and  8 small redden spots visible on her throat. Breathing rate increase, lung clear. C/o tingling and itchy all over				Y					Y	10/15/2008	10/15/2008	0	SpO2- 99%	OTH	OTH	None	None	None Known			1						1	Anxiety; Arthralgia; Blood pressure increased; Contusion; Erythema; Heart rate increased; Paraesthesia; Pharyngeal erythema; Pruritus generalised; Respiratory rate increased	FLU3~SANOFI PASTEUR~U2758AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331078	11/03/2008	WA	45.0	45		F		Shortly after receiving PNEUMOVAX  (on left arm) soreness developed. 24 hours after receiving PNEUMOVAX (on left arm) & FLUARIX (one right arm): fatigue, loss of appetite, headache developed, body aches developed and worsened as time progressed, tightness in chest cavity, sudden chills throughout sleep, hives developed around where PNEUMOVAX was received and arm extremely sore with very limited movement ability due to pain. 48 hours after receiving PNEUMOVAX and FLUARIX: fatigue, loss of appetite, headache, body aches, tightness in chest cavity, hives stayed around where PNEUMOVAX was received and arm extremely sore with very limited movement ability due to pain. Hives felt hard and warm to touch. 72 hours after receiving PNEUMOVAX and FLUARIX: fatigue, hives persisted and arm extremely sore with very limited movement ability due to pain. Ibuprofen was taken the first 72 hours. Heat pad had only accelerated hives and soreness. Symptoms continuing									U	10/22/2008	10/23/2008	1		OTH	OTH	Birth control pills ENPRESSE		Allergic to Amoxicillin			1						1	Anorexia; Chest discomfort; Chills; Fatigue; Headache; Injected limb mobility decreased; Injection site urticaria; Pain; Pain in extremity; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~65K~1~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1035F~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331079	11/03/2008	OH	46.0	46		F	10/20/2008	Fever, nausea, aches.									Y	10/14/2008	10/15/2008	1		PUB	UNK		None	None			1						1	Nausea; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88635~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331080	11/03/2008	TX	50.0	50		F	11/03/2008	Rash to arms, neck, and back. No blistering or weeping. Pt has appt. with PV. MD										10/29/2008	10/30/2008	1	None patient has appt with PV and MD	PUB	UNK	Lisinopril  (BIP)	None	High Bld pressure			1						1	Rash	FLU3~SANOFI PASTEUR~U2798BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331082	11/03/2008	TX	65.0	65		F	10/30/2008	Patient came in complaining of reaction. Had what appeared to be cellulitis on inner left arm (upper).									U	10/28/2008	10/28/2008	0		UNK	UNK						1						1	Cellulitis	FLU3~SANOFI PASTEUR~U2741AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1541U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331083	11/03/2008	VA	2.0	2	.6	F	10/30/2008	Prolonged fever 10/22 - 10/30 without some anemia, elevated ESR and irritability									U	10/21/2008	10/22/2008	1	WBC, Satellite 4.2; RBC, Satellite 3.67; Hemoglobin, Satellite, 9.9, L, Hematocrit, Satel  28.6 VL; MCV, Satellite 77.9 L; MCH, Satellite 27.0; MCHC, Satellite 34.6 H; RDW, Satellite 16.0; Platelet, Satellite 173; SED Rate 58 HE	PVT	UNK	OMNICEF 250 mg 3/4 tip qd	Resolving URI	Gastroesophageal reflux disease			1						1	Haematocrit decreased; Haemoglobin decreased; Irritability; Mean cell haemoglobin concentration increased; Mean cell haemoglobin normal; Mean cell volume abnormal; Pyrexia; Red blood cell count normal; Red blood cell sedimentation rate increased; White blood cell count normal	FLUN3~MEDIMMUNE VACCINES, INC.~500543P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0331084	11/03/2008	CA	68.0	68		F	11/03/2008	Vax given 10/30/08 - 24 hours later became very ill with heavy breathing, heaviness, head ache and sore arm. Next morning had stomach upset, chills, and sweat. Pt still has sore arm. Took ibuprofen									Y	10/30/2008	10/31/2008	1		PUB	UNK	Calcium		Breast cancer			1						1	Chills; Headache; Hyperhidrosis; Hyperventilation; Pain in extremity; Sensation of heaviness; Stomach discomfort	FLUX~UNKNOWN MANUFACTURER~A~UNK~SC~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~X~UNK~UN~LL~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0331086	11/03/2008	CT	22.0	22		F	11/03/2008	Rash on hands and elbows - (R) (L)									U	10/06/2008	11/03/2008	28	None	MIL	MIL		None	None			1						1	Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197AA~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|SMALL~EMERGENT BIOSOLUTIONS~VV04003A~1~OT~LA~SMALLPOX (ACAM2000)~1	USA		Influenza
0331087	11/03/2008	IL	1.7	1	.7	M	11/03/2008	Tues 10/24/08 PLN @ 4 with warm that night, 101 in them,  103 late night. Sat AM (10/18 - better) Sat 5p-104.3 ? febrile seizure or delirium starting @ a light fever went to ER  BLO WK, ER Dr did complete exam , 10/21 developed a rash and following Tuesday a week later Pt fever going away. Has not had any further adverse events.				Y					Y	10/17/2008	10/18/2008	1	None	PVT	PVT	None	None	None			1						1	Delirium; Febrile convulsion; Feeling hot; Laboratory test; Pyrexia; Rash	FLU3~SANOFI PASTEUR~UT2785AA~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331090	11/03/2008	MO	24.0	24		F	11/03/2008	On 10-30-08 client woke up with a headache, she took ASA and it went away. Also had headaches on 11-1-08 and 11-2-08 and took ASA and it went away. On 11-1-08 client states her rib area is very sore and still very  sore today. She thinks it is due to flu shot because it is he first flu shot									U	10/29/2008	10/30/2008	1	None	PUB	PVT	None	None	None			1						1	Headache; Musculoskeletal chest pain	FLU3~SANOFI PASTEUR~U2768AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331091	11/03/2008	NV	67.0	67		F	11/03/2008	Right arm, could not move, in pain, redness from below shoulder to elbow.  Next day, 10/30 went back to pharmacy seen by PA who recommended waldryl pill.  Still could not move arm went back to pharmacy on 10/31.  Pharmacist was to report adverse event.  Decided to go to place.  Seen by Dr who prescribed AZITHROMYCIN and CETIRIZINE for skin infection; gave patient arm sling.  Today condition has improved  99%.				Y					Y	10/29/2008	10/29/2008	0		OTH	PUB	EVISTA;  FOSOMAX; Centrum vitamins;  Multimineral;  Fish oil;  Flaxseed; GLUCOSAMINE;  NIACIN	No	Osteoporosis			1						1	Erythema; Injected limb mobility decreased; Pain in extremity; Skin infection	FLUX~UNKNOWN MANUFACTURER~~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~UN~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0331093	11/03/2008	AZ				F	10/28/2008	Began having bad chills and body aches around 8:30 pm - fell asleep, woke up and checked fever and was 101.1.  Body ached so bad it felt like my legs were gonna fall off.  Took 4 Ibuprofen and 2 hrs later woke up from my heart pounding out of my chest.  Felt like I was burning up - took temperature again and was 101.5.  Heart rate was 144 bpm - went to ER, received fluids and Ativan.				Y					Y	10/24/2008	10/24/2008	0		PVT	PVT	Metformin	None	Poly cystic ovary syndrome			1						1	Chills; Feeling hot; Pain; Palpitations; Pyrexia	FLU3~SANOFI PASTEUR~U2740AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331094	11/03/2008	PA	0.18	0	.2	M	10/27/2008	Flu shot (1/2 dose) was given to a 2 month old.									U	10/27/2008	10/27/2008	0		PVT	MIL			None			1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~UZ839AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331095	11/03/2008	MI	42.0	42		F	10/29/2008	Localized allergic reaction, raised red, itchy, firm to touch, size of tennis ball. Very sore to touch. Began to subside after 24hrs. Still itchy today.									Y	10/27/2008	10/27/2008	0		PVT	PVT	PAXIL; LIPITOR; FLORINEFF	No	Ragweed Allergy			1						1	Erythema; Hypersensitivity; Induration; Local reaction; Pain; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U2763AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331096	11/03/2008	PA	52.0	52		F	10/28/2008	Employee states since receiving flu shot has been experiencing severe pain, unable to lift arm above head- denies it became red, swollen or knotted at area of injection.				Y					N	10/16/2008	10/16/2008	0		OTH	OTH		None	None			1						1	Injected limb mobility decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA159AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0331097	11/03/2008	IL	45.0	45		M	10/28/2008	Erythematous, blanching patches across chest, abdomen, and pelvis.  Treatment: Medrol dose pack.										10/14/2008	10/26/2008	12		OTH	UNK			Penicillin			1						1	Erythema; Pallor	FLUX~UNKNOWN MANUFACTURER~~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331098	11/03/2008	GA	63.0	63		F	10/16/2008	Macular type red rash on upper torso (back & front)- measle type rash-itching-saw Dermatologist-he could not make a diagnosis either.									N	10/09/2008	10/10/2008	1	None	PUB	PUB	DM, HTN  Lasix-10-20 mg Tenormin-25 mg Diovan Hct 160/12.5 Indocin 5r 75 mg Colchicine 0.6 mg  Synthroid .25 mg Lexapro 20 mg Wellbutrin XL 150 mg  Glucovance 5/500-2 daily  Prilosec  Geritol Complete Glucosamine w/condroitin Ambien	None	None			1						1	Pruritus; Rash erythematous; Rash macular; Rash morbilliform	FLU3~SANOFI PASTEUR~U2769AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331099	11/03/2008	MD	86.0	86		F	10/27/2008	Onset of rash and hives early am 10/24 over total body.  Very pruritic.  Vitals satisfactory.  No associated symptoms.  T/C to PCP midday 10/24.  Tx' D  with BENADRYL 25mg with little/ no relief.  ER 7pm 10/25.  Tx'D with steroid injection and PO MEDROL pack.  Slowly improving.				Y						10/22/2008	10/24/2008	2	None	PUB	PUB	GABAPENTIN;  NASONEX;  LORAZEPAM;  AMITRIPTYLIN;  EFFEXOR XR;  FEXOFENADINE;  OMEPRAZOLE;  METOPROLOL;  TYLENOL;  CYANOCOBACAL;  Citracal Calcium Citrate;  Folic Acid;  Geritol complete multivitamin;  NEBULIZER	None	Seasonal allergies;  anxiety; depression; GERD;  Hypertension;  Osteoarthritis; B12;  FOLATE;  M-VIT;  Pulmicort; N Nebulizer;  ALBUTEROL			1						1	Rash generalised; Rash pruritic; Urticaria	FLU3~SANOFI PASTEUR~U2811AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331101	11/03/2008	MS	49.0	49		M	10/05/2008	Increased T, itching, whelps entire body, tightness in chest, swelling of hands. Tx with IM injection & PO med.				Y					Y	10/04/2008	10/04/2008	0		MIL	MIL				Yes~Influenza (Seasonal) (no brand name)~1~36.00~Patient		1						1	Body temperature increased; Chest discomfort; Oedema peripheral; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~50060P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0331113	11/03/2008	MO	57.0	57		F	10/24/2008	Pt. woke up during night with painful arm. This a.m. 10/24/08 arm very sore decreased R.O.M. Red/swollen area 11 cm wide x 16 1/2 cm in length				Y					U	10/23/2008	10/23/2008	0	Sent pt for ultrasound to R/O Hematoma-it was Negative for hematoma.	PVT	PVT		None	CAD, COPD, Pacemaker, hyperlipidemia			1						1	Erythema; Joint range of motion decreased; Oedema peripheral; Pain in extremity; Ultrasound scan normal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLL9181AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0551X~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331117	11/03/2008	GA	1.67	1	.7	F	11/03/2008	Vomiting, Diarrhea, high fever 103.5, lethargic, not eating, drinking very little.  Not playful.				Y					Y	10/31/2008	10/31/2008	0	N/A	PVT	PUB	Singulair 4mg (once per day)	None.  Child healthy.	Child takes singulair for asthma/allergy type symptoms.			1						1	Decreased activity; Diarrhoea; Hypophagia; Lethargy; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~unknown~2~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0331118	11/03/2008	IA	2.0	2	.8	M	11/03/2008	Got shot at 1:15pm, threw up at 4:30pm, 5pm, 5:45pm, 6:45pm, and 7:45pm.  Also had low grade fever for about 24 hrs.									Y	10/31/2008	10/31/2008	0	digital thermometer, axillary temp of 100 deg.	PVT	PVT	Daily multivitamin	None	None	none~ ()~NULL~~In Patient		1						1	Body temperature increased; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331120	11/03/2008	MI	1.0	1	.0	F	11/03/2008	Patient was given Varicella vaccination on 10/23/08.  Mom states she began acting fussy last night and brought her in for scheduled visit today.  Temperature 98.5 orally at visit today. Patient has scattered lesions (30-35) over anterior trunk, groin, and bilateral lower extremities.  Mom did not notice lesions until patient was undressed at OV today.									N	10/23/2008	11/02/2008	10	None performed	PVT	PUB	Amoxicillin given by Emergency Department	Seen earlier in week at ER and given Amoxicillin for OM, no infection present in bilateral ears at office visit on 10/23/08	None known			1						1	Body temperature; Irritability; Rash; Skin lesion	FLU3~SANOFI PASTEUR~U2764AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0981X~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C99080~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1185X~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0331121	11/03/2008	MN	60.0	60		F	11/03/2008	Patient developed headache and nausea approximately 30 minutes after receiving the influenza vaccine. Symptoms continued until that night. All symptoms were resolved by the next morning.									Y	10/27/2008	10/27/2008	0	none	PUB	PUB		None	None			1						1	Headache; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFluA367CA~3~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331123	11/03/2008	NJ	48.0	48		F	11/03/2008	Started itching of scalp, spread to entrie body, palm of hands and sole of foot more intense.  Noticed hives and redness 4-5 hours after receinvg vaccine.									N	10/30/2008	10/30/2008	0	continue to itch after 5 days treatment with oral benadryl and hydrocortizine ointment.	PUB	PVT	Metformin, Benacor	no	diabetes, Hypertension			1						1	Erythema; Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua350ca~3~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331125	11/03/2008	OK	4.0	4		M	11/03/2008	Mother reports quarter size redened area at injection site the evening of flu vaccine administration.  Reports child was irritable and fussy.  No reported fever until 10/30/08.  Redness and swelling continued and was seen by local physician on 10/31/08 with fever 101 with Tylenol.  Redness reported from shoulder to elbow.  Physician started benadryl 4time per day.				Y					Y	10/29/2008	10/30/2008	1		PUB	PUB	None	NO				1						1	Injection site erythema; Injection site swelling; Irritability; Pyrexia	FLU3~SANOFI PASTEUR~u2829aa~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331126	11/03/2008	MN	45.0	45		F	11/03/2008	Thick tongue, eyes itchy then matted shut, face swollen, hard to talk, achiness, nausea, vomiting, chills, coughing - difficult to clear throat. Swelling in face resolved in 2 days.  No redness, swelling or pain at site of injection. Did not seek medical treatment - no health insurance.  Did call a nurse information line & was told it is not vaccine related.									Y	10/29/2008	10/29/2008	0		PUB	PVT	None	None	PCN allergy, otherwise none			1						1	Chills; Cough; Eye discharge; Eye pruritus; Nausea; Pain; Speech disorder; Swelling face; Throat irritation; Tongue disorder; Vomiting	FLU3~SANOFI PASTEUR~U2770AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331127	11/03/2008	GA	37.0	37		M	11/03/2008	Shot administered in patient's right shoulder above bi-cep. Patient experienced significant pain at the site of injection. Patient also developed a swelling, discolored red skin, and sensitivity to touch from the site of injection extending down the arm and around the inner bicep. Symptoms lasted 6 days and was treated with ibuprofin.									Y	10/28/2008	10/29/2008	1	N/A	UNK	PVT	N/A	N/A	N/A	N/A~ ()~NULL~~In Patient		1						1	Hyperaesthesia; Injection site erythema; Injection site pain; Injection site swelling	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1|PNC~PFIZER\WYETH~~UNK~~~PNEUMO (PREVNAR)~1	USA		Influenza
0331128	11/03/2008	NJ	4.0	4		F	11/03/2008	Seen in our office on 10/28/08 for 4 year WCU.  Recieved Dtap, MMr, FLu, IPOL, and Varivax.  Woke up on 10/31/08 with left upper arm swellung, red and indurated.  Seen in our office and prescibed Augmentin.				Y					Y	10/28/2008	10/31/2008	3	N/A	PVT	PVT	Amoxicillian	Left Otitis Media				1						1	Injection site erythema; Injection site induration; Injection site swelling	DTAP~SANOFI PASTEUR~c2999AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2765AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A1229~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~404X/1084X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0996X/4067X~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0331131	11/03/2008	PA	30.0	30		F	11/03/2008	Employee called ~30 minutes after receiving fluzone to report that she felt itchy all over and face felt hot. Upon examination of employee, this RN observed no blotching or rash despite employee's need to scratch. Her face appeared flush. Her breathing was WNL without distress. Benadryl 25mg PO was administered immediately and EE remained under observation for 30 minutes with improvement of symptoms. At that time she drove home and stopped at her Allergist's office, who treated her with Prednisone taper, Zyrtec & Xopenex inhaler. The next day 10/21/08 she went home from work early not feeling well with respiratory complaints. On 10/22/08, while at work, she felt SOB. Dr. went to her desk to examine her. VSS, 130/92, 76. O2 mask applied. BS clear, no stridor. BP lowered to 130/80. Upon consultation with her Allergist, EE sent to local ER.				Y					Y	10/20/2008	10/20/2008	0	none	UNK	UNK	Inderal, Nexium, Zyrtec, Imipramine	none	Asthma; Allergic to PCN, Sulfa, Ceclor, Mushrooms, Artificial Crab Meat			1						1	Activities of daily living impaired; Dyspnoea; Feeling hot; Flushing; Heart rate normal; Oxygen supplementation; Pruritus generalised; Respiratory disorder	FLU3~SANOFI PASTEUR~U2847AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331132	11/03/2008	VA	2.0	2	.2	F	11/03/2008	High fever, site swelling and redness progressively increasing in size; very sick				Y						10/30/2008	10/30/2008	0	Put on antibiotic day after, received Rocephin IM at hospital 2 days after injection	PVT	UNK		none	none			1						1	Injection site erythema; Injection site swelling; Malaise; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~~RL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331133	11/03/2008	KY	61.0	61		F	11/03/2008	Pt reported flu like symptoms, chills, dizziness, nausea, headache and back ache within 4 hours of receiving the vaccination.  Pt called pharmacy and was told to get some tylenol for the bach aches and the headache.  Pt called the pharmacy the second time and was told to contact her physician.  Pt did go to ER the night of the vaccination for the symptoms previously reported.				Y					N	10/31/2008	10/31/2008	0		UNK	PVT	Levothyroxine, Estradiol, Hydrochlorothiazide, Meloxicam, Gabapentin, Actonel	None	None			1						1	Back pain; Chills; Dizziness; Headache; Influenza like illness; Nausea	FLU3~CSL LIMITED~02349111A~UNK~IM~~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0331134	11/03/2008	VA	5.0	5		M	11/03/2008	Site swelling/redness; fever; sister with symptoms more severe.				Y						10/30/2008	10/31/2008	1	Antibiotic prescribed 2 days after shot	UNK	UNK	Singulair	None	None	severe local reaction, high fever~Pneumo (Pneumovax)~~2.20~Sibling|severe local reaction, high fever~Influenza (Seasonal) (no br		1						1	Injection site erythema; Injection site swelling; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331135	11/03/2008	WA	38.0	38		F	11/03/2008	within 5 hours, individual became symptomatic with congestion, cough, chest tight.  At 72 hours, reported significant congestion, cough, aches, fever. On day 5, was admitted en the evening through ED with severe dehydration, malaise, myalgia, flu symptoms.   Recieved pain medication, IV fluids, anti-emetics after pain medicine.  Remained in hospital observation for two days. 11/4/08-records received for DOS 10/30-10/31/08-DC DX: Influenza-like illness, secondary to vaccine reaction. Presented to ED 5 hours after receipt of vaccine with C/O generalized myalgias, cough, pleuritic chest pain, malaise and headache. Received hydration overnight and discharged.				Y	Y	1			Y	10/24/2008	10/24/2008	0	No diagnostic testing.	UNK	UNK		None	Ankylosing Spondylosis 11/4/08-records received-PMH: Fibromyalgia. Ankylosing spondylitis, HLA-B27 positive. Gastroparesis. Depression. Mitral vale prolapse. Anomalous coronaries. Pancreatitis in 2000.			1						1	Cough; Dehydration; Malaise; Myalgia; Pain; Pyrexia; Respiratory tract congestion	FLUN3~MEDIMMUNE VACCINES, INC.~50047P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0331137	11/03/2008	VA	51.0	51		F	11/03/2008	Pneumovax given in Left Deltoid on 10-17-08.  Pt's husband states that patient developed redness swelling tenderness and low grade fever 48 hours after the vaccination in the left arm.  States that a prescription was called in for Keflex by him (husband is a physician) and the patient made a full recovery.									Y	10/17/2008	10/19/2008	2	None	UNK	UNK	None	None	Meniere's disease, has cochlear implant put in 6 years ago.			1						1	Injection site erythema; Injection site pain; Injection site swelling; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA168AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0619X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331139	11/03/2008	SD	10.0	10		F	11/03/2008	Recieved phone call from clients mother at 10:30 this morning.  Mother stated that child had recieved flu shot at flu clinic on 10/29/08.  Later that evening she noted red hives developing, she did not give her anything at that time but in the morning she was red all over and had all over.  Mother has been giving patient Benadryl about every 5 hours and she did go to school today.  States maybe she didn't need any Benadryl but I did give her some before she went to school.  Mother had spoke with friends of hers about the reaction and they advised her to keep giving the Benadryl until syptoms had gone away and that she needed to let us know this so a report could be completed.  This is the first time patient had recieved the flu vaccination and does not have any allergies to eggs.									Y	10/29/2008	10/29/2008	0		UNK	UNK						1						1	Erythema; Urticaria	FLU3~SANOFI PASTEUR~U2811AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331141	11/03/2008	UT	46.0	46		F	11/03/2008	Patient descibed reaction as low grade fever, muscle aches and fatigue lasting around 24 - 48 hours.									Y	10/27/2008	10/28/2008	1	none	UNK	PVT	unknown	Unknown	Unknown			1						1	Fatigue; Myalgia; Pyrexia	FLU3~CSL LIMITED~01349111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0331143	11/03/2008	FL	51.0	51		F	11/03/2008	Apprx 0.5 mm  L postauricularlymphadenpathy, swolllen L deltoid, pt c/o pain when move head to L, denies; fever, difficulty chewing/swallowing or decreased ROM of arm. Instructed pt to continue ibuprofen 400 mg every 6-8 hours with warm compress, report to PCP if unresolved in 48 hours or ER if drooling, high fever, difficulty chewing/swallowing or neck pain.									U	11/02/2008	11/03/2008	1		UNK	UNK		None reported				1						1	Lymphadenopathy; Oedema peripheral; Pain	FLU3~SANOFI PASTEUR~U2771AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331144	11/03/2008	MN	55.0	55		F	11/03/2008	Left shuolder frozen shoulder, throbbing when laying down at night.  Flu vaccination on Friday & Saturday evening shoulder became sore.									N	10/31/2008	11/01/2008	1		PUB	PVT	none	none	none			1						1	Pain; Periarthritis	FLU3~SANOFI PASTEUR~U2770AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331146	11/03/2008	MO	7.0	7		F	11/03/2008	Patient received immunizations and immediately began coughing, developed cyanosis, severe respiratory distress, and oral and facial edema. Oxygen sats at first assessment 55-60 percent, BP 120/90, HR 160. Was alert and able to talk with difficulty. Lung fields decreased aeration bilaterally. Oxygen cannula and Albuterol nebulization administered. Epi pen applied (lot 7EM841, exp 07/09). Pt responded immediately, pulse ox increased to 100%. Patient transferred to ER by ambulance.  11/11/2008 MR received for ER visit 10/22/08 with DX:  Allergic Reaction-serum, anaphylactic shock. Immediately after receiving vax pt began coughing, became SOB, fell to the ground and turned blue. TX with epipen and nebs and transferred to ER via EMS. Upon arrival in ER sx had resolved.				Y	Y	1			Y	10/22/2008	10/22/2008	0		UNK	UNK		None; patient had been diagnosed in 09/18/08 with right ear infection, recurrent pneumonia and cough; was started on Albuterol HFA prn and immune work up normal.Had completed antibiotic therapy.				1						1	Breath sounds abnormal; Cough; Cyanosis; Face oedema; Immediate post-injection reaction; Oxygen saturation decreased; Oxygen supplementation; Respiratory distress	FLU3~SANOFI PASTEUR~U2805AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1679U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0331147	11/03/2008	CA	36.0	36		F	11/03/2008	Patient states that approx. 3 hrs. after vaccine,suffered from shortness of breath, palpitations, cough. Went to nearby walk-in clinic. States she received a breathing treatment that alleviated her symptoms.				Y					Y	10/23/2008	10/23/2008	0	Patient stated none were done.	UNK	UNK	Patient denies being on any meds.	Patient denies having any illness.	Patient denies.			1						1	Cough; Dyspnoea; Palpitations	FLU3~SANOFI PASTEUR~U2744AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331148	11/03/2008	IL	10.0	10		M	11/03/2008	About 3 minutes after giving flu immunization, patient complained of being light-headed and fainted. Very diaphoretic and weak.  Ambulance called and sent to Hospital where he was diagnosed as a fainting spell and sent home.  Back to work the following day. Dr. did not feel it was an allergic reaction to the flu immunization.				Y					Y	10/30/2008	10/30/2008	0		UNK	UNK						1						1	Asthenia; Dizziness; Hyperhidrosis; Syncope	FLU3~SANOFI PASTEUR~U2743AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331149	11/03/2008	GA	72.0	72		F	11/03/2008	Zostavax was the vaccine given, it is not in the list of vaccines below. Patient stated she was very off balance the next morning.  She stayed in bed all day Thursday.  Friday, Sat., and Sunday she was off balance  Used a cane to help her get around.  Pt. did not feel like it was vertigo.  She said she staggered around.  By Monday she was better and has not reported any more problems									Y	10/08/2008	10/09/2008	1	none	UNK	UNK	Benicar, Atenolol, Aspirin, Nasonex	none				1						1	Activities of daily living impaired; Balance disorder; Gait disturbance	FLU3~SANOFI PASTEUR~U2810AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~1206X~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0331150	11/03/2008	CA	47.0	47		F	11/03/2008	SORE THROAT WITH EAR PAIN, FEVERISH & CHILLS ON&OFF, EYES HURT, DIZZY, TIRED, CONGESTION, HAY FEVER SNEEZING, HEADACHES, SHORTNESS OF BREATH, CHEST PAINS, BODY ACHES...LASTED OVER A WEEK...STAYED IN BED ON DAY 3 & 4(SUNDAY...PLANNED ON ER VISIT ON MONDAY, IF COULD NOT GET OUT OF BED), TIRENESS, SORE THROAT, & SNEEZING LINGERED TO DAY 10-11 OF DAY OF FLUMIST.									U	10/22/2008	10/22/2008	0	SORE THOAT/EAR PAIN/ NASAL DRIP ALMOST IMMEDIATE. 10/23/08 SORE THROAT/EAR/START OF NASAL CONGESTION W/HEADACHE, EYES WATERY & HURT-BURNING, SOME DIZZYNESS...2-3 TIMES I FELT LIKE THE ONSET OF A FEVER FOLLOWED BY CHILLS...10/24/08 NASAL CONGESTION W/HEADACHE WORSEN, FEVER & CHILLS, TIRENESS, EYES BURNING FEELING, DIZZY...10/25/08 NASAL CONGESTION, HEADACHE SEVERE, HORSE VOICE, TIRED, UNSTOPPABLE SNEEZING AT TIMES....RESTED AND WAS ASLEEP BY 7:30PM..10/26/08 FULL BLOWN CONGESTION, VOICE NOT RECOGNIZABLE, EXTREME SNEEZING, EXTREME TIRENESS,EYES HURT, DIZZNESS, SHORTNESS OF BREATH, & CHEST PAINS..VERY PALE...IF NOT A SUNDAY, WOULD BE AT ER. 10/27/08...WEAK, SYPTOMS GOING AWAY...SORE THROAT & EYES SEEMED TO LINGER AND HAVE HAY FEVER TYPE SNEEZING TO NOW.	UNK	PUB		NONE	BASIC ALLERGIES TO ANIMAL HAIRS, USE TO TAKE ALLERGY INJECTIONS. STOPPED INJECTIONS OVER 15 YEARS AGO...OTHERWISE HEALTHY CONDITION			1						1	Chest pain; Chills; Dizziness; Dysphonia; Dyspnoea; Ear pain; Eye irritation; Eye pain; Fatigue; Headache; Lacrimation increased; Nasal congestion; Oropharyngeal pain; Pain; Pallor; Pyrexia; Respiratory tract congestion; Seasonal allergy; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~B/FLORIDA/4/200~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0331151	11/03/2008	KY	10.0	10		M	11/03/2008	PATIENT HAS HIVES, PALENESS, WEAKNESS, DIZZINESS.  i TOOK PATIENT TO EMERG. ROOM ON 10-26-08.  sTEROID SHOT AND STEROIDS GIVEN.  TOOK PATIENT TO FAMILY DR ON 10-27-08 TOLD TO DOUBLE STEROIDS AND WAS GIVEN STEROID CREAM.  MY SON IS NO BETTER! HIVES ARE, BUT HE PASSED OUT AT SCHOOL TODAY 11-03-2008! oUR DR. WOULD NOT SEEM HIM DUE TO OUR NEW INSUR COVERAGE!  iM OUT RAGED AND WORRIED ABOUT MY SON!				Y					N	10/24/2008	10/25/2008	1		UNK	UNK	NONE	NONE	PREMATURE,	~Influenza (Seasonal) (FluMist)~1~0.00~In Patient		1						1	Activities of daily living impaired; Asthenia; Dizziness; Loss of consciousness; Pallor; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~1~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0331152	11/03/2008	SC	55.0	55		F	10/29/2008	Got flu vaccine 10/28/08 @ 3pm.  Around 5 pm, felt nauseated; around 7:30 felt achy all over, especially shoulders and back.  Then had chills and shakiness, vomited 5-6 times. that evening.  Weak but much better next day did not go to physician.									Y	10/28/2008	10/28/2008	0	none	PUB	PUB	none	none	none		SC0813	1						1	Asthenia; Chills; Nausea; Pain; Tremor; Vomiting	FLU3~SANOFI PASTEUR~U2828A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331153	11/03/2008	DE	4.0	4		F	11/03/2008	The child developed a generalized, itching rash on 11/2/08 at night.  Vaccines given on 10/31/08.									U	10/31/2008	11/02/2008	2		PUB	PUB		None				1						1	Rash generalised; Rash pruritic	FLUN3~MEDIMMUNE VACCINES, INC.~50055OP~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~AO805~4~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1926U~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1904U~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0331154	11/03/2008	MN	49.0	49		F	11/03/2008	Presented to ED approximately 4 hours after vaccination reporting throat tightness, chest heaviness, and red itchy eyes. She was given 4mg Decadron and 50mg Diphenhydramine IM. Slight improvement in ER. Sent home with prednisone.				Y					Y	11/03/2008	11/03/2008	0		PUB	UNK	OCP		None. Patient states allergic to ecchinacea with similar symptoms.			1						1	Chest discomfort; Eye pruritus; Ocular hyperaemia; Throat tightness	FLU3~SANOFI PASTEUR~U2810AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331157	11/03/2008	OR	45.0	45		F	11/03/2008	This case was reported by a healthcare professional and described the occurrence of lymphadenopathy in a 45-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject's medical history included allergy to SUPRAX, allergy to ZITHROMAX, environmental allergy and penicillin allergy. With the exception of the influenza virus vaccine, the subject had no adverse events following receipt of other previous immunizations. Concurrent medications included Oral contraceptives, NASACORT, XYZAL and Allergy shot. The subject received no other vaccinations on the date of receipt of FLUARIX. On an unspecified date in 2007, the subject received unspecified dose of Influenza vaccine (unknown). On an unspecified date in 2007, less than one year after vaccination with Influenza vaccine, the subject experienced lymphadenopathy. The lymphadenopathy resolved after eight days. On 28 October 2008 between 5:00 p.m. and 5:30 p.m., the subject received unspecified dose of FLUARIX (.5 ml, unknown, right arm). On the morning of 29 October 2008, 1 day after vaccination with FLUARIX, the subject experienced lymphadenopathy, erythema, lymph node palpable and lymph node tenderness. The healthcare professional considered the events that occurred on 29 October 2008 were clinically significant (or requiring intervention). The subject received treatment with steroids. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLUARIX. Nurse practitioner states subject received FLUARIX on 28 October 2008, and the following morning she developed lymphadenopathy on her neck region. Specifically, she has swollen lymph nodes above her clavicle on the right side mid-way up, and it is the diameter of a golf ball and is raised approximately 1-2 centimeters, and there is generalized erythema at this site. The swollen node is visible without palpation. Surrounding that area, there are palpable nodes that are each a centimeter in size. Below the clavicle, there are several poorly defined palpable nodes. Additionally, there are tender infraclavicular anterior nodes, axillary nodes, and tender nodes at the groove between the shoulder and chest. There is also a weblike red pattern over the neck area and upper chest. Currently, the subject is being treated with steroids. The reporter believes this is probably caused by FLUARIX since the subject experienced the same events last year after receiving the flu vaccine (Lymphadenopathy was experienced at the same location after receiving last year's flu vaccine (unknown which brand), however, it occurred a little bit later and lasted for 8 days).				Y					N	10/28/2008	10/28/2008	0	Unk	PVT	PVT	Oral contraceptive; Triamcinolone acetonide; Levocetirizine HC1; Allergy medication	Unknown	Allergy to Suprax; Allergy to Zithromax; Environmental allergy; Penicillin allergy; With the exception of the influenza virus vaccine, the subject had no adverse events following receipt of other previous immunizations.		A0754508A	1						1	Erythema; Lymph node pain; Lymph node palpable; Lymphadenopathy; Vaccine positive rechallenge	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3508a~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0331158	11/03/2008		2.0	2	.8	M	11/03/2008	This case was reported by a consumer and described the occurrence of seizure in a 3-year-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included bone marrow transplant, chronic skin disorder, immune deficiency, reflux unspecified and seizure. Previous and/or concurrent vaccination included influenza virus vaccine; manufacturer unspecified; unknown given on 6 June 2007. Concurrent medications included KEPPRA, PRILOSEC, CLARITIN, Vitamin D, Selenium and ZINC. On 6 June 2007 and 30 October 2008, the subject received 1st dose and 2nd dose of PEDIARIX (unknown, left thigh). On 6 June 2007, 5 minutes after vaccination with PEDIARIX, the subject experienced tremors of hands and lips. On 11 June 2007, 5 days after vaccination with PEDIARIX the subject experienced seizures, then again on 16 June 2007. On 30 October 2008, 5 minutes after vaccination with PEDIARIX, the subject experienced tremors of hands and lips and inappropriate schedule of vaccine administered. This case was assessed as medically serious by GSK. The immunization series was delayed, and symptom recurred following subsequent administration. The subject consulted a healthcare professional. The reporter stated the subject received PEDIARIX on 06 June 2007, and approximately five minutes after the injection he experienced hand tremors and lip tremors lasting approximately 10 to 30 seconds. On 11 June 2007, he experienced a seizure and on 16 June 2007, he had two additional seizures. The subject has a history of seizure and is taking seizure medication KEPPRA. On 30 October 2008, the subject received 2nd dose in the series of PEDIARIX (inappropriate schedule of vaccine administered) and again experience tremors of the hands and lips approximately five minutes after the injection lasting for 20 to 30 seconds. The subject was 3-years old at the time of the initial injection and 4-years old at the time of the most recent adverse event. On 30 October 2008, the events were resolved.				Y					Y	06/06/2007	06/06/2007	0	UNK	OTH	OTH	Levetiracetam; Omeprazole; Loratadine; Vitamin D; Selenium; Zinc Salt	Unknown	Bone marrow transplant; chronic skin disorder; immune deficiency; reflux unspecified; seizure; The subject experienced hand tremors after both vaccinations with PEDIARIX approximately five minutes after injection lasting approximately 20-30 seconds; the subject also had some tremors in his lips. The subject experienced seizures after the injection last year on 06 June 2007.		A0754631A	1						1	Convulsion; Inappropriate schedule of drug administration; Tremor	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~~1~UN~UN~DTAP + HEPB + IPV (PEDIARIX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0331163	11/03/2008	CA	6.0	6		M	10/23/2008	A serious spontaneous report of positive salmonella culture in blood and stool, bloody diarrhea and fever was received from a physician concerning a six-year-old male, subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received one dose of FLUMIST on 01-Oct-2008. The patient received a total of one dose before onset of the events 10 days later. On 11-Oct-2008 the physician reported her patient had symptoms of fever and bloody diarrhea. On 18-Oct-2008 the patient was hospitalized and noted to have positive blood and stool cultures for Salmonella. The patient was placed on intravenous antibiotics. it was reported that the patient is improving but remains hospitalized. The causality of the events to FLUMIST was not reported.  11/7/08 Reviewed hospital medical records of 10/18-10/23/2008. FINAL DX: salmonella gastroenteritis; bacteremia, resolved; diarrhea, resolved. Records reveal patient experienced HA, myalgia, fever & diarrhea x 7 days; developed bloody stools 10/13 & seen by PCP.  Peds ID consult done.					Y	6				10/01/2008	10/11/2008	10	Blood Culture, 10/18/08, Positive Salmonella; Stool Culture, 10/18/08, Positive Salmonella  LABS: WBC 10.4(N), H/H 11.8/33.9, monos 14.4%(H).  ESR 68(H).  CRP 5.6(H). Stool culture done by PCP (+) for salmonella, blood c/s (+) gm neg rods.  Sodium 133(L), chloride 97(L), ALT 46(H)	OTH	OTH	Concomitant Drug(s) Not Reported		PMH: folliculitis, influenza A&B 2/15/08.		MEDI0007328	1						1	Bacteria blood identified; Bacteria stool identified; Diarrhoea haemorrhagic; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0331164	11/03/2008	KS	17.0	17		M	11/03/2008	Rash bilateral arms, chest, back, face within 10 min. of injection. Gave 25 mg BENADRYL IM and 80 mg DEPO MEDROL IM. Within 5 minutes of BENADRYL rash beginning to resolve; within 15 minutes of BENADRYL rash completely cleared. No edema of face, throat, lips.									Y	10/29/2008	10/29/2008	0	None	PVT	PVT	Enalapril 15 mg, Metoprolol 50 mg, COUMADIN 10 mg	seasonal allergies/rhinitis	Mechanical aortic valve; HTN			1						1	Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLAA167AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331165	11/03/2008	IL				F	10/08/2008	(R) St red pain (pain rating 9 on 0-10 scale) injection given 10/16/08 it in office today 10/27/08 c/o severe pain				Y					N					PUB	UNK						1						1	Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~UN~UN~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0331166	11/03/2008	TX	61.0	61		M	11/03/2008	Patient stated that on 11/2/08 the day after the vaccine given that she had swollen lips and scratchy throat for approximately 2 hrs. -went away with no treatment necessary										07/11/2008	11/01/2008	113		OTH	UNK		None	None			1						1	Lip swelling; Throat irritation	FLU3~SANOFI PASTEUR~U2761AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331167	11/03/2008	TX	64.0	64		M	11/13/2008	severe bilat hip/waist low back pain; difficulty dressing from exam table.  CMP, CPK, UDIP, Uni Acid, SULINDAL Rx given today.  (exam:  non tender, from hip, & rash) (4- d out still after Sx)				Y					U	10/30/2008	10/31/2008	1	Pending (UDIP -)	PVT	UNK	PRAVACHOL	None	Thurb Arthritis;  Lumbar Laminectomy;  Possible Gout, Obesity			1						1	Activities of daily living impaired; Back pain; Musculoskeletal discomfort	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA185AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0331169	11/03/2008	IL	56.0	56		M	11/03/2008	Patient experienced tachycardia 7 days post vaccination.  MD attributed this to vaccination.  Patient required treatment with a beta blocker (Bystolic 5mg).  Pt took only 1 dose.  Had EKG done at MD office.  Pt stated HR approximately 60 normally and 93 when experiencing symptoms.				Y					Y	10/07/2008	10/14/2008	7	EKG at MD office	OTH	PVT	None	None	None			1						1	Electrocardiogram; Tachycardia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0331170	11/03/2008	IL	65.0	65		F	11/03/2008	Pt complains of sore arm persisting today after flu shot about 5 weeks ago. Took Tylenol #4 for a dental abscess and had not noticed any improvement. Pharmacist recommended she see MD and may try Ibuprofen or Naproxen in the meantime to help with pain and inflammation. Patient has MD appointment in approximately 2 weeks (around 11/13/08).				Y					U	09/24/2008	09/25/2008	1		OTH	PVT	Atenolol; Premarin; Lisinopril - HCTZ		No Known drug allergies; Hypertension			1						1	Pain in extremity; Tooth abscess	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0331171	11/03/2008	NJ	0.6	0	.6	M	11/03/2008	fever to 104 degree x 72hr				Y					Y	10/31/2008	10/31/2008	0		PVT	PVT	None	None				1						1	Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC2B198BA~3~IM~UN~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2794GA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF562AA~3~IM~UN~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C99079~3~IM~UN~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0903X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0331172	11/03/2008	WI	24.0	24		F	10/31/2008	5 min after vaccine felt nauseated, lightheaded.  BP= 130/80 Laid down for 20 min, left for home.  c/o 11:00 AM swelling of tongue + lips and throat felt tight no breathing problems, rested with HOB increase for rest of day.  All symptoms gone in AM.									Y	10/30/2008	10/30/2008	0	None	PVT	PVT	None	None	None			1						1	Dizziness; Lip swelling; Nausea; Swollen tongue; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA374AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331173	11/03/2008	WI	24.0	24		F	10/31/2008	20 min after vaccine, emp. c/o lightheadedness, tunnel vision, nausea, dizziness, report to supervisor and UWO- instructor who had employee lie down.  EMP. became shaky, clammy, diaphoretic, BP=140/80, P=120 T=98.6.  S/S continued X 4 hrs monitor by OR staff and doctor.  Drove self home later.  Symptoms gone in AM.  Took own BENADRYL.									Y	10/30/2008	10/30/2008	0		PVT	PVT	ZOLOFT for anxiety	None	None			1						1	Cold sweat; Dizziness; Heart rate increased; Hyperhidrosis; Nausea; Tremor; Tunnel vision	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA374AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331174	11/03/2008	PA	79.0	79		F	11/03/2008	Facial swelling, throat swelling, fever 104 degrees, nausea vomiting.				Y					Y	10/30/2008	10/30/2008	0		PVT	PVT	CORTEF; SYNTHROID;  FLUORINEF	None	Addison's;  Hypothyroidism			1						1	Nausea; Pharyngeal oedema; Pyrexia; Swelling face; Vomiting	FLU3~SANOFI PASTEUR~U2807AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331175	11/03/2008	MD	51.0	51		F	10/31/2008	Received flu shot 10/29/08 @ 10:30 am.  At 5:30 pm she had sudden numbness and swelling of her lower lip, also had nausea, vomiting & chills.  No dyspnea.  No ocular edema.  Treated with MEDROL dose pack- improving as of 10/31.									Y	10/29/2008	10/29/2008	0	None	PVT	PVT	DIOVAN;  Fish oil	No	None			1						1	Chills; Hypoaesthesia oral; Lip swelling; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U2747AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331176	11/03/2008	TX	60.0	60		F		10/31/08 - developed rash around neck, chest, upper torso. Warm feeling on skin -went to ER on 11-1-08 AM of 11-1-08.				Y					N	10/30/2008	10/31/2008	1		OTH	PVT	SYNTHROID; Lisinopril/HCTZ; Limbitrol; ASA; Vit E; PEPCID AC	None				1						1	Rash; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89987~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0331179	11/03/2008	WI	67.0	67		F	11/03/2008	Patient came in 2 wks after vaccine's were given complaining of pain in her arm that radiates down her arm.  Pain still persists & wakes pt up at night.  She has been treating it with ADVIL.				Y					U	10/18/2008	10/18/2008	0		OTH	PUB	TOPROL XL;  Multivitamin Calcium	None				1						1	Pain in extremity; Sleep disorder	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89800~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0551x~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331180	11/03/2008	WA	34.0	34		F	11/03/2008	Sore at injection site-feels like muscle is sore deep ache. Pain has continued from 10/16/08 to 11/03/08. Tender to palpation at injection site- no bruising or redness noted.									U	10/15/2008	10/16/2008	1	NONE	OTH	PVT		No	Arthritis			1						1	Injection site pain; Myalgia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88635~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331181	11/03/2008	IA	49.0	49		F	10/28/2008	10/23/2008 @ 13:00 2 1/4 cm x 2 1/2 cm reddened slightly swollen, slightly warm to touch @ injection site.  No fever aches/pain.									Y	10/22/2008	10/23/2008	1	None	PUB	OTH	Unknow	No	No			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA366BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331186	11/03/2008	PA	43.0	43		F	11/03/2008	Full body hives one hour after receiving flu vaccine									Y	10/27/2008	10/27/2008	0		PVT	UNK			Seasonal allergies, hazel nuts, bee stings			1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331607	11/03/2008	AZ	39.0	39		F	10/28/2008	This case was reported by a healthcare professional and described the occurrence of lump at the injection site in a 39-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). There were no concurrent medications. On 2 September 2008 at 10:00 the subject received unspecified dose of FLULAVAL at 0.5 ml, subcutaneously, in the left arm. On 3 September 2008, 24 hours after vaccination with FLULAVAL, the subject experienced lump at the injection site, injection site warmth and injection site redness. The drug was also									U	09/02/2008	09/03/2008	1	UNK	PVT	PVT	No concurrent medication	Unknown	The subject has no relevant medical history and no history of adverse events following previous vaccinations. The subject has not previously received flu shots.		A0746649A	1						1	Injection site erythema; Injection site mass; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA159AA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331608	11/03/2008	AZ	21.0	21		F	10/28/2008	This case was reported by a healthcare professional and described the occurrence of lump at the injection site in a 21-year-old female subject who was vaccinated with influenza vaccine FLULAVAL, (GlaxoSmithKline).  There were no concurrent medications.  On 2 September 2008 at 10:00 the subject received unspecified dose of FLULAVAL at 0.5 ml, subcutaneously, in the left arm.  On 3 September 2008, 24 hours after vaccination with FLULAVAL, the subject experienced lump at the injection site, injection site warmth and injection site redness.  The drug was also administered via the incorrect route.  FLULAVAL should have been given intramuscularly.  At the time of reporting the events were unresolved.  This event occurred in three subjects.  Linked cases included A0746645A and A0746649A.									N	09/02/2008	09/03/2008	1		PVT	PVT	No concurrent medication	Unknown	The subject has no relevant medical history and no history of adverse events following previous vaccinations.  The subject has previously received flu shots and no reactions were documented following administration.		A0746650A	1						1	Incorrect route of drug administration; Injection site erythema; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA159AA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331609	11/03/2008	TN	51.0			F	10/28/2008	This case was reported by a healthcare professional and described the occurrence of expired vaccine used in a 51-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline).  On 05 September 2008, the subject received the 1st dose of FLULAVAL (.5 ml, unknown, left arm).  The FLULAVAL vaccine administered had expired (Lot # ASLLA030AA; expired July 2008).									U	09/05/2008	09/05/2008	0	UNK	OTH	PVT		Unknown	The subject had no medical history and was not taking any concomitant medications at the time of vaccination with FLULAVAL.  The subject had a history of receiving previous influenza vaccinations.		A0747309A	1						1	Expired drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ASLLA030AA~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331610	11/03/2008					U	10/28/2008	This case was reported by a healthcare professional and described the occurrence of possible allergic reaction in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline).  On an unspecified date, the subject received unspecified dose of FLULAVAL (unknown).  At an unspecified time after vaccination with FLULAVAL, the subject experienced a possible allergic reaction.  An office staff member contacted the GSK Response Center and ask if FLULAVAL could be diluted, due to an allergic reaction.  The GSK representative who took the call stated that she realized after disconnection that the reporter may have been referring to a previous administration of FLULAVAL, not necessarily the components of another flu vaccine.  The GSK representative attempted to call back for further information, but the office was closed.  At the time of reporting, the outcome of the event was unspecified.  Follow-up information received on 07 October 2008 indicated that the vaccine given was not FLULAVAL.  It was apparently a reaction described by the reporter that occurred 20 years ago.  No additional information.									U				UNK	OTH	OTH		Unknown			A0748857A	1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331612	11/03/2008	IL	51.0	51		F	10/28/2008	The case was reported by a healthcare professional and described the occurrence of fever in a female subject aged between 40 and 49 years old who was vaccinated with FLULAVAL (GlaxoSmithKline), PNEUMOVAX, (Merck) and Tetanus diphtheria vaccine (Sanofi Pasteur).  On an unspecified date in September 2008, the subject received an unspecified dose of FLULAVAL (.5 unknown), an unspecified dose of PNEUMOVAX (unknown), and and unspecified dose of Tetanus diphtheria vaccine (unknown).  At and unspecified time after vaccination with FLULAVAL, PNEUMOVAX and Tetanus diphtheria vaccine, the subject experienced fevers of over 102 degrees Fahrenheit during the next five days.  The subject treated her symptoms at home, but was seen in the physician's office for a follow-up.  At the time of reporting, the event was improved.  Follow-up information received on 07 October 2008 indicated that the subject was 51 years old at the time of event.  She had never had flu or Pneumovax.  The subject's fever went up to 104 degrees F for 1 to 2 days starting on 12 September 2008 and then resolved.  In  the reporter's opinion, the event was possibly related to treatment with FLULAVAL.  All vaccines were administered intramuscularly at a dose of 0.5 ml each.  FLULAVAL and Pneumovax were administered in the same unknown arm.									Y	09/01/2008	09/12/2008	11	Body temperature, Sep2008, 102+ degreesFahr; Follow-up information receiving on 07 October 2008 indicated that the subject's fever went up to 104 degrees F for one to two days.	PVT	PVT		Unknown	A0748893A was one of two cases reported by the same healthcare professional.  A nurse reported that two female subjects in their 40's received FLULAVAL, PNEUMOVAX, and tetanus diphtheria vaccines during the same office visit.  Both subjects experienced fevers of over 102 degrees Fahrenheit in the next five days following the vaccinations.  Both subjects treated their symptoms at home, but were seen in the physician's office for follow-up.  Please reference report A0748888A for further information.  The subject never had flu or PNEUMOVAX.		A0748893A	1						1	Body temperature increased; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA171AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1960U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1|TD~AVENTIS PASTEUR~C29980A~UNK~IM~UN~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0331613	11/03/2008	IL	40.0	40		F	10/28/2008	This case was reported by a healthcare professional and described the occurrence of arm pain in a female subject aged between 40 and 49 year old who was vaccinated with FLULAVAL (GlaxoSmithKline).  On 08 September 2008, the subject received unspecified dose of FLULAVAL (.5 unknown, unknown).  At an unspecified time after vaccination with FLULAVAL, the subject experienced severe arm pain and presented to the emergency room for treatment, where she was prescribed prednisone at 40 mg for five days, vicodin and antibiotics.  The subject was seen for follow-up at the physician's office on 15 September 2008, when she informed the reporting nurse of the event.  The subject told the nurse that she did not know why she was prescribed the antibiotics.  At the time of reporting, the event was improved.  The healthcare professional considered the event was probably related to vaccination with FLULAVAL.  Follow-up information received on 07 October 2008 indicated that the subject was 40 year old at the time of events.  FLULAVAL was administered in an unknown arm.  On 12 September 2008, the subject experience arm pain and had swelling.  She was treated with Prednisone, Vicodin and Keflex.  The events resolved. In the reporter's opinion, the events were possibly related to treatment with FLULAVAL.				Y					Y	09/08/2008	09/12/2008	4	UNK	PVT	PVT		Unknown	The subject was not taking any concomitant medication at the time of vaccination with FLULAVAL.		A0748898A	1						1	Oedema peripheral; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA171AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0331614	11/03/2008	VA				U	10/28/2008	This case was reported by a healthcare professional and described the occurrence of a subject of unspecified age and gender getting sick following vaccination with FLULAVAL (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of FLULAVAL (unknown).  At an unspecified time after vaccination with FLULAVAL, the subject got sick.  At the time of reporting the outcome of the event was unspecified.  It was  reported that 20 flu shots were given and three subjects got sick.  Linked cases include A0749130A and A0749131A.  Follow-up information received on 13 October 2008 indicated that the event was not associated with FLULAVAL treatment, therefore, no additional information is expected.									U				Unk	OTH	OTH		Unknown	It was reported that 20 flu shots were given and three subjects got sick.  Linked cases include A0749130A and A0749131A.		A0749126A	1						1	Malaise	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA180AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331615	11/03/2008	VA				U	10/28/2008	This case was reported by a healthcare professional and described the occurrence of a subject of unspecified age and gender getting sick following vaccination with FLULAVAL (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of FLULAVAL (unknown).  At an unspecified time after vaccination with FLULAVAL, the subject got sick.  At the time of reporting the outcome of the event was unspecified.  It was reported that 20 flu shots were given and three subjects got sick.  Follow-up information received on 13 October 2008 indicated that the event was not associated with FLULAVAL treatment, therefore, no additional information is expected.									U				Unk	OTH	OTH		Unknown	It was reported that 20 flu shots were given and three subjects got sick.  Linked cases include A0749126A and A0749131A.		A0749130A	1						1	Malaise	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA180AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331616	11/03/2008	VA				U	10/28/2008	This case was reported by a healthcare professional and described the occurrence of a subject of unspecified age and gender getting sick following vaccination with FLULAVAL (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of FLULAVAL (unknown).  At an unspecified time after vaccination with FLULAVAL, the subject got sick.  At the time of reporting the outcome of the event was unspecified.  It was reported that 20 flu shots were given and three subjects got sick.  Follow-up information received on 13 October 2008 indicated that the event was not associated with FLULAVAL treatment, therefore, no additional information is expected.									U				Unk	OTH	OTH		Unknown	It was reported that 20 flu shots were given and three subjects got sick.  Linked cases include A0749126A and A0749130A.		A0749131A	1						1	Malaise	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA180AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331617	11/03/2008	CO	18.0	18		M	10/28/2008	This case was reported by a healthcare professional and described the occurrence of red area at injection site in a 18-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline).  Concurrent medical conditions included unknown allergies. Concurrent medications included Allergy injection.  On 16 September 2008 at 14:20 the subject received 1st dose of FLULAVAL at 0.5 ml, subcutaneously in the right arm.  This was considered to be the wrong route of administration.  FLULAVAL should be given intramuscularly.  On 17 September 2008, 1 day after vaccination with FLULAVAL, the subject experienced a red area at the injection site and swelling at the injection site.  At the time of reporting the outcome of the events was unspecified. Follow-up information was received on 14 November 2008, via pharmacist, who reported the subject was given FLULAVAL intradermally in the right forearm. The site was swollen and red for three days. The events resolved on 19 September 2008. The pharmacist considered the events possibly related to vaccination with FLULAVAL. The events were also associated with erroneous administration.									U	09/16/2008	09/16/2008	0	Unk	PVT	PVT	Allergy medication	Unknown Allergies	The subject has not previously received any flu shots and has no history of adverse events following previous vaccinations.		A0749266A	1						1	Incorrect route of drug administration; Injection site erythema; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~SC~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331618	11/03/2008	CO	15.0	15		M	10/28/2008	This case was reported by a healthcare professional and described the occurrence of red area at injection site in a 15-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline).  Concurrent vaccinations included TDAP vaccine (unknown manufacturer) and an unknown vaccine (unknown manufacturer) both given on 16 September 2008. On 16 September 2008 at 14:20 the subject received 1st dose of FLULAVAL at 0.5 ml, subcutaneously in the right arm.  This was considered to be the wrong route of administration.  FLULAVAL should be given intramuscularly.  This was also considered to be a medication error as FLULAVAL is not indicated for use in subjects under the age of 18.  On 17 September 2008, 1 day after vaccination with FLULAVAL, the subject experienced a red area at the injection site and swelling at the injection site.  At the time of reporting the outcome of the events was unspecified.									U	09/16/2008	09/16/2008	0	Unk	PVT	PVT		Unknown	The subject has no relevant medical history.  He has not previously received any flu shots and has no history of adverse events following previous vaccinations.		A0749268A	1						1	Incorrect route of drug administration; Injection site erythema; Injection site swelling	DTAP~UNKNOWN MANUFACTURER~~1~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~SC~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1|UNK~UNKNOWN MANUFACTURER~~UNK~UN~UN~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA		Influenza
0331619	11/03/2008	VA	39.0			F	10/28/2008	This case was reported by a physician via a general injectables and vaccines wholesaler and described the occurrence of shoulder pain in a 39-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline).  In 2008 the subject received unspecified dose of FLULAVAL (unknown).  In 2008, at an unspecified time after vaccination with FLULAVAL, the subject experienced right shoulder pain, pain in side of neck and swollen neck.  At the time of reporting the outcome of the events was unspecified.									U				Unk	OTH	OTH		Unknown			A0750093A	1						1	Local swelling; Musculoskeletal pain; Neck pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA151AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331620	11/03/2008	VA	57.0			F	10/28/2008	This case was reported by a physician via a general injectables and vaccines wholesaler and described the occurrence of upper arm pain in a 57-year-old female subject who was vaccinated with FLULAVAL, (GlaxoSmithKline).  In 2008 the subject received unspecified dose of FLULAVAL (unknown).  In 2008, at an unspecified time after vaccination with FLULAVAL, the subject experienced upper arm pain and pain in lower arm.  At the time of reporting the outcome of the events was unspecified.									U	01/01/2008	01/01/2008	0	Unk	OTH	OTH		Unknown			A0750094A	1						1	Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA151AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331621	11/03/2008	VA	38.0			F	10/28/2008	This case was reported by a physician via a general injectables and vaccines wholesaler and described the occurrence of shoulder pain in a 38-year-old female subject who was vaccinated with (FLULAVAL, GlaxoSmithKline). In 2008 the subject received unspecified dose of FLULAVAL (unknown).  In 2008, at an unspecified time after vaccination with FLULAVAL, the subject experienced left shoulder pain, neck pain and was unable to move arm at the shoulder.  At the time of reporting the outcome of the events was unspecified.									U				UNK	OTH	OTH		Unknown			A0750095A	1						1	Injected limb mobility decreased; Musculoskeletal pain; Neck pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA151AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331622	11/03/2008	VA	26.0			F	10/28/2008	This case was reported by a physician via a general injectables and vaccines wholesaler and described the occurrence of shoulder pain in a 25-year-old female subject who was vaccinated with (FLULAVAL, GlaxoSmithKline).  In 2008 the subject received unspecified dose of FLULAVAL, (unknown).  In 2008, at an unspecified time after vaccination with FLULAVAL, the subject experienced left shoulder pain, pain going down the left arm and it was painful to move the arm.  At the time of reporting the outcome of the events was unspecified.									U				UNK	OTH	OTH		Unknown			A0750096A	1						1	Musculoskeletal pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA151AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331626	11/03/2008	VA	59.0			F	10/28/2008	This case was reported by a physician via a general injectables and vaccines wholesaler and described the occurrence of shoulder pain in a 59-year-old female subject who was vaccinated with (FLULAXAL, GlaxoSmithKline).  In 2008 the subject received unspecified dose of FLULAVAL (unknown).  In 2008, at an unspecified time after vaccination with FLULAVAL, the subject experienced left shoulder pain and was unable to lift the arm.  At the time of reporting the outcome of the events was unspecified.									U				Unk	OTH	OTH		Unknown			A0750097A	1						1	Mobility decreased; Musculoskeletal pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA151AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331640	11/03/2008	VA	40.0			M	10/28/2008	This case was reported by a physician via a general injectables and vaccines wholesaler and described the occurrence of upper arm pain in a 40-year-old male subject who was vaccinated with influenza vaccine trivalent (FLULAVAL, GlaxoSmithKline).  In 2008 the subject received unspecified dose of FLULAVAL, the subject experienced right upper arm pain.  At the time of reporting the outcome of the event was unspecified.									U				UNK	OTH	OTH		Unknown			A0750098A	1						1	Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA151AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331641	11/03/2008	AZ	25.0	25		F	10/28/2008	This case was reported by a healthcare professional and described the occurrence of lump at the injection site in a 25-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). There were no concurrent medications.  On 2 September 2008 at 10:00 the subject received unspecified dose of FLULAVAL at 0.5 ml, subcutaneously, in the left arm.  On 3 September 2008, 24 hours after vaccination with FLULAVAL, the subject experienced lump at the injection site, injection site warmth and injection site redness.  The drug was also administered via the incorrect route.  FLULAVAL should have been given intramuscularly.  At the time of reporting the events were unresolved.  This event occurred in three subject.  Linked cases include A0745549A and A0746650A.									N	09/02/2008	09/03/2008	1	Unk	PVT	PVT	No concurrent medication	Unknown	The subject has no relevant medical history and no history of adverse events following previous vaccinations.  The subject has previously received flu shots and no reactions were documented following administration.		A0746645A	1						1	Incorrect route of drug administration; Injection site erythema; Injection site mass; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA159AA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331189	11/04/2008	MT	48.0	48		F	10/30/2008	Woke up w/mild hives.									Y	10/23/2008	10/24/2008	1	None	PUB	PVT	Hyzar; ASA	None	E-mycin; Benadryl; Albuterol; Augmentin			1						1	Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA367CA~7+~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331200	11/04/2008	CA	17.0	17		F	11/03/2008	Information has been received from a consumer concerning her 17 year old grand-daughter with allergy to penicillin and no pertinent medical history reported who on 28-OCT-2008 was vaccinated with the first dose of GARDASIL.  Concomitant therapy included NUVARING, flu vaccine (unspecified) (also given on 28-OCT-2008) and unspecified antibiotic.  After receiving her first dose of GARDASIL, on 28-OCT-2008, in the physician's office, the patient almost fainted and her head was flopping around.  The consumer stated that she thought it looked like a seizure.  At the time of reporting, the patient was recovering.  Upon internal review, seizure was considered to be other important medical event.  Additional information has been requested.									N	10/28/2008	10/28/2008	0	None	OTH	OTH	antimicrobial (unspecified); NUVARING; Influenza virus vaccine	Penicillin allergy			WAES0810USA05135	1						1	Convulsion; Hypotonia; Presyncope	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~1~UN~UN~HPV (GARDASIL)~1	USA		Influenza
0331205	11/04/2008	WI	83.0	83		M	10/30/2008	Increase S.O.B. Following flu vaccine. ER -intubated and admitted.  11/12/2008 ER record received for 10/13/2008 with DX:  Respiratory failure/possible anaphylaxis, ? allergic reaction. Pt developed SOB which was progressing quickly despite nebs. En route to ER EMS tx with epi, solumedrol and albuterol nebs. Unable to speak on arrival with labored breathing and minimal air passage. PE (+) for unresponsive to commands, mottling, intercostal retractions, agonal respirations, and lethargic.  Intubated with return of responsiveness and increased alertness.				Y	Y	7			Y	10/13/2008	10/13/2008	0	Labs and Diagnostics:  EKG shows non-specific ST/T wave changes. CXR (+) R pleural effusion.  ABGs abnormal. CBC with WBCs 18.0, RBCs 5.76, Hgb 13.6, MCV 73.1, MCH 23.6, RCDW 17.7%, Bands 15%, CMP with Glucose 167, BUN 32, Creatinine 1.7, GFR 42.	PVT	PVT	Albuterol; Carvedilol; Enalapril; Furosemide; Duo-Neb; Simvastatin; Spironolactone		COPD; DM; HTN; Hyperlipidemia. PMH: CHF s/p CABG. Pulmonary HTN. R pleural effusion.  Allergic to PCN			1						1	Dyspnoea; Endotracheal intubation	FLU3~SANOFI PASTEUR~U2752AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0331206	11/04/2008	WI	50.0	50		F		Flu vaccine given at 1045 at 1400 symptoms of hoarseness, lip swollen, throat tight.  Also had injection to back of neck on same day.  Also c/o chest pain and feet cramps, c/o cough and was anxious.  EPINEPHRINE, SOLUMEDROL, TORADOL, ATIVAN and PREDNISON given in ER.				Y					Y	10/24/2008	10/24/2008	0	Received 0.5cc LIDOCAINE injection in neck @ same appt. as flu vaccine given.	PVT	PVT	AMITRIPTYLINE;  PHRENILIN;  CIONAZEPAN;  NETIZON;  NEUROTIN; HCTZ;  DARVAET;  TIZADINE;  TRAMADOL	Neck and back pain	Anxiety disorder;  IBS;  fibromyalgia			1						1	Anxiety; Chest pain; Cough; Dysphonia; Lip swelling; Muscle spasms; Throat tightness	FLU3~SANOFI PASTEUR~U2752AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331207	11/04/2008	WI	26.0	26		F	10/30/2008	Tight throat, tingly, difficult swallowing.  Benadryl 25mg IM given.				Y					Y	10/22/2008	10/22/2008	0		PVT	PVT	Adderall; Welbutrin; Apri; Loratidine; Manalt	None				1						1	Dysphagia; Paraesthesia; Throat tightness	FLU3~SANOFI PASTEUR~U2739AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331208	11/04/2008	WI	21.0	21		F	10/29/2008	Flu vaccine given in AM around 1000-around 1300 developed S.O.B. legs aching, dizziness SOLUMEDROL, BENADRYL and PREDNISONE in ER				Y					Y	10/24/2008	10/24/2008	0		PVT	PVT	APRI	None				1						1	Dizziness; Dyspnoea; Pain in extremity	FLU3~SANOFI PASTEUR~U2809AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331217	11/04/2008	AZ	56.0	56		M	11/03/2008	Tingling in fingers on (L) arm, tingling to tongue, weakness to (L) arm.									Y	11/03/2008	11/03/2008	0	None	PVT	PVT	None	Ear infection	NKA	~Influenza (Seasonal) (no brand name)~UN~0.00~Sibling|~Influenza (Seasonal) (no brand name)~UN~0.00~Sibling		1						1	Muscular weakness; Paraesthesia; Paraesthesia oral	FLU3~SANOFI PASTEUR~U2740AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331219	11/04/2008	TX	11.0	11		F	11/04/2008	Acute neck lymphadenitis x 1 week after the shot of HPV and FLUVIRIN. Given Augmentin after ENT consult and diagnosis of ? Cat scratch vs ? HPV shot allergy.									Y	10/16/2008	10/20/2008	4	Other labs unremarkable. Labs + for EBV and CMV. Ab IgG only.	PVT	PVT	None	None	None except behavioral issues			1						1	Blood immunoglobulin A increased; Cytomegalovirus test positive; Epstein-Barr virus antibody positive; Lymphadenitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~0570X~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HPV4~MERCK & CO. INC.~88635~UNK~UN~LA~HPV (GARDASIL)~1	USA		Influenza
0331221	11/04/2008	WA	58.0	58		M	10/31/2008	Influenza vaccine administered 10/27/08, Employee called in by phone 10/31/08 to report numbness, tingling in (L) arm on 10/27. By 10/29, c/o numbness in mouth., Called PSP 10/31/08 - PCP recommended for employee to be seen at Urgent Care. 12/1/08-records received-presented on 10/31/08-C/O upper left arm sore with tingling sensation involving area of injection some tingling in radial distribution of left hand, aching of left wrist, slight tingling left side face around mouth and eye. No weakness, sensation okay, neuro negative. Assessment:paresthesia. Doubt vaccine reaction.										10/27/2008	10/27/2008	0		OTH	PUB						1						1	Hypoaesthesia; Hypoaesthesia oral; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA350AB~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331222	11/04/2008	NC	12.0	12		M	10/29/2008	20x14 cm are of swelling.  Area of swelling is warm with mild erythema noted more centrally.  Noted streaking, no induration or fluctuance.  No boils.  No other rash - 3 days after MENACTRA injection.  KEFLEX 500mg capsule 1 capsule oral 3 X daily.  #30 X 10 days prescribed for possible cellulitis.				Y					N	10/23/2008	10/25/2008	2	None	PVT	PUB		None	Lupus Left Ventricular Hypertrophy;  Bee stings;  Severe Local RA		NC08104	1						1	Erythema; Skin warm; Swelling	FLU3~SANOFI PASTEUR~U2795EA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2818ATA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~0533X~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0331223	11/04/2008	FL	54.0	54		F	10/31/2008	Pt. upper arm became very swollen all the way around including part of arm pit, throbbing pain all around and very firm to touch and warm heat, bruised approx 3-4 in in diameter where injection was given.  Took 2 days and warm soars before getting better.   Now only bruised.  No pain.  Also had loose stools for 2 days.									Y	10/26/2008	10/27/2008	1		PUB	OTH	Estrogel;  Motrin	None	None			1						1	Diarrhoea; Injection site haematoma; Injection site induration; Injection site pain; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~87923~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331229	11/04/2008	WA	49.0	49		F	11/04/2008	Pt rec'd flu vaccine IM (L) UE. Red itchy w/i 10. Within 30 redness enlarged mouth itchy				Y					Y	11/03/2008	11/03/2008	0	None	OTH	PUB		None	NSAIDS			1						1	Erythema; Oral pruritus; Pruritus	FLU3~SANOFI PASTEUR~U2799AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331230	11/04/2008	IN	19.0	19		F	11/09/2008	Shot - 10/30. Sore throat 10/31. Diffuse myalgias with fever to 100.1, cough and flu like symptoms - 11/1 - present.				Y					U	10/31/2008	10/31/2008	0	None	PVT	PUB	Albuterol	None	Asthma			1						1	Cough; Influenza like illness; Myalgia; Oropharyngeal pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8811004~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0331231	11/04/2008	NJ	59.0			F	10/23/2008	Pt. read influenza vaccine on 10/22/08 to Lt deltoid. On 10/23/08 she returned to the office with localized rash to the injection site. No difficulty breathing noted. Hydrocortisone cream given									Y					PVT	PVT						1						1	Injection site rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89973~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331236	11/04/2008	PA	33.0	32		F	11/04/2008	Tdap- Tender to touch, red, lump x2 days - lump size of quarter. Hives on face, chest 11/03/2008. Member also had FluMist-- sneezing, drainage, conjestion, persitant cough, body aches. Vaccines administered on 29 Oct 2008									U	10/29/2008	10/30/2008	1		MIL	MIL	None	None	None			1						1	Cough; Erythema; Mass; Sneezing; Tenderness; Upper respiratory tract congestion; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500557P~4~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TDAP~SANOFI PASTEUR~C2824AA~2~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0331237	11/04/2008	NY	41.0	41		F	11/04/2008	My lips and tongue became swollen, I became hoarse and wheezy and had to use my inhaler, my heart raced, I became dizzy and shakey.  I became extremely anxious									Y	11/03/2008	11/04/2008	1		PUB	UNK			asthma, numerous seasonal allergys	achey, fever~Influenza (Seasonal) (no brand name)~UN~32.30~In Patient		1						1	Anxiety; Dizziness; Dysphonia; Lip swelling; Palpitations; Swollen tongue; Tremor; Wheezing	FLU3~SANOFI PASTEUR~U2795AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331238	11/04/2008	MI	2.0	2	.7	F	11/04/2008	Patient received Flumist vaccine intranasally at approximately 6pm on 11/3/08.  She was previously doing well except for a cough approximately 4-5 days prior to the vaccine.  She woke her mom up at about 3AM with cough and complaints of being cold.  The patient awoke again at 0430 and the mom took the patients temperature with a temporal probe thermometer which read 101 F.  The child appeared confused to the mom and was asking questions such as what is that on the wall, why is there a giraffe on the wall, what are you going to be for Halloween.  These types of questions concerned the mother and propted a visit to the ER.  In the ER, the patient had a rectal temperature of 40.7 C which was treated with acetaminophen.  Her HR was also noted to be 170 on arrival.  Repeat temp was 38.2 C.  The patient was asleep most of the time in the ER.  Patient discharged home with instructions for treating fever and supportive therapy for viral illness.  Note, the patient had received an IM influenza vaccine in 2007 per mom, but never Flumist before 11/3/08.  Per the MCIR database, the patient received an influenza IM injection in 2006, not 2007.				Y					U	11/03/2008	11/04/2008	1	CXR negative.  WBC 9.1 (neutrophils 7.2 K/ul, Lyph 1.2 k/ul, monos 0.6k/ul, eos & basos 0).  Pt weight 13.9kg.	PVT	UNK	None	None per mom.	None per mom			1						1	Chest X-ray normal; Confusional state; Cough; Feeling cold; Lymphocyte count abnormal; Monocyte count decreased; Neutrophil count increased; Pyrexia; White blood cell count increased	FLUN3~MEDIMMUNE VACCINES, INC.~500567P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0331240	11/04/2008	PA	72.0	72		F	11/04/2008	Flu shot administered 10/14/2008 at 1:10 PM at clinic. Reaction was queasy at first, within minutes. Ten minutes afterward patient became somewhat dizzy and disoriented, which passed after a few minutes. Felt some cranial pressure for two days. Arm sore for a week after the shot.									Y	10/14/2008	10/14/2008	0		UNK	UNK	Crestor	None	Penecillin, shellfish.			1						1	Disorientation; Dizziness; Headache; Immediate post-injection reaction; Nausea; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331242	11/04/2008	MN	68.0	68		F	11/04/2008	1. a low tone, audible in left ear 2 days after the vaccine. 2.slight dizzyness 2 days after the vaccine, and then extreme dizzyness 3 days after the vaccine.									Y	10/30/2008	11/03/2008	4		PVT	PUB	Zyrtec-D, 2 a day	none that I'm aware of	was allergic to Horse Tetanus as a child, and my mother was allergic to Thymerasol	see # 19, above~ ()~NULL~~In Patient		1						1	Dizziness; Tinnitus	FLUX~UNKNOWN MANUFACTURER~don't know this~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331244	11/04/2008	WA	2.0	2	.0	F	11/04/2008	NONE.  PT GIVEN 0.5 ML INSTEAD OF 0.25 ML FLUZONE.  NO ADVERSE EVENT REPORTED.									Y	10/17/2008			NONE	PVT	PUB		NONE.	DEVELOPMENTAL DELAY.			1						1	Wrong drug administered	FLU3~SANOFI PASTEUR~U2804AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331245	11/04/2008	TX	67.0	67		F	11/04/2008	PATIENT SAID LEFT ARM ONLY WAS STIFF AND SOAR AND COULD NOT RAISE HER ARM ABOVE SHOULDER HEIGHT AND COULD NOT USE ARM TO PULL ON CLOTHING									Y	10/30/2008	10/31/2008	1		UNK	PUB	TAMOXIFIN	NONE				1						1	Injected limb mobility decreased; Musculoskeletal stiffness; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88636~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1381U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331247	11/04/2008	GA	3.0	3		M	11/04/2008	Sore throat, diorientation, vomitting. Revieved Flu Mist nasally.									Y	11/03/2008	11/03/2008	0		UNK	UNK	None	None	None			1						1	Disorientation; Oropharyngeal pain; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0331248	11/04/2008	CA	64.0	63		M	11/04/2008	Pain at injection site for 3 weeks									U	10/10/2008	10/10/2008	0		PVT	UNK	methacarbomal, levothyroxine, vicodin	follow-up visit	allergic rhinitis, sciatica, hypothyroidism, hyperlipidemia, Waldenstrom's macroglobinnemia			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U2784HA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331251	11/04/2008	SC	68.0	68		M	10/23/2008	Temp 103 degrees Tues pm (10/21/08)--fluctuated 101-103 degrees until Thursday 10/23/08.  RA had 4 cm circular red area directly below injection site and medial stripes on arm 1 cm X 5 cm.  Resolving as of 10/24/08.									Y	10/20/2008	10/21/2008	1	Unknown	PUB	PVT		none	Allergies:  Iodine		SC0814	1						1	Injection site erythema; Injection site streaking; Pyrexia	FLU3~SANOFI PASTEUR~U2765AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1679U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331252	11/04/2008	MO	39.0	39		F	11/04/2008	Approximately 3 cm diameter of redness with mild edema and discomfort at injection site. Compaint of generalized malaise and arthralgia 24 hours after receipt of vaccine.									Y	11/03/2008	11/04/2008	1		UNK	PVT		NONE	NONE IDENTIFIED			1						1	Arthralgia; Injection site discomfort; Injection site erythema; Injection site oedema; Malaise	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA367FLUA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331255	11/04/2008	FL	57.0	57		F	11/04/2008	FLU VACCINE ADMINISTERED LEFT ARM-PAINWITH LIFTING OR EXTENDING ARM. COMPLAINED OF KNOT IN LEFT ARM. 3MM NOTED ON UPPER DELTOID, NO ERYTHEMA; TAKING IBUPROFEN, HOT & COLD COMPRESSES.				Y					U	10/07/2008	10/07/2008	0		PUB	PVT			SEPTRA ALLERGY			1						1	Mass; Pain in extremity	FLU3~SANOFI PASTEUR~U2765AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331256	11/04/2008	CA	2.0	2	1	M	11/04/2008	acute hives, some erythroderma of soles, puffy eyelids, intense pruritis of feet, then trunk, then scalp, developing immediately after Fluzone, while pt still at my office.  no wheeze or cough.  treated w 30mg Allegra and 15mg Orapred ODT in office.  Mom reports the following a.m. that all sx resolved by 7pm, 3 hrs p immunization given.  no second dose of either med given.  [older sister got Fluzone of same lot at same time; no problem]									Y	11/03/2008	11/03/2008	0	Fluzone PF 2006 and Flumist 2007.	UNK	UNK	none	none	none	none~ ()~~0.00~In Patient|none~ ()~~0.00~In Sibling		1						1	Dermatitis exfoliative; Eyelid oedema; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~UT2785DA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331257	11/04/2008	FL	58.0	58		F	11/04/2008	flu vaccine administered left arm-c/o pain when lifting arm up. arm throbs unless taking ibuprofen;shot hurt terribly when given.				Y					U	10/07/2008	10/11/2008	4		PUB	PUB	NONE	NONE	NONE			1						1	Immediate post-injection reaction; Injection site pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2765AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331258	11/04/2008	FL	52.0	52		F	11/04/2008	RECEIVED FLU VACCINE; CANNOT LIFT ARM BUT A SMALL AMOUNT.ARM THROBS; CAN ONLY MOVE ARM STRAIGHT. HURT FROM TIME VACCINE GIVEN. TAKING IBUPROFEN AND USING HOT AND COLD COMPRESSES.				Y					U	10/07/2008	10/07/2008	0		PUB	PUB	NONE	NONE				1						1	Injected limb mobility decreased; Pain	FLU3~SANOFI PASTEUR~U2765AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331260	11/04/2008	FL	59.0	59		F	11/04/2008	FLU VACCINE REC'D 09-26-08. BEGINNING 9-27-08 PT HAD LOW BACK PAIN, MUSCLE ACHES ALL OVER; HAS BEEN VERY COLD AND ACHES & PAINS HAVE INTENSIFIED EVERY DAY SINCE.  oCTOBER 2, 2008 HAS BEEN THE WORSE DAY YET. STATES SHE IS ALLERGIC TO THIMERSOL, BUT PMD SAID OK TO TAKE FLU VACCINE.				Y					U	09/26/2008	09/27/2008	1		PUB	PUB	ATENOLOL,VIVELLE,GLUMETZA,BYETTA,ACTOS,NEXIUM	NOT APPLICABLE	DIABETES, THIMERSOL[EYE], PCN,TAPE,ASPIRIN,NSAIDS			1						1	Back pain; Feeling cold; Myalgia	FLU3~SANOFI PASTEUR~U2765AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331261	11/04/2008	FL	50.0	50		F	11/04/2008	AFTER RECEIVING FLU INJECTION, PATIENT HAD AN IMMEDIATE HEADACHE, BLURRED VISION.  BLURRED VISION LASTED APPROXIMATELY ONE HOUR.									Y	09/29/2008	09/29/2008	0		PUB	PUB		NOT APPLICABLE				1						1	Headache; Immediate post-injection reaction; Vision blurred	FLU3~SANOFI PASTEUR~U2765AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331262	11/04/2008	MO	28.0	28		M	11/04/2008	Fever, Cough, Chest Congestion, Sore Throat, Nasal/Sinus Congestion, Chills, Cold Sweats				Y					Y	10/27/2008	10/28/2008	1	None as of yet.  Doctor's appointment 11/5/08, 8:00am.	UNK	UNK	None	None		Flu Symptoms~Influenza (Seasonal) (no brand name)~UN~22.30~In Patient		1						1	Chills; Cold sweat; Cough; Oropharyngeal pain; Pyrexia; Respiratory tract congestion; Sinus congestion	FLUX~UNKNOWN MANUFACTURER~?~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0331264	11/04/2008	CA	9.0	9		M	11/04/2008	Abnormal blood glucose values in known diabetic for week following administration resulting in DKA.  Known Dx of DM1.  Patient at baseline has variable adherence to insulin therapy.  3/18/09 Received hospital medical records of 11/3-11/5/2008. FINAL DX: DKA resolved Records reveal patient experienced HA, nausea/vomiting x 1 day & increased glucose x 1 week.  Admitted PICU.  Tx w/IVF & insulin.  Patient admitted noncompliance w/diet recently as no evidence of infection.   Returned to ER 11/24/08. FINAL DX: vomiting, hyperglycemia Patient missed evening insulin dose & experienced vomiting, glucose 300, pH 7.28.  Tx w/IVF & insulin.  Improved, meds adjusted & d/c to home w/endocrine clinic f/u.			Y		Y	3			U	10/29/2008	11/04/2008	6	pH 7.29, glucose 408, + urine ketones  LABS: abnormal w/glucose 1000.  Anion gap 18.  Urine c/s neg. HgbA1C 8.85(H).  Alk phos 356(H).	UNK	UNK	Insulin: Lantus and NovaLog	No	DM1 since 7yo, asthma, ADHD  Family hx: kidney disease, CVA, DM.			1						1	Blood glucose increased; Blood pH decreased; Condition aggravated; Diabetic ketoacidosis; Urine ketone body present	FLU3~SANOFI PASTEUR~U2506AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0331265	11/04/2008	NY	12.0	12		M	11/04/2008	Patient was previously given dose of Tdap previous year.									Y	11/03/2008			None	PUB	PUB	NOne	None	None			1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500553P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B023AA~2~IM~RA~TDAP (BOOSTRIX)~1	USA		Influenza
0331266	11/04/2008	WI	30.0	30		F	11/04/2008	Had shot on Monday, October 27th and by Wednesday had a red raised area about 3 inches in diameter right around the injection site.  Also had aching into shoulder, elbow, and wrist.  Annoyingly painful but not limiting in any way.  It took over a week before it got better.  On November 3rd she saw nothing but still has some aching in  wrist and elbow.									U	10/27/2008	10/29/2008	2		PVT	UNK						1						1	Arthralgia; Injection site erythema; Injection site swelling	FLU3~CSL LIMITED~03249111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0331267	11/04/2008	MN	43.0	43		M	11/04/2008	PATIENT CAME TO CLINIC COMPLAINING OF A FEVER FOR THE LAST 5 DAYS.  SLIGHT COUGH, NO OTHER SYMPTOMS.									U	10/30/2008	10/31/2008	1	CBC, MONOSPOT, STREP SCREEN, AND URINE ALL NORMAL.  CHEST XRAY ALSO NORMAL.	UNK	UNK						1						1	Chest X-ray normal; Cough; Full blood count normal; Pyrexia; Streptococcal identification test negative; Urine analysis normal	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331268	11/04/2008	NE	43.0	43		U	11/04/2008	1 hr -- urticaria abd wall,  redness  eyes , dry mouth --  rx prednisone, benadryl-- full recovery  in 24 hrs									Y	11/03/2008	11/03/2008	0	none	UNK	UNK		none	none	none~ ()~NULL~~In Patient		1						1	Dry mouth; Ocular hyperaemia; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA 356 AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331269	11/04/2008	MD	64.0	64		M	11/04/2008	Employee presented in the occupational Health clinic on 10/21/08 for a influenza vaccination.  He told the RN that he had a mild URI illness but no fever and he consented to getting Flulaval after a brief discussion about postponing it until he felt well.  The following day he was admitted to Hospital from home with possible pneumonia.  Within days he was transferred by helicopter to Medical System where he remains in treatment.  The information we have comes via his supervisor.  He is reportedly on a ventilator and receiving steroids.  We have provided the hospital with the employee medical record.  12/22/2008 MR received for DOS 10/24-11/13/2008 with D/C DX:  Acute interstitial pneumonitis, respiratory failure, pulmonary embolism, acute renal failure and death. Pt transferred from local hospital (admitted 10/22/08)for hypoxemic respiratory failure following 6 months of progressive dyspnea and evaluation for lung transplant. On admission T=96.5'F, intubated and sedated with O2 sat of 96%, coarse bilateral breath sounds and tachycardic. Tx for pneumonia but developed DVT with PE which was symptomatic on 11/10/08.  Started on heparin but unable to be aroused from sedation. Platelet count dropped. Pt suffered a PEA arrest on 11/13/08 with restoration of BP and heartrate with CPR however BP difficult to maintain despite high dose pressors.  Life support withdrawn and pt died at  10:41 on 11/13/08. Autopsy  reports COD as Pulmonary Fibrosis due to a combination of acute pneumonia and organizing diffuse alveolar damage superimposed on a background of chronic interstitial lung disease and emphysema.	Y	11/13/2008	Y	Y	Y	14	Y		U	10/21/2008	10/22/2008	1	Labs and Diagnostics:  Chest CT (+) for opacity superimposed on severe pulmonary fibrosis, later (+) for PE.  Doppler (+) for DVT.  Head CT (-). HIT antibody (+).  Bonchoscopy (+) for diffuse alveolar hemorrhage and severe pulmonary fibrosis. CT abd/pelvis suggestive of inflammatory or infectious colitis.	UNK	UNK	Multivitmin	Upper respiratory symptoms, fatigue	HX OF MACROCYTIC ANEMIA/1988/SEEN BY HEMATOLOGIST 2002/WAS TO HAVE BONE MARROW BX HX OF SMOKING/1 PPD X 44 YEARS/WEARING PATCH HX OF (L) HIP PAIN ASSOCIATED WITH PRIOR TORN LIGAMENT WHICH HAS CALCIFIED/S/P PT AND CORTISONE INJECTIONS #2 2001 HX OF FATIGUE WEARS H/F RESPIRATOR APPROX. 2 X PER YEAR WHEN WORKING WITH AIRHANDLER'S EXHAUST FUMES  HX OF LOW HDL'S S/P LUMBAR LAMINECTOMIES 3/25/03 (L3,4,5) S/P THORACIC NERVE PROBLEM 12/03/SENT FOR MRI/DDD AND SPURS FOUND/SEES PT 2 X PER WEEK (1 1/2 MONTHS)/WILL CONTINUE WITH HOME EXERCISES Quit smoking entirely 12/2005 Full cardiac workup in 2006 including Cardiolyte Stress Test - normal, CXR.  Workup done d/t mild intermittent chest symptoms, fatigue PMH:  COPD, DM type 2, GERD, spinal stenosis s/p laminectomy, squamous cell carcinaoma of ear.  NKDA			1						1	Malaise; Mechanical ventilation; Pneumonia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA181AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Results in Death	Influenza
0331270	11/04/2008	CO	17.0	17		M	11/04/2008	Swollen neck (left gland), fever, shivers,severe headache, difficulty breathing, sroe throat, muscle aches, cough and felt tired				Y					N	11/01/2008	11/03/2008	2	Taken to PCP then to emergency room at hospital. Given shot of penicillan, xrays,	PUB	UNK	None	None	Allergic to dogs and horses			1						1	Chills; Cough; Dyspnoea; Fatigue; Headache; Local swelling; Myalgia; Oropharyngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0331271	11/04/2008	TX	55.0	55		F	11/04/2008	Patient verbalizes she became ill about 4-6 hours post vaccine @ 11:00 AM on 11-3-08. Symptoms:fever, body aches, nausea, vomiting.etc.				Y					Y	11/03/2008	11/03/2008	0		PUB	PVT	unknown	None stated on questionaire she filled before vaccine administration.	none stated on prescreening questionaire she completed prior to vaccine administration.			1						1	Nausea; Pain; Pyrexia; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA154AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0331272	11/04/2008	CA	6.0	6		F	11/04/2008	Patient recieved flu mist vaccine earlier in the day. At 2:45pm patient was unresponsive for 10+ minutes in the school yard. Ambulance called and taken to Emergency room				Y					Y	10/29/2008	10/29/2008	0	unknown	PUB	PUB	unknown	none stated on screening form	unknown			1						1	Unresponsive to stimuli	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0331273	11/04/2008	CA	21.0	21		F	11/04/2008	Pregnant patient was given Flumist. She did not have nay symptoms after   the administration. Incidetn reported to patient's OB GYN.									Y	10/31/2008				PUB	PUB			pregnancy			1						1	Drug exposure during pregnancy	FLUN3~MEDIMMUNE VACCINES, INC.~500560P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0331274	11/04/2008	CA	4.0	4		M	11/04/2008	Left Deltoid warm, hard, painful and swollen down to elbow, left arm 3/4  larger than Right, follow up call on 11/3 and 11/4 improvement in painfulness and other symptoms less each day									Y	10/31/2008	11/01/2008	1	none	PVT	PVT	none known	none	none	same rxn~Influenza (Seasonal) (Fluzone)~UN~3.00~In Patient|none~ ()~NULL~~In Sibling1		1						1	Injection site induration; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2755AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331277	11/04/2008	WA	12.0	12		M	11/04/2008	Left Swollen arm at injection site which is red, raised, warm to touch and painful. He is nauseated and has been since the evening after his flu shot on 11/01/08. His mom plans on taking him to his pediatrician				Y					U	11/01/2008	11/01/2008	0	unknown	UNK	UNK	unknown	none	unknown			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Nausea	FLUX~SANOFI PASTEUR~02839AA~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0331279	11/04/2008	UT	42.0	42		F	11/04/2008	Client complained of tightness in her chest about 15 minutes after receiving the flumist vaccine.  Denied difficulty with breathing, just a sensation of tightness.  Vitals were taken and B/P was high (147/97)- other vitals were normal.  She began to feel whoozie and was sent to the ER for evaluation.				Y					Y	11/03/2008	11/03/2008	0		PUB	PVT						1						1	Chest discomfort; Dizziness	FLUN3~MEDIMMUNE VACCINES, INC.~500545p~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0331281	11/04/2008	WA	10.0	10		M	11/04/2008	NONE.									Y	10/16/2008			NONE.	PVT	PUB		NONE.	OTITIS MEDIA.			1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U2806AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2544AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2998BA~1~IM~RA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1006X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0331282	11/04/2008	CA	77.0	57		F	11/04/2008	pt recieved pneumovax in left deltoid yesterday, started huring at night, not able to sleep. 6/ 10 pain- burning. radiates to shoulder, difficult to move arm, swollen. left arm cellulitis- rx for cephalexin, naproxen, alternating with otc tylenol, elevate arm, cool compress, er if worsens. right bicep 28 cm, right bicep 32 cm- +surgical scar, + swollen + warmth/ erythema				Y					U	11/04/2008	11/04/2008	0		PVT	PVT			nkda    Pt with left shoulder surg to repair fx 2007, hardward in place.			1						1	Burning sensation; Cellulitis; Erythema; Injected limb mobility decreased; Oedema peripheral; Pain in extremity; Skin warm; Sleep disorder	FLU3~SANOFI PASTEUR~u2764aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~09870x~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331283	11/04/2008	CA	35.0	35		F	11/04/2008	Received flu vaccination in left deltoid, reported that it hurt deeply.  The pain continued and it worsened.The joint and shoulder continues to hurt and has not improved significatnly without Advil. She has pain with movement of shoulder.									N	10/28/2008	10/28/2008	0		PUB	UNK	Thyroxin   Lipator     Premerin	none reported	No known			1						1	Arthralgia; Musculoskeletal pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331284	11/04/2008	CA	34.0	34		U	11/04/2008	10/31/08 @ 4:30pm: P.C. from pt. notifying PH of adverse reaction to flu shot.   By same evening of injection, pt. noticed redness and swelling to site.   Woke up next morning to increased redness and swelling with onset of diarrhea, nausea, and fever of 101.8.   Took Ibuprofen and Benedryl with good relief (denies respiratory distress).   Did not seek medical attention.  States feels better today.									Y	10/28/2008	10/28/2008	0	N/A	PUB	PUB	None	None	None			1						1	Diarrhoea; Injection site erythema; Injection site swelling; Nausea; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~4~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331289	11/04/2008	CA	46.0			F	11/04/2008	Pain at injection site lasting for 2 weeks, not relieved by Motrin, NSAIDS, Tylenol, ice/heat packs. Referred patient to PCP.				Y					U					OTH	PVT			None listed by patient			1						1	Injection site pain	FLU3~SANOFI PASTEUR~U2848AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331290	11/04/2008	NM	13.0	13		F	11/04/2008	Hives like rash at day 3-4D, Fever day 5, Joint and muscle pain debilitating by day 5, Admitted to hospital 10-28-08. WBC 32,000, ESR 70 - 124, CRP 7.3.   1/26/09 Reiceived hospital medical records for 10/28-10/31/2008. FINAL DX: not available on d/c summary available Records reveal patient experienced migratory joint pain, fever & migrating pruritic rash.  Had recent strep throat.  Tx w/IV antibiotics, NSAIDS & antihistamines.  Improved by d/c to home on continued oral PCN & w/outpatient cardio & rheum consults.  2/3/09 Received Rheum & ID consults. Rheum consult of 11/14/2008: FINAL DX: arthritis, carditis, fever, ?Still's disease Records reveal patient exp (+)GABS 10/26 after rash developed on 10/24.  Rash has waxed & waned since.  Remained on PCN & NSAID.  Exam revealed swollen wrists w/decreased ROM.  Labs & x-rays ordered.   Patient was being f/u by cardio.  ID consult of 11/18/2008: FINAL DX: fever, arthritis, rheumatic fever doubtful Records reveal review of extensive medical records w/o definitive diagnosis.  Referred back to cardio & rheum clinics.					Y	5				10/22/2008	10/25/2008	3	ASO (-); Blood culture (-); RF (-); (+) Rapid test for strep; Many others  LABS: Urgent care labs of 10/10/26/08: WBC 38,300, PMNs 92%.  ESR 70(H).   Hospital labs of 10/28-31/08: WBC 31,900, PMNs 93%.  ESR 124(H).  CRP 7.3(H).  ASO neg.  RA factor 19(H).  Echocardiogram abnormal & c/w mild carditis w/min mitral & tricuspid regurg.  EKG WNL.  WBC 21,900, neutros 80%, lymphs 18%.   ESR 120(H).  CRP 6.1.  ASO & antiDNAse B neg.  CXR & hand x-rays WNL.	PVT	PUB	None	None	None  PMH: sibling w/(+)GABS 10 /18			1						1	Arthralgia; Blood culture negative; C-reactive protein increased; Myalgia; Pyrexia; Rash; Red blood cell sedimentation rate increased; Streptococcal identification test; Streptococcal identification test positive; Urticaria; White blood cell count increased	FLUN3~MEDIMMUNE VACCINES, INC.~500560P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0381X~1~UN~LL~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2730AA~1~UN~RL~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B027AA~6~UN~RL~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~0994X~1~UN~LL~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0331291	11/04/2008	NV	7.0	7		M	11/03/2008	deep barking cough-onset app 2 hr after administration treatment at Urgent Care. BENDARYL injection				Y					Y	10/30/2008	10/30/2008	0		OTH	PVT	None	None	None			1						1	Cough	FLUN3~MEDIMMUNE VACCINES, INC.~500545P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0331293	11/04/2008	CA	87.0	87		F	10/31/2008	severe redness and swelling of entire right upper arm as well as lethargy and fatigue				Y					Y	10/28/2008				PVT	UNK						1						1	Fatigue; Injection site erythema; Injection site swelling; Lethargy	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA174AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1161X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0329799	11/05/2008	IA	52.0	52		F	11/03/2008	This serious case was received from a health professional on 23 October 2008. Seriousness criteria: Other - Medically Significant. A 52-year-old female, with a history of allergies to shampoos, body creams, nickel, and dyes, received an intramuscular left arm injection of FLUZONE (lot number U2766AA) on 21 October 2008. The patient was not ill at the time of vaccination, and had not previously received an influenza vaccine. Approximately four hours after vaccination, she complained of dizziness, blurred vision, tightness in the throat, and near syncope. She was seen in the emergency room, where she underwent an EKG in addition to blood pressure and heart rate monitoring. Treatment included diphenhydramine 50 mg intramuscularly. The patient recovered.				Y					Y	10/21/2008	10/21/2008	0		PVT	PVT			Allergies to shampoos, body creams, nickel, and dyes.  No illness at time of vaccination.		200803320	1						2	Dizziness; Electrocardiogram; Presyncope; Throat tightness; Vision blurred; Dizziness; Electrocardiogram; Presyncope; Throat tightness; Vision blurred	FLU3~SANOFI PASTEUR~U2766AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2766A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0331285	11/05/2008	WI	12.0	12		F	11/05/2008	PATIENT DEVELOPED BELL'S PALSY 5 DAYS AFTER RECEIVING FLU MIST NASAL				Y						10/30/2008	11/02/2008	3		UNK	UNK		NONE	NONE	BELL'S PALSY~Influenza (Seasonal) (FluMist)~NULL~12.00~In Patient		1						1	Facial palsy; Dyskinesia; Facial palsy; Lyme disease	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500569P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|MNQ~SANOFI PASTEUR~U2656AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2	USA	Emergency room visit	Influenza
0331300	11/05/2008	CA	57.0	57		F	11/03/2008	Initial report was received 23 October 2008 from a health care professional. A 57-year-old female patient had received an intramuscular left deltoid injection of FLUZONE SV 2008-2009, lot number U2764AA and five minutes later, she developed shortness of breath, facial flushing, her throat felt tight and her mouth felt dry. She was evaluated by her physician and her symptoms resolved within one hour. The patient had no concurrent illness and had not been taking any concomitant medications. The patient had a history of multiple medication allergies (medications not specified) and she had received FLUZONE in the past. According to the reporter, the patient requested a preservative free vaccine. The patient's recovery status was reported as unknown at the time of the report. Documents held by sender: None				Y					U	10/23/2008	10/23/2008	0	None	PUB	UNK			The patient had no concurrent illness and had not been taking any concomitant medications. Per the reporter, the patient was allergic to multiple medications (medications not specified).		200803321	1						1	Dry mouth; Dyspnoea; Flushing; Throat tightness	FLU3~SANOFI PASTEUR~U2764A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331303	11/05/2008	CA				F	10/31/2008	Initial report was received 30 October 2008 from a consumer, who is the patient.  A female patient stated that approximately two weeks ago, she received a flu vaccine manufactured by sanofi pasteur (lot number not reported) and subsequently experienced a severe allergic reaction.  The patient stated her physicians requested she obtain a list of the ingredients for the current years flu vaccine (2008), as well as ingredients for the 2007 and 2006 flu vaccines.  No additional information was provided at the time of the report.  Documents held by sender: None.				Y					U				Not reported	UNK	UNK			Not reported		200803382	1						1	Hypersensitivity	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331317	11/05/2008	MA	84.0	84		M		Pt was found on floor about 3:00 A.Mm this morning. At 8:00 A.M. nursing home reports left upper and left lower extremity weakness. Complained of chills. Was taken to hospital and remained there from Saturday A.M. to Wednesday P.M.  records received 11/14/08 for DOS 10/11-10/15/08-DC DX: right occipitoparietal CVA. Noted to have left side weakness, left homonymous hemianopsia, left hemineglect. Developed hematuria while on Coumadin. Follow-up Information 09-DEC-2008: Therapy given for weakness and to restore vision in left eye.				Y	Y	5			Y	10/10/2008	10/10/2008	0	11/14/08-records received-CT of head remarkable for acute right occipitoparietal CVA.  Carotid duplex mild stenosis bilateral internal carotid arteries. Echocardiogram revealed ejection fraction of 40-45% without any obvious intracardiac clot. Low EF and cardiomyopathy.	OTH	UNK	Fihasteride; CELEXA; PROTONIX		11/14/08-records received-PMH: recurrent CVAs.			1						1	Blindness unilateral; Chills; Computerised tomogram head; Hemiparesis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA91AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation	Influenza
0331318	11/05/2008	KS	59.0	59		F	10/30/2008	Pt states she received shot around 10:00am (10/29). Pt started having chills, fever 101, tight chest, hoarseness around 2:30pm. Pt denies any SOB. Pt states she went to her bed to sleep and felt better by 10:00pm yesterday (10/29/08).									Y	10/29/2008	10/29/2008	0		PVT	UNK	Vitorin 10mg/40mg take 1 tab PO/QD; Hormone Troche natural hormone therapy	None	Allergies: Iodine; Dxs: Hypothyradism, Hormone imbalance, Hyper Cholesterol, Hyperlipidemia, Hypocalcemia			1						1	Chest discomfort; Chills; Dysphonia; Pyrexia	FLU3~SANOFI PASTEUR~U2759AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331320	11/05/2008	NC	27.0	27		F	10/30/2008	Employee experienced redness, pain and significant swelling in arm after receiving the flu vaccine.  Employee stated the pain was more than just soreness.									Y	10/24/2008	10/25/2008	1		OTH	OTH	METHADONE; LEXIPRO; CLARITIN; Iron	None				1						1	Erythema; Oedema peripheral; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA373AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331322	11/05/2008	NC	5.0	5		M	10/31/2008	After pt received flu vaccine, went with parents to checkout.  While mom talking with dental management support staff, child falls, hits head, mom thought child had what looked like seizure as soon as nursing arrived no seizure activity noted.									Y	10/30/2008	10/30/2008	0		UNK	UNK		No	No		NC08107	1						1	Fall; Head injury	FLU3~SANOFI PASTEUR~U2809AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331323	11/05/2008	OR	79.0	79		F	10/13/2008	Pt states injection site very painful then developed large bruise on back of (L) hand. Arm is still sore 10d after injection. Visited ER- given NSAIDS. Bruise now diffusing				Y					U	10/02/2008	10/02/2008	0	None	OTH	OTH		None				1						1	Contusion; Injection site pain; Cyanosis; Erythema; Haematoma; Inflammation; Injected limb mobility decreased; Musculoskeletal pain; Musculoskeletal stiffness; Pain in extremity; Periarthritis; Skin nodule	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89123~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89123~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0331324	11/05/2008	WI	21.0	21		M	10/29/2008	Symptoms started with general fatigue which lasted all day.  By next morning patient had severe joint pain in elbows, knees, and back and a headache.  Patient was treated with 800 mg Motrin 3 X daily.									Y	10/23/2008	10/23/2008	0	None	MIL	MIL	None	None	None			1						1	Arthralgia; Fatigue; Headache	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA193AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331325	11/05/2008	MD	9.0	9		M	10/30/2008	Left upper arm swollen, warm to touch, redness began night of vaccine given and worsened over the next morning.									Y	10/29/2008	10/29/2008	0	None	PVT	PVT		None	NKDA			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2810AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331326	11/05/2008	CT	73.0	73		F	10/27/2008	pt. came to office 2 days past vaccination with large raised area at site of injection (per nurse who observed pt. was advised to go to her MD.  There were no other systemic indications 10/27 spoke with Pt.  who did not see MD after all.  She is ok.  Pt. states had a reaction (similar) to the pneumonia shot last year.  I advised to get flu shots by MD in future.				Y					Y	10/22/2008	10/22/2008	0		PUB	UNK		Seasonal allergy	Asthma as a child			1						1	Injection site rash; Similar reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~U2751AA~7+~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331327	11/05/2008	MN	42.0	42		F	10/29/2008	Approx 2 hrs after vaccine, scratchy throat, headache, followed by red itchy watery eyes, nasal congestion, feeling of having a lump in throat.  Most symptoms subsided over night but puffy, red eyes w/ discharge cont to next day.  Alleviated w/Benadryl.									Y	10/28/2008	10/28/2008	0		PUB	PUB	None	None	None			1						1	Eye pruritus; Eye swelling; Headache; Lacrimation increased; Nasal congestion; Ocular hyperaemia; Sensation of foreign body; Throat irritation	FLU3~SANOFI PASTEUR~U2810AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331328	11/05/2008	ID	51.0	51		F	10/30/2008	Approx 10 after vaccine c/o tingling sensation in throat. States has had anaphylaxis on several occasions and knew the feeling. Took 50 mg BENADRYL PO.				Y					Y	10/29/2008	10/29/2008	0		OTH	PUB		None				1						1	Anaphylactic reaction; Condition aggravated; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~AFLLA157AA~3~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0331329	11/05/2008	CA	29.0	29		F	10/25/2008	nurse c/o dizziness, lightheadedness, very weak.  Nurse instructed to sit down and drink water by flu nurse.  Flu nurse stayed present for over 20 min until nurse said she felt better, but remained slightly dizzy.  B/P 126/80, 86, 100% O2 rate upon completion of injection.  Later found nurse in ER still encouraging fluids, was given steroids and BENADRYL @ ER and given Rx as well when discharge to home.				Y						10/25/2008	10/25/2008	0		OTH	OTH	None	No	Pt has personal primary MD			1						1	Asthenia; Dizziness	FLU3~SANOFI PASTEUR~U2757AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331330	11/05/2008	OR	43.0	43		F	10/30/2008	Axillary lymphadenopathy on the side of injection. No localized reaction at injection site. She has malaise, fatigue.				Y					U	10/28/2008	10/30/2008	2	None	PVT	PVT	CELEXA; TREXIMET	None	Migraine; Depression/Anxiety			1						1	Fatigue; Lymphadenopathy; Malaise	FLU3~SANOFI PASTEUR~U27508A~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331331	11/05/2008	OR	45.0	45		F	10/30/2008	10/27/08 PM - Patient reports nausea, chest hurting under left breast, chills.  10/28/08 by afternoon, nausea resolved and no chills, but noticed right arm was swollen, red, hard, hot and itchy.  Redness size of silver dollar.  10/29/08 - reported to pharmacist at place of flu shot administration.  RPh prescribed ice to area and diphenhydramine.  10/30/08 - RPh followed up with patient.  Patient reports redness reduced to size of quarter and not itchy.									Y	10/27/2008	10/27/2008	0	None	OTH	PVT	Antidepressant; Thyroid med; Psychotropic	None	Sulfa allergy; no birth defects; depression; anxiety; brain tumor	Nausea/Aches~Influenza (Seasonal) (Fluvirin)~1~35.00~In Patient		1						1	Chest pain; Chills; Injection site erythema; Injection site induration; Injection site pruritus; Injection site swelling; Injection site warmth; Nausea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89975~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331332	11/05/2008	OR	76.0	76		M	10/29/2008	Developed shingles, diagnosed on 10/22/08 by culture				Y					U	10/11/2008	10/22/2008	11		OTH	PVT	Unknown	None Known	Unknown			1						1	Culture positive; Herpes zoster	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARZOS~MERCK & CO. INC.~1214X~1~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0331333	11/05/2008	RI	31.0	31		F	10/27/2008	First flu shot ever given at 2:35, observed for 10 minutes.  3:10 patient developed itchiness with one raised area (hive) right forearm, no SOB or systemic c/o.  3:15 patient given Benadryl 25 mg SL.  Area responded within 5 minutes.  4:10 rechecked asymptomatic.									Y	10/27/2008	10/27/2008	0		OTH	PUB	XANAX 2 mg qd; Singulair 10 mg ns; Albuterol PRN	None	History of asthma; no known allergies			1						1	Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89738~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331334	11/05/2008	CT	43.0	43		F	10/29/2008	Woman c/o itchy feeling on my neck, back and my abdomen about 10 min after receiving vaccine. Hives appearing on left lateral & posterior aspects of neck, right abdominal quadrant and left side of back. No resp. distress or swelling noted.  VS 140/80, AP 80, RESP 20. Woman refusing epinephen, SC. Woman took Benadryl 50 mg. po. 20 min later hives had completely disappeared and itchy feeling is gone woman stated.									Y	10/29/2008	10/29/2008	0		OTH	OTH	NKA	NKA	HX of Asthma			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2751AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331335	11/05/2008	MI	72.0	72		F	10/26/2008	Pt called the day after her PNEUMOVAX shot (10-25-08) and said that her arm was very sore, swollen, red, and that there was a large bump under her skin, I advised her to take 400mg ibuprofen every 4-6 hours and apply a cold compress				Y						10/24/2008	10/24/2008	0	NKA	OTH	OTH	Omeprazole; CELEXA; FORTEO; DESYREL; FOSAMAX	Sinus congestion	Sulfa allergy			1						1	Cold compress therapy; Erythema; Mass; Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0964U~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331336	11/05/2008	ID	13.0	13		F	10/29/2008	48 hours after flu shot given in left deltoid, the entire upper arm from shoulder to elbow is swollen, warm and itchy.  No evidence of cellulitis, no fever, no systemic reaction.									U	10/27/2008	10/27/2008	0	None	PVT	PUB	Albuterol; Singulair	None	Rhinitis			1						1	Injection site pruritus; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2795AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331337	11/05/2008	MA	71.0	71		F	10/30/2008	shot given at 3:00 pm- at 7:00 started with raspy cough- then rapid heart beat- nearly fainted- diarrhea-chills-2x vomited- severe chills-then night sweats.  weakness the next day.										10/28/2008	10/28/2008	0		OTH	OTH		None	None			1						1	Asthenia; Chills; Cough; Diarrhoea; Dizziness; Heart rate increased; Night sweats; Vomiting	FLU3~SANOFI PASTEUR~U2785HH~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331338	11/05/2008	SD	53.0	53		F	10/30/2008	Arm, back and head aches - tightness in chest and cough that evening, still felt achy the next day									Y	10/29/2008	10/29/2008	0		OTH	UNK		None				1						1	Back pain; Chest discomfort; Cough; Headache; Pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331340	11/05/2008	NC	5.0	5		F	10/31/2008	Wheezing									Y	10/30/2008	10/31/2008	1	None	PVT	UNK	None	None	Recurrent croup			1						1	Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0331341	11/05/2008	GA	3.0	3		F	10/31/2008	Local reaction 2d after vaccine given. Redness, swelling, and warmth at site.									Y	10/28/2008	10/30/2008	2	None	PVT	PVT	None	None	None			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Local reaction	FLU3~SANOFI PASTEUR~U2760AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331342	11/05/2008	UT	42.0	42		F	10/29/2008	Large, indurated erythematous area around the site of injection.  Painful - worst symptoms at approximately 36 hours post injection.									Y	10/27/2008	10/27/2008	0	Patient temperature, vital signs - all normal.	PVT	PVT	Multiple		NKDA			1						1	Body temperature; Injection site erythema; Injection site induration; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1295X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331345	11/05/2008	MA				M		No previous food allergies.  Flu vaccination at approximately 5:00 pm 10/28/08 - At 8:00 am 10/29, very itchy, red, small papular rash on left cheek, neck and scalp - given Benadryl PO at home - per PCP, child referred to allergist for ? egg allergy.									Y					PVT	PUB		None noted	None noted			1						1	Erythema; Rash; Rash papular; Rash pruritic	FLU3~SANOFI PASTEUR~U2766AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331346	11/05/2008	NV	43.0	43		F	10/24/2008	Received flu shot at approximately 10:00 am.  By 13:30 (1:30) had hoarseness and head itching and hot 'flashes', felt very warm.				Y					Y	10/24/2008	10/24/2008	0	None	PVT	PVT		None	None			1						1	Dysphonia; Feeling hot; Hot flush; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA366CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0331347	11/05/2008	MO	5.0	5		F	10/28/2008	15 minutes following the administering of an influenza shot pt. fell off mother's lap and was unresponsive and became stiff and started convulsing which lasted 15-20 seconds.  Pt did not experience incontinence.  Pt became responsive but dazed and for several minutes was unaware of what had happened or her surroundings.  911 was called and pt was ambulatory with an O2 sat of  99%.  Pt was transported to hospital accompanied by mother and 2 siblings.				Y					Y	10/25/2008	10/25/2008	0	O2 sat was 99%	PUB	OTH	Unknown	None	Unknown			1						1	Convulsion; Disorientation; Fall; Musculoskeletal stiffness; Oxygen saturation normal; Unresponsive to stimuli	FLU3~SANOFI PASTEUR~U2749AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331348	11/05/2008	AZ	53.0	53		F	10/29/2008	Oct 7 received flu shot and woke the next morning unable to lift arm due to pain and just couldn't get muscle to work. Very painful for the next couple of weeks.  Went to doctor on Oct 22 and he directed her to physical therapy- no tissue damage noted.  Is a little better but still has and ROM and difficult to move arm.									U	10/07/2008	10/08/2008	1	None	UNK	UNK	Neuvarrny;  BP meds	None	None except BP			1						1	Injected limb mobility decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA181AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331349	11/05/2008	AZ	67.0	67		F		Symptoms started 10 min after shot- Lips numb, shaky, no local reaction in arm. Roaring in ears. Was fine after about 30-40 min - no meds required. Received flu shot app 1 hour before pneumonia with no reaction.									Y	10/19/2008	10/19/2008	0	None	UNK	UNK	BP med and Hormone	None				1						1	Hypoaesthesia oral; Immediate post-injection reaction; Tinnitus; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~LA153B2~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0551X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331350	11/05/2008	CA	63.0	63		M		Came down with severe cold that has lasted over 7 days.									Y	10/21/2008	10/21/2008	0	No test given	PUB	PVT		None	None	None~ ()~~0.00~Patient		1						1	Nasopharyngitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88909~UNK~IM~AR~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331352	11/05/2008	MS	85.0	85		M	10/28/2008	Client received flu vaccine per protocol in R arm IM at approximately 10:30am.  Received phone call from daughter at 3:45pm stating he has read areas and whelps on his arms, legs and the trunk of his body.  Clients local PMD was contacted by family and he is being treated with BENADRYL/50mp PO Q8hr.									U	10/28/2008	10/28/2008	0	None	PUB	PUB	Unknown	None	None			1						1	Erythema; Urticaria	FLU3~SANOFI PASTEUR~U2802AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331353	11/05/2008	MN	65.0	65		M	10/30/2008	Patient reports pain in his right arm 10/28 when trying to sleep on right side.  He has an area on his right upper arm that is 8 inches by 5 inches anterior upper arm about 3 inches below injection site that is red and warm to touch.  Noted 10/29. Keflex 500mg one every 6 hours for 10 days.  Treatment started 10/30/08.				Y					N	10/28/2008	10/28/2008	0		PVT	OTH	LIPITOR; VIAGRA; SERTRALINE;  LEVOTHYROXINE; OSTEO BI-FLEX; Fish oil	None	None			1						1	Injection site erythema; Injection site warmth; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA359CA~2~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1295X~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331355	11/05/2008	CT	22.0	22		F	10/27/2008	1:30 pm vaccine given R deltoid, 1:40pm pt became diaphoretic pale, pupils dilated and rolled back up, became rigid with posturing noted, nonresponsive to verbal and tactile stimuli 1 minute responded ammonia inhalent, speech slurred, no resp.  distress, no RAGH, BLP 96/62 P84 Reg.  R 20 (9-1-1 activated) Pt. transfer E.R.				Y					U	10/27/2008	10/27/2008	0		OTH	OTH	Unknown	Unknown	Unknown			1						1	Dysarthria; Gaze palsy; Hyperhidrosis; Muscle rigidity; Mydriasis; Pallor; Posturing; Unresponsive to stimuli	FLU3~SANOFI PASTEUR~U2751AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331356	11/05/2008	SC	40.0	40		F	10/31/2008	On Oct 14, 08 12:30 pm I received a flu shot in my (L) arm and pneumonia shot in my right arm. The needle hurt extremely bad and the medicine going into my (R) arm burned really bad also. I went home afterwards. At 5:00 pm right arm from shoulder all the way down began severely hurting. I could not move my arm at all and I would scream out with agonizing pain. Not able to move my arm and its 9:30 pm, agonizing pain still. I went to emergency room October 15, 2008. Doctors put my (R) arm in a sling and pain medicines. Oct 25 got better was able to take sling off arm.				Y					Y	10/14/2008	10/14/2008	0	Severe reaction. Nurse put shot in wrong spot in arm, doctor said, The medicine burned going in. Needle hurt really bad.	UNK	OTH	Premarin 1.25mg	None	Disc Degeneration			1						1	Injected limb mobility decreased; Injection site pain; Pain in extremity; Screaming	FLU3~SANOFI PASTEUR~U2847AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~100SF~2~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331357	11/05/2008	KS	66.0	66		F	10/29/2008	Received Influenza (GlaxoSmithKline-AFLLA187AA) 10/27/2008 afternoon.  Couldn't sleep at night.  Woke up dizzy.  Vomited 3-4 times all day. Lasted all 10/28/2008.  10/29/2008 resolved.									Y	10/27/2008	10/27/2008	0	None	OTH	PVT	Lisinopril; Boniva (10 ct); Omeprazole	None	NKDA, HTN, Acid Reflux			1						1	Dizziness; Sleep disorder; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA187AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331358	11/05/2008	WA	1.16	1	.2	F	10/31/2008	Patient was given compromised (frozen) FLUZONE .25 ml prefilled syringe pediatric dose.									Y	10/30/2008			N/A	PVT	PUB		None	None			1						1	Wrong technique in drug usage process	FLU3~SANOFI PASTEUR~UT2794CA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331359	11/05/2008	WA	57.0	57		F	10/09/2008	Localized erethema Lt  upper arm, 8cm induration.									Y	10/07/2008	10/08/2008	1	None	OTH	PVT		None	Allergic to PCN, CODEINE, BALTRIM			1						1	Erythema; Induration	FLU3~SANOFI PASTEUR~U2802AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331360	11/05/2008	MO	94.0	94		F	10/31/2008	Raised lump several minutes after injection. Cold pack to area.									Y	10/31/2008	10/31/2008	0		OTH	UNK						1						1	Immediate post-injection reaction; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89994~UNK~ID~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331361	11/05/2008	IL	58.0	58		F	10/30/2008	Received flu & pneumonia vaccine approx 8:45 am on 10-28-08.  By noon her arm became extremely sore to where she could not lift it.  Rash under the skin & scratchy throat began 10-29-08 in the evening.  Red streaks were 5 by 5 in diameter & even under her armpits.   She began to cx of itching on her ears, nose, head.  Nurse adv. to seek medical attention.  Taking Claritin in afternoon and Benadryl in p.m.				Y					U	10/28/2008	10/29/2008	1	None	PUB	PVT		None	Sulfa			1						1	Injected limb mobility decreased; Pain in extremity; Pruritus; Rash; Skin striae; Throat irritation	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89923~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0038U~2~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331362	11/05/2008		31.0	31		F	10/24/2008	3 days ago FLUMIST at 08:45.  C/o itching 0300 & next AM back of legs with hives.  Took Benadryl which helped.  Recurred and lasted 2 days now resolving.  No dyspnea. No prior FLUMIST.  Exam normal but for 3 small wheals left elbow.									U	10/21/2008	10/22/2008	1	None	MIL	MIL	None	None	None			1						1	Pruritus; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500556P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0331363	11/05/2008	MI	2.0	2	.1	F	10/30/2008	Fever 103 degrees digital ax on 10-29-2008. Mild nasal congestion. No rash no vomiting no drooling.  Siblings had a febrile illness 2 wks ago.									U	10/28/2008	10/30/2008	2		PVT	PUB	None	None	None			1						1	Drooling; Nasal congestion; Pyrexia; Sick relative; Vomiting	FLU3~SANOFI PASTEUR~U2766AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331365	11/05/2008	WI	11.0	11		M	10/30/2008	No reaction.									Y	10/17/2008			None	UNK	PVT		None	None			1						1	Inappropriate schedule of drug administration; Unevaluable event	DTAP~SANOFI PASTEUR~C2950AA~5~IM~LA~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500568P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0331366	11/05/2008	TX	60.0	60		F	10/24/2008	Labyrinthitis vertigo, acute.				Y					N	10/04/2008	10/14/2008	10	Blood work, EKG, eye movement reflexes, spinning sensation, limb weakness	OTH	PVT	Singulair, Premarin	None	Ragweed, MT. Cedar, Mold, Fungus, Trees, Grasses			1						1	Blood test; Electrocardiogram; Eye movement disorder; Labyrinthitis; Muscular weakness; Vertigo	FLU3~CSL LIMITED~0149211A~UNK~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0331369	11/05/2008	CA	76.0	76		F	11/05/2008	Localized swelling, redness upper right arm with rash red to pink in color w/edema-Allergic urticaria 708.0 acute. Warm compresses tid-F/u for increased or change in sx's.				Y					Y	11/03/2008	11/04/2008	1		PVT	PVT			Amoxicillin			1						1	Drug hypersensitivity; Erythema; Local swelling; Oedema; Rash; Urticaria	FLU3~SANOFI PASTEUR~U2802AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1076X~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331370	11/05/2008	NY	10.0	10		F	11/05/2008	half dollar size red/purple area, swollen, itchy									U	11/03/2008	11/04/2008	1		UNK	UNK						1						1	Erythema; Pruritus; Skin discolouration; Swelling	FLU3~SANOFI PASTEUR~U2800FA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB257AA~1~IM~LA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~0989X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0331371	11/05/2008	MD	2.0	2	.6	F	11/03/2008	Epistaxis L nostril									Y	10/31/2008	10/31/2008	0		PUB	PUB		//// congestion, / epistaxis either nostril /// ////				1						1	Epistaxis	FLUN3~MEDIMMUNE VACCINES, INC.~560558P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0331372	11/05/2008	ME	3.0	3		F	11/04/2008	Fever, sore throat, stuffy nose.				Y					U	11/03/2008	11/04/2008	1	Rapid strep throat culture (-).	PVT	OTH						1						1	Nasal congestion; Oropharyngeal pain; Pyrexia; Streptococcal identification test	FLU3~SANOFI PASTEUR~U2771AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331373	11/05/2008	ME	46.0	46		F	11/03/2008	Swelling Redness Itchiness									Y	10/30/2008	10/31/2008	1		PVT	OTH		upper resp infection	None			1						1	Erythema; Pruritus; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA187AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|TDAP~SANOFI PASTEUR~C3028BA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0331374	11/05/2008	NE	34.0	34		F	11/05/2008	Lg. hematoma at injection site, itching swelling at inj site, vomiting, nausea, fever 103 degrees F.				Y					Y	10/22/2008	10/22/2008	0		PUB	PVT		None	Allergy to Penicillin			1						1	Injection site haematoma; Injection site pruritus; Injection site swelling; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2760AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331375	11/05/2008	PA	33.0	33		F	11/05/2008	6/26/08 @ 2:30pm- vaccine given; @ 6:30pm had moderate tenderness at vaccine site. 10/27/08 @ 6:30am had edema, tenderness, warmth and red welt-like area approximently 6cm diameter at injection site; pain in deltoid with any movement. 12:30pm took oral benadryl 25mg and continued every 6 hours x 3 days. 10-29-08 - edema less but now moderate itch @ site. 10-31-08. No swelling or itch									Y	10/26/2008	10/26/2008	0	None	OTH	OTH	None	None	None	edema/pain~Influenza (Seasonal) (no brand name)~1~27.00~In Patient		1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site pruritus; Injection site reaction; Injection site urticaria; Injection site warmth; Myalgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA374AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331376	11/05/2008	OK	54.0	54		F	11/05/2008	rash, breathing, feet swelled 1 hour post shot then 3 hours later heart raced, breathing got worse. Today R arm swollen with rash, weak, high fever, migraine				Y					N	11/03/2008	11/03/2008	0	Client does not know what labs were drawn.	PUB	UNK	Hyzaar, Verapamil, Pentasa, Actos, Lasix, Albuterol Nebulizer, Nexium, Lomotil, Prednisone, Benadryl	Lupus, Chrons, Diabetic, HTN	codeine, sulfa, iodine			1						1	Asthenia; Dyspnoea; Laboratory test; Migraine; Oedema peripheral; Palpitations; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U2772AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331377	11/05/2008	MA	0.5	0	.5	M	10/14/2008	Had 4 injections (DTap, PREVNAR, HIB and INFLUENZA vacc.) and one oral vacc. (ROTAVIRUS) @ 6 month WCC. The night of receiving vaccines had fever, temp 103.7 w/o Tylenol. Later next day > 24 hrs post vaccines developed rash - florid, generalized urticaria and erythema c/w erythema multiforme.				Y					Y	10/10/2008	10/11/2008	1	None	PVT	PUB	None	None	None			1						1	Erythema; Erythema multiforme; Pyrexia; Rash; Urticaria	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC221B150AA~2~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2782BA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~uf461aa~2~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C87338~UNK~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0414X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0331391	11/05/2008	DC	31.0	31		F	11/05/2008	Four hours post Flu-Zone injection in left deltoid, began feeling general malaise.  Next morning, awoke with a headache (pain of 4 on 0-10 scale) and upset stomach.									Y	11/04/2008	11/04/2008	0		PUB	UNK	Birth control for dysmenorrhea	none	none			1						1	Headache; Malaise; Stomach discomfort	FLU3~SANOFI PASTEUR~?~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331392	11/05/2008	FL	47.0	47		F	11/05/2008	Firm reddened area with localized blisters at injection site.  Dx: cellulitis post-injection				Y					U	10/15/2008	10/16/2008	1		UNK	PUB		none				1						1	Cellulitis; Injection site erythema; Injection site induration; Injection site vesicles	FLU3~CSL LIMITED~01949111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0331393	11/05/2008	FL	70.0	70		F	11/05/2008	70 year old female with 2inch round area of erythema, warmth and tenderness at injection site began shortly after receiving injection and sought treatment 4 days later.Patient placed on keflex for treatment of possible cellulitis secondary to injection.									Y	10/28/2008	10/28/2008	0		PUB	UNK	lisinopril; metformin	none	Diabetes, hypertension			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA356AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|TD~SANOFI PASTEUR~U20778A~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0331394	11/05/2008	CT	25.0	25		F	11/05/2008	After patient received the flu vaccine she went to the checkout window at our office and after approx. 2 minutes she reported to the receptionist that she didn't feel well. We immediately sat her down in a chair on the spot and attempted to speak to her. She was unresponsive for 1 minute and then started slowly to respond to us. We wheeled her to an exam room and did vital signs and blood sugar as she stated that she hadn't eaten breakfast and it was about 9:30am. Blood sugar was 101. VS wnl. Pt was cold and clammy. It took her about 10 minutes before she was able to say she was feeling better. Was seen by her Provider and cleared to leave. Advised to return to clinic PRN.									Y	11/04/2008	11/04/2008	0	Vital signs stable BP 124/80 pulse76reg temp97.4 random fsbs101	UNK	UNK	Protonix 40mg daily	no	GERD			1						1	Blood glucose normal; Body temperature decreased; Cold sweat; Feeling cold; Heart rate normal; Malaise; Unresponsive to stimuli	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89986~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331395	11/05/2008	OH	33.0	33		F	11/05/2008	On Oct 29th c/o numb, cold spot on right thigh that would come and go. The next day the same thing happened but more frequently. At the injection site of left deltoid she had some generalized stiffness and soreness which always occurs for her after a flu shot. This lasted for a couple of days. In addition to thigh the numbness also occured in right arm above the elbow. Same sensation, coming and going. C/o fatigue and weakness, and c/o extreme heat emanating from her head, felt like head was on fire. Saturday felt Ok when awakened but decided to go to Urgent Care anyway. What was a cold numbness became a white hot pain. In addition she c/o of intermittent numbness in neck, tops of shoulders, back, toes and left shin. C/o low back pain, fatigue, nausea and felt ill all over. In the evening she had the head burning again. To touch she was cool but felt like ears and cheeks were on fire. On Sunday felt better other than a little bit faint. On Monday intermittent feeling of weakness and fatigue and a few episodes of the white hot pain in head. Some muscle soreness in joints especially in wrists, right hip and neck. Occasionally felt sharp pin like sensation in neck and back. Also had some numbness and ringing in her ears. Had blood drawn for CBC and basic metabolic panel on 11/3. No results are back yet. Felt better Tuesday but had shooting needle-like pain in fingers of left hand. Some numbness in left leg and arm. Today she feels like her cheeks and ears are on fire and she just doesn't feel well at all. She has not been able to see her regular physician as of this time. Trying to make an appt with his covering physician. She was advised by Urgent Care physician to go to the Emergency Room if she has numbness that does not go away or if she starts vomiting.				Y					U	10/28/2008	10/29/2008	1	Had CBC and basic metabolic panel drawn on 11/03 and does not have results back yet.	UNK	UNK	Vitamins	No	Mitral Valve prolapse			1						1	Arthralgia; Asthenia; Back pain; Dizziness; Fatigue; Feeling cold; Feeling hot; Full blood count; Hypoaesthesia; Injection site induration; Injection site pain; Malaise; Metabolic function test; Myalgia; Nausea; Paraesthesia; Tinnitus	FLU3~SANOFI PASTEUR~U2771AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331396	11/05/2008	GA	44.0	44		M	11/05/2008	High fever, Severe head ache that lasted for 1 1/2 days. Body aches.									Y	11/03/2008	11/04/2008	1		PUB	PUB		None	Pollen allergies			1						1	Headache; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331397	11/05/2008	MA	63.0	63		F	11/05/2008	Developed cellulitus as a result of influenza vaccination				Y					Y	10/28/2008	10/28/2008	0	Received IV antibiotics	UNK	PUB	none	none	none			1						1	Cellulitis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~af11a180aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0331398	11/05/2008	PA	62.0	62		M	11/05/2008	Patient had very high blood pressure(214/112) the day following the flu shot, difficulty breathing, hoarseness, very pale, very weak, dizzy, fast heart rate.   Saw family doctor on 10-29-2008 doctor prescribed Atenolol and patient was told to go home and rest for a couple of days.  Patient was unable to work the rest of the week.				Y					U	10/28/2008	10/29/2008	1		PUB	PUB	Imipramine, Pravastatin Vardenafil	None				1						1	Activities of daily living impaired; Asthenia; Dizziness; Dysphonia; Dyspnoea; Heart rate increased; Hypertension; Impaired work ability; Pallor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0331399	11/05/2008	FL	56.0			M	11/05/2008	I had the flu shot administered by the local county health dept. at 2:30 yesterday.  At 10:30 I became feverish, nausea (vomited) then chills.									Y					PUB	PUB	Prem-Pro	none	none			1						1	Chills; Nausea; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331400	11/05/2008	TX	52.0	52		F	11/05/2008	hives all over body, swelling of lips, tongue, throat, difficulty swallowing				Y					Y	10/14/2008	10/17/2008	3		MIL	UNK	ASPIRIN 81MG EC, ATENOLOL 100MG,  ETODOLAC 400MG, FLUNISOLIDE 0.025% 200D NASAL INH SPRAY, FLUOXETINE  10MG CAP, HYDROCHLOROTHIAZIDE 25MG, LEVOTHYROXINE NA (SYNTHROID) 0.025MG, POTASSIUM CHLORIDE 8MEQ,  RANITIDINE HCL 150MG, SIMVASTATIN 40M	none	Diabetes, Hypertension, allergic rhinitis, GERD			1						1	Dysphagia; Lip swelling; Pharyngeal oedema; Swollen tongue; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89973~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0331401	11/05/2008	NY	29.0	29		M	11/05/2008	Burning sensation in the arm the injection was given in.  Went into the hand,  then felt like his lungs were getting tight. The burning started about 15 minutes after the injection the chest tightness was about 40 minutes after the injection.  Patient was given diphendydriamine 25mg, because he didn't want 50mg, PO. Started to feel better, didn't want to be transported to the ER via ambulabnce. So left, office after about 30 minutes.  On way back to the office he works out of he stopped at the ER for evaluation and was told he had a mild reaction to the vaccine.				Y					Y	11/03/2008	11/03/2008	0		UNK	UNK		none	NKDA			1						1	Burning sensation; Chest discomfort	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89992~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0331402	11/05/2008	VA	51.0	51		F	11/05/2008	Received flu shot at 1:45pm and 4:45 started feeling bad, palate swelling, eyes turned very red/blood shot, felt lungs filling with mucus  called Pharmacy to describe where shot was administered, they suggested taking Benedryl immediately, took a second dose 4 hours later.									Y	11/04/2008	11/04/2008	0	Please check with Pharmacy for manufacturer and lot number data	UNK	UNK		no previous illnesses	none			1						1	Feeling abnormal; Ocular hyperaemia; Palatal oedema; Pulmonary congestion	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331406	11/05/2008	NC	55.0	55		F	11/05/2008	Less than l day after receiving the flu vaccine, I abruptly started having severe neck pain from about the middle of my skull to my shoulder on my left side (the side of the vaccine.)  It was so severe that I took 1/2 dose of Skelaxin that had been prescribed to me for back pain (over a year ago) and went to bed.  The pain persisted so I used a warm compress and continued to rest thinking I must have injured my neck.  I began to suspect that the shot might be related when I started to have some chills. Today, Nov. 5, the neck pain has lessened greatly but still is present. I no longer have chills.				Y					U	10/30/2008	10/31/2008	1		UNK	UNK	none	no	told nurse could not take sulfa drugs, no medical conditions except probably scalp eczema			1						1	Chills; Neck pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0331410	11/05/2008	CA	3.0	3		M	11/05/2008	3yr old male given the Flumist on 10/06/08.  Nine days later he presented to my office with orbital cellulitis.  Pt.seen in ER 10/16/08 CAT scan showed preseptal orbital cellulitis. In addition he had pan sinusitis. Pt. had no resp. symptoms prodrome. Rx. with Vancomycin followed by Augmentin given. Pt. doing well now.				Y					Y	10/06/2008	10/16/2008	10	CAT scan on 10/16/2008.   CBC, Blood culture, CRP.	PVT	PVT		None	Probably has allergic rhinitis.			1						1	Blood culture; C-reactive protein; Cellulitis orbital; Computerised tomogram; Full blood count; Sinusitis	FLUN3~MEDIMMUNE VACCINES, INC.~500557P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0331412	11/05/2008	KS	6.0	6		F	11/05/2008	left arm is swollen and red from shoulder to above elbow. States notice swelling day after immunization.  Warm ot touch, child denies any pain.  PCP was called and he instructed to give Benadryl and apply cold packs. Parent state the same thing happened last year but did not report it.  States has only had problem with flu vaccine. Viewing immun. record received flu vaccine in 2006 in this office. no record of vaccine in 2007.									U	11/03/2008	11/04/2008	1		PUB	PUB				swollen arm~Influenza (Seasonal) (Fluzone)~1~4.30~In Patient		1						1	Erythema; Oedema peripheral; Skin warm; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U2829AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331413	11/05/2008	CA	7.0	7		M	11/04/2008	Hives on hands, shoulders, legs, arms, waist and face aproximately 2 hours after injection.  Treated with benadryl.									Y	11/04/2008	11/04/2008	0		MIL	MIL		slight congestion and sore throat prior to vaccination.				1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331415	11/05/2008	CA	22.0	22		F	11/05/2008	SWELLING AND REDNESS ON ARM,12CMX10CM OVER DELTOID WARM TO TOUCH. VERY PAINFUL, PT ALSO FELT VERY SICK WITH FEVERS AND BODY ACHES.									N	10/30/2008	10/31/2008	1		PVT	PVT		NONE	ASTHMA			1						1	Erythema; Malaise; Oedema peripheral; Pain; Pain in extremity; Pyrexia; Skin warm	FLU3~SANOFI PASTEUR~U2771A~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0669X~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~UF452AA~1~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0331416	11/05/2008	NV	5.0	5		F	11/05/2008	On Saturday, October 25, around 11:00am patient received a flu shot in her left thigh. By 5:00pm that evening she appeared fatigued and developed a fever. Her mother treated her with Tylenol. On Sunday, October 26, she complained of nausea and continued to be fatiqued with a fever between 101-102 degrees (f). Her mother continued to treat her fever with Tylenol. That evening after patient received her bath her mother noticed several red spots on her left buttocks. On Monday, October 27, patient developed itchy hives from the middle of her back down to her feet. Her mother took her to her healthcare provider and Benadryl was prescribed. The hives started to resolve after the treatment with the Benadryl. Patient's mother denies that she is allergic to eggs or to gelatin. Her mom states that she has had a least 1 flu shot in the past without any problems. On Tuesday, October 28, the hives flared up again and her mother took her back to their healthcare provider. A throat culture and urine analysis was none (negative). The hives resolved on Thursday, October 30, and the fever resolved on Monday, November 3.				Y					Y	10/25/2008	10/25/2008	0	Throat culture and urine analysis both negative	UNK	UNK	No routine medications	None known	None known	none~ ()~~0.00~In Patient|none~ ()~~0.00~In Sibling		1						1	Culture throat negative; Fatigue; Nausea; Pruritus; Pyrexia; Urine analysis normal; Urticaria	FLU3~SANOFI PASTEUR~U2806AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331418	11/05/2008	VT	55.0	55		F	11/05/2008	Patient c/o wheezing and coughinin that started within three hours after the immunization.  She also states that she had mild diarrhea for the following two days.									Y	10/31/2008	10/31/2008	0	Patient did not seek medical treatment.	UNK	UNK	None	None	None		NH0814	1						1	Cough; Diarrhoea; Wheezing	FLU3~CSL LIMITED~01849111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0331419	11/05/2008	MI	33.0	33		F	11/05/2008	Flu mist administered 10/27/2008.  Called stating that she had body aches, severe head ache, dizziness and nasal congestion.  She was told that she was having a response to the flu vaccine and would feel better in a few days.  She came into the office again today 11/6/2008 stating she is still having symptoms of head ache, dizziness, body aches and now jitteriness and rapid heart rate.									U	10/27/2008	10/28/2008	1		UNK	UNK			Alleergy to soaps, dust, pollen, cats, dogs.  No known allergy to eggs, gentamyacin, monosodium glutamate, sucrose or potassium phosphate			1						1	Dizziness; Feeling jittery; Headache; Heart rate increased; Nasal congestion; Pain	FLUN3~MEDIMMUNE VACCINES, INC.~500544p~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0331421	11/05/2008	IL	50.0	50		F	11/05/2008	Received vaccine around 11:15am. Started coughing with mucus and congestion around 2:30 pm. Also felt eyes swelling, became hoarse. Took over the counter Benadryl and Robitussin. Layed down. Started to feel mouth and tongue get funny. Headed to ER. Upon arrival to ER having trouble breathing. Ended up admitted to hospital. Discharge with oral Prednisone. Unsure of actual meds given in ER. No other abnormal ingested foods or meds that day. Influenza vaccine was only difference-11/14/08-records received  for DOS 10/28/08-presented to ED with C/O harsh barky cough and lips swelling on evening after receiving flu vaccine. Eyes itchy and red. Tingling in lips. Admitted overnight for angioedema questionable reaction to flu vaccine.				Y	Y	1			Y	10/28/2008	10/28/2008	0		UNK	UNK		No!				1						1	Dysphonia; Dyspnoea; Eye swelling; Feeling abnormal; Productive cough; Respiratory tract congestion	FLU3~SANOFI PASTEUR~U2743AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0331422	11/05/2008	NY	51.0	51		F	11/05/2008	Staff presented with bruise on the left deltoid area. She was vaccinated with flu vaccine on 10/29/08 and state that she noted bluish/ purplish discoloration 2 fingers width below the injection site on 10/31/08. denies pain, swelling, nor SOB. Seen on 11/3/08 and today 11/5/08. No treatment provided.Seen patient and noted on left upper arm from the injection site now 4 fingers width bluish/ purplish discoloration,and 4 fingers width from the antecubital area; no lumps, no swelling, no pain, no redness noted. good pulses, and with  FROM.										10/29/2008	10/31/2008	2	None	UNK	UNK	None	None	None	none~ ()~~0.00~In Patient|none~ ()~~0.00~In Sibling|none~ ()~~0.00~In Sibling		1						1	Injection site discolouration; Skin discolouration	FLU3~SANOFI PASTEUR~U2786CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331426	11/05/2008	MD	1.25	1	.3	F	11/05/2008	Patient given LAIV (fluMist).  Telephone call 11/5/08 to home, grandmother reports child is fine, has minor cold symptoms.  Told grandmother that child will still need 2nd flu vaccination this year and that TIV (injectable vaccine) is to be used for this dose.									Y	11/02/2008	11/02/2008	0		PUB	PVT						1						1	Inappropriate schedule of drug administration; Nasopharyngitis	FLUN3~MEDIMMUNE VACCINES, INC.~500544P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0331429	11/05/2008	TX	47.0	47		F	11/05/2008	VERY SORE MUSCLES, CAN BEND ARM BUT NOT ROTATE IT X 4 WEEKS.  COLD COMPRESSES AND ALEVE HELP SOMEWHAT.									Y	10/02/2008	10/02/2008	0	NONE	PVT	PVT	NONE	NONE	NONE			1						1	Joint range of motion decreased; Myalgia	FLU3~CSL LIMITED~01949111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0331431	11/05/2008	MO	30.0	30		F	11/05/2008	Influenza vaccine administered on 10/30/08. Pt. reports on 10/31/08 had burning sensation in right arm that morning. Reports she then developed itching on both arms, lower abdomen along beltline and lower legs.  She reports  taking Benadryl on Sunday evening, 11/02/08 to help relieve the itching.  Client presented to Health Department with raised, reddened rash with some scabbing to areas that she had scratched.  Rash was present on both arms, few spots on lower abdomen and few spots on lower legs below the knees.  Instructed pt. to follow up with physician.  She reported she had to work and was unsure if she would be able to follow up.  Spoke with pt. on 11/05/08 and she reported she did not follow up and rash was no longer itching and was beginning to clear up.									Y	10/30/2008	10/31/2008	1		UNK	UNK						1						1	Burning sensation; Pruritus; Rash; Rash erythematous; Scab	FLU3~SANOFI PASTEUR~U2768AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331432	11/05/2008	NY	5.0	5		M	11/05/2008	Child developed Guillain Barre Syndrome approximately three weeks after influenza vaccine with ascending muscle weakness. He required non-invasive ventilatory support for 3 to 4 days, NG tube feedings and received 5 doses of IVIG. He has recoved some muscle strength especially of his respiratory muscles (breathing room air with no support) and his upper arms. He is also tolerating full diet (well chopped). He is receiving physical therapy and is anticipated to be discharged home in the next week. 1/20/09-records received for DOS 10/26-11/12/08-DC DX: Acute infective polyneuritis.Presented to ED with C/O muslce weakness and gait abnormality, vomited and diarrhea prior to admission. Weakness and urinary incontenence. Weakness and difficulty breathing, autonomic instability. Constipation. Treated with IVIG. Blood pressure instability treated with antihypertensives.					Y	16			U	10/02/2008	10/23/2008	21	CSF viral and bacterial cultures negative. CSF protein 266. CSF glucose 65. Hep A and Hep B screen negative for infection,. EBV panel negative. Mycoplasma IgM negative. CK 93. Aldolase 5.6. ANA negative. Anti dsDNA negative. MRI of brain normal. MRI of spinal cord showed enhancement of the roots of the cauda equina both in the ventral and dorsal areas; this finding is often seen in Guillain Barre syndrome. 1/20/09-records received-MRI brain negative. C-reactive protein 226.1, CSF culture negative. CSF glucose 65, CSF protein 266.  influenza A virus Ag negative and influenza B virus Ag negative.Stool culture negative. HbsAB assay positive. Lactate dehydrogenase 228. Blood culture no growth. WBC 15.86. ESR 103.	UNK	UNK	Pulmicort (0.5mg) 1 vial BID; Singulair 4mg QHS; Albuterol nebulization solution/ MDI prn	Five day h/o headache; vomiting x 1 day five days prior to admission (associated with onset of headache). 1/20/09-records received-Five days prior to admission C/O headache and vomiting.	Asthma (mild to moderate persistent); history of positive PPD an 1 year of age (treated with 9 mos INH prophylaxis) 1/20/09-records received-PMH: asthma and sickle trait.			1						1	Aldolase normal; Antinuclear antibody negative; Blood creatine phosphokinase normal; Blood product transfusion; CSF bacteria no organisms observed; CSF culture negative; CSF glucose normal; CSF protein increased; CSF virus no organisms observed; Double stranded DNA antibody; Epstein-Barr virus test negative; Gastrointestinal tube insertion; Hepatitis A antibody negative; Hepatitis B antibody negative; Mechanical ventilation; Muscular weakness; Mycoplasma serology; Nuclear magnetic resonance imaging abnormal; Nuclear magnetic resonance imaging brain normal	FLU3~SANOFI PASTEUR~U2793EA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0331435	11/05/2008	IN	54.0	54		F	11/05/2008	PATIENT BROUGHT PRESCIPTIONS TO PHARMACY FROM FAMILY PHYSICIAN FOR NAPROSYN & HYDROCODONE/APAP 5/500MG TO TREAT LEFT SHOULDER PAIN/NERVE DAMAGE ON 11/5/08				Y					U	11/02/2008	11/05/2008	3		UNK	PVT	PREMARIN, SYNTHROID	NO	UNKNOWN			1						1	Musculoskeletal pain; Nerve injury	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88129 2P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0331438	11/05/2008	KS	43.0	43		F	11/05/2008	very uncomfortable pain in my arm within 1-2 hours after vaccination. Took Advil later in the evening. By the next morning, pain was severe and increasing. Joints from my shoulder to my elbow were stiff and painful; unable to move arm. Muscles/tendons/ligaments in arm felt affected (felt as if muscles had been ripped in my arm) Contacted office where vaccine was given 1 week later and was told to continue taking Advil and rotate arm so as not to get frozen shoulder.  I also asked what was in the vaccine and was told thimerosal - 59% mercury. Advil was not helping. Saw my primary doctor after that, she told me I probably got an allergic reaction to vaccine.  She told me to continue Advil and it should go away within 4-6 weeks. Called a pharmacist and she suggested I take Tylenol with Alleve.  Took for a few days- still not helping. Talked w/ my doctor's nurse and she had me start taking Zantac and Zyrtec.  Pain is not getting worse, but is not getting better.  I have also experienced some memory loss since vaccine- hard to concentrate; can't remember what I am supposed to be doing, etc. My arm also falls asleep throughtout the day (and night). Gets tingly. Not getting any better and it has been 3 weeks now.									N	10/14/2008	10/14/2008	0		PVT	PVT		none	asthma			1						1	Allergy to vaccine; Amnesia; Arthralgia; Disturbance in attention; Hypersensitivity; Joint stiffness; Pain in extremity; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89620~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331439	11/05/2008	CA	27.0	27		F	11/05/2008	Called  on 11/3/08 with concern her left arm began to hurt within an hour of receiving a flu shot at a walk-in free public clinic provided by on October 24, 2008. She stated she was having pain upon moving her arm,decreased mobility and grasp, and difficulty sleeping. 10 days after the shot, she is still having pain radiating down her arm when she uses it, but it is now more localized to her shoulder. Her opinion is the injection was given to high on her arm. She was advised to see her doctor to have her arm evaluated. She was seen by a physician at  a walk-in urgent care clinic on 11/5/08. The physician's discharge diagnosis was subacromial bursitis. He ordered: Rest of shoulder, take Ibuprofen 400mg 3x day, PT 3x week for two weeks and recheck in two weeks.				Y					U	10/24/2008	10/24/2008	0	Physical exam:	UNK	UNK	Vaccine received from Public Health Department. center coordinated nurses to give flu shots free to the public.	None, in good health	envionmental / seasonal allergies	none~ ()~~0.00~In Patient|none~ ()~~0.00~In Sibling|none~ ()~~0.00~In Sibling		1						1	Bursitis; Grip strength decreased; Insomnia; Joint range of motion decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2744AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331440	11/05/2008	MD	37.0	37		F	11/05/2008	11/3/08  1945- pt received flu shot  on 11/4/08 @ 0115 pt was awoken from sleep having problems breathing, lightheaded, feeling nauseous, with hands and feet tingling.  pt had husband get her some benadryl- after approx 30-45 minutes pt breathing became better.   pt is not on any other medications nor is there anything in pt history of the like. 11/5/08 pt md advised her to go to patient first because pt was still  feeling jittery from 11/4/08, pt bp was elevated but all other vitals stable. pt was sent home told to watch her bp and take benadryl of needed.				Y					Y	11/03/2008	11/04/2008	1		PUB	UNK	none	none				1						1	Blood pressure increased; Dizziness; Dyspnoea; Feeling jittery; Nausea; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0331441	11/05/2008	AK	52.0	52		M	11/05/2008	AFTER RECIEVING FLU SHOT WITH TIME LAPSE OF APPROX 2.5 HRS,EXPERIENCED SOB,HA,FATIGUE WHICH WAS SELF TREATED AT HOME WITH NEBULIZER OF ALBUTEROLX1,IAPATROPIUMX1, AND LAST WITH ALBUTEROL INHALER X1.									Y	11/01/2008	11/01/2008	0		UNK	PUB	ALBUTEROL INHALER,ALBUTEROL SO4,SERTRALINE HCL, MONTELUKAST NA, SYNTHROID, TIOROPIUM, FLUITCAS/SALMETEROL, IPRATROPIUM, MOMEHASONE FUROATE	NONE REPORTED	MODERATE COPD, DEPRESSION, TOBACCO USE, HYPOTHROIDISM.			1						1	Dyspnoea; Fatigue; Headache	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331453	11/05/2008	WA	10.0	10		M	11/05/2008	Hives- generalized- after rec'd FLUZONE, VARIVAX. Hx: allergies				Y					U	11/05/2008	11/05/2008	0	None	PVT	UNK		None	Allergies- sees allergist			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2808AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1153X~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0331454	11/05/2008	CA	1.6	1	.6	M	11/05/2008	2 hours after having vaccine he was febrile to 102-103 degrees, tired, no appetite x 2 days.									Y	10/29/2008	10/29/2008	0	Patient received .5ml FLUZONE not .25ml	PVT	PVT	None	None	None			1						1	Anorexia; Fatigue; Incorrect dose administered; Pyrexia	DTAP~SANOFI PASTEUR~C29323AB~4~UN~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2782CA~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB259AA~2~UN~RL~HEP A (HAVRIX)~1|HIBV~SANOFI PASTEUR~UE924AA~3~UN~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C46480~4~UN~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0331455	11/05/2008	WA	9.0	9		F	11/05/2008	Redness, itchy and swelling				Y					Y	11/03/2008	11/04/2008	1	None	PVT	PUB	None	None	None			1						1	Erythema; Pruritus; Swelling	FLU3~SANOFI PASTEUR~UT2829AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331456	11/05/2008	PA	57.0	57		F	11/05/2008	Pt having severe pain to both arms. No redness but slightly swollen per pt. No other symptoms as well per pt.									U	10/23/2008	10/23/2008	0	None	OTH	OTH	None		Herninated disc bilat neck, tear tendon			1						1	Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1541~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331458	11/05/2008	TX	50.0	50		F	11/05/2008	Pt received vaccine around 3 pm on 11/4 and at around 7 pm her throat began to tighten and eyes swell. She didn't have difficulty breathing. Pt took BENADRYL.									N	11/04/2008	11/04/2008	0		OTH	PVT		None				1						1	Eye swelling; Throat tightness	FLU3~SANOFI PASTEUR~U2761AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331460	11/05/2008	CA	1.0	1	.0	F	11/05/2008	3 cm induration and central crusting at injection site, of VARICELLA, no blisters.									Y	10/22/2008	11/05/2008	14	None	PVT	PUB	None	None	None			1						1	Injection site induration; Injection site reaction; Scab	FLU3~SANOFI PASTEUR~UT27850A~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB238AA~2~UN~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0356X~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C73459~2~UN~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1792U~UNK~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0331462	11/05/2008	VA	65.0	65		F	11/05/2008	Redness, swelling, and soreness at injection site, also experienced chills night before.									U	10/23/2008	10/24/2008	1		OTH	OTH		None	None			1						1	Chills; Injection site erythema; Injection site pain; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0061U~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331463	11/05/2008	VA	63.0	63		F	11/05/2008	Swollen arm, couldn't move it for a couple days, fever, pain, took a couple days off work. Pt. called MD, no treatment was given.									Y	10/02/2008	10/03/2008	1		OTH	PVT		None	None			1						1	Activities of daily living impaired; Limb immobilisation; Oedema peripheral; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0061U~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331464	11/05/2008	CA	32.0	32		F	11/05/2008	Day after getting shot started noticing swelling on upper arm. Elbow is sore. Soreness continues but no swelling. Pt has been taking IBU (otc).									U	10/08/2008	10/09/2008	1		OTH	PVT						1						1	Arthralgia; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331465	11/05/2008	NV	77.0	77		M	11/05/2008	Headache, fever: 101 degrees, chills, joint aches within 10 hours. Next day patient improved.									Y	11/04/2008	11/04/2008	0		OTH	OTH		None	None			1						1	Arthralgia; Chills; Headache; Pyrexia	FLU3~CSL LIMITED~01949111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0331467	11/05/2008	AZ	48.0	48		F	11/05/2008	Had cold chills the nite of flu shot with fever, headache and red blotches on arm. 5th day arm and body still sore. Got better and then got same symptoms back again in 10/27/08.									U	10/06/2008	10/07/2008	1	None	OTH	PVT	None	None				1						1	Chills; Feeling cold; Headache; Pain; Pain in extremity; Pyrexia; Rash macular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA181AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0551X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331468	11/05/2008	AZ	30.0	30		F	10/24/2008	Received flu shot at 0715. 1 hour after had a cough and symptoms progressed to sore throat, difficulty swallowing and throat feels tight. Reported rash and hives. Returned to school nurse. EMS called 11 AM and O2 given, Refused to go to hospital. Pt took 2 Benadryl tabs at home. Call made to pt at 5:45. She states feeling better.									Y	10/23/2008	10/23/2008	0	None	OTH	PVT		None	None			1						1	Cough; Dysphagia; Oropharyngeal pain; Rash; Throat tightness; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLL153BA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331469	11/05/2008	WI	58.0	58		F	10/29/2008	C/O cough, chills, throat closing up, sore throat, eye drng, blood shot eyes, possible fever. Was taking Tylenol for symptoms. No local site reaction reported.									Y	10/23/2008	10/24/2008	1	None	PUB	PUB		None	None			1						1	Chills; Cough; Eye discharge; Ocular hyperaemia; Oropharyngeal pain; Throat tightness	FLU3~SANOFI PASTEUR~U2744AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0742K~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C3027AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0331474	11/05/2008	CA	52.0	52		F	11/05/2008	Pain in left arm and into axilla, with raised red confluent rash over upper arm starting 24 hours following injection.									N	11/03/2008	11/04/2008	1	None	PVT	PVT		None	Completed chemo for colon ca			1						1	Axillary pain; Erythema; Pain in extremity; Rash papular	FLU3~SANOFI PASTEUR~U2753AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0224Y~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0330208	11/06/2008	VA	79.0			F	11/06/2008	This case was reported by a physician via an injectables and vaccine distributor and described the occurrence of convulsion in a subject of unspecified gender and age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 21 October 2008 the subject received a dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced convulsion. It was suggested that the subject was seen in the emergency room. Limited information was available. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. The person reporting this event was a distributor who sold the product to another distributor who then sold it to a medical doctor's office. The medical doctor's office contacted the second distributor with the limited information. It was reported that three subjects experienced convulsions and a female subject experienced a drop in her blood sugar and weakness and was taken to the emergency room. Linked case numbers include A0754328A, A0754338A, A0754339A and A0755269A. Follow-up information received on 05 November 2008, from the vaccine distributor who clarified that a 79-year-old female subject was vaccinated with FLULAVAL (GlaxoSmithKline) on 20 October 2008. At an unspecified time after vaccination with FLULAVAL, the subject experienced seizure activity (convulsion), hypoglycemia, weakness, diaphoresis and drooling. This case was assessed as medically serious by GSK. The subject had an electrocardiogram (EKG), chest x-ray and a computed tomography (CT) of the brain performed; results not provided. It was reported the subject was released within 24 hours, no other details provided. At the time of reporting, the outcome of the events were not specified.				Y					U	10/20/2008			The subject had an electrocardiogram (EKG), chest x-ray and a computed tomography (CT) of the brain performed; results not provided.	PVT	OTH		Unknown	Linked case numbers include A0754328A, A0754338A, A0754339A and A0755269A.		A0755229A	1						2	Convulsion; Asthenia; Chest X-ray; Drooling; Electrocardiogram; Hyperhidrosis; Hypoglycaemia; Scan brain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA208AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA208AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~2	USA	Emergency room visit	Influenza
0331443	11/06/2008	WA	6.0	6		M	11/05/2008	Multidisciplinary Note  Hem/Onc. Pt. in today for sick visit, c/o fevers.  Pt. arrived to clinic with fever of 38.3.  Pt had labs including blood cultures sent.  Received pt into the infusion center with fever 38.4.  Pt. received 400ml NS bolus IVx1 over 80 minutes without event.  Pt. received Zofran IVx1 as ordered over 20 minutes.  Pt. 'perked up' after receiving NS bolus.  Spoke with Dr. and as per the conversation, pt. ok for discharge to home.  PAC flushed with NS and Heparin 100unit/ml and deaccessed without complication.  Pt. left in care of mom and dad in stable condition.				Y					Y	10/24/2008	10/27/2008	3	neutrophils: 10/24/2008= 2652 ; 10/28/2008=10458  WBC: 10/24/2008=6.8; 10/28/2008=12.6 POLYS:10/24/2008=39.0; 10/28/2008=83.0 BLOOD CULTURES WERE NEGATIVE H 83.0 39.0 L 22.9	UNK	UNK	VINBLASTINE & ONDANSETRON ON THESE DATES: SEPTEMBER:05/12/19/26        OCTOBER:03/10	NONE NOTED BY PROVIDER	NEUROFIBROMATOSIS 1 WITH VISUAL PATHWAY GLIOMA&LIKELY LOWGRADE TUMOR INTO HIS BRAINSTEM			1						1	Blood culture negative; Neutrophil count increased; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8788205~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0331445	11/06/2008	AL	57.0	57		M	11/06/2008	pt presented to ED with c/o itching all over with whelps on trunk and hoarsness. pt stated recieving flu shot earlier in the day. pt took dose of benadryl at home but symptoms not resovled. pt given pepcid 20mg po and atarax 50mg IM as ED course.Sent home with RX for atarax, zantac, and told to take over the counter claritin for next 3-5 days.				Y					Y	11/05/2008	11/05/2008	0	medication as above	PVT	UNK	regular insulin,lisinopril,lovastatin,naproxen,tramadol,milk thistle cap,benadryl,lysine tab	none	hypertension,migraines,bach problems,IDDM,past hx of TB, acid reflux,herniated cervical disc, ulcers,   ALLERGIC TO PCN	none~ ()~NULL~~In Patient		1						1	Dysphonia; Pruritus generalised; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0331478	11/06/2008		48.0			F	11/05/2008	Information has been received from a pharmacist concerning a female in her either late 40s or early 50s who on 29-OCT-2008 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23.  It was unknown if the patient had received PNEUMOVAX 23 in the past. On the same day the patient also received a dose of flu shot in the opposite arm.  On 29-OCT-2008 the patient experienced pain upon injection.  Four hours later, her arm froze (the pharmacist unsure what the patient meant by this).  On 30-OCT-2008 the patient had pain but no visible symptoms and no swelling.  The patient also felt out of it.  The patient called the pharmacist.  It was reported that the patient had been taking TYLENOL and ADVIL for her symptoms.  At the time of the report, the patient had not recovered from the events.  The pharmacist considered the patient's symptoms to be disabling.  Additional information has been requested.								Y	N	10/29/2008	10/29/2008	0	Unknown	OTH	OTH			Unknown		WAES0810USA05335	1						1	Feeling abnormal; Immediate post-injection reaction; Injection site pain; Limb discomfort	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0331490	11/06/2008	IL	58.0	58		M	10/31/2008	Patient was S/P cycle 3 day 4 on 10/23/2008.  On 10/26/2008, patient went to hospital emergency room with chills, rigors, and SOB.  Patient chest x-rays on 10/26/2008 showed bibasilar pneumonia.  During the hospitalization, patient was treated with Zosyn, Azithromycin, Linezolid, and Tamiflu.  Patient was discharged from hospital on 10/30/2008. 12/29/08-records received for DOS 10/26-10/30/08-DC DX:Bilateral infiltrates likely pneumonia. Sudden onset of cough and collapsed, loss of consciousness.					Y	4			U	10/20/2008	10/26/2008	6	Chest X-ray PA/Lateral 10/26/2008 - bibasilar infiltrates.  Portable chest 10/27/2008, left lower lobe consolidation/atelectasis, right base unchanged, mild cardiomegaly.  Ventilation/perfusion lung scan 10/27/2008, suggestive of COPD, Portable Chest 10/28/2008, slight improvement.  Stable heart size.  US Venous Doppler Bilateral, 10/26/2008.  Negative WBC 10/26/2008-10/29/2008: 3.1, 3.5, 4.5, 4.2 Hgb 10/26/2008-10/29/2008: 11.5, 10.8, 10.7, 9.8 Hct 10/26/2008-10/29/2008: 32.5, 31.3, 31.2, 28.6.  Neutrophils 10/26/2008-10/29/2008: 63, 80, 81, 78.  Basophils 10/26/2008-10/29/2008: 0.0, 0.0, 0.0, 0.0.  O2 Saturation, 10/26/2008: 88.6, Non Rebreather.  Fungal smear 10/27: none.  Influenza Type A, B and RSV PCR, 10/27/2008: all negative.  Pneumocystis Carinii left lower lobe 10/28: negative.  10/26/08 left lower lobe lavage: pos gram, pos Cocci in pairs and chain, clusters.  Gram pos/neg bacilli.  10/27 respiratory culture: normal	UNK	UNK	Valcade 1.3 mg/m2-3mg-rv days 1.4, 8.11 of 21 day cycle.  Treatment days 9/8, 9/11, 9/15, 9/18, 9/29, 10/2, 10/6, 10/9, 10/20, 10/23.  Dexamethasone 20mg PO: days 1, 2, 4, 5, 8, 9, 11, 12 of 21 day cycle.  Start day cycle 1 9/8.  Start day		Multiple Myeloma, Diabetes Mellitus, Repair of Left Ear trauma, S/P MVA accident, Spinal surgery R/T MVA. Resection of left anterior chest mass. 12/29/08-records received-PMH:Multiple myeloma. Diabetes. Repair of left ear trauma status post motor vehicle accient. Spinal surgery. Transient ishcemic attack. Chemotherapy.			1						1	Atelectasis; Basophil percentage decreased; Bronchoalveolar lavage abnormal; Cardiomegaly; Chest X-ray abnormal; Chills; Dyspnoea; Fungus identification test; Gram stain positive; Haematocrit decreased; Haemoglobin decreased; Influenza serology negative; Neutrophil percentage increased; Oxygen saturation decreased; Pneumonia; Polymerase chain reaction; Respiratory syncytial virus test negative; Ultrasound Doppler normal; Ventilation/perfusion scan; Ventilation/perfusion scan abnormal; White blood cell count decreased	FLUX~UNKNOWN MANUFACTURER~89297BP~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~06691~UNK~IM~LA~PNEUMO (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0331491	11/06/2008	MA	63.0	63		F	11/02/2008	4 hours after flu shot, became very weak, unsteady on her feet; evolved sharp headache, sore throat. Called MD on 10/30, still feeling weak but slowly improving. No treatment needed; symptoms cleared 11/1/08.									Y	10/27/2008	10/27/2008	0		PVT	PUB	Duragesic Patch, Methadone, Neurontin, Levothyroxine, Hydrochlorothiazide, Klonopin, Simvastatin, Percocet, Fioricet, Metoprolol, Aspirin, Benadryl, Melatonin, Multivite, Calcium, Omega-3	None	Coronary disease, Hypothyroid, arthritis, chronic bronchitis			1						1	Asthenia; Gait disturbance; Headache; Oropharyngeal pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331492	11/06/2008	OR	45.0	45		F	10/31/2008	R supraclavicular 4-5 cm tender lymph node surrounded by 1-2 cm tender nodes. R Inferclavicular nodes also swollen/tender but more precisely defined. All with overlying erythema with connecting lines between nodes. Several anterior axillary nodes enlarged but not tender. On neck nodes are not enlarged but neck is sl tender esp ant cervical clavicle. Afebrile.				Y					U	10/28/2008	10/29/2008	1	None	PVT	PVT	TriNessa, Nasacort AQ, Xyzol, allergy shots	None	PCN, Erythromycin, Suprex, Numerous mild envirnomental allergies- sinusitis	same as current exam~Influenza (Seasonal) (no brand name)~1~44.00~In Patient	OR200838	1						1	Erythema; Lymph node pain; Lymphadenopathy; Neck pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3508A~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0331493	11/06/2008	OR	1.3	1	.3	F	10/31/2008	Red induration with pruritus at the site of INFAMRIX injection.				Y					Y	10/29/2008	10/30/2008	1		PVT	PUB		None	None		OR200837	1						1	Injection site erythema; Injection site induration; Injection site pruritus	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B065AA~2~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2808AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1861U~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0331495	11/06/2008	OR	10.0	10		F	11/03/2008	Swelling around eyes 1 hour after the dose was given and then swelling in cheek and upper face. No trouble breathing.									Y	11/01/2008	11/01/2008	0	We are checking for egg allergy but has had eggs in past and flu shots without any trouble.	PVT	PVT	None	Maybe getting viral illness- on ///// @ night	sulfa			1						1	Allergy test; Eye swelling; Swelling face	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881176P~6~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331496	11/06/2008	NC	21.0	21		F	10/17/2008	Redden at injection site, Itchy, Red appearance, Hives				Y						10/17/2008	10/17/2008	0		OTH	OTH	Birth Control	None	Augmentin			1						1	Erythema; Injection site erythema; Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89747~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0331497	11/06/2008	PA	53.0	53		F	10/31/2008	Maladministration of FLULAVOL vaccine, given interdermal 0.1 ml L forearm at 10:05 am on 10/31/08. Patient remained under observation for one hour after improper administration.									Y	10/31/2008	10/31/2008	0	None	PVT	PVT	Advair, Spiriva, Seroquel, Benicar, Norvasc, Tubelin Purified Protein		HTN/Depression/COPD			1						1	Incorrect route of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA154AA~1~ID~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331498	11/06/2008	OH	48.0	48		F	11/01/2008	Area around injection site became red the next day after the injection. The site was still red and itchy 2 weeks later. Advised Benadryl and hydrocortisone cream to treat, and to see the doctor if symptoms persist.									U	10/18/2008	10/19/2008	1	None	OTH	PVT	Unknown	None	None			1						1	Injection site erythema; Injection site pruritus	FLU3~CSL LIMITED~02049111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0331499	11/06/2008	NJ	37.0			F		Dizziness, facial swollen lip swollen within 30 min of given vaccine.				Y					Y		10/10/2008			PVT	UNK		None	None			1						1	Dizziness; Lip swelling; Swelling face	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0331500	11/06/2008	NJ	55.0	55		M	10/24/2008	Pt started to feel sick; ambulance was called by co-workers. Pt vomited x 3 in ambulance. Upon arrival at hospital, pt rec'd Benadryl po; said he felt better almost immediately. Pt observed, then dc'd.				Y					Y	10/18/2008	10/18/2008	0	None	PUB	PUB	None	None	None			1						1	Malaise; Vomiting	FLU3~SANOFI PASTEUR~U2744AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331504	11/06/2008	CA	46.0	46		F	11/03/2008	Sore arm by evening- hurt to touch.                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Sore arm by evening - hurt to touch. Woken several times during the night, shivering, feverish. Nausea and headache next day preventing me from going to work. Recovered by late afternoon the day following the vaccination.                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Sore arm by evening- hurt to touch. Woken several times during the night									Y	10/23/2008	10/23/2008	0	None	UNK	PVT		None				1						1	Chills; Headache; Hyperaesthesia; Nausea; Pain in extremity; Pyrexia; Sleep disorder	FLU3~SANOFI PASTEUR~U2948AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331505	11/06/2008	SC	7.0	7		F	11/03/2008	Received vaccine 10/27/08. Seen in ER with hives 11/01/08. Given Benadryl 25 mg PO. Epinephrine 1: 1000 0.3 mg SQ. Note - was around Cousin who was also seen with hives - no vaccine.				Y					N	10/27/2008	11/01/2008	5		PVT	PUB						1						1	Urticaria	FLU3~SANOFI PASTEUR~U2828AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0792X~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0331507	11/06/2008	NM	44.0	44		F	10/30/2008	Erythema/redness 8x9 cm. T 97.6. Symptoms started 3-4 hrs after injection. Post-nasal drip with nasal congestion.									Y	10/28/2008	10/28/2008	0		PUB	UNK	None	None	None			1						1	Erythema; Nasal congestion; Postnasal drip	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA381CA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331508	11/06/2008	TX	2.0	2	.7	M	10/31/2008	Generalized abdominal pain around 24 hrs after FLUMIST . 1 hour after exam (day after imm) child up and walking around asking for food. Child brought to MD secondly to persistent inconsolable crying x 1 hour.									Y	10/29/2008	10/30/2008	1	CBC - nl, BMP - nl	PVT	PVT		None	Pre-term infant			1						1	Abdominal pain; Crying; Full blood count normal; Metabolic function test normal	FLUN3~MEDIMMUNE VACCINES, INC.~500577P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0331509	11/06/2008	NE	55.0	55		M	10/31/2008	7 hrs after vaccination had headache, neck and back ache, body aches, right knee aching, rhinitis and urinary frequency lasted about 60 hours. Self treated with Aleve.									Y	10/23/2008	10/23/2008	0	None	OTH	PVT	Nexium daily	None	Environmental allergies			1						1	Arthralgia; Back pain; Headache; Neck pain; Pain; Pollakiuria; Rhinitis	FLU3~SANOFI PASTEUR~U2766AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331510	11/06/2008	PA	7.0	7		F	10/30/2008	Fever of 104 degrees and left deltoid tenderness and swelling.				Y					Y	10/22/2008	10/23/2008	1	None	PVT	UNK	Singulair, Xopenex, Zyrtec	None	Strep Throat (10/7/08), Asthma			1						1	Muscle swelling; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U2755A~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0868X~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331511	11/06/2008	TX	50.0			F	11/04/2008	Patient received flu vaccination on 11/3/08. Patient called the Tele-nurse line on 11/4/08 complaining of generalized itching over most of her body after receiving the flu vaccination. The itching subsided on 11/3/08 but patient developed aches all over with some chills on 11/4/08. She has taken the flu vaccination in the past without side effects. She denied any other symptoms. Nursing line referred the information to her PCP. Patient instructed to drink at least six 8-ounce glasses of fluid a day unless on a fluid restriction diet. She was also instructed to take her usual pain/fever medications as per label instructions. Patient also told to call the Tele-nurse back if symptoms did not improve by Thursday, 11/06/08, if her symptoms worsened, or if she developed new symptoms.										11/03/2008	11/04/2008	1		UNK	UNK						1						1	Chills; Pain; Pruritus generalised	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331516	11/06/2008	SC	59.0	59		F	11/05/2008	It got flu shot on 11.3.08. Later same day noticed redness close to injection site ( R arm). No increase redness x 24 hours. Skin still warm and red. Last night had fever up to 99.5 and felt little bit nausea.									U	11/03/2008	11/04/2008	1	None	OTH	PVT	fish oil, multivitamin	no acute illness	RAD, Hx of PNC allergy			1						1	Injection site erythema; Nausea; Pyrexia; Skin warm	FLU3~SANOFI PASTEUR~U2743AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331518	11/06/2008	MN	26.0	26		F	11/05/2008	Patient describes left sided aching since administration of flu mist.									U	10/21/2008	10/21/2008	0		PVT	PVT	Levothroid, orthomicronor		NKA, Hypothyroidism			1						1	Pain	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0331519	11/06/2008	NY	1.0	1	.0	F	11/06/2008	Rash over face only.									Y	10/29/2008	10/30/2008	1		PUB	PUB		None				1						1	Rash	FLU3~SANOFI PASTEUR~U2829AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1224X~1~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0331520	11/06/2008	MD	35.0	35		F	11/06/2008	Associate received flu vaccine and Hepatitis B vaccine on 11/5/08 at approximately 3:30 pm. Associate called employee health office on 11/6/08 and stated she has multiple joint and body aches including legs, ankles, arm also experienced shooting pains up and down legs and behind ear. Denies fever. States took Tylenol extra strength with no relief of aches.				Y					U	11/05/2008	11/06/2008	1		MIL	OTH	MVI	cough	Tetracycline (causes edema), Gastric bypass 04/2005			1						1	Arthralgia; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8803906~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB640AA~1~IM~LA~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0331521	11/06/2008	TX	34.0	34		F	11/05/2008	Arm pain and numbness on arm of injection site (left), described as tingling and radiating pain.									Y	11/05/2008	11/05/2008	0		OTH	PVT		None				1						1	Injection site anaesthesia; Injection site pain; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88636~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331522	11/06/2008	TX	47.0	47		F	11/06/2008	Headaches, chills, fever, running nose, cough, sneezing, severe sweating, 104 fever, sore throat, muscle aches, fatigue, ear ache, very tired, chest pain, diarrhea				Y					N	10/23/2008	10/24/2008	1		OTH	PUB	Earflex, Etodolac		Thoracic Spine, Wedge Fracture			1						1	Chest pain; Chills; Cough; Diarrhoea; Ear pain; Fatigue; Headache; Hyperhidrosis; Myalgia; Oropharyngeal pain; Pyrexia; Rhinorrhoea; Sneezing	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0331523	11/06/2008	OH	40.0	40		M	10/30/2008	Injection given into L deltoid. He is getting pain into L axilla region with lymph node pain/swelling. No skin cellulitis. Noted diagnosis: axillary lymphodenitis.									N	10/29/2008	10/29/2008	0	None	PUB	UNK		None	None			1						1	Axillary pain; Lymph node pain; Lymphadenitis; Lymphadenopathy	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89986~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331524	11/06/2008	MD	13.0	13		M	11/03/2008	Nausea/vomiting, lightheaded approx 10-15 minutes post injection. Client pale, weak, pulse weak/regular. T. 97.9 B/P 95/55, P-51 R-16. Skin cool, dry, lie down x 5-10 minutes. Set up, ate pretzels, drink water; B/P 100/65 P-48 R-16, color improved. To recheck with mother, sister under /// ///									Y	11/03/2008	11/03/2008	0	None	PUB	PUB	None	None	None			1						1	Asthenia; Blood pressure decreased; Dizziness; Feeling cold; Nausea; Pallor; Pulse pressure decreased; Vomiting	FLU3~SANOFI PASTEUR~U2806AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331526	11/06/2008	TX	40.0	40		M	11/06/2008	6 hours after vaccine administered patient began suffering from high fever, headaches, severe chills, severe body aches...all of which continued for the next 12 hours at least									U	11/05/2008	11/05/2008	0		PVT	PVT						1						1	Chills; Headache; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331527	11/06/2008	MI	39.0	39		F	11/06/2008	Approx. 24 hrs after vaccine, had symptoms that included fever, diarrhea, dizziness, weakness, fatigue, nausea.									Y	10/29/2008	10/30/2008	1		PVT	UNK		None	None			1						1	Asthenia; Diarrhoea; Dizziness; Fatigue; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331528	11/06/2008	NY	62.0	62		F	11/06/2008	Starting having itching over entire body next day after taking flu vaccine, acompanied by fine rash. Lasted 5 days resolved with using bebnadryl around clock.  No history of allergic reaction to flu vaccine in the past.									Y	10/30/2008	10/31/2008	1	none	PUB	PVT	Permarin, Centrium Silver	none	hay fever, rag weeds, dust, dirt, roses, strawberries.			1						1	Pruritus generalised; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA350CA~6~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331529	11/06/2008	NE	8.0	8		F	11/06/2008	PATIENT STOPPED IN CLINIC ON 11-5-08 WITH REDNESS ON THE LEFT DELTOID. THIS IS WHERE HE RECEIVED HIS VZV #2. REDNESS WAS 3CM BY 3CM, RAISED, AND WARM TO TOUCH.									Y	11/04/2008	11/05/2008	1	NONE	PUB	UNK	NONE	NONE	NONE			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2739AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0171X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0331530	11/06/2008	UT	30.0	30		F	11/06/2008	Felt disconnected and dizzy immediately after shot. Within 15 minutes max. labored breathing. Reported to nurse. She gave me 2 chlortimaton, no affect, gave 2 more, still no affect. Within 30 minutes of shot throat was almost completely closed and I was white, erratic blood pressure and heart rate, delirious, they gave me shot of .3 epinephrine and I could then breathe.  Ems came and stabilized me.  Went to ER where they watched me for a few hours. Released that night. Had to take almost a week off work to recover. Have had 2 follow-ups with primary md and 1 with Workcare since  this happened on my job site.  12/4/08 ER note received for DOS 10/29/08 with DX: Reaction to flu shot. Pt presented to ER following episode of lightheadedness, dizziness, SOB, feeling unwell and feeling like throat was closing up.  BP high for pt 130/80s.  Received epi with improvement noted.  PE WNL. D/C to f/u with PCP.			Y	Y					Y	10/29/2008	10/29/2008	0	EKG, pulse/oxygen saturation, glucose test, blood pressure, lungs and throat checked multiple times.	UNK	UNK	gabapentin, zoloft, seroquel, zenchent, ativan (only as needed)	none	compazine, phenergan, bactrim, septra, grapefruit. PMH: Septoplasty, breast reduction, pneumonia. allergies: Phenergan, Compazine. Septra			1						1	Blood glucose; Blood pressure fluctuation; Delirium; Dissociation; Dizziness; Dyspnoea; Electrocardiogram; Heart rate abnormal; Immediate post-injection reaction; Oxygen saturation; Pallor; Throat tightness; Blood pressure increased; Dizziness; Dyspnoea; Fatigue; Feeling abnormal; Throat tightness	FLU3~SANOFI PASTEUR~U284AC~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2849AC~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening	Influenza
0331531	11/06/2008	NJ	27.0	27		M	11/06/2008	Vaccine given at 6:45pm.  Approximately 3 hours later, began experiencing cough/wheezing.  This progressed through the night until around 4am, both eyes were very bloodshot and fluid discharge.  Also head congestion and rapid heart beat.  Took loratadine 10mg at 10:30pm.  Symptoms resolved upon waking in the morning.  This is the first time that I have had the flu vaccine.									Y	11/05/2008	11/05/2008	0		UNK	UNK		Infectious Mononucleosis 6 weeks ago.				1						1	Cough; Eye discharge; Heart rate increased; Nasal congestion; Ocular hyperaemia; Wheezing	FLUX~UNKNOWN MANUFACTURER~?~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331532	11/06/2008	NJ	40.0	40		F	11/06/2008	Diarhea, fever, chills, sweating, change of behavior (irritable), and dizziness.										10/30/2008	11/03/2008	4		PUB	UNK		None	Allergies, Sinus			1						1	Chills; Diarrhoea; Dizziness; Hyperhidrosis; Irritability; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331534	11/06/2008	WV	12.0	12		F	11/06/2008	Approximately 10 - 15 minutes after receiving her flu vaccine, which she has had yearly for at least 6 years, my daughter blacked out in the car while we were driving.  She wasn't out very long, but then reported feeling dizzy and said the trees looked blurry.  She lost all her color and became very shaky and after about 5 minutes said she was nauseous.  Within a few minutes she threw up.  We returned to the health department, where they gave her some orange juice and had her sit in a chair for about 10 minutes.  They were very kind and reassuring, but this has shaken patient up quite a bit.  She was not ill, nor was she feeling very nervous about getting a shot.  A nurse at our church said there had been a report about this happening to teenagers, so I thought you should be aware of it.									Y	11/05/2008	11/05/2008	0		UNK	UNK	Zyrtec, nightly for allergies	None	None			1						1	Dizziness; Loss of consciousness; Nausea; Pallor; Tremor; Vision blurred; Visual impairment; Vomiting	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331536	11/06/2008	NM	11.0	11		M	11/06/2008	Patient said he did not feel good around 4pm the day of vaccination. Around 9pm patient said he was hot. His face, ears, neck and shoulders were very red and hot to the touch. He was then saying he was having hot/cold flashes. He said his arms around the injections sites were hot and itching.				Y					Y	10/22/2008	10/22/2008	0		UNK	UNK	Zyrtec and Singulair	None	Asthma. Allergic to Augmentin			1						1	Erythema; Feeling cold; Feeling hot; Hot flush; Injection site pruritus; Injection site warmth; Malaise; Erythema; Feeling of body temperature change; Injection site pruritus; Injection site streaking; Injection site urticaria; Injection site warmth; Malaise; Skin warm	FLU3~SANOFI PASTEUR~U2833AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB246AA~1~IM~RA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2683AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2899AA~1~IM~LA~TDAP (ADACEL)~1|FLU3~SANOFI PASTEUR~U2833AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB246AA~UNK~IM~RA~HEP A (HAVRIX)~2|MNQ~SANOFI PASTEUR~U2683AA~UNK~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TDAP~SANOFI PASTEUR~C2899AA~UNK~IM~RA~TDAP (ADACEL)~2	USA	Emergency room visit	Influenza
0331538	11/06/2008	FL	67.0	67		F	11/06/2008	had PPV vaccine administered approx. 1:45 P.M. on 11/04/08.  At 4:30 P.M. on 11/04/08 felt arm burning, redness, red lines and horrible swelling-applied ice-couldn't move arm-wheezing and coughing. 11/05/08 emergency visit to family physician. 11/6/08 swelling has improvement but still red and hot.				Y					U	11/04/2008	11/04/2008	0		PUB	UNK						1						1	Burning sensation; Cough; Erythema; Injected limb mobility decreased; Skin striae; Skin warm; Swelling; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0331542	11/06/2008	MN	27.0	27		M	11/06/2008	Trouble breathing in the afternoon. Chest was very tight and breathing was constricted. Symptoms remained throughout the night but have started to retreat. Slight tightness of breath still remains.									N	11/05/2008	11/05/2008	0		UNK	UNK			History of asthma, but hasn't been bothered by it for years.			1						1	Chest discomfort; Dyspnoea	FLUX~SANOFI PASTEUR~62839AA~1~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331543	11/06/2008	TX	19.0	19		F	11/06/2008	PATIENTS HUSBAND CALLED THIS MORNING, STATES THE PATIENT WAS PREGNANT AT TIME OF VACCINATION, COMPLAINS OF HEADACHE AND STOMACH ACHES									U	10/23/2008	11/06/2008	14		PUB	PVT	UNKNOWN	NO	NO			1						1	Abdominal pain upper; Drug exposure during pregnancy; Headache	FLU3~SANOFI PASTEUR~AFLUA375AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0398X~1~IM~RA~HEP B (FOREIGN)~1|IPV~SANOFI PASTEUR~A0805~1~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1079X~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TDAP~SANOFI PASTEUR~C2768BA~1~IM~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~0975X~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0331546	11/06/2008	SC	34.0	34		F	11/06/2008	Woke up 3:00am on 11/01/2008 with fever.									Y	10/20/2008	11/01/2008	12		UNK	PUB	Armour 30mg					1						1	Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~3~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331550	11/06/2008	CA	59.0	59		F	11/06/2008	patient called in day after injection stating her arm ached from left shoulder to left elbow ( felt like I had been slugged in my arm) 2 hours after receiving injection and that today she had a sore throat and fatigue. denies fever.									U	11/05/2008	11/05/2008	0		UNK	UNK	metformin	Diabetes				1						1	Fatigue; Oropharyngeal pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA172AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331551	11/06/2008	IA	70.0	70		M	11/06/2008	PT. RECEIVED VACCINATION ON 10/22/08. CALLED PHARMACY ON 10/23/08 AND STATED THAT THEY HAD PAIN AT INJECTION SITE AND REDNESS DOWN TO ELBOW AREA. PHARMACIST INSTRUCTED TO KEEP AN EYE ON IT FOR A DAY OR TWO AND TO REPORT IF THE REACTION DIDN'T RESOLVE IN A COUPLE DAYS.  PT. ENDED UP GOING TO DOCTOR ON 10/27/08 FOR TREATMENT AND RECEIVED ANTIBIOTIC FOR INFECTION.  PT REPORTED LATER IN THE WEEK THAT THE PAIN AND SITE WERE IMPROVING WITH CONTINUED ANTIBIOTIC TREATMENT.				Y					Y	10/22/2008	10/23/2008	1		UNK	PVT		NONE	COPD			1						1	Infection; Injection site erythema; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89622~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0331553	11/06/2008	PA	3.0	3		F	11/06/2008	SO FAR, SHE HAS HAD NONE									U	11/06/2008	11/06/2008	0	NONE AS OF YET	PUB	UNK	NONE	HERE FOR FLU SHOT ONLY	NONE			1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA375AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331555	11/06/2008	AZ	4.0	4		F	11/06/2008	11/4/08 - Redness on left arm at injection site.  11/5/08 - Left arm from shoulder to elbow red, warm to touch.  Also, complaints of tiredness; no fever									U	11/03/2008	11/04/2008	1	none	PUB	PUB		none known	none known			1						1	Fatigue; Injection site erythema; Skin warm	DTAP~SANOFI PASTEUR~AC14B064AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U28660AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHZVB245AA~1~IM~RA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~A1060~5~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0914X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0789X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0331557	11/06/2008	FL	65.0	65		F	11/06/2008	Received influenza and pneumonia vaccine on 11/04/08.  Left forearm pneumonia site and red and warm to touch.  Redness and warmth has radiated to posterior area.  Has applied ice packs but very painful.  Physician referred to hospital ER to evaluate possibility of cellulitis.  Reports problem started immediately after receiving injection.				Y					U	11/04/2008	11/04/2008	0		PUB	PUB		None	Allegra and Codeine			1						1	Immediate post-injection reaction; Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~u2744aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~072x~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331558	11/06/2008	TN	60.0	60		F	11/06/2008	Received Tdap and flu vaccine in left arm per patient request. Patient states arm was sore and a little swollen on day of injection(11/04/08). The next morning when she woke up (11/05/08) she noticed a bruise at the injection site and her arm was swollen and painful to touch.  This morning she said it turned red and hot.  Patient instructed to apply ice packs to area. Take tylenol prn fever and/or swelling.  Take Benadryl prn itching.  Pt also instructed to follow up with PMD if s/s get worse.  Pt instructed to call prn if questions/concerns.  If patient experiences difficulty breathing call 911.  Pt informed that agency will follow up with her.									U	11/04/2008	11/04/2008	0		PUB	UNK			Borderline diabetic- tx with Metformin and Actos			1						1	Erythema; Injection site haematoma; Oedema peripheral; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~U2770AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2773BA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0331559	11/06/2008	MA	21.0	21		F	11/06/2008	Influenza vaccine given SC, not IM.  Member experienced erythema, swelling, heat 2.5 x 1. Member reported pain and itching at injection site.  Duration of symptoms- 72hrs.									Y	11/02/2008	11/02/2008	0	N/A	MIL	MIL	BCP	NONE	NKDA, NKA, NO Hx			1						1	Incorrect route of drug administration; Injection site erythema; Injection site pain; Injection site pruritus; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLS192AA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331560	11/06/2008	FL	26.0	26		F	11/06/2008	Coworker and I were administered flu shot on 10/22/08.  From what I read, symptoms should not be occuring, but both of us are experiencing the same symptoms:  flu like symptoms, fatigue, sore throat, dry cough, slight fever.  Both of us just do not feel well and normally do not fall ill.  No one else in the office has received the shot or nasal spray, has fallen ill, or become infected by either of us.  Also, site of injection was usually sore compared to the previous 5 years I have received the flu shot.									Y	10/22/2008	10/24/2008	2		PVT	UNK		none	none			1						1	Cough; Fatigue; Influenza like illness; Injection site pain; Malaise; Oropharyngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331561	11/06/2008	MI	71.0	71		F	11/06/2008	11/06/2008  Pt. States started itching on head then noticed on shoulder and breast area 6 hours after receiving the Flu shot. Also took Naprosyn.  States called PMD and was told to take Benadryl, 50mg. States it was effective, the next day started again 3 hours after taking Naprosyn.  States was told by PMD that she should probably not receive flu shots anymore.				Y					Y	10/29/2008	10/29/2008	0	None	PUB	PVT	Naprosyn	none, Naprosyn for bone spur	Has heart stents			1						1	Pruritus	FLU3~SANOFI PASTEUR~U2811AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331563	11/06/2008	MA	25.0	25		F	11/06/2008	Influenza vaccine given SC instead of IM.  Member experienced slight redness, itching and soreness at injection site for app. 48 hours.									Y	11/02/2008	11/02/2008	0	N/A	MIL	MIL	NONE	NONE	NKDA, NKA, NO Hx			1						1	Incorrect route of drug administration; Injection site erythema; Injection site pain; Injection site pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA192AA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331565	11/06/2008	OH	5.0	5		M	11/06/2008	3 days following administration of vaccine vomited x 2-3 days.									Y	10/22/2008	10/25/2008	3		PVT	PVT	None	URI	multiple food allergies			1						1	Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500544P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0331567	11/06/2008	MO	73.0	73		M	11/06/2008	swelling,redness,warmth and pain to touch x1 day in rt upper deltoid and down to posterior/ antrior bicept.				Y					Y	10/30/2008	10/30/2008	0		MIL	MIL	cephalexin, acetominophen, metoprolol, hctz, vardenafil, amlodipine, simvastatin, chlordiazepoxide	fungal infection of the right big toenail	s/p mi and angioplasty			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88132~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0983X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331568	11/06/2008	MN	3.0	3		F	11/06/2008	Went to give the child the flumist (nasal), and child jolted head back as spraying - small amount of flumist sprayed into child's eye.  We immediatelty flushed with water.  Patient did not have any effects.									Y	11/06/2008	11/06/2008	0		PUB	PUB						1						1	Accidental exposure	FLUN3~MEDIMMUNE VACCINES, INC.~500569P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0331569	11/06/2008	GA	5.0	5		F	11/06/2008	Large area of erythema, warmth-measures 8by7.5 cm today.										11/04/2008	11/05/2008	1	None	UNK	UNK		None	None			1						1	Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~u2763aa~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331572	11/06/2008	CO	71.0	71		F	11/06/2008	PATIENT RECEIVED TDAP INJECTION ON 10/23/08.  PT STATED SHE HAD NO PROBLEMS UNTIL 11/01/08 WHEN SHE NOTICED THE INJECTION SITE WAS RED/PURPLE WITH SMALL WHITE SPOTS ON IT.  PT STATED THAT SHE NEVER FELT ANY PAIN/DISCOMFORT ASSOCIATED WITH IT.  SHE RETURNED TO CLINIC ON 11/04/08 TO HAVE THE AREA LOOKED AT AND AT THAT TIME, THE INJECTION SITE AREA WAS SLIGHTLY PINK APPROXIMATELY 1 INCH IN DIAMETER AND WAS NOT WARM TO THE TOUCH.  PT STATED THAT IT WAS GREATLY IMPROVED FROM 11/01/08.  CALLED PT TODAY, 11/06/08, AND PATIENT REPORTS THE AREA IS BACK TO NORMAL.									Y	10/23/2008	11/01/2008	9	NA	PVT	PVT	DIOVAN 160MG ONCE A DAY, OMEPRAZOLE 20MG ONCE A DAY, AVELOX 400MG ONCE A DAY, ADVAIR DISCUS 250/50 INHALER TWICE DAILY		UNSPECIFIED ESSENTIAL HYPERTENSION, HYPOTHYROIDISM, MYALGIA.  ALLERGIES: CEPHALOSPORINS, MACROLIDES			1						1	Injection site discolouration; Injection site erythema	FLU3~SANOFI PASTEUR~U2745AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C3027AA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0331574	11/06/2008	WA	5.0	5		F	11/06/2008	RA,presumed site of varicella vaccine administration 11/03/2008, shows erythematous  area, sl textured, warm to touch, 60mm high X 50 mm across, noted last evening initially.  Guardian states it was firmer, and more swollen last pm.  Child is afebrile, normal activity level.  Incidental is 15 mm bruise noted in R deltoid area:  dtap and influenza vaccine were administered to RD on same day.									U	11/03/2008	11/05/2008	2		PUB	PUB	none	none	none			1						1	Injection site erythema; Injection site haematoma; Injection site induration; Injection site swelling; Injection site warmth	DTAP~SANOFI PASTEUR~C2935AA~5~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2808AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0342-2~4~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1313U~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1994U~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0331575	11/06/2008	CA	57.0	57		F	11/06/2008	10/31 3pm malaise, lo graade fever, nausea, fatique 11/2 AM rash on left side of back spreading to side to groin, lymph nodes swelling and pain.  11/3 Dr visit dx with shingles due to immune supression effect of flu vaccine, at which time I was prescribed Acyclovir.				Y					Y	10/31/2008	10/31/2008	0	None	PVT	PVT		No	Sulfa			1						1	Fatigue; Herpes zoster; Immune system disorder; Lymph node pain; Lymphadenopathy; Malaise; Nausea; Pyrexia; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89977~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0331576	11/06/2008	VA	37.0	37		F	11/06/2008	One day after I received the flu shot, I have had a fever.  The fever starts in the afternoon and lasts 5 or 6 hours.  The fever ranges from 99 ot 101.									N	10/17/2008	10/18/2008	1		UNK	UNK	Noe	None	None			1						1	Pyrexia	FLU3~SANOFI PASTEUR~u2771aa~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331577	11/06/2008	CA	11.0	11		M	11/06/2008	Per mom, hives that started on chest (avoiding the nipple area), back, stomach and shoulders.  Took child to emergency room and given epinepherine, steroids and benadryl.  No breathing difficulties noted. Hives subsided with treatment.  Next morning, hives on shoulders,neck, face, pelvic area, thighs and legs.  Taken to pediatrician.  Given prednisone and atarax for the itching.  Pediatrician described the rash as moderately severe urticaria covering most of his body.  Symptoms started approximately 3-4 hours after receiving first dose of FluMist.				Y					Y	11/04/2008	11/04/2008	0	None known.	UNK	PUB	None	None	None	no~ ()~NULL~~In Patient|no~ ()~NULL~~In Sibling1		1						1	Pruritus; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500560P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0331587	11/06/2008	MA				F	11/06/2008	This case was reported by a pharmacist and described the occurrence of hearing loss in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL at 0.5 ml. At an unspecified time after vaccination with FLULAVAL, the subject experienced hearing loss. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.									U				UNK	OTH	OTH		Unknown	The subject has no history of reactions with previous flu shots.		A0755266A	1						1	Deafness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA021AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331591	11/06/2008	MI	48.0	48		F	11/06/2008	Severe headache, skin and joint aches, swelling everywhere, could not walk or sit, Lupus attack									Y	11/04/2008	11/05/2008	1		PVT	PVT		HA, sinus congestion, cough dx sinusitis				1						1	Arthralgia; Gait disturbance; Headache; Skin discomfort; Swelling; Systemic lupus erythematosus	FLU3~SANOFI PASTEUR~U2746AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331592	11/06/2008	AK	33.0	33		M	11/04/2008	10/30 Pt states started to develop hives at waist/wrists bil and L leg at 0830 24 hours after flu immunization. No local reaction. Benadryl given 1500 10/30/08. On 10/31 Pt states hives spread to most of body then resolved by 11/1.									Y	10/29/2008	10/30/2008	1		OTH	PUB	None	None	Nuts, fish, Percocet			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2829AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331594	11/06/2008	IL	2.0	2	.0	F	11/05/2008	Nasal congestion/rhnitis onset evening after flu mist. Seen 10-9 with persistent congestion, wheezing and evidence bilat OM									Y	10/02/2008	10/09/2008	7		PVT	UNK		None	None			1						1	Nasal congestion; Otitis media; Respiratory tract congestion; Rhinitis; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500541P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0331595	11/06/2008	CA	47.0	47		F	11/06/2008	Red, puffy, swollen eyes. Start of symptoms 2 hours later and abated 24 hours later. No treatment other than cool water splashed in eyes.									Y	11/04/2008	11/04/2008	0	None	UNK	UNK						1						1	Eye swelling; Ocular hyperaemia	FLU3~SANOFI PASTEUR~U2767AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331596	11/06/2008	WI	53.0	53		F	11/04/2008	Injection @ 1050. Started feeling nasal congestion @ approx 1700, feeling of scratchy throat and feverish. Took a vitamin @ 1730, returned to work and became hoarse, but felt better. Co-worker noticed blood shot eyes @ approx 2000. At approx 2100 no new symptoms, but pt had difficulty taking a deep breath in which had improved from 3 hrs previously. Arrived in ER @ 2115 noted to have high blood pressure. Received Benadryl injection which caused pt to feel worse, however the voice returned spontaneously. Illness deemed viral and pt sent home. Pt felt fine //// No other symptoms.				Y					Y	11/03/2008	11/03/2008	0		UNK	UNK		None	None			1						1	Dysphonia; Dyspnoea; Hypertension; Nasal congestion; Ocular hyperaemia; Pyrexia; Throat irritation; Viral infection	FLU3~SANOFI PASTEUR~U2766AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331597	11/06/2008	WI	20.0	20		F	11/04/2008	Injection @ 1600. At approx 1830 Pt felt very hot and sweaty, hands shaky, and sensation of inability to take a deep breath with spontaneous cough. Evaluated by factory first aid attendant and taken to ER @ 2115. Received injection of Benadryl in ER. No relief from this. Pt then went home @ 0000 and vomited at home, symptoms then subsided. Pt went to bed @ 0115 and woke up feeling fine.				Y					Y	11/03/2008	11/03/2008	0	None	PVT	PVT	None	None	Bee stings			1						1	Cough; Dyspnoea; Feeling hot; Hyperhidrosis; Tremor; Vomiting	FLU3~SANOFI PASTEUR~U2766AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331599	11/06/2008	PA	7.0	7		F	11/06/2008	Syncope - occur approximately 5 min after getting the vaccine below									Y	11/05/2008	11/05/2008	0		PVT	UNK	None	None	None	syncope~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Immediate post-injection reaction; Syncope	FLU3~SANOFI PASTEUR~U2740AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331600	11/06/2008	OH	7.0	7		M	10/29/2008	Hives covering body with pruritus for 2 days. Treated with Benadryl. No shortness of breath.									Y	10/27/2008	10/28/2008	1	None	PVT	PUB	None	None	None			1						1	Pruritus; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500558P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHARB247AA~1~UN~LL~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~0533X~2~UN~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0331601	11/06/2008	IN	49.0	49		F	11/05/2008	Pale, Tremors, SOB									Y	10/31/2008	10/31/2008	0		UNK	UNK	CLARITAN					1						1	Dyspnoea; Pallor; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89973~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331602	11/06/2008	VA	0.6	0	.6	M	11/06/2008	Fever and rash approximately 5 hrs after injection. Treated fever with Tylenol, skin reaction with oral Benadryl.									N	11/03/2008	11/03/2008	0	CBC/Blood culture, CPR, urine culture done to, eval for sepsis/other source of fever in infant	PUB	PUB	None	None	None - SVT at birth - resolved spont - no chronic cardial problems			1						1	Blood culture; Culture urine; Full blood count; Pyrexia; Rash	FLU3~SANOFI PASTEUR~UT2788GA~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331580	11/07/2008					U	11/07/2008	mild rash									Y	10/28/2008	10/28/2008	0		UNK	UNK			NKDA			1						1	Rash	FLU3~SANOFI PASTEUR~ut2788IA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB289aa~UNK~IM~~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~0736x~UNK~IM~~VARICELLA (VARIVAX)~1	USA		Influenza
0331611	11/07/2008	IL	34.0	34		F	10/28/2008	This case was reported by a healthcare professional and described the occurrence of fever in a female subject aged between 40 and 49 years old who was vaccinated with influenza vaccine TRIVALENT (FLULAVAL, GlaxoSmithKline), pneumococcal vaccine, unspecified (Pneumovax, Merck) and tetanus and diphtheria toxoids adsorbed (Tetanus diphteria vaccine, Sanofi Pasteur) for prophylaxis. On an unspecified date in September 2008, the subject received an unspecified dose of FLULAVAL (.5 unknown, unknown), an unspecified dose of Pneumovax (unknown), and an unspecified dose of Tetanus diphteria vaccine (unknown). At an unspecified time after vaccination with Flulaval, Pneumovax and Tetanus diphteria vaccine, the subject experienced fevers of over 102 degrees Fahrenheit during the next five days. The subject treated her symptoms at home, but was seen in the physician's office for a follow-up. At the time of reporting, the event was improved. Follow-up information received on 07 October 2009 indicated that the subject was 34 years old at the time of event. Onset of fever was 13 September 2008 and on an unspecified date, the event resolved. The subject never received Tetanus diphteria vaccine, it was recorded in error, and Flulaval and Pneumovax were given in the same unknown arm.									Y	09/01/2008	09/13/2008	12	Body temperature - Sep2008 - 102+ degrees Fahr	PVT	PVT		Unknown	A0748888A was one of two cases reported by the same healthcare professional. A nurse reported that two female subjects in their 40's received Flulaval, Pneumovax, and tetanus diphteria vaccines during the same office visit. Both subjects experienced fevers of over 102 degrees Fahrenheit in the next five days following the vaccinations. Both subjects treated their symptoms at home, but were seen in the physician's office for follow-up. Please reference report A0748893A for further information.		A074888A	1						1	Body temperature increased; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA171AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1960U~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331646	11/07/2008	NC	6.0	6		M	10/27/2008	Large local reaction - Red, swollen, warm area involving entire R anterior thigh from just below hip to just above knee. Treated with cool compresses and BENADRYL, resolved approximately in 72 hours. All began approximately 2-3 hr after receiving flu vaccine at that location.									Y	10/22/2008	10/23/2008	1		PVT	PUB						1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2848AA~5~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB291AA~2~IM~LL~HEP A (HAVRIX)~1	USA		Influenza
0331647	11/07/2008	KY	5.0	5		F	10/29/2008	Vomiting, hives itching				Y					Y	10/20/2008	10/22/2008	2		OTH	OTH						1						1	Pruritus; Urticaria; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0331649	11/07/2008	VA	64.0	64		F	11/04/2008	Redness, painful hard lump with Pneumovax. Slowly improving over 1 wk.									Y	10/27/2008	10/27/2008	0		PVT	PVT	Crestor, Allegra-D, Ditropan	None	None			1						1	Injection site erythema; Injection site mass; Injection site pain	FLU3~SANOFI PASTEUR~U2765AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1679U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331650	11/07/2008	IN	3.0	3		M	11/02/2008	No symptoms until 9:00 PM. Left cheek broke out into red/white, thick and bumpy hives. He complained that his left eye hurt. At 9:15 the hives quickly spread to his forehead, the right side of his face, and both eyelids. We took him to the hospital at 10:30 (arrived there). The hives became worse and his left eye was completely swelled shut. There were tiny red dots on his arms and back, some on front of neck. My son also had a cough along with all of this. After he was given a steroid shot and Benadryl, the hives went away within the hour and his swelling went down some. The swelling was not gone until Sat. afternoon. The swelling covered his entire face, not just his eyes. When we got home, we gave him Benadryl every 6 hrs. Prednisolone 2 times a day and eye ointment 4x day.				Y					Y	10/30/2008	10/30/2008	0	Normal heartbeat, breathing. No lab work was done. Throat not swollen.	PVT	OTH	None	None	None			1						1	Cough; Erythema; Eye pain; Eye swelling; Rash erythematous; Swelling face; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500567P~1~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0331651	11/07/2008	WV	9.0	9		F	10/27/2008	Nausea and vomiting following administration approx. 30 mins after the administration S/SX started. Lasted approx 2 hrs. During the first 30 mins she also c/o difficulty breathing. No action taken by Mom for this.									Y	10/23/2008	10/23/2008	0	None	PVT	PUB		None	Seasonal Allergies and Asthma			1						1	Dyspnoea; Nausea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500555P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0331653	11/07/2008	LA	2.0	2	.8	F	10/31/2008	Generalized urticarial rash. BENADRYL, PRELONE, ZANTAC, and ALLEGRA. Spoke to mother today 10/31/08 who states that child is better.									U	10/27/2008	10/30/2008	3	10/30/08, CBC, results WNL	PVT	PUB	None	None	None			1						1	Full blood count normal; Rash generalised; Urticaria	FLU3~SANOFI PASTEUR~UT2792EA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB207BA~1~IM~LL~HEP A (HAVRIX)~1	USA		Influenza
0331655	11/07/2008	CA	66.0	66		M	10/31/2008	One day after flu shot I became very depressed not even being able to respond to any questions my wife asked me. This lasted most of that day. Two days after shot, I was nearly unable to walk for several days due to severe back pain. I had to walk with two canes.									Y	10/23/2008	10/24/2008	1	None	OTH	OTH	Lisinapril, Coreg, Ritalin, Lipitor, Trasadone, Tranadol, Warfarin, Colestid, Tylenol, Effexor-SR	None				1						1	Abasia; Back pain; Depression; Walking aid user	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331656	11/07/2008	WI	12.0	12		M	11/03/2008	RN inadvertently administered DTaP instead of Hep A #1. RN- 1) Notified Medicine Director 2) Client's Physician 3) Parents of child  11/3/08 No adverse events reported by mother.									Y	10/30/2008				PUB	PUB						1						1	No adverse event; Wrong drug administered	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B064AA~6~IM~LA~DTAP (INFANRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500547P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TDAP~SANOFI PASTEUR~C3027AA~1~IM~RA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1221X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0331657	11/07/2008	MA	61.0	61		F	11/03/2008	Pt. complains of pain, unable to lift arm, redness swelling warm to the touch.  Started later that day and last 3 days.  No treatment given.									Y	10/28/2008	11/03/2008	6		PVT	PVT		None	Allergies to ace inhibitors			1						1	Erythema; Injected limb mobility decreased; Oedema peripheral; Pain in extremity; Skin warm; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA154AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0555U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331658	11/07/2008	MA	48.0	48		F	11/03/2008	Pt complained of redness, swelling, warm to the touch and pain in the arm where injection was given for about 3 days. No treatment given.									Y	10/23/2008	10/24/2008	1		PVT	PVT		None	allergies to sulfa and codeine			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA154AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331660	11/07/2008	WA	48.0	48		M	10/30/2008	Left arm feels numb like asleep, lasts for minutes 10-12 times a day.  dorsal arm, multiple denuatunes treatments wait & watch										10/06/2008	10/16/2008	10		UNK	UNK		None	Kidney stones, migraine headaches			1						1	Hypoaesthesia; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331662	11/07/2008	NC	6.0	6		M	10/31/2008	Redness and induration and warmth at injection site. > 8 cm									Y	10/28/2008	10/28/2008	0		PVT	UNK		None	grass allergies			1						1	Injection site erythema; Injection site induration; Injection site warmth	FLU3~SANOFI PASTEUR~U2809AA~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331663	11/07/2008	NC	0.7	0	.7	M	11/03/2008	Child presented to clinic 4 days after getting flu vaccine with hives 4 hours after vaccine was administered. Nurse practitioner gave child Zyrtec and Zantac and told to take until hives go away.				Y					Y	10/31/2008	10/31/2008	0		PUB	PUB						1						1	Urticaria	FLU3~SANOFI PASTEUR~UT2797FA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331664	11/07/2008	MA	36.0	36		U		Received flu vac received 10/28/08 1912 L deltoid T max 38.5 red, warm to touch, rash that came to expand x 24 hours. PO keflex d\c, then Vancomycin x 2 doses then Bactrim DS.										10/28/2008				PVT	UNK		Depression with SI	Allergic to latex			1						1	Body temperature increased; Rash; Skin warm	FLU3~SANOFI PASTEUR~B22494A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~9722106~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331672	11/07/2008	IA	39.0	39		F	11/06/2008	Facial numbness w\drooping. Bells palsy. Predisone/CT scan.  11/14/08 Reviewed PCP medical records of 9/11-11/06/2008. FINAL DX: Bell's palsy Records reveal patient experienced intermittent redness & inflammation of conjunctivae bilaterally.  Right calf also swollen & painful w/equivocal Homan's.  Referred to ophtho & vein center.  RTC 11/1/08 w/numbness/tingling left face w/HA x 2 days.  Tx w/steroids.				Y					U	10/22/2008	11/01/2008	10	Lyme disease/sed rate   LABS: CBC & chemistry WNL.	PVT	PVT	no	None	Allergy to Biaxin and Augmentin - Rash   PMH: migraine, venous insufficiency, right knee arthritis, chicken pox, herpes zoster.		IA08015	1						1	Borrelia burgdorferi serology; Facial palsy; Hypoaesthesia facial; Red blood cell sedimentation rate	FLU3~SANOFI PASTEUR~U2763AA~5~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331673	11/07/2008	IA	42.0	42		F	11/06/2008	Facial droop. Bells palsy Famciclovir 750 mg TID x 7 days predisone 60mg PO x 7 days, Neurontin 300 mg x 10 days.  11/25/08 Reviewed PCP medical records of 10/29-11/5/2008. FINAL DX: Bell's palsy Records reveal patient experienced right facial droop, HA, shooting pain in throat. Exam noted droop of right mouth & eyelid, decreased smile on right.  Tx w/antiviral & steroids & neurontin for pain.				Y					Y	10/27/2008	10/29/2008	2		PUB	PVT	None	None	None		IA08016	1						1	Facial palsy	FLU3~SANOFI PASTEUR~U2770AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331675	11/07/2008	VA	26.0	26		U	11/07/2008	Received 3 influenza vaccines (1988,1994, 1997 dates unknown). 1988 mild pruritis; 1994 pruritic hives to body; 1997 resp distress, red hives, fatigue, wheezing, difficulty breathing tx'd with pred, inhaler, antibiotic after dx changed to pneumonia. Symptoms: Dyspnea (shortness of breath), Wheezing, Hives, Pruritus.				Y						10/01/1988			None preformed	UNK	UNK	none	None	None			1						1	Dyspnoea; Fatigue; Pneumonia; Pruritus; Respiratory distress; Urticaria; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0331677	11/07/2008	PA	55.0	55		F	11/07/2008	3 hours after administration of flu vaccine, patient developed sudden onset cough, chest congestion, swollen cervical lymph nodes and hives. She took Alavert antihistamine and about 3 hours later, awoke with a swollen tongue. The tongue swelling and rash had resolved by the time the patient called our office the day after her reaction.									Y	11/06/2008	11/06/2008	0	None done as event reported following resolution of most symptoms.	PVT	PVT	Unknown	None	PATIENT DENIED ANY EGG ALLERGY OR REACTION TO PREVIOUS FLU VACCINE.			1						1	Cough; Lymphadenopathy; Rash; Respiratory tract congestion; Swollen tongue; Urticaria; Cough; Lymphadenopathy; Pulmonary congestion; Rash; Swollen tongue; Urticaria	FLU3~SANOFI PASTEUR~U2771AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2771AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0331677	11/07/2008	PA	55.0	55		F	11/07/2008	3 hours after administration of flu vaccine, patient developed sudden onset cough, chest congestion, swollen cervical lymph nodes and hives.  She took Alavert antihistamine and about 3 hours later, awoke with a swollen tongue.  The tongue swelling and rash had resolved by the time the patient called our office the day after her reaction.									Y	11/06/2008	11/06/2008	0	none done as event reported following resolution of most symptoms	PVT	PVT	UNKNOWN	NONE	PATIENT DENIED ANY EGG ALLERGY OR REACTION TO PREVIOUS FLU VACCINE.			1						2	Cough; Lymphadenopathy; Rash; Respiratory tract congestion; Swollen tongue; Urticaria; Cough; Lymphadenopathy; Pulmonary congestion; Rash; Swollen tongue; Urticaria	FLU3~SANOFI PASTEUR~U2771AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2771AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0331678	11/07/2008	NH	10.0	10		M	11/07/2008	Urticaria on back, upper extremities, abdomen. Treated with topical aloe/calamine (no antihistamine, per pharmacist, because pt on stimulants.									Y	11/06/2008	11/06/2008	0		PUB	PUB	Albuterol, Flovent prn, Seroquel, trazodone, Ritalin, metformin.	None	Reactive airway disease, obesity, hyperlipidemia, sickle traits.			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2791DA~7+~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331679	11/07/2008	IN	9.0	9		F	11/07/2008	Pt received Flumist on 11/04/08. On 11/7/08 pt presented to urgent care with cough and wheezing.									Y	11/04/2008	11/07/2008	3		PVT	PUB		None noted	None			1						1	Cough; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500561~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0331681	11/07/2008	NC	11.0	11		F	11/07/2008	Patient was given Pediarix instead of Tdap										10/29/2008	10/29/2008	0		PVT	PUB						1						1	Wrong drug administered	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B149AA~1~IM~LA~DTAP + HEPB + IPV (PEDIARIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500548P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~1015X~UNK~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0331686	11/07/2008	CT	23.0	23		F	11/07/2008	Developed a slight fever and weakness as well as headaches.									U	11/06/2008	11/06/2008	0		PUB	UNK	Paxil, Ortho-tricycline					1						1	Asthenia; Headache; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331687	11/07/2008	NY	47.0	47		M	11/07/2008	6 hours after getting the flu shot I Developed a fever that rose to 103 degrees. I had difficuly breathing and my heartrate was faster than normal and I was wheezing.									Y	11/06/2008	11/06/2008	0		PUB	PVT	chantix	None	None			1						1	Dyspnoea; Heart rate increased; Pyrexia; Wheezing	FLU3~SANOFI PASTEUR~U2768AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331688	11/07/2008	TN	67.0	67		F	11/05/2008	Pt states had vaccinations on 10/29/08. Pneumonia and Flu vaccine on the Right arm and Td on the left arm. On 11/04/08 in the afternoon pt states left arm started itching.  That evening pt noticed that left arm was red, swollen, warm to touch, hurting and with a rach.  On 11/05/08 pt calls the clinic with above complaints.  Advised pt to come to the clinic for further evaluations.  On evaluation it was found that arm was red, swollen (area of 6x3 inches with a 3mm elevation), warm to touch, itching and painful.  Small milia-like shape pumps were also noticed.  Pt was advised to place cold compresses on the arm, take benadryl for itching and tylenol for the pain.  Also advised pt that if symptoms got worst to go to ER.									U	10/29/2008	11/04/2008	6		PUB	PUB			Allergic to codeine, Hyperlipidemia, reflux, cervicitis			1						1	Erythema; Oedema peripheral; Pain in extremity; Pruritus; Rash; Skin warm; Erythema; Oedema peripheral; Pain in extremity; Pruritus; Rash; Skin warm	FLU3~SANOFI PASTEUR~u2772aa~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0038u~2~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~u2349cb~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U2772AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0038U~2~IM~RA~PNEUMO (PNEUMOVAX)~2|TD~SANOFI PASTEUR~U2349CB~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~2	USA		Influenza
0331690	11/07/2008	GA	33.0			F	11/07/2008	Patient received Fluzone Lot u2768aa on Wednesday 11/5/08 about 9 AM.  She began to experience fatigue, body aches and pains, bright red eyes with burning, fever, and at 2 pm lung tightness. She went to bed at 7 pm, experiencing a headache about 9 pm.  Thursday am she felt better but still had bright red eyes.  She suspects ocular respiratory syndrome									Y					UNK	UNK						1						1	Chest discomfort; Eye irritation; Fatigue; Headache; Ocular hyperaemia; Pain; Pyrexia	FLU3~SANOFI PASTEUR~u2768aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331693	11/07/2008	MO	57.0	57		F	11/07/2008	10/9/08 onset facial swelling and numbness affecting jaw, parotid, and cheek area.  Seen by Urgent Care phys and referred to EENT. Tx w/ antibx and prednisone w/o results. CT scan neg. Swelling and numbness persist.				Y					U	10/08/2008	10/09/2008	1		PUB	UNK	Nitrofurantoin		Bladder infection, seasonal allergies			1						1	Computerised tomogram normal; Hypoaesthesia facial; Swelling face	FLU3~SANOFI PASTEUR~U2765AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331694	11/07/2008	MN	50.0	50		F	10/14/2008	noticed a sensation of a film over my eves.  L eye is fine (11/6) but R eye feels like there's a contact lens in my eye.  seems to be resolving.  No treatment.  Is wondering if this is a potential side effect									U	10/14/2008	10/14/2008	0		PVT	PVT		none reported				1						1	Inappropriate schedule of drug administration; Vision blurred	FLUN3~MEDIMMUNE VACCINES, INC.~500543P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0331696	11/07/2008	VA	60.0	60		F	11/04/2008	Patientdescribed fever, chills, blah feeling, loss of appetite that developed around 6pm 11/4/08 in a phone call to pharmacist on 11/5. I tried to follow up on 11/6 & she returned my call 11/7 in am. She is still having cold symptons but is feeling better. Also reported to me that her eyes became red in the pm on 11/4.									U	11/04/2008	11/04/2008	0		UNK	UNK	NOT KNOWN	None reported	Macrodantin allergy			1						1	Anorexia; Chills; Feeling abnormal; Nasopharyngitis; Ocular hyperaemia; Pyrexia	FLU3~SANOFI PASTEUR~U2741AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331700	11/07/2008	NY	8.0	8		M	11/07/2008	rednesss & swelling approximate size of golf ball at injection site, accompanied by moderate soreness				Y						11/04/2008	11/04/2008	0		PVT	UNK		none	none			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~unknown~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331702	11/07/2008	NJ	21.0	22		M	11/07/2008	Patient developed fever, headache, sore throat and myalgias 4 hours after receiving Inactivated Influenza Vaccine. Evaluated the following day.  Physical exam was within normal limits except for fever of 101.  Seen 1 day later with continued fever and intense headache. Referred to the Emergency Department for further evaluation				Y					N	11/05/2008	11/05/2008	0	Throat Culture; nasal washings No results yet	PVT	UNK	None	None	None			1						1	Culture throat; Headache; Myalgia; Nasal aspiration; Oropharyngeal pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA388BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0331703	11/07/2008	PA	55.0	55		M	11/07/2008	Injection site pain 7 days. Patient c/o joint pain statesfuzzy feeling, difficulty concentrating, congested sinus, dull head throb, and fatigue onset 24 hours after receiving vaccine.									Y	10/14/2008	10/15/2008	1		MIL	MIL						1						1	Arthralgia; Disturbance in attention; Fatigue; Feeling abnormal; Headache; Injection site pain; Sinus congestion	FLU3~CSL LIMITED~01449111A~7+~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0331704	11/07/2008	NE	80.0	80		F	11/07/2008	Patient reports a lot of itching in her L upper arm after the injection.  She noted pain and swelling in her L upper arm when she got home from her MD appt.  Morning of 11/6 pt noticed the redness was going past her elbow, MD recommended inpatient admission for IV antibiotic treatment.  Pt reports no hx of reaction to any vaccines in the past.  12/02/08 Reviewed hospital medical records of 11/06-11/10/2008. FINAL DX: acute LUE cellulitis vx immunologic reaction to pneumovax; sudden onset tachycardia & SOB; HTN; acute left parotitis secondary to dehydration & dry mouth secondary to benadryl. Records reveal patient experienced left arm spreading redness, itching, swelling & pain, nausea, malaise, HA s/p pneumovax injection in LA & flu injection RA.  No reaction to prior vaccinations w/pneumovax, flu or any other vaccines.  Tx w/IV antibiotics.  ENT consult done for left parotitis.  Improved & d/c to home on continued oral antibiotics.					Y	5			U	11/05/2008	11/05/2008	0	LABS: CBC, chemistry WNL.  CRP 56.8(H).  CTA of chest essentially WNL.  US of bilateral LEs WNL.	MIL	UNK			PMH: HTN, vertebral compression fractures, rotator cuff injury.  Allergy: codeine, feldene & ASA.			1						1	No reaction on previous exposure to drug; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1161X~UNK~~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0331705	11/07/2008	FL	46.0	46		M	11/07/2008	I developed severe chills, fever up to 102.2 (oral) diffuse myalgias, headache, and fatigue. I still have all of these symptoms now and I'm taking ibuprofen to help.									U	11/02/2008	11/05/2008	3		MIL	MIL						1						1	Chills; Fatigue; Headache; Myalgia; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0331706	11/07/2008	MS	32.0	32		M	11/07/2008	On Nov. 6th I was administered the flu vaccine at my job....It was given to me around 6:30am..around 3:30pm - 4:30pm I started breaking out in sweat. I was hot then cold...My teeth was knocking I was so cold. My temp. got up to 101 before I started taking tylenol. The symptoms last about 3:30pm til about 8:30pm when I finally feel asleep. I felt awful. My wife tells me I was having a diffcult time breathing in my sleep.									Y	11/06/2008	11/06/2008	0		UNK	UNK			Cancer, Asthma			1						1	Chills; Dyspnoea; Feeling abnormal; Feeling of body temperature change; Hyperhidrosis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331707	11/07/2008	FL	30.0	30		F	11/07/2008	Approx. 30 mins after receiving the flu shot, pt. reported pain and numbness in L arm, fingers, and hand.  Pt also fely VERY dizzy & light headed, to the point of nearly blacking out.  Patient also experienced rapid heart beat. There was no redness or swelling in the area the vaccine was administered. There was some decrease in mobility of L arm, fingers and hand. Pt. suffered extreme pain and soreness in the area around the injection for 6 days. Pt indicated she would take Aleve & come to the CHD for evaluation, but did not come in.									U	10/28/2008	10/28/2008	0	N/A	PUB	PUB	NASONEX	N/A	TWISTED THE LUMBAR 4 IN BACK APPROX 1 WEEK PRIOR TO VACCINE.  PT IS BEING TREATED BY A CHIROPRACTOR & MASSAGE THERAPIST.			1						1	Dizziness; Erythema; Heart rate increased; Hypoaesthesia; Injected limb mobility decreased; Injection site pain; Pain in extremity; Presyncope	FLU3~SANOFI PASTEUR~U2805AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331708	11/07/2008	MI	29.0	29		F	11/07/2008	PATIENT DEVELOPED A RED RASH ON ARMS AND ABDOMEN WITHIN AN HOUR AFTER ADMINISTRATION OF INFLUENZA VACCINE. THE PROVIDER ADMINISTERED AN ORAL BENEDRYL. THE PATIENT WAS MONITORED FOR AT LEAST ANOTHER HOUR BEFORE SHE WAS RELEASED.									Y	11/07/2008	11/07/2008	0		PUB	UNK						1						1	Rash; Rash erythematous	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8811001~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331709	11/07/2008	AZ	34.0	34		F	11/07/2008	5pm started felling nauseated, 7pm started feeling flush, fever of 100.9, arm started aching, hive appeared a size of a quarter, and felt dizzy. 8:30pm asthma problems(took normal asthma medication) and all symptoms got worse fever 102.4. 8am hive and arm pain worse, pain and redness at injection site, called doctor. Nurse called back at 3pm was told to take benadryrl and to go to the hospital if things get worse. 5pm took benadryl did not help. 10pm took benadryl did not help. Four days later and the hive and injection site redness is starting to get a little lighter no more fever. Arm is still extremely sore.									U	11/03/2008	11/03/2008	0		PVT	PVT	albuteral,estradiol,potassium,ranitidine,topamax,toprol xl,and zyrtec.		RSD,migraine headaches,asthma, high blood pressure,gluacoma,and arthritis.	flush,fever,dizzy,hive,redness,pain,and nausea~Influenza (Seasonal) (no brand name)~UN~34.30~In Patient		1						1	Asthma; Dizziness; Flushing; Injection site erythema; Injection site pain; Nausea; Pain; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~2~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331711	11/07/2008	GU	53.0	53		F	11/07/2008	Flu shot was given on the 7th of Nov, 2008, at approx. 12:noon; @ approx. time between 6:30 to 7:30 p.m, side effects began with muscle aches, fatigue, chills, nausea (but no vomiting occured), weakness, exact symptom as if with extreme high fever. However, temperture is normal. At this point, I took two tylenol (extra strength)for my aches & pain. As time passes within an hour or so, hives occured all on the left side of facial & neck, beginning with left side of tongue. Another hour passes, and right side of tongue had tingling feeling, as if swelling is about to begin. I ate warm broth with noodles for dinner, and with my personal remedy that it could help reduce the swelling. Another hour passed after dinner, and the swelling reduced on the left side of tongue, facial & neck, and tingling feeling on the right side of tongue has stopped. Woke up this morning (following day), with occuring muscle aches and headache. Reluctant to take another dose of tylenol on a empty stomach, I drank two cups of hot coffee instead (my usual routine in the morning). Headache seem to go away, but occuring muscle aches were still present. As I type this description, my muscle aches seem to be reducing. At this point, I think I'll be fine now, otherwise, I'll be back to report more side-effects.									U	11/07/2008	11/07/2008	0	None	UNK	UNK	none	none	allergy to dilantin (1996). no medication followed. last episode of seizure since mid-year of 1999.	none~ ()~UN~~In Patient|none~ ()~UN~~In Sibling1|none~ ()~UN~~In Sibling2		1						1	Asthenia; Chills; Fatigue; Headache; Myalgia; Nausea; Paraesthesia oral; Urticaria	FLUX~UNKNOWN MANUFACTURER~unknown~2~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331712	11/07/2008	CO	76.0			F	11/07/2008	Approx. 2min after vaccine was administered to the left deltoid, swelling/redness developed  (4cm diameter) at injection site. Patient was imediately given 50mg of diphenhydramine, the swelling/redness decreased in size, to 3cm, within 30 min. Patient sent home w/ 50mg diphenhydramine q6h x2d w/ 600mg ibuprofen q6h prn pain. Followed-up 3 days later, patient stated arm was still tender, slightly swollen and a bruised color; patient did not take any OTC pain medication or seek any other medical attention. Followed-up 5 days later, patient stated arm was still tender and turning a yellow color, pain was tolerable and she did not need to take any over the counter pain medication.									Y				Swelling and redness visually decreased in size.	PUB	UNK	metformin, metoprolol, and levothyroxine	None	None	none~ ()~NULL~~In Patient		1						1	Injection site erythema; Injection site haematoma; Injection site pain; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua375aa~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331713	11/07/2008	NE	42.0	42		F	11/07/2008	Received vaccine in right deltoid--3 to 5 minutes later developed hot sensation in rt shoulder radiating into middle of rt chest. Pain developed across chest and persisted to some extent until evening, then moved more into rt axillary area. Was sore with every position change. Developed palm size swelling in rt axilla that remains soft. No rash, no breathing difficulties, no fever. Rx consisted of ibuprofen for soreness.									Y	11/05/2008	11/05/2008	0		PUB	PUB	no known	none	none			1						1	Axillary mass; Axillary pain; Chest pain; Feeling hot	FLU3~SANOFI PASTEUR~U2797AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331714	11/07/2008	CA	9.0	9		M	11/07/2008	NONE									U	10/24/2008	10/24/2008	0	GAVE AN EXTRA VARIVAX	PUB	PUB	UNKNOWN	NONE	NONE			1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U2748AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB257AA~1~IM~LA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~0135X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0331716	11/07/2008	WA	20.0	20		M	11/07/2008	vaccine 7/6/08night time sore throat, fatigue, malaise, fever. today fever 101. achey. throat red. rapid strept negative. cbc, cmp, blood and throat culture taken. ceftin prescribed as may have bacterial throat infection.									U	07/06/2008	07/06/2008	0		UNK	PVT		none	none			1						1	Blood culture; Culture throat; Fatigue; Full blood count; Laboratory test; Malaise; Pain; Pharyngeal erythema; Pyrexia; Streptococcal identification test negative	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331719	11/07/2008	VA	50.0	50		F	11/07/2008	PATIENT DESCRIBED EXPERIENCING A LUMP IN THROAT AND DIFFICULTY SWALLOWING, WHEEZING, AND RED EYES,SEVERAL HOURS (ABOUT 6 HOURS) AFTER RECEIVING VACCINE. ALSO SAID SHE HAS A LOT OF FOOD ALLERGIES BUT DOES EAT EGGS WITHOUT REACTING. SHE TOOK 2 DOSES OF 2 BENADRYL 25MG AND THAT WORKED TO RELIEVE THE SYMPTOMS									Y	10/24/2008	10/24/2008	0		UNK	PVT	NOT KNOWN		FOOD ALLERGIES BUT NOT TO EGGS   SEASONAL ALLERGIES			1						1	Dysphagia; Ocular hyperaemia; Sensation of foreign body; Wheezing	FLU3~SANOFI PASTEUR~U2741AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331720	11/07/2008	NY	32.0	32		F	11/07/2008	I got a flu shot at 5pm on 11/6/08. Almost immediately, I had severe pain in the arm the shot was given in. It followed with pain in my legs and numbness in both of my hands. Then I broke out in hives from head to toe. My throat began to feel like it was closing up. This lasted for several hours. The next day, I was extremely tired and ached all over. I still had some pain in my back and legs. It was like I had the flu. I took nothing and hoped that it would go away. I called my doctor's office the next morning (11/7/08) and spoke to a nurse, who told me that if needed to take a Benadryl and go to the ER if needed. She said she would put it in my chart, but was unconcerned with the event.									Y	11/06/2008	11/06/2008	0		UNK	UNK	Trivora - Birth control pills	None	None			1						1	Fatigue; Hypoaesthesia; Immediate post-injection reaction; Influenza; Pain; Pain in extremity; Throat tightness; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~Unknown~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331721	11/07/2008	KS	41.0	41		F	11/07/2008	10/22 received flumist  10/23-pt had all over body aches t-102, chills, temp returned to normal with tylenol and motrin. 10/27-finally felt well enough to go to work.  shaky with walking, heavy head, hands, feet, tired.  11/4-chest pain radiating up to neck and left arm. nausea diarrhea x5 decreased heart rate and b/p.  admitted to hospital.  2/17/09 Received hospital medical records of 11/4-11/6/2008. FINAL DX: suspect viral syndrome possibly secondary to nasal flu vaccine; rhabdomyolysis possibly secondary to above; left bundle branch block; mild congestive cardiomyopathy w/LV dysfunction; bradycardia; diarrhea. Records reveal patient experienced chest pressure, nausea, lightheadedness, general discomfort.  Cardio & Neuro consult done.  Improved w/IVF & d/c to home w/serial labs.					Y	2			Y	10/22/2008	10/23/2008	1	11/5- heart cath with ef of 45-50%. ana-neg, rheumatoid factor <5, cbc-nonsign, bmp-nl,11/4-ck-4280,ldh- 278, ast-95, crp-.52, dig level-0.5, tsh-2.05, t3-1.11,urine-neg,cta chest-mild atelectesis negative for pe, gb sono-nl, echo-nonsignif, ck on dismissal-1161  Pt is a weight lifter and body builder who cont. normal lifting throughout illness. Pt also went on 125 mile bike ride on weekend before chest pain.  The neurologist who was consulted on this pt documented that pt had suspect viral syndrome after nasal flu vaccine, rhabdomyolosis secondary to previous diagnosis, lbbb, mild cardiomyopathy.   This is why I am reporting.  LABS: cardiac cath w/LV function 45%; congestive cardiomyopathy & normal coronary arteries w/anterior wall hypokinesis.  CPK4280(H), MB & Troponin neg.  EKG & echocardiogram abnormal.	UNK	UNK	digoxin, vitamins, ramipril, calcium, fish oil	denied	morphine, keflex, lortab, hx of gyn problems, heart problems,			1						1	Antinuclear antibody negative; Aspartate aminotransferase increased; Blood creatine phosphokinase increased; Blood lactate dehydrogenase increased; Blood pressure decreased; Blood thyroid stimulating hormone normal; Bundle branch block left; C-reactive protein normal; Cardioactive drug level decreased; Catheterisation cardiac abnormal; Chest pain; Chills; Computerised tomogram abnormal; Diarrhoea; Fatigue; Full blood count normal; Gait disturbance; Head discomfort; Heart rate decreased; Metabolic function test normal; Nausea; Neck pain; Pain; Pain in extremity; Rheumatoid factor negative; Sensation of heaviness; Tri-iodothyronine decreased; Ultrasound scan normal; Urine analysis normal	FLUN3~MEDIMMUNE VACCINES, INC.~500550T~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0331722	11/07/2008	NV	44.0	44		M	11/07/2008	Started about 4-6 hours after vaccination:  Dizziness (30 min), shortness of breath (1 hour), sweating (2-4 hours), fatigue (24 hours), weak feeling (24 hours), high fever (lasted all night, 4-6 hours), head ache (2-4 hours) and body aches (2-4 hours).  Treatment: tylenol to break fever and head/body ache and bed rest (24 hours).									Y	10/25/2008	10/25/2008	0	none	PUB	PUB	none	none	none			1						1	Asthenia; Bed rest; Dizziness; Dyspnoea; Fatigue; Headache; Hyperhidrosis; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~0~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331745	11/07/2008	WA	89.0	89		F	11/07/2008	This case was reported by a healthcare professional and described the occurrence of wrong route of administration in a 89-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included arthritis, depression, drug allergy, gastritis, hypertension and polymyalgia rheumatica. Concurrent medications included Unknown (Concurrent medications). At the time of event, the subject was already hospitalized for altered mental status, abdominal pain and unsteady gait. On 3 November 2008 at 01:00 the subject received a dose of FLUARIX at 0.5 ml, intravenously, through a peripheral intravenous line in the left wrist. This was the wrong route of administration. FLUARIX should be administered intramuscularly. It was reported that the subject was hospitalised due to the event or that the event prolonged hospitalization. The pharmacist did, however, comment that the event unlikely extended the admission.					Y	0			U	11/03/2008	11/03/2008	0	UNK	PVT	PVT	Unknown	Arthritis, Depression, Drug Allergy, Gastritis, Hypertension, Polymyalgia Rheumatica	The subject has drug allergies to Lovastatin, Nicardipine and sulfa drugs. At the time of event was already hospitalized for altered mental status, abdominal pain and unsteady gait. There was no documented history of reactions following previous flu shots and no documented history of adverse reactions following previous vaccinations.		A0755287A	1						1	Incorrect route of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA366CA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0331746	11/07/2008	NY	65.0			F	11/07/2008	This case was reported by the daughter of a consumer and described the occurrence of multiple venous clots in a 65-year-old female subject who was vaccinated with Flu vaccine (GlaxoSmithKline), Pneumonia vaccine. A physician or other health care professional has not verified this report. On an unspecified date the subject received 1st dose of Flu vaccine (unknown GSK vaccine) and unspecified dose of Pneumonia vaccine (unknown). On the same date of vaccination with Flu vaccine and Pneumonia vaccine, the subject developed muscle pain. She became very ill and was hospitalized. It was discovered through muscle biopsy that the subjects veins were throwing clots everywhere. At the time of reporting, the subject was still hospitalised and myocitis was ruled out. Physicians were still not able to determine the cause of the subjects clotting disorder. At the time of reporting the events were unresolved.					Y	0			N				A muscle biopsy performed on an unspecified date revealed that the subjects veins were throwing clots.	OTH	OTH		Unknown	The subject has not previously received flu shots.		A0755315A	1						1	Biopsy muscle abnormal; Coagulopathy; Embolism; Malaise; Myalgia; Venous thrombosis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0331747	11/07/2008	CO				F	11/07/2008	This case was reported by a pharmacist and described the occurrence of hypertension in an adult female subject who was vaccinated with FLUARIX (GlaxoSmithKline). There were no concurrent medications. On 31 October 2008 the subject received a dose of FLUARIX at 0.5 ml. On 31 October 2008, less than one day after vaccination with FLUARIX, the subject experienced hypertension, trouble breathing and tachycardia. She was seen in the emergency room and was treated and released. The pharmacist considered the events were clinically significant (or requiring intervention). On 1 November 2008, the events were resolved. The pharmacist considered the events were possibly related to vaccination with FLUARIX.				Y					Y	10/31/2008	10/31/2008	0	Unk	PUB	PUB	No concurrent medication	Unknown	The subject had no relevant medical history. The subject has previously received flu shots with no reported adverse reactions. Just last year she received the flu vaccine without problems. There was no reported history of adverse events following previous vaccinations. The subject reported no allergy to eggs or thimerosal.		A0755441A	1						1	Dyspnoea; Hypertension; Tachycardia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA356BA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0331759	11/07/2008	IL	58.0	57		F	11/07/2008	Pt states L arm red, swollen hot, et there is a 4 band at bottom of site halfway around front of arm to back - suggested she contact her personal physician.									U	11/05/2008	11/07/2008	2		PUB	PVT						1						1	Erythema; Feeling hot; Oedema peripheral	FLU3~SANOFI PASTEUR~U2744AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0554U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331764	11/07/2008	VA	12.0			F	11/07/2008	8cm x 11cm hot indurated area where site of vaccine administered. c/o h/a myalgia. Seen by RN.				Y						11/04/2008	11/05/2008	1		OTH	PUB		NONE				1						1	Headache; Injection site induration; Myalgia	FLU3~SANOFI PASTEUR~U2831AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2657AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~1013X~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0331767	11/07/2008	GA	66.0	66		F	11/07/2008	The evening after PNEUMOVAX vaccination her shot area down to swelled up. More notable the next morning Thursday. Called her Friday afternoon to check how she was doing.									Y	11/05/2008	11/06/2008	1		OTH	OTH		NONE				1						1	Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0248X~1~SC~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331771	11/07/2008	VA	65.0	65		F	11/15/2008	Cellulitis- type reaction. WBC = 8.1									Y	11/04/2008	11/05/2008	1		PUB	OTH		Hip pinning	NKA			1						1	Cellulitis; White blood cell count normal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8788204~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0978X~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331775	11/07/2008	FL	82.0	82		F	11/08/2008	At 4:15pm 11/7/08 pt received FLUVIRIN vaccine. About 5 minutes after pt noted feeling peculiar. No visible observable signs of anaphylaxis. 911 was dialed pt was fully responsible at all times. EMS service noted blood pressure at 195/101. Transported pt to ER.				Y					Y	11/07/2008	11/07/2008	0	EMS Blood pressure reading: 195/101	OTH	OTH						1						1	Feeling abnormal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89994~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0331777	11/07/2008	AL	19.0	19		F	10/28/2008	Redness around injections site with swelling									Y	10/28/2008	10/28/2008	0		UNK	UNK						1						1	Injection site erythema; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89984~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0551X~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331781	11/07/2008	WI	55.0	55		F	11/07/2008	Lt arm red warm to touch. Fever noted. Slightly swollen, radiating down arm.				Y					Y	11/04/2008	11/04/2008	0	Physical clinical observation	PVT	UNK		NONE	Hypertension, Hyperlipidemia			1						1	Erythema; Oedema peripheral; Pyrexia; Skin warm	FLU3~SANOFI PASTEUR~U2755AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0813X~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331782	11/07/2008	IL	16.0	16		M	11/07/2008	Pt fainted after receiving vaccination. Hypotension 90/60 supine 104/90 sitting HR 50. Passed out a 2nd time. BP: 93/37 HR 50. No SOB, stridor, or difficulty breathing.				Y					Y	11/07/2008	11/07/2008	0	Pt taken to ER by paramedics. Blood glucose 85	OTH	OTH	NONE	NONE	NONE KNOWN			1						1	Blood glucose normal; Hypotension; Immediate post-injection reaction; Loss of consciousness; Syncope	FLU3~SANOFI PASTEUR~U2806AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331783	11/07/2008	WA				F	11/06/2008	Fine papalar rash covering entire trunk and arms, itchy										10/22/2008	10/23/2008	1	NONE	PUB	UNK	NONE	NONE	NONE			1						1	Rash papular; Rash pruritic	FLU3~SANOFI PASTEUR~U2808AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331724	11/08/2008	NM	23.0			M	11/08/2008	Patient received vaccine at College of Pharmacy/College of Nursing Flu shot clinic event. The event was under the protocol of the Hospital flu vaccination project. Vaccine administered by pharmacy student on 10/24/08 - about 1 PM. About a week later, the patient talked to me about the symptoms. These are his exact words:  I had a slight ache around the injection site for a few days but the symptoms really started to bother me about 5-6 days after the shot. it seems to have gotten a little better but over the last two days I haven't had any improvement. I just have a constant dull ache in my shoulder basically all the time. I feel like it might be nerve related but I also have muscle soreness so I don't know. This was received by me 11-7-08, after I asked for permission to release his name and condition. This was actually the second case that had been described to me - so I thought it was time for a VAERS - the side effects somewhat different than  the usual sore arm. I suggested patient see his doctor or student health.				Y					Y	10/24/2008	10/30/2008	6		UNK	UNK		none				1						1	Injection site pain; Musculoskeletal pain; Myalgia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89880~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0331726	11/08/2008	OK	42.0	42		F	11/08/2008	Pt had chills, very high fever (104.5 or higher) and vomiting.  Pt was delirious for 11 hours.  No treatment as pt was too sick to get anywhere and was not thinking clearly.									Y	11/04/2008	11/04/2008	0		MIL	UNK	Zocor 80 Mg, Abilify 30 mg, Oxycodone 10 mg CR, Oxycodone 5 mg IR, Trazadone 50 mg, Vit D with Calcium, Diclofenac 75 mg, Asmanex	No	Sulfa, Penycillin, Amoxycillin, Seafood, ASA: Asthma, Spinal Injury, Knee Injury, Fibromyalgia, Polymyalgia Rheumatica, Arthritis, Disintegrating Disc Disease,			1						1	Chills; Delirium; Pyrexia; Thinking abnormal; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA174AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331727	11/08/2008	CA	52.0	0	.0	F	11/08/2008	I developed a left Frozen Shoulder in August 2008. This development was not temporily linked to an injury event. The pathophysiology of Frozen Shoulder is related to wound healing.  The only physical trauma I've experience to the local anatomical site is annual flu vaccines. Is it possible that vaccination is triggering the induction of uncontrolled fibrogenesis that is characteristic of the Frozen Shoulder and Dupuytren's contracture pathophysiology? Perhaps there exists a susceptible subpopulation? Frozen Shoulder is 8 times more likely to occur in individuals that have Dupuytren's Contracture. I was diagnosed with bilateral Dupuytren's in 2006.									N	10/15/2007	08/01/2008	291	An MRI was performed on the left shoulder	MIL	MIL	None	None	Tetracycline allergy, bilateral Dupuytrene's contracture	frozen shoulder~Influenza (Seasonal) (no brand name)~UN~56.00~In Sibling1		1						1	Nuclear magnetic resonance imaging; Periarthritis	FLUX~UNKNOWN MANUFACTURER~~UNK~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331728	11/08/2008	AZ	60.0	60		F	11/08/2008	1212 - APPROXIMATELY 3 MINUTES AFTER RECEIVING VACCINATION, PATIENT BECAME FLUSHED AND C/O NUMBNESS & SWELLING OF MOUTH & TONGE.  STATES SAME REACTION SHE GETS FROM BEE STINGS.  SKIN COLL, MOIST, & FLUSHED.  FACE EXTREMELY FLUSHED WITH BEGINNING OF ANGIOEDEMA. 1215 EPIPEN ADMINISTERED INTO LEFT OUTER THIGH.  1217 - 911 CALLED.  1219 - VITAL SIGNS: BP 142/80, HR 94 RRR, RR 16, LUNGS CTA, DENIES SOB, DYSPNEA.  1221 - EMERGENCY PERSONNEL ARRIVED & PROVIDED EMERGENCY TREATMENT.  PT TRANSPORTED TO HOSPITAL VIA AMBULANCE.  11/25/08 Reviewed ER medical records of 11/8/2008. FINAL DX: acute allergic reaction Records reveal patient experienced SOB, redness & oropharyngeal swelling within 2 min of flu shot.  Tx w/epi & benadryl prior to arrival in ER.  Tx w/oral steroid & antacid.  Complete resolution of symptoms & d/c to home on continued steroid & antihistamine.			Y	Y					U	11/08/2008	11/08/2008	0	NA	UNK	UNK	NONE	NONE	NONE			1						1	Angioedema; Cold sweat; Flushing; Hypoaesthesia oral; Immediate post-injection reaction; Swollen tongue	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening	Influenza
0331729	11/08/2008	WI	47.0	47		F	11/08/2008	difficulty breathing, horseness, sore , dry throat, hives, weakness									Y	11/06/2008	11/07/2008	1		PVT	UNK	triamitrene	no				1						1	Asthenia; Dry throat; Dysphonia; Dyspnoea; Oropharyngeal pain; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331730	11/08/2008	CA	67.0	67		M	11/08/2008	My wife (a RN) and I had flu shots two days apart and at different facilities.  Since a week ago we have both had violent vomiting, high fever, continuous diarrhea and bouts of extreme shivers.  The condition continues for both of us.  Great vaccine!  Neither of us will ever get another flu shot.  Neither of us were sick prior to the vaccine injection.  We have both had flu shots for many years prior with no adverse reactions.									N	11/05/2008	11/05/2008	0		MIL	UNK	None	None	None	None~ ()~NULL~~In Patient		1						1	Chills; Diarrhoea; No reaction on previous exposure to drug; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331731	11/09/2008	NH	51.0	51		F	11/08/2008	15 minutes after receiving flu vaccine I began to have signs of advancing anaphylactic shock. Breathing became difficult, my larynx spasmed and I was unable to speak, profuse sweating, weakness in limbs, dizzines,inability to walk. Transported by ambulance to Hospital, at 6:00pm. Albuterol inhaler used and 0.3mg Epinephrine autoinject pen. Enroute to the hospital an IV line was started and I received a nebulizer treatment, 50 mg Benadryl orally, and more Epinephrine and then was on oxygen for a total of four hours. Dr. at hospital administered more Benadryl, Prednisone Solumedrol. Laryngeal spasms lessened by 8:30 pm. I was discharged about 9:00 pm with a prescription for 40 mg Prednisone for four days and instruction to take 50 mg of Benadryl once at home.				Y					Y	11/04/2008	11/04/2008	0	Pulse Ox, Blood Pressure, EKG at Hospital	UNK	UNK	Zyrtec 10mg 1 x day, Hydrochlorothiazide 25mg 1 x day, Ursodiol 300mg 1 x day.	None	Allergy to Latex, history of pancreatitis and biliary tract disease	Anaphylaxis~Influenza (Seasonal) (no brand name)~1~50.70~In Patient		1						1	Abasia; Dizziness; Dyspnoea; Electrocardiogram; Hyperhidrosis; Laryngospasm; Muscular weakness; Oxygen saturation	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0331733	11/09/2008	AZ	62.0	62		F	11/09/2008	Pt. stated received flu vaccine Wed, however, our records indicated she received the flu vaccine Thur, Nov 6 1830: Fri - per pt., arm was sore and felt fine; Sat: started N/V, vomited 2 times on Sat., diarrhea at least 8 times, fever 101.7; Sun: took benadryl x 2 at 3 am and 2 more at 8 am for itching. Diarrhea at 0600 x 1. Current fever 97.9 (1200 11/9/08), and reported was doing better and did not want to go to ED.									N	11/06/2008	11/08/2008	2		PUB	PVT	lomotil, ritalin, valium 10 mg at HS, zoloft 100 mg BID, prn salligan, vicodin - 1-2 /day prn	Has been on antibiotics for abscess in tooth x 2 weeks and has 2 more weeks to go. clindamycin 150 mg 2 tabs BID - reported has missed some doses	NKDA: fibromyalgia, irritable bowel (?), sogrens syndrome, GERD, osteoarthritis	No prior~ ()~NULL~~In Patient|No~ ()~NULL~~In Sibling1|No~ ()~NULL~~In Sibling2		1						1	Diarrhoea; Nausea; Pain in extremity; Pruritus; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2949AC~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331734	11/09/2008	TX	6.0	6		F	11/09/2008	Patient began to have hives 3 hours after receiving varivax and influenza vaccine.  she began self treatment with bendaryl with good response.  No breathing difficulties or vomiting.				Y					Y	11/04/2008	11/04/2008	0		PVT	PVT	amoxil	Perianal streptoccal infection dx by me on 10/29/2008	constipation, allergic rhinitis			1						1	Urticaria	FLU3~SANOFI PASTEUR~u2739AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1009X~2~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0331736	11/09/2008	CO	76.0	76		F	11/09/2008	Approximately 2 minutes after the vaccine was administered to the patient's left deltoid, a 4cm diameter red swelling with pain appeared at the injection site.  The patient was immediately given 50mg of diphenhydramine.  Within 30 minutes, the swelling was reduced to 3cm.  Patient was sent home with 50mg of diphenhydramine given every 6 hours for 2 days, and was also given 600mg of ibuprofen to take every 6 hours as needed for pain.  With the clinic closing for the weekend, we explained when to seek medical attention if needed over the weekend.  We followed up with the patient 3 days later (on Monday), and the patient said the injection site was still tender with a bruised coloration.  She had not taken the OTC pain medication and did not seek further medical attention.  Five days later, we followed up again, and the patient said the pain was tolerable, the coloration was now yellow, and that she did not require any pain medication.									Y	10/24/2008	10/24/2008	0		PUB	PVT	Metformin, metoprolol, and levothyroxine	None	None	None~ ()~NULL~~In Patient		1						1	Injection site erythema; Injection site haematoma; Injection site pain; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA375AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331737	11/09/2008	WA	64.0	64		F	11/09/2008	Pt expressed that she began having symptoms including fever (unknown actual temp.), chills, dizziness, and joint and muscle aches that peaked four days after vaccination.  On Sunday Nov. 2nd she saw large red spots on her right arm and decided to be seen at urgent care.  Dr. prescribed a course of antiobiotics...pt thought to be cephalexin.				Y					U	10/29/2008	11/01/2008	3	unknown	UNK	PVT						1						1	Arthralgia; Chills; Dizziness; Myalgia; Pyrexia; Rash erythematous	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~87887-3p~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0380u~5~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331739	11/10/2008		21.0	21		M	11/10/2008	Abdominal and joint pain, swelling of hands x 1wk. Lesions noted on bilateral lower extremities. Tx'd with Prednisone 60mg x 3 days.				Y					Y	10/21/2008	10/26/2008	5	ESR-wnl UA-wnl CBC-wnl	MIL	UNK	None	None	None	rash~Influenza (Seasonal) (FluLaval)~1~21.00~In Patient		1						1	Abdominal pain; Arthralgia; Full blood count normal; Oedema peripheral; Red blood cell sedimentation rate normal; Skin lesion; Urine analysis normal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflla177aa~1~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0331766	11/10/2008	NH	57.0	57		F	11/05/2008	Approx. 4 1/2 hours after vaccine noted Something wrong in throat. 7 hrs after vaccine lips tripled, tongue felt as if recovering from Novocain. Following morning, lips still a little tirply and felt loopy. Went to ER -Rx with Nebulizer IM  steroid				Y					U	10/28/2008	10/28/2008	0	EKG; BW - results unknown	OTH	PVT	Unknown	Unknown, but denied fever	Allergy to sulfa + hx multiple other allergies (unknown which ones)			1						1	Electrocardiogram; Feeling abnormal; Hypoaesthesia oral; Laboratory test; Lip swelling; Throat irritation	FLU3~SANOFI PASTEUR~02751AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331769	11/10/2008	KY	4.0	4		F	11/06/2008	Pt received 5th dose DTaP (TRIPEDIA from Sanofi) on (R) thigh on 10/29/08. Woke up on 10/31 (<48 hrs) with red, itchy, hot enlarging rash at the vaccine site, had 5x inches indurated, hyperemia all around the vaccination site. RTC BENADRYL, KEFLEX given cold/warm compress.				Y					U	10/29/2008	10/31/2008	2	None	PVT	PUB						1						1	Hyperaemia; Injection site erythema; Injection site induration; Injection site pruritus; Injection site rash; Injection site warmth	DTAP~SANOFI PASTEUR~U2356CA~5~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2811AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A1060~5~SC~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~08914~2~IM~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0331772	11/10/2008	IL	77.0	77		F	11/09/2008	Severe soreness in left shoulder (injection site) resulting in inability to use arm (per patient).  Suggested treatment over the counter with Ibuprofen, and a doctor visit, if no relief.									U	10/06/2008	10/07/2008	1	None	OTH	PVT	Atenolol, Dyazide	None	Hypertension			1						1	Injected limb mobility decreased; Injection site pain; Injected limb mobility decreased; Injection site pain; Musculoskeletal discomfort	FLU3~SANOFI PASTEUR~U2785HA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2785HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0331772	11/10/2008	IL	68.0	77		F	11/08/2008	Severe soreness in left shoulder (injection site) resulting in inability to use arm (per patient). Suggested treatment over the counter with ibuprofen, and a doctor visit, if no relief.									U	10/06/2008	10/07/2008	1	None	UNK	PVT	Atenolol, Dyazide	None	Hypertension			1						2	Injected limb mobility decreased; Injection site pain; Injected limb mobility decreased; Injection site pain; Musculoskeletal discomfort	FLU3~SANOFI PASTEUR~U2785HA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2785HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0331776	11/10/2008	FL	65.0	65		F	11/07/2008	Client received Influenza Virus vaccine at 12:00 pm 10/31/2008.  Client returned to clinic-12:20pm 10/31/08 with c/o throat tightness and enlarged tongue upon exam, noted enlarged tongue.  Pharynx open. Lungs CTA bilaterally no wheezing. Epipen 1:1000 .3mg given in L anterolateral thigh at 12:23 p.m....  Paramedics arrived at 12:25 p.m client reported felt better after Epipen. Client sent to ER via ambulance for further evaluation at 12:30 pm 10/31/2008.				Y					Y	10/31/2008	10/31/2008	0	None	PUB	PVT	B/P Medication (name unknown)	None	HTN			1						1	Swollen tongue; Throat tightness	FLU3~SANOFI PASTEUR~U2771AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331779	11/10/2008	AZ	55.0	55		F		Hives, swollen glands, redness in lymph areas.									U	11/04/2008	11/04/2008	0		UNK	PVT	CLARITIN, PROZAC	None	Intolerance to milk.			1						1	Erythema; Lymphadenopathy; Urticaria	FLU3~SANOFI PASTEUR~U2809AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0990U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331780	11/10/2008	NY	9.0	9		M	10/31/2008	Hives occurring the next morning. Tx: Benadryl Q6hr prn. Was seen 11/3/08 hives were resolved by next day.									Y	10/30/2008	10/31/2008	1	None	PVT	UNK	Claritin; Albuterol	Asthma Exacerbation				1						1	Urticaria	FLU3~SANOFI PASTEUR~U2790BA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331789	11/10/2008	UT	46.0	46		F	11/06/2008	Initial report received from a health professional on 27 October 2008. A 46-year-old female patient had received a dose of FLUZONE SV 2008-2009 (lot number unknown; route and site of administration not reported) on 20 October 2008 and within 24 hours, she complained of sudden hearing loss in her right ear. The patient was seen by a physician on 22 October 2008. No additional details were provided. Documents held by sender: None				Y					U	10/20/2008	10/21/2008	1	Not reported.	UNK	UNK			History of Eustachian tube problems (not specified).		200803358	1						1	Deafness unilateral; Sudden hearing loss	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331790	11/10/2008	NV	66.0	66		M	11/06/2008	Initial information was received on 28 October 2008 from a consumer. A 66 year old male patient with a history of enlarged prostate, acid reflux, allergies to CIPRO and NEOSPORIN antibiotic cream received an intramuscular left deltoid injection of FLUZONE (lot number U2742AA) on 26 October 2008 at 1:25 PM. The patient reported that he received FLUZONE on a yearly basis since 1999. He had similar symptoms in the past although the symptoms were not as severe. On 26 October 2008 at 5:30 PM the patient developed difficulty breathing, wheezing, coughing, couldn't talk and upper chest discomfort. At 6:30 PM the patient's eyes became gritty, white pus coming out of the eyes, eyes were blood shot and vision was blurred. At 7:30 PM his pulse was elevated. At 8:15 the patient was still wheezing but improved after he took BENADRYL. On 27 October 2008 his eyes were hurting and on 28 October 2008 his eyes were red. It was noted that the patient was seen by the paramedics but refused to go to the hospital. The patient was not recovered at the time of the report. List of Documents held by Sender: None.				Y					N	10/26/2008	10/26/2008	0	Not reported.	OTH	OTH	PRILOSEC; UROXATRAL; glucosamine; vitamin B; AVODART		Patient's past medical history included enlarged prostate, acid reflux, CIPRO allergies and NEOSPORIN antibiotic cream allergy.		200803361	1						1	Chest discomfort; Cough; Dyspnoea; Eye discharge; Eye pain; Heart rate increased; Ocular hyperaemia; Speech disorder; Vaccine positive rechallenge; Vision blurred; Wheezing	FLU3~SANOFI PASTEUR~U2742A~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331791	11/10/2008	VA	79.0			F	11/06/2008	Initial report received from another manufacturer on 29 October 2008 who received the report from a health care professional. A female patient (age not reported) developed reactive pericarditis after receiving an unspecified influenza vaccine. The date of the vaccine administration and the date of onset of symptoms were not specified. No additional details were reported. Documents held by sender: None  11/21/08 Reviewed Pulmo records received from CDC. FINAL DX: COPD Records reveal patient had been hospitalized 12/2002 w/pleural effusion secondary to flu shot & was seen in office 8/9/2003.  Had thoracentesis in hospital that was non-diagnostic.  Cardiac w/u neg.  Had continued SOB.  Ex-smoker who quit 12/2002.  CXR c/w COPD.  Tx w/inhalers.				Y					U				Not reported.	UNK	UNK			Not reported.		200803365	1						1	Pericarditis	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0331792	11/10/2008	GA				U	11/06/2008	Initial information was received on 29 October 2008 from a manufacturer whose initial reporter was a health care professional. A patient experienced an anaphylactic reaction after receiving a flu vaccine (manufacturer unknown). The lot number, route, site and date of vaccination was not reported. No further information was available. List of Documents held by Sender: None.				Y					U				None reported.	UNK	UNK					200803366	1						1	Anaphylactic reaction	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331793	11/10/2008	CT	41.0	41		F	11/06/2008	Seriousness Criteria: Other-Medically Significant. Initial report received from a health care professional on 29 October 2008. A 41-year-old female patient had received a left deltoid intramuscular injection of FLUZONE SV 2008-2009 (lot number U2752AA) and on her way back to work, she blacked out for a few seconds. This caused the patient to have a minor car accident, in which she was not injured. The patient recovered and denied any further symptoms. No additional details were provided. Documents held by sender: None				Y					Y	10/27/2008	10/27/2008	0	None	OTH	OTH			Past medical history and concomitant medications were unknown. The patient had no illnesses at the time of vaccination.  She had not received any other vaccinations within four weeks of receiving FLUZONE.		200803371	1						1	Loss of consciousness; Road traffic accident	FLU3~SANOFI PASTEUR~U2752A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331794	11/10/2008	TX				F	11/06/2008	Seriousness Criteria: Other-Medically Significant. Initial information was received on 30 October 2008 from a health care professional. A female patient received an injection of FLUZONE (lot number, route, site and number of previous doses were not reported) on 28 October 2008. Four hours post vaccination the patient reported swollen lips, tight chest, shortness of breath, and congestion. The patient took two BENADRYL, symptoms decreased and the patient was back to work the following day. However, the patient's recovery status was not reported. List of Documents held by Sender: None.				Y					N	10/28/2008	10/28/2008	0	None reported.	UNK	UNK			Not reported.		200803390	1						1	Chest discomfort; Dyspnoea; Lip swelling; Respiratory tract congestion	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331795	11/10/2008	NJ	4.0	4		F	11/06/2008	Initial information was received on 31 October 2008 from the consumer's parent. A four year old female patient with a latex allergy received FLUZONE intramuscularly in the left deltoid (lot number not reported) on 29 October 2008 at 6:00 pm. On 30 October 2008 at 2:00 am the patient developed a low grade temperature, body was covered in hives which were red, raised, and itchy, The patient's parent gave the BENADRYL. The patient's hands began to swell later that day. The patient was seen by her doctor who prescribed prednisolone and continued with BENADRYL. The patient was scheduled to visit with her allergist. The patient was not recovered at the time of the report. List of Documents held by Sender: None.				Y					N	10/29/2008	10/30/2008	1	None.	PVT	PVT			The patient had a latex allergy.		200803391	1						1	Body temperature increased; Erythema; Oedema peripheral; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331814	11/10/2008	MN	64.0	64		F	11/03/2008	Red blotches on (L) arm, severe S.O.B., heart palpitations, increased pulse (up to 165), face flushing, could not eat, weight loss. Hospital in PT 2 times, Endoscopy, Colonoscopy, CT Scans, Echocardiogram, Blurred vision, severe diarrhea, etc, etc. 11/17/08-records received 11/17/08 presented to clinic on 11/29/08- for evaluation of C/O blotchiness distal to injection site for 3 days with soreness. On 11/21/08 felt tired and some lethargy. 1 day of congestion. Bit out of breath on 11/23 and 11/24/08. Assessment-viral syndrome. Next day C/O palpitations and feeling out of breath.Prescribed beta blocker but did not take medication. No hospitalization. 1/28/2010 I still have facial flushing, SOB and heart racing everyday. Also, diarrhea and feeling very tired at times. It has been 2 years now and I do not feel ike I did before the shot.				Y					N	11/20/2007	11/21/2007	1	11/14/08-records received- CBC, glucose chemistry panel and TSH normal. EKG-tachycardia with repolarization changes.	PVT	UNK	None	None	None			1						1	Anorexia; Colonoscopy; Computerised tomogram; Diarrhoea; Dyspnoea; Echocardiogram; Endoscopy; Erythema; Flushing; Heart rate increased; Palpitations; Palpitations; Rash macular; Respiratory tract congestion; Vision blurred; Weight decreased; Diarrhoea; Dyspnoea; Fatigue; Flushing; Laboratory test normal; Tachycardia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA323BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA323BA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Emergency room visit	Influenza
0331815	11/10/2008	MA	79.0	79		F	11/06/2008	(1) - (L) vein in neck (collarbone, above) was pounding and heart beat fast (took meds listed in #17) then subsided a little in (1) one HR. (2) - morning after 10/30/08 noticed (L) arm w/ tape at site of injection to date still black/blue (bruised).			Y						U	10/29/2008	10/29/2008	0		OTH	UNK	DIOVAN HCT; IC-Hydrochlorothiazide ; IC metoprolol	No colds, etc.	Allergic to codeine and its additives.			1						1	Heart rate increased; Injection site haematoma; Palpitations	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening	Influenza
0331818	11/10/2008	CA	20.0	20		M	11/07/2008	Pt is 20 yo male with 1 wk progressive weakness in LE's and 2 hx of facial weakness. Weakness is asymmetric, prox > distal. Decreased reflexes throughout. Reports received vaccine at work 1 month ago. Diagnosis GBS. 12/11/08-numbness in fingers and toes began on 1/26/08 then legs achy, leg weakness gait changes.Left Face drooping and twitches. Slurred speech, voice changes, taste different. Unable to perform activities of daily living. Decreased strength and coordination. Areflexia, ascending weaknesses.  Moderate dysarthria. Increased time to masticate foods. Treated with IVIG. Bloodpressure elevated. Asymptomatic parasympathetic dysregulation possibly a cysautonomia in cortex of GBS. Sinus pauses with labile BP/HR.					Y	1			N	10/15/2008	10/26/2008	11	LP Protein, 122; Gluc, 69; WBC, 5.0; No Mg. 12/11/08-records received- MRI brain no gross intraparenchymal mass, hemorrhage or acute infarction. Previously suspected abnormal enhancement of right 6th cranial nerve is not well demonstrated on this current examination. CT scan no abnormality. MRA questionable enhancement of bilateral facial nerves within tympanic and mastoid segments. ECG sinus tachycardia.LP findings consistent with GBS, elevated CSF protein.	UNK	UNK						1						1	CSF glucose normal; CSF protein increased; CSF white blood cell count negative; Facial paresis; Guillain-Barre syndrome; Hyporeflexia; Lumbar puncture; Muscular weakness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89750~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0331821	11/10/2008	NY	53.0	53		F	10/31/2008	Hard, reddened area 2 x 2 cm.  Increased warmth.									Y	10/30/2008	10/30/2008	0	None	UNK	UNK	None	None	Denies			1						1	Erythema; Induration; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA358AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331822	11/10/2008	NJ	28.0	28		F	10/30/2008	Itchiness - arms, back, shoulders, face.  First aid squad called.  Patient refused to be transported to E.R. and signed release.									U	10/30/2008	10/30/2008	0	None	OTH	PVT	None	None	None			1						1	Pruritus	FLU3~SANOFI PASTEUR~U2787EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331824	11/10/2008	TN	26.0	26		M	11/06/2008	5 minutes after administration, arms and legs went rigid; arms/hands turned inward at center of body; head stiff and turned to left shoulder; no response to verbal/tactile stimuli; lasted 30-40 seconds.  Then began talking and was oriented to person, place, and time; sweating.				Y					Y	11/06/2008	11/06/2008	0	EKG at ER normal with pulse of 49.	OTH	PVT	None	None	None			1						1	Electrocardiogram normal; Heart rate; Hyperhidrosis; Muscle rigidity; Posture abnormal; Unresponsive to stimuli	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8811003~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0331827	11/10/2008	OH	66.0	66		F	10/20/2008	Redness at injection site.									Y	10/17/2008	10/17/2008	0		OTH	UNK	Colace, ASA, Simvastatin, Levothyroxin, Metoprdol, KCL, Prozac, Lisinopril/HCTZ	None	PCN			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U2743AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331828	11/10/2008	MD	65.0	65		F	11/09/2008	(Started 10/25/2008)  Severe itching (generalized) over entire trunk, upper/lower extremities.  10/27 itching continued to 10/30/08 (evening) Received prescription at clinic-See enclosed				Y					Y	10/24/2008	10/25/2008	1	On file-clinic	MIL	MIL	None	None	None - I am however allergic to TYLENOL			1						1	Pruritus generalised	FLU3~CSL LIMITED~03149111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0331829	11/10/2008	AK	57.0	57		F	10/21/2008	Received flu vaccine and early afternoon developed bilateral hives to arms/back, shortness of breath, throat tightness. - (10-21-08) Took BENADRYL tablets she has at home and then came to health clinic at 9:30 PM the following day.									Y	10/20/2008	10/21/2008	1	Vital Signs, SAO2, assessment - R.M.T. -	OTH	OTH	BENADRYL, ASA, Lisinopril, Glyburide, Calcium.	None	Allergies -Cold Urticaria history, - Diabetes.			1						1	Dyspnoea; Oxygen saturation; Throat tightness; Urticaria	FLU3~SANOFI PASTEUR~U2807AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331832	11/10/2008	CT	60.0	60		F	11/05/2008	Throat sore felt like lump in throat-3pm. About 1hr later yes blood shot with pus (white). Hives were noted next AM upon waking on right side of stomach- red strip with few off to side. Called MD and was told to take Claridan 10mg as directed. 11/15 hives fading, not itchy.									Y	10/30/2008	10/30/2008	0		PUB	UNK			some seasonal allergy			1						1	Eye discharge; Ocular hyperaemia; Oropharyngeal pain; Sensation of foreign body; Urticaria	FLU3~SANOFI PASTEUR~U2751AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331833	11/10/2008	NC	86.0	86		F	10/30/2008	Reports  itching, redness and warmth at site 10/28/2008.  Blister formed 10/29/2008. Today reddened area measure 120 mm x 100mm.  Blister 45mm x52mm.  Area still appears red at FU									U	10/28/2008	10/28/2008	0		PUB	UNK	PLAVIX;  PILLBaker BHER asa arthistis med (celender);  Ferrowxsituabl	Arthurts;  41BP heart probles				1						1	Injection site erythema; Injection site pruritus; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89621~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331834	11/10/2008	IL	84.0	84		F		Patient was administered a flu shot on 10/15/2008. Patient came in on 10/26/2008 and showed me her arm which was bruised in the deltoid area of her left arm. Pt stated she developed bruise 2-3 days after getting shot. Pt. said bruise is healing still as of 10/28/2008.									U	10/15/2008	10/17/2008	2		OTH	OTH	Plavix	None	Pt on blood thinner-Plavix			1						1	Injection site haematoma	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331835	11/10/2008	ID	23.0	23		F	10/21/2008	3 red welt, arm warm to touch , painful 3 or 4/10									N	10/07/2008	10/18/2008	11	None	OTH	OTH	None	None	None			1						1	Pain in extremity; Skin warm; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA356BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331836	11/10/2008	CO	61.0	61		F	11/03/2008	Oozing eyes, difficulty breathing , hives.									Y	10/30/2008	10/31/2008	1		PVT	UNK						1						1	Dyspnoea; Eye discharge; Urticaria	FLU3~SANOFI PASTEUR~U2809AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331837	11/10/2008	KY	61.0	61		F	10/31/2008	Swelling in arm and pain following administration.  Dr. diagnosed her with phlebitis and prescribed Bactrim DS & Prednisone.				Y					U	10/29/2008	10/29/2008	0	She did a Doppler ultrasound	OTH	PVT		None	None			1						1	Oedema peripheral; Pain in extremity; Phlebitis; Ultrasound Doppler	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331838	11/10/2008	OH	76.0	76		M	11/01/2008	Patient stated his arm and shoulder (left) hurt when moved. He also had trouble gripping with the left hand. Patient came back to report trouble on 10/28/2008. Treated 10/29/2008 at the hospital. He said the diagnosis was tendonitis. On 10/31/2008 patient was contacted to find out how he was doing. Patient stated it was feeling better.				Y					U	10/01/2008	10/02/2008	1		OTH	UNK		none				1						1	Grip strength decreased; Musculoskeletal pain; Pain in extremity; Tendonitis	FLU3~CSL LIMITED~02049111A~UNK~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0331839	11/10/2008	LA	4.0	4		M	11/04/2008	Broke out in welps.  Friday evening 10-31-08 after receiving FLUMIST that day BENADRYL given welps continues X days. Now better.  Notified office 11-3-08									Y	10/31/2008				PVT	OTH	None	Tinea Capitis	None			1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500553P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0331840	11/10/2008	TX	44.0	44		F	10/30/2008	Pt. presented with tightness in chest feeling shaky and redness on chest, face and arms. Patient vitals taken at 1038, 166/94 81 100% (RA). Patient placed in bed and monitored, at 1115. Pt's vitals 130/84 70 98% (RA). Examined patient, patient stated feeling better.				Y					Y	10/30/2008	10/30/2008	0	1038- 166/94 , 81 100%, 1045-156/88, 1115-130/84 70 90%	OTH	OTH			Hypothyroid			1						1	Chest discomfort; Erythema; Heart rate normal; Oxygen saturation normal; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89124~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0331841	11/10/2008	CA	53.0	53		F	11/03/2008	Throat swelling and chronic cough for over half an hour, hives during coughing episode.  Nauseated feeling, loss of voice, shortness of breath.  Voice returned next day.  Scratchy throat for three days.  No treatment sought.									Y	10/28/2008	10/28/2008	0		PVT	PVT	Glyburide; Levothroid; Metoprolol; Nortriptyline; Lisinopril; Buspirone; Metformin; Nambutone		(Allergic to sulfur, adhesive tape, sulfonylureas); Obesity; PVD; Deg cervical disc; DM2; Sleep apnea			1						1	Aphonia; Cough; Dyspnoea; Nausea; Pharyngeal oedema; Throat irritation; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88C45~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331842	11/10/2008	FL	36.0	36		F	11/03/2008	24 hrs. after receiving flu zone 0.5ml IM. Pt presented with 3.5x2 cm swelling, redness, and pain at injection site (left deltoid). Entire arm was sore and felt nausea and hot/cold flashes. Had stinging pain with left arm movement and rad to left hand. Temp 98 degrees. Treated with Keflex and to follow up with PCP or ER.									Y	10/29/2008	10/30/2008	1		OTH	PVT	ASA; hydrochlorothiazide; metoprolol	none	Paxil (swelling face); CVA (@33); Left Ovary teratoma (@27) & HTN (@2 )			1						1	Body temperature; Feeling cold; Hot flush; Injection site erythema; Injection site pain; Injection site swelling; Nausea; Pain; Pain in extremity	FLU3~SANOFI PASTEUR~U28311AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331843	11/10/2008	GA	64.0	64		F	11/04/2008	Pt awoke at 2:30 am with hives on back, buttocks and legs. Palms of hands and hives were itchy.  Eyes were swollen.  Pt administered 2 BENADRYL quick dissolve strips.  itching resolved in 10-15 minutes.  Within 1 hr remainder of symptoms resolved and pt returned to sleep.									Y	11/03/2008	11/04/2008	1	None	PUB	PVT	None	No	Pt reports similar reaction three times in previous year to unknown allergen.			1						1	Eye swelling; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2807AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331844	11/10/2008	NC	25.0	25		F	11/04/2008	Diarrhea X 3.  Took Imodium 10-31-08.  Swollen, tender lymph node under left arm.  Going down now.  No fever.  Mild nausea on 11/3/08.									Y	10/31/2008	10/31/2008	0	N/A	PVT	PVT	Loestrin, Zyrtec, Naproxen sodium	None	Cats			1						1	Axillary pain; Diarrhoea; Lymphadenopathy; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA372AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331845	11/10/2008	TX	14.0	14		M	11/04/2008	App. 20 min. after receiving vaccine, pt. c/o burning chest pain w/difficulty breathing.  V/S: 148/96 R-20 P-82, clear breath sounds and auscultation arteriorly and posteriorly, no rash, c/o tingling to both hands.  Had pt. breathe in paper bag with no relief.  Client stated CP too bad to ambulate, EMS called & pt. transported to local hospital. Pt. released same day from ER, DX: pleurisy.				Y					Y	11/04/2008	11/04/2008	0		OTH	UNK	None	None known				1						1	Burning sensation; Chest pain; Dyspnoea; Paraesthesia; Pleurisy	FLU3~SANOFI PASTEUR~U2790BA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2561AA~UNK~UN~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0331846	11/10/2008	MN	0.8	0	.8	F	11/03/2008	Patient given 0.5cc, adult dose of Preservative-free FLUZONE									Y	10/28/2008			None. Parent called next day - reported no adverse reaction or illness.	PUB	PUB		None	None			1						1	Incorrect dose administered	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B12AA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2797CA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF241AC~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~808702C~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0331849	11/10/2008	MA	19.0	19		F	11/06/2008	(L) shoulder pain after shot (immediately) then resolved after a few days, then recovered, now persists. 1 month after vaccine.									N	10/02/2008	10/02/2008	0	xray shoulder within normal limits	PVT	PVT		None	None			1						1	Immediate post-injection reaction; Injection site pain; X-ray limb normal	FLU3~SANOFI PASTEUR~U2808AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331850	11/10/2008	CO	43.0	43		F	11/10/2008	Patient said arm became numb 5 min. after vaccination and returned to work.  Returned in 30-40-minutes to report numbness, had patient sit and observed for 20-30 minutes, at which time said numbness fading.									Y	10/29/2008	10/29/2008	0		UNK	PVT		None				1						1	Hypoaesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA187AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331852	11/10/2008	IA	60.0	60		F	11/07/2008	Pain in right arm near shoulder, says pain radiates downward. Unable to move arm above head.				Y					U	10/23/2008				UNK	UNK	PRILOSEC					1						1	Injected limb mobility decreased; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0331854	11/10/2008	VT	40.0	40		F	11/10/2008	Pain in arm where the injection was given. Tx=Ibuprofen - one time  400mg. Hurt for 3 days.									Y	11/06/2008	11/06/2008	0	None	OTH	OTH	None	None	None			1						1	Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~87877~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331855	11/10/2008	TN	86.0	86		F		3 pm 10/30/08 Sister phoned stating Pt does not feel good at all. States pt's face is very flushed, P-100, R-44 and feeling very anxious. Pt vomited. Denied SOB, wheezing, hives, paleness or dizziness. Pt advised per Dr to use TYLENOL and rest. May also take BENADRYL.									Y	10/30/2008	10/30/2008	0	None	PVT	PVT	PLAVIX; ASA; LOTRAL CAPTOPRIL; TOPROL XL; SIMVASTATIN;	None	None			1						1	Anxiety; Feeling abnormal; Flushing; Heart rate increased; Respiratory rate increased; Vomiting	FLU3~SANOFI PASTEUR~U2745AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331856	11/10/2008	MA	8.0	8		U		10-23-08 Pt received  Fluvax and PPV23 in RA -10-27-2008 seen for c/o 24 degree redness, swelling, tenderness @ injection site- recommend ice, diphenhydramine prn with effect.  Given PPV23 because only received 2 doses PCV7- History asthma-									Y	10/23/2008	10/26/2008	3		PVT	PVT		No	None			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2831AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1679U~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331859	11/10/2008	GA	50.0	50		F	11/03/2008	pt. noticed are was bruised, tender to touch, it was reddish in color and swollen, warm to touch. Area was very painful.									Y	10/29/2008	10/30/2008	1	None	PUB	PVT	None	None	None		GA09094	1						1	Contusion; Erythema; Local swelling; Pain; Skin warm; Tenderness	FLU3~SANOFI PASTEUR~U2807AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331866	11/10/2008	DC	60.0	60		M	11/05/2008	10/18/2008 presented to ED with cellulitis arm, put on followed up in ED 10/19 and 10/20/08.				Y					Y	10/16/2008	10/17/2008	1	WBC  on 10/18/2008 - 12.0, 86.4 segs ;  WBC on 10/19/2008, 10.9, 79.0 segs;  WBC 10/20/2008, 7.4, 72 segs	OTH	OTH		Cellulitis @ injection site	HTN;  Seizure DIS;  PUD - all -> Erythromycin and Chromotin		2008001	1						1	Cellulitis; Neutrophil percentage increased; White blood cell count increased	FLU3~SANOFI PASTEUR~U2752AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~08030~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331873	11/10/2008	MS	19.0	19		M	11/10/2008	102.4 Fever, Sore throat, aches and muscle weakness									U	11/07/2008	11/09/2008	2		UNK	UNK	none	none	none			1						1	Muscular weakness; Oropharyngeal pain; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331874	11/10/2008	FL	65.0	65		F	11/10/2008	Patient reports exacerbation of cough, increased mucus and respiratory symptoms with fever 4-5 days after influenza vaccine. Still has symptoms. Has not seen MD. Taking OTC cough syrup and Tylenol.									U	10/10/2008	10/14/2008	4	None	PUB	PUB	Lisinopril and Prevastat	Had symptoms of respiratory illness 1-2 weeks prior to vaccination.	Hypertension  Hyperlipdemia			1						1	Condition aggravated; Cough; Pyrexia; Respiratory disorder; Rhinorrhoea	FLU3~SANOFI PASTEUR~U2789AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0224X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331875	11/10/2008	MN	46.0	46		F	11/10/2008	This healthy 46-year-old received a flu shot around 10:30 a.m. this morning.  Around noon she developed a dry, hacky cough, mild headache and body aches.  She took some cold medicine thereafter developing a feeling of palpitations and mild shortness of breath.  Now at 5:30 p.m. those two symptoms have resolved, but she feels very achy, has very red, irritated, itchy eyes, a fever and congestion.  She does note in retrospect that she did have some body aches this morning upon waking.  No known exposures.  No previous reaction to flu shots.  No history of egg allergy or other comorbidities.									Y	11/06/2008	11/06/2008	0	none	UNK	UNK						1						1	Cough; Dyspnoea; Eye irritation; Eye pruritus; Headache; No reaction on previous exposure to drug; Ocular hyperaemia; Pain; Palpitations; Pyrexia; Respiratory tract congestion	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331876	11/10/2008	FL	65.0	65		M	11/10/2008	Client reports pain in left shoulder near injection site beginning 2 days after immunization. Pain and tenderness increased through 3rd and th day. Still has pain with certain movements and tendernees. Denies swelling,redness or induration. States feels like when he had a torn muscle. Took Tylenol. Also reprots exacerbation of flu symptoms, increase, cough, Mucus, slight fever 4-5 days after immunizations recieved.									U	10/10/2008	10/12/2008	2	Had Melanoma removed from left posterior Shoulder 10/03/08.	MIL	PUB	None	Recent Surgery	Hx colon CA, Melanoma			1						1	Condition aggravated; Cough; Influenza; Injection site pain; Pyrexia; Rhinorrhoea; Tenderness	FLU3~SANOFI PASTEUR~U2789AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0224X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331879	11/10/2008	SC	77.0	77		F	11/10/2008	Received flu and pneumonia vaccine on 10/20/08.  C/O pain in injection site (LA) immediately.  Continued to be painful with radiation under arm to L breast area.  Vomiting on 10/21/08--reported to ER on 10/21/08.  Swelling, redness @ site.  Patient requested both given in L arm. Patient has signed release of record form to get hospital records for further medical information regarding this incident. 11/18/08 Reviewed hospital medical records of 10/21-10/24/2008. FINAL DX: cellulitis left shoulder; right shoulder pain secondary to fall at home; & acute gastroenteritis w/dehydration Records reveal patient experienced nausea, vomiting & weakness x 2 days.  Injection site edema, erythema, warmth & pain which extended into left anterior chest wall.					Y	4			Y	10/20/2008	10/20/2008	0	Unknown  LABS: WBC 13.5, neutros 90.1%, lymphs 1%.  Urine c/s (+) Klebsiella pneumonia.	UNK	UNK	Unknown	None	Allergies: sulfa  PMH: GERD, hiatal hernia, pancreatitis, gasteoenteritis, arthritis, CHF.		SC0815	1						1	Breast pain; Immediate post-injection reaction; Injection site erythema; Injection site pain; Injection site swelling; Vomiting	FLU3~SANOFI PASTEUR~U2765AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1679U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0331880	11/10/2008	MN	48.0	45		F	11/10/2008	Left upper arm swelled up and lymph glands in left axilla became swollen and painful.  Chills alternating with sweats and headache and nausea.									Y	10/29/2008				PVT	UNK						1						1	Axillary pain; Chills; Headache; Hyperhidrosis; Lymphadenopathy; Nausea; Oedema peripheral	FLU3~CSL LIMITED~03249111a~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0331882	11/10/2008	TX	37.0	37		F	11/10/2008	Got the flu shot around 5pm and around 8:30pm started feeling a little tickle in my throat.  The tickle started getting worse and i started coughing a lot.  Then it seemed like my throat was closing up.  I also started shivering and felt extremely cold (chills).  I began vomiting, my heartbeat was racing, my eyes were real red (on the white part) and watery.  I was also wheezing when i exhaled. I took two capsules of Benadryl and after about 20 minutes my throat felt better.  I was breathing better.  I still had chills and now had a fever of 101.8.  Most of the symptoms subsided but I have remained tired and fatigued feeling.  I have also had low grade fever off and on for 3 days now.  I went to see the doctor on Friday and she believes I did indeed have an allergic reaction to the flu shot.  I am also allergic to codeine and codone.				Y					Y	11/06/2008	11/06/2008	0	no lab test were done after the reaction	PUB	PUB		was not sick or showing signs of illness prior to vaccine.  No one in household was sick either.	allergy to codeine and codone			1						1	Chills; Cough; Fatigue; Feeling cold; Lacrimation increased; Ocular hyperaemia; Palpitations; Pyrexia; Throat irritation; Throat tightness; Vomiting; Wheezing	FLUX~UNKNOWN MANUFACTURER~unknown~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0331883	11/10/2008	SC	14.0	14		M	11/10/2008	C/O fever (103-104 degrees) approximately 24 hours after vaccines and redness and swelling size of baseball in L arm began approximately 24-28 hours after vaccine.  Also child C/O  pain and achiness.  Was evaluated by Dr. Temp 101 degrees at MD office.  Parent states MD advised was allergic reaction to pneumonia vaccine.  Advised treat with Tylenol and rest by private MD.				Y					Y	11/04/2008	11/05/2008	1		UNK	UNK	Pentassa TID, Prilosec QD, Mirolax prn, multivitamin	none	Crohn's Disease			1						1	Hypersensitivity; Injection site erythema; Injection site swelling; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2805AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1679U~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331884	11/10/2008	VT	0.83	0	.9	M	11/10/2008	High fever (103) 10 mins after injection with rash shortly therafter									Y	11/07/2008	11/07/2008	0		PVT	PUB						1						1	Immediate post-injection reaction; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U2783Ca~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331886	11/10/2008	PA	5.0	5		M	11/10/2008	Right upper arm started to swell and became itchy the day after (day 2) receiving menactra vaccine.  No pain.  Right upper arm & 1/2 lower arm swollen on the following day (day 3).									Y	11/03/2008	11/04/2008	1		PVT	PVT						1						1	Oedema peripheral; Pruritus	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U2817AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0331887	11/10/2008	CO	39.0	39		F	11/10/2008	About 3-4 hours after injection, patient began to have a cough and not feel well. Later in the afternoon and into the evening, she reported body aches, fever of 101.2 and a headache. She slept fairly well and woke up the next day feeling ok. No redness or swelling at site of injection.									Y	11/05/2008	11/05/2008	0		PUB	PVT	unk	None reported	Pen V K, Sulfa, e-mycin	denied~ ()~NULL~~In Patient|unk~ ()~NULL~~In Sibling1		1						1	Cough; Headache; Malaise; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2089AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331888	11/10/2008	TN	64.0	64		F	11/10/2008	received PNE/FLU vaccine in right arm and Td in left arm on friday Nov 7,2008.  Pt awakened at 0230am Nov 8th to pain in right arm and redness.  Pt took Tylenol.  Pt states felt better on Nov 9th.  Pt called this morning to report the s/s and we asked her to come to the clinic so we could document our findings.  Her right arm has pinkish streak mid upper arm about 1 in wide by 4 in long. No swelling.  Pt states still painful to touch.  Pt states feeling better today.  Pt instructed to continue taking Tylenol prn pain.  Pt instructed that s/s should resolve fully and she should feel better.  If s/s worsen she needs to call her doctor.  Pt instructed that we will follow up with her in one week.  Pt also instructed to call clinic if any questions/concerns.  Pt voices understanding of above.									Y	11/07/2008	11/08/2008	1		PUB	UNK	ASA 81mg po daily	None noted	NKDA.  Pt takes ASA 81mg po daily			1						1	Erythema; Pain in extremity	FLU3~SANOFI PASTEUR~u2770aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0551x~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|TTOX~SANOFI PASTEUR~u2349cb~UNK~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0331889	11/10/2008	KY	46.0	46		M	11/10/2008	TOTAL BODY RASH, FEVER CONFUSION AND SHORTNESS OF BREATH THAT ALL STARTED IN THE EVENINING AFTER THE VACCINATON									Y	10/29/2008	10/29/2008	0	DR DID NOT SEEK ANY MEDICAL TREATMENT.	UNK	UNK		NONE	DIABETIC			1						1	Confusional state; Dyspnoea; Pyrexia; Rash generalised	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89986~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331891	11/10/2008	OH	56.0	56		F	11/10/2008	Immunized= 11/07/08 @ 11:30 a.m.  Adverse reactions started @ 5:00 p.m.same day. On set reactions were: 1) vomiting, extreme stomach pain, dizziness, headache,heart palipations/ rate  90), high blood sugar: above 300, high BP, low grade fever, chills, nausea and diarrhea.  TREATMENT: 25mg phenergan, pepto bismol, Tylenol, 100mg. Toporol, 1 mg. xanax,  40 mg.prevacid and gas-x,increased Humulog by 30% no appetite( imagine that?) and bed rest and fluids.   SELF MEDICATED..............                                         DAY 2: nausea, dizziness,no appetite, low grade fever and chills.  High BG's, High BP and heart racing.  Runny nose and a little scratchy throat and body aches and weakness.                                         TREATMENT: same as for first day.                                                DAY 3. Nausea, lack of appetite,headache,extreme body aches, cold symtoms and high blood glucose numbers,  Again unable to reduce BGs to under 300.   Increased Humulog by 30%.                                              TREATMENT- ADVIL COLD & FLU OTC medicine.  25 mg Phenergan, 1 mg. Xanax, increased Humulog by 30%,Tylenol.                                          DAY 4. light cold, tired.         TREATMENT.  Bed rest and fluid.  No appetite.									Y	11/07/2008	11/07/2008	0		PVT	UNK		none	diabetes-cornorary artery disease-bi-polar disorder			1						1	Abdominal pain upper; Anorexia; Asthenia; Bed rest; Blood glucose increased; Chills; Diarrhoea; Dizziness; Fatigue; Headache; Hypertension; Nasopharyngitis; Nausea; Pain; Palpitations; Pyrexia; Rhinorrhoea; Throat irritation; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331892	11/10/2008	TX	39.0	39		F	11/10/2008	felt numbness to tongue with slight pressure to throat without difficulty breathing or SOB; also felt buzzed within a few minutes (20 minutes) of receiving flu vaccine; however, did not return to clinic until a little over an hour later									U	11/07/2008	11/07/2008	0	vitals checked every 30 minutes: BT 131/74, P 66, R 16 regular; BP 108/70, P 61, R regular	PVT	PVT	Prozac 20mg 1 PO qd	none				1						1	Feeling drunk; Heart rate normal; Hypoaesthesia oral; Respiratory rate; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA166AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331894	11/10/2008	IA	68.0	68		F	11/10/2008	Developed reaction in deltoid area late 11/08.  Tingling, blistering, redness, very uncomfortable.  This has happened with past flu vaccinations, but not other vaccinations.  Thought reaction was related to thimerosol so requested thimerosol free vaccine this year.				Y					U	10/23/2008	11/08/2008	16		PUB	PUB		None		Local Reaction~Influenza (Seasonal) (no brand name)~NULL~~In Patient		1						1	Injection site discomfort; Injection site erythema; Injection site vesicles; Paraesthesia; Reaction to previous exposure to any vaccine	FLU3~SANOFI PASTEUR~U2789AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331895	11/10/2008	SC	61.0	61		F	11/10/2008	11/3/08--fever 101.5 degrees, chills, edema and erythema and pain to left arm.  suymptoms continued to 11/5/08.  Patient seem by PMD.  Treated with Rocephin 1 gram and Lortab for pain.  11/10/08--selling in the arm is resolved, she is afebrile.  Slight soreness in arm.  She is currently on Augmentin 500 mg po and pain tabs.				Y					Y	11/03/2008	11/03/2008	0		PUB	PUB					SC0817	1						1	Chills; Erythema; Oedema peripheral; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U2765AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1679U~2~IM~LA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2997AA~1~IM~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0331896	11/10/2008	OK	67.0	67		M	11/10/2008	Received telephone call from patient at 9:00 a.m. He states he had a flu and pneumonia shot 11/6/08 at 10:30 a.m. in his left arm.  He states he had a sever reaction to his shot per ER.  He is ok this morning.  He is a little sore and red.  Thursday a little after lunch his left arm became swollen, stiff and sore.  Later he developed weakness and was not feeling well, feeling fluish.  Had headache, sick, dull, arm swollen and red from the shoulder down.  Started chilling late in the afternoon and evening.  States very uncomfortable, and lackadaisical.  Did not want to eat.  Took Advil and went to bed.  When he got up in the night he was unstable on his feet.  Friday the redness extended down his arm to his armpit and was light pink and swollen and very sore.  Stayed in bed till 10 a.m. with a headache.  Did not eat breakfast.  Ate very little lunch just did not feel like eating.  Arm still bright pink.  Called CDC hot line at 6 p.m.  It said if you have a reaction that last past 24 hours you need to see the MD.  He said it was too late to see anyone that night.  Saturday morining arm is still inflamed.  Called clinic and they told him to call the Nurse hot line.  They refered him to an MD.  So midmorning he went to the ER.  This is 48 hours after immunizations.  They said no infection.  Allergic reaction.  Since he had taken the flu shot in the past with out reaction it was probably the pneumonia vaccine.  Gave him a steroid shot in the hip.  Told him not to take the penumonia vaccine again or it could kill him.  Gave him Rx for steroids to get filled on Sunday if not improved.  Sunday morning he was a little better.  Arm still pink but better.  Monday (today) his arm is norm color and he is feeling much better.  Just wanted to let us know he had a severe reaction to the pneumonia shot.  I told him I would report it to VAERS.			Y	Y					Y	11/06/2008	11/06/2008	0	Had blood test for infection and neg.	UNK	UNK	Generic for Zocor 20 mg daily generic for Protonic 400 mg daily ASA 1 mg daily Generic for Cardura 8 mg daily Caltrate D daily, Vit E 400 IU daily, Vit C 500 mg daily, Generic for Lamisil 250 mg daily x 3 months.	None	Quadrupal bipass 9 yrs. ago, Back surgery 5 yrs. ago, In early July had stone removed from bladder. 1 1/2 months ago had basal cell CA removed from forehead. Allergic to Loratab			1						1	Anorexia; Asthenia; Balance disorder; Blood test normal; Chills; Discomfort; Erythema; Headache; Hypersensitivity; Inflammation; Malaise; Musculoskeletal stiffness; Oedema peripheral; Pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~U2772AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0886F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening	Influenza
0331900	11/10/2008	AZ	8.0	8		M	11/10/2008	REDNESS, SWELLING, WARMTH AND TENDERNESS AT INJECTION SITE THE DAY AFTER INFLUENZA VACCINE ADMINISTERED.									Y	11/06/2008	11/07/2008	1		PVT	PVT						1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2734HA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331903	11/10/2008	DE	56.0	56		M	11/10/2008	Felt symptoms within a few hours after vaccine. Had bodyaches, headache, felt like he had a fever which continued through evening. Still felt poorly the next morning(10/31). Felt dizzy in shower, got out and had syncopal episode hitting head on floor. Required transport to ER, cardiac workup, sutures and stated orbital Fx. States symptoms were gone by evening of 10/31.				Y					Y	10/30/2008	10/30/2008	0	Stated blood count was WNL. Has hx of anemia	UNK	PVT	Unknown	No	Pernicious anemia			1						1	Blood count normal; Cardiac monitoring; Dizziness; Facial bones fracture; Feeling abnormal; Feeling hot; Head injury; Headache; Pain; Pyrexia; Suture insertion; Syncope	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA184AA~4~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0331904	11/10/2008	WA	74.0	74		F	11/10/2008	At site of flu injection had approximately 2 1/2 inch diameter redness, swelling, soreness, hardness. Also had hives on upper torso lasting 4-5 days. Felt feverish. Took benadryl.									Y	10/02/2008	10/03/2008	1		PVT	PUB	Actonel	none	Food allergies	3-4 diameter redness, soreness, swelling.~Tetanus Diphtheria (no brand name)~1~59.10~In Patient		1						1	Feeling hot; Injection site erythema; Injection site induration; Injection site pain; Injection site swelling; Urticaria	FLUX~UNKNOWN MANUFACTURER~na~7+~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~na~4~UN~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0331905	11/10/2008	NC	41.0	41		F	11/10/2008	Patient administered flu vaccine in left upper arm. Post vaccine administration patient c/o pain radiating down left arm which she described as tingling.  Pain worse with certain movements of left arm.  Treatment is with abupropin and rest.									U	10/22/2008	10/23/2008	1		UNK	UNK						1						1	Pain in extremity; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA380AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331906	11/10/2008	ID	18.0	18		F	11/10/2008	Localized swelling, tenderness, erythema, fever and chills.				Y					U	11/06/2008	11/07/2008	1	None	PVT	PVT	Seasonale,Xyzal, Nasonex,Ventolin	none	Allergic Rhinitis, History Pneumonia			1						1	Chills; Erythema; Local reaction; Pyrexia; Swelling; Tenderness	FLU3~SANOFI PASTEUR~2550AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1382U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331907	11/10/2008	OR	11.0	11		M	11/10/2008	Day after vaccines developed itchy rash on R and L thigh, L calf and foot. Topical Benedryl applied and 20 min later looked better(hives gone). When mom arrived at school pt complained of chest pressure and headache but no difficulty breathing. Chest hurt when kneeled at Mass, also at that time c/o hard time breathing. But no wheezing. Rash was red w/ white bumps. Thursday and Friday awoke w/ hives.  Given Topical Benedry and hives went away.  No hives Sunday or Monday.				Y					Y	11/05/2008	11/06/2008	1	Oxygen in office was 99%, heartrate was 101. Temperature was 99.0	PVT	PVT	none	none	none			1						1	Body temperature increased; Chest discomfort; Chest pain; Dyspnoea; Headache; Heart rate increased; Oxygen saturation normal; Rash erythematous; Rash pruritic; Urticaria	FLU3~SANOFI PASTEUR~U2756AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB260AA~2~IM~RA~HEP A (HAVRIX)~1|TDAP~SANOFI PASTEUR~C2996AA~1~IM~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1283X~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0331909	11/10/2008	TX	11.0	11		F	11/10/2008	gave a dose of mcv4 on 10.28.08 and on 10.30.08									Y	10/30/2008				UNK	UNK						1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~u2829aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~u2613aa~2~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0331910	11/10/2008	PA	44.0	44		F	11/10/2008	Patient had influenza vaccine on 10/3/08. Three days later, patient reported symptoms of cough, sinus infection, chills, and a urinary tract infection.  Paitent sought treatment for the urinary tract infection and was placed on Bactrim DS 1 tab 2x/day for 10 days.				Y					Y	10/03/2008	10/06/2008	3	N/A	UNK	UNK	unknown	No	N/A			1						1	Chills; Cough; Sinusitis; Urinary tract infection	FLU3~GLAXOSMITHKLINE BIOLOGICALS~N/A~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0331914	11/10/2008	MA	33.0	33		F	11/10/2008	Influenza Vaccine administered in LD on 10/21/08. Patient notified me on Oct. 22 that she had a stiff neck on Rt. side of neck, with fever. Please note inj. was given Lt deltoid. Self adm. Motrin with some effect, she did go to her PCP. She states she has no idea if it was related to vaccine, but thought she would mention it. DPH notified and said to report it as Adverse Event. Norvartis Man. also notified. Stiff neck did continue to improve every day but still present.				Y					Y	10/21/2008	10/21/2008	0	None known	UNK	UNK		None known	None known			1						1	Musculoskeletal stiffness; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89884~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0331915	11/10/2008	AZ	4.0	4		F	11/10/2008	The night of the vaccinations patient ran an unusually high fever of 102.3. I gave her ibuprofen for the fever every 6 hours and the fever would not break but for only a little while and then she would run the fever again. The next morning when she woke up, she was weak and her left arm was extremely swollen and hard, and all red, and she couldn't move it. I took her immediately to the Urgent Care and by the time we got there patient had a blistery rash all over her. Patient also had a viral looking rash too. I was told by the Urgent Care Doctor that she was having a severe allergic reaction to one of the vaccinations and too watch her carefully for any other signs and to give her Benedryl and alternate Tylenol and Ibuprofen every 4 hours, and to get her in to her Pediatrician on Monday. I took her into Doctor on Monday the 20th of October, and patient was still running a fever, now for 3 1/2 days. She was examined and I was told to continue doing wat I was doing. By Wednesday October 22, patient was still running a fever and now was breaking out in hives all over in patches. So I took patient back in to see Dr., and was told to give her Zyrtec every day and we were referred to an allergy specialist. Patient's fever finally broke after 6 days straight. But the hives are continuing at this time and I am still having to give her Zyrtec every day.				Y					U	10/17/2008	10/17/2008	0		UNK	UNK		None	Asthma			1						1	Asthenia; Blister; Hypersensitivity; Injected limb mobility decreased; Injection site erythema; Injection site induration; Injection site movement impairment; Injection site swelling; Pyrexia; Rash vesicular; Urticaria; Viral skin infection	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~~5~~LA~DTAP + IPV (KINRIX)~1|FLUX~UNKNOWN MANUFACTURER~~4~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~GLAXOSMITHKLINE BIOLOGICALS~~2~~LA~VARICELLA (VARILRIX)~1	USA	Emergency room visit	Influenza
0331916	11/10/2008	MN	45.0	45		F	11/10/2008	Approximately four hours after immunization patient began to wheeze with labored breathing. She had the chills, a low grade temp and her eyes became mattery.  She took some benedry and tylenol but vomited them. She called the nse call line and they told her to report this. Then she slept. The next day she felt better.									Y	11/07/2008	11/07/2008	0	None	PUB	PUB		None	unknown			1						1	Body temperature increased; Chills; Dyspnoea; Lacrimation increased; Vomiting; Wheezing	FLU3~SANOFI PASTEUR~U2810AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331919	11/10/2008	MI	52.0	52		F	11/10/2008	RCVD INJECTION 10-15-2008.  BECAME DIAAY THE FOLLOWING DAY AND BECAME MOST SEVERE 3 DAYS POST INJECTION.  WORST DAY I HAD TO STAY IN BED.  DIZZY EVEN WHILE LYING DOWN. HOT AND TINGLY IN SAME ARM AND HAND AS INJECTION.  FOURTH DAY NO DIZZINESS EVIDENT.									Y	10/15/2008	10/16/2008	1	NO TESTS PERFORMED	PUB	UNK	LEXAPRO, COUMADIN, LANTUS SOLO STAR, APIDRA	NONE	ASTHMA, DM2,DVT			1						1	Activities of daily living impaired; Dizziness; Feeling hot; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~---10~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331921	11/10/2008	NY	53.0	53		F	11/10/2008	vaccination at approx 11:45 am, reaction hit approximately 5:00 pm - had to leave work due to reaction. fever, chills, aches and pains, sharp stomach pain, nausea, pain and difficulty breathing. Patient home and in bed at time of this report(7:50pm). consent forms lists immunization as VIS 07/24/08									U	11/10/2008	11/10/2008	0		PUB	PVT	nexium	none	none			1						1	Abdominal pain upper; Chills; Dyspnoea; Nausea; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331922	11/10/2008	NY	50.0	50		M	11/10/2008	severe fatige, aches and pains experienced shortly after immunization. Affect was presumed at time to be caused by existing CFS condition, although effects were unexpected and unexplained. Reaction to immunization by spouse later in day leaves patient to believe effects experienced may be caused vaccination. Vaccination at approximately 11:45 am. Effects occured at approximately 1:30 pm. Effects gone by time of this report (7:00 pm).									Y	11/10/2008	11/10/2008	0		PUB	PVT			CFIDS			1						1	Fatigue; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331923	11/10/2008	OR	56.0	56		F	11/10/2008	flulike sx--undocumented fever, chills, uri symptoms (cough, runny nose), nausea (no vomiting), some loose stools x 3 days									Y	10/21/2008	10/21/2008	0		PVT	UNK			ALLEGRA-D 12 HOUR 60-120 MG ORAL 12HR SR TAB 1T PO Q12H PRN  FLUTICASONE 50 MCG/ACTUATION NASL SPSN 2SP EN QD  OMEPRAZOLE 20 MG ORAL CPDR SR CAP 1C PO QD, 30MIN BEFORE A 'MEAL'  SINGULAIR 10 MG ORAL TAB 1T PO QD FOA  TRAZODONE 50 MG ORAL TAB .5-1T PO QHS PS  HYOSCYAMINE SULFATE 0.375 MG ORAL 12HR SR TAB 1T PO HS F 'URGENCY'  PREMARIN 0.625 MG/G VAGL CREA 'USE 1/2 GRAM INSIDE VAGINA 2 NIGHTS A WEEK'  ESTRADIOL 2 MG ORAL TAB 1T PO QD  PROAIR HFA 90 MCG/ACTUATION INHL HFAA 2PUF PO Q4-6H PRN FOR 'ASTHMA			1						1	Chills; Cough; Diarrhoea; Influenza like illness; Nausea; Pyrexia; Rhinorrhoea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881171p~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0331973	11/10/2008	WA	46.0	46		F	11/10/2008	Fever 101-99 degrees, Red patches of skin on (R) upper arm swelling, and unable to raise arm above head. Also c/o nausea, body aches. Pt. given promethazine 25mg / POTID x 5 days.				Y					U	11/07/2008	11/08/2008	1	none	PVT	PVT	Imitrex, Flonase, Amitriptyline, Lipitor, Zyrtec, floxetine, triamcinolone topical, promethazine, trexlmet, axert, Cortisporin, Frova, Ciprofloxacin-hydrocortisone otic, Vicodin, Lodine XL, Percocet, Flexeril,	None	None			1						1	Erythema; Injected limb mobility decreased; Nausea; Oedema peripheral; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLAISSAA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0868~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2998BA~UNK~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0331974	11/10/2008	WA	51.0	51		F	11/10/2008	Fever, body aches, sore joints, and swelling at injection site. Area of concern (R) upper arm.									Y	11/04/2008	11/05/2008	1	None	PVT	PVT	Estratest 1.25mg - 25mg; Alprazolam .25mg; Zoloft 25.mg	None	Neurofibromatosis			1						1	Arthralgia; Injection site swelling; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA155AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0619X~2~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2998BA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0331975	11/10/2008	WA	18.0	18		M	11/10/2008	19 y.o. male fell and fainted about 3 min. after receiving a flu shot. Pt had chills and cold sweat but awake and was confused. Medics were called and pt was taken to the hospital. No treatment was given by administer.				Y					U	11/08/2008	11/08/2008	0		OTH	OTH	None	None				1						1	Chills; Cold sweat; Confusional state; Fall; Syncope	FLU3~SANOFI PASTEUR~U2853AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331976	11/10/2008	AZ	85.0	85		F	11/10/2008	Redness, swelling and warmth at injection site extending from right axilla to right elbow.									Y	10/08/2008	10/08/2008	0	None	OTH	OTH		None	None			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Lymphadenitis	FLU3~SANOFI PASTEUR~U2809AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0990U~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331977	11/10/2008	KS	62.0	62		F	11/10/2008	skin itchy, red, painful and swollen to the size of a golfball. symptoms resolved on their own.									Y	11/04/2008	11/05/2008	1	None	PVT	PVT	None	None				1						1	Erythema; Pain; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U2802AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331978	11/10/2008	PA	48.0	48		M	11/06/2008	pain, swelling, induration									Y	11/05/2008	11/06/2008	1		PVT	PVT		No	No			1						1	Induration; Pain; Swelling	FLU3~SANOFI PASTEUR~U2752AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~UNKNOWN MANUFACTURER~0978X~UNK~UN~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0331979	11/10/2008	WA	70.0	70		F	11/10/2008	aches only-arm down through hand				Y						10/16/2008	10/16/2008	0		OTH	PVT	WARFARIN; NORVASC; torasemide; DIGOXIN; METFORMIN; FLORCON; BENICAR	None				1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2742AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331980	11/10/2008	WA	7.0	7		M	11/10/2008	(L) deltoid. Symp started 11/7/08.  Redness swelling itching spread from top of shoulder down toward elbow.  Pt given Benadryl symp. resolved by 11/9/08.									Y	11/06/2008	11/07/2008	1		PVT	PUB		None	None			1						1	Erythema; Oedema peripheral; Pruritus	FLU3~SANOFI PASTEUR~U2829AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331981	11/10/2008	WI	47.0	47		F	11/15/2008	2 weeks later arm still painful and stiff. Radiating to armpit and elbow. 1st day thumb spasms. Tx-heat and ROM exercises.									N	10/28/2008	10/28/2008	0	None	PVT	PVT						1						1	Axillary pain; Muscle spasms; Musculoskeletal stiffness; Pain in extremity	FLU3~CSL LIMITED~03549111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0331982	11/10/2008	OH	62.0	62		M	11/10/2008	Cellulitis-started on ATB and KENALOG injection. local redness, swelling-used BENADRYL, ice.				Y					Y	11/04/2008	11/04/2008	0	ER treatment and diagnosis	PVT	UNK		None	None			1						1	Cellulitis; Erythema; Local reaction; Swelling	FLU3~SANOFI PASTEUR~89751~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0619X~2~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331983	11/10/2008	PA	58.0	58		F	11/07/2008	24 hrs later high temperature (101.5) chills body aches, loss of circulation to fingers lasting several hours. Later, elevated temp, body aches, sweats for 4 days then fine									Y	11/01/2008	11/02/2008	1		PVT	OTH	COMBIPATCH 50/250, 2x/wk; PROMETRIUM 100mg a day; Amlodipine Besylate 5 mg/day; TRAMADOL 100 mg a day; aspirin 8 mg/day; WELLBUTRIN SR 100 mg/day	None	penicillin; Erythromycin			1						1	Body temperature increased; Chills; Hyperhidrosis; Pain; Peripheral vascular disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA357BA~2~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0331984	11/10/2008	CO	59.0	59		M	11/10/2008	Patient called the day after shot to say that 2 hrs after giving shot he experienced tightness and pressure across the chest.  He took BP and pulse-BP 124/70 Pulse 130-  state symptoms are minor today.									Y	11/09/2008	11/09/2008	0		OTH	PVT		None	None			1						1	Chest discomfort; Heart rate increased; Chest discomfort; Dyspnoea; Heart rate increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89982~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~0618960~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0331985	11/10/2008	AK	5.0	5		M	11/06/2008	Large area of erythema & swelling from shoulder to elbow on left arm.  Began with 24 hours of administration of vaccine.  Remained swollen and red for 5 days.									Y	11/03/2008	11/04/2008	1	None	PUB	PUB		None Known				1						1	Erythema; Oedema peripheral	FLUX~SANOFI PASTEUR~U2829AA~2~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331986	11/10/2008	MA	1.0	0	1	M	11/04/2008	Had varicella disease post varicella vaccination.									Y	10/24/2007				UNK	PUB	None	No	NKA			1						1	Varicella post vaccine	FLU3~SANOFI PASTEUR~UT2460AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~01850~UNK~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B47442E~UNK~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0331924	11/11/2008	WI	49.0	49		F	11/11/2008	Hives developed on my left elbow on Saturday afternoon.  More hives appeared on my inner forearm on Sunday morning.									Y	11/06/2008	11/08/2008	2	Called drs office on Monday.  Told that hives were unlikely.  Decided against going to urgent care after doing personal research and realizing that hives can be a reaction and that nothing else had changed in my lifestyle.  Treated sites with topical Benadryl.  Hives still present on Tuesday.	PUB	PVT	allopurinol, cephalexin monohydrate, evista, indomethacin, lasix, synthroid					1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~not known~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331926	11/11/2008	NH	51.0	51		M	11/11/2008	Muscle weakness. Fever of 101.9 Shortness of breath Pretty much like extreme sympthoms of the flu Vomiting restlessness									Y	11/10/2008	11/10/2008	0		UNK	UNK	none	none	none			1						1	Dyspnoea; Influenza like illness; Muscular weakness; Pyrexia; Restlessness; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331927	11/11/2008	CT	0.75	0	.8	F	11/11/2008	24 Hours after injection- High fever (103), lethargy, shortness of breath/quick breathing				Y					Y	11/05/2008	11/06/2008	1	chest x-ray	PVT	PVT	None	cold	none			1						1	Chest X-ray; Dyspnoea; Lethargy; Pyrexia; Respiratory rate increased	FLUX~UNKNOWN MANUFACTURER~~1~~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0331928	11/11/2008	NJ				M	11/11/2008	Should pain- cannot lift it and it hurts				Y					U	10/24/2008				UNK	PVT						1						1	Mobility decreased; Musculoskeletal pain	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331929	11/11/2008	VA	39.0	39		F	11/11/2008	Patient developed baseball-sized knot on arm about 30 minutes after receiving the vaccine.  Her arm was very sore, and she developed red streaks down her arm.  She then developed chest pains and shortness of breath.  She went to the ER where they administered medications and sent her home with a prescription of Prednisone.				Y					U	11/10/2008	11/10/2008	0		UNK	UNK	Patient is on Lortab and methadone	None	Allergic to pcn, metronidazole and toradol.  She has slipped discs in her back and has had chronic and recurrent pneumonia and bronchitis.			1						1	Chest pain; Dyspnoea; Erythema; Induration; Mass; Pain in extremity; Skin striae	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89989~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0551x~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331930	11/11/2008	MD	49.0	49		F	11/11/2008	Became cold and clammy, tingly hands - presyncopal.  Was given Decadron and Zantac IV and prescribed oral prednisone and Zantac.				Y					Y	10/29/2008	10/29/2008	0		PUB	UNK			Osteoarthritis, anemia, hypertension			1						1	Cold sweat; Paraesthesia; Presyncope	FLU3~CSL LIMITED~01149111A~UNK~IM~~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0331931	11/11/2008	WI	37.0			M	11/11/2008	swelling of muscle/tissue and joint pain distal to injection site. No cellulitis or s/s of infection noted. No systemic c/o's.  Tx with anti-inflammatory OTC's and ice.									Y					PVT	PVT		None	None			1						1	Arthralgia; Muscle swelling; Swelling	FLU3~SANOFI PASTEUR~U2770AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331932	11/11/2008	TX	61.0	61		F	11/11/2008	Patient reported on November 7th that she was experiencing a prolonged flu-like reaction.  This reaction consisted of fever, runny nose, sneezing, coughing, and sinus infection and began on Oct 10th.  Went to the MD's office three times and was given several different antibiotics.  She is in the beginning stages of feeling better.  She wanted us to inform and document this adverse event.				Y					Y	10/02/2008	10/10/2008	8	blood work indicated that WBC was normal, also had a chest x-ray that was negative for pneumonia.	UNK	UNK	was given doxycycline and avelox to help with infection.  Also, tussionex was prescribed for the cough	none	none			1						1	Chest X-ray normal; Cough; Influenza like illness; Pyrexia; Rhinorrhoea; Sinusitis; Sneezing; White blood cell count normal	FLU3~SANOFI PASTEUR~u2741aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331936	11/11/2008	MD	3.0	3		M	11/11/2008	My son is 3 years and 10 months old born on 12/27/2004. He has been a healthy child till 11/1/08.  On 10/29/08 he had his first Flu Shot. Before giving the shot his blood test was done and everything was found to be normal.  On 11/1/08 when he woke up in the morning his nose was bleeding and i noticed some blood blisters inside his cheeks while brushing. We took him to our primary care physician there they did his blood test and found his platelets to be as low as 1 K . They asked us to take him to emergency.  In Hospital he was diagnosed ITP (Idiopathic Thrombocytopenic Purpura) .  On Admission he was presented with epistaxis, gingival bleeding and petechia (right side of neck and L upper arm). He was hemodynamically stable without active bleeding and was treated with WinRho 75mcg/kg x 1. on HD#2, his plt count droppeded from 5,000 to 3,000 and he had several purpuric lesions around lips, and multiple petichea on distal tongue, posterior pharynx, anterior neck, and proximal to L PIV. He had no change of MS. On HD#3,(11/03), Prednisone therapy was started at 2mg/kg PO x 1, followed by 1mg/kg PO BID On HD#4,(11/04), platelets were unchanged at 3,000. Doctor discharged him and asked to come back on Friday (11/07). He is advised to take orapred (15mg/5ml), 5ml PO BID for 7 days, on friday his platelets count didnot go up still showing 3000 he was admitted again on saturday but before giving any other treatment they did blood test again and it raised to 9000 Platelets, on saturday doctor gave hin IVIG and they suggested that they will do Bone marrow test as they suspect something else might have caused may not be ITP could be lukemia, they didi blood test on sunday and stared giving IVIG second dose his platelets were up by 19000 and on monday it reached to 66000, bone marrow result were negative they found nothing in that and discharged us on Monday.  and asked us to come for regular checkup.  12/31/08 Reviewed hospital medical records of 11/8-11/10/2008. FINAL DX: acute idiopathic thrombocytopenia purpura Records reveal patient experienced epistaxis, gingival bleeding, petechiae, oral intake reduced, UO decreased.  Seen by PCP & plts count 1.  Admitted & Heme/onc consult done.  Tx w/IVF, steroids & WinRho.  Improved & d/c to home on tapering steroids & heme/onc clinic f/u.  11/14/08 Reviewed PCP medical records of 10/29-11/01/2008. FINAL DX: thrombocytopenia Records reveal patient experienced bilateral tender enlarged cervical lymph nodes & reduced oral intake.  Dx w/lymphadenopathy.  RTC 11/1 w/nosebleed & bruise on inside cheeks.  Had recent URI.  Fever, skin rash, lethargic, vomiting.  Exam revealed petechiae on palate, inflammed nasal mucosa w/bloody drainage, cracked lips, petechiae on neck, ears & upper back.  Referred to hospital for admit.				Y	Y	5				10/29/2008	11/01/2008	3	Before Flu shot on 10/29/2008 platelet counts were 187000 and after flu shot on saturday 11/1/2008 platelet counts were 1000  LABS: CBC WNL on 10/29, plts 187K.  Rapid strep test neg.  Repeat CBC on 11/1: WBC 11.8, lymphs 55.8%(H), plts 1.0K	UNK	UNK		No illness	No pre existing condition  PMH: cold s/s 2 wks prior to admit.			1						1	Biopsy bone marrow; Blood blister; Blood product transfusion; Epistaxis; Gingival bleeding; Idiopathic thrombocytopenic purpura; Petechiae; Platelet count decreased; Purpura; Epistaxis; Idiopathic thrombocytopenic purpura; Platelet count decreased	FLU3~SANOFI PASTEUR~U2804AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0331939	11/11/2008	SC	42.0	42		F	11/11/2008	A few hours after receiving the flu shot I experienced facial swelling, lip swelling, elevated blood pressue.				Y					Y	11/08/2008	11/08/2008	0	I went to the Emergency Room where they gave me benadryl and a shot of steriods.  (which I also had a bad reaction to).  They gave me a perscription for a pack of steriods which I am still taking.	UNK	PVT	Singular, Lo_Estrin	None				1						1	Blood pressure increased; Lip swelling; Swelling face	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0331941	11/11/2008	OH	50.0	50		F	11/11/2008	Received vaccination between 10:30 am and 11:00 am.  Around 2:15 pm began to get hoarse, experience difficulty swallowing and breathing.  Palms began to itch.  Admitted to ER around 2:50 pm.  Around 3:30 pm was treated with IV Solu Medrol and Benadryl.  Symptoms lessened and was discharged around 4:00 pm with a course of prednisone and benadryl for the next couple of day.				Y					Y	11/04/2008	11/04/2008	0		PUB	UNK	Toprol, Diovan, Lipitor, Femhart	none	no known allergies, hypertension			1						1	Dysphagia; Dysphonia; Dyspnoea; Pruritus	FLU3~SANOFI PASTEUR~U2839AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331942	11/11/2008	GA	9.0	9		M	11/11/2008	10-16-08 received FluMist, 11-02-08 developed Pnuemomediastinum & first time wheezing. No prior history of asthma. Admitted to hospital Dx: first time Unspecific Asthma with Status Asthmaticus, Pneumomediastinum with extensive bilateral subcutaneous emphysema.  12/16/2008 MR received for DOS 11/2-3/2008 with D/C DX:  Pneumomediastinum. Unspecified asthma with status asthmaticus. Pt presented with fever, cough, neck swelling and chest pain.  PE (+) for bilateral crepitus of the neck. Started on assthma protocol requiring O2 supplementation.				Y	Y	2			Y	10/16/2008	11/02/2008	17	Chest X-ray Labs and diagnostics:  CXR (+) for pneumomediastinum.	UNK	UNK	Synthoid 75mcg qd		Congential Hypothyroidism. PMH: hypothyroid. ezcema. cough.			1						1	Asthma; Pneumomediastinum; Status asthmaticus; Subcutaneous emphysema; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500567P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0331943	11/11/2008	IL	3.0	3		M	11/11/2008	2 days following the Influenza vaccine my son developed a fever of 105 degrees F, lethargy, severe headache, loss of all previously acquired language, verbal and motor tics.  He has diagnosed with post vaccination encephalopathy recently and is still not recovered.								Y	N	11/12/2005	11/14/2005	2		UNK	UNK			iron deficiency anemia			1						1	Aphasia; Encephalopathy; Headache; Lethargy; Pyrexia; Tic	FLU3~AVENTIS PASTEUR~U1499AA~1~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0331944	11/11/2008	CT	39.0	39		F	11/11/2008	Vaccine administered at 1 p.m. At 3 p.m. patient c/o itchy and rash to both arms, left upper arm red and hot to touch, no reaction at injection site, c/o nausea, no respiratory distress. Pt received Benadryl 25 mg PO, and Pepcid 20 mg PO at 3:25.				Y					Y	11/11/2008	11/11/2008	0	None	PUB	PVT	Vitamin A, Metformin 500 mg daily	N/A	Allergic to Codiene, beer, wine, blue cheese, mushrooms; Medical condition = diabetes	localized rash to R forearm~Influenza (Seasonal) (no brand name)~1~38.00~In Patient		1						1	Erythema; Nausea; Pruritus; Rash; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA173AA~2~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0331946	11/11/2008	PA	60.0	60		F	11/11/2008	bilateral arm pain followed by chest pain which was transient.  This was followed by severe pain in her spine which radiated to her legs.  heart rate 80's.  Oxygen saturation 95.  blood pressure high (170'2/90's) but came down.  Over the course of 15-20 minutes symptoms abated and she left the office with minimal back discomfort in good condition.  At no time did she have hives, angioedema or other usual allergic manifestations.  No treatment other than rest and close observation occurred									Y	11/11/2008	11/11/2008	0	none	PVT	UNK	lopressor, lasix, coumadin, proventil, crestor, xanax	none	hypertension, GERD, hypercoagulable state, anxiety, asthma			1						1	Back pain; Bone pain; Chest pain; Pain in extremity	FLU3~SANOFI PASTEUR~u2764aa~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0870x~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331947	11/11/2008	MD	79.0	79		F	11/11/2008	Joint swelling (right knee) with pain, a week after flu shot which was on Oct.21. Now, 3 weeks later, knee is fairly pain-free unless in use, but left shoulder (site of shot) quite painful and lifting left arm over head is difficult.  As I have many allergies, I believe most of the symptoms will disappear within 5 weeks, as other reactions have in the past. At least, I hope they disappear!									U	10/21/2008	10/23/2008	2		PUB	PUB	atacand, synthroid, low-dose aspirin	None	Many allergies/sensitivities, especially to mold.	none~Influenza (Seasonal) (no brand name)~NULL~~In Patient		1						1	Arthralgia; Joint range of motion decreased; Joint swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331948	11/11/2008	CA	9.0	9		M	11/11/2008	NONE									U	11/11/2008	11/11/2008	0	ADMINISTERED ADULT ONLY	PUB	PUB	NONE	NONE	NONE			1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331950	11/11/2008	CA	1.0	1	.0	F	11/11/2008	Received Hep A, Influenza, and PCV7 on 11/5/08.  Had febrile seizure in am of 11/07/08.  See at Hospital ED.				Y					Y	11/05/2008	11/07/2008	2	CBC had WBC 11.9, plt 255, 000 seg 30, lymph 43, bands 7, reactive lymph 13.  Urine and bld culture negative, stool culture negative. perihilar atelectasis on CXR.	UNK	UNK		URI				1						1	Band neutrophil percentage increased; Blood culture negative; Chest X-ray abnormal; Culture stool negative; Culture urine negative; Febrile convulsion; Full blood count; Lymphocyte percentage increased; Neutrophil percentage decreased; Platelet count normal; White blood cell count	FLU3~SANOFI PASTEUR~UR785BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB268DA~1~IM~LA~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~C45152~4~IM~RA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0331951	11/11/2008	CA	14.0	14		M	11/11/2008	NONE									U	11/10/2008	11/10/2008	0	ADMINISTERED ADULT ONLY	PUB	PUB	NONE	UNKNOWN	UNKNOWN			1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331952	11/11/2008	CA	4.0	4		M	11/11/2008	NONE									U	11/04/2008	11/04/2008	0	ADMINISTERED ADULT ONLY	PUB	PUB	NONE	NONE	NONE			1						1	Unevaluable event; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331953	11/11/2008	CA	12.0	12		F	11/11/2008	NONE									U	11/05/2008	11/05/2008	0	ADMINISTERED ADULT ONLY	PUB	PUB	NONE	NONE	NONE			1						1	Unevaluable event; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLA178AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331954	11/11/2008	CA	5.0	5		M	11/11/2008	NONE									U	11/10/2008	11/10/2008	0	ADMINISTERED ADULT ONLY	PUB	PUB	NONE	NONE	NONE			1						1	Unevaluable event; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331956	11/11/2008	OH	47.0	47		F	11/11/2008	I woke up during the night with severe chills that lasted about 2.5 hours.  I could not get warm nor could I stop the shaking or teeth chattering during this time.  Also, especially my neck, back and shoulders joints were very achySite of injection was painful for 4 days. I took Tylenol and finally fell asleep. Upon awaking in the morning, I was very warm and the shaking had finally stopped. The aches were still present.  I am ok now and not sick.  I am a radiographer at this hospital.  I have received the flu shot many times in the past and have never had this type of reaction.									Y	11/07/2008	11/09/2008	2		PUB	UNK	Advil	none	sulfa allergy and asthma			1						1	Arthralgia; Back pain; Chills; Feeling hot; Injection site pain; Neck pain; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331963	11/11/2008	AR	3.0	3		F	11/11/2008	Thrombocytopenia, petechia. Tx - IV Immune globulin.  2/9/09 Received hospital medical records of 11/8-11/9/2008 FINAL DX: thrombocytopenia Records reveal patient experienced mild abdominal pain x 1 week, bleeding gums & petechial rash x 1 day.  Saw PCP & labs revealed dx.  Tx w/IVIG.  Improved & d/c to home w/serial labs.				Y	Y	2			Y	11/03/2008	11/08/2008	5	Monomac, 16.2; WBC, 19.9; Hgb, 10.6; HCT, 31.5: MPV, 4.2; Neutroph, 12.5; Lymphocytes, 70.2; MCV, 75.3; Platelets, 2   LABS: WBC 17.20(H), H/H 10.7/32.4(L)plts 4,000(L).  LDH 1455(H), AST 104(H), ALT 118(H), Total bili ,0.1(L).  EBV IgM & IgG(H).  Blood c/s neg	PVT	PUB	None	None	None  PMH: HA, had been on periactin up until 2 mo prior.  36 wk preemie emergency c-section for fetal distress.  NICU x 3 weeks w/feeding tube.  Mom w/pre-eclampsia			1						1	Blood product transfusion; Lymphocyte percentage increased; Mean cell volume decreased; Mean platelet volume decreased; Neutrophil count decreased; Platelet count decreased; Thrombocytopenia; White blood cell count increased	FLUN3~MEDIMMUNE VACCINES, INC.~500553P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0331964	11/11/2008	MN	31.0	31		M	11/05/2008	5 hours after getting flu shot patient's airway began to close. Rushed to ER meds administered and kept patient overnight.  11/18/2008 MR received for DOS 10/28-29/2008 with D/C DX: Possible allergic reaction to Flu shot, now doing well. The pm of Flu shot pt developed a sore throat, recurrant coughing, SOB and respiratory distress.  Tx with epi and solumedrol with no recurrance of sx.			Y	Y	Y	1			Y	10/28/2008	10/28/2008	0		PVT	UNK	See Back TOPAMAX, Primidone, KEPPRA, LEXAPRO and NExium.	None	See Back. PMH:  Esopahageal reflux.  hyperlipidemia. Mental retardation. Seizure d/o. Hx of Stevens-Johnson Syndrome. Multiple drug and food allergies Mildly mentally handicapped; Epilepsy; Erythema Multiforme; (Allergic to all antibiotics except CIPRO)			1						1	Throat tightness	FLU3~SANOFI PASTEUR~U2760AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0331971	11/11/2008	RI	0.8	0	.8	F	11/11/2008	Crying for 5 hours, fever 102 degrees for 12 hours vomited x one.									Y	11/05/2008	11/05/2008	0	None	PVT	PUB	None	URI	None			1						1	Crying; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~UT2787AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331972	11/11/2008	NY	9.0	9		F	11/11/2008	pt received FLUZONE 11/10/08, came to office for Tx of reaction 11/11/08.  Area where injection given is swollen, red blotches down arm, warm to touch.									N	11/10/2008	11/11/2008	1		PVT	PUB		Red blotches, swelling	None			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Rash macular	FLU3~SANOFI PASTEUR~U2790AA~6~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331995	11/11/2008	VT	42.0	42		F	11/10/2008	Started with muscle aches, temperature @ 11pm was 103.8 degrees decreased 101.8 degrees with Tylenol, started having aches and chills, started sweating, continued with muscle aches and unable to get out of bed next day.									Y	11/04/2008	11/04/2008	0	none	PUB	PUB	NONE	NONE	NONE	TEMP~Influenza (Seasonal) (no brand name)~1~27.00~In Patient		1						1	Activities of daily living impaired; Body temperature increased; Chills; Hyperhidrosis; Myalgia; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AALLA154AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0331997	11/11/2008	CA	3.0	3		F	11/11/2008	Fever 102- 103.7 x 5 days after two.  vaccines given R anterior/lateral thigh red, swollen 6X7 cm area (PNEUMOVAX given at this site).  FLUZONE given L ant/lat thigh				Y					Y	10/21/2008	10/22/2008	1	None	PVT	PUB	None	None	Cerebral dysgenesis with severe development delays.			1						1	Injection site erythema; Injection site swelling; Pyrexia	FLU3~SANOFI PASTEUR~U2829AA~3~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1539U~1~UN~RL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0331998	11/11/2008	CA	6.0	6		M	11/10/2008	Large area of redness and swelling at injection site on (R) posterior arm.									Y	11/05/2008	11/06/2008	1		PVT	UNK						1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~UT2784BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~AHAVB289BA~1~IM~LA~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~1005X~1~PO~MO~VARICELLA (VARIVAX)~1	USA		Influenza
0332000	11/11/2008	AZ	4.0	4		F	11/11/2008	Patient received INFANRIX, IPOL on Lt upper arm 11/3/08.  Parents noticed fever and cramping abd pain in the first 48 hrs.  Noticed redness, swelling at left upper arm > 48 hrs- progressively got worse, developed generalized urticarial rash all over the body.									Y	11/03/2008	11/05/2008	2		PVT	PUB	None	None	None			1						1	Injection site erythema; Injection site swelling; Muscle spasms; Pain; Pyrexia; Rash generalised; Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B084AA~5~UN~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2740AA~3~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0170~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|VARCEL~MERCK & CO. INC.~0957~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0332002	11/11/2008	TX	53.0	53		F	11/11/2008	Dull ache that increases in intensity when arm is used- as in stretching arm out or lifting up or down.  The pain is in left upper deltoid.									U	09/30/2008	09/30/2008	0		PUB	PUB		No	NKA had DNC 1 month before vaccine			1						1	Pain in extremity; Immediate post-injection reaction; Pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8803905~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0332003	11/11/2008	KY	61.0	61		F	11/11/2008	Rash started at injection site on left arm, then appeared on right arm.  Also, patient complained of bodyaches, mild temperature increase and pruritis.									Y	10/14/2008	10/16/2008	2		PVT	PVT	Metformin 850 mg  Furosemide 20 mg Dioran 320 mg  Mecdlizien 25 mg  Actos 4.5 mg  Ultraor  50 mg Famotidine 40 mg Flecainide 100 mg Cartia XT 240/24 hr Hydrocodone APAP 7.5 650 mg Sertraline 100 mg		IVP dye (swelling), Darvon (vomiting), Erythromycin (rash) HTN, hyperlipidemia, diabetic peripheral neuropathy, DM II.			1						1	Body temperature increased; Injection site rash; Pain; Pruritus; Rash	FLU3~SANOFI PASTEUR~U2839AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332004	11/11/2008	NY	51.0	51		F	11/10/2008	2 minutes after IM injection of FLUZONE, Lot U2828AA, patient developed swelling 3 x 3 cm site of injection, intense pruritis, extending shoulder to elbow and increased ASMAY, decreased PEFN.  Treated Benadryl, steroids, cool compress, proventil inhaler.				Y					Y	11/10/2008	11/10/2008	0	PERAD 330,  after Rx increased to 400	PVT	PVT	Asmonex; Albuterol	Asthma	Allergic to IVP dye; Advair discus			1						1	Injection site pruritus; Injection site swelling; Peak expiratory flow rate	FLU3~SANOFI PASTEUR~U2828AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0330432	11/12/2008	CA	17.0	17		M	11/05/2008	Cardiac arrest due to ventricular tachycardia without known cause.			Y	Y	Y	2			Y	10/17/2008	10/21/2008	4	EKG, CXR, ECHO, Cardiac cath, EP Study: All negative; Implantation cardiac defibrillator	PVT	PVT	None	None	Mild episodic asthma; S/P torn ACL			1						2	Cardiac arrest; Implantable defibrillator insertion; Respiratory arrest; Syncope; Cardiac arrest; Cardiac electrophysiologic study normal; Catheterisation cardiac normal; Chest X-ray normal; Echocardiogram normal; Electrocardiogram normal; Implantable defibrillator insertion; Ventricular tachycardia	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U2637AA~2~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500540PV~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|MNQ~SANOFI PASTEUR~U2637AA~1~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2	USA	Life Threatening,Hospitalisation	Influenza
0331285	11/12/2008	WI	12.0	12		F	11/06/2008	Noticed crooked smile 11/02/08, more pronounced on 11/04/08. Call doctors office - went to ER. Diagnosed Bells palsy.				Y					N	10/30/2008	11/02/2008	3	Lyme Disease	PVT	PVT	None					1						2	Facial palsy; Dyskinesia; Facial palsy; Lyme disease	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500569P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|MNQ~SANOFI PASTEUR~U2656AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2	USA	Emergency room visit	Influenza
0331957	11/12/2008		7.0	7		F	11/12/2008	Caused severe asthmatic attack. O2 level of 92. Required emergency treatment sopportive therapy and steriods. One week recovery.				Y					Y	10/31/2008	11/01/2008	1		MIL	MIL	no	no	Asthma			1						1	Asthma; Condition aggravated	FLU3~SANOFI PASTEUR~U2506AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0331984	11/12/2008	CO	59.0	59		M	11/12/2008	About four or so hours after injection severe tightness across chest, rapid heart beat, shortness of breath with exertion.									U	11/09/2008	11/09/2008	0		PUB	UNK	None	None	None	None~ ()~NULL~~In Patient		1						2	Chest discomfort; Heart rate increased; Chest discomfort; Dyspnoea; Heart rate increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89982~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~0618960~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0332029	11/12/2008	FL	7.0	7		M	11/04/2008	The mother called the office 41 minutes after vaccine administration stating the child was covered in hives and that his throat was itchy, scratchy. Advised to activate EMS/911 immediately.			Y	Y					Y	11/03/2008	11/03/2008	0		PVT	PVT	None	None known	None			1						1	Throat irritation; Urticaria	FLU3~SANOFI PASTEUR~U2800FA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0332031	11/12/2008	WY	68.0	68		F	11/05/2008	I had severe chest pain and pressure for hrs.  that evening - I got the shot in the afternoon Oct 23/08									Y	10/23/2008				PUB	OTH		No	No known allergies			1						1	Chest discomfort; Chest pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332033	11/12/2008	MS	45.0	45		F	10/22/2008	Small ulceration, swollen red upper arm warm to touch for about 1 week.  General aches for 2 or 3 days.  No increase in temp.									Y	10/16/2008				OTH	UNK		None	MORPHINE and DEMEROL injection ? to additives			1						1	Erythema; Oedema peripheral; Pain; Skin ulcer; Skin warm	FLU3~CSL LIMITED~01249111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0332034	11/12/2008	NY	49.0	49		M	11/05/2008	A couple days after shot patient began having symptoms of lethargy, aches and pains, tingling of upper body, heat sensation and light sensitivity, low grade temp 96 or 97.				Y					U	10/21/2008	10/25/2008	4	Urine test and blood work on 11/03/08	OTH	PUB	None	None	Pollen			1						1	Blood test; Body temperature decreased; Feeling hot; Lethargy; Pain; Paraesthesia; Photophobia; Urine analysis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA373AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0332035	11/12/2008	OK	17.0	17		F	11/04/2008	10/31/08 by 5:30 L Deltoid red, swollen, tender, hot to touch from elbow to shoulder.  Pain increase to point, client unable to use L arm rest of the evening/night.  For next 2 days, deltoid warm, red, tender.  11-01-08 - Resolved.  Client used TYLENOL for pain.									Y	10/22/2008	10/22/2008	0	None	PUB	PUB	None	None	None			1						1	Injected limb mobility decreased; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pain in extremity	FLU3~SANOFI PASTEUR~U2811AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332036	11/12/2008	OK	54.0	54		M	11/04/2008	10/31/2008 8pm -soreness in right deltoid.  Dizzy & lightheaded.  8:30 pm- chills-fever 9pm- temp 102.3 degrees, Tylenol 9:30 PM Temp 103.1 degrees.  10pm- Fever broke, chills, sweating then fever back up again. 11 pm- More Tylenol 11:50 pm until 48 hrs later continued to have high fever.  Sweating, achiness, ringing in ears & one episode of hallucination.  Continued to alternate Tylenol & Motrin.  Arm & hand swollen.  11-1-08 Benadryl.  Fever over.  Deltoid red/painful.  Arm swollen.  11-3-08- swelling & redness reduced.  11-5-08- resolved.									Y	10/31/2008	10/31/2008	0		PUB	PUB	None	None	Idiopathic Thrombocytopenic Purpura			1						1	Chills; Dizziness; Hallucination; Hyperhidrosis; Injection site erythema; Injection site pain; Oedema peripheral; Pain; Pyrexia; Tinnitus	FLU3~SANOFI PASTEUR~U2811AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332037	11/12/2008	OH	79.0	79		M	11/01/2008	10/08/2008 Patient received FLUVIRIN and PNEUMOVAX administered to left deltoid.  Approximately 15 minutes later developed chest pain, back pain, loss of vision, and weakness lasting 20-25 minutes.  Patient states hospital told him he had a reaction to one of the vaccines probably, other treatment unknown.				Y						10/08/2008	10/08/2008	0	Unknown	OTH	PVT	COUMADIN;  ATENOLOL	None	HTN			1						1	Asthenia; Back pain; Blindness; Chest pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88113~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0619X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332038	11/12/2008	CO	74.0	74		F	10/27/2008	Swelling of arm, difficulty breathing.				Y					U	10/17/2008	10/20/2008	3		OTH	PVT						1						1	Dyspnoea; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~087881~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0867X~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332039	11/12/2008	FL	1.5	1	.5	F	11/04/2008	11/04/08 Information as contributed by patient's mother:  30 minutes post vaccine on 9/26/08 Head tremor, behavior change, also observed by others.  Resolved quickly, (Review of symptoms neg; family history - negative)									Y	09/26/2008	09/26/2008	0		PVT	PUB	None	None	None			1						1	Abnormal behaviour; Head titubation	FLU3~SANOFI PASTEUR~U2753AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB294BA~1~IM~RL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~C80901~2~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0332040	11/12/2008	NJ	65.0			F	11/05/2008	4 Hours after injection, shoulder and upper right arm swelled and aered  making it impossible to rise or sleep with.									Y		01/01/2008			PUB	OTH		No	None			1						1	Insomnia; Mobility decreased; Musculoskeletal pain; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2771AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1384~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332041	11/12/2008	IN	1.02	1	.0	F	10/27/2008	PT. had large knot on left thigh one day after she received shots.  Area was larger than a quarter, red, hard, and hot to the touch.  Did not seem painful for pt.  Was told to give antihistamine and use cold compresses as needed.				Y					Y	10/22/2008	10/23/2008	1	None	PVT	PVT	None	None	None			1						1	Injection site erythema; Injection site induration; Injection site mass; Injection site warmth	FLU3~SANOFI PASTEUR~U2759AA~1~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0917X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C68312~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1000X~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0332042	11/12/2008	WA	4.0			U		Swelling of left lateral thigh. Ice to site.									Y					PVT	PUB						1						1	Injection site swelling	DTAP~SANOFI PASTEUR~C2955BA~5~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2829AA~4~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A1060~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0480A~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1009X~2~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0332043	11/12/2008	IL	41.0	41		M	11/06/2008	1 day fever and vomiting (even after drinking small amounts of water).									Y	10/30/2008	11/01/2008	2		OTH	PVT						1						1	Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332044	11/12/2008	OH	57.0	57		F	11/06/2008	Extreme dizziness followed by nausea.  Most severe Oct. 24, 2008 after I got the vaccine.  I was still dizzy Oct. 25, 2008 but not as bad.  I started to feel less dizziness on Oct. 26, 2008.									Y	10/24/2008	10/24/2008	0	None	PUB	PVT	None	None	Seasonal allergy to ragweed.			1						1	Dizziness; Nausea	FLU3~SANOFI PASTEUR~U2832AA~4~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332045	11/12/2008	CA	53.0	53		F	11/05/2008	Client stated to student nurse very anxious about shots. After receiving vaccine became very light headed. Paramedics on scene and evaluated client.  EMS report done. Client's  B/P low after vaccine 60/40 after 30min of eval B/P went up 102/60. Client signed AMA with paramedics.									Y	11/05/2008	11/05/2008	0	None	PUB	PUB	Only takes Vitamins	No	Fibromyalgia			1						1	Anxiety; Dizziness; Hypotension	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332046	11/12/2008	CA	59.0	59		F	11/05/2008	PT stated she was allergic to the THERMISOL in vaccines.  RN admin. THERMISOL per vaccine.  PT then became anxious-stated she was feeling anxious, feeling faint & dizzy.  Paramedics on site evaluated PT.  Lay her down & elevated feet.  Monitored her vital signs.  Felt better & signed AMA with paramedics.									Y	11/05/2008	11/05/2008	0		PUB	PUB		None	History of Breast Cancer			1						1	Anxiety; Dizziness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~892975P~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332047	11/12/2008	KY	18.0	18		M	11/06/2008	Syncopal episode 15 hours after administration.  Not otherwise ill.  Brief dizzy spell before he passed out.				Y					Y	11/05/2008	11/06/2008	1	CBC- CMP drawn	PUB	UNK	Serovent, Pulmocort, Zyrtec, Singulair	None	Asthma, Allergy			1						1	Dizziness; Full blood count; Loss of consciousness; Metabolic function test; Syncope	FLU3~SANOFI PASTEUR~U2768AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332048	11/12/2008	VA	65.0	65		F	11/07/2008	PNEUMOVAX site very painful during and after injection, (unable to lift arm due to pain).  Developed chills, fever 11/6 (100.6).  No fever since 02:00 11/7/08.  Bruise at injection site (quarter size).  Received pediatric FLUZONE due to allergies.  2 FLUZONE and PNEUMOVAX injections in same arm due to lymphedema (breast ca) other arm.									Y	11/05/2008	11/05/2008	0		PUB	UNK		None	Asthma, Allergies (sulfites/so)			1						1	Chills; Injected limb mobility decreased; Injection site haematoma; Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~UT2788FA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0742X~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332049	11/12/2008	IL	60.0	60		F	11/05/2008	PT developed hives on scalp, face and hands 30-60 minutes after injection.  She did not treat the symptoms & they resolved by the morning of 11/5/08.									Y	11/04/2008	11/04/2008	0		OTH	PVT	Claritin, Levaquin	Respiratory infection				1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332050	11/12/2008	AK	18.0	18		M	10/27/2008	Reported feeling achy / feverish late evening after vaccines.  Took IBUPROFEN around 1-7:30am approximately 12 hrs after vaccination.  At 1:30am had seizure transported to emergency room diagnosed with febrile seizure.  After fever resolved reports feeling normal.  Was released from ER 10/26/08				Y					Y	10/25/2008	10/26/2008	1		OTH	PUB		None	None			1						1	Febrile convulsion; Pain	FLU3~SANOFI PASTEUR~U2807AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2669AA~1~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0332052	11/12/2008	OK	61.0	61		F	11/04/2008	10-29-08 5:00pm R deltoid becomes sore. 9pm R arm becomes tender red, swollen & 3 orange size blotches appear on arm near elbow.  Client takes BENADRYL & TYLENOL.  10-30-08  10-31-08 - Very sore, painful, swollen & fever in arm.  BENADRYL & TYLENOL.  11-1-08 Reduced swelling + pain, 11-2-08 Resolved.									Y	10/29/2008	10/29/2008	0	None	PUB	PUB	None	None	None			1						1	Injection site erythema; Injection site pain; Injection site rash; Injection site swelling; Injection site warmth; Rash macular	FLU3~SANOFI PASTEUR~U2811AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332053	11/12/2008	NH	14.0	14		F	11/04/2008	C/O back pain, pain in arms and legs mouth feels funny was given MENACTRA, GARDASIL and FLUZONE vaccines on same day. Sharp pains and redness to right leg. Temp 101 Generalized body aches and fatigue transient rash to underside of left upper arm that appears hive-like. Med difficulty breathing. Has hit of asthma. Peak flow decreased from 500- 370.				Y					Y	10/29/2008	10/30/2008	1	none	PVT	UNK			Sulfonamides, Penicillin			1						1	Back pain; Body temperature increased; Dyspnoea; Ear pain; Erythema; Fatigue; Oral dysaesthesia; Pain; Pain in extremity; Peak expiratory flow rate decreased; Rash; Urticaria	FLU3~SANOFI PASTEUR~892973P~7+~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0652X~1~UN~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2686AA~1~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0332054	11/12/2008	GA	48.0	48		F	11/05/2008	Developed flu-like symptoms as well as a large fever blister on her lip.									Y	10/24/2008	10/26/2008	2		PUB	OTH						1						1	Influenza like illness; Oral herpes	FLUN3~MEDIMMUNE VACCINES, INC.~500569P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0332055	11/12/2008	NC	11.0	11		F	11/03/2008	3 days after FLUMIST developed fever, myalgias, pharyngitis (strep negative) cough, rhinorrhea.  Ended up with clinical diagnosis of sinusitis on 11/3/08 (11 days post FLUMIST).  Started on AMOXICILLIN.									Y	10/23/2008	10/26/2008	3		PVT	PVT		None	None			1						1	Cough; Myalgia; Pharyngitis; Pyrexia; Rhinorrhoea; Sinusitis; Streptococcal identification test negative	FLUN3~MEDIMMUNE VACCINES, INC.~5005489~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TDAP~SANOFI PASTEUR~C2769AA~1~IM~UN~TDAP (ADACEL)~1	USA		Influenza
0332056	11/12/2008	FL	63.0	63		M		Muscle Pain - Decrease his ability to have full motion.				Y					N	10/01/2008	10/10/2008	9		OTH	OTH						1						1	Mobility decreased; Myalgia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0332057	11/12/2008	NJ	65.0	65		F		Flu like feeling and chills started appx. 8:30 AM on 10/16/2008. On 10/17/2008 hard to pick arm up did not to work. That evening noticed arm bright red and swollen size of her hand, at PNEUMOVAX injection site.				Y					Y	10/15/2008	10/16/2008	1	Blood tests done in E.R.	PUB	PVT	Prevacid	Had MRI with dye 10/14/2008 injection into left hand vein.	Acid reflux, post left mastectomy-BreastCA 2004			1						1	Activities of daily living impaired; Blood test; Chills; Influenza like illness; Injected limb mobility decreased; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~42832AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~09634~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332058	11/12/2008	UT	35.0			F	10/30/2008	localized rash with itching.  No SOB,  no wheezing.  BENADRYL given PO, patient watched for 15 min.									Y				None	PUB	UNK		None	Compazine			1						1	Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~PO~MO~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332059	11/12/2008	CT	61.0	61		F	11/07/2008	Welts appeared on throat from ear to ear w/in 5 hours after flu shot.  A friend suggested it my be form flu shot.  Called MD the next day- hives fading, no TX prescribed.  No other symptoms beside welts, itching.  No previous RX to flu shot.  Recommended that future shot be done by MD.									Y	10/30/2008	10/30/2008	0		OTH	UNK		None	No Allergies			1						1	No reaction on previous exposure to drug; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2751AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332060	11/12/2008	MN	37.0	37		F	11/06/2008	Evening of shot went to emergency room at bottom of her foot then got welts  and fire engine welts all over - in ER until 4AM. Then got worse again. Treated Epinephrine and  Epi-pen and prednisone and Tagamet				Y					Y	10/15/2008	10/17/2008	2	ETC	OTH	UNK	None		None/did have new flavored cream cheese same day			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2758AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332062	11/12/2008	VA	23.0	23		F	11/06/2008	Pt given FLUVIRIN vaccination on 11/05/2008. Started with symptoms of anaphylaxis immediately (within 5 mins.): swelling at site, hives, confusion, dizziness. Did not have reactive airway symptoms. Epil: 1000 1mL injections SQ x1 in clinic, 911 initiated Pt transferred to ER where tx was continued.										11/05/2008	11/05/2008	0	Pt sent to hospital- Dx with anaphylaxis	OTH	PVT	yaz OCP	uncomplicated UTI	unknown			1						1	Anaphylactic reaction; Confusional state; Dizziness; Immediate post-injection reaction; Injection site swelling; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89970~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332063	11/12/2008	VA	39.0	39		F	11/06/2008	Approx 4 hours post vaccine administration, pt. developed scratchy throat, cough, hoarseness, watery eyes.				Y					Y	01/03/2008	01/31/2008	28		PUB	PUB						1						1	Cough; Dysphonia; Lacrimation increased; Throat irritation	FLU3~SANOFI PASTEUR~U2804AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332064	11/12/2008	VA	51.0	51		F	11/06/2008	Approx 4 hours after vaccine administration. Pt. developed throat tightness, soreness (throat), cough, hoarseness, chest tightness.									Y	10/30/2008	10/30/2008	0		PUB	PUB						1						1	Chest discomfort; Cough; Dysphonia; Oropharyngeal pain; Throat tightness	FLU3~SANOFI PASTEUR~U2804AA~2~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332066	11/12/2008	CA	57.0	57		F	11/04/2008	Throat constricted, red eyes, difficulty breathing and swallowing.				Y					Y	10/31/2008	10/31/2008	0		OTH	PVT		No	Allergies in the distant past			1						1	Dysphagia; Dyspnoea; Ocular hyperaemia; Throat tightness	FLU3~SANOFI PASTEUR~U2748AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332068	11/12/2008	IA	14.0	14		M	11/05/2008	Patient received Flu shot 10/20/08 - was feeling tired nausea on 10/21/08, mother called and I notified Dr. on reaction. Pt wasn't running a fever and I explained to the mother on any severe reactions.									U	10/20/2008	10/21/2008	1		PUB	UNK		None				1						1	Fatigue; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~U2760AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0332069	11/12/2008	IN	28.0	28		F	11/03/2008	Flu vaccine given at 4:20 PM on October 28,2008 in (R) deltoid muscle. Approximately 7:00 PM she experienced trouble breathing and her uvula was swollen. She used her inhaler Albuterol and took Benadryl when she got home approximately 9:00 PM and no further problems.									Y	10/28/2008	10/28/2008	0		OTH	PVT	TRIVORA BIRTH CONTROL	Completed Z-Pak for a cold at 10-28-08	Asthma			1						1	Dyspnoea; Enlarged uvula	FLU3~SANOFI PASTEUR~U275AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332070	11/12/2008	ID	59.0	59		F	11/07/2008	Patient experienced inflamed red welts all the way down her arm. Soreness for over a week. *Right arm only*									Y	10/16/2008	10/16/2008	0		OTH	PVT		none	none			1						1	Erythema; Inflammation; Pain in extremity; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~089973~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0224X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332071	11/12/2008	NH	37.0	37		F	11/05/2008	Pt. presented with reddened eyes & generally not feeling well. - T 98'-80-16-130/90.  I had her lay down-rest with cool cloth.  I flushed eyes, - Medicated with Benadryl  25 mg.  45 minutes later, pt. felt better but had achiness all over.  I gave her Motrin 800 mg at 2:30 & she went home.  11-5- I called pt. today to follow up & she said that she vomited X 1-  Temperature maxed at 98.9- & she feels achy all over.  Site of injection is tender & puffy.									Y	11/04/2008	11/04/2008	0		OTH	OTH		No	No			1						1	Body temperature; Heart rate normal; Injection site pain; Injection site swelling; Malaise; Ocular hyperaemia; Pain; Respiratory rate; Vomiting	FLU3~SANOFI PASTEUR~U2763AA~2~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332072	11/12/2008	MI	49.0	49		F	11/03/2008	Called Dr 10-14-08 to report flu symptoms- nausea, fever 100-102, chills, aches, headache.  saw Dr. 10-15- took blood count, gave script for CIPRO and told to take MOTRIN.  Arm was sore & swollen at this visit.  Continued fever, headache, body aches, chills.  Saw Dr. 10-16-08 as arm was very red, sore & swollen with other symptoms.  He gave me antibiotic 3 times as strong as CIPRO, PREDNISONE & ARDAX.  Tylenol #3 for headache after checking my blood count.  I saw Dr.  again  10-18-08 to F/u feeling much better but arm still red & itchy.				Y					Y	10/13/2008	10/14/2008	1	CBC twice	PVT	PVT	MICARDIS ZYNTEC;  SINGULAIR;  ARMANEX;  PATANOL	None	Allergic to PENICILLIN;  SULFA;  AUGMENTIN;  mild asthma			1						1	Chills; Erythema; Full blood count; Headache; Influenza; Oedema peripheral; Pain; Pain in extremity; Pruritus; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89982~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0619X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332074	11/12/2008	CO	55.0	55		F	10/24/2008	Received AFLURIA vaccine at 8:30 AM. At 12:15 PM began to fell fullness in throat. Fullness progressed to difficulty swallowing and facial swelling  went to ED at Hospital.				Y					Y	10/23/2008	10/23/2008	0		PVT	OTH	Estrogen, imultivit, Vitc, CA, Fibercapsol, glucoseamine, Aleve					1						1	Dysphagia; Swelling face; Throat tightness	FLU3~CSL LIMITED~0104911A~7+~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0332075	11/12/2008	MO	58.0	58		F	11/07/2008	Sx from 11/05/2008 through 11/06/2008. Client had c/o fullness, pressure, and pain in (L) chest area. Sx increase when lying down or bending over. She denies any SOB, irregular HR, or edema. All Sx resolved by 11/07/2008.									Y	11/05/2008	11/05/2008	0	None	PUB	PUB	Vivelle Hormone Patch applied 2 x wk.	none	allergy to Ampicillin	flu Sx~Influenza (Seasonal) (no brand name)~~38.00~In Patient		1						1	Chest discomfort; Chest pain	FLU3~SANOFI PASTEUR~U2810AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332076	11/12/2008	NJ	7.0	7		M	11/15/2008	Blotchy redness at injection site beginning less than 5 minutes after administration of VARIVAX.  C/O intense burning.  Gave Benadryl dose orally.  More comfortable (pain gone) and rash nearly gone in < 10 minutes).  No other symptoms.									Y	11/01/2008	11/01/2008	0	None	PVT	PVT	None	None	None			1						1	Injection site erythema; Injection site irritation; Injection site rash; Rash macular	FLUN3~MEDIMMUNE VACCINES, INC.~500568D~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~1155Y~2~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0332077	11/12/2008	PA	4.0	4		F	11/06/2008	Urticaria on chest, eyelid puffiness, upper lip puffiness, no wheeze, tachypnea or desaturation, Rx= Benadryl.									Y	11/05/2008	11/05/2008	0	None	PVT	OTH			Subglottic stenosis, sacral dysgenesis			1						1	Eyelid oedema; Lip swelling; Urticaria	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~ACZ03116AB~1~UN~RL~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~UZ839AA~5~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1084X~2~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1147X~2~UN~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0332078	11/12/2008	CT	62.0	62		F	11/10/2008	Redness at site 3x3 diameter L arm Pneumo vaccine, Sl swelling and tender Temperature 101 degrees Sat-Mon.									U	11/07/2008	11/08/2008	1	None	PUB	PVT		None	None			1						1	Body temperature increased; Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2751AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0555U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332079	11/12/2008	GU	47.0	47		F	10/28/2008	Development of hives to parts of body, neck, chest, abdomen and thighs.  Symptoms (hives) subsided after a day without any treatment provided.									Y	10/20/2008	10/20/2008	0		PVT	PVT		None	None			1						1	Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA172AA~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332080	11/12/2008	VA	4.0	4		M	11/08/2008	Red, blotchy, itchy rash over the site of DAPTACEL injection over the lateral aspect of the R thigh.  Treated with local care, antihistamines as necessary.									Y	11/06/2008	11/08/2008	2		PVT	PVT	PULMICORE; ALBUTEROL	None	No allergies;  Past Hx of ear infections;  Allergic rhinitis;  Bronchospasm			1						1	Injection site rash; Rash erythematous; Rash macular; Rash pruritic	DTAP~SANOFI PASTEUR~C2799AA~5~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2754AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332081	11/12/2008	LA	68.0	68		F	10/27/2008	1 1/2 hr after vaccine c/o some SOB, coughing, felt like throat was tight-lasted about 2 1/2 hrs. Then began with chills which lasted several hrs. Did not seek medical attention. Chills subsided-felt like was having leg cramps. Slept all night, woke up fine and feels well since.									Y	10/24/2008	10/24/2008	0	None	PUB	PUB	Potassium; increased BP Rx; Rx-acid reflux; Rx for urine	None	increased BP; potassium is low; urinary urgency			1						1	Chills; Cough; Dyspnoea; Muscle spasms; Throat tightness	FLU3~SANOFI PASTEUR~U2848AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332099	11/12/2008	MD	28.0	28		F	11/12/2008	Developed hives, pruritus, respiratory distress. Received epinephrine SC, Decadron, Zofran and Benadryl IV, Claritin orally.				Y					Y	11/04/2008	11/04/2008	0		PUB	UNK			Diabetes, hypercholesterolemia			1						1	Pruritus; Respiratory distress; Urticaria	FLU3~CSL LIMITED~01149111A~UNK~IM~~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0332101	11/12/2008	MD	45.0			F	11/12/2008	Within two days I had a sore throat, fever and , chills set in also, and malaise. Angioedema of both eyes occurred on 5,6,&7. I also had a rash on my face, complete loss of appetite, wheezing when breathing, massive mucous drainage.  I had the shot on Monday, Nov 3 and some of the symptoms are still ongoing! I have never had the flu shot in my life and will never get another one.  I am not allergic to eggs - I am allergic to Penicillin.									U				n/a	UNK	PVT	a daily multivitamin	none.	only allergy is penicillin.	same as listed above~ ()~NULL~~In Patient		1						1	Angioedema; Anorexia; Chills; Malaise; Oropharyngeal pain; Pyrexia; Rash; Rhinorrhoea; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFllA192CA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0332103	11/12/2008	NM	56.0	56		F	11/12/2008	PT C/O SORTNESS OF BREATH AND WHEEZING. SWOLLEN, SORE, RED AND WARM TO THE TOUCH VACCINATION SITE. PATIENT CALLED THE DR. ON CALL FOR ADVICE. SHE WAS INSTRUCTED TO FOLLOW UP WITH THE IMMUNIZATION CLINIC THE FOLLOWING MORNING.									Y	11/10/2008	11/11/2008	1		MIL	MIL						1						1	Dyspnoea; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Wheezing; Dyspnoea; Injection site erythema; Injection site swelling; Injection site warmth; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197AA~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~2	USA		Influenza
0332104	11/12/2008	VT	48.0	48		M	11/12/2008	Received flu vaccine at 3:30 p.m., felt chest congestion/wheezing by 5:30 p.m., high fever, weakness and genaeral body aches by 8:30 p.m., fever broke by 3:00 a.m.									Y	11/04/2008	11/04/2008	0		PVT	UNK		none.	none.			1						1	Asthenia; Pain; Pyrexia; Upper respiratory tract congestion; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332106	11/12/2008	CA	23.0	23		F	11/12/2008	local erythema, swelling, fluctuance, induration, occurring within hours of vaccine administration and lasting over two weeks since									Y	10/21/2008	10/21/2008	0	N/A	MIL	MIL	n/a	none	none	local swelling~Anthrax (Biothrax)~1~23.00~In Patient		1						1	Erythema; Fluctuance; Induration; Swelling	ANTH~EMERGENT BIOSOLUTIONS~FAV149~2~SC~LA~ANTHRAX (BIOTHRAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~500549P~1~IN~NS~INFLUENZA (SEASONAL) (FLULAVAL)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB596AA~2~IM~LA~HEP B (ENGERIX-B)~1|SMALL~UNKNOWN MANUFACTURER~UNK~1~ID~RA~SMALLPOX (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~A0221 2~1~IM~LA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0332107	11/12/2008	CA	14.0	14		M	11/12/2008	NONE									U	11/05/2008	11/05/2008	0	ADMINISTERED ADULT ONLY	PUB	PUB	NONE	NONE	NONE			1						1	Inappropriate schedule of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLA178AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332108	11/12/2008	MA	75.0	75		M	11/12/2008	5 hours after immunization feltlike getting Fluheadache sore throat general malaise Tired no fever lasted through next day									Y	11/10/2008	11/10/2008	0	none	PUB	PUB	one anti-hypertensive medication	none	hypertension			1						1	Fatigue; Headache; Influenza like illness; Malaise; Oropharyngeal pain	FLU3~SANOFI PASTEUR~U2840AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332110	11/12/2008	WI	7.0	7		F	11/12/2008	The flu shot was administered on Tuesday morning.  Upon waking on Friday morning, she was covered with welts (hives) that later turned into brillant red rashes.  She also passed-out within 5 minutes of getting out of bed.  She was taken to the hospital were they did bloodwork and an EKG.  They also administerd Benadyl.  The hives had lessened by the time we left the hospital 3hours later.  She was prescribe Benadyl, Loratidine, and Pednisolone.  The hives returned two more times- Friday evening/Saturday early am.  She has had no reoccurring hives since then.				Y					Y	11/04/2008	11/07/2008	3		PVT	UNK	She was taking no other medications at the time.  She does take sodium flouride a couple times a week, but had not taken any recently.	None.  She did have a throat irritation due to having a popcorn hull stuck in her throat.	She has seasonal allergies.  Her primary allergy is to alternaria (outdoor mold).  When she was youger, she had an egg allergy, but she outgrew that allergy.			1						1	Blood test; Electrocardiogram; Loss of consciousness; Rash erythematous; Urticaria	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332111	11/12/2008	NH	50.0	50		F	11/12/2008	Patient describes usual arm muscle soreness for 4 days following flu shot, but also felt unusually fatigued. Arm muscle soreness went away after four days, only to return, then get progressively worse. She reported this perceived vaccine injury on 10/28/08.									N	10/08/2008	10/15/2008	7	Patient has history of spiinal stenosis with cervical fusion. Was in physical therapy for chronic neck and L shoulder pain. Physical therapist feels current r arm pain originating with supraspinatus muscle.	PVT	PVT	Ventolin HFA, Nasacort AQ, Diazepam 5mg as needed for neck spasm.	none	GERD, asthma, basal cell CA, DVT x1, anxiety.			1						1	Fatigue; Myalgia	FLU3~SANOFI PASTEUR~U2908AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332112	11/12/2008	SC	56.0	56		F	11/12/2008	States when received injection, it hurt.  Developed ache in her arm.  Took Aleve, Advil with relief.  No problem using arm.  No swelling, no bruising.									Y	10/22/2008	10/22/2008	0	none	PUB	PUB		none			SC0818	1						1	Injection site pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2828AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332114	11/12/2008	SC	59.0	59		F	11/12/2008	L arm sore--dull ache entire upper L arm X 48 hours.  Took Tylenol--no symptoms after 48 hours.									Y	10/24/2008	10/24/2008	0	none	PUB	PUB	Actagall, Fosamax	none	Autoimmune liver disease		SC 0819	1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2828AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332115	11/12/2008	SC	47.0	47		F	11/12/2008	Slight HA, sore arm.  Awoke next AM feeling nauseous, upper eyelids swollen, and eyes bloodshot.  Did precipitate her migraines, X 2-3 days.  Other than migraines, other symptoms gone after 24 hours.									Y	10/22/2008	10/23/2008	1	none	PUB	PUB	Nortrel, Zoloft, Imitrex prn	none	Migraine headaches		SC 0820	1						1	Condition aggravated; Eyelid oedema; Headache; Migraine; Nausea; Ocular hyperaemia; Pain in extremity	FLU3~SANOFI PASTEUR~U2828AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332116	11/12/2008	NJ	61.0	61		F	11/12/2008	Influenza vaccination administered on 10/29. Client began feeling achy all over on 10/31. Has a history of osteoarthritis, under care of orthopedic and pain management MDs, but stated that this was more intense. Somewhat relieved by Tylenol Extra Strength. No fever or any other local or systemic symptoms. Still felt achy as of 11/11.									U	10/29/2008	10/31/2008	2		PUB	PVT	Tylenol Extra Strength		Osteoarthritis			1						1	Pain	FLU3~SANOFI PASTEUR~U2768AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332117	11/12/2008	MN	39.0	39		F	11/12/2008	sudden onset of fever of 102.4, very sore throat, rapid heart rate, headache, red and swollen eyes within 2 hours of shot. prescribed anti-histamines and advil.  symptons subsided after anti-histamines.									Y	11/11/2008	11/11/2008	0		UNK	UNK	toprol xl 50 mg, aspirin	none				1						1	Eye swelling; Headache; Heart rate increased; Ocular hyperaemia; Oropharyngeal pain; Pyrexia; Eye swelling; Headache; Heart rate increased; Ocular hyperaemia; Oropharyngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U2754AA~4~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0332118	11/12/2008	VA	71.0	0	.5	F	11/12/2008	received flu vaccine 10/22/08. Next day had eruption that spread to entire body, at first urticarial, then maculopapular, involving mouth and eyes, followed by extensive exfoliation, c/w stevens-johnson syndrome										10/22/2008	10/23/2008	1		UNK	PVT	no new	none	sertraline			1						1	Rash maculo-papular; Skin exfoliation; Stevens-Johnson syndrome; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~87877~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332120	11/12/2008	SC	52.0	52		M	11/12/2008	States driving home 4:30 PM, began to feel tickle in throat.  Further he drove, became worse and began having difficult breathing (he did stop to vote).  Had chills , shaky, temp 103 degrees.  Called PMD--advised to take Tylenol/ibuprofen q 2 hours.  When fever broke, increased sweats.  Went to door to get fresh air and passed out (BP 85/60--wife is RN)  No appetite.  Stayed home next day and felt fine.  Returned to work 11/6/2008 with no problems.									Y	11/04/2008	11/04/2008	0	none	PUB	PUB	Nexium	none	none		SC 0821	1						1	Anorexia; Chills; Dyspnoea; Hyperhidrosis; Loss of consciousness; Pyrexia; Throat irritation; Tremor	FLU3~SANOFI PASTEUR~U2828AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332121	11/12/2008	MN	3.0	3		M	11/12/2008	Received flu shot on 11/06/08.  The next day (11/07/08) around 11 am, left arm was hot, red, painful and swollen to 1 inch above elbow. Saw dr around  1 pm and was placed on antibiotics, Benedryl and Tylenol.  On 11/08/08 swelling spread into the chest area and down past the elbow of left arm. Area was hot, red and painful.  Saw Dr.at 11 am on 11/08/08. Placed on steroid medication.				Y					Y	11/06/2008	11/07/2008	1	Blood draw on 11/07/08 & again on 11/08/08.  All cell counts were normal.	PUB	PVT	none	runny nose	occasional wheezing during winters - nebs used			1						1	Full blood count normal; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2789BA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332122	11/12/2008	CA	40.0	40		F	11/12/2008	Pt admitted 11-10 with generalized weakness and numbness to entire body and extremities. MRI , neurology consultation 11/24/08-records received for DOS 11/10-11/14/08-DC DX: Paresthesia. Hiccup. Generalized numbness involved arms, legs, chest and abdomen began on 11/7/08-Weak feeling barely able to weight bear. Unable to urinate or defecate without pushing hard. Seen on 11/8/08 for viral illness. At time of discharge able to move bowels but bladder weakness remains.					Y	4			Y	10/29/2008	11/06/2008	8	11-10 MRI ABNORMAL PREDOMINANTLY CENTRALLY LOCATED HIGH SIGNAL INTENSITY IN THE  CORD EXTENDING FROM C5 THROUGH THE THORACIC SPINE TO THE 11/24/08-records received-MRI abnormal predominantly centrally located high signal intensity in cord extending from C5 through T-12, findings suspicious for acute transverse myelitis.	UNK	UNK	No active medications on file as of 11/10/2008	None	No chronic medical problems, no CAD, DM, HTN, CVA, CA, COPD			1						1	Asthenia; Hypoaesthesia; Nuclear magnetic resonance imaging abnormal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88645~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0332123	11/12/2008	OH	38.0	37		M	11/12/2008	MULTIPLE SCLEROSIS-FLU VACCINE IN JANUARY, AND CAME DOWN WITH MS IN MARCH-HIT ME RUNNING WENT STRAIGHT TO PROGRESSIVE-				Y					N	01/15/2008	03/15/2008	60	MRI CONFIRMED 8 LESIONS ON BRAIN	UNK	PVT	NONE	NONE	NONE	MULTIPLE SCLEROSIS~ ()~NULL~38.00~In Patient		1						1	Central nervous system lesion; Multiple sclerosis; Nuclear magnetic resonance imaging brain abnormal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0332124	11/12/2008	GA	4.0	4		M	11/12/2008	Patient developed hives several hours after receiving flu vaccine which persisted for 30 hours and subsequently resolved.									Y	10/23/2008	10/23/2008	0	None	PVT	PVT	None	None	Mild intermittent Asthma,  tubes for ear infections			1						1	Urticaria	FLU3~SANOFI PASTEUR~42762AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332125	11/12/2008	CA	7.0	7		M	11/12/2008	NONE									U	11/10/2008	11/10/2008	0	ADMINISTERED ADULT ONLY	UNK	UNK	NONE	NONE	NONE			1						1	Incorrect dose administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332126	11/12/2008	CA	10.0	10		M	11/12/2008	NONE									U	11/10/2008	11/10/2008	0	ADMINISTERED ADULT ONLY	PUB	PUB	NONE	NONE	NONE			1						1	Incorrect dose administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLA178AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332127	11/12/2008	WA	8.0	8		F	11/12/2008	On 10 Nov 08, pt administered flu vaccine administered in right arm.  Mother states was more painful than usual.  Noted rash/bruise around injection area.  last night noted redness & vein distention in triceps region. - SOB. Assessed by NP Dykstra; allergic reaction; given benadryl									Y	11/10/2008	11/10/2008	0	none	MIL	MIL	none	none	none			1						1	Dyspnoea; Hypersensitivity; Injection site erythema; Injection site haematoma; Injection site pain; Injection site rash; Vasodilatation	FLU3~SANOFI PASTEUR~U2833AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332128	11/12/2008	CO	12.0	12		M	11/12/2008	PATIENT WAS STANDING AT THE CHECK-OUT AREA AFTER RECEIVING IMMUNIZATIONS, AND FAINTED FALLING BACKWARDS, HITTING THE BACK OF HIS HEAD.  LOSS OF CONSCIOUSNESS WAS ESTIMATED AT APPROXIMATELY 10-15 SECONDS.  PATIENT WAS UNAWARE HE HAD FAINTED BUT WAS ABLE TO VERBALIZE WHERE HE WAS AND THAT HE HAD JUST RECEIVED VACCINATIONS.  HIS COLOR WAS PALE AND HE STATED HE FELT SICK TO HIS STOMACH.  AFTER LYING FOR APPROXIMATELY 10 MINUTES, PT SAT UP.  HIS CONDITION CONTINUED TO IMPROVE, LOOKING MORE AWARE,REGAINING HIS NORMAL COLOR, AND BECOMING MORE VERBAL.  AFTER APPROX 10 MINUTES OF SITTING, PT WAS HELPED TO A STANDING POSITION.  ALMOST IMMEDIATELY, THE PT STATED HE AGAIN BEGAN TO FEEL FAINT AND COLOR AGAIN APPEARED PALE. HE WAS HELPED TO A LYING POSITION, AND VITAL SIGNS WERE CHECKED.  ALL VS WERE WITHIN NORMAL LIMITS. PT HAD NO C/O HEADACHE, NO VOMITING, NO HEAD LACERATION, NO SEIZURE ACTIVITY, NO C/O NECK OR BACK PAIN, AND VS REMAINED WNL.  DUE TO PROLONGED RECOVERY AFTER FAINTING AND RISK OF CLOSED HEAD INJURY SECONDARY TO FALL, PARAMEDICS WERE CALLED.  PT WAS ULTIMATELY TRANSPORTED TO HOSPITAL FOR FURTHER EVALUATION.				Y					U	11/07/2008	11/07/2008	0	UNKNOWN	UNK	UNK	UNKNOWN	NONE	HX OF ASTHMA/WHEEZING			1						1	Head injury; Loss of consciousness; Malaise; Pallor; Syncope	FLU3~SANOFI PASTEUR~U2828AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB243AA~1~IM~LA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2661AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B027AA~1~IM~RA~TDAP (BOOSTRIX)~1	USA	Emergency room visit	Influenza
0332129	11/12/2008	CA	7.0	7		M	11/12/2008	NONE									U	11/10/2008	11/10/2008	0	ADMINISTERED ADULT ONLY	PUB	PUB	NONE	NONE	NONE			1						1	Incorrect dose administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332130	11/12/2008	LA	3.0	3		F	11/12/2008	Pt has been coughing and wheezing since the day after she got her flu mist.									U	11/03/2008	11/03/2008	0	none	PVT	PUB	none	none	none			1						1	Cough; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500553P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0332132	11/12/2008	CA	7.0	7		M	11/12/2008	NONE									U	11/07/2008	11/07/2008	0	ADMINISTERED ADULT ONLY	UNK	UNK	NONE	NONE	NONE			1						1	Incorrect dose administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332133	11/12/2008	CA	31.0	31		F	11/12/2008	Pt given two vaccine in Left arm on 11/10/2008. Has received flu vaccine yearly for last 9 years without reaction. At this time, Also received pnemovax vaccine. Within 24 hours, red, raised area to arm with flu like symptoms consisting of fever, chills, nausea and body aches.									U	11/10/2008	11/11/2008	1	None	PVT	PVT	paxil,buspar oc, singulair, omeprazole	None	None			1						1	Chills; Erythema; Influenza like illness; Nausea; No reaction on previous exposure to drug; Oedema peripheral; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2784AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1382U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332136	11/12/2008	PA	1.42	1	.4	M	11/12/2008	Seizure, high fever, red papular rash consistant with MMR rash				Y					Y	11/10/2008	11/12/2008	2		PVT	PVT						1						1	Convulsion; Erythema; Pyrexia; Rash papular	FLU3~SANOFI PASTEUR~ut2787ca~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1362x~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1222x~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0332139	11/12/2008	FL	40.0	40		F	11/12/2008	I had my flu shot on October 6, 2008.  We held an onsite flu clinic for all staff.  Five weeks later I still have pain in my arm.  It hurts when I reach up or lay on the arm.  The pain is a shooting or jabbing pain.  On a scale of 1  5, it is a 3 (last week it was a 5).  The shot site has no redness or swelling.  Basically I am experiencing muscle pain.				Y					N	10/06/2008	10/06/2008	0		UNK	UNK	Theophylline, Aerobid, Albuterol, Foltx, Lisonpril, Sprintec, Multi Vitamin, Zyrtec	None.	Asthma, allergies (dust, animals, smoke, perfume, plants/tress/flowers), high blood pressure, and Hypoglycemic.			1						1	Injected limb mobility decreased; Myalgia; Pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0332140	11/12/2008	AL	66.0	66		M	11/12/2008	received vaccination at 6 pm. At 10 pm chills, fever, night sweats, frequent urination (hourly), shortness of breath (severe), no sleep. Sleep about 4 am until 8:30 am.									Y	11/10/2008	11/10/2008	0		UNK	PUB		none	HBP	none, disregard~Vaccine not specified (no brand name)~1~~In Patient		1						1	Chills; Dyspnoea; Insomnia; Night sweats; Pollakiuria; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~19515-0885-07~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332141	11/12/2008	CA	13.0	13		F	11/12/2008	Patient was given Gardasil, Influenza Vac and PPD. Few minutes after the injections patient fainted and fell to the floor. Mother and the medical assistant were in room. Patient sustained a laceration to her left upper lip and her one incisor broke. Patient needed treatment for laceration at the emergency room after she was transported by paramedics. She also required dental treatment. Full dental treatment has not been done yet. She has seen the dentist, she had xrays. She needs a crown, a root canal in the affected tooth. 12/11/08-records received for DOS 10/28/08-immediately after receipt of vaccine fainted, fell and broke her upper lip and front left incisor. Fainting a second time. Seen in ED. 12/17/08-ER records received for DOS 10/28/08-syncope-lip laceration. loose teeth.				Y				Y	N	10/28/2008	10/28/2008	0		UNK	UNK		None	Patient is in special classes.			1						1	Fall; Immediate post-injection reaction; Mouth injury; Syncope; Tooth injury; X-ray; Fall; Loss of consciousness; Oxygen supplementation; Suture insertion; Syncope; Tooth injury	FLU3~SANOFI PASTEUR~U2757AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1487U~3~IM~RA~HPV (GARDASIL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~2|HPV4~MERCK & CO. INC.~1487U~UNK~UN~UN~HPV (GARDASIL)~2|UNK~UNKNOWN MANUFACTURER~~UNK~UN~UN~VACCINE NOT SPECIFIED (NO BRAND NAME)~2	USA	Disabling	Influenza
0332142	11/12/2008	CA	13.0	13		F	11/12/2008	NONE									U	11/06/2008	11/06/2008	0	ADMINISTERED ADULT ONLY	PUB	PUB	NONE	NONE	NONE			1						1	Incorrect dose administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|HPV4~MERCK & CO. INC.~0650X~1~IM~RA~HPV (GARDASIL)~1	USA		Influenza
0332143	11/12/2008	CA	6.0	6		M	11/12/2008	NONE									U	11/06/2008	11/06/2008	0	ADULT USE ONLY	PUB	PUB	NONE	NONE	NONE			1						1	Incorrect dose administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ALFFA178AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332144	11/12/2008	CA	4.0	0	.0	M	11/12/2008	NONE									U	11/06/2008	11/06/2008	0	ADULT USE ONLY ON INFLUENZA	PUB	PUB	NONE	NONE	NONE			1						1	Wrong drug administered	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B087BA~5~IM~LA~DTAP (INFANRIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|IPV~SANOFI PASTEUR~A0490~4~IM~LA~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~1079K~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0135K~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0332145	11/12/2008	CA	14.0	14		F	11/12/2008	ADMINISTERED ADULT ONLY									U	11/07/2008	11/07/2008	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332146	11/12/2008	IN	50.0	50		F	11/12/2008	Patient states her eyes started itching and burning at approx. 10:30 a.m., 2 1/2 hours after flu shot was administered.  At 11:00 a.m., at the start of her lunch, she reported her throat tightening and was having trouble breathing. 911 was called and she was taken to ER.  The ER doctor dismissed the allergic reaction being caused by the flu vaccine.  However, the next day, patient was seen by her primary doctor and he told her the reaction was caused by the flu vaccine and told her to not receive the vaccine in the future. She reports her lunch was familiar foods and that she did not eat anything unusual. 11/13/08-records received for DOS 11/6/08-presented to PCP office day after vaccine and visit to ED. Two hours after receiving flu shot tongue was swelling and C/O SOB. Seen in ED examined and no treatment rendered. PE in PCP office normal. Assessment: Flu shot reaction.			Y	Y					Y	11/05/2008	11/05/2008	0		UNK	UNK		None known	NKA reported			1						1	Dyspnoea; Eye irritation; Eye pruritus; Hypersensitivity; Throat tightness	FLU3~SANOFI PASTEUR~U2791BA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0332147	11/12/2008	UT	4.0	4		F	11/12/2008	red, inflamed area under nose; painful reaction to runny nose.									U	11/12/2008	11/12/2008	0		PVT	UNK	NONE	NONE	NONE			1						1	Erythema; Inflammation; Pain; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~1~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0332149	11/12/2008	MO	51.0	50		M	11/12/2008	myelitis, left leg numbness and weakness, started 9 days after influenza vaccination.  Syndrome confirmed by neurologist and neurosurgeon.  Treatment: Steroids				Y					N	10/31/2008	11/08/2008	8	T and L spine MRI, Nerve conduction velocity testing to R/O GBS.  Exam by neurologist and neurosurgeon consistent with myelitis syndrome	PVT	PVT	none	none	none	none~ ()~NULL~~In Patient|none~ ()~NULL~~In Sibling1|none~ ()~NULL~~In Sibling2		1						1	Hypoaesthesia; Muscular weakness; Myelitis; Nerve conduction studies abnormal; Neurological examination abnormal; Nuclear magnetic resonance imaging abnormal	FLU3~SANOFI PASTEUR~U27518AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332156	11/12/2008	NY	60.0	60		F	11/12/2008	This case was reported by a healthcare professional and described the occurrence of injection site redness in a 60-year-old female subject who was vaccinated with INFLUENZA vaccine (manufacturer unspecified) and FLULAVAL (GlaxoSmithKline).  Concurrent medical conditions included lactose intolerance and neck pain.  Concurrent medications included SYNTHROID.  In early October 2008, on a day around 09:00 or 10:00, the subject received a dose of FLULAVAL at 0.5 ml in the left arm.  Immediately after vaccination with FLULAVAL, the subject experienced injection site pain that radiated down her arm to her wrist.  As a result of the pain, the subject also had difficulty sleeping and was unable to knit.  The subject also experienced neck pain exacerbation.  The healthcare professional considered the events were disabling.  At the time of reporting the events were worse with the exception of pain radiating down the arm for which the outcome was not specified.  The healthcare professional considered the events were possibly related to vaccination with FLULAVAL, again with the exception of pain radiating down the arm which was not specified.  It was additionally mentioned that the subject experience injection site redness and injection site swelling following an unknown flu vaccination two years prior (2006).  The outcome of the events was not reported.								Y	U	10/01/2008			UNK	PVT	PUB	Thyroxine sodium	Lactose intolerance, neck pain	The subject has previously received flu vaccines.  Two years ago, the subject experienced redness and swelling at the injection site that persisted for an unspecified amount of time following flu vaccine administration.  The flu vaccine given at that time was unknown.  No other adverse reactions have occurred in response to vaccinations in this subject.		A0755234A	1						1	Activities of daily living impaired; Condition aggravated; Immediate post-injection reaction; Injection site erythema; Injection site pain; Injection site swelling; Insomnia; Neck pain; Pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Disabling	Influenza
0332157	11/12/2008	CA	7.0	7		M	10/31/2008	A serious spontaneous important medical event of autistic type symptoms has been received from a consumer concerning a seven-year old male. The patient had a medical history of autism; no concomitant medications were provided. On 16-Oct-2008, the patient received a dose of FLUMIST. On 17-Oct-2008, the patient experienced autistic type symptoms (arms flopping, repeated vocal sounds, more than normal agitation, and unusual movement of his head and neck) one day after receiving FLUMIST. Per the mother, these symptoms have been present for the last two weeks and there was an unsuccessful attempt to reach the patient's physician. Outcome for the events was not provided by the reporter. The reporter thinks that FLUMIST might be the cause of these symptoms.  The following information was received for this case: 1) Pt's date of birth is May 5, 2001. 2) Lot number is not available. This information was submitted on Nov 21, 2008.									U	10/16/2008	10/17/2008	1		OTH	OTH	Not Reported	Autism			MEDI0007435	1						1	Agitation; Condition aggravated; Dyskinesia; Hypotonia; Repetitive speech	FLUN3~MEDIMMUNE VACCINES, INC.~~1~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0332159	11/12/2008	VA	17.0	17		M	11/12/2008	45 hours after receiving the vaccine, my son had a lung collapse while sitting in class. He was sent by ambulance to hospital where he was diagnosed with a spontaneous pneumothorax. He had a chest tube inserted. After 7 days, without healing, he was sent to another hospital.  5/11/09-Medical records received for DOS 11/3/08 to 11/7/09. FINAL DIAGNOSIS: Resolved Pneumothorax Transferred to this hospital, after stepping on chest tube, for definitive management of persistant pneumothorax.  Air leak. Decreased breath sounds on right, chest pain. Fever, tachycardia.					Y	12			Y	10/25/2008	10/27/2008	2	X-rays; CT scans  5/11/09-Medical records received for DOS 11/3/08 to 11/7/09. LABS and DIAGNOSTICS:  CBC - Mildly elevated white count. CHEST PA/LAT - small right apical pneumothorax. Small pleural effusion. CT PE DVT PROTOCOL - Tiny apical pneumothorax, bubbles around chest tube within pleural space. Basilar pneumothorax resolved. Right pleural effusion. No evidence of deep vein thromobosis.	MIL	MIL	None	None	None			1						1	Chest tube insertion; Collapse of lung; Pneumothorax	FLUN3~MEDIMMUNE VACCINES, INC.~500563P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0332162	11/12/2008	CT	70.0	70		F	11/10/2008	Presented with severe weakness, lower back pain, and inability to ambulate to DCH ED 10/12/08. Hx stroke 1 yr. ago and has had progressive weakness since that time .  Approx. 2 weeks ago she was unable to get up, swallow, and SOB with minimal activity. Seen by neurologist who felt presentation consist with Guillain Barre Syndrome. Influenza vaccine given on 10/01/08 records received 11/17/08-for DOS 10/12-10/20/08-DC DX: Guillain-Barre syndrome. Presented with severe weakness lower back pain, unable to ambulate. PMH: stroke 1 year ago and since that time has had weakness which has been getting progressively worse, 2 weeks ago became suddenly worse to point unable to get up, unable to swallow, shortness of breath with minimal activity. Transferred. 11/24/08-records received for DOS 10/21-10/29/08-DC DX: Guillain Barre. CAD. Diabetes Mellitus Type II, HTN, hypothyroidism. Treated with IVIG.					Y	16			U	10/01/2008	10/12/2008	11	10/12/08 CT Head w/o contrast, no acute process; CXR - Negative. 10/20/08 EMG - finding was consistent with polyradiculoneuropathy with marked abnormal features in addition to degenerative features  records received 11/17/08-MRI spine moderate spinal stenosis, CT normal. EMG studies consistent with Guillain-Barre, polyradiculoneuropathy with marked axonal features in addition to patchy demyelinating features.   11/24/08-records received-LP CSF protein 63.	PVT	PVT	Unknown	Unknown	Stroke records received 11/17/08-PMH: stroke 1 year ago.PMH: hypothyroid, chronic low back pain, dyslipidemia, asthma, obesity, coronary artery disease, DVT, type 2 diabetes, IBS, hyperkalemia, hypomagnesemia. 40 pound weight loss over past year.		CT200813	1						1	Abasia; Asthenia; Back pain; Chest X-ray normal; Computerised tomogram normal; Dysphagia; Dyspnoea; Dysstasia; Electromyogram abnormal; Guillain-Barre syndrome; Scan brain	FLU3~SANOFI PASTEUR~U2833KA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0332163	11/12/2008	MT	56.0	56		F	11/21/2008	None stated									U	11/10/2008	11/10/2008	0		PUB	PVT	BONIVA	None	NKDA			1						1	Inappropriate schedule of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA367CA~1~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0224X~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332164	11/12/2008	OK	68.0	68		F	10/24/2008	Red rash, swelling, itching and soreness of right arm from injection site to above (R) elbow after PNEUMOVAX (L) administration. Pt received PNEUMOVAX injection on 10/15/08 at about 5pm. Pt developed and experienced soreness, itching and rash at 10pm that night. Reported reaction 10/17/08				Y					Y	10/15/2008	10/15/2008	0	Pt saw a physician at urgent care; dx possible cellulitis	OTH	OTH						1						1	Injection site erythema; Injection site pain; Injection site pruritus; Injection site rash; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~09614~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332165	11/12/2008	CA	39.0	39		F	11/12/2008	On 10/30 I got the flu shot on 10/31 my body was a little sore on 11/1 my head hurt so bad I could not get out of bed. I was dizzy and I was very nauseated and was vomiting. My doctor refuses to say that I was reaction to the flu shot.				Y					N	10/30/2008	10/31/2008	1	I went to the Dr 4 time and the ER did a CT Scan that was normal.	PVT	PVT		None/Sprain Ankle	None			1						1	Activities of daily living impaired; Computerised tomogram normal; Dizziness; Headache; Nausea; Pain; Vomiting	FLUX~UNKNOWN MANUFACTURER~Unknown~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0332166	11/12/2008	KS	82.0	82		F	11/12/2008	Chills, body aches, headache, temperature (101 degrees) Yellow nasal drainage										11/05/2008	11/05/2008	0		PUB	PUB		None	None			1						1	Body temperature increased; Chills; Headache; Pain; Rhinorrhoea	FLU3~SANOFI PASTEUR~U2810AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332169	11/12/2008	CA	71.0	71		F	11/12/2008	Gave FLUVIRIN instead of PNEUMOVAX 23.									U	11/12/2008	11/12/2008	0		OTH	OTH	None	None	None (say coronary heart disease)			1						1	Wrong drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89994~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332171	11/12/2008	OR	0.6	0	.6	F	11/12/2008	Temperature to 104 degrees (ax) at home <24 hrs after vaccine. vomiting lacy reticular rash on extremities.				Y					U	11/11/2008	11/11/2008	0		PVT	PVT			Gastroesophageal reflux			1						1	Body temperature increased; Rash; Vomiting	DTAPIPVHIB~SANOFI PASTEUR~C2881AA~1~UN~LL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~UT2783EA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0062X~2~UN~LL~HEP B (RECOMBIVAX HB)~1|PNC~PFIZER\WYETH~C99642~1~UN~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0332172	11/12/2008	KS	30.0	30		F	11/12/2008	Rash at site, itchy. Cold compresses.									Y	11/07/2008	11/08/2008	1		UNK	UNK	None	None	NKDA			1						1	Injection site pruritus; Injection site rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA151AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332173	11/12/2008	KS	76.0	76		F	11/12/2008	(L) arm raised welt with heat and flushing down (L) arm halfway. Was given Depomedrol 80 mg IM.									Y	10/30/2008	10/30/2008	0		PUB	UNK		None	Septin, Talwin, Amoxicillin, Macrodantin			1						1	Flushing; Skin warm; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA151AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332175	11/12/2008	KS	13.0	13		F	11/12/2008	Mother states pt. after getting FLUMIST approx 1 hr. later starter experiencing diarrhea & vomiting, states she had the injectible flu immunization in yrs. passed & not had any s/s after injection.									N	11/04/2008	11/04/2008	0		PUB	PUB	None	was well when given shot	None	07/10/2008~Meningococcal (no brand name)~1~13.00~In Patient		1						1	Diarrhoea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500560PVFC~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB260AAVFC~2~IM~LA~HEP A (HAVRIX)~1	USA		Influenza
0332176	11/12/2008	CO	55.0	55		F	11/11/2008	Swelling @ injection site + 3 days, then decreased range of motion in shoulder joint and pain in L shoulder (aching, joint pain), not improving even with IBUPROFEN 1600mg/day									N	10/22/2008	10/22/2008	0		OTH	OTH	LISINOPRIL	None	Arthritis (hands)			1						1	Arthralgia; Injection site swelling; Joint range of motion decreased; Musculoskeletal pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89620~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332177	11/12/2008	NJ				F	11/10/2008	I noticed allergy symptoms way out of control and I slept much more than usual.									U	10/22/2008				OTH	PVT		Unknown	Unknown			1						1	Hypersensitivity; Hypersomnia	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~AR~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332178	11/12/2008	NJ				F	11/07/2008	I had discomfort for 10 days.  I was unable to lift my arm for almost a week.  I am relieved to hear that others experienced the same symptoms.  The arm is still sore.  I would like to know if the shot was administered correctly or if it was the vaccine.									N	10/22/2008				OTH	PVT		Unknown	Unknown			1						1	Discomfort; Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332182	11/12/2008	PA	47.0	47		F	11/12/2008	Fatigue, weakness, body aches, shortness of breath, eyes blood shot and face flushed. Pt received shot at 10AM and came to center at 16:45. Pt Received EPI 1:1000 and IM, Benadryl 25 mg IM. Felt better then rebounded over the next hour. Received Benadryl 50mg IM x EPI 1:1000 SC solumerol 125.				Y					Y	11/03/2008	11/03/2008	0		UNK	UNK			Iodine;Cipro; Codeine; food allergies, ic strawberries, tomatoes			1						1	Asthenia; Dyspnoea; Fatigue; Flushing; Ocular hyperaemia; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0332183	11/12/2008	NY	17.0	17		M	11/12/2008	Mom states- last night subject was shaking turned blue, alert oriented, vomited and felt better, no fever-  Had flu shot rashes in the day? if it was from the shot.									Y	11/11/2008	11/11/2008	0		PVT	PVT		None	Amox allergy			1						1	Cyanosis; Rash; Tremor; Vomiting	FLU3~SANOFI PASTEUR~U2853AB~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332184	11/12/2008	FL	55.0	55		F	11/12/2008	Rash bilateral arms and feels flushed to neck, arms, chest and legs.  To ER.  Bronchospasms x 1/2 hr.  ER - IV - Solumedrol, Benadryl and Epinephrine.  Then Steroids x 4 days and Zyrtec TID, Zantac TID and Benadryl PRN.  In ER x 2 hours.				Y					N	11/11/2008	11/11/2008	0	Always had allergies.  Has been in a hypersensitive mode having 3 reactions in 3 weeks.	PUB	PUB	Unknown	None	Allergy to PCN and others (always had).			1						1	Bronchospasm; Flushing; Rash	FLU3~CSL LIMITED~1949111A~4~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0332185	11/12/2008	MA	15.0	15		F	11/12/2008	Caused hives on left arm (short site) and red rash on chest									Y	10/23/2008	10/26/2008	3		PVT	OTH		None	DM 2 over wt HTN Dyslip OA			1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~02829AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332186	11/12/2008	FL	47.0	47		F	11/12/2008	Client received FLULAVAL 3:42 P.M. 11/10/08. At 3:34 on 11/10/08-client reported feeling weak, lightheaded and was unable to walk, sitting on floor at hallway of store. I found client to be lethargic with generalized weakness. No angioedema, swollen lips, tongue and uvula. No urticaria or erythema. No wheezing, Lung CT. A Bilaterally.3:44pm ran b/p 170/110, pulse - 92, Resp - 20, Temp - 98.5. 911 called and Paramedics sent client to ER for evaluation at 3:47PM 11/10/2008.				Y					Y	11/10/2008	11/10/2008	0		PUB	PVT	VERAPAMIL	None	TIA'S HTN, SEIZURES, MIGRAINE HEADACHES			1						1	Abasia; Asthenia; Dizziness; Hypertension; Lethargy	FLU3~GLAXOSMITHKLINE BIOLOGICALS~A166AA~6~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0332187	11/12/2008	IN	43.0	43		F	11/10/2008	Several (5-6) bumps (shingle like) in small area surrounding injection site- Very itchy (continues 4 days later). Does not feel well- no fever no appetite.									Y	11/07/2008	11/08/2008	1		PUB	PVT		None	None			1						1	Anorexia; Injection site rash; Malaise; Pruritus; Rash vesicular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA169AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332188	11/12/2008	IN	39.0	39		F		Started having sore R arm Friday PM.  Had fever of 104 degrees Saturday.  Went to Hospital ER 11/9 AM.  Said she had 2 IV's with antibiotics. Was informed she had; Bacteria in her Blood- Not UTI.  Is on AUGMENTIN - 11/12/08 still has 4 inch round inflamed area surrounding pneumonia injection site.				Y					Y	11/07/2008	11/07/2008	0		PUB	PUB		No	None			1						1	Bacteraemia; Injection site inflammation; Pain in extremity; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA169AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0868X~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332189	11/12/2008	PA	65.0	65		F	11/12/2008	Pt states that approximately 2-3 hrs after receiving PNEUMOVAX during the Monday 11/10/08 Immunization clinic, pt's could not lift R arm and R arm was sore. Today, 11/12/08 patient states arm is fine now									Y	11/10/2008	11/10/2008	0	None	PUB	UNK	Unknown	None	None			1						1	Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~2757~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1538U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332190	11/12/2008	TX	0.7	0	.7	F	10/16/2008	Was given VAQTA instead of RECOMBIVAX HB									Y	10/16/2008				PVT	OTH	None	None				1						1	Wrong drug administered	FLU3~SANOFI PASTEUR~AHAVB297AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~~1~IM~RA~HEP A (VAQTA)~1	USA		Influenza
0332191	11/12/2008	TX	55.0	55		F	11/12/2008	Rec'd FLULAVAL on 11/7/08.  Noted on Tuesday, 11/11/08 upon awakening that she was itching, noted whelp on chest, back, arms, face, buttocks, thighs (back) states her POP was not able to see here 11/11/08 + did go to ER, just stayed at home, did not take med.  except routine meds.  Reported to OHC 11/12/08.				Y						11/07/2008	11/11/2008	4	See by physician assistant and referral to primary care physician.	MIL	MIL	AMLODIPHINE;  BENAZEPRIL 20mg twice a day	None	Blood pressure			1						1	Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197AA~4~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0332193	11/12/2008	WI	49.0	49		F	11/12/2008	Pt called to report yesterday received the FLUZONE vaccine at 3:30PM. She states at 7PM yesterday she felt throat closing up, was coughing and had some wheezing. States took Benadryl 50mg by mouth at 7:30PM and Albuterol Inhaler 2 puffs at 7:45PM. -No other medication taken. Next day (today) has a little sore throat and HA. She did not seek medical.									Y	11/11/2008	11/11/2008	0		PVT	PVT	None		Reflex			1						1	Cough; Drug hypersensitivity; Headache; Oropharyngeal pain; Throat tightness; Wheezing	FLU3~SANOFI PASTEUR~UZ798EA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332194	11/12/2008	IL	49.0	49		F	11/12/2008	AFLURIA given 11/10/2008 slight itching that night next AM rash generalizes itching took Benadryl 50mg 11/12/2008 AM had severe itching hives all over welts. MD Rx Epi 13 at Decadron 1.5ml.									Y	11/10/2008	11/10/2008	0	none	PVT	OTH	none	none	none			1						1	Pruritus generalised; Rash generalised; Urticaria	FLU3~CSL LIMITED~01249111A~7+~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0332196	11/12/2008	IA	1.0	1	.0	F	11/10/2008	Shots given 10/22/08, 10/31/08 t 101.2 pt on Amox for an Rash began 11/2/08 saw Dr. 11/3/08 suspect secondary to MMR, 11/4/08 saw Dr., wheezing; - dehydrated,  Febrile illness with URI CXR done 11/6/08 labial furuncle started pt on Bactrim.									Y	10/22/2008	10/31/2008	9	None	PVT	PVT		(R) Otitis Media	NKOA			1						1	Dehydration; Furuncle; Pyrexia; Rash; Upper respiratory tract infection; Wheezing	FLU3~SANOFI PASTEUR~2782FA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0224X~1~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1208X~1~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0332197	11/12/2008	WV	12.0	12		M	10/29/2008	No adverse event. GSKAFLLA173AA State Supplied Adult. FLULAVAL labeled for adult use only administered in error to a 12 year old.										10/27/2008	10/27/2008	0		PUB	PUB		NONE	NONE		WV0837	1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA173AA~2~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1|MNQ~SANOFI PASTEUR~U2661AA~1~IM~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~UF452CA~1~IM~UN~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1015X~1~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0332198	11/12/2008	PA	2.0	2	.9	M	11/11/2008	Pt become pale color drained from lips placed him on bed- within 1 min Pt got color back.									Y	11/11/2008	11/11/2008	0		PVT	PVT		NONE	NONE			1						1	Pallor	FLU3~SANOFI PASTEUR~UT2782AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332205	11/12/2008	TX	46.0	46		F	11/12/2008	Pt. developed some swelling in area of (L) neck/Parotid. In no distress. On 11/6 pt. had some redness at injection site (R) deltiod									Y	11/03/2008	11/04/2008	1		PVT	PVT						1						1	Injection site erythema; Local swelling; Parotid gland enlargement	FLU3~SANOFI PASTEUR~U2806AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332206	11/12/2008	IA	66.0	66		F	11/10/2008	Rt arm red circular rash 6 x8 inches. Hives systemically -no itch- fever up to 101 degrees little relief with Tylenol- swollen- painful into under arm and breast area. Monday still 6 x 8 circular, headache too, rash painful- fever decreased to 99 degrees. Cellulitis and put on Antibiotics, Not able to take Antitictamines, ocepinphrine, lcartisma.				Y						11/07/2008	11/07/2008	0		PVT	PVT		none			IA08017	1						1	Cellulitis; Erythema; Headache; Oedema peripheral; Pain in extremity; Pyrexia; Rash; Urticaria	FLU3~SANOFI PASTEUR~UZ758AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1161X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332207	11/12/2008	NJ				F	11/07/2008	Patient said I wanted to let you know that I'm having an experience similar to someone I know though my mobility limitations aren't quiet as severe. My shoulder has been sore and painful since the FLUZONE vaccine on 10/24/2008. I saw my primary care physician yesterday and she said it's either an inflammation from the shot or that the shot hit a tendon. She prescribed an anti-inflammatory drug and if that doesn't help then I'll need to see an orthopedist.										10/24/2008				UNK	UNK						1						1	Inflammation; Injected limb mobility decreased; Musculoskeletal pain	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332208	11/12/2008	NJ				M	11/07/2008	Patient informed me last week that he was still experiencing pain in his arm and felt that I should know.										10/22/2008				OTH	PVT		Unknown	Unknown			1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332209	11/12/2008	NJ				F	11/07/2008	Patient said I got a flu shot here on 11/24 and since then, have lost mobility of my left arm. It turns out the shot was given in my tendon (a few inches too low). I have to go to an orthopedic doctor now to work on getting mobility back. I can barely drive. I need to report this to the clinic that came here too. You might want to think twice about this clinic coming back next year. Do you have their contact info? I need to reach out to them A.S.A.P.									N	10/24/2008				OTH	PVT		Unknown	Unknown			1						1	Activities of daily living impaired; Injected limb mobility decreased; Wrong technique in drug usage process	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332210	11/12/2008	NJ				F	11/07/2008	Thank you. I can't even say it's discomfort. I'm at the point of excruciating pain depending on how I move it, lay on it, or even what I do. I planned on going to my doctor but unfortunately I' in the middle of a two day radioactive thing for my thyroid and my time is limited and I'm not allowed to take certain medicines or have tests done until this is finished. Ugh! Anything you can find out would be greatly appreciated. I would add for me that I started to have some slight improvement but then ever since Saturday things have been the worst the have been for me ever since I got the shot. So much so that certain movements bring such intense pain that I feel as if my shoulder may be broken and the pain can bring me to both screams and tears. I actually have an appt. with my doctor later today and I am going to take __________ as well who is still having discomfort but not always to the same degree as mine. I too greatly appreciate this investigation because something is just not right. I have gotten this shot every year I have been there and never had a problem. After this reaction, I will never get another flu shot.										10/22/2008				OTH	PVT		unknown	Unknown			1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332211	11/12/2008	NJ				M	11/07/2008	Just wanted to let you know that I still have a lot of pain in my left arm from the flu shot.  There are some days when I have trouble lifting things.  Hurts when I lift my arm up high.  I've been taking Motrin as needed but it's been 2 weeks since the shot.  I'll go see my doctor in a few days if needed.  Thank you for your attention to this matter.										10/22/2008				OTH	PVT		Unknown	Unknown			1						1	Joint range of motion decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332213	11/12/2008	NJ				M	11/07/2008	Probably not related, but I did come down with a cold about 2-3 days after the shot; just thought I'd let you know.									U	10/22/2008				OTH	PVT		Unknown	Unknown			1						1	Nasopharyngitis	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332219	11/12/2008	NJ				F	11/07/2008	A couple of days after, my arm was extremely sore and hot and I couldn't lift my arm above the height of my shoulder.										10/22/2008				OTH	PVT		Unknown	Unknown			1						1	Feeling hot; Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332228	11/12/2008	NJ				F	11/07/2008	Glad to know I'm not the only one and that they're taking a look into the matter. The injection site was sore for three days or so but then the discomfort went into the upper part of my arm. Today which is two weeks after the shot my arm remains achy and I'm unable to lift and twist it a certain way. It's the tri-cep and bi-cep muscles that hurt, not the injection site itself. Within the last four days I noticed that the arms was swollen and appeared bruised. Advil helped with the discomfort but when it wore off the discomfort was/is still there. Last night I applied a moist heat heating pad to it on and off. I was at the doctor's yesterday for another issue and he did look at my arm for me. I asked if it could have been a reaction to the shot - he said he wasn't sure. I am on an antibiotic for the other issue- he thought that might help with swelling.									U	10/22/2008				OTH	PVT		Unknown	Unknown			1						1	Contusion; Injection site pain; Joint range of motion decreased; Myalgia; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332229	11/12/2008	NJ				F	11/07/2008	My entire upper arm has ached continually since I had the shot and I have sharp pains in the muscles in much of my upper arm when I move it. I can barely lift the arm on its own. The pain keeps me awake at night and makes it difficult to even change positions in bed due to the sharp pains the movement causes. I spoke to my doctor's office last week and they instructed me to take Advil every 4 hours and use moist heat on a regular basis. I've been doing that since but it has not helped. They were referring to the injection site, so I am not sure they understood how bad the symptoms are. I was going to give it until the end of this week and make an appointment to get checked if still not improved by then. Just a follow-up to my e-mail of yesterday. Today is really bad. I now have swelling in my upper arm along with the pain (I'm talking shoulder to elbow upper arm) and feeling a strange sensation. King of a tingling with cold or hot, I can't figure out which. One thing that seems to be a common denominator from those I've compared notes-Where she gave the shot and where she put the band-aid were not the same. The shot was higher than the band-aid. I'm beginning to wonder if she simply missed where she was supposed to inject and that is why we are having problems.										10/22/2008				OTH	PVT		Unknown	Unknown			1						1	Feeling of body temperature change; Injected limb mobility decreased; Myalgia; Oedema peripheral; Pain in extremity; Paraesthesia; Sleep disorder	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332231	11/12/2008	NJ				F	11/07/2008	Pain in my arm muscle was the only side effect that I didn't have.  Almost exactly one hour after receiving the flu shot my glands started to fell swollen, I became achy all over, and I felt a little feverish although I did not register a fever.  This lasted for about a day and a half, and then chest congestion set in.  I had a loose cough, and then it moved north to my nose and sinus congestion.  I'm still feeling minor lingering effects, but the symptoms are just about gone.  I've been taking the flu shot for five years and have never had a reaction before, although I do know that each year contains different strains.										10/22/2008				OTH	PVT		Unknown	Unknown			1						1	Feeling hot; Lymphadenopathy; Nasal congestion; Pain; Productive cough; Respiratory tract congestion; Sinus congestion	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332232	11/12/2008	NJ				F	11/07/2008	Arm pain										10/21/2008				OTH	UNK		Unknown	Unknown			1						1	Pain in extremity; Injected limb mobility decreased; Pain in extremity; Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2787EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U27870~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~U27870~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA		Influenza
0332233	11/12/2008	NJ				F	11/07/2008	Arm pain.										10/21/2008				OTH	UNK		Unknown	Unknown			1						1	Pain in extremity; Immediate post-injection reaction; Injection site pain	FLU3~SANOFI PASTEUR~U2787EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2787EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0332234	11/12/2008	NJ				F	11/07/2008	Patient has never had FLUZONE before. Several days after immunization she began to experience increased pain. The pain is constant and is sore to even move her arm to do simple ADLs. She denies redness swelling; warmth; or fever. Patient said she began to have symptoms or a Upper Respiratory infection several days after the injection, but it has since become a productive cough with annoying coughing spasms. I advised her to contact her primary care physician, and to call us with the outcome.										10/14/2008				OTH	PVT		Unknown	Unknown			1						1	Activities of daily living impaired; Pain in extremity; Productive cough	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332235	11/12/2008	NJ				F	11/07/2008	Patient said she had a FLUZONE on October 14th.  Patient said she had normal achiness for the first day or two following the injection. She has had many years of flu shots and has never experienced a problem with them. After initial achiness of this past dose on 10/14, she began experiencing increasing pain. She has difficulty sleeping; putting clothing on the site; and moving her arm. She denies redness; swelling; warmth; and fever. I advised her to contact her primary care physician and to call us with the outcome.										10/14/2008				OTH	PVT		Unknown	Unknown			1						1	Activities of daily living impaired; Injected limb mobility decreased; Insomnia; Pain	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332236	11/12/2008	NJ				M	11/07/2008	I'm, still experiencing very strong pain that limits the movement of my arm while I'm at work and that wakes me up repeatedly at night. The hot compresses help very temporarily and the pain returns minutes later. ADVIL doesn't seem to mute the pain either. The pain is an intense, sharp ache that travels down my upper arm but not past my elbow. The pain is always there and is aggravated by movement of my arm. Changing positions at night causes intense pain if I have been, in any degree, sleeping on the affected arm. If I haven't been sleeping on it changing positions still causes enough pain to wake up and delay my returning to sleep. At work I leave my left arm ( the affected arm) resting on my desk and mostly use my right to do anything that might require me to lift my left. I will use the left in some cases ( because I can't spend my day using one arm solely) but with sharp, aching pain as being the price paid. My pain has been consistent and extreme and it began within 12 hours of FLUZONE. Monday, while at work, I felt dizzy and disconnected(similar to how you might feel after taking strong pain medication). It went away and it may or may not be connected to the FLUZONE but I thought I'd mention it anyway. I have considered going to the doctor but have hesitated because I don't have the available finances to be paying the doctor to tell me what you already have suggested. I've been trying the suggestions previously given, without success. I hope something comes of this investigation because I'm beyond ready to have this be over. At least if I stay healthy this winter it may be worth it but at this point, as the pain radiates from my shoulder, that's highly debatable.										10/22/2008				OTH	PVT		Unknown	Unknown			1						1	Dizziness; Feeling abnormal; Joint range of motion decreased; Pain in extremity; Sleep disorder	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332238	11/12/2008	NJ				F	11/07/2008	I still have a large amount of pain when I move that arm in a certain directions and I have been using mostly my right arm since the shot. It is difficult to put on a coat or a shirt. I have to bend totally over to take one off or put one on. Driving is ok. I cannot lift anything with that arm either. There has not been any swelling, bruising or redness in the area of the shot. It feels like it is the joint or the muscle itself. It even aches and has sharp pain occasionally when I am not using it. I have an appt. with a Dr. on another matter on Thursday and intend to ask him what is wrong. I have been applying warm packs and letting the shower run on it to no avail. I cannot take any aspirin, Tylenol or Advil for the pain.										10/22/2008				OTH	PVT		Unknown	Unknown			1						1	Activities of daily living impaired; Arthralgia; Hypokinesia; Myalgia; Pain in extremity	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332239	11/12/2008	NJ				F	11/07/2008	Arm pain										10/22/2008				OTH	PVT		Unknown	Unknown			1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332240	11/12/2008	NJ				M	11/07/2008	I think that the work you do to bring the flu shot to the office is a great benefit and I do appreciate it as much as I do the heart test. I have to tell you though that I couldn't possibly risk another 2 weeks of pain like I received from this last shot. Youch! It's very surprising to me and I have to believe that it's more a case of misplaced shot than a new mix of vaccine. I'm just guessing really, but my shot was near the top of my shoulder and my pain is sort of in the shoulder itself-not the muscle. Please don't interpret this as a complain in any way 9 I do complain about it as I explain to her why she's raking the leaves and splitting the wood (not really)). I continue to appreciate the effort and concern that you and the company put forth regarding out health. I just wanted to share my experience with you in the even that you continue your dialog with the nurse.										10/22/2008				OTH	PVT		Unknown	Unknown			1						1	Musculoskeletal pain	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332241	11/12/2008	NJ				U	11/07/2008	This is the 6th year I received the flu shot and I have never had a experience like the one I had this year. Within hour of the shot I had radiating pain throughout my upper arm. The pain was very deep and was felt in my armpit and down my side. Every time I moved my left arm it was painful. I thought it was unusual, but I expected it to go away within 24 hours. That was not the case. The pain continued for almost a week. The injection site was also sore to touch for a week also.									U	10/22/2008				OTH	PVT		unknown	unknown			1						1	Joint range of motion decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332243	11/12/2008	NJ				F	11/07/2008	I went to my doctor today. He told me she hit either a nerve, ligament or bursa when she gave me the injection. He thinks most likely a ligament or bursa since the pain when she gave me the injection did not travel down my arm. He gave me a prescription for steroids to reduce the inflammation and wants me to ICE it regularly. Once the inflammation goes down I will need to do exercises to get the range of motion back. I have a follow-up appointment on Monday so he can check if any improvement from steroids.									N	10/22/2008				OTH	PVT		Unknown	Unknown			1						1	Inflammation; Pain; Wrong technique in drug usage process	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332245	11/12/2008	PA				F	11/07/2008	Late afternoon after receiving FLUZONE in my left arm on 10/22/2008, my upper arm started to ache and get stiff but I had no bruising or tenderness in the actual shot area. By that evening, I could not raise my elbow away from my body w/o pain shooting into my biceps, nor could I lift anything up with my left hand- it hurt my arm. It was tough to get dressed, shower and pick up things or carry my children who are 1 & 3 yrs old. I took Tylenol a couple times over the next 3 or 4 days & it eventually went away. On early Sunday morning on 11/01/08, I woke up from a movement that hurt my left arm & took me by surprise. Now my arm hurts all over again two weeks later. It was the same pain & stiffness & I cannot lift my arm outward from my body w/o the shooting pain. I have not seen my family doctor as yet and as of 11/05/05, I am still having the same problem with my arm										10/22/2008				OTH	PVT		Unknown	Unknown			1						1	Activities of daily living impaired; Joint range of motion decreased; Musculoskeletal stiffness; Pain in extremity	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332246	11/12/2008	NJ				F	11/07/2008	I am still having difficulty using my left arm.  The muscle is very sore whenever I lift my arm for any reason.  I have showered with hot water and taken ADVIL but it seems to be only a temporary fix.  I have had the flu shot before but never this reaction.  I also have difficulty sleeping at night on that side.  I have not seen a doctor for this yet.  I keep hoping that the discomfort is only temporary and will go away.  Please let me know if you hear anyhing from the nurse again.										10/22/2008				OTH	PVT	Unknown		Unknown			1						1	Injected limb mobility decreased; Insomnia; Myalgia; No reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332248	11/12/2008	NJ				U	11/07/2008	I have been in a lot of pain since my shot. I can't lift my arm past a certain point without aching. It is tough for me to change my shirt or even wash my hair. I called my doctor but only spoke with the secretary and have not gone in to see her. I a relieved to see it is not just me though.										10/22/2008				OTH	PVT		Unknown	Unknown			1						1	Joint range of motion decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332249	11/12/2008	NJ				F	11/07/2008	I still feel soreness in my upper arm-it was bad the first week-not as bad now.									N	10/22/2008				OTH	PVT		Unknown	Unknown			1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332250	11/12/2008	NY	40.0	40		F	11/07/2008	Patient states she became short of breath, felt funny pre patient several 2-3 hours after receiving FLUZONE. No known allergies reported . Hypertension for which she takes DIVETIC and cerebrovascular accident in September 2001. cerebrovascular accident occurred during pregnancy, treated at Kingston City Hospital ER with BENADRYL and steroids. 3 times for racing heart per patient report. She vomited in the ER, phlegm per patient. Was sent home after several hours with diagnosis of allergic reaction. But ER doctor did not state a cause or discharge instructions, per patient. Patient stated she did speak to her physician after being seen and made her aware of ER visit and reaction. Will follow up with MD re: any further problems or distress. May contact vaccine compensation to inquire about monetary compensation if eligible.				Y					Y	10/17/2008	10/17/2008	0	Unknown patient. States she was drugged up and physician in ER diagnosed it as an allergic reaction. Cause unknown.	PUB	PVT		None	Hypertension; cerebrovascular accident; No known allergies			1						1	Dyspnoea; Feeling abnormal; Hypersensitivity; Palpitations; Vomiting	FLU3~SANOFI PASTEUR~U2832AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332960	11/12/2008	OR	48.0	48		F	11/10/2008	Arm very red swollen, painful. Tx heat pack, Benadryl and Darvocet, resolved over weekend.									Y	11/04/2008	11/04/2008	0	none	OTH	OTH	NONE	NONE	NONE			1						1	Erythema; Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89750~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0268915	11/13/2008		44.0			F	09/29/2008	This case was received via a search of the VAERS database on 17 January 2007, under reference number 168915. A 44-year-old female patient received TYPHIM VI, FLUZONE, and TWINRIX (GlaxoSmithKline); lot numbers, route, site and dates of administration were not provided. On an unreported date, the patient experienced encephalopathy, reactive arthritis, disorientation, memory impairment, headache, insomnia, and otitis media. It was noted that these events required intervention to prevent permanent impairment or damage, and resulted in disability.								Y	N					UNK	UNK					200800160	1						2	Arthritis reactive; Disorientation; Encephalopathy; Headache; Insomnia; Memory impairment; Otitis media	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~HEP A + HEP B (TWINRIX)~2|TYP~SANOFI PASTEUR~~UNK~UN~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~2	USA	Disabling	Influenza
0293054	11/13/2008		1.8			F	09/29/2008	Initial information received on 02 October 2007 from another manufacturer, report number WAES0708USA03829. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: Information has been received from a registered nurse concerning six patients who were vaccinated with VARIVAX (Merck). Subsequently, the patients experienced breakthrough chicken pox. A product quality complaint was not involved. Follow-up received 20-SEP-2007: Follow-up information has been received from a registered nurse concerning a 21-month-old female with no pertinent medical history or allergies who on 20-JAN-2007 was vaccinated in her left thigh with her first dose of PROQUAD (lot # 656165/1387F). It was unknown if there were any illnesses at the time of vaccination. On 20-JAN-2007 concomitant vaccines included fourth dose of TRIHIBIT (Sanofi Pasteur) (Lot # V1465AA & VE959AA), a fourth dose of PREVNAR (Wyeth) (Lot # B08684A) and first 0.25 mg dose of FLUZONE (Sanofi Pasteur) (Lot # UT2176JA). On 18-AUG-2007 the patient developed numerous lesions on her face. The patient was prescribed with ZOVIRAX 200 mg-5 mL three times a day for 5 days. The patient recovered from the adverse event at an unspecified date. The event was considered to be an other important medical event by the reporter. It was noted that the patient's sibling (WAES # 0709USA03345) experienced an adverse event. This is one of several reports from the same source. Additional information has been requested. TRIPEDIA lot numbers reported as V1465AA and VE959AA are not valid sanofi pasteur lot numbers.									Y	01/20/2007	08/18/2007	210		UNK	UNK					200703320	1						3	Familial risk factor; Skin lesion; Varicella; Skin lesion; Varicella; Varicella post vaccine	DTAPH~SANOFI PASTEUR~V1465AA~4~UN~UN~DTAP + HIB (TRIHIBIT)~2|FLU3~SANOFI PASTEUR~UT2176JA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|MMRV~MERCK & CO. INC.~1387F~1~UN~UN~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~2|PNC~PFIZER\WYETH~B08684A~4~UN~UN~PNEUMO (PREVNAR)~2|DTAP~SANOFI PASTEUR~V1465AA~4~UN~UN~DTAP (TRIPEDIA)~3|FLU3~SANOFI PASTEUR~UT2176JA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~3|HIBV~SANOFI PASTEUR~VE939AA~4~UN~UN~HIB (ACTHIB)~3|MMRV~MERCK & CO. INC.~1387F~1~UN~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~3|PNC~PFIZER\WYETH~B08684A~4~UN~UN~PNEUMO (PREVNAR)~3	USA		Influenza
0297171	11/13/2008	MO	76.0	76		F	01/08/2008	Initial report received on GS November 2007 from a health care professional. A 76-year-old female patient, with no illness at the time of vaccination, had received a first dose, left deltoid, intramuscular injection of FLUZONE SV 2007-2008, lot number U2442AA  on 01 November 2007. The following day, the patient experienced sweating and thought she may have run a fever (temperature not taken). She also developed a large walnut sited lump under her left jaw and a smaller one under her right jaw. The lumps were not sore, and the patient did not have a sore throat. The event required a doctor visit. Per the reporter, the lumps had almost resolved. Follow-up information was received from the health professional on 07 January 2008. The patient still reported occasional swelling of lymph nodes in her neck, and occasional night sweats. Treatment included one aspirin daily. At the time of the report, she had not yet been seen by her physician.									N	11/01/2007	11/02/2007	1		PUB	OTH	ASA		The patient had no illness at the time of vaccination and no medical history. Other medication included aspirin.		200703741	1						2	Lymphadenopathy; Night sweats	FLU3~SANOFI PASTEUR~U2442A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0298981	11/13/2008	OH	61.0	61		F	08/08/2008	Initial report received on 06 December 2007 from a health care professional.  A 63 year-old female patient, with no concurrent illnesses, but who had past medical history of high cholesterol, and hyperthyroidism, had received a 17th, intramuscular, right deltoid full dose of FLUZONE SV 2007-2008 (lot number U2523AA) on 02 November 2007.  On 02 November 2007 the patient was receiving the FLUZONE vaccination in the left deltoid, and just after the needle was injected and the syringe was being pushed, FLUZONE squirted out of the syringe all over the patient and the vaccine administrator.  The needle and syringe were withdrawn, and another syringe was used to administer FLUZONE in the right deltoid.  On 04 December 2007, the patient reported she had soreness in the area where she was vaccinated for two days, then seven days later (approximately 09 November 2007), developed muscle weakness and muscle aches in both arms from the shoulder to the elbow (with no joint involvement).  The muscle weakness and aches lasted until 03 December 2007 when the patient was evaluated by her physician.  At that time, she was prescribed NAPROXEN as treatment of the symptoms.  No relevant diagnostic tests or laboratory data were performed.  At the time of this report, the patient had not recovered, but her symptoms were better.  A corrective version was created with the same latest received date as the previous version (06 December 2007) for the sole purpose of amending the initial received date from 04 December 2007 to 06 December 2007 in the narrative above as the initial receipt date of this case was 06 December 2007 not 04 December 2007.  No other medically significant information was received or added to this case.  Follow up information was received on 07 August 2008 from a health care professional.  No additional information was reported at this time.				Y					N	11/02/2007	11/02/2007	0	None	OTH	OTH	LIPATOR, SYNTHROID		The patient had no illnesses at the time of the vaccination on 02 November 2007; however, the patient had history of high cholesterol and low thyroid.  The patient had not received any other vaccinations within four weeks of 02/NOV/2007.		200704189	1						2	Device leakage; Injection site pain; Muscular weakness; Myalgia	FLU3~SANOFI PASTEUR~U2523A~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0299581	11/13/2008	NV	63.0	63		M	08/08/2008	Initial report received on 13 December 2007 from a nurse. A 63 year-old male patient, with no concurrent illnesses, and a past medical history of coronary artery disease, hypertension, and arthritis, had received a sixth, intramuscular left deltoid dose of FLUZONE  (lot number U2525AA) on 11 December 2007 at 17:00 p.m. Early the next morning on 12 December 2007, at around 01:00 a.m., approximately eight hours post vaccination, the patient experienced weakness, fever and chills, and his arms felt heavy. He sleepy for several hours, and his wife took his blood pressure and discovered his blood pressure was 150/132. The patient returned to the clinics where his blood pressure reading was 146/88, and at that time, he was feeling better. Treatments received and diagnostic test's performed were not provided. At the time of this report, the patient had recovered. Follow up information was received on 07 August 2008 from a nurse. The patient's final diagnosis was hypertension and possible vaccine reaction. Blood pressure were not checked prior to the vaccination. The patient has recovered from the events.				Y					Y	12/11/2007	12/12/2007	1	No labs reported	OTH	PVT	Aspirin; Caduet; Celebrex; Lasix; Lisinopril; KCL; Toprol XL; Ocuvite		December 2007; but had a history of CAD, arthritis, and hypertension. She had no known drug allergies.		200704278	1						2	Asthenia; Chills; Condition aggravated; Hypertension; Pyrexia; Sensation of heaviness	FLU3~SANOFI PASTEUR~U2525A~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0321413	11/13/2008		59.0	59		F	09/29/2008	This serious case was received from a health care professional on 25 July 2008. A 59-year-old female patient had received an injection (route/site and lot number not reported) of FLUZONE SV 2007-2008, and on the day of vaccination, she complained of pain in her shoulder that persisted for approximately four months. She was diagnosed approximately four months later with a torn rotator cuff which she had surgically corrected. Past medical history included osteoarthritis and menopausal symptoms. No further information was provided.									U	10/23/2007	10/23/2007	0		UNK	UNK			The patient had not been ill at the time of vaccination and had a past history of hyperlipidemia, menopausal symptoms, dizziness, ? osteoarthritis and breast cancer.		200802440	1						2	Musculoskeletal pain; Rotator cuff syndrome; Shoulder operation; Musculoskeletal pain; Rotator cuff syndrome; Surgery	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0332150	11/13/2008	CA	65.0	65		F	11/03/2008	Vac. given 10/30/08 @ 9:35 am.  At 11:30 am: gastric tightness (knot), persistent nausea; extremely swollen, red eyes; persistent feeling of fainting/passing out (hypotension), hoarseness, tightness in lungs and shallow, limited breathing; at 2-2:30 pm, transient pain over both kidney areas.  Saw MD at 4:45 pm in clinic.  Transferred to ER to R/O heart attack; BP continued @ 80's/40's for several more hours.  Discharged 10/31/08 at 1 am with no evidence of heart attack, with low-normal BP.  Swollen eyes resolved after several days.				Y					Y	10/30/2008	10/30/2008	0	sl. elevated WBC	UNK	UNK	Singulair, Estradiol, Prometrium, thyroid	none	asthma (mold, cats, house dust, grasses, junipers, air pollution); penicillin, septra. GERD.			1						1	Chest discomfort; Dizziness; Dysphonia; Eye swelling; Hypotension; Hypoventilation; Loss of consciousness; Nausea; Ocular hyperaemia; Renal pain; White blood cell count increased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA349BB~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0332212	11/13/2008	NJ				F	11/07/2008	I had a lot of soreness a few days after the shot; the soreness has never gone away and seems to be worse the last few days. It is painful when I raise my arm. I have not sought any medical attention yet.									N	10/22/2008				OTH	PVT		Unknown	Unknown			1						1	Pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332214	11/13/2008	NJ				F	11/01/2008	My arm still hurts; it varies from day to day whether I can even lift it up or not. I haven't gone to the doctor for it.										10/22/2008				OTH	PVT		Unknown	Unknown			1						1	Hypokinesia; Pain in extremity	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332215	11/13/2008	NJ				F	11/07/2008	On the Monday after the shot: Joints were sore, more than the normal; I had a doctor's appointment on Sat, sinus infection also.									U	10/22/2008				OTH	PVT		Unknown	Unknown			1						1	Arthralgia; Sinusitis	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332216	11/13/2008	NJ				F	11/07/2008	I am one of those who are still uncomfortable and hurting. I have not said anything because I thought that maybe this was normal but then I received an Email yesterday and said oh okay, everyone is experiencing this. My complaints are; I cannot raise my left arm without being in pain and when I wake up in the morning, I cannot move my arm at all for a little while. In fact, I take my other hand and raise my left arm with it to move it around. After a little while I can  move my arm but it still hurts. Even right now at my desk I tried to lift my arm and cannot lift it after a certain point, just wont go, it hurts a lot. I have not seen a doctor since. I really don't have time and especially money to pay for the co payment, and I hope it will go away. Keep me posted as to what to do next. It is really annoying. I have two small children and it is hard to carry them.										10/22/2008				OTH	PVT		Unknown	Unknown			1						1	Discomfort; Hypokinesia; Injected limb mobility decreased; Pain	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332230	11/13/2008	NJ				F	11/07/2008	I, too, had discomfort after the shot but I didn't think to tell anyone about it because I though I was the only one. My arm was quite sore and hot at the injection site and it hurt a lotto raise my arm. That lasted for about 4 or 5 days but I did not go to the Dr. about it cause I thought  it would go away by itself, which it did and now it is fine.										10/22/2008				OTH	PVT		Unknown	Unknown			1						1	Discomfort; Injected limb mobility decreased; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332237	11/13/2008	NJ				F	11/07/2008	Regarding FLUZONE, I had never had one before so I was not aware that there was anything unusual about the after affects. I did feel somewhat like after a tetanus shot-sore at the site of the injection, muscles sore-unable to lift arm above shoulder level, and tired and achy all over. That went away after four days, but then came back a day later for three more days. Now I just have some muscle soreness left.										10/22/2008				OTH	PVT		unknown	unknown			1						1	Fatigue; Hypokinesia; Injection site pain; Myalgia; Pain	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332242	11/13/2008	NJ				F	11/07/2008	I did not complain about the flu shot, but I'm still having pains in my elbows joints, do u know how long it will take.....I keep soaking with warm water & rubbing the area.									N	10/22/2008				OTH	PVT		Unknown	Unknown			1						1	Arthralgia	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332244	11/13/2008	NJ				M	11/07/2008	I did not seek medical attention for this, however my shoulder hurt for days afterwards. I took aspirin, Tylenol, etc., put ice packs on it, and put icy hot cream on it too. In fact it still hurt a bit about 5 days later.										10/22/2008				OTH	PVT		Unknown	Unknown			1						1	Musculoskeletal pain	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332247	11/13/2008	NJ				F	11/07/2008	My arm is still very painful and I have the difficulty to wear the bra in the morning. Put the T shirt on or off. I need use of my right hand to help a lot for the jobs which used to be handle by the left hand. Any actions related to use left upper arm muscle (which is so stiff now) will give me a hard time and I cannot bend my left arm to my back which I used to do it easily. But I think I get better. I did not see any doc yet and also did not take any medicine as of now.										10/22/2008				OTH	PVT		unknown	unknown			1						1	Activities of daily living impaired; Injected limb mobility decreased; Musculoskeletal stiffness; Pain in extremity	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332253	11/13/2008	MN	41.0	41		F	10/31/2008	Patient feels injection given too high on the arm and arm/shoulder all stiff and sore.  Reports decreased ROM 1 wk after shot given.  Patient returned to clinic 11/8/08 with continued stiffness in shoulder and decreased ROM.									U	10/15/2008	10/29/2008	14	None to date	PVT	PVT		No	Penicillin and Erythromycin Allergy			1						1	Injection site pain; Joint range of motion decreased; Musculoskeletal stiffness; Pain in extremity	FLU3~SANOFI PASTEUR~U2807AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332254	11/13/2008	MA	58.0	58		F	11/11/2008	Received flu shot on Oct. 30, 2008 - got bad head-ache on Nov.1, 2008 -experienced sudden and violent vomiting. Headache and body aches for 5 more days.									Y	10/30/2008	11/01/2008	2		PUB	OTH	None	None	None			1						1	Headache; Pain; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332255	11/13/2008	WI				F	11/07/2008	pt reports (R) arm swelling. Advised to take BENADRYL 50 mg TID and TYLENOL for pain 11-10-08 called pt swelling is gone on (R) arm feeling fine									Y	11/06/2008	11/07/2008	1		PVT	UNK			ZYBAN; Cephalexin			1						1	Injection site swelling	FLU3~SANOFI PASTEUR~U2749AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1384U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332261	11/13/2008	AL	4.0	4		F	11/13/2008	Left thigh, 6 by 6 cm, red swollen area at site of injection. Warm to touch and itches. Started this morning at 7:30.									Y	11/11/2008	11/13/2008	2		PVT	PUB						1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Injection site warmth	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B103AC~5~UN~LL~DTAP + IPV (KINRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500558P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~MERCK & CO. INC.~02854~2~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0523X~2~UN~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0332262	11/13/2008	NC	53.0	53		M	11/12/2008	Patient describes sharp pains at vaccine admin site - has persisted for approx 2 wks.									U	10/31/2008	10/31/2008	0		OTH	PVT		None	None			1						1	Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89738~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332263	11/13/2008	AZ	43.0	43		F	11/11/2008	Patient c/o pain (throbbing) at injection site.  Turned pale, felt faint, tingling down left arm, developed nausea, BP checked 60/40 around 3:10pm.  Patient placed supine position, at 3:20pm BP 100/60 - 78.  Paramedics arrived PO 99%.  Informed us of history MVP (patient).  Patient ran this AM, drank approximately 2 glasses water and large cup coffee before coming to clinic for injection.  She received one cup water, after BP started to rise at 3:20pm.				Y					Y	11/11/2008	11/11/2008	0	None	PVT	PVT	None	None	MVP Mitral Value Prolapse			1						1	Dizziness; Hypotension; Injection site pain; Nausea; Pallor; Paraesthesia	FLU3~SANOFI PASTEUR~U2809AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332264	11/13/2008	CA	11.0	11		F	11/12/2008	1 day Right upper arm with redness, warmth, swelling, and firmness-measured 16 1/2 cm x 14cm diameters and low grade fever 100.2 F measured at home x 1 day.									U	11/11/2008	11/12/2008	1		PVT	OTH	none	none	asthma			1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88636~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HPV4~MERCK & CO. INC.~0652X~1~IM~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2571AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0332265	11/13/2008	IL	53.0	53		F	11/12/2008	11/12/2008 Pt. reports very swollen, red and tender arm at injection site. Pt went to ER on 10/30/2008 and was give Phenergan Solu-Cortef and Zantac- also c/o dizzines and metal taste in mouth.				Y						10/29/2008	10/30/2008	1	none processed	PVT	PVT		none	Depression, asthma, GERD, COPD			1						1	Dizziness; Dysgeusia; Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~62751AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1021X~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332266	11/13/2008	PA	1.22	1	.2	F	11/13/2008	Patient had febrile seizure and seen in ER also had 2 days of fever, vomiting, diarrhea. Vomitting started 1/22/09 at 8am and stopped at 6pm then at 9:40pm c/o knees killing me				Y					Y	10/24/2008	10/24/2008	0	None	PVT	UNK		none	febrile seizures, asthma			1						1	Arthralgia; Diarrhoea; Febrile convulsion; Vomiting	DTAP~SANOFI PASTEUR~02952AA~4~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2788HA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332267	11/13/2008	MD	7.0	7		M	11/07/2008	Pt with no previous history of needing ALBUTEROL.  Mother thinks he may have wheezed in past with URI'S.  Started wheezing night of FLUMIST and req'd ALBUTEROL and ORAPRED x5d.				Y					Y	11/03/2008	11/03/2008	0		OTH	PVT						1						1	Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0332268	11/13/2008	NY	35.0	35		M	11/04/2008	Vaccination site - No Rx. Itching right leg (6-8cm reddened). 2 days later progressed to clear liquid vesicles. Day 4 increased in size, day 6 color changed to clear yellow blisters broke, painless. Edema- ankle, knee, upper calf. Day 4 cultures negative.				Y					Y	10/17/2008	10/19/2008	2	Reddened systemic Rx full body; ER 11/7; BC Neg; Steroids prescribed; Biopsy day 9 negative.	PUB	PVT	None	None	None			1						1	Biopsy site unspecified normal; Blister; Culture negative; Oedema; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA358AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0332269	11/13/2008	CA	35.0	35		M	11/13/2008	Weakness, SOB, unable to walk, raise arms, lift himself from bed. Slurred speech. Diag: GBS. CK 852. 11/19/08-ED record received for DOS 11/1/08-presented with C/O shortness of breath and anxious. Received flu shot on 10/18/08 and subsequently developed weakness. In the midst of a workup for Guillain-Barre syndrome. Had a lumbar puncture and was in process of having MRI when developed shortness of breath. Quinton catheter inserted. Intermittently short of breath for 4 days. Anxious affect. 1/6/09-records received for DOS 10/31-11/21/08-DC DX: Guillaine-Barre syndrome. Macrocytosis.  Received two course of plasmapheresis. Elevation of muscle enzymes. Low MCV. Generalized weakness and inability to move upper or lower extremities and difficulty breathing.  1/23/09-neurology consult 12/9/08 received-presented in October with severe weakness in legs, arms, almosty difficulty with breathing. Received plasmapheresis and IVIG.  Question of possible deterioration though much more improved at this time. Continues to C/O shortness of breath. 2/2/09-neurology consult for DOS 11/1/08-C/O increasing weakness somewhat dizzy sometightness when breathing. PE: no edema  not much muscle tenerness. Weakness in upper extremities, grip is weak, legs are much weaker and cannot life them off bed. No knee or ankle reflexes. Normal downgoing toes. Sensation is presentation no definite sensory level. Impression:generalized weakness progressively worsening. Rhabdomyolysis. Viral syndrome.					Y	21			Y	10/18/2008	10/20/2008	2	PT; PTT; Hgb; Hct; CBC; IgG; IgM 11/19/08-records received-Electrocardiogram non-specific changes in 3 and AVF and J-point elevation. Lumbar puncture. MRI 1/6/09-records received-CSF protein 96, monocyctes 88.	PVT	PVT		none	1/23/09-records received-PMH: Hepatitis B positive. TB.  2/2/09-previous smoker.			1						1	Abasia; Activated partial thromboplastin time; Asthenia; Blood creatine phosphokinase increased; Blood immunoglobulin G; Blood immunoglobulin M; Dysarthria; Dyspnoea; Full blood count; Guillain-Barre syndrome; Haematocrit; Haemoglobin; Mobility decreased; Prothrombin time	FLU3~CSL LIMITED~02749111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Hospitalisation	Influenza
0332270	11/13/2008	CA	21.0	21		U		Light headedness; Tingling fingers; Warm and sweaty; Left hand blotchy									Y	11/12/2008	11/12/2008	0		OTH	PUB	None	None	None			1						1	Dizziness; Hyperhidrosis; Paraesthesia; Rash macular; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89969~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332277	11/13/2008	MA	27.0	27		F	11/13/2008	This case was reported by a influenza vaccine distributor and described the occurrence of throat closing up in a 27-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included latex allergy. On 3 November 2003, the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). On 3 November 2008, 4 hours after vaccination with FLULAVAL, the subject experienced throat closing up and trouble breathing. The subject was treated with adrenal (pen). The subject experienced a reaction, clarified as, her throat was closing up and she was having trouble breathing approximately four hours after receiving FLULAVAL. The subject gave herself an injection with Epi Pen and went to the emergency room. The emergency room physician and her primary care physician attributed the reaction to a cross reaction to the thimerosal preservative in the FLULAVAL and her latex allergy. In November 2008, the events were resolved.				Y				Y	Y	11/03/2008	11/03/2008	0	UNK	OTH	PVT		Latex allergy	Concomitant medications were unknown.  The subject had previously received influenza vaccinations and no adverse events were reported.  The subject stated in her consent form that she had never had serious reactions following any previous vaccines.		A0756082A	1						1	Dyspnoea; Reaction to preservatives; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA176AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Disabling	Influenza
0332279	11/13/2008	MO	10.0	10		M	11/13/2008	Red warm area (L) upper arm-tender. Duricef 500/5 1 tsp Bid x 10 days.				Y					Y	11/04/2008	11/05/2008	1		PVT	PVT	Singulair	No	mild asthma			1						1	Erythema; Skin warm; Tenderness	FLU3~SANOFI PASTEUR~U2798FA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB309AA~1~IM~LA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1014X~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0332282	11/13/2008	IL	47.0	47		M	11/13/2008	Headache for 4 days, chills, fatigue.									N	11/10/2008	11/10/2008	0		PVT	OTH			None			1						1	Fatigue; Feeling cold; Headache	FLU3~SANOFI PASTEUR~U2756AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332283	11/13/2008	TX	20.0	20		F	11/13/2008	In right shoulder didn't start aching till 7:00 last night. Woke up at around 8:30 am shivering, but I wasn't cold. Had a fever of 101.9. Couldn't barely get up or even shower legs were numbed, shoulder barely move it.									N	11/12/2008	11/12/2008	0		OTH	OTH		Common minor cold	anemia			1						1	Chills; Hypoaesthesia; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89880~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~09894~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332284	11/13/2008	NC	3.0	3		M	11/13/2008	Dx with Bell's palsy on 11-12-08.  Symptoms started 11-10-08 with facial drawing and left eye will not close completely.  Left side of face will not move when he smiles, tongue deviates to right side, taste buds more prominent on anterior part of the tongue. records received 11/18/08-for DOS 11/12/08-presented with C/O 2 day face drawing, right side of face drawing when smiling or cries. Left eye will not close all the way also watering a lot.  Assessment:Bell's palsy.				Y					U	10/20/2008	11/10/2008	21		UNK	UNK	none	none	11/18/08-records-PMH: bronchiolitis at age 6 months. Bilateral myringotomy and tube 1/07.			1						1	Facial palsy	FLUN3~MEDIMMUNE VACCINES, INC.~500548P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0332286	11/13/2008	OK	29.0	29		F	11/13/2008	rash, palms of hands and feet itching and hurting, eyes swollen									Y	11/06/2008	11/07/2008	1	none	PUB	PUB	none	cough	none			1						1	Eye swelling; Pain; Pruritus; Rash	FLU3~SANOFI PASTEUR~U2772AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332287	11/13/2008	MI	4.0	4		M	11/13/2008	Child seen on 11/04/08 for PE/Imms @ Clinic.  Due to time constraints, Pt and family sent to Imm Clinic for vaccinations.  6 vaccines given (DTaP, Hep A, MMR, Var, TIV flu, IPV) divided btwn. bilat. thighs without incident.  Parent called Well child clinic on 11/7/08 seeking advise re: pain in legs child won't walk.  Parent instructed to use ACTM for pain control and call on 11/10/2008 if child still with symptoms.  Parent called on 11/10/08 seeking advise for leg pain again.  Parent instructed to continue using ACTM and seek care with child at MD office.  Child seen on 11/11/08 @ MD office with continued sx. Per parent, was told nl. S.E. of vaccines.  To cont. with pain control efforts and encourage walking, to return to clinic in 1 wk. if no better.  Parent reported no fever, no reddness/swelling @ sites noted after date of vaccination. Pain worse in front of R leg, child won't run or jump, just walks slowly.				Y					U	11/04/2008	11/07/2008	3		UNK	UNK	unknown	no	none			1						1	Abasia; Gait disturbance; Injected limb mobility decreased; Injection site oedema	DTAP~SANOFI PASTEUR~C2957AA~5~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2829AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB247AA~2~IM~RL~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~A0492~5~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0908X~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1014X~2~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0332288	11/13/2008	AL	12.0	12		M	11/13/2008	Left-sided facial weakness starting within 1 week after influenza vaccine administered (left arm).  12/15/2008 MR received from PCP for DOS 10/31/08. Pt seen by PCP for c/o sore throat/ body aches/ runny nose. DX: URI.  Flu shot given. Seen again 11/12/08 with L sided facial weakness x 1 week.  Dx:  Bell's Palsy.				Y					Y	10/31/2008	11/06/2008	6	None	UNK	UNK	albuterol inhaler PRN	viral URI/sore throat without fever	asthma. PMH: none noted			1						1	Facial paresis	FLU3~SANOFI PASTEUR~u2759aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332291	11/13/2008	MD	37.0	37		F	11/13/2008	nausea, low-grade fever, muscle pains, stiffness, soreness, general malaise, dizziness, coughing				Y					Y	11/12/2008	11/12/2008	0		UNK	UNK	None	None	None			1						1	Cough; Dizziness; Malaise; Musculoskeletal stiffness; Myalgia; Nausea; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~U2750AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332292	11/13/2008	WI	6.0	6		F	11/13/2008	Burnign of nose and eyes immediately post Flumist administration and lasting 5 days after				Y					U	11/07/2008	11/07/2008	0		PVT	PVT						1						1	Eye burns; Nasal discomfort	FLUN3~MEDIMMUNE VACCINES, INC.~50569p~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0332294	11/13/2008	NY	51.0	51		F	11/13/2008	Had very minor rash occur with itching on right side of face, neck and hands and itching of tongue that started about an hour after the vaccine was administered. Employee advised to call her Dr. and was told to take allergy medication that she carries on her. Took 2 60mg generic Allegra and symptoms dissipated within an hour. Employee also followed up with her primary care physician to discuss.									Y	10/16/2008	10/16/2008	0		UNK	PVT	declined to provide them		hypertension, obesity, allergic to penicillin and sulfa drugs, taken from employee's medical file from a 2003 physical exam			1						1	Paraesthesia oral; Pruritus; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8811002~6~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332295	11/13/2008	GA	37.0	37		F	11/13/2008	Headache, Malaisa, Fever, Sinus congestion for several weeks ongoing, dizziness, cough, vision distorted, rash to trunk and lower ext.				Y					N	10/07/2008	10/08/2008	1		PVT	PVT	None	None	No			1						1	Cough; Dizziness; Headache; Malaise; Pyrexia; Rash; Sinus congestion; Visual impairment	FLU3~CSL LIMITED~02749111a~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0332296	11/13/2008	GA	24.0	24		F	11/13/2008	APPROXIMATELY 3 HOURS AFTER RECEIVING HER FLU VACCINE, PATIENT STARTED TO COMPLAIN OF THE FOLLOWING SYPTOMS: EYE REDNESS WITH SWELLING AND ITCHING, THROAT SCRATCHY, HAD URGE TO CONSTANTLY CLEAR THROAT AND BEGIN TO FEEL LIKE IT WAS SWELLING.  SHE NOTIFIED NURSING SUPERVISOR AND BEGAN TO FEEL LIKE HER THROAT WAS CLOSING AND WAS SENT TO THE ER.				Y					Y	11/07/2008	11/07/2008	0		UNK	UNK		NONE	NO			1						1	Eye pruritus; Eye swelling; Ocular hyperaemia; Pharyngeal oedema; Throat irritation	FLU3~CSL LIMITED~01849111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0332298	11/13/2008	OH	42.0	42		F	11/13/2008	Patient complanis of left wrist/lower arm pain since receiving the flu vaccine on 11-10-08. Swelling noted, no c/o fevers.  Has received the flu vaccine for 5 years and has never had a reaction like this before.  On exam, pt had slight ecchymosis/swelling at site. Lower arm mildly swelled/tender laterally.  Wrist tender throughout, mildly swollen and no redness.  Was treated with Naproxen 500mg. 1 p.o. BID w/food.									Y	11/10/2008	11/10/2008	0	none	UNK	UNK	unknown	none	none			1						1	Arthralgia; Injection site haemorrhage; Injection site swelling; No reaction on previous exposure to drug; Oedema peripheral; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~89979~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332299	11/13/2008	WA	23.0	23		F	11/13/2008	Several hours after receiving the vaccine  Pneumovax the patient visited an Emergency room. She experienced severe symptoms on the right side of her body: Swelling, numbness, difficulty moving. She also recived flu vaccine from another provider on the same day. The swelling on her arm was located by the site of of Pneumococcal injection.				Y					Y	11/10/2008	11/11/2008	1		UNK	PVT		None	None were listed on the consent form			1						1	Hypoaesthesia; Injection site swelling; Joint range of motion decreased; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~?????????~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1382U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332301	11/13/2008	NC	18.0	18		M	11/13/2008	Right arm began swelling at site of injection 11-02-08 2 days after injection. On 11-03-08 right arm swollen, red and warm to touch with area beginning at injection site ending at the elbow in large oval area.									Y	10/31/2008	11/01/2008	1		PUB	PUB						1						1	Erythema; Injection site swelling; Injection site warmth; Oedema peripheral	FLU3~SANOFI PASTEUR~U2790AA~7+~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0432X~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0332303	11/13/2008	SC	43.0	43		F	11/13/2008	States after receiving flu vaccine getting ready for bed and felt extremely cold--could not get warm--layered clothing.  Unable to get to sleep right away.  Finally fell asleep, but awoke at 3AM soacked and sweating.  Came to work 11/4--felt wiped out.  By PM on 11/4 felt better.  No meds.									Y	11/03/2008	11/03/2008	0	N/A	PUB	PUB	low dose BP med	none	none		SC 0822	1						1	Fatigue; Feeling cold; Night sweats; Sleep disorder	FLU3~SANOFI PASTEUR~U2828AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332305	11/13/2008	IL	66.0	66		M	11/13/2008	Within two hours my eyes felt tired and burning. I started feeling very tired, weak, aching and wheezing. Within 4 hrs. I took a nap and woke up in 3 hrs.,shivering badly. Late in evening my body and head became very warm. I believe I was running a temperature. The next day 11:00 am., I feltr much better,but, weak and my eyes were swollen.									N	11/12/2008	11/12/2008	0	Dna.	UNK	PUB	None	DNA	None	DNA.~ ()~NULL~~In Patient|UNK.~ ()~NULL~~In Sibling1		1						1	Asthenia; Asthenopia; Chills; Eye burns; Eye swelling; Fatigue; Feeling hot; Pain; Pyrexia; Wheezing	FLUX~UNKNOWN MANUFACTURER~UNK.~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332306	11/13/2008	MT	22.0	22		M	11/13/2008	Patient developed fever and hallucinations one hour after receiving vaccination and symptoms lasted for about 3 hours.  Patient did not seek any treatment.									Y	11/05/2008	11/05/2008	0	None	PUB	UNK	Synthroid 0.088 mg daily, Captopril 12.5 mg tid, Thiola 100 mg bid, Urocit 10 mEq tid	None	Hypertension, hypothyroidism, recurrent kidney stones			1						1	Hallucination; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA173AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332307	11/13/2008	TX	57.0	57		F	11/13/2008	Very bad headache, swollen throat and neck, inflamed sinus cavity, puffy eye lids, very red eyes and a discharge, matted eyelashes this morning, eyes sensitive to bright light, need to lay down and sleep.  Felt bad for about 2 days.									Y	11/04/2008	11/04/2008	0		UNK	UNK	none	none	none			1						1	Eye discharge; Eyelid oedema; Feeling abnormal; Headache; Local swelling; Ocular hyperaemia; Pharyngeal oedema; Photophobia; Sinus headache	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332308	11/13/2008	OR	10.0	10		F	11/13/2008	Status epilepticus, received fosphenytoin.  11/18/08 Reviewed hospital medical records of 11/10/2008. FINAL DX: new onset seizure; status epilepticus Records reveal patient experienced staring & unresponsiveness while on playground at school.  Had recent cold s/s.  Generalized tonic clonic seizure activity when EMS arrived & continued for approx 10 min.  IV meds stopped seizure but continued to have mouth chewing, unresponsive to verbal stimulation, vomited x 1, postictal in ER.  Neuro consult done.  Admitted overnight for observation.  No further seizure activity & d/c to home on diastat only.				Y	Y	1			Y	11/06/2008	11/10/2008	4	MRI-normal, EEG-normal  LABS: CT scan WNL. CBC & chemistry WNL.	UNK	UNK	None	None	None  PMH: allergies, pneumonia as infant.			1						1	Electroencephalogram normal; Nuclear magnetic resonance imaging normal; Status epilepticus	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0332309	11/13/2008	GA	5.0	5		F	11/13/2008	Swelling at site of immunization				Y					Y	11/12/2008	11/12/2008	0		PVT	PVT	Pulmicort, Albuterol, Robitussin		Asthma			1						1	Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89970~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0332311	11/13/2008	NJ				F	11/13/2008	Pain in shoulder Dr said has brusitis as a reaction to receiveing the shot high near the shoulder				Y						10/24/2008				UNK	PVT						1						1	Bursitis; Musculoskeletal pain; Vaccination complication	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332312	11/13/2008	NC	45.0	45		F	11/10/2008	PT REPORTS ABOUT 1 1/2 HRS POST INJECTION HAVING DIFFICULTY BREATHING, COUGHING, CHILLS, AND FEVER (100.2). WENT TO ER AT HOSPITAL. WAITED 2 HRS TO BE SEEN. PT TOOK OWN TYLENOL THAT SHE BROUGHT WITH HER AND LEFT ER PRIOR TO BEING SEEN BY MD. PT STATES SHE FELT BETTER AFTER TYLENOL.				Y					Y	11/05/2008	11/05/2008	0	NONE	UNK	UNK	NONE					1						1	Chills; Cough; Dyspnoea; Pyrexia	FLU3~SANOFI PASTEUR~U2807AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332314	11/13/2008	ND	72.0	72		F	11/13/2008	Pt. stated arm was sore and itchy on Sat. Used Benadryl & ice. On Mon., Oct. 6th was seen by Nurse Practitioner at local clinic who measured site where Zostavax administered (Back of arm) 15-17 cm., area was red without blistering. No drainage noted. Keflex 500 mg ordered TID. (Shingles vaccine were public funds, Influenza was private funds)				Y					U	10/02/2008	10/04/2008	2		PUB	PUB		None				1						1	Erythema; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88637~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARZOS~MERCK & CO. INC.~0557X~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0332315	11/13/2008	MA	18.0	18		F	11/13/2008	Vomiting, Dizziness, Neck and Ear discomfort									Y	11/11/2008	11/12/2008	1		PUB	PVT		no	no			1						1	Dizziness; Ear discomfort; Musculoskeletal discomfort; Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332316	11/13/2008	MA	24.0			F	11/13/2008	Diagnosed 5 years ago with severe allergy to flu vaccine (anyphylaxis & intubated x 4 hours)has avoided since. 11/11/08 22 Co-workers received Fluzone vaccine in small, not well ventillated room, syringes were prepped in another area so minimal aerosolization occured. 20 minutes later she walked into this room and developed top lip numbness and stuffy nose, went for quick walk out of area, returned to same room & developed chest tightness and wheeze.  50mg Benadry po without relief, brought to ED.  Treated with steroids po and IV, Resp. treatments O2 sats 84%.  Improved for a while then decompensated, tach 180's.  Gastric Bypass 2 months ago with PICC line, did Chest CT with contrast to r/o PE, which was negative. Hospitalized x 48 hours, sent home on po steroids, Benadryl, Zyrtec, Albuterol inhaler.  Has epi-pen and has been educated to avoid handling of flu vaccinations, IM and nasal. 12/15/08-records received 11/118/08-presented to ED with indirect exposure to influezna vaccince which caused intense allergic reaction and after steroids became tachycardic and short of breath. Admitted for observation.				Y	Y	1			Y		11/11/2008		Unclear if serolgies were obtain, Chest CT with contrast to r/o pulmonary embolus was negative.Pulse Oximetry on mask O2 was 84%/per patient.	UNK	UNK	Topamax & Imitrex for migrains, MVI's, Calcium.	DENIES	TAPE, LISINIPRIL (N/V WITH HIGH DOSE MED), FLU VACCINATION; MIGRAINE HEADACHES, MILD ASTHMA; GASTRIC BYPASS 2 MONTHS AGO.	ANAPHYLAXIS~Influenza (Seasonal) (Flu-Imune)~~20.00~In Patient		1						1	Chest discomfort; Computerised tomogram normal; Hypoaesthesia oral; Nasal congestion; Oxygen saturation decreased; Tachycardia; Wheezing	FLU3~SANOFI PASTEUR~U2791FA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0332317	11/13/2008	NC	55.0	55		F	11/13/2008	On November 6, 2008 at approximately 11:40 a.m. nurses gave me a flu shot at my place of work.  In approximately five minutes I felt my throat tightening and I became hoarse.  The nurse then drove me over to facility for treatment.  By the time I go to the facility I was wheezing, coughing and choking.  Initial treatment involved administering epinephrine.  I also used my albuterol inhaler.  After the epinephrine wore off I had another attack of wheezing, coughing and choking.  At that time I was given a shot of benadryl.  A subsequent shot of a steroid was given.  At approximately 6:00 p.m. eastern that evening I had another slight attack that was treated with benadryl and my albuterol inhaler.  At one calendar week later (11/13) I still am hoarse and am taking benadryl orally daily.  Additional symptoms include flu like aches, tiredness and an activation of the eczema in my left ear.				Y					Y	11/06/2008	11/06/2008	0	Diagnosis was allergic reaction to flu shot.  I am not allergic to chicken, eggs, feathers or mercury but am allergic to neomycin.  The conclusion was that the flu vaccine was in a container with neomycin which caused my reaction.	UNK	UNK		None	Also allergic to dairy products.	None~ ()~~0.00~In Patient		1						1	Choking; Cough; Dysphonia; Eczema; Fatigue; Hypersensitivity; Influenza like illness; Pain; Throat tightness; Wheezing; Condition aggravated; Cough; Dysphagia; Sinus operation; Throat tightness; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89126~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0332318	11/13/2008	CO	65.0	65		M	11/13/2008	Pt call on the Nov 13 complaining of severe muscle aches in the neck, back and shoulders with a pain of 7 out of 10. His symptoms began 6 days post administration. And 9 days after the shot pt develpoed a rash on the right side of his chest									U	11/03/2008	11/09/2008	6	On the 12th of Nov 2008 pt went to Dr and had a CPK performed	UNK	PUB	Zetia, ASA, Crestor, Niacin	None	Heart diesease			1						1	Back pain; Musculoskeletal pain; Myalgia; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89982~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332320	11/13/2008	CA	44.0	44		M	11/13/2008	Vaccine administered 10/05/2008. Symptoms started on 10/09/2008 with PERSISTENT NAUSEA, VOMITING AND DIZZINESS. Chlorpheniramine has reduced part of the symptoms, but the vertigo still persists, Diazepam was also prescribed.  NOTE: I am the injured-person's PCP completing this report. Patient is a pharmacist: if you need the lot number, please contact him at his place of work.									N	10/05/2008	10/09/2008	4	none	UNK	UNK		none	allergery to codeine, aspirin			1						1	Dizziness; Nausea; Vertigo; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~OOOOOOO~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0332321	11/13/2008	NY	45.0	46		F	11/13/2008	Swelling of throut and tongue beginning about 3 hrs after injection, followed by full flu symptoms lasting till early next morning. Linguring effects continuing. No treatment sought, after doctor hours or I would have gone to my doctor.									Y	11/11/2008	11/11/2008	0	None sought	UNK	UNK		No illness prior to vaccination	None			1						1	Influenza; Pharyngeal oedema; Swollen tongue	FLU3~SANOFI PASTEUR~U2750AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332324	11/13/2008	IL	67.0	67		F	11/13/2008	Redness and itching around the injection site of right arm same evening she received pneumonia injection.  On 11-11-08 whole arm was swollen from the shoulder down to her hand.  Swelling getting better after Benadryl and Prednisone - Another appointment at this clinic 11-14-08 to re-check arm/site.										11/10/2008	11/11/2008	1		PUB	PVT	Started 11-12-08 at ER after shots Benadryl; Prednisone; Atenolol; Elavit; Proventil; ASA; Buspar; Nexium; Detrol; Advair; Atrovent		HTN; COPD			1						1	Injection site erythema; Injection site pruritus; Injection site swelling	FLU3~SANOFI PASTEUR~U2770AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0978X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332326	11/13/2008	FL	57.0	57		M	11/13/2008	Immunization given 11/13/2008 11:40PM call placed to Take Care 11/13/2008 11:45PM c/o nausea coughing, chest tightness, sweating, blurry vision.				Y					U	11/13/2008	11/13/2008	0	See ER records	OTH	PVT	None	None	fish; milk			1						1	Chest discomfort; Cough; Hyperhidrosis; Nausea; Vision blurred; Chest discomfort; Cough; Hyperhidrosis; Nausea; Vision blurred; Blood test; Chest pain; Cough; Dysphonia; Dyspnoea; Eye discharge; Eye swelling; Hypersensitivity; Lethargy; Ocular hyperaemia; Upper respiratory tract congestion; X-ray	FLU3~SANOFI PASTEUR~U2831AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2831AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Emergency room visit	Influenza
0332327	11/13/2008	CA	11.0	11		M	11/10/2008	Rash all over body. Dermatitis/hives - SP Flu vaccine.				Y					Y	11/08/2008	11/09/2008	1	None	PUB	PUB		None	None			1						1	Dermatitis; Rash generalised; Urticaria	FLU3~SANOFI PASTEUR~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332329	11/13/2008	NH	31.0			F	11/10/2008	Pain (8/10) in right upper arm, swelling, numbness & tingling.				Y					U					PVT	OTH			Asthma			1						1	Hypoaesthesia; Oedema peripheral; Pain in extremity; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA350CA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332332	11/13/2008	KY	51.0	51		F	11/13/2008	Pain in left arm 2 weeks post FLUVIRIN given 10/27/2008. Pain and difficulty with manage of motion, continues to get worse, Per patient.									Y	10/27/2008	11/03/2008	7		OTH	OTH	VOVELLE DOT patch 0.5mg	None	None			1						1	Joint range of motion decreased; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88129~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0335113	11/13/2008	LA	4.0	4		F	11/01/2007	This case was received from a health professional on 25 September 2007, and is one in a cluster of three patients. The reporter is also the patient's father. A four-year-old female patient received an intramuscular deltoid injection of FLUZONE (lot number U2449AA) on 20 September 2007. Within 24 hours of vaccination, the patient developed an area of redness and soreness at the injection site, approximately two inches in diameter. The reporter diagnosed the event as cellulitis. The area was treated with antibiotic ointment, and the event resolved in two to three days. Follow-up information received on 23-October 2007. Information concerning the patient's birth weight and number of siblings was reported. In response to a query asking if the patient had received a previous dose of FLUZONE and if there had been any reactions, it was reported that the patient had received five previous doses of FLUZONE. It was not reported whether or not the patient had any reactions to previous FLUZONE vaccinations. Date of FLUZONE vaccination, previously reported as 20 June 2007 in the structured field, has been corrected to 20 September 2007. The correct vaccination date was previously reported in the narrative field. A corrective version of the case was created using the previous receipt date for the sole purpose of correcting the FLUZONE lot number in the product screen.									Y	09/20/2007	09/21/2007	1		PVT	UNK			No relevant medical history, no illness at time of vaccination		200703238	1						1	Cellulitis; Injection site erythema; Injection site pain; No reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~U2449AA~6~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335114	11/13/2008	LA	9.0	9		M	09/27/2007	This case was reported by a health professional in on 29 September 2007, and represents one out of three cases reported as a cluster. The reporter is also the patient's father. A nine-year-old male patient received an intramuscular deltoid injection of FLUZONE (lot number 02449AA) on 20 September. Within 24 hours of vaccination, the patient experienced redness and swelling at the injection site. The area was approximately two inches in diameter, and was diagnosed by the reporter as cellulitis. The event was treated with antibiotic ointment, and resolved within two to three days. This reporter also noted similar events in his daughter (2007-03238) and wife (2007-03240).									Y	09/20/2007	09/21/2007	1		PVT	OTH					200703239	1						1	Cellulitis; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~02499A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335115	11/13/2008	LA	40.0	40		F	10/08/2007	This case was reported by a health professional on 25 September 2007, and represents one of three cases reported as a cluster. The reporter is also the patient's husband. A 40-year-old female patient received an intramuscular deltoid injection of FLUZONE (lot number U2449AA) on 20 September 2007. Within 24 hours of vaccination, the patient experienced redness and swelling at the injection site. The area was approximately two inches in diameter, and was diagnosed by the reporter as cellulitis. The event was treated with antibiotic ointment, an resolved within two to three days. A corrective version was created on 08 October 2007 in order to note in the narrative that the case was reported on 24 September 2007, not 25 September 2007 as previously entered. No new information was provided. The reported also noted similar events in his daughter (2007-03238) and son (2007-03239).									Y	09/20/2007	09/21/2007	1		PVT	UNK			No relevant medical history; no illness at time of vaccine.		200703240	1						1	Cellulitis; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2449A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335116	11/13/2008	CA	50.0	50		M	10/01/2007	Initial report received from a health care provider on 28 September 2007. A 50-year-old male patient, who is a physician, had received an intramuscular left deltoid injection of FLUZONE, lot number U2441AA on 26 September 2007 and 24 hours later, experienced dizziness, lightheadedness, pallor and felt clammy. Blood pressure - pulse readings: lying - 110/70, 56, sitting - 118/70, 60 and standing - 130-90, 72. He was unable to continue seeing patients and was driven home. Five hours after the onset of symptoms, the patient stated they felt 80 percent better. The patient was reported to have received their flu vaccinations annually and had no prior events with prior flu vaccinations received. The patient had not been ill at the time of vaccination and had no pre-existing medical conditions. The patient had recovered from the event on 28 September 2007. No further information was provided.									Y	09/26/2007	09/27/2007	1	EKG, normal; CBC, normal; Glucose, 74	PVT	OTH					200703270	1						1	Activities of daily living impaired; Blood glucose normal; Cold sweat; Dizziness; Electrocardiogram normal; Full blood count normal; No reaction on previous exposure to drug; Pallor	FLU3~SANOFI PASTEUR~U2441A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335117	11/13/2008	CA	64.0	64		F	01/08/2008	Initial report received from a health care professional on 03 October 2007. A 64-year-old female patient with a medical history of a doxycycline allergy complained of dizziness, vertigo, headache, hives, heart palpitations, shakiness and weakness two to three days after she had received an intramuscular left deltoid injection of FLUZONE, lot number U2454AA. The reporter stated that the patient was feeling a little sick at the time of vaccination. It was unknown if the patient had received any vaccinations during the four weeks prior to vaccination or if the patient had been taking any concomitant medications. The patient was not evalutated by their physician and corrective treatments had not been reported. The patient had not experienced any adverse events following receipt of prior doses of FLUZONE. The patient's recovery status was listed as not recovered at the time of the report. Follow-up informatio was received from a health care professional on 07 January 2008. According to the reporter, they reviewed the case and had no additional information to provide at this time. The patient's recovery status remained as not recovered fromthe event. The reporting facility in this case is the same as in case 2007-03356.									N	09/27/2007	09/29/2007	2	Not reported	PVT	PUB			The patient had been feeling a little sick at the time of vaccination. The patient is allergic to doxycycline. It was unknown if the patient had been receiving any concomitant medications.		200703355	1						1	Asthenia; Dizziness; Headache; Palpitations; Tremor; Urticaria; Vertigo	FLU3~SANOFI PASTEUR~U2454A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335118	11/13/2008	MO				U	12/19/2007	A cluster of three adult patients, with no illness at the time of vaccination, had received intramuscular injections of FLUZONE SV 2007-2008, lot number U2438AA, on 18 October 2007. In the evening of the same day, the patients experienced fevers of 102 degrees Farenheit, stomach pain, and chills. Treatment included ibuprofen and liquid diet. At the time of this report, the event was still resolving, and the patient had not recovered. A corrective version was created with the same latest received date as the previous version (19 October 2007) for the sole purpose of adding to the narrative and the main screen (linked cases structure field) that the reporter for this case is the same as for cases 2007-03588, 2007-03589, and 2007-03590. No other relevant medically significant information was added to this case.									N	10/18/2007	10/18/2007	0		UNK	UNK			The patient's had no past medical history and no illness at the time of vaccine.		200703555	1						1	Abdominal pain upper; Chills; Pyrexia	FLU3~SANOFI PASTEUR~U2438A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335119	11/13/2008	PA	15.0	15		F	11/29/2008	Initial report received from a health care providers on 22 October 2007. A female patient with no pre-existing medical conditions, had received an intramuscular left deltoid injection of FLUZONE, lot number US444AA on 18 October 2007 and within 24 hours, she experienced chest pain which radiated to her back. The patient had no difficulty breathing. The patient was evaluated by her physician and diagnostic testing was performed. Echo and EKG - WNL; dates of testing were not provided. The reporter stated the patient had recovered from the evnet and no further information was provided at the time of the report. Follow-up information received on 26 November 2007 from a health care provider. There was no illness at the time of vaccination although other medications included ibuprofen. The date of the echocardiogram and electrocardiogram was 19 October 2007. The patient had a history of congenital absent pericardium of the left side of the heart and cardiomegaly secondary to absent pericardium (previously reported as no past medical history). The reporting facility in this case is the same as in case 2007-03559.				Y					Y	10/18/2007	10/19/2007	1	Echo and EKG, within normal limits	PVT	PVT	Ibuprofen		The patient has a past medical history of congenital absent pericardium of the left side of the heart with an associated cardiomegaly.		200703558	1						1	Back pain; Chest pain; Echocardiogram normal; Electrocardiogram normal	FLU3~SANOFI PASTEUR~U244A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335120	11/13/2008	PA	20.0	20		F	11/29/2007	Initial report received from a health care provider on 22 October 2007. An adult female patient with no pre-existing medical conditions, had received an intramuscular left deltoid injection of FLUZONE, lot number U2444AA on 18 October 2007 and within 24 hours, she experienced chest pain. The event resolved and no medical attention was required. Concomitant medicatons and illness at the time of vaccination were not reported. The reporter stated the patient had recovered from the event. No further information was provided. Follow-up information received on 28 November 2007 from a health care provider. Other medications included birth control pills. No diagnostic testing was performed. The patient had no illness at the time of vaccination. Additional medically relevant information was not provided. The reporting facility in this case is the same as in case 2007-03558.									Y	10/18/2007	10/19/2007	1	None reported	PVT	PVT	BIRTH CONTROL PILLS		The patient had no pre-existing medical conditions		200703559	1						1	Chest pain	FLU3~SANOFI PASTEUR~U2444A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335121	11/13/2008	OH				M	10/22/2007	Initial report received on 18 October 2007 from a health care professional in the United States. A male patient (demographics unknown), with unknown medical history, had received a right deltoid dose of FLUZONE SV 2007-2008 (lot number U2439AA) ON 16 October 2007. Two hours post-vaccination, the patient developed severe back pain. At the time of this report, the patient's pain was persisting and he was to be evaluated by a physician on 18 October 2007. Treatments received and diagnostic testing performed were not provided. At the time of this report, it was unknown it the patient had recovered.									U	10/16/2007				PVT	OTH			It was unknown it the patient had any illnesses, past medical history, or  use of other medications at the time of the vaccination of 16 October 2007.		200703523	1						1	Back pain	FLU3~SANOFI PASTEUR~U2439A~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335175	11/13/2008	OK	57.0	57		F		Initial report received on 31 October 2007 from a health care professional. A 57-year-old- female patient , with no illness at the time of vaccination, had received a left deltoid injection of FLUZONE SV 2007-2008, lot number U2464AA, on 19 October 2007. Needle used was a 27 gauge with a 1.5 inch length. The following day, the patient developed soreness at the injection site and intermittent twitching of the left arm. The event did not required medical examination. At the time of this report, the patient had recovered. The reporter in this case is the same as in case 2007-03693.									Y	10/19/2007	10/20/2007	1		PVT	OTH			Other medical history was unknown. Other medications included NEXIUM. The patient had no illness at the time of vaccination.		200703692	1						1	Injection site pain; Muscle twitching	FLU3~SANOFI PASTEUR~U2464A~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335176	11/13/2008	OK				F	11/02/2007	A female patient of reported unknown age had received a left deltoid, intramuscular injection of FLUZONE SV 2007-2008, lot number U2464AA, on 29 October 2007. Needle used was a 27 gauge with a 1.5 inch length. On the same day, the patient developed spontaneous, intermittent twitching of the left arm. There was no pain or soreness. The event did not require medical examination. At the time of this report, the patient had not recovered. The reporter in this case is the same as in case 2007-03692.									N	10/29/2007	10/29/2007	0		PVT	OTH			Illness at the time of vaccination was none. Other medications and past medical history were unknown.		200703693	1						1	Muscle twitching	FLU3~SANOFI PASTEUR~U2464A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335179	11/13/2008	NC	21.0	21		F	11/15/2007	A 21 year old, female patient (with no medical history) experienced her tongue turn brown, a dark brown, approximately 2 hours after she received FLUZONE (lot number U2529AA) intramuscularly in the left deltoid on 10 November 2007. There was no swelling and no other symptoms were reported. Benadryl was given. She did not have any illness at the time of vaccination and was not on any medications. At the time of the report, the patient's recovery status was unknown.				Y					U	11/10/2007	11/10/2007	0		OTH	PVT					200703847	1						1	Tongue discolouration	FLU3~SANOFI PASTEUR~U2529A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335181	11/13/2008	NY	47.0	47		F	01/14/2008	Initial report received from a consumer on 15 November 2007. A 47 year-old female patient with a history of a penicillin allergy, had received an intramuscular left deltoid injection of FLUZONE (lot number not reported) on 13 November 2007 and the evening of vaccination developed warmth, redness, itching and swelling at the injection site; reported to be the size of a softball. The patient had not received any vaccines during the four weeks prior to receipt of FLUZONE. The patient reportedly experienced this same type of event in the past after receipt of Lovenox and heparin. The patient had not been evaluated by a physician and had not received any doses of FLUZONE in the past. At the time of the report, the patient had not recovered from the event. Follow-up information received on 11 January 2008 from a physician. The patient was taking Lovaxil at the time of the vaccination on 13 November 2007. The FLUZONE was reported as U2531AA and the vial had an expiration date of 30 June 2008. The adverse events that was previously reported started at 1:30 p.m., one hour post-vaccination with FLUZONE vaccine on 13 November 2007. At the time of this report, the patient had recovered. No further information is expected.									Y	11/13/2007	11/13/2007	0	Not reported.	PVT	PVT	Lovaxil		The patient had not been ill at the time of vaccination. Concomitant medications were not reported. The patient had a penicillin allergy. The patient also reported that this same type of event occurred in the past after receiving of Lovenox and heparin. From new information received on 11 January 2008, the patient had not received any other vaccinations within four weeks of 13 November 2007.		200703898	1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2531AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335182	11/13/2008	VA	56.0	56		F	11/19/2007	A 56-year-old with a history of recent stem cell transplant one month prior, had received a left deltoid injection of FLUZONE SV 2007-2008, lot number U2493AA, on 08 November 2007. Two days later, the patient developed mouth sores. Other medications included Ambien, Crestor, Diovan, metolazone, and Lasix. The event did not required examination by a physician. Recovery status was unknown.									U	11/08/2007	11/10/2007	2		OTH	OTH	AMBIEN, CRESTOR, DIOVAN, METOLAZONE, LASIX		The patient had a history of stem cell transplant one month prior to vaccination and allergies to Prevacid, Bactrim, and Percocet.		200703899	1						1	Stomatitis	FLU3~SANOFI PASTEUR~U24933A~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335183	11/13/2008	NC	30.0	30		M	11/20/2007	A 30-year-old male patient, with no illness at the time of vaccination, had received a left arm, intramuscular injection of FLUZONE SV 2007-2008, lot number U2526AA, on 15 November 2007. Two minutes post-vaccination, the patient stood up, began walking, and felt lightheaded and dizzy. He also experienced sweating and ringing in his ears. The patient's blood pressure was checked and found to be 90/72, sitting. He was provided to glasses of water to drink after which his symptoms began to subside. Subsequent blood pressure readings were 102/78, 100/78 and 110/89. After 30 minutes, the patient completely recovered. Follow-up information received on 20 November 2007 from a health care professional. The reporter confirmed that the patient had not died and that the death date was filled out in error on the VAERS form.									Y	11/15/2007	11/15/2007	0		UNK	UNK			The patient had no illness at the time of vaccination, no other medications, and no past medical history.		200703902	1						1	Blood pressure decreased; Dizziness; Hyperhidrosis; Immediate post-injection reaction; Tinnitus	FLU3~SANOFI PASTEUR~U2526A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335184	11/13/2008	AZ	34.0	34		F	11/28/2007	Initial report received on 21 November 2007 from a health care professional. A 34-year-old female patient had received a left deltoid injection of FLUZONE, lot number U2486AA, and a right deltoid injection of PNEUMOVAX, manufacturer Merck, lot number 1417U; on 20 November 2007. Later that evening, the patient experienced left arm pain extending into the left axilla and left neck and a fever of 101.0 degrees Fahrenheit. At the time of this report, the patient had not recovered.									N	11/20/2007	11/20/2007	0		PVT	PVT	Zocor;Lisinopril;Hydpochlorothiazide;Amitriptline, ASA		The patient had a history of migraines, hypertension, hperlipidemia, MI thought to be secondary to Triptan use, angioplasty of the LAD with stent placement.		200704010	1						1	Neck pain; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U2486A~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1417U~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0335187	11/13/2008	NJ	2.0	2	.4	M	07/07/2008	Initial information was received from a health care professional on 19 December 2007. Follow up information was received from a health care professional in the on 20 June 2008. Based upon this new information a narrative has been created for this case. A two year old-male patient with no past medical history received a fourth injection of FLUZONE (lot number U2476GA), on 04 November 2007. According to the patient's mother approximately six hours after vaccination, the patient began experiencing edema of hands and feet and hives. The day after vaccination he was seen by his physician and treated with Benadryl. The treating physician suspected a viral illness vs. a vaccine reaction. The patients symptoms resolved within 2 days.									Y	11/04/2007			No labs reported.	PVT	PVT			The patient had a runny nose nand low grade fever at the time of vaccination.		200704390	1						1	Oedema peripheral; Urticaria	FLU3~SANOFI PASTEUR~U2476G~4~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335188	11/13/2008	VA	28.0	28		F	01/17/2008	Initial information received on 26 October 2007 from a health care professional.  A 28-year-old female patient, with a history of panic attacks and who was pregnant (33 weeks gestation), had received a left deltoid, intramuscular injection of Fluzone SV 2007-2008, lot number U2469AA on 24 October 2007. Fifteen minutes post-vaccination the patient experienced an anxiety attack with hyperventilation, anxiety and trembling. She refused transport to an emergency room. The patient was contacted one hour later following the event and was fine. The patient recovered from the event. Follow-up informaion was received from a health care professional on 16 January 2008. The reporter stated that the vaccine had been administered in a retail pharmacy setting and indicated that they have no access to the patient's medical records or information. According to the consent form completed by the patient prior to immunization, the patient had no egg allergies and no prior reactions to any vaccines in the past requiring medical care. The reporter provided a copy of the patient's consent form which contained contact information for the patient's physician. No futher information was provided.									Y	10/24/2007	10/24/2007	0		OTH	OTH	Prenatal vitamins		The patient has no illness at the time of vaccination.  Other medications included pre-natal vitamins. She was 33 weeks pregnant at the time of  the event. The patient had a history of panic attacks.		200703669	1						1	Anxiety; Drug exposure during pregnancy; Hyperventilation; Tremor	FLU3~SANOFI PASTEUR~U2469A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335189	11/13/2008	IL	58.0	58		F	01/08/2008	Initial report received on 29 October 2007 and follow-up received on 07 January 2008 from a health care provider. The initial information received contained listed events; and, upon follow-up, the final diagnosis was an unlisted event. A 58-year-old female patient, with no illness at the time of vaccination, had received a left deltoid, intramuscular injection of FLUZONE SV 2007-2008, lot number U2464AA, on 26 October 2007. Twenty-four hours post-vaccination, the patient experienced redness and swelling of approximately half of the area between the shoulder and elbow, and the injection site was warm to touch. The diameter of the area was approximately three inches. The final diagnosis of the event was aseptic cellutitis. Treatment included TYLENOL and KEFLEX. The patient subsequently recovered on 05 November 2007. The reporter for this case is the same as for case 2007-03679.									Y	10/26/2007				PVT	PVT	Labatrol; Hydrochlorizide; PREMARIN; Multivitamin		At the time of vaccination on 26 October 2007, the patient denied any concurrent illnesses, and had no known allergies, but had pre-existing medical history of increased blood pressure that was being treated with Labatrol (LABETALOL) and Hydrochlorizide (HYDROCLOROTHIAZIDE). The patient denied having any adverse events with prior vaccinations, and did not received any other vaccinations within four weeks of the vaccination on 26 October 2007. The patient receives annual flu vaccines.		200703678	1						1	Cellulitis; Erythema; Injection site warmth; Oedema peripheral	FLU3~SANOFI PASTEUR~U2464A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335190	11/13/2008	FL				U	11/02/2007	Initial report received from a health care professional on 30 October 2007. Cluster of 50 cases of dark grey dots appearing instantly after injection out of an unspecified number vaccinees who had received an intramuscular deltoid injection of FLUZONE, lot number U2488AA. The reporter stated that they use B-D regular syringes, 25 gauge, one inch. The injection site had been prepped with Kendall Curity alcohol wipes. The dark grey mark appeared after all doses withdrawn from the vials and appeared instantly following injection. The reporter had not checked to observe it the dots disappeared later on and did not know how long the dots remained at the injection site. The reported event had been observed by all of the health care workers providing FLUZONE immunizations this year but had not been observed in prior years. The reporter stated they used FLUZONE and the same syringes in prior years. All 50 of the reported patients had recovered from the event.									Y				None reported	UNK	UNK			Not reported		200703630	1						1	Immediate post-injection reaction; Injection site discolouration	FLU3~SANOFI PASTEUR~U2488A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335191	11/13/2008	MT				F	12/05/2007	Initial report received on 30 November 2007 from a health care professional. A female patient (age unknown) had received an injection of FLUZONE SV 2007-2008, lot number unknown, and route and site of administration unknown, on an unknown date. Within one hour post-vaccination, the patient developed anxiety, nausea, and itching. The event did not require medical examination. The subject subsequently recovered. The reporter in this case is the same as in case 2007-04123. In that case events were reported following administration of Tubersol 5 TU.									Y					PUB	OTH			Illness at the time of vaccination, other medications, and past medical history were unknown.		200704122	1						1	Anxiety; Nausea; Pruritus	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335192	11/13/2008	WI	39.0	39		M	08/08/2008	Initial report received on 10 January 2008 from a health care professional. A 39-year-old male patient, who had no concurrent illness, pre-existing medical conditions, or use of other medications had received a dose of FLUZONE SV 2007-2008 (lot number U2464AA) on 18 October 2007. The route and site of administration was not provided. The following day, after receiving the FLUZONE vaccine. the patient experienced a staph infection. No relevant diagnostic tests, or laboratory data were performed to confirm the diagnosis of staph infection. At the time of this report, the patient had recovered. No other relevant medically significant information was provided. Follow-up information was received 08 August 2008 from a health care professional. The reporter reviewed the case information and had no new relevant medically significant information to provide at the time of the report. The reporter for this case is the same for case 2007-03565, which is a case for a 55-year-old female who developed a staph infection after administration of the FLUZONE SV2007-2008 on 16 October 2007.									Y	10/18/2007	10/19/2007	1		OTH	PVT			The patient had no concurrent illnesses, pre-existing medical conditions, or use of other medications at the time of the vaccination with FLUZONE SV 2007-2008 on 18 October 2007.		200800094	1						1	Staphylococcal infection	FLU3~SANOFI PASTEUR~U2464A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335193	11/13/2008	MA	58.0	58		F	01/18/2008	This case was received from a health professional on 17 January 2008. A 58-year-old female patient received an injection of FLUZONE (lot number U2444AA) on 12 December 2007. The patient had a history of allergies to egg, penicillin, pollen, and  other food. On 16 December 2007, four days after vaccination, the patient developed constant muscle aches, which she described as being worst in her arms and legs. She also complained of extreme fatigue. She was treated with prednisone, with little effect, and was later seen in the emergency department. Laboratory work-up, including CBC and ESR, were performed in the emergency department, but results were not provided. She was seen by an ENT (ear, nose and throat specialist) and diagnosed with a sinus infection. On 17 January 2008, she underwent protein electrophoresis testing, the results of which were not provided. At the time of the report, the events had not resolved. Per the reporter, the patient had experienced a similar event following last flu vaccine. Concomitant medication included PROZAC, Avista, Vitamins, Calcium, and monthly flu shots. In addition to allergy history, the patient also had a medical history of osteoporosis.				Y					N	12/12/2007				PVT	PVT	PROZAC; Avista; Vitamins; Calcium; Allergy shots		Patient has history of allergies to eggs, penicillin, pollen, and other food. Medical history included osteoporosis. She had experienced a similar event following last flu vaccination.	Adverse event NOS~Influenza (Seasonal) (no brand name)~UN~0.00~In Patient	200800165	1						1	Electrophoresis protein; Fatigue; Full blood count; Myalgia; Red blood cell sedimentation rate; Sinusitis	FLU3~SANOFI PASTEUR~U2444A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335194	11/13/2008	VA	3.0			U	01/22/2008	Initial report was received from a health care professional on 18 January 2008. A 3-year-old child with no past medical history, had received an intramuscular, left deltoid injection of FLUZONE SV (lot number invalid). On an unspecified date and approximately two days later, the child developed a fever of 103.5 degrees Fahrenheit and their left arm became very reddened and swollen from the shoulder and axillary areas down to their mid arm and hard at the injection site. The needle size utilized had been 25 gauge, 5/8 inch length. Corrective treatments included TYLENOL, BENADRYL, and an antibiotic. The patient had no known allergies and had not received any other vaccines during the four weeks prior to receipt of FLUZONE SV. At the time of the report, the patient had not recovered from the event.				Y					N				None reported	OTH	OTH			The patient had no illness, no pre-existing medical conditions and had not been taking any concomitant medications at the time of vaccination. The patient had not recovered any other vaccinations during the four weeks prior to FLUZONE vaccination.		200800213	1						1	Injection site erythema; Injection site induration; Injection site swelling; Pyrexia	FLU3~SANOFI PASTEUR~U244A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335195	11/13/2008	CA	7.0			F	05/06/2008	Initial report received 29 April 2008 from a health care professional. A seven-year-old female patient had received an intramuscular left deltoid injection of FLUZONE, lot number U2440AA (0.5mL) on 31 October 2007 and immediately following vaccination. a black dot appeared at the injection site. According to the reporter, the recovery status of the patient was unknown at the time of the report. The reporter received a cluster of reports of black dots at the injection site from multiple satellite locations who were all affiliated with the reporter. The facilities used McKesson alcohol wipes and syringes which included safety glide and vanish point with 25 gauge needles. Some of the black dots were reported to have appeared immediately with some present two months post immunization. This event had been noticed by all health care worker at the facilities and had not been noticed in the past. The reporter indicated follow-up information would be provided as it is obtained. The reporter for this case is the same as for case number 2008-01333 (IPOL and ActHIB), 2008-01334 (IPOL), 2008-01335 (IPOL), 2008-01336 (IPOL and DTaP) and 2008-01339 (IPOL). These events occurred at multiple satellite locations which are all affiliated with the reporter.									U	10/31/2007	10/31/2007	0	Not reported	PVT	UNK			Not reported		200801339	1						1	Immediate post-injection reaction; Injection site discolouration	FLU3~SANOFI PASTEUR~U2440AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335196	11/13/2008	WI	4.0	4		F	05/30/2008	Initial report received on 14 May 2008 from a health care provider. A four year old female patient received on 21 November 2007 a third right deltoid intramuscular injection of FLUZONE (lot number U2452AA). On February 2008 84, days post vaccination, the patient had a white peace sign type ring, measuring 3.5 cm by 2.5 cm, on the deltoid injection site. The patient had no medical history, except for an allergy to amoxicillin (urticaria), and had no illness at the time of vaccination. Corrective treatment was not reported. At the time of the report, the patient had not recovered.									N	11/21/2007	02/13/2008	84		UNK	UNK			No medical history. Allergic to amoxicillin - urticaria. No illness at time of vaccination.		200801586	1						1	Injection site discolouration	FLU3~SANOFI PASTEUR~U2452A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335198	11/13/2008	NJ	8.0	8		M	01/02/2008	This case was received form a health professional on 05 October 2007.  An eight-year-old male patient with an allergy to penicillin received an intramuscular injection of FLUZONE (lot number U2461BA) on 22 September 2007.  Within two days he developed redness at the site, which subsequently turned into a  15 cm brown spot.  The patient had not been seen by a physician.  Per the reporter, the patient had received FLUZONE in 2006, and had not experienced any adverse events following vaccination.  At the time of report, the events remained ongoing.  Follow-up information received on 08 January 2008 from a physician.  Per the reporter, the patient suffered no ill effect from the adverse events, and was subsequently re-evaluated by a physician and found to have no symptoms.  The date of re-evaluation was not reported.  It was not reported whether the patient received any other treatments.  The patient recovered.  No further information is expected.									Y	09/22/2007	09/24/2007	2		PVT	PVT			Allergy to penicillin as other medical history, no illness at time of vaccination.		200703381	1						1	Injection site discolouration; Injection site erythema; No reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~U2461B~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335199	11/13/2008	NJ	7.0	7		M	10/25/2007	Initial report received on 19 October 2007 from a nurse. A seven-year-old male patient, with no concurrent illnesses, or pre-existing medical history had received a left arm intramuscular dose of FLUZONE No Preservative 2007-2008 (lot number UZ461BA) on 04 October 2007. The following day, the patient began having swelling, redness, itchiness at the injection site that progressed to include the area between the shoulder and elbow with no joint involvement. At an unspecified amount of time after receiving the vaccine, the patient developed blistering below the injection site. The patient was evaluated by a physician and treated with BACTROBAN, BENADRYL, and ADVIL. No diagnostic tests or laboratory data were performed. At the time of this report, the patient was recovered and was to have testing for allergies.				Y					Y	10/04/2007	10/05/2007	1		PVT	PVT			The patient had no concurrent illnesses, pre-existing medical history, adverse events with prior vaccinations, or use of other medications at the time of the vaccination on 04 October 2007. The patient had no other vaccinations within four weeks prior to 04 October 2007.		200703463	1						1	Blister; Injection site erythema; Injection site pruritus; Injection site swelling	FLU3~SANOFI PASTEUR~U2461B~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335201	11/13/2008	IL	15.0	15		F	01/08/2008	Initial report received on 14 November 2007 from a health care professional.  A 15-year-old female patient, who had a history of depression and attention deficit disorder, had received a sixth dose, left upper arm, intramuscular injection of FLUZONE SV 2007-2008, lot number U2479CA; and a third dose, right upper arm, intramuscular injection of GARDASIL, manufacturer MERCK, lot number 1266U; on 13 November 2007.  The patient subsequently woke up at midnight on the same day as vaccination and felt like bugs were crawling on her skin.  She also had generalized itching.  The next morning, she experienced soreness at of the left upper arm.  Examination in a medical office showed a low grade temperature of 100.3 degrees Fahrenheit with clear skin.  The patient was in no distress.  Treatment provided was not reported.  Concomitant medications included CONCERTA and PROZAC.  At the time of this report, the event was resolving.  A corrective version was treated on 15 November 2007 with the LRD of the previous version 14 November 2007 in order to amend the product described in this narrative to FLUZONE No Preservative 2007-2008 (previously documented as FLUZONE SV 2007-2008).  Follow-up information received on 07 January 2008 from a health care professional.  No laboratory testing was performed.  The patient recovered.				Y					Y	11/13/2007	11/13/2007	0		UNK	UNK	CONCERTA; PROZAC		The patient had history of depression and attention deficit disorder.		200703880	1						1	Body temperature increased; Formication; Injection site pain; Pruritus generalised	FLU3~SANOFI PASTEUR~U2479C~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1266U~3~IM~RA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0335202	11/13/2008	IN				U	10/23/2007	Initial non-serious report received from a purchaser on 18 October 2007.   A cluster of seven unidentified patients received injections of FLUZONE (lot number U2466AA) on various days at three different facilities.  The reporter indicated that many unusual reactions, which were more than local reactions, had been observed.  Five employees at a hospital location where FLUZONE was given with 23 gauge, one inch needles experienced arm swelling/cellulitis.  One individual received treatment with KEFLEX.  Two other facilities each had one patient with the same type of reactions.  Some patients complained of itching.  Some patients required doctor visits.  The reporter also indicated they have had many other patients with local reactions described as redness.  The reporter mentioned that they often prefill syringes for short periods of time.  Recovery status was not reported.  No additional information has been provided at the time of the report.  The reporter of this case is the same as for case 2007-03531, which involves cellulitis following receipt of FLUZONE, lot number U2446AA.				Y					U					UNK	UNK			The reporter provided a response of Varies to the questions concerning illness at time of vaccination, concomitant reactions and pre-existing allergies/medical conditions.		200703529	1						1	Cellulitis; Erythema; Local reaction; Oedema peripheral; Pruritus	FLU3~SANOFI PASTEUR~U2466A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335203	11/13/2008					U	07/03/2008	Background Trivalent inactivated influenza vaccine (TIV) is not licensed for use in infants <6 months old, the group with the highest influenza hospitalization rates among children. Methods. In this prospective, open-label study, 2 doses of TIV were administered to healthy infants aged 10-22 weeks. Adverse reactions were assessed, and hemagglutination inhibition (HAI) antibody titers were determined. Weekly telephone surveillance for influenza-like illness was conducted during the influenza season. Results. A total of 42 infants were enrolled and completed the study. Mild local and systemic reactions were noted. In the first season (2004-2005), post vaccination HAI titers > 1:32 were noted for 3 1.6%, 47.4%, and 21.1% of 19 subjects for H1N1, H3N2, and B strains included in the vaccine, respectively. In the second season (2005-2006), post vaccination HAI titers > 1:32 were seen in 45.5%, 58.1%, and 0% of 23 subjects for HIND, H3N2, and B strains included in the vaccine, respectively. In the second season (2005-2006), postvaccination HAI titers >1:32 were seen in 45.5%, 59.1%, and 0% of 23 subjects for HINI, H3N2, and B strains included in the vaccine, respectively. Infants who were seronegative before vaccination (titers < 1:8) were significantly more likely to have a 4-fold rise in antibody liter after vaccination, compared with infants who had prevaccination titers >1:8 (P < .001). Conclusion. Two doses of TIV were found to be safe and moderately immunogenic against some influenza strains. The presence of preexisting maternally derived antibody was associated with significantly lower zero response rates to vaccination. Whether vaccination with TIV will prevent influenza in three young children remains to be determined.				Y					U					UNK	UNK					200802008	1						1	Antibody test; Local reaction; Nonspecific reaction	FLU3~SANOFI PASTEUR~~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0336111	11/13/2008	WI	55.0	55		F	08/10/2008	A cluster of 2 unidentifiable patients, who received on an unspecified date FLUZONE (lot # U2484AA) and experienced staph infection.  Initial report received on 22-October 2007 from a health care professional.  2 unidentifiable patients received on an unspecified date FLUZONE (lot # 00464AA) and experienced staph infection.  There were no proven cultures.  No other information was provided.  Follow-up information received on 10 January 2008 from the original reporting health care professional.  The two patients have been identified, and this case will now serve as the case for the 55 year-old female patient.  Who had no concurrent illness, pre-existing medical conditions, or use of other medications at the time of administration was not provided.  The following day, after receiving the FLUZONE vaccine, the patient experienced the staph infection.  No relevant diagnostic tests, or laboratory date were performed to confirm the diagnosis of staph infection.  At the time of this report, the patient had recovered.  No other relevant radically significant information was provided.  Follow-up information was received 21 July 2008 from a health care provider.  The reporter reviewed the case information and had no new relevant medically significant information to provide at this time.  Follow-up information was received on 11 August 2008 from a health care provider.  The patient received an injection of FLUZONE in the left deltoid.  The patient's staph infection occurred at the injection site.  The reporter for this case is the same as for case 2008-00094, which is the case for the other identified patients, who was a 39-year-old male patient who developed a staph infection after administration of the FLUZONE SV 2007-2008 on 18 October 2007.									Y	10/18/2007	10/19/2007	1	None	OTH	PVT			The patient had no concurrent illnesses, pre-existing medical conditions, or use of other medications at the time of the vaccination with FLUZONE SV 2007-2008 on 18 October 2007.		200703565	1						1	Staphylococcal infection	FLU3~SANOFI PASTEUR~U2484AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336114	11/13/2008	IN				M	10/13/2007	Initial non-serious report received from a non-health professional on 19-October 2007.  A male patient (age unknown) had received FLUZONE (lot number 02464AA; route/site of administration not indicated) on an unspecified date in 2007.  He developed cellulitis (location and onset date not reported) and received treatment with KEFLEX.  The FLUZONE vaccination was administered with a 23 gauge, one inch needle.  Patient outcome was not reported.  No additional information has been provided at the time of the report.  The reporter of this case is the same as for case 2007-03529, which involves cellulitis, swollen arm, itching and injection site redness following receipt of FLUZONE, lot number U2466AA.									U					UNK	UNK			It was unknown if the patient had any illness at the time of vaccination, if the patient was taking any concomitant medication, if the patient had any pre-existing allergies/medical conditions or if the patient had received any other vaccinations with four weeks prior to receiving FLUZONE.		200703521	1						1	Cellulitis	FLU3~SANOFI PASTEUR~U2466A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336115	11/13/2008	NY	21.0	21		F	11/19/2007	A 21-year-old female patient with no medical history, had received an intramuscular left deltoid injection of FLUZONE sv 2007-2008, lot number U2505AA on 13 November 2007 and one day later, the injection site became swollen, red, hot and sore.  Swelling was the size of a tennis ball.  The following day, swelling had increased to the size of a softball.  The entire arm was sore, muscular pain down to her fingers.  The patient was evaluated by her physician on 15 November 2007 and prescribed Prednizone.  The patient had not received any vaccines during the four weeks prior to receipt of FLOZONE.  Symptoms were still persistent at the time of the report and the patient had not recovered from the event.  No further information was provided.									N	11/13/2007	11/14/2007	1	None	PVT	PVT			The patient had not been taking concomitant medications and had not been ill at the time of vaccination.  The patient had no known drug allergies.		200703897	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Myalgia; Pain in extremity	FLU3~SANOFI PASTEUR~U2505A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336116	11/13/2008	NV	74.0	74		F	12/04/2007	Initial report received on 04 December 2007 from the patient's family member.  A 74-year-old female patient had received an injection of FLUZONE SV 2007-2008, lot number U253AA (not a valid sanofi pasteur lot number) on either 04 November 2007 or 30 November 2007.  Per the reporter, at an unspecified time post-vaccination, the patient experienced confusion.  She turned the wrong way going to the store and was unable to balance her checkbook.  The reporter indicated that this was abnormal for the patient.  An appointment was scheduled for medical examination.  At the time of this report, the patient had not recovered.				Y					N	11/30/2007	11/30/2007	0		UNK	UNK	Water Pill; Pill for Diabetes		The patient was taking medication for diabetes and a water pill.		200704171	1						1	Abnormal behaviour; Confusional state	FLU3~SANOFI PASTEUR~U053AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0336117	11/13/2008	CA	42.0	42		F	10/05/2008	Initial report was received from a consumer on 01 January 2008.  A 43-year-old female patient with no medical history, had received a left deltoid (route not reported) injection of FLUZONE SV 2007-2008, lot number U2515AA during October 2007 (date not specified) and approximately one week following vaccination on 18 October 2007, she developed extreme nausea and vomiting and diarrhea.  The diarrhea subsided some time in December.  Relevant laboratory testing including an upper GI in which the results indicated gastritis.  Corrective treatments included NEXIUM.  The patient had not received FLUZONE in the past and was reported to have had sinus symptoms the day of vaccination.  The patient reported a 28 pound weight loss since October and at the time of the report, the symptoms of nausea and vomiting continued.  No further information was provided.  25/Jan/2008:  Corrective version was created for the purpose of re-ranking the adverse event terms.  The adverse event outcome for the event of diarrhea on the adverse event screen was also amended from not recovered to recovered.				Y					N	10/01/2007	10/18/2007	17	Upper GI - indicated gastritis	PUB	OTH			The patient had no known allergies, no past medical history and had not been taking concomitant medications at the time of vaccination.  The patient had sinus symptoms the day of vaccination.		200800219	1						1	Diarrhoea; Gastritis; Nausea; Vomiting; Weight decreased; X-ray with contrast upper gastrointestinal tract	FLU3~SANOFI PASTEUR~U2515A~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0210777	11/14/2008	TX	25.0	25		M	07/31/2006	Chronic headaches and fatigue with memory changes and wheezing when extremely tired- See clinic summary. Symptoms started after patient was diagnosed with myocarditis Oct 2003.				Y					U	10/14/2003			See VHC clinical summary	MIL	MIL	None at time of vaccine receipt	None	Allergic to PCN Hx of knee injury- See VHC Clinical summary and previous VAERS report			1						3	Fatigue; Headache; Memory impairment; Myocarditis; Wheezing	FLUX~UNKNOWN MANUFACTURER~765141~7+~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|SMALL~PFIZER\WYETH~4020071~1~~UN~SMALLPOX (DRYVAX)~3|TYP~SANOFI PASTEUR~W0909~2~UN~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~3	USA	Emergency room visit	Influenza
0331323	11/14/2008	OR	79.0	79		F	10/30/2008	I had a flu shot on October 2, 2008, Thursday at local store at about 11:30 AM appx. By mid afternoon my left arm and shoulder seemed very sore and painful. It seemed the shot was given much higher up on my arm, near the top close to the shoulder. Prior ones were lower down the arm. By Sunday evening I was in great pain and took some ALEVE, changed to aspirin if see if it would better for the pain. Then on Thursday AM (October 9th) this large bluish nodule appeared on top of my left hand near the knuckles. Went to ER at hospital said it was hematoma. Doctor there said I should take Ibuprofen to ease the pain in my arm and shoulder to help the inflammation I end up with a stiff or frozen shoulder (still can't get my arm up  over my head to this day. From ER went to primary doctor, was sent to hand specialist and a bone and joint clinic, now in physical therapy. also had shoulder X-Ray taken (10-15-08) may need MRI in the next week if not better. have been in therapy since October 20,2008. Now a large red spot has shown up on my back of arm near top. Seen Dr on Friday, October 30th to look at the red spot. Still not recovered yet, can't rise left hand on its own over myhead				Y					N	10/02/2008	10/02/2008	0		OTH	OTH	TIMOPTIC XE for eye- __ thyroid- Multi vitamin	None	Allergic  Codeine			1						2	Contusion; Injection site pain; Cyanosis; Erythema; Haematoma; Inflammation; Injected limb mobility decreased; Musculoskeletal pain; Musculoskeletal stiffness; Pain in extremity; Periarthritis; Skin nodule	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89123~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89123~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0331530	11/14/2008	UT	30.0	30		F	11/01/2008	After receiving first time FLUZONE pt complains of dizziness and feeling odd after 20 min. No respiratory distress. Later complain of difficulty breathing; tiredness; and increased dizziness. 2mg CHORPHENIRAMINE given times 2 days, blood pressure 133 0ver 104 after 10 minutes blood pressure 130 over 110 and patient complain of throat feeling smaller and difficulty breathing. 3ml EPINEPHRINE given. 911 called client transported to ER per ambulance.				Y					Y	10/29/2008	10/29/2008	0		PUB	PVT	SEROQUEL; ZOLOFT; NEURONTIN	None	Depression			1						2	Blood glucose; Blood pressure fluctuation; Delirium; Dissociation; Dizziness; Dyspnoea; Electrocardiogram; Heart rate abnormal; Immediate post-injection reaction; Oxygen saturation; Pallor; Throat tightness; Blood pressure increased; Dizziness; Dyspnoea; Fatigue; Feeling abnormal; Throat tightness	FLU3~SANOFI PASTEUR~U284AC~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2849AC~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0331536	11/14/2008	NM	11.0	11		M	10/23/2008	He said he did not feel good around 4PM yesterday. Around 9PM he said he was hot. His face, ears, neck, and shoulders were blood red and very hot to the touch. He then was saying he was hot, then going back to cold. He went back and forth on that. he said his arms around the shot sites were hot and itching the left arm had a little whelp that looked sort of like a small worm. Today it is much bigger than that and still hot and itching.				Y					Y	10/22/2008	10/22/2008	0		MIL	MIL	Zyrtec-PM, Cingulair-AM	None	Asthma, Allergy-Augmentin			1						2	Erythema; Feeling cold; Feeling hot; Hot flush; Injection site pruritus; Injection site warmth; Malaise; Erythema; Feeling of body temperature change; Injection site pruritus; Injection site streaking; Injection site urticaria; Injection site warmth; Malaise; Skin warm	FLU3~SANOFI PASTEUR~U2833AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB246AA~1~IM~RA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2683AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2899AA~1~IM~LA~TDAP (ADACEL)~1|FLU3~SANOFI PASTEUR~U2833AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB246AA~UNK~IM~RA~HEP A (HAVRIX)~2|MNQ~SANOFI PASTEUR~U2683AA~UNK~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TDAP~SANOFI PASTEUR~C2899AA~UNK~IM~RA~TDAP (ADACEL)~2	USA	Emergency room visit	Influenza
0332103	11/14/2008	NM	56.0			F	11/12/2008	Pt complaint of S.O.B and wheezing, she also stated that the vaccine site was red, swollen warm to the touch. The on call Dr. gave her instructions to follow up with immunization the next morning.									Y					MIL	MIL		None	None			1						2	Dyspnoea; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Wheezing; Dyspnoea; Injection site erythema; Injection site swelling; Injection site warmth; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197AA~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~2	USA		Influenza
0332232	11/14/2008	NJ		52		F	11/14/2008	C/o pain in left upper arm (shoulder to elbow) moving arm with difficuty due to pain. Stated,sl better today advised to call PMD										10/21/2008	10/21/2008	0		UNK	PUB						1						2	Pain in extremity; Injected limb mobility decreased; Pain in extremity; Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2787EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U27870~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~U27870~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA		Influenza
0332326	11/14/2008	FL	58.0	57		M	11/14/2008	Received shot at approximately 12:00 Noon.  Went home and took a nap for about 1 hour.  Got up-felt lethargic. About 3:00 started feeling/sounding a little congested. He took some Claratin.  At approximately 4:00 breathing started getting more and more restricted, coughing, raspy voice, chest pain, swollen around eyes, Very red, blood shot eyes, oozing from eyes.  Breathing became difficult. He took Benadryl.  We tried to call the clinic.  We waited for them to call back.   (4:45)We drove there.  The nurse said to go to the emergency room.  At the emergency room (5:30) they took blood, gave him a shot of steroids, did a breathing treatment, took an xray.  He was told that he had had an allergic reaction.  He was released at approximately 8:30pm.  He was prescribed steroids and benydryl. Times are approximate-not exact.  Next day:  He is recovering but not back to normal.				Y					N	11/13/2008	11/13/2008	0		UNK	PVT	none	none	food allergies: fish, peanuts, milk, wheat			1						3	Chest discomfort; Cough; Hyperhidrosis; Nausea; Vision blurred; Chest discomfort; Cough; Hyperhidrosis; Nausea; Vision blurred; Blood test; Chest pain; Cough; Dysphonia; Dyspnoea; Eye discharge; Eye swelling; Hypersensitivity; Lethargy; Ocular hyperaemia; Upper respiratory tract congestion; X-ray	FLU3~SANOFI PASTEUR~U2831AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2831AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Emergency room visit	Influenza
0332344	11/14/2008	PA	16.0	16		F	11/13/2008	Information has been received from a mother and aunt concerning a 16 year old female patient with no known medical history, who was vaccinated with all three doses of GARDASIL by June 2008. Concomitant suspect vaccination included influenza virus vaccine (unspecified) (name and manufacturer unspecified). The consumer reported that her niece was HPV (unknown type) positive after getting all three doses of GARDASIL. The mother subsequently reported that about one month after receiving all three doses of GARDASIL her daughter had a yeast infection and then two weeks later had another infection. The patient was the due for her yearly checkup and so she went and had a pap test done and the test showed the patient had genital warts and a large lesion on her insides. The mother stated that her daughter is going to a specialist and will have to get some work done on her for the lesions. The mother reported that the patient does not feel well and has a loss of appetite. It also reported that the patient received the flu vaccine and wound up in the hospital (specifics not provided). The patient sought unspecified medical attention. At the time of the report it was reported that the patient was not recovered. No further information is available.  1/28/2009 MR received for GYN visit 12/5/08 for colposcopy for (+) PAP smear. Final DX: Mild to moderate dysplasia with HPV.				Y					N	04/18/2008	07/01/2008	74	gynecological, the patient had genital warts and large lesion on her insides; Pap test, the patient had genital warts and large lesion on her insides. Labs:  Pap smear (+) for low grade sqaumous intraepithelial lesion.  HPV (+).  Cervical bx (+).	OTH	OTH	Unknown		None		WAES0811USA01071	1						1	Anogenital warts; Anorexia; Fungal infection; Genital lesion; Gynaecological examination abnormal; Malaise; Papilloma viral infection; Smear cervix abnormal	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~1978U~3~UN~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0332349	11/14/2008	FL				F	11/10/2008	Initial information was received on 03 November 2008 from another manufacturer, document number 45208254, whose initial reporter was a consumer. This report was not medically confirmed. A female patient received the influenza vaccine, reported as the flu vaccine (manufacturer, lot number and date not reported). She developed Bells Palsy four days after receiving the influenza vaccine. Recovery date was not reported. No further information was provided. Documents held by sender: None.				Y									None reported.	UNK	UNK					200803406	1						1	Facial palsy	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0332361	11/14/2008	MD	8.0	8		F	11/12/2008	Onset type I diabetes mellitus  1/7/09 Reviewed hospital records for 10/18-10/22/2008. FINAL DX: new onset type 1 diabetes mellitus; DKA Records reveal patient experienced polyuria, polydipsia, nocturia & weight loss over 6 wk period.  Admitted to PICU on insulin drip for DKA.  Stabilized on sq insulin & d/c to home w/continued diabetes education & management in clinic.			Y	Y	Y	5		Y	Y	09/17/2008	10/18/2008	31	urinalysis: large glucose; blood glucose, 450; large ketones; potassium, 2.5   LABS: CO2 6(L), anion gap 26.  (+)urine ketones.  HgA1c 12.7%(H).  serum IGA 233.	PVT	PVT	No	No	No  PMH: allergic to shellfish.			1						1	Blood glucose increased; Glucose urine; Type 1 diabetes mellitus; Urine analysis abnormal; Urine ketone body present; Urine potassium increased	FLUN3~MEDIMMUNE VACCINES, INC.~500544~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~1000X~2~SC~UN~VARICELLA (VARIVAX)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0332363	11/14/2008	NM	30.0	30		F	11/10/2008	Chest pressure, bilat. palms red, itchy swollen, left side of body heavy and achy. Sx started at - 21:00 10-10-08 at - 16:00 10-11-08 went to an urgent care center.  Per Pt. Dr. told her it was an allergic reaction to the flu vaccine and gave her an injection of DIPHENHYDRAMINE.				Y					Y	10/10/2008	10/10/2008	0	None done	OTH	OTH	none	no	NKDA, Asthma, Anxiety (Per Pt.)			1						1	Chest discomfort; Erythema; Hypersensitivity; Pain; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U2786CA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332364	11/14/2008	NC	43.0	43		F	11/14/2008	Pt presented to clinic for FLUARIX. Asked patient standard info (ie allergies, adverse reactions) Pt responded negative. Gave FLUARIX 15 min later patient back to clinic c/o job, itchy cheeks. Adminstred .3 benedryl, 02, caled. Retrieved vitals, 147/70, 87, bpm, 100%; govl .3 epl ogin. No further incident.				Y					U	11/13/2008	11/13/2008	0		MIL	MIL	UNK	None	Asthma			1						1	Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AKLLA192AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0332365	11/14/2008	CT	50.0	50		F	11/12/2008	C/O pain and decreased mobility of deltoid/shoulder, getting progressively worse since vaccination administered. Onset of pain @ time of vaccination, decreased mobility a few days later. No swelling or ecchymosis @ site. To have appointment evaluated by PCP 11/11/2008. Per follow-up: She was seen by her PCP on 11/11/08 and provided with anti-inflammatory medication. She feels well now.				Y					Y	10/28/2008	10/28/2008	0		PUB	PUB		None	None			1						1	Injected limb mobility decreased; Musculoskeletal pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~892975P~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0332366	11/14/2008	VA				U	10/31/2008	Leaking from the vial stopper of FLUVIRIN lot #89685 after withdrawing second dose. Vial was discarded and 8 doses were wasted.										10/30/2008	10/31/2008	1		UNK	UNK						1						1	Device leakage	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89685~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332368	11/14/2008	MS	24.0	24		F	11/07/2008	Diarrhea, dizziness, diaphoresis, feeling of eyes jerking  began at 130 am approximately 12 hrs after vaccine.				Y					U	11/06/2008	11/07/2008	1	Referred to Emergency Room	PUB	OTH	Senemet, Estrostep, Lexapro, Focalin	None Known	None Known			1						1	Diarrhoea; Dizziness; Eye movement disorder; Hyperhidrosis	FLU3~CSL LIMITED~04549111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|TDAP~SANOFI PASTEUR~62996AA~UNK~IM~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0332369	11/14/2008	MI	26.0	26		F	11/06/2008	Persistent and severe pain L arm with shoulder/deltoid weakness over greater than 2 weeks.				Y					N	10/21/2008	10/22/2008	1	Ultrasound/MRI pending	PVT	PVT	PROZAC; FLEXERIL	None	anxiety; tension headache			1						1	Muscular weakness; Nuclear magnetic resonance imaging; Pain in extremity; Ultrasound scan	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~87923~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0332370	11/14/2008	WI	84.0	84		F	11/10/2008	4cmx4cm red,hot,circular area to PNEUMOVAX injection site fever 101.5				Y					Y	11/06/2008	11/07/2008	1		PVT	UNK	SEE ATTACHED	Leukemia-stable	SEE ATTACHED			1						1	Injection site erythema; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U2752AA~2~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0868X~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332371	11/14/2008	PA	12.0	12		F	10/22/2008	Itchy, erythematous nausea/vomiting/wheezing.  Temperature 100 ER.  Epi loaded.  Patient refused the injection (got better) 1/12/10 follow up ; itchy eyes, throat irritaion,									Y	10/17/2008	10/17/2008	0	None	PUB	UNK		None	Seafood allergies			1						1	Body temperature increased; Erythema; Nausea; Pruritus; Vomiting; Wheezing	FLU3~SANOFI PASTEUR~U27497AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2771AA~4~UN~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1015X~1~UN~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0332372	11/14/2008	MI	48.0	48		M	10/29/2008	Generalized pruritis-1hr-after vaccination-lasted approx. 5hrs until took Benadryl.									Y	10/22/2008	10/22/2008	0		PVT	PVT			Celiac disease			1						1	Pruritus generalised	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA364BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0332373	11/14/2008	IL	18.0	18		M	10/12/2008	Shortly after receiving vaccine, patient looked very pale.  He was still sitting in the chair and lost consciousness for 1-2 seconds.  He regained color immediately and said he felt fine.  He remained on site another 20 minutes to make sure he was okay.  Patient was called 3 hours after incident and reported to be doing great.									Y	10/11/2008	10/11/2008	0		OTH	OTH	None	None	None			1						1	Immediate post-injection reaction; Loss of consciousness; Pallor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~2~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332374	11/14/2008	PA	3.0	3		F	11/06/2008	Acute onset urticaria 4 hours after flu-mist administered.  No dyspnea or dysphagia.  No new exposures otherwise.  Concurrent allergic coryza (patient has history of this).  No medications at time of vaccine.  Patient has received flu-shot previously without reaction.  Suspect urticaria related to flu-mist and will not administer in future.									Y	11/05/2008	11/05/2008	0		PVT	PUB	Apparent allergy to Motrin	None	Allergic coryza; Coloboma (OD) and Strabismus			1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500576P~1~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0332375	11/14/2008	NE	66.0	66		F	11/07/2008	The customer stated that the injection hurt at the time. I rubbed the arm and she had no other complaints - she came in after 3 days and stated she had spoken to her Dr. and he thought I had nicked a nerve.									U	10/31/2008	10/31/2008	0		OTH	OTH	Unknown	Unk	Unk			1						1	Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89BB2~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332376	11/14/2008	VA	76.0	76		F	10/24/2008	Pt experienced itching & redness on the arm vaccine was administered. Not at the administration site but along the forearm. She didn't know if she got poison ivy or if this was a reaction.									Y	10/22/2008	10/22/2008	0		OTH	PUB		None	None			1						1	Injection site erythema; Injection site pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~87950~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332377	11/14/2008	KS	65.0	65		F	11/07/2008	-Erythematous rash @ injection site that's warm 9cm mv x 92cm mv  -strange dreams -very bad headache 8/10				Y					U	11/04/2008	11/04/2008	0		PVT	PVT	LIPITOR; ASA; NORVASC; hydrochlorothiazide; vit C; AMLODIPINE; MOTRIN; Vitalase vit.		Dyslipidemia; Impaired glucose tol.; HTN			1						1	Abnormal dreams; Headache; Injection site erythema; Injection site rash; Injection site warmth	FLU3~CSL LIMITED~01749111A~UNK~UN~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~0742X~1~UN~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~CB027BA~1~UN~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0332378	11/14/2008	PA	25.0	25		F	11/08/2008	Small 1.8cm area of superficia blanching erythema without induration.										11/06/2008	11/08/2008	2		PVT	PVT						1						1	Erythema; Pallor	FLU3~SANOFI PASTEUR~U2747AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332379	11/14/2008	UT	22.0	22		F	10/30/2008	Patient received FLUZONE 0.5 cc . Color good. No distress. reported patient walked with husband across the room, sat down, got up and walked a few steps, then fainted, hitting head on windowsill. Reported feeling nauseous, dizzy, felt hot flash. Nurse reported immediately. Patient stable, blood pressure 110 over 84, temperature 97.3. Aroused with ammonia inhalant. Left forehead abrasion, left knee hit wall. Blood pressure 114 over 88. Paramedics responded and took over care at 11:40.				Y					Y	10/30/2008	10/30/2008	0		OTH	PVT		None				1						1	Body temperature increased; Dizziness; Excoriation; Head injury; Hot flush; Immediate post-injection reaction; Joint injury; Nausea; Syncope	FLU3~SANOFI PASTEUR~U2808AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332380	11/14/2008	TX	69.0	69		F	10/28/2008	Right arm redness and swelling in deltoid area 10/28 patient took BENADRYL and applied ice 10/26, 10/27, 10/28. Dr. appt at 3:30pm 10-28-08.				Y					Y	10/25/2008			Unknown	OTH	PVT		None				1						1	Erythema; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~0989U~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~89881~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332381	11/14/2008	OR	1.8	1	.8	M		11-05-2008 11AM. Child had convulsion and was on way to ED when he stopped breathing-family stopped at fire dept and child was transported to ER supportive care given. Child was given supportive care and discharged home cond. good at 2PM.				Y					Y	11/04/2008	11/05/2008	1		PUB	PUB	NONE					1						1	Convulsion; Respiratory arrest	FLU3~SANOFI PASTEUR~U2806AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C222~3~IM~LA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0332383	11/14/2008	DC	61.0	61		M	11/12/2008	The day after receiving flu shot had tenderness at site which progressed to upper (waste to head) Rt delt to lt side. All upper body aches to point where home sick for a couple days and saw PCP. No fever or other sx just upper bodyaches									Y	10/31/2008			None	OTH	PUB	LIPITOR; ALTACE; LOPRESSOR; PLAVAX	None	shellfish all; Non dx strep infec			1						1	Injection site pain; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA316BA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0332384	11/14/2008	MO	61.0	61		F	11/10/2008	2:00 pm Chest tightening, achy all (Friday) over, dry cough and chills. Saturday morning doing fine, tired									Y	11/07/2008	11/07/2008	0		OTH	UNK	HCTZ Hydroclorathizine 50 mg	None	asthma			1						1	Chest discomfort; Chills; Cough; Fatigue; Pain	FLU3~SANOFI PASTEUR~U2769AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332386	11/14/2008	MN	1.0	1	.0	M		8 pm irritability, crying, didn't sleep, up all night.  10 am mild rash on trunk, decreased appetite.  Normal HEENT, MUG, HRT, Abd exam.									N	11/06/2008	11/06/2008	0	T - 99.8, five reticular rash on trunk, small 1-3 mm dia erythema around all 4 shot sites on thighs, largest left lower injection site.	PVT	PUB	None	None	Macrocephaly; Cardiac murmur - undiagnosed			1						1	Body temperature increased; Crying; Decreased appetite; Injection site erythema; Irritability; Rash; Sleep disorder	FLU3~SANOFI PASTEUR~UT2788HA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HBHEPB~MERCK & CO. INC.~0537U~2~IM~RL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0183U~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C65047~4~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0332387	11/14/2008	MA	1.3			M	11/05/2008	Localized redness upper lateral thigh, mild tenderness low				Y										UNK	UNK						1						1	Erythema; Tenderness	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~~UNK~UN~UN~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0332388	11/14/2008	MA	10.0	10		M	11/07/2008	Patient given Influenza vaccine Flulaval instead Influenza vaccine Fluzone.									Y	11/03/2008			None	PVT	PVT	None					1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA181AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332389	11/14/2008	MA	10.0	10		M	11/07/2008	Influenza - FLULAVAL given to pt <18 y.o.									Y	11/03/2008			None	PVT	PVT	None		none			1						1	Inappropriate schedule of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA181AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332390	11/14/2008	MA	8.0	8		M	11/07/2008	Influenza vaccine FLULOVAL given to pt < 184.0.									Y	11/03/2008				PVT	PVT	Albuterol, multivit-Fluoride					1						1	Inappropriate schedule of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA18AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0332391	11/14/2008	MA	22.0	22		F	11/07/2008	Immunization DTAP 0.5 mL administered instead of T-DAP 0.5 mL.  No side effects reported.									Y	10/30/2008			None	PVT	PVT	Aviane-28; Proair; Advair					1						1	Wrong drug administered	DTAP~SANOFI PASTEUR~U2354AA~UNK~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2747AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332392	11/14/2008	ME	26.0	26		F	11/17/2008	2.0 cm local reaction.									Y	11/06/2008	11/07/2008	1		OTH	OTH	ASACOL; oral contraceptives; multivitamin	No	No			1						1	Local reaction	FLU3~SANOFI PASTEUR~U2828AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332393	11/14/2008	OK	62.0	62		M	11/14/2008	1 day after - tiredness, aches. 2 days after: fever 101.3, aches, very tired. Fever continued for 4 more days, night sweats. After fever left, began congested coughing. Went to doctor on Nov 12 and diagnosed w/ bronchitis. Have never had a lower resp. illness before in my life. Just wondered if there could be a connection.									Y	10/24/2008	10/25/2008	1		PUB	OTH	NORVASC; PREVACID; atenolol	None	high blood pressure; GERD			1						1	Bronchitis; Cough; Fatigue; Night sweats; Pain; Pyrexia; Upper respiratory tract congestion	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332396	11/14/2008	MI	73.0	73		F	11/12/2008	Patient called to report 24 hours after receiving flu shot in left deltoid, pain in injection site radiating down to elbow - back up to shoulder area - unable to lift arm.  Reports 11-10-08 that she had ball and socket replacement of left shoulder 4-08 - No aches or problems till after flu shot - doing ice; Ibuprofen - will consult with doctor if pain doesn't stop.				Y					N	10/24/2008	10/25/2008	1	Shoulder replacement 4-08 - left side.	PUB	UNK	None	None	Arthritis generalized			1						1	Arthralgia; Injected limb mobility decreased; Injection site pain; Musculoskeletal pain; Shoulder arthroplasty	FLU3~SANOFI PASTEUR~U2745AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332403	11/14/2008	CA	57.0	57		F	11/14/2008	Hep B 20 mcg given IM right deltoid.  Pt. immediately c/o feeling pain to right deltoid; became dizzy, vasovagal; BP to 80 HR thready, Pt pale.  Diffuse swelling noted to right deltoid.									Y	11/12/2008	11/12/2008	0	None	PUB	PVT	None	None	Septra, Erythromycin, Dust			1						1	Dizziness; Immediate post-injection reaction; Injection site pain; Injection site swelling; Pallor; Pulse abnormal; Syncope vasovagal	FLU3~SANOFI PASTEUR~C2748AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB659AA~5~IM~RA~HEP B (ENGERIX-B)~1	USA		Influenza
0332404	11/14/2008	NH	59.0	59		F	11/14/2008	Difficulty breathing    TooK two benadryl tablets									Y	11/12/2008	11/12/2008	0		PVT	UNK			pennicillen, sulfur drugs, erthyromycin			1						1	Dyspnoea	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332405	11/14/2008	PA	1.33	1	.4	F	11/14/2008	Left arm swelling and redness									Y	11/10/2008	11/11/2008	1		PVT	PUB						1						1	Erythema; Injection site erythema; Injection site swelling; Oedema peripheral	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B085BA~4~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2788IA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332406	11/14/2008	WV	32.0	32		F	11/14/2008	Severe pain in injection site. Coughing progressed to wheezing and extreme difficulty breathing. Fluid expelled from the lungs. Heart rate elevated.Was given medication and breathing treatments at Hospital ER. Had two more episodes after medication was given.  11/18/08 Reviewed hospital medical records of 11/13/2008. FINAL DX: allergic reaction to flu shot Records reveal patient experienced SOB, wheezing, coughing, nausea, vomiting x 1 day.  In ER was hypertensive, tachycardic w/O2 sat of 86% on RA.  Tx w/antihistamine, steroids, nebs.  Admitted overnight for observation.  Responded well to treatment & d/c to home on continued oral antihistamine, inhaler, antiibotics & steroid taper.				Y	Y	1			Y	09/13/2008	09/13/2008	0		UNK	UNK			PMH: cardiac arrhythmia.  Allergy: PCN, levaquin, vancomycin.			1						1	Cough; Dyspnoea; Heart rate increased; Injection site pain; Wheezing	FLUX~UNKNOWN MANUFACTURER~UN~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0332409	11/14/2008	NH	4.0	4		M	11/14/2008	presented with entire upper arm (shoulder to below elbow) pruritis and edema, erythema, induration, warmth 11/14.  no airway or respiratory symptoms; no systemic rash.  will continue Zyrtec and add Benadryl 25 mg q6h prn & hydrocortisone 1% cream at margins bid prn									Y	11/12/2008	11/13/2008	1	none	UNK	UNK	Zyrtec 10 mg daily	no	allergic rhinitis, Rhus dermatitis			1						1	Injection site erythema; Injection site induration; Injection site oedema; Injection site pruritus; Injection site warmth	FLUX~SANOFI PASTEUR~U2800AA~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332410	11/14/2008	MA		39		M	11/14/2008	Patient seen at ER with fever 102F which started 12hours after she had recieved on the right arm flu shot and tetanus boost shot, on the same day recieved also pneumoccocus shot on left arm. she informed that the fever had increased after take tylenol #3 2 tablets reason to come to the ER + pain and limited ROM on right arm.On exame she had significant swelling of right arm with local erythema well delimitated (area 15 x 15cm), local US showed fluid collection with deepest 0.5cm. NO signs of neuropathy, pulses simmetric.				Y						11/13/2008	11/14/2008	1	US confirms local fluid collection (deepest 0.5cm)	UNK	UNK		s/p D & C (elective pregnancy termination due to chromossomal anomaly)	chronic pain/ fibromyalgia			1						1	Erythema; Injected limb mobility decreased; Oedema peripheral; Pain in extremity; Pyrexia; Ultrasound scan abnormal	DTAP~UNKNOWN MANUFACTURER~~UNK~~RA~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0332411	11/14/2008	MN	51.0	51		M	11/14/2008	Rash on hands and legs; itching.  Swelling to knees started about 3 days after injection.				Y						11/07/2008	11/07/2008	0		UNK	UNK						1						1	Joint swelling; Pruritus; Rash	FLU3~SANOFI PASTEUR~U2791EA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332413	11/14/2008	KS	25.0	25		F	11/14/2008	Patient went to ER 11-12-08 at approximately 11 pm. She was complaining of itching & had hives from her shoulders, down both arms to the elbows, and across her chest area.  Hives did not extend down onto her breasts.  She was treated with 125mg injection of Solu-Medrol & sent home with 2 additional 20mg tablets & a script (RN was unable to recall dosages written on script).  She was also advised to purchase some Benadryl over the counter and take as directed.  We saw her back in Employee Health around 0800 on Wednesday, 11-13-08, for new employee orientation.  RN reports patient showed no evidence of hives at that time.				Y					Y	11/12/2008	11/12/2008	0		UNK	UNK	None	None	Allergy to Sulfa			1						1	Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89982~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~MERCK & CO. INC.~0398X~1~IM~RA~HEP B (FOREIGN)~1|UNK~UNKNOWN MANUFACTURER~85858~3~ID~LA~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0332416	11/14/2008	GA	4.0	4		F	11/14/2008	Patient received Fluzone influenza vaccine on 11/12/08 at 10:15 am.  On 11/13/08 patient returned to office with a local reaction on right thigh.  5 cm deep, 5 cm deep , 7 3/4 cm wide.  Deep red color, some tenderness, itching, warm to the touch.				Y					Y	11/12/2008	11/12/2008	0		PVT	PVT	Singulair	No illness or fever				1						1	Injection site erythema; Injection site pain; Injection site pruritus; Injection site warmth; Local reaction	FLU3~SANOFI PASTEUR~U2763AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332418	11/14/2008	MO	44.0	44		F	11/14/2008	Started with headache and soreness at injection site on day of injection.  Next morning aching goes down back, up neck and into shoulders.  Right upper arm slightly swollen, and warm to touch under right arm and deltoid to elbow. Fever this am 99.1									U	11/13/2008	11/13/2008	0		PUB	PUB		None	Hay Fever			1						1	Back pain; Headache; Injection site pain; Musculoskeletal pain; Neck pain; Oedema peripheral; Pyrexia; Skin warm	FLU3~SANOFI PASTEUR~u2765AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1382U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332422	11/14/2008	PA	43.0	43		M	11/14/2008	Anthrax vaccine received right arm and Typhoid received in left arm. Within 72 hours began to note redness, pain and swelling of upper right arm. By day 5 had numbness of all right finger with possible loss of grip stength.									Y	02/09/2008	02/12/2008	3		MIL	MIL	N/A	N/A	N/A			1						1	Asthenia; Hypoaesthesia; Injection site erythema; Injection site pain; Injection site swelling; Pain in extremity	ANTH~UNKNOWN MANUFACTURER~~UNK~~~ANTHRAX (NO BRAND NAME)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500502P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TYP~SANOFI PASTEUR~A0394~3~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0332424	11/14/2008	PA	41.0	41		F	11/14/2008	Patient received influenza vaccine on 10/3/08.  Reported that about 2 or 3 days later, developed cough and sinusitis.  Symptoms resolved in slightly over 1 week.									Y	10/03/2008	10/05/2008	2	N/A	UNK	UNK	unknown	none	none			1						1	Cough; Sinusitis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~GSK AFLLA174AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332426	11/14/2008	NJ				F	11/14/2008	Shoulder Pain				Y						10/22/2008				UNK	PVT						1						1	Musculoskeletal pain	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332427	11/14/2008	PA	52.0	51		F	11/14/2008	Patient received influenza vaccine on 10/1/08.  15 minutes after the injection, patient reported her lip went numb and her jaw went numb.  Vitals were checked and were WNL.  Symptoms resolved.									Y	10/01/2008	10/01/2008	0	Vitals on 10/1/08 WNL	UNK	UNK	unknown	none	unknown			1						1	Hypoaesthesia; Hypoaesthesia oral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~GSKAFLLA174AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332429	11/14/2008	GA	9.0	9		M	11/14/2008	L deltoid has redness and warm to touch, moves well, no inderation				Y					Y	11/12/2008	11/13/2008	1		PVT	PVT	Ibuprofen					1						1	Erythema; Skin warm	FLU3~SANOFI PASTEUR~U2763AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332430	11/14/2008	IL	0.5	0	.5	M	11/14/2008	GRANDMA ( LEGAL GUARDIAN) NOTED 3 LARGE HIVES ON HIS RIGHT THIGH, APPROXIMATELY ON 8:30 P.M. ON NOV 13 08, THESE SYMPTONS HAVE NOT GOTTEN ANY WORSE, NO SOB, DR. NOTIFED.									Y	11/13/2008	11/13/2008	0		PUB	PUB						1						1	Injection site urticaria	DTAPIPVHIB~SANOFI PASTEUR~C3177AA~2~IM~RL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~UT2787DA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0725X~4~IM~LL~HEP B (RECOMBIVAX HB)~1|PNC~PFIZER\WYETH~D01075~4~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0332431	11/14/2008	GA	6.0	6		M	11/14/2008	Large red area on L deltoid, no induration				Y					Y	11/12/2008	11/14/2008	2		PVT	PVT		No illness				1						1	Erythema	FLU3~SANOFI PASTEUR~U2763AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332435	11/14/2008	PA	2.0	2	.1	M	11/14/2008	Right deltoid redness, pain and swelling									Y	11/11/2008	11/12/2008	1		PVT	PUB						1						1	Injection site erythema; Injection site pain; Injection site swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B085BA~4~IM~RA~DTAP (INFANRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500548P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB259AA~1~IM~LA~HEP A (HAVRIX)~1	USA		Influenza
0332437	11/14/2008	GA	10.0	10		F	11/14/2008	LATERAL ASPECT OF RIGHT ARM WITH 4.8 X 5 CM AREA INFLAMED WITH ERYTHEMA , INDURATED									Y	11/12/2008	11/13/2008	1		PVT	PVT		NONE	ECZEMA, RAD			1						1	Erythema; Induration; Inflammation	FLU3~SANOFI PASTEUR~U2847AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1000X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0332438	11/14/2008	MO	23.0	23		M	11/14/2008	Pt states:  two days post Flu Mist he has sharp chest pain and was short of breath.  Seen in ER and was diagnosed with myocarditis.  Pt treated in hospital and was told to follow up with his Dr.  4/23/09 Received hospital medical records of 4/14-4/18/2008 & 10/20-10/21/2008. FINAL DX: myopericarditis; hypothyroidism Records reveal patient experienced chest pain, SOB, fever, chills, generalized weakness, fatigue & body aches x 1 day.  Admit temp 101.1.  Slowly improved but still had episodes of tachycardia, dyspnea & pleuritic chest pain intermittently w/activity.  D/C to home on continued NSAID w/cardio f/u.    Patient readmitted 10/20-10/21/2008. FINAL DX: retroperitoneal hematoma; hypothyroidism; mild pericarditis. Records reveal patient developed right groin pain which progressively worsened & moved from right groin into abdominal RLQ.  Improved & d/c to home.  3/19/09 Received multiple ER visits:  10/14/2008 ER visit: FINAL DX: endocarditis vs myocarditis, viral syndrome & chest pain Records reveal patient experienced myalgias & fevers, chest pain, SOB x 3 days.  Transferred to higher level of care for cardiac cath.  10/19/2008 ER visit: FINAL DX: right retroperitoneal hematoma s/p cardiac cath; s/p myocarditis Records reveal patient experienced abdominal pain, nausea, right groin swelling where catheter inserted.  Transferred to higher level of care.  11/12/2008 Outpatient PFT testing which was WNL.  12/1/2008 ER visit: FINAL DX: pleurisy Records reveal patient experienced chest pain x 1 day.  Tx w/NSAIDS & rest. D/C to home.				Y	Y	7			Y	10/08/2008	10/10/2008	2	4/14-4/18/08 LABS: EKG w/diffuse ST-T wave changes c/w myopericarditis.  Troponin 8.55(H), CK-MB 34.2(H, )D-dimer 912(H).  Lipid studies WNL.  Fibrinogen 428(H).  CBC & metabolic panel WNL.  Echocardiogram WNL.  Coronary angiogram abnormal.  CT angiogram WNL.  Blood c/s neg.  ER LABS: Troponin 1.41(H).  D-dimer 912(H).  CBC: lymphs 12.1%(L).  BMP WNL.  EKG abnormal .  CXR & CT chest neg.  10/20-10/21/2008 LABS: CT scan & US c/w retroperitoneal hematoma.  LABS:  H/H 12.8/34.8(L).    12/1/2008 ER LABS: CXR & EKG WNL.  H/H 15.4/40.6(L). Troponin WNL.	MIL	MIL	N/A	None	None  PMH:hypothyroidism.			1						1	Chest pain; Dyspnoea	FLUN3~MEDIMMUNE VACCINES, INC.~500557P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0332441	11/14/2008	CA	51.0	51		F	11/14/2008	Employee received a flu vaccine and 2 hours later developed ocular rosacea. Symptoms included dry itchy eyes, red and swollen eye lids. Symptoms resolved after 4 days.  No treatment provided.									Y	10/23/2008	10/23/2008	0		UNK	UNK			Rosacea (non-ocular).  Allergic to PCN			1						1	Conjunctivitis; Dry eye; Eye pruritus; Eyelid oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA357BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0332442	11/14/2008	CA	49.0	49		F	11/14/2008	Received flu vaccine, a few hours later developed dry itchy eyes - lasting 48 hours.  No treatment needed									Y	10/21/2008	10/21/2008	0	None	PUB	PVT			History of Rosacea (non-occular).  Allergic to PCN			1						1	Dry eye; Eye pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA357BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0332444	11/14/2008	FL	38.0	38		F	11/14/2008	Patient had severe itching, redness at site, Redness of both arms, hands, neck and face. Hives present.  C/o of mild nausea and dizziness.  Was placed supine on exam table and had mild SOB. Was given epinephrine pen 0.3mg/ 911 called due to sob. Paramedics evaluated, pt declined going to ER. Denied any further SOB. No acute distress. Took OTC Benadryl 50mg. Kept on site for  20 minutes. Parents present and driving. Left in stable condition.									Y	11/14/2008	11/14/2008	0	None	UNK	UNK		None	After incident pt did report hx of asthma.			1						1	Dizziness; Dyspnoea; Erythema; Injection site erythema; Injection site pruritus; Nausea; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA166AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332445	11/14/2008	CA	4.0	4		F	11/14/2008	MILD TENDERNESS,LOW GRADE TEMP.									U	10/07/2008	10/07/2008	0		PUB	PUB	NONE	NONE	NONE			1						1	Body temperature increased; Injection site pain	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B163BC~4~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2748AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C05379~4~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0332473	11/14/2008	VA	1.0	1	.0	M	11/14/2008	Idiopathic thrombocytopenia Purpura   12/2/08 Reviewed hospital medical records of 11/13-11/15/2008 & 11/17-11/19/2008. FINAL DX: idiopathic thrombocytopenic purpura Records reveal patient experienced bruising & full body petechiae.  Har URI s/s x 2 days & gastroenteritis 10 days prior.  Seen by PCP, CBC revealed thrombocytopenia & admitted.  Tx w/Win Rho.  Improved & d/c to home w/serial labs by PCP.  Seen in Heme/Onc clinic 11/17 & readmitted for plts 15K.  Tx w/IVIG x 2.  Plts improved to 46K & d/c to home w/clinic f/u.				Y	Y	6			Y	10/20/2008	11/13/2008	24	Platelet count=1000; petechiae on exam  LABS: plts 46K at d/c.	PVT	PVT	None	Gastroenteritis 2 weeks earlier	None   PMH: c-section, FT, shoulder dystocia, hyperbilirubinemia, phototherapy.			1						1	Idiopathic thrombocytopenic purpura; Platelet count decreased	FLU3~SANOFI PASTEUR~U2755AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1011X~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1013X~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0332474	11/14/2008	MD	36.0	36		F	11/14/2008	Pain at site followed by paresthesia of arm and lip. No confirmed weakness. Abnormal nerve cond. R arm. 11/17/08 MR received for DOS 11/5-6/2008 with no specific dx.  Pt presented with c/o numbness and tingling of L sided extremities, face and lips R>L x 4 days.  Similar episode in 2001 with (-) w/u. Some dizziness and H/A.  Neuro consult PE (+) for give-way weakness on the L side and (-) sensation to pinprick and temp bilat.					Y	2			N	10/30/2008	11/02/2008	3	MRI/brain/spine; CT brain; MRA; nerve conduct; EMG; EKG; lumbar top Labs and Diagnostics:  CBC and Chem WNL. CXR WNL. CT head WNL. MRI/MRA brain WNL. MRA neck WNL.  MRI Thoracic/Lumbar/Cervical -spine (+) for degenerative changes. Echo (+) for mild mitral regurg.  Lyme (-). CSF WNL.	OTH	OTH		None	PMH:  depression, anxiety, neurosis, UTI, intrarenal stone, IBD. Hysterectomy, C-sec. tonsillectomy.  Allergies to PCN, Demerol, Tylox, Sudafed			1						1	Electrocardiogram; Electromyogram; Injection site pain; Lumbar puncture; Nerve conduction studies abnormal; Paraesthesia; Paraesthesia oral; Scan brain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA388BA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0332476	11/14/2008	IL	1.25	1	.2	F	11/14/2008	Febrile seizure reported by Medical Center ER 18 hours after DTAP/PREVNAR/FLUZONE given				Y					Y	11/13/2008	11/14/2008	1	CBC/UA- normal per ER report	PUB	PUB		None	None			1						1	Febrile convulsion; Full blood count normal; Urine analysis normal	DTAP~SANOFI PASTEUR~C2950AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT27920A~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~D01075~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0332478	11/14/2008	TX	39.0	39		F	11/14/2008	Bloating, stomach hard, diarrhea, and over all feeling sick.				Y						11/05/2008	11/07/2008	2		OTH	UNK						1						1	Abdominal distension; Diarrhoea; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0332479	11/14/2008	MA	39.0	39		M	11/14/2008	Vaccine given 11/07/2008 (L) deltoid. 11/9 (L) deltoid area cellulitis red. Painful. Keflex and Motrin ordered. 11/10 Keflex d/cd Bactrim ordered. 11/13/2008. No complaints and redness noted.									Y	11/07/2008	11/09/2008	2	Atebrile	PVT	PVT	Procardia; Clonidine, Benadryl, Tylenol, Motrin, Albuterol	None	Allergy-ASA Hx of HTN, Asthma			1						1	Injection site cellulitis; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89982~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0224X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332480	11/14/2008	TX	18.0	18		M	11/13/2008	Patient was given flu shot and felt dizzy for minutes later.  Patient looked pale and always kept talking, never fainted.  Patient drank soda and felt better.									Y	11/13/2008	11/13/2008	0	No tests	PUB	OTH		None	None			1						1	Dizziness; Immediate post-injection reaction; Pallor	FLU3~SANOFI PASTEUR~U2791CA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332483	11/14/2008	IL	33.0	33		M	11/14/2008	Fever 104. Coughing and wheezing and ADVIL									Y	11/11/2008	11/11/2008	0	Future physical and Labs will be done.	PVT	PVT	None	None	None			1						1	Cough; Pyrexia; Wheezing	FLU3~SANOFI PASTEUR~U2769AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332485	11/14/2008	GA	4.0	4		F	11/13/2008	Mom reports redness and swelling in right leg. Mom took child to Dr on 10/31/2008. Started oral antibiotics. Took child to ER on 10/31/2008 and spent 8 hours in ER. 2 doses of IV CLINDAMYCIN. CLINDAMYCIN given. Patient then took 14 days oral CLINDAMYCIN. Mom said child had 6x5 red area on right thigh. Diagnosis of cellulitis per ER doctor per mom.				Y					U	10/29/2008	10/30/2008	1	None	PUB	PUB	None	None	None			1						1	Injection site cellulitis; Injection site erythema; Injection site swelling	DTAP~SANOFI PASTEUR~PMCU2356CA~5~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2790AA~5~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~CA08362~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0841X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0510X~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0332486	11/14/2008	OH	34.0	34		M	11/10/2008	11-5-08  injection approx 1 pm, 6pm low grade fever, chills, 8 pm muscle aches, rigors fever 10:40 took Tylenol fever improved 11-6-2008 2 am fever 104, rigors, dizziness headaches, muscle pain 11-06-08 pm all symptoms resolved > all reported by patient.									Y	11/05/2008	11/05/2008	0	None	PUB	PVT	None listed not known	denies	none listed			1						1	Chills; Dizziness; Headache; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U2755AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332487	11/14/2008	WI	53.0	53		F	11/14/2008	Pt received FLU and PNEUMOVAX vaccine on 10-28-08. On 10-29-08 pt woke up with fever, chills and body aches. No SOB, hives, swelling or itching.									Y	10/28/2008	10/29/2008	1		PVT	PVT	HCTZ, Fluoxetine		HTN			1						1	Chills; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89748~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1132U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332492	11/14/2008	IL	77.0	77		F	11/14/2008	Pain at injection site, upon injection. Pain still present as of 11-14-2008. Patient saw Dr, had x-ray done. Shows arthritis in shoulder joint.									N	10/17/2008	10/17/2008	0		OTH	PVT	Coumadin	None				1						1	Arthritis; Immediate post-injection reaction; Injection site pain; X-ray abnormal	FLU3~SANOFI PASTEUR~U2761AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332493	11/14/2008	TX	50.0	50		F	11/14/2008	rash										11/05/2008	11/05/2008	0		OTH	UNK						1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332499	11/14/2008	OH	12.0	12		F	11/14/2008	Welt, redness, swelling, and pain in injection site. Worse the day after injection. Day 3 had gone down.				Y					Y	11/11/2008	11/12/2008	1		PVT	PUB						1						1	Injection site erythema; Injection site pain; Injection site streaking; Injection site swelling; Injection site urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500553P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~1000X~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0332447	11/15/2008	FL	59.0	59		F	11/15/2008	PAIN AT SITE OF INJECTION RADIATING DOWN LEFT ARM TO THUMB WITH LIGHTHEADEDNESS									Y	10/15/2008	10/15/2008	0		UNK	PVT				ARM PAIN/LIGHTHEADNESS~Influenza (Seasonal) (Fluzone)~0~59.90~In Patient		1						1	Dizziness; Injection site pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2754AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332448	11/15/2008	TN	66.0	0	.0	F	11/15/2008	The shot was administered on October 8, 2008.  Within two days I developed a persistent, hacking, and non-productive cough and both knees started aching.  Over five weeks later I still have a debilitating cough which seems to defy treatment and diagnosis and is worse at night.  I do not respond to any cough suppressant remedies such as cough syrup with codeine, cough drops, benzonatate and azithromycin.  An x-ray was clear.  The knee pain has thankfully lessened.				Y					N	10/08/2008	10/10/2008	2		UNK	UNK			diabetes type I			1						1	Arthralgia; Cough	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0332449	11/15/2008	PA	19.0	19		F	11/15/2008	Patient had severe hives covering 90% of her body on Nov. 13.  She went to Health Services on campus.  Got Benadryl.  By midnight hives were so bad we took her to Hospital.  Given steriods.  Strep test came back negative.				Y					Y	11/08/2008	11/13/2008	5	Strep test	UNK	UNK		None	None			1						1	Streptococcal identification test; Urticaria	FLU3~SANOFI PASTEUR~U2771AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332450	11/15/2008	KY	1.22	1	.2	M	11/15/2008	measles like rash 3 days after vaccination with MMR, varicella, and influenza.  11/24/2008 MR received for DOS 11/14-15/2008 with D/C DX; Vaccine Rash. Pt presented to ER with 3 day hx of maculopapular rash which started on the face and spread to trunk and arms s/p 12 mon shots. PE (+) for mucosal lesions, clear rhinorrhea and maculopapular rash. Pt has been irritable and vomited once.					Y	1			Y	11/10/2008	11/12/2008	2	none, diagnosed by clinical examination. Labs and diagnostics:  CBC with WBC 17.6. Babygram WNL. Throat cx-no strep.	UNK	UNK		mild URI	none. PMH: none. NKDA			1						1	Rash morbilliform	FLU3~SANOFI PASTEUR~UT2797FA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB257AA~UNK~~~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~C52997~UNK~~~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0332451	11/15/2008	MT	34.0	34		M	11/15/2008	Pt. received a flu shot on 11/13/2008 at approx. 1:40pm and then at about between the hours of 2:30pm to 4pm he broke out in dime size hives, very red and itchy. The hives would migrate from front of chest to neck as well as, some on his back. He made an after hrs. phone call to a doctor and was advised to take Benadryl. He was seen by the doctor the next day which advised him to continue with the Benadryl prn-and that he looked like he had a mild rash. Patient still had migrating hives as of 8pm on 11/14 and some light colored hives as of 9am 11/15.				Y					Y	11/13/2008	11/13/2008	0		MIL	OTH	N/A	None	None			1						1	Erythema; Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U2833AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332452	11/15/2008	IN	40.0	40		F	11/15/2008	Right nostral swelled shut around 12:00 pm November 14, 44 hours after flu mist administered.  Area around nose extremely tender.  Runny nose.  Taking Benadryl 50 mg every 8 hours with no improvement.										11/12/2008	11/14/2008	2		UNK	UNK		none	no allergies			1						1	Nasal oedema; Rhinorrhoea; Tenderness	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0332453	11/15/2008	MI	37.0	37		F	11/15/2008	SHORTNESS OF BREATH, CHEST PAIN, RAPID HEART BEAT. 12/15/08 MR received for DOS 11/13-14/2008 with DX:  Chest pain. Pt presented with several week hx of dizziness and h/a, now with substernal chest pain which radiates into the neck, associated with palpitations, SOB and nausea.  VS, EKG, O2 sats, and cardiac enzymes all WNL. Sx improved with nitro. Admitted for further w/u which was (-). 1/28/2010 Intermitten episodes of rapid heart beat.			Y	Y	Y	1			N	10/31/2008	10/31/2008	0	ECHOCARDIOGRAM, XRAYS, BLOODWORK. Labs and diagnostics:  CXR WNL.  head CT WNL.  EKG WNL. Echo WNL. Troponins (-)x3. Stress test (-). CK WNL 32.	UNK	UNK		NONE	NONE. PMH:  PCN allergy, fam hx of CAD, otherwise (-).			1						1	Blood test; Chest pain; Dyspnoea; Heart rate increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8811739~2~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0332454	11/15/2008	NV	37.0	37		M	11/15/2008	PALENESS, WEAKNESS, DIZZINESS FEELS LIKE MY EQUILIBRIUM IS OFF.									U	11/13/2008	11/14/2008	1		UNK	UNK						1						1	Asthenia; Balance disorder; Dizziness; Pallor	FLUX~UNKNOWN MANUFACTURER~~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332455	11/15/2008	WI	39.0	39		F	11/15/2008	Received shot 11/14/08 about 3:30PM.  Started feeling sick about 6:00 PM.  Started coughing quite a bit with a alot of phlegm.  Was wheezing, and had trouble breathing.  Also had dry burning eyes.  Called insurance nurse around 9:30 and she recommended I call the paramedics immediately.  My husband drove me to Hospital where I received an adrenaline shot, a benadryl shot, and prednisone.  I started feeling better about 20 minutes later. Was released from the hospital about an hour after that.				Y					Y	11/14/2008	11/14/2008	0		UNK	UNK		none	none			1						1	Cough; Dry eye; Dyspnoea; Eye irritation; Increased upper airway secretion; Malaise; Wheezing	FLU3~SANOFI PASTEUR~unknown~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332457	11/16/2008	UT	50.0	50		F	11/16/2008	Severe uticaria with angioedema beginning about 30 hours post injection. Sweating followed by rash, itching and facial and oral and throat edema. Treatment with Benedryl 50 mg q 4 hrs, and when no response began Prednisone 24 mg po with tapered dose schedule over 6 days.				Y					Y	11/10/2008	11/11/2008	1		PUB	UNK	Cymbalta, EstroGel, ASA, Hydrochlorthiazide, Synthroid, Tizanidine, Lortab	Mild cold for three days, fever resolved prior to injection	Complex Regional Pain Syndrome r arm, Allergy to Ceclor			1						1	Angioedema; Face oedema; Hyperhidrosis; Oedema mouth; Pharyngeal oedema; Pruritus; Rash; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0332458	11/16/2008	MA	69.0	69		M	11/16/2008	I received both the Influenza and Pneumococcal vacines at the same time on Sat 11/08/2008 at 2:00PM at a store. By Sun 11/09/2008 at 2:00AM I was experiencing an adverse reaction to the vaccine administer in my right arm, I believe that was the pneumococcal vaccine. My right arm was very sore, I had a fever, shortness of breath, weak, unsteady walking, headache. After breakfast on 11/09 at 9:00AM, I lost conciousness and collapsed to the floor. On 11/09 at 11:00AM, I again lost conciosness and collapsed on to the floor injuring cutting my forehead, eye brow, and eye lid. I bruised my right thumb severely, right knee, and left shoulder were injured.				Y					Y	11/08/2008	11/09/2008	1	Doctor visit and BMP blood test on 11/11/2008.	UNK	UNK		None	Being treated for HBP. Medications:hydrochorothiazide 25mg/d,isosorbide 20mg/d, lipitor 40mg/d,metoprolol 25mg/d.			1						1	Adverse reaction; Asthenia; Contusion; Dyspnoea; Fall; Gait disturbance; Headache; Joint injury; Loss of consciousness; Metabolic function test; Pain in extremity; Pyrexia; Skin laceration; Syncope	FLUX~UNKNOWN MANUFACTURER~AFLLA166AA~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~0867X~UNK~~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0332460	11/16/2008	WY	56.0	56		F	11/16/2008	Shoulder pain and arm weakness, treatment at urgent care clinic 11/11/2008?  Included NSAIDs and oral corticosteroid medication per patient. Stated physician recommend MRI if not improved by 11/18/2008.				Y					U	10/16/2008	10/16/2008	0	Unknown	UNK	PVT	None listed per VAR	None listed on VAR form	Pre-Diabetes per VAR			1						1	Asthenia; Musculoskeletal pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89880~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0332461	11/16/2008	MI	69.0	69		F	11/16/2008	Patients arm swole up, bruised and as swelling went down, patient says she has itchiness down below (about 5-6 inches) injection site. Patient says she felt fine except for the swelling and bruising in her arem									Y	11/11/2008	11/11/2008	0		PUB	UNK		nONE				1						1	Contusion; Oedema peripheral; Pruritus	FLU3~SANOFI PASTEUR~U2839AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0867X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332462	11/16/2008	CA	29.0	29		F	11/16/2008	I am an RN in the last year of a nurse practioner program and received the vaccine through student health (I think the student health flu vaccine program is closely associated with employee health). Within 24 hours of receiving the vaccine in  my left deltoid I discovered a 2-3cm round, circumscribed, erythemetous, hot, painful, swollen, raised area of skin reaction at the site of administration. It went from 2 to 4 cm over 48 hours and then slowly began to become more diffuse and less red/painful until it diseappeared after 5-6 days. Anectdotally, 4-5 other patients at the time I called employee health had experienced similar symptoms (one had even received antibiotics to treat suspected cellulitis). Additionally, an employee health provider at Hospital told me she's had a couple of patients with this same reaction, which she reported via VAERS. I have never had an allergic reaction to anything before and I was surprised to see this. Just wanted to share my experience for your tracking purposes. Thanks.									Y	10/15/2008	10/15/2008	0	None.	UNK	UNK	None.	None.	No seasonal, medication or food allergies. No birth defects, medical conditions, chronic health problems, etc.	None~ ()~~0.00~In Patient		1						1	Injection site erythema; Injection site pain; Injection site rash; Injection site swelling; Injection site warmth; No reaction on previous exposure to drug	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0330620	11/17/2008	IL	32.0	32		F	11/17/2008	On Oct 2, 2008 patient was vaccinated with flumist with the standard procedure for intranasal administration, spraying half of the vaccine into the L. nostril and half into the R. nostril. I received this report from the family and I have no reason to doubt its validity: On the 18th she experienced severe ear pain and a bad bad cold which continued all weekend, though Monday the 22nd.  (The 22nd was a Wednesday, so probably the family was referring to the 20th. On the 22nd (sic) at 3AM she was feeding the baby when she realized she couldn't move her lips on the R. and couldn't blink with her R. eye. She went to ER thinking she was having a stroke. The CT was  negative and she was diagnosed with Bell's Palsy.  She was given steroids, which she took. On the (23rd) she took the steroids as directed.  She experienced pain,  loss of appetite, vomiting,  sleeplessness and a twitchy feeling. On the (24th) she spoke with a friend who had had Bell's palsy and received an antiviral medication. The next day (25th) she saw the internist, was given an antiviral medication along with the steroids, and ibuprofen as well.  She was directed to take the antiviral 5 times per day for 10 days.  After 4 doses she started to vomit profusely and had abdominal pain and worsening ear pain.  The pain was debilitating and the Bell's palsy worsened, resulting in diminished eye and facial movement. She stopped the antiviral, and started acupuncture.  Her appetite returned. On the 26th she saw a neurologist and her eye still making tears.   Her exam revealed a lack of taste sensation on the R. side.  The neurologist recommended stopping the antiviral (she had already done this). The doctor said she had a 92% chance of regaining function in her face over time. He told her to stop taking ibuprofen because it was bad for stomach and probably causing the vomiting. He also gave her vicodin for her continued pain, but this did not work. She continued to have sleeplessness, nausea and pain. The pain was severe, and she called her physician in the middle of night.  The physician prescribed Norco, and started this on the 27th.  This was ineffective and she requested Oxycontin but couldn't get a prescription over the phone. She was prescribed Lyrica for long-term pain management on the 28th.  This medication led to profuse vomiting, jitteriness and sleeplessness. As none of the pain medications had worked, she stopped everything but the steroids, although at this point she was finished with her 5-day prescriptions. She then started twice daily acupuncture, after which she was able to eat soup for a bit and could sleep a bit.  She has continued this regimen. She also tried her husband's Xanax (1g) and was able to sleep. On November 17 patient's pain and nausea had diminished albeit with daily acupuncture.  Her only remaining symptoms are vertigo and facial control.				Y					N	10/02/2008				UNK	UNK		Post-partum, with 4 month old infant.				1						2	Ageusia; Ear pain; Facial palsy; Inflammation; Neurological examination abnormal; Nuclear magnetic resonance imaging; Pain in jaw; Abdominal pain; Ageusia; Anorexia; Computerised tomogram normal; Ear pain; Facial palsy; Hyporeflexia; Insomnia; Lacrimation increased; Muscle twitching; Nasopharyngitis; Nausea; Pain; Vertigo; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500547P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500547P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Emergency room visit	Influenza
0332232	11/17/2008	NJ	52.0	52		F	11/15/2008	Patient complain of left upper arm(shoulder to elbow). With difficulty moving arm due to pain. Stated better today. Advised to call primary doctor.									N	10/21/2008	10/21/2008	0	None	UNK	UNK	None	None	None			1						3	Pain in extremity; Injected limb mobility decreased; Pain in extremity; Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2787EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U27870~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~U27870~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA		Influenza
0332233	11/17/2008	NJ	52.0	52		F		Pt c/o sharp pain (L) upper arm immediately upon receiving injection . Saw PMD. Referred to Orthopedist. On pain med Tramadol.									N	10/21/2008	10/21/2008	0	None	UNK	UNK	LEVOXYL, CYMBALTA	None	Hypothyroid, anxiety			1						2	Pain in extremity; Immediate post-injection reaction; Injection site pain	FLU3~SANOFI PASTEUR~U2787EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2787EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0332505	11/17/2008	GA	68.0	68		F	11/04/2008	On Thurs. 10/24 got FLUVIRIN @ 3pm. By 4:00 -4:15 Eye swelling, itching also palms of hand, awake all night itching all over body.  As the day went on I started swelling with red welts over my body I called pharmacist and he said to take benedryl which I did. I didn't sleep any, Thursday night I called 911 and had to go by ambulance to the emergency room where they gave medinigsone. Friday Am my husband drove me to the emergency as my B.P. Was high. they put more steroids into me and saw if my mouth started swelling to come back. My mouth was 3-4 times bigger. By Saturday I wasn't able to get out of bed. My B/P dropped by time paramedics got their I was going into shock.  I had FLUVIRIN year arm not allergies to eggs Prednizione has so many effects on me also. I've had terrible experience with this I would NEVER take another shot and would advise anyone that Flu wouldn't be as bad as this has has been. I have Medicare and blue cross secondary ins. I didn't know if they will pay, however if they don't I will be back in in forth with you. Fri AM face, eyes swelled shut call 911 went to emergency got shot, went home. Mouth swelling back to hospital on Sat. B/P dropped 53, going into shock back to hospital stayed overnight 10/25/2008 form attached from hospital.  11/18/08 Reviewed ER records that accompanied report. FINAL DX: allergic reaction to influenza vaccine. Records reveal patient seen in ER on 10/24/08 & again on 10/25-26/2008.  Tx w/steroids, antihistamine initially, released to home & returned next day.  Admitted overnight for observation.  D/c to home on continued steroids & antihistamine.				Y	Y	1			N	10/23/2008	10/23/2008	0	On Sat. B/P dropped 53, going into shock back to hospital stayed overnite 10/25/08	UNK	UNK	CARDIA XT- PREMARIN - 325 MG; ACIPHEX- 10; LEXAPRO 20; XANAX .5	High B/P	Brain bleed- 2-07-07			1						1	Blood pressure fluctuation; Erythema; Eye swelling; Insomnia; Oedema mouth; Pruritus generalised; Shock; Swelling face; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89970~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0332510	11/17/2008	IA	40.0	40		F	11/17/2008	Flu booster agency gave free flu shots to workers and spouse. Pt is the spouse-she received flu immunization 11-12-08 8am- pt had 2 inch hot, red swollen area (L) deltoid-pt. saw her own Dr 11-14-08- supportive rare only				Y					Y	11/12/2008	11/14/2008	2	None	OTH	PVT	None				IA080818	1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8812602~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0332512	11/17/2008	FL	53.0	53		F	11/10/2008	2 days after received the vaccines, She expressed (high fever, 102, 103 F, then slightly lower the next week. She was unable to get out of bed without, feeling terribly nauseated. She was continued to her bed all week. She was urged to go to the ER but she did not, saw her PCP next day who affirmed adverse reaction.				Y					Y	10/31/2008	11/02/2008	2		OTH	OTH	IMITREX; XANAX; FIORCET; TYLENOL #3	None	allergic to DARVON; Hx Migraines			1						1	Activities of daily living impaired; Adverse reaction; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~U2847AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332513	11/17/2008	TX	63.0	63		F		After getting FLUZONE in my left shoulder area (deltoid) and really hurting my upper arm remains sore, particularly when I rotate it or move and rotate it in a certain positions. It is not red swollen or sore to the touch, only when it is rotated.				Y					N	10/20/2008	10/20/2008	0		PVT	UNK		None	I am an allergic person	Hip and tailbone hurt, continued to hurt for 1 to 2 years.~Measles (no brand name)~~0.00~In Patient		1						1	Injected limb mobility decreased; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0332514	11/17/2008	CO	69.0	69		F	10/02/2008	Pt describes hard swelling et pain to (L) deltoid after receiving PNEUMOVAX. Reports a similar response to first dose. Pt has Hx of double mastectomy with lymphectomy in 1989.									U	10/01/2008	10/01/2008	0		PUB	UNK	Methotrexate once/wk, PROTONIX once daily, DIFLUCAN, folic acid, rela	None	Rheumatoid arthritis, Hx breast cancer.			1						1	Injection site induration; Injection site pain; Injection site swelling; Similar reaction on previous exposure to drug; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U2768AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0813X~2~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332515	11/17/2008	CO	58.0	58		F	10/29/2008	Hot shooting pains to (R) upper extremity 15 mins after vaccine, pain and but lasted >1 wk. Temp increased to 101.4 24 hrs after vaccination, decreased to 100 at 48 hrs-controlled with ibuprofen or TYLENOL. Localized inflammation x 6 days, Tests for influenza, UTI negative. Ears no s/s infection. Missed work x 1 day.				Y					Y	10/21/2008	10/21/2008	0	rapid flu negative per pt; urinalysis negative per pt	PUB	UNK	METFORMIN; glipizide; ATENOLOL; LISINOPRIL; lisinopril; ASA; ZYRTEC; MUSENEX	None	Type 2 D. Mellitus, some arthritis to (R) shoulder.			1						1	Body temperature increased; Inflammation; Influenza serology negative; Pain; Urine analysis normal	FLU3~SANOFI PASTEUR~U2804AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0978X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332516	11/17/2008	NJ	49.0	49		F	11/10/2008	Dr made by patient for PHN to observe site of FLUZONE injection(L) Deltoid- 2 from top - hematoma size of 25 cents-piece - black and blue on edge and white in the middle- welt on appearance,  the protrus then became inverted the next day. Tenderness at site. 11/2/08 - Flu vaccine, patient no area of redness, no pain. Still has bruise but is resolving.									N	11/07/2008	11/08/2008	1	None	PUB	PUB	None	None	None			1						1	Contusion; Injection site haematoma; Injection site pain; Skin discolouration; Urticaria	FLU3~SANOFI PASTEUR~U2769AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332519	11/17/2008	OR	13.0	13		F	11/10/2008	Patient was given TWINRIX, instead of correct dosage for age. Misadministration.									Y	11/04/2008				PUB	PUB	None		None		0R200842	1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~U2807AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB08AC~4~UN~LA~HEP A + HEP B (TWINRIX)~1|HPV4~MERCK & CO. INC.~0570X~1~UN~RA~HPV (GARDASIL)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52802AA~1~UN~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0332520	11/17/2008	VA	39.0	39		M	11/11/2008	Complained of scratchy, tight throat (need to keep clearing throat, 4 hrs post vaccine administration 25 mg BENADRYL  Po. - GI problems with 102 degree Temp - Po. - perspired profusely with chills for  12 hrs									Y	11/07/2008	11/07/2008	0		PUB	UNK						1						1	Abdominal discomfort; Body temperature increased; Chills; Hyperhidrosis; Throat irritation; Throat tightness	FLU3~SANOFI PASTEUR~U2804AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332523	11/17/2008	WA	17.0	17		M	11/07/2008	FLUMISt and MENACTRA administered 10/31/08. Sore arm 11/1, mild body aches 11/2, in bed with  severe body aches 11/3 -11/6. No fever/UBI/GI Sx normal exam 11/7/08									N	10/31/2008	11/01/2008	1	None	PVT	PVT			Amoxicillin allergy			1						1	Pain; Pain in extremity	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0332525	11/17/2008	UT	76.0	76		F	11/13/2008	This report was received from a health care professional on 03 November 2008. Seriousness Criteria: Other-Medically Significant. A 76-year-old female patient, with no reported medical history and no illness at time of vaccination, received an intramuscular left deltoid injection of FLUZONE SV (lot number not reported) on 28 October 2008. Concomitant medication included Actonel. On 31 October 2008 she awoke with diplopia and paresthesia of the left hand. An exam revealed limited tracking in the left eye, with no other symptoms. She was scheduled to see an opthamologist on 04 November 2008. Outcome was not reported. Documents held by sender: None.				Y						10/28/2008	10/31/2008	3		PUB	UNK	ACTONEL		No known allergies, no illness at time of vaccination.		200803415	1						1	Diplopia; Paraesthesia; Visual tracking test abnormal	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332526	11/17/2008	OH	3.0	3		M	11/13/2008	This case was received from a consumer (the patient's grandmother) on 03 November 2008. Seriousness Criteria: Other-Medically Significant. A three-year-old male patient received an injection of FLUZONE SV '2005-'2006 USP (lot number U1747AA) on 28 October 2005. On 05 November 2005, approximately eight days after vaccination, the patient developed paralysis of the left leg and mouth. According to the reporter, the patient was seen by neurologists and other specialists, and underwent numerous scans and tests, but no diagnosis was given (test results and treatment were not reported). He also developed ADHD and ticks, which were reported as ongoing. By April 2006 the patient was walking and eating by mouth again. Of note, the patient was discovered to have only one kidney in March 2006, which had been causing hypertension per the reporter. He received FLUZONE SV '2008-2009' on 28 October 2008; at the time of the report, no adverse events had been noted.  1/15/09 Received medical records as part of follow-up. Office visit 11/7/2005 states pt limping & no weight bearing left leg for 3 days.  Received fluzone 01747AA in left arm on 11/7/05.   RTC 11/8/2005 & referred.  1/15/09 Received medical records as part of follow-up. Office visit 11/7/2005 states pt limping & no weight bearing left leg for 3 days.  Received fluzone 01747AA in left arm on 11/7/05.   RTC 11/8/2005 & referred.				Y					N	10/28/2005	11/05/2005	8		UNK	UNK		limping & no weightbearing left leg for 3 days prior to vaccine	In March 2006 it was discovered that the patient only had one kidney, which was causing hypertension.		200803426	1						1	Attention deficit/hyperactivity disorder; Facial palsy; Monoplegia; Tic	FLU3~SANOFI PASTEUR~01747AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332527	11/17/2008	NY	18.0	18		F	11/11/2008	Within 24 hrs of getting FLUZONE vaccine, student unable to comfortably move arm, has discomfort from  (L) axillary to (L) elbow. Some redness at site									Y	10/20/2008	10/21/2008	1		OTH	PVT						1						1	Axillary pain; Injected limb mobility decreased; Injection site discomfort; Injection site erythema	FLU3~SANOFI PASTEUR~U2807AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332528	11/17/2008	PA				F	11/13/2008	Initial report received on 24 October 2008 from a consumer. A female patient (demographics not provided) had received a dose of Influenza vaccine on an unspecified date. The trade name, manufacturer name, route and site of administration of the flu vaccine was not provided. The patient reported that she thinks she might be developing Bell's Palsy after receiving the flu shot. It was not reported whether the patient had any concurrent illnesses, or past medical history at the time of the Influenza vaccination. The patient was subsequently evaluated by a physician; however the outcome of the physician evaluation was not provided. It was not reported whether any relevant diagnostic testings had been completed. The recovery status of the patient was not reported. Follow-up information received on 03 November 2008 from a physician. Per the reporter, the female patient had received vaccination with FLUZONE SV 2008-2009 (date of vaccination, lot number, route and site of administration were not provided) approximately one week prior to this report, which would make the vaccine administration date some time in October 2008. The patient was anxious about receiving the vaccination since she had never received a flu shot before. Approximately a day or two following the vaccination, the patient stated she did not feel well and believed she received Bell's Palsy from the vaccine. The facility where the patient was vaccinated is awaiting a complete diagnosis from the patient's family physician. The nurse at the facility where the patient had received the vaccination will stay in touch with the manufacturer and will ensure all proper VAERS forms and paperwork is completed. Documents held by sender: None.				Y					U	10/01/2008	10/02/2008	1	Not reported	OTH	OTH			Not reported		200803427	1						1	Malaise	FLU3~SANOFI PASTEUR~~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332529	11/17/2008	OR	39.0	39		F	11/06/2008	(L) deltoid with small induration, redness at vaccine site supraclancular edema, tender, mobile (L) supraclavicular node with axillary or cervical nodes.				Y					Y	11/03/2008	11/03/2008	0	none	PVT	UNK	None	Borderline HTN	Syndrome X; Obesity; NKDA			1						1	Injection site erythema; Injection site induration; Lymph node pain; Oedema	FLU3~SANOFI PASTEUR~U2804AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2936BA~1~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0332532	11/17/2008	IA	27.0	27		M	11/13/2008	Initial report received on 04 November 2008 from a consumer who was the patient's spouse. A healthy 27-year-old male patient, with no concurrent illnesses or past medical history, had received a intramuscular left deltoid injection of FLUZONE SV 2008-2009 on 29 October 2008. Four days later (02 November 2008), the patient began itching his scalp, face and axillary area and noticed red, raised bumps in that area. The rash (also referred to as hives) persisted and became widespread over the whole body. The patient self medicated with BENADRYL. The hives would come and go, but did not completely subside. The patient was evaluated by a physician (date not provided) who prescribed prednisone (route not provided). No relevant diagnostic tests or laboratory data were performed or collected. At the time of this report, the patient had not recovered, as the hives were still present and widespread over the whole body. Documents held by sender: none.				Y					N	10/29/2008	11/02/2008	4	None	OTH	OTH			The patient had no concurrent illnesses, pre-existing medical conditions, or use of other medications at the time of the vaccination on 29 October 2008. He had not experienced any adverse events with prior vaccinations; and had not received any other vaccinations within four weeks of 29 October 2008.		200803459	1						1	Erythema; Pruritus; Rash generalised; Urticaria	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332533	11/17/2008	MN	64.0	64		F	11/13/2008	Initial information was received on 04 November 2008 from a health care professional. A 64 year old female patient with a history of COPD (chronic obstructive pulmonary disease), smoker, hypertension, hyperlipidemia, depression, acid peptic syndrome, glaucoma, restless leg syndrome, cerebral vascular disease, migraines, colon polyp, lactose intolerance, sleep apnea, malasia, nasal allergies, and allergies to sulfa, tenormin, methylprednisol, niacin, and lovastatin. On 24 October 2008 the patient received an intramuscular left deltoid injection of FLUZONE SV 2008-2009 (lot number U2740AA). The patient reported achiness after previous flu vaccines. On 24 October 2008 within hours after vaccination the patient reported general achiness, chills, vertigo, headache, sinus drainage, breast bone hurt and her breathing was affected. The patient's oxygen saturation was 85%. The patient was sent to the emergency room and hospitalized overnight. The patient's symptoms had resolved by 31 October 2008. List of Documents held by Sender: None.					Y	1			Y	10/24/2008	10/24/2008	0	The patient's oxygen saturation was 85%.	PVT	UNK	ASA; PLAVIX; OMEPRAZOLE; RANITIDINE; ADVAIR; FLONASE; TRIAMETERENE; HYDROCHLOROTHIAZIDE; KCL; CLONZEPAM; METHYLDOPA; ALBUTEROL; CLARITIN; LIPITOR; NITRO; AZOPT 1%; ALPHAGAN 15%		The patient reported achiness after receiving flu vaccines in the past (manufacturer not reported) and had history of COPD (chronic obstructive pulmonary disease), smoker, hypertension, hyperlipidemia, depression, acid peptic syndrome, glaucoma, restless leg syndrome, cerebral vascular disease, migraines, colon polyp, lactose intolerance, sleep apnea, malasia, nasal allergies, and allergies to sulfa, tenormin, methylprednisol, niacin, and lovastatin.		200803488	1						1	Chills; Dyspnoea; Headache; Non-cardiac chest pain; Oxygen saturation decreased; Pain; Paranasal sinus hypersecretion; Vertigo	FLU3~SANOFI PASTEUR~U2740A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0332543	11/17/2008	PA	27.0	27		M	11/14/2008	FLUVIRIN shot given 10/16/08 at 9:45 am. Pain in left arm started 10/16/08 at 6:00 pm sharp pain in left arm muscle has continued only with certain movements, e.g. when arm is lifted above his head or put behind. No other problems									N	10/16/2008	10/16/2008	0		PUB	PUB	None	None	Asthma and acid reflux			1						1	Injected limb mobility decreased; Myalgia; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88805~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332544	11/17/2008	NJ	47.0	47		F	11/13/2008	Immediately after vaccinated, felt weak, dizzy, and nausea's. Symptoms persisted throughout the day and worsened next day to generalized weakness requiring assistance to walk.				Y					Y	10/01/2008	10/02/2008	1	IVF's given on day 2 for dehydration.	PUB	OTH		None				1						1	Asthenia; Dehydration; Dizziness; Gait disturbance; Immediate post-injection reaction; Nausea	FLU3~SANOFI PASTEUR~U2795DA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332545	11/17/2008	MI	68.0	68		F	10/20/2008	Approx 30 hrs after receiving vaccines client noticed erythema & felt slight tenderness at left deltoid.  At 48 hrs following injections she noticed increased erythema & tenderness & discomfort when arm was moved.  Erythema was spreading into axillary area.  10/17/08 clt seen by physician who presented antihistamine, generic KEFLEX & dose pack of CORTISONE.  Client started meds immediately; has 2 more days, no signs/symptoms remain.				Y					Y	10/13/2008	10/16/2008	3		PUB	UNK	LIPITOR; SYNTHROID; VOLTAREN;  PAXIL; PREVACID-LIKE GENERIC		Elevated cholesterol, Hypothyroidism, Reflux, Osteroarthritis		MI2008027	1						1	Injection site discomfort; Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U2766AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0989U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332546	11/17/2008	NJ	52.0	52		M	11/12/2008	Stated had localized discomfort, right deltoid area 1-2 days after injection. Had increased pain and tingling and some arm immobility after dog on leash pulled arm, is seeing chiropractor. Is still in pain.									U	10/21/2008	10/23/2008	2	None	OTH	UNK	NEXIUM; LOMOTIL; CHOLESTYRAMINE	None	Chest pain; Irritable bowel			1						1	Discomfort; Local reaction; Mobility decreased; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U2787EA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332548	11/17/2008	IL	11.0	11		F	11/14/2008	Pt rec'd 3 vaccines in R deltoid, MONACTRA. GARDASIL, VARIVAX. Within 3 seconds of given GARDASIL, dime size were formed with reddened swollen area 3 by 2. Dr. evaluated and given BENADRYL 25 MG p.o. per Dr. Called mom @ 5:20 pm. She stated it looked less white in center, still swollen.									U	11/14/2008	11/14/2008	0		PVT	PVT		None	Peanuts; Shellfish; Insect bites			1						1	Erythema; Swelling; Urticaria	FLU3~SANOFI PASTEUR~02829AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVR319AA~3~IM~LA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~19680~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~02656AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~2863AA~2~IM~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1181x4037X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0332549	11/17/2008	PA	26.0	26		F	11/10/2008	Erythema, warmth, swelling , pain, itching										11/07/2008	11/08/2008	1		PVT	UNK	Ortho Tri-Cyclen-Lo	None	None			1						1	Erythema; Pain; Pruritus; Skin warm; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332552	11/17/2008	CA	4.0			F		Local reaction to vaccines. Cellulitis right deltoid area. Tx: Ibuprofen 100/s mL 1 1/2 tsp po q 6 hours rn on full stomach. Warm compress.									U					PVT	OTH		4 yr. physical	NKDA			1						1	Cellulitis; Injection site cellulitis; Local reaction	DTAP~SANOFI PASTEUR~2955BA~UNK~IM~RA~DTAP (DAPTACEL)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89620~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~0805~UNK~IM~RA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0332553	11/17/2008	MO	72.0	72		F	11/10/2008	None stated				Y					Y	10/04/2008	10/04/2008	0	None	OTH	UNK		sore arm radiating from shoulder to thumb since injection on 10-04-08				1						1	Musculoskeletal pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0332554	11/17/2008	RI	7.0	7		M	11/13/2008	Generalized tonic clonic seizure for 6-7 hrs after receiving vaccine. Afebrile				Y					Y	11/12/2008	11/12/2008	0	Head CT and Blood work normal	PVT	PUB						1						1	Blood test normal; Computerised tomogram normal; Grand mal convulsion	FLUN3~MEDIMMUNE VACCINES, INC.~500555P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0332555	11/17/2008	WA	2.0	2	.8	M	11/14/2008	3 hours later vomiting then joint swelling									U	11/10/2008	11/10/2008	0		PVT	UNK			Allergic to Omnicef ST swelling			1						1	Joint swelling; Vomiting	FLU3~SANOFI PASTEUR~U2769AA~4~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332556	11/17/2008	MD	85.0	85		F	11/15/2008	Pt developed hives approx. 1day after receiving the vaccine. Took a CVS allergy tab (unknown generic) She contacted the Dr to call her. Attempt to contact no answered.				Y					U	11/11/2008	11/12/2008	1		PUB	PUB	Unknown					1						1	Urticaria	FLU3~SANOFI PASTEUR~U2849AC~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332557	11/17/2008	TX	45.0	45		M	11/09/2008	Drowsiness, dizziness starting within 30 minutes of vaccine and lasting approx 24 hours.									Y	11/07/2008	11/07/2008	0		OTH	PVT		None	None			1						1	Dizziness; Somnolence	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332558	11/17/2008	TX	41.0	41		F	11/09/2008	Drowsiness; muscle weakness (legs); nausea; diarrhea; and dizziness starting within 30 minutes of vaccine lasting approximately 36  hours.									Y	11/07/2008	11/07/2008	0		OTH	PVT	Fluoxetine; WELLBUTRIN		Pituitary Adenoma; Previous Transient Ischemic attacks; Migraines			1						1	Diarrhoea; Dizziness; Muscular weakness; Nausea; Somnolence	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332559	11/17/2008	NJ	51.0	51		F	10/31/2008	The evening of the vaccine reports severe headache and very sore arm. Nose bleed (not severe stopped w/o medical intervention.									Y	10/29/2008	10/29/2008	0		PVT	PVT						1						1	Epistaxis; Headache; Pain in extremity	FLU3~SANOFI PASTEUR~U2784EA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332560	11/17/2008	WI	48.0	48		F	11/17/2008	Reaction started with itchy and red eyes at 6:30pm.  Sx worsened to include rapid heart rate and breathing difficulties.  She was seen at 11:15pm and given #1 EPI, #2 STEROID, 3# BENADRYL.  Given PREDNISONE 50mg X5 to take home.				Y					Y	11/14/2008	11/14/2008	0	None	PUB	PVT		No				1						1	Dyspnoea; Eye pruritus; Heart rate increased; Ocular hyperaemia	FLU3~SANOFI PASTEUR~U2810AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332561	11/17/2008	IL	78.0	78		M	10/30/2008	On the evening of October 17, 2008, patient and his wife came into the pharmacy for vaccination services. We discussed which vaccinations he needed by attempting to call where they suspected his last PNEUMOVAX vaccination took place. They could not provide that information, and they were not sure when the last PNEUMOVAX vaccination had taken place. It was decided that he would get both the Flu vaccine and PNEUMOVAX that evening. They were administered together the Flu in the left arm and the PNEUMOVAX in the right, at about 5pm. Universal precautions and standard IM injection techniques were used. The patient's wife called me on October 24, 2008, at 11:50a.m. to inform me that the patient had been admitted into the hospital on October 23, 2008, at about noon. She informed me that after leaving the pharmacy the couple had gone to dinner, and around 7:00 on the 17th he was experiencing an ill feeling and pain at the PNEUMOVAX injection site that she described as excruciating pain. They called the phone number provided on the VIS and were informed to take aspirin and apply ice to the injection site. Then at 10:00 p.m. they called the ER and were informed to do the same thing. She informed me that on Monday the swelling and redness on the arm was going down, but that he was having swelling in his legs and his ears were plugged. Their primary doctor started the patient on antibiotics. She informed me that he took the antibiotics and that still Thursday the arm was still swollen, red, and painful and thus, he was ordered to enter the hospital. Upon her request I called the physician and left a message with his staff that I was available for any questions and explained what vaccines were given. This was done at 12:24 p.m. October 24, 2008. I have not been contacted as yet by the doctor. On October 27, 2008, I contacted the wife to inquire on his status, and she informed me that he still had arm pain, but that he was coming home from the hospital that day, she thought.  12/24/08-records received for DOS 10/23-10/27/08-DC DX:Phlebitis, right upper arm. Right shoulder hematoma, deltoid, post vaccination for flu. Decreased range of motion right shoulder, post vaccination for flu. Presented with C/O severe pain in right shoulder consistent with phlebitis and hematoma. Admitted for intravenous antibiotics.				Y	Y	4			U	10/17/2008	10/17/2008	0		OTH	PUB			12/24/08-records received-PMH: Coronary artery disease. Diabetes mellitus. Hypertension. Hyperlipidema. Anemia with equivocal labs for iron deficiency, B12 and folate deficiency workup, colonoscopy 2004.			1						1	Ear discomfort; Erythema; Injection site pain; Malaise; Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89975~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0813K~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0332562	11/17/2008	ME	14.0	14		M	11/17/2008	Vascular headache probably secondary to MENACTRA vaccine. Severe headache onset within minutes of vaccination. Vomited once. Treated with Ibuprofen 800 mg every 4-6 hrs.				Y					U	11/12/2008	11/12/2008	0		PVT	PVT		None Known				1						1	Immediate post-injection reaction; Vascular headache; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500548P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U2817AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0332569	11/17/2008	CA	69.0	69		M	11/14/2008	He had received a PNEUMOVAX shot on November 5th, in the right arm. yesterday it was red and swollen, he felt achy all over and had a bit of chest congestion and cough. He took ADVIL PM and is noticing that he is better today. I does look like an allergic reaction. He has benefited already from some ADVIL PM he took so I				Y					Y	11/06/2008	11/08/2008	2		UNK	UNK						1						1	Cough; Erythema; Hypersensitivity; Oedema peripheral; Pain; Pulmonary congestion	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA381AA~UNK~ID~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0978X~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332575	11/17/2008	PA	32.0	32		F	11/14/2008	Immediately upon vaccination, the site bruised and swelling @ 1 cm in diameter and 2-3 mm high.									Y	11/13/2008	11/13/2008	0		UNK	UNK		None				1						1	Immediate post-injection reaction; Injection site haematoma; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA381AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0332576	11/17/2008	TX	2.0	2	.5	M	11/17/2008	Child  was inadvertently given the Preservative Free Influenza vaccine for ages 3 - 18 years of age instead of the Preservative Free Influenza vaccine for 6 - 35 months of age. No adverse event occured.									U	11/10/2008			N/A	PUB	PUB	N/A	None known	None known			1						1	Inappropriate schedule of drug administration; No adverse event	FLU3~SANOFI PASTEUR~U2795AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332580	11/17/2008	PA	52.0	52		F	11/17/2008	FRIDAY NIGHT STARTED WITH SEVERE BURNING SENSATION IN THROAT.SATURDAY:WEAK, WHOLE BODY ACHINESS, CHILLS. SUNDAY: FATIGUE EASILY, CHEST IS TIGHT, COUGHING, EARACHES, SINUS PAIN ON L SIDE. MONDAY: STILL FEELS WEAK, THROAT STILL SORE& BURNING,CHEST IS TIGHT, SINUS PAIN, CHILLS, A BIT DIZZY AT TIMES.i FAXED A NOTE TO MY PHYSICIAN SINCE THEIR LINE IS BUSY. i DON'T HAVE THE INFO ON THE VACCINE.									N	11/13/2008	11/14/2008	1	NONE	PVT	UNK	JUST VIT ZINC, BALCK GOHOSH, DHEA, GLUCOSAMINE SULFATE, ZYFLAMMED, FISH OIL. I TOOK FOR THE FLU REACTION:TYLENOL,ADVIL,OCCILLOCCOCINUM,1/2 SKELAXIN BID,DIMETAPP,NASAL SALINE, GARGLE THROAT, RUB CHEST WITH VICVAPORRUB.RELENZA ON MONDAY AM FO	NONE	NONE	NONE~ ()~NULL~~In Patient		1						1	Asthenia; Chest discomfort; Chills; Cough; Dizziness; Ear pain; Fatigue; Pain; Sinus headache; Throat irritation	FLU3~SANOFI PASTEUR~U2810AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332582	11/17/2008	CA	45.0	45		F	11/17/2008	Developed facial shingles three days after flu shot and primary physician requested reporting via the VAERS.									Y	10/31/2008	11/03/2008	3		PVT	PVT	None	None	Shingles 20 years ago			1						1	Herpes zoster	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89977~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332584	11/17/2008	WI	56.0	56		M	11/17/2008	Began to feel shaky on two hours after the shot which was given on 10.29.08 - broke out in hives later that nite and have been breaking out ever since the shot - will be seeing my MD on 11.18.08 as this condition has been ongoing since I received the shot.				Y					N	10/29/2008	10/29/2008	0		UNK	UNK						1						1	Tremor; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~87950~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0332585	11/17/2008	CA	81.0	81		F	11/17/2008	Abdominal distress (first 1-2 days) followed by serious diarrhea (7 days; at reporting, symptoms are waning but have not abated)                  (Pain at injection site and severe swelling up to shoulder for 2 days also noted)               (General malaise for 2 days)									N	11/07/2008	11/07/2008	0	None	PVT	UNK	Neurontin, Inderal, hydrochlorothiazide, aspirin, Levoxyl, Lorazepam, allopurinol, Arimidex -- all taken daily for +1 year w/o side effects	None	N/A			1						1	Abdominal discomfort; Diarrhoea; Injection site pain; Injection site swelling; Malaise; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332586	11/17/2008	MI	1.0	0	.0	F	11/17/2008	Rash developed 10 days after injection									U	11/03/2008	11/12/2008	9	None	PVT	PUB	None	NONE	None			1						1	Rash	FLU3~SANOFI PASTEUR~UT2792CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0980x~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C73446~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0787x~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0332587	11/17/2008	FL	26.0	26		F	11/17/2008	CLIENT STATED THAT THE FIRST TWO DAYS AFTER THE FLU SHOT, SHE HAD A RASH AND MY ARM FELT HEAVY.  THERE WAS SOME PAIN, BUT NOT ALOT.  SHE THEN GOES ON TO SAY THAT THE THIRD DAY AFTER THE FLU SHOT SHE HAD A SHARP BURNING PAIN THAT RADIATED UP HER RIGHT NECK AND DOWN HER RIGHT ARM.  SHE SAID THAT SHE TOOK TYLENOL, USED THE COLD COMPRESSES, TOOK HOT SHOWERS, BUT DID NOT GET ANY RELIEF AND CANNOT SLEEP.  SHE DID NOT TAKE HER TEMPERATURE SO SHE IS NOT AWARE OF A FEVER.  SHE CALLED OUR OFFICE BEFORE GOING TO SEE A DOCTOR.  ENCOURAGED HER TO SEE HER PRIMARY CARE PHYSICIAN. SHE SAID THAT SHE DOES NOT HAVE ONE SHE WOULD HAVE TO GO TO THE ER.  2/5/09 Received ER medical records of 11/21/2008. FINAL DX: cervicalgia; pain in limb Records reveal  patient experienced right side neck & shoulder pain x several weeks.  Exam noted sever muscle spasm of right posterior neck & severe soft tissue tenderness of right upper neck.  Tx w/steroids & pain meds.  Phone f/u revealed patient improved on 11/24/08.				Y					N	11/06/2008	11/08/2008	2	NONE  LABS: CT scan c-spine revealed disk herniation C5-C6; disk bulging C6-C7.	UNK	UNK	ORTHO-TRICYCLINE LOW	NONE	NONE			1						1	Burning sensation; Pain in extremity; Rash; Sensation of heaviness; Sleep disorder	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89685~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HPV4~MERCK & CO. INC.~0070X~2~IM~LA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0332588	11/17/2008	FL	65.0	65		M	11/17/2008	FLULAVAL given 1 minute after my wife, 33 days ago.Pain in my left arm where shot was given. After two days had passed I was in excruiating pain, so much so that I went back to doctor. Since that time I have had and MRI of my shoulder and arm. I have been on steriods, darvocet, percoset, had xrays of my shoulder and arm via an orthopedic doctor. Manufacturer offered NO help whatsoever. No my hand is in a splint.Have had physcial therapy for week and still in pain. what to do? and why?				Y					N	10/08/2008	10/09/2008	1	listed above. I am extremely upset that my arm has not gotten better. I have been unable to do anything for 33 days. MRI, XRAYs, pain killers.Can't sleep. Help.	PVT	PUB		none	none			1						1	Injection site pain; Nuclear magnetic resonance imaging; X-ray	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0332589	11/17/2008	CA	44.0	44		F	11/17/2008	I experienced plugged up ears all day starting within minutes of shot & sharp pain through my right knee and into my thigh for a few hours on that day. Increased soreness, hardness, and redness of area of shot over weekend. Today it is starting to spread out - but less sore, hard, and red... starting to itch. Too busy to get checked out - so I did not do it. I have never had any reaction to these shots before.									U	11/14/2008	11/14/2008	0		PUB	UNK	none when given. Ibuprofin after along with a decongestant for the ears... didn't help.	none	none			1						1	Arthralgia; Ear discomfort; Immediate post-injection reaction; Injection site erythema; Injection site induration; Injection site pain; Injection site pruritus; No reaction on previous exposure to drug; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~4~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332590	11/17/2008	CA	10.0	10		M	11/17/2008	11/06/2008 received FluMist at Flu Clinic/Exercise.  11/11/08-noticed slight rash on rt. side of upper lip, during weekend spread to outer left side of nostril. MOC took child to clinic on 11/17/08, rash dx. as staph infection (impetigo) given medication and instructions to stop spread, also told to report it to Public Health.										11/06/2008	11/11/2008	5		UNK	UNK		none	none	none~ ()~~0.00~In Patient|none~ ()~~0.00~In Sibling		1						1	Impetigo; Rash; Staphylococcal infection	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0332591	11/17/2008	TX	35.0	35		F	11/17/2008	GENERALIZED HYPERSENSITIVITY TO TOUCH LASTING ONE DAY; VOMITING LASTING ONE DAY; FEVER LASTING TWO DAYS; SWOLLEN LYMPH NODES LASTING FOUR DAYS				Y					Y	11/14/2008	11/15/2008	1	NA	UNK	PVT	NONE		ASTHMA			1						1	Hyperaesthesia; Lymphadenopathy; Pyrexia; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88636~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1381U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332593	11/17/2008	LA	44.0	44		F	11/17/2008	Chills, fever; swelling/redness/tenderness to outer aspect of upper L arm immediately after injection, on third day of symptoms when seen by PCP.				Y					Y	10/24/2008	10/24/2008	0		UNK	PUB	Clarinex, Effexor, Plavix, pravastatin, lisinopril/HCTZ, tramadol, warfarin, clonazepam, Tylenol ES, omeprazole, darvocet, omega-3-fatty acids	None	gadolinium contrast, morphine, Tylox, Imitrex, erythromycin			1						1	Chills; Immediate post-injection reaction; Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0868X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332595	11/17/2008	ID	26.0	26		F	11/17/2008	Four days following administration of Fluarix, Lot Number AFLUA380CA, Expiration 6/30/09, I came down with facial palsy on the same side of the body (right) as the injection.  The palsy started with loss of taste sensation, moving through the mouth and up to the eye, resulting in partial paralysis by the following afternoon (complete paralysis of the mouth).  Current course of treatment is Prednisone and Zovirax in addition to Chinese herbs. 1/14/09 Reviwed ER medical records of 11/13/2008. FINAL DX: Bell's palsy Records reveal patient experienced gradual right sided facial numbness, inability to close right eye, droop right mouth, loss of right nasolabial fold x 1 day.  Tx w/antiviral & steroid meds.				Y					U	11/10/2008	11/13/2008	3		UNK	UNK	Prilosec, Vivelle dot	PTSD	6 weeks post-partum  PMH: migraine HA			1						1	Ageusia; Facial palsy	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA380CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0332596	11/17/2008	NY	61.0	61		F	11/17/2008	The morning after receiving the flu shot I had 2 hard red welts on my lower left back, the same side as the shot. 2 days later the same 2 hard welts appeared on my left ankle. 2-3 days later they moved to my left neck. 2-3 days later they moved to my lower left back. 2-3 later they moved to my left arm. 11/14 one welt moved to my right jaw. 11/16 one welt moved to my right upper arm. The welts are about 1 1/2 long to 1 wide. Always just 2. They start out as a hard lump, then get bright red start burning & have a slight itch. The welts that were on my ankle have left the bone at that area very sore.									N	10/21/2008	10/22/2008	1	None	UNK	UNK	Enalapril 20mg; Pravachol 40 mg; hydrochlorothiazide 12.5 mg	None	Penicillin			1						1	Erythema; Pruritus; Skin burning sensation; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332598	11/17/2008	WI	58.0	58		F	11/17/2008	Patient is experiencing left shoulder pain which she feels is in result of her flu vaccine adminsitered on 10/27/08. She stated 2 hours after the injection she started noticing a burning type pain and a low grade fever. She was also unable to reach behind her head. No swelling or redness was present. She had been seen by Dr. on 11/10/08. A left shoulder xray was obtained. Agreed upon recommendation - physical therapy for the shoulder per Dr. dictation.									U	10/27/2008	10/27/2008	0	Shoulder xray 11/10/08	UNK	UNK						1						1	Injected limb mobility decreased; Musculoskeletal pain; Pain; Pyrexia; X-ray limb	FLU3~SANOFI PASTEUR~U2772AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332600	11/17/2008	OR	36.0	36		F	11/17/2008	After the vaccination, my arm was sore but I expected this.  Two days after the vaccination, there was swelling around the injection site and the arm continued to be sore.  Three days after the vaccination, the swelling around the injection site worsened, so I went back to the clinic.  The doctor on duty identified it as a staph infection and prescribed Azithromycin.  He told me to take two immediately, then continue to take 1 per day for 6 days.  The arm continued to ache for about a week.				Y					U	11/03/2008	11/05/2008	2	Returned to the clinic on 11/6/08 where the doctor diagnosed the infection by looking at the injection site.	PUB	PVT	albuterol inhalor	I had a cough, but no fever.	asthma			1						1	Injection site swelling; Pain in extremity; Staphylococcal infection; Tenderness	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0332601	11/17/2008	TX	63.0	63		F	11/17/2008	Patient arrived at the pharmacy 2 days after vaccine administration with swollen lymph nodes in the clavicular area.  She described feeling general ache on the night of vaccine administration.  The day after, vaccination, she described seeing the enlarged lymph node in the clavicle area.  Patient was followed up the day later and also described having tenderness and pain in her axillary area as well.									U	11/14/2008	11/15/2008	1		UNK	PVT						1						1	Axillary pain; Lymphadenopathy; Pain; Tenderness	FLU3~SANOFI PASTEUR~u2761aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332602	11/17/2008	IN	3.0	3		M	11/17/2008	Child received influenza vaccine at approximately 1:30 p.m. on 11/14/08, about 1/2 hour after administration, father called to report that child was out of it, looked pale, doesn't want to do anything.  Nurse advised parent to lay child down, elevate legs/feet and use cold cloth or ice pack.  Father advised by nurse that if he continues to have problems to take the child to the ER, since child does not have a primary physician.  11/17/08 Follow-up call to parents by RN, mom reports child was taken to ER, his temperature was 102-103, he very pale and a swollen throat, Mom states child started to come around after ER gave medication (mother unaware what medication was given), and child was sent home.  Child today is having no problems. Information given to mom regarding VAERS and vaccine compensation program.  Advised mother this would be reported by this office to VAERS.				Y					Y	11/14/2008	11/14/2008	0	Unknown	UNK	UNK	unknown	none known	none known			1						1	Decreased activity; Pallor; Pharyngeal oedema; Pyrexia	FLU3~SANOFI PASTEUR~U2755AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332603	11/17/2008	MO	45.0	45		F	11/17/2008	Large amount of swelling and redness at site of injection (left arm) lasting several hours after administration.  No treatment.									Y	11/13/2008	11/13/2008	0		PUB	PVT	Flexeril, hydrocodone/acetaminophen, metoprolol, aspiriin, Plavix, Lipitor	GI Bleed	Allegies: Erythromycin, NSAIDS			1						1	Injection site erythema; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA373BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0743X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332604	11/17/2008	TX	43.0	53		F	11/17/2008	Receive vaccination in left deltoid on Saturday 11/15/08. Began having redness and swelling early Monday morning, 11/17/08.  Went to doctor that afternoon to get it checked.				Y					Y	11/15/2008	11/17/2008	2		UNK	PVT	NONE	NONE KNOWN	NONE KNOWN	UNKNOWN~ ()~NULL~~In Patient		1						1	Erythema; Swelling	FLU3~SANOFI PASTEUR~U2741aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332607	11/17/2008	SC	64.0	64		F	11/17/2008	ADMINISTERED IN LEFT THIGH MUSCLE. REPORTED FEVER OF 103DEGREES FOR 2 DAYS. SMALL RED AREA AT INJECTION SIGHT, 2 INCHES AWAY WAS FEVERISH AREA SIZE OF SMALL ORANGE. MUSCLE SORENESS TO THE POINT OF BEING UNABLE TO WALK ON LEG FOR 3 DAYS. ALL SYMPTOMS RESOLVED ON THEIR ON OWN IN 6 DAYS. USED TYLENOL AND HEAT/COLD FOR COMFORT AND FEVER.									Y	11/11/2008	11/11/2008	0	NONE	UNK	PVT	neurontin 100mg    synthroid 0.15					1						1	Abasia; Injection site erythema; Injection site warmth; Myalgia; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89966~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0868X~1~IM~LL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332609	11/17/2008	WI	57.0	56		M	11/17/2008	3 hours after receiving the flu shot (inactivated influenza vaccine 2008-09) I was stricken with the most severe back pain I've ever felt, except for when I had back surgery ~3 years ago. It felt like a disc in my lower back approx. L4 or L5 had slipped half a notch and I experienced exruciating pain. It was all I could do to drive home and go to bed, laying face down until morning. I slowly recovered over the next 3 days.									Y	08/14/2008	08/14/2008	0		PVT	UNK						1						1	Back pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332610	11/17/2008	CA	64.0	64		M	11/17/2008	Left facial paralysis with onset 11/16/08.  Diagnosed with Bell's palsy on 11/17/08. HEENT: Fundi nl. TM's and ears clear. no vessicles. OP clear. nares patent.  neuro:      A & O; CN 2-12 nl except for 7th cranial nerve: L forehead weak,  can't raise L eyebrow, can't close L eye; L side of mouth drooping; sensation to  light touch nl all ext; strength 5/5 all ext; muscle tone and bulk nl.  coordination nl to past point, rapid alternating movements; gait nl; DTR's symmetric and non-pathologic all extremities; romberg negative; babinski negative; no clonus.				Y					U	11/10/2008	11/16/2008	6		UNK	PUB	1)   CLONIDINE 0.2MG/24HR PATCH APPLY ONE PATCH TO SKIN     ACTIVE        EVERY WEEK . CHANGE SITES REGULARLY. 2)   HCTZ 25/TRIAMTERENE 37.5MG TAB TAKE 1 TABLET ORALLY    ACTIVE        EVERY DAY (90 DAY SUPPLY) 3)   IBUPROFEN 800MG TAB TAKE	None	Asthma, hypertension, no none drug allergies	~ ()~24~~In Patient		1						1	Facial palsy	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~AFLLA174AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0332614	11/17/2008	UT	40.0	40		F	11/17/2008	This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 40-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 12 November 2008 at 10:10, the subject received a dose of FLULAVAL (.5 ml, unknown, right arm). On 12 November 2008, immediately after vaccination with FLULAVAL, the subject experienced swelling injection site, injection site redness, injection site pain. On 12 November 2008 at 10:20, the subject experienced dizziness, and panic sensation. The subject was treated with Epinephrine. On 12 November 2008 at 11:20, the subject experienced trouble breathing and throat tightness. The healthcare professional reported the subject received FLULAVAL at a flu vaccine clinic held at a job site at 10:10 and immediately experienced swelling, redness, and pain at the injection site. The subject was monitored for five to ten minutes and then felt panicked and dizzy. The subject then received epinephrine 0.5mL, felt better and went back to work. One hour later the subject returned complaining that she was having trouble breathing and her throat was tightening. She was then given a second dose of epinephrine (0.3mL). She did not respond to the epinephrine so she was given another 0.3mL dose. The subject did respond and stated she felt fine. She was advised to go to the emergency room, but the subject felt she did not need to and she therefore, did not go to the ER. The reporter stated these adverse events resolved between 12-12:30 pm. The healthcare professional considered the events were clinically significant (or requiring intervention). On 12 November 2008, the events were resolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL.				Y					Y	11/12/2008	11/12/2008	0	UNK	OTH	PVT		Unknown	Concomitant medications were unknown.  No relevant medical history.  The subject had previously received influenza vaccinations and no adverse events were reported.  No adverse events were reported following receipt of prior immunizations.  The healthcare professional reported another case, see A0756602A.		A0756598A	1						1	Dizziness; Dyspnoea; Immediate post-injection reaction; Injection site erythema; Injection site pain; Injection site swelling; Panic reaction; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA172AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0332624	11/17/2008	WA	38.0	38		F	11/17/2008	10/20/08 FLUVIRIN given. 11/17/08 patient complains of tingling, burning sensation on left arm. Not constant, on and off.  (vaccine in left arm).									U	10/20/2008	10/27/2008	7		OTH	OTH	NEXIUM 40 mg; YASMIN; ALLEGRA	None	Seasonal allergies			1						1	Burning sensation; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332625	11/17/2008	CA	41.0	41		F	11/17/2008	20x15 cm. hive in Rt. upper arm consisted with immunization rx.									U	11/11/2008	11/12/2008	1		OTH	OTH						1						1	Injection site urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332626	11/17/2008	ND	66.0	66		M	11/13/2008	Pt states had red, swollen, sore right arm from elbow to armpit - fever and was achey, Tried heat and made arm burn. Is on Naprosyn antibiotic already from other										11/10/2008				UNK	UNK						1						1	Burning sensation; Erythema; Oedema peripheral; Pain; Pain in extremity; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89987~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~05560~UNK~SC~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332628	11/17/2008	PA	11.0	11		F	11/17/2008	Flumist given 11/2/08.  Developed HA 11/10.  Neck pain, nuchal rigidity 11/13.  Afebrile.  Head MRI negative.  HA resolved 11/14, neck pain resolved 11/16.  Abd pain 11/16, V x2.  No D.  Temperature 99.2.  No P.O., abd pain severe - ER.  P.E. sig. for afebrile, RUQ abd pain to palp, severe leg pain to palp.  CXR negative.  WBC = 19K with 90% polys.  U/A positive ketones only.  Pain resolved with NSO4 and IVF.  Today (11/17) without do.				Y					Y	11/02/2008	11/10/2008	8	As above	PVT	PVT		None	None			1						1	Abdominal pain; Body temperature increased; Headache; Muscle rigidity; Neck pain; Nodule; Nuclear magnetic resonance imaging normal; Urine analysis abnormal; White blood cell count increased	FLUN3~MEDIMMUNE VACCINES, INC.~500591P~4~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0332630	11/17/2008	TX	47.0	47		F	11/13/2008	Pt developed area of tenderness 2 days later. Redness, slight warmth - tenderness to area. Tx Doxycycline dose 150mg Tid x 7 days. DIFLUCAN 150mg po Qdx8				Y					Y	11/11/2008	11/13/2008	2	Xray - cellulitis at site- ABX given Clindamycin 150mg Tid po x 7 days	OTH	PVT	Amoxicillin		Dental problems			1						1	Cellulitis; Erythema; Skin warm; Tenderness; X-ray abnormal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89622~4~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0332632	11/17/2008	MD	4.0	4		M	11/17/2008	Had flu shot on Wed - felt fine; Thurs. sick all day - stomach pain, projectile vomiting X 2 and 5 bowel movements (4 solid and 1 liquid) Fri. felt weak as a kitten									Y	10/12/2008	11/13/2008	32		PUB	OTH	ADVAIR, GLUCOTROL, NEURONTIN, SYNTHROID, GLIPIZIDE, ZOCOR, ASA, ALEVE, Zinc, Cacium, Vitamin B1, MVI	Cold X 4-5 weeks prior	bronchitis, asthma, DM, thyroid CAhx			1						1	Abdominal pain upper; Asthenia; Frequent bowel movements; Malaise; Vomiting projectile	FLU3~SANOFI PASTEUR~U2898FA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332633	11/17/2008	IL	71.0	71		F	11/17/2008	Patient says arm hurts to move up and away from body and has had ever since vaccination. Patient has not been seen by MD yet. I encouraged her to go to the doctor to get it check out. No outward signs or symptoms just the muscle pain.									U	10/13/2008	10/13/2008	0	Has not been to MD	OTH	OTH	COZAAR 50; ZOCOR 20; TOPROL 400; HYDREA 500	None	High cholesterol; high blood pressure			1						1	Hypokinesia; Myalgia; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332634	11/17/2008	OH	39.0	39		F		Began throwing PVC's on 10/5/08 sent to ER, EKG done, labwork, CXR sent home from ER with abnormal EKG saw cardiologist 10/9/08. US of heart normal.				Y					Y	10/02/2008	10/05/2008	3	Ultrasound Heart; EKG; CXR; LABS	PVT	PVT		None	None			1						1	Chest X-ray; Electrocardiogram abnormal; Laboratory test; Ultrasound scan normal; Ventricular extrasystoles	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA165AA~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0332635	11/17/2008	MA	14.0	14		F	11/17/2008	Pt received 1st dose of GARDASIL. Pt began seizing in approx 3-4 seconds after receiving GARDASIL vaccine.									Y	11/17/2008	11/17/2008	0		PVT	PVT		Seizure				1						1	Convulsion	FLU3~SANOFI PASTEUR~U2766AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0279X~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2734AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B027AA~6~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0332636	11/17/2008	WI	39.0	39		F	11/17/2008	45 minutes after AFLURIA complained of feeling hot and nauseated. RN checked vitals: BP 144/100 pulse 72 skin warm and dry. Appears fine. Was talking on telephone when RN arrived for assessment. Voicemail left at pt's home 11/14.									U	11/06/2008	11/06/2008	0	None	PUB	PVT	Unknown	None	Unknown			1						1	Feeling hot; Hypertension; Nausea	FLU3~CSL LIMITED~02749111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0332637	11/17/2008	WI	52.0	52		F	11/17/2008	Patient returned to flu clinic about 2 hours after injection of flu vaccine, complaining of discomfort and increased temperature. Per RN assessment, revealed mild redness around site.									U	11/06/2008	11/06/2008	0	None	PUB	PVT	Unknown	None	Unknown			1						1	Body temperature increased; Discomfort; Injection site erythema	FLU3~SANOFI PASTEUR~02749111A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332638	11/17/2008	WI	63.0	63		F	11/17/2008	Swelling at site of FLUZONE shot. Pain in deltoid, shoulder, and neck. Area warm per RN.									U	11/07/2008	11/07/2008	0	None	PUB	PVT	Unknown	None	Unknown			1						1	Injection site pain; Injection site swelling; Injection site warmth; Musculoskeletal pain; Neck pain	FLU3~SANOFI PASTEUR~02749111A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333797	11/17/2008	PA	0.53	0	.5	F	11/14/2008	Information has been received from a consumer her 6 month old daughter who on 03-OCT-2008 was vaccinated with ROTATEQ. Concomitant vaccinations on the same day included Pneumococcal vaccinel (manufacturer unknown), Influenza vaccine (manufacturer unknown), Hib (manufacturer unknown) and DTaP (manufacturer unknown). It was noted that within 24 hours of vaccination the patient experienced fever, irritability and loss of appetite. There was no medical attention sought. The patient was treated with TYLENOL. It was reported that the patient's symptoms lasted about 24-36 hours post vaccination. At the time of the report, the patient seemed fine. There was no product quality complaint involved. Additional information has been requested.									Y	10/03/2008	10/03/2008	0	Unknown	OTH	OTH			Unknown		WAES0810USA01143	1						1	Anorexia; Irritability; Pyrexia	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~MERCK & CO. INC.~~UNK~UN~UN~HIB (PEDVAXHIB)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1|RV5~MERCK & CO. INC.~~UNK~UN~UN~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0334042	11/17/2008	NY	13.0	13		F	11/14/2008	Information has been received from a physician concerning a 19-year-old female patient, who on 09-OCT-2008 received a third dose of 0.5 ml GARDASIL (lot # 660618/0572X, injection site not reported) via intramuscular route.  Concomitant vaccination included a dose of FLUZONE (preservative free).  The patient had previously received her first dose of GARDASIL (lot # 658556/1060U), together with a dose of MENACTRA and DTAP on 22-FEB-2008; and her second dose of GARDASIL (lot # 658556/1060U) on 13-APR-2008.  On 09-OCT-2008, within 5 or 10 minutes after administration of the third dose of GARDASIL, the patient reported that she felt dizzy and lightheaded and sunk to the floor.  Loss of consciousness was suspected.  She was very confused, pale, color poor and limbs cold.  The patient was placed on exam table.  She did not have a palpable pulse; her heart rate was in 40's via stethoscope and her blood pressure was 80/50.  She was diaphoretic.  The patient was given some apple juice and condition monitored.  According to the patient, she had not eaten breakfast.  After given more juice, the patient's heart rate improved and her blood pressure rose to 90/60.  After being observed for a while she was sent home.  The patient also had a similar episode a few weeks ago after running at a track.  On a follow up phone call from the doctor on 10-OCT-2008, the patient was fine.  Additional information has been requested.				Y					Y	10/09/2008	10/09/2008	0	Unknown	OTH	OTH			None		WAES0810USA01978	1						1	Blood pressure decreased; Condition aggravated; Confusional state; Dizziness; Heart rate decreased; Hyperhidrosis; Loss of consciousness; Pallor; Peripheral coldness; Pulse absent	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0572X~3~IM~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0334125	11/17/2008		21.0			F	11/14/2008	Information has been received form the mother concerning her 21 year old daughter with a history of drug reaction to VERSED who in October 2006 was vaccinated with a first dose of GARDASIL and on unspecified dates was vaccinated with second and third doses of GARDASIL. Concomitant therapy included FLUSHIELD. It is reported that the patient received all three dose of GARDASIL and then two times in March 2008 she had a PAP Test done and they both came back abnormal. In March 2008, the patient was diagnosed with a mild case of dysplasia (HPV). At the time of reporting, the patient's mild case of dysplasia (HPV) persisted. The patient had sought medical attention of the physician. No further information is available.				Y					N		03/01/2008		Pap test, 03/??/08, mild dysplasia; Pap test, 03/??/08, mild dysplasia	OTH	OTH		Drug hypersensitivity			WAES0810USA02423	1						1	Dysplasia; Smear cervix abnormal	FLU3~PFIZER\WYETH~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUSHIELD)~1|HPV4~MERCK & CO. INC.~~3~UN~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0334790	11/17/2008	TX	11.0			F	11/14/2008	Information has been received from a physician concerning a 11 year old female patient with no pertinent medical history and no drug reactions or allergies, who on 16-OCT-2008, was vaccinated, IM, with the first 0.5 ml dose of GARDASIL. Concomitant therapy included influenza virus vaccine administered on 16-OCT-2008. On 20-OCT-2008, the patient experienced left-side facial swelling, left neck pain and a feeling like her throat is swollen. The patient was examined in the office on 21-OCT-2008, and a cervical x-ray has been ordered. The patient was scheduled for a consultation with an unspecified ENT specialist on the afternoon of 21-OCT-2008. At the time of reporting, the adverse events were ongoing. Additional information has been requested.				Y					N	10/16/2008	10/20/2008	4	Unknown	OTH	OTH			None		WAES0810USA03951	1						1	Neck pain; Pharyngeal oedema; Swelling face	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~1~IM~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0334914	11/17/2008					F	11/14/2008	Information has been received from a medical assistant concerning a female who was vaccinated with a second dose of GARDASIL.  Secondary suspected therapy included INFLUENZA (unspecified).  The patient experienced vomiting 10 minutes after receiving GARDASIL and flu vaccination.  Medical attention was received in the office.  At the time of reporting, the outcome was unknown.   Additional information has been requested.									U					OTH	OTH	Unknown		Unknown		WAES0810USA04787	1						1	Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~2~UN~UN~HPV (GARDASIL)~1	USA		Influenza
0334987	11/17/2008	MO	16.0	16		F	11/14/2008	Information has been received from a registered nurse concerning a 16 year old white female who on 23-OCT-2008 in the PM was vaccinated with GARDASIL IM in the right arm.  Concomitant therapy included INFLUENZA (unspecified) (manufacturer unspecified).  On 23-OCT-2008 the patient experienced vomited immediately after the injections.  The patient felt better afterwards.  At the time of the report, the patient was recovered.  No further information is available.									Y	10/23/2008	10/23/2008	0	Unknown	PVT	OTH			Unknown		WAES0811USA00153	1						1	Immediate post-injection reaction; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~UNK~IM~UN~HPV (GARDASIL)~1	USA		Influenza
0335015	11/17/2008	TX	0.9			F	10/15/2008	A non-serious, spontaneous report of administration of FLUMIST to a eleven-month-old female infant was received from a health professional. There was no adverse event associated with this medication error; treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post marketing. Commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.									Y	10/15/2008	10/15/2008	0		OTH	OTH	Concomitant not reported				MEDI0007275	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~IN500560P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0332646	11/18/2008	CO	64.0			M	11/05/2008	Flu shot 10/28. Not feeling well just after getting flu shot. Fine red itchy rash all over body which developed yesterday. Reports throat is itchy but able to swallow with no difficulty. Symptoms: Skin rash, Treatment Drugs used: DIPHENHYDRAMINE dose 25 units: MG Freq: PRN Route; PO, HYDROCORTISONE dose: Units: Freq: PRN Route: TOP					Y				Y	10/28/2008	10/31/2008	3	Temperature, 97.4 F,11/01/2008; Pulse, 58, 11/01/2008; Respiration, 14, 11/01/2008; Blood Pressure, 121/84, 11/01/2008; Weight, 168 lb, 11/01/2008; Pulse Oximetry, 95, 11/01/2008	UNK	UNK			No prior allergic reaction to flu vaccine.			1						1	Body temperature; Heart rate decreased; Malaise; Oxygen saturation normal; Rash erythematous; Rash generalised; Rash pruritic; Respiratory rate; Throat irritation; Weight	FLUX~UNKNOWN MANUFACTURER~892973P~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0332647	11/18/2008	OH	33.0	33		M	10/23/2008	Pt called office stated he was feeling nauseous and had vomited. Stated he received Flu vaccine before and had no issues. Called pt at 14:55 to check on him - he was at work, stated nausea and sweating decreased, he took Tylenol and axixity decreased. Stated he would se how he felt tomorrow morning.									U	10/23/2008	10/23/2008	0		PUB	PUB	Unknown	None				1						1	Hyperhidrosis; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U2832AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332649	11/18/2008	NJ	6.0	6		F	11/13/2008	When administered FLUMIST to Pt little or no solution came out prior to removal of clip on the plunger. When inserted into other nostril it seemed all or most of the solution was administered at that time. This happened w/2 different nurses and when one was practiced on.										11/13/2008	11/13/2008	0		UNK	UNK						1						1	Medical device complication	FLUN3~MEDIMMUNE VACCINES, INC.~500545P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0332650	11/18/2008	LA	65.0	65		F	11/12/2008	No adverse event reported by patient from DTAP administration.									Y	11/06/2008				PUB	PUB	Unknown	None	Unknown		LA081102	1						1	Inappropriate schedule of drug administration	DTAP~SANOFI PASTEUR~U2356CA~1~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2848AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0961U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332663	11/18/2008	IA				U	11/14/2008	This serious case was received from a physician on 06 November 2008, and represents a cluster of six or seven patients. SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. A physician reported that five or six employees at a local hospital had experienced Bell's Palsy within two weeks of receiving FLUZONE SV (lot numbers, date of administration, and patient details not provided). Additionally, the physician reported that at least one employee at another local facility had also experienced Bell's Palsy. The physician, who was a pediatrician, had not seen any cases of Bell's Palsy in her own practice. Outcome was unknown. Documents held by sender: None.				Y					U					UNK	UNK			Not reported.		200803508	1						1	Facial palsy	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332664	11/18/2008	TX				M	11/14/2008	Initial report received from another manufacturer on 06 November 2008 who received the report from a healthcare professional. An unidentified male patient (age not reported) had received a flu vaccine (trade name, manufacturer, lot number not reported) and became very ill and convulsions. The patient sought medical attention. No additional information is available. Documents held by sender: None.				Y									Not reported	UNK	UNK			Not reported		200803513	1						1	Convulsion; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0332668	11/18/2008	MS	40.0	40		F	11/17/2008	Notified by hospital of admission due to ITP - possibly related to flu vaccine.  12/22/2008 MR received for DOS 11/6-16/2008 with D/C DX:  ITP-platelet count now 54K.  Anemia, probable acute blood loss anemia-hematocrit stable at 31.  Admitted with heavy menstual bleeding and mucosal/skin bleeding and petechiae-rsolved (2' to #1).  HTN-probably 2' to steroids-stable on Norvasc.  Mild hyperglycemia 2' to steroids. Anxiety d/o. Pt presented  with heavy menstual bleeding, bleeding spots on shins and thighs and oral mucosal bleeding.  Platelet ct on admission = 7K. Admitted for thrombocytopenia and started on steroids. Required several platelet transfusions. Platelets took 9-10 days to increase to 54K. D/C for outpt f/u.					Y	10			Y	10/17/2008			get records from hospital. Labs and Diagnostics:  Platelets 2-54K. LD 993. Glucose increased throughout stay.	OTH	PVT		None	None. PMH:  Anxiety d/o.			1						1	Idiopathic thrombocytopenic purpura; Contusion; Haemorrhage; Idiopathic thrombocytopenic purpura; Platelet count decreased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89989~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89989~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Hospitalisation	Influenza
0332672	11/18/2008	TN	36.0	36		F	11/17/2008	Patient had vaccine at approximately 1:00pm and at 6:00pm began having top lip swelling and sore throat.  Not witnessed.  Patient had eaten lean Quisine for lunch around noon.									Y	11/15/2008	11/15/2008	0		OTH	OTH	TOPOROL (u) for BP vitamins	None	High BP			1						1	Lip swelling; Oropharyngeal pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA151AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0332673	11/18/2008	NY	54.0	54		F	11/17/2008	Fever 101-102 degrees 24hr after got FLURIX vaccine and PNEUMOVAX. Rash at site of injections. Diffuse malaise. Seen in office on 11/15/08.									N	11/12/2008	11/13/2008	1		PVT	UNK		None	Crohn's , Osteoporosis, Ankylosing Spondylitis, Vit. D deficiency			1						1	Injection site rash; Malaise; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA388BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0979X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332674	11/18/2008	VA	80.0	79		M	11/17/2008	PNEUMOVAX.  Extreme pain, some swelling, warm to touch. 3-4 inches above injection site to 10 inches below injection site and back of elbow at joint. Had weakness in arm.(couldn't hold coffee cup).									Y	11/12/2008	11/12/2008	0		OTH	PUB	SERAX; MECLIZINE; aspirin	None	Hyperplasia of prostate			1						1	Grip strength decreased; Injection site swelling; Injection site warmth; Muscular weakness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA388A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0551X~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332675	11/18/2008	IL	8.0	8		M	11/14/2008	8 x 6 cm red with mild swelling induration.									N	11/12/2008	11/13/2008	1		OTH	PUB	None	NO	NKA			1						1	Erythema; Induration; Swelling	FLU3~SANOFI PASTEUR~U2797CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332677	11/18/2008	NY	1.9	1	.9	F	11/18/2008	As per mom, symptoms started two days after receiving 1st flu vaccine.  Mom states she took child to hospital on 11/16/08.				Y					N	11/14/2008	11/16/2008	2		UNK	UNK						1						1	Adverse event	FLU3~SANOFI PASTEUR~UT2792CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332678	11/18/2008	NY	34.0	34		F	11/18/2008	c/o dizzy, SOB, chest pain, difficulty swallowing, eyes swelled.  Took Benadryl 25 mg per advice of OB/GYN Provider; Symptoms subsided 1/2 hour after BENADRYL, po.										11/12/2008	11/12/2008	0	None	PUB	PVT		Note, is 37 weeks pregnant	Allergy:  SULFA			1						1	Chest pain; Dizziness; Dysphagia; Dyspnoea; Eye swelling	FLU3~CSL LIMITED~02549111A~6~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0332679	11/18/2008	KY	1.8	1	.8	F	11/17/2008	Rash, macular in some spots, maculopapular in other areas, more in face, chest and abdomen lasted for 3-4 days. Rash appeared 24-30 hrs after immz.				Y					Y	11/12/2008	11/13/2008	1		PVT	OTH	None	None	PKU, Phenylalanine.			1						1	Rash maculo-papular	FLU3~SANOFI PASTEUR~UT2797FA~3~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332681	11/18/2008	NM	49.0	49		U		Woke up 130 after injection with painful R shoulder + swelling + rash in this area. Fever, chills, myalgia down throughout R side of body, down to hip. Temp to 103, swelling in axillary area, reddened area, nausea, mild headache.									Y	10/28/2008	10/29/2008	1	CBC; 25.7 WBC; 88% Neutrophils; Blood Cultured (-)	PVT	PVT	SINGULAR; ADVAIR; FLONASE; VICODIN; PATANOL; IMITRIX; ZYRTEC; XOPENEX	None	Sulfa; Trimipramine maleate; MUCOMYST			1						1	Blood culture negative; Body temperature increased; Chills; Erythema; Full blood count; Headache; Injection site pain; Injection site rash; Injection site swelling; Lymphadenitis; Myalgia; Nausea; Neutrophil percentage increased; Pyrexia; Swelling; White blood cell count increased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLAL83AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1383U~2~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332684	11/18/2008	MA	40.0	40		M	11/18/2008	Several hours after injection very sore arm. Next day reports arm was red swollen hot and painful. Resolving the following day.									Y	11/13/2008	11/13/2008	0	None	PUB	UNK		None	None			1						1	Erythema; Oedema peripheral; Pain in extremity; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0964U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332689	11/18/2008	NJ				F	11/18/2008	C/O pain at injection site and cannot lift arm				Y						10/29/2008				UNK	PVT						1						1	Injected limb mobility decreased; Injection site pain	FLU3~SANOFI PASTEUR~U2791DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332691	11/18/2008	OH	47.0	47		F	11/18/2008	Patient received vaccine from Student Nurse on 11/6/08.  Instructor present and cosigned paperwork.  Patient contacted HD on 11/18/08 at 9:00am and reported that she has had pain in arm since vaccination.  She stated that she saw her private Physician who informed her that she was not sure what was wrong with the injection site but that it could be infected and could potentially be Staph.  Dr. prescribed Bactrum.  Patient stated that she is beginning to lose the use of her arm and that the arm surface is pink and warm to the touch.  Advised patient to keep in contact me the Health Department.				Y					N	11/06/2008	11/06/2008	0		UNK	UNK						1						1	Erythema; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~U2768AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332694	11/18/2008	MN	2.0	2	.0	M	11/18/2008	Ataxia, vomiting, nasal pain , generalized weakness and tremor, left head tilt starting 3 hours after immunization and lasting approx. 12 hours. pt. was hospitalized. CT head negative and neurology quite concerned. Was scheduled for MRI but symptoms completely resolved by AM (I was the hospital attending staff). Likely a reaction to the attenuated virus itself.? if primary MD has already reported this reaction? 12/2/08 Reviewed hospital medical records of 11/7-11/8/2008. FINAL DX: possibly vaccine-related ataxia & vomiting. Records reveal patient experienced abnormal behavior after nap on day of vaccination w/left head tilt, left side weakness, falling to left side, nose pain, runny nose & vomiting.  Recent sick contacts in daycare.  Seen in Urgent Care & sent for admission.  Neuro consult done & found to be WNL.  D/C to home w/PCP f/u.					Y	1			Y	11/07/2008	11/07/2008	0	Negative CT head  LABS: CBC, chemistry, CRP, AST/ALT all WNL	UNK	UNK	Epi Pen Jr (pt. with multiple food allergies including egg)	None	Peanut, eggs, milk, wheat, soy  PMH: multiple food allergies including egg.  Slight developmental delay in walking at 18 mo.			1						1	Ataxia; Computerised tomogram normal; Posture abnormal; Rhinalgia; Tremor; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500553P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0332695	11/18/2008	NY	51.0	51		F	11/18/2008	Vaccine administered at 1330.  Patient states swelling began @ 1800.  Advised by Pharmacist to take Benadryl.  Benadryl 25 mg. po ineffective.  Peri oral swelling continued, eyese reddened, short of breath.  MD advised to go to E.R.  Patient received IV medications and fluids.  12/5/08 Reviewed ER medical records of 11/17/2008. FINAL DX: allergic reaction Records reveal patient experienced throat constriction, red eyes, sinus tachycardia, chest pressure.  Exam revealed throat swelling.  D/C to home on steroids.			Y	Y					Y	11/17/2008	11/17/2008	0		UNK	UNK	none	none	none  PMH: HTN.			1						1	Dyspnoea; Ocular hyperaemia; Oedema mouth	FLU3~SANOFI PASTEUR~U2749AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0332696	11/18/2008	MS	52.0	52		F	10/31/2008	Patient was taken to ER on 10/30/08 with temp of 103.4 F, nausea, vomiting and shakes.  States MD says she had localized redness and tenderness related to immumizations in Left arm.					Y	3			Y	10/29/2008	10/30/2008	1		UNK	UNK		None			MS102008	1						1	Body temperature increased; Erythema; Injection site erythema; Injection site pain; Local reaction; Nausea; Tenderness; Tremor; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~U2802AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0513N~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0332697	11/18/2008	KS	36.0	36		F	11/18/2008	Tenderness, erythema at injection site 12 hours post adminstration.  Facial flushing, lightheadedness, dizziness, just weird 40 hours post admistration, followed by itching.  Patient given loratadine 10mg bid, diphenhydramine 25mg hs, hydroxyzine hcl 25mg 2 doses 72 & 96 hrs post admin.  Albuterol MDI started 48 hours post admin. Symptoms resolving six days after admin, still itching.									Y	11/12/2008	11/13/2008	1		UNK	PVT	ortho tri-cyclen, flonase nasal spray					1						1	Dizziness; Feeling abnormal; Flushing; Injection site erythema; Injection site pain; Pruritus	FLU3~SANOFI PASTEUR~U2765AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332698	11/18/2008	CA	40.0	48		F	11/18/2008	Pt came in late in the evening of 11/17/08  to say that her vaccinated arm was hurting, that there had been since the time of the injection a sharp and constant pain.The site of the injection was unremarkable and did not appear swollen or bruised. She has not sought out additional medical help.										10/30/2008	10/30/2008	0		UNK	PVT		Pt  affirmed that she was not ill day of vaccine	Do not know			1						1	Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88805~UNK~ID~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332699	11/18/2008	MS	52.0	52		F	11/18/2008	Took flu shot 11/6/08.  Next morning woke up with flushed face and swelling of rt side of neck and stiffness.  Used heating pad to neck all day. Neck went down.  Small node felt in right side of nectk. Client also reported chills all next day but never took temperature. Took tylenol and benadryl on 11/8 started noticing swelling and itching at ear lobes, temporal areas and under jaws.  Small area 2 inch by 1 inch of pale rash at right side of face by ear on 11/13/08.  Still complaining 11/13/08.  Has not seen doctor but instructed to do so									Y	11/06/2008	11/07/2008	1		PUB	PUB	aleve, tylenol, and benadryl	none knkown	none known by client		MS112008	1						1	Auricular swelling; Chills; Flushing; Local swelling; Musculoskeletal stiffness; Pruritus; Rash	FLU3~SANOFI PASTEUR~U2802AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332700	11/18/2008	OH	33.0	33		M	11/18/2008	headache, stiffnes of neck, fever 102, suspecting viral meningitis, pneumonia.  11/21/08 MR received for DOS 11/12-17/2008 with dx:Viral meningitis vs influenza vaccination reaction.  Bilateral pneumonia.  Elevated LFTs. L maxillary sinusitis.  Headache.  Hypoxia.  Pt presented with myalgias, aches, stiff neck, fever, chills, poor appetite, lassitude, one episode of vomiting and worsening H/A.  Seen by PCP earlier, tx with IVF with worsening of sx.  Concern for viral meningitis and admitted for observation. Neuro consult with impression: Viral illness with mild meningeal involvement, now with severe pulmonary involvement with late onset. Pt developed shortness of breath. Dx with pneumonia. ID consult with Impression:  Viral syndrome, Post fraction complication of influenza vaccination, Bilateral pneumonia, Headache. Tx with abx and Tamiflu. Pt still with c/o h/a, but improving. Pt will f/u elevated transaminases as outpt.			Y		Y	6			Y	11/05/2008	11/12/2008	7	negative influenz a & B tests, spinal tap done normal results, blood cultures negative. Labs and Diagnostics:  CBC with WBCs 11.3-16, 92% neutrophils. 3.5% lymphs.  LP with 27 WBCs, 11 RBCs, protein 45.5.  CXR (+) for bilateral infiltrates. Brain MRI (+) for equivocal meningeal enhancement and L maxillary sinusitis. AST 109.  ALT 284. Blood glucose 194. Influenza A/B AG (-). Blood cx (-). CSF cx (-).	UNK	UNK		none	none. PMH: none.			1						1	Blood culture negative; Headache; Influenza serology negative; Meningitis viral; Musculoskeletal stiffness; Pneumonia; Pyrexia	FLU3~SANOFI PASTEUR~U2764AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0332701	11/18/2008	IL	21.0	21		F	11/18/2008	For the last 4 years that I have gotten the flu shot which was required for nursing school, I have gotten very ill. I have not had an anaphylaxis action yet, but I have had severe nausea & vomiting that lasted for several weeks after the vaccine was given. The public health nurse asked if I wore contacts because she knew thimerosal was an ingredient in both and I am allergic to all contact solutions except one that does not contain that ingredient so she believes i have an allergy to the thimerosal in the flu shot. This has caused me to miss class for several weeks each year after receiving the flu shot so because of all of this I was told to fill out this report. My nausea & vomiting is not just like the normal aches and feeling a little nauseous right after the shot which most people can have. This is more severe and lasts alot longer									N	10/31/2008	10/31/2008	0	Still nauseous & vomiting.	PUB	UNK	Dicyclomine, Toprol XL, Dessogen, Pepcid AC, Tramadol	none	Supraventricular Tachycardia, Acid Reflux, pain in Right side that the physicians do not know what causes it but I have had it for about 5 years			1						1	Nausea; Vomiting	FLU3~CSL LIMITED~01849111A~4~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0332703	11/18/2008	IL	1.3	1	.3	M	11/18/2008	Patient had shots at 10am, had tylenol throughout the day, at 8pm crawled up in my lap did not feel real warm and started to seize, pt seizure last 8-10 minutes from the time that we called the ems until they carried him to the ambulance.				Y					Y	11/06/2008	11/06/2008	0		UNK	UNK	singulair, pulmocort	no acute illness	reactive airway disease			1						1	Convulsion	DTAP~UNKNOWN MANUFACTURER~unknown~4~IM~UN~DTAP (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~unknown~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~UNKNOWN MANUFACTURER~unknown~1~IM~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0332705	11/18/2008	UT	26.0	26		M	11/18/2008	Within a couple hours of receiving the flumist vaccine, client experienced pain in the R upper jaw, he thought it was something related to a tooth.  Pain continued to get more intense and dental visit showed no problem with his teeth.  Pain continued to increase until it felt as though he had electric shocks in the upper R facial area.  Was diagnosed with a sinus infection , but antibiotics did not help.  Client was not sleeping and was in severe pain.  Was hospitalized for the pain and an MRI was done- diagnosed with trigeminal neuralgia and is now on Tegretol and ibuprofen.  The Tegretol has provided relief for the pain, but still has a dull ache.  12/01/08 MR received for DOS 1112-13/2008 with D/C DX:  Trigeminal Neuralgia. Pt initially presented to dentist with c/o R-sided upper teeth pain. No problems found but Rx Z-pak for possible sinus infection. Pain worsened, disturbing sleep. Pain is sharp, lancinating near R ear, cheek and eye. (+) maxillary tenderness. PE WNL except for severe pain and crying. Tx with pain meds and Tegretol with some improvement.				Y	Y	1			N	11/06/2008	11/06/2008	0	dental x-rays, MRI. Labs and Diagnostics:  Head MRI WNL.	UNK	UNK	None	None	Not known. PMH:  fx bones, ulnar collateral ligament repair, reactive lymph nodes-neck			1						1	Insomnia; Pain; Pain in jaw; Paraesthesia; Sinusitis; Trigeminal neuralgia; X-ray dental	FLUN3~MEDIMMUNE VACCINES, INC.~500545p~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0332708	11/18/2008	OK	1.83	1	.9	F	11/18/2008	Left leg swelling, warm, red knot started 12-18 hours after injections, lasted approximately 4 days, no treatment necessary just monitoring				Y					Y	10/07/2008	10/08/2008	1		PVT	PVT		Urinary Tract Infection				1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth	DTAP~SANOFI PASTEUR~C2955BA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT2782FA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB289AA~1~IM~LL~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0332710	11/18/2008	CA	9.0	9		F	11/18/2008	Received FluMist intranasally 11/14/2008 at 11:30 a.m.  Woke up at 5:00 a.m  on 11/17/2008 complaining of watery eyes, muscle aches, weakness, dizziness, abdominal pain, headache and fever.  These symptoms lasted all day into the evening.  The fever ranged from 101-103.  By 11/18/2008 fever had subsided, continued to feel weak.				Y					U	11/14/2008	11/17/2008	3	Strep test results negative. Urinalysis small amt of blood otherwise negative	PUB	PUB	none	no	none	anxiety and itching~Hep A (no brand name)~0~2.50~In Patient		1						1	Abdominal pain; Asthenia; Blood urine present; Dizziness; Headache; Lacrimation increased; Myalgia; Pyrexia; Streptococcal identification test negative; Urine analysis abnormal	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0332712	11/18/2008	CA	4.0	4		M	11/18/2008	Pediatric patient developed redness, warmth and mild tenderness in an area of about 6x4 Cm of the right deltoid about 24hrs post IM vaccination. Mother described unmeasured fever at home. Treatment included local ice packs and tylenol. Mother offered ibuprofen for fever one dose.				Y					U	11/17/2008	11/18/2008	1	Temp 97.2 F on 11-18-2008.  Important area of deltoid swelling as noted above.  No alteration of general status.	PVT	PUB		None	None			1						1	Body temperature; Injection site erythema; Injection site pain; Injection site warmth; Pyrexia	DTAP~SANOFI PASTEUR~C2955BA~4~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2808AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A1060~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0667X~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0332713	11/18/2008	IA	18.0	18		M	11/18/2008	Had flu shot on Tuesday 11/11/08.  Missed next day of school on 11/12 with nausea and vomiting.									Y	11/11/2008	11/12/2008	1		UNK	UNK	none	none	unknown			1						1	Nausea; Vomiting	FLU3~SANOFI PASTEUR~U2805AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332715	11/18/2008	WI	40.0	40		F	11/18/2008	Rec'd vaccine on 11.5.08. Started to experience muscle soreness on evening of 11.9.08.  11.10.08-fever, chills, nausea.  11.11.08-chills, flushed, loss of appetite, small red dots on body. 11.12.08-feeling okay, but developed dry cough.  11.13.08-fever, intense neck pain and body muscle aches. 11.14.08 - neck pain has radiated down to shoulders, intense body muscle aches. 11.15.08- 1 a.m. fever broke.  11.17.08 - large red warm splotches all over body.  As of 11.18.08--still loss of appetite, still intense shoulder pain/burning, still splotches, still dry cough. Dr appt scheduled for 11.19.08										11/05/2008	11/09/2008	4		UNK	PUB		Bulging disc - left side				1						1	Anorexia; Chills; Cough; Erythema; Flushing; Musculoskeletal pain; Myalgia; Nausea; Neck pain; Pyrexia; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA173AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332718	11/18/2008	KY	22.0	22		F	11/18/2008	Given Vaccines while pregnant. Having continuous symptoms of a flu. Have not fully recovered yet.									U	10/14/2008	10/15/2008	1		MIL	UNK		N/A	N/A			1						1	Drug exposure during pregnancy; Influenza like illness	ANTH~UNKNOWN MANUFACTURER~~UNK~IM~LA~ANTHRAX (NO BRAND NAME)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~UNKNOWN MANUFACTURER~~UNK~IM~LA~VARICELLA (NO BRAND NAME)~1	USA		Influenza
0332719	11/18/2008	WI	71.0	71		M	11/18/2008	Patients upper arm from elbow to shoulder became pink, warm to touch, and painful. He also had fever of 101 F. Symptoms started approximately 8 hours after injection.				Y					U	11/17/2008	11/17/2008	0	Cellulitis	PVT	UNK	ASA, HCTZ, Vit D, and Atenolol	Hyperthyroidism	hyperthyroidism, hypertension			1						1	Cellulitis; Injection site erythema; Injection site pain; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~u2761aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0979x~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332720	11/18/2008	TN	67.0	67		M	11/18/2008	Received Flu vaccination on 11/2 around 4PM in left arm. Following day experienced considerable sorness and tenderness at injection. Continued sorness and tenderness around injection site through the week. On 11/8 started to experience mild throbbing pain in left arm. On 11/9 started to feel tingling and numbness in fingers of left hand. On 11/10 pain started to spread to neck and right hand. Little sleep the night of 11/10 due to increase in pain intensity. Went to health center at 9:45AM om 10/11. Saw PA-C. Said to put heat on it. Applied heat to injection site and hands. Did help. On 11/12 noticed rash had broken out on abdomen. Rash did not burn or hurt but did have little pustles. On 11/13 rash expanded to lesser degree to back and hands. Pain intensity increased in left arm and to right hand. Numbness and tingling sensation increased in both hands. Dr. was puzzled. Symptoms appeared to indicate Shingles but rash did not conform to standard pattern. Pattern looked more like an allergic reaction. Placed on 500MG Famciclovir (3X) for 7 days and steroids for pain. On 11/18 rash has shrunk. Now evident only on abdomen. Rash still not burning or sore to touch. Arm pain has subsided. Still some numbness and tingling in the left hand. Right wrist skin surface near thumb still numb with some tingling.										11/02/2008	11/08/2008	6		UNK	UNK				~Influenza (Seasonal) (no brand name)~~0.00~In Patient		1						1	Hypersensitivity; Hypoaesthesia; Injection site pain; Neck pain; Pain; Pain in extremity; Paraesthesia; Rash; Rash pustular; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332722	11/18/2008	TX	73.0	73		M	11/18/2008	Within 15 of shot became hot/flush. Head became dizzy. Laid down & was better.  Each time I got up my head was very bad - dizzy, I guess. I threw up in the afternoon (rec'd flu shot at 10 am 11-17-08).  Went to doctor, everything ok, including an EKG. Lasted all day.  Couldn't eat. To bed at 10:30 pm & slept ok. Next morning, pretty much ok. Some residual headache.				Y					Y	11/17/2008	11/17/2008	0		PUB	PUB	Plavix, Virorin	None	None	None~ ()~NULL~~In Patient		1						1	Anorexia; Dizziness; Electrocardiogram normal; Headache; Hot flush; Immediate post-injection reaction; Vomiting	FLUX~UNKNOWN MANUFACTURER~Inactivated~2~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0332724	11/18/2008	UT	86.0	86		F	11/18/2008	she presneted 10/23 for a blood pressure check up and in the course of that we did an annual flu shot for her. See the flu shot note:        10/23/08 The following questions were answered by the patient: Are you currently ill with a moderate or severe illness? No Temperature: __ Are you allergic to eggs or egg products? No Have you ever been paralyzed by Guillain Barre Syndrome? No Have you ever had a severe allergic reaction after getting the flu vaccine? (difficulty breathing, aiway swelling, hives, etc.) No Patient was given the opportunity to ask questions prior to immunization and have them answered to their satisfaction: _Yes Manufacturer: Aventis Lot #: U2805AA Expiration Date: 06/30/2009 Preservative Free _No Vaccine information sheet given: Yes VIS Pub. Date: 07/24/08 Dose: 0.5 ml Site: left deltoid  She then reproted on 10/31 with swelling in hands and feet and rash. It looked like allergic reaction. she was not ill so we treated her as an out patient. she called a few days later and was getting worse. I had her admitted to hospital. I have not received a formal report. One of the diagnosis that was on the top of the list was influenza vaccine vasculitis. she was not getting better. The Dr. that was caring for her reported that her dau, a hospice nurse talked to her about what was going on and patient decieded to not have any more needle pokes or evaluation. She was sent to nursing home and died the next day. 12/29/08-records received for DOS 11/3-11/12/08-DC DX: likely vasculitis. acute renal failure, resolving. Presented with C/O weakness, seen 3 days prior with swelling in fingertips and lower extremities. Hyperkalemic. Dehydrated. Hyponatremia. Purpura of feet and lower extremities. 11/21/08 Death certificate states COD as acute renal failure with vasculitis & immunologic reaction as contributing factors.	Y	11/13/2008			Y	9			N	10/23/2008	10/23/2008	0		UNK	UNK	liptor, spironolactone, lanoxin, allopurinol, macrobid, plaquinil, hydrochlorthiazide, quinapril		Rheumatoid arthritis, osteoperois, gout, chronic UTI, hyperlipid, chf. 12/29/08-records received-PMH: rheumatoid arthritis. status post mitral valvle replacement. status post left mastectomy for breast cancer. chronic UTI. osteoporosis.			1						1	Death; Hypersensitivity; Oedema peripheral; Rash; Vasculitis	FLU3~SANOFI PASTEUR~U2805AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0332725	11/18/2008	NH	1.25	1	.3	F	11/18/2008	Very red at site of injection. Have never had any adverse reaction from any shots for first yr,  had two flu shots last yr with no problem.  Bruising and large bump under skin at site of injection. Continues to have medium bump under skin where she was given the shot.  Two other shots given that day with no other problems reported or noted.									U	10/30/2008	10/30/2008	0		PVT	UNK	floride	none	none			1						1	Injection site erythema; Injection site haematoma; Injection site mass	FLUX~UNKNOWN MANUFACTURER~~2~~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332726	11/18/2008	TN	55.0	55		F	11/18/2008	IMMEDIATELY AFTER SHOT THERE WAS SWELLING AND A BRUISE THAT LASTED FOR 2 WEEKS. WHEN THE SWELLING AND BRUISE BEGIN TO GO AWAY PAIN BEGIN IN THE JOINTS OF MY KNEES, SHOULDERS, ELBOWS, AND HANDS ALONG WITH SWELLING SO SEVERE I CANNOT BEND MY FINGERS OR RAISE MY ARMS ABOVE MY SHOULDERS IN THE MORNINGS. I SAW MY DOCTOR TWICE FOR THESE PROBLEMS BEFORE BLACKING OUT AND FALLING. I WAS HOSPITALIZATED OVERNIGHT. ALL TESTS AND SCANS HAVE COME BACK COMPLETELY NORMAL. THE DOCTOR THINKS THE VIRUS HAS SETTLED IN MY JOINTS. THIS PAIN HAS BEEN CONSTANT AND ONGOING FOR 3 WEEK.  12/5/08 Reviewed hospital medical records of 11/13-11/14/2008. FINAL DX: syncope, probable vasovagal; facial contusion; severe myalgia w/muscle weakness. Records reveal patient experienced syncope in shower, fall, unconsciousness, facial contusions w/nasal laceration & leg pain x 1 day.  Also complaining of joint aching, muscle aching since 10/28.  Had been tx by PCP as outpatient w/antibiotics & steroids which helped but when steroids tapered, symptoms recurred.  No further episodes while hospitalized.  D/C to home w/referral to neuro as outpatient.				Y	Y	1			Y	10/14/2008	10/28/2008	14	[[address]]head, carotid artery duplex study all WNL.	UNK	UNK	MULTIVITAMIN, CALCIUM, FISH OIL, AND BABY ASPIRIN	NONE	NONE  PMH: family hx: breast cancer, DM, heart disease & HTN			1						1	Contusion; Fall; Hypokinesia; Immediate post-injection reaction; Loss of consciousness; Swelling; Viral infection	FLU3~SANOFI PASTEUR~U2746AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0332730	11/18/2008	MA	31.0	31		F	11/18/2008	Received vaccine on 11/13/08 and developed itchy rash that spread on arms, legs, face. Evaluated on 11/17/08 and dx with chicken pox.			Y						N	11/13/2008	11/15/2008	2		PVT	PVT		None	None			1						1	Rash; Rash pruritic; Varicella	FLU3~SANOFI PASTEUR~U42786BA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0131X~1~SC~UN~VARICELLA (VARIVAX)~1	USA	Life Threatening	Influenza
0332732	11/18/2008	IA	2.0	2	.1	M	11/18/2008	Hives within 48 hour of administering the flu mist. No fever noted. BENADRYL recommended. No reaction to injectable flu 1 year ago.									Y	11/14/2008	11/15/2008	1	None	PVT	PVT	None	None	amoxicillin			1						1	No reaction on previous exposure to drug; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500570P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0332733	11/18/2008	CO	31.0	31		M	11/18/2008	On 11/18/2008 patient called and stated she was having tooth, stomach, shoulder and elbow pain, she was concerned that this was related to her vaccination. We have tried to contact her again but have not gotten a response.									U	11/15/2008				OTH	PVT	Vicodin	Unknown	Unknown			1						1	Abdominal pain upper; Arthralgia; Musculoskeletal pain; Toothache	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332734	11/18/2008	CO	78.0	78		M	11/14/2008	Instantly caused deep pain during injection									Y	11/12/2008	11/12/2008	0		OTH	PVT						1						1	Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89971~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332735	11/18/2008	MN	27.0	27		M	11/18/2008	After receiving flu vaccine pt walked over to recovery after pt stated he didn't feel very well - placed head between knees. B/P - 127/70, P - 70. Pt then laid flat for a few minutes without drinking anything. Placed  in W/C and brought to clinic for MD check when he felt well and was dismissed. He noted everyone in his family gets sick with shots.									Y	11/18/2008	11/18/2008	0	B/P - 127/70; P - 70	OTH	PVT						1						1	Familial risk factor; Malaise	FLU3~SANOFI PASTEUR~U2769AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332736	11/18/2008	CA	22.0	22		U		Right after vaccination, pt experiences soreness in left arm (whole left arm), tingly feeling in left arm. patchy light rash on arm went away after about 10 min. and appears on left palm.									Y	11/13/2008	11/13/2008	0		OTH	OTH						1						1	Pain in extremity; Paraesthesia; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332738	11/18/2008	ND	51.0	51		F	11/04/2008	Pt had flu shot 10/29/08 at 8:30AM, by 12:30pm she developed symptoms of headache, muscle aches, fever (101 6/0), fatigue.				Y					Y	10/29/2008	10/29/2008	0	Influenza A+B test - 0 CBC-WBC 10.9, HGB 14.8	PUB	PVT	Zinc, MTV,Calcium, Glucosamine, Aspirin					1						1	Fatigue; Full blood count; Haemoglobin normal; Headache; Influenza serology negative; Myalgia; Pyrexia; White blood cell count increased	FLU3~SANOFI PASTEUR~U2810AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332739	11/18/2008	WI				F		Persistent deltoid pain esp. w/abduction. Onset w/vaccination									N	10/28/2008	10/28/2008	0		PVT	UNK		NONE				1						1	Myalgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA366BA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0332728	11/19/2008	WA	58.0	58		M	11/18/2008	light headed shortly after shot, had nap with odd dreams woke up went to sleep three hours later. about 4 am i was awake but could not move at all.all i could do is make small sounds untill someone could shake me and the rest of me was fine.									U	11/17/2008	11/17/2008	0		UNK	UNK						1						1	Abnormal dreams; Dizziness; Mobility decreased	FLU3~SANOFI PASTEUR~u2758aa~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332729	11/19/2008	CA	35.0	35		F	11/19/2008	Two days after my flu shot I broke out in a severe rash on my legs. It is raised red bumps that itch severely. I also broke out with pustules (pencil eraser to dime-sized) on my back and stomach. Other than the flu shot there were no changes to my diet or medication during this time, so I drew the conclusion that it must be an adverse reaction to the vaccination.				Y					N	11/15/2008	11/17/2008	2	I am going to the doctor to receive a shot to counteract the rashes. For the first day I took Benadryl to reduce the itching.	UNK	PVT	Synthroid, Kariva, Bupropion, Amitriptilne	No	I am allergic to nickel. I am also allergic to the drugs Cipro, Keflex and Toradol.			1						1	Pruritus; Rash; Rash pustular	FLU3~SANOFI PASTEUR~49281-0382-15~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332754	11/19/2008	CA	54.0	54		F	11/15/2008	Left deltoid, erythematous raised patch below site. Contusion above site. Large amt swelling into upper forearm. Lymphadenopathy, axilla and tonsillar.				Y					U	11/03/2008	11/03/2008	0		PUB	UNK		None	HTN(hypertension)			1						1	Contusion; Injection site erythema; Injection site haematoma; Lymphadenopathy; Swelling	FLU3~SANOFI PASTEUR~U2512AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C299413A~UNK~UN~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0332757	11/19/2008	PA	41.0			F	11/14/2008	Patient received the Influenza vaccine on 10/3/08. Reported that about 2 or 3 days later, developed cough and sinusitis. Symptoms resolved in slightly over 1 week. Symptom: wheeze.														UNK	UNK						1						1	Cough; Sinusitis; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332760	11/19/2008	PA	52.0	41		F	11/14/2008	Patient received influenza vaccine on 10/1/08. 15 minutes after the injection, patient reported her lip went numb and her jaw went numb. Vitals were checked and were WNL. Symptoms resolved. No other vaccines in past month and never had a reaction to the influenza vaccine.									Y	10/01/2008	10/01/2008	0	Vitals checked 10/1/08 and were WNL.	OTH	OTH						1						1	Hypoaesthesia; Hypoaesthesia oral; No reaction on previous exposure to drug	FLU3~GLAXOSMITHKLINE BIOLOGICALS~GSKAFLULA171AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332761	11/19/2008	FL	53.0	53		M	11/17/2008	Previously healthy 53 y/o received influenza vaccine at work around Nov. 5, 2008.  This individual has no medical problems and takes no meds.  Manufacturer was Novartis, Lot number 88637.  10 days later, the patient developed Shingles - Herpes Zoster - involving the C8 dermatome on the left arm/hand.  The Zoster appears to be mild in intensity.  Placed on Valtrex 1 gm tid x 7 days on 11/16/2008.										11/15/2008	11/15/2008	0	None	UNK	UNK			None			1						1	Herpes zoster	FLUX~UNKNOWN MANUFACTURER~88637~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332762	11/19/2008	OR	36.0	36		M	11/19/2008	Edema, Erythema, warm to touch, tenderness to palp. Numbness at injection site, pain to upper right arm and back. In conjunction with Lymphadenitis.									U	11/18/2008	11/18/2008	0		OTH	OTH	Ibuprofen	Migraine headaches	Latex; Iodine; Codine; APAP;chocolate; Nuts; Tomatoes			1						1	Back pain; Erythema; Injection site anaesthesia; Lymphadenitis; Oedema; Pain in extremity; Skin warm; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~087X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332763	11/19/2008	WI	47.0	47		M	11/17/2008	Exacerbation of rebif side effects- specifically chills.									Y	10/20/2008	10/20/2008	0	None	PVT	PVT		None	Multiple Sclerosis	~Influenza (Seasonal) (no brand name)~~46.00~In Patient		1						1	Chills	FLU3~SANOFI PASTEUR~U2740AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332764	11/19/2008	GA	64.0	64		F	11/19/2008	Pt had swelling, erythema and induration fo (R) upper arm, from mid deltoid approx 24 hrs after immunization. Had reduced some when seen by provider approx 36 hrs after immun. Verified Rxn to pt- suggested cool compresses and dose of Benadryl 25mg PO ( in addition to Allegra BID that pt normally takes). Lungs clear bilaterally, heart RRR, neuro intact. No musculoskeletal weakness. Pt will RTC if not improving.  Pt had previous sinusitis.   tx with Biaxin x 10 days- finished 10/31/08.									U	11/17/2008	11/18/2008	1		OTH	PVT	Diovan; Lipitor; Premarin; Flonase; Verapamil' Allegra (bid)	None	Sulfa; Penicillin's; Avalide; High blood pressure; High cholesterol.			1						1	Erythema; Induration; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89124~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0858U~2~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332765	11/19/2008	NY	63.0	63		M	11/19/2008	Red bumps on both arms and on head.				Y					U	11/05/2008	11/05/2008	0	referred to allergist	PVT	PVT	None	None	None			1						1	Erythema; Rash papular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA193AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0619X~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332766	11/19/2008	NJ	28.0	28		F	11/19/2008	Large redden area behind left triceps. With welping radiating on inner portion of arm. Arm redness 3 1/2in x 4in hard warm to touch. VS=97.5- 117/80-82-18									Y	11/17/2008			None	MIL	MIL	None	None	None			1						1	Erythema; Feeling hot; Induration; Urticaria	ANTH~UNKNOWN MANUFACTURER~#FAV149~5~SC~RA~ANTHRAX (NO BRAND NAME)~1|FLUN3~MEDIMMUNE VACCINES, INC.~01449111A~6~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|TDAP~SANOFI PASTEUR~C2994BA~1~IM~UN~TDAP (ADACEL)~1	USA		Influenza
0332767	11/19/2008	WI	6.0	6		M	11/13/2008	(L) upper arm swelling, warmth and redness from above elbow to arm pit. Started at 24hrs after vaccine and progressed. We are seeing pt as 36 hrs after vaccine admin. Has full range of motion, normal strength, just slight ache pain. Recommended Ibuprofen on second day of symptoms.									U	11/11/2008	11/12/2008	1	None	PVT	PUB	Flovent inhaler; Albuterol inhaler	None	Moderate Persistent asthma			1						1	Erythema; Feeling hot; Oedema peripheral; Pain	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B085AA~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2848AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332768	11/19/2008	MI	43.0	43		F	11/19/2008	Generalized raised red rash began approx 24hrs after vaccination. Personal physician administrated steroid injections.				Y					Y	11/14/2008	11/15/2008	1	None	OTH	PVT		None	Allergies-mold; mildew; cats; dust mites; food preservative.			1						1	Rash erythematous; Rash generalised	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89685~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0332769	11/19/2008	DC	73.0	73		F	11/19/2008	Patient begin to feel tired, achey and had a headache, described her left arm as showing angry red band around her arm. Days later the injection site became flaky at the injection site. Arm swelling size of baseball									Y	10/16/2008	10/17/2008	1	None	OTH	OTH	Unknown	None	Unknown			1						1	Erythema; Fatigue; Headache; Injection site dryness; Oedema peripheral; Pain; Skin exfoliation	FLU3~SANOFI PASTEUR~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~08030~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332770	11/19/2008	NH	46.0	46		F	11/19/2008	Vaccine burned upon administration. Following morning (L) deltoid area was itchy, red, hot and swollen and continued this way x3-4 days. Then became itchy & red x2-3 days. Then resolved.									Y	11/07/2008	11/08/2008	1		OTH	PVT						1						1	Injection site erythema; Injection site irritation; Injection site pruritus; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2751AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332771	11/19/2008	NH	56.0	56		F	11/19/2008	Received FLUZONE (L) deltoid 11/06/08 @ 4PM. Over a period of 2 hours felt vaccine move from upper arm to shoulder to cheek. Following morning cheek swollen and mouth full of canker sores. Saw MD 11/7/08. Advised not to have FLUZONE again.				Y					Y	11/06/2008	11/06/2008	0		OTH	PVT			Percodan; Meclomen; Toradol			1						1	Aphthous stomatitis; Oedema mouth	FLU3~SANOFI PASTEUR~U2751AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332772	11/19/2008	NH	50.0	50		M	11/18/2008	5 1/2 hrs after injection c/o  itchy eyes; took BENADRYL .25 mg. Following morning woke with eyes swollen shut. Called MD who advised to take 50 mg BENADRYL @ 9A-1P-6P. AT 6 pm, lips began to swell + burn.  Developed rash on face + groin. Went to ER + treated with IV BENADRYL + Steroids. 3 days following vaccine, but (L) eye + cheek still rashy + slightly swollen. NB: Recalls during an environmental site test on 11/13. Friend/calleague has similar symptoms.				Y					U	11/14/2008	11/14/2008	0	None	OTH	PVT	Thyroid; LIPITOR; VALTREX		Sulfa; yellow jacket strings; seasonal/ environmental allergies.			1						1	Burning sensation; Eye pruritus; Eye swelling; Lip swelling; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~E7924~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0332773	11/19/2008	CT	41.0	41		M	11/18/2008	10/31/08 Received FLUVIRUS on 11/11/08 noticed bilateral lower extremity muscle pain. 11/12/08 additional muscle pain in upper left extremities. 11/13/08 felt feverish, chills, muscle pain continue. 11/14/08 no fever/chills but had significant muscle pain in arms and legs, called PMD, Doctor instructed to discontinue PRAVASTATIN 40mg and take 2 ALEVE every 12 hrs. 11/15/08 muscle pain decreased with ALEVE but developed severe weakness hands/finger. Seen by PMD 11/16/08.				Y					N	10/31/2008	11/11/2008	11	Blood work done by PMD on 11/16/08	OTH	PVT	PRAVASTATIN 40 mg		HYPER CHOLESTEREMIA			1						1	Blood test; Chills; Muscular weakness; Myalgia; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89973~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0332776	11/19/2008	CT	22.0	22		F	11/19/2008	Patient received flu shot 9:30 AM.  States within hours had rash, upset stomach, fever.  Patient called hospital, spoke with someone on phone - patient seeing doctor, taking Amoxicillin for ear infection.  No fever - patient seen at hospital 11/18/08 2:10 pm.  Patient will follow up with primary MD if symptoms reoccur or if she does not continue to improve.				Y					Y	11/17/2008	11/17/2008	0	None	PVT	PVT	Amoxicillin aciphax; Loestrin; Zixol	Ear infection				1						1	Ear infection; Pyrexia; Rash; Stomach discomfort	FLU3~CSL LIMITED~01349111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0332778	11/19/2008	PA	44.0			F	11/13/2008	Received vaccine in (L) arm. Could not lift arm subsequently. Reports deep pain & hyperesthesias. Shoulder exam normal. Neuro exam hyperreflexic & increased/hyper sensory exam.				Y					N				EMG ordered	PVT	PVT		Leg pain from sciatica	Indocin Allergy; GERD; IBS			1						1	Hyperaesthesia; Hyperreflexia; Injected limb mobility decreased; Pain in extremity; Sensory disturbance	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89987~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0332781	11/19/2008	WV	59.0	59		M	11/19/2008	Patient reports he received flu vaccination at his place of business at 2:15 pm on Monday,  11/03/2008. The same evening at 8:00 pm his arm developed a softball size hive which he described as being raised, red, swollen, hard, itching, and warm to touch at site of administration (LD). Hr reports that when he woke up the following morning at 7:00 am on Tuesday, ll/4 his arm was normal. On Tuesday evening (11/4) at 9:00  pm he developed a tennis ball. sized hive on his mid back area that progressively spread to his entire back and a large area of both thighs. He denied any SOB or airway obstruction. He took 2 OTC Benedryl tablets at 3:00 am and states when he awoke the following morning on Wednesday, 11/5 at 7:00 am the hives had resolved. He had carpel tunnel surgery on Thursday, Nov 6 on his R wrist and reports no episode of hives on the day of surgery, but on the same evening (Thursday) he again developed  a hive on his outer left thigh which he described as golf ball in size, raised, warm and itchy. He again took 2 OTC Benedryl tablets. On Friday, Nov. 7 at 7 am he reports having hives on both buttocks and thighs which progressively spread to both of his entire thighs and to back of both knees. By 12:15 on Friday, Nov. 7 the hives had resolved.I checked back with him on Wednesday, Nov. 12 and he reports no further problems since Friday, Nov. 7. He reports he has received the flu vaccine annually for the last 10 years without adverse effects.									Y	11/03/2008	11/03/2008	0		PUB	PVT	Nabumetone, Lipitor, atenolol, Zetia,Lexapro,MVI, Estra C	None reported	He states allergy to Oxyprozone, a pain med. Adverse effect on 2 prior occassions was one episode of hives after taking med. He believes he may have some mild allergies to foods, but has never been diagnosed.			1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Injection site urticaria; Injection site warmth; Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA357CA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0332782	11/19/2008	CO	22.0	21		F	11/19/2008	Was contacted by employee's mother who said employee had had a migraine headache for one week post influenza vaccination. Employee does not have a history of migraines.									Y	11/10/2008	11/10/2008	0	none	PUB	PVT	none	none noted	none			1						1	Migraine	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88117 6P~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332783	11/19/2008	OH	84.0	84		F	11/19/2008	Her physician called to report that her flu shot resulted in the inability to move her entire arm, but the condition is improving.  Her arm was very sore and tender and the doctor thought maybe the injection had been given too high on her arm.				Y					Y	11/06/2008	11/06/2008	0	none that I am aware of	UNK	UNK						1						1	Injected limb mobility decreased; Pain in extremity; Tenderness	FLU3~SANOFI PASTEUR~U2839AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332785	11/19/2008	PA	25.0	25		F	11/13/2008	Patient received influenza vaccine 10/24/08.  Patient called 11/12/08 stating he has been experiencing numbness and tingling in left arm and arm since receiving the vaccine. Spoke with physician who instucted patient to be seen at student health. Patient reports he will go 11/14/08 at noon. Message was left for patient on Fri 11/14 in the afternoon, Sat 11/15 and Monday 11/16.  As of Wed 11/17 patient has not called back to notify us of outcome.				Y					U	10/24/2008	11/12/2008	19		PUB	UNK		None				1						1	Hypoaesthesia; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA350AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0332788	11/19/2008	CO	42.0	42		F	11/19/2008	Employee had extreme fatigue, malaise for one week after receiving annual influenza vaccine. Also reported left arm where vaccine was given was so sore that she was unable to sleep on that side.									Y	10/28/2008	10/28/2008	0	none	PUB	PVT	none known	none noted	none known			1						1	Fatigue; Injection site pain; Malaise	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88117 6P~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332789	11/19/2008	VA	58.0	58		F	11/19/2008	At about 3 pm the day of vaccination, patient began to cough in response to a tickling sensation in throat.  The cough got progressively worse ove the enxt 2 hours in response to what felt like a river of drainage.  Patient took Nyquil Cough to sleep & felt better the next am.									Y	11/03/2008	11/03/2008	0		UNK	UNK		none	none		VA08019	1						1	Cough; Throat irritation	FLU3~SANOFI PASTEUR~U2805AA~7+~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332790	11/19/2008	CA	55.0			F	11/19/2008	2-3 hrs after flulaval injection, client broke out in itchy, red rash with welts abdomen and back. Speads to face. MD called. Benadrl 50 mg IM given/LD. Symptoms worsening.To ER, private car driven by school nurse. No throat or breathing difficulties. DC'd home at 6 PM. Rash cleared by AM Sat 10/11/08.				Y					Y	10/10/2008	10/10/2008	0		UNK	UNK						1						1	Pruritus; Rash; Rash erythematous; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~4~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0332793	11/19/2008	MA	59.0	59		F	11/19/2008	Generalized body rash, diagnosed on 11/17 by dermatologist as erythema multiforme. Rash appeared on back approximately 24 hours after vaccination and spread to entire body, persisting as of this writing (11/19). Rash is flat and itchy. Also experienced low grade fever and muscle aches that began overnight and  subsided within 24 hours of vaccination.				Y					N	11/12/2008	11/13/2008	1	None	UNK	UNK	Levoxyl, Atenolol	None	None			1						1	Erythema multiforme; Myalgia; Pruritus; Pyrexia; Rash generalised	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0332795	11/19/2008	NJ	65.0	65		F	11/11/2008	Pt. stated left upper arm became red, swollen, painful and hot a few hours after Pneumonia vaccine given.  Also, had chills, body aches and fever of 100.2 that evening.  On 11/11, she felt slightly better, but arm still swollen, red and painful, but no fever, chills or body aches. Follow up phone call on 11/17, husband stated that she was completely recovered.									Y	11/10/2008	11/10/2008	0		PUB	PVT	Crestor; B/P med.? name	None	No known allergies; Hx. HTN, Hypercholesterolemia			1						1	Chills; Erythema; Oedema peripheral; Pain; Pain in extremity; Pyrexia; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA176AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0868X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332797	11/19/2008	CA	46.0	46		F	11/19/2008	Given Flu shot 11/12/2008.  Next day a rash appeared on left upper thigh.  Rash spread over the next few days and now is on lower abdomen, legs and arms.  Rash is fine, red, raised and very itchy.									N	11/12/2008	11/13/2008	1		PVT	PVT		none	none			1						1	Pruritus; Rash erythematous	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA357BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0332798	11/19/2008	NC	5.0	5		M	11/19/2008	Patient's arm at the site of the injection is swollen and red from the top of his shoulder to his elbow.  Patient got the shot on 11/17/08 at 3:15pm.  He tested positive for strep that same day at 8:00am.  He took his first dose of amoxicillin at 9:30am.									U	11/17/2008	11/18/2008	1		UNK	UNK		strep throat				1						1	Injection site erythema; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332799	11/19/2008	CA	3.0	3		F	11/19/2008	ADMINISTERED ADULT ONLY ON FLU									U	11/06/2008	11/06/2008	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Inappropriate schedule of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332800	11/19/2008	AZ	85.0	85		F	11/19/2008	The same day as receiving an influenza injection, the patient started with fever, cough and body aches that lasted 1 week.  She did not complain of runny nose or sore throat.  All symptoms resolved without medical treatment.  Patient was concerned that there was a live componant to the vaccine and was reassured by myself.									Y	10/27/2008	10/27/2008	0		PUB	PUB		None reported.				1						1	Cough; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2766AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332801	11/19/2008	OK	58.0	58		F	11/19/2008	Was called to room where client was found to be  clammy, flushed, then turned white as a sheet, had n/v, shortness of breath, and difficulty breathing with in 10 to 15 minutes of the time the injections were given. Advised to call 911. Flu and pneumonia immunizations were given at the same time.  Epinephrine 1:1000 0.50 ml given IM and Benadryl 50mg (1.0ml) given IM. 12/19/08-records received-presented to Ed with C/O nausea and vomiting on 11/13/08. C/O pain in subxiphoid area of stomach, crampy. DX:adverse reaction to flu shot. Acute nausea and vomiting.			Y	Y					Y	11/13/2008	11/13/2008	0		UNK	UNK		Denied any illness	None reported 12/19/08-records received-PMH:hypertension.			1						1	Cold sweat; Dyspnoea; Flushing; Nausea; Pallor; Vomiting	FLU3~SANOFI PASTEUR~U2811AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0622X~2~IM~LL~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening	Influenza
0332802	11/19/2008	MI	7.0	7		F	11/19/2008	Patient received VZV immunization on 10/21/08.  On 11/17/08 small papules began to appear over legs, arms, and trunk.  Fever onset on 11/18/08 at home (97.8 temperature here today). Patient has 50 or less scattered lesions.  (Mom states that years ago, two siblings both developed rash after receiving VZV immunization #1, children now age 9 and 12).										10/21/2008	11/17/2008	27	none	PVT	PUB	none known	None	None	Rash~Varicella (no brand name)~1~~In Sibling1|Rash~Varicella (no brand name)~1~~In Sibling2		1						1	Pyrexia; Rash papular	FLU3~SANOFI PASTEUR~U2764AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1185X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0332803	11/19/2008	NH	71.0	71		M	11/19/2008	Received Pneumovax 10 AM 11/18/08.  Complained of some immediate discomfort.  Noted some minor warmth and erythema at the injection site the morning of 11/19/08 which worsened over the day and by the time of evaluation at 5 PM had fairly extensive erythema over the right deltoid and a large, oval area of erythema and warmth over the triceps region.  Low grade fever of 100.2 (temporal) noted but no other systemic symptoms or signs.  Given Solumedrol 125 mg IM and Rocephin 1 gm IM and given prescriptions for Prednisone 20 mg 3 tabs daily x 3 days and Keflex 500 mg 1 tab qid x 7 days to start 11/20/08.									U	11/18/2008	11/19/2008	1	None	UNK	UNK	Zocor, Diovan, Tenormin, Nexium, Nitrostat, Singulair, Viagra, Aspirin, Veramyst	None	ASCVD, HTN, Hypercholesterolemia, allergic to Penicillin			1						1	Discomfort; Erythema; Injection site erythema; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U2811AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0803U~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332806	11/19/2008	CA	4.0	4		F	11/19/2008	One week after the flumist, she began to have simple movements of mouth and fingers -- aka tics.  Eventually hospitalized to evaluate as tics became more complex involving arms/legs.  MRI, EEG, blood tests all normal.  Followed by neurology and undergoing workup.  Also had recent stress and fungal infection at the same time.  Previous history of hospitalization due to dehydration and cramping after flu-like virus. 12/10/08-records received for DOS 11/9/08- DC DX: Complex Tics. Vaginal yeast infection. Presented with recent onset of abnormal facial, shoulder, hand and feet movements. C/O itching of genital area. Observed complex movements involving hands and feet and some lip smacking.				Y	Y	2			U	10/21/2008	11/03/2008	13	MRI, EEG, Blood tests - cbc, cmp, drug screen, aso titer normal 12/10/08-records received-MRI negative. EEG no seizures noted.	UNK	UNK	none	none	history of febrile seizure			1						1	Blood test normal; Drug screen negative; Electroencephalogram normal; Full blood count normal; Metabolic function test; Nuclear magnetic resonance imaging normal; Streptococcal identification test negative; Stress; Tic	FLUN3~MEDIMMUNE VACCINES, INC.~500560P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0332808	11/19/2008	AZ	33.0	33		M	11/19/2008	mild soreness at injection site that resolved within 1-2 days of vaccination. approximately 2 weeks later, noticed pain/soreness in right upper arm. thought may have pulled muscle with exercise. continued to be sore with right arm abduction and deep palpation. noticed right deltoid weakness on 11/15/08 when tried to do bench press and push ups. didn't notice weakness in deltoid muscles prior. weakness slowly improving but not completely resolved.									N	09/30/2008	10/14/2008	14	n/a	PVT	UNK		none	seasonal allergies, allergy to niaspan			1						1	Asthenia; Injection site pain; Pain in extremity	FLU3~SANOFI PASTEUR~u2784ka~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332815	11/19/2008	IL	1.0	1	.0	F	11/19/2008	1 year shots administered approx 1 PM 11/18/07. URI symptoms, weak prior, resolved. Parents brought child back to clinic 11/19/08 with fever 104.5. Onset of fever approx 5-6 PM on 11/18/08. Non-focal exam on presentation with exception of fever. Tachycardia 190-200 BPM. Tachycardia resolved with fever reduction. 11/20/08-records received for DOS 11/19/08-presented to acute care clinic with fever x1 day. Received vaccines around 2pm and at 6-7 pm developed high fevers max of 104 at home. Decreased PO intake since last night. Three episodes of emesis. Fussiness, tachycardia, drenching sweats, increased sleepiness and nasal drip, rhinorrhea, constipation. An incident like this has never happened before with other vaccinations. URI.				Y	Y	1			U	11/18/2008	11/18/2008	0	Urine culture; CBC; chemistry ; blood culture on 11/19/08 results pending 11/20/08-records received-WBC 22.0, CRP 4.9, absolute neutrophil 13.9.	PUB	PUB	Acetaminophen	none	none			1						1	Blood culture; Culture urine; Full blood count; Laboratory test; Pyrexia; Tachycardia	FLU3~SANOFI PASTEUR~U2829AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~4037X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~D03125~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~4037x~1~IM~RL~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0332816	11/19/2008	SD	53.0	53		F	11/19/2008	From 10/30/2008 to 11/18/2008 - severe joint pain- head to toe.  No fever hurt to walk. Resolved 11/18/2008 on own- No missed work.									Y	10/29/2008	10/30/2008	1		PUB	OTH	TOPREL for tachycardia;  CELEXA for depression (has been on years)	None				1						1	Arthralgia; Gait disturbance	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332817	11/19/2008	SD	52.0	52		M	11/19/2008	From 10/30/2008 to 11/18/2008- severe joint pain- head to toe.  No fever- painful to even walk.  Resolved on own 11/18/2008 AM.  No missed work.									Y	10/29/2008	10/30/2008	1		PUB	OTH	On blood pressure meds - but have been on them several years	None	Hypertension			1						1	Arthralgia; Gait disturbance	FLU3~SANOFI PASTEUR~02760AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332818	11/19/2008	CA	36.0	36		F	11/19/2008	After receiving the full vaccine the patient experienced increased pain, swelling and numbness to right arm. Pt was seen through the ER-given IM-Benadryl and PO-Vicodin. Pt did have a fever at the time of ER visit.				Y					Y	11/13/2008	11/13/2008	0	NONE	PVT	OTH	NONE	NONE	NONE			1						1	Hypoaesthesia; Oedema peripheral; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U2789AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2731AA~1~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0332819	11/19/2008	FL	55.0	55		M	11/19/2008	Patient came in with complaints of a pain under right armpit, began at 10:00AM. Pain is a 3-4 on a 1-10 pain scale. No swelling, redness or lymphadema noted. Patient instructed to take either Tylenol or Ibuprofen if needed. Call with any problems.										11/18/2008	11/19/2008	1		OTH	OTH						1						1	Axillary pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLA166AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0868X~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332820	11/19/2008	ID	4.0	4		F	11/17/2008	Rt thigh 5.5 x 3.5 cm erythema- mild tenderness increased warmer. Lt thigh -1 circle.									U	11/13/2008	11/14/2008	1		PVT	PVT	None	None				1						1	Injection site erythema; Injection site pain; Injection site warmth	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B074AA~5~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2800DA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB216AA~1~IM~RL~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~A1060~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0666X~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1188X~2~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0332821	11/19/2008	WA	57.0	57		F	11/19/2008	After about 15-20 min of getting a flu shot, she felt dizzy & light headed.  She sat down on the chair and experienced tingling sensation all over her body.  Tremor in her hands & drowsiness.  I called 911 and have medics check her out as precautionary measure.  Later, they took her to the hospital for further tests.				Y					Y	11/19/2008	11/19/2008	0	Unknown.  Possible delayed reaction to Flu vaccine	OTH	OTH	Posamax-D Naproxen	None	Caffeine allergy			1						1	Dizziness; Paraesthesia; Somnolence; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0332824	11/19/2008	NY	63.0	63		F	11/19/2008	TC from patient 4:45 pm, 11/18/2008. States received AFLURIA on 11/17/2008 off site clinic. Complains of headache, chills, fatigue, and loss of appetite. Recommended patient go to physician, patient refuses.									Y	11/17/2008	11/17/2008	0	None	PUB	PVT	METOPROLOL, 25mg; SINUSTATIN, 20mg	None	No allergies; COPD			1						1	Anorexia; Chills; Fatigue; Headache	FLU3~CSL LIMITED~01349111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0332825	11/19/2008	AK	49.0	49		F	11/19/2008	Reported: Half-dollar raised, felt like areas of erythema at both injection sites.  Extremely sore arms, unable to touch - entire arm sore.  Sick for 1 week after injection - low grade fever.									Y	10/15/2008				PVT	PVT		3 weeks post chemotherapy	Breast cancer; NKDA			1						1	Injection site erythema; Injection site swelling; Malaise; Pain in extremity; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89620~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0803U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332826	11/19/2008	MA	23.0	23		F	11/14/2008	Began to note shortness of breath and chest tightness, some dizziness.  No treatment sought.  Rested.  Some nausea, lack of appetite.  Symptoms gradually resolved today.									Y	11/13/2008	11/13/2008	0		UNK	UNK	None	None				1						1	Anorexia; Chest discomfort; Dizziness; Dyspnoea; Nausea	FLU3~SANOFI PASTEUR~U2795CA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332830	11/19/2008	CA	61.0	61		M	11/18/2008	Received flu vaccine for 1st time ever on 10/18/08 at 10am. By afternoon had runny nose, eyes watering, difficulty swallowing, aches and lip swelling. Seen in our ER at 17:38 for allergic prescription. Given BENADRYL, SOLU MEDROL and PEPCID and discharged. Better by 10/19/08.				Y					Y	10/18/2008	10/18/2008	0	None	PVT	PVT	current med at home VASOTEC	None	Numerous allergies, but not to flu vaccine. 1st time.			1						1	Dysphagia; Lacrimation increased; Lip swelling; Pain; Rhinorrhoea	FLU3~CSL LIMITED~01049111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0332831	11/19/2008	CO	45.0	45		M	11/19/2008	The patient felt faint and reported almost passing out. EMS was called and evaluated the patient. EMS after monitoring the patient and consulting with an ER physician allowed the patient to go home.									Y	11/19/2008	11/19/2008	0		OTH	PVT						1						1	Dizziness; Presyncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332832	11/19/2008	MT	65.0	65		F	11/17/2008	Intolerable pain (R) arm since 9PM of day of vaccine. Unable to move arm for 3-4days. Physical Therapy stated 8 days after injection. Pain continues today.				Y					U	11/05/2008	11/05/2008	0		PVT	UNK		None	None			1						1	Injected limb mobility decreased; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89124~5~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0978X~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332833	11/19/2008	TN	30.0	30		F	11/11/2008	Fever up to 103 deg F started about 48 hrs after shot given. (Flu shot). Swollen and achy neck body aches and chills. Lasted 3 days. Fever 103 deg. for on whole day. Then 101 deg for 2 days.									Y	10/12/2008	10/14/2008	2		PUB	UNK						1						1	Chills; Local swelling; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332834	11/19/2008	IN	28.0			F		Low grade fever, soreness in arms and legs.									Y					PUB	UNK		None				1						1	Limb discomfort; Pain in extremity; Pyrexia	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332835	11/19/2008	NE	51.0	51		F	11/19/2008	Runny nose, burning ears, reddened eyes, mattery eyes, throbbing lips, hives, angioedema.				Y					Y	11/18/2008	11/18/2008	0	None	PUB	PVT	Tylenol cold & flu multi symptom - OTC	None	None			1						1	Angioedema; Ear discomfort; Eye discharge; Ocular hyperaemia; Paraesthesia oral; Rhinorrhoea; Urticaria	FLU3~SANOFI PASTEUR~5659~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332864	11/20/2008	MD	83.0	83		F	11/02/2008	Severe pain and limitation in movement in upper right arm and shoulder. Pain has slowly decreased over a period of 2 weeks and range of motion is improving. Patient sought care at a hospital and was given pain medication and recommended for physical therapy.  10/24/08 ER record dated 10/31/08 received with DX: Calcific Tendonitis. Pt presnted with 9 day hx of shoulder pain since receiving flu shot.  PE (+) for tenderness, limited ROM, and weak arm abduction past 90'.				Y					U	10/22/2008	10/23/2008	1	X-Ray showed tendonitis and inflammation in right shoulder. There was also previous scar tissue.  Labs and Diagnostics:  Shoulder X-ray (+) for calcification along proxima R humerus. X-ray humerus (+) for likely calcific tendonitis of supraspinatus tendon.	OTH	PVT	LIPITOR; TRICOR; ZIAC	None	High cholesterol; Hypertension. PMH: HTN, hyperlipidemia			1						1	Inflammation; Injected limb mobility decreased; Musculoskeletal pain; Pain in extremity; Tendonitis; X-ray limb abnormal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA381AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0332865	11/20/2008	CO	1.3	1	.3	F	11/18/2008	Approx 24 hrs after immunization had prolonged (15 min) afebrile, generalized seizure required meds, intabatin, ICU admission. 12/8/08-records received for DOS 11/13/08-presented to ED with C/O multiple seizures. Tonice-clonic seizure and multipe seizure per EMS. Unarousable. Intubated. DX: Status epilepticus. UTI. transferred.  1/23/09-records received for DOS 11/13-11/14/08-DC DX:New onset afebrile seizure. Post-ictal and intubated due to deteriorating mental status and poor airway protection. Agitated, vomited. Subsequently extubated. Sleepier day of vaccination.				Y	Y	1			Y	11/12/2008	11/13/2008	1	Nrl CBC, metabolic, CSF blood, CSF cultures negative urine culture positive 30k Enterococous     12/8/08-records received- Lumbar puncture, mono  elevated 50, protein decreased 14. CT no mass. Labs significant for UTI.WBC 15.8. Urine protein 10-20, urine culture enterococus. Trace leukocyte esterase.  EEG normal. 1/23/09-records received- EEG normal.	PVT	PVT	None	None	Breath holding spells 1/23/09-records received-Hit head 2 weeks prior and a breath holding spell times 4.			1						1	CSF culture negative; Convulsion; Culture urine positive; Endotracheal intubation; Full blood count normal; Metabolic function test normal	FLU3~SANOFI PASTEUR~UT2785CA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1291X~1~UN~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Hospitalisation	Influenza
0332874	11/20/2008	OR	45.0	45		M	11/16/2008	Syncope, resulting in fall, blow to head with contusion: blow to ribs with contusion. ER visit.				Y					Y	10/14/2008	10/15/2008	1	Vasovagal Syncope	OTH	PVT	None	No	No			1						1	Contusion; Fall; Head injury; Skeletal injury; Syncope; Syncope vasovagal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA155AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0332875	11/20/2008	OR	7.0	7		F	11/13/2008	1005-Flu vaccine given. 1330-hives noted 1400-Benadryl given Benadryl repeated at 2000 and 0800, 1400, and 2000 on 10/29/2008									Y	10/28/2008	10/28/2008	0		OTH	PUB		NONE	Allergies: Cefzil		0R200844	1						1	Urticaria	FLU3~SANOFI PASTEUR~U2808AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332876	11/20/2008	OR	10.0	10		F	11/13/2008	1115-FLUZONE given; 1130 child developed hives and fussiness;1140-epinephrine given, MD notified; 1152-prednisolone 10 mg given, continued twice daily for 3days.									Y	10/28/2008	10/28/2008	0	10/29/08-child tested for allergies- tested (+) for egg allergy	OTH	PUB		None	allergies Benadryl;Valpruicacid; Varricella Vaccine	Hives~Varicella (no brand name)~2~9.00~Patient	0R200845	1						1	Allergy test positive; Allergy to vaccine; Drug hypersensitivity; Food allergy; Irritability; Urticaria	FLU3~SANOFI PASTEUR~U2808AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332877	11/20/2008	IL	76.0	76		M	11/17/2008	Pt's wife mentioned that her husband was hospitalized 1 month after receiving flu shot and that the neurologist thought that it might be Guillain-Barre Syndrome and that it may be from the flu shot. We have not spoken to the doctor. Wife has come in a few times afterwards but has not mentioned anything else. 1/29/2010 Patient had found out later he had had a stroke in his spinal cord. They ruled out the flu shot as being the course of paralysis. He has since passed away due to complications from sepsis.  3/9/09 Received hospital medical records of 11/13/2008-11/25/2008 FINAL DX: No d/c summary available.  Recent onset paraplegia; spinal vascular malformation, unlikely GBS. Records reveal patient experienced s/s as noted above including progressive parapesis, sensory loss & bowel/bladder dysfuntion, paraplegia T8 & had been transferred from outlying hospital.  Admitted to ICU & continued on steroids.  Neuro, Neurosurg, Medicine, Heme, Nephro & Uro consults done.  12/11/08 Reviewed hospital medical records of 10/29-11/7/08. FINAL DX: Guillain Barre syndrome; paraplegia; atrial fib; ileus; urinary retention. Records reveal patient experienced Gi symptoms & URI approx 1 wk prior to admit.  On admit had LE numbness & weakness, areflexia. Neuro & cardio consults done. Tx w/plasmapheresis.  Transferred to inpatient rehab.  Worsened & returned to acute care 11/10 for further treatment & evaluation.  1/23/09 Reviewed hospital medical records of 11/9-11/12/2008. FINAL DX: paraplegia perhaps secondary to some spinal cord hemorrhage Records reveal patient experienced initial leg weakness that rapidly progressed to complete paralysis which had been dx as GBS.  Pt had been transferred to rehab where neurologists felt presentation atypical for GBS & repeated MRI which revealed possible bony metatases & spinal cord abnormality.  Readmitted to acute care where exam revealed complete paralyisis & anesthesis from waist down w/loss of bowel & bladder control.  Transferred to higher level of care.				Y	Y	27			U	09/22/2008	10/29/2008	37	Unknown  LABS: CT & MRI abnormal.  EMG abnormal.  CSF protein elevated. H/H 10.4/30.9(L).  BUN 35(H)Thoracic spine MRI abnormal revealing multiple lesions, multiple liver nodules & right renal mass.  MRI brain abnormal.  Spinal angiogram WNL.  EKG & CXR WNL.  Echocardiogram abnormal.  PSA 15.3(H).  Ca19-9 48.8(H)  CSF: protein 91(H), glucose 51, WBC 4, RBC 75.  CRP 6.4(H). Bone scan c/w likely bony hemangiomas.  CT of chest/abdomen c/w liver hemangiomas.	OTH	OTH	Unknown	None	None known  PMH: atrial fib on anticoagulation therapy.  BPH. GERD.			1						1	Asthenia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0332882	11/20/2008	MA	13.0	13		F	11/18/2008	13 year old received vaccines above. Initially seemed well, patient then stood up while stumbling. Vaccinated. Nursing stopped the report hearing that patient on the ground. Patient hit head. Contusion.				Y					Y	11/18/2008	11/18/2008	0	Pulse, ox 98%; Blood sugar 93; Cspine; immobility; transported to ER for further evaluation	PVT	UNK						1						1	Blood glucose normal; Contusion; Gait disturbance; Head injury; Oxygen saturation normal	FLU3~SANOFI PASTEUR~V2840AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~V2727AA~UNK~UN~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~1192X~2~UN~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0332884	11/20/2008	NC	20.0	20		F	11/19/2008	Received flu vaccine in left arm and TDAP in right arm. Developed increasing Rt upper arm, Rt upper back and neck pain over subsequent couple days. Developed fever to 102 degrees F, diarrhea and nausea, dizziness. Eventually had trouble abducting rt arm and moving neck. Fever, diarrhea, nausea, and dizziness resolved.									U	11/07/2008	11/07/2008	0		OTH	PVT						1						1	Back pain; Diarrhoea; Dizziness; Injected limb mobility decreased; Injection site pain; Nausea; Neck pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88132P~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C2768BA~UNK~UN~RA~TDAP (ADACEL)~1	USA		Influenza
0332895	11/20/2008	CO	54.0	54		F	11/20/2008	Trouble breathing, feelings of throat closing. Occurred hours after vaccine given. Treatment Benadryl 100mg IM and Decadron 10mg IM.				Y					Y	11/18/2008	11/18/2008	0	O2 Sats 94-96%	PVT	OTH		Sinus infection	Dm type II; Depression; GERD; Seizure DO			1						1	Dyspnoea; Oxygen saturation normal; Throat tightness	FLU3~SANOFI PASTEUR~U2748AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332896	11/20/2008		3.0	3		F	11/20/2008	Gave pediatric does of Hepatitis A to this patient after shot gave was when the expiration was noted to be 6 days old. I checked the expiration date prior to shot it did not register as being 6 days expired before I gave the shot. Child is fine, no reaction from shot at all.									Y	11/05/2008				OTH	PVT	NONE	NONE	NONE			1						1	Expired drug administered	FLU3~SANOFI PASTEUR~UT27881A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~AHAVB097BB~1~IM~RA~HEP A (VAQTA)~1	USA		Influenza
0332902	11/20/2008	CT	24.0	24		M	11/20/2008	Pt received flu vaccination at approx. 0930.  Between 1130-1230 pt reports passing out in front of computer.  No witnesses around.  Reports a headache pain of 8/10, pressure at top and sides of head.  Pt also reports fatigue and upper body aches.  Pt took 650mg Tylenol at 1440.  Pt recently returned from R&R about 1.5 weeks ago, still not on regular sleep cycle, reports working out, decreased appetite, and decreased water intake.  Reports no caffeine intake except for an energy drink prior to working out, and taking supplements/vitamins.									Y	11/20/2008	11/20/2008	0	VSS WNL at 130/83, hr 72, rr 19, t 98.3 F	MIL	MIL	supplements/vitamins	none	n/a			1						1	Decreased appetite; Fatigue; Headache; Hypophagia; Loss of consciousness; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA193AA~5~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332903	11/20/2008	SD	32.0	32		F	11/20/2008	Fluzone administered on 11/07/08.  On 11/14, patient reported that her arm was achy and she has difficulty in lifting the affected arm, especially early in the AM.  No tenderness upon palpation, no induration or swelling at site.  Writer recommended hot packing, acet/ibuprofen and report back to our office in several days.  On 11/19, patient reported still having weakness.  She will consult a physician.									U	11/07/2008	11/08/2008	1		UNK	UNK						1						1	Asthenia; Injected limb mobility decreased; Limb discomfort	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332904	11/20/2008	IL	33.0	33		F	11/20/2008	Receieved vaccine in left deltoid.  Within 20 minutes, 2x2 red rash around injection site.  Pt. states burns/itches.  Rated 5 on pain scale.  B/P 130/70, ice applied, arm elevated.  Called physician/physician ordered 2 benadryl PO stat & to apply ice & elevate.  They stated it was a local reaction.  Pt. states my whole body feels hot.  administered 50 mg (2 capsules) Diphenhydramine Hydrochloride PO.  Pt states Pain is better now.									Y	10/20/2008	10/20/2008	0		UNK	PVT	Unknown	Unknown	Unknown			1						1	Feeling hot; Injection site erythema; Injection site irritation; Injection site pruritus; Injection site rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA185AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0332905	11/20/2008	NY	40.0	40		M	11/20/2008	swollen uvula with a clear film over it Occurred am after vaccine administered.  Slight sore throat on morning of vaccination.  No fever at all during that day or the day after.  this has happened before. Pt feeling better 11/20/08 and feels sx not related to flu vaccine.									Y	11/17/2008	11/18/2008	1		PUB	UNK		Had mentioned having a slight sore throat that am.  no fever or other sx.				1						1	Enlarged uvula	FLU3~SANOFI PASTEUR~U2742AA~1~ID~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332907	11/20/2008	IL	84.0	84		F	11/20/2008	Swelling, redness, below arm approximately 3 inches where shot was given rt. arm  Went to Md. Thursday stated infected-physician gave antibiotics.  Pain, body aches and arm pain. Went to MD receieved antibiotic Levaquin 500 mg. q day.  Started 10/16/08. Put cool compress, rest sore arm, Tylenol if needed.  Physician ordered IV anibiotics.  Physician concerned it may be Staph infection, referred to Dr.				Y					U	10/15/2008	10/15/2008	0		UNK	UNK	UNKNOWN	UNKNOWN	UNKNOWN			1						1	Erythema; Oedema peripheral; Pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89966~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1161X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332908	11/20/2008	CA	63.0	63		M	11/20/2008	Rash accompanied by itching.  First appeared in groin area on 10/24/08.  Applied topical ointment.  Began to subside after 4-5 days.  Resurfaced in navel and both ankles on 10/30/08.  Applied topical ointment.  Began to subside after 4-5 days.  Resurfaced on both forearms, upper arms, underarms, scrotum and anus on 11/6/08.  Visited family physician and dermatologist on 11/7/08 and 11/10/08 respectively.  Unable to readily determine cause.  Continued applying topical ointment.  Rash showed little signs of improvement and resurfaced on left ankle.  Returned to dermatologist on 11/14/08.  Took biopsy from left arm (results pending).  Administered Prednisone 20 mg. for 8 days.  Treatment not yet completed.				Y					Y	10/14/2008	10/24/2008	10	Skin biopsy results pending.	PUB	PVT	Zocor, Effexor, Nexium, Lorazipam, Nasonex	None	Acid Reflux, Mild Depression, Cholesterol Management, Sleep Apnea			1						1	Biopsy skin; Pruritus; Rash	FLUX~SANOFI PASTEUR~42803AA~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0332910	11/20/2008	NC	51.0	51		F	11/20/2008	Pt. reported she started experiencing symptoms approximately four hours after receiving the vaccination. Symptoms included wheezing, eyes - burning, itching, redness and swelling, swelling of the throat, fever, and headache. Stated she took Advil and went to bed. Called the Health Department and made the report the next day.									N	11/18/2008	11/18/2008	0	none	PUB	PVT		none	none			1						1	Eye irritation; Eye pruritus; Eye swelling; Headache; Ocular hyperaemia; Pharyngeal oedema; Pyrexia; Wheezing	FLU3~SANOFI PASTEUR~U2768AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332911	11/20/2008	IL	84.0	84		F	11/20/2008	Sore, slightly swollen right arm.  Approximately 3-4 hours later.  Put cool compresses in evening then warm this a.m.  Coordinator advised to continue cool compresses, Tylenol if able and needed.  If feel the need you can call your physician.  Patient stated she will be calling her physician or going to Emergency room is problem persists..									U	10/16/2008	10/16/2008	0		UNK	PUB	Unknown	Unknown	Unknown			1						1	Oedema peripheral; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89966~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0555U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332912	11/20/2008	CO	11.0	11		M	11/20/2008	4 inch red edematous area over left tricept. Warm to touch and no pruritus. First appeared as small welt 24hrs after administration. Increased in diameter at 36hrs. Benadryl given. Site continues to appear warm, red, and slightly edematous after 48hrs. Client remains afebrile.									Y	11/18/2008	11/19/2008	1		PUB	PUB						1						1	Erythema; Skin warm	FLU3~SANOFI PASTEUR~U2828AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~AHAVB246AA~1~IM~RA~HEP A (VAQTA)~1|MNQ~SANOFI PASTEUR~U2661AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B027AA~1~IM~LA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~0529X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0332913	11/20/2008	IL	61.0	61		F	11/20/2008	Red, sore, swollen, temperature of 100, don't feel sick just arm hurts.  Patient took Tylenol. Coordinator recommended applying a ice-pack, take Tylenol, no lifting per that arm, elevate arm at rest, phone MD if problems persist. Patient went to physician....antibiotics were ordered ...at this time everything resolved....				Y					Y	09/23/2008	09/24/2008	1	Unknown	UNK	UNK	Unknown	Unknown	Unknown			1						1	Body temperature increased; Erythema; Swelling; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA185AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0989U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332915	11/20/2008	FL		46		F	11/20/2008	after administration pt felt light headed. sat pt down, pt requested to lay down.  had pt sit on floor and emt was called. pt conplained of stomach pain and a little nausea. emt responded within 15 minutes.									U	11/20/2008	11/20/2008	0		UNK	PVT						1						1	Abdominal pain upper; Dizziness; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflla157aa~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332917	11/20/2008	OH	58.0	58		F	11/20/2008	Patient had pain in her arm. It radiated up to her neck and made it painful to put on a sweater, drive her car, or lie down. Sometimes she got headaches. Tylenol didn't seem to help.									U	11/02/2008	11/02/2008	0		UNK	UNK						1						1	Headache; Neck pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2751AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332918	11/20/2008	LA	1.25	1	.3	F	11/20/2008	rash & irritability									U	11/19/2008	11/19/2008	0	none	PVT	PVT	none	none	none			1						1	Irritability; Rash	DTAPH~SANOFI PASTEUR~u16726c~4~IM~LL~DTAP + HIB (TRIHIBIT)~1|FLU3~SANOFI PASTEUR~ut2783da~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~c80901~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0332919	11/20/2008	MA	52.0	52		F	11/20/2008	diffused light erthema over 50% of lateral upper arm ,tender to touch ,limited ROM at shoulder.				Y					Y	11/17/2008	11/18/2008	1		PVT	PVT		N/A	asthma, HTN, hypothyroidism,hyperlipidemia			1						1	Erythema; Injected limb mobility decreased; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA388BA~6~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1679U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332921	11/20/2008	IN	60.0	60		F	11/20/2008	felt chest heaviness, funny sensation in throat almost immediately after injection. checked blood pressure, monitored for 30 minutes with resolution of symptoms.									Y	11/20/2008	11/20/2008	0		UNK	UNK	ativan	none	allergy to dust, molds, trees, grass, dogs, sulfa, tetracycline			1						1	Chest discomfort; House dust allergy; Immediate post-injection reaction; Throat irritation	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflla186aa~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332922	11/20/2008	ME	76.0	76		M	11/20/2008	Fever and delirium for several hours starting 3-4 hrs post vaccines. Resolved spontaneously. 11/24/08 D/C summ received for DOS 11/12-15/2008 with D/C DX:  Pituitary Cystic Adneoma.  Episodic fever-resolved.  Incontinence-resolved.  Altered mental status-resolved. Hyperlipidemia.  HTN. Acute kidney failure-resolving.  Anemia. Pt presented to ER with fever, delium, confusion and urinary incontinence which began several hours after receiving flu and pneumonia vaccines. Pt admitted an by the following morning sx had resoved with abx.  The evaluation revealed other medical problems: Acute renal failure, blood pressure elevation, anemia and a Pituitary adenoma which will be followed as an outpatient.				Y	Y	3			Y	11/12/2008	11/12/2008	0	MRI: Brain, CT: Head, Chest X-Ray, Several lab tests including blood cultures. Labs and Diagnostics: Creatinine 1.6. UA (+) for RBCs. Hgb 10.8. Hct 31.5. Brain MRI and CT (+) for cystic mass arising from Pituitary. CXR WNL.	UNK	UNK	B12, ASA, Tamsulosin, Lisinopril, Glucosamine, Nasonex, Flomax, Zocor, Folic Acid	None	Renal Insufficiency, HTN, Pituitary D/O, Pernicious Anemia, Macular Degeneration, Hyperlipidemia, Arthritis, Hyponatremia, Folate deficiency, Nocturia, Edema. Allergies: Sulfa PMH: HTN. Hyperlipidemia			1						1	Blood culture; Delirium; Laboratory test; Pyrexia	FLU3~SANOFI PASTEUR~U2762AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1541U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0332923	11/20/2008	IN	45.0	45		F	11/20/2008	3 weeks post vaccination patient had red indented area size of quarter at site of injection.  Tender to touch and turned bright red after showering. Was not improving and was going to see physician.				Y					U	10/20/2008	10/25/2008	5	none	PUB	PUB	UNKNOWN	NONE	NONE KNOWN			1						1	Injection site atrophy; Injection site erythema; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA380DA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0332926	11/20/2008	IL	60.0	60		F	11/20/2008	This nurse realized she gave (2) flu shots to (1) person vs giving a flu and pneumonia as intended.  She indicated there were (2) people in line and that she drew up (2) syringes with flu vaccine.  While patient was filling out consent form the client decided to get a pneumonia shot so nurse drew up a pneumonia shot and laid it by glove to know that is what it was.  She then gave flu shot and when she was supposed to grab the pneumonia she accidently grabbed the other syringe with the flu vaccine and administered.  Nurse stated that she did not notice this error until serving the next client.  Nurse noticed that the syringe was still sitting by the glove and she knew that is where she sat the pneumonia vaccine filled syringe. Flu coordinator notified patient of possible side effects.  Flu coordinator verified possible side effects with flu manufacturer.  Flu coordinator notified patient physician...no orders given  Right arm sore.  Patient complained of chills, sick to stomach, lack of hunger, vomited, dizziness.									Y	10/01/2008	10/01/2008	0		UNK	UNK	Unknown	Unknown	Unknown			1						1	Chills; Decreased appetite; Dizziness; Malaise; Tenderness; Vomiting; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA185AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332927	11/20/2008	IL	70.0	70		F	11/20/2008	On 10/27/08 a 70 y/o female was vaccinated with influenza and pneumococcal vaccine at a senior citizen community walk-in vaccination clinic.  The vaccines were provided by the agency and administered by the nursing staff. Pneumo and Flu vaccine were administered at the same time in different sites.  Patient notified the Health Department Vaccine Safety Officer to report the following event:  Aprox. 24 hours post vaccination the pt. c/o Lt. deltoid redness, extending to under armpit, with accompanying pain lasting 7 days.  Pneumo  vaccine documented was administered Lt. deltoid.   Pt saw Pvt. MD on 10/29/08 was evaluated no Tx or therapies given.				Y					Y	10/27/2008	10/28/2008	1		UNK	UNK	Methotrexate, Arava, Diovan, Welchol, Premarin	No	Arthritis, HTN, h/o cancer in remission			1						1	Erythema; Pain	FLU3~SANOFI PASTEUR~U2770AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1132U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332928	11/20/2008	FL	74.0	74		F	11/20/2008	10/14/08: patient received Fluvirin in left deltoid 10/30/08: patient went to see physician for complaint of pain in left arm. Pain started 2 days after receiving injection. Physician reported no obvious lesion, no erythema or warm of shoulder; and patient has full range of motion. Physician concluded probably reaction to flu injection and prescribed Celebrex. 11/04/08: Patient came in to store and reported her complaint. Patient stated to me that she still have pain in left shoulder that seems to move to different areas of her left arm such as to shoulder and arm pit, but no where else. Patient said that pain is not getting worse but decreasing at a very slow rate. Patient also stated that she has hematoma. However, her physician's report did not indicate hematoma. Upon examining of her arm, I did see any bruising, skin discoloration, or any other physical signs that would indicate hematoma or pain. 11/18/08: I called patient so check on her current condition. Patient stated that her pain has decreased, but it is still there and has not completely returned to pre-vaccination state.									N	10/14/2008	10/16/2008	2		UNK	UNK	unknown	none	none			1						1	Haematoma; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332929	11/20/2008	SC	31.0	32		F	11/20/2008	NUMBNESS IN HANDS AND ARMS, REDNESS AT SITE OF INJECTION									Y	11/06/2008	11/06/2008	0	WENT TO NURSES STATION AT WORK TO HAVE CHECKED OUT	UNK	PVT	PRENATAL VITAMINS	NONE	PREGNANCY 27 WEEKS			1						1	Hypoaesthesia; Injection site erythema	FLU3~SANOFI PASTEUR~U2839AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332933	11/20/2008	PA	65.0	65		F	11/20/2008	Received vaccine on 11/4.  On 11/5, developed fever of less than 102 degrees, which lasted for two days, along with body aches.  also developed cellulitis at injection site on left upper thigh.  Site became swollen, red, very sore and made mucsle ache and leg weak when attempting to stand.  Fever resolved in two days, but cellulitis covered a patch of skin 3 by 7 across top of thigh, then going down side of outer thigh another 3 by 7 down.  Area was very tender to touch, swollen, itchy, and sore.  The redness and swelling and itch lasted until 11/10, and soreness until 11/14.  Redness gradually faded.  I did return to my doctor for consultation regarding the cellulitis to see if medical intervention was necessary.  He decided to hold off on antibiotics to see if condition resolved on its own.  It is now okay, with only slight soreness, but no redness or itch as of 11/20									Y	11/04/2008	11/05/2008	1	None	PVT	PVT	Valtrex, Acyclovir, Guaifenisen, HCTZ, Mutlivitamins, Calcium, Vit D, Singulair, Allergy serum, Astelin nasal spray, Fluticasone Nasal spray,	Facial neuralgia, sinus congestion	Year round allergies to dust, mold, grasses, trees, cat; breast cancer 12 years ago			1						1	Injection site cellulitis; Injection site erythema; Injection site pain; Injection site pruritus; Injection site swelling; Muscular weakness; Myalgia; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332934	11/20/2008	WA	62.0	62		F	11/20/2008	Debilitating joint pain, joint aches, that began within one hour and a half after injection was given. Pain resulted in loss of sleep for several days. Self treatment with Tylenol accomplished no relief. Visited Urgent Care on 11/16 and was seen by Dr. Blood tests were done. The doctor prescribed 600 mg ibuprofen 3 x daily which resulted in some relief. Advised to follow up in two days with primary care doctor who diagnosed arthralgia, and unspecified anemia. Pain still exists at this date. Blood tests to follow to determine further treatment.				Y					U	11/13/2008	11/13/2008	0	Initial blood tests showed elevated levels of reactive protein for inflammation, sediment tests show elevated levels as well, plus related anemia possibly due to the inflammation.	UNK	UNK	none	None	None			1						1	Anaemia; Arthralgia; Blood test abnormal; C-reactive protein increased; Insomnia; Red blood cell sedimentation rate increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~888907~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0332935	11/20/2008	VA	29.0	33		F	11/20/2008	PAIN AND WEAKNESS AT INJECTION SITE SINCE VACCINE ADMINISTRATION ON 10/14/2008									U	10/14/2008	10/14/2008	0		PVT	PVT		None Indicated	None Indicated			1						1	Injection site pain; Muscular weakness; Arthralgia; Joint swelling; Musculoskeletal pain; Pain in extremity	FLU3~CSL LIMITED~02649111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|FLU3~SANOFI PASTEUR~u2795BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0332937	11/20/2008	IN	25.0	25		F	11/20/2008	Irregular epileptic seizure in patient with previous history of medication-controlled epilepsy.									Y	11/14/2008	11/14/2008	0		UNK	UNK	Keppra, Lamictal, Zonegran, Balziva, citalopram	None	Epilepsy			1						1	Condition aggravated; Epilepsy	FLU3~SANOFI PASTEUR~U2757AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332940	11/20/2008	TX	42.0	42		F	11/20/2008	After 3 hours  of get the vaccination,  I felt  my throat like stuck and I felt  pain in my throat too.The next day  I felt  headache and felt   heat in some parts of my body.									Y	11/04/2008	11/04/2008	0		UNK	PVT	Lorazepan,  Escitalopran, Lipitor					1						1	Feeling hot; Headache; Oropharyngeal pain	FLUX~UNKNOWN MANUFACTURER~000000~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332941	11/20/2008	GA	60.0	60		F	11/20/2008	Within 30-45 minutes of receiving vaccine I experienced mild dizziness which lasted continually for about 4 hours. I have had numerous flu vaccines in years past and never experienced any reaction.									Y	11/04/2008	11/04/2008	0		PUB	PUB	Metoprolol 25mg; Zocor 20mg; Fluoxetine 10mg; Melatonin	none	Post-polio sequalea; high blood pressure; mild depression			1						1	Dizziness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332945	11/20/2008	IL	49.0	49		M	11/20/2008	Nurse Administered the FLUMIST as directed to each nostril. Immediately the patient became pale he complained of nausea, light headed and he began to sweat. Nurse took his blood pressure and it was 80/60. We then made him comfortable and watched him for about 10 minutes and then called 911. An ambulance arrived and took him to the hospital.				Y					Y	11/20/2008	11/20/2008	0	Blood pressure 1. 80/60 2. 85/60 3. 100/80	OTH	PVT		NONE AWARE	Has had vaso-vagal reaction before w/eye exam			1						1	Dizziness; Hyperhidrosis; Immediate post-injection reaction; Nausea; Pallor	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0332947	11/20/2008	CA	39.0	39		F	11/19/2008	38 year old received the FLUARIX on the rt. deltoid area IM on 11/4/08. 3 days later she returned to the health department c/o Rt. deltoid area pain (8 on 1-10 scale), local tenderness, mild swelling, numbness throat radiated distally and ROM, and paroxysmal tachycardia. Pt was advised to cont. taking Ibuprofen, warm compresses, and see her primary care provider for further evaluation. Pt. returned on 11-10-08 c/o minor changes and improvement. Referred to PCP.				Y					N	11/20/2008	11/20/2008	0	None done. uninsured patient (seasonal temporary field worker)	PUB	UNK	Patient has been taking Ibuprofen and Vit B complex at onset of symptoms	Non contributory	Past medical history; unremarkable- social: field worker			1						1	Pain in extremity; Pharyngeal hypoaesthesia; Swelling; Tachycardia paroxysmal; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA1T8AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0332948	11/20/2008	CA	18.0	18		F	11/20/2008	Received Flu vaccine at Wellness fair around 1330. Noticed lip tingling and swelling at around 8PM. Took Benadryl 50mg tablet to relieve symptoms.				Y					N	11/19/2008	11/19/2008	0		OTH	PVT	None	None	Lanolin			1						1	Paraesthesia oral; Swelling	FLU3~SANOFI PASTEUR~U2751AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332949	11/20/2008	WA	35.0	35		F	11/20/2008	FLUVIRIN was administered to a pregnant women. On 11/08/08 this patient should have received FLUARIX (thimerosal free) vaccine Per follow-up: Box 11 - There is no adverse event. Customer is fine.									U	11/08/2008				OTH	UNK						1						1	Drug exposure during pregnancy	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89620~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0332952	11/20/2008	GA	69.0	69		F	11/20/2008	Area to right upper arm anterior deltoid of approximately 20 cm in length going distally from deltoid towards anticubital joint but not involving joint, and 16cm in width at widest point lateral to medial with irregular demarcated borders pink/erythematous in color, with warmth to touch, superficial edema.				Y					U	11/19/2008	11/20/2008	1		OTH	OTH						1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~SANOFI PASTEUR~U2831AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~13826~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332956	11/20/2008	FL	77.0	77		F	10/31/2008	Cellulitis like in (L) upper arm.									Y	10/29/2008	10/30/2008	1		UNK	UNK						1						1	Cellulitis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA165AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0332958	11/20/2008	VT	37.0	37		F	11/20/2008	! day after receiving vaccine, had symptoms of achiness, flu-like symptoms, temperature 100.1(1 hour after TYLENOL) dry hackey cough. Put on antibiotics, ZITHROMAX 250mg by mouth times 7 days( 5days after vaccine administered. Patients brother had similar reaction).				Y					Y	11/11/2008	11/12/2008	1		PVT	PVT				Flu symptoms~Influenza (Seasonal) (no brand name)~1~40.00~In Sibling		1						1	Body temperature increased; Cough; Influenza like illness; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA386AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0334996	11/20/2008	CA	2.0	2	.8	M	10/24/2008	A serious report of dehydration and acute gastroenteritis has been received from a study investigator concerning a 33-month-old male (PID 27391993) participating in a post-marketing study from FluMist MI MA162 A Post Marketing Evaluation of the Safety of FluMist in Children 24-59 Months of Age in a Managed Care Setting.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the study indicated population of 2 years to 59 months of age for FluMist.  Medical history included no known allergies, hospitalization in August 2006 for acute gastroenteritis and dehydration and chronic diarrhea in December 2006.  Concomitant medications included Paaracetamol.  On 05 Feb-2008, the subject received FluMist.  He also received the Hepatitis A vaccine on the same day.  On 10-Feb-2008, the patient presented to the emergency room (ER) for vomiting, diarrhea, and fever.  Vomiting started at 4:00am on 17-FEB-2008 and continued about three or four times an hour until 11:00pm.  The patient also had diarrhea several times an hour during the first eight hours of the illness.  On 18-Feb-2008, the patient developed fever to 104 at home and continued with vomiting and diarrhea several times with no blood or muccus.  Given the fevers and signs of dehydration he had three urines in 24 hours, dark colored, dried lips, less energy, and sleeping all day, his patients brought him to the ER.  There was no cough or runny nose, no headache or ear pain.  The patient drank about 20 ounces of fluids on 18-Feb-2008 but threw up most of it.  In the ER, he was given normal saline. 20ml/kg intravenous (IV) bolus and ondansetron.  He had poor oral intake, several episodes of diarrhea and emesis and was therefore admitted on 19-Feb-2008 for further IV hydration and observation.  Diagnoses were dehydration and acute gastroenteritis.  The patient had a normal white blood cell count 11.6 with some left shift consistent with viral process and mild hyponatremia (sodium 133) with metabolic acidosis consistent with dehydration. Blood Chloride was 86, carbon dioxide 19 and anion gap 18.  In the hospital, the patient was treated with IV fluids at 1.25x maintenance rate initially, weaned to 1x maintenance.  He was tolerating oral fluids well with no vomiting and the diarrhea slowed down significantly.  The patient had diaper rash for which his parents had been applying zinc oxide (DESITIN).  He was having good urine output and only one stool overnight.  The exam on the day of discharge ws unremarkable.  Stool test for cryptosporidium, Cloxtridiam difficile, and stool cultures were all negative.  The patient recovered from the events on 20-Feb-2008.  The investigator asscesed causality of the events of dehydration and acute gastroenteritis to FluMist as remote and provided the alternative etiology of natural and the severity as mild.  Additional information received on 24-Oct-2008 and incorporated into the narrative included medical history, concomitant medications, details about the hospitalization and event outcome.					Y				Y	02/05/2008	02/17/2008	12	Anion gap               02/19/08              18                  5-16 Carbon dioxide       02/19/08              19                 22-30 Chloride                 02/19/08               98                 98-107 Sodium                  02/19/08               133               137-145 Stool culture          02/19/08               negative        White blood cell    02/19/08                11.6              5.9-15.5 count	OTH	OTH	TYLENOL	Pain in hip	Stool negative for cryptospcridium and Clostridium difficile.  Fast disease:  Gastroenteritis, Dehydration, Chronic diarrhea.		MEDI0007259	1						1	Anion gap increased; Asthenia; Blood sodium normal; Carbon dioxide decreased; Chromaturia; Culture stool negative; Dehydration; Diarrhoea; Gastroenteritis; Lip dry; Pyrexia; Somnolence; Vomiting; White blood cell count normal	FLUN3~MEDIMMUNE VACCINES, INC.~IN500500P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~HEP A (HAVRIX)~1	USA	Hospitalisation	Influenza
0334997	11/20/2008	CA	4.0	4		F	10/06/2008	A serious study report of tonsillitis and obstructive sleep apnea was received from a study investigator, concerning a four year-old female patient (patient 56398710) enrolled in post marketing study. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 year to 59 months of age for FLUMIST. Medical history includes tonsillitis and obstructive sleep apnea diagnosed on 14-Aug-2007. The patient also has a history of urticaria. Patient was not on any concomitant medication and has no known allergies. The subject is in daycare and gets frequent colds. The patient received FLUMIST on 12-Nov-2007 for influenza immunization. The patient was hospitalized on 26-Nov-2007 for tonsillitis and obstructive sleep apnea. Tonsillectomy and adenoidectomy were performed and were well tolerated. The patient recovered and was discharged on 27-Nov-2007. The events were considered mild. The patient reported pain a week after procedure and subsequently the pain medication was increased and was advised to increase fluid intake. The investigator assessed the events as not related to FLUMIST.					Y	1			Y	11/12/2007	11/25/2007	13		OTH	OTH	Concomitant drug(s) not reported.	Tonsillitis; Obstructive sleep apnea syndrome	Urticaria		MEDI0007260	1						1	Adenotonsillectomy; Condition aggravated; Pain; Sleep apnoea syndrome; Tonsillitis; Sleep apnoea syndrome; Tonsillitis	FLUN3~MEDIMMUNE VACCINES, INC.~500496P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Hospitalisation	Influenza
0334997	11/20/2008	CA	4.0	4		F	10/06/2008	A serious post-marketed study report of tonsillitis and obstructive sleep apnea has been received from a study investigator concerning a four-year old female subject, patient ID 56398610, participating in a post-marketing study. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this subject. The subject received FLUMIST on 12-Nov-2007. On 26-Nov-2007, the subject was hospitalized for tonsillitis and obstructive sleep apnea. The subject's length of hospital stay was one day. The outcome is unknown. The investigator assessed the events of tonsillitis and obstructive sleep apnea as not related to FLUMIST. The sponsor assessed the relationship of the events as not related to FLUMIST.					Y	1			Y	11/12/2007	11/14/2007	2		OTH	OTH	Concomitant Drug(s) Not Reported	syndrome	Urticaria; tonsilitis		MEDI0007273	1						2	Adenotonsillectomy; Condition aggravated; Pain; Sleep apnoea syndrome; Tonsillitis; Sleep apnoea syndrome; Tonsillitis	FLUN3~MEDIMMUNE VACCINES, INC.~500496P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Hospitalisation	Influenza
0334998	11/20/2008	CA	4.0	4		F	10/23/2008	A serious report of pneumonia has been received from a study investigator concerning post-marketing study for FLUMIST. This case is submitted in accordance with post-marketing commitment on accelerated reporting for newly indicated population of 2 to 59 months of age for FLUMIST. Medical history included no known allergies, asthma, and a positive purified protein derivate on 04-Dec-2007. Concomitant medication includes amoxicillin and albuterol. On 08-Jan-2008, the subject received FLUMIST. On the same day, the patient also received DTaP and MMR-VAR. Since 04-Dec-2007, the subject had two cases of cough, fever, and abnormal X-ray. She was diagnosed with community accuired pneumonia. Her father had recently been diagnosed with active TB so she was admitted to the hospital on 05-Feb-2008 to rule out active TB. Gastric aspirates x three were obtained for AFB smear and TB cultures. Chest CT scan was obtained to further evaluate the subject's pulmonary process. It showed no hilar LAD but two areas of infiltrated possibly consistent with resolving pneumonia. The county TB clinic indicated the contact case was pan-sensitive Mycobacterium tuberculosis but very high organism load/infectivity. Given the subject's risk and possibly abnormal pulmonary imaging, she was discharged on 07-Feb-2008 on quadruple drug therapy to be continued at least until the gastric aspirate cultures were final. On 08-Feb-2008, all three gastric aspirates were negative and the subject was doing well with no respiratory distress and was able to return to preschool. The pneumonia resolved on 11-Feb-2008. The investigator assessed the causality of the event of pneumonia to FLUMIST to be none and provided the alternative etiology of natural, viral. The severity of the event was moderate. Additional information received on 23-Oct_2008 and incorporated into narrative included concomitant therapy, medical history, and event outcome.					Y	2			Y	01/08/2008	02/05/2008	28	Chest CT scan, No hilar LAD but 2 areas of infiltrate possibly consistent with resolving pneumonia; Gastric aspirates x3 for AFB smear TB cultures-negative x3; Chest X-ray, NI, abnormal	OTH	OTH	Amoxicillin, Albuterol	Asthma	04-Dec-2007 PPD; positive. 05-Feb-2008 Gastric aspirates x3 obtained for AFB smear and TB cultures negative. 05-Feb-2008 chest CT scan showed no hilar LAD but 2 areas of infiltrate possibly consistent with resolving pneumonia.		MEDI0007261	1						1	Chest X-ray abnormal; Computerised tomogram abnormal; Culture negative; Laboratory test normal; Pneumonia	DTAP~UNKNOWN MANUFACTURER~~5~UN~UN~DTAP (NO BRAND NAME)~1|FLUN3~MEDIMMUNE VACCINES, INC.~506500P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMRV~UNKNOWN MANUFACTURER~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA + VARICELLA (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0334999	11/20/2008	CA	3.0	3		F	11/23/2008	A serious report of acute gastroenteritis and viral syndrome has been received from a study investigator concerning a 43 month old female (PID 07393517) participating in a post-marketing study for FLUMIST. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history included urticaria and no known allergies. There were no concomitant medications. On 21-Nov-2007, the subject received FLUMIST. The patient was seen in the emergency room for abdominal pain on 06-Dec-2007, which began on 05-Dec-2007 pain improved on 06-Dec-2007 but started again on 08-Dec-2007 and caused her to cry. On the day of presentation she also had fever on 104. She received an IV fluid bolus of 20ml/kg and IV morphine. Although differential diagnosis included possibility of appendicitis, this was felt to be unlikely. She was admitted for observation and dehydration on 08-Dec-2007. Abdominal chest x-rays and urinalysis were unremarkable. White blood cell count was 8.7. Diagnoses were acute gastroenteritis and viral syndrome. The patient was discharged on 09-Dec-2007. On 10-Dec-2007 the patient's parents stated she was feeling better this AM acting normal no fever no pain. The patience recovered on 10-Dec-2007. The investigator assessed the causality for the events  to FLUMIST as none and provided the alternative etiology of natural causes, viral. The severity of the events was mild. Additional information received on 23-Oct-2008 and incorporated into the narrative included medical history details about the hospitalization and event outcome.					Y	1			Y	11/21/2007	12/05/2007	14	Abdominal x-ray, 12/08/2007, unremarkable; Chest x-ray, 12/08/2007, unremarkable; Urinalysis, 12/08/2007, unremarkable; White blood cell count, 12/08/2007, 8.7	OTH	OTH	Concomitant drug(s) not used	Urticaria			MEDI0007262	1						1	Abdominal X-ray; Abdominal pain; Chest X-ray normal; Crying; Dehydration; Gastroenteritis; Pyrexia; Urine analysis normal; Viral infection; White blood cell count normal	FLUN3~MEDIMMUNE VACCINES, INC.~500496P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0335000	11/20/2008	CA	2.0	2	.6	F	10/06/2008	A serious clinical trial report of pneumonia and croup has been received from an investigator concerning a 32 month old female, subject number 28351523 who is enrolled in study. This case is submitted in accordance with post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this subject. The subject received FLUMIST on 14-Feb-2008. On 20-Mar-2008, the subject was admitted to the hospital with a one day history of cough and tachypnea. She was found to be hypoxic to the high 80's in the emergency department. Clinically with right lung inspiratory crackles, but also with a barking cough and radiographic evidence of croup (steeple sign). The subject received ceftriaxone as well as racemic epinephrine and decadron x1. The subject had a significant improvement with resolution of her tachypnea and hypoxia as well as improved air movement on the lung exam. The subject was discharged on 21-Mar-2008 with a course of amoxicillin for pneumonia. The subject's mother reported that at night following discharge, the subject seemed to be breathing harder but improved after using a humidifier. The events were considered resolved on 30-Mar-2008. The investigator assessed the pneumonia and croup as not related to FLUMIST. The sponsor assessed the relationship to FLUMIST as not related. Additional information was received on 16-Oct-2008 including: adverse onset date and resolution, rechallenge/dechallenge, suspect vaccine dose and lot#, medical and immunization history, lab and chest x-ray results.					Y	1			Y	02/14/2008	03/15/2008	30	20-Mar-2008: Chest x-ray: There are linear opacities at the lung bases which may be due to vascular crowding or atelectasis given lower lung volumes. No definite consolidation. Blood culture, 03/20/2008, No growth at 5 days; Eosinophil, 03/20/2008, 0%; Hematocrit, 03/20/2008, 36.4%; Hemoglobin, 03/20/2008, 13.1 g/dl; Lymphocyte, 03/20/2008, 12%; Neutrophil, 03/20/2008, 86%; Platelet, 03/20/2008, 399 K/uL; WBC count, 03/20/2008, 16.7 K/uL	OTH	OTH	Concomitant drug(s) not reported		No known allergies; Immunization history: 11-Jul-2005 - HBV; 28-Sep-2005 -DTP, HBV, HIB HbOC, PNUcn, POL-IPV; 16-Nov-2005 - DTaP-HBV-POL, HIB PRP-T, PNUcn; 17-Jan-2006 - DTaP-HBV-POL, HIB PRP-T, INFs, PNUcn; 15-Aug-2006, HIB PRP-T, MMR, PNUcn; 12-Apr-2007; DTaP, HAV, VAR		MEDI0007266	1						1	Blood culture negative; Chest X-ray abnormal; Cough; Crepitations; Croup infectious; Eosinophil percentage; Haematocrit normal; Haemoglobin normal; Hypoxia; Lymphocyte percentage decreased; Neutrophil percentage increased; Platelet count normal; Pneumonia; Tachypnoea; White blood cell count increased	FLUN3~MEDIMMUNE VACCINES, INC.~500499P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0335001	11/20/2008	CA	3.0	3		F	10/21/2008	A serious clinical trial report of acidosis, hypoglycemia, dehydration and acute gastroenteritis has been received from an investigator concerning a 46 month old female subject number 42453753, who is enrolled in study. Age in a Managed Care Setting. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The subject had a medical history that consisted of premature birth at 33 weeks: birth weight 3 lbs 15oz; in the ICN for three weeks with minimal respiratory difficulty on 02 per NC briefly and was tube fed: 3rd to 5th growth percentile: history of chronic diarrhea following acute illnesses; possible IBS, family history significant for possible IBS in paternal grandfather. The patient was taking psylilium 9 gram daily by mouth. The subject received FluMist on 25-Nov-2007. On 18 Dec 2007, the subject presented to the emergency department and it was noted that she was in her usual state of health until two days ago when she vomited four times. The day before her presentation, the subject had vomited three times and had taken on 10 oz of liquid and no solids. She had begun to experience intermittent crampy non-localized abdominal pain. She also had vomited two times the morning of 18-Dec-2007 and stools daily. The emesis had been non-bloody, but looked bile tinged. The subject was in daycare, but had no unusual foods, travel, foreign visitors or illness exposure. Temperature was 97.0, heart rate 15/min, respiratory rate 24/min, blood pressure 84/55, and oxygen saturation 100% on room air. Tympanic membranes were normal, lungs were clear to auscultation, and mucus membranes were moist. On 18 Dec 2007, laboratory results in the ER were as followed: K 5.4; NA 137; CL 103: C02 12: BUN 16: CREAT 0.41: GLUC 40: Anion gap 22: WBC 9.2; HGB 13.3; HCT 38.9: and PLT 350. On 18-Dec-2007, she was admitted to the hospital due to acidosis, hypoglycemia, dehydration, and acute gastroenteritis. A KUB showed midly dilated loops and the acidosis was noted to be secondary to dehydration. While hospitalized, the subject had no vomiting but did develop diarrhea. The hypoglycemia slowly improved after IV fluids although the glucose was still 50 and C02 was 13 after receiving IV fluid for six to eight hours. After 12 hours, the glucose was 87 and C02 was 22; the blood sugar remained stable while weaning off the IV and she was taking small amounts of a fluid/brat diet. Her stool was negative for WBC. The subject was discharged from the hospital on 19 Dec 2007. The events were resolved on 19-Dec-2007. The investigator assessed the acidosis, hypoglycemia dehydration, and acute gastroenteritis as not related to FluMist. The sponsor assessed the relationship to FluMist as not related. Follow-up information received 21-Oct-2008 and incorporated into the narrative: D/C summary with laboratory results. A serious clinical trial report of acidosis, hypoglycemia, dehydration, and acute gastroenteritis has been received from an investigator concerning a 46-month-old female who is enrolled in study. This case is submitted in accordance with Medimmune's post marketing conmomitent anaccelerated reporting for the newley indicated population of 2 years to 59 months of age for FLUMIST. The subject had a medical history that consisted of premature birth at 33 weeks: birth weight 3 lbs 13 oz: in the ICN for three weeks with minimal respiratory difficulty on 00 per NC briefly and was tube fed; 3rd to 5th growth percentile; history of chronic diarrhea following acute illnesses; possible IMS; family history significant for possible IBS in paternal grandfather. The patient was taking PSYLLIUM 9 grams by mouth. The subject received FLUMIST on 28-NOV-2007. On 18-Dec-2007, the subject presented to the emergency department and it was noted that she was in her usual state of health until two days ago when she vomited four times. The day before her presentation, the subject had vomited three times and had taken on 10 oz of liquid and no solids. She had begun to experience intermittent crampy non-localized abdominal pain. She also had vomited two times the morning of 12/16/2007 and while in the ED, No stools had been noted for the past four days whereas, prior to 14-Dec-2007 she had formed stools daily. The emasis had been non-bloody, but looked bile-tinged. The subject was in daycare, but had no unusual foods, travel, foreign visitors or illness exposure. Temperature was 97.0, heart rate 115/min, respiratory rate  24/min, blood pressure 84/85, and oxygen saturation 100% on room air. Tympasic membranes were normal, lungs were clear to ousculation, and mucus membranes were moist. On 18-Dec-2007, laboratory results in the ER were as followed: R. 5.40 NA 137: OL 103: CO2 12: BUN 16: CREAT 0.41: GLUC 40: Anion sup 22: WBC 9.2: RUD12.3: GCT 38.7 and FLY 359. On 19-Dec-2007, she was admitted to the hosital due to acidosis, hypoglycemia dehydration, and acute gastroenteritis. A KUS showed mildly dilated loops and the acidosis was noted to be secondary to dehydration. While hospitalized, the subject had no vomiting but did develop diarrhea. The hypoglycemia slowly improved after IV fluids althouth the glucos was still 50 and CO2 was 13 after receiving IV fluid for six to eight hours. After 12 hours, the glucose was 83 and CO2 was 22: the blood sugar remained stable while weaning off the IV and she was taking small amounts of fluid/tuat diet. Her stool was negative for WBC. The subject was discharged from the hospital on 19-Dec-2007. The events were resolved on 19-Dec-2007. The investigator assessed the acidosis, hyperglycemia dehydration, and acute gastroenteritis as not related to FLUMIST. The sponsor assessed the drelationship to FLUMIST as not related. Follow-up information received 21-Oct-2008 and incorporated into the narrative: D/C summary with laboratory results. Follow-up information received on 27-Aug-2009 clarified the events set serious criteria on 18-Dec-2007.					Y	1			Y	11/28/2007	12/15/2007	17	Anion Gap 12/18/07 22; BUN 12/18/07 16; CL 12/18/07 103; C02 12/18/07 12; NI 13; NI 22, CREAT 12/18/07 0.41; GLUC 12/18/07 40; GLUCOSE NI 50; NI 87; HCT 12/18/07 38.9; HGB 12/18/07 13.3; K 12/18/07 5.4; KUB NI Mildly dilated loops; NA 12/18/07 137; PLT 12/18/07 350; WBC 12/18/07 9.2.	OTH	OTH	METAMUCIL		Born at 33 weeks: birth weight 3 lbs 15 oz; Was in the ICN for three weeks with minimal respiratory difficulty on 02 per NC briefly and tube fed. In 3rd to 5th growth percentile, Chronic diarrhea following acute illnesses; possible IBS; lactose intolerance; Family history significant for possible IBS in paternal grandfather. Past Disease: Prematurity; Poor weight gain.		MEDI0007269	1						1	Abdominal pain; Acidosis; Anion gap increased; Blood chloride normal; Blood creatinine normal; Blood glucose decreased; Blood potassium increased; Blood sodium normal; Blood urea normal; Carbon dioxide decreased; Dehydration; Gastroenteritis; Haematocrit normal; Haemoglobin normal; Hypoglycaemia; Infrequent bowel movements; Irritable bowel syndrome; Platelet count normal; Urinary system X-ray; Vomiting; White blood cell count normal; X-ray abnormal	FLUN3~MEDIMMUNE VACCINES, INC.~IN500496P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0335002	11/20/2008	CA	2.0	2	.5	F	10/20/2008	A serious clinical trial report of osteomyelitis has been received from an investigator concerning a 29-month-old female, subject number 28398632, who is enrolled in study.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  On the day of vaccination and for several days prior to vaccination, the subject's right foot was noticeably swollen and tender: and she walked with a limp despite no known injury.  The subject had no concomitant medications and no known allergies.  The subject received FLUMIST on 26-Nov-2007 intranasally for influenza vaccination.  On 26-Nov-2007, the day she received the FLUMIST vaccine, it was noticed that the right foot was swollen, tender, and the subject was limping.  The subject was seen in the ER and a slight improvement was noted since a previous ER visit.  On examination at the ER, slight swelling of the dorsum foot was noted with some limping, no ankle swelling and normal ROM.  Her axillary temperature was 98.4 degrees Fahrenheit.  X-rays of the right foot were taken on 18-Nov-2007 and 11-Dec-2007, both showed no overt fracture, no malaligment and no emphysema.  On 12-Dec-2007, an office visit revealed continued swelling and limping, discoloration of dorsum of right foot, no fever or other symptoms.  The subject was referred to podiatry.  On 14-Dec-2007, a MRI revealed an aggressive lesion in the medial cuneiform, concerning for infection.  However, given the relative lack of elevated white count and other clinical symptoms of infection, other neoplastic etiologies such as leukemia, eosinophilic granuloma, or sarcoma could not be excluded.  There was guestionanle edema in the ascending cuneiform and involvement of the bone was not excluded.  On 22-Dec-2007, the subject was admitted to the hospital for the management and treatment of a presumed right foot cateomyelitis.  On the date of admission, the subject had the following laboratory results: neutrophils 31% (80-70%); eosinophils 5% (0-4%), and ESR 25 mm/Hr (0-20 mm/Hr).  Upon admission, an IV was started for antibiotics after a debridement of her right cuneiform bone.  The cultures were negative.  The subject was started on CELAZOLIN IV which was continued for seven days.  The hospital stay was without complications.  The subject was discharged from the hospital on 28-Dec-2007, after seven days of IV antibiotics then ordered to complete a two week course of CEPHALEXIN orally.  The subject was doing well at discharge.  On 28-Jan-2008, the subject presented for an office visit to follow up the CETEOMYELITIS of the right medial cuneiform.  The subject was noted to be doing well, no limp or complications of pain, no fever or swelling.  The right medial foot had healed well with no signs of infection or swelling.  New X-rays revealed all foot bones to be normal.  The assessment showed the osteomyclitic of the right medial cuneiform to be resolved.  The event was resolved on 28-Jan-2008.  The investigator assessed the osteomyelitis as not related to FLUMIST.  The sponsor assessed the relationship to FLUMIST as not related.  Follow-up information received 20-Oct-2008 and incorporated into the narrative: D/C summary and laboratory results.					Y	7			Y	11/26/2007	11/26/2007	0	14-Dec-2007 - MRI of the right foot: Aggressive lesion in the medial cuneiform, concerning for infection.  However, given the relative lack of elevated white count and other clinical symptoms of infection, other neoplastic etiologies, such as leukemia, eosinophilic granuloma, or sarcoma are not excluded.  Questionable edema in the second cuneiform.  Involvement of this bone is also not excluded; Cultures, NI, Negative; Eosinophils, 12/22/07, 5%; ESR, 12/22/07, 25 mm/Hr; Neutrophils, 12/22/07, 31%; X-ray, NI, All foot bones normal; X-ray right foot, 11/18/07, No overt fracture; No malalignment; No emphysema; 12/11/07, No overt fracture; No malalignment; No emphysema	OTH	OTH	Concomitant Drug(s) Not Reported.		No known allergies		MEDI0007270	1						1	Condition aggravated; Culture negative; Eosinophil percentage increased; Gait disturbance; Neutrophil percentage decreased; Nuclear magnetic resonance imaging abnormal; Oedema peripheral; Osteomyelitis; Red blood cell sedimentation rate increased; Skin discolouration; Tenderness; X-ray normal	FLUN3~MEDIMMUNE VACCINES, INC.~500496P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0335003	11/20/2008	CA	3.0	3		F	10/06/2008	A serious post-marketed study report of dehydration, pneumonia and acute gastroenteritis has been received from a study investigator concerning a 36-month old female subject, patient ID 43450393, participating in a post marketing study. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this subject. The subject received FLUMIST on 14-Dec-2007. On 09-Jan-2008, the subject was hospitalized for dehydration, pneumonia and acute gastroenteritis. The outcome is unknown. The investigator assessed the events of dehydration, pneumonia and acute gastroenteritis as not related to FLUMIST. The sponsor assessed the relationship of the events of FLUMIST as not related.					Y				U	12/14/2007	01/09/2008	26		OTH	OTH	Not Reported				MEDI0007271	1						1	Dehydration; Gastroenteritis; Pneumonia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0335004	11/20/2008	CA	4.0	4		M	10/06/2008	A serious post-marketed study report of hydronephrosis and ureteritic obstruction has been received from a study investigator concerning a four-year old male subject, patient ID 53390614, participating in a post-marketing study. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this subject. The subject received FLUMIST on 18-Oct-2007. On 05-Nov-2007, the subject was hospitalized for hydronephrosis and ureteric obstruction. The subject's length of hospital stay was two days. The outcome is unknown. The investigator assessed the events of hydronephrosis and ureteric obstruction as not related to FLUMIST. The sponsor assessed the relationship of the events as not related to FLUMIST.					Y	2			U	10/18/2007	11/05/2007	18		OTH	OTH	Not Reported				MEDI0007272	1						1	Hydronephrosis; Ureteric obstruction	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0335006	11/20/2008	PA	3.0			F	10/03/2008	A non-serious spontaneous report of abrasion and nose bleed has been received from a registered nurse concerning a 46-month old female patient subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No relevant medical and drug history were reported for this patient. The patient received FLUMIST via nasal route on 03-Oct-2008. The patient developed nose bleed after FLUMIST administration. The patient received the initial dose without any problem. The patient was reportedly moving after FLUMIST administration into the other nostril. According to the reporter, there was a possibility of an abrasion inside the second nostril from the FLUMIST syringe tip resulting in nose bleed. The outcome of the adverse events was not reported.									U	10/03/2008	10/03/2008	0		PVT	OTH	Not Reported				MEDI0007178	1						1	Epistaxis; Excoriation	FLUN3~MEDIMMUNE VACCINES, INC.~500544P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335007	11/20/2008	OH	2.0			F	10/07/2008	A non-serious, spontaneous report of red skin all over, fever, fatigue and runny nose was received from a sales representative concerning a two year old female patient, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing committment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 03-Oct-2008. On 04-Oct-2008 the child had symptoms of a fever of 104.7 F, fatigue, red skin all over and was seen by a local health provider. On 06-Oct-2008 the child was evaluated again and the fever had declined to 100.7 F, red skin had resolved and the only other symptom was a runny nose. No further information was provided.									Y	10/03/2008	10/04/2008	1	Body temperature, 10/04/08, 104.7 F; 10/06/08, 100.7 F	OTH	OTH	Not Reported				MEDI0007202	1						1	Body temperature increased; Fatigue; Generalised erythema; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335008	11/20/2008	IN	0.5			M	10/21/2008	A non-serious spontaneous report of inadvertent administration to six-month-old infant has been received from a Registered Nurse concerning a six-month-old male subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medication were not reported. On 07-Oct-2008, the physician's office inadvertently gave FLUMIST to a six-month old infant. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow up information received on 21-Oct-2008, 14 days after the patient received FLUMIST. indicated that there were not adverse events.									Y	10/07/2008	10/07/2008	0		PVT	OTH	Not Reported				MEDI0007206	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500547P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335009	11/20/2008	NC	3.0			F	10/08/2008	A non-serious spontaneous report of fever has been received from a consumer (patient's mother) concerning a 36-month-old female subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical or medication history was reported for this patient. The patient received FLUMIST on 29-Sep-2008. On 07-Oct-2008, the patient developed a high fever of 104.7 degrees Fahrenheit. The patient was not seen by a health care provider. The outcome of the adverse event was not reported.									U	09/29/2008	10/07/2008	8		OTH	OTH	Not Reported				MEDI0007209	1						1	Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335010	11/20/2008	IN	0.6			U	10/08/2008	A non-serious report  of dosing error has been received from a pharmacist concerning a seven-month old infant. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical and medication history were not reported. The patient received FLUMIST on 08-Oct-2008. There were no immediate clinical problems or adverse events noted from the dosing error. There was no immediate clinical problems or adverse events noted from the dosing error. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	10/08/2008	10/08/2008	0		OTH	OTH	Not Reported				MEDI0007236	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335011	11/20/2008	NE	4.0			F	10/11/2008	A non-serious, spontaneous report of rash with pustule on top and hives was received from a consumer concerning a four year-old female patient subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 08-Oct-2008. After administration the child developed a rash and hives on the neck and face. The mother took the child to the pharmacist who prescribed OTC ZYRTEC. The rash and hives subsided, but the child still has two areas of small pencil head size spots with a pustule on top. The spots are located next to the eye and beside the lips.										10/08/2008	10/11/2008	3		OTH	OTH	Not Reported				MEDI0007249	1						1	Rash pustular; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335012	11/20/2008	AL	1.8			M	10/13/2008	A non-serious report of dosing error (FLUMIST administered to 22 month infant) has been received from a Registered Nurse concerning a 22 month old male. This case is submitted in accordance with MedImmune's post-marketing committment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 13-Oct-2008, the patient was inadvertently administered  a half dose of FLUMIST (single nostril). When it was discovered the patient was less than 24 months old, it was decided to not administer the other half dose. The patient showed no reactivity to the half dose. The clinic planned to administer TIV at that time and the booster later since this was the first time the patient received an influenza vaccine. There was no adverse event reported with this vaccination error; therefore; treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved									Y	10/13/2008	10/13/2008	0		OTH	OTH	Not Reported				MEDI0007250	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500574P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335013	11/20/2008	SC	0.5			M	10/14/2008	A non-serious, spontaneous report of six month-old received FLUMIST, fever and loss of appetite was received from a nurse concerning a six month-old male patient, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 11-Oct-2008. As reported on 14-Oct-2008, the child has had symptoms of fever and decreased appetite since vaccination. The outcome for the reported adverse events was not reported.									Y	10/11/2008	10/11/2008	0		OTH	OTH	Not Reported				MEDI0007256	1						1	Anorexia; Inappropriate schedule of drug administration; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500559P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335014	11/20/2008	NJ	2.0			F	10/14/2008	Inappropriate dose of vaccine administered.									Y		10/10/2008			UNK	UNK	Not Reported				MEDI0007257	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335016	11/20/2008	MO				M	10/16/2008	A non-serious spontaneous report of ears hurting bad has been received from a Pharmacist concerning a male child, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history or concomitant medications were reported. The patient received one dose of FLUMIST on 16-Oct-2008. Thirty minutes after the patient received FLUMIST he returned to the pharmacy screaming stating that his ears hurt. The child stated that his, ears are hurting bad. The Pharmacist described the event as tinnitus. The outcome of the event was not reported. The causality of the event was not reported.									U	10/16/2008	10/16/2008	0		OTH	OTH	Not Reported				MEDI0007280	1						1	Ear pain; Tinnitus	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335017	11/20/2008	KY	1.9			M	10/16/2008	A non serious spontaneous report of administration to a 21 month-old male was received from a pediatrician's office. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.									Y	10/16/2008	10/16/2008	0		OTH	OTH	Not Reported				MEDI0007281	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335018	11/20/2008	MO	1.9			M	10/16/2008	A non serious spontaneous report of administration to a child of 1 year and 11 months of age was received from a registered nurse concerning a 23- month old male patient. No medical history or medication history was reported for this patient. The patient received FLUMIST on 15-Oct-2008. The patient will not be turning two until 02-Nov-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.									Y	10/15/2008	10/15/2008	0		PVT	OTH	Not Reported				MEDI0007283	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335019	11/20/2008	IL	0.5			F	10/17/2008	A non-serious spontaneous report of administration to infant under 2 years old has been received from a Nurse Practitioner concerning a six-month-old female, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment of accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. During the week of 10-Oct-2008 through 13-Oct-2008, FLUMIST was administered to four infants under two years old, including this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	10/01/2008	10/01/2008	0		OTH	OTH	Not Reported				MEDI0007286	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335020	11/20/2008	IL	0.8			F	10/17/2008	A non-serious spontaneous report of administration to infant under 2 years old has been received from a Nurse Practitioner concerning a nine-month-old female, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. During the week of 10-Oct-2008 through 13-Oct-2008, FLUMIST was administered to four infants under two years old, including this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	10/01/2008	10/01/2008	0		OTH	OTH	Not Reported				MEDI0007287	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335021	11/20/2008	IL	0.5			F	10/17/2008	A non-serious spontaneous report of administration to infant under 2 years old has been received from a Nurse Practitioner concerning a six-month-old female, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. During the week of 10-Oct-2000 through 13-Oct-2008, FLUMIST was administered to four infants under two years old, including this patient. There was no adverse event associated with this medication error, therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	10/01/2008	10/01/2008	0		OTH	OTH	Not Reported				MEDI0007288	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335022	11/20/2008	IL	1.3			F	10/17/2008	A non serious spontaneous report of administration to infant under 2 years old has been received from a Nurse Practitioner concerning a fifteen-month-old female, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. During the week of 10-Oct-2008 through 13-Oct-2008, FLUMIST was administered to four infants under two years old, including this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	10/01/2008	10/01/2008	0		OTH	OTH	Not Reported				MEDI0007289	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335023	11/20/2008	FL	3.0			F	10/17/2008	A non-serious report of runny nose and fever has been received from a parent of the patient concerning a 36 month old female subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history or concomitant medications were reported. The patient received FLUMIST on 13-Oct-2008. The patient received a total of one dose before onset of the events two days after their only doses of FLUMIST. The mother of the patient reported that two days after receiving FLUMIST the patient developed a runny nose on 15-Oct-2008. The following day 16-Oct-2008 the patient developed a fever. The mother reported that on 17-Oct-2008 the patient was symptoms free.									Y	10/13/2008	10/15/2008	2		OTH	OTH	Not Reported				MEDI0007290	1						1	Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335024	11/20/2008	CO	4.0			M	10/30/2008	Incorrect dose administered. A non serious spontaneous report of dosing error (gave half of the vaccine) was received from a RN concerning a four-year old male patient. The patient has no relevant medical history. The patient was not taking any medications at the time of the event. The reporter did not remember removing the clip from the FLUMIST pre filled syringe and thinks that the only one-half dose of the vaccine was given, three times total, to a family that included a mother and her two sons. Upon follow-up, the reporter confirmed that there was no adverse event associated and the event is considered resolved. This case is submitted in accordance with post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information was obtained on 30-Oct-2008 and incorporated into the narrative: Confirmation from the reporter that no adverse evens occurred from the dosing error gave half of the vaccine.									Y	10/17/2008	10/17/2008	0		OTH	PVT	Concomitant drug(s) not used				MEDI0007295	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335025	11/20/2008	NC	3.0	3		U	10/21/2008	A non serious spontaneous report of vomiting has been received from a registered nurse concerning a three-year old patient of unknown gender subsequent to FLUMIST. This case is submitted in accordance with Medimmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history or medication history was reported for this patient. The patient received FLUMIST on 21-Oct-2008. The patient vomited within a couple of hours after receiving FLUMIST. Per the reporter, approximately 600 doses were administered at the site; she does not believe the product is bad and does not want to return the last five doses at the site. The outcome of the event is unknown.									U	10/21/2008	10/21/2008	0		OTH	OTH	Not Reported				MEDI0007309	1						1	Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500541P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335026	11/20/2008	NC	4.0	4		U	10/21/2008	Vomiting A non-serious spontaneous report of vomiting has been received from a registered nurse concerning a four-year old patient subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history or medication history was reported for this patient. The patient received FLUMIST on 21-Oct-2008. The patient vomited within a couple of hours after receiving FLUMIST. Per the reporter, approximately 500 doses were administered at the site; she does not believe the product is bad and does not want to return the last five doses at the site. The outcome of the event is unknown.									U	10/21/2008	10/21/2008	0		OTH	OTH	Not Reported				MEDI0007310	1						1	Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335027	11/20/2008	CA				U	10/21/2008	Fever A spontaneous non-serious report of fever of less than 101 has been received from a physician in the USA concerning a child of unknown age and gender. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history nor concomitant medications were provided. On an unknown date, the patient received a dose of FLUMIST. The physician reported the event of fever of less than 101 three days after FLUMIST. Per the reporter, the patient was a young child: no demographics were available at the time of this report. The child had no other significant symptoms. Outcome for the events was not provided by the reporter.									U					OTH	OTH	Not Reported				MEDI0007312	1						1	Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335028	11/20/2008	OR	3.0			M	10/22/2008	Shaking Irritability Fever Feeling unwell A non-serious report of shaking, fussiness, fever of 102, and not feeling right has been received from a pharmacist in the USA concerning his son, a three-year-old male. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history nor concomitant medications were provided. On 15-Oct-2008, the patient received a dose of FLUMIST. Two days after the dose of FLUMIST, the patient developed a fever of 102 degrees and had symptoms of being fussy. The patient received ibuprofen and acetaminophen and the fever went away. The patient also experienced shaking and not feeling right. The patient has not seen a physician for medical evaluation. The event of fever of 102 resolved on 20-Oct-2008; the events of shaking and not feeling right were still ongoing and the outcome for the event of fussiness was not provided by the reporter.										10/15/2008	10/17/2008	2		OTH	OTH	Not Reported				MEDI0007321	1						1	Irritability; Malaise; Pyrexia; Tremor	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335029	11/20/2008	PA	3.0	3		M	10/22/2008	A non-serious report of fever, runny nose, and right foot limping and dragging has been received from a physician concerning a three-year-old male. This case is submitted in accordance with MedImmune's post marketed commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history nor concomitant medications were provided. The patient received FLUMIST on 18-Oct-2008. On 18-Oct-2008, the patient was administered FLUMIST at a local pharmacy. On the evening of 19-Oct-2008, the patient developed symptoms of fever and runny nose. On 20-Oct-2008, the patient exhibited symptoms of limping on his right leg and dragging of his right foot. The patient did not complain of pain and was not hospitalized but was seen by a physician however, after being examined by a physician's diagnosis could not be determined. X-rays and neurological work up were performed, results were normal. The reporter confirmed that the patient did not fall or experience any incident which may have affected his leg. The patient's father, who is also a physician reported the neurological events in his son and requested additional information on the product. Per the report, his son was doing well, the event improved but was still ongoing. The causality was assessed as not related but the reporter believes that there was a temporal association.										10/18/2008	10/19/2008	1	Neurological work up, Normal; X-rays, 10/??/08, Normal	OTH	OTH	Not Reported				MEDI0007322	1						1	Gait disturbance; Neurological examination normal; Pyrexia; Rhinorrhoea; X-ray normal	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335030	11/20/2008	MD	2.0	2	.5	M	10/21/2008	Spaced out Fever Runny nose A non-serious spontaneous report of spacey, feverish and runny nose has been received from a consumer (patient's mother) concerning a 30-month-old male patient, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's past medical history includes seasonal allergies since April 2008. No concomitant medications were reported for this patient. The patient received his first dose of FLUMIST intranasally on 08-Aug-2008. The patient was described as feverish, spacey and had a runny nose for the next three days after receiving FLUMIST. The patient was not evaluated by a physician for his symptoms. The patient experienced the events from 08-Aug through 11-Aug-2008. The patient did not receive another dose of FLUMIST.									Y	08/08/2008	08/08/2008	0		OTH	OTH	Not Reported	Seasonal allergy			MEDI0007324	1						1	Feeling abnormal; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335031	11/20/2008	IA				F	10/23/2008	Incorrect dose administered A non-serious spontaneous report of patient given only half a dose of FLUMIST was received from a registered nurse in the USA concerning a female child. Neither medical history nor concomitant medications have been reported. The nurse who administered the FLUMIST forgot to remove the divider clip from the plunger of the spray device and delivered only half a dose to the patient. There was no adverse event associated with this medication error: therefore, treatment and reporter/sponsor causal assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.									Y	10/21/2008	10/21/2008	0		PVT	OTH	Not reported				MEDI0007326	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~500557P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335032	11/20/2008	MN	2.0			F	10/23/2008	Inappropriate schedule of vaccine administered (Inappropriate schedule of drug administration) A non-serious spontaneous report of a second dose of FLUMIST given two weeks after the first dose to a two-year-old female child has been received from a Registered Nurse in the USA. This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medication were not reported. On 09-Oct-2008, the physician's office gave FLUMIST to the child and on 23-Oct-2008 a second dose of FLUMIST was given to the same child. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information received on 13-Jan-2009 confirmed the child has not experienced any adverse events.									Y	10/09/2008	10/23/2008	14		OTH	OTH	Not Reported				MEDI0007327	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500558P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335033	11/20/2008	OR	1.49	1	.5	F	10/24/2008	Vaccination error (Medication error) A non-serious, spontaneous report of 17-month-old female was given FLUMIST was received from a pharmacist in the United States. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received 12-Nov-2008. There were no events reported for the patient since vaccination.									Y	10/24/2008	10/24/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007332	1						1	Inappropriate schedule of drug administration; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500543P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335034	11/20/2008	UT	4.0			U	10/24/2008	Expired vaccine used A non-serious spontaneous report of administered expired FLUMIST was received from a health care worker in the USA concerning a four-year-old child. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history was provided. The reporter indicated that outdated FLUMIST was administered to two children on 24-Oct-2008 [expiration date 10-Jan-2008). The patient's were re-administered the flu shot. Upon follow up the reporter stated no adverse events were associated with this expired vaccine usage; therefore, treatment and causality assessments are not applicable, and the event is considered resolved. Follow-up information received on 24-Mar-2009 included Product Complaint Investigation results.									Y	10/24/2008	10/24/2008	0		OTH	OTH	Not Reported				MEDI0007336	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~50047P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335035	11/20/2008	NY	2.0			M	10/27/2008	A non-serious spontaneous report of erythema multiforme has been received from a Registered Nurse concerning a two year-old male subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient received FLUMIST on 21-Oct-2008. The patient received a total of one dose before onset of the event which occurred three days later. On 24-Oct-2008 the child was diagnosed with erythema multiforme. It was described as raised lesions on buttocks, legs and abdomen. The event remains unresolved with the rash present.										10/21/2008	10/24/2008	3		OTH	OTH	Not Reported				MEDI0007338	1						1	Erythema multiforme; Skin lesion	FLUN3~MEDIMMUNE VACCINES, INC.~500567P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335036	11/20/2008	IA				M	10/23/2008	Vaccination error (Medication error) A non-serious spontaneous report of patient given only half a dose of FLUMIST was received from a registered nurse in the USA concerning a male child. Neither medical history nor concomitant medications have been reported. The nurse who administered the FLUMIST forgot to remove the divider clip from the plunger of the spray device and delivered only half a dose to the patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.									Y	10/21/2008	10/21/2008	0		PVT	OTH	Not Reported				MEDI0007339	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~500557P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335037	11/20/2008	ND	4.0			M	10/28/2008	A serious spontaneous report of Bell's Palsy has been received from a physician concerning a four year-old male subsequent to FLUMIST. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient had a recent infection in his mouth from Herpes virus. Concomitant medications were not reported. On 24-Oct-2008, the patient received FLUMIST. The lot of the vaccine came from an Air Force base. One and a half hours after FLUMIST administration, the patient experienced Bell's Palsy with symptoms of inability to close left eye, decrease in sensation on left side of face, and an unsymmetrical smile. As of 28-Oct-2008, the patient showed minimal improvement. The sponsor considered Bell's Palsy to be serious important medical event. The reporting physician did not thin there was a cause and effect relationship.										10/24/2008	10/24/2008	0		OTH	OTH	Concomitant drug(s) not reported	Herpes virus infection			MEDI0007346	1						1	Facial palsy	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335038	11/20/2008	WV	3.0			F	10/29/2008	A non-serious spontaneous report of FLUMIST got into child's eye was received from a nurse concerning a female child.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Follow up: A non-serious report of FLUMIST got into child's eye was received from a nurse in the USA concerning a three year old female. There was no adverse event associated with this medication error at the time of the report, not on 07 JAN 2009 when the the reporter was contacted: therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Additional information received on 07-Jan-2009 and incorporated into narrative: no adverse events occurred.									Y	10/29/2008	10/29/2008	0		OTH	OTH					MEDI00073460	1						1	Accidental exposure; Accidental exposure	FLUN3~MEDIMMUNE VACCINES, INC.~IN500554P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335039	11/20/2008	OH	3.0			M	10/31/2008	A non-serious, spontaneous report of hives over entire body was received from a nurse, concerning a 36-month-old male subsequent to FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 50 months of age for FLUMIST.  Neither relevant medical history nor concomitant medications have been reported for this patient.  The patient received FLUMIST on 30-Oct-2008.  Within a few hours the child developed hives over his entire body.  DIPHENHYDRAMINE liquid was administered and the hives cleared.									Y	10/30/2008	10/30/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007359	1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~IN500553P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335040	11/20/2008	UT	0.8			M	10/30/2008	A non-serious spontaneous report of FLUMIST given to a nine-month old was received from a certified medical assistant in a physician's office concerning a nine-month-old male.  The patient's medical history and concomitant medications were not reported.  On 29-Oct-2008, the patient received FLUMIST vaccine, which is only approved for patients ages 24 months to 39 years of age.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.									Y	10/29/2008	10/29/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007361	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~IN500545P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335108	11/20/2008	NV	4.0			M	10/07/2008	A non-serious, spontaneous report of partial dose of FLUMIST given in a four-year old male patient was received from a pharmacist.  There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.									Y	10/07/2008	10/07/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007238	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~IN500562P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335109	11/20/2008	NJ	2.0	2	.7	M	10/08/2008	A non-serious, spontaneous report of partial dose of FLUMIST administered was received from a physician concerning her 32-month-old son.  This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  The patient's medical history and concomitant medications was not reported.  The physician reported that she was not trained in FLUMIST administration hence, she did not remove the divider clip when administering FLUMIST.  She complained that the syringe did not state clear instructions on administration such as removal of clip and to use both nostrils.  There was no adverse event reported; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	10/08/2008	10/08/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007241	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335110	11/20/2008	NE	3.0			F	10/09/2008	A non-serious report of wheezing has been received from a nurse concerning a three-year-old female subsequent to FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  No relevant medical history has been reported for this patient; however, the patient did not have a history of asthma, allergies of wheezing.  The patient's concomitant medications includes: TIV in 2006.  The subject received her first dose of FLUMIST on 30-Sep-2008.  On 09-Oct-2008, the mother of the three year old patient called the office indicating that the child experienced wheezing after receiving FLUMIST on 30-Sep-2008; the wheezing lasted for about 30-minutes and then resolved without reoccurrence.  The patient was doing well and the event resolved.  Per the reporter, they do not recommend that the patient receive the vaccine next year.									Y	09/30/2008	09/30/2008	0		PVT	OTH	Concomitant Drug (s) Not Reported		TIV in 2006 (not sure if booster was given at that time) : no record of vaccine given to child in 2007; No allergies		MEDI0007245	1						1	Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~IN500563P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335111	11/20/2008	WA	3.0			M	10/10/2008	A non-serious report of nose bleed has been received from a nurse concerning a three-year-old male subsequent to FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  No relevant medical history or concomitant medications have been reported for this patient.  The subject received a dose of FLUMIST on 09-Oct-2008.  On 09-Oct-2008, the patient experienced nose bleed after administration of FLUMIST into the the second nostril.  Per the reporter, the patient was moving about during the administration.  The outcome for this event was not reported.									U	10/09/2008	10/09/2008	0		PVT	OTH	Concomitant Drug (s) Not Reported				MEDI0007247	1						1	Epistaxis	FLUN3~MEDIMMUNE VACCINES, INC.~IN500557P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0332944	11/21/2008	CA		9		F	11/21/2008	injection site rash				Y					Y	10/01/2008	10/03/2008	2	none	PVT	PVT	none	cough	none			1						1	Injection site rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~unk~1~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0332950	11/21/2008	IA	55.0	55		F	11/20/2008	Shot received 0900 on 11/18/08 during NOC of 11/18/08 had chills, severe convulsions and arm so sore couldn't use - really nauseous, also all NOC long. 11/19/08 felt flulike all day and 11/20/08.									U	11/18/2008	11/18/2008	0		PVT	OTH		None			IA08019	1						1	Chills; Convulsion; Influenza like illness; Nausea; Pain in extremity	FLU3~SANOFI PASTEUR~U2740AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0742X~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332953	11/21/2008	NM	55.0	55		M	11/14/2008	Approximately 9:00AM rec'd shot on 11/3/08. Around 4:00 started feeing sick, chills down spine, aching. Condition got worse with fever of 101. Called Dr, he said to take 2 Tylenol this was around 7PM-Had taken 2 Advil's around 5:00 too. Sick all night. Armpit started swelling, and hurting that evening too. Continued with Advil and Tylenol all day Tuesday. Wed AM went to Dr. office. He stated I was having a reaction to shot. Gave Cephalexin 500mg and Hydrocodone APAP5-500. Had fever of 102 deg through Thursday 11/6/08. With a lot of pain in armpit and redness and fever at shot site, area of redness size of palm of hand. Lack of energy and weakness continued through Saturday 11/8/08. Arm is still sore today 11/14/08.				Y					U	11/03/2008	11/03/2008	0		OTH	UNK	Celebrex 200mg 1 x daily	None				1						1	Asthenia; Axillary mass; Axillary pain; Chills; Injection site erythema; Injection site warmth; Local reaction; Malaise; Pain; Pyrexia; Swelling	FLU3~SANOFI PASTEUR~U2804AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1076X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332955	11/21/2008	IL	70.0	70		F	11/20/2008	Patient received PNEUMOVAX sub cu in out aspect of (R) upper arm. She experienced local reaction 25x8cm with swelling erythema and tenderness.									N	11/14/2008	11/14/2008	0	None	OTH	PVT		None				1						1	Erythema; Local reaction; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U2849~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0554U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0332967	11/21/2008	VA	69.0	69		M	11/19/2008	16 days after receiving flu vaccine in 2005 (1st time ever receiving it) at 69 yrs of age, pt came down with a bad case of shingles, followed by RHN, which resulted in numb sole of foot and drop foot. He was seen in hospital for diagnosis, and neurologist was attending physician through several month's ordeal. Follow-up Information: Recovered from shingles but RHN remains - already 3yrs. Letter from patient: Thank you for affording me the opportunity to report the ill effects that might have been the result of the flu vaccine in October 2005.   1/5/09 Records received for 3 ER visits- 10/6/05 with Dx:  Acute shingles. Pt presented with 3 day hx of R leg pain, blistery rash and leg numbness. TX with Valtrex and pain meds. Returned 11/29/05 with c/o continued R leg pain 2' to shingles. DX: Post herpetic Neuralgia. Returned 12/5/05 with DX: Constipation 2' to pain meds. 2/18/09 MR received from neurologist for multiple OVs for post-herpetic neuralgia and Probable lower LS plexitis 2' to Zoster infection. Follow-up: Would love to know if you are seeing other cases of shingles, post flu shot. Post-Herpetic Neuralgia on sole of foot, which is the result of a very bad case of shingles. The patient, my husband developed shingles 16 days after receiving the flu shot; his first. I think it's very suspicious that after receiving the flu shot, which takes 14 days to take effect, that pt became very very ill with shingles. That can be proven documented in hospital and by his personal physician. Pt couldn't work for two months, and carried a cane for 4 months. Pain has subsided, but sole of right foot is numb and muscle in leg is weakened. Follow-up Information 09-DEC-2008: 16 days after recieving flu vaccine, in Oct of 2005, 69 yr old male recipient developed serious case of shingles. Neurologist was in chg. Physical therapy, because of derop foot prescribed for months and pain meds. Left w neuropathy from shingles, but foot is damaged.				Y				Y	U	10/13/2005	10/29/2005	16	Labs and Diagnostics:  EMG/NCS (+) for R peripheral neuropathy	PUB	UNK	Retinol; Tenormin; HTCZ - Diuretic; Hypertension meds	None	Hypertension			1						1	Herpes zoster; Hypoaesthesia; Impaired work ability; Muscular weakness; Neuropathy peripheral; Peroneal nerve palsy; Post herpetic neuralgia; Rash; Walking aid user	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0332972	11/21/2008	CA	48.0	48		F	11/08/2008	1 day after receiving the ADACEL vaccine, noticed raised, red, elevated area distal medial to injection site, warm.									U	11/03/2008	11/04/2008	1		PUB	PVT	Oral Contraceptive	None	None			1						1	Erythema; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U2758AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2994BA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0332973	11/21/2008	GA	57.0	57		F	11/04/2008	Admitted to hospital on 11/13/08 with complaint of weakness. Onset over last 10-14 days, becoming gradually worse, probable Guillain-Barre syndrome.   12/18/2008 MR received for DOS 11/3-9/2008 with D/C DX:  Guillain-Barre Syndrome.  Acute Renal Failure 2' to dehydration.  Dehydration 2' to diarrhea.  Constipation 2' GBS.  Hypertension.  Osteoarthritis. Pt presented to ER with progressive weakness x 10-14 days.  Admitted for concern for GBS. Symptoms were preceded by 4 days of diarrhea. Pt reports pins and needles sensations beginning in her feet and progressing up the legs to waist. PE (+) for diminished strength and sensation of lower extremities 3/5. Upper 4/5. Pt started having falls 2' to unsteady gait.  Tx with IVIG. Able to use walker and d/c for outpt f/u.					Y	6			Y	10/15/2008	10/16/2008	1	Labs and Diagnostics:  BUN 25.  Creatinine 1.4. LP with CSF protein 109.  CSF cs (-).  PFTs WNL. EMG abnormal.	PUB	UNK		None	PMH:  osteoarthritis.  Reflux. NKDA.			1						1	Asthenia; Guillain-Barre syndrome	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA366AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0332974	11/21/2008	MI	42.0	42		F	11/06/2008	Started with itchy eyes and persistent cough with phlegm production. Eyes became very red and puffy. Cheeks flushed; eyes and face puffy. Lips became swollen, chest red, warm and itching. later c/o headache, fever, chills and bodyaches. Took one generic Ibuprofen in evening. Treated swelling with ice chips. No reaction at injection sites reported. Did not seek medical treatment. RN encouraged MD follow up. Patient made appointment with MD 11/06/2008 per RN instructions									U	11/05/2008	11/05/2008	0		PUB	PUB	Water pill everyday	NONE	NKDA/HTN		M12008028	1						1	Chills; Cough; Erythema; Eye pruritus; Eye swelling; Flushing; Headache; Increased upper airway secretion; Lip swelling; Ocular hyperaemia; Pain; Pruritus; Pyrexia; Skin warm; Swelling face	FLU3~SANOFI PASTEUR~U2744AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2774AA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0332975	11/21/2008	MS	7.0	7		M	11/17/2008	Day after Flumist was given which was 11-5-08, child came home from school with red raised rash on top of foot. Next morning rash was on knees, back of thighs and stomach. Mom gave BENADRYL, went to immediate care was told was reaction to Flumist. Slowly cleared up after 3 days, did run low grade temp.									Y	11/04/2008	11/05/2008	1		PVT	PVT	SINGULAIR	None	Asthma- very mild. No active dx in 2 years.			1						1	Erythema; Pyrexia; Rash generalised	FLUN3~MEDIMMUNE VACCINES, INC.~500577P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0332977	11/21/2008	WA	11.0	11		M	11/11/2008	Mother stated child needed flu vaccine and was given prior to checking records. Child had FLUZONE given 10-8-08.									Y	11/11/2008				PVT	PUB						1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U2763AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332979	11/21/2008	MI	12.0	12		F	11/21/2008	Hives/rash at injection (L) site to shoulder and rash on (R) shoulder also. No SOB, abd pain or other symptoms. Patient given 50mg Benadryl PO phone call to mother. Patient rash resolved.				Y					Y	11/20/2008	11/20/2008	0		PVT	PVT	Concerta	NONE	NONE			1						1	Injection site urticaria; Rash	FLU3~SANOFI PASTEUR~U2810AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332980	11/21/2008	NM	3.0	3		F	11/20/2008	Henoch Schonlein Purpura 287.0. Abd pain around 11/10/2008. Purpura started around 11/10/2008. Seen 11/17/2008 and diagnosis made. Labs normal u/a normal 11/20/2008 rash fading.									Y	11/04/2008	11/10/2008	6	CBC; CRP; ESR; CMP; IgA; IgM; RF; UA NL; BP NL; 11/20/08, BP & U/S normal	PVT	PUB	None	None	None			1						1	Abdominal pain; Henoch-Schonlein purpura; Laboratory test normal; Urine analysis normal	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0332981	11/21/2008	MD	49.0	49		F	11/18/2008	Difficulty breathing (chest felt tight/ heavy) Coughing, hoarseness, Throat felt swollen. Eyes became extremely red and filled with pus. This occurred approx. 4 hours after FLUZONE. Treated by paramedics (given oxygen) taken to hospital ER.				Y					Y	11/06/2008	11/06/2008	0		OTH	OTH		None	None			1						1	Chest discomfort; Cough; Dysphonia; Dyspnoea; Eye discharge; Ocular hyperaemia; Pharyngeal oedema	FLU3~SANOFI PASTEUR~U2806AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332986	11/21/2008	MN	40.0			F	11/19/2008	Myalgias, profound  fatigue, muscle weakness (extremities), parasthesias, all suggestive of GUILLEAN BARRE. Creatine Kinase was also wildly elevated.				Y					Y				Creatine kinase = 387; (-) Lyme; ECR; B12	PVT	PVT		None	None			1						1	Blood creatine phosphokinase increased; Fatigue; Muscular weakness; Myalgia; Paraesthesia	FLU3~SANOFI PASTEUR~U2740AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332987	11/21/2008	FL	49.0	49		F	11/11/2008	8 x 10cm localized swelling, erythema, tenderness, pain onset 24hrs after				Y					Y	11/05/2008	11/07/2008	2		PVT	UNK						1						1	Erythema; Pain; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U2832AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0669X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0332988	11/21/2008	MO	5.0	5		M	11/21/2008	Red area (L) deltoid, somewhat tender. Motrin/ Tylenol PM.				Y					Y	11/14/2008	11/15/2008	1		PVT	PVT	None		None			1						1	Erythema; Tenderness	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC200163BB~7+~IM~LA~DTAP + IPV (KINRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500584P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~MERCK & CO. INC.~0931X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~07854~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0332989	11/21/2008	UT	2.0	2	.0	F	11/21/2008	Crying since flu shot was administered cranky, not wanting to walk much.				Y					Y	11/18/2008	11/18/2008	0		PVT	PUB		Ongoing OM/OE	Gastroesophageal reflux; Polycythemia			1						1	Crying; Irritability	FLU3~SANOFI PASTEUR~U2807AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB259AA~2~IM~RL~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0332990	11/21/2008	CA	16.0	16		F	11/19/2008	Teen received HPV #1 and MENACTRA on 10/29/08. + Urine pregnancy test on 11/4/08 (LMP 9/28/08). No treatment.									Y	10/29/2008			Urine Pregnancy test + 11/4/08	PUB	PUB	None	Eczema Rash	None			1						1	Drug exposure during pregnancy; Pregnancy test urine positive	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0650X~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2683AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0332991	11/21/2008	AL	11.0	11		M	11/20/2008	Local reaction with warmth, erythema and tenderness around injection sites of VARIVAX, ADACEL, and MENACTRA in both arms				Y					Y	11/17/2008	11/18/2008	1		PVT	PVT	None Known	None	None			1						1	Erythema; Feeling hot; Local reaction; Tenderness	FLUN3~MEDIMMUNE VACCINES, INC.~500567P~1~~~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~42637AA~1~~~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2998BA~UNK~IM~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1221X~2~~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0332993	11/21/2008	NY	5.0	5		M	11/21/2008	Sudden onset of hyporesponsivenes, went limp, jaw clenched shut, the episode lasted 5-10 minutes, followed by full recovery.				Y					Y	11/17/2008	11/18/2008	1	Head CT Negative; CBC and Chem 20 normal	PVT	PVT	None		None			1						1	Blood test; Computerised tomogram normal; Full blood count; Hypotonic-hyporesponsive episode; Joint stiffness	DTAP~SANOFI PASTEUR~300UAA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~V2855AB~4~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A1229~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1209X~2~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1018X~2~SC~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0332994	11/21/2008	OH	65.0	65		F	11/21/2008	Shot was administered in right arm on 11/11 about 3pm along with flu shot in left arm. Next day I went to work and had no symptoms, until about 8 pm I felt as if I had flu, called in sick and went to bed. Next day I had a temperature of 99.8 (my normal is 97.6), which lasted through 11/15, at one point peaking at about 100.8. My right arm at the injection site swelled until it was painful to touch (felt like a bee sting), I was unable to get out of bed, I had a slight headache, loss of appetite, mild confusion and forgetfulness and general feeling of illness. My husband called the medical facility on 11/13 and was told that I should ice intermittently and take ibuprofen, which I did. (I am allergic to salicylates, so I took only one 200mg ibuprofen/2xdaily.) It was quite painful to ice my arm. On 11/14 my husband drove me to the clinic to see the doctor at 5p; I was unable to sit up, my arm was swelling even more with fluid moving toward my elbow from the injection site high on my arm. Dr. thought it might be serum sickness and gave me a prescription for prednisone and betamethasone in lotion. I suggested taking antihistamines, which she agreed with. We were unable to fill the prescription until 11/15, but I was not interested in taking prednisone, as I had previously taken it before my food allergies were diagnosed, and suffered strong reactions, including hyperactivity and aggressive behavior. I did apply the lotion 2x daily as directed. The swelling ceased growing, but redness and diminishing swelling have persisted until 11/21. Currently there is a swollen lump at the injection site, which is tender and red. I was able to get out of bed on 11/16 and resume some activity, appetite had returned but arm was impossible to touch and raising it above my head or moving it was very painful. I went to work on 11/17, but was slightly confused and disoriented throughout the day (forgot to put on my hat to go home), and my arm was quite sore from using my computer throughout the day. I still feel slightly lethargic, but can now use my arm almost normally. In 1999 I had a previous pneumonia shot, which I do not recall having created a noticeable reaction, certainly nothing like my current experience. I was sensitive to typhoid shots as a child, and avoid penicillin because my brother had a severe allergic reaction (lost his hair) when inoculated. I am allergic to all dairy products and to salicylates, both synthetic and naturally occurring. I break out in hives/skin rashes from cumulative doses and have ringing in my ears. I now take salicylates only in very small doses for short periods. I am unable to tolerate most prescription pills because almost all contain small amounts of lactose (and possibly other compounds) which lead to my skin breaking out. I do wish prescription medications could be made without common allergens, dyes, etc. as it has been incredibly difficult to find those I can tolerate. It occurred to me that my adverse reaction to the pneumonia vaccine could be caused/compounded by additives to the vaccine itself, as my reaction in some aspects reminds me of the most severe stages of my food allergies, especially the lethargy, the formation of what I think are called purpura, and loss of appetite. I do not know the name of the manufacturer of the vaccines.				Y					Y	11/11/2008	11/12/2008	1		UNK	UNK			dairy, salicylates	penicillin~ ()~~0.00~Sibling		1						1	Activities of daily living impaired; Anorexia; Body temperature increased; Confusional state; Headache; Influenza like illness; Injection site erythema; Injection site mass; Injection site pain; Injection site swelling; Lethargy; Malaise; Memory impairment; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~UN~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0332996	11/21/2008	NH	1.17	1	.2	F	11/21/2008	Unknown at this reporting. Waiting for patient's parents to call back office to notify them of the incident. No report thus far of any adverse effects of the early IPV dose.									U	11/12/2008				PVT	PUB			1/14/2008 hospitalized for RSV bronchiolitis resolved without known complications.			1						1	Inappropriate schedule of drug administration	DTAPIPVHIB~SANOFI PASTEUR~C2900AA~4~IM~RL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~UT2792DA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332999	11/21/2008	MI	63.0	63		F	11/21/2008	PATIENT RECEIVED INFLUENZA AND TDAP ON SAME DAY. DEVELOPED CHILLS AND MYLAGIAS THAT NIGHT-RESOLVED BY NEXT AM.  FOLLOWING AM PATIENT DEVELOPED CONFLUENT ASYMTOMATIC RED RASH THAT BLANCHED WITH PRESSURE AROUND HER NECK,ON HER SHOULDERS AND DOWN THE MIDDLE OF HER BACK OVER THE SPINOUS PROCESSES.									U	11/17/2008	11/17/2008	0		UNK	UNK	ACTONEL,ZOLOFT,EVISTA,MOTRIN	NONE	PCN ALLERGY,OSTEOPOROSIS			1						1	Chills; Myalgia; Rash erythematous	FLU3~SANOFI PASTEUR~U2762AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C3030AA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0333002	11/21/2008	FL	46.0	46		F	11/21/2008	Fluzone 0.5ml injection given IM in deltoid of prominant arm at 1600 on 11/13/2008 at the infection control department of hospital(where she works in ER as a Physicians Associate).At 1730 pain in throat(near vocal cords) was noted and 15-20 mins thereafter recurrent dry cough,continued pain from throat inflammation,difficulty breathing,sob,chest tightness and wheezing.Albuterol/Atrovent updraft treatment given and po Claritin and Prednisone also given.At 1830 extreme itching/burning of eyes noted with redness and swelling of eyelids.Purulent yellowish, green discharge from eyes also occured.Benadryl 25mg IM x1 dose given at 2000 while in hospital and then 25mg po x1 dose taken at 2030 at home.By 2130 the breathing,itching & swelling of eyelids was much better with eyes being just a little irritated,slightly red.At 10pm when retiring to bed only a headache was noted.The next day at around 3pm at work extreme nasal congestion and scratchy throat noted which worsened over the next few days until 11/20/2008 when feeling much better.ADR was reported on 11/14/2008 to infection control at hospital.Prior history of recieving yearly flu shot without ill effects until this year.She was advised against recieving flu shot in future due to this ADR-she agreed to this.									Y	11/13/2008	11/13/2008	0	None	PVT	UNK	Flonase nasal spray.She had a  cold which started about 2 weeks prior to the ADR and had already completed antibiotic courses of Septra/Doxycycline for this.	None.	NKA. No medical conditions. Non-smoker.			1						1	Chest discomfort; Cough; Dyspnoea; Eye discharge; Eye irritation; Eye pruritus; Eyelid oedema; Headache; Nasal congestion; Ocular hyperaemia; Throat irritation; Wheezing; Bronchospasm; Chest discomfort; Cough; Dyspnoea; Eye discharge; Eye pruritus; Ocular hyperaemia; Oropharyngeal pain; Rhinorrhoea; Vision blurred; Wheezing	FLU3~SANOFI PASTEUR~U2764AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2764A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0333003	11/21/2008	VA	45.0	45		M	11/21/2008	Received flu shot on Wednesday Morning(11/19/2008), by early afternoon, developed muscle and joint aches, fatigue, headache, chills and low level fever. Took the following day off to rest.  Today feeling much better.									Y	11/19/2008	11/19/2008	0	None	PVT	UNK	Cozaar, Maxzide, Prozac, Actos, Singular, Protonix, Zyrtec, Flomax, Zocor, Topical Steriod Creams for psoriasis, Multi-vitamins.	None	Hypertension, High Cholestoral, Meniere's disease, sleep apnea, BPH, psoriasis, psoriasitic arthritis, GERD.			1						1	Arthralgia; Chills; Fatigue; Headache; Myalgia; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0333004	11/21/2008	NY	25.0	25		F	11/21/2008	Vaccine given at 1110 Am, at approx 4PM pt. began experiencing swelling of the lips and then the eyes with reddness and watering of eyes.  Took cetirizine at 10 PM with some relief but lips remain swollen and eyes red.									U	11/20/2008	11/20/2008	0	NONE	UNK	PVT	NONE	NONE	NONE			1						1	Eye swelling; Lacrimation increased; Lip swelling; Ocular hyperaemia	FLU3~SANOFI PASTEUR~u2800fa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333005	11/21/2008	IL	53.0	53		F	11/21/2008	Afternoon of 11/18/08 patient developed fatigue, all-over body aches, diarrhea and rash that covered arms, hands and back.  By 11/21/08 when patient notified health dept., patient reports rash going away and no other symptoms.  Patient reports having taken Benedryl. Patient did not contact doctor.  Advised patient to notify doctor of symptoms, and to seek medical treatment if symptoms worsen or if patient develops wheezing, facial swelling or difficulty breathing.									Y	11/17/2008	11/18/2008	1		PUB	PVT		patient denies	allergy to sulfa and ASA			1						1	Diarrhoea; Fatigue; Pain; Rash; Rash generalised	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~90000~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333008	11/21/2008	MN	43.0	43		M	11/21/2008	Patient presented to clinic on 11-17-08 with complaint of left shoulder and arm pain.  States he received a flu shot 11-6-08 and pain began within a few hours of receiving flu shot.  States the pain did not go away and has worsened each day, now extends down lateral arm halfway to elbow.  Patient pointed to spot just below left acromium process and states this is where his pain is and states this is where injection was given.  No redness or needle mark was noted. Chart indicates vaccine given IM in the left deltoid. Evaluation is ongoing as to cause/nature of problem.				Y					U	11/06/2008	11/06/2008	0	CBC, Sed Rate and MRI have been done so far.	PVT	PVT	Niacin and Lipitor	None.	Hypercholesterolemia.			1						1	Full blood count; Injection site pain; Laboratory test; Musculoskeletal pain; Nuclear magnetic resonance imaging; Pain in extremity; Red blood cell sedimentation rate	FLU3~SANOFI PASTEUR~U28099AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333009	11/21/2008	NE	57.0	57		F	11/21/2008	3 days after vaccine administer, developed headache, sore throat, rhinitis, tinnitis.  Tinnitis persisted 2 weeks later; audiogram documents diminished hearing as compared to 2006 testing.									U	11/06/2008	11/09/2008	3	Audiogram	UNK	UNK	Allegra D, Synthroid, Pre-pro, Aleve					1						1	Audiogram abnormal; Headache; Hypoacusis; Oropharyngeal pain; Rhinitis; Tinnitus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA365AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0333010	11/21/2008	SD	3.0	3		F	11/21/2008	Child recieved flu vaccine at 1357 on 111908 per Left deltoid IM.  Mom called CHS office back approximately 45 minutes later indicating the child was crying hard and was unconsoleable, complaining of severe arm pain, and wouldn't move arm.  Mom couldn't see any redness at injection site. RN advised Mom to take child to see her Dr.   Mom had administered 2 doses of Tylenol, prior to calling Community Health Services Office.   Mom took child to see PA at the Clinic and child was diagnosis with a sinus infection and was given antibiotics.   Note Mom reports that she had recieved a flu shot a couple of days ago and experienced tightness in her chest after being given the shot.  RN advised Mom to discuss this with the Dr. and Dr advised the flu be given in Dr's office next year.  Dad of this child also experienced a very stiff sore arm after recieving the flu shot this year.				Y					Y	11/19/2008	11/19/2008	0		UNK	UNK		Mom indicated no illness at time of injection.				1						1	Crying; Injected limb mobility decreased; Injection site pain; Sinusitis	FLU3~SANOFI PASTEUR~U2831AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333011	11/21/2008	IL	8.0	8		M	11/21/2008	Pt. received Hep. A, varivax, flu shot on 11/18/08.  He complaned of sore, scratchy throat 24 hours after vaccines, on 2nd day had hives all over body.  Still has hives on third day.  Benedryl given as ordered by Dr. office.									U	11/18/2008	11/19/2008	1		PVT	PVT	Trileptal 5 cc BID	none	Seizure disorder	fever~Mumps + Rubella (Foreign)~1~0.50~In Patient|fever~Measles + Mumps + Rubella (no brand name)~1~0.50~In Sibling1		1						1	Oropharyngeal pain; Throat irritation; Urticaria	FLUX~UNKNOWN MANUFACTURER~~3~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~1~IM~LL~HEP A (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~2~IM~RL~VARICELLA (NO BRAND NAME)~1	USA		Influenza
0333015	11/21/2008	NV	3.0	3		M	11/21/2008	Patient returned to office with history of sore throat, fever (102), red cheeks, and fine macular rash all over body.									N	11/19/2008	11/20/2008	1	Throat swab submitted.	PVT	PVT	None.	No.  This was a well check.	None.			1						1	Culture throat; Erythema; Oropharyngeal pain; Pyrexia; Rash generalised; Rash macular	FLUN3~MEDIMMUNE VACCINES, INC.~5005659P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0333019	11/21/2008	MN	5.0	5		F	11/21/2008	About 15 minutes after receipt of immunizations, pt developed swelling and rash of eyes, face, lips. Rash on trunk of body. General sense of I don't feel good.				Y					Y	11/06/2008	11/06/2008	0	Blood allergy testing for egg negative.	PVT	PUB	Allegra, albuterol PRN, Pulmicort or QVAR BID	None	Asthma, environmental allergies. No known food allergies.			1						1	Allergy test negative; Malaise; Rash; Swelling	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~ac20b084bb~5~IM~LL~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~u2803aa~4~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0664x~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1007x~2~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0333020	11/21/2008	CA	6.0	6		F	11/21/2008	6cm X 9cm redness and swelling and warm to touch									Y	11/19/2008	11/20/2008	1	none	PVT	PVT		No Known Illness	none			1						1	Erythema; Skin warm; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~U2849AC~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333023	11/21/2008	CA	8.0	8		F	11/21/2008	pt developed lobal pneumonia.  Became ill with fever the day following flumist administration.  Significant pneumonia.  Pt DOES have a history of wheezing w/respiratory infections (not disclosed by parent at time of immunization)				Y					Y	11/07/2008	11/08/2008	1	2 chest xrays, 3 courses of antibiotic (amox, omnicef, zithromax).  Pediatrics ID involved due to longer course of illness, but pt did not get hospitalized.  Administered by school nurse, supplied via public health dept, they have asked me to file report but I do not have all information.  Their phone# above, if needed.	UNK	PUB	none	none	mild seasonal reactive airways disease			1						1	Chest X-ray; Lobar pneumonia; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500560P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0333024	11/21/2008	IL	35.0	35		F	11/21/2008	Patient said injection site is warm to touch, painful, swollen and red..seemed to be spreading down arm toward elbow.  Also had night sweats for 2 nights so far that required 4x pajama change and a fever of 101.3 Thursday night 11/20/08.  Reported slight shortness of breath when climbing stairs. She said she was ignoring symptoms and hoping that it wasn't really happening...that is why she didn't call until Friday at 3:45pm 11/21/08.				Y					N	11/18/2008	11/19/2008	1		UNK	PVT		None Reported when interviewed	None Reported on interview. Came in specifically for pneumonia and flu shots			1						1	Dyspnoea; Erythema; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Night sweats; Pyrexia	FLU3~SANOFI PASTEUR~u2849ac~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0867x~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0333034	11/21/2008	WA	1.1	1	.1	F	11/21/2008	Seizure approx. 10 hours after vaccination. Patient remains hospitalized. 11/25/08 MR received for 11/19-21/2008 with DX: Seizure. On the evening of 12 mon vax pt was noted to be staring off into space. R arm began shaking then progressed to R leg and whole body shaking. Lasted 7-10 min.  Difficult to awaken afterward. Temp 99.9'F. Sleepy in ER, otherwise exam WNL.					Y	2			Y	11/19/2008	11/19/2008	0	Labs and Diagnostics: Head CT normal. Venous blood gas-mildly acidotic. CXR WNL. blood cx (-). CBC with WBC 9.3-60.2% neutrophils.	PVT	PUB			Cardiac murmur; breast hypertrophy; eczema. PMH: Febrile sz 3 weeks ago. Heart murmur. Fam hx of seizure			1						1	Convulsion	FLU3~SANOFI PASTEUR~UT2786GA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB524AA~3~IM~LL~HEP B (ENGERIX-B)~1|MMR~MERCK & CO. INC.~0891X~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C22253~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0333036	11/21/2008	WA	59.0	59		M	11/18/2008	11-01-08 Hot red spot 2 with improvement. 11-06-08 NP attempted with success IV antibiotics; sent to doctor/orthopedic doctor then admit to hospital (11-06 - 11-13). Surgery/sterile abscess. Currently wound care and antibiotics. 12/2/08 Reviewed hospital medical records of 11/6-11/11/2008. FINAL DX: left deltoid abscess after pneumovax, s/p I&D. Records reveal patient experienced injection site swelling, erythema, induration & decreased mobility of left arm where he received pneumovax. Seen in clinic & sent to surgeon for aspiration of area.  Admitted for I&D, IV antibiotics.  D/C to home on continued oral antibiotics, insulin & wound clinic f/u for wound vacuum treatment.					Y	6			Y	10/31/2008	11/01/2008	1	In patient testing. GRAM Stain Final, moderate to many polys, many RBCS, no organism seen, 11/07/08 - 1136; ANAEROBE Culture Final, no anaerobes isolated in 5 days, 11/11/08-0816; GRAM Stain Final, test not performed, 11/07/08-1136; Wound Culture Final, see anaerobe culture for Gram Stain, no growth after 2 days, 11/08/08-1221 LABS: wound & blood c/s neg.	PUB	UNK		No illness	Diabetes - (L) shoulder has metal prosthesis since 2003  PMH: Type 2 DM, CAD, CHF, EF 30%, HTN, hyperlipidemia, paroxysmal atrial fib, anemia secondary to chronic disease, chronic renal failure, hypocalcemia, hyperphosphatemia, obesity, PVD w/bilateral LE amputations, malnutrition, hyperuricemia.  Allergy: PCN, hives.			1						1	Abscess; Gram stain negative; Surgery	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA15BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0989U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0333037	11/21/2008	IL	7.0	7		F	11/20/2008	Was given FLUMIST on 11/14 afternoon then few hours later developed fever and vomiting then chest pain diagnosed with left lower lobe pneumonia. Admitted to hospital as out patient for IV fluids. Placed on two antibiotics and pain relievers.  12/5/08 Reviewed ER medical records of 11/17/2008. FINAL DX: vomiting & dehydration; pneumonia Records reveal patient experienced nausea, vomiting, dehydration, dry mouth, sunken eyes, veins flat.  IV had to be started w/difficulty by anesthesia.  Tx w/IVF, antipyretics. Follow-up: This is to update a VAERS report that we submitted for this patient. The VAERS ID # is 333037. Pt was seen in our office on 11/26 for follow up on her pneumonia. She had a repeat chest Xray done at that time that revealed her pneumonia was worse and had progressed into the left upper lung as well as lower. She was admitted into hospital. Cat scan was completed at hospital which revealed the left lung had collapsed and pleural effusion had worsened. Pt was placed on ICU status and on Friday 11/28 had surgery to place two chest tubes in left side and debridement of the pleural cavity. Patient remained in ICU for 5 days. Given IV Vancomycin and Cefotaxime while admitted. Was released home from hospital on 12/4 and continues IV Cefotaxime every 8 hours via home infusion for at least one more week. Will be reevaluated for further IV antibiotics by Dr. in one week. Thank you for your attention in this matter.				Y					Y	11/14/2008	11/14/2008	0	Urine culture negative, Throat culture negative  LABS: Urine, throat c/s neg.  CXR revealed large left pleural effusion w/consolidation c/w pneumonia.	PVT	PVT	None	None	None			1						1	Chest pain; Chest tube insertion; Collapse of lung; Computerised tomogram abnormal; Culture throat negative; Culture urine negative; Debridement; Intensive care; Lobar pneumonia; Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500541P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0333038	11/21/2008	OH	1.3	1	.3	M	11/05/2008	Swollen left thigh with slight drainage. Unable to walk for 5 days.									Y	11/04/2008	11/04/2008	0		PUB	PUB	ZANTAC, PULMACORT, CLARINEX, SINGULAIR, ALBUTEROL	No	Asthma; ? food allergy			1						1	Abasia; Injection site extravasation; Injection site swelling	DTAPIPVHIB~SANOFI PASTEUR~C3201AA~1~IM~LL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~UT2788HA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C73446~4~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0333040	11/21/2008	MA	68.0	68		F	11/19/2008	After rec. vaccine at 11:35am, extreme fatigue noted from approx 1:00pm- 9:00pm. At approx 4:30-6:00pm area around left eye a small flashing eura with color outside which did effect vision slightly. Stopped approx 6:00pm.									Y	11/18/2008	11/18/2008	0		UNK	OTH	LEVOTHYROXINE 50mcg, ZETIA 10mg, ZOLOFT 25-50, ATENOLOL 12.5mg		HAYFEVER, MUGWORT, TREES, ETC.			1						1	Aura; Fatigue	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89968~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333041	11/21/2008	AK	63.0	63		F	10/29/2008	Local swelling & inflammation in entire left shoulder area. Ice & Tylenol.									Y	10/17/2008	10/17/2008	0		PUB	PUB		None	None			1						1	Inflammation; Local swelling	FLU3~SANOFI PASTEUR~U2829AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1383U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0333042	11/21/2008	AZ	10.0	10		M	11/21/2008	After received flu vaccine, it leaked out a little & next day swollen red sore arm.									Y	11/18/2008	11/19/2008	1	None	PVT	PVT	None	None	None			1						1	Erythema; Injection site extravasation; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U2767AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333043	11/21/2008	WY	49.0	49		F	11/12/2008	Pt called the store and reported that she was having allergic reaction including hives, diarrhea, possible swelling in the throat and some difficulty breathing. Pharmacist on duty advised her to go to the ER. Pt did go to walk in clinic but by the and she was seen, symptoms were gone and no treatment was needed or given.				Y					Y	11/06/2008	11/06/2008	0	Symptoms had subsided by the time she was seen by MD so no medication was given. MD recommended Benadryl at home but patient didn't need it.	OTH	PVT			Food allergy to sage			1						1	Diarrhoea; Dyspnoea; Hypersensitivity; Pharyngeal oedema; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0333044	11/21/2008	WA	4.0	4		M	11/21/2008	Gave flu shot in left deltoid and child had local reaction to injection. Swelling was 2 from point of entry and redness 9 toward elbow from point of entry. 1 ml PO of Benadryl given and father was instructed to ice and give Tylenol if needed. Discussed with MD. Patient is to return to clinic if symptoms worsen.									Y	11/21/2008	11/21/2008	0		PUB	UNK						1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2806AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333046	11/21/2008	MN	49.0	49		F		Within one day patient has extreme muscle weakness and pain both legs and back and lasted > 1 week. CK up. ESR up.				Y						11/14/2008	11/15/2008	1		PVT	UNK		No	Chronic lower back pain, HTN			1						1	Back pain; Muscular weakness; Pain in extremity	FLU3~SANOFI PASTEUR~U2772AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333047	11/21/2008	MD	54.0	54		F	11/18/2008	< 48 hr after vaccine pt developed intense pruritis and multiple discrete red papules over trunk & extremity.  No relief with BENADRYL.  PREDNISOLONE given.				Y					Y	11/13/2008	11/14/2008	1	None	PVT	UNK			Anaphylactic rxn to CELEBREX- 2003  PCN-codeine- Celebrex-Erythromycin			1						1	Erythema; Pruritus; Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89617~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0333048	11/21/2008	NH	63.0	63		F	11/21/2008	Pt reported that 12 hours after receiving vaccines she started with fever HA, vomiting, diarrhea, and swelling and pain at the injection site. Unable to keep solid down. Sx continue today at OV on 11/21/08, but afebrile.									U	11/18/2008	11/19/2008	1		PVT	PUB	Gluxotrol; HCTZ; Zocor; ASA; Enalaprl; Mctoclopramide					1						1	Diarrhoea; Headache; Injection site pain; Injection site swelling; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2745AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0619X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0333049	11/21/2008	TX	18.0	18		F		3:15 pm injection. Five minutes later reported blurred vision and feeling strange. Had patient sit down, reported feeling warm and nauseous. She asked for some water, gave a bottle, drank a little but did not feel any better. Did not have breathing difficulty or swallowing. 3:30 pm reported that she was having hearing difficulty.				Y					Y	11/21/2008	11/21/2008	0	Not available	UNK	UNK		None mentioned				1						1	Feeling abnormal; Feeling hot; Hypoacusis; Immediate post-injection reaction; Nausea; Vision blurred; Blindness transient; Feeling abnormal; Feeling hot; Hearing impaired; Nausea; Vision blurred	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881131P~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881131P~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0333050	11/21/2008	KY	49.0			M		Felt bad and swollen neck, glands PSI about 24 hours.									Y					OTH	PVT		sore throat				1						1	Feeling abnormal; Local swelling; Lymphadenopathy	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~878T13P~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333051	11/21/2008	NJ	25.0	25		M	11/21/2008	Swelling and redness of upper extremity.									N	11/18/2008	11/20/2008	2	Clinical exam	PVT	UNK	None	NONE	NKDA, none			1						1	Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~U2745AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2998BA~1~UN~RA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~0330X~1~UN~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0333053	11/21/2008	CA	54.0	54		M	11/21/2008	Fever following vaccine administration sweats, chills, aches. Pain at site and constipation.									Y	11/17/2008	11/20/2008	3		PVT	OTH		Chronic dzs only	Asthma, Allergies, HTN, IFG	Similar~Influenza (Seasonal) (no brand name)~UN~0.00~In Patient		1						1	Chills; Constipation; Hyperhidrosis; Injection site pain; Oedema; Pyrexia	FLU3~SANOFI PASTEUR~U2767AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0867X~1~UN~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2825AA~1~UN~RA~TDAP (ADACEL)~1	USA		Influenza
0333055	11/21/2008	AZ	46.0	46		F	11/20/2008	Received flu shot 10/24/08 in R arm. No discomfort until soreness began on the underside of upper and lower R arm 10/27/08. Soreness has been intermittent but still persists.				Y					U	10/24/2008	10/27/2008	3		OTH	PVT	None	None	None			1						1	Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA367EA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0333057	11/21/2008	TX	56.0	56		M	11/21/2008	Fever to 101 degrees, chills, headache, swelling, pain, warmth & redness to injection site in left arm.									Y	11/17/2008	11/18/2008	1		PVT	PVT	None	None	Allergies=penicillin			1						1	Chills; Feeling hot; Headache; Injection site erythema; Injection site swelling; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U2739AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0867X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0328609	11/24/2008	KS	69.0	69		F	11/21/2008	Initial and follow-up information has been received from a registered nurse concerning a 69 year old female with no known drug allergy and high cholesterol and a history of angioplasty with LAD coronary artery stent and dementia who on 13-OCT-2008 at 3:00 p.m., was vaccinated with PNEUMOVAX, Lot # 662354/0814X, 0.5 ml, intramuscularly into her right arm and FLUZONE, Lot # U2761AA, intramuscularly into her left arm.  Other concomitant therapy included CRESTOR and PLAVIX.  It was reported by the registered nurse that the patient on 13-OCT-2008, within 6 hours of injection (also reported as 6:00 p.m.), the patient complained of severe pain at upper right arm from the shoulder to the elbow.  At 3:00 a.m. the patient went to emergency room with complaint of 10/10 pain at right arm.  No redness or edema.  On 14-OCT-2008, the patient was admitted on observation from 3:00 - 9:30 a.m. of an unspecified hospital for treatment of the arm pain.  No specific emergency room treatment was reported other than the patient was given one LORTAB for pain and blood was also drawn, reported within normal limits.  The patient was discharged.  On 14-OCT-2008, by 4:00 p.m., the patient's husband reported that she was resting with only a soreness at right arm.  No other symptoms or treatment reported.  On 14-OCT-2008, the patient recovered.  No further information is available.				Y	Y	0			Y	10/13/2008	10/13/2008	0	Diagnostic laboratory, 10/14/08, within normal limits	PUB	PUB	PLAVIX; CRESTOR	Cholesterol high	Angioplasty; Dementia; Coronary artery surgery		WAES0810USA02724	1						2	Injection site pain; Laboratory test normal; Pain in extremity; Laboratory test normal; Pain in extremity	FLU3~SANOFI PASTEUR~U2761AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0814X~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U2761AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0814X~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0331936	11/24/2008	MD	3.0	3		M	11/20/2008	Initial report received on 14 November 2008 from the patient's parent. A three-year-old male patient, who had no concurrent illnesses, no known allergies, and no past medical history, had received a first dose of FLUZONE SV 2008-2009 on 29 October 2008. The lot number, route and site of administration were not provided. Per the reporter, three days post-vaccination, the patient developed a nose bleed and was evaluated by a physician and diagnosed with idiopathic thrombocytopenia that day. Relevant diagnostic tests included platelet count that was 187,000 on 29 October 2008, and had fallen to a very low count on 01 November 2008. It was not reported whether the patient had received any corrective treatment, or if he required any hospitalization. The recovery status of the patient was not reported. Documents held by sender: None				Y					U	10/29/2008	11/01/2008	3	Platelet count that was 187,000 on 29 October 2008, and had fallen to a very low count on 01 November 2008.	UNK	UNK			The patient had no concurrent illnesses at the time of the vaccination on 29 October 2008. He has no known allergies and no past medical history, or use of other medications. The patient did not receive any other vaccinations within four weeks of 29 October 2008. A platelet count on 29 October 2008 was 187,000.		200803624	1						2	Biopsy bone marrow; Blood blister; Blood product transfusion; Epistaxis; Gingival bleeding; Idiopathic thrombocytopenic purpura; Petechiae; Platelet count decreased; Purpura; Epistaxis; Idiopathic thrombocytopenic purpura; Platelet count decreased	FLU3~SANOFI PASTEUR~U2804AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0333031	11/24/2008	NJ	2.0	2	.0	F	11/24/2008	Patient appeared to be unable to see during the night two days after receiving the vaccine. She seemed to grope for her mother without seeing her. In the morning, she asked, What happened to eyes? She also had fever and cold symptoms for two days.									Y	10/16/2008	10/18/2008	2	We called her pediatrician's office, and a doctor  said there was nothing to worry about, so she was never seen by a doctor or tested despite our concerns. We were referred to a neurologist by our pediatrician, but that doctor wasn't available until mid January.	UNK	UNK		none	none			1						1	Nasopharyngitis; Pyrexia; Visual acuity reduced	FLU3~SANOFI PASTEUR~U2802AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333056	11/24/2008	NJ	1.03	1	.0	M	11/21/2008	Fever started on 11/16/08 101-104 Degrees axt. Rash chest/diaper area. Increased irritability & crankiness.									Y	11/10/2008	11/17/2008	7	None	PVT	UNK		None	None			1						1	Irritability; Pyrexia; Rash	FLU3~SANOFI PASTEUR~UT2794DA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1250X~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0512X~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0333060	11/24/2008	MD	14.0	14		M	11/18/2008	Drive thru flu clinic - 14 y/o child received adult formulation. No phone number provided, mailed letter to notify.									U	11/15/2008				OTH	OTH	Unknown		Unknown			1						1	Incorrect dose administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA209AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0333061	11/24/2008	MD	8.0	8		M	11/18/2008	Drive thru flu clinic, 8 year old child received adult formulation. No phone number provided, mailed letter for patient to call our office to notify.										11/15/2008				OTH	OTH			Unknown			1						1	Inappropriate schedule of drug administration; Incorrect dose administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA209AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0333062	11/24/2008	MD	14.0	14		M	11/18/2008	Drive thru flu clinic -14 y/o child received adult formulation.  No phone number provided.  Mailed letter to pt to call our office to notify										11/15/2008				OTH	OTH	Unknown	Unknown	Unknown			1						1	Inappropriate schedule of drug administration; Incorrect dose administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA209AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0333063	11/24/2008	WV	64.0			U		After 10-15 min, started having chest pains waited 30 ? min, got worse (I had to wait for my ride). Felt like severe indigestion or gallbladder attack which I never had before or since they took back, gave me 2 table spoons MALOX and oxygen, then (left weak kneed had a headache Saturday, slight headache).									Y					PUB	UNK	None	Hard to breathe, chest pains	None			1						1	Asthenia; Chest pain; Headache	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333064	11/24/2008	CT	31.0	31		F	11/19/2008	Two days following pneumonia immunization patient c/o vomiting fever, and reddened area at site of injection.  Seen by MD on 11-13-08 & diagnosed with cellulitis and treated with KEFLEX.				Y					Y	11/10/2008	11/12/2008	2		PUB	PVT		No	No			1						1	Cellulitis; Injection site erythema; Pyrexia; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881292P~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~05550~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0333068	11/24/2008	WI	15.0	15		F	11/18/2008	>60 seconds seizure. Stiff, unable to move, exhausted.									Y	11/10/2008	11/10/2008	0		PVT	PUB	None	None				1						1	Convulsion; Fatigue; Hypokinesia; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U29797BA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B087AA~1~IM~RA~TDAP (BOOSTRIX)~1	USA		Influenza
0333070	11/24/2008	WA	4.0	4		M	11/17/2008	(L) Upper arm red, swollen, itchy, low grade FVR yesterday, none today, still using arm/treated with cephalexin.									U	11/12/2008	11/12/2008	0		PVT	UNK		NML	None			1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Pyrexia	DTAP~SANOFI PASTEUR~C2955BA~5~UN~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2806AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A1060~4~UN~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0890X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0951X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0333071	11/24/2008	WI	82.0	82		F	11/18/2008	Hot, sweating, vomiting - diarrhea, chills, crushing pain, fever, dizzy, headache. It lasted three days. Very weak and dizzy for several days. Hoarseness.									Y	10/31/2008	10/31/2008	0	None	PVT	UNK	Antidiarrheal; aspirin 325 mg oral tablet, 1 TAB po daily; atenolol 100 mg oral tablet, 1 TAB po daily; bilberry 1000 mg daily; CENTRUM SILVER oral tablet, chewable (Multivitamin with minerals) 1 TAB chewed daily; chlorthalidone 25 mg oral	None	Piroxicam, codeine, DARVON, propoxyphene			1						1	Asthenia; Chills; Diarrhoea; Dizziness; Dysphonia; Feeling hot; Headache; Hyperhidrosis; Pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2755AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333073	11/24/2008	CA	1.2	1	.2	F	11/18/2008	14 month old female was healthy until recent vaccine 11/14/08 at 10:30 AM. They included flu (first time), DTP (4th dose) and PREVNAR (4th dose) im injection. Pt went home took a nap 3 pm and woke up with facial swelling, croupy cough, SOB. Pt brought to ER and given DECADRON AND BENADRYL									Y	11/04/2008			X-ray showed croup	OTH	OTH			Birth Hx: Probable methamphetamine exposure. Child adopted.			1						1	Cough; Croup infectious; Dyspnoea; Swelling face; X-ray abnormal	DTAP~GLAXOSMITHKLINE BIOLOGICALS~C99642~4~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~AC14B087BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~UT2782CA~4~IM~RA~PNEUMO (PREVNAR)~1	USA		Influenza
0333074	11/24/2008	PA	2.0	2	.1	F	11/20/2008	Vesicular eruption consistent with attenuated varicella vaccine.				Y					Y	10/29/2008	11/20/2008	22		PVT	UNK		No	Episodic otitis media/Bronchiolitis - not currently			1						1	Rash vesicular	DTAP~SANOFI PASTEUR~C2999AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2782EA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1138X~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0333076	11/24/2008	PA	37.0	37		F	11/04/2008	Received flu shot 10/31/08 at 13:18 hrs. Developed symptoms of throat swelling and difficulty breathing. Treated with ALBUTEROL Nebulizer 2.5 mg in 3 mlns, BENADRYL, 25 mg IVP.				Y					Y	10/31/2008	10/31/2008	0	EKG rhythm strip/pulse oximeter	PUB	PVT	Toprol 50 mg daily; ASA 325 mg daily	None	Valve replacement, Hypothyroidism, arrythmias. Allergies: IV dye; VICODIN; codeine, Iodine.	Hives/pruritus~Influenza (Seasonal) (no brand name)~UN~0.00~Patient		1						1	Dyspnoea; Electrocardiogram; Oxygen saturation; Pharyngeal oedema	FLU3~SANOFI PASTEUR~U2753AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333077	11/24/2008	OR	57.0	57		M	11/20/2008	Vaccine given around 5:30PM. Pt wife states, severe cough, tightening of throat by 8:30PM Benadryl taken Sx resolved.									Y	11/18/2008	11/18/2008	0		OTH	PVT	NONE KNOWN	NONE KNOWN	Hyosoyamine; egg allergy as child- undisclosed at time of vaccine.			1						1	Cough; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA168AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0333081	11/24/2008	HI	41.0	41		F	11/18/2008	Soreness and slight swelling under injection site (L) deltoid. Swelling and slight pain 2 inches above (L) wrist. Discomfort along (L) arm (descending from injection site to (L) wrist).									U	11/17/2008	11/17/2008	0	None	OTH	PUB	BCP	None	NKA		HI0806	1						1	Injection site pain; Injection site swelling; Limb discomfort; Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89983~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333097	11/24/2008		1.8			M	11/20/2008	This serious case was received from a health care professional on 17 November 2008. SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. A 22-month-old male patient received FLUZONE SV (lot number and date of administration not reported). Approximately 48 hours after vaccination, he developed Ketoacidosis, and was subsequently diagnosed with Type I diabetes mellitus. The reporter, a physician who was a friend of the patient's parent, did not have any additional information to provide. Of note, the reporter refused to provide contact information, but did agree to contact the patient's primary care physician directly to obtain additional information. Documents held by sender: None.				Y										OTH	UNK					200803627	1						1	Ketoacidosis; Type 1 diabetes mellitus	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333098	11/24/2008	NY	47.0	47		F	11/20/2008	Initial information was received on 17 November 2008 from a health care professional. A 47 year old female patient with allergies to penicillin, codeine, DEMEROL, iodine, and bee venom received an intramuscular right deltoid injection of FLUZONE SV 2008-2009 (lot number U2771AA) on 07 November 2008. Three hours post vaccination the patient experienced shortness of breath (SOB), swollen tongue and throat, headache and itching. The patient self treated with EPIPEN and BENADRYL 25 mg. The patient went to the ER and was treated with Prednisone, BENADRYL and a pain medication for her headache. The patient had an EKG completed (results not reported). The patient was recovered at the time of the report. List of Documents held by Sender: None.				Y					Y	11/07/2008	11/07/2008	0	None reported	UNK	UNK	CRESTOR		The patient had an allergy to penicillin, codeine, Demerol, iodine and bee venom.		200803654	1						1	Dyspnoea; Electrocardiogram; Headache; Pharyngeal oedema; Pruritus; Swollen tongue	FLU3~SANOFI PASTEUR~U2771A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333099	11/24/2008	KY				F	11/20/2008	Initial report was received 18 November 2008 from a health care professional.  A female patient (age and date of birth not reported) with an unknown medical history, had received a dose (administration, route and site not reported) of FLUZONE, lot number U2849AC on 07 November 2008 and an unspecified amount of time later, she developed a cardiac problem which required a stent.  The patient's recovery status was unknown and the reporter had no additional information to provide at the time of the report.  The reporter for this case is the same as case number 2008-03658.  Documents held by sender: None				Y					U	11/07/2008			Not reported	PVT	UNK			Unknown		200803659	1						1	Cardiac disorder; Stent placement	FLU3~SANOFI PASTEUR~U2849A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333100	11/24/2008	WA	23.0			F	11/20/2008	Initial report was received 18 November 2008 from a health care professional. A 23-year-old female patient with an unknown medical history, had received a first dose intramuscular right deltoid injection of FLUZONE SV 2008-2009, lot number U2749AA and a right deltoid injection (route not reported) of PNEUMOVAX (manufacturer and lot number not reported), on 10 November 2008 and approximately eight hours later, she developed a right deltoid abscess. The patient was hospitalized for two days (dates not reported) and she received corrective treatments with antibiotics (names and routes of administration not reported) and the abscess was drained. The reporter stated the patient's parent called them to report this event. At the time of the report, the patient had not recovered from the event and no further information was provided. Documents held by sender: None					Y	2			N	11/10/2008				PVT	UNK			The patient had no known allergies. It was unknown if the patient had any concurrent illnesses or pre-existing medical conditions, and if they had been taking any concomitant medications.		200803661	1						1	Abscess drainage; Injection site abscess	FLU3~SANOFI PASTEUR~U2749A~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0333103	11/24/2008	PA	25.0	25		M	11/01/2008	Nausea, vomiting, temp 105 to E.R. & admitted to hospital - Cellulitis of arm, vomiting, jaundice.   12/29/08 MR received for DOS 11/21-24/2008 with d/C DX:  Cellulitis.  Increased liver functions.  Hx of hereditary spherocytosis. Pt presented with c/o chills, rigors, nausea, vomiting and arm pain. PE (+) for fever, dry mucous membranes, scleral icterus, and tnderness, erythema and warmth of the R upper arm.  Tx with abx. Increased LFTs likely 2' to hereditary spherocytosis. Slow improvement in pain and swelling so abx were changed and effective.					Y	3			U	10/20/2008	10/20/2008	0	Labs, IV's, Antibiotics. Labs and Diagnostics:  Total bili 2.5.  ALT 66-93.  AST 37-43. Alk phos 218 WBCs 20.1. Flu (-). Hep A, B and C (-).	PVT	UNK	None	No	Hx of splenectomy. PMH: cold sores. hereditary spherocytosis with splenectomy			1						1	Body temperature increased; Cellulitis; Jaundice; Laboratory test; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U2802AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0870X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0333104	11/24/2008	AZ	39.0	39		M	10/29/2008	Pt noted chest/asthma like Sx. increase PND, slight cough and itchy throat. Pt takes q o wk allergy injections.									Y	10/29/2008	10/29/2008	0	None	OTH	PVT	Nasonex; Claritin; Albuterol inhaler prn.	None	Asthma; Allergies (seasonal)			1						1	Asthma; Cough; Postnasal drip; Throat irritation	FLU3~SANOFI PASTEUR~U2740AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333105	11/24/2008	MI	58.0	58		F	11/04/2008	Approx 3 hours after injection starting clearing throat action where it seemed to be a constant clearing of throat with irritation.  Medicine taken and within 3 minutes started to note some relief - it continued on thru afternoon but no increase of symptoms.  Started with chills and headache approximately around 3 PM - home at 4 PM, to bed - forcing fluids - ASA and Motrin.  Better in AM - only c/o headache.									Y	11/03/2008	11/03/2008	0		PVT	PVT	Premarin	None	None			1						1	Chills; Headache; Throat irritation	FLU3~SANOFI PASTEUR~U2762AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333107	11/24/2008	NY	11.0	11		F	11/30/2008	Redness and swelling left arm at injection site.  Advised to apply cool compress and Tylenol PRN.									U	11/12/2008	11/13/2008	1	None	PVT	PVT		None	None			1						1	Injection site erythema; Injection site swelling	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB259AA~2~IM~RA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2731AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0333110	11/24/2008	NY	1.6	1	.6	F	11/20/2008	After given 2nd dose of flu vaccine - patient sustained fever and vomiting.  Advised by doc more than likely exposed to illness in office, not vaccine reaction - but will file.									U	10/27/2008	10/29/2008	2	None	PVT	PVT	None	None	None			1						1	Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~UT2787AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333111	11/24/2008	FL	1.5	1	.5	M	11/21/2008	Vaccine given on 11/19/08, on 11/20/08 patient presents with urticaria all over body. No distress.									Y	11/19/2008	11/20/2008	1		PVT	PUB	Rondecidmen- 10/06/08	None (Had few loose BM few days ago)	Pulm-stenosis.			1						1	Urticaria	DTAP~SANOFI PASTEUR~C2933AB~4~UN~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT27979A~2~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB247AA~1~UN~LA~HEP A (HAVRIX)~1|HIBV~SANOFI PASTEUR~UF495AB~5~UN~LA~HIB (ACTHIB)~1	USA		Influenza
0333113	11/24/2008	TX	51.0	51		F	11/23/2008	The patient states that she has had continued soreness and aching in the shoulder where she received the flu vaccine.									N	10/31/2008	10/31/2008	0		OTH	PVT						1						1	Musculoskeletal pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881131P~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333114	11/24/2008	NJ	53.0	53		F	11/19/2008	Employee developed ovoid mass approximately 7 cms in height an 3 cm in width across mid right clavicle. Received FLUZONE on 12 Nov 2008 at 3:10 P.M. here at work. She noted the swelling the evening of 12 Nov 2008 after throwing a baseball. Was seen by me on 14 Nov 2008 and worked up by the personal physician at				Y					U	11/12/2008	11/13/2008	1	Had MRI with dye, chest xray, leading to the conclusion of an infected lymph node.	OTH	PVT						1						1	Chest X-ray abnormal; Mass; Nuclear magnetic resonance imaging abnormal; Swelling	FLU3~SANOFI PASTEUR~Q2532AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333115	11/24/2008	NE	48.0	48		F	11/24/2008	Had shortness of breath and cough 3 hours after flu shot given, then chest pain for about for about an hour later that night.									Y	11/21/2008	11/21/2008	0		PUB	PVT						1						1	Chest pain; Cough; Dyspnoea	FLU3~CSL LIMITED~02649111A~UNK~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0333116	11/24/2008	TX	60.0	60		U	11/14/2008	Sore, itching red mark around needle point. started with the size of a quarter-spreaded all down the arm to maybe approx. 6 long and 3 wide. Very red and hurtful.				Y					N	11/05/2008	11/05/2008	0		OTH	UNK						1						1	Injection site erythema; Injection site pain; Injection site pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA208AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0333117	11/24/2008	MN	51.0	51		F		3 Hours after receiving FLUZONE vaccination, experienced sore throat generalized achiness, bad chills, burning, itching eyes, tongue and lips swelled, very painful tongue and lips; finger tips felt like they were burning. Sought medical attention on 11-05-08 started on Prednisone & Benadryl p.o. Able to return to work on 11-06-08. MD recommended no future flu shots.				Y					Y	11/04/2008	11/04/2008	0	Unknown	OTH	PVT	Synthroid p.o.	None	Hypothyroidism	~Influenza (Seasonal) (no brand name)~UN~49.00~In Patient		1						1	Burning sensation; Chills; Eye irritation; Eye pruritus; Glossodynia; Lip pain; Lip swelling; Oropharyngeal pain; Pain; Swollen tongue	FLU3~SANOFI PASTEUR~U2743AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333118	11/24/2008	PA	39.0	39		F	11/21/2008	Nausea, vomiting, temp 105 went to ER for labs, IV fluids, WBC increased 20.				Y					Y	10/29/2008	10/30/2008	1		PVT	UNK	None		None			1						1	Body temperature increased; Nausea; Vomiting; White blood cell count increased	FLU3~SANOFI PASTEUR~U2810AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~09914~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0333121	11/24/2008	IN	9.0	9		F	11/24/2008	Localized reaction. Injection site redder, inflamed c/o itching at site some tenderness (L) lot Prox OE, 9x10cm area with 5mm induration. Benadryl/Aytec for 5x5.									Y	11/20/2008	11/20/2008	0	None	PUB	PVT	Zyrtec	None	None			1						1	Injection site erythema; Injection site induration; Injection site inflammation; Injection site pain; Injection site pruritus; Local reaction	FLUN3~MEDIMMUNE VACCINES, INC.~500583P~5~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~1323X~2~SC~~VARICELLA (VARIVAX)~1	USA		Influenza
0333145	11/24/2008	MN	31.0	31		M	11/24/2008	None. Patient was inadvertently given DTaP instead of Tdap.									Y	11/13/2008			None	PVT	PVT		None	None			1						1	Wrong drug administered	DTAP~SANOFI PASTEUR~U2789AA~UNK~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2397AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333147	11/24/2008	CA	62.0			M		Wheezing, sore throat									Y				Physical exam	UNK	UNK		none	Asthma; CAD. H/O MI; hypothyroid; HTN; OA			1						1	Oropharyngeal pain; Physical examination; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA174AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0333152	11/24/2008	MI	60.0	60		F	11/24/2008	Headache intermittant for a week after.  Sore right arm (arm that received flu vaccine is the right).  Tdap went in the left arm.									Y	10/31/2008	10/31/2008	0		UNK	PUB			Fibromyalgia.  Allergy to PCN and Sulfa.			1						1	Headache; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3888AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|TDAP~SANOFI PASTEUR~C2689AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0333153	11/24/2008	VA	0.92	0	.9	M	11/24/2008	TURNED LIMP AND IRRITABLE X2 DAYS. NO CYANOSIS, NO SEIZURES,NO FEVER									Y	10/29/2008	10/29/2008	0	NONE	PVT	PVT	POLYVISOL WITH FE	NO	NO	NONE~ ()~NULL~~In Patient|NONE~ ()~NULL~~In Sibling1		1						1	Hypotonia; Irritability	FLU3~SANOFI PASTEUR~U2742AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333154	11/24/2008	CA	7.0	7		F	11/24/2008	GAVE PATIENT SECOND FLU SHOT WHEN NOT NEEDED									U	11/22/2008	11/22/2008	0	UNKNOWN	PUB	PVT	NONE	NONE	NONE			1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U2833AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1190X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0333158	11/24/2008	CO	32.0	32		F	11/24/2008	Within minutes of vaccine, dizziness, rest of the day dizziness and tingling all over body, day two body aches, day three to present, extreme upper arm pain/muscle weakness at site of tetanus injection (upper rt arm).									U	11/19/2008	11/19/2008	0		PUB	PVT	none	one week post bronchitis	none	high fever,seizuers~Pertussis (no brand name)~NULL~1.00~In Patient		1						1	Dizziness; Injection site pain; Muscular weakness; Pain; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~66521-0111-10~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~49281-0291-10~3~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0333159	11/24/2008	FL		56		F	11/24/2008	2 days following receiving Pneumonia vaccine noticed swelling and redness at injection site.  3 days later went to ER and received IV antibiotics.  Diagnosis was cellulitis.				Y					Y	11/18/2008	11/20/2008	2		UNK	PVT	unknown	unknown	unknown			1						1	Cellulitis; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~u2748AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1541U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0333160	11/24/2008	VA	44.0	44		F	11/24/2008	Approx 24 - 30 hrs after receiving PPV23, pt developed fever of 101 po, chills.  Injection site red, swollen, tender, approx 3 inches in diameter.  Area of swelling continued to enlarge to about 6 inches the next day.  Was seen by M.D. on 10/17/08.   Per M.D., possible viral/bacterial infection beginning in airway before injections which cross react with strep pneumo antigen or only strep pneumo vaccine local reaction, esp. if had high titer previously.  Temp at MD 99.1 on 10/17/08.  Treated for cellulitis with Dicloxacillin X 10 days.  Phone call to pt on 10/23/08, injection site improving on antibiotics, feeling better.				Y					Y	10/14/2008	10/15/2008	1		PUB	PVT		nons	none known			1						1	Body temperature increased; Cellulitis; Chills; Injection site erythema; Injection site pain; Injection site swelling; Pyrexia; Respiratory tract infection	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89685~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0990U~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0333162	11/24/2008	OH	47.0	47		M	11/24/2008	47 WM never-smoker with HTN and h/o MI x 2 (12/97 and 4/98) s/p PTCA of RCA and mid LCX, and family history of early cardiovascular disease, who presents to clinic as a transfer from Medical Center with concern for GBS secondary to recent influenza vaccine administration on 10/22/08. He had been in his usual state of health from that point until 11/15/08, at which time he developed bilateral paresthesias of his toes, then fingers, then the following day a continuous sensation of Left>Right LE progressive strength deficit, beginning in the feet, up to the knees, to the hips.  n 11/19/08, he developed Left-sided facial weakness and diminished sense of taste. Diagnosis of GBS. Please contact M.D. for additional information.   12/26/08-records received for DOS 11/20-11/25/08-DC DX: Guillain-Barre syndrome. Presented on 11/19/08 with C/O bilateral toe and finger paresthesias later progressing throughout day to include feet, knees and hips. Developed left-sided facial weakness and diminished sense of taste. Treated with IVIG. PE: absent patellar, Achilles and triceps reflexes. Complete left upper and lower facial paralysis consistent with cranial nerve 7 distribution. Discharged to rehabilitation facility.			Y		Y	5			U	10/22/2008	11/15/2008	24	Please contact the patient's physician for additional information. 12/26/08-records received-Lumbar puncture protein 108. EMG test demonstrated absent Fan d H reflexes suggestive of acute inflammatory demyelinating polyneuropathy affecting both lower extremities and to lesser extent bilateral upper extremities.	UNK	UNK			12/26/08-records received-PMH: HTN, HPL and history of MI x 2 s/p PTCA of RCA and mid LCX.			1						1	Asthenia; Dysgeusia; Facial paresis; Paraesthesia; Sensory loss	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0333165	11/24/2008	CA	32.0	32		F	11/24/2008	4 days following vaccination i developed a severe coough, congestion and body pain. I had a mild fever for a day too.  I am on over the counter medication ( robutussin + advil )Its been 3 days and my congestion and cough have not yet cleared.										11/17/2008	11/21/2008	4	None done to date	PVT	UNK		None	None			1						1	Cough; Pain; Pyrexia; Upper respiratory tract congestion	FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0333168	11/24/2008	PA	55.0	65		F	11/20/2008	Immediately upon vaccination, the site bruised and swelled @ 2cm diameter and 1cm high									U	11/20/2008	11/20/2008	0		UNK	PVT						1						1	Immediate post-injection reaction; Injection site haematoma; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA389BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0333169	11/24/2008	MA	40.0	40		F	11/24/2008	24 hours after receiving Afluria experienced symptoms of peripheral neurtits   Tinglin pain and cramps in bilat lower extremities which felt likeants crawling up legs									Y	10/31/2008	11/01/2008	1		PVT	PVT	none	none				1						1	Muscle spasms; Neuropathy peripheral; Pain in extremity; Paraesthesia	FLU3~CSL LIMITED~0459111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0333172	11/24/2008	IL	37.0	37		F	11/24/2008	client called to inofrm that 0n 11-20-2008 she received influenza and tetnus immunization and on 11-22-2008 her arm where she received the tetus shot swelled and was red and painful. she took ibp fro discomfort and today 11-24-2008 it is much better									Y	11/20/2008	11/22/2008	2		PUB	PUB		None				1						1	Discomfort; Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2743AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~UNKNOWN MANUFACTURER~U20178DA~6~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0333173	11/24/2008	OK	0.67	0	.7	F	11/24/2008	Shot given at approximately 8:30 am.  Patient vomitted at 3:00 pm later the same day.									U	11/24/2008	11/24/2008	0		PUB	UNK	Keflex antibiotic (last day)	Suspected UTI				1						1	Vomiting	FLUX~UNKNOWN MANUFACTURER~~2~UN~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0333174	11/24/2008	MA	60.0	60		F	11/24/2008	Patient developed high fever 102.3 degrees within 3 hours of receiving vaccination, followed by diffuse urticarial rash <12hr from vaccination as well as cough, arthralgias, wheezing, and hoarseness.  She was given oral steroids by a covering physician over the weekend. No prior history of egg allergy or reaction to any vaccine.				Y					U	11/20/2008	11/20/2008	0		PVT	UNK	NEURONTIN, NEXIUM, LEVOTHYROXINE, ETODOLAC, ZOLPIDEM	NONE	GERD, RSD FROM ROTATOR CUFF TEAR, CHRONIC LOW BACK PAIN, FIBROCYSTIC BREAST DISEASE, PARTIAL THYROIDECTOMY, PREVIOUS ALLERGIC REACTION TO AUGMENTIN.			1						1	Arthralgia; Cough; Dysphonia; No reaction on previous exposure to drug; Pyrexia; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U2849AC~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333175	11/24/2008	CA	18.0	18		F	11/24/2008	11/19/08 1200p Flu iz given--11/20/08 1200a pt awoke with itching, hives, periorbital swelling. 200p pt went to HC,given kenalog observed, released at 245p. Returned to HC at 400p with hives, tongue swelling, facial swelling,given epi,benadryl,started on zyrtec. Rx epipen. Drove home. 11/21/08 Recurrence of symptoms at home. Seen by PMD at emergency room and released. 11/22/08 Recurrence of symptoms, admitted to hospital on IV prednisone. 11/24/08 she remains hospitalized with plans to wean and discharge today. 12/10/08-records received-DOS 11/22-11/24/08-presented with history of facial rash and eye swelling, difficulty swallowing, seen in ED prior to this admission for these complaints. Started on steroids C/O feeling nauseated. Developed chest discomfort. Passed out at home, hives getting worse. Acute Allergic reaction with probably delayed hypersensitive reaction likely due to influenza vaccine.					Y	2			Y	11/19/2008	11/20/2008	1	12/10/08-records received-WBC 18.7, neutrophil percentage increased 85.2, lymphocyte percentage decreased 8.6, Chest x-ray normal. EKG done normal.	UNK	UNK	Vitamin C supplements	none	eczema			1						1	Eye swelling; Pruritus; Swelling face; Swollen tongue; Urticaria	FLU3~SANOFI PASTEUR~U2745AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0333176	11/24/2008	CA	4.0	4		F	11/24/2008	Pt presented to clinic 11/24/08 at 9am with c/o swelling, pruritis, erythema, and pain to L upper arm. Pt received DTap and IPV at that site on 11/21/2008 @ this clinic. Per pt's mother, symptoms are improving. No erythema appreciated. No current c/o itching. No fever, no streaking. Pt has been icing the site and taking tylenol for pain.									U	11/21/2008	11/22/2008	1		PUB	PUB		None	None			1						1	Injection site erythema; Injection site pain; Injection site pruritus; Injection site swelling	DTAP~SANOFI PASTEUR~c2956ba~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89985~5~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~a1060~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1210x~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1187x~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0333177	11/24/2008	VA	40.0	40		M	11/24/2008	I got a flu vacine shot on October 23, 2008.  Felt sick right after and had flu like symptoms for 2 weeks and then started to feel better. On November 10 I started to get numbness in my finger tips.  On November 11 my hands and feet started tingling and going numb.  I also had weakness in my legs.  On November 12 total numbness in my hands and feet and extreme weakness in legs, and shoulders.  I was admitted into the hospital and my symptoms got worse until I couldn't walk and had problems breathing.  They peformed a spinal tap and did a EMG and dignosed me with Guillain-Barre Syndrome.  Dr. started me on imuoglobin IV drip for 4 days and the Guillain-Barre Syndrome started to reverse itself.  12/1/08 MR received for DOS 11/12-17/2008 with D/C DX: Acute Inflammatory Polyneuropathy.  Lower extremity weakness.  Ataxia.  Double vision.  Insomnia.  anxiety. Pt presented to ER with rapidly progressing sensory loss and weakness of the distal extremities. Pt having difficulty walking and myoclonic jerks of the torso. PE (+) for distal weakness with grip and ankle extensors. Absent reflexes lower and trace upper. Diminished sensory perception plantar surface of foot. Ataxic gait with jerking of torso. Tx with IVIG with improvement. Able to walk with a walker. Easy fatigability.			Y		Y	8			Y	10/23/2008	11/12/2008	20	Labs and Diagnostics:  AST 48. ALT 57. CK 506. Myoglobin 256. Aldolase 12.3. ANA 151.  CSF with 9 WBC-54% neutros, 36% lymphs, 10% monos, (+) RBC, CSF protein 67. CSF cx (-). Brain MRI WNL. Head CT (-).	UNK	UNK			PMH: obesity, anxiety, insomnia			1						1	Abasia; Blood product transfusion; Dyspnoea; Electromyogram; Guillain-Barre syndrome; Hypoaesthesia; Immediate post-injection reaction; Influenza like illness; Lumbar puncture; Malaise; Muscular weakness; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~900-08-88636~4~ID~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0333178	11/24/2008	TX	7.0	7		F	11/24/2008	Developed Erythema Multiforme within a few days of flu mist vaccine.  Developed same reaction one year ago after injectable flu vaccine.									Y	09/20/2008	09/21/2008	1		PVT	PVT	None	None	None	Erythema Multiforme~Influenza (Seasonal) (no brand name)~0~6.60~In Patient		1						1	Erythema multiforme	FLUX~UNKNOWN MANUFACTURER~?~1~IN~NS~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0333181	11/24/2008	MA	54.0	54		F	11/18/2008	Fever 103 degrees, angioedema, allergic asthma, abdominal pain, systemic anaphylaxis, severe psychiatric manifestation, depression, hallucinations, no sleep, dehydration, weakness malaise.			Y						U	11/04/2008	11/04/2008	0	None	OTH	PUB	HIA	None	Psychiatric disorders; Asthma; Fibromyalgia; Carpel tunnel syndrome			1						1	Abdominal pain; Anaphylactic reaction; Angioedema; Asthenia; Asthma; Condition aggravated; Dehydration; Depression; Hallucination; Insomnia; Malaise; Mental disorder; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA17AA~3~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Life Threatening	Influenza
0333182	11/24/2008	CT	10.0	10		M	11/17/2008	1 febrile and 2 afebrile seizures within 24 hours of FLUMIST.  12/2/08 Reviewed ER medical records of 11/13/2008. FINAL DX: seizures Records reveal patient experienced blurry vision, eye deviation, drooling, unable to speak or move followed by shaking movements then confusion, sleepiness, groaning, abdominal pain, vomiting x 30 min before returning to normal.  No further seizure activity & d/c to home w/neuro clinic f/u as outpatient.				Y	Y	1			Y	11/12/2008	11/13/2008	1	EEG	UNK	UNK		No	None  PMH: epilepsy w/seizure 3 yrs prior s/p head trauma.			1						1	Convulsion; Electroencephalogram; Febrile convulsion	FLUN3~MEDIMMUNE VACCINES, INC.~500569~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0333183	11/24/2008	VA	72.0	72		F	11/24/2008	Arm swollen till elbow, rash on upper body, lump on the site. High fever 101.7 ok on 11/24/2008 arm yellow. Taking NAPROXEN and BENADRYL,  for PNEUMOVAX.									Y	11/21/2008	11/21/2008	0	None	OTH	UNK						1						1	Injection site mass; Oedema peripheral; Pyrexia; Rash; Rash papular; Skin discolouration	FLU3~SANOFI PASTEUR~2L06AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1076X~2~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0333184	11/24/2008	CO	1.3	1	.3	M	11/18/2008	10 days after vaccine localized reaction, possible cellulitis at site of injection occurred. (site of injection of varicella). At day 3 of abx significant improvement.				Y					Y	11/07/2008	11/17/2008	10	WBC 12.6	PVT	PVT	Amoxicillin	Sinusitis	None			1						1	Local reaction; White blood cell count increased	DTAP~SANOFI PASTEUR~C2999AA~4~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2785CA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0976X~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0333185	11/24/2008	IL	65.0	65		F	11/14/2008	Necrotic ulceration at Injection site - 4 cm. Large eschar developed. Treated with Bacitracin Ointment.				Y					Y	10/28/2008	11/01/2008	4	None	PVT	OTH	Lasik, Verapamil, Detrol,Allegra, Mevacor, Chantix		PCN			1						1	Eschar; Injection site necrosis; Injection site ulcer	FLU3~SANOFI PASTEUR~U2274AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1225U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0333186	11/24/2008	TX	34.0	34		F	11/24/2008	At about 1:00pm I felt my throat begin to get scratchy, my eyes felt itchy. I looked in mirror and they were extremely bloodshot, watery & felt like there was a film covering my eyes. My chest felt tight and I felt palpitations randomly. My pulse was faster than normal. I began to cough because of a constant tickle in my throat. I had a dull, constant headache (like pressure). At this point temperature was 98.6. I was aching in my entire body and had no energy. This continues into the night. Could not sleep because of the headache, chest pressure (could not catch my breath). Temperature was 99.7 at 9:00pm. Took 400mg Ibuprofen 11/19/2008 the next morning no temperature, chest was still tight, fever was gone 98.8. Throat was hoarse, eyes were still runny and bloodshot and sore. This continued through the entire day with heart palpitations. 2:00 400mg Ibuprofen. 11/20/2008 woke up to normal white eyes. Energy level was low but more energy than previous days. 11/18/ & 11/19 Heart palpitations gone and throat was normal. Have felt no effects to date.									Y	11/18/2008	11/18/2008	0	None taken	OTH	PUB	Unknown	None	HTN			1						1	Chest discomfort; Cough; Dysphonia; Eye pruritus; Headache; Heart rate increased; Insomnia; Lacrimation increased; Ocular hyperaemia; Pain; Palpitations; Pyrexia; Throat irritation	FLU3~SANOFI PASTEUR~U2739AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333187	11/24/2008	TX	55.0	55		F	11/24/2008	30 min- shooting pains down injection site arm, extreme joint pain. very joint- clammy-felt like I had the flu, extreme fatigue. hard to breathe- (3 days of symptoms)									Y	11/04/2008	11/04/2008	0	None	UNK	PVT		Little bit of cold				1						1	Arthralgia; Cold sweat; Dyspnoea; Fatigue; Influenza like illness; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89884~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333188	11/24/2008	CO	26.0	26		F	11/24/2008	Pain, inflammation, redness at injection site.									Y	11/24/2008	11/24/2008	0		OTH	OTH						1						1	Injection site erythema; Injection site inflammation; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~87877~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333192	11/24/2008	WA	69.0	69		F	11/21/2008	2 days after vaccination patient experienced nausea and developed flu like symptoms. Nausea began to subside 4 days later. She never vomited, but still has no appetite. Her naturopath told her vaccine is live and toxic, and her immune system can't fight it. Patient's MD told her it is not a live vaccine. She doesn't believe him due to statement by naturopath.									Y	11/14/2008	11/16/2008	2	None	OTH	OTH						1						1	Anorexia; Influenza like illness; Nausea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333193	11/24/2008	CA	8.0	8		M	11/20/2008	Bloody nose 2am 11/20/08 stopped has had no relapse no other adverse events noted.									Y	11/18/2008	11/20/2008	2	None	PUB	PUB			None			1						1	Epistaxis	FLUN3~MEDIMMUNE VACCINES, INC.~500546~UNK~OT~LA~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0333195	11/24/2008	NC	28.0	28		F	11/24/2008	Received AVA, Fumist, & Typhoid vaccines on 10/14/2008; 1st LMP 10/1/2008; positive pregnancy test end of Oct 2008.				Y					Y	10/14/2008	10/29/2008	15	10/29/2008: hCG quant 12135.0 mIU/ml	MIL	MIL	None	None	None			1						1	Blood human chorionic gonadotropin increased; Drug exposure during pregnancy	ANTH~EMERGENT BIOSOLUTIONS~~UNK~SC~UN~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TYP~UNKNOWN MANUFACTURER~~1~IM~UN~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0333196	11/24/2008	CA	8.0	8		F	11/24/2008	8cm X 10cm induration/erythema.									U	11/22/2008	11/22/2008	0		PVT	PVT						1						1	Erythema; Induration	FLUN3~MEDIMMUNE VACCINES, INC.~500583P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~1219X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0333197	11/24/2008	OH	57.0	57		F	11/22/2008	11-22-08 - Scratchy throat, fatigue. 11-23-08 - Fever 100-101 degrees, headache. No N/V/D.									Y	11/19/2008	11/22/2008	3		PUB	PVT		None	None			1						1	Fatigue; Headache; Pyrexia; Throat irritation	FLU3~SANOFI PASTEUR~42768AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333198	11/24/2008	PA	29.0	29		F	11/28/2008	Approx 1 hour after receiving flu shot, I started feeling severely achy all over. By that evening I was vomiting, diarrhea, and had a fever of 102.0 deg. This continued for 3 1/2 days.									Y	11/18/2008	11/18/2008	0		PVT	PVT		None	None			1						1	Diarrhoea; Pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2811AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333201	11/24/2008	GA	10.0	10		M	11/24/2008	Presented with warm, 12x8cm maculo papulo lesions over the area of varicella vaccine, 1 day after injection.  No treatments given.									Y	11/18/2008	11/19/2008	1		PVT	PUB						1						1	Feeling hot; Rash maculo-papular	FLU3~SANOFI PASTEUR~U2830AA~3~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B029AA~1~IM~UN~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1216X~2~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0333180	11/25/2008	MN	22.0	22		F	11/25/2008	Initial large hives on the arm of the injection between shoulder and elbow, spreading down to forearm after two days. Extremely itchy and painful. Treated with anti-itch cream and oatmeal paste. Pain radiated up from injection site and into jaw, causing pain similar to toothache. Treated with OTC pain relievers. Fever and chills followed after two or three days of initial onset. Reaction subsided around/after November 18-19th, 2008.									Y	11/06/2008	11/12/2008	6	Contacted emergency nurse line late night, instead of going into urgent care or emergency. Was directed to monitor hives and their spread. Was told to go to emergency if hives spread to palms, soles of feet, or if throat started to close up. Directed to take antihistamine, apply cold packs to the affected areas, and continue to apply oatmeal paste to soothe itching. Also directed to take OTC pain relievers, as needed.	PUB	UNK	Insulin, vitamin C		Allergy to dust and mold. Asthma. Type I diabetes.			1						1	Chills; Injection site pain; Injection site urticaria; Pain in jaw; Pruritus; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0333212	11/25/2008					U	11/25/2008	On 11 November 2008 we received a literature article. The authors conducted a case-cohort study estimating effectiveness of inactivated influenza vaccine in preventing inpatient/outpatient visits (emergency department [ED] and outpatient clinic). They compared vaccination status of laboratory-confirmed influenza cases with a cluster sample of children from a random sample of practices in 3 counties (subcohort) during the 2003-2004 and 2004-2005 seasons. The study was conducted in 3 counties. Children were defined as fully vaccinated if they received: (1) 2 vaccine doses in an influenza season, more than 24 days apart, with the second dose more than 14 days before ARI onset or (2) more than 1 vaccine dose in a prior influenza season and 1 dose in the current season more than 14 days before ARI onset. Children were partially vaccinated if they received (1) only 1 of 2 recommended doses during the current season more than 14 days before ARI onset or (2) 2 doses during the current season, with the second dose less than 24 days after the first or within 14 days of ARI onset. All other children were unvaccinated. During the 2003-2004 season a total of 8/210 children (who were fully vaccinated) and 21/210 children (who were partially vaccinated) experienced influenza infection. The authors identified 6 fully vaccinated children 6-23 months of age, and 13 partially vaccinated children 6-23 months of age, and 2 fully vaccinated children 24-59 months of age, and 8 partially vaccinated children 24-59 months of age. For the 2003-2004 season the company cannot exclude that the children received a Novartis influenza vaccine. During the 2004-2005 season the company had no product on the market. We received on 18 NOV 2008 and on 19 NOV 2008 from the author the information, that he has no further information. No change in assessment.									U					OTH	OTH	No other medications	Unknown			MA20082849	1						1	Influenza	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333261	11/25/2008	IL	65.0	65		F	11/22/2008	Received vaccine Friday November 7, 2008 at ~ 8:35 am. At 12:45 pm Friday Nov. 7, 2008 experienced very sudden onset of: 1. congestion in area near epiglottis/upper trachea requiring continuous attempts to clear throat of mucous; mild-to moderate non-productive cough with mild wheeze-like sounds on expirations.  2. throat in above area had burning/raw and some itching sensations.  3. about 10 minutes later pharynx presented with same burning/raw and some itching sensations; uvula was reddened with mild swelling (approximate 1.25 - 1.5 X normal size).  4. about 15 minutes after onset of symptoms 1-3, took 2 mg. Chlorpheniramine.  5. at same time as #3, experienced start of mild headache but also moderate lightheadedness; there was no dizziness or vertigo.  6. about 1 hr later sensation in throat and pharynx progressed to nares. 7. was extremely cold but did not experience shaking chills; lasted for ~ 4hrs. after onset of pulmonary symptoms.  8. frequent hourly urination which started approximately 1/2 hour after initial symptoms (see #1 above) began; dipstick was negative for UTI (negative leukocyte esterase and nitrite).  9. symptoms in epiglottis area/upper trachea started to abate in about 20-30 minutes post administration of antihistamine noted in #4.  10. all symptoms were basically resolved by 9 hours post initiation of adverse reactions; did feel tired but next morning basically OK except some residual clearing of throat (not uncommon with concurrent ragweed/grass allergy symptoms at this time.									Y	11/07/2008	11/07/2008	0		OTH	PUB	CLIMARA PATCH - 0.1 mg weekly, Lorazepam 1mg TID	Seasonal allergies.	Seafood/fish; pollens/ragweed; Cortisone (DECADRON); episodic PVCs, mild Mitral valve regurgitation.			1						1	Cough; Cough; Dizziness; Enlarged uvula; Fatigue; Feeling cold; Headache; Nasal discomfort; Pharyngeal erythema; Pollakiuria; Rhinalgia; Throat irritation; Throat irritation; Upper respiratory tract congestion; Urine analysis normal; Wheezing; Wheezing	FLU3~CSL LIMITED~04549111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0333262	11/25/2008	MN	35.0	35		F	11/21/2008	Patient presented to clinic about 20 minutes after receiving FLUVIRIN c/o throat swelling (mild) described as cotton throat no shortness of breath, no facial, tongue, or lip swelling, c/o mild dizziness. No prior reaction to FLUVIRIN. VSS IM Benadryl 50mg. given with significant improvement of symptoms, improved throat. Within 30-40 minutes after receiving Benadryl 50mg x 1 dose, patient reported significant improvement of throat swelling about 75% improvement. Dizziness improved after ate a nutrition/ energy bar and water. Vital signs stable. Ortho-static BPS/HR stable. HEENT/Respirtory/Cardiac and Neuo exam all stable/ normal. Alert and oriented x3 patient discharged in stable condition and advised to call 911 if symptoms recurred or worsened. Patient expressed understanding of plan. Advised to discuss future eligibility for FLUVIRIN vaccine with her primary care provider and inside under allergy skin testing.									Y	11/21/2008	11/21/2008	0	Vital signs stable: 114/74, 107/70, 103/73 HR 74; 100% PO2 sat	PUB	OTH	Whole food multivitamin capsule; none	None	(PMH non-Hodgkin lymphoma 2004 -> remission since 2005); allergies to all narcotics; Iodine-Hive			1						1	Blood pressure normal; Dizziness; Ear, nose and throat examination normal; Heart rate normal; Neurological examination normal; No reaction on previous exposure to drug; Oxygen saturation normal; Pharyngeal oedema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89994~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333265	11/25/2008	IL	49.0	48		M	11/25/2008	09/10/2008 Pain in injection area, increasing left shoulder pain 09/17/2008, left shoulder/chest pain. 9/26/2008 Anaphactic reaction all over body pain, weakness. 10/08 all over body pain/weakness, chest pain. 11/08 all over body pain/weakness and still has chest pain.				Y					N	09/08/2008	09/10/2008	2	C reactive protein; CPK; ANA; CMP; ESR; ALDOSE; autoimmune profile, anti smooth muscle, AB; Antimitochondrial AB; component CB, 34; EKG; chest CT; persatine stress test	PVT	OTH	SINGULAIR; PREDNISONE, since 9/08; VICODIN, for pain; MVI; ZYRTEC	Injured right finger nail	Asthma			1						1	Aldolase; Anaphylactic reaction; Antimitochondrial antibody; Antinuclear antibody; Asthenia; Blood creatine phosphokinase; C-reactive protein; Cardiac stress test; Chest pain; Computerised tomogram; Electrocardiogram; Injection site pain; Metabolic function test; Musculoskeletal pain; Pain; Red blood cell sedimentation rate; Smooth muscle antibody	FLU3~SANOFI PASTEUR~U2749AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333269	11/25/2008	KS	34.0	34		M	11/25/2008	Received flu vaccine and Tdap on same day - reports soreness at Tdap injection site for a couple days but has had shoulder stiffness since then. Denies redness, edema, numbness or tingling in arm just stiff and tired at end of day especially when raising arm above head.									N	11/06/2008	11/09/2008	3	None	OTH	OTH	None	None	None			1						1	Erythema; Fatigue; Hypoaesthesia; Injection site pain; Musculoskeletal stiffness; Oedema peripheral; Paraesthesia	FLU3~SANOFI PASTEUR~U2802AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2998BA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0333271	11/25/2008	FL	26.0	26		M	11/25/2008	Recieved flu vaccine 2 1/2 weeks ago and since that time has had progressive parasthesia of the upper extremeties. Admitted to Hospital 11/15/08, discharged 11/19/08. Guillain Barr syndrome versus transverse myelitis.  2/18/09 Received hospital medical records of 11/15-11/19/2008. FINAL DX: no d/c summary dictated.  Neuro consult: favor transverse myelitis. Records reveal patient experienced progressive tingling/numbness of hands & feet, heaviness of extremities x 2 weeks.  Neuro & Neurosurg consults done.  3/16/09 Received additional hospital medical records of 11/15-11/19/2008. FINAL DX: no d/c summary dictated.   Records consisted of ER records & labs.					Y	4			Y	10/30/2008	11/15/2008	16	MRI of C spine and brian with and without contrast; lumbar puncture; EMG's and nerve conduction studies; Sed rate, ANA, B 12 and Folate  LABS: CBC, BMP, CT brain, MRI brain & c-spine WNL. CT c-spine w/disc extrusion C5-C6.  CSF glucose 58, protein 33, wbc 1, rbc 0, oligclonal bands neg.  Vit B12 175(L)	UNK	UNK	unknown	none	unknown	~ ()~UN~0.00~In Patient		1						1	Electromyogram; Lumbar puncture; Nerve conduction studies; Paraesthesia; Red blood cell sedimentation rate	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89685~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0333274	11/25/2008	MA	49.0	49		M	11/25/2008	At 8pm 11hours after vaccine administration experienced muscle aches all over  At 9pm experienced chills and shivering  At 10pm high fever  The next day felt okay but just tired and sore  At time of report, feeling fine									Y	11/21/2008	11/21/2008	0	none	PUB	PUB	none	none	none			1						1	Chills; Fatigue; Myalgia; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA191AA~2~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0333277	11/25/2008	PA	3.0	3		F	11/25/2008	Pt recieved FluMist on 11/18/08 next day mom noticed weak facial muscle on left. On Friday 11/21 to ER dx with Left Facial Palsy, started on Prednisone. No antecedant illness. Patient in usual stae of health. Follow up today, PE just for left facial palsy.				Y					U	11/18/2008	11/19/2008	1	Lyme titer pending	PVT	PUB	None	Perfect health	None			1						1	Borrelia burgdorferi serology; Facial palsy; Muscular weakness	FLUN3~MEDIMMUNE VACCINES, INC.~500561D~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0333278	11/25/2008	NY	22.0	22		F	11/25/2008	Red arms and stuffy nose appeared approximately 3 hours after administration of flu shot.Was seen at MD office. DX:   ? Adverse Reaction Flu Shot. RX: Claritin 10 mg 1 po q day x 4. After administration of Claritin symptoms resolved.  Patient has had influenza  vaccine before without any adverse reaction.				Y					Y	10/15/2008	10/15/2008	0	NONE	PUB	PUB	Clozapine, Lithium Carbonate, Zoloft, Provigil, Nexum	none	DX: Major Depression with Psychotic features, Personality Disorder, Acute Peptic Ulcer.  Allergies: Cipro,PCN, tomatoes, milk			1						1	Erythema; Nasal congestion; No reaction on previous exposure to drug	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88117 3P~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0333280	11/25/2008	NH	4.0	4		M	11/25/2008	Large red welt around where vaccine was administered in Right deltoid. Warm to the touch, itchy. Treatment- Benedryl every 4-6 hrs as needed for itchiness, swelling.									Y	11/19/2008	11/20/2008	1		PVT	UNK						1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Injection site urticaria; Injection site warmth	DTAP~SANOFI PASTEUR~C2957AA~5~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2799CA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A1060~4~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1743U~2~IM~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0333281	11/25/2008	AR	45.0	45		F	11/25/2008	swollen glands-behind right ear, scalp, neck, throat area, left cheek				Y					U	11/10/2008	11/23/2008	13		PUB	PUB	Avalox, Ibuprofen, Tylenol, Singulair, Zyrtec, Lexapro, Xanax	none	Seasonal Allergies	flu-like symptoms~Influenza (Seasonal) (Fluzone)~1~45.00~In Patient		1						1	Lymphadenopathy	FLU3~SANOFI PASTEUR~U2807AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0725X~3~IM~LA~HEP B (RECOMBIVAX HB)~1|MMR~MERCK & CO. INC.~0811X~3~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1903U~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0333282	11/25/2008	TX	0.92	0	.9	F	11/25/2008	Blisters in mouth over night after getting flu vaccine				Y					U	11/24/2008	11/24/2008	0		PVT	PUB	accuhist pdx 1/2 dropper every 6 hours	allergic rhititis, cough at night	no prior medical history			1						1	Oropharyngeal blistering	FLU3~SANOFI PASTEUR~UT2788FA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333283	11/25/2008	NY	36.0	36		F	11/25/2008	Dull, aching, chronic pain in right shoulder where flu shot was administered.  Pain has lasted since flu shot was first administered on October 23, 2008.  Was seen by a medical doctor who recommended physical therapy to strengthen arm back to normal.  Treatment begins next week.				Y					N	10/23/2008	10/23/2008	0	Only flu vaccine was administered.	PUB	PVT	n/a	dull, aching pain in right shoulder began at time of shot and has not ceased.				1						1	Injection site pain	FLU3~SANOFI PASTEUR~U2771AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333284	11/25/2008	FL	78.0	78		M	11/25/2008	Started with confusion and disorientation abou 3-4 days afterwards which developed into a full bown encephalitis.  Presently in an intensive care unit at Medical Center.  1/6/09 Received hospital medical records of 11/13/08-12/20/2008 FINAL DX: No d/c summary dictated.  Consults mention multisystem organ failure, fever, cellulitis, UTI, acute renal failure, syncope Records reveal patient being treated for UTI x approx 1 week.  Developed confusion, weakness, malaise, dizziness, fever, fall w/amnesia, lethargy, rash mostly over LEs.  Fever 101.5 in ER.  ID, Neuro, Uro,  Nephro, Pulmo, Heme consults done.  Developed diabetes, dysphagia, hypernatremia, drug induced thrombocytopenia, liver encephalitis, polymicrobial sepsis w/feeding tube disruption, intra-abdominal infection & acute respiratory distress.  Admitted ICU & intubated.  LP done.  Tx w/IV antibiotics, antivirals, antiseizure meds, steroids, PEG tube feeding, plasmapheresis, dialysis.  Continued downhill course & transferred to hospice on 12/20/08.	Y	12/20/2008	Y	Y	Y	37	Y		U	11/06/2008	11/13/2008	7	LABS: Brain biopsy.  CSF: WBC 141( H), lprotein 135(H), glucose 161(H), c/s (+) strep grp B & S. simulu.  Initial CT brain scan, MRI brain & CXR WNL. Later CT brain revealed bilateral SDHs.   Paracentesis fluid: WBC 1822(H), lymphs 5%(H), polys 95%(H), c/s (+) candida.  CBC, ammonia, B12, folic acid, ESR, TSH WNL.    LFTs (H).  Sodium 133. UA abnormal.  Blood c/s (+)E.faecal, E. coli, S. Eeider, candida.  Urine c/s (+) E. coli & candida.  Sputum c/s(+) psuedomonas & Strep Grp B.  EEG c/w diffuse encephalopathy, no seizures.  CT abdomen & renal US (+) multiple nonobstructing bladder & kidney stones.  US doppler of LEs neg.	UNK	UNK	Cozaar, Lipitor, Flomax	None	Hypertension, hyperlipidemia, benign prostatic hypertrophy  PMH: obesity, kidney stones,			1						1	Confusional state; Disorientation; Encephalitis; Intensive care; Delirium; Dementia; Encephalitis; Intensive care	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA209AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA209AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~2	USA	Results in Death	Influenza
0333285	11/25/2008	TX	55.0	55		F	11/25/2008	Received vaccine 11/19/08 @ noon approximately 12 hours later reported vomiting and diarrhea.  Saw her private MD and Dr. told her she had a reaction to the flu vaccine.  Patient returned to work 3 days later.				Y					Y	11/19/2008	11/20/2008	1	None known	UNK	UNK	Nexium, Cardizem, Lo-est	None admitted.	Iodine	~ ()~0~0.00~In Patient		1						1	Diarrhoea; Vomiting	FLU3~SANOFI PASTEUR~U2848AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333287	11/25/2008	VT	5.0	5		F	11/25/2008	My daughter had the LAIV (nasal spray) and had a severe reaction - hives from her head to her toes.  She needed to be on steroids to bring relief.  Not sure if doctor reported this reaction.									Y	11/11/2008	11/12/2008	1		UNK	UNK		None, but did have a UTI two weeks prior and was on Keflex for 10 days	None			1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0333288	11/25/2008	OH	56.0	56		F	11/25/2008	Client had never received flu shot in past. Administered at flu clinic at 11:00am. Client noticed itching tongue at 4:00pm. It then became swollen and she went to the Emergency room at 5:00. She was given Benadryl and a shot?? Client unsure what the shot was. She states symptoms were gone within 1 hour and she was discharged. She took 3 more doses of Benadryl throughout the evening/night. No further problems.				Y					Y	10/20/2008	10/20/2008	0		UNK	UNK						1						1	Oral pruritus; Swollen tongue	FLU3~SANOFI PASTEUR~U2768AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333289	11/25/2008	PA	53.0	53		F	11/25/2008	itchy rash on upper arms, thighs, & bra line; new areas appearing right elbow 7 days after injection; calamine lotion was applied by pt.									Y	11/12/2008	11/13/2008	1		UNK	PUB	none	no	summer-hay fever			1						1	Rash pruritic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8805~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333290	11/25/2008	WI	49.0	49		M	11/25/2008	Fever up to 101, achy, headache, dizzy   Patient received injection on Thursday 11/20/08 and symptoms started Saturday 11/22/08. Patient feels some better today 11/25/08. He will update prn.									U	11/20/2008	11/22/2008	2		UNK	UNK						1						1	Dizziness; Headache; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2772AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~UF455CA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0333292	11/25/2008	FL	66.0	66		F	11/25/2008	Site of vaccine was 2 inches in diameter, red, warm to touch , painful. Client was instructed to apply cold compress and use analgesic as needed.										11/24/2008	11/24/2008	0		UNK	PVT		None	Allergy to sulfa			1						1	Injection site erythema; Injection site pain; Injection site warmth; Injection site erythema; Injection site pain; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA166AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0333293	11/25/2008	IA	62.0	62		M	11/25/2008	On 10/30/08 pt stated arm swollen, extremely hot and sore at elbow which lasted until Friday.  On Saturday symptoms improved and he returned to work on Monday.  On 10/30/08 he also went to Dr. and they gave him penicillin QID.				Y					Y	10/29/2008	10/30/2008	1		UNK	PVT						1						1	Arthralgia; Oedema peripheral; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89979~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0990u~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0333294	11/25/2008	PA	43.0	43		F	11/25/2008	Had headache, body aches, high fever lasted 12 hours									Y	11/13/2008	11/13/2008	0		UNK	UNK						1						1	Headache; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88850~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333297	11/25/2008	SD	4.0	4		M	11/05/2008	No fever.  Mom stated it started with blotchy bumps on arm and rash on neck noted at bedtime.  Pinpoint rash on right side of back and stomach.  Rash area itchy.  She gave him benadryl last night.  He slept well.  This AM child has football shaped reddened area on upper arm of injection site that is about 3.5 in long.  She described knees and feet as sunburned red.  I advised seeing childs doctor.				Y					Y	11/04/2008	11/04/2008	0		PUB	PUB						1						1	Erythema; Injection site erythema; Injection site swelling; Rash macular; Rash pruritic	FLU3~SANOFI PASTEUR~U2811AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333298	11/25/2008	CA	10.0	10		F	11/25/2008	Patient had a seizure 3 minutes after having the Flu -mist. We were still in the doctors office.									U	10/24/2008	10/24/2008	0		UNK	UNK	none	none	none			1						1	Convulsion; Immediate post-injection reaction	FLUN3~MEDIMMUNE VACCINES, INC.~~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0333301	11/25/2008	MO	68.0	68		M	11/25/2008	11 November 2008 I got the flu shot in my left arm. About 6 to 8 hours following the shot I started getting muscle ache in my left shoulder. I took ibuprofen to try to releive the pain. After almost a week with the pain I went to a chiropractor who said that he could no cause for the pain except possibly the flu shot. He gave me a treatment but it had no effect. Today I went back to the doctors office where I got the flu shot and they are prescribing a pain medication and a muscle relaxant which I have not yet picked up from the drugest. The person who gave me the shot said that I should call the CDC and they told me to fill out this form. If others have reported this same side effect please let me know.									N	11/11/2008	11/11/2008	0		PVT	PVT		None.	CLL			1						1	Myalgia	FLUX~UNKNOWN MANUFACTURER~~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0333303	11/25/2008	MO	39.0	39		F	11/25/2008	Recieved shot on Monday Nov 10, 2008, Woke up Tuesday with a sore throat, Wednesday arms started itching by Thursday red Welts started showing up and covered both arms and a few red itchy welts showed up on the Abdomen. I was diagnosed with Hives due to an alergic reaction to something..........				Y					Y	11/10/2008	11/11/2008	1	none	UNK	UNK	Yaz	none	alergic to Sulfa, fruit pectin and some nuts			1						1	Erythema; Hypersensitivity; Oropharyngeal pain; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0333312	11/25/2008	NJ	69.0	69		F	11/25/2008	T.C. from Pt. at 2:50pm 11/25/08; reports swelling of (R) arm when PNEUMOVAX was administered. Stated symptoms began approximately 2 hrs post vaccination. Advised to apply ice, take ibuprofen every 4-6 hrs; call physician  if symptoms persists.										11/24/2008	11/24/2008	0		PUB	UNK		None	None			1						1	Injection site swelling; Injection site erythema; Injection site pain; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA181AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1076X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflla181aa~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~2|PPV~MERCK & CO. INC.~1076x~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0333314	11/25/2008	MO	82.0	82		F	11/25/2008	Patient complained of having weakness, heart palpitations, and soreness all  over body the evening of FLUZONE vaccination was administered. No fever noted. Doctor suggested taking Tylenol and resting.									Y	11/24/2008	11/24/2008	0	No labs done	PVT	OTH	PLAVIX, BABY ASPERIN, NITROGLYCERIN, LEVOTHYROXINE, METOPROLOL, XALANTANEY, TIMOPTIC, CELEBREX, ISORDIL	Sore throat	Allergy to Aspirin & Naprosyn			1						1	Asthenia; Pain; Palpitations	FLU3~SANOFI PASTEUR~U2752AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333317	11/25/2008	CA	86.0	86		U	11/25/2008	Nerve like pain in arm over 2 month period				Y					U	09/03/2008				OTH	PVT	PLAVIX					1						1	Neuralgia; Neuralgia	FLU3~SANOFI PASTEUR~U2750aa~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2750A~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0333318	11/25/2008	IL	54.0	54		M	11/24/2008	11/24 - reported pain/hurt through out arm since shot given on 10-22-08. Has not taken anything as of yet. Saw doctor within last few days - MD said it could take up to 3 months to get better.									U	10/22/2008	10/22/2008	0		PUB	UNK						1						1	Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA192AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0333319	11/25/2008	TX	40.0	40		F	11/25/2008	Patient received 2 vaccine injections to left deltoid muscle 1 1/2-2 apart on 11/23/2008 12:30PM; 10hrs later pain and swelling of left arm and left breast area. Described as burning; arm immobilized with pain. On 11/24/08 patient returned to pharmacy and was instructed to go to Dr's office for treatment; at Dr's office she received a steroid shot and on 11/25/08 patient awoke with symptoms diminished and had no complaints.				Y					Y	11/23/2008	11/23/2008	0		OTH	OTH		None	None			1						1	Injected limb mobility decreased; Oedema peripheral; Pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881296P~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1381U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0333321	11/25/2008	CO	80.0	80		F	11/22/2008	Localized swelling 6cm right deltoid area warm to touch slight redness surrounding swollen area. PNEUMOVAX given. Pharmacist suggested cold compress to area and Benadryl 50mg at 4-6 hours. If becomes worse to go to ER.									Y	11/22/2008	11/22/2008	0		OTH	OTH						1						1	Erythema; Local swelling; Skin warm	FLU3~SANOFI PASTEUR~U2757AA~UNK~IJ~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0990U~UNK~IJ~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0333459	11/25/2008	NC	7.0	7		M	11/20/2008	(R) deltoid- small elliptical bullous lesions.									Y	11/18/2008	11/19/2008	1	culture sent	PVT	PUB	Ritalin; Lamictal	none	RAD; ASD (autism)		NC08111	1						1	Culture; Skin lesion	FLU3~SANOFI PASTEUR~U2795EA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330216	11/26/2008	IN	54.0	54		F	11/24/2008	Initial report received on 18 November 2008 from a health care professional, the consumer, and a company representative for Sanofi Aventis. A 54-year-old female patient, who had no concurrent illnesses, and past medical history of depression and allergic rhinitis, had received an intramuscular left deltoid injection of FLUZONE SV 2008-2009 (lot number U2789CA) on 13 October 2008 at 12:15 pm with a pre-filled syringe. Ten days post-vaccination, the patient was evaluated by her physician and diagnosed with progressive atrophy at the injection site. A copy of a picture of the left deltoid area was provided. No relevant diagnostic tests or laboratory data were performed. At the time of this report, the patient had not recovered. Documents held by sender: Photo of left deltoid area.				Y					N	10/13/2008	10/23/2008	10	None	PVT	OTH	NASONEX; ZOMIG; XANAX		The patient had no concurrent illnesses at the time of the vaccination on 13 October 2008.  The patient has past medical history of depression and allergic rhinitis.		200803653	1						2	Injection site atrophy; Injection site atrophy	FLU3~SANOFI PASTEUR~U2789CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2789C~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0333284	11/26/2008	IL	78.0			M	11/26/2008	This case was reported by a healthcare professional and described the occurrence of encephalitis in a 78-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 6 November 2008, the subject received a dose of FLULAVAL (.5 unknown, unknown, left arm). On 9 November 2008, 3 days after vaccination with FLULAVAL, the subject experienced encephalitis, acute delirium and dementia. The healthcare professional was notified by a physician of an adverse event that occurred after a subject received a FLULAVAL vaccination. The subject is the physician's father. The subject was vaccination on 06 November 2008 and about three of four days later, the subject developed extreme dementia and was hospitalized. The subject was diagnosed with encephalitis and is still in the intensive care unit (ICU) at the time of the report. The reported healthcare professional did not know the facility were the subject was vaccinated at the time of the report. The physician has also completed a VAERS form and submitted to the FDA. The subject was hospitalised and the healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL.			Y	Y	Y	0			N	11/06/2008	11/09/2008	3	UNK	OTH	OTH		Unknown	Concomitant medications and relevant medical history were unknown. It was unknown if adverse events were reported with previous vaccinations. It was unknown if the subject had previously received influenza vaccinations. A VAERS form was completed and submitted to the FDA.		A0758378A	1						2	Confusional state; Disorientation; Encephalitis; Intensive care; Delirium; Dementia; Encephalitis; Intensive care	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA209AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA209AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~2	USA	Life Threatening,Hospitalisation	Influenza
0333324	11/26/2008	CO	57.0	57		F	11/21/2008	Felt malaise and sick starting 15 min post vaccination.  Later afternoon went to ER & was admitted for tachycardia.  11/26/2008 MR received for DOS 11/12-13/2008 with D/C DX: Paroxysmal Atrial Fibrillation, now in sinus.  Mild hypertension. Ptpresented to ER with tachycardia, palpitations, and SOB which began after receiving flu shot. Found to be in A-fib upon arrival with ventricular rate 130-190s. Tx with diltiazem with improvement to the 110s. No cardiac hx. Self converted to SR during stress echo. D/C on ASA.				Y	Y	1			Y	11/12/2008	11/12/2008	0	Labs and Diagnostics:  CXR WNL.  EKG shows non-specific ST-T changes and A-fib. Cardiac enzymes all normal. CBC with WBC 10.1. D-dimer WNL 109. Transthoracic echo -borderline LVH, otherwise WNL. Stress echo WNL.	PVT	PVT		None	PMH: contolled asthma, hiatal hernia with banding. Rxn to albuterol with rash, desquamation and alopecia			1						1	Atrial fibrillation; Malaise; Tachycardia	FLU3~SANOFI PASTEUR~U2766AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0333352	11/26/2008	FL	64.0	64		F	11/25/2008	Labored Breathing --> CTA in ER demonstrated bilateral ground glass consistent with inflammatory process-possible viral pneumonia.				Y						10/21/2008	11/07/2008	17	CTAngio, noted above	PVT	OTH	TOPROL XL	None	SVT			1						1	Angiogram; Angiogram abnormal; Dyspnoea; Inflammation	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA364BA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0333357	11/26/2008	NE	47.0	47		F	11/26/2008	Redness, swelling, induration of 4.3cm x 5cm. Warm to touch, tenderness, itching.				Y					Y	11/24/2008	11/26/2008	2		PVT	OTH		None	None			1						1	Erythema; Induration; Pruritus; Skin warm; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U2749AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333359	11/26/2008	NE	53.0	53		F	11/26/2008	redness, swelling- induration of 5 cm x 6 cm.  Warm to touch, severe itching tenderness				Y					Y	11/21/2008	11/23/2008	2	None	PVT	PVT		None	None			1						1	Erythema; Induration; Pruritus; Skin warm; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U2749AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333360	11/26/2008					M	11/24/2008	Initial report received on 19 November 2008 from a health care professional. A male patient had received a dose of FLUZONE SV 2008-2009 on 05 November 2008. The lot number, route and site of administration was not provided. Approximately 12 days post-vaccination, the patient began to experienced symptoms that were later confirmed by his family physician to be Bell's Palsy. It was not reported whether any diagnostic test's or laboratory data were completed. It was also not reported whether any treatment was received for the event. The recovery status of the patient was not provided. The reporter is not convinced the event is related to the vaccine. Documents held by sender: None. The reporter for this case is the same as for case 2008-03427.				Y					U	11/05/2008	11/17/2008	12	Not reported	UNK	UNK			Not reported		200803678	1						1	Facial palsy	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333362	11/26/2008	CA	64.0	64		F	11/24/2008	Pain in (L) deltoid started the day received the vaccine; only 20% better after 5 weeks of pain with shoulder ROM mildly tender to palp.									N	10/21/2008	10/22/2008	1	None	PUB	PUB	Wellbutrin; MRT; MVI	None	None Known			1						1	Injection site pain; Musculoskeletal pain	FLU3~CSL LIMITED~01749111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0333363	11/26/2008	GA	45.0	45		F	11/24/2008	The patient developed a pus filled area at the site of injection. The area then proceeded to ulcerate into 0.5x 1.5 cm area.									U	11/13/2008	11/14/2008	1	None	PVT	OTH	AMRIX, AVONEX; BENZONATE; BARBITAL; CELDINIR; DIAZEPAN; GABAPENTIN; HYDROCODONE; PREDNISOLONE; OXYCODONE; PROVIGIL; SYNTHROID; TOPANAX; VESICARE;	None	Multiple Sclerosis, Hypothyroid			1						1	Injection site pustule; Injection site ulcer	FLU3~SANOFI PASTEUR~U2763AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333365	11/26/2008	MI	1.6	1	.6	F	11/26/2008	Doctor believes injection was in bursa causing bursitis-severe pain in left shoulder				Y					U	10/21/2008			Arm X-ray	OTH	PVT		None	None			1						1	Bursitis; Musculoskeletal pain; Wrong technique in drug usage process; X-ray	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0333366	11/26/2008	VA	57.0	57		F	11/25/2008	Patient was asleep and became chilled and began shivering for about an hour.   Finally shaking stopped.									Y	11/08/2008	11/09/2008	1	None	OTH	PVT		None	Heart problem			1						1	Chills; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA366CA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0333368	11/26/2008	OH	30.0	30		F	11/26/2008	Pt describes fever, achiness, redness @ injection site lasting for 3 days. Has had influenza vaccine previously w/o any problems. She describes these s.e's as being severe.									Y	11/20/2008	11/20/2008	0	None	UNK	PUB	Unknown	None				1						1	Injection site erythema; No reaction on previous exposure to drug; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88113 1P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333370	11/26/2008	IL	48.0	48		F	11/26/2008	Patient telephoned the 1-866 number and requested a call back. She called on 11-25-08 and I called her that day.  She stated that since she had the flu vaccination she has had arm pain.  At first she said she thought it would go away and did not call us.  Yesterday, 11-25-08 was the first day she called to notify us.  She states she has gone to an orthopedic surgeon for an evaluation of the pain.  She states the physician found no broken bones and prescribed some Diclofenac for the pain.  She states that she has the pain and wants to know what to do.  She called our clinic to see what she should now do.									Y	10/23/2008	10/23/2008	0	Unknown	UNK	UNK		None stated				1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2806AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333372	11/26/2008	PA	57.0	57		M	11/26/2008	Phenytoin toxicity, also reported in VA ADERS. 12/29/2008 MR received for DOS 11/25-28/2008 with D/C DX:  Dilantin Toxicity.  Hx of seizure d/o. Pt presented to ER with c/o feeling unwell and tired x 1 wk as well as episodes of SOB.  Seen twice in ER previously. This am pt  was feeling hot/cold, dizzy, shakey and feeling as though would fall. Admitted for observation. On 11/26/08 pt developed substernal chest pain/pressure which resolved on it's own. EKG was WNL. On 11/27 pt developed twitching  of jaw. No new seizure activity.					Y	2			Y	11/12/2008	11/25/2008	13	phenytoin level 43.4 mcg/ml 13 days after vaccine; had been on the same phenytoin dose for over 5 years.   Labs and Diagnostics:  Dilantin level 43.3. EKG normal. CXR normal. CT brain (+) for encephalomalacic changes.	UNK	UNK	Active Outpatient Medications                          Status ========================================================================= 1)   ALBUTEROL 3/IPRATROP 0.5MG/3ML INHL 3ML INHALE 1 VIAL  ACTIVE        IN NEBULIZER BY MOUTH NOW 2)		PMH: Seizure d/o. Porokeratosis. Back pain. Obesity Hyperlipidemia. HTN			1						1	Drug level increased; Drug toxicity	FLUX~UNKNOWN MANUFACTURER~AFLLA184AA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0333373	11/26/2008	OK	43.0	43		F	11/26/2008	Five hours after vaccination, I began to have trouble breathing.  My voice got really horse and I felt that I was only able to take in about 60-70% of my normal air.  Then, I got extremely cold and couldn't get warm.  I got under covers and began shaking fiercly.  This went on for several hours and finally stopped after several sweats.									Y	11/25/2008	11/25/2008	0	None	PUB	UNK		None	None			1						1	Dysphonia; Dyspnoea; Feeling cold; Hyperhidrosis; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0333374	11/26/2008	NC	9.0	9		F	11/26/2008	Pt woke with faint red raised rash over her arms face and back which developed and included strong itching as the day progressed. Went to MD 11/25/2008 and received a prescription which relieved her symptoms.No reaction to previous  flu vaccine in 2006.									N	11/24/2008	11/25/2008	1	none	PUB	PUB	none	none	none			1						1	No reaction on previous exposure to drug; Rash; Rash erythematous; Rash papular; Rash pruritic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89973~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333377	11/26/2008	AZ	1.25	1	.3	M	11/26/2008	fever, constant crying (unconsolable), knot at injection site, injection site hot, not eating, not sleeping, drinking very little, and not wanting to walk or be picked up.  So far we are treating with an ice pack, ibuprofen, and TLC.  His symptoms normally last a month or longer before he returns to normal.  If symptoms persist he will be taken to the ER.									U	11/25/2008	11/25/2008	0		MIL	MIL						1						1	Abnormal behaviour; Anorexia; Crying; Fluid intake reduced; Injection site induration; Injection site warmth; Pyrexia; Sleep disorder	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B087CA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2833AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB1499AA~1~IM~LA~HEP A (HAVRIX)~1|PPV~PFIZER\WYETH~D05881~4~IM~RL~PNEUMO (PNU-IMUNE)~1	USA		Influenza
0333378	11/26/2008	CA	38.0	48		F	11/26/2008	LIGHT HEADEDNESS, DIZZINESS, DIAPHORERIC									Y	11/05/2008	11/05/2008	0	NONE.	PVT	PVT	SEROQUEL AND PHENOBARBITAL,	BACK PAIN, CHRONIC PTSD. MIGRANES, SCIATICA	ALLERGIES TO DEMEROL AND SULFA.			1						1	Dizziness; Hyperhidrosis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA192AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0333379	11/26/2008	IN				U	11/26/2008	within minutes of receiving vaccines became hot/flushed and developed hives over body and experienced swelling of tongue. Has history of severe allergic reactions ands carries treatment medications with her. She took benadryl, doxepin, and chlortrimeton. Symptoms resolved without taking epinephrine as well.			Y						Y	11/06/2008	11/06/2008	0		PVT	UNK	Doxepin, benadryl, chlortrimetron	None	Severe life threatening allergic reactions to PCN.			1						1	Feeling hot; Flushing; Swollen tongue; Urticaria	FLU3~SANOFI PASTEUR~U2791BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~UF455AA~1~IM~RA~TDAP (ADACEL)~1	USA	Life Threatening	Influenza
0333380	11/26/2008	OH	63.0	63		M	11/26/2008	Patient states he had muscle aches, fever, weakness and difficulty breathing 3-4 hours after the shot. Did not seek medical attention. States he went to bed and woke up during the night with vomiting and diarrhea which lasted 7 days.  Finally saw family doctor who told him he had allergic reaction to flu shot				Y					Y	10/22/2008	10/22/2008	0	none	PUB	PVT	Zithromax given AFTER vaccine administration --- to treat the diarrhea	none	Allergic to XRay dye and SOMA--Has heart stent and kidney stones		102	1						1	Asthenia; Diarrhoea; Dyspnoea; Hypersensitivity; Myalgia; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2768AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333381	11/26/2008	AZ	61.0	61		M	11/26/2008	Experienced an intense flu cycle, 4.5 hours after vaccination. Onset of bone-racking chills at 8:00 PM, 11/25/08, lasting for 2 hours, then uncontrollable projectile vomiting, then fever (slight at first) which built up until it broke at 3:15AM, 11/26/08.  Bundled in blankets for chills, took Tylenol Rapid Action liquid for fever, and applied ice packs to forehead, back of neck and chest.  Took ice chips by mouth from 11PM, 11/25/08 until 3AM, 11/26/08.  Slept from 3:15 - 6:20 and woke up feeling weak, but certainly better.									Y	11/25/2008	11/25/2008	0		PUB	UNK	none	none . . . although there is a lot of stomach flu going around... and my post-vaccination reaction may be merely coincidental  (I may have just caught something else)	none	Intense Flu symptoms~Influenza (Seasonal) (Fluzone)~NULL~61.90~In Patient		1						1	Asthenia; Chills; Influenza; Pyrexia; Vomiting projectile	FLU3~SANOFI PASTEUR~U2809AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333383	11/26/2008	NJ	13.0	13		F	11/26/2008	Child got slight fever on 11/21/08. Then on 11/23/08, got dizzy & fell down on the kitchen floor,no LOC. Is ok now.									U	11/19/2008	11/21/2008	2	None	PVT	PUB	none					1						1	Dizziness; Fall; Pyrexia	FLU3~SANOFI PASTEUR~U2797DA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0229 X~1~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0333385	11/26/2008	TX	47.0	47		M	11/26/2008	shoulder begin to ache, by evening site was swollen to size of grapefruit and hard and hot to the touch.  At 6:00p.m, got very congested and started coughing alot,hard to breathe,(the hard to breathe part subsided after a few seconds) felt weak, tired, and could feel pain all the way to my fingertips.  felt mild nausea and headache that lasted for three and a half days.  Took nyquil two nights in a row and by Friday morning felt better but only worked half day. Did not feel completely back to normal until Sunday afternoon except for the soreness still around the site of the shot.									Y	11/19/2008	11/19/2008	0	but spot where shot given is still sore	UNK	PVT	occasional allergy medicine but none the day of shot	no, and I have gotten the flu shot for 6 years now with no problems	allergy to shellfish and oregano and environmental allergies.  Have had reactive airways in the past when I have been sick.	none~ ()~NULL~~In Patient		1						1	Activities of daily living impaired; Asthenia; Cough; Dyspnoea; Fatigue; Headache; Injection site induration; Injection site pain; Injection site swelling; Injection site warmth; Nausea; Respiratory tract congestion	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0333386	11/26/2008	MS	4.0	4		F	11/13/2008	Pt presented to HD in no acute distress 11/13. Shots given 11/10/08. Mother states child was taken to ER 11/12. Received steroid shot for allergic reaction, erythematous area 9-10 cm in child's  Dr. prescribed amoxcillin.				Y					Y	11/10/2008	11/12/2008	2		UNK	UNK		None Known	None Know		MS112008	1						1	Erythema; Hypersensitivity	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B08588A~5~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2828AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0492~4~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1081X~2~IM~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0333391	11/26/2008	FL	67.0	67		F	11/26/2008	Headaches, weakness, sore arm, generalized hives, severe urticaria and fatigue, difficulty swallowing, marked facial edema. 12/17/2008 MR received for ER 10/26/08 and admit 10/27-11/1/2008 with D/C DX: Acute Allergic Reaction with diffuse, severe urticaria and angioedema-felt to be 2' to recent vaccination.  Minimal liver enzyme elevation-felt to be 2' to allergic rxn. Pt initially presented to ER 10/26/08 with urticaria and lip swelling. Tx with steroid and antihistimines with 80% improvement. Returned the next day with worsening urticaria, generalized erythema/rash, and swollen lips, face and eyelids. Readmitted for more IV steroids with 90% improvement.				Y	Y	6			N	10/22/2008	10/23/2008	1	Elevated blood glucose, elevated liver function tests, elevated WBC.Labs and Diagnostics: CXR WNL. CBC with WBCs up to 20.8. AST 108. ALT 174.	UNK	UNK	Daily Vit. C., Ocuvite, Fish Oil, Folic Acid		Oxybenzene (sunscreen lotions). PMH: cholecystectomy			1						1	Asthenia; Blood glucose increased; Dysphagia; Face oedema; Fatigue; Headache; Pain in extremity; Swelling face; Urticaria; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~2772R (?)~3~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~13624 (?)~UNK~IM~LA~PNEUMO (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0333392	11/26/2008	CA	46.0	46		F	11/26/2008	1) Arm muscle soreness at injection site & generalized fatigue for 2-3 days after vaccine; 2) REASON FOR THIS REPORT: then onset 1 week after vaccine of severe spinal pain radiating down both legs, severe headache, low grade fever, night sweat X 1 night, chills & fatigue progressively worsening over 3 days with no known exposure to meningitis or any other viral illness. Symptoms peaked in severity from 11/13pm-11/14pm and relieved after acupuncture and several days of ibuprofen and rest.				Y					Y	11/05/2008	11/11/2008	6	n/a	PVT	UNK	vivelle patch 0.05mg	none	none			1						1	Bone pain; Chills; Fatigue; Headache; Injection site pain; Night sweats; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88113 4p~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0333424	11/26/2008		49.0	49		M	11/28/2008	We received from a health care professional via the Medical Communication the following information on 16 OCT 2008: A 49-year-old man, born on 26 FEB 1959, was vaccinated with 0.5 ml FLUVIRIN, batch-no. 89881, i.m. on 04 OCT 2008. On 13 OCT 2008 the patient began to experience pain between his shoulders, with pain progressing throughout the body, he developed a low grade fever, and became lethargic and confused. The patient was transported to the emergency room, where he was started on vancomycin, rocephin, and acyclovir for possible meningeal encephalitis. Patient was admitted to the hospital on 14 OCT 2008. On 15 OCT 2008 a lumbar puncture revealed the following: first 4 ml tube showed cerebral spinal fluid clear and colorless, no white blood cells, no red blood cells, and the second tube showed cerebral spinal fluid protein 40 (high), red blood cells 40 (high), protein 86 (high), and glucose 84 (within normal limits). Review of manufacturing protocols demonstrated that there were no deviations affecting product. No change in assessment. We received from the reporting health care professional the following information on 30 OCT 2008: The patient was discharged on 20 OCT 2008. No change in assessment. We received additional information from a physician on 17 NOV 2008: The patient recovered from meningoencephalitis symptoms completely in 5-6 days. Due to HIPAA rules, the physician is unable to send the hospital report. No change in assessment. We received the hospital report on 24 NOV 2008: The patient was admitted after having a flu-like illness for approximately one to two days prior to admission. On presentation to the emergency department, the patient was obtunded with complaint of generalised body aches and neck stiffness. He had a waxing and waning mental sensorium and was therefore admitted for neurological evaluation and monitoring. CNS cultures remained no growth. Viral serologies remained negative. CT scan was performed, which did not show any abnormal enhancing masses, midline shift or intracranial hemorrhages that could explain the patient's presenting symptoms. The EEG showed diffuse semi-rhythmic delta and persistent background slowing consistent with a mild to moderate encephalopathy. There were no epileptiform discharges or patterns noted on his EEG. The patient was continued on antibiotic therapy and steroids and Keppra were added per neurology for concerns for possible seizure. Serologies for West Nile, HIV and HSV were also negative. By hospital day number three, the patient's mental sensorium had improved significantly. He was oriented times three and voiced complaints of headaches, which were treated symptomatically. By the patient's fourth day of hospitalisation, he had returned to his baseline mental status and was ambulating without difficulty. While the patient's labs, imaging and serology testing remained negative, it was felt that his condition was most consistent with a viral encephalitis. There was some concern that presentation could have been post-flu vaccine related as the patient had received a flu vaccination approximately eight days prior to the onset of symptoms. At the time of discharge, the patient was in his usual state of health with baseline mental status. He is discharged home in good condition. Current anxiety and depression, in history testicular cancer and deep venous thrombosis.					Y	6			Y	10/04/2008	10/13/2008	9		OTH	OTH	No other medications	Anxiety/depression	Testicular cancer; Deep venous thrombosis.		MA20082400	1						1	Back pain; CSF glucose normal; CSF protein increased; CSF white blood cell count negative; Computerised tomogram normal; Confusional state; Depressed level of consciousness; Electroencephalogram abnormal; Encephalitis; HIV test negative; Headache; Herpes simplex serology negative; Influenza like illness; Lethargy; Lumbar puncture; Musculoskeletal stiffness; Pain; Pyrexia; Red blood cells CSF positive; Virus serology test negative	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0333436	11/26/2008	CA	1.29	1	.3	M	11/26/2008	Fever 104. ER trip.									N	11/21/2008	11/21/2008	0	None	PVT	PVT	None	None	FTT			1						1	Pyrexia	FLU3~SANOFI PASTEUR~UTZ782CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333439	11/26/2008	NM	7.0	7		M	11/21/2008	Patient was seen for his 7 year old physical. He had a history of obstructive sleep apnea, but was getting better. Flumist was given at that time 11/4/08. Since 11/4/08- patient had onset of prolonged congestion, restart of snoring and reemergence of sleep apnea.				Y					U	11/04/2008	11/04/2008	0	None	PVT	PUB		None	Resolved obstructive sleep apnea.			1						1	Condition aggravated; Respiratory tract congestion; Sleep apnoea syndrome; Snoring	FLUN3~MEDIMMUNE VACCINES, INC.~500560P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0333440	11/26/2008	MA	36.0	36		M	11/26/2008	Clinic visit on 11/14/08 - Left sided chest pain since 11/11 with some radiation to left arm associated with diaphoresis and elevated BP, light headache and difficulty taking deep breath. Chest pain worse on morning of 11/13/08. Pain was worse when lying flat, cough, or deep breath. Not associated with exertion. Nonprandial. Given MOTRIN at local clinic with little relief. After enzymes (+) on 11/14/08, pt referred on 11/18/08 to hospital and admitted overnight. Discharged the following day. Since this episode, he has developed cold-like symptoms (runny nose, cough), but his chest pain has been absent. Performs ADLs w/o development of chest pain, sob, or tightness.  12/5/08 Reviewed hospital medical records of 11/18-11/19/2008. FINAL DX:noncardiac chest pain; asthma; tobacco use disorder. Records reveal patient experienced left side chest pain w/radiation down left arm x 1 week, constant x 3 days then intermittent.  Evaluated at outside clinic where troponin reported to be 0.97(H).  Cardiac w/u neg.  D/C to home w/PCP f/u.					Y	1			Y	10/31/2008	11/11/2008	11	11/14/08, CRP u/s 27.0; Chol, 127; Trig 103; HDL, 35; LDL, 77; Creatine Kinase MB, 0%; Creatine Kinase, 87 U/L; Troponin I Cardiac, 0.97 (H*) ng/mL; 11/14/08, Reported normal ECG; 11/19/08, TTE: EF 55%, Normal; GXT - NL GXT exercise echo w/o exercised induced segmental wall motion abnormalities to suggest stress induced myocardial ischemia at 94% of predicted MHR for age. Note: Post exercise images are suboptimal secondary to pt imaging characteristics. 11/26/08, ECHO - showed normal LV function with no e/o pericardial effusion  LABS: cardiac enzymes neg, troponin 0.03.  CBC, chemistry, EKG, CXR, echocardiogram, stress test WNL.	MIL	MIL	None	None	Hx of heart murmur  PMH: Osgood-Schlatter disease.  Heart murmur.  Smoker.  Allergy: iodine, anaphylaxis, percocet, stomach upset.  Family hx: premature CAD, MI, Marfan's.			1						1	Blood cholesterol normal; Blood creatine phosphokinase MB; Blood creatine phosphokinase normal; Blood pressure increased; Blood triglycerides normal; C-reactive protein increased; Cough; Dyspnoea; Echocardiogram normal; Ejection fraction normal; Electrocardiogram normal; Exercise test normal; Headache; High density lipoprotein normal; Hyperhidrosis; Low density lipoprotein normal; Nasopharyngitis; Rhinorrhoea; Troponin I increased	ANTH~UNKNOWN MANUFACTURER~~UNK~SC~UN~ANTHRAX (NO BRAND NAME)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~A14ABB103A~UNK~UN~UN~HEP A + HEP B (TWINRIX)~1|SMALL~EMERGENT BIOSOLUTIONS~~UNK~~UN~SMALLPOX (ACAM2000)~1|TYP~SANOFI PASTEUR~A09233~UNK~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Hospitalisation	Influenza
0333443	11/26/2008	RI	42.0	42		F	11/28/2008	Guillain-Barre, numbness started hands and feet 10-20-08. Seen 10-27-08 for same progressed with ascending numbness and weakness and back pain. Hospitalized in ICU for one week. Mostly better now.  12/11/08 Received hospital records of 11/06/11/13/2008 FINAL DX: ascending polyneuropathy secondary to GBS Records reveal patient experienced numbness of both feet 6 days s/p vaccine which progressed to her hands,  feet heaviness & balance difficulties.  Symptoms did not improve & admitted.  Neuro consult done.  Tx w/IVIG x 5 days.  Improved & d/c to home for outpatient PT & neuro f/u.  2/11/09 Received hospital Neuro consult & hospital labs. Neuro consult indicates pt had begun outpatient w/u w/neurosurg which was WNL.  Had been referred to neuro but fell in MD office several times & was admitted to hosp w/o EMG/NCS being done.  Neuro exam in hosp revealed decreased reflexes & decreased sensation.  LP done but no EMG/NCS while in hospital due to equipment difficulty.  Tx w/IVIG.  EMG/NCS scheduled as outpatient & has been requested.  2/17/09 Received Neuro consult, EMG/NCS & CSF studies. FINAL DX: polyneuropathy Records indicate patient experienced numbness & tingling of hands/feet, unsteady gait.  Fell several times in MD office & admitted to hospital.  Exam revealed decreased reflexes of LEs.					Y	7			Y	10/07/2008	10/20/2008	13	LABS: CBC 7 chemistry WNL except for Sodium 129(L) & WBC 1.7(L) after IVIG.  MRI brain & spine WNL.  CT brain WNL.  EMG/NCS abnormal & c/w sensorimotor axonal polyneuropathy.  Chloride 97(L), anion gap 3(L), BUN 24(H), AST 44(H), free T41.20(H).  UA (+)leuk esterase, c/s contaminated. CSF: glucose 64(N), protein 187(H), RBC 19(H), c/s neg.	PVT	PUB	None	None	None  PMH: low back pain; bulging lumbar disc; obesity.			1						1	Asthenia; Back pain; Guillain-Barre syndrome; Hypoaesthesia; Intensive care	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~84996~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0333444	11/26/2008	PA	69.0	69		M	11/29/2008	Possible brain aneurysm. 12/15/2008 MR received for DOS 11/25-12/03/2008 with Dx:  Subarachnoid hemorrhage.  Abnormal electrocardiogram probably related to intracranial abnormalities. . Pt presented with 7 day hx of severe h/a which began following flu shot with stiff neck. Seen at local facility where CT scan was concerning for R temporal and R parietal subarachnoid hemorrhage. Transferred to current facility for mgmt. PE (+) for disconjugate gaze. Pt spent several days in ICU then regylar floor with slow resolution of h/a and no further development of any other sx. D/C to care of family  and for outpt f/u.			Y		Y	7			Y	11/19/2008	11/19/2008	0	MRI; Angiogram. Labs and Diagnostics: EKG abnormal.  BUN 30. CT angio of head abnormal.  Transcranial duplex with non-visulaization of L sided vessels.  Head CT (+) for sub arach hemorrhage. MRA head (+) for subarach hem.  MRI cervical spine (+) for disc bulges and stenosis. Cerebral angio (+) for vasospasm of the MCA.	PUB	PVT	None	None	None. PMH: L eye blindness due to retinal detachment. hernia with repair.  fx arm. NKDA.			1						1	Angiogram; Nuclear magnetic resonance imaging	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA381BA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Life Threatening,Hospitalisation	Influenza
0333445	11/26/2008	CA	39.0	39		M	11/30/2008	Patient came back the day after vaccination with a swolen uvula-had difficulty swallowing.  Took BENADRLY OTC which helped.									Y	10/17/2008	10/18/2008	1		OTH	PVT	Started LORAZEPAM on same day as vaccination	None				1						1	Dysphagia; Enlarged uvula	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333446	11/26/2008	MO	83.0	83		M	11/30/2008	pain occurred approx 1 week post injection.  Constant pain									N	10/07/2008	10/14/2008	7	None	OTH	PUB		No	Pt's did not report			1						1	Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333447	11/26/2008	MO	78.0	78		F	11/30/2008	Pain occurred approx. 1 week post injection. Started intermittently, now constant pain.									N	10/07/2008	10/14/2008	7		OTH	PUB						1						1	Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333452	11/26/2008	MO	67.0	67		F	11/26/2008	Client states has had pain to L arm since injection.  States has achiness to L arm at injection site and up into her shoulder.  (Injection was 10-6-08)										10/06/2008	10/06/2008	0		PUB	PUB						1						1	Injection site pain; Musculoskeletal pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2743AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333454	11/26/2008	NJ	10.0	10		F	11/24/2008	Patient developed red puffy eyes, which were itchy. No wheezing, no respiratory difficulties.				Y					Y	11/19/2008	11/20/2008	1	None	PVT	PUB	TEGRETOL	None	Seizure disorder			1						1	Eye pruritus; Eye swelling; Ocular hyperaemia	FLUN3~MEDIMMUNE VACCINES, INC.~500561P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0333456	11/26/2008	CA	53.0	53		M	11/26/2008	Pt has localized pain at site of injection, had vomiting, and fever.  He is unable to move arm.									U	11/25/2008	11/25/2008	0		OTH	PUB	None	None				1						1	Akinesia; Injection site pain; Pyrexia; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~13839~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0333457	11/26/2008	OR	38.0	38		F	11/26/2008	possible pierce of ulnar nerve				Y					U	11/07/2008	11/08/2008	1		OTH	PVT		None	None			1						1	Ulnar nerve injury	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA183AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0333458	11/26/2008	FL	46.0	46		F	11/24/2008	Continuing pain at the site (where administered). To raise right arm is very painful.									N	11/13/2008	11/14/2008	1		OTH	PVT	None	None	None			1						1	Injected limb mobility decreased; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~87950~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333049	11/28/2008	TX	18.0	18		F		3:15pm IM injection, 5 minutes later patient reported blurred vision and feeling strange. Had patient. Sit down. Reported feeling warm and nauseous. She ask for water, gave bottle, drank a little. Did not feel any better. Did not have breathing difficulty or swallowing 3:30pm reported she was having hearing difficulty and could not see. 345 reported difficulty hearing things. Administered EPT, call 911 EMT arrived in 10 min took her to hosp ER.				Y					Y	11/21/2008	11/21/2008	0		UNK	UNK						1						2	Feeling abnormal; Feeling hot; Hypoacusis; Immediate post-injection reaction; Nausea; Vision blurred; Blindness transient; Feeling abnormal; Feeling hot; Hearing impaired; Nausea; Vision blurred	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881131P~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881131P~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0333399	11/28/2008	MO	49.0	49		F	11/28/2008	Rash on upper arm. Blotchy, doesn't itch, warm to touch, no drainage, not raised. On the inner aspect of arm				Y					Y	11/07/2008	11/08/2008	1		UNK	PVT						1						1	Rash macular; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89966~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0868X~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0333400	11/28/2008	MO	30.0	30		F	11/28/2008	mild swelling of lower arm, wrist, and hand									Y	11/04/2008	11/04/2008	0		UNK	PVT						1						1	Joint swelling; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89966~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333404	11/28/2008	MN	57.0	57		F	11/28/2008	Symptoms: (have now persisted for over a month since the vaccination on Oct. 22, 2008). Include: deep aching in left upper arm, radiating into shoulder, especially when arm is at rest, such as when reading or driving; pain into left side of neck and chest (mimicks angina); difficulty placing left arm into coat sleeve due to decrease range of motion in left shoulder; no significant relief of discomfort after using Aleve, Ibuprofen or Ben Gay										10/22/2008	10/23/2008	1		UNK	UNK	Depakote for migraines; Cymbalta; Imitrex prn	none. For lack of another place to note this...I had a discussion with my mother yesterday, who had her flu shot about the same time as me. She has had EXACTLY the same symptoms to me. Every single symptom were the same for each of us.	nickel allergy			1						1	Chest pain; Injection site pain; Joint range of motion decreased; Neck pain	FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0333415	11/28/2008	TX	46.0	46		F	11/28/2008	Patient called 11-28-08 and said her arm was still sore from vaccine. Pain is like that of a sore muscle.									N	10/31/2008	10/31/2008	0		OTH	UNK						1						1	Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8999Y~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333418	11/28/2008	MA	44.0	44		F	11/28/2008	Throat and tongue swelling, hives, SOB anaphylaxis.				Y					Y	11/26/2008	11/26/2008	0	None	PVT	PUB	None	None	Allergy sulfa, Doxycycline, Asthma			1						1	Anaphylactic reaction; Dyspnoea; Pharyngeal oedema; Swollen tongue; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89996~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0333419	11/28/2008	WA	2.0	2	.9	M	11/26/2008	Sudden onset of facial and oral edema around 2pm after eating pizza and pineapple. Had received influenza injection about 5 hours earlier. Symptoms improved with SQ Epinephrine.				Y					Y	11/26/2008	11/26/2008	0		PVT	PUB	Ibuprofen; Delsym	Viral URI	Penicillin allergy			1						1	Face oedema; Oedema mouth	FLU3~SANOFI PASTEUR~UT2785DA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333420	11/28/2008	TN	61.0	61		F	11/28/2008	Nausea, vomiting x1 episode, heart racing. Symptoms started about 3-4 hours after vaccine. Advised to take 25mg of BENADRYL, about 4-5 hours after vaccine. 8-10 hours after vaccine, all symptoms resolved. Patient thought BENADRYL may have caused vomiting.										10/22/2008	10/28/2008	6		OTH	UNK						1						1	Nausea; Palpitations; Vomiting	FLU3~SANOFI PASTEUR~U2803~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333423	11/28/2008	MI	43.0	43		F		Vaccine given @ approx. 2pm @ approx 6pm. Rt knee starting hurting then about 12:30 AM severe itching started @ neck and head. Rt hand and eyes swollen. Employee event to clinic @ 12pm on 11/19/2008, given Benadryl injection.				Y					Y	11/18/2008	11/18/2008	0		OTH	OTH	Sinus medication Thursday run	Sinus pressure				1						1	Arthralgia; Eye swelling; Oedema peripheral; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA209AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0333461	11/28/2008	OH	40.0	40		F	11/26/2008	Complain of rash on legs, stomach, and under arms. Small red bumps. itchy. Lump and pain at injection site.									U	11/24/2008	11/25/2008	1		PVT	PVT						1						1	Injection site mass; Injection site pain; Rash erythematous; Rash pruritic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8803902~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333405	11/29/2008	IL	61.0	61		F	11/29/2008	PATIENT STATED SHE HAS DEVELOPED A RASH WITH HIVES ON HER HANDS									U	11/25/2008	11/27/2008	2		UNK	PUB		N/A				1						1	Rash; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~892973P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333406	11/29/2008	IN	65.0	65		F	11/29/2008	Felt like lump in throat, swelling of throat and difficult to breath.  Treatment: Benadryl									Y	11/28/2008	11/28/2008	0		UNK	PUB	none	none	Tetracycline			1						1	Dyspnoea; Pharyngeal oedema; Sensation of foreign body	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0333408	11/29/2008	VA	10.0	10		F	11/29/2008	My daughter got the flu shot. She is a type 1 diabetic the nurse gave her the shot in the fat  and not the muscle she swelled up right after. she has a welt the size of a apple red hard and very painful. It is sat the clinic is closed but i may bring her in to ergent care.				Y					U	11/28/2008	11/28/2008	0		PVT	UNK	insulin, novalog,lantus,adderall	cough for a few weeks.	type 1 diabetic. adhd. ocd.			1						1	Induration; Pain; Swelling; Urticaria; Wrong technique in drug usage process	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0333409	11/29/2008	PA		45		F	11/29/2008	I have experienced continued achiness in upper arm where the flu shot was administered.  Most noticeable when arm is elevated to shoulder height.  This feeling has been on-going since the date the vaccine was given.									N	10/23/2008	10/23/2008	0		PUB	PVT	Levoxyl	N/A	none			1						1	Arthralgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0333412	11/30/2008	FL	35.0	35		F	11/30/2008	Patient is a Registered Nurse. About 30 min after receiving vaccine patient began to have pressure on upper sternum and squeezing in throat. She reports, I could only breathe if I hyperextended my neck. My husband gave me 50 mg Benedryl after 10 minutes. The sensation resolved after about 45 minutes.									Y	11/19/2008	11/19/2008	0	N/A	PUB	PVT	NONE	none	erythromycin and azithromycin	none~ ()~NULL~~In Patient|none~ ()~NULL~~In Sibling1		1						1	Chest discomfort; Drug hypersensitivity; Dyspnoea; Throat tightness	FLU3~SANOFI PASTEUR~u2898fa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333413	11/30/2008	WI	3.0	3		F	11/30/2008	Hives were found on left flank, left elbow and bilateral thighs approximately eight hours after administration.  We are not sure of when exactly the hives appeared as they did not seem to bother her.  Benadryl was given every 6 hours for the next 5 days since the hives would return.									Y	10/27/2008	10/27/2008	0	none	PVT	PVT	none	none	global developmental delay			1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~unknown~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0333448	11/30/2008	GA	42.0	42		F	11/30/2008	Swelling of shot area. Tingling from area down to fingers, feels like pins and needles, can't raise arm (left), hurts around to my shoulder blade.									N	11/28/2008	11/28/2008	0	Negative	OTH	PVT						1						1	Injected limb mobility decreased; Injection site swelling; Musculoskeletal pain; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~2~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332668	12/01/2008	MS	40.0	40		F	11/20/2008	Diagnosed & admitted to hospital with ITP. Hospitalized from 11/06/08 till 11/16/08. Massive blood loss, areas of bruising over entire body.			Y		Y	11	Y		Y	10/17/2008	10/31/2008	14	Platelet count went as low as 2,000	UNK	UNK	EFFEXOR 37.5 mgs every morning	None	None			1						2	Idiopathic thrombocytopenic purpura; Contusion; Haemorrhage; Idiopathic thrombocytopenic purpura; Platelet count decreased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89989~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89989~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Life Threatening,Hospitalisation	Influenza
0333002	12/01/2008	FL	46.0	46		F	11/26/2008	Seriousness Criteria: Other-Medically Significant. Initial report received from a pharmacist on 20 November 2008. A 46-year-old female patient had received a dose of FLUZONE SV 2008-2009 (lot number rU2764AA, route and site of administration not reported) on 13 November 2008 and 1.5 hours later, she had a reaction with the following symptoms: pain in throat, chest tightness, shortness of breath, wheezing, dry cough and bronchospasm. At that time, she received treatment with albuterol. The patient then continued to have more reactions-red itchy eyes, yellow/green discharge from the eyes, blurred vision and runny nose. The patient then received treatment with CLARITIN, prednisone and BENADRYL. Symptoms lasted for 1.5 to 3 hours and the patient recovered. At the time of the vaccination, the patient was taking concomitant medications BACTRIM and FLONASE, however, indications were not reported. Documents held by sender: None				Y					Y	11/13/2008	11/13/2008	0		PUB	UNK	BACTRIM; FLONASE		The patient had no known allergies. The patient was taking BACTRIM and FLONASE at the time of vaccination; however, pre-existing medical conditions and illnesses at the time of vaccination were reported to be unknown. The patient had received several previous doses of FLUZONE.		200803692	1						2	Chest discomfort; Cough; Dyspnoea; Eye discharge; Eye irritation; Eye pruritus; Eyelid oedema; Headache; Nasal congestion; Ocular hyperaemia; Throat irritation; Wheezing; Bronchospasm; Chest discomfort; Cough; Dyspnoea; Eye discharge; Eye pruritus; Ocular hyperaemia; Oropharyngeal pain; Rhinorrhoea; Vision blurred; Wheezing	FLU3~SANOFI PASTEUR~U2764AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2764A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0333414	12/01/2008	MI	40.0	40		F	11/30/2008	Developed case of painful shingles on right side of trunk/back.  Itching and tingling started 2 days after shot, along with weakness and fatigue.  Full-blown shingles a week after the flu shot.  Oral steroid (prenisone) was taken for 10 days with not much success.  Pain and sensitivity continued for 1 month, and symptoms have just subsided in the past couple days.  This link between shingles and flu vaccine really needs to be explored - just look at this website to see stories of people THIS YEAR that have had shingles after flu vaccine: Guillian-Barre syndrome is a rare side effect of flu vaccine.  Guess what a complication of shingles is?  Guillian-Barre syndrome.  They are both inflammations of nerves.  There is a link, and people need to be made aware of this potential side effect.  I hope some studies are being done about shingles and flu vaccine.  This has been a horrible month of my life and I will not get the flu shot ever again.				Y					Y	10/28/2008	10/30/2008	2	Shingles culture was taken by doctor, sent to lab, and was positive for zoster virus.	UNK	UNK	Daily multivitamin, calcium supplement	none, and I wasn't run down or under stress either (common causes of shingles).  I am a very healthy 40 year old.	allergic to amoxicillin			1						1	Asthenia; Fatigue; Herpes zoster; Pain; Paraesthesia; Pruritus; Virus culture positive	FLUX~UNKNOWN MANUFACTURER~unknown~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0333472	12/01/2008	PA	45.0	45		M	11/26/2008	Initial report received on 20 November 2008 from a physician. A 45-year-old male patient, with no concurrent illnesses, and a history of heartburn, had received a first deltoid injection of FLUZONE SV 2008-2009 (lot number U27751AA, not a valid Sanofi Pasteur lot number) on 06 November 2008 at 16:00 pm. Approximately nine or 10 ten days (also reported as nine days) after receiving the FLUZONE, the patient experienced numbness around the right side of his mouth. Approximately two days later, the patient was evaluated by his physician and diagnosed with Bell's palsy. The patient was treated with Prednisone and Famciclovir. Blood work was drawn and a magnetic resonance imaging (MRI) of the brain was ordered; however the dates of service and results of both  tests were not provided. At the time of this report, the recovery status of the patient was unknown. Documents held by sender: None				Y					U	11/06/2008	11/16/2008	10	Blood work was drawn and an magnetic resonance imaging (MRI) of the brain was ordered; however the results of both tests were not provided.	OTH	OTH			The patient had no concurrent illnesses, but did have a history of heartburn at the time of vaccination on 06 November 2008.		200803691	1						1	Blood test; Facial palsy; Hypoaesthesia oral; Nuclear magnetic resonance imaging brain; Blood test; Facial palsy; Hypoaesthesia oral; Nuclear magnetic resonance imaging brain	FLU3~SANOFI PASTEUR~U27751AA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U27751AA~1~UN~AR~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0333474	12/01/2008	MA				F	11/26/2008	Initial report received on 21 November 2008 from a Nurse Practitioner.   A female patient (demographics not provided), who had no concurrent illnesses, and unknown past medical history, had received an intramuscular left deltoid injection of FLUZONE SV 2008-2009 (lot number U2840AA) on 17 November 2008.  Approximately five hours post-vaccination, the patient experienced shortness of breath, cough, congestion in her lungs, and her eyes became red, swollen and watery, similar to conjunctivitis.  Later that evening, the patient reported having generalized body aches and soreness, and she felt very tired.  The patient was not medically evaluated.  No relevant diagnostic tests or laboratory data were collected.  The following morning, all of the patient's symptoms had cleared.  Documents held by sender: None.				Y					Y	11/17/2008	11/17/2008	0	None	PUB	PUB			The patient  had no concurrent illnesses at the time of vaccination on 17 November 2008.  It was unknown if the patient had any pre-existing medical conditions, or use of other medications. The patient's had not experienced any adverse events with prior vaccinations, and had not received any other vaccinations within four weeks of 17 November 2008.		200803703	1						1	Cough; Dyspnoea; Eye swelling; Fatigue; Lacrimation increased; Ocular hyperaemia; Pain; Pulmonary congestion	FLU3~SANOFI PASTEUR~U2840A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333476	12/01/2008					F	11/26/2008	Initial report received from another manufacturer on 21 November 2008 who received the information from a consumer. An anonymous female patient (age not reported) received a flu vaccine (trade name, manufacturer, lot number not reported) two years in a row in the right arm. This year she noticed a lump on her arm in the same spot the vaccines were given and she had the lump removed. The patient had just learned that the lump was a squamous cell canceroma. No further information was provided. Documents held by sender: None.				Y					U				Not reported	UNK	UNK			Not reported		200803709	1						1	Injection site mass; Mass excision; Squamous cell carcinoma	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0333477	12/01/2008					M	11/26/2008	Initial report received on 21 November 2008 from an other manufacturer, who had received the original report from a consumer.  A male patient (demographics not provided) had received an influenza vaccine (trade name, manufacturer name, lot number, route and site of administration not provided) years ago on an unspecified date.  Per the reporter, at an unspecified amount of time later, the patient experienced Guillain Barre syndrome.  Treatments received, and diagnostic test performed were not provided.  Recovery status of the patient was not provided.  No contact information for follow-up was provided.  No further information is expected.  Documents held by sender: None				Y					U				Not reported	OTH	OTH			Not reported		200803712	1						1	Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0333481	12/01/2008	CA	21.0	21		F	12/01/2008	I TOOK THE SHOT MONDAY 11/17/08 AT ABOUT 11:23AM WHEN I GO HOME I FELT REAL TIRED AND WEAK. A COUPLE OF HOURS LATER I HAD HEADACHES, CHILLS AND FEVER ALL I DID WAS REST AND SLEEP IN ALL DAY.I WAS NOT ABLE TO GO IN TO WORK THAT DAY. THE NEXT DAY TUESDAY 11/18 I STILL FELT THE SAME BUT STILL WENT IN TO WORK. THAT NIGHT ABOUT MIDNIGHT I FELT REAL ITCHY I HAD ACHES ALL OVER MY BODY. ON MY ARMS, HANDS, LEGS AND STOMACH THIS WENT ON AND OFF FOR ABOUT FOUR DAYS. IT WAS WORST IN THE EVENING AND AT NIGHT I WAS NOT ABLE TO SLEEP DUE TOT HE ITCHINESS UNTIL I WENT BACK IN TO MINUTE. THE REAL NICE NURSE THAT WAS THERE THAT DAY TOLD ME TO TAKE ZYRTEX AND USE AN OATMEAL SCRUB TO TRY AND STOP THE ITCHING. I DID NOT GO IN TO WORK FOR THE REST OF THE WEEK DUE TO HOW I FEELING. THE HEADACHES, CHILLS TIREDNESS, WEAK AND THE WORST THE ITCHINESS. I STARTED FEELING BETTER FORM THOSE SYMPTOMS AFTER I TOOK THE ZYRTEX.									Y	11/17/2008	11/18/2008	1		UNK	UNK	N/A	COUGH.	N/A			1						1	Activities of daily living impaired; Asthenia; Chills; Fatigue; Headache; Insomnia; Pain; Pruritus; Pyrexia; Somnolence	FLUX~UNKNOWN MANUFACTURER~AFLLA166AA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0333483	12/01/2008	MI	8.0	8		F	12/01/2008	Vaccine administered on 11/26/08 on 11/30 pt develeped mild malaise, low grade fever, rash with 9-12 spots on trunk, chest and head.  Rash itches.									U	11/26/2008	11/30/2008	4		PVT	PVT		NONE				1						1	Malaise; Pyrexia; Rash; Rash pruritic	FLU3~SANOFI PASTEUR~U2741AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0737X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0333487	12/01/2008	WI	17.0	17		F	12/01/2008	About 1 minute following administration of all three vaccines, client stated that she was going to pass out.  Eyes rolled back into head, exhibited decorticate posturing of right arm and leg, deep raspy breathing, and some tremors of legs.  Episode lasted approximately 10-15 sec.  Client startled and appeared scared and unable to recognize parents immediatly following episode.  Supportive and reassuring measures provided.				Y					Y	12/01/2008	12/01/2008	0	psychiatric history, on psych meds. for mood disorder	PUB	PUB	lamictal, other psych meds	getting over common cold				1						1	Dizziness; Gaze palsy; Hyperventilation; Memory impairment; Posturing; Tremor	FLU3~SANOFI PASTEUR~U2800EA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0575X~1~IM~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2812AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0333489	12/01/2008	GA	39.0	39		F	12/01/2008	patient stated she got infection at injection site.  she went to urgent clinic and received antibiotic and pain med.  is OK now				Y					Y	10/08/2008				UNK	UNK						1						1	Injection site infection; Injection site infection; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aklla176a~2~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0555u~2~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AGLLA176AA~2~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~2|PPV~MERCK & CO. INC.~0555U~2~UN~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0333490	12/01/2008	OR	45.0	45		F	12/01/2008	Sore right arm after the injection.  At night had a fever of 100.7 with shaking.  Had fever next day.  Two days post injection had red rash around injection site on right arm that was sensitive to touch.  Patient called ER and was advised to call clinic to report reaction.  Patient reported 6 days post injection and patient no longer had symptoms.  No further treatment needed.									Y	11/13/2008	11/13/2008	0	NONE	PVT	PVT		sinus conjestion - pt has allergic rhinitis	Med allergies: inapsine, codeine, reglan, vicodin. ASTHMA, ALLERGIC  RHINITIS, LATERAL EPICONDYLITIS  RIGHT, MIGRAINE, GERD, SLEEP DISORDER, HYPERTENSION, BENIGN ESSENTIAL, ARTHRALGIA- R ELBOW, R SHOULDER, REACTION, ACUTE STRESS, NEC and DEPRESSION			1						1	Injection site erythema; Injection site pain; Injection site rash; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U2745AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0614X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0333491	12/01/2008	FL		37		F	12/01/2008	HIVES, DYPSNEA, ITCHING FATIGUE									Y	09/29/2008	09/30/2008	1		MIL	PVT						1						1	Dyspnoea; Fatigue; Pruritus; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0333492	12/01/2008	MD	65.0	65		F	12/01/2008	On 10/30/08 started to develop a large oval induration on the left deltoid that was warm to the touch that progressed into an infection; physician diagnosed cellulitis.  Has a dime size 1/4 hole on her left deltoid muscle.				Y					Y	10/29/2008	10/30/2008	1	placed on Tylenol, Bactrim and Keflex	PUB	PVT	?	?	?			1						1	Cellulitis; Injection site atrophy; Injection site induration; Injection site infection; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA172AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0988F~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0333493	12/01/2008	IN	61.0	61		F	12/01/2008	The patient experienced pain since receiving her flu vaccine on 10/22/08.  On 11/21 she saw her physician and he did an x-ray.  Based on the x-ray the physician believes the vaccine was injected into her biciptical tendon.				Y					U	10/22/2008	10/22/2008	0	Examination and x-ray 11/21/08	UNK	PVT	Unknown	None reported	None reported			1						1	Drug administered at inappropriate site; Pain; X-ray	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881176P~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0333495	12/01/2008	TX	63.0	63		F	12/01/2008	PATIENT HAD SHOT ADMINISTERED AT ABOUT 10:30AM AND EXPERIENCED ADVERSE REACTIONS STARTING AT ABOUT 12:30PM. SHE SAID SHE HAD TROUBLE BREATHING AND A LOW GRADE FEVER.  SHE ALSO FELT AS THOUGH THERE WAS A LUMP IN HER THROAT. SHE WAITED FOR SYMPTOMS TO PASS THINKING THAT IT WAS DUE TO HER USUAL ALLERGIES WHICH SHE SAID CAN BE SEVERE AT TIMES.  ADVERSE REACTIONS PASSED AFTER ABOUT 4 HOURS DURING WHICH TIME SHE TOOK NO MEDICATIONS FOR.									Y	11/24/2008	11/24/2008	0		UNK	PVT			CHRONIC BREATHING CONDITION/ALLERGIES			1						1	Dyspnoea; Pyrexia; Sensation of foreign body	FLU3~SANOFI PASTEUR~U2741AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333496	12/01/2008	MA	38.0	38		M	12/01/2008	Fever of 102.8, nausea and vomitting lasting 3 days.									Y	11/12/2008	11/12/2008	0		UNK	PVT	none	none	none known			1						1	Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2751AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333499	12/01/2008	GA	43.0	44		M	12/01/2008	vaccine received 11-14-08 and pt reports that he had a knot and redness at injection site, and states that afterwards the area turned purple and yellowish and remains tender to palpation.  A local adverse reaction that was explained to patient.  Pt reported problems today 12-1-2008									Y	11/14/2008	11/16/2008	2	none	PVT	PVT	oxycodone, soma, avinza, xanax, ambien, colace, prevacid phenergan, androderm, wellbutrin, Ziac, lidoderm patch, ketamine	none	Hypertension,Anxiety, Depression, Insomina and chronic pain			1						1	Injection site discolouration; Injection site erythema; Injection site mass; Injection site pain; Local reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89124~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333501	12/01/2008	WI	57.0	57		F	12/01/2008	Patient reports that same evening she broke out in a rash starting at the neck which then spread downward over her body.  Her husband who's a physician gave her Benadryl and she was better.									Y	10/20/2008	10/20/2008	0		UNK	PVT	Unknown	Patient reported that she was not sick.	None listed.			1						1	Rash generalised	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA031AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0333547	12/01/2008	IN	69.0	69		M	12/01/2008	This case was reported by the wife of a consumer and described the occurrence of overdose in a 69-year-old male subject who was vaccinated with Flu vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included dementia, depression, dissociative amnesia, heart condition and protein S deficiency. Concurrent medications included Lopressor, Namenda, Aricept and other unknown medication. On 8 November 2008 the subject inadvertently received a 3rd dose of Flu vaccine. The consumer's wife explained that her husband (the subject) inadvertently received three influenza vaccines within a 60 day period. This was considered to be an overdose. It was mentioned upon reporting that the subject had been admitted to multiple facilities for unexplained reasons during that time frame. At an unspecified time following the 3rd flu shot, it was reported that the subject had not eaten well in 51 days. He experienced weakness making him unable to walk. He fell and hit his head and was found in a pool of fresh blood. He was admitted to the intensive care unit on 11 November 2008. he was being treated with a feeding tube at the time of report, but other treatments were unknown. The reporter was unsure which brand of vaccine the subject had received and was unsure if his symptoms were related. The outcome of the events was not specified.					Y				U	11/08/2008			UNK	OTH	OTH	Metoprolol tartrate; Memantine hydrochloride; Donepezil HCl; Unknown	Dementia; Depression; Dissociative Amnesia; Heart  Condition;Protein S Deficiency			A0758012A	1						1	Abasia; Asthenia; Fall; Gastrointestinal tube insertion; Haemorrhage; Head injury; Hypophagia; Incorrect dose administered; Intensive care	FLUX~UNKNOWN MANUFACTURER~~3~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0333558	12/01/2008	PA	1.3	1	.3	F	11/26/2008	Went to ER on 11-02-08 with seizure and fever. Sent home with no work up done. Had another event with fever & seizure on 11/15/08 and was admitted.  12/23/08 Reviewed ER medical records of 11/02/2008. FINAL DX: febrile seizure Records reveal patient experienced generalized shaking, was unresponsive total of 20-25 min.  Had cold s/s of cough & congestion x 3-4 days prior to vaccination.  Fever of 39.1 in ER.  Tx w/antipyretics.  No further seizure activity.  D/C to home w/PCP follow up.				Y	Y	1			Y	10/28/2008	11/02/2008	5	CT head WNL; Blood work WNL; EEG ordered.	PVT	PVT		None	None			1						1	Blood test normal; Computerised tomogram normal; Electroencephalogram; Pyrexia; Convulsion; Hemiplegia	FLU3~SANOFI PASTEUR~UT2787AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0357X~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0424X~1~SC~RA~VARICELLA (VARIVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|MMR~UNKNOWN MANUFACTURER~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~2|VARCEL~UNKNOWN MANUFACTURER~~UNK~UN~UN~VARICELLA (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0333562	12/01/2008	NC	57.0	57		F	12/01/2008	9:00 pm I had chills after retiring for the evening.  Next day I have hazy eye sight. (9:00am) ful listless.									N	11/30/2008	11/30/2008	0	None	OTH	UNK		None	No			1						1	Chills; Vision blurred	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0333565	12/01/2008	NJ	43.0	43		F	11/20/2008	Pt. states 3 hrs. after receiving flu shot c/o cough, throat tightness, sore throat & eye redness.				Y					Y	11/19/2008	11/19/2008	0	X-ray; IV Steroids; IV BENADRYL	PUB	PUB	No	NO	Skin cancer removed summer '08		NJ200803	1						1	Cough; Ocular hyperaemia; Oropharyngeal pain; Throat tightness; X-ray	FLU3~SANOFI PASTEUR~U2808AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333567	12/01/2008	IA	39.0	39		F	11/07/2008	Pt started with fine rash 24-48 hours after vaccine, severe itching. Saw her own doctor-given BENADRYL, rash cont 5-6 days, increased to legs, arms, trunk. Itching cont. Will not get vaccine next year. Had similar reaction last yr (not reported) (not as severe).									Y	10/31/2008	11/02/2008	2	None known	PVT	PVT	Insulin pump	None	NKA; Diabetes			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U2771AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333572	12/01/2008	MS	41.0	41		F	11/20/2008	3 days post the vaccine petechiae found on both legs. Reviewed for 11 days disappearing gradually then tripled higher on legs and now on arms. Aprox 11 days saw another outbreak this time legs and between breast. Continues to have outbreaks.										10/15/2008	10/18/2008	3	Platelet count always within normal results	PUB	UNK	Multivitamin Equate Senior	None	None			1						1	Petechiae; Platelet count normal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLA367LA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0333574	12/01/2008	NJ	72.0	72		M	11/20/2008	Cellulitis - L Arm Temp. - 101.8 redness, swelling, tender which radiated to L axillary area, on 11-01-08 went to medical center.  Received IV antibiotic. Took BACTRIM  DS BID for 10 days				Y					Y	10/30/2008	10/31/2008	1		PUB	UNK	ELAVIL 50mg- HS;  ZANTAC 150mg- BID;  IMITREX 50mg for migraine headache PRN	None	None			1						1	Cellulitis; Erythema; Pyrexia; Swelling; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA166AA~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1076X~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0333575	12/01/2008	VA	1.0	1	.0	F	11/25/2008	Red indurated 1cm raised rash x 2 spots near VARIVAX injection site. Occurred 3 days status post shot. Fever to 102 deg. and >100 blanching measles 8 days after vaccination  No scabbing, rash faded over time.									Y	11/10/2008	11/13/2008	3	None	PVT	PVT	none known	none reported or observed	Infant born by C/S for breech presentation-healthy infant			1						1	Injection site erythema; Injection site induration; Injection site rash; Injection site swelling; Measles; Pallor; Pyrexia	FLU3~SANOFI PASTEUR~U2788FA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0917X~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0955X~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0333577	12/01/2008	MA	9.0			M	11/24/2008	Pt. had a flu shot then complained of pressure in his throat, evaluated by EMT'S, BP 100/70, S/S resolved on their own quickly.									Y	11/22/2008	11/22/2008	0		PUB	OTH	Unknown		?Allergy to red food dye.			1						1	Throat tightness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333578	12/01/2008	MA	66.0			F	11/24/2008	pt. felt heat and  warmth  throughout body.  Settled in chest, BP increase and tingling in fingers funny feeling in throat.									U	11/22/2008	11/22/2008	0		PUB	OTH	Unknown	Unknown	Unknown			1						1	Blood pressure increased; Chest discomfort; Feeling hot; Paraesthesia; Throat irritation	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333579	12/01/2008	MA	67.0			M	11/24/2008	Pt. c/o tremors and shaking uncontrollably, and was monitored by adverse effects  monitoring coordinator, and EMTs. Paramedics arrived, and pt. was transport to ER.				Y					U	11/22/2008	11/22/2008	0	Unknown	OTH	OTH	Unknown	Unknown	Diabetes			1						1	Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0333583	12/01/2008	PA	38.0	38		F	11/18/2008	Pain in shoulder, back, and arm despite mult. analgesics and interfering w/ ADL's; >1 mo.									N	10/14/2008	10/14/2008	0		PUB	OTH	PREVACID; ALDACTONE; TAGAMET; LUNESTA	None	DAYPRO; KEFLEX			1						1	Activities of daily living impaired; Back pain; Musculoskeletal pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2789CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333584	12/01/2008	PA	32.0	32		F	11/20/2008	Swelling at injection site w/tingling in hand and petechia distally near antecubital fossa.									Y	10/17/2008	10/18/2008	1	CBC; plats; PT/PTT - all w/in normal limits.	PUB	UNK	MOTRIN	None	Pen			1						1	Activated partial thromboplastin time; Full blood count normal; Injection site swelling; Paraesthesia; Petechiae; Platelet count normal; Prothrombin time normal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~892971P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333585	12/01/2008	PA	39.0	39		F	11/18/2008	Arm/shoulder/back pain despite mult. analgesics and interfering w/ ADL's >lmo.									N	10/16/2008	10/16/2008	0		PUB	UNK	No meds.	None	None x Latex (orally in dentist office)			1						1	Activities of daily living impaired; Back pain; Musculoskeletal pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2793EA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333586	12/01/2008	PA	55.0	55		F	11/18/2008	Arm/shoulder/back pain despite mult. analgesics and interfering w/ADL's; >1 mo.									N	10/14/2008	10/14/2008	0		PUB	OTH	VESICARE; FOSAMAX; NEXIUM; LUNESTA; PAXIL; XANAX; AMITIZA	None	DARVON; Codeine; Steroids			1						1	Activities of daily living impaired; Back pain; Musculoskeletal pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2789CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333587	12/01/2008	PA	23.0	23		F	11/18/2008	Pain in shoulder, back, and arm despite mult. analgesics and interfering w/ ADL's; >1mo.									N	10/14/2008	10/14/2008	0		PUB	UNK		None	Codeine			1						1	Activities of daily living impaired; Back pain; Musculoskeletal pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2789CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333588	12/01/2008	PA	25.0	25		F	11/18/2008	Pain in shoulder, back, and arm despite mult. analgesics and interfering w/ ADL's; >1 mo.									Y	10/14/2008	10/14/2008	0		PUB	UNK	None	None	NKA			1						1	Activities of daily living impaired; Back pain; Musculoskeletal pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2789~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333590	12/01/2008	IA	8.0	8		F	11/25/2008	Pt with Hx RAD episodes as infant, resolved. Pt deemed FLUMIST candidate of received dose 10/23/08. Pt had subsequently developed URI/LRI with reactive airway component (11/24/08) and begun on inhaled. Bagonist. Prescribed albuterol 11/24/2008				Y					N	10/23/2008	11/03/2008	11	continued: I suspect this is a coincidental observation.	PVT	PUB	Topical steroid ointnet for eczema.	Pharyngitis	Past med Hx RAD3 -->remote with no recent sxs; allergy rhinitis; eczema;			1						1	Bronchial hyperreactivity; Condition aggravated; Lower respiratory tract infection; Upper respiratory tract infection	FLUN3~MEDIMMUNE VACCINES, INC.~500559P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0333592	12/01/2008	NC	9.0	9		M	12/01/2008	Raised, red rash over face, chest, back, legs. Cool compresses to rash and BENADRYL for itch.				Y					Y	11/25/2008	11/25/2008	0		PVT	PUB			None			1						1	Rash	FLU3~SANOFI PASTEUR~U2798DA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333599	12/01/2008	GA	32.0	32		F	10/16/2008	Had shot at 1:30 pm- at 4:30 pm throat felt like had phlegm- started wheezing- face swollen, numbness (B) side faces. Some S. O. B. to walk in clinic- stated HR increase- allergic reaction- gave DECADRON. Short acting injection and long acting DECADRON- relief within 30 min.- no swelling in site. Had flu shot 3 years ago.				Y					Y	10/15/2008	10/15/2008	0	None	PUB	OTH	None					1						1	Dyspnoea; Heart rate increased; Hypersensitivity; Hypoaesthesia facial; Increased upper airway secretion; Swelling face; Wheezing	FLU3~SANOFI PASTEUR~2832AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333601	12/01/2008	HI	9.0	9		F	11/21/2008	Fainting episode after receiving FLUMIST vaccine. Episode occurred while student was walking back to class therefore fell hitting head on the side walk student was taken to the emergency room to be monitored for severe had injury.				Y					Y	11/17/2008	11/17/2008	0		OTH	MIL		No illness at time of vaccination	No medical condition that we are aware of.		1110808	1						1	Fall; Head injury; Syncope	FLUN3~MEDIMMUNE VACCINES, INC.~500560P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0333688	12/01/2008	KY	89.0	89		M	11/26/2008	Pt. Reported to me one week after, that he had severe uncontrollable body jerks which subsided after a few hours, also had an 8 inch bruise at injection site (R) Deltoid									Y	10/14/2008	10/14/2008	0	None	OTH	PUB	AVODART BENICAR HCT TOPROL LOATAB	NONE	Hypertension, BPH			1						1	Dyskinesia; Injection site haematoma	FLU3~CSL LIMITED~02349111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0333312	12/02/2008	NJ	69.0	69		F	12/02/2008	Recieved Flu and Pneumonia on Monday, Nov. 24th, 2 hours after developed severe pain at injection site.  It then became red and hot.  Went to PMD on Wednesday, Nove 26th and was hospitalized for 2 days, given IV antibiotics.  1/15/2009 ER record received for DOS 11/26-27/08 with DX: Left arm cellulitis. HTN. Hypothyroidism. Pt presented with redness and pain of the L arm x 3 days. PE (+) for erythema, warmth and tenderness to palpation. Tx abx.					Y	2			Y	11/24/2008	11/24/2008	0	not known. Labs and Diagnostics:  CBC with normal WBC. Blood glucose 125. Blood cx (-).	UNK	UNK		no	diabetes, hypertension. PMH:  HTN, DM, Hypothroidism			1						2	Injection site swelling; Injection site erythema; Injection site pain; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA181AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1076X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflla181aa~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~2|PPV~MERCK & CO. INC.~1076x~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0333569	12/02/2008	CA	51.0	50		F	12/01/2008	Pt. went to sleep and woke up with stiff/painful right arm, which radiate to neck/jaw/and down to the rest of the arm. Pt. took CLARITIN and it helping to relieve the symptom. Lasted 2 days.									Y	11/25/2008	11/26/2008	1		OTH	OTH						1						1	Musculoskeletal stiffness; Neck pain; Pain in extremity; Pain in jaw	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89987~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1132U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0333570	12/02/2008	TN	7.0	7		M	11/21/2008	After FLUZONE patient broke out in rash and whelps. DIPHENYLDRAMINE 25 mg by mouth DOT given. Monitored consistently by nurse and APN x 20 minutes, monitored s/s, vs and educated about action plan if worsens.									Y	10/22/2008	10/22/2008	0		PUB	PUB						1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~U2810AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333576	12/02/2008	MA	60.0			F	11/24/2008	Felt faint, was diaphoretic, pale. Pt refused transport to hospital. Sat in chair after having flu shot, EMTS on scene. Generalized pallor and diaphoresis. Pt was conscious and alert and oriented.				Y					Y	11/22/2008	11/22/2008	0		OTH	OTH	Unknown	Unknown	Unknown			1						1	Dizziness; Hyperhidrosis; Pallor	FLU3~SANOFI PASTEUR~U2760AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333596	12/02/2008	CA	31.0	31		F	11/24/2008	15-20 min - left arm discomfort from shoulder to elbow. 30 min. - aching increased; moved to forearm and hand. 40 min. - pain/dull/throbbing throughout arm from shoulder to hand. 40-1hr1/2 - continued throbbing. 1hr 1/2 took 2 ibuprofen. 1hr 45-2 hr, pain decreased.									Y	11/24/2008	11/24/2008	0		OTH	PVT	BCP		None			1						1	Limb discomfort; Pain	FLU3~SANOFI PASTEUR~U3751AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333603	12/02/2008	OH	32.0	32		F	11/20/2008	Pt. called and stated that evening of 11/19/08 she started having hoarseness and when she woke up on 11/20/08, she was hoarse and had a knot in her armpit. She also told me that her arm had been sore and Advil helped with soreness. Advised her to call family Doctor and to please call us back with what he told her.									Y	11/17/2008	11/19/2008	2		PUB	PUB		Diagnosed with scabies on 11/15/08 and started treatment				1						1	Dysphonia; Induration; Pain in extremity	FLU3~SANOFI PASTEUR~U2832AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333610	12/02/2008		68.0			F	11/25/2008	This case was reported by a healthcare professional and described the occurrence of red sores-hands in a 68-year-old female subject who was vaccinated with Influenza vaccine (manufacturer unspecified). The subject's medical history included bug bite. Concurrent medications included PREMARIN, PROTONIX, PEPCID, ZOCOR and WELCHOL. In 2008, the subject received a dose of Influenza vaccine (unknown). In 2008, at an unspecified time after vaccination with Influenza vaccine, the subject experienced red sores-hands, sores on feet, hand pain, itching and rash. The subject received influenza vaccine approximately six to eight weeks prior to this report, specific vaccine was unknown. The palms of the subjects hands and bottom of feet were red and blanched when pushed in. Her feet and hands are painful. With this facility, the only difference from normal was her IgG was elevated. Prednisolone was prescribed and was not helping according to subject. The subject also had a bug bite two to three months ago. The bug bite was treated by primary care with antibiotics. The subject previously received flu shots before with no reaction and no allergy. It started as itchy and now back and forth between itchy to painful. Rash appeared one to two days after injection. Rash became worse during the day and then improved like in a cycle. The healthcare professional considered the events were disabling. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with Influenza vaccine.				Y				Y	N				IgG, elevated	OTH	OTH	Conjugated estrogens; Pantoprazole; Famotidine; Simvastatin; Colesevelam hydrochloride	Unknown	Bug Bite; The subject had previously received influenza vaccinations and no adverse events were reported. No adverse events were reported following receipt of prior immunizations.		A0758232A	1						1	Blood immunoglobulin G increased; Pain in extremity; Pallor; Palmar-plantar erythrodysaesthesia syndrome; Pruritus; Rash; Skin lesion	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0333612	12/02/2008	NC	77.0	77		F	12/02/2008	Diffuse pruritic morbilliform rash noted on about 11/24/08, fairly impressive rash, looked like drug eruption.									N	11/20/2008	11/24/2008	4		PVT	UNK		None	MYSOLINE, codeine, Lisinopril.			1						1	Rash morbilliform; Rash pruritic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88907~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARZOS~MERCK & CO. INC.~1418X~UNK~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0333613	12/02/2008	MI	54.0	54		F	11/23/2008	4x4 raised red and hardened, itchy and soar, hot patch at injection site. Lasted about 4 days before symptoms subside. About 1 wk before all symptoms are gone.									Y	11/10/2008	11/10/2008	0		UNK	UNK						1						1	Injection site erythema; Injection site pain; Injection site pruritus; Injection site rash; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8788205~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333635	12/02/2008	VA	43.0	43		F	12/02/2008	hives, lip swelling, dyspnea starting 90 minutes after influenza vaccine. 12/23/2008 MR received for DOS 11/25-26/2008 with DX: Allergic Reaction. Pt presented with itching, urticaria, SOB, throat & tongue swelling and swelling of face.  Diffues rash noted on PE. Chest tightness resolved. Tx with Benadryl, steroids with improvement. Observed o/n and d/c.				Y	Y	1			Y	11/25/2008	11/25/2008	0	Labs and Diagnostics:  EKG (+) for sinus tach and non-specific ST abnormality. Transthoracic echo (+) for mild miral regurg, otherwise WNL. CBC with WBC 11.97. X-ray neck WNL.	UNK	UNK	zyrtec,flonase, levothyroxine	sinusitis	seasonal allergies, Meniere's, obesity, back pain PMH: hypothyroid. tonsillectomy	none~ ()~~0.00~In Patient		1						1	Dyspnoea; Lip swelling; Urticaria	FLU3~SANOFI PASTEUR~u2764AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0333640	12/02/2008	TX	53.0			M	12/02/2008	More than one month has passed, and the injection site,left arm, is still sore. Also, my left arm seems to have become siginificantly weaker.									N					UNK	UNK		none		none~ ()~NULL~~In Patient		1						1	Injection site pain; Muscular weakness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0333642	12/02/2008	NC	72.0	72		U	12/02/2008	GIVEN ADACEL DESPITE OVER AGE LIMIT									U	11/26/2008			N/A	PUB	UNK	N/A	N/A	N/A			1						1	Inappropriate schedule of drug administration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~~UNK~IM~~TDAP (ADACEL)~1	USA		Influenza
0333643	12/02/2008	OH	16.0	16		F	12/02/2008	OCTOBER 10, 2007:  Patient completes a routine physical examination from Dr.  Patient is not experiencing any health problems and none are found during this examination.  Dr. recommends patient receive two vaccines due to her age: (1) Meningitis vaccine  (2) Cervical cancer vaccine series.  After discussion with Dr., we decide to receive only the Meningitis Vaccine at this time. One shot of Menactra was administered at this time.  NOVEMBER 18, 2007:  Patient informs me of a small raised bump on the back top of her head approximately 1 in diameter.  I told her to let me know if this bump doesn't go away. JANUARY 24, 2008: My wife is sitting on our couch rubbing patient head when she feels a large mass approximately 4 in diameter contouring to the top back of patient's skull.  Patient said it felt like part of her head when she was washing her hair.  I immediately took patient to Hospital to be examined.  An X-Ray showed a large bone distortion at the site of the mass, and we were advised to seek medical attention promptly at  Hospital in downtown.  An appointment was scheduled with neuro-surgeon on 1-25-08.  January 25, 2008:  Patient sees Dr., who examines patient, and orders a series of tests and scans.  The tests and scans indicate a lesion has developed in the meninges area of her skull, and is destroying a large portion of the skull bone in this area.  Dr. recommends surgery as soon as possible to remove the infected bone and area. FEBRUARY 5, 2008:  Patient has surgery at Hospital in downtown.  A large 4 section of her skull bone is cut out, and replaced with a temporary metal plate. FEBRUARY 25, 2008:  Patient has appointment with Dr. to evaluate her recovery.  Scan performed to size opening in patient's skull for fitting a permanent plastic covering for this area.  Surgery scheduled for May 2008, to insert plastic covering into opening. MAY 5, 2008:  Patient's pre-op work at Hospital. MAY 13, 2008: Patient has skull reconstruction surgery completed.  She will need to be seen annaully for evaluations.  1/20/09 Reviewed hospital medical records of 5/13-5/14/2008 & additional clinic records of 1/24-5/27/2008. FINAL DX: intraosseous calavarial meningioma, s/p cranioplasty Records revela patient experienced bony & scalp occipital lump.  Had been initially noted appro 3 mos earlier & thought to be secondary to trauma.  Thought to be resolved until 1/24/08.  Seen in Urgent Care.  Suspicious for osteosarcoma & referred to Heme/Onc clinic.  Seen in clinic 1/25/08 & sent for neurosurgery eval.  Craniectomy for mass excision done 2/5/08 & the resulting calavarial defect was repaired 5/13/08. Follow-up: Meninges lining shows abnormalities and has affected over laying skull bone. Surgical removed of this bone was necessary (cranioplasty) in 2008. See pictures a large plastic implant has replaced skull bone, however the meninge lining could not be removed.			Y	Y	Y	4		Y	N	10/10/2007	11/18/2007	39	January 24, 2008: X-ray @ hospital shows 4 mass on top back of patient's skull. back. January 25, 2008 to FEBRARY 1, 2008: Scans @ hospital downtown confirm a lesion is attacking the skull bone in this area. FEBRUARY 5, 2008: Patient has surgery to remove infected skull bone. May 13, 2008: Patient has reconstruction surgery to replace missing bone.  LABS: Skull x-ray abnormal.  CT scan & MRI of head abnormal w/mixed lytic & blastic expansile cortical lesion parietal bone. 3-D CT scan abnormal & c/w 7-cm diameter area of moth eaten bone in midline posterior parietal region.	UNK	UNK	Patient has been taking an oral contraceptive to treat a moderate acne problem since 12 years old.	None	Moderate Acne  PMH: ADHD, anemia.  Family hx: brain tumor.			1						1	Mass; Meningeal neoplasm; Ostectomy; Rash maculo-papular; Skull X-ray abnormal; Surgery	FLU3~SANOFI PASTEUR~U2448AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2402AA~UNK~IM~~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0333644	12/02/2008	NY	62.0	62		F	12/02/2008	My Arm became red and swollen and painful.  This occurred 48 hours after flu shot.  After three weeks my arm did recover mostly, but is still a little red.  I continue to put cortisone cream on it.									U	11/14/2008	11/16/2008	2		PUB	PVT						1						1	Erythema; Oedema peripheral; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0333645	12/02/2008	WI	57.0	57		F	12/02/2008	Itchy rash around site of vaccine administration beginning 4 days after administration and continuing to spread outward at time of this form being filled out.  Also, hot sensation generally throughout bones in the evenings.				Y					U	11/20/2008	11/24/2008	4		PVT	PVT	Tylenol #3, Fosamax, Aspirin, Cipro Ophthalmic drops, Relpax, Vytorin, lisinopril, metformin, Prilosec.	None	Topamax - dizziness, diabetes mellitus type 2, dyslipidemia, GERD			1						1	Feeling hot; Injection site pruritus; Injection site rash	FLU3~SANOFI PASTEUR~U2804AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1076X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0333649	12/02/2008	PA	51.0	51		F	12/02/2008	PPV administered @ 3 PM.  By 6 PM pt. reports arm swollen and very painful.  By 9 PM pt. reports she felt feverish, chills, vomited, diaphoretic. Seen by PCP 11/24/08.  Prescribed 6 day course of steroids to reduce inflammation and swelling.  Pt. reports each day the arm is improving.  Last conversation with patient 11/26/08.				Y					U	11/21/2008	11/21/2008	0	None known	PUB	PUB	Diovan, Vesicare, Femtrace, Effexor	None	High BP, Allergies to Penicillin, Tetracycline, codeine			1						1	Chills; Hyperhidrosis; Inflammation; Oedema peripheral; Pain in extremity; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2806AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0989U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0333653	12/02/2008	OR	4.0	4		F	12/02/2008	Day following vaccination area was swollen and red, slightly itchy.  On Rt upper thigh had a large fading giant macule, 19.5x13 cm in size.									U	11/24/2008	11/25/2008	1	none	PVT	PUB	none	none	Heart Murmur, Eczema			1						1	Injection site erythema; Injection site pruritus; Injection site reaction; Injection site swelling; Rash macular	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B103AB~1~IM~RL~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~U2808AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0356X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0605X~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0333654	12/02/2008	FL	35.0	35		F	12/02/2008	Persistent but improving pain to site of injection. Still has pain after 10/17/08 administration. Pain increases with adduction motion. No other complaints.									U	10/17/2008	10/21/2008	4	N/A	UNK	UNK	None	None				1						1	Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA350CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0333657	12/02/2008	CA	46.0	46		M	12/02/2008	- Break out pruritic rash on hands, right eye, back of neck and head, and red rash around angiogram site. Patient was given cortisone injection and was told to take benadryl at night.				Y					Y	11/07/2008	11/08/2008	1		UNK	UNK	Triamcinolone cream, Mometasone, Rabeprazole					1						1	Rash erythematous; Rash pruritic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88129-AP~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0333658	12/02/2008	IL	37.0	37		F	12/02/2008	Extreme nausea, dizziness along with bouncing vision  and double vision.There also was a loss of reflexes in many extremities.There also was a drop in blood pressure.Had eye drooping. paralysis of eyes.Treatments included plasmaphresis and Ivig treatments.There was also many medicines after discharge from hospital.This was an horrible time in our families lifes. 1/7/09-records received for DOS 10/16-10/22/08-DX DC: Blurred vision probably related to Miller Fisher variant of Guillain-Barre syndrome. Vertigo. Mild leukocytosis without clear source. Admitted with C/O increased blurred vision. Left eye ptosis, nausea. Dizziness began 12 days prior.Plasmapheresis. Transferred to tertiary care center.  2/17/09-records received for DOS 10/22-11/4/08-transferred to rehab facility with IVIG.  02/01/2010 I still experience dizziness and double vision at times. My left side of my face is also still affected at times.			Y	Y	Y	22	Y		N	10/01/2008	10/16/2008	15	There was many tests that include many blood tests.Two spinal taps.Many Ct scans and Mri's.Development of Miller Fisher syndrome and Ocular Myasthenia Gravis 1/7/09-records received- MRI brain unremarkable. CSF protein 39. CSF cultures negative.  2/17/09-records received-Electrodiagnostic study without any evidence of deficit at Neuromuscular junction. PE demonstrates bilateral horizontal gaze paralysis with preservation of superior and inferior ductions. No upper or lower extremity weaknesses. CSF culture no growth, protein 29 and Glucose 64.	UNK	UNK		none	none 1/7/09-records received-Allergy to Penicillin and tetracycline. PMH;upper respiratory infection.			1						1	Areflexia; Blood pressure decreased; Blood product transfusion; Blood test; Computerised tomogram; Diplopia; Dizziness; Facial palsy; IIIrd nerve paralysis; Lumbar puncture; Miller Fisher syndrome; Nausea; Ocular myasthenia; Ophthalmoplegia; Plasmapheresis; Visual impairment	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLL185AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening,Hospitalisation	Influenza
0333661	12/02/2008	WA	0.17	0	.2	M	12/02/2008	N/A									Y	11/14/2008	11/14/2008	0	n a	PVT	MIL		n/a	n/a			1						1	Inappropriate schedule of drug administration	DTAPIPVHIB~SANOFI PASTEUR~c2922aa~1~IM~LL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~ut278699~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1106f~1~IM~LL~HEP B (FOREIGN)~1|PNC~PFIZER\WYETH~c27701~1~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0333662	12/02/2008	IN	69.0	69		F	12/02/2008	Patient said that she could tell after her shot that something was wrong, although she did not inform the pharmacist.  She said that she felt sick the next day after the shot. Now her arm has been hurting since 11/3/08 that she received the shot.  She saw a doctor on the 14 and he said that it was nerve pain.				Y					U	11/03/2008	11/03/2008	0		UNK	UNK						1						1	Malaise; Neuralgia; Pain in extremity	FLU3~SANOFI PASTEUR~u2741aa~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333663	12/02/2008	KS	37.0	37		F	12/02/2008	First had flu mist 2007 and started having severe symptoms of severe headache on back of head and then left side of head and neck.  Burning, painful sensation along occipital nerve area on left side. Symptoms lasted 4-6 months.  2007 received flu shot and had minor symptoms.  Had flu mist again 2008 and started symptoms all over again same area and type but not as severe as first year.  Saw 2 neurologists and ear-nost-throat specialist who could not find cause.  Did suggest occipital neuralgia.				Y					Y	10/05/2008	10/07/2008	2	Tested positive for Epstein-Barr due to Mono in 2001.  Had measles at age 18	MIL	MIL	None	None	None	none~ ()~NULL~~In Patient|none~ ()~NULL~~In Sibling1|none~ ()~NULL~~In Sibling2		1						1	Burning sensation; Ear, nose and throat examination normal; Epstein-Barr virus test; Headache; Neuralgia; Neurological examination normal; Occipital neuralgia; Vaccine positive rechallenge	FLUN3~MEDIMMUNE VACCINES, INC.~0~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0333669	12/02/2008	GA	55.0	55		F	12/02/2008	This case was reported by a pharmacist and described the occurrence of fever in a 55-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 10 November 2008 at 08:00, the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). On 10 November 2008, less than one day after vaccination with FLULAVAL, the subject experienced fever. The pharmacist received a call from the subject's husband, who reported that his wife experienced a very high fever since receiving the FLULAVAL vaccination. The husband noted that the fever had worsened to 104 degrees. The pharmacist did not have any further details. Relevant test results included body temperature of 104 degrees. At the time of reporting the event was worse. Follow-up information was received on 01 December 2008, via pharmacist, who reported he spoke with the subject's son. He reported the subject's temperature rose to 106.7 the next day. She was not drinking and was unresponsive. She went to the emergency room and the physician ran tests, but it showed nothing. She was hospitalized and developed pneumonia. The subject was discharged and is doing better. It was reported that the onset date was 10 October 2008, which conflicts with previously reported date of 10 November 2008. The subject was hospitalised and the pharmacist considered the events were disabling. At the time of reporting the events were improved. The pharmacist considered the events were possibly related to vaccination with FLULAVAL.					Y	0		Y	N	11/10/2008	11/10/2008	0	Body temperature, 106.7 degrees; Body temperature, 104 degrees	OTH	PVT		Unknown	No concomitant medications or relevant medical history.  The subject had previously received influenza vaccinations and no adverse events were reported.  No adverse events were reported following receipt of prior immunizations.		A0757723A	1						1	Body temperature increased; Fluid intake reduced; Pneumonia; Pyrexia; Unresponsive to stimuli	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation,Disabling	Influenza
0333670	12/02/2008	AL	41.0	41		F	12/02/2008	This case was reported by a pharmacist (also the subject's sister) and described the occurrence of injection site redness in a 41-year-old female subject who was vaccinated with FLULAVAL, GlaxoSmithKline.  Concurrent medications included Fluoxetine.  On 27 September 2008 at 22:00 the subject received a dose of FLULAVAL at 0.5 ml in the left arm.  Several days following administration of FLULAVAL, the subject experienced injection site redness, injection site soreness, numbness at the injection site and injection site tingling.  It was also reported that the subject was experiencing arm paralysis which also began several days following FLULAVAL injection.  She has to move the affected arm with her other arm, however, she does have feeling in the affected arm.  The pharmacist considered the events were clinically significant (or requiring intervention).  The subject was treated with Ibuprofen.  At the time of reporting the events seemed to be worsening and becoming disabling.  The pharmacist considered the events were possibly related to vaccination with FLULAVAL.								Y	U	09/27/2008			Unk	OTH	PVT	Fluoxetine	Unknown	The subject has no known medical history.  There are no known adverse events to previous flu vaccines or other vaccinations.		A0758786A	1						1	Injection site anaesthesia; Injection site erythema; Injection site pain; Injection site reaction; Monoplegia; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLAA175AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Disabling	Influenza
0333671	12/02/2008	OR				U	12/02/2008	This case was reported by a healthcare professional and described the occurrence of vomiting in an elderly subject of unspecified gender who was vaccinated with FLULAVAL, (GlaxoSmithKline). On 05 or 21 November 2008 the subject received a dose of FLULAVAL at 0.5 ml. On 26 November 2008, the subject developed severe nausea, vomiting, diarrhea and body pain. The nursing supervisor of the facility was concerned that the outbreak was related to vaccination with FLULAVAL. This was considered to be a product complaint. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the events were unresolved, but the outcome of nausea was not specifically reported. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. A health educator requested information for a specific lot of FLULAVAL. A retirement home vaccinated a number of adults and elderly subjects on two different dates. On 26 November 2008, approximately 40 of these individuals (staff and residents) developed severe nausea, vomiting and diarrhea. Body aches were also documented. The nursing supervisor of the facility was concerned that there outbreaks were related to vaccination with FLULAVAL. Three of the subjects developed dehydration and were also hospitalized. The facility was ruling out viral causes also. Linked cases numbers include: A0758822A, A0758823A, A0758824A, and A0758825A.			Y						U	11/01/2008	11/26/2008	25	UNK	OTH	OTH		Unknown	Linked cases number include: A0758822A, A0758823A, A0758824A and A0758825A.		A0758812A	1						1	Dehydration; Diarrhoea; Nausea; Pain; Pharmaceutical product complaint; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA208AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening	Influenza
0333672	12/02/2008	OR				U	12/02/2008	This case was reported by a healthcare professional and described the occurrence of vomiting in an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 05 or 21 November 2008 the subject received a dose of FLULAVAL at 0.5 ml. On 26 November 2008, the subject developed severe nausea, vomiting, diarrhea and body pain. The nursing supervisor of the facility was concerned that the outbreak was related to vaccination with FLULAVAL. This was considered to be a product complaint. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the events were unresolved, but the outcome of nausea was not specifically reported. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. A health educator requested information for a specific lot of FLULAVAL. A retirement home vaccinated a number of adults and elderly subjects on two different dates. On 26 November 2008, approximately 40 of these individuals (staff and residents) developed severe nausea, vomiting and diarrhea. Body aches were also documented. The nursing supervisor of the facility was concerned that these outbreaks were related to vaccination with FLULAVAL. Three of the subjects developed dehydration and were also hospitalized. The facility was ruling out viral causes also. Linked cases numbers include: A0758812A, A0758823A, A0758824A and A0758825A.			Y						U	11/01/2008	11/26/2008	25	UNK	OTH	OTH		Unknown	Linked cases numbers include: A0758812A, A0758823A, A0758824A and A0758825A.		A0758822A	1						1	Diarrhoea; Nausea; Pain; Pharmaceutical product complaint; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA208AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening	Influenza
0333673	12/02/2008	OR				U	12/02/2008	This case was reported by a healthcare professional and described the occurrence of vomiting in an adult (possibly elderly) subject of unspecified gender who was vaccinated with FLULAVAL(GlaxoSmithKline). On 05 or 21 November 2008 the subject received a dose of FLULAVAL at 0.5 ml. On 26 November 2008, the subject developed severe nausea, vomiting, diarrhea and body pain. Dehydration was also reported. The nursing supervisor of the facility was concerned that the outbreak was related to vaccination with FLULAVAL. This was considered to be a product complaint. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). The subject was hospitalized. At the time of reporting the events were unresolved, but the outcome of nausea and dehydration was not specifically reported. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. A health educator requested information for a specific lot of FLULAVAL. A retirement home vaccinated a number of adults and elderly subjects on two different dates. On 26 November 2008, approximately 40 of these individuals (staff and residents) developed severe nausea, vomiting and diarrhea. Body aches were also documented. The nursing supervisor of the facility was concerned that these outbreaks were related to vaccination with FLULAVAL. Three of the subjects developed dehydration and were also hospitalized. The facility was ruling out viral causes also. Linked cases numbers include: A0758812A, A0758822A, A0758824A and A0758825A.			Y		Y				U	11/01/2008	11/26/2008	25	UNK	OTH	OTH		Unknown	Linked cases numbers include: A0758812A, A0758822A, A0758824A and A0758825A.		A0758823A	1						1	Dehydration; Diarrhoea; Nausea; Pain; Pharmaceutical product complaint; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA208AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening,Hospitalisation	Influenza
0333674	12/02/2008	OR				U	12/02/2008	This case was reported by a healthcare professional and described the occurrence of vomiting in an adult (possibly elderly) subject of unspecified gender who was vaccinated with FLULAVAL, (GlaxoSmithKline).  On 05 or 21 November 2008 the subject received a dose of FLULAVAL at 0.5 ml.  On 26 November 2008, the subject developed severe nausea, vomiting, diarrhea and body pain.  Dehydration was also reported.  The nursing supervisor of the facility was concerned that the outbreak was related to vaccination with FLULAVAL.  This was considered to be a product complaint.  The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention).  The subject was hospitalized.  At the time of reporting the events were unresolved, but the outcome of nausea and dehydration was not specifically reported. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL.  A health educator requested information for a specific lot of FLULAVAL.  A retirement home vaccinated a number of adults and elderly subjects on two different dates.  On 26 November 2008, approximately 40 of these individuals (staff and residents) developed severe nausea, vomiting and diarrhea.  Body aches were also documented.  The nursing supervisor of the facility was concerned that these outbreaks were related to vaccination with FLULAVAL.  Three of the subjects developed dehydration and were also hospitalized.  The facility was ruling out viral causes also. Linked cases numbers include:  A0758812A, A0758823A, A0758823A and A0758825A.			Y		Y	0			U	11/01/2008	11/26/2008	25	UNK	OTH	OTH		Unknown	Linked cases numbers include: A0758812A, A0758822A, A0758823A and A0758825A.		A0758824A	1						1	Dehydration; Diarrhoea; Nausea; Pain; Pharmaceutical product complaint; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA208AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening,Hospitalisation	Influenza
0333675	12/02/2008	OR				U	12/02/2008	This case was reported by a healthcare professional and described the occurrence of vomiting in an adult (possibly elderly) subject of unspecified gender who was vaccinated with FLULAVAL, (GlaxoSmithKline). On 05 or 21 November 2008 the subject received a dose of FLULAVAL at 0.5 ml. On 26 November 2008, the subject developed severe nausea, vomiting, diarrhea and body pain. Dehydration was also reported. The nursing supervisor of the facility was concerned that the outbreak was related to vaccination with FLULAVAL. This was considered to be a product complaint. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). The subject was hospitalized. At the time of reporting the events were unresolved, but the outcome of nausea and dehydration was not specifically reported. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. A health educator requested information for a specific lot of FLULAVAL. A retirement home vaccinated a number of adults and elderly subjects on two different dates. On 26 November 2008, approximately 40 of these individuals (staff and residents) developed severe nausea, vomiting and diarrhea. Body aches were also documented. The nursing supervisor of the facility was concerned that these outbreaks were related to vaccination with FLULAVAL. Three of the subjects developed dehydration and were also hospitalized. The facility was ruling out viral causes also. Linked cases numbers include: A0758812A, A0758822A, A0758823A and A0758824A.			Y		Y	0			U	11/01/2008	11/26/2008	25	UNK	OTH	OTH		Unknown	Linked cases numbers include: A0758812A, A0758822A, A0758823A and A0758824A.		A0758825A	1						1	Dehydration; Diarrhoea; Nausea; Pain; Pharmaceutical product complaint; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA208AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening,Hospitalisation	Influenza
0333676	12/02/2008		12.0	12		M	12/03/2008	We received from a physician the following information on 19 NOV 2008: A 12-year-old boy, born on 11 AUG 1996, received FLUVIRIN, batch-no. 89976, on 13 NOV 2008. Over the weekend the patient developed influenza-like symptoms (weakness, aches, sore throat). It is reported that on 18 NOV 2008 he had a tonic-clonic seizure lasting for 5 minutes. The seizure did not require a treatment. At the time of report the patient has malaise and is still ill. An EEG is planned.									Y	11/13/2008	11/18/2008	5		OTH	OTH	No other medications	Unknown			MA20082961	1						1	Asthenia; Grand mal convulsion; Influenza like illness; Malaise; Oropharyngeal pain; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89976~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333677	12/02/2008	OH	49.0	49		F	11/28/2008	3 hours after vaccine, severe arm pain, unable to move left arm. Fever 102. Leukocytosis 12/2/08. Still with severe arm pain and unable to perform active range of motion.  12/19/2008 MR received for DOS 11/25-26/2008 with DX: L shoulder myositis s/p pneumonia vaccine.  Pt presented severe, worsening L arm pain. PE (+) for elevated BP 214/88, T=101.9'F, decreased ROM of L shoulder with (+) tenderness. Tx with abx, anti-inflammatories and pain meds and d/c to f/u w/ PCP.					Y	1			Y	11/26/2008	11/26/2008	0	increased WBC.  Labs and Diagnostics:  CBC with WBC 19.7. K+ 5.2. EKG (+) for sinus tach. CXR WNL. Shoulder X-ray (+) for calcification and spurring. Cardiac markers WNL.	PVT	PVT		Fibramyalgia, chronic bronchitis, ulcerativecholitis, decreased thyroid, HTN	PMH:  Ulcerative colitis, HTN, hypothyroidism, asthma. Allergies, MS, PCN, sulfa, lorabid, zoloft, zosyn./			1						1	Injected limb mobility decreased; Leukocytosis; Pain in extremity; Pyrexia; White blood cell count increased	FLU3~SANOFI PASTEUR~U2810AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1076X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0333678	12/02/2008	OH	55.0	55		M	12/01/2008	Flu vaccine administered November 10, 2008, left deltoid.  Pt has experienced pain (8 on scale 1-10) from site of injection to elbow.  Hurts to rotate arm.  Decreased strength for holding items.  Unable to left arm above elbow height.  Symptoms have occured X 3 wks and continue.									Y	11/10/2008	11/11/2008	1		PUB	OTH				none~ ()~~0.00~In Patient		1						1	Arthralgia; Grip strength decreased; Injected limb mobility decreased; Injection site pain	FLU3~SANOFI PASTEUR~42744AA~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333679	12/02/2008	IA	53.0	53		F	12/02/2008	(L) arm sore since receiving FLUZONE 10/28/08. Started getting sore the evening she got shot. No redness or swelling. Ultrasound negative for hematoma. Prednisone gave little relief. Ibuprofen takes edge off.				Y					U	10/28/2008	10/28/2008	0	Ultrasound negative for hematoma.	PVT	PVT	LIPITOR	None	None			1						1	Pain in extremity; Ultrasound scan normal	FLU3~SANOFI PASTEUR~U2789DA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333681	12/02/2008	IL	66.0	66		M	12/02/2008	Called to report hives to his chest, back and face.  Breathing DK at 6:30 pm 12-2-8.  No reaction at injection sites.  Pt. stated he has severe prostate issues.  I told him to call his PCP.  MD told him to take a few doses of BENADRYL & go to ER if no improvement.  Phoned Pt wife 9 pm she gave 1 dose BENDRYL.  He is improving quickly.									Y	12/02/2008	12/02/2008	0		OTH	PVT		No	No	No~ ()~~0.00~In Patient		1						1	Prostatic disorder; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0867X~1~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0333683	12/02/2008	AZ	51.0	51		F	12/02/2008	EE received FLUZONE on 10/30 around 12 noon. EE states noted hot flashes to face with 3 hrs of injection, noted rash on neck and cheeks 2 days after injection 11/1/08. Reported this to nurse on 11/2/08 rash felt hot, self treated with cold compresses. States rash took 1 1/2 weeks to dissipate.									Y	10/30/2008	10/30/2008	0	None	OTH	PVT	venavaccine; anti depressant; synthroid	None	Hypothyroid; Depression			1						1	Hot flush; Rash; Skin warm	FLU3~SANOFI PASTEUR~U2740AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333684	12/02/2008	SC	6.0	6		F	12/02/2008	Onset of symptoms 11/20/08 - Present seen in ER 11/28/08 diagnosed with Henoch Schonlein purpura. Symptoms included small papable purpura on legs and buttocks. 12/30/2008 MR received for ER visitfor c/o rash. Dx:  Henoch-Schonlein Purpura. Pt presented with 1 wk hx of macular rash on legs and buttocks.				Y					U	11/19/2008	11/20/2008	1	Complete blood count, basic metabolic profile urinalysis Labs: Platelets 371K.	PVT	PUB	None	None	Allergic to Zithromax. PMH: Allergy to Zithromax			1						1	Full blood count; Henoch-Schonlein purpura; Metabolic function test; Urine analysis	FLUN3~MEDIMMUNE VACCINES, INC.~500559P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0333686	12/02/2008	CA	68.0	68		F	12/02/2008	With in 2 hours of receiving vaccine, felt like a tight vice around my waist, and abd. large and distended; very achy. Restless night, mild nausea, H/A this AM, mild.									Y	12/01/2008	12/01/2008	0	None	PUB	UNK		None	Hysterectomy on 11-11-08 2 hour hyperplasia			1						1	Abdominal distension; Headache; Nausea; Pain; Restlessness	FLU3~SANOFI PASTEUR~U2761AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333687	12/02/2008	NY	53.0	53		F	12/02/2008	At 1:30pm three hours after flu shot was administered I began to wheeze and cough (similar to asthma attack) I went to speak to head nurse form hospital who was still at my place of employment. She said if I was not allergic to eggs or chicken to call my doctor.  I called doctor's office and explained.  They called in a prescription for ALBUTAROL (haven't needed it for two yrs.)  In the evening I had a temp of 101, shivering, flu like symptoms (severe)										11/20/2008	11/20/2008	0		UNK	OTH	ZETIA;  LEVROTHYODINE;  SINGULAR;  NORVASE;  ALTACE; LIPTOR;  HYDROCHLORIDE; LEVAZZA	None	Hypertension;  hyperlipidermia;  thyroid;  psoriatic arthritis;  asthma			1						1	Body temperature increased; Chills; Condition aggravated; Cough; Influenza like illness; Wheezing	FLU3~SANOFI PASTEUR~U2847AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333709	12/03/2008	IN	13.0	13		M	11/20/2008	Petechial rash started 7 days after flu shot.  Dx with ITP.  12/17/2008 MR received for DOS 11/17-18/2008 with DX:  ITP. Pt presented several day hx of rash and bleeding lesions.  Petechial rash and bruising noted on lower extremities, small sclera bleed, and lip bleeding on PE.  Treated with WinRho and developed vomiting H/A and chills which resolved.  D/C to f/u as outpt.					Y	1			Y	11/08/2008	11/15/2008	7	Will need monthly CBC until platelets WNL. Labs and diagnostics:  CBC with platelet count of 2.0 on admission.	OTH	PVT	None		None. PMH: none noted			1						1	Full blood count; Idiopathic thrombocytopenic purpura; Petechiae; Platelet count decreased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881293P~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0333710	12/03/2008	CA	47.0	47		M	11/20/2008	Guillain-Barre Syndrome, plasma exchange and intravenous immunoglobin.  1/12/09 Reviewed hospital D/C summary for 11/8-12/18/2008. FINAL DX: quadriplegia secondary to GBS, may be assoc w/flu vaccine; respiratory failure s/p intubation & tracheostomy; dysphagia s/p PEG tube placement; severe functional decline secondary to GBS; vegetative s/p GBS; constipation secondary to narcotic use; altered level of sensorium secondary to GBS.  1/9/08 Reviewed hospital medical records of 11/08-12/18/2008.  Neuro consult states post-vaccination acute demyelinating polyradiculopathy.  Quadriparesis secondary to GBS.  Records reveal patient experienced bilateral leg weakness, ?GBS, severe multi-joint pain, increased LFTs & r/o autoimmune disease. Had flu symptoms after flu shot, improved, then symptoms recurred withapprox 4-5 days prior to admit with weakness, fatigue, fever, decreased appetite, weight loss, tingling in extremities, dificulty standing/walking.  Had flu shots every year w/o problems.  Seen by PCP after ER visit on 11/8 as he continued to worsen & then direct admitted.  Neuro consult done & initially WNL.   GI consult done & dx w/acute viral hepatitis syndrome.     Rheum consult done & dx w/polyarticular arthralgia.  ID consult done & dx w/viral syndrome.  Cardio consult done & w/w. abnormal EKG, viral syndrome r/o cardiomyopathy.  Tx w/steroids & initially improved.  Became areflexic & LP done. Dx w/GBS.  Tx w/IVIG x 7 days.  Developed respiratory distress, intubated, ICU.  Tx w/plasmapheresis x 5 days.  Failed vent weaning & was trached & had PEG feeding tube on 12/3. Progressed slowly & d/c to inpatient rehab hospital.  8/25/09 Received hospital d/c summary of 5/4-5/8/09. FINAL DX: quadriplegia secondary to GBS, improving.  Now UE motor function 4/5, LE motor function 2/5; hx of GBS 10/08; painful dysesthesias of all extremities; narcotic dependence; hx of HTN. Records reveal patient had been tx w/high dose narcotics for pai management while in acute care & when transferred to SNF, meds were not available immediately.  Pt developed excruciating pain & full blown narcotic withdrawal & had to be admitted to acute care hosp for pain management & withdrawal control.  While there, PICC line d/c & transitioned to oral meds by pain mgt  & neuro consult.  Transferred to inpatient rehab facility to continue therapy, bowel regimen, & pain med wean.  1/9/08 Reviewed ER records of 11/6/2008. FINAL DX: chest wall pain & viral syndrome Records reveal patient experienced chest & abdominal pain, weakness, dizzy & flu symptoms of HA cough fever & chills, right shoulder pain, numbness & tingling of hands & feet x 2 days.  Improved & d/c to home. 9/28/09 D/C summary received for date of service 12/30/08 to 5/3/09.  Admit and D/C DX: GBS, facial dermatitis, UTI, Urinary retention.  8/25/09 Received hospital d/c summary of 5/4-5/8/09. FINAL DX: quadriplegia secondary to GBS, improving.  Now UE motor function 4/5, LE motor function 2/5; hx of GBS 10/08; painful dysesthesias of all extremities; narcotic dependence; hx of HTN. Records reveal patient had been tx w/high dose narcotics for pain management while in acute care & when transferred to SNF, meds were not available immediately.  Pt developed excruciating pain & full blown narcotic withdrawal & had to be admitted to acute care hosp for pain management & withdrawal control.  While there, PICC line d/c & transitioned to oral meds by pain mgt  & neuro consult.  Transferred to inpatient rehab facility to continue therapy, bowel regimen, & pain med wean./ss  9/28/09 D/C summary received for date of service 12/30/08 to 5/3/09.  Admit and D/C DX: GBS, facial dermatitis, UTI, Urinary retention,  PMH: GERD, Depression, Respitory failure, Dysphagia, Clostridium difficile.    bhp  9/28/09 Received hospital D/C summary for 12/19-12/24/2008. FINAL DX: supraventricular tachycardia & fever Had been transferred to rehab w/trach & PEG & continued pain management issues.  While in rehab developed tachycardia 170-180 & fever 100.8.  Transferred fo acute care for management.  Progressed well & d/c back to inpatient rehab./ss  9/28/09 Received rehab D/C summary for 12/30-5/3/2009. FINAL DX: Guillain-Barre syndrome Record reveals that patient had slow but steady improvement w/improved pain control & muscle function.  Co-morbidity included: UTI, urinary retention, HTN, GERD, depression, anxiety, c-diff colitis, respiratory failure w/weaning from vent & trach d/c, dysphagia w/weaning off PEG to regular PO diet./ss  9/28/09 Received hospital D/C summary for 12/19-12/24/2008. FINAL DX: supraventricular tachycardia & fever Had been transferred to rehab w/trach & PEG & continued pain management issues.  While in rehab developed tachycardia 170-180 & fever 100.8.  Transferred fo acute care for management.  Progressed well & d/c back to inpatient rehab./ss  9/28/09 Received rehab D/C summary for 12/30-5/3/2009. FINAL DX: Guillain-Barre syndrome Record reveals that patient had slow but steady improvement w/improved pain control & muscle function.  Co-morbidity included: UTI, urinary retention, HTN, GERD, depression, anxiety, c-diff colitis, respiratory failure w/weaning from vent & trach d/c, dysphagia w/weaning off PEG to regular PO diet./ss  10/13/09 PCP and D/C summaries services dates 5/8/09 to 6/27/09. Assessment: Guillain-Barre syndrome, resolving quadraparesis, respiratory failure and intubation, pain upper and lower extremities with dysethesias and hypersensitivities, musculoskeletal and smooth muscle spasms, deficits in self-care and mobility.  Patient was initially admitted to a hospital, tracheostomy required, gastrostomy tube placed. Sent to rehabilitation center for continued medical and subacute management, weaned off ventilater, transferred to another facility for further therapy and pain management. Can ambulate with walker, wheelchair used for long distances. Patient is being discharged home with his wife. Continued therapy provided by home health and on outpatient bases.			Y	Y	Y	230	Y	Y	U	10/24/2008	10/30/2008	6	Clinical diagnosis - spinal tap symptoms, vaccine.  11/6 ER LABS: CSF: protein(H).  SGOT 135(H), SGPT 215(H).  ESR 8(N).  Myoglobin 30.  CXR & EKG WNL.    Hospital LABS: SGOT 101(H), SGPT 202(H), ALP 124(H), sodium 134(L), LDH 545(H).  Lymphs 45%(H), monos 11%(H).  D-Dimer 2.35(H).	OTH	UNK		None	Seasonal allergies; High blood pressure; High cholesterol  PMH:HTN, anxiety, pedal edema, high triglycerides, GERD, photosensitivity, resolved petechial rash.  Allergy: statins(myalgias).  Family hx: heart disease. 9/28/09 D/C summary received for date of service 12/30/08 to 5/3/09.  PMH: GERD, Depression, Respitory failure, Dysphagia, Clostridium difficile.  10/13/09 PCP and D/C summaries services dates 5/8/09 to 6/27/09. PMH: Over-medication with narcotics, hypertension, left rotator cuff surgery, bilateral cataract surgery.			1						1	Blood product transfusion; Guillain-Barre syndrome; Lumbar puncture; Plasmapheresis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA207AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0333717	12/03/2008	CA	56.0	56		F	10/29/2008	Started with tingling in face-right side of tongue and throat started feeling swollen-then felt pressure in (L) ear. -> Took BENADRYL 50 mg at 0900 and then 1300 but symptoms had resolved. Vitals WNL									Y	10/27/2008	10/27/2008	0	None	OTH	PUB	LIPITOR; Synthroid	None	High cholesterol			1						1	Ear discomfort; Paraesthesia oral; Pharyngeal oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~191AA~1~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0333718	12/03/2008	IA	56.0	56		M	11/10/2008	Severe body aches & pains.  Chills & sweats. Headache. Extreme fatigue. Slight sore throat. Suspect slight fever, but did not measure. Onset = 18hr after vaccine duration = 3 days.									Y	11/05/2008	11/06/2008	1	None	OTH	UNK	None	None	None	Similar to patient~Influenza (Seasonal) (no brand name)~1~53.00~Sibling		1						1	Chills; Fatigue; Headache; Hyperhidrosis; Oropharyngeal pain; Pain	FLU3~SANOFI PASTEUR~U2771AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333719	12/03/2008	IA	54.0	54		F	11/11/2008	Headache, overall aches, nausea - 8hrs after lasted about - 30hrs.									Y	10/28/2008	10/28/2008	0	None	OTH	UNK		None				1						1	Headache; Nausea; Pain	FLU3~SANOFI PASTEUR~U2771AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333721	12/03/2008	VA	67.0	67		F	12/03/2008	Developed double vision, weakness and unsteady gait on 11/13/08 and was admitted to Hospital. History of URI for 2 days with cough. CVA was r/o by MRI and CT. Transferred to Hospital on 11/17/08 and diagnosed with GBS - Miller Fisher variant. Given IV Ig. Discharged 11/25/08 to Rehab. Still requiring maximum assistance and still with blurred vision and diplopia. 12/04/08-records received for DOS 11/18-11/25/08-DC summary not available. Prsented with C/O numbness to upper extremities progressing upwards and blurred vision. Unable to stand. Numbness descending. IVIG treatment.					Y	8			N	10/20/2008	11/13/2008	24	CT- mild ischemic changes in white area but no changes in gray matter. No MRI evidence of CVA or demyelenating lesions. Central disc herniations seen. Abnormal nerve conduction study consistent with proximal demyelinating type of neuropathy, consistent with GBS. 12/4/08-records received-Electrodiagnostic studies abnormal nerve conduction consitent with proximal demyelingating type of neuropathy consistent with early Guillain-Barre disease. Chest-x-ray low chest volume. MRI spine normal. Vensous doppler normal of upper and lower extremities. CSF results not available. 1/2/09-records received-1/2/09-records received -EMG report normal motor and sensory nerve conduction study. No H reflex bilaterally. Multiple axonal reflex potential of tibial nerves. Normal F was. Normal EMG of both legs. Impression Probably early demylenating neuropathy consistent with Guillain Barre disease Miller Fisher varient. CSF protein 41, glucose 92, WBC 6.	UNK	UNK	Mazide, HCTZ for HTN	None	Osteoporosis 12/4/08-records received- PMH:hypertension.			1						1	Asthenia; Blood product transfusion; Computerised tomogram abnormal; Cough; Diplopia; Gait disturbance; Guillain-Barre syndrome; Miller Fisher syndrome; Nerve conduction studies abnormal; Nuclear magnetic resonance imaging normal; Upper respiratory tract infection; Vision blurred; Abasia; Asthenia; Ataxia; Blood product transfusion; Diplopia; Diplopia; Dysarthria; Guillain-Barre syndrome; Lumbar puncture; Nasopharyngitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88636~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88636~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Hospitalisation	Influenza
0333725	12/03/2008	NY	32.0	32		F	12/03/2008	Extreme bilat eye redness and swelling with purulent drainage. Asthma attack, coughing, trouble swallowing.									Y	11/21/2008	11/21/2008	0		PVT	PVT			latex, prednisone, asthma,IC, acid reflux, environmental allergies, animal dander allergies			1						1	Asthma; Cough; Dysphagia; Eye discharge; Eye swelling; Ocular hyperaemia	FLU3~SANOFI PASTEUR~u2849ac~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333726	12/03/2008	SC	3.0	3		M	12/03/2008	Patient was 3 year old male with known history of asthma.  Parent provided documentation to day care informing them not to allow him to receive the intranasal flu vaccine due to contraindications and guidance from child's pediatrician.  During the schools annul flu vaccine program, the patient was given the intranasal vaccine.  As a result, the patient's mother has self reported moderate subsequent symptoms of headache and runny nose.  At this time, the patent has not sought medical care to address the symptoms noted above.									Y	11/14/2008	11/15/2008	1	none	UNK	UNK	Albuterol, Flovent, Aquaphor		Asthma			1						1	Headache; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~US493AA~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0333731	12/03/2008	IN	1.28	1	.3	F	12/03/2008	11/28 - went in for 15 month visit.  She had been congested for a couple of days, but no fever.  She was given the pneumococcal conjugate vaccine, the diphtheria tetanus & pertussis vaccine and a flu shot. She was running a low grade fever on Friday.  By Saturday afternoon, temp was running high 102's.  We called clinic who told us probaby just from vaccines, but if did not go away by Sunday to come in.  Sunday still high 102's - was giving Tylenol every 4 hours which was not reducing it at all, stopped drinking fluids.  Took to clinic around 6 pm - they told us to try alternating the Tylenol w/Ibuprofen.  Gave her Ibuprofen around 8 pm and she had a seizure at 10 pm.  She was sitting on my lap watching Elmo and had laid her head down on my lap when I heard a gurgling sound.  I pulled her back and her eyes rolled back in her head and her body was stiff.  She did not shake at that point.  She didn't appear to be breathing.  My husband grabbed her and took her our neighbor, who is a nurse.  I called 911 and went to nbr's house.  She said she was turning purple, not breathing, seizing, and said her head and maybe arms were shaking.  She said her heart was beating, but wasn't breathing so gave her some breaths.  It seems like it lasted around 5 to 10 mins.  She just started coming out of it when the EMT's got here.  They put an oxygen mask on her when they got her and took to ER. 12/04/08-records received for DOS 11/30/08-presented to ED with fever and febrile seizure became unresponsive. Decreased oral intake and decreased urine output. Fussy and crying. Overnight observation.				Y	Y	1			Y	11/28/2008	11/30/2008	2	All blood test/cultures, EEG, UTI test came back normal.  Dr's said they thought she probably had a virus. 12/04/08-records received-LabWNL	UNK	UNK		Congested - dr said probably just a virus. 12/4/08-records received-At time of vaccination had some congestion.	Born w/cord around neck, but recovered pretty quickly.  Had a fever so admitted to NICU to make sure no infection - all tests came back fine.  Did have a heart murmur, but by 1-2 weeks old, it was gone.  Around 2 mos of age had a swallow study done which showed she was aspirating slightly.  She hasn't had any more problems since.			1						1	Apnoea; Blood culture negative; Blood test normal; Convulsion; Electroencephalogram normal; Fluid intake reduced; Gaze palsy; Musculoskeletal stiffness; Pyrexia; Skin discolouration; Tremor; Urine analysis normal	DTAP~UNKNOWN MANUFACTURER~unknown~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U2005AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~D06803~UNK~UN~UN~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0333732	12/03/2008	IL	2.0	2	.3	M	12/03/2008	Rash, similar to hives, 24hrs after administration of first Fluzone vaccine									Y	10/29/2008	10/30/2008	1	none	PVT	PVT	none	none	none			1						1	Rash	FLU3~SANOFI PASTEUR~U2759AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333733	12/03/2008	PA	55.0	55		F	12/03/2008	I am experiencing continued pain in upper arm and shoulder.  I can't lift my arm above my head without searing pain.									N	10/09/2008	10/10/2008	1		PVT	PVT	Topomax, Trazadone, Lexapro, Achipex	None	Fibromyalgia, arthritis, asthma,Gerd			1						1	Injected limb mobility decreased; Musculoskeletal pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0333736	12/03/2008	IL	66.0	66		F	12/03/2008	Patient received flu vaccination in left arm.  Immediately began itching within a few minutes....the next day arm began to be red. She didn't take anything and let it run its course.  She asked what strains the flu vaccine covered and I gave her the information and mailed her a copy.									U	10/25/2008	10/25/2008	0	Unknown	UNK	UNK	Unknown	Unknown	Unknown			1						1	Erythema; Immediate post-injection reaction; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA185AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0333737	12/03/2008	CT	52.0	52		F	12/03/2008	Patient received the flu shot on 10/22/08.  Felt pain at the site.  A few days later pain continued at injection site.  Saw PCP.  Referred to specialit who diagnosed her 10 days later with neuritis.  Had physical therapy.				Y					U	10/22/2008	10/23/2008	1		PUB	PVT						1						1	Injection site pain; Neuritis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88910~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0333739	12/03/2008	IL	56.0	56		F	12/03/2008	Patient received flu vaccination in left arm.  Patient says she started to get a red knot the size of a baseball , hot and itching.  She didn't experience problems until day after flu shot.  She didn't seek medical attention, she called the Director and called healthcare center. We advised her to contact the physician if further problems.									Y	10/31/2008	11/01/2008	1	Unknown	UNK	UNK	Unknown	Unknown	Unknown			1						1	Erythema; Induration; Pruritus; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLA185AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0333741	12/03/2008	NJ	64.0	64		M	12/03/2008	On 11/3, recieved influenza vaccine.On approx 11/21, presented with signs of an upper respiratory tract infection with cough,mucus, and sore throat.  He was started on amoxicillin.On 11/28, pt became weak in the legs and had trouble walking.  On 11/29, he was crawling around the house as he could not walk due to weakness.  He was admitted to the hospital on 11/30 with dx Guillian-Barre. He is presently in Intensive Care receiving IVIG 1/22/09-records received for DOS 11/30-12/26/08. DC DX:Guillain Barre Syndrome. Pulmonary embolus. Transaminitis. Hypertension. Presented with developing progressive parapersis and weakness of upper and lower extremities to point unable to walk around and began crawling. Treated with IV gamma globulins. Developed acute pulmonary embolus.			Y	Y	Y	26			U	11/03/2008	11/28/2008	25	EMG-Positive for Guillian-Barre 1/22/09-records received-Elevated liver function test. CT scan and ultrasounds negative. Electrodiagnostic testing revealed a servere acute sensory motor polyneuropathy. Troponins elevated. CSF protein 87, CSF monocytes elevated 88. WBC 4.0	UNK	UNK		No 1/22/09-records received-upper respiratory infection about a week prior	History of hypertension otherwise healthy.Allergic to crawfish-rash.No known drug allergies 1/22/09-records received-PMH:hypertension.			1						1	Blood product transfusion; Electromyogram abnormal; Gait disturbance; Intensive care; Muscular weakness; Oropharyngeal pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89750~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0333746	12/03/2008	TX	60.0	60		F	12/03/2008	Client called and stated she had difficulty breathing with wheezing started in the even after receiving the flu shot.  She stated that she also broke out in hives and rash the following day.				Y					Y	11/17/2008	11/17/2008	0		UNK	UNK	Simvascacin 20 mg.	none	none			1						1	Dyspnoea; Rash; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U2810 AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333747	12/03/2008	NH	62.0	62		M	12/03/2008	Received Afluria Influenza Vaccine on Sunday, Nov 2, 2008. On Thursday, November 6, I began feeling ill. I developed a full blown case of the flu with fever, chills, aches, respiratory symptoms etc.  By the beginning of the following week I was unable to go to work.  I AM RARELY SICK & NEVER MISS WORK. I was really sick.  Since this reaction I have heard other anedotal stories of more than a few people getting the flu within a week after receiving a flu shot. I will not get a flu shot in the future and I wanted the reaction reported!									Y	11/02/2008	11/06/2008	4	N/A	UNK	UNK	None other than a multivitamin	None	None			1						1	Activities of daily living impaired; Chills; Influenza; Malaise; Pain; Pyrexia	FLU3~CSL LIMITED~~UNK~UN~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0333748	12/03/2008	IL	56.0	56		M	12/03/2008	I received the Flu vaccine at 11:00am-felt fine all day. At 7:00pm I was at home-began getting chills. abd felt feverish. By 9:00pm temperature was 102.9. Used ice pack on forehead, cold washcloth on my chest, back, and neck and by 11:15pm fever was down below 100 and the next day I was fine.									Y	11/26/2008	11/26/2008	0		PVT	PVT	Propecia, Allupurinol. Cochicine, Omeprazole	None	None			1						1	Chills; Feeling hot; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0333753	12/03/2008	CA	66.0	66		F	12/03/2008	This case was reported by a healthcare professional and described the occurrence of feeling sick in a 66-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included CRESTOR, ALLEGRA D, FEMARA and RECLAST. On 3 November 2008, the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). On 4 November 2008, one day after vaccination with FLULAVAL, the subject experienced feeling sick, feel flu like, fever, body pain, and gastroenteritis. At an unspecified time after vaccination with FLULAVAL, the subject experienced possible kidney problems, heaviness in eyelid, lower left quadrant pain, night sweat and pharmaceutical product complaint. The subject received a dose of FLULAVAL and one day later reported feeling like she had the flu. She reported gastrointestinal (GI) symptoms, which the physician noted as gastroenteritis. Labs were performed at the healthcare providers once on 01 December 2008, white blood cell (WBC) count was elevated and platelets elevated. Physician reported a decrease in hemoglobin from 12.7 to 9.4. Physician questions whether there was also kidney function involvement due to casts and red blood cells in urine. Other adverse events reported were bone aches, eyelids feel heavy, left lower quadrant pain and night sweats. Blood cultures were done today (02 December 2008) after the results of elevated WBC. The physician also referred the subject to an infectious disease doctor. Physician was questioning remainder to product since all from same lot number. The healthcare professional considered the events were disabling. At the time of reporting the outcome of the events were unspecified. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.				Y				Y	U	11/03/2008	11/04/2008	1	Hemoglobin, 01Dec2008, 9.4; Hemoglobin, 12.7; Platelet count, 01Dec2008, elevated; White blood cell count, 01Dec2008, elevated; 01 December 2008: casts and red blood cells in urine; 02 December 2008: Blood cultures were taken.	PVT	PVT	Rosuvastatin calcium; HYZAAR; ALLEGRA-D; Letrozole; Zoledronic acid	Unknown	The subject had previously received influenza vaccinations and no adverse events were reported. No adverse events were reported following receipt of prior immunizations.		A0758980A	1						1	Abdominal pain lower; Asthenopia; Blood culture; Blood urine present; Bone pain; Gastroenteritis; Haemoglobin decreased; Influenza like illness; Malaise; Night sweats; Pain; Pharmaceutical product complaint; Platelet count increased; Pyrexia; Urinary casts present; White blood cell count increased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA185AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Disabling	Influenza
0333757	12/03/2008	NH	16.0	16		F	11/21/2008	A serious spontaneous report of passed out, increased heart rate, shaking, feeling tired, lethargy, headache, feels cold, chills, and nausea has been received from a consumer concerning a 17-year-old female subsequent to FLUMIST. Neither past medical history nor concomitant medications have been reported. The patient received FLUMIST on 31-Oct-2008. One week after receiving FLUMIST, the patient started feeling tired and having headaches. On 09-NOV-2008, the patient passed out while at work and paramedics transported her to the hospital. She had symptoms of increased heart rate and lethargy. While at the ER, all tests were normal and the patient was released. The following week, the patient still felt tired, reported feeling cold, had chills with shaking and nausea. The patient was taken back to the physician on 20-Nov-2008 who indicated that the patient could be experiencing stress and gave her something for her stomach. The outcome was not reported.									U	10/31/2008	11/07/2008	7		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007542	1						1	Chills; Fatigue; Feeling cold; Headache; Heart rate increased; Lethargy; Loss of consciousness; Nausea; Tremor	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0333759	12/03/2008	PA	0.6	0	.6	M	11/28/2008	5 days after vaccines administered pt was found face-down in crib not breathing. Resuscitation not successful. No other signs of illness. Presumed SIDS vs suffocation.  3/9/09-autopsy report received-COD Sudden Infant Death Syndrome.	Y	11/26/2008							N	11/21/2008	11/26/2008	5	None	PVT	PVT	Zantac	Minimal URI	Snoring per ENT; No sleep apnea; GERD 3/9/09-records received-per parent patient suffered from sleep apnea from birth and sometimes snore when sleeping. Antibiotic therapy for recent throat problem. Born 4 weeks premature.			1						1	Apnoea; Death	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B198AA~3~UN~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U22787CA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~D03125~3~UN~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~09688~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Results in Death	Influenza
0333760	12/03/2008	CT	36.0	36		M	12/02/2008	11/16/08 developed numbness tingling saddle area.  Saw primary care Physician 11/20.  Numbness, tingling progressed to lower extremities.  Difficulty walking, admitted to hospital. 1/8/09-records received for DOS 11/21-11/26/08-DC DX: Acute autoimmune myelitis. Presented to ED with C/O bilateral calf pain and leg pain. Passing gas uncontrollably. Anus and penis numb, urinating problems. Calf pain and numbness. Received flu vaccine 11/9/08.					Y	5			Y	11/09/2008	11/16/2008	7	MRI at hospital while patient. 1/14/09-records received-CSF protein elevated 65, nucleated cells increased 13, lymphocytes increased, monotcytes increased. CSF culture negative.MRI demonstrated disc protrustion. Treated with IVIG. MRI likely represents demyelination.	OTH	PVT	None	None	Seasonal Allergies		CT200814	1						1	Gait disturbance; Hypoaesthesia; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~892975P~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0333762	12/03/2008	OH	58.0	58		F	11/11/2008	Flu vaccination on 11/6 - 11/9 -> developed B1ell's palsy. 12/22/08-records received for ED visit 11/7/08-C/O foot pain status post injury 11/6/08. Pain with walking. PE: rhinorrhea.  Assessment right ankle contusion. Edema. no record of hospitalization.				Y					U	11/06/2008	11/07/2008	1		UNK	UNK			10/22/08-records received-PMH: HTN and CAD. Allegies to latex, penicillins, shellfish and iodine.			1						1	Facial palsy	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0333763	12/03/2008	NC	8.0	8		M	11/19/2008	Child 5 years old usually walks at night time past 3-4 weeks 90 minutes. After going to sleep gets up, screams, panic sweats, eyes wide open and non responsive. When wakes up does not remember anything.  Starting to be very tired every morning since this has gone on so long.									U	10/28/2008			None	PUB	PUB	None	None	Hay fever allergy		NC08113	1						1	Fatigue; Hyperhidrosis; Memory impairment; Panic reaction; Screaming; Unresponsive to stimuli	FLU3~SANOFI PASTEUR~U2828AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333766	12/03/2008	MA	1.14	1	.1	M	12/03/2008	Left upper arm cellulitis - Swollen, red, warm site of HepA vaccine. Treated with KEFLEX 250mg/5ml BID for 7 days.				Y					Y	11/24/2008	11/25/2008	1		PUB	PUB	PPD					1						1	Injection site cellulitis; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2800BA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAB239AA~2~IM~LA~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1247X~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C40031~5~IM~RA~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1222X~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0333767	12/03/2008	AR	11.0	11		F	12/03/2008	3 cm circular area of redness and warmth with induration, 2 days post injection- Rx BACTRIM DS tab bid x 7 days, BENADRYL 25-50 mg q 6-8 hrs prn.				Y					Y	12/01/2008	12/03/2008	2		PVT	PVT	MOTRIN					1						1	Erythema; Induration; Skin warm	FLU3~SANOFI PASTEUR~U2745AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2755AA~1~IM~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~0791x~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0333768	12/03/2008	NC	53.0	53		M	10/29/2008	Rec. Vac. 4pm 10/15/2008.  At approx 8pm started having a cough with some wheezing (mild).  At 10:30pm upper lip became swollen and numb.  By 12 mn had extreme eye redness, fever, chills & generalized aches.  It resolved without treatment in 24 hrs.  Yrs. ago, had 1 episode of fever & chills 8 hr after flu vac which resolved overnight.  0 food allergies. Did not eat evening of 10/15/2008.									Y	10/15/2008	10/15/2008	0		PUB	PVT		None		See Above~ ()~~0.00~In Patient		1						1	Chills; Cough; Hypoaesthesia oral; Lip swelling; Ocular hyperaemia; Pain; Pyrexia; Vaccine positive rechallenge; Wheezing	FLU3~SANOFI PASTEUR~U2748AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333771	12/03/2008	NY	56.0	56		F		Pt. called and reported he had a reaction to the flu vaccine that he received on 11/24/08. Stated he had a bad headache and was disoriented. He had to leave work and went home to bed, and did not wake until next AM. Stated he felt fine the day he called on 11/25/08.									Y	11/24/2008	11/24/2008	0		PVT	OTH						1						1	Disorientation; Headache; Hypersomnia	FLU3~SANOFI PASTEUR~U2739AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333772	12/03/2008	OK	5.0	5		F	11/26/2008	Site reaction, area swollen and tender. No treatment.									Y	11/24/2008	11/26/2008	2		PVT	PUB	CLARITAN; SINGULAIR		Allergic rhinitis			1						1	Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~UT2P14CA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333773	12/03/2008	CA	16.0	16		F	12/03/2008	3 - 5 min. after vaccines (HPV,flu shot, TST) client felt a warm flush, passed out and slid to the floor from her chair, bumped head RT side - no swelling.									Y	12/03/2008	12/03/2008	0	None	PUB	PUB	None - denies	Migraine	Denies			1						1	Head injury; Hot flush; Loss of consciousness	FLU3~SANOFI PASTEUR~U2806AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0843X~1~UN~RA~HPV (GARDASIL)~1|UNK~UNKNOWN MANUFACTURER~62878~2~UN~LA~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA		Influenza
0333775	12/03/2008	PA	67.0	67		M	12/02/2008	Immediately after receiving flu vaccine got headache and metallic taste in mouth. No further problem. Took Tylenol for headache.									Y	11/12/2008	11/12/2008	0		OTH	PUB		None	Gluten intolerance			1						1	Dysgeusia; Headache; Immediate post-injection reaction	FLU3~SANOFI PASTEUR~HU2748AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333776	12/03/2008	NC	73.0	73		M	11/24/2008	muscle ache with spasm like feeling @ injection site.  Zero redness.  Zero swelling.  Advised alternating warm/cold compress with IBUPROFEN.  Call after 1 week if zero better.									Y	10/27/2008	10/28/2008	1	None	PUB	PVT	None	None	None		NC08114	1						1	Injection site reaction; Muscle spasms; Myalgia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~U2764AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333750	12/04/2008		30.0	30		F	12/04/2008	Started with nasal conjestion; fever & chills; malaise; vomited X 1 mucus; general feeling bad;  Face& sinus area swollen under eyes; lips peeling;  eyes - light sensitive; Went to local emergency room - received medication consisting of Amoxicillin, Zyrtec, Ibuprofen. Felt better for 1 day and then vomited X 3 and had fever & chills - stopped medications.  Saw Regional Medical Doctor.  Patient was off work 4 days. Patient states she will never get another flu vaccine.				Y					Y	11/26/2008	11/27/2008	1		UNK	UNK		none known	none known			1						1	Activities of daily living impaired; Chills; Feeling abnormal; Lip exfoliation; Malaise; Nasal congestion; Photophobia; Pyrexia; Swelling face; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500567P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0333837	12/04/2008	IN	36.0			F	12/01/2008	Initial report received on 24 November 2008 from a health care professional. A 36-year-old female patient (date of birth not provided), who denied any concurrent illnesses, and who has a past medical history of asthma, had received an intramuscular left deltoid injection of FLUZONE SV 2008-2009 (lot number U2747AA) on 19 November 2008 at 15:05 pm. Twenty minutes after receiving the FLUZONE vaccine, the patient experienced severe wheezing, facial swelling, increased heart rate to 155 beats/minute and she was diaphoretic and had severe nausea and vomiting. She was also shaking and felt dizzy and tingly. The patient was evaluated by the vaccine provider (not identified) less than five minutes after receiving the vaccine and was given epinephrine (route not provided). Emergency Medical Team was called and the patient was transported to the hospital emergency room by ambulance. It was not reported whether any relevant diagnostic tests/laboratory data were performed. At the time of this report, the vaccine provider reported that the patient was recovered and back to work (dates not provided). Documents held by sender: None.				Y					Y	11/19/2008	11/19/2008	0	None reported	OTH	OTH	ALBUTEROL		The patient did not report any illnesses, but did have past medical history of asthma at the time of the vaccination on 19 November 2008.  The patient has received several influenza vaccines in the past, and it was unknown if the patient had experienced any adverse events with prior vaccinations.		200803726	1						1	Dizziness; Heart rate increased; Hyperhidrosis; Immediate post-injection reaction; Nausea; Paraesthesia; Swelling face; Tremor; Vomiting; Wheezing	FLU3~SANOFI PASTEUR~U2747A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333840	12/04/2008	MD	54.0	54		F	12/01/2008	90 mins after vaccine pt got cough, chest tightness and took BENADRYL that improved sx. Eye swollen with mild D/C. Developed next fever to 101.7 and chills. Migraine like HA with nausea and vomiting.									Y	11/26/2008	11/26/2008	0		PVT	OTH		None	TAPAZOLE, PTa			1						1	Chest discomfort; Chills; Cough; Eye discharge; Eye swelling; Migraine; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333841	12/04/2008	VA	6.0	6		F	11/18/2008	expired vaccine given									Y	11/14/2008	11/18/2008	4		PUB	PUB		None	No			1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~5000540P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0333842	12/04/2008	NY	59.0	59		F	12/01/2008	b/L UE muscle ache and soreness. 10/21/08 continues with some improvement in the LUE. No weakness no numbness Advil as needed. Vaccine administered 10/17/08 RUE.									U	10/17/2008	10/21/2008	4		PVT	OTH	LIPITOR, LISINOPRIL, ASA 81 MUL, Ca2+/VIT D		HTN, Hypercholesterolemia			1						1	Myalgia; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA181AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0333884	12/04/2008	OH	60.0	60		M	12/04/2008	Approximately 5-6 hrs post vaccination, wife of client reports that client reported facial swelling and malaise. She did not report SOB. She did state client has had flu shots in the post 5-6 years and has not had this reaction with every shot. She states He did have this reaction last year when he received a flu shot from his drs. office.									U	12/01/2008	12/01/2008	0	none reported	PUB	PVT	None reported	None reported	None reported			1						1	Malaise; No reaction on previous exposure to drug; Swelling face	FLU3~SANOFI PASTEUR~U2768AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333885	12/04/2008	KY	52.0	52		M	12/04/2008	itching rash on several areas of his body including his head, middle of his back,  under his left arm pit, stomach and groin area. Says his mouth feels and his tongue thick.  Veteran denies any shortness of breath or chest pain.				Y					Y	09/13/2008				MIL	UNK						1						1	Rash; Rash pruritic; Tongue disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA181AA~UNK~~~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0333888	12/04/2008	ND	1.5	1	.6	M	12/02/2008	Patient had large local eyrethatous patch at injection site that was raised. Patient later presented with wheezes to the ER.				Y					Y	11/24/2008	11/25/2008	1		MIL	MIL		None	None			1						1	Injection site erythema; Wheezing	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B087CA~5~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~VT27881A~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333890	12/04/2008	ND	4.0	4		M	11/26/2008	One hour after receiving vaccines patient broke out in hives.									Y	11/26/2008	11/26/2008	0		MIL	MIL		None	Asthma, A&D ung allergy			1						1	Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B087CA~5~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~v2791DA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A1109~4~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1119X~2~IM~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0789X~2~IM~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0333891	12/04/2008	IL	22.0	22		F	12/04/2008	Vaccine administered as outpatient. Next day started with fever 103F, pain 7 on a scale to 10, warmth and redness x 2 days.  Emergency room treated with Tylenol and Ancef and admitted to rule out other infection process and treat cellulitis of arm. Ancef continued and changed to Keflex at discharge.  Length of stay 3 days.  Near resolution at that time. 12/17/08-records received for DOS 9/26-9/29/08-DC DX: Probably cellulitis of right upper extremity,  possibel allergic reaction to pneumovax. Admitted with fever and chills. Injection site red, swollen hot.				Y	Y	3			Y	09/24/2008	09/25/2008	1	IgE and IgA to rule out aseptic vaccine reaction. UA, Urine and blood cultures negative to rule out other source of infection. CBC drawn twice. Echo due to congenital heart defect. 12/17/08-records received-Cultures negative. Electrolytes unremarkable. Initial white blood count 13,000. Protime elevated consistent with Coumadin status. White blood count elevated in urine.	UNK	UNK	Coumadin, Wellbutrin XL, enalapril, Topamax, lasix, DepoProvera	Discharged from hospital 2 weeks prior for bronchitis/pneumonia.	NKDA, congenital heart defect with prior open heart surgery, stroke at age 3, depression, headaches, abdominal vessel surgery at unknown age. 12/17/08-records received-congential heart disease, chronic headache, psychiatric disorder not otherwise specified, history of stroke w ith left-sided weakness			1						1	Blood culture negative; Blood immunoglobulin A; Blood immunoglobulin E; Cellulitis; Culture urine negative; Echocardiogram; Erythema; Full blood count; Pain; Pyrexia; Skin warm	FLU3~CSL LIMITED~U2746AA~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~0224X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0333894	12/04/2008	IL	89.0	89		F	12/04/2008	Patient had received a flu vaccination in left arm from flu site.  She informed a lady about 3 inches down from injection site she has a bruise and a litle firmness, no redness.... Patient contacted flu coordinator for on 10/28...was told by coordinator to continue to watch it and to contact physician if any further problems...On call back at a later time patient indicated it was better.									Y	10/27/2008	10/28/2008	1	Unknown	UNK	UNK	Unknown	Unknown	Unknown			1						1	Contusion; Induration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA185AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0333895	12/04/2008	NJ	60.0	60		F	12/04/2008	Prior to vaccination pt was on inhaler for asthma developed  hoarseness  and treating physician  (FMD) discontinued the inhaler.  Hoarseness improved and pt's doctor ok'd flu shot.                                            -Approximately one week post flu vaccination pt developed wheezing. FMD prescribed Amoxil with noimprovement.                                   - Two weeks post  flu vaccination pt developed cough, body aches, extreme fatigue and FMD prescribed  Levaquin    which helped her symptoms but seemed to have a relapse according to pt and  needed to take an additional week of    Levaquin.   Cough resolved  but up to present pt notes upper extremity aches, neck soreness and malaise.     She did note that overall she feels much better but there is residual.                                         -  Due to persistence of symptoms pt's FMD drew bloodwork today.				Y					N	10/21/2008	10/28/2008	7	chest xray:  performed by patient's personal physician.  Negative according to patient	UNK	PVT		please see #7	PT under active care for Allergies and Asthma			1						1	Blood test; Chest X-ray normal; Cough; Fatigue; Malaise; Neck pain; Pain; Wheezing	FLU3~SANOFI PASTEUR~U2784GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333897	12/04/2008	WV	34.0	34		M	12/04/2008	approx. 30-60 minutes after receiving influenza vaccine, pt. c/o feeling anxious and not right.  Had a reaction to Cipro in past and felt the same way.  Taken to ED, IV meds given.				Y					Y	12/02/2008	12/02/2008	0		PUB	PVT	none	none	cipro			1						1	Anxiety; Feeling abnormal	FLU3~SANOFI PASTEUR~U2848AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0333898	12/04/2008	SD	63.0	63		F	12/04/2008	Client recieved a flu shot at 1045 on 120308 with Sanofi Pasteur vaccine Lot number U2760AA IM in the right deltoid by a nursing student.  1415 The client returned to the flu clinic compaining of shortmess of breath and spongie legs---felt like her legs wouldn't hold her up.  Client appears pale.  Skin is warm and dry to touch.  Blood pressure is 130/80, Pulse 65 BPM, lung sounds are non congested, no wheezing or rales.  Good S1 and S2 sounds.   Denies any tightnesss or feeling of the throat swelling shut.  1422 Administered 4 liters of O2----color returned to pink.  Client indicates Dr at the clinic is her Dr.  RN called the clinic and Dr is out of the office until 010609 and advised RN to call the ER and talk to Dr.  1425 RN clled the hospital ER and spoke to RN and PA called RN back.  PA felt this client had a reaction to the flu shot and indicated some of the shortness of breath could be anxiety and wanted client to wait 30 minutes at the flu shot clinic and to have 50 mg of Benadryl IM if client wanted the Benadryl.  Client refused to have her husband or family called and requested her co worker and boss to take her home.  Benadryl 50 mg/ml given IM in the left deltoid at 1452.  O2 discontinued and client tolerated this well and denied shortness of breath, but was feeling a little sleepy.   At 1515 client was walked down to first floor per elevator with assistence of RN and her bosss.  Client indicated she was sleepy and slightly dizzy.  Client was driven home by one of her co workers.  120408 1330 Telephone call to the client's work---she is home today.   Called client at home and she indicated she slept all of yesterday afternoon and all night.  Today she feels tired, weak, and feels like she has a fever (hasn't taken temperature).  Denies any shortness of breath but does feel letharic.  RN advised client to go to clinic or ER if she has any future problms and another RN will chck on her on 120808.										12/03/2008	12/03/2008	0		UNK	UNK	Client indicates she takes a Blood pressure pill and medication for epilepsy.	Client denied any illness, although she was somewhat tired.	High Blood Pressure and Epilepsy.			1						1	Asthenia; Dizziness; Dry skin; Dyspnoea; Fatigue; Feeling hot; Lethargy; Muscular weakness; Oxygen supplementation; Pallor; Skin warm; Somnolence	FLU3~SANOFI PASTEUR~U2760AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333900	12/04/2008	MO	32.0	32		F	12/04/2008	Pt reported on 10/31/08 that she received Influenza injection on 10/30/08 at aprox 1:00pm. Pt reports that aprox 5:30pm she felt the following symptoms:eyes felt dry,vision blurry, coughing,throat felt enlarged, fever of 101 and had body aches. She took Ibuprofen and nyquill at 10:30pm on 10/30/08.  On 10/31/08 at aprox 4:00pm she took Benadryl 25mg and aprox 30 minutes later her swollen throat felt better.									Y	10/30/2008	10/30/2008	0		PUB	PVT	zanax, zolpaiem, effexor	none				1						1	Cough; Dry eye; Pain; Pharyngeal oedema; Pyrexia; Vision blurred	FLU3~SANOFI PASTEUR~U2768AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333901	12/04/2008	OH	13.0	13		M	12/04/2008	According to shot record brought by mother the patient was due for MCV. After giving vaccine it was noted in the registry that it was given on May 11, 2006. The patient recieved 2 doses.									Y	12/02/2008	12/02/2008	0	none	UNK	UNK		none	none			1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U2768AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB260AA~1~IM~LA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2670AA~2~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B030AA~6~IM~RA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1186X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0333902	12/04/2008	AR	15.0	15		F	12/04/2008	She had recieved the HPV(Gardsil)# 2 vaccine in her left deltoid, when she got home a few hours later her whole left side of her body turned red and was itchy. This lasted for a couple of hours and went away, she did not seek medical attention.									Y	11/05/2008	11/05/2008	0		UNK	PUB		NONE	ASTHMA			1						1	Erythema; Pruritus	FLU3~SANOFI PASTEUR~U2797AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB297BA~2~IM~LA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~1968U~2~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0333904	12/04/2008	CO	9.0	9		M	12/04/2008	Right arm swelled from elbow to above shoulder 2 to 3 times normal.  Was hot, red, itchy and painful lasting 7 days.  Was given claritin daily for one week to help with itching.  Cold packs applied for several days.  Onset was several hours after injection.									Y	11/21/2008	11/21/2008	0		PUB	PUB		URI				1						1	Injection site erythema; Injection site pain; Injection site pruritus; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2800CA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333907	12/04/2008	WI	45.0	45		M	12/04/2008	PATIENT RECEIVED FLU-VACCINE AND DEVELOPED A RASH // MD TREATED PATIENT WITH CLARITIN DAILY FOR 5 DAYS									U	11/15/2008	11/15/2008	0	N/A	PVT	PVT		UNKNOWN	NONE			1						1	Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~UNKNOWN~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0333916	12/04/2008	NY	42.0	42		F	12/02/2008	Left facial paralysis determined to be associated with Guillain-Barre Syndrome.  01/05/2009 MR received for o/n observation 11/24-25/2008 with D/C DX: Guillain-Barre Syndome.  Facial nerve disorder. Pt presented with 4-5 hx of URI sx and malaise, which were improving, but new onset of facial paresthesia and L-sided facial weakness, drooling and slightly slurred speech. Some positional unsteadiness and R arm heaviness with funny feelings of both hands. PE (+) for L sided facial & tongue weakness as well as fluctuating facial paresthesias. Reflexes and sensation intact per neuro consult. Bells Palsy with concern for atypical GBS. D/C for outpt f/u. 1/12/2009 MR received fron neuro consult 12/17/08 with Impression-Bell's Palsy and a mild form of Guillain-Barre, both reolving. Pt seen in f/u for hospital admission. Still with c/o leg weakness, easy fatiguability, difficulty shutting L eye and some L-sided facial and jaw pain. Facial weakness improving. Some decreased sensation still present in legs up to knees. No EMG unless sx worsen.					Y	1			Y	11/19/2008	11/24/2008	5	No EMG unless sx worsen.	PVT	PVT	ADVAIR DISKUS; ALLEGRA; AVELOX; CLARINEX; CYMBALTA; FLEXERIL; FLONASE; PRILOSEC OTC; PROVENTIL HFA; tetracycline HCl; triamcinolone acetonide	None	AMOXICILLIN; SULFA. PMH: Non-Hodgkins Lymphoma in remission x 3 years. GERD.  Asthma.  Allergies-Sulfa, PCN			1						1	Facial palsy; Guillain-Barre syndrome	FLU3~SANOFI PASTEUR~U2739AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0333917	12/04/2008	CA	65.0	65		M	12/01/2008	Walking pneumonia a week later hospitalized for 4 days.				Y	Y	4			Y	11/06/2008				OTH	PVT						1						1	Pneumonia primary atypical	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89994~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1124X~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0333919	12/04/2008	IL	66.0	66		F	12/03/2008	Vaccine administered 10/30/08. Diagnosis of shingles made 11/14/08. (1) with onset of symptoms 11/6/08. (2) with onset of symptoms of rash 11/8/2008.									Y	10/30/2008	11/06/2008	7	None	PVT	PVT	CARTIA; METOPROLOL SR	None	None			1						1	Herpes zoster; Rash	FLU3~SANOFI PASTEUR~U2749AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1132U~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~1214X~1~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0333920	12/04/2008	CA	74.0	74		F		Redness, warmth, tenderness of left upper arm. Treated with antibiotic Zithromax and Prednisone.									U	12/01/2008	12/02/2008	1		PVT	UNK			COPD			1						1	Erythema; Feeling hot; Tenderness	FLU3~SANOFI PASTEUR~U2764AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0867X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0333921	12/04/2008	MT	55.0	55		F	12/02/2008	(R) shoulder pain occurred 2-3hrs after vaccination and worsened that night. No reaction noted at the injection site eythema/edema/skin rash.									U	12/01/2008	12/01/2008	0	(R) shoulder x-ray (3Vs) done 12/02/08, no acute abnormality found.	PVT	PVT	Serevent bid; Albuterol PRN	None	NKDA; Asthma; COPD			1						1	Musculoskeletal pain; X-ray normal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA375AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0813X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0333924	12/04/2008	WA	56.0	56		F	11/28/2008	11-22-08, 11-23-08, 11-24-08, seen for f/u on localized cellutitis to (R) arm inj. site. PNEUMOVAX given, IV + po antibiotics given. (TDaP + Flu)									Y	11/18/2008	11/22/2008	4		PVT	PVT						1						1	Injection site cellulitis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA357BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1161X~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2899A~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0333927	12/04/2008	RI	61.0	61		M	11/11/2008	Pt got dizzy, sweat, nauseated, and somewhat unresponsive. Called 911 due to age, nature, and ash in color. Pt did not go to hospital, came around. Later reported severe anxiety to needles.									Y	11/11/2008	11/11/2008	0	None	OTH	PUB	None	None	No Known Allergies			1						1	Anxiety; Dizziness; Hyperhidrosis; Immediate post-injection reaction; Nausea; Pallor; Unresponsive to stimuli	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8811356~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0333939	12/04/2008	GA	2.0	2	.0	M	11/26/2008	Cough and congestion for 3 weeks. No fever.									U	10/21/2008	11/12/2008	22		PVT	PVT	FER-IN-SOL	None				1						1	Cough; Upper respiratory tract congestion	DTAP~SANOFI PASTEUR~C8986AA~4~IM~RL~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500567P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|PNC~PFIZER\WYETH~C86139~2~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0333941	12/04/2008	CA	60.0	60		F	12/04/2008	L arm pain and burning									N	11/24/2008	11/24/2008	0		PVT	OTH	ZANTAC;  THYROID;  SIMUSTATIN; CELEPAM;  BITHMOL;  TRAVATAN		Deaf;  HTN;  Osteoporosis;  High cholesterol;  GERD;  Glaucoma			1						1	Burning sensation; Pain in extremity	FLU3~SANOFI PASTEUR~U2853AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0333942	12/04/2008	IN	44.0	44		F	12/04/2008	Pt received PNEUMOVAX on 12-01-08. came to the office on 12-04-08  with (R) arm red, swollen warm to touch and with fever of 101. Dr informed and recommends Benadryl, cold compress and fever reducer. F/U with Dr on 12-05-08 if no better.									U	12/01/2008	12/04/2008	3		PVT	PVT			PCN; ASA; Septra; Keflex			1						1	Erythema; Oedema peripheral; Pyrexia; Skin warm	FLU3~SANOFI PASTEUR~U2749AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0867X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0333944	12/04/2008	IN	10.0	10		M	12/04/2008	R upper arm edema, redness, tenderness.  Pt reports first noted symptoms Tues, 12-2-08 at school approximately 9am.									U	12/01/2008	12/02/2008	1	Started cellulitis treatment; AUGMENTIN; BENADRYL	PVT	PUB	None	None	None			1						1	Cellulitis; Erythema; Oedema; Tenderness	FLU3~SANOFI PASTEUR~U2849AC~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1328X~2~UN~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0333945	12/04/2008	GA	30.0	30		M	12/03/2008	developed red, raised, inflamed area at injection site. Applying Altabax 1% ointment to area twice daily for 5 days.				Y					Y	11/13/2008	11/15/2008	2	None	OTH	PVT	None	None	None			1						1	Injection site erythema; Injection site inflammation; Injection site swelling	FLU3~CSL LIMITED~01849111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0333946	12/04/2008	MN	73.0	73		F	11/20/2008	R arm red. sore									Y	11/17/2008	11/19/2008	2		PUB	UNK			Chloromycetin			1						1	Erythema; Limb discomfort	FLU3~SANOFI PASTEUR~U2804AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0867X~2~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U2348CA~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0333317	12/05/2008	CA	86.0	86		M	12/03/2008	Initial report received from a health care professional on 25 November 2008. An 86-year-old male patient with no reported medical history had received an intramuscular injection of FLUZONE SV 2008-2009, lot number U2750AA, in the left arm (also reported as the right deltoid) on 03 September 2008. On an unspecified date, possibly in September 2008, the patient developed nerve pain in the right arm. The symptoms have persisted for two months. The patient required an emergency room or doctor visit. It was not reported whether or not the patient required treatment. His recovery status is unknown. Documents held by sender: none.				Y					U	09/03/2008			Unknown	OTH	PVT	Plavix		Not reported		200803759	1						2	Neuralgia; Neuralgia	FLU3~SANOFI PASTEUR~U2750aa~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2750A~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0334017	12/05/2008	PA	1.4	1	.4	F	12/02/2008	Red swollen (R) thigh at site of vaccine.									Y	12/01/2008	12/02/2008	1		PVT	PUB						1						1	Injection site erythema; Injection site swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B066AA~4~UN~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2797EA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C37310~4~UN~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0334018	12/05/2008	UT	32.0	32		F	10/12/2008	Pt received vaccine 24hrs ago and developed nausea and vomiting for 12-24hrs and several syncopal epsoides. She presented to the Emer. Dept with clonus and tetany- type reaction but normal calcium level. She became increasingly combative and altered requiring intubation.  2/10/09 Received hospital medical records of 10/12-10/15/2008. FINAL DX: pseudoseizures Records reveal patient experienced feeling unwell, malaise, agitation, dystonia, shaking all over, staring, arching back.  Intubated to protect airway & admitted to MICU.  Did well & extubated in AM.  Referred to Psych when all tests WNL.  Meds were adjusted & d/c to home w/Psych f/u.				Y	Y	4				10/10/2008	10/12/2008	2	Scr=0.7, ca Ionized after ca gluconate 1 gram administration = 1.4 (high)  LABS: EEG WNL.  TSH (H) otherwise all labs including CSF tests WNL.	PUB	OTH	Synthroid; Celexa; Buspirone; possibly Ehidra Hr loss supply	Unknown	Hypothyroidism (due to thyroid infection) Depression Supraventicular tachycardia; Deep vein thrombosis  PMH: thyroidectomy, SVT w/ablations x 2.			1						1	Aggression; Altered state of consciousness; Blood calcium normal; Blood creatinine normal; Clonus; Convulsion; Endotracheal intubation; Nausea; Syncope; Vomiting	FLU3~SANOFI PASTEUR~AFLUA374AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0334019	12/05/2008	MA	0.5	0	.5	F	12/08/2008	6 month old without Hypotonic, Hyporesponsive Episode within 24 hrs of vaccine. Laboratory eval ER negative. Seen in ER 11/25. Episode continued 20 minutes.									Y	11/24/2008	11/25/2008	1	CBC, UA, Basic metabolic panel, urine culture, blood culture all unremarkable	PVT	UNK		None	None			1						1	Blood culture negative; Culture urine negative; Full blood count normal; Hypotonic-hyporesponsive episode; Metabolic function test normal; Urine analysis normal	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC219167AA~3~IM~LA~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~VT2788UD~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF441AA~3~IM~LA~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C31571~3~IM~RA~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0595X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0334020	12/05/2008	OR	16.0	16		F	12/01/2008	Hives started from neck to chest, started next morning after dose, and lasted 4 days. Treated with LORATADINE.									Y	11/24/2008	11/25/2008	1	None	OTH	OTH	None	Slight head congestion	Seasonal allergies; allergic Ibuprofen		0R200847	1						1	Drug hypersensitivity; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~5000563P~1~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0334026	12/05/2008	WI	45.0	45		M	12/04/2008	Information has been received from a consumer concerning her 45 year old husband with asthma and penicillin allergy who on 21-NOV-2008 was vaccinated with PNEUMOVAX 23 and influenza virus vaccine (unspecified) in the physician's office. Concomitant therapy included SIMBACOURT and LESCOL XL. On the same day, about a minute after receiving PNEUMOVAX 23 vaccine, the patient went into full blown anaphylactic shock. The patient's blood pressure went to 40/0, he did not have a pulse, his face was swollen and red, he had shortness of breath and had the shakes. Since this happened at the physician's office, the patient was kept on IV drips for 3.5 hours, given epinephrine (manufacturer unspecified), BENADRYL (manufacturer unspecified) and another steroid (name and manufacturer unspecified). Once the office gave the patient these medications, the patient's carotid pulse was good and his blood pressure came back up. The patient did not have to be hospitalized and he did not go to the hospital, but he was monitored at the physician's office and went home later that day. The physician's office gave the patient an EPI pen to take home with him. The consumer reported that the patient recovered on 22-NOV-2008. The patient went to see an allergist on 24-NOV-2008 who did some blood work. But the allergist stated that they could not test him for any allergies regarding PNEUMOVAX 23 vaccine. Upon internal review, anaphylactic shock was considered to be other important medical event. Additional information has been requested.									Y	11/21/2008	11/21/2008	0	diagnostic laboratory, 11/24/08, blood work - could not test him for any allergies regarding PNEUMOVAX 23	OTH	OTH	[therapy unspecified]; LESCOL XL	Asthma; Penicillin allergy			WAES0812USA00340	1						1	Anaphylactic shock; Blood pressure decreased; Blood test; Dyspnoea; Erythema; Pulse absent; Swelling face; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0334049	12/05/2008	CA	86.0			M	12/03/2008	Initial report received on the 25 Nov 2008. An 86-year-old male patient had received a dose of flu vaccine (trade name, manufacturer, lot number and route/site of administration not reported) two months ago. The next day, the patient's arm turned black at the injection site and was painful. Two months later, the patient still has the pain, which is now extending into the armpit. The patient saw an orthopedic doctor who took x-rays that were negative. The doctor administered a cortisone injection that only relieved the pain for two days. The black color went away after two weeks. Documents held by sender: None.				Y					N				X-rays (site not specified) were negative.	OTH	OTH	PLAVIX; ZOCOR; ALLOPURINOL; ASA		Medical history included arthritis, ileostomy, heart problems (not specified) and allergies to penicillin and sulfa.  Concomitant medications were FLAVIX, ZOCOR, ALLOPURINOL and Aspirin.  The patient had received previous flu vaccines every year since it was out.		200803739	1						1	Injection site discolouration; Injection site pain; X-ray normal	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0334051	12/05/2008	WI	81.0	81		M	12/03/2008	Initial report received on 29 November 2008 from a physician. An 81-year-old male patient, had received an intramuscular right deltoid injection of FLUZONE SV 2008-2009 on 28 October 2008, and the following day, developed a 4cm painful lump at the injection site. He subsequently developed generalized fatigue, pain in his legs, and aching in his body. At the time of this report, all symptoms were still persisting. The patient has extensive medical history that includes penicillin allergy, history of cerebrovascular accident (CVA), Type I Diabetes, hypertension (HTN), vitamin D deficiency, mitral valve disorder, anemia, atrial fibrillation (A-FIB), aortic valve disorder, thrombocytopenia, testicular hypofunction, edema, and hyperlipidemia. It was not reported whether the patient received any treatments for the symptoms, but it was reported that no relevant diagnostic tests or laboratory data were performed. At the time of this report, it was unknown if the patient had recovered. Documents held by sender: None.				Y					U	10/28/2008	10/29/2008	1	None	PVT	OTH	NIASPAN; ATENOLOL; COUMADIN; NITRO PASTE; LASIX; K-DUR; INSULIN; ASA		The patient had no concurrent illnesses at the time of the vaccination on 28 October 2008. The patient does have an allergy to penicillin and history of cerebrovascular accident (CVA), Type I Diabetes, hypertension (HTN), vitamin D deficiency, mitral valve disorder, anemia, atrial fibrillation (A-FIB), aortic valve disorder, thrombocytopenia, testicular hypofunction, edema, hyperlipidemia. The patient had not received any other vaccinations within four weeks of 28 October 2008, and had not experienced any adverse events with prior vaccinations in the past.		200803800	1						1	Fatigue; Injection site mass; Injection site pain; Pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2808A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334063	12/05/2008	KS	79.0	79		M	12/05/2008	Dizziness lasting 10 days, starting two days after shot administered.  Mild nausea				Y					Y	10/14/2008				PVT	PVT	None	None	None			1						1	Dizziness; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA156AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0334064	12/05/2008	WI	76.0	76		F	12/05/2008	One week following vaccination patient developed fatigue, myalgias, and arthralgias without any other signs or symptoms of acute illness. Seen in the office on this date, with persistent symptoms									U	11/07/2008	11/14/2008	7		UNK	UNK	Celexa, lorazepam, ASA	None	Osteoarthritis, labrynthitis, h/o pericarditis			1						1	Arthralgia; Fatigue; Myalgia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~3~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334067	12/05/2008	MD	67.0	67		M	12/05/2008	10 Post vaccination of Influenza vaccine patient diagnosed with Guillain-Bare Syndrome. 1/13/2009 MR received for DOS 11/7-12/5/2008 with D/C DX:  Guillain-Barre Syndrome. Pt presented 11/6/2008 with progressive extremity weakness, malaise, migrating neuropathies and difficult ambulation. Paresthesias noted in upper and lower extremities, reflexes decreased bilaterally, sensation intact. Tx with IVIG. Pt developed hyponatremia c/w SIADH.  Developed some SOB and atelectasis was noted-tx with incentive spirometry. Transferred to rehab 11/12/08 and by d/c was able to ambulate 1000 feet and assume most ADLs.					Y	30			Y	10/23/2008	11/06/2008	14	Labs and Diagnostics: CT brain scan WNL. MRI cervical spine WNL.  MRI brain (+) for mild chronic ischemic changes. MRI thoracici spine (+) for spondylosis. Na low. Chloride low. CPK 851.	UNK	UNK			PMH:  borderline HTN.  R shoulder capsulitis. Hemorrhoidectomy. Tendon transfer			1						1	Guillain-Barre syndrome	FLU3~CSL LIMITED~01349111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Hospitalisation	Influenza
0334070	12/05/2008	ND	5.0	5		F	12/05/2008	Child reported to parent on Saturday, 11/15/2008, two days after immunization, a sore left arm, with redness, swelling in uupper arm.  Seen by this nurse on 11/18/2006 with redness, induration, and tenderness of upper left arm size of palm (3x4 inches).  Child wss alert, active, out for dinner with parents.   Mother reports that in one week child was showing now symptoms.									Y	11/13/2008	11/15/2008	2	None	PUB	PVT	None	No	None			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling	DTAP~SANOFI PASTEUR~C2950AA~2~IM~LA~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500576P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~A0301-2~3~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0146X~3~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1774U~UNK~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0334072	12/05/2008	TX	42.0	42		F	12/05/2008	Sudden onset of fever, chills and bodyaches on 11/10/08 less than two weeks after flu vaccination followed by neurogenic bladder which required two emergency room visits on 11/11/08 and 11/12/08 resulting in intermittent self-catherization for one week; developed peripheral neuropathy in lower extremities on 11/13/08 requiring neurologist care; developed Bell's Palsy on 11/21/08 requiring neurologist care and hospitalization from 11/22-11/30/08 with steroid treatment for Guillain-Barre Syndrome. Follow-up visit with neurologist every two weeks and recovering from nerve damage at home until January 2, 2009.  2/10/09 D/C summary received for DOS 11/22-30/2008 with D/C DX:  Autoimmune Non-demyelinating Axonopathy (variant Guillain Barre Syndrome).  Pulmonary Embolism. Pt initially presented to PCP with c/o acute urinary retention and leg weakness which began ~11/11/08. Tx with self cath. Some improvement by 11/19/08, however developed complete R facial paralysis and admitted 11/22/08.  Pt tx with Solumedrol and IVIG with improvement in sx noted. Pt developed acute dyspnea c/w PE. Started on anti-coagulation meds. At d/c facial paresis resolved. Mild easy fatigability and paresthesias in the legs.  Normal DTRs.				Y	Y	9			N	10/29/2008	11/10/2008	12	CT scan of bladder (normal), CT scan of abdomen (normal), MRI of brain (normal), MRI of cervical, thoracic and lumbar spine (normal), CT scan of chest (normal), lumbar puncture (protein levels abnormally high) and several blood tests (results still pending). 2/6/09 Labs and Diagnostics:  Chest CT WNL.  Brain MRI WNL. UC 11/12/08(-).  UC 11/22/08 (+). CSF (+) RBCs, no olgoclonal bands, CSF glucose 87, CSF protein 32.1. Myelin Basic Protein (-). PFTs WNL. Venous flow studies (-) for DVT.	UNK	UNK						1						1	Blood test; CSF protein increased; Chills; Computerised tomogram normal; Facial palsy; Guillain-Barre syndrome; Lumbar puncture abnormal; Neurogenic bladder; Neuropathy peripheral; Nuclear magnetic resonance imaging brain normal; Nuclear magnetic resonance imaging normal; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA381BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation	Influenza
0334073	12/05/2008	MD	45.0	45		F	12/05/2008	Morning post vaccination developed severe pain and stiffness in left arm and shoulder.  Can barely move arm.  Pain radiates to chest wall, breast and neck. Any movement of shoulder joint causes severe pain.				Y					U	12/01/2008	12/02/2008	1	None	UNK	UNK	None	None	None			1						1	Breast pain; Injected limb mobility decreased; Musculoskeletal chest pain; Musculoskeletal pain; Musculoskeletal stiffness; Neck pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2772AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334074	12/05/2008	HI	16.0	16		M	12/05/2008	One day after immunizations, started with pain around RT ear and face getting progressively droopy. Recent URI as well.  No rash.   PERTINENT POSITIVES: droopy RT face.  Periauricular RT pain, mainly just above ear. Mild 2/10.  PERTINENT NEGATIVES: No  Fever, visual changes, excruciating HA.  No Emesis, weakness anywhere else.									U	11/28/2008	11/29/2008	1		PVT	PVT						1						1	Ear pain; Facial palsy	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88636~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|MNQ~SANOFI PASTEUR~U2812AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C3031AA~1~IM~RA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1510F~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0334099	12/05/2008		40.0	40		F	12/05/2008	This case was reported by a physician and described the occurrence of pruritus body rash in a 40-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included wheezing. On 23 October 2008, the subject received a dose of FLULAVAL (unknown). On 25 October 2008, two days after vaccination with FLULAVAL, the subject experienced pruritus body rash and vesicular lesions. On 03 November 2008, eleven days after vaccination with FLULAVAL, the subject experienced eosinophil infiltration of skin. At an unspecified time after vaccination with FLULAVAL, the subject experienced wheezing. The physician stated a subject received FLULAVAL on 23 October 2008 and presented with a pruritic severe rash all over her body that was diffuse, contained vesicular lesions on 25 October 2008. She saw a dermatologist on 03 November 2008 who performed a skin biopsy and showed eosinophilic infiltrates in the rash. The subject also experienced wheezing flare-ups that correspond to flare ups of the rash. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved.				Y					N	10/23/2008	10/25/2008	2	UNK	OTH	OTH		Unknown	Wheezing; No concomitant medications. It was unknown if the subject had previously received influenza vaccinations or experienced adverse events. It was unknown if the subject had adverse events following receipt of prior immunizations.		A0759325A	1						1	Condition aggravated; Eosinophilia; Rash generalised; Rash pruritic; Rash vesicular; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA180AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0334100	12/05/2008	AL	72.0	72		F	12/05/2008	This case was reported by a vaccine wholesale distributor and described the occurrence of flushing in a 72-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 21 October 2008, the subject received a dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced flushing, weakness, diaphoresis and dizziness. It was reported that the subject was placed in the supine position, given orange juice, a fruit bar and had cold compresses applied to the forehead. She was observed closely by the staff, released after 25 minutes (details of where the subject was released from was not provided). The subject was instructed to go to the emergency room if symptoms continued or worsened. At the time of reporting the outcome of the events were unspecified. Linked case numbers include A0754328A, A0754338A, A0754339A and A0755229A. GSK case number A0755269A is a duplicate of A0753609A. All future correspondence will be submitted to A0755269A. Concurrent medications included ZOCOR, SYNTHROID, LEXAPRO and CALTRATE PLUS minerals. On 20 October 2008 the subject received a dose of FLULAVAL at 0.5 ml in an unknown deltoid. On 20 October 2008, 5 minutes after vaccination with FLULAVAL, the subject experienced a pre-syncope episode requiring a doctor's visit. At the time of reporting the outcome of the pre-syncope episode was resolved. The healthcare professional considered the event was probably related to vaccination with FLULAVAL. A statement in the text of the report read: The cold packs were not frozen upon delivery. Tag alert indicated that the product was okay. Days later at room temperature, the Tag Alert still says okay. Monitored in the office for 30 minutes and then released. The reporter was concerned with this particular lot number (pharmaceutical product complaint). Follow-up information was received on 03 December 2008, via healthcare professional who reported the subject has a history of diabetes, hyperlipidemia, depressive disorder, and hypothyroidism. The events occurred on 21 October 2008 and resolved the same day. Additional events of decreased blood sugar and seizure were reported. The follow-up information did not state specific details regarding the seizure experienced by the subject. Information regarding seizure symptoms were provided and stated it was witnessed, the subject had weakness in lower extremities and she did not lose consciousness. She did remember the event and was monitored in the exam room. The subject was taking LEXAPRO antidepressant which is known to reduce the seizure threshold. The reporting healthcare professional considered the events life threatening and related to vaccination with FLULAVAL.			Y	Y					Y	10/20/2008	10/21/2008	1	Unknown	PVT	PVT	Simvastatin; Thyroxine sodium; LEXAPRO; CALTRATE PLUS	Unknown	Depressive Disorder; Hyperlipidemia; Hypothyroidism; The subject has no relevant medical history. Linked case numbers include A0754328A, A0754338A, A0754339A and A0755229A.		A0755269A	1						1	Asthenia; Blood glucose decreased; Convulsion; Dizziness; Flushing; Hyperhidrosis; Pharmaceutical product complaint; Presyncope	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA208AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening	Influenza
0334102	12/05/2008	NE	55.0	55		M	12/04/2008	Patient felt a little tighter in breathing. Worried it might be anaphylaxis. But also has anxiety problems that make breathing more difficult.									Y	11/30/2008	12/02/2008	2	Just an anxiety reaction, everything passed.	OTH	PVT		None	allergic to rag weed			1						1	Anxiety; Dyspnoea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89968~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334103	12/05/2008	UT	23.0	23		F	12/07/2008	Swelling at injection site, fever, nausea.									Y	10/17/2008	10/18/2008	1		OTH	PUB	BNZ					1						1	Injection site swelling; Nausea; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~29221~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334104	12/05/2008	CA	81.0	81		F	12/05/2008	Throbbing, aching, (inflamed) pain 3.									Y	11/20/2008	11/22/2008	2		OTH	PUB	Atenolol; Vytorin; Diovan HCT		NKDA			1						1	Inflammation; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89994~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334105	12/05/2008	WA				F	11/06/2008	Fine papular rash covering entire trunk and arms, itchy.									Y	10/22/2008	10/23/2008	1	None	PUB	UNK	none	none	none			1						1	Rash papular; Rash pruritic	FLU3~SANOFI PASTEUR~U2808AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334106	12/05/2008	CA	29.0	29		F	12/05/2008	3:00 pm blurred vision began. 3:30 pm swollen throat began. 4:00 pm congestion began. 5:00 pm noticed eyes were red and yellow discharge in the inner corners. Declining health through the evening. Slept 14 hours, felt better.									Y	11/12/2008	11/12/2008	0		OTH	PVT	ORTHOTRICYCLEN lo	None	None			1						1	Eye discharge; Nasal congestion; Ocular hyperaemia; Pharyngeal oedema; Vision blurred	FLUX~UNKNOWN MANUFACTURER~V2748AA~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0334107	12/05/2008	TX	59.0	60		F	12/04/2008	See attached sheet.				Y					Y	10/20/2008	10/20/2008	0		PUB	OTH						1						1	Arthralgia; Fatigue; Glaucoma; Nausea; Ocular hyperaemia; Pain in extremity; Photosensitivity reaction; Rheumatoid factor negative; Somnolence; Uveitis	FLUX~UNKNOWN MANUFACTURER~~3~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0334110	12/05/2008	NH				F	12/05/2008	Developed swelling and pain 2 days post vaccine in (L) knee. Evaluated by PCP x-rays and blood work NEG Dx Reactionary Arthritis Took Tylenol for pain.									U	11/10/2008	11/12/2008	2		OTH	PVT		None	None			1						1	Arthralgia; Arthritis; Blood test normal; Joint swelling; Pain; X-ray normal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89748~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334111	12/05/2008	TN	24.0	24		U	10/30/2008	Developed hives to bilateral antecubes 1.5 hours after receipt first Flumist vaccine. Itching and increased hive formation noted after shower 16-24 hr post vac. Seen by Clinic MD and dx with urticaria. No other symptoms. Symptoms: Pruritus, lesions, papule.				Y					U	10/29/2008	10/29/2008	0		MIL	MIL	None	None	None			1						1	Pruritus; Rash papular; Skin lesion; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~S00552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0334112	12/05/2008	MO	15.0	15		F	12/04/2008	Patient sat down next to father after vaccines were given in the triage area. Several staff saw patient put head down and shook her head for a few seconds. Vital signs were then obtained of 10 minutes for 30 minutes. Vital signs were stable. Patient was given cold water to drink and crackers.									Y	12/04/2008	12/04/2008	0		OTH	PUB		None				1						1	Tremor	FLU3~SANOFI PASTEUR~U2840AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1740U~UNK~UN~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2666AA~UNK~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0334115	12/05/2008	CA	17.0	17		F	12/05/2008	Patient was seen on 11.17.08 and noted: lesion on upper extremity: arm, on the right for 2 days, which has been painful and red. It has been swollen, and has not been draining pus/fluid. Started Sat am after receiving PNEUMOVAX on Friday, low grade fever up to 100 degrees, vomited once, and has a headache. Patient was seen on 11.18.08 and Dr noted: this is a 17 year old female patient who comes in to the clinic in follow up after yesterday's visit. Yesterday we treated her for a cellulitis at the site of injection that had occurred on 11/14/08. The area was red, warm and swollen. I had started her on CLINDAMYCIN orally and that area had actually improved. It is much lighter red, the swelling is better and the warmth is better but overnight she has developed a new area about 2 inches below the site of injection that looks very similar and has been growing bigger. It is very red, warm and swollen as well. They had been putting compresses on the area. She has had three doses of CLINDAMYCIN. Patient was seen on 11.20.08 and Dr noted: 17 year old female here for a follow up reaction to PNEUMOVAX received 11.14.08 However, the injection site for the flu shot has remained uneventful. She was seen at ER for IV antibiotic therapy and is finally responding. She is taking CLEOCIN and DOXYCYCLINE. Patient was seen on 11.21.08 and Dr noted: resolving cellulitis. There is little to no heat or induration of distal aspect of upper arm but small amount of induration remains at injection site.				Y					Y	11/14/2008	11/15/2008	1	CBC w/auto diff; Sed rate; Blood culture; comprehensive metabolic	PVT	UNK			Allergies; Penicillin, AUGMENTIN, sulfa and ERYTHROMYCIN			1						1	Blood culture; Erythema; Full blood count; Headache; Injection site cellulitis; Injection site erythema; Injection site swelling; Injection site warmth; Metabolic function test; Pain; Pyrexia; Red blood cell sedimentation rate; Skin lesion; Swelling; Vomiting	FLU3~SANOFI PASTEUR~U2768AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1076x~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0334117	12/05/2008	FL	79.0	79		F	12/04/2008	Redness and swelling around injection site down to patient's Rt elbow.				Y						11/08/2008	11/08/2008	0		PVT	PVT		None	Codiene			1						1	Injection site erythema; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~A7LAA154AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0619X19733401~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0334077	12/06/2008	FL	40.0	40		F	12/06/2008	Shoulder pain became severe approximately 2 hours after influenza vaccination, with inability to raise arm; active range of motion severely compromised, passive range of motion moderately compromised. Mild chronic pain; moderate to severe night pain. Consistent with adhesive capsulitis. Tx: Naproxen 500 mg bid, steroid injection at shoulder, daily physical therapy.				Y					N	10/30/2008	10/30/2008	0	x-rays, reflex tests, range of motion tests	UNK	UNK	None	None	None			1						1	Diagnostic procedure; Joint range of motion decreased; Mobility decreased; Musculoskeletal pain; Pain; Periarthritis; X-ray	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA157AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0334078	12/06/2008	MO	17.0	17		F	12/02/2008	nausea & increased racing heartbeat									Y	12/02/2008	12/02/2008	0		PVT	UNK						1						1	Nausea; Palpitations	FLUX~UNKNOWN MANUFACTURER~?????????????~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~?????????????~UNK~UN~LA~HEP A (NO BRAND NAME)~1	USA		Influenza
0334079	12/06/2008	IA	9.0	9		M	12/06/2008	My son received the Flumist vaccine on November 7th at 4:30pm.  On November 8th at approximately 2:30 am, he had a grand mal seizure.  He was not ill at the time and was afebrile.  We went to the ER, and his labs and CAT scan were normal.  The next week he had an MRI and EEG, both of which were also normal.  He has not had another seizure since.  He has no past history of seizures.				Y					Y	11/07/2008	11/08/2008	1	CBC, chemistry panel, CAT scan, EEG and MRI were all normal	UNK	UNK	None	None	NKDA     No pre-existing conditions			1						1	Computerised tomogram normal; Electroencephalogram normal; Full blood count normal; Grand mal convulsion; Laboratory test normal; Nuclear magnetic resonance imaging normal	FLUX~UNKNOWN MANUFACTURER~unknown~1~IN~NS~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0334081	12/07/2008	NC	59.0	59		F	12/07/2008	Symptoms resembling influenza: chills, fever, aches and pains in arms and body.  Arm unusually sore at the vaccination site on the day of injection and couple of days after injection on 10/21/08.  Flu-like symptoms again on 12/1/2008 that are still in progress with severe chills, fever, aches, pains, coughing, sneezing, running nose, etc.									Y	10/21/2008	10/21/2008	0	Did not visit doctor.	PUB	PVT		No. I have been taking a flu shot every year for years and have not had a reaction to it.				1						1	Chills; Cough; Influenza like illness; Injection site pain; Pain; Pyrexia; Rhinorrhoea; Sneezing	FLUX~UNKNOWN MANUFACTURER~2008-09~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0334082	12/07/2008	CA	4.0	4		F	12/07/2008	The flu shot was administered at approximately 9:50 am on 10/1/08, this was 10 minutes AFTER providing the doctor with a urine sample (9:40 am) for patient's annual preventative examination.  No blood was present in this urine sample.  At approximately 1:30 pm on 10/1/2008, there was blood visible in patient's urine.  I called Dr's office to have them make sure they test for a bladder infection because I saw blood in her urine.  At 5:15 pm on 10/1/2008 after her nap, there was still blood in patient's urine and at this time she was complaining of pain in her abdominal area and lower back area.  We then went to hospital at 5:30 pm on 10/1/2008 where the hospital took her temperature (low grade fever around 99), did a urine sample, and an ultrasound.  Patient vomited around 10:00 pm while at the emergency room and on the way out of the emergency room.  The emergency room physician did not know what was wrong so he released patient when he felt comfortable that her blood pressure had come down.  He instructed us to take her to Dr. the next morning.  The last time I visibly saw blood in patient's urine was at approximately 8:00 pm on 10/1/2008.  The morning of 10/2/2008 I took patient back to Dr. where they did another urine sample.  Since the night before, I had not seen any more blood in her urine; however, the urine sample still showed signs of blood.  Dr. was not able to identify why there was blood in patient's urine.  Dr. scheduled us to go to another hospital to see Dr. in the Pediatric Nephrology department.  Our appointment was on 10/3/2008.  Patient gave a urine sample which, when tested, still had blood present (although the blood was NOT visible to the eye.)  Dr. examined patient and asked us questions, trying to rule out kidney diseases and a bladder infection (FYI, patient NEVER experienced pain while urinating).  Dr. did not know what the cause was so he ordered blood work that was done at that visit on 10/3/2008.  Dr's office called me and said they wanted another blood panel done because when they took the blood panel on 10/3, patient was a bit dehydrated.  On 10/14/2008, we went to the Lab and had the blood draw done.  When we saw Dr. at patient's 10/29/2008 follow up visit, she had an ultra sound and gave a urine sample.  In the visit Dr. said her urine was normal (no blood), the left kidney was a little larger than the right but that may be normal for her, and her blood work from 10/14 was normal.  Dr. did ask for more blood work and for patient to come back for a follow up visit in February (she goes back on 2/25/2009).  I called to find out the blood work results on 10/29 and the nurse told me everything was normal and Dr. would have called me if something was wrong.  My husband and I feel she had a reaction to the flu shot; however, no one will confirm or even consider this.  Patient was well at the time of the flu shot on 10/1/2008 and there was no blood in her urine at 9:50 am.  Then just a few hours later at 1:30 pm there was blood visible in her urine which was no longer visible after 8:00 pm that night; she also vomited at the emergency room around 10:00 pm; and she had a low grade fever at the emergency room.  Patient did come down with a flu bug on 9/12/2008 at 8:00 pm and vomited off and on from 9/12 through 9/15.  However, she had fully recovered and was well the day of the flu shot, 10/1/2008.				Y					Y	10/01/2008	10/01/2008	0	10/1/2008 urine sample at Dr's office.   10/1/2008 Flu shot at Dr's office.   10/1/2008, temperature taken, urine sample taken, and an ultrasound at hospital.  10/2/2008, urine sample at Dr's office.   10/3/2008 urine sample and blood work at hospital in the Pediatric Nephrology department.  10/14/2008 blood work at lab.   10/29/2008 ultra sound, urine sample, and blood work at hospital/Dr's office.	UNK	UNK	Ethedent 0.5 mg Tab Chewable is patient's only prescription medication taken on a regular basis.	None	None.	None~ ()~~0.00~In Patient		1						1	Abdominal pain; Back pain; Blood pressure increased; Blood test; Blood urine present; Dehydration; Pyrexia; Ultrasound scan; Urine analysis; Vomiting	FLU3~SANOFI PASTEUR~U2786BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334084	12/08/2008	HI	23.0	23		F	12/08/2008	Pt developed maculopapular rash associated with generalized itchiness without respiratory involvement after receiving anthrax and flumist 18 Nov 08. On 20 Nov 08, pt was also seen in ship's medical with complaint of fever and diff of swallowing, dx with acute tonsilitis and was given azithromycin and tylenol for fever. Pt developed the rash 8 hours after medication were given and 2 days after shot/mist were given.									Y	11/18/2008	11/20/2008	2		UNK	MIL	Azithromycin, Tylenol					1						1	Acute tonsillitis; Dysphagia; Pruritus generalised; Pyrexia; Rash; Rash maculo-papular	ANTH~EMERGENT BIOSOLUTIONS~FAV174~1~SC~RA~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500563P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0334157	12/08/2008	IL	59.0			M	11/10/2008	Redness & swelling at site of injection with a pimple-like raised area at the actual injection site.									Y	11/04/2008	11/07/2008	3		PVT	PVT		None	None			1						1	Injection site erythema; Injection site mass; Injection site swelling	FLU3~SANOFI PASTEUR~U2740AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334158	12/08/2008	MO	58.0	58		F	11/07/2008	Redness, swelling at site, date given 11-04-08. Calls 11-7-8 with report pain at site, warmth, swelling and red approx size of fist X 2 days. Pt. advised her to use ice with heat and TYLENOL PRN, per RN Pt to call in 4 hr before office closes with report.									U	11/04/2008	11/05/2008	1		PVT	UNK						1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2740AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0233X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0334159	12/08/2008	AR	59.0	59		F	11/25/2008	PT had influenza injection in deltoid.  C/o deep muscle pain to wrist X 2-3 weeks.   Took OTC ALLEVE sporadically.  Concerned re: nerve damage or staph infection pending.										11/06/2008	11/08/2008	2	None	OTH	PUB		None	Unk	None reported~ ()~~0.00~In Patient	ARO844	1						1	Myalgia	FLU3~SANOFI PASTEUR~U2840AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334160	12/08/2008	NM	49.0	49		F	12/04/2008	12/1/08 5pm patient states cough, some swelling under tongue and chills. 12/2/08 Patient called office complaining of mouth dry, lips puffy, throat scratchy. No swallowing or breathing difficulty. Injection site without redness or swelling, afebrile.									Y	12/01/2008	12/01/2008	0	12/2/08 seen for follow up by Dr placed on XYZAL, 5mg, qd	PVT	PVT	EFFEXOR; IMITREX; LUNESTA; Iron		Allergy; IVP dye; diagnosed Anemia; IBS (irritable bowel syndrome); TMJ; headaches; depression, anxiety; ovarian cyst			1						1	Cough; Dry mouth; Lip swelling; Throat irritation	FLU3~SANOFI PASTEUR~U2853AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334161	12/08/2008	WI	37.0	37		M	11/24/2008	Lip swelling within 15 minutes of injection. Immediately went to ED. Treated with BENADRYL, Cortisone injection. Was able to leave ED 3 hours later. Full recovery.				Y					Y	11/20/2008	11/20/2008	0	Unknown	OTH	PVT	Unknown	None	Fish allergy			1						1	Food allergy; Immediate post-injection reaction; Lip swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89748~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0334162	12/08/2008	CA	9.0	9		F	12/09/2008	Raised area of induration and redness, urticaria at site of vaccine administration noted next morning with pain.									U	12/03/2008	12/04/2008	1		OTH	OTH		None	None			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site urticaria	FLU3~SANOFI PASTEUR~U2829AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0651X~1~IM~LA~HPV (GARDASIL)~1|VARCEL~MERCK & CO. INC.~1321X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0334166	12/08/2008	MN	30.0	30		F	11/13/2008	Red swollen eyes 4 hrs after shot. Also have a slight fever and sore throat. Eyes have a yellow discharge and are itchy.									U	11/12/2008	11/12/2008	0	None	PUB	PUB	Unknown	None	None			1						1	Eye discharge; Eye pruritus; Eye swelling; Ocular hyperaemia; Oropharyngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U28448AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334167	12/08/2008	PA	3.0	3		M	12/03/2008	Area edema, red, warm.									Y	12/01/2008	12/03/2008	2		PVT	PUB		None				1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLUN3~MEDIMMUNE VACCINES, INC.~C87310~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|PNC~PFIZER\WYETH~500560P~4~IM~UN~PNEUMO (PREVNAR)~1	USA		Influenza
0334170	12/08/2008	IN	1.0	1	.0	M	12/08/2008	Pt. accidentally given a MENACTRA instead of an MMR on 12/5/08, error discovered on 12/8/08. Called mom. Pt. doing well. No treatment needed.									Y	12/05/2008	12/08/2008	3	None	PUB	PUB	None	None	None			1						1	Wrong drug administered	FLU3~SANOFI PASTEUR~UT2792DA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB289CB~1~UN~LL~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2729AA~1~UN~RL~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~1281x~1~UN~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0334194	12/08/2008	FL	57.0	57		F	11/14/2008	RECD VACCINES MID AFTERNOON 11-12-08. STATES THAT IN THE NIGHT SHE BEGAN HAVING FEVER,CHILLS & PAIN @ INJECTION SITES. ALSO STATES SHE ACHED ALL OVER.ALSO INDICATED SHE HAD LABORED BREATHING. TOOK ASPIRIN FOR FEVER & PAIN.wAS SEEN BY ONE OF THE ACHD PRACTITIONERS.				Y					U	11/12/2008	11/12/2008	0	N/A	PUB	PUB	N/A	N/A				1						1	Chills; Dyspnoea; Injection site pain; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2805AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~08681~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0334195	12/08/2008	NC	56.0	56		F	12/08/2008	Hard swelling and soreness at injection site (left deltoid), persisting for 6 weeks.  Pain increases in upper left arm and shoulder after physical activity.									U	10/27/2008	10/28/2008	1		UNK	UNK	Levothyroxine					1						1	Injection site induration; Injection site pain; Pain; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA172AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0334196	12/08/2008	VA	62.0	62		M	12/08/2008	1.Minor pain around area shot was administered.2. Two days of racing heart.3. Two weeks of fever and cough. I have not had a reaction like this any time before.										11/24/2008	11/25/2008	1		PUB	MIL	None	None	None			1						1	Cough; Injection site pain; Palpitations; Pyrexia	FLU3~CSL LIMITED~1449111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0334197	12/08/2008	AZ	4.0	4		M	12/08/2008	LOCAL RED, WARM AND INFLAMMED REACTION ON LEFT ARM, SHOULDER AREA.  ITCHY RASH ALSO ON SHOULDER AREA.									U	12/04/2008	12/06/2008	2		PUB	PUB						1						1	Erythema; Inflammation; Local reaction; Rash pruritic; Skin warm	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B103AC~1~IM~LA~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~U2806AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1079X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1188X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0334202	12/08/2008	NC	8.0	8		M	12/08/2008	SPLOTCHES, COUGH DIFFICULTY BREATHING  PATIENT WAS TREATED WITH 0.3cc OF EPINEPHRINE (LDIM), PER DR'S ORDER.				Y					Y	12/04/2008	12/04/2008	0		UNK	UNK	DIAMOX, CLARITIN, RHINOCORT	NONE	ALMONDS, AUGMENTIN			1						1	Cough; Dyspnoea; Rash macular	FLU3~SANOFI PASTEUR~U2839AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334205	12/08/2008	MS	55.0	55		F	12/08/2008	itching, anxious feeling, redness on hands and arms									Y	12/02/2008	12/02/2008	0		UNK	UNK	detrol LA, prilosec		alleries to fragrances and unknown chemicals, codeine,morphine, demerol			1						1	Anxiety; Erythema; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA192AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0334207	12/08/2008	MN	65.0	65		F	12/08/2008	Patient developed hives approximately 3 days after the immunization was given.									Y	10/07/2008	10/10/2008	3		PUB	PUB		None	Hypertension,  Fibromyalgia			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2802AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334208	12/08/2008	WI	2.0	2	.4	F	12/08/2008	Father of patient states, about one hour after receiving the Flumist, patient's eyes became puffy and swollen. This lasted for three to four hours, then eyes returned to normal state.									Y	11/19/2008	11/19/2008	0		UNK	UNK						1						1	Eye swelling	FLUN3~MEDIMMUNE VACCINES, INC.~500547P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0334209	12/08/2008	WA	74.0	74		M	12/08/2008	2-3 hours after receiving vaccination he experienced a syncopal episode and became diaphoretic and weak.  Drove self to local ED and was admitted to ICU for cardiac work-up.  Unsure results of evaluation. 12/10/08 MR received for DOS 11/6-7/2008 with D/C DX:  Presyncope-unclear etiology.  Pt presented after an episode of light-headedness. W/U (-).				Y	Y				Y	11/05/2008	11/05/2008	0	Labs and Diagnostics:: EKG (+) for bradycardia and 1' AV block.  CXR WNL. Cardiac enzymes WNL.  CPK and myoglobin increased. CKMB WNL.  Creatinine 1.9. Glucose 190./	PUB	OTH	Albuterol; amlodipine; HCTZ; insulin; ipratropium; mometasone; niacin; simvastatin; levothyroxine; travaprost	None	CAD, glaucoma, hypertension, COPD, renal insufficiency, hyperlipidemia, PVD, diabetes.			1						1	Asthenia; Hyperhidrosis; Intensive care; Syncope	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA174AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation	Influenza
0334210	12/08/2008	NH	66.0	66		F	12/08/2008	24 hours after injection soreness at site and red erythema Left deltoid 6 inches in diameter									Y	12/03/2008	12/04/2008	1		PVT	PVT		NONE	EMYCIN AND SULFA			1						1	Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U2764AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1407X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0334211	12/08/2008	CA	59.0	59		M	12/08/2008	- Patient got the chills and was unable to get warm. Tried to put on jacket and turn on heater (12/3/08). Was relieved later without any treatment.									Y	12/03/2008	12/03/2008	0		UNK	UNK						1						1	Chills; Feeling cold	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88129-4P~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334212	12/08/2008	CA	52.0	52		F	12/01/2008	Patient received Influenza Vaccine Nov 17, 2008 and reported symptoms to office 11/21. Described redness and swelling on arm/injection site 24-72 hours post administration. By 11/21 symptoms resolved.									Y	11/17/2008	11/17/2008	0		UNK	UNK	None Known	None known	None known			1						1	Injection site erythema; Injection site swelling	FLU3~CSL LIMITED~04549111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0334213	12/08/2008	MS	67.0	67		F	12/08/2008	PT HAS AN EGG ALLERGY AND I ACCIDENTLY GAVE HIM A FLU VACCINE									Y	11/25/2008	11/25/2008	0		UNK	PVT						1						1	Food allergy; Wrong drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89985~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334215	12/08/2008	SC	35.0	35		F	11/24/2008	A serious spontaneous report of myoclonic spasms of lower and upper extremities was received from a physician concerning herself, a then 35-year-old female subsequent to FLUMIST. The patient's past medical history includes attention-deficit hyperactivity disorder, auto-immune disorder not otherwise specified and a hyperactive immune system. Concomitant medications were not reported. The patient received FLUMIST intranasally in Oct-2006 for prevention of influenza. Approximately one week after receiving FLUMIST the patient experienced brief tic-like myoclonic jerks of lower extremities and upper extremities when relaxed. The patient saw a neurologist and was determined to have borderline multiple sclerosis. The symptoms improved gradually and resolved completely after approximately five months. Required followup attempts have been performed, requested information unable to be obtained.									Y	10/01/2006	10/01/2006	0		PVT	PVT	Concomitant Drug(s) Not Reported	ADHD; Autoimmune disorder NOS	Hyperactive immune system		MEDI0007588	1						1	Multiple sclerosis; Myoclonus	FLUN3~MEDIMMUNE VACCINES, INC.~~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0334216	12/08/2008	SC	37.0	37		F	11/24/2008	A serious spontaneous report of myoclonic spasms of lower and upper extremities was received from a physician concerning herself, a 37-year-old female subsequent to FLUMIST.  The patient's past medical history includes attention-deficit hyperactivity disorder (ADHD), an auto-immune disorder not otherwise specified with hyperactive immune system, and she developed myoclonic jerks one week after receiving FLUMIST in 2006 (MEDI-0007588).  Concomitant medications include LISDEXAMFETAMINE since 25-SEP-2008 for ADHD.  The patient received FLUMIST intranasally on 23-Oct-2008 for prevention of flu.  Approximately five days after receiving FLUMIST, the patient experienced brief tic-like myoclonic jerks of the lower and upper extremities when relaxed.  The symptoms from this occurrence are less than the first occurrence in 2006.  She received an IM influenza injection in 2007 with no problems.  The patient stated that she is getting better as evidenced by initially twitching three to four twitches per day, but now she is twitching three to four times per week.  The patient stated that she does not plan to see a specialist. Required follow-up attempts have been performed, requested information unable to be obtained.										10/23/2008	10/28/2008	5		PVT	PVT	VYVANSE	ADHD; autoimmune disorder NOS	Hyperactive immune system; Myoclonic jerks		MEDI0007545	1						1	Muscle twitching; Myoclonus; Vaccine positive rechallenge	FLUN3~MEDIMMUNE VACCINES, INC.~~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0334217	12/08/2008	GA	2.0	2	.1	M	12/08/2008	Patient's mother states that the child started a fever on 12-6-08 that continues today 12-8-08 Temp 102 degrees denies redness/swelling at injection site. Denies headache, nausea and vomiting or any other symptoms. States he looks like he feels fine. He just has a fever Referred to MD.				Y						12/05/2008	12/06/2008	1		PUB	PUB	None	None	None			1						1	Pyrexia	FLU3~SANOFI PASTEUR~UT2788HA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334218	12/08/2008	NH	42.0	42		F	12/05/2008	Arms started to ache, then body aches, HA's to nausea, recovered within 24 hrs.									Y	12/02/2008	12/02/2008	0	None	PVT	PVT	Prilosec	None	NKDA- Ulcerative colitis; allergic vaimitis; gerd; herpes			1						1	Headache; Nausea; Pain	FLU3~SANOFI PASTEUR~U2790AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334220	12/08/2008	TX	12.0	12		F	12/08/2008	Pt felt dizzy and got pale, never fainted, MD stated Pt always eating at school but had not eaten today. B/P 90/50, left clinic after 15 min and okay.									Y	12/08/2008	12/08/2008	0		PUB	PUB	None	None	None			1						1	Dizziness; Pallor	FLU3~SANOFI PASTEUR~U2791CA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0650X~1~UN~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2658AA~1~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B023AA~1~UN~RA~TDAP (BOOSTRIX)~1	USA		Influenza
0334221	12/08/2008	WI	61.0	61		M	12/05/2008	face flashed. Accelerated heart rate. At 8pm went to bed, at 10pm walked up with chills, fever and body aches. At midnight head ache continue, body aches, chill till 4am. By 5am all symptoms were gone but head ache remained. At 6am took EXCEDRIN by 7am head ache subsided. During the night had a full bladder; had to empty three times. Urine had an unusual medicine smell. all symptoms were away by 8am next morning									U	11/25/2008	11/25/2008	0	None	OTH	UNK	None	None	Flare-up colitis presiding month to vax			1						1	Chills; Flushing; Headache; Heart rate increased; Pain; Pollakiuria; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0334222	12/08/2008	MI	65.0	65		M	12/08/2008	4 days after receiving FLUVIRIN and PNEUMOVAX vaccines he developed fever to 101, myalgias, headache, fatigue.									Y	10/17/2008	10/21/2008	4	None	PVT	PVT	Toprol; Pravadrol; Levothyroxine; Viagra	None	Caning disease; hypothoidia; osteorthritis; colon odemds			1						1	Fatigue; Headache; Myalgia; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8811002~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0380U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0334223	12/08/2008	MA	8.0	8		F	12/08/2008	patient started to complain of excruciating headache pain in 1 1/2 hours after receiving the FLUMIST. Mom gave her TYLENOL and said patient was feeling better since treatment. Mom will call back if headache returns or worsens.									Y	12/05/2008	12/05/2008	0		PVT	UNK			NKA			1						1	Headache	FLUN3~MEDIMMUNE VACCINES, INC.~500570p~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0334224	12/08/2008	WI	5.0	5		M	12/08/2008	Thursday am in school patient reported itching, progressed to a blotchy, wet-like rash on lower extremities on thurs afternoon and evening. On Fri 2 waits noted on abd. That is when grandmother called Health dept.									Y	12/01/2008	12/04/2008	3		PUB	PUB						1						1	Pruritus; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500561P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0334226	12/08/2008	MO	67.0	67		M	12/08/2008	Bruise at injection site.									Y	11/12/2008	11/15/2008	3		OTH	PVT		None				1						1	Injection site haematoma	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA193BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0334227	12/08/2008	TX	70.0	70		F	12/08/2008	Pt called approximately 4-5 hours after receiving vaccine with difficulty swallowing. No shortness of breath. Sent to ER				Y					U	12/08/2008	12/08/2008	0		PVT	PVT	PREMPRO, AMOXIL	None	PCN-Swelling			1						1	Dysphagia	FLU3~SANOFI PASTEUR~U2833AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334228	12/08/2008	AZ	5.0	5		M	12/08/2008	Onset of fever, vomiting and swelling/rashes, pain (L) arm following vaccination of PNEUMOVAX. Patient vomited, lasted 24 hrs. Tx with MOTRIN. Arm swelling, pain (L) arm, lasted 4 hrs. Tx with warm soaks.									Y	12/04/2008	12/04/2008	0		PUB	PUB	None	None	Was premature baby 38 wks.  Has Asthma plus RSV. Previous pneumonia multiple times			1						1	Oedema peripheral; Pain in extremity; Pyrexia; Rash; Vomiting	FLU3~SANOFI PASTEUR~U25829AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0380U~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0334229	12/08/2008	AZ	7.0	7		F	12/08/2008	Fever 103, vomiting, pain and swelling at injection site 11 hrs post vaccination.  Fever and vomiting for 26 hours.  Treated with Motrin/Tylenol, fluids, warm wash cloth to site.									Y	12/04/2008	12/05/2008	1	None	PUB	PUB	None	None	Asthma			1						1	Injection site pain; Injection site swelling; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2829AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0380U~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0334230	12/08/2008	MN	32.0	32		F	11/30/2008	I'm writing you as on Nov 13, 2008 I received a flu shot. This is the consecutive flu shot I've received for 3 years. However this time about 45 minutes later I could not move my arm for two hours. (Even though I had put ice on my arm). My husband had to help me get undressed even. I was in so much pain for the two hours where I could not move my arm I was shaking. The pain went all the way down my arm and into my fingers. I struggled to bend my elbow for a few days. When rubbing my elbow noticed a lump on the inside. For two days I had trouble grasping anything between my index finger and my thumb. I still cannot keep my arm above my head when sleeping as I wake up screaming or saying ouch as my arm at my shoulder hurts. On Thursday Nov 20 I went to the Dr as my elbow by where the lump is started to get itchy. I was even getting a rash as I had little red dots. The Dr that I seen said because of the flu shot that my lymph gland in my elbow became inflamed. The Dr checked my other lymph glands to be sure they were okay. He also checked the injection site by pushing on the injection site. (There was some pain when the Dr pushed on the injection site). I was told that if the pain increases, the rash becomes worse, or the lump becomes bigger that I need to be seen again. The rash has gone away from cream. On 11/27/08 I went into the ER as my arm was in so much pain. After getting an ultrasound and found out I did not have a clot. I was diagnosed with Complex Regional Pain Syndrome (CRPS) also known as Reflex Sympathetic Dystrophy (RSD) from getting the flu shot as the pain started so intense and shortly after.				Y					U	11/13/2008	11/13/2008	0		UNK	UNK						1						1	Complex regional pain syndrome; Grip strength decreased; Inflammation; Injected limb mobility decreased; Injection site pain; Mass; Pain; Pain in extremity; Pruritus; Screaming; Tremor; Ultrasound scan abnormal	FLU3~SANOFI PASTEUR~U2772AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334322	12/08/2008	AL	44.0	44		F	10/17/2008	Numbness in arm. Inability to perform daily tasks (i.e...hold dental mirror,etc). Pain in wrist and elbow.				Y					U	10/14/2008	10/14/2008	0	Unknown	OTH	OTH	Unknown	Unknown				1						1	Activities of daily living impaired; Arthralgia; Hypoaesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0329358	12/09/2008	FL	67.0	67		F	11/22/2008	At 5:30 p.m., I noticed a rash over my body. At 7:10 A.M., the following day, my BP was very low, resulting in passing out on kitchen floor. The rash lasted 3 days.									Y	10/10/2008	10/10/2008	0		OTH	OTH		None				1						2	Fall; Loss of consciousness; Urticaria; Hypotension; Loss of consciousness; Rash generalised	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~1~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0329989	12/09/2008	SD	66.0	66		F	11/11/2008	The patient reports passing out approximately 2 hours after receiving her shot.  She was at home and once this happened, she doesn't remember anything after that until waking up in hospital where she was kept overnight.					Y	1			Y	10/21/2008	10/21/2008	0		OTH	PVT						1						2	Concussion; Fall; Amnesia; Loss of consciousness	FLU3~SANOFI PASTEUR~U2766AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2766AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0330784	12/09/2008	CO	61.0	61		F		102 fever for 3 days, 3 diameter circular raised, hard, red, painful, swelling in left arm above elbow.  Couldn't use or raise arm for 4 days.  Fatigue, aches and pain, headache for four days.  Treated with Advil and heating pad on arm.									Y	10/22/2008	10/23/2008	1		OTH	UNK		None	None			1						2	Activities of daily living impaired; Induration; Injected limb mobility decreased; Oedema peripheral; Pain in extremity; Erythema; Fatigue; Headache; Hypokinesia; Induration; Oedema peripheral; Pain; Pain in extremity; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89971~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0061U~1~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~66521011110~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~00006473900~UNK~UN~UN~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0331814	12/09/2008	MN	64.0	64		F	11/24/2008	Dyspnea, Tachycardia, Diarrhea, Fatigue, Facial flushing. All resolving over past several months.					Y	3			Y	11/20/2007	11/22/2007	2	Testing essentially normal	PVT	UNK						1						2	Anorexia; Colonoscopy; Computerised tomogram; Diarrhoea; Dyspnoea; Echocardiogram; Endoscopy; Erythema; Flushing; Heart rate increased; Palpitations; Palpitations; Rash macular; Respiratory tract congestion; Vision blurred; Weight decreased; Diarrhoea; Dyspnoea; Fatigue; Flushing; Laboratory test normal; Tachycardia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA323BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA323BA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Hospitalisation	Influenza
0332117	12/09/2008	MN	39.0	39		F	11/12/2008	Sore throat, high fever, rapid heart beat, headache eyes swollen and red.									Y	11/11/2008	11/11/2008	0		OTH	PVT	TOPROL XL, ASPIRIN, ZYRTEC	allergies	allergic to pnc, congenital heart defect, high blood pressure			1						2	Eye swelling; Headache; Heart rate increased; Ocular hyperaemia; Oropharyngeal pain; Pyrexia; Eye swelling; Headache; Heart rate increased; Ocular hyperaemia; Oropharyngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U2754AA~4~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0332317	12/09/2008	NC	55.0	55		F	12/09/2008	Patient complained that throat felt like it was closing and tightening and she was having difficulty swallowing.She started coughing forcefully and wheezing.She noticed an increased amount of sinus drainage. She contacted the nurse and nurse transported pt to doctor for evaluation. She received epinephrine 0.3 mg sq as well as  use of her albuterol inhaler x 2 puffs,benadryl 50mg IM, and Solu Medrol 40mg IM.			Y	Y					Y	11/06/2008	11/06/2008	0		UNK	PVT		Sinus Drainage	allergic to dairy products and neosporin. Asthma and GI Reflux.			1						2	Choking; Cough; Dysphonia; Eczema; Fatigue; Hypersensitivity; Influenza like illness; Pain; Throat tightness; Wheezing; Condition aggravated; Cough; Dysphagia; Sinus operation; Throat tightness; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89126~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Life Threatening	Influenza
0333472	12/09/2008	PA	45.0	45		M	11/19/2008	Noted numbness around right side of mouth on 11/16 or 11/17/08. Seen by a doctor on 11/18/08 and diagnosed with Bell's Palsy. Treated with Prednisone, Famciclovir. Blood work drawn and MRI of brain ordered.				Y					U	11/06/2008	11/16/2008	10	Ordered by Dr	OTH	PVT		No	Heartburn			1						2	Blood test; Facial palsy; Hypoaesthesia oral; Nuclear magnetic resonance imaging brain; Blood test; Facial palsy; Hypoaesthesia oral; Nuclear magnetic resonance imaging brain	FLU3~SANOFI PASTEUR~U27751AA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U27751AA~1~UN~AR~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0333489	12/09/2008	GA	39.0	39		F	11/17/2008	Patient stated she got infection at injection site.  She went to urgent clinic & received antibiotic & pain med.  Is ok now.				Y					Y	10/08/2008				OTH	OTH						1						2	Injection site infection; Injection site infection; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aklla176a~2~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0555u~2~IM~LA~PNEUMO (PNEUMOVAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AGLLA176AA~2~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~2|PPV~MERCK & CO. INC.~0555U~2~UN~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0333558	12/09/2008	PA	1.3	1	.3	M	11/18/2008	He is giving throw two times seizure and he don't move his one side arm and leg. So I think he has big problem. You can get rep. from Dr. Thank You.				Y	Y	2			Y	10/28/2008	11/02/2008	5		PVT	UNK						1						2	Blood test normal; Computerised tomogram normal; Electroencephalogram; Pyrexia; Convulsion; Hemiplegia	FLU3~SANOFI PASTEUR~UT2787AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0357X~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0424X~1~SC~RA~VARICELLA (VARIVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|MMR~UNKNOWN MANUFACTURER~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~2|VARCEL~UNKNOWN MANUFACTURER~~UNK~UN~UN~VARICELLA (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0334255	12/09/2008	MD				U	11/14/2008	Erythematus, nodule									N	11/12/2008	11/17/2008	5		PVT	PVT						1						1	Erythema; Nodule	FLUN3~MEDIMMUNE VACCINES, INC.~500~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TDAP~SANOFI PASTEUR~C30332AA~1~IM~UN~TDAP (ADACEL)~1	USA		Influenza
0334258	12/09/2008	CO	45.0	45		F	11/10/2008	Patient started getting a red and dry throat the next day (10/3/08), and the back of her nose seemed to hurt. She started to feel real bad and sick in couple of days and she went to the doctor's office, and she was put on Amoxicillin. She ended up in the ER with so much pain, and they put her on DILAUDID. She felt better a little later and on 10/27/08, she was put on TAMIFLU. She is still trying to recover, but much better.				Y					Y	10/02/2008	10/03/2008	1		OTH	OTH		None				1						1	Dry throat; Feeling abnormal; Pain; Pharyngeal erythema	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0334259	12/09/2008	MD	54.0	54		F	11/14/2008	Papule started 1 day after flu injection, 2 1/2 from injection site, size 1 1/2x 1 1/4, erythematous, itchy. Size increased over 2 days. Injection date 11/12/2008, papule appeared 11/13/2008. Treatment, topical hydrocortisone cream.									U	11/12/2008	11/13/2008	1		PUB	PUB	None	None	Allergies; ADVIL; CELEBREX, mold; cigarette smoke; band aid			1						1	Pruritus; Rash erythematous; Rash papular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA172AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0334260	12/09/2008	MI	37.0	37		F	11/13/2008	Fever, headache, arm tingly and numb Hives, weak and sick									Y	10/08/2008	10/09/2008	1		OTH	OTH		None	none			1						1	Asthenia; Headache; Hypoaesthesia; Malaise; Paraesthesia; Pyrexia; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0334261	12/09/2008	AZ	69.0	69		F		High fever chills sore throat muscle aches muscle pain in hip right leg hard to bend leg knee pain									N	10/08/2008				PVT	UNK						1						1	Arthralgia; Chills; Myalgia; Oropharyngeal pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0334262	12/09/2008	FL	93.0	93		F	11/04/2008	I was given a flu shot on Wed 10/29/08 about 5:00 pm. That evening, I started to get a sore throat. I gargled with Listerine and took Cold EEZE. My throat improved but I had some fever and for two weeks I was fighting much nasal and bronchial congestion and aching. This is 11/13 and I'm a lit better but still have hangover phlegm. Also bought more Cold EEZE and Cold Flu Relief.			Y						Y	10/29/2008	10/29/2008	0		OTH	OTH	Just vitamins and baby aspirin	None	None			1						1	Increased upper airway secretion; Nasal congestion; Oropharyngeal pain; Pain; Pyrexia; Respiratory tract congestion	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89989~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening	Influenza
0334263	12/09/2008	CA	4.0	4		M	11/04/2008	Pt received FLUVIRIN ON 11/2/08 and then developed redness/ swelling at injection site later that day (1cm round) ((L) upper arm). Pt started treatment today.				Y					U	11/03/2008	11/03/2008	0		PVT	UNK		None	None			1						1	Injection site erythema; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88175P~4~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0334264	12/09/2008	VA	71.0	71		U	11/10/2008	Lesions, papule.										11/03/2008	11/05/2008	2	None	UNK	UNK	Proscar; Lupron; detrol	metastatic prostate cancer	metastatic prostate ca; S/P colectomy 2006			1						1	Rash papular; Skin lesion	FLU3~SANOFI PASTEUR~U2847AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334265	12/09/2008	DC	22.0	22		U	11/07/2008	Developed N/V, HA and myalgias after FLUMIST, SPV, and ANTHRAX. Went to ER, seen in MTF for the 2 days. Given symptomatic treatment. Symptoms resolved.										10/28/2008	10/29/2008	1	None	UNK	UNK	None	None	None			1						1	Headache; Myalgia; Nausea; Vomiting	ANTH~MICHIGAN DEPT PUB HLTH~FAV149~UNK~SC~~ANTHRAX (NO BRAND NAME)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500556P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~UNKNOWN MANUFACTURER~VV04003A~UNK~ID~~SMALLPOX (NO BRAND NAME)~1	USA		Influenza
0334266	12/09/2008	CA	92.0	92		M	11/01/2008	Difficulty breathing, hoarseness, wheezing, weakness and sweats all night(one night). Continuing through Nov 1(today). Today feel 70%.									U	10/16/2008	10/23/2008	7		OTH	OTH	Eye drops	None	None			1						1	Asthenia; Dysphonia; Dyspnoea; Hyperhidrosis; Wheezing	FLUX~UNKNOWN MANUFACTURER~~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0334268	12/09/2008	WA	55.0	55		F	11/08/2008	10/30/08: Shot given in AM almost immed felt tingling and numbness; at approx. 7:30pm, noticed 2 hard knots at inj. site: red and size of nickel. 10/31/08: woke up with large swollen area around inj. site measuring 4-5 inches in diameter, hot. By Monday-most swelling and redness gone									Y	10/30/2008	10/30/2008	0	None	OTH	PVT	VIVELLE dots-hormone patch; FOSAMAX; Rx for Vit D	None	allergy to sulfa	severe swelling~Smallpox (no brand name)~UN~4.00~Patient		1						1	Hypoaesthesia; Injection site erythema; Injection site induration; Injection site swelling; Paraesthesia	FLU3~SANOFI PASTEUR~U2763AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334275	12/09/2008	WI	0.5	0	.5	M	11/10/2008	Baby was coughing & gurgling (choking on excess saliva). Covered in hives. O2 levels were o.k., so paramedics allowed us to transport him to hospital. He was treated with antihistamines & released. He began to fall behind developmentally & has autism, epilepsy & tremors now.   12/15/08 MR received from PCP including allergy consult.  Pt developed cough, choking, facial redness and hives shortly after receiving vax. Resolved in ER with benadryl. Developmentall well at 6/16/06 WCC. Sleep issues noted 9/06. Febrile seizure 5/07.  By 6/18/07 more seizures noted as well as loss of speech. and spinning behaviors. Assessment: Well check. Speech delay. Placed on Keppra for grand mal seizures.  Tremors noted 11/07.  Multiple episodes of croup. ? asthma.				Y				Y	N	12/16/2005	12/16/2005	0	None that day. Later tests included EEGs, MRI. Labs and Diagnostics: eeg WNL.  MRI WNL.	PVT	PVT	ZANTAC	None	GERD; Ventricular septal defect; Undescended testicle. PMH: egg allergy. GERD. VSD. ASD. Undescended testicle			1						1	Autism; Choking; Cough; Developmental delay; Electroencephalogram; Epilepsy; Nuclear magnetic resonance imaging; Salivary hypersecretion; Tremor; Urticaria	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B037CA~3~UN~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U1743MA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE315AA~3~UN~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~A56117B~3~UN~LL~PNEUMO (PREVNAR)~1	USA	Disabling	Influenza
0334276	12/09/2008	OH	69.0	69		F	11/10/2008	Upper right arm began itching which spread to other arm and upper torso. Diagnosed as urticaria on 10.27.08. Treated with 9 day course of Prednisone 20mg tabs and Prilosec.									Y	10/16/2008	10/17/2008	1		OTH	PVT						1						1	Pruritus; Urticaria	FLU3~CSL LIMITED~02049111A~2~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0334277	12/09/2008	OH	85.0	85		F	12/02/2008	increased temp and generalized rash. Temp 102.7 on arrival to ED. Admitted and discharged back to nursing home 5 days later. Rocephin empirically. Stool, urine and Blood cultures no growth. Chest xray and ultrasound of kidneys unremarkable. 12/15/08-redords received for DOS 11/9-11/13/08-DC DX: Fever of unknown origin. Presented with fever and recent rash.				Y	Y	4			Y	11/07/2008	11/09/2008	2	no elevation of white blood cell count.  12/15/08-records received-CXR no acute disease. Ultrasound of kidney unremarkable. WBC 5.9. Blood cultures and urine cultures no growth.	OTH	OTH	ATENOLOL; LEVOTHYROXINE; OSTERSHELL with D; SEROQUEL; Triamterene/HCTZ; CITALOPRAM		NKA- Hx Dementia; HTN; hypothyroidism; Depression 12/15/08-records received-PMH:dementia, hypertension, hypothyroidism, depression, hard of hearing, agitation.			1						1	Body temperature increased; Culture stool negative; Rash generalised; White blood cell count normal	FLUX~UNKNOWN MANUFACTURER~89751~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0334279	12/09/2008	MT		67		F	11/07/2008	Pt. reports- tightness of chest, palm sized area of slight, diffuse swelling, reddened. Pt. took self admin. with BENADRYL. No medical treatment or dx tests required. Fever 101.									Y	10/31/2008	10/31/2008	0	None	PUB	OTH		None	Per pt. report: seafood; bees; nutmeg; some medications			1						1	Chest discomfort; Erythema; Pyrexia; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA375AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0334280	12/09/2008	NY	53.0	53		F	12/01/2008	11/10-ER visit-flushing of face, dizziness, chest pain, paraesthesia of both arms & face. 11/13-paresthesias of arms & legs, dizziness, lightheadedness near syncope disconnected feeling - Hospital admission 2 days.   12/15/2008  ER record received for DOS 11/10/20008 with DX: Chest pain r/o acute coronary syndrome. Dizziness. Pt presented with c/o dizziness, chest pressure and numbness in the arms.  PE WNL. D/C for outpt f/u of possible lung lesion.   12/31/2008 MR received for DOS 11/13-14/2008 with D/C DX:  Presyncope, lightheadedness, dizziness, hypertension and hyperlipidemia.  Pt returned to ER after a near syncopal event.  Continued to have lightheadedness. W/u (-).  Likely vasovagal event or possibly vertigo.				Y	Y	2			Y	11/07/2008	11/10/2008	3	Labs-Normal; ECHO (-); Carotid doppler (-); CT brain (-); MRI brain (-)  Labs and Diagnostics: EKG normal for pt with RBBB. CXR WNL.  Coronary CT of chest (+) for mild disease LAD, some scarring L lung base, aortic & coronary calcifications. CPK and CKMB WNL. Labs and Diagnostics:  EKG normal for pt. Echo (+) for trace mitral and tricuspid regurg, otherwise WNL. Brain MRI ENL.  MRI cervical spine (+) disc bulges. CT brain WNL.  Troponin  0.1. CBC unremarkable	PVT	PVT	SYNTHROID; ZEGERID; ECOTRIN; ZETIA; ZOCOR	None	hair dye allergy; Hypothyroid; Hypercholesterolemia; GERD . PMH:  GERD, hypothyroid, elevated cholesterol. NKDA			1						1	Chest pain; Computerised tomogram normal; Dissociation; Dizziness; Echocardiogram normal; Flushing; Laboratory test normal; Nuclear magnetic resonance imaging brain normal; Paraesthesia; Presyncope; Scan brain; Ultrasound Doppler normal	FLU3~SANOFI PASTEUR~U2832AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0334283	12/09/2008	TX	34.0	34		F	11/10/2008	At 1:10 p.m., headache, pupils pin point, eyes blood shot, heart rate up/down/hard, difficulty breathing, diarrhea. Rpt to DSHS 4 pm. Went home 4:15, took Nyquil and Excedrin, slept. No sx on awakening. Gets sever headache 1x/month.									Y	11/05/2008	11/05/2008	0		OTH	OTH			Gluten			1						1	Diarrhoea; Dyspnoea; Headache; Heart rate irregular; Miosis; Ocular hyperaemia	FLU3~SANOFI PASTEUR~U2810AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2865AA~6~UN~LA~TDAP (ADACEL)~1	USA		Influenza
0334286	12/09/2008	UT	5.0	5		F	11/10/2008	Pt. developed cellulitis of right lateral thigh 3 days after injection.  Redness 17 cm, knot, positive firm.				Y					Y	11/03/2008	11/05/2008	2		UNK	PUB						1						1	Injection site cellulitis; Injection site erythema; Injection site induration; Injection site mass	DTAP~SANOFI PASTEUR~C2955BA~5~UN~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2829AA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB260AA~2~UN~RL~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~A09962~4~UN~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~UNK~2~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~UNK~2~UN~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0334287	12/09/2008	UT	45.0	45		F	11/10/2008	10-23-08: Stiff neck, tingling of trigeminal nerve, sense of dread. 10-24-08: Increased tingling of face, all 4 extremities, trunk. ER visit 10-24. 10-27-08: Increase in symptoms, loss of sensation in a wave from mid shin, thigh and again up to waist. ER visit. 10-25-08 Admit to hospital, progressed to upper arm weakness. Extensive diagnostic work-up. IV SOLU-MEDROL x 3 days. Good response to steroids, remains with sensory dysathesias.  1/5/09-records received for DOS 10/24/08 and 10/28-10/31/08-DC DX: Possible vaccinal induced central nervous system postvaccinal autoimmune reaction. Presented with C/O multifocal dysesthesia and weakness. Postauricular pain, numbness, dizziness and left facial pain day prior. Electrical sharp shooting impulses down extremities mainly right side. Fully retained reflexes. IV steroid therapy. Developed respiratory distress, dysnpena and chest tightness. Ventricular tachycardia.			Y	Y	Y	4			N	10/16/2008	10/23/2008	7	All MRI: WNL; Spinal fluid negative for MS signs; EMG WNL; Blood work normal; Diagnosis - central demyelination s/p vaccination 1/5/09-records received-Nerve conduction studies unremarkable without  clear cut evidence for Guillain-Barre syndrome. Lumbar puncture negative. Echocardiography normal.	PVT	OTH	None	None	Allergic: Codeine, ALEVE			1						1	Anxiety; Blood test normal; CSF test normal; Dysaesthesia; Muscular weakness; Musculoskeletal stiffness; Nuclear magnetic resonance imaging normal; Paraesthesia; Sensory loss; Trigeminal nerve disorder; Demyelination; Hypoaesthesia; Intensive care; Laboratory test normal; Muscular weakness; Musculoskeletal stiffness; Nuclear magnetic resonance imaging normal; Paraesthesia; Sensory loss	FLU3~SANOFI PASTEUR~U2804AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2804A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0334289	12/09/2008	MA	66.0	66		F	11/10/2008	LUE swelling on evening of vaccines. Went to ER on 10/22/08. IV abx d/c'd home on Th 10/23/2008.  3/23/09 Received hospital medical records for 10/22-10/23/2008. FINAL DX: hypovolemic hyponatremia; symptomatic orthostasis; left arm vaccine site reaction; SIADH; DM; HTN; Parkinsonism. Records reveal patient experienced syncope, fatigue, UOP decreased, left arm swelling, warmth, redness & pain from Td & pneumo injection sites to midforearm x 1 day.  Improved w/IVF & antibiotics.  D/C to home on continued oral antibiotics w/PCP f/u of labs.				Y	Y	1			Y	10/21/2008	10/21/2008	0	Unknown  LABS: Na 121(L).  Hematocrit 34.6(L), neutros 91.2%(H), lymphs 5.7%(L).  Cardiac enzymes neg.  Serum osmo 260(L)	PUB	UNK			Insulin Dep Diabetic   PMH: obesity; HTN, hyperlipidemia, IBS, GERD, IDDM s/p pancreatitis, SIADH, MVP, left hand tremor, migraines, CCY & arthroscopic knee surgery.			1						1	Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~16790~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1|TD~MASS. PUB HLTH BIOL LAB~Td200~UNK~IM~LA~TD ADSORBED (TDVAX)~1	USA	Hospitalisation	Influenza
0334290	12/09/2008	IN	47.0	47		M	11/10/2008	Less than 1/2 hour after injection loss of cognitive ability slept 4 hours better next day. After 1 week sore throat and sore muscles, cough, sinus problem 3 days still having symptoms.									N	10/31/2008				PUB	PUB	None	None	None			1						1	Cognitive disorder; Cough; Myalgia; Oropharyngeal pain; Sinus disorder	FLU3~SANOFI PASTEUR~U2746AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334291	12/09/2008	WI	68.0	68		F	11/06/2008	Sore throat, chills, achiness, exhausted diarrhea, 10/30/2008. Better on Tues. 11/4/08.									U	10/27/2008	10/30/2008	3		PUB	PVT	For cholesterol and BP		Prediabetic; high cholesterol; hypertension			1						1	Chills; Diarrhoea; Fatigue; Oropharyngeal pain; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89622~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334292	12/09/2008	NY	8.0	8		M	11/11/2008	Seizure lasting more than 5 min. with incontinence & loss of consciousness.  Stupor with return of consciousness.  Transported by ambulance to hospital, then to other hospital. 1/15/09-records received for DOS 11/1-11/3/08- DC DX: Seizure-like activity; viral infection with fever. Presented with seizure-like activities. Jerking movements, shaking all over, head jerking backwards, eyes rolled toward back of head. Urinated on self. Unresponsive throughout the 5 minute activity. Lethargic. Blood pressure increased, heart rate increased, temperature elevated.  Vomited, drowsy and tired. PE: eczema.				Y	Y	2			Y	10/31/2008	10/31/2008	0	Abnormal EEG @ hospital per mother of PT.  Diagnosis of Epilepsy per mother.  1/15/09-records received-CBC, chemistry, chest x-ray, heat CT all negative. EEG: abnormal temporal slowing suggestive of seizure disorder. Blood and urine cultures negative.	PUB	PUB	None	Well child	ADHD per mother of child. No meds.  1/15/09-records received-PMH: asthma, ADHD, febrile seizures at age of 1, 3, and 5.			1						1	Convulsion; Electroencephalogram abnormal; Incontinence; Loss of consciousness; Stupor	FLUN3~MEDIMMUNE VACCINES, INC.~500548P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0334293	12/09/2008	OR	63.0	63		M	11/07/2008	Left cheek and left side of lower lip, numb, noticed pm of 10-11-08. Then noticed rash on waist and then lower back and groin area. Also swelling of penis foreskin for 2 days. Sunday 10-12-08 started noticing rash under arms. Swelling by left temple area on 10-14-08. Doctor visit on 10-15-08. Numbness on right cheek on the night of 10-14-08, this prompted me to call Doctor on the morning of 10-15-08. After exam in his office Doctor was fairly certain it was Hives.				Y						10/07/2008	10/11/2008	4		OTH	OTH	ATENOLOL, 100mg; LIPITOR, 40mg; Nifedipine, 30mg; SYNTHROID,125mg	None	None			1						1	Balanitis; Hypoaesthesia facial; Hypoaesthesia oral; Rash; Swelling; Urticaria	FLU3~SANOFI PASTEUR~NDC49281038215~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334294	12/09/2008	MN	46.0	46		F	11/04/2008	10/31/08 630 pm - diarrhea and nausea (all fine until then eating/drinking, sleeping all ok). Nausea increased, vomited 3x. Passed out, not sure for how long as alone. Vomited another couple times and again passed out; when this happened again she was home and husband took to ER. Give IV fluids and heart monitored. Received anti-seizure and anti-nausea meds.  3/3/09 MR received for DOS 10/31-11/1/2008 with D/C DX:  Neurocardiogenic syncope with prominent cardioinhibitory features.  Psoriatic arthritis.  Leukocytosis.  pt presented to ER after several episodes of syncope with nausea and vomiting. 1st episode pt was driving, became nauseous and passed out and fell while exiting the car. Awoke covering in emesis. 2nd episode was witnessed and pt vomited, became flaccid, lost consiousness and had circumoral and fingertip cyanosis. Loss of bladder control as well. PE (+) for contusion on R forehead otherwise WNL. Initially suspicious for seizure. One episode witness by neurologist w/o seizure activity. Systolic murmur noted by cardiologist. W/u for cardiomyopathy (-). No further w/u or tx at this time.				Y	Y	1			Y	10/30/2008	10/31/2008	1	Admitted to hosp. for a 24 hr. echo done for heart as well as blood tests. No probs. while in hospital. Labs and Diagnostics: WBC 19K. CXR WNL. Head CT (-). Echo WNL. Troponin (-). ECG WNL.	PUB	PVT		None	None . PMH:  Psoriatic arthritis.			1						1	Blood test; Diarrhoea; Loss of consciousness; Nausea; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA380CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0334295	12/09/2008	CT	45.0	45		F		Anaphylaxis: swelling, hives, BP decreased, heart rate increased, difficulty breathing, dizzy, nausea, vomiting, itching, faint. 12/23/08-records received-for DOs 10/30/08-DX-Allergic reaction. Anaphylaxis influenza vaccine. C/O flushed, vomiting, hives.			Y	Y					Y	10/30/2008	10/30/2008	0		UNK	PVT						1						1	Blood pressure decreased; Dizziness; Dyspnoea; Heart rate increased; Nausea; Pruritus; Swelling; Syncope; Urticaria; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Life Threatening	Influenza
0334296	12/09/2008	AL	3.0	3		M	11/18/2008	Fever, headache, vomiting, body aches, coughing.  12/30/08 MR received for DOS 11/14-17/2008 with D/C DX:  Fever, Vomiting with dehydration, Bronchitis, Bilateral OM, anemia. Pt presented with 4 day hx of fever, vomiting. Had been seen for cough 4 days prior and given Flumist.  PE (+) for TM infection, dry mouth and throat, rhonchi, tachycardia. Tx IV abx and nebs.				Y	Y	3			Y	11/10/2008	11/11/2008	1	Labs and Diagnostics: CXR WNL. CBC with WBC 8.5-22%lymphs. RBC 4.03, Hgb10, Hct 30.3. Na+, K+ and Cl all low. Flu and mycoplasma (-).  Abdominal US (-).  CXR Perihilar bronchial wall thickening.	PVT	PVT		Coughing	PMH: none			1						1	Cough; Headache; Pain; Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500583P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0334298	12/09/2008	IL	54.0	54		F	11/18/2008	Patient rec'd pneumonia vaccine right deltoid on 11/13/08.  Patient reports that she began with chills and body aches that evening which then led to dry heaves.  By 11/15/08 patient presented to ER with CELLULITIS at injection site.  She was hospitalized overnight.  Pt developed chest pain also.  12/19/2008 MR received for DOS 11/16-17/2008 with DX: Right upper extremity cellulitis and chest pain. Pt presented with swelling and pain in Rarm. Pt also developed chest pressure and R arm discomfort. PE (+) for RUE erythema, warmth and tenderness and shingles rash present prior to vax. Tx with abx and Valtrex for shingles.				Y	Y	2			Y	11/13/2008	11/13/2008	0	CBC; Chem 7; GFR; BUN; Troponin; CK; Culture; UA. Labs and diagnostics:  EKG WNL. Troponin 0.01. K+ 3.1. CBC with WBC 22.3, 16% bands. CXR WNL.	PVT	PVT	AVONEX	Herpes Zoster; MS	Multiple Sclerosis. PMH: splenectomy. MS			1						1	Blood creatine phosphokinase; Blood urea; Chest pain; Chills; Culture; Full blood count; Glomerular filtration rate; Injection site cellulitis; Laboratory test; Pain; Retching; Troponin; Urine analysis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA389BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0397X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0334303	12/09/2008	CT	56.0	56		M	11/09/2008	I encountered patient casually 4 days post vaccination, and he recounted how he had fever and the shakes that evening after receiving the flu shot. He was ok the next day. He said, he had had a previous reaction such as this 2 years before, last year was ok. His consent had a no answer to the previous rx question. He did not call MD.									Y	11/04/2008	11/04/2008	0		PUB	PVT						1						1	Pyrexia; Similar reaction on previous exposure to drug; Tremor	FLU3~SANOFI PASTEUR~U2752AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334304	12/09/2008	VA	6.0	6		M	11/06/2008	Right arm swollen and erythematous, about 10 cm mid upper arm, including injection site. Mother reports swelling and redness much less over last 2 days.									U	11/03/2008	11/03/2008	0		PVT	OTH		None	Asthma/Allergic Rhinitis; 5/08: Acute Myocitis			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2847AA~2~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334306	12/09/2008	OH	5.0	5		F	11/14/2008	Left arm red, irregular, & swollen.  Area is firm, slightly raised & warm to the touch.  Approximate size 3 finger breadths wide & long.  Mom will admin ADVIL or TYLENOL & apply ice as needed.									Y	11/13/2008	11/14/2008	1	NA	PUB	OTH	ZITHROMAX, ZYRTEC	Cough, stuffy nose	None			1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth	DTAP~SANOFI PASTEUR~U2356CA~2~IM~LA~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500558P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~A10602~2~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0147X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0334307	12/09/2008	MA	1.51	1	.5	M	11/13/2008	1. Red swelling induration 2 X 1 noted on right thigh.  2. Warm compress and observation. Right thigh lateral side red and swelling around DTap injection site, it is about 5 X 6cm with mild tenderness. Warm compress and observation									Y	11/10/2008	11/10/2008	0	None	PUB	PUB		None				1						1	Injection site erythema; Injection site induration; Injection site swelling	DTAP~SANOFI PASTEUR~U2355BA~4~IM~RL~DTAP (DAPTACEL)~1|FLUX~SANOFI PASTEUR~UT2707EA~3~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAV8216AA~2~IM~LL~HEP A (HAVRIX)~1	USA		Influenza
0334309	12/09/2008	DE	9.0	9		M	11/14/2008	Flu shot given 11/12/2008, patient admitted to Hospital 11/13/2008 for viral meningitis, still there today. Via mother's report.  1/14/09 Reviewed hospital medical records of 11/13-11/15/2008 FINAL DX: Viral meningitis Records reveal patient experienced HA, photophobia, fever, abdominal pain & vomiting x 1 day.  Neuro consult & LP done.  Tx w/IV antibiotics, IVF & pain mgt.  Improved & d/c to home w/PCP f/u.					Y	2			U	11/12/2008	11/13/2008	1	Unknown  LABS: CSF: WBC 135(H),(+) enterovirus, glucose 77(H).  CBC: WBC 18.3(H).  CSF & blood c/s neg.  CT head WNL.	PVT	UNK	Concerta / Adult Col	None	Asthma ADHD  PMH: eczema,learning disability.  Had been hospitalized for flu & dehydration 2002.			1						1	Meningitis viral	FLU3~SANOFI PASTEUR~U2795EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0334311	12/09/2008	ME	38.0			F	11/14/2008	Swollen, redness, hot, sensitive to touch and pain down front of arm, shoulder towards chest.									U	11/12/2008	11/12/2008	0		OTH	UNK						1						1	Erythema; Hyperaesthesia; Pain; Skin warm; Swelling	FLUX~UNKNOWN MANUFACTURER~02840AA~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0334313	12/09/2008	MS	64.0	64		F	11/12/2008	10-27-08 approx 9:00 pm severe Rt arm/neck pain 1st, complete skeletal pain-joint, long bone, muscle pain, no sleep. 10-28-08 am increased fever 101 deg to 102.7 deg TYLENOL, 2 tab every 3 hrs, arm pain with x2 swelling-severe redness Rt arm injection sites and shoulder to elbow. 10-29-08 temps increased 102 deg, began breaking 12:00 pm-2:00 pm decreased 98 deg and up nights with greater swelling and redness Rt arm with pain. Amoxicillin by physician cellulitis, begin 10-30-08 - 11/8/08 over all gradual complete 11/10									Y	10/27/2008	10/27/2008	0	post vaccine-none 10/27/08 Lab prior to on day of vaccines	PVT	UNK	None	No primary	CIPRO sun exposure fixed; no birth defects; old breast CA 1998-None since			1						1	Arthralgia; Bone pain; Cellulitis; Injection site erythema; Injection site swelling; Insomnia; Myalgia; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0334314	12/09/2008	CA		0	.0	M	11/11/2008	Emergency Room Doctor from hospital called that patient had a febrile seizure. His temperature at the hospital was 100.7. No tests run.  1/16/09-records received for DOS 11/5/08-presented to ED with C/O single seizure just prior to arrival. Lost consciousness and was unresponsive, generalized motor activity observed. Fever 101.3. Tachycardic. Impression: Febrile seizure.								Y	Y	11/04/2004	11/05/2008	1462	None	PVT	UNK	None	No	No			1						1	Body temperature increased; Febrile convulsion	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC148087AA~5~IM~LA~DTAP (INFANRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500567P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~A11092~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1	USA	Disabling	Influenza
0334315	12/09/2008	FL	50.0	50		M	11/10/2008	Symptoms occurred 1 hr after vaccine given. Diaphoretic, paleness, weakness including legs giving out, dizziness, itching.				Y						11/05/2008	11/05/2008	0		PVT	UNK		None	IVP Dye; HTN; GERD; Mitral Valve Regurgitation			1						1	Asthenia; Dizziness; Hyperhidrosis; Pallor; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA357AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0334317	12/09/2008	CA	56.0	56		U		Got flu shot 3pm 11/18/08.  8 hrs. later suddently became light headed, heart rate increased from 60 to 90, blood pressure from 125/75 to 200/95.				Y					U	11/18/2008	11/18/2008	0	Blood pressure: normal 125/75; increased to 200/95; EEG at hospital-normal	OTH	PVT			None			1						1	Blood pressure increased; Dizziness; Electroencephalogram normal; Heart rate increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89994~1~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0334318	12/09/2008	CA	17.0	17		F	11/17/2008	Fatigue, (R) lung collapse necessitating mechanical ventilation thought possibly due to Guillain-Barre Syndrome, although no LP done, MRI not conclusive. Still under investigation at hospital. 1/13/09-records received for DOS 11/5-12/20/08-DC DX: Pneumonia and pleural effusion. Neuromuscular disorder.  Presented with 3 week history of jerking movements as well as weakness of legs. Required mechanical ventilation. Video swallowing studies showed pooling of fluid in vallecula with incomplete emptying. TachycardicTreated with IVIG and plasmapheresis.			Y		Y	45			N	10/21/2008	11/05/2008	15	Diagnosis still pending at hospital.   1/13/09-records received-. CXR significant bilateral infiltrates right pleural effusion. EEG normal. jerky movements possible due to myasthenia gravis verus an inflammatory myopathy. Anticholinesterase antibodies pending.	PVT	PVT	PREVACID, Mirtazapine 1/4 tab	Mild URI	VACTERL; TEF repaired; esophageal dysmotility; G-tube; asthma 1/13/09-records received-PMH: VATER syndrome. Double outlet right ventricle, status post repair. Tracheoesophageal fistula, status post repair. Gastroesophagel reflux. Asthma. Depression.			1						1	Collapse of lung; Fatigue; Mechanical ventilation	FLU3~SANOFI PASTEUR~U2808AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0334320	12/09/2008	MI	1.6	1	.6	F	11/17/2008	Stomatitis, posterior lesion seen 10-20-08 in office. Symptomatic Rxment improved. Came in 10-31-08 for scheduled Flu immunization seen by nurse, well -> gave immunization: 3 days later ataxia, seen at ER. Admitted-MRI +ve ADEM, hospitalized 11 days. I.V. steroid, acyclovir.   12/16/08 MR received for DOS 11/4-15/2008 with DX:  ADEM. Pt presented with fever, decreased appetite, and ataxia.  PE (+) for a fussy, sick looking irritable pt. Mild dehydration and refusal to walk. Pustule noted on L buttock. No ataxia reported in initial H&P. Admitted to r/o encephalitis. Neuro consult with Dx: ADEM presents with ataxia, somnolence, irritability, R facial palsy, Babinski's sign and brisk DTRs. Tx with abx, steroids, IVIG with improvement.				Y	Y	11			N	10/31/2008	11/03/2008	3	Viral culture negative; MRI brain positive ADEM; spine negative. Labs and Diagnostics:MRI Lumbar spine  WNL.  MRI thoracic spine with abnormal signal T2.  MRI cervical spine (+) for abnormal signal C7.  MRI brain c/w ADEM.  Abd X-ray c/w constipation.  Head CT (+) for maxillary sinus thickening. LP with CSF protein 82, CSF glucose 70, CSF IgG 15.1, CSF albumin 90.5. CSF WBCs 25-100% monos. CSF cx (-). Blood cx (-). Wound cx (+) for staph.RBC(+). No oligoclonal bands. SGOT 57, SGPT 94.  CBC with WBCs WNL on admission-up to 26.8 on 11/12/08. EBV, CMV, Flu, Mycoplasma, Entervirus (-).	PVT	PUB		Stomatitis 11 days prev./resolved	PMH: recent Hand, Foot & Mouth disease. Febrile seizure. Ear tubes			1						1	Acute disseminated encephalomyelitis; Ataxia; Nuclear magnetic resonance imaging brain abnormal; Spinal X-ray normal; Virus culture negative	FLU3~SANOFI PASTEUR~UT2792CU~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0334321	12/09/2008	OR	58.0	58		M	11/05/2008	Swelling of throat and ears with severe tinnitus in left ear which was followed by tinnitus in right ear. The right is still ringing as of 11/13/08.  3/5/09 Received vaccine records & PCP medical records for 10/29/2008. FINAL DX: tinnitus Patient reported via phone call that he developed tinnitus same day as vaccine & then developed nasal/head congestion & chilld on 10/29.  No reaction to previous flu shots. No MD visit. 02/01/2010 Tinnitus especially bad in the right ear (in both ears).								Y	N	10/27/2008	10/27/2008	0		PVT	OTH		None	M.I.	~Influenza (Seasonal) (no brand name)~UN~58.00~Patient		1						1	Auricular swelling; Pharyngeal oedema; Tinnitus; Tinnitus	FLUX~UNKNOWN MANUFACTURER~881171P~6~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0334324	12/09/2008	AZ	78.0	78		M	12/05/2008	After receiving flu shot about 3 days after had numbness on lunar side (pinky side ) of left hand.  Has remained the same.  Was out of country for 3 weeks & now still has the numbness & tingling in the left pinky.  Went to doctor.				Y					U	09/23/2008	09/26/2008	3	Went to doctor	PUB	PVT		None	None			1						1	Hypoaesthesia; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~155AAJN09~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0334325	12/09/2008	NE	51.0	51		F	12/02/2008	Achy on day of injection then noted tingling burning from lateral aspect of scapula thru shoulder down (L) arm thru lateral aspect of elbow joint continuing down arm thru to pulmar side of hand- numbness and tingling- tried hot/cold compresses, Tylenol, aleu, Ibuprofen Repostan no relief.				Y					N	11/21/2008	11/22/2008	1	To Dr- got kennalog inject ordered PT with electrical stem	PVT	OTH	Lexapro 10mg g D	None	None			1						1	Burning sensation; Hypoaesthesia; Pain; Paraesthesia	FLU3~SANOFI PASTEUR~42849AC~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334326	12/09/2008	AZ	70.0	70		M	12/05/2008	Tingling followed by pain in fingers of left hand followed by a lot of pain & swelling in left hand & arm.  Hand remained swollen especially at night & tends to quiet during the day-  less pain & swelling.  Gets severe at night a comes & goes several times during nite.  Seems to be getting better at ct less episodes at night but still under doctors care. Conts to have pain-under doctors care.				Y					U	10/05/2008	10/07/2008	2	MRI, CT	PUB	PVT						1						1	Computerised tomogram; Nuclear magnetic resonance imaging; Oedema peripheral; Pain in extremity; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~06109~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0224X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0334328	12/09/2008	KS	22.0	22		F	11/28/2008	Generalized itching- small bumps on arms and chest advised pt to take Benadryl sx appeared at 8:45pm.									U	11/28/2008	11/28/2008	0		PUB	PVT	None	Mild congestion	None			1						1	Pruritus generalised; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0334329	12/09/2008	NC	54.0	54		M	12/04/2008	Pt received vaccine on 11/4 & called on 12/3 to report that his arm was continuing to feel tender & appeared to be swollen.  His MD has been notified.									U	11/21/2008	11/21/2008	0		OTH	OTH	DIOVAN;  OMOPRAZOLE;  VIT; MG; FE; FLOMAX; Fish Oil; VICODIN	No	Allergies, TETRACYCLINE;  PMH, HTN, BPH			1						1	Oedema peripheral; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89999~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334331	12/09/2008	KY	65.0	65		F	11/19/2008	Patient got flu + pneumonia vaccine in left arm 11/13/08.  Arm became red the following day and gradually worsened and became swollen.  Patient went to primary care physician who sent to hospital.  It was originally thought to be MRSA but was eventually determined to be Cellulitis.  Required surgical draining of tissue.  12/23/08 Reviewed hospital medical records of 11/15-11/16/2008. FINAL DX: Cellulitis  Records reveal patient experienced left arm redness, swelling & pain along w/nausea & fever day after receiveing both vaccines in left arm.  Saw PCP & tx w/oral antibiotics.  Condition worsened & admitted for IV antibiotics.  Taken to OR for exploration, I&D done.  Improved markedly s/p surgery & d/c to home on continued oral antibiotics.					Y	2			Y	11/13/2008	11/14/2008	1	LABS: WBC 17.3(H), potassium 2.9(L).  MRI left arm revealed possible necrotizing fasciitis	OTH	PUB	LEVOTHYROXINE; DYAZIDE	None	Iodine allergy  PMH: hypothyroidism, HTN.  Spouse w/recent MRSA infection.			1						1	Surgery	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89987~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1161X~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0334333	12/09/2008	CA	44.0	44		F	11/21/2008	Stomach pain, emesis, uncontrollable chills and headache. Temperature increased to 101.6 from normal over 2 hours despite TYLENOL.									Y	11/17/2008	11/17/2008	0		UNK	UNK		None	Morphine; DEMEROL; history of Chemotherapy, currently in good health			1						1	Abdominal pain upper; Body temperature increased; Chills; Headache; Vomiting	FLUX~SANOFI PASTEUR~U2759AA~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0334335	12/09/2008	OH	0.7	0	.7	M	12/03/2008	Fever to 104 7 TMNX fever started day of vaccines - 103 first night / 104 7 next night - referred to ER by our office - leg swelling and pain (L thigh)				Y					U	12/01/2008	12/01/2008	0	CBC 7.2 > 38.2 < 328 72.55 18.1 L, BLX - Ng times 12 hour	PVT	PUB	AMOXICILLIN		Otitis media, tracheobronchitis improved			1						1	Blood culture negative; Full blood count; Injection site pain; Injection site swelling; Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B167AA~1~UN~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~VT27881A~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~VF520AA~3~UN~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C73446~3~UN~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0334336	12/09/2008	WA	63.0	63		M	12/03/2008	Redness, swelling, fever muscle ache developed 2hr after injection.									U	12/02/2008	12/02/2008	0		PVT	PVT		None	Seasonal Allergies			1						1	Erythema; Myalgia; Pyrexia; Swelling	FLU3~CSL LIMITED~02049111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~0870X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0334337	12/09/2008	NE	24.0	24		F	11/20/2008	Rash on forearms- both arms - worse on arm vaccinated.									U	11/16/2008	11/17/2008	1		OTH	OTH	Unknown	Unknown	Unknown			1						1	Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89994~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334340	12/09/2008	WA	17.0	17		F	11/20/2008	1 d. after received Influenza vaccine and MENACTRA, pt developed nausea/HA/chills. HA persisted for 1 week, mild and nagging. seen 11/20/08. Discussed possibility of non-vaccine related causes. F/u planned. HA not resolved yet.									U	11/11/2008	11/13/2008	2	Influenza (-); sinus XR (-)	PVT	OTH		None known	None			1						1	Chills; Headache; Influenza serology negative; Nausea; X-ray normal	FLUX~SANOFI PASTEUR~U2808AA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MNQ~SANOFI PASTEUR~U2814AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0334341	12/09/2008	FL	2.0	2	.3	F	12/02/2008	Cough and fever 2 days after FLUZONE Imm.				Y					Y	11/24/2008	11/26/2008	2		PVT	UNK		FTT	None			1						1	Cough; Pyrexia	FLU3~SANOFI PASTEUR~UT2799FA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB789AA~2~IM~RL~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0334343	12/09/2008	RI	0.5	0	.5	F	11/21/2008	Within hours of vaccines, patient began with involuntary movements of head and lip smacking, back arching and jerking motions of arms. Temp 101.8. Admitted to hosp. to R/O seizure. Thought to be secondary to vaccines. 1/15/09-records received for DOS 11/8-11/10/08- DC DX:Involuntary jerking movement. Lip smacking. Presented to ED with intermittent jerking movements,head to left. Lip smacking. Temperature 101.8, irritability.					Y	2			U	11/07/2008	11/07/2008	0	EEG, negative; Optho exam, nl; neurology consult 1/15/09-records received-EEG normal. Blood culture no growth.	PVT	PUB	None	None	None			1						1	Dyskinesia; Electroencephalogram normal; Head titubation; Neurological examination; Ophthalmological examination normal; Opisthotonus; Tardive dyskinesia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B192DA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2787AA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~VF445AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~040031~3~UN~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0595X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0334344	12/09/2008	MN	41.0	41		M	11/16/2008	Urticaria pruritis and shortness of breath.				Y					Y	11/16/2008	11/16/2008	0	Physical exam only	MIL	MIL						1						1	Dyspnoea; Pruritus; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500563P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0334348	12/09/2008	MI	0.7	0	.7	F	12/02/2008	Fever, variable between 100.1 & 102.5 on the same day as shots, also runny nose cough.									Y	11/24/2008	11/24/2008	0		PVT	UNK		eye drainage				1						1	Cough; Pyrexia; Rhinorrhoea	DTAP~SANOFI PASTEUR~U2397CA~2~IM~RL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2762AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~13710~3~IM~RL~HEP B (RECOMBIVAX HB)~1|HIBV~SANOFI PASTEUR~UF362AA~2~IM~RL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~A6492~2~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~C73446~2~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0334349	12/09/2008	MN	62.0	62		F	11/25/2008	Induration, half dollar coin size at site of injection.									U	11/24/2008	11/25/2008	1	None	PVT	PVT			HTN (hypertension)			1						1	Injection site induration	FLU3~SANOFI PASTEUR~U2797CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0287U~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TD~SANOFI PASTEUR~U1959BB~2~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0334351	12/09/2008	PA	61.0	61		M	11/21/2008	Had hives over body.				Y					Y	11/10/2008	11/10/2008	0		OTH	UNK						1						1	Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0334352	12/09/2008	RI	6.0	6		M	11/29/2008	Patient developed a scarlatini form line rash after receiving five vaccines and eating gelatin almost simultaneously.  Rash occurred within 1 hour.									Y	11/24/2008	11/24/2008	0	Throat culture;  Rapid strep negative throat culture pending.	PUB	PUB	None	None	None			1						1	Culture throat; Rash scarlatiniform; Streptococcal identification test negative	FLU3~SANOFI PASTEUR~U2831AA~5~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334353	12/09/2008	CA	5.0	5		M	12/04/2008	Fever, flu like illness 3 hrs after vaccination				Y					Y	11/02/2008	11/02/2008	0		PVT	PVT	None	None	None			1						1	Influenza like illness; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLVA358BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0334354	12/09/2008	NY	30.0	30		M	11/26/2008	Pt said he felt like his heart was racing. He looked pale, just after receiving the flu shot. He was asked to lay down. his pulse  and BP were checked  P62 - BP 136/70. He was alert and oriented. Rested awhile, sat up, sipped some water, sat and stood for awhile while been observed. Felt okay to go home.									Y	11/26/2008	11/26/2008	0		PUB	OTH		None known	None known			1						1	Heart rate normal; Pallor; Palpitations	FLU3~SANOFI PASTEUR~U2766AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334355	12/09/2008	WV	57.0	57		M	11/20/2008	11/9 Dizziness and weakness 2 days after vaccination by 4pm on the 9th felt better. Experienced same symptoms plus light headedness & body aches on 11/11/08 x2hrs, then felt better, BP WNL 132/75 at home. HX of receiving flu shot in past w/ no RXNS.									Y	11/07/2008	11/09/2008	2	None	OTH	PVT	Celebrex; Zocor; Maxide; Lisinopril	None	HTN			1						1	Asthenia; Blood pressure normal; Dizziness; No reaction on previous exposure to drug; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA188AA~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0334356	12/09/2008	MN	76.0	76		F	11/20/2008	Itching developed 5 hrs after injection around site of TD.  Then, about 12 hrs. after injection pain started, and then 24 hrs. after injection redness, warmth, and swelling developed.  Local reaction suspected but cellulitis could not be ruled out so VEFLEX were given for 10 days.									U	11/19/2008	11/20/2008	1	None	PVT	UNK		None	Hypertension;  Hyperlipidemia;  CAD;  Impaired glucose tolerance			1						1	Injection site erythema; Injection site pain; Injection site pruritus; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2789AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0397X~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U2067AA~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0334358	12/09/2008	WA	61.0	61		F	11/24/2008	Patient felt like waves of heat came over her, all over body.  Could not feel her legs yet she could ambulate.  Numbness in hands and legs lasted 30 seconds.  Says vision blurry and has temporary memory loss for 10-60 seconds.  She had 8-10 episodes in 1 1/2 hours.  Temperature 98.2, Pulse 92, Blood Pressure 156/82, BG 210mg/dl.  Sent to ED.				Y					Y	10/16/2008	10/16/2008	0		OTH	PUB	Lumigan - eye drops; Claritin	No	Glaucoma			1						1	Amnesia; Blood glucose increased; Body temperature; Feeling hot; Heart rate normal; Hypoaesthesia; Vision blurred	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA159AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0334360	12/09/2008	AZ	4.0	4		M	11/17/2008	Hives around injection site - Treatment Benadryl prn.									Y	11/12/2008	11/13/2008	1	None	PVT	PVT	None	Cough/ST/URI				1						1	Injection site urticaria	FLU3~SANOFI PASTEUR~U2767AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334362	12/09/2008	IN	61.0	61		F	11/22/2008	4 hrs after flu shot - wheezing, coughing, red eyes. 9 hrs after flu shot - All symptoms of the flu including fever of 100.8 - stuffiness in nose and sinuses - restless night. 22 hrs after flu shot - no symptoms - back to normal health.									Y	11/10/2008	11/10/2008	0	None	PUB	OTH	None	None except reaction to flu shot	None			1						1	Cough; Influenza; Nasal congestion; Ocular hyperaemia; Pyrexia; Restlessness; Wheezing	FLUX~UNKNOWN MANUFACTURER~~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0334363	12/09/2008	CA	48.0	48		F	11/19/2008	Swelling, some pain, stiff can't move a lot. Left arm.									N	11/17/2008	11/17/2008	0		OTH	PVT	None	None	Seasonal Allergies			1						1	Mobility decreased; Musculoskeletal stiffness; Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89989~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334364	12/09/2008	FL	29.0	29		M	11/12/2008	Headache within 10 minutes of injection. Dizziness, developed SOB and was advised by EMS to go to hospital. C/O SOB at 7 pm - no other signs of allergy - EMS took to hosp.				Y					U	11/12/2008	11/12/2008	0	BP and Pulse OX readings good per EMS	OTH	PVT	Klonopin; Ambilify; Cymbalta; Lexapro; Cosentin		PCN; Depression/Anx			1						1	Blood pressure normal; Dizziness; Dyspnoea; Headache; Oxygen saturation normal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89968~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0334365	12/09/2008	MN	76.0	76		M	11/05/2008	Came in 11/4/08 @ 5pm to vote and show me his arm had usual mild pain from shot then on Mon 10/27 started to get red rash it seemed swollen. We was fishing for a few days so did nothing. Rash worsened- got blisters and down arm. (flexor surface mainly). One patch ^3 diameter on red base lesion coalesced and blisters flattened and look like white plaques now. Also has a patch 2 red papules. Referred to MD-ER staph or strep infection. ? shingles cellulitis. Don't feel related to flu shot.				Y						10/24/2008	10/27/2008	3	Call med and found to be shingles.	PUB	PVT						1						1	Blister; Herpes zoster; Pain in extremity; Rash erythematous; Rash papular; Swelling	FLU3~SANOFI PASTEUR~U2766AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334367	12/09/2008	MD	41.0	41		F	11/23/2008	Started w/ coughing to clear throat losing voice some trouble getting a full breath. About an hour later started w/ body aches, sore throat fever, stuffed nose. Pale and swelling under eyes. Took Benadryl and Ibuprofen. Felt mostly better the next day.									Y	11/21/2008	11/21/2008	0		UNK	UNK		None	None			1						1	Aphonia; Cough; Dyspnoea; Eye swelling; Nasal congestion; Oropharyngeal pain; Pain; Pallor; Pyrexia	FLU3~SANOFI PASTEUR~U2753AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334369	12/09/2008	TN	17.0	17		F	12/02/2008	Received flu vaccine 11-24-08; c/o fatigue, behavior changes begging 11-27-08 in AM that worsened until 11-30-08 in pm. C/O began to slightly improve beginning 12-1-08. Pt. has been afebrile entire time.									N	11/24/2008	11/27/2008	3	None	PUB	PUB	Unknown	None	Mental Retardation with probable CP			1						1	Abnormal behaviour; Fatigue	FLU3~SANOFI PASTEUR~U2810AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334372	12/09/2008	MD	62.0	62		F	12/04/2008	Twelve hrs after vaccines, had dry cough, 4 days later progressed to chest pain, seen at hospital, CXR showed pneumonia ; and shingles rash developed (L) abdomen. The day she was seen for pneumonia! Both diagnosed by doctor.				Y					Y	11/12/2008	11/12/2008	0	chest xray, exam	PVT	PVT	LIPITOR, PREVACID, ZIAC, ALTACE, OTC PRV	None	HTN, DM, hyperlipidemia, GERD, asthma, diverticulosis	given flu~Vaccine not specified (no brand name)~UN~30.00~In Patient|bad reactions~Vaccine not specified (no brand name)~UN~0		1						1	Chest X-ray; Chest pain; Cough; Herpes zoster; Pneumonia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA154AA~3~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|VARZOS~MERCK & CO. INC.~1415X~1~UN~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0334373	12/09/2008	WV	44.0	44		F	11/20/2008	Approx. 2 hrs after receiving vaccine, pt. reported c/o weakness, vision changes, and ligthheadedness. BP checked and 150/90's. Went to urgent care, BP rechecked 140/87, and was sent to ER. Started feeling better and BP decreased to 130/79, pt. sent home. Pt. reports having received flu shot in past without any problems or reactions.				Y					Y	11/07/2008	11/07/2008	0	None	OTH	PVT	None	None	Heart Murmur			1						1	Asthenia; Blood pressure increased; Dizziness; Visual impairment	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA188AA~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0334374	12/09/2008	OH	72.0	72		F	11/03/2008	Administered FLUVIRIN five min later pt complained of tongue swelling and SOB. Administered Epi- Pen. Sx resolved called MD next day.									Y	11/03/2008	11/03/2008	0		OTH	PVT	Thyroid armar D.Sgr	None	None			1						1	Dyspnoea; Swollen tongue	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334375	12/09/2008	WI	76.0	76		F	11/26/2008	For 3hrs pt c/o SOB, dizzy, sharp pains in head, shaking a lot. Sx went away when taking Clonazepam and COMBIVENT									Y	11/11/2008	11/11/2008	0		PVT	PVT	Glucosamine, PEPCID, DIOVAN, COMBIVENT, Clonazepam	Foot pain, swelling (-) fx	WKDA			1						1	Dizziness; Dyspnoea; Headache; Tremor	FLU3~SANOFI PASTEUR~02759AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334378	12/09/2008	TX	1.0	1	.0	M	11/13/2008	Patient returned to clinic today with rash at varicella vaccine site. Left anterior thigh with patch of vesicles on red base.									Y	10/29/2008	11/13/2008	15	Herpes Zoster	PVT	PVT	None	None	Allergy - Iron, eczema			1						1	Herpes zoster; Injection site erythema; Injection site rash; Injection site vesicles	FLU3~SANOFI PASTEUR~UT2798HA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB289CB~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1208X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C69205B~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1144X~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0334379	12/09/2008	TX	0.5	0	.5	M	11/13/2008	Mom states - The day after the flu shot he started to swell all over.  No respiratory distress or wheezing.  Also developed a fine, red rash.  Mom gave Benadryl and went to ER.  Rash and swelling went away that same day.  Mom states she knows what hives look like and was not hives.				Y					Y	10/07/2008	10/08/2008	1	None	PVT	PUB	Nystatin oral susp; Prevacid	Thrush	GER Dacrostenosis			1						1	Rash erythematous; Swelling	FLU3~SANOFI PASTEUR~UT273GA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334380	12/09/2008	OH				M		Diarrhea, dehydrated, nausea, vomit, dizzy.				Y					Y	10/15/2008	10/17/2008	2		PUB	PVT		None				1						1	Dehydration; Diarrhoea; Dizziness; Nausea; Vomiting	FLUX~UNKNOWN MANUFACTURER~~4~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0334381	12/09/2008	UT	67.0	14		M	12/01/2008	See attached info. provided by client.				Y					Y	11/03/2008	11/03/2008	0	STEVEN JOHNSON SYNDROME	PUB	PVT		None				1						1	Asthenia; Chills; Fatigue; Headache; Hyperhidrosis; Myalgia; Oedema peripheral; Oral pain; Oropharyngeal blistering; Pain in extremity; Paraesthesia; Rash erythematous; Skin exfoliation; Stevens-Johnson syndrome; Weight increased	FLU3~SANOFI PASTEUR~U2804AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0867R~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0334383	12/09/2008	NJ	7.0	7		M	11/25/2008	Trouble breathing and pale. Patient has history of asthma is on XOPENEX and had URI(upper respiratory infection) and slight change prior to the VARIVAX.									Y	11/24/2008	11/24/2008	0		PVT	OTH	ALBUTEROL	URI ( upper respiratory infection )	Asthma			1						1	Dyspnoea; Pallor	FLU3~SANOFI PASTEUR~U2849AC~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAUB330AA~UNK~UN~UN~HEP A (HAVRIX)~1	USA		Influenza
0334384	12/09/2008	IN	1.0	1	.0	M	12/02/2008	Bruising over skin, forehead, lower arms. Smaller petichiae lower extremities. Hospitalized 12/01/08.  2/5/09 Received PCP medical records of 11/26/07-12/1/2008. Records reveal patient in usual state of health on 11/11/08.  RTC 12/1 w/bruising all over body starting 11/29.  Appetite & energy normal.    2/13/09 Received hospital medical records of 12/1-12/7/2008 & 12/19-12/24/2008.  12/1-12/7/2008 FINAL DX: thrombocytopenia; multiple bruises & petechiae. Records reveal patient experienced excessive & increasing bruising x 2 days prior to admit.  In hospital, developed fever & vomiting.  Tx w/IVIG, steroids & helmet.  12/19-12/24/2008 FINAL DX: left pneumothorax; staph aureus pneumonia. Records reveal patient experienced grunting respirations & rapid breathing.  Admitted to PICU & chest tube placed emergently.  Bronchoscopy done to r/o foreign body, none found but purulent material suctioned from LLL bronchus cultured & revealed staph aureus.  On 12/22 taken to OR for thoracoscopic pleural space debridement.  Findings included left empyema thoracis.  Tx w/IV antibiotics.  Chest tube d/c 12/23.  ID consult done.  D/C to home on continued oral steroids & oral antibiotics.									U	11/11/2008	11/29/2008	18	Platelet Count < 5,000  12/1 LABS: plts <5,000 on admit & 36,000 on d/c.  Plts on 12/15 317,000.  Bone marrow biopsy 12/5/08 WNL.  12/19 LABS: WBC 44.8(H), plts 349(N), segs 76%(H), lymphs 14%(L). Blood c/s neg. CXR abnormal w/large pneumothorax.  CT chest revealed left pleural effusion.	PVT	PVT	None		PMH: 36 wk preemie twin B, feeding problem, frequent URIs, OM.			1						1	Contusion; Petechiae; Platelet count decreased	FLU3~SANOFI PASTEUR~UT2783FB~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1210X~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C68312~4~IM~RA~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1148X~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0334385	12/09/2008	MN	6.0	6		F	11/20/2008	PPV 23 and flu vaccine given 10:00 AM on 11/18/08. On set of fever (101 ear canal), pain, induration, erythema measuring 16 cm top to bottom and 13 cm side to side. PPV 23 injection site 3 cm distal to top margin, flu site 1 1/2 cm distal to top margin.				Y					N	11/18/2008	11/19/2008	1		PVT	OTH		None	Celiac Disease			1						1	Erythema; Induration; Pain; Pyrexia	FLU3~SANOFI PASTEUR~0980X~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~U27930A~4~IM~RL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0334388	12/09/2008	WV	41.0	41		M	11/20/2008	Approx. 1-2 hrs after receiving the flu vaccine, pt. experiencing heart palpitations, dizziness, and generalized weakness. BP elevated to about 140/90. Pt. had Hx. of recent bronchitis and on last day of antibiotic, of which could not remember the name. Pt. states went to cafeteria to eat and then felt better, later that day. Pt. called and f/u with Dr., but did not see physician. 11/20, pt. called back and was on a Z-pack.									Y	11/07/2008	11/07/2008	0	Increase BP about 140/90	OTH	PVT	Z-pack; ZOLOFT; MV; Ca+; Mg	Bronchitis	Environmental allergies; no Hx of HTN			1						1	Asthenia; Blood pressure increased; Dizziness; Palpitations	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLA188AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0334389	12/09/2008	VA	62.0	62		F	11/05/2008	In (R) deltoid at vaccination site, a 1 1/2 diameter area- tender erythema, indurated w/o warmth. Pt c/o ache in arm for 4 days- on Nov 5, 08 at clinic states is smaller now. Prescribed on 11/5/08 BENADRYL 25 BID X 1 Wk, TYLENOL PRN and cool compresses and RTC in 1 wk for evaluation. Temp 98 degree									Y	11/01/2008	11/01/2008	0		OTH	OTH	Hydrochlorothiazide, CELEBREX, PREVACID, Lisinopril,	None	Latex, Soy			1						1	Injection site erythema; Injection site induration; Injection site pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA166AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1076X~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0334390	12/09/2008	MI	64.0	64		F	11/20/2008	Received an influenza & pneumonia on 11-13-08. Patient called on 11-19-08 to state she developed 101.5 fever, arm soreness and redness from 8X4 area including armpit 8 hours after lasting 2.5 days.									Y	11/13/2008			None	PVT	PVT	See attached	None	Allergy PCN, Sulfa, Codeine, Niapan			1						1	Erythema; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~U2771AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1541U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0334391	12/09/2008	ME	34.0	34		F	12/02/2008	(R) Sc tissue hot to touch, reddenned. Antibiotics given/BENADRYL										11/04/2008	11/04/2008	0	None	PVT	PVT		None	None			1						1	Erythema; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88637~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|MMR~MERCK & CO. INC.~0239X~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TDAP~SANOFI PASTEUR~C3030AA~UNK~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0334392	12/09/2008	PA	65.0	65		F	11/25/2008	Skin became itchy around site of shot (left arm) within 2 hrs. Arm became very sore by late afternoon, Noticed considerable swelling, redness. Heat the next morning, returned to normal by 11-21. Got flu shot in right arm had temperature and chills early evening until next day use ice and take pain reliever.									Y	11/18/2008	11/18/2008	0		PVT	OTH	None	None	None			1						1	Body temperature increased; Chills; Erythema; Injection site pruritus; Pain in extremity; Skin warm; Swelling	FLUX~UNKNOWN MANUFACTURER~~6~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~UN~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0334395	12/09/2008	VA	2.0	2	.9	M	11/24/2008	Arm at site of immunization edema, erythema, warmth area 16X11.5 cm, no pain, no pruritus.									U	11/22/2008	11/23/2008	1	CRP; RAST; EGGS	PVT	UNK		None	RAD			1						1	Food allergy; Injection site erythema; Injection site oedema; Injection site warmth; Radioallergosorbent test	FLU3~SANOFI PASTEUR~U2772AA~4~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334396	12/09/2008	TN				U	11/24/2008	Diffuse redness all over with whelps.  Ears red & swollen.  Rash appeared 30 minutes after shots.									Y	11/11/2008	11/11/2008	0	None. We gave BENADRYL & watched.	UNK	UNK		Slight cough				1						1	Auricular swelling; Erythema; Rash; Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14606SAA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2831AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB247AA~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0663X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0334397	12/09/2008	NY	55.0	55		F	10/01/2008	Pain. Decreased mobility left arm. Biceps and deltoid weakness. Limited abduction left arm.				Y					N	09/29/2008	10/01/2008	2	MRI; EMG (tests of exclusion)	OTH	OTH		None	None			1						1	Electromyogram; Injected limb mobility decreased; Muscular weakness; Nuclear magnetic resonance imaging; Pain	FLU3~SANOFI PASTEUR~U2768AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334398	12/09/2008	MO	51.0	51		F	11/26/2008	Pt called in 11-26-08 @ 3:20 pm stated she had a flu shot here yesterday & has a rash on chin & forehead & is itchy.  Instructed her to take BENADRYL as needed & to call Dr of go to ER if condition worsens.  She stated it was probably just her fibromyalgia.										11/25/2008	11/26/2008	1		PUB	PUB		No/Hx of Fibromyalgia	Fibromyalgia			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~SPU2849AC~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334401	12/09/2008	MN		48		F	11/10/2008	Swollen (L) neck lymph nodes - then (L) ear ache and sore throat on (L) only. Worsening until seen by Dr., 11-3-08, @ 6 pm. Dx. Pharyngeal cellulitis. Started Z-pack. Back to Dr., 11-5-08, 11 AM; general malaise, extreme fatigue, continued sore throat, back pain, frequent urination.				Y					Y	10/30/2008	10/30/2008	0	Strep Screen x 2, negative; Liver Ev., negative; CBC (WBC's re); U/A, insignificant	PUB	OTH	ZORCOR; Multivit., held while on Z-pack; Baby ASA	None	None - high cholesterol; Breast CA, 9 mos ago.			1						1	Back pain; Cellulitis pharyngeal; Ear pain; Fatigue; Full blood count normal; Liver function test normal; Lymphadenopathy; Malaise; Oropharyngeal pain; Pollakiuria; Streptococcal identification test negative; Urine analysis normal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA173AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0334402	12/09/2008	GA	14.0	14		F	11/10/2008	Headache, described as severe. Photosensitivity, sore throat, fever vomiting- Used Tylenol, Motrin, Lortab 5mg.									U	11/04/2008	11/04/2008	0	CBC (WNL), CRP=2	PVT	PVT	None	None	None			1						1	C-reactive protein increased; Full blood count; Headache; Oropharyngeal pain; Photosensitivity reaction; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2760AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0571X~1~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0334407	12/09/2008	MA	2.0	2	.0	F	11/13/2008	Developed T- 101, 11/12/08. No hardness and erythema about 50 cent size to injection site.									U	11/03/2008	11/12/2008	9		PVT	PVT	PREVACID; PULMICORT		Bronchospasm; GERD			1						1	Body temperature increased; Injection site erythema	FLU3~SANOFI PASTEUR~42783~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0530X~UNK~UN~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0334408	12/09/2008	TX	38.0	38		M		Service member became lightheaded, clammy and nauseated. Within 10 mins, he was feeling better.									Y	11/22/2008	11/22/2008	0		OTH	OTH	None	None	None			1						1	Cold sweat; Dizziness; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA168AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~UNKNOWN MANUFACTURER~AH8V86408A~UNK~IM~RA~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~UHAVB2518A~UNK~IM~LA~HEP A (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~U2294CA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0334409	12/09/2008	MA	15.0	15		F	11/13/2008	L arm upper deltoid area swollen and tender to touch.  Pain with range of motion.   Instructed parent to watch area for increased signs of infection.   Flu injection administered 10/3/08 Pt seen 11/7/2008 for persistent reaction.									U	10/03/2008	10/03/2008	0	CBC;  ESR;  CRP drawn 11/7/2008	PVT	PUB	ATENOLOL	No	Marfan syndrome;  Scoliosis;  Migrains;  Aortic dilitation			1						1	C-reactive protein; Full blood count; Injected limb mobility decreased; Oedema peripheral; Pain in extremity; Red blood cell sedimentation rate; Tenderness	FLU3~SANOFI PASTEUR~U2766AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334410	12/09/2008	WI	5.0	5		F	11/07/2008	Sl. atypical Gianotti-Crosti; skin reacting on arms/legs/face (min) and feet/minimal on trunk. Clinically confirmed as probably by dermatologist as of yet (will follow). Pt see one month later Giantti Crosti type rash resolved.									U	10/29/2008	11/05/2008	7		PVT	PVT	Amoxicillin since 10/17/2008	Sinusitis - resolving	No allergies; Lymphangioma - shoulder			1						1	Gianotti-Crosti syndrome	FLU3~SANOFI PASTEUR~U2767AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334411	12/09/2008	MN	45.0	45		F	11/20/2008	Severe whole body myalgia beginning 24 hrs after admin. of vaccine. Symptoms continued 5 days later, and required missing 2 1/2 work days.									U	11/14/2008	11/15/2008	1	11/20/08, WBC, wnl; Mono rapid, negative; influenza, 11/21/08,negative; A/B, pending	PVT	PVT	Fentanyl patch; PERCOCET, prn	None	Fibromyalgia; chronic pain; Hx of Rocky Mountain Spotted Fever; encephalitis			1						1	Activities of daily living impaired; Influenza serology negative; Myalgia; White blood cell count	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA155AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0334412	12/09/2008	WI				U		Headache, Chills, fever, R arm Red & warm to the touch x 2day.  11/4/08 date of injection.									Y					UNK	UNK						1						1	Chills; Headache; Injection site erythema; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U2790BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0813X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2998B~UNK~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0334413	12/09/2008	OH	53.0	53		F	11/24/2008	Hives/Pain/Swollen									Y	11/13/2008				PUB	UNK		None				1						1	Pain; Swelling; Urticaria	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~UNK~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0334416	12/09/2008	OH	4.0	4		F	11/12/2008	Urticaria, itching, irregular rash on left thigh not continuous to site, started 11-10-08. First few days hard hot @ site.									U	11/06/2008	11/10/2008	4	None	PVT	PVT						1						1	Injection site induration; Injection site warmth; Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U2849AC~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334421	12/09/2008	CA	59.0	59		M	11/12/2008	Tremors lasting for 2 hrs; occured 12 hrs after dose was given and resolved; did not reoccur also had a sore left deltoid. Patient had no fever during tremors.									Y	10/30/2008	10/30/2008	0		OTH	PVT	Unknown		No allergies			1						1	Injection site pain; Tremor	FLU3~CSL LIMITED~02749111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0334425	12/09/2008	CA	42.0	42		F	11/14/2008	Pt. left without stating she was in pain, but the next day (11/13), about 24 h. later, she said the pain started right after the shot, & she was in alot of pain that night.  She also had some bleeding that soaked thru the bandaid.  On 11/13 at 2 pm she still had pain in upper arm and left side of neck. Now (11/14 at 10 am) she states there is no more discomf, in her arm, but mild discomf. in neck with movement.									Y	11/12/2008	11/12/2008	0	NA	OTH	PVT	None	None	Previous injury to affected arm, but fully recovered.			1						1	Haemorrhage; Neck pain; Pain in extremity	FLU3~SANOFI PASTEUR~2757AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334428	12/09/2008	WA	49.0	49		M	11/24/2008	Conjunctivitis, fever, rigors, cough, wheezing.									Y	11/21/2008	11/21/2008	0	None	PVT	PUB						1						1	Chills; Conjunctivitis; Cough; Pyrexia; Wheezing	FLU3~SANOFI PASTEUR~U2831AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334429	12/09/2008	WA	51.0	0	.3	M	11/23/2008	Pain, left side, lower back, kidney area.									Y	11/20/2008	11/20/2008	0	Unknown	MIL	OTH	LORATIDINE; CLUNAZEPAM	None	Allergies; inactive Hep C			1						1	Back pain; Flank pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0334431	12/09/2008	IA	0.4	0	.4	F	11/11/2008	Non given									U	10/31/2008				OTH	OTH		None				1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~UT2792DA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334432	12/09/2008	AL	94.0	94		M	11/10/2008	Red, swollen area at injection site									Y	10/28/2008	10/28/2008	0		PVT	PVT		None	None			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2757AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334434	12/09/2008	CA		4		U		Redness, mild swelling at injection site.									Y	11/03/2008	11/03/2008	0		PVT	PUB		None	None			1						1	Injection site erythema; Injection site swelling	DTAP~SANOFI PASTEUR~C2935AA~UNK~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2808AA~2~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0805~5~UN~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1944U~2~UN~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1848U~3~UN~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0334435	12/09/2008	KY	4.0	4		M	11/22/2008	Left lateral thigh shows erythema. 6x8 cm area. No induration. No bruising.									Y	11/07/2008	11/09/2008	2		PVT	PVT	SINGULAR; NASONEX; allergy injections		Bees allergist			1						1	Injection site erythema	DTAP~SANOFI PASTEUR~C2955BA~5~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2761AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0836~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0917X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0334436	12/09/2008	MA	11.0	11		F	10/07/2008	Injections (VARIVAX; INFLUENZA) on 11/5/2008.  Am 11/7/2008- redness tenderness warmth at injection site.				Y					U	11/05/2007	11/07/2007	2	None	PVT	PUB		None	Unexplained episode of anaphylaxis			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U2828AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0535X~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0334438	12/09/2008	CA	70.0	70		F	11/12/2008	Severe dizziness (24 hours) headache.  Lightheaded for a few days.									Y	10/29/2008	10/30/2008	1		PVT	UNK		None	Antibiotics			1						1	Dizziness; Headache	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0334439	12/09/2008	TX	55.0	55		M	11/09/2008	Severe shoulder pain at site of injection.  Tender to touch.  Symptoms started suddenly after a week of injection.  Ice application and pain reliever by mouth.  Symptoms better but not resolved.										10/30/2008	11/06/2008	7		OTH	OTH		None				1						1	Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89987~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334440	12/09/2008	NC	62.0	62		F	11/10/2008	Really bad low back pain in pelvic area from Oct 8 - till Nov 3. Took Ibuprofen or Acetimine for pain. Hot water bottle. Use my cane. Woke up and could hardly walk.									Y	10/07/2008	10/08/2008	1	None	OTH	PUB	None	None	Degenerative bone disease			1						1	Back pain; Gait disturbance	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88906~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334441	12/09/2008	MD	52.0	52		U		Fatigue, fever, nausea, I am diabetic, my sugar readings ran extremely low.  My appetite was at one point extremely low and I could not keep the little food I did eat down.  I was vomiting, my stomach hurts.									N	10/29/2008	10/31/2008	2		OTH	PUB						1						1	Abdominal pain upper; Blood glucose decreased; Condition aggravated; Decreased appetite; Fatigue; Nausea; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0334442	12/09/2008	FL	12.0	12		U		Localized erythematous plaque 6cms circle on left deltoid noted @ 8:30A 11/12/2008									U	11/10/2008	11/12/2008	2	None	OTH	OTH	None	No				1						1	Rash erythematous; Skin plaque	FLU3~SANOFI PASTEUR~U2771AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334443	12/09/2008	CT	63.0	63		F	11/11/2008	Within 1 hour felt she had a lump in her throat and had diff. swallowing.  This was gone the next day.  Her eyes also began to itch, whites blood shot, rims red.  Crusty and very itchy the next day.  Saw eye MD 11/6 who thought she may be sensitive to THIMEROSOL (no previous allergy to this) By the 3rd day symptom free.									Y	11/04/2008	11/04/2008	0	None	PUB	PVT	SERAVENT, ALBUTEROL, CINGULAR inhalers	None	Mild seasonal allergies;  Bronchial asthma			1						1	Dysphagia; Eye discharge; Eye pruritus; Ocular hyperaemia; Scab; Sensation of foreign body	FLU3~SANOFI PASTEUR~U2751AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334450	12/09/2008	DC	63.0	63		M	11/20/2008	Throat tightened up- chest congestion, general body aches- began 2 hrs after vaccines.  Went to ER- after 3 hrs wait, went home.  Took BENADRYL- improved.				Y					Y	11/06/2008	11/06/2008	0		PVT	PVT	None	No	Had taken flu vaccines before with no problem.			1						1	Pain; Respiratory tract congestion; Throat tightness	DTAP~SANOFI PASTEUR~UF452CA~UNK~UN~UN~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2811AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334451	12/09/2008	CA	42.0	42		F	11/17/2008	Blood shot, swollen eyes- painful swollen.									Y	11/04/2008	11/04/2008	0		MIL	UNK						1						1	Eye pain; Eye swelling; Haemorrhage	FLU3~SANOFI PASTEUR~U2767AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334452	12/09/2008	AZ	61.0	61		F	11/18/2008	11-7-08 Got the flu shot approximately 6:20pm.  11-8-08 approximately 8pm got fever and chills.  11-9-08 - Fever, chills, couldn't get out of bed-no pain- just very tired, needed to lay down.  Got rash from neck down to past waist and down arms.  11-12-08 went to my doctor with rash and fever and was told I had an allergic reaction to the flu shot.  I was given PREDNISONE and the rash went away in 3 days.				Y					Y	11/07/2008	11/08/2008	1	Doctor physical exam	OTH	OTH	MINOCYCLINE;  BENADRYL; Baby aspirin; PREMPRO	None	None			1						1	Activities of daily living impaired; Chills; Fatigue; Hypersensitivity; Pyrexia; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89994~7+~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0334453	12/09/2008	CA	50.0	50		F	11/18/2008	Eyes swollen, itchy and red.									Y	11/13/2008	11/13/2008	0	None	PVT	UNK						1						1	Eye pruritus; Eye swelling; Ocular hyperaemia	FLU3~SANOFI PASTEUR~U2759AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334456	12/09/2008	MA	56.0	56		F	11/20/2008	Experienced headache, fever, chills and anorexia x 6 days. Was instructed by her primary care MD to notify me as a vaccine adverse event.									Y	11/13/2008	11/14/2008	1		OTH	PVT	None		Allergy to Pen			1						1	Anorexia; Chills; Headache; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89126~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334458	12/09/2008	CA	4.0	4		F	11/13/2008	Local erythema and induration, 60 X 75 mm (R) deltoid.									Y	11/12/2008	11/13/2008	1	No	PVT	PVT	TYLENOL	No	None			1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U2766AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334459	12/09/2008	OH	74.0	74		F	11/24/2008	3 to 4 days after shot.  Chills, fever, neck aches, sore throat, nausea, diarrhea.  11-29- still lingering with MR.									N	11/15/2008	11/18/2008	3		OTH	OTH	Blood pressure medicine	None-Healthy	None	dizzy~Influenza (Seasonal) (no brand name)~1~71.00~In Patient		1						1	Chills; Diarrhoea; Nausea; Neck pain; Oropharyngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U2751AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334460	12/09/2008	NM	58.0	58		F	11/20/2008	Body aches, stiff neck for two days after shot date. Rash started three days after shot date, was located four inches below shot site.									Y	10/28/2008	10/30/2008	2		PUB	UNK						1						1	Musculoskeletal stiffness; Pain; Rash	FLU3~SANOFI PASTEUR~U2806AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2766AA~UNK~UN~UN~TDAP (ADACEL)~1	USA		Influenza
0334462	12/09/2008	VA	84.0	84		F	11/25/2008	Redness at injection site 4 days, swelling of hands after a few weeks, woke up to her chest pounding, a few weeks after injection.				Y					Y	10/09/2008	10/10/2008	1		OTH	OTH		No				1						1	Injection site erythema; Oedema peripheral; Palpitations	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0964U~2~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0334463	12/09/2008	CO	6.0	6		M	11/24/2008	Local site reaction - no treatment.									Y	11/21/2008	11/22/2008	1	None	PVT	PVT	None	None	None			1						1	Local reaction	FLU3~SANOFI PASTEUR~U2761AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334464	12/09/2008	CO	15.0	15		F	11/18/2008	Fever, body aches, inflammation at site of injection. Pt went to emergency room & tx'd with Rocephin and Keflex.				Y					Y	11/14/2008	11/15/2008	1		PVT	PVT		None				1						1	Injection site inflammation; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2797AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0070X~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2622AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B024AA~1~IM~RA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~0991X~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0334465	12/09/2008	OH	5.0	5		U		Lt arm swelling from shoulder down past elbow, itching, blotchy redness. Benadryl 1 1/2-2 tsp every 6 hours to give PO.									U	11/06/2008	11/07/2008	1	None	PVT	PVT	None	None	None			1						1	Oedema peripheral; Pruritus; Rash macular	FLU3~SANOFI PASTEUR~U2849AC~5~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334467	12/09/2008	CA	9.0	9		M	11/14/2008	Large red swelling of arm/upper arm 12x10 cm in diameter at site of injection.									N	11/12/2008				PVT	PVT		None	None			1						1	Erythema; Injection site swelling; Oedema peripheral	FLU3~SANOFI PASTEUR~U2766AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334468	12/09/2008	NC	0.8	0	.8	F	11/25/2008	Flu vaccine administered @ 3:40 pm on 11-18-08.  Mom reported 101.5 AX fever on 11-19-08.  Child in office on 11/20/08 @ 3:45 pm with 106.4 (R) fever.  ROCEPHIN 500 mg IM administered.  CXR, CBC. UA all WNL on 11-20-08.									Y	11/18/2008	11/19/2008	1	CXR; CBC; UA - WNL on 11-20-08	PVT	PVT		None	None	Fever~Influenza (Seasonal) (no brand name)~1~0.80~In Patient		1						1	Chest X-ray normal; Full blood count normal; Pyrexia; Urine analysis normal	FLU3~SANOFI PASTEUR~U2742AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334469	12/09/2008	PA	64.0	64		U	11/15/2008	Right arm swelled from elbow to shoulder and was red and warm. Hospital gave me intravenous with BENADRYL, PEPCID and SOLUMEDROL (steroid), ZYRTEC (5 daysx1 day).				Y					Y	10/30/2008	10/30/2008	0		PUB	UNK	BUDEPRION SR; AMLODIPINE; BENAZEPRIL; FEXOFENADINE HCL; PRANDIN; ZETIA; METOFORMIN HCL; HYDROCHLOROZIDE	Right arm swelled, red; Shot(flu) had one left arm				1						1	Erythema; Oedema peripheral; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~1~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0334470	12/09/2008	UT	7.0	7		F	11/17/2008	Fainted after injection - causing a concussion - vomiting - wanting to sleep.				Y					Y	11/17/2008	11/17/2008	0		PVT	PUB	None	None	Resolving pneumonia			1						1	Concussion; Somnolence; Syncope; Vomiting	FLU3~SANOFI PASTEUR~U2829AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334471	12/09/2008	MI	2.0	2	.7	F	11/13/2008	Flu vaccine received 11-11-08 0.25 Sanofi Past #UT27996A. Broke out in hives later that day, called 9-10P advised to go to ER.				Y					Y	11/11/2008	11/11/2008	0		PVT	PVT	None	None	None			1						1	Urticaria	FLU3~SANOFI PASTEUR~UT27996A~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334472	12/09/2008	DE	3.0	3		M	11/17/2008	Vaccine for flu administered 11/12/08 AM. That night his mother noted a tiny area of frontal hair loss. Continues to fall out now = 22mm X 10 mm bald (alopecia) patch. Treatment = refer to derm, Beclomethasone foam.									U	11/12/2008	11/12/2008	0	None; Refer to Dermatologist.	PVT	PVT	Fluticasone Cream prn	None	None			1						1	Alopecia	FLU3~SANOFI PASTEUR~U2795DA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334474	12/09/2008	OR	5.0	5		M	11/17/2008	Bad hives on body.... still has them today! Got them after he had the shot! No recovery so far.									N	11/14/2008	11/14/2008	0		PVT	UNK	None	No	No			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2853AB~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334475	12/09/2008	OR	3.0	3		M	11/18/2008	Flu imm. given on 10-21-08 with FLUVIRIN. Age group to be 4+ years. Child was only 3 years when given. No apparent problems									U	10/21/2008				PVT	PVT			None			1						1	Inappropriate schedule of drug administration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881171P~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334476	12/09/2008	AZ	0.6	0	.6	M	11/15/2008	Received flu vaccine on 11-13-08 and now has bullous @ site - non tender, or red, clear fluid - C and S just for precaution - no result yet.									Y	11/13/2008	11/14/2008	1	C and S of bullous drainage - no results yet	PVT	PUB	None	None	None			1						1	Culture; Injection site vesicles	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B06AA~3~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2785DA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334477	12/09/2008	WI	2.0	2	.6	F	11/14/2008	Rash on left thigh only (fine, red, sl). Fluzone given left thigh, 7 days prior. Child was not ill.				Y					Y	11/06/2008			None	PVT	PVT	Fluoride	No	None	~Influenza (Seasonal) (Fluzone)~UN~2.00~Patient		1						1	Injection site erythema; Injection site rash	FLU3~SANOFI PASTEUR~U2761AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334479	12/09/2008	DE	17.0	17		M	11/14/2008	Started 8pm on 11-13-08, vomiting all night, last time was 2pm 11-14-08. Flu symptoms, low grade fever, diarrhea. Not a flu shot, sprayed up nose, live vaccine.									Y	11/11/2008	11/13/2008	2		PVT	OTH						1						1	Diarrhoea; Influenza; Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500545P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0334480	12/09/2008	CT	56.0	56		F	11/16/2008	10/28 Upper arm got very hot & red - swelled then was very sore could not lay on arm or move it.  In the a.m. upon waking- could not raise hand.  Called doc. office was put on CEPHALEXIN 500 mg.  (10/29).  On 10/30 lower part of arm and hand swelled, very hot and red.  Saw Dr. was put on CLARITIN & BENADRYL & continue taking CEPHALEXIN.  Applied ice.									U	10/28/2008	10/28/2008	0		PVT	UNK	FOSAMAXD; vitamins & SERTRALINE 100 mg	No	Osteoporosis			1						1	Erythema; Injected limb mobility decreased; Oedema peripheral; Skin warm; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA154AA~7+~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0868X~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0334481	12/09/2008	RI	7.0	7		F	11/13/2008	Generalized tonic clonic seizure, 6-7hrs after receiving vaccine. Afebrile.				Y					Y	11/12/2008	11/12/2008	0	Head CT & bloodwork normal	PVT	PUB						1						1	Blood test normal; Computerised tomogram normal; Grand mal convulsion	FLUN3~MEDIMMUNE VACCINES, INC.~500555P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0334484	12/09/2008	FL	18.0	18		F	11/10/2008	I heard patient cough about 4 times within 5 min. I asked her if she had a little cold or what was going on with her cough. She asked me if it was normal to be dizzy and short of breath. I went to check her - she was pale, weak pulse, and sweaty. The cough became more frequent. We called EMS - gave her 50 mg BENADRYL. She became nauseated and then improved in 10 minutes.									Y	11/07/2008	11/07/2008	0	All vital signs normal for EMS (pulse ox = 100%, BP/Pulse normal). They did not take her to ER - determined not allergic Rxn, possible vasovagal.	OTH	PVT	None	None	None			1						1	Blood pressure normal; Cough; Dizziness; Dyspnoea; Heart rate normal; Hyperhidrosis; Nausea; Oxygen saturation normal; Pallor; Pulse pressure decreased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA157AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0334485	12/09/2008	NY	72.0	72		F	11/14/2008	Red, burning, itching rash over most of body- injection at ER. Plus tablets 6 days methylprednisolone 4 mg; Hydroxyzine 25 mg fever for 7 days; rash for 12 days. followed by: swelling in joints and pain in joints 14 days.  - Relief with Ibuprofen 600 mg x 3				Y					Y	10/06/2008	10/15/2008	9		PVT	OTH	SYNTHROID 88 mcg; COZAAR 50 mg		Thyroid gland removed; High blood pressure			1						1	Arthralgia; Burning sensation; Joint swelling; Pyrexia; Rash erythematous; Rash pruritic	FLUX~UNKNOWN MANUFACTURER~~7+~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0334486	12/09/2008	TX	51.0	51		M	11/12/2008	Flu shot 11/5/08. Arm sore next day, low grade fever, tiredness and cough. 11/8/08, rash to chest, abdomen, groin, hands and lower legs. BENADRYL on 11/10 and 11/11. Getting better with rash on 11/12. Still had cough and residual rash effects - itching and redness.									Y	11/05/2008	11/06/2008	1	None	UNK	UNK	Multivitamin	None	Hay fever allergies			1						1	Cough; Erythema; Fatigue; Pain in extremity; Pruritus; Pyrexia; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334487	12/09/2008	KY	33.0	33		F	11/14/2008	Within minutes of receiving the vaccine, her face flushed-she said her throat tightened, and she felt 'tingly' all over.  Her throat returned to normal within minutes but the tingling stayed.  I called 911 as soon as she complained.  EMS took her to the ER.  She was conscious the entire time.				Y					U	11/14/2008	11/14/2008	0		OTH	UNK		None				1						1	Flushing; Paraesthesia; Throat tightness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0551X~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0334488	12/09/2008	MN	65.0	65		F	11/06/2008	Patient (right) arm was sore and began to become red & swollen over a few days. Patient placed on Keflex by her doctor for skin infection.				Y					Y	10/29/2008	10/29/2008	0	None	OTH	PVT	Citalopram; Cozaar; Simvastatin; Synthroid	None	None			1						1	Erythema; Oedema peripheral; Pain in extremity; Skin infection	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~09644~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0334489	12/09/2008	MS	21.0	21		F	11/14/2008	11-12-08 DX with pharyngitis, strep test negative.  Reported enlarged lymph nodes, extreme fatigue, stiff neck.  Symptoms onset on or around 11-10-08.  Improved energy by 11-13-08.  Return to on 11/14/08.  On 10-31-08 c/o nausea 20 minutes after shot, went away.									Y	10/31/2008	11/10/2008	10	Negative strep test 11/12/08	PUB	OTH	None	No	None			1						1	Fatigue; Lymphadenopathy; Musculoskeletal stiffness; Nausea; Pharyngitis; Streptococcal identification test negative	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA173AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0334490	12/09/2008	CA	85.0	85		F	11/12/2008	In 2 hours-runny nose-sneezing-chest congestion-dry mouth-chills-fever-massive headache-sinus ache-tooth ache- heavy head- miserable! Some less miserable by 10:00 PM. Next day- weak-asthma-phlegm-cough.									Y	10/16/2008	10/16/2008	0	None	OTH	OTH	None	None	Heart valve weak and heart murmur			1						1	Asthenia; Asthma; Chills; Cough; Dry mouth; Feeling abnormal; Headache; Increased upper airway secretion; Pulmonary congestion; Pyrexia; Rhinorrhoea; Sinus headache; Sneezing; Toothache	FLUX~UNKNOWN MANUFACTURER~~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0334492	12/09/2008	CA	30.0	30		F	11/01/2008	Pt felt dizzy, room went black, felt hot and cold. Felt as though she was going to faint. Vital signs 120/76, P69, SPO2 99%.									Y	11/01/2008	11/01/2008	0		PVT	UNK						1						1	Dizziness; Feeling of body temperature change; Heart rate normal; Oxygen saturation normal	FLU3~SANOFI PASTEUR~U2772AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334494	12/09/2008	RI	57.0	57		F	11/14/2008	Severe pain reported by patient in area of injection site. Small surface bruising. Patient required medical attention. Sent to Urgent Care facility for xray. 4-5 days for complete recovery.				Y					Y	11/04/2008	11/05/2008	1	xray indicated hematoma at right deltoid muscle	PUB	PUB		None	None			1						1	Injection site haematoma; Injection site pain; X-ray abnormal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881135P~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0334496	12/09/2008	IL	73.0	73		M	11/09/2008	Approx 15 min after flu shot given pt returned to clinic. He was flushed B/P 158/08 No SOB or chest pain. Sent to ER.				Y					U	11/09/2008	11/09/2008	0		OTH	UNK	CELEBREX					1						1	Flushing	FLU3~SANOFI PASTEUR~42806AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334497	12/09/2008	MN	1.3	1	.3	M	11/11/2008	Temp to 104, lethargy alternating with irritability, dehydration. Seen in office initially--looked toxic, tachycardic with pulse of 169 so sent to ER for evaluation. Received IVF, antipyretics.  Labs showed mild acidosis. (HCO3 of 18) otherwise normal. Also with rash (L) thigh.				Y					Y	11/05/2008	11/05/2008	0	WBC 3.1.  62% neutrophils; Hgb, 11.4; CO2 - 18; nl electrolytes and renal function	PVT	PVT	None	None	None			1						1	Acidosis; Blood bicarbonate decreased; Blood electrolytes normal; Body temperature increased; Carbon dioxide decreased; Dehydration; Haemoglobin normal; Irritability; Lethargy; Neutrophil percentage; Rash; Renal function test normal; Tachycardia; White blood cell count decreased	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC146085BA~1~UN~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2782BA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C69205B~4~UN~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0334501	12/09/2008	CO	4.0	4		F	11/19/2008	Onset of peripheral edema, 11/6/08. Progression to bruising rash, diagnosed Henoch Schonlein Purpura on 11/7/2008. Urinalysis showed hematuria consistent with HSP.				Y					Y	10/18/2008	11/06/2008	19	WBC, 13,000; U/A, 4-10 RBC; ESR 5; BUN 24	PVT	PVT		None	Absent right kidney			1						1	Blood urea increased; Contusion; Haematuria; Henoch-Schonlein purpura; Oedema peripheral; Rash; Red blood cell sedimentation rate normal; Red blood cells urine positive; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~881291P~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0334504	12/09/2008	HI	8.0	8		F	11/20/2008	Flu clinic started at 8:15 am. Patient received LAIV. At 11:00 am patient was in health room with redness and mild swelling around right eye, dime size erythema to both arms (4) and 1 on right neck with itching. Denies allergies.									Y	11/20/2008	11/20/2008	0	None	OTH	PUB		None				1						1	Erythema; Eye swelling; Ocular hyperaemia; Pruritus	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0334505	12/09/2008	MN	66.0	66		F	11/14/2008	Experienced dizziness and nausea the night of the flu shots next morning. Decided to eat lunch then Friday (10/31) and felt better for approx. 1 hr. Then left work vomited and was very tired. Slept rest of afternoon and night. Tired Saturday but no more vomiting or dizziness.									Y	10/30/2008	10/30/2008	0		PUB	PVT						1						1	Activities of daily living impaired; Dizziness; Fatigue; Hypersomnia; Nausea; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA380CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0334507	12/09/2008	MN	5.0			M	11/21/2008	A reaction that almost appeared to be vagal like. He became light headed, got pale and felt like he was going to throw up. Pulse 88.									Y				None	PVT	OTH	None	Resolved URI	Amoxicillin			1						1	Dizziness; Heart rate normal; Nausea; Pallor	FLUN3~MEDIMMUNE VACCINES, INC.~500551P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0334508	12/09/2008	CT	16.0	16		F	11/20/2008	Painful cystic/lump to area around injections site. No response to KEFLEX. Had sx started 3 wks after injection - ??									U	10/20/2008	11/08/2008	19	Sonogram of area, hypoechoic mass	PVT	UNK	None	None	None			1						1	Injection site mass; Injection site pain; Ultrasound scan abnormal	FLU3~SANOFI PASTEUR~U2754AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0548X~3~IM~RA~HPV (GARDASIL)~1	USA		Influenza
0334509	12/09/2008	AL	32.0	32		M		Bloody nose regularly, loss of taste, and heightened allergy symptoms.									N	10/07/2008	10/21/2008	14	None	MIL	MIL	None	No	None			1						1	Ageusia; Epistaxis; Hypersensitivity	FLUN3~MEDIMMUNE VACCINES, INC.~500547P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0334510	12/09/2008	PA	12.0	12		F	11/21/2008	60 hours after FLUMIST administration, pt developed generalized hives all over face, pruritus of face, and headache. BENADRYL administered - helped.									Y	11/17/2008	11/20/2008	3	None	PVT	PVT	ZYRTEC, prn	None	Allergic Rhinitis -  mild			1						1	Headache; Pruritus; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500583P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0334511	12/09/2008	VA	28.0	28		F	11/21/2008	11/18/08, patient called and said scalp was itchy that night after shot. Next morning noticed bumps on neck and scalp, and hands were itchy and red. Rash went away then reappeared. Next day called and said muscles felt achy. Dr at one time told her she was allergic to penicillin or eggs, but she eats eggs and does not have a reaction.									U	11/14/2008	11/14/2008	0		OTH	UNK			Patient stated allergic to penicillin			1						1	Myalgia; Rash erythematous; Rash pruritic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89994~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334513	12/09/2008		40.0	40		F		Patient complained of itching at injection site. 12 min after injection. No SOB, chest tightness or rash. Resolved with treatment.									Y	11/03/2008	11/03/2008	0		MIL	MIL	MTV; B-6; Folic acid; Zyrtec; Singulair; Aldomet; Nexium		Aero Allergies and hypertension	Itching~Influenza (Seasonal) (no brand name)~8~36.00~Patient|Itching~Influenza (Seasonal) (no brand name)~5~33.00~Patient		1						1	Injection site pruritus	FLU3~SANOFI PASTEUR~U2833AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334514	12/09/2008	CA	62.0	62		F	11/20/2008	Hives no treatment, mild duration: 3 weeks so far.									U	10/28/2008	10/29/2008	1		PVT	UNK	None	No	No			1						1	Induration; Urticaria	FLUX~UNKNOWN MANUFACTURER~UNK~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0334516	12/09/2008	MI	39.0	39		F	11/17/2008	Pt has an area of cellulitis to medial aspect of left upper arm- 8 cm X 16 cm. with axillary adenopathy.  (+) fevers (101.6) and pain.				Y					Y	11/14/2008	11/15/2008	1		PVT	PVT		None	Asthma, hx Ovarian cancer.			1						1	Injection site cellulitis; Lymphadenopathy; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2739AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1381U~1~SC~LA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2998BA~1~IM~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0334517	12/09/2008	WI	39.0	39		F	10/23/2008	10-23-08 Employee called center to report she had a swollen left arm which she had received a flu shot in on 10/20/08.  Employee stated left arm was red & swollen and she was unable to lift arm.  Also neck was sore.  Employee advised to seek medical attention.				Y					Y	10/20/2008	10/20/2008	0		OTH	OTH	None	None	Multiple Sclerosis (MS)			1						1	Erythema; Injected limb mobility decreased; Neck pain; Oedema peripheral	FLU3~CSL LIMITED~03549111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0334518	12/09/2008	OH	52.0	52		F	11/08/2008	Pt initially stated she started with cough, congestion and nausea a few days after injection. Process has furthered to what she and her physician believe is shingles. Pt now has painful lesions on body.				Y					U	10/17/2008	10/25/2008	8		OTH	PVT	Lorazepam; Desoximetasone cr. 0.05%	None stated				1						1	Cough; Herpes zoster; Nausea; Pain; Respiratory tract congestion; Skin lesion	FLU3~SANOFI PASTEUR~88129~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334519	12/09/2008	NY	76.0	76		M	11/17/2008	Itchy swollen/ firm and tender area developed around shot site 2 weeks after shot-slowly resolving but still visibly swollen.									N	10/15/2008	10/30/2008	15	None	PVT	PVT	HCTZ; LISINOPRIL; AMLODIPINE; NEXIUM; CELEBREX; MIRALAX	None	None; HTN, Arthritis, GERD			1						1	Injection site induration; Injection site pain; Injection site pruritus; Injection site swelling	FLU3~SANOFI PASTEUR~U2809AA~7+~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334521	12/09/2008	MN	51.0	51		M	11/17/2008	1 1/2 weeks ago had flu shot, when shot given-no pain.  Within a few hours swelled up and sore.  Still sore - hardened size of 1 1/2 circle. 1:50 p.m.									N	11/07/2008	11/07/2008	0	None	OTH	PVT	None, Centrum MTV	None	None	1X Sick post shot-flu like symptoms then pneumonia 5-7 yrs ago.~Influenza (Seasonal) (no brand name)~UN~45.00~In Patient		1						1	Induration; Pain; Swelling	FLU3~SANOFI PASTEUR~U2754AA~7+~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334522	12/09/2008	OK	0.85	0	.9	M	11/14/2008	Fever and seizure approx 12hrs after immunizations.				Y					Y	11/06/2008	11/06/2008	0	Patient was positive for parainfluenza virus	PUB	PUB	None	Not symptomatic at the time of vaccination - but was (+) for virus	None			1						1	Convulsion; Parainfluenzae virus infection; Pyrexia	DTAPIPVHIB~SANOFI PASTEUR~C3201AA~1~UN~UN~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~UT2794BA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB618AA~2~UN~UN~HEP B (ENGERIX-B)~1|PNC~PFIZER\WYETH~C22283~1~UN~UN~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0334523	12/09/2008	IL	2.0	2	.1	M	11/17/2008	Hives around injection site, left leg. No fever, no wheezing. Tender to touch.									Y	10/29/2008	10/29/2008	0		PUB	PUB		None	Outdoor allergies			1						1	Injection site pain; Injection site urticaria	FLU3~SANOFI PASTEUR~UT2787DA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334525	12/09/2008	ID	54.0	54		M	11/18/2008	Severe generalized pruritic urticarial reaction with periorbital edema. Just swelling & pain.				Y					Y	10/31/2008	10/31/2008	0		OTH	PVT	LISINOPRIL, 10mg	None	None			1						1	Arthralgia; Joint swelling; Periorbital oedema; Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~FLLA19288~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0334527	12/09/2008	CA	0.8	0	.8	M	11/19/2008	Localized reaction to left thigh after flu vaccine was given. Red and swollen. 1/2 tsp of BENADRYL was given and had patient wait in our office for 20 mins.									Y	11/17/2008	11/17/2008	0	None	PVT	PVT	BENADRYL; KENOLOG cream	None	None			1						1	Injection site erythema; Injection site swelling; Local reaction	FLU3~SANOFI PASTEUR~UT2783EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0725X~3~IM~LL~HEP B (FOREIGN)~1	USA		Influenza
0334529	12/09/2008	OH	42.0	42		F	11/05/2008	Patient had swelling, increased tenderness, increased warmth in left arm, that started at injection site and extended to under the arm and almost to elbow. Started within 24 hours after PNEUMOVAX injection.									Y	11/03/2008	11/04/2008	1	None needed	PVT	PVT	ALBUTEROL; ADVAIR; ZEGERID; Valium; VICODIN; COMBIVENT; FLONASE; PHENERGAN; MOBIC		COPD; NKDA			1						1	Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2811AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0868X~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0334531	12/09/2008	CO	0.76	0	.8	M	11/07/2008	Fever 6 days after immunization (104.5) severe neutropenia diagnosed 9 days after immunization (10/27/08) mildly elevated LFT (10/27/08).				Y					U	10/18/2008	10/24/2008	6	WBC 9.2 (2% neutrophil, 2% band) ANC-0.4, AST-116	PVT	PVT	None	None	None			1						1	Aspartate aminotransferase increased; Liver function test abnormal; Neutropenia; Neutrophil count decreased; Neutrophil percentage decreased; Pyrexia	FLU3~SANOFI PASTEUR~UT2782CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334532	12/09/2008	MA	10.0	9		F	11/15/2008	Fainted, hit head - call to 911 - out for approx. 10 sec. Was limp - came to good color. Alert x 3, pulse 80. Sat on floor - applied ice pack to forehead - small bump. No bleeding. Paramedics came checked her out - refused to go to hospital - Mom took home.									Y	11/15/2008	11/15/2008	0	F/U call to mom @ 3:30. Pt. fine, eating/drinking. No headache/dizziness.	PUB	PUB			None			1						1	Head injury; Hypotonia; Syncope	FLU3~SANOFI PASTEUR~U2831AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334533	12/09/2008	LA	13.0	13		F	11/20/2008	Hives over entire body, eye swollen, no trouble breathing.									Y	11/18/2008	11/20/2008	2		PVT	PVT	CLARITIN; FLOVENT; EXTENDRYL	Pharyngitis; viral syndrome	Allergies; asthma			1						1	Eye swelling; Urticaria	FLU3~SANOFI PASTEUR~U2806AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334534	12/09/2008	ND	73.0	73		M	11/20/2008	830 Flu and shingles, 840 felt a little itchy, 1030 feeling generalized itchiness and flush took Benadryl, 11AM nauseated and throat feeling funny. 1145 felt terrible, wife states he passed out- patient says he was just too sick to speak. 1pm seen in the clinic.				Y					Y	11/10/2008	11/10/2008	0	See clinic notes and laboratory reports 11/10/08 and 11/14/08	PUB	PVT	Triamterene; Celebrex; ASA; Flomax; Finasteride	No	No known allergies			1						1	Flushing; Loss of consciousness; Malaise; Nausea; Pruritus generalised; Throat irritation	FLU3~SANOFI PASTEUR~U2772AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~1214X~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0334535	12/09/2008	NY	20.0	20		M	11/07/2008	Hives with itching.				Y					Y	11/06/2008	11/06/2008	0	CBC	MIL	OTH	None		Pancreatitis, PCN, Patient consulted with physician before getting shot.			1						1	Full blood count; Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197A~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0334536	12/09/2008	KY	4.0	4		M	11/19/2008	Patient had a reaction on Right thigh measuring 4 1/4cm down and 5 1/2cm wide.									Y	11/17/2008	11/18/2008	1		PVT	PUB	CLINDAMYCIN; ALBUTEROL; FLOVENT, INH	None	Latex allergy			1						1	Injection site reaction; Local reaction	DTAP~SANOFI PASTEUR~C2965AA~5~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2785AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0492~4~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0985X~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1223X~2~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0334540	12/09/2008	AL	77.0	77		M	11/18/2008	Redness, swelling, and tenderness around injection site. (L) arm.									Y	10/22/2008	10/23/2008	1		PVT	PVT	Amiodarone Hydrochloride; Coumadin; Glimepiride; Imdur; Levothroid; Nexium; Norvasc; Plavix; Prinzide; Toprol	None	None			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2803AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1384U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0334541	12/09/2008	MT	48.0	48		F	11/18/2008	Within 30min. after injection swelling, redness, hot down arm. In 12hrs - Shooting pain to neck and numbness in (2) fingers. Took ibuprofen/Tylenol. Diaphoretic all day. Presented to ER 11/5 am. At 0300 11/5 she was completely diaphoretic. Chest tight and wheezing. Albuterol tx, IV steroids, po prednisone for 3 days.				Y					Y	11/03/2008	11/03/2008	0	CBC at time of event - WNL ; EKG WNL; BP WNL; O2 SAT WNL after HHN TX	PVT	PVT	Weekly Allergy; Zyrtec; Cymbicort; Lexapro; Singulair; Albuterol; Klonopin	None	Allergy to airborne pathogens; Sjorgren's Syndrome; Hashimoto's autoimmune thyroiditis; Asthma			1						1	Blood pressure; Chest discomfort; Electrocardiogram normal; Erythema; Full blood count; Hyperhidrosis; Hypoaesthesia; Neck pain; Oedema peripheral; Oxygen saturation normal; Pain; Skin warm; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA173AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|TDAP~SANOFI PASTEUR~C2767AA~1~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0334543	12/09/2008	MD	45.0	45		U		Patient complaining of general malaise. Afebrile, local tenderness left deltoid at injection site. PaleHalo around site( no heat or swelling).									U	11/19/2008	11/20/2008	1		OTH	OTH		None	None			1						1	Injection site discolouration; Injection site pain; Malaise	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0334544	12/09/2008	DE	52.0	52		U		Pt vaccinated on Tuesday, she started having a burning sensation in chest, hoarse voice and wheezing on Wed night. She is an Asthma pt. She has not used her inhaler for a while. She has not contacted her Dr yet. She was at work today. (Friday 11/14/08).									U	11/11/2008	11/12/2008	1		OTH	UNK		No	Asthma			1						1	Burning sensation; Dysphonia; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334545	12/09/2008	AZ	72.0	72		M	11/17/2008	Fever chills Lower Back muscles aches									Y	10/22/2008				PVT	UNK						1						1	Back pain; Chills; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0334547	12/09/2008	UT	51.0	51		F		3 hrs. after flu shot, felt like lump in throat. Hard time breathing, S. O. B. Coughing.				Y					Y	11/19/2008	11/19/2008	0		PUB	OTH		None	None			1						1	Cough; Dyspnoea; Sensation of foreign body	FLU3~SANOFI PASTEUR~U2804AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334548	12/09/2008	AZ	29.0	29		F	11/12/2008	FLULAVAL 0.5 that is given (Lt) deltoid. Noted redness swelling at site of injection and  swelling of hand 11/11/08. 11/12/08 now no swelling of hand, however noted small area of redness at injection site stated put cold compress at site with relief.									Y	11/10/2008	11/11/2008	1		PUB	OTH		None	None			1						1	Injection site erythema; Injection site swelling; Oedema peripheral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA181AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0334550	12/09/2008	NJ	5.0	5		F	11/21/2008	Mother noted 11/20/08, at approx. 3:00 p.m, Rt arm of child appeared bright red with bumpy type rash, approx. 2 width x 4 length in area below injection site. Child stated it was itchy all day at school.									N	11/18/2008	11/20/2008	2		PUB	PUB						1						1	Injection site erythema; Injection site pruritus; Injection site rash	DTAP~SANOFI PASTEUR~C2607AA~5~UN~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2791DA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0266X~2~UN~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0334553	12/09/2008	SC	49.0	49		M	11/21/2008	S/S reported on 11/20/08 to nurse practitioner - reported that evening of 11/13/08, his arm felt numb tingling down (L) arm. Afebrile. Some redness noted @ injection site and he put alcohol on it and went away. Later, he said (L) leg was crampy and numb off/on several days. No loss of strength or motor movement of (L) side. Took Goody's off/on with some relief. Only slight tingling feeling of (L) arm on 11/21/08.									Y	11/13/2008	11/13/2008	0	None	OTH	PVT	None	None	No Known allergies or birth defects; Med Dx GERD (not on meds, diet manipulation)			1						1	Hypoaesthesia; Injection site erythema; Muscle spasms; Paraesthesia	FLU3~CSL LIMITED~01349111A~1~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0334554	12/09/2008	MA	35.0	35		F	11/21/2008	Developed pain initially hours after injection, then developed erythema and swelling to medial aspect of left arm below deltoid site to just above the elbow. Patient did have duragesic patch in place, due to be changed today.				Y					U	11/19/2008	11/19/2008	0		PVT	OTH	See attached		See attached			1						1	Erythema; Oedema peripheral; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA388BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1021X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0334555	12/09/2008	TX	1.3	1	.3	M	11/22/2008	Unarousable in the morning. Mom called 911. Lethargic. Taken to ED. Given IV fluids. arousable and back to normal self by 11 AM on 11/13. This was a Hyporesponsive episode likely due to DTaP.				Y					Y	11/11/2008	11/13/2008	2	Head  CT	PVT	PVT		None	Acute croup 02/08			1						1	Computerised tomogram; Depressed level of consciousness; Hypotonic-hyporesponsive episode; Lethargy; Vaccination complication	DTAP~SANOFI PASTEUR~C2955BA~5~UN~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2769AA~3~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334556	12/09/2008	WI	37.0	37		F	11/24/2008	Received vaccine at school flu clinic. Within 2 hours begin coughing, felt like chest full. Bronchitis, coughed, increased phlegm, face, cheeks and jaw felt weird. Lump in throat. Fever, chills, tingling and non stop headaches. Went to clinic to receive shot of BENADRYL and prescription of ZANTAC/BENADRYL.				Y					Y	11/04/2008	11/04/2008	0	Clinical exam per physician	OTH	UNK			None			1						1	Bronchitis; Chest discomfort; Chills; Cough; Headache; Increased upper airway secretion; Paraesthesia; Pyrexia; Sensation of foreign body	FLU3~SANOFI PASTEUR~U2810AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334557	12/09/2008	IL	61.0	61		F	11/17/2008	ER @ 10:30, 11/14 - IV, TYLENOL. Chills, fever (101.9), eye red and burning. H/A, dizziness, SOB, sensitivity to touch (pin-prickly feeling), mild cough, nasal congestion, weakness. H/A and weakness diminishing, but still present on 11/17/08.				Y					Y	11/14/2008	11/14/2008	0	CBC; BMP; Cardiac Enzymes; CXR; EKG; Blood cultures - essentially normal (WBC - 1200)	PUB	PVT	ASA, 81 mg q d	None	Iodine dye; ZYBAN			1						1	Asthenia; Blood culture; Cardiac enzymes; Chest X-ray; Chills; Cough; Dizziness; Dyspnoea; Electrocardiogram; Eye burns; Full blood count; Headache; Hyperaesthesia; Metabolic function test; Nasal congestion; Ocular hyperaemia; Pyrexia; White blood cell count decreased	FLU3~SANOFI PASTEUR~U2740AA~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334560	12/09/2008	ME	41.0	41		F	11/13/2008	Employee came in with complaints of red itchy eyes - feel a tickle in throat - questions difficulty/itchy throat - developed these signs at 13:00 given flu shot at 09:00									Y	11/06/2008	11/06/2008	0	None	PUB	PUB	AMBIEN	None				1						1	Eye pruritus; Ocular hyperaemia; Throat irritation	FLU3~SANOFI PASTEUR~U2828AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334564	12/09/2008	CO	1.9	1	.9	F	11/19/2008	Rash onset 11/6, initially attributed to AMOXICILLIN, but progressed to bruising rash diagnosed Henoch Schonlein Purpura, 11/7				Y					Y	10/23/2008	11/06/2008	14	OBC - (WBC 12.3) unable to get urinalysis	PVT	PVT	AMOXICILLIN at time of rash	None	None			1						1	Contusion; Full blood count; Henoch-Schonlein purpura; Rash; White blood cell count increased	FLU3~SANOFI PASTEUR~UT2782CA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334565	12/09/2008	OH	71.0	71		M	11/26/2008	(L) eye neuroretinitis with visual loss. Progressed gray 10/17, black 10/27/08. Slight improvement 11/24/08 after steroids.								Y	U	09/30/2008	10/17/2008	17	Low IgM; CT brain, 11/26/08, normal; CT orbits, 11/26/08, normal; blood CRP, 1.8	PVT	PVT				Reaction to flu shot 1960's when working at Pgh Plate Company. Came in full-blown flu-like illness x (off work 3 wks), ached all		1						1	Blindness; Blood immunoglobulin M decreased; C-reactive protein increased; Computerised tomogram normal; Optic neuritis; Scan brain	FLU3~SANOFI PASTEUR~U275AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0334566	12/09/2008	TX	38.0	38		M	11/23/2008	Spontaneous onset of recurrent diarrhea, vomiting, nausea. Patient also experienced sweating, feeling faint and eventually within course of 2-3 hours. Complete dehydration which caused radical decrease in BP, impairment of other vital signs. Radical seizing and cramping of most muscles and complete incapacitation. Taken by ambulance to ER, given IV anti nausea ect. Ongoing residual recovery. Still occasional diarrhea, overall weakness, impaired appetite and digestion. Note: Food, salmonella poisoning symptoms suspect but all food sources within last 48 hrs had been shared with spouse demonstrating no adverse  reaction, definitive high WBC response to infection, viral. ER's position conclusion was also an adverse reaction to previous days. Flu vaccine.				Y					N	11/12/2008	11/13/2008	1	Abnormal blood work; very high WBC (white blood count); other???	PVT	OTH	LISINOPRIL; Fluoxetine		Mild hypertension			1						1	Asthenia; Blood pressure decreased; Blood test abnormal; Convulsion; Decreased appetite; Dehydration; Diarrhoea; Dyspepsia; Hyperhidrosis; Muscle spasms; Nausea; Syncope; Vaccination complication; Viral infection; Vomiting; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0334569	12/09/2008	TN	42.0	42		F	11/13/2008	Woke up at 2:00 AM (11-13-08) with swelling under tongue and spread quickly to tongue, lower lip, both jaws and throat. Difficulty swallowing and left for ER. C/O difficulty breathing once arrived at ER.				Y					Y	11/12/2008	11/13/2008	1	None	OTH	PVT	None; except multivitamins		Kidney stones (multiple in both kidneys)			1						1	Dysphagia; Dyspnoea; Lip swelling; Pharyngeal oedema; Swollen tongue	FLU3~SANOFI PASTEUR~U2772AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334571	12/09/2008	NY	48.0	48		M	11/14/2008	Due to right arm pain, patient was given both vaccines in left arm. Large red/hot/swollen area. Left arm 34 cm x 16 cm with hives around edge. Temps of 101 and body aches. Seen by Dr. 11-14-08.									U	11/12/2008	11/12/2008	0	AUGMENTIN 875mg po BID (by mouth twice daily) x 10 days, 11-14-08	PVT	PVT	Insulin pump	None	DM I; no allergies			1						1	Erythema; Pain; Pain in extremity; Pyrexia; Skin warm; Swelling; Urticaria	FLU3~SANOFI PASTEUR~U2795DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1225U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0334572	12/09/2008	NJ	48.0	48		F		Severe U.R.I, Bronchitis; Fever				Y					Y	10/18/2008	10/20/2008	2		OTH	PVT		None	None			1						1	Bronchitis; Pyrexia; Upper respiratory tract infection	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8998~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~10057~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0334574	12/09/2008	MD	34.0	34		F	12/09/2008	Fever, chills, body aches, exhaustion									Y	12/08/2008	12/09/2008	1		UNK	PVT	birth control pills	none	none			1						1	Chills; Fatigue; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0334575	12/09/2008	TX	36.0	36		M	12/09/2008	Headache following administration same day - progressively got worse; coupled with vision problems.  Like no other headache/migraine - crippling pain not dulled buy ibuprofen, motrin, butalbital, or hydrocodone. 12/11/08-records received for DOS 11/18-11/20/08-DC DX:Intractable headache of two weeks duration with failure of outpaitient treatment. Severe low back pain. Recent lumbar puncture. Admitted with severe headache described occipital headache with radiation over head.			Y	Y	Y	3			Y	11/07/2008	11/07/2008	0	Auto-immune encephalitis due to flu vaccine 12/11/08-records received-Lumbar puncture negative. MRI negative pathology but revealed mild arthritic changes.	UNK	UNK	None	None	None			1						1	Autoimmune disorder; Encephalitis; Headache; Migraine; Pain; Visual impairment	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0334576	12/09/2008	OH	46.0	46		F	12/09/2008	Patient reports extreme soreness even at rest, swelling, pain with movement, & decreased range of motion which started immediately after receiving the vaccine. Sx going on now x 4 wks. She reports having throbbing pain immediately after flu shot was given.  She says she has had flu shots in the last 2 yrs and never had any adverse symptoms like this.  Pain rated 9/10 and it keeps her awake at night.  Tylenol/Ibuprofen helps only a little.  She reports that it is just as painful now 4 wks later.  I advised her to see a doctor because she has not yet been seen by a physician to evaluate this.									U	11/07/2008	11/07/2008	0	None	PUB	PUB	Multivitamin	None	Hay fever			1						1	Joint range of motion decreased; Pain; Sleep disorder; Swelling	FLU3~SANOFI PASTEUR~U2832AA~3~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334577	12/09/2008	VA	67.0	67		M	12/09/2008	About six hours after receiving a flu shot, my eyes became bloodsgot and itchy.  the glands under my chin became swollen, as did my salivary glands, and I became extremely fatigued.  i took some Benadryl, and that seemed to help, although the fatigue continued. the next morning, i still felt very fatigued, but the other symptoms had receded, but not disappeared.  I have received flu shots for the past 17 years with no adverse effects until now.									Y	12/08/2008	12/08/2008	0		PVT	PVT			penicillin			1						1	Eye pruritus; Fatigue; Lymphadenopathy; No reaction on previous exposure to drug; Ocular hyperaemia; Salivary gland enlargement	FLUX~UNKNOWN MANUFACTURER~vo4.81~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0334578	12/09/2008	VA	4.0	4		M	12/09/2008	Received vaccines on December 5, 2008 seen at ER on 12/7/08 due to erythema and swelling of left thigh measuring 14x12 cm. Dx cellulitis started on Augmentin. Seen for followup 12/8/08 with erythema decreasing and no mobility limitations.				Y					Y	12/05/2008	12/07/2008	2		MIL	UNK			eczema			1						1	Cellulitis; Injection site erythema; Injection site swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B064AA~6~IM~LL~DTAP (INFANRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500556P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~A0169~5~SC~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0868U~3~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0334583	12/09/2008	WI	18.0	18		F	12/09/2008	5pm on 12/08/2008 patient received vaccine.  By 7:30pm of same date the arm was tender and hurt.  She had a sleepless night, waking up every hour and not being able to fall back to sleep within 20 min. By 9am on 12/09/2008 complained of muscle aches through out her body especially in the arm receiving the vaccine.  No appetite, increased thirst, muscle aches, tiredness and slight fever by 2 degrees.  Took two Tylenol and plans to rest for the day.									N	12/08/2008	12/08/2008	0		UNK	UNK	birth control- YAZ (drospirenone and ethinyl estradiol)	None	None			1						1	Anorexia; Fatigue; Insomnia; Myalgia; Pain in extremity; Pyrexia; Thirst	FLUX~UNKNOWN MANUFACTURER~Vo4.81~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0334584	12/09/2008	OK	59.0	59		F	12/09/2008	Within five minutes of flu vaccine being administered, soldier complained of breathing difficulty.  50mg Diphenhydranine administered IM to left deltoid. BP 133/113 Heart Rate Reg @ 80. Resperations even @ 20. Repeated BP in five minutes 190/110. Speech clear, PERL, ambulatory, Resperations regular even, no difficulty swallowing.  Repeated BP twenty minutes later 182/100. Soldier not having any complaints or symptoms.  Soldier states being tired from benadryl. Advised soldier and commander that soldier needs to seek treatment for HTN through primary care provider on Monday.									Y	12/06/2008	12/06/2008	0		UNK	MIL		None	None			1						1	Dyspnoea; Fatigue	FLU3~CSL LIMITED~01449111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0334585	12/09/2008	CT	26.0	26		F	12/09/2008	patient 12wks gestation given LAIV instead of influenza injectable vaccine-no sx or tx.  2/13/09 MR received for DOS 1/12-13/2009 with D/C DX:  Intrauterine Fetal Demise at 16 weeks.  Oligohydramnios 2' to rupture of membranes. S/P medical induction of labor.  Pt pregnant at 16 wks presented to ER with c/o cramping and bleeding x several days.  Seen 2-3 days prior for same with US OK. on exam membranes noted to be ruptured tinged with blood.  FHTs unable to be obtained manually but 150's on US. Admitted for ROM and UTI. Fetal demise. W/U (-). Labor induced.					Y	1			Y	12/08/2008	12/08/2008	0	none. Labs and Diagnostics:  CBC with WBCs 15.7. OB US (+) severe oligohydramnios. UA (+) for 19 WBCs and 120 RBCs, occ bacteria.  MTHFR mutation 1 copy. UC (-).	UNK	UNK	prenatal vitamin	URI	penicillin-dyspnea; oxycodone-urticaria. PMH: Allergic to PCN.  Smoker			1						1	Drug exposure during pregnancy; Wrong drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500569P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0334587	12/09/2008	IA	22.0	22		F	12/09/2008	Patient began to develop symptoms of erythema nodosum beginning approx. 6 hrs after vaccination. This consisted of multiple red, tender nodules primarily over the extensor surfaces of all 4 extremeties; and painful, swollen knees. New painful red nodules erupted over the course of the next 4-6 weeks, each becoming purply then brown in color before fading completely.  After ~ 7 weeks she returned to normal with no apparent sequelae. OCP were discontinued on 10/24.  No other treatment/medication was given.				Y					Y	10/23/2008	10/23/2008	0	angiotensin-1 converting enzyme: 36 U/L (nl): C3 122 mg/dl (nl): c4 30 mg/dl (nl): ANCA negative: UA 2+ leukocyte esterase, 5-10 WBC: Histone antibody, IgG: 0.2 U (none detected): LFT's normal: ANA <1:40: ASO <55 IU/ml: mycoplasma IgM negative: serum pregnancy test negative:ESR 8: CRP 1.4 (normal<0.5): CBC normal: TSH normal	UNK	UNK	oral contraceptives, rare use of albuterol	none	mild viral induced asthma; severe scoliosis			1						1	Angiotensin converting enzyme; Antineutrophil cytoplasmic antibody negative; Antinuclear antibody positive; Arthralgia; Blood thyroid stimulating hormone; C-reactive protein normal; Complement factor normal; Erythema; Erythema nodosum; Full blood count normal; Histone antibody negative; Joint swelling; Liver function test normal; Mycoplasma serology; Nodule; Pregnancy test negative; Red blood cell sedimentation rate normal; Streptococcal identification test; Tenderness; Urine leukocyte esterase positive; White blood cells urine positive	FLU3~GLAXOSMITHKLINE BIOLOGICALS~U2799BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0334597	12/09/2008	CA	17.0	17		F	12/09/2008	REACCTION TO MCV, SWOLLEN,ITCHY				Y					U	12/02/2008	12/02/2008	0	NONE	PUB	PUB	NONE	NONE	NONE			1						1	Immunisation reaction; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U2833AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0650X~2~IM~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2814AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0334598	12/09/2008	CO	75.0	75		F	12/09/2008	11/12 1350 resident received influenza vaccine on 11/11 to R deltoid—this shift, area where injection given pink, hard and warm  11/12 2015 resident c/o R arm pain upon inspection found a 9 cm x 6cm red raised area that is warm to touch on R upper arm—resident received influenza vaccine to R deltoid on R  Benadryl 25mh 1 cap q 6 hours x 4 doses—place influenza VAC on chart as allergy									Y	11/11/2008	11/12/2008	1	none	UNK	UNK						1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334601	12/09/2008	TX	13.0	13		F	12/09/2008	Client received four vaccines. I asked if she was okay she said yes after standing up for about five minutes. I was explaining every thing to her brother she suddenly fell to floor. Immediately went to check her she responded immediately laughing stated that she was hungry. After a brief assessment of her there were no apparent injuries noted. Parent stated client faints everytime that she gets vaccinated. Client was advised to go get something to eat. Also, responsible party was advised to notify nurses prior to having client vaccinated.									Y	12/09/2008	12/09/2008	0	Na	UNK	UNK		N/A				1						1	Fall; Syncope	FLU3~SANOFI PASTEUR~SPU2791BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U28144AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B030AA~1~IM~RA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1283X~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0334604	12/09/2008	CO	11.0	11		M	12/09/2008	After RN administered TdaP (Tetanus, diphtheria, acellular pertussis vaccine), Menactra (meningococcal vaccine), and Fluzone (influenza vaccine), the patient collapsed and RN immediately moved the client to a supine position.  RN applied a cold cloth.  The patient was pale but color returned after 1 minute lying down.  The patient improved slightly, but then after two minutes he experienced a second unconscious episode and was unresponsive for 30 seconds.  RN assessed the patient the client opened his eyes, began mumbling, and was able to respond to verbal commands.  RN elevated his legs while other RN took his blood pressure (100/60), pulse steady and strong.  Continued to monitor the client.  After approximately 5 minutes, the patient's speech became unintelligible.  His tongue and lips appeared swollen. Requested assistance. RN assessed the client and determined that he had difficulty breathing and some itching.  RN immediately administered 0.3 ml Epinephrine IM per Standing Orders.  Requested that 911 be called.  RN noted a marked improvement in the client following epinephrine injection including more alertness.  Paramedics arrived and placed an IV.  They gave IV Benadryl and transported the patient to Medical Center.   When he left our facility, the client was conscious, showed no signs of respiratory distress, and was responsive to questions. 1/8/09-records received for DOS 12/9-12/10/08-DC DX: Anaphylactoid reaction most likely to Menactra vaccine. 15 minutes after receiving vaccine C/O tightness in throat and seemed to pass out. facial edema.			Y	Y	Y	1			Y	12/09/2008	12/09/2008	0	No further testing	UNK	UNK		None	No known drug or food allergies. 1/8/09-records received-PMH: asthma.			1						1	Dyspnoea; Immediate post-injection reaction; Lip swelling; Loss of consciousness; Pallor; Pruritus; Swollen tongue; Syncope; Unresponsive to stimuli	FLU3~SANOFI PASTEUR~U2828AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2661AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B027AA~1~IM~LA~TDAP (BOOSTRIX)~1	USA	Life Threatening,Hospitalisation	Influenza
0334605	12/09/2008	OH	48.0	48		F	12/09/2008	Pain similar to being frogged at the injection site. Constant ache that is always there.  Intensifies when lift arm up or pressing on the site.  Also hurts when lying on the arm.  Only subsides with medication NAPROXEN 500 mg twice a day.  This pain is very similar today as it was on the afternoon of the injection.				Y					N	10/16/2008	10/16/2008	0		PUB	UNK		none	none			1						1	Injection site pain	FLUX~UNKNOWN MANUFACTURER~~7+~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0334620	12/09/2008	TX	3.0	3		F	11/25/2008	A serious spontaneous report of erythema multiforme has been received from a physician concerning a three-year-old female, subsequent to FLUMIST.  Concomitant medications included mometasone furoate, loratadine and montelukast for allergic rhinitis and congestion (patient had a prescription but physician was not sure if the patient took montelukast).  On 17-Oct-2008, the patient received FLUMIST.  She never received FLUMIST before.  The following day on 18-Oct-2008, the child developed a rash which progressed and was described as a bullseye rash all over body.  On 19-Oct-2008, the patient was hospitalized for erythema multiforme.  The patient was hospitalized for three days.  The reporting physician did not have the patient's hospital records.  On 24-Oct-2008, the patient recovered from erythema multiforme.  Additional information received on 25-Nov-2008 was incorporated into the above narrative: a diagnosis, concomitant medication, medical history, and demographics. Follow up was obtained the Lot Number was not available.					Y	3			Y	10/17/2008	10/18/2008	1		PVT	PUB	NASONEX; LORATADINE; SINGULAIR	Allergic rhinitis; Nasal congestion			MEDI0007533	1						1	Erythema multiforme; Rash generalised	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0334621	12/09/2008	GA	18.0	18		M	12/04/2008	The Chief at facility called to report a case of Myopericarditis. The patient is an 18 y/o male who received primary SPV, AVA #1, Typhoid IM, and FLUMIST on 31 Oct 2008. He developed Flu like symptoms and chest pain requiring hospitalization on 11/29/08. Symptoms: Nausea w/ vomiting. 12/26/08-records received-chest pain. 3-3 days after vaccine C/O flu-like illness, mild headache, cough sore throat, general body achiness then would feel well and symptoms returned and included chest pain on 11/26/08. Diagnosis myocarditis, acute.				Y	Y	4			U	10/31/2008	11/29/2008	29	The patient was hospitalized at a hospital therefore there are no records of laboratory and x-ray results available for review. Phone consultation with the Infectious Diseases physician providing patient care yields the following verbal laboratory results: 1. Abnormal echocardiogram with 40-45% ejection fraction. 2. Abnormal EKG with ST-T wave changes. 3. Elevated Troponin with a peak measurement of 34. The health center is in process of requesting medical records to corroborate the verbal reporting.  12/26/08-records received- EKG abnormal and cardiac enzymes abnormal.	MIL	MIL	None	None	No known drug, medication, food, or latex allergy.			1						1	Chest pain; Echocardiogram abnormal; Ejection fraction decreased; Electrocardiogram; Electrocardiogram ST-T change; Influenza like illness; Myopericarditis; Nausea; Troponin increased; Vomiting	ANTH~UNKNOWN MANUFACTURER~~UNK~SC~UN~ANTHRAX (NO BRAND NAME)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500549P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~UNKNOWN MANUFACTURER~~UNK~ID~UN~SMALLPOX (NO BRAND NAME)~1|TYP~SANOFI PASTEUR~B03472~UNK~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Hospitalisation	Influenza
0334623	12/09/2008	TX	59.0	59		M	12/09/2008	Injection site rxu described by patient's wife so not actually seen by us.  Described an almost blister - like rxu near injection site (no latex allergy) & area at site has had skin peel off.  Pt is currently applying NEOSPORIN ointment and keeping area covered.									U	12/05/2008	12/05/2008	0	N/A	OTH	PVT	Nothing at our pharmacy	None	Codeine Allergy			1						1	Injection site reaction; Injection site vesicles; Skin exfoliation	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89987~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334624	12/09/2008	NH	0.6	0	.6	F	12/09/2008	Pt received 6 mth vaccines on Saturday 12/09/2008 and developed fever with GI Sx within 24 hrs.  Seen in ED early Saturday am returned to office today.  On 12/9 visit-fever 101, still vomiting with diarrhea, decrease in appetite.  No sign of local erythema, edema, warmth at injection sites.				Y					N	12/06/2008	12/07/2008	1		PVT	UNK		URI				1						1	Decreased appetite; Diarrhoea; Pyrexia; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B198AA~3~IM~RA~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2797EA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF511AB~3~IM~LA~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C40031~3~IM~LA~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0334627	12/09/2008	PA	7.0	7		F	11/13/2008	Clients parent reports client developed red localized reaction past receiving immunization on 11/10/08. Redness began on 11/12/08 Rt. arm- mildly between deltoid & elbow, No swelling, pain or discharge. Redness 2 1/2 inches wide,  2 inches - long. MMR given RA SQ.									U	11/10/2008	11/12/2008	2		PUB	PUB		None				1						1	Injection site erythema; Local reaction	FLUN3~MEDIMMUNE VACCINES, INC.~500548P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~MERCK & CO. INC.~0985X~3~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TD~SANOFI PASTEUR~U2027AA~1~IM~RA~TD ADSORBED (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~1012X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0334628	12/09/2008	AL	49.0	49		F	11/12/2008	Rec'd call from Patient 11/12/09.  She reported that at the time of the injection she felt the usual amount of pain but 3 hours later she could not lift her arm.  Had an appointment with Dr. for a turned left ankle 11/6/2008.  While there asked about shoulder.  Ultra sound fx's ordered.  Shoulder continues to hurt.				Y					U	10/21/2008	10/21/2008	0		OTH	PUB		None	Grass Allergies			1						1	Injected limb mobility decreased; Musculoskeletal pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA349CD~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0334629	12/09/2008	NY	3.0	3		M	11/12/2008	Father noticed red rash on right arm 11/11/2008 pm, site of flu injection.  Removed band-aid on 11-7-08 & there was no signs of redness.  Treated with zyrtec for urticarial region right upper arm.									U	11/05/2008	11/11/2008	6		PVT	PVT	None	None	None			1						1	Injection site erythema; Injection site rash; Injection site urticaria; Urticaria	FLU3~SANOFI PASTEUR~U2810AA~3~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334630	12/09/2008	NC	73.0	73		F	11/14/2008	Right deltoid warm, red, swollen and painful.									Y	11/10/2008	11/11/2008	1		PVT	PVT		None	Allergic to: ARAVA and sulfa; CVA; history of bronchitis; tobacco user			1						1	Erythema; Oedema peripheral; Pain in extremity; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89124~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0867X~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0334631	12/09/2008	MS	23.0	23		F	11/13/2008	Redness at injection site, swollen and left arm felt heavy, cold pack applied 1:50pm BENADRYL 25 mg given by mouth and ADVIL 200 mg by mouth for pain.									Y	11/12/2008	11/12/2008	0		PVT	PVT						1						1	Injection site erythema; Injection site swelling; Sensation of heaviness	FLU3~SANOFI PASTEUR~U2705AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334632	12/09/2008	MS	55.0	55		F	11/13/2008	Redness, swelling & itching at injection site- BENADRYL 25 mg PO given @ 8:30 pm.  Zyrtec 10 mg given PO @ 11:00 am.									Y	11/12/2008	11/12/2008	0		PVT	OTH						1						1	Injection site erythema; Injection site pruritus; Injection site swelling	FLU3~SANOFI PASTEUR~U27500AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334633	12/09/2008	VA	56.0	56		M	11/13/2008	Less than 10 minutes after receiving influenza vaccine, patient noticed metallic taste on roof of mouth.  It disappeared after lunch but noticed again in afternoon, then disappeared and has not recurred.									Y	11/12/2008	11/12/2008	0	None	PUB	PUB	SYNTHROID, ARENDOL, LISINOPRIL, CRESTOR, ECASA, NTC, PRN, FOLOCE, FISLIOIL.	None	Heart attack 2000, thyroid condition	None~ ()~~0.00~In Patient		1						1	Dysgeusia	FLU3~SANOFI PASTEUR~U2805AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334634	12/09/2008	RI	27.0	27		F	10/29/2008	Pt. states that approximately 20 minutes after receiving vaccine she noted pain radiating up to left wrist. This sensation has continued more intermittent at the present, no inflammation at site.									N	10/29/2008	10/29/2008	0		OTH	UNK	Clonazepam	None	Allergies- to Penicillin and Sulfa, Ceclor			1						1	Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89738~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334635	12/09/2008	WI	64.0	64		F	10/31/2008	hives on face- skin peeling difficulty breathing- leaching out.  Flu like feeling, dizzy, headache, diarrhea, throwing up.				Y					U	10/23/2008	10/24/2008	1		OTH	PVT	None	None	None			1						1	Diarrhoea; Dizziness; Dyspnoea; Headache; Influenza like illness; Skin exfoliation; Urticaria; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0334636	12/09/2008	NC	61.0	61		F	11/12/2008	Immediate localized swelling around injection site.  Applied pressure X 10 min., then Re pack X 10 minutes.  Swelling mostly resolved, positive hematoma.									Y	11/12/2008	11/12/2008	0	N/A	UNK	UNK		None	None	None~ ()~~0.00~In Patient		1						1	Haematoma; Immediate post-injection reaction; Injection site swelling	FLU3~SANOFI PASTEUR~U2795AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334638	12/09/2008	AZ	40.0	40		F	11/12/2008	Received both flu + pneumonia shots.  Went shopping & came back 2-3 min later, said she didn't feel right; face flushed, arms red, some difficulty breathing.  Sat down, ice to neck.  After abt 20 min was better.  No longer flushed & able to breath.  Later she started having flu symptoms- fever, chills, & heat lasted till next day.									Y	11/10/2008	11/10/2008	0	0 did not go to doctor	PUB	PVT						1						1	Chills; Dyspnoea; Erythema; Feeling abnormal; Feeling hot; Flushing; Influenza; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89620~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0551X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0334639	12/09/2008	OH	65.0	65		F	10/31/2008	Cellulitis at injection site. Started patient on antibiotics for cellulitis today (10-31-08) advise if not improved tomorrow see PCP if worse later today go to ER.									U	10/29/2008	10/30/2008	1	None	OTH	OTH	Benicar; Nexium	None	No allergies; H/O HTN; GERD			1						1	Injection site cellulitis	FLU3~SANOFI PASTEUR~U2831AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1382U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0334640	12/09/2008	MA	61.0	61		F	11/11/2008	Patient said injection hurt when administered. Patient developed black and blue mark at injection site the day after. Saw her MD a few days later- was still bruised and sore. Called me 11/10/08 to say she was still feeling sore.									U	10/15/2008	10/16/2008	1		OTH	PVT						1						1	Injection site haematoma; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334642	12/09/2008	KY	62.0	62		M	11/10/2008	(L) shoulder pain since flu shot 2 weeks ago. Pt. expected soreness, but he still has trouble lifting it. Pt. states injection given fairly high in his deltoid. Pt. referred to physical therapy.				Y					U	10/28/2008	10/29/2008	1	None	PVT	PVT		None Known	HTN; DM II; Hyperlipidemia; Prostate CA (cured)			1						1	Joint range of motion decreased; Musculoskeletal pain	FLU3~SANOFI PASTEUR~U2810AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334649	12/09/2008	OH	44.0	44		F	11/05/2008	Within 20 minutes of FLUZONE shot got the chills felt like fainting, throwing up and or having a bowel movement.  Called husband to come and get me.  Went home to bed...slept.  2 hours later had 101.2 degrees and by 5:30 had a 102 degrees temperature.  No other symptoms.  Next day had 100 degrees temperature by evening was 99 degrees.  Fine on Wed. 11/5/08									Y	11/03/2008	11/03/2008	0	None	UNK	UNK		None	High blood pressure			1						1	Activities of daily living impaired; Chills; Dizziness; Nausea; Presyncope; Pyrexia	FLU3~SANOFI PASTEUR~U2763AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334650	12/09/2008	FL	44.0	44		F	11/11/2008	Irritation. Skin rash.									Y	10/23/2008	10/25/2008	2		OTH	OTH	Oxycodone; Clozapine; TRILEPTOL					1						1	Rash; Skin irritation	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89968~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334651	12/09/2008	IL	33.0	33		M	10/30/2008	Pt presented for FLU vaccine.  Screening form reviewed  screening question- pt denied any food/med allergies, except mil.  Has had previous FLU shots.  After vaccine administered, pt slumped in chair- unresponsive to verbal commands.  Ready to call 911- pt awake, responsive, unaware he fainted. Pt stayed additional 10 min-alert and oriented.  Called pt at home at 2:30- pt states he feels fine, no complaints.									Y	10/30/2008	10/30/2008	0		OTH	OTH		None	None			1						1	Syncope; Unresponsive to stimuli	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334652	12/09/2008	MN	39.0	39		F	11/11/2008	After about 4 hours patient's throat began to swell, eyes were swollen, lips swelled.  She took oral BENADRYL and went to her home town ETC where she wa given IV BENADRYL.  Swelling subsided completely after 3 days.				Y					Y	11/05/2008	11/05/2008	0		PUB	OTH		None				1						1	Eye swelling; Lip swelling; Pharyngeal oedema	FLU3~SANOFI PASTEUR~U2760AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334658	12/09/2008	CA	19.0	19		F	11/12/2008	Developed rash/bumps/spots all over body				Y					N	11/06/2008	11/06/2008	0		OTH	PVT		None	AMOXICILLIN;  PEDIAZOLE			1						1	Rash generalised	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89987~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0334660	12/09/2008	WA	4.0	4		M	11/20/2008	Swelling and redness at injection site on (R) thigh. Patient c/o itching but no pain.									Y	11/19/2008	11/20/2008	1		PVT	PUB	None	Blood shot eye; Cardiac murmur	Congenital ptosis			1						1	Injection site erythema; Injection site swelling; Pruritus	DTAP~SANOFI PASTEUR~C2957AA~5~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2829AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB259AA~1~IM~RL~HEP A (HAVRIX)~1	USA		Influenza
0334662	12/09/2008	MA	11.0	11		F	12/01/2008	3 weeks ongoing pain around left elbow greatly decreased range of motion. Shot given in (L) shoulder. Treatment on 12/1/08 with twice daily ALEVE and 40 every night PREDNISONE times 5 days.				Y					N	11/10/2008	11/11/2008	1	None	PVT	UNK			mild URI, Asthma			1						1	Arthralgia; Injected limb mobility decreased; Joint range of motion decreased	FLUX~UNKNOWN MANUFACTURER~M2840AA~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0334664	12/09/2008	MT	45.0	45		F	11/29/2008	2 day duration localized, moderate induration and swelling at injection site;  followed by approx 5 days moderate, generalized body myalgia negatively affecting daily activities.  Associated HA throughout duration of symptoms.									Y	11/21/2008	11/21/2008	0		OTH	PVT	None	None	None			1						1	Activities of daily living impaired; Headache; Injection site induration; Injection site swelling; Myalgia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89998~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334666	12/09/2008	NC	19.0	19		M	12/04/2008	19 year old male, ADSM, is referred by primary care physician to FBVHC for evaluation of smallpox vaccine inoculation site concerns and left axillary pain.  Symptoms: flu-like symptoms <96 hours, chest pain, pain, erythema, pruritus				Y					U	11/21/2008	11/26/2008	5	Troponin, negative; CPK, normal; CPK-MB, negative; CBC, normal	MIL	MIL	None	None	No known drug,food,medication or latex allergies. No active medical illnesses, no birth defects			1						1	Axillary pain; Blood creatine phosphokinase MB; Blood creatine phosphokinase normal; Chest pain; Erythema; Full blood count normal; Influenza like illness; Injection site reaction; Pain; Pruritus; Troponin	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB195AB~UNK~IM~UN~HEP A (HAVRIX)~1|SMALL~UNKNOWN MANUFACTURER~~UNK~OT~UN~SMALLPOX (NO BRAND NAME)~1|TYP~SANOFI PASTEUR~B03472~UNK~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0334668	12/09/2008	MA	31.0	31		F	12/09/2008	Developed hives right arm to neck, chest tightness, left arm.  Hot flushed face.  To ER. Pulse 110. BP 148/90, O2 satl 100% on room air.   No c/o breathing difficulties.  IV lock with SOLUMEDROL 125 mg IV @ 11:10, ZANTAC 50 mg IV @ 11:14.  BENADRYL 10 mg IV @ 10:55.  Symptoms resolved.  D/C from ER @ 11:44, scripts for ZANTAC X 5 days &  PREDINSONE X 4 days.				Y					Y	12/08/2008	12/08/2008	0	Pulse 110. Sinus tachycardia without ectopy.  Oxygen level 100% on room air.	PUB	OTH			Brain Tumor-due for chemo treatment in 2 days.  No known allergies.			1						1	Chest discomfort; Flushing; Heart rate increased; Hot flush; Oxygen saturation normal; Sinus tachycardia; Urticaria	FLU3~CSL LIMITED~02549111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0334669	12/09/2008	MA	1.3	1	.3	M	12/04/2008	fever 104 degrees, rash on trunk - macules and erythematous palpules on erythematous background, Novesicles. About 8 lesions									Y	11/25/2008	12/04/2008	9		PVT	PUB	None	None	None			1						1	Pyrexia; Rash; Rash erythematous; Rash maculo-papular	FLU3~SANOFI PASTEUR~UT2783FA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1079X~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1002X~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0334670	12/09/2008	OK	67.0	67		U		08 6:30 p.m. Very rapid heart rate 115/min. lasted until 6 a.m. 11-14-08. Arm very sore shoulder to elbow in muscle. 4 days - minor soreness until 11-21-08.				Y					Y	11/12/2008	11/12/2008	0		UNK	UNK	Propanolol 20 mg at bedtime; PPD		Gluten and pepper (spice)			1						1	Heart rate increased; Pain in extremity	FLU3~SANOFI PASTEUR~U2770AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334671	12/09/2008	MH	1.02	1	.0	F	12/09/2008	None stated									Y	11/26/2008	12/04/2008	8	None	PVT	OTH		None				1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U12785DA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1362X~1~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~c71571~4~UN~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1215x~1~UN~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0334672	12/09/2008	AZ	48.0	48		F	10/09/2008	itching, red skin (red)									Y	10/08/2008	10/08/2008	0	None	PUB	OTH			Hypothyroid			1						1	Erythema; Pruritus	FLU3~SANOFI PASTEUR~U2764AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334675	12/09/2008	MA	54.0	54		F	12/09/2008	Pt states developed burning itching eyes then wheezing, flushed hot face, throat felt like it was swelling.  Took a CLARITON dose and a physician gave script for ALBUTEROL.   Symptoms lasted approximately one hour.  (not witnessed by provider.  Pt did not seek ER evaluation)									Y	11/18/2008	11/18/2008	0	None	PUB	OTH	None	None	None			1						1	Eye burns; Eye pruritus; Flushing; Hot flush; Pharyngeal oedema; Wheezing	FLU3~CSL LIMITED~02549111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0334676	12/09/2008	GA	36.0	36		F	12/09/2008	Client had FLUZONE vaccine 11/19/08 - states she started later that evening she started with fever severe aches dizziness, labored breathing - heart rate 96 - states went to sleep and felt ok the next day. Client did not report this until today 12/08/08. Did not go physician. 1st FLUZONE vaccine.									Y	11/19/2008	11/19/2008	0	None	PUB	UNK		None	takes allergy shots			1						1	Dizziness; Dyspnoea; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2769AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334677	12/09/2008	FL	20.0	20		M	11/17/2008	1.Unusual injection site primary SPV, placed on 11-05-08 1 inch above anterior aspect of right elbow, in order to avoid extensive tattoos covering entire area SM's right upper deltoid. Plan, reinforce education of staff administering SPV re correct placement ( okay to administer over tattoos, if no other option). Will bring to attention of VHC educators to review with staff responsible for administering vaccines. Digital photos taken. 2.Local inflammatory response, without S/S of infection, to occlusive tegaderm dressing placed over primary SPV injection site, limiting air circulation to area and impeding normal evolution of scab formation over the JENNERIAN Pustule. SM covered the injection site with tagederm while he bathed. He would dry the area and cover with gauze dressing, secured by adhesive tape(non-paper or microspore kind) and, then, wrap with coban, to hold the dressing in place during maneuvers. He said that he did not use band aids because they would fall off during exercises. Again, the staff administering vaccines need to be educated on proper technique of wound care post SPV vaccination. I am passing this information and sending digital photos to our VHC educators to reinforce proper technique of wound care. 3.Questionable satellite lesion vs. allergic reaction to adhesive tape laterally and medially adjacent to primary JENNERIAN Pustule right upper arm. Reviewed proper wound care and prevention of auto-innoculation with SM.									Y	11/05/2008	11/14/2008	9		MIL	MIL	CLINDAMYCIN; ATARAX;	None	None			1						1	Inflammation; Local reaction; Wrong technique in drug usage process	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|SMALL~UNKNOWN MANUFACTURER~~UNK~~~SMALLPOX (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0334680	12/09/2008	DE	53.0	53		M	12/09/2008	Pruritic rash and local erythema x (times) 2 weeks, treated with PREDISONE 12/9/08.				Y					U	11/25/2008	12/01/2008	6	None	UNK	UNK	ASA; MVI; METFORMIN; CRESTOR; HYZAAR; LISINOPRIL	None	DM; HLP; HTN; DM neuropathy; SCC			1						1	Erythema; Rash pruritic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89994~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0334682	12/09/2008	IL	32.0	32		F	11/15/2008	None stated										11/15/2008				PVT	PVT	81 mg ASPRINE/VITAMINS	None	None			1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~U28811AA~1~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0334683	12/09/2008	WI	48.0	48		F	12/02/2008	Expected arm soreness in the 2 days following vaccination subsided. Then 10 days following vaccination, employee experienced intermittent tenderness and difficulty with her horizontal elevation of arm which has not resolved.									N	10/29/2008	11/09/2008	11		PVT	PVT	81mg Aspirin; Vitamins	None	None			1						1	Injected limb mobility decreased; Pain in extremity; Tenderness	FLU3~CSL LIMITED~01249111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0334684	12/09/2008	WI	53.0	53		F	12/02/2008	Expected arm soreness in the 2 days following vaccination, subsided. Then, 10 days following vaccination, employee experienced intermittent tenderness and difficulty with horizontal elevation of arm. Which has not resolved.									N	10/29/2008	11/09/2008	11		PVT	PVT	LEROTHYROXINE	None	None			1						1	Injected limb mobility decreased; Pain in extremity; Tenderness	FLU3~CSL LIMITED~01249111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0334685	12/09/2008	WI	47.0	47		F	12/02/2008	Expected arm soreness in the 2 days following vaccination subsided. The 10 days following vaccination employee experienced intermittent tenderness and difficulty with horizontal elevation of arm which has not resolved.									N	10/29/2008	11/09/2008	11		PVT	PVT	None	None	None			1						1	Injected limb mobility decreased; Pain in extremity; Tenderness	FLU3~CSL LIMITED~01249111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0334686	12/09/2008	MO	0.57	0	.6	F	11/26/2008	Mom states patient developed fevers Sunday night & continues to run 99-101 degree F.  No other symptom.  States has been giving TYLENOL.  Instructed to notify physician.									Y	11/21/2008	11/23/2008	2		PUB	PUB		None	None			1						1	Pyrexia	FLU3~SANOFI PASTEUR~UT2782FA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334689	12/09/2008	IL	60.0	60		M	11/27/2008	patient received vaccine on 11/24/08. The next day he had swelling under eye, but went away. Then the day after that swelling on bridge of nose, then went away. Then today, swelling on forehead.				Y					U	11/24/2008	11/25/2008	1		OTH	UNK	LISINOPRIL, 40 mg daily	High blood pressure	NKDA, HBP			1						1	Eye swelling; Swelling face	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89998~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0334690	12/09/2008	CT	53.0	53		M	11/14/2008	Mild flu symptoms the day after vaccination. Dry heaves that night. Onset of severe flu symptoms (nausea, feverish, respiratory ailments, severe congestion, abdominal pain, diarrhea, green stool (2-days), shortness of breath, etc)									N	11/05/2008	11/06/2008	1	First time shot patient	MIL	PVT	AZYTHROMYCIN started 11/10/08	None	None			1						1	Abdominal pain; Diarrhoea; Dyspnoea; Faeces discoloured; Influenza; Nausea; Pyrexia; Respiratory tract congestion; Retching	FLUX~UNKNOWN MANUFACTURER~~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0334691	12/09/2008	WI	57.0	57		F	11/25/2008	Received vaccine at about 11:00am.  At 6:00pm,  I began getting hoarse which cleared up about 12:30 or sometime after midnight.									Y	11/14/2008	11/14/2008	0	None	OTH	OTH			Psoriasis			1						1	Dysphonia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0334694	12/09/2008	AZ	8.0	8		M	11/17/2008	Hives around injection site. Treatment- BENADRYL prn.									Y	11/12/2008	11/14/2008	2	None	PVT	PVT	None	None				1						1	Injection site urticaria	FLU3~SANOFI PASTEUR~U2767AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334695	12/09/2008	PA	51.0	51		F	11/17/2008	Received FLUVIRIN shot and 1 to 2 minutes later felt dizzy and felt better after about 5 minutes, 11:55 complained of dizziness BP 148/84, P 64 and reg sitting in a recliner, 12:10 stated her dizziness was gone at about 12:00 and 12:15 BP 122/82, P 72, and no dizziness is present									Y	11/17/2008	11/17/2008	0		OTH	OTH	HTCZ; SIMVASTATIN; ZOCOR	None	None			1						1	Blood pressure increased; Dizziness; Heart rate decreased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88805~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334697	12/09/2008	OH	3.0	3		F	11/17/2008	10 cm wide x 8 cm long area of redness, induration and warmth with a few vesicles (which began today).									U	11/15/2008	11/16/2008	1		PVT	PVT						1						1	Injection site erythema; Injection site induration; Injection site vesicles; Injection site warmth	DTAP~SANOFI PASTEUR~C2999AA~4~UN~LL~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~50G555P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEP~MERCK & CO. INC.~0062X~3~UN~LL~HEP B (RECOMBIVAX HB)~1|HEPA~MERCK & CO. INC.~1259U~1~UN~RL~HEP A (VAQTA)~1	USA		Influenza
0334698	12/09/2008	PA	29.0	29		M	11/18/2008	Vaccine administered 11/12/2008 12:30pm.   At 1:30pm  patient became sleepy, tongue tingled and lips became edematous.  At 2pm he went to his pcp.  Was evaluated for 3/4 hr all tests normal.  Symptoms persisted.  At 4:30 to St Lukes Hospital ER evaluated.  Received IV BENADRYL and PREDNISONE.  Sent home at 7- symptoms resolved.  To continue oral PREDNISONE daily x5 days and f/u with pcp.				Y					N	11/12/2008	11/12/2008	0	Unknown, poss vaccine related response	OTH	UNK	None	None	Stated allergy to coconut			1						1	Lip swelling; Paraesthesia oral; Somnolence	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89976~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0334700	12/09/2008	MD	80.0	80		M	11/17/2008	One hour after receiving vaccine had fast heart rate, pale, weak and SOB.									Y	10/23/2008	10/23/2008	0		MIL	MIL			Sensitivity to simvastatin			1						1	Asthenia; Dyspnoea; Heart rate increased; Pallor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~878772~5~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334702	12/09/2008	MD		38		F	11/14/2008	Day of injection, rash developed on legs and elbows, no fever, very itchy.									Y	11/10/2008	11/10/2008	0		PVT	PVT	Albuteral Inh. Prenatal Vitamins	None	Asthma			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U2760AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334703	12/09/2008	PA	6.0	6		M	11/14/2008	Pt received vaccine Wednesday night. Mom first noted ran last night as red arm/very itchy. No change today 5-6 cm by 4cm cm erythematous swollen left arm, around Flu shot site. No tenderness to touch.				Y					Y	11/12/2008	11/13/2008	1	None	PVT	PVT	Fluoride 0.5 mg daily	None	Seasonal Allergies			1						1	Erythema; Injection site swelling; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0334705	12/09/2008	AZ	31.0	31		F	11/13/2008	Received FLUZONE on 10/29/2008.  On 10/31/2008 in am, pt had taken NASONEX and in pm, pt reported broke - out in hives;  which was raised, pink patches throughout body.   On 11/3/2008 pt to urgent care and received Rx for PREDNISONE, but denied taking PREDNISONE, had only been taking BENADRYL.  On 11/4/08 pt reported body of being cleared from hives.				Y					Y	10/29/2008	10/31/2008	2		PUB	PUB	LEVOTHYROXINE;  CLARITIN	None	Allergies			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2743AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334706	12/09/2008	OH	54.0	54		F	11/17/2008	Arm swelled, hives, fever, itching, pain, tenderness and swelling at injection site. Tenderness/swelling started 11/13/08, approx. 6:30 p.m. Remainder of sx, 11/14/08, AM. Pt. took BENADRYL, p.o.									Y	11/13/2008	11/13/2008	0	None	PUB	OTH			Allergic to red dyes			1						1	Injection site pain; Injection site pruritus; Injection site swelling; Oedema peripheral; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U2831AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1161X~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0334709	12/09/2008	OH	32.0	32		M	11/12/2008	Blood shot and swollen eyes swollen throat, fever, sore throat, chills, muscle aches, fatigue, cough. H/A, muscle aches. Pt stated all symptoms on VIS.									Y	10/23/2008	10/24/2008	1		PVT	PVT		None	elevated cholesterol			1						1	Chills; Cough; Eye swelling; Fatigue; Headache; Myalgia; Ocular hyperaemia; Oropharyngeal pain; Pharyngeal oedema; Pyrexia	FLU3~SANOFI PASTEUR~U2741AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334710	12/09/2008	OH	70.0	70		M	11/17/2008	Within 1 hr. severe pain in upper arm where injected- severe swelling from upper arm down to elbow with redness. This lasted 6 days.									Y	10/29/2008	10/29/2008	0		PUB	OTH			Penicillin-Hydrochlorizde; LEVAQUIN; MONOPRIL; COSAAR; ibuprofen; diabetic			1						1	Erythema; Oedema peripheral; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0334711	12/09/2008	PA	5.0	5		M	11/13/2008	Starting vomiting the evening following FLUZONE immunization. Also had diarrhea. The next morning complained of pain under the arm where immunization given. Developed petichiae around his face after vomiting. Had moderate size area with slightly pinkish hve below (L) arm to mid rib cage on side. Slight swelling No axillary lymphadenopathy.										11/10/2008	11/10/2008	0		PVT	PVT	None	None	No known allergies, cardiac murmur			1						1	Diarrhoea; Injection site pain; Oedema peripheral; Petechiae; Urticaria; Vomiting	FLU3~SANOFI PASTEUR~U2764AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334712	12/09/2008	MA	69.0	69		M	11/15/2008	Chills- Fever- Body pains- Dizziness.									U	08/24/2008				PUB	UNK		None	High sugar- MBS			1						1	Chills; Dizziness; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0334717	12/09/2008	PA	45.0	45		F	12/02/2008	Lightheaded, chest tightness, throat hoarse and tight face flushed. See attached ER note.				Y					Y	11/20/2008	11/20/2008	0	see attached.	PVT	PVT		None	Biaxin			1						1	Chest discomfort; Dizziness; Dysphonia; Flushing; Throat tightness	FLU3~SANOFI PASTEUR~U2832AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334730	12/09/2008	MI	47.0	47		F	12/01/2008	c/o Rash.  Red swelling down arm to wrist.  site hot.  did have tightness in throat.  made her feel gooqy									Y	11/17/2008	11/18/2008	1	None	PUB	PVT	Unknown	None	Unknown			1						1	Erythema; Feeling abnormal; Feeling hot; Oedema peripheral; Rash; Throat tightness	FLU3~SANOFI PASTEUR~U2804AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334765	12/09/2008	OR	9.0	9		F	11/14/2008	Reaction to pneumococcal shot (L) arm IM on 11-10-08.									Y	11/10/2008	11/11/2008	1		PVT	UNK		None	None			1						1	Injection site reaction	FLU3~SANOFI PASTEUR~U2769AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1295X~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0334778	12/09/2008	OH	6.0	6		M	11/12/2008	Pt was seen in office for a follow up URI. Pt was administered a flu vaccine at this time. Came back to office 11/12/08 for a pretty significant reaction.									U	11/10/2008	11/11/2008	1	None	PVT	PVT			None			1						1	Injection site reaction	FLU3~SANOFI PASTEUR~U2760AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0281686	12/10/2008	MI	36.0	36		M	02/14/2008	1. Within 24 hours following receipt of AVA # 6 and INFLUENZA vaccines (given left arm 12/5/2006), developed diffuse arthralgia, myalgia, and numbness and tingling left index finger and thumb. 2. On set 4/2007, extreme physical fatigue, sleeping disturbance, day-time sleepiness, intermittent headaches, short-term memory loss, mood changes, frequent heartburn, constipation, urinary urgency, painless rectal bleeding (2 episodes)- all symptoms decreased and intermittent in nature. Symptoms: Joint pain, multiple joints, start: 12/05/2006 - persist to date; muscle pain, start: 12/05/2006, diffuse - persist to date; paresthesia, start 12/05/2006, left index finger & thumb: initially constant, later intermittent, decreased but not completely resolved to date.				Y					N	12/05/2006	12/06/2006	1	6/11/2007, brain MRI: neg.; 6/12/2007, C-Spine MRI: disc spur complex w/ narrowing R)neural foramen, no central stenosis C3/C4; central disc protrusion w/ mass-effect on cord; no pathologic enhancement; 6/18/2007, LE EMG/NCS: neurophys finding indicative of spinal stenosis L)L5, R)S1 nerve roots; remote L)L5/s1 radiculopathic changes w/o acute component; no neurophys finding indicative of acute plexopathy, inflammyopathy, motor neuron disease, or ongoing radiculopathic denervation changes; 6/19/2007, UE EMG/NCS: L)sided sensory motor primary demyelinating median nerve mononeuropathy at wrist; bilat sensory motor ulnar nerve mononeuropathy at wrists; increased insertional & spontaneous muscle activity at L)C6/7 paraspinal muscles, possibly indicative of early  radiculopathy; no neurophys finding indicative of acute plexopathy, inflammyopathy, or motor neuron disease, or ongoing radiculopathic denervation; 7/24/2007, PSG: normal; 7/27/2007, EMG/NCS UE/LE: essentially normal study w/o compelling electrophys evidence of periph neuropathy, polyradiculopathy, R)lumbosacral or cervical radiculopathy, or R) upper or lower limb mononeuropathy; 7/27/2007, overread brain MRI dated 6/11/2007: 1 cm pineal cyst; 7/30/2007, EGD & colonoscopy: 3 cm hiatal hernia, external non-bleeding non-thrombosed hemorrhoid ; 5/11/2007; ANA titer, 1:320 homog; Cl 108, Alb 5.0, ALT 51; normal or neg: remaining chem, lipids, RF, ESR, T4 free, TSH; 6/7/2007: normal or neg: Anti-myeloperoxidase Abs, Anti-proteinase 3 Abs, C-ANCA, P-ANCA, Atyp pANCA, Siogren's Anti-SS-A/B, Homocyst, ANA direct, VitB12, Folate, Methylmalonic acid, Anti-DNA (D5) Abs, Lyme Abs quant IgM, Sed Rate-Westertgren, Vit B6, CK; 7/31/2007: normal or neg: ESR, CRP, CBC, CMP, CK, ANA AB panel, Anti ENA panel, Cytoplasmic Autoab panel, Iron, TIBC panel, Ferritin, Ceruloplasmin; 9/7/2007: normal or neg: CH50, C3, C4, C1Q binding, C3d, anti-CCP, Parvovirus B19 IgM, positive: parvovirus B19 Ab IgG	MIL	MIL	Currently taking LYRICS daily and TYLENOL # 4 prn		None	Reported prolonged joint and muscle pain following previous anthrax vaccine 1-4 (symptoms lasted 1.5 - 2 weeks)~Anthrax (Biothra		1						2	Alanine aminotransferase increased; Amnesia; Anti-SS-A antibody negative; Anti-SS-B antibody negative; Antineutrophil cytoplasmic antibody negative; Antinuclear antibody; Antinuclear antibody negative; Arthralgia; Blood chloride increased; Blood creatine phosphokinase normal; Blood folate normal; Blood homocysteine normal; Blood immunoglobulin M; Blood thyroid stimulating hormone; Ceruloplasmin normal; Colonoscopy abnormal; Complement factor C3; Complement factor C4; Constipation; Coombs negative haemolytic anaemia; DNA antibody negative; Dyspepsia; Electromyogram normal; Fatigue; Full blood count normal; Headache; Hypoaesthesia; Immune complex assay; Iron binding capacity total normal; Laboratory test normal; Lipids normal; Metabolic function test normal; Methylmalonic aciduria; Micturition urgency; Mood altered; Myalgia; Nerve conduction studies normal; Nuclear magnetic resonance imaging abnormal; Nuclear magnetic resonance imaging brain abnormal; Oesophagogastroduodenoscopy; Paraesthesia; Parvovirus B19 serology positive; Proctalgia; Rectal haemorrhage; Red blood cell sedimentation rate normal; Rheumatoid factor negative; Serum ferritin normal; Sleep disorder; Somnolence; Thyroxine free normal; Ultrasound scan normal; Vitamin B12 normal; Vitamin B6 normal	ANTH~EMERGENT BIOSOLUTIONS~FAV102~6~SC~UN~ANTHRAX (BIOTHRAX)~2|FLU3~SANOFI PASTEUR~U2238AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0316502	12/10/2008	IL	20.0			M	10/24/2008	Guillain-Barre syndrome  - Areflexia - Blood product transfusion - Demyelination polyneuropathy - Dizziness - Dysesthesia  - Dysphagia					Y				U	03/21/2008	04/05/2008	15	EMG: Showed evidence of acute demyelination neuropathy.  CT of the brain status post right temporal cranioctromy:  revealed a	UNK	UNK	Biciddin		Three-day history of upper respiratory infection, including cough and		200802882	1						2	Acute sinusitis; Areflexia; Asthenia; Cough; Craniectomy; Dizziness; Dysaesthesia; Dysarthria; Dysphagia; Dyspnoea; Fatigue; Hyperaesthesia; Malaise; Muscular weakness; Neuropathy peripheral; Pyrexia; Rhinorrhoea; Throat tightness; Upper respiratory tract infection; Wheezing; Areflexia; Blood product transfusion; Craniotomy; Demyelinating polyneuropathy; Dizziness; Dysaesthesia; Dysphagia; Electromyogram abnormal; Guillain-Barre syndrome; Scan brain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA050A~1~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB108AA~1~IM~LA~HEP A + HEP B (TWINRIX)~1|MMR~MERCK & CO. INC.~0871U~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|MNQ~SANOFI PASTEUR~U2567AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2869AA~1~IM~LA~TDAP (ADACEL)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLAO5GA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~2|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB1C8AA~UNK~IM~LA~HEP A + HEP B (TWINRIX)~2|MNQ~SANOFI PASTEUR~U2567A~UNK~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TDAP~SANOFI PASTEUR~C2864A~UNK~IM~LA~TDAP (ADACEL)~2	USA	Hospitalisation	Influenza
0328370	12/10/2008	IL	12.0	12		M	10/15/2008	This non-serious case was received from a health professional on 13 October 2008.  A 12-year-old female patient, with no reported medical history.  An 11-year-old female patient received an intramuscular left deltoid injection of MENACTRA (lot number U2639AA), a right deltoid intramuscular injection of ADACEL (lot number C2996AA) and a subcutaneous injection of VARIVAX to back of left arm (MERCK, lot number 0443X) on 19 September 2008.  The following day, each of the three administration sites showed a 6cm area that was red, painful and swollen and both arms were aching.  The patient was seen in the doctor's office on 22 September 2008.  The symptoms resolved in a few days after 9/22/08.  The patient had no other symptoms or reactions.									Y	10/13/2008	10/13/2008	0		UNK	UNK			None reported.		200803196	1						4	Dizziness; Nausea; Vomiting; Injection site erythema; Injection site pain; Injection site swelling; Pain	FLUN3~MEDIMMUNE VACCINES, INC.~500545P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U2618AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2767AA~6~IM~RA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1140X~2~SC~RA~VARICELLA (VARIVAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500548P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~4|MNQ~SANOFI PASTEUR~U2618A~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~4|TDAP~SANOFI PASTEUR~C2767A~1~IM~RA~TDAP (ADACEL)~4|VARCEL~MERCK & CO. INC.~1140X~2~SC~RA~VARICELLA (VARIVAX)~4	USA		Influenza
0334611	12/10/2008	IL	19.0	19		F	12/10/2008	Patient, a previously healthy 19 year-old female college freshman died suddenly yesterday, approximately 10 days after receiving Gardasil & menningococcal vaccines. Vaccines were administered by a medical provider in her hometown while she was home for the Thanksgiving holiday, sometime around 11-28-08. She had a medical appointment pending for 12-8-08 (the day of her death) with the Student Health Service; medical clerk had entered possible seizure as the reason for making the appointment. Patient had no history of epilepsy. She complained of a headache and not feeling well in the 24 hours prior to her death. She went to bed at 10:30 PM on 12-7-08, in her dorm room with a roomate. She appeared to still be sleeping the next morning when her roomate left for class. Her body was discovered still in bed around 5 PM that day (12-8-08) with rigor mortis. No history of substance abuse, alcohol intake, or depression or other mental health issues. She was a happy, achieving student. This report is filed by a friend of patient's parents, who is a physician (board certified internal medicine & geriatrics). Report also filed online today with the FDA. Patient's mother can be reached at home for additional details. Memorial service & funeral 12-12-08 and 12-13-08. Only known past medical history requiring physician attention was facial acne.  12/10/2008 Recived records from health center via CDC. Seen 11/3/08 with c/o sore throat, cough, muscle aches and nasal d/c. PE (+) for pharyngeal erythema, purulent nasal drainage, nasal turbinate changes, and lymphadenopathy. Assessment: Probable viral URI with ? sinusitis. Tx:  Biaxin.  Received from CDC via email: The patient had no previous health problems. She was a freshman and was seen at the college health clinic only once on 11/3/08 for sinusitis. She was on Yaz birth control pills and a topical acne medication. After the death, police questioned her roommate who said that the pt did go out on the evening of 12/6/08 and had a few alcoholic drinks, but not an excessive amount. She had a HA the next day and thought it was from the alcohol. She had a PCN allergy and was a non smoker.   12/11/2008 Records received from PCP.  HPV#1 1/18/2008.  HPV#2 3/28/2008. Vaccines deferred 7/29/2008 2' to oral prednisone usage for acne (with Bactrim).  Seen 8/15/08 for sore throat, runny nose. DX: Pharyngitis s/p steroid tx. Returned for vaccines 11/26/2008 in good health with normal exam. Additional record also received from health center for scheduled appt on 12/8/08. Pt reported 2 episodes (one 1 month ago and one on the day of death) of waking up in a cold sweat, having urinated in the bed, feeling the urge to vomit, dizzy with trouble reading. Appt made for ? seizure. Pt did not arrive for appt.  3/3/09 Autopsy report received.  COD:  Unable to ascertain after autopsy, microscopic, toxicologic and chemical evaluation.	Y	12/08/2008							N	11/26/2008	12/08/2008	12	Autopsy performed 12-9-08 was unrevealing per family verbal report to me; no signs of intracranial bleed, meningitis, cardiomyopathy, trauma. Toxicology report still pending at this time. Post-mortem tox screen (-).	UNK	UNK	None known. ?? oral contraceptive or an antibiotic for acne.	None.	Acne. PMH:  PCN allergy. Acne. On OCs (Yaz). 12/10/2008 Recived records from health center via CDC. Seen 11/3/08 with c/o sore throat, cough, muscle aches and nasal d/c. PE (+) for pharyngeal erythema, purulent nasal drainage, nasal turbinate changes, and lymphadenopathy. Assessment: Probable viral URI with ? sinusitis. Tx:  Biaxin.			1						1	Autopsy; Death; Headache; Malaise; Autopsy; Death; Headache; Malaise; Death; Dizziness; Headache; Malaise; Nausea	FLUN3~MEDIMMUNE VACCINES, INC.~500569P~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0070X~3~~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2730AA~UNK~~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|HPV4~MERCK & CO. INC.~~UNK~UN~UN~HPV (GARDASIL)~2|MEN~UNKNOWN MANUFACTURER~~UNK~UN~UN~MENINGOCOCCAL (NO BRAND NAME)~2|HPV4~MERCK & CO. INC.~~UNK~UN~UN~HPV (GARDASIL)~3|MEN~UNKNOWN MANUFACTURER~~UNK~UN~UN~MENINGOCOCCAL (NO BRAND NAME)~3	USA	Results in Death	Influenza
0334779	12/10/2008	CO	13.0	13		F	12/01/2008	Patient received HAVRIX, FLUZONE, GARDASIL.  After receiving shots she was sitting on chair and felt really dizzy --> Fell on to floor (+LOC).  She woke up on the floor.  Approximately 5 to 10 after event, no pain,  vitals normal, A&O X3.									Y	11/26/2008	11/26/2008	0	None	PVT	PVT	None	None	Unknown			1						1	Dizziness; Fall; Immediate post-injection reaction; Loss of consciousness	FLU3~SANOFI PASTEUR~U2751AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB260AA~1~UN~LA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~0650X~1~UN~RA~HPV (GARDASIL)~1	USA		Influenza
0334797	12/10/2008	IN	20.0	20		F	12/03/2008	11/27/2008 pt noticed red area at injection site size of a quarter warm to touch and swollen.  C/o rash all over.  Pt advised to put ice pack on area and take BENADRYL which did help when pt got hot and made worse over time 11/27/08 + 11/28/08 + 11/29/08 area went away.									Y	11/25/2008	11/27/2008	2		PVT	PVT	None	None		rash~Hep B (no brand name)~2~18.00~In Patient		1						1	Feeling hot; Injection site erythema; Injection site swelling; Injection site warmth; Rash generalised	FLU3~SANOFI PASTEUR~63009~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334798	12/10/2008	MI	38.0	38		M	11/24/2008	11/20/08, client called to inform County Health Division that after receiving INFLUENZA vaccine at 3:30 pm on 11/19/08. At about 6:30 pm, developed watery eyes, wheezing difficulty breathing and was driven to hosp. ER by a friend. At ER was started on IV fluids, given antihistamine steroids and a breathing treatment. Client was discharged home at 8 pm with a prescription for a steroid x 4 days and prn antihistamine. Client recovered by 11/20/08. Returning to work that AM. Had never had a flu shot previously. Tetanus vacc. 4 mons prior - no reactions.				Y					Y	11/19/2008	11/19/2008	0		PUB	PUB	None	None	No allergies; no other conditions; no egg allergy		M12008030	1						1	Dyspnoea; Lacrimation increased; Wheezing	FLU3~SANOFI PASTEUR~U21615~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334800	12/10/2008	NH	1.02	1	.0	U	12/06/2008	Rash.				Y					Y	11/25/2008	12/06/2008	11		PVT	PUB		None	Colic; GERD; Eczema			1						1	Rash	FLU3~SANOFI PASTEUR~UT2792CA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1084X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1187X~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0334802	12/10/2008	CA	76.0	76		F	10/31/2008	Within 3 hrs of receiving the vaccine, I began shaking uncontrollably. This lasted weeks. Freezing followed by hot flashes where I would be drenched with perspiration. It is now a month later and I am improving, but still experiencing some symptoms.									Y	10/01/2008	10/01/2008	0	None	PVT	OTH			HTN; hyperlipidemia; hypothyroid; All: Ciprofloxacillin			1						1	Feeling cold; Hot flush; Hyperhidrosis; Tremor	FLU3~SANOFI PASTEUR~U2766AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334851	12/10/2008	WI		47		F	12/10/2008	Individual reported to employer that one week post vaccination expereinced and was diagnosed with Bell's Palsy;  primary care physician indicated that he felt is was related to the influenza vaccination				Y					U	10/27/2008	11/03/2008	7		UNK	PVT	Unknown	None reported	Reported: peripheral neuropathy;  Individual shared that she also had an episode with Bell's Palsy 25 years ago			1						1	Condition aggravated; Facial palsy; Vaccination complication	FLU3~CSL LIMITED~01349111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0334852	12/10/2008	AR	55.0	55		M	12/10/2008	Patient was given PPD Vaccine 0.5ml IM by mistake in the right deltoid. Patient was to receive Tdap 0.5ml IM. Patient was briefed on possible side effects and what to do by Dr.									Y	12/07/2008			None. Patient showed know adverse effects at 24 and 48 hours post vaccination.	MIL	MIL	NONE	None and no adverse effects noted by patient at 24 and 48 hours post vaccination.	None			1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0334853	12/10/2008	LA	12.0	12		F	12/10/2008	Immediatly following the vaccine of the Gardisil or HPV she lost partial hearing and had leg paralysis. She fainted and felt nauseated. She was excused to leave less than 10 minutes later. Less than 2 hours later the leg paralysis returned as did the fainting and nausea. The ER doctor stated she had severe low blood pressure that could be causing the inability to use her legs.				Y					Y	11/14/2008	11/14/2008	0		PVT	UNK						1						1	Hypoacusis; Hypotension; Immediate post-injection reaction; Monoplegia; Nausea; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~1~~~HPV (GARDASIL)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~~~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0334854	12/10/2008	MA	24.0	23		F	12/10/2008	Day following injection, pt reports feelings of pounding heart and shortness of breath. This symptoms resolved same day. When seen in office on 12/8 reporting: no pain but some residual feelings of L arm numbness/tingling  radiating down to fingers - feeling like her finger are falling asleep.									Y	11/17/2008	11/18/2008	1		UNK	UNK	Acetaminophen 500 mg, Caltrate Plus 600/400, Levothyroxine 75 mcg, Glyburide 2.5 mg.	No acute illness at visit	Diabetes II, Hypothyroidism, Obesity, Allergy to Vancomycin causing itchiness	unknown~ ()~~0.00~Patient|unknown~ ()~~0.00~Sibling|unknown~ ()~~0.00~Sibling		1						1	Dyspnoea; Hypoaesthesia; Palpitations; Paraesthesia; Pruritus; Type 2 diabetes mellitus	FLU3~SANOFI PASTEUR~U2769AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334855	12/10/2008	PA	36.0	36		F	12/10/2008	Experienced high fever(102) x3 days, runny nose, headache, soreness in shoulders, arms, hands and nose. Day three experienced cough, sore throat and swollen lymph glands in neck.				Y					N	12/07/2008	12/08/2008	1		MIL	UNK		NONE	NONE			1						1	Cough; Headache; Lymphadenopathy; Musculoskeletal pain; Nasal discomfort; Oropharyngeal pain; Pain in extremity; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~Hoo3887~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0334856	12/10/2008	NC	3.0	3		F	12/10/2008	Fluvirin .25 was given to this 3 year old.  The vaccine is licensed for 4 years and up.									Y	12/10/2008			none	PVT	PVT		none	none			1						1	Inappropriate schedule of drug administration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89969~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334864	12/10/2008	CA	55.0	55		F	11/25/2008	Patient developed rash on hands and feet one hour after vaccine administered. Benadryl 25 mg po and Tylenol 650 mg po given.									Y	11/24/2008	11/24/2008	0		PUB	PVT	unknown	Blunt trauma	NKDA			1						1	Rash	FLU3~CSL LIMITED~04549111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0334865	12/10/2008	CA	44.0	44		F	12/05/2008	Employee received flu mist 11/18/08. On 11/23 he relates developed symptoms of dry thraot, cough, and sweats. States developed body aches 11/23/08. Reported to EHOS 12/01.									Y	11/18/2008	11/23/2008	5		PUB	PVT	unknown		Pollens NKDA			1						1	Cough; Dry throat; Hyperhidrosis; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0334866	12/10/2008	TX	2.0	2	.0	F	12/10/2008	Maculo papular rash c/w papular urticaria on back, abdomen and lower extremeties occuring approximately 24 hours after vaccine administration. Also noted to have loose stools.  Treatment with Benadryl 6.25 mg x 1 po then PRN for pruritis q 8 hours with close follow up and referral to Allergy for evaluation for possible egg allergy.									U	12/08/2008	12/09/2008	1		UNK	UNK	None	No	Chronic Otitis Media treated with Tympanostomy Tubes			1						1	Diarrhoea; Pruritus; Rash maculo-papular; Urticaria	FLU3~SANOFI PASTEUR~U2762AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334867	12/10/2008	MT	13.0	13		M	12/10/2008	Platelet count went from 102,000 to 37,000 two weeks post Flu Mist. Blood Sugars began increasing and remain high. Platelet count 12/8/08 still low at 39,000				Y					N	11/14/2008	12/01/2008	17	CBC-platelets 37,000	PVT	UNK	Humalog Insulin	Ideopathic Thrombocytopenia Purpura	Type 1 Diabetes			1						1	Blood glucose increased; Full blood count; Platelet count increased	FLUX~UNKNOWN MANUFACTURER~UNK~2~IN~NS~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~UNK~2~IM~LA~VARICELLA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0334873	12/10/2008	TX	5.0	5		F	12/10/2008	Subject is nearly a 6 year old female child who received FluMist through our school-based influenza vaccination program on October 17, 2008. On November 10, 2008 she was seen at the clinic for a 2 day history of fever, rhinorrhea, sore throat and cough. PE was notable for slight erythematous throat without exudates. Chest was clear to auscultation and she was assessed to have an intercurrent viral illness. She was seen in the emergency room on November 11, 2008 for progressive symptoms which now included conjunctivitis, left sided pain, headache, nonbloody and nonbilious emesis, inability to eat without throwing up and decrease urination. PE was remarkable for ill appearing child with moderate dehydration. Her vital signs were Temp 104.3, BP 104/65 Pulse 146 with an oxygen saturation of 92%. Her oral mucosa was dry, chest was clear to auscultation, abdomen was soft and nontendor. Chest X ray revealed a left lower lobe infiltrate. The child had fluid resuscitation and was started on rocephin 75 mg/kg once per day, and was admitted to the hospital. Lab test: Strep screen was reported negative, WBC: 12,000 with 90% PMNs; and urine analysis was unremarkable except for ketones. Blood culture was obtained prior to starting rocephin and it remained sterile. Repeat CXR on Nov 12, 2008 was consistent with a left pleural collection which increased compared to Nov 11 study, a dense LLL consolidation and a small focus in the lingual (left lung). Patient gradually improved and was discharged on November 14, 2008 on omnicef (14 mg/kg twice a day for 10 days). She was seen for a follow-up visit on December 5, 2008. She had done well since discharge except for a slight cough that was resolving. Final diagnosis: Community acquired pneumonia and dehydration. Past Medical History: none. Medication: none. School: kindergarten. Smoke exposure: none. Influenza vaccine: FluMist. Date of Vaccination: 17 Oct 2008. Date of SAE:  November 11, 2008. SAE: Event was serious and not related to FluMist (This SAE was reported to the agency).  12/19/08 Reviewed hospital medical records of 11/11-11/14/2008. FINAL DX: LLL pneumonia Records reveal patient experienced HA, fever, cough, emesis.  Had rhinorrhea, watery eyes, fever, decreased activity, reduced oral intake approx 3-4 days prior to admit & diarrhea x 1 day, left rib/flank pain x 2 days.  Seen by PCP where strep tests neg & dx w/viral illness.  Did not improve, cough worsened & admitted.  Diarrhea & fever continued in hospital.  Gradually improved on antibiotics & d/c to home on continued antibiotics.					Y	4			Y	10/17/2008	11/11/2008	25	Chest X ray and blood culture  LABS: CXR c/w pneumonia	UNK	UNK	None at the time of vaccination.	None	None.  PMH: migraines, umbilical hernia repair.			1						1	Blood culture negative; Chest X-ray abnormal; Conjunctivitis; Cough; Dehydration; Dysuria; Headache; Heart rate increased; Lung infiltration; Mucosal dryness; Oropharyngeal pain; Oxygen saturation decreased; Pharyngeal erythema; Pyrexia; Rhinorrhoea; Urine output decreased; Viral infection; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500556P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0334875	12/10/2008	WA	7.0	7		M	12/10/2008	12 hours after flu shot, child awoke with severe headache, abdominal discomfort, vomited once. No fever, diarrhea, respiratory or local reaction repoerted.  Described head feeling like it would explode & said it was different than the migraine headaches he experiences.  Child received no treatment & was fine after 4 hours.									Y	11/26/2008	11/26/2008	0		PUB	PUB	Metadate & Clonidine	none	Migraine headaches/ADHD			1						1	Abdominal discomfort; Headache; Vomiting	FLU3~SANOFI PASTEUR~U2808AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334876	12/10/2008	UT	81.0	81		F	12/10/2008	Patien describes swelling, itchy rash, lumps in her head.				Y					U	10/23/2008				PUB	MIL						1						1	Mass; Rash pruritic; Swelling	FLU3~SANOFI PASTEUR~u2831aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334885	12/10/2008					U	12/11/2008	On 26 NOV 2008 we received the following information from the above mentioned literature article: This report describes an outbreak of influenza A (H3N2) in December 2005 to January 2006 at a facility housing children and young adults with severe neurologic impairment, where enhanced infection control measures and adamantine prophylaxis were implemented. The circulating virus was subsequently determined as genotypically resistant to adamantanes. In December 2005 the facility housed 98 residents in five units: unit A  on the first floor and units B, C, D and E on the second floor. There were 19 to 21 residents per unit, 1 to 4 residents per room. All residents had severe neurologic impairments and were nonambulatory. Influenza-like illness (ILI) was defined as fever (temperature greater than 38C) plus acute respiratory symptoms. The case definition for a confirmed influenza case was ILI with onset between 12 December 2005 and 12 January 2006 plus a positive test for influenza (rapid antigen test, viral culture of real-time reverse-transcriptase polymerase chain reaction [RT-PCR]). The case definition for a suspect influenza case was ILI with onset, during the investigation period and no other idenfiied etiology among residents who were either not tested for influenza or tested negative by viral culture or RT-PCR. Failure of antiviral prophylaxis was defined as onset of ILI more than 24 h after initiation of prophylaxis. An outbreak of ILI was recognized on the first floor of the facility and reported to the CDPH in December 2005. Rapid antigen tests performed on two residents were positive with influenza A. The circulating strain was confirmed by RT-PCR at the IDPH Laboratory to be influenza A (H3) and CDPH recommended antiviral prophylaxis for asymptomatic residents and unvaccinated staff in Unit A with amantadine or rimantadine. By 3 days after outbreak recognition, 16 (84 per cent) of the 19 residents in Unit A had developed ILI, 11 of whom were confirmed as having influenza A. Four days after outbreak recognition, a resident of Unit E developed ILI and tested positive for influenza A. Antiviral prophylaxis was then recommended for all residents and unvaccinated staff on Unit E. The day after prophylaxis was begun, a roommate of the Unit E case was confirmed to have influenza A, and another case was confirmed on Unit B. At that time, prophylaxis was recommended for all residents and unvaccinated staff on the second floor. Seven additional suspect cases on the second floor were identified retrospectively. Of these, five had tested negative for influenza by both rapid antigen test and RT-PCR. In total, of 79 residents on the second floor, 10 (13 per cent) confirmed and suspect cases were identified. In total, 95 (97 per cent) of the 98 facility residents received the 2005-2006 influenza vaccine in October 2005 including all confirmed and suspect cases. The vaccines were all of a single lot and were administered by facility nursing staff. The outbreak described in this report occurred despite the fact that 97 per cent of residents in the facility had been vaccinated. While influenza immunization remains the primary mechanism of influenza outbreak prevention in closed living communities such as chronic care facilities, residents remain at risk of infection if influenza is introduced into the facility, especially if the strain of influenza introduced does not match the vaccine strains. Even when the infecting strain matches the vaccine strain, the vaccine may have lower efficacy among residents of chronic care facilities. Children at high risk for complications from influenza infection may also have a lower antibody response to the vaccine. Company assessment: Seriousness assessment: Seriousness criterion: medically significant. Causality: not related, influenza is caused by a viral infection. Expectedness assessment according to product information: Influenza is unexpected after vaccination with BEGRIVAC, FLUAD, AGRIPPAL or FLUVIRIN. Vaccination failure and drug ineffective are expected. On a case level, the case is considered unexpected. No change in benefit-risk-ratio. No measures necessary.									U					OTH	OTH	No other medications	Unknown			MA20083130	1						1	Acute respiratory distress syndrome; Cardiovascular insufficiency; Drug ineffective; Influenza; Influenza like illness; Nervous system disorder; Polymerase chain reaction; Pyrexia; Vaccination failure; Viral infection	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0334886	12/10/2008	PA	56.0	56		M	12/10/2008	Flu vaccine given on 10/1/08 @ 15:00 pm.  Developed sob on exertion & left scapular back pain within 30 minutes of immunization.  Reported symptoms to supervisor @ 9:00pm.  Ambulance called to transport to local ER.				Y					Y	10/01/2008	10/01/2008	0	CBC/diff- increased WBC with slight left shift, chem profile negative.  CPK negative; Troponin negative; EKG no acute ST- T wave changes, diffuse T wave flatening. cxr negative; xepenex & atrovent tx with good respone.	OTH	PVT	HCT; LISIAOPRIL, METOPROPLOL, FEXOFENADINE.	None	ASA	None~ ()~~0.00~In Patient|Unknown~ ()~~0.00~In Sibling		1						1	Back pain; Blood creatine phosphokinase normal; Chest X-ray normal; Differential white blood cell count abnormal; Dyspnoea exertional; Electrocardiogram normal; Laboratory test normal; Musculoskeletal pain; Troponin; White blood cell count increased	FLU3~SANOFI PASTEUR~U2762AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334887	12/10/2008	MA	30.0	30		F	12/10/2008	Autoimmune plexography involving right arm.  Vaccine given in left arm.										11/12/2008	11/14/2008	2		PVT	OTH		TB Adenitis	Allergies to many drugs			1						1	Autoimmune disorder; Nerve injury; Autoimmune disorder	FLU3~SANOFI PASTEUR~U2798EA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2798E~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0334888	12/10/2008	WA	58.0	58		M	12/09/2008	Bilateral breast swelling 4 hrs post vaccination, slowly improving over next 24 hours.									Y	12/08/2008	12/08/2008	0		PVT	PVT			Seasonal allergies; Hx low white count; varicose vein (R) leg; hypercholest.; lactose intolerance.			1						1	Breast swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881135P~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334890	12/10/2008	OR	1.0	1	.0	M	12/10/2008	Varicella rec.'d, 11/10/08, with influenza, Hep A, MMR, IPV vaccinations. G mother reports 9 days later chicken pox with high fever and fine rash. Resolved without intervention.									Y	11/10/2008	11/19/2008	9		PUB	PUB				Same~Varicella (no brand name)~1~1.00~In Sibling		1						1	Pyrexia; Rash; Varicella; Varicella post vaccine	FLU3~SANOFI PASTEUR~U2804AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0996~4~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0665X~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~04222X~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0334894	12/10/2008	GA	6.0	6		F	12/08/2008	Wheezing, SOB, sweating, fever, disoriented, went to ER 12/8/08				Y					Y	12/08/2008	12/08/2008	0		PVT	PUB		None	None			1						1	Disorientation; Dyspnoea; Hyperhidrosis; Pyrexia; Wheezing	FLU3~SANOFI PASTEUR~U2802AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB282AA~2~IM~RA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0334895	12/10/2008	VA	59.0	59		F	12/10/2008	Received phone call from pt. advising got her flu shot yesterday afternoon. Then midnight itched, feeling bad. Then this morning been throwing up and have a severed headache. Advised her to see her private provider for evaluation. Also arm is sore.									U	12/09/2008	12/10/2008	1		PUB	PVT		None	None			1						1	Feeling abnormal; Headache; Pain in extremity; Pruritus; Vomiting	FLU3~SANOFI PASTEUR~U2805AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334896	12/10/2008	MA	43.0	43		F	10/22/2008	Pt c/o soreness at injection site, axilla swollen and red rash.  Red streak 1 wide down arm that spread around to front of arm									Y	10/02/2008	10/03/2008	1		PVT	PUB		No				1						1	Injection site pain; Lymphadenopathy; Rash erythematous; Skin striae	FLU3~SANOFI PASTEUR~U2741AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1132U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0334898	12/10/2008	MA	43.0	43		F	10/22/2008	PNEUMOVAX injection given 10/6/2008 on 10/8/2008 right arm erythematous macular areas of varying sizes, oval shaped max 3cm. No induration of ecchymosis. Lesions not at site of injection.									Y	10/06/2008	10/08/2008	2		PVT	PUB						1						1	Rash erythematous; Rash macular; Skin lesion	FLU3~SANOFI PASTEUR~U2741AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1132U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0334900	12/10/2008	TN	38.0	38		M		(R) deltoid - warm, red - lump - 30 additional small reddened area / 1 near site. Medically deferred permanently from further Anthrax. Will continue to monitor localized reaction.									U	11/17/2008	11/20/2008	3		MIL	OTH						1						1	Erythema; Local reaction; Mass; Skin warm	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TYP~SANOFI PASTEUR~A0923~2~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0334902	12/10/2008	PA	14.0	14		F	12/10/2008	Pt given immunizations getting up to leave felt faint or fainted. Alert and oriented after 15 seconds.									Y	12/10/2008	12/10/2008	0	Vaso Vagal reaction	PVT	PVT	None	None	None			1						1	Dizziness; Syncope; Syncope vasovagal	FLU3~SANOFI PASTEUR~U2742AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~05484~1~UN~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2486AA~1~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0334611	12/11/2008	CA	19.0	19		F	12/09/2008	Previously healthy 19-year old female college freshman found dead in her dorm bed approximately 10 days after receiving GARDASIL and meningitis immunizations over Thanksgiving break while visiting family in her hometown. She had very recently made a doctor appointment for the afternoon of Mon. 12/08/2008- pending at the time of her death. She did not show up for the appointment, was found in her bed in the dorm room dead with rigor mortis. The reason noted by intake clerk at student health for making a medical appointment was possible seizure, patient had no prior medical history of epilepsy or any other disorder, was physically fit and on the crew team. She was last seen alive the evening of 12/7/08. She had talked on the phone to her out-of-state boyfriend and chatted with her dorm roommate. She had complained of a headache and not feeling well that day. She went to bed at 10:30 PM. In the AM, her roommate arose and thought patient was still asleep. The roommate left for the day of classes. Patient did not return friends text messages that day, leading to the finding of her body in bed in the dorm room about 5 PM 12/08/08. Preliminary autopsy done 12/09/08 shows no obvious cause of death per family's verbal report to me. Toxicology results are pending, due back in 6 weeks. Patient had no history of substance abuse and is not thought to be a suicide risk. She had been thriving in college and happy. No suspicions of foul play. Patient was a non-smoker. Funeral is planned for Sat 12/13/08. Tragic end for a brilliant and beautiful young woman. Please investigate possible role of GARDASIL and/or menigococcal vaccine in this death. This report submitted by patient's family friend MD, Internal Medicine and Geriatrics. Thank you for your prompt attention to public safety.	Y	12/08/2008								11/20/2008	12/08/2008	18		UNK	UNK	Patient also reportedly received a meningococcal vaccine at the time of GARDASIL vaccine.					1						2	Autopsy; Death; Headache; Malaise; Autopsy; Death; Headache; Malaise; Death; Dizziness; Headache; Malaise; Nausea	FLUN3~MEDIMMUNE VACCINES, INC.~500569P~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0070X~3~~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2730AA~UNK~~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|HPV4~MERCK & CO. INC.~~UNK~UN~UN~HPV (GARDASIL)~2|MEN~UNKNOWN MANUFACTURER~~UNK~UN~UN~MENINGOCOCCAL (NO BRAND NAME)~2|HPV4~MERCK & CO. INC.~~UNK~UN~UN~HPV (GARDASIL)~3|MEN~UNKNOWN MANUFACTURER~~UNK~UN~UN~MENINGOCOCCAL (NO BRAND NAME)~3	USA	Results in Death	Influenza
0334904	12/11/2008	AZ	4.0	4		M	12/08/2008	This serious case was received from a health professional on 01 December 2008. A 4 year-old male patient, with no known allergies and no reported medical conditions, received the following vaccines on 18 November 2008: a fifth right thigh injection of DAPTACEL (lot number C3000AA); a fourth left thigh injection of IPOL (lot number A1109); an injection of MMR II (Merck, lot number 1250X); an injection of VARIVAX (Merck, lot number 1009X); and nasal FLUMIST (MedImmune, lot number 500545P). Five minutes after vaccination, the patient began sneezing and vomiting, and experienced shortness of breath. He was given epinephrine in the office, and then sent to the emergency room for observation. He was released the same day; outcome was unknown. The reporter for this case also reported a similar event in another 4-year-old patient; this event is captured in case number 2008-03836. Documents held by sender: None.				Y					U	11/18/2008	11/18/2008	0		PVT	OTH			No known allergies, no medical conditions.		200803837	1						1	Dyspnoea; Immediate post-injection reaction; Sneezing; Vomiting	DTAP~SANOFI PASTEUR~C3000A~5~UN~RL~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~505545P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~A1109~4~UN~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1250X~5~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1009X~UNK~UN~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0334933	12/11/2008	CA	5.0	5		M	12/06/2008	Child was given IM Flu vaccination in pediatrician office. Site of injection - right vastus lateralis. Within 12 hrs pt. presented at site of injection erythema, edema/inflammation, localized pain, and low-grade fever - 99. Within 36 hours - symptoms had diffused to about 70% of right thigh. Child was taken to an Urgent Care center - dx with cellulitis; given sulfamethoxazole and trimethoprim.									U	12/04/2008	12/04/2008	0		UNK	UNK			Otherwise healthy five-year-old child who had not been previously ill within the last eight months - last infection being otitis media. No hospitalization or major illness.			1						1	Cellulitis; Injection site erythema; Injection site inflammation; Injection site oedema; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0334935	12/11/2008	TX	17.0	17		F	12/04/2008	After nurse gave FLUMIST and GARDIASIL, pt's face went blank and pt head deviated to the right, also pt's arms went stiff in extension; hands shook a little, legs extended also & loss of urine onto floor, lasted 30-60 seconds, pt was tired and nauseous afterward. No vomiting.									Y	11/25/2008	11/25/2008	0	None	PVT	PVT	None Known	None	Syncope 1/19/07			1						1	Fatigue; Musculoskeletal stiffness; Nausea; Posture abnormal; Tremor; Urinary incontinence	FLUN3~MEDIMMUNE VACCINES, INC.~500585P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0070X~1~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0334936	12/11/2008	AZ	56.0	56		M	11/26/2008	Bilateral conjunctivitis, sore throat, non productive cough. chest tightness, slight wheezes, swelling around eyes and body aches. BENADRYL 25mg times one per day, Ibuprofen 200mg times twice per day, no effect.									Y	11/25/2008	11/25/2008	0		OTH	UNK		None	None			1						1	Chest discomfort; Conjunctivitis; Cough; Eye swelling; Oropharyngeal pain; Pain; Wheezing	FLU3~SANOFI PASTEUR~U2831AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334938	12/11/2008	NC	4.0	4		M	12/08/2008	Mother reported patient had hives/itching about 2hrs. after vaccine administered. Gave 1 tsp of Benadryl with good results. Next day only small area of hives- no itching.									Y	11/13/2008	11/13/2008	0	None	PVT	PVT	Singulair; Flovent; Prevacid	None	Asthma			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2811AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334940	12/11/2008	NC	47.0	47		F	12/05/2008	Patient complaint - pain left shoulder. MD visits - no signs of swelling, erythema. Tenderness. Pain noted with passive abduction, limited active internal rotation. Diagnosis bursitis secondary to flu vaccination treated with KENALOG injection into sub deltoid bursa.				Y					Y	10/16/2008	11/18/2008	33	X-rays showed no abnormalities	UNK	PVT	Vitamins reported	Unknown	Unknown			1						1	Bursitis; Dyskinesia; Musculoskeletal pain; Vaccination complication; X-ray normal	FLU3~SANOFI PASTEUR~U2753AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0334942	12/11/2008	PA	0.6	0	.6	M	12/04/2008	Seemed himself all day. Got home at 5:30 pm. Crying was different, shaking for probably 5 minutes. Seemed like he was in pain. Good eye contact. Fell asleep on car ride home, more snuggly tonight. Appetite good, no vomiting. Was given TYLENOL 0.8 ml at 1pm.									Y	12/04/2008	12/04/2008	0		PVT	PUB						1						1	Crying; Pain; Tremor	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B167AA~UNK~UN~UN~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2811AA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~4F520AA~3~UN~UN~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C71571~3~UN~UN~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0898X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0334944	12/11/2008	CT	12.0	12		F		Within one week of immunizations patient developed hip arthralgia, in (R) hip then both, crutches, seen 11/25/08 1st. Referred to Rheumatology at Med. Ctr.  1/21/09 Received Rheumatology clinic records of 12/3/08 FINAL DX: probable conversion reaction Records reveal patient had right hip pain x 3 weeks.  Seen by PCP & in ER for pain.  X-rays were WNL.  Now w/bilateral hip pain & unable to walk w/o crutches.  Sleep was disturbed.  Morning stiffness.  NSAIDS had not helped.  tx w/meds & PT				Y					N	10/29/2008			X-ray; Ultrasound Hips; WBC; CBC; WMC (WBC 7.2), ESR 7, CK 95; Lyme, neg; RA factor, neg, ANA, neg  LABS: hip US WNL.  CBC, ESR, CK, ANA, RA, CRP all WNL.	PUB	PUB	None		None			1						1	Antinuclear antibody negative; Borrelia burgdorferi serology negative; Red blood cell sedimentation rate normal; Rheumatoid factor negative	FLU3~SANOFI PASTEUR~U2769AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB259AA~1~IM~UN~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~1487U~3~IM~UN~HPV (GARDASIL)~1|VARCEL~MERCK & CO. INC.~1185X~2~SC~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0334945	12/11/2008	CT	1.31	1	.3	M	12/04/2008	Child with hive like rash. Started on leg, flu injection was given in and now spread over the rest of child's body.									N	12/03/2008	12/04/2008	1	No	PVT	PVT	None	No	No			1						1	Rash generalised; Urticaria	DTAP~SANOFI PASTEUR~C3081AA~4~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2787CA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0334946	12/11/2008	KY	0.5	0	.5	F	12/03/2008	Pt given HIB, PREVNAR, PEDIANX, ROTATEQ, influenza @ 13:35.  At 13:46 someone in waiting room said, that baby's face doesn't look right.  Went to waiting room.  Mom holding infant, infant crying, hives noted on entire face and head.  Mom carried baby to exam room.  Trunks rash; hands, arms, legs, feet bilat right swollen.  Adv mom on potential  reaction.  Infant given 0.1cc BENADRY im @ 13:47.  LP-120 crying no wheezing.  13:53 R-45 hives on forehead only, blow by O2 admin. @ 13:49 P-148, hives on forehead, crying, no wheezing.  EMS arrival 13:52.  Pt to ER via EMS @ 13:55 with mom carrying infant.				Y					U	12/03/2008	12/03/2008	0	None	PUB	PUB	None	None	None			1						1	Crying; Rash generalised; Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC21B167AA~3~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~42839AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF513AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C87338~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0593X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0335042	12/11/2008	VA	38.0	38		F	12/11/2008	Received FluMist @ 9:45 am 12/10/08. One hour later c/o dizziness, sore throat, throat swelling, hoarseness, cough. No SOB/resp distress. She went to ER where dx with allergic reaction. Given pred, epi pen, benadryl, claritin w/relief of s/s.				Y					Y	12/10/2008	12/10/2008	0	none	MIL	MIL	none	none	none			1						1	Cough; Dizziness; Dysphonia; Hypersensitivity; Oropharyngeal pain; Pharyngeal oedema	FLUN3~MEDIMMUNE VACCINES, INC.~50056P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0335043	12/11/2008	WA	53.0	53		M	12/11/2008	Approx 16 hours after vaccination patient began experiencing aching joints and muscle pain approx 20 hours after vaccination he began getting a fever - fever reached 102.7.  Approx 40 hours after vaccination fever would not go down took him to minor emergency where they kept him for 4 hours giving him an iv to re-hydrate him and got fever down to 100.3 and sent us home.  Upon arriving home fever increased again to 102.4.  At approx 52 hours after vaccination fever began to break.  Patient spent 5 days in bed, missing 3 days of work.  Could not eat for 4 1/2 days of this.				Y					Y	11/21/2008	11/22/2008	1	Physician stated probably a reaction to the shot as he exibited flu like symptoms, however probably not allergy to shot as no hives.	UNK	UNK	LEVOTHYROXIN 112 MCG TAB MYLA	None	None	none~ ()~~0.00~Patient|none~ ()~~0.00~Sibling|none~ ()~~0.00~Sibling		1						1	Activities of daily living impaired; Anorexia; Arthralgia; Myalgia; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA183AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0335046	12/11/2008	UT	47.0	47		F	12/11/2008	24 hours after receiving Yellow fever vaccine, Pnuemovax and Influenza pt reports severe migraine headache and considerable body/joint pain with low grade fever. Took Acetaminophen for pain relief. 36 hours after Vaccination patient reports she is feeling almost back to normal									Y	12/09/2008	12/10/2008	1		PVT	PVT	OTC vitamins	None	None	severe body aches/fever~Yellow fever (no brand name)~1~~In Sibling1		1						1	Arthralgia; Migraine; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA374AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0980X~1~IM~LA~PNEUMO (PNEUMOVAX)~1|YF~SANOFI PASTEUR~UF315AA~1~SC~RA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0335047	12/11/2008	SD	5.0	5		F	11/20/2008	Firm, warm, raised area at injection site.  Ice, Benadryl.				Y					Y	11/14/2008	11/16/2008	2		PVT	PUB	Triaminic					1						1	Injection site induration; Injection site swelling; Injection site warmth	DTAP~SANOFI PASTEUR~U2470AA~5~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2811AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~942440~4~SC~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0908x~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0989x~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0335049	12/11/2008	SD	3.0	3		F	11/19/2008	Flu vaccine wrong age group give.									Y	11/18/2008				PVT	UNK						1						1	Inappropriate schedule of drug administration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89983~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0335053	12/11/2008	OR	60.0	60		F	12/11/2008	Progressive weakness, numbness/tingling in arms & legs with back pain beginning 11/10/08. ED visit followed by hospital admission (Dx - Guillain Barre syndrome following influenza and pneumococcal vaccinations) on 11/20 after pt fell at home.  Pt currently in ICU on ventilator since 11/21 being treated with IVIG 42g IV daily.  2/2/09 MR received for DOS 11/21/08-1/9/09 with D/C DX:  Guillain-Barre Syndrome requiring ventilator support, sh is currently weaning off the ventilator. Pt presented with 4-5 day hx of fever, tingling of hands and feet with subsequent weakness, nausea and vomiting, and difficulty with ambulation. Recent sinus sx tx with abx. PE (+) for areflexia, decreased muscle strength. Neuro consult Impression GBS, probably post vaccinial. Developed progressive weakness and respiratory failure requiring intubation.  Tx with IVIG with no significant improvement. Trach and PEG tubes placed. Had possible seizure with (-) EEG. UTI tx with abx.  Autonomic instability with HTN and bradycardia. Developed a sacral decubitus ulcer. Brief episode of atrial fib on 1/5/09. In January able to begin weaning from vent.  Transferred for further rehab. 02/01/2010 Follow-up: Neurology consult 7/22/09-Residuall numbness and tingling in both legs, right>left. Numbness and tingling in her hands and weakness. Right foot drop and facial tenderness with difficulty chewing and masticating. Altered taste and decreased appetite. Residual numbness around her mouth as well.			Y	Y	Y	41			N	11/05/2008	11/10/2008	5	MRI, LP. Labs and Diagnostics:  MRI LS, thoracic spine (+) degenerative changes. CT head (-).  CK 357-558. CKMB (-). Troponin I 0.03-0.09.  WBC increased.  CSF cell count WNL.  CSF protein 155.  CSF glucose 104. CSF cx (-). CXR (+) infiltrate. EKGs abnormal. EEG WNL.	UNK	UNK	Reg Insulin - sliding scale   Lisinopril 40 mg po daily   Lorazepam 0.5 mg po tid   Metoprolol 100 mg po bid   Omeprazole 20 mg po bid	sinusitis - amox/clav tx	PAST MEDICAL HISTORY 1.  Type 2 diabetes mellitus.   2.  Obesity - BMI > 30.   3.  Hypertension. 4.  Hypercholesterolemia.   5.  Osteoarthritis in the left knee. 6.  Gastroesophageal reflux disease.   7.  History of depression.   8.  Coronary artery disease - S/P MI in 04/96. Angioplasty to an obtuse marginal. Angioplasty mid LAD 1997 and angioplasty proximal LAD 1989 and 1990. Cardiac cath 01/06 - normal vessels except 40 to 50% RCA stenosis.  PMH: Type 2 DM. Obesity.HTN. Hypercholerolemia. Osteoarthritis.  GERD. depression. CAD. MI. Angioplasty. Allergy to propxyphene. Recent sinus sx.			1						1	Back pain; Blood product transfusion; Decreased appetite; Dysgeusia; Electrocardiogram normal; Fall; Guillain-Barre syndrome; Hypoaesthesia; Hypoaesthesia oral; Intensive care; Lumbar puncture; Mastication disorder; Mechanical ventilation; Muscular weakness; Nuclear magnetic resonance imaging; Paraesthesia; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881176P~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0619X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0335054	12/11/2008	RI	47.0	46		F	12/11/2008	Fever of 102, violent chills and body shakes, extreme headache, body aches.										12/09/2008	12/09/2008	0		PUB	UNK		No	No			1						1	Chills; Headache; Pain; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0335060	12/11/2008	NY	59.0	59		M	12/11/2008	Influenza vaccine administered on 10/29/08.  Pt developed severe posterior left arm/shoulder pain the evening of 11/1/08, followed by left arm numbness and left hand tingling on 11/2/08.  Pt seen by N.P. on 11/3/08. Prescribed Flexeril and Ibuprofen.  F/U on 11/7 resulted in referral to a neurologist. Delay in this reporting is based on pt. being ruled out for presence of possible tumors in left arm. Neurologist diagnosed pt as having mild left brachial plexopathy. Tx: Prednisone 100mg tapering every 3 days by 20mg, Physical Therapy 2-3times per week/with Neuro Muscular Stimulation along with strength exercises for 6 weeks.				Y					N	10/29/2008	11/01/2008	3	MRI performed/tumor was ruled out. Sedimentation rate and Lyme titer were also drawn. Results unknown.  Nerve conduction/EMG testing showed: evidence of acute denervation by EMG with absent sensory response from the left Medial antebrachial cutaneous nerve consistent with an early Brachial Plexopathy.  No evidence of pronator stress syndrome.  There is evidence of mild bilateral Median and Ulnar nerve abnormalites consistent with compressive neuropathies.  These are probably due to a chronic overuse syndrome.	PUB	PVT	none	none	No diagnosed allergies.Denies birth defects.  Has borderline hypertension.			1						1	Borrelia burgdorferi serology; Brachial plexopathy; Electromyogram abnormal; Hypoaesthesia; Musculoskeletal pain; Nerve conduction studies abnormal; Pain in extremity; Paraesthesia; Red blood cell sedimentation rate; Repetitive strain injury	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU364BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0335062	12/11/2008	NJ	10.0	10		M	12/11/2008	Quarter sized lump and redness with approximately six small itchy welts around injection site.									Y	12/10/2008	12/11/2008	1	None	PVT	PVT		None noted	None noted			1						1	Injection site erythema; Injection site mass; Injection site pruritus; Injection site urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500583P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~1155X~2~IM~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0335064	12/11/2008	MN	11.0	11		F	12/11/2008	3 days after nasal administration of vaccine, patient developed persistent fever to 103.7, myalgias, nasal congestion, anorexia, fatigue.  So far, this has lasted for 4 days.									U	12/05/2008	12/08/2008	3	None at this time	UNK	PVT	none	none	none			1						1	Anorexia; Fatigue; Myalgia; Nasal congestion; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~66019-0106-01~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335065	12/11/2008	OH	0.63	0	.6	M	12/11/2008	Per mother, patient became unconsolable,refused to eat within 24 hr. after the vaccine. No report of an elevated temperature. This continued for over 24 hr.,for which patient was refered to the ER for further evaluation.Resolved within 48 hrs.				Y					Y	12/01/2008	12/01/2008	0	None	PVT	PUB		Eczema	Club foot			1						1	Diet refusal; Irritability	DTAP~SANOFI PASTEUR~U2478CA~3~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2783CA~4~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1000F~3~IM~LL~HEP B (RECOMBIVAX HB)~1|HIBV~SANOFI PASTEUR~UF345AB~3~IM~LL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~A0474-2~3~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~C40031~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0395X~2~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0335066	12/11/2008	PA	39.0			M	12/11/2008	3 hours or so after injection, under my tongue and lips started to swell, my eyes became VERY bloodshot and runny (goopy might be a better word for it), my throat began to constrict slightly (enough where I noticed it), and I became lethargic. I took Benadryl and these initial symptoms subsided. Later that evening, I felt like I had the full-blown flu: I had no energy, 102-degree fever, and chills. These symptoms lasted to a lesser degree for another day and a half. No treatment was undergone, beyond the initial Benedryl.									Y				I was subsequently tested for an egg allergy (which I already knew I didn't have), which came back negative.	PVT	UNK	Multivitamin	none	None	same as above~Influenza (Seasonal) (no brand name)~UN~35.50~In Patient		1						1	Allergy test negative; Asthenia; Chills; Eye discharge; Influenza; Lethargy; Lip swelling; Ocular hyperaemia; Pyrexia; Swollen tongue; Throat tightness	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0335067	12/11/2008	CA	54.0	54		F	12/11/2008	This is the third year I have had the influenza vaccine. Every year I go to a walk in clinic locally to obtain the injection.  Today is day 8 or 9 after my vaccine and I am having the exact symptoms as I had two years prior.  I am a Registered Nurse (retired) so I know now that this thrd time is not by coincidence.  I feel like I am dying.  I have a low grade fever everyday that starts at about 11 a.m., my entire body aches and I am fatigued...I literally feel like I am dying.  Last night my airway became obstructed minimally and I could not catch my breath.  I feel nauseated and I can barely eat.  Every doctor and nurse I speak with essentilly thinks I am wrong and that I have the flu...I know this is not true.  I am a healthy lady and I ride a horse and work in the community daily.  I am really sick from the vaccine and I will never take it again if I survive this round of symptomology										12/05/2008	12/07/2008	2	no labs	PUB	PVT	synthroid, atenolol	none	none			1						1	Decreased appetite; Dyspnoea; Fatigue; Malaise; Nausea; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0335070	12/11/2008	OR	73.0	73		M	12/11/2008	10/23/08- runny nose.  10/25/08- sore throat.  10/26 to 30- fever, felt sick, sneezing.  11/1/08- diarrhea.  11/5/08 vomiting, seen at emergency room.   11/15/8- diarrhea. 11/17-20 still sick.  11/24- finally better.				Y					Y	10/20/2008	10/23/2008	3		PVT	UNK		fatigue	paxil, vioxx, relafen			1						1	Diarrhoea; Malaise; Oropharyngeal pain; Pyrexia; Rhinorrhoea; Sneezing; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8803906~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0335089	12/11/2008	MO	4.0	4		M	12/11/2008	Administration of vaccines was non combative. Approx 20min after vaccines, patient stated his nose was hurting. Mom states he was in a lot of pain. Several minutes later, he vomited. No rash, swelling, difficulty breathing, further vomiting occurred. Had diarrhea on 12/11/08.									Y	12/09/2008	12/09/2008	0	None	PVT	PVT	None	None				1						1	Diarrhoea; Rhinalgia; Vomiting	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B103AC~1~UN~RL~DTAP + IPV (KINRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500585P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~MERCK & CO. INC.~1365X~2~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0996X~2~UN~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0335090	12/11/2008	MA	57.0	57		F	11/28/2008	Pt reports localized hard swelling @ injection site (left deltoid).  Pt reports sl tingling down arm and itchy arm.  Reports s/s lasted 3 days.									Y	11/18/2008	11/18/2008	0	Did not go to doctor's office (reports she is between doctors @ this time).	PUB	PUB		Denies	Denies		MA0812	1						1	Injection site induration; Injection site swelling; Paraesthesia; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA191AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1679U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0335092	12/11/2008	TX	63.0	63		F	12/09/2008	Sore arm that patient claimed to be immobile the next day after receiving 2 shots. Shoulder was swollen.									Y	12/04/2008	12/05/2008	1		OTH	PVT						1						1	Injected limb mobility decreased; Joint swelling; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89985~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~08678~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0335093	12/11/2008	WA	6.0	6		F	11/06/2008	Fine papular rash covering entire trunk and arms, itchy									Y	10/22/2008	10/23/2008	1	None	PUB	UNK	None	None	None			1						1	Pruritus; Rash; Rash papular	FLU3~SANOFI PASTEUR~U2808AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335095	12/11/2008	CA	0.6	0	.6	F	12/11/2008	After vaccination, mother noted baby to have arching of back/ no seizure activity and swelling of cheek/face area and trouble breathing. Symptoms all resolved - vitals and exam were normal except some mottling of skin. POX = 100% RA. HR = 128. RR = 38. Stable, but sent to ER for further evaluation and observation.				Y					Y	12/11/2008	12/11/2008	0	None in clinic	OTH	PUB	ORAJEL	None	Hemangioma on buttocks; prematurity			1						1	Dyspnoea; Livedo reticularis; Opisthotonus; Swelling face	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B156EA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U72785AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UE369AA~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C83143~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0301X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0335101	12/11/2008	MN	13.0	13		F	12/11/2008	LOC after vaccine administered. Caught  by MA pt did not hit head. Brought to exam table and leveled pt lupine LOC about 30 seconds total. After 30 seconds pt responsive, pale. BP=100/62; P=68 states never fainted with vaccine previously.									Y	11/24/2008	11/24/2008	0	None	OTH	PUB	None	None	None			1						1	Fall; Immediate post-injection reaction; Loss of consciousness; Pallor	FLU3~SANOFI PASTEUR~42848AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0072X~1~IM~LA~HPV (GARDASIL)~1|MMR~MERCK & CO. INC.~02824~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0335102	12/11/2008	ME	33.0	33		F	12/11/2008	Pt. came in to see me -  presented with (L) arm redness, tenderness, warmth, palpation - was hard to touch. Instructed ice, ibuprofen, BENADRYL - call with worsening.									U	12/11/2008	12/11/2008	0	None	PVT	PVT		None				1						1	Erythema; Induration; Skin warm; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89738~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0868X~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1|TTOX~SANOFI PASTEUR~U2024AA~UNK~UN~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0335107	12/11/2008	NY	10.0	10		M	12/11/2008	Red circle around injection site - advised to apply cool compress and Motrin prn.									U	12/04/2008	12/08/2008	4	None	PVT	PVT	None	None	None			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U2731AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1010X~2~IM~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0330598	12/12/2008	ND	43.0	43		U	10/29/2008	17 Oct 08, pt. developed acute onset of substernal chest pressure at rest. Pressure became a sharp pain that worsened with deep breathing and also radiated down the left arm.									U	10/07/2008	10/13/2008	6	Pt's symptoms and EKG findings are most C/W mild pericarditis and a viral syndrome, most likely as a result of the smallpox vaccine. We will get an echocardiogram to assess for a pericardial effusion and to ensure cardiac function is normal.	MIL	MIL		None	None			1						2	Chest discomfort; Chest pain; Echocardiogram; Electrocardiogram abnormal; Pericarditis; Vaccination complication; Viral infection; Chest discomfort; Chest pain; Electrocardiogram abnormal; Pericarditis; Vaccination complication; Viral infection	ANTH~EMERGENT BIOSOLUTIONS~FAV174~2~SC~UN~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500549A~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB596CA~3~IM~UN~HEP B (ENGERIX-B)~1|SMALL~EMERGENT BIOSOLUTIONS~UNK~3~ID~LA~SMALLPOX (ACAM2000)~1|TYP~SANOFI PASTEUR~A09233~7+~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|ANTH~EMERGENT BIOSOLUTIONS~~UNK~UN~UN~ANTHRAX (BIOTHRAX)~2|FLUN3~MEDIMMUNE VACCINES, INC.~500549A~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB8596CA~UNK~UN~UN~HEP B (ENGERIX-B)~2|SMALL~EMERGENT BIOSOLUTIONS~ACAM2000~UNK~ID~UN~SMALLPOX (ACAM2000)~2|TYP~SANOFI PASTEUR~A09233~UNK~UN~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~2	USA		Influenza
0332326	12/12/2008	FL	55.0	55		U		Immunization given 11/13/2008 11:30 AM complained of nausea, coughing, chest tightness, sweaty blurry vision.									Y	11/13/2008	11/13/2008	0		UNK	UNK		None	Fish, Milk			1						2	Chest discomfort; Cough; Hyperhidrosis; Nausea; Vision blurred; Chest discomfort; Cough; Hyperhidrosis; Nausea; Vision blurred; Blood test; Chest pain; Cough; Dysphonia; Dyspnoea; Eye discharge; Eye swelling; Hypersensitivity; Lethargy; Ocular hyperaemia; Upper respiratory tract congestion; X-ray	FLU3~SANOFI PASTEUR~U2831AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2831AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA		Influenza
0335122	12/12/2008	WV	59.0	59		M	12/09/2008	Please see accompanied occurrence report form. Pt spouse phoned in this am to state that pt had an adverse reaction to the imm. received on 11/26/08. She stated that she was concerned as he had received  FLUZONE and PNEUMOVAX in the same arm (L). Upon review of pt. record these two imm. were given in separate arms. She states that pt. had swelling and redness from the elbow to the shoulder and that the area was hot to touch. She states that she gave him Benadryl and that she was concerned as the patient had lost mobility to the affected arm for 3 days. The patient did not seek medical attention. When I offered an appt. for eval. of the arm she refused stating that the patient was better. She stated that she was concerned because the FLUZONE and PNEUMOVAX shots were given in the same arm and shouldn't have. I encouraged her that I appreciated her concern and that I planned to speak with the nurse, the physician involved as well as Administration to let them know of the incident. I also encouraged her that we would discuss this issue at our next nurse meeting and that maybe a better thing to do in the future is to request for the pt. to come back in a week for the 3rd imm. injection (Patient had BOOSTRIX , PNEUMOVAX AND FLUZONE shot ordered on 11/26/08). She thanked me for my time and I also told her that I would additionally contact VAERS to see if anything additionally needed to be done 12/5 Adverse reaction state # contacted. 12/9/08 VAERS form completed and mailed.									Y	11/26/2008	11/27/2008	1		PVT	OTH		None Known				1						1	Erythema; Injected limb mobility decreased; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U2849AC~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0803U~1~UN~RA~PNEUMO (PNEUMOVAX)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~C3030AA~1~UN~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0335123	12/12/2008	NJ	38.0	38		F	11/26/2008	Chills, sweats, aches & pains in arms & legs.									Y	11/25/2008	11/25/2008	0	Hospital took vitals - said OK	PUB	PUB	Lipitor; Abilify; vitamins; birth control	No	Cipro			1						1	Chills; Hyperhidrosis; Pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2853AB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335132	12/12/2008	CA		49		F	12/06/2008	The vaccine was given in my left deltoid, within a couple hours my under arm / lymph node (same arm) started getting very sore. By AM,  I noticed a lump under my arm. Also one behind left ear, and my neck was stiff and sore. These symptoms have lasted quite awhile.									U	11/24/2008	11/24/2008	0	Mamogram to be done on 12/05/08	OTH	OTH						1						1	Lymph node pain; Mammogram; Mass; Musculoskeletal stiffness; Neck pain	FLU3~SANOFI PASTEUR~U2759AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335133	12/12/2008	WA	4.0	4		F	12/05/2008	Within 5 mins of vaccine red spots around eyes, some redness by DTAP, influenza vaccine locations (sites). Given 25mg PO Benadryl. Seen by MD.									Y	12/05/2008	12/05/2008	0	Physical exam; strep test negative result; cellulitis	PVT	PUB	None	None	None			1						1	Immediate post-injection reaction; Injection site erythema; Ocular hyperaemia	DTAP~SANOFI PASTEUR~C2956AA~5~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2829AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0891X~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1007X~2~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0335134	12/12/2008	MA	27.0	27		F	12/08/2008	Vaccine given at 2:30 pm, by 6:30 pm experience numbness of face, swollen lips, rapid heartbeat, throat narrowing, wheezing at ER-given EPINEPHRINE, SOLUMEDROL, 20 FRAN, ALBUTEROL, BENADRYL, PEPCID, 40 mg PREDNISONE X 3 days				Y					Y	11/03/2008	11/03/2008	0	None	OTH	OTH	None	None	latex			1						1	Heart rate increased; Hypoaesthesia facial; Lip swelling; Throat tightness; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA176AA~1~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0335147	12/12/2008		32.0	32		M	11/17/2008	Itchy all over - diffuse hives on both extremities and upper torso.				Y					Y	11/17/2008	11/17/2008	0	None	MIL	MIL	None	None	None			1						1	Pruritus generalised; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500557P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0335177	12/12/2008	NJ	74.0	74		M	09/24/2008	This case was received from a consumer on 05 November 2007. A 74-year-old male patient, with a history of heart valve replacement and elevated cholesterol, received an intramuscular left deltoid injection of Fluzone (lot number not reported) on 19 October 2007. The injection was administered in the morning, and by evening the patient was experiencing a red raised rash at the injection site, as well as muscular and joint pain in the left arm. On 24 October 2007 he was seen by his physician, who diagnosed shingles and prescribed a 7-day course of famiclovir. He was also seen by an acupuncturist, and the consumer reported that the pain was subsequently relieved. In the days following vaccination he also experienced intermittent swelling in the left hand and bilateral ankles, which was relieved by elevation. Per the reporter, the patient had also been experiencing fatigue and stress. The events had not yet recovered. Follow-up information received on 07 January 2008 from a health care professional. FLUZONE, lot number U2478BA, was administered on 15 October 2007 (previously reported as 19 October 2007). The adverse event onset date was 15 October 2007 (previously reported as 19 October 2007). Per the reporter, the patient recovered from the event.				Y					Y	10/15/2007	10/16/2007	1		PVT	OTH	Coumadin; Lipitor		St Jude valve, increased cholesterol. Patient had no illness at the time of vaccination.		200703739	1						1	Arthralgia; Fatigue; Injection site erythema; Injection site rash; Joint swelling; Myalgia; Oedema peripheral; Stress	FLU3~SANOFI PASTEUR~U2478B~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335180	12/12/2008	NV	19.0	19		F	11/16/2007	This report was received from a health professional on 14 November 2007. A 19-year-old female patient, with a history of diabetes, received an intramuscular left deltoid injection of FLUZONE (lot number U2441AA) on 17 October 2007. That evening, she developed red blotches at the injection site. She also became sleepy and subsequently slept for 10 hours, which the reporter stated was abnormal for her. The following day, the patient complained of nausea and fatigue. The nausea resolved on 18 October 2007, and the fatigue continued for an additional 24 hours.									Y	10/17/2007	10/17/2007	0		OTH	OTH			History of diabetes. No illness at time of vaccination.		200703890	1						1	Fatigue; Injection site erythema; Nausea; Somnolence	FLU3~SANOFI PASTEUR~U2441A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335200	12/12/2008	NJ	56.0	56		M	01/11/2008	Initial report received on 12 November 2007 from a health care professional. A 56-year-old male patient, with no illness at the time of vaccination, had received a left deltoid, intramuscular injection of FLUZONE No Preservative 2007-2008, lot number U2457DA, on 30 October 2007. The patient had received more than six previous doses of influenza vaccine. Two days post-vaccination, the patient experienced body aches, headache, swollen glands on the left side of his neck, sore throat, fluid in his left ear, and inability to sleep. He was examined by a physician and treated with unspecified oral medication. At the time of this report, the patient had not recovered. Follow-up information received on 09 January 2008. Diagnostic testing was done, and the diagnosis was unknown. The patient recovered.				Y					Y	10/30/2007	11/01/2007	2		UNK	PVT			The patient had no past medical conditions and no illness at the time of vaccination.		200703864	1						1	Diagnostic procedure; Headache; Insomnia; Lymphadenopathy; Middle ear effusion; Oropharyngeal pain; Pain	FLU3~SANOFI PASTEUR~U2457D~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335205	12/12/2008	NJ	8.0	8		M	12/12/2008	Patient got a low grade fever exactly two weeks from the vaccine and then he started to develop joint pain. He got severe migratory arthritis in his lower joints and it moved from knees, hips and right ankle depending on the day. He could not walk at all for over a week and we had to take him to the ER, several specialists and my husband had to carry him around the house because he could not walk from the severe pain. We had to use a wheelchair to get him to the doctor's offices and this was all happening to a very healthy 8 year old boy who had never had any joint pain before. He was taken to the ER, took motrin, tylenol which did not help his pain at all. He threw up from the naprosyn liquid but he was finally able to take naprosyn tablets with prevacid and he could get relief from the pain. He also started to get frequent urination and was tested for diabetes and bacterial infection. Everything came back normal. He was tested for RA, strep, CBC and a battery of blood tests and every single test was normal. He also had x rays of all the affected joints and they came back normal. He had pinkish cast to his eyes during the height of the pain and he also had slight swelling of his right knee throughout the migratory arthritis. After 2-3 weeks, he improved and he was able to stop the pain medicine. Two doctors confirmed that this was due to a reaction to the flu shot and we are never getting one again. We have heard of several other similar severe reactions to this flu shot this year. Patient has had flu shots every year since he was 2 years old and he has never had such a reaction, ever! Something is up with the vaccine this year. Too many people are getting bad reactions to it!				Y					Y	09/29/2008	10/13/2008	14	CBC, ESR Westergren, Anachoice SCr, w regl IFA, Rheumatoid factor, ASO AB, Lyme disease ab w/rfx, x-rays of hips, knees, and ankle.	UNK	UNK	Pepcid AC	No illness at time of vaccination	No allergies.			1						1	Abasia; Antinuclear antibody negative; Arthralgia; Arthritis; Borrelia burgdorferi serology negative; Full blood count normal; Joint swelling; Ocular hyperaemia; Pollakiuria; Pyrexia; Red blood cell sedimentation rate normal; Rheumatoid factor; Streptococcal identification test; Vomiting; Wheelchair user; X-ray	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~don't know~UNK~ID~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0335206	12/12/2008	PA	55.0	55		M	12/12/2008	Client received Flu vaccine on 10/17/2008. He had some tenderness at site after injection, but it went away. Approximately 1 week after the injection he developed a sharp pain in the back of his left upper arm only  when he stretches his arm to put his coat on. Denies pain at any other time. He had been raking leaves and does physical labor at work.He had not taken anything for the pain and had not seen his Doctor.Client was advised to take Tylenol or Advil and notify MD.									N	10/17/2008	10/24/2008	7		UNK	PVT						1						1	Injection site pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88805~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0335212	12/12/2008	OR	35.0	35		M	12/12/2008	Vomiting, chills, body ache, fever, headache About 6 hours after getting the Tdap and the inactivated flu vaccine, I experienced nausea and headache and chills. About two hours after that vomiting occurred. Fever and headache are still present 16 hours later.									U	12/11/2008	12/11/2008	0	None	UNK	UNK	None	None	None			1						1	Chills; Headache; Nausea; Pain; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~???~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TDAP~UNKNOWN MANUFACTURER~???~UNK~IM~LA~TDAP (NO BRAND NAME)~1	USA		Influenza
0335216	12/12/2008	TX	14.0	14		F	12/12/2008	PT RECEIVED FLU MIST, MENINGITIS, TDAP, AND HPV VACCINES ON 12/05/08.  ON 12/10/08 DEVELOPED FEVER, STOMACHACHE AND WENT TO EMER RM.  PREGNANCY DIAGNOSED @ 8-12 WKS GESTATION.  LMP WAS 30 DAYS PRIOR TO VACCINATIONS.				Y					U	12/05/2008	12/10/2008	5		UNK	UNK	NONE KNOWN	NONE NOTED	NONE STATED			1						1	Abdominal pain upper; Drug exposure during pregnancy; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0381X~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2683AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B030AA~1~IM~RA~TDAP (BOOSTRIX)~1	USA	Emergency room visit	Influenza
0335217	12/12/2008	MD	9.0	9		M	12/12/2008	<1hr after receiving influenza vaccine SQ, pt developed fullness in throat a/w HA, intermittent dizziness, puffiness to face/eyes, lasting ~1 hour; pt seen in Pediatric clinic within 1/2 hr of onset of symptoms and received PO benadryl 25mg, though had had improvement in symptoms prior to dosing, pt is a known atopic pt with asthma/allergic rhinitis an dprior anaphylactoid reactions to shellfish and systemic allergic reactions to peanuts, bees and papaya; pt was never manifesting of hemodynamic instability, nor respiratory distress				Y					Y	12/12/2008	12/12/2008	0	negative orthostatic CV measurements in clinic, nl POx	MIL	MIL	Flovent, Albuterol, Flonase, Singulair, Zyrtec	none	Allergy - peanuts/shellfish/bees/papaya/multiple environmental; Asthma; Allergic Rhinitis	anaphylactoid~Influenza (Seasonal) (no brand name)~UN~~In Sibling1		1						1	Diagnostic procedure; Dizziness; Eye swelling; Headache; Oxygen saturation normal; Swelling face; Throat tightness	FLU3~SANOFI PASTEUR~U2847AA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335220	12/12/2008	WI	74.0	74		F	12/12/2008	Patient came in to clinic with a reaction to the tetanus shot.  Received Td immunization at this clinic 12/04/08 and on 12/11, patient noted that site became red, swollen and hot. Writer Noted large area (approximately 5cm wide by 7cm long) of erythemic patch, slightly raised, on L deltoid. Very hot to touch with one small streak going from top of erythemic patch in cephalic direction. Erythemic patch did not blanche. No adenopathy of L axilla noted. Sent to urgent care for evaluation and further treatment not available at these clinics.				Y					U	12/04/2008	12/11/2008	7		UNK	UNK	Hyzaar	None noted	No known allergies per patient. Hypertension. No other conditions known.			1						1	Immunisation reaction; Injection site erythema; Injection site streaking; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2806AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U2017AB~UNK~IM~LA~TD ADSORBED (TENIVAC)~1	USA	Emergency room visit	Influenza
0335222	12/12/2008	CA	1.67	1	.7	F	12/12/2008	within 12 hours of preservative free influenza vaccine had fever 104 and had febrile seizure.  neg w/u.  had clear runny nose/viral illness at time of vaccine				Y					Y	12/01/2008	12/01/2008	0	nl cbc, ua, cxr	PVT	PVT		viral uri, clr runny nose without fever	stenosis nasolacrimal duct, ASD, VSD			1						1	Chest X-ray; Febrile convulsion; Full blood count normal; Pyrexia; Urine analysis	FLU3~SANOFI PASTEUR~UT2786FA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335224	12/12/2008	CA	1.25	1	.3	M	12/12/2008	right theigh cellulitis vs early abcess vs sterile abcess starting 9 days after immunization.  Treated with antibiotic Keflex									U	12/02/2008	12/11/2008	9		UNK	UNK						1						1	Abscess; Cellulitis	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B087AA~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2782CA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0265X~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1220X~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0335236	12/12/2008	AL	1.4	1	.4	M	12/12/2008	2nd Flu shot given. 8 days after shot a red pustule and abscess developed. Patient had sores in other spots before shot given.  Treated as MRSA boils.				Y					U	12/02/2008	12/10/2008	8	Incision and Drainage of Abscess - wound culture sent	PVT	UNK		None				1						1	Abscess; Culture wound; Erythema; Furuncle; Incisional drainage; Rash pustular; Staphylococcal infection	FLU3~SANOFI PASTEUR~UT27850A~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335239	12/12/2008	OR	87.0	87		F	12/14/2008	2 days after received flu shot, symptoms hit suddenly. Hard to breathe, choking, drainage in lungs, solid chunks of phlegm. Blocked passageway. Couldn't breathe. Did not go to Dr. Feverish-felt like she was on fire, Coughed so hard that her chest and ribs hurt. Symptoms lasted 3 weeks. She was drinking lots of water and lost weight.									Y	10/21/2008	10/23/2008	2		OTH	PVT		None				1						1	Choking; Cough; Dyspnoea; Feeling hot; Increased upper airway secretion; Pulmonary congestion; Pyrexia; Weight decreased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88805~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0335244	12/12/2008	MN	58.0	58		F	12/12/2008	Redness and swelling down left arm.									Y	12/09/2008	12/09/2008	0		PVT	PVT		No	Sarcoidosis			1						1	Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~UT2788GA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1407X~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0335245	12/12/2008	CA	23.0	23		F	12/12/2008	Pt. received flu shot 12/1/08, had soreness at site of injection. Still having pain @ injection site.									U	12/01/2008	12/04/2008	3		OTH	UNK		None				1						1	Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0335249	12/12/2008	MA	66.0	66		F	12/12/2008	Soreness; Bruising @ site  quarter- size per caretaker (pt not seen).									Y	11/14/2008	11/15/2008	1		PVT	PVT	ZYPREXA; COGENTIN; DEPAKOTE; vitamin C; SERAX/OXAZEPAM; MELATONIN; Multivitamin; SYNTHROID; POTASSIUM CHLORIDE K-DUR; ZOCOR (SIMVASTATIN); FOSOMAX; COLACE; LASIX; ATENOLOL; LANOXIN/DIGITEK; NYSTATIN POWDER; TIMOLOL MAL SOL; ALPHAGAN P; aspi	Left knee pain	APDM; MR; RAD; hypothyroid.			1						1	Injection site haematoma; Injection site pain	FLU3~SANOFI PASTEUR~U2948AC~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335250	12/12/2008	IN	54.0	54		F	12/11/2008	Significant swelling, redness from upper arm to elbow & rash appearance, painful for 4 days after administration.									Y	10/17/2008	10/18/2008	1		OTH	UNK		None	None			1						1	Erythema; Oedema peripheral; Pain; Rash	FLU3~SANOFI PASTEUR~SP2759AA~UNK~SC~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335251	12/12/2008	FL	76.0	76		F	12/12/2008	Swelling & pain Rt. arm.				Y					Y	10/28/2008	10/28/2008	0		PVT	PVT	LOZOL; ACTOS; propanolol; PRILOSEC; TRIOLIDE; ZOLOFT; COLAN SR; CELEBREX	None				1						1	Oedema peripheral; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLAA154AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0619X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0335252	12/12/2008	WI	6.0	6		M	12/12/2008	Day after flu vaccine had itchiness at injection site (12/11). On 12/12/08 am mom noticed upper arm to be swollen & hot to touch with c/o persistent itchiness as well.  Saw pediatrician & was directed to give oral antihistamines due to probable vaccine reaction.				Y					Y	12/10/2008	12/11/2008	1	None	PUB	PUB	KEPPRA	None	Seizures			1						1	Injection site pruritus; Oedema peripheral; Pruritus; Skin warm	FLU3~SANOFI PASTEUR~U2831AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335253	12/12/2008	OR	26.0	26		F	12/12/2008	PT. received Flu vaccine 12/11/08 @ approx 1:45 p.m.- No adverse events noted @ the time of injection.  PT. denied hx of allergies and signed appropriate consent forms.  @ 2037 pt had visit to ER (copies included)				Y					Y	12/11/2008	12/11/2008	0	See ER visit notes	PUB	UNK			Plantar fasciitis; migraine HA's			1						1	Hypersensitivity	FLU3~SANOFI PASTEUR~42809AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335254	12/12/2008	VA	49.0	49		F	12/12/2008	Pain began @ time of administration.  At day 3 client realized pain was not diminishing and due to this, client's ROM was and is limited.  Today is 9 wks post immunization, states pain is transient but when present is sharp upon movement and achy at night.  Pain is to high triceps brachii site, back of arm, described & points to site with fingers.									N	10/29/2008			None	PUB	PUB	FLOVENT/ALBUTEROL; SYNTHROID	L rotator cuff injury diagnosed (03/06)	Levaquin allergy/thyroid removed/asthma/mitral valve prolapse heart murmur			1						1	Joint range of motion decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLAA172AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0335228	12/14/2008	AL	62.0	62		F	12/14/2008	ON 11/11/08 AT 5 PM I RECEIVED THE FLU & PNEUMONIA VACCINE. BY 3 AM THE NEXT DAY THE ARM WITH THE FLU VACCINE WAS VERY SWOLLEN AND UNUSUALLY SORE.  LATER THAT DAY I STARTED RUNNING A FEVER,CHILLS AND RASH ON MOST OF THAT ARM.IT LATER SPREAD TO MOST OF MY TORSO. IT DIDN'T ITCH. THIS LASTED FOR MORE THAN 3 DAYS.  I TOOK IBUPROFEN & BENADRYL REGULARLY DURING THIS TIME. DIDN'T HELP MUCH.									Y	11/11/2008	11/12/2008	1	I HAD BEEN ON CEFTAN FOR A SINUS INFECTION FOR 1 MONTH PRIOR TO TAKING THE VACCINE.  I HAVE LUPUS, FIBROMYALGIA & SJOGREN'S, MY IMMUNE SYSTEM IS COMPROMISED, BUT THE RHEUMATOLOGIST DID NOT SEE A PROBLEM. I WAS IN CONTACT WITH HIM DURING THIS PERIOD OF TIME. I DO FEEL LIKE THIS WAS AN EXTREME REACTION TO THE VACCINE AND SHOULD BE CONSIDERED IN STATISTICS.	PVT	PVT	SYNTHROID-.100MCG,PLAQUENIL-400MG,QUINACRINE-200MG,WELBUTRIN-150MG, AMBIEN-10MG, TOPROL-	LUPUS, FIBROMYALGIA, SJOGREN'S SYNDROME,COMMON VARIABLE IMMUNODEFICIENCY, CHRONIC SINUSITIS	MOLD & DUST MITES			1						1	Chills; Injection site pain; Injection site swelling; Pyrexia; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~87949~7+~SC~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1384U~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0335240	12/14/2008	MA	4.0	4		M	12/14/2008	Confluent, itchy erythematous area around site of injection ((L) deltoid).									U	12/12/2008	12/14/2008	2		PVT	UNK	No	No	Atopic Dermatitis			1						1	Injection site erythema; Injection site pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~UT2783BB~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0332141	12/15/2008	CA	13.0	13		F	12/12/2008	Information has been received from a physician and office manager concerning a 13 year old female who was vaccinated with GARDISAL (lot#659657/14870) (date, dose not reported). Concomitant therapy included flu vaccine and PID The patient experienced fainting twice after receiving an injection with GARDASIL and required oxygen after the second time. The patient passed out and fell off the table onto her two teeth; on 28-Oct-2008 the patient was taken to a Medical Center. The patient was not admitted but received sutures for her mouth. The patient needed dental work as follow-up and planned to see a dentist. The office manager was unsure of the patient's current status. Additional information has been requested.									N	10/28/2008	10/28/2008	0	Unknown	OTH	OTH			Unknown		WAES0811USA01921	1						2	Fall; Immediate post-injection reaction; Mouth injury; Syncope; Tooth injury; X-ray; Fall; Loss of consciousness; Oxygen supplementation; Suture insertion; Syncope; Tooth injury	FLU3~SANOFI PASTEUR~U2757AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1487U~3~IM~RA~HPV (GARDASIL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~2|HPV4~MERCK & CO. INC.~1487U~UNK~UN~UN~HPV (GARDASIL)~2|UNK~UNKNOWN MANUFACTURER~~UNK~UN~UN~VACCINE NOT SPECIFIED (NO BRAND NAME)~2	USA		Influenza
0334287	12/15/2008	UT	45.0	45		F	12/11/2008	Initial report received from a patient who is a critical care nurse on 02 December 2008. A 45-year-old female patient received an intramuscular left deltoid injection of FLUZONE SV 2008-2009 (lot number U2804AA) on 16 October 2008 and seven days later, on 23 October 2008, she first noticed a stiff neck when doing pilates. She later noticed a tingling sensation on both trigeminal nerves, greater on the left than on the right. The patient also had a feeling of impending doom. The patient attributed the stiff neck to a previous muscle injury (not specified). It was also indicated that the patient had acupuncture on an unspecified date. Later in the evening of 23 October 2008, the patient experienced an electrical shooting sensation in all four extremities and went to the emergency room for evaluation. An MRI of the head and neck and a test on blood vessels (not specified) were normal. The patient was sent home with instructions to follow-up with a neurologist. By 27 October 2008, the symptoms had worsened. The patient complained of numbness and tingling in all extremities, which progressed to complete loss of sensation in both lower and upper extremities. Additionally, the patient had significant upper extremity weakness. The patient was admitted to the hospital and tests were completed to rule out GBS (Guillain-Barre Syndrome) and MS (Multiple Sclerosis). The final diagnosis was central demyelinization. The patient received treatment with SOLUMEDROL while in ICU (intensive care unit) with significant improvement. The patient was discharged from the hospital on 31 October 2008. At the time of the report, the patient had intermittent abnormal sensory feelings and intermittent upper extremity weakness. The patient continued to follow-up with her neurologist. Contact information for the neurologist was provided. Documents held by sender: None.  Follow-up: Intermittent dysesthesias of head/face, trunk/back, all 4 extremities. UE/shoulder girdle muscle weakness (initial strength good, endurance strong remains with affect). At 14 months post-event without complete resolution this degree of residual deficit may be permanent.					Y	4			N	10/16/2008	10/23/2008	7	MRI of the head and neck was normal. A test on blood vessels (not specified) was normal. Tests were completed to rule out GBS (Guillain-Barre Syndrome) and MS (Multiple Sclerosis).	PVT	UNK			The patient had no known allergies. The patient denied having a medical history; however it was also reported that the patient had a previous muscle injury (not specified). The patient also denied illnesses at the time of vaccination and use of concomitant medications. She denied receiving other vaccinations on 16 October 2008 and denied experiencing previous adverse events following prior vaccinations.		200803864	1						2	Anxiety; Blood test normal; CSF test normal; Dysaesthesia; Muscular weakness; Musculoskeletal stiffness; Nuclear magnetic resonance imaging normal; Paraesthesia; Sensory loss; Trigeminal nerve disorder; Demyelination; Hypoaesthesia; Intensive care; Laboratory test normal; Muscular weakness; Musculoskeletal stiffness; Nuclear magnetic resonance imaging normal; Paraesthesia; Sensory loss	FLU3~SANOFI PASTEUR~U2804AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2804A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0335262	12/15/2008	OH	32.0	32		F	12/11/2008	Initial information was received on 01 December 2008 from a health care professional. A 32 year old female patient with a possible sulfa allergy received an intramuscular right deltoid injection (lot number unknown) on 27 October 2008. 48 hours post vaccination, the patient developed a rash that began on her lower extremities and had spread everywhere except for her face. She was treated with ATARAX, MEDROL, and PREDNISONE. The rash persisted despite treatment. The rash was described as red, slightly raised with an abrasion type feeling. She also complained of itching and burning. The patient was not recovered at the time of the report. List of Documents held by Sender: None.				Y					N	10/27/2008	10/29/2008	2	None reported.	UNK	UNK			The patient had a possible sulfa allergy.		200803810	1						1	Burning sensation; Erythema; Pruritus; Rash generalised	FLU3~SANOFI PASTEUR~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335266	12/15/2008	NJ	1.9	1	.9	F	12/11/2008	Initial report was received 03 December 2008 from a health care professional. A 22-month old female patient with no past medical history, had received FLUZONE No Preservative 2008-2009 (route and site not reported), lot number UT2794GA on 02 December 2008 and 30 minutes later, she began vomiting which worsened to where the patient was vomiting bile and a coffee ground substance. The child was taken to the emergency room and admitted overnight. Laboratory test results included elevated WBC and BUN levels. The patient was discharged on 03 December 2008. The patient had no concurrent illness at the time of vaccination. The patient had not been taking any concomitant medications and had not received any other vaccines during the four weeks prior to receipt of FLUZONE. At the time of the report, the patient was not recovered from the event. This report was received as a cluster report. The reporter for this case is the same as in case 2008-03866 which involved the patient's twin sibling. Documents held by sender: None.				Y	Y	2			N	12/02/2008	12/02/2008	0	Elevated WBC and BUN	UNK	UNK			No known allergies. Denies any past medical history. The patient had not experienced any adverse event following prior vaccinations.		200803865	1						1	Blood urea increased; Haematemesis; Vomiting; White blood cell count increased	FLU3~SANOFI PASTEUR~UT2794GA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0335267	12/15/2008	NJ	1.9	1	.9	F	12/11/2008	Initial report was received 03 December 2008 from a health care professional. A 22-month-old female patient with no past medical history, has received FLUZONE no Preservative 2008-2009 (route and site not reported), lot number U12794GA on 02 December 2008 and 30 minutes later, she began vomiting which worsened to where the patient was vomiting bile and a thin coffee ground substance. The child was taken to the emergency room and admitted overnight. Laboratory test results included elevated WBC and BUN levels. The patient was discharged on 03 December 2008. The patient had no concurrent illness at the time of vaccination. The patient had not been taking any concomitant medications and had not received any other vaccines during the four weeks prior to receipt of FLUZONE. At the time of the report, the patient was not recovered from the event. This report was received as a cluster report. The reporter for this case is the same as in case 2008-03865 which involved the patient's twin sibling. Documents held by sender: None. Follow-up information received 19 January 2009 from a health care professional in the United States. The patient had no illness at the time of the vaccination and the reporter stated that both parents came down with a similar illness after they brought the patient home. According to the reporter, the patient recovered from the event. No additional information was provided. Follow up information received on 17 February 2009 from a health care professional in the United States. The patient received Fluzone at 4:30 pm on 02 December 2008. At 6pm the patient began vomiting. Initially the vomit was clear and later became blood tinged. The patient did not have diarrhea, rash, fever, decreased urine output, apparent abdominal pain or decreased alertness. However the patient did have decreased activity. The physical examination and review of system were unremarkable. Vital signs were pulse 161, respirations 32, temperature 37.1, and blood pressure 133/80. The patient was placed on physician's observation at 22:45 for vomiting and coffee ground emesis. The patient was treated with 20 cc/kg normal saline bolus. The patient was re-evaluated every 1-2 hours. During the first re-assessment, the patient received a second 20 cc/kg normal saline bolus and the patient improved. No further emesis was noted. During the second re-assessment the patient continued to improve. Laboratory data was reviewed at the time which included an elevated BUN 23, decreased creatinine 0.3, increased WBC 32.6. The patient was seen at 03:30 and had 2 episodes of emesis during that hour. The patient's abdomen remained soft and nontender. The patient was admitted to the pediatric unit. The patient did not have an egg allergy, gastrointestinal problems or any preceding illness. Mild pharyngeal erythema was noted upon assessment. The patient's diagnosis was Mallory Weiss tear, gastritis, and Digestion. No further information was provided. Follow-up information received 09 March 2009 from a health care professional in the United States who confirmed the patient had recovered from the event. The reporter had no additional information to provide at the time of the report. Follow-up information was received 12 June 2009 from a health care professional in the United States. FLUZONE No Preservative 2008-2009 had been administered as a subcutaneous left deltoid injection and the patient was reported to have been fully recovered on 07 December 2008. Both parents had recovered from their similar illnesses in two days and neither parent had received Fluzone. No further information was provided. This report was received as a cluster report. The reporter for this case is the same as in case 2008-03865 which involved the patient's twin sibling. Documents held by sender: medical records.				Y	Y	2			N	12/02/2008	12/02/2008	0	Elevated WBC and BUN levels. Laboratory data was reviewed at the time which included an elevated BUN 23, decreased creatinine 0.3, incrased WBC 32.6.	UNK	UNK			No known allergies. Denies any past medical history. The patient had not experienced any adverse event following prior vaccinations.		200803866	1						1	Activities of daily living impaired; Blood urea increased; Gastritis; Haematemesis; Mallory-Weiss syndrome; Pharyngeal erythema; Vomiting; White blood cell count increased	FLU3~SANOFI PASTEUR~UT2794G~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0335281	12/15/2008	AZ	53.0	53		F	11/19/2008	Vaccine given 10/6. Onset of progress neuologic sx starting 10/18. Initially sensory loss w/ T6 level progressed to motor loss LE w/loss of bladder control. Transferred to hosp. 11/15. Current working diagnosis is Neuromyelitis Optica. 12/29/08-records received for DOS 11/15/08-presented with C/O bilateral lower extremity weakness with T4 down decreased feeling and electric pins in her back when trying to move. Bladder incontinence and bowel constipation times 2 weeks. All symptoms began on 1025/08 with bilateral foot numbness slowly went up her legs and subsequent fall. Assessment: plantar neuropathy. Hyperglycemia steroid induced.  Gait disturbance. Deficits of activities of daily living.  Loss of vision in left eye. 4/8/09-DC Summary 11/26-12/17/08-DC DX:Transverse myelitis. Paraplegia. Neuropathic pain. Urinary tract infection with Klebsiella pneumoniae. Urinary rentention/neurogenic bladder. Neurogenic bowel. Spasticity. Treated with plasmapheresis.					Y	21	Y		U	10/06/2008	10/25/2008	19	MRI at hosp.  12/29/08-records received- CSF elevated RBC 59, polys 48, glucose 125 and protein 107, IGG CSF 16.9, albumin 68, synthesis RA 17.6. Inflammatory myelopathy with abnormal MRI of brain and cervical and thoracic spine and paraplegia. Visual evoked potentials abnormal. WBC 11.0 MRI of liver showing complex cyst.	PUB	PUB						1						1	Motor dysfunction; Neurological symptom; Neuromyelitis optica; Sensory loss; Urinary incontinence	FLU3~SANOFI PASTEUR~42764AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0335285	12/15/2008	GA	54.0	54		F	11/19/2008	Pt. reported development of redness and swelling below injection site; received injection at 11:57 AM, and symptoms developed that same evening on 11/12/08. Treated with Cephalexin 250 mg, one capsule four times a day for 10 days.									U	11/12/2008	11/12/2008	0	None	OTH	OTH	FOSAMAX Plus D; EFFEXOR XR	None	Osteoporosis; depression			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2771AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335286	12/15/2008	IL	2.0	2	.9	F	12/11/2008	Rec'd Fluzone 0.25 ml for firsts time. About 3 minutes after vaccination, client fainted - fell to floor- hit back of head. Had approximately 30 second seizure. Call to 911 - went to ER. Labs WNL - discharged to home. To follow up with MD today. MD doesn't feel vaccine was case of seizure. Is ordering sleep deprived brain wave test.				Y					Y	12/10/2008	12/10/2008	0	CBC - WNL	PUB	PUB	MIRALAX, 1/2 capsule	Cold - congested - no fever	None			1						1	Convulsion; Fall; Full blood count normal; Head injury; Syncope	FLU3~SANOFI PASTEUR~UT2788FA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335287	12/15/2008	LA	1.0	1	.0	F	12/05/2008	Shingles.									Y	11/10/2008	12/01/2008	21		PVT	PVT	None	None	None			1						1	Herpes zoster	FLU3~SANOFI PASTEUR~UT2783DA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB289CB~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1250X~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1216X~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0335288	12/15/2008	NJ	51.0	51		F	12/08/2008	First day of symptoms included severe muscular pain throughout my body, followed by strapping chest pains, which required hospital emergency visit. Weeks to follow included pains throughout chest, legs, arms, face, head, tingling in scalp and soreness. Extreme fatigue. Tightness in calves. Continual weak legs, head soreness and lightheadedness to date (5/6 weeks).				Y					U	10/29/2008	10/31/2008	2	Extensive blood work done; cardiology tests; thyroid tests; leg doppler tests/vein; neurology visit.	PUB	OTH		None	None			1						1	Blood test; Cardiac function test; Chest pain; Dizziness; Fatigue; Muscle tightness; Myalgia; Pain; Paraesthesia; Thyroid function test; Ultrasound Doppler	FLUX~UNKNOWN MANUFACTURER~ASLLA17SAA~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0335290	12/15/2008	IA	58.0	58		F	12/04/2008	Night of vaccination experienced chest and back aches. Following day was achy all over, temp of 100 degrees. Didn't work Friday 10/30, had no energy. Went back to work 11/3. Said has had several cold sores since. Also said knees ached.									Y	10/29/2008	10/29/2008	0		PUB	PVT	None	None	None			1						1	Arthralgia; Asthenia; Back pain; Body temperature increased; Chest pain; Oral herpes; Pain	FLU3~SANOFI PASTEUR~U2752AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335291	12/15/2008	NC	4.1	4		F	12/09/2008	5 1/2 cm across by 2 1/2 cm longitudinal, non-tender, non-indurated redness posterior aspect of mid-upper arm on left.				Y					Y	12/03/2008	12/04/2008	1		PVT	PUB	ZURTEC; Monetasone cream	Viral upper respiratory infection	Eczema; Hx of VSD, resolved.			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U2898EA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB257AA~2~UN~LA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1275X~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0335293	12/15/2008	CT	16.0	16		U		None										12/04/2008			None	PUB	PUB		None				1						1	Inappropriate schedule of drug administration; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500553P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB319AA~1~IM~LA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~0070X~4~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0335295	12/15/2008	NE	88.0	88		F	12/05/2008	C/O (R) arm, shoulder, neck pain since receiving flu shot on 10/10/08. Pt states reaction started aprx 1 month after recieving vaccine. No time given. 1-6-09 Pt states pain in sholder started within a few days of her flu shot but she cant remember exactly									Y	10/10/2008				PVT	PVT		F/U with Hypothyroidism	Polio, 36 years; HTN; CHF; DVT; Hypothyroid; COPD; Osteoporosis			1						1	Musculoskeletal pain; Neck pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2806AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335297	12/15/2008	CA	77.0	77		F	12/09/2008	Administered site for pneumococcal vaccine became swollen and painful. Had hard time raising the arm up. Symptoms lasted 4 days. Pt. had no reactions for the administered site of flu vaccine.									Y	11/17/2008	11/17/2008	0	None	OTH	PVT	None	None	None			1						1	Injected limb mobility decreased; Injection site pain; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~7+~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1382U~2~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0335299	12/15/2008	NY	15.0	15		F	11/06/2008	Knuckles painful and swollen couple of days after flu shot given.									N	10/27/2008	10/28/2008	1	See attached	OTH	OTH			Suprax	redness swellingdecrese ROM~Pneumo (Pneumovax)~2~6.00~In Patient		1						1	Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89982~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0335300	12/15/2008	CA				U		Large local reaction involving most of right upper arm.  24 hrs post administration of vaccine.									Y					PVT	PVT		0 X URI	Had large local reaction 2 yrs ago to FLUZONE.	lg loca vxnl~Influenza (Seasonal) (Fluzone)~1~5.00~In Patient		1						1	Local reaction	FLU3~SANOFI PASTEUR~U2800FA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335302	12/15/2008	VA	4.0	4		F	12/09/2008	Patient given FLUMIST, then DTap injection. Within 2-3 minutes began to complain of not being able to breath through nose, crying loudly, then nose/mouth hurt, then rash/redness was evident over face, becoming clearly hives within 5 more minutes. She was given EPI 1:1000 (0.25 cc) immediately(and BENADRYL 25 mg po(by mouth). Hives were never hypotensive. SQ/IM gone within 10 minutes and she felt well.				Y					Y	12/09/2008	12/09/2008	0	None	PVT	PVT	None		None			1						1	Crying; Dyspnoea; Erythema; Facial pain; Immediate post-injection reaction; Rash; Urticaria	DTAP~SANOFI PASTEUR~C3081AA~UNK~UN~UN~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500585P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0335304	12/15/2008	LA	27.0	27		F	11/25/2008	Pt. phoned health unit to report that feeling ill after receiving the flu vaccine. Pt. report that she was nauseated, diaphoretic, weak, and general body aches. Instructed to report to ER for evaluation.									Y	11/25/2008	11/25/2008	0	None	PUB	PUB	None	None	None		LA081203	1						1	Asthenia; Hyperhidrosis; Malaise; Nausea; Pain	FLU3~SANOFI PASTEUR~U2848AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335305	12/15/2008	LA	47.0	47		F	11/17/2008	States woke up morning after receiving flu shot with very stiff and painful back, feeling achy and stiff all over, but especially back and spinal cord area. Didn't take temp but feels feverish with sweating and chills. Took OTC fever/pain reducer. States felt achy for about 4 days in bed for most and of that period. Spoke to patient again on 11/17/08. States feels good now except same lower back stiffness and pain. occasionally.									Y	11/12/2008	11/13/2008	1		OTH	OTH	ZOLOFT; BP med; SIMUASTAFIN		Sulfa drugs allergy; Depression anxiety		CA081204	1						1	Back pain; Chills; Feeling hot; Hyperhidrosis; Musculoskeletal stiffness; Pain	FLU3~SANOFI PASTEUR~U2848AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335322	12/15/2008	IL	33.0	33		F	12/11/2008	Approx 5 days post had vaccine had change in pain of Lt arm @ injection area; that same pain persists; using Ibuprotin, at hapizal KETAPROTN given.										11/19/2008	11/24/2008	5		PVT	PVT						1						1	Injection site pain	FLU3~SANOFI PASTEUR~U2789DA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335323	12/15/2008	IL	15.0	15		M	12/11/2008	12-9-08 Pa from pt father; c/o soreness of Rt arm since flu vaccine of 11-4-08; initially had some redness which resolved; pain began approx 7 wk later; pt c/o difficulty lifting arm due to pain.										11/04/2008				PVT	PVT	None		Allergy to PCN, Sulfa			1						1	Erythema; Injected limb mobility decreased; Pain in extremity; Tenderness	FLU3~SANOFI PASTEUR~U27890A~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2618AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0335328	12/15/2008	AZ	51.0	51		F	12/09/2008	Site of injection left deltoid with pain, burning up to 4d after vaccine.				Y					U	12/05/2008	12/05/2008	0	None	PVT	PVT	LEVOTHYIOXINE	None	Hypothyroid; Hyperlipidemia			1						1	Injection site irritation; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89980~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0335330	12/15/2008	FL	46.0	46		F	12/15/2008	red itchy hot rash appeared within 30 mins of shot, face brought out in bright red rash. I have actually broken out since this shot 5 more times the same way. I start getting warm and feel it coming on and within 10 mins of that feeling I am completely broken out and it lasts over 1 hour with taking benedryl. The rash comes and goes now and I had Epsten Barr Virus exposure in the military, so not sure but it feels like it trigger something in my body now.									Y	10/24/2008	10/24/2008	0		PUB	PUB		none	had epstein barr, chronic fatique 1996-97	NONE~ ()~NULL~~In Patient		1						1	Feeling hot; Rash erythematous; Rash generalised; Rash pruritic	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0335331	12/15/2008	MI	14.0	14		M	12/15/2008	Patient received TIV (0.5mL, Sanofi Pasteur) into the right deltoid on 12-12-2008 in the afternoon.  Mom called 12-12-2008 at 4:21 to report that patient had a bright red, pruritic rash, from head to toe within 1 hour following the Influenza vaccine.  Mom reports  that he has a history of allergy to tomato skin, but to nothing else.  Mom took patient to a prompt care and was given a prescription for Benadryl. The rash was completely gone by Sunday afternoon.				Y					Y	12/12/2008	12/12/2008	0	none	UNK	UNK	Adderall	Healthy	Tomato allergy			1						1	Rash erythematous; Rash generalised; Rash pruritic	FLU3~SANOFI PASTEUR~U2839AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335337	12/15/2008	CA	13.0	14		F	12/15/2008	fever, weakness, joint pain, chest and stomach pain, loss of appetite									Y	11/26/2008	11/27/2008	1		PVT	PVT						1						1	Abdominal pain upper; Anorexia; Arthralgia; Asthenia; Chest pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~2~UN~LA~HPV (GARDASIL)~1	USA		Influenza
0335345	12/15/2008	WI	3.0	3		F	12/15/2008	DATE: 10/18/08. CHIEF COMPLAINT: Unable to close left eye, unable to smile with left mouth. HISTORY OF PRESENT ILLNESS: This is a 3-year-old female who has been healthy until 2 weeks ago. She had an upper respiratory viral illness, namely coughing, sneezing, runny nose and has been rubbing her eyes, which resolved by last week. She was seen by her primary care provider 10/15/08 and received an influenza vaccination. Last night, Mom noticed that she was blinking only with her right eye. When mother asked patient to squeeze her eyes tightly, she was not able to close her left eye tightly and her left mouth did not move when she was smiling. The angle of her left mouth was dropping. Eating and drinking were as usual. Her urination and bowel movements were also as usual. She did not complain of headache, fever, nausea, or vomiting. Mom denied constipation or diarrhea. Mom also denied dribbling of fluid or liquid when she was eating or drinking. There was no history of exposure to tick bites. Of note, all the family members went out for corn picking last Sunday. They played with donkeys in the barn but Mom did not notice any tick bites or or any skin lesions. There is a family history of seizure. Patient's 11-year-old sister had a one time, generalized, tonic/clonic seizure when she was in kindergarten. It was a one-time event. She has been on seizure medication so far is being followed. The patient herself does not have any history of seizure or cardiac disease. PHYSICAL EXAMINATION:  VITAL SIGNS: Temperature 97.7, pulse rate 120, respiratory rate 32, O2 saturation 100% on room air. HEAD: Atraumatic without bruising, ecchymosis or soft tissue swelling. EYES: Slight conjunctival injection, but I did not see clear eye discharge or red eyes. The patient cannot close her left eye tightly. The left angle of the mouth is dropping. She cannot smile with the left mouth and cannot frown, no wrinkles on forehead. EARS: Clear without hemotympanum. NECK: No pain. No tenderness. No bogginess. No lymphadenopathy. CARDIOVASCULAR: No murmur. S1 and S2 are present. Rate and rhythm are regular. LUNGS: Lung sounds are clear bilaterally on auscultation. I did not hear any wheezing or crackles. SKIN: Shows no eruptions. No lesions. No erythematous changes.  NEUROLOGIC: Patient is playful, pleasant, smiling and giggling playing with her daddy. She is neurologically intact, except for the findings as described above in the history of present illness. EMERGENCY ROOM COURSE: The patient was seen, examined and discussed with senior resident and the pediatric neurologist. I explained the differential diagnosis for Bell's palsy, explained that 85% are idiopathic. Also explained that living in the tick endemic area, we need to rule out the possibility of Lyme disease. Also explained that viral illness like herpes simplex virus or Ramsay-Hunt syndrome by reactivation of a varicella due to virus can cause bell's palsy and chances for these are low. I also explained the possibility of otitis media as the probable cause, but which is unlikely as her tympanic membranes are clear. We explained the nature and course of the Bell's palsy and decided to test for Lyme disease, herpes simplex I and II and mycoplasma enzyme immunoassay. We provided a prescription for prednisone by mouth 15 mg once daily for 7-day course followed by another 2 days of tapering. We also provided information about eye care using the eye drops and eye patch during nighttime to prevent corneal abrasions. The patient was discharged from the emergency room. IMPRESSION: Left Bell's palsy, etiology unclear.				Y					U	10/15/2008	10/16/2008	1	1. Negative IgG and IgM Mycoplasma pneumoniae and nonreactive LYME EIA. 2. HSV, IgG antibody was positive for HSV-I.	UNK	UNK	Tylenol prn; Motrin prn	Viral Upper Respiratory Infection -  2 weeks prior to the immunization	History of Herpangina			1						1	Blood immunoglobulin G; Blood immunoglobulin M; Borrelia burgdorferi serology negative; Conjunctival hyperaemia; Facial palsy; Herpes simplex; Herpes simplex serology positive; Pneumonia mycoplasmal	FLU3~SANOFI PASTEUR~U2809AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335347	12/15/2008	MO	55.0	55		F	12/15/2008	It is unlikely that the adverse effect is from the vaccine but from damage to the tendon from the placement of the shot in the tendon. Have experienced pain for getting close to two months. Pain in right arm especially in shoulder but also elbow lower arm and some in hand and fingers.  Pain has continued since the shot was administered.  Started physical therapy December 8.  Would have started sooner but was out of the country.									N	10/25/2008	10/25/2008	0	tendonitis	PVT	UNK		none	Non-Hodgkins Lymphoma			1						1	Drug administered at inappropriate site; Musculoskeletal pain; Pain in extremity; Tendonitis	FLU3~CSL LIMITED~01949111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0335348	12/15/2008	CA	33.0	33		F	12/15/2008	Left shoulder/arm pain started after flu shot 2 weeks ago.  I have been icing it and taking ibuprofen.  C/O weakness in left arm.  Then, as of 11/19/08, 14 days after vaccination, her pain had continued.  She then disclosed that she had left shoulder pain 2-3 days prior to the vaccine.  She was referred to her PCP for f/u evaluation and treatment									U	11/05/2008	11/05/2008	0	None	PVT	PUB	acetaminophen, ibuprofen	Left shoulder pain before injection, not made known to administrating nurse.	Recurrent tendonitis of right wrist, uterine prolapse, s/p vaginal hysterectomy			1						1	Muscular weakness; Musculoskeletal pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2757AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335349	12/15/2008	SD	45.0	45		M	12/15/2008	Client called my home phone four days after receiving his flu vaccination. Client stated that when he got to thinking about it, he decided he better report the reaction he had. Client stated that after receiving vaccine he went home and was feeling tired. He had been dealing with some type of cold so he took a nap around noon. When he woke up his eyes were burning, watering and swollen, his throat was sore and it hurt to swallow. Client states he took some Benadryl and lay back down and when he soke a couple of hours later he felt fine.									Y	11/04/2008	11/04/2008	0		UNK	UNK		Client did fill out form and checked that no the client was not sick today. Client did state on phone that he had been having a little cold.	Seasonal allergies			1						1	Eye irritation; Eye swelling; Fatigue; Lacrimation increased; Odynophagia; Oropharyngeal pain	FLU3~SANOFI PASTEUR~U2760AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335351	12/15/2008	WI	46.0	46		F	12/15/2008	began coughing, noticed throat felt tight, increased thick saliva, chills, pulse rapid at 100 bpm.  Used 4 puffs of albuterol inhaler before feeling relief									Y	12/11/2008	12/11/2008	0	no	MIL	UNK	Albuterol, occasional use, Synthroid	none	hypothyroid			1						1	Chills; Cough; Heart rate increased; Salivary hypersecretion; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA350BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0335356	12/15/2008	AK	1.33	1	.3	F	12/15/2008	7:pm on day of vaccination parents noticed child having a high heart rate. Around midnight child's arms/legs were twitching and jerking, fussy, temp 101.7. Tylenol given at home. At 4:00 am child was taken to the emergency room, heart rate 220, tx: an EKG was attempted but it was not completed, Motrin administered, heart rate decreased to wnl, temp 99.7, twitching was noted at ER; parents were told child was not having seizures. child was discharged at 8:00 am. Mother stated child's twitching gradually fully resolved after about 36 hours from onset. Low grade temp <100 degrees on 12/15/08.				Y					Y	12/12/2008	12/12/2008	0		PUB	PUB		no	none	none~ ()~NULL~~In Patient|none~ ()~NULL~~In Sibling1|none~ ()~NULL~~In Sibling2		1						1	Body temperature increased; Dyskinesia; Heart rate increased; Irritability; Muscle twitching	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B167AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2786GA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0841X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1188X~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0335365	12/15/2008	NC	56.0	56		F	12/03/2008	After flu shot - pain down to fingertips for 2 days after injection.  Noticed difficulty lifting arm higher than shoulder.  Per MD - tendonitis - 6 days Methyl prednisone per patient.									U	11/17/2008	11/17/2008	0	None - 12-12-08 - back to MD - on Flexoril and pain (Ibuprofen).	PUB	UNK	None					1						1	Injected limb mobility decreased; Pain in extremity; Tendonitis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA185AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0336531	12/15/2008	AZ	10.0	10		F	12/12/2008	Information has been received from a nurse concerning a 10 year old female who on 25-NOV-2008 was vaccinated with GARDASIL (lot # not provided) for her first dose.  ON 25-NOV-2008, after receiving GARDASIL, the patient fainted.  The patient sought medical attention and recovered on 25-NOV-2008.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/12/2008.  Follow up information was received from the nurse practitioner.  It was reported the patient was vaccinated with GARDASIL intramuscularly in the left deltoid.  Concomitant therapy also given on 25-NOV-2008 included FLUZONE (lot # U2772AA) which was was vaccinated with intramuscularly in the right deltoid on the same day.  Right after GARDASIL was given the patient fainted.  Her eyes rolled back and had some shakiness.  No further information was available.				Y					Y	11/25/2008	11/25/2008	0	Unknown	PVT	PVT	Unknown		Unknown		WAES0811USA04129	1						1	Eye rolling; Immediate post-injection reaction; Syncope	FLU3~AVENTIS PASTEUR~U2772AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~~1~IM~LA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0336548	12/15/2008	IN	11.0	11		F	12/12/2008	Information has been received from a consumer concerning her 11 year old daughter who on 16-OCT-2008 was vaccinated with her first dose of GARDASIL (route and site not reported). Concomitant therapy included flu vaccine in the same day. On 16-OCT-2008, later that evening the patient experienced vomiting and nausea and was hospitalized for at least 4 days. Patient was vomiting almost every half an hour for those days. When the patient was brought home, she started vomiting again and was hospitalized the second time for 2 days. The patient was recovering. The patient was tested for computed axial tomography (cat scan), magnetic resonance imaging (MRI) and blood test with no result. Follow-up information was received from a registered nurse. The nurse stated that the patient received dose 1 of GARDASIL 0.5 ml IM on 16-OCT-2008. The patient was treated with Phenergan and her symptoms were almost completely resolved. Additional information has been requested. Follow up information was received from the patient's mother concerning her 11 year old daughter. The patient had symptoms of respiratory abnormality at the time of vaccination. On 16-OCT-2008 the patient was vaccinated with GARDASIL (lot number 659657/1487U) IM into her left arm. Concomitant therapy included FLUZONE (lot number U2761AA) IM into her left arm. On 17-OCT-2008 the patient experienced vomiting and was hospitalized. The patient had stayed in the hospital for 4 days. Complete blood count. Streptococcus. basic metabolic panel, urinalysis, chest poster-anterior/laterial and gastric occult blood were performed with no result reported. The patient recovered at the time of reporting. Additional information is not expected.   1/22/09 Received PCP medical records of 10/16-10/25/2008.  Records reveal pt in state of usual health on day of vaccination.  Later same day, parent had to pick up from school due to SOB, weakness & dizziness.  Seen same day by PCP & dx w/allergic rhinitis.  Tx w/antihistamines.  Developed vomiting.  RTC 10/20 for same & sent to hospital.  RTC 10/24 s/p hospitalzation.  Concerns for PVCs noted in hospital & continued lightheadedness, otherwise feels well.  Referred for Holter monitor.  Recurrent vomiting 10/25 & was readmitted to hospital.  1/22/09 PCP records included hospital medical records of 10/20-10/23/2008. FINAL DX: vomiting w/dehydration & viral exanthem Records reveal patient experienced bilious vomiting x 5 days, poor appetite, lack of sleep, fatigue.  Had been seen in PCP office previous week for viral infection w/SOB & dizziness. In hospital had nausea & diarrhea.  On 3rd day in hospital developed facial flushing & rash.  1/30/09 Received additional hospital medical records of 10/25-10/26/2008. FINAL DX: dehydration, bilious vomiting & sinusitis Tx w/IVF & oral antibiotics.  Improved overnight & d/c to home on continued oral antibiotics w/PCP f/u.				Y	Y	6			Y	10/16/2008	10/16/2008	0	Unknown LABS: rapid strep neg. CXR neg.  Segs 82.1%(H), monos 3.3(L).  CO2 21(L), creatinine 0.6(L). Calcium 10.7(H).   Gastric occult blood neg.  UA abnormal w/protein & ketones; c/s neg.  Abdominal/KUB x-ray neg.  Sinus x-ray WNL.  Abdominal CT scan WNL except for right renal lesion, likely cyst. EKG showed sinus arrhythmias.    10/25/08 labs: segs 85%(H), lymphs 11.1%(L), monos 3.6%(L).  ALP 373(H), CO2 19(L). Calcium 10.3(H).  UA WNL.  Abdominal CT scan WNL.	PVT	PVT	Influenza virus vaccine		None   Respiratory abnormality, unspecified.  PMH: feeding issues in infancy.  behavior problems.  Cardiac arrhythmia.  Allergies & asthma.  Family hx: thyroid disorders.		WAES0811USA03689	1						1	Dizziness; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U2761AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1487U~1~IM~LA~HPV (GARDASIL)~1	USA	Hospitalisation	Influenza
0336678	12/15/2008	CA	17.0	17		F	12/12/2008	Information has been received from a physician concerning a 17 year old female patient with penicillin allergy and without illness at time of vaccination, who on 12-NOV-2008 at 11:30 was vaccinated with the third dose of 0.5ml GARDASIL (lot # 661766/0652X)  IM in the right arm and concomitantly at the same time with FLUVIRIN (lot # 89981) IM in the right arm.  On 12-NOV-2008 at 11:55, the patient experienced syncope.  The patient was sitting in exam room after injection for 15 minutes, with no problems, after getting up and walked in the hallway, she fell to the ground.  Right after hitting the ground she opened her eyes.  On the same date, the patient recovered.  The patient sought unspecified medical attention.  Additional information has been requested.									Y	11/12/2008	11/12/2008	0	Unknown	PVT	OTH		Penicillin allergy			WAES0811USA01860	1						1	Fall; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89981~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HPV4~MERCK & CO. INC.~0652X~3~IM~RA~HPV (GARDASIL)~1	USA		Influenza
0336759	12/15/2008	CA	15.0	15		F	12/12/2008	Information has been received from a physician. The physician who reported this did not administer the dose of GARDASIL vaccine to this patient and therefore does not know if this was reported already by the physician who did administer it.  It was reported that a female patient was very nervous about receiving their second dose of GARDASIL and told the physician several times that she was going to faint.  After receiving the vaccine she became very pale, fainted and became very rigid.  The physician noted that it was not a seizure.  The patient was sent to the emergency room but it is not known if she was admitted to the hospital.  Subsequently, the patient recovered.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/12/2008. Follow up information has been received from a Nurse Practitioner and medical records reporting that the patient, a 15 year old non-smoker with no known allergies, was vaccinated with the first dose of GARDASIL at 11:35 on 12-AUG-2008. The patient was vaccinated with the second dose of GARDASIL at 18:10 on 20-OCT-2008 (lot no. 661530/0575X). Concomitant therapy included the flu vaccine (lot no. u2804AA) on 20-OCT-2008. Concomitant medication included an unspecified acne medication. Just after receiving vaccination for GARDASIL and flu shot, the patient suffered a syncopal episode in the doctor's office. The patient fainted. She suffered no trauma with this episode. When recovered she became nauseated and dizzy. Just after the episode nurses took her vital signs and found her with a blood pressure 116/70, pulse rate 70 and oxygen saturation 100%. The patient was feeling a little queasy and now she felt better. The patient had no headache or chest pain or abdominal pain. She was currently menstruating. There had been no history of heavy bleeding or anemia, the patient has had no history of hypoglycemia or metabolic disturbance. There had been no recent history of vomiting or diarrhea. The patient was otherwise healthy. The patient was sent to the emergency room for further evaluation. It was reported on the medical records that Constitutional symptoms: no fever, no chills. Past medical history: Unremarkable. Medications: Medication for acne. Allergies: No Known drug allergies. FH: Noncontributory. Social history: No smoking, no drinking, no illicit drug use. Physical exam: Thin female teenager in no acute distress. Vital Signal: temperature 98.7, pulse rate 60, respirations 19, blood pressure 118/67, oxygen saturation 97% on room air. Neuro: intact and non-focal motor, DTR and cranial nerve examination. Light touch sensation intact throughout. Normal gait. Accu-Chek reveals a serum glucose of 98. Intervention: The patient was placed on cardiac monitor. No ectopy or arrhythmia were seen. Vital signs at 2005 revealed blood pressure 111/61, pulse rate 70, oxygen saturation 100%. Discussion: Risk of complications and morbidity if untreated are potentially moderate. Differential diagnosis was considered for syncope from noxious stimuli i.e, vaccination injection. Diagnosis: Syncopal episode. Disposition: The patient is discharged in stable condition. Parents were given printed ACI. She should follow up within 1 to 2 days if symptoms recur. No further information is available.				Y					Y	10/20/2008	10/20/2008	0	Unknown; blood pressure, 10/20/08, 116/7; blood pressure, 118/6; blood pressure, 10/20/08, 116/7; total heartbeat count, 10/20/2008, 70; pulse oximetry, 97%; pulse oximetry, 10/20/08, 100%; serum glucose, 10/20/08, 99;  total heartbeat count, 60	PVT	PVT	Unknown	Non-smoker	Unknown		WAES0811USA00758	1						1	Blood glucose normal; Blood pressure increased; Dizziness; Heart rate normal; Muscle rigidity; Nausea; Nervousness; Oxygen saturation; Pallor; Syncope; Syncope	FLU3~SANOFI PASTEUR~U2804AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0575X~2~UN~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0336760	12/15/2008	NH	14.0	14		F	12/12/2008	Information has been received from a registered nurse concerning a 14 year old female with sulfonamide allergy, Penicillin allergy, and asthma who on 29-Oct-2008 was vaccinated at another office with GARDASIL (661766/0652X) intramuscularly in her left arm. Secondary suspected therapy included MENACTRA in her left arm and an unspecified influenza virus in her right arm. All 3 vaccines were received on the same day. The nurse stated that the patient developed a reaction after receiving the 3 vaccines. On 29-Oct-2008 the patient experienced pain bilaterally in her upper and lower back. The patient said her mouth felt funny but had no problem swallowing. The patient had ear pain on her right side and ear turned red. The patient also reported mild aches in thighs and knees and a fever of 101f with generalized body aches and fatigue. The patient was seen in the office of the reporter for these symptoms on 30-Oct-2008 and had a transient hive like rash on the underside of her left upper arm. The patient also had mild difficulty breathing (her peak flow rate was usually 500 and it dropped to 350). Subsequently, the patient recovered. Additional information has been requested.									Y	10/29/2008	10/29/2008	0	Peak expiratory flow 10/30/08 350 usual, body temp 10/29/2008 101 degr - fever,	OTH	OTH	Unknown		Sulfonamide Allergy, Penicillin Allergy; Asthma		WAES0811USA00742	1						1	Back pain; Body temperature increased; Dyspnoea; Ear pain; Erythema; Fatigue; Injection site reaction; Oral dysaesthesia; Pain; Peak expiratory flow rate decreased; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~0652X~UNK~IM~UN~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~~UNK~IM~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0336906	12/15/2008	IA	0.6	0	.6	F	12/12/2008	Information has been received from a health professional and from a medical record which was reviewed concerning a four month old female infant who on 02-JUN-2008 was vaccinated with a first dose of ROTATEQ.  On 02-OCT-2008 the infant was vaccinated with a second dose of ROTATEQ.  Concomitant therapy included Hib conj vaccine (OMPC) (manufacturer unknown), PEDIATRIX, PREVNAR and FLUZONE.  It was reported in the medical report that the infant visited the doctor's office on 18-JUL-2008.  The mother reported that her baby experienced mattering of left eye with redness for the last two days.  The infant also had runny nose.  She was treated with VIGAMOX one drop twice daily for five days and treated both eyes.  The infant had a very small bony prominence redness or pain noted.  The healthcare professional would continue to monitor the event.  No treatment was ordered.  The mom was instructed to call the office if symptoms worsen or had any new concerns.  On 06-AUG-2008 the patient  was seen in the doctor's office.  It was reported that the baby experienced fussiness, irritability.  Her nose was mildly congested and her throat was red.  The infant had a positive strep test.  Laboratory test result showed the infant's white count was elevated (14.4 10^3/uL).  She was treated with OMNICEF 125 mg per 5cc, 3cc a day for ten days.  On 10-SEP-2008 the infant came to the doctor's office and noted to have nasal drainage and fussiness.  It was reported that she had nasal drainage and fussiness for the last two days and had cough.  It was reported that the infant had mild right  ear effusion, sinusitis and mild external swelling of the ear canal.  She was treated with AMOXICILLIN 125 mg, 5cc three times a day for ten days.  The mother reported that on 10-OCT-2008 the infant was vaccinated with FLUZONE in the office in her thigh.  The infant came to the doctor's office on 22-OCT-2008 and it was reported that she experienced non productive cough, rhinorrhea.  There was no sign of infection.  At the time of this report the outcome of the events were unknown.  Additional information is not available.									U	10/02/2008			Diagnostic laboratory, 08/06/08, strep screen was positive;  NBC count, 08/06/08, 14.4 10^3	OTH	OTH			Unknown		WAES0811USA02266	1						1	Auricular swelling; Cough; Erythema; Eye discharge; Irritability; Laboratory test abnormal; Middle ear effusion; Nasal congestion; Ocular hyperaemia; Pharyngeal erythema; Rhinorrhoea; Sinusitis; Streptococcal identification test positive; White blood cell count increased	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~~2~UN~UN~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~~2~UN~UN~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~~2~UN~UN~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0300326	12/16/2008	TX	1.3	1	.3	M	12/01/2008	Initial and follow-up information has been received from a physician and a licensed vocational nurse concerning a 15 month old male with small muscular ventricular septal defect who on 27-NOV-2007 was vaccinated IM, into the right leg, with a third dose of COMVAX (lot # 657380/0377U).  Concomitant suspect vaccination given on the same day included a first dose of VAQTA (lot # 659187/1259U) administered IM into the left thigh, a fourth dose of PREVNAR (lot # B0802D), administered IM into the right thigh and first dose of FLUZONE (lot U2461AA) administered IM into the right thigh.  Other concomitant vaccination on the same day, included a fourth dose of DIPTHERIA TOXOID (+) PERTUSSIS ACELLULAR vaccine (unspecified) (+) TETANUS TOXOID (Lot # C2760AA) administered IM into the left thigh.  On 27-NOV-2007, later the same day, the patient developed a fever which went up to 102 degrees.  Also, the patient's developed erythema and tenderness of the right thigh and right leg was swollen and she was fussy and lethargic.  On 29-NOV-2007, the child came in to the physician's office and the physician recommended warm compresses and BENADRYL.  On 29-NOV-2007, the patient recovered from fever.  On an unspecified date, the patient recovered from erythema and tenderness of the right thigh.  Additional information is not expected.				Y					Y	11/27/2007	11/27/2007	0	temperature measurement 11/27/07 -  up to 102 degrees	UNK	UNK		Ventricular septal defect			WAES0712USA06692	1						2	Body temperature increased; Injection site erythema; Injection site pain; Injection site swelling; Irritability; Lethargy; Oedema peripheral; Pyrexia	DTAP~SANOFI PASTEUR~C2760AA~4~IM~UN~DTAP (DAPTACEL)~2|FLU3~SANOFI PASTEUR~U2461AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|HBHEPB~MERCK & CO. INC.~0377U~3~IM~UN~HIB + HEP B (COMVAX)~2|HEPA~MERCK & CO. INC.~1259U~1~IM~UN~HEP A (VAQTA)~2|PNC~PFIZER\WYETH~B08702D~4~IM~UN~PNEUMO (PREVNAR)~2	USA	Emergency room visit	Influenza
0310016	12/16/2008	MD	79.0	79		M	11/19/2008	November 2007: Patient continued with weakness in legs, weakness in arms, unable to swallow. Needed complete assistance with stairs. 12/8/07: Admitted to hospital. Aspiration pneumonia, dehydration, malnourished, failed Modified Barium Swallow, Cardiac Output=10%, Diagnosis-Neuropathy. 12/11/07: Patient transferred to ICU due to respiratory and cardiac problems. 12/12/07: G-tube inserted due to failed Modified Barium Swallow. 2/4/08: Patient discharged from hospital to rehab. 2/17/08: 911 was called, due to decrease in oxygen saturation. 2/21/08: 3:00pm - Discharged from hospital and returned to rehab. 7:00pm - Called 911 - Respiratory distress-intubated. Admitted to hospital. 2/27/08: Patient was transferred. Lumbar puncture-inconclusive. 3/1/08: Ex-tubated. 3/2/08: Re-intubated. 3/7/08: Tracheotomy performed. 3/22/08: Patient was transferred to another hospital. 4/2/08: Patient was discharged from hospital on home hospice to daughter's home. Patient required 8-10 hours of daily private-pay nursing. Remainder of care provided by son and daughter. 4/10/08: 911 was called. Patient had distended abdomen, vomiting. Patient admitted to hospital. 4/16/08: Discharged from hospital on Home Health to daughter's home. Patient still required 8-10 hours private-pay nursing. The remainder of care was provided by son and daughter. 6/21/08: Admitted to hospital. Patient had urinary tract infection, diarrhea, thick yellow discharge from tracheotomy. 6/30/08: Patient admitted to nursing home. Facility had an unsuccessful attempt to wean off tracheotomy. 8/8/08: Follow-up visit at outpatient center with Dr. Diagnosis: MADSAM-a variant of Guillain-Barre Syndrome causally related to the flu shot. 8/20/08: discharged from nursing home to his house on Home Health Care. He requires 8-10 hours of daily private-pay nursing. The remainder of care provided by son and daughter. 10/29/08: Admitted to facility for 30 days of respite care.			Y	Y	Y	0	Y	Y	N	10/29/2007	11/01/2007	3	12/18/07 - Failed modified barium swallow; 12/7/07 Cardiac output test 10%; Lumbar puncture - inconclusive Feb08	OTH	PVT	Multivitamin; fish oil cap; aspirin; atenolol; lisinopril; etodolac; METROGEL	None	Herniated disk; High blood pressure	~Influenza (Seasonal) (no brand name)~1~79.00~In Patient		1						2	Dysphagia; Gait disturbance; Guillain-Barre syndrome; Movement disorder; No reaction on previous exposure to drug; Surgery; Tracheostomy; Abdominal distension; Asthenia; Barium swallow abnormal; Cardiac disorder; Dehydration; Diarrhoea; Dysphagia; Endotracheal intubation; Guillain-Barre syndrome; Lumbar puncture; Malnutrition; Neuropathy peripheral; Pneumonia aspiration; Respiratory distress; Tracheostomy; Urinary tract infection; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80684~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80684~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0313723	12/16/2008		44.0	44		F	09/25/2008	A 44-year-old female patient had received an intramuscular left deltoid injection of FLUZONE No-Preservatives 2007-2008, lot number U2475KA, and on the day of vaccination, she complained of pain at the injection site. Two days later, the pain became severe. Corrective treatments consisted of MOTRIN. On 20 December 2007, the patient received a physician's evaluation and subsequent x-ray with negative results. According to the reporter, it was possible that the vaccine may have been administered too high in the shoulder area, possibly into the bursa. At the time of the report, the pain intensity was mild and the patient reported a shooting pain through the arm when the shoulder was adducted. The patient had a pre-existing allergies to penicillin, amoxicillin and CECLOR and had not been ill at the time of vaccination. Concurrent medications included VITORIN. At the time of the report, the patient had not recovered from the event. Follow-up information was received 14 May 2008 from a health care professional. According to the reporter, the patient had no history of arm pain. The pain at the injection site began immediately after vaccination and was severe for two days (previously reported as two days later, pain became severe). The pain was located high on the patient's left arm just below the joint. An X-ray of the patient's left shoulder was performed with negative results; no bone or joint abnormalities and no soft tissue calcification were seen. The patient was evaluated by a specialist and diagnosed with Subacromial Bursitis and soft tissue inflammation secondary to FLUZONE. She had been evaluated by the specialist on 04 January 2008, 21 January 2008 and 18 February 2008 (evaluation results not reported). On 05 May 2008, the patient reported to their health care provider that their arm is good now, sometimes hurts to life, still tender to touch. No further information was provided at the time of the report. Follow-up information received on 13 June 2008 from a physician. This reporter had no additional information to add to the case. No other relevant medical information was added to the case. Follow-up information was received from the original physician on 03 July 2008. The physician had only seen the patient once, and was not aware of her recovery status. Per the physician, I believe vaccine was injected into subacromial area accidentally by student nurse. Not problem with vaccine- bad placement- too high on arm.									U	11/15/2007	11/15/2007	0	X-ray of left shoulder (negative) - no bone or joint abnormally and no soft tissue calcification.	UNK	UNK	VYTORIN		The patient had a history of allergies to Penicillin, Amoxicillin and Ceclor and had not been ill at the time of vaccination. Concomitant medications included Vitorin. The patient had no history of arm pain.		200800024	1						2	Bursitis; Drug administered at inappropriate site; Immediate post-injection reaction; Injected limb mobility decreased; Injection site pain; Pain; Soft tissue inflammation; Tenderness; Vaccination complication; X-ray limb normal; Bursitis; Drug administered at inappropriate site; Immediate post-injection reaction; Injection site pain; Pain; Pain in extremity; Soft tissue inflammation; Tenderness; X-ray normal	FLU3~SANOFI PASTEUR~U2475KA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2475K~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0333292	12/16/2008	FL	66.0	66		F	12/07/2008	At sight of injection very swollen (app. 4), very red, and painfull.  Lasted about 3 to 4 days.  No treatment except cold compresses for 10 minutes at least 4 times a day.									Y	11/25/2008	11/26/2008	1	None	PUB	PUB	PROTONICS	No	Allergy to sulfa			1						2	Injection site erythema; Injection site pain; Injection site warmth; Injection site erythema; Injection site pain; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA166AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA		Influenza
0335360	12/16/2008	KS	21.0	21		M	12/16/2008	Mid Sept 2008 rec'd smallpox vaccine, never scabbed but healed with large 2-in diam scar over the month and a half.  Early Dec with papular rash on arms, intense itchiness for 2 weeks.  Has had some soap changes and may be unrelated to vaccine.  Given antihistamine for itching.  No other symptoms				Y					Y	09/18/2008	12/02/2008	75		MIL	MIL	none	no	none			1						1	Pruritus; Rash papular; Scar	ANTH~UNKNOWN MANUFACTURER~~UNK~~~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0335369	12/16/2008	NY	4.6	4		M	12/12/2008	Swelling from elbow to shoulder x 2 days.									Y	12/03/2008	12/06/2008	3		OTH	OTH						1						1	Injection site swelling; Oedema peripheral	FLU3~SANOFI PASTEUR~U2803AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335370	12/16/2008	MI	8.2			F	11/07/2008	Generalized seizure/symptom 2 days post immunization with influenza vaccine.				Y					U				CT; CBC; Chem, negative; EEG, pending	OTH	OTH						1						1	Computerised tomogram normal; Convulsion; Electroencephalogram; Full blood count normal; Laboratory test normal	FLU3~SANOFI PASTEUR~U2784GA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335378	12/16/2008	MI	60.0	60		M	12/12/2008	Initial report received from a health care professional on 03 December 2008. A 60-year-old male patient received a left deltoid injection of FLUZONE SV 2008-2009 (lot number U2764AA, route of administration not reported) on 20 November 2008. The patient started having flu-like symptoms of generalized achiness and congestion that evening (onset date of events was also reported as 21 November 2008). The patient then developed chest pain that worsened over the next two-to-three days, sending the patient to the emergency room for treatment. The patient was admitted to the hospital three days after receiving FLUZONE. Length of hospitalization was also reported as three days. The patient underwent an EKG, Stress Echo and lab work of cardiac enzymes and was diagnosed with pericarditis. Treatment during hospitalization was not reported. Patient outcome was reported to be unknown. Documents held by sender: None.				Y	Y	3			U	11/20/2008	11/21/2008	1	Diagnostics included EKG, Stress Echo and cardiac enzymes; diagnosis was pericarditis.	PVT	OTH	TOPORAL XL		Medical history included hypertension and allergy to Latex. The patient had received several previous doses of FLUZONE. The following were not reported: illnesses at the time of vaccination, adverse events following prior vaccinations and other vaccines administered within four weeks of 20 November 2008.		200803879	1						1	Cardiac enzymes; Chest pain; Electrocardiogram; Influenza like illness; Pain; Pericarditis; Respiratory tract congestion; Stress echocardiogram	FLU3~SANOFI PASTEUR~U2764A~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0335390	12/16/2008	PA	36.0	36		F	12/16/2008	Malaise, fever, chills followed by slow onset of asthma (with wheezes), photophobia, conjunctivitis (with thick yellow discharge).  treated with Albuterol inhaler & Advair (spaced 3 hours apart), 2 tabs of benadryl and another 2 puffs of albuterol before bed (12am).  Symptoms resolved completely by the 8am.  Considered visiting the emergency room, but symptoms improved by the evening.  I am a medical professional- if I wasn't I would have definitely gone to the ER.									Y	11/15/2008	11/15/2008	0		PVT	UNK		None	Sulfa drugs, lanolin (contact dermatitis)			1						1	Asthma; Chills; Conjunctivitis; Eye discharge; Malaise; Photophobia; Pyrexia; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0335392	12/16/2008	WI	40.0	40		M	12/16/2008	PATIENT GIVEN HEP A/B TWINRIX INTRANASAL VICE FLU-MIST. THERE WAS NO ADVERSE REACTION TO THE VACCINE. PATIENT FOLLOWED UP THE NEXT DAY WITHOUT ANY COMPLICATIONS.  STAFF MEMBER WAS TAKEN OFF GIVING IMMUNIZATIONS AND WILL BE ATTENDING THE NEXT CLASS FOR IMMUNIZATION ADMINISTRATION.									Y	12/13/2008				MIL	MIL	NONE	NONE	NONE			1						1	Incorrect route of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500560P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB116AA~UNK~IN~NS~HEP A + HEP B (TWINRIX)~1	USA		Influenza
0335393	12/16/2008	CA		34		F	12/16/2008	Patient states after given intra nasal flu mist noted post nasal drip and eye irritation within 30 minutes after vaccine administered experienced occular pressure. Sent to the ER for med evaluation. Symptoms resolved.									Y	10/09/2008	10/09/2008	0	Examination in ED 10/09/08. Diagnosis Lacrimal duct swelling.	PUB	PVT		none known	none known			1						1	Eye irritation; Intraocular pressure increased; Lacrimal disorder; Postnasal drip	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0335395	12/16/2008	FL	4.0	4		M	12/16/2008	Pinpoint, red, flat lesions noted on face, neck,shoulder and chest.  Noted by parent soon after shots administered and she returned to office within 2 hours of shots where child seen by ARNP. No fever, not itchy, don't blanch, child appears to have no other changes. Advised monitoring, Ibuprofen, see MD if worsening of symptoms.									U	12/15/2008	12/15/2008	0		PUB	PUB		None.	None.			1						1	Rash	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B087BA~5~IM~RA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~u2849AC~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0492~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1255X~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1138X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0335396	12/16/2008	ND	57.0	57		F	12/16/2008	Pt. received flu vaccination at 1600 hrs. on 12-15-08.  At 1900 hrs. pt called nurse to say she had been coughing and felt like there was a lump in my throat, for the past 20 minutes.  Pt denied difficulty breathing. Nurse instructed her to take 2 benadryl tabs and have husband take her to ER stat.  Pt entered ER with coughing and wheezing and c/o sore throat. tachycardia @120. Tachypenia @ 24-28. Wheezes in all lung fields. Benadryl 50 mg IVP @2020 hrs. Lab tests done. Pt. had nebulizer treatment with little relief at 2000 hrs. Pt. discharged ambulatory at 2110. Medrol dose pack as directed. Push fluids.  Potassium 10mcg PO daily, Benadryl 50 mg every 4-6 hrs X 2 doses than as needed. Return if symptoms worsen. Follow-up in clinic in 1 week.				Y					Y	12/15/2008	12/15/2008	0	Potassium Low 3.1    Glucose High 171   BUN High 19    HGB, High 14.9   BA High 1.0  All other lab values within normal range.	PUB	PVT	a diuretic pill, hormone cream, baby ASA, Ca & Vit D pill, Ayur-gymnema supplement, fish oil capsule, and ginsing	None	slight allergy to cats and surgical tape.			1						1	Blood alcohol increased; Blood glucose increased; Blood potassium decreased; Blood urea increased; Cough; Haemoglobin increased; Oropharyngeal pain; Sensation of foreign body; Tachycardia; Tachypnoea; Wheezing	FLU3~SANOFI PASTEUR~U2772AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335398	12/16/2008	MO	80.0	80		M	11/06/2008	11-04-08 Legs aching then general aches, weak and dizzy.  Noon temp 105 degree F orally.  Called Dr. but unable to reach.  Called CCHD and told to use cool packs and Tylenol or ibuprofen and to go to the ER if doesn't keep temp down.  4 p.m. temp 102.4 F 2:30 p.m. Dr. called adn gave antibiotics.  11-3-08 PM able to eat.  11-6-08 still a bit dizzy and weak.  11-6-08 BP 144/69 P 88.				Y					Y	11/03/2008	11/04/2008	1		PUB	PVT	vitamins, tramanol		penicillin, aleve, codeine		MO-2008-29	1						1	Asthenia; Dizziness; Pain; Pain in extremity; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA159AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0978X~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0335399	12/16/2008	IL	1.0	1	.0	F	12/16/2008	Client's mother reported approximately 10 days after client received her immunizations that a hard, red lump appeared on client's left thigh. Client was afebrile and did not seemed bothered by the lump. Client's parents brought her into her pediatrician who had a culture completed. Culture showed staph per client's mother. Client received oral antibiotic treatment for 10 days as well as an antibiotic cream. Client has had no previous problems with any vaccinations. Received her 2nd flu 0.25 immunization on 12/12/08 and had no reaction per client's mom as of 12/16/08.				Y					Y	11/07/2008	11/17/2008	10	Cultures were completed.	UNK	UNK	None known	None	None known			1						1	Culture; Culture positive; Injection site erythema; Injection site induration; Staphylococcal infection	FLU3~SANOFI PASTEUR~UT2787DA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0985X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C40031~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1221X~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0335400	12/16/2008	CT	38.0	38		F	12/16/2008	Pt. had flu vaccine @ 4pm. Later in the evening felt she was coming down w/cold. c/o feeling short of breath and some congestion, but did not feel it warranted calling MD.  Took cold medicine and went to bed. Feeling fine today.									Y	12/15/2008	12/15/2008	0		PUB	PVT		none	none			1						1	Dyspnoea; Nasopharyngitis; Upper respiratory tract congestion	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335402	12/16/2008	OK	54.0	54		F	12/16/2008	Within 5 minutes of administering immunizations pt. reports tongue feeling swelling and numbness, heaviness in chest				Y					U	12/16/2008	12/16/2008	0		PUB	PUB	Benadryl 50mg IM		Anemia			1						1	Chest discomfort; Hypoaesthesia oral; Immediate post-injection reaction; Swollen tongue	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~U980X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0335404	12/16/2008	NJ	3.0	3		M	12/16/2008	Within 14 hours of receiving flu shot, pt awoke with severe red, swollen, itchy hives from head to toe.				Y					N	12/15/2008	12/16/2008	1		UNK	UNK	Tylenol	none	none	none~ ()~~0.00~In Patient|none~ ()~~0.00~In Sibling		1						1	Erythema; Pruritus; Swelling; Urticaria	FLU3~SANOFI PASTEUR~U2804AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335405	12/16/2008	CT	74.0	74		M	12/16/2008	Pt received the shingles vaccine on 11/25/08 for a routine f/u visit.  On 12/10/08, pt called clinic reporting a painful rash to chest and back since 12/6/08.  During urgent visit appt, pt noted to have vesicular rash in T4 dermatome of L chest and back and biopsy taken which was positive (VZV detected).				Y					Y	11/25/2008	12/06/2008	11	Biopsy sample taken which was positive	UNK	UNK	asa 81mg, AMLODIPINE BESYLATE 10mg, CHLORTHALIDONE 12.5mg, CLOPIDOGREL 75MG, CYANOCOBALAMIN (B12) 1000MCG, GLYBURIDE 5MG BID     LISINOPRIL 40MG, Metformin 1g BID, METOPROLOL TARTRATE 50MG BID, NAPROXEN 250MG BID, NIACIN (NIASPAN) 500MG SA	none	1. DM 2. CAD s/p MI early 90s, stent to marg  1/04, stent to lad 3/04; last cath 2/08 3. HTN 4. hx CVA 2001 - lacunar 5. s/p cataract surgery 6. glaucoma 7. atrophic R kidney 8. b12 deficiency 9. BPH 10. barrett's 2007 -> repeat 2010			1						1	Biopsy skin abnormal; Pain; Rash; Rash vesicular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA181AA~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|VARZOS~MERCK & CO. INC.~1418X~2~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0335408	12/16/2008	UT	52.0	52		F	12/16/2008	She reports she had right arm pain the day following the injection (the arm she received the injection. She reports progressive worsening pain. Unable to use arm with lifting and certain movements. First saw a physician on 12/15/08.									N	11/17/2008	11/18/2008	1		UNK	UNK	for thyroid, pituetary gland, and migrane headaches	None.......PLEASE NOTE QUESTION 14 SHOULD BE NO OTHER VACCINATIONS WITHIN 4 WEEKS TO EVENT SHOULD BE BLANK; I AM NOT ABLE TO DELETE THIS ENTRY.	Thyroid disorder, pituetary gland disorder, and migrane headachs	None~ ()~NULL~~In Patient|None~ ()~NULL~~In Sibling1|Sister had an adverse reaction to XRay dye~ ()~NULL~~In Sibling2		1						1	Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2849AC~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335420	12/16/2008	MN	58.0	58		F	12/09/2008	Within 2 hrs. after I had the shot, I had tingling on my left side.  I thought it would go away.  I went to the hospital the next morning & the MRI showed I had a stroke.  12/26/2008 MR received for DOS 11/15-16/2008 with D/C DX: Partially reversible ischemic neurologic deficit.  Esophageal reflux.  Iron deficiency anemia.  Hyperlipidemia. Pt presented to ER with c/o numbness and tingling on the L side of body which began several hours after receiving flu shot.  Neuro exam (+) for L sided paresthesia of arm, leg, face. Started on Plavix and ASA to be f/u as outpt.  02/01/2010 Follow-up: I have neuropathy (numbness) in the left hand and foot. Also some weakness in left arm and sometimes a fuzzy slight numbness in left chest area. The neuropathy causes me pain. Also I have loud ringing in my ears constantly.				Y	Y	2		Y	N	11/14/2008	11/14/2008	0	MRI at hospital. Labs and Diagnostics:  Echo (-).  Carotid US (-) for stenosis, (+) for minimal plaque.  Head CT (-). ECG WNL.	OTH	PVT	NEXIUM	None	Betadine. PMH:  Hyperlipidemia. Reflux			1						1	Asthenia; Iron deficiency; Nuclear magnetic resonance imaging abnormal; Pain; Paraesthesia; Tinnitus	FLU3~SANOFI PASTEUR~U2831AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0335422	12/16/2008	FL	75.0	75		M	12/13/2008	The day following vaccination, I experienced very sore throat and worst cough I can recall in past 30 years. Three days later I called the vaccine provider and was told that my symptoms could not have come from vaccines and must be coincidental cold. Sore throat subsided, but cough continued and even got worse. No serious fever -- maximum 100-101 deg F. After suffering for 10 days, I finally saw a doctor (11/17/08) who said I did not have either pneumonia or pleurisy and gave Rx for Azithromycin. He said pain in chest muscles was due to strain of coughing so hard. Cough cleared after 5 days, but pain in chest continued and became more severe. On 12/3/08, I saw same doctor again. Pain has gradually diminished during past 10 days, and 12/10 was first day I felt I could resume most of my normal activities. Still have twinges of pain in rib cage and shoulder blades with any quick motion. I have had mild chronic bronchitis for many years, but have never experience anything like the past 5 weeks. It may have been just coincidence, but I will never risk having another pneumonia or flu vaccination.				Y					N	11/06/2008	11/07/2008	1	Chest x-ray; EKG; blood tests - all normal	OTH	OTH	CENTRUM Multi Vitamin	None	None			1						1	Blood test normal; Body temperature increased; Chest X-ray normal; Chest pain; Cough; Electrocardiogram normal; Oropharyngeal pain	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1541U~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0335424	12/16/2008	CO	54.0	54		F	12/15/2008	Patient complained that injection site still very sore after 6 weeks.									U	11/02/2008	11/02/2008	0		OTH	OTH	Fosanax; Oracea; Viuelle Dot		Penicillin			1						1	Drug hypersensitivity; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89985~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0335425	12/16/2008	MT	28.0	28		F		Pt. received Japanese Encephalitis vaccine and developed acute nausea within 1/2 an hour. No other anaphylactic symptoms.									Y	12/10/2008	12/10/2008	0	None	MIL	MIL	None	None	None			1						1	Nausea	FLU3~CSL LIMITED~01649111A~2~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|JEV~SANOFI PASTEUR~EJN236A~1~SC~RA~JAPANESE ENCEPHALITIS (JE-VAX)~1	USA		Influenza
0335427	12/16/2008	PA	25.0	25		F	12/10/2008	Local reaction Myalgias, Fatigue, headache									U	12/08/2008	12/09/2008	1	None	OTH	OTH	OCP/PROTONIX; LEXOPRO; AMBIENCE CR					1						1	Fatigue; Headache; Local reaction; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0335429	12/16/2008	GA	5.0	5		M	12/11/2008	Local reaction on right arm where shot was administered.  Redness, swelling & heat.  Pt. denied pain, itching.									Y	12/09/2008	12/11/2008	2	n/a	PVT	PVT	None	None	None			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Local reaction	FLU3~SANOFI PASTEUR~U2764AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335431	12/16/2008	UT	65.0	65		U		Low grade temp, swelling @ injection site within 2 hours.  Temp & swelling resolved but, persistent pain & tenderness @ site of infection with decreased ROM.									N	10/08/2008	10/08/2008	0		PVT	UNK						1						1	Body temperature increased; Injected limb mobility decreased; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2756AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335432	12/16/2008	MI	12.0	12		F	12/03/2008	Low grade fever, 100.4, started 12-1-08 lasting 36 hrs.  Injection site reddened and raised, half dollar size per mother.  Painful to move arm.									U	12/01/2008	12/01/2008	0		PUB	PUB					M12008031	1						1	Injection site erythema; Injection site swelling; Pain in extremity; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~1216X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0335433	12/16/2008	PA	71.0	71		F	10/27/2008	11-22-08 Client states left upper arm wasosore & painful about 48 hrs after injection.  Afebrile.  Client applied ice initially.  Took TT TYLENOL.  10-23-08 client reports arm improved.  10-26-08 client feels fine.									Y	10/17/2008	10/19/2008	2	None	UNK	UNK		None	Hypertension, Hyperlipidemia			1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2751AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335435	12/16/2008	PA	73.0	73		M	11/17/2008	Consumer reports injections site started with redness and rash approx. 4-6 hours after injection. Not reported to anyone until 11-14-08. RN visited and reported to doctor - 9 cm x 9 cm red rash surrounding injection site and site tender to touch. Doctor ordered BENADRYL and TYLENOL.									Y	11/03/2008	11/03/2008	0		OTH	OTH	Glyburide; Allopurinol; Spironolactone; Furosemide; Metformin; LOPRESSOR		DARVON; Codeine			1						1	Injection site erythema; Injection site pain; Injection site rash	FLU3~SANOFI PASTEUR~U2751AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335436	12/16/2008	OH	35.0	35		F	11/11/2008	Patient became tired within 1-2 hours of vaccine. itching started approximately 4-5 hours later under chin and got worse through out evening resulting in red patch. Next day patch larger and spreading to neck (front and back), scalp, chest, shoulders and forehead. Accompanied by nausea and trouble breathing +fever +chills by day 3 went to urgent care day 3 for steroid shot (unknown name) MEDROL dose pack, steroid cream (unknown) names and BENADRYL 25mg. Meds relieved reaction but took about 9-10 days to do so. Patient now fully relieved as of 12/3/08.				Y					Y	11/02/2008	11/02/2008	0		OTH	PVT		None	None			1						1	Chills; Dyspnoea; Erythema; Fatigue; Nausea; Pruritus; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500563P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0335437	12/16/2008	MN	20.0	20		F	12/10/2008	Received shot 12-5-08.  Patient reports she noticed pain on eve of 12-05-08.  She called nurse line 12-6-08- applied cold with relief.  Called nurse line 12-7-08 - applied heat with relief.  Called doctors office 12-10-08 and we made appt to see her same day.  Site 12-10-08 @ 17:30 is warm, sis cm X 4 cm induration, erythemia central puncture lesion scabbed over.  Temp = 36.8 degrees C.  Tx= cold compress tib + prn for comfort.  Call for increased swelling & pain.				Y					N	12/05/2008	12/05/2008	0	None performed.	PVT	PVT	FLUCOMAZOLE, ALBUTERAL, AZITHROMPIN, TYLENOL PM.	Yeast infection (vaginal) hx: congenital HSV	Topical Sulfa			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site scab; Injection site warmth	FLU3~SANOFI PASTEUR~U2803AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C3027BA~1~IM~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0335438	12/16/2008	IL	0.7	0	.7	M	12/11/2008	Fever to 104.6 at the night pt had received vaccines.				Y					Y	10/20/2008	10/20/2008	0	12.8> 11.5 58P 35L 2B  UA -  BC, UCX -	PVT	PVT	None	None	None			1						1	Culture urine negative; Pyrexia; Urine analysis normal; White blood cell count increased	DTAPIPVHIB~SANOFI PASTEUR~C2900AA/C3176AA~1~IM~UN~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~UT2782FA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C86139~3~IM~UN~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0335440	12/16/2008	AL	50.0	50		F	12/10/2008	Rec'd call from patient 12/8/08 who relates that she rec'd flu shot 10/15/08 and shot was given in left deltoid. She experienced typical pain at time shot was given and (3) days later experienced a cramping aching pain. Arm was warm to touch for 2-3 days. She went to her MD on 11/21/08 who prescribed medication for inflammation and nerve pain. Relates arm is still painful and radiates to fingers.				Y					U	10/15/2008	10/18/2008	3		PUB	UNK		None	Sulfar drugs; Avelox; had reaction to steroids; hypertension			1						1	Inflammation; Injection site pain; Neuralgia; Pain in extremity; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA349CD~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0335441	12/16/2008	AZ	41.0			F	12/10/2008	Received Flu shot and returned 45 min later - injection site showing white hive on flank R A - complained of itchy palms, client states she gets hives frequently unsure if flu shot was the cause. Unable to take BENEDRYL - Client referred to ER, unable to reach client.				Y					U	11/24/2008	11/29/2008	5	Unknown	PUB	PVT	Unknown	None	Unknown			1						1	Injection site urticaria; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA181AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0335442	12/16/2008	TX	11.0	11		F	12/10/2008	Patient complain of dizziness, eye itchy, nauseated, doesn't feel well, fatigue and sleeping more.									U	12/09/2008	12/10/2008	1		PVT	PUB		dealt step	ADD			1						1	Dizziness; Eye pruritus; Fatigue; Malaise; Nausea; Somnolence	FLU3~SANOFI PASTEUR~U2742AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1758U~1~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0335444	12/16/2008	MI	51.0	51		F	12/10/2008	Patient states that soreness began a few days after vaccination. She states that soreness persists three weeks after vaccination. Patient states that she has difficulty sleeping due to soreness.									U	11/10/2008	11/12/2008	2		UNK	UNK						1						1	Insomnia; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89971~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0335449	12/16/2008	IN	4.0	4		F	12/09/2008	Site was inflamed, red and hot to the touch, pain. Was put on amoxicillin, prednisone and TYLENOL with codeine.				Y					Y	12/05/2008			Allergic reaction to DTaP vaccine	PVT	PVT	None	None	Constipation; stuttering; speech delay; allergic to ZITHROMAX			1						1	Hypersensitivity; Injection site erythema; Injection site inflammation; Injection site warmth	DTAP~SANOFI PASTEUR~C2951BA~5~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2791DA~5~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB260AA~1~IM~LL~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~AO836~4~IM~LL~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0335452	12/16/2008	WI	10.0	10		F		11/4/08 School nurse & family called with complaints of red, swollen right arm in area where chickenpox vaccine given.  Site was red, raised & 8 cm in diameter per school nurse.  Family states child had fever the evening of 11/13/08 but no pain at site.  Child's fever resolved the next day.  11/18/08 Site was resolving-pink and 1/2 the size per school nurse.									Y	11/12/2008	11/14/2008	2	Vaccine was adjusted exp. date for breach in temp. control - from another agency.  (Varicella exp from later date to 12/22/08).	PUB	PUB	None	None	None noted			1						1	Injection site erythema; Injection site swelling; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500547P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~0088X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0335457	12/16/2008	LA	43.0	43		F	12/09/2008	Patient reported that she had a seizure within 15 minutes of receiving the flu shot.  She has a history of seizures/epilepsy.									Y	11/16/2008	11/16/2008	0	None	OTH	PUB	Unknown	None reported	Epilepsy			1						1	Condition aggravated; Convulsion; Immediate post-injection reaction	FLU3~SANOFI PASTEUR~U2848AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335458	12/16/2008	OR	5.0	5		M	12/10/2008	Raised red rash weit on upper right thigh near injection site. Four inches in diameter 12/09/2008. grew to about 4 1/4 inches on 12/10/2008				Y					U	12/08/2008	12/09/2008	1		PVT	UNK			Asthma			1						1	Erythema; Rash; Urticaria	DTAP~SANOFI PASTEUR~U2356BA~5~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2898FA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A1060~3~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0904X~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0335459	12/16/2008	TN	0.5	0	.5	F	12/09/2008	While feeding whole body shook for 20 sec on 12/5/08.									Y	12/02/2008	12/03/2008	1	None	PVT	PVT		vaginal adhesions	None			1						1	Tremor	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B201AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2782BA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF517AB~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C71975~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1268X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0335460	12/16/2008	IL	73.0	73		U		Swelling on the site of injection right after the injection.									Y	12/09/2008	12/09/2008	0		OTH	OTH	Aspirin					1						1	Immediate post-injection reaction; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89999~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0335462	12/16/2008	NC	3.0	3		M	12/09/2008	IM vaccine of INFLUENZA administered intra-nasally.									Y	12/02/2008	12/02/2008	0		OTH	OTH		Asthma	Asthma; Eczema			1						1	Incorrect route of drug administration	FLU3~SANOFI PASTEUR~UT2797EA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335464	12/16/2008	MI	7.0	7		M	12/11/2008	Puritic raised red papular rash also with 3-4 raided red welt-like lesions over right deltoid, shoulder, upper back and chest.									Y	12/03/2008	12/03/2008	0		PVT	PVT						1						1	Erythema; Rash papular; Rash pruritic; Urticaria	FLU3~SANOFI PASTEUR~U2806AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335465	12/16/2008	NC	62.0	62		M	12/11/2008	Pt called office stating on 11-14-08 left deltoid area swollen, red, warm to the touch.									Y	11/13/2008	11/14/2008	1		PVT	PVT	Celebrex (200mg CAP); Effexor XR; Plavix; Norvasc; Vytorin; Levitra; Tricor; Nitroglycerin; Zestril; Atenolol; Vitamin B12; Viagra; Folic Acid; Aspirin	None	CAD; hyperlipdemia; ED			1						1	Erythema; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U2811AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0867X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0337868	12/16/2008	OH	0.6	0	.6	F	12/01/2008	Information has been received from a nurse concerning an 8 month old female who on 11-DEC-2007 was vaccinated with her third dose of COMVAX (Lot #0377U/Batch #657380) intramuscularly in the left thigh. Her second dose was received on 02-JUL-2007 intramuscularly in the left thigh (same lot and batch number). Concomitant therapy included influenza virus vaccine (unspecified), PREVNAR and TYLENOL. On 11-Dec-2007 the patient developed redness and swelling at the injection site. Patient's illnesses at the time of vaccination were an upper respiratory infection with nasal congestion and cough. Further information is not expected.									U	12/11/2007	12/11/2007	0	None	PVT	OTH	TYLENOL	Upper respiratory tract infection; Nasal congestion; Cough			WAES0712USA06317	1						1	Injection site erythema; Injection site swelling; Chest X-ray; Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HBHEPB~MERCK & CO. INC.~0377U~3~IM~LL~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~~UNK~UN~UN~PNEUMO (PREVNAR)~1|HBHEPB~MERCK & CO. INC.~0377U~2~UN~UN~HIB + HEP B (COMVAX)~2	USA		Influenza
0337868	12/16/2008	OH	0.6	0	.6	F	12/01/2008	Information has been received from a consumer and follow-up information from a physician concerning a 7 month old female with a upper respiratory infection at time of vaccination, no pertinent medical history, drug reactions/allergies who on 11-DEC-2007 (also reported as 2-Jul-2007) was vaccinated in the left thigh (route not reported) with a second dose of COMVAX (lot #657380/0377U).  There was no concomitant medication usage.  On 11-DEC-2007, post vaccination, the patient developed tenderness, slight swelling and redness at the injection site.  Per the patient's mother, this had never happened with previous shots.  The patient did have a chest x-ray done (results not reported).  The patient did not receive medical attention.  The patient began to recover on 12-Dec-2007.  No additional information is expected.									Y	12/11/2007	12/11/2007	0	Chest X-ray	PVT	OTH	None	Upper respiratory tract infection	None		WAES0712USA06248	1						2	Injection site erythema; Injection site swelling; Chest X-ray; Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HBHEPB~MERCK & CO. INC.~0377U~3~IM~LL~HIB + HEP B (COMVAX)~1|PNC~PFIZER\WYETH~~UNK~UN~UN~PNEUMO (PREVNAR)~1|HBHEPB~MERCK & CO. INC.~0377U~2~UN~UN~HIB + HEP B (COMVAX)~2	USA		Influenza
0335454	12/17/2008	WI	11.0	11		F		11/13/2008 phone call from mother concerned about swollen, red arm.  Ice was applied to site.  Area red/swollen on lower part of arm 11/14/08 mom states area of redness reduced to size of golf ball now.									Y	11/11/2008	11/13/2008	2	Chickenpox vaccine had an adjusted expiration date due to breach of temp control.  Received vaccine from another health department and adjusted exp date 12/22/08	PUB	PUB	None	None	None			1						1	Erythema; Oedema peripheral	FLUN3~MEDIMMUNE VACCINES, INC.~500547P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U2567AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B018BA~1~ID~LA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~0088X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0335493	12/17/2008		44.0	44		M	12/15/2008	I received a flu shot at approx 10:30 am on 12/12/2008. By approx 5:00PM I was very nauseous - by 8PM I was suffering from diarrhea, horrible sulfer - egg - smelling burping and gas, as well as coughing and some mild vomiting. I also am suffering from weakness and soreness - cannot sleep for more than 2 hrs at a time from above conditions. Still persisting as of 5 AM 12/15/2008. The only food I can keep down is toast and butter,k and it is quickly eliminated.										12/12/2008	12/12/2008	0		UNK	UNK			I am allergic to PENNICILLIN, will sometimes have a mild reaction to eggs - diarrhea and gas. I also suffer from Parkinsonism and osteo arthritis in my joints.			1						1	Asthenia; Cough; Diarrhoea; Eructation; Flatulence; Insomnia; Nausea; Tenderness; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0335495	12/17/2008	PA	45.0	45		F	11/24/2008	Received HAVIX, 1.0ml in left deltoid at 2:15pm and FLUVIRIN 0.5ml in right deltoid approx. 2:20pm.  At 2:35pm patient reported feeling faint , anxious and a little tightness in my chest, vital signs: BP 140/60 sitting, radial pulse 100, respirations 20 breath sounds clear. 911 call initiated at 2:40pm, nursing supervisor and district nurse manager notified.  EMS arrival at 2:50pm, EMS Departure 3:05pm.  Pt remained alert and oriented throughout incident.				Y					Y	11/24/2008	11/24/2008	0	None	PUB	PUB		None	Past history 2004 of benign meningioma			1						1	Anxiety; Chest discomfort; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89976~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB236AA~1~IM~LA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0335497	12/17/2008	UT	51.0	51		F	12/08/2008	Approx 12hrs after pneumonia vaccine was given to me in (L) arm, it began to swell, and it was very tender to touch and mottling. I had a temperature that would come and go- at one point it reached 102.5. Body chills and achiness that were unexplained. These signs and symptoms lasted for about 4 days and loss of work.									Y	11/06/2008	11/06/2008	0		PUB	PVT		None	None			1						1	Activities of daily living impaired; Body temperature fluctuation; Chills; Livedo reticularis; Pain; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U2772AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0224X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0335498	12/17/2008	MD	45.0	45		F	11/19/2008	Flu shot was given around 1:45 AM and at 5:30 PM, began having itchy, swollen eyes, swollen throat with difficulty breathing. Pt. stated she took Tobamax in the AM and IMITRIX that evening. POA headache, she stated she had a hamburger and lemonade prior to shot and only H2O after. Pt. wanted to sleep so she took Nyquil. This AM still had  itchy eyes with some swelling. Pt. stated had any appt. with Dr. today.									Y	11/18/2008	11/18/2008	0		OTH	OTH	See # 7		An autoimmune issue and a glutenin allergy			1						1	Dyspnoea; Eye pruritus; Eye swelling; Headache; Pharyngeal oedema	FLU3~SANOFI PASTEUR~U2749AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335499	12/17/2008	IN	4.0	4		F	12/10/2008	Pt  received FLUMIST.  Epistaxis noted after administration of FLUMIST.  Pressure applied immediately.  Bleeding stopped in minutes.  Pt examined per physician.									Y	12/10/2008	12/10/2008	0	None	PVT	PVT	None	No	None			1						1	Epistaxis	DTAP~SANOFI PASTEUR~C2999AA~5~IM~LL~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500585~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~A1229~4~IM~RL~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0335500	12/17/2008	NY	1.3	1	.3	F	12/12/2008	Child developed diffusely spread mildly puriutic papular rash over entire body.				Y					Y	12/01/2008	12/12/2008	11	None	PVT	PVT		None	None			1						1	Rash generalised; Rash papular; Rash pruritic	FLU3~SANOFI PASTEUR~U2792AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UT2792DA~4~IM~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0915X~1~IM~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1189X~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0335502	12/17/2008	MI	52.0	52		F	12/17/2008	Within a couple of hours of vaccination, patient began to experience throat pain and swelling, pruritis, fever/chills, and nausea/vomiting.  Over the course of a couple of hours, the symptoms subsided a little; patient was treated with Benadryl.				Y					Y	12/16/2008	12/16/2008	0		PVT	PVT	Allegra, Sudafed, Prozac, Iron supplement, multivitamin, famotidine, mucinex, aldara	none	NKMA, Depression, environmental allergies			1						1	Chills; Nausea; Oropharyngeal pain; Pharyngeal oedema; Pruritus; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~V2751aa~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C3031aa~1~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0335504	12/17/2008	MA	4.0	4		M	12/17/2008	My son had a chicken pox and flu vaccine given in the same arm on thursday December 11th. On the 12th his shoulder was swollen and was hurting, I put some ice on it. On the 13th the swelling got worse. It felt leathery,hot and it was red. The swelling also started heading down to the elbow, so I called the Dr. who told me to put some ice on it and give him some pain medication and some Benadryl, and watch it for 48 more hours more. I gave him the Benadryl only and this helped with the itching a little, he was still able to move his arm and I felt his brachial and radial pulses, so that made me a little more comfortable. The swelling continued on the 14th and was now at his elbow and was itching. The swelling in his arm was 2 times the size of his other arm. It was still hot. I gave him another dose of the Benadryl and fluids to drink. On Monday while I was getting ready to take him to the doctor, the swelling in his arm was the same size a little hot, but the leathery feeling was less. I didn't take him in. Today the 17th the swelling is all gone except a little bit near his shoulder and some itching last night.									Y	12/11/2008	12/13/2008	2		UNK	UNK		my son had some coughing	none. i am unable to tell lot number and manufacturer, the clinic would have this info			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site pruritus; Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~0~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~0~2~IM~RA~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~0~2~IM~LA~VARICELLA (NO BRAND NAME)~1	USA		Influenza
0335505	12/17/2008	SC	4.0	4		M	12/17/2008	Fever, Swelling, itchiness, and infection around injection site. treated with antibiotics				Y					Y	12/15/2008	12/16/2008	1		MIL	MIL			Autism			1						1	Injection site infection; Pruritus; Pyrexia; Swelling	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B103AB~5~IM~RA~DTAP + IPV (KINRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500562P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~MERCK & CO. INC.~0482X~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1177U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0335506	12/17/2008	IN	60.0	60		F	12/17/2008	States last evening suddenly felt like throat was closing up, difficulty breathing and swollen eyes.  Episode lasted approximately 3-4 hours.  Today, 12 hours later, her eyes are still somewhat puffy but no other problems.  Did not seek medical attention but did take some Benedryl.									Y	12/16/2008	12/16/2008	0	No prior history of chicken, egg, or thimerosol allergies or reactions.  Did eat a bowl of chicken rice soup just prior to her episode that a neighbor brought over to her.  She thought perhaps there was something in the soup she was allergic to.	PUB	PVT		None				1						1	Dyspnoea; Eye swelling; Throat tightness	FLU3~SANOFI PASTEUR~U2765AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335507	12/17/2008	MI	11.0	11		F	11/26/2008	Patient c/o an increase in asthma related symptoms after receiving FluMist.  Her parent reported the symptoms to the clinic on 11/26/08.  She was scheduled for an appointment, examined, and treated for allergy and asthma related symptoms on the same day.				Y					Y	11/13/2008			Examination only.	PVT	PVT		None	Mild intermittent asthma			1						1	Asthma; Condition aggravated	FLUN3~MEDIMMUNE VACCINES, INC.~50058p~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0335518	12/17/2008	NH	52.0	52		M	12/17/2008	Pt requested to be seen on an urgent basis for a rash that started two  days ago after his flu shot.  Pt. states he had a flu shot last week and after that he developed a rash all over his body. He says there is a big red blotch where he got the  shot. He says it is on his shoulders, neck and legs.				Y					Y	10/21/2008	10/23/2008	2		PUB	PUB	thiamine 100mg, ranitidine 150mg, mag oxide 400mg, levothyroixne 0.088mg, lisinopril 5mg	none	hypertension, hypothyroidism esophageal reflux			1						1	Injection site erythema; Rash generalised	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA181AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0335522	12/17/2008	CA	21.0	21		M	12/17/2008	Patient's father called 2 hours after patient received Hepatitis A, Tdap (Adacel), Influenza, and Yellow Fever stating patient was experiencing itchiness, hives and difficulty breathing. Patient was instructed that if available, to take Benadryl and to go immediately to the Emergency Room. On follow up phone call 12/17/2008, patient stated that the onset of symptoms was 45 minutes after receiving vaccines. Patient stated that when he left the hospital around 3 pm on 12/16/2008, that he felt perfectly normal and that he continues to feel healthy. Patient stated he received IV fluids, he thinks Benadyrl and Epinephrine. The ER gave him prescriptions for Prednisone and Diphenhydramine hydrochloride.				Y					Y	12/16/2008	12/16/2008	0		PVT	PVT	NONE REPORTED BY PATIENT	NONE REPORTED BY PATIENT	NONE REPORTED BY PATIENT			1						1	Dyspnoea; Pruritus; Urticaria	FLU3~CSL LIMITED~00849211A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB251BA~UNK~IM~RA~HEP A (HAVRIX)~1|TDAP~SANOFI PASTEUR~C2865AA~UNK~IM~LA~TDAP (ADACEL)~1|YF~SANOFI PASTEUR~UF428AA~UNK~SC~LA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0335524	12/17/2008	OR	80.0	80		M	12/17/2008	Patient experienced a herpes outbreak after flu shot. Patient took acyclovir and felt better. ACYCLOVIR 800MG TAB TAKE ONE-HALF TABLET BY MOUTH THREE TIMES A DAY FOR 10 DAYS.				Y					Y	10/07/2008	10/14/2008	7		UNK	UNK	lisinopril, nifedipine, simvastatin, nitroglycerin, dyazide, MVI, goserelin, asa,	none	HTN-CAD-Hyperlipidemia-Prostate cancer-Osteoporosis-DJD-Lumbar spine   Abdominal aortic aneurysm-			1						1	Herpes virus infection	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA184AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0335534	12/17/2008		76.0	76		F	12/17/2008	This case was reported by a consumer and described the occurrence of Guillain-Barre in a 76-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other healthcare professional has not verified this report. Concurrent medical conditions included gas and high cholesterol. Concurrent medications included PREVACID and LIPITOR. On 12 November 2008, the subject received unspecified dose of FLULAVAL (intramuscular, unknown). On 26 November 2008, 14 days after vaccination with FLULAVAL, the subject experienced feeling weak, could not walk. On 01 December 2008, the subject was diagnosed with Guillain-Barre. At an unknown time after vaccination with FLULAVAL the subject had numbness (hands and legs) and was nonresponsive. The subject was hospitalised. The subject was treated with normal immunoglobulin (IVIG). The daughter of a female subject reported that her mother received an immunization of FLULAVAL on 12 November 2008. On 28 November 2008, the subject reported feeling weak, and had difficulty walking. During the period of 26 November 2008 to 01 December 2008, the subject's symptoms had become worse. On 01 December 2008, the subject was hospitalized. A diagnosis of Guillain Barre syndrome was made. The subject received IVIG and is still unresponsive. At the time of the report, the subject remained hospitalized. At the time of reporting the events were unresolved.  2/2/09 Received hospital medical records of 12/1-1/20/2009. FINAL DX: Guillain Barre syndrome s/p IVIG & plasmapheresis; left shoulder rotator cuff tear. Records reveal patient experienced ascending LE weakness & paralysis & RUQ abdominal pain x 4-5 days.  Had similar symptoms 14 yrs prior that responded to outpatient steroids.  Neuro consult done.  Tx steroids initially then, w/IVIG w/minimal improvement then plasmapheresis x 2.5 weeks.  Initially HTN tx w/meds & diuresis.  Became hypotensive w/plasmapheresis, antiHTN meds d/c. Developed thrombocytopenis due to DVT prophylaxis & meds changed.   Developed low grade fever & ID consult done.  Tx w/IV antibiotics for possible early cellulitis.  Tx w/PT/OT & transferred to inpatient rehab & continued to be followed by neuro.   Improved & d/c to home w/continued PMR & Neuro f/u.				Y	Y	51			N	11/12/2008	11/26/2008	14	UNK  LABS: CBC, UA,  & chemistry WNL except sodium 147.  Amylase (H), lipase 27(N).  LFTs (H).  Abdominal US revealed fatty liver.  CXR abnormal w/atelectasis.  CSF: protein 96(H), glucose 58(N), IgG 9.6(H), albumin 68.1(H).  HSV1 & HSV2 IgG (+), IgM (-).CMV IgG(+), IgM(_-).  CT scan, LP. MRI left shoulder abnormal w/c-spine DDD & rotator cuff tear.   EMG/NCS abnormal & c/w GBS.	OTH	OTH	Lansoprazole; Atorvastatin calcium	GAS; High Cholesterol	PMH: Multiple prior flu shots w/o problems except 14 yr prior w/similar symptoms.  Shingles, distant hx of DVT, hyperlipidemia, carcinoma in situ of breast w/lumpectomy & rad tx in 2005, insomnia, impaired mobility & self care.		A0760577A	1						1	Abasia; Asthenia; Blood product transfusion; Gait disturbance; Guillain-Barre syndrome; Hypoaesthesia; Unresponsive to stimuli	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA159AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation	Influenza
0335543	12/17/2008	FL	1.0	1	.0	M	12/17/2008	Rash at injection site s/p 9d.				Y					U	12/05/2008	12/14/2008	9		PVT	PUB	None	Well	None			1						1	Injection site rash	FLU3~SANOFI PASTEUR~UT2783DA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB327BA~1~IM~RL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~D03723~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1286X~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0335544	12/17/2008	WI	51.0	51		F	12/17/2008	1) Swelling and erythema 4 cm x 3 cm of left deltoid. Pain after 5 days. Ibuprofen and ice.									U	12/12/2008				OTH	OTH						1						1	Erythema; Pain; Swelling	FLU3~SANOFI PASTEUR~U2752AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C3031AA~1~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0335546	12/17/2008	PA	12.0	12		F	12/13/2008	Pt. had dizziness and nausea after vaccination. Had pallor and diaphoresis. Vital stable. CNS exam. WNL. Referred to ER for eval.				Y					Y	12/13/2008	12/13/2008	0		PVT	OTH						1						1	Dizziness; Hyperhidrosis; Nausea; Pallor	FLU3~SANOFI PASTEUR~U2833AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0575X~UNK~UN~LA~HPV (GARDASIL)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AL52B029AA~UNK~UN~RA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~0790X~UNK~UN~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0335547	12/17/2008	WA	0.6	0	.6	F	12/17/2008	redness in bilateral thigh, fever, very irritable, cranky. The next morning after being given vaccine.									U	12/16/2008	12/17/2008	1		PVT	OTH						1						1	Injection site erythema; Irritability; Pyrexia	DTAP~SANOFI PASTEUR~C3240AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2794CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~C3240AA~3~IM~LL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~C3240AA~3~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~C22283~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0335549	12/17/2008	WA	7.0	7		M	12/17/2008	Started with itching, then hives on arms, legs and abdomen. Given BENADRYL.									U	12/17/2008	12/17/2008	0		PVT	PUB	BENADRYL after reaction	None				1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2928AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335550	12/17/2008	AZ	54.0	54		M	12/16/2008	Erythematous plague at injection site. Disseminated erythematous Pruritic plague (20 over trunk, upper arms). Persisted for weeks. Patient self treated with hydrocortisone 1% topical.									Y	10/07/2008	10/14/2008	7	None	PUB	PUB	PROBENECID; VIAGRA; HCTZ; DILTIAZEM; PRAZOSIA; BENAZEPRIL; COLCHICINE; METOPROLOL					1						1	Injection site erythema; Rash erythematous; Rash pruritic; Skin plaque	FLU3~SANOFI PASTEUR~U2764AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335551	12/17/2008	AZ	16.0	16		M	12/17/2008	Patient administered FLUMIST vaccine 11/14/2008 via nasal route. Only vaccine given. Developed Urticaria about 3 hours later.				Y					Y	11/14/2008	11/14/2008	0	None	PUB	PUB	MAPIROCIA	Paronychia, toe	Eczema			1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500576P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0335555	12/17/2008	CA	3.0	3		M	12/17/2008	7 x 6 of  erythematous, some pain, Right thigh									U	12/15/2008	12/16/2008	1		OTH	OTH		None	obese			1						1	Injection site erythema; Injection site pain	DTAP~GLAXOSMITHKLINE BIOLOGICALS~U2787EA~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UC14B066AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB247AA~1~IM~LL~HEP A (HAVRIX)~1	USA		Influenza
0351862	12/17/2008	LA	26.0	26		F	12/17/2008	Pt. called health unit to report eyes red, cough/stopped, approximately starting one hour after vaccines administered. Instructed to report to E.R. for evaluation.									U	12/17/2008	12/17/2008	0		PUB	PVT	None	None				1						2	Cough; Ocular hyperaemia; Cough; Ocular hyperaemia; Respiratory tract congestion	FLU3~SANOFI PASTEUR~U2848AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|TDAP~SANOFI PASTEUR~C3027AA~1~IM~LA~TDAP (ADACEL)~2|FLU3~SANOFI PASTEUR~U2848AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|TDAP~SANOFI PASTEUR~C3027AA~1~IM~LA~TDAP (ADACEL)~3	USA		Influenza
0333721	12/18/2008	VA	67.0	67		F	12/01/2008	11/12 c/o cold symptoms. 11/13 cold symptoms went away developed double vision & weakness when walking to ER. Hospitalized slurry speech inability to walk vision worse tap dx Guillain Barre. Transferred to neuro at hosp. Tx IgG started to reverse 11/20 +/- maximum assistance needed. 11/25 transferred to rehab. 1/29/2010 Residual ataxia and diplopia.			Y		Y	13			Y	10/20/2008	11/13/2008	24	spinal tap	OTH	OTH			hypertension			1						2	Asthenia; Blood product transfusion; Computerised tomogram abnormal; Cough; Diplopia; Gait disturbance; Guillain-Barre syndrome; Miller Fisher syndrome; Nerve conduction studies abnormal; Nuclear magnetic resonance imaging normal; Upper respiratory tract infection; Vision blurred; Abasia; Asthenia; Ataxia; Blood product transfusion; Diplopia; Diplopia; Dysarthria; Guillain-Barre syndrome; Lumbar puncture; Nasopharyngitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88636~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88636~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Life Threatening,Hospitalisation	Influenza
0335573	12/18/2008	NM	4.0	4		F	12/12/2008	Gave vaccination, child's leg had a reaction that evening. Went to ER and was hospitalized for two days.  2/2/09 MR received for DOS 12/9-11/2008 with D/C DX:  L thigh cellulitis. Pt presented with 1 day hx of swelling and erythema of the L thigh following vaccines given on 12/8/08.  Swelling and redness noted below the knee. Leg is tender and pt favoring when walking.  Tx with abx and Benadryl with resolution.					Y	2			Y	12/08/2008	12/08/2008	0	Labs and Diagnostics: CBC and chem unremarkable. CRP 2.2. X-ray of femur (+) for soft tissue swelling.	PVT	PUB		No	No. PMH:  none			1						1	Injection site reaction	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B103AC~UNK~UN~UN~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~500576P~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB258AA~UNK~UN~UN~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1120Y~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1284X~UNK~UN~UN~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0335574	12/18/2008	NJ	51.0	51		F	11/17/2008	Facial redness and pruritis.									Y	11/06/2008	11/06/2008	0	Allergic, CIPRO	PUB	PUB	AVANDIA, BID		NIDDM (non insulin dependent diabetes mellitus)			1						1	Erythema; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89126~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0335577	12/18/2008	HI	15.0	15		F	12/10/2008	Client closed eyes, looked like she was going to faint and then she had two jerky movements. She then opened her eyes and asked what happened. Jerky movements lasted three seconds. Involved head and upper body.									Y	12/10/2008	12/10/2008	0		PUB	PUB		Mild cold symptoms, cough, runny nose			HI0809	1						1	Dyskinesia	FLU3~SANOFI PASTEUR~U2806AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHA4B246AA~1~IM~RA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~1208F~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2538AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B020AA~2~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0335613	12/18/2008	MI	4.0	4		F	12/18/2008	LARGE AREA OF REDNESS AND SWELLING ON HER LEFT THIGH WITHIN 12 TO 24 HOURS AFTER IMMUNIZATIONS				Y					Y	12/11/2008	12/12/2008	1		PVT	PUB	N/A	N/A	N/A	N/A~ ()~NULL~~In Patient		1						1	Injection site erythema; Injection site swelling	DTAP~SANOFI PASTEUR~C2957AA~5~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2805AA~5~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0492~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1089X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1279X~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0335614	12/18/2008	NY	38.0	38		M	12/18/2008	Right ELBOW AND POSTERIOR FOREARM - RASH -MACULAR PAPULAR wAISTLINE- ITCHY only no rash									Y	12/01/2008	12/04/2008	3	none	PVT	PVT	none	none	none			1						1	Pruritus; Rash maculo-papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89297- 2p~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0335615	12/18/2008	PR	62.0	62		M	12/18/2008	11/18/08 Headache;11/19/08 Rhinitis, Malaise, Dizziness, Edema in eyes.  Note: This symtoms continues until 12/10/08.   12/10/08 2:00 a.m. convulsions and patient was hospitalized with R/O TIA vs CNS infection. Note: Patient still at Hospital.			Y	Y	Y				U	11/18/2008	12/10/2008	22	12/10/08 CSF: WBC-0, RBC-0, Protein-31, Glucose-67  Directigen-Neg, Gramstain- no org., Results of Herpes Simplex and Fungus are pending.	UNK	UNK	Tenormin, Cozaar	none	allergic to iodine, chron's disease, coronary artery disease (CAD), CABG x 1, deep venous trombo (DVT)	Influenza like symptoms~Influenza (Seasonal) (no brand name)~UN~32.00~Patient		1						1	Blood glucose; CSF glucose normal; CSF protein normal; CSF white blood cell count negative; Convulsion; Dizziness; Eyelid oedema; Gram stain negative; Headache; Herpes simplex; Malaise; Protein total increased; Red blood cell count normal; Rhinitis	FLUX~SANOFI PASTEUR~u-2828aa~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0335618	12/18/2008	WY	51.0	51		M	12/18/2008	Became sick with flu like symptoms the day of shot, went home from work sick.  A couple of weeks after shot, began to have tingling sensation in bottom of both feet.  Slowly progressed to numbness in legs, feet, ankles.  Has no feeling in legs but can still walk.  Saw first MD on 11/20/08 and again on 11/26/08 then referred to neurologist. After numerous tests Dr diagnosed client with ADEM (Acute Disseminated Encephalomyelitis). Symptoms have not improved. No treatment at this time.   3/20/08 Received Neuro consult medical records of 12/16-12/29/2008. FINAL DX: ADEM w/peripheral & central demyelination Records reveal patient experienced insidious onset plantar numbness bilaterally which ascended up legs x 4 wks.  Had experienced GI prodrome after foreign travel approx 2 wks prior to onset of symptoms.  Neuro exam revealed bilateral LE dysesthesias, distal sensory loss, DTRs brisk on L.				Y					N	10/24/2008	11/07/2008	14	Multiple blood tests, ENG, Spinal tap, MRI.  3/18/09 Received hospital medical records which consisted only of visual evoked potentials WNL, somatosensory evoked potentials of UEs WNL, somatosensory evoked potentials of LEs abnormal & c/w cord demyelination vs cerebral abnormality. EMG/NCS abnormal.  CSF WNL.  MRI brain & spine abnormal.  Leiden factor V mutation(heterozygote),	UNK	UNK	Zocor	None	High Cholesterol  PMH: genital herpes, dyslipidemia, trauma, lumbar disc protrusion L5.  Family hx: early dementia, homozygous Leiden factor V mutant, blood clots.  ex-smoker.  Giardia siguera, food poisoning.			1						1	Activities of daily living impaired; Acute disseminated encephalomyelitis; Hypoaesthesia; Influenza like illness; Lumbar puncture; Paraesthesia	FLU3~SANOFI PASTEUR~U2808AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335620	12/18/2008	NH	73.0	73		M	12/18/2008	complains  of itching all  over his body he has  caused bruises on his arms He got flu shot three days ago.Hesays the  itching strted soon after receiving the shot.				Y					Y	10/15/2008	10/18/2008	3	none	PUB	PUB	albuterol,alendronate,amlodipine,B12 oral, gabapentin,hydrochlorothiazide,lorazepam,losartan,omeprazole,oxycodone/APAP,simvastatin,tiotropium	none	hyperlipidemia,hypertension,COPD,osteoporosis,obesity			1						1	Contusion; Pruritus generalised	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLA184AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0335622	12/18/2008	KS	73.0	73		M	12/18/2008	Pt initally presented to hospital on 10/20-10/26/08 with gait instability, garbled speech and Left sided weakness.  Pt was re-admitted to hospital on 11/20-11/23/08 with worsening weakness, increasingly garbled speech and severe gait instability.  Pt. transferred to hospital on 11/23/08 for a brain biopsy.  Brain Biopsy revealed demyelination consistent with progresive multifocal Leukoencephalopathy.  Pt's neurological status deteriorated until pt expired on 12/11/08.  11/22/2008 MR received for multiple admissions beginning ~10/20/2008.  Pt expired 12/11/08 with COD Progressive Multifocal Leukoencephalopathy. Pt presented to local hospital 10/20-26/08 with respiratory distress and admitted for COPD exacerbation and CHF. Also having sx of L sided weakness attributed to possible TIA. Pt d/c but developed increasing L-sided weakness and hemineglect and readmitted 11/10/08 with D/C DX: Immunogenic encephalitis s/p vaccination, Diabetes with hyperglycemia on steroids, COPD. Pt was acting confused with abnormal behavior c/w encephalitis. Started on antiviral and steroids w/o improvement. Pt continued to progress with worsening psychomotor retardation. Pt transferred to rehab for several days and admitted agian 11/19/08 for brain biopsy. D/C DX: Infiltrative bilateral frontal lobe process, extending into the brain stem, possible postvaccinal encephalomyelitis.  COPD, Dyslipidemia.  Basilar artery stenosis, HTN, DM, DVT risk, morbid obesity. Brain bx (+) for JC virus which lead to dx of PML. Pt with decreasing LOC.  Transferred to hospice care. Pt expired 12/11/2008. 2/5/09 Death Cert received.  COD:  Progressive Multifocal Leukoencephalopathy.	Y	12/11/2008		Y	Y	34	Y	Y	N	10/16/2008	10/18/2008	2	11/10/08 MRI:  Acute Inflamatory process in both frontal lobes crossing the Corpus Callosum, consistent with encephalitis.  On 11/24/08, open brain biopsy showed demyelination consistent with progressive multifocal leukoencephalopathy.  On 12/08/08, testing showed the presence of JC Virus.  Labs and Diagnostics:  MRI brain (+) for possible subacute R frontal stroke, later determined to be acute inflammatory process. Repeat showed progression. MRA (+) for severe focal stenosis. LP showed no sign of infection. Myelin basic protein elevated. Neuron specific enolase (+). EEG (+) for background slowing.  PCR and viral tests for HSV, CMV, HZV, West Nile, enterovirus, EBV, Lyme all (-).  CXR (+) for atelectasis and possible pleural effusion.  Brain bx (+) for JC virus.	UNK	UNK	Albuterol-2 puffs QID, Flovent-1 puff QD, Avapro 150mg PO QD, Calcium Carbonate 1 tablet PO QD, Lasix 40mg PO QD, Asprin 81mg PO QD, Fish Oil 1000mg PO QD, Plavix 75mg PO QD, Prandin 2mg PO QD, Zocor 40mg PO QD.	None	COPD- well controlled, Diabetes Type 2, wel controlled. PMH: DM, Dyslipidemia, COPD, HTN, ? CHF, Allergies to sulfa, PCN, doxycycline, yellow dye #2.			1						1	Biopsy brain abnormal; Death; Demyelination; Gait disturbance; Hemiparesis; JC virus infection; Laboratory test abnormal; Nuclear magnetic resonance imaging brain abnormal; Progressive multifocal leukoencephalopathy; Speech disorder	FLU3~SANOFI PASTEUR~2761AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0335626	12/18/2008	IL	4.0	4		M	12/18/2008	Erythema and warmth 2-3cm distal to site of injection noticed 1 day after injection. Area of erythema and warmth spread around arm by day#2. No systemic signs/symptoms. Site is painful to touch.  Site is indurated and warm but not fluctuant.									U	12/16/2008	12/17/2008	1	None	MIL	MIL	None	No	None			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~ut2941aa~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335627	12/18/2008	OK	49.0	48		M	12/18/2008	Ct. states that he had nosebleed for one month following administration of intranasal influenza vaccine.									Y	11/22/2005	11/23/2005	1		PUB	PUB		Sinus infection self reported.				1						1	Epistaxis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~500390P~1~IN~NS~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0335629	12/18/2008	CA	54.0	54		M	12/18/2008	Two days after a flu-shot on Oct. 2nd, I got headache, fever, sneezing and terribly fatigue, later on coughing which lasted for almost 10 days. The same symptomes repeated 3 times. The last one was just immiediately after the Thanksgiving and it lasted longer than the previous two with coughing and sputum till early this week (Dec 15th, 2008). I was happy to went through this terrible sickness. Unfortunately, I got headeche sneezing, fatigue and chilly again since this morning. These symptoms make me feel that the 4th cycle comes back to me again. I used to be a very heathy and seldomly sick person. This was the first time in my life that the terrible sickness made me lay in bed for so long repeatedly since I got the vaccine.									N	10/02/2008	10/04/2008	2		UNK	UNK	None	All of the Flu-like symptoms	None			1						1	Activities of daily living impaired; Cough; Fatigue; Feeling cold; Headache; Productive cough; Pyrexia; Sneezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8811003~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0335630	12/18/2008	TX	39.0	39		M	12/18/2008	ADMINISTERED INJECTION ON 11/15/08.  PT CALLED ON 11/30 SAYING BOTH HE & HIS WIFE HAVE EXPERIENCED SEVERE PAIN/SORENESS IN RIGHT UPPER ARM. HE FEARS THAT THE SHOT WAS GIVEN IN WRONG PLACE (HIGH-TOP OF SHOULDER)& THAT THE PAIN CONTINUES TO WORSEN. PT STATED THAT IBUPROFEN & SPORTS CREAM ARE NOT HELPING. ON 12/1/08, I RETURNED HIS CALL & TOLD HIM TO SEE A DOCTOR. ON 12/2, PT TOLD ME HE HAD SEEN HIS DOCTOR & WAS GIVEN AN ORAL CORTICOSTEROID FOR 1 WEEK. DOCTOR SPECULATED THAT THE JOINT OR BURSA SACK MAY HAVE BEEN HIT.  (HIS WIFE DID NOT SEE A DOCTOR. HE STATED THAT SHE CANNOT TAKE A CORTICOSTEROID BECAUSE OF A CURRENT HEALTH CONDITION). ON 12/17, PATIENT SAYS HE HAD COMPLETED THE CORTICOSTEROID. PAIN SUBSIDED WHILE ON MED,BUT NOW HAS RETURNED. HIS WIFE IS SOMEWHAT BETTER.  THE DOCTOR HAS TOLD PATIENT THAT HE SHOULD HAVE AN MRI.  PATIENT SAYS HE WILL DO THIS AFTER THE HOLIDAYS ARE OVER.									U	11/15/2008			UNKNOWN	UNK	UNK	UNKNOWN	NONE	UNKNOWN			1						1	Arthropathy; Bursa disorder; Pain; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88363~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0335644	12/18/2008	FL	61.0			M	12/18/2008	Pt reported 6 wks ago flu shot received. Guillian-Barre syndrome developed. 12/12-weakness developed. Admitted 12/13/08 to hosp for weakness, dysphasia, dizzy, disoriented.  12/31/08 Reviewed hospital medical records of 12/13-12/18/2008. FINAL DX: no d/c summary available.  Neuro consult states likely GBS. Records reveal patient experienced flu like syndrom approx 1 week after the flu shot.  Lives out of country & was visiting.  Nine days prior to admission fell while rollerblading & injured shoulder tx w/NSAIDS.  Three days prior to admission developed weakness of LEs & paresthesias of hands.  Weakness progressed to UEs, difficulty swallowing, difficulty walking, speech impairment.  Admitted to ICU Neuro consult done.  Areflexic on exam.  LP done.  Tx w/IVIG, improved & d/c to home.					Y	5			Y		12/10/2008		Complete metabolic panel; CBC; LP; Mono test; Myco test; MRI spine; MRI Brain; CT Brain  LABS: CBC & chemistry WNL.  CT brain WNL.  MRI brain & spine c/w mild spinal stenosis & small benign meningioma.  CSF: protein 40(N), glucose 56(N), c/s neg. ECG abnormal w/sinus bradycardia & intraventricular conduction delay.	OTH	OTH		Not known	No known allergies; post medical hx-negative  PMH: asthma, hay fever, knee surgery.			1						1	Disorientation; Dizziness; Dysphasia; Guillain-Barre syndrome; Lumbar puncture; Mononucleosis heterophile test; Scan brain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0335645	12/18/2008	NC	60.0	60		M	12/17/2008	Lightheaded, dizzy, palpitations, patient went to ER and was given fluids.				Y					Y	12/04/2008	12/05/2008	1		PVT	PVT						1						1	Dizziness; Palpitations	FLU3~SANOFI PASTEUR~U2798DA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1076X~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0335648	12/18/2008	VA	1.0	1	.0	M	12/18/2008	Hives urticaria -seen in ER - given BENADRYL, EPIPEN Jr, PRELONE, and ZANTAC.				Y					Y	12/16/2008	12/16/2008	0	None	MIL	MIL	Had recently completed course of amox prescribed 12/7	Recovering from ear infection	Currently being eval. for ? seizure D.O.			1						1	Urticaria	FLU3~SANOFI PASTEUR~UT27925A~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB279AA~1~IM~LL~HEP A (HAVRIX)~1|HIBV~SANOFI PASTEUR~UF575AC~3~IM~LL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~08C8U~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~D06803~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1192X~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0335651	12/18/2008	NY	64.0	64		F	12/18/2008	Throbbing in deltoid area on and off.  Heaviness and pain from left deltoid region extending to left palm intermittent since getting FLUZONE.  Once above where injection was asymptomatic.				Y					N	12/05/2008	12/13/2008	8		PVT	PVT	Non-contributory	None	None	Cold symptoms~Influenza (Seasonal) (Fluzone)~1~63.00~In Patient		1						1	Injection site pain; Pain; Sensation of heaviness	FLU3~SANOFI PASTEUR~U2755AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335653	12/18/2008	KY	38.0	38		F	12/18/2008	Pt. diagnosed with bursitis due to flu vaccine. Going into joint spur and not muscle. Required multiple MD visits and physical therapy due to illness.				Y					U	11/21/2008	12/15/2008	24		OTH	PVT		No: Pt. stated well				1						1	Bursitis; Vaccination complication	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0335654	12/18/2008	WV	27.0	27		F	12/08/2008	App 4 hours after immunization, the pt. reportedly developed blisters on her lips, and her lips and face were swollen.  Pt. refused to seek medical care.  Symptoms completely resolved within 24 hrs, without treatment.									Y	10/14/2008	10/14/2008	0	None	PUB	PUB	Unknown	None	Allergic to Sulfa; PCN; AMPICILLEN		WV0840	1						1	Lip blister; Lip swelling; Swelling face	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA172AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0335655	12/18/2008	WV	84.0	84		M	12/08/2008	Red, raised rash under arms and on buttock. Appeared approximately 1 pm on 11-18-08, almost 24 hours after Rash itching resolved within 12 hours after taking baking soda bath.									Y	11/17/2008	11/18/2008	1	None	PUB	PVT	Unknown	None			WV0841	1						1	Pruritus; Rash erythematous; Rash papular	FLU3~CSL LIMITED~01949111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0335658	12/18/2008	CA	1.3	1	.3	F	12/18/2008	Vaccine received 11/21/08. Pt presented 12/3/08 with inability to bear weight on (L) leg - no trauma, no recent illness, no fever, (-) X-ray, on 12/8 had wrist pain post MMR Arthralgia.				Y					N	11/21/2008	12/03/2008	12	X-ray (-)	PVT	PVT	None	None	None			1						1	Arthralgia; Weight bearing difficulty; X-ray normal	FLU3~SANOFI PASTEUR~UT2785CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1291X~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1192X~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0337527	12/18/2008	IN	1.8			U	11/12/2008	A non-serious spontaneous report of administration to 20-month-old was received from a registered pharmacist. Medical history and concomitant medications were not reported. On 08-Nov-2008, a 20-month-old child (gender not reported) received FluMist, There was no adverse event associated with third medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.									Y	11/08/2008	11/08/2008	0		OTH	OTH	Concomitant Drug(s); Not Reported				MEDI0007509	1						1	Inappropriate schedule of drug administration; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337528	12/18/2008	CT	4.0	4		M	11/13/2008	A non-serious spontaneous report of back is covered with a rash has been received from a consumer in the USA concerning a 4-year-old male subsequent to FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  The patient has no known allergies.  Medical history and concomitant medications were not reported.  On 12-NOV-2008, at 12:00 noon, the patient received FLUMIST at a military naval base.  On 13-NOV-2008, the patient woke up with a rash from his neck to his waist both front and back itched. The rash was described as little red bumps. He had no other symptom and no problem breathing. The patient experienced the same reaction when he was one year old from the varicella vaccine. The patient was seen by a physician in a navy clinic but was not treated with anything. The following day, the rash was better and fully resolved by 15-Nov-2008. Additional information received on 05-Dec-2008 was incorporated into the narrative and included date of birth additional details about the event and outcome.  The patient had no problems breathing.  The outcome of the event was not reported. This is in follow-up to report(s) previously submitted on 11/13/2008. The patient has no known allergies but did experience the same reaction when he was one-year-old from the Varicella vaccine. The patient was not taking any concomitant medications. Additional information received on 07-Jan-2009 from a nurse in the immunization clinic included the lot number and expiration date at the FLUMIST and confirmation that the patient was seen in the clinic and was not treated.									Y	11/12/2008	11/13/2008	1		MIL	MIL	Concomitant Drug (s) Not Reported		Patient experienced the same reaction when he was one-year-old from the Varicella vaccine. Past disease: Rash	Rash~Varicella (no brand name)~UN~1.00~Patient	MEDI0007508	1						1	Rash; Rash erythematous; Rash pruritic	FLUN3~MEDIMMUNE VACCINES, INC.~500552P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337529	12/18/2008	OH	1.6	1	.6	M	11/21/2008	A non-serious spontaneous report of FLUMIST administered to a 20-month-old was received from a registered nurse in the USA.  The reporter confirmed that there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  The case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  Additional information was obtained on 21-Nov-2008 and incorporated into the narrative: patient demographics, FLUMIST administration date and route of administration, event outcome and other authorities informed.									Y	11/10/2008	11/10/2008	0		PUB	OTH	Concomitant Drug (s) Not Reported		NI		MEDI0007507	1						1	Inappropriate schedule of drug administration; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337530	12/18/2008	GA	1.5			F	11/12/2008	A non-serious, spontaneous report of FLUMIST given by mistake to an 18 month-old infant girl was received from a consumer.  There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.									Y	11/11/2008	11/11/2008	0		PVT	OTH	Concomitant Drug (s) Not Reported		NI		MEDI0007506	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~50553P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337531	12/18/2008	TX	4.0			M	11/10/2008	A non-serious spontaneous report of vomiting has been received from a consumer concerning a four-year-old male subsequent to FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  Medical history and concomitant medications were not provided.  On 10-Nov-2008, the patient received FLUMIST.  Forty minutes after receiving FLUMIST, the patient threw up/experienced vomiting.  The outcome of the event was not reported.									U	11/10/2008	11/10/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007470	1						1	Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337532	12/18/2008	MN	3.0			F	11/06/2008	A non-serious spontaneous report of FLUMIST got in her eye was received from a registered nurse concerning a three-year-old female. Medical history and concomitant medications were not reported. On 06-Nov-2008, during administration of FLUMIST, the patient moved and experienced exposure of the vaccine into her eyes. The reporter inquired about what to expect from this exposure. The reporter states that the medication error occurred at another clinic and no additional information is available, however, the nurse did submit a VARES report for this case. There was no adverse event associated with this medication error; therefore, treatment and reporter / sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007466	1						1	Accidental exposure	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337533	12/18/2008	CO	3.0			M	11/07/2008	A non-serious, spontaneous report of eye blinking was received from a nurse, concerning a three year-old male subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 04-Nov-2008. Twenty four hours after administration the patient's eye started blinking and has not stopped. The outcome for the event was not resolved.									U	11/04/2008	11/05/2008	1		PVT	OTH	Concomitant Drug (s) Not Reported				MEDI0007465	1						1	Excessive eye blinking	FLUN3~MEDIMMUNE VACCINES, INC.~500577P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337534	12/18/2008	NE	1.9			M	11/07/2008	A non-serious spontaneous report of administration to a 23-month-old was received from a nurse.  The patient received FLUMIST on 06-Nov-2008.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007463	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~IN500560P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337535	12/18/2008	NC	2.0	2	.7	F	11/25/2008	A non-serious unlabeled spontaneous report of mycoplasma pneumonia and accompanying symptoms has been received from a nurse concerning a 33 month-old female; 33 days after the infant received FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  The only medical history reported was a language delay, the patient is on no concomitant medications.  The patient received FLUMIST nasally on 25-Sep-2008 for flu vaccination.  On 23-Oct-2008 the experienced a fever up to 101 degrees Fahrenheit.  On 28-Oct-2008 the patient was seen by her pediatrician, she had cough and stuffy nose with nasal discharge.  Her pediatrician diagnosed probable mycoplasma pneumonia, no lab testing or chest x-ray was done.  The physician also noted crackles in the infant's chest.  She was treated with ZITHROMAX for 5 days.  According to the infant's mother the infant is doing better.  The event of mycoplasma pneumonia and the accompanying symptoms are resolving as of 06-Nov-2008.										09/25/2008	10/23/2008	28		OTH	OTH	Concomitant Drug (s) Not Reported		language delay		MEDI0007458	1						1	Cough; Crepitations; Nasal congestion; Pneumonia mycoplasmal; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337537	12/18/2008	RI	2.0			M	11/03/2008	A non-serious, spontaneous report of FLUMIST given to a child taking aspirin, in a two year-old male patient was received from a consumer. There was no adverse event associated with this medication error as of seventeen days after administration; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.									Y	10/17/2008	10/17/2008	0		OTH	OTH	ASPIRIN		Unknown date: Pulmonic valve surgery		MEDI0007434	1						1	Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337538	12/18/2008	PA	4.0	4		M	11/03/2008	A non serious labeled spontaneous report of fever and cold symptoms has been received from a registered nurse concerning a four-year-old male, three days after receiving FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. According to the reporter the patient has no past medical history; no concomitant medications were provided. The patient received FLUMIST on 01-Oct-2008. On 04-Oct-2008 the patient experienced a fever of 103 degrees Fahrenheit and cold symptoms. No treatment information was provided. The fever resolved on 05-Oct-2008 and the cold symptoms resolved one week later on 11-Oct-2008. The patient's physician indicated they did not believe the event was related to FLUMIST.									Y	10/01/2008	10/04/2008	3		PVT	PVT	Concomitant Drug (s) Not Reported				MEDI0007433	1						1	Nasopharyngitis; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~50055P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337539	12/18/2008		4.0			F	11/03/2008	A non-serious, spontaneous report of acute asthma exacerbation, chest tightness and cough was received from a military nurse concerning a four year-old female, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's past medical history includes asthma. No concomitant medications have been reported for this patient. The patient received FLUMIST on 22-Oct-2008. On 26-Oct-2008 the child experienced coughing and acute exacerbation attack of asthma and was taken to the emergency room. The child was seen at the clinic on 27-Oct-2008 and 31-Oct-2008 for continuing symptoms of coughing and chest tightness. As of 03-Nov-2008 the child was stable with no symptoms.									Y	10/22/2008	10/26/2008	4		MIL	OTH	Concomitant Drug (s) Not Reported	Asthma			MEDI0007367	1						1	Asthma; Chest discomfort; Cough	FLUN3~MEDIMMUNE VACCINES, INC.~500555P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337540	12/18/2008	IL	4.0			F	11/02/2008	A non-serious, spontaneous report of swollen lymph nodes was received from a nurse concerning a four year-old female subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST during the week of 27-Oct-2008 through 31-Oct-2008. On 02-Nov-2008 the child's left side of face, neck and behind the ear was swollen. The area is not sore to touch. The patient was being taken for treatment at a local health care provider. The outcome for the reported adverse event was not reported.									U	10/01/2008	11/02/2008	32		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007364	1						1	Auricular swelling; Local swelling; Lymphadenopathy; Swelling face	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337554	12/18/2008	TX	3.0	3		F	11/25/2008	A spontaneous non-serious report of administration of half dose has been received from a medical assistant in a doctor's office concerning a 36-month-old female subsequent to FLUMIST. Medical history and concomitant medications were not reported. There was no adverse event associated with this event; therefore, treatment and reporter/sponsorcausality assessments are not applicable, and the event is considered resolved. This case is admitted in accordance with edImmune's post-marketing commitment on accelarated reporting for the newly indicated population of 2 years to 55 months of age for FLUMIST.									Y	11/19/2008	11/19/2008	0		PVT	OTH	Concomitant Drug (S) Not Reported				MEDI0007574	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~IN500584P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337555	12/18/2008	MN	4.0			F	11/26/2008	A non-serious report of vomited twice has been received from a nurse concerning a four-year-old female. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history nor concomitant medications were provided. The patient received FLUMIST for the first time on 25-Nov-2008. One hour after the dose of FLUMIST, the patient experienced two episodes of vomiting. Per the child's parents, there were no other problems and the patient was doing well. The events resolved on 26-Nov-2008.									Y	11/25/2008	11/25/2008	0		PVT	OTH	Concomitant Drug (s) Not Reported				MEDI0007570	1						1	Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337556	12/18/2008	OR				F	11/29/2008	A non-serious spontaneous report of expired FLUMIST administered was received from a pharmacist concerning a female child. No medical history was provided for the child. The patient was inadvertently given FLUMIST that had expired four days prior. There was no adverse event associated with this medication error: therefore treatment and causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of two years to 59 months of age for FLUMIST.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/29/2008	11/29/2008	0		PVT	PVT	Concomitant Drugs (s) Not Reported				MEDI0007568	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337557	12/18/2008	MD	3.0			U	11/26/2008	A non-serious report of administered expired FLUMIST has been received from a nurse concerning a 36-month-old of unknown gender. No medical history nor concomitant medications were provided. On 26-Nov-2008, the country health department inadvertently administered expired FLUMIST to ten patients. The product was expired by one day. The patient did not experience any adverse events and will be re vaccinated in four weeks. There  was no adverse event associated with this medication error; therefore, treatment and reporter / sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. This is in follow-up to report(s) previously submitted on 11/26/2008. Based on the results of the investigation, this root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 04-Apr-2009: product complaint investigation results.									Y	11/26/2008	11/26/2008	0		PUB	PVT	Concomitant Drug (s) Not Reported				MEDI0007563	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500543P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337558	12/18/2008	VT	4.0			F	11/26/2008	A non-serious spontaneous report of fever, vomiting, chills sore throat, and runny nose has been received from a nurse concerning a four- year old female subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither past medical history nor concomitant medications were reported. The patient received FLUMIST on 25-Nov-2008. The patient woke up on 26-Nov-2008 with a fever, vomiting, chills, sore throat, and runny nose. The outcome was not reported. The events of fever, vomiting, chills, sore throat, and runny nose resolved on approximately 03-Dec-2008, within one week after the onset of the events. Additional information received 08-Jan-2009 and incorporated into the case outcome and resolution date.									Y	11/25/2008	11/26/2008	1		PUB	PUB	Concomitant Drug (s) Not Reported				MEDI0007561	1						1	Chills; Oropharyngeal pain; Pyrexia; Rhinorrhoea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~IN500561P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337559	12/18/2008	MN	4.0	4		F	11/26/2008	A non-serious labeled spontaneous report of vomiting has been received from a registered nurse concerning a 4-year-old female, subsequent to receiving FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 year to 59 month of age for FLUMIST.  No medical history or concomitant medication information was provided.  The patient received her first dose of FLUMIST on 25-Nov-2008.  On 25-Nov-2008, one hour after receiving FLUMIST the patient experienced two vomiting episodes, each episode was one hour apart.   No other problems were reported.  The vomiting resolved and the patient was doing fine the day after the event.									Y	11/25/2008	11/25/2008	0		PVT	OTH	Concomitant Drug (s) Not Reported				MEDI0007560	1						1	Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500557P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337560	12/18/2008	NM	3.0	3		F	11/25/2008	Incorrect route of drug administration (Incorrect route of drug administration) A non-serious report of FLUMIST sprayed in eyes has been received from a consumer concerning a 38-month-old female.  During administration of FLUMIST on 25-Nov-2008, the patient was accidentally sprayed in the eyes.  Her eyes were washed with warm water.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.									Y	11/25/2008	11/25/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007556	1						1	Accidental exposure	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337562	12/18/2008	TX				U	11/19/2008	A serious spontaneous report of important medical event BELL's Palsy with facial symptoms has been received from a physician, concerning a child of unspecified age and gender subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of  2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on an unspecified date. A physician reported a child experienced BELL's Palsy with facial symptoms after FLUMIST. The symptoms resolved on an unspecified date.									Y					PVT	OTH	Concomitant drug (s) not reported				MEDI0007534	1						1	Facial palsy	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337563	12/18/2008	OK	0.7			F	11/18/2008	Incorrect dose administered (Incorrect dose administered) A non-serious, spontaneous report was received from a nurse involving the administration of one-half dose of FLUMIST to an eight month-old female patient.  There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.									Y	11/18/2008	11/18/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007530	1						1	Inappropriate schedule of drug administration; Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337564	12/18/2008	WA				M	11/13/2008	A non-serious spontaneous report of nose bleed has been received from a medical assistant concerning a child, male patient subsequent to FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  No medical or drug history was reported for this patient.  The patient received FLUMIST at a pediatric clinic on 13-Nov-2008.  The patient experienced nose bleed while still in the office.  The outcome of the adverse event was not reported.									U	11/13/2008	11/13/2008	0		PVT	OTH	Concomitant Drug (s) Not Reported				MEDI0007521	1						1	Epistaxis	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337565	12/18/2008	KS	2.0	2	.0	F	11/13/2008	A non-serious spontaneous report of FLUMIST was sprayed into the patient's eye was received from a Registered Nurse concerning a 24-month-old female.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for Medical history and concomitant medications were not reported.  On 12-Nov-2008, the patient received FLUMIST.  The patient jumped while FLUMIST was being administered and the vaccine was sprayed into one eye.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. On 05-Dec-2008, the reporting nurse confirmed that there were no late - occuring advere events repoted.									Y	11/12/2008	11/12/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007516	1						1	Accidental exposure	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337566	12/18/2008	SC	1.5	1	.6	F	11/13/2008	A non-serious spontaneous report of FLUMIST administered to an 18-month-old and wheezing has been received from a pharmacist, subsequent to FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  Neither past medical history nor concomitant medication were reported.  The patient received FLUMIST intranasally on 30-Oct-2008.  The 18-month-old patient was given FLUMIST inadvertently. The patient returned to the clinic on 15-Nov-2008 and the the mother reported wheezing.  The patient has an appointment to be evaluated by a health care professional.  The outcome for the events is unknown.									U	10/30/2008	10/30/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007514	1						1	Inappropriate schedule of drug administration; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0329466	12/19/2008	CO	30.0	30		M	10/29/2008	Lightheaded, dizzy, nausea, vomiting 3x, feeling weak. Report received from EMT on 20-Oct-2008. A 30 year-old male patient (F.W.D., DOB 31-Jan-1978) received AFLURIA lot 03549111A on 20-Oct-2008 at 10:00am at his work facility. AFLURIA was administered at the left deltoid. Patient began feeling lightheaded, dizzy and nauseous 30 minutes after administration. He then vomited three times over the next 30 minutes. Patient denied ever having headache, chest pain, difficulty breathing, abdominal pain, dizzy and nauseous. He then left work for the day and was contacted at home 2 hours later and at that time he was still feeling weak and dizzy. At the time of vaccination, patient had no illnesses; however, patient was uneasy as he does not like receiving needles. Patient has no pre-existing physician-diagnosed allergies, birth defects, or medical conditions. The reporter considered events as non-serious. No further information is expected.									Y	10/20/2008	10/20/2008	0	N/A	OTH	OTH	NONE	NONE/asymptomatic	NONE		200814194	1						2	Asthenia; Dizziness; Nausea; Vomiting; Activities of daily living impaired; Asthenia; Dizziness; Nausea; Vomiting	FLU3~CSL LIMITED~03549111A~1~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|FLU3~CSL LIMITED~0354911A~1~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~2	USA		Influenza
0329877	12/19/2008	OH	29.0	29		F	10/29/2008	Report received from a nurse on 22-Oct-2008.  A 29 year-old female received AFLURIA (lot 03549111A, IM right deltoid) for influenza immunization on 20-Oct-2008 at approximately 14:00 hours.  The patient had a medical history of BACTRIM allergy.  She is on no other medications.  Patient had no illness at time of vaccination.  On 20-Oct-2008 at approximately 18:00 hours (four hours post vaccination with AFLURIA), the patient developed serve itching in her mouth and over her entire body.  There were no visible rash, hives, or skin disorders noted.  The patient returned to work on 21-Oct-2008 and informed the medical staff.  The patient was offered referral to emergency room but she refused treatment.  Investigation by the nurse revealed no rash, hives and skin disorders.  The nurse educated the patient regarding signs/symptoms of anaphylactic shock, and she instructed the patient to go to the ER if the symptoms persist or worsen.  The nurse indicates the patient has not yet recovered.  Additional information has been requested.  No serious criteria mentioned.  Follow-up information was received on 28-Oct-2008 from the Physician.  The patient's reaction has subsided (no date provided).  She is not pregnant and has not contacted her primary care physician (PCP) about this reaction.  No additional information is expected.  No change in assessment.  Information derived from this AE report does not change the current safety profile of the product.									Y	10/20/2008	10/20/2008	0		OTH	OTH	None	None	BACTRIM allergy		200814212	1						2	Oral pruritus; Pruritus generalised; Oral pruritus; Pruritus generalised	FLU3~CSL LIMITED~03549111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|FLU3~CSL LIMITED~03549111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~2	USA		Influenza
0330310	12/19/2008	IL	35.0	35		F	10/29/2008	Report received from a medical staff associate on 24-Oct-20008.  A 35-year-old female received AFLURIA (CSL influenza vaccine) by IM injection to the right deltoid (lot number 03549111A, exp date 30-Jul-2009) on 23-Oct-2008 at 6:00 pm.  At 8:30 pm on 23-Oct-2008, the patient had shortness of breath and suffered abdominal muscle contractions.  The patient stated that this incident was similar to previous allergic reactions, leading her to believe that the reaction was an allergic reaction.  Reactions resolved after self-administering BENADRYL PO.  The patient was not ill at the time of vaccination.  The patient has a medical history of allergic reactions; allergy to sulfa and to cough syrup with codeine.  No additional information is expected. No serious criteria mentioned.  Causality: Possible.  Follow-up report received via telephone from the consumer on 27-Oct-2008.  Patient confirms she is not pregnant and she recovered within 24 hours of the vaccination.  No change is assessment.  No further information is expected.  Information derived from this AE report does not change the current safety profile of the product.									Y	10/23/2008	10/23/2008	0		OTH	PVT	None	None	Allergy to sulfa, cough syrup with CODEINE		200814220	1						2	Dyspnoea; Muscle contracture; Abdominal rigidity; Dyspnoea; Similar reaction on previous exposure to drug	FLU3~CSL LIMITED~03549111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|FLU3~CSL LIMITED~03549111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~2	USA		Influenza
0330993	12/19/2008	OH	45.0	45		F	11/24/2008	Report received from a Registered Nurse (RN) on 29-Oct-2008.  A female patient (E.W./ age not yet known) received AFLURIA (CSL Influenza vaccine, lot 02649111A) on 27-Oct-2008.  The patient developed bruising at the site (less than a pencil head), soreness of deltoid muscles, pain down forearm, across neck and down back, patchy rash on upper arm (pinker than flesh tone), and flushing on upper back.  The injection site was also sore and swollen.  Patient will be following-up with either her family physician or a personal medical center.  Additional information has been requested.  Assessment: No serious criteria mentioned.  Causality:  Possible.  Follow-up information received on 31-Oct-2008 from RN.  A 45 year-old female received AFLURIA IM on the left deltoid on 27-Oct-2008 at 12:00 pm with no problem.  At the time of vaccination, patient was not ill.  Patient has a history of cervical cellular dysphasia.  Patient does has a history of allergy to seafood (oysters and crabs) which caused a rash and itchiness to her palm and soles of feet.  Sore arm started on 28-Oct-2008.  On 29-Oct-2008 at 7:30am, her reaction was more painful; patient's left upper arm was swollen, reddened with a patchy non-raised rash.  It was painful down her left forearm and her left side of neck was stiff.  Patient also had a headache.  On 30-Oct-2008, she had general malaise, chills, and fatigue; her left deltoid and trapeziums were sore, and she had a headache.  As of 31-Oct-2008, patient still had neck and trapeziums muscular stiffness/pain and her headache persisted.  For treatment, patient took prednisone dose pack and BENADRYL.  Her physician diagnosed her with a localized allergic reaction.  Concomitant medication includes ZOLOFT 200 mg daily and PEPCID 20 mg daily.  Patient is not pregnant.  Mfr./imm. Proj. report no. 200814240.  No further information is expected.  No change in assessment.  Information derived from this AE report does not affect the current safety profile of AFLURIA (Fluvax).				Y					U	10/27/2008	10/29/2008	2		OTH	OTH	ROLOFT; PEPCID	None	Allergy to oysters and crab legs; Cervical cellular dysplasia		200814240	1						2	Chills; Erythema; Fatigue; Headache; Hypersensitivity; Malaise; Musculoskeletal stiffness; Oedema peripheral; Pain in extremity; Rash; Back pain; Chills; Erythema; Fatigue; Flushing; Headache; Hypersensitivity; Injection site haematoma; Injection site pain; Injection site swelling; Malaise; Musculoskeletal stiffness; Myalgia; Neck pain; Pain in extremity; Rash	FLU3~CSL LIMITED~02649111A~3~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|FLU3~CSL LIMITED~02649111A~3~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~2	USA	Emergency room visit	Influenza
0331073	12/19/2008	IL	25.0	25		F	12/02/2008	Allergic reaction, chest tightness, difficulty breathing, pale, diaphoretic, pulse 118. Report received on 27-Oct-2008. A 25 year-old female patient(AEH, DOB 20-Mar-1983) received AFLURLA (Influenza vaccine, lot 03549111A) by IM injection in right deltoid for immunization on 24-Oct-2008 at 10:40 Am. The patient had no illness at the time of vaccination and had no pre-existing medical conditions. On 24-Oct-2008 at 11:15 Am after AFLURLA was injected, patient developed chest tightness, had difficulty breathing, became pale, and experienced diaphoresis and rapid pulse(118). Investigation by representative at emergency room (ER) treated patient for allergic reaction (ICD 995.3, allergy unspecified) and the patient returned to work on 27-Oct-@008. The reporter indicates the patient recovered									Y	10/24/2008	10/24/2008	0	NI	OTH	PVT	NI	NONE	NONE		200814235	1						2	Chest discomfort; Dyspnoea; Heart rate; Hyperhidrosis; Pallor; Chest discomfort; Dyspnoea; Heart rate increased; Hyperhidrosis; Hypersensitivity; Pallor	FLU3~CSL LIMITED~03549111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|FLU3~CSL LIMITED~03549111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~2	USA		Influenza
0335736	12/19/2008	FL	1.01	1	.0	M	12/12/2008	Child was seen in our office 2 days after shots given - continued to run high fever and (L) thigh area red and painful - would not bear weight. 1/27/09-records received for DOS 12/11-12/14/08-DC DX:Cellulitis versus reaction to DTaP in left thigh. Presented with C/O pain, redness and swelling left thigh and temperature 104. Unable to contact hasn't been seen since.				Y	Y	3			U	12/09/2008	12/09/2008	0	WBC 26.92 thousand 1/27/09-records received- Elevated white blood count. 27,000.	PVT	OTH		None	None			1						1	Injection site erythema; Injection site pain; Pyrexia; Weight bearing difficulty; White blood cell count increased	DTAP~SANOFI PASTEUR~U2070BA~3~UN~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2752AA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0006V~3~UN~LL~HEP B (FOREIGN)~1|HIBV~SANOFI PASTEUR~UF105AB~3~UN~LL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~942440~3~UN~RL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~102162~2~UN~RL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0335739	12/19/2008	PA	1.3	1	.3	M	12/11/2008	Pt. had 2 febrile seizures on 12/10/08, 1 day after receiving vaccines.				Y					U	12/09/2008	12/10/2008	1	Spinal tap/CT scan	PVT	PUB		None	Asthma; Gastroesophageal reflux			1						1	Computerised tomogram; Febrile convulsion; Lumbar puncture	FLU3~SANOFI PASTEUR~U2764AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1119X~1~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0997X~1~UN~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0335741	12/19/2008	NE	66.0	66		F	12/02/2008	Shingles shot (right arm) when I awoke the next morning, the arm was extremely sore.  Unable to move it (including combing hair, brushing teeth).  It was worse when I walked, as I could feel the skin on my arm move with each step.  This  lasted only 1 day.  Took TYLENOL for pain.  Mild ache the evening of vaccination.									Y	11/06/2008	11/07/2008	1	None	PVT	OTH	ALENDRONATE 20mg;  HYDROCLOROTHIAZINE 12.5mg;  Calcium;  Multivitamin, Aspirin, CHOLINE 250;  ENABLEX 2.5 mg	None	None	sore lymphnodes~Influenza (Seasonal) (no brand name)~1~55.00~In Patient		1						1	Injected limb mobility decreased; Pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2755AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~18206~UNK~UN~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0335744	12/19/2008	WI	10.0	10		M	12/09/2008	Based on lot # recording- appears that DTap was administered instead of Hep A.  Unable to confirm if DTap was actually given instead of Hep. A.  Recommended re start Hep A series.  Mother stated there were no adverse side effects following vaccines, told  to wait minimum 6 mos after any Td/Tdap dose.										10/31/2008				PUB	PUB						1						1	Wrong drug administered	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B064AA~UNK~IM~UN~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2828AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1221X~UNK~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0335745	12/19/2008	CA	1.5	1	.5	F	12/10/2008	Urticaria. Developed clear rhinorrhea cold symptoms 1 day after immunizations.									Y	12/08/2008	12/09/2008	1	None	PVT	PVT	None	None	None			1						1	Nasopharyngitis; Rhinorrhoea; Urticaria	DTAP~SANOFI PASTEUR~C3000AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2782CA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB260AA~1~IM~RL~HEP A (HAVRIX)~1	USA		Influenza
0335747	12/19/2008	PA	18.0	18		M	12/17/2008	Dizziness approx 5pm.  Stumbling & trouble walking approx 5:30pm- felt eyes rolling back, eyes were fluttering for approx 5min, extreme malaise, fell asleep- next am felt  fine									Y	12/15/2008	12/15/2008	0		OTH	OTH	Finished a course of CIPRO Sunday evening	None	NKA			1						1	Dizziness; Gait disturbance; Gaze palsy; Malaise; Convulsion; Dizziness; Gait disturbance; Gaze palsy; Malaise	FLU3~SANOFI PASTEUR~U2853AB~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2853A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0335750	12/19/2008	TX	39.0	39		F	12/04/2008	On October 8, 2008 my family (husband, 2 sons, and myself) met at the middle school where our sons attend school, to receive our yearly flu shots. This is where the Department of Health was set up. The Flu shot that was given was administered very high in my left arm, in shoulder area. This shot hurt more than any other shot that I have received. I told the nurse that gave me the shot that it hurt extremely bad. She told me that the new syringes that they use now require them to put a little pressure on them to make the needle retract. After I was given the shot my arm started getting sore. In the next few weeks the pain increased, hurting when I tried to lift my arm, when I was laying down and rolled over on my left shoulder or when I was dressing or undressing. On October 21, 2008 I went to se my family doctor. He examined me and told me that the shot had either punctured the bursa sack in my left shoulder or had come extremely close to it, causing there to be some inflammation in that area. He prescribed me an anti- inflammatory medication, but that did not help the pain. On October 30, 2008 I went back to Dr, he then prescribed PREDNISONE. After taking this medication for 10 days, there was still no relief from the pain. On November 12, 2008 I went to see Dr, an orthopedic doctor. After his exam, he agreed with family Dr. diagnosis that the bursa area was inflamed due to shot. He gave me cortisone shot in my left shoulder to target the affected area, but still did not relieve pain. On December 2, 2008 I went back to Dr for 3 week follow- up. Since the cortisone shot did not help, Dr ordered an MRI. He said , depending on the results from the MRI, he may recommend physical therapy. On December 4, 2008 I went for MRI and currently have an appointment with Dr on December 9, 2008 to get results.									U	10/08/2008	10/08/2008	0		OTH	PVT	PAXIL; Aspirin; Fish oil; LUNESTA (as needed)	None				1						1	Inflammation; Injection site pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2739AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335751	12/19/2008	WA	49.0	49		M	12/01/2008	The evening of the flu shot, noticed raised lesions that resemble hives, vesicle fluid filled, itched-broke out on arms, chest- injection site- no lesions noted- no fever noted - lesion scarred in two days.									Y	11/14/2008	11/14/2008	0	None	PVT	OTH	Allergy med- CLARITEN	None	Seasonal allergy	nerve damage~Influenza (Seasonal) (no brand name)~0~48.00~In Sibling		1						1	Injection site rash; Rash papular; Rash pruritic; Scar	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~87684~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0335752	12/19/2008	WA	38.0	38		F	12/03/2008	4 days after FLUVIRIN vaccine notice bump ? chickenpox on lower leg (2), trunk (cluster of 3), and arm, very itchy, no temperature - lesion went away in a day.									Y	11/14/2008	11/18/2008	4	None	OTH	UNK	ZYRTEC;YAZ	None	hay fever; pollen; dust.			1						1	Pruritus; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8788202~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0335754	12/19/2008	WA	53.0	53		F	12/04/2008	11/7/08 day of vaccine - note routine soreness and bruising at injection site. 11/13/08c/o left arm pain at injection site. 11/19/08 check arm no swelling,  no induration, no bruising - pain at site. 12-2-08 went to doctor on ER for arm pain - R/O pinch nerve vs muscle infection.				Y					U	11/07/2008	11/13/2008	6	None known	UNK	OTH	CADUET; ALEVE; KEFLEX; ELAVIL	None	Increase Blood pressure; ? Thyroid; seasonal			1						1	Injection site haematoma; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89684~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0335758	12/19/2008	OH	37.0	37		F	12/19/2008	Had a fever of 103.5, disorientation, paleness, weakness, tachycardia of 120-130's, hoarseness and dizziness.									Y	12/17/2008	12/17/2008	0		PUB	UNK	Zyrtec, Benicar	None	MMR vaccine			1						1	Asthenia; Disorientation; Dizziness; Dysphonia; Pallor; Pyrexia; Tachycardia	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0335764	12/19/2008	GA	18.0	18		M	12/19/2008	Patient vaccinated with Menactra on 6/25/07 (lot U2236AA).  Culture confirmed meningococcal disease on 9/26/07.  Blood culture was positive for Neisseria meningitidis serogroup C. 1/6/09-records received-on 9/26/08-Three day history of fatigue, fever, tachycardia, altered mental status, blurry vision and headache. Developed diffuse rash, renal failure, coagulopathy and repiratory failure. 1/6/09-autopsy report received-Neisseria Sepsis. Antemortem blood culture positive for neisseria meningitidis, serogroup C. Bilateral hemorrhagic adrenal necrosis (Waterhouse-Friderichsen syndrome). Diffuse confluent petechial purpuric rash. petechial hemorrhages of left conjunctivia, gingivae, scalp and subgaleal tissue. Small vessel fibrin thromboemboli identified clinically disseminated intravascular coagulopathy (DIC). Neutrophilic pulmonary airspace infiltration consistent with terminal ventilator dependence. Bilateral pleural effusions.	Y	09/27/2007			Y	1			N	06/25/2007	09/26/2007	93	Blood culture positive for Neisseria meningitis serogroup C on 9/26/07.	UNK	UNK						1						1	Blood culture positive; Death; Meningitis meningococcal; Serology abnormal	FLU3~AVENTIS PASTEUR~Unk~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~SMITHKLINE BEECHAM~AHAVB139CA~UNK~UN~UN~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~Y1D302~UNK~UN~UN~POLIO VIRUS, INACT. (IPOL)~1|MNQ~SANOFI PASTEUR~U2236AA~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TD~SANOFI PASTEUR~U1962AA~UNK~UN~UN~TD ADSORBED (NO BRAND NAME)~1	USA	Results in Death	Influenza
0335765	12/19/2008	CA	30.0	30		F	12/19/2008	Patient received flu shot at 7:58PM. Asked patient to stay in the store for 20 minutes after the shot. Patient returned to the clinic at 8:20PM complaining of mild itching over her extremities and back. No rash/hives/redness is visible on the extremities or trunk on examination. Patient denies dizziness or SOB. Patient stated that it's an weird sensation. Patient given Children's Liquid Benadryl, 12.5mg/5mL, 10mL given by mouth in the clinic and monitored for nearly 40 minutes. Patient tolerated medication fine and symptoms not worsened. Instructed patient to continue to take Children's Liquid Benadryl, 12.5mg/5mL, 10mL by mouth every 4-6 hours for the next 24 hours. Patient instructed to call 911 immediately if symptoms of urticaria, angioedema, respiratory symptoms, dizziness or changes in level of consciousness occurs. Patient verbalized understanding of instructions.									U	12/16/2008	12/16/2008	0	None	UNK	UNK	None	None	None			1						1	Pruritus	FLU3~SANOFI PASTEUR~U2768AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335771	12/19/2008	MN	45.0	45		F	12/19/2008	Shot was given at about 12:40 pm on 12/8/2008. During the evening at about 5:00 pm I felt fatigue, dizziness, weak knees and a very sore arm at the injection area. When I woke up on the morning of 12/10/2008 I experienced tingling in my left hand. Over the weekend the tingling turned to pain in the left hand and arm. I saw Dr. on Monday, December 15th for diagnosis. He referred me to the clinic where I was tested at 9:45 AM on 12/19/2008. I believe when the shot was given my Ulnar nerve was nicked and that is what is causing the tingling and pain in my hand.				Y					N	12/08/2008	12/10/2008	2	Dr. examinined the hand tapped on several areas, performed reflex tests and gave me a brace to stabilize the hand and wrist. He referred me to the clinic where NCV and EMG diagnostic tests were preformed.	UNK	UNK	None	None	Allergies to animals and codeine			1						1	Asthenia; Dizziness; Electromyogram; Fatigue; Injection site pain; Nerve conduction studies; Pain in extremity; Paraesthesia; Electromyogram; Nerve conduction studies; Unevaluable event	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U2743AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0335774	12/19/2008	NV	25.0	25		M	12/19/2008	CHILLS,NAUSEA, TINGLING IN LEFT ARM, FATIGUE									Y	11/17/2008	11/18/2008	1		MIL	MIL	NONE	FEVER, CHILLS	NKA			1						1	Chills; Fatigue; Nausea; Paraesthesia	FLU3~SANOFI PASTEUR~U2941AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335775	12/19/2008	TX	18.0	18		F	12/19/2008	Subject 1-07-03285 is a nearly 19 year old G2P1 female who was initially seen in the emergency room on 05Feb2008 for 1 day history of sporadic vaginal bleeding with no other symptoms. Her last menstrual period was 20Dec2007. Her human chorionic gonadotropin (HCG) level was 18,638 units/ml, which is consistent with 4 to 5 weeks gestation. An ultrasound revealed an intrauterine pregnancy. Urine analysis was negative for trichomonas by wet mount but positive by PCR. Her urine analysis was also negative for yeast and positive for clue cells and moderate amount of WBC. She was diagnoses with a threatened miscarriage and was sent home for follow-up in one week. Her specimen from the cervix was reported positive on 07Feb2008 for Chlamydia trachomatis by PCR and was negative for Neisseria gonorrhoeae. Subject was again seen in the ER on 11Feb2008 for daily vaginal bleeding of approximately 1 pad/day. She complained of mild suprapubic cramping. Repeat ultrasound showed an irregular yolk sac contour and a fetal pole that was not visualized. Mean gestational sac measurement corresponded to a 7 week gestation. Her HCG increased to 20,000 units/ml. These observations were consistent with nonviable pregnancy and impending miscarriage. She was sent home and instructed to take prenatal vitamins and avoid cigarette smoke. Repeat cervical test for GC and Chlamydia was again positive for Chlamydia trachomatis by PCR. The subject was seen in the ER on 03Mar2008 for vaginal discharge irritation and for treatment of her positive Chlamydia trachomatis test. Her HCG level was 8 consisted with a nonpregnant state. An ultrasound did not reveal an intrauterine pregnancy. Subject was treated with rocephin 250 mg IM and one gram oral dose of zithromax.   Final diagnosis: Complete Miscarriage Secondary: Chlamydia trachomatis cervicitis  Past Medical History: none Medication: none.  Date of Last Menstrual Period: 20 Dec 2007   Influenza vaccine: FluMist Date of Vaccination: 21 Nov 2007 Date of Birth: 13 Feb 1989 Date of SAE:  March 3, 2008 SAE: Serious and unexpected. SAE not related to FluMist.				Y					Y	11/21/2007	03/03/2008	103	intravaginal ultrasound and HCG test	UNK	UNK	None	None	None			1						1	Abortion spontaneous; Cervicitis; Chlamydial infection; Drug exposure during pregnancy; Muscle spasms; Polymerase chain reaction; Pregnancy test; Ultrasound scan vagina; Urine analysis abnormal; Vaginal discharge; Vaginal haemorrhage	FLUN3~MEDIMMUNE VACCINES, INC.~500491P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0335776	12/19/2008	CA	20.0	20		F	12/19/2008	DYSPNEA, RHINORRHEA, WHEEZES APPROX 30-40 MINS AFTER MULTIPLE INJECTIONS.  TREATED SUCCESSFULLY WITH ALBUTERAL/IPRATROPIUM, PREDNISONE, O2 AND BENADRYL.   SHE THEN DEVELOPED A RASH BUT NEVER HAD ANY RASH OR ERYTHEMA AT INJECTION SITES.  SHE WAS DISCHARGED WITH FLOVENT, RANITIDINE,ZYRTEC,ALBUTERAL MDI RXS.				Y					Y	12/05/2008	12/05/2008	0	O2 SAT 94%  INITIALLY AND INCREASED TO 99% WITH TREATMENT	UNK	PUB	NONE	NONE	NONE-PT LATER STATED SHE HAD A HX OF ENVIRONMENTAL ALLERGIES AND USED TO TAKE HYPOSENSITIZATION INJECTIONS AND USED ZYRTEC PRN			1						1	Dyspnoea; Oxygen saturation decreased; Rash; Rhinorrhoea; Wheezing	FLU3~SANOFI PASTEUR~U2745AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB252AA~1~IM~LA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~A0805-2~UNK~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|YF~SANOFI PASTEUR~UF426AA~1~SC~RA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0335778	12/19/2008	DC	28.0	28		M	12/19/2008	RECEIVED INFLUENZA IM VACCINE VIA THE INTRANASAL ROUTE										11/20/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0335779	12/19/2008	DC	23.0	23		M	12/19/2008	RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE									Y	11/20/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0335780	12/19/2008	CA	22.0	22		F	12/19/2008	Guillain Barre Syndrome Resolved s/p IVIG x 5 day; symtoms occured after recent Flu Vaccination at work place.  1/08/09 Reviewed hospital medical records of 12/08-12/17/2008. FINAL DX: Guillain-barre syndrome Records reveal patient experienced bilateral LE weakness, numbness & ascending paralysis; blurry vision; & difficulty swallowing x 2 days.  ICU Neuro & ENT consults done.  Tx w/IVIG & improved dramatically.  D/C to home w/continued outpatient PT/OT.					Y	10			Y	11/24/2008	12/04/2008	10	MRI WNL; SPINAL TAP WNL; EMG CONSISTENT with Guillain Barre(manufacturer of the vaccination is unknown to us)  LABS: WBC 13.1(H). Chemistry WNL.  CSF WNL.  EMG/NCS c/w GBS.  MRI/MRA head WNL. CT head & spine WNL.  Swallow study.	UNK	UNK	None	None	NKDA Prior to Influenza Vaccination			1						1	Blood product transfusion; Electromyogram abnormal; Guillain-Barre syndrome; Lumbar puncture; Nuclear magnetic resonance imaging normal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88634~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0335781	12/19/2008	DC	32.0	32		M	12/19/2008	RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE									Y	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0335782	12/19/2008	DC	33.0	33		F	12/19/2008	RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE									U	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0335783	12/19/2008	DC	48.0	48		M	12/19/2008	RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE									Y	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0335784	12/19/2008	DC	54.0	54		M	12/19/2008	RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE									Y	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0335786	12/19/2008	DC	39.0	39		M	12/19/2008	RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE									Y	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0335787	12/19/2008	DC	42.0	42		M	12/19/2008	RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE									Y	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0335788	12/19/2008	DC	31.0	31		M	12/19/2008	RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE									Y	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0335789	12/19/2008	DC	26.0	26		M	12/19/2008	RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE									Y	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0335795	12/19/2008	OH	12.0	12		F	12/12/2008	A serious, spontaneous report of conversion disorder reaction, facial muscles have not moved and numbness in toes and fingers was received from a consumer concerning a 12 year old female subsequent to FLUMIST. The patient has a history of psychosocial issues. The patient received GARDASIL the same day as FLUMIST. The patient received FLUMIST intranasal for Flu vaccination on 11-Nov-2008. On 11-Nov-2008 the patient was seen in the pediatricians office for chest pains and during the visit received FLUMIST and GARDASIL. Since 24 hours after administration the patients facial muscles have not moved and she has numbness in her toes and fingers. The patient subsequently was seen by a neurologist, cardiologist and the pediatrician for the events and an MRI was taken. Results are not available. The events are on going and the patient is scheduled to begin physical therapy. The responsible physician assessed the events as not related to vaccine administration and instead considered the event a conversion disorder reaction. The event is considered a serious important medical event.  1/2/09 Received PCP, ER & Neuro medical records of 11/24-12/3/08 FINAL DX: none provided; possible conversion reaction Records reveal patient experienced HA, weakness, difficulty walking, pain in all extremities x approx 3 wks.  Missed several days of school.  Had been seen in Urgent care 11/24 & 11/27 for sore throat, HA & body aches.  W/u WNL.  Dx w/viral illness & pharyngitis.  Flat affect, weight loss.  Required follow-up attempts have been performed, requested information unable to be obtained.				Y						11/11/2008	11/12/2008	1	LABS: CBC, CRP, CK, CMP all WNL.	PVT	OTH	Concomitant Drug(s) Not Reported		Psychosocial issues in school  PMH: eczema, constipation, head trauma 1 yr ago, fall, umbilical hernia repair.  Family hx: SLE & mental health issues.		MEDI0007625	1						1	Arthralgia; Chest pain; Conversion disorder; Facial paresis; Gait disturbance; Hypoaesthesia; Physiotherapy	FLUN3~MEDIMMUNE VACCINES, INC.~500553P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0523U~3~UN~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0335797	12/19/2008	NY	1.3	1	.3	F	12/19/2008	Fever started 2 days after receiving vaccination, bleeding a lot. Rash 3 days after receiving the vaccine's , started on her face now spreading to her body. Cough, runny nose for 1 day. pink macular papular rash on face, rash also at trunk. Slight nasal discharge.									U	12/12/2008	12/14/2008	2	Rubella, IgG; CBC; Rubella, Ab,IgG; Rubella, IgM, in progress	PUB	PUB	None	None	Mild Asthma			1						1	Blood immunoglobulin G; Blood immunoglobulin M; Cough; Full blood count; Haemorrhage; Measles antibody; Pyrexia; Rash; Rash maculo-papular; Rhinorrhoea; Rubella antibody negative	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B054AA~4~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2797A~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0413U~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C87310~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1285X~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0335800	12/19/2008	IN	5.0	5		M	12/18/2008	Redness and swelling started on 12/2.  Patient brought in on 12/3/08, 2.5X5cm area of erythema on left thigh, without tenderness or warmth.  Continued to spread overnight and was started on KEFLEX on 12/4/08 for ollulitis.				Y					U	12/01/2008	12/02/2008	1		PUB	PUB	None	None	None			1						1	Injection site cellulitis; Injection site erythema; Injection site swelling	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B084BB~5~UN~LL~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~42828AA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1081X~2~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1192X~2~UN~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0335802	12/19/2008	MI	65.0	65		F	12/19/2008	3cm induration, erythematous. Mildly  tender, afebrile. 3 days after administration of vaccine. went to ER 12/12/2008 given PREDNISONE and AATARAX.				Y					Y	12/11/2008	12/12/2008	1		PVT	UNK	GLUCOSAMINE; CRESTOR; ECCHANACHIA		LIPITOR (muscle aches)			1						1	Erythema; Induration; Tenderness	FLU3~SANOFI PASTEUR~U27411AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0978X~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0335811	12/19/2008	MI	29.0	29		M	12/19/2008	Received vaccine at 6:30 pm on 12-17-08. Severe vomiting began at 2:30am with fever. Vomiting continued til 9am.									U	12/17/2008	12/18/2008	1		OTH	UNK						1						1	Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2754AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337887	12/19/2008	CA	49.0	49		F	11/12/2008	Report received from a Pharmacy Buyer on 31-Oct-2008.  A patient (age/sex/initials not reported) received AFLURIA (CSL Influenza vaccine) on an unknown date.  On an unknown date, patient experienced vertigo.  Per the Pharmacy Buyer, she does not know any more details.  Pharmacy Buyer to have the Pharmacist call CSL Biotherapies and provide additional information.  Pharmacy Buyer would not provide name nor phone number of pharmacist.  No serious criteria mentioned.  Causality: unassessable/unclassifiable.  Follow-up information received on 03-Nov-2008 from a pharmacist.  A 49 year-old female received AFLURIA (CSL Influenza vaccine; lot 02349111A, exp date 30-Jun-2009) on 24-Oct-2008.  On 28-Oct-2008, she was experiencing vertigo.  Patient's physician does not believe the vertigo was caused by the AFLURIA, physician believes the patient's viral syndrome which she had two weeks prior to the flu shot was the cause.  Patient had not yet recovered.  Assessment:  The company considered this event unlikely to be related to the suspect drug.  Informaiton derived from this AE report does not change the current safety profile of AFLURIA (CSL Influenza vaccine).									U	10/24/2008	10/28/2008	4		OTH	OTH			Viral Syndrome		200814267	1						1	Vertigo	FLU3~CSL LIMITED~02349111A~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0337889	12/19/2008	WA	26.0	26		F	10/29/2008	Report received from ZLB Plasma Center 0n 27-Oct-2008.   A 26 year-old female (S.L. / DOB 08-AUG-1982) received AFLURIA (CSL influenza vaccine, lot 03549111A) on 22-Oct-2008 at 13:27.  On 20-Oct-2008, patient was given two doses IM of HEPATITIS vaccine, lot 0398x.   At the time of her AFLURIA vaccination, patient had no illness.  Patient had no pre-existing allergies, concomitant medications or medical conditions.  On 23-Oct-2008 at 9:30am, approximately 20 hours after receiving AFLURIA, patient complained of nausea, malaise, and muscle pain.  Per the reporter, the patient recovered.  Additional information had been requested.  Assessment:  No serious criteria mentioned.  Causality: Possible.  Follow-up information was received on 28-Oct-2008 from ZLB Plasma Center on 28-Oct-2008.  The patient's symptoms resolved in about 48 hours.  She did not contact her primary care physician (PCP) and was not treated for her symptoms.  Patient is not pregnant.  No additional information is expected.  No change is assessment.  Information derived from this AE report does not change the current safety profile of the product.									Y	10/22/2008	10/23/2008	1		OTH	OTH	None	None	None		200814234	1						1	Malaise; Myalgia; Nausea	FLU3~CSL LIMITED~03549111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0337890	12/19/2008	KY	19.0	19		F	12/02/2008	Report received from a PharmD on 27-Oct-2008.  PharmD reported that a patient (initials, DOB and gender unspecified), over 18 years-old, experienced shingles/chicken pox after receiving AFLURIA (CSL Influenza vaccine, date of administration unknown).  It is not yet known how long after receiving AFLURIA that the patient experienced shingles/chicken pox.  The reporter is not sure if the patient had any other disease states of medications.  Additional information has been requested.  Assessment: No serious criteria mentioned.  Causality: unclassifiable/ unassessable.  Follow-up information received on 18-Nov-2008 from PharmD.  A 19 year-old female received AFLURIA by IM injection to the upper deltoid on the evening of 17-Oct-2008 (lot 02349111A).  At the time of vaccination, patient had no illness nor was patient receiving any other medications.  On 24-Oct-2008, the patient 'came down' with the chicken pox which was medically confirmed on 25-Oct-2008 by her physician.  Patient recovered (date not provided).  Follow-up information received on 19-Nov-2008 from PharmD.  Patient is not pregnant.  No additional information is expected.  The company considered this event as unlikely to be related to the administration of AFLURIA.  Information derived from this AE report does not change the current safety profile of AFLURIA (FLUVAX).				Y					Y	10/17/2008	10/24/2008	7		OTH	OTH		None			200814233	1						1	Herpes zoster; Varicella	FLU3~CSL LIMITED~02349111A~UNK~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0337891	12/19/2008	KY	26.0	26		M	11/12/2008	Report received from a PharmD on 27-Oct-2008.  PharmD reported that a patient (initials, DOB and gender unspecified), over 18-years-old, experienced shingles/chicken pox after receiving AFLURIA (CSL influenza vaccine, data of administration unknown).  It is not yet known how long after receiving AFLURIA that the patient experienced shingles/chicken pox.  The reporter is not sure if the patient had any other disease states or medications.  Additional information has been requested.  ASSESSMENT:  No serious criteria mentioned.  Causality:  unclassifiable/unassessable;  Follow-up information received on 07-Nov-2008 from PharmD.  A 26 year-old male patient (G.S.L./DOB 16-Jul-1982), received AFLURIA (CSL Influenza vaccine) on the upper deltoid IM on 01-Oct-2008 at 7:30 pm.  Lot 02349111A was administered.  At the time of vaccine, patient had no illness.  No pre-existing conditions or allergies nor concomitant medications were noted.  On 15-Oct-2008, patient started to get itchy around lower extremities and had severe pain in trunk.  Patient saw his physician who diagnosed symptoms as shingles (no mention of chicken pox as noted earlier).  Physician stated treatment would be in vain after shingles breakout.  Patient is recovering.  No further information is expected.  The company considered events as unlikely to be related to the administration of AFLURIA.  Information derived from this AE report dies not change the current safety profile of AFLURIA (FLUVAX).				Y					Y	10/01/2008	10/15/2008	14		OTH	OTH	None	None	None		200814232	1						1	Herpes zoster; Pain; Pruritus; Varicella	FLU3~CSL LIMITED~02349111A~1~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0337892	12/19/2008	MN				U	11/17/2008	Report received from a PharmD on 27-Oct-2008.  An employee received AFLURIA (CSL influenza vaccine, data of administration unknown).  At unknown time after administration, the patient developed localized reactions at the injection site 2-4 inches in diameter.  The site was red and circular, warm, and puffy.  The employee received a prefilled syringe.  (The report concerned two patients.  For other patient, see case 200814226).  Additional information has been requested.  ASSESSMENT:  No serious criteria mentioned.  Causality: unassessable/unclassifiable.  Follow-up information was received on 11-Nov-2008 from the PharmD.  Per the PharmD, he will not be providing any additional details as he discussed the case with the hospital nurse and they decided the events were within the expected and listed ADRs.  No change in assessment.  Information derived from this AE report dies not change the current safety profile of AFLURIA (FLUVAX).									U					OTH	OTH					200814227	1						1	Injection site erythema; Injection site reaction; Injection site swelling; Injection site warmth	FLU3~CSL LIMITED~~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0337893	12/19/2008	MN				U	11/17/2008	Report received from a PharmD on 27-Oct-2008.  An employee received AFLUIA (CSL influenza vaccine, date of administration unknown).  At unknown time after administration, the patient developed localized reaction at the injection site 2-4 inches in diameter.  The site was red and circular, warm, and puffy.  The employee received a prefilled syringe.  (The report concerned two patients.  For other patient, see case 200814227).  Additional information has been requested.  No serious criteria mentioned.  Causality: unassessable/ unclassifiable.  Follow-up information was received on 11-Nov-2008 from the PharmD.  Per the PharmD, he will not be providing any additional details as he discussed the case with the hospital nurse and they decided the events were within the expected and listed ADRs.   No change in assessment.  Information derived from this AE report does not change the current safety profile of AFLURIA (FLUVAX).									U					OTH	OTH					200814226	1						1	Injection site erythema; Injection site reaction; Injection site swelling; Injection site warmth	FLU3~CSL LIMITED~~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0337895	12/19/2008	IN	21.0	21		F	12/02/2008	Report received from a Plasma Center employee on 23-Oct-2008.  A 21 year-old female received AFLURIA (CSL Influenza vaccine) via IM injection to the right deltoid (lot 03549111A) on 20-Oct-2008 at 20:30 hours.  The patient had no pre-existing diagnosed allergies or medical conditions.  She was not ill at the time of vaccination. On 20-Oct-2008 at 21:00 hours, patient had general/localized pain in the area of right deltoid.  The pain spread from shoulder to elbow.  Patient stated that her fingers started tingling at approximately 1:00am on 21-Oct-2008.  When she awoke at 6:00am on 21-Oct-2008, her arm was numb.  There was no redness, swelling, or bruising noted to the area.  Temperature was 98.4 F.  Patient had not been running a fever, but the patient felt like she did have a fever the morning post the injection (21-Oct-2008).  Additional information has been requested.  No serious criteria mentioned.  The company considered these events as possibly related to the administration of AFLURIA.  Follow-up information received from a nurse on 06-Nov-2008 from Plasma Center.  Per the reporter, patient has recovered and did receive treatment at the regional occupation care center where she was given (?) PREDNISONE.  No further information is expected.  Information derived from this AE report does not change the current safety profile of the AFLURIA (CSL Influenza vaccine).  Results of CSL Quality Assurance batch review for 03549111A received 18-NOV-2008.  All deviations related to the manufacture of this lot were assessed as having no impact on product quality.  All QC testing was satisfactory with no out of specification results reported.  There are no outstanding issues for this lot that would potentially affect product quality.  In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported.									Y	10/20/2008	10/20/2008	0		OTH	OTH		None	None		200814218	1						1	Feeling hot; Hypoaesthesia; Musculoskeletal pain; Pain in extremity; Paraesthesia	FLU3~CSL LIMITED~03549111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0337896	12/19/2008	CA	54.0	54		F	10/29/2008	Report received from RN who is also the patient on 23-Oct-2008.  An adult female (BLH) received AFLURIA on 22-Oct-2008 (the patient was unsure if dose was from pre-filled syringe or vial).  The patient experienced chest tightness, swelling or throat, and ears clogging 2 hours post-vaccination.  She took 25 mg BENADRYL and felt better 30 minutes later.  She went to the ER and received a SOLU-MEDROL shot and received prescription for PREDNISONE 20 mg twice daily for 5 days.  The patient reported she feels much better today (23-Oct-2008) and her symptoms are basically gone.  Patient reports history of allergy to penicillin and THIMERISOL.  Awaiting further information.  No serious criteria mentioned.  Causality: Possible.  Follow-up information received on 24-Oct-2008 from an RN (not the patient who is also a RN).  RN confirmed that this 54 year-old female received a single dose syringe of AFLURIA IM to the left arm on 22-Oct-2008 at 8:00am.  Lot administered: 01149111A.  At 11:00am on 22-Oct-2008, patient experienced chest discomfort and her voice became hoarse.  She has no prior allergic reactions to flu shots or allergies to the preservatives for the vaccine.  She was evaluated and treated in the emergency department.  Her EKG was normal (date/time not provided).  Patient took 25 mg PO BENADRYL for 5 days, SOLUMEDROL IM, and PREDNISONE PO.  Per the RN, patient has fully recovered.  It is not known if patient received any other vaccinations within 4 weeks prior to receiving AFLURIA.  No further information is expected.  No change in assessment.  Information derived from this AE report does not change the current safety profile of the product.									Y	10/22/2008	10/22/2008	0		OTH	OTH			Allergy to penicillin; Allergy to THIMERISOL		200814217	1						1	Chest discomfort; Dysphonia; Ear discomfort; Electrocardiogram normal; Pharyngeal oedema	FLU3~CSL LIMITED~01149111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0337897	12/19/2008	WA	58.0	58		F	11/12/2008	Report received from Plasma Center employee on 23-Oct-2008:  A 58 year-old female received AFLURIA (CSL Influenza vaccine) IM at left deltoid on 20-Oct-2008 at 9:53 AM (0953).  AFLURIA lot # administered 03549111A, exp date 30-JUN-2009.  The patient had no illnesses at the time of vaccination.  Concomitant medications reported as hydrocodone prn and OTC allergy medication prn.  Reporter indicates the patient has experienced adverse events following prior vaccinations: at age 20 (??-???-1970) with cholera vaccination and at age 31 (??-???-1981) with swine flu vaccination.  On 21-Oct-2008, at 10:00 AM, approximately 24 hours post-vaccination, the patient complained of nausea, muscle pain, malaise and vomited once.  The reporter indicates the patient was recovered at the time of the report (23-Oct-2008).  The reporter considered the event as non-serious.  No further information is expected.  No serious criteria mentioned.  Causality:  Possible.  Follow-up information received on 28-Oct-2008 from Plasma Center Employee.  The patient did not contact her primary care physician, she is not pregnant, and she recovered fully.  No further information is expected.  Information derived from this report does not change the current safety profile of the product.									Y	10/20/2008	10/21/2008	1		OTH	OTH	HYDROCODONE; OTC allergy medication- prn	None	Allergic reaction to prior vaccinations: cholera and swine flu	X~Cholera (no brand name)~UN~20.00~In Patient|X~Influenza (Seasonal) (no brand name)~UN~31.00~In Sibling	200814216	1						1	Malaise; Myalgia; Nausea; Vomiting	FLU3~CSL LIMITED~03549111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0337898	12/19/2008	CO				F	12/02/2008	Report received from an Emergency Medical Technician (EMT) at Plasma center on 22-Oct-2008:  A female employee received AFLURIA (CSL influenza vaccine) on 21-Oct-2008 at 10:00 AM.  AFLURIA lot # 03549111A, exp date 30-Jun-2009.  The patient developed headache, nausea, chills, muscle aches, and fever 100.2F starting 2 hours after receiving the shot (12:45 PM).  Awaiting further information.  No serious criteria mentioned.  Causality: Possible.  Information derived from the AE report does not change the current safety profile of the product.  Results of CSL Quality Assurance batch review for 03549111A received 18-NOV-2008.  All deviations related to the manufacture of this lot were assessed as having no impact on product quality.  All QC testing was satisfactory with no out of specification results reported.  There are no outstanding issues for this lot that would potentially affect product quality.  In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event report.									U	10/21/2008	10/21/2008	0		OTH	OTH					200814215	1						1	Chills; Headache; Myalgia; Nausea; Pyrexia	FLU3~CSL LIMITED~03549111A~UNK~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0337900	12/19/2008	IN	19.0	19		F	11/24/2008	Report received from Plasma Center on 21-Oct-2008.  An employee received AFLURIA on 21-oct-2008 and has developed numbness in her arm and her fingers are tingling.  Additional information has been requested.  No serious criteria mentioned.  Causality:  Conditional/ Unclassified.  Follow-up information received on 22-Oct-2008 from Plasma Center.  A 19 year-old non-pregnant female received AFLURIA, lot 03549111A, on 21-Oct-2008 14:15.  Vaccine administered IM to right deltoid.  Immediately following vaccination, the patient experienced pain.  At 18:30, the patient complained of tingling and numbness in fingers that spread to entire arm.  Reactions occurred on the same arm as the vaccination.  Patient was warm to the touch and red; temperature was 99.1 F.  She continued feeling warm and became sweaty.  She was instructed to go to the emergency room for evaluation and treatment.  As of 22-Oct-2008, the tingling/numbness has resolved but the pain continues.  At the time of the vaccination, patient was not ill.  Patient does have seasonal allergies.  Additional information has been requested.  No change in assessment.  The company considered events to be probably related to the suspect drug.  Follow-up information received on 22-Oct-2008 from Plasma Center.  Per reporter, the tingling and pain (hurting) continues.  The patient has not contacted her physician about this reaction.  Follow-up information received on 05-Nov-2008 from Plasma Center.  Per the reporter, the symptoms resolved within a couple of days.  Patient did seek medical attention; details are not known by reporter.  Follow-up information received on 06-Nov-2008 from a nurse at Plasma Center.  Per the reporter, patient has recovered and did receive treatment (unspecified) at the hospital, and she was told to take IBUPROFEN.  Hospital told patient that it (reaction) was just the muscle pushing against the nerve.  Follow-up information received on 07-Nov-2008 from a medical staff associate at the Plasma Center.  Along with the tingling in her fingers, patient also had discomfort.  No further information is expected.  Information derived from this AE report does not change the current safety profile of AFLURIA (CSL influenza vaccine).  Results of batch review for 0354911A received on 18-NOV-2008:  All deviations related to the manufacture of this lot were assessed as having no impact on product.  All deviations related to the manufacture of this lot were assessed as having no impact on product quality.  All QC testing was satisfactory with no out of specification results reported.  There are no outstanding issues for this lot that would potentially affect product quality.  In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported.									Y	10/21/2008	10/21/2008	0		OTH	OTH		None	Seasonal Allergies		200814204	1						1	Body temperature increased; Discomfort; Erythema; Feeling hot; Hyperhidrosis; Hypoaesthesia; Immediate post-injection reaction; Injection site anaesthesia; Injection site pain; Paraesthesia; Skin warm	FLU3~CSL LIMITED~03549111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0337901	12/19/2008	WA	30.0	30		F	11/05/2008	Felt nauseous, dizzy, headache, right arm pain (injection arm). Report received on 10/21/2008. A 30 year-old female (D.P., DOB 07/12/1978) received AFLURLA IM at right deltoid on 21-Oct-2008 9:40am. AFLURLA lot number administered: 03549111A, exp date 30-Jul-2009. The patient had no illness at the time of vaccination and had no pre-existing allergies, or medical conditions. Patient is not taking and medication. At approximately 12:00pm on 21-oct-2008, patient started 12:00pm on 21-Oct-2008, patient started to feel nauseous, dizzy, complained of headache, and complained of right arm pain. The reporter considered the event as non-serious. No further information is expected.									U	10/21/2008	10/21/2008	0	N/A	OTH	OTH	NONE	NONE	NONE		200814201	1						1	Dizziness; Headache; Nausea; Pain in extremity	FLU3~CSL LIMITED~03549111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0337903	12/19/2008	VA	39.0	39		F	10/28/2008	Report received from a Registered Nurse (RN) on 20-OCT-2008.  An adult female patient (age and patient initials unknown) received a dose of AFLURIA (0.5 ml) from the pre-filled syringe at 3:00pm.  At 7:30pm, she experienced itching.  She felt itching on feet and it progressed all over her body.  There was some redness after she scratched.  One source other than the RN said the patient was showing hives.  Patient had no respiratory symptoms.  She went to the emergency room (ER) around 8:00pm and received BENADRYL as well as a prescription for PREDNISONE.  She left the ER at 9:00pm.  The next day patient stated that she was doing ok.  It is not known if the patient is allergic to any food or drugs.  Additional information has been requested.  No serious criteria mentioned.  Causality: Possible.  Follow-up information was received on 21-Oct-2008 from the RN.  The RN provided a few additional details.  The patient is an employee at the nursing home.  On 15-Oct-2008, AFLURIA was administered to all employees and residents at the nursing home.  The patient, is a 39 year-old female employee at the nursing home.  RN reiterated that subject experienced itching after vaccination.  She felt itching on feet and it progressed all over her body.  Patient is fine now.  Per the RN, approximately 240 doses were given and this was the only reaction.  RN did not consider this as an adverse reaction but rather a known side-effect from the vaccination.  No additional information is expected.  No change in assessment.  Information derived from this AE report does not change the current safety profile of the product.									Y	10/15/2008	10/15/2008	0		OTH	OTH		None			200814186	1						1	Erythema; Pruritus generalised; Urticaria	FLU3~CSL LIMITED~~1~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0337904	12/19/2008	TX	50.0	50		F	11/05/2008	Swelling under armpit, tenderness under armpit. A female patient received AFLURIA (prefilled syringe) on 15-Oct-2008 (PM) in the hospital and complained of swelling under the armpit on the morning of 17-Oct-2008 at 6:00 AM (06:00 hours). The injection was given in the left deltoid, IM injection. The nurse palpated the area and did not feel that a lymph node was involved, nor was any redness observed. The patient stated it feels tender. patient has allergies to sulfa and Tylenol(acetaminophen. Follow-up information was provided by patient and nurse on 20-Oct02008. The 50 year-old patient (DOB 11-Jan-1958) reports she is not yet recovered and that she is to visit with her physician on 20-Oct-2008. The patient reports she does not receive any other vaccinations within the past 4 weeks and reports no known pre-existing medical conditions. Patient had no illness at time of vaccination. Additional information has been requested.				Y					U	10/15/2008	10/17/2008	2	N/A	PVT	OTH	NONE	NONE	Allergy to sulfa; allergy to Tylenol; Family history of Lymphoma.		200814178	1						1	Axillary mass; Axillary pain	FLU3~CSL LIMITED~0274911A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0337905	12/19/2008	CA	60.0			F	10/01/2008	Fever(105F). Report received from physician on 03-Oct-2008. A 60 year-old patient received AFLURIA (batch number unknown) on 01-Oct-2008. The patient called the physician's office on 03-Oct-2008 to report a fever of 103 F. the patient consulted with the physician. Awaiting further information.									U	10/01/2008	10/03/2008	2		OTH	OTH					200814140	1						1	Pyrexia	FLU3~CSL LIMITED~~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0337906	12/19/2008	CA	88.0			U	12/01/2008	Report received from a physician on 03-OCT-2008.  An 88 year-old patient received AFLURIA (batch unknown) on 30-Sep-2008 and experienced a fever of about 103F within 2 days of administration (02-Oct-2008).  The fever resolved (date unknown).  Awaiting further information.  Serious criteria: None; Causality: The company assessed this case as possibly related.  Information derived from this AE report does not change the current safety profile of the product.									Y	09/30/2008	10/02/2008	2		OTH	OTH					200814139	1						1	Pyrexia	FLU3~CSL LIMITED~~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0335790	12/20/2008	WA	38.0	38		M	12/20/2008	Rash on chest and stomach.  Spots subsided but still visible 1.5 months after vaccine.  They are red and scaly.									N	11/07/2008	11/08/2008	1		UNK	UNK		None	Positive for tree pollens, grasses, molds, house dust mites, cats, dogs			1						1	Erythema; Exfoliative rash; Rash	FLU3~SANOFI PASTEUR~428494C~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331688	12/22/2008	TN	67.0	67		F	11/05/2008	Vaccinations on 10/29/2008. Pt states had vaccinations on 10/29/08. Pneumonia & flu on the R arm and Td on the L arm. On 11/4/08 in the pm pt states L arm started itching. That evening pt noticed that L arm was red, swollen, warm to touch, hurting and with a rash. On 11/5/08 pt calls the clinic with above complaints. Adivsed pt to come to clinic for further evalutions. On evaluation it was found that arm was red, swollen (area at 6x3 inches with 3mm elevation) warm to touch, itching and painful. Small milia-like shape bumps were also noticed. Pt was advised to place cold compresses on arm, take BENADRYL for itching and TYLENOL for the pain. Also advised pt that if symptoms got worse to go to the ER.									U	10/29/2008	11/04/2008	6		PUB	UNK		None	Codeine; Hyperlipidemia; Reflux; Cervicitis		TN08036	1						2	Erythema; Oedema peripheral; Pain in extremity; Pruritus; Rash; Skin warm; Erythema; Oedema peripheral; Pain in extremity; Pruritus; Rash; Skin warm	FLU3~SANOFI PASTEUR~u2772aa~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0038u~2~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~u2349cb~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U2772AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0038U~2~IM~RA~PNEUMO (PNEUMOVAX)~2|TD~SANOFI PASTEUR~U2349CB~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~2	USA		Influenza
0335822	12/22/2008	PA	59.0	59		F	12/17/2008	Initial report received on 17 November 2008 from a healthcare professional. A 59 year old female patient, with a history of high blood pressure, diabetes, hypothyroidism, hyperlipidemia, cervical disc disease, asthma, migraines and drug allergies (LIPITOR, CELEBREX, VITORIN, and TENEX), received on 26 September 2008 a left deltoid intramuscular injection of FLUZONE (lot number U2750AA). Immediately post vaccination, the patient had a hard lump at the injection site which lasted one week. The patient later developed (date not reported) a runny nose, pain above the injection site which radiated to the shoulder joint, a pulling sensation, and increased pain with lifting. The patient consulted a physician on 22 October 2008. The pain was not relieved with heat or ASA. At the time of the report, the pain had improved but it was unknown if it had completely resolved. Follow-up information was received 08 December 2008 from a health care professional. Upon review of follow-up information received, it was determined that this case meets seriousness criteria. According to the reporter, the patient complained the injection site was hard for one week following vaccination, then after resolved started with following symptoms lasting over two weeks. Corrective treatments consisted of warm soaks. TESSALON PERLE and ULTRAM. On 01 December 2008, the patient still had complaints of consistent pain in the deltoid and bursa area. The patient was seen by a chiropractor who provided treatment by ultrasound and the patient was planning to consult with a acupuncturist. Per the reporter, the patient was unsure of the manufacturer of the previous influenza vaccinations received in the past, however they had no complaints or known reactions following previous influenza vaccinations. The reporter offered to provide prior influenza vaccine lot numbers upon request. At the time of the report, the patient had not recovered from the event. Documents held by sender: None.				Y					N	09/26/2008	09/26/2008	0	Not reported	PVT	UNK			Allergic to LIPITOR, CELEBREX, VITORIN, and TENEX. History of high blood pressure, diabetes, hypothyroidism, hyperlipidemia, cervical disc disease, asthma, and migraines. No illness at the time of vaccination. No other vaccinations within 4 weeks prior. From information received 08 December 2008, no complaints or known reactions to previous influenza vaccinations.		200803628	1						1	Immediate post-injection reaction; Injected limb mobility decreased; Injection site induration; Injection site mass; Injection site pain; Musculoskeletal pain; No reaction on previous exposure to drug; Rhinorrhoea	FLU3~SANOFI PASTEUR~U2750AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335848	12/22/2008	TN	3.0	3		M	11/24/2008	Received FLUMIST Wed. 11-19-08. Began coughing that night. On Thursday cough had gotten worse. Thursday night child became pale, had difficulty breathing, was taken to local ED and transferred via ambulance to medical center. Treated with Albuterol, FLOVENT and Prednisolone. Temperature 101.4 (rectal) 1/2/09-ED records received for DOS 11/21/08-Presented with C/O difficulty breathing, fever intermittent for 2 days then began to have clear rhinorrhea/cough times 4 days prior to presentation. Increased respiratory rate, subcostal retraction, occasional wheeze.				Y	Y	1			Y	11/19/2008	11/19/2008	0	WBC; Blood cultures, chest x-ray; O2 Sats.  1/2/09-records received-CXR consistent with central peribronchial thickening, consistent with bronchitis, asthma or bronchopneumonia. WBC 15.9.	PUB	PUB	Prescribed Amoxicillin on 11-18-08 for otitis media	Saw PCP 11-18-08 for otitis media (taking Amoxicillin)	CECLOR Allergy; No previous hx of asthma; no health problems		TN08039	1						1	Blood culture; Body temperature increased; Cough; Dyspnoea; Oxygen saturation; Pallor	FLUN3~MEDIMMUNE VACCINES, INC.~500547P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0335850	12/22/2008	CA	56.0	56		F	12/22/2008	Patient complained the soreness of injection sites lasted until now. Some nights she couldn't sleep.									N	09/26/2008				OTH	UNK		None	None			1						1	Injection site pain; Insomnia	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335852	12/22/2008	NM	15.0	15		F	12/22/2008	Headache, occasional blurring vision, tingling numbness, dizziness.									U	11/26/2008	11/26/2008	0	CT head, CBC, CMP, T4, TSH	PVT	UNK	Allergra; Advair; Singulair	None	None			1						1	Blood thyroid stimulating hormone; Computerised tomogram; Dizziness; Full blood count; Headache; Hypoaesthesia; Metabolic function test; Paraesthesia; Thyroxine; Vision blurred	FLUN3~MEDIMMUNE VACCINES, INC.~500552P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB222AA~2~UN~LA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~0570X~3~UN~LA~HPV (GARDASIL)~1	USA		Influenza
0335853	12/22/2008	TN	49.0	49		F	11/05/2008	Patient called stating left side if neck was swollen at pneumonia and flu shot on 10-21-08. Asked patient to go to family Dr and to call and seeing him. patient called 10-23-08. States family Dr gave a cortisone shot and pain meds. Told to apply cold compress 20 min then off 10 min, then back on neck 20 min. Patient states pain is less and swelling is going away. Told by Dr and health dept to never take another pneumonia shot.				Y					U	10/21/2008	10/22/2008	1		PUB	UNK					TN08035	1						1	Local swelling; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~UA367EA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1344U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0335854	12/22/2008	TN	82.0	82		F	11/14/2008	Both hands broke out with raised red oval shaped papules, mostly on palmar surface of fingers and knuckles of right hand about 24 hours after vaccine, then within an hour or so, pt felt very weak, hurt all over, ached from scalp to toes, had chills and fever, no improvement , so saw PMD. 10/13 had X-ray of lungs, UA blood work and blood cultures 30 apart all negative. Frontal HA (headache) x 2 weeks, relieve with TYLENOL or ADVIL. No respiratory symptoms. Tired for the next month . Hands began to peel about 3 weeks after immunization, face swelled for about 2 weeks after immunization, lip looked like had been in a fight, red around eyes. Now 5 weeks after shot his slight fatigue and weakness of legs.				Y					N	10/09/2008	10/10/2008	1		PUB	PUB	LEXAPRO; BENAZEPRIL; PRILOSEC; TRIAMTERNE; SIMVASTATIN; MVI	None	Elevated BP and Cholesterol		TN08038	1						1	Asthenia; Blood culture negative; Blood test normal; Chest X-ray normal; Chills; Fatigue; Headache; Induration; Lip swelling; Ocular hyperaemia; Pain; Pyrexia; Rash papular; Skin exfoliation; Swelling face; Urine analysis normal	FLU3~SANOFI PASTEUR~U2810AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335857	12/22/2008	TX	49.0	49		F	10/14/2008	4:20 patient says, dizzy, arm on fire, burning and stiff, left arm. had 102 degree fever. 11 th and 12th noted lump size of lemon at injection site, tight and painful. Whole arm burning and very hot. 13th and 14th swelling extend to below elbow with redness and burning around arm. Also lump under armpit red and sensitive. Later blisters at injection site, itching at elbow. Patient said she put ice on the same. Follow up 11/21/08, patient went to the Emergency room and was given pain medication, and the Doctor informed her that she had an allergic reaction. She was given SULFADERM x 20 days, and instructed to apply alternately heat and cold. She stated that after two weeks she was better.				Y					Y	10/10/2008	10/10/2008	0		OTH	OTH	AMBIEN		Asthma; Heart valve defect			1						1	Axillary pain; Dizziness; Erythema; Hypersensitivity; Injection site mass; Injection site pain; Injection site swelling; Injection site vesicles; Lymphadenitis; Musculoskeletal stiffness; Pruritus; Pyrexia; Skin burning sensation; Skin warm; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88910~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0555U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0335859	12/22/2008	TX	59.0	59		F	10/13/2008	Patient reported, 10/11/08. Chills, body ache and fever 10/12/08  and Monday seemed to get worse. Left arm sore under arm, right hip pain, said can't get out of bed or move. Has hives on her face. Instructed her to contact her Doctor and requested that she contact me with update of her status. 11/15/08,11/17/08,11/19/08 and 11/21/08 attempted to contact her, left ,messages but without any response.									U	10/10/2008	10/11/2008	1		OTH	OTH	HBP Meds; Aspirin	Arthritis(treatment over the counter med).	HBP(High Blood Pressure)			1						1	Activities of daily living impaired; Arthralgia; Axillary pain; Chills; Pain; Pyrexia; Tenderness; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88910~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0335860	12/22/2008	TX	65.0	65		F	10/06/2008	Patient report, at 3:00pm noted neck / chest with redness, Injection site without redness or itching. She took atarax  1.0 mg at 3:40pm rash clearing. Patient used the Triamcinolone Ointment on neck and chest that seem to clear up the redness.									Y	10/06/2008	10/06/2008	0		PUB	OTH	Atarax, Triamcolone Acetonia 0	States, Recovery From reaction to Levaquin, for lupus, had hives on 08/07/08				1						1	Erythema; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88910~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0335861	12/22/2008	TX	21.0	21		M	09/25/2008	First time recipient of Influenza Vaccine, reported itching and small rash under eyes, patient monitored vital signs and went back to normal									Y	09/24/2008	09/24/2008	0		PUB	OTH	None	None	None			1						1	Pruritus; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88910~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0335862	12/22/2008	TX	72.0	72		F	10/17/2008	Patient reported: at 5:30 on 10/15/2008, fever 99.8, felt cold and had soreness at inj. site. 10/16/06: swelling at site and 2 below down to her elbow. at 0830 arm tight as drum. She called the ER, Recommend ice and Ibuprofen: 10/17/08: Dr visit says Lymphangitis with allergic reaction to vaccine. Treatment Keflex and Periactin.									Y	10/15/2008	10/15/2008	0		OTH	OTH	NONE		NONE			1						1	Feeling cold; Hypersensitivity; Injection site pain; Injection site swelling; Lymphangitis; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88910~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0555U~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0335863	12/22/2008	NE	1.1	1	.1	F	11/24/2008	Parent-please describe: 11/20/08- noticed red rash on left thigh, appeared larger (1/2 dollar) next day, itchy. Began to fade by 11/23/08.									Y	11/10/2008	11/11/2008	1	Mother states MD looked at Left thigh- stated tongue vaccine site.	PUB	PUB				low fever~Vaccine not specified (no brand name)~UN~0.50~In Patient		1						1	Injection site erythema; Injection site pruritus; Injection site rash	DTAP~SANOFI PASTEUR~U2356CA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~UT2783DA~1~IM~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB259AA~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0666X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C67963~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0485X~3~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0335866	12/22/2008	WI	18.0	18		F	12/18/2008	12/12/08 received TC from patient stating she is having a reaction to shots. Her lower right arm has a large bump about 4 cm. It hurts, is red, swollen and itches. Instructed to apply ice and take TYLENOL. 12/15/08 TC patient made to RN at child's school. She reports pt has no redness, swelling or probs with either arm.									Y	12/10/2008	12/12/2008	2		PUB	PUB	None	None	None			1						1	Erythema; Oedema peripheral; Pain in extremity; Pruritus	FLUN3~MEDIMMUNE VACCINES, INC.~500547P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB292AA~1~IM~LA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2818AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC25B029AA~2~IM~LA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~0593X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0335867	12/22/2008	MT	3.0	3		F	12/17/2008	7:00 am patient received flu nasal vaccine. 1 hour later patient complained of headache. Mom took temp 102 degrees, gave TYLENOL patient slept 1 hour, then woke crying complaining of headache. Mom gave another TYLENOL dose. Temp now 98.2 she called Dr office, Dr called her back 2 hrs later and patient was having leg aches. Dr instructed mom to give MOTRIN 4- 6 hours and TYLENOL x 24 hours. Patient felt better the next day, no more fever but did have emesis that night before. No more problems.									Y	11/19/2008	11/19/2008	0		PVT	PVT			None			1						1	Body temperature increased; Crying; Headache; Pain in extremity; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500560P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335870	12/22/2008	CA	1.2	1	.2	F	12/18/2008	Vaccines given at approximately 11:45 am, febrile seizure at 11:50 pm on 12-18-08. Spiked fever 102  and seen at local ER, chest X-ray and blood work WNL. Treated with MOTRIN.				Y					Y	12/17/2008	12/17/2008	0	All within normal limits	PUB	PUB						1						1	Blood test normal; Chest X-ray normal; Febrile convulsion; Pyrexia	DTAP~SANOFI PASTEUR~U2355BA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT27B6GA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~AD996~3~SC~UN~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0335871	12/22/2008	MA	77.0	77		F	12/18/2008	6 hours after injections severe chills, shaking, couldn't feel fingertips, temp. didn't register on thermometer (under 95 degrees), got under down comforter for 1 1/2 hours, began to warm up, then fever of 100 degrees lasting all night.									Y	12/05/2008	12/05/2008	0		PUB	UNK						1						1	Body temperature decreased; Chills; Hypoaesthesia; Pyrexia; Tremor	FLU3~CSL LIMITED~01249111A~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0335872	12/22/2008	MD	34.0	34		F	12/09/2008	Tightness in my chest and throat, SOB, swelling in my eyes. Fever, aches, chills, sweats, SOB and chest tightness lasted about 3 hrs, other symptoms until Monday 12/8									Y	12/06/2008	12/06/2008	0		PVT	PVT			Asthma			1						1	Chest discomfort; Chills; Dyspnoea; Eye swelling; Hyperhidrosis; Pain; Pyrexia; Throat tightness	FLU3~SANOFI PASTEUR~U283AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335876	12/22/2008	TX	76.0	76		F	12/12/2008	Patient reported immediate soreness at site of injection right deltoid, 10/12/08 noted increased soreness, no swelling. Two weeks after getting worse, increased pain,  #7 scale of 1-10. Pain now down elbow. Suggested that she visit her Doctor for evaluation and gave her our number to inform us of the outcome of that visit.									U	10/10/2008	10/10/2008	0		OTH	OTH			None			1						1	Arthralgia; Immediate post-injection reaction; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88910~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0555U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0335883	12/22/2008	SD	46.0	46		M	12/10/2008	Patient said he developed a deep chest cough, throat seemed a lttle tight, glands seemed puffy and tight and his eyes became very reddened and mattery.  Everything was fine the next morning.  Wondered if it could have beena recation to flu shot.  This was his first flu shot.  No other allergies.									Y	12/10/2008	12/10/2008	0		UNK	UNK						1						1	Cough; Eye discharge; Lymphadenopathy; Ocular hyperaemia; Throat tightness	FLU3~SANOFI PASTEUR~U2760AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335890	12/22/2008	MI	53.0	53		F	12/22/2008	Nasal congestion, cough, temp 100.9, chills sore throat									Y	12/11/2008	12/11/2008	0		UNK	UNK						1						1	Body temperature increased; Chills; Cough; Nasal congestion; Oropharyngeal pain	FLUN3~MEDIMMUNE VACCINES, INC.~500497P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335892	12/22/2008	PA	4.0	4		M	12/22/2008	Right thigh urticaria at site of injections.  Lungs clear.  Given Benadryl 1 1/2 tsp x1.  Rechecked after 20 minutes, rash resolved with exception of one hive at varivax administration site.  Decreased redness and size of hive.									U	12/22/2008	12/22/2008	0	none	PVT	PUB	NONE	NONE	NONE			1						1	Injection site erythema; Injection site urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B087AA~5~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2828AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB259AA~1~IM~LL~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~A04742~4~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0987X~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1186X~2~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0335893	12/22/2008	CA	3.0	3		F	12/22/2008	SMALL HEMATOMA (BLISTER) APPROXIMATELY 2CM IN DIAMETER ON LEFT THIGH.									N	12/17/2008	12/18/2008	1		PVT	PUB		NONE	NONE			1						1	Injection site haematoma; Injection site vesicles	FLU3~SANOFI PASTEUR~UT2794EA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB258AA~3~IM~RL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~C83143~4~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0335899	12/22/2008	CA	28.0	28		M	12/22/2008	Syncopal episode which occurred five minutes after intranasal vaccine was given.  This happened while patient was driving and resulted in an accident with no injuries, but car was totalled.				Y					Y	11/07/2008	11/07/2008	0		PVT	PVT	none	none	none	no~ ()~NULL~~In Patient|no~ ()~NULL~~In Sibling1		1						1	Immediate post-injection reaction; Road traffic accident; Syncope	FLUN3~MEDIMMUNE VACCINES, INC.~500566P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0335900	12/22/2008	MI	55.0	55		F	12/22/2008	patient complains of a swollen area where the injection was administered.  She stated that the injection hurt when administered.  She claims the area is very sore to the touch 1 month after the injection was given.									U	11/19/2008	11/19/2008	0	md advised her to use acetaminophen or ibuprofen	UNK	UNK	unknown	no	allergy to asa and nsaids			1						1	Injection site pain; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88117 6p~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0335908	12/22/2008	PA	57.0	57		M	12/22/2008	This case was reported by healthcare professional and described the occurrence of swollen glands under arms in a 57-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline) for prophylaxis. On the morning of 22-October 2008, the subject received a dose of FLUARIX (.5 unknown, unknown, left arm). On 24 October 2008. 2 days after vaccination with FLURIX, the subject experienced swollen glands under arms. ON 16 December 2008,  the subject experienced a reoccurrence frozen shoulder and decreased range of motion arm. A healthcare professional reported that a subject received FLUARIX on 22 October 2008 and two days later called to say that his left underarm had a swollen gland. He was treated with KEFLEX and the swelling resolved. On 16 December, his wife called this office to say that he had a reoccurrence and his left arm had decreased range of motion. He was treated at an orthopedic office and was told he had a frozen shoulder. He was given cortisone injections and physical therapy. The subject was treated with KEFLEX, CORTISONE and physical therapy. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related vaccination with FLUARIX. The orthopedist also mentioned to the subject's wife that this is the third case of frozen shoulder he has seen this year following flu vaccination. Additional cases see A0761286A and A0761289A.				Y					N	10/22/2008	10/22/2008	0	Unknown	OTH	PVT		Unknown	Concomitant medications and relevant medical history were unknown. The healthcare professional previously reported case A0665617A. The subject's orthopedist also mentioned to the subject's wife that this is the third case of frozen shoulder he has seen this year following flu vaccination. Additional cases see A.		A0761235A	1						1	Joint range of motion decreased; Lymphadenopathy; Periarthritis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA359CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0335909	12/22/2008		0.6	0	.6	F	12/22/2008	This female subject was enrolled in a study. On October 2008 and November 13 2008, she received the 1st and 2nd dose of THIMEROSAL free, FLUARIX or FLUZONE. This subject received FLUARIX 0.5ml. On 30 November 2008, 17 days after the 2nd dose of blinded vaccine, this eight-month-old subject developed cyanosis and apnea. The subject was hospitalised. The events resolved on 30 November 2008. The investigator considered that there was a reasonable possibility that the apnea and cyanosis may have been caused by investigational vaccine and that the events were possibly due to suspected gastroesophageal reflux (not proven). Investigator comments: Subject is an 8 month old female who entered the study on 8 October 2008. On 30 November 2008, 17 days after receiving the 2nd dose of study vaccine, the subject was admitted into the hospital due to an episode of apnea with cyanosis. As per mother, the subject has not had any previous occurrence of apnea. However, she reported that the subject has had a cough, congestion and Rhinorrhea on the day of the event. On admission, the subject was not in acute distress. Oxygen saturation was 99 %. Heart sounds had regular rate and rhythm. On lung examination, coarse breath sounds were heard. CBC, electrolytes and urinalysis results were within normal limits. CXR was done and showed no acute disease. Pneumogram study was done and was normal. No other episodes of apnea were observed while admitted. Subject was discharged after 3 days. Investigator believes there is a possibility that event is related to study vaccine. Other possible causes of event include gastroesophageal reflux (not proven).					Y	3			Y	11/13/2008	11/30/2008	17	Nasopharyngeal swab, RSV, Ag, EIA, 30,Nov,2008, negative; Oxygen saturation,30,Nov,2008,99%; Respiratory rate, 30,Nov,2008, 22bpm(beats per minute)	OTH	OTH		Unknown			R0001367A	1						1	Apnoea; Chest X-ray normal; Cough; Cyanosis; Full blood count normal; Laboratory test normal; Oxygen saturation normal; Respiratory syncytial virus test negative; Respiratory tract congestion; Rhinorrhoea; Urine analysis normal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0335910	12/22/2008	NJ	4.0	4		F	12/18/2008	Allergic reaction to vaccine consisting of erythematous area measuring 15 cm, very pruritic of (L) thigh. No fever. No tenderness.									Y	12/15/2008	12/16/2008	1	None	PVT	PUB	None	None	Asthma			1						1	Allergy to vaccine; Hypersensitivity; Injection site erythema; Injection site pruritus	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20R116AB~1~IM~LL~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~U2840AA~5~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1082X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1216X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0335912	12/22/2008	NM	4.0	4		M	12/18/2008	DTap (L) leg 12/7. 12/18 - presented with swelling pain (L) leg from site of vaccine to (L) knee. No fever, redness, from A/P. Local reaction, Rx Ibuprofen.									Y	12/17/2008	12/17/2008	0		PUB	PUB		None	None			1						1	Injection site pain; Injection site swelling; Local reaction	DTAP~SANOFI PASTEUR~C2957AA~5~IM~LL~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~5005660P~5~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~A1109~4~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1120X~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1225X~2~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0335913	12/22/2008	NC	6.0	6		M	12/22/2008	Received vaccines on 12/18/08. Played basketball on 12/20/08 on the night of 12/20/08 noticed left arm swelling no pain/tenderness.				Y					N	12/18/2008	12/20/2008	2		PVT	PVT				arm swelling~Influenza (Seasonal) (no brand name)~UN~5.00~In Patient		1						1	Oedema peripheral	FLU3~SANOFI PASTEUR~U2853AB~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB262AA~1~IM~LA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1275X~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0335917	12/22/2008	FL	0.6			U	12/22/2008	Rash itchy and urticarial. Scattered wheals. ORAPRED 15mg/5mg, 1/2 tsp BID.									Y	12/18/2008	12/19/2008	1		PVT	PVT						1						1	Rash pruritic; Urticaria	DTAP~SANOFI PASTEUR~C3081~UNK~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT278A~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF52A02~UNK~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~D16284~UNK~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1273X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0335918	12/22/2008	VA	34.0	34		F	12/22/2008	Patient presented at ER 11/07/08 with shortness of breath, swelling of lips, mouth, numbness of hands and face. She responded to 50 mg oral BENADRYL and was released. 12/02/08 and 12/03/08 she presented to ER with similar signs/symptoms but also hives, croupy cough she was given BENADRYL 50 mg by mouth then EPINEPHRINE 1:1000 0.3 ml sq and PREDISONE. Symptoms improved and she was released.				Y					Y	11/07/2008	11/07/2008	0	12/22/08 she was seen by an allergist who tested her with 1/10 influenza vaccine - same manufacturer and lot number. She had reaction again and was given EPINEPHRINE and put on steroids. Resolved	PUB	PVT	None	None	None known			1						1	Allergy test positive; Cough; Dyspnoea; Hypoaesthesia; Hypoaesthesia facial; Lip swelling; Oedema mouth; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~87877~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0335920	12/22/2008	CO	52.0	52		F	12/22/2008	10/23/08 injection shot hurt when given, muscle soreness, point of injection stayed red x3 wks, (and area) scab over point of injection-would bleed when scratched. Muscle stayed sore, painful to use hand x 2 mo. Seen by dR 12/17/08, antibiotic (KEFLEX) given and MOTRIN (800 mg) prn for discomfort. Much improved except not healed completely-remains sore in one spot.				Y					N	10/23/2008	10/24/2008	1	None	PUB	PVT		None	Allergic to oral steorids, anaprox			1						1	Injection site erythema; Injection site haemorrhage; Injection site pain; Injection site scab; Myalgia; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA173AA~2~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0335921	12/22/2008	MA	1.5	1	.5	F	11/14/2008	4 lesions in various stages including papules and 1 vesicle with onset 8 days after VARIVAX.									Y	10/22/2008	11/01/2008	10	None	PVT	UNK						1						1	Blister; Rash papular	DTAP~SANOFI PASTEUR~U2470AB~4~UN~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT279EA~3~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1002X~UNK~UN~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0335923	12/22/2008	CA	1.0	0	1	M	12/12/2008	Rash in face and trunk area, rash lasting 4 days									Y	11/12/2008	11/13/2008	1		PVT	PUB		None	None			1						1	Rash	FLU3~SANOFI PASTEUR~UT2794BA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335926	12/22/2008	OR	42.0	42		F	12/22/2008	Injection was given 12/8/2008. Patient notified pharmacy 12/22 at 9:40 am. Full body rash. Called Dr. Dr told her to take ZYRTEC and ZANTAC OTC.									U	12/18/2008	12/19/2008	1		OTH	PVT						1						1	Rash generalised	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA183AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0335930	12/22/2008	CT	1.6	1	.6	F	12/22/2008	Generalized hives within 24 hours of DTaP administration, concurrent with URI, no fever.				Y					Y	12/19/2008				PVT	PUB	None		None			1						1	Upper respiratory tract infection; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AC14B085BA~4~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0335931	12/22/2008	IA	2.0	2	.9	F	12/15/2008	HPI: Cough began 12/7/08 then persisted with worsening symptoms, including post tussive emesis x 1. PMHx: has had rare episode of RAD in past - last episode remote from FLUMIST administration on 11/11/2008. Acute symptoms. Have not had f up assessment as of yet.				Y					N	11/11/2008	12/07/2008	26		PVT	PVT	BACTRIM	None	RAD, 3 episodes x1, Jan, 2008, no reoccurrence; Vesicoureteral reflux	Bronchiolitis. Patient developed URI with cough and was evaluated and diagnosed with lower respiratory tract illness aith mild r		1						1	Cough; Post-tussive vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500570P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0335932	12/22/2008	TN	81.0	81		F	10/16/2008	patient received flu vaccine IM/LD and pneumonia vaccine IM/LD on 10-14-08 per LPN. patient returned to clinic on 10-16-08 with swelling, redness and tenderness in Lt arm from shoulder to elbow on front side only. Patient then tells nurse she had a reaction 6 yrs ago and had forgotten it was from a pneumonia shot. Instructed patient to put warm moist compresses, TYLENOL for pain and BENADRYL for allergic reaction. Will call clinic in am and relate progress, have been unable to reach patient for last 2 weeks.									U	10/14/2008	10/14/2008	0		PUB	PUB					TN08034	1						1	Erythema; Oedema peripheral; Pain; Tenderness; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~UA367EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1344U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0334887	12/23/2008	MA	30.0	30		F	12/19/2008	Seriousness Criteria: Other-Medically Significant. Initial report received on 10 December 2008 from a health care professional. A 30-year-old female patient, who had concurrent illness of TB Adenitis and allergies to many drugs (unspecified), had received an intramuscular left upper extremity injection of FLUZONE SV 2008-2009 (lot number U2798EA) on 12 November 2008. Two days after vaccination, the patient developed autoimmune plexography involving the right arm. It was not reported whether the patient required medical attention or evaluation by a physician, or if any diagnostic tests or laboratory data were performed. Treatments prescribed were not provided. The recovery status of the patient was also not provided. Documents held by sender: None				Y					U	11/12/2008	11/14/2008	2	Not reported	PVT	OTH		TB Adenitis	The patient had allergies to many drugs at the time of vaccination on 12 November 2008.		200803972	1						2	Autoimmune disorder; Nerve injury; Autoimmune disorder	FLU3~SANOFI PASTEUR~U2798EA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2798E~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0335771	12/23/2008	MN	45.0	45		F	12/23/2008	None stated.				Y					U	12/08/2008	12/10/2008	2	(12/19/2008) EMG and Nerve Conduction Velocity tests	OTH	PVT	None	None	Allergies to dogs, cats, horses			1						2	Asthenia; Dizziness; Electromyogram; Fatigue; Injection site pain; Nerve conduction studies; Pain in extremity; Paraesthesia; Electromyogram; Nerve conduction studies; Unevaluable event	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U2743AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0335940	12/23/2008	NY	10.0	10		M	12/18/2008	Subject received FLUZONE on 9/29/2008.  He began developing symptoms of transverse myelitis on 10/13 and even if these events could be completely unrelated I would prefer to file this report.  01/02/2009 PCP records received which include daily progress notes from hospital admission.  2/23/09 MR received for 2 admissions 10/14-12/23/2008 with D/C DX: Transverse Myelitis. Pt initially presented after onset of knee pain, numbness, paresthesias, weakness and difficulty ambulating. PE (+) for lack of crimasteric, patellar, and achilles reflex, inability to move lower extremities, loss of strength of LE, and (+) Babinski. Admitted for eval and tx.  Urology consult for urinary retention. pt to self cath. Tx: steroids and plasmapheresis. Developed spasticity and E. coli UTI during admission. Transferred to rehab on 12/3/08 with some improvement in sensation and movement.				Y	Y	81	Y	Y	N	09/29/2008	10/13/2008	14	On 10/15/08 subject had an MRI of the thoracic spine showed findings consistent with transverse myelitis.   Labs and Diagnostics:  Head CT WNL.  MRI spine initially  (-), later (+) for inflammation..  CSF glucose 78 otherwise LP WNL. CSF cx (-). No oligoclonal bands. Mycoplasma IgG (+) . UC (+) for E. coli. Viral studies all (-). MRI brain WNL. CXR WNL.	PVT	PVT	None	None	Reactive airway disease. PMH: none.			1						1	Myelitis transverse; Nuclear magnetic resonance imaging abnormal	FLU3~SANOFI PASTEUR~U2810AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0335942	12/23/2008	IL	19.0	19		F		None stated 1/2/09-records received for DOS 12/2/08-C/O rash on left side of back.DX: Chickenpox. Reaction to varicella vaccine. 12/8/08-lesions are now scabbed over.					Y	5			Y	11/20/2008	12/02/2008	12		UNK	UNK			1/2/09-records received-PMH: bilateral achilles tendinitis.			1						1	Unevaluable event	FLUN3~MEDIMMUNE VACCINES, INC.~500560P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB132AC~1~IM~LA~HEP A + HEP B (TWINRIX)~1|MMR~MERCK & CO. INC.~0915X~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|MNQ~SANOFI PASTEUR~U2670AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C29988AA~1~IM~RA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~0130X~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0335944	12/23/2008	CA	0.7	0	.7	M	12/17/2008	Rash in trunk and face (hives) 5 hours after injection given, and he also vomited x 2. When Dr examined pt., rash was gone.									Y	12/15/2008	12/15/2008	0	None	PVT	PUB						1						1	Rash; Urticaria; Vomiting	FLU3~SANOFI PASTEUR~UT2794EA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335945	12/23/2008	NC	1.7	1	.7	F	12/17/2008	No known adverse reaction.									Y	12/15/2008			None	PUB	PUB	TYLENOL	None	None			1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U2800EA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335949	12/23/2008	AZ	59.0	59		F	12/17/2008	Per pt., e-mailed about 11 pm that night (L) side began to get sore - (L) lymph nodes very tender and pain went down through the (L) side of ribs to pelvis. The site was hot, red, inflamed, and tender, could barely move (L) side was so sore and painful. Stayed in bed entire day - Sat., site still red, hot and sore. Sunday, getting back to normal.									Y	12/04/2008	12/04/2008	0		PUB	PVT	Unknown		Unknown			1						1	Injected limb mobility decreased; Injection site erythema; Injection site inflammation; Injection site pain; Lymph node pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89620~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0551X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0335950	12/23/2008	CO	47.0	47		F	12/09/2008	11/1/08, given flu shot high on left arm into joint, sore to begin with; and as of 12/1 developed into unmovable joint, unable to lift arm and disrupts sleep.									N	11/01/2008	12/01/2008	30	Pt. evaluated here. We are unsure if shoulder is related shot. X-ray taken (normal); Labs pending.	OTH	PVT		None				1						1	Drug administered at inappropriate site; Immediate post-injection reaction; Injected limb mobility decreased; Laboratory test; Sleep disorder; X-ray normal	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0335952	12/23/2008	IN	13.0			M	12/17/2008	24hr after vaccines he developed fever 103.2, stiff neck, bloodshot eyes, dizziness, nausea and couldn't lift his arms. He was not seen by medical personnel. Symptoms resolved in 2 days.									Y	11/03/2008	11/04/2008	1		PVT	PVT		None	None			1						1	Dizziness; Injected limb mobility decreased; Musculoskeletal stiffness; Nausea; Ocular hyperaemia; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500567P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U2687AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B024DB~1~IM~RA~TDAP (BOOSTRIX)~1	USA		Influenza
0335955	12/23/2008	NJ	7.0	7		M	12/17/2008	About 5 mins. after immunization, pt. developed erythematous, urticarial rash face, chest, back, arms, thighs. Pt. also vomited x1. BENADRYL 25 mg given. Observed for 45 mins. No resp. issues.									Y	12/13/2008	12/13/2008	0		PVT	PVT			Cleft lip and cleft palate			1						1	Rash erythematous; Urticaria; Vomiting	FLU3~SANOFI PASTEUR~U2768AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1279X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0335957	12/23/2008	WA	1.0	1	.0	M	12/16/2008	Pt has significant case (60 + lesions) of varicella (diagnosed clinically) which began 8 days after vaccine- ? Imm. reaction vs wild type disease. No secondary infection to date. Currently has sxs expect full recovery.									U	12/05/2008	12/13/2008	8	None (clinical diagnosis)	PVT	PUB		None	None			1						1	Varicella post vaccine	FLU3~SANOFI PASTEUR~UT27946A~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB258AA~1~UN~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1120X~1~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1320X~1~UN~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0335958	12/23/2008	NJ	68.0	68		F	12/15/2008	Pt recovered severe vomiting and diarrhea on 12/11/08 at appx 12AM x 4 hours. No fever or headache. Did not seek medical attention.									Y	12/09/2008	12/11/2008	2		PUB	PVT						1						1	Diarrhoea; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA176AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|TD~MASS. PUB HLTH BIOL LAB~A010B~UNK~IM~RA~TD ADSORBED (TDVAX)~1	USA		Influenza
0335961	12/23/2008	TN	11.0	11		M	12/15/2008	Redness and stiffness									Y	12/12/2008	12/12/2008	0		PVT	PVT		None	None			1						1	Erythema; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U2761AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2660BA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~UF455AA~1~IM~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~0515X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0335962	12/23/2008	CA	70.0	70		M	12/16/2008	This may have nothing to do with the vaccine, but in the interests of scientific fact gathering, I am reporting it. I developed a nasty case of Shingles (Herpes Zoster) on the left side of my face and scalp,with swelling around my forehead and eyes. I was given ACYCLOVIR and Prednisone by the Urgent care doctor on 11/16/08, and seen by my PCP on 11/17/08. By 11/27/08, symptoms were subsiding and by 12/16/08, I am almost completely ok. My pain and beginning symptoms started on 11/12/08.				Y					Y	11/10/2008	11/12/2008	2		OTH	OTH	LEVOXYL; Lisinopril	None	Sulfa drugs			1						1	Herpes zoster; Pain; Swelling	FLU3~SANOFI PASTEUR~U2849AC~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335964	12/23/2008	AZ	59.0	59		M	12/10/2008	Wife States had to go to state clinic and received a prescription for steroid. Had determined allergic reaction.				Y					U	12/03/2008	12/04/2008	1		PUB	PVT		None				1						1	Hypersensitivity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLAI55AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0335966	12/23/2008	GA	44.0	44		M	12/23/2008	Left shoulder and arm pain began immediately and has not resolved. Left arm/hand numbness and tingling began about 1.5 - 2 weeks after vaccine was administered. Orthopedist reported scarring in the deltoid and ordered physical therapy.  Neurology evaluation pending. Tdap and Flu given in left deltoid. MMR given in right arm.				Y					N	11/26/2008	11/26/2008	0	Xrays show scarring in deltoid.  MRI and nerve tests pending.	PVT	PVT	None	None	None			1						1	Hypoaesthesia; Immediate post-injection reaction; Musculoskeletal pain; Nerve conduction studies; Nuclear magnetic resonance imaging; Pain in extremity; Paraesthesia; Scar; X-ray abnormal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89748~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|MMR~MERCK & CO. INC.~0666X~UNK~SC~~MEASLES + MUMPS + RUBELLA (MMR II)~1|TDAP~SANOFI PASTEUR~C3032AA~UNK~IM~~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0335967	12/23/2008	MD	13.0	13		M	12/23/2008	PT FELT DIZZY, HAD COLD SWEATS, THEN BLACKED OUT; HAD TO BE CARRIED TO BACK TREATMENT AREA AND PLACED INTO GURNEY.  PT AWOKE IMMEDIATELY; VITAL SIGNS WERE STABLE; CHECKED OUT BY PHYSICIAN ON DUTY AND RELEASED AFTER ABOUT 45 MINUTES OF OBSERVATION.				Y					Y	12/23/2008	12/23/2008	0		MIL	MIL	DAYTRANA TRANSDERMAL PATCH					1						1	Cold sweat; Dizziness; Loss of consciousness	FLU3~SANOFI PASTEUR~U2793FA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335969	12/23/2008	TX	24.0			M	12/23/2008	Patient with PMH of asthma and significantly  elevated IgE 2159 was admitted with the right axilla pain after the pneumovax and flu shot in the right arm yesterday earlier during the day. He was also given Td in left arm.  Patient had equisitely tender anterior aspect of right  axilla when moving adducting and abducting the right shoulder. Patientwas seen by the neurology, general surgery and orthopedic teams, and was  also discussed with allergy immunology aeam. He was empirically given abx, pain meds and IVF. MRI of the right shoulder was obatined that confirmed cluster of enhancing masses in the right axilla most consistent with lymph nodes with surrounding mild inflammation. No abscess. Therefore, it was believed that patient has had reactive lymphadenitis to the immunization (flu, pneumovax) that he received in the right arm on 11/25/08.									Y					UNK	PUB	Advair 500/50, albuterol inhaler, loratadine, omalizumab 450 mg q2weeks, omeprazole, zolpidem	asthma	asthma			1						1	Blood immunoglobulin E increased; Lymphadenitis; Lymphadenopathy; Pain in extremity; Axillary pain; Inflammation; Injected limb mobility decreased; Lymphadenitis; Mass; Nuclear magnetic resonance imaging abnormal; Tenderness	FLU3~SANOFI PASTEUR~89297~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1287x~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~UNKNOWN MANUFACTURER~u23456~UNK~IM~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~89297~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~1287X~UNK~UN~RA~PNEUMO (NO BRAND NAME)~2|TD~UNKNOWN MANUFACTURER~~UNK~~LA~TD ADSORBED (NO BRAND NAME)~2	USA		Influenza
0335971	12/23/2008	NH	39.0	39		F	12/23/2008	after about an hour and a half chest felt heavy and started having trouble breathing				Y					Y	10/24/2008	10/24/2008	0		PVT	UNK		No illnesses known at time of vaccination.	Thalasemea, severely iron difficient			1						1	Chest discomfort; Dyspnoea	FLUX~UNKNOWN MANUFACTURER~~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0335974	12/23/2008	TN	4.0	4		M	12/23/2008	urticaria itching and mild edema within minutes after vaccines administered.vaccines given were:Dtap, MMR, IPV, Varicella, Flu.  Mom denied any previous reactions to vaccines.  denied allergies to meds.  Stated pt had allergies to strawberries, mangoes and grapes.Denied allergy to eggs.				Y					Y	12/22/2008	12/22/2008	0	none	UNK	PUB	none	no	none that we know of			1						1	Oedema; Pruritus; Urticaria	DTAP~SANOFI PASTEUR~C2955BA~4~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2898DA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0490-2~4~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0347X~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1145X~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0335976	12/23/2008	MN	4.0	4		M	12/23/2008	Mother reported 3 inch red pink area over where varicella vaccine was given.  Occured three days after administration and started to fade 6 days after administration.									Y	12/12/2008	12/15/2008	3		PVT	PVT		none	none			1						1	Injection site erythema	DTAP~GLAXOSMITHKLINE BIOLOGICALS~ac14b087aa~4~IM~RL~DTAP (INFANRIX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89297~4~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~a0805~1~SC~LL~POLIO VIRUS, INACT. (POLIOVAX)~1|VARCEL~MERCK & CO. INC.~0907x~2~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0335977	12/23/2008	MT	74.0	74		M	12/23/2008	Vaccine administered at annual mass influenza clinic setting. Patient notified HD on 12/16/2008 that he received flu vaccine and has had sore Left arm. Arm was a little sore prior to vaccination date, was a little more sore for a few days after the vaccine, but when the increased soreness did not abate, patient noticed. Reports decreased ROM: can assist left with right to reach full ROM. Mentioned to occasional provider, but has not informed regular MD. Reports no problems with prior influenza vaccine. Education to notify HCP re evaluation.									U	11/18/2008	11/18/2008	0	none to date; see note above	UNK	UNK		none, sniffles	reports has some bursitis related to years of occupation as mechanic, working with arms above head while reclining			1						1	Condition aggravated; Injected limb mobility decreased; No reaction on previous exposure to drug; Pain in extremity; Tenderness	FLU3~SANOFI PASTEUR~U2758AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0335984	12/23/2008	VA	1.09	1	.1	F	12/23/2008	I took patient on 11/28/08 to receive the second part of her flu shot and the MMR shot.  (The manufacturer, lot# and any other information is not listed on her shot records form for the Flu Vaccine for whatever mysterious reason).  On December 5, 2008, I took her to facility and saw Dr. because I thought she may have an ear infection.  Both ears were in fact infected and she was prescribed Amoxicillin which she started taking that day. Every other time she has had an ear infection, she improved significantly from the antibiotics within 24 hours.  By Sunday, she was still not showing any signs of improvement and was acting very out of character.  She is a very active baby and was walking but was very fatigued and we knew she did not feel well.  Instead of sending her to her regular babysitter on Monday, I decided to let her stay with her Grandmother so she could get good rest. I called facility and told them that the Amoxicillin was not working and asked if they would call in something different.  They said no and to wait three more days and if there was no improvement, then bring her back in.  At 12:30 p.m. that same day my mother in law called me and said that patient was dragging all day and would not walk and was very sleepy.  At 4:30 p.m. she called me back and said something was wrong with the baby and that she had had a seizure and the ambulance was taking her to hospital.  Please note that patient DID NOT have a fever.  She had not had one since Friday, December 5, 2008 and it was a very low grade temperature of 99.  When I got to the ER, patient was very out of sorts and not acting like my baby at all.  Out of control crying and screaming, throwing her body around and literally inconsolable.  Finally, after a couple of hours, she was finally winding down and to my surprise as I was rocking her, she had another seizure.  She had two to follow within 24 hours.  In all she had four seizures within 24 hours.  Every test you can think of was performed (EEG's including one for 48 hours, MRI, Spinal Tap, blood work, etc.) and they all came back clear.  After the 24 hour period she did not have another seizure and to date has not had another.  Dr. diagnosed her with epilepsy and put her on Trileptal.  I am in the process of taking her off of it because I am not sure that she now has epilepsy and do not want to medicate my child unnecessarily.  If she has another seizure when we take her off of it then we will cross that bridge when we get to it but I do not think that she will.  I truly believe that this was an adverse reaction to the MMR shot and possibly the flu vaccine as well.  All the doctors tell me no, but I do not believe that to be true.  I feel that this combination of shots is too much for these little ones to handle and she will NEVER again get the MMR booster.  Something is terribly wrong with that shot and no one believes the thousands of parents who have sat and watched this happen to their children. Must we put them all on unnecessary drugs and give them bogus diagnoses, or watch horrific or even fatal results before the government does something about it?  I will be very proactive about this.					Y	4			Y	11/28/2008	12/08/2008	10		UNK	UNK	None	N/A	N/A			1						1	Abasia; Abnormal behaviour; Blood test normal; Convulsion; Crying; Dyskinesia; Ear infection; Electroencephalogram normal; Emotional distress; Epilepsy; Fatigue; Lumbar puncture normal; Malaise; Nuclear magnetic resonance imaging normal; Pyrexia; Screaming; Somnolence	FLU3~SANOFI PASTEUR~UT2787AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0988X~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Hospitalisation	Influenza
0335985	12/23/2008	MI	10.0			M	12/19/2008	Initial report was received 10 December 2008 from a health care professional. A 10-year-old male patient with a history of asthma and an allergy to Advair discus, had received an intramuscular injection of FLUZONE SV 2008-2009, lot number U2809AA on an unspecified date and moments after vaccination, he passed out. The event lasted less than five minutes and the patient became alert and oriented with no deficits noted by the physician. The patient recovered from the event. The patient had a prior event where they passed out after receiving FLUZONE, lot number U2449AA last year. This event had been received as a cluster report. The patient experienced a previous event which was captured in case 2008-03955. Documents held by sender: None.				Y					Y				None	PVT	PVT	PULMACORT, ALBUTEROL, ZERTEC, NASONEX		The patient had no illness at the time of vaccination. Past medical history included asthma and an allergy to ADVAIR DISCUS. Concomitant medications included PULMACORT, Albuterol, ZERTEC, and NASONEX. The patient had not received any other vaccines during the four week prior to receipt of FLUZONE. The patient had a previous event where they passed out after receipt of FLUZONE last year.	Passed out~Influenza (Seasonal) (Fluzone)~UN~9.00~In Patient	200803954	1						1	Loss of consciousness	FLU3~SANOFI PASTEUR~U2809A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335986	12/23/2008	MI	9.0			M	12/19/2008	Seriousness Criteria: Other-Medically Significant. Initial report was received 10 December 2008 from a health care professional. A 9-year-old male patient had received an injection of FLUZONE SV 2007-2008, lot number U2449AA on an unspecified date last year and moments after vaccination, he passed out. Specific details were not reported for the event; however, the patient had experienced a subsequent event where they passed out following receipt of FLUZONE SV (captured in case 2008-03954). The subsequent events lasted less than five minutes and the patient became alert and oriented with no deficits noted by the physician. The patient recovered from the events. This event had been received as a cluster report. The patient experienced a subsequent event which was captured in case 2008-03954. Documents held by sender: None				Y					Y				Not reported.	UNK	UNK			The patient experienced a subsequent event where they passed out following receipt of FLUZONE during the 2008-2009 season (date of event not reported).		200803955	1						1	Loss of consciousness	FLU3~SANOFI PASTEUR~U2449A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335987	12/23/2008	CA				M	12/19/2008	Initial report was received 10 December 2008 from a health care professional. A male patient (age not reported) had received an intramuscular left deltoid injection of FLUZONE SV 2008-2009, lot number U2749AA on 08 December 2008 and the following day, he noticed a loss of sensation bilaterally in his hands and feet, a rash on the palms of his hands, blisters on two fingers of each hand, and a purple bruising on both fingers. According to the reporter, the physician had prescribed PREDNISONE that day for an unknown reason. The patient had not recovered from the event and no further information was provided at the time of the report. Documents held by sender: None.				Y					N	12/08/2008	12/09/2008	1	Not reported	UNK	UNK			Not reported		200803963	1						1	Blister; Contusion; Rash; Sensory loss	FLU3~SANOFI PASTEUR~U2749AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0335993	12/23/2008	CA	11.0	11		M	12/17/2008	Reported that 11-year old male patient received the vaccines below. Presented to physician office today c/o bilateral weakness in both upper and lower extremities. Diagnosed as possible GBS and sent to hospital. 12/29/2008 MR received from PCP which include hospital records for DOS 12/17-20/2008 with D/C DX: weakness in limbs. Admitted from PCP office to r/o GBS due to onset of weakness 3 weeks ago which required help with ambulation and 1 episode of bladder incontinence. Some resolution on it's own, but still with intermittent episodes of weakness, requiring help with ambulation. Now with h/A, persistant pain in knees, legs and thighs and mild SOB.  PE (+) for decreased strength, borderline patellar reflexes.    F/U visit to PCP on 12/24/08-no muscle weakness. 1/15/2009 MR received for DOS 12/17-20/08 with D/C Dx: Weakness in limbs. Pt presented with intermittent weakness and pain. W/U (-).  Pain much improved.  Weakness unchanged. D/C to f/u with PCP.					Y	3	Y		N	11/03/2008	12/17/2008	44	Labs and Diagnsotics:  MRI brain and spine (-). CSF studies all WNL-viral cx (-), oligoclonal bands (-).. Head CT (-).  ESR 28.  AST 114.  ALT 159. IgA 251 (H). IgE 357 (H). CT brain scan (-). CBC WNL.	PVT	PVT	FLONASE; Loratadine 10 mg BID	None	Allergic rhinitis; has rcd allergy tests.  PMH:  asthma.  GERD. NKDA.			1						1	Muscular weakness; Guillain-Barre syndrome; Muscular weakness	FLU3~SANOFI PASTEUR~U2008AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2662AA~UNK~IM~LL~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC525028AA~UNK~IM~RL~TDAP (BOOSTRIX)~1|FLU3~SANOFI PASTEUR~U2808A~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|MNQ~SANOFI PASTEUR~U2662A~UNK~IM~LL~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B028AA~UNK~IM~RL~TDAP (BOOSTRIX)~2	USA	Hospitalisation	Influenza
0335994	12/23/2008	KS	0.5	0	.5	F	12/16/2008	12-15-2008 Hospitalized for fever- max 103.3, rectal, diarrhea with some blood in the  stool. Stool culture grew out Salmonella. Patient was then treated with bactrim and recovered. 12/31/08-records received  for DOS 12/15-12/16/08-DC DX: Fever and Salmonella gastroenteritis. Presented to ED with 3 day history of fever, cough and hematochezia which developed morning of admission. Fussy. Blood in stool.					Y	1			Y	12/12/2008	12/12/2008	0	Barium enema neg for intussusception  12/31/08-records received-Barium enema ruled out intussusception. Stool culture positive for Salmonella. WBC 16.7.	PVT	PVT	TYLENOL infant drops	None	None			1						1	Barium enema normal; Culture stool positive; Diarrhoea; Haematochezia; Pyrexia	DTAPIPVHIB~SANOFI PASTEUR~C3176AA~1~UN~UN~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~127599~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~D162484~3~UN~UN~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1461X~3~SC~UN~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0335995	12/23/2008	PR	46.0	46		M	12/23/2008	History of gout (ankles, feet, knees) since 1997. Diagnosed with tendonitis in ankles 2003; 2003/2004  increased pain in wrists/elbows. Diagnosed with tennis elbow. 2007 right ankle pain. Began to have headaches in 2005--stabbing pain around his eyes which lasted for hours, no nausea, vomiting, photophobia or visual changes. Treats with TYLENOL with relief. Has not sought medical care. Since 2003/2004 has had pimples in his hair. Since 1997 has suffered from nervousness and a bad temper.										02/14/2003			RBC, 4.7 X 10-6; SEGS%, 55.5%; MPV, 10.4 fL; PLT, 162 X 10-3; RDW-CV, 14.8%; MCHC, 33.1 gm/dl; MCH, 33.8 uug; MCV, 92.6 fL; HCT, 48.1 %; HGB, 15.9 g/dL; BASO ABSOLUTE#, 0.04 X 10-3; EOSINO ABSOLUTE#, 0.80 X 10-3; MONOS ABSOLUTE#, 0.52 X 10-3; LYMPHS ABSOLUTE#, 1.43 X 10-3; SEGS ABSOLUTE#, 3.48 X 10-3; BASO%, 0.6%; EOSINO%, 12.8 %; MONOS%, 8.3 %; LYMPHS%, 22.8 %; WBC, 6.2 X10-3; 02May08, ALK PHO, 62 U/L; BILIRUBIN, TOTAL, 0.7 MG/DL; eGFR, 58 mL/min; CREATININE, 1.3 M/L; CALCIUM, 9.5 MG/DL; ALBUMIN, 4.8 G/DL; PROTEIN,TOTAL, 7.4 G/DL; TSH, 3.330 uIU/mL; UREA NITROGEN, 18.3 mg/dL; GLUCOSE, 102 mg/dL; CO2, 28.6 mEq/l; CHLORIDE, 96 mEq/l; POTASSIUM, 4.9 mEq/l; SODIUM, 137 mEq/L; SGPT, 39 U/L; SGOT, 23 U/L; 23Jan08, WBC, 6.9 X 10-3; LYMPHS ABSOLUTE#, 1.69 X 10-3; SEGS ABSOLUTE#, 4.17 X 10-3; BASO%, 0.1 %; EOSINO%, 6.9 %; MONOS%,  7.6 %; LYMPHS%, 24.6 %; SEGS%, 60.8 %; MPV, 10.6 fL; PLT, 149 X 10-3; BASO ABSOLUTE#, 0.47 X 10-3; EOSINO ABSOLUTE#, 0.47 X 10-3; MONOS ABSOLUTE#, 0.52 X 10-3; HCT, 44.5 %; MCV, 92.7 fL; MCH, 32.7 uug; RDW-CV 12.7 %,; MCHC, 35.3 gm/dL; HGB, 15.7 G/dL; RBC, 4.8 X10-6; 23Jan08,  CHLORIDE, 101 mEq/L; POTASSIUM, 4.5 mEq/L; SODIUM, 139 mEq/L; SGPT, 26 U/L; SGOT, 16 U/L; ALK PHO, 70 U/L; BILIRUBIN, TOTAL, 0.6 MG/DL; eGFR, 62 mL/min; CREATININE, 1.3 MG/DL; TSH, 2.890 uIU/mL; UREA NITROGEN, 15.3 mg/dL; GLUCOSE, 107 mg; CO2, 26.3 mEq/L;URIC ACID, 8.5 mg/dL; CHOLESTEROL, 157 MG/DL; CALCIUM, 8.9 MG/DL; ALBUMIN, 4.4 G/DL; PROTEIN, TOTAL, 7.4 G/DL; 17Dec07, CT LOWER EXTREMITY W/O CONT, Reason for Order: PT PRESENTS WITH CHRONIC ANKLE PAIN, ESPECIALLY UPON AMBULATION. R/O SUBCHONDRAL FRACTURE B/L ANKLE JOINT. Findings: The left talus reveals a 4mm x 3mm osteochondral lesion involving the lateral aspect of the dome. There also minute soft tissue calcification projecting both lateral and medial to the talus in the mid dissection area probably related to previous ligamentous injury. The talotibial joint space is well maintained. The tibial plafond is intact. The talonavicular, calcaneocuboid, and subtalar joints are unremarkable. An ostrigonum is present. No tarsal coalition is observed. Normal trabecular rarefaction is seen in the midsection of the calcaneus. The right ankle shows no osteochondral lesions. The tibiotalar joint is unremarkable. An ostrigonum is noted. There is also what appears to be an accessory ossification center projecting lateral to the talus and anterior to the tip of the lateral malleolus. The medial malleolus is unremarkable. Normal trabecular rarefaction is also noted in the calcaneus. IMPRESSION:1. Pariarticular soft tissue calcifications which are probably related to previous ligamentous injuries. 2. Osteochondral lesioln involving the lateralaspect of the left talar dome. (Osteochondritis Dissecans).; 06Aug07, Right Foot (AP, LATERAL OBLIQUE), Reason for Order: PT HAS SUDDEN RIGHT FOOT SWELLING AND PAIN, Findings: Small spurs at the insertion of the plantar aponeurosis and Achilles tendon. No fracture, dislocationor bony lesions. Degenerative changes at the toes,; IMPRESSION: 1. Calcaneal spurs. 2. Degenerative changes.	UNK	UNK	VALIUM	depression; sleep disorder; anxiety; back pain; foot trouble; swollen painful joints; knee trouble; history of headaches	depression; headaches; hypertension; multiple joint complaints; gout			1						1	Acne; Alanine aminotransferase normal; Arthralgia; Aspartate aminotransferase normal; Basophil count normal; Basophil percentage decreased; Blood albumin normal; Blood alkaline phosphatase normal; Blood bilirubin normal; Blood calcium normal; Blood chloride decreased; Blood cholesterol normal; Blood creatinine normal; Blood glucose normal; Blood potassium normal; Blood sodium normal; Blood thyroid stimulating hormone normal; Blood urea normal; Blood uric acid normal; Carbon dioxide normal; Computerised tomogram abnormal; Condition aggravated; Eosinophil count increased; Eosinophil percentage increased; Epicondylitis; Haematocrit normal; Haemoglobin normal; Headache; Lymphocyte count normal; Lymphocyte percentage; Mean cell haemoglobin concentration increased; Mean cell haemoglobin normal; Mean cell volume normal; Mean platelet volume normal; Monocyte count normal; Monocyte percentage; Neutrophil percentage; Platelet count normal; Protein total normal; Red blood cell count normal; Red cell distribution width increased; Tendonitis	ANTH~UNKNOWN MANUFACTURER~~UNK~SC~UN~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~SC~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~IM~UN~HEP A (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~SC~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|MNQ~SANOFI PASTEUR~~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1|SMALL~UNKNOWN MANUFACTURER~~UNK~ID~UN~SMALLPOX (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~IM~UN~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~UNK~SC~UN~VARICELLA (NO BRAND NAME)~1|YF~UNKNOWN MANUFACTURER~~UNK~SC~UN~YELLOW FEVER (NO BRAND NAME)~1	USA		Influenza
0335997	12/23/2008	MD	9.0	9		F	12/17/2008	Redness, swelling, rash at injection site									Y	12/15/2008	12/15/2008	0	None	MIL	MIL	Risperidone	None	Autism - Allergies to penicillin, Roephin Azithromycin			1						1	Injection site erythema; Injection site rash; Injection site swelling	FLU3~SANOFI PASTEUR~112733AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHVA13289CB~1~IM~LA~HEP A (HAVRIX)~1	USA		Influenza
0335998	12/23/2008	IL	60.0	60		M	12/17/2008	muscle soreness in rotator cuff area. Inability to life arm to full extension.									U	11/23/2008	11/24/2008	1		OTH	PVT	LISINORPIL 20 mg	No	High Blood Pressure			1						1	Injected limb mobility decreased; Myalgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA198BA~1~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0336000	12/23/2008	TX	24.0	24		F	09/25/2008	chills, fever, body aches, congestion, chest tightness										09/24/2008	09/24/2008	0	None	PVT	UNK			None			1						1	Chest discomfort; Chills; Nasal congestion; Pain; Pyrexia	FLU3~SANOFI PASTEUR~C2744AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336001	12/23/2008	TX	41.0	41		F	09/25/2008	Body aches, chills, sneezing, coughing, tightness in chest.									U	09/25/2008	09/25/2008	0		PVT	OTH		None	None			1						1	Chest discomfort; Chills; Cough; Pain; Sneezing	FLU3~SANOFI PASTEUR~U2744AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336002	12/23/2008	NY	64.0	64		M	12/18/2008	Diffuse myalgias,fever, cough beginning 2 days after vaccine and worsening times 5 days.									U	12/11/2002	12/15/2008	2196	CBC with diff ; Lytes; BUN; CK; SGAT; LDH; Nasal Flu Swab	PVT	PVT						1						1	Aspartate aminotransferase; Blood creatine phosphokinase; Blood electrolytes; Blood lactate dehydrogenase; Blood urea; Cough; Culture; Differential white blood cell count; Full blood count; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U2757AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336003	12/23/2008	GA	24.0	24		F	12/13/2008	Had hives around TB test site after 2 days, and at 3 days had red bumps on forehead and across nose and cheeks. No swelling or raised areas.									Y	11/15/2008	11/17/2008	2		MIL	MIL	Pt was on antibiotic for tooth extraction; IPPD, C2812AA, intradermal	None	None			1						1	Rash; Rash erythematous; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500557P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~MERCK & CO. INC.~AHAVBN7AB~UNK~IM~UN~HEP A (VAQTA)~1	USA		Influenza
0336004	12/23/2008	MO	66.0	66		F		7 hrs after Flu shot developed 102 degrees F fever. Severe aches and pains. 36 hour duration of symptoms.									Y	12/08/2008				OTH	OTH	Synthroid; Premarin	None				1						1	Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0336007	12/23/2008	VA	70.0	70		M	10/13/2008	Patient has rash that is red and itchy it covers his arms and chest									U	10/09/2008	10/10/2008	1		OTH	PUB	Unknown	Unknown	Unknown			1						1	Rash; Rash erythematous; Rash pruritic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0336008	12/23/2008	MI	85.0	85		F	12/18/2008	Severe local reaction.				Y					Y	12/15/2008	12/16/2008	1		PVT	PVT		None	HTN; hyperparathyroidism			1						1	Local reaction	FLU3~SANOFI PASTEUR~U2743AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1021X~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0336027	12/23/2008	TX	1.0	1	.0	F	12/23/2008	erythema, vesicular eruption at injection site (L) thigh									Y	12/12/2008	12/16/2008	4	None	PVT	PVT		None	None			1						1	Injection site erythema; Injection site vesicles	FLU3~SANOFI PASTEUR~UT2788FA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB234BA~1~IM~RL~HEP A (HAVRIX)~1|HIBV~SANOFI PASTEUR~UF515AA~4~IM~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0985X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1225X~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0336028	12/23/2008	OR	65.0	65		M		(Nausea 2days) Chills 2 days  (left arm soreness and rash  10 days, 1 week)										10/20/2008	10/21/2008	1		PVT	PVT		None	Clantin			1						1	Chills; Nausea; Pain in extremity; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFWA388BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0867X~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0336031	12/23/2008	CA	11.0	11		F	12/23/2008	Client received vaccines listed below-Advised to remain seated while paper work was being filled in and signed. I noticed patient sliding down in her chair she became very pale. I assisted her to sit up in the chair advised her to lower her head and she did-I applied ice pack advising her to take slow deep breaths which she did client agreed to lie down. Take to clinic area per co-worker where checked by physician.				Y					Y	12/22/2008	12/22/2008	0		PUB	UNK		None	NKDA			1						1	Inappropriate schedule of drug administration; Pallor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89985~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~MERCK & CO. INC.~1884U~3~IM~RA~HEP B (RECOMBIVAX HB)~1|HPV4~MERCK & CO. INC.~0279X~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2617AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~1143X~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0336032	12/23/2008	CA	56.0	56		F	11/14/2008	Local-soreness, pain, swelling, redness. Systemic-lethargy-general malaise-mouth and throat soreness.									Y	11/12/2008	11/13/2008	1	None	PUB	PUB	Unknown	None	None		CA080023	1						1	Erythema; Lethargy; Local reaction; Malaise; Oral pain; Oropharyngeal pain; Pain; Swelling	FLU3~SANOFI PASTEUR~U2799AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336033	12/23/2008	CA	33.0	33		F	11/14/2008	headache/Body ache/ vomiting, sore arm									Y	11/12/2008	11/13/2008	1		PVT	UNK		None	None			1						1	Headache; Pain; Pain in extremity; Vomiting	FLU3~SANOFI PASTEUR~U279AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336034	12/23/2008	CA	45.0	45		M	11/14/2008	3 hours of sweats severe myalgias chills, relieved by acetaminphen, 12 hours after vaccination.									Y	11/12/2008	11/13/2008	1	None	PVT	PUB	Unknown	None	None		CA080021	1						1	Chills; Hyperhidrosis; Myalgia	FLU3~SANOFI PASTEUR~U2799AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336035	12/23/2008	CA	50.0	50		F	11/14/2008	No symptoms for me just a sore Rt arm.									Y	11/12/2008	11/13/2008	1	None	PVT	PUB	Unknown	None	None		CA080020	1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2799AA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336036	12/23/2008	CA	28.0	28		F	11/19/2008	Nausea and vomiting									Y	11/12/2008	11/12/2008	0	None	PVT	PUB	birth control	None	None		CA080019	1						1	Nausea; Vomiting	FLU3~SANOFI PASTEUR~U2799AA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336037	12/23/2008	CA	23.0	23		F	11/14/2008	Nausea and body aches.									Y	11/12/2008	11/13/2008	1		PVT	PUB	No	None	None		CA080018	1						1	Nausea; Pain	FLU3~SANOFI PASTEUR~U2799AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336038	12/23/2008	CA	42.0	42		F	11/03/2008	Above individual called the health center and said had a reaction after vaccinated with FLUZONE. C/O flushed face tingling and itching, coughing wheezing stridor. Onset 3 hrs after shot rec'd sx lasted 12 hours she did not seek medical attn. She took 2 puffs of a cumavent inhaler x 3 that belonged to her client. Sx improved but still coughing. Health center consulted pt advised to go to ER for eva. and follow up with MD. Pt ate at BD party at 1pm. 11/1/08.				Y					Y	11/01/2008	11/01/2008	0		OTH	PUB	Trivaris	None	Mitral Valve prolapse		CA080017	1						1	Cough; Flushing; Paraesthesia; Pruritus; Stridor; Wheezing	FLU3~SANOFI PASTEUR~U2748AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0336039	12/23/2008	CA	2.0	2	.0	F	12/22/2008	Cellulitis of thigh.				Y					U	12/19/2008	12/20/2008	1		UNK	UNK						1						1	Injection site cellulitis	FLU3~SANOFI PASTEUR~UT2982CA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AC14B087CA~UNK~IM~RL~HEP A (HAVRIX)~1|HIBV~SANOFI PASTEUR~UF533AB~UNK~IM~RL~HIB (ACTHIB)~1	USA	Emergency room visit	Influenza
0334611	12/24/2008		19.0			F	12/23/2008	Initial and follow-up information has been received for a direct report from the government(VAERS#334611) concerning a previously healthy 19 year old female happy achieving college freshman with no history of substance abuse, alcohol intake, or depression, or other mental health issues, who was vaccinated on approximately 28-NOV-2008 with a dose of GARDASIL, lot number not reported. Concomitant therapy included: meningococcal vaccine (unspecified). It was reported that on 08-DEC-2008, the student died suddenly, approximately 10 days after receiving GARDASIL and meningococcal vaccine (unspecified). The vaccines were administered by a medical provider in her hometown, while she was home for the Thanksgiving holiday. The student emailed campus health services on Sunday night (07-DEC-2008) complaining of dizziness, headache, and nausea. Student Health Services at her University indicated that it might be a seizure, and arranged an appointment for her to be seen in the health services clinic that Monday (08-DEC-2008) (the day of her death). The medical clerk had entered possible seizure as the reason for making the appointment. There was no referral to an Emergency Room (ER). She had no history of epilepsy. She complained of a headache and not feeling well in the 24 hours prior to her death. She went to be at 10:30 PM on 07-DEC-2008, in her dorm room with a roommate. She appeared to still be sleeping the next morning when her roommate left for class. Her body was discovered still in bed around 5:00 PM that day (08-DEC-2008) with rigor mortis. Follow-up information reported that the county medical examiner reported that examinations performed Dec. 9 were inconclusive, but said there were no signs of foul play and no signs of meningitis or other life threatening infectious diseases. Further tests would be performed and it may take up to six weeks for a final determination. This was originally reported by a physician. Additional information has been requested.	Y	12/08/2008							N	11/28/2008	12/07/2008	9	Unknown	OTH	OTH			Unknown		WAES0812USA02288	1						3	Autopsy; Death; Headache; Malaise; Autopsy; Death; Headache; Malaise; Death; Dizziness; Headache; Malaise; Nausea	FLUN3~MEDIMMUNE VACCINES, INC.~500569P~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0070X~3~~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2730AA~UNK~~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|HPV4~MERCK & CO. INC.~~UNK~UN~UN~HPV (GARDASIL)~2|MEN~UNKNOWN MANUFACTURER~~UNK~UN~UN~MENINGOCOCCAL (NO BRAND NAME)~2|HPV4~MERCK & CO. INC.~~UNK~UN~UN~HPV (GARDASIL)~3|MEN~UNKNOWN MANUFACTURER~~UNK~UN~UN~MENINGOCOCCAL (NO BRAND NAME)~3	USA	Results in Death	Influenza
0336009	12/24/2008	TX	7.0	7		F	12/05/2008	Papular rash on bridge of nose and around upper lip. Entire chin is red in circular pattern. No swelling of lips, no symptoms related to mouth or airway. No swelling of tongue or throat.									Y	12/04/2008	12/05/2008	1	Seen by MD. 12/15/08 @ 11:10am	PVT	UNK		None	None			1						1	Erythema; Rash papular	FLUN3~MEDIMMUNE VACCINES, INC.~50057P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0336044	12/24/2008	IL	20.0	20		M	12/15/2008	See attached progress notes. 12/29/2009 MR received for 2 office visits.  Pt presented 11/6/08 with c/o bilateral extremity weakness, weakness of the hands and feet and ataxia, difficulty walking and numbness to the abdomen. Recently tx for Community Acquired Pneumonia 11/2/08. PE (+) for rhonchi, decreased strength in arms, legs and hips, weakness both ankles, ataxic gait and diminished or absent reflexes. Assessment:  Muscle weakness-hands and feet x 2 days with truncal numbness.  No resp issues.  Sent to Er to r/o GBS.  Community acquired pneumonia. Labs and Diagnostics: CXR WNL. CBC with Hgb 36.6.  Hct 12.6.  Platelets 445. F/U visit for DX: Guillain-Barre Syndrome 11/25/08.  Pt reports still feeling weak, having trouble walking, paresthesias in legs, facial numbness. Unable to open mouth or close R eye. PE (+) for mild R peripheral VII paresis. DX:  Bell's Palsy. F/U 12/2/08 Sx improving but not completely resolved. 2/11/09 MR received for DOS 10/29-11/2/2008, 11/7-12/2008 and 11/12-20/2008 with initial DX of Pneumonia then Guillain Barre Syndrome. Pt initially presented with 5 day hx of worsening cough with yellow sputum, nasal congestion, vomiting and chills. DX with pneumonia and treated with abx.  Also reported knee and ankle pain. Infiltrates improved with abx and d/c on 11/2/08.  Returned 11/7 with c/o numbness/tingling  in his fingers and feet progressing to the thighs and difficulty walking.  Admitted and tx with IVIG with improvement. Able to walk with cane. Transferred for further rehab 11/12/08.					Y	18			Y	10/08/2008	10/24/2008	16	Labs and Diagnostics:  CXR (+) for LLL infiltrates.  UA (+) for many WBCs-no sx of UTI.  Head CT (+) for small subarachnoid cyst, pansinusitis, deviated nasal septum and hypertrophy of adenoid. Mycoplasma pneumonia IgG (+) at 4.05, IgM (-).  CMV IgG (+), IgM (-). EBV IgG and IgM (+). EMG/NCS (+) R common peroneal nerve. Knee X-ray (-).  CBC with WBCs 11.5-14.8 with PNA then WNL. ABGs abnormal. UC (+) for Staph and Diptheroids. Blood cx (-). EKG WNL.	MIL	MIL			PMH: none			1						1		FLUN3~MEDIMMUNE VACCINES, INC.~500560P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB129AB~1~IM~LL~HEP A + HEP B (TWINRIX)~1|MMR~MERCK & CO. INC.~0356X~1~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|TDAP~SANOFI PASTEUR~C2998BA~1~IM~LL~TDAP (ADACEL)~1	USA	Hospitalisation	Influenza
0336045	12/24/2008	IL	18.0	18		M		See attached progress notes patient is still hospitalized as of see 3/2008.  He is on a ventilation recently complicated by aspiration pneumonia. 12/29/08-records received-C/O fever, chills, congestion, runny nose, sore throat, nausea and productive cough, febrile on 10/6/08-DX:upper respiratory infection. fever. 10/15/08-C/O numbness of feet and numbness of hands and mouth. Assessment:polyneuropathy idiopathic progressive. 10/16/08-developed progressive neurologic symptoms consistent with GBS. Stable. 10/20/08-In rehabilitation center neuro symptoms not progressing. GBS not confirmed. 2/9/09-records received for DOS 10/15-11/13/08-DC DX:Guillain Barre syndrome with respiratory failure requiring ventilator support. HCAP. Presented with C/O tingling in feet bilaterally and in both hands and roof of mouth, weakness in lower extremities while trying to go upstairs. Aphonia, dysphagia. Acute sensory motor neuro deficit, respiratory ventilator and subsequent tracheostomy. IVIG and plasmapheresis. Developed orchitis. Tachycardia and hypertesion.					Y	28	Y		U	09/22/2008	10/06/2008	14	2/9/09-records received-CT head and MRI head normal. CXR infiltration. Electrodiagnostic studies abnormal-non-recordable latency of bilateral phrenic motor nerves and highly suggestive of acute demyelinating and axonal polyneuropath predominately involving motor nerves.. Reticulocyte count increased, hyperbilirubinemia.Suggest hereditary hemolytic anemia vs severe sepsis as cause of hemolysis.Echocardiogram normal. WBC 27.2	UNK	UNK		2/9/09-records received-Ten days prior had upper respiratory tract infection which resolved after 4 days.				1						1	Mechanical ventilation; Pneumonia aspiration	BCG~UNKNOWN MANUFACTURER~52064~1~IM~~BCG (NO BRAND NAME)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500560P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHAB128AB~1~IM~LL~HEP A + HEP B (TWINRIX)~1|MMR~MERCK & CO. INC.~0356x~1~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|MNQ~SANOFI PASTEUR~U2656AA~1~IM~~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2998BA~1~IM~LL~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~0973~1~SC~~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0336047	12/24/2008	NY	24.0	24		F	12/19/2008	Patient fainted after receiving vaccines									Y	12/10/2008	12/10/2008	0		PVT	UNK	None	None	NKDA			1						1	Syncope	FLU3~SANOFI PASTEUR~U2803AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0650X~1~IM~RA~HPV (GARDASIL)~1|TDAP~SANOFI PASTEUR~0650X~1~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0336048	12/24/2008	NY	35.0	35		F	12/20/2008	Complains of wheezing advised to go to ER				Y					U	12/20/2008	12/20/2008	0		OTH	UNK	None	Complains of wheezing	None			1						1	Wheezing	FLU3~SANOFI PASTEUR~U2853AR3~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0336061	12/24/2008	TX	63.0	63		F	12/22/2008	Initial report received on 14 November 2008 from a health care professional. A 63 year-old female patient received on 20 October 2008 FLUZONE SV 2008-2009 (lot# U2765AA, Intramuscular into the left deltoid. Within 1 week she could not reach back to buckle the seat belt. No other symptoms were reported. No treatment was given. The patient saw her physician on 14 November 2008. The patient had no illness at vaccination time and had unspecified allergies. She received flu shot previously and no adverse event was reported. Follow-up information received on 11 December 2008 from a physician. At the time of vaccination on 20 October 2008, the patient had pre-existing medical history of very mild allergy to either chicken and/or egg and egg products that is continuing, as well as hypothyroidism, adrenal insufficiency, heart murmur and allergy to BACTRIM and Ampicillin. The patient also takes concomitant medication of XANAX (indication not provided). Other concomitant medications include, Armour thyroid (for hypothyroidism) and CORTEF (for adrenal insufficiency). The patient received the FLUZONE SV 2008-2009 vaccine on 20 October 2008 at 09:25 am. The expiration date for the vaccine was reported as 30 June 2009. A copy of a letter from the patient to the physician dated 12 November 2008 was provided. In that letter, the patient stated she called the physician several times over the past several weeks to give the nurse an update on the soreness in her arm after receiving the FLUZONE SV 2008-2009. The soreness, which was supposed to last a day or two, was still continuing on 12 November 2008, especially when the patient rotated her left arm, shoulder and upper arm in certain positions; and when she tries to buckle the seat belt in the care by her self when she is on the passenger side, of which she is unable to do. The patient denied any redness, swelling or tenderness to the left arm. The patient reported that last year and the year before she had been taken the flu shot with no problems and a pneumonia shot that caused soreness and aches, but within a week or so it was over. Prior to that, she had received either foreign measles or measles vaccine in her hip in her mid thirties and within a week her tail bone and coccyx area began to get sore and she had trouble sitting comfortably for the next two years requiring use of a plastic inflatable ring to sit. The patient had not taken any other vaccinations within 25 years prior to that. The patient expressed concern that she may have some sort of sensitivity to vaccines, but that was not confirmed by a physician. The patient was going to file a VAERS form. On 17 November 2008, the patient was evaluated by her physician for the soreness in the left arm and she reported that she had been self medicating with ibuprofen for this and had relief but the soreness continues. Physical examination that day revealed the patient's left upper arm with no redness or skin changes, and with mild left shoulder impingement, mild frozen shoulder and ned drop test. Neurovascular examination was ok. Final assessment was shoulder bursitis/tendonitis with stream of events as follows: flu shot leading to myalgia leading to tight shoulder leading to shoulder tendonitis/bursitis. The patient expressed desire for acupuncture but it was not reported whether this occurred or not. The patient was to return to the physician's office for evaluation as needed. At the time of this report, the patient has not recovered. Documents held by sender: Medical Records, doctor letter, copy of patient letter to physician dated 12 November 2008, immunization consent form dated 20 October 2008.				Y					N	10/20/2008			Per the reporter, N/A	PVT	PVT	Xanax; Armour thyroid; Cortef		Unspecified allergies. She received flu shot previously and no adverse event was reported. The patient did not have any concurrent illnesses at the time of vaccination on 20 October 2008. From new information received on 11 December 2008, it was reported that at the time of the vaccination on 20 October 2008, the patient had a pre-existing medical history of very mild allergy to either chicken and/or egg and egg products that is continuing, as well as hypothyroidism, adrenal insufficiency and a heart murmur. The patient is also allergic to BACTRIM and Ampicillin and takes additional concomitant medication of XANAX (indication not provided). The patient had received a pneumonia shot prior to two years ago and experienced soreness and aches, but within a week or so I was over.		200803626	1						1	Bursitis; Myalgia; Pain in extremity; Periarthritis; Rotator cuff syndrome; Tendonitis	FLU3~SANOFI PASTEUR~U2765A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0336069	12/24/2008	NM	1.9			F	12/17/2008	A serious spontaneous report of accidental exposure, possible encephalitis, and runny nose has been received from a Registered Nurse (the patient's mother) concerning a 23-month-old female. Medical history and concomitant medications were not reported. On 12-Nov-2008, the patient's father received FLUMIST. The patient did not receive FLUMIST. On 24-Nov-2008, the patient developed a runny nose that was off and on and lasted until 01-Dec-2008. On 04-Dec-2008, the patient began experiencing neurological difficulties. She developed ticks described as blinking, facial movements, shoulder movements down to her fingers, and toes twitching. She had sensitivity as light and bad fevers which were 101-102 degrees F with treatment with TYLENOL. She had cognitive and speech loss for 4-5 days where she was not able not able to speak like she normally did, she could not say apple which she could easily say previously and she would say what's that? to things that she previously knew. She was not eating, only wanted to nurse, was not sleeping and was irritable. She was not lethargic. The patient went to the pediatrician on 05-Dec-2008 and 10-Dec-2008. She was prescribed amoxicillin and the patient's mother was told only to give it to her if she got worse. The patient started getting better so she never received amoxicillin. On 17-Dec-2008, the patient was seen by a neurologist. The neurologist indicated it was possibly encephalitis but there was no way to know because the patient's symptoms were resolving. A brain magnetic resonance imaging (MRI) on 18-Dec-2008 was normal. There was no spinal tap or electroencephalography (EEG) done. As of 22-Dec-2008, the patient's symptoms resolved although she was still experiencing headaches and tiring easily. The patient's mother indicated that the neurologist reviewed the chronology of the events and indicated that it could have been from exposure to the father after receiving FLUMIST. The sponsor considered the event of possible encephalitis to be serious (important medical event). Follow-up: (1) Data not updated. (2) Called mother of patient and left voicemail requesting data. (3) Subject was accidentally exposed to vaccine.													MRI, 12/18/08, normal	MIL	OTH	Concomitant Drug (s) not reported				MEDI0007640	1						1	Accidental exposure; Aphasia; Cognitive disorder; Diet refusal; Dyskinesia; Excessive eye blinking; Fatigue; Headache; Inappropriate schedule of drug administration; Insomnia; Irritability; Movement disorder; Muscle twitching; Nervous system disorder; Nuclear magnetic resonance imaging brain normal; Nuclear magnetic resonance imaging normal; Photophobia; Pyrexia; Rhinorrhoea; Secondary transmission; Tic	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0336072	12/24/2008	NY	8.0	8		F	12/24/2008	AFTER RECEIEVING THE VACC FOR HEP A,FLU AND PPD ,PT SAYS SHE FELT PAIN IN HER EYES AND ALSO FELT DIZZY ,FELL STRAIGHT BACK  AND HIT HER HEAD AGAINST THE WALL,SAYS SHE REMEMBERS THE INCIDENCE,NO ITCHING,OR PROBLEM BREATHING,,WHEN EXAMINED ,SHE IS LYING ON THE BED STILL C/O PAIN THE EYES,PT NOTICED TO HAVE OBVIOUS CONJUNTIVAL INJECTIO,PT GIVEN BENEDRYL AND OXYGEN,SEND TO ER				Y					U	12/23/2008	12/23/2008	0		PUB	PUB						1						1	Conjunctival hyperaemia; Dizziness; Eye pain; Fall; Head injury	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89623~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB260AA~1~IM~RA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0336074	12/24/2008	MA	55.0	55		F	12/24/2008	Dizzyness, muddled thinking, somewhat confused.  Began when I woke up the day after around 6AM Wed,Dec 3th.  Called doctor, told me to wait it out, called the next day and went in to see him.  He did an EKG, my blood pressure was elevated (about 145 over 90), did a blood test, sent me downstairs for a chest X-Ray and a head CT. Each day after it got a bit better and I felt like my old self by Sunday, Dec. 7th.				Y					Y	12/02/2008	12/04/2008	2	Complete Blood count, TSH, EKG,  chest X-Ray and head CThead CT, all normal	PVT	UNK	Oxycontin 20mg 2xdaily, Neurontin 300mg 3xd, Flexeril 10mg, 3xd (Back surgery on November 5, 2008) Baclofen 20 mg 3xd, Amitriptyline 100mg 1@bed, Doxepin 75MG 1@bed, Pravachol 80mg 1@bed, Advil 800mg, 4xd, 1.2 grams fish oil 2xd, SleepMD 1@	Had back surgery on November 5, 2008	Allergic to all cillins, ceclors, ceftins,Augmentin, Lopid (anaphalactic reaction)			1						1	Blood pressure increased; Blood thyroid stimulating hormone; Chest X-ray normal; Computerised tomogram normal; Confusional state; Dizziness; Electrocardiogram normal; Full blood count normal	FLUX~UNKNOWN MANUFACTURER~Don't know~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0336075	12/24/2008	CA	1.58	1	.5	M	12/24/2008	LAST NIGHT RASH APPEARED CHEEKS AND EYELIDS FIRST THEN SPREAD TO CHEST AND BELLY.  iNCREASED FUSSINESS, DECREASED APPETITE NO FEVER, LAST WEEK RHINORRHEA, CLEARED UP AFTER 2 DAYS, NO VOMITING OR DIARRHEA, DECREASED ENERGY BUT NOT LETHARGIC, RUBBING EYES NO KNOWN EXPOSURE OTHER THAN IMMUNIZATION. NO CHANGE IN PERSONAL CARE PRODUCTS.										12/12/2008	12/24/2008	12	NONE	UNK	UNK	NONE	NONE	NONE			1						1	Asthenia; Decreased appetite; Irritability; Rash; Rhinorrhoea	DTAP~SANOFI PASTEUR~C2798AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2974BA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0916X~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1323X~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0336083	12/26/2008	CT	60.0	60		F	12/26/2008	Pt c/o being flushed and anxious.  BP 160/110 with pulse rate of 70.  Pt c/o heart palpitations.  Reasssessed by staff in 10 minutes, pt stated feeling better and returned to work`									Y	11/06/2008	11/06/2008	0	None	PUB	PUB	Kurlon, Cozaar	None	Hypertension			1						1	Anxiety; Blood pressure increased; Flushing; Heart rate normal; Palpitations	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89986~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0336101	12/26/2008	OH	7.0	7		F	12/19/2008	Next morning arm swollen, red and hard. Very tender.									Y	11/22/2008	11/23/2008	1		PVT	PVT	None	None	None			1						1	Erythema; Induration; Oedema peripheral; Tenderness	FLU3~PARKDALE PHARMACEUTICALS~U2770AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUOGEN)~1|VARCEL~MERCK & CO. INC.~119HX~2~UN~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0336109	12/26/2008	MO	10.0	10		M	12/19/2008	Patient was at check out with mom, told mom stomach hurt then had syncopal episode-aroused after 3-5 seconds then got up. No incontinence, no disorientation.									Y	12/12/2008	12/12/2008	0		PVT	OTH	None	C/O sore throat of an on since Sept	Cifalexin			1						1	Abdominal pain upper; Syncope	FLU3~SANOFI PASTEUR~U2829AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0351862	12/26/2008	LA	26.0	26		F	12/17/2008	Pt called health unit to report eyes red, cough/stopped up approximately starting one hour after vaccine administered. Instructed to report to E.R. now for evaluation									U	12/17/2008	12/17/2008	0		PUB	PUB	None	None			CA081206	1						3	Cough; Ocular hyperaemia; Cough; Ocular hyperaemia; Respiratory tract congestion	FLU3~SANOFI PASTEUR~U2848AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|TDAP~SANOFI PASTEUR~C3027AA~1~IM~LA~TDAP (ADACEL)~2|FLU3~SANOFI PASTEUR~U2848AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3|TDAP~SANOFI PASTEUR~C3027AA~1~IM~LA~TDAP (ADACEL)~3	USA		Influenza
0336093	12/28/2008	PA	31.0	32		M	12/28/2008	Persistant Arm pain with difficulty lifting arm and pain when grasping objects									Y	10/28/2008	10/28/2008	0	CK 268 nl	PVT	PVT		None				1						1	Blood creatine phosphokinase increased; Mobility decreased; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~u2788ea~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0336096	12/28/2008	GA	0.5	0	.5	F	12/28/2008	Received routine 6 month vaccinations on 10/3/2008 plus a flu shot (HepB, DTap, Rota, PCV, IPV, flu).  Had a cold or respiratory virus 2 days prior to receiving shots.  Patient ran a fever after receiving the shots and then consistently ran fevers for 6 days despite receiving tylenol alternating with motrin around the clock. By Sunday patient had a rash. at first looked like mosquito bites, then looked like flea bites as rash spread.  On Monday rash was all over patients body.  We took her to her pediatricians office who diagnosed her as having erythema multiforme. MD did not prescribe any meds at this time.  After trip to ER after patient would not sleep still no medicine prescribed.  on Thursday 10/9 we went back to pediatricians office and were given prescriptions for zantac and orapred.  After one dose of steroid rash disappeared				Y					Y	10/03/2008	10/05/2008	2		PVT	UNK	prevacid 7.5MG DAILY	Patient had a cold	none			1						1	Erythema multiforme; Pyrexia; Rash generalised; Sleep disorder	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~~3~IM~~DTAP + HEPB + IPV (PEDIARIX)~1|FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PNC~PFIZER\WYETH~~3~IM~~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0328640	12/29/2008		78.0	78		F	12/23/2008	This is in follow-up to report(s) previously submitted on 12/23/2008. Information has been received from a nurse practitioner concerning a 78 year old female patient with high cholesterol and osteopenia, no known drug or food allergies and no other adverse reactions to vaccines in past who on 08-OCT-2008 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# 662970/1207). Concomitant therapy included SIMVASTATIN (manufacturer unknown), alendronate sodium (MSD) and Calcium.  The patient also received FLUZONE (SANOFI, LOT # U2809AA) on 08-OCT-2008.  On 10-OCT-2008 the patient experienced red, itchy, pinpoint confluent rash on her thighs. The patient went into hot tub thinking it would improve rash.  On 11-OCT-2008 the patient also had the same nature rash on arms and back. The patient has been taken BENADRYL, Oatmeal Bath, and calamine lotion for treatment of rash.  There was no drainage and no other adverse effects noted.  At the time of this report, the adverse event was not improving, but not getting any worse since 11-OCT-2008.  The patient sought medical attention via returning to clinic.  No further information is available.				Y					N	10/08/2008	10/10/2008	2	Unknown	OTH	OTH	FOSAMAX;  Calcium (unspecified); SIMVASTATIN	Cholesterol high;  Osteopenia			WAES0810USA03080	1						2	Burning sensation; Rash; Erythema; Rash pruritic	FLU3~SANOFI PASTEUR~U2809AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~1207X~1~IM~LA~ZOSTER LIVE (ZOSTAVAX)~1|FLU3~SANOFI PASTEUR~U2809AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|VARZOS~MERCK & CO. INC.~1207X~UNK~UN~UN~ZOSTER LIVE (ZOSTAVAX)~2	USA	Emergency room visit	Influenza
0335969	12/29/2008	TX	24.0	24		M	11/28/2008	Patient with PMH of asthma and significantly elevated IgE 2159 was admitted with the right axilla pain after the PNEUMOVAX and the flu shot in the right arm yesterday earlier during the day. He was also given Td in left arm. Patient had exquisitely tender anterior aspect of right axilla when moving adducting and abducting the right shoulder. Patient was seen by the neurology, general surgery and orthopedic, and was also discussed with allergy immunology team. He was empirically given abx. pain meds and IVF MRI of the right shoulder was obtained that confirmed cluster of enhancing masses in the right axilla most consistent with lymph nodes with surrounding mild inflammation. No abscess, therefore it was believed that patient has had reactive lymphadenitis to the immunization (flu, PNEUMOVAX) that he received in the right arm on 11/25/08. Symptoms: 1. lymphadenitis, pain  1/27/2009 MR received for DOS 1/26-27/2008 with D/C DX:  Reactive Lymphadenitis of R axilla. Pt presented with excrutiating pain and swelling of R axillary lymph nodes which began 4-5 hrs after receiving vax. Low grade temp and tenderness upon movement of shoulder and palpation as well as some swelling and redness of R arm. Asthma exacerbation in ER which responded to nebs. Tx with abx, pain meds and IVF. To f/u as outpt.					Y	2				11/25/2008	11/26/2008	1	Labs and Diagnostics:  MRI (+) for a cluster of enhancing masses c/w lymph nodes with surrounding inflammation. WBCs 12.3.	UNK	UNK	albuterol HFA; fluticasone; Omalizumab; Omeprazole; Zolipidem tartrate		PMH: asthma, hx of smoking.			1						2	Blood immunoglobulin E increased; Lymphadenitis; Lymphadenopathy; Pain in extremity; Axillary pain; Inflammation; Injected limb mobility decreased; Lymphadenitis; Mass; Nuclear magnetic resonance imaging abnormal; Tenderness	FLU3~SANOFI PASTEUR~89297~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1287x~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~UNKNOWN MANUFACTURER~u23456~UNK~IM~LA~TETANUS DIPHTHERIA (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~89297~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~1287X~UNK~UN~RA~PNEUMO (NO BRAND NAME)~2|TD~UNKNOWN MANUFACTURER~~UNK~~LA~TD ADSORBED (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0336129	12/29/2008	MS	0.5	0	.5	F	12/22/2008	Death - Mom discovered infant's head wedged between pillow and bed Thursday morning. 1/2/09-autopsy report received-COD 1. Compressive asphyxia. Compressive markings of skin of chest, shoulders and sides of face. Pulmonary atelectasis. Dilated heart, hypoxic myocardium. Congested cyanotic brain and viscera. Petechiae in epicardium, pleurae and thymus glad. Aspiration of gastric contents. Bilateral enlarged renal pelves, stenotic ureteropelvic junctions, right more than left.	Y	12/17/2008							N	12/15/2008	12/17/2008	2	Autopsy - report showed accidental suffocation as COD.	PUB	PUB		Cough congestion	Reflux			1						1	Asphyxia; Autopsy; Death	DTAPIPVHIB~SANOFI PASTEUR~C3174AA~1~UN~LL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~U2797CA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1719U~2~UN~RL~HEP B (FOREIGN)~1|PNC~PFIZER\WYETH~C52997~3~UN~RL~PNEUMO (PREVNAR)~1	USA	Results in Death	Influenza
0336135	12/29/2008	LA	1.1	1	.1	M	12/23/2008	This case was reported by a physician and described the occurrence of fat atrophy in a 13-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline), ACTHIB. The subject's medical history included cleft lip, cleft lip repair and renal problems. Previous and/or concurrent vaccination included influenza virus vaccine; manufacturer unspecified; unknown given on 29 September 2008; PREVNAR (non-gsk); Wyeth Labs; unknown given on 29 September 2008. Concurrent medications included ENALAPRIL. On 29 September 2008 the subject received 4th dose of INFANRIX (.5 ml, unknown, right thigh), unspecified dose of ACTHIB (unknown, right thigh). On 29 September 2008, less than one day after vaccination with INFANRIX, at an unspecified time after vaccination with ACTHIB, the subject experienced fat atrophy, skin discoloration, skin indentation and pain. This case was assessed as medically serious by GSK. A physician reported that he gave a 13-month old subject his 4th dose of INFANRIX vaccine and the subject developed a small purple spot that enlarged and became pitted over the course of one month. There may have even some pain associated with the area, but the physician was not certain. The subject also received an ACTHIB vaccine in the same thigh and separate location that day. The physician is not certain if the site was of the INFANRIX or of the ACTHIB. At the time of the report, the area had not improved or worsened but currently appeared to be a discolored, indentured area where the subcutaneous fatty tissue had atrophied leaving muscle directly covered with thin parchment like skin. At the time of reporting the events were unresolved. The physician considered the events were possibly related to vaccination with INFANRIX and ACTHIB.				Y					N	09/29/2008	09/29/2008	0	UNK	PVT	PVT	Enalapril	Unknown	Cleft Lip; Cleft Lip repair; Renal problems		A0761372A	1						1	Lipoatrophy; Pain; Skin discolouration; Skin disorder	DTAP~GLAXOSMITHKLINE BIOLOGICALS~~4~UN~RL~DTAP (INFANRIX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~SANOFI PASTEUR~~UNK~UN~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~~UNK~UN~UN~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0336147	12/29/2008	CA	50.0	50		F	12/19/2008	About 15 seconds S/P FLUZONE 0.5ml IM;  Dyspnea, tongue swelling, tinnitus.  50 mg BENADRYL IM and 0.3 ml EPINEPHRINE SQ given - Transported stable condition to ER				Y					Y	12/15/2008	12/15/2008	0	Pt has Hx of anaphylactic reaction to:  Hair dye and CELEBREX	PVT	PVT	LEXAPRO	None	hair dye and CELEBREX (anaphylactic reaction)			1						1	Dyspnoea; Swollen tongue; Tinnitus	FLU3~SANOFI PASTEUR~U2789DA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0336150	12/29/2008	CO	9.0			F	12/18/2008	School RN contacted outreach clinic RN to let me know this patient's mother stated her daughter's TIV injection site had some oozing and was swollen up to 2 days after injection.  Patient was seen by her PCP, topical antibiotic cream given per mom, and was fine by next day.				Y					Y	12/10/2008	12/11/2008	1	None	PUB	PUB	Unknown	Unknown	Unknown			1						1	Injection site discharge; Injection site swelling	FLU3~SANOFI PASTEUR~U2828AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0336151	12/29/2008	CO	14.0	14		F	12/20/2008	5X4 cm area of redness on left upper arm									U	12/17/2008				PVT	PVT		Viral illness afebrile				1						1	Injection site erythema	FLU3~SANOFI PASTEUR~AHAVB320BA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~U2807AA~2~UN~LA~HEP A (HAVRIX)~1	USA		Influenza
0336152	12/29/2008	NH	13.0	13		F	12/22/2008	Within 24 hrs arm itchy and red-swollen-size of tennis ball.  2nd day redness and swelling doubled in size.  3rd day still red and swollen size - 15X16 cm at office.									U	12/19/2008	12/20/2008	1	None	PVT	PUB	None	Healthy	None			1						1	Erythema; Oedema peripheral; Pruritus	FLUN3~MEDIMMUNE VACCINES, INC.~500584P~4~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0063X~3~IM~RA~HPV (GARDASIL)~1|VARCEL~MERCK & CO. INC.~1012X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0336156	12/29/2008		15.0	15		M	12/12/2008	Nosebleed immediately after FLUMIST for 3-5 minutes, resolved spontaneously.									Y	11/14/2008	11/14/2008	0	None	MIL	MIL	None	None	None			1						1	Epistaxis; Immediate post-injection reaction	FLUN3~MEDIMMUNE VACCINES, INC.~500557P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0336158	12/29/2008	CA	37.0	37		M		Immediately after injection with fine rash to deltoid region, then 5 days later with bright red rash to ankles which was less in 2 days-non pruritic-8 days after injection with fine maculopapular rash to anterior deltoid/chest. No acute allergic event.				Y					Y	12/15/2008	12/20/2008	5	None	PVT	UNK	None	None				1						1	Immediate post-injection reaction; Rash; Rash erythematous; Rash maculo-papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0336159	12/29/2008	WV	43.0	43		M	12/22/2008	PNEUMOVAX given 12-18-08.  Patient became ill 2-20-08 with symptoms, fever, chills, sweating, cough, fatigue and weakness.  Office visit 12-22-08 CXR showed extensive left lower lobe Pneumonia treated in office 1000mg ROCEPHIN IM, nebulizer treatment and Rx's for AVELOX 400mg 8d and ROBITUSSIN AC after 4 hrs PRN.				Y					U	12/18/2008	12/20/2008	2	Chest X-Ray (+)  L.L.L. Pneumonia	PVT	PVT	ROBITUSSIN AC;  AVELOX;  ROCEPHIN;  ACCUPRIL;  SPIRONOLACTONE;  METOPROLOL;  COZAAR;  CPAP;  LANTUS INSULIN;  KLOR CON;  HUMALOG;  AMLODIPINE;  LOVASTATIN		DM Insulin Requiring, HTN, Sleep Apnea, Hyperaldosteronism, Chronic Hypokalemia			1						1	Asthenia; Chest X-ray abnormal; Chills; Cough; Fatigue; Hyperhidrosis; Lobar pneumonia; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~90000~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1161X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0336160	12/29/2008	OH	38.0	38		M	12/22/2008	Red ring of elevation, itchy and very sore									Y	12/18/2008	12/19/2008	1		PVT	PVT			Sulfa, PCN			1						1	Erythema; Pain; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89619~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1163X~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0336162	12/29/2008	CO	47.0			F	12/16/2008	General low energy, rash on front of body, pain in throat/mouth.  Sudden symptoms, muscle pain.									Y					PVT	PVT		None	None			1						1	Asthenia; Myalgia; Oral pain; Oropharyngeal pain; Rash	FLU3~SANOFI PASTEUR~U2755AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336164	12/29/2008	MD	16.0	16		F	12/17/2008	Patient given FLUMIST and GARDASIL and subsequently noted urine HCG was positive.									U	12/17/2008			Urine HCG	UNK	UNK		None	None			1						1	Drug exposure during pregnancy; Urine human chorionic gonadotropin positive	FLUN3~MEDIMMUNE VACCINES, INC.~500558P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~1740U~UNK~UN~UN~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2818AA~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0336167	12/29/2008	CA	2.0	2	.1	F	12/03/2008	Right thigh swelling, redness, warm to touch.  Reminded mother to rub area every 2 hrs. and apply ice pack first 24 hours then warm compress.  Call PRN if increased redness & swelling.									U	12/01/2008	12/01/2008	0	None	PVT	OTH	Unknown	Unknown	Unknown			1						1	Injection site erythema; Injection site swelling; Injection site warmth	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B087CA~3~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2788FA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1258U~1~IM~LL~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~A09962~3~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0281U~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1321X~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0336168	12/29/2008	CA	57.0	57		F	10/14/2008	Started 2000 10/07/08. Severe pain in joints, chills, fever 101 degrees. Took EXCEDRIN for H/A, SOB, took nebulizer 3xs in less than 12hrs. General malaise.									Y	10/07/2008	10/07/2008	0		PUB	UNK	FORTEO SQ injections daily	None	SUDAFED; osteoporosis; asthma			1						1	Arthralgia; Chills; Dyspnoea; Headache; Malaise; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0336169	12/29/2008	CA	50.0	50		F	11/07/2008	On 11/7/08 around 9:00am patient leaned against doorway and felt pain in right upper arm. Patient felt the area warm and observed that it was red. Erythema measures 45 cm by 25cm, feels warm and swollen. Patient states It's feeling less sore and warm.									Y	11/06/2008	11/07/2008	1		PUB	PUB	THYROID; CYMBALTA; WELLBUTRIN; PALMAR	None	AMOXICILLIN			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2765AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336170	12/29/2008	CA	7.0	7		M	12/22/2008	Fever within 24hrs, up to 103.7.									Y	12/05/2008	12/05/2008	0	None	PVT	UNK		None				1						1	Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500585P~4~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0336172	12/29/2008	MT	28.0	28		M	12/23/2008	4th year getting FLUMIST and patient states this has happened every year, sore start to develop in both nostrils and then scab over. They bleed when nose is blown. Pain scale 0-10 (10 being highest) , patient rates at a 6-7. They last for 2/1/2 months and are painful the entire time.									Y	10/15/2008	10/22/2008	7		PVT	PVT						1						1	Epistaxis; Rhinalgia; Scab	FLUN3~MEDIMMUNE VACCINES, INC.~500543P~4~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0336181	12/29/2008	CT	54.0			F	12/29/2008	This case was reported by a physician and described the occurrence of influenza in a 54-year-old female subject who was vaccinated with Influenza vaccine, manufacturer unspecified. In October 2008, the subject received a dose of Influenza vaccine (unknown). In 2008, at an unspecified time after vaccination with Influenza vaccine, the subject experienced influenza and vaccination failure. A physician reported that his wife, the subject, received a flu vaccine from an unknown manufacturer approximately two months ago, in October 2008. On 24 December 2008, the physician inquired about using RELENZA in the subject and noted the subject was immunized and still got the flu. The physician did say that the subject's throat was swabbed and it was identified as a B strain. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were unspecified.									U	10/01/2008			UNK	PUB	PUB		Unknown	No concomitant medications or relevant medical history. It was unknown if the subject had previously received INFLUENZA vaccinations.		A0761732A	1						1	Influenza; Influenza serology positive; Vaccination failure	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0336196	12/29/2008	CA	23.0	23		M	12/29/2008	pt rec'd a flu shot at his job.  the next day he felt very ill. He was noted to have a diffuse rash on posterior palate with individual white vesicles/comedones on erythematous bases.									U	11/08/2008			sores grew out HSV+, serum antibody levels for HSV at the time were negative, suggesting a new infection, without development of antibodies.	UNK	UNK						1						1	Antibody test negative; Blister; Herpes simplex; Malaise; Oral mucosal eruption; Rash; Rash erythematous	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0336204	12/29/2008	MN	65.0	65		M	12/29/2008	Left facial droop 1 week after recieving flu vaccine										12/19/2008	12/25/2008	6		PVT	PVT	BACLOFEN, ASPIRIN, METFORMIN, CADUET, TOPROL, PRINZIDE, PREVACID,	NO	HYPERTENSION, DIABETES, MELANOMA,HPERLIPIDEMIA, HICCUPS X 2 WEEKS			1						1	Facial palsy	FLU3~SANOFI PASTEUR~U2761AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336210	12/29/2008	DC	20.0	20		M	12/29/2008	RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE									U	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336211	12/29/2008	DC	43.0	43		M	12/29/2008	RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE									U	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336212	12/29/2008	DC	33.0	32		M	12/29/2008	RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE									U	11/16/2008			RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE	MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336213	12/29/2008	DC	20.0	20		M	12/29/2008	RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE									U	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336214	12/29/2008	DC	36.0	36		M	12/29/2008	RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE									U	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336215	12/29/2008	DC	19.0	19		M	12/29/2008	RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE									U	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336216	12/29/2008	DC	20.0	20		M	12/29/2008	RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE									U	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336217	12/29/2008	DC	25.0	25		M	12/29/2008	RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE									U	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336218	12/29/2008	DC	46.0	46		M	12/29/2008	RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE									U	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336220	12/29/2008	DC	46.0	45		M	12/29/2008	RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE									U	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336221	12/29/2008	DC	23.0	23		M	12/29/2008	RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE									U	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336222	12/29/2008	DC	53.0	53		M	12/29/2008	RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE									U	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336230	12/29/2008	CA	53.0	53		M	12/29/2008	Patient had grand mal seizure(1st ever)within few hours of receiving vaccines.				Y					Y	12/17/2008	12/17/2008	0	CT of head, left frontal, lobe density from old trauma; CHEM 20, CBC, all normal	PVT	PVT	ALLOPURINOC; Oxycodone; COLCHICINE; DICMAZEM; LYRICA; ASA	Gout; Peripherne  neuropathy	H/O distant head trauma			1						1	Full blood count normal; Grand mal convulsion; Laboratory test normal; Scan brain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8811004~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1163X1~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0337001	12/29/2008	WI	76.0	76		F	12/23/2008	Information has been received from a registered pharmacist and female consumer concerning a 76 year old female patient with high cholesterol, hypertension and allergy to CODEINE who on 06-NOV-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 663195/1416X).  Concomitant therapy unspecified medications for cholesterol and blood pressure lowering.  It was noted that the patient was possibly given the influenza virus vaccine (unspecified) on 06-NOV-2008.  The pharmacist reported that the patient developed a lump at the injection site.  The patient's daughter also called the pharmacist and feel it that the patient received the dose of ZOSTAVAX (Merck) intramuscularly because of the injection site reaction.  The pharmacist could not confirm that the dose of ZOSTAVAX was given intramuscularly.  The patient sought unspecific medical attention by calling the pharmacy.  Additional information has been requested.									U	11/06/2008	11/06/2008	0	None	OTH	OTH	Therapy unspecified	Cholesterol high; Hypertension; Drug hypersensitivity			WAES0811USA01341	1						1	Incorrect route of drug administration; Injection site mass	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~1416X~UNK~UN~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0337214	12/29/2008	OR				U	12/23/2008	Information has been received from a physician concerning a patient who was vaccinated with ZOSTER (Oka/Merck) (lot # not provided).  Secondary suspect therapy included influenza virus vaccine (unspecified).  Subsequently the patient experienced unspecified adverse event.  At the time of the report, on 05-NOV-2008, the outcome of the patient was unknown.  Additional information has been requested.									U				Unknown	OTH	OTH	Unknown		Unknown		WAES0811USA00591	1						1	Adverse event	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~UN~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0337226	12/29/2008	TN	67.0			F	12/23/2008	Information has been received from a physician concerning a 67 year old female with a history of sjogren syndrome who on 06-Oct-2008 was vaccinated with influenza vaccine in the left arm. On 07-Oct-2008 was vaccinated with a dose of ZOSTERVAX (lot#659408/0300X) under the right arm 1 finger away from the arm pit. Within hours after of the vaccination, the patient experienced a large injection site reaction consisting of warmth, in duration, pain, extending from the elbow to the breast and chest, along with systemic symptoms including fever, malaise and severe headache. The vaccine had been administered at a clinic from a single vial with a physician's prescription. The patient experienced 1/2 dollar size pink spot within 30 minutes of receiving vaccine which over the next several days continued to spread down the arm to the elbow and across the chest. No rash but involved area was very swollen, red warm to touch, painful and was also described hard as a rock. The area on the arm and chest then broke up after about a week into smaller knots. The patient also described a sore knot developed across her right shoulder blade approximately quarter size which lasted about a week. Patient was in bed one week with extreme headache, fever of 100.5, malaise with the injection site, arm and chest inflammation. The patient called physician because she thought she had the flu and was not seen by physician but prescribed Z-PAC on 22-Oct-2008. The patient felt better by 25-Oct-2008. On 30-Oct-2008, the patient had blood work but the patient was not sure why or what type of blood work was being collected and would be contacted by a physician next week. Currently injection site was red, pinkish blue 2 inches by one inch in size with no pain. The patient questioned whether the vaccine was kept adequately frozen since the patient and her husband heard it had been transported from another pharmacy 40 minutes away and also there was a delay of about a half hour from the time they where told that the vaccine was being prepared till the actual receipt of the injection. The clinic clarified that the vaccine was stored transported from another pharmacy off site in a cooler with ice packs. The clinic also mention that the company was contacted and mentioned that a lot check was done on the vaccine lot and found no problems in their data. This is one of several reports received from the same source. Additional information has been requested.									N	10/07/2008	10/07/2008	0	Unknown	OTH	OTH			Sjogren's syndrome		WAES0810USA05395	1						1	Activities of daily living impaired; Headache; Injection site erythema; Injection site induration; Injection site inflammation; Injection site pain; Injection site reaction; Injection site warmth; Malaise; Musculoskeletal pain; Pyrexia; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~659408/0300X~UNK~UN~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0337274	12/29/2008	CO	70.0	70		F	12/23/2008	Information has been received from a pharmacist concerning a 70 year old female who on 11-OCT-2008 was vaccinated with one dose of ZOSTAVAX (Merck) (lot# 662971/1213) SQ.  Subsequently the patient developed a local reaction at the injection site.  The area was red and swollen about the size of 1 1/2 bandaids.  The patient was seen for follow up and it was reported that the reaction was resolving.  Follow-up information has been received from a pharmacist concerning a 70 year old female with allergy to ALENDRONATE NA (MSD, WAES 0811USA02064) who on 11-OCT-2008 was vaccinated with ZOSTAVAX (Merck) (lot# 662971/1213X) SQ into the left arm.  Concomitant therapy included influenza virus vaccine (unspecified).  On 11-OCT-2008 the patient experienced redness and swelling in injection site.  The patient's redness and swelling in injection site were slowly resolving.  The injection site was warm and still resolving on 03-NOV-2008.  Additional information is not expected.				Y					N	10/11/2008	10/11/2008	0	Unknown	PUB	OTH		Drug hypersensitivity			WAES0810USA02704	1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~1213X~1~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0337536	12/29/2008	NC	4.0			F	11/06/2008	A non-serious, spontaneous report of received FLUMIST in a single nostril in a four-year old female patient was received from a nurse. No medical history or concomitant medications were reported. FLUMIST was administered in one nostril; second half of the dose (0.1 ml) was also given in the same nostril. The patient wiped her nose after the dose was given. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.									Y					PVT	OTH	Concomitant Drug (s) Not reported				MEDI0007456	1						1	Medication error; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~5000561P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0335747	12/30/2008	PA	18.0	18		M	12/24/2008	Initial information was received on 17 December 2008 from a health care professional. An 18 year old male patient with a history of pneumonia (01 December 2008) treated with CIPRO, received an injection of FLUZONE SV 2008-2009 (lot number U2853AB) intramusculary in the deltoid on 15 December 2008 at 12:30 PM. On 15 December 2008, at 5:00 PM the patient became dizzy, was stumbling and had trouble walking. At 5:30 PM felt eyes rolling to back of his head and were fluttering for 5 minutes. He felt extreme malaise and fell asleep. The next morning he felt fine. The patient's parent reported that the patient had a seizure. The patient recovered. No further information was provided. Documents held by sender: None.				Y					Y	12/15/2008	12/15/2008	0	Not reported.	OTH	OTH			No known allergies. The patient recovered from pneumonia on 01 December 2008 and was treated with CIPRO.		200804027	1						2	Dizziness; Gait disturbance; Gaze palsy; Malaise; Convulsion; Dizziness; Gait disturbance; Gaze palsy; Malaise	FLU3~SANOFI PASTEUR~U2853AB~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2853A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0335993	12/30/2008	CA	11.0	11		M	12/24/2008	An 12 year old male patient with a history of allergic rhinitis received an intramuscular injection of FLUZONE SV 2008-2009 (lot number U2808AA) in the left thigh, MENACTRA (lot number U20808AA) in the left thigh, and BOOSTRIX (lot number AC52B028AA) in the right thigh on 3 November 2008. On 17 December 2008 the patient presented to the doctor's office with complaints of bilateral weakness in the upper and lower extremities. The patient was diagnosed with possible GBS (GUILLAIN BARRE syndrome) and was sent to the hospital. The patient was not recovered at the time of the report. Documents held by sender: none.					Y	0			N	11/03/2008	12/17/2008	44	None reported	PVT	PVT	FLONASE; LORATADINE		Patient had allergic rhinitis and had allergy tests.		200804029	1						2	Muscular weakness; Guillain-Barre syndrome; Muscular weakness	FLU3~SANOFI PASTEUR~U2008AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2662AA~UNK~IM~LL~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC525028AA~UNK~IM~RL~TDAP (BOOSTRIX)~1|FLU3~SANOFI PASTEUR~U2808A~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|MNQ~SANOFI PASTEUR~U2662A~UNK~IM~LL~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B028AA~UNK~IM~RL~TDAP (BOOSTRIX)~2	USA	Hospitalisation	Influenza
0336263	12/30/2008	IL	56.0	56		F	11/11/2008	Local swelling/redness/induration (extensive) started < 24 degrees after vaccine R deltoid area.				Y					Y	11/10/2008	11/10/2008	0	None	PVT	UNK	CITALOPRAM 4oz;  ADVAIR;  AVAPRO 300mg		Asthma;  Hypertension;  Anxiety			1						1	Erythema; Induration; Local reaction; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFUA138AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0814X~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0336265	12/30/2008	MI	2.0	2	.3	F	12/19/2008	On patient's body the evening of the influenza vaccination she developed a fever and on the following day she developed hives on her arms, legs and stomach.									U	12/17/2008				PVT	UNK	None	None	None			1						1	Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0336268	12/30/2008	NC	11.0	11		M	12/01/2008	Local erythema, color and pruritus symptoms induration.  Both arms-  No Rx									Y	01/24/2008	11/25/2008	306	None	PVT	PVT	None	None	None			1						1	Erythema; Induration; Local reaction; Pruritus	FLUN3~MEDIMMUNE VACCINES, INC.~500561P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB257AA~1~IM~RA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2727AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B029AA~UNK~IM~LA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1278X~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0336269	12/30/2008	CA	50.0	50		F	12/22/2008	Onset of pain R arm evening of shot - worsened with decreased range of motion and c/o pain down arm and shoulder area, front and back over the next two weeks.  Also experienced loss of balance several times and some nausea.   Office referred her to her doctor 12/9/08.  Per MD - possible cellulitis treated with BACTRIM DS and TYLENOL.  Improving as of 12/17 and 12/19/08.				Y					U	11/19/2008	11/19/2008	0		PUB	PUB	None	No	Sinus problems only			1						1	Balance disorder; Joint range of motion decreased; Musculoskeletal pain; Nausea; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0336281	12/30/2008	OH	38.0	39		M	12/30/2008	complains of persistent left arm pain at rest since receiving vaccine 12/10/2008. doesnt affect his arm during exertion but aches at night									U	12/10/2008	12/12/2008	2		UNK	PVT		none				1						1	Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89968~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0336284	12/30/2008	OH	76.0	76		M	12/30/2008	Large contusion below site of injection; noted 2 days after administration.									Y	12/22/2008	12/24/2008	2		PUB	UNK	Baby Aspirin twice weekly	healthy	history of prostate cancer 3-4 years ago			1						1	Contusion	FLU3~SANOFI PASTEUR~U2811AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336285	12/30/2008	PA	0.58	0	.6	M	12/30/2008	Mother of infant reported that infant had a low grade fever on 10/24 with a spike to 105 degrees Fahrenheit on 10/25, slight clear rhinorrhea. Tylenol every 4 hours decreased fever to 100 degrees Fahrenheit through 10/27. No fever after second dose of influenza vaccine 11/24/08.									Y	10/21/2008	10/24/2008	3	none	PUB	PUB	Ranitidine Hydrochloride 15 milligrams orally twice daily since 04/22/2008	none	Gastroesophageal reflux diagnosed at 1 month of age			1						1	Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~UT2782EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336289	12/30/2008	SD	0.58	0	.6	M	12/30/2008	Mother of infant reported that infant had a low grade fever on 10/24/2008 with a spike to 105 degrees Fahrenheit on 10/25/2008, slight clear rhinorrhea. Tylenol every 4 hours decreased fever to 100 degrees Fahrenheit through 10/27/2008. No fever after second dose of influenza vaccine on 11/24/2008.									Y	10/21/2008	10/24/2008	3	none	PUB	PUB	Ranitidine Hydrochloride 15 milligrams orally twice daily since 1 month of age	none	Gastroesophageal reflux diagnosed at 1 month of age			1						1	Pyrexia; Rhinorrhoea	FLU3~SANOFI PASTEUR~UT2782EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336294	12/30/2008	CA	17.0	17		F	12/30/2008	10 days after Varivax pt developed generalized pruritic rash of clear vesicles and erythematous papules which progressed to open lesions. Treatment was symptomatic only w/ topical Calamine lotion, Aveeno baths, and oral Benadryl.									U	12/12/2008	12/20/2008	8	varicella IgG neg. IgM pending.	PVT	PVT	Zovia, ranitidine, Trazodone	abdominal pain				1						1	Blister; Erythema; Rash papular; Rash pruritic; Skin lesion; Varicella zoster serology negative	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~2~IM~LA~HEP A (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~2~IM~RA~HPV (GARDASIL)~1|MEN~SANOFI PASTEUR~~1~IM~LA~MENINGOCOCCAL (MENOMUNE)~1|VARCEL~MERCK & CO. INC.~~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0336300	12/30/2008					F	12/30/2008	We received the following information on 21 OCT 2008: A patient experienced an adverse reaction after vaccination with FLUVIRIN. No more information is available. Addendum: We received additional information via a company member on 15 DEC 2008: A female (no further information) was vaccinated with FLUVIRIN (batch no. unknown) during a flu clinic on 09 OCT 2008. Five minutes after the vaccination (while shopping) both arms of the patient turned red and her blood pressure increased. She was transported to a hospital. No further information was provided.					Y	0			U	10/09/2008	10/09/2008	0		OTH	OTH	No other medications	Unknown			MA20082505	1						1	Blood pressure increased; Erythema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0336301	12/30/2008	WI	47.0	47		M	12/30/2008	12-10-08 approx 10 pm pain R shoulder, fever up to 104. Pain, redness and swelling increased during next 4 days. 12-14-08 Admitted to hosp from IC. Fever, headache, photophobia, nuchal rigidity. R deltoid area red warm, tender. Treated with IV fluids, warm compress, NSAIDS. D/C 12/16/08 no follow-up.   1/7/09 MR received for DOS 12/14-16/2008 with D/C DX: Adverse reaction to pneumococcal vaccine.  Aseptic Meningitis.  Local Reaction at site of injection. Pt presented to ER with fever of 104.9'F, progressive shoulder pain and frontal H/A x 3 days since receiving pneumonia vax.  ROS (+) for fever, chills, malaise, fatigue, diaphoresis, H/A, photophobia, eye pain and redness, cough, nausea & diarrhea, neck pain, dizziness, tingling. PE (+) for bilateral injected conjunctiva, photophobia, limited ROM of the neck, wheezing and crackles R lung, erythema R deltoid, dilated veins of R chest. Initially tx with abx which were d/c with CSF results.  Improvement noted with IVF and NSAIDS.				Y	Y	2			Y	12/10/2008	12/10/2008	0	12/14/08: Lumbar puncture - 24 RBC's, Glu 70, Protein 47; Blood cultures & CSF cultures neg; 12/16/08 Sinus xray-neg . Labs and Diagnostics:  WBCs 14.9.  79% neutros, 13% lymphs. Blood cx (-). CSF protein 47. CSF cell count 5- (97% lymphs, 3% macrophages). CSF cx (-).	PVT	PVT		COPD vs URI or asthma	Allergies: PCN, CIPRO, Bee sting (anaphylaxis). Medical conditions: Hypertension. PMH:  Allergy to PCN, Bees, Cipro.  MV collision.  H. pylori, smoker, temper, anal fistula, alcohol abuse, essential HTN			1						1	Blood culture negative; CSF culture negative; CSF glucose normal; CSF protein increased; Erythema; Headache; Lumbar puncture abnormal; Musculoskeletal pain; Nuchal rigidity; Pain; Photophobia; Pyrexia; Red blood cells CSF positive; Skin warm; Swelling; Tenderness; X-ray normal	FLU3~SANOFI PASTEUR~U2749AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0980X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0336302	12/30/2008	WI	55.0	55		M	12/30/2008	Pt reported side effects approx. 12/23/2008 at 5:00pm of severe headache, vision changes, pain and swelling in left arm.  Pt said pin then radiated throughout body.  Pt reports used TYLENOL for pain.  Pt reports sxs improved on 12/26/08									Y	12/23/2008	12/23/2008	0	None	PVT	PVT		Joint pain	Thyrotoxicosis;  obesity; hyperlipedemia			1						1	Headache; Pain in extremity; Swelling; Visual impairment	FLU3~SANOFI PASTEUR~U2744AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0980X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0336306	12/30/2008	IL	2.0	2	.1	F	12/30/2008	Experienced diarrhea for one week after receiving FLUMIST.				Y					Y	12/23/2008	12/23/2008	0	None	PVT	PVT	None	None	None			1						1	Diarrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0336310	12/30/2008	FL	2.0	2	.1	F	12/29/2008	Rash- erythema multiform onset within 24 hrs of administration.				Y					Y	11/07/2008	11/08/2008	1		PVT	UNK		Resolving om -just finished OMNICEF				1						1	Erythema multiforme; Rash	FLU3~SANOFI PASTEUR~UT2783DA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0332002	12/31/2008	TX	53.0	53		F	12/31/2008	Flu shot was given to me on September 30th, 2008 at the hospital. I am employed at this location as an administrative assistant in the Infection Control Department. Immediately, my left arm felt horrible, but I assumed the pain would go away. It has been three months and I am still in pain. Whenever I reach to my side to put on my seatbelt, I get a sharp pain. Hooking a bra or unhooking a bra is very painful for me. Any movement of my left arm brings horrible pain: pulling a T-shirt over my head, raising my arm the slightest, rolling on my left side to get in or out of bed. None of this pain occurred before the immunization was given. I filed a worker's comp claim with employee health and I have also visited my personal physician twice. After three months, the pain gets worse. My arm throbs continually, even  when not in use. I was advised by employee health to use wet heat on the area where the shot was administered. This gives me zero relief. Personal physician thinks nurse gave me the shot too high up on my arm and possible hit a bone or something else.				Y					N	09/30/2008	09/30/2008	0		UNK	UNK	none	none	none			1						2	Pain in extremity; Immediate post-injection reaction; Pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8803905~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0336323	12/31/2008	MD	35.0	35		F	12/22/2008	7 cm X 5 cm induration, tender LN to axilla to RVE				Y					Y	12/16/2008	12/19/2008	3		MIL	MIL	Albuterol Sulfate		Asthma			1						1	Induration; Lymph node pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA297AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|MMR~MERCK & CO. INC.~0453X~UNK~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TDAP~SANOFI PASTEUR~C2996AA~UNK~IM~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0336324	12/31/2008	PA	32.0	32		M	12/24/2008	vaccines given 12/9/2008.  High fever 12/10/08 with myalgia.  Fever again 12/16-12/18.  Body rash 12/20/08. Went to PCP and ER.				Y					Y	12/09/2008	12/10/2008	1		OTH	PVT	No	None	Confirmed Hep B virus as teenager			1						1	Myalgia; Pyrexia; Rash generalised	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA386AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|MMR~MERCK & CO. INC.~0238X~UNK~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TDAP~SANOFI PASTEUR~UF452AA~UNK~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0336329	12/31/2008	PR	45.0			M		Lipomas, skin fungus, skin allergies, muscle aches, back pain, numbness or tingling in hands or feet, difficulty remember, ringing of the ears, still feeling tired after sleeping, headaches, anxiety, depression,									U					UNK	UNK						1						1	Anxiety; Back pain; Depression; Dermatitis allergic; Fatigue; Fungal skin infection; Headache; Hypoaesthesia; Lipoma; Memory impairment; Myalgia; Paraesthesia; Tinnitus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA063AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|TDAP~SANOFI PASTEUR~~UNK~UN~UN~TDAP (ADACEL)~1	USA		Influenza
0336331	12/31/2008	IL	0.7	0	.7	F	12/31/2008	Aunt called office, informed RN pt. had fever, fussy, purple spots over entire body, swollen feet, not taking formula well. Sent to closest ER for evaluation. Non thrombocytopenic purpura.  2/2/09-records received for DOS 12/30/08-1/1/09-DC DX: Hematuria, edema, nonthrombocytopenic purpura. Presented with swelling of feet and knees, rash on legs and face, hematuria and non-thrombocytopenic purpura all looking like a vasculitic syndrome. Rash.				Y	Y	2			U	12/29/2008	12/30/2008	1	Possible HSP;Hematuria; Nl Platelets. See attached report. 2/2/09-records received-CBC, CMP, BUN, creatinine normal.urine and blood cultures negative. Antibody screen negative.	PVT	PUB		None	None			1						1	Haematuria; Hypophagia; Irritability; Oedema peripheral; Platelet count normal; Purpura non-thrombocytopenic; Pyrexia; Skin discolouration	FLU3~SANOFI PASTEUR~UT2792DA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0336334	12/31/2008	IA	43.0	43		M	12/31/2008	Next day. facial swelling, Lf. side facial swelling, head congestion, blurred , double vision, dizziness. Took OTC meds. Seen by VA 23rd. Placed on Amox, decongestants, warm clothes. Improved. Still has some blurred vision.				Y					U	12/16/2008	12/17/2008	1	None	MIL	MIL	None	None	Cough/Wheeze since March 2004 - No Diagnosis of Asthma.			1						1	Diplopia; Dizziness; Sinus congestion; Swelling face; Vision blurred	FLUN3~MEDIMMUNE VACCINES, INC.~500567P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0336336	12/31/2008	WI	2.0	2	.0	M	12/31/2008	6 hours after receiving FLU shot developed 101 degrees fever.  Mom did not check body, but in the morning noticed child developed hives over body.  BENADRYL was given, no respiratory problems.									Y	12/30/2008	12/30/2008	0	None	PVT	UNK		No	No			1						1	Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U2765AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336342	12/31/2008	CA	45.0	45		M	12/31/2008	generalized arthralgia, swelling of hands. patient received prednisone for treatment				Y					U	11/13/2008	12/15/2008	32	ANA and RA screens negative. CBC normal, CRP 3.1, ESR 47	PVT	PVT	Niaspan	none	hyperlipidemia, arachnoid cyst			1						1	Antinuclear antibody negative; Arthralgia; C-reactive protein increased; Full blood count normal; Oedema peripheral; Red blood cell sedimentation rate increased; Rheumatoid factor negative	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA174AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~055U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0330598	01/02/2009		43.0			M	12/30/2008	This case was received on 17 December 2008 via a search of the VAERS database (reference number 330598). It was originally reported to VAERS by another manufacturer. A 43-year-old male patient received the following vaccinations on 07 October 2008: smallpox (ACAM2000, lot not reported), TYPHIM VI, lot not reported), BIOTHRAX (lot not reported), FLUMIST (lot not reported), and ENGERIX (lot not reported) and six days later (also reported as 17 October 2008), he developed acute onset of substernal chest pressure at rest. The pressure became a sharp pain that worsened with deep breathing and also radiated down the left arm. According to the reporter, the patient's symptoms and EKG findings were most consistent with mild pericarditis and a viral syndrome, most likely as a result of the smallpox vaccine. An echocardiogram was to be performed to assess for a pericardial effusion and to ensure cardiac function was normal. The patient recovered from the event. Documents held by sender: None									Y	10/07/2008	10/13/2008	6	EKG-abnormal: most C/W (consistent with) mild pericarditis and a viral syndrome. Echocardiogram-results not reported.	UNK	UNK			Not reported		200804023	1						3	Chest pain; Echocardiogram; Electrocardiogram abnormal; Pain in extremity; Pericarditis; Viral infection	ANTH~UNKNOWN MANUFACTURER~~UNK~UN~UN~ANTHRAX (NO BRAND NAME)~3|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~3|SMALL~EMERGENT BIOSOLUTIONS~ACAM2000~UNK~ID~UN~SMALLPOX (ACAM2000)~3|TYP~SANOFI PASTEUR~~UNK~UN~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~3	USA		Influenza
0336385	01/02/2009	IL	0.5	0	.5	F	01/02/2009	Approximately 8 hours after receiving vaccines child spiked fever of 104 degrees(rectal) with vomiting and diarrhea. Twin sister had fever spike as well without the vomiting and diarrhea. Mother took both children to urgent care and was told by the attending physician that is was likely caused by the flu vaccine.  Child was treated with alternating tylenol and motrin with resolution three days later.				Y					Y	11/25/2008	11/26/2008	1		PUB	PUB	none	None.   Information in #14 entered in error.  No vaccinations given within 4 weeks of the date listed in #10 but unable to delete.	none			1						1	Diarrhoea; Pyrexia; Vomiting	DTAPIPVHIB~SANOFI PASTEUR~C3178AB~1~IM~LL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~UT2787DA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0062X~3~IM~LL~HEP B (RECOMBIVAX HB)~1|PNC~PFIZER\WYETH~C40031~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0336386	01/02/2009	IL	0.5	0	.5	F	01/02/2009	Received vaccines along with twin sister and spiked a fever of 103 degrees (rectal) within 8 hours after administration.  She wasn't having the vomitting and diarrhea that her sister was experiencing but she was also seen by physician at urgent care.  Attending physician told parents that it was from the flu vaccine. Continued with what mother describes as low grade fever for approximately three days.				Y					Y	11/25/2008	11/26/2008	1		PUB	PUB	None	None	NOne			1						1	Pyrexia	DTPPHIB~UNKNOWN MANUFACTURER~C3178AB~1~IM~LL~DTP + IPV + ACT-HIB (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~UT2787DA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0062X~3~IM~LL~HEP B (RECOMBIVAX HB)~1|PNC~PFIZER\WYETH~C40031~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0336391	01/02/2009	FL	53.0	53		F	01/02/2009	Beginning 12/11/08 Pt reports bumps on the back of hands bilaterally approx 1cm in diameter that spread all over body.  Pt repots the bumps are very itchy.  Pt was seen by GYN due to irritation in vaginal area and used Monistat cream twice without success.  Patient's GYN prescribed prednisone and a vaginal cream, which will start today.									N	12/10/2008	12/11/2008	1		UNK	PVT	Prilosec, multi-vit	None				1						1	Pruritus; Rash; Vulvovaginal discomfort	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflla166aa~4~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0336394	01/02/2009	MT	2.0	1	.9	M	01/02/2009	None									U	01/02/2009			None	PUB	UNK	none	none	none	none~ ()~NULL~~In Patient		1						1	Wrong drug administered	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~~UNK~~~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0336416	01/02/2009	OH	1.5	1	.5	M	12/23/2008	Seizure lasting 1-5minutes.  Fever 104+.  Final Diagnosis:  Febrile Convulsions. Additional: Acute Suppurative OM w/o ruptured eardrum.  Treatments: TYLENOL & AMOXICILLIN.				Y					Y	12/08/2008	12/18/2008	10		PVT	PUB			Febrile Seizure			1						1	Condition aggravated; Convulsion; Febrile convulsion; Otitis media acute; Pyrexia; Tympanic membrane perforation	DTAP~UNKNOWN MANUFACTURER~~4~UN~UN~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~1~UN~UN~HEP A (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~4~UN~UN~HIB (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~1~UN~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|PNC~PFIZER\WYETH~~4~UN~UN~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~~1~UN~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0336417	01/02/2009	OH	37.0	37		F	12/29/2008	Has area on L arm located about 2-3 in away from affected area where shot was administered. There were a 2 rounded red areas and then several  other reddened areas- flat not raised. States ache from shoulder to elbow.									Y	12/23/2008	12/23/2008	0	None	PUB	PUB	Lorazepam; Levothyroxine; Famotidine; PRILOSEC; daily vitamins	None	Allergic to PHENERGAN.			1						1	Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U2811AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336418	01/02/2009		72.0	72		M	11/19/2008	Dry, Flaky, Skin, Circular, Itchy.				Y					Y	10/30/2008	11/01/2008	2	Hemoglobin AIC; Metabolic panel comprehensive; Lipoprotein screen panel.	MIL	MIL	ALLOPURINOL; SIMVASTATIN; NISOLDIPINE; LISINOPRIL; COLCHICINE; ASPIRIN; BENADRYL	No illness	Diabetes; High blood pressure; Dermatitis.			1						1	Dry skin; Haemoglobin; Lipoprotein (a); Metabolic function test; Pruritus; Skin exfoliation	FLU3~SANOFI PASTEUR~U2833AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0336420	01/02/2009	MA	37.0	37		F	12/23/2008	Swelling, redness, induration, warmth in posterior upper arm (triceps area);  occurred one mo. after vaccine.									Y	10/22/2008	11/22/2008	31		PUB	UNK		No	No			1						1	Erythema; Induration; Oedema peripheral; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA367LA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|MMR~UNKNOWN MANUFACTURER~D916X~1~SC~RA~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1	USA		Influenza
0336421	01/02/2009	IL	10.0	10		M	12/22/2008	Pt received vaccines below and appeared well with no complaints.  Upon exiting, pt collapsed in hallway.  Pt unresponsive for a short time, with slight confusion following.  ABC's intact with no problem.  EMT's called.  Pt taken to ER per ambulance.  Pt discharged after several hours to home.				Y					Y	12/22/2008	12/22/2008	0		PUB	PUB	None	None	None			1						1	Confusional state; Syncope; Unresponsive to stimuli	FLU3~SANOFI PASTEUR~UT27870A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B019AA~1~IM~RA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1222X~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0336423	01/02/2009	WI	46.0	46		M	12/03/2008	Nov 3rd got flu shot and needle insertion didn't hurt, but it felt like the needle hit something. Reports he had a fireball of pain when medicine injected. For 2 hours pain at injection site #5-6 then decreased #2 until Nov 29, 2008 when pain went up to 8-9 and he could hardly move his arm.									N	11/03/2008	11/29/2008	26		OTH	OTH	Insulin	No	Diabetic; no allergies			1						1	Injected limb mobility decreased; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA380AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0336424	01/02/2009	WI	40.0	40		M	12/07/2008	(2008) Received flu shot Nov 3 & ok until Nov. 22nd.  Woke up and had #6 pain left arm (upper only) with pain to left LUE distal to that.  Still has some pain (#2 at rest), increased #8 with movement.  Pain described as weakness & achy.  No new routine or activity noted post flu shot given to cause pain.  Exercises but not since flu shot.				Y					N	11/03/2008	11/22/2008	19	ER 11/29/08/. Not seen by MD.	OTH	OTH	None	No	No	No~ ()~~0.00~Patient|No~ ()~~0.00~Sibling		1						1	Asthenia; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA380AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0336425	01/02/2009	WI	55.0	55		F	12/08/2008	Received flu shot left deltoid on 11/3/08.  No significant increased pain when administered flu shot as compared with other years when got flu shot.  Continues with pain at injection site # 6 at activity; # 0 at rest.  Denies cons dehersitious (L)UE.  Pain does not radiate past injection site.									N	11/03/2008	11/03/2008	0	None	OTH	PVT	PO: Calcium with D; vitB12; BCG treatments for blood cancer: OCT-> NOV->DEC for 6 wks.	No	Naprosyn. (latex allergy ruled out 2008 by dr notes per test.	None~ ()~~0.00~Patient|None~ ()~~0.00~Sibling		1						1	Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0336426	01/02/2009	WI	48.0	48		F	12/13/2008	Nov 3rd 2008 rec'd flu shot pt sore for 1st couple of days. Ok until Nov. 15 pain (L) shoulder just below acromion #3. Nov 20 call Dr. & used Alleve, Tylenol. Nov 19 pain increased #8 no sleeping. Nov-22 went to ER walkin clinic. Nov 22 pain. #10. Couldn't lift her own arm- someone had to lift arm. Took Alleve, Tylenol and took 1/2 tab of codeine. Now decreased #4. Will follow up with Dr to get physical therapy. No abscess found faxed x-ray.				Y					N	11/03/2008	11/16/2008	13	3 x-ray; CT; Lab tests; IV	OTH	OTH	None	None	None			1						1	Computerised tomogram; Injected limb mobility decreased; Insomnia; Laboratory test; Musculoskeletal pain; X-ray	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA380AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0336427	01/02/2009	WI	33.0	33		F	12/31/2008	Pt reports getting her shot 11/3/2008.  Reports bowling that night and noticing sore arm.  Reports on 11/13/08 noticed she was dropping things.  Having aching pain.  Reports loss of movements.  Reported limited ROM and pain with movements.  C/o numbness in her entire arm.  Evaluated in ER on 12-2-08.  Has F/U apt in Ortho on 12/5/08.  Pt also reports where shot was given it is sore.  Pt asking if injection was given too high.				Y					N	11/03/2008	11/13/2008	10	None	OTH	OTH	ALEVE; TRISPRINTEC	None	None			1						1	Grip strength decreased; Hypoaesthesia; Injection site pain; Joint range of motion decreased; Pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA380AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0336428	01/02/2009	WI	27.0	27		F	12/03/2008	Nov 3, 2008, shot given Nov 4 & 5 sore arm, went away.  Nov 8 & 9 am sore arm around injection site.  Reports some tingling left arm shoulder to elbow posteriorly & occasional tingling to left pinky finger.  Pain aggravated with reaching, pushing, lifting (high up).  Painful at night-wakes him up.  TYLENOL is without relief.									N	11/03/2008	11/08/2008	5	None	OTH	UNK	None	No	Sulfa & Amoxicillin Allergies			1						1	Injection site pain; Pain in extremity; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0336429	01/02/2009	WI	48.0	48		M	12/03/2008	c/o left arm pain. Refusal RN interview. Therefore below is not completed.									U	11/03/2008				OTH	OTH						1						1	Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA380AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0336430	01/02/2009	WI	23.0	23		M	11/13/2008	He received his flu shot on Nov 3, 2008. States 1-2 days after the shot he had stiffness in his arm (left)... Can't lay on it.... have to move it around a lot in the morning to get it going. No changes. Pain comes back stronger after rests for a while.									N	11/03/2008	11/05/2008	2	None	OTH	OTH	None (Tylenol)		No allergies (polyps on sinus surgery)			1						1	Musculoskeletal stiffness; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA380AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0336431	01/02/2009	WI	45.0	45		M	12/03/2008	Flu shot received 11/3/08. States toward the end of November (approx. Nov 12th) he developed an achiness in both shoulders rating it a #5. States elbows also sensitive. (L) elbow ached first then  (R) elbow. Was going to see an MD, but pain disappeared 98% so did not seek medical care.									N	11/03/2008	11/12/2008	9		OTH	OTH	None	None	None			1						1	Arthralgia; Musculoskeletal pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA380AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0336432	01/02/2009	WI	38.0	38		F	12/03/2008	Since 11/3/08- W/E of Nov 8 & 9. -> sender couldn't hardly life her arm - was weak.  On & off ever since.  12/1/08 left arm- had to hold arm close to her body & use right arm to lift left arm.  I had taken ADVIL 200 mg X 6 tabs at one time on evening 11-30-08 for # 8 pain; went down to 2 or 4.  Since then gets bad & goes away for a couple of days.  (Education given on proper dose of ADVIL.)									N	11/03/2008	11/09/2008	6	None	OTH	OTH	ADVIL prn	None	None			1						1	Muscular weakness; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0336434	01/02/2009	WI	41.0	41		M	12/03/2008	On Nov 3, 2008 flu shot given left arm.  Nov 4, noted tensed muscle feel- expected. 8-10 days later right shoulder started hurting in rotator cuff-intensity peaked around 11/27/08.  No further problems with LUE at injection site.  No activity noted unusual with RUE.  No pain radiation RUE + no cons changes.									N	11/03/2008	11/12/2008	9	None	OTH	OTH		No	Allergy to PCN	NONE~ ()~~0.00~In Patient|NONE~ ()~~0.00~In Sibling		1						1	Musculoskeletal pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0336403	01/05/2009	NC	60.0	60		M	12/23/2008	Chest tightness, shortness of breath, and rapid demise to death within 4 hours of receiving vaccine. 1/7/09-records received for ED DOS 9/29/08-presented to ED with C/O chest pain, while enroute to ED became diaphoretic, SOB required cardioconversion, intubation. V fib. DX and COD-Pulmonary embolus.  Expired 9/29/08. 2/9/09-COD-pulmonary embolism.	Y	09/29/2008		Y					N	09/29/2008	09/29/2008	0	1/7/09-records received-Chest x-ray infiltrate at left lung base and possible infiltrate right upper lobe.	PVT	PVT	LEVAQUIN; LOPRESSOR; NEURONTIN; ELAVIL	No acute illness	Pernicious anemia; CAD; MI; Lumbar disc disease; Peripheral neuropathy; Hypothyroidism; Cardiomyopathy; GERD; Cervical disc disease; Nonunion R hip fx-repaired; AODM; BPH; MOTRIN; MYCARDIS; PREVACID; FLOMAX; trimethoprim 1/7/09-records received-PMH: CHF, pancreatitis, UTI, Diabetic, coronary stents. Stroke.			1						1	Chest discomfort; Death; Dyspnoea	FLU3~SANOFI PASTEUR~42762AA~4~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0336404	01/05/2009	CT	0.51	0	.5	F	12/24/2008	Received flu vaccine 12/8. On 12/10 developed fever and seizures. Sepsis work up negative, head CT negative. Dx: complex febrile seizures. 3/3/09-records received-on 12/10/08 2 episodes brief stiffness and eyes rolling back during fever of 103.7. 12/11/08-additional episodes of stiffness and eyes rolling back.					Y	2			Y	12/08/2008	12/10/2008	2	EEG; LP; CT scan; Blood culture - all negative 3/3/09-records received-Head CT normal.	PUB	PUB	None	None	None			1						1	Blood culture negative; Computerised tomogram normal; Convulsion; Electroencephalogram normal; Febrile convulsion; Lumbar puncture normal; Pyrexia	FLU3~SANOFI PASTEUR~UT2797EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0336405	01/05/2009	TN	59.0	59		F	12/27/2008	Severe congestion-nasal,ears,head - vision and hearing. Severe headaches. Chills - cold sweats- fever, severe weakness, confusion- very, very bad!!!. Dizziness- all the worse than the flu!!. 12/27/08 still weak and congested, my vision and hearing still damaged.  1/09/2009 MR received from HD for OV 1/8/09 with DX: Serous otitis by hx.  Adverse effects Flu shot. Pt presented with c/o dizziness, confusion, head congestion ear popping, and hearing a cricket-like sound in her ears. Sx lasted 7 days except R ear still popping. Now c/o weakness and decreased vision. PE WNL except vision. Referred to ophth. Follow-up: On Thursday January 8, 2009 I was examined by Dr. at the county health dept. I had never been seen by Dr. before, but rather by whom I desire to continue seeing as long as I live in this county---I trust her sincerely. Upon my exam I complained of flu like conditions that began soon after receiving a flu vaccine. On that office visit I was suffering from flu-like intestinal condition. That had started around 01-02-09---I was still very week, body aches congestion, hoarse throat and of course my most concern ...the impaired vision and hearing. No in-house blood work (pricking of finger to discern viral vs bacterial) was taken!! No X-rays were given or requested! Lungs...ect. And the most disturbing---no referrals for eye exam or ear and throat specialist --- event though I requested those. Therefore I will arrange these appointment on my own and will share the conclusions with VAERS and the courts. Disclosure. When I first filed the VAERS report dated 12-27-08 I was not aware that my mother's ER admission and several days stay to hospital ---in November of 2008- - had anything to do with the flu vaccine .....however, on Friday January 9, 2009 I was informed that indeed she did suffer a major adverse reaction!								Y	N	12/16/2008	12/17/2008	1		PUB	UNK	PROTONIX; BP meds					1						1	Asthenia; Chills; Cold sweat; Confusional state; Dizziness; Headache; Hearing impaired; Hyperhidrosis; Nasal congestion; Pyrexia; Respiratory tract congestion; Visual impairment	FLU3~SANOFI PASTEUR~U2802AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0336410	01/05/2009	PA	39.0	39		M	11/11/2008	Redness and swelling around vaccination site with warmth.  Pt took BENADRYL 11/7/08 and  IBUPROFEN X several days.  Saw family practitioner.  Pt had already received a dose of PNEUMOVAX 2 years ago.  MD attributed severe rxn to short time frame between doses.  Pt recovered by 11/10/08.				Y					Y	11/05/2008	11/06/2008	1		OTH	PVT	Unknown	None	Asthma			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88117~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0669X~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0336412	01/05/2009	UT	38.0	38		F	12/29/2008	3 days following Flu vax developed pain and tenderness LUE with decreased ROM persist Sx as of 12-29-08.									N	11/12/2008	11/15/2008	3		PVT	UNK		No	No			1						1	Injected limb mobility decreased; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89971~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0336413	01/05/2009	OR	48.0	48		F	12/29/2008	Severe pain 10/10 in deltoid area rad. down biceps area also into shoulder/neck. This was flu shot #2 alt recall of first vaccine by manufacturer.				Y					Y	10/24/2008	10/25/2008	1		PVT	PVT		None	None			1						1	Musculoskeletal pain; Neck pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881175P~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0336414	01/05/2009	IA	45.0	45		F	12/24/2008	About 4 weeks after the f/u shot, I experienced joint pain, in the foot, ankles, knees, neck, arm, elbow and hand. 2/10/09 Received PCP medical records of 12/16-12/18/2008. FINAL DX: joint pain Records reveal patient experienced joint pain x approx 2 weeks.  Seen by accupuncturist 12/15.  Exam was WNL.  Tx w/meds & labs done.				Y						10/23/2008	11/25/2008	33	lab work done LABS: ANA neg.  RA factor <20(N).  CRP 1.8(H).  ESR 31 (H).  WBC 11.5(H), lymphs 17%(L).	PVT	UNK	No	No	No			1						1	Arthralgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA374AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0336415	01/05/2009	IL	6.0	6		M	12/19/2008	Child was struggling before shot- held by father.  Shot was administered to L arm.  Child looked up at mom and smiled then became briefly limp, responded to parents but then again became momentarily weak kneed.  Then appeared back to normal- talking, smiling, putting own coat on.  Seen by MD. B/P 110/58.									Y	12/18/2008	12/18/2008	0	None	PUB	PUB		None	Cochlear implant			1						1	Asthenia; Hypotonia	FLU3~SANOFI PASTEUR~UT2787DA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336440	01/05/2009	KY	19.0	19		M	01/05/2009	Patient complains of generalized urticara with tightness in chest.  Swelling of the tonsils was observed, however patient denied any prior illness.				Y					U	01/05/2009	01/05/2009	0		MIL	MIL	Unknown	Patient denys prior illness	None Known			1						1	Chest discomfort; Tonsillar hypertrophy; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500584P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHBVB531AA~UNK~IM~LA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0336441	01/05/2009	KY	20.0	20		M	01/05/2009	Patient observed having trouble breathing.  Patient had altered mental status.  Patient did not improve after epi-pen administration.				Y					U	01/05/2009	01/05/2009	0		MIL	MIL	Unknown	No illness reported	No alergies/prior medical conditions reported			1						1	Dyspnoea; Mental status changes	FLUN3~MEDIMMUNE VACCINES, INC.~500584p~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~ahavb251aa~UNK~IM~LA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0336444	01/05/2009	NC	6.0	6		F	01/05/2009	PATIENT SEEN FOR WELL CHILD VISIT ON 12-29-2008, RECEIVED VARICELLA, HEPATITIS A, AND FLU VACCINES.  PARENT CALLED ON 12-30-2008 WITH POSSIBLE REACTION TOLD TO COME IN, APPOINTMENT MADE FOR SAME DAY.  PATIENT SEEN BY DR DIAGNOSED AS VACCINE REACTION GIVEN PRESCRIPTION FOR ATARAX AND COOL COMPRESSES, IF WORSENS TO RETURN TO CLINIC.									Y	12/29/2008	12/30/2008	1	N/A	UNK	UNK	NONE	NONE	NONE			1						1	Vaccination complication	FLU3~SANOFI PASTEUR~U2805AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB257AA~2~IM~LA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1221X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0336456	01/05/2009	SD	59.0	59		F	01/05/2009	Got flu shot on 12/2/08 and on 12/4/2008 had severe pain and edema in ankle and foot and with in a week total joint involvement. MD visit follow week for the issue and MD opinion was an immune response to the flu shot. Serum sickness ruled out because of duration of symptoms. Best guess was flu shot triggered an immune repsones that opened the door for Rheumtoid Arthritis.				Y					Y	12/02/2008	12/04/2008	2	Rule out Lupus.	PUB	PUB		None	Fiber Myalgia, Diabetes			1						1	Arthralgia; Fibromyalgia; Oedema peripheral; Pain in extremity; Rheumatoid arthritis	FLU3~SANOFI PASTEUR~U2760AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0336459	01/05/2009	FL	65.0	65		M	01/05/2009	within 2 days developed ipsilateral upper arm numbness and pain and tingling into the L hand.  Within a few days, ipsilateral thigh had numbness and formication.  Shot was given into L deltoid.									Y	10/03/2008			none	PVT	PVT	lisinopril and aspirin	no	HTN			1						1	Formication; Hypoaesthesia; Pain in extremity; Paraesthesia	FLU3~SANOFI PASTEUR~u2745aa~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0803u~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0336463	01/05/2009	OH	1.3	1	.3	M	12/30/2008	Initial information was received on 23 December 2008 from a health care professional. A one year old male patient with a runny nose at the time of vaccination received an intramuscular left thigh injection of FLUZONE No Preservative 2008-2009 (lot number UT2782EA) on 17 November 2008. A few days post vaccination the child had twitching of the body and head jerking. The symptoms ended but began to occur again. The symptoms were more pronounced and lasted for ten minute intervals. The patient required a doctor's visit. The patient was not recovered at the time of the report. No further information was provided. List of Documents held by Sender: None.				Y					N	11/17/2008			Not reported.	PVT	PVT		The patient had a runny nose at the time of vaccination.	The patient had a runny nose at the time of vaccination with no reported past medical history.		200804076	1						1	Dyskinesia; Muscle twitching	FLU3~SANOFI PASTEUR~UT2782E~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0336466	01/05/2009	NY	41.0	41		F	01/05/2009	This case was reported by a lawyer and described the occurrence of joint pain in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced severe joint pain of the hands, feet, shins, knees, shoulders, elbows, wrists, and palms, eye redness, blisters in the corner of the eye, cough, pin in the foot, pain with walking, tinnitus, stiffness, fatigue, reflux symptoms (nos), chest pain, eye twitching, cold intolerance, and activities of daily living impaired. The statement further alleged that the subject experienced rheumatologic, neurologic, and/or cognitive sequella of an autoimmune, immune-mediated, or other biological mechanism, all caused by vaccination with LYMERIX, including but not limited to those symptoms set forth above. At the time of reporting the outcome of the events was unspecified. Follow up information was received on 05 January 2009 via medical records. The subject received her first LYMERIX vaccine on 26 April 1999. She received her second LYMERIX vaccine in approximately September 1999 or October 1999, along with an influenza vaccine (unknown manufacturer). In March 2000, she developed episcerlitis with eye redness. On 05 May 2000, she complained of arthralgias and ongoing episcleritis. On 23 May 2000, she was evaluated for complaints of hand pain. A progress note dated 25 May 2000 indicated that the subject was diagnosed with sarcoidosis secondary to Lyme vaccine. Treatment included VIOXX. On 02 October 2000, she was evaluated for a five-day history of dry cough, aches, and fatigue, in addition to the sarcoid affecting her eye. Impression included upper respiratory infection, most likely viral. On 31 January 2002, she was seen by an allergy specialist who diagnosed cough and allergic rhinitis. According to a physician's note dated 18 March 2002, the subject had a history of questionable sarcoid secondary to Lyme vaccine, but was seen subsequently by a pulmonary consultant who did not feel that she had a sarcoid. Treatment included steroids and antibiotics. On 02 July 2003 she complained of chest pain, with a chest x-ray showing no acute pathology. On 11 July 2003, the subject was seen after presenting to the emergency room due to sudden onset of substernal chest pain that worsened with deep breathing. Treatment included Toradol, and she was diagnosed with costochondritis and was discharged. At the time of examination on 11 July 2003, the subject noted fatigue associated with Lupron injections to regulate her menstrual period. Impressions included 1) costochondritis, resolved, 2) probable viral illness, and 3) fatigue possibly secondary to Lupron. On 12 March 2007, she was evaluated for incapacitating tinnitus treated with steroids including prednisone. Other conditions included chronic episcleritis, synovitis, and leukocytosis. Methotrexate was prescribed at that time for treatment of autoimmune disease. She also continued to experience arthralgias.								Y	U	09/01/1999			Diagnostic results: 05 May 2000: B. burgdorferi Ab (IgG and IgM) by Western Blot negative. B. burgdorferi Ab screen 2.43; positive. 10 May 2000: Lyme ELISA positive, Western Blot negative. 23 May 2000: X-rays of right and left hands and wrists were normal. HLA-B27 negative. Angiotensin converting enzyme 63.3 U/L. 04 September 2003: Normal stress echocardiogram. 24 January 2007: Magnetic resonance imaging of brain/1AC region with and without contrast showed no evidence for acoustic neuroma or other significant abnormality; mild maxillary and ethmoid sinus disease.	OTH	OTH		Diverticulosis; Gastroesophageal Reflux Disease; Hiatal Hernia	Broken nose; Cat scratch fever, Ex-smoker; The subject smoked one and a half packs of cigarettes per day since age 15, stopped in approximately 1992. Family history of arthritis (mother).		A0759678A	1						1	Activities of daily living impaired; Angiotensin converting enzyme increased; Arthralgia; Autoimmune disorder; Blepharospasm; Blister; Borrelia burgdorferi serology positive; Chest pain; Cognitive disorder; Costochondritis; Cough; Echocardiogram normal; Episcleritis; Fatigue; Gastrooesophageal reflux disease; HLA marker study; Immunology test; Immunology test abnormal; Leukocytosis; Musculoskeletal pain; Musculoskeletal stiffness; Neurological symptom; Nuclear magnetic resonance imaging brain abnormal; Ocular hyperaemia; Pain; Pain in extremity; Paraesthesia; Rhinitis allergic; Sarcoidosis; Stress echocardiogram; Synovitis; Temperature intolerance; Tinnitus; Upper respiratory tract infection; Viral infection; X-ray limb normal	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|LYME~GLAXOSMITHKLINE BIOLOGICALS~~2~UN~UN~LYME (LYMERIX)~1	USA	Disabling	Influenza
0336476	01/05/2009	NY	17.0	17		F	11/20/2008	She received flu shot and Pneumovax in different arms on 11/11/08 . Later that day she developed L arm soreness with fevers to 102 degrees F. Also chills, aches, headache, back pain, Emesis x1. She had an indurated red rash on left deltoid with significant tenderness. I treated her with prednisone, Benadryl and T#3. Labs showed increased WBC, elevated CRP, elevated SED, elevated LFT Urine was. Slowly improving will recheck labs in 1 week.									Y	11/11/2008	11/11/2008	0	WBC, 16.3; AST, 48; ALT, 75; CRP, 73; SED, 37	PVT	PVT		No	Asthma, GERD, has Sulfa Allergy			1						1	Aspartate aminotransferase increased; Back pain; C-reactive protein increased; Chills; Headache; Injection site induration; Injection site pain; Injection site rash; Liver function test abnormal; Pain; Pyrexia; Red blood cell sedimentation rate increased; Vomiting; White blood cell count increased	FLU3~SANOFI PASTEUR~U2795DA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1407X~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0336477	01/05/2009	NY	65.0	65		M	12/09/2008	Patient was given PNEUMOVAX and Flu shot on 11/11/08 he developed chills and significant aches and fatigue later that day. Had a large red rash at site of vaccinations with arm pain. Took several days to improve without treatment.									Y	11/11/2008	11/11/2008	0	No testing done.	PVT	PVT		None	HTN; DM; Gout; Bladder Cancer; Carotid Stenosis			1						1	Chills; Fatigue; Injection site erythema; Injection site rash; Pain; Pain in extremity	FLU3~CSL LIMITED~01749111A~UNK~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~1407X~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0336479	01/05/2009	NY	29.0	29		F	11/20/2008	She developed severe right arm pain a few hours after the shot. Had chills and continued arm pain. Developed a blotchy red indurated rash on right deltoid area. Was seen in urgent care on 11/12/08 and in the office on 11/14/08. I treated her with steroids and pain medication on 11/14/08. She had received flu shot in same arm as PNEUMOVAX.				Y					Y	11/11/2008	11/11/2008	0		PVT	PVT		No	Asthma; Migraines; Anxiety			1						1	Chills; Injection site erythema; Injection site induration; Injection site rash; Pain in extremity; Rash macular	FLU3~CSL LIMITED~01749111A~UNK~UN~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~1407X~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0336482	01/05/2009	MI	66.0	66		M	12/29/2008	On 12-22-08 Patient received PNEUMOVAX around 230. At midnight woke up left arm sore at injection site at 2am woke up pain at injection site radiating down arm to hand , fingers unable to lift arm. Patient took 2 MOTRIN at 2am by 8am pain gone, showed no problems since.									Y	12/22/2008	12/23/2008	1		PUB	PUB	None	None	None			1						1	Injected limb mobility decreased; Injection site pain; Pain in extremity	FLU3~SANOFI PASTEUR~02847AA~2~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0619X~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0336483	01/05/2009	FL	66.0	66		F	12/18/2008	Possible reaction to vaccine 1-2 days after administration.  Nauseous, dizziness, headache, ringing in the ears.  Was exposed to grand children just prior to vaccine who were very ill with the flu - like symptoms.  Comes and goes - lasts for 15 minutes.										10/08/2008	10/09/2008	1		OTH	PUB	None	None	None			1						1	Dizziness; Headache; Nausea; Tinnitus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89968~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0336484	01/05/2009	VA	69.0	69		F	12/23/2008	Muscle pain (next morning) extending down arm to fingers - around left shoulder blade.   Shortness of breath - red (hives) fever. Pt called MD.  Told to take BENADRYL.  Not better go to acute care or ER - Still on 12/19 - sore some swelling.									Y	12/12/2008	12/21/2008	9		PVT	UNK	BUMEX 2mg					1						1	Dyspnoea; Musculoskeletal pain; Myalgia; Swelling; Urticaria	FLU3~SANOFI PASTEUR~42853AB~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336491	01/05/2009	IN	5.0	5		F	12/29/2008	Mother called, daughter is very weak, cannot keep eyes open. Llips are pale. Weak. Told mother to take her to ER. Took to ER -started feeling better, so left and took to MD. MD stated child had nervous reaction to shot and not vaccine reaction. Child fine at this time.				Y					Y	12/29/2008	12/29/2008	0		PUB	PUB		None	None Known			1						1	Asthenia; Nervousness; Pallor	FLU3~SANOFI PASTEUR~U2792AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0336492	01/05/2009	FL	50.0	50		F	12/29/2008	Heat, tenderness, erythema left upper arm no fever- probable allergic reaction.  Could not rule out cellulitis.									U	12/19/2008	12/20/2008	1	None	PVT	PVT	NAPROXEN; Multivitamin; flu shot	None	Breast cancer; allergy to LETROZOLE			1						1	Erythema; Hypersensitivity; Skin warm; Tenderness	FLU3~SANOFI PASTEUR~U2764AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336494	01/05/2009	GA	34.0	34		F	12/24/2008	3 1/2 X 5 inch raised, erythematous area to right deltoid warm to touch.  Vaccine given 12-22-08, reaction began on 12-23-08 around 1:00 pm.  Reaction evaluated 12/24/08 @ clinic.  Instructed ct if redness, swelling increases she need to go to ER.  Due to Holiday ct to RTC 12-29-08 for reevaluation.  12-29-08 ct rtc for re-evaluation; erythema at swelling minimal.  Ct went to ER 12-24-08. Given SOLUMEDROL, BENADRYL, pain medication.  Release of information sent to ER for visit records.				Y					Y	12/22/2008	12/23/2008	1	None	PUB	PUB	KALETRA; BUSPAR; TRUVACH	No	HIV positive			1						1	Erythema; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U2804AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0554U~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0336502	01/05/2009	VA	21.0	21		F	01/05/2009	Received AVA #2 on 10/28/08.  Reported to clinic 2 weeks later (11/11/08) for AVA #3 and showed positive HCG test.  Third AVA held.  Symptoms:  Amenorrhea.  First OB visit was 12/11/08 and placed on Iron supplements.  Iron panel and 2nd trimester US ordered.  PT seen in ER in other country X 2 with vaginal spotting and abd cramping.  Diagnosed w/threatened AB and anemia (12/19 and 12/27).  Email from pt on 12/27/08 4:38 AM stated preg and baby were well, then in ER that evening 1903 with 5 minutes of vag spotting.  No active bleeding noted but test results showed decreasing Quant hcg: 12/19 = 56,337 and 12/27 = 39,133.68 and anemic: RBC 3.56, hgb 33.5 and hct 35.8.  Current GC/KOH/wet prep and chlymadia all negative.  TV 12/19/08 = IUP w/active fetus.				Y					U	09/24/2008	11/11/2008	48	10/10/2008, negative urine HCG; 11/12/2008, positive urine HCG	MIL	MIL	none	none	none			1						1	Abdominal pain; Abortion threatened; Amenorrhoea; Anaemia; Chlamydia identification test negative; Drug exposure during pregnancy; Genital haemorrhage; Haematocrit normal; Haemoglobin increased; Red blood cell count decreased; Ultrasound scan normal; Urine human chorionic gonadotropin positive	ANTH~EMERGENT BIOSOLUTIONS~FAV173~UNK~SC~UN~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500550P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0336503	01/05/2009	VA	15.0	15		F	05/15/2008	SM reported receipt IM Influenza age 16-17 (1997-98) with development red rash.  Told not to take again....no documentation available.  No other symptoms.  Rash, diffuse Start:  1998 End:  1998 Comment:  782.1 unknown history A/I referral given 2007 X 2: not tested				Y					Y	01/01/1998			12/3/07:  A/I note:  Due to the patient's clinical symptoms after receiving the flu shot I would recommend that the patient continue to avoid the flu vaccine.  There is no further testing necessary at this time.	PVT	OTH	denied		seasonal allergies			1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0336504	01/05/2009	CA	1.1	1	.1	F	12/31/2008	13 mo brought by mom for over 1 week h/o small knot right anterior thigh after vaccinations.  No pain or discomfort.  Small 1 diam. area of non tender induration not 1 right anterior thigh today, afebri asymptomatic.									Y	12/19/2008	12/24/2008	5		MIL	MIL		None	AMOXICILLIN			1						1	Injection site induration; Injection site pain; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~UT27881A~1~IM~LL~INFLUENZA (SEASONAL) (FLUARIX)~1|MMR~MERCK & CO. INC.~1082X~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~076281~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1136X~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0336505	01/05/2009	TX	60.0	60		F	12/30/2008	Patient left arm still sore.  Hard to grasp or lift heavy objects.  Vaccine given on 12-4-08.  No treatment given at this time.									U	12/04/2008	12/05/2008	1		OTH	PVT	Unknown	None	Unknown			1						1	Tenderness	FLU3~SANOFI PASTEUR~V2741AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336509	01/05/2009	PA	37.0	37		F	01/05/2009	Patient had suspected immune reaction. Patient has lost sleep. Arm has pain without swelling. Patient has seen doctor and has had Medrol DP + Sleep medication. Symptoms have improved as of 1/5/09, but are still ongoing.									U	11/18/2008	11/19/2008	1	None at our facility	OTH	OTH		None				1						1	Insomnia; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA7165AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0336510	01/05/2009	MA	57.0	57		M	01/05/2009	Pain at injection site x 2 days. On 3rd day radiated to L shoulder at deltoid. Constant throbbing pain, restricts mobility. Severe enough to wake from sleep. On going problem.				Y					U	11/21/2008	11/22/2008	1	X-ray of shoulder; MRI	OTH	OTH		No	None now			1						1	Injection site pain; Mobility decreased; Pain; Sleep disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA191AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0336512	01/05/2009	GA	14.0	14		M	11/06/2008	Pt received vaccine on Friday.  Saturday night pt noticed site where he received the vaccine was itching and he had developed a rash that was about 5 in X 2 in with a darker red raised rash in the center that was about one inch in diameter.   Pt. noticed no other signs or symptoms other than itching and rash on back of (R) upper arm.									U	10/31/2008	11/01/2008	1		PUB	PUB					GA08088	1						1	Injection site pruritus; Injection site rash	FLU3~SANOFI PASTEUR~U2829AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB291BA~1~UN~LA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1002X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0336551	01/06/2009	WI	53.0	53		F	12/29/2008	11/30 T 101 Dr. ran rapid strep -> negative continue to have ear and sinus trouble. 12/18 Dr. irrigated (L) ear (perforated) & did sinus x-rays.				Y					U	11/10/2008	11/12/2008	2	My physician did no testing.	PVT	PVT	LIBRA X TID prn->ID ; VALTREX 500 mg daily; LISINOPRIL 10 mg daily; ADVAIR.	None	Allergy to: Sulfa; Erythromycin; Morphine; Biaxin	Never had a problem with vaccines~ ()~~0.00~In Patient|Brothers don't get flushot~ ()~~0.00~In Sibling		1						1	Body temperature increased; Ear discomfort; Sinus disorder; Streptococcal identification test negative; X-ray	FLU3~SANOFI PASTEUR~U2791EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0336553	01/06/2009	MA	1.0	1	.0	M	12/30/2008	Vaccines administered in L thigh on 12/18/08.  On 12/26/08, 4 vesicles appeared @ injection site.  Slight firm mass underneath, some discomfort.									U	12/18/2008	12/26/2008	8	None	PVT	PUB	None	None	None			1						1	Injection site discomfort; Injection site induration; Injection site mass; Injection site vesicles	FLU3~SANOFI PASTEUR~UT2783FA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB258AA~1~IM~RL~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1152X~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0336555	01/06/2009	AL	64.0	64		F	12/31/2008	Approximately 1 wk following injection: large hives 4 to 6 (blister like) on both legs from knee to hip for about 1 week- shooting pains in hands-followed by numbness in fingers- now in finger tips and pain in Achilles tendons (still hurts but not so acute) still injured and shortness of breath.									N	11/13/2008	11/19/2008	6		PUB	UNK		None	Penicillin			1						1	Angioedema; Blister; Dyspnoea; Hypoaesthesia; Pain; Pain in extremity; Tendon pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89976~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1163X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0336557	01/06/2009	LA	18.0	18		F		Increased headache, increase menstrual periods (3 in 2 months).									N	10/28/2008				PVT	PUB		Sinus/congestion				1						1	Headache; Menstruation irregular	FLU3~SANOFI PASTEUR~U2790AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2729AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0336558	01/06/2009	CA	4.0			F	12/12/2008	Site of DTaP on L deltoid very red, swollen, hot to touch, site of flu shot on R deltoid also very red, swollen and hot to touch.									Y				None	PVT	PUB	QVAR;  XOPENEX; CLARITIN	None	None known			1						1	Injection site erythema; Injection site swelling; Injection site warmth	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B087BA~5~UN~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2833AA~4~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1120X~2~UN~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1148X~2~UN~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0336560	01/06/2009	IL				F		4 female school teachers c/o S.O.B. & wheezing to school nurse - treated with Ibuprofen.									Y	10/30/2008	10/30/2008	0		PVT	PVT						1						1	Dyspnoea; Wheezing	FLU3~SANOFI PASTEUR~U2772AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336583	01/06/2009	IL	65.0	65		F	01/05/2009	Information has been received from a physician concerning a 65 year old female who was vaccinated with a second 0.5 ml dose of PNEUMOVAX 23. On the same day the patient also received a dose of flu vaccine in the same arm. Recently, the patient developed a severe injection site reaction and was hospitalized for 2 days. The patient was treated with intravenous antibiotics. Subsequently, on an unspecified date, the patient recovered. Follow up information was received from a registered nurse (R.N.) who reported that the retired female with chronic obstructive pulmonary disease, allergy to penicillin, clarithromycin, metronidazole and isoniazid, asthma and hypertension and emphysema who at 12:45 pm of 17-OCT-2008 was vaccinated in her left deltoid with a second dose of PNEUMOVAX 23 (lot #657526/0555U) and a dose of FLUZONE (lot #U2805AA). There was no illness at the time vaccination. Concomitant therapy included tramadol HCl, ADVAIR, hydrochlorothiazide, aspirin, prednisone, EFFEXOR XR, theophylline, AMBIEN, ULTRAVATE, AZULFIDINE, lisinopril-HCTZ, albuterol and tiotropium bromide. In the P.M. of 17-OCT-2008 the patient experienced increasing pain and redness at injection site, fever, chills, shortness of breath, nausea, vomiting, headache and stiff neck and was hospitalized (4 days). Blood culture was negative. On 24-OCT-2008, the patient recovered. Additional information is not expected.				Y	Y	4			Y	10/17/2008	10/17/2008	0	diagnostic laboratory, negative blood examinations	PVT	PVT	albuterol; aspirin; ADVAIR; ULTRAVATE; hydrochlorothiazide; ZESTORETIC; prednisone; AZULFIDINE; theophylline; tiotropium bromide; tramadol hydrochloride; EFFEXOR XR; AMBIEN	Chronic obstructive pulmonary disease; Penicillin allergy; Allergic reaction to antibiotics; Drug hypersensitivity; Asthma; Emphysema; Hypertension			WAES0811USA02209	1						1	Blood test normal; Chills; Dyspnoea; Headache; Injection site erythema; Injection site pain; Musculoskeletal stiffness; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2805AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0555U~2~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0336603	01/06/2009	MD	48.0	48		F	01/06/2009	Post viral symptoms 4 weeks post Influenza vaccine, increased difficulty ambulating x 4 weeks myalgias, neuropathies, evaluated by ER physician on 12/12/08.  2/5/09 Received ER medical records of 12/20/2008. FINAL DX: left leg pain Records reveal patient experienced difficulty w/weakness since 10/9/08 flu shot.  States had flu symptoms shortly after shot & had been having muscle ache of left leg since.  On 12/20 had muscle spasms & pain in left leg & it gave out, was unable to bear weight on left leg.  Neuro consult done & was WNL.  Tx w/meds & d/c to home.  Referred to Ortho.				Y					N	10/09/2008	11/09/2008	31	LP, lab work, venous doppler L LE, Xray LLE  LABS: CBC & chemistry WNL.  Left leg x-ray WNL.	UNK	UNK	MVI, prenatal Vitamin, Vit E	None	Codeine, Valium, Sodium Pentathol, Sulfa, PCN, metal allergy  PMH: environmental allergies.			1						1	Gait disturbance; Lumbar puncture; Myalgia; Neuropathy peripheral; Ultrasound Doppler	FLU3~CSL LIMITED~04549111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0336605	01/06/2009	MA	1.25	1	.3	F	01/06/2009	Patient had a seizure two hours after recieving the vaccine.  She had no history of seizures and she did not have a fever at the time				Y					Y	10/21/2008	10/21/2008	0		PVT	PUB	Multivitamin with fluoride and Loratadine PRN	None	allergic rhinitis			1						1	Convulsion	DTAP~SANOFI PASTEUR~U2356CA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT2792EA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C87338~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0336610	01/06/2009	MA	9.0	9		F	01/06/2009	Pt presented with approx 5 cm area of redness, sl warmth but minimal swelling. Mildly tender.  No streaking. Rx'd Tylenol or Motrin for discomfort.				Y					Y	03/19/2008	03/20/2008	1		UNK	UNK	OMEPRAZOLE 20 MG CAP, DELAYED RELEASE SOLIA 0.15 MG-30 MCG TAB (DESOGESTREL-ETHINYL ESTRADIOL) FLUCONAZOLE 150 MG TAB LORATADINE 10 MG TAB	Chronic vomiting assoc with history of esophageal dilatation.	Allergic to pollen, chronic vomiting.			1						1	Erythema; Skin warm; Swelling; Tenderness	FLU3~SANOFI PASTEUR~U2501AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB171AA~1~IM~LA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~1740U~2~IM~LA~HPV (GARDASIL)~1|TDAP~SANOFI PASTEUR~AC52B016BA~1~IM~RA~TDAP (ADACEL)~1|TYP~SANOFI PASTEUR~A04462~1~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|VARCEL~MERCK & CO. INC.~1759U~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0336611	01/06/2009	CO	45.0	45		F	01/06/2009	Fever of 101 -102, body aches, and fatique x 4 days.									Y	01/02/2009	01/03/2009	1		PVT	UNK	Symbicort	dry cough x 3 months, doctor prescribed Symbicort	Celiac Sprue	hospitalized with fever of 105~Measles + Mumps + Rubella (no brand name)~NULL~1.30~In Patient		1						1	Fatigue; Pain; Pyrexia	FLU3~SANOFI PASTEUR~~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336615	01/06/2009	PA	1.04	1	.0	M	01/06/2009	Vesicles noted on right arm near site of varicella administration.									U	12/22/2008	01/03/2009	12		PVT	PVT						1						1	Injection site vesicles	FLU3~SANOFI PASTEUR~UT2782EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1362X~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~D16284~4~IM~RA~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1223X~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0336625	01/06/2009	FL	52.0			F	12/29/2008	A serious spontaneous report of Bell's Palsy has been received from a Registered Nurse concerning a 52-year-old female subsequent to FLUMIST. Medical history and concomitant medications were not reported. On 05-Oct-2008, the patient received FLUMIST. On 05-Nov-2008, the patient started to experience tingling and numbness. Subsequently, the symptoms became more prominent and a neurologist diagnosed her with BELL's Palsy. The event was ongoing. The sponsor considered the event of BELL's Palsy to be serious (important medical event).									N	10/05/2008	10/05/2008	0		OTH	OTH	Concomitant drug (s) not reported				MEDI0007688	1						1	Facial palsy; Hypoaesthesia; Paraesthesia	FLUN3~MEDIMMUNE VACCINES, INC.~500551P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0336626	01/06/2009	ME	0.6	0	.6	M		This is a previously health 8-month-old boy with a 2-week history of runny nose and cough without fever. Three days prior to admission he developed a fever which has been a T-max of 103. He was seen in the emergency department at his referring hospital two days prior to this admission at which point he was diagnosed with bilateral otitis media. Labs were not drawn at that time. He was started on azithromycin orally for which he had received two doses when he returned to the emergency department last night due to persistent fever and irritability. At that point his bulging fontanelle was noticed and he was empirically given a dose of IM ceftriaxone 100 mg hg. Note that a lumbar puncture was attempted and yielded only a few drops of apparently bloody CSF. It is unclear to me in talking with the lab whether this was actually received by the lab. A blood culture was obtained and that is pending. Finally a urine culture was obtained, but the lab also does not have this specimen. The patient was then transported by a team originating from that hospital. He had an 10 in place as both peripheral and central access were unsuccessful. 1/6/09-records received for DOS 11/22/08-12/29/08-DC DX: Streptococcus meningitis. Streptococcus Bacteremia.admitted with C/O two week history of rhinorrhea and cough and 3 day histoy of fever to 103. Bilateral otitis media 2 days prior to admission. Irritability. Bulging fontanelles.			Y		Y	25			Y	11/16/2008	12/19/2008	33	1/9/09-records received-Urine culture negative. Lumbar puncture increased protein of 317, increased opening pressure, WBC 741 with 71 polys and normal glucose. CSF gram positive cocci in pair. Blood culture streptococcus pneumoniae. WBC 20.6, increased CRP 37.1, CT increased intracranial pressure.	PVT	PUB	None	None 1/6/09-records received-two week history of rhinorrhea and cough and 3 day histoy of fever to 103. Bilateral otitis media 2 days prior to admission.	Crytorehism (rt)		ME00109	1						1	Fontanelle bulging; Irritability; Pyrexia	DTAP~SANOFI PASTEUR~C2957AA~3~UN~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2792EA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A10602~3~UN~~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~C52997~3~UN~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0280X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Life Threatening,Hospitalisation	Influenza
0336627	01/06/2009	PA	71.0	71		M	01/06/2009	On November 10 pt received Flu vaccine. At 9:30 am. After the vaccine he went to the dentist who prescribed an antibiotic for the tooth infection. On the 12 of November (Thursday) at midnight patient started to feel pain in his hip, right leg, left leg, and the elbow. While he was at home he took over the counter head ache pills. At the ER at the Hospital was prescribed oxycodone. He started losing hearing and also lost memory while he was taking this medication at home. Gradually, also had vomiting, prescribed COMPAZINE. Right hand began shaky, could not hold anything. Excess of sleeping. Slept during 15 hours a day. Patient did not eat during 3 weeks lost 30 pounds. He drank more water and fruit juice while he was at home. After all these episodes pt. went to the ER Hospital twice, where he had cat scans. After pt was discharged on the 4 of December, gradually hearing began to come back as well as appetite.   2/2/09 MR received fro ER visit 11/28/2008 with DX: depression.  Neuro consult Impression:  Increased Anxiety from baseline.  30 lb weight loss-r/o metastasis vs depression.  Hand tremor.   Pt presented with c/o increased anxiety, difficulty concentrating, 30lb wt loss in 3 weeks, headaches and hearing loss. Pt had felt ill since 2 days s/p Flu shot on 11/11/08 with fever, flu-like sx, nausea, H/A and confusion. Saw dentist for tooth infection. Rx: abx. PE (+) for visual apraxia, L flapping tremor, (+) intention tremor, (+) Romberg. Referred for psych consult due to recent losses.  DX:  MDD, Anxiety, Adjustment reactions. Referred for outpt f/u.				Y	Y	1			U	11/11/2008	11/12/2008	1	Many labs and tests. Labs and Diagnostics:  CT scans (-). EKG abnormal.  CBC with WBC 10.9, RBC and Hct sl low. Na+ 133.  Glucose 117.  Mg++ 2.2.	PVT	UNK	TOPROL extended release; NORVASZ; DIOVAN; Amiloride; LEXAPRO; Aspirin every day	None	High blood pressure . PMH:  HTN, A-fib, Sleep apnea-on CPAP. Kidney cancer-partial nephrectomy. Anxiety			1						1	Amnesia; Anorexia; Arthralgia; Deafness; Hypersomnia; Hypophagia; Laboratory test; Pain in extremity; Tooth infection; Tremor; Vomiting; Weight decreased	FLU3~SANOFI PASTEUR~U2754AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0336628	01/06/2009	NE	52.0	52		F	01/06/2009	Injection site hurt longer than any previous flu shot and muscle continues to hurt especially with movement of arm, with some restriction of movement and decreased use of arm due to pain.									N	11/11/2008	11/11/2008	0		OTH	PVT	OMEPRAZOLE; D allergy, SINGULAIR; CYMABALTA; calcium + D; multi-vitamin, Vitamin C; Vitamin E; Vitamin B complete	No	Asthma; environmental allergies; laryngeal reflux; depression	kidney failure~Vaccine not specified (no brand name)~UN~1.50~In Sibling		1						1	Injected limb mobility decreased; Injection site pain; Pain	FLU3~SANOFI PASTEUR~U2760AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336629	01/06/2009	WI	54.0	54		F	01/06/2009	Arm was sore for prolonged amount of time after receiving flu shot. Burning all the way down to the elbow for a few seconds, then ached for a month or more.									Y	10/24/2008	10/24/2008	0		PVT	UNK		no	no			1						1	Pain; Pain in extremity; Skin burning sensation	FLU3~SANOFI PASTEUR~U2786BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336630	01/06/2009	MN	22.0	22		M	01/06/2009	Arm was sore at site of injection for a prolonged amount of time immediately after injection.				Y					Y	10/24/2008	10/24/2008	0	CXR showed inflammation	PVT	UNK						1						1	Chest X-ray abnormal; Immediate post-injection reaction; Inflammation; Injection site pain	FLU3~SANOFI PASTEUR~U2786BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0336631	01/06/2009	MN	29.0	29		F	01/06/2009	Arm was sore after receiving flu shot for a prolonged amount of time joint pain-not relieved by Ibuprofen.				Y					Y	10/27/2008	10/27/2008	0	No	PVT	UNK		no	no			1						1	Arthralgia; Pain in extremity	FLU3~SANOFI PASTEUR~U2786BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0336632	01/06/2009	CA	69.0	69		M	01/06/2009	Bell's palsy-absence of muscular control of right facial muscles-upper, middle, lower face-Drooping eye and mouth.				Y					N	12/08/2008	12/11/2008	3	No lab data; MD performed - neurological tests to rule out other causes.	PUB	PUB	THYROXINE; Paroxetine	None	Hypothyroidism			1						1	Facial palsy; Facial paresis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~87924~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0336636	01/06/2009	MD	25.0	25		F	12/31/2008	12/11/08 6:00pm, Rash appeared on L arm and L side of face and chest.  Pt. also had local reaction of warmth and redness, described like the size of a fist Night of 12/11 pt. 's throat and L side of body itchy.  12/12/08 am, On awakening:  She discovered red raised rash all over body.  Pt took BENADRYL and saw MD.  Pt. received steroid injection.  MD instructed pt. to continue BENADRYL.				Y					Y	12/10/2008	12/11/2008	1	None	PUB	OTH	Birth control;  Vitamin B-12	No	None			1						1	Erythema; Local reaction; Pruritus; Rash erythematous; Rash generalised; Skin warm; Throat irritation	FLU3~SANOFI PASTEUR~U2805AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0336637	01/06/2009	NY	1.5	1	.5	M		Localized swelling (L) lateral thigh.										12/29/2008	12/29/2008	0		PVT	UNK		Fever				1						1	Injection site swelling	DTAP~SANOFI PASTEUR~U2471AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2831AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB262AA~1~IM~LL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~D05882~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0336619	01/07/2009		44.0	44		M	12/17/2008	Vaccine administrator (certified by Immunizations course) inadvertently provided a PPD utilizing the Anthrax vaccine .1cc intradermally.  Pt was not indicated to receive Anthrax (presented for PPD and Flumist) but had previous Anthrax vaccinations due to deployment.  PT advised immediately of the error.  No initial redness at site of inadvertent injection. Pt also received Flumist, PPD, and Anthrax additional by SC route per PT request. Pt will return within 48-72 hours for PPD reading (PPD was placed after incident in opposite arm) and will follow up at that time with Ambulatory care Clinic staff related to inadvertent Anthrax injection (Intradermal) to ensure there are no complications.  Head Nurse notified by immunization staff after encounter completed.  Head Nurse discussed incident with patient and advised to contact clinic if pain, redness, or swelling at site of injection occurs or Go to ER immediately if any acute issues occur. Contacted Dr, Immunizations Physician and advised of the incident.  He concurred with plan of care and advised there is a minimal likelihood of complications, other than local irritation to affected area, that may occur. Administrator provided patient with personal contact information for any questions, concerns, or issues.  2.  Patient was followed up by clinic providers on 16 DEC 2008, 17 DEC 2008, and 19 DEC 2008.  Provider visit on 19 DEC 2008 advised patient to return to clinic only as needed due to resolving redness and irritation.  Lab tests completed on 19 DEC 2008 were within normal range.  Specific medical documentation available in electronic record.  Administrator contacted on 30 DEC for verbal follow up.  Pt reported ½ dime size reddened area with a small nodule like a BB under skin.  Provider advised and no further medical action is needed at this time.  Continue to monitor and RTC if conditions worsen or return.				Y					Y	12/15/2008	12/15/2008	0	CBC/ CHem 7 / LFT (All retruned WNL)	MIL	MIL	None, Keflex added shortly after inadvertent Anthrax ID vaccination	none	none			1						1	Erythema; Full blood count normal; Incorrect route of drug administration; Laboratory test normal; Liver function test normal; Nodule; Skin irritation; Wrong drug administered	ANTH~EMERGENT BIOSOLUTIONS~FAV73~7+~SC~RA~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500561P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|UNK~UNKNOWN MANUFACTURER~C2910AA~UNK~ID~RA~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0336655	01/07/2009	CO	55.0	55		M	12/26/2008	Began with left elbow pain, progressed to right elbow, then to other joints. Peaked, with all over, achy body and high fever. Patient has been slowly getting better, according to patient on 12/23/2008.				Y					N	10/09/2008	10/16/2008	7	Patient stated that his doctors believe this to believe an autoimmune response to the vaccine.	OTH	PVT	Unknown	None	Unknown			1						1	Arthralgia; Autoimmune disorder; Pain; Pyrexia; Vaccination complication	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89986~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0336656	01/07/2009	MA	1.4	1	.4	F	01/02/2009	As part of flu clinic  17 mo was given FLUMIST approved for equal to or greater than 2 year olds.  No reactions.									U	11/06/2008				PUB	PUB	None	None	None			1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500569P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0336673	01/07/2009	NC	51.0	51		F	01/05/2009	Initial information was received on 20 October 2008 from a health care professional. A 51 year old female patient received an intramuscular injection of FLUZONE (lot number U2765AA) on 16 October 2008. On 17 October 2008 the patient complained of itching with welts on the palms of her hands, axillary area, back, upper trunk, and abdomen approximately 24 hours post vaccination. The patient self medicated with Benadryl and had some relief. the patient continued to take the Benadryl and the symptoms persisted. The patient was not recovered at the time of the report. Follow-up information received on 31 December 2008 from a health care professional. The patient had no past medical history, or use of other medications at the time of vaccination on 16 October 2008. The adverse events of welts and itching were treated with Solu-Medrol injection and Prednisone tapering dose pack. No final overall diagnosis was made. The patient fully recovered on 24 October 2008, which was seven days after onset of first symptoms. Per this new information, this case was upgraded to serious. List of Documents held by Sender: None.				Y					Y	10/16/2008	10/17/2008	1	None reported.	UNK	UNK			The patient had no past medical history or use of other medications.		200803258	1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2765A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0336675	01/07/2009	FL	6.0	6		M	12/31/2008	Some shots have given patient the not unexpected warmth and redness at the shot site. What is unusual is that he subsequently developed hyper pigmentation where the redness was that lingers for several weeks to months. Interesting he has had similar reactions to minor cellulitis.									U	12/11/2008				PVT	UNK						1						1	Condition aggravated; Injection site discolouration; Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U2802AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB8257AA~3~IM~RA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2813AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0336709	01/07/2009	PA	4.0	4		M	01/07/2009	1 day after vaccine administration, painful, red swelling of left upper arm									U	01/05/2009	01/06/2009	1	none	PVT	PUB	Albuterol MDI and Flovent MDI	none	asthma			1						1	Erythema; Oedema peripheral; Pain in extremity	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B087BA~4~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2847AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0996-2~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1209X~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1282X~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0336710	01/07/2009	FL	28.0	28		M	01/07/2009	PT SUFFERED FROM HIVES, RASHES AND A MILD GRADE FEVER FOR 7 DAYS FOLLOWING VACCINATION. THE PT RECEIVED TX WITH PREDNISONE AND RECOVERED WITHIN DAYS.				Y					Y	12/01/2007	12/02/2007	1	NONE	MIL	OTH	VALTREX, CLARITIN, AVAREX	NO ACUTE ILLNESS.	STEVEN-JOHNSON SYNDROME	DEVELOPED STEVEN-JOHNSON SYNDROME~Smallpox (no brand name)~UN~23.00~Patient		1						1	Pyrexia; Rash; Urticaria	FLU3~SANOFI PASTEUR~Z1102~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0336713	01/07/2009	CA	0.75	0	.7	F	01/07/2009	One day after receiving the first dose of the injectable flu vaccine, the patient developed red bumps. There were three larger bumps near the injection site and smaller bumps over the body. The baby was 'grumpy' for two days but no fever and no itching. The bumps disappeared in three days. The mother did not bring the baby to clinic for evaluation, thus all symptoms were reported by the mother.									Y	11/13/2008	11/14/2008	1		PUB	PUB	None	None	None			1						1	Injection site rash; Irritability; Rash erythematous	FLU3~SANOFI PASTEUR~UT2783GA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336723	01/07/2009	MN	40.0	40		F	01/06/2009	Arm was sore after receiving flu shot for a prolonged amount of time initially felt burning 3 weeks following. Arm was painful and hard to lift.				Y					Y	10/24/2008	10/24/2008	0	Had CXR	PVT	UNK		no	no			1						1	Burning sensation; Chest X-ray; Mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2786BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0336724	01/07/2009	IA	40.0	40		F	12/03/2008	Initial information was received on 02 December 2008 from a health care professional.  A 40 year old female patient with a nut allergy received an intramuscular right deltoid injection of FLUZONE No preservative 2008-2009 (lot number UT2758AA) on 20 November 2008.  On 24 November 2008 the patient called her physician to report she had pain at the injection site.  She took IBUPROFEN without relief.  On 26 November 2008 she was seen by her physician.  The physician stated that nothing appeared to be at the site.  The patient was prescribed VOLTAREN.  The patient continued to have pain at the time of the report.  No other symptoms were reported.  The recovery status was not provided.  List of Documents held by Sender:  None.				Y					N	11/20/2008	11/24/2008	4	None reported.	PVT	PVT	Multivitamin	None	The patient had a nut allergy.		200803861	1						1	Injection site pain	FLU3~SANOFI PASTEUR~UT2785A~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0336727	01/07/2009	CA	1.0	1	.0	M	01/07/2009	Mild varicella-like rash - Rt upper arm 3 clustered vesicles erupting 1 wk ago, now crusted and 2 1-2 mm erythematous papules on ant. chest.  + URI Sx, no fever.									Y	12/19/2008	01/01/2009	13	None	OTH	PUB	None	None	None			1						1	Blister; Rash erythematous; Rash papular; Rash vesicular; Scab; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~UT2794EA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB319AA~1~UN~LA~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0890X~1~UN~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C8314B~4~UN~RA~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0790X~1~UN~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0336728	01/07/2009	CA	4.0	4		F	01/06/2009	Local reaction with itching, redness, and swelling on right thigh at the site of Flu vaccine.									Y	12/19/2008	12/20/2008	1		PVT	UNK						1						1	Erythema; Local reaction; Pruritus; Swelling	FLU3~SANOFI PASTEUR~U2751AA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A04914~4~UN~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1370X~2~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0336101	01/08/2009	OH	7.0	7		F	12/19/2008	Next morning arm swollen, red and hard very tender.									Y	11/22/2008	11/23/2008	1		PVT	PVT	None	None	None			1						2	Erythema; Induration; Oedema peripheral; Tenderness	FLU3~SANOFI PASTEUR~U2770AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|VARCEL~MERCK & CO. INC.~1194X~2~UN~UN~VARICELLA (VARIVAX)~2	USA		Influenza
0336783	01/08/2009	CA	78.0	78		F		On Oct. 27th Monday:  Nurse at medical center gave me Pneumonia shot on Right shoulder. The shot was high on the shoulder and it pricked the Bone.  Oct 29th went to Dr and complained about the shot.  My arm is paralyzed!! Dr. said take ASPIRIN and it will get better.  It has been over 2 mo.  It still not better.  3/16/09 Received PCP medical records of 10/29/08-1/6/2009. FINAL DX: right shoulder impingement syndrome; left frozen shoulder Records reveal patient received Pneumo #3 & Flu #12 vaccines on  10/25/2008 but no lot #s or sites provided.  RTC 11/12 w/frozen left shoulder since 8/08 w/decreased strength & ROM.  Tx w/PT.  RTC 1/6/09 w/right neck & shoulder pain since flu shot.  Dx w/right shoulder impingement syndrome, neck muscle spasm, insomnia.  Referred to Ortho & PT.				Y					N	10/27/2008	10/27/2008	0		PVT	UNK		Month B-4 Have a pace maker installed	None  PMH: DM2, hyperlipdemia, obesity, anxiety, angina pectoris, gastritis, OA, platar fasciitis, SSS s/p pacemaker placement 5/08 & revised 6/08, HTN.			1						1	Wrong technique in drug usage process	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0336785	01/08/2009	IL	1.0	1	.0	M	01/07/2009	Patient seen on 12/18/08, received immunizations, had low grade fever next day and then was brought to ER lifeless. 2/17/09-records received COB bacterial sepsis. Other significant conditions contributing to death but not related to terminal conditions:sickle cell anemia trait. krk	Y	12/19/2008							N	12/18/2008	12/19/2008	1		PUB	PUB	None	None, healthy	Extra digit both hands at birth - tied; H/O drugs use in, child was in D 2/17/09-records received-sickle cell anemia trait			1						1	Death; Pyrexia	FLU3~SANOFI PASTEUR~UT2792CA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB319AB~1~UN~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1083X~1~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1317X~1~UN~LL~VARICELLA (VARIVAX)~1	USA	Results in Death	Influenza
0336786	01/08/2009	SC	5.0	5		M	01/08/2009	Diagnosed with juvenile onset diabetes mellitus 17 days after live flu vaccine. 1/12/09-records received for DOS 12/14-12/15/08-DC DX: New onset diabetes mellitus. presented with C/O increased thirst, urination, sugar high.  02/01/2010 The original event reported was a temporal associatioon of the FluMist and developent of Juvenile diabetes.			Y		Y	1		Y	N	11/28/2008	12/14/2008	16	1/12/09-records received- Glucose 486. Glucose urine 4+.	PVT	PUB	None		Had neonatal hepatitis at 7 wks, recovered, born at 36 wks 1/12/09-records received-Family history, twin sister with DM since age of 2.			1						1	Diabetes mellitus; Pollakiuria; Type 1 diabetes mellitus	FLUN3~MEDIMMUNE VACCINES, INC.~500561P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0336788	01/08/2009	PA	63.0	63		F	12/31/2008	10/17/08 3:30 am Hives hospital ER. (10/18/08 9:22 am city hospital ER cover in hives- extreme itching-skin turning black and blue from top to bottom. BP 206/148). $ 585.81				Y					Y	10/15/2008	10/16/2008	1		PVT	PVT						1						1	Hypertension; Pruritus; Skin discolouration; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA185AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0336789	01/08/2009	PA	38.0	38		M	01/05/2009	10/22/08 - 8pm- Body aches, fever/chills, post nasal drip, sore throat.  Evening of 10/23/08, had increased sinus congestion, body aches, fever/chills and unable to sleep.  10/24 AM, saw Dr.  for viral infection and sinus infection.  Given Zithromax.   Relieved of fever & chills.				Y					Y	10/20/2008	10/22/2008	2	None	OTH	PUB	None	None	Allergic to cats and dust			1						1	Chills; Insomnia; Oropharyngeal pain; Pain; Postnasal drip; Pyrexia; Sinus congestion; Sinusitis; Viral infection	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88805~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0336790	01/08/2009	AZ	18.0	18		M	12/30/2008	Patient administered  flu vaccine; patient began to faint (vasovagal episode) occurred; vital signs taken.									Y	12/30/2008	12/30/2008	0		MIL	MIL						1						1	Syncope; Syncope vasovagal	FLU3~SANOFI PASTEUR~U2833AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336791	01/08/2009	PA	6.0	6		F	01/07/2009	Local redness & swelling - started - by 4-5 pm on 1-5-09 - gotten progressively worse & longer. > 50 cent. noted at office visit 1-7-09 445pm.									U	01/05/2009	01/05/2009	0		PVT	PVT		None	None			1						1	Erythema; Local reaction; Swelling	FLU3~SANOFI PASTEUR~U2791AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB320BA~1~IM~UN~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1365X~2~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1153X~2~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0336825	01/08/2009	NY	16.0	16		F	01/08/2009	after the vacc,pt c/o dizzyness,when seen pt looked pale and sweaty,pulse 55,bp 88/54,pt put on table at trendlenberg position felt better ,bp 99/69,pulse 82									Y	01/07/2009	01/07/2009	0		PUB	PUB						1						1	Blood pressure decreased; Dizziness; Heart rate decreased; Hyperhidrosis; Pallor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89623~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HPV4~MERCK & CO. INC.~0928u~3~IM~RA~HPV (GARDASIL)~1	USA		Influenza
0336826	01/08/2009	CA	2.0	2	.9	M	01/08/2009	Flumist was administered at 11:00am on Monday.  By 10:00pm Tuesday evening patient has an extremely running nose, coughing, low fever ~100, severe sore throat, and headache.										01/05/2009	01/06/2009	1		UNK	UNK		None	None			1						1	Cough; Headache; Oropharyngeal pain; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0336827	01/08/2009	DC	0.75	0	.8	F	01/08/2009	Hives, starting 1 day after shot.  Strong family history of allergy to flu shot, in mother and brother.									Y	01/06/2009	01/07/2009	1		PUB	UNK	None at time	Constipation	Constipation			1						1	Urticaria	FLU3~SANOFI PASTEUR~UT2788FA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336830	01/08/2009	IA	68.0	68		F	01/08/2009	Patient experienced acute leg weakness progressing to include arm weakness and overall body weakness within a two-week period. Saw family physician on 12/8/08. Extensive lab testing was completed with normal results. Had follow-up visit with family physician who then referred patient to neurologist. Diagnosed by neurologist on 1/5/09 with Guillain-Barre. Patient still experiencing weakness and fatigue.  1/23/2009 MR received from Neurologist for DOS 1/5/2009 with DX: Acute Demyelinating Immune Polyneuropathy (Guillain-Barre syndrome). Appears to be a mild case already improving.  Possibly r/t Flu shot although not certain.  Pt presented for eval of weakness which developed in mid November 2008. Pt's legs felt rubbery and gait was abnormal. No muscle pain or sensory loss. Remained stable x 1 month, now improving x 2 weeks. More easily fatigued.  PE (+) for slight waddling type gait, decreased strength (3/5) of the interossei upper and 4/5 lower extremities, absent tendon reflexes. No tx since pt was improving w/o tx.				Y					N	11/04/2008	11/18/2008	14	Monoscreen: negative, CRP & thyroid screen: within normal limits.	UNK	UNK	Lisinopril/HCTZ 10/12.5 mg, Zetia 10 mg (discontinued 12/8), Amitriptyline 75 mg, Fioricet (prn only), Darvocet N-100 (prn only)	None.	Allergies: codeine, Medical conditions: hypertension, hypercholesterolemia. PMH: Allergy to codeine.  HTN, Depression, Hyperlipidemia			1						1	Asthenia; C-reactive protein normal; Fatigue; Guillain-Barre syndrome; Mononucleosis heterophile test negative; Muscular weakness; Thyroid function test normal	FLU3~SANOFI PASTEUR~U2791EA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0336832	01/08/2009	TX	23.0	22		F	01/08/2009	23 year old female presented to Student Health Center at TAMU on 11/25/08 with complaint of right arm pain ever since she got her flu shot in mid october 2008. It hurts to lift her arm and it is tender to touch. She wakes up when she lies on it during the night.									U	10/15/2008	10/15/2008	0	None done yet.	UNK	UNK	Ortho Tri-Cyclen Lo oral contraceptives.	No.	None.			1						1	Pain in extremity; Sleep disorder; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0336835	01/08/2009	MN	5.0	5		F	01/08/2009	Received the shots on 10/23/2008 at 19:45 pm.  After 24 hours developed itching and swelling of the forearm that extended to the entire arm. The are also became warm after 48 hrs. The swelling subsided after two weeks. She was only given Ibuprofen syrup				Y					Y	10/23/2008	10/24/2008	1		PUB	PUB		None	She is allergic to Amoxcillin but she outgrew it	None~ ()~NULL~~In Patient|None~ ()~NULL~~In Sibling1		1						1	Oedema peripheral; Pruritus; Skin warm	FLU3~SANOFI PASTEUR~U2797BA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0336838	01/08/2009	CT	64.0	64		F	01/08/2009	GUILLIAN BARRE Syndrome after receiving the flu shot.  Very severe case, currently in intensive care at Hospital 2/25/09-records received for DOS 1/5-2/9/09-DC DX:Central Nervous System Vasculopoathy due to Primary versus Secondary Central Nervous System Vasculitis. Bilateral parietoccipital ischemic strokes. GUILLIAN-BARRE syndrome MILLDER FISHER variant.  Presented with uncontrollable back pain and body aches, general malaise, nausea and vomiting.PE: Gait instability, ataxia, dysmetria. Altered mental status and hypertensive crisis and autonomic instability. Patellar reflexes absent, mild left facial palsy. IVIG treatment. Mechanical ventilation and intubation with tracheostomy.  2/25/09 Hospital records, DC summary received. Service dates 1/5/09 too 2/9/09. Assessment:  Principle Diagnosis - Central Nervous System Vasculopathy due to Primary vs Secondary Central Nervous System Vasculitis. Other Diagnoses - Bilateral Parietooccipial Ischemic Strokes, Guillain-Barre Syndrome, Coronary Artery Disease, Hyperlipidemia, Hypothyroidism, Depression.  Viral gastroenteritis with abdominal discomfort and diarrhea 2 weeks prior. Patient presented with uncontrollable back pain and body aches. General malaise, nausea and vomiting. Difficulty with balance. Gait instability, ataxia, dysmetria. Altered mental status, hypertensive crisis, admitted to ICU. Patellar reflexes initially present, later patellar and Achilles reflexes absent. 1+ reflexes biceps / triceps.  Mild left facial palsy. IVIG administration. Mental status worsened. Acute bilateral strokes. Babinski present. Right thigh hematoma. Mechanical ventilation. Gastrostomy tube. Aspiration pneumonia. Follow-up: Serious vision impairment Started with flu-like symptoms about a week or two after receiving shot. Seemed to recover but still weak, stomach pain. Jan 1, 2009 - intense stomach pain, nausea, weakness, inability to walk, shoulder and back pain, dizziness. Admitted to hospital Jan 5, 2009. Flu vaccine 10/31/08, possibly also shingles vaccine.			Y	Y	Y	34	Y		N	10/31/2008	01/01/2009	62	2/25/09-records received- Lumbar puncture elevated protein 76, normal glucose 77, 29 red blood cells, 75,000 white blood cells, no oligoclonal bands, IgG normal, no PCRss detected. ANA titer normal, negative anti-Rho antibody, ESR 8. Rheumatoid factor elevated at 48.MRI brain T2 abnormality in white matter and subsequent MRIs demonstrated stable extensive areas of restricted effusion within bilateral parietocciptal regions.. CTA vessel irregularity. EKG sinus tachycardia. Troponin increased 0.11. Liver function tests elevated. Elevated WBC 13, urine culture negative, blood culture positive for coag-negative Staphylcoccus. Chest x-ray consistent with aspiration pneumonia.   LABS and DIAGNOSTICS:   CBC - WBC 11.0 x1000/uL (H) Neutophils 85% (H) Lymphocytes 8% (L).   Urinalysis - Protein 2+, Glucose 1+, Ketones small, blood small, WBC 2-5, RBC 6-10, Bacteria few, Epithelial cells few, Mucus moderate.   CSF - RBC 7500 /ul (H) Protein 76 mg/dL (H) Albumin 46.0 mg/dL (H) Ig.G 6.8 mg/dL (H).  CHEM - Glucose 182 mg/dL (H) Chloride 93 mmol/L (L) Sodium 129 mmol/L (L) Bilirubin Direct 0.26 mg/dL (H) Bilirubin Total 1.26 mg/dL (H) Cortisol 40 ug/dL (H)   Rheumatoid Factor 48 IU/mL (H). CT Head - Abnormal. CTA Neck - Abnormal. MRI Brain - Abnormal. EKG - Abnormal, sinus tachycardia. Blood culture (+) for coag-negative Staphylococcus.  EBV-VCA Antibody IgG (+) EBV-EBNA Antibody (+).  Will provide more information and vaccine data	OTH	OTH		none 2/25/09-records received- Viral gastroenteritis with abdominal discomfort and diarrhea approximately 2 weeks prior to admission on 1/3/09.	2/25/09-records received-PMH:Coronary artery disease. hyperlipidemia, hypothyroidism, depression. Slight elevated c reactive protein, hypothyroid, hypotension, poss rheumatoid arthritis and coronary artery disease - being treated successfully by cardiologist.			1						1	Angiopathy; Blood albumin increased; Cerebrovascular accident; Computerised tomogram head; Guillain-Barre syndrome; Intensive care; Urine analysis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89973~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0336843	01/08/2009	VA	66.0	66		F	01/07/2009	Numbness of upper lip < lower lip as well a little swelling. Sinus area feel dry, rash developed on legs, arms, and face. Swelling of lower eye lids.				Y					Y	01/07/2009	01/07/2009	0		OTH	OTH	Benzoate 200 mg, Paxil CR 25mg, Nasonex, Lotrel, HCTZ 25mg	None	Penicillin, codeine, high blood pressure			1						1	Eyelid oedema; Hypoaesthesia oral; Lip swelling; Rash; Sinus disorder	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0336845	01/08/2009	NM	82.0	82		F	01/08/2009	Cellulitis to RUE to include erythema and edema 15cmx9cm. Warm to touch and pain. SXS started last night. Pt tx'd IV Abx and PO Abx.									U	01/07/2009	01/07/2009	0		PVT	PVT	HCTZ; Verapamil; Bupropion HRT	Appt for nevi	HTN; Hypothyroidism; Depression			1						1	Injection site cellulitis; Injection site erythema; Injection site oedema; Injection site pain; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89994~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0336847	01/08/2009	NY	74.0	74		F	01/07/2009	Pain & redness - Left deltoid - pt. did not use ice or take analgesic.  She decided not to wait for Dr. - he was seeing in-pts @ hospital.  Advised to use ice on arm & return if still red & painful.									U	01/06/2009	01/07/2009	1		PVT	UNK						1						1	Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U2760AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0981X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0336854	01/08/2009	NY	16.0	16		F	01/07/2009	Information has been received from a consumer concerning her 16 year old daughter with no medical history or drug allergies who on 06-DEC-2008 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. Within 24 hours after vaccination the patient started experiencing pain and within 2 days she started vomiting. She was admitted to a hospital on 12-DEC-2008 (enzyme levels were over 800) and released on the 16th. The hospital determined it was pancreatitis. Multiple tests were performed in the hospital including CAT scan and ultrasound but the results were not provided. The patient was not fully recovered yet, however her mother stated that she was better and her enzyme levels were coming back to normal. Additional information has been requested.  3/16/09 Received PCP medical records of 7/31/08-2/13/2009. FINAL DX: acute on chronic pancreatitis w/strictures & pancreatic stones s/p stent placement; pancreas divisum; asymptomatic until 12/10/08. Records reveal patient experienced good health on 12/6/08 when received HPV #1 & flu shot.  RTC 12/10/08 w/cough, cold s/s & chest/upper abdomen pain near diaphragm.  Dx w/muscle strain & URI.  RTC 12/12 w/continued upper abdominal pain w/vomiting, watery diarrhea, pale w/decreased bowel sounds, guarding & rebound.  Sent to hospital for acute abdomen.  RTC 12/17 s/p hospitalization w/resolving pancreatitis.    4/16/09 Received hospital medical records of 12/12-12/15/2008. FINAL DX: pancreatitis, etiology unknown Records reveal patient experienced progressively worsening epigastric pain x 5 days, N/V x 1 day.  Seen by PCP & dx w/musculoskeletal pain.  Continued to worsen &unable to walk or attend school.  ALso had cold s/s during the week & multiple sick contacts. Surgery & GI consult done. Labs & PE improved & able to tolerate diet.  D/C to home W/PCP & GI f/u.				Y	Y	4			N	12/06/2008	12/07/2008	1	Diagnostic laboratory, 12/12/08, enzyme levels over 800  LABS: CT scan & US abdomen abnormal w/pancreatic & common bile duct dilation & calcification of pancreatic head.  MRI/MRCP abnormal w/dorsal duct syndrome, pancreatic stones & strictures.  EGD w/endoscopic US abnormal & c/w mod-severe chronic pancreatitis.    Amylase 716, lipase 812(both H). ESR 75(H), CRP 5.1(H).  CT abdomen abnormal w/pancreatic & CBD dilatation; calcification in pancreatic head c/w chronic pancreatitis; & peripancreatic edema.  US abdomen abnormal.	OTH	OTH	None		None  PMH:  Foreign travel 7/08.  Family hx: IBS.		WAES0901USA00056	1						1	Enzyme abnormality; Vomiting	FLU3~SANOFI PASTEUR~U2853AB~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0652X~1~IM~UN~HPV (GARDASIL)~1	USA	Hospitalisation	Influenza
0333459	01/09/2009	NC	7.0	7		M	01/05/2009	Knot on Rt. Arm c/o hurting									Y	11/18/2008	11/20/2008	2		PVT	PUB						1						2	Induration; Pain in extremity	FLU3~SANOFI PASTEUR~U27950A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0336865	01/09/2009	OR	2.0	2	.5	F	01/05/2009	Prolonged soreness/pain complaints from site of injection diminishing over time but lasting 5 weeks. Complaints finally subsided 12/31/09.									Y	11/24/2008	11/25/2008	1	None	UNK	UNK		None				1						1	Injection site pain	FLU3~SANOFI PASTEUR~UT2785CA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB260AA~2~IM~RL~HEP A (HAVRIX)~1	USA		Influenza
0336866	01/09/2009	FL	8.0	8		M	12/31/2008	Mother states child developed swelling to the left deltoid area approximately 8-12 hours after receiving flu vaccine. Also he complained of itching at the site and itching to his tongue. Mother states that both cold and hot compresses were applied as well as vicks vapor rub. Violet was applied to the tongue by mother. Child returned to Health Center after 24 hours was examined and instructed to use cool compresses only and to give 1 TSP Benadryl every 6 hours as needed.				Y					Y	12/30/2008	12/30/2008	0		OTH	PUB	None	None	None			1						1	Injection site pruritus; Injection site swelling; Paraesthesia oral; Pruritus	FLU3~SANOFI PASTEUR~U2800EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0336871	01/09/2009	MA	38.0	38		M	01/04/2009	Pt presented with redness on his torso and reported having a fever the night after receiving influenza vaccine.  Pt referred to primary care provider.									Y	01/03/2009	01/03/2009	0		MIL	UNK		No	No			1						1	Erythema; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0336872	01/09/2009	WI	15.0	15		F	12/19/2008	Rec'd varicella and FLUZONE R arm 12/15/2008.  Mother reports today an area  3x4, that is warm, red, hard and rashy at the injection site R arm.				Y					U	12/15/2008	12/18/2008	3		PUB	PUB	None	None	None			1						1	Injection site erythema; Injection site induration; Injection site rash; Injection site warmth	FLU3~SANOFI PASTEUR~U2848AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0652X~1~IM~LA~HPV (GARDASIL)~1|VARCEL~MERCK & CO. INC.~0177X~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0336877	01/09/2009	PA	50.0	50		F	01/02/2009	Patient had right deltoid IM injection of PNEUMOVAX and since then had local reaction, large, of pain, edema, a erythema slowly improving.				Y					U	12/30/2008	12/30/2008	0	None	PVT	PVT	BUSPAR; ASMAVET; PATENOL	No	GERD; allergies; central serous retinopathy			1						1	Erythema; Local reaction; Oedema; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~90000~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1163X~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0336913	01/09/2009	DC	28.0	28		M	01/09/2009	SM RECEIVED THE INFLUENZA INTRAMUSCARLY VACCINE VIA INTRANASAL ROUTE									Y	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336915	01/09/2009	OH	31.0	31		F	01/09/2009	Had been sick the week before vaccine with a 'virus'. Day of vaccine was feeling ok, day following vaccine (11/21/08) thought she had burner her tongue and could not taste. 11/22/08 developed headache and ear ache.  11/24/08 had headache behind eye and low grade temp.  11/25/08 eye felt swollen, later lips not working, taste off, rt. side slightly drooping - went to ER.				Y					Y	11/20/2008	11/21/2008	1		PUB	PVT	Insulin	One week before - had a 'virus'	IDDM		1005	1						1	Ageusia; Body temperature increased; Ear pain; Eye swelling; Facial palsy; Headache; Paraesthesia oral	FLU3~SANOFI PASTEUR~U2832AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0336916	01/09/2009	DC	49.0	49		F	01/09/2009	SM RECEIVED THE INFLUENZA INTRAMUSCARLY VACCINE VIA INTRANASAL ROUTE									Y	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336917	01/09/2009	DC	27.0	27		M	01/09/2009	SM RECEIVED THE INFLUENZA INTRAMUSCARLY VACCINE VIA INTRANASAL ROUTE									Y	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336918	01/09/2009	DC	45.0	45		F	01/09/2009	SM RECEIVED THE INFLUENZA INTRAMUSCARLY VACCINE VIA INTRANASAL ROUTE									Y	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336919	01/09/2009	DC	23.0	23		F	01/09/2009	SM RECEIVED THE INFLUENZA INTRAMUSCARLY VACCINE VIA INTRANASAL ROUTE									Y	11/16/2008				UNK	UNK						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336920	01/09/2009	DC	36.0	36		M	01/09/2009	SM RECEIVED THE INFLUENZA INTRAMUSCARLY VACCINE VIA INTRANASAL ROUTE									Y	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336921	01/09/2009	DC	27.0	27		M	01/09/2009	SM RECEIVED THE INFLUENZA INTRAMUSCARLY VACCINE VIA INTRANASAL ROUTE									Y	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336922	01/09/2009	DC	29.0	29		M	01/09/2009	SM RECEIVED THE INFLUENZA INTRAMUSCARLY VACCINE VIA INTRANASAL ROUTE									Y	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336923	01/09/2009	DC	43.0	41		M	01/09/2009	SM RECEIVED THE INFLUENZA INTRAMUSCARLY VACCINE VIA INTRANASAL ROUTE									Y	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336924	01/09/2009	DC	42.0	41		M	01/09/2009	RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE									Y	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336925	01/09/2009	DC	29.0	29		M	01/09/2009	SM RECEIVED THE INFLUENZA INTRAMUSCARLY VACCINE VIA INTRANASAL ROUTE									Y	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336926	01/09/2009	DC	38.0	38		M	01/09/2009	SM RECEIVED THE INFLUENZA INTRAMUSCARLY VACCINE VIA INTRANASAL ROUTE									Y	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336927	01/09/2009	DC	37.0	37		M	01/09/2009	SM RECEIVED THE INFLUENZA INTRAMUSCARLY VACCINE VIA INTRANSASAL ROUTE									Y	11/16/2008				MIL	MIL						1						1	Incorrect route of drug administration	FLU3~CSL LIMITED~03149111A~UNK~IN~NS~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0336929	01/09/2009	WA	32.0	32		M	01/09/2009	Patient recieved Flumist (lot 500570P) intranasal 13Nov08 as part of his vaccination program.  He developed vague lower back pain approx 10Dec08, sought care 16Dec08, and over next several days had progressive neurologic deficits.  This lead to evaluations on 23 and 24Dec08, with admission to hospital, rapid deterioration, and ICU admission-intubation due to respiratory compromise due to neurologic impairment 26Dec08.  The patient is currently in the ICU with a diagnosis of multilevel (C-2 to T-10) transverse myelitis of unclear etiology.  He is on the ventilator for respiratory support, and has severe neurologic deficits corresponding to the levels of his myelitis.  Due to the proximity of his Flumist vaccine a VAERS report is being filed.  The treatment team recognizes that this vaccine is unlikely to be the causal agent and continues to actively pursue other causes and treatments.			Y	Y	Y	17	Y	Y	U	11/13/2008	12/11/2008	28	Numerous laboratory, radiologic and other tests of patient, as he continues to be in very serious condition in our ICU.	UNK	UNK	None at time of vaccination.  Several since this time related to ongoing medical condition.	None	None	none~ ()~~0.00~Patient|none~ ()~~0.00~Sibling|none~ ()~~0.00~Sibling		1						1	Back pain; Laboratory test; Mechanical ventilation; Myelitis transverse; Neurological symptom; Respiratory distress	FLUN3~MEDIMMUNE VACCINES, INC.~500570P~5~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0336931	01/09/2009	UT	49.0	49		F	01/09/2009	1) 5 min after injection, heat flush & abd cramping. 2) 10 min after, itching & heat @ injection site. 3) 15 min after, itching & hives over entire arm/shoulder area. 50mg Benadryl given. 4) 25-30 min after, heat flush, diaphoretic taken next door to urgent care. 5) 45 min after, diaphoretic, shortness of breath, spasms in throat. Epi dose of 0.3mg given. Ambulance called to urgent care. 6) ER - O2 100% NRB face mask, patient doesn't remember other treatments except stated she was given ativan.  She was in the hospital for 3 days.  After discharge, saw primary care physician for severe arm pain & swelling.  Ultrasound showed DVT in arm from infiltrated IV. Currently on Coumadin for 6 months.  Primary physician will have to strip vein. Released for return to work on 10/31/08.  2/10/2009 MR received for DOS 10/10-12/2008 with D/C DX:  Anaphylactic Reaction to Flu vaccine.  Mild metabolic acidosis.  Tachycardia. Pt presented to ER following receipt of Flu shot and immediate flushing, hives, diaphoresis, abdominal pain and H/A. Received Benadryl, Solumedrol and epi prior to arrival with poor response. Becam tachycardic, hypertensive and anxious en route to hospital. Upon arrival pt still c/o of throat closing and difficulty breathing. BP 212/69. PE WNL. Admitted for further med mgmt.				Y	Y	3			Y	10/10/2008	10/10/2008	0	Arterial Blood Gas / Chest XRay (findings unknown). Labs and Diagnostics: CXR WNL. CK 46 WNL. CKMB 1.9. Lactate (H) 2.5.	UNK	UNK	None	None	None. PMH:  C4-C5 fusion. hiatal hernia repair. NKDA.			1						1	Abdominal pain; Chest X-ray; Deep vein thrombosis; Dyspnoea; Flushing; Hyperhidrosis; Immediate post-injection reaction; Injection site pruritus; Injection site warmth; Oedema peripheral; Pain in extremity; Pruritus; Throat tightness; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89975~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0336942	01/09/2009	AR	24.0	24		F	01/09/2009	COMPLAINING OF PAIN AND TENDERNESS SINCE INJECTION, PAINFUL TO RAISE ARM OR LAY ON ARM.STATES ARM WAS SWOLLEN AND RED AFTER INJECTION FOR AND CONTINUES OFF AND ON TIL NOW.  USES TOPICAL RUB FOR DISCOMFORT.									U	12/11/2008	12/11/2008	0		PUB	PUB	TYLENOL AS NEEDED	NONE	NONE			1						1	Allodynia; Erythema; Oedema peripheral; Pain; Tenderness	FLU3~SANOFI PASTEUR~U2790BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0336943	01/09/2009	AR	47.0	47		M	01/09/2009	Patient received vaccine on 12/18/08.  Contacted telephone helpline 12/19/08 to report arm is swollen, red, warm to the touch; temp was 98.  Patient presented to ER on 12/20/08 with reports of worsened symptoms in addition to diarrhea, swelling and erythema at site of injection.  Initiated antibiotics for diagnosis of cellulitis.				Y					Y	12/18/2008	12/19/2008	1		MIL	MIL	gabapentin, omeprazole, oxycodone, rosuvastatin, docusate	see above	prostatitis, chronic neck pain, hyperlipidemia			1						1	Cellulitis; Diarrhoea; Erythema; Injection site erythema; Injection site swelling; Oedema peripheral; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA174AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1124X~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0336944	01/09/2009	TX	5.0	5		F	01/09/2009	Per mom C/O at about 5 - 6 PM started with chills and fever, highest temp 102.9, and headache. In morning noticed both arms red (from top of hands up to elbows). DX by Dr on 1/08/09 in office with Lymphangectasia and referred to Immunologist. Appt pending.									Y	01/06/2009	01/06/2009	0	Pending Immunologist appt.	UNK	UNK	none	none	04/07 milk allergy, 10/08 GERD	N/A~ ()~~0.00~In Patient|N/A~ ()~~0.00~In Sibling		1						1	Body temperature increased; Chills; Headache; Lymphadenopathy; Lymphangioma; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881171~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0336973	01/09/2009	IN	1.1	1	.1	F	01/09/2009	Rash over body started 1/8/09, worsened 1/9/09. Fever.									U	12/30/2008	01/08/2009	9	None	PVT	PUB	AMOXIL	Otitis	None			1						1	Pyrexia; Rash generalised	FLU3~SANOFI PASTEUR~U2739AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0006468100~1~IM~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C68311~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0006482700~1~IM~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0336979	01/09/2009	OR	18.0	18		M	01/09/2009	Mini stroke. 2/18/09 Neurology consult received dated 1/15/09 with no definite dx: Impression:  Transient word finding difficulties (dysphasia) with R hand numbness.  Raises concern for L hemisphere event, most likely vascular. Pt seen for consult for above sx.  Some loss of peripheral vision, a wierd feeling in legs lasting <1hr.  The following morning pt developed vertigo with N/V. PE WNL.  2/20/2009 2 ER records received for 1/8/09 with DX: Paresthesias, dysarthria, now resolved and 1/9/09 with DX:  Acute N&V, now resolved. Pt presented with sudden onset of paresthesias of the R arm and face and speech problems-talking and making no sense.  Resolved in 1 hr. Recent increase in neck pain following past accident. PE WNL. Started on ASA to f/u with neuro as outpt.  Returned the next day with nausea and 4-5 episodes of vomiting w/in 2 minutes which quickly resolved. Some tingling now in L arm. D/C to f/u as above.				Y					U	12/29/2008	01/08/2009	10	Labs and Diagnostics:  CT brain scan WNL except evidence of old C6 cervical fx. CTA WNL. MRI (+) for mild paranasal sinus disease, otherwise WNL.	PVT	PVT	Epi-Pen, 2 pak,0.3mg1; Albuterol 90mcg/inh 2 puff(s), QID prn; FLOVENT, HFA, CFC free, 110mcg/inh 1 puff(s) BID; SUDOGEST, 60mg, 1tab(s) Q6H; PREDNISONE, 20mg,1 tab(s), once a day	None	Eczema in childhood; wrist fracture, 12/04; allergic rhinitis, with reactive airway disease; allergies, nuts, oral reaction. PMH: chronic neck pain s/p snowboarding accident.  LOC after baseball strike to R eye. Wisdom teeth extraction.			1						1	Cerebrovascular accident; Aphasia; Computerised tomogram; Electrocardiogram; Hypoaesthesia; Laboratory test; Nuclear magnetic resonance imaging; Paraesthesia; Vomiting	FLU3~SANOFI PASTEUR~U2745AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2656AA~UNK~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|MNQ~SANOFI PASTEUR~U2656A~1~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~2	USA	Emergency room visit	Influenza
0336950	01/11/2009	NH	3.0	3		M	01/11/2009	Vomiting and fever. Had Vaccine mid-afternoon on the 10th. Had a fever that evening and through the night. Early morning complained of stomach ache and then got up at 8 am and vomited. Still has a fever.				Y					U	01/10/2009	01/10/2009	0		UNK	UNK	none	none	none	fever~Influenza (Seasonal) (no brand name)~UN~2.00~Patient		1						1	Abdominal pain upper; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2853AB~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0336951	01/11/2009	NE	28.0	28		F	01/11/2009	Erroneously received two doses of Meningococcal vaccine									Y	01/10/2009			None	MIL	MIL	None	None	Seasonal allergies			1						1	Inappropriate schedule of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|MNQ~SANOFI PASTEUR~U2823AA~3~SC~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2965AA~3~IM~RA~TDAP (ADACEL)~1|TYP~SANOFI PASTEUR~A0394~5~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0336952	01/11/2009	MN	42.0	42		F	01/11/2009	Fever (<100dF), which lasted several months.  Cough, which lasted a couple months.  Head cold, too.  (Treatment was with three sequential and different courses of anti-biotics.)				Y					Y	10/09/2008	10/09/2008	0	Yes.  Received 2008 flu vaccine at Hospital in.  You can find manufacturer/lot there. (Previously have received flu vaccines most years, since college.  Occasionally, have extremely mild cold symptoms -for a couple days- after vaccine.  Not a big deal.  This year, very very different.)  Ran a low-grade fever (<100dF) for *months*, much of the rest of 2008, with cough and cold.  Treated in 2008 initially at Dr office.  Note, tests do not show influenza.  Met woman recently who also said this years' vaccine gave her a high fever/cold.  Many in my extended family in were treated, after I was.  Recently, heard news report the 2008 vaccine was ineffective.  While I have never reported post-vaccine issues, I beg to differ.  (It is an understatement; the vaccine is not simply ineffective, as my experience is the 2008 vaccine may be quite effective at spreading fever and cold this year.)  Yes, I understand material in vaccine is dead and surely unrelated to any fever/cough/cold, and one can never get combined bacteria-virus colds from any flu vaccine (in some alleged lateral-gene transfer while vaccine incubates nor afterwards.)  I still believe in getting flu shots, but you folks may want to think through and investigate what and *how* you know for sure whatever it is that you think you know about vaccines.	UNK	UNK	None.	None known.	Allergic to the erythromycin family of anti-biotics.  Recently, dental shots which contain epinephrine.  Avelox. Plus, dust, dust mites, and one type of grass.			1						1	Cough; Nasopharyngitis; Pyrexia	FLUX~UNKNOWN MANUFACTURER~Unknown~7+~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0333621	01/12/2009	TX	65.0	65		F	01/05/2009	Pain redness- burning at injection site chills, fever, nausea and shortness of breath and extreme fatigue- symptoms lasted 4-5 days and arm was painful to touch for about 2 weeks.									Y	11/11/2008	11/11/2008	0	None	PVT	OTH	None	None	Sulfa			1						2	Chills; Dyspnoea; Fatigue; Injection site erythema; Injection site irritation; Injection site pain; Nausea; Pain in extremity; Pyrexia	FLU3~CSL LIMITED~01049111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~2|PPV~MERCK & CO. INC.~1161X~1~SC~LA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0337037	01/12/2009	FL	25.0	25		F	12/29/2008	Cellulitis infection near injection site of upper left arm.				Y					N	12/23/2008	12/24/2008	1		MIL	MIL	ZANTAC; Folic Acid; FLONASE; Multi vitamin	None	12 weeks pregnant			1						1	Drug exposure during pregnancy; Injection site cellulitis	FLU3~SANOFI PASTEUR~U2941AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1161X~2~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0337040	01/12/2009	CT	17.0			F		Fluctuating total body urticaria.  Treated with antihistamine/steroids.									Y					PVT	PVT	Solodyne	None	None			1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500583D~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0570X~3~IM~LA~HPV (GARDASIL)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B028AA~1~IM~RA~TDAP (BOOSTRIX)~1	USA		Influenza
0337047	01/12/2009	TN	0.8	0	.8	M	12/20/2008	Local reaction redness, swelling for > 3days.									U	12/19/2008	12/20/2008	1		PVT	PUB						1						1	Injection site erythema; Injection site swelling; Local reaction	DTAPIPVHIB~SANOFI PASTEUR~C3201AA~1~IM~RL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~UT2788HA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~D01075~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0337048	01/12/2009	TN	1.0	1	.0	M	12/15/2008	Had temp 102.4 evening following vaccine - mother took him to after hours pediatric clinic who told her to watch him - saw his regular MD on Wednesday - only had small at that time on arm.  Mother states told doctor about visit to after hours ped clinic but he did not really address that issue.  Child started according to mom a high pitched scream day after receiving shots and has been having it off and on since.  She states he starts screaming when he awakens from sleep.  She states he stops when you pick him up and rock him.  She states he started having a rash 12-11-08 - red bumps on his face, chest, stomach, and on back.  She states in A.M. rash is really bad but then goes to just being red areas later on in the day.  Informed mom to make an appt with her pediatrician for evaluation.  She voiced understanding of instructions.  Called mom back today at 2:45 PM.  She states child is doing better, redness in face gone - but still has bumps on both arms and his stomach.  States will schedule appt with pediatrician.				Y					N	12/09/2008	12/15/2008	6	None	PUB	PUB	None	At PE appt had small rash anterior hand R arm - 15 mm site			TN08042	1						1	Body temperature increased; Erythema; Rash; Screaming; Urticaria	FLU3~SANOFI PASTEUR~UT2787DA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB257AA~1~UN~RL~HEP A (HAVRIX)~1|HIBV~SANOFI PASTEUR~UF488AA~3~UN~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C50457~4~UN~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0337051	01/12/2009	HI	11.0	11		F	12/17/2008	Right arm redness 7.5cm x 3.5cm, tender and itchy for 2 days. Rx'd  Benadryl.									Y	12/15/2008	12/16/2008	1	None	PUB	PUB	TB Test PPD JHP Pharm. 85857 ID/L Forearm	None	None			1						1	Erythema; Pruritus; Tenderness	FLU3~SANOFI PASTEUR~U2806AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0843X~2~IM~LA~HPV (GARDASIL)~1|TDAP~SANOFI PASTEUR~C2863AA~2~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0337052	01/12/2009	MN	2.0	2	.2	F		Temperature unknown. Symptoms include, wheezing, runny nose, difficulty breathing through nostrils, time course - ongoing following administration of FLUMIST. LAN. Symptoms are on a daily bases to this present day, although the runny nose has ended, medications for bacterial infections and allergies given; neither resolved the symptoms.				Y					N	09/30/2008	10/03/2008	3	No Lab test have been performed or suggested.	PVT	UNK	None	None	None			1						1	Dyspnoea; Rhinorrhoea; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500555P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0337054	01/12/2009	MI	51.0	51		F	01/06/2009	Pain at injection site for 2 months.				Y					N	11/06/2008	11/06/2008	0		PVT	PVT		None	None			1						1	Injection site pain	FLU3~CSL LIMITED~0254911A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0337055	01/12/2009	WV	4.0	4		F	12/10/2008	At approx 11:30 am pt developed rash on face, neck, and chest.  Dr checked pt.  Administered 1 teaspoon BENADRYL and 1 teaspoon prednisolone observed pt for 20 minutes.  Dr re-evaluated pt.  Pt. stable, no distress noted.  Pt. released.									Y	12/10/2008	12/10/2008	0		PUB	OTH			Herpes Simplex Virus (oral)			1						1	Rash	DTAP~SANOFI PASTEUR~C2958BA~5~IM~LA~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500553P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~A1060~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1083X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1317X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0337056	01/12/2009	OR	8.0	8		M	12/31/2008	12/30 Mom noticed swelling at injection site after 5:00PM , 0 fever; spoke with on call triage nurse; applied cool compress; Rx Benadryl, Motrin 12/31 erythema  +  swelling slightly larger than 12/30 at 2in diameter; afebrile; will cont treatment cool compress, Motrin + Benadryl									U	12/29/2008	12/30/2008	1		PVT	OTH	None	None	None			1						1	Injection site erythema; Injection site swelling	FLUN3~MEDIMMUNE VACCINES, INC.~500585P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~1393X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0337059	01/12/2009	MI	62.0	62		F		Pt states about 2-3 days after injection her arm felt red and warm, told to put ice on it & take TYLENOL - 2 days later she went to ER where they lanced it & she had cellulitis & put on ABx- from there she heal well.				Y					Y	10/02/2008	10/13/2008	11		PVT	PVT						1						1	Cellulitis; Erythema; Incisional drainage; Skin warm	FLU3~SANOFI PASTEUR~U27466A~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0337064	01/12/2009	MI	90.0	90		F	01/07/2009	Elevated swelling with in duration and elevated warmth at site of vaccination treated with ice.									Y	10/23/2008	10/23/2008	0		PVT	PVT	MACROBID, EMYCIN, PABA, DEMEROL, CATAPRES, TEQUIN,		Patient has several allergies- sulfa, vibromycin, CELEBREX, TRIMAX, ROBITUSSIN M, MIACALCIN, codeine and LOTREL,			1						1	Injection site induration; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2762AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337065	01/12/2009	GA	44.0	44		F	01/06/2009	States she had nausea and chest pain within 30min. Then aching felt bad. Went to bed. Woke and went to toilet 4 hours after vaccine. Passed out knocked head. Went to ER. Assessed and sent home.				Y					Y	10/13/2008	10/13/2008	0	Chest X-ray; Cardiac Enz; SMA 22; PTT/INR; CBC; U/A - no significant findings	PVT	PVT	Triad/ HCTZ 37.5 Qday; Estradiol 1mg Qday; fluoxetine  20mg - one Qday.	None	None	Faint~Influenza (Seasonal) (no brand name)~UN~0.00~In Patient		1						1	Cardiac enzymes normal; Chest X-ray normal; Chest pain; Feeling abnormal; Full blood count normal; Head injury; Laboratory test normal; Loss of consciousness; Nausea; Pain; Urine analysis normal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA389BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0337067	01/12/2009	PA	57.0	57		M	01/12/2009	Patient received a pneumococcal vaccine (in left thigh), an influenza vaccine (in left arm) and his 3rd hepatis A&B vaccine of the series (in left thigh) on 11/3/08.  Later that night, patient developed warmness, swelling, redniess, and itching involving the whole left anteromedial thigh.  Patient also had fever for 1 day.  Veteran had received his previous 2 doses of hepatitis A&B on 5/14/08 and 6/13/08 without incident.  Had received influenza vaccine in previous years without incident.  Patient was prescribed cephalexin 500 mg qid x 10 days as he also had an elevated white blood cell count.				Y					Y	11/03/2008	11/03/2008	0	WBC 15,000 on 11/5/08, neutrophils 10.1 on 11/5/08, mono 1.3 on 11/5/08, rest of CBC WNL.  Temperature 98.9 on 11/5/08.	UNK	UNK	citalopram 80 mg daily, mirtazapine 15 mg qhs, gabapentin 800 mg q6h, metformin 500 mg bid, niaspan 1500 mg qhs, tramadol 50 mg bid prn	None	no previous allergies.  PMH includes mood disorder, hyperlipidemia, right AKA with phantom limb pain, GERD, major depressive disorder, diabetes, elevated LFTs, and hip arthralgia.			1						1	Body temperature; Full blood count; Injection site erythema; Injection site pruritus; Injection site swelling; Injection site warmth; Monocyte count normal; Neutrophil count increased; No reaction on previous exposure to drug; Pyrexia; White blood cell count increased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~GSKAFLLA174AAQ~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB132AC~3~IM~LL~HEP A + HEP B (TWINRIX)~1|PPV~MERCK & CO. INC.~0742X~1~IM~LL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0337071	01/12/2009	ND	14.0	14		M	01/12/2009	Four hours after vaccination, patient complained of sore arm, then started to complain of wobbly legs, blurred vision, and had high fever, and lasted 24 hours. (as reported by mother)									Y	12/09/2008	12/09/2008	0	none	PUB	PVT				headache, high fever, loss of apetite, vomiting~Tdap (Boostrix)~1~12.00~In Patient		1						1	Muscular weakness; Pain in extremity; Pyrexia; Vision blurred	FLU3~SANOFI PASTEUR~U2770AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337074	01/12/2009	GA	0.35	0	.3	F	01/12/2009	SPOKE WITH MOTHER AND NOTIFIED HER OF ERROR AND ALSO NOTIFIED DR. AND MY PRACTICE MANAGER AND MEDICATION ERROR PERFORMED									Y	01/07/2009	01/07/2009	0		UNK	UNK						1						1	Medication error	FLU3~SANOFI PASTEUR~U2831AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB257AA~1~IM~RL~HEP A (HAVRIX)~1|MEA~MERCK & CO. INC.~1208X~1~SC~LL~MEASLES (ATTENUVAX)~1|PNC~PFIZER\WYETH~DO5879~2~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1222X~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0337081	01/12/2009	OK	55.0	55		F	01/12/2009	Complains of upper right arm pain since vaccine administered. States is painful to raise arm when dressing. No redness, swelling, or pain with palpation.									N	10/24/2008	10/24/2008	0		PUB	PUB	Multivitamin, Aspirin 81mg	None	Seasonal allergies	None~ ()~NULL~~In Patient		1						1	Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2772AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337084	01/12/2009	CO	34.0	34		F	01/12/2009	Breathing difficulty, fever, body aches, tongue swelling, vomit, blood was showing as secondary issue in the nasal airway area and upper throat areas.  Some blood was being vomited due to light airway bleeding.  events happened 4 hours after vaccination.									Y	01/09/2009	01/09/2009	0	Rapid Physical exam/ Oxygen via facemask / benedryl given at urgent care facility.  Nothing more given due to patient being pregnant.	MIL	MIL	None	None	None			1						1	Dyspnoea; Epistaxis; Haematemesis; Oxygen supplementation; Pain; Pyrexia; Swollen tongue; Vomiting	FLU3~SANOFI PASTEUR~U2898FA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337102	01/12/2009	MI	0.5	0	.5	M	12/18/2008	Infant found listless, poor muscle tone AM following vaccination.  Parent felt he had a seizure while sleeping.  Was taken to ER.  Dx with pneumonia, temp of 102.  Neurologist did feel infant had seizure while sleeping but did not feel it was related to vaccinations he had received.				Y					Y	10/17/2008	10/18/2008	1	CBC; Chest X Ray	PUB	PUB	PHENOBARBITOL daily	Cold Sx;  Dx Pneumonia next day	Seizure Disorder			1						1	Body temperature increased; Chest X-ray; Convulsion; Full blood count; Hypotonia; Listless; Pneumonia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B67AA~2~UN~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2788FA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0818U~2~UN~RL~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~C25655~2~UN~LL~PNEUMO (PREVNAR)~1|RV1~GLAXOSMITHKLINE BIOLOGICALS~A41FA691A~2~PO~MO~ROTAVIRUS (ROTARIX)~1	USA	Emergency room visit	Influenza
0337103	01/12/2009	AL	9.0	9		F		FLUMIST received 12/27/08. On 12/30/2008 began experiencing itching of nose, 101 f temperature; aching of neck and back. Dad contacted PMD who did rapid flu swab which was positive. Dad called CDC and was told to rep out it to local health dept.				Y					U	12/27/2008	12/30/2008	3	Nasal swab and blood drawn; Swab was positive	OTH	PVT	None	No	None			1						1	Back pain; Blood test; Body temperature increased; Culture positive; Neck pain; Pruritus	FLUN3~MEDIMMUNE VACCINES, INC.~50054P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0337104	01/12/2009	AL	41.0	41		M	12/31/2008	Flumist received on Saturday, 12/27/08.  On Tues. 12/30/08 began experiencing itching of nasal cavity, nasal infection, nasal bleeding, 101 degrees F temp.; aching neck & back.  Contacted PMD, who did rapid flu which was positive.  Called CDC and was told to report to local health dept.				Y					U	12/27/2008	12/30/2008	3	Nasal swab- rapid for flu +	OTH	PVT	None	No	None			1						1	Back pain; Body temperature increased; Culture positive; Epistaxis; Infection; Neck pain; Pruritus	FLUN3~MEDIMMUNE VACCINES, INC.~50054P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0337088	01/13/2009	WA	70.0	70		F	01/12/2009	This case was reported by a consumer and described the occurrence of injection site burning in a 70-year-old female subject who was vaccinated with Influenza vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included acid reflux, arthritis, hypertension and hypothyroidism. Concurrent medications included SYNTHROID, Indapamide, Omeprazole and Potassium chloride. On 7 November 2008 at 11:00, the subject received unspecified dose of Influenza vaccine (unknown, right arm). On 7 November 2008, immediately after vaccination with Influenza vaccine, the subject experienced injection site burning, swelling injection site, injection site redness, injection site warmth. On 11 November 2008, the subject experienced injection site itching. On 13 November 2008, the subject experienced double vision. On 21 November 2008, the subject experienced optic nerve disorder and eye disorder. On an unknown date the subject experienced hardness injection site. The subject reported the GSK influenza vaccine lot number as GSK 375B4. The subject reported that on 07 November 2008, she received GSK flu vaccine injected into her right arm. She immediately noticed burning at the injection site. She stated that I started swelling and immediately got red and hot. She says it stayed that way and she still has a hardened area on her arm two months later. She took ALLEGRA for two days. She says that on the 6th day after the flu vaccine injection that she developed double vision. She called her internist and he referred her to her ophthalmologist. She had an MRI on 21 November 2008 and was told that the 6th optic nerve of the left eye was affected by an event that affected the muscle of her left eye. She is now wearing a patch because of the double vision but they have not recommended any treatment but recommended a wait and see approach for about 3 months. In addition, they have discussed that she might need surgery to correct the muscle or prisms in her glasses. She says she is still having double vision although it has improved. The subject called where she received the vaccine and they read from the package insert regarding flu vaccines causing optic neuritis and advised her to call GSK to report an adverse event. In addition, she stated that she gets a flu vaccination every year and she estimated that she has had 25 previous flu vaccinations without incident. This case was assessed as medically serious by GSK. The subject was treated with Fexofenadine and eye patch. At the time of reporting the events were unresolved.				Y					N	11/07/2008	11/07/2008	0	UNK	OTH	PUB	Thyroxine sodium; Indapamide; Omeprazole; Potassium chloride	Acid reflux; Arthritis; Hypertension; Hypothyroidism	The subject had previously received influenza vaccinations and no adverse events were reported. No adverse events were reported following receipt of prior immunizations.		A0763069A	1						1	Diplopia; Eye disorder; Immediate post-injection reaction; Injection site erythema; Injection site induration; Injection site irritation; Injection site pruritus; Injection site swelling; Injection site warmth; Optic nerve disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~GSK375B5~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0337089	01/13/2009	OH				F	01/12/2009	This case was reported by a pharmacist (also the subject) and described the occurrence of arm rash in a female subject of unspecified age who was vaccinated with FLUARIX, GlaxoSmithKline.  There were no concurrent medications.  On 27 October 2008 at 11:00 the subject received a dose of FLUARIX in the right arm.  On 29 October 2008, 2 days after vaccination with FLUARIX, the subject experienced a rash on her arms and legs.  The rash has resulted in scarring in the rash areas since the rash has not resolved.  The subject was evaluated three times at an urgent care office.  The pharmacist considered the events were clinically significant (or requiring intervention).  She was first treated with three doses of Depo medrol at 80 mg (this was thought to be the dose).  Then one week later, the subject was prescribed a 6-day prednisone taper for the continuing rash.  The taper started at 50 mg and she was instructed to decrease the dose by 5 mg every 2 days.  At the time of reporting, the subject was at 35 mg and the rash was not improving, but was getting worse.  The subject also tried treatment with Atarax and Zyrtec which did not resolve the rash.  The subject developed bronchitis some time after receiving FLUARIX for which she was prescribed Amoxil.  The subject did not relate the FLUARIX to the development of bronchitis.  The subject initially thought that the Amoxil she was taking for bronchitis was improving the rash, but then the rash worsened again.  The subject has not been evaluated by a dermatologist, nor had a skin biopsy.  Blood work performed was normal.  At the time of reporting the rash was unresolved and worsening at times, scarring was unresolved and the outcome of bronchitis was not specifically mentioned.  The rash was considered possibly related to treatment with FLUARIX.  The pharmacist mentioned that she was not certain of the brand of flu vaccine that she received, but she knew it was a GlaxoSmithKline product and that it was in a single dose syringe (FLUARIX) versus a multidose vial (FLULAVAL).				Y					U	10/27/2008	10/29/2008	2	Blood work performed on an unspecified date was normal.	PVT	PVT	No concurrent medication	Unknown	The subject has not previously received flu shots and has no history of adverse events following previous vaccinations.		A0763072A	1						1	Blood test normal; Bronchitis; Rash; Scar	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0337094	01/13/2009	AZ	1.4	1	.4	M	01/12/2009	Vomiting, fever, Heat @ site.				Y					Y	01/05/2009	01/06/2009	1		PUB	UNK		No	No			1						1	Injection site warmth; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~UT2783GA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0337097	01/13/2009	TX	35.0	35		F	01/12/2009	Developed shaking, shivering with pain around 1am after receiving flu shot at 6 pm night before. Symptoms lasted about 3 hours. Pain was headache.									Y	01/08/2009	01/09/2009	1		OTH	PVT	Excedrin		Penicillin, Ibuprofen			1						1	Chills; Headache; Pain; Tremor	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337098	01/13/2009	WA	19.0	19		M	01/12/2009	Patient filled out info sheet stating he had fainted w/previous injection at Dr's office(date unknown, but in 2008). He came to get FLUVIRIN, TWINRIX and YF-Vax. I gave him Flu and TWINRIX in left arm. Within <1 minute his head went back against the wall and he lost his color in his face. Then he slid off his chair to a sitting up position on the floor and moaned a few times. I panicked, thinking what should I do first? and came into the pharmacy asking to call 911. I grabbed the ekit and went back out to patient. He immediately snapped out of it and said that once he heard my voice he was ok. But then he needed to lie down soon after this- and his color was not better. He also was sweaty on his face and felt nauseous and asked for a bag to breathe in and out of. I gave him a bag and a dixie cup of water-but before I got these for him I came back into pharmacy and call 911. They came w/in 10 minutes and measured BP, pulse, etc. He continued lying on the floor while they questioned him and then about 10 minutes later they asked me to give his YFVax while they were still there. I did, and he seemed fine. They recommended he, go to the hospital and the next time I checked the hallway they were gone.									Y	01/10/2009	01/10/2009	0		OTH	PVT			Previously fainted after receiving vaccinations	fainting~Vaccine not specified (no brand name)~UN~0.00~In Patient		1						1	Head injury; Hyperhidrosis; Immediate post-injection reaction; Nausea; Skin discolouration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB128AB~UNK~IM~UN~HEP A + HEP B (TWINRIX)~1|YF~SANOFI PASTEUR~UF301AA~UNK~UN~UN~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0337132	01/13/2009	CA	1.8	1	.8	F	01/08/2009	Developed cold, cough, vomiting after Influenza vaccination, requiring hospitalization for Pneumonia.  1/26/2009 MR received for DOS 12/15/2008-1/xx/2009. No D/C Summary sent since pt still hospitalized. DX: Pneumonia. S/P Respiratory Failure with intubation.  Pt presented with worsening fever, SOB and cough x 2 days. PE (+) for dry mucous membranes,nasal flaring, retractions and grunting. O2 sat 88% on RA. Started on O2 NC then later intubated for further respiratory decline. May require tracheostomy. TX abx. Still hospitalized.			Y		Y	48			Y	12/09/2008	12/10/2008	1	Labs and Diagnostics:  CXR (+) for likely atelectasis. CT chest (+) for marked volume loss L lung. pH probe (+) for mild reflux. Resp cx (+) Psuedomonas aeruginosa. Brain MRI (+) for ventriculomegaly. Echo WNL. CBC with normal WBCs. RBC, Hct, Hgb,  MCH consistanly low. RDW-CV 19.3-21.5. Retic ct initially WNl up to 4.2. AST235.  ALT 230. LIpase (H) 574. Creatinine low 0.2.	PVT	UNK		None	Cutis Laxa; congenital disorder of Glycosylation. PMH:  Autosomal recessive cutis lax due to congenital defect of glycosylation. Pneumonia. G-tube. Hypotonia			1						1	Cough; Nasopharyngitis; Pneumonia; Vomiting	FLU3~SANOFI PASTEUR~UT2794BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB320BA~2~IM~RA~HEP A (HAVRIX)~1	USA	Life Threatening,Hospitalisation	Influenza
0337133	01/13/2009	WA	16.0	16		F	12/30/2008	Within 5 mins of receiving HPV injection pt became pale, lightheaded, vision became black, diaphoretic. Had pt wheeled to obs. room- monitored pt for 20 min - full recovery - discharged to Mom care.									Y	12/29/2008	12/29/2008	0	None	PVT	PUB	No	No	No			1						1	Dizziness; Hyperhidrosis; Immediate post-injection reaction; Pallor; Visual impairment	FLU3~SANOFI PASTEUR~U2829AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0651X~3~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0337135	01/13/2009	MN	0.9	0	.9	F	01/08/2009	Hours after flu vaccine administered, developed diffuse eczematous rash that persisted months after vaccine given. Rash comes and goes.									U	12/10/2008	12/10/2008	0		PVT	PVT	None	Reactive Airway Exacerbation; URI	Cleft lip/palate			1						1	Eczema	FLU3~SANOFI PASTEUR~UT2799GA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337136	01/13/2009	NC	1.6	1	.6	F	01/09/2009	Seen on 1-7-09 = lt leq red + swollen + warm to touch ordered- TYLENOL, Compresses, HC cream & BENADRYL po-> RECK 1-8-09 -> (on AMOX for OM)- 1-8-09-AB changed to CLINDAMYCIN- Re checked on 1-9-08 -> area of erythema no longer warm to touch- Dx Cellulitis secondary to immunization.				Y					U	01/05/2009	01/06/2009	1		PVT	PUB	None	None				1						1	Cellulitis; Injection site erythema; Injection site swelling; Injection site warmth	DTAP~SANOFI PASTEUR~U2471AA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2799AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB320AA~2~IM~RL~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0337137	01/13/2009	IN	33.0	33		F	01/09/2009	Patient had a flu shot in October 2008.  She felt immediate pain in shoulder, radiating down arm.  She felt the flu shot was given higher up on her shoulder than previous flu shots.									Y	10/01/2008	10/01/2008	0	None	PVT	PVT	ORTHOCYCLIN	None	None			1						1	Immediate post-injection reaction; Musculoskeletal pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~U2808AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0337139	01/13/2009	VT	54.0	54		F	12/03/2008	Burning itch over upper body, extremities + bottoms of feet. Felt very hyper wired. Difficulty sleeping that night, diarrhea, sweats, swollen axillary lymph nodes. Symptoms resolved after 72 hours.									Y	10/21/2008	10/21/2008	0		PVT	PVT	Trazodone; Methacarbenol	None	Injectable iron; Celiac Disease; Fibromyalgia			1						1	Agitation; Burning sensation; Diarrhoea; Hyperhidrosis; Insomnia; Lymphadenopathy; Pruritus	FLU3~SANOFI PASTEUR~U2787EA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337141	01/13/2009	MN				U		Right Arm cellulitis.				Y					Y	10/09/2008	10/13/2008	4		PVT	OTH			Hx of breast (L) CA not same arm.			1						1	Cellulitis	FLU3~SANOFI PASTEUR~U2758AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0337142	01/13/2009	PA	63.0	63		F		10/20/08 Vaccinated at 9AM- Pain in left upper arm 4PM and continues. Shot was given top of arm at shoulder in back. Saw family doctor, neurologist 12/08. Appt 1/13 with orthopedic Dr. Pain still in left arm and into shoulder cap. Condition is on going.									N	10/20/2008	10/20/2008	0	MRI, 11/29/08; EMG, 12/10/08	PUB	PUB	Levothyroxine; Restasis; Dicyclomine	None	Low Thyroid			1						1	Electromyogram; Injected limb mobility decreased; Nuclear magnetic resonance imaging; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLVA357CA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0337143	01/13/2009	NJ	3.0	3		F	12/28/2008	Slept 14 hours; woke up dizzy; then complained of a stomachache.									Y	12/15/2008	12/16/2008	1		PVT	OTH						1						1	Abdominal pain upper; Dizziness	FLU3~SANOFI PASTEUR~U2788DA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337162	01/13/2009	OK	6.0	6		F	01/13/2009	PT PRESENTED TO OFFICE ON 12-24-08 WITH C/O SORE THROAT, COUGH AND FEVER.  STREP SCREEN PERFORMED, RESULTS NEGATIVE.  DR. DX'D PT WITH POSSIBLE FLUMIST SIDE EFFECT.									Y	12/22/2008	12/24/2008	2		UNK	UNK	NONE	NONE.  PT SEEN FOR ROUTINE PHYSICAL.	ECZEMA	NA~ ()~~0.00~In Patient|NA~ ()~~0.00~In Sibling|NA~ ()~~0.00~In Sibling		1						1	Cough; Oropharyngeal pain; Pyrexia; Streptococcal identification test; Streptococcal identification test negative	FLUN3~MEDIMMUNE VACCINES, INC.~500560P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337169	01/13/2009	TX	0.6	0	.6	F	01/13/2009	Child had seizure 7 hours after 2nd dose of flu vaccine; Patient went to Hospital and was admitted. 3/5/09 MR received for DOS 1/13/09 with D/C DX:  Vaccine Reaction. Pt presented with seizure-like activity of unresponsiveness, eyes rolling back and stiffness.  PE WNL in ED. No further activity. D/C home.					Y	1			Y	01/12/2009	01/12/2009	0	Pending per hospital. Labs and diagnostics:  Tox screen (-). Chemistry unremarkable. EEG WNL.	UNK	UNK		contact dermatitis	none. PMH:  none			1						1	Convulsion	FLU3~SANOFI PASTEUR~UT2794CA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0337173	01/13/2009	AZ	58.0	58		F	01/13/2009	10/16/08 1 PM-PT REPORTED FREQ NON-PRODUCTIVE COUGH AND BRONCHOCONSTRICTION (FELT LIKE CHILDHOOD ASTHMA, BUT NOT ANAPHYLAXIS). 5 PM-PT REPORTED LABORED BREATHING, MALAISE, HA, UPPER LIP SWELLING.  PT TOOK 2 BENADRYL (50 MG) AND LIP SWELLING IMPROVED.  TEMP SPIKE 101 F, VERY TIRED, HARD TO MOVE.  7 PM-PT REPORTED VISIT TO URGENT CARE.  NP SAID LUNGS SOUNDED OK, MOVING AIR FINE.  NP TOLD PT LIKELY SHE WAS MOUNTING AN IMMUNE RESPONSE.  10/17/08 AM-PT REPORTED FEELING TIRED BUT NO FEVER OR DIFFICULTY BREATHING.				Y					Y	10/16/2008	10/16/2008	0	NONE	UNK	UNK	ESTROGEN, TESTOSTERONE CREAM, VOLTAREN, CALCIUM, GLUCOSAMINE, MULTIVITAMIN	NONE	ALL: SULFA (ANAPHYLAXIS); GENTAMICIN, TETRACYCLINE, ULTRAM (RASH). BIRTH DEFECTS: NONE. MED CONDITIONS: HRT, HIP & BACK ARTHRITIS.			1						1	Body temperature increased; Bronchospasm; Cough; Dyspnoea; Fatigue; Headache; Lip swelling; Malaise	FLU3~SANOFI PASTEUR~M2769AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0337176	01/13/2009	IL	11.0	11		F	01/13/2009	Itchy rash, raised bump at the site, soreness from elbow to shoulder.									Y	01/13/2009	01/13/2009	0		PVT	PUB		NA	na			1						1	Injection site mass; Injection site pain; Injection site pruritus; Injection site rash	FLU3~SANOFI PASTEUR~U2840AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337178	01/13/2009	MI	38.0	38		F	01/13/2009	1-10-09 11am stiff neck, tight jaw muscles. 13:30 Left arm bottom itched, 1x4 hard lump w. red edges sprayed w/ bactine and took anti-histimine. 16:30 lump now 2x6. 22:30 lump 3x7 and shoulder joints very sore. 1-11-09 9:30 lump is all pink now 5x9 and sore. 101 Fever. took Tylonol and anti-histimine. 13:30 102 fever. muscles, joints, bones, fingers, legs, hips, groin glandsextremely sore (much worse than the flu) more tylenol. 17:00 Pain worse, fever 101 and lump 5x10. 1-12 8:30 fever 101. pain less but extremities and hips & shoulders still bad.  Edge of lup not as distinct but larger area of original lump yellowish and the other site 1.5  sore red lump. 1-13 pain less. Fever 99.5 left side of neck and head painful, large lump not as obvious but more yellow. Other lump still red 1.5				Y					N	01/10/2009	01/10/2009	0	I called the afterhours nurse hotline and told her my symptoms and she said to get to ER now. I asked what they could do for me in ER and she said nothing, so I did not go. I called my regular Dr on Monday and a nurse called me back and just said sorry but there is nothing we can do.	PVT	UNK	Pamelor 50. Effexor XR 150. Prevacid 30. Corgard 120. Glucophage XR 2000. Vitamin D 4000IU	None	Allergy to sulfa, Type II Diabetes, Chronic migraines, Chronic Vitamin D deficiency, GERD			1						1	Arthralgia; Erythema; Induration; Mass; Muscle tightness; Musculoskeletal pain; Musculoskeletal stiffness; Myalgia; Pain; Pruritus; Pyrexia; Skin discolouration	FLUX~UNKNOWN MANUFACTURER~~7+~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~LA~PNEUMO (NO BRAND NAME)~1|TDAP~UNKNOWN MANUFACTURER~~UNK~UN~LA~TDAP (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0337187	01/13/2009	NM	52.0	52		F		Swelling of entire arm down to fingers. Erythema at site.									Y	01/06/2009				PVT	PVT			Allergies PCN; Cortisone; Tetanus per pt.			1						1	Injection site erythema; Oedema peripheral	FLU3~CSL LIMITED~01749111A~2~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~0981X~2~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0337189	01/13/2009	NY	1.7	1	.7	M	01/13/2009	Swelling to LL at site of vaccine. Advised to use cool compresses to site and to call office if more concerns.									U	01/07/2009	01/09/2009	2	None	PVT	PVT	None	None	None			1						1	Injection site swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B085BA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2787AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB259AA~2~IM~RL~HEP A (HAVRIX)~1	USA		Influenza
0337190	01/13/2009	NY	1.01	1	.0	M	01/09/2009	Fever (low grade), rash of a vesicular inflamed type; located proximal to injection site, began 2 3 wks after injection, looking like a red bump that further erupted with vesicles.				Y					Y	12/05/2008	12/17/2008	12	None	PUB	UNK	None	No	Cow milk allergy.			1						1	Inflammation; Pyrexia; Rash vesicular; Urticaria	FLU3~SANOFI PASTEUR~UT2787AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1502U~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0337192	01/13/2009	NC	26.0	26		F	11/12/2008	Patient developed low back pain that radiated after 30 minutes to abdomen. Pain described as cramping / pressure. 7 on pain scale of 0-10 generalized over entire abdomen. c/o nausea . Pain elevated with ambulation. Most comfortable position was bending forward. Pain abated at 2pm  11-5-08. Patient was seen in employee health and referred to emergency room at hospital on the morning of 11/5/08. Labs, urine and pap smear were done. No problem identified. Referred by emergency Department for follow up at primary care provider .				Y					Y	11/04/2008	11/05/2008	1	All WNL per pt	PUB	PUB	NUVARING		2005 - Anemia Hx: of Ovarian and breast Cyst		NC09003	1						1	Abdominal pain; Back pain; Laboratory test normal; Muscle spasms; Nausea; Smear cervix normal; Urine analysis normal	FLUN3~MEDIMMUNE VACCINES, INC.~500544P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0337195	01/13/2009	NY	16.0	16		M	01/13/2009	Mom stated child had congestion, sweats, tiredness and cough since given FLUMIST. Advised to use asthma meds and follow up w/ MD if symptoms worsen.									U	11/21/2008	11/21/2008	0	None	PVT	PVT		None	Controlled asthma			1						1	Cough; Fatigue; Hyperhidrosis; Nasal congestion	FLUN3~MEDIMMUNE VACCINES, INC.~500561P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337196	01/13/2009	CT	26.0	26		F	01/06/2009	Left arm pain since flu shot reported on 12/5/08.  As of 12/16/08 saw MD, diagnosed with bursitis, RELAFEN prescribed.  May need cortisone injection if not better.  Pain decreased with RELAFEN.				Y					U	11/07/2008	11/07/2008	0		PUB	PVT		No				1						1	Bursitis; Pain in extremity	FLU3~SANOFI PASTEUR~U2751AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0337197	01/13/2009	CT	70.0	70		M	01/06/2009	Pt states his whole right arm was swollen, red & sore down to the elbow for 3 days following vaccination.  Did not see MD.									Y	11/04/2008	11/05/2008	1		PUB	PVT		No				1						1	Erythema; Oedema peripheral; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA357CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0380U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0337199	01/13/2009	CT	72.0	72		M	01/12/2009	Pt states his whole right arm was swollen red & sore from shoulder to finger tips.  Applied warm soaks with relief.  Slight swelling & redness still noted 10/27/08.									Y	10/23/2008	10/23/2008	0		PUB	PVT		No				1						1	Erythema; Injection site swelling; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881132P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0380U~2~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0337204	01/13/2009	CT	50.0	50		F	01/06/2009	12/10/08 Reported persistent pain after flu shot.  Saw MD, was told injection hit a nerve.  1/5/09 Pt reports receiving cortisone shots for bursitis.  Now starting Physical Therapy.				Y					N	11/11/2008	11/11/2008	0		PUB	PVT		No				1						1	Bursitis; Pain	FLU3~SANOFI PASTEUR~U2751AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0337209	01/13/2009	NC	57.0	57		F	11/12/2008	Infection of left deltoid following Influenza vaccination on 11/4/08. 11/5/08 increased soreness, fever and chills; 11/7/08 went to primary care diagnosed allergic reaction and prescribed pain medication. 11/8/08 went to urgent care diagnosed with cellulitis prescribed cephalexin 500 mg TID 11/8/08 and 1/9/08 fevers of 102 degrees F 11/10/08 went to family practice labs done. 11/12/08 WBC 19.5 per lab on 11/11/08. Clindamycin 300mg TID x 15 days Doxycycline 100mg TID x 15 days prescribed . negative 11/12/08 all symptoms abated-patient finally recovered.				Y					Y	11/04/2008	11/05/2008	1	Ultrasound; WBC	PUB	PUB	None	None	None		NC09001	1						1	Cellulitis; Chills; Hypersensitivity; Infection; Pyrexia; Tenderness; Ultrasound scan; White blood cell count	FLU3~SANOFI PASTEUR~U2811AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0337211	01/13/2009	NY	48.0	48		F	01/12/2009	45 minutes after injection - developed bilat. chest pain and around to back. Short of breath. Took Benadryl 50mg PO and felt better in 5-10 min. Also had a lot of indigestion and belching.									Y	11/06/2008	11/06/2008	0	None	PUB	PVT	HCTZ 25mg qd; Lipitor 10mg one qd.	None	Allergies: Morphine			1						1	Chest pain; Dyspepsia; Dyspnoea; Eructation; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88635~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0337246	01/14/2009	MA	14.0	14		F	01/12/2009	VARIVAX & influenza given in left arm 12/1/08, returned to office 12/4/08, developed rash 12/3/08 which is expanding, area itchy, located medial left upper arm, central papular 2 X 25 cm central exudated area. 7 X 10 cm surrounding erythemea & heat, Temp 98.1 degrees F.									Y	12/01/2008				PVT	PVT	None	None, Well Visit	None			1						1	Injection site discharge; Injection site erythema; Injection site papule; Injection site pruritus; Injection site rash; Injection site warmth	FLU3~SANOFI PASTEUR~U2762AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0509X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0337321	01/14/2009	RI	78.0	78		M	01/14/2009	Patient began with cough and upper respiratory infection after vaccine administered.  Patient began taking over the counter meds and got worse.  Patient began to have difficulty walking and unsteady gait came to the ER and was admitted to Charlton Memorial Hosp on 12/29/08.  Patient was treated with supportive therapy and IGG, and condition is improving. Patient is still in the hospital. 1/15/09- received-presented to ED with C/O cough, unsteady walking, balanace. Cough times week. ED DX: URI, bronchospasm, polypharmacy abuse. Unsteady gait. Tingling of extremities. Generalized body aches, fevers. 1/21/09-DC summary received for DOS 12/29/08-1/15/09 DC DX: Guillain-Barre syndrome, recovered almost completely. Ileus, recovered. Urinary retention. Chronic obstructive pulmonary disease (COPD). Hypertension. and DC DX summary for DOS 1/15-1/21/09 DX: Status post neuropathy likely a variant of Guillaine-Barre. Status post treatment with IVIG and high dose steroids. Painful paresthesias, tremulousness, weakness and ataxia and inability to mobilize. Treated with IVIG.					Y	17			U	11/25/2008	12/29/2008	34	U/A, CXR, CBC, CMP, Head CT-done in the ER 12/29. 1/15/09-records received- MRI negative. CT normal. Urine tox negative.WBC 14.3.  1/21/09-records received- EMG demonstrated acute inflammatory demyelinating polyneuropathy thought to be a variant of Guillaine-Barre.	UNK	UNK	Dayquil, Nyquil, Benadryl, Tylenol	none 1/15/09-records received- Cough times week.  Patient was diagnosed with pneumonia and started on Zithromax. Pneumonia on antibiotics prior to ED. 1/21/09-records received- Respiratory infection.	none 1/21/09 records received-PMH: Kidney stone. Diverticulitis. history of DJD. Chronic sinusitis.			1						1	Chest X-ray; Cough; Full blood count; Gait disturbance; Metabolic function test; Urine analysis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA389BA~6~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0337322	01/14/2009	FL	51.0	51		M	01/14/2009	01/05/2009 Increase Tempature/  01/06/2009 Tempatrue, nausea, fatigue, headache.									Y	01/05/2009	01/05/2009	0		PUB	PUB	dilantin/ritalin/steroids.	none	Seizure disorder/chronic hepatitis C			1						1	Body temperature increased; Fatigue; Headache; Nausea	FLU3~SANOFI PASTEUR~U2832AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337332	01/14/2009	NC	28.0	28		F	01/14/2009	Flushot given around 11AM? About 3 hours after flu shot-started coughing and had a tickle in my throat, cough became more frequent, then heart rate up to 100-110. Felt like my throat was swollen, trouble swallowing. Gave myself 50mg of Benadryl and cough began to subside about 30min after. Swollen throat began to feel better a few hours after Benadryl. Later that evening started with fever (102-103F) and chills. Took 650mg Tylenol. Cough had completely subsided by then and throat was much better. Felt completely fine in the morning (no fever, chills, coughing, swollen throat).									Y	10/23/2008	10/23/2008	0	none	PUB	PVT	Loestrin 24-one daily, Nexium 40mg-one daily	none	acid reflux, pvc's, migraines, viral meningitis 3 weeks prior to flu shot			1						1	Chills; Cough; Dysphagia; Heart rate increased; Pharyngeal oedema; Pyrexia; Throat irritation	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0337335	01/14/2009	MI	36.0	36		M	01/14/2009	Approximately 2 hours after received flu shot client starting sneezing and coughing.  Eye lids began to swell and had difficulty breathing.				Y					Y	12/05/2008	12/05/2008	0		UNK	PVT		no	Client states he takes allergy medication for environmental allergies			1						1	Cough; Dyspnoea; Eyelid oedema; Sneezing	FLU3~SANOFI PASTEUR~u2765aa~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0337341	01/14/2009	MN	26.0	26		F	01/14/2009	4 hours after shot administered, felt chest pressure, heart pounding, congested chest & cough.  Breathing problems also which lasted about 25 minutes, rest of symptoms persisted for about 3.5 hours.									Y	01/09/2009	01/09/2009	0		PUB	PVT	none	none	none			1						1	Chest discomfort; Cough; Dyspnoea; Palpitations; Upper respiratory tract congestion	FLU3~SANOFI PASTEUR~U2770AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337347	01/14/2009	GA	6.0	6		F	01/14/2009	SHE RECEIVED THE FLU SHOT IN MID-OCTOBER AND DISPLAYED A FEVER DURING VETERAN'S DAY WEEKEND WITH NO OTHER SYMPTOMS.  SHE FELL OFF THE MONKEY BARS AT SCHOOL ON NOV 13 AND STARTED TO COMPLAIN OF TINGLING AND LOSS OF 'CONTROL' OF LIMBS ON RIGHT SIDE ON NOV 14.  SHE STARTED LOSING HER VOICE NOV 30.  SHE COMPLAINED OF HER HEAD TINGLING ON DEC 9 AND SUBSEQUENTLY WENT TO DOCTOR ON DEC 10 AND HAS HAD MRI'S, NERVE CONDUCTION TESTS, ETC AND WAS FINALLY DIAGNOSED WITH GBS ON/ABOUT DEC 12. 1/16/09-records received for DOS 12/10-12/13/08-DC DX: Guillain-Barre syndrome. Presented with C/O tingling all four extremities for about 4 weeks, back pain and leg pain. Day prior to hospitalization fell from monkey bar approximately 6 feet high. Subsequently C/O tingling in all 4 extremities. Seen by chiropractor. Few days later lost voice, whispery and hypophonic. DX: sciatica and recommended bedrest for 1 month. PE: reflexes absent ankle and knee jerk bilaerally. 12/29/08-follow-up visit with neurology, after 12/25/08 developed left facial palsy and at time of visit nearly resolved.  Voice remains with whisper and occasionally chokes on liquids. Jerky gait. Mild weaknesses throughout. 1/9/09-admitted with multiple cranial nerve palsy.  Began IVIG.  Discharged 1/13/09.  Follow-up 2/16/2010: Patient was down graded from GBS to CIDP and is getting monthly IVIG treatments.				Y	Y	7			N	10/16/2008	11/11/2008	26	NERVE CONDUCTION, MRI, BARIUM SWALLOW TEST, 1/16/09-records received-CSF: protein 77, glucose 52. NCV abnormal, F-wave. MRI normal. Nerve conduction studies and electromyelography: general acquired sensorimotor polyneuropathy, mixed. CBC, BMP, liver function tests, total protein and albumin level normal. Creatinine kinase slightly elevated.	MIL	MIL		NONE	NONE			1						1	Aphonia; Asthenia; Barium swallow; Fall; Nuclear magnetic resonance imaging; Paraesthesia; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0337354	01/14/2009	VA	20.0	20		U	01/14/2009	The patient states with every flu vaccination since 2000 he will have URI symptoms (post nasal drip, nasal congestion, rhinnorhea, dry cough, watery eyes, rare body aches. No fever, sneezing, itchy eyes, N, V, D, severe body aches) starting 2-3 days after the vaccination and lasting 2-4 days. He treats the symptoms with OTC meds. He will be symptom free for about 4 weeks and then the cycle will repeat for 7-8 months. These sysmtoms do not result in the need to increase the use of this albuterol inhaler which he typically uses 2 times per week. In 2004 and 2006 when he did not have the influenza vaccination the pt did not experience these symptoms. Symptoms: Nasal Drainage, Watery eyes, Cough dry.										06/16/2000	06/19/2000	3	None known	UNK	UNK	None	None	None			1						1	Cough; Lacrimation increased; Nasal congestion; Pain; Postnasal drip; Rhinorrhoea; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~U0168AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~UNKNOWN MANUFACTURER~~UNK~UN~UN~MENINGOCOCCAL (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~IM~UN~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0337363	01/14/2009	IN	12.0	12		F	01/14/2009	Patient eyes swollen shut, itchy. BENADRYL 2 Tsp PO Q6 PRN.									Y	01/13/2009	01/14/2009	1		PUB	UNK		Well check				1						1	Eye swelling; Pruritus	FLU3~SANOFI PASTEUR~U2800BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0652X~UNK~IM~RA~HPV (GARDASIL)~1	USA		Influenza
0337419	01/15/2009	NC	25.0	25		M	01/15/2009	SM who received multiples doses of ENGERIX-B within a one year time period, later diagnosed with MS. Symptoms: Loss of vision (CN II), weakness, headache, migraine. Prior to receiving multiple doses of the ENGERIX-B, Lt was in excellent shape and usually ran 6-12 miles almost everyday. Although he received his last ENGERIX-B in Feb 2007 and did not develop any acute symptoms until Jan 2008, he notes that in May/June of 2007 that he had a pins/needles sensation in the L leg, when it was scratched on the back. On his last PT test in Sept/Oct time frame of 2007, he received his lowest PT score ever. His usual score was a 270-280, he received only a 220.  1/23/09 Received medical records. FINAL DX: multiple sclerosis Records reveal patient experienced pins & needles sensation in legs, decreased energy, sudden onset blurred vision, mustle weakness in legs, loss of taste sensation.  Hospital admit 1/08.  Developed migraine HA after LP.  Continued w/decreased vision, unsteady gait & poor muscle coordination.  Tx w/meds including interferon.  Prior AD Army, now out of service on disability retirement due to progression of his MS. This case was reviewed at at neurology teleconference on 1/14/08 and assigned a WHO Causality assessment of unlikely because neurologists felt that there was no close temporal association between the last vaccine and onset of symptoms.				Y	Y			Y	N	02/01/2006	05/01/2007	454	MRI/MRA of brain, 1/19/08, Abnormal with and without contrast, with findings that are of concern for primary or secondary demyelinating disorder with primary consideration given to multiple sclerosis. There are several lesions at the supra and infratentorial compartments to include several lesions at periventricular white matter as well as additional subcortical foci of signal alteration at frontal and paramedian right parietal lobes. There is also a lesion of the dorsal aspect of the upper pons and lower mid brain. faint enhancement at the subcortical focus along paramedian right parietal lobe as well as at the dorsal pons and may be reflective of areas of active demyelination; Jan 08 labs, CSF cultures negative for both bacterial and fungus; CSF: Protein, 43; RBC, 9; WBC, 11; PMN, 2; Mononuclear, 98; Glucose, 85; CMV Abs IgG/IgM, neg; EBV Ab to Viral Capsid Ag, IgG/IgM, neg   LABS: MRI/MRA brain abnormal w/demyelinating lesions c/w MS.  MRI spine abnormal & c/w MS.   LP.  CT head WNL.  CSF: protein 43, glucose 85, RBC 9, WBC 11, monos 98(H), c/s neg.	MIL	MIL	None	None	None  PMH: hospitalized w/food poisoning 2001.			1						1	Asthenia; Blindness; CSF bacteria no organisms observed; CSF glucose increased; CSF mononuclear cell count increased; CSF polymorphonuclear cell count decreased; CSF protein normal; Computerised tomogram head; Coordination abnormal; Cytomegalovirus antibody negative; Disability; Epstein-Barr virus antibody negative; Fungus CSF test negative; Headache; Laboratory test normal; Lumbar puncture; Migraine; Multiple sclerosis; Muscular weakness; Nuclear magnetic resonance imaging brain abnormal; Nuclear magnetic resonance imaging spinal cord abnormal; Paraesthesia; Red blood cell count increased; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB171AB~UNK~IM~UN~HEP B (ENGERIX-B)~1|IPV~UNKNOWN MANUFACTURER~~UNK~SC~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~~UNK~UN~UN~MENINGOCOCCAL (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~SC~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0337420	01/15/2009	OH	60.0	60		F	01/12/2009	1-05-2009 received flu vaccine. Pt reports that evening feeling chilled, dizzy, weak, severe aching bit. Forearm and difficulty breathing, pale, HR102,BLP 132/751 no fever, lasting approximately 4 hours or until going to sleep									Y	01/05/2009	01/05/2009	0		PVT	PVT	Glucophage, Lotrel, Caltrate	None	Diabetes 2 , HTN, HLD			1						1	Asthenia; Chills; Dizziness; Dyspnoea; Heart rate increased; Malaise; Pain; Pallor; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89969~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~09894~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0337421	01/15/2009	NH	53.0	53		F	01/12/2009	Pt developed cellulitis on the site of Pneumococcal vaccine with fever, vomiting 01/9/09.  11 1/2 hours after the shot treated with Abx augmentin.				Y						01/09/2009	01/09/2009	0	None	PVT	PVT	None	No	Diabetic			1						1	Injection site cellulitis; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2766AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0669X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0337424	01/15/2009	WA	52.0	52		F	01/11/2009	Flu Shot was fine at first but overtime developed aching where vaccine was deposited inside arm to point of interfering with sleep. Also general arm weakness and sharper pain at vaccine site with use. Clinic visit ruled out infection. Tried RX 6-day decreasing course of methylprednisolone. With Rx applied heat. Symptoms decreased with meds and heat but still had some pain with use and general weakness into December. By end of Dec was symptom free.				Y					Y	10/31/2008	11/01/2008	1		OTH	PVT		None	None			1						1	Asthenia; Injection site pain; Sleep disorder	FLU3~CSL LIMITED~01049211A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0337425	01/15/2009	AZ	2.0	2	.1	F	01/10/2009	Pain at sight, fever, non-weight bearing										01/10/2009	01/10/2009	0	None	PUB	PUB	PPV 23, Merck; lot # 0981X; Route/Site LVL; No. Previous Doses, 1	None	None			1						1	Injection site pain; Pyrexia; Weight bearing difficulty	FLU3~SANOFI PASTEUR~UT2785CA~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB236AA~2~UN~RL~HEP A (HAVRIX)~1	USA		Influenza
0337426	01/15/2009	AZ	2.0			M	01/10/2008	Pain at injection site, fever, non-weight bearing													None	PUB	PUB	None	None	None			1						1	Injection site pain; Pyrexia; Weight bearing difficulty	FLU3~SANOFI PASTEUR~UT27856A~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAUB173AA~UNK~UN~RL~HEP A (HAVRIX)~1	USA		Influenza
0337459	01/15/2009	CA	1.4	1	.4	F	01/15/2009	Red, warm to touch rash at injection site.									Y	01/07/2009	01/09/2009	2		UNK	UNK						1						1	Injection site erythema; Injection site rash; Injection site warmth	FLU3~SANOFI PASTEUR~UT2794EA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C73459~UNK~IM~UN~PNEUMO (PREVNAR)~1	USA		Influenza
0337473	01/15/2009	OR	6.0	6		M	01/15/2009	Acute icshemic stroke (basilar artery thrombus).  Underwent mechanical thrombectomy 11/25/08.  2/2/09 Received ER medical records of 11/19/2008. FINAL DX: acute non-specific HA Records reveal patient experienced worsening HA x 5 days w/cloudy vision left eye, fatigue, irritability & nausea.  Had been seen by PCP 2 days prior & dx w/left otitis media.  Tx w/oral antibiotics.  Exam in ER was WNL & tx w/IVF & IV meds.  Improved & d/c to home.  2/3/09 Received PCP office records of 11/17/08-1/18/2009. FINAL DX: left OM w/viral URI Records reveal patient experienced left eye vision deficit, decreased hearing left ear, left side headache, decreased appetite & energy.  Tx w/oral antibiotics & would refer to Ophtho if s/s persisted.  RTC 11/21 s/p ER visit w/URI & OM resolving.  RTC 11/22 w/persistent but intermittent HA & had missed school.  OM had resolved but tx w/oral antibiotics.  Referred for MRI.  RTC 1/12/09 s/p recent hospitalization for acute ischemic stroke with basilar artery thrombus occlusion s/p mechanical thrombectomy on 11/25/08  & having vomiting.  Sent for urgent MRI.  RTC 1/15/09 for conference.  2/09/09 Received hospital medical records of 11/24-12/3/2008. FINAL DX: acute ischemic stroke, basilar artery thrombus occlusion w/resultant bilateral posterior circulation strokes; s/p mechanical thrombectomy 11/25/08. D/C Summary mixed in with records which reveal patient had been transferred to PICU from outlying ER.  Patient experienced retroorbital eye pain & HA x 10 days prior to admit.  One week prior to admit had trouble catching ball from left side.  Five days prior to admit had severe HA behind left eye.  One day prior to admit had dizziness, vomiting, peripheral vision loss but no pain.  On day of admit, had generalized pain, abnormal behavior, talking nonsense, incomplete sentences.  Deficits at d/c included: right arm dysmetria w/minimal weakness, LLE dysmetria, quandrantanopia, dysarthria & left side sensory deficit, required assist to walk due to incoordination.  D/C to inpatient rehab on continued ASA.  was to f/u w/peds neuro & ophtho when d/c from rehab & to have repeat labs.  Neuro. Ophtho clinic notes of 2/3/2009.  Doing well & had returned to school.  Reading speed was significantly slower but otherwise approx same level as prior to stroke.  Had developed behavior issues w/hyperactivity & outbursts. Visual fields deficits.  2/17/09 Received ER records of 11/23 & 11/24/2008. FINAL DX: right occipital lobe AV malformation; acute ischemic stroke left occipital lobe; altered mental status secondary to above; leukocytosis secondary to above. Pt transferred by ambulance due to inclement weather to higher level of care.  Incomplete homonymous hemianopsia, behaviour problems.			Y	Y	Y	20	Y	Y	N	11/05/2008	11/17/2008	12	LABS: WBC 20.9, ANC 17.8(H), lymphs 10.3%(l).  Creatinine 0.3(L), ALK 150(L), AST 58(H).  CT brain abnormal. Protein C 0.72(L), protein S antigen, free 54(L).  CT angiogram abnormal & c/w acute left PCA distribution ischemic infarct.  Echocardiogram WNL.	UNK	UNK			PMH: URI s/s x 1 mo.  Recurrent OM & ear tube insertion.			1						1	Basilar artery thrombosis; Ischaemic stroke; Thrombectomy	FLUN3~MEDIMMUNE VACCINES, INC.~500589P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0337477	01/15/2009	MI	1.25	1	.3	M	01/15/2009	Uncontrollable screaming and fits of rage lasting for 15 minutes at a time, happening since an hour and a half after vaccination. At current time, symptoms still continuing. These screaming/raging bouts are followed by a state of staring and being unaware of surroundings for 5-10 minutes. These bouts have occured at a frequency if about 25 times in the last 48 hours. Redness at injection site is present.  Was told to wait it out, that the symptoms should subside.  Dr. encouraged us to come back if they continue into next week.									U	01/13/2009	01/13/2009	0	None	PVT	UNK	Prevacid 15 mg. twice a day	None	Ulcer, GERD	siezure like symptoms, projectile vomiting, arching of back~Hep B (no brand name)~1~0.20~In Patient		1						1	Anger; Injection site erythema; Screaming; Staring	DTAP~UNKNOWN MANUFACTURER~~4~IM~LL~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~4~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~4~IM~RL~HIB (NO BRAND NAME)~1	USA		Influenza
0337496	01/15/2009	IN	0.9	0	.9	M	01/15/2009	On 1-14-09 per mother at 10:30 pm she felt infant & he was hot.  She gave Tylenol and child had seizure.  Child taken to ER by ambulance with temp of 102.3 F, pulse 157, R 28, 99% O2 RA.  Tylenol given in ER.  Seizure lasted approximately 3 minutes.  Child delivered to home at 01:39 AM.  Temp 99.9 F.  Mom called me on 1-15-09.  This sibling's fraternal twin was vaccinated at same time with same vaccines and had no difficulties.  Mom said no redness at sites and no other s/s.				Y					Y	01/14/2009	01/14/2009	0	BMP creatinine 0.3 mg/dl; Hgb 12.1 g/dl; Hct 36.7%; CXR = WNL; UA-bacteria moderate; CBC - WBC 12.7 x/cmm; RBC 4.34 mb/cmm; temp 102.3 on adm to ER final dx: febrile seizure.	PUB	PUB		None	None			1						1	Bacteria urine; Blood creatinine increased; Blood creatinine normal; Chest X-ray normal; Convulsion; Feeling hot; Haematocrit normal; Haemoglobin normal; Pyrexia; Red blood cell count normal; Urine analysis abnormal; White blood cell count normal	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B133BA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2797FA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF250AC~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C57536~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0337502	01/15/2009	CA	35.0	35		F	01/15/2009	Within 2 hours of vaccination Pt experienced generalized ache ness that lasted 3 days. Itching was significant enough to require antihistamines. No respiratory involvement, angioedema or other S/ Sx. Pt also reported area of redness, swelling and warmth at site of yellow fever injection, lasting 3 days									Y	01/08/2009	01/08/2009	0		PUB	PUB	Oral contraceptives, Celexa xanax, Ambien, Singular, Pulmicort, Zephanal	None	Asthma, Anxiety, Depression, OCD			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Pain; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88635~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|JEV~SANOFI PASTEUR~EJN234A~1~SC~LA~JAPANESE ENCEPHALITIS (JE-VAX)~1|TYP~SANOFI PASTEUR~B0347Z~1~IM~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|YF~SANOFI PASTEUR~UF432AA~1~SC~RA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0337506	01/15/2009	VT	58.0	58		M	01/13/2009	Severe Shaking Chills myalgias for several hours. Resolved spontaneously. Fatigued the next day.									Y	11/05/2008	11/05/2008	0		PVT	UNK		No	No			1						1	Chills; Fatigue; Myalgia; Tremor	FLU3~CSL LIMITED~02449111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|TD~MASS. PUB HLTH BIOL LAB~TD199~UNK~IM~LA~TD ADSORBED (TDVAX)~1	USA		Influenza
0302826	01/16/2009		0.5			F	03/24/2008	This report was received from the Centers for Disease Control and Prevention (VAERS ID 302826) via a healthcare provider and described the occurrence of death nos in a 6-month-old female subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  History was unremarkable.  No previous hospitalizations.  At the 6 month examination, the mother was told that the subject needed tummy time to develop the trunk tone.  Previous and/or concurrent vaccination included inactivated influenza vaccine; Sanofi Pasteur; given on 20 December 2007; live attenuated human rotavirus vaccine; Merck; given on 20 December 2007; pneumococcal vaccine, unspecified; Wyeth given on 20 December 2007.  On 20 December 2007 the subject received 3rd dose of PEDIARIX (unknown).  In December 2007, 2 days after vaccination with PEDIARIX, the subject experienced death nos and cardiopulmonary arrest.  The subject presented to the emergency room into cardiac arrest on full code, asystole and was resuscitated and the heart rate was brought back after several minutes.  According to the mother, she left the child prone over a blanket that had the four ends secure so it would not fold and left the room.  She had heard the subject cry because, according to her, she did not like to be prone.  She had heard the subject cry 5 minutes before she went back into the room and found her completely unresponsive.  She started CPR and paramedics were called who arrived in another 5 minutes.  The subject was intubated and transferred her to the emergency room.  CT scan done in the emergency room showed no bleeding or edema with normal ventricles.  The subject was transferred and hospitalized in the pediatric intensive care unit.  Physical examination showed the baby to be unresponsive to stimuli with gasping rhythmic chest movement with no effective ventilation.  The pupils were 5 mm and fixed.  The subject was on the respiratory oxygenating well.  The capillary refill was fair to poor approximately 4-5 seconds.  Air entry was good and the heart with rhythmic with no murmur.  The abdomen was soft.  There were no bruises on the body or head of the subject.  There was no gag reflex.  A CT scan done at the emergency room showed no bleeding or edema with normal ventricles.  Subject was placed on mechanical ventilation.  A femoral line was placed.  The subject was started on dopamine and DOBUTMINE for low blood pressure and poor perfusion and responded well.  The subject also received albumin 5 percent.  Venous blood gases showed normal oxygenation and ventilation.  Repeat CT scan still did not show any brain edema or hemorrhage.  An EEG was nearly flat that day with no significant cortical activity.  It was reported that over the next 24 hours, nurse noted that the subject had at one points some very sluggish pupil reaction and even very mild response to deep pain in the lower extremities only.  The subject died from death nos.  It was unknown whether an autopsy was performed.  A CT scan done at the emergency room showed no bleeding or edema with normal ventricles.  The next day, repeat CT scan still did not show any brain edema or hemorrhage.  An EEG was nearly flat that day with no significant cortical activity.	Y		Y						N	12/20/2007	12/22/2007	2		UNK	UNK			Unremarkable.  No previous hospitalization noted.  The subject received six month immunizations two days before and has been told the baby needed tummy time to develop the trunk tone and that is what she was doing when the events occurred.		A0717112A	1						2	Breath sounds abnormal; Capillary nail refill test; Cardiac arrest; Cardio-respiratory arrest; Crying; Death; Dyspnoea; Electroencephalogram abnormal; Endotracheal intubation; Mechanical ventilation; Pupil fixed; Resuscitation; Unresponsive to stimuli	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B137AA~UNK~UN~UN~DTAP + HEPB + IPV (PEDIARIX)~2|FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|PNC~PFIZER\WYETH~~UNK~UN~UN~PNEUMO (PREVNAR)~2|RV5~MERCK & CO. INC.~~UNK~UN~UN~ROTAVIRUS (ROTATEQ)~2	USA	Results in Death	Influenza
0337541	01/16/2009	CA	4.0	4		F	01/12/2009	1/5/09 received DTAP, IPV, MMR,Volvox and flu 1/6/09 T100.3 1/7/09 0 fever 1/8/09 fever to  104 lasting 3 day associated with headache 1/11/09 blotchy pink rash on trunk last < 2 yo 1/12/09 Barely visible residual rash and febrile.									Y	01/05/2009	01/08/2009	3		PVT	PVT	Tylenol, Motrin	None	Keratosis plans	low fever~ ()~UN~0.00~In Patient		1						1	Headache; Pyrexia; Rash erythematous; Rash macular	DTAP~SANOFI PASTEUR~C2958BA~5~UN~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2771AA~5~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A04914~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1470X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~139X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0337544	01/16/2009	FL	75.0	75		F		Vaccine injection 3:45p- woke up 9:45 pm same day-fever 102- aches all over body - had headache called doctor next day advised take 2 Tylenol and 3 hrs later, take 2 Ibprophren - alternate until fever gone - Nov 26-came down with bad case of flu .									Y	10/02/2008	10/02/2008	0		PUB	PUB						1						1	Headache; Influenza; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2807AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0803U~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0337600	01/16/2009	FL	66.0	66		F	01/16/2009	Within 30 minutes of vaccination to the left upper arm, patient felt weakness in right side (muscular and joint) from right hip to knee; weakness lasted 45 min to an hour.									Y	10/28/2008	10/28/2008	0	n/a	PVT	UNK						1						1	Hemiparesis; Muscular weakness	FLU3~SANOFI PASTEUR~U2791AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337602	01/16/2009	FL	67.0	67		M	01/16/2009	Patient presented with cellulitis of right arm associated with swelling and axillary lymphadeopathy.  Patient reported fever, chills at home.									Y	10/30/2008	10/30/2008	0	n/a	PVT	UNK						1						1	Cellulitis; Chills; Lymphadenopathy; Oedema peripheral; Pyrexia	FLU3~SANOFI PASTEUR~U2795BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0622x~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0337605	01/16/2009	TX	1.0	1	.0	F	01/16/2009	Patient had a rash on the thighs and face.									U	01/13/2009				UNK	UNK						1						1	Rash	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B065AA~UNK~~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2783GA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB260AA~UNK~~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1210X~UNK~~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C83143~UNK~~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1391X~UNK~~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0337608	01/16/2009	DC	5.0	5		F	01/16/2009	PT RECEIVED EXPIRED FLUMIST LOT 500548P EXP DATE 12/18/2008.  NO REPORTED ADVERSE EVENTS TO DATE OF COMPLETING REPORT.									U	12/22/2008			NONE ORDERED, HOWEVER CONTACTED MEDIMMUNE FOR STABILITY STUDIES AND ADDITIONAL INFORMATION ON USE OF EXPIRED FLUMIST IN CLIENTS.	PUB	PUB	PT RECEIVED PPD TEST DURING SAME WELL CHILD VISIT.	VIRAL INFECTION 079.99	784.7 EPISTAXIS, V40.3 BEHAVIORAL PROBLEMS NEC	N/A~ ()~NULL~~In Patient|N/A~ ()~NULL~~In Sibling1|N/A~ ()~NULL~~In Sibling2		1						1	Expired drug administered; No adverse event; Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500548P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500548P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0337609	01/16/2009	SC	42.0	42		F	01/16/2009	Reported rash & periorbital swelling beginning 11/6/08 - Adverse reaction reported to Employee Health on 11/7/08 - referred to Nurse Practitioner at the Employee Care Center - Rx for Medrol Dose pack & Benadryl. F/U appt. with Dr. 11/10/08 Rx: Prednisone 20 mg qd X 7 days.  Reevaluated 11/17/08 & Prednisone 10 mg 6 additional tablets Rx for tapering. Referral to allergist, who thought it might be thimerosol or latex reaction.  Insert supplied and product identified as preservative and latex free.  1/5/09 Patch testing for several likely allergens conducted by Dr. Results were negative for all patch tests.				Y					Y	11/05/2008	11/06/2008	1	1/5/09 Patch tests performed were negative.  Telephone interview conducted 1/16/09.	UNK	UNK	None	Nasal congestion without fever	Sulfa, Td - told not to take Td unless she had an injury.  Denies birth defects or other medical conditions.	8 days of soreness to arm~ ()~UN~0.00~In Patient|N/A~ ()~~0.00~In Sibling		1						1	Allergy test negative; Eye swelling; Rash	FLU3~CSL LIMITED~02449111A~7+~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0337612	01/16/2009	CA	54.0	54		F	01/16/2009	Patient came to clinic today and presented with a possible reaction to the flu vaccine. The flu shot was administered on October 9, 2008. The patient had a quarter sized, red, swollen area on right upper arm at site of injection. Patient stated that her arm had been like this since she recieved her flu shot in October.									U	10/09/2008	10/09/2008	0		PUB	PVT			allergic to PCN			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337614	01/16/2009	AZ	34.0	34		F	01/16/2009	Patient came to Health Center at 12:06 pm on 1/16/09, 9 days after injections.  Stated prolonged hard lump on my right arm where I got the pneumonia shot.  Lump is smaller now than it has been.  Edges of lump are itchy. Area is still red. Now I also have a rash, mostly on my chest.  Temp - 98.0 F; Pulse - 72; Resp - 20; B/P - 118/72. 3 cm firm lump at injection site, erythema at site, no drainage. Urticaria chest area only. Patient seen by FNP, for further evaluation and treatment.  Local reaction improving over time. Rash probably not related to adverse reaction, however, included in possible reported symptoms.  Patient agreed to apply heat to area, benedryl PRN, bactrim for delayed reaction if worsening in size, heat, tenderness or redness.  Prescriptions written for prednisone 10 mg: 2 tabs today and tomorrow, then one daily until gone; #10 and bactrim DS 800-160; 1 tab q 12 hours; #20. Follow up PRN.									U	01/07/2009	01/08/2009	1	Diagnostic X-Ray done at Medical Center 11/07/2008 positive for acute pneumonia. Chest X-Ray 1/7/2009 done at Health Center was normal.	UNK	UNK		Vaginitis	Augmentin, Morphine, Percocet			1						1	Body temperature; Chest X-ray normal; Injection site erythema; Injection site induration; Injection site mass; Injection site pruritus; Local reaction; Rash; Urticaria; Mass; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA168AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0981X~1~SC~RA~PNEUMO (PNEUMOVAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA168AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~2|PPV~MERCK & CO. INC.~0981X~1~SC~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0337615	01/16/2009	WY	33.0	33		M	01/16/2009	eyes itching, tightness in chest, cough, swelling around his eyes and a bit of difficulty breathing. It was about 4 hours after the shot.				Y						01/13/2009	01/13/2009	0		PUB	UNK						1						1	Chest discomfort; Cough; Dyspnoea; Eye pruritus; Eye swelling	FLU3~SANOFI PASTEUR~u2769aa~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0337617	01/16/2009	CA	2.0	2	.1	F	01/16/2009	Patient had an afebrile seizure event lasting 2-3 minutes the evening after receiving influenza A and Hepatitis A vaccine at her PMDs on 1/14/09.  She was seen in the ED and sent home.  She had 4 more recurrent seizures, all lasting less than 5 minutes over the next 24 hours.  She was admitted to to the pediatric ward and underwent testing which showed a normal MRI.  She was started on leviteracitam and D/C'd home.  No abnormalities or source of seizures were identified, however, given the timing of the vaccines, a report was submitted. 2/17/09-records received for DOS 1/15/09-C/O fall from chair, hit head, eyes rolled up to back of her head, tonic-clonic movements. Presented to ED . At home had two more seizures the next day, crying hard before each seizure. Seen in ED and observed overnight.					Y	1			Y	01/14/2009	01/14/2009	0	CBC - normal, MRI - normal, initial bicarb 15 but this resolved to 20 on recheck, UA negative, Utox negative 2/17/09-records received-Chemistry labs incidated acidosis and a pH of 7.46 respiratory alkalosis with metabolic compensation. MRI no findings. CBC WNL. CT head normal returned  home experienced second seizure. Subsequent CT head normal	UNK	UNK	None at time of vaccination	Mild upper respiratory infection, no sore throat	None			1						1	Blood bicarbonate decreased; Convulsion; Full blood count normal; Nuclear magnetic resonance imaging normal; Toxicologic test normal; Urine analysis normal	FLU3~SANOFI PASTEUR~UT2786FA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1258U~2~IM~RL~HEP A (VAQTA)~1	USA	Hospitalisation	Influenza
0337618	01/16/2009	PA	29.0	29		F	01/16/2009	Sore arm, fever, body aches, chills, dizziness									Y	12/23/2008	12/23/2008	0		PUB	UNK	none	none	none			1						1	Chills; Dizziness; Pain; Pain in extremity; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0337633	01/16/2009	CT	64.0	64		F	01/16/2009	Information has been received from a case in litigation from a 64 year old female who on 29-OCT-2008 was vaccinated in the right arm with a dose of PNEUMOVAX 23 (lot # not provided). Concomitant therapy that same day included a vaccination of an unspecified flu vaccine (manufacturer and lot # not reported) into the patients left arm. The patient reported that she had been vaccinated with the pneumonia vaccine nine years ago and had no problems with it. The patient stated that she always had good luck with the flu vaccine and had only a slight flu reaction like a raised itchy red spot about a half dollar size 5 years ago. This time I had a totally rare experience with the vaccines. The patient reported that at the time of vaccination she felt a shock that very quickly went up the right arm through the right shoulder and to the top of the spine all the way down to the tip of the spine. It was ever so slight but I felt the reaction. The flu vaccine shot in the left arm was fine and had no swelling except for the normal ache of a needle shot. The patient reported that she went home and about an hour later began feeling flu like symptoms. The patient reported that she knew that was normal and just ignored the symptoms. She reported that as the hours passed from 10 A.M. to noon the morning of the injections, she noted that her right arm was hurting more than it was at the time of initial injection. She stated that she had trouble lifting the arm without having pain, so she rested and tried to not focus on it too much. The patient thought that the next day it would be fine. However by the noon that same day of the vaccinations, she reported that she felt like she had the flu. She reported that she rested and again thought that would be 100% fine the next day. She reported that by that evening, the patient had a lot of pain in the right arm in the area of the injection. The patient had to use the left arm to lift the right arm to move it to another position. The patient reported that at the time of the vaccination she told the nurse that the PNEUMOVAX 23 hurt much more than the flu shot. She stated that the administering nurse agreed that it usually does, so the patient decided to rest. The patient reported that when she went to bed that night, she had an awful lot of pain in the entire upper right arm and could not move the arm without the using the left had. She reported that she was awake most of the night in pain and took two extra strength acetaminophen tablets, which she reported did not help. She reported that the arm was very itchy and had a large rash about 12 long and 9 wide, the arm was swollen twice its size and very warm to the touch. She reported that she became very alarmed. She also reported that she had a severe headache. The patient reported that she took a shower and noticed red blotches on the right leg just below the calf. She stated that she had hives the diameter of 4 by 4 on the front lower and back lower leg just below the calf. She reported that her aunt then took her to the emergency room. The patient reported that she was seen by physician who said that she had a reaction from the pneumonia shot. The patient noted that the emergency room nurse noted the large rash, swelling and warmth of her skin on her arm. The patient reported that all her joints, muscles and bones hurt. She also reported that her abdomen was swollen and hurt and the lining of her abdomen was burning. She reported that her body was achy all over and her eyes and nose ran constantly. Additionally, she stated that she was in excruciating pain, had a light bluish color at the top of rash area, stiff neck, pressure in both ears, an odd taste in her mouth that was odd, felt lightheaded and dizzy. She stated that her throat felt like it was raspy and almost as if I was getting a sore throat. The patient reported that the physician prescribed her PERCOCET, BENADRYL and VISTARIL. The patient reported that she went home and could not eat. She reported that she drank some tea and ate some crackers, toast and water. She stated that she was very concerned about what was happening. She reported that she rested all day and again that night. She stated that when she awoke and looked at the arm area, the swelling had traveled from the elbow, all around the shoulder to 1/3rd down the back bone (scapular), that the color of the swollen area was all bluish with a raised rash and a very stiff neck. The patient returned to the emergency room. She reported that she was given intravenous fluids (NOS) and MOTRIN for the ever so constant headaches. She reported that she had CAT scan to view if he/she had further problems from the pneumonia injection (result not provided). She reported that at that time that she had poor balance, memory forgetfulness, especially where time was concerned. She reported that she was confused and had trouble concentrating on anything from time, reading and remembering. My balance was very unstable and was still not that good. She reported weight loss and an ongoing poor appetite. The patient stated that the pneumonia vaccine has exacerbated a small stroke that I had which has caused forgetfulness and poor balance. She also reported that she became depressed since 19-NOV-2008. She also reported that she had developed tremors (date not specified) during church and was very tired all the time. On an unspecified date she stated that she had developed sneezing, thick mucous and had been coughing for two days. Upon internal review the aggravation of the small stroke I have was determined to be an other medical event. Additional information has been requested.				Y					N	10/29/2008			Unknown	OTH	OTH			Vaccination adverse reaction; Stroke; Generalised raised red spots limbs		WAES0901USA00619	1						1	Abdominal distension; Abdominal pain; Arthralgia; Balance disorder; Bone pain; Condition aggravated; Confusional state; Cough; Decreased appetite; Depression; Disturbance in attention; Dizziness; Dysgeusia; Ear discomfort; Erythema; Fatigue; Headache; Influenza like illness; Injection site pain; Joint range of motion decreased; Lacrimation increased; Memory impairment; Musculoskeletal stiffness; Myalgia; Nausea; Oedema peripheral; Oropharyngeal pain; Pain; Pain in extremity; Pruritus; Rash; Rhinorrhoea; Skin discolouration; Skin warm; Sneezing; Tremor; Urticaria; Weight decreased	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~2~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0337674	01/16/2009	GA	8.0	8		F	01/16/2009	11/4 had varicella shot R arm.  11/5 developed redness & blisters on R arm below injection site- pt here 11/6/09									Y	01/14/2009	01/15/2009	1	None	PVT	PUB		UTI; Rx Septra suspension				1						1	Blister; Erythema	FLU3~SANOFI PASTEUR~42831AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0172X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0337690	01/16/2009	MN	44.0	44		F	01/09/2009	My left shoulder started pinching.  The pain progressed to point of doctor visit.  Am currently doing physical therapy for left shoulder.									Y	10/20/2008	11/24/2008	35		PUB	UNK		None	Allergic to Penicillin & Sulfa			1						1	Musculoskeletal pain	FLU3~SANOFI PASTEUR~U2798CA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337691	01/16/2009	MN	43.0	43		F	01/09/2009	Worst shot ever given- hurt immediately and for approx 4 to 5 days after.  Got really sick after for 4 days - puking etc.  Started noticing that arm aches all the time/area given is sore to touch-hard to lift above a certain height for last 2 months									N	10/30/2008	10/31/2008	1	None	OTH	OTH	High blood pressure meds; stomach meds	None	Amoxycillian /Penicillin/ Stomach Stufflon (medication); High blood pressure (in medication)			1						1	Immediate post-injection reaction; Injected limb mobility decreased; Malaise; Pain; Pain in extremity; Vomiting	FLU3~SANOFI PASTEUR~U2798CA~7+~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0338524	01/16/2009	MO	0.7			M	12/16/2008	A non-serious spontaneous report of administration to a seven-month-old has been received from a physician concerning a seven-month-old male who received FLUMIST on 01-Dec-2008. Medical history and concomitant medications were not reported. There was no adverse event reported with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. on 16-Dec-2008, 15 days after the patient received FLUMIST, the physician's nurse confirmed that there were no late-occurring adverse events reported.									Y	12/01/2008	12/01/2008	0		OTH	OTH	Concomitant drug(s) not reported				MEDI0007575	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500558P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0338525	01/16/2009	CT	4.0			M	12/03/2008	A non-serious spontaneous report administered expired FLUMIST was received from a nurse concerning a four-year-old male. The patient received FLUMIST on 02-Dec-2008. The patient was given FLUMIST that expired in December 2007. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1 customers not discarding product from the previous season and 2 product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 09-APR-2009: product complaint investigation results.									Y	12/02/2008	12/02/2008	0		OTH	OTH	Concomitant drug(s) not reported				MEDI0007579	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500490P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0338526	01/16/2009	KS	1.8			F	12/04/2008	A spontaneous non serious report of stuffy nose, fever, green mucus coming out of her nose and coughing was received from the patient's mother concerning a 21-month-old female patient subsequent to accidental exposure to FLUMIST. This case in submitted in accordance with post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history included a similar reaction when the mother's roommate received FLUMIST last year. Concomitant medications were not reported. The patient did not receive FLUMIST. On 01-Dec-2008, her father received FLUMIST. Twenty-four hours later, the patient developed stuffy nose, fever, and coughing. On 02-Dec-2008, the patient had green colored mucus coming from her nose. The events of stuffy nose, fever, and coughing were ongoing. Follow-up Information 23-APR-2009: No additional information available. Reported refused to be contacted.									U		12/02/2008			UNK	UNK			2007: Patient had similar reaction when the mother's roommate received FLUMIST		MEDI0007590	1						1	Accidental exposure; Cough; Nasal congestion; Nasal mucosal discolouration; Pyrexia; Secondary transmission	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0338527	01/16/2009	KY	1.59	1	.6	M	12/08/2008	A non-serious report given FLUMIST to 19-month-old was received from a doctor's medical assistant involving a 19-month-old male. On 14-Dec-2008 the patient received FLUMIST. On the same day, the patient received hepatitis B, DTap, PCV, IPV/OPV vaccines. The patient had no relevant medical history. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 month of age for FLUMIST.									Y	12/04/2008	12/04/2008	0		PVT	OTH					MEDI0007604	1						1	Inappropriate schedule of drug administration	DTAP~UNKNOWN MANUFACTURER~~3~UN~UN~DTAP (NO BRAND NAME)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500553P~1~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~UNKNOWN MANUFACTURER~~3~UN~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~3~UN~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0338528	01/16/2009	IN	0.9			M	12/24/2008	A non serious report of gave FLUMIST to an 11-month-old has been received from a registered nurse concerning an 11-month-old male. Medical history and concomitant medications were not reported, There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved, This case is admitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received on 24-Dec-2008 was incorporated into the narrative and included the patient's gender. The reporting nurse confirmed that there were no late-occurring adverse events.									Y	12/10/2008	12/10/2008	0		OTH	OTH					MEDI0007613	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500584P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0338529	01/16/2009	CA	4.0	4		M	12/10/2008	A non-serious report of administration of expired product has been received from a registered nurse concerning a four-year-old male who received FLUMIST on 15-Nov-2008. FLUMIST expired on 12-Nov-2008. Medical history and concomitant medications were not reported. There was no adverse event reported with this medication error; therefore, treatment and reporter/sponsor causality assessment's are not applicable, and the event is considered resolved. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. 01/05/09 On 05-Jan-2009, the reporting nurse confirmed that there were no late-occurring adverse events reported. 01/05/09 Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information received on 20-Mar-2009 included Product Complaint Investigation results.									Y	11/15/2008	11/15/2008	0		OTH	OTH	Concomitant drug(s) not reported				MEDI0007614	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0338530	01/16/2009	TN	0.6			U	12/11/2008	A non serious, spontaneous report of administration of FLUMIST to a seventh month-old was received from a nurse. There was no adverse event associated with the medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.									Y	12/11/2008	12/11/2008	0		OTH	OTH					MEDI0007622	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500548P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0338531	01/16/2009	GA	1.3			F	12/16/2008	A non serious, spontaneous report of gave expired FLUMIST to a three-year-old female patient was received from a medical assistant. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 moths of age for FLUMIST. This is in follow-up to report(s) previously submitted on 12/16/08. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 06-Jan-2009 and incorporated the narrative: no adverse event occurred. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	12/16/2008	12/16/2008	0		OTH	OTH	Concomitant Drug(s)  Not Reported				MEDI0007637	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500545P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0338532	01/16/2009	FL	4.0			M	12/19/2008	A non serious spontaneous report of influenza A, fatigue, fever, sore throat, and stomach ache has been received from a physician concerning a four-year-old male subsequent to FLUMIST. This case is submitted in accordance to a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's past medical history included an enterovirus on the 04-Nov (year unreported). The patient received FLUMIST 0.2ml intranasally for influenza vaccine on 22-Oct-2008. On 14-Dec-2008, the patient experienced fatigue, fever, a=sore throat, stomach ache, and was positive for Influenza A on 150Dec-2008, when tested with BIONEX rapid Influenza A&B test. On 15-Dec-2008, she had a negative rapid streptococcal test and a urinalysis revealed large ketones. The patient was treated with oseltamivir phosphate and was sent home to be followed up in one week. The events resolved on an unreported date in 2008.									Y	10/22/2008	12/14/2008	53	Influenza A, B, 12/15/08, influenza A, positive; Rapid Strep test, 12/15/08, negative; Urinalysis,12/15/08, Large Ketones	PVT	PVT			Enterovirus, 11/04, (unreported year)		MEDI0007658	1						1	Abdominal pain upper; Fatigue; Influenza; Influenza serology positive; Oropharyngeal pain; Pyrexia; Streptococcal identification test negative; Urine analysis abnormal; Urine ketone body present	FLUN3~MEDIMMUNE VACCINES, INC.~500551P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0338533	01/16/2009	CA	1.92	1	.9	F	12/19/2008	A non serious report of a child under two years of age who received FLUMIST was received from a registered nurse concerning a 23-month-old female. The patient's medical history wand concomitant medications were not reported. On 19-Dec-2008, the child was given FLUMIST. The patient's name was inadvertently entered in the clinic's schedule on 19-DEC-2008 to receive FLUMIST although she was still only 23 months old. The information regarding the patient's age was missed by both the clinic physician and the nurse-in-charge of the immunization. On 20-Dec-2008, the patient was brought back to the clinic for her scheduled baby follow-up. Her physical examinations were all normal and there was also no report of adverse event relating to FLUMIST vaccination. As of 12-Jan-2009, no report of delayed occurring adverse with this medication error, therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information was received on 12-Jan-2009 and incorporated in the narrative including the corrected date of FLUMIST vaccination as 19-Dec-2008 as well as reporter's confirmation that there was no delayed occurring adverse event.									Y	12/19/2008	12/19/2008	0		OTH	OTH	Concomitant Drug(s) Not Specified				MEDI0007660	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500585P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0338534	01/16/2009	WV	4.0	4		F	12/23/2008	A non serious report of administered expired FLUMIST was received from a registered nurse concerning a four-year-old female. Medical history and concomitant medications were not reported. On 22-Dec-2008, the patient received FLUMIST that expired on 10-Dec-2008. The physician was made ware of the incident and has decided not to redose FLUMIST. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments, are not applicable, and the event is considered resolved. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 month for FLUMIST.  This is in follow-up to report(s) previously submitted on 12/23/2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. On 08-Jan-2009, the reporting nurse confirmed that there were no late-occurring adverse events. Follow-up information received on 24-MAR-2009 included Product Complaint Investigation results.									Y	12/22/2008	12/22/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007662	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500545P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0338535	01/16/2009	MO	2.0	2	.9	F	12/23/2008	A non serious, spontaneous report of administration of expired product was received from a nurse concerning a two year-old female subsequent to FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. There are no events reported after follow-up. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 08-Jan-2009 and incorporated into the narrative follow-up outcome. Follow-up information was received on 07-Apr-2009: Product Complaint Investigation results.									Y	12/23/2008	12/23/2008	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0007667	1						1	Expired drug administered; Product quality issue	FLUN3~MEDIMMUNE VACCINES, INC.~500548P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0338536	01/16/2009	MI	3.2			F	12/29/2008	A non-serious report of administration of expired product was received from a registered nurse concerning a 38-month-old female. Neither medical history nor concomitant medications were reported. On 29-Dec-2008, two siblings, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of 23-Dec-2008. There was no adverse event associated with medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information was received on 10-Mar-2009 that no delayed adverse events resulted from this error. 3/25/2010 Based on the results of the investigation, the root cause fro the medication errors were caused by 1) customers not discarding product from the previous season and  2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 09-Apr-2009 product complaint investigation results.									Y	12/29/2008	12/29/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007674	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500550P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0338537	01/16/2009	MI	3.0			F	12/29/2008	A non-serious report of administered expired FLUMIST was received from a medical assistant concerning a 36-month-old female. FLUMIST, which expired on 25-Dec-2008, was administered on 26-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with a post-marketing commitment on accelerated reporting of 2 years to 59 months of age for FLUMIST. Based on the results on the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the prouduct expired. Additional information received on 03-Feb-2009 included Product Complaint Investigation results.									Y	12/26/2008	12/26/2008	0		PVT	OTH					MEDI0007683	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500551P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0338538	01/16/2009	MI	3.4			M	12/29/2008	A non-serious spontaneous report of expired FLUMIST given to this child was received from a certified medical assistant in a physician's office concerning a 48-month-old male. Neither medical history nor concomitant medications were reported. On 26-Dec-2008, two siblings, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of 25-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medications errors that occurred shortly after the product expired. Additional information was received on 03-Feb-2009: The reporter confirmed there were no delayed occurring adverse events. Follow-up information received on 24-Mar-2009 included Product Complaint Investigation results.									Y	12/26/2008	12/26/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007685	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500551P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0338994	01/17/2009	TX	60.0	60		M	01/07/2009	This case was reported by a pharmacist (also the subject) and described the occurrence of feeling woozy in a 60-year-old male subject who was vaccinated with FLULAVAL. On 9 October 2008 at 12:50 the subject received a dose of FLULAVAL (1 ml, unknown, left arm). On 9 October 2008, 1 hour after vaccination with FLULAVAL the subject experienced feeling woozy, headache and overdose. The pharmacist reported that he received FLULAVAL at work and was given 1 ml instead of 0.5 ml. At the time of reporting the events were unresolved. Follow-up received on 31 October 2008 indicated that the events were just temporary and passed soon. The events were resolved at the time of follow-up. No additional information was reported.									Y	10/09/2008	10/09/2008	0	UNK	OTH	OTH		Unknown	In follow-up, it was reported by the subject that he received the flu vaccine each year. Previous reactions to flu vaccines were not reported if any.		A0752844A	1						1	Dizziness; Headache; Incorrect dose administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0337622	01/18/2009	NJ	48.0	48		F	01/18/2009	Patient suffered Severe back pain, Tingling of lower extremities, Loss of sensation, Band like feeling around torsoe, Unable to stand, resulted in permanent paralysis, Bladder disfunction, Bowel disfunction, Loss of balance, Motor Skills and has since been diagnosed with breast cancer and diabetes. Final discharge diagnosis as Transverse Myelitis at the T-4 - T-6 level. Treatment included Prednisone, full course IVIG.  2/2/09 MR received for DOS 12/19-30/2005 with D/C DX:  Transverse Myelitis.  Mild depression.  Anxiety.  Hx of breast cyst.  Hx of removal of L facial cyst.  DM Type II.  Pt presented to ER with c/o decreasing sensation in the lower extremities with inability to walk. Neuro exam (+) for decreased sensation from the waist down, decreased strength-0/5 in both legs, decreased reflexes and (+) Babinski.  Unable to move legs  due to ascending motor paralysis. Tx with IVIG.  Transferred to rehab.				Y	Y	14	Y	Y	N	11/22/2005	12/19/2005	27	Labs and Diagnostics:  Head CT (-). ANA (+).  CSF cell count WNL except (+) RBCs. CSF glucose 133. Blood glucoses 180's to mid 200s. Myelin basic protein (-).  No oligoclonal bands.  MRI spine (-). EMG/NCS WNL. HSV Ab (+). CSF cx (-).	UNK	UNK	Paxil, Kolonipin	None. 2/18/09 OV from 11/22/05 received from PCP. Pt reportedly doing great, 20 lb wt loss, exercising more.	Anxiety. PMH: Anxiety/? depression. L breast cyst-removed. L facial cyst-removed. Allergic to Betadine			1						1	Back pain; Balance disorder; Bladder disorder; Blood product transfusion; Breast cancer; Diabetes mellitus; Dysstasia; Intestinal functional disorder; Motor dysfunction; Myelitis transverse; Paraesthesia; Paralysis; Sensory loss	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~2~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0337623	01/18/2009	CO	66.0	66		F	01/18/2009	lower leg,ankle,and foot were swollen. Painful hives on ankle, and on top of foot. smaller hives across lower back,on back of neck,and top of head.the muscles in my foot and leg were in a tight cramp,the big toe was to painful to even lay on the bed. it is still extremly painful when I try to sleep at night.  the muscles in my leg are still tight and painfull that also makes it hard for me to get sleep.   my back started hurting so bad it was hard to walk.   I guess that may have been because of no sleep.     I did not go to the Doctor because I was in to much pain to even move around my house and when I called the clinic to see if there was something I could do the nurse acted like I was crazy,she said I could,t have hives unless they were all over my body,well I still have the marks from them, they were like burns on my skin.    It seemes like what ever gave me the bad reaction just went after the arthritis in my body.									Y	12/22/2008	12/24/2008	2	none	UNK	UNK	Neurontin	None	None	none~ ()~~0.00~Patient		1						1	Back pain; Gait disturbance; Insomnia; Muscle spasms; Oedema peripheral; Pain; Urticaria	FLU3~PFIZER\WYETH~~UNK~~~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0337635	01/19/2009	TX	41.0	41		M	01/19/2009	30 minutes after vaccine developed chills, progressed to numbness, tingling of lips and palate, increased BP and heart rate.									Y	01/19/2009	01/19/2009	0		PUB	UNK	none	none	none	fever, chills, SOB, pallor~Smallpox (no brand name)~UN~35.30~In Patient		1						1	Blood pressure increased; Chills; Heart rate increased; Hypoaesthesia; Paraesthesia	FLU3~SANOFI PASTEUR~c2763aa~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337640	01/19/2009	AZ	5.0	5		F	01/19/2009	Temperature 104.1, heavy chest congestion, wet hacking cough, chills, sweaty. 3:00 AM 5 ml Childrens tylenol 7:00 AM temp 103.9 7.5 ml childrens motrim. broke the fever, low grade fever persisted the next 12 hours. Flushed skin tiny red dots from 7:00 Am for 12 hours. Cough went away Monday AM				Y					Y	01/16/2009	01/17/2009	1		UNK	UNK	none	none	omnicef, peanuts, birth mark left forward(dime size), Medical conditions: Crebral palsy			1						1	Chills; Cough; Flushing; Hyperhidrosis; Pyrexia; Rash erythematous; Upper respiratory tract congestion	FLUX~UNKNOWN MANUFACTURER~un~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~un~1~IM~RA~HEP A (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~un~UNK~IM~LA~VARICELLA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0249747	01/20/2009		40.0			M	01/14/2009	This serious case was received via a search of the scientific literature on 12 January 2009. A 40-year-old male serviceman received the following vaccinations on an unknown day in 2005 in preparation for active military duty: smallpox vaccine, typhoid vaccine, hepatitis A vaccine, (manufacturers not reported) and FLUMIST (MedImmune Vaccines). Lot numbers, and site of administration were not reported. The patient had received a primary smallpox vaccination in 1986, 19 years earlier, when he joined the military. He had no reported medical history. Five days post-vaccination, the patient developed photophobia. He was hospitalized eight days post-vaccination, and upon admission was noted to be confused and agitated. Physical examination showed a temperature of 38.2 degrees Celsius, increased upper extremity tone, low-frequency tremor, and a Glasgow coma score of 10. A rash was noted at the site of vaccination. Lumbar puncture revealed an opening pressure of 15 cm of water, a protein concentration of 122 mg/dL, and a WBC count of 294 cells/uL, with 76% lymphocytes and 24% neutrophils. An electroencephalogram revealed diffuse theta-frequency slowing without epileptiform discharges; brain MRI showed no significant abnormalities. The patient was initially treated with ACYCLOVIR, and then PHENYTOIN when he developed generalized seizures. A repeat lumbar puncture 11 days post-vaccination showed an opening pressure of 19 cm of water, a protein concentration of 95 mg/dL, and a WBC count of 137 cell/uL, with 89% lymphocytes, 1% neutrophils, and 10% monocytes. His status improved gradually, and he was discharged 16 days post-vaccination. At the time of discharge, he exhibited residual deficits in short-term memory, coordination, and balance. Serum and CSF samples sent to the Poxvirus Program at the CDC were negative for orthopox virus DNA, and IgM antibody was undetectable. Vaccinia-specific IgG antibody was detected in both serum and CSF. Results of extensive testing for infectious agents were negative. According to the authors, the five-day lapse to onset of neurological symptoms after secondary smallpox vaccination and lack of evidence of direct CNS infection suggest an autoimmune response to vaccination. In conclusion, it was noted that the patient in this report meets the surveillance case definition for probably PVE(postvaccinia encephalitis).					Y	0			N				9 days post-vaccination: Lumbar puncture revealed an opening pressure of 15 cm of water, a protein concentration of 122 mg/dL, and a WBC count of 294 cells/uL, with 76% lymphocytes and 24% neutrophils. An electroencephalogram revealed diffuse theta-frequency slowing without epileptiform discharges; brain MRI showed no significant abnormalities. 11 days post-vaccination: Repeat lumbar puncture showed an opening pressure of 19 cm of water, a protein concentration of 95 mg/dL, and a WBC count of 137 cell/uL, with 89% lymphocytes, 1% neutrophils, and 10% monocytes. Negative for alternative infectious agent: Adenovirus CSF PCR, California and eastern equine encephalitis virus serum antibody immunofluorescence assay, Ehrlichia chaffeenis IgG antibody IFA and whole blood PCR, enterovirus CSF PCR, Epstein-Barr virus CSF PCR, Herpes simplex virus CSF PCR, human herpes virus-6 CSF PCR, parvovirus B-19 serum IgM-negative EIA, Rickettsia rickettsii serum IgG antibody, IEA, St. Louis encephalitis virus serum IgM and IFA antibody EIA, West Nile virus serum IgM EIA, and western equine encephalomyelitis serum antibody IFA. Serum and CSF samples sent to the Poxvirus Program at the CDC were negative for orthopox virus DNA, and IgM antibody was undetectable. Vaccinia-specific IgG antibody was detected in both serum and CSF.	MIL	MIL			None reported.	No adverse reaction~Smallpox (no brand name)~1~0.00~In Patient	200900093	1						2	Agitation; Amnesia; Balance disorder; CSF culture negative; CSF lymphocyte count increased; CSF monocyte count decreased; CSF neutrophil count increased; CSF protein increased; CSF white blood cell count increased; Confusional state; Convulsion; Coordination abnormal; Culture negative; Electroencephalogram abnormal; Encephalitis post immunisation; Hypertonia; Injection site rash; Lumbar puncture abnormal; Nuclear magnetic resonance imaging brain normal; Photophobia; Polymerase chain reaction; Pyrexia; Tremor; Virus serology test positive	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~2|SMALL~UNKNOWN MANUFACTURER~~2~OT~UN~SMALLPOX (NO BRAND NAME)~2|TYP~UNKNOWN MANUFACTURER~~UNK~UN~UN~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0337669	01/20/2009	MI	1.0	1	.0	M	01/19/2009	Pt given HIB #4; PREVNAR #4; Hepatitis A #1; MMR #1; Varicella #1 and Influenza #1 on 11-17-08. Pt presented one week later barely breathing; flacid and unresponsive to verbal-painful stimuli at 1755-transferred-died at local hospital a couple of hours later.  2/12/09 PCP and hospital records received from FDA.  Pt with mild fever 11/24/08 put down to nap. Ptfound  to be diaphoretic, limp, minimally breathing and non-interactive in crib. Upon arrival of EMS pt noted to be unresponsive to stim, satring with no blink response, pulse 160, RR 32 with rhonchi bilaterally R>L.  Dx with severe croup at local hospital with transport planned to higher level of care. In ER unresponsive in severe respiratory distress, skin mottled, O2 sats 80s-90s on pale toes. Arrived to transfer hospital unresposive to pain, lethargic, initially flaccid then posturing, (+) cervical lymphadenopathy, resp distress with stridor and rhonchi- intubated. Impression-  Respiratory Failure. Cardiac arrest.  CPR unsuccesful.    3/25/09 Autopsy report received with COD: Community Acquired Pneumonia. Manner of Death:  natural.  Final DX: 1) Acute hemorrhage pneumonia, multifocal, community acquired- a) Diffusely firm, edematous and hemorrhagic lungs, bilaterally. b) Histologic exam confirms purulent multifocal pneumonia.   2)  Moderate Cerebral Edema.  3)  Serous Pleural and Peritoneal Effusions.	Y	11/24/2008							N	11/17/2008	11/24/2008	7	Labs and Diagnostics:  CXR (+) for R pneumpthorax, pneumomediastinum, and probable L pneumothorax.	PVT	PUB	None	None - normal	? slight allergy 6-10-08; Hx otitis media . PMH: PCP records reveal normal childhood illnesses (OM, URI, bronchits) in 1st yr of life. Excessive wt gain noted at 3 months.			1						1	Death; Dyspnoea; Hypotonia; Unresponsive to stimuli	FLU3~SANOFI PASTEUR~UT2788FA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB213AA~1~IM~LL~HEP A (HAVRIX)~1|HIBV~SANOFI PASTEUR~UF222AA~4~IM~LL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0807U~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C50457~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1517U~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Results in Death	Influenza
0337677	01/20/2009	GA	0.37	0	.4	M	01/08/2009	4 month old male, received shots by mistake; Hep A (HAV) and FLUZONE. No adverse reaction occurred.									U	01/08/2009				PVT	PUB		None	None			1						1	No adverse event; Wrong drug administered	FLU3~SANOFI PASTEUR~UT2799FA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB262AA~1~IM~RL~HEP A (HAVRIX)~1	USA		Influenza
0337681	01/20/2009	NJ	0.9	0	.9	M	01/19/2009	Localized redness, lump, tenderness at right thigh. Fever 99-102.6. Vomiting x 1 on 1/14/09. Irritable and cranky. Treated with TYLENOL-MOTRIN. Symptoms started 1/14/09.									Y	01/13/2009	01/14/2009	1	None	PVT	PUB	None	None	None			1						1	Injection site erythema; Injection site mass; Injection site pain; Irritability; Pyrexia; Vomiting	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B066AA~3~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2839AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF521AA~3~IM~LL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~A1060~3~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~C87310~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0337682	01/20/2009	OR	80.0	80		F	01/19/2009	Pt complained of pain in muscle around site of injection within days of receiving vaccine.  The pain has radiated up and down arm, has affected sleep and range of motion.  Has been under physician care for this problem.				Y					N	09/30/2008	10/01/2008	1		OTH	PVT		None listed	Unknown; Penicillin; Sulfa; Allergic to bees			1						1	Injected limb mobility decreased; Injection site pain; Myalgia; Pain in extremity; Sleep disorder; Pain in extremity	FLU3~SANOFI PASTEUR~U2771AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2771AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0337683	01/20/2009	OR	53.0	53		F	01/11/2009	1st attempt to administer dose: Unable to get plunger down (resistance) so gave 1/2 dose same arm similar area and was able to give dose. Pt stated her arm hurts for 2 months after Flu shot and usually pain resolved but not with this dose. Arm weak and painful.									N	10/01/2008	10/01/2008	0	Dr doing MRI of deltoid to see cause of pain and weakness.	OTH	PVT	Albuterol, ADVAIR, Spiriva, Furosemide, Alprazolam		Asthma; hypertension			1						1	Muscular weakness; Nuclear magnetic resonance imaging; Pain in extremity	FLU3~SANOFI PASTEUR~U2742AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337684	01/20/2009	CA	42.0	42		F	01/19/2009	Lymph Node swelling									Y	12/24/2008	12/30/2008	6	ESR-22; neutrophils (low)	PUB	PVT	METFORMIN 500mg qd	Diabetes	Diabetes			1						1	Lymphadenopathy; Neutrophil count decreased; Red blood cell sedimentation rate increased	FLU3~SANOFI PASTEUR~U2802AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337704	01/20/2009		54.0	54		M	01/20/2009	Within a few hours after immunization with influenza in the left arm the patient started to experience pain to the slightest touch in the left arm between the deltoid to the elbow.  Mostly localized around the triceps muscle.  Has continued to experience extreme sensitivity to touch over the area with extreme pain.  No swelling or other evidence of inflammation during the course of the symptoms.				Y					U	01/08/2009	01/08/2009	0	CT scan left upper arm 11 days after vaccination was negative	MIL	MIL	HCTZ, lisinopril, zocor	None	HTN, DM, HLP			1						1	Computerised tomogram normal; Hyperaesthesia; Pain in extremity	FLU3~SANOFI PASTEUR~U2833AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0337708	01/20/2009	PA	20.0	20		F	01/20/2009	Client given dose of adult hep A. Client was 2 - 3 mos pregnant at time dose given. Client has not reported an adverse reaction.									U	01/13/2009				PUB	PUB	prenatal vitamins	client pregnant				1						1	Drug exposure during pregnancy	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89976~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB251BA~2~IM~RA~HEP A (HAVRIX)~1	USA		Influenza
0337709	01/20/2009	MI	64.0	63		M	12/30/2008	PATIENT CAME INTO OFFICE ON 10-11-2008 DESCRIBING COMPLAINT OF COUGH, SLIGHT SWELLING AND DIFFICULTY SWALLOWING AFTER RECEIVING FLU SHOT ON 10-10-2008.  THE SYMPTOMS STARTED WITHIN A FEW HOURS OF RECEIVING HIS FLU SHOT. PATIENT STATES HE TOOK AN OVER-THE-COUNTER ANTIHISTAMINE AND REPORTS FEELING BETTER AT APPT ON 10-11-08.									Y	10/10/2008	10/10/2008	0		PVT	PVT		NONE	ZOCOR (MYALGIA), LISINOPRIL (DIZZY), LORATIDINE (DIZZY), VIAGRA (GI INTOLERANCE)			1						1	Cough; Dysphagia; Swelling	FLU3~SANOFI PASTEUR~U2757AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337724	01/20/2009	MA	47.0	47		M	01/20/2009	A week after I received my flu shot I fell ill with a severe flu?/viral infection? that took me six weeks to recover from. Symptoms: On the first day, severe dizziness (could not get out of bed), strong headache, nausea, low-grade fever, fast pulse, restlessness. Dizziness better after first day. Low-grade fever continued for a week. Outbreak of flu?/viral infection? may or may not be connected to flu-shot. At the time I took the flu shot I did not show any symptoms of being unwell. I have been having a flu shot for over ten years and have never shown a reaction. PS: I don't know the name of the vaccine manufacturer health center used.									Y	12/09/2008	12/18/2008	9	none	UNK	UNK	none	none	none			1						1	Activities of daily living impaired; Dizziness; Headache; Heart rate increased; Influenza like illness; Nausea; No reaction on previous exposure to drug; Pyrexia; Restlessness	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0337737	01/20/2009	FL	15.0	15		M	01/05/2009	Seizures X 2 1-5-09.  First time seizures.  1/23/09 Reviewed hospital medical records of 1/5-1/6/2009. FINAL DX: new onset seizures Records reveal patient experienced tingling in feet, stiffening movements while at school & had generalized convulsion, apnea, jaw clenching, loss of consciousness & postictal behavior.  Had witnessed seizure in ER.  Neuro consult done.  Tx w/meds & no further seizures while hospitalized.  D/C to home on continued oral meds.				Y	Y	1			Y	12/29/2008	01/05/2009	7	CT Brain, OK  LABS: CPK 1085(H).  CK-MB 2.7(N).  LFTs WNL.  Magnesium 2.1.  CT head WNL.  MRI brain revealed only mild sinus disease.  EEG abnormal. CXR WNL.  EKG borderline abnormal.	MIL	OTH		None	None			1						1	Computerised tomogram normal; Convulsion; Scan brain	FLU3~SANOFI PASTEUR~U2941BA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB329BA~UNK~UN~UN~HEP A (HAVRIX)~1	USA	Hospitalisation	Influenza
0337739	01/20/2009	PA	16.0	16		F	01/15/2009	Arm Pain- Contests Rash										01/12/2009				PVT	PVT		None				1						1	Pain in extremity; Rash; Respiratory tract congestion	FLU3~SANOFI PASTEUR~U2840AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337751	01/20/2009	WA	69.0	69		F	11/29/2008	Redness, induration, just below deltoid area L arm began 24 hrs after injections of influenza & pneumonia vaccine.  Achey &  aneretis at onset, + 48 hrs area of redness warm & mildly tender at onset.									Y	11/26/2008	11/26/2008	0		PVT	UNK	SECLIST	Cholesterol Check up only	None			1						1	Anorexia; Erythema; Induration; Pain; Skin warm; Tenderness	FLU3~SANOFI PASTEUR~U2747AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1076X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0337753	01/20/2009	MD	15.0	15		M	01/14/2009	No adverse symptoms known-3rd MMR given.									U	01/14/2009				OTH	PUB			ADHD; neuro fibromatosis, type I			1						1	Inappropriate schedule of drug administration; No adverse event	FLU3~SANOFI PASTEUR~U2839AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1369X~3~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1283X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0337756	01/20/2009	NE	57.0	57		M	12/15/2008	7pm 12/14/08 received flu shot 10pm 12/14/08 throat started feeling tight and full. Also had red, watery eyes and swelling of the eye lids. Treatment, OTC BENADRYL 50mg.										12/14/2008	12/14/2008	0	None	PVT	PVT			None			1						1	Eyelid oedema; Lacrimation increased; Ocular hyperaemia; Throat tightness	FLU3~SANOFI PASTEUR~U2766AA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337759	01/20/2009	WI	1.3	1	.3	M	01/05/2009	Patient developed fever, irritability and rash on 12-31-08. Parent took child to ER. ER MD noted fever and maculopapular rash diagnosed viral exanthem or possible chicken pox.				Y					Y	12/22/2008	12/31/2008	9	None	PUB	PUB			None			1						1	Irritability; Pyrexia; Rash maculo-papular; Viral skin infection	FLU3~SANOFI PASTEUR~UT2788GA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1083X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C52997~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0972X~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0338580	01/20/2009	TX	14.0	14		F	01/16/2009	Information has been received for the Merck Pregnancy Registry for GARDASIL from a Registered Nurse concerning a 14 year old female patient who on 05-DEC-2008 was vaccinated with first dose of GARDASIL (Lot # not provided).  Concomitant therapy included Diphtheria Toxoid (+) PERTUSSIS ACELLULAR vaccine (unspecified) (+) TETANUS TOXOID (manufacturer unspecified), FLUMIST and MENACTRA .  After the patient received the vaccines she went to the Emergency Room with a fever of 102.6F and vomiting.  It was at this time she discovered she was about 8 to 12 weeks pregnant.  Additional information has been requested. Thisi s in follow-up to report (s) previously submitted on 1/16/2009. Additional information has been received from a prengnancy registry for GARDASIL from a registered nurse who reported that a patient on 10-Dec-2008; the patient was vaccianted with the first dose of GARDASIL (lot # 661046/0381X). Concomitent medication included an unspecified psychiatric medication and DEPO PROVEN. Additional information has been requested.				Y					U	12/05/2008	12/05/2008	0	body temp - fever of 102.6F	OTH	OTH	medroxyprogesterone acetate	Pregnancy NOS (LMP = Unknown)			WAES0812USA02787	1						1	Drug exposure during pregnancy; Pyrexia; Vomiting	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0361X~1~UN~UN~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0337774	01/21/2009	DC	2.0	2	.4	M	01/21/2009	PT RECEIVED EXPIRED FLUMIST DURING WELL CHILD CHECK. NO REPORTED ADVERSE EVENTS TO DATE OF COMPLETING REPORT.									U	12/22/2008			NONE ORDERED, HOWEVER CONTACTED MANUFACTURER FOR STABILITY STUDIES AND ADDITIONAL INFORMATION  ON USE OF EXPIRED FLUMIST IN CLIENTS.	PUB	PUB	PRESCRIBED DURING VIST SALINE NASAL SOLUTION  0.65%, NASALLY, TWO DROPS EACH NOSTRIL AS NEEDED.	VIRAL INFECTION 079.99	DENIES	N/A~ ()~NULL~~In Patient|N/A~ ()~NULL~~In Sibling1|N/A~ ()~NULL~~In Sibling2		1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500548P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0337775	01/21/2009	DC	2.0	2	.0	F	01/21/2009	PT RECEIVED EXPIRED FLUMIST DURING WELL CHILD CHECK.  NO REPORTED ADVERSE EVENTS TO DATE OF CMOMPLETING REPORT.									U	12/29/2008			NONE ORDERED.  HOWEVER, CONTACTED MEDIMMUNE FOR STABILITY STUDIES AND ADDITIONAL INFORMATION ON EXPIRED FLUMIST.	PUB	PUB	CHILDREN'S TYLENOL 160/5ML	OTITIS MEDIA 382.9; GENU VALGUM 736.41	DENIES	N/A~ ()~NULL~~In Patient|N/A~ ()~NULL~~In Sibling1|N/A~ ()~NULL~~In Sibling2		1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500548P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB291C~1~IM~LA~HEP A (HAVRIX)~1	USA		Influenza
0337780	01/21/2009	TX	29.0	29		M	01/21/2009	16 Jan 09 arms were sore. 17 Jan 09 felt conjested. 18 Jan 09 more conjested 19 Jan 09 felt conjested and run down.  20 Jan had conjestion fever weakness fatigue dyspnea and joint pain, and went to the ER that night.				Y						01/16/2009	01/19/2009	3		MIL	MIL	NO	NO	PCN			1						1	Arthralgia; Asthenia; Dyspnoea; Fatigue; Pain in extremity; Pyrexia; Respiratory tract congestion	ANTH~UNKNOWN MANUFACTURER~FAV141~1~IM~LA~ANTHRAX (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~aflla197aa~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0337784	01/21/2009	NJ	3.0	3		F	01/21/2009	Child received the Flu vaccine between 9am & 10:30AM left the building with her mother and in the parking lot c/o being itchy and scratchy all over inside and out, even the mouth. Mother gave benedryl which she always carries and she got better within 20-30min. Mother stated no allergies, including eggs except bug bites. The father however has severe allergies to many things and she knows what an allergic reaction is. She called her PCP and he was going to note it in her chart so she does not get another Flu shot.									Y	01/20/2009	01/20/2009	0		PUB	PVT	No	No	None	No~ ()~NULL~~In Patient		1						1	Pruritus generalised	FLU3~SANOFI PASTEUR~U2792AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337787	01/21/2009	DC	4.0	4		F	01/21/2009	EXPIRED FLUMIST GIVEN TO CHILD DURING WELL CHILD EXAM.  NO REPORTED ADVERSE EVENTS TO DATE OF COMPLETING VAERS.									U	12/23/2008			NONE ORDERED, HOWEVER, CONTACTED MEDIMMUNE MFR.  FOR ADDITIONAL INFORMATION ON STABILITY STUDIES ON EXPIRED FLUMIST IN CLIENTS.	PUB	PUB	N/A	n/a	ventricular sept defect 745.4	n/a~ ()~NULL~~In Patient|n/a~ ()~NULL~~In Sibling1|n/a~ ()~NULL~~In Sibling2		1						1	Expired drug administered	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B103BC~1~IM~LA~DTAP + IPV (KINRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500548P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~MERCK & CO. INC.~0289U~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1531X~UNK~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0337789	01/21/2009	FL	47.0	47		F	01/21/2009	Approximately 12 hours after vaccination; an onset of myoclonus seizures began.  During the first hour, as many as 16.  This continued from 10/15/08 through 10/19/08 when primary care on call contacted.  When arrived at his office on 10/20/08, sent to hospital where I remained for the next 3 days.  I still continue to be treated for the siezures with medication.  They have lesssened in severity and frequency but have not stopped as of yet.2/6/09-records received-presented on 10/20/08 with C/O twitching sensation in neck began 5 days ago and then 2 days ago developed episode of soliatry twitch and sudden jerking movements while walking and became disoriented and confused. MD informed patient to discontinue Lyrica, however twitiching and confusion returned. Impression:seizure like activity. Twitching. 2/13/09-records receive for DOS 10/20-10/21/08-neurology consult:anxious and high strung appearing and exam WNL. Impression, abnormal involuntary movements, perhaps myoclonic jerks versus ballistic movements verus seizures.  Follow-up: Still continue to have myoclonic jerks. Still under neurologist care and haven't been able to work since June '09 when doctors had exhausted all medication trials; none of which have been successful in controlling the symptoms.					Y	3			N	10/15/2008	10/15/2008	0	myoclous seizures; CT scans, MRI, full body X-ray, eeg; nerve conduction test (pending 1/23/08) 2/6/09-records received-CBC and CRP normal, urinalysis mild positive leukocyte esterase. EKG normal sinus rhythm. CT head normal. EEG: normal	UNK	UNK		None	None 2/6/09-records received-PMH: fibromyalgia, hyperlipidemia, chronic pain syndrome, pericarditis. Recent uterine ablation and D/T/C. Allergic to amoxicillin, sulfa, erythromycin and doxycycline.	None~ ()~~0.00~Patient		1						1	Convulsion; Impaired work ability; Myoclonus; Nerve conduction studies; Nuclear magnetic resonance imaging; X-ray	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89973~UNK~ID~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0337800	01/21/2009	VA	50.0	50		F	01/10/2009	Fever developed; Right arm red, swollen, hot from upper deltoid to mid humerus- started KEFLUX & ROCEPLIN 2gm 1mx 3 days -> improvement is WBC, SXS, arm redness & fever									Y	01/07/2009	01/08/2009	1	CBC; WBC 19.7	PVT	PVT	Allergy ZITHROMAX - given 1/7 FORURX	UR1	Allergic rhinitis.			1						1	Erythema; Full blood count; Oedema peripheral; Pyrexia; Skin warm; White blood cell count increased	FLU3~SANOFI PASTEUR~U2772AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0870X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0337802	01/21/2009	TX				M	01/21/2009	Patient reported a lot of pain in left arm and couldn't even sleep on it. The next morning he thought he was blacking out. Left message on patient's answering machine to see how he was doing.									Y	01/20/2009	01/20/2009	0		OTH	PVT	HYTRIN; MOBIC; MEDROL; (p/u at time of vacc)	Inflammation; HTN	None			1						1	Loss of consciousness; Pain in extremity; Sleep disorder	FLU3~SANOFI PASTEUR~U2761AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337808	01/21/2009	PA	0.59	0	.6	M	01/21/2009	Child received PENTACEL, HEP B, PREVNAR, ROTAVIRUS & flu vaccines, instead of PEDIARIX, HIB, PREVNAR, ROTAVIRUS & flu vaccines.  No adverse reaction or treatment necessary.									Y	01/21/2009	01/21/2009	0		PVT	PUB	None	None	NKDA			1						1	No adverse event; Wrong drug administered	DTAPIPVHIB~SANOFI PASTEUR~C3240AA~3~IM~UN~DTAP + IPV + HIB (PENTACEL)~1|H5N1~SANOFI PASTEUR~UT2792DA~1~IM~UN~INFLUENZA (SEASONAL) (PANDEMIC FLU VACCINE (H5N1))~1|HEP~MERCK & CO. INC.~0726X~3~IM~UN~HEP B (RECOMBIVAX HB)~1|PNC~PFIZER\WYETH~DO5870~3~IM~UN~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1358X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0337823	01/21/2009	PA	81.0	81		F	01/21/2009	Patient lips were swelling. Patient was going to call primary doctor. Patient called me on Sunday 1/18/2009 in the afternoon. Patient did receive other vaccines a few days after getting here.									U	01/14/2009	01/18/2009	4		OTH	OTH	MARLME; ZPAK; CHERUTUSSIN					1						1	Lip swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881176P~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~08030~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0337832	01/21/2009	MA	5.0	5		F	12/05/2008	7x6cm area erythema, warm, tender, slightly hard, Left deltoid. 2 days s/p immunization with DTap, flu IM and polio SC in left arm.									Y	12/03/2008	12/04/2008	1		PVT	UNK		None	None			1						1	Erythema; Induration; Skin warm; Tenderness	DTAP~SANOFI PASTEUR~U2471AA~5~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2760AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0474~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0915X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0513X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0337972	01/22/2009	CA	46.0	46		F	01/22/2009	I have had pain in my Deltoid area the entire muscle since 11/05/09. I have had itching in that area as well as in the back of the shoulder.I have pain all the way down the arm precisley over knuckle of the index finger of the left hand. The hand is sometimes numb and tingling in the palm. Movement is slightly limited in the hand and arm. I am just now reporting because I had believed the soreness was just the regular reaction but I still have the imprint of the Bandaid on my arm from placement on 11/05/08 and the injection site just healed as well. I tried to explain that to the RNP that examined me but she was adamant that the flu shot could not cause the kind of reaction so she refused to listen. I think the virus was very strong and may be still culminating. My arm is aching right now as I type and the left index finger is where the sharpest pain is felt.									U	11/05/2008	11/05/2008	0		PUB	PUB	None	No Illness at time of Vaccination no illness prior to Vaccination. No preivious injury to neck,shoulder,arm or hand prior to vaccination.	NONE	NONE~ ()~NULL~~In Patient		1						1	Hypoaesthesia; Injected limb mobility decreased; Injection site pain; Injection site pruritus; Pain in extremity; Paraesthesia	FLU3~SANOFI PASTEUR~U2744AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337973	01/22/2009	CA	25.0	25		F	01/22/2009	On 15Jan2009, pt was administered the Influenza vaccine, Flulaval, instead of Afluria (approved for the pregnant populaton).									U	01/15/2009			None	MIL	MIL			Pt is pregnant- 33+3 weeks			1						1	Drug exposure during pregnancy; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0337974	01/22/2009	NC	54.0	54		F	01/22/2009	The 2 nights after the inject I was very uncomfortable and wakeful. The third day, I began noticing a soreness in my left breast which during the next several days became much worse. It was a extremely painful searing pain that occured with touch including clothing, turning over in bed. Got worse lasting 2 weeks+.				Y					U	12/10/2008	12/10/2008	0	Went to family chiropractor for adjustment and also to ob/gyn for breast exam	UNK	UNK						1						1	Breast pain; Discomfort; Insomnia	FLU3~SANOFI PASTEUR~AFLLA166AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0337977	01/22/2009	WA	16.0	16		F	01/22/2009	dizziness, hot flushing, sweating, blurry vision 5 minutes after vaccination.  Pt did not pass out but did fall to ground.  Pt felt better immediately upon being placed flat on ground (pt was also placed in trendelenberg position).  Pt had not eaten prior to vaccination.  Staff gave pt water & cookies & pt able to recover s incident.									Y	01/22/2009	01/22/2009	0		PVT	PUB		none.				1						1	Dizziness; Fall; Hot flush; Hyperhidrosis; Vision blurred	FLU3~SANOFI PASTEUR~U2829AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1968U~2~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0337981	01/22/2009	MN	11.0	11		F	01/22/2009	Adolescent became lightheaded then fainted several minutes after receiving immunizations. LOC approx 1 min. and color pale. Remained nauseous and lightheaded 10 mins. Walked on own to parking lot accompanied by mother and nurse. Mother called 2 days later and stated adolescent fine after arriving home.									Y	12/31/2008	12/31/2008	0		PUB	PUB						1						1	Dizziness; Loss of consciousness; Nausea; Pallor; Syncope	FLU3~SANOFI PASTEUR~2810AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0525U~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2661AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~033BA~1~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0337983	01/22/2009	SC	61.0	61		M	01/22/2009	In the week following the vaccination, patient states he felt very tired.  In the second week, he had a sore throat.  In the third week he had a cough, nasal congestion, and other flu-like aches.  In the fourth week following vaccination, he developed mild bronchitis symptoms.  After about six weeks, he recovered.									Y	11/05/2008	11/07/2008	2	none	PUB	PUB		none			SC0903	1						1	Bronchitis; Cough; Fatigue; Influenza like illness; Nasal congestion; Oropharyngeal pain; Pain	FLU3~SANOFI PASTEUR~U2828AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337988	01/22/2009	NH	0.6	0	.6	M	01/22/2009	Neck: normal, supple, no lymphadenopathy, no meningeal signs.  Respiratory exam: normal, no intercostal retractions, movements symmetrical, no wheezes or rhonchi.  Heart exam: normal, pink, no thrill or palpable murmurs, no displacement of PMI, S1, S2, no murmur, rub, or gallop.  Abdomen: normal, benign, no masses, bowel sounds normal.  Skin exam: see above.  Morbilliform rash on trunk>extremities>face, but diffuse, symmetric.  Not rough, no hives.  Minor diagnosis of viral exanthema: enteroviral-like, but wrong season.  D/W mom.  Observe.  Mom advised to call if symptoms worsen, fail to improve, or new symptoms develop.  R/o vaccine reaction: VAERS form completed.									Y	01/19/2009	01/20/2009	1	None	PUB	UNK	Zantac	None				1						1	Rash morbilliform; Viral skin infection	FLU3~SANOFI PASTEUR~UT2798A~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0337998	01/22/2009	CA	57.0	57		F	12/01/2008	Nerve in arm feel affected. Cannot lift arm without pain. Pain goes up to neck.  I waited to send this in to see if pain subsided. It did not. I cannot lift my arm and it (the pain) goes up my neck. My husband got the flu vaccine on the same day and has the same problem. Please advise.									N	10/06/2008	10/07/2008	1		OTH	PVT		None	Thyroid, allergies to grass, high blood pressure			1						1	Mobility decreased; Neck pain; Nerve injury; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338006	01/22/2009	OH	0.3	0	.3	M	01/19/2009	Vomiting, fussiness X 24 hrs, vomiting, resolved after 24 hours.				Y					Y	01/14/2009	01/14/2009	0		PVT	PVT		None				1						1	Irritability; Vomiting; Crying; Inappropriate schedule of drug administration; Vomiting; Wrong drug administered	FLU3~SANOFI PASTEUR~UT2782EA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~UT2782E~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0338009	01/22/2009	DC	55.0	55		F	01/16/2009	Patient complains of pain in left deltoid of site of influenza injection									Y	10/29/2008	11/04/2008	6	None	OTH	OTH	ZOLOFT; FLEXERIL; CONESTA; REFLEN	None	None			1						1	Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA172AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338014	01/22/2009	PA	1.9	1	.9	F	01/13/2009	Non stated.									Y	01/09/2009			None	PVT	PVT	None	None	None			1						1	No adverse event	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B065AA~1~UN~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~V2771AA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0987X~1~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C68305~1~UN~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0338015	01/22/2009	PA	0.7	0	.7	F	01/13/2009	None stated.										01/12/2009				PVT	PVT	None	None	None			1						1	No adverse event	FLU3~SANOFI PASTEUR~V2771AA~UNK~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0338016	01/22/2009	CA	62.0	62		F	01/22/2009	Pt called 10/31/08 said had blurring vision, earache, itching, & hives.  in our conversation pt stated had. hives, & itching previous to shot.  I attribute reaction to her previous allergy- not sure all symptom resolved by one week									Y	10/30/2008	10/31/2008	1		OTH	PVT		None noted	None known			1						1	Ear pain; Pruritus; Urticaria; Vision blurred	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89986~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0338017	01/22/2009	OR	70.0	70		F	01/22/2009	11/27/2006 Patient noticed pain in her left arm/ shoulder that has not resolved since injection.  on 1/21/09 she saw Dr who has noticed inflammation which is now being treated.									N	11/26/2008	11/27/2008	1		OTH	PVT						1						1	Inflammation; Musculoskeletal pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~878873P~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0335780	01/23/2009	CA	22.0	22		F	01/23/2009	NUMBNESS, WEAKNESS AND TINGLING TO LEGS, FEET, HANDS, ARMS, AND FACE. TREATMENT OF IVIG FOR FIVE DAYS IN HOSPITAL.			Y	Y	Y				Y	11/24/2008	12/05/2008	11	EMG, LUMBAR PUNCTURE, MRI (HEAD), CT (HEAD, THORACIC & LUMBAR SPINE).	UNK	UNK	NONE	NONE	NONE			1						2	Asthenia; Blood product transfusion; Computerised tomogram; Electromyogram; Hypoaesthesia; Lumbar puncture; Nuclear magnetic resonance imaging; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88634~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Life Threatening,Hospitalisation	Influenza
0338066	01/23/2009	ID	29.0	29		M	10/29/2008	Client woke up following morning with right ankle swollen so much he could hardly walk. Used heat, TYLENOL, MOTRIN with relief. No recent injury to ankle. States he does not have money to be seen by MD- vaccine required by employees.									U	10/27/2008	10/28/2008	1	None	PUB	PVT	PDD, Sanofi Pasteur, C2908AA, ID, LMF, 0	None	None		ID08042	1						1	Gait disturbance; Joint swelling	FLU3~SANOFI PASTEUR~U2804AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0240X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PPV~MERCK & CO. INC.~0804U~1~IM~LA~PNEUMO (PNEUMOVAX)~1|YF~SANOFI PASTEUR~UF306AA~1~SC~LA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0338104	01/23/2009	PR	39.0	39		F	01/23/2009	Numbness of hand and legs, cough, dizziness, nausea, malaise, muscular pain, gastrointestinal disturbance, face an throat rash.				Y					Y	12/10/2008	12/10/2008	0		PVT	UNK		none	none		PR-09-01	1						1	Cough; Dizziness; Gastrointestinal disorder; Hypoaesthesia; Malaise; Myalgia; Nausea; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~Aflua 373 CA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0338110	01/23/2009	PA	1.0	1	.0	M	01/23/2009	On 1/21/09 at the time of immunization, baby was seen and diagnosed with URI/(L)otitis media. Afebrile. During night of 1/22 developed fever of 102. On 1/23/08 about 7:30am had grand mal seizure. taken by ambulance to ACMH ER. temp 103.9 in ER. treated with antipyretics. dishcarged. Dx: acute febrile seizure/(L) otitis media. f/u PCP 2-3 days.				Y					Y	01/21/2009	01/23/2009	2	RIFA-neg. pulse ox 98%	PVT	PUB	none	URI/left otitis media	preemie			1						1	Condition aggravated; Febrile convulsion; Grand mal convulsion; Laboratory test normal; Otitis media; Oxygen saturation normal; Pyrexia	FLU3~SANOFI PASTEUR~UT27881A~2~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB258AA~1~IM~LL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~D01075~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0338124	01/23/2009	MA	5.0	5		M	12/05/2008	S1. erythematous left upper arm, slightly warm and tender. 2 days s/p DTap, flu IM injection Left deltoid and Polio SC.									Y	12/03/2008	12/04/2008	1		PVT	UNK		None	None			1						1	Erythema; Skin warm; Tenderness	DTAP~SANOFI PASTEUR~U2471AA~5~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2760AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0474~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0915X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0513X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0338125	01/23/2009	NC	6.0	6		M	01/23/2009	24 hours after influenza and HAVRIX were given in the left thigh, patient developed a warm, red, firm, tender area surrounding this site. It was measured at 7x3 inches max. No fever. Was treated with SEPTRA x 10 days and symptoms resolved in 9-10 days. No fevers.				Y					Y	01/08/2009	01/09/2009	1		PVT	PUB						1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U2848AA~5~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB257AA~2~IM~LL~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0338128	01/23/2009	GA	66.0	66		M	01/23/2009	Patient stopped by the clinic and stated since this flu shot on 11/24/08- He has had left sided neck pain and left arm soreness. He denied any chest pain, shortness of breath no complain of headache or dizziness.									U	11/24/2008			None	OTH	OTH		None				1						1	Neck pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2847AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0338136	01/23/2009	GA	54.0	54		F	01/07/2009	Client reports shortly after the shot, it is hard to pinpoint when it started a knot came up on (L) arm where the injection went in and had some swelling. It gradually kept getting worse. I can't lift my (L) arm up and I can't put it behind my back (to fasten my bra). Reports soreness after flu shot. States pain shoots down her (L) arm. States went to her doctor and he recommended sports medicine. Client states.				Y					N	10/02/2008			None	PUB	OTH	None (except vitamins)	None	Diagnosed with Lupus about 10 years ago			1						1	Injected limb mobility decreased; Injection site induration; Injection site swelling; Pain	FLU3~SANOFI PASTEUR~U2807AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0338116	01/24/2009	IN	54.0	54		F	01/24/2009	Patient stated pain began 4 hours after the immunization was administered on October 6, 2008, and has never been the same since.  She went to her primary doctor who gave her an anti-inflammatory.  Patient stated that did not help.  Her family doctor referred her to an orthopedic doctor who stated the patient has a frozen shoulder.  Patient has been given a cortisone shot by the orthopedic doctor.				Y					U	10/06/2008	10/06/2008	0	Patient states no tests or labs done.	UNK	PVT	Metoprolol er 50 mg                Hydrochlorothiazide 12.5mg	None	High blood pressure			1						1	Pain; Periarthritis	FLU3~CSL LIMITED~02349111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0338215	01/26/2009	PA	2.0	1	1	U		None Stated									U	01/08/2009				PVT	PVT						1						1	No adverse event	FLU3~SANOFI PASTEUR~U2771AA~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0338218	01/26/2009	UT				F	01/22/2009	Intermittent soreness let deltoid subsequent to vaccine.									N					PUB	PVT	AVANDAMET					1						1	Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89971~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0338220	01/26/2009	IA	1.0	1	.0	F	12/01/2008	11-12 day after injection developed red hard area no painful quarter size.  Resolved without  sequelae.				Y					U	11/19/2008	11/30/2008	11		PVT	PVT		None	None			1						1	Erythema; Induration	FLU3~SANOFI PASTEUR~U2739AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0987X~UNK~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C69205A~UNK~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0630X~UNK~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0338229	01/26/2009	LA	54.0	54		U	01/23/2009	Information has been received from a registered nurse and physician concerning a 54 year old patient who on 14-JAN-2009 was vaccinated with a intramuscular dose of PNEUMOVAX 23 and concomitantly at the same time with influenza virus vaccine (unspecified) in the left arm. On 16-JAN-2009 in the morning, the patient was at the physician's office and felt sick,had a fever of 103F and had low blood pressure. The injection site was red and swollen with about 7-8 cm of area affected. On 16-JAN-2009, the patient was hospitalized for allergic reaction and cellulitis. The patient was given BENADRYL, an unspecified steroid and ROCEPHIN IV. The registered nurse stated that the vaccine was not given in their office and so she does not have the lot number. She reported that the patient was taking trazodone, atenolol, NASONEX and ADVIL. Additional information has been requested.				Y	Y	0			U	01/14/2009	01/16/2009	2	Unknown	OTH	OTH	Atenolol; ADVIL; NASONEX; TRAZODONE hydrochloride		Unknown		WAES0901USA02460	1						1	Cellulitis; Hypersensitivity; Hypotension; Injection site erythema; Injection site swelling; Malaise; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0338246	01/26/2009	MT	1.0	1	.0	M	01/26/2009	Patient had his 1 yr well-baby check-up on Friday, January 16, 2009 and everything checked out perfectly for him.  He was given his vaccinations of 2nd dose of Flu, Chicken Pox, and two others that I'm not sure of.  He seemed a little fussy on Friday evening and off and on through the weekend so we did give him tylenol before bed and to help with the soreness at the injection sites.  On Tuesday, January 20, 2009 he was his happy ol' self.  We decided to go out to dinner that evening so I woke patient from his late afternoon nap just before 6 p.m. and he felt warm so we went to dinner thinking we'd have him eat before we gave him any tylenol or motrin and while we were at dinner, he ate and then didn't want to eat anymore, snuggled with me for awhile and then wanted daddy.  While sitting on daddy's lap he fell forward and was completely limp, this happend just before 7 p.m.  His eyes started rolling back in his head and his breathing slowed and he started to seize.  We called 911 and he continued to seize and began to vomit while in the ambulance to the hospital seizing for between 10 and 15 minutes.  Once in the ER he layed on the bed with big tears and little or no noise.  They took his temp and he was 102.2.  After he came out of the seizure we noticed he had no movement in his right arm or leg and that lasted for nearly 2 hours.  The ER did blood work on him, urine tests, a chest x-ray with all coming back normal.  He was admitted overnight and they performed an EEG on him Wednesday morning which also came back normal so his Dr. felt it was most likely caused from the chicken pox vaccine.  We were discharged Wednesday evening around 7:30 p.m. and asked to bring patient in Friday morning at 8 a.m. to be rechecked.  He was rechecked and everything was normal except he continued to run a temp.  His doctor told us that he would probably end up with a rash within the next day or two and then we'd know for sure.  His fever stopped on Saturday evening and a rash began to appear Sunday.  I contacted his doctor this morning to let him know how patient was doing and his nurse asked me to bring patient in to look at the rash.  When his doctor looked him over he said it looked more like rosiolla rash than chicken pox but that he wouldn't recommend and 2nd chicken pox vaccine for patient.  The only medication given to patient while in the hospital and at home to keep his temp down was tylenol and motrin.  His doctor did prescribe Diastat in case he seized again.  The prescription cost $313.00. 3/3/09-records received for DOS 1/20/09-admitted because of febrile seizure that was complicated, received vaccines 5 days prior and was crabby that evening, awoke with temperature of 102 and was fussy and then had a generalized tonic/clonic seizure, continued to arch and have right-sided weakness, stayed ictal for about half an hour then postictally and 3-4 hours before lost Todd's paralysis resolving .Assessment:complicated febrile seizure possibly exacerbated by immunization.				Y	Y	1			Y	01/16/2009	01/20/2009	4	EEG, Chest X-Ray, Blood panel, urine all normal 3/3/09-records received- Bicarb 17, labs WNL, chest x-ray normal, EEG pending.	UNK	UNK		None	None			1						1	Blood test normal; Body temperature increased; Chest X-ray normal; Convulsion; Electroencephalogram normal; Gaze palsy; Hypotonia; Injection site pain; Irritability; Lacrimation increased; Rash; Respiratory rate decreased; Roseola; Skin warm; Urine analysis normal; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~0919X~4~~~DTAP + HEPB + IPV (PEDIARIX)~1|FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PNC~PFIZER\WYETH~D26083~3~~~PNEUMO (PREVNAR)~1|VARCEL~UNKNOWN MANUFACTURER~1389X~4~UN~UN~VARICELLA (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0338252	01/26/2009	MO	69.0	69		M	01/26/2009	Hospitalized and diagnosed with Guillian-Barre Syndrome.  Weakness in upper extremities. 2/10/09 Received hospital medical records of 1/20-1/30/2009. FINAL DX: acute inflammatory polyradiculopathy; uncontrolled HTN; intractable nausea & vomiting; quadriparesis. Records reveal patient experienced UE & LE weakness, pain in shoulders, back & legs.  Tx w/IVIG x 3 w/o improvement.  Tx w/plasmapheresis w/modest improvement.  Transferred to higher level of care.  2/18/09 Reviewed hospital medical records of 1/30-2/5/2009. FINAL DX: acute motor axonal neuropathy; acute stroke. Records reveal patient experienced weakness of all extremities.  Had N/V/D approx 1 week after flu vaccine on 1/4/09.  Started w/weakness of extremities on 1/20.  Had been transferred to ICU from outlying hospital after IVIG x 3 & plasmapheresis x 4 w/only minimal improvement.  LP done.  Tx w/high dose steroids & plasmapheresis x 3 more.  Improved minimally but was able to ambulate w/mod assist & walker when transferred to inpatient rehab.					Y	16				12/24/2008	01/20/2009	27	LABS:  CSF:WBC 1, glucose 76, protein 52(H), c/s neg. CBC: lymphs 100%.  CT chest/abd/pelvis abnormal.  Stool & urine c/s neg.  MRI spine c/w DDD & osteophyte.  CXR WNL.  CT & MRI of brain (+) acute right parietal infarct.  EMG/NCS abnormal.  Carotid US w/mod plaque.  Echocardiogram WNL.	UNK	UNK	unknown	no known illness	unknown  PMH: HTN.  PUD, esophageal stricture, empyema, RAD, hyperlipidemia.  Family hx: both parents w/stroke.			1						1	Muscular weakness	FLU3~SANOFI PASTEUR~#U2849AC~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0338253	01/26/2009	TX	42.0	42		F	01/26/2009	Symptoms started two days after recieving the vaccine.  Experienced muscle pain, spasm, and weakness.  Have seen multiple doctors for treatment still no improvement.  Time course is about 3 months.  02/05/2009  MR received from PCP from 12/8/08 to 2/3/09. OV 12/8/08.  Pt preports increased body twitching, dizziness, difficulty walking, and muscle soreness of the arms and legs beginning on 10/19/08. Symptoms initially began in 2005. Nutritional IVs prescibed. Seen 1/6/09 with c/o facial rash since late october 2008. Papular rash noted of face/neck, tender to touch. Assess:  2 different rashes- 1-possible staph. 2-unknown possible derm rxn. Will cx if reoccurs.				Y				Y	N	10/17/2008	10/19/2008	2	Labs and Diagnostics:   NCS?EMG WNL. urine toxic metals WNL. Urine Mg++ high at 230 and 307.  allergy tests (-).	UNK	UNK			PMH: Pineal tumor. B12 Deficiency.  Hypothyroidism. Fatigue.  Constipation.  Hormone Deficiency. Allergic Rhinitis.  Eczema. Kidney stones			1						1	Muscle spasms; Muscular weakness; Myalgia	FLU3~SANOFI PASTEUR~u2761aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0338259	01/26/2009	CO	64.0	64		F	01/26/2009	64 yo F calling to report possible reaction to vaccines.  Traveling abroad, yellow fever area. On 1/16 received 5 vaccines.  Tdap, Flu, HepA, HepB and Yellow Fever.  On Thursday 1/22 she noticed a raised red area about the size of 50cent piece, itchy, left sub-Q area.  That resolved by 1/25 and she now has red/blue discolored area.  Not warm or hot to the touch. Denies any fever.  Sob, resp problem, dizziness.  On Sunday 1/25 she became nauseated with no appetite and achy.  No fever.  Today she has rash, small raised, over chest, stomach, legs and arms.  No itching, still denies fever, states she feels better today.  Is at work.  On further questioning she tells me she finished her Oral Typhoid vaccine on Thursday, 1/22. I advised her to call her MD, for evaluation and tx, I will fill out the Vaers form.  I further advised her if sx worsen, she needs to seek medical attention immediately.									U	01/16/2009	01/22/2009	6	Referred to her Personal Physician	UNK	UNK	HCTZ, Omeprazole	Mild uri	allergy to Sulfa, Hypertension			1						1	Anorexia; Dizziness; Erythema; Nausea; Pain; Pruritus; Rash; Skin discolouration	FLU3~SANOFI PASTEUR~U2849AC~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB555AA~UNK~IM~LA~HEP B (ENGERIX-B)~1|HEPA~MERCK & CO. INC.~0561X~UNK~IM~RA~HEP A (VAQTA)~1|TDAP~SANOFI PASTEUR~C3031AA~UNK~IM~LA~TDAP (ADACEL)~1|TYP~BERNA BIOTECH, LTD.~~UNK~PO~MO~TYPHOID LIVE ORAL TY21A (VIVOTIF)~1|YF~SANOFI PASTEUR~UF306AA~UNK~SC~LA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0338260	01/26/2009	MI	18.0	18		M	01/26/2009	3-4 hours after being vaccinated pt. began having SOB and then palpitations with heart racing.  Pt. taken to ER and admitted with tachycardia and BBB.  Pt. diagnosed with Wolf-Parkinson-White Syndrome and treated with cardioablation and B-blocker therapy.  2/2/09 PCP records received for 18 yr old PE dated 1/7/09. PE WNL. Flu shot given.  F/U note that pt began having SOB and heart racing that pm. Dx: Wolfe-Parkinson-White syndrome and had a cardioablation and placed on B-blocker.     2/20/09 MR received for DOS 1/8-13/2009 with Final DX:  Atrial fibrillation.  Anxiety state.  Reflux disease. Pt presented with 1 day hx of intermittent palpitations with SOB. Atrial fib with rapid ventricular response noted on EKG on arrival in ED, one episode of SVT. Admitted and started on Beta blockers. Episode of bradycardia in the 40's on 1/11/09 and chest pressure that pm. CP likely GERD. AV node ablation performed with resolution of arrhythmia. D/C on Beta blocker.				Y	Y	5			Y	01/07/2009	01/07/2009	0	EKG  in ER showed IRBBB and tachycardia.  Echocardiogram and CXR negative. Labs and Diagnostics: EP study abnormal-recuurant AV nodal echo beats.  CXR WNL. Myoglobin WNL. Serial cardiac enzymes WNL except final Troponin I 0.57.  Echo (+) for episodes of tachycardia.  Bubble study (-).  EKG (+) for RBBB.	UNK	UNK	None at the time of vaccination.	None	None. PMH:  EIA. T&A. allergic to beestings.			1						1	Bundle branch block; Cardiac ablation; Chest X-ray normal; Dyspnoea; Echocardiogram normal; Electrocardiogram abnormal; Palpitations; Tachycardia; Wolff-Parkinson-White syndrome	FLU3~SANOFI PASTEUR~U2745AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0338266	01/26/2009	AR	54.0	54		F	11/12/2007	Redness, swelling, warmth to site fever (100.2), chills, fatigue, achy.									Y	11/05/2007	11/06/2007	1		PVT	UNK		None				1						1	Chills; Fatigue; Injection site erythema; Injection site swelling; Injection site warmth; Pain; Pyrexia	FLU3~CSL LIMITED~03249111A~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0338267	01/26/2009	AR	53.0	53		F	11/03/2008	Approximately 24 hrs after injection, a hard reddish lump formed at injection site. it was painful to touch and very hot.									Y	10/28/2008	10/29/2008	1		MIL	OTH	Synthroid, Sera Vent, Singular, Metformin		Asthma			1						1	Injection site erythema; Injection site induration; Injection site mass; Injection site pain; Injection site warmth	FLU3~CSL LIMITED~03249111A~UNK~IM~~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0338269	01/26/2009	AR	58.0			F	12/04/2007	Swollen, warm, painful area 2x4 around injection area.									Y				None	PVT	UNK		None				1						1	Injection site pain; Injection site swelling; Injection site warmth	FLU3~CSL LIMITED~03249111A~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0338270	01/26/2009	AR	58.0	58		F	11/07/2007	Where shot given-is red and warm to the touch and a little sore.									Y	11/05/2007	11/06/2007	1	None	PUB	UNK		None	None			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U2461B~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0338271	01/26/2009	AR	56.0	56		U		Moderate headache with fatigue approximately 16 hours after flu shot. Duration was approx. 24 hrs. I rarely have a headache.									Y	10/28/2008	10/29/2008	1	None	PVT	UNK		None	None			1						1	Fatigue; Headache	FLU3~CSL LIMITED~03249111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0338274	01/26/2009	AR	58.0	58		F	10/30/2008	2 red, round, fever, swollen area, tender to touch right upper arm 24 hrs after shot given. Noted given posterior mid upper arm not deltoid.									U	10/28/2008			None	PUB	PVT		None	None			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~CSL LIMITED~03249111A~UNK~UN~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0338280	01/26/2009	TX	1.2	1	.2	M	01/26/2009	Mom returned to clinic 2d after vaccination & voiced pt had been to ER for febrile seizure post vaccination.				Y					Y	01/26/2009				PUB	PUB	TB skin test; Aventis; C2679AC; L Fore Arm, 1 Dose.		Jaundice of newborn/Anemia S/P I & D at age 8m			1						1	Febrile convulsion	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B065AA~5~UN~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2786GA~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB247AA~2~UN~RL~HEP A (HAVRIX)~1|HIBV~SANOFI PASTEUR~UF512AA~5~UN~LL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0745U~2~UN~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C25655~5~UN~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1144X~2~UN~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0338281	01/26/2009	KS	1.5	1	.5	F	12/16/2008	Right lower back - few small red raised bumps. Left front chest 1 small / pinpoint raised red bump. Mom gave Benadryl P.O. after onset of symptoms.									Y	12/16/2008	12/16/2008	0		PUB	PVT	None		Seen by physician - possibility of egg allergy VS viral illness		KS200825	1						1	Rash maculo-papular	FLU3~SANOFI PASTEUR~U2760AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0338282	01/26/2009	KS	52.0	52		M	11/10/2008	Pt received ADACEL RA upper deltoid, PNEUMOVAX RA lower deltoid.  On 11/4/08 since vaccinations febrile, chilling. Has not felt well since.  Negative cough, negative vomiting or diarrhea.  RA lower redened size of tennis ball, red streak going inward around arm.									Y	11/04/2008	11/05/2008	1	None	PVT	PVT	Advil 800 TID; LISINOPRIL 10 mg QD; Simvastatin 40 mg QD; METFORMIN 500 mg QD; FEXOFENADINE 180 mg QD; FLONASE QD.	Recovering from left rotator cuff surg.	NKDA		KS200823	1						1	Chills; Erythema; Malaise; Oedema peripheral; Pyrexia; Skin striae	FLU3~SANOFI PASTEUR~U2755AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0867X~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2998BA~UNK~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0338295	01/26/2009	KS	57.0	57		F	10/31/2008	Got vaccination 10-27-2008. 10-29-08 arm started aching. 10-30-08, arm swollen clear down into hand and up thru shoulder into neck.									N	10/27/2008	10/30/2008	3	None	PUB	PVT	Lipitor 1/2 TAB	None	None		KS200821	1						1	Local swelling; Oedema peripheral; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA366BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0338296	01/26/2009	KS	58.0	58		F	10/24/2008	Headache, weakness, decreased concentration, writing illegible, chills, stiffness lower extremities, muscle aching, fever 101 (although this was taken after client took hot bath for chills), eyes aching, nausea.									Y	10/22/2008	10/22/2008	0	None; BP, 109/66; P, 56	PUB	PUB					KS200820	1						1	Asthenia; Chills; Disturbance in attention; Dysgraphia; Eye pain; Headache; Heart rate decreased; Musculoskeletal stiffness; Myalgia; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~U2810AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0338309	01/26/2009	TX	9.0	9		M	01/23/2009	FLUMIST and VARIVAX vaccine were administered. Pt c/o chest pain at home. Pt returned to office, BP was taken and was monitored. c/o rash on body and itchy hands.				Y					U	01/22/2009	01/22/2009	0		PVT	PVT		None	None			1						1	Chest pain; Pruritus; Rash generalised	FLUN3~MEDIMMUNE VACCINES, INC.~5005890~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~7535X~2~UN~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0338315	01/26/2009	NC	20.0	20		F	01/22/2009	Redness-itching-blistering at injection site at about 12 hours after injection-warm compress. BENADRYL PRN.									Y	01/08/2009	01/08/2009	0		PUB	UNK	Mantoux, Sanofi Pasteur, C2920AB, L forearm, no previous doses; MOTRIN, PRN; ORTHO-TRICYCLEN	HIV+	HIV+			1						1	Injection site erythema; Injection site pruritus; Injection site vesicles	FLU3~SANOFI PASTEUR~U2760AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1163X~1~UN~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C3029AA~1~UN~RA~TDAP (ADACEL)~1	USA		Influenza
0336069	01/27/2009	NM	1.9			F	01/21/2009	A serious spontaneous report of accidental exposure, encephalitis, possibly having absent seizures and runny nose has been received from a Registered Nurse (the patient's mother) concerning a 23-month-old female.  Medical history and concomitant medications were not reported.  On 12-Nov-2008, the patient's father received FLUMIST.  The patient did not receive FLUMIST.  On 24-Nov-2008, the patient developed a runny nose that was off and on and lasted until 01-Dec-2008.  On 04-Dec-2008, the patient began experiencing neurological difficulties.  She developed ticks described as blinking with facial movements, shoulder movements down to her fingers, and toes twitching.  She had sensitivity to light and bad fevers which were 101-102 degrees F with treatment with acetaminophen.  She had cognitive and speech loss for 4 to 5 days where she was not able to speak like she normally did, she could not say apple which she could easily say previously and she would say what's that? to things that she previously knew.  She was not eating, only wanted to nurse, was not sleeping and was irritable.  She was not lethargic.  The patient went to the pediatrician on 05-Dec-2008 and 10-Dec-2008.  She was prescribed amoxicillin and the patient's mother was told only to give it to her if she got worse.  The patient started getting better so she never received amoxicillin.  On 17-Dec-2008, the patient was seen by a neurologist.  The neurologist indicated it was possibly encephalitis but there was no way to know because the patient's symptoms were resolving.  A brain magnetic resonance imaging on 18-Dec-2008 was normal.  There was no spinal tap or electroencephalography done.  The patient recovered except for having occasional headaches at night.  In follow up, the patient's mother indicated she was also possibly having absent seizures during the day so she was scheduled for an overnight EEG in March 2009.  The patient's mother indicated that the neurologist reviewed the chronology of the events and indicated that it could have been from exposure to the father after receiving FLUMIST.  The sponsor considered the events of encephalitis and possibly having absent seizures to be serious (important medical events).  Additional information received on 21-Jan-2009 and incorporated in the narrative included final diagnosis and the patient's current status.  The mother indicated the neurologist felt the patient's experience was encephalitis.									Y		12/04/2008		MRI, 12/18/08, normal	MIL	OTH	Concomitant Drug(s) Not Reported				MEDI0007640	1						2	Accidental exposure; Aphasia; Cognitive disorder; Decreased appetite; Encephalitis; Excessive eye blinking; Headache; Insomnia; Irritability; Muscle twitching; Nervous system disorder; Nuclear magnetic resonance imaging normal; Photophobia; Pyrexia; Rhinorrhoea; Secondary transmission; Tic	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0336135	01/27/2009	LA	1.1	1	.1	M	01/23/2009	Initial report received on 13 January 2009 from another manufacturer, report number A0761372A.  The initial reporter to this manufacturer had been a health care professional.  Verbatim from the report:  This case was reported by a physician and described the occurrence of fat atrophy in a 13-month-old male subject who was vaccinated with INFANRIX and ACTHIB.  The subject's medical history included cleft lip, cleft lip repair and renal problems.  Concurrent vaccination included influenza virus vaccine (manufacturer unspecified) and PREVNAR given on 29 September 2008.  Concurrent medications included Enalapril.  On 29 September 2008 the subject received 4th dose of INFANRIX (right thigh) and unspecified dose of ACTHIB (right thigh).  On 29 September 2008, less than one day after vaccination with INFANRIX, at an unspecified time after vaccination with ACTHIB, the subject experienced fat atrophy, skin discoloration, skin indentation and pain.  A physician reported that he gave a 13-month-old subject his 4th dose of INFANRIX vaccine and the subject developed a small purple spot that enlarged and became pitted over the course of one month.  There may have even some pain associated with the area, but the physician was not certain.  The subject also received an ACTHIB vaccine in the same thigh and separate location that day.  The physician is not certain if the site was of the INFANRIX or of the ACTHIB.  At the time of the report, the area had not improved or worsened but currently appeared to be a discolored, indentured area where the subcutaneous fatty tissue had atrophied leaving muscle directly covered with thin parchment like skin.  At the time of reporting the events were unresolved.  The physician considered the events were possibly related to vaccination with INFANRIX and ACTHIB.				Y					N	09/29/2008	09/29/2008	0	Unknown	PVT	PVT	ENALAPRIL		It was unknown if the subject had any illness at the time of vaccination.  The subject had a past medical history of cleft lip, cleft lip repair and renal problems.		200900149	1						2	Lipoatrophy; Pain; Skin atrophy; Skin discolouration; Skin disorder	DTAP~GLAXOSMITHKLINE BIOLOGICALS~~4~UN~RL~DTAP (INFANRIX)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HIBV~SANOFI PASTEUR~~UNK~UN~RL~HIB (ACTHIB)~2|PNC~PFIZER\WYETH~~UNK~UN~UN~PNEUMO (PREVNAR)~2	USA	Emergency room visit	Influenza
0338374	01/27/2009	NY	65.0	65		M	01/23/2009	Initial report received on 15 January 2009 from a consumer. A 65-year-old patient, who had no concurrent illnesses, but who has allergy to tree pollen, plums, hazelnuts and Red Delicious apples, had received on 15 December 2008 a dose of FLUZONE SV 2008-2009 (lot number U2803AA). The route and site of administration was not provided. The patient had not received any other vaccinations within four weeks of 15 December 2008; and had not experienced any adverse events with prior vaccination including several flu vaccines. The patient was taking PRILOSEC at the time of vaccination on 15 December 2008; however the indication for this medication was not provided. Approximately one week after receiving the FLUZONE vaccine, the patient starting having eye and facial swelling with facial numbness and pain on the right side of his face. He also experienced headache. Per the patient, he subsequently developed a shadow in his peripheral vision which has continued to worsen. He stated he had lost 80% of vision of the right eye. The patient was evaluated by a health care professional and had numerous tests/procedures including a Magnetic Resonance Imaging (MRI) test and computed axial tomography (CAT) scan; however the results were not provided. the patient is to be evaluated by a neuro-ophthalmolosgist the week of 19 January 2009. It was not reported whether the patient had received any treatment at this time, or if any diagnostic laboratory data had been performed. At the time of this report, it was unknown whether the patient had recovered. Documents held by sender: None.  2/5/09 Received PCP, vaccine ophtho & neurooptho medical records of 12/15/08-1/27/2009.  Ophtho records reveal patient seen 1/2/09 for c/o floaters OD x 1 week which worsened over next 6 days with vision decrease OD.  Dx: vitreous detachment/floater OD & subsequent non-arteritic anterior ischemic optic neuropathy.   PCP records of 1/8/09-1/27/09 reveal patient in usual state of health except for vision decrease OD.  RTC 1/27 & dx w/anxiety disorder generalized.  Neuro-ophtho records of 1/22/09 FINAL DX: anterior ischemic optic neuropathy, right side; disk at risk, left eye; no evidence of corneal anesthesia either side; & history of low-normal BP.				Y					U	12/15/2008	12/22/2008	7	MRI, CAT scan and numerous testing procedures; however no results were provided.  LABS: MRI head/orbits done 1/9 & repeat 1/14 WNL..  CBC & chemistry WNL.	OTH	OTH	PRILOSEC		The patient had no concurrent illnesses at the time of vaccination on 15 December 2008. The patient has allergy to tree pollen, plums, hazelnuts, and Red Delicious apples.  The patient currently takes concomitant medication Prilosec; however indication for this medication was not provided. The patient had not received any other vaccinations within four weeks of 15 December 2008; and has not experienced any adverse events with prior vaccinations including several flu vaccinations.  PMH: hypercholesterolemia, seasonal allergies, OA, colon polyps, GERD, cold sores, adenocarcinoma of mouth resected 2005.		200900174	1						1	Computerised tomogram; Diagnostic procedure; Eye swelling; Facial pain; Headache; Hypoaesthesia facial; Nuclear magnetic resonance imaging; Swelling face; Visual acuity reduced; Visual field defect; Blindness unilateral; Computerised tomogram; Ear pain; Nasopharyngitis; Nuclear magnetic resonance imaging; Paraesthesia; Swelling face; Vision blurred	FLU3~SANOFI PASTEUR~U2803A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2803AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0338379	01/27/2009	AZ	14.0	14		F	01/26/2009	Information has been received from a physician concerning a 14 year old female who on 17-NOV-2008 was vaccinated with the second 0.5 ml dose of GARDASIL (lot #660553/0070X). Concomitant vaccine included FLUMIST intranasal (cold adapted Ann Arbor master strain). On 22-NOV-2008 the patient developed sepsis shock, high fever, acute renal failure and coma after getting the second dose of GARDASIL and was hospitalized. It was unknown how many days the patient stayed in hospital. Subsequently, the patient recovered on unspecified dates. It was also reported that the patient did not experience any AE after getting the first dose. No additional information was provided. Additional information has been requested.  3/9/09 Received PCP medical records of 11/17/08-12/19/08 as well as partial hospital records. FINAL DX: encephalitis, septic shock Records reveal patient had sore throat & dx w/URI on 11/17/08 when received HPV #2 & flumist vaccines.  RTC 12/19 for hospital recheck w/residual hemipalsy.  Hospital records of 11/22-12/3/2008: FINAL DX: toxic shock syndrome of unknown etiology, posibly menstrual associated vs post vaccination; acute disseminated encephalomyelitis. Records reveal patient had 2 siblings w/N/V/D 1 week prior to her experienced right frontal HA, chills, fever, bilious emesis, right monocular blurred vision, abdominal pain, diarrhea.  Developed increasing confusion, lethargy, photophobia, emesis & became unconscious w/agonal breathing within 24 hours.  Intubated by EMS for respiratory failure, temp 103.3, posturing, pinpoint unreactive pupils.  Neuro, Neurosurgery, Ophtho, Heme & Renal consults done.  Developed DIC likely related to urosepsis & multiorgan failure, acute renal failure, right hypertropia.  Admitted to ICU & tx w/multiple IV antibiotics, steroids & pressors for low BP. Extubated 11/24.  Remained febrile w/injected eyes, swollen red tongue, rsh & abdominal tenderness.  Improved & transferred to inpatient neurorehab center.  3/12/09 Received additional hospital medical records of 11/22-12/3/2008 admit. Neurorehab consult revealed encephalitis of unknown cause w/cognitive impairment, gait disorder & visual deficits.  Accepted to rehab.				Y	Y	12			Y	11/17/2008	11/22/2008	5	Unknown  LABS: CT brain c/w cerebral edema.  MRI brain abnormal & c/w ADEM.  MRA head & neck & MRI of spine WNL.  EEG abnormal.  Renal US, visual evoked potentials, CT abdomen/pelvis WNL.  CRP 1921, CK 1921, BNP 854, lactate 4.77, creatinine 5.8/BUN, PT 19.8/PTT 33, D-Dimer 14.2 INR 2.  UA w/50WBCs, (+) leukocyte esterase & neg nitrites.  CSF: WBC 8, RBC 2600, glucose 142, protein 52.9.  All c/s neg.	OTH	OTH			Unknown		WAES0901USA02427	1						1	Coma; No reaction on previous exposure to drug; Pyrexia; Renal failure acute; Septic shock	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0070X~2~UN~UN~HPV (GARDASIL)~1	USA	Hospitalisation	Influenza
0338427	01/27/2009	LA	47.0	57		F	01/27/2009	Left upper arm pain that remains severe in mid upper arm where the injection was given on left since 10/20/2008 flu shot. NSAIDs nto helpful. US neg for DVT. MRI neg.				Y					N	10/20/2008	10/20/2008	0		PVT	UNK	zoloft, metformin, diovan	no	1. Type II diabetes mellitus 2. Dyslipidemia 3. Osteoarthritis 4. Depression 5. Obesity			1						1	Injection site pain; Nuclear magnetic resonance imaging normal; Ultrasound scan normal	FLU3~SANOFI PASTEUR~U2739AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0338431	01/27/2009	FL	51.0	51		F	01/27/2009	PT CLAIMS TO HAVE FLU AFTER 3 DAYS OF RECEIVING VACCINE AND ABOUT AFTER 5 DAYS SHE DEVELOPED TINNITUS AND PATIENT THINKS THAT THIS MIGHT BE RELATED TO THE VACCINE									U	11/05/2008	11/10/2008	5		UNK	UNK						1						1	Influenza; Tinnitus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0334585	01/28/2009	CT	26.0	26		F	01/26/2009	26 y/o, 12 wk EGA SM inadvertently administered FLUMIST by tech @ Immunization clinic.  Pregnancy question on screening form not answered by patient or signed by tech.  Dr. notified call center 15 Jan 09 that SM had a spontaneous miscarriage on 12 JAN 09 @ 17 weeks gestation.  Vaginal spotting began the afternoon that the FLUMIST was administered (12/08/08) and continued through termination of pregnancy.  This is the member's third pregnancy.  She had an elective abortion at age 16 and a spontaneous miscarriage at age 19.					Y	3			Y	12/08/2008	12/08/2008	0	Seen ED on 12/23/08 while visiting family for Christmas @ Hospital for vaginal bleeding - US and blood work obtained: strong fetal HR, baby appears to be fine; D/C w/ orders for bed rest. On 01/08/09 SM reported increased uterine cramping and passing blood clots. Saw OB Provider who listened to fetal HR and said baby sounded fine (no blood work or US performed). Then, on 01/11/09 SM experienced stronger uterine cramping and increased vaginal bleeding. Went to ED @ at Hospital. Membranes ruptured spontaneously while in ED. Blood work drawn. US on 12JAN09 showed that there was no amniotic fluid and pregnancy was no longer viable. OB Provider ordered chromosomal studies of fetus.	MIL	MIL	Given metronidazole for infection (no information) by Provider on 07JAN09).	None	Allergy PCN - Itching and hives discovered			1						2	Abortion spontaneous; Blood test; Drug exposure during pregnancy; Dysmenorrhoea; Thrombosis; Ultrasound scan abnormal; Vaginal haemorrhage	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Hospitalisation	Influenza
0335003	01/28/2009	CA	3.0	3		F	01/16/2009	A serious post-marketed study report of dehydration, pneumonia and acute gastroenteritis has been received from a study investigator concerning a three-year old female subject, patient ID 43450393, participating in a post-marketing study. The subject's past medical history includes asthma beginning 21-Nov-2005 and previous hospitalization for asthma and pneumonia in May 2006. Concomitant medications include albuterol and fluticasone propionate since 2005. The subject received FLUMIST intranasal on 14-Dec-2008 for influenza immunization. On 05-Jan-2008 the subject presented with vomiting, lethargy, poor oral intake for three days and two loose non bloody stools the day before. The subject was seen in the pediatric clinic and diagnosed with viral gastroenteritis. A trial of clear fluid and PEDIALYTE was not successful and the vomiting persisted. The subject's mother was concerned as she seemed to go in and out of consciousness and slept a lot. The subject had a slight upper respiratory infection with symptoms of coughing. It was noted the subject had a recent history of a plane flight on 04-Jan-2008. On 05-Jan-2008 the subject was brought into the emergency department for evaluation and given 40 ml/kg fluid bolus, albuterol nebulizer, intravenous steroids and ipratropium inhalation. Lethargy persisted and the patient was hospitalized for dehydration and altered mental status with secondary diagnoses of asthma, viral gastroenteritis and pneumonia. By the second day of hospitalization the gastroenteritis and dehydration resolved and her mental status returned to normal. On 07-Jan-2008 the subject developed more respiratory symptoms consisting of cough and wheeze without fever. Asthma treatment was initiated and she responded well and was started on cefuroxime for possible bacterial pneumonia. The chest xray was normal although there was persistent left upper lobe rhonchi. The subjects RSV PCR was positive from 07-Jan-2008. The subject did not require supplemental oxygen during hospitalization. On the morning of 09-Jan-2008 the subject was stable and well appearing and her appetite was almost back to baseline along with her level of activity. The subject was discharged and was considered recovered from the events. The investigator assessed the events of dehydration, pneumonia and acute gastroenteritis as not related to FLUMIST and provided an alternative etiology of viral. The sponsor assessed the relationship of the events to FLUMIST as not related. Additional information was received on 16-Jan-2009 and incorporated into the narrative: medical history, clinical course.					Y	0			Y	12/14/2007	01/03/2008	20	C7-Jan-2008; Resp, PCR-A, R, RSV; Positive for RSV by RT-PCR; blood culture, 1/6/08, no growth at 5 days; CBC, 1/6/08, normal; stool culture 1/6/08, no salmonella, shigella or campylobacter, isolated	OTH	OTH	ALBUTEROL; FLOVENT	Asthma	May 2006, hospitalization for asthma and clinical pneumonia		MEDI0007271	1						2	Asthma; Blood culture negative; Consciousness fluctuating; Cough; Culture stool negative; Dehydration; Diarrhoea; Full blood count normal; Gastroenteritis; Gastroenteritis viral; Hypersomnia; Hypophagia; Lethargy; Mental status changes; Pneumonia; Respiratory syncytial virus test positive; Upper respiratory tract infection; Vomiting; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500500P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Hospitalisation	Influenza
0338374	01/28/2009	NY	65.0	65		M	01/28/2009	Pt recieved a flu shot 12/15/08. 7 days later he developed cold like symptoms which only lasted 3 days and developed into facial swelling and what he described as a smudge over his right eye. By 1/2/09 25% of his vision was gone. By 1/15/09 he has totally lost his vision in the right eye which he described as having a tan nylon stocking over the eye.  He can see through it but it is mottled with lighter and more dense areas that impede his vision. On 1/4, 1/5 and 1/8 he saw his eye doctor (these reports will be sent to you). On 1/8 he was also seen by PCP.  A CT of the orbits was done 1/9/09 and an MRI on 1/14/09 (both will be forwarded).  On 1/22/09 he was seen by Dr. (report will be forwarded) and on 1/27/09 he was back in our office with continued complaints of vision loss, needle like pain in ear, pins and needle feeling over body. To-date his symptoms remain the same.									N	12/15/2008	12/22/2008	7	Lab results to be sent.	UNK	UNK	None at time of vaccine.  Will forward medication history	Torn meniscus knee	NKDA, prior history of buccal adenocarcinoma without recurrence.			1						2	Computerised tomogram; Diagnostic procedure; Eye swelling; Facial pain; Headache; Hypoaesthesia facial; Nuclear magnetic resonance imaging; Swelling face; Visual acuity reduced; Visual field defect; Blindness unilateral; Computerised tomogram; Ear pain; Nasopharyngitis; Nuclear magnetic resonance imaging; Paraesthesia; Swelling face; Vision blurred	FLU3~SANOFI PASTEUR~U2803A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2803AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0338443	01/28/2009	PA	65.0			M	01/27/2009	Information has been received from a physician concerning a 65 year old male who on 05-NOV-2008 was vaccinated with PNEUMOVAX 23 (Lot #661577/1161X). On 05-NOV-2008 the patient experienced tenderness, swelling and pain at the injection site. The pain became severe and stemmed from the shoulder up through the neck. The patient sought unspecified medical attention. Subsequently, the patient recovered from the adverse events. Follow-up information received from the physician indicated that the patient with asthma, hypolipidaemia, gout, diabetes mellitus and allergies to erythromycin and niacin received a dose of PNEUMOVAX 23 (Lot #661577/1161X) IM into the left arm on 06-NOV-2008 (previously reported by the physician as 05-NOV-2008). Concomitant therapy included influenza virus vaccine (unspecified) IM into the right arm on 06-NOV-2008. The patient experienced pain at injection site on 16-NOV-2008, 10 days after the vaccination. The patient also had difficulty ROM (range of motion). On 14-JAN-2009, one magnetic resonance imaging (MRI) of the left shoulder was performed. The changes on MRI suggested degenerative changes. The patient had an orthopedic evaluation after the MRI. The reporter considered tenderness, swelling and pain at the injection site, pain severe and stemmed from the shoulder up through the neck, difficulty ROM to be other important medical events. Additional information has been requested.									Y	11/06/2008	11/16/2008	10	magnetic resonance, Left shoulder; suggested degenerative changes	PVT	OTH		Drug hypersensitivity; Diabetes mellitus; Asthma; Hypolipidaemia; Gout			WAES0811USA02650	1						1	Injection site pain; Injection site swelling; Joint range of motion decreased; Musculoskeletal pain; Neck pain; Nuclear magnetic resonance imaging abnormal	FLUX~UNKNOWN MANUFACTURER~8488B~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1161X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0338466	01/28/2009	NC	62.0	62		M	01/28/2009	Retiree who received flu and ZOSTAVAX vaccine on 11/6/08 began to notice lethargy, myalgias, arthralgias that gradually grew worse. Was seen in ER and admitted to civilian hospital with dx of rhabdomylosis 2/2/09-records received for DOS 11/28-12/10/08-DC DX:Rhabdomyolysis. Secondary to influenza vaccination. Elevated transaminases. Three days prior to admission C/O severe muscle aches, weakness and decreased urine output. Edema.			Y	Y	Y	12			Y	11/06/2008	11/09/2008	3	Glucose SERUM, 156 mg/dL; Urea Nitrogen SERUM, 13 mg/dL; Creatinine SERUM, 0.8, mg/dL; Sodium SERUM, 134 mmol/L; Potassium SERUM, 3.2 mmol/L; Chloride SERUM, 96 mmol/L; Calcium SERUM, 7.7 mg/dL; Carbon Dioxide SERUM, 30 mmol/L; Anion Gap SERUM, 11 mmol/L; Osmalality Calculated SERUM, 272; GFR SERUM, >90; Myoglobin SERUM 19347 ng/mL; Hepatic Function Panel Site/Specimen, 26 Nov 2008, 0531 Units Ref Rng; Albumin SERUM, 2.5 g/dL; Bilirubin Direct SERUM, 0.4 mg/dL; Bilirubin SERUM, 1.1 mg/dL; Alkaline Phosphatase SERUM, 130, U/L; Alanine Aminotransferase SERUM, 583 U/L: Aspartate Aminotransferase SERUM, 1972 U/L; Protein SERUM, 4.0 g/dL; Myoglobulin SERUM, 21560 ng/mL  2/2/09-records received-Elevated CK 20,000 and elevated liver functions tests, hypokalemia. Echocardiogram ejection fraction 55-60% with diastolic dysfunction.	MIL	MIL	VYTORIN; ATENOLOL;  FLECAINIDE;  ASA; MAXIDE; LISINOPRIL;  LASIX;  KCL;  Fish oil;  MVI;  NIASPAN;  3 different inhalers	None	Hypercholesteremia;  CHF;  HTN;  COPD;  Obesity;  DM;  h/o A Fib 2/2/09-records received-PMH:paroxysmal atrial arrhythmias and systemic hypertension syncope, dyslipidemia, GERD, morbid obesity,emphysema, congestive heart failure, pancreatitis, degenerative arthritis, mild valvular regurgitation and COPD. Smoker.			1						1	Alanine aminotransferase increased; Anion gap normal; Arthralgia; Aspartate aminotransferase increased; Blood albumin decreased; Blood alkaline phosphatase increased; Blood bilirubin increased; Blood calcium decreased; Blood chloride decreased; Blood creatinine normal; Blood glucose abnormal; Blood potassium decreased; Blood sodium decreased; Blood urea normal; Carbon dioxide normal; Lethargy; Myalgia; Myoglobin blood increased; Protein total decreased; Rhabdomyolysis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0338472	01/28/2009	WI	46.0	46		M	01/27/2009	Received FLUZONE 1/15/09.  1 week later noted pain in both forearms & later both legs.   1/22/09 Mainly myalgias.  Still being evaluaated.									U	01/15/2009	01/22/2009	7		PVT	UNK		None	None			1						1	Myalgia; Pain in extremity	FLU3~SANOFI PASTEUR~U2853ABPRI~2~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0338476	01/28/2009	CA	4.0	4		F	01/28/2009	Patient recieved vaccines on 1/16/09 on both upper outer thighs.  On 1/17/09, patient's father phoned doctor on call, stating right thigh was swollen.  That night, parents took patient to ER where she was diagnosed with cellulitis and given a prescription of Keflex.  The next day, on 1/18/09 the swelling and redness had spread but the patient remained afebrile.  She was admitted to the hospital that night of 1/18 and placed on IV ceftriaxone BID, IV clindamycin q 6hrs, and IV benedryl BID.  By 1/19/09, the cellulits had improved.  The site is described as an approximately 1 inch band of redness extending around the right thigh with an irregular border.  There is central clearing at the injection site.  The patient is without pain and fever.  On 1/20/09, the site is described to be without swelling.  There is minimal bluish discoloration of the upper outer thigh where previously it was dark and purple.  Erythema of the right inner thigh was completely resolved.  The patient was in good spirits and eating lunch on the day of discharge, 1/20/09.  Patient was sent home on septra BID for 7 days and claritin qd for 2 days. 2/11/09-records received for DOS 1/18-1/20/09- DC DX:Right leg cellulitis versus allergic reaction to immunizations. Presented with swelling of right upper thigh, erythema, pain and induration. Treated with IVAB.					Y	2			Y	01/16/2009	01/17/2009	1	2/11/09-records received-WBC 14.0.	UNK	UNK	None	None	None			1						1	Cellulitis; Injection site discolouration; Injection site erythema; Injection site swelling	DTAP~SANOFI PASTEUR~U2470CA~5~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2756AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1084X~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Hospitalisation	Influenza
0338481	01/28/2009	NC	24.0	24		M	01/28/2009	Chills, fevers of up to 103.2, body aches, malaise, cough,small pustules on skin				Y					Y	01/22/2009	01/24/2009	2		MIL	MIL		none	morphine	same,but no rash~Anthrax (no brand name)~1~20.00~In Patient		1						1	Chills; Cough; Malaise; Pain; Pyrexia; Rash pustular	ANTH~EMERGENT BIOSOLUTIONS~FAV141orFAV162~2~IM~LA~ANTHRAX (BIOTHRAX)~1|FLU3~CSL LIMITED~01649111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0338488	01/28/2009	AK	49.0	49		F	01/28/2009	THE FLU SHOT WAS GIVEN DIRECTLY IN TO MY LEFT SHOULDER, UP VERY HIGH, AND BEHIND. I NOW HAVE A TEAR ON MY SUPRASPINATUS AND INFRASPINATUS MUSCLES, AND A PERFORATION ON MY ROTATOR CUFF TENDON. I FELT EXTREME PAIN WITHIN AN HOUR OF RECEIVING THIS IMMUNIZATION. I AM NOW IN PHYSICAL THERAPY, AND I AM GOING TO HAVE SURGERY TO REPAIR IT. I AM SURPRISED AT THE NUMBER OF PEOPLE WITH SHOULDER INJURIES FROM IMMUNIZATIONS. BETTER TRAINING NEEDS TO BE AVAILABLE TO ALL HEALTH CARE PERSONNEL ADMINISTERING THESE IMMUNIZATIONS. THEY ARE CAUSING MORE HARM, THEN GOOD.				Y					N	10/21/2008	10/21/2008	0	MRI, XRAYS, AND PATIENT FILES.	MIL	MIL		NONE	NONE			1						1	Muscle injury; Nuclear magnetic resonance imaging; Pain; Rotator cuff syndrome; X-ray	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0338503	01/28/2009	NJ	5.0	5		M	01/26/2009	1-16-09 vaccine given. 1-22-09 at 6pm began vomiting. At 9:40pm c/o knees killing me. Mom carried to bed 1-23-09 and 1-24-09, child home playing table games and watching TV, not running around, more sedentary. 1-25-09, 6:30 am patient lying on floor in bedroom screaming  I can't walk. Taken to ER lab work drawn and MOTRIN given. Discharged at 11am walking and ok.				Y					Y	01/16/2009	01/22/2009	6	Some lab work drawn at hospital ER, showed increased WBC, states mother	PUB	PVT	None	None	None			1						1	Abasia; Arthralgia; Blood test abnormal; Mobility decreased; Screaming; Vomiting; White blood cell count increased	FLU3~SANOFI PASTEUR~U2832AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0338556	01/29/2009	VA	2.0			U	01/27/2009	Initial report received on 21 January 2009 from a health care professional. A 2-year-old child, who has past medical history of respiratory syncytial virus (RSV), had received on an unknown day in October 2008 a dose of FLUZONE SV 2008-2009 (lot number unknown, route and site of administration not provided). At the time of the vaccination, the patient was taking Synergis. Approximately three months post vaccination in January 2009; the patient was hospitalized and diagnosed per a flu test with influenza B. It was unknown what type of flu test was administered, or if a sub-strain had been identified. It was reported the patient had received two previous doses of flu vaccine in 2007. The recovery status of the patient was not provided. Documents held by sender: None					Y	0			U	10/01/2008	01/01/2009	92	Flu test positive for influenza B (date not provided)	UNK	UNK			It was not reported whether the patient had any concurrent illnesses at the time of the vaccination in October 2008. The patient has a history of respiratory syncytial virus (RSV) and was taking Synergis at the time of vaccination.		200900243	1						1	Influenza; Influenza serology positive	FLU3~SANOFI PASTEUR~~3~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0338570	01/29/2009	WY	73.0	73		F		Left arm Pneumonia Vaccine R arm Flu vaccine and 7 hours later, L arm pain so severe + decreased mobility, went to the ER. ER Dr. was uncaring + wouldn't listen to symptoms so discourage + left ER, Pt has had severe muscle, joint pain to knees, thigh that hasn't resolved/ patient is undergoing multiple X-rays, tests, MRI for diagnosis.				Y					U	11/14/2008	11/14/2008	0	Unknown	PVT	UNK	Voltaren, Hydrocodone, Niacin, Synthroid, Norvasc, Citalopram	3 WKS Post-op R knee Arthroscopy	High Bp, High Chol, Hypothyroid			1						1	Arthralgia; Injected limb mobility decreased; Laboratory test; Musculoskeletal pain; Myalgia; Nuclear magnetic resonance imaging; Pain in extremity; X-ray	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0870x~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0338594	01/29/2009	NY	1.25	1	.2	F	01/29/2009	Patient developed a facial palsy on right side that started on or around 12/23/2008.  Patient was evaluated for Lyme which was negative.  No other cause determined.				Y					Y	10/30/2008	12/23/2008	54	Lyme titers negative	UNK	UNK	Luride 0.25 mg po qhs	None	GERD, Croup, Hypertonia as infant resolved			1						1	Borrelia burgdorferi serology negative; Facial palsy	DTAP~GLAXOSMITHKLINE BIOLOGICALS~ac14b085ba~4~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~ut2787ca~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0266x~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1146x~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0338595	01/29/2009	NY	21.0	21		F	01/29/2009	PT. HAD FLUSHOT 12/15/08 AND MOTHER SPOKE WITH ON CALL PHYSICIAN 12/16/08 AND STATED SHORTLY AFTER FLUSHOT PATIENT UNABLE TO CLOSE RIGHT EYE, DROOPY MOUTH ON RIGHT, SLIGHT RIGHT EAR PAIN.  PT SEEN AT HOSPITAL THAT EVENING AND DIAGNOSED WITH BELLS PALSY. PATIENT PRESCRIBED PREDNISONE 60 MG 1 PO Q DAY AND VALTREX 1 GM 1 PO TID BY ER AND FOLLOWED UP ON 12/19/08.  ONLY OTHER TREATMENT ADDED WAS METHYLCELLULOSE OINTMENT TO KEEP EYE MOIST.				Y					Y	12/15/2008	12/15/2008	0	NONE	UNK	UNK	NONE	VIRAL UPPER RESPIRATORY INFECTION AND PHARYNGITIS	ALLERGIES: NUTS GIVES PATIENT HIVES			1						1	Ear pain; Facial palsy	FLU3~SANOFI PASTEUR~U2798DA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0338597	01/29/2009	NY	67.0	67		F	01/29/2009	SWELLING AT INJECTION SITE									Y	11/03/2008	11/03/2008	0		MIL	MIL						1						1	Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88129~UNK~ID~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~08134~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0338600	01/29/2009	ID	52.0	52		F	01/29/2009	To start with, I was never alergic to anything in my life until they adminestired that flu shot that they told me I had to have to keep on working, although I told them that my whole family was alergic to flu shots and I did not want to take this shot. I break out in uticaria several times a day to the point that it is itching and burning so bad that I can barely stand it. I went to a Doctor and he said the flu shot had nothing to do with the hives that it was in my genetic background. So I have never went to another Doctor again. The shot was given in the year 2000, I have not been able to work since. My skin breaks out so bad when I get a bug bite or any kind of metal close to my skin. For the first two years, if I even got close to an orange I would break out in hives, or apples or bananas, could not eat eggs for over four years,									N	03/13/2000	03/13/2000	0		PUB	UNK	None	None	None			1						1	Burning sensation; Hypersensitivity; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~unknown~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0338606	01/29/2009	IL	31.0	31		F	01/12/2009	Within 6 hours of receiving vaccine had fever greater than 102F, chills, sore throat, muscle aches, fatigue, and dee non-productive cough.  lasted 4 days then resolved									Y	12/09/2008	12/09/2008	0		MIL	UNK	none	none	none		MO200902	1						1	Chills; Cough; Fatigue; Myalgia; Oropharyngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U2766AA~UNK~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0338616	01/29/2009	VA	51.0	51		M	01/29/2009	Pt states that in 2004 she received the flu shot while on duty as an RN at the TriCare clinic.  Within 15 minutes she had itching at the site that then spread to her entire body.  Next she had hives on the arm where she received the injection that spread to her entire body.  Then she experienced wheezing and SOB.  The pt states that a physician in the clinic gave her 50mg of Benadryl po.  Her symptoms resolved entirely within a couple of hours.  She was given a prescription for Zyrtec.  The pt states that she took one dose.										11/22/2004	11/22/2004	0		UNK	UNK		None	None			1						1	Dyspnoea; Injection site pruritus; Pruritus generalised; Urticaria; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0338617	01/29/2009	RI	65.0	65		M	01/23/2009	4x5cm area of redness. Left shoulder at injection site. Warm to touch.				Y					U	01/21/2009			None	PVT	PVT	VIAGRA; ALBUTEROL; ADVIL; ?; SOLITANE; ?; ATENOLOL; NORVASC	Bronchitis	HTN; Gout; Psoriasis			1						1	Feeling hot; Injection site erythema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA389BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1117X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0338619	01/29/2009	CO	64.0	64		M	01/29/2009	Patient complaining of rash on right side chest wall, some pain in his back through his anterior chest + in that same band of derma tone. Aching, irritating and burning internally. No fevers, chills or known immuno compromise. He has grouped erythematous papulous + smaller vesicles on right lateral chest wall the T8 to TIC derma tone Valtrex 10mg tid x 7 days. Lyrica Prn pain.				Y					N	01/13/2009	01/17/2009	4		PVT	PVT	Baby ASA, Lipitor, Finasteride, Flomax, Flaxseed, CA, CQ10, Selenium, Glucosamine, HVI.	None	NKDA, Increased lipids, Embolic CVA, BPH, ED, Tubular Adenoma, Colonie polyps			1						1	Back pain; Blister; Burning sensation; Pain; Rash erythematous; Rash papular	FLU3~SANOFI PASTEUR~U2853AB~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~1556X~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0338622	01/29/2009	MA	12.0	12		M	01/29/2009	Developed lump in R. arm circumference size of 2 silver dollars. Very red and sore.									Y	01/26/2009	01/28/2009	2		PVT	PUB	Alb MDI; PRILOSEC	None	Asthma; GERD			1						1	Erythema; Mass; Pain	FLU3~SANOFI PASTEUR~U2766AA~5~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2842AA~UNK~UN~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B030AA~UNK~UN~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0338640	01/29/2009	CT	8.0	8		F	01/28/2009	Pt has received FLUMIST in previous years. Received FLUMIST 1/15/09. Seen in ER 1/17/09 for presumed viral illness. Admitted to PICU 1/19/09 with encephalomyelitis.   3/25/09 Received hospital medical records of 1/19-2/9/2009. FINAL DX: viral meningeal encephalitis Records reveal patient experienced pharyngitis before Christmas, tx w/oral antibiotics, improved then relapsed & tx w/second round of oral antibiotics.  Improved & given flu shot.  Developed sore throat, cough, fever, runny nose& URI s/s again.  Seen in ER 1/17 & dx w/viral syndrome.  D/C to home then developed dizziness, falls, HA, emesis, eye deviation to right, sudden onset of inability to walk or talk.  Episodes of unresponsiveness thought to be seizures.  Neuro & ID consults done.  Admitted PICU.  Tx w/IV antibiotics, antivirals, steroids, antiseizure meds w/limited improvement.  Feeding tube inserted.  Labs & clinical status improved slowly but remained nonverbal w/very limited movement & unable to walk unassisted w/unsteady gait.  Transferred to rehab. Follow-up: Pt still with residual speech problem, difficulty with ambulation secondary to lower ext. weakness.				Y	Y	20			N	01/15/2009	01/19/2009	4	Bact'l cultures (-). Viral panel (-). DFA (-). MRI c/w acute disseminated encephalomyelitis  LABS:WBC 7.9(N), lymphs 27.7(L).  Creatinine 0.42(L), anion gap 17(H).  CSF: RBC 130(H), WBC 520(H), lymphs 92(H), monos 5(L), glucose 51(N) & protein 81(H).  Blood, urine & CSF c/s neg.  MRI brain abnormal & c/w encephalitis.	PUB	PUB			None  PMH: hypocalcemia resolved; fever requiring hospitalization; developmental delays & in special ed class.  Had received flu shot prior years w/o reaction.  Family hx: congenital heart defect.			1						1	Acute disseminated encephalomyelitis; Antibody test negative; Bacterial culture negative; Nuclear magnetic resonance imaging abnormal; Viral test negative	FLUN3~MEDIMMUNE VACCINES, INC.~500577P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0328605	01/30/2009	MA	35.0	35		M	01/07/2009	This case was reported by a healthcare professional and described the occurrence of injection site pain in a 36-year-old male subject who was vaccinated with FLULAVAL. Concurrent medical conditions included peanut allergy. On 14 October 2008 at 10:00, the subject received a dose of FLULAVAL (0.5 ml, unknown, left arm). On 14 October 2008, within hours of vaccination with FLULAVAL, the subject experienced injection site pain. Later that night on 14 October 2008, the subject experienced swollen lymph node under left armpit, chills and sweating. At the time of reporting the chills and sweating resolved on 15 October 2008; the injection site pain and swollen lymph node under left arm pit were unresolved. Follow-up information received on 7 November 2008, via healthcare professional who reported the subject saw his physician who diagnosed him with lymphadenitis and did not recommend treatment. As of 30 October 2008, the injection pain has resolved but the lymph mode is still tender and swollen. The healthcare professional considered the events possibly related to vaccination with FLULAVAL.				Y					N	10/14/2008	10/14/2008	0	UNK	OTH	PUB		Bee allergy; Erythromycin allergy; unknown reaction, Peanut allergy	No concomitant medications. The subject had not previously received influenza vaccinations. No adverse events were reported following receipt of prior immunizations. The subject uses alcohol infrequently and does not use tobacco.		A0753594A	1						2	Chills; Hyperhidrosis; Injection site pain; Lymph node pain; Lymphadenitis; Lymphadenopathy	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~2	USA	Emergency room visit	Influenza
0338667	01/30/2009	PA	1.0	1	.0	M	01/28/2009	Sudden death at home morning of 1/28/09.  6/1/09 Autopsy report states COD as sudden unexpected infant death & manner of death as natural.  Report also states patient found dead in crib, tox screens & cultures all neg.	Y	01/28/2009							N	01/27/2009	01/28/2009	1	Autopsy is being performed	PVT	PVT	None	None	None			1						1	Autopsy	FLU3~SANOFI PASTEUR~U2810AA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB274AD~1~UN~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1369X~1~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~021052~4~UN~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1406X~1~UN~LL~VARICELLA (VARIVAX)~1	USA	Results in Death	Influenza
0338689	01/30/2009	AZ	61.0	61		M	10/22/2008	Received Flu shot 10/14/08 Fry's. That nigh had hallucinations + feet extremely sweaty - wringing wet- 2nd night same thing hallucinations not feeling well. 3 days ago had muscle twitching in a leg he had injected a couple weeks ago. Not fully recovered but is better. (Had a previous injury to hip area + that's where the pain+ twitching starts)									Y	10/14/2008	10/14/2008	0		PVT	PVT	None	None	None			1						1	Hallucination; Hyperhidrosis; Malaise; Muscle twitching	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA183AA~1~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338691	01/30/2009	NC	0.5	0	.5	F	01/29/2009	No known reaction.  KINRIX accidentally administered instead of HEP B.									Y	01/23/2009			None	PVT	PUB	None	None	NKA			1						1	Wrong drug administered	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B103BB~UNK~UN~RL~DTAP + IPV (KINRIX)~1|DTAPIPVHIB~SANOFI PASTEUR~C3231AA~UNK~UN~LL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~U2760AA~UNK~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~D21052~3~UN~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0338693	01/30/2009	KY	1.2	1	.2	F	01/30/2009	On 12-19-08 increased temp 105.8 and febrile seizure.				Y					Y	12/08/2008	12/19/2008	11		PVT	UNK		Cough; diaper rash	PCN allergy			1						1	Body temperature increased; Febrile convulsion	FLU3~SANOFI PASTEUR~UT2792FA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB262AA~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1255X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~D01075~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1317~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0338704	01/30/2009	MI	14.0	14		M	01/30/2009	HE HAD CONVULSIONS FOR A DURATION OF ABOUT 20 SECONDS; HE DOESN'T REMEMBER ANY OF THAT TIME; HE WAS EXTREMELY PALE; THIS WAS ABOUT 15 MINUTES AFTER THE SHOT WAS ADMINISTERED AND HE HAD LEFT THE DR OFFICE AND WAS IN THE TRUCK WITH HIS FATHER LEAVING WHEN THE CONVULSIONS STARTED AND HIS DAD TURNED AROUND AND DROVE HIM BACK TO THE OFFICE WHERE HE LAID DOWN FOR ABOUT 30 MINUTES UNTIL HIS COLOR RETURNED. THE OFFICE INDICATED THEY FEEL HE JUST FAINTED.  PATIENT'S DAD WITNESSED THE TIGHTENING UP OF THE ENIRE BODY AND THE FLAILING AROUND OF HIS HEAD AND ARMS.  BY THE TIME THE OFFICE WAS INVOLVED PATIENT HAD COME OUT OF THAT PORTION AND WAS JUST PALE AND WEAK.									Y	01/29/2009	01/29/2009	0	MONITORED BLOOD PRESSURE AND EKG	UNK	UNK	NONE	NONE - WELL CHECK PHYSICAL	ALLERGY TO SUPRAX; NO OTHER HEALTH ISSUES	NONE~ ()~~0.00~In Patient|NONE~ ()~~0.00~In Sibling|NONE~ ()~~0.00~In Sibling		1						1	Asthenia; Convulsion; Electrocardiogram; Musculoskeletal stiffness; Pallor	FLUN3~MEDIMMUNE VACCINES, INC.~UNKNOWN~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~UNKNOWN~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0338706	01/30/2009	MD		42		F	01/30/2009	Pt states that the Last flu vaccine caused difficulty breathing and tighness in his chest for 3 days. He said that he did not go to the doctors because these symptoms have appeared each year following a flu shot, and assumed that things are just that way, and has lived with it his whole life. I encouraged him to see his PCM for a professional assessment.										10/01/2008	10/01/2008	0	none	MIL	MIL	na	vaccine withheld today	none noted			1						1	Chest discomfort; Dyspnoea; Vaccine positive rechallenge	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0338707	01/30/2009	OH	35.0	37		M	12/29/2008	Within 4 hours, patient began coughing and sneezing.  Eyes and lungs began to hurt.  Patient advised to contact personal physician who prescribed Prednisone, Kenalog and Claritin D.  Patient felt better within one day.				Y					Y	12/15/2008	12/15/2008	0		PUB	PUB						1						1	Cough; Eye pain; Sneezing	FLU3~SANOFI PASTEUR~U2832AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0338713	01/30/2009	PA	52.0	52		M	01/30/2009	On 1/08/09 Pt. awoke with flu like symptoms, pain in arms and purpura-like rash on legs.  Received prescription for steroid pack (pt. could not be more specific) to be taken for 5 days.  Pt. felt better on 1/09/09 but on 1/10/10 had swelling of wrists and ankles.  Rash remained.  At some point (pt. could not be more specific) he received another prescription for 5 days of steroids.  At some point he saw his physician.  On 1/22/09 he had a blood test (pt. could not be specific as to the type of test) which he states was positive for rheumatoid arthritis.  He was referred to a rheumatologist.  He has not had this appointment as yet.  After seeing his doctor, pt. developed bronchitis and was prescribed a Z-Pack. He is recovering from this illness at present.  2/5/09 Received PCP medical records of 1/12/09. FINAL DX: Purpura Records reveal patient experienced pain in bilateral forearms, raised red itchy rash bilateral thighs, pain in legs & feet x 4 days.  Patient had contacted family member who is MD & was tx w/steroids & NSAIDS w/improvement.  but symptoms recurred when steroids complete accompanied w/swelling of wrists & ankles, bruising of wrists & persistent rash on both legs.  Exam revealed extensive non-blanching purple coalescent macules on legs & grey green bruising on volar aspects of wrists.  Tx w/continued steroids & labs were ordered.				Y					N	01/02/2009	01/08/2009	6	Blood test which showed indication of rheumatoid arthritis.  Pt. did not know name of test.  LABS: RA factor (+), ANA neg, C3 WNL, C4 12.6(L), dsDNA WNL.	UNK	UNK	Simvastatin 40 mgs. qd	None	Hypercholesterolemia  PMH: sinus & colon polyps, mitral valve disorder, hyperlipidemia, spinal fusion, allergic rhinitis, false (+) hep C.			1						1	Blood test abnormal; Bronchitis; Influenza like illness; Joint swelling; Purpura; Rheumatoid arthritis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA357CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0338715	01/30/2009	OK	67.0	67		F	01/30/2009	Patient experienced soreness at the site where the Pneumovax was given (left deltoid).  Client reports chills, fatigue, and fever of 103 degrees for about 6 hours immediately after immunization was given.  Soreness remains at the site (left arm) over 3 months later.  Client describes it as a dull sensation.  Client reports soreness increases when affected arm is used (gardening, chores, etc).  The soreness subsides but never has been completely alleviated since the vaccine was given									N	10/20/2008	10/20/2008	0	None	UNK	UNK	Diovan 320 mg 1 PO daily; Zetia 10 mg 1 PO daily, Simvastatin 20 mg PO daily, Metformin 500 mg PO 2 tablets 2 x daily, glyburide 5 mg 1/2 tablet in morning and 1 tablet in evening, ASA 81 mg 1 PO daily, Multivitamin 1 PO daily, Fish oil 100	None	Allergy to Codeine (reaction: rash), Hypertension, Type II DM, Hypercholesterolemia.			1						1	Chills; Fatigue; Injection site pain; Pyrexia	FLU3~SANOFI PASTEUR~U2772AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0886F~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0338716	01/30/2009	NY	11.0	11		M	01/30/2009	Father reports fever of 100-103 for 3 days fllowing immmunization. afebrile today in clinic				Y					Y	01/26/2009	01/27/2009	1	None	UNK	UNK		URI	Asthma			1						1	Pyrexia	FLU3~SANOFI PASTEUR~U2898EA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB330A~2~IM~RA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2687AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0338718	01/30/2009	NY	24.0	24		M	01/30/2009	right arm swelling, pain & redness 2 days after administration of vaccines									U	01/28/2009	01/29/2009	1		UNK	PVT	ambien	no	no			1						1	Erythema; Oedema peripheral; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA389BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB155AA~1~IM~RA~HEP A + HEP B (TWINRIX)~1|PPV~MERCK & CO. INC.~1076x~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0338738	01/30/2009	NM	0.6	0	.6	F	01/30/2009	This case was reported by a healthcare professional and described the occurrence of diarrhea in a 6-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACTHIB, (non-gsk) PREVNAR, ROTATEQ (non-gsk) and seasonal  (non-gsk) FLUZONE. On 6 January 2009 the subject received 3rd dose of PEDIARIX (.5 ml, unknown, right thigh), 2nd dose of ACTHIB, 3rd dose of PREVENAR, 3rd dose of ROTATEQ, and 1st dose of FLUZONE. On 6 January 2009, within hours of vaccination with PEDIARIX and after an unspecified amount of time within the same day of vaccination with PREVNAR, ACTHIB, FLUZONE and ROTATEQ, the subject experienced diarrhea, infant feeding problems, fever, vomiting and inability to eat. The nurse reported that a subject developed a severe reaction after her third vaccination with PEDIARIX. The subject developed a fever of 101.6, diarrhea, vomiting, eating only once every 24 hours, and unable to eat. These symptoms developed a few hours after the vaccination and are worsening. The subject has been seen by emergency rooms, urgent care centers and doctor's office without any improvement. The nurse stated that the subject also received several other vaccines that same day and she is not sure which was related or if the vaccines are involved in the adverse events. The healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were worse.			Y	Y				Y	U	01/06/2009	01/06/2009	0	Body temperature, 101.6	PVT	OTH		Unknown	No relevant medical history was reported. The subject had no adverse events following previous vaccinations.		A0765333A	1						1	Body temperature increased; Diarrhoea; Eating disorder; Feeding disorder of infancy or early childhood; Pyrexia; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B17AA~3~UN~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT276GA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF442AA~UNK~UN~UN~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C7459~UNK~UN~UN~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0310X~UNK~UN~UN~ROTAVIRUS (ROTATEQ)~1	USA	Life Threatening,Disabling	Influenza
0338944	01/30/2009	MA				F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of incorrect route of drug administration in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent vaccination included Salmonella typhi Vi capsular polysaccharide vaccine given on an unspecified date. There were no concurrent medications. On 2 November 2008, between 09:00 and 16:00, the subject received a dose of FLULAVAL 0.5 ml, subcutaneously. This was the incorrect route of drug administration. FLULAVAL should have been administered intramuscularly. Within 12 to 24 following injection of FLULAVAL, the subject experienced injection site pain, redness and swelling. At the time of reporting, the events were improved. In the reporter's opinion, the events were probably related to treatment with FLULAVAL. The reported stated that approximately 200 adults were vaccinated with FLULAVAL via deep subcutaneous injection during a flu clinic. Out of these 200 plus subjects, four females reported local reactions of pain, redness and swelling within 12 to 24 hours of vaccination. One of these subjects was seen by the on-site physician who diagnosed it as a secondary infection and treated with antibiotics and TYLENOL. It was reported that the adverse events were improving, but unknown if they resolved. Linked cases include: A0759176A, A0759183A, A0759189A, and A759190A.									N	11/02/2008	11/02/2008	0	UNK	MIL	MIL	No concurrent medication	Unknown	The subject had no relevant medical history. The subject has previously received flu shots with no known reactions. There was no history of adverse events following previous vaccinations. Linked cases include: A0759176A, A0759183A, A0759189A, and A759190A.		A0759188A	1						1	Incorrect route of drug administration; Injection site erythema; Injection site pain; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA192AA~UNK~SC~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338945	01/30/2009	MA				F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of incorrect route of drug administration in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent vaccination included Salmonella Vi capsular polysaccharide vaccine given on an unspecified date. There were no concurrent medications. On 2 November 2008, between 09:00 and 16:00, the subject received a dose of FLULAVAL 0.5 ml, subcutaneously. This was the incorrect route of drug administration. FLULAVAL should have been administered intramuscularly. Within 12 to 24 hours following injection of FLULAVAL, the subject experienced injection site pain, redness and swelling. At the time of reporting, the events were improved. In the reporter's opinion, the events were probably related to treatment with FLULAVAL. The reported stated that approximately 200 adults were vaccinated with FLULAVAL via deep subcutaneous injection during a flu clinic. Out of these 200 plus subjects, four females reported local reactions of pain, redness and swelling within 12 to 24 hours of vaccination. One of these subjects was seen by the on-site physician who diagnosed it as a secondary infection and treated it with antibiotics and TYLENOL. It was reported that the adverse events were improving, but unknown if they resolved. Linked cases include: A0759176A, A0759188A, A0759189A, A07159190A									N	11/02/2008	11/02/2008	0	UNK	MIL	MIL	No concurrent medication	Unknown	The subject had no relevant medical history. The subject has previously received flu shots with no known reactions. There was no history of adverse events following previous vaccinations. Linked cases include: A0759176A, A0759188A, A0759189A, A07159190A		A0759183A	1						1	Incorrect route of drug administration; Injection site erythema; Injection site pain; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA192AA~UNK~SC~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338946	01/30/2009	MN	1.3	1	.3	M	01/07/2009	This case was reported by a healthcare professional and described the occurrence of fever in a 15-month-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Previous and/or concurrent vaccination included PEDVAXHIB; Merck; unknown given on 4 November 2008; HAVRIX; GlaxoSmithKline; unknown; unknown given on 4 November 2008. On 4 November 2008 the subject received a dose of FLULAVAL (.5 unknown, unknown, right thigh) and the subject experienced drug use for unapproved indication. At an unspecified time after vaccination with FLULAVAL, the subject experienced fever. The healthcare professional reported that a 15-month-old subject was administered FLULAVAL vaccine on 04 November 2008 in addition to HAVRIX and PEDVAXHIB. She reported that the mother told her the subject had some fever up to 100.3  off and on that was treated with over the count TYLENOL. The subject was treated with TYLENOL. At the time of reporting the outcome of the events were unspecified. Follow-up information was received on 17 December 2008, via healthcare professional who reported the events resolved on an unknown date.				Y					Y	11/04/2008	11/04/2008	0	Body temperature, 100.3	OTH	OTH		Unknown	No concomitant medications. The subject had no relevant medical history.		A0759008A	1						1	Body temperature increased; Inappropriate schedule of drug administration; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB234BA~UNK~UN~UN~HEP A (HAVRIX)~1|HIBV~MERCK & CO. INC.~1013F~UNK~UN~RL~HIB (PEDVAXHIB)~1	USA	Emergency room visit	Influenza
0338947	01/30/2009	FL	65.0	65		M	01/07/2009	This case was reported by a physician and described the occurrence of pain radiating down arm in a 65-year-old male subject who vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included anxiety and gastroesophageal reflux disease. Concurrent  medications included PRILOSEC, WELLBUTRIN, KLONOPIN, SEROQUEL, CYANOCOBALAMIN and LEXAPRO. On 22 October 2008 the subject received a dose of FLULAVAL at 0.5 ml in  the left arm via a 25 gauge 5/8 inch needle. Within 24 hours of FLULAVAL administration, the subject developed excruciating pain that radiated down the arm. He returned to the physician's office two days later. Two weeks later, an MRI as conducted. The MRI showed fluid collection at the injection site, but nothing else. The subject had no inflammation and good range of motion. He was treated with MEDROL DOSE PAK, antiinflammatories and PERCOCET. At the time of reporting the events were unresolved. The physician considered the events were probably related to vaccination with FLULAVAL. Follow-up information received via the subject on 06 November 2008 indicated that he suffered from pain in his left arm for 22 days before feeling improvement. The subject reported throbbing, achyness, inability to sleep on his sides (has to sleep on back) and inability to lift heavy things. He also reported that he was unable to close the car door with his left hand and had to use his right. He additionally reported that when he holds his left arm (which had full range of motion) up in the air, it feels better. The subject claimed that her initially reported his condition to his physician on 24 October 2008. He was prescribed DARVOCET, which he reported did not work. He then received PERCOCET which helped. He was also prescribed MEDROL DOSE PAK he took for two days and stopped because he developed stomach pains and diarrhea. He was given a mouthwash to assist with the stomach problems. A repeat MRI was negative. The subject claimed that he was bedridden for 2 weeks, which resolved and he had been unable to do anything, but that has now improved.				Y					N	10/22/2008	10/22/2008	0	An MRI was conducted approximately two weeks following the onset of the event (date not provided) which showed fluid collection at the injection site, but nothing else. A second MRI performed on an unknown date was negative.	PVT	PUB	OMEPRAZOLE, BUPROPION HYDROCHLORIDE, CLONAZEPAM, QUETIPINE FUMARATE, CYANOCOBALAMIN, LEXAPRO	ANXIETY, GASTROESOPHAGEAL REFLUX DISEASE	SHOULDER DISLOCATION, The subject has previously received flu shots without reactions. There is no history of adverse events following previous vaccinations. The subject reports that he dislocated his shoulder (unsure which arm) 20 years ago. This occurred twice.		A0757991A	1						1	Abdominal pain upper; Activities of daily living impaired; Bedridden; Diarrhoea; Hypokinesia; Injection site reaction; Nuclear magnetic resonance imaging abnormal; Pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA191AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0338948	01/30/2009	FL				F	01/07/2009	This case was reported by a consumer and described the occurrence of erythema in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included FEMARA, LIPITOR, LEVOXYL and Antihistamine. On 10 November 2008 at 10:00, the subject received a dose of FLULAVAL (.5 ml, unknown, right arm). On 10 November 2008, less that one day after vaccination with FLULAVAL, the subject experienced erythema, itching, swelling and black & blue marks on skin. The subject planned to follow-up with her physician on an unknown date. At the time of reporting the events were improved.				Y					N	11/10/2008	11/10/2008	0	UNK	PVT	OTH	LETROZOLE, ATORVASTATIN CALCIUM, THYROXINE SODIUM, ANTHIHISTAMINE	Unknown	BREAST CANCER, HIGH CHOLESTEROL, THYROID PROBLEMS; The subject had not previously received influenza vaccinations and no adverse events were reported following receipt of prior immunizations.		A0757768A	1						1	Erythema; Pruritus; Skin discolouration; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA168AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0338949	01/30/2009	NY				F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of bilateral conjunctivitis in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 10 November 2008, the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). The FLULAVAL expiration date was reported as 2008/2009. On 11 November 2008, 1 day after vaccination with FLULAVAL, the subject experienced bilateral conjunctivitis and swollen eyes. The healthcare professional reported that a subject received FLULAVAL and woke up the following morning with swollen eyes and bilateral conjunctivitis. She was evaluated by and ophthalmologist because they thought it might be caused by allergies; however the cause could not be determined. At the time of reporting the outcome of the events were unspecified.				Y					U	11/10/2008	11/11/2008	1	UNK	PVT	OTH		Unknown	No relevant medical history. The subject had previously received influenza vaccinations and no adverse events were reported. No adverse events were reported following receipt of prior immunizations. The healthcare professional reported that the subject stated her friend also experienced the same reaction after receiving a flu shot, but no details were provided. See case A0757757A.		A0757735A	1						1	Conjunctivitis; Eye swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0338950	01/30/2009	NC				F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of leg rash in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 30 October 2008 at 12:00 the subject received a dose of FLULAVAL, the subject experienced leg reach and itching. Rash on ankles was also reported. The subject was treated with CORTICOSTEROIDS and ANTIHISTAMINES. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. The reporter stated that 6 subjects in an employee flu clinic developed a rash on their legs and ankles approximately two days after receiving the FLULAVAL vaccine. The subjects describes the rash as appearing as a heat rash. Two of the subjects were females and were treated by a physician with CORTICOSTEROIDS and ANTIHISTAMINES. Some of the subjects were males, but exact details were not known. The healthcare professional reported additional cases see: A0757694A and A0757715A - A0757718A. Follow-up information was received on 09 December 2008, via healthcare who reported she was not sure if the event was related to the vaccine or not. The reporter stated she was told that two females and three males had a rash. As of this report, the healthcare professional had not received further information. She did state that two subjects saw their private physicians.				Y					Y	10/30/2008	11/01/2008	2	UNK	OTH	OTH		Unknown	The subject has previously received flu shots with no reported reactions. There is no history of adverse events following previous vaccinations.		A0757719A	1						1	Heat rash; Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA165AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0338951	01/30/2009	NC				F	01/07/2009	This case was reported by a healthcare professional describe the occurrence of leg rash in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 30 October 2008  12:00 the subject received a dose of FLULAVAL at 0.5 ml. On 1 November 2008, 48 hours after vaccination with FLULAVAL, the subject experienced leg rash and itching. Rash on ankles was also reported. The subject treated with corticosteroids and antihistamines. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. The reporter stated that 6 subjects in an employee flu clinic developed a rash on their legs and ankles approximately two days after receiving the FLULAVAL vaccine. The subjects describes the rash as appearing as a heat rash. Two of the subjects were females and were treated by a physician with corticosteroids and antihistamines. Some of the subjects were males, but exact details were not known. The healthcare professional reported additional cases see: A0757694A and A0757715A- A0757717A, A0757719A. Follow-up information was received on 09 December 2008, via healthcare professional who reported she was not sure if the event was related to the vaccine or not. The healthcare professional stated that 01 December 2008 the complaint was resolved. The reporter stated she was told that two females and three males had a rash. As of this report, healthcare professional had not received further information. She did stated that two subject saw their private physicians.				Y					Y	10/30/2008	11/01/2008	2	UNK	OTH	OTH		Unknown	The subject has previously received flu shots with no reported reactions. There is no history of adverse events following previous vaccinations.		A0757718A	1						1	Heat rash; Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA165AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0338952	01/30/2009	NC				M	01/07/2009	This case was reported by a healthcare professional and described the occurrence of leg rash in an adult male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 20 October 2008 at 12:00 the subject received a dose of FLULAVAL, the subject experienced leg rash and itching. Rash on ankles was also reported. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. The reporter stated that 6 subjects in an employee flu clinic developed a rash on their legs and ankles approximately two days after receiving the FLULAVAL vaccine. The subjects describes the rash as appearing as a heat rash. Two of the subjects were females and treated by a physician with corticosteroids and antihistamines. Some of the subjects were males, but exact details were not known. The healthcare professional reported additional cases see: A0757694A, A0757715A, A0757716A, A0757718A,  and A0757719A. Follow-up information was received on 09 December 2008, via healthcare professional who reported she was not sure if the event was related to the vaccine or not. The healthcare professional stated that 01 December 2008 the complaints were resolved. The reporter stated she was told that two females and three males had a rash. As of this report, the healthcare professional had not received further information. Se did state that two subjects saw their private physicians.				Y					Y	10/30/2008	11/01/2008	2	UNK	OTH	OTH		Unknown	The subject has previously received flu shots with no reported reactions. There is no history of adverse events following previous vaccinations.		A0757717A	1						1	Heat rash; Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA165AA~UNK~ID~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0338953	01/30/2009	NC				M	01/07/2009	This case was reported by a healthcare professional and described the occurrence of leg rash an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On October 2008 at 12:00 the subject received a dose of FLULAVAL at 0.5 ml. On November 2008, 48 hours after vaccination with FLULAVAL, the subject experienced leg rash and itching. Rash on ankles was also reported. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. The reporter stated that 6 subjects in an employee flu clinic developed a rash on their legs and ankles approximately two days after receiving the FLULAVAL vaccine. The subjects describes the rash as appearing as a heat rash. Two of of the subjects were females and were treated by a physician with corticosteroids and antihistamines. Some of the subjects were males, but exact details were not known. The healthcare professional reported additional cases see: A0757694A, A0757715A, A0757717A, A0757719A. Follow-up information was received on 09 December 2008, via healthcare professional who reported se was not sure if the event was related to the vaccine or not. The healthcare professional stated that 01 December 2008 the complaints were resolved. The reporter stated she was told that two females and three males had a rash. As of this report, the healthcare professional had not received further information. She did state that two subjects saw their private physicians.				Y					Y	10/30/2008	10/30/2008	0	UNK	OTH	OTH		Unknown	The subject has previously received flu shots with no reported reactions. There is no histor of adverse events following previous vaccinations.		A0757716A	1						1	Heat rash; Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA165AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0338954	01/30/2009	NC				M	01/07/2009	This case was reported by a healthcare professional and described the occurrence of leg rash an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On October 2008 at 12:00 the subject received a dose of FLULAVAL at 0.5 ml. On November 2008, 48 hours after vaccination with FLULAVAL, the subject experienced leg rash and itching. Rash on ankles was also reported. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. The reporter stated that 6 subjects in an employee flu clinic developed a rash on their legs and ankles approximately two days after receiving the FLULAVAL vaccine. The subjects describes the rash as appearing as a heat rash. Two of of the subjects were females and were treated by a physician with corticosteroids and antihistamines. Some of the subjects were males, but exact details were not known. The healthcare professional reported additional cases see: A0757694A, A0757716A, A0757719A. Follow-up information was received on 09 December 2008, via healthcare professional who reported se was not sure if the event was related to the vaccine or not. The healthcare professional stated that 01 December 2008 the complaints were resolved. The reporter stated she was told that two females and three males had a rash. As of this report, the healthcare professional had not received further information. She did state that two subjects saw their private physicians.				Y					Y	10/30/2008	11/01/2008	2	UNK	OTH	OTH		Unknown	The subject previously received flu shots with no reported reactions. There is no history of adverse events following previous vaccinations.		A0757715A	1						1	Heat rash; Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA165AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0338955	01/30/2009	NC				U	01/07/2009	This case was reported by a healthcare professional and described the occurrence of leg rash in an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 30 October 2008 at 12:00 the subject received a dose of FLULAVAL at 0.5 ml. On 1 November 2004, 48 hours after vaccination with FLULAVAL, the subject experienced leg rash and itching. Rash on ankles was also reported. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. The reporter stated that 6 subjects in an employee flu clinic developed a rash on their legs and ankles approximately two days after received the FLULAVAL vaccine. The subjects describe the rash as appearing as a heat rash. Two of the subjects were females and were treated by a physician with corticosteroids and antihistamines. Some of the subjects were males, but exact details were not known.				Y					N	10/30/2008	11/01/2008	2	UNK	OTH	OTH		Unknown	The subject has previously received flu shots with no reported reactions. There is no history of adverse events following previous vaccinations.		A0757694A	1						1	Heat rash; Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA165AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0338956	01/30/2009	FL	37.0	37		F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of shoulder bursitis in a 37-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included ADVIL. On 21 October 2008 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. At an unspecified time after vaccination with FLULAVAL, the subject experienced shoulder bursitis, inflammation of shoulder joint, shoulder pain and injection site tenderness. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. Warm soaks and continued use of ADVIL was recommended. Follow-up information was received on 11 December 2008, via healthcare professional, who reported the events were unresolved. The reporting healthcare professional considered the events related to vaccination with FLULAVAL.									N	10/21/2008			UNK	PVT	PVT	Ibuprofen	Unknown	The subject has no relevant history and has not previously received flu shots. There is also no history of adverse events with previous vaccinations.		A0757689A	1						1	Arthritis; Bursitis; Injection site pain; Musculoskeletal pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA179AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338957	01/30/2009	CA	35.0	35		F	01/07/2009	This case was reported by a physician and described the occurrence of generalized itchy rash in a 35-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 7 November 2008 at 14:00, the subject received unspecified dose of FLULAVAL (.5 ml, unknown). On 7 November 2008, at an unspecified time after vaccination with FLULAVAL, the subject experienced generalized itchy rash. The subject was treated with BENADRYL. The physician reported that a female subject received a FLULAVAL vaccine during her employer's flu clinic and developed generalized itching rash on her arms and trunk one hour after the injection. The subject may have taken some BENADRYL. The rash was resolving by the time the physician saw the subject in her office. No other symptoms were reported. At the time of reporting the event was improved. The physician considered the event was possibly related to vaccination with FLULAVAL.				Y					N	11/07/2008	11/07/2008	0	UNK	OTH	OTH		Unknown	The subject had previously received influenza vaccinations and no adverse events were reported. No adverse events were reported following receipt of prior immunizations.		A0757324A	1						1	Rash generalised; Rash pruritic	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0338958	01/30/2009	VA	30.0			F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of pain in shoulder joint in a 30-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 30 October 2008 at 12:00 the subject received a dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced extreme pain in the shoulder joint. The subject took ALEVE twice daily for the pain. The event was unresolved at the time of reporting.				Y					N	10/30/2008			UNK	OTH	OTH		Unknown			A0757298A	1						1	Arthralgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA179AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0338959	01/30/2009	MA	60.0			F	01/07/2009	This case was reported by a physician and described the occurrence of high fever in a 60-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL (unknown). Seven hours after vaccination with FLULAVAL, the subject experienced high fever. At the time of reporting the outcome of the event was unspecified.				Y					U				UNK	OTH	OTH		Unknown			A0757118A	1						1	Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0338961	01/30/2009	UT	57.0	57		F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of injection site pruritus in a 57-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 12 November 2008 at 10:15, the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). On 12 November 2008, immediately after vaccination with FLULAVAL, the subject experienced injection site pruritus and injection site redness. The healthcare professional reported that a subject received a FLULAVAL vaccination at an on job site flu clinic at 10:15. Immediately after receiving the dose, she developed redness and itching at the injection site. The subject was followed up with at 13:00 and the events had resolved. On 12 November 2008, the events were resolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. Follow-up information was received on 24 November 2008, via healthcare professional. No new information was provided.									Y	11/12/2008	11/12/2008	0	UNK	OTH	PVT		Unknown	Concomitant medications were unknown. No relevant medical history. It was unknown if the subject had previously received influenza vaccinations or experienced adverse events. The subject had no adverse events following receipt of prior immunizations. The healthcare professional reported another case, see A0756598A.		A0756602A	1						1	Immediate post-injection reaction; Injection site erythema; Injection site pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA172AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338962	01/30/2009					U	01/07/2009	This case was reported by a healthcare professional and described the occurrence of local reaction in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced an unspecified allergic reaction local reaction. At the time of reporting the outcome of the event was unspecified. The nurse reporting the event stated that out of 240 doses of FLULAVAL that she has administered, about 10 people have reported a local reaction. There were no additional details.									U				UNK	OTH	OTH		Unknown			A0756589A	1						1	Hypersensitivity; Local reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338963	01/30/2009	KY				U	01/07/2009	This case was reported by a pharmacist and described the occurrence of a product complaint in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent vaccination included PNEUMOVAX 23 (Merck) given on 28 October 2008. On 28 October 2008 the subject received a dose of FLULAVAL at 0.5 ml. Following administration of FLULAVAL, the pharmacist noted that there was a small piece of foreign matter in the vaccine vial. It was estimated that perhaps 5 subjects may have been injected with FLULAVAL from this vial. This was considered to be a product complaint. The pharmacist was not aware of any adverse events following this occurrence. The pharmacist did not have any specific information regarding the subjects involved. The pharmacist called back on 29 October 2008 to report that it was noted that a piece of the vial stopper was missing from the rim and that was the particulate that was floating in the vaccine solution. He was fairly certain that this was the particulate, but still has the vial for testing if necessary.									U	10/28/2008	10/28/2008	0	UNK	OTH	OTH		Unknown			A0756078A	1						1	Pharmaceutical product complaint	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA168AA~1~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1161X~1~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0338964	01/30/2009	CT				F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of injection site pruritus in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 1 October 2008, the subject received a dose of FLULAVAL at 0.5 ml. At an unknown time after vaccination with FLULAVAL, the subject experienced injection site pruritus. Later, the itching spread to her arms and legs. She also developed an injection site rash and then a maculopapular rash spread to her arms and legs. The itching was in the same areas as the rash. At the time of reporting, the outcome of the events was not known. Follow-up information received on 19 December 2008 via the initial reporter, indicated that there is no further information to provide concerning the reported events.									U	10/01/2008	10/01/2008	0	UNK	OTH	PVT		Unknown			A0755869A	1						1	Injection site pruritus; Injection site rash; Pruritus; Rash maculo-papular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338965	01/30/2009	CT				F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of injection site pruritus in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 1 October 2008, the subject received a dose of FLULAVAL at 0.5 ml. At an unknown time after vaccination with FLULAVAL, the subject experienced injection site pruritus. Later, the itching spread to her arms and legs. She also developed an injection site rash and then a maculopapular rash spread to her arms and legs. The itching was in the same areas as the rash. The outcome of the events was unknown at the time of reporting. Follow-up information received on 19 December 2008 via the initial reporter, indicated that there is no further information to provide concerning the reported events.									U	10/01/2008	10/01/2008	0	UNK	OTH	PVT		Unknown			A0755868A	1						1	Injection site pruritus; Injection site rash; Pruritus; Rash maculo-papular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338966	01/30/2009	CT	82.0	82		F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of injection site pruritus in a 82-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 1 October 2008 at 12:01 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. On 1 October 2008, immediately after vaccination with FLULAVAL, the subject experienced injection site pruritus. Over the next two weeks, the itching spread to her arms and legs. She also developed an injection site rash and then a maculopapular rash spread to her arms and legs. The itching was in the same areas as the rash. The subject treated herself with BENADRYL. the events were ongoing, but improved at the time of reporting. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. Follow-up information was received on 05 January 2009, via healthcare professional who reported the subject had received her shot on 01 October 2008. On 02 October 2008, she started itching. The rash started on 02 October 2008, but later in the day. The symptoms were very acute , one night the subject almost went to the emergency room. The subject was trying to stick it out to see if it would run its course but it got too bad that I had to go to my doctor. I was red all over and itching like mad. The subject's primary care physician started the subject on ATARAX. Per subject rash and itching persisted. The subject was referred to an allergist. The subject reported to the healthcare professional on 19 December 2008, that she had been seeing a dermatologist who prescribed Triamcinolone Acetonide Ointment 0.1% twice daily, which has helped with pruritus; itched for 57 days and two days later I stopped itching. Rash is gradually disappearing, but I still have a little. The subject also stated that on 17 December the she had seen an allergist, they did 96 patch test on me, they said I was allergic to glutaraldehyde (glutaral - test score 45), kathon (test score 17), neomycin (test score 3), and benzocaine (test score 5). Plan is to eventually wean off Triamcinolone ointment from twice daily to once daily to no ointment at all. The subject is planning to follow-up with allergist and dermatologist in January.									N	10/01/2008	10/01/2008	0	17 December 2008, Skin allergy test, glutaraldehyde (glutaral - test score 5), kathon (test score 17), neomycin (test score 3), and benzocaine (test score 5).	OTH	PVT	Atenolol; Lovastatin	Hyperlipidemia; Hypertension	Shoulder replacement; The subject has no relevant medical history. No known history of drug, egg or chicken allergies. The subject has previously received flu shots. Reactions, if any, were not known. The subject occasionally consumes a glass of wine and never used tobacco.		A0755860A	1						1	Allergy test positive; Erythema; Immediate post-injection reaction; Injection site pruritus; Injection site rash; Pruritus; Rash maculo-papular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338967	01/30/2009	NY	69.0	69		F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of hives in a 69-year-old female subject who was vaccinated with FLULAVAL. Concurrent medical conditions included hypertension and psoriasis. Concurrent medications include Raptiva and Crinoretic. On 24 September 2008 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. Within 1 week after vaccination with FLULAVAL, the subject developed itching and redness in her left arm. The itching and redness spread to her right arm, and then to her back, chest, stomach and legs. She saw a dermatologist and had a biopsy to determine if the rash was caused by a bacteria, virus or fungus and was told the biopsy was negative for all three and that she had hives. The subject was treated with hydroxyzine, Xyzal, Fexofenadine and three unknown creams. At the time of reporting the outcome of the events was unspecified with the exception of hives which was reportedly unresolved. In the reporter's opinion, the hives were possibly related to treatment with FLULAVAL.				Y					U	09/24/2008			The subject underwent a biopsy on an unspecified date to determine in the rash was caused by bacteria, virus or fungus. The biopsy was negative for all three, she just had hives.	MIL	MIL	Efalizumab; Crinorectic (Hydrochlorothiazide + Enalapril maleate)	Hypertension; Psoriasis	The subject has no history of adverse events following previous vaccinations.		A0755844A	1						1	Biopsy; Erythema; Pruritus; Rash; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA184AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0338968	01/30/2009	PA	77.0	77		F	01/07/2009	This case was reported by a physician and described the occurrence of diffuse itching in a 77-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included latex allergy and sore throat. On 20 October 2008, the subject received a dose of FLULAVAL (.5 ml, unknown, left arm) and was prescribed Amoxicillin for her sore throat. On 22 October 2008, 2 days after vaccination with FLULAVAL, the subject experienced diffuse itching. The physician reported that the subject came into the urgent care practice complaining of a sore throat. The physician prescribed Amoxicillin 875 mg, twice daily and FLULAVAL was given as a preventative. Two days after receiving FLULAVAL and the amoxicillin was started, the subject developed itching. The itching was diffuse and not just at the FLULAVAL injection site. The physician did not know whether the itching was due to the FLULAVAL or the Amoxicillin. The subject does have a history of latex allergy, but the physician reported he was told FLULAVAL does not contain latex. The physician did discontinue the amoxicillin on 22 October 2008 and there was a mild improvement in the itching, but the itching had not resolved. No treatment has been required. At the time of reporting, the event was improved.									N	10/20/2008	10/22/2008	2	UNK	PVT	PVT		Latex allergy; Sore throat			A0755289A	1						1	Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA158AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338969	01/30/2009	TN	68.0	68		F	01/07/2009	This case was reported by an allergy physician and described the occurrence of rash-pruritic in a 68-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 16 October 2008, the subject received a dose of FLULAVAL (unknown). On 17 October 2008, 1 day after vaccination with FLULAVAL, the subject experienced rash-pruritic. The subject was treated with steroid cream. The subject was received FLULAVAL dose at another office on 16 October 2008. On 17 October 2008, the developed a generalized rash all over. She has been using a steroid cream and the rash is getting better but it is still very pruritic. At the time of reporting the event was improved. Follow-up information was received on 15 December 2008, via healthcare professional, who reported the events resolved on an unknown date. The reporting healthcare professional considered the events possibly related to vaccination with FLULAVAL.				Y					Y	10/16/2008	10/17/2008	1	UNK	PVT	PVT		Unknown	The subject had previously received influenza vaccinations and no adverse events were reported.		A0754849A	1						1	Rash generalised; Rash pruritic	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0338970	01/30/2009	NV	29.0	29		F	01/27/2009	This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 29-year-old female subject who was vaccinated with FLULAVAL. On 14 October 2008 at 16:30, the subject received a dose of FLULAVAL (.5ml, unknown, right arm). At an unspecified time after vaccination with FLULAVAL, the subject experienced swelling injection site and injection site redness. At the time of reporting the outcome of the events were unspecified. Follow-up information was received on 24 November 2008, via healthcare professional. No new information was provided.									U	10/14/2008			UNK	PVT	PVT		Unknown	No concomitant medications or relevant medical history. The subject had not previously received influenza vaccinations. No adverse events were reported with previous vaccinations. The healthcare professional reported another case of injection site reaction, see case A0754693A.		A0754696A	1						1	Injection site erythema; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLA179AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338971	01/30/2009	NV	68.0	68		F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of injection site pruritis in a 68-year-old female subject who was vaccinated with FLULAVAL. On 13 October 2008, the subject received unspecified dose of FLULAVAL (.5ml, unknown, left arm). On 13 October 2008, within minutes of vaccination with FLULAVAL, the subject experienced injection site pruritis and injection site redness; 30 minutes later, she experienced a lump at injection site and injection site pain. The subject was treated with BENADRYL and antibiotics for five days. The subject has not reported any further problems. At the time of reporting the outcome of the events were unspecified. Follow-up information was received on 24 November 2008, via healthcare professional. No new information was provided.				Y					U	10/13/2008	10/13/2008	0	UNK	PVT	PVT		Unknown	No concomitant medications or relevant medical history. The subject had previously received influenza vaccinations and no adverse events were reported. No adverse events were reported with previous vaccinations. The healthcare professional reported another case of injection site reaction, see case A0754696A.		A0754693A	1						1	Injection site erythema; Injection site mass; Injection site pain; Injection site pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLA179AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0338972	01/30/2009	AZ	58.0	58		F	01/07/2009	This case was reported by a consumer and described the occurrence of ears clogged in a 58-year-old female subject who was vaccinated with FLULAVAL. A physician or other healthcare professional has not verified this report. Concurrent medical conditions included asthma and food allergy. Concurrent medications included NEXIUM, ADVAIR and CARDIZEM. On 16  October 2008 at 13:30 the subject received unspecified dose of FLULAVAL at 0.5ml in the left arm. On 16 October 2008, 2 hours after vaccination with FLULAVAL, the subject's ears began clogging. She took BENADRYL. Then the roof of her mouth, which is usually smooth, puckered. The subject also began to experience laryngitis on 16 October 2008. The subject began to recognize that she may be having an allergic reaction. At 20:00 the subject took another BENADRYL and went to the emergency room. In the emergency room she received a PREDNISONE burst and prescribed oral PREDNISONE, PEPCID and BENADRYL. The consumer stated that these medications only temporarily relieve the symptoms. At the time of reporting the outcome of the events was unspecified.				Y					U	10/16/2008	10/16/2008	0	UNK	PVT	OTH	Esomeprazole; HYZAAR; (Hydrochlorothiazide+Losartan potassium+potassium salt); Diltiazem  hydrochloride	Asthma; Food allergy	The subject has a history of numerous food allergies. It was reported that when she experiences a reaction, her ears clog, her throat becomes like sand paper, the roof of her mouth puckers and her tongue swells. The subject has not previously received any flu shots.		A0754692A	1						1	Dry mouth; Ear discomfort; Laryngitis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0338973	01/30/2009	LA	20.0	20		F	01/07/2009	This case was reported by a physician and described the occurrence of low temperature in a 20-year-old female subject who was vaccinated with FLULAVAL. The subject's medical history included acne and depression. The subject had no adverse events following receipt of previous immunizations. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. Concurrent medications included LEXAPRO, RETIN A and BENADRYL. The subject received no other immunizations on the date of receipt of FLULAVAL. On 19 October 2008 at 9:00 am, the subject received 1st dose of FLULAVAL (.5 ml, unknown, left arm). On 19 October 2008 at 6:00 pm, 9 hours after vaccination with FLULAVAL, the subject experienced low temperature, chills, muscle pain, rash, nausea, vomiting and itching. At the time of reporting the events were improved. The physician considered the events were possible related to vaccination with FLULAVAL. The physician reported that the subject is his daughter that is a nursing student. The physician reported that his daughter's temperature was as low as 95.0 degrees Fahrenheit.									N	10/19/2008	10/19/2008	0	Body temperature, 10/19/2008, 95 degrees, F	PVT	PVT	LEXAPRO; Tretinoin; Diphenhydramine HCl	Unknown	Acne; depression; The subject had no adverse events following receipt of previous immunizations. The subject had received influenza virus vaccine in previous years with no subsequent adverse events.		A0754502A	1						1	Body temperature decreased; Chills; Myalgia; Nausea; Pruritus; Rash; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA173AA~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338974	01/30/2009	MD	52.0	52		M	01/07/2009	This case was reported by a physician and described the occurrence of incorrect storage of drug in a 52-year-old male subject who was vaccinated with FLULAVAL. The reporter is the subject. The subject received no other vaccines on the date of receipt of FLULAVAL. There were no concurrent medication. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unknown). At an unspecified time following the receipt of INFLUEZA vaccine (unknown), the subject experienced a sore arm. The outcome of the sore arm was not reported. On 19 October 2008 at 1:00 pm, the subject received 1st dose of FLULAVAL (.5ml, unknown, left arm), and experienced incorrect storage of drug. The physician reported that, on 19 October 2008, the subject was administered FLULAVAL that had possibly been stored below recommended temperatures for about 2 hours. The physician reported that one other subject received FLULAVAL that had possibly been stored below recommended temperatures for about 2 hours. Please see case A0754351A.									U	10/19/2008	10/19/2008	0	UNK	PVT	PVT	No concurrent medication	Unknown	No relevant medical history.		A0754333A	1						1	Medication error; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA158AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338975	01/30/2009	FL	54.0			M	01/07/2009	This was reported by a healthcare professional via a inside sales representative and described the occurrence of black spot at injection site in a subject of unspecified age and gender who was vaccinated with FLULAVAL. On an unspecified date the subject received unspecified dose of FLULAVAL at 0.5ml. At an unspecified time after vaccination with FLULAVAL, the subject developed a black spot about the size of a half dollar at the injection site. This was also considered to be a product complaint as the reporter expressed concern with the quality of the FLULAVAL administered. At the time of reporting the outcome of the black spot was unspecified. This was second call regarding this sort of adverse event from this inside sales representative that spoke with this facility. Previous events were filed with a QA report number of UV20080143. The facility called this inside sales representative stating that she had not been contacted regarding the first QA. She decided to use the product on another subject and they contacted her stating they had a half dollar size black spot at the injection site. The facility was concerned with the quality of the FLULAVAL. Linked cases include: A0752107A, A0752229A, A0752230A, A0752231A, A0752232A and A0752233A. Follow- up information received on 07 November 2008, via healthcare professional who reported the 54-year-old male subject experienced an additional adverse reaction was reported, details not provided. The events occurred on 22 October 2008 and resolved on 26 October 2008. A quality statement received on 24 October 2008 indicated that no deviation that could be linked to the complaint had been highlighted. Biologicals therefore confirmed that this batch is suitable for vaccination purposes.									Y		10/22/2008		UNK	PVT	OTH		Unknown	Linked cases include: A0752107A, A0752229A, A0752230A, A0752231A, A0752232A and A0752233A. The subject previously received influenza vaccination on 13 November 2007. No adverse events were reported with previous vaccinations. The subject does not use tobacco or alcohol.		A0754297A	1						1	Adverse reaction; Injection site discolouration; Pharmaceutical product complaint	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA188AA~2~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338982	01/30/2009	CA	65.0	65		F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of injection site redness in a 65-year-old female subject who was vaccinated with FLULAVAL. The subject's medical history included cholesterol, hypertension, and allergy to BIAXIN. Concurrent medications included TOPROL, LIPITOR and Aspirin (Baby ASA). On 14 October 2008 the subject received unspecified dose of FLULAVAL (unknown, unknown arm). In October 2008, less than one week after vaccination with FLULAVAL, the subject experienced injection site redness, injection site pruritis and warmness to touch at injection site. At the time of reporting the events were unresolved. The healthcare professional considered the injection site pruritis and warmness to touch at injection site were probably related to vaccination with FLULAVAL. An office manager reports that an adult female reported redness, itching and warm to touch in her arm following FLULAVAL injection on Oct 14th.  The office manager reported that one other subject experienced adverse events following administration of FLULAVAL. Please see case A0754164A.  Follow-up information was reported on 10 November 2008, via healthcare professional who reported the subject on 14 October 2008 the subject received unspecified dose of FLULAVAL (unknown, left deltoid). On 15 October 2008, 1 day after vaccination with FLULAVAL, the subject experienced redness measuring 8 centimeters by 4.5 centimeters (very large), red and indurated skin local reaction; the subject had no bronchospasm. The subject has had flu vaccines for years and never had a reaction before. The subject was advised to use cortisone cream at injection site and BENADRYL two 5mg, once daily for itching and two ADVIL three times daily for inflammation. On 31 October 2008, the events were resolved. The subject was advised thimerasol from flu vaccine. The healthcare professional considered the events were related to vaccination with FLULAVAL.									Y	10/14/2008	10/15/2008	1	UNK	PVT	PVT	Metoprolol succinate; Atorvastatin calcium; Aspirin	Unknown	Allergy to BIAXIN; cholesterol; hypertension  The subject has received flu vaccine every year without a reaction. The subject abstains from alcohol and uses tobacco products occasionally.		A0754167A	1						1	Induration; Injection site erythema; Injection site inflammation; Injection site pruritus; Injection site warmth; Local reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA185AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338983	01/30/2009	CA	21.0	21		F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of injection site redness in a 21-year-old female subject who was vaccinated with FLULAVAL. Medical history included no allergies. There were no concurrent medications. On 13 October 2008 the subject received unspecified dose of FLULAVAL (unknown, unknown arm). In October 20008, less than one week after vaccination with FLULAVAL, the subject experienced injection site redness, injection site pruritis and warm to touch at injection site. The subject was treated with ibuprofen. At the time of reporting the events were unresolved. The healthcare professional considered the injection site pruritis was probably related to vaccination with FLULAVAL. An office manager reported that an adult female reported redness, itching and warm to touch in her arm following FLULAVAL injection on 13 October 2008 the subject received unspecified dose of FLULAVAL (unknown, left deltoid). On 14 October 2008, 1 day after vaccination with FLULAVAL, the subject experienced no difficult breathing, local skin reaction with redness, induration and swelling. The subject actually got flu like symptoms one day after the injection. The subject also noted fever and myalgia with tightness in her neck. The subject's warmness to touch at injection site measured 3 centimeters by 3.5 centimeters. The flu like symptoms for three days after injection. The subject was advised she is probably allergic to thimerasol and she should not receive another flu vaccine. The healthcare professional considered the events were related to vaccination with FLULAVAL.									N	10/13/2008	10/14/2008	1	UNK	PVT	PVT		Unknown	No allergies. The subject uses alcohol socially and no tobacco products.		A0754164A	1						1	Erythema; Induration; Influenza like illness; Injection site erythema; Injection site pruritus; Injection site warmth; Local reaction; Muscle tightness; Myalgia; Pyrexia; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA185AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338984	01/30/2009	DC	64.0	64		F	01/07/2009	This case was reported by a consumer and described the occurrence of nerve disturbance in a 64-year-old female subject who was vaccinated with FLULAVAL. A physician or other health care professional has not verified this report. The subject's medical history included reaction to preservatives. This subject had no adverse events following receipt of prior immunizations with influenza virus vaccines. The subject reported that she did not have any adverse events following receipt of previous vaccinations, but noted that she does not get vaccinations. Concurrent medications included CARDIZEM and TOPROL. No other vaccinations were administered on the date of receipt of FLULAVAL. On 14 October 2008 at 11:30 am the subject received the one and only dose of FLULAVAL (unknown, right arm). On 15 October 2008, 1 day after vaccination with FLULAVAL, the subject experienced nerve disturbance described as nerve endings felt weird, diarrhea and total exhaustion. The subject consulted a healthcare professional regarding the event. At the time of reporting the outcome of the events was resolved. The subject reported that the exhaustion is not flu-like. She could not further describe what she meant by her nerve endings feeling weird. The consumer reported that one other subject experienced adverse events following receipt of FLULAVAL. Please see case A0753992A.									Y	10/14/2008	10/15/2008	1	UNK	PVT	OTH	Diltiazem hydrochloride; Metoprolol succinate	Unknown	Reaction to preservatives.  This subject had no adverse events following receipt of prior immunizations with influenza virus vaccines. The subject reported that she did not have any adverse events following receipt of previous vaccinations, but noted that she does not get vaccinations.		A0753586A	1						1	Diarrhoea; Fatigue; Nervous system disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338985	01/30/2009	MN	34.0	34		F	01/07/2009	This case was reported by a consumer and described the occurrence of injection site redness in a 34-year-old female subject who was vaccinated with FLULAVAL. The reporter is the subject. A physician or other health care professional has not verified the report. The subject had no adverse events following receipt of prior immunizations (including no adverse events with prior immunizations with influenza virus vaccines) and no relevant medical history. Concurrent medications included SYNTHROID and NEURONTIN. On 14 October 2008 in the evening after 5:00 pm, the subject received unspecified dose of FLULAVAL (.5 ml, unknown, right arm). On 14 October 2008, within one hour after vaccination with FLULAVAL, the subject experienced injection site redness. On 15 October 2008, one day after vaccination with FLULAVAL, she experienced allergic reaction. On 16 October 2008, two days after vaccination with FLULAVAL, she experienced a larger area of redness. The subject was seen at a doctor's office. At the time of reporting the events were improved. Follow-up information received on 05 January 2009 indicated that the events of injection site redness, allergic reaction and area of redness began on 14 October 2008 and resolved ten days later on 23 October 2008. In the reporter's opinion, these events were possibly related to treatment with FLULAVAL.				Y					Y	10/14/2008	10/14/2008	0	UNK	PVT	OTH	Thyroxine sodium; Gabapentin	Unknown	No relevant medical history. The subject had no adverse events following receipt of prior immunizations (including no adverse events with prior immuninzations with influenza virus vaccines).		A0753954A	1						1	Erythema; Hypersensitivity; Injection site erythema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ASLLA179AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0338986	01/30/2009	CT	62.0	62		F	01/07/2009	This case was reported by a physician and described the occurrence of allergic reaction in a 62-year-old female subject who was vaccinated with FLULAVAL. Concurrent medical conditions included abdominal pain and urinary tract infection. Concurrent medications included COUMADIN, LIPITOR, ATENOLOL, XANAX and CIPRO. On 15 October 2008, the subject received a dose of FLULAVAL (.5 ml, intramuscular, right arm). On 15 October 2008, within six to eight hours after vaccination with FLULAVAL, the subject experienced allergic reaction, extensive swelling of vaccinated limb, injection site redness and injection site tenderness.  The subject's bladder symptoms started one week prior to receiving FLULAVAL. The subject came into the physician's office on 15 October 2008 with abdominal pain and a urinary tract infection was diagnosed. There was no fever so the physician gave FLULAVAL while the subject was in the office and prescribed CIPRO for the UTI. The subject had taken CIPRO previously for UTI with no reaction (thus CIPRO is not suspected). The physician reported a moderately severe swelling reaction to FLULAVAL, which included redness and tenderness and is thought to be due to an allergic reaction. The physician described the swelling as impressive. Per the subject, these events began within six to eight hours after the injection. The physician did not examine these events until the next morning, which was greater than 24 hours after the onset. The FLULAVAL injection was given in triceps muscle, the swelling began one inch above the injection site, and extended eight to nine inches down toward elbow, the width of the swelling is three to four inches in diameter. The physician has not prescribed any treatment such as steroids, because she does not want to interfere with the immune response of FLULAVAL. The physician expects that these events will resolve without treatment. The subject reported that the events are still worsening but the physician stated, that is to be expected as allergic reactions usually so not peak until 48 hours. The physician is question whether the subject should receive flu vaccines in the future due to these events. The physician has already submitted this report to VAERS. At the time of reporting, the events were worse. The physician considered the events were probably related to vaccination with FLULAVAL.									U	10/15/2008	10/15/2008	0	UNK	PVT	PVT	Warfarin sodium; Atorvastatin calcium; ATENOLO; Alprazolam; Ciprofloxacin HC1	Abdominal pain; urinary tract infection;	Allergies: water pill caused a rash in past. The subject had previously received influenza vaccinations and no adverse events were reported. The subject had an unknown reaction to PNEUMOVAX in the past.		A0753917A	1						1	Hypersensitivity; Injection site erythema; Injection site pain; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA179AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338987	01/30/2009	NM	34.0	34		F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of arm redness in a 34- year- old female subject who was vaccinated with FLULAVAL. The subject had no relevant medical history. There were no concurrent medications and the subject received no other vaccinations on the date of receipt of FLULAVAL. On 13 October 2008 the subject received unspecified dose of FLULAVAL (.5 ml, unknown, right arm). Less than one week after vaccination with FLULAVAL, on an unspecified date in October 2008, the subject experienced arms redness, swelling arm, skin bruise on arm (ecchymosis) and arm felt warm to touch. Medical attention was required at a doctor's office. The subject was treated with KEFLEX. At the time of reporting the arms redness, swelling arm, ecchymosis were improved and the outcome of the warm to touch was unspecified. On 16 October 2008, a nurse in a clinic reported a female in their office noted that she had redness, swelling, warmness to touch in her arm following FLULAVAL injection. One of the docs in the clinic treated her with a rx of KEFLEX.				Y					U	10/13/2008			UNK	OTH	OTH		Unknown			A0753779A	1						1	Contusion; Ecchymosis; Erythema; Oedema peripheral; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA171AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0338988	01/30/2009	IN	37.0	37		F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of high fever in a 37-year-old female subject who was vaccinated with FLULAVAL , pneumococcal vaccine and unspecified PNEUMOVAX. Concurrent medical conditions included chronic back pin. Concurrent medications included NSAIDS. On 13 October 2008 at 09:30, the subject received a dose of FLULAVAL (.5 ml, unknown, unknown arm) and her 1st dose of PNEUMOVAX (unknown, unknown arm). On 15 October 2008, 2 days after vaccination with FLULAVAL, and PNEUMOVAX, the subject experienced high fever, arm swollen, arms redness and hot to touch. The reporting healthcare professional stated the subject received a FLULAVAL and PNEUMOVAX vaccine on the same day and in the same arm. After two days, the subject reported high fever, and a red swollen arm that was hot to touch. She was seen at the emergency department. No other information was provided. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL and PNEUMOVAX.				Y					N	10/13/2008	10/15/2008	2	UNK	PVT	PVT	NSAID	Chronic back pain	The subject has chronic back pain is under the care of pain management clinic. The subject had previously received influenza vaccinations and no adverse events were reported. No adverse events were reported following receipt of prior immunizations		A0753700A	1						1	Erythema; Oedema peripheral; Pyrexia; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA183AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0867X~1~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0338990	01/30/2009	AZ	8.0			F	01/07/2009	This case was reported by a mother of a consumer and described the occurrence of injection site soreness in a 8-year-old female subject who was vaccinated with FLULAVAL. A physician or other health care professional has not verified this report. There were no concurrent medications. On 8 October 2008 the subject received unspecified dose of FLULAVAL at 0.5 ml. On 8 October 2008, less than one day after vaccination with FLULAVAL, the subject experienced injection site soreness. Administration of FLULAVAL to this subject was considered to be a drug administration error as FLULAVAL is not indicated for use in subjects under the age of 18 years. At the time of reporting, injection site soreness was resolved. Follow-up via the mother indicated that the subject has experienced no other side effects.									Y	10/08/2008	10/08/2008	0	UNK	OTH	OTH	No concurrent medication	Unknown	The subject has no relevant medical history.		A0753417A	1						1	Inappropriate schedule of drug administration; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338991	01/30/2009	AZ	13.0			M	01/07/2009	This case was reported by a mother of a consumer and described the occurrence of injection site soreness in a 13-year-old male subject who was vaccinated with FLULAVAL. A physician or other health care professional hs not verified this report. There were no concurrent medications. On 8 October 2008, the subject received unspecified dose of FLULAVAL at 0.5 ml. On 8 October 2008, less than one day after vaccination with FLULAVAL the subject experienced injection site soreness. Administration of FLULAVAL to this subject was considered to be a drug administration error as FLULAVAL is not indicated for use in subjects under the age of 18 years. At the time of reporting, injection site soreness was resolved. Follow-up via the mother indicated that the subject has experienced no other side effects.									Y	10/08/2008	10/08/2008	0	UNK	OTH	OTH		Unknown			A0753416A	1						1	Inappropriate schedule of drug administration; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338992	01/30/2009	AZ	17.0			M	01/07/2009	This case was reported by a mother of a consumer and described the occurrence of injection site soreness in a 17-year-old male who was vaccinated with FLULAVAK. A physician or other health care professional has not verified this report. There were no concurrent medications. On 8 October 2008, the subject received unspecified dose of FLULAVAL at 0.5 ml. On 8 October 2008, less than one day after vaccination with FLULAVAL, the subject experienced injection site soreness. Administration of FLULAVAL to this subject was considered to be a drug administration error as FLULAVAL is not indicated for use in subjects under the age of 18 years. At the time of reporting, injection site soreness was resolved. Follow-up via mother indicated that the subject has experienced no other side effects.									Y	10/08/2008	10/08/2008	0	UNK	OTH	OTH		Unknown			A0753411A	1						1	Inappropriate schedule of drug administration; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338993	01/30/2009	TX	42.0	42		F	01/07/2009	This case was reported by a healthcare professional (also the consumer) and described the occurrence of chest rash in a 42-year-old female subject who was vaccinated with FLULAVAL. Concurrent medications included TOPAMAX, Propranolol, PROTONIX and LIPITOR. On the morning of 2 October 2008 the subject received a dose of FLULAVAL at 0.5 ml in the right arm. Later that evening, th subject developed a rash on chest that spread to the rest of her body. The reporter/nurse stated that the rash worsened over the first three days and was unresolved at the time of reporting. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL.									N	10/02/2008	10/02/2008	0	UNK	PVT	PVT	Topiramate; Propranolol hydrochloride; Pantoprazole; Atorvastatin calcium	Unknown	The subject has previously received flu shots with no history of reactions. Additionally, the subject has no history of adverse events following previous vaccinations.		A0752929A	1						1	Rash generalised	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA154AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338995	01/30/2009					U	01/07/2009	This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL. On 1 October 2008 the subject received unspecified dose of FLULAVAL (unknown). At an Unspecified time after vaccination with FLULAVAL, the subject experienced extreme injection site redness and extreme injection site soreness. At the time of reporting the outcome of the events was unspecified. The reporter stated that this event occurred in three additional subjects. Linked cases include: A0752833A, A0752835A and A0752836A.										10/01/2008			UNK	PVT	PVT		Unknown	The reporter stated that this event occurred in three additional subjects. Linked cases include: A0752833A, A0752835A and A0752836A.		A0752837A	1						1	Injection site erythema; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA208AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338996	01/30/2009					U	01/07/2009	This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL. On 1 October 2008 the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced extreme injection site redness and extreme injection site soreness. At the the time of reporting the outcome of the events was unspecified. The reporter stated that this event occurred in three additional subjects. Linked cases include: A0752833A, A0752835A and A0752837A.									U	10/01/2008			UNK	PVT	PVT		Unknown	The reporter stated that this event occurred in three additional subjects. Linked cases include: A0752833A, A0752835A and A0752837A		A0752836A	1						1	Injection site erythema; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA208AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0339055	01/30/2009	VA				U	01/07/2009	This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 1 October 2008 the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced extreme injection site redness and extreme injection site soreness. At the time of reporting the outcome of the events was unspecified. The reporter stated that this event occurred in three additional subjects. Linked cases include: A0752833A, A0752836A and A0752837A.									U	10/01/2008			UNK	PVT	PVT		Unknown	The reporter stated that this event occurred in three additional subjects. Linked cases include: A0752833A, A0752836A and A0752837A.		A0752835A	1						1	Injection site erythema; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA208AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0339056	01/30/2009	VA	81.0	81		F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 1 October 2008 the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced extreme injection site redness and extreme injection site soreness. At the time of reporting the outcome of the events was unspecified. The reporter stated that this event occurred in three additional subjects. Linked cases include: A0752835A, A0752836A and A0752837A. Follow-up information received on 31 October 2008 indicated that the subject was an 81 year old female. The events of injection site redness and soreness began 4 days following administration of FLULAVAL and resolved 4 days later on 08 October 2008. In the reporter's opinion, the events were considered related to treatment with FLULAVAL.									Y	10/01/2008	10/05/2008	4	UNK	PVT	PVT		Unknown	The reporter stated that this event occurred in three additional subjects. Linked cases include: A0752835A, A0752836A and A0752837A.		A0752833A	1						1	Injection site erythema; Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA208AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0339057	01/30/2009	KY	33.0			F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of injection site redness in a 33-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). There were no concomitant medications. On 1 October 2008 the subject received a dose of FLULAVAL at 0.5 ml, subcutaneously, in the left arm. On 1 October 2008, within a few hours following vaccination with FLULAVAL, the subject experienced injection site redness. The area of redness was about 1 inch in diameter and resolved on 4 October 2008. It was also noted that the FLULAVAL was administered via the wrong route. The vaccine should have been administered intramuscularly. The healthcare professional considered that the injection site redness was possibly related to vaccination with FLULAVAL.									Y	10/01/2008	10/01/2008	0	UNK	PUB	OTH	No concurrent medication	Unknown	The subject had no relevant medical history and no known history of adverse events following previous vaccinations.		A0752564A	1						1	Incorrect route of drug administration; Injection site erythema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA158AA~1~SC~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0339058	01/30/2009					U	01/07/2009	This case was reported by a healthcare professional that described the occurrence of injection site burning in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date, the subject received an unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced injection site burning and neck rash. At the time of reporting, the outcome of the events was unspecified. No other information was known by the reporter, and no patient specific identifiers were provided.									U				UNK	OTH	OTH		Unknown	A0752498A was one of two cases reported by the same healthcare professional. Please reference report A0752492A.		A0752498A	1						1	Injection site irritation; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0339059	01/30/2009					U	01/07/2009	This case was reported by a healthcare professional that described the occurrence of injection site burning in four to five subjects of unspecified ages and genders who were vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date(s), the subjects received unspecified doses of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subjects experienced injection site burning. An employee reported that four to five subjects experienced burning at the injection site following FLULAVAL vaccine. At the time of reporting, the outcome of the events were unspecified. No other information was known by the reporter, and no patient specific identifiers were provided.									U				UNK	OTH	OTH		Unknown	A0752492A was one of two cases reported by the same healthcare professional. Please reference report A0752498A.		A0752492A	1						1	Injection site irritation	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0339060	01/30/2009	UT				F	01/07/2009	This case was reported by a physician and described the occurrence of swelling arm in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On October 2nd or 3rd, 2008 the subject received a dose of FLULAVAL in the right arm. At an unspecified time after vaccination with FLULAVAL, the subject experienced swelling in the right arm and heat and pain in the right arm. At the time of reporting the outcome of the events was unspecified.				Y					U	10/02/2008			UNK	OTH	OTH		Unknown	The subject has no history of allergies.		A0752279A	1						1	Oedema peripheral; Pain in extremity; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0339061	01/30/2009	FL				M	01/07/2009	This case was reported by a healthcare professional and described the occurrence of arm pain in an adult male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2008, approximately one week prior to reporting, the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced arm pain, arm redness and arm swelling. This was also considered to be a product complaint as the reporter stated that 5 additional subjects reported similar events following administration of the same lot of FLULAVAL. At the time of reporting the outcome of the events was unspecified. Linked cases include: A0752107A, A0752229A, A0752230A, A0752231A, A0752232A and A0754297A. A quality statement received on 24 October 2008 indicated that no deviation that could be linked to the complaint had been highlighted. GlaxoSmithKline Biologicals therefore confirmed that this batch is suitable for vaccination purposes.				Y					U				UNK	PVT	OTH		Unknown	Five additional subjects experienced similar symptoms. Linked cases include: A0752107A, A0752229A, A0752230A, A0752231A, A0752232A and A0754297A.		A0752233A	1						1	Erythema; Oedema peripheral; Pain in extremity; Pharmaceutical product complaint	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA188AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0339062	01/30/2009	FL				M	01/07/2009	This case was reported by a healthcare professional and described the occurrence of arm pain in an adult male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2008, approximately one week prior to reporting, the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced arm pain, arm redness and arm swelling. This was also considered to be a product complaint as the reporter stated that 5 additional subjects reported similar events following administration of the same lot of FLULAVAL. At the time of reporting the outcome of the events was unspecified. Linked cases include: A0752107A, A0752229A, A0752230A, A0752231A, A0752233A and A0754297A. A quality statement received on 24 October 2008 indicated that no deviation that could be linked to the complaint had been highlighted. GlaxoSmithKline Biologicals therefore confirmed that this batch is suitable for vaccination purposes.				Y					U				UNK	PVT	OTH		Unknown	Five additional subjects experienced similar symptoms. Linked cases include: A0752107A, A0752229A, A0752230A, A0752231A, A0752233A and A0754297A.		A0752232A	1						1	Erythema; Oedema peripheral; Pain in extremity; Pharmaceutical product complaint	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA188AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0339063	01/30/2009	FL				F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of arm pain in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2008, approximately one week prior to reporting, the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced arm pain, arm redness and arm swelling. This was also considered to be a product complaint as the reporter stated that 5 additional subjects reported similar events following administration of the same lot of FLULAVAL. At the time of reporting the outcome of the events was unspecified. Linked cases include: A0752107A, A0752229A, A0752230A, A0752232A, A0752233A and A0754297A. A quality statement received on 24 October 2008 indicated that no deviation that could be linked to the complaint had been highlighted. GlaxoSmithKline Biologicals therefore confirmed that this batch is suitable for vaccination purposes.				Y					U				UNK	PVT	OTH		Unknown	Five additional subjects experienced similar symptoms. Linked cases include: A0752107A, A0752229A, A0752230A, A0752232A, A0752233A and A0754297A.		A0752231A	1						1	Erythema; Oedema peripheral; Pain in extremity; Pharmaceutical product complaint	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA188AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0339064	01/30/2009	FL				F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of arm pain in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2008, approximately one week prior to reporting, the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced arm pain, arm redness and arm swelling. This was also considered to be a product complaint as the reporter stated that 5 additional subjects reported similar events following administration of the same lot of FLULAVAL. At the time of reporting the outcome of the events was unspecified. Linked cases include: A0752107A, A0752229A, A0752231A, A0752232A, A0752233A and A0754297A. A quality statement received on 24 October 2008 indicated that no deviation that could be linked to the complaint had been highlighted. GlaxoSmithKline Biologicals therefore confirmed that this batch is suitable for vaccination purposes.				Y					U				UNK	PVT	OTH		Unknown	Five additional subjects experienced similar symptoms. Linked cases include: A0752107A, A0752229A, A0752231A, A0752232A, A0752233A and A0754297A.		A0752230A	1						1	Erythema; Oedema peripheral; Pain in extremity; Pharmaceutical product complaint	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA188AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0339065	01/30/2009	FL				F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of arm pain in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2008, approximately one week prior to reporting, the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced arm pain, arm redness, arm swelling and vomiting. This was also considered to be a product complaint as the reporter stated that 5 additional subjects reported similar events following administration of the same lot of FLULAVAL. At the time of reporting the outcome of the events was unspecified. Linked cases include: A0752107A, A0752230A, A0752231A, A0752232A, A0752233A and A0754297A. A quality statement received on 24 October 2008 indicated that no deviation that could be linked to the complaint had been highlighted. GlaxoSmithKline Biologicals therefore confirmed that this batch is suitable for vaccination purposes.				Y					U				UNK	PVT	OTH		Unknown	Five additional subjects experienced similar symptoms. Linked cases include: A0752107A, A0752230A, A0752231A, A0752232A, A0752233A and A0754297A.		A0752229A	1						1	Erythema; Oedema peripheral; Pain in extremity; Pharmaceutical product complaint; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA188AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0339066	01/30/2009	FL				F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of arm pain in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2008, approximately one week prior to reporting, the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced arm pain, arm redness, arm swelling and vomiting. This was also considered to be a product complaint as the reporter stated that 5 additional subjects reported similar events following administration of the same lot of FLULAVAL. At the time of reporting the outcome of the events was unspecified. Linked cases include: A0752229A, A0752230A, A0752231A, A0752232A, A0752233A and A0754297A. A quality statement received on 24 October 2008 indicated that no deviation that could be linked to the complaint had been highlighted. GlaxoSmithKline Biologicals therefore confirmed that this batch is suitable for vaccination purposes.				Y					U				UNK	PVT	OTH		Unknown	Five additional subjects experienced similar events. Linked cases include: A0752229A, A0752230A, A0752231A, A0752232A, A0752233A and A0754297A.		A0752107A	1						1	Erythema; Oedema peripheral; Pain in extremity; Pharmaceutical product complaint; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA188AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0339067	01/30/2009	CO				M	01/07/2009	This case was reported by a healthcare professional and described the occurrence of injection site soreness in an adult male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2008, about one week prior to this report, the subject received a dose of FLULAVAL at 0.5 ml in the left arm. One day following vaccination with FLULAVAL, the subject experienced injection site soreness. The subject was instructed to put cold packs on the affected area. The event resolved. The reporter felt that the event was probably related to treatment with FLULAVAL.									Y					PVT	PVT		Unknown	The subject has received flu vaccine previously with no reactions reported.		A0751413A	1						1	Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA185AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0339068	01/30/2009	CO				F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of injection site soreness in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2008, about one week prior to this report, the subject received a dose of FLULAVAL at 0.5 ml in the left arm. One day following vaccination with FLULAVAL, the subject experienced injection site soreness. The subject was instructed to put cold packs on the affected area. The event resolved. The reporter felt that the event was probably related to treatment with FLULAVAL.									Y					PVT	PVT		Unknown	The subject has received flu vaccine previously with no reactions reported.		A0751412A	1						1	Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA185AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0339069	01/30/2009	OH	15.0	15		F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of lost consciousness in a 15-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). There were no concurrent medications. On 4 October 2008 at 10:45 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. Immediately after vaccination with FLULAVAL, the subject reported that things sounded funny and looked funny. An emergency room visit was noted. The events resolved the same day. The healthcare professional considered the events were unrelated to vaccination with FLULAVAL. This was also considered to be a case of medication error as FLULAVAL is not indicated for use in children. Follow-up information received on 19 November 2008, via healthcare professional considered the events probably related to vaccination with FLULAVAL and associated them to erroneous administration, being FLULAVAL is not indication for those under 18-years old.				Y					Y	10/04/2008	10/04/2008	0	UNK	OTH	PVT	No concurrent medications	Unknown	The subject has no relevant medical history.		A0751369A	1						1	Hearing impaired; Immediate post-injection reaction; Inappropriate schedule of drug administration; Loss of consciousness; Visual impairment	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA207AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0339071	01/30/2009	NC	39.0	39		F	01/07/2009	This case was reported by a pharmacist and described the occurrence of radiating pain in the arm in a 39-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included Levothyroxine, Spironolactone, Desonide cream, Clindamycin lotion, LEXAPRO, AMBIEN, XANAX, FINACEA and METROGEL. On 17 November 2008 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. After receiving FLULAVAL, the subject began to experience radiating pain in the same arm where the injection was given (the left arm). The pain reportedly radiated up and down the left arm and was not just at the injection site. The subject stated that the radiating pain started 1 to 2 days (November 2008) following FLULAVAL administration, but a specific date was not provided. The subject had described the pain as nerve-related pain. She treated herself with ibuprofen 800 mg as needed. The ibuprofen dulled the pain, but did not make it go away. At the time of reporting, the events had improved over the 2 to 3 weeks prior. The subject was still uncomfortable. The subject denied any recent change in activity level or heavy lifting that might have contributed to these events. The pharmacist considered the events were possibly related to vaccination with FLULAVAL. Follow-up information received on 05 January 2009 indicated that the events began on 19 November 2008. At the time of follow-up, the events were improved and still considered to be possibly related to treatment with FLULAVAL.									U	11/17/2008	11/19/2008	2	UNK	PVT	PVT	Thyroxine sodium; Spironolactone; Desonide; Clindamycin; LEXAPRO; Zolpidem tartrate; Alprazolam; Azelaic acid; Metronidazole	Unknown	The subject has no relevant medical history. She has previously received flu shots with no problems. There is not history of adverse events following previous vaccinations.		A0760091A	1						1	Neuralgia; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA171AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0339072	01/30/2009	IN	25.0	25		F	01/07/2009	This case was reported by a pharmacist and described the occurrence of increase in migraine in a 25-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included migraine. Concurrent medications included TREXIMET. On 1 December 2008 at 17:10 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. On 4 December 2008, 3 days after vaccination with FLULAVAL, the subject experienced increase in migraine (worsening) and bruising at the injection site. She also noted new bruising on her legs the same day. Increase in migraines and injection site bruising was improved at the time of reporting. The outcome of bruising on the legs was not reported.									U	12/01/2008	12/04/2008	3	UNK	PUB	OTH	Sumatriptan succinate + Naproxen	Migraine	The subject has previously received flu vaccine and experienced flu-like symptoms.		A0760086A	1						1	Condition aggravated; Contusion; Injection site haematoma; Migraine	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA192AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0339073	01/30/2009					F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of nausea in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 28 November 2008, the subject received a dose of FLULAVAL (.5 unknown, unknown). On 28 November 2008, 4 hours after vaccination with FLULAVAL, the subject experienced nausea and diarrhea. The healthcare professional reported that a female subject received a FLULAVAL vaccination on 28 November 2008 and within four hours after the vaccination, she developed nausea and diarrhea. The healthcare professional stated that she was doing better and no further adverse events were reported. The healthcare professional refused to provide any details. At the time of reporting the events were resolved.									Y	11/28/2008	11/28/2008	0	UNK	OTH	OTH		Unknown			A0759673A	1						1	Diarrhoea; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0339074	01/30/2009	NC	39.0	39		F	01/07/2009	This case was reported by a consumer and described the occurrence of red rash on stomach in a 39-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included drug allergy. Concurrent medications included Birth control. On 13 November 2008 at 13:00 the subject received a dose of FLULAVAL in the right arm. Five hours after vaccination with FLULAVAL, the subject experienced a red rash on the stomach and itching. The subject started treatment with BENADRYL on 19 November 2008. At the time of reporting the events were improved.									N	11/13/2008	11/13/2008	0	UNK	OTH	OTH	Birth control	Drug allergy	The subject reported that she is allergic to sulfa (rash all over the body), LAMISIL and SPORANOX. The subject has previously received flu shots (once, just last year) and has no reactions. Additionally, the subject has received many previous vaccinations with no adverse events.		A0759372A	1						1	Pruritus; Rash; Rash erythematous	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0339075	01/30/2009	KS				M	01/07/2009	This case was reported by a healthcare professional and described the occurrence of rash in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 6 November 2008, the subject received a dose of FLULAVAL (unknown). In November 2008, more than 48 hours after vaccination with FLULAVAL, the subject experienced rash. The healthcare professional reported a male subject experienced a rash (not at the injection site) after receiving FLULAVAL. The rash occurred more than 48 hours after receiving the vaccine. The reporting healthcare professional did not believe the rash was related to the FLULAVAL vaccination. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was not related to vaccination with FLULAVAL. The healthcare professional reported five other subjects adverse events with FLULAVAL. See cases, A0759344A, A0759347A - A0759349A, A0759351A. Follow-up information received on 06 January 2009 provided no additional information concerning the reported event.									U	11/06/2008			UNK	PVT	PVT		Unknown			A0759350A	1						1	Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA209AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0339076	01/30/2009	KS				M	01/07/2009	This case was reported by a healthcare professional and described the occurrence of rash in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 6 November 2008, the subject received a dose of FLULAVAL (unknown). In November 2008, more than 48 hours after vaccination with FLULAVAL, the subject experienced rash. The healthcare professional reported a male subject experienced a rash (not at the injection site) after receiving FLULAVAL. The rash occurred more than 48 hours after receiving the vaccine. The reporting healthcare professional did not believe the rash was related to the FLULAVAL vaccination. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was not related to vaccination with FLULAVAL. The healthcare professional reported five other subjects adverse events with FLULAVAL. See cases, A0759344A, A0759347A, A0759348A, A0759350A, A0759351A. Follow up information received on 06 January 2009 indicated that about one week after receiving Flulaval the subject developed a rash on his face which was later diagnosed as facial psoriasis. The events resolved and were not considered to be related to Flulaval.									Y	11/06/2008			UNK	PVT	PVT		Unknown			A0759349A	1						1	Psoriasis; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA209AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0339077	01/30/2009	KS				F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of rash in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 6 November 2008, the subject received a dose of FLULAVAL (unknown). In November 2008, more than 48 hours after vaccination with FLULAVAL, the subject experienced rash. The healthcare professional reported a female subject experienced a rash (not at the injection site) after receiving FLULAVAL. The rash occurred more than 48 hours after receiving the vaccine. The reporting healthcare professional did not believe the rash was related to the FLULAVAL vaccination. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was not related to vaccination with FLULAVAL. The healthcare professional reported five other subjects adverse events with FLULAVAL. See cases, A0759344A, A0759347A, A0759349A - A059351A. Follow-up information received on 06 January 2003 indicated that about one week after receiving FLULAVAL the subject developed a rash described as 2 or 1 spots on the arms. The spots were diagnosed as ring worm and resolved an unspecified amount of time later. The events wer not ocnsidered related to treatment with FLULAVAL.									U	11/06/2008			UNK	PVT	PVT		Unknown			A0759348A	1						1	Rash; Tinea infection	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA209AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0339078	01/30/2009	KS	53.0	53		F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of rash in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 6 November 2008, the subject received a dose of FLULAVAL (unknown). In November 2008, more than 48 hours after vaccination with FLULAVAL, the subject experienced rash. The healthcare professional reported a female subject experienced a rash (not at the injection site) after receiving FLULAVAL. The rash occurred more than 48 hours after receiving the vaccine. The reporting healthcare professional did not believe the rash was related to the FLULAVAL vaccination. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was not related to vaccination with FLULAVAL. The healthcare professional reported five other subjects adverse events with FLULAVAL. See cases, A0759344A, A0759348A - A059351A. Follow-up information received on 06 January 2009 indicated that the subject was 53 years of age. She received FLULAVAL in the left deltoid on 06 November 2008 and within 48 hours, on 08 November 2009, developed a rash and hives on her upper chest, neck and ears which lasted about three weeks and received by 29 November 2008. It was reported that the subject has many allergies and take an unspecified antihistamine concurrently. She treated the rash and hives with Benadryl and Claritin and was advised by her physician to stop those treatments and only continue her regular antihistamine. The subject has received previous flu shots with no reactions. In the reporter's opinion, the events were possibly related to treatment with FLULAVAL. Three weeks after the vaccination, the reporting nurse saw the subject. The subject had what looked like an intermittent rash on her upper chest. The nurse reported that the subject's employer informed the reporter that the subject was allergic to everything after this happened.				Y					Y	11/06/2008	11/08/2008	2	UNK	PVT	PVT	Antihistamine	Unknown	The subject has a history of many allergies. She reported that she has received flu shots in the past with no reactions.		A0759347A	1						1	No reaction on previous exposure to drug; Rash; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA209AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0339079	01/30/2009	KS				F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of rash in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 6 November 2008, the subject received a dose of FLULAVAL (unknown). In November 2008, more than 48 hours after vaccination with FLULAVAL, the subject experienced rash. The healthcare professional reported a female subject experienced a rash (not at the injection site) after receiving FLULAVAL. The rash occurred more than 48 hours after receiving the vaccine. The reporting healthcare professional did not believe the rash was related to the FLULAVAL vaccination. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was not related to vaccination with FLULAVAL. The healthcare professional reported five other subjects adverse events with FLULAVAL. See cases, A0759347A - A059351A. Follow-up information received on 08 January 2009 indicated that approximately 9 days after receiving FLULAVAL, the subject developed a rash. She saw her doctor and was diagnosed with a bacterial infection that was reportedly not related to FLURAVAL. The subject has a history of many illnesses. The outcome of the events was not reported.				Y					U	11/06/2008			UNK	PVT	PVT		Unknown	The subject has a history of many unspecified illnesses.		A0759344A	1						1	Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA209AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0339080	01/30/2009	MA				F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of incorrect route of drug administration in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent vaccination included Salmonella typhi Vi capsular polysaccharide vaccine given on an unspecified date. There were no concurrent medications. On 2 November 2008, between 09:00 and 16:00, the subject received a dose of FLULAVAL 0.5 ml, subcutaneously, This was the incorrect route of drug administration. FLULAVAL should have been administered intramuscularly. Within 12 to 24 hours following injection of FLULAVAL, the subject experienced injection site pain, redness and swelling. The subject was seen by a physician who diagnosed her with a secondary infection and treated her with antibiotics and TYLENOL. At the time of reporting, the events were improved. In the reporter's opinion, the events, with the exception of the secondary infection which was not specified, were probably related to treatment with FLULAVAL. The reporter stated that approximately 200 adults were vaccinated with FLULAVAL via deep subcutaneous injection during a flu clinic. Out of these 200 plus subjects, four females reported local reactions of pain, redness and swelling within 12 to 24 hours of vaccination. One of these subjects was seen by the on-site physician who diagnosed it as a secondary infection and treated it with antibiotics and TYLENOL. It was reported that the adverse events were improving, but unknown if they resolved. Linked cases include: A0759176A, A0759183A, A0759188A and A0759189A.									N	11/02/2008	11/02/2008	0	UNK	MIL	MIL	No concurrent medication	Unknown	The subject had no relevant medical history. The subject has previously received flu shots with no known reactions. There was no history of adverse events following previous vaccinations. Linked cases include: A0759176A, A0759183A, A0759188A and A0759189A.		A0759190A	1						1	Incorrect route of drug administration; Infection; Injection site erythema; Injection site pain; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA192AA~UNK~SC~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0339081	01/30/2009	MA				F	01/07/2009	This case was reported by a healthcare professional and described the occurrence of incorrect route of drug administration in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent vaccination included Salmonella typhi Vi capsular polysaccharide vaccine given on an unspecified date. There were no concurrent medications. On 2 November 2008, between 09:00 and 16:00, the subject received a dose of FLULAVAL 0.5 ml, subcutaneously, This was the incorrect route of drug administration. FLULAVAL should have been administered intramuscularly. Within 12 to 24 hours following injection of FLULAVAL, the subject experienced injection site pain, redness and swelling. At the time of reporting, the events were improved. In the reporter's opinion, the events  were probably related to treatment with FLULAVAL. The reporter stated that approximately 200 adults were vaccinated with FLULAVAL via deep subcutaneous injection during a flu clinic. Out of these 200 plus subjects, four females reported local reactions of pain, redness and swelling within 12 to 24 hours of vaccination. One of these subjects was seen by the on-site physician who diagnosed it as a secondary infection and treated it with antibiotics and TYLENOL. It was reported that the adverse events were improving, but unknown if they resolved. Linked cases include: A0759176A, A0759183A, A0759188A and A0759190A.									N	11/02/2008	11/02/2008	0	UNK	MIL	MIL	No concurrent medication	Unknown	The subject had no relevant medical history. The subject has previously received flu shots with no known reactions. There was no history of adverse events following previous vaccinations. Linked cases include: A0759176A, A0759183A, A0759188A and A0759190A.		A0759189A	1						1	Incorrect route of drug administration; Injection site erythema; Injection site pain; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA192AA~UNK~SC~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0338728	02/01/2009		40.0	40		M	02/01/2009	On January 8, 2009, patient recieved intranasal life attunated influenza vaccine.  In about 3 days, he started having flu symptoms including fever, body aches and cough that lasted more than 7 days resulting in loss of work.									Y	01/08/2009	01/11/2009	3		UNK	UNK		None known	none known			1						1	Cough; Influenza; Pain; Pyrexia	FLU3~SANOFI PASTEUR~500567P~1~IN~NS~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0338764	02/02/2009	LA	1.25	1	.2	M	01/23/2009	Pt given 5th PCV7 instead of Hept A vaccine. Hept A vaccine then administered.  MTR notified of event.										01/23/2009	01/23/2009	0		PUB	UNK		None			LA090103	1						1	Wrong drug administered	DTAP~SANOFI PASTEUR~U2356CA~4~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2792DA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB225BC~1~IM~RL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~C40031~5~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0338770	02/02/2009	VT	51.0	51		M	01/16/2009	Fever, Chills, and cramps, vomiting									Y	01/13/2009	01/13/2009	0		PVT	PVT		Began 5 hour after injcetion	None			1						1	Chills; Muscle spasms; Pyrexia; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89980~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C2865AA~1~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0338790	02/02/2009	OK	54.0	54		F	02/02/2009	Early the next day after receiving injection her deltoid was swollen, hot to touch, knot @ injection site.  The knot went away and the hot feeling.  Swelling remains and has pain that comes & goes from shoulder to her neck.  Arm hurts with movement. Has seen Dr for pain in arm/neck. Last year the same thing happend on the other arm.  She made several visits to the doctor, was seen by bone & joint specialist, had physical therapy and MRI done last year.  No problem was found.  Pain lasted for 11 months.  Still has residual pain sometime with movement.  Last year she did not consider her flu shot as being the problem with her pain, but now it has happened again this year.  She has no known allergies to foods or drugs.				Y					N	10/23/2008	10/24/2008	1		UNK	UNK	insulin	none	diabetic	pain in arm/neck~Influenza (Seasonal) (Fluzone)~3~53.00~In Patient		1						1	Injection site mass; Injection site warmth; Musculoskeletal pain; Neck pain; Oedema peripheral	FLU3~SANOFI PASTEUR~U2811AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0338792	02/02/2009	MA	24.0	24		F	02/02/2009	Severe swelling, cold sweats, vomiting, finger numbness, point tenderness at site of injection, severe fever for 5 days post injection; followed by 10 day antibiotic treatment which required 13 days before swelling and point tenderness were eliminated.				Y					Y	01/08/2009	01/09/2009	1	n/a	PVT	PVT	none	none	Ezcema, Penecillin, Exercise Induced Asthma			1						1	Cold sweat; Hypoaesthesia; Injection site pain; Injection site swelling; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0338801	02/02/2009	OH	48.0	48		M	02/02/2009	7:00 p.m. fever and dizziness. 8:00 p.m. vomiting chills and cough. 12:00 a.m. awoke with body aches which lasted for 72 hours. It felt like an actual live virus infection.									Y	10/11/2008	10/11/2008	0	None	UNK	PVT	None	None	None	None~ ()~NULL~~In Patient		1						1	Chills; Cough; Dizziness; Pain; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~ask pharmacist~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0338808	02/02/2009	WA	11.0	11		M	02/02/2009	1/30/09 - seen in office with redness, swelling 8 x 10cm with soreness to injection site.  2 x 2 cm ecchymotic right arm about inj. site.  Encouraged rest and ice.									Y	01/30/2009	01/30/2009	0		PVT	PUB	None	No	Asthma, (mild persist.)			1						1	Injection site erythema; Injection site haemorrhage; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2833AA~6~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAB25BAA~1~UN~LA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~V2821AA~1~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B030AA~1~UN~RA~TDAP (BOOSTRIX)~1	USA		Influenza
0338811	02/02/2009	OH	47.0	47		F	02/02/2009	Shot 1-27-09 reported 1-30-09 L arm sore, itchy, warm to touch with erythema.  After exam per doctor no cellulitis.  Hx D.M. Tx with Cephalexin 500 mg Tid.  Ice 3-4 x a day.  Benadryl every 6-8 hours for 24 hours.  Call if no better.									Y	01/27/2009	01/29/2009	2		PVT	PVT		None	Drug allergy - Oxycontin			1						1	Erythema; Pain in extremity; Pruritus; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8803902~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C2994BA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0338813	02/02/2009	MI	49.0	49		F	02/02/2009	Flu vaccine received on 1/30/08 here in the office at 430 pm - over the past 3 days pt c/o R arm swelling at site with redness 2-4 cm non-puritic bump.  Not allergic to eggs, has received flu imm before.  Tx Benadryl/50mg every 6-8 hours.  Contact us if no improvement.									N	01/30/2009	01/31/2009	1	None	PVT	PVT	Pneumococcal vaccine	None	None			1						1	Injection site erythema; Injection site mass; Injection site swelling	FLU3~SANOFI PASTEUR~U27411AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~144X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0338814	02/02/2009	LA	37.0	37		F	02/02/2009	Pain upon injection, in 24 hours, hot, red, swelling.  These symptoms dissipated, then pain into arm to wrist and under arm.  TX: arm sling, cortisone P.O.									N	01/15/2009	01/15/2009	0	None	PVT	PVT	None	None	None			1						1	Arthralgia; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pain in extremity; Swelling	FLU3~SANOFI PASTEUR~U2806AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0338815	02/02/2009	OH	30.0	30		F	02/02/2009	Onset pain in upper outer arm where vaccine administered.  Persisting from time of injection, on/off to 1/13/09 was seen - note worse again.  Hurts to palpule deltoid muscle, use deltoid muscle.										12/09/2008	12/09/2008	0	Evaluated by orthopedist to get physical therapy.	OTH	PVT		URI	Alopecia			1						1	Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~04349111A~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0338820	02/02/2009	NH	45.0	45		M	01/29/2009	Bell's Palsy									N	10/04/2008	01/04/2009	92	All neg - c/w Bell's	OTH	UNK		Cold	High chol; MI			1						1	Facial palsy; Laboratory test normal	FLU3~SANOFI PASTEUR~U2811AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0338825	02/02/2009	IN	17.0	17		M	11/04/2008	At  about 6pm he received his two vaccines HAVRIX and FLUZONE. He was well and with his mother. At 4am that night he woke up in extreme pain, headache, myalgias and he was taken to ER. The end diagnosis was presumed Aseptic Meningitis. He never was sick enough upon presentation for LP so no organism was identified.				Y					Y	10/20/2008	10/20/2008	0	See attached	PVT	OTH	FOCALIN XR, 20mg	None	Bipolar disorder			1						1	Headache; Myalgia; Pain; Urine analysis	FLU3~SANOFI PASTEUR~U282AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB206CA~1~IM~RA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0338849	02/03/2009	NM	0.6	0	.6	F	01/29/2009	Information has been received from a registered nurse concerning a 22 week old female patient who on 06-JAN-2009 was orally vaccinated with the third dose of ROTATEQ (lot # 660881/0310X). It was reported that on 06-JAN-2009 the patient developed diarrhea, persistent vomiting, fever and oliguria since receiving her third dose of ROTATEQ. The patient was seen in the local emergency room and was prescribed unspecified anti-diarrhea medication. The patient was then examined in the office on an unspecified date and was prescribed PEDIALYTE. The parents of the patient called the physician's office today to relay that the symptoms have not improved and were referred to the local pediatric urgent care facility. The nurse considered the patient's diarrhea and persisting vomiting, fever and oliguria to be disabling and immediately life-threatening. A lot check has been requested. Additional information has been requested.			Y	Y				Y	N	01/06/2009	01/06/2009	0	Unknown	OTH	OTH	Unknown		Unknown		WAES0901USA03312	1						1	Diarrhoea; Oliguria; Pyrexia; Vomiting; Diarrhoea; No reaction on previous exposure to drug; Pyrexia; Urine output decreased; Vomiting; Diarrhoea; Pyrexia; Urine output decreased; Vomiting	RV5~MERCK & CO. INC.~0310X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B137AA~UNK~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~2|FLU3~SANOFI PASTEUR~UT2786G~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~SANOFI PASTEUR~A0900~UNK~ID~LL~HIB (ACTHIB)~2|PNC~PFIZER\WYETH~C73459~UNK~IM~LL~PNEUMO (PREVNAR)~2|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC121B137AS~3~UN~UN~DTAP + HEPB + IPV (PEDIARIX)~3|HIBV~SANOFI PASTEUR~UI4428A~2~UN~UN~HIB (ACTHIB)~3|PNC~PFIZER\WYETH~C73459~3~IM~UN~PNEUMO (PREVNAR)~3|RV1~GLAXOSMITHKLINE BIOLOGICALS~0310X~UNK~PO~MO~ROTAVIRUS (ROTARIX)~3	USA	Life Threatening,Disabling	Influenza
0338893	02/03/2009	LA	2.0	2	.0	F	02/03/2009	Vaccination was administered 11/5/2008, pt presented to the clinic on 11/14/2008 with a rash to the injection site that was diagnosed by Dr. as a local reaction to the flu injection, with no induration. She was given a 7 day course of oral Bactrim. 12/30/2008, mom reported to Dr. that the injection site of flu immunization still looked the same and she wanted to report it to the company.									Y	11/05/2008	11/07/2008	2	n/a	UNK	UNK	Bactrim once a day	n/a	Vescouretal Reflux, GE reflux, possible milk allergy			1						1	Injection site rash; Local reaction; Blood test normal; Body temperature increased; Chest X-ray normal; Convulsion; Culture throat negative; Culture urine negative; Erythema; Fatigue; Injection site discolouration; Injection site dryness; Injection site erythema; Injection site scar; Injection site urticaria; Streptococcal identification test negative	FLU3~SANOFI PASTEUR~UT2785BA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~UT2785B~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0338901	02/03/2009	MA	20.0	20		F	02/03/2009	48 hours after administration - Fever, Chills, Swelling at Injection site, Aches, Diahreah for 6 days. DR. visit then sent to ER for fluids for dehydration. Weakness and weight loss continues for about 2 weeks after.				Y					Y	11/28/2008	11/30/2008	2		PVT	PVT	none	none	Celiac Disease			1						1	Asthenia; Chills; Dehydration; Diarrhoea; Injection site swelling; Pain; Pyrexia; Weight decreased	FLU3~SANOFI PASTEUR~U2754AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0554U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0338902	02/03/2009	MI	67.0	67		M	02/03/2009	NO ADVERSE EVENTS, SYMPTOMS, OR TREATMENT REQUIRED									Y	01/26/2009				PVT	PVT	MULTIVITAMIN, GLUCOSAMINE, HERBAL PROSTATE SUPPLEMENT	NONE, WAS IN FOR WELL VISIT/HEALTH MAINTENANCE	HTN, BPH			1						1	No adverse event	FLU3~SANOFI PASTEUR~U2786BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~D21052~1~IM~RA~PNEUMO (PREVNAR)~1|TDAP~SANOFI PASTEUR~UF460AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0338906	02/03/2009	MN	14.0	14		M	02/03/2009	father states symptoms started at 10 PM on 2/2/09 he was trembling, and muscle twitching. then about 5:30 AM on 2/3/09 woke up sick, dizzy, got up and walked and fell over, upper and lower extremities twitching lasting about 30 seconds. presneted to clinic around 8:45 AM 2/3/09 feeling weak and tachycardic, Pulse 135-140. Evaluated by Nurse NP who conferred with MD and decided to send to ER for further evaluation.  2/9/09 Received ER medical records of 2/3/2009. FINAL DX: black out & seizure Records reveal patient experienced seizure x approx 30 secs that AM.  Exam WNL.    2/11/09 Received PCP vaccine records & clinic medical records of 2/3/2009. FINAL DX:none provided Records reveal patient experienced trembling, feeling hot & cold all night & then had witness seizure in AM.  Continued to feel anxious & lightheaded on exam with increased heart rate & BP.  Sent to ER for eval.				Y					U	02/02/2009	02/02/2009	0	LABS: CT head WNL.  WBC 10.8(N), neutros 76%(H), lymphs 13%(L).  Alk phos 339(H), total bilirubin 1.5(H), BUN/creat ratio 27(H), creat 0.6(L).	UNK	UNK						1						1	Asthenia; Dizziness; Fall; Heart rate increased; Malaise; Muscle twitching; Tachycardia; Tremor	FLUN3~MEDIMMUNE VACCINES, INC.~500577P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB309AA~UNK~IM~~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2734AA~UNK~IM~~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0338909	02/03/2009	OK	57.0	57		F	02/03/2009	PATIENT REPORTS TINGLING RIGHT ARM WITHIN 5 MINUTES OF ADMINISTRATION OF IMMUNIZATION BY TIME PATIENT GOT HOME WITHIN THE HOUR RIGHT ARM SWOLLEN AND REDNESS FROM FINGERTIPS TO CHEST AND SHOULDER ON THE SIDE WHERE TDAP GIVEN WITH SOME SWELLING AND REDNESS UP INTO FACE AND RIGHT CHEEK PATIENT TOOK IBUPROFEN AND BENADRYL WITH COLD COMPRESS									Y	02/02/2009	02/02/2009	0		PUB	UNK		N/A	UNKNOWN			1						1	Erythema; Oedema peripheral; Paraesthesia; Swelling face	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89994~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C3032AA~UNK~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0338918	02/03/2009	DC	1.22	1	.2	M	01/12/2009	None Stated									U	10/20/2008	10/20/2008	0		PUB	PUB						1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~UT27886A~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB247AA~1~IM~RL~HEP A (HAVRIX)~1|HIBV~SANOFI PASTEUR~UF488AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C65043~4~IM~LL~PNEUMO (PREVNAR)~1|VARZOS~MERCK & CO. INC.~1079U~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0338919	02/03/2009	WI	18.0	18		F	02/03/2009	US Army NG SGT who noticed a single 4mm vesicular lesion on her left forearm one day following receipt of ANTHRAX (AVA#4), influenza, & typhoid vaccines on 12/18/2008.  No other skin lesions or systemic symptoms reported; non-medical derm photos were sent by pt & did not appear bullous or urticarial (reviewed by VHC Medical Director);  by 12/30/2008, pt reported resolution of vesicle, however a single lesion remained, slightly larger in size and pruritic.  Pt sent a f/u derm photo in which there was a single lesion which appeared flat, erythematous, irregular in shape with a well demarcated slightly raised border.  Pt was advised to f/u with PCM a/o derm for diagnosis and treatment.  To date, unknown whether further f/u a/o diagnosis obtained.  Symptoms:  Lesions, Vesicle.				Y					U	12/18/2008	12/19/2008	1	Unknown	UNK	UNK	None known	None known	None known			1						1	Rash erythematous; Rash pruritic; Skin lesion	ANTH~EMERGENT BIOSOLUTIONS~FAV149~UNK~UN~UN~ANTHRAX (BIOTHRAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA350BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|TYP~SANOFI PASTEUR~A04462~UNK~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0338922	02/03/2009	GA	37.0	37		F	01/09/2009	Rash on upper arm flu shot 46 X 44 mm left DTAP 65 X 39 mm right									Y	01/07/2009			None	MIL	MIL		None	Allergic to TETVACYCLINE.			1						1	Injection site rash	DTAP~SANOFI PASTEUR~C299434A~UNK~UN~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U283AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331445	02/04/2009	AL	57.0	57		M		Hives and wheezing 01 hour after Influenza vaccine. 2/5/09-records received for 11/5/08-presented to ER with skin rash. DX: acute allergic reaction to flu shot.				Y					Y	11/05/2008	11/05/2008	0	None	PVT	UNK	Insulin; CARDURA cream; lovastatin	None	Diabetes;  Hypertension;  Hyperlipidemia			1						2	Urticaria; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA187AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~2	USA	Emergency room visit	Influenza
0339015	02/04/2009	WI	2.0	2	.0	M	02/04/2009	Right leg pain, fever, vomiting, perioral- rash, Itching (scalp) > -acetaminophen (rectal) - warm compresses - ZYRTEC				Y					U	02/03/2009	02/03/2009	0	CBC, normal, 2-4-09	PVT	PVT	FLOVENT		Food allergies, apples, peas, milk; mild asthma			1						1	Full blood count normal; Pain in extremity; Pruritus; Pyrexia; Rash; Vomiting	FLU3~SANOFI PASTEUR~UT2783DA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB262AA~2~IM~LL~HEP A (HAVRIX)~1|PPV~MERCK & CO. INC.~1667U~1~IM~LL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0339017	02/04/2009	IL	1.3			F	02/04/2009	Received vaccine 1/23/09.  Febrile seizure 1/30/09				Y					Y	01/23/2009	01/23/2009	0	+ Flu test in ER on 1/30/09	PVT	PUB		Constipation	History anemia			1						1	Febrile convulsion; Influenza serology positive	FLU3~SANOFI PASTEUR~UT2792AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1362X~1~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1399X~1~UN~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0339032	02/04/2009	IA	52.0	52		F	02/04/2009	Patient underwent surgical debridement of necrotizing faciitis at the site of immunizations.  Discharge to home today on oral antibiotics.				Y	Y	7			Y	01/27/2009	01/27/2009	0	Wound and blood cultures - no growth.  Elevated WBC (14.5).	UNK	PUB	omeprazole, albuterol, ASA, alendronate, mirtazapinte, levetiracetam, topiramate, sumatriptan, vardenafil, phenobarbital, lorazepam, doxazosin	none identified	migraine, seizure disorder, anxiety, alcohol/tobacco use, depression			1						1	Blood culture negative; Culture wound negative; Debridement; Injection site necrosis; Necrotising fasciitis; White blood cell count increased; Injection site erythema; Injection site pain; Injection site swelling; Necrotising fasciitis; Pyrexia; Surgery; White blood cell count increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881292P~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1679U~2~IM~RA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~1679U~2~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0339033	02/04/2009	OH	1.25	1	.3	M	02/04/2009	Developed vomitting, diarrhea, and low grade temp withiin 12 hours of vaccine				Y					Y	02/03/2009	02/04/2009	1		PVT	PUB						1						1	Diarrhoea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~ut2797ea~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~ahavb246aa~1~IM~LL~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~18954~1~IM~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0339048	02/04/2009	WA	12.0	12		M	02/04/2009	6 area of redness and swelling in Lt arm.  Had Tdap & flu vaccine in same arm.									Y	01/26/2009	01/26/2009	0		PVT	PUB			NKDA;  Asthma;  Allergic Rhinitis			1						1	Erythema; Oedema peripheral	FLUX~SANOFI PASTEUR~U2809AA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MNQ~SANOFI PASTEUR~42683AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~AC52B030AA~4~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0339049	02/04/2009	CA	1.4	1	.4	M	01/29/2009	Mom reports that patient had sudden onset of episode of stiffness tonic state x 2-3 sec.  Followed by generalized clonic-like seizure activity of about 5 sec. duration, plus eye deviation & general obtundation:  patient was afebrile at the time and siggle episode.				Y					Y	01/27/2009	01/27/2009	0	Pending	UNK	PVT		Anterior epistaxis				1						1	Depressed level of consciousness; Gaze palsy; Grand mal convulsion; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~UT2783GA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1584X~1~IM~LL~HEP A (VAQTA)~1|HIBV~SANOFI PASTEUR~UF533AC~4~IM~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~1080X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0339320	02/04/2009	LA	5.0	5		F	01/30/2009	This case was reported by a healthcare professional and described the occurrence of thigh erythema in a child subject under the age of 6 years and of unspecified gender who was vaccinated with combined KINRIX, GlaxoSmithKline.  Concurrent vaccination included unspecified vaccines given in an unknown deltoid in December 2008 or January 2009.  Concurrent vaccines were given on the same date as KINRIX.  On an unspecified date (either in December 2008 or January 2009) the subject received unspecified dose of KINRIX in an unknown thigh.  In the evening following KINRIX injection, the subject developed thigh erythema (around the injection site), swelling at the injection site and skin warmth at the injection site.  The events worsened the next day and resolved over the next couple of days.  The healthcare professional considered the events were possibly related to vaccination with KINRIX.  These events occurred in three different subjects under the age of 6 years.  The children's parents called to report the events and were told over the phone to treat the redness and swelling with compresses and Tylenol.  The subjects were not seen in the office.  Linked cases include A0762589A and A0762590A.  Follow-up information received on 27 January 2009 indicated that the subject was a 5 year old female.  Intramuscular KINRIX was administered (0.5 ml) on 05 January 2009.  Concurrent vaccines given on the same date included MMR vaccine, VARIVAX vaccine and flu vaccine (manufacturers unspecified).  Events started one day following administration of KINRIX on 06 January 2009 and resolved three days later on 08 January 2009.  In the reporter's opinion, the events were related to treatment with KINRIX.									Y	01/05/2009	01/06/2009	1	UNK	PVT	PVT		Unknown	The subject was reportedly healthy.  Linked cases include A0762589A and A0762590A.		A0762587A	1						1	Injection site erythema; Injection site swelling; Injection site warmth	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B116AB~UNK~IM~UN~DTAP + IPV (KINRIX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~SC~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~~UNK~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0337896	02/05/2009	CA	50.0			F	02/02/2009	Chest pain, hoarse throat 3 hrs after AFLURIA administration. Treated with BENADRYL and SOLUMEDROL and felt better.					Y				Y		10/22/2008		EKG - WNL	UNK	UNK			Prior allergies:  AMPICILLIN			1						2	Chest pain; Dysphonia; Electrocardiogram normal	FLU3~CSL LIMITED~01149111A~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~2	USA	Hospitalisation	Influenza
0339032	02/05/2009	IA	52.0			M	02/04/2009	Information has been received from a pharmacist concerning a 52 year old male smoker with a seizure disorder, migraines, alcohol use, depression, and an allergy to codeine, insect stings, mushrooms, trazodone hydrochloride, fish and penicillin who on 27-JAN-2009 was vaccinated IM with a 0.5 ml second dose of PNEUMOVAX 23 (lot # 659921/1697U) in the right shoulder. Patient's first dose of PNEUMOVAX 23 was given in Oct 2002. Secondary suspect vaccine included influenza virus vaccine (unspecified) given in the right shoulder on 27-JAN-2009. Concomitant medications included list of medications. Subsequently, the patient experienced necrotizing fasciitis, had symptoms of pain, redness, swelling at the injection site, fever, and an elevated white count on the evening of 27-JAN-2009. On 28-JAN-2009 the patient went to emergency room. Blood cultures, lab test were performed. On 30-JAN-2009 the patient had surgery and was hospitalized. IV antibiotics were used. Necrotizing fasciitis was considered to be an other important medical event and immediately life-threatening. As of 30-JAN-2009, the patient was recovering. Additional information has been requested.			Y	Y	Y	0			N	01/27/2009	01/27/2009	0	Unknown	OTH	OTH	Unknown	Convulsion disorder; Smoker; Migraine; Alcohol use; Depression; Allergy to insect sting; Food allergy; Fish allergy; Penicillin allergy; Drug hypersensitivity			WAES0902USA00052	1						2	Blood culture negative; Culture wound negative; Debridement; Injection site necrosis; Necrotising fasciitis; White blood cell count increased; Injection site erythema; Injection site pain; Injection site swelling; Necrotising fasciitis; Pyrexia; Surgery; White blood cell count increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881292P~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1679U~2~IM~RA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~1679U~2~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Life Threatening,Hospitalisation	Influenza
0339070	02/05/2009	FL	35.0			F	01/07/2009	This case was reported by a pharmacist and described the occurrence of injection site redness in a 35-year-old female subject who was vaccinated with FLULAVAL. In November 2008 the subject received a dose of FLULAVAL at 0.5 ml. Shortly after vaccinations with FLULAVAL, the subject experienced injection site redness and chills. At the time of reporting the events were resolved.									Y				UNK	OTH	PVT		Unknown	The subject has previously received flu shots with no reactions. There was no mention of adverse events following previous vaccinations at the time of present vaccination.		A0760407A	1						1	Chills; Injection site erythema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0339085	02/05/2009	WV	2.0	2	.0	M	02/04/2009	Information has been received from a licensed practical nurse (L.P.N.) concerning a 24 month old premature born male (2 month early) with asthma who was vaccinated subcutaneously with a first 0.5 ml dose of VARIVAX at one year old (in approximately November 2007). On 05-DEC-2008 the patient received a second dose of VARIVAX. On the same day, he also received a dose of flu shot (manufacturer unknown). On 06-DEC-2008 the patient developed fever as high as 103 degrees F, wheezing and shortness of breath. He was seen at an urgent care center and was given antibiotics and mini-neb treatments. It was reported that no lab diagnostics studies were performed. The patient was seen in a physician's office since the events had not improved over the weekend. At the time of the report, 08-DEC-2008, the patient had not recovered. Follow-up information received on 02-FEB-2009 from the L.P.N. indicated that the patient was a premature baby born at 31 weeks gestation. On 05-DEC-2008, at 15:30, the patient was vaccinated in the right thigh with a second dose of VARIVAX (Lot #661008/1317X). It was reported that illness at the time of vaccination included reactive airway disease (RAD) and seasonal allergies. In the afternoon of 06-DEC-2008, the patient developed RAD, fever of 103 and vomited once. Respiratory Syncytial Virus (RSV) test was negative. Chest x-ray showed no active disease. The patient was treated with AUGMENTIN, albuterol (via nebulizer), PEDIAPRED and TYLENOL. It was reported that the patient recovered. His last visit was on 12-DEC-2008. The reporter considered the patient's events to be other important medical events. Additional information has been requested.				Y					Y	12/05/2008	12/06/2008	1	chest X-ray, no active disease; body temp, 12/06/08, 103 F; nasopharyngeal RSV, negative	OTH	PUB		Reactive airways disease; Seasonal allergy; Asthma	Premature birth		WAES0812USA01983	1						1	Body temperature increased; Bronchial hyperreactivity; Chest X-ray normal; Condition aggravated; Dyspnoea; Pyrexia; Respiratory syncytial virus test negative; Seasonal allergy; Vomiting; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~1317X~2~SC~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0339093	02/05/2009	CA	17.0	17		F	02/02/2009	When I joined in March of 1987 I was a healthy teenager with records to prove it. Sometime between March and May of 1987 I received several vaccinations administered with a air gun injector. The vaccines were mixed with other vaccines, it was done outside, the guns were not cleaned in between recruits and I was given vaccines that I was allergic to. To make things worse I was given enough vaccines for at least 3 people. The best my VA case worker and I can figure out is that I got sick about 1 month from the date of the physical I got in January or February. I was sick the entire time I was there. I had pneumonia, sinus infections, ear infections, seizures, passing out, falling asleep all the time, migraines, shortness of breath, vertigo, vision problems, and that is just a few of the problems that I had. I have been being treated for an epilepsy, clotting disorder, migraines, asthma, arthritis, hearing loss, vision problems, among things from 1987 to the present. I have been diagnosed with APS, Lupus anticoagulant, sleep apnea, epilepsy, asthma, COPD, PTSD, OCD, arthritis of every kind, hearing loss, hair loss, teeth fall out, immune system is very poor, and I am currently being tested for kidney failure, diabetes, and Hepatitis. I take many pills and supplements daily. I cannot do anything that I used to. I have no social life. I am sterile and cannot have children ever and now I am having night terrors. I am sick and tired of my life revolving around pill times, what I can or cannot eat, I can't go to the movies, etc. because of the noise and the large amount of people. I have not been able to drive since 1999 and I cannot work. A knee injury I got will in boot camp will never heal and I cannot have surgery to repair it because of the blood disorder. I saw this claim at the FDA site and I am hoping that there is something that you can do to help me.  2/18/09 Received medical records. FINAL DX: antiphospholipid antibody syndrome w/(+) lupus anticoagulant. Records reveal patient experienced PE approx 1993; CVA approx 1995; TIAs x2; LLE DVT approx 1997.  Hosp admit of 10/2003 for SOB, chest pressure & diaphosesis.  Heme/onc consult done.			Y		Y			Y	N	03/20/1987	03/20/1987	0	I have a positive blood test from the labs for cytolysis, high rh and sed rates, and a false positive for Hepatitis C. I finally received a diagnosis in 2003, Aps, Lupus anticoagulant, PTSD, OCD, Hepatitis was a false positive, and COPD. LABS: lupus anticoagulant (+)	UNK	UNK	Unknown March 1987 to May 1987		I have never smoked or drank alcohol.  I have never been pregnant.  No health problems prior to March of 1987.  I never have had any accidents or  PMH: PTSD/depression; chronic night sweats; chronic poly-joint pain; 35# weight loss due to abd pain & decreased appetite; seizure disorder due to MVA w/head injury approx 1985; CAD; HTN; hyperlipidemia; hypothyroidism; asthma; kidney stones; pituitary disorder; chronic OM; LBP; bronchitis; TMJ; PTSD; possible IBS; endometriosis s/p ablation; allergic rhinitis; tubal ligation; disabled since 1990.  Family hx breast cancer, ovarian cancer, heart disease.  Allergy: PCN, tetracycline, codeine, erythromycin, contrast dye, morphine.			1						1	Activities of daily living impaired; Allergy to vaccine; Alopecia; Antiphospholipid syndrome; Arthritis; Asthma; Cell death; Chronic obstructive pulmonary disease; Coagulopathy; Convulsion; Deafness; Dyspnoea; Ear infection; Epilepsy; Hepatitis C virus test; Hypersomnia; Immune system disorder; Impaired driving ability; Impaired work ability; Infertility; Loss of consciousness; Migraine; Obsessive-compulsive disorder; Pneumonia; Post-traumatic stress disorder; Red blood cell sedimentation rate increased; Rheumatoid factor increased; Sinusitis; Sleep apnoea syndrome; Sleep terror; Somnolence; Tooth loss; Vertigo; Visual impairment; Antiphospholipid antibodies; Antiphospholipid syndrome; Convulsion; Pain; Pneumonia	UNK~UNKNOWN MANUFACTURER~~UNK~UN~UN~VACCINE NOT SPECIFIED (NO BRAND NAME)~1|ANTH~UNKNOWN MANUFACTURER~~UNK~UN~UN~ANTHRAX (NO BRAND NAME)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEPAB~UNKNOWN MANUFACTURER~~UNK~UN~GM~HEP A + HEP B (NO BRAND NAME)~2|JEVX~UNKNOWN MANUFACTURER~~UNK~PO~MO~JAPANESE ENCEPHALITIS (NO BRAND NAME)~2|MEN~UNKNOWN MANUFACTURER~~UNK~UN~UN~MENINGOCOCCAL (NO BRAND NAME)~2|MMR~UNKNOWN MANUFACTURER~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~2|OPV~UNKNOWN MANUFACTURER~~UNK~PO~MO~POLIO VIRUS, ORAL (NO BRAND NAME)~2|RAB~UNKNOWN MANUFACTURER~~UNK~UN~UN~RABIES (NO BRAND NAME)~2|SMALL~UNKNOWN MANUFACTURER~~UNK~OT~UN~SMALLPOX (NO BRAND NAME)~2|TTOX~UNKNOWN MANUFACTURER~~UNK~UN~UN~TETANUS TOXOID (NO BRAND NAME)~2|TYP~UNKNOWN MANUFACTURER~~UNK~UN~UN~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~2|VARCEL~UNKNOWN MANUFACTURER~~UNK~UN~UN~VARICELLA (NO BRAND NAME)~2|YF~UNKNOWN MANUFACTURER~~UNK~UN~UN~YELLOW FEVER (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0339101	02/05/2009	MD	29.0	28		U	02/05/2009	Pt is allergic to eggs, and vaccine compoents. Severe stomach cramping, vomiting, headache, dizziness which lasted for 2-3 days				Y					Y	10/25/2006	10/25/2006	0		MIL	MIL	none noted	none reported	Eggs Allergy			1						1	Abdominal pain upper; Allergy to vaccine; Dizziness; Headache; Hypersensitivity; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0339105	02/05/2009	MO	8.0	8		F	02/05/2009	Local allergic skin reaction.									U	02/02/2009	02/03/2009	1		PUB	UNK						1						1	Dermatitis allergic; Local reaction	FLU3~SANOFI PASTEUR~U2789CA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB320BA~1~IM~LL~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1536X~2~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0339107	02/05/2009	PA	11.0	11		F	02/05/2009	Parent reports adolescent having hives on hands,knees and feet that began approximately 2-3 days past receiving vaccines on 1/22/09. Also reports fever for one day when hives began. Using topical benadryl cream with no relief. Hives and c/o itching remain. Hives seen by RN in clinic today. Referred to primary physician.									N	01/22/2009	01/24/2009	2	NONE	PUB	PUB	NONE	NONE	NONE PER PARENT	NONE~ ()~NULL~~In Patient		1						1	Pruritus; Pyrexia; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89976~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HPV4~MERCK & CO. INC.~0960F~2~IM~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2670AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B030AA~1~IM~RA~TDAP (BOOSTRIX)~1	USA		Influenza
0339108	02/05/2009	TX	1.58	1	.6	M	02/05/2009	Patient began febrile episode on 1/31 with fever up to 102.4 F lasting 3 days. Patient was taken  to physician and upon examination no signs of  infections noted.  On 2/4 after fever subsided, rash appeared over entire body per parents.  Rash remains on body as of today,2/5/09 with no other symptoms of reactions reported.				Y					U	01/30/2009	01/31/2009	1		PUB	PUB	none known	none	None known			1						1	Pyrexia; Rash generalised	FLU3~SANOFI PASTEUR~UT2792FA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB257AA~2~IM~LA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0339114	02/05/2009	CA	45.0	45		F	02/05/2009	Immediate localized reaction at injection site including erythema, hives, itching.  Given benadryl 25 mg p.o.  and ice to area.  Reaction resolving 25 minutes after.  Phone follow up next day patient reported no symptoms.									Y	01/29/2009	01/29/2009	0		UNK	UNK						1						1	Immediate post-injection reaction; Injection site erythema; Injection site pruritus; Injection site urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA380AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~MERCK & CO. INC.~1350X~1~IM~RA~HEP B (RECOMBIVAX HB)~1|TDAP~SANOFI PASTEUR~UF455AA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0339119	02/05/2009	MA	85.0	85		M	02/05/2009	The above client had within 24 hours: Fatigue, lethargy, loss of appetite and general weakness.									Y	05/02/2008	05/03/2008	1		OTH	PVT	None					1						1	Anorexia; Asthenia; Fatigue; Lethargy; Cerebral haemorrhage; Death; Acute respiratory failure; Aneurysm ruptured; Bradycardia; Cardiac arrest; Cerebral haemorrhage; Computerised tomogram abnormal; Death; Endotracheal intubation; Intracranial aneurysm; Lethargy; Subarachnoid haemorrhage; Unresponsive to stimuli	FLUX~UNKNOWN MANUFACTURER~AFLLA165AA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0614X~1~IM~LA~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~A41705X~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA165AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~2|PPV~MERCK & CO. INC.~0614X~1~IM~LA~PNEUMO (PNEUMOVAX)~2|VARZOS~MERCK & CO. INC.~1705X~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~2|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA165AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~3|PPV~MERCK & CO. INC.~0614X~1~IM~LA~PNEUMO (PNEUMOVAX)~3|VARZOS~MERCK & CO. INC.~1705X~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~3	USA		Influenza
0339124	02/05/2009	HI	1.56	1	.6	F	02/04/2009	Redness, warmth, swelling around site of 2 injections.  Started 2 days after vaccines given.  No fever.  Prescribed oral antibiotics, BENADRYL, MOTRIN.				Y					U	02/02/2009	02/04/2009	2		MIL	MIL	None	None	None			1						1	Injection site erythema; Injection site swelling; Injection site warmth	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B087BA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U52788IA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB330BA~2~IM~RL~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1535X~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0339140	02/05/2009	OR	1.6	1	.6	M	02/05/2009	No adverse reactions known patient was sent a letter by mail. Patient has no working phone number.									U	02/04/2009				PVT	UNK		NONE	Asthma			1						1	Inappropriate schedule of drug administration; No adverse event	FLU3~SANOFI PASTEUR~UT2783DA~3~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~D16280~5~IM~UN~PNEUMO (PREVNAR)~1|TDAP~SANOFI PASTEUR~C2773BA~1~IM~UN~TDAP (ADACEL)~1	USA		Influenza
0336979	02/06/2009	OR	18.0			M	02/04/2009	Initial report received on 28 January 2009 from the patient's parent. An 18-year-old male patient (date of birth not provided) who had no concurrent illnesses, no pre-existing medical conditions, or use of other medications, had received on 29 December 2008 a first dose of MENACTRA (lot number U2656AA, route and site of administration not reported), and a dose of flu vaccine (trade name, manufacturer name, lot number, route and site of administration unknown). Ten days post-vaccination, the patient was driving in the car and could not speak for 30 minutes and his right face and right arm went numb. He was taken to the emergency room for tests. Then 15 days later, the patient experienced severe vomiting and was taken to the emergency room again for further tests. Per the reporter, a Computerized Axial Tomography (CAT) scan, magnetic Resonance Imaging (MRI) test, electrocardiogram (EKG) and laboratory work up were completed (dates not provided). The results were pending at the time of this report. Per the reporter, tingling on the right side continues (tingling onset date not provided). Recovery status of the patient was reported as unknown. Documents held by sender: None.				Y					U	12/29/2008	01/08/2009	10	Computerized Axial Tomography (CAT) scan, magnetic Resonance Imaging (MRI) test, electrocardiogram (EKG) and laboratory work up were completed. The results were pending at the time of this report.	PVT	OTH			The patient had no illnesses, pre-existing medical conditions, or use of other medications at the time of vaccination on 29 December 2008. The patient had no prior vaccinations within four weeks of 29 December 2008; and has not experienced any adverse events with any prior vaccinations.		200900327	1						2	Cerebrovascular accident; Aphasia; Computerised tomogram; Electrocardiogram; Hypoaesthesia; Laboratory test; Nuclear magnetic resonance imaging; Paraesthesia; Vomiting	FLU3~SANOFI PASTEUR~U2745AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2656AA~UNK~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|MNQ~SANOFI PASTEUR~U2656A~1~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~2	USA	Emergency room visit	Influenza
0339118	02/06/2009		30.0	30		M	02/06/2009	Bell's Palsy developed 17 DEC 08. 2/17/09-records received for DOs 12/22/08-Released form hospital after exhaustive investigation into sudden left facial palsy.					Y	6			Y	10/31/2008	12/18/2008	48	2/17/09-records received-Negative tests except for mild hypokalemia.	UNK	UNK						1						1	Facial palsy	FLUN3~MEDIMMUNE VACCINES, INC.~500562P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0339157	02/06/2009	MI	38.0	38		M	02/06/2009	4:30pm found alert but shaking in bed at a group living setting and then vomited.  Evaluated by medical staff there and sent by ambulance to local ER.  Returned to living setting at 6:50pm and resumed normal activities without any further symptoms or restrictions.				Y					Y	02/04/2009	02/04/2009	0	unknown	UNK	PUB	Unknown		history of anxiety and depression, no known allergies			1						1	Tremor; Vomiting	FLU3~SANOFI PASTEUR~U2768AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB140AA~1~IM~RA~HEP A + HEP B (TWINRIX)~1	USA	Emergency room visit	Influenza
0339159	02/06/2009	AZ	1.34	1	.3	F	02/06/2009	Rash at vaccination site and over entire body.									U	01/26/2009	01/26/2009	0	none	UNK	UNK	none	none	none			1						1	Injection site rash; Rash generalised	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B087BA~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2788FA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB320BA~1~IM~LL~HEP A (HAVRIX)~1|HIBV~SANOFI PASTEUR~1185U~3~IM~LL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~1290X~1~IM~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~D05879~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0950X~1~IM~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0339166	02/06/2009	SC	72.0	72		F	02/06/2009	Day after vaccine, left deltoid became red and swollen.  Tender and warm to touch.  Over the next several days signs and symptoms progressively worsened down arm to elbow area.  On 1/14/09, client saw PMD.  Signs and symptoms continued through 1/15/09.  C/O slight itching of arm, denies numbness.  C/O lymph nodes in groin tender.  Dr. prescribed prednisone 5 mg X 4 days, cipro 500 mg bid X 4 days, cool/warm compresses.				Y					U	01/09/2009	01/10/2009	1		UNK	UNK		None reported	None		SC0904	1						1	Erythema; Lymph node pain; Oedema peripheral; Pain in extremity; Pruritus; Skin warm	FLU3~SANOFI PASTEUR~U2840AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~SANOFI PASTEUR~U2017BA~2~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0339198	02/06/2009	VA	37.0	37		F	10/02/2008	The patient is a 38 year old female.  Source of patient information was patient.  Source of patient information was medical records.  Received second FLUMIST vaccine at NMCP 10/3/2007.  First FLUMIST received 12/6/2006 with common URI symptoms reported lasting 2-3 days that resolved spontaneously.  Following receipt of 10/03/2007 FLUMIST, she again experienced some mild URI symptoms (runny nose, body aches) for a few days but was fine for one week.  By 10/11 she felt exhausted, fatigued, tired, had a non-productive cough, congestion, felt warm.  She tried to work but went home feeling ill for next 72 hours.  She slept for 2 days.  On 10/15/07 she went to PCP.  A CXR diagnosed pneumonia and she was started on 2 weeks of antibiotics with resolution of symptoms.  Past medical history reviewed with patient, by questionnaire, problem list reviewed with patient, medication list reviewed, and family history reviewed with patient.  No systemic symptoms.									Y	10/03/2007	10/11/2007	8	CXR:  pneumonia	MIL	MIL	Multivitamins	None	None			1						1	Chest X-ray abnormal; Cough; Fatigue; Feeling hot; Hypersomnia; Malaise; Nasal congestion; Pain; Pneumonia; Rhinorrhoea; Upper respiratory tract infection	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0339203	02/06/2009	WI	0.7	0	.7	M		Developed emesis and cyanosis a few hours after flu vaccine.  Valvar pulmonic stenosis with 50mm gradient.				Y					Y	01/22/2009	01/22/2009	0	None	PVT	PVT		Pulmonic stenosis; a cyanotic	Eczema; Umbilical hernia			1						1	Cyanosis; Pulmonary valve stenosis; Vomiting	FLU3~SANOFI PASTEUR~UT2792EA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0339204	02/06/2009	OH	55.0	55		M	02/06/2009	2-6-09 Client phoned in and report he had a reaction to pneumonia injection given 2-5-09 here @ PCHD.  Instructed client to take BENADRYL OTC and come in to health Dept for nurse to check the arm.  2-6-09 1:15pm Client R increase arm swollen and warm to touch.  R bicep 34.5 cm L bicep 31.0 cm.  Client reports swelling started on deltoid muscle where shot was given.  Then, dropped to bicap.  Advised cold compress and go to ER.				Y					U	02/05/2009	02/05/2009	0		PUB	UNK						1						1	Feeling hot; Immunisation reaction; Oedema peripheral	FLU3~SANOFI PASTEUR~U2849AC~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0554U~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0339205	02/06/2009	GA	13.0	13		M	02/05/2009	Hep A site, fever 104, red, swollen injection site- less than 24 hrs. Patient irritable + crying frequently.  Influenza site:  Normal.				Y					Y	02/03/2009	02/03/2009	0		PVT	PUB						1						1	Crying; Injection site erythema; Injection site swelling; Irritability; Pyrexia	FLU3~SANOFI PASTEUR~U2831AA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB258AA~1~UN~LL~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0339207	02/06/2009	NC	1.5	1	.5	F	02/06/2009	After VARIVAX vaccine, developed varicella 20 days later.									U	01/15/2009	02/05/2009	21		PVT	PUB	None	No	No			1						1	Varicella post vaccine	DTAP~SANOFI PASTEUR~U2470AA~4~UN~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U28A7AA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1012X~1~UN~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0339208	02/06/2009	GA	1.8	1	.8	F	02/05/2009	Febrile seizures, temp 103.2 degrees.				Y					Y	02/02/2009	02/03/2009	1		PVT	PVT		No	Febrile Seizures			1						1	Body temperature increased; Febrile convulsion	FLU3~SANOFI PASTEUR~U2941CA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB320BA~2~IM~LL~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0330998	02/09/2009	TN	56.0	56		F	02/09/2009	Apprx. 4 hours after flu vaccination, I was unable to raise arm; was limp as if paralyzed. By the third day I could raise it only chest level; had sharp pain & tenderness; could not sleep even when lying on opposite arm. Ibuprofen & Aleve not helpful; Dr. prescribed  Celebrex, Hydrocodn (not helpful); was given cortisone shot in hip and Meloxicam which helped for apprx. 2 weeks; pain returned; referred to orthopedic dr.after MRI showed inflammation and small tear in shoulder; received a shot in the shoulder. After three months and 5 dr. visits, I have improved but not completely; still experience some pain at times.  My first time to experience a reaction after many years of flu vaccinations; fearful of future vaccinations. This is the 3rd attempt to report this. Pharmacy faxed report on 11/01/08, & I mailed a copy on 1/09/09.				Y					N	10/24/2008	10/24/2008	0	MRI left shoulder- inflammation and small tear. 12/15/08.  X-ray- 1/6/09	UNK	UNK	Synthroid	None.  No problems with shoulder until vaccination. Reported this to pharmacy on 10/26.	Thyroid			1						2	Hypokinesia; Hypotonia; Inflammation; Injected limb mobility decreased; Insomnia; Nuclear magnetic resonance imaging abnormal; Pain; Tenderness; X-ray	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881136P~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0339232	02/09/2009	VA				U	11/06/2008	Initial information was received on 29 October 2008 from a manufacturer whose initial reporter was a health care professional. A patient experienced Guillain Barre Syndrome after receiving a flu vaccine in 1980. No further information was available. Follow-up information received 02 February 2009 from a health care professional. According to the reporter, the only situation that would fall under adverse event was when [she] called S-P regarding a patient who was late for #2 GARDASIL and what or #3 schedule should be used. No further information was provided. List of Documents held by Sender: None.				Y									Not reported.	UNK	UNK			Not reported.		200803367	1						1	Guillain-Barre syndrome	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0339234	02/09/2009	AZ				F	02/05/2009	Initial information received on 29 January 2009 from a health care professional. A female patient with a history of diabetes, asthma, and an allergy to morphine received the influenza vaccine (manufacturer, lot number, route and site not reported) on an unspecified date. The patient developed facial swelling post vaccination. The onset date for facial swelling was not provided. No further information was provided. The patient's recovery status was not reported. List of Documents held by Sender: none. The reporter of this case is the same as case number 2009-00328.				Y									not reported.	OTH	OTH			Patient has a history of diabetes, asthma, and an allergy to morphine.		200900334	1						1	Swelling face	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0339258	02/09/2009	NM	51.0	51		M	02/02/2009	Body aches, fever (>100 degrees), chills-onset 8 hrs. After administration of FLUZONE. Lasted over night, until next A.M. Took Tylenol po.									Y	10/29/2008	10/29/2008	0		OTH	PVT	ZOCOR qd	None			NM0209001	1						1	Chills; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U2757AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0339263	02/09/2009	MO	1.1	1	.1	F	02/04/2009	Morn after imm. child had fever 101, rash very red and much more prominent than usual.  No vom or diarrhea.  Took to doctors office at 11 AM.  Doctor called and reported reaction was to one of the vaccines.  Benadryl and Tylenol prn.  2/4 called mom to check on child and she is much better.  Still has dry skin and rash as before imm. with derm.  Will make appt.				Y					Y	01/27/2009	01/28/2009	1	None	PUB	PUB	None	Very dry skin and rash.	Had seen derm for skin rash and to see again after 1 year of age.			1						1	Condition aggravated; Pyrexia; Rash erythematous	FLU3~SANOFI PASTEUR~UT27881A~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB262AA~1~IM~LA~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0987X~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~D07543~4~IM~LA~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1155X~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0339272	02/09/2009	MI	53.0	53		F	02/09/2009	Pruritus as soon as injection given then later that day large reddened area looked like a hive about the size of baseball which lasted several days.									Y	11/04/2008	11/04/2008	0	none	PVT	PVT		no	augmentum,bactrim, titanium			1						1	Erythema; Immediate post-injection reaction; Pruritus; Urticaria	FLU3~CSL LIMITED~02649111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0339280	02/09/2009	MT	49.0	49		M	02/09/2009	Pt experienced shoulder girdle pain for 3 days followd by arm weakness and serratus muscle paralysis which has not resolved as of today. Pt had a similar symptoms after influenza shot in 2007 but only involved pain in the shoulder not weakness like this year.									N	11/04/2008	11/24/2008	20	Pt was evaluated by Physician	PVT	PVT	none	none	none	Lerch, Fred~Influenza (Seasonal) (Fluarix)~0~48.00~In Patient		1						1	Asthenia; Musculoskeletal pain; Paralysis; Similar reaction on previous exposure to drug	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA375AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0339281	02/09/2009	MD	62.0	62		F	02/09/2009	12/3/08 pt started with strangled cough and body aches. 12/12/2008 Had severe vomiting and diarrhea- extremely weak and barely could walk-no stool cultures done. Pt prescribed anti-nausea and anti-diarrheal med. 12/17/2008 Pt achy, tired, and cough returned. 12/21-12/22/2008 Couldn't walk up steps describes legs feeling like jelly. 12/23/08 extreme pain in back and all extremities, but pain only at night. 12/24/2008 Burning electrical pain continued but only at pm. 12/26/08 pt to emergency room-no reflexes present in lower extremities. Admitted to ICU. Seen by neurologist and diagnosed with Guillain Barre Syndrome. Pt had lumbar puncture, MRI, nerve conduction tests. Given IVIG for total of 5 days. 2/6/09 Pt still has residual weakness and compacted feeling in hands.  2/11/09 Received hospital medical records of 12/26-12/31/2009. FINAL DX: Guillain Barre syndrome; cervical spinal stenosis Records reveal patient had stomach flu approx 2 wks prior to admit w/N/V/D that resolved after 3 days.  Developed weakness/numbness of limbs, difficulty walking, & pain in her back x 3 days prior to admit.  Neuro consult done.  Areflexia & loss of sensation of legs.  LP done.  Tx w/IVIG x 5 day w/improvement.  D/C to home w/outpatient PT.  2/16/09 Received CSF results.			Y	Y	Y	6			N	10/22/2008	12/03/2008	42	RPR=non-reactive, Lyme disease=negative, CSF studies as well as serum protein electrophoresis unremarkable other than CSF protein of 77 and WBC of 1. CSF cytology was unremarkable. MRI of head showed mild chronic ischemic microangiopathy and possible empty cellar syndrome. MRI of cervical spine showed changes of cervical spondylosis with bulging of disc osteophyte complex at the c3-c4 and c4-c5 and c5- c6 interspace where there is extrinsic pressure of the thecal sac and extrinsic pressure of the spinal cord at the c-4 to c-5 and c5-c6 interspaces where there is spinal stenosis. Spinal cord itself appears normal. ANA is 146 high and SSA 146 is high.  LABS: CT brain WNL.  EMG/NCS abnormal & c/w GBS	UNK	UNK	Synthroid QD, Diovan QD	None	Hypertension, and hypothyroidism, chronic back pain s/p mva  PMH:panic attack			1						1	Antinuclear antibody increased; Areflexia; Asthenia; Back pain; Blood product transfusion; Borrelia burgdorferi serology negative; Burning sensation; CSF cell count normal; CSF protein increased; CSF white blood cell count; Cough; Diarrhoea; Electrophoresis protein; Fatigue; Gait disturbance; Guillain-Barre syndrome; Intensive care; Muscular weakness; Nuclear magnetic resonance imaging abnormal; Pain; Pain in extremity; Paraesthesia; Protein urine present; Syphilis test negative; Vomiting	FLU3~SANOFI PASTEUR~U2832AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0339282	02/09/2009	CA	0.5	0	.5	M	02/09/2009	Diffuse upper and lower extremity swelling and erythema when extemities are warm. Cyanosis of the swollen extremities when they are cool. Also facial swelling. Also, acting very cranky. Possible slight fever, but none now.									U	02/05/2009	02/07/2009	2	None yet.. will obtain in 48 hours if not improved	PVT	PUB	occuflox eye drops	conjunctivitis	none			1						1	Cyanosis; Irritability; Oedema peripheral; Pyrexia; Swelling face	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B087CA~3~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2785BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB647BA~3~IM~LL~HEP B (ENGERIX-B)~1|PNC~PFIZER\WYETH~D01075~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0339297	02/09/2009	NC	2.0	2	.5	F	02/09/2009	Vaccine on 25-09  2-6-09 fever (elevated to 104.7 rectally - ER notes) lethargy > febrile seizure				Y					Y	02/05/2009	02/06/2009	1	CBC, CMP, CT Brain Scan all normal	PVT	PVT		None	History of GE reflux			1						1	Febrile convulsion; Full blood count normal; Laboratory test normal; Lethargy; Pyrexia; Scan brain	DTAP~SANOFI PASTEUR~U247OCA~4~IM~RL~DTAP (TRIPEDIA)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500584P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB330AA~2~IM~RL~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~A11092~3~UN~RL~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0339302	02/09/2009	CA	8.0	8		M	02/06/2009	Chills, lethargic 10 minutes after the infection chills immediately after injection.									U	02/04/2009	02/04/2009	0		PVT	PVT						1						1	Chills; Immediate post-injection reaction; Lethargy	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89623~3~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0339344	02/10/2009		62.0			M	02/09/2009	Weakness										02/04/2009	02/04/2009	0		UNK	UNK						1						1	Asthenia	FLUX~UNKNOWN MANUFACTURER~~1~SC~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0339346	02/10/2009	WA	1.5	1	.5	F	02/04/2009	Mom States child started becoming grouchy. Appetite decreased. Few days later noticed left side of face/jaw swollen. Went to Doctor-who was sure was mumps from vaccine. Has had no fever-swelling now almost gone-states patient feels fine now.				Y					Y	12/30/2008	01/23/2009	24		PVT	UNK			Intermittent			1						1	Decreased appetite; Irritability; Mumps; Swelling face	DTAP~SANOFI PASTEUR~C2957AA~UNK~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2794CA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB258AA~UNK~IM~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1120X~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1331X~UNK~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0339349	02/10/2009	AZ	4.0	4		M	02/09/2009	Patient received KINRIX (DTap and IPV) to left medial thigh and Flu to left lateral thigh 2/6/09. Mother noticed itching, redness and swelling at medial left thigh evening of 2/8/09. No hives/other rash or other sx. Measuring 20.5cmx14cm.									U	02/06/2009	02/08/2009	2		PUB	PUB		None	None			1						1	Injection site erythema; Injection site pruritus; Injection site swelling	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B116AB~UNK~IM~LL~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~U2766AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1144X~UNK~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0339356	02/10/2009	MA	37.0	37		M	02/10/2009	Patient vaccinated on Friday 2/6/2009 at 11:45am and then approx. 12 hours after vaccination at 1:30am, patient had 102.5 temp with chills, sweats, aches and head pressure for approx 8 hours. Treated with Tylenol 1000mg x 2, and 400mg with Motrin x 2.									Y	02/06/2009	02/07/2009	1	daughter diagnosed on Monday Feb. 9th with Influenza A.	PUB	PUB		none known				1						1	Chills; Headache; Hyperhidrosis; Pain; Pyrexia; Sick relative	FLU3~SANOFI PASTEUR~U2828AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0339388	02/10/2009	CA	0.6	0	.6	M		Pt. given shots on Feb 02, 2009 - namely PEDIARIX #3, HIB #3, PREVNAR #3, ROTAVIRUS #3 and FLU #1 - 3 days later with fever, resp. problems - admitted Feb 06, 2009 for RSV (+) bronchiolitis.   2/13/09 MR received for DOS 2/7-10/09 with D/C DX: Acute Bronchiolitis, RSV positive.  Right Otitis Media.  Acute Interstitial R lung Pneumonia. pt presented to ER with 3 day hx of IRI sx of nasal congestion, rhinorrhea, coughing, fussiness, and decreased po intake. (+) low grade fever. PE (+) for tachypnea, harsh breath sounds with rhonchi. R ear infection noted. Tx:  nebs and abx with improvement.					Y	3			Y	02/02/2009	02/06/2009	4	RSV (+).' Labs and Diagnostics:  RSV Ag (+). CBC WNL.  Globulin low at 2.1. Alk Phos 203.  AST 36.  Total protein 6.5. Blood cx (-).	PVT	PUB		Loss of appetite; nausea X 1 day	PMH: viral rash.			1						1	Pyrexia; Respiratory syncytial virus bronchiolitis; Respiratory syncytial virus test positive	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B137AA~3~UN~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF523AA~3~UN~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C83143~3~UN~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0967X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0339396	02/10/2009	LA	1.5	1	.5	F	02/10/2009	5 minutes after receiving DTaP, HIB and Influenza, patient had a febrile seizure.				Y					U	02/10/2009	02/10/2009	0		PUB	PUB	Zyrtec 1 mL daily	URI - no fever	None			1						1	Febrile convulsion; Immediate post-injection reaction	DTAP~SANOFI PASTEUR~C2957AA~4~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2798HA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF575AA~4~IM~LL~HIB (ACTHIB)~1	USA	Emergency room visit	Influenza
0339119	02/11/2009	MA	86.0	86		M		The above client died on Feb 6th. Family called on Feb 10th to report the death. Patient died of a brain hemorrhage. 3/13/09-records received for DOS 2/6/09-presented with 2 day history of lethargy. Upon arrival oriented x2 then had an acute decompensation intubated. An AICA aneurysm ruptured on 2/4/09 or before. Family declined surgical or IR intervention. Bradycardia. No response to voice or sternal rub, no cough or gag reflex. Asystole.  Recently moved to US from India.  3/24/09-DC Summary received for DOS 2/5-2/6/09-DC DX: Subarachnoid hemorrhage.  4/15/09-Cause of death:Subarachnoid hemorrhage. Aneurysm rupture.	Y	02/06/2009							N	02/02/2009	02/03/2009	1	3/13/09-records received-CT scan showed diffuse SAH.	PVT	UNK	None	None	None			1						2	Anorexia; Asthenia; Fatigue; Lethargy; Cerebral haemorrhage; Death; Acute respiratory failure; Aneurysm ruptured; Bradycardia; Cardiac arrest; Cerebral haemorrhage; Computerised tomogram abnormal; Death; Endotracheal intubation; Intracranial aneurysm; Lethargy; Subarachnoid haemorrhage; Unresponsive to stimuli	FLUX~UNKNOWN MANUFACTURER~AFLLA165AA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0614X~1~IM~LA~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~A41705X~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA165AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~2|PPV~MERCK & CO. INC.~0614X~1~IM~LA~PNEUMO (PNEUMOVAX)~2|VARZOS~MERCK & CO. INC.~1705X~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~2|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA165AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~3|PPV~MERCK & CO. INC.~0614X~1~IM~LA~PNEUMO (PNEUMOVAX)~3|VARZOS~MERCK & CO. INC.~1705X~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~3	USA	Results in Death	Influenza
0339429	02/11/2009	CA	4.0	4		M	02/11/2009	6 cm x 6 cm red, warm, swollen area left deltoid.									Y	02/09/2009	02/10/2009	1	none	PUB	PUB				none~ ()~~0.00~In Patient|none~ ()~~0.00~In Sibling		1						1	Injection site erythema; Injection site swelling; Injection site warmth	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC2DB116AB~5~IM~LA~DTAP + IPV (KINRIX)~1|FLUX~UNKNOWN MANUFACTURER~U27~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~1210X~2~SC~RA~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~1328X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0339439	02/11/2009	NE	8.0	8		F	02/02/2009	Swelling greater than 5cm w/ erythema & pain.									Y	01/30/2009	02/01/2009	2	None	PVT	PVT	None	No	No			1						1	Erythema; Pain; Swelling	FLUN3~MEDIMMUNE VACCINES, INC.~500584P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~1402X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0339441	02/11/2009	CA	8.0	8		F	02/10/2009	Patient noticed a 4 in by 3 in area of redness, warmth and tenderness on site where vaccine was administered, 24 hrs after administration.  Unchanged the following morning (2/5/9).  No improvement on 2/6, KEFLEX given for 10 days.  Per mom on 2/6/9.									Y	02/03/2009	02/03/2009	0		PVT	OTH	None	No	Asthma;  Allergic;  Rhinitis			1						1	Injection site erythema; Injection site pain; Injection site warmth	DTAP~SANOFI PASTEUR~C2935AA~5~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2808AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0339448	02/11/2009	GA	10.0	10		F	02/11/2009	4 CM x 4 CM SWOLLEN SPOT ON RIGHT ARM, NOT RED, NOT WARM, MIDLY TENDER				Y					U	02/09/2009	02/10/2009	1		PVT	PVT	NONE	NONE				1						1	Oedema peripheral; Tenderness	FLUN3~MEDIMMUNE VACCINES, INC.~500589P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB329BA~UNK~IM~LA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0339455	02/11/2009	MI	1.83	1	.9	M	02/11/2009	Parent reported increased swelling at injection site and increased redness size of football. She stated that patient's father felt it might be infected, so he started him on Amoxicillin. She reported that after three days the redness and swelling went away. Reaction was in left leg.									Y	01/30/2009	01/31/2009	1		PVT	PVT		Just over stomach flu and cold.				1						1	Injection site erythema; Injection site swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B087CA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2741AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF531AA~3~IM~LL~HIB (ACTHIB)~1	USA		Influenza
0339459	02/11/2009	AZ	4.0	4		F	02/11/2009	HARD TIME BREATHING,NOT FEELING WELL WAS ADMITTED TO HOSPITAL 2/13/09-records received-for DOS 2/4-2/7/09-DC DX: Influenza A bronchiolitis with hypoxia, now resolved. Pneumonia, resolving. Presented with C/O fever up to 103 the previous night, not sleeping well due to coughing, poor appetite, runny nose for several days with congestion, coughing for 2-3 days. PE: expiratory wheezes.				Y	Y	3			U	11/19/2008	02/04/2009	77	487.1 2/13/09-records received-Chest x-ray showed bronchiolitis with superimposed left lower lobe pneumonia. RSV negative, influenza B positive.	UNK	UNK			2/13/09-records received-PMH:Developmental delay. PPS murmur and previously hospitalized for respiratory distress.			1						1	Dyspnoea; Influenza; Malaise	FLU3~SANOFI PASTEUR~U2898DA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0339464	02/11/2009	MI	0.58	0	.6	M	02/11/2009	Initial flu vaccine given 1-6-2009.  Had fever for 48 hours and fussiness after that vaccine.  Had 2nd dose of flu vaccine 2-9-2009.  Within an hour or two developed vomiting, diarrhea and fever which persists through today.  In addition to vaccines below had flu shot 2-9-2009, sanofi, lot U2764AA in left thigh				Y					U	01/06/2009	01/06/2009	0		UNK	UNK		cold symptoms at time of 2nd flu shot	none			1						1	Diarrhoea; Irritability; Pyrexia; Vomiting	DTAPIPVHIB~SANOFI PASTEUR~c3201AA~2~IM~LA~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~U2839AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0726X~2~IM~LL~HEP B (RECOMBIVAX HB)~1|PNC~PFIZER\WYETH~c87310~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0339483	02/11/2009	TX	1.24	1	.2	M	02/10/2009	Fever 102.3 (r) for 2 days morning after vaccinations. Child later diagnosed with Autism, aphasia, developmental coordination disorder.  2/24/09 Developmental assessment received dated 1/12/2009. Pt in for eval of develpmental delays and atypical behaviors.  Pt had a few words prior to 2nd birthday at which time his language and toileting skills regressed. By age 2 most vocab lost. Pt had persistant loose stools with unpleant odor which improved on gluten free diet. Becomes fixated on lights and ceiling fans, tunes parents out and acts like pt cannot hear them. Developmental course c/w Autism.   DX:  Congenital Encephalopathy manifesting as High Functioning Autism with emerging features of Asperger Syndrome. Aphasia manifesting as a moderate pragmatic language d/o. Developmental Coordination d/o manifesting as delayed fine motor and sensory processing skills leading to dysgraphia-d/o of written output.  Symptoms of anxiety.  Patient had fever response up to 102. Obviously the fever recovered, but the father's main concern was a change in his son's development noted at later well checks. He was diagnosed with Autism. I did not report the fever to VARES system because I feel this is a common reaction to vaccines especially now that we have the knowledge that Proqued has more often caused fever than MMR & VAR separately. Dad was upset that we had not reported his fever t the VARES system, so I welcomed him to report it. He is no longer our patient, so I am not aware of								Y	Y	11/13/2006	11/14/2006	1	Speech language assessment	PVT	UNK	None	Healthy temp 99.1 (R)	None. PMH:  none.			1						1	Aphasia; Autism; Developmental coordination disorder; Psychomotor skills impaired; Pyrexia	FLU3~SANOFI PASTEUR~U2174HA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0604F~UNK~IM~LL~HEP A (VAQTA)~1|MMRV~MERCK & CO. INC.~0519F~UNK~SC~LL~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1	USA	Disabling	Influenza
0339500	02/12/2009	GA	8.0	8		M	02/12/2009	vaccine given 02/09/09. on 02/10/09 mother reported swelling and redness at injection site, RN advised mom to alternate cool and warm compresses to site and give diphenhydramine Q 6 hours as needed. mom to monitor site and report if worse on 02/11/09. on 2/11/09 mother reports that swelling and redness circle arm and warm to touch. RN offered mom appts on 2/11/09 and mother declined. Appt set for 2/12/09. Seen in office with irregular borders covering deltoid area of upper L ext measuring 20cm X 18cm at largest area. Advised mother to continue above care she verbalized understanding and is to call if site worsens or no better in 3-5 days.				Y					Y	02/09/2009	02/10/2009	1	referral for allergy testing to determine possible egg allergy	PVT	PVT	Flovent, Singulair and Allegra	sore throat, cough but afebrile	asthma but no none allergy to eggs			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2762AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0339508	02/12/2009	CA	1.5			M	02/12/2009	MOM STATES HAD FULL BODY RASH, NO FEVER.									Y					PVT	PVT	AMOXICILLIN 400MG/5ML 1 TSP BID X10 DAYS STARTED ON 11/24/2008 MOM STATES NO RASH WITH MEDICATION FOR THOSE DAYS 11/24-11/28.	OTTITIS MEDIA		SMALL RASH~Influenza (Seasonal) (Fluzone)~1~0.50~In Patient		1						1	Rash generalised	FLU3~SANOFI PASTEUR~UT2786FA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0339509	02/12/2009	CA	0.5	0	.5	M	02/12/2009	urticarial rash onset 5 days after vaccines ?rotavirus vac.				Y					Y	02/04/2009	02/08/2009	4		PVT	PVT		none	no			1						1	Urticaria	DTAPIPVHIB~SANOFI PASTEUR~C2881AA/C3203AB~3~IM~LL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~UT2783GA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~D16281~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1462X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0339519	02/12/2009	IA	52.0			M	02/13/2009	We received from a health care professional via the Medical Communication the following information on 30 JAN 2009: A 52-year-old male patient was vaccinated with FLUVIRIN, batch-no. 881292P, i.m. into the right upper arm on 27 JAN 2009. Additionally he was vaccinated with PNEUMOVAX in the right upper arm on the same day. On 28 JAN 2009 he was admitted to the hospital with necrotizing fasciitis in the right shoulder. The patient was surgically debrided. Vaccination history: previous vaccination (s) was (were) given, no information about tolerance. On 04 FEB 2009 we received the following information by phone from the reporting physician: The injection was given by a registered nurse and the reaction started approximately 6 to 8 hours after injection. Laboratory result: wound culture, gram stain negative after 48 hours. The patient's status did not recover and he is to be discharged home on oral antibiotics. No change in assessment. Review of manufacturing protocols on 06 FEB 2009 demonstrated that there were no concerns about sterility.					Y				N	01/27/2009	01/28/2009	1		PUB	OTH	No other medications	Unknown			MA20090232	1						1	Debridement; Gram stain negative; Necrotising fasciitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881292P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0339529	02/12/2009	WA	9.0	9		F	02/12/2009	Pt had severe bronchospasm and shortness of breath 40 minutes after vaccine. No EPi needed; Stable Bp and O2 SAT, 911 to ER -discharged home.				Y					Y	02/11/2009	02/11/2009	0	None	PVT	UNK	None	None	H/o exercise induced asthma; Congenital abnl kidney - removed			1						1	Blood pressure normal; Bronchospasm; Dyspnoea; Oxygen saturation normal	FLU3~SANOFI PASTEUR~U2806AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A1109~2~IM~LA~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0339532	02/12/2009	RI	1.9	1	.9	F	02/12/2009	Immediately after administering, Pt developed hives - no other s/s. Doctor ordered BENADRYL and save Rx for BENADRYL									Y	02/10/2009	02/10/2009	0		PUB	PUB		None	Abnormal gait.			1						1	Immediate post-injection reaction; Urticaria	FLU3~SANOFI PASTEUR~UT2787AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1506X~1~IM~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0339536	02/12/2009	NY	15.0	15		M	02/12/2009	Zoster (shingles) developed # days after vaccine administration.				Y					Y	01/29/2009	02/01/2009	3		PUB	PUB	Albuterol MDI as needed	URI symptoms	Asthma, Allergic rhinitis			1						1	Herpes zoster	FLU3~SANOFI PASTEUR~U2839AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB257AA~1~IM~RA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0339537	02/12/2009	MO	3.0	3		M	02/12/2009	Administered FLUMIST with expiration date 2/3/09 on 2/12/09. No apparent adverse event.									U	02/12/2009				PUB	PUB		None	None			1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500577P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0339538	02/12/2009	MO	2.0	2	.2	M	02/12/2009	Administered FLUMIST with expiration date of 2/3/09 on 2/12/09. No apparent adverse event.										02/12/2009				PUB	PUB		None	None			1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500577P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0339566	02/13/2009	NY	1.5	1	.5	M	02/13/2009	1/14/09 pt received vaccines (Dtap, Fluzone). No allegeries or cold systems noted or reported. 1/15/09 - mother states noted bumps under patient's arms and in peri-area. Red rash progressed to hives over entire body and took on purplish hue along with irritability, fever, and increased lip swelling.  Pt was seen 1/19/09 at ED and discharged then called by PMD to take child to Hospital on 1/20/09 where he was hospitalized for 1 day. After discharge, was followed by Dermotologist and awaiting test results which were received by this office 2/12/09.  2/20/09 Derm consult dated 1/22/09 received as f/u for ER visit for 1 wk hx of fever, irritability, tense painful skin and arthralgias. Periorbital edema and lip swelling noted on arrival to ER.  F/u visit with no DX noted. Still with residual blotchy erythema of the legs which is cyclical in nature.   2/27/09 MR received for DOS 1/20-21/2009 with DX:  Serum sickness. Pt presented with widespread erythema, irritability and fever with lip swelling & erythema.  Admitted for w/u for possible Kawasaki's which was r/o.  Severe itching noted. Tx with steroids and antihistamines and d/c for outpt f/u (above).				Y	Y	1			Y	01/14/2009	01/15/2009	1	General Chemistry, Comprehensive Metobolic Profile, CRP, General Hemotology, UA, Viral Culture, Aerobic Culture. Labs:  WBC 16.5.  Platelets 453.  CRP 108.6. Hgb 9.7.  Hct 29. Globulin (L) at 2.1. Blood cx (-).	UNK	UNK	None	None	None. PMH:   none			1						1	Bacterial culture; Haematology test; Irritability; Laboratory test; Lip swelling; Metabolic function test; Pyrexia; Rash erythematous; Rash generalised; Skin discolouration; Urine analysis; Urticaria; Virus culture	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B060AB~UNK~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2799FA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0339579	02/13/2009	NJ	3.0	3		M	02/13/2009	Mother states he started a fever@ 1PM Fri. 1/30/09& by 8PM it was 104 degrees. Dr's office suggested alternating Motrin&Tylenol-it would go down then 4 hrs later up. Sat.1/31/09PM it was 105.8 degrees-went to ER-they got it down in a few hrs. Took him to Dr's office 2/2/09-No other signs of infection-He concludes it is a reaction to Flu shot. Fever continued till Wed.2/4/09. Today has some aches but NO fever.				Y					Y	01/29/2009	01/30/2009	1		UNK	UNK	None	None	None			1						1	Pain; Pyrexia; Vaccination complication	FLU3~SANOFI PASTEUR~U2831AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0339586	02/13/2009	CT	58.0			M	02/13/2009	4 hours after shot - mild malaise developing, 7 hours after shot- fever and severe chills (chills and shaking was worse than the worst malaria attack I ever had; by hour 9 temperature was 103.5F.  By morning fever low 101's, some aches. symptoms diminished during the day and were gone by the following day.									Y	11/26/2008	11/26/2008	0	none	UNK	UNK	none	none	none.  no previous reaction to flu shots			1						1	Chills; Malaise; Pain; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0339620	02/13/2009	CA	1.1	1	.1	F	02/11/2009	Brief 1 minute seizure - tonic clonic associated with fever.  No treatment except TYLENOL, MOTRIN for fever				Y					Y	01/29/2009	02/07/2009	9	Neg - Throat Culture	PVT	PVT	IBUPROFEN	URI-cold	FEBRILE SEIZURE 1/14/09			1						1	Culture throat; Grand mal convulsion; Pyrexia	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC143087BA~2~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT27820A~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF264AA~2~IM~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0812X~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1403X~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0339622	02/13/2009	KY	58.0	58		F	02/05/2009	Pt. returned to office at 4:00 pm- with red spotty rash on facial area.  No c/o itching voiced.  No rash noted on trunk at time of visit.  VS obtained, normal.  No distress, Advised pt to take BENADRYL.									Y	02/05/2009	02/05/2009	0		PVT	PVT	B/P medicine	None known	None known			1						1	Erythema; Rash	FLU3~SANOFI PASTEUR~U2763AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB140AA~2~IM~RA~HEP A + HEP B (TWINRIX)~1|IPV~SANOFI PASTEUR~A1229~1~SC~LA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0339624	02/13/2009	OR	61.0	61		M	02/05/2009	Ringing in ears 1 hour post injection - Return of Bells palsy, also  set off arthritis & joint pain.  Has had flu shot every year with 0 reaction did not see a physician									Y	10/27/2008	10/27/2008	0	West Nile virus testing- Fall 2008 positive test  April/May 2004 actual illness	PUB	PVT			Bells palsy RT West Nile Virus		OR200903	1						1	Arthralgia; Condition aggravated; Facial palsy; No reaction on previous exposure to drug; Tinnitus; Virus serology test positive; West Nile viral infection	FLU3~SANOFI PASTEUR~U2745AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0338893	02/16/2009	LA	2.0	2	.1	F	02/12/2009	Initial report received on 02 February 2009 from a consumer, who is also the patient's parent. A 24-month-old female patient with a medical history of lactose intolerance and urinary reflux, had received a left upper thigh injection of FLUZONE No Preservative 2008-2009, lot number UT2785BA on 02 November 2008 and within 24 hours, she developed welts at the injection site. According to the reporter, the patient still had discoloration and rough skin like scarring the size of a quarter encircling the injection site. Calamine lotion was applied as corrective treatment. The patient had been receiving Bactrim as a concomitant medication at the time of vaccination. The patient was evaluated by a physician and no further treatment was prescribed. Follow-up information received on 02 February 2009, and on 06 February 2009 from the patient's parent. The patient had no concurrent illnesses or sick contacts; and no family history of seizure at the time of the vaccination on 02 November 2008. The patient takes Bactrim everyday for medical history of urinary reflux. The patient had not received any other vaccinations within four weeks of receiving the FLUZONE on 02 November 2008, and has not experienced any adverse events with prior vaccinations. The FLUZONE administered on 02 November 2008 was the second dose the patient had received, not the third dose as previously reported, and was administered intramuscularly in the morning. The following morning (24 hours post vaccination), the patient experienced red raised welts on the left thigh injection site the size of half dollar. The patient was evaluated by her physician (date not provided) and the parents were told to watch the area. One week later, the red raised welts were still there and the patient was prescribed steroid cream that was applied topical twice a day for one week. The steroid cream did not help and it was stopped. Three months later, the site is not as red and welts are not as raised, but are drier. Also, the cheeks on the patient's face and the area at the injection site on the left thigh appear redder when the patient runs. Per the reporter, on 30 November 2008, which was 28 days post-vaccination, the patient complained of being tired and was put down for a nap. At that time, her temperature was 99.0 degrees Fahrenheit. She slept about one hour and woke up and wanted to eat. While she was eating, she had a seizure and was taken to the emergency room where her temperature was 103.0 degrees Fahrenheit. The patient was treated with alternating Tylenol and Motrin. Diagnostic tests included blood work, urine culture, chest x-ray and throat swab for strep. All tests were negative. The patient was released from the emergency room six hours after arriving. She recovered from the seizure, but at the time of this report had not fully recovered from the left thigh symptoms. From this new information, this case was upgraded to serious. Documents held by sender: None.				Y					N	11/02/2008			02/Feb/2009: None reported. From follow-up received on 06 February 2009, diagnostic tests included blood work, urine culture, chest x-ray and throat swab for strep. All tests were negative.	PVT	OTH	BACTRIM		The patient has lactose intolerance and urinary reflux. Concomitant medications included BACTRIM. From new information received on 06 February 2009, the patient had no concurrent illnesses or sick contacts; and no family history of seizure at the time of the vaccination on 02 November 2008. The patient takes BACTRIM every day for the urinary reflux. The patient had not received any other vaccinations within four weeks of receiving the FLUZONE on 02 November 2008, and has not experienced any adverse events with prior vaccinations.		200900382	1						2	Injection site rash; Local reaction; Blood test normal; Body temperature increased; Chest X-ray normal; Convulsion; Culture throat negative; Culture urine negative; Erythema; Fatigue; Injection site discolouration; Injection site dryness; Injection site erythema; Injection site scar; Injection site urticaria; Streptococcal identification test negative	FLU3~SANOFI PASTEUR~UT2785BA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~UT2785B~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0339642	02/16/2009	PA	52.0	52		M	02/09/2009	States after flu injection 9/29/08, pt became feverish, aching all over, nauseated for a few days, also states he developed a huge cold sore on his nose.									U	09/29/2008	09/30/2008	1		UNK	UNK			Migraine, unspecified, without mention of intractable migraine; Other, mixed, or unspecified drug abuse in remission; Tobacco use disorder; Calculus of kidney; Hepatitis C; Hypothyroidism; Anemia			1						1	Nausea; Oral herpes; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA174AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0339653	02/16/2009	AZ	6.0	6		F	02/16/2009	Developed Influenza A									U	10/11/2008	02/15/2009	127	Rapid Influenza Test	PVT	PVT	nonoe	none	spina bifida occulta			1						1	Influenza; Influenza serology	FLU3~SANOFI PASTEUR~42792AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0339654	02/16/2009	LA	48.0	48		M	02/16/2009	Night after vaccine administered patient developed joint pain, insomnia, numbness of certain areas on right side of body (cheek, elbow, thumb, heel), had headache, chilles, some complaint of chest pain.  3/12/09 MR received from PCP.  Pt in 2/3/09 for multiple vax (8 total) prior to travel abroad.  TC from pt 2/5/09 with c/o H/A and generalized aching, joint pain, and sporadic numbness in the L arm and face.  Seen 2/9/09 for numbness on the R side of body, R arm and hand pain, bilateral knee pain, heaviness in the head. chills, night sweats, chest pain and voice alteration. ROS (+) for fatigue, poor appetite, weight loss, nasal congestion, post nasal drip, muscle pain, joint pain and tingling in addition to above. PE (+) for murmur, sensory disturbance over the R cheek and mandible as well as R heel, numbness R elbow, knee effusion.  Impression:  R sided numbness in various locations.  Joint pain, primarily in R hand & knees.  Recent vaccines.  DM.  Bicuspid aortic valve with aortic insufficiency.  Chest pain.  Neurologist consulted suggests ? mild encephalitis.  Suspect r/t YF vaccine. F/U 3/9/09-overall better but still reports elbow pain and voice alteration.				Y					N	02/03/2009	02/03/2009	0	CBC, CMP - ALT=85, glucose=337, MRI ordered. Labs and Diagnostics:  CBC WNL.  blood glucose 337. ALT  85.  MRI brain (+) for sinus disease, otherwise WNL. Echo abnormal. HgbA1C 8.4. ANA (+). ESR 11.	UNK	UNK	Metformin	None	Diabetes mellitis, bicuspid AV&AI, reports 'cold' 1-2 weeks prior to vaccines. PMH:  DM-recently dx.  Migraines. Bicuspid valve AI. NKDA.			1						1	Alanine aminotransferase increased; Arthralgia; Blood glucose increased; Chest pain; Chills; Headache; Hypoaesthesia; Insomnia; Metabolic function test; Nuclear magnetic resonance imaging	FLU3~SANOFI PASTEUR~U2239AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB155AA~2~IM~LA~HEP A + HEP B (TWINRIX)~1|IPV~SANOFI PASTEUR~A0836-2~2~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|MNQ~SANOFI PASTEUR~U2821AA~2~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PPV~MERCK & CO. INC.~0868X~2~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2767AA~2~IM~RA~TDAP (ADACEL)~1|TYP~SANOFI PASTEUR~B0980-2~2~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|YF~SANOFI PASTEUR~UF432AA~2~SC~LA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0339674	02/16/2009	SC	69.0	69		M	02/12/2009	Leg Pain				Y					N	10/08/2008	12/01/2008	54	NCV/EMG; MRI	PVT	PVT			Bronchitis			1						1	Electromyogram; Nerve conduction studies; Nuclear magnetic resonance imaging; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA167AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0339710	02/17/2009	CA	40.0	40		F	02/06/2009	Headache, emesis. 2 ED visits.				Y					Y	01/27/2009	02/04/2009	8		PUB	UNK		No	No			1						1	Headache; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89977~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0340200	02/17/2009	OH	2.0			F	01/23/2009	A non-serious, spontaneous report of administered expired FLUMIST in a 30 month-old female patient was received from a nurse practitioner in the United States. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 11 customers not discarding product fromt he previous season and 21 product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 24-Mar-2009 and incorporated into the narrative lot investigation results.									Y	01/23/2009	01/23/2009	0		PUB	OTH	Unknown		None		MEDI0007813	1						1	Expired drug administered; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~In500570P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0340201	02/17/2009	NJ	3.0	3		F	01/15/2009	A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a 38-month-old female who received FLUMIST. The patient is one of the 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient received the FLUMIST on 06-Jan-2009, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2009. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that the expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.									Y	01/06/2009	01/06/2009	0		PVT	PVT	Concomitant drug (s) Not Reported				MEDI0007801	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0340202	02/17/2009	NJ	4.0	4		M	01/15/2009	A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a four-year-old male who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient received the FLUMIST on 05-Jan-2009, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; however, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case in submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.									Y	01/05/2009	01/05/2009	0		PVT	PVT	Concomitant Drug (s) Not Reported				MEDI0007798	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0340203	02/17/2009	NJ	4.0	4		F	01/15/2009	A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a four-year-old female subsequent to FLUMIST.  The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009.  Neither the patient's medical history nor concomitant medications were reported.  The patient received FLUMIST on 05-Jan-2009 which expired on 30-Dec-2008.  All the expired FLUMIST vaccines were part of the 300 units with same lot # delivered to the pediatric clinic on 21-Oct-2008.  All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines.  The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and on the same day, it was discovered that expired FLUMIST were given to the 16 patients.  There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter; sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 11 customers not discarding product from the previous season and 21 product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 09-Apr-2009; product complaint investigation results.									Y	01/05/2009	01/05/2009	0		PVT	PVT	Concomitant Drug(s) Not Reported				MEDI0007796	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0340204	02/17/2009	KY	2.7			F	01/21/2009	A non-serious spontaneous report of hives has been received from a physician concerning a 32-month-old female, subsequently to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No past medical history nor concomitant medications were reported. The patient received the first FLUMIST dose on 27-Oct-2008 and the second FLUMIST dose on 30-Dec-2008. On 31-Dec-2008, the patient reported to the physicians office because she got hives all over. The patient was given diphenhydramine and sent home from the physicians office. The outcome was not reported.									U	12/30/2008	12/31/2008	1		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007795	1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500589P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0340205	02/17/2009	CA	5.7			M	01/19/2009	A non-serious spontaneous report of administered of expired FLUMIST was received from a  physician concerning a 58-month-old male.  who received FLUMIST. The patient's medical history and concomitant medications were reported. On 06-Jan-2009, the child inadvertently received expired FLUMIST. There was no adverse event associated with this medication error, therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case in submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medicatin errors that occurred shortly after the product expired. Additional information was received on 01-Apr-2009 that no delayed adverse events resulted from this error. Follow-up information was received on 02-Apr-2009: Product Complaint Investigation results.									Y	01/06/2009	01/06/2009	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007788	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500551P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0340206	02/17/2009	TX	2.0			F	01/12/2009	A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a 24-month-old female subsequent to FLUMIST. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, FLUMIST which expired on 26-Dec-2008 was administered to the patient. There was no adverse event associated with this medication error; therefore, treatment and reported/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 year to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 01-Apr-2009 that no delayed adverse events resulted from this error. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	01/12/2009	01/12/2009	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007766	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0340207	02/17/2009	NJ	3.0	3		F	04/10/2009	`A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a 40-month-old female who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient is one of a pair of siblings who received the FLUMIST on 05-Jan-2009, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case in submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event.  Additional information received on 30-Apr-2009 product complaint investigation results.									Y	01/05/2009	01/05/2009	0		PVT	PVT	Concomitant Drug (s) Not Reported				MEDI0007760	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0340208	02/17/2009	NJ	3.0	3		M	04/20/2009	A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a 38-month-old male who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient received the FLUMIST on 31-Dec-2008, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case in submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event.									Y	12/31/2008	12/31/2008	0		PVT	PVT	Concomitant Drug (s) Not Reported				MEDI0007756	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0340209	02/17/2009	NJ	4.0	4		F	04/10/2009	A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a four-year-old male who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient is one of siblings who received the FLUMIST on 31-Dec-2008, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case in submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event. Additional information received on 10-Apr-2009. product complaint investigatin results.									Y	12/31/2008	12/31/2008	0		PVT	PVT	Concomitant Drug (s) Not Reported				MEDI0007755	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0340210	02/17/2009	DC	2.0	2	.0	F	01/13/2009	A non-serious, spontaneous report of administration of expired product was received from a nurse concerning a 24-month-old female patient subsequent to FLUMIST.  There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous seasaon and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow up received 30-Apr-2009L added product complaint investigation results.									Y	12/29/2008	12/29/2008	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0007750	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500548P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0340211	02/17/2009	DC	2.0	2	.4	M	01/13/2009	A non-serious, spontaneous report of administration of expired product was received from a nurse concerning a 28-month-old male patient subsequent to FLUMIST.  There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 21 product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Follow-up received 30-Apr-2009 added product complaint investigation results.   Follow-up received 30-Apr-2009 added product complaint									Y	12/22/2008	12/22/2008	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0007749	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500548P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0340212	02/17/2009	AZ	2.0	2	.0	U	01/07/2009	A non-serious report of six patients received expired FLUMIST was received from a nurse concerning a 24-month-old patient (gender unknown). The patient's medical history included previous dose of FLUMIST. Concomitant medications were not available. On 01-Jan-2009, six patients from a large pediatric office were administered expired FLUMIST (23-Dec-2008). The product was expired by 10 days. There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Follow up received 05/21/2009. Based on the result of the investigation, the root cause for the medication errors were caused by  1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occured shortly after the product expired.									Y	01/01/2009	01/01/2009	0		PUB	PUB	Concomitant Drug (s) Not Reported		Second vaccination with FLUMIST		MEDI0007740	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500550P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0340213	02/17/2009	MO	2.0	2	.6	F	01/09/2009	A non-serious, spontaneous report of administration of expired product, vomiting and diarrhea was received from a nurse in concerning a 33-month-old female subsequent to FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 year to 59 months of age for FLUMIST.  Neither relevant medical history nor concomitant medication has been reported for this patient.  The patient received expired FLUMIST intranasal on 23-Dec-2008 for Flu Vaccination.  The lot of FLUMIST expired 18-Dec-2008.  The patient began vomiting and diarrhea the morning of 06-Jan-2009.  The patient was without fever, was not taken to the emergency room and did not receiver any treatment other than fluids.  The patients sibling experienced similar events of vomiting and diarrhea over the same time period which required a visit to the emergency room, reference case MEDI-0007733.  As of 09-Jan-2009 the events resolved. based on the results of the investigation , the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring durin the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 09-Apr-2009 that included the results of a root cause investigation of the medication error.									Y	10/23/2008	10/23/2008	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0007734	1						1	Diarrhoea; Expired drug administered; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500548P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0340214	02/17/2009	MO	3.8	3		F	01/09/2009	A non-serious, spontaneous report of administration of expired product, dehydrated, elevated white blood cell, vomiting, diarrhea and lethargic was received from a nurse concerning a 46-month-old female subsequently to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received expired FLUMIST, intranasal on 23-Dec-2008 for Flu Vaccination. The lot of FLUMIST expired on 18-Dec-2008. On 06-Jan-2009 the patient began experiencing vomiting and diarrhea the morning of 06-Jan-2009. The patients mother contacted the pediatricians office and stated she was also lethargic and dehydrated although without fever. The nurse instructed the mother to take the patient to the emergency room where blood work was taken which was normal with the exception of elevated WBC. The patient sibling experienced similar events of vomiting and diarrhea on the same day which did not require a visit to the emergency room, reference case MEDI0007734. As of 09-Jan-2009 the events resolved.									Y	12/23/2008	12/23/2008	0		PVT	OTH	Concomitant Drug (s) Not Reported				MEDI0007733	1						1	Dehydration; Diarrhoea; Expired drug administered; Lethargy; Vomiting; White blood cell count increased	FLUN3~MEDIMMUNE VACCINES, INC.~500548P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0340215	02/17/2009	AZ	4.0	4		U	01/07/2009	A non-serious report of six patients received expired FLUMIST was received from a nurse concerning a four-year-old (unknown gender). The patient's' medical history included previous dose of FLUMIST. Concomitant medications were not available. On 01-Jan-2009, six patients from a large pediatric office were administered expired FLUMIST (23-Dec-2008). The product was expired by 10 days. There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. This case is submitted in accordance with MedImmune's post-markings commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	01/01/2009	01/01/2009	0		PUB	PUB	concomitant Drug(s) Not Reported		Second vaccination of FLUMIST		MEDI0007724	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500550P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0340216	02/17/2009	AZ	9.0	9		U	01/08/2009	A spontaneous non-serious report of administration of expired product was received from a certified medical assistant in a physician's concerning a child of unknown age and gender.  On 07-Jan-2009, the patient received FLUMIST which expired on 15-Dec-2008.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.									Y	01/07/2009	01/07/2009	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0007723	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0340217	02/17/2009	AZ	6.0	6		U	01/08/2009	A non-serious spontaneous report of administration of expired product was received from a certified medical assistant in a physician's office concerning a child of unknown age and gender. On 07-Jan-2009, the patient received FLUMIST which expired on 15-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.									Y	01/07/2009	01/07/2009	0		PVT	OTH	Concomitant Drug (s) Not Reported				MEDI0007722	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0340218	02/17/2009	AZ				U	01/08/2009	A  spontaneous non-serious report of administration of expired product was received from a certified medical assistant in a physician's office concerning a child of unknown age and gender. On 07-Jan-2009, the patient received FLUMIST which expired on 15-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during flu season resulting in some medication errors that occurred shortly after teh product expired. Additional information was received on 09-Apr-2009 that included the results of root cause investigation for the medication error.									Y	01/07/2009	01/07/2009	0		PVT	OTH	Concomitant Drug (s) Not Reported				MEDI0007721	1						1	Expired drug administered; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0340219	02/17/2009	NJ	4.0	4		M	01/06/2009	Expired vaccine used Expired drug administered) A non-serious spontaneous report of administration of expired product s received from a registered nurse concerning a four-year-old male who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 21-Dec-2008, three on 02-Jan-2009,  six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient is one of a pair of sibling who received the FLUMIST on 31-Dec-2008, which expired on 30-Dec-2008. All the expired FLUMIST vaccine were part of the 300 units with same lot # delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse events associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marking commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event.									Y	12/31/2008	12/31/2008	0		PVT	PVT	Concomitant Drug(s) Not Reported				MEDI0007711	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0340220	02/17/2009	NJ	2.0	2	.0	F	01/06/2009	A non-serious spontaneous report of administration of expired product was received from a registered nurses concerning a 24-month-old female who received FLUMIST.  The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009.  Neither the patient's medical history nor concomitant medications were reported.  The patient is one of a pair of siblings who received the FLUMIST on 31-Dec-2008, which expired on 30-Dec-2008.  All the expired FLUMIST vaccines were part of the 309 units with same lot # delivered to the pediatric clinic on 21-Oct-2008.  All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccine.  The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on the day that expired FLUMIST were given to the 16 patients.  There was no adverse event associated with the medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event.									Y	12/31/2008	12/31/2008	0		PVT	PVT	Concomitant Drug (s) Not  Reported				MEDI0007710	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500554~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0340221	02/17/2009	OH	4.0	4		M	01/02/2009	A non-serious report of gave patient expired FLUMIST was received from a nurse concerning a four year old male patient. On 30-Dec-2008, the patient received expired FLUMIST (expiration date not reported). There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Follow-up information received on 04-Aug-2009 included Product complaint Investigative results. Based on the results of the investigation, the root cause for the medication errors were caused by 13 customers not in some medications errors that occurred shortly after the product expired.									Y	12/30/2008	12/30/2008	0		PVT	OTH	Concomitant Drug (s) Not Reported				MEDI0007701	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500561P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0333710	02/18/2009	CA	47.0	47		M	01/21/2009	Guillain Barre diagnosed 11/8/08. 02/01/2010 Still recovering from Guillian Barre' syndrome. Still not back to work. Patient has not returned to our facility.					Y	40	Y		U	10/24/2008	11/08/2008	15		OTH	PVT						1						2	Guillain-Barre syndrome	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA207AA~2~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~2	USA	Hospitalisation	Influenza
0339742	02/18/2009	OH	0.8	0	.8	F	01/14/2009	Vomiting that started several hours after receiving her booster flu shot.									U	01/13/2009	01/13/2009	0	None- suspect gastroenteritis (seeing many patients today with vomiting & diarrhea)	PVT	UNK	ZANTAC 15 mg/cc .9 cc tid	None	GERD			1						1	Gastroenteritis; Vomiting	FLU3~SANOFI PASTEUR~UT2792FA~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0339743	02/18/2009	MN	24.0	24		F	12/01/2008	Soreness									U	10/28/2008	10/29/2008	1		UNK	UNK	Oral contraceptives;  Acne topical & oral		Allergies:  ragweed & oak trees			1						1	Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0339745	02/18/2009	MD	29.0	29		F	02/06/2009	Several hours after receiving the vaccine had chills, fever, myalgias, vomiting and headache. Sxs were severe enough that she was admitted to the hospital for 24 hours for hydration. Fever, Nausea w/vomiting, Headache, general  2/25/09 Received medical records of 2/6/2009. FINAL DX: none provided Records reveal patient experienced chills, fevers, myslgias, vomiting, HA within few hours of 2005 flu vaccine.  24 hr admission for rehydration.  Allergy consult done.  Recommended to have previously tolerated Flu-Mist vaccine(2007) in future.					Y	1				05/18/2005	05/18/2005	0	None	UNK	UNK	None	None	None  PMH:latex induced dermatitis.			1						1	Chills; Headache; Myalgia; Nausea; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0339748	02/18/2009	MA	17.0	17		F	01/29/2009	Immunizations given on 1/12/09 at approx. 4:00 PM. Mom called at 10:40 AM 1/13/09 stating 2-3 inch diameter swollen red area on (L) arm. Appt was scheduled for 2:15 PM which was subsequently cancelled/rescheduled for 1/14/09 at 10:00 AM. Pt was dx with cellulitis and put on Keflex 500mg qid x 7 days. On 1/14/09 at 4:00 PM, temp at 102.8 F and redness extending beyond borders - sent to ER. Went to hospital, admitted and given IV Rocephin, Prednisone, Benadryl x 3 days. Released and doing well.  2/20/09 Received hospital medical records of 1/14-1/16/2009. FINAL DX: cellulitis LUE s/p vaccination; & inflammatory response as side effect of vaccination manifested as fever, redness & soreness at site of injection Records reveal patient experienced swelling & redness over LUE, nausea/vomiting, fever & chills.  Tx w/IV antibiotics.  ID consult done.  Improved & d/c to home on continued oral antibiotics & steroid taper.					Y	3			Y	01/12/2009	01/13/2009	1	LABS: LUE US c/w edema.	PVT	PVT		No	Insulin Resistance and Polycystic Ovary Syndrome  PMH: exercised induced asthma			1						1	Pyrexia	FLU3~SANOFI PASTEUR~U2840AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2825AA~UNK~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PPV~MERCK & CO. INC.~0554U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0339750	02/18/2009	IN	0.5	0	.5	F	01/16/2009	24 hrs after shots had episode of vomiting and developed seizure. Hospitalized and started on Phenobarb.  3/9/09 Received hospital medical records of 1/13-1/14/2009. FINAL DX: no d/c summary available,  Neuro consult states new onset seizures. Records revea patient experienced vomiting, lethargy, pale, shaking.  Transported to ER when continued w/vomiting, lethargy & shaking.  Tx w/IVF, LP & IV antibiotics.  Transferred to higher level of care.  Continued to be lethargic in hospital.  Parent had fever & malaise few days prior to pt admit.  Neuro consult done.  Tx w/Pb.  Improved in AM w/hydration & d/c to home on continued Pb w/neuro outpatient f/u.					Y	1			Y	01/12/2009	01/13/2009	1	EEG nl per report  LABS: head CT scan WNL.  CSF: WBC 2, RBC 1, protein 18, glucose 68, gram stain neg.  Blood, urine & CSF c/s.  EEG WNL.  MRI to be done as outpatient.	PVT	PVT	Poly Visol with Fe, MYLICON	None	Benign extra axial fluid collections of childhood. PMH: lacrimal duct stenosis/infection.			1						1	Convulsion; Electroencephalogram normal; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B201AA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT27946A~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF576AB~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~D16284~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1432X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0339755	02/18/2009	GA	11.0	11		F	11/12/2008	Pain & swelling to the right deltoid area.										11/11/2008				PVT	PVT						1						1	Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8788205~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|MNQ~SANOFI PASTEUR~U2824AA~UNK~UN~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0339761	02/18/2009	FL	73.0	73		F	01/29/2009	Dead feeling in lower part of body.				Y	Y	6			Y	10/15/2008	10/22/2008	7		OTH	UNK		None	None			1						1	Sensory loss	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLA175AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation	Influenza
0339765	02/18/2009	IN	40.0	40		M	01/29/2009	Pt suffer very severe local Rxn at site of pneumococcal vaccine. Two days later suffered urinary retention and ARF. Vaccine was listed as one of many possible causes. Other agents reported to MedWatch.   MR received for DOS 12/182008-1/09/2009 with D/C DX: Paroxysmal Atrial Fibrillation with rapid Atrioventricular conduction.  Ventricular Pre-excitation.  Hx of Bacterial endocarditis.  S/P Aortic Valve replacement (2002). Chronic and acute renal failure.  Massive allergic reaction to Pneumovax vaccine.  Pt already in hospital 12/18-19/2008 for Electrocardioversion which pt tolerated well.  Received Flu and Pneumovax prior to d/c. Pt developed substantila allergic reaction resulting in massive swelling of the L upper extremity with concerns for necrotizing fasciitis. Tx-abx.  Developed acute urinary retention and acute renal failure which improved by d/c w/ some residual renal failure. Required hemodialysis.							Y		Y	12/19/2008	12/19/2008	0	attached. Labs:  Hgb 8.9.  Hct 27.8.  BUN 20 by d/c. Creatinine 6.1 down to 1.9.  INR 2.2.	PVT	PVT	Sodium chloride; Diphenhydramine hcl; lorazepam; Midazolam hcl; Morphine sulfate; Ondansetron  hcl; Oxycodone hcl;	Post Cardioversion	PMH:  Wolff-Parkinson-White paroxysmal atrial arrhythmia.  Aortic valve replacement. Anti-coagulation			1						1	Local reaction; Renal failure acute; Urinary retention	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA358BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1441X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0339767	02/18/2009	NJ	3.0	3		F	01/20/2009	Telephone call from parent - reports child c/o pain left arm + shoulder since vaccine on 1/13/2009 to day of call 1/16/09 - Parent reports relief with Tylenol. 1/20/09 - called parent  this am child fully recovered 0 pain.									Y	01/16/2009	01/16/2009	0	None	PUB	PUB	None	None	None			1						1	Musculoskeletal pain; Pain in extremity	FLU3~SANOFI PASTEUR~UT27886A~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB330A~1~IM~LA~HEP A (HAVRIX)~1|HIBV~UNKNOWN MANUFACTURER~UF332AA~2~IM~RA~HIB (NO BRAND NAME)~1	USA		Influenza
0339774	02/18/2009	CO	59.0	59		F	02/03/2009	Hospitalization for numbness, pain, in hands and feet. IVIG, Narotin. 2/20/09-records received for DOS 11/28/08-presented to ED with C/O hands and feet hurt and tingling and numbness of hands and feet. Symptoms began couple of weeks ago when travelling out of country. DX:Bilateral hand and foot pain, etiology undetermined. Mild Hyperglycemia. 2/26/09-records received for DOS 12/4-12/9/08-DC DX: Post-vaccination demyelinating polyradiculoneuropathy. Presented with numbness and pain in extremities. Treated with IVIG. Nausea vomiting.  Follow-up: Continued nerve pain in hands, feet, continued fatigue. Unable to do physical activity at previous level. Plan to retire earlier due to fatigue. Blood pressure high. Doctor hopes I will continue w/ remyelinization of nerve endings. Doesn't know if I will achieve 100%.				Y	Y	5		Y	N	10/31/2008	11/12/2008	12	MRI;  EMG;  Blood tests 2/20/09-records received-EKG normal, CAT scan of head no evidence of intracranial hemorrhage, possible chronic small vessel ischemia. Chest x-ray normal.CBC and CMP WNL. Glucose 128, D-dimer less than 400.  2/26/09-records received-EMG/NCV demonstrated demyelinating polyradiculoneuropathy most likely chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). CPK increased 204.	PUB	PVT		None	Penicillin; Low thyroid; Elevated cholesterol 2/26/09-records received-PMH:low back pain. neck pain. hypothyroidism.			1						1	Blood glucose normal; Blood test; Blood test normal; Computerised tomogram head; Decreased activity; Electrocardiogram normal; Fatigue; Fibrin D dimer normal; Foreign travel; Hypertension; Immunoglobulin therapy; Metabolic function test; Nausea; Neuralgia; Nuclear magnetic resonance imaging; Pain in extremity; Pain in extremity; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA350BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation,Disabling	Influenza
0339779	02/18/2009	CA	68.0	68		F	12/10/2008	Local area enduration, erythema & swelling extending area 10cm diameter.  No treatment rendered.				Y					Y	12/08/2008	12/10/2008	2	None	PVT	PVT	See list		See list			1						1	Erythema; Induration; Local reaction; Swelling; Erythema; Injection site reaction; Oedema peripheral; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA359CA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1124X~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~1124X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0339780	02/18/2009	CT	53.0	53		F	12/01/2008	On 10/24/08 pt. presented to office c/o pain L deltoid w/ radiation of pain to elbow.  Area of erythema measured 1.5x2 cm.  Normal remainder of exam.  Redness + swelling resolved but pain to elbow from mid-deltoid persisted.				Y					Y	10/22/2008	10/24/2008	2	EMG-neg	PUB	PVT		None	No			1						1	Arthralgia; Electromyogram normal; Erythema; Pain in extremity; Swelling	FLU3~SANOFI PASTEUR~U2745AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0339785	02/18/2009	PA	47.0	47		F	01/13/2009	Achy, Chills, Diarrhea, Malaise following day hives day 4									U	01/08/2009	01/09/2009	1		PVT	PVT	INDERAL, PAXIL	Mild sore throat + Postnasal dip	Percocet -> urny. migraines, hyperlipdemia			1						1	Chills; Diarrhoea; Malaise; Pain; Urticaria	FLU3~SANOFI PASTEUR~42749AA6109~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C3030AA1~1~UN~RA~TDAP (ADACEL)~1	USA		Influenza
0339788	02/18/2009	VA	0.8	0	.8	F	01/14/2009	Facial flushing & macular rash on thorax.									Y	01/14/2009	01/14/2009	0		PVT	PVT	None	Thick nasal d/c	None			1						1	Flushing; Rash macular	FLU3~SANOFI PASTEUR~UT2782DA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0339789	02/18/2009	NM	3.0	3		M	01/12/2009	Immunizations given on 1/8/09 at app. 4:30 pm - Call from mom on 1/9/09 @ 3:30 noting redness, soreness, & swelling of L thigh - PA notified mom to give Ibuprofen & monitor site - Mom took to urgent care where they gave Rx CEPHALEXIN 250 mg/5mL x 10 days - Here in office on 1/12/09 - No redness, swelling -noted- Documented allergy to Hepatitis A -				Y					Y	01/08/2009	01/09/2009	1	None	PVT	OTH	None	None	Under birth wt baby - NKDA - Delayed speech			1						1	Allergy to vaccine; Injection site erythema; Injection site pain; Injection site swelling	DTAP~SANOFI PASTEUR~C2957AA~4~~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2791CA~2~~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB260AA~1~~LL~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0339800	02/18/2009	CA	21.0	21		F	01/12/2009	Patient complaints of wheezing at night and fells pressure on the chest and coughing starts about 2 weeks after vaccination but reported to me on 1/12/2009.									U	10/08/2008	12/22/2008	75		OTH	OTH		None	None Disclosed			1						1	Chest discomfort; Cough; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0339806	02/18/2009	NE		0	.0	F	01/15/2009	Pt was given Influenza virus vaccine instead of Hepatitis B on 12-30-08. She was then given Hepatitis B on 01-2-09.									Y	12/30/2008	12/30/2008	0		PUB	OTH		Newborn	None			1						1	Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA356AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0339810	02/18/2009	VA	68.0	68		F	01/15/2009	Started stiff and could not move right arm for 3 days.  Then the soreness moved down arm and wake up in middle of night.  Went to orthopedic specialist and had x-ray to determine if arthritis or infection.				Y					N	11/17/2008	11/18/2008	1	X-ray	OTH	PVT	None	None	Ovarian Cancer-2001 (cured)			1						1	Injected limb mobility decreased; Musculoskeletal stiffness; X-ray	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~878773P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0339818	02/18/2009	CA	5.0	5		F	02/03/2009	Patient brought back in office by guardian 2/2/09 with a c/o (R) BELLS Palsy noted after one day vaccines for 5 y.o. given KINRIX, MMR, Varicella, Influenza vacc.									U	01/30/2009	01/31/2009	1	None	PVT	UNK	None	None	None			1						1	Facial palsy	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B116AB~1~IM~RA~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~U2793EA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0821X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1281X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0339823	02/18/2009	OR	1.6	1	.6	M	02/03/2009	1 d after vaccines - on 1/16/09, low grade temp. suddenly became limp & unresponsive. Vomited & then responsive. 911 brought to ER then he became more like normal & by time in ER fine. Thought febrile Sz, had no h/o tonic-clonic action. Did have fever. Please see ER record 1/16/09; 2/1/09				Y					Y	01/15/2009	01/16/2009	1		PVT	UNK		None	None			1						1	Body temperature increased; Hypotonia; Unresponsive to stimuli; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B173AA~3~~LA~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2783EA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB262BA~1~~LA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0339824	02/18/2009	ND	3.0	3		M	01/22/2009	First influenza vaccine given approx. 3pm 1/21/09. Caregiver noted hives around injection site and torso approx. 6pm. No other sx other than hives noted by caregiver. Treated with APAP only. Hives described to be faded morning of 1/22/09.									Y	01/21/2009	01/21/2009	0		PUB	PUB	None	None	None known			1						1	Injection site urticaria	FLU3~SANOFI PASTEUR~U2839AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0339827	02/18/2009	PA	52.0	52		F	02/02/2009	Left shoulder discomfort reported 11/13/08 Flu vax given 10/30/08 shoulder X-ray 11/24/08; MRI shoulder 12/4/08 Tx: Physical therapy										10/30/2008	11/13/2008	14		PVT	PVT		None				1						1	Musculoskeletal pain; Nuclear magnetic resonance imaging; X-ray limb	FLU3~SANOFI PASTEUR~U2764AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0339834	02/18/2009	FL	1.28	1	.3	M	01/16/2009	fever and rash									Y	01/02/2009	01/12/2009	10	None	PVT	PVT	NONE	fever and rash	NONE			1						1	Pyrexia; Rash	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B065AA~4~IM~UN~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2787CA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1250X~1~SC~LG~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1380X~1~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0339839	02/18/2009	IL	69.0	69		M	02/18/2009	had 5 weeks of peripheral neuropathy - pain and sensitivity to left triceps and left pectoralis area/chest wall. no weakness. saw a neurologist.									Y	10/06/2008	10/08/2008	2	normal tsh, cbc, cmp	PVT	UNK	hctz, lipitor, nexium	gerd, bph, htn. had a minor dog bite to R wrist 2d prior	none other than gerd, bph, htn			1						1	Blood thyroid stimulating hormone; Full blood count normal; Hyperaesthesia; Metabolic function test normal; Myalgia; Neuropathy peripheral	FLU3~SANOFI PASTEUR~u2756aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0339850	02/18/2009	CA	0.92	0	.9	F	02/18/2009	Baby got vaccine, developed fever in night, by next day fever raised to 106 - went to emergency room for tests, antibiotics in case it was an infection and a steroid in case it was croup.				Y					Y	12/18/2008	12/19/2008	1		UNK	UNK						1						1	Pyrexia	FLU3~SANOFI PASTEUR~UT2794GA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0339856	02/18/2009	OR	68.0	68		F	01/16/2009	Received Tdap, influenza and PNEUMOVAX vaccines 01/06/09. Pt called clinic 01/13/09 to report that on 01/07/09, she had experienced onset severe chills - requiring VALIUM to relive after one hour. In addition - reports weakness, inability to ambulate by self without walker X several days. Other sx: Voice hoarseness, blurred vision, increased fatigue and somnolence. By 01/13/09 - Ambulating with walker unassisted. Vision WNL; fatigue ongoing.									Y	01/06/2009	01/07/2009	1		PVT	UNK	Multiple Maintenance Meds		Multiple Sclerosis; Atrial Fibrillation; Hypothyroidism; HTN	Denies~ ()~~0.00~Patient		1						1	Asthenia; Chills; Dysphonia; Fatigue; Gait disturbance; Somnolence; Vision blurred; Walking aid user	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA359AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0981X~5~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C2936AA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0339868	02/18/2009	MI	4.0	4		M	01/12/2009	None stated				Y					Y	01/09/2009	01/09/2009	0		PVT	PUB			vein of Galson anomaly & Chiari malformation Type 1, VP shunt			1						1	Rash erythematous; Urticaria; Vomiting	DTAP~SANOFI PASTEUR~C2951BA~5~UN~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2839AA~4~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB292AA~2~UN~RL~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~A0996~4~UN~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1249X~2~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1384X~2~UN~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0339882	02/18/2009	NJ	12.0	12		M		Received Flu and MENACTRA 10/31/07. By Thanksgiving he had foot droop of left foot. Seen by primary in Feb. '08 for ankle pain. Referred to Orthopedist and Neurologist. He has subsequently developed foot drop in right and is being treated for an acquired neuropathy.  3/3/09  MR received for DOS 7/21-24/2008 with D/C DX:  Inflammatory Neuropathy as well as multiple out pt visits and diagnostic studies. Pt initially presented in 11/2007 with a L foot drop and inability to move his toes resulting in a limping gait. Genetic testing done and negative for CMT.  EMG/NCS c/w axonal neuropathy, repeat with chronic inflammatory neuropathy.  Developed R foot drop in 5/2008. PE 6/1/08 (+) for decreased strength on plantar/dorsiflexion bilaterally and difficulty with gait and stance. DTRs absent in lower extremities. Admitted for IVIG 7/21/08.  Devloped some H/A with tx. D/C for outpt f/u on prednisone.  Later with DX:  CIDP.  Wearing ankle/foot braces to assist with ambulation.  Muscle wasting noted 10/6/08  and hand tremor 12/24/08. Some improvement in strength noted.  8/25/09 CDC's CISA staff has confirmed VAERS 339882 as CIDP.					Y	3		Y		10/30/2007	11/20/2007	21	EMG/NCV: Possible CIDP; Spinal Fluid increased at 58. Labs and Diagnostics:  EMG/NCS abnormal. MRI brain and spine WNL. CSF protein 58. CSF cx (-). Serum IgA (L) at 58. DEXA (+) for osteoporosis and osteopenia.	PVT	PVT		None	None. PMH:  mild cold sx			1						1	Arthralgia; CSF pressure increased; Peroneal nerve palsy; Areflexia; Arthralgia; Asthenia; Axonal neuropathy; Blood immunoglobulin A decreased; Blood product transfusion; Bone densitometry; CSF protein increased; Chronic inflammatory demyelinating polyradiculoneuropathy; Disability; Dysstasia; Electromyogram abnormal; Gait disturbance; Gene mutation identification test negative; Headache; Movement disorder; Muscle atrophy; Nerve conduction studies abnormal; Osteopenia; Osteoporosis; Peroneal nerve palsy; Tremor	FLU3~SANOFI PASTEUR~U2500AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2538AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|FLU3~SANOFI PASTEUR~U2500AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|MNQ~SANOFI PASTEUR~U2531AA~UNK~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2	USA	Hospitalisation,Disabling	Influenza
0339884	02/18/2009	TX	0.34	0	.3	M	01/13/2009	Maternal grandmother described staring spells which lasted 2 weeks after visit.  She states they were just like patient's mother's absence seizures caused by her DTP vaccine that she grew out of  No report to us of these.  Spells until 1-13-09.									Y	11/10/2008	11/10/2008	0	EEG scheduled	PVT	PUB		No	Sl oeformity of thums			1						1	Electroencephalogram; Staring	DTAP~UNKNOWN MANUFACTURER~C2955AA~2~UN~RL~DTAP (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~UT2783GA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~UNKNOWN MANUFACTURER~UF465AB~2~UN~LL~HIB (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~A0490~2~UN~RL~POLIO VIRUS, INACT. (NO BRAND NAME)~1|PNC~PFIZER\WYETH~C40031~2~UN~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1928U~2~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0339897	02/18/2009	NY	8.0	8		M	01/23/2009	Generalized lesions head to toe-not palms or soles. On dorsum of hands and feet though.				Y					Y	01/12/2009	01/17/2009	5	None	OTH	PUB	None	None	None			1						1	Skin lesion	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89976~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARCEL~MERCK & CO. INC.~1189X~2~SC~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0339899	02/18/2009	NY	4.0	4		M	01/23/2009	redness and swelling of right upper arm x 2d, treated w/KEFLEX									Y	01/12/2009	01/13/2009	1		OTH	PUB	None	None	amoxicillin (rash)			1						1	Injection site erythema; Injection site swelling	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B103AC~UNK~UN~LA~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~U2840AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~UNKNOWN MANUFACTURER~1209X~UNK~UN~RA~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~1393X~UNK~UN~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0339900	02/18/2009	SC	0.5	0	.5	F	01/20/2009	PENTECEL given right thigh in am 1/15/07 - Parents came back in due to pt crying non-stop 11:30 2:00, vomiting X 2, not nursing pt calm at times, repeatedly screamed with movement right leg X 3.  No redness, swelling or ecchymosis @ site.  11/6/09 called mom stated leg still sore, little swelling, T-100-using warm & cold compresses & TYLENOL.  Notified mom we would report				Y					U	01/15/2009	01/15/2009	0		PVT	PUB						1						1	Body temperature; Body temperature increased; Crying; Oedema peripheral; Pain in extremity; Screaming; Vomiting	DTAPIPVHIB~SANOFI PASTEUR~C3183AA~3~IM~RL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~UT279EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~D01074~3~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0339911	02/18/2009	MA	22.0	22		F	01/16/2009	R cervical lymph swelling/tenderness with palpation (Jan 15 2009). Hives and itching on neck and extremities 12 Jan 2009. Seen and treated with PREDNISONE.				Y					Y	01/09/2009	01/12/2009	3		MIL	MIL		None	None			1						1	Lymph node pain; Lymphadenopathy; Pruritus; Urticaria	ANTH~EMERGENT BIOSOLUTIONS~FAV149~UNK~IM~RA~ANTHRAX (BIOTHRAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFU192AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|SMALL~EMERGENT BIOSOLUTIONS~VV04003A~UNK~~LA~SMALLPOX (ACAM2000)~1|TYP~SANOFI PASTEUR~B0347~UNK~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0339915	02/18/2009	MO	66.0	66		M	12/05/2008	Pt c/o shock like sensations in his (L) UE that radiate to his hand. At the time of onset, approximately 2 weeks after the injection, the pt said he did not experience any numbness or pain. Coincidentally, he saw a physician re an unrelated matter. The dates of visit (12/5/08) the physician told the pt the sensation would stop.									Y	11/11/2008	11/15/2008	4	None	OTH	PVT	None	None	None			1						1	Pain	FLU3~SANOFI PASTEUR~U2806AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0339918	02/18/2009	PA	9.0	9		F	12/12/2008	2 day history of rash prior to presentation. On exam, 12cm x 15 cm around erythematous rash lat/post. (L) arm warm to touch, multiple bullae laterally -> given prednisone, KEFLEX pt also presented with torticollis 2 weeks later -> given MOTRIN, BENADRYL									Y	12/10/2008	12/11/2008	1		PVT	PVT	PPD	mild wheezing	Allergy-ASA			1						1	Blister; Rash erythematous; Skin warm; Torticollis	FLU3~SANOFI PASTEUR~U2811AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1020U~2~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0339920	02/18/2009	CA	72.0	72		F	12/27/2008	weakness-fell to the ground stomach upset on Dec 6, 2008 and on Dec 7, 2008									Y	12/06/2008	12/07/2008	1		OTH	OTH		None	None			1						1	Asthenia; Fall; Stomach discomfort	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0339928	02/18/2009	KS	28.0	28		M	01/22/2009	Rash on (R) deltoid, fever, swelling at injection site, body aches, chest tightness, headache. Pt seen by PA at Medical Clinic on 1/22/09. Recommended Ibuprofen and Benadryl prn.				Y					Y	01/20/2009	01/20/2009	0	None	PUB	PVT	None	None	PCN allergy			1						1	Chest discomfort; Headache; Injection site swelling; Pain; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U2770AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0866X~3~IM~LA~HEP B (FOREIGN)~1|PPV~MERCK & CO. INC.~0224X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0339932	02/18/2009	NJ	58.0	58		F	01/13/2009	According to pt several hrs after injection, the site became red, raised and warm to touch. Area was the size of a 50c piece. Ice applied to area since 11/20/09 area becomes itchy sporadically. Pt scratches area-scabs over heals and then becomes itchy									N	11/20/2008	11/20/2008	0	None	UNK	UNK	LOTREL; LIPITOR 10 mg po D, diuretic	None	elevated blood pressure, elevated cholesterol	reaction to meds~Vaccine not specified (no brand name)~UN~0.00~In Patient		1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Injection site warmth; Injection site erythema; Injection site pruritus; Injection site scab; Injection site swelling; Injection site warmth; Injection site erythema; Injection site pruritus; Injection site scab; Injection site swelling; Injection site warmth; No reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~U2769AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2769AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~U2769AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA		Influenza
0339935	02/18/2009	NY	49.0	49		F	01/23/2009	Right arm became very painful, unable to lift.									Y	01/08/2009	01/08/2009	0		PVT	PVT		HTN; COPD; Back and hip pain	NKDA; Hypothyroidism; COPD; HTN			1						1	Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~UT2787AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1124X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0339938	02/18/2009	NY	1.1	1	.1	F	01/23/2009	Dev'd rash that spread over body and face swelling 1 d after vaccines, followed by rhinorrhea and cough. On 1/12/09 child was wheezing. Also taking amoxicillin simultaneously.									Y	01/09/2009	01/10/2009	1		OTH	PUB	amoxicillin	otitis media	none incl. no previous wheezing			1						1	Cough; Rash; Rhinorrhoea; Swelling face; Wheezing	FLU3~SANOFI PASTEUR~UT2797EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1379U~1~IM~RL~HEP A (VAQTA)~1|HIBV~SANOFI PASTEUR~UF522AA~UNK~IM~RA~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~1209X~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1393X~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0339944	02/18/2009	NJ	37.0	37		F	01/16/2009	Had flu shot 1/12/09. Also, exposed to many children with URI symptoms 1/12. On 1/13/09, had syncope related to quick changed in position. Also nasal congestion /sneezing /rhinorrhea /chills and aches with T to 100 deg. Also headache										01/12/2009	01/13/2009	1	None	PVT	PVT	None	None	None			1						1	Body temperature increased; Chills; Headache; Nasal congestion; Pain; Rhinorrhoea; Sneezing; Syncope	FLU3~SANOFI PASTEUR~U2782AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0339946	02/18/2009	CA	10.0	10		F	01/29/2009	Chronic Headache (Migraine)									N	11/03/2008				PVT	PVT	FLONASE nasal	None	allergic rhinitis			1						1	Migraine	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88645~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HPV4~MERCK & CO. INC.~0575X~3~UN~LA~HPV (GARDASIL)~1	USA		Influenza
0339955	02/18/2009	SC	16.0	16		F	02/03/2009	Onset severe bilateral knee pain, spreading to proximal lower leg and distal anterior thighs. No benefit from TORADOL 30 mg IM. Excellent relief with oral Prednisone. Exam remarkable for mild effusion in knees bilaterally only				Y					Y	01/17/2009	01/24/2009	7	Normal: BMP, CBC, CK, ESR, Strep screen, ASO Titer; RA; ANA; HS-CRP, LYME; Antibody, Mono Screen, CMP, Throat culture	PVT	PVT	Fluvoxamine maleate; Benzaclin	OCD; Acne	OCD; Acne			1						1	Antibody test normal; Antinuclear antibody; Arthralgia; Blood creatine phosphokinase normal; Borrelia burgdorferi serology negative; C-reactive protein normal; Culture throat negative; Full blood count normal; Herpes simplex serology negative; Joint effusion; Metabolic function test normal; Mononucleosis heterophile test negative; Pain in extremity; Red blood cell sedimentation rate normal; Rheumatoid factor negative; Streptococcal identification test	FLU3~SANOFI PASTEUR~U2848AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0339961	02/18/2009	PA	68.0	68		M	02/07/2009	Sicker than usual, cold or pains after vaccine, got sick with Flu and other symptoms, such as weakness, fatigue, continual coughing, mucus constant in throat, unable to recover for month (I am taking other medications)									Y	10/15/2008	10/30/2008	15		PVT	PVT	PLAVIX; METOPROLOL; ZOCOR; LISINOPRIL	Had Heart attack 9/18/08	Heart attack			1						1	Asthenia; Cough; Fatigue; Increased upper airway secretion; Influenza; Nasopharyngitis; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0339972	02/18/2009	WA	1.1	1	.1	M	02/11/2009	high fever x 3 nights (night only) (highest 104.5) slight rash all over body, not much appetite, no breathing difficulty									Y	01/26/2009	02/02/2009	7		PVT	PUB		Unknown	none known			1						1	Decreased appetite; Pyrexia; Rash generalised	FLU3~SANOFI PASTEUR~UT2794BA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF514AB~3~UN~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~1926N~1~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C68311~UNK~UN~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0339974	02/18/2009	MA	5.0	5		M	02/07/2009	The day after the immunization was administered, the patient developed a 7.5 cm x 5 cm area of cellulitis. He was started on antibiotics (KEFLEX) afebrile. (L) arm									U	02/05/2009	02/06/2009	1	None	PVT	PUB	Hydrochlorothiazide	None	milk/wheat			1						1	Injection site cellulitis	DTAP~SANOFI PASTEUR~U2396BA~5~UN~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2840AA~3~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0842X~2~UN~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0339980	02/18/2009	TX	63.0	63		F	02/09/2009	Patient called 24 hours after immunization, stating injection site the size of a dime & was red & raised. I told patient to take 2 BENADRYL & I would call Monday. Patient called Monday AM to say red spot is now size of her hand. Told patient to see MD that day. Pt saw MD.									U	02/07/2009	02/08/2009	1		OTH	PVT		None	Patient has history of double mastectomy.			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2742AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0339982	02/18/2009	IA	33.0	33		F	02/11/2009	Had Td and influenza vaccine on 2/9/08-started with vomiting, high fever approx. 2 hours after vaccine									Y	02/09/2009	02/09/2009	0	None	PUB	UNK		None	None			1						1	Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2853AB~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TD~MASS. PUB HLTH BIOL LAB~Td200~1~UN~RA~TD ADSORBED (TDVAX)~1	USA		Influenza
0339989	02/18/2009	VA	32.0	32		F	11/03/2007	Sinus & nasal congestion & pressure, headaches, muscle & joint aches, dizziness, nausea & light headedness for 10 days. Took TYLENOL & SUDAFED.									Y	10/13/2007	10/14/2007	1	None	MIL	MIL	ZOLOFT; TRAZODONE	None	Depression/PMDD			1						1	Arthralgia; Dizziness; Headache; Myalgia; Nasal congestion; Nausea; Sinus congestion; Sinus headache	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0339990	02/18/2009	WA	4.0	4		M	02/11/2009	None at this time									U	02/06/2008				PVT	PUB		None	None			1						1	Inappropriate schedule of drug administration; No adverse event	FLU3~SANOFI PASTEUR~U2833AA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~D05879~1~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0339994	02/18/2009	AZ	45.0	45		F	02/10/2009	L Arm pain radiating to the neck. Pt. can barely lift arm.				Y					U	02/09/2009	02/09/2009	0		PVT	OTH	None	None	Diabetes; Hyperlipidemia.			1						1	Injected limb mobility decreased; Neck pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1441X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0339997	02/18/2009	MN	50.0	50		F	02/12/2009	First dizzy, increased blood pressure-racing pulse, nauseous, bronchial spasms, difficulty breathing and speaking- Taken to ER given BENADRYL and anxiety medicine by IV-Prednisone 5 days				Y					Y	12/11/2008	12/11/2008	0	Allergic reaction causing anxiety reaction	PUB	OTH		None	Allergic to yellow dye, antibiotics, sodium phosphate			1						1	Anxiety; Blood pressure increased; Bronchospasm; Dizziness; Dyspnoea; Heart rate increased; Hypersensitivity; Nausea; Speech disorder	FLU3~SANOFI PASTEUR~U2804AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0340030	02/18/2009	AK	44.0	44		F	02/10/2009	Patient stated she has had pain in her left shoulder and in her left lower arm since receiving the flu vaccine 2/5/09. No redness, swelling or induration at injection site.									U	02/05/2009	02/06/2009	1		PUB	PUB	Unknown	None	Unknown			1						1	Musculoskeletal pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2829AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0340057	02/18/2009	WA	1.9	1	.9	F	02/03/2009	R Lat, post thigh with mild erythema, taut with some mild dimpling swelling (med). 3 puncture sites visible in 3-4 cm diameter area.									Y	01/13/2009	01/14/2009	1		OTH	PUB						1						1	Injection site erythema; Injection site induration; Injection site swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~C2999AA~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2782CA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHAVB258AA~1~IM~LL~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB555AA~1~IM~LL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~C97890~5~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0340461	02/18/2009	NE	18.0			F	02/13/2009	Information has been received from a registered nurse concerning her 18 year old daughter who on 27-OCT-2006 was vaccinated with the first dose of GARDASIL vaccine (Lot#653937/0637F). Concomitant vaccination included influenza virus vaccine (unspecified). It was reported that patient experienced arm tingling 1 1/2-2 years after receiving her first dose of GARDASIL vaccine. It was reported that the patient did not receive the second or third doses. The patient had recovered on an unspecified date. The patient sought medical attention. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 2/11/2009. Follow up information was received on 02-FEB-2009 from a registered nurse concerning a female patient with no pertinent medical history and no known drug allergies/drug reactions who was vaccinated with the first dose of GARDASIL vaccine (Lot # 053937/0637F) on 26-OCT-2006 (previously reported as 27-Oct-2006) intramuscularly in her right arm. Concomitant vaccination included a fifth FLUZONE vaccine (previously unspecififed) (Lot # U2257AA) intramuscularly into the left arm. It was reported that on spring/summer 2007 the patient experienced arm tingling and numbness which came and went on and off over 1-2 months. The patient had been painting and excused it was related to strain and pinched nerve. It was reported that the patient was revaccinated a few months later. It was reported that the patient recovered at the end of summer 2007. Additional information is not expected.				Y					Y	10/26/2006	03/01/2007	126	Unknown	OTH	OTH			Unknown		WAES0901USA03498	1						1	Hypoaesthesia; Paraesthesia	FLU3~SANOFI PASTEUR~U2257AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0637F~1~IM~RA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0340603	02/18/2009		13.0			F	02/13/2009	Information has been received from a nurse practitioner concerning a 13 year old female patient who on 15-JAN-2009 was vaccinated intramuscularly with the second dose of GARDASIL vaccine into the upper deltoid. Concomitant therapy included INFLUENZA VIRUS vaccine (unspecified) in the opposite arm. Within a few moments of receiving the second dose of GARDASIL vaccine, the patient fainted. The patient sought unspecified medical attention. Subsequently, the patient recovered. Additional information has been requested.				Y					Y	01/15/2009	01/15/2009	0	Unknown	OTH	OTH			Unknown	No Relevant Data~ ()~~0.00~In Patient	WAES0901USA02463	1						1	Immediate post-injection reaction; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~2~IM~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0340737	02/18/2009	NY	24.0			F	02/13/2009	Information has been received from a 24 year old female patient, for GARDASIL vaccine, a Pregnancy Registry product concerning herself with no pertinent medical history and no known drug allergy who in September 2008, was vaccinated with the second dose of GARDASIL vaccine. Concomitant therapy included INFLUENZA VIRUS vaccine (unspecified). In approximately 06-DEC-2008 (a month ago), the patient was pregnant. LMP was approximately 06-DEC-2008 and estimated delivery date was 12-Sep-2009. The patient also experienced feeling nauseous and headache. Therapy with GARDASIL vaccine was discontinued. No lab diagnostics studies were performed. The patient did not seek medical attention. At the time of reporting, the patient did not recover yet. No further information is available.									N	09/01/2008	12/06/2008	96	None	OTH	OTH		Pregnancy NOS (LMP = 12/6/2008)		No Relevant Data~ ()~~0.00~In Patient	WAES0901USA00375	1						1	Drug exposure during pregnancy; Headache; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~2~UN~UN~HPV (GARDASIL)~1	USA		Influenza
0339932	02/19/2009	NJ	58.0	58		F	01/22/2009	Initial report received on 16 January 2009 from a health professional. A 58 year old female, with a history of hypertension, Hypercholesterolemia and an unspecified reaction to unspecified international travel medications, received an intramuscular left deltoid injection of FLUZONE (lot number U2769AA) on 20 November 2008 at 16:00 several hours after vaccination, at 18:00, injection site became red, raised and warm to touch. The area was the size of a 50 cent piece. Ice was applied to the area. Since 20 November 2008, the area sporadically becomes itchy. The patient scratches the area, it scabs over, heals, and then becomes itchy again. At the time of the report, the patient had not recovered.									N	11/20/2008	11/20/2008	0		UNK	UNK	LIPITOR; LOTRIL		History of hypertension and hypercholesterolemia. Has had an unspecified reaction to unspecified international travel medications. No other vaccinations within the four previous weeks. No illness at time of vaccination.		200900209	1						2	Injection site erythema; Injection site pruritus; Injection site swelling; Injection site warmth; Injection site erythema; Injection site pruritus; Injection site scab; Injection site swelling; Injection site warmth; Injection site erythema; Injection site pruritus; Injection site scab; Injection site swelling; Injection site warmth; No reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~U2769AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2769AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~U2769AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~3	USA		Influenza
0340008	02/19/2009	IL	0.6	0	.6	M	02/06/2009	Vaccine was given 1/30/09-same day Patient developed repetitive Head nodding 3-4 episodes per hour per parents. Observed 1 episode in clinic									N	01/30/2009	01/30/2009	0	None-Awaiting neurology referral	PUB	OTH	Zinc oxide ointment; NYSTATIN ointment	Diaper Dermatitis	None			1						1	Head titubation	FLU3~SANOFI PASTEUR~U2833AA~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0340009	02/19/2009	VA	45.0	45		F	01/30/2009	9 cm x 10 cm erythematous plaque, hot raised, at injection site, mild pruritis. Pt noted began after injection, enlarging qd									U	01/22/2009	01/22/2009	0	None	PVT	PVT	None	None	None			1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Injection site warmth; Skin plaque	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~87949~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~C2865AA~UNK~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0340014	02/19/2009	MA	64.0	64		M	01/23/2009	Pt reported coldness, stiffness, chills, spasticity occurred 4 hrs after vaccine (flu). Episode lasted 5 minutes.									Y	10/08/2008	10/08/2008	0	None	PVT	PVT		None	cimetadine; CECLOR			1						1	Chills; Feeling cold; Muscle spasticity; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U2757AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0340019	02/19/2009	UT	0.6	0	.6	F	01/29/2009	fever, seizure like activity				Y					Y	01/28/2009	01/29/2009	1		PVT	PVT						1						1	Convulsion; Pyrexia	DTAPIPVHIB~SANOFI PASTEUR~C3203AB~1~UN~RL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~U2763AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~U726X~1~UN~RL~HEP B (FOREIGN)~1|PNC~PFIZER\WYETH~C86138~1~UN~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0340022	02/19/2009	OH	1.1	1	.1	M	01/28/2009	patient received vaccines on 1-16-09- Hepatitis A, PREVNAR, influenza, and MMR. On 1-24-09 patient started with symptoms of rash, fever-rash started on face moving downward. (+) Koplik spots.				Y						01/16/2009	01/24/2009	8	None done	PVT	OTH	None	None	None			1						1	Measles; Pyrexia; Rash	FLU3~SANOFI PASTEUR~UT27886A~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB262AA~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0987X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C40033~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0340035	02/19/2009	WA	1.2	1	.2	M	01/19/2009	Shingles- TX: BENADRYL TYLENOL Topical treatment of lesions									N	12/05/2007	01/19/2009	411		PVT	PUB	none	none	none			1						1	Herpes zoster; Skin lesion	FLU3~SANOFI PASTEUR~U2458BA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAAVB181AA~1~IM~LL~HEP A (HAVRIX)~1|HIBV~SANOFI PASTEUR~UF207AB~4~IM~RL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~208732~3~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~04144~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B03702M~4~UN~UN~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1268U~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0340042	02/19/2009	WI	34.0	34		F	01/26/2009	Numbness in right thumb that rapidly spread to both hands and then into feet. Sense of tongue burning followed by a sense of numbness about the face. Stiffness of legs. Mild saddle area paresthesias. Patient was 1st evaluated on 12/23/08 and c/o symptoms x 1-2 weeks. Patient states 1/26/08 symptoms almost and completely resolved.				Y					N	10/23/2008	12/10/2008	48	MRI/MRA; EMG, labs: B12; ANA; ESR; HCG	PVT	PVT	Levothyroxine; ORTHO NOVUM	No	Hx, metastatic papillary cancer of thyroid s/p thyroidectomy			1						1	Angiogram; Antinuclear antibody; Electromyogram; Glossodynia; Hypoaesthesia; Hypoaesthesia facial; Musculoskeletal stiffness; Nuclear magnetic resonance imaging; Paraesthesia; Pregnancy test; Red blood cell sedimentation rate; Vitamin B12	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0340046	02/19/2009	OH	0.4	0	.4	F	02/02/2009	Influenza vaccine given to child less than 6 months of age.									Y	01/30/2009				PVT	PUB						1						1	Inappropriate schedule of drug administration	DTAPIPVHIB~SANOFI PASTEUR~C3229AA~2~IM~LL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~UT2788IA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~D01075~2~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0340047	02/19/2009	NC	74.0	74		F	01/29/2009	Erythematous, tender to palpitation. Anterior aspect of left arm. Plaque about 4cm in diameter.				Y					U	01/28/2009	01/29/2009	1	None	OTH	PVT	FLAX seed;calcium; magnesium; vitamin B complex; Niacin; Omega 3; COENZYME Q10; Aspirin; Hydrochlorothiazide; SYNTHROID	No	No			1						1	Injection site erythema; Injection site pain; Skin plaque	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA184AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1163X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0340076	02/19/2009	WI	49.0	49		F	02/02/2009	2/2/09 TC from client states upper right arm has been hurting since she received the hepatitis A-B vaccine on 1/12/09. She has applied cold and heat, no discoloration noted, no warmth or redness but c/o pain, no decrease in ROM, no numbness reported by client. Still has sore arm.									U	01/12/2009	01/12/2009	0		PUB	PVT			Recovering from fx heel since 4/08			1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2768AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0340078	02/19/2009	OH	2.0	2	.5	F		Patient with swelling, induration, warmth and ,mild erythema of left thigh.									U	01/27/2009	01/28/2009	1		PVT	PUB		No	Allergy to chicken pox vaccine			1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~UT2788FA~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB257AA~2~UN~LL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~D15050~4~UN~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0340100	02/19/2009	PA	1.9	1	.9	M	02/14/2009	Ataxic gait on 12/3/08,  Flu vaccine 11/17. 3/19/09 MR received from PCP which include neuro consults.  Pt seen 11/17/08 for URI sx. Flu vax given. TC from parent 12/5/08 reporting child's balance is off, falling alot x 4 days. No other sx. Seen 12/6/08. PE (+) for clumsy gait, otherwise WNL. To observe. Assessment:  Clumsiness. Seen in neuro consult 12/9 and 12/12/08.  PE (+) for wide-based ataxic gait and increased muscle tone in extremities. DX:  Likely post-infectious cerebellitis. ? oposclonus-myoclonus ataxia syndrome. Improving by 12/30/08 but some intermittent hand tremulousness noted by parent. Final dx:  cerebellar ataxia.				Y					N	11/17/2008	12/03/2008	16	Labs and Diagnostics:  Brain MRI (+) for ventriculomegaly and prior grade II hemorrhage, repeat (-) for brainstem or cerebellar abnormality. Urine VMA and HVA WNL	PVT	PVT		URI	s/p  NEC; 25 week premie. PMH:  25 wk premie.			1						1	Ataxia	FLU3~SANOFI PASTEUR~U2759AA~3~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0340123	02/19/2009	WA	1.83	1	.8	F	02/19/2009	0 reaction-Pt received Fluzone MDV 0.5ml, and should have received Fluzone 0.25ml.										01/29/2009				PVT	PUB						1						1	Incorrect dose administered	DTAP~GLAXOSMITHKLINE BIOLOGICALS~C2957AA~3~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2829AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~D05879~4~IM~RA~PNEUMO (PREVNAR)~1	USA		Influenza
0340125	02/19/2009	WA	2.0	2	.1	F	02/19/2009	0 reaction- Pt received Fluzone MDV 0.5ml instead of 0.25ml.										01/29/2009				PVT	PUB			Eczema			1						1	Incorrect dose administered	FLU3~SANOFI PASTEUR~U2829AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB262BA~2~IM~LL~HEP A (HAVRIX)~1	USA		Influenza
0340133	02/19/2009		68.0	68		F	02/19/2009	We received the following information from a nurse via the agency on 05 FEB 2009: A 68-year-old woman, born on 26 APR 1940, was vaccinated with 0.5 ml FLUVIRIN, batch-no. 87924, i.m, on 10 NOV 2008. On 11 NOV 2008 the patient complained of soreness at injection site. On 12 NOV 2008 severe muscle and bone pain were reported. On 13 NOV 2008 she experienced shortness of breath which worsened and the patient was admitted to the hospital due to pneumonia on 14 NOV 2008. An antibiotic therapy started and she was discharged on 27 NOV 2008. Symptoms were resolved at time of report. Review of manufacturing protocols demonstrated that there were no deviations affecting product. No change in assessment.					Y	13			Y	11/10/2008	11/14/2008	4		OTH	OTH	No other medications	Unknown			MA20090270	1						1	Bone pain; Dyspnoea; Injection site pain; Myalgia; Pneumonia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~87924~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0340138	02/19/2009	IN	17.0	17		M	02/17/2009	Rash on abdomen and spread to back with itching, stinging and pain. Pain constant treated with VALTREX 1g tid x 7 days and NEUROTIN 500mg bid. Herpes Zoster.				Y					U	10/09/2008	02/02/2009	116		OTH	OTH		Healthy				1						1	Herpes zoster; Pain; Pruritus; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89620~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARCEL~MERCK & CO. INC.~9724308~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0340141	02/19/2009	CA	1.1	1	.1	F	02/19/2009	Rash fever all over body 10 days after immunization pt examined 2/9/09 rash resolved									Y	01/26/2009	02/04/2009	9	None	PUB	PUB		None	None			1						1	Pyrexia; Rash generalised	FLU3~SANOFI PASTEUR~VT2785CA~2~IN~NS~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAV9320BA~1~IM~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1079X~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C83143~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1220X~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0340144	02/19/2009	MO	1.1	1	.1	F	02/19/2009	Patient developed #3 1-2 mm papules red on right thigh 1 week after shots									Y	01/29/2009	02/05/2009	7		PVT	PUB	Started 2-17-09 Augmentin 65 600mg/ 5 cc 3.5 cl po BID for 10 days					1						1	Injection site erythema; Injection site papule	FLU3~SANOFI PASTEUR~U2783CA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB262AA~1~UN~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1083X~1~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1318X~1~UN~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0340151	02/19/2009	VA	41.0	41		F	10/28/2008	developed bilateral red eyes, itching, pain similar to 4/29/05 eye infection 2 hours after receiving both IM influenza 10/2005 and FLUMIST 10/2006.  Problems resolved after nights sleep but was present for 12 hours.  Ear pain, Red eyes, Itchy Eye lids.				Y					Y	10/01/2005	10/01/2005	0		OTH	OTH		TYAESON SUPERFICIAL PUNCTATE KERATITIS				1						1	Eye infection; Eye pain; Eye pruritus; Ocular hyperaemia	FLUX~UNKNOWN MANUFACTURER~UN~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0335004	02/20/2009	CA	4.0	4		M	01/16/2009	A serious post-marketed study report of hydronephrosis and ureteric obstruction has been received from a study investigator concerning a four-year old male subject, participating in a post-marketing study. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history included a left sided abdominal mass found on routine physical examination on 08-Jun-2007 which was diagnosed on 18-Jul-2007 as non-existent, non-functioning, fluid filled space left kidney via renal scan. Concomitant medications were not reported. The subject received FLUMIST 0.25 ml per nostril for influenza immunization on 18-Oct-2007. On 05-Nov-2007, the subject was hospitalized for hydronephrosis and ureteric obstructions. Laparoscopic left simple nephrectomy was performed on the same day. Intra-operative findings included giant hydronephrosis of left kidney with normal ureters suggestive of UPC obstruction and greater than 500 ml of cloudy, but not frankly purulent fluid within the kidney. The patient had uncomplicated surgery with stable vital signs post-operatively. He was discharged from the hospital on 07-Nov-2007. On 19-Nov-2007, the patient was seen at follow-up for possible hypertension secondary to non functioning kidney. Examination revealed an asymptomatic patient, BP of 109/70 and normal examination two-weeks post-surgery. The patient's final pathologic diagnosis was hydronephrosis with interstitial chronic inflammation, fibrosis and glomerular sclerosis, and a haphazard arrangement of smooth muscle proliferation seen in renal pelvis consistent with UPU obstruction of left kidney. The adverse events resolved on 19-Nov-2007. The investigator assessed the events of hydronephrosis and ureteric obstruction as not related to FLUMIST. The sponsor assessed the relationship of the events as not related to FLUMIST. Additional information including hospital records was received on 16 Jan 2009 and incorporated in the narrative: patient's demographics, medical history, suspect drug information, laboratory and diagnostic tests results, adverse events information, outcome of the events.					Y				Y	10/18/2007	11/05/2007	18	26-Jun-2007 Ultrasound: Indicated possibility of severe hydronephrosis; ureteropelvic junction obstruction, multicystic dyspalstic kidney, or possibly multilocular cystic nephroma; 18-Jul-2007 renal scan: Non-existent, non-functioning, fluid spaced left kidney and normal right kidney; 05-Sep-2007 Urinalysis: specific gravity 1,010, urine RBC 5-10/HPF, negative glucose, nitrites and protein, moderate blood; 30-Oct-2007 Urine microscopy: WBC 2-5/HPF, RBC 10-25/HPF, squamous cell 0-2, few bacteria; 30-Oct-2007 urinalysis: yellow, turbid, pH 6.5 specific gravity 1.010, negative glucose, nitrites and protein, large blood;30-Oct-2007 Random glucose 77 mg/dL (reference range 60-159); 30-Oct-2007 PT, patient: 10.9 Sec (reference range 9.4-11.5); 30-Oct-2007 PT INR: 1.0 ratio; 06-Nov-2007 CBC differential: Bands 5% (reference range 0-5); Seg Neutrophils 49% (reference range 16-60); Lymphocytes 36% (reference range 20-70); Monocytes 6% (reference range0-7); 06-Nov-2007 Westergreen ESR: 27 mm/Hr (reference range 0-15); 20-Nov-2007: final Pathologic Diagnosis of left kidney: Hydronephrosis with interstitial chronic inflammation, fibrosis and glomerular sclerosis, and a haphazard arrangement of smooth muscle proliferation seen in renal pelvis consistent with UPJ obstruction;APTT, 10/30/07, 30.8 Sec, 23.2 - 32.1; BUN 10/30/07, 19 mg/dL, 9 - 20; Chloride 10/30/07, 102 mEq/L, 98 - NI; Creatinine, 10/30/07, 0.50 mg/dL, 0.30 -0.70; CT scan, 07/02/07, Suspect multicystic dysplastic left kidney; Hematocrit, 10/30/07, 37.2%, 34.0 - 40.0, 11/06/07, 12.1, 34.0 - 40.0; Hemoglobin, 10/30/07, 13 g d/L, 11.5 - 13.5, 11/06/07, 11.1 g/dL, 11.5 - 13.5; Platelet count, 10/30/07, 213 K/uL, 140 -400, 11/06/07, 197 K/uL, 140 -400; Potassium, 10/30/07, 3.9 mEq/L, 3.5 - 5.3; Sodium, 10/30/07, 139 mEq/L, 137 -145; Urinalysis, 06/26/07, Hematuria; Urine Culture, 10/30/07, 10/30/07, No growth at 36 - 48 hours; WBC, 10/30/07, 5.7 K/uL, 5.0 - 15.5, 11/06/07, 5.8 K/uL, 5.0 - 15.5; X-ray, 06/08/07, Probable obstipation or constipation.	OTH	OTH	Concomitant Drug(s) Not Reported		08-Jun-2007: Left sided abdominal mass found on routine physical examination; 18-Jul-2007: Diagnosed with non-existent, non-functioning, fluid filled space left kidney via renal scan; 11-Sep-2007: Pre-operative visit:		MEDI0007272	1						2	Activated partial thromboplastin time; Bacteria urine; Band neutrophil percentage; Blood chloride increased; Blood creatinine normal; Blood glucose normal; Blood potassium normal; Blood sodium normal; Blood urea normal; Blood urine present; Computerised tomogram abnormal; Culture urine negative; Fibrosis; Full blood count normal; Glomerulosclerosis; Glucose urine absent; Haematocrit decreased; Haemoglobin decreased; Hydronephrosis; Inflammation; International normalised ratio; Laparoscopy; Lymphocyte percentage; Monocyte percentage; Nephrectomy; Neutrophil percentage; Nitrite urine absent; Platelet count normal; Protein urine absent; Prothrombin level normal; Red blood cell count normal; Red blood cell sedimentation rate increased; Red blood cells urine positive; Renal scan abnormal; Specific gravity urine normal; Ultrasound scan abnormal; Ureteric obstruction; Urine analysis abnormal; White blood cell count normal; White blood cells urine positive; X-ray abnormal; pH urine normal	FLUN3~MEDIMMUNE VACCINES, INC.~500486P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Hospitalisation	Influenza
0340169	02/20/2009	NY	0.5	0	.5	M	02/10/2009	Admitted to hospital 2/6/9 for intussusception.  3/9/09 Received hospital medical records of 2/6-2/7/2009. FINAL DX: Ileocecal intussusception Records reveal patient experienced irritability, abdominal pain, curling up in a ball then sleeping immediately after.  Vomited at daycare & in evening had bloody stool.  Taken to ER where dx w/IS & enema reduced.  Admitted overnight for observation, did well & d/c to home.					Y	2			Y	12/22/2008	02/06/2009	46	LABS: Abdominal x-ray & KUB abnormal.  Segs 47%(H), plts 457(H).  Creatinine 8(L), albumin 5.0(H), globulin 2.1(L), AST 42(H).	PVT	PVT		None	None  PMH: Currently w/OM & being tx w/oral antibiotics.  Family Hx: celiac disease, intussusception & lactose intolerance.			1						1	Intussusception	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B079~3~UN~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2787AA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~808702K~3~UN~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0924X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0340170	02/20/2009	FL	1.3	1	.3	M	02/20/2009	Thursday Feb. 5, 2009 fever 102- C was the highest the fever and slight rash on face, no energy, red eyes not eating. Fr. Feb 6, 2009 fever and rash not on face moving to neck and chest. Saturday Feb 7, 2009 no fever but rash moved to chest and back. Urgent care in afternoon for vomiting and diarrhea. Monday Feb 9, 2009 rash still covering body, still not eating, no energy. Tuesday Feb 10, 2009 rash still covering body.				Y					Y	01/27/2009	02/05/2009	9		PVT	PUB			developmental delay			1						1	Anorexia; Asthenia; Dermatitis acneiform; Diarrhoea; Ocular hyperaemia; Pyrexia; Rash; Vomiting	FLU3~SANOFI PASTEUR~UT2785AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB232AA~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0931X~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0953X~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0340173	02/20/2009	WV	4.0	4		F		Redness & warmth of left thigh where KINRIX was administered on 2/17/09				Y					U	02/17/2009	02/18/2009	1		UNK	PUB	SINGULAIR 10 mg, ATORAX 1 1/2 tsp	Eczema	Cat, dogs, dust (NKDA) Eczema, Ocular albinism, Hx of Pylonepariti		WV0902	1						1	Injection site erythema; Injection site warmth	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B103AC~1~IM~LL~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~U2800EA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB329AA~2~IM~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1083X~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1138X~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0340175	02/20/2009	NY	39.0	39		F	02/20/2009	Dizziness, tight chest, hives, and difficulty breathing that lasted for three hours.									Y	09/20/2008	09/20/2008	0	None	PUB	PUB	LYRICA, ULTRACET, ONNORRIS, SASTLINE	None	None			1						1	Chest discomfort; Dizziness; Dyspnoea; Urticaria; Chest discomfort; Dizziness; Dyspnoea; Urticaria	FLUX~UNKNOWN MANUFACTURER~~3~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~2765AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0340176	02/20/2009	NC	74.0			F	02/15/2009	Nauseated, extremely cold chills, dizziness (these conditions lasted four days).									Y					OTH	OTH		None	Asthma			1						1	Chills; Dizziness; Feeling cold; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0340178	02/20/2009	MD	21.0	21		M	02/17/2009	Pt received FLUMIST on 10-8-08, but still tested positive for influenza B on 2-4-09.				Y					Y	10/08/2008	02/04/2009	119	Influenza Test, positive	MIL	MIL						1						1	Influenza; Influenza serology positive	FLUN3~MEDIMMUNE VACCINES, INC.~500589P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0340179	02/20/2009	MD	18.0	18		F	02/17/2009	Pt received FLUMIST on 10-9-08, but still tested positive for influenza A on 1-31-09.				Y					Y	10/09/2008	01/31/2009	114	Influenza Test - Positive	MIL	MIL						1						1	Influenza; Influenza serology positive	FLUN3~MEDIMMUNE VACCINES, INC.~500589P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0340180	02/20/2009	MD	21.0	21		M	02/17/2009	Pt received FLUMIST on 10-8-08, but still tested positive for influenza A on 2-2-09.				Y					Y	10/08/2008	02/02/2009	117	Influenza Test - Positive	MIL	MIL						1						1	Influenza; Influenza serology positive	FLUN3~MEDIMMUNE VACCINES, INC.~500589P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0340181	02/20/2009	MD	17.0	17		M	02/17/2009	Patient received FLUMIST on 10-9-08, but still tested positive for A and B influenza on 12-7-08.				Y					Y	10/09/2008	12/07/2008	59	Influenza Test, positive	MIL	MIL						1						1	Influenza; Influenza serology positive	FLUN3~MEDIMMUNE VACCINES, INC.~500589P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0340182	02/20/2009	NE	48.0	48		F	01/12/2009	Had flu shot in Oct - (first shot ever for flu). By next am lips were swollen and remained for the day. By evening lips started getting dry and chapped and have remained so in particular a spot on upper L lip. Denies changing makeup, new soap, etc.									Y	10/14/2008	10/14/2008	0		PUB	PVT		None	None			1						1	Chapped lips; Lip dry; Lip swelling	FLU3~SANOFI PASTEUR~U2740AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0340238	02/20/2009	PA	5.0	5		F	02/20/2009	The Flu Vaccine was administered at 11:30am on Wednesday, 2/18/2009.  On the way home from her CF appointment, I stopped at our Chiropractor's and had her adjusted at 1:00pm. By 3:00pm, patient started with a fever of 100.3.  By 5pm, the fever was at 102.3 and held there until 2:00am, 2/19, when it spiked to 103.4.  At 9:00am on 2/19, it was 104, she was complaining of not being able to breath and that her heart was splitting in two. I took her to the Chiropractor's again and had left messages with her pediatrician and the Pulmonology Dept. She had short rapid breaths and was weak and had no energy to move.  I was instructed by telephone to give her an Albuterol/Pulmocort breathing treatment and then I took her back down to hospital at 1:00pm 2/19 (it's a 2 hour drive), and Dr. did a thorough examination.  Her lungs were clear and open, (probably due to the breathing treatment.)  Dr. could not say if her symptoms were the result of the flu vaccine and said that she probably had the virus before the vaccine was administered, as they have been seeing children in the hospital with RSV, the flu and strep throat.  They gave patient a dose of Children's Motrin, 1 1/2 tsp (for 35lbs), and told me to alternate Motrin and Tylenol every 4 hours.  At 3:15pm when we got home, her temp was 101.7, and went back up to 102.7 by 6:30pm.  After a dose of Tylenol at 6:30pm, her fever dropped to 99.4 by 8:30pm.  As of 7:00am today, 2/20, her fever is at 100.2.  She is still weak, she is having difficulty eating, saying that the food tastes and smells funny.				Y					N	02/18/2009	02/18/2009	0		UNK	UNK		Patient has Cystic Fibrosis.	Patient has Cystic Fibrosis.			1						1	Asthenia; Dysgeusia; Dyspnoea; Parosmia; Pyrexia; Respiratory rate increased	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0340239	02/20/2009	VA	14.0	14		F	02/20/2009	the day after the vaccine was given the patient noticed, redness, swelling, itching and pain of her right arm.  Dizziness and sleepiness notices as well., vomited x 2, on day 2 the area increased in erythema, elbow was painful., directed to take Motrin, Benadryl and apple cool compresses				Y					U	02/16/2009	02/17/2009	1	None	PVT	PUB			Penicillin allergies			1						1	Arthralgia; Dizziness; Erythema; Oedema peripheral; Pain in extremity; Pruritus; Somnolence; Vomiting	FLU3~SANOFI PASTEUR~U2795BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB329BA~1~IM~RA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~0651X~1~IM~LA~HPV (GARDASIL)~1|VARCEL~MERCK & CO. INC.~1543X~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0340246	02/20/2009	MI	1.3	1	.3	M	02/20/2009	Grandmother called and spoke with RN in clinic on 2/18/09 informing her patient had seizure on morning of 2/18/09, and wanted Dr informed. Phone message transfered to Dr by RN who took call. Grandmother also spoke with receptionist from clinic same morning who transferred her call to Pediatric Neurologist's office. Seizure not witnessed by medical personel. Child has been referred in past to peds neurology, genetics, nephrology, cardiology, dietician, opthamologist, nuerology, home health nurse.									Y	02/17/2009	02/18/2009	1	EEG scheduled 2/25/09 prior to event per Dr note on 2/17/09.	UNK	UNK	Prevacid 3mg/ml - 1.5 ml BID, Hydrochlorothiazide 10mg/ ml - 5 mg BID, Tri-Vi-Sol with Fe 1 ml daily, Robinul 0.2mg/ml-1 ml BID, Lactulose 10GM/15ml 1 tsp BID, Xopenex 0.63 mg/3ml-one in neb every 4-6 hrs PRN, Pulmicort 0.5 mg/2ml-one in ne	No	Wolf-Hirschhorn Syndrome / Sickle Cell Trait / Chronic Renal Failure / Pulmonic Stenosis and Small ASD /Hyperparathyroidism /Developmental Delay /? Visual Impaired / Nissen Fundoplication / Gastrostomy Placement / Sickle Cell Trait / GERD / Hypospadius / Premature Birth, 34 weeks /Hx of aspiration pneumonia			1						1	Convulsion; Electroencephalogram	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B065AA~4~IM~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2792CA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C27703~4~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0340259	02/20/2009	WA	49.0	0	.0	F	11/30/2006	massive headache. Facial swelling w/rash. Lymphandopathy. Prednisone at tapering dose. Doxycycline.				Y					Y	11/17/2006	11/17/2006	0		PUB	PVT		-0-	unk			1						1	Headache; Lymphadenopathy; Rash; Swelling face	FLUN3~MEDIMMUNE VACCINES, INC.~500437P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0340260	02/20/2009	FL	4.0	4		F	02/20/2009	Patient passed out about 10 minutes after receiving 5 vaccinations at her 4 year old well check up.  While under observation, she passed out in her mother's arms.  These episodes could have been mini seizures.  She lost color in her skin and lips, became clammy to the touch and irritable.  Patient was able to leave the drs after 30 minutes.									Y	02/20/2009	02/20/2009	0		UNK	UNK		None	VonWillebrands			1						1	Cold sweat; Irritability; Loss of consciousness; Pallor	DTAP~UNKNOWN MANUFACTURER~~UNK~~~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~~~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~~~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~UNK~~~VARICELLA (NO BRAND NAME)~1	USA		Influenza
0340286	02/20/2009	CA	14.0	14		M	02/20/2009	Fever, cough. Diffuse bilateral pneumonia. Staph aureus MRSA.  5/12/09 Autopsy report states COD as organizing diffuse alveolar damage w/bronchiectasis; multiple bronchopleural fistulas secondary to influenza B & MRSA infection; extensive pleural adhesions.  Autopsy limited to lung only.    4/15/09 Received hospital medical records of 2/16-3/21/2009. FINAL DX: death; influenza B pneumonia w/secondary MRSA pneunonia; ARDS; leukopenia; thrombocytopenia; hyponatremia; coagulopathy; hypotension requiring pressors; high frequency oscillatory ventilation; bilateral pneumothorax; bilateral bronchopulmonary fistulas. Records reveal patient experienced sorethroat, fever, cough, post-tussive emesis x 4-5 days & hemoptysis x 1 day prior to admit w/increased work of breathing.   Admitted PICU for severe respiratory distress secondary to bilat pneumonia & leukopenia.  Pulm, ID, heme consults done.  Patient had long & complicated PICU course while continuously vented, feeding tube, bilateral chest tubes, tracheostomy, multiple blood product transfusions, IV antibiotics & steroids, Tamiflu, IVIG.  Progressively declined, extubated per family request & expired shortly therafter.	Y	03/21/2009	Y		Y	35	Y		U	01/23/2009	02/13/2009	21	Staph Aureus; Infl B positive; X ray chest diffuse pneumonia  LABS: Admit labs: WBC 0.9(L), plts 41K(L)  CRP 26.6(H), RA factor 16(H).Drug screen neg.  Head CT WNL.  Bone marrow biopsy.	PVT	PUB		None	None			1						1	Chest X-ray abnormal; Cough; Influenza serology positive; Pneumonia; Pyrexia; Staphylococcal identification test positive	FLU3~SANOFI PASTEUR~U2808AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0340287	02/20/2009	VA	61.0	61		M	02/16/2009	Tingling both legs and arms with weakness. Muscle weakness (not working right in func). Speech impairment.  4/20/09 Received hospital & rehab medical records (referred to but not included 12/31/2008-1/14/2009), 1/14-1/22/09,  1/22-2/3/09 & 2/3-2/14/2009. FINAL DX: Guillain-Barre syndrome Records reveal patient experienced LE weakness/numbness/tingling & inability to lift legs which had been preceded by possible viral illness.  Tx w/IVIG.  Improved slightly & admitted to inpatient rehab 1/14-1/22/2009.  While in rehab, noted to have worsening facial weakness & dysphagia & was readmitted to hospital 1/22-2/3/2009 for plasma exchange x 5.   Minimally improved & d/c to inpatient rehab 2/3-2/14/2009 where he improved considerably although unable to fully close both eyelids.  D/C home using walker & referred to outpatient PT & ST . Follow-up: Has mild residual weakness.				Y	Y	48	Y		N	10/17/2008	11/15/2008	29	MRTs and CTs; multiple lab test; Spinal tap  LABS: MRI brain 12/31/08 abnormal.  MRI c-spine abnormal w/multilevel spondylosis.  EMG/NCS abnormal.  CSF: wbc 4, rbc 5, protein 118(H), glucose 67(N), c/s neg.  CXR abnormal w/interstitial scarring.	OTH	OTH		No	PMH: PSVT, HTN, hypertensive cardiovascular disease.			1						1	Computerised tomogram; Immunoglobulin therapy; Lumbar puncture; Muscular weakness; Paraesthesia; Speech disorder	FLU3~SANOFI PASTEUR~U2742AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0340294	02/20/2009	CA	77.0	77		F	02/20/2009	Pt reports that she had a flu shot here in our clinic in early December 2007.  Although there is no record of it being administered here.  Dime-sized area on Rt upper arm was crusted over, never healed.  Sent to derm and diagnosed with squamous cell carcinoma.				Y					Y	12/01/2007			Skin biopsy done, pathology -> 10/30/2008 shows squamous cell CA.	UNK	UNK		none known	Hypertension, diabetes, hyperlipidemia			1						1	Biopsy skin abnormal; Squamous cell carcinoma	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0340295	02/20/2009	IL	29.0	29		M		Grand mal seizure. PMH negative.				Y					Y	01/14/2009	01/17/2009	3	MRI/CT negative. Blood Work negative for any neurological indications/infections/ cardiovascular disease.	PVT	UNK		None	None			1						1	Blood test normal; Computerised tomogram normal; Grand mal convulsion; Nuclear magnetic resonance imaging normal	FLU3~SANOFI PASTEUR~U2802AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB252AA~UNK~UN~UN~HEP A (HAVRIX)~1|TDAP~SANOFI PASTEUR~C2927AA~UNK~UN~UN~TDAP (ADACEL)~1|TYP~SANOFI PASTEUR~A0923~UNK~UN~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|YF~SANOFI PASTEUR~UF307AB~UNK~UN~UN~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0340298	02/20/2009	NC	8.0	8		M	02/13/2009	Child presents with pain in upper right arm.  Outer aspect of upper arm is noted to be red, raised, increased temp hard & 35 mm x 25 mm blistered weaping area noted in center of site.				Y					U	02/11/2009	02/12/2009	1	Unknown - Pt sent for M.D. evaluation on 2-13-09.	PUB	PUB	None	Mom reports - mild dry cough	None			1						1	Erythema; Induration; Injection site pain; Injection site vesicles; Skin warm	FLU3~SANOFI PASTEUR~U2798DA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB246AA~1~IM~LA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~1223X~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0340270	02/21/2009	FL	47.0	47		F	02/21/2009	EXPERIENCED ITCHING ,SHORTNESS OF BREATH, HEAVINESS IN CHEST DIFFICULTY BREATHING,  RASH ,REDDNESS SWELLING ALSO HAD FEVER CHILLS OVERALL WEAKNESS WITH NUMBNESS AND TINGLING IN ARMS AND FACE.				Y					Y	01/29/2009	01/29/2009	0		MIL	UNK		N/A	SULFA DRUGS			1						1	Asthenia; Chest discomfort; Chills; Dyspnoea; Erythema; Hypoaesthesia; Hypoaesthesia facial; Paraesthesia; Pruritus; Pyrexia; Rash; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0332681	02/23/2009	NM	38.0	49		F	02/23/2009	SWELLING AND PAIN AT INJECTION SITE, FEVER, ELEVATED BLOOD PRESSURE									Y	10/28/2008	10/30/2008	2		PVT	PVT						1						2	Blood pressure increased; Injection site pain; Injection site swelling; Pyrexia; Arthralgia; Blood culture; Full blood count; Injection site erythema; Injection site swelling; Metabolic function test; Pain in extremity; Pyrexia	PPV~MERCK & CO. INC.~1383U~2~IM~RA~PNEUMO (PNEUMOVAX)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|PPV~MERCK & CO. INC.~1667U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~3	USA		Influenza
0332681	02/23/2009	NM	49.0	49		F	02/20/2009	Information has been received from a healthcare worker concerning a 49 year old female with hypertension who on 28-OCT-2008 was vaccinated IM with PNEUMOVAX 23, 0.5ML (lot# 659922/1667U). It was reported the patient had received a pneumococcal vaccine in the past (date and manufacturer not specified). Concomitant therapy included influenza virus vaccine (manufacturer unspecified) and lisinopril (manufacturer unspecified). On 29-OCT-2008 the patient experienced arm pain, swelling and redness at the injection site, a fever of 101 degrees F and hip and joint pain. The patient was treated in an Emergency Room for fever. Complete blood count, complete metabolic profile and blood cultures were performed (results unknown). Her symptoms lasted 5-7 days. Subsequently, the patient recovered from arm pain, swelling and redness at the injection site, a fever of 101 degrees F and hip and joint pain. The reporter considered swelling and redness at the injection site, arm pain, a fever of 101 degrees F and hip and joint pain to be disabling. This is one of several reports from the same source. Additional information has been requested.				Y				Y	Y	10/28/2008	10/29/2008	1	Unknown	OTH	OTH	Lisinopril	Hypertension	Immunisation		WAES0902USA02933	1						3	Blood pressure increased; Injection site pain; Injection site swelling; Pyrexia; Arthralgia; Blood culture; Full blood count; Injection site erythema; Injection site swelling; Metabolic function test; Pain in extremity; Pyrexia	PPV~MERCK & CO. INC.~1383U~2~IM~RA~PNEUMO (PNEUMOVAX)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|PPV~MERCK & CO. INC.~1667U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~3	USA	Disabling	Influenza
0340341	02/23/2009	NM	58.0	58		F	02/20/2009	Information has been received from a healthcare worker concerning a 58 year old female with allergy to VICODIN and MINOCIN who on 21-JAN-2009 was vaccinated IM with the first dose of PNEUMOVAX 23, 0.5ML (lot# 659922/1667U). Concomitant therapy included influenza virus vaccine (manufacturer unspecified), ZANTAC, VENTOLIN, SYMBICORT, RESTORIL, PREMARIN, NASONEX, CENTRUM, and ACIDOPHILUS. On 21-Jan-2009 the patient developed arm pain, swelling and redness at the injection site. Subsequently, the patient recovered from arm pain, swelling at the injection site and redness at the injection site. The patient sought medical attention in the office. The reporter considered arm pain, swelling and redness at the injection site to be disabling. This is one of several reports from the same source. Additional information has been requested.				Y				Y	Y	01/21/2009	01/21/2009	0	None	OTH	OTH	ACIDOPHILUS; VENTOLIN (ALBUTEROL); SYMBICORT; PREMARIN; CENTRUM; NASONEX; ZANTAC; RESTORIL	Drug hypersensitivity			WAES0902USA02926	1						1	Injection site erythema; Injection site swelling; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1667U~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0340361	02/23/2009	OH	1.05	1	.1	M	02/18/2009	Pt developed trunkle red micropapule rash 2 wks post MMR									Y	02/06/2009	02/16/2009	10	None	PUB	PUB	TYLENOL; MOTRIN, PRN	None	None			1						1	Rash; Rash erythematous; Rash papular	FLU3~SANOFI PASTEUR~UT2792CA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB262AA~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1081X~1~SC~RL~MEASLES + MUMPS + RUBELLA (VIRIVAC)~1|PNC~PFIZER\WYETH~C71571~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1010X~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0340369	02/23/2009	NC	56.0	56		F	02/16/2009	L arm sore and client dizzy evening after shot.  Next morning left arm swollen and client began to shiver and low grade fever 100 degrees F.  Very reddened spots underneath the band aid.  Dx. 1/29/09 @ MD othce with cellulitis.				Y					Y	01/27/2009	01/27/2009	0	TSH, CBC	PUB	PVT	None	None	None			1						1	Blood thyroid stimulating hormone; Cellulitis; Chills; Dizziness; Erythema; Full blood count; Injection site pain; Injection site swelling; Pyrexia	FLU3~CSL LIMITED~02249111A~UNK~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~0804V~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0340370	02/23/2009	MI	65.0	65		F		Acute onset of excruciating right shoulder and upper arm pain following flu virus immunization. Pain intensity very high (9+/10) and maximal at onset. Pain is sharp and throbbing and constant since injection. Deep aching and muscle weakness and atrophy in upper right arm. Also, sharp/shooting pain affecting eyes and head. Numbness and muscle weakness continuing chronic right upper arm and shoulder pain, significant muscle weakness continuing with physicians for diagnostic work up. 4/3/09-records received-office visit 1/21/09-C/O 3 months of right upper arm lateral aspect being painful with decreased strength. 4/16/09 neurology consult received for DOS 12/16/08-C/O headaches with black spots in front of eyes. Anxiety worsenes tension type headaches.  Impression: chronic daily headaches both migraine and tension type and analgesic rebound headache. Daytime somnolence snoring and gasping respiration and weight gain. Lancinating headaches. 2/2/09-C/O right upper arm pain since receiving flu shot.				Y					N	10/01/2008	10/02/2008	1	Neuropathy, abnormal EMG and nerve conduction study 2/09/2009. Physical therapy, blood labs, (CBC), (ANA) ordered. 4/3/09-records received-EMG and nerve conduction study abnormal evidence of minimal right sided median neuropathy loss of sensory action potential amplitude, this study fails to demonstrate electrodiagnostic evidence of superimposed cervical radiculopathy, peripheral polyneuropathy or myopathy. X-ray negative. X-ray negative. PE:normal. 4/16/09-records received-EMG and nerve conduction study abnormal of right upper extremity with minimal right sided medical neuropathy characterized by loss of sensory action potential amplitude.	OTH	PUB	NORVASC, NEXIUM, TOPROL, SYNTHROID, BENICAR, ALDACTONE, PREMARIN	No illness	Arrhythmia, migraines, hypothyroidism, hypertension, degenerative dise disease.  4/3/09-records received-PMH:HTN, arrhythmia with PVCs, hypothyroidism, HRT, GERD, chronic low back pain with sciatica, osteoarthritis.  4/16/09-records received-PMH migraine headaches and daily headaches for 20 years.			1						1	Electromyogram abnormal; Eye pain; Headache; Hypoaesthesia; Injection site atrophy; Injection site pain; Muscular weakness; Musculoskeletal pain; Myalgia; Nerve conduction studies abnormal; Neuropathy peripheral; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89881~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0340374	02/23/2009	IA	1.5	1	.5	F	02/16/2009	Hives started 2 days after flu vaccine ? allergy to eggs.				Y					Y	02/11/2009	02/14/2009	3	None	PUB	PUB	None	None	None			1						1	Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B087AA~4~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~SPU2847AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~D15051~1~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0340384	02/23/2009	PA	15.0	15		F	02/12/2009	Headache - post immunization evening - continuing at time/date of call on 02/12/09. Given MOTRIN by mother - Mother related - Some relief - but once MOTRIN dose wore off - teen c/o headache again.									U	02/11/2009	02/11/2009	0		PUB	OTH			None Known or indicated on IMZ record			1						1	Headache	FLU3~SANOFI PASTEUR~U2769AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB247AA~1~IM~RA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~0575X~1~IM~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~62733AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0340386	02/23/2009	WI	29.0	29		M	02/21/2009	Soon after receiving the tetanus, influenza and meningococcal vaccines and having blood drawn, service member complains of ringing in his ears, lightheadedness, unable to hear (deafness), dry mouth and difficulty breathing. He was given epinephrine 0.5 cc SQ.									Y	02/21/2009	02/21/2009	0	Service member has had tetanus and influenza vaccines in the past w/no adverse events. He had not had meningococcal vaccine.	MIL	UNK		None				1						1	Deafness; Dizziness; Dry mouth; Dyspnoea; No reaction on previous exposure to drug; Tinnitus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA168AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|MNQ~SANOFI PASTEUR~U2817AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TD~AVENTIS PASTEUR~U2287CA~UNK~IM~RA~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0340428	02/23/2009	NY	5.0	5		M	02/23/2009	Per mom-since the vaccines pt. has had fevers, headaches & generalized weakness.  Just prior to admit.  noted visual problems and gait problems.  3/19/09 Received hospital medical records of 2/13-2/23/2009. FINAL DX: ADEM Records reveal patient experienced intermittent fever, HA, lethargy & irritability x 30 days & 3 days s/p vaccination.  Developed ataxic gait & visual changes 3 days prior to admit.  ID, Neuro consults & LP done.  Initially tx w/IV antibiotics for presumed menigitis.  No steroids & antiobiotics d/c.  Resolved spontaneously & d/c to home.  4/27/09 Case closed as incomplete.  Have not received vaccine records from PCP.  Will reopen should additional information become available.					Y	11				01/13/2009	01/14/2009	1	MRI->ADEM  LABS: MRI brain abnormal. Neutros 65.6%(H), lymphs 26.2%(L).  CRP 0.07(N).   ESR 33(H).  CSF: protein 44(N), glucose 49(N), WBC 48(H), RBC 2, neutros 46%(H), lymphs 52%(N), c/s neg.  Blood & urine c/s neg.	UNK	UNK		None known to us	PMH: strep throat 12/08 & recurred 1/09.			1						1	Acute disseminated encephalomyelitis; Asthenia; Gait disturbance; Headache; Nuclear magnetic resonance imaging abnormal; Pyrexia	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0340519	02/24/2009	FL	12.0	12		F		Quick fever up to 103.3 degrees F, congestion, cough soreness in throat;									U	10/29/2008	02/18/2009	112	Flu A +	PVT	PVT		None	None			1						1	Cough; Influenza serology positive; Oropharyngeal pain; Pyrexia; Respiratory tract congestion	FLU3~SANOFI PASTEUR~U2839AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0340527	02/24/2009	IN	8.0	8		F	02/19/2009	Received flu shot 2-16-09 came to office 2-18-09 left upper arm red & swollen & hard 5 cm no rash									Y	02/16/2009	02/16/2009	0	None	PVT	OTH		No	None			1						1	Injection site erythema; Injection site induration; Injection site swelling	FLU3~SANOFI PASTEUR~U2898EA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0340564	02/24/2009	UT	68.0	68		F	02/24/2009	Pneumococcal vaccination given on 2/22/09 @ 1000.  The patient did not experience any symptoms until 2/23 when she noticed her Left Deltoid was hot, raised and began to itch.  Benadryl was given on 2/23 at 2300 and the redness continued to spread to approximately a 4x4 area. By 1500 on 2/24 the deltoid was still raised and somewhat hot but the swelling had decreased to about 3 x 3 and did not itch.  A second dose of benadryl was given at 1500 due to some discomfort.									Y	02/22/2009	02/23/2009	1		PUB	UNK		Ventral Hernia repair on 2/3/09, discharged 2/6/09. Presented back to the hospital on 2/19/09 with L Lower lobe Pulmonary embolism.	Allergy to Abilify - dysphagia, hand tremors.			1						1	Injection site discomfort; Injection site pruritus; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2772A~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~9722106~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0340567	02/24/2009	CA	4.0	4		M	02/24/2009	Redness of face around eyes; no swelling.  Per parents, occurred immediately after vaccine; did not call MD until several hours after immunized.  Treatment given: Benadryl.  Recommended to give Epi Pen & go to Emergency Room when spoke with MD, as child with egg allergy.  Parents declined to go to ER.  Will consider Epi Pen, if child worsens.									Y	02/23/2009	02/23/2009	0	None	MIL	MIL	Singulair, Flonase	None	Egg allergy; asthma; Peanut allergy; shellfish allergy			1						1	Erythema; Immediate post-injection reaction	FLU3~SANOFI PASTEUR~U2791DA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0340577	02/24/2009	TN	0.7	0	.7	M	02/24/2009	Reported from mother: Pt was admitted to hospital 2-18-09 due to fever 104.6. Stated blood culture done in ER was (+) for bacterial infection. Repeat blood cultures on Friday were negative. Stool cultures done were negative. Pt was released home 2-21-09 in a.m. with Rx AZITHROMAX. Spoke with mother 2-24-09 states pt doing well with no fever and has been Tx with antbx.  2/25/09 MR received for DOS 2/19-21/2009 with DX: Fever w/o source.  Leukocytosis.  Pt presented with 2 day hx of fever. Received vax today and fever up to 104.6. PE (+) for cough and rhinorrhea, mild tachycardia. Admitted for observation and tx with abx.					Y	3			Y	02/18/2009	02/18/2009	0	1/10/09 WBC's increased 23.5 k/ul per PCP. Labs:  WBC 17.9, 26% lymphs, 59.9% neutros.  Flu (-). Strep (-). CXR (+) mild perihilar and peribronchial inflammatory changes c/w bronchitis early pneumonia.	PUB	UNK	Albuterol Nebulizer; Hx taking ZANTAC		12-30-08 DX with RSV; 7-20-08 DX with GERD; 1/10/09 Acute Bronchitis PMH:  RSV			1						1	Bacterial infection; Blood culture positive; Culture stool negative; Pyrexia; White blood cell count increased	DTAPIPVHIB~SANOFI PASTEUR~C3231AA~1~IM~LL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~UT2799FA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~D05882~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0340578	02/24/2009	WA	1.4	1	.4	M	02/24/2009	Cellulitis Right thigh				Y					U	02/23/2009	02/23/2009	0		PUB	PUB		None	None			1						1	Injection site cellulitis	FLU3~SANOFI PASTEUR~UT2794EA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0340659	02/25/2009	MI	46.0	46		F	02/23/2009	This non-serious event was reported by a health care professional on 13 January 2009. Based upon additional information received on 13 February 2009, it was determined this case meets seriousness criteria. This patient is one of a cluster of 20 patients: the other 19 patients are captured in case numbers 2008-03509, 2009-00153 to 2009-001164, 2009-00166 to 2008-00171. SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. A female patient, had received an injection of FLUZONE SV 2008-2009 (lot number U2762AA) on 19 October 2008; however the route and site of administration were not provided. On 13 November 2008, the reporter recorded that at an unspecified amount of time after vaccination, the patient had a sore arm and the pain was up into her neck. The patient was seeing her primary care physician; however, it was not reported whether the patient required treatment for the events. Outcome was not reported. Follow-up information was received 13 February 2009 from a health care professional. The patient received an intramuscular left deltoid injection of FLUZONE and the left arm soreness began 24 to 48 hours post vaccination. The patient was seen by their primary care physician and an X-ray of her left arm was negative. The patient was prescribed VICODIN for pain and fully recovered in two to three months. It was further noted that the patient had a history of a pulled muscle in her left arm. Due to this new information received, this case has been upgraded from non-serious to serious. Documents held by sender: None.				Y					Y	10/19/2008			X-ray of left arm: negative	PVT	PVT			The patient had a history of a pulled muscle in the left arm.		200900165	1						1	Neck pain; Pain in extremity; X-ray normal	FLU3~SANOFI PASTEUR~U2762A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0340669	02/25/2009	MA	11.0	11		F	02/20/2009	Received a BOOSTRIX vaccine (R) arm 10/30/08. Seen on 11/2/08 area red swollen, hot to touch.										10/30/2008	11/01/2008	2		PVT	PVT		None	None			1						1	Erythema; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U2766AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2727AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B030AA~1~IM~RA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1002X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0340672	02/25/2009	OH	1.01	1	.0	F	02/23/2009	Per parent, child had routine immunizations on 02/11/09.  Infant jerked right leg slightly at the time of getting the shot, and small bruise appeared on right thigh after immunizations.  On 02/21/09 child developed a dime-sized, slightly raised, red spot on right thigh.  She has no fever, no tenderness to touch, or any other symptoms. Parent reported to county health district on 02/23/09.									U	02/11/2009	02/21/2009	10		UNK	UNK	None, per parent	None, per parent	None, per parent			1						1	Injection site erythema; Injection site haematoma; Injection site swelling	DTAP~SANOFI PASTEUR~U2471BA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT2792EA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1297X~1~IM~LL~HEP A (VAQTA)~1|MMR~MERCK & CO. INC.~0266X~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C73466~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1742~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0340682	02/25/2009	TX	3.0	3		F	02/23/2009	On 10/17/09 patient was taken to hospital for seizure activity. At hospital she was intubated for respiratory failure. Mother reported low grade fevers at home. She was given fosphenytoin and started on maintenance IV fluids. Head CT was done and noted as stable. Blood cultures and urine cultures were negative 3/6/09-records received for DOS 10/17-10/20/08-DC DX:Status epilepticus. Respiratory distress. Positive Influenza B. Urinary retention. Presented to ED with C/O seizure activity, followed by lip smacking and left leg jerking. Became apneic with desaturations to the 60s, intubated for respiratory failure. Low grade fever at home.				Y	Y	3			Y	10/15/2008	10/17/2008	2	She was given fosphenytoin and started on maintenance IV fluids[[address]]Head CT was done and noted as stable[[address]]Blood cultures and urine cultures were negative[[address]]Rapid strep negative[[address]]DFA positive for influenza Chest x-ray showed linear atlectasis. 3/6/09-records received-Head CT stable and unchanged[[address]]Rapid strep negative[[address]]Blood and urine cultures negative[[address]]DFA positive for influenza[[address]]Chest x-ray showed atelectasis[[address]]	UNK	UNK		Patient had congestion and rhinorrhea five days prior. 3/6/09-records received- Congestion and rhinorrhea one week prior.	Underlying medical conditions including congenital CMV, microcephaly, cerebral palsy and pre-existing seizure history. 3/6/09-records received-PMH: CP, seizure disorder and Congenital CMV. Chronic constipation.			1						1	Blood culture negative; Chest X-ray abnormal; Computerised tomogram normal; Condition aggravated; Convulsion; Culture urine negative; Endotracheal intubation; Influenza; Influenza serology positive; Pyrexia; Respiratory failure; Scan brain; Streptococcal identification test	FLU3~SANOFI PASTEUR~UT794GA~1~IN~NS~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0340685	02/25/2009	CA	62.0	62		F	02/25/2009	In January patient reported pain on entire arm lasting for more than 3 weeks										10/23/2008				UNK	PVT	Coumadin, Synthroid					1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2751AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0340706	02/25/2009	MI	50.0			U		Injection administered 10-17-08, on 10-23-08 pt seen by PA-C for wide spread hives on palms and soles. Tenderness to area of injection, no swelling or signs of infection. Pt seen on 2-17-09 injection site still painful.									U					OTH	OTH						1						1	Injection site pain; Urticaria	FLU3~SANOFI PASTEUR~U2749AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0340712	02/25/2009	IN	4.0	4		M	02/24/2009	Within 30 minutes patient experienced moderate swelling and mild erythema of left thigh extending to superior portion of knee joint. The joint was not involved. No warmth noted. From of knee and hip. Reflexes and motor strength were normal and limping was observed. Treated with Motrin and Benadryl as needed.									Y	10/20/2008	10/21/2008	1		PVT	PVT	Pulmicort, Albuterol, Tylenol	Swallowed foreign body in alimentary tract	Reactive Airway Disease			1						1	Gait disturbance; Injection site erythema; Injection site swelling	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B103AB~1~UN~LL~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~U2755AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0330623	02/26/2009		69.0			F	02/25/2009	Initial report received on 05 November 2008 from the Centers for Disease Control and Prevention (VAERS ID# 330623-1). An elderly patient (demographics not provided, and age reported 65+ years) who had no pre-existing illness, had received a dose of influenza vaccine (Trade name and manufacturer name unknown) on 29 October 2008. The date of vaccination, route and site of administration were not provided. The same day of vaccination (date and time not provided), the patient experienced nausea, wheezing, shortness of breath, throat swelling and eye redness. The patient was taken to the hospital, and en route experienced a small seizure. It was not reported whether the patient was admitted to the hospital or not. It was also not reported whether any relevant diagnostic testings were performed. The recovery status of the patient was not reported. 24 February 2009: During the review of FLUZONE VAERS reports extracted using Q-SCAN, it was identified that case 2009-00560 (VAERS ID 330623-1) is a duplicate of the case 2008-03486 (VAERS ID 330623). A new version was created for both cases; the information from case 2009-00560 was added to this case (which will be case of reference) and is recorded in the narrative below, along with additional information received from a search of the VAERS database. Case 2009-00560 will be nullified and subsequently logically deleted. The patient is a 69-year-old female who had received an intramuscular injection of FLUZONE SV 2008-2009 (Lot number U2811) on 29 October 2008. The site of administration was not provided. The patient required intervention to prevent permanent impairment/damage and was hospitalized. Diagnostic tests and laboratory data were performed that included a CBC, Chem 7 and PA/lateral chest x-ray; however results were not provided. The patient recovered (date not provided). Documents held by sender: None.					Y	0			Y	10/29/2008	10/29/2008	0	CBC; Chem 7 and pa/lateral chest X-ray; however results were not provided.	UNK	UNK			The patient had no pre-existing illnesses. Relevant past medical history was not provided.		200803486	1						2	Chest X-ray; Convulsion; Dyspnoea; Full blood count; Laboratory test; Nausea; Ocular hyperaemia; Pharyngeal oedema; Wheezing; Chest X-ray; Convulsion; Dyspnoea; Full blood count; Laboratory test; Nausea; Ocular hyperaemia; Pharyngeal oedema; Wheezing	FLU3~SANOFI PASTEUR~U2811~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~U2811~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Hospitalisation	Influenza
0340782	02/26/2009	CA	54.0			F	02/24/2009	Patient received  a flu vaccine on 10/15/2008.  That evening she felt ill and went to sleep.  She awoke in the middle of the night to drink water and fainted. When she came to, she began to vomit.  The following day, the patient stated she was fine.  She did not seek medical attention for her symptoms.										10/14/2008	10/16/2008	2		UNK	UNK			Perimenopausal, otherwise no significant medical history.			1						1	Malaise; Syncope	FLU3~SANOFI PASTEUR~U2767AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0340787	02/26/2009	ME	1.1	1	.1	F	02/20/2009	Pt with runny nose, fuzziness and 2 lesions on back.				Y						02/06/2009	02/06/2009	0		PVT	PVT	None	None	None			1						1	Irritability; Rhinorrhoea; Skin lesion	FLU3~SANOFI PASTEUR~UT2794GA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1405X~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0340798	02/26/2009	AR	52.0	52		M	02/26/2009	Shot adminstered at work. A week after shot, I began to have difficulty swallowing. The difficulty increased and visited doctor on 12/1.  On 12/2 was ordered to go to hospital for tests and feeding. Remained in Hospital for 23 days to test for cause. None diagnosed. After 3 weeks at home, went to clinic for second diagnosis. Again no set diagnosis, was given medication to take care of symptoms (double vision, facial tingle, and increased salivation.) Clinic decided to call it Cerebral Encephilitis. Said time was the only thing that would cure symptoms.  5/21/09 Received Neuro consult for 1/20-1/27/2009. FINAL DX: suspected brain stem inflammatory syndrome; hyperactive gag reflex due to same; dysphagia w/PEG tube; right trigeminal motor neuropathy; probable pseudobulbar palsy; fluctuating allodynia w/vomiting; diagonal double vision, normal neuro-ophtho exam. Records reveal patient experienced pain & tingling of right thigh w/raised rash.  Saw PCP 10/08 & dx w/zoster flare.  Tx w/antivirals.  Initially improved but the recurred about 6 wks later, tx again w/antivirals.  On 11/21 had choking spell that progressed in frequency & severity until by Thanksgiving very difficult to swallow.  On 11/30 while burning shrub, developed pain & tingling of head & neck, ear redness & nausea which subsequently became daily episodes when even a breeze was painful.  Developed facial rash w/o blisters in 12/08.  Saw PCP & tx w/antibiotic but was unable to swallow pill or even drink H2O.  Admitted to hospital on 12/3.  25# wt loss, hyperactive gag reflex, chills, sleeping sitting up due to choking sensation, anxiety, voice changes, phlegm, persistent double vision, ear fullness, recent thrush, 1 episode SOB.  Neuro-ophtho consult done & WNL.  EMG revealed right trigeminal motor neuropathy.  Facial reflexes very hyperactive c/w pseudobulbar dysfunction.  3/12/09 Received PCP medical records of 12/1/08-2/4/2009. FINAL DX: encephalitis of unknown cause affecting only brainstem; severe dysphagia. Records reveal that on 12/1/08 patient experienced sore throat, facial kin tingling, facial tightness/pressure, itching eyes/nose, difficulty sleeping, voice changes, HA & fever x 1 wk.  Was recovering from w/shingles pain although no vesicles.  RTC 2/4/09 s/p hospitalization x approx 1 mo where he received plasmapheresis.  Currently having facial tingling & difficulty swallowing, neck tension pain, generalized weakness, weight loss, feeding tube insertion & was going to swallow therapy & PT.  3/30/09 Received hospital medical records of 12/3-12/25/2008. FINAL DX: neurogenic dysphagia, unknown etiology; malnutrition requiring PEG placement. Records reveal patient experienced progressive dysphagia approx 12 days prior to admit, w/HA & facial pain/tingling after recent bout of presumed shingles(no rash).  Tx w/antivirals & steroids.  Feeling unwell x 2 mo.  No reactions to prior flu shots.  Neuro & ENT consults done, both of which were WNL.  Oropharyngeal video revealed aspiration.  Received plasmapharesis x 5 for possible GBS variant w/minimal improvement.  Able to manage secretions w/suctioning & d/c to home w/tube feedings w/Neuro & ENT f/u.			Y	Y	Y	23	Y		N	11/19/2008	12/02/2008	13	Spinal taps, CT scans, MRI's, Numerous blood work ups, ECG's, tests for Guillain Barre, myasthenia gravis, HIV, Lyme, stroke, et. al. All test came back negitive. Clinic summized that all pointed back to brain stem activity and arrived at the diagnosis of Cerebral Encephilitis.  LABS: EMG face abnormal.  EMG/NCS of right leg WNL.  Autonomic reflex screen abnormal w/adrenergic & possible distal postganglionic pseudomotor failure.  Anhidrosis of legs & arms on thermoregulatory sweat test.  PFTs WNL.  CSF protein 63(H).  Repeat MRI head under anesthesia w/& w/o contrast WNL.  LABS: CBC, CMP, ANA, CRP WNL.  All cultures neg.  CT neck, EGD, oropharyngeal video abnormal.	UNK	UNK	prevestatin 40 mg	None	None  PMH: hyperlipidemia, jaw movement disorder, shingles.	none~ ()~~0.00~Patient		1						1	Computerised tomogram normal; Diplopia; Dysphagia; Electrocardiogram normal; Encephalitis; HIV antibody negative; Lumbar puncture; Nuclear magnetic resonance imaging normal; Paraesthesia; Salivary hypersecretion	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0340800	02/26/2009	FL	16.0	16		M	02/26/2009	Vaccine administered on 1/14/2009 and developed neurologic symptoms on or about 1/23/2009.  He was subsequently diagnosed with Guillian Barre.  He was treated with IVIG and did remarkably well.  He is almost back to baseline but not quite.  In PT. Follow up received 03/15/2010. Some resolved neurologic symptoms the last I heard. Mostly recovered.  4/10/09 Received hospital medical records for 1/27-2/5/2009. FINAL DX: Guillain Barre syndrome Records reveal patient experienced progressive difficulty walking, dysesthesias, paresthesias, loss or reflexes x 2-4 days.  Admitted ICU.  Tx w/IVIG x 5 days.  Gradually improved but reflexes remained absent at transfer to inpatient rehab facility.			Y	Y	Y	14	Y		U	01/14/2009	01/23/2009	9	LABS: MRI spine WNL.  CSF: RBC 2, WBC 5, protein 77(H), glucose 69, c/s neg.	UNK	UNK	none	none	Penicillin allergic			1						1	Blood product transfusion; Guillain-Barre syndrome; Neurological symptom	FLU3~SANOFI PASTEUR~U2757AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0340818	02/26/2009	WI	59.0	59		F	01/08/2009	Pt called clinic reporting SOB, throat feels funny.  Instructed to go to ER.  At ER, patient did well and left with BENADRYL.  There was some confusion of symptoms related to new use of Niacin but symptoms did not recur.				Y					Y	12/11/2008	12/11/2008	0		PVT	PVT			Allergies- Morphine, adhesive tape, HCTZ, Verapamil			1						1	Dyspnoea; Throat irritation	FLU3~SANOFI PASTEUR~U2742AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C3031AA~UNK~IM~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0340820	02/26/2009	WA	10.0	10		M	02/11/2009	None Phenyl & Pt sister PKU + mom strong on mercury free.  Physician ordered wrong in Epic									Y	01/05/2009				PVT	PUB	RITALIN 10 mg daily started 1-5-2009	None	Amblyopia OD			1						1	No adverse event	FLU3~SANOFI PASTEUR~UT2794CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0340822	02/26/2009	CA	10.0	10		M	11/12/2008	Upon leaving the clinic per mother, pt fainted, Dr responded, SPO2 100-98%. Pulse low. Oxygen given to pt after 10 min. Pt able to stand ambulate and was responsive (vomited 1 time).									Y	11/10/2008	11/10/2008	0		PVT	PUB	None	None	Exercise-induced asthma	None~ ()~~0.00~In Patient|Unknown~ ()~~0.00~In Sibling	CA080024	1						1	Heart rate decreased; Syncope; Vomiting	FLU3~SANOFI PASTEUR~U2795AA~3~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0340824	02/26/2009	ID	47.0	47		F	11/20/2008	Rash, itching, took BENADRYL 50mg followed by 25 mg Q6 hour.									Y	11/19/2008	11/19/2008	0	None	PVT	UNK		None	Kiwi			1						1	Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA336BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0340825	02/26/2009	ID	37.0	37		F	12/10/2008	L arm injection site with large reddened/warm site- Better today.									Y	12/09/2008	12/10/2008	1	None	PUB	PVT	None	No	None			1						1	Injection site erythema; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA356BA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|VARCEL~MERCK & CO. INC.~9724308~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0340826	02/26/2009	ID	40.0	40		F	11/19/2008	Site of injection hot to touch, red and swollen.									Y	11/18/2008	11/19/2008	1		PVT	PVT						1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~0916X~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0340848	02/27/2009	MN	68.0	68		F	02/12/2009	On 2/12/2009 Pt. talked with PHN + and she stated she had a reaction to her Flu shot-stated she had a temperature + chills, stated she could hardly walk to bathroom.   Sore arm, Ached so bad she had nightmares + wasn't able to sleep.  Stated her left side + Lt arm itched.  Stated when she started to feel better, she got a bad cold.  Later stated she thought may be the itching was from dry skin.									Y	10/15/2008	10/15/2008	0		PUB	PVT		None	None			1						1	Body temperature increased; Chills; Dry skin; Gait disturbance; Nasopharyngitis; Nightmare; Pain in extremity; Pruritus; Sleep disorder; Tenderness	FLU3~SANOFI PASTEUR~U2765AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0340850	02/27/2009	NC	0.8	0	.8	F	02/23/2009	Patient was administered diluent for ACT HIB vaccine only without reconstitution of HIB vaccine, but telephone call to mother to advise of error.  Mother noted child with no adverse reaction per reporter.									Y	02/23/2009	02/23/2009	0		PVT	PUB		None	None			1						1	No adverse event; Wrong drug administered; Wrong technique in drug usage process	FLU3~SANOFI PASTEUR~U2847AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0340856	02/27/2009	WI	26.0	26		M	02/24/2009	This service member contacted the 24 hour vaccine call center to report reproducible flu-like symptoms of nausea, vomiting, low grade fever and diarrhea that occurred 5-6 days after receipt of ANTHRAX vaccine #1 and #2.  Received ANTHRAX, influenza (injectable), and TYPHOID vaccines in preparation for deployment the end of Feb 09 on 16 Dec 08.  Had no immediate significant local reaction and no systemic symptoms.  Approximately 6 days later he developed severe vomiting, diarrhea and joint aches that lasted about 24 hours.  The rest of the family had similar symptoms.  Patient fully recovered.  Service member received ANTHRAX vaccine #2 on 27 or 28 Jan 09 while in the field (according to the new dosing schedule that eliminates the 2nd 2 week dose.)  He reports he was clinically well at the time.  No other vaccinations were given simultaneously.  Six days later he developed severe vomiting (6-7x in 24 hours) and diarrhea (12-13 x in 24 hours) and low grade temp of 100.7.  States he also had a shortness of breath, tightness in the chest and Tachycardia for a few hours.  Went to see his civilian PCP for evaluation.  No labs drawn or medications given.  No one else in the home ill.  Slept 16 hours.  Feeling better within 24 hours.				Y					Y	12/16/2008	12/22/2008	6	None	MIL	MIL	None	None	Seasonal allergies			1						1	Arthralgia; Chest discomfort; Diarrhoea; Dyspnoea; Influenza like illness; Nausea; Pyrexia; Tachycardia; Vomiting	ANTH~MICHIGAN DEPT PUB HLTH~FAV149~UNK~UN~UN~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0340874	02/27/2009	ND	58.0	58		M	02/27/2009	Pt called and spoke with RN on 2/19/09 with c/o tremors and high BP since vaccination on 11/4/08.  She reported that she did not know side effects of vaccination but would check with other RN.  Other RN called pt on 2/23/09.  He reported fluctating blood pressure: 200/100's to below 100/50's.  C/o intermittent tremors.  Pt stated that he didn't have these symptoms prior to vaccination and have persisted since.  Pt saw PA-C on 11/13/08 and several times since.  Pt has also seen MD.  BP meds have been added and adjusted.  Also c/o left arm deltoid pain without redness, swelling or palpable lump.				Y					U	11/04/2008	11/05/2008	1	TSH normal	UNK	UNK	Enalapril 20 mg po daily	none	Allergy: tranquilizers  diagnosis: hypertension			1						1	Blood pressure fluctuation; Blood thyroid stimulating hormone; Pain in extremity; Tremor	FLU3~SANOFI PASTEUR~U2670AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2889AA~1~IM~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0340877	02/27/2009	FL	60.0	60		M	02/27/2009	Generalized joint/body ache, weakness, fever (flu-like symptoms). The following day, patient reported pain (10/10) in left shoulder and left leg, brought down to 7/10 after administration of ketorolac 30 mg I.V. once.				Y					Y	11/14/2008	11/14/2008	0		MIL	OTH						1						1	Arthralgia; Asthenia; Influenza like illness; Musculoskeletal pain; Pain; Pain in extremity; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0340887	03/02/2009	WA	13.0	13		M	03/02/2009	Loss of eyesight starting at about two weeks after immunization. Optic neuritis.  3/3/09 MR received for DOS 12/4-8/2008 with D/C DX:  Optic Neuritis. Pt presented with c/o worsening vision x 6 days. Initially L eye went blurry and several days later R eye. Started on prednisone with improvement noted by day 4. D/C on oral pred.   10/30/09 Medical record received for DOS 12/04/08- 10/15/2009 Adolescent c/o decreasing vision bilat 13 days  s/p vaccine. Unable to read.  MRI positive for optic neuritis. Admit for IV steroid therapy. Sight returning by day 4 w/ improvement of light sensitivity and object recognition. Oral steroids upon d/c.  All lab work normal. LP WNL except for elevated glucose. All titers neg.   Discharge to home. Planned optho follow-up.  Continuous improvement over time. Last eye exam showed refractive error-myopia, astigmatism. Also documented  were obesity and pre-hypertension concerns. Nutritional/dietary consult.  ED visit on 2/25/08 also noted for bilat wheeze, cough, post nasal drip and nasal itching. Exacerbation of childhood asthma.				Y	Y	4	Y		U	11/14/2008	12/04/2008	20	Labs and Diagnostics:  MRI (+) optic neuritis.  CSF with 10 WBCs, glucose 111, normal protein 28. CSF cx (-). 1,25-OH vit D (H) 75. Labs & Diags: CSF glucose 111 (H), T bili 0.1 (L), MRI Brain - Appearance of optic neuritis involving the proximal aspect of the optic nerves extending to the chiasm.  CT Head/brain- Incidentally noted 5mm widening of L vestibular aqueduct, otherwise normal. CXR WNL.  CMV neg. Lyme neg. Bergdorfori neg.	MIL	MIL		NONE	ASTHMA, epistaxis. NKDA, eczema, family h/o CA. Allergies: dust, pollens			1						1	Blindness; Optic neuritis; Blindness; Gait disturbance; Headache; Optic neuritis; Photosensitivity reaction; Vision blurred	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~4~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Hospitalisation	Influenza
0340892	03/02/2009	TX	63.0	63		M	03/02/2009	64 yr old male presents with c/o having a flu and pneumonia injections 2 weeks ago and now has soreness, redness, and skin  peeling. He states that originally the red was approx 8 1/2 inches from top area to bottom area. The area was tender to touch and his temp got up to 102. A. Pt has hardness approx 3cm in diameter that is lt pink with darker pink in middle.  No peeling visible now. P. Pt instructed to take Motrin or Tylenol for the pain and inflammation.									Y	10/29/2008	11/09/2008	11		MIL	MIL						1						1	Body temperature increased; Injection site erythema; Injection site induration; Injection site pain; Injection site warmth; Skin exfoliation; Body temperature increased; Erythema; Induration; Inflammation; Pain; Skin discolouration; Skin exfoliation; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89297~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~09798~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89297~5~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~09798~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0340897	03/02/2009	MD	11.0	11		F	02/27/2009	Initial report received on 17 February 2009 from another manufacturer as part of a study for which sanofi pasteur is not a sponsor. The following is verbatim per the report: She is an 11-year-old female who presented to the urgent care clinic for worsening of left knee pain. Patient states that on November 13, Thursday night, she suffered trauma to her left knee/leg while wrestling with her brother. The following morning, she went to school, and was sent home with a temperature of 101. Patient was limping slightly. On November 15, Saturday morning, the patient presented to the ED with a fever of 104.7. In the ED, the patient received a lumbar puncture for concerns of meningitis. Patient was complaining of headache, nausea and dizziness. Patient was sent home from ED on Motrin, and encouraged p.o. intake. Patient continued to have left knee pain to the point she could not bear weight on it. She continued to have fevers, and came back to the ED on Sunday. The patient was examined, evaluated, and discharged home again. Patient continued to have symptoms that progressed overnight. Patient came to the urgent care clinic for worsening of left knee pain. The pain was sharp, located to bilateral joint line, tender to touch. It was 10 out of 10, nonradiating. It is worse with movement, worse on passive flexion and extension. Some relief has bee noted with application of [rest, ice, compression and elevation] (RICE). Mom states the left knee was swollen, warm to touch, and tender. In the urgent care clinic, patient was evaluated. Plain films were taken, and it was decided that the patient, for persistence of fevers x5 days and severe left knee pain, was concerns for septic arthritis. The subject was hospitalized from November 17 to November 26, 2008. Subject had methicillin resistant S. aureus bacteremia and osteomyelitis of her distal left femur. She underwent incision and drainage of her osteomyelitis in the left distal femur. She had a PIC line placed in the right arm for home antibiotic therapy which consisted of clindamycin 600 mg every 8 hours and gentamicin 340 mg every 24 hours. Subsequently because of rising creatinine levels, gentamicin was stopped and rifampin 300 mg twice a day was begun. The subject denied knee pain, fever or other complaints on her last follow-up visit on January 7, 2009. Her incision had healed well, she had normal range of motion of the left knee, CPR was undetectable and her sedimentation rate was 17. The subject had no past medical history and had not been taking any concomitant medications. The final diagnosis was determined to have been Methicillin resistant S. aureus osteomyelitis with bacteremia. The patient (ID number 1-08-03283) had received FLUZONE on 14 October 2008. The date of the SAE was reported as 17 November 2008. The event was considered by the investigator to be serious and unexpected, and not related to either FLUMIST or FLUZONE. The reporter for this case is the same as in case number 2009-00623.					Y	10			Y	10/14/2008	11/17/2008	34	15/Nov/2008: Lumbar puncture; CPR undetectable; Sed rate (17); Gentamicin therapy was stopped due to subsequent rising creatinine levels.	UNK	UNK			The patient suffered trauma to her left knee/leg while wrestling with her brother on the evening of 13 November 2008.		200900622	1						1	Arthralgia; Bacteraemia; Blood creatinine increased; Body temperature increased; C-reactive protein normal; Dizziness; Gait disturbance; Headache; Incisional drainage; Joint swelling; Lumbar puncture; Nausea; Osteomyelitis; Pyrexia; Red blood cell sedimentation rate increased; Skin warm; Staphylococcal infection; Tenderness; Weight bearing difficulty; Arthralgia; Blood creatinine increased; Body temperature increased; C-reactive protein normal; Dizziness; Gait disturbance; Headache; Incisional drainage; Joint injury; Joint swelling; Limb injury; Lumbar puncture; Nausea; Osteomyelitis; Pain; Pyrexia; Red blood cell sedimentation rate normal; Skin warm; Staphylococcal bacteraemia; Tenderness; Weight bearing difficulty	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0340899	03/02/2009	MD	10.0	10		F	02/27/2009	Initial report received on 17 February 2009 from another manufacturer as part of a study for which Sanofi Pasteur is not a sponsor. The patient is a 10 year old female patient in the fifth grade. She reports having lots of trouble controlling her temper. She was arguing with her mother and grandmother and did not believe them when they said that they couldn't go to church because their ride was sick and could not drive them and so the patient threw a fit, barricaded herself in her room and broke a lot of mirrors and windows. The patient also hit her grandmother repeatedly and scratched her mother drawing blood. They report that the patient has been having fits and tantrums every week and it has been escalating. The patient has been hitting walls, getting very argumentative, they do report that the patient gets bullied a lot at school and she is made fun of because of how she looks and pushed into walls. As a result, the patient has tried to have friendship with teachers. She used to be on the honor roll, but she is failing all the classes this year. They report that ADHD is improved on CONCERTA, but again her school performance has worsened quite a bit. The patient lives with her mother and 6 year old brother. The patient's parents divorced when the patient was 6 and then the mother remarried and just divorced the step dad year ago, the patient apparently is very resentful about this and blames her mother and says that she should remarry any guy. They do report that the stepfather was very strict and punished the patient with a belt leaving red marks, but no bruises and the patient was never sexually abused. The patient was admitted to a child psychiatry unit from November 12 to November 19, 2008. Final diagnosis: Behavioral problems with mood and anxiety disorders. Past medical history included ADHD and asthma. The patient was taking CONCERTA, Clonidine, RISPERDAL and ZOLOFT. The patient had received FLUZONE on 03 October 2008. The date of the SAE was reported as 12 November 2008. The event was considered by the investigator to be serious and unexpected, and not related to either FLUMIST or FLUZONE. The reporter for this case is the same as in case number: 2009-00622.					Y	8			U	10/03/2008	11/12/2008	40	none	OTH	OTH	Concerta; Clonidine; Risperdal; Zoloft		Patient has a history of asthma and ADHD (attention deficit hyperactivity disorder).		200900623	1						1	Abnormal behaviour; Affective disorder; Aggression; Anxiety disorder; Educational problem; Abnormal behaviour; Affective disorder; Aggression; Anxiety disorder; Educational problem	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0340925	03/02/2009	TX	0.5	0	.5	F		Patient died of influenza A on 2/10/09. 3/16/09-preliminary anatomic diagnoses received-Influenza A infection with Staphylococcus aureus superinfection and septic shock. Bilateral hemorrhagic bronchopneumonia. Staphylococcus aureus isolated on postmortem lung culture;antibiotic sensitivity pending. Influenza A virus identified by PCR testing on antemortem tracheal aspirate. Bilateral adrenal hemorrhage Waterhouse-Friderichsen syndrome). Coagulopathy widespread glomerular microthrombi. Congestive organomegaly, lungs, liver, kidneys and spleen.  Admitted 2/10/09.	Y	02/10/2009							N	01/14/2009	02/10/2009	27		PVT	PUB	None	None	None			1						1	Death; Influenza	DTAPIPVHIB~SANOFI PASTEUR~C2903AA~3~IM~RL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~UT2794CA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C83143~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1172X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Results in Death	Influenza
0340926	03/02/2009	MA	40.0	40		F	01/28/2009	Severe headache, chest pain, increased blood pressure, loss of consciousness.				Y	Y	4			Y	10/29/2008	11/13/2008	15		PVT	PVT		None				1						1	Blood pressure increased; Chest pain; Headache; Loss of consciousness	FLU3~SANOFI PASTEUR~U2759AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0340945	03/02/2009	NE	53.0	53		M	09/21/2008	Pt was over 50 yo. and received the FLUMIST vaccine normally. Clinic notified 9/20/08 and advised to watch pt closely next 24 hours. On 9/21/08, pt was contacted and is doing well.									Y	09/20/2008	09/20/2008	0		MIL	MIL		Unknown				1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500551P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0340947	03/02/2009	CA	57.0	57		F	02/24/2009	Immediate and excessive pain continuing for 3 wks;  Followed by prolonged weakness in left arm for past 4 months.									N	10/23/2008	10/23/2008	0	None	PVT	PVT		None	None			1						1	Immediate post-injection reaction; Injection site pain; Muscular weakness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA181AA~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0340948	03/02/2009	MA	10.0	10		F	02/10/2009	Left arm-2cm area of erythema and firmness. Tender to touch. Treatment, cold compress.									Y	02/03/2009	02/04/2009	1		PVT	PUB		None	none known			1						1	Erythema; Induration; Tenderness	FLU3~SANOFI PASTEUR~U2760AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0340949	03/02/2009	WI	48.0	48		F	02/16/2009	Patient presented to Employee Health Clinic and informed the RN that she had an allergic reaction to FLUZONE she had administered through Employee Health on 2/6/09. She presented to ER with c/o increasing SOB. Diagnosis: possible flu vaccine allergy.				Y					Y	02/06/2009	02/06/2009	0		PVT	PVT		none reported	Bee stings			1						1	Dyspnoea	FLU3~SANOFI PASTEUR~U2785AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0340950	03/02/2009	TN	4.0	4		M	02/25/2009	L upper arm just below axillae has warmth, redness, & edema on side & back of arm.				Y					U	02/23/2009	02/24/2009	1		PUB	PUB	None					1						1	Injection site erythema; Injection site oedema; Injection site warmth	DTAP~SANOFI PASTEUR~C2456RA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2848AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~AD4902~4~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1210X~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1277X~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0339093	03/03/2009	CA	17.0	17		F	02/22/2009	Received vaccines in boot camp in March and April 1987. Pedio-Jet guns were used, vaccines were mixed, was done outside, there was no cleaning of gun, injection site was not cleaned. Chronic pneumonia, seizures, pain etc.			Y	Y	Y			Y	N	03/20/1987	03/20/1987	0	Antiphospholipid Syndrome & Lupus anticoagulant	MIL	MIL	MOTRIN; SEPTRA DS; APAP; Codeine; Codeine cough syrup	Swollen infected arm; chronic pneumonia; seizures; pain; etc.	allergic to morphine; penicillin; erythromycin; Tetracycline			1						2	Activities of daily living impaired; Allergy to vaccine; Alopecia; Antiphospholipid syndrome; Arthritis; Asthma; Cell death; Chronic obstructive pulmonary disease; Coagulopathy; Convulsion; Deafness; Dyspnoea; Ear infection; Epilepsy; Hepatitis C virus test; Hypersomnia; Immune system disorder; Impaired driving ability; Impaired work ability; Infertility; Loss of consciousness; Migraine; Obsessive-compulsive disorder; Pneumonia; Post-traumatic stress disorder; Red blood cell sedimentation rate increased; Rheumatoid factor increased; Sinusitis; Sleep apnoea syndrome; Sleep terror; Somnolence; Tooth loss; Vertigo; Visual impairment; Antiphospholipid antibodies; Antiphospholipid syndrome; Convulsion; Pain; Pneumonia	UNK~UNKNOWN MANUFACTURER~~UNK~UN~UN~VACCINE NOT SPECIFIED (NO BRAND NAME)~1|ANTH~UNKNOWN MANUFACTURER~~UNK~UN~UN~ANTHRAX (NO BRAND NAME)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEPAB~UNKNOWN MANUFACTURER~~UNK~UN~GM~HEP A + HEP B (NO BRAND NAME)~2|JEVX~UNKNOWN MANUFACTURER~~UNK~PO~MO~JAPANESE ENCEPHALITIS (NO BRAND NAME)~2|MEN~UNKNOWN MANUFACTURER~~UNK~UN~UN~MENINGOCOCCAL (NO BRAND NAME)~2|MMR~UNKNOWN MANUFACTURER~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~2|OPV~UNKNOWN MANUFACTURER~~UNK~PO~MO~POLIO VIRUS, ORAL (NO BRAND NAME)~2|RAB~UNKNOWN MANUFACTURER~~UNK~UN~UN~RABIES (NO BRAND NAME)~2|SMALL~UNKNOWN MANUFACTURER~~UNK~OT~UN~SMALLPOX (NO BRAND NAME)~2|TTOX~UNKNOWN MANUFACTURER~~UNK~UN~UN~TETANUS TOXOID (NO BRAND NAME)~2|TYP~UNKNOWN MANUFACTURER~~UNK~UN~UN~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~2|VARCEL~UNKNOWN MANUFACTURER~~UNK~UN~UN~VARICELLA (NO BRAND NAME)~2|YF~UNKNOWN MANUFACTURER~~UNK~UN~UN~YELLOW FEVER (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0340971	03/03/2009	CO				U	02/27/2009	Initial report received on 20 February 2009 from a newspaper source. Two children, 2 years and younger, had one of the two doses of vaccine recommended for young children (manufacturer and lot number not reported) and have died of influenza. No further information was provided. List of Documents held by Sender: None.	Y								N				None.	OTH	OTH			None		200900658	1						1	Death; Influenza	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Results in Death	Influenza
0340977	03/03/2009	NC	14.0	14		M	02/27/2009	Initial report received 19 February 2009 from a health care professional. A 14-year-old male patient with a medical history of environmental allergies and acne, had received an intramuscular right deltoid injection of FLUZONE SV 2008-2009, lot number U2762AA on 29 October 2008 and three days later, he developed pain in his legs. The patient was evaluated on an unspecified date by his family physician who diagnosed the patient has having Guillain Barre Syndrome (GBS). The patient had no illness at the time of vaccination and he had been receiving ZYRTEC, tetracycline, multivitamin, TYLENOL (prn), and allergy shots concomitantly. At the time of the report, the patient's recovery status was unknown. No additional information was provided. Documents held by sender: None. 3/6/09-records received-office visit 9/23/08-seen for evaluation upon awakening feeling woozy. Suddenly fainted to the floor and after 20-30 seconds appeared fine. Feels hot and cold expecially when changing positions, felt hot last week. Assessment:vestibular dysfunction. Presented on 11/10/08 after ED visit 2 days prior. DX:Probably mesenteric adenitis. Small amount of tenderness to firm palpation in right lower quadrant. 11/21/08-Parent called stating weakness in legs is getting better. Did not return for additional visits.  3/12/09-records received for ED visit 11/8/08-C/O lower right quadrant pain, aching, loss of appetite, nausea.				Y					U	10/29/2008	11/06/2008	8	Unknown 3/12/09-records received-Labs WNL. CT scan abdomen and pelvis normal.	UNK	UNK	ZYRTEC; TETRACYCLINE; MULTIVITAMIN; TYLENOL; ALLERGY SHOTS		The patient had a past history of environmental allergies and acne.		200900642	1						1	Pain in extremity	FLU3~SANOFI PASTEUR~U2762A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0340978	03/03/2009	AL	48.0	48		M	02/27/2009	Initial information received on 18 February 2009 from a health care professional. A 49 year old male patient received FLUZONE (lot number U2761AA) intramuscularly in the left deltoid in August 2008. Two days post vaccination the patient's two index fingers, whole hand, and arm went dead. He was unable to grasp and complained of numbness and pain. He was seen by a neurologist, details not provided. The patient was not recovered at the time of the report. List of Documents held by Sender: none.				Y					N	08/01/2008	08/03/2008	2	none	OTH	OTH					200900638	1						1	Grip strength decreased; Hypoaesthesia; Pain	FLU3~SANOFI PASTEUR~U2761A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0340979	03/03/2009	OK	29.0	29		F	02/24/2009	30 min after shot- hives, pain shooting down arm and chest, nurse gave me BENADRYL. One week later I was still having hives on my chest after eating and still do, plus I have lost weight. Some foods I can't eat and it has been 4 months since the shot.  3/4/09 MR received from PCP from 10/10/08 to 2/6/09 with DX:  Allergic Reaction to Flu vaccine. Pt initially presented 2 hrs after Flu vax with c/o L upper extremity rash which later spread to the face, neck and the rest of the extremity, (+) pruritis. PE (+) for hives, itching, rash. Tx:  Benadryl IM R deltoid..  Returned 10/28/08 w/ c/o 2 week hx of numbness of the R arm near the Benadryl injection site. Decreased sense of touch R deltoid. Likely due to axillary nerve irritation. Pt reports frequent allergic reactions to foods with subsequent wt loss on 11/28/08. Pt presented again with continued and worsening rash-dusky red, maculopapular on trunk, face extremities c/w hives. Referred to allergist.				Y				Y	N	10/10/2008	10/10/2008	0		PVT	PVT	Birth control pills	None	Child hood food allergies- was treated & outgrew them. PMH:  Allergy to eggs (flu vax OK before 2008). Food allergies as child			1						1	Chest pain; Food intolerance; Pain; Urticaria; Weight decreased	FLU3~SANOFI PASTEUR~U2756AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0340981	03/03/2009	OH	32.0	32		M	02/24/2009	10/28 flu shot @ store. 10/29 flu-like sx: myalgia, sore throat 11/1 pain, tenderness @ site. ER/admit 11/10 - 12/1 abscess L deltoid --> staph aureus.				Y	Y	20			Y	10/28/2008	10/29/2008	1	80 cc tan, thick fluid- gm (+) cocci	OTH	PVT			No chronic illness; no known drug allergies			1						1	Gram stain positive; Influenza like illness; Injection site abscess; Injection site pain; Myalgia; Oropharyngeal pain; Staphylococcal abscess	FLU3~SANOFI PASTEUR~U2839AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0340984	03/03/2009	NY	12.0	12		M	02/26/2009	Crusty and itchy: topical skin reaction site of flu shot. Resolved with hypopigmented round area 12 mm diameter site injection. Not itching. Not sore.									U	12/08/2008	12/10/2008	2		OTH	PVT	SINGULAIR; Albuterol as rescue	Stable asthma	Amoxicillin allergy			1						1	Injection site discolouration; Injection site pruritus; Injection site reaction; Scab	FLU3~SANOFI PASTEUR~U2753AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0340990	03/03/2009	FL	4.0	4		F	02/27/2009	Sudden onset of fever 103.9 with cough, headache, & congestion.									U	10/07/2008	02/26/2009	142		PVT	PVT		None	None			1						1	Cough; Headache; Pyrexia; Upper respiratory tract congestion	FLU3~SANOFI PASTEUR~U2789BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0341015	03/03/2009	CO	5.0	5		F	03/03/2009	1) Extreme anxiety - moody and irritable following flu vaccine - constant meltdowns.  2) Sensory issues regarding things touching her - sometimes unwilling to put on clothes.  3)  Constant urge to urinate and feeling that she has been incontinent.   Parent concerned it is related to thimerosol.   Has happened twice - all 3 problems happened after getting flu vaccine, two years in a row.									N	11/28/2008	11/29/2008	1		UNK	UNK						1						1	Anxiety; Incontinence; Irritability; Micturition urgency; Mood altered; Sensory disturbance; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U2771AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB330AA~1~IM~RA~HEP A (HAVRIX)~1	USA		Influenza
0341017	03/03/2009	ID	7.0	7		F	02/17/2009	A serious spontaneous report of seizures and possible transient ischemic attacks has been received from a parent who is also a nurse concerning a seven-year-old female, subsequent to FLUMIST.  The patient had no medical history and was reported to have been very healthy.  The patient received a varicella vaccine on 27-Dec-2007 on the same date as the first FLUMIST vaccine administration.  On 30-Dec-2007, the patient was asleep and started having seizure activity reported as tonic-clonic movements, she stopped breathing and turned blue.  The episode lasted for approximately 90 seconds.  On 30-March-2008, the patient became unable to speak and had right-sided weakness and numbness.  The mother reported that the numbness resolved within 24 hours.  On 20-Oct-2008, the patient received FLUMIST again.  On 12-Jan-2009, an EKG showed abnormal electrical activity on the left side of the brain.  On 19-Jan-2009, a MRI revealed spots on the brain the could be consistent with TIAs.  The patient was started on OXCARBAZEPINE 300 mg BID for the seizures on 19-Jan-2009.  On 19-Feb-2009, the patient had an echoencephalogram, had a chemistry panel drawn, and a PTT for which results are pending.  The events are ongoing.  The mother stated that she does not think that the seizures nor the TIAs are related to FLUMIST.  The sponsor considered the events of seizures and possible TIAs to be serious (important medical events). Follow-up: Information not yet obtained through case follow-up. If information becomes available a VAERS report will be submitted.									N	12/27/2007	12/30/2007	3	Chemistry, 02/09/09, Pending;  Echoencephalogram, 02/09/09, Pending;  EEG, 01/12/09, Abnormal activity on left side of the brain;  MRI Brain, 01/19/09, Spots on brain that could be TIAs;  Prothrombin time, 02/09/09, Pending.	PUB	PUB	Concomitant Drug(s) Not Reported.				MEDI0007972	1						1	Aphasia; Convulsion; Cyanosis; Echoencephalogram; Hemiparesis; Hypoaesthesia; Laboratory test; Nuclear magnetic resonance imaging brain abnormal; Prothrombin time; Respiratory arrest; Tonic clonic movements; Transient ischaemic attack	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~UNKNOWN MANUFACTURER~~UNK~UN~UN~VARICELLA (NO BRAND NAME)~1	USA		Influenza
0341019	03/03/2009	ME	1.0	1	.0	F	03/03/2009	General hives BENADRYL. Observed 90 minutes, hives diminishing. Referred to allergist for testing.				Y					Y	03/03/2009	03/03/2009	0		PVT	PUB			None			1						1	Urticaria	FLU3~SANOFI PASTEUR~UT2792FA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB274AA~1~IM~UN~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~C68311~4~IM~UN~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1777X~1~SC~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0348886	03/03/2009	WI	26.0	26		F	02/11/2009	Reporter contacted manufacturer indicating that the caller had received notification of an AE possible associated with administration of BIOTHRAX vaccine. The subject military service member about to be deployed. The service member was seen at a private physician's office on Fri., 12-19-08 for a small (4mm) red raised lesion on the L forearm. The 26 yr. had received 4th anthrax vaccine in the R deltoid, and Typhoid and Influenza injection in the L deltoid at the military clinic. The physician's major concern was in regards the potential communicability of an anthrax lesion. The reporter had also contacted the DoD and CDC for information and was satisfied that the lesion was not communicable.				Y					U	12/17/2008	12/19/2008	2	Unknown	MIL	OTH	Unknown	Unknown	Unknown		08AV00718SP	1						1	Erythema; Skin lesion	ANTH~EMERGENT BIOSOLUTIONS~Unknown~4~UN~RA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~Unknown~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~Unknown~UNK~UN~LA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0341049	03/04/2009	MO	4.0	4		F	03/02/2009	Initial report received 23 February 2009 from a health care professional. A 4-year-old female patient had received a third dose intramuscular left deltoid injection of FLUZONE 2008-2009, lot number U2809AA on 04 December 2008 at 12:15 hours, and within 10 minutes, the patient experienced a syncopal episode where she became pale, limp and unresponsive with bradycardia and a low respiratory rate. The patient remained unresponsive until EMS arrived at the physician's office. The patient was stimulated with sternal rub and oxygen by mask and taken to the emergency room. She was admitted overnight for observation and released the next day. The patient had no past medical history and had not been taking any concomitant medications. The patient recovered from the event. This patient has two brothers who each experienced a syncopal event post vaccination with FLUZONE which have been captured in case numbers 2008-03955 and 2009-00670. The reporter for this case is the same as for case numbers 2008-03955 and 2009-00670. Documents held by sender: None					Y	2			Y	12/04/2008	12/04/2008	0	Not reported	PVT	PVT			The patient had no past medical history and had not been taking any concomitant medications. The patient has two brothers who each experienced a syncopal event following receipt of FLUZONE.	Syncope~Influenza (Seasonal) (Fluzone)~~8.00~In Sibling|Syncope~Influenza (Seasonal) (Fluzone)~~9.00~In Sibling	200900669	1						1	Bradycardia; Hypotonia; Pallor; Respiratory rate decreased; Syncope; Unresponsive to stimuli	FLU3~SANOFI PASTEUR~U2809A~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0341050	03/04/2009	MO	8.0	8		M	03/02/2009	Initial report received 23 February 2009 from a health care professional. An eight-year-old male patient with no past medical history, had received an injection of FLUZONE 2008-2009, lot number U2758AA on 13 October 2008 and moments after vaccination, he experienced syncope. The event did not require an emergency room visit. The event lasted a few seconds and the patient recovered. This patient has a brother and sister who each experienced a syncopal event post vaccination with FLUZONE which have been captured in case numbers 2008-03955 and 2009-00669. The reporter for this case is the same as for case numbers 2008-03955 and 2009-00669. Documents held by sender: None.				Y					Y	10/13/2008	10/13/2008	0	Not reported	UNK	UNK			The patient had no past medical history. The patient had one brother and one sister who each experienced a syncopal event post FLUZONE vaccination.	Syncope~Influenza (Seasonal) (Fluzone)~UN~9.00~In Sibling|Syncope~Influenza (Seasonal) (Fluzone)~3~4.00~In Sibling	200900670	1						1	Syncope	FLU3~SANOFI PASTEUR~U2758A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0341065	03/04/2009	ME	27.0	27		F	03/04/2009	Patient called and states she has had arm pain since receiving infuenza shot 10/16/2008.  Has seen MD X2.  Was put on NSAIDS TID X 1 week w/ no relief. Is now on steroids.  States pain comes and goes and is a burning feeling.				Y					N	10/16/2008	10/17/2008	1		PUB	PVT						1						1	Burning sensation; Pain in extremity	FLU3~SANOFI PASTEUR~U2751AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0341102	03/04/2009	CA	50.0	50		F	03/04/2009	Initially redness, soreness at injection site - approx 8 hrs later increase HR with some PVC'S, severe HA and backache, low grade fever 99.6 lt headed, body aches - (L) arm redness extending injection site to elbow -10/15/08 - Dx = Severe systemic Rxn to flu vaccine per ID physician told never have another flu vaccine.				Y					Y	10/13/2008	10/13/2008	0	None	PVT	PVT		None	None			1						1	Headache; Heart rate increased; Injection site erythema; Injection site pain; Pain; Pyrexia; Ventricular extrasystoles	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUZ349AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0341107	03/04/2009	CO	53.0	53		F		Swelling in tongue - Labored breathing - BENADRYL				Y					Y	10/30/2007	10/30/2007	0	None	OTH	PVT	Lisinopril 20 mg qd; AMBIEN 10mg pHS	None	High blood pressure; Allergies - penicillin; Cephalosporins; ketones & mocrotides; Busperione; Hydroxyzine hcl			1						1	Dyspnoea; Swollen tongue	FLU3~SANOFI PASTEUR~U2453AA~5~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0341111	03/04/2009	WI	13.0			M	03/04/2009	Mother called 2 days after immunizations listed were given. States child has Hx of eczema rash-mild, but noted some hive-like raised areas on skin over body. No breathing problems. Does itch. No new product use per parent. Mom gave BENADRYL on day 1 + day 2 and stated better when called on Day 2 after shots. Instructed to go to ER if breathing problems.									Y	11/10/2008	11/12/2008	2	None	PVT	UNK		Eczema	Eczema; NKDA			1						1	Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U2828AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2735AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B018BA~6~IM~RA~TDAP (BOOSTRIX)~1	USA		Influenza
0341114	03/04/2009	WI	50.0	50		F	03/03/2009	Pt received flu shot at clinic on 11/3/08. States she started with discomfort to left upper arm from flu shot area to her elbow and states it feels bruised - the pain from (L) shoulder to (L) elbow is exactly in line where shot was given. Saw MD on 12/29 and Xray done; 1/6/09 MRI (L) arm and neck; 2/2 saw MD; 2/13/09 has procedure to deaden nerve; next MD appt 3/16/09.				Y					N	11/03/2008	11/06/2008	3	12/29/08 Xray (L) shoulder; Blood work. MRI (L) shoulder/arm and neck; had a procedure to deaden nerve	OTH	OTH	TYLENOL PM Pr; Calcium; Vitamins; GERITOL; Folic acid; ASA 81mg; LIPITOR; Metaprel; Fenofibrate; Sulfa;	None	D (in SELDANE or CLARITIN-D makes heart flutter); reports cervical spine narrow pathway- not a lot of fluid in my spine. HTN; Increase cholesterol; whiplash history arthritis; cervical disk degeneration; congenital defect			1						1	Blood test; Injection site discomfort; Injection site haematoma; Nuclear magnetic resonance imaging; Pain; X-ray limb	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU380AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0341118	03/04/2009	PA	0.5	0	.5	M	03/04/2009	Child became limp, unable to hold head up, Refused to bear weight on Lower extremities. Awake and alert but out of it according to father. This lasted 10 days, but did not call to inform Pediatrician.									Y	02/16/2009	02/16/2009	0		PVT	PVT						1						1	Abnormal behaviour; Hypotonic-hyporesponsive episode; Weight bearing difficulty	FLU3~SANOFI PASTEUR~U2745AA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF579AA~2~UN~LL~HIB (ACTHIB)~1	USA		Influenza
0341119	03/04/2009	MI	14.0	14		F	03/03/2009	Child rcvd ADACEL, MENACTRA, FLUZONE, Hep A, VARIVAX, and GARDASIL - just after receiving GARDASIL she stiffened up and eyes rolled back, turned pale, teeth clenched according to mom; BP - 119/79 - HR -~70/min- area no urticaria, lungs CTA, No angioedema- episode lasted approx 5 mins - received O2 via IVC (2 liters).									Y	03/03/2009	03/03/2009	0		PVT	UNK		None	None			1						1	Bruxism; Gaze palsy; Immediate post-injection reaction; Musculoskeletal stiffness; Pallor	FLU3~SANOFI PASTEUR~U2839AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB329AA~UNK~IM~RA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~0575~UNK~IM~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~42826CA~UNK~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2773AA~UNK~SC~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~0054Y~UNK~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0341144	03/05/2009	PA	54.0	54		M	03/02/2009	Guillian-Barre Syndrome with loss of sensation in hands/feet and proximal muscle weakness onset on 12/08/08. No improvement as of yet 4 days of IVIG beginning 1/15/09 (Hospitalized).  5/8/09 Received Neuro medical records of 1/12-4/20/2009 which included hospital d/c summary & H&P of 2/16-2/28/09 admit. FINAL DX: acute inflammatory demyelinating polyneuropathy Records reveal patient seen for eval on 1/12/09.  Exam revealed decreased sensation in hands/feet, decreased reflexes.  Seen by second Neuro on 1/15 & 1/28/09 for eval & repeat EMG/NCS which remained abnormal & c/w acute/subacute sensory-motor demyelinating peripheral neuropathy w/significant radicular component.  RTC 3/17/09 improved, started on steroid taper & referred for PT/OT.  RTC 4/15/09 & continued to slowly improve w/excessive tiredness, fatigue, paresthesias of hands/feet & difficulty walking uphill.  Continued PT/OT.  3/18/09 Received hospital medical records of 1/15-1/18/2009. FINAL DX: atypical Guillain-Barre syndrome  Records reveal patient experienced progressive numbness, tingling, pain & weakness of extremities esp hands/feet, difficulty walking, grip strength & dexterity were decreased starting 2 weeks s/p flu shot.  LP done.  Reflexes present but decreased.  Tx w/IVIG & made slight improvement.  Sent to inpatient rehab.  Patient was readmitted for relapse from 2/16/09-2/28/09 FINAL DX: acute GBS s/p vaccination   Patient developed increased difficulty walking, increased muscle weakness, SOB, loss of balance.  Had repeat EMG/NCS done as outpatient which were c/w sensory motor, peripheral neuropathy w/demyelinating features.  Exam revealed near normal muscle strength but DTRs were diminished throughout, sensation was slightly decreased & gait was quite abnormal.  Tx w/plasmapheresis x 7 & steroids. Follow-up: Residual generalized weakness (muscle strength), fatigue, neuropathic pain, and continued paresthesia/numbness feet.				Y	Y	17			N	10/21/2008	12/08/2008	48	Elevated protein in CSF; Demyelinating pattern on NCS/EMG  LABS: EMG/NCS abnormal & c/w acute polyneuropathy.	PVT	PVT	DEPAKOTE; LIPITOR; LEXAPRO	None	Migraines; asthma; osteoarthritis; hyperlipidemia   PMH: IBS, HTN, seizure x 1.  Family hx: seizures, DM, HTN, heart disease, kidney disease, cancer, thyroid disease, migraines & strokes.	Allergic~Influenza (Seasonal) (no brand name)~1~23.00~Patient		1						1	CSF protein increased; Demyelinating polyneuropathy; Electromyogram abnormal; Fatigue; Gait disturbance; Guillain-Barre syndrome; Hypoaesthesia; Immunoglobulin therapy; Muscular weakness; Nerve conduction studies abnormal; Neuralgia; Pain in extremity; Paraesthesia; Peripheral sensorimotor neuropathy; Sensory loss	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89297~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0341146	03/05/2009	AZ	66.0	66		F	03/02/2009	Approximately 4 days after immunization, pt had nausea that went to fever, chills and extreme diarrhea - went to urgent care about 1 1/2 weeks also had dry cough - treated for pneumonia, gave antibiotic abt 3-4 days. Went to Primary care with all the symptoms - placed on BRAT diet for 2-3 days and went to ER. Admitted - rehydrated and found spot? on lung - diarrhea and other symptoms subsided after 2 days in hospital but they kept her to work up lung condition. Possible valley fever.   3/23/09 MR received for DOS 11/21-12/04/2008 with D/C DX:  Interstitial Lung Disease, newly diagnosed.  Pathology c/w but not confirmatory for UIP (Usual Interstitial Pneumonia).  Hypoxemia 2' to interstitial lung disease.  False (+) coccidiomycosis IgM titre.  HTN.  Hyperlipidemia.  Pleauritic Chest Pain.  SOB and cough.  Antibiotic induced diarrhea.  Gastroenteritis.   Pt presented with several week hx of weakness, fatigue, nausea, vomiting, diarrhea and SOB with cough since receiving Flu shot 11/3/08. Recent worsening of SOB with ambulation precipitated ER visit. Initially dx with PNA at urgent care and placed on abx.  No improvement x1 wk on abx. Admitted for complete w/u. PE (+) for rhonchi and rales. Abx changed. Pt continued to desat w/ ambulation. ? Coccidiomycosis so antifungal added with no response. Thoracoscopy done for bx with chest tube placed. When removed, d/c for outpt f/u with O2 supplementation PRN.				Y	Y	14			Y	11/03/2008	11/07/2008	4	Labs and Diagnostics:  CXR (+). CT scan (+) for lung fibrosis/bilateral pneumonitis.  Cocci IgM (+), IgG (-). Mycoplasma (-).  Legionella (-). lung bx c/w interstitial lung disease. CBC with WBCs up to 13.8. H&H down to 9.9 and 28.  Fungal cx lung (-). Lung cx (-).	PUB	PVT	LIPITOR and VESTRAL	None	cholesterol. PMH:  HTN. Hyperlipidemia			1						1	Chills; Cough; Diarrhoea; Nausea; Pneumonia; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~LA158AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation	Influenza
0341150	03/05/2009	VA	1.07	1	.1	M	03/02/2009	See attached. Neurologist's assessment 2/20/09 - normal with coincidental viral infection with fever to 102 on day of visit 2/20/09.				Y					N	02/11/2009	02/12/2009	1	See attached	PVT	PVT		None	None			1						1	Fall; Muscular weakness; Neurological examination normal; Pyrexia; Urticaria; Viral infection	FLU3~SANOFI PASTEUR~UT2787CA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB260AA~1~IM~RA~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~D16279~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1529X~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0341154	03/05/2009	OH	41.0	41		F	02/01/2009	3 days post immunization pt. c/o wheezing with exhalation.  The Monday following 11/10 she came down with flu-like symptoms + fever 101 degrees.  She saw her personal physician given Z Pack.  2 additional episodes in December + January treated with Z-Pack + OTC cold med CXR-negative in February.				Y					N	10/31/2008	11/03/2008	3		OTH	UNK		None reported	None reported			1						1	Chest X-ray normal; Influenza like illness; Pyrexia; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500541P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0341156	03/05/2009	KY	28.0	28		M	02/27/2009	PNEUMOVAX given IM Left deltoid on 2/18/09. On 2/19/09, pt returned to ofc with edema, pain and erythematous streaking from injection site down beneath axilla-streaking completely 1/2 way around his arm.				Y					U	02/18/2009	02/18/2009	0	none	PVT	UNK	none	none	none			1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site streaking	FLU3~SANOFI PASTEUR~V2803AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1163X~1~UN~LA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C3057AA~1~UN~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0341173	03/05/2009	CA	65.0			F	03/05/2009	Patient received flu shot at unknown pharmacy 6 months ago.  Felt immediate pain in Left lateral upper arm, and pain has persisted to the present day.  No loss of motor function.				Y					N					UNK	UNK	HCTZ 25 mg 1 qd; Atenelol 50 mg 1 qd; Simvastatin 40 mg qd	Nothing acute				1						1	Immediate post-injection reaction; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0341175	03/05/2009	NC	1.33	1	.4	U	03/05/2009	localized redness for two days at site of injection. Right thigh.									U	03/03/2009	03/03/2009	0		PUB	PUB		Otitis media and URI				1						1	Injection site erythema	FLU3~SANOFI PASTEUR~UT2797FA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB319AA~1~IM~LL~HEP A (HAVRIX)~1	USA		Influenza
0341177	03/05/2009	CA	3.0	3		M	03/05/2009	multiple wheals around injection site, right shoulder area, and trunks. Hydrocortison cream and Loratadine given.									U	03/03/2009	03/03/2009	0	None	PVT	PUB	None	None	History of reactive airway disease			1						1	Injection site urticaria; Urticaria	FLU3~SANOFI PASTEUR~U2808AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0341201	03/05/2009	CT	57.0	57		M	02/19/2009	Pain, tingling and weakness in legs, feet, arms, hands and face; first noticed numbness in feet end of October, 2008. Progressed to legs, arms, hands and then face. Also progressively got worse and more painful. Diagnosis GUILLAN BARRE.  3/16/09 Neurology consult received with assessment post-vaccinal AIDP (GBS). ROS (+) for difficulty sleeping, blurring of eyes, arthritis, rash, itching, tingling, weakness, numbness.  PE (+) for sensory disturbances toes, ankles and fingers and dysthesias to heels and fingertips. DTRS absent L achilles, depressed tricep, brachiorad, and R achilles. Has had 2 rounds of IVIG with lack of response.  3/31/09 Neuro consults dated 12/2/08 to 3/12/09 received.  Pt presented to neuro with 3 week hx of foot numbness and feeling swollen, tightness in the lower legs and numbness which progressed to the fingertips and hands. PE (+) for absent DTRs in UE and brisk DTRs in LE. Sensory loss in LEs. DX: Acute demyelinating polyneuropathy. 4/14/09 ER note from 12/2/08 received.  Pt sent in by PCP for testing r/t c/o acute numbness to all extremities.  Not seen by MD, only in for testing/spinal tap. Labs as above.				Y					U	10/13/2008	10/29/2008	16	Ultrasound, negative; 2 MRIs; blood work; spinal tap showed elevated protein level; nerve conductivity test. Labs and Diagnostic Studies received:  BUN 20. ANA 1:320-homogeneous. CSF protein 48. CSF WBCs 2-100% monos. CBC WNL. Lyme (-). IgA, IgG, IgM all (-).  EMG/NCS c/w severe acquired demyelinating sensimotor polyradiculopathy. MRI cervical spine (+) for disc disease and unusual appearance to marrow of vertebrae. MRI thoracic spineWNL.	PVT	UNK	none	none	allergic to penicillin. PMH: Osteoarthritis. Hip surgery.  Allergies to PCN & Tetracycline			1						1	Blood test; CSF protein increased; Facial paresis; Guillain-Barre syndrome; Hypoaesthesia; Lumbar puncture; Muscular weakness; Nuclear magnetic resonance imaging; Pain; Paraesthesia; Ultrasound scan normal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLA153BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0341233	03/06/2009	WI	60.0	60		M	01/30/2009	Lightheadedness. Malaise. Chills. Headache. Cough.  3/26/09 Received hospital medical records of 10/7-10/8/2009. FINAL DX: Percutaneous coronary intervention w/stenting Records reveal patient experienced atypical chest pains.				Y	Y	2			Y	10/03/2008	10/04/2008	1	LABS: coronary angiogram abnormal	PVT	PVT			PMH: recent negative cardiac stress test, DM, hypercholesterolemia			1						1	Chills; Cough; Dizziness; Headache; Malaise	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0341238	03/06/2009	MD	16.0	16		M	02/27/2009	Pt got FLUMIST and came down with Influenza A anyway.				Y					Y	11/20/2008	02/23/2009	95	Influenza A positive	MIL	MIL						1						1	Influenza; Influenza serology positive	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0341244	03/06/2009	NJ	15.0	15		F	02/11/2009	Tingling/numbness in left leg, moved up body to left arm, then went to other side of body.  Headache severe.  Heart palpitations.  Cramping in hands, trouble breathing lasted (3-4) days				Y					U	11/05/2008	11/06/2008	1	Emergency room blood gas test & EKG	PVT	PVT						1						1	Blood gases; Dyspnoea; Electrocardiogram; Headache; Hypoaesthesia; Muscle spasms; Palpitations; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89751~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0341250	03/06/2009	WI	70.0	70		F	01/30/2009	Low grade fever, muscle aches, nausea and vomiting.				Y					Y	10/28/2008	10/28/2008	0		PVT	PVT						1						1	Myalgia; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0341251	03/06/2009	WI	7.0	7		M	01/30/2009	Swelling red hot left arm pain Tylenol and ice				Y					Y	11/21/2008	11/23/2008	2		PVT	PVT						1						1	Erythema; Oedema peripheral; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0341282	03/06/2009	PR	35.0	35		M	03/06/2009	UNKNOWN										11/06/2003			HIGH GLUCOSE, HIGH CHOLESTEROL. SHORT RANGE MEMORY RECALL ( NOT TESTED PER PHYSICIAN, YET.)	MIL	OTH	NONE	NONE				1						1	Amnesia; Blood cholesterol increased; Blood glucose increased; Unevaluable event	ANTH~EMERGENT BIOSOLUTIONS~FAV079~2~IM~RA~ANTHRAX (BIOTHRAX)~1|FLUX~UNKNOWN MANUFACTURER~UNKNOW~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~UNKNOW~2~IM~RA~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~UNKNOW~2~IM~RA~HEP A (NO BRAND NAME)~1|SMALL~PFIZER\WYETH~4020074~2~ID~RA~SMALLPOX (DRYVAX)~1|TYP~UNKNOWN MANUFACTURER~UNKNOW~2~PO~MO~TYPHOID LIVE ORAL TY21A (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~UNKNOW~2~IM~RA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA		Influenza
0341284	03/06/2009	CA	32.0	32		F	03/06/2009	The morning after receiving the Tdap, along with a trivalent flu shot, the patient reported jaw pain on the left side that hurt like hell and persisted for several days.									Y	11/21/2008	11/22/2008	1	N/A	UNK	UNK		Migraine headaches controlled on topamax	none			1						1	Pain in jaw	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|TDAP~SANOFI PASTEUR~C3028AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0341298	03/08/2009	KS	20.0	20		M	03/08/2009	Became highly anxious after vaccines given.  Reported tingling in mouth, numbness in feet, and diff. breathing. States couldn't move legs.  Epinephrine inj. given verbalizes relief after 20 min, left area after 30 min.									Y	03/08/2009	03/08/2009	0		OTH	OTH		None	Allergy to PCN			1						1	Anxiety; Dyspnoea; Hypoaesthesia; Mobility decreased; Paraesthesia oral	ANTH~EMERGENT BIOSOLUTIONS~FAD164~UNK~IM~RA~ANTHRAX (BIOTHRAX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89982~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TYP~SANOFI PASTEUR~B0347~UNK~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0341329	03/09/2009	TX				U	03/04/2009	Initial report received 24 February 2009 from another manufacturer (document number 45214091), who received the report from a health care professional.  A patient who was reported to be a health care professional, had received an influenza vaccine (manufacturer, lot number, route and site not reported) in 1998 and an unspecified amount of time later, developed Guillain Barre Syndrome.  No further information was provided at the time of the report.  Documents held by sender: None.				Y									Not reported	UNK	UNK			Not reported		200900746	1						1	Guillain-Barre syndrome	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0341337	03/09/2009	MD	4.0	4		F	02/26/2009	Pt received flu shot and came down with influenza A anyway.				Y					Y	12/31/2008	02/22/2009	53	Influenza A positive	MIL	MIL						1						1	Influenza; Influenza serology positive	FLU3~SANOFI PASTEUR~U2793FA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0341338	03/09/2009	MD	5.0	5		M	02/26/2009	Pt received flu shot and came down with influenza A anyway.				Y					Y	11/20/2008	02/25/2009	97	Influenza A, positive	MIL	MIL						1						1	Influenza; Influenza serology positive	FLU3~SANOFI PASTEUR~U2793FA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0341339	03/09/2009	CA	64.0	64		F	02/23/2009	Shoulders up to neck-soreness still sore-sometimes more than others times- When sick or after other shots vaccines.									N	12/01/2008	12/01/2008	0		PVT	UNK		Soreness shoulders/neck				1						1	Musculoskeletal pain; Neck pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0341345	03/09/2009	CA	16.0	16		F	02/25/2009	Left arm/chest area pain and redness and swelling at site of injection of VARIVAX. Vomited once yesterday morning. Today felt tightness in chest.				Y					U	02/23/2009	02/24/2009	1		PVT	UNK		No	None			1						1	Chest discomfort; Chest pain; Injection site erythema; Injection site swelling; Pain in extremity; Vomiting	FLU3~SANOFI PASTEUR~U2837AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0653X~UNK~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2820AA~UNK~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C3032AA~UNK~IM~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1537X~UNK~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0341349	03/09/2009	SC	8.0	6		F	03/09/2009	Received flu shot on Thursday.  Friday--the vaccine site became red, hot to touch, and hard.  Taken to doctor on Saturday as clinet began having coughing, congestion, and a temp of 99 degrees plus.  Client was given Benadryl and Amoxicillin.  Doctor states client had an allergic reaction to the flu vaccine.				Y					Y	11/13/2008	11/14/2008	1		PUB	PUB		none	none		SC0909	1						1	Allergy to vaccine; Body temperature increased; Cough; Hypersensitivity; Injection site erythema; Injection site induration; Injection site warmth; Respiratory tract congestion	FLU3~SANOFI PASTEUR~U2831AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0341356	03/09/2009	CO	4.0	4		F	03/09/2009	pain, swelling, erythema, itching, significant increase in circumference of upper outer thigh									Y	03/03/2009	03/04/2009	1		PUB	PUB	NONE	NONE	NKDA, NONE			1						1	Injection site erythema; Injection site pain; Injection site pruritus; Injection site swelling	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B084BB~1~IM~RL~DTAP + IPV (KINRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500589P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB330BA~2~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1290x~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1741X~2~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0341363	03/09/2009	CA	23.0	23		F	03/09/2009	Left deltoid area swollen, tender and hot to palpation. Unable to move arm or flexion. Fever upt 10 103.0 by history.									U	03/07/2009	03/07/2009	0	Concurrent with Viral Syndrome	PUB	PUB		Astham, Viral Syndrome	Asthma			1						1	Hypokinesia; Injected limb mobility decreased; Oedema peripheral; Palpitations; Pyrexia; Skin warm; Tenderness	FLU3~SANOFI PASTEUR~1435x~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~A4349111a~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0341372	03/09/2009	IN	2.0	2	.8	F	03/06/2009	Cellulilitis L thigh around vaccine administration site.  Resolved with antibiotics.									Y	02/18/2009	02/19/2009	1	None	PVT	PUB		Tinea corporis	None			1						1	Injection site cellulitis	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B201AA~3~IM~UN~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2828AA~3~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~UNKNOWN MANUFACTURER~UF531AA~3~IM~UN~HIB (NO BRAND NAME)~1|PNC~PFIZER\WYETH~D15650~4~IM~UN~PNEUMO (PREVNAR)~1	USA		Influenza
0341373	03/09/2009	WI	64.0	64		F	03/09/2009	Pt reports she saw Dr for horrible blurred vision...and flashes on the left side of my left eye. Reports she also had increased coughing (forceful) at the time w/Bronchitis-like symptoms. States she saw her internist after Christmas due to continuation of respiratory symptoms (see #18) & headache (L) side of head. MD suggested head MRI - she has not had this yet. Symptoms mainly reports were at the Flu injection site was red and raised --- tender to touch for 2 months tried ADVIL & other pain meds with much relief. Resolved 1 month ago (early February 2009 but is still raspy.				Y					Y	12/03/2008	12/03/2008	0	Did blood work up 5 significant findings. Every test returned as normal.  EKG done.	PUB	OTH	None	sick 3-4 days before got flu shot. Bronchitis like symptoms/ cough/no fever/sinus issues.	None			1						1	Blood test normal; Cough; Electrocardiogram; Headache; Injection site erythema; Injection site pain; Vision blurred; Visual impairment	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA3801AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0341391	03/09/2009	WA	65.0	65		F	10/08/2008	Pt experienced pain, redness and swelling at injection site worsening after 2 days of flu & pneumo injection. TYLENOL for pain.									U	10/06/2008			None	OTH	PVT						1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2802AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0990U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0341418	03/10/2009	NY	8.0	8		F	03/04/2009	Bilateral weakness in legs and urinary difficulty, starting 2 weeks after vaccinations.  Patient was hospitalized, supportive care, symptoms self-resolved.  4/20/09 MR received for DOS 2/13-16/2009 with D/C DX:  Acute infective polyneuritis.  Pt presented several times to PCP with c/o bilateral leg pain and weakness with difficulty urinating.  PE (+) for decreased strength in legs, shotty nodes and tenderness to palpation below the knees. DTRs intact. Concern for GBS. Referred to ER.  Admitted to R/o GBS/Myositis.  Pt developed neck pain 2 days s/p vax then progressed as above.  F/U 2/18/09. Now able to walk on own, no urinary difficulties but still with some pain in feet.				Y	Y	4			Y	01/28/2009	02/12/2009	15	ESR 72 mm/hr. Labs and Diagnostics:  UA WNL. UC (-). CK 70. CRP 0.16. Alk Phos 240. Total protein 9.0. Albumin 5.2.  CBC with WBC 12.5.  ESR initially 72 then down to 16.  Phosphate 5.4 (H). Mg++ 2.1 (H). X-ray lower extremities WNL.	PVT	PUB	None	upper respiratory infection. URI at time of vaccinations	None PMH:  none.			1						1	Dysuria; Muscular weakness; Red blood cell sedimentation rate increased	FLUN3~MEDIMMUNE VACCINES, INC.~500587P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~MERCK & CO. INC.~1369X~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Hospitalisation	Influenza
0341455	03/10/2009	VA	42.0	42		M	03/10/2009	Flu Mist administered as part of annual physical exam caused a severe allergic reaction in right nostril and eye.  Paient started losing vision in right eye (upper visual field) and was diagnosed with Optic Neuritis and brain lesions.  Patient was treated with IV and Oral Steroids at Hospital.  Vision and visual field restored in several days, but brain lesions persist.  Patient diagnosed with post-vaccinial ADEM (Acute Disseminated Encephalomyelitis) and currently working with a nuerologist hospital.  Recent EEG showed damage caused by the Optic Neuritis. 3/19/09 Received Neuro clinic medical records 10/9/08-2/20/2009. FINAL DX: ADEM & optic neuritis s/p vaccination per neurologist.   Records reveal patient experienced optic neuritis, diagnosed at outside facility & seen starting 10/10 for IV steroids x 3 days.				Y					N	09/29/2008	09/30/2008	1	Two MRIs of the brain  - Visual field test - EEG - follow-up with Neurologist scheduled 26 March.  LABS: WBC 21.6(H), neutros 88.3%(H), lymphs 6.5%(L), eos 0%(L).  BUN 27(H).  ALT 62(H), AST 34(H).  CRP 0.020, ESR 12 both(N).  MRI brain abnormal.  Visual evoked potentials abnormal.	MIL	OTH	None	None	None  PMH: condyloma, actinic keratosis, hyperlipidemia, rotator cuff tendonitis.  Family hx: DM			1						1	Acute disseminated encephalomyelitis; Blindness transient; Central nervous system lesion; Electroencephalogram abnormal; Hypersensitivity; Nuclear magnetic resonance imaging brain abnormal; Optic neuritis; Vaccination complication; Visual field tests abnormal	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0341460	03/10/2009	FL	29.0	29		F	03/10/2009	Developed shortness of breath, hives, itching all over approximately 30 minutes after being given PPD, Influenza vaccine, and Tdap.  Sent to ER; received diphenhydramine, epinephrine, atarax, solumedrol and Rx for medrol dose pack, zantac.				Y					Y	01/27/2009	01/27/2009	0		PUB	PVT		none	unknown			1						1	Dyspnoea; Pruritus generalised; Urticaria	FLU3~CSL LIMITED~01949111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|TDAP~SANOFI PASTEUR~C2996AA~UNK~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0341464	03/10/2009	OR	0.6	0	.6	M	03/10/2009	Patient started jerking/seizure for about 1-3 seconds.  Then had about a dozen episode's of the jerking/seizures for about 3-5 seconds.  The patient was taken to the ER and then transfered and was admitted for 3 days.  No other treatment was given.3/16/09-records received for DOS 2/16-2/17/09-DC DX-Movements that are not due to seizures (non-epileptic events). Presented with episodes that occurred day after immunization, bilateral arm abduction with head drop followed by irritability decreased activity for few days. Now back to normal prior to admission. Parents saw vidoes on internet related to infantile spasms and requested admission.					Y	1			Y	02/10/2009	02/11/2009	1	Patient had an EEG and CT scan all results were normal. 3/16/09-records received-EEG normal.	UNK	UNK	None	None	None			1						1	Computerised tomogram normal; Convulsion; Dyskinesia; Electroencephalogram normal	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B192BA~1~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2785AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~SANOFI PASTEUR~UF52AA~1~IM~RL~HEP B (GENHEVAC B)~1|PNC~PFIZER\WYETH~D16281~1~IM~LL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0341469	03/10/2009	HI	33.0	33		M	03/10/2009	Onset of bilateral profound bilateral brachial weakness approx. 6-weeks after having received the split influenza vaccination (injectable).  Vaccine was administered on 8-Jan-2009.  Onset of symptoms approx. 15-Feb-09.  Patient hospitalized on 5-Mar-2009. 3/13/09 MR received for DOS 3/5-xx/2009 (not yet d/c). DX:  Bilateral Brachial Plexopathy.  Pt presented with 3 week hx of bilateral upper extremity sensory and motor loss.  Initially began as R arm muscle pain and progressed.  While running on 2/20/09 pt developed problems breathing which then progressed to R neck, shoulder and arm pain.  later developed BUE weakness and numbness. Markedly decreased exercise tolerance. Admitted to r/o GBS/demyelinating process. 15 lb wt loss in last 2 weeks d/t decreased appetite. Neuro exam (+) for decreased stength 0-2/5 in UEs. UE DTRs absent R, diminished L. Sensory loss bilaerally of UEs.  Resting O2 sat 93%.  Tx with IV steroids with little improvement. Continues with breathing difficulty when supine.					Y	7			N	01/08/2009	02/15/2009	38	20-Feb-09: WBC 10,700; Granulocytes/100 WBC 26.8 (Low); Lymphocytes/100 WBC 60.8 (High); Monocytes/100 WBC 1.2 (High); CK 66 WNL; CK-MB 1.29 WNL; AST-184; ALT-376; Alk Phos 126.       23-Feb-09: RF-neg; AST-243; ALT-468; Alk Phos-137; ANA-Pos (1:160, speckled); Fibrin D-dimer 0.92  Labs and Diagnostics:  CXR (+) for atelectasis.  D-dimer (+). ANA (+).  EMG/NCS (+) for bilateral proximal axonal neuropathy of UEs. PFTs abnormal. MRI brain WNL.  CT C spine (+) for small disc protusionC5-6. MRI of Brachial Plexus (+) for increased signal.  CT chest (+) for hilar lymphadenopathy with nodules noted. Blood gases abnormal. ALT 76-105. CSF glucose 97, otherwise WNL.  CSF cx (-).  HCO3 31. Anion gap (L) 4-6.  CK 36.  CKMB 0.65. Blood glucose 116.	MIL	MIL	Not known	Not known	Not known. PMH:  none			1						1	Alanine aminotransferase increased; Antinuclear antibody positive; Aspartate aminotransferase increased; Blood alkaline phosphatase increased; Blood creatine phosphokinase MB; Blood creatine phosphokinase normal; Fibrin D dimer increased; Granulocytes abnormal; Lymphocyte count increased; Monocyte count increased; Muscular weakness; Rheumatoid factor negative; White blood cell count increased	FLU3~CSL LIMITED~0454911A~6~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Hospitalisation	Influenza
0341481	03/10/2009	NM	57.0	57		F	03/10/2009	Patient was given her first flu shot with Fluvirin on October 29, 2008.  To date she still has muscle tenderness at the injection site.										10/29/2008	10/30/2008	1	None	PVT	PVT	None	None	None			1						1	Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89979~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0341487	03/10/2009	AK	19.0	19		F	03/04/2009	12/8/08 - Rt shoulder tenderness, pain with motion, radiation of pain to wrist/hand - ACE wrap, ice or heat, IBUPROFEN, light duty at work 12/29/08 - worsening pain - ice, PREDINSONE burst 1/8/09 - Ice, IBUPROFEN, avoid painful motions 2/4/09 - Ultrasound - Slightly hypoechoic region apparently within the deltoid muscle. 3/4/09 - NSAIDS, pain medication, physical therapy				Y					N	11/27/2008	12/04/2008	7	Ultrasound - Slightly hypoechoic region apparently within deltoid	PUB	OTH	VALTREX prn	None	None			1						1	Arthralgia; Musculoskeletal pain; Pain in extremity; Tenderness; Ultrasound scan abnormal	FLUX~UNKNOWN MANUFACTURER~UN~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0316500	03/11/2009	IL	19.0			M	01/15/2009	This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), who forwarded the information on 09 January 2009. VAERS reference number 316500. A 19-year-old male patient with no pre-existing medical conditions had received a first dose intramuscular left arm injection of MENACTRA (lot number U2566AA), a first dose intramuscular right arm injection of ADACEL (lot number C2775AA), a first dose intramuscular left arm injection of FLULAVAL (lot number AFFLA050AA), a first dose subcutaneous right arm injection of MMR II (lot number 0868U), and a first dose intramuscular right arm injection of TWINRIX (lot number AHABB103AA). The event began 29 February 2008, 31 days post vaccination. The Follow-up information included medical records for dates of service 03 March - 23 May 2008 which included a discharge diagnosis of Guillain-Barre Syndrome and a secondary diagnosis of: syndrome of inappropriate antidiuretic hormone (SIADH), constipation, right hand 5th metacarpal fracture and depression. The patient presented on 03 March 2008 with a four day history of progressive ascending numbness and motor weakness which began at the ankles, to the upper extremities. Laboratory and diagnostic test results showed CSF - no oligoclonal bands. CSF albumin 49.7. CSF IGG synthesis high at 4.7. CSF protein 79.3. CSF cx (-), otherwise decreased vital capacity and was intubated on 09 March 2008 for seven days, then extubated. The patient had no further respiratory issues and received treatment with intravenous immune globulins (IVIG). The patient then developed inappropriate antidiuretic hormone secretion (SIADH) and was put on fluid restriction. The patient showed some sensation and motor function improvement; however complained of depression and pain in the feet. Neurology noted choriform movements and prescribed CLONAZAPAM, and symptoms resolved. The patient was also noted to have developed bilateral ankle contractures. On 23 May 2008, the patient was discharged and continued with outpatient rehabilitation. The patient's recovery status was unknown at the time of the report. Documents held by sender: None. Follow-up information received on 25 March 2009 from the Centers for Disease Control and Prevention (CDC) (VAERS number 316500). The level of diagnostic certainty for this confirmed GBS case is level 2 using the case definition.					Y	80			U	01/29/2008	02/29/2008	31	CSF - no oligoclonal bands; CSF albumin, 49.7; CSF IGG synthesis, high at 4.7; CSF protein, 79.3; CSF cx, negative, otherwise WNL. CXR, positive for infiltrates in the L perihilar region.	MIL	MIL	BICILLIN	The patient had no illness at the time of vaccination	The patient had no illness at the time of vaccination and no pre-existing medical conditions.  BICILLIN was reported as other medications.		200900082	1						2	Albumin CSF decreased; CSF culture negative; CSF immunoglobulin increased; CSF oligoclonal band absent; CSF protein increased; Chest X-ray abnormal; Constipation; Depression; Endotracheal intubation; Fracture; Guillain-Barre syndrome; Hand fracture; Hypoaesthesia; Inappropriate antidiuretic hormone secretion; Joint contracture; Movement disorder; Muscular weakness; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLA050AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~2|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB103AA~1~IM~RA~HEP A + HEP B (TWINRIX)~2|MMR~MERCK & CO. INC.~0868U~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~2|MNQ~SANOFI PASTEUR~U2566A~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TDAP~SANOFI PASTEUR~C2775A~1~IM~RA~TDAP (ADACEL)~2	USA	Hospitalisation	Influenza
0318648	03/11/2009		20.0			M	02/10/2009	This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), who forwarded the information on 09 January 2009. VAERS reference number 318648. SERIOUSNESS CRITERIA: OTHER- MEDICALLY SIGNIFICANT. A 20-year-old male received an injection of MENACTRA (lot number U2409AA), ADACEL (lot number C2842AA), FLUMIST (MedImmune, lot number 500476P), MMR II (Merck, lot number 0868U), and TWINRIX (GlaxoSmithKline, lot number AHABB103AA) on 18 December 2007. He had no illness at the time of vaccination. Four days after vaccination, on 22 December 2007, the patient began experiencing weakness, paresthesias of the lower extremities, and difficulty walking. He underwent physical therapy, but did not improve, and was subsequently referred to a neurologist. His condition progressed to include weakness and paresthesias of the upper extremities and impaired activities of daily living. Diagnostic testing showed elevated CRP (7.59) and ESR, and EMG/NCV were abnormal in upper and lower extremities. Ct of the C-spine/head and foot x-ray were within normal limits. Genetic testing revealed an abnormality (gene mutation identification test positive). In June 2008 he underwent treatment with intravenous immunoglobulins, and had some improvement. He was medically separated from his occupation, and required a brace on the right foot in order to walk. Final diagnosis as of 07 July 2008 was demyelinating polyneuritis, chronic inflammatory (active). Information received from CDC stated that the patient was diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP). Outcome was not provided. Documents held by sender: None									U	12/18/2007	12/22/2007	4	Diagnostic testing showed elevated CRP (7.59) and ESR, and EMG/NCV were abnormal in upper and lower extremities. CT of the C-spine/head and foot x-ray were within normal limits. Genetic testing revealed an abnormality (gene mutation identification test positive).	UNK	UNK			None reported.		200900086	1						2	Activities of daily living impaired; Asthenia; Blood product transfusion; C-reactive protein increased; Chronic inflammatory demyelinating polyradiculoneuropathy; Computerised tomogram normal; Demyelinating polyneuropathy; Electromyogram abnormal; Gait disturbance; Gene mutation identification test positive; Nerve conduction studies abnormal; Paraesthesia; Red blood cell sedimentation rate increased; X-ray normal	FLUN3~MEDIMMUNE VACCINES, INC.~500476P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~2|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB103AA~UNK~UN~UN~HEP A + HEP B (TWINRIX)~2|MMR~MERCK & CO. INC.~0868U~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~2|MNQ~SANOFI PASTEUR~U2409A~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TDAP~SANOFI PASTEUR~C2842A~UNK~UN~UN~TDAP (ADACEL)~2	USA		Influenza
0327875	03/11/2009	UT	31.0	31		M	01/14/2009	This serious case was reported by a health care professional to the Centers for Disease Control and Prevention (CDC), who forwarded the information on 09 January 2009. VAERS reference number 327875. A 31-year-old male patient, had received a first intramuscular left arm injection of MENACTRA (lot number U2669AA); a tenth intramuscular right arm injection of FLUZONE 2009-2009 (lot number U2750AA); a first subcutaneous left arm injection of YF-VAX vaccine (lot number UF426AA); and a first intradermal right arm injection of ENGERIX B (manufacturer GlaxoSmithKline, lot number AHBVB670AA) on 18 September 2008 at 08:15 am. On 27 October 2007 the CDC received medical records that revealed the patient had pre-existing medical history of lower back disease due to lumbar disk herniation, and a meniscal tear in the left knee times two. The records also revealed, that the patient a had recently traveled abroard with diarrheal illness followed by two to four weeks of finger tip numbness which resolved over the past six weeks. On 29 September 2008, i.e., eleven days after receiving the MENACTRA, FLUZONE, YF-VAX and ENGERIX B, the patient presented to the emergency room with a two day history of worsening ascending lower and upper extremity weakness with abnormal sensation. He also had tightness and tingling of his fingertips, elbow and knee. He was unable to rise from a squat, and had experienced an episode of a fall. The patient was admitted to the hospital and physical examination revealed ascending stocking glove neuropathy with weakness and decreased vibratory sensation in his hands and feet. He had swallowing difficulties as well. The patient was treated with IVIG 2gm/kg (175gm) given over three days (30 September 2008 to 02 October 2008) and IVIG 1gm/kg (90 gm) given over two days (04 October 2008 to 05 October 2008). The CDC received medical records for date of service from 29 September 2009 to 08 October 2008 revealing a diagnosis of GUILLIAN BARRE Syndrome (GBS). Relevant diagnostic tests/laboratory data during hospitalization included cerebrospinal fluid culture that was negative and contained 127 red blood cells (RBC), 2 white blood cells (WBC), and revealed the protein level at 42, and glucose level at 51. An electromyelogram (EMG) on 30 September 2008 was supportive of primary demyelination with mildly prolonged distal and F-wave latencies, borderline velocities in scattered distribution and prolonged blink latencies consistent with GBS. From the medical records the CDC had received on 27 October 2008, the patient had additional diagnostic laboratory values of increased monocytes% to 14.3, and increased phosphorous level of 4.8. A west Nile virus IgG was 0.08, and west Nile virus IgM was 0.02. A Magnetic Resonance Image (MRI) and Magnetic Resonance Angiogram (MRA) were normal. The recovery status of the patient was reported as unknown. documents held by sender: None. 1/28/2010 Last seen in clinic 3/5/09. At that time continued to report fatigue, fine moter deficits, numbness in feet. On exam found to have reduced reflexes and sensations. Expected to continue improvement over the next 12 months with likely no residual deficits.			Y		Y	10			N	09/18/2008	09/27/2008	9	Cerebrospinal fluid culture was negative and contained 127 red blood cells (RBC), 2 white blood cells (WBC), and the protein level was 42, and glucose was 51.  An electromyelogram (EMG) on 30 September 2008 was supportive of primary demyelination with mildly prolonged distal and F-wave latencies, borderline velocities in scattered distribution and prolonged blink latencies consistent with GBS.  From the medical records the CDC had received on 27 October 2008, the patient had additional diagnostic laboratory values that showed the monocytes % increased to 14.3, and phosphorous level increased to 4.8.  A west Nile virus IgG was 0.08, and west Nile virus IgM was 0.02.  A Magnetic Resonance Image (MRI) and Magnetic Resonance Angiogram (MRA) were normal.	UNK	UNK	None		On 27 October 2007 the CDC received medical records that revealed the patient had pre-existing medical history of lower back disease due to lumbar disk herniation, and a meniscal tear in the left knee times two.  The records also revealed, that the patient had recently traveled to South East Asia with diarrheal illness followed by two to four weeks of finger tip numbness which resolved over the past six weeks.		200900084	1						2	Blood phosphorus increased; Blood product transfusion; CSF culture negative; CSF glucose normal; CSF protein normal; CSF white blood cell count negative; Dysphagia; Dysstasia; Electromyogram abnormal; Fall; Fatigue; Fine motor delay; Guillain-Barre syndrome; Hypoaesthesia; Hyporeflexia; Joint stiffness; Monocyte percentage increased; Muscular weakness; Neuropathy peripheral; Nuclear magnetic resonance imaging brain normal; Nuclear magnetic resonance imaging normal; Paraesthesia; Red blood cells CSF positive; Sensory disturbance; Sensory loss; West Nile virus test negative	FLU3~SANOFI PASTEUR~U2750A~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB670AA~1~ID~RA~HEP B (ENGERIX-B)~2|MNQ~SANOFI PASTEUR~U2669A~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|YF~SANOFI PASTEUR~UF426A~1~SC~LA~YELLOW FEVER (YF-VAX)~2	USA	Life Threatening,Hospitalisation	Influenza
0331732	03/11/2009	VA	63.0	63		M	11/09/2008	Patient came from doctor office and says he had severe joint and shoulder pain and cannot move arm at all. The arm was warm to touch, no fever. He was sent to the hospital by his doctor for x-ray and blood work. The x-ray was negative but he blood work came back positive for severe infection. He was given Tramadol and CIPRO for treatment. *Update - 3/11/09. Patient still seeing MD has not recovered. Is seeing Orthopedic doctor.				Y					N	11/06/2008	11/06/2008	0	x-ray and blood work	OTH	PVT	ZOCOR; atenolol; ASTELIN; SINGULAIR; MOBIC	none	no spleen			1						2	Arthralgia; Blood test abnormal; Infection; Injected limb mobility decreased; Musculoskeletal pain; Skin warm; X-ray abnormal; Arthralgia; Infection; Injected limb mobility decreased; Injection site pain; Laboratory test abnormal; Musculoskeletal pain; Skin warm; X-ray normal	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0859U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~2|PPV~MERCK & CO. INC.~0859U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~3	USA	Emergency room visit	Influenza
0335216	03/11/2009	TX	14.0	14		F	12/17/2008	Initial report was received 12 December 2008 from a health care professional.  A 14-year-old female pregnant patient had received a left deltoid injection of MENACTRA, lot number U2683AA, and an injection of GARDASIL (manufacturer Merck), lot number 0381X, and an injection of BOOSTRIX (manufacturer GlaxoSmithKline), lot number AC52B030AA, and FLUMIST (manufacturer MedImmune), lot number 550552P on 05 December 2008 and five days later, she complained of fever 102 degrees Fahrenheit, nausea, vomiting and a stomach ache.  The patient had her last menstrual period on 05 November 2008 and the duration of her pregnancy was reported as approximately eight weeks.  Her medical history, concomitant medication usage and past obstetric history were unknown.  At the time of the report, the patient's recovery status was unknown.				Y					U	12/05/2008	12/10/2008	5	Pregnancy Test: positive	UNK	UNK			The patient's medical and obstetric history were unknown at the time of the report.  Concomitant medication usage was unknown.		200803980	1						2	Abdominal pain upper; Drug exposure during pregnancy; Nausea; Pregnancy test positive; Pyrexia; Vomiting; Abdominal pain upper; Drug exposure during pregnancy; Pregnancy test positive; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~2|HPV4~MERCK & CO. INC.~0381X~UNK~UN~UN~HPV (GARDASIL)~2|MNQ~SANOFI PASTEUR~U2683A~UNK~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B030AA~UNK~UN~UN~TDAP (BOOSTRIX)~2|FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3	USA	Emergency room visit	Influenza
0341514	03/11/2009	FL	55.0	55		F	03/06/2009	Initial information was received on 26 November 2008 from a health care professional in the USA. A 55 year old female patient received a right arm injection of FLUZONE (lot number and route of administration not reported). The date of vaccination was not provided. The patient called the doctor's office to report tingling in and down her right arm since FLUZONE was administered three weeks prior. The patient's recovery status was unknown at the time of the report. No further information is provided. Follow up information was received on 22 December 2008 from a health care professional. On 06 November 2008 the patient received FLUZONE (lot number U2754AA). Immediately following the vaccination the patient experienced tingling down her arm. On 11 December 2008 the patient went to the neurologist who ordered a cervical MRI (Magnetic resonance imaging), EMG/NCV (Electromyography/Nerve Conduction Velocity). The results were not provided. The neurologist believed it was an uncertain relationship to the FLUZONE. No further information was provided. Follow up information was received on 20 January 2009 from a health care professional. The reporter did not have any updates at the time. Follow-up information received on 27 February 2009 from a physician. The patient had undergone outpatient MRI scan of the cervical spine and EMG/NCV analysis since her last neurology visit on 11 December 2008. The Cervical MRI scan revealed significant foraminal disease at C5-6, and the EMG/NCV analysis was normal. The patient was re-evaluated by neurology on 14 January 2009. She had previously received treatment with Naprosyn (start date not provided) and had some relief from her pain. A comprehensive neurological examination was performed that day that revealed reduced cervical lateral range of motion and normal shoulder shrug, strength and tone. There was reduction of sensation in the right C6, but reflexes were symmetrical in all four extremities with flexor plantar responses; and the patient had no cortical release abnormalities. The patient's coordination was intact in the upper and lower extremities with normal mobility in the back. The back had no tenderness and the patient had a negative bilateral straight leg raise (SLR) test. The patient was diagnosed with right cervical radiculopathy secondary to spondylitic disease and was started on a short course of Prednisone 40mg for seven days, then 20mg for five days. After that, she was to resume Naprosyn and return in four weeks for follow-up consideration. Per this new information, this case was upgraded to serious. List of Documents held by Sender: None.				Y					N	11/06/2008	11/06/2008	0	On 11 December 2008 the patient went to the neurologist who ordered a cervical MRI (Magnetic resonance imaging), EMG/NCV (Electromyography/Nerve Conduction Velocity). The cervical MRI scan revealed significant foraminal disease at C5-6, and the EMG/NCV analysis was normal.	PVT	OTH			Not reported.		200803765	1						1	Cervicobrachial syndrome; Electromyogram normal; Immediate post-injection reaction; Joint range of motion decreased; Nerve conduction studies normal; Nuclear magnetic resonance imaging abnormal; Pain; Paraesthesia; Sensory disturbance; Spinal osteoarthritis	FLU3~SANOFI PASTEUR~U2754A~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0341516	03/11/2009	NC	53.0	53		F	03/03/2009	I was told by the hospital that I had no recourse, I worked as a nurse for 1 yr before all of this, volunteered as an instructor.				Y	Y			Y	N	10/28/1998	10/28/1998	0	MRI's	MIL	OTH	PREMARIN 0.625	None	None	swollen arm~Typhoid Vi Polysaccharide (no brand name)~UN~8.00~In Patient		1						1	Nuclear magnetic resonance imaging; Unevaluable event; Activities of daily living impaired; Arthropathy; Balance disorder; Body temperature increased; Decreased appetite; Fall; Feeling hot; Gait disturbance; Memory impairment; Panic reaction; Pyrexia; Sluggishness; Spinal column stenosis; Surgery	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1|HEP~UNKNOWN MANUFACTURER~04374~UNK~UN~UN~HEP B (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0871~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1|TD~UNKNOWN MANUFACTURER~453118~UNK~UN~UN~TETANUS DIPHTHERIA (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEP~UNKNOWN MANUFACTURER~04334~UNK~UN~UN~HEP B (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0871~UNK~UN~UN~PNEUMO (PNEUMOVAX)~2|TD~UNKNOWN MANUFACTURER~453118~UNK~UN~UN~TD ADSORBED (NO BRAND NAME)~2|TYP~SANOFI PASTEUR~~UNK~UN~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~2	USA	Hospitalisation,Disabling	Influenza
0341520	03/11/2009	NJ	25.0	25		M	03/11/2009	26 y/o male ADMS is referred to the FBVHC from WAMC Allergy department for persistent leucopenia since receipt of multiple vaccines. 3/18/09-records received-office visite 3/9/09- C/O tendonitis, plantar warts, carbuncle on plantar surface. Leukopenia after participation in VHC smallpox study in 1/09. No complaints.				Y					U	01/27/2009	02/02/2009	6	COMPLETE BLOOD COUNTS: 2/18/09: WBC 4.0, HGB/HCT 14.1/41.6, PLT 191k; 3/6/09: WBC 3.9, HGB/HCT 13.6/39.9, PLT 135K 3/18/09-records received-Referred for WBC declining to 5.2 neutrophils 1.4, lymphocytes 60.8	MIL	MIL	None	NONE REPORTED	ALLERGIES: +SULFA (HIVES), NO BIRTH/CONGENTIAL DEFECTS, NO CHRONIC MEDICAL CONDITIONS 3/18/09-records received- Allergy to Sulfa-rash.			1						1	Full blood count; Haematocrit normal; Haemoglobin normal; Leukopenia; Platelet count normal; White blood cell count decreased; Carbuncle; Haemoglobin normal; Leukopenia; Lymphocyte count increased; Neutrophil count decreased; Platelet count decreased; Skin papilloma; Tendonitis; White blood cell count decreased	FLUN3~MEDIMMUNE VACCINES, INC.~500583P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB195AB~UNK~IM~UN~HEP A (HAVRIX)~1|SMALL~UNKNOWN MANUFACTURER~~UNK~ID~UN~SMALLPOX (NO BRAND NAME)~1|TYP~SANOFI PASTEUR~B0347~UNK~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500583P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|HEPA~UNKNOWN MANUFACTURER~~UNK~IM~~HEP A (NO BRAND NAME)~2|SMALL~EMERGENT BIOSOLUTIONS~~UNK~ID~~SMALLPOX (ACAM2000)~2|TYP~SANOFI PASTEUR~B0347~UNK~IM~~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~2	USA	Emergency room visit	Influenza
0341545	03/11/2009	NY	13.0	13		M	02/05/2009	Patient received a 3rd dose of varicella vaccine in error.									Y	02/04/2009	02/04/2009	0		PUB	PUB		None	Acne			1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U2840AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1547X~3~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0341557	03/11/2009	ID	22.0	22		F	03/11/2009	Patient vaccinated with Flu vaccine on 10/29/08 and developed syncope on 10/30/09 and passed-out. CT scan of head was negative, probably not a seizure per Emergency Room MD but rather a vasovagal reaction.				Y					Y	10/29/2008	10/30/2008	1	CT scan of head negative, diastolic blood pressure = 40 mmHg.	PUB	PUB	none	none	asthma			1						1	Blood pressure diastolic decreased; Computerised tomogram normal; Loss of consciousness; Presyncope; Syncope	FLU3~SANOFI PASTEUR~42772aa~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0341564	03/11/2009	IL	0.5	0	.5	F	03/11/2009	On 3/7/09, pt developed intermittent fussiness and apparent abdominal pain (legs curling up).  Worsened over next 24 hours, then passed a bloody/mucousy (currant jelly) stool.  Referred to Er, where barium enema did NOT demostrate intussusception; however, symptoms resolved completely at that point and did not return.  Although study did not confirm intussusception, clinical course is very consistent w/ that process, and I suspect the intussusception resolved spontaneously prior to the study. 3/31/09-records received for DOS 3/8/09-presented to ED with C/O abdominal pain times 2 days, bloody stool this morning. Intermittent abdominal pain. DX: Hematochezia, abdominal pain.				Y					Y	02/16/2009	03/07/2009	19	Barium enema - negative for intussusception 3/31/09-records received-Barium enema demonstrated retained feces, no obstruction noted, partial decompression of colon. No intussusception. Stool guacic positive.	UNK	UNK	None	None	None			1						1	Abdominal pain; Barium enema normal; Haematochezia; Irritability; Mucous stools	DTAP~SANOFI PASTEUR~C2999AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2798HA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~VF516AB~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~D33126~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1473X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0341565	03/11/2009	IA	30.0	30		M	03/11/2009	Approximately 7 hours after vaccination on 3/10/09, started feeling febrile (no temperature was taken), chills, sweating, weakness, full body muscle ache, headache, and light-headed.  Sweating and chills resolved by morning, and all other symptoms except for headache resolved by the afternoon of the 11th.									Y	03/10/2009	03/10/2009	0		UNK	UNK	none	no	no			1						1	Asthenia; Chills; Dizziness; Headache; Hyperhidrosis; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~u2799ba~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0341569	03/11/2009	AK	0.5	0	.5	F	03/11/2009	10m 3 wk old had  INTUSSUSCEPTION, had previously had 3 doses of Rotateq at correct schedule, last dose on 10/20/08 10/20/08-office visit-well baby exam. C/O constipation.  4/2/09-records received for DOS 3/9-3/9/09-DC DX:Febrile illness began on 3/6/09, seen in office normal physical exam, thought to have a viral infection. Fever broke and appeared fine. On day of admission woke up very irritable and acting like her stomach hurt, started vomiting, nonbilious. Seen in ED thought to have gastroenteritis. Returned later that afternoon after patient had a stool with bright red color and a second stool deeper red. Stool positive heme.				Y	Y	1			Y	10/20/2008	03/08/2009	139	4/2/09-records received-Unremarkable CMP, normal white count, low hemoglobin 10.5, unremarkable differential. Barium enema releived intussuception. Abdominal x-ray series demonstrates fairly prominent soft tissue density in upper midabdomen could represent changes of intussuception.	UNK	UNK	no	no	no			1						1	Intussusception	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B150AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2786GA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C94097~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0274X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0341575	03/11/2009	CA	46.0	46		F		Non stated.										02/17/2009				PUB	PVT						1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~AFLA178AA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1076X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0331732	03/12/2009	VA	63.0	63		M	03/11/2009	Information has been received from a pharmacy student concerning an approximately 64 year old male patient with allergic reaction to quinolones and alpha blockers who on 09-NOV-2008 was vaccinated with a dose of PNEUMOVAX (lot# not provided) 0.5ml intramuscularly.  There was no concomitant medication.  Subsequently the patient has been experiencing persistent muscle soreness at the injection site.  Patient sought medical attention by calling the pharmacy.  No lab diagnostic studies performed.  At the time of this report the patient had not yet recovered.  Follow-up information has been received from a pharmacist (previously reported as a pharmacy student) who reported that the 63-year-old patient has no spleen.  Patient received the dose of PNEUMOVAX (lot# 657040/0859U) on 06-NOV-2008 (previously reported as 09-NOV-2008) at 14:15.  On 06-NOV-2008 at 16:00, patient went to the doctor's office and said he had severe joint and shoulder pain and could not move arm.  The arm was warm to touch, but the patient did not have a fever.  He was sent to hospital for blood work and x-ray.  X-ray was negative but blood work came back positive for infection.  He was given CIPRO and TRAMADOL as treatment and was referred to an orthopedic doctor.  Patient's recovery was unknown.  Severe joint and shoulder pain, and could not move arm were considered to be disabling.  No further information is available.				Y				Y	U	11/06/2008	11/06/2008	0	Diagnostic laboratory, positive for infection;  X-ray, negative	OTH	PVT	None	Allergic reaction to antibiotics;  Drug hypersensitivity	Splenectomy		WAES0901USA03147	1						3	Arthralgia; Blood test abnormal; Infection; Injected limb mobility decreased; Musculoskeletal pain; Skin warm; X-ray abnormal; Arthralgia; Infection; Injected limb mobility decreased; Injection site pain; Laboratory test abnormal; Musculoskeletal pain; Skin warm; X-ray normal	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0859U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~2|PPV~MERCK & CO. INC.~0859U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~3	USA	Disabling	Influenza
0341571	03/12/2009	IN	26.0	26		F	03/12/2009	Head to toe rash, respiratory distress, elevated temperature, (102 and higher), tachycardia.  Treatment required three trips to the emergency room where patient was given intravenous Benadryl, a selection of steroids, oxygen, antipyretics and supportive care.  4/3/09 MR received for DOS 3/12-15/2009 with D/C DX: Anaphylaxis, likely 2' to influenza and pneumococcal vaccines.  Recurrent wheezing and SOB x 48 hrs. Pt initially presented to ER 3/10/09 with throat swelling and hives. Tx and d/c. Returned with same sx 3/11/09 and tx and d/c. Returned 3/12/09 with recurring sx.  Noted to be acidotic, tachycardic with low Phosphorus and elevated WBCs. Admitted for IV steroids with resolution of hives, rash, SOB, cough, wheezing and throat swelling.				Y	Y	3			U	03/10/2009	03/10/2009	0	Chest radiography, numerous laboratory testing including CBC, ESR. Labs:  WBCs 20K. Bicrb 19. Phosphorus 0.9 up to 2.7. BS up to 113 s/p steroids. CXR WNL. HR 160s.	UNK	UNK		No other illness at the time. Information regarding manufacturer, lot number and other blanks will need to be filled in by administerer of vaccine.	None. PMH: tachycardia. Intersticial cystitis. Smoker	None~ ()~~0.00~Patient|None~ ()~~0.00~Sibling|None~ ()~~0.00~Sibling		1						1	Body temperature increased; Full blood count; Rash generalised; Red blood cell sedimentation rate; Respiratory distress; Tachycardia; Anaphylactic reaction; Body temperature increased; Dysphagia; Dyspnoea; Oxygen saturation decreased; Pharyngeal oedema; Sick sinus syndrome; Tremor; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U2771AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U2771AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0964U~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0341599	03/12/2009	KY	65.0	65		F	03/05/2009	Kidney involvement, nerve inflammation: numbness, tingling, burning, facial and head neuralgia, migraine-like headaches (It began with nerve pain at the sight of the shot) and then accelerated; endocrine system affected, high inflammation level) still under treatment with neurologist. 3/16/09 Received ER medical records of 12/3 & 12/29/2008. FINAL DX: atypical chest pain; palpitations; myalgias; left side tingling Records reveal patient experienced intermittent left groin, left arm, left neck & chest pain when see 12/3 w/onset 3-4 days prior w/positional lightheadedness.  D/C to home w/PCP f/u.  Returned to ER 12/29 w/feeling unwell x 4-6 weeks.  Treated recently for UTI & was on oral antibiotics.  Had intermittent tingling/numbness on left side, fatigue, muscle aches, pins & needles sensation of head.  Exam & labs WNL.  D/C to home w/PCP f/u.   3/19/09 Received PCP medical records of 1/8-1/22/2009. FINAL DX: suspected allergic or autoimmune reaction to experimental anti-aging lotion started 11/08. Records reveal patient experienced persistent symptoms previously seen in ER for on 12/3 & 12/29.  S/S present on 1/8: burning sensation in head, neck & shoulders; facial pain; paresthesias.  Tx w/neuropathic pain meds.  Follow-up: 1. Partial numbness in toes of both feet. 2. Diagnosis of Gastroparesis. 3. Diagnosis of inflammatory neuropathy - peripheral nerve pain. These symptoms have been very debilitating and have greatly altered my quality of life. I had to retire from my position as substitute teacher and curtail my performances as a professional musician. It was necessary to hire someone for gardening and yard work.			Y	Y					N	11/07/2008	11/19/2008	12	Blood Panel/other Blood tests: TSH/Vit. B-12/Vit. D; Brain Scan/MRI; Physical Exam.; Lung X-ray; (Sedimentation Blood test (high)); Diabetes: (negative); EKG; Echo (heart)  LABS:  troponin, chemistry, LFTs, CXR, CT head, echocardiogram & CBC all WNL.  TSH 13.66(H). ESR 32(H).  RA factor 7(N).  ANA neg.  EKG w/left atrial enlargement. 9/08 Labs: TSH, ESRm CT scanm echocardiogram all noted to be WNL.  1/09 TSH elevated, ESR 39(H).  MRI brain abnormal w/multiple areas of chronic & acute ischemic changes.	OTH	PVT	LEVOTHYROXIN 75mg 1Xd;  SIMVASTATIN 20mg 1Xd	None	allergy: penicillin/med. condition: mitral valve prolapse; hypothyroidism  PMH:  Kidney infection.  hyperlipidemia.  shingles x 2.  Atrial fib w/ablation.  cardiac angiogram WNL 1/08.  Family hx: autoimmune disorder			1						1	Blood thyroid stimulating hormone; Burning sensation; Endocrine disorder; Hypoaesthesia; Inflammation; Injection site pain; Migraine; Neuralgia; Renal disorder; Vitamin B12; Vitamin D	FLU3~SANOFI PASTEUR~89985~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0341605	03/12/2009	NC	1.55	1	.5	F	03/03/2009	None. Tdap given instead of DTap # 4 at 18 mos well child check.									U	01/08/2008				OTH	OTH						1						1	Wrong drug administered	FLU3~SANOFI PASTEUR~UT2475AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~0260U~4~IM~UN~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~B701A5B~4~IM~UN~PNEUMO (PREVNAR)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B019AA~1~IM~UN~TDAP (BOOSTRIX)~1	USA		Influenza
0341621	03/12/2009	DC	40.0	40		F	03/12/2009	Patient with difficulty breathing, itching in throat, and hive like reaction to scalp.  Patient never given flu shot in our clinic but reported having it in prior years without problems.				Y					Y	03/03/2009	03/03/2009	0	CXR- NEGATIVE	UNK	UNK	None	Bronchitis and Asthma	None known.  No food allergies known.			1						1	Chest X-ray normal; Dyspnoea; No reaction on previous exposure to drug; Throat irritation; Urticaria	FLU3~SANOFI PASTEUR~U2847AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0341694	03/12/2009	NM	1.2	1	.2	F	02/18/2009	Information has been received from a consumer concerning her 14 month old niece, with no medical history and no allergies, who on 10-DEC-2007 was vaccinated with a dose of PREVNAR (manufacturer unknown).  Concomitant suspect vaccination included PEDVAXHIB.  Other concomitant vaccine included a dose of FLUZONE (unspecified).  Two vaccines were administered in the right thigh region, and the third was administered on her left thigh.  It was reported that, on 10-DEC-2007, When the nurse administered the vaccine, the needle went through her leg and out the other side.  The area swelled up twice the normal size.  The patient was unable to walk for two days.  The patient also experienced a fever and was crying all evening and night.  At the time of the report the patient was recovering.  It was noted that the patient was checked at a clinic.  There were no laboratory of diagnostic tests performed.  No product quality complaint was involved.  No other information was provided.  Follow-up information was reported by a nurse who stated that the patient received PEDVAXHIB and the needle went through the other side.  Additional follow-up information was received from a physician and a Medical Assistant who clarified that the patient never received PREVNAR (manufacturer unknown) or PEDVAXHIB.  It was reported that on 10-DEC-2007, the patient received the following vaccinations:  PEDVAXHIB, Lot # 657392/1164U, right thigh, concomitant suspect therapy, PREVNAR (manufacturer Wyeth), Lot # 854015C, left thigh and FLUZONE, (manufacturer Sanofi). Lot # U2512AA, right thigh.  The physician stated that the vaccine that was injected by incorrect technique on 10-DEC-2007 was PREVNAR.  The physician stated that the patient had recovered.  Additional information is not expected.				Y					Y	12/10/2007	12/10/2007	0	None	OTH	OTH			None		WAES0712USA04824	1						1	Abasia; Crying; Injection site swelling; Limb injury; Pyrexia; Wrong technique in drug usage process	FLU3~SANOFI PASTEUR~854015C~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~MERCK & CO. INC.~1164U~UNK~UN~UN~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~854015C~UNK~UN~UN~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0341676	03/13/2009	IL	48.0	48		F	03/13/2009	First symptoms was my left arm where flu shot was given, began to be very sore days later. Continued throughout the whole arm and my hand, wrist and fingers. Then my neck started to be stiff and sore. Then my right arm was stiff and sore. This eventually grew to my legs, knees, and angles.  Primary Doctor gave me physical and suggested I see a Rheumatologist. In January after this Dr. took extensive blood work. It was determined I had Auto Immune Disease which will eventually become Rheumatoid Arthritis. Was healthy before October 9th, 2008.  Ankles and left hand still swollen and knee joints are painful.  4/6/09 Received Rheum medical records of 12/17/08-3/29/2009. FINAL DX: undifferentiated connective tissue disease, likely seronegative inflammatory polyarthritis, fibromyalgia syndrome Records reveal patient experienced neck, leg & arm pain since 11/2008.  Neuro consult done 12/17/08 dx w/C5-6 DDD.  Referred to PT & MRI.  Referred to Rheum for fibromyalgia 12/08 & tx w/meds.  Rheum 2nd opinion 1/22/09 for polyarthritis unimproved w/meds revealed active synovitis.  Tx w/steroids & recommended plaquenil although pt declined.    6/9/09 Medical records recieved DOS 12/21/07 to 2/26/09. FINAL DIAGNOSIS: Inflammatory polyarthritis. Post vaccination patient presented with left arm and shoulder pain, neck pain. Hand, thumb, wrist pain, weakness. Knee pain. Sent for rheumatology consult.								Y	N	10/09/2008	10/12/2008	3	LABS: ESR 48(H), CRP 2.1(H), ANA 1:320 homogeneous pattern, RF neg, DS-DNA neg. Serum protein electrophoresis abnormal w/monoclonal IgG Lambda detected.	UNK	OTH	6/9/09 Medical records received DOS 12/21/07 to 2/26/09.  Synthroid, Flexeril, Vicodin, plaquinil.	None	6/9/09 Medical records recieved DOS 12/21/07 to 2/26/09. Anemia, c-section, thyroid, PPD(+) placed on INH, pneumonia. Salpingo-oophorectomy.  4/6/09 Records received PMH: hypothyroidism; arthritis, C6-7 DDD; chronic fatigue; joint pain.			1						1	Arthralgia; Autoimmune disorder; Injection site pain; Musculoskeletal stiffness; Neck pain; Pain in extremity; Swelling	FLU3~SANOFI PASTEUR~U2772AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0341730	03/13/2009	CO	1.25	1	.3	M	03/13/2009	Mother reports the following: Child had normal behavior throughout day until approximately 7 hours post vaccination, (7 PM) the child became lethargic and spiked a fever and started shivering.  Acetaminophen was administered at 8:15 PM.  Parents became worried and took child to the local ER for evaluation.  There he was observed and given Prednisilone 4ml (15mg/5ml) po.  In addition the child was encouraged to take fluids po.  He was later D/C from ER with diagnosis of probable allergic reaction to influenza vaccine.  Mother of child contacted via phone this date (03/13/09) and she reports that child exhibited no further symptoms and has returned to normal behavior.				Y					Y	03/10/2009	03/10/2009	0	None	PUB	PUB	None	No	Congenital cleft lip and palate			1						1	Allergy to vaccine; Chills; Lethargy; Pyrexia	DTAPIPVHIB~SANOFI PASTEUR~C3199AA~1~IM~RL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~U2768AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~073446~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0341731	03/13/2009	AK	55.0	55		F	03/13/2009	10/31/08 5pm c/o sore right armpit, took ibuprofen 800mg,11/1/08 3pm injection site size of a quarter, fever & chills, temp 101 degree: 11/2/08 injection site size of palm of hand taking ibuprofen q 4 hr; 11/3/08 injection site measured by PHN 18.5cm wide, 15 cm long, temp 98.7; resolved by 11/10/08									Y	10/31/2008	10/31/2008	0		PUB	PUB	NONE	NO	NONE			1						1	Axillary pain; Chills; Injection site swelling; Pyrexia	FLU3~SANOFI PASTEUR~U2807AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1383U~1~SC~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C3027AA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0341733	03/13/2009	IA	1.0	1	.0	F	03/13/2009	DEVELOPED HERPES ZOSTER 5 MONTHS AFTER RECEIVING VARICELLA VACCINE. UNILATERAL VESICULAR RASH FROM MID ABDOMEN ALL THE WAY AROUND TO MID BACK, PAINFUL, PRURITIC. NO PREVIOUS EXPOSURE TO WILD VARICELLA IS KNOWN.									Y	10/01/2008	03/11/2009	161	VIRAL CULTURE PENDING	PVT	PUB	NONE	NONE	NONE			1						1	Herpes zoster; Pain; Rash pruritic; Rash vesicular; Virus culture	FLU3~SANOFI PASTEUR~U2759AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF491AB~4~IM~LL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0811X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0393X~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0341734	03/13/2009	MI	49.0	49		F	03/13/2009	One week after immunization she noticed a raised, red area (slightly bigger than a silver dollar) on her right deltoid. Broke out in little bumps around this area.  Also reports area hot to touch and itched really bad.				Y					Y	02/06/2009	02/13/2009	7		PUB	PVT		None	None known			1						1	Injection site erythema; Injection site pruritus; Injection site rash; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U2768AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB703AA~1~IM~RA~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB275AA~1~IM~LA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0341736	03/13/2009	MI	18.0	18		F	03/13/2009	Pt has experienced pain in R arm continually since receiving vaccine-worsens with exertion of extremity. A divit at injection site 1st appeared about February 1st, 2009.									N	10/09/2008	10/09/2008	0	Evaluated by Pediatrician, referred to and evaluated by dermatologist.	UNK	UNK	Yaz-oral conceptive	None	Migraines; Tonsillar hypertrophy			1						1	Dermatologic examination; Injection site atrophy; Pain in extremity	FLU3~SANOFI PASTEUR~U2744AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0341737	03/13/2009	NC	50.0	50		F	03/13/2009	terrible back, neck shoulder and head pain, Headache, and disorientation, could not concentrate, malaise, weakness, tired. Went to my family doctor who is monitoring my symptoms.				Y					U	03/10/2009	03/11/2009	1	Blood work done and showed that I had a lowWBC. I had been totally healthy before I was asked o take the flu shot at work this past TUesday. I did not want to take the flu shot because I had had a bad reaction 15 years ago to a flu shot and i had not taken one since.But my job site told us that we had to take the flu shot this week (because we had several cases at work)or we had to go home with out pay.	UNK	UNK		none what so ever	none			1						1	Asthenia; Back pain; Blood test abnormal; Disorientation; Disturbance in attention; Fatigue; Headache; Malaise; Musculoskeletal pain; Neck pain; White blood cell count decreased	FLU3~SANOFI PASTEUR~u2744aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0341742	03/13/2009	VA	3.0			M	03/13/2009	Difficulty with balance within an hour of vaccine. Fever 103 began that night, lasted several days. Child had episodes of twitching during fever. Child was difficult to keep awake for 2 days. Significantly decreased appetite for 1 month.														PVT	UNK		None	None			1						1	Balance disorder; Decreased appetite; Muscle twitching; Pyrexia; Somnolence	FLUX~UNKNOWN MANUFACTURER~~2~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0341758	03/13/2009	CA	1.44	1	.4	F	03/13/2009	Localized redness, swelling at site of DTaP injection.									Y	03/04/2009	03/05/2009	1	None	PUB	PUB	None	None	None			1						1	Injection site erythema; Injection site swelling	DTAP~SANOFI PASTEUR~c299aa~UNK~UN~UN~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2794BA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~D16280~3~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0341769	03/13/2009	IA	22.0	22		F	03/12/2009	Lt arm swollen, hives (Lt arm), Lt arm red, hot swollen pain in Lt arm no fever, no problems breathing. Will given Benadryl 3-6-09 (per doctor direction) noted hives 3-5-09 in afternoon. Arm was already painful @ that time. Still has some soreness in arm 3-13-09. Takes Ibuprofen for soreness.				Y					Y	03/04/2009	03/05/2009	1		PUB	UNK	Ortho Tricyclen	No	Allergy to pertussis vaccine - Born w/out  spleen	crying, red~Pertussis (no brand name)~UN~0.00~Patient		1						1	Erythema; Oedema peripheral; Pain in extremity; Skin warm; Urticaria	FLU3~SANOFI PASTEUR~U2802AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1021X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~U2024AA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0341773	03/13/2009	NJ	4.0	4		M	03/12/2009	Approximately 10 minutes following injections, pruritis and urticarial rash developed.  Rx BENADRYL liquid 1 tsp.									Y	03/12/2009	03/12/2009	0		PUB	PUB		None	Mother states fish & peanut allergies	04/10/2008~Varicella (Varivax)~2~3.00~Patient		1						1	Pruritus; Urticaria	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC21B167AA~5~IM~RA~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~U2768AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1469X~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0341788	03/16/2009	CO				F	03/12/2009	Initial report received from another manufacturer (document number 45214356), who received the report from a health care professional.  A female patient (age not reported) with a history of penicillin allergy, had received an influenza vaccine (manufacturer, lot number, route and site of administration not reported) on an unspecified date in 2004 and an unspecified amount of time later, she developed angioedema and neuropathy.  No further information was provided at the time of the report.  Documents held by sender:  None.				Y					U				Not reported	UNK	UNK			The patient had a history of penicillin allergy.		200900813	1						1	Angioedema; Neuropathy peripheral	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0341793	03/16/2009	PA	84.0	84		M	03/13/2009	Information has been received from a physician concerning an 84 year old male patient with diverticulitis and a history of malaria who on 05-DEC-2008 was vaccinated with ZOSTAVAX (Oka/Merck), 0.65ml. Concomitant therapy included influenza virus vaccine (unspecified), COUMADIN, ECOTIN, LANOXIN and simvastatin (MSD). On 08-DEC-2008 the patient experienced elevate white blood cell count, profuse sweating, decreased appetite and pain between his shoulder blades. The patient noted that the symptoms are similar to the symptoms he experienced when he had a malaria infection. The patient underwent urinalysis (results not reported), chest x-ray (results not reported) and complete blood cell count that revealed an elevated white blood cell count. At the time of report on the 16-DEC-2008 the patient was recovering. The patient sought medical attention seen by the physician. Follow up information has been received from a Physician via medical record concerning an 84 (also reported as 85 year old) year old male patient who on 05-DEC-2008 received a dose of ZOSTAVAX (Oka/Merck) (Lot # 662969/1206X) in the arm at AM. Concomitant therapy included influenza virus vaccine (unspecified), COUMADIN, LANOXIN, simvastatin (MSD), TENORMIN and ECOTRIN. On 05-DEC-2008 the patient experienced fever, sweats, generalized weakness, stomach pain and pain in chest below breasts. On 08-DEC-2008 the patient experienced elevate white blood cell count, profuse sweating, chills, decreased appetite, pain between his shoulder blades and fever. On 15-DEC-2008 complete blood cell count was performed and showed high white blood cell count (20.7 K/micro l), low neutrophils (13%), high blood lymphocyte count (84%), high absolute blood lymphocyte count (17.4%) and many atypical lymphocytes. Also blood culture was performed with no growth in 5 days. On 15-DEC-2008 PA and lateral chest were performed and were compared with multiple chest regress date on 09-OCT-2006. The cardiac silhouette was enlarged, but stable. There were persistent postoperative changes of a right upper lobectomy with volume loss on the right, elevation of the minor fissure and sixth rib resection. There was a stable right fifth rib fracture, which was unchanged in appearance. There was mild scarring in the left lung base. There was no local consolidation, effusion, or pneumothorax. There were degenerative changes of the spine. There were no acute cardiopulmonary process identified and stable postoperative changes of a right upper lobectomy. The patient sought medical attention by the physician. On 06-JAN-2009 patient was recovered. Fever, sweats, generalized weakness, stomach pain, pain in chest below breasts, profuse sweating, decreased appetite, chills and pain between his shoulder blades were considered to be disabling. Additional information is not expected. All available medical records will be provided upon request.				Y				Y	N	12/05/2008	12/05/2008	0	chest x-ray, 12/15/08, No acute cardiopulmonary process identified; absolute neutrophil, 12/15/08, 13% low; lymphocyte count, 12/15/08, many Atypical lymphocyte; lymphocyte count, 12/15/08, 84%, High; urine specific gravity, 12/15/08, 1.020; urinalysis, 12/15/08, Blood negative; urinalysis, 12/15/08, 6.0 unit; urinalysis, 12/15/08, mg/d, Protein trace negative; urinalysis, 12/15/08, mg/d, Ketone trace negative; urinalysis, 12/15/08, Bilirubin moderate negative; blood culture, 12/15/08, No growth in 5 days; serum HDL-C, 12/29/08, 38 mg/d, low; total serum bilirubin, 12/29/08, 1.9 mg/d, high; RDW, 12/29/08, 15.5%, High; prothrombin time, 12/29/08, 16.3 sec, High; hematocrit, 01/19/09, 37.7%, Low; WBC count, 12/15/08, 20.7 K/mi, High; absolute lymphocyte, 12/15/08, 17.4 K/mi, High; tissue PA antigen, 12/15/08, stable postoperative changes of right upper lobectomy; absolute lymphocyte, 12/29/08, 4453 cell, high	PVT	PVT	ECOTRIN; TENORMIN; LANOXIN; ZOCOR; COUMADIN	Diverticulitis	Malaria		WAES0812USA03381	1						1	Abdominal pain upper; Asthenia; Bilirubin urine; Blood bilirubin increased; Blood culture negative; Blood urine absent; Chest X-ray normal; Chest pain; Chills; Decreased appetite; Haematocrit decreased; High density lipoprotein decreased; Hyperhidrosis; Lymphocyte count increased; Lymphocyte percentage increased; Musculoskeletal pain; Neutrophil count decreased; Protein urine absent; Prothrombin time prolonged; Pyrexia; Red cell distribution width increased; Tissue polypeptide antigen; Urine analysis normal; Urine ketone body absent; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~1206X~UNK~UN~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Disabling	Influenza
0341807	03/16/2009	NJ	1.1	1	.1	M	02/19/2009	Developed urticarial lesions on back, face + extremities 5 days after MMR, varicella, Hepatitis A + influenza vaccines were given. Pt had no other symptoms prior to this time.									N	02/13/2009	02/18/2009	5	None	PVT	PUB	None	urticarial lesions 5 days later	None			1						1	Skin lesion; Urticaria	FLU3~SANOFI PASTEUR~UT2792FA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB330CA~1~IM~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1366X~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1380X~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0341818	03/16/2009	PA	18.0	18		M	03/11/2009	Immediately after receiving Hepatitis A, Flu, MMR, MCV4 and Varicella, the patient stated he didn't feel well. His color became pale and he passed out for a few seconds. When he recovered, he said the same thing happened a couple of weeks ago when he gave blood. He laid on the exam table for about 10 min. and stayed in the office for another 30 min. and was fine when he left with his mother and brother.									Y	03/10/2009	03/10/2009	0		PUB	UNK	None	None	None			1						1	Immediate post-injection reaction; Loss of consciousness; Malaise; Pallor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88805~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB262BA~1~IM~RA~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0984K~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|MNQ~SANOFI PASTEUR~U2735AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~1405X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0341839	03/16/2009	KS	57.0	55		F	03/16/2009	Has continued L upper arm pain and numbness down to elbow, cannot raise L arm above 90 degrees. States vaccine caused these symptoms. Has seen her personal physician twice and is currently referred to a shoulder specialist									U	10/17/2008			11. Adverse event onset: unknown when pain and numbness began	PVT	PVT			Unknown			1						1	Hypoaesthesia; Injected limb mobility decreased; Pain in extremity	FLU3~CSL LIMITED~01749111A~3~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0341849	03/16/2009	IN	4.0	4		M	03/16/2009	Mom notified us 48 hours after vaccines that child had had hives and increased temp 101 degrees F - 102 degrees F 24 hrs after vaccine given. Her M. D. prescribed TYLENOL and BENADRYL and s/s resolved. She did bring him here 3-13-09 to look @ L shoulder where KINRIX given - slightly reddened, but WNL, however child pale, lethargic and per mother, problems with balance. Her M. D. was notified my me. His office is closed so he advised child go to ER. Mother said she would take child to ER. Unknown if these s/s were related to vaccines. Mother had also had hives, but she recovered.				Y					Y	03/11/2009	03/12/2009	1	No vaccines and URI- ear and throat virus circulating in our community. Our M. D. local health office also notified.	PUB	PUB			asthma; uses rescue inhaler only			1						1	Balance disorder; Body temperature increased; Injection site erythema; Lethargy; Pallor; Urticaria	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B103BB~4~IM~LA~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~U2800BA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB291CA~1~IM~RA~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0907X~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1325X~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0341850	03/16/2009	CA	54.0	54		F	03/16/2009	Pt C/O redness / itch on L mid arm upon D/C home size 4.5 cm and lump felt about a quarter size, HO notified /seen Pt. and instructed to apply warm pack if posted D/C with increased redness / itch plan to come back to ER.									U	03/14/2009	03/16/2009	2	None Ordered	PUB	OTH			NKDA			1						1	Erythema; Pruritus; Skin mass	FLU3~SANOFI PASTEUR~AFLA3578A~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0341852	03/16/2009	NY	11.0	11		F	03/16/2009	Approx 10 min after immunizations the Pt fainted. No resp. arrest initial V/S BP 109/57 HR 97 RR 24 O2 Sat 98-100% Room Air, monitoring and nutrition provided V/S at discharge 115/59 HR 91 RR 24 Pt alert and oriented x 3.									Y	03/13/2009	03/13/2009	0	CBC; CMP; UA	PUB	PUB	None	None	heart murmur			1						1	Full blood count; Metabolic function test; Syncope; Urine analysis	FLU3~SANOFI PASTEUR~U2839AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB3308A~1~IM~RA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2812AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B033BA~1~IM~LA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1754X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0341864	03/16/2009	MI	11.0	11		F	03/13/2009	Fatigue, joint pain after immunization until 3/08.									Y	11/13/2007	02/13/2008	92	Positive, ANA	PVT	UNK		None				1						1	Antinuclear antibody positive; Arthralgia; Fatigue	FLU3~SANOFI PASTEUR~2523AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0962F~1~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0342125	03/16/2009		12.0	12		F	03/13/2009	Information has been received from a consumer concerning her daughter a 13 year old female who in October 2008, was vaccinated with a third dose of GARDASIL.  There was no concomitant medication.  In December 2008, the patient experienced muscle pain, weakness and joint pain and weakness and the symptoms persisted since to present.  The patient did not sought medical attention.  Additional information has been requested.									N	10/27/2008	12/01/2008	35	None	OTH	OTH	None		None		WAES0902USA04623	1						1	Arthralgia; Asthenia; Myalgia	FLUN3~MEDIMMUNE VACCINES, INC.~500560P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0342645	03/16/2009	NJ	14.0			F	03/13/2009	Information has been received from a consumer concerning her 14 year old daughter who on 26-NOV-2007 was vaccinated with a 0.5 ml dose of GARDASIL. Secondary suspect therapy included Varicella virus vaccine live (manufacturer unknown). Concomitant therapy included influenza virus vaccine (unspecified). The patient sought unspecified medical attention. It was reported that 24 to 36 hours after receiving the vaccine the patient experienced hives and lip swelling. The patient recovered  a couple of days later. Additional information has been requested.				Y					Y	11/26/2007	11/27/2007	1	Unknown	OTH	OTH			Unknown		WAES0902USA00589	1						1	Lip swelling; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~~UNK~UN~UN~HPV (GARDASIL)~1|VARCEL~MERCK & CO. INC.~~UNK~UN~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0333737	03/17/2009	CT	52.0	52		F	12/03/2008	Patient received the flu shot on 10/22/08.  Felt pain at the site.  A few days later pain continued at injection site.  Saw PCP.  Referred to specialist who diagnosed her 10 days later with neuritis.  Had physical therapy.				Y						10/22/2008	10/23/2008	1		PUB	PVT					CT200904	1						2	Injection site pain; Neuritis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88910~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0341571	03/17/2009	IN	26.0	26		F	03/17/2009	3-10-09, 5:30PM CALLED FAMILY MD WITH C/O'S OF SHORTNESS OF BREATH, TEMPERATURE, WHEEZING, HIVES AND SHAKES, MD TOLD PATIENT TO TAKE BENADRYL, BUT SYMPTOMS INCREASED AND SHE WENT TO THE EMERGENCY ROOM.  9:00PM WENT TO ER, GIVEN EPI, BENADRYL, PREDNISONE AND ATIVAN.  SYMPTOMS THE SAME PLUS HEART RATE=168, 02 SATURATION IN HIGH 80'S, SWELLING IN THROAT AND TROUBLE WITH SWALLOWING. AFTER SYMPTOMS DECREASED, PATIENT WAS SENT HOME.  ON 3/11/09, 4:00PM RETURNED TO ER WITH SAME SYMPTOMS, RECEIVED SAME TREATMENT AND WAS RELEASED AROUND 6:00PM. AT 11:00PM ON 3/11/09, WENT BACK TO THE ER WITH SAME SYMPTOMS EXCEPT INCREASING SHORTNESS OF BREATH, 02 SATS ONLY HIGH 80'S.  STAYED IN ER ALL NIGHT AND WAS TO LEAVE IN AM, BUT SYMPTOMS INCREASED AND PATIENT WAS ADMITTED.  FRIDAY, 3/13/09 SYMPTOMS INCREASED AND PATIENT WAS ADMITTED TO HOSPITAL.  PT WAS RELEASED FROM HOSPITAL ON 3/16/09 AND WAS INFORMED SHE HAD SICK SINUS SYNDROME THOUGHT DUE TO ANAPHYLACTIC REACTION FROM VACCINES GIVEN ON 3/10/09. 3/17/09 PATIENT STILL COMPLAINING OF SHORTNESS OF BREATH, FOLLOWING UP WITH MD FOR THIS COMPLAINT.					Y	3			Y	03/10/2009	03/10/2009	0		UNK	UNK						1						2	Body temperature increased; Full blood count; Rash generalised; Red blood cell sedimentation rate; Respiratory distress; Tachycardia; Anaphylactic reaction; Body temperature increased; Dysphagia; Dyspnoea; Oxygen saturation decreased; Pharyngeal oedema; Sick sinus syndrome; Tremor; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U2771AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U2771AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0964U~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0341879	03/17/2009	NJ	64.0	64		M	03/16/2009	Information has been received from a licensed practical nurse, concerning a 64 year old male patient with no known drug reactions/allergies and no pertinent medical history, who on 25-OCT-2008, was vaccinated with PNEUMOVAX (lot # 659150/1384U) 0.5 ml, intramuscularly. Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unknown). The nurse reported that after receiving the vaccine, the patient developed blisters, redness and shedding of skin approximately 4 to 5 cm away from the injection site. The patient sought medical attention and was seen by the physician. At the time of this report, the patient was recovering. Follow-up information received from the licensed practical nurse indicated the he was a 64 year old male patient, weighing 226 pounds and 5' 10'' in height, with no known drug reactions/allergies. The licensed practical nurse stated that the patient called office and came for exam on 27-OCT-2008, complaining of increased injection site redness and blistering. The patient was seen again on 28-OCT-2008 and redness and blisters continued. Detected blisters near bottom of affected area with yellowish drainage using SILVADENE cream. On 30-OCT-2008, the patient was referred to a dermatologist. On 05-NOV-2008, a call was placed to the patient who stated that his arm was improving and did not complain of pain. Redness and blisters were considered to be an other important medical event by the reporter. Additional information is not expected.				Y					N	10/25/2008	10/26/2008	1	None	OTH	OTH			None		WAES0811USA00715	1						1	Injection site erythema; Injection site vesicles; Purulent discharge; Skin exfoliation	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1384U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0341880	03/17/2009		25.0			M	03/16/2009	Information has been received from a registered nurse concerning a 25 year old male with cystic fibrosis and a history of renal transplant and 2 or 3 shoulder muscle removal surgeries who was vaccinated with a dose of PNEUMOVAX (lot # 662662/0979X), intramuscularly. Concomitant therapy included influenza virus vaccine (unspecified). Five days after the vaccination date the patient experienced necrotizing fasciitis. The patient complained of pain at the injection site on his left deltoid. The patient was hospitalized for necrotizing fasciitis and pain at the injection site. He had been in the hospital for 3 weeks. The patient received 2 or 3 surgeries to remove the muscles on his shoulder. The reporter requested a lot check. The patient sought medical attention, he was in the hospital. The patient had not recovered. A lot check has been initiated. Necrotizing fasciitis was considered to be immediately life-threatening, an other important medical event and disabling. Additional information has been requested.			Y	Y	Y	21		Y	N				Unknown	OTH	OTH		Cystic fibrosis	Renal transplant; Shoulder operation		WAES0903USA02039	1						1	Injection site pain; Necrotising fasciitis; Surgery	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0979X~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0341889	03/17/2009	IL	5.0	5		M	03/01/2009	By 11/28 evening upper left arm was red, swollen, itchy. Following day, more swelling, hot to touch, very itchy. 4 a.m. 12/14, severe swelling in knees, wrists, entire left arm huge and hot, hives over whole body, fever, itchy pain. ER, vomiting, dropping blood pressure, swelling and rash whole body. Dx serum sickness. Symptoms lasted 3-4 weeks. 2 days in hospital. Wheezing, swollen lips, trouble walking. A lot of joint pain.  3/20/09 Received PCP medical records of 12/3/08-3/2/2009. FINAL DX: serum sickness, amoxicillin vs vaccines Records reveal patient w/persistent cough & postnasal drip x 3-4 wks when seen 12/3 w/poor sleep secondary to cough.  Initially had URI w/croup, phlegm now dx w/sinusitis & tx w/oral antibiotics.  Exam on 12/12 was well child, had been seen in OT but stopped some time prior, being watched for social lag.  RTC 12/16 s/p hospital admit visit for swelling of lips, knees & wrists.  Tx w/nebs & antihistamines.  Now had tongue tickling, sleepiness, urticarial rash all over, left arm very swollen, purplish, hot, swollen joints.  Followup w/allergist.  Allergy consult 1/9/09. FINAL DX: serum sickness like reaction likely penicillin allergy Suggested patient have FluMist in future.  Continued to have wheezing & tx w/nebs.  Abdominal distension/discomfort was likely due to constipation.  Had trace proteinuria in hospital & UA repeated but not included.  Was to return in 2 wks.  4/10/09 Received hospital medical records of 12/14-12/15/2008. FINAL DX: serum sickness Records reveal patient experineced pruritic erythematous maculopapular lesions and red swollen left arm, bilateral knee pain w/swelling x 2 days.  Tx w/antihistamines, NSAIDs & nebs.  Had orthostatic hypotension w/dizziness & nausea/vomiting in ER & tx w/IVF w/improvement.  D/C to home w/PCP f/u.  Clinic visit 12/29/2008 s/p hospitalization.   FINAL DX: serum sickness like reaction, suspect amoxicillin reaction Doing well w/rare use of NSAID for joint pain, daily zyrtec & intermittent albuterol for coughing.  Meds were discontinued due to improvement & was to continue albuterol as needed.  Felt to be constipated due to recent illness.  UA was to be repeated.				Y	Y	2			Y	12/12/2008	12/13/2008	1	Serum Sickness  LABS:WBC 15.85(H), lymphs 22.0(L), neutros 72.4(H).  ESR 5(N), CRP<0.5(N).  Complement C3(N), C4 15.4(L).  UA w/trace ketones/protein.	PVT	OTH	amoxicillin, Day 10	Cough (lingering) (sinusitis)	none  PMH: recent sinusitis & on amoxicillin at admit.  Hives, viral illness, bronchitis, OM, nosebleeds.  Family hx: eczema, hypothyroidism, GERD, IBS.			1						1	Arthralgia; Blood pressure decreased; Gait disturbance; Injection site erythema; Injection site pruritus; Injection site swelling; Injection site warmth; Joint swelling; Lip swelling; Oedema peripheral; Pain; Pruritus; Pyrexia; Rash generalised; Serum sickness; Skin warm; Swelling; Urticaria; Vomiting; Wheezing	FLU3~SANOFI PASTEUR~U2803AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1119X~3~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1282X~3~SC~RA~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0341893	03/17/2009	CA	5.0	5		M	03/09/2009	No adverse effects observed. Father instructed on after care. Look for fever, soreness in thighs. Possible mild case of flu in next 2 weeks.									Y	03/09/2009			None	MIL	MIL		None	None			1						1		FLU3~SANOFI PASTEUR~U2791DA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0341894	03/17/2009	WA	53.0	53		F		Pt states her Rt arm has been hurting since injection 4 months ago.									N	10/23/2008	10/23/2008	0		PVT	PVT		No	No			1						1	Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA208AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0341897	03/17/2009	NC	35.0			M	03/13/2009	None stated.										03/13/2009				UNK	UNK						1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88907~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0341902	03/17/2009	CA	46.0	46		U		Weakness, Dizziness, Mild Nausea - 20 Mins after injection - feeling (mild) of throat closing VP (Briefly)									Y	02/23/2009	02/23/2009	0	None needed	PVT	PUB		None	None Except new onset HTN			1						1	Asthenia; Dizziness; Nausea; Throat tightness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89124~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0341921	03/17/2009	NH	1.01	1	.0	M	03/17/2009	1 week after patient was given the Flu Shot his right eye showed signs of not moving properly. It looked as if he were going crossed-eye. 24 hours later he threw up for no apparent reason and his eye seemed to be even more crossed. After visiting the Pediatrician's office, Dr. concluded that his right eye was not moving outward to the left and we were sent to Hospital. Patient's eye could move inward and to the center but not outward. Over the next 48 hours movement in his right eye became more constrictive and he started turning his head to the right to see straight forward. Acetazolamide was given after a lumbar puncture showed high amounts of pressure in the fluid in his spine causing pressure on his 6th nerve. He took 125mg per day for a month. Improvements were seen within 24 hours and after 5 days patient appeared to have full moevement back in his eye. Treatment was extended to a month due to the 2nd dose of the flu shot.  His doctor kept him on it for 2 weeks following the 2nd dose. We were not aware at the time that this may have correlated with the flu shot.  3/30/09 Received hospital medical records of 1/2-1/5/2009. FINAL DX: right 6th nerve palsy; right conjunctivitis Records reveal patient experienced x 3 days: left crossed eye; right eye immobile.  Saw PCP who found isolated right abducence nerve palsy & referred to Ophthalmology who confirmed same. Exam revealed facial dysmorphism suggestive of Trisomy 21, right eye serous drainage, left middle ear effusion, lack of right eye abduction, heart murmur.  LP revealed increased ICP (opening pressure 26).  Tx w/Diamox.  Remained stable & d/c to home w/Ophtho, Neuro & Cardio outpatient f/u.    Seen in Neuro clinic 1/13/09 s/p viral gastroenteritic.  Additional testing planned r/t dysmorphism after karyotype WNL.  4/13/09 Received vaccine records & Neuro followup of 2/3/2009.   FINAL DX: post viral right 6th nerve palsy, resolving. Exam revealed lack of right eye abduction.  Diamox decreased.  To return for Neuro & Optho clinic visits in couple of mo.				Y	Y	4			Y	12/11/2008	12/30/2008	19	EKG, Chest X-ray, CT Scan, MRI, Lymes Disease, and Chromosomes were all analyzed and showed normal results. Other blood tests were done as well and all came back normal. A spinal tap or lumbar puncture finally showed high pressure in the spine. Upon releasing pressure, patient's eye showed very slight improvements but returned quickly due to back up fluid pressure in the spine.  LABS:WBC 16.71(H), H/H 9.9/28.4(L), abso lymphs 10.86(H).  Potassium 4.75(H), creatinine 0.1(L).  ESR & CRP WNL.  MRI, MRV, EKG, echocardiogram, CT scan WNL.  CXR abnormal w/asymmetric lung expansion.  CSF: WBC 0, RBC 17, protein 16.8, glucose 57(L), neutros 4%, c/s neg.  Karyotype WNL.	UNK	UNK	Flouride, Poly Vit-Sol (Iron Vitamin)	None	None  PMH: recurrent bilateral AOM.  Left middle ear effusion 12/08.  Left lacrimal duct obstruction.  36 wk preemie, mild neonatal feeding difficulty resolved.			1						1	Blood test normal; Borrelia burgdorferi serology negative; CSF pressure increased; Chest X-ray normal; Chromosome analysis normal; Computerised tomogram normal; Electrocardiogram normal; Eye movement disorder; Lumbar puncture abnormal; Nuclear magnetic resonance imaging normal; Vomiting	FLU3~SANOFI PASTEUR~UT2799FA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C52997~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0341929	03/17/2009	MA	7.0	7		F	03/17/2009	Patient is well appearing and presented to clinic for varicella vaccine. Patient received first varicella vaccine too early (before one years old)and rececived a second varicella on 9-17-07. Patient also presented for flu vaccine. Patient has had flu shot in the past and denies any allergies to eggs or egg products. Patient received 0.5cc flu shot into Right deltoid without incidence. Patient received 0.5cc varicella SC into back left upper arm. Approximately 5 mins after injections patient complained of itchiness in left arm. Left arm injection site redden and had localized swelling approximately the size of a half dollar. Dr. was called to evaluate patient. Patient continued to complain of itchiness, but now spreading to throat and rest of body. Orders for benadryl 25 mg po. after 10 to 15 mis no change. Orders for EpiJr given. Patient transported to hospital via ambulance.				Y					Y	03/13/2009	03/13/2009	0		UNK	UNK		none	PCN			1						1	Immediate post-injection reaction; Injection site erythema; Local swelling; Pruritus; Throat irritation	FLU3~SANOFI PASTEUR~U2829AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1531X~3~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0341934	03/17/2009	IN	24.0	24		M	03/17/2009	Service member was a basic trainee and received multiple vaccines at the end of September 2008 and then developed lower extremity weakness and paresthesias in late October-early November 2008 time-frame. First noted tingling in bilateral great toes which then progressed to calves and thighs. SM was admitted in November 2008 and treated with steroids. He was then discharged to Inpatient Rehab x 8 days with ongoing lower extremity weakness and ataxia. He currently is experiencing ongoing lower extremity weakness and paresthesias. He is pending a medical board. Diagnosed as ADEM. 4/2/09-records received for DOS 11/8-11/17/08- DC DX:Acute transverse myelitis versus ADEM. Ataxia secondary to 1st diagnosis. urinary retention resolving. Received immunizations 3 weeks prior and had 1 week of progressive muscle weakness with mostly lower limb involvement and urinary retention. Began with tingling sensation of big toes progressing to legs buckling and no longer able to walk.Transferred to rehabiliation.  Follow up 5/11/10 Last clinical not visible to VHC-April 2009; last contact with patient, 4/30/09 placed on TDRL status with 70% disability.					Y	10			N	09/29/2008	10/30/2008	31	06 Nov 2008, SERUM, Creatine Kinase, 565 (H*) IU/L; 08 Nov 2008, SERUM, Protein Electrophoresis; Albumin, 4.20 g/dL; Alpha-1-Globulin, .40 (H) g/dL; Alpha-2-Globulin, 0.98 (H) g/dL; Beta-Globulin, 0.94 g/dL; Gamma-Globulin 1.28 g/dL; Albumin/Globulin, 1.2;  Protein, 7.8 g/dL; IFE CANC; Pathologist Review: NO RESTRICTION BAND NOTED; NOV 08: notation in records of LP with elevated myelin basic protein; 11/6/08, L-SPINE, ROUTINE 3-VIEW - IMPRESSION: Mild dextroscoliosis 4/2/09-records received- CSF showed very high myelin basic protein of 353, negative for oligoclonal bands, WBC increased 68, lymphocyte percentage increased 87 and mono percentage decreased 5. . MRI brain negative, MRI of cervical lumbosacral and thoracic spine showed abnormal signal within spinal cord extending from C7 to T2 which indicated tranverse myelitis versus ADEM. Sedimentation rate normal. Chemistries and complete blood count normal. C reative protein 0.06 and Vitamin B12 759.	MIL	MIL	None	None	NKDA, no history of chronic conditions			1						1	Abasia; Albumin globulin ratio normal; Alpha 1 globulin increased; Alpha 2 globulin normal; Ataxia; Beta globulin normal; Blood albumin normal; Blood creatine phosphokinase increased; CSF myelin basic protein increased; CSF oligoclonal band absent; Disability; Electrophoresis protein; Immunoglobulins decreased; Lumbar puncture abnormal; Muscular weakness; Muscular weakness; Nuclear magnetic resonance imaging thoracic abnormal; Paraesthesia; Paraesthesia; Protein total normal; Red blood cell sedimentation rate normal; Spinal X-ray abnormal	FLUN3~MEDIMMUNE VACCINES, INC.~500549P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB251AA~UNK~UN~UN~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0357X~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Hospitalisation	Influenza
0341953	03/17/2009	NC	46.0	46		F	03/17/2009	Patient was given pneumococcal vaccine in L Deltoid on 3/14/09 @ 1722. Patient noted that her arm was very sore. On 3/15/09 @ 2038 RN noted that deltoid areas of arms painful. L deltoid erythematous. Patient's L arm is red, swollen hot and itchy from L deltoid to 2-3 below L elbow. Patient received blood transfusions during the day shift on 3/15/09 through R arm. Applying BENADYL cream to arm for itch. Patient started on rifampin and BACTRIM DS for infection/cellulitis precaution b/c of Hx. of heart valve replacement.									U	03/14/2009	03/15/2009	1		PUB	PVT	DIGOXIN; FOLIC ACID; Levothyroxine; Lorazepam; Morphine; ADVAIR; SPIRIVA; PROTONIX	Anemia; CHF	Promethazine; Mechanical valves: Pulmonic; Tricuspid; Mitral			1						1	Cellulitis; Infection; Injection site erythema; Injection site pain; Injection site pruritus; Injection site swelling; Injection site warmth; Transfusion	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88129~UNK~UN~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1596X~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0342012	03/18/2009		7.0			M	03/18/2009	This case was reported in a literature article and described the occurrence of WELL's syndrome in a 7-year-old male subject who was vaccinated with Hepatitis A (manufacturer unspecified), Varicella and Influenza. The boy presented with a 4-week history of rash and peripheral eosinophilia. He had received the three vaccines (dosages not stated) between 7 and 9 days before developing the rash that initially appeared on the sole of his left foot as a single, raised, pruritic lesion. It subsequently got larger and resembled cellulitis. The boy received oral antibiotics with no effect. The rash progressed to his face and extremities over several days and was pruritic and painful. Lesions varied in appearance and were up to 15cm in diameter; some lesions were flat and target-lesion-like and others were bright red, raised and urticarial. He had low grade fevers as the rash waxed and waned. Laboratory investigations revealed he had an increased WBC count of 23.7 x 109/L, with 59% eosinophils. Lesion biopsy showed eosinophilic cellulitis/WELL's syndrome. His symptoms and peripheral eosinophilia resolved without treatment within 8 weeks of diagnosis and he was asymptomatic at last follow-up. Author stated that the presented case brings to attention a less recognized condition of peripheral eosinophilia and rash that may be associated with immunizations.									Y				Body temperature, low; Eosinophils, 59%; White blood cell count, 23.7x10^9/l	OTH	OTH		Unknown			B0564949A	1						1	Body temperature decreased; Eosinophil percentage increased; Eosinophilic cellulitis; Erythema; Pain; Pyrexia; Rash; Rash pruritic; Urticaria; White blood cell count increased; Biopsy skin; Eosinophil count increased; Eosinophilic cellulitis; Erythema; Pain; Pyrexia; Rash; Rash pruritic; Urticaria; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~UNK~UN~UN~VARICELLA (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~2|VARCEL~UNKNOWN MANUFACTURER~~UNK~UN~UN~VARICELLA (NO BRAND NAME)~2	USA		Influenza
0342045	03/18/2009	TN	13.0	13		F	03/18/2009	Fever, severe abdominal pain; muscle aches, lethargic, has asthma now, also developed skin indentions (tissue break down up underneath the skin) indentions are circular in size, starting around the injection site and has spread throughout entire body; specialist have never seen anything like it; referred for further testing; indentions are not going away but permanently scarring my child, also experiencing vertigo. 3/23/09-records received for DOS 11/10/08-presented with C/O lesions to trunk and extremities- 3/30/09-records received-ED visit 11/2/08-C/O abdominal pain, DX: ruptured ovarian cyst.  Follow-up: (hospitalization, moody, headaches, sweating, vomiting, has developed a rash (skin indentions); attended a wide dermatologist meeting; commented it looks almost like a pox; they've never seen; also referred me; visual looks like an indentation someone might receive from a polio shot; please help; she has over seventy now and spreading.				Y	Y	1			N	10/18/2007	10/18/2007	0	Several biopsies; performed by two dermatologist (specialist); regular dermatologist; plus regular doctor visits; and ultrasound and CAT scan of abdomen 3/23/09-records received-biopsy obtained. two skin graphs and blood work; specialist stated her fibers in her skin are breaking down	PVT	PVT	The doctors office is showing two other shots Td Adult lot#C2775AA its hard to read the form given on 10/17/08; also meningococcal lot#U2426AA also given on 10/18/07; its very hard to read the lot numbers on the form. None; at the time of v	All of the side effects started at the time of the vaccination and the skin indentions started shortly after the first shot; no illnesses at the time vaccination; she developed symptoms; fatigue and fever right after receiving the shot; the other symptoms as well shortly after	None; my daughter was very healthy and athletic; so healthy she wouldn't drink but maybe two soft drinks a year; she is allergic to the fruit formula given before having a CAT scan; we discovered that whe she was hospitalized for severe abdominal going to her side; no pre-existing conditions; purpose of the doc. visit complete physical in order to play volleyball for school; she was very healthy at the time; none of these symptoms; physical was a clean bill of health; after vaccinated she started experiencing all these symptoms; submitted form to your system a couple of days ago but I did not have all the lot numbers and info for the vaccines; this is the second and correct lot number submission			1						1	Abdominal pain; Asthma; Biopsy skin; Computerised tomogram; Lethargy; Myalgia; Pyrexia; Scar; Skin disorder; Ultrasound abdomen; Vertigo; Abdominal pain; Asthma; Biopsy skin; Computerised tomogram; Hyperhidrosis; Lethargy; Myalgia; Ovarian cyst ruptured; Pyrexia; Scar; Skin disorder; Skin lesion; Vertigo	FLUN3~MEDIMMUNE VACCINES, INC.~500487P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~1265U~1~IM~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2426AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2775AA~1~IM~RA~TDAP (ADACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500487P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|HPV4~MERCK & CO. INC.~1265U~1~UN~LA~HPV (GARDASIL)~2|MEN~UNKNOWN MANUFACTURER~~UNK~UN~UN~MENINGOCOCCAL (NO BRAND NAME)~2|TD~SANOFI PASTEUR~C2778AP~UNK~UN~UN~TD ADSORBED (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0342048	03/18/2009	TX	3.0			M	03/06/2009	A serious, spontaneous report of status epilepticus, dehydration and fever was received from a physician, concerning a 36-month-old male subsequent to FLUMIST.  The patient's past medical history includes neuromuscular disorder, cerebral palsy, seizure and microcephaly.  Concomitant medications included anti-epileptic medication.  A week prior to vaccination the patient had a runny nose and congestion.  The patient received FLUMIST on 15-Oct-2008 for vaccination.  On 17-Oct-2008, the patient presented with a fever of 38.1 degrees Celsius.  On 18-Oct-2008 the patient was admitted to the hospital with dehydration and status epilepticus and was intubated.  During routine surveillance of sick children, CDC analysis of samples from this patient revealed Influenza type B, which proved to be FLUMIST type B.  The reporter stated that the events would be reported to VAERS.  The patient recovered on an unknown date.					Y				Y	10/15/2008	10/17/2008	2	Unknown date: Routine sequence analysis: type B influenza virus (FLUMIST strains); NI, NI, NI	OTH	OTH	Concomitant Drug(s) Not Reported	Cerebral palsy; Seizure; Microcephaly	Neuromuscular disorder; Taking anti-epileptic medication		MEDI0008055	1						1	Dehydration; Endotracheal intubation; Influenza; Influenza serology positive; Pyrexia; Status epilepticus	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0342053	03/18/2009	NY	65.0	65		M	03/18/2009	Like usual after vax, jogged for 3 1/2 hours with 2-3lb weights. At 2p had lunch and became nauseous, dizzy and weak so went to sleep. Woke up at 6pm and only ate some dinner because felt physically exhausted and woke up by noon next day. Problems resolved, no recurrence since then. No pain at site of injection or scratchy throat.									Y	10/01/2008	10/01/2008	0		PVT	PVT	Vitamin D; ZINC; calcium chew; vitamin chew	no	possible ulcer; colitis; multiple sclerosis			1						1	Asthenia; Dizziness; Fatigue; Nausea	FLUX~UNKNOWN MANUFACTURER~~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0342057	03/18/2009	NC	40.0	40		U	06/07/2005	Incidental diagnosis of thrombocytopenia during routine physical.  Menorrhagia (excessive menstrual bleeding) Start: 11/15/2004										11/15/2004			Diagnostic Test: pelvic u/s (12/04) mult. leiomata max 2.8cm; endometrial biopsy; Labs: plts(1/02)-271K' plts(10/04)-65K; H/H, CMP; TSH-wnl; EBVIgM-neg; EBVIgG-posl coags-wnl; ANA-1:40 speckled; Fibronigen; d-dimer-wnl;	UNK	UNK	TRI-LEVLEN TRIPHASIC		metromenorrhagia			1						1	Antinuclear antibody positive; Biopsy endometrium normal; Blood fibrinogen; Blood thyroid stimulating hormone normal; Coagulation test normal; Epstein-Barr virus antibody negative; Epstein-Barr virus antibody positive; Fibrin D dimer normal; Haematocrit; Haemoglobin; Mammogram normal; Menorrhagia; Metabolic function test; Ultrasound pelvis; Ultrasound scan abnormal	ANTH~EMERGENT BIOSOLUTIONS~~UNK~SC~UN~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~UNKNOWN MANUFACTURER~~UNK~IM~UN~HEP B (NO BRAND NAME)~1|MNQ~SANOFI PASTEUR~~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TYP~SANOFI PASTEUR~~UNK~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0342978	03/18/2009	TX	4.0	4		F	02/12/2009	A serious, study report of right lower lobe pneumonia was received from an investigator, concerning a four-year-old female subject number 1-08-02946 enrolled in a study. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject had a history of fever and cough for approximately five days prior to hospitalization but was otherwise a healthy patient. She was not taking any concomitant medications. The subject received FLUMIST on 10-Oct-2008. The subject was admitted to the hospital on 18-Nov-2008. On admission, her chest X-ray was consistent with right lower lobe pneumonia. WBC was 13,300 with 63% neutrophils. A blood culture was sterile. She had an uncomplicated hospital course and was discharged on cefdinir twice a day to complete a ten-day course. The subject was seen again on 22-Nov-2008 in the emergency room (ER) for subjective fever and back pain. Physical examination was unremarkable and the subject was not in respiratory distress. Repeat chest x-ray was without significant change. Her rapid flu test was negative. She was sent home on ibuprofen for pain. The subject's final diagnosis was right lower lobe pneumonia. The subject was discharged from the hospital on 19-Nov-2009, but the outcome of the event was not reported. The investigator assessed the event as not related to FLUMIST.					Y	1			U	10/10/2008	11/18/2008	39	22-Nov-2008, Rapid flu test, Negative; Blood culture, 11/??/08, Sterile; Chest X-ray, 11/18/08, Consistent with right lower lobe pneumonia, 11/22/08, No significant change; Neutrophils, 11/??/08, 63%; WBC, 11/??/08, 13,300	OTH	OTH	Concomitant Drug (s) Not Reported		The subject has a history of fever and cough for approximately five days prior to hospitalization on 18-Nov-2008.		MEDI0007935	1						1	Back pain; Blood culture negative; Chest X-ray abnormal; Cough; Influenza serology negative; Lobar pneumonia; Neutrophil percentage increased; Pyrexia; White blood cell count increased	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0342979	03/18/2009	WA	2.8			F	02/19/2009	A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a 34-month-old female who received FLUMIST.  Neither the patient's medical history nor concomitant medications were reported.   The patient received FLUMIST on 19-Feb-2009, which expired on 12-Feb-2009.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.									Y	02/19/2009	02/19/2009	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0008002	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0342980	03/18/2009	OH	2.0	2	.8	F	02/11/2009	A non-serious, spontaneous report of gave expired FLUMIST in a 33-month-old female patient was received from a nurse practitioner. On 11-Feb-2009, the patient received expired FLUMIST.  The office called the parent and explained that the child may no be fully protected;  however, the parents decided no to return to the office for re-dosing.  On 12 Mar 2009, the nurse practitioner confirmed that no adverse event occurred. There was no adverse event associated with this medication error;  therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.  This case is submitted in accordance with agency post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received on 12 Mar 2009 and the following information was added to the narrative: no adverse event occurred.  This is in follow-up to report(s) previously submitted on 02/11/09. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	02/11/2009	02/11/2009	0		PVT	PUB	Concomitant Drug(s) Not Reported		Past Disease:  Ear infection;  Ear tube insertion		MEDI0007971	1						1	Expired drug administered; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~IN500554P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0342981	03/18/2009	OH	4.0	4		M	02/11/2009	A non-serious, spontaneous report of gave expired FLUMIST in a four-year-old male patient was received from a nurse practitioner. The patient's medical history included constipation and ear infections. Concomitant medications included: taking MIRALAX one daily for constipation; coadministration of three other vaccines with FLUMIST (DTAP, POLIO, MMR/Chicken Pox). On 11-Feb-2009, the patient received expired FLUMIST. The office called the parent and explained that the child may not be fully protected; however, the parents decided not to return to the office for re-dosing. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. This is in follow-up to report(s) previously submitted on 02/11/09. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 04/09/2009: Product Complaint Investigation results. 03/12/09 On 12 Mar 2009, the nurse practitioner confirmed that no adverse event occurred. Additional information received on 12-Mar-2009 and added to the narrative. No adverse event occurred.									Y	02/11/2009	02/11/2009	0		PVT	PUB	MIRALAX	Constipation; Ear infection	Tubes in ears due to ear infections		MEDI0007922	1						1	Expired drug administered	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500554P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMRV~UNKNOWN MANUFACTURER~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA + VARICELLA (NO BRAND NAME)~1	USA		Influenza
0342982	03/18/2009	UT				U	02/06/2009	A non-serious spontaneous report of administration of expired product was received from a Registered Nurse concerning a child.  FLUMIST was administered on 24-Jan-2009 and the dose had expired on 18-Dec-2008.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of th eflu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009; product complaint investigation results.									Y	01/24/2009	01/24/2009	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007907	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0342983	03/18/2009	TX	4.0			M	02/05/2009	A non-serious spontaneous report of 29 patients received expired FLUMIST was received from a physician concerning a four-year-old male.  The patient's medical history included no history of asthma.  Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008).  The reporting physician was concerned regarding efficacy and loss of potency due to the expired product.  Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications).  There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error.									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug (s) Not Reported				MEDI0007901	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0342984	03/18/2009	TX	4.0			F	02/05/2009	A non-serious spontaneous report of 29 patients received expired FLUMIST was received from a physician concerning a four-year-old female.  The patient's medical history included no history of asthma.  Concomitant medications were not available.  On 06-JAN-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008).  The reporting physician was concerned regarding efficacy and loss of potency due to the expired product.  Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications).  There were no adverse events associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error.									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug (s) Not Reported				MEDI0007891	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0342985	03/18/2009	TX	3.0			M	02/05/2009	A non-serious spontaneous report of 29 patients received expired FLUMIST was received from a physician concerning a 36-month-old male.  The patient's medical history included no history of asthma.  No concomitant medications were not available.  On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008).  The reporting physician was concerned regarding efficacy and loss of potency due to the expired product.  Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications).  There were no adverse events associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicted population of 2 years to 59 months of age for FLUMIST.  On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. Follow-up information received on 31-Mar-2009 included Product Complaint Investigation results.									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug(s) Not Reported				MEDI0007884	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~550512F~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0342986	03/18/2009	TX	4.0			F	02/05/2009	A non-serious spontaneous report of 29 patients received expired FLUMIST was received from a physician concerning a four-year-old female.  The patient's medical history included no history of asthma.  Concomitant medications were not available.  On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008).  The reporting physician was concerned regarding efficacy and loss of potency due to the expired product.  Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications).  There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  This case is being submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. This is in follow-up to report(s) previously submitted on 02/05/09. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. Additional information was received on 31-Mar-2009 and incorporated into the narrative: product complaint investigation results.									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug(s) Not Reported				MEDI0007881	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0342987	03/18/2009	TX	3.0			F	02/05/2009	A non-serious spontaneous report of 29 patients received expired FLUMIST was received from a physician in the concerning a 36-month-old female.  The patient's medical history included no history of asthma.  Concomitant medications were not available.  On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008).  The reporting physician was concerned regarding efficacy and loss of potency due to the expired product.  Since the facility only administered the immunizations and dose not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to included all their concomitant medications).  There were no adverse events associated with these medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  This case is being submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. 02/05/09 Follow-up received 31-Mar-2009: added product complaint investigation results.									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug(s) Not Reported				MEDI0007879	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0342988	03/18/2009	TX	3.0			F	02/05/2009	A non-serious spontaneous report of 29 patients received expired FLUMIST was received from a physician concerning a 36-month-old female.  The patient's medical history included no history of asthma.  Concomitant medications were not available.  On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008).  The reporting physician was concerned regarding efficacy and loss of potency due to the expired product.  Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications).  There were no adverse events associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  This case is being submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. Based on th results of the investigation, the root cause for the medication errors were caused by 1) customers nto discarding product from the previous season 2) product expiring diuring the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 05-Feb-2009 and incorporated into the narrative, physician confirmed that there were no adverse events associated with the medication error. Additional information was received on 31-Mar-2009 and incorporated into the narrative product complaint investigation results.									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug(s) Not Reported				MEDI0007874	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0342989	03/18/2009	TX	3.0			M	02/05/2009	A non-serious spontaneous report of 29 patients received expired FLUMIST was received from a physician concerning a three-year-old male.  The patient's medical history included no history of asthma.  Concomitant medications were not available.  On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008).  The reporting physician was concerned regarding efficacy and loss of potency due to the expired product.  Since the facility only administered the immunization and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications).  There were no adverse events associated with theses medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  This case is being submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error.  Additional information was received on 05-Feb-2009 and incorporated into the narrative: gender and age; confirmation that there were no adverse events. Additional information was received on 31-Mar-2009 and incorporated into the narrative product complaint investigation results.									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug(s) Not Reported				MEDI0007872	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0342990	03/18/2009	GA				F	02/17/2009	A non-serious, spontaneous report of administration of full dose in one nostril was received from a nurse concerning a female child of unknown age subsequent to FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information was received on 17-Feb-2009 and incorporated into the narrative: No adverse event reported.									Y	10/10/2008	10/10/2008	0		OTH	OTH	Not Reported				MEDI0007857	1						1	Drug administration error	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0342991	03/18/2009	NJ	4.0	4		M	02/03/2009	A non-serious spontaneous report of administration of expired product was received from a nurse practitioner concerning a four year-old male, which occurred after receiving expired FLUMIST.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the Flu season resulting in some medication errors that occurred shortly after the product expired. Follow up information was received on 06-Mar-2009 and incorporated into the narrative: confirmed that there were no adverse events associated with the medication error. Additional information was received on 09-Apr-2009: product complaint investigation results.									Y	01/22/2009	01/22/2009	0		OTH	PVT	Concomitant Drug(s) Not Reported				MEDI0007856	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500563P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0342992	03/18/2009	NJ	3.0	3		F	02/03/2009	A non-serious spontaneous report of administration of expired product was received from a nurse practitioner concerning a 41-month-old female, who received FLUMIST.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with agency's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Follow up information was received on 06-Mar-2009 and incorporated into the narrative, confirmed thate there were no adverse events associated with the medication error.									Y	01/29/2009	01/29/2009	0		OTH	PVT	Concomitant Drug(s) Not Reported				MEDI0007855	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~IN500563P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0343101	03/18/2009		50.0	50		F	03/06/2009	Information has been received from a pharmacist concerning a 50 year old female with hypertension and no history of drug reactions/allergies, who on 1-OCT-2008, was vaccinated with HEPTAVAX. Concomitant therapy included influenza virus vaccine (unspecified), BENICAR, furosemide and ATIVAN. On 2-OCT-2008 the patient developed an itchy rash from her neck to her knees. The patient had been treated with unspecified steroids and antihistamines but the rash persisted. A skin biopsy, performed by an unspecified dermatologist, revealed possible drug reaction. The patient also developed numbness of the fingers of her left hand. At the time of reporting, the patient has not yet recovered. The patient sought medical attention with an office visit. No product quality complaint involved. Additional information has been requested.				Y					N	10/01/2008	10/02/2008	1	Skin biopsy, possible drug reaction	OTH	UNK	Furosemide; ATIVAN; BENICAR	Hypertension			WAES0812USA00053	1						1	Biopsy skin; Hypoaesthesia; Rash pruritic	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~MERCK & CO. INC.~~UNK~UN~UN~HEP B (FOREIGN)~1	USA	Emergency room visit	Influenza
0343449	03/18/2009	SD	6.0	6		F	03/04/2009	This case was reported by a healthcare professional and described the occurrence of vaccination complication in a 6-year-old female subject who was vaccinated with HAVRIX for prophylaxis. Previous and/or concurrent vaccination included FLUMIST; manufacturer unspecified given on 21 November 2008. On 21 November 2008 at 15:45, the subject received 2nd dose of HAVRIX (.5 ml, unknown, left arm). On 21 November 2008, at the time of vaccination with HAVRIX, the subject experienced vaccination complication and accidental blood exposure. The reported noticed when the administering nurse drew back the syringe prior to injecting HAVRIX there was blood in the vaccine (vaccine complication). The vaccine was given in this manner and no adverse events have been experienced. At the time of reporting the outcome of the events were unspecified.									U	11/21/2008	11/21/2008	0	UNK	PVT	OTH		Unknown	No concomitant mediations or relevant medical history. No adverse events were reported with previous vaccinations.		A0758584A	1						1	Vaccination complication; Wrong technique in drug usage process	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~~2~UN~LA~HEP A (HAVRIX)~1	USA		Influenza
0343450	03/18/2009	PA	0.8	0	.8	F	03/04/2009	This case was reported by a consumer and described the occurrence of fever in a 10-month-old female subject who was vaccinated with HAVRIX, GlaxoSmithKline. A physician or other health care professional has not verified report. Previous and/or concurrent vaccination included FLUZONE, non-GSK; SANOFI; unknown given on 16 October 2008. On 16 October 2008 at 12:00, the subject received 1st dose of HAVRIX vaccine (unknown, left thigh). On 16 October 2008, less than one day after vaccination with HAVRIX, the subject experienced drug use for unapproved indication and wrong vaccine administered. On 31 October 2008, fifteen days after vaccination with HAVRIX, the subject experienced fever. The mother of a 10-month old subject reported that her physician intended to give a Hepatitis B vaccine but gave the subject a dose of HAVRIX instead. The subject was 10-months old at the time of immunization, which is below the recommended 1-year indication. The mother reported that two weeks later, the subject had a fever of 103 degrees which resolved. At the time of reporting the outcome of the events were resolved. Follow-up information was received on 24 November 2008, via physician who reported that HAVRIX 720 was given instead of Hepatitis B vaccine to a 10-month-old baby on16 October 2008. The physician advised the parent and the parent mentioned that the subject had a fever for 2 days about a week after the HAVRIX dose. The subject has not been seen in the office.				Y					Y	10/16/2008	10/16/2008	0	Unknown	PVT	PVT		Unknown	No concomitant medications or relevant medical history. No adverse events were reported with previous vaccinations. Subject is reported to be a healthy child.		A0758810A	1						1	Inappropriate schedule of drug administration; Pyrexia; Wrong drug administered	FLU3~SANOFI PASTEUR~U2848AA~UNK~~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB234BA~1~UN~LL~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0343451	03/18/2009	MA	22.0	22		F	03/04/2009	This case was reported by a physician via a sales representative and described the occurrence of hives in a 22-year-old female subject who was vaccinated with HAVRIX and influenza virus vaccine for prophylaxis. On 24 October 2008 the subject received 2nd dose of HAVRIX in the left arm and a dose of Flu vaccine (unknown manufacturer). Either that same day or the next day (25 October 2008) the subject developed hives. She presented to the office. The treating physician implied that the hives resolved, but the reporting sales representative was not certain, thus the resolution was reported as unknown. The physician was not certain whether the hives were caused by the HAVRIX or the concomitant flu vaccine given on the same date. The physician considered the event was possibly related to vaccination with HAVRIX and FLU vaccine. Follow-up information received on 19 December 2008 indicated that hives began on 24 October 2008. They resolved on an unknown date and were considered to be possibly related to treatment with HAVRIX.				Y					Y	10/24/2008	10/24/2008	0	UNK	PVT	PVT		Unknown	It was reported that the subject is prone to allergies, but specific allergies were not provided. The subject has no reactions with the first HAVRIX dose.		A0758842A	1						1	Urticaria	FLU3~SANOFI PASTEUR~U2769AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB251BA~2~UN~LA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0342106	03/19/2009	MD	2.0	2	.9	M	03/11/2009	Pt received flu vaccine & got INFLUENZA B anyway.				Y					Y	12/23/2008	03/10/2009	77	INFLUENZA B Positive	MIL	MIL						1						1	Influenza; Influenza serology positive	FLU3~SANOFI PASTEUR~UT2794DA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0342167	03/19/2009	WA	34.0	34		F	03/19/2009	Flu vaccine administered at 10 a.m. when I was 34 weeks and 5 days pregnant. This was a twin pregnancy with lots of monitoring (ultrasounds, etc.) At approximately 3 p.m., my OB observed normal fetal heart activity in both babies. At 5:30 p.m. during a nonstress test, it was discovered that baby A had developed atrial flutter, with a heart rate of 422. Babies were surgically delivered the next morning due to this condition. Baby A was successfully cardioverted into a normal rhythm. Baby A was kept in NICU for three days to monitor cardiac status. 4/17/09-records received for DOS 10/13-10/17/08-admitted with 35 week twin pregnancy with fetal arrhythmia. Scheduled repeat cesarean delivery.					Y	4			Y	10/13/2008	10/13/2008	0	No cause for development of atrial flutter was found. Normal echocardiograms, normal blood cultures, normal EKG, normal chest xray.	UNK	UNK	prenatal vitamins, vitamin D, zantac, colace	none	twin pregnancy	none~ ()~~0.00~Patient|none~ ()~~0.00~Sibling|none~ ()~~0.00~Sibling		1						1	Blood culture negative; Chest X-ray normal; Drug exposure during pregnancy; Echocardiogram normal; Electrocardiogram normal; Foetal disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0342175	03/19/2009	CA	5.0	5		F	03/19/2009	Noticed black dot on patient's right arm immediately after administration of MMR. 04/16/2009 Office protocol requires MMR to be administered via Safety Glide needle.									U	12/19/2008	12/19/2008	0	None.	UNK	UNK		None noted.	Unknown.			1						1	Injection site haematoma	FLU3~SANOFI PASTEUR~U2808AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1507X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0342176	03/19/2009	WA	22.0	22		M	03/19/2009	Patient complained of tightness and pain in his chest, went to the clinic at the Hospital on 15 Mar 09.  The clinic then transferred him to another hospital in where he was kept under observation for two days.  We have not yet received the paperwork from hospital as they have not processed the release of information request yet so we do not know the diagnosis from there. 3/24/09 Received hospital medical records of 3/16-3/17//2009. FINAL DX: myopericarditis Records reveal patient experienced intermittent chest pain x approx 2 days & 1 day which increased, tenderness at injection sites, left axillary pain.  Seen in outlying ER where EKG & cardiac enzymes were abnormal & transferred to higher level of care. Cardio consult done.  Tx w/ASA.  Remained stable, pain decreased & d/c to home w/Cardio f/u.				Y	Y	2			Y	03/04/2009	03/15/2009	11	ASAP TROPONIN I, 6.14 H; CK, 450 H; MMB, 14.9 H*; GLUCOSE,  96;   UREA NITROGEN, 10; CREAT, 1.3; BUN/CREATININE, 7.7; SODIUM, 140; POTASSIUM, 3.4 L; CHLORIDE, 99; CARBON DIOXIDE, 29; AANION GAP 4, 15; OSMOLALITY,CALC, 269; CALCIUM, 9.6; T PROTEIN, 7.9; ALBUMIN, 4.0; ALANINE AMINOTR, 9; ASPARTATE AMINO, 41 H; ALK PHOS, 121; TOTAL BILI, 0.51; ASAP WBC, 10.6 H; RBC, 5.36; HGB, 16.1; HCT, 46.4; MCV, 86.6; MCH, 30.0; MCHC, 34.6; RDW, 12.5; PLT, 251; MPV, 8.9; LYMPH %, 29.1; MONO %, 10.2; NEUT %, 58.4; EOS %, 2.0; BASO %, 0.3; LYMPH #, 3.1 H; MONO #, 1.1 H; NEUT #, 6.2; EOS #, 0.2; BASO #, 0.0 LABS: ESR 12, CPK 651, CK MB 40.6, Troponin 10.62.  Tox screen, CXR & UA neg.  EKG w/ST segment elevation w/PR depression.  Echocardiogram WNL.	MIL	MIL	None	None	None  PMH: Allergy: PCN, anaphylactic reaction.			1						1	Alanine aminotransferase increased; Anion gap; Aspartate aminotransferase increased; Basophil count decreased; Blood albumin normal; Blood alkaline phosphatase increased; Blood calcium normal; Blood chloride normal; Blood creatine phosphokinase increased; Blood creatinine increased; Blood glucose normal; Blood osmolarity decreased; Blood potassium decreased; Blood sodium normal; Blood urea normal; Carbon dioxide increased; Chest discomfort; Chest pain; Eosinophil count increased; Haematocrit normal; Haemoglobin normal; Lymphocyte count normal; Mean cell haemoglobin concentration; Mean cell haemoglobin normal; Mean cell volume; Mean platelet volume normal; Monocyte count increased; Neutrophil count normal; Platelet count normal; Protein total normal; Red blood cell abnormality; Red cell distribution width; Troponin increased; White blood cell count increased; Anion gap normal; Axillary pain; Blood calcium normal; Blood chloride normal; Blood creatine phosphokinase MB increased; Blood creatine phosphokinase increased; Blood creatinine increased; Blood glucose normal; Blood osmolarity decreased; Blood potassium normal; Blood sodium normal; Blood urea normal; Carbon dioxide normal; Chest discomfort; Chest pain; Electrocardiogram abnormal; Injection site pain; Myopericarditis; Troponin I increased; Anion gap increased; Axillary pain; Blood calcium normal; Blood chloride normal; Blood creatine phosphokinase MB increased; Blood creatine phosphokinase increased; Blood creatinine increased; Blood glucose normal; Blood osmolarity decreased; Blood potassium decreased; Blood sodium normal; Blood urea nitrogen/creatinine ratio; Blood urea normal; Carbon dioxide normal; Chest discomfort; Chest pain; Electrocardiogram abnormal; Injection site pain; Myopericarditis; Troponin I increased	FLU3~SANOFI PASTEUR~U2941AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~EMERGENT BIOSOLUTIONS~VV04003A~1~ID~LA~SMALLPOX (ACAM2000)~1|TYP~SANOFI PASTEUR~B04242~UNK~UN~LL~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|FLU3~SANOFI PASTEUR~U2941A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|SMALL~EMERGENT BIOSOLUTIONS~W04003A~UNK~ID~UN~SMALLPOX (ACAM2000)~2|TYP~SANOFI PASTEUR~B04242~UNK~UN~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~2|FLU3~SANOFI PASTEUR~U2141AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~3|SMALL~EMERGENT BIOSOLUTIONS~W04003A~UNK~~UN~SMALLPOX (ACAM2000)~3|TYP~SANOFI PASTEUR~B04242~UNK~UN~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~3	USA	Hospitalisation	Influenza
0342197	03/19/2009	VA	4.0	4		F	03/18/2009	Chicken pox 3/18/09 after 2 vaccinations for VARIVAX 9/26/05 12/9/08.									Y	12/09/2008	03/18/2009	99		PVT	PVT		OME; URI	Hx takes x 2; speech delays; OME			1						1	Varicella	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC143085AA~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2828AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A0492~4~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0266X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1155X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0342275	03/20/2009	ID	1.3	1	.3	M	03/20/2009	Fever up to 105				Y					U	03/17/2009	03/18/2009	1	CBC. Blood and urine cultures	PVT	PUB	None	Few red papular scattered on chest	None			1						1	Blood culture; Culture urine; Full blood count; Pyrexia	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B085BA~4~UN~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT2794EA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB320BA~1~UN~LL~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0342280	03/20/2009	TX	20.0	20		F	03/15/2009	Non stated.										03/16/2009				PUB	UNK	TOPOMAX;  SEASONALE		Allergy to ASPIRIN;  Chiari malformation			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2749AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB252AA~1~UN~RA~HEP A (HAVRIX)~1	USA		Influenza
0342289	03/20/2009	LA	0.5	0	.5	F	03/13/2009	Vomiting, fever to 103 degrees. Fever was noted (rectal) 102.7 on admit to ER, uncontrollable vomiting. Dehydration. Neuro signs intact. Received IV fluids, ZOFRAN 1 mg IVP and TYLENOL 110mg.				Y					Y	12/15/2008	12/15/2008	0	CBC; CMP	PVT	PUB	None	stuffy nose	GE Reflux			1						1	Dehydration; Full blood count; Metabolic function test; Pyrexia; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B173AA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT2792EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF513AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~C99098~3~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0342305	03/20/2009	ME	21.0			M	03/20/2009	Patient developed pain and redness at the injection site of Flu vaccine.  His entire right shoulder turned purple.									Y	01/17/2009	01/19/2009	2		PUB	PVT		Ear surgery				1						1	Injection site erythema; Injection site pain; Skin discolouration	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0342333	03/20/2009	CT	60.0	60		F	03/10/2009	Had cold symptoms in Nov - Dec. Flu symptoms 1st Jan. Saw P.C. 1/5/09, showed signs of choking often, called paramedics 1/18/09 - could not stand after a fall. Hospitalized that night 21 or 22nd Spinal tap done, treatment started.   4/3/09 MR received for DOS 1/27-2/23/2009 with D/C DX:  Dysphagia. Guillain-Barre Syndrome.  Hx of alcoholism and dementia.  Respiratory insufficiency.  Pt initially presented to local hospital 1/19/09 with profound progressive weakness and dx with GBS.  Intubated following a choking episode which resulted in acute respiratory distress. Developed LLL pneumonia and a small PE. TX with IVIG.  Transferred to current facility for vent mgmt 2' to increasing hypoxia and O2 requirements. Trach, IVC filter and PEG placed. Transferred to long term rehab 2/23/09			Y	Y	Y	60	Y		U	10/22/2008	01/18/2009	88	Spinal tap, 21 or 22; No reflexes in feet and legs 20th. Labs and Diagnostics:  LP with normal cell count, glucose and protein. Barium swallow (+) for dysphagia.  CXR (+) for pneumonia vs CHF.  Echo suggests pulmonary HTN.  CT Brain (+) for small vessel ischemic changes, sinusitis and mastoiditis, no acute pathology. CT chest/abd  (+) for pericardial effusion and atherosclerotic aorta, no acute disease. BS consistantly in 110-120's. Chem (+) for some electrolyte abnormalities. Hct, Hgb, RBCs low.  Platelets high. ABGs abnormal. EKG abnormal. Sputum cx (+) for MRSA and Klebsiella	OTH	OTH		None	Low back surgery 10/2006; High blood pressure; Gout. PMH:  ETOH abuse. Dementia.  COPD.  HTN.  Gout. OA. lumbar laminectomy. L PTX with thoracotomy and partial pneumonectomy. R renal insufficiency			1						1	Areflexia; Choking; Dysstasia; Fall; Influenza; Lumbar puncture; Nasopharyngitis	FLU3~CSL LIMITED~01049211A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Life Threatening,Hospitalisation	Influenza
0342328	03/21/2009	CT	58.0	58		F	03/21/2009	Patient received both a pneumovax and influenza injection on 10/21/08, The influenza vaccination was given in patient's right arm, and the pneumovax in the left. Patient is now reporting that since the pneumovax injection in her left arm, some 5 months ago,she has been experiencing persistant neural pain.									U	10/21/2008	10/21/2008	0	none, as patient only recently reported this.	PUB	UNK	unknown was not assessed at the time.	none noted	unknown	left arm pain~Pneumo (Pneumovax)~1~58.00~In Patient		1						1	Neuralgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA175AA~2~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0224X~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0342373	03/23/2009	TN				U	03/19/2009	Initial report received 09 March 2009 from a health care professional which involved a cluster of two patients. Two patients, also reported as employees (ages and dates of birth not reported), had received FLUZONE during early September 2008 (one patient received FLUZONE lot number U2761AA, second patient lot number not reported), and on an unspecified date during March 2009, both patients were diagnosed with the flu, strain B. One patient was confirmed as type B by the Tenzyme test. At the time of the report, it was unclear which patient received FLUZONE lot number U2761AA, and which patient tested positive for Influenza Type B. The patient's recovery status was not reported. No additional information was provided at the time of the report. The reporter for this case is the same as for case numbers 2008-02996, 2008-03923, 2008-03924, 2008-03925, 2008-03926 and 2008-03927. Documents held by sender: None.				Y					U	09/01/2008	03/01/2009	181	Tenzyme Test: one patient confirmed as Type B.	UNK	UNK			Not reported		200900920	1						1	Influenza; Influenza serology positive	FLU3~SANOFI PASTEUR~U2761A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0342393	03/23/2009	NY	10.0	10		F	03/23/2009	Possible vaccine failure. Child expired with Flu A cultured. 5/20/09-autopsy report received-COD-cardiopulmonary arrest. Due to: systemic infection with influenza type A/H1. Sudden onset of muscle and leg cramps on 2/14/09, URI symptoms last day or so including sore throat. Suddenly developed tachypnea fever and diaphoresis within 20n minutes of onset of leg cramps. In ED fever of 107, tachycardia and dyspnea, developed flutter then bradycardia. Intubated, v-tach, coded and expired.	Y	02/15/2009							N	10/10/2008	02/13/2009	126	Flu A cultured; IVP, brain, heart  5/20/09-records received-CXR negative.	PVT	UNK		None	Ventral Septal Defect 5/20/09-records received-Clinical history of patent ductus arteriosus and ventricular septal defect. Slit-like communication between atria. One of twins.			1						1	Death; Influenza; Influenza serology positive	FLU3~SANOFI PASTEUR~27A3EA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Results in Death	Influenza
0342396	03/23/2009	ME	63.0	63		M	02/26/2009	Vaccines given 2/23/09.  Patient monitored 30 minutes post vaccines.  No problems or complaints reported.  Patient returned for visit 2/26/09 & reported rash onset est. 20 hours post vaccinations.  No respiratory complaints.  Rash is resolving.  Pt has not yet contacted PCP.  He agrees to do so today 2/26/09.									Y	02/23/2009	02/24/2009	1		OTH	UNK	None reported	None	None known			1						1	Rash	FLU3~SANOFI PASTEUR~UF2839AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1648~1~IM~RA~HEP B (FOREIGN)~1	USA		Influenza
0342460	03/23/2009	NY	30.0	30		F	03/23/2009	supraventricular tachycardia, dizziness, chest pain. Brought to emergency room by ambulance and admitted to a cardiac telemetry unit for 7 days. Numerous tests and procedures performed, ie, echo, EPS, tilt table...  4/28/09 Received hospital medical records of 1/28-2/4/2009. FINAL DX: supraventricular tachycardia; vasovagal syncope Records reveal patient experienced palpitations upon awakening similar to prior episodes but she was unable to break out of it with vagal maneuvers.  Also had chest pain, SOB, diaphoresis, dizziness & nausea.  Admitted to CCU for monitoring.  Had couple of pre-syncope episodes while hospitalized.  No episodes of SVT on monitor.				Y	Y	7			N	01/21/2009	01/28/2009	7	Diagnosed with Postural Tachycardia Syndrome  LABS: electro physiology study abnormal w/atrial tachycardia & atrial flutter.  Tilt table test (+) w/bradycardia & hypotension.  echocardiogram.	UNK	UNK	none	none	PMH: MVP, SVT, herniated disc.  Allergy: latex.			1						1	Chest pain; Dizziness; Echocardiogram; Postural orthostatic tachycardia syndrome; Supraventricular tachycardia; Tilt table test	FLU3~SANOFI PASTEUR~U2742AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0342483	03/23/2009	MT	23.0	23		F	03/19/2009	Soreness in arm for over a month - Stinging pain, unable to lift arm.									N	02/06/2009	02/06/2009	0	MRI - Pending.	MIL	MIL		None	None			1						1	Injected limb mobility decreased; Nuclear magnetic resonance imaging; Pain in extremity; Injected limb mobility decreased; Nuclear magnetic resonance imaging normal; Pain; Paraesthesia; X-ray normal	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPVX~UNKNOWN MANUFACTURER~~UNK~UN~UN~HPV (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~013349111A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~UNKNOWN MANUFACTURER~~UNK~IM~UN~HEP A (NO BRAND NAME)~2|HPV4~MERCK & CO. INC.~0188U~2~UN~UN~HPV (GARDASIL)~2	USA		Influenza
0342523	03/24/2009	CA	1.0	1	.0	M	03/17/2009	4 days after vaccine got vesicular rash on face.				Y					U	03/09/2009	03/13/2009	4	none	PVT	UNK		Candidal diaper rash; contact dermatitis				1						1	Rash vesicular	FLU3~SANOFI PASTEUR~UT27946A~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1040X~UNK~UN~LL~HEP B (RECOMBIVAX HB)~1|MMR~MERCK & CO. INC.~1210X~UNK~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~D16182~UNK~UN~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1763X~UNK~UN~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0342527	03/24/2009	WA	4.0	4		F	03/19/2009	Erythema multiforme- Itchy red rash all over body. Tx BENADRYL and cortisone ointment.				Y					U	03/10/2009	03/18/2009	8		PVT	PUB						1						1	Erythema multiforme; Rash erythematous; Rash generalised; Rash pruritic	DTAP~SANOFI PASTEUR~C3000AA~5~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2908AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB274BA~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1507X~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1392X~2~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0342544	03/24/2009	NY	4.0	4		M	03/24/2009	Right upper arm completely swollen, warm but not tender, swelling was beyond elbow on 2/19/09. Recheck if redness starts to extend rather than recede or if fever or tenderness continue warm compresses.									U	02/18/2009	02/18/2009	0		PVT	PVT						1						1	Injection site swelling; Injection site warmth	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B103AC~1~IM~RA~DTAP + IPV (KINRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500T89P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB259AA~UNK~IM~RA~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1571X~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1754X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0342548	03/24/2009	CA	53.0	53		F	03/24/2009	I developed a 103 degrees fever for 2 days and cellulitis at the injection site.  I also still have a lump in my arm.				Y					Y	03/05/2009	03/06/2009	1		PUB	OTH	Vesicare; need to check w/hospital	Food poisoning	Drug Allergies- Penicillin & Sulfa			1						1	Injection site cellulitis; Mass; Pyrexia	FLU3~CSL LIMITED~0264911A~UNK~IJ~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~9722106~UNK~IJ~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0342568	03/24/2009	NY	30.0	30		M	03/18/2009	None stated.										03/18/2009				UNK	UNK						1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88907~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~SANOFI PASTEUR~U2078BA~UNK~UN~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0342591	03/25/2009	FL	67.0	67		F	03/23/2009	Initial information was received on 26 November 2008 from a health care professional. A female patient received an injection of FLUZONE SV 2008-2009 (lot number not reported) on 18 September 2008. On the day of vaccination the patient developed redness and swelling at the injection site and had swelling of the eyelid. The patient had a doctor's visit and was prescribed an antibiotic for the localized reaction. The recovery status was not reported. Follow-up information was received from a health care professional on 12 March 2009 which indicated that the patient had been hospitalized for five days. Based on this new information, the case has been upgraded to serious. The patient, a 67-year-old female, received FLUZONE SV 2008-2009 and PNEUMOVAX (Merck, lot not reported) on 18 September 2008. Approximately 48 hours post-vaccination, she developed swelling of the eyelid and injection site inflammation, and was subsequently hospitalized for five days. The event recovered. List of Documents held by sender: None.					Y	5			Y	09/18/2008	09/20/2008	2	None reported.	PVT	OTH			Not reported.		200803767	1						1	Eyelid oedema; Injection site erythema; Injection site inflammation; Injection site swelling	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0342600	03/25/2009	AR	59.0	59		F		4-20-07 - onset bruising dx: ITP. 4-25-08 - GUILLAIN-BARRE Syndrome - hosp 32 days.  4/1/09  MR received for 4 DOS- 11/27-29/07 with DX:  Thrombocytopenia, 12/3-9/07 with DX: ITP, 12/14-19/07 with dx ITP and 4/25-5/27/2008 with D/C DX:  Guillain-Barre Syndrome which is slightly improved. Pt initially presented  to PCP's office for c/o bruising on hands and buttocks and blood blisters in the mouth.  Platelet count found to be 7K and pt referred for admission. Reports recent dizziness and near syncope. Tx with platelet transfusions and steroids with platelet count 47K by d/c. Readmitted 12/3/07 for dropping platelet count (5K) with bruising and bleeding. Started on IVIG with count up to 128K by 12/8/07. D/C to f/u as outpt.  Pt returned 4/25/08 with c/o diffuse weakness, decreased grip strength. Reflexes were initially intact but lost in several days with progressive weakness. Tx with IVIG and steroids with little improvement, then plasmapheresis. Recovery was very slow and pt d/c to rehab 5/27/08.			Y		Y	32	Y		Y	11/08/2007	11/20/2007	12	Labs and Diagnostics:  US spleen WNL.  Bone marrow bx c/w platelet destruction.  Flow cytometry with non-specific findings.  Chromosome analysis-normal XX. Platelets 7K on admission up to 47K by d/c.  CT brain & cervical spine WNL. MRI brain WNL except sinusitis. EMG c/w acute motor axonal neuropathy EMG/NCS c/w GBS. RBC, Hgb & Hct remained low from 5/12/08-d/c. BS consistantly high.  BUN up to 30.  Creatine low 0.3-0.4. CSF cx (-).  Campylobacter jejuni Ab (+). Lyme (-). CXR (+) for atelectasis, cardiomegaly.	PUB	PUB		None	None PMH:  migraine, hysterectomy with bladder suspension. Allergy to sulfa and antihistamines.		AR0909	1						1	Contusion; Guillain-Barre syndrome; Idiopathic thrombocytopenic purpura	FLU3~SANOFI PASTEUR~U2514AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0342604	03/25/2009	AR	3.0	3		F	11/18/2008	Rec'd flu vacc 110708; presented to ER 110808 with itchy red rash over entire body face, extrem. Started with neck, broke out with all over rash next morning.				Y					Y	11/07/2008	11/07/2008	0		OTH	OTH	None	None	None			1						1	Rash generalised; Rash pruritic	FLU3~SANOFI PASTEUR~U2840AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0342605	03/25/2009	NC	38.0	38		F	03/17/2009	None Stated										03/17/2009				UNK	UNK						1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88907~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0342606	03/25/2009	AL	54.0	54		F	03/10/2009	pain in (R) arm at inj site. redness, warmth, temp 100 deg. SEPTRA given for possible cellulitis. TYLENOL/MOTRIN for discomfort, apply cool compresses to site. Refer to V.I.S given at time of admin. of vaccine									Y	02/16/2009	02/18/2009	2	None	PVT	PUB		None	Hypertension; Hypercholesterolemia; Allergic; Amitriptyline			1						1	Body temperature increased; Injection site erythema; Injection site pain; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~09883~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0867X~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0342654	03/25/2009	MO	5.0	5		M	03/25/2009	Mother states client woke up from a nap around 4pm the same day of vaccination and his legs were stiff and he was screaming in pain.  Mom states she took him to the ER and the dr stated it was related to the pain of the injection.  His pain was more in his right leg than his left.  The ER dr told mom to continue motrin or tylenol for pain as needed.				Y					Y	03/20/2009	03/20/2009	0		PUB	PUB		history of flu type A 2-3 weeks prior to vaccination	Autism			1						1	Injection site pain; Musculoskeletal stiffness; Screaming	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B116AB~5~IM~RL~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~U2800EA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB608AA~3~IM~RL~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0342655	03/25/2009	OH	13.0	13		F	03/25/2009	Approximately 4:00PM 12/7/08 Symptom: Headache This came on suddenly.  Pain level was a 5.  Described as aching pain on back (upper) head.  Was seen in ER on 12/9/08 after pain had continued for 48+ hours with no abatement (increased to level 7 pain) and getting < 4hrs of sleep per night. ER treated with Toradol, Midrin and Phenegrin. Pain level reduced to 4 and discharged from ER.  Pain continued and increased to Level 7.  Again treated at ER with no long term benefits.  This has continued since 12/7.  Pain is continual 24 x7. 3 ER visits and 4 day hospital admittance on 2/23/09 for high dose steroids IV.  This did not aleviate pain. Insomnia that has occurred since 12/7 has been treated with Ambien since 2/26/09 3/26/09-records received for ED visit 12/9/08-C/O gradual onset of headache began 3 days ago. Bilateral sharp pain 7 out of 10. Nausea.  Assessment:Headache.  4/20/09-records received-for DOS 2/23-2/26/09-Presented with headaches since 12/7/08 constant and localized to occipital region throbbing in character. HA is made worse by activity and unable to attend school for past 2 months. As HA worsens C/O feeling nauseous and has had decreased PO intake with 15 pound weight loss. Insomnia. Malaise, weakness, fatigue. Abdominal pain.				Y	Y	4				12/04/2008	12/07/2008	3	MRI (1/20/09)- pineal cyst - neurosurgeon validated this was not impacting any vessels which would cause headache.  CATSCAN: normal / Sleep study: no sleep apnea.  46 awakenings.  Blood tests: normal / Allergy tests (2/2/09) : no allergies / Cardiology: PVC's on average 22% of time.  Cardiologist validated this was not cause of headaches / Lumbar Puncture (2/23/09): normal 3/26/09-records received-CT brain negative.  4/20/09-records received-Pineal cyst noted on MRI. PVCs seen on EKG during sleep study. CSF opening pressure normal. CSF counts normal. MRIs negative. Negative sleep study.	UNK	UNK	N/A	None	No pre-existing diagnosed issues 3/26/09-records received-PMH: sprained thumb and mononucleosis 4/20/09-records received-PMH:Depression PVCs.			1						1	Allergy test negative; Blood test normal; Computerised tomogram normal; Headache; Insomnia; Lumbar puncture normal; Nuclear magnetic resonance imaging abnormal; Sleep disorder; Sleep study abnormal; Ventricular extrasystoles	FLU3~SANOFI PASTEUR~U2795AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0342656	03/25/2009	NC	59.0	59		F	03/25/2009	59 yo BF presented to clinic 3/24/09 with c/o pins and needles and tingling in right arm x ~ 3.5 weeks. Onset was weeks following 02/09/2009 vaccination with Hepatitis B vaccine and influenza IM injections in the right arm. MD will continue to monitor. Unclear association at this time. Pt will return to clinic for f/u in ~1 month.				Y					U	02/09/2009	03/01/2009	20		UNK	UNK	Current meds: 1. Toprol XL 200 mg po daily 2. Aspirin 81 mg po daily 3. Plavix 75 mg po daily 4. Quinapril 80 mg po daily 5. Hydrochlorothiazide 25 mg po daily 6. Levemir insulin 32 units SubQ bid 7. Novolog insulin 16 units tid ac 8. Amlod	none	PMH: DMII, HL, HTN, CAD, Gout, Status post multiple lacunar CVA with residual left side coordination deficit			1						1	Paraesthesia	FLUX~SANOFI PASTEUR~U2849AC~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~MERCK & CO. INC.~0398x~UNK~IM~RA~HEP B (RECOMBIVAX HB)~1	USA	Emergency room visit	Influenza
0342660	03/25/2009	IN	5.0	5		M	03/25/2009	Mother noted a red, hot raised area on the child's left upper arm 2 days after receiving the vaccines. It was 3 in in diameter and had a white area in the center. The mother gave the child one dose of Benadryl and the area went away.									Y	03/17/2009	03/19/2009	2		UNK	UNK	NONE	NONE	NONE			1						1	Erythema; Skin warm; Swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B061AA~5~IM~LA~DTAP (INFANRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500589P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~MERCK & CO. INC.~1580X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0123Y~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0342664	03/25/2009	SD	8.0	8		F	12/30/2008	Left hand red, swelling and itching, mom administered childrens benadryl										12/29/2008	12/30/2008	1		PVT	PUB						1						1	Erythema; Oedema peripheral; Pruritus	FLU3~SANOFI PASTEUR~U2829AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0342671	03/25/2009	VA	52.0	52		F	03/25/2009	Itchy, hot rash broke out the night of the vaccination on elbows, moving the buttocks and then ankles.  Feet sweating profusely.  Lasted about 3 weeks.  After another week, jaw, shoulders and back starting aching.  Then right toes started tingling.  Muscle twitches and spasms occurred primarily in back at first, now all over.  The tingling progressed to both feet and some in the hands.  MRI of brain and spinal cord showed nothing but age related degeneration.  Blood tests all negative except ANA slightly elevated (133).  Neurologist put me on prednisone and Gabapentin.  Seemed to have little effect on pain and tingling.  Tingling has progressed to groin, back and stomach at times.  Pain persists in back, upper shoulders and neck.  Tingling especially in toes and exacerbated upon exercise and hot bath.  Neurologist just upped the dose of Gabapentin to see if it would alleviate the symptoms.  Another blood test for ANA will be done.									U	12/16/2008	12/16/2008	0	MRI of thoracic, cervical and lumbar spine.  MRI of brain.  Blood tests for Lyme, thyroid, Vit D deficiency, and complete blood panel.	UNK	UNK	Lisinopril 5 mg  Completed Bactrim for sinus infection two weeks prior	No, but getting over sinus infection	High blood pressure			1						1	Back pain; Blood test; Borrelia burgdorferi serology; Full blood count; Hyperhidrosis; Muscle spasms; Muscle twitching; Musculoskeletal pain; Nuclear magnetic resonance imaging; Nuclear magnetic resonance imaging brain; Pain in jaw; Paraesthesia; Pruritus; Rash; Thyroid function test; Vitamin D deficiency	FLU3~SANOFI PASTEUR~UT804AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0331132	03/26/2009	VA	2.0	2	.2	F	03/18/2009	(R) thigh cellulitis (with question of osteomyelitis/deep abscess on x ray => referred to Pediatric Ortho at hospital to R/O above); fever.				Y					Y	10/30/2008	10/30/2008	0	11/4 (after worsening on Po Abx) x ray (as above); Bld cx-NG; 339>11.4 <6.9  34.0 (35P 4B 51L 4AL 4M 2E); ESR=35	PVT	PVT	SINGULAIR, CLARITIN SYRUP	None	Amox Allergy			1						2	Blood culture negative; Differential white blood cell count abnormal; Haematocrit normal; Haemoglobin normal; Injection site cellulitis; Pyrexia; Red blood cell sedimentation rate increased; White blood cell count increased; X-ray limb abnormal; Cellulitis; Dysstasia; Erythema; Full blood count normal; Injection site nodule; Injection site swelling; Pain in extremity; Pyrexia; Red blood cell abnormality; Skin warm; Ultrasound scan abnormal; X-ray abnormal	FLU3~SANOFI PASTEUR~13844~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~UT2794DA~1~IM~RL~PNEUMO (PNEUMOVAX)~2|PPV~MERCK & CO. INC.~1384U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~3	USA	Emergency room visit	Influenza
0342736	03/26/2009	VA	6.0	6		F	03/24/2009	rash - scattered papules -> Probable chickenpox *Child rec'd 2 doses of VARIVAX dose #1 age 12 mos. dose #2 age 6 yr.				Y					Y	09/26/2007	03/24/2009	545		PVT	PVT	None	None	None			1						1	Rash papular; Varicella	FLU3~SANOFI PASTEUR~U2457FA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0342741	03/26/2009	TX	40.0	40		M	03/20/2009	None stated.										03/20/2009				UNK	UNK						1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2749AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0342748	03/26/2009	TX	9.0	9		F	03/20/2009	Chicken pox #2 given on 3/17/09 and came back on 3/19/09 with (R) arm posterior redness and swelling. Tx: Ice daily to affected area for 20 mins and apply triple abx ointment bid x 7 days.									Y	03/17/2009	03/19/2009	2		PUB	OTH	AMOXIL; ZYRTEC; PREVACID; Vitamins; Albuterol	(R) earache	NKDA			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U2829AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1780X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0342795	03/26/2009	MA	66.0	66		M	03/16/2009	12/2/08 S&S inc. numbness/tingling in hands/feet. 12/3/08 ER for intense pain in joints = Dilaudid. 12/5/08 medical center = constipation/MAALOX. 12/7/08 numbness/tingling hands/feet & muscle control problems & pt fell x2 & went to clinic & transferred to hospital & currently still in rehab since 12/12/08.  5/22/09 Hospital records received DOS 12/7/08 - 12/12/08. FINAL DIAGNOSIS: Guillain-Barre syndrome, urinary retention, Paroxysmal atrial fibrillation, autonomic instability, partial CN IV palsy. Post Vaccination: abdominal pain, multiple joint pain, progressive extremity weakness resulting in multiple falls. Tingling sensation palms. Hands became weak, cold intolerance, constipation, bloody diarrhea. Course lung sounds, diminished lung sounds. Diminished sensation extremities. Loss of reflexes lower extremities. Withdrew foot on right with upgoing toes. Poor hand finger coordination. Diplopia IVIG administered. Episodes of hypertension and hypotension.				Y	Y	5	Y		U	11/05/2008	12/02/2008	27	MRI and Lumbar puncture on 12/7/08 at hospital. Medical center-Lyme titre, Influenza testing  5/22/09 Hospital records received DOS 12/7/08 - 12/12/08. LABS and DIAGNOSTICS: CHEM - Sodium 134 (L) Potassium 3.2 (L) Chloride 97 (L) Glucose 112 (H) Phosphorus 1.8 (L) AST(SGOT) 46 (H) LDH 227 (H) CK 750 (H). CBC - HCT 39.2 (L) WBC 13.6 (H) MCHC 37.9 (H). LP - protein 151 (H) WBC low. Urine - blood 3+ protein 1+ ketones trace CaOx crystals present. Transthoracic echocardiogram - atrial dilitation and LVH. ECG - Sinus Bradycardia. MRI Lumbar / Thoracic / Cervical reveals demyelinating polyneuropathy.	PUB	PUB	Aspirin 81mg's daily 5/22/09 Hospital records received DOS 12/7/08 - 12/12/08.  ibuprofen, omeprazole, Dilaudid, milk of magnesia, Colace, aspirin, vitamins, fish oil, hydralazine, Flomax, acetominophen, Bisacodyl Rectal, Enoxaparin, Gabap	No	Flat Feet 5/22/09 Hospital records received DOS 12/7/08 - 12/12/08. melanoma, seborrheic dermatitis, pneumonia, infected wrist, arthroscopic knee surgeries, umbilical hernia repair, fusion of left hallux.		MA0903	1						1	Arthralgia; Borrelia burgdorferi serology; Constipation; Fall; Hypoaesthesia; Influenza serology; Lumbar puncture; Muscle disorder; Nuclear magnetic resonance imaging; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0342800	03/26/2009	WA	1.9	1	.9	M	03/26/2009	Fever ; Febrile Seizure				Y					Y	03/25/2009	03/26/2009	1	CBC + CXR	PVT	PUB		Cough	None			1						1	Chest X-ray; Febrile convulsion; Full blood count; Pyrexia; Chest X-ray; Febrile convulsion; Full blood count; Pyrexia	DTAP~SANOFI PASTEUR~C3081AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2794~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB274BA~1~IM~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1120X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~D05879~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1401X~1~SC~LL~VARICELLA (VARIVAX)~1|DTAP~SANOFI PASTEUR~C3081AA~4~IM~LL~DTAP (DAPTACEL)~2|FLU3~SANOFI PASTEUR~UT2794~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB274BA~1~IM~RL~HEP A (HAVRIX)~2|MMR~MERCK & CO. INC.~1120X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~2|PNC~PFIZER\WYETH~D05879~4~IM~RL~PNEUMO (PREVNAR)~2|VARCEL~MERCK & CO. INC.~1401X~1~SC~LL~VARICELLA (VARIVAX)~2	USA	Emergency room visit	Influenza
0342805	03/26/2009	CA	60.0	60		F	03/26/2009	Rash on chest 3 days after administration. Rash was clustered only in this area.									Y	02/05/2009	02/08/2009	3	none-all per pt	PVT	PVT	CLARITIN; PANTOPRAZOLE; ESTRIVG; Vitamin D + calcium	none	Osteopenia; hx ovarian neoplasm			1						1	Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~90000~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARZOS~MERCK & CO. INC.~1556X~UNK~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0342812	03/26/2009	FL	4.0	4		F	01/09/2009	Large, red inflammatory reaction, right thigh from upper thigh almost to knee with warmth and tenderness.				Y					Y	10/06/2008	10/06/2008	0	none	PVT	PVT		none	none			1						1	Injection site erythema; Injection site inflammation; Injection site pain; Injection site warmth	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B103AC~1~IM~UN~DTAP + IPV (KINRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500545P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0342815	03/26/2009	MA	45.0	45		M	03/25/2009	Pain in upper right arm and neck and swelling upper right chest since flu injection 2/25/09. Notices pain in upper right arm when he lifts things.									U	02/25/2009	02/25/2009	0		PVT	OTH			HTN; Triglycerides; reflux; myopathy; pelvic pain			1						1	Injected limb mobility decreased; Injection site pain; Neck pain; Swelling	FLU3~SANOFI PASTEUR~U2898FA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2996AA~UNK~UN~LA~TDAP (ADACEL)~1	USA		Influenza
0342846	03/27/2009	MN	58.0	58		M	03/27/2009	DURING LATTER PART OF FEBRUARY PATIENT REPORTED TO LOCAL EMERGENCY ROOM WITH COMPLAINT OF WEAKNESS AND LEG PAIN.  WAS TOLD HE HAD A MUSCLE STRAIN GIVEN ANTI-INFLAMMATORY (IBUPROFEN) AND SENT HOME.  RETURNED A SECOND TIME SOME DAYS LATER UNABLE TO WALK AND IN EXTREME PAIN.  THE EMERGENCY ROOM PHYSICIAN AT THAT TIME WITH THE HELP OF NEUROLOGY SPECIALIST AT CLINIC GAVE THE DIAGNOSIS OF GUILLAIN BARRE SYNDROME.  PATIENT WAS SUBSEQUENTLY TRANSPORTED TO THE HOSPITAL WHERE HE WAS STABILIZED AND THEN SENT TO THE REHABILITATION SECTION OF THIS HOSPITAL.  THE PATIENT IS CURRENTLY (03/27/2009) IN THIS FACILITY.  4/15/09 received hospital medical records of 3/8-3/24/2009. FINAL DX: acute Guillain-Barre syndrome; UTI; stage 2 coccyx decubitus ulcer; hyponatremia, resolved; neuropathic bladder; deconditioning. Records reveal patient experienced progressive LE weakness, left facial droop; UE weakness; urinary retention.  Had been out of country 1/09 & had cold, fever, cough, nasal congestion.  Approx 2/28/09 began to feel unwell, developed pain in legs & back.  Seen in ER & dx w/muscle sprain.  No improvement w/meds & in fact developed weakness of LEs requiring walker use.  Saw PCP & noted to have UTI & tx w/antibiotics.  Progressive weakness continued until pt unable to get OOB & developed left facial droop.  Seen again in ER & transferred to higher level of care.  Neuro & Uro consults done.  LP done.  Tx w/IVIG x 5 days.  Feeding tube placed.  Gradually improved & transferred to inpatient rehab.			Y	Y	Y	60			U	12/03/2008	03/01/2009	88	Guillain Barre  LABS: ESR 13, CRP 0.76.  Sodium 129, chloride 96(L), creatinine 0.5(L).  Liver enzymes WNL.  CSF: glucose 65(N), protein 380(H), segs 16(H), c/s neg.  CBC: hematocrit 37.4(L), lymphs 10%(L), monos 13%(H), segs 74%(H), eos 0%(L).  Blood c/s neg.  CT head WNL.  MRI spine WNL except for bulging discs.  Renal US WNL.   Swallow study abnormal w/dysphagia.  US of BLEs WNL.	UNK	UNK	03/05/2009 lEVAQUIN 750, IBUPROFEN 800 02/27/2009 MIRAPEX, FLUTICASONE 2/27/09 DIAZEPAM 02/10/2009 DIAZEPAM	NONE	NONE TO MY KNOWLEDGE  PMH: back pain, depression, s/p vasectomy, diverticulosis, proctitis, cataracts, dysuria.  Allergy: codeine, HA & flushing.  Family hx: CVA, DM, cancer.	NONE~ ()~~0.00~Patient|UNKNOWN TO ME~ ()~~0.00~Sibling|UNKNOWN TO ME~ ()~~0.00~Sibling		1						1	Abasia; Guillain-Barre syndrome; Muscle strain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89982~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0342851	03/27/2009	TX	64.0	64		M	03/27/2009	64M h/o DM, HTN, HLD, BPH p/w weakness that started yesterday midmorning.  He first felt weak during work, when he noticed that he could not keep a good grip on his handtools; he had trouble squeezing the trigger on the nailgun and using his screwdriver. The weakness was equal on both sides.   Morning of admission, the patient was feeling even more weak, and he fell once in his house because of weakness in his legs, R>L.  He has had a lot of problems walking and keeping his balance.  There have been no changes to his medication regimen.  He has not had any previous episodes of this type of weakness.  He says the weakness is equal on both sides.  He has not had any blurry vision or double vision.  Denies slurred speech, drooping or drooling out of one side of his face, problems swallowing/choking, or confusion/disorientation.  He recently got his flu shot 10/16 (about one month prior to  presentation).  He also had a stomach infection last weekend (seven  days prior to presentation) where he had a lot of liquid diarrhea,  especially on the day of onset of that illness.  He also had nausea and  vomiting that weekend, and was unable to keep any food down until  Monday.  Since Monday, there was complete resolution of his symptoms.   He did not try any new foods; he did not eat any old/expired canned foods; no one around him is sick.  No recent travels.   Patient was felt to have an acute inflammatory  demyelinating polyneuropathy (Guillain Barre Syndrome) and was treated with IVIG. Patient is currently in a skilled nursing unit, has a motorized wheelchair.  4/8/09 Received hospital medical records of 11/13-12/1/2008. FINAL DX: Guillain Barre syndrome; SIADH resolved; hypotension resolved. Records reveal patient experienced nausea/vomiting/diarrhea following flu shot & developed progressive distal to proximal weakness.  LP done & found to have high protein.  Admitted to ICU.  Tx w/IVIG x 5 days. Improved slowly & transferred to SNF for inpatient rehab.     4/21/09 Received additional hospital medical records including: EMG/NCS report; Neuro & Neurosurg consults; Derm, Dental Uro consults; d/c summary of 1/28-2/2/09 rehospitalization for UTI while in rehab; additional labs.					Y	18		Y	N	10/16/2008	11/13/2008	28	LABS: CBC WNL.  Sodium 127(L).  CSF: protein 130 (H), glucose 78(H), WBC 33(H), lymphs 26%, neutros 73%, RBC 2380(H).  EMG/NCS abnormal.  Blood, CSF, urine c/s neg, although tx for presumed UTI.	MIL	PUB	rosuvastatin, cyclobenzaprine, naproxen, doxazosin, finasteride	none	diabetes, hypertension, hyperlipidemia, degenerative joint disease  PMH: BPH.			1						1	Asthenia; Balance disorder; Blood product transfusion; Diarrhoea; Fall; Gait disturbance; Gastrointestinal infection; Grip strength decreased; Guillain-Barre syndrome; Muscular weakness; Nausea; Vomiting; Wheelchair user	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89297~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0342890	03/27/2009		58.0	58		F	03/27/2009	We received the following information from a consumer via the agency on 12 MAR 2009: A 58-year-old female patient, was vaccinated with FLUVIRIN i.m. in October 2008. Immediately after vaccination she felt dizzy. 48 hours after vaccination she lost consciousness for 1 hour. Further, she complained about exacerbation of chronic health problems since vaccination i.e. weight loss, pain and concentration problems. The patient has a history of toxicity problems, weight loss, reaction to mercury poisoning, high arsenic level, pain and concentration problems. At time of report, the patient had not recovered. She refused information on treating MD and did not want her MD contacted. Concomitant medication: Phenobarbital, TENORMIN , Lisinopril, AVINZA, Simvastatin. Company assessment : Seriousousness criterion: medically significant. Causality: insufficient data. No medical information/confirmation provided. Expectedness assessment according to label: The reported symptoms are not expected after vaccination with FLUVIRIN. No change in benefit-risk ratio. No measures necessary. Med Com no. NA09-000772									N	10/01/2008	10/03/2008	2		OTH	OTH	Phenobarbital; TENORMIN; Lisinopril,; AVINZA; Simvastatin.	Allergy to chemicals; weight decreased; metal poisoning; pain; disturbance in attention	Blood arsenic increased		MA20090648	1						1	Condition aggravated; Disturbance in attention; Dizziness; Immediate post-injection reaction; Loss of consciousness; Pain; Weight decreased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0342917	03/27/2009	VA	47.0	47		F	03/25/2009	Reported receipt of FLUSHIELD Lot #4998274 in 1999 to her left deltoid. The next day she noted fine pruritic red spots to bilateral cheeks progressing into and about her ears with a sense of throat itching and tightness. She denied shortness of breath, chest pain, difficulty swallowing, facial/oral swelling or rash elsewhere else. She went to the ER at work where she reports being given IV medication and released on a 7 day taper prednisone and BENADRYL. Her throat tightness resolved but the rash persisted another 2 days before resolving w/o reoccurrence. She has not received any vaccinations since. She reported the above reaction was similar to past/current food reactions which she describes as nasal/oral and skin itching, tight throat w/ sensation of closing off, runny nose, congestion, and redness to face with eating fresh apples, cherries, Jack fruit, and pomegranates. She has no problems eating eggs or cooked apples (apple sauce). She develops palmar dermatitis with carrots. She has had a similar fine red pruritic face/neck/ears rash December 2008 after using new make-up (where make-up was applied). She self-treated with CLARINEX/BENADRYL and removed/stop use of make-up with resolution w/in 3 days. She also reported total body pruritic hive-like rash within 24 hours after first dose of Hep B vaccine in summer 1989. She did not receive 2nd or 3rd vaccinations. Memory of events was unclear. She did not remember what vaccinations she received from birth to age 25. She denied any other vaccine adverse events. She has seasonal pollen allergies spring and fall (worse in spring) with watery eyes. Powdered gloved cause itchy hands/rash and sneezing. She is tolerant of Nitrile gloves. She has not had an Allergy evaluation. The pt has not received a flu or any other vaccination since 1999.				Y					Y	10/08/1999	10/09/1999	1	Labs; 05FEB2009; Egg, white 703 0/I; Egg, yolk 451 neg; Egg, whole 604 0/I; Gelatin (Bovine) 237, neg; Latex 487, neg; Testing Time Reaction/comments; PST (controls + // -) 0920 5x5/40x35 mm // 0x0 mm; Apple (commercial extract) 0920 0x0 mm; Apple (fresh) 0920 6x6/45x45 mm [mild erythema in proximal AC fossa about 30 min after test, cleared spontaneously after about 10 mins]; Gelatin 0920 0x0 mm; Egg (white) 0920 0x0 mm; Egg (whole) 0920 0x0 mm; Flu vaccine 1:10 0920 0x0 mm; Flu vaccine 1:1 (FS) 0940 2x2/0x0 mm; ID (control -) 1000 0x0 mm; Flu vaccine 1:1, 000 1000 4x4 / 5x5 mm; Flu vaccine 1:100 1030 5x5 / 30x30 mm [positive]; 25 Mar 2009 0952 EDT	PVT	PVT	Unknown	denied	seasonal and food allergies	Hives/rash~Hep B (no brand name)~1~0.00~Patient		1						1	Allergy test; Pruritus; Rash pruritic; Reaction to previous exposure to any vaccine; Throat irritation; Throat tightness	FLU3~PFIZER\WYETH~4998274~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0342918	03/27/2009	VA	56.0	56		M	03/26/2009	The patient reported receipt of IM influenza vaccination at NMCP while working the ER in 2002 or 2003.  He denied any illness (URI) prior to this vaccination (date unknown).  Approximately 12-24 hours post vaccination, he complained of feeling tired, had a stuffy nose, sinus and chest congestion.  These symptoms worsened over the next few days to include shortness of breath and a cough which disrupted his ability to sleep.  He was evaluated by his PCP and placed on an antibiotic and TUSSINEX.  The cough medicine made him sleepy and he was unable to work for approximately one week before symptoms resolved.  He did not receive any further influenza vaccination until 12/7/2007 (AFLU #A312BA).  He again reported experiencing similar nasal, sinus and chest congestion, cough, and difficulty sleeping at night due to coughing and shortness of breath as in 2002/2003.  Early winter is a time period he experiences sinus infections.  He reported being out of work 2 weeks before symptoms eased.  However symptoms persisted for the next several months.  He was treated by his PCP with two antibiotics, FLONASE, PROVENTIL, ADVAIR, etc.  (There are no available records of evaluation by his Allergist).  In January 2009 he was referred to pulmonology where he was diagnosed with asthma and placed on SIMACORT.  One month later all asthma medications were stopped due to worsening breathing difficulty.				Y					Y	12/07/2007	12/08/2007	1	Unknown	MIL	MIL	denied	denied				1						1	Activities of daily living impaired; Asthma; Cough; Dyspnoea; Fatigue; Nasal congestion; Respiratory tract congestion; Similar reaction on previous exposure to drug; Sinus congestion; Sinusitis; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0342868	03/28/2009	NY	4.0	4		M	03/28/2009	Received Flu vaccine on 3/12/09.  Had R leg pain starting on 3/18 and fever on 3/17.  Seen in the office on 3/19 and noted to be walking slowly on toes, mainly wanting to be carried every where. On exam he had pain in hip with internal and external rotation, but no tenderness.  CBC and ESR normal.  I suspect he has transient synovitis.  I called home today - a couple days after I saw him he was fine to 2 days.  since that time he has intermittently c/o hip pain.  Never as severe as on 3/19.									U	03/12/2009	03/18/2009	6	see above - ESR 7, WBC 7.0 with 2 Bands, 36 SEGS and 43 lymph and 14 MONO.  Hgb 12.9	PVT	PUB	pulmicort and or albuterol	none	Asthma	none~ ()~NULL~~In Patient		1						1	Arthralgia; Full blood count normal; Gait disturbance; Haemoglobin normal; Injection site pain; Lymphocyte percentage increased; Monocyte count increased; Neutrophil percentage decreased; Pyrexia; Red blood cell sedimentation rate normal; Synovitis; White blood cell count normal	FLU3~SANOFI PASTEUR~v2799AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0341516	03/30/2009		53.0	53		F	02/28/2009	I went with my physician husband to receive routine immunizations.  A tech administered the injections not writing down which was given, where, a total of 4:  HEP B, TD, Pneumovax & Typhoid.  I am a registered nurse and questioned non documentation of which injection was given where, or if they could be given together.  I was assured by him that he was properly trained.  He was not a medical person, only trained on the job!  I left to go home with my husband.  When I returned home, I felt warm + sluggish + could not do any normal business- No hunger, just panic within 2 1/2 my temp went form 99.6 to over 106.5 My husband took me later to hospital, very seriously ill I today have problems with walking any lengths & fevers, & memory problems.  I now live alone & cannot afford Rx's, doctors visits, or hospital visits, as my insurance stopped.  I need HELP!  I also have severe problems in my right knee & can not push body pressure on it without help.  Because of unsteadiness from this I fell in my bathroom + had to have brain surgery.  Also, exacerbate congenital spinal stenosis- Not able to work at all.  I used to go to Dr for increase BP & fevers & aches, but no longer can afford this I have very little money.  I do feel that I have been tossed aside I have written about this once before, to no reply.  Please help me.  My right knee was the worst & still is.  I have no health insurance + must suffer.  This is not your fault.  I am a victim of the times + sad.  Have to use cane.  Need help to buy groceries/sister.  Must be in bed with illness and fevers up to 102.5 at any given time.  I am 60 years old + since this happened I am going steadily down hill.			Y					Y	N	10/28/1998	10/28/1998	0		UNK	UNK			None			1						2	Nuclear magnetic resonance imaging; Unevaluable event; Activities of daily living impaired; Arthropathy; Balance disorder; Body temperature increased; Decreased appetite; Fall; Feeling hot; Gait disturbance; Memory impairment; Panic reaction; Pyrexia; Sluggishness; Spinal column stenosis; Surgery	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1|HEP~UNKNOWN MANUFACTURER~04374~UNK~UN~UN~HEP B (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0871~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1|TD~UNKNOWN MANUFACTURER~453118~UNK~UN~UN~TETANUS DIPHTHERIA (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEP~UNKNOWN MANUFACTURER~04334~UNK~UN~UN~HEP B (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0871~UNK~UN~UN~PNEUMO (PNEUMOVAX)~2|TD~UNKNOWN MANUFACTURER~453118~UNK~UN~UN~TD ADSORBED (NO BRAND NAME)~2|TYP~SANOFI PASTEUR~~UNK~UN~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~2	USA	Life Threatening,Disabling	Influenza
0342921	03/30/2009	TN	73.0	73		F	03/26/2009	Initial report received from a health care professional on 13 March 2009. The reporter stated that two of his patients got the Flu after receiving FLUZONE; however information was received for only one patient. An elderly female patient had received FLUZONE SV 2008-2009 (lot number, route/site of administration not reported) on 16 October 2008 and an unspecified amount time later she developed the flu. On 09 March 2009, the patient had laboratory testing performed for Influenza virus A & B IGG, IGM, and IGA ABS with the following results: Influenza A: IgG (4.94), IgM (1.09), IgA (1.4) and Influenza B: IgG (3.38), IgM (<0.80), IgA (<0.80). Reference ranges - (<0.80 = negative); (0.80 - 1.20 = Equivocal); (>1.20 - positive). According to the laboratory report received, This test(s) was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by (the laboratory). This test should not be used for diagnosis without confirmation by other medically established means. The patient's recovery status was not reported. No additional information was provided at the time of the report. Follow-up information received 17 March 2009 from a health care professional. The reporter confirmed that patient had been 74-years-old at the time of the event. The patient had received an intramuscular right deltoid injection of FLUZONE on 16 October 2008 and 140 days later, she developed sinus congestion; aching behind eyes, red pharynx and her face was flushed. She had no adenopathy and her lungs were clear. Laboratory test results had been positive for influenza A and B and additional labs revealed Hgb (14.1), Hct (42), WBC (3,300) and platelets (151,000); Diff: PMN (70.3), Lymph (23), Prolymphs (6.3). A throat culture grew normal flora. The patient had no pre-existing illnesses or medical conditions and no illness at the time of vaccination. She had not received any other vaccines within four weeks of receiving FLUZONE. The patient was recovering as of 17 March 2009. It had been previously reported that a second patient had developed the Flu after receiving FLUZONE; however new information received noted that the second patient had not received an influenza vaccination prior to contracting the flu. No additional information was provided at the time of the report. Documents held by sender: Lab titers.				Y					N	10/16/2008	03/05/2009	140	09/Mar/2009: Influenza virus A&B IgG, IgM and IgA ABS, Influenza A: IgG, (4.94), IgM (1.09), IgA (1.4); Influenza B: IgG (3.38), IgM (<8.80), IgA (<0.80), Reference ranges - (<0.80 - negative); (0.80 - 1.20 = Equivocal); (>1.20 = positive). Hgb (14.1), Hct (42), WBC (3,300) and platelets (151,000); Diff:PMN (70.3), Lymph (23), Prolymphs (6.3). Throat culture: normal flora.	PVT	PVT			Not reported. From information received 17 March 2009, the patient had no past medical history and she had not  been ill at the time of vaccination. She had not received any other vaccines within four weeks of FLUZONE.		200901066	1						1	Culture throat negative; Eye pain; Flushing; Haematocrit normal; Haemoglobin normal; Influenza; Influenza serology positive; Pharyngeal erythema; Platelet count normal; Sinus congestion; White blood cell count decreased	FLU3~SANOFI PASTEUR~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0342012	03/31/2009		7.0			M	03/27/2009	This case was retrieved via a search of the scientific literature 17 March 2009. A seven-year-old male patient received Influenza virus vaccine, Hepatitis A vaccine, and Varicella vaccine (manufacturers, lot numbers, date, site, and routes of administration not reported). Seven to nine days post-vaccination, he began experiencing a rash which initially presented as a single raised, pruritic lesion on the sole of the left foot. It subsequently got larger and began to resemble cellulitis. He was treated with oral antibiotics with no effect, and the rash progressed to his face and extremities. It was described as painful and pruritic, with lesions ranging from flat and target-lesion-like to bright, red, raised, and urticarial. He developed an intermittent low grade fever, and laboratory testing revealed a WBC of 23.7 x 10 (9) L with 59% eosinophils. A lesion biopsy revealed eosinophilic cellulitis/WELL's syndrome. All symptoms resolved without treatment within eight weeks of diagnosis, and was asymptomatic at his last follow-up visit. Documents held by sender: None.				Y					Y				WBC of 23.7 x 10 (9) L with 59% eosinophils. Lesion biopsy revealed eosinophilic cellulitis/WELL's syndrome.	UNK	UNK			None reported.		200901118	1						2	Body temperature decreased; Eosinophil percentage increased; Eosinophilic cellulitis; Erythema; Pain; Pyrexia; Rash; Rash pruritic; Urticaria; White blood cell count increased; Biopsy skin; Eosinophil count increased; Eosinophilic cellulitis; Erythema; Pain; Pyrexia; Rash; Rash pruritic; Urticaria; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~UNK~UN~UN~VARICELLA (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~2|VARCEL~UNKNOWN MANUFACTURER~~UNK~UN~UN~VARICELLA (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0343043	03/31/2009		1.4			M	03/27/2009	Initial report received on 17 March 2009 from a literature collection.  A previously healthy 17 month old boy was inoculated with FLUZONE SV '2005-'2006 USP (lot number U1804AA) by intramuscular injection. Three weeks later, when he was otherwise well and did not appear to be in pain, his mother noted that he was esotropic. There was no history of antecedent febrile illness, trauma, or family history of strabismus. Ophthalmic examination, revealed a 45 degree esotropia in primary gaze increasing to a 65 degree esotropia in right gaze and orthotropia in left gaze. Examination of ductions revealed marked limitation of abduction of the right eye and full ductions of the left eye, consistent with right lateral rectus paralysis. Cycloplegenic refraction revealed +1.5 D spherical error for each eye. The remainder of the ophthalmic examination, including dilated fundus examination, was normal. A complete neurological examination was unremarkable. Magnetic resonance imaging (MRI) was performed, including T1, T2 fluid attenuation inversion recovery (FLAIR), and fat saturation views of the brain and orbits. Gadolinium-enhanced imaging used 3 mm slices without interslice gap and non enhanced imaging used 1 mm slice resolution of the brain and orbits. Fast imaging used 1 mm slice resolution of the brain and orbits. Fast imaging using steady state acquisition sequencing was used to achieve submillimter resolution in assessing the course of the sixth nerve from the ventral medulla into the cavernous sinus and orbit. Neuroimaging did not reveal any abnormality. Part-time occlusion therapy of his left eye was instituted, and repeat examination at 4 months revealed a 15 degree esotropia in primary gaze with improved abduction of the right eye. Subsequent examinations revealed orthotropia in primary gaze and a 10 degree esotropia in right gaze with minimal limitation of abduction of the right eye at 6 months and orthotropia in all diagnostics positions of gaze at 9 months at which time occlusion therapy was discontinued. The child was then well until 1 year after the onset of symptoms when 3 weeks after receiving FLUZONE (lot number U2174GA), his esotropia recurred. He otherwise appeared well and did not appear to be in pain. He exhibited a 10 to 20 degree incomitant esotropia with limitation of abduction of the right eye. The patient was orthotropic in levoversion. The remainder of the ophthalmic examination was unremarkable. A neurological examination and MRI of the brain and orbits without gadolinium failed to reveal any abnormalities. Repeat examination at 6 weeks demonstrated orthotropia in primary and left gaze, and a 10 degree esotropia in right gaze. The residual motility deficit failed to resolve over the subsequent 7 months. 27 March 2009: A corrective version with the latest received date of the previous version, 17 March 2009, was created in order to add the second dose of FLUZONE to the case. The reporter of this case is the same as case number 2009-01134. List of Documents held by Sender: none.				Y					N				Magnetic resonance imaging (MRI) was performed, including T1, T2 fluid attenuation inversion recovery (FLAIR), and fat saturation views of the brain and orbits. Gadolinium-enhanced imaging used 3 mm slices without interslice gap and non enhanced imaging used 1 mm slice resolution of the brain and orbits. Fast imaging using steady state acquisition sequencing was used to achieve submillimeter resolution in assessing the course of the sixth nerve from the ventral medulla into the cavernous sinus and orbit. Neuroimaging did not reveal any abnormality.	OTH	OTH			The patient had no history of antecedent febrile illness, trauma, or family history of strabismus.		200901116	1						1	Neurological examination normal; Nuclear magnetic resonance imaging normal; Ophthalmological examination abnormal; Ophthalmoplegia; Strabismus	FLU3~SANOFI PASTEUR~U1804AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0343054	03/31/2009	AZ	4.0	4		F	03/30/2009	L arm Swelling With mild erythema.				Y					Y	03/26/2009	03/27/2009	1	None	PVT	PUB	OMNICEF	ABD. Pain	None			1						1	Injection site erythema; Injection site swelling	DTAP~SANOFI PASTEUR~C3083BA~5~UN~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2799AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A04490~4~SC~UN~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0907X~2~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1535X~2~SC~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0343057	03/31/2009	KS	48.0	48		F	01/23/2009	Right after injection I got very hot and dizzy. I could not stand up. Health Dept had to lay me down. My blood pressure was very low, I was pale in color. After about 30 to 45 minutes I got in car and went home. Where another 2 hours before I was able to get out of bed.									Y	01/16/2009	01/16/2009	0		PUB	PVT	None	none	none			1						1	Dizziness; Dysstasia; Feeling hot; Hypotension; Pallor	FLU3~SANOFI PASTEUR~U2770AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0343072	03/31/2009	CO	5.0	5		F	03/27/2009	Redness, swelling of left arm. 48 hrs. after receiving Imm's. 0 temp.									Y	03/25/2009	03/27/2009	2		PVT	PUB						1						1	Injection site erythema; Injection site swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B088BA~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2828AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A1229~5~IM~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1580X~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1548X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0343112	03/31/2009	AZ	18.0	18		F	03/31/2009	After administration of GPV, patiient expressed feeling weak and nausea. Provider was notified and patient was taken to tx room. Initial BP was 104/69; dropped  94/52; NS 500ml was ordered + bolus: between 11:30-11:40; patient improved, was alert.									Y	03/03/2009	03/03/2009	0	none	PUB	PUB	N/A	None	None	N/A~ ()~NULL~~In Patient	AZ0903	1						1	Asthenia; Blood pressure decreased; Nausea	FLU3~SANOFI PASTEUR~U2829AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB239AA~1~IM~LA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~0843X~1~IM~RA~HPV (GARDASIL)~1	USA		Influenza
0343113	03/31/2009	CA	0.75	0	.8	F	03/31/2009	Pt was noted to have a thigh mass one month after administration of hib3 and flu vaccines.  The mass continued to grow and was removed on 12/23/08.  It was determined to be a subcutaneous granuloma annulare.				Y					Y	10/15/2008	11/18/2008	34	an ultrasound and MRI were obtained prior to surgery	UNK	UNK	none	no	eczema, perinatal HIV exposure			1						1	Granuloma annulare; Injection site mass; Nuclear magnetic resonance imaging; Surgery; Ultrasound scan	FLU3~SANOFI PASTEUR~U2787EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF505AA~3~IM~LL~HIB (ACTHIB)~1	USA	Emergency room visit	Influenza
0343125	03/31/2009	AZ	46.0	46		M	04/02/2009	Symptoms began the same evening I received the influenza vaccination given at work site. Fever, body aches, sore throat, weak, lightheaded, dizziness.Stayed in bed for about six days.By third day had pain, burning while urinating and blood in urine, along with extreme lower back pain, and bloated stomache.Fever and chills continued. No energy. Fourth day, visited DR., was given antibiotics for U.T.I. and was told E. Coli was found in urine along with blood again. Went through two rounds of antibiotics through December. Dizziness, shortness of breathe, pain and pressure in abdominal, lower back, lower chest, and neck(swollen),armpit areas continue up to now --APril. Numbness from upper left shoulder down to hand. Chills, hot spells, and lightheadedness at nighttime.Often times will lose balance while walking, and sitting to standing position. Symptoms continue--more weakness and loss of balance, shortness of breathe, as of March 31st.				Y					N	11/19/2008	11/20/2008	1	abdominal scan reveals several enlarged lymph nodes. second scan taken two months later, reveals lymph nodes are quite enlarged. High triglyceride count (was normal before adverse reaction to flu shot)	UNK	UNK	None	None. Was in very good health	None			1						1	Abdominal distension; Abdominal pain; Asthenia; Back pain; Balance disorder; Blood triglycerides increased; Blood urine present; Chest pain; Chills; Culture urine positive; Dizziness; Dyspnoea; Dysuria; Feeling hot; Hypoaesthesia; Intra-abdominal pressure increased; Lymphadenopathy; Oropharyngeal pain; Pain; Pyrexia; Swelling; Testicular swelling; Ultrasound abdomen abnormal; Urinary tract infection	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0343181	04/01/2009	NJ	39.0	39		F		Started having severe stabbing ache in shoulder & upper arm approximately 2-3 days after vaccine.  Began having, numbness & tingling.  Discoloration of injection site also indentation in deltoid muscle.  Severe weakness in left arm, sometimes trembling in arm.  Surgery scheduled for 4/13/09.  Nerve damage, Brachial neuritis, impingement syn.  Rotator cuff tear.4/13/09-records received-neurology consult notes for 12/31/08 with C/O pain and weakness in left shoulder. Day after receiving flu shot had intense pain and swelling in muscle and is not getting any better. past 2 months developed weakness, pain and paresthesias in shoulder area, some flattening of muscle over shoulder. PE:significant atrophy of left deltoid muscle with decrease of sensation over that particular muscle. Difficulties abducting left shoulder, deltoid muscle weak. Deep tendon reflexes preserved, sensory exam to pain and temperature normal.  Impression: most likely axonal inury to axillary nerve. office visit 2/6/09-DX: mononeuropathy of axillary nerve and continues with weakness and some paresthesias which began on 10/31/08. Now C/O strange sensation in fingers and nail changes in left hand. Recently diagnosed with focal arthritis changes in left shoulder. 6/10/09 records received from orthopedic consultant 12/17/08-5/20/09.C/O pain involving left shoulder girdle since 10/31/08-after vaccine developed acute pain lateral to injection site and atrophy. Weakness of shoulder with abduction. Sustained injury to shoulder while at work. Impression:findings consistent with possible injury to branch of axillary nerve secondary to injection.  Impingement syndrome. Surgery for rotator cuff repair on 4/27/09. Follow-up: EMG in 2/2010 shows no improvement to axillary nerve damage, still suffering from weakness in left arm and shoulder and pain.								Y	N	10/30/2008	10/31/2008	1	4 MRI's & EMG 4/13/09-records received-EMG demonstrated presesence of devervation in deltoid muscle.  MRI of left shoulder and humerus joint effusion, bursitis. EMG and nerve conduction velocity studies impression of left axonal nmononeuropathy and denervation of left deltoid muscle.	OTH	OTH		None	None			1						1	Arthritis; Axillary nerve injury; Hypoaesthesia; Hypokinesia; Injection site atrophy; Injection site discolouration; Mononeuropathy; Muscle atrophy; Muscle swelling; Muscular weakness; Musculoskeletal pain; Myalgia; Nail disorder; Nerve injury; Pain; Pain in extremity; Paraesthesia; Paraesthesia; Radiculitis brachial; Rotator cuff repair; Rotator cuff syndrome; Tremor	FLUX~UNKNOWN MANUFACTURER~AFLUA187AA~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0343237	04/01/2009	NC	14.0	14		F	04/01/2009	Client became dizzy after vaccination									Y	03/30/2009	03/30/2009	0		PUB	PUB		NONE	NONE			1						1	Dizziness	FLU3~SANOFI PASTEUR~U2828AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB330AA~1~IM~RA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~1312X~1~IM~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2688AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B028AA~1~IM~LA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~0125Y~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0343239	04/01/2009	TX	56.0	56		M	04/01/2009	Patient was given flu shot and pneumonia vaccine right before discharge.  Patient reports that when he got home he began experience generalized pain, redness and swelling at the injection site, elevated blood pressure, and fever of 103.				Y					U	03/15/2009	03/15/2009	0		PVT	PVT	Metoprolol XL 50 mg QD, Hyzaar 100 mg QD, Crestor 10 mg QD	Chest pain NOS	Sulfa drugs			1						1	Blood pressure increased; Injection site erythema; Injection site swelling; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~02349111a~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~9722106~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0343250	04/01/2009	GA	59.0	59		F	04/01/2009	Symptoms:Shortness of Breath, Racing Heart, Anxiety, some Dizzyness,  These symptoms got progressively worse over the course of 2 weeks.  The symptoms appear(ed) to get worse when I ate/eat.				Y					N	03/07/2009	03/08/2009	1		PUB	PVT			Hypertension			1						1	Anxiety; Dizziness; Dyspnoea; Palpitations	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0343255	04/01/2009	NE		0	.0	M	04/01/2009	My son received Influenza vaccine (adult dose) instead of Hepatitis B vaccine. He is now 12 weeks of age. To date, we have not experienced an adverse event. We have no way of knowing if there will be any long term effects.									U	12/31/2008	12/31/2008	0		PVT	UNK	Vitamin K Injection, Erythromycin Eye Ointment	None	Unknown			1						1	No adverse event; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA356AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0343264	04/01/2009	AZ	2.0	2	.3	F	03/19/2009	A serious, spontaneous report of seizure, influenza, wheezing and fever was received from a physician concerning a 27-month-old female subsequent to FLUMIST. The CDC isolated a virus from the child that was confirmed as FLUMIST vaccine type B strain. The patient's past medical history includes abnormal development with a developmental level of a six-month-old and seizure disorder with history of febrile seizures. Concomitant medications included ranitidine. The patient received FLUMIST on 30-Oct-2008 for influenza vaccination. Family members received trivalent influenza vaccination. On 2-Nov-2008 the patient experienced fever, wheezing and seizure and was hospitalized. The patient was diagnosed with influenza. A head CT scan was normal and the white blood cell count was 11.2. It is unknown if the seizure event was febrile in nature. On 7-Nov-2008 the patient was discharged and the events were considered resolved. Additional information was received on 19-Mar-2009 and incorporated into the narrative: changed event term from sick to seizure. Added terms of influenza, wheezing and fever. Added medical history and con meds. Required follow-ups have been performed. Physician did not wish to divulge any additional information.					Y				Y	10/30/2008	11/02/2008	3	2-Nov-2008, CT scan head, normal; Platelet count, 11/02/08, 271; WBC, 11/02/08, 11.2	OTH	OTH	Concomitant Drug(s) Not Reported	Seizures; Febrile seizure	Abnormal development: at 2 years had developmental level of 6 months;		MEDI0008057	1						1	Computerised tomogram normal; Condition aggravated; Convulsion; Influenza; Platelet count normal; Pyrexia; Wheezing; White blood cell count increased	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0343265	04/01/2009	AZ	18.0	18		F	03/27/2009	Pt was given GARDASIL vaccine was informed would have to wait 20 minutes to be observed, pt was sitting on exam table after injection passed out -  falling forward hitting cabinet broke tooth & cut to head.  Pt observed stabilized.  8/5/09 Medical records received DOS 3/27/09. Assessment: Syncopal episode with scalp laceration and tooth fracture. Fell forward off of exam table from seated position, lost consciousness 10-15 seconds. R parietal upper scalp laceration. R front tooth chipped. Upper lip contusion.  8/17/09 Hospital records received DOS 6/14/09 to 6/15/09. Assessment: Right facial cellulitis, fever, broken tooth causing abcess, hyperglycemia, hyponatremia. Patient fell forward and damaged right upper teeth. Root canal performed. Developed increased swelling and redness in right upper part of face. Oral surgeon performed I&D. Pain and swelling increased. 2 cm X 1 cm area of swelling redness and fluctuance posterior to right central incisor on the hard palate.  ICD-9 Codes: 682.0 Cellulitis of Face, 276.1 Hyposmolality, 522.4 AC Apical Periodontitis, 790.29 Other Abnormal Glucose, V45.89 Postsurgical States NEC, 521.81 Cracked Tooth.									Y	03/27/2009	03/27/2009	0	8/5/09 Medical records received DOS 3/27/09. LABS and DIAGNOSTICS: CT Brain w/o Contrast - Moderate ethmoid sinusitis. 8/17/09 Hospital records received DOS 6/14/09 to 6/15/09.  LABS and DIAGNOSTICS: CT Scan - periapical abcess right maxillary bone. CHEM - Glucose 174 mg/dL (H) BUN 5 mg/dL (L) NA 130 mmol/L (L) CL 95 mmol/L (L). CBC - Lymph 5.4% (L) Gran 86.6% (H) ABS Gran 9.3 x10^3/ul (H). Blood culture - no growth.	PVT	PVT		None	8/5/09 Medical records received DOS 3/27/09. Asthma, exercise induced.			1						1	Fall; Head injury; Immediate post-injection reaction; Loss of consciousness; Computerised tomogram normal; Fall; Head injury; Laceration; Syncope; Tooth injury; Body temperature increased; Computerised tomogram normal; Fall; Head injury; Immune system disorder; Mouth injury; Swelling face; Syncope; Tooth fracture; Tooth infection	FLU3~SANOFI PASTEUR~U2750AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1312X~3~UN~RA~HPV (GARDASIL)~1|FLUX~UNKNOWN MANUFACTURER~Unknown~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HPV4~MERCK & CO. INC.~1312X~1~UN~UN~HPV (GARDASIL)~2|FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|HPVX~UNKNOWN MANUFACTURER~~3~IM~LA~HPV (NO BRAND NAME)~3	USA		Influenza
0343272	04/01/2009	ID	66.0	66		F	04/01/2009	Severe pain, induration warmth at injection site with redness at site and extending distal to injection site to elbow.									U	03/25/2009	03/25/2009	0	CBC; NL WBC	PVT	UNK	ESTRADERM PATCH; SYNTHON; LYRICA: LEXAPRO: HCTZ; TYL #3; LISINE; Metformin;  Glipizide	Recent pneumonia with relapse.	Hypothyroid; Fibromialgia; HTN; DMII; Sciatica; Neuropathy			1						1	Full blood count; Injection site erythema; Injection site induration; Injection site pain; Injection site warmth; White blood cell count normal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA167AA~UNK~~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0868X~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0343274	04/01/2009	NY	32.0	32		M	03/23/2009	2 hrs after immunization patient shaking, teeth chattering / cold - felt frozen under 3 blankets. Doesn't believe he had a fever. Achy. Fatigued X 12 hours - recovered with rest. No report of redness at site of injections - Reported 2/4/09 at office visit.									Y	11/24/2008	11/24/2008	0	None	PVT	PVT	None	No	None			1						1	Chills; Fatigue; Feeling cold; Pain; Tremor	FLU3~SANOFI PASTEUR~42765AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C3028BA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0342800	04/02/2009	WA	1.83	1	.9	M	03/26/2009	Fever and febrile seizure				Y					Y	03/25/2009	03/26/2009	1	CBC and CXR	PVT	PUB		cough				1						2	Chest X-ray; Febrile convulsion; Full blood count; Pyrexia; Chest X-ray; Febrile convulsion; Full blood count; Pyrexia	DTAP~SANOFI PASTEUR~C3081AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2794~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB274BA~1~IM~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1120X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~D05879~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1401X~1~SC~LL~VARICELLA (VARIVAX)~1|DTAP~SANOFI PASTEUR~C3081AA~4~IM~LL~DTAP (DAPTACEL)~2|FLU3~SANOFI PASTEUR~UT2794~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB274BA~1~IM~RL~HEP A (HAVRIX)~2|MMR~MERCK & CO. INC.~1120X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~2|PNC~PFIZER\WYETH~D05879~4~IM~RL~PNEUMO (PREVNAR)~2|VARCEL~MERCK & CO. INC.~1401X~1~SC~LL~VARICELLA (VARIVAX)~2	USA	Emergency room visit	Influenza
0343307	04/02/2009	WV	74.0	74		M	04/02/2009	This is a 74yo, Male, came to ER with - Had flu shot yesterday, this am developed rash right thigh, now diffusely spread to both legs, chest arm. Eyes feel matty. Chronic unchanged DOE. Physical exam - NAD General-ambulatory, awake, alert, oriented x3 HEENT- Normal, Lungs-clear, Heart- RSR. Extremities-Large, raised erythmous area medial right and left thigh, left axilla, diffuse small areas of same on chest and back. Assessment- Allergic reaction. Plan- Medrol DP and Loratidine.  5/1/09 ER report received for DOS 12/4/08 with DX:  Allergic reaction..  Pt presented with rash, itching and matty eyes one day s/p Flu shot. PE (+) for diffuse erythematous areas on back, thighs, axilla and chest. Tx:  Medrol and antihist.				Y					Y	12/03/2008	12/04/2008	1		UNK	UNK	Methylprednisolone; Loratadine		Allergies-IOVERSOL; IODINATED INTRAVASC CONTRAST. PMH:  UE DJD, Impingement syndrome, shoulder bursitis, abd pain, diverticulosis, osteopenia, polyarthralgia, allergic rhinitis, knee pain, pharyngitis, back pain, JDD, hemorrhoids, rectal bleeding, BPH, TURP, conjunctivitis, glaucoma, CVA, GERD, venous insufficiency, erectile dysfunction, joint effusion, kidney calculus, R inguinal hernia, essential HTN, COPD, cataract, PVD, OA			1						1	Eye discharge; Hypersensitivity; Rash erythematous	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89297~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0343308	04/02/2009	CA	84.0	84		M		Complete loss of control - 9-13-08. Hospitalized five days. Diagnosed virus syndrome. Home doctor said had Guillain Barre syndrome.  4/8/09 Received hospital medical records of 10/5-10/8/2008. FINAL DX: probable viral syndrome; dental abscess. Records reveal patient experienced generalized weakness, muscle pain, chills, productive cough,  fever 101, toothache x 2 days.  Tx w/antibiotics.  ID consult done.  Fever thought to be from dental abscess.  D/C on continued oral antibiotics & referred to dentist & PCP.  4/20/09 Received vaccine & PCP medical records of 10/27-10/30/09. FINAL DX:viral syndrome, improved. Records reveal patient received flu vaccine on 10/2/08.  RTC 10/27 seen s/p hospitalization w/no new c/o.  RTC 10/30 w/persistent fatigue & body aches.  Supportive tx given.  No further med records available.					Y	4			U	10/02/2008	10/03/2008	1	Community Hospital - virus syndrome  LABS: Neutros 83.5%, lymphs 9.1%.  H/H 13.0/28.1(L).  BMP, BNP, troponin, UA, CXR WNL.  Blood & urine c/s neg.  MRI & CT head WNL & c/w old chronic SDH s/p left craniotomy.  Carotid US WNL.	PVT	UNK	None	None	None  PMH: HTN, CKD, pneumonia, chronic SDH s/p head trauma, BPH, cardiac disease.  Ex-smoker.  Allergy: lidocaine.			1						1	Viral infection	FLU3~SANOFI PASTEUR~U2755AA~5~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0343309	04/02/2009	NY	0.9	0	.9	F	04/01/2009	Acute disseminated encephalomyelitis about 1 week after shot. Fever started. Extreme irritability and screaming. Altered state of consciousness 12 days after. ADEM diagnosed 14 days after, shot and high-dose steroids given.  5/11/09 hospital records received for DOS 12/14/08-1/6/09. FINAL DIAGNOSIS: Acute Disseminated Encephalomyelitis Transferred from another hospital. Altered mental status, quiet whine. Fever, downward gaze with vertical nystagmus. Subsequently intubated for respiratory distress and stridor. Impaired movement of extremities. Stiffening right side of body. Seizures.			Y	Y	Y	27			Y	12/02/2008	12/14/2008	12	5/11/09 hospital records received for DOS 12/14/08-1/6/09. LABS and DIAGNOSTICS: On admission: Normal WBC, LP negative for meningitis, CSF viral culture (-), CT scan brain negative for mass, bleed, hydrocephalus. 12/15/08 CT scan head focal hypodensity L frontal lobe, midbrain, pons, R thalamus. 12/16/08 MRI brain w and w/o contrast - multiple extensive regions of FLAIR/T2 prolongation thalami to brainstem with swelling. MR spectroscopy bilateral thalamic foci with slight elevation in choline. 12/17/08 CMV IGG EIA (+) CMV IGM (-) EBV Panel (-) Influenza culture (-) Mycoplasma not detected. 12/19/08 Chest film - Atelectasis right upper lobe. 12/22/08 blood culture - no growth. 12/26/08 tracheal aspirate - many leukocytes, Moderate Gram-positive cocci, Staph aureus. 12/26/08-12/29/08.	MIL	MIL	None	None	None			1						1	Acute disseminated encephalomyelitis; Altered state of consciousness; Irritability; Pyrexia; Screaming	FLU3~SANOFI PASTEUR~UT2792CA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0343313	04/02/2009	CA				U		L Leg 4 cm erythema and induration.									Y					PVT	PUB	None		None			1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~UT2785DA~3~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C83143~4~UN~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0343314	04/02/2009	NY	1.01	1	.0	M	03/30/2009	Patient developed fever up to 103.2 F rectally on 3/26/2009 - and an erythematous papular rash - descendant - started on face on 3/27/09. Fever resolved on 3/28/09. Rash is less prominent but still present today, on trunk/limb. Child also has small retruauricular adenopathies, soft, nontender.										03/17/2009	03/26/2009	9		PVT	PUB	None	None	Allergic Rhinitis/one episode of RAD.			1						1	Lymphadenopathy; Pyrexia; Rash; Rash erythematous; Rash papular	FLU3~SANOFI PASTEUR~U12792CA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0454X~1~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0092X~1~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0343316	04/02/2009	VA	41.0	41		M	02/09/2009	The moment needle was in right deltoid, pt started to waver w/eyes rolling back.  Pt began to wobble to a fro.  I helped him to his seat.  Water was given.  He stayed around for 15-20 minutes and he left stating that he was feeling okay.									N	02/09/2009	02/09/2009	0		PUB	PVT		Pt stated that he was sick after receiving shot.				1						1	Eye rolling; Immediate post-injection reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89996~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0343323	04/02/2009	RI	1.0	1	.0	F	04/01/2009	fever of 101 degrees, rubbing @ head, increased fussiness There is a question of secondary viral illness				Y					Y	03/31/2009	04/01/2009	1		PVT	PUB		none	none			1						1	Irritability; Pyrexia	FLU3~SANOFI PASTEUR~UT2794CA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~B0009~3~IM~LL~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0343330	04/02/2009	TX	12.0	12		M	03/27/2009	Home visit B/P 106/60 Temp 98.4 Pulse 72 Resp. 20 - c/fired, dizzy. c/o feeling hot and sweating on & off. 1245 T malise 1245 T.C. to mother child taken to hospital informed of vaccine given and c/o melaise, feeling hot/sweaty - Imm. info 9:00 to MD and child felt faint ammonia given to inhale. Lasted x 20-25 min.										03/27/2009	03/27/2009	0		PUB	PUB						1						1	Dizziness; Fatigue; Feeling hot; Hyperhidrosis; Malaise; Pyrexia	FLU3~SANOFI PASTEUR~U2740AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2814AA~1~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B030AA~1~UN~RA~TDAP (BOOSTRIX)~1	USA		Influenza
0343343	04/02/2009	MN	31.0	31		F	12/10/2008	Severe total body itching for 1 1/2 months after the injections. Flushing of skin, resolved in ER, MD and allergy visits.				Y					Y	10/12/2007	10/14/2007	2	numerous labs were done.	PVT	UNK			Sulfa; Demerol; no medical conditions			1						1	Flushing; Laboratory test; Pruritus generalised	FLU3~SANOFI PASTEUR~~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0343349	04/02/2009	NC	18.0	18		F	04/02/2009	CLIENT RECEIVED 7 VACCINES ON THE 26 OF MARCH. CLIENT HAD POSITIVE PREGNANCY TEST TODAY IN OUR ADULT HEALTH CLINIC.									U	03/26/2009	04/02/2009	7		PUB	PUB	NONE	NONE				1						1	Drug exposure during pregnancy	FLU3~SANOFI PASTEUR~U2828AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0062X~3~IM~LA~HEP B (RECOMBIVAX HB)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB330AA~1~IM~LA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~A04902~3~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MNQ~SANOFI PASTEUR~U2688AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B028AA~1~IM~RA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~1387X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0343377	04/02/2009	VA	28.0	28		M	04/01/2009	While attending graduate school, this 40 year old member reported receipt of hepatitis A #1, influenza, and typhoid vaccinations on 11/7/1997. Medical records show tetanus-diphtheria given 8/5/1997 not 11/7/1997. He remembers experiencing flu-like symptoms that evening that worsened the next day to resolve within 24 hours. Day 2 post vaccination (11/9/1997) he began to experience a dull ache to neck near base of skull. This discomfort gradually increased over the next 1 1/2 weeks until he was unable to rotate head side-side due to pain but he could shake it yes without pain. He denied any other symptoms (headache, n/v, muscular weakness, speech or visual disturbance). He presented to medical where he was treated for muscle strain and placed on muscle relaxer and MOTRIN. He took one muscle relaxer and developed a severe headache. He didn't take any more and represented to medical where he was advised he was given a vasodilator instead of muscle relaxer. His medications were changed with resolution of all neck pain for 4 days. On Thanksgiving day he rapidly hyperextended his neck to knock back a shot of whiskey with family members at home when he suddenly felt weird. He was reported to go pale, his coordination was off, and he had a headache. He was unable to stand due to muscle weakness and was assisted to the floor. He denied any paralysis, respiratory or visual complaints. He was taken to an emergency room, admitted and diagnosed with dissected cerebral artery. He remained in ICU for 1 week then in rehab for 3 weeks with full recovery except for mild residual pain/temperature deficit to his right side. He received his second hepatitis A vaccine 9/2 2005 with hepatitis B given 9/8/2005, 2/11/2006, 9/11/2006, and 3 influenza vaccinations (2005, 2006, 2007) with no adverse events. Symptoms: Gait abnormality, Weakness, Headaches, general, Inability to turn head (CN X1), Flu-like symptoms<96 hours, Pain.   4/14/09 Received medical records of 4/1/2009. FINAL DX: CVA/dissected cerebral artery Records reveal patient experienced flu-like symptoms after flu, hep A #1 & typhoid #2 vaccinations on 11/7/1997.  (Had received Td on 8/5/1997.)  Developed basilar HA 2 days s/p vax which increased over 10 days.  Seen in clinic & given muscle relaxer for muscle strain.  HA increased & meds changed w/complete resolution for 4 days.  Then on Thanksgiving day, after neck hyperextension became pale, uncoordinated, HA, unable to stand & assisted to floor.  Admitted to ICU x 1 wk w/dissected cerebral artery, then rehab x 3 wk w/full recovery except for mild residual pain/temperature deficit on right side.  Received subsequent vaccines w/o adverse events.					Y	7			U	08/05/1997	11/08/1997	95	Unknown no data available	UNK	UNK		None	None  PMH: HTN, GERD, high cholesterol.  Allergy: latex.			1						1	Artery dissection; Coordination abnormal; Discomfort; Dysstasia; Headache; Influenza like illness; Intensive care; Muscle strain; Muscular weakness; Neck pain; Pain; Pallor	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~1~UN~UN~HEP A (NO BRAND NAME)~1|TD~UNKNOWN MANUFACTURER~~UNK~UN~UN~TD ADSORBED (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~UN~UN~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0338849	04/03/2009	NM	0.6	0	.6	F	01/29/2009	Initial report received on 22 January 2009 from a health care professional.  A seven-month-old female patient with no past medical history, had received an intramuscular left thigh injection of ACTHIB, lot number UF442AA (sanofi pasteur SA lot number A0900-2), an intramuscular right thigh injection of FLUZONE (lot number UT2786GA), an intramuscular left thigh injection of PCV7, (lot number C73459, manufacturer Wyeth),  an intramuscular right thigh injection of PEDIARIX, (lot number AC21B137AA, manufacturer GlaxoSmithKline) and an oral dose of ROTATEQ, (lot number 0310X, manufacturer Merck) on 06 January 2009, and on the evening of vaccination, the patient developed diarrhea, vomiting, fever and decreased urine output.  The symptoms have not subsided and the patient has been urinating one time each day, vomiting after each feeding and had a fever of 101.6 (axillary).  The patient was seen in the emergency room and the physician's office and received corrective treatment with TYLENOL, PEDIALYTE and antidiarrheal therapies.  At the time of the report, the patient had not recovered.  Documents held by sender:  None				Y					N	01/06/2009	01/06/2009	0	Unknown	PVT	PVT			The patient had no illness at the time of vaccination and she had not been taking any concomitant medications.  The patient had no adverse events following previous vaccinations.		200900246	1						2	Diarrhoea; Oliguria; Pyrexia; Vomiting; Diarrhoea; No reaction on previous exposure to drug; Pyrexia; Urine output decreased; Vomiting; Diarrhoea; Pyrexia; Urine output decreased; Vomiting	RV5~MERCK & CO. INC.~0310X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B137AA~UNK~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~2|FLU3~SANOFI PASTEUR~UT2786G~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~SANOFI PASTEUR~A0900~UNK~ID~LL~HIB (ACTHIB)~2|PNC~PFIZER\WYETH~C73459~UNK~IM~LL~PNEUMO (PREVNAR)~2|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC121B137AS~3~UN~UN~DTAP + HEPB + IPV (PEDIARIX)~3|HIBV~SANOFI PASTEUR~UI4428A~2~UN~UN~HIB (ACTHIB)~3|PNC~PFIZER\WYETH~C73459~3~IM~UN~PNEUMO (PREVNAR)~3|RV1~GLAXOSMITHKLINE BIOLOGICALS~0310X~UNK~PO~MO~ROTAVIRUS (ROTARIX)~3	USA	Emergency room visit	Influenza
0343459	04/03/2009	AL	35.0			F	03/31/2009	After last flu shot experienced headache, dizziness + flu like symptoms.									Y					UNK	UNK						1						1	Dizziness; Headache; Influenza like illness	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0343465	04/03/2009	NC	58.0	58		M		None									Y	04/01/2009	04/01/2009	0		MIL	UNK		none	none			1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~U29498A~2~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0306736	04/04/2009	MO	75.0	75		U	04/04/2009	On Jan. 10th 1008-I had a flu shot-after my injection was swollen 30% more than normal-I had extreme pain and thought I had broken my wrist in my sleep-I had it xrayed at emergency and it showed neg. 18 hrs later my right wrist was swollen-about the same as my left wrist a few days earlier-my doctor diagnose my condition as reactive arthritis-for 53 years my business has been in upholstery-with no sign of ar until I had the flu shot-				Y				Y	N	01/10/2008	01/11/2008	1		UNK	UNK						1						3	Arthralgia; Arthritis reactive; Injection site swelling; Joint swelling; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA320AA~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~3	USA	Disabling	Influenza
0329210	04/04/2009	OH	50.0	50		F	04/04/2009	Patient had headache,left hemianesthesia and paresis with double vision within hours of the vaccine. Hospitalization, CT normal, CSF with <3 bands. October, 2008. 5 months later, she still had left eye pain and corneal anesthesia, photophobia, divergence insufficiency and skew deviation, left hemianesthesia with painful paresthesias. Exam remains consistent with ADEM: acute disseminated encephalomyelopathy.				Y				Y	N	10/09/2008	10/09/2008	0	CT of brain, spinal tap with CSF analysis, VER for vision, Could not have an MRI because of a former R stapedectomy.	UNK	UNK	None	None	prior R stapedectomy			1						2	Acute disseminated encephalomyelitis; CSF test; Diplopia; Eye pain; Headache; Hemiparesis; Lumbar puncture; Paresis; Photophobia; Scan brain; Visual evoked potentials	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Disabling	Influenza
0343510	04/05/2009	IN	69.0	69		M	04/05/2009	On 11/28/08, pt was in clinic and C/O welts on thigh; Shoulder reaction to flu shot; cough and sore throat. ONSET OF SYMPTOMS: Ongoing since flu shot on 10/14/08; cough and sore throat since 3 days. S/S: Welts to both thighs, left shoulder, and back; itching; swollen lips;  cough; sore throat.  ASSESSMENT: Vital signs noted.  Pt. presents to clinic with c/o above sx.  Pt. states that since receiving his flu shot, he has been experiencing these sx which last approx. 1 1/2 days, disappear, and then reoccur; itching but denies any pain; denies any SOB, chest pain, or throat swelling.  Pt. has not had a reaction to any other flu shot in the past.  Large circular, raised welts noted to bilateral upper thighs/hips, left side and shoulder; erythema noted to left shoulder.  Cough is noted as productive of white mucous.  Lung sounds clear bilaterally; respirations regular and non-labored; ears clear and WNL; nasal passages bright red with clear exudate; throat without swelling or erythema; no pain/tenderness noted with palpation to frontal sinuses or submandibular lymph nodes.  Pt. reports use of OTC Ibuprofen, Alka-Seltzer Cough and cold with some relief.   Pt was given Benadryl				Y					Y	10/14/2008	10/17/2008	3		PUB	PUB	HYDROCHLOROTHIAZIDE, SIMVASTATIN, IBUPROFEN, LYSINE	HYPERLIPIDEMIA, DJD, Erectile Dysfunction, Obesity, Hypertension, Colonic Polyps	NKA			1						1	Cough; Erythema; Immunisation reaction; Lip swelling; Oropharyngeal pain; Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881292P EXP 6/0~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0343511	04/05/2009	CA	36.0	36		M	04/05/2009	Patient was given scheduled vaccination doses of: Typhoid, Influenza, and Anthrax on 3/14/09. After about a week and a half later, the patient noticed some mild blistering and itchiness around and below the vaccination site. The blisters and itchiness continued to worsen and spread. Patient finally went to ER on 4/5/09 with purulent lesions that were on the lateral part of their right arm and extending from the deltoid to the forearm. ER diagnosed patient with, Cutaneous reaction to Anthrax vaccine and sent patient home with instructions to use hydrocortisone creme. After patient went to the ER, he came to see a military doctor. After our doctor saw the lesions, he commented that it could be a herpes zoster infection secondary to having the vaccines. He concurred with the hydrocortisone therapy. the patient wsa told to let the clinic know if there are any changes, to let us know right away.				Y					U	03/14/2009	03/24/2009	10		MIL	MIL	None	None	None			1						1	Herpes zoster; Injection site pruritus; Injection site vesicles; Purulence; Skin lesion	ANTH~EMERGENT BIOSOLUTIONS~FAV164~1~IM~RA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U2898FA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TYP~SANOFI PASTEUR~B04242~2~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0343523	04/05/2009	NV	40.0	40		M	04/05/2009	2-3 day after hives around vaccination site later and to this date muscle aches, joint pain and skin hypersensitivity.				Y					N	03/08/2009	03/10/2009	2		MIL	MIL						1						1	Arthralgia; Hypersensitivity; Injection site urticaria; Myalgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197AA~7+~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB640AA~1~UN~UN~HEP B (ENGERIX-B)~1	USA	Emergency room visit	Influenza
0337614	04/06/2009	AZ	34.0	34		F	04/06/2009	This report is to follow up on VAERS Report E-27729, submitted 1/16/09.  Patient contacted RN.  Patient stated The lump on my R arm and the rash on my torso from the pneumonia shot finally went away the week of 3/9/09. Reaction to the injection lasted > 8 weeks.				Y					Y	01/07/2009	01/07/2009	0		UNK	UNK						1						2	Body temperature; Chest X-ray normal; Injection site erythema; Injection site induration; Injection site mass; Injection site pruritus; Local reaction; Rash; Urticaria; Mass; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA168AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0981X~1~SC~RA~PNEUMO (PNEUMOVAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA168AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~2|PPV~MERCK & CO. INC.~0981X~1~SC~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0343532	04/06/2009	SC	8.0	8		M	04/02/2009	This non serious case was received on 24 February 2009 from a health care professional. A nine year old patient received the INFLUENZA vaccine (manufacturer and lot number not reported) on an unspecified date. On an unspecified date the patient was diagnosed with flu strain B. No further details were provided. Recovery status was not provided. Follow-up information received 24 March 2009 from a health care professional. Based upon this new information received, this case meets seriousness criteria and has been upgraded to serious. The patient received a left deltoid injection of FLUZONE SV 2008-2009 (route not reported), lot number U2828AA on 20 November 2008 and 96 days later, he developed Flu Strain B with symptoms of headache, stomach pain and fever on 24 February 2009. A rapid flu test had been performed in the doctor's office and TAMIFLU was prescribed as corrective treatment. The patient had no illness at the time of vaccination. At the time of the report, the patient's recovery status was unknown. According to the reporter, the patient had a past history of Flu at eight-years of age  following receipt of an unspecified INFLUENZA vaccine (manufacturer, lot number, route/site and date of administration not reported). No additional information was provided. List of Documents held by Sender: none.				Y					U	11/20/2008	02/24/2009	96	Not reported. From information received 24 March 2009, a rapid flu test was performed in the doctor's office.	PVT	PUB			Not reported. From information received 24 March 2009, the patient had received two doses of INFLUENZA vaccine in the past. The patient also had a past history of the Flu at eight years of age following receipt of an unspecified INFLUENZA vaccination.		200900751	1						1	Abdominal pain upper; Headache; Influenza; Influenza serology; Pyrexia	FLU3~SANOFI PASTEUR~U2828A~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0343581	04/06/2009	CT	14.0	14		F	04/06/2009	swelling pain of both knees. 4/13/09 MR and vax info received from PCP.  In for 14 yr WCC with normal exam 11/11/08. Vax given.  Returned 12/22/08 with c/o several day hx of cough, runny nose, ear pain, chest congestion and sore throat.  PE (+) for red throat, stuffy nose, few small nodes. Assess:  Asthma.  Pharyngitis. Returned 2/12/09 with c/o sore throat and cough, H/A, presyncope.  PE (+) for T=101.5'F, nasal congestion, pharyngeal erythema, shiners.  Assess:  Sinusitis.  Fever.  Pharyngitis.  Returned 2/17/09 with same c/o as 2/12/09.  Additionally, back pain with coughing. PE (+) for red throat, few nodes and stuffy nose. Sent for CXR. Assess:  Asthma.  Returned 3/30/09 with c/o knee pain and swelling x 5 months. No injury other than foot injury prior to that. PE (+) for swollen knees with fluid in joints. Assess:  joint pain and swelling.				Y					U	11/11/2008	11/18/2008	7	CBC, diff, sed rate, ANA ASO RF Lyme all normal. Labs:  Rapid strep (-).   Flu (-)  CXR WNL. MCV 29.3 (H).  RF (-). ESR 5. ASO 165 (H).  ANA (-).	UNK	UNK	Advair, Albuterol Singulair	Asthma, Foot injury	PMH:  asthma.  foot injury			1						1	Antinuclear antibody negative; Arthralgia; Borrelia burgdorferi serology negative; Full blood count normal; Joint swelling; Red blood cell sedimentation rate normal; Rheumatoid factor negative; Streptococcal identification test negative	FLU3~SANOFI PASTEUR~U2756AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0575X~3~IM~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2726AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B029AA~1~IM~LA~TDAP (BOOSTRIX)~1	USA	Emergency room visit	Influenza
0343598	04/06/2009	WA	60.0	60		F	04/06/2009	This case was reported by a consumer and described the occurrence of feels like having a heart attack in a 60-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline) and received Omeprazole. A physician or other health care professional has not verified this report. Concurrent medical conditions included severe allergies and high blood pressure. Concurrent medications included Lisinopril. In October 2008 the subject received unspecified dose of FLUARIX (unknown). The following day, the subject took Omeprazole. That same day, she experienced leg cramping. The leg cramping became worse as the days progressed and she soon developed a funny feeling in her chest and she felt that she was having a heart attack. The subject consulted a healthcare professional regarding the events. Medical attention was required at a doctor's office. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved.				Y					Y	10/01/2008	10/01/2008	0	UNK	PUB	OTH	LISINOPRIL	Allergy (NOS); High blood pressure	The subject had no reaction after her first flu shot and had no adverse reactions following previous vaccinations.		A0776925A	1						1	Chest discomfort; Muscle spasms	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0334209	04/07/2009	WA	74.0	74		M	12/08/2008	2-3 hours after dose, experienced syncope and became diaphoretic and weak. Drove self to local Ed and was admitted for cardiac evaluation. Outcome of work-up is unknown, however patient survived in good shape.					Y				U	11/06/2008	11/06/2008	0		PUB	OTH	Albuterol, Amlodipine, HCTZ, Insulin, Ipratropium, Mometazone, Miacin, Simvastatin	None	Hypothyroid, CAD, CVD, CKD, COPD, Hyperlipidemia, DM, HTN			1						2	Asthenia; Hyperhidrosis; Syncope	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA174AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~2	USA	Hospitalisation	Influenza
0343677	04/07/2009	NC	54.0	54		F	04/07/2009	11/4/08  Optic Neuropathy leading to severe loss of vision right eye.  Treated with high dose IV steroids with no benefit.  5/4/09 Received Optho Clinic consult of 12/30/2008. FINAL DX: AION right eye(anterior ischemis optic neuritis) Records reveal patient experienced sudden painless vision loss right eye on 11/2.  Exam revealed disc edema.  5/11/09 Received OPH office records DOS 11/4/08-12/1/09. FINAL DX: Anterior Ischemic Optic Neuropathy - Right Eye Patient noticed spot and pain in right eye.  Central vision loss. Right eye fundus elevation with telangiectatic vessels.   4/28/09 Received PCP medical records of 11/17/08-4/6/09. FINAL DX: ischemic optic neuropathy Records reveal patient experienced unilateral vision loss.  Had been diagnosed by outside MD & had PICC line placed for high dose steroids x 5 days.  Unilateral blindness remained despite steroids & was continued on oral antibiotics & steroids w/o resolution.  1/2/09 tripped & fell w/pain on right shoulder & ribs.  Dx w/rotator cuff bursitis & tx w/PT & meds. 5/12/10 Monocular blindness.				Y				Y	N	10/31/2008	11/04/2008	4	5/11/09 Received OPH office records DOS 11/4/08-12/1/09. LABS: Temporal artery biopsy WNL. MRI brain WNL.  Elevated C-reactive protein.  Negative Lyme disease titer.  LABS: WBC 17.2(H), neutros 87.5%(H), lymphs 5.6%(L), BUN 27(H).  ESR 9(N).CRP <0.3(N).  HgbA1C 6.2(N).  Lipid panel(H).  MRI 11/8 neg for MS.  Right shoulder & CXR WNL.	UNK	UNK	Effexor	None	Anxiety/depression  Medical records state PMH: allergic rhinitis; heartburn; menopause; tinnitus; acute bronchitis, anemia, epistaxis & OM resolved; appendectmy.			1						1	Blindness; Blindness unilateral; Nuclear magnetic resonance imaging normal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~U2828AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Disabling	Influenza
0331858	04/08/2009	NY	82.0			M	03/27/2009	Information has been received from an 82 year old male with atrial fibrillation, oedema, penicillin allergy and sulfanomide allergy who on 29-OCT-2008 was vaccinated with ZOSTAVAX, lot # was not reported. Concomitant therapy included influenza virus vaccine (unspecified), blood pressure and heart medication unspecified. The patient reported that he received the vaccine and 3 days later his physician prescribed him PREDNISONE, shortly after he started therapy with PREDNISONE, on 5-NOV-2008, he came down with shingles. The patient stated that the blister was very painful and spreading from the waist down his left leg to his toes. The blisters went away however the patient is still experiencing some urinary problems and a little bit of a rash on his left scrotum. The patient indicated that he also noticed that his atrial fibrillation has gotten worse. The outcome of shingles was improved. The patient sought unspecified medical attention. No further information is available.									N	10/29/2008	11/05/2008	7	None	OTH	OTH	PREDNISONE	Atrial fibrillation; Oedema; Penicillin allergy; Sulfanomide allergy			WAES0901USA03383	1						2	Atrial fibrillation; Condition aggravated; Herpes zoster; Pain; Rash; Urinary tract disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|VARZOS~MERCK & CO. INC.~~UNK~UN~UN~ZOSTER LIVE (ZOSTAVAX)~2	USA		Influenza
0343707	04/08/2009	MD	51.0	51		F	04/03/2009	Client reports pain & burning sensation to right upper arm since flu vaccination.  Severe pain started approximately 2 wks after administration.  She reports pain is better at times, then worse again.  She states it has affected her ROM to this arm, & can't lay on this side.				Y						11/04/2008	11/18/2008	14	None	OTH	PUB	Ibuprofen 800 mg prn; DILTIAZEN 249 mg approximately X day PO; TRIAMT/HCTZ, 37.5/25 mg approximately X day PO; PCN, 250mg; BID PO	None	Hypertension; Hx of Rheumatic fever; allergic to SULFA X CODEINE			1						1	Burning sensation; Joint range of motion decreased; Pain in extremity; Burning sensation; Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2810AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2810A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0343710	04/08/2009	NE	49.0	49		F	10/24/2008	Angloedema & swelling of uvula.				Y					Y	10/23/2007	10/25/2007	2	Etiology of allergic reaction unclear.	OTH	OTH	Vit B-12 injection	Environmental allergies				1						1	Angioedema; Enlarged uvula; Hypersensitivity	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0343726	04/08/2009	CA				U	04/03/2009	This case was received from a health professional on 26 March 2009, via another manufacturer (document number 45215838). A patient received Flu vaccine (manufacturer and lot number not reported) sometime in the past and subsequently experienced an anaphylactic reaction. No additional information was available.				Y										UNK	UNK					200901259	1						1	Anaphylactic reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0343737	04/08/2009	NY	8.0	8		F	03/19/2009	Whelps developed. Got in waiting area she began to break out with a pruritic rash and had difficulty breathing. 62.5 Solumedrol IM given, 0.2 Epinephrine SQ given, 25mg Benadryl IM given. After 10 minutes, VS remained stable and pt reported relief. Was followed up 3/13/09.									Y	03/04/2009	03/04/2009	0		PUB	PUB		None	At age 1 open heart surgery			1						1	Dyspnoea; Rash pruritic; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89983~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~MERCK & CO. INC.~AHAVB257AA~UNK~UN~RA~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~~UNK~UN~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0343746	04/08/2009	SC	32.0	32		F	04/08/2009	Edema of the tongue and throat. No acute respiratory distress. complained of mild itching around eyes and forehead. No erythema or rash noted in this area. Claritin 1 PO given.  Monitored for 1 hour.  Symptoms did not worsen. Discharged with two claritin tabs and instructed to take one on Thurs and Fri. AM.  Instructed to go to nearest ER if symptoms worsen.									Y	04/08/2009	04/08/2009	0		PUB	PVT	None	No	None Reported			1						1	Eye pruritus; Pharyngeal oedema; Pruritus; Tongue oedema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89297~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0343761	04/08/2009	DC	62.0	62		F	04/08/2009	Patient is a 62 year old male and recieved the flu vaccine on 1/12/09. He reported a history of Diabetes. He was recovering from a mild upper respiratory ailment and his oral temp was 98.4   No problems initially followed the vaccine. I saw the patient the weeks following the vaccine but he voiced no complaints. The school staff notified me in early March 2009 that patient had a diabetic stroke in late February 2009 and was hospitalized. I talked to the patient by phone on 4/2/09 and he told me he has suffered a stroke on the left side of his brain that caused weakness of the right side of his body.  4/20/09 MR received for DOS 2/25-3/06/2009 with D/C DX: Acute L Subcortical Ischemic stroke, DM2, high choleterol, High BP, hx GERD and hypokalemia.  Pt presented with 1 day hx of R sided weakness and numbness as well as heaviness in the R leg.  Attmpted to walk but fell, now with slurred speech. PE (+) for mild facial droop, decreased sensation, and R arm weakness.  Some improvement by d/c to rehab.				Y	Y	11			U	01/12/2009	02/24/2009	43	Labs and diagnostics:  MRI brain (+) for infarct. Head CT (+) for infarct, ALT 90, glucose 176, carotid dopplers (-) for stenosis, (+) for atherosclerosis. 2D echo with EF 55-60%	UNK	UNK		Mild cold	Diabetes PMH:  HTN, DM2, GERD, high cholesterol			1						1	Hemiparesis; Cerebrovascular accident	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA364AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA364AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Hospitalisation	Influenza
0343765	04/08/2009	WA	31.0	31		F	04/08/2009	WITHIN 48HRS DEVELOPED LOCALIZED REDNESS AND SWELLING IN RIGHT ARM, FEVER, MALAISE, MYALGIAS. REACTION OCCURED AT THE SITE OF PNUEMOVAX INJECTION									U	04/06/2009	04/07/2009	1		UNK	UNK		NONE	PHENERGAN, MORPHINE			1						1	Injection site erythema; Injection site swelling; Malaise; Myalgia; Pyrexia	FLU3~SANOFI PASTEUR~U2829AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~ATTBVB703AA~1~IM~LA~HEP B (ENGERIX-B)~1|PPV~MERCK & CO. INC.~1162X~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AL52B039~UNK~IM~RA~TDAP (BOOSTRIX)~1	USA		Influenza
0343768	04/08/2009	CA	20.0	20		M	04/08/2009	Pt received immunizations (FLUMIST, HepA/B, Meningococcal, MMR, Pneumococcal) on 2/18/09. Per the pt he received these vaccinations on 2/19 or 2/20/09 (he arrived at Boot Camp on 2/18/09). On 2/27/09 the pt noted a dry cough. On 3/2/09 the pt reported sick. Call with a productive cough and rhinnorhhea. He denied sore throat, earache, fever, N,V, diarrhea, headache or decreased appetite. He was treated with SUDAFED, MOTRIN and MUCINEX. Also, noted at the visit was paronychia middle finger/bilateral which was treated with KEFLEX. On 3/4/09 the pt noted numbness of his right forearm which progressed to his right hand/fingers then to his right shoulder by 3/6/09. He had minimal weakness of his UE. By 3/6/09 he also noted numbness of his left arm/hand/fingers/shoulder and weakness in his lower legs. On 3/7/09 the pt also noted numbness from his anterior neck to his chest and his feet felt cold and tingly. The numbness radiated to his back on 3/8. By 3/9/09 the pt was barely able to move his legs, he had problems with balance and his arms were weak. He was seen in Sick Call and diagnosed with and treated for dehydration. By 3/12/09 the pt was worse; he was having hard time walking independently; his UE were weak; he hands and feet were completely numb. The pt states he was sent to the ER and admitted to hospital on 3/13/09. Tx with IVIG for 3days and PT. Discharged on 3/20/09. 4/3/09 residual numbness on bilateral great toes.   4/15/09 Received medical records of 3/16-3/31/2009. FINAL DX: Guillain-Barre syndrome Records reveal patient experienced dry cough on 2/27/09, then developed productive cough & rhinnorhea, seen in clinic, dx w/URI & tx symptomatically.  Also had paronychia & tx w/oral antibiotics.  Patient noted numbness UEs beginning 3/4/09 & progressing to include LBP, weakness & tingling of LEs.  By 3/9 barely able to move legs.  Seen in clinic & dx w/dehydration.  By 3/12 had difficulty walking, balance disturbance & hand/feet were completely numb.  Seen in ER & admitted 3/13-3/20/09.  Tx w/IVIG x 3.  D/C to home w/PT & Neuro clinic f/u.					Y	15			U	02/18/2009	03/04/2009	14	13 Mar 2009 2221, Mycoplasma sp. Ab IgG, 3.07 (H); Mycoplasma sp. Ab IgM, 166; Streptococcus pneumoniae Ag URINE, NEGATIVE; Legionella sp. Ab Serum, 1:128; 13 Mar 2009 2345, Blood culture, NO GROWTH AFTER 48 HRS. NO GROWTH IN 5 DAYS; 14 Mar 2009 0026, Drug Screen Urine; Amphetamines, NEGATIVE; Benzodiazepines, NEGATIVE; Cocaine, NEGATIVE; Opiates, NEGATIVE; Cannabinoids, NEGATIVE; Barbiturates, NEGATIVE; Phencyclidine, NEGATIVE; 14 Mar 2009 0258, Sputum, MANY GRAM POSITIVE COCCI; MANY GRAM NEGATIVE RODS; 14 Mar 2009 0302, Influenza Virus A+B Ag, NEGATIVE; 14 Mar 2009 0302, Adenovirus Ag, NEGATIVE; 14 Mar 2009 0302, Respiratory Syncytial Virus Ag, NEGATIVE; 14 Mar 2009 0302, Parainfluenza Virus, NEGATIVE; 14 Mar 2009 0325, Specimen: Throat BACTERIOLOGY RESULT, NO BETA HEMOLYTIC STREPTOCOCCI ISOLATED; 14 Mar 2009 0325, Influenza A+B Virus Ag, NEGATIVE; 14 Mar 2009 0458, Creatine Kinase MB Panel: Creatine Kinase MB PLASMA, 7.2 U/L; Creatine Kinase PLASMA, 374 IU/L; Creatine Kinase MB/Creatine Kinase Total, 1.9; 14 Mar 2009 0503, Hepatitis Virus Panel: Hepatitis B Virus Surface Ag SERUM, NON-REACTIVE; Hepatitis B Virus Core Ab SERUM, NON-REACTIVE; Hepatitis C Virus Ab SERUM, NON-REACTIVE; 14 Mar 2009 0810 CBC: Hemoglobin, 13.6 (L) g/dL; Hematocrit, 39.8 (L) %; WBC, 7.0 x 10(3)/mcL; RBC, 4.36 (L) x10(6)/mcL; Neutrophils, 4.4 x 10(3)/mcL; Lymphocytes, 26.6%; Lymphocytes, 1.9 x10(3)/mcL; Monocytes, 7.6%; Monocytes, 0.5x10(3)/mcL; Eosinophils, 2.3%; Eosinophils, 0.2x10(3)/McL; Basophils, 0.4%; Basophils, 0.0x10(3)/mcL; Platelets, 303 mcL; MCHC, 34.2g/dL; MCH, 31.2pg; MCV, 91.3 fL; RDW CV, 12.3%; MPV, 7.5 fL; Neutrophils, 63.1%; 14 Mar 2009 Liver Function Panel: Bilirubin, 0.2mg/dL; Bilirubin Direct, <0.2mg/dL; Protein, 6.3 (L) g/dL; Albumin, 3.3 (L) g/dL; Alkaline Phosphatase, 75U/L; Alanine Aminotransferase, 15 (L) U/L; Aspartate Aminotransferase, 24U/L; Lactate Dehydrogenase, 134 (L)U/L; Protein Electrophoresis Site/Specimen 16 Mar 2009 0838, Albumin SERUM, 2.9 (L) g/dL; Alpha-1-Globulin SERUM, 0.2G/dL; Alpha-2-Globulin SERUM, 0.9 g/dL; Beta-Globulin SERUM, 1.0 g/dL; Gamma-Globulin SERUM, 1.3 g/dL; Pathologist Review SERUM; 1. HYPOALBUMINEMIA. 2. NO MONOCLONAL PROTEINS ARE IDENTIFIED BY IMMUNOFIXATION ELECTROPHORESIS; 3/13/09, CSF cell count and diff WBC, 2; RBC, 237H; POLYS, 15%; LYMPH, 70%; MONOS, 15%; CSF GLUCOSE, 67; CSF PROTEIN 48 H; CSF CULTURE, NO CELLS; NO ORGANISM; 13-Mar-2009 11:06, CT, L-SPINE (W/O CONTRAST): IMPRESSION: ENDPLATE IRREGULARITIES PREDOMINANTLY INVOLVING SUPERIOR ENDPLATE OF T12 AND THE INFERIOR ENDPLATE OF T10, WHICH ARE LIKELY CHRONIC IN NATURE, AND POSSIBLE CONGENITAL IN ETIOLOGY. NO EVIDENCE OF ACUTE FRACTURE OR SPINAL CANAL OR NEURAL FORAMINAL COMPROMISE. 13-Mar-2009 18:35 CT, T-SPINE (W/O CONTRAST): IMPRESSION: ENDPLATE IRREGULARITIES PREDOMINANTLY INVOLVING SUPERIOR ENDPLATE OF T12 AND THE INFERIOR ENDPLATE OF T10, WHICH ARE LIKELY CHRONIC IN NATURE, AND POSSIBLE CONGENITAL IN ETIOLOGY. NO EVIDENCE OF ACUTE FRACTURE OR SPINAL CANAL OR NEURAL FORAMINAL COMPROMISE; 13-Mar-2009 10:59 MRI, BRAIN (W W/O CONTRAST): IMPRESSION: 1. UNREMARKABLE MRI EVALUATION OF THE BRAIN. 2. PAN SINUS MUCOSAL THICKENING WITH AIR-FLUID LEVEL IN THE RIGHT MAXILLARY SINUS, WHICH MAY REPRESENT A DEGREE OF ACUTE SINUSITIS. 3. ENDPLATE DEFORMITIES OF T10 AND T12 ARE LIKELY CONGENITAL IN ETIOLOGY GIVEN THE LACK OF EDEMA SIGNAL AND MORPHOLOGIC APPEARANCE. 4. NO ABNORMAL CORD SIGNAL OR ANATOMIC COMPROMISE; 3/13/09 LUMBAR SPINE SERIES: IMPRESSION: 1. AGE INDETERMINATE ANTERIOR WEDGE COMPRESSION DEFORMITY OF T12. 2. L5 PARS INTERARTICULARIS DEFECT ON THE LEFT; 3/13/09. HEAD CT: IMPRESSION: 1. NO EVIDENCE OF ACUTE INTRACRANIAL HEMORRHAGE OR MASS. 2. SINIFICANT DISEASE OF THE SINUSES; 3/13/09. THORACIC SPINE SERIES: IMPRESSION: FINDINGS CONCERNING FOR T12 COMPRESSION DEFORMITY OF UNCERTAIN CHRONICITY. THIS IS INCOMPLETELY EVALUATED. RECOMMENDED CT OF THE THORACIC SPINE FOR FURTHER EVALUATION.  LABS: EMG/NCS abnormal w/diffuse, motor greater than sensory demyelinating polyradiculoneuropathy of UE & LEs.	UNK	UNK	None	None	Environmental allergies  Family hx: bipolar.			1						1	Alanine aminotransferase normal; Alpha 1 globulin normal; Alpha 2 globulin normal; Aspartate aminotransferase normal; Balance disorder; Basophil count decreased; Basophil percentage; Beta globulin normal; Bilirubin conjugated; Blood albumin decreased; Blood alkaline phosphatase normal; Blood bilirubin normal; Blood creatine phosphokinase MB normal; Blood creatine phosphokinase normal; Blood culture negative; Blood lactate dehydrogenase normal; CSF culture negative; CSF glucose normal; CSF lymphocyte count normal; CSF monocyte count; CSF polymorphonuclear cell count increased; CSF protein increased; CSF white blood cell count negative; Computerised tomogram abnormal; Cough; Culture throat negative; Dehydration; Drug screen negative; Eosinophil count normal; Eosinophil percentage; Gait disturbance; Gram stain positive; Guillain-Barre syndrome; Haematocrit decreased; Haemoglobin decreased; Hepatitis B antibody negative; Hepatitis B surface antigen negative; Hepatitis C antibody negative; Hypoaesthesia; Hypokinesia; Immunoglobulins normal; Influenza serology negative; Legionella serology; Lymphocyte count normal; Lymphocyte percentage; Mean cell haemoglobin concentration normal; Mean cell haemoglobin decreased; Mean cell volume normal; Mean platelet volume normal; Monocyte count normal; Monocyte percentage; Muscular weakness; Mycoplasma serology positive; Neutrophil count normal; Neutrophil percentage; Nuclear magnetic resonance imaging brain abnormal; Paraesthesia; Paronychia; Peripheral coldness; Platelet count normal; Productive cough; Protein total decreased; Red blood cell count decreased; Red blood cells CSF positive; Red cell distribution width normal; Respiratory syncytial virus test negative; Rhinorrhoea; Spinal X-ray abnormal; Sputum culture positive; Streptococcal identification test negative; Virus serology test; White blood cell count normal	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB155AA~UNK~UN~UN~HEP A + HEP B (TWINRIX)~1|MMR~MERCK & CO. INC.~1639X~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|MNQ~SANOFI PASTEUR~U2843AA~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PPV~MERCK & CO. INC.~1667U~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0344717	04/08/2009		2.0	2	.3	M	04/07/2009	Information has been received from a physician concerning a young child who was vaccinated with a dose of PROQUAD (Merck). Subsequently, within 24 hours after receiving the vaccination, the patient experienced a seizure. The outcome was reported as recovered. It was unspecified if medical attention was sought. No product quality complaint was involved. Follow-up information has been received concerning a 27-month-old male who on 17-Oct-2007 was vaccinated with a dose of MMR II (lot # 0867F) previously reported as PROQUAD (Merck). Secondary suspect vaccination included a dose of PEDVAXHIB (lot # 02789, manufacturer unknown). Concomitant medications included a dose of DTAP and INFLUENZA virus vaccine (unspecified). On 18-Oct-2007, the patient had fever, chills, lethargy and a seizure and was sent to the ER. The patient was given two doses of ATIVAN in the ER to stop the seizure. The patient's discharge diagnosis included atypical febrile seizure, upper respiratory seizure, right otitis media, and developmental delay. The patient was given antibiotics for the otitis media. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.				Y					Y	10/17/2007	10/18/2007	1	Unknown	OTH	OTH			Unknown		WAES0803USA02373	1						1	Chills; Convulsion; Developmental delay; Febrile convulsion; Lethargy; Otitis media; Pyrexia	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~MERCK & CO. INC.~~UNK~UN~UN~HIB (PEDVAXHIB)~1|MMR~MERCK & CO. INC.~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0345488	04/08/2009	CO	65.0			F	03/27/2009	Information has been received from a 65 year old female registered nurse, who is the consumer, with hypersensitivity and allergic reaction to antibiotics and a history of flu which she had on October 2008, who on 26-NOV-2008, a day before thanksgiving was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot# not provided). Concomitant therapy included influenza virus vaccine (unspecified) and glucosamine sulfate (unspecified). On 26-NOV-2008 the patient experienced rash above the belt buckle. On approximately 27-NOV-2008 the patient's rash appeared across her abdomen up her left side and across the back of her rib cage. The consumer is unsure if the rash was caused from ZOSTAVAX (Oka/Merck). The consumer saw her physician who gave her prednisone and BENADRYL to help with the rash, which she described as blotchy red dots like measles, since she could not sleep. No lab diagnostics studies performed. After two doses of prednisone her rash went away. The consumer reported that she also had a cold that she developed on 24-DEC-2008, Christmas eve, and she had an itchy throat, breathing difficulties and chest tightness. At the time of this report the patient had recovered. No further information is available.				Y					Y	11/26/2008	11/26/2008	0	None	OTH	OTH	glucosamine sulfate	Hypersensitivity; Allergic reaction to antibiotics	Flu		WAES0901USA01639	1						1	Chest discomfort; Dyspnoea; Insomnia; Rash erythematous; Rash macular; Throat irritation	FLUX~UNKNOWN MANUFACTURER~~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~UN~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0345620	04/08/2009	FL	59.0	59		F	03/27/2009	Initial information has been received from an office coordinator and follow up information has been received from a physician concerning a 59 year old female patient maintained on unspecified hormone replacement therapy with hypothyroidism and sulfonamide allergy and a history of hormone replacement therapy who on 16-OCT-2007 was vaccinated subcutaneously in her left deltoid area with a single dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included influenza virus vaccine (unspecified). On an unspecified date the patient experienced shingles on the right trunk section of her body and some itchiness but it was not painful. The patient was prescribed with ZOVIRAX one tablet five times a day to treat her symptoms. It is unknown if the patient recovered. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain. Follow-up information has been received from a physician concerning the patient with latex allergy who on 09-OCT-2007 (originally reported as 16-OCT-2007) was vaccinated subcutaneously in her left deltoid area with a single dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included CHANTIX. On 17-DEC-2008 the patient developed herpes zoster with itching, pain. There was no recent exposure to chickenpox or herpes zoster. The sample of the lesion was collected on 18-DEC-2008. The source of the specimen was vesicular zoster rash, number of lesions was not specified but there were 6 linear patches noted. A photo of the lesions was taken. At the time of reporting the patient had not recovered. Follow-up information has been received from a physician. The sample was taken from a vesicular lesion and there was erythema. Date of PCR analysis was 19-DEC-2008. VZV DNA was amplified and it identified VZV WILD TYPE STRAIN from an adequate specimen. No further information is available.				Y					N	10/09/2007	10/09/2007	0	VZV strain, 12/19/08, VZV WILD TYPE STRAIN	OTH	OTH	CHANTIX	Hypothyroidism; Hormone replacement therapy; Sulfonamide allergy; Latex allergy			WAES0812USA03704	1						1	Erythema; Herpes zoster; Pain; Pruritus; Rash vesicular; Varicella zoster virus serology positive	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0343788	04/09/2009		60.0			F	04/08/2009	Information has been received from a registered pharmacist concerning a now 66 year old female who in approximately 2003 about 4 to 6 years ago, was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included influenza virus vaccine (manufacturer unspecified). The patient informed the pharmacist that she developed GUILLAIN-BARRE syndrome after getting the flu shot about 4 to 6 years ago. The patient's doctor told her that she could not get more flu shots. On an unspecified date, the patient recovered from GUILLAIN-BARRE syndrome. The patient consulted with the pharmacist and sought unspecified medical attention. Upon internal review, GUILLAIN-BARRE syndrome was considered to be other important medical event. Additional information has been requested.									Y				Unknown	OTH	OTH	Unknown		Unknown		WAES0904USA00186	1						1	Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~UN~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0343790	04/09/2009	MO	49.0	49		F		When the rib cracked went to doctor. She prescribed pain pills, week later it went popped again. Years went by without problems, breast cancer showed up 2007. Went for chemo-radiation treatment. The rib acted up and has ever since.  4/29/09 Received PCP medical records of 9/2003-3/2009. FINAL DX: Type II DM; HTN; hyperlipidemia; hypothyroidism; right breast ductal carcinoma in situ stage 1; arthropathy Records reveal patient stated in 9/07 breast cancer was very small, surgically removed & no chemo or rad tx needed then started chemo 10/07.			Y						N	10/01/2003			Test CT-CT abdomen Oct. 17-2006 w/wo   LABS:breast biopsy c/w cancer	PVT	PVT	AVAPRO; Insulin; EXTRADIOL; ALLEGRA D	cracked rib happen after four or five days later	Brice Windsor  PMH: IDDM, asthma, URI, ganglion cyst, diabetic neuropathy, DKA & hypoglycemia, on HRT, cystitis, seasonal allergies, allergic rhinitis, GERD, endometriosis, HTN, hyperlipidemia, stress IBS, cellulitis, candidiasis intertrigo, strep throat, lumbago, atherosclerosis, obesity, Vit D deficiency, .  Homeless & family stressors. Family Hx: CAD, DM, cancer.	~Influenza (Seasonal) (no brand name)~UN~0.00~Patient		1						1	Breast cancer; Chemotherapy; Computerised tomogram; Pain; Radiotherapy; Rib fracture	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0343824	04/09/2009	FL	44.0	44		F	04/09/2009	Reports felt woozy,dizzy when got home. approx 1 1/2 hr later had some difficulty breathing along with burning sensation of face and eyes. did not call or seek care at that time. Went to school health nusre where she works next am:continued with above symptoms, along whith heart racing and rising BP; EMT called went to ER				Y					Y	03/18/2009	03/18/2009	0	DR at ER told me I was allergic to Flu vaccinetx with prednisone and pepsid- found allergic to pepsid see allergies below. stopped both tx and did not seek further care.	PUB	PUB		NONE	Per vaccinee:allergy to codiene, Morphine,oxycodone,sulfa. Reports swelling of lips cheeks and tongue after 1 1/2 day of pepsid			1						1	Allergy to vaccine; Blood pressure increased; Burning sensation; Dizziness; Dyspnoea; Eye irritation; Palpitations	FLU3~SANOFI PASTEUR~U2811AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1648X~UNK~IM~LA~HEP B (RECOMBIVAX HB)~1	USA	Emergency room visit	Influenza
0343857	04/09/2009	CA	33.0	33		M	04/09/2009	Received vaccination on 3/31/09:  TDAP and TYPHOID right arm, FLUMIST and AVA #4 left arm.  On 1 April 09 pt noted a 3 circle of redness and swelling around the AVA injection site.  His pain was a 3-4/10.  He thought he might have a slight fever and that his lymph nodes on the left side of his neck were swollen.  The pt went to MSC on 4/2/09.  His temp was recorded as 100.1.  He continued with redness and swelling around the injection site left arm and complained of generalized joint pain (esp his hips) and a low grade headache.  He was prescribed MOTRIN and TYLENOL #3.  On 4/3/09 his joint pain was improved, but the pain in his left arm was worse as was the redness and swelling.  He was prescribed KEFLEX 500mg qid.  Today the pt's pain level is a 2/10, there is decreased swelling and redness at the site.  The pt states for the last 48 hours he has had intermittent left shoulder pain followed by a cold numb feeling in his arm and left hand (all digits).  These symptoms can last for several minutes to one hour.  The pt was prescribed PREDNISONE 60mg X5 days with a 10mg taper per day.  On 04/9/09 the pt was reexamined.  He had no more left shoulder pain or left hand numbness.  The left arm swelling was completely resolved as was 90% of the erythema.  Symptoms: Pain, Numbness, Erythema, Edema @ injection site 50-120mm, Pain.										03/31/2009	04/01/2009	1	none	UNK	UNK	ALLOPURINOL	None	gout; bilateral shoulder bursitis			1						1	Arthralgia; Body temperature increased; Feeling cold; Headache; Hypoaesthesia; Injection site erythema; Injection site oedema; Injection site swelling; Lymphadenopathy; Musculoskeletal pain; Pain; Pain in extremity	ANTH~EMERGENT BIOSOLUTIONS~FAV177~UNK~UN~LA~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TDAP~SANOFI PASTEUR~C3028BA~UNK~UN~RA~TDAP (ADACEL)~1|TYP~SANOFI PASTEUR~B0424~UNK~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0293284	04/10/2009	KY	62.0	62		F	10/12/2007	10/08/07 sore, scratchy throat- 10/09/07 (3:00pm) fever 103, chills, myalgia, confusion					Y	3			U	10/04/2007	10/08/2007	4	spinal tap	UNK	UNK	none	none	none			1						2	Chills; Confusional state; Lumbar puncture; Myalgia; Oropharyngeal pain; Pyrexia; Throat irritation	FLU3~SANOFI PASTEUR~U2442AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0340892	04/10/2009	TX	63.0	63		M	04/10/2009	Patient complaint: 64 yr old male presents with c/o having a flu and  pneumonia injections 2 weeks ago and now has soreness, redness, and skin peeling. He states that originally the red was approx 8 1/2 inches from top area to bottom area. The area was tender to touch and his temp got up to 102. A. Pt has hardness approx 3cm in diameter that is lt pink with darker pink in middle.  No peeling visible now. P. Pt instructed to take Motrin or Tylenol for the pain and inflammation.									Y	10/28/2008	10/30/2008	2		MIL	PUB						1						2	Body temperature increased; Injection site erythema; Injection site induration; Injection site pain; Injection site warmth; Skin exfoliation; Body temperature increased; Erythema; Induration; Inflammation; Pain; Skin discolouration; Skin exfoliation; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89297~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~09798~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89297~5~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~09798~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0343927	04/10/2009	KY	1.0	1	.0	M	12/31/2007	low appetite, fever, seizure				Y					N	12/27/2007	12/28/2007	1	MTI, EEG	PVT	UNK	none	none	laryngomalacia-resolved			1						1	Anorexia; Convulsion; Electroencephalogram; Nuclear magnetic resonance imaging; Pyrexia	FLU3~SANOFI PASTEUR~UT2474EA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~04940~1~IM~LL~HEP A (VAQTA)~1|PNC~PFIZER\WYETH~B08702H~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0343928	04/10/2009	KY	11.0	11		M	12/21/2007	urticaria- abdomen/chest/lumbar				Y					Y	11/21/2007	11/21/2007	0	none	PUB	PVT	none	nasal congestion	none			1						1	Urticaria	FLU3~SANOFI PASTEUR~U2511AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0343929	04/10/2009	OH	36.0	36		M	12/07/2007	Intermittent shooting pains in right arm, soreness at injection site, no redness or swelling at site									U	11/05/2007	11/06/2007	1		PUB	PUB						1						1	Injection site pain; Pain	FLU3~SANOFI PASTEUR~U2511AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0343943	04/12/2009	NJ	88.0	88		M	04/12/2009	ulcerated left upper arm				Y					U	10/25/2008	01/26/2009	93		UNK	UNK			none			1						1	Skin ulcer	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89297~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0343944	04/12/2009	NC	66.0	66		F	04/12/2009	Feaver, caugh,weak, breathing problems				Y					Y	10/21/2008	11/06/2008	16	X ray, CT Scan, Lab, Bronoscpy	UNK	UNK						1						1	Asthenia; Bronchoscopy; Computerised tomogram; Cough; Dyspnoea; Laboratory test; Pyrexia; X-ray	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0343993	04/13/2009	CA				U	04/08/2009	This serious case was received on 01 April 2009 from a health care professional. An approximately 3 week old patient (gender not specified) received FLUZONE SV 2007-2008 (lot number not reported) transplacentally on 15 November 2007. The patient was born on 14 May 2008 at a gestational age of 39.7 weeks. Apgar score at one minute and five minutes were both 9. On 07 June 2008 the patient had pyloroplasty for pyloric stenosis. The child recovered from the surgery. On 13 November 2008 the patient was diagnosed with pneumonia. No further information was reported. This case has the same reporter as case number 2009-01354.									Y		06/07/2008		none reported	OTH	OTH			not reported		200901355	1						1	Maternal drugs affecting foetus; Pneumonia; Pyloric stenosis; Surgery	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0343994	04/13/2009	PA				M	04/08/2009	Initial report received 01 April 2009 from a health care professional, who is also the patient. According to the reporter, they developed the flu an unspecified amount of time after they had received an influenza vaccination (manufacturer and lot number not reported) during the same influenza season. No laboratory or diagnostic testing had been performed. Information pertaining to the event symptoms, dates of onset, duration and severity were not reported and the patient declined to provide additional information. The patient's recovery status was not reported. Documents held by sender: None.				Y					U				No testing had been performed.	UNK	UNK			Not reported		200901356	1						1	Influenza	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0344011	04/13/2009	CO	24.0	24		F	04/03/2009	Seizure - Full clonic/tonic 1 hr 45 minutes after receiving routine immunizations - Family describes today's episode the same as in the past (same seizure activity). Ambulance called to take Pt. to hospital because she hit her head on wall at onset of seizure.  4/14/09 Received Clinic & ER medical records for 4/1/09 & 4/3/09. FINAL DX: Seizure disorder Records reveal patient experienced unwitnessed siezure in clinic lobby, hit head on wall, tonic clonic movements of arms & stiff legs x approx 15 secs.  Afterward was back to baseline of minimally responsive & nonverbal per family who also states this episode is her typical seizure.  Had been out of meds x 3 wks since arrival from out of country.  PE revealed contracted UE & LE, multi dental caries.  Tx w/meds & referred to neuro on d/c to home.					Y	2			Y	04/03/2009	04/03/2009	0	LABS: H/H 8.8/28.4(L), plts 574(H).  CT head WNL.	PVT	PUB	Was on Phenobarbital 30 mg TID up until 3 wks ago (ran out of med)	severe developmental delay (from birth); seizures - beginning at age 2 yrs	Developmental delay and seizures (epilepsy); severe mental retardation  PMH: severe epilepsy since age 2 w/last seizure 2008, BMI 13, decreased vision, stool & urine incontinence, malaria 2008.			1						1	Condition aggravated; Convulsion; Grand mal convulsion; Head injury	FLU3~SANOFI PASTEUR~U2968AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0035Y~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR I)~1|TD~SANOFI PASTEUR~U2077BA~1~IM~LA~TD ADSORBED (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~0060Y~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0344019	04/13/2009	UT	45.0	45		F	03/30/2009	Pt came into clinic after shots for immigration.  She was given a Tdap and an MMR in left arm.  Six days later she came back to clinic with a bruised and swollen arm with a large red ring around it.  She was sent to see a doctor.				Y					Y	03/20/2009	03/26/2009	6	None	PUB	PUB		None	None			1						1	Contusion; Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~2393~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~2470~1~UN~RA~HEP B (FOREIGN)~1|MMR~MERCK & CO. INC.~2495~1~UN~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|TDAP~SANOFI PASTEUR~2512~1~UN~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0344030	04/13/2009	NC	33.0			F	04/08/2009	Non stated.														UNK	UNK						1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88907~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0344058	04/13/2009	KY	1.3	1	.3	M	04/09/2009	Seen 4/9/09 with small induration and some redness. Advised to put cold compress + should resolve in a few day by doctor.									U	04/07/2009	04/08/2009	1		OTH	PUB	None	No	None			1						1	Erythema; Induration	DTAP~SANOFI PASTEUR~C3083AA~4~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U2761AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~C99082~4~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0344092	04/13/2009	OK	42.0	42		F	04/13/2009	numbness in fingers/hands/feet approximately 3 weeks post flu shot.  Diagnosed with GBS.  4/27/09 Received hospital medical records of 11/24-12/1/2008. FINAL DX: Guillain-Barre; possible neurogenic bladder; e. cole UTI Records reveal patient experienced rapid onset of progressive weakness of LEs & UEs.  Had been out of the country x 3 wks & during return flight home developed HA, hand weakness, difficulty walking, numbness of feet, balance difficulty, pain of upper back, glutes & thighs .  Neuro consult done.  Reflexes diminished.  LP done & tx w/IVIG x 5 days w/some improvement.  Had neurogenic bladder requiring Foley cath.  Had continued neuropathic pain of right side.  Improved slowly & d/c to inpatient rehab.					Y	30			U	10/25/2008	11/15/2008	21	LABS: CSF: WBC 1, RBC 2, protein 37.5, glucose 63.  Potassium 3.2(L), sodium 133(L).  ANA(+), SSA 193(H).  WBC 12.8(H), ANC 8.3(H).  ALT 42(H).  UA abnormal, c/s (+).  EKG abnormal w/ nonspecific t-wave changes & prolonged QT.  MRI c-spine abnormal w/stenosis, spurring & possible thyroid cyst.  EMG abnormal w/predominantly motor neuropathy.	UNK	UNK		unknown	NKDA  PMH: DDD c-spine.  Endometriosis w/surgery.  Family hx: DM.			1						1	Guillain-Barre syndrome	FLU3~GLAXOSMITHKLINE BIOLOGICALS~192BAA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation	Influenza
0344127	04/14/2009	PR	31.0	31		F	04/14/2009	PATIENT REFERS HAVING A RASH ALL OVER THE BODY AND A RED EYE.				Y					Y	11/28/2008	12/02/2008	4	NONE	PUB	PVT		NONE				1						1	Ocular hyperaemia; Rash generalised	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89992~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0344129	04/14/2009	ND	63.0	63		M	04/14/2009	Developed nausea and vomiting after leaving clinic.  Resolved day following injection.  Reported soreness at injection site.  Red skin discoloration 4 x 4 inch in size with multiple interrruptions in distribution.									Y	12/03/2008	12/03/2008	0		PVT	PVT	Nexium, toprol XL, benicar HCT, combivent inhaler.		Benadryl- insomnia, hypertension, GERD		ND-09-04	1						1	Injection site pain; Nausea; Skin discolouration; Vomiting	FLU3~SANOFI PASTEUR~U2803AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1163X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0344131	04/14/2009	CA	67.0	67		F	04/14/2009	Patient developed Guillan Bare syndrome, 4 days after the vaccination.  4/22/09 MR received for DOS 10/29-11/17/2008 with D/C DX:  Guillain-Barre Syndrome.  Non-Hodgkin's Lymphoma controlled with chemotherapy and radiation.  Pancytopenia r/t tx for Hodgkin's Lymphoma.  Pt initially presented to PCP on 10/13/08 with c/o L arm weakness x 8 days. Pt had recently been treated with radiation to the L axilla. Initially thought to be a radiation plexitis. Some improvement in pain level with steroids, none in weakness. Returned 10/28/08 with c/o profound lower and upper extremity weakness.  By 10/29/08 unable to stand or walk.  Admitted after (+) EMG/NCS in office. PE (+) for weakness in upper and lower extremities, areflexia, and brisk knee jerks. Tx with plasmapheresis w/o improvement. Developed bladder retention with Foley cath insertion. Unable to use IVIG due to low IgA level. Some improvement by d/c to rehab on 11/17/08.  4/28/09 Received Neuro consult of 10/13/08-2/19/09. FINAL DX: acute demyelinating inflammatory polyneuropathy, slowly resolving Records reveal patient experienced abrupt onset profound weakness of left arm x 1 wk prior to initial eval & beginning approx 2 days s/p radiation tx.  Tx w/steroids & referred for MRI.  Developed weakness of all 4 extremities within about 2 wks.  Subsequently hospitalized as above for GBS & inpatient rehab.  Returned to Neuro 2/19/09.  Remained areflexic & profoundly weak LUE & LLE.					Y	20	Y		U	10/25/2008	10/28/2008	3	Paatient with lymphoma, had radioation on 10/3, last dose of a 26 rqadiation course.  diagnostic work up 10/28, including spinal tap.  MD admitted to hospital on 10/29 with diagnosis of Guillan Bare. Labs and Diagnostics:  EMG/NCS (+) for polyneuropathy.  CSF protein 48.  CSF glucose 84. MRI C-spineWNL. WBC initially WNL down to 2.3. RBC 3.58.  Hgb 11.7, Hct 33.1, Platelets down to 97. UC (+).  IgA <20.	UNK	UNK	Fluxoetine 20mg; dexameethsone 4mg	left arm was weak	Allergic to PCN  PMH: non-Hodgkin lymphoma left axilla 2003, tx w/chemo & radiation tx completed 2007.  Left supraclavicular mass 8/08 tx w/radiation tx completed 10/3/08.			1						1	Lumbar puncture	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA367CA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0344133	04/14/2009	FL	39.0	39		M	04/02/2009	A serious clinical trial report of allergic reaction with bronchospasm has been received from an investigator concerning a 39-year-old male, (subject number 7409052) who is enrolled in study. Medical history included smoking (currently four cigarettes per day) and a ruptured diverticulum with colostomy which was anastomosed eight weeks later in 2005. The subject did not have a history of asthma, lung disease or allergies. He was not allergic to eggs. Concomitant medications included PERCOCET as needed for lower back pain from a previous fall and TYLENOL on 22-Mar-2009 for a toothache. On 24-Mar-2009 at 1159, the subject received a dose of FLUMIST (MEDI3250). On 26-Mar-2009, at approximately 0200, the subject went to emergency room via ambulance complaining that he felt his throat tighten up and had shortness or breath which had been going on for 12 hours adn sharp chest pain which comes and goes. On physical examination, he was in moderate respiratory distress and had inspiratory and expiratory wheezes and a respiratory rate of 20. He was admitted on 26-Mar-2009 and was treated with intravenous methylprednisolone, nebulizers and IV antibiotics. A computed axial tomography scan showed no evidence of pulmonary embolism and a nonspecific right lower lobe lung nodule not visualized on the prior study. Chest X-ray posterior-anterior and lateral showed no acute parenchymal disease. Blood chemistry was remarkable for a decreased potassium level (3.2 mmol/L). Blood gas results were partial pressure of oxygen 73.8mmHg on 26-Mar-2009 and 65mmHg on 27-Mar-2009, partial pressure of carbon dioxide 40.5mmHg on 26-Mar-2009 and 38mmHg on 27-Mar-2009 and bicarbonate 23.1 mM/L on 26-Mar-2009 and 23.4 mM/L on 27-Mar-2009. The investigator indicated an allergic reaction was the etiology of the event. The subject was discharged on 28-Mar-2009. He was discharged on a prednisone taper and azithromycin. The event of allergic reaction with bronchospasm resolved on 29-Mar-2009 and the subject completely recovered on 02-Apr-2009. The investigator assessed the event of allergic reaction with bronchospasm as possibly related to FLUMIST (MEDI3250). The sponsor also assessed the event of allergic reaction with bronchospasm as possibly related to FLUMIST (MEDI3250). Analysis of Similar Events: A search of the safety database was performed on 08-Apr-2009 for case reports with he preferred terms of Hypersensitivity, Type I Hypersensitivity, Anaphylactic reaction, and Anaphylactoid reaction. The search yielded twelve case reports of hypersensitivity and four case reports of Anaphylactic reaction after the administration of FLUMIST/CAIV-T. None of the identified cases led to a fatal outcome. Four of these cases were from clinical trials; three of which were assessed as not-related to FLUMIST but rather due to other allergen (SEPTRA, food, and gourds). The fourth case that was assessed as possibly-related to study. The remaining 12 cases were from post-marketing reports, five of which were classified as serious (three spontaneous case reports of anaphylactic reaction, one spontaneous case report of hypersensitivity, and one investigator-initiated trial case report of hypersensitivity. These serious cases are briefly describe below. MEDI-0001207. This spontaneous case involves a 32-year old female who developed an anaphylactic reaction characterized by numbness of her tongue, lips and throat, as well as difficulty breathing, approximately 15-20 minutes after receiving FLUMIST. She had a BP of 106/66, pulse rate of 76, and respiratory rate of 16. Lung exam was negative for wheezing. Pulse oximetry was 98% on room air. She was treated with 0.3 ml of epinephrine (1:1000). Patient then felt chest pain and had a sensation that her throat was closing. She was transported to the emergency room where she was treated with BENADRYL and observed for 4-6 hours. She was discharged from the ER on the same day. MEDI-0006112. This is a spontaneous report of an 11-year old male with history of allergy to sulfa drugs, who received FLUMIST and a series of allergy shots (for cat, dog, birch, maple, oak, grass, ragweed, dust, mite, and mold) at the same time. Twenty minutes later, the child had an anaphylactic reaction including tightness of the throat, swollen eyes, hives, wheezing, and sneezing. He was given epinephrine and BENADRYL. The events resolved on the same day. MEDI-0006152. A spontaneous report regarding a 9-year old male who experienced an anaphylaxis reaction, described as wheezing, shortness of breath, facial edema and facial mottling, within 5 minutes of receiving FLUMIST adn VARIVAX vaccines. No additional information regarding treatment or outcome was provided at the time of the report. MEDI-0003849. This spontaneous report involved a 32-year old male who received FLUMIST from a military clinic. Three days later, he developed flea-bite like rashes on his ankles, and had burning pain sensation. He was diagnosed with scabies and was treated with Permethrin cream. The rashes progressed to other parts of his body, accompanied by edema of the forearms, legs, and hands. He was treated with oral prednisone, cetirizine, loratadine, and ranitidine, but no improvement was noted. He was subsequently transferred to a hospital, where micropustules were noted on his knuckles, arms and thigh. A skin biopsy was performed and revealed acute generalized exanthematous pustulosis. He was treated with triamcinolone body wrap, as well as oral cetirizine, loratadine, and diphenhydramine. Improvements were noted one day after the body wrap was administered. In addition to FLUMIST, the reporter also considered the possibility of drug reaction to the earlier treatments received for the rash as the cause of the reported event. This case from an investigator-initiated trial involved a 34 year-old female patient who complained of tongue numbness and swelling, as well as becoming itchy and splotchy within one hour of FLUMIST vaccination. She was treated with diphenhydramine and the events resolved. The seven non-serious cases presented with typical allergic-reaction type signs and symptoms such as rashes, urticaria, erythema, itching, swelling, numbness, and sweating. Three were reported to have resolved, while outcome was not provided in the remaining four cases. MEDI-0008275 is the only case of hypersensitivity noted in the safety database after the administration of FLUMIST (MEDI3250).					Y	2			Y	03/24/2009	03/26/2009	2	26-Mar-2009 CT angiogram of chest: no evidence of pulmonary embolism; right lower lobe lung nodule not visualized on prior study 26-Mar-2009 Electrocardiogram: normal sinus rhythm; nonspecific T wave abnormality; Base excess, 03/26/09, -2.0; 03/27/09, -1.0; Bicarbonate, 03/26/09, 23.1 mM/L; 03/27/09, 23.4 mM/L; Chest X-ray, 01/10/09, no acute disease; 03/26/09, no acute parenchymal disease; CK, 03/26/09, 278 units/L; 03/26/09, 339 units/L; 03/26/09, 377 units/L; CK-MB, 03/26/09, 1.0 NG/ML; 03/26/09, 8.8 NG/ML; 03/26/09, 0.9 NG/ML; Eosinophil count, 03/26/09, 9.2 %; Glucose, 03/26/09, 157 mg/dL; 03/27/09, 173 mg/dL; Hematocrit, 03/26/09, 36.8 %; Hemoglobin, 03/26/09, 12.9 g/dL; Oxygen saturation, 03/26/09, 94.1 %; 03/27/09, 92.7 %; PCO2, 03/26/09, 40.5 mmHg; 03/27/09, 38 mmHg; PO2, 03/26/09, 71.8 mmHg; 03/27/09, 65 mmHg; Potassium, 03/26/09, 3.2 mmol/L; 03/27/09, 4.6 mmol/L; Troponin, 03/26/09, 0.00 NG/ML; 03/26/09, 0.04 NG/ML; 03/26/09, 0.04 NG/ML	UNK	UNK	Percocet; Tylenol	Smoker; Back pain	Past Disease: Tooth ache; Ruptured diverticulum; Colostomy; Intestinal anastomosis; Fall; Diverticulitis		MEDI0008275	1						1	Angiogram; Base excess negative; Blood bicarbonate normal; Blood creatine phosphokinase MB; Blood creatine phosphokinase increased; Blood glucose increased; Blood potassium decreased; Bronchospasm; Chest X-ray normal; Chest pain; Dyspnoea; Electrocardiogram abnormal; Eosinophil percentage increased; Haematocrit decreased; Haemoglobin decreased; Hypersensitivity; Oxygen saturation decreased; PCO2 normal; PO2 decreased; Respiratory distress; Throat tightness; Troponin; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0344147	04/14/2009	TX	4.0	4		F	04/14/2009	Shingles, recurrent area on face,									Y	09/15/2006	04/10/2009	938		PVT	PVT		None	None			1						1	Condition aggravated; Herpes zoster	FLUN3~MEDIMMUNE VACCINES, INC.~500430P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~0564M~2~IM~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0343761	04/15/2009	DC	62.0	62		M	04/15/2009	This case was reported by a healthcare professional and described the occurrence of brain stroke in a 62-year-old male subject who was vaccinated with FLUARIX. Concurrent medical conditions included diabetes, and the subject was recovering from a mild cold at the time of injection. The subject had no adverse events following previous vaccinations. On 12 January 2009 at 18:00 the subject received 1st dose of FLUARIX (.5 ml unknown, left arm). No other vaccines were given on 12 January 2009. In late February 2009, a unspecified time after vaccination with FLUARIX, the subject experienced left brain stroke. The subject was in the hospital for other unspecified medical issues when the stroke occurred. The healthcare professional considered the event was disabling. At the time of reporting the event was improved. The healthcare professional considered the event was unrelated to vaccination with FLUARIX.								Y	N	01/12/2009	02/01/2009	20	UNK	PVT	PUB		Cold; Diabetes	No other vaccines were given on 12 January 2009. The subject had no adverse events following previous vaccinations.		A0778584A	1						2	Hemiparesis; Cerebrovascular accident	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA364AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA364AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Disabling	Influenza
0344175	04/15/2009	MI	18.0	18		F	04/13/2009	Information has been received from a medical assistant, for the Pregnancy Registry for GARDASIL, concerning an 18 year old female with sulfa allergy and no pertinent medical history who was vaccinated IM with the first and second 0.5 ml doses of GARDASIL by different provider and was vaccinated IM with the third 0.5ml dose of GARDASIL (lot #: 659962/1740U) on 01-DEC-2008. Concomitant therapy included loratadine. The patient who received the three doses of GARDASIL was pregnant. The patient's last menstrual period was 29-NOV-2008 and estimated delivery date was 05-SEP-2009. The patient experienced vaginal bleeding and was hospitalized at an unspecified time period. Additional information has been requested.				Y	Y				U	12/06/2008			Unknown	OTH	OTH	LORATADINE	Pregnancy NOS (LMP = 11/29/2008); Sulfonamide allergy			WAES0904USA01164	1						1	Drug exposure during pregnancy; Vaginal haemorrhage	FLU3~CSL LIMITED~AFLLA158AA~UNK~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Hospitalisation	Influenza
0344193	04/15/2009	FL	27.0	27		M	04/09/2009	Flu Shot									U	04/09/2009	04/09/2009	0		PVT	OTH						1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2750AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0344211	04/15/2009	PA	1.08	1	.2	F	04/15/2009	On 4/14/09 mother reported child had seizure 1 hr after arriving home from getting vaccines on 12/16/08. Skin was very hot. Child was taken to local ER. 3 wks later, child was reported to have had another seizure at daycare.				Y					U	12/16/2008	12/16/2008	0		PUB	PVT		None known				1						1	Convulsion; Skin warm	FLU3~SANOFI PASTEUR~UT2788AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB259AA~1~IM~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0480X~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1901U~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0344233	04/15/2009	VA	9.0	9		F	04/14/2009	Fever to 101-102. (R) arm erythema and severe pain out of proportion to exam - R/O invasive strep.  4/27/09 Received hospital medical records of 1/7-1/8/2009. FINAL DX: right arm with vaccine injection cellulitis Records reveal patient experienced pain in right upper arm since evening of vaccination.  Next day developed fever & RUE swelling & erythema with decreased right elbow ROM.  Erythema continued to enlarge w/warmth & increased pain & unable to fully extend elbow.  Tx w/oral antibiotics but condition did not improve.  PCP exam suggested possible invasive strep & pt hospitalized for IV antibiotics.  Remained stable, site improved & d/c to home on continued oral antibiotics.				Y	Y	2			Y	01/04/2008	01/04/2008	0	Bld Cx, NG; ESR, 25; Plt, 188; HgB, 13.0; HCT, 38.0; WBC, 10.2; P, 71; L, 22; M, 3; E, 4  LABS: Segs 71%(H), lymphs 22%(L).  ESR 25(H).  Blood c/s neg.  X-ray of RUE WNL.	PVT	PVT	KEFLEX 500 mg tid	No	None  PMH: allergies, s/p T&A.  Family hx: allergies.			1						1	Blood culture negative; Eosinophil count normal; Haematocrit normal; Haemoglobin normal; Heart rate normal; Injection site erythema; Injection site pain; Lymphocyte count normal; Monocyte count normal; Platelet count normal; Pyrexia; Red blood cell sedimentation rate increased; White blood cell count normal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80687~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1383U~1~IM~RA~PNEUMO (PNEUMOVAX)~1|VARCEL~MERCK & CO. INC.~1584U~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0344234	04/15/2009	VA	2.0	2	.5	M	04/14/2009	L septic hip requiring prolonged IV antibiotics and surgery.  5/4/09 Received hospital medical records of 11/11/-11/25/20007. FINAL DX: left hip septic arthritis & acute suppurative otitis media Records reveal patient experienced sudden left hip pain unable to bear weight, fever, facial flushing, decreased appetite.  Seen in outlying ER & transferred to higher level of care for peds ortho consult.  Tx w/IV antibiotics, NSAIDS & pain meds.  Taken to OR for open drainage of left hip on 11/11.  Intermittent fever while hospitalized & OM w/perforated eardrum dx on 11/25.  Improved & D/C to home on antibiotic ear drops.			Y		Y	14			Y	11/09/2007	11/09/2007	0	unknown - treated at hospital.   LABS: WBC 31.7(H), bands 22%(H), segs 57%(H), lymphs 11%(L).  ESR 47(H). CRP 18.38(H).   Metabolic panel & UA WNL.  CXR abnormal c/w bronchiolitis.  Blood, urine, hip drainage c/sMRI left hip abnormal w/joint effusion & periarticular edema	PVT	PVT	ZYRTEC	No	ZITHROMAX allergy  PMH: tracheomalacia, pneumonia, bacterial croup, seasonal allergies.  Family hx: HTN, epilepsy, DM, heart disease.			1						1	Hip surgery	FLU3~SANOFI PASTEUR~UT2447FA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0959F~1~IM~LL~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0344236	04/15/2009	WI	1.47	1	.5	M	03/19/2009	On 10.14.04 - Patient received FLU, DTAP, COMVAX, MMR & PNEUM. conj after this did not talk, quiet, sick, tired, fever (HOT) 3-4 d. ibu. given did not eat with in 2 wks, eyes rolling (thought nl after vacc). Still does not eat well. Mom thought was regressing & mad abt being held down. In bed 3d. Mom lived with guilt for 10 mo, finally presented to Dr 9-7-05. Very severe delays/regression. Does not speak (did at 11 mo). Very restricted diet, refuses most foods.   5/8/09 Received vaccine & PCP medical records. FINAL DX: Autism spectrum disorder; mixed receptive-expressive language disorder; feeding difficulties; encopresis; constipation; dental caries Records reveal patient experienced runny nose s/p cold week prior to vaccination on 10/14/04.  Developed social withdrawal & speech loss.  2/24/05 dx w/RLL pneumonia; 12/05 bilat AOM & diaper rash; 4/06 viral URI; 10/06 viral pharyngitis. Loss of language, loss of eye contact, loss of reciprocal attention/joint attention. Parent remains adamently convinced that after these 5 injections her son was ill for a week (fever/lethargy) and never recovered his previous social nature. Language is slowly coming.								Y	N	10/14/2004	10/14/2004	0		PUB	PUB	None	None - URI just done	None  PMH: fever & cold s/s; viral syndrome w/rash; recurrent bilateral AOM; large anterior fontanelle.  Birth hx: Mom on Depo when conceived; Mom smoker & social ETOH during pregnancy.  Family hx: autism.			1						1	Abnormal behaviour; Aphasia; Constipation; Decreased eye contact; Developmental delay; Diet refusal; Disturbance in attention; Eye rolling; Fatigue; Lethargy; Malaise; Pneumonia; Pyrexia; Regressive behaviour; Rhinorrhoea	DTAP~GLAXOSMITHKLINE BIOLOGICALS~434A2~4~UN~RL~DTAP (INFANRIX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~U1512AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HBHEPB~MERCK & CO. INC.~0169N~3~UN~RL~HIB + HEP B (COMVAX)~1|MMR~MERCK & CO. INC.~0415P~1~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~495305~4~UN~LL~PNEUMO (PREVNAR)~1	USA	Disabling	Influenza
0344241	04/15/2009	VA	6.0	6		M	04/14/2009	R upper arm cellulitis at injection site.				Y					Y	10/31/2008	11/01/2008	1		PVT	PUB	VYVANSE	No	ADHD;  Allergies (Environmental)			1						1	Injection site cellulitis; Injection site induration; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2797DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB319AA~2~IM~LA~HEP A (HAVRIX)~1|PPV~MERCK & CO. INC.~0622X~1~IM~RA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~0622X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0343707	04/16/2009	MO	51.0	51		F	04/09/2009	This case was received from a health professional on 02 April 2009. A 51-year-old female patient, with a history of hypertension, rheumatic fever, and allergies to sulfa and codeine, received a right deltoid intramuscular injection of FLUZONE SV 2008-2009 (lot number U2810AA) on 04 November 2008. Approximately two weeks post-vaccination, she began experiencing severe pain and burning sensations in her right upper arm. She described the pain as intermittent, with a severity of 10/10 at when symptoms were at their worst. She also stated that it has affected her range of motion in the right arm, and noted that she was unable to lay on her right side. No diagnostic or laboratory testing had been performed, and the event remained ongoing. Documents held by sender: none.				Y					N	11/04/2008	11/18/2008	14		OTH	PUB	Ibuprofen; Diltiazem; Triam + HCTZ; PCN		The patient had a history of rheumatic fever, and had hypertension. Allergies included sulfa and codeine. No illness at time of vaccination.		200901382	1						2	Burning sensation; Joint range of motion decreased; Pain in extremity; Burning sensation; Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U2810AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2810A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0344260	04/16/2009	CA	36.0	36		F	04/13/2009	This serious case was received on 01 April 2008 from a health care professional. A 37 year old female patient with a history of asthma, high blood pressure, and hypothyroidism received FLUZONE SV 2007-2008 (lot number not reported) on 15 November 2007. Date of conception was 24 August 2007. On 28 February 2008 the patient had a glucose tolerance test. Subsequently the patient was diagnosed with gestational diabetes. No further information was provided. On 08 March 2008, 18 March 2008, 01 April 2008, and 12 May 2008 the patient had visits to the ER, details were not provided. On 14 May 2008 the patient gave birth at 39.7 weeks gestation (gender not provided). The baby's birth weight was 3.130 kg. The APGAR score was a 9 at one and 5 minutes. With the exception of pyloric stenosis, there were no further congenital anomalies or complications reported. Recovery status was not reported. List of Documents held by Sender: None. The reporter of this case is the same as case number 2009-01355.				Y					U	11/15/2007	02/28/2008	105	Results were not provided for the following: 12 November 2007: glucose tolerance test, 06 December 2007 alpha-fetoprotein test, 13 December 2007, 20 February 2008, 28 April 2008 ultrasound, 15 April 2008, 18 April 2008, 22 April 2008, 29 April 2008, 02 May 2008, 06 May 2008, 09 May 2008, 13 May 2008 non stress test. 28 February 2008: glucose tolerance test: patient was diagnosed with gestational diabetes.	UNK	UNK	TYLENOL; Pre natal vitamins; Essential fatty acids	At the time of vaccination the patient was self treating with Tylenol for a headache.	Patient has a history of asthma, high blood pressure (both diagnosed in 2003), and hypothyroidism (diagnosed in 1983).		200901354	1						1	Alpha 1 foetoprotein; Drug exposure during pregnancy; Foetal disorder; Gestational diabetes; Glucose tolerance test abnormal; Ultrasound scan; Alpha 1 foetoprotein; Drug exposure during pregnancy; Foetal non-stress test; Gestational diabetes; Glucose tolerance test abnormal; Neonatal disorder; Ultrasound scan	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0344265	04/16/2009	NJ	1.6	1	.6	M	04/16/2009	LARGE RED LUMP WITH BLISTER L POSTERIOR UPPER ARM QUARTER SIZE DIAMETER. PAINFUL TO TOUCH. 3 SMALL BLISTERS AT L ELBOW. DEVELOPED 4/15/09. PT HAD STUFFY RUNNY NOSE WITH SLIGHT COUGH FOR 4 DAYS PRIOR TO DATE OF VACCINATION 4/2/09. TEMP 98.6 LUNGS CLEAR HEENT WNL..GETTING BETTER.4/7/09 PT DEVELOPED 103 FEVER WENT TO PMD DR 4/10 DX OTITIS PLACED ON AMOXICILLIN. 4/16/09 PT STILL HAS BLISTER TYPE RASH.				Y					U	04/02/2009	04/15/2009	13		UNK	UNK		STUFFY NOSE FOR 4 DAYS WITH SLIGHT COUGH				1						1	Blister; Ear infection; Injection site erythema; Injection site mass; Injection site pain; Injection site vesicles; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U2769AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB330DA~1~IM~RA~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~C71571~1~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1387X~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0344282	04/16/2009	CA	48.0	47		F	04/16/2009	LOCALIZED REACTION ON (R)UPPER DELTOID AREA PATIENT DENIES ANY DEVER, NO MALAISE; REPORTS SORE ITCHING THAN PAIN.  REDNESS MEASURES APPRX. 4.5 INCHES, CIRCUMFERENCE PATIETN REPORTS INCREASE IN REDNESS AND SWELLING (1WK)									U	04/08/2009	04/08/2009	0	NONE	PUB	UNK	NONE	NONE	NONE			1						1	Injection site erythema; Injection site pain; Injection site pruritus; Injection site swelling; Local reaction	FLU3~SANOFI PASTEUR~U2769AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2888AA~UNK~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0344300	04/16/2009	FL	28.0	28		F	04/10/2009	Received FLUZONE vaccine on 9/16/08.  November (date unknown) patient developed abdominal cramps & vaginal bleeding.  OB/GYN evaluation revealed a spontaneous miscarriage.									Y	09/16/2008	11/01/2008	46		OTH	PVT		None Clinical Research Trial	None			1						1	Abdominal pain; Abortion spontaneous; Vaginal haemorrhage	FLU3~SANOFI PASTEUR~U2532AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0344334	04/17/2009	IA				U		None Stated										04/13/2009				PUB	UNK						1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88910~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0344376	04/17/2009	IN	0.5	0	.5	M	04/17/2009	Erythematous, warm 7X7 cm. induration left lateral thigh.									Y	04/15/2009	04/16/2009	1		PVT	PUB	TMPS 5 ML B.I.D.	Serous Otitis Media				1						1	Injection site erythema; Injection site induration; Injection site warmth	FLU3~SANOFI PASTEUR~U2790AA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~021051~3~UN~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1462X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0344399	04/20/2009		64.0			M	04/20/2009	A 64-year-old male patient was admitted to the hospital after becoming unresponsive. The family reported a 2-day history of bleeding from the patient's rectum prior to admission. He had no recent changes in medical conditions or medication regimen, which included Warfarin for stroke prophylaxis secondary to atrial fibrillation. The patient had received an inactivated influenza vaccine 4.5 weeks prior to presentation, at which time his international normalized ratio (INR) was 2.0. During the 6 months prior to presentation, no medications were changed and no significant changes in the patient's health were noted. Upon admission, the patient's international normalized ratio was greater than 15; INR values over the previous 6 months had been relatively stable (range 1.4 to 4.7). A noncontrast computed tomography scan of the head showed a large parenchymal hemorrhagic infarction involving the left temporal, parietal, and occipital lobes. In the emergency department, the patient received a nitroglycerin infusion to maintain systolic blood pressure in the range of 140-160 mm Hg as well as an infusion of 4 units of fresh frozen plasma and 10 mg of vitamin K. Following a neurosurgery evaluation, it was determined that nothing meaningful could be done to alter the patient's outcome positively, and he died approximately 17 hours after admission. The patient's significant INR elevation, after being relatively stable for at least 6 months, was thought to be due to an interaction between warfarin and the influenza vaccination. The Horn Drug Interaction Probability Scale indicated a possible interaction between warfarin and the influenza vaccination. The authors also stated that the possibility of an unknown contributor to the INR elevation could not be totally excluded. Seriousness criterion: death. Causality: possible. Causality cannot be excluded as the pathomechanism remains unclear and therefore the temporal relationship cannot be assessed. Expectedness assessment according to agency label: The reported symptoms are expected after vaccination with BEGRIVAC, FLUAD, FLUVIRIN or AGRIPPAL. No change in benefit-risk-ratio. No measures necessary.  4/21/09 Per FDA COD: Intracranial hemorrhage./pc	Y								N					OTH	OTH	Warfarin	Unknown	PMH: on warfarin		MA20090925	1						1	Cerebral infarction; Computerised tomogram abnormal; Death; Haemorrhage intracranial; International normalised ratio fluctuation; Rectal haemorrhage; Unresponsive to stimuli; Alanine aminotransferase normal; Aspartate aminotransferase normal; Blood albumin decreased; Blood bilirubin normal; Blood product transfusion; Brain herniation; Brain mass; Computerised tomogram abnormal; Death; Haematocrit decreased; Haemoglobin decreased; Haemorrhagic infarction; International normalised ratio increased; Platelet count normal; Rectal haemorrhage; Unresponsive to stimuli; Alanine aminotransferase normal; Aspartate aminotransferase normal; Blood albumin decreased; Blood bilirubin normal; Blood product transfusion; Computerised tomogram abnormal; Computerised tomogram head; Death; Haematocrit decreased; Haemoglobin decreased; Haemorrhagic cerebral infarction; Heart rate normal; International normalised ratio increased; Platelet count normal; Rectal haemorrhage; Respiratory rate; Unresponsive to stimuli; Alanine aminotransferase normal; Aspartate aminotransferase normal; Blood albumin decreased; Blood bilirubin normal; Blood product transfusion; Cerebral infarction; Computerised tomogram abnormal; Death; Haematocrit decreased; Haemoglobin decreased; Haemorrhagic infarction; International normalised ratio increased; Platelet count normal; Rectal haemorrhage; Unresponsive to stimuli	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|FLU3~CSL LIMITED~~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~4	USA	Results in Death	Influenza
0344435	04/20/2009	OH	1.0	1	.0	F	04/20/2009	vaccines admin 01/08/09, pt started with fever 01/09/09 3:00am - Mom states pt was burning up and guessed fever at 100 (did not measure it). Gave Tylenol. Then spiked fever at 5:00am, had a seizure and squad was called. Taken to Emergency room, and admitted for 3 days. Had a total of 3 seizures, but none after fever controlled with alternating Tylenol / Motrin at the hospital. Mom unsure if she was giving the appropriate dose of Tylenol at home. Mom stated tests all came back fine but the doctor at the hospital said pt should have never gotten 8 shots.  4/21/09 MR received for DOS 1/9-11/2009 with D/C Dx: Acute Febrile seizure. Acute febrile illness. Bacteruria.  Metabolic acidosis 2' to seizure or dehydration. Pt presented on the morning after vaccines with fever and several episodes of seizure.  Pt initially seen by parent shaking with eyes rolled back.  EMS called and pt had another episode in ambulance and one in ER.  Tx with IV abx for ? UTI with improvement.  No further seizures. D/C on po abx.				Y	Y	3			Y	01/08/2009	01/09/2009	1	Labs:  UC (+) for mixed growth. UA (+) for blood, RBCs, 2-4 WBCs, many bacteria, trace ketones and 30 protein. Blood cx (-). CXR (+) for viral bronchiolitis. CRP 1.4	UNK	UNK	unknown	none reported	none reported PMH:  RAD			1						1	Convulsion; Feeling hot; Pyrexia	DTAP~SANOFI PASTEUR~U2471AA~3~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT2787CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB247AA~1~IM~RL~HEP A (HAVRIX)~1|HIBV~SANOFI PASTEUR~UF441AA~3~IM~LL~HIB (ACTHIB)~1|IPV~SANOFI PASTEUR~A1060~3~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0908X~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C71571~3~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0992X~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0344447	04/20/2009	FL	14.0	14		F	04/20/2009	fever, vomiting,malise, headache could not get out of bed for 2 weeks after 1st shot.  Developed periphreal neurapathy within 30 days of 1st shot.  However it took 3 months to diagnose. Gastritis several times. Migraines constantly, fainting with muscle weakness...can not use legs for hours after faintinf, bloody stools, paralysis in right arm immediately after third vaccine.  Pallor, clamminess, amennorhea no period since first vaccine.  fatigue, insomnia, sleep apnea, chest pain, pins and needle sensations throughout extremities, sinusitis several times, pins and needles feelings in stomach, fevers on and off, slurred speech.  She has been very ill since first vaccine and in a lot of pain.  5/1/09 Received vaccine & PCP medical records of 11/14/06-1/9/2009. FINAL DX: none provided Records reveal patient experienced shooting paine & numbness of extremities 2 wks prior to HPV #1 & flu shot. RTC w/recurrent depression, left plantar fasciitis, migraine HAs.  Seen in ER 3/13/08 for HA & dx w/ethmoid sinusitis, tonsillitis & URI.  RTC w/viral gastroenteritis, right CTS, recurrent allergic rhinitis.  8/18/08 w/spells x 3-4 yrs which had increased in frequency x 3 wks; dx w/presyncopal episodes.  Seen in ER w/dx gastroenteritis.  Referred to Neuro for syncope.  Missed several days of school.  RTC for LBP s/p fall, gastritis w/bloody stools.  6/15/09 Received consultant medical records of 1/29/08-5/26/2009. Pulmonology records reveal patient experienced sleep disturbance, obstructive sleep apnea, increasing obesity, nasal congestion, and allergic rhinitis. Residual cough. Low bloodpressure. ENT - intranasal mucosal edema and clear drainage, deviated septum, mouth and oral cavity small, enlarged tonsils, redundant pharyngeal mucosa, obese neck. Tonsillectomy / Adenoidectomy. Neurology -  patient c/o burning in feet, dizzeness, fainting spells, clamminess, sweating, shooting pains in wrists /ankles, difficulty focusing / concentrating. Examination is unremarkable. Ophthalmologic evaluation reports some loss of peripheral vision.				Y				Y	N	11/14/2007	11/14/2007	0	EKG, Holter Monitor, EEG, Sleep Studies, Heavy Metal test, CBC, Urinalysis, Upper GI, Stool sample, Hepatitis test, CBC, metobolic study, Cat Scans, MRI, Has seen neurologist, pulmonary doctor, podiatrist, endocrinologist, tons on blood work.  Has had blood in urine.  LABS: CBC, ESR, ANA, TSH, echocardiogram, Holter monitor, EEG WNL.  AST/ALT 47/62(H).  EKG W/sinus tachycardia.   6/15/09 Received consultant medical records of 1/29/08-5/26/2009. LABS and Diagnostics: EEG - WNL. CT Head - Normal. Slightly abnormal' Holter.	UNK	UNK	lo-ogesterl, vitamins, metanx, glucophase, prozac, trazadone, spironlactone	hypoglycemia, PCOS, depression	mold, cockroaches, smoke, dust, dust mites, trees, grass,perfume allergies PCOS, blounts, hypoglycemia,  PMH: exudative pharyngitis, metabolic syndrome w/hirsutism, Type II DM w/peripheral neuropathy, metromenorrhagia, morbid obesity, Blount's disease w/left tibial lengthenins & reshaping via cage, left gastrocnemius contracture, bronchitis, URI, sleep apnea, restless leg syndrome, insomnia, congenital liver disease, hives, allergic rhinitis, bipolar w/recurrent depression, panic attacks.  Allergy: trees, dust, pollen, mold.  OCPs. Family hx: sibling bipolar, migraines.  HPV #2, lot # 03894, given 1/18/08, LA; HPV#3, lot #1970U, given 5/14/08, RA.  6/15/09 Received consultant medical records of 1/29/08-5/26/2009. Obesity, Type II diabetes.			1						1	Activities of daily living impaired; Amenorrhoea; Blood heavy metal test; Blood urine present; Chest pain; Cold sweat; Dysarthria; Fatigue; Gastritis; Haematochezia; Headache; Hepatitis viral test; Immediate post-injection reaction; Insomnia; Malaise; Metabolic function test; Mobility decreased; Monoplegia; Muscular weakness; Neuropathy peripheral; Nuclear magnetic resonance imaging; Pallor; Paraesthesia; Pyrexia; Similar reaction on previous exposure to drug; Sinusitis; Sleep apnoea syndrome; Sleep study; Stool analysis; Syncope; Urine analysis; Vomiting; X-ray with contrast upper gastrointestinal tract	FLUX~UNKNOWN MANUFACTURER~u24767ga~3~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~0389U~1~IM~LA~HPV (GARDASIL)~1	USA	Disabling	Influenza
0344448	04/20/2009	UT	26.0	26		M	04/15/2009	Fever (102 degrees F) lasting 36 hours. Chills on 4-11-09 pain in both deltoid muscles radiating into neck area. Dr visit on 4-12-09 given RX for ibuprofen. Pain in arms and neck slowly decreasing.				Y					N	04/09/2009	04/09/2009	0	none	PUB	PVT	AVAPRO; ATENOLOL	none	Defective heart valve, surgically corrected			1						1	Chills; Neck pain; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U2772AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C3070AA~1~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0344456	04/20/2009	CA	1.8	1	.8	M	04/02/2009	Family took patient to walk-in vaccine clinic. Obtained #2 Hepatitis A dose, #4 Pneumococcal dose (each in left thigh), and Influenza Split virus dose (right thigh). Patient was laughing, eating, playful, when sunshine into house illuminated fine bumps on right side of chest at 4:30 PM. Mother took rectal temp of 99.9 degrees F. At 6:30 PM she gave BENADRYL (5ml of 12.5 mg); at 8:30 PM Ibuprofen 100 mg.				Y					Y	04/01/2009	04/01/2009	0	None	MIL	MIL	None	None	None			1						1	Body temperature increased; Rash	FLU3~SANOFI PASTEUR~UT2792CA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB329CA~2~IM~LL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~D46873~4~IM~LL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0344469	04/20/2009	TX	28.0			M	04/13/2009	None stated.														UNK	UNK						1						1	No adverse event	FLU3~SANOFI PASTEUR~U2749AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0344477	04/20/2009	IL	0.7	0	.7	F	04/17/2009	03/21/2009 started with cold & cough, gave TYLENOL for fever.  On 3/26/09 Baby was very irritable R side of body- hand & leg would jerk simultaneously every 1/2 hour.  Irritability & crying increased went to ER 3 27 09 gave given IV fluids and hosp. was told due to shots				Y					Y	03/18/2009	03/21/2009	3		PUB	UNK	None	None	None			1						1	Cough; Crying; Dyskinesia; Irritability; Nasopharyngitis; Pyrexia	FLU3~SANOFI PASTEUR~U2831AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0344498	04/20/2009	CA	15.0	15		F	04/15/2009	Per mother of Pt; Pt arms became tender + painful (@ injection site) approx 6-7 hrs after injections, the hands became swollen itching next day Pt reported to mother. A rash between her fingers - mother noticed swelling on her wrists Pt mother reported s/s resolved @ the time.									Y	04/09/2009	04/09/2009	0		PUB	PUB	None	None reported	None		CA090002	1						1	Injection site pain; Joint swelling; Oedema peripheral; Pruritus; Rash	FLU3~SANOFI PASTEUR~U2855AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB281BB~3~UN~RA~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~M060~5~UN~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~15824~3~UN~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|MNQ~SANOFI PASTEUR~U2569AA~2~UN~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~1748X~3~UN~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0344897	04/20/2009	MD	4.0	4		F	03/12/2009	A non-serious, spontaneous report of administered expired product was received from a nurse concerning a four-year-old female, subsequent to FLUMIST. The patient received FLUMIST on 20-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up received 31-Mar-2009: added product complaint investigation results.									Y	02/20/2009	02/20/2009	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0008077	1						1	Expired drug administered; Product quality issue	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0344898	04/20/2009	MD	1.3	1	.3	F	03/12/2009	A non-serious, spontaneous report of administered expired product was received from a nurse concerning a 15-month-old female subsequent to FLUMIST. The patient received FLUMIST on 23-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up received 31-Mar-2009: added product complaint investigation results.									Y	02/23/2009	02/23/2009	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0008075	1						1	Expired drug administered; Product quality issue	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0344899	04/20/2009	MD	3.0	3		F	03/12/2009	A non-serious, spontaneous report of administered expired product was received from a nurse concerning a four-year-old female, subsequent to FLUMIST. The patient received FLUMIST on 17-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 31-Mar-2009 and incorporated into the narrative: added product complaint investigation results.									Y	02/17/2009	02/17/2009	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0008073	1						1	Expired drug administered; Product quality issue	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0344900	04/20/2009	MD	3.0	3		F	03/31/2009	A non-serious, spontaneous report of administered expired product was received from a nurse concerning a four-year-old female, subsequent to FLUMIST. The patient received FLUMIST on 17-Feb-2009, which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 31-Mar-2009 and incorporated into the narrative: added product complaint investigation results. Reporter does not have lut number. Information cannot be obtained. 29 JUL 2009.									Y	02/17/2009	02/17/2009	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0008072	1						1	Expired drug administered; Medication error; Product quality issue	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0344901	04/20/2009	TX	3.9			M	03/02/2009	A non-serious spontaneous report of expired FLUMIST given was received from a company sales representative concerning a 47-month-old male. On 23-Feb-2009, a Medical Assistant on a Student Health campus inadvertently administered expired FLUMIST to a child. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. This is in follow-up to report(s) previously submitted on 03/02/2009. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up received on 06-Apr-2009 includes: this was patient's first dose of FLUMIST; country where the office is located and no adverse events were reported. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	02/23/2009	02/23/2009	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0008036	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500541P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0345780	04/20/2009					M	04/20/2009	Information has been received from a registered nurse concerning a male who last week was vaccinated with VARIVAX (Merck). Concomitant therapy included FLUZONE. The patient experienced difficulty breathing, hives, cough and facial edema. Additional information has been requested.									U					OTH	OTH			Unknown		WAES0904USA02081	1						1	Cough; Dyspnoea; Face oedema; Urticaria	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~~UNK~UN~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0344539	04/21/2009	NY	6.0			M	04/21/2009	Child received PPD and Flu vaccine 4-15-09.Next day he developed fever.Red rashes developed on forehead.Mom gave a dose of benadryl elixir 1 tsp and rash seem to come down a little.That same morning he bumped his head on the bed railing and sustained a little hematoma on forehead.									Y				none	PUB	PUB		no	no			1						1	Erythema; Haematoma; Head injury; Pyrexia; Rash	FLU3~SANOFI PASTEUR~u2765aa~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0340175	04/22/2009	NY	39.0	39		F	02/20/2009	Dizziness, hives, tight chest and difficulty breathing that lasted 3 hours.									Y	09/20/2008	09/20/2008	0	none	PUB	PUB	LYRICA; ULTRACET; omnoeris sastline	none	none			1						2	Chest discomfort; Dizziness; Dyspnoea; Urticaria; Chest discomfort; Dizziness; Dyspnoea; Urticaria	FLUX~UNKNOWN MANUFACTURER~~3~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~2765AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0344637	04/22/2009	IN	22.0			F	04/21/2009	Non stated.														PVT	UNK						1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA176AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0344674	04/23/2009	CA	4.0	4		F	04/23/2009	After administration of a subcutaneous MMR vaccination using a VanishPoint syringe, a black dot appeared on the site of injection.									U	12/18/2008	12/18/2008	0	None.	PVT	UNK	Unknown.	Unknown.	Unknown.			1						1	Injection site discolouration	FLU3~SANOFI PASTEUR~U2803AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1507X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0344690	04/23/2009	ID	45.0	45		F	04/23/2009	This case was reported by a consumer and described the occurrence of throat tingling in a 45-year-old female subject who was vaccinated with influenza virus vaccine (Flu vaccine, GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included METFORMIN, CENESTIN, LEVOTHYROXINE, Aspirin, LEVODOPA/CARBIDOPA and Hormone replacement therapy. On 17 October 2008 at 11:30 the subject received unspecified dose of Flu vaccine in the right arm. On 17 October 2008, while still in the doctor's office following vaccination with Flu vaccine, the subject experienced tingling in the back of the throat within 10 minutes, chest tightness within 15 minutes, chest pain within 15 minutes and thirst. An EKG and blood work were done. The EKG was ok. The subject was referred to a cardiologist on 18 December 2008. The subject received a nuclear heart scan and another EKG. The subject had a follow-up visit on 12 January 2009. No specifics were reported. On 06 February 2009, the subject went back to the doctor and was prescribed ALEVE and 2 baby aspirin. The chest pain improved some following treatment with ALEVE and baby aspirin. Throat tingling reportedly resolved, chest tightness remained unresolved and the outcome of thirst was not known at the time of reporting. The reporter commented that she was not sure if she received FLULAVAL or FLUARIX, but she was told that the flu vaccine given to her was one of GlaxoSmithKline's. Follow-up information was received on 24 March 2009 from physician's office. On 17 October 2008, the subject had blood testing done and received a flu shot. After her blood testing was done, the subject felt lightheaded. Her throat tickled. Blood pressure was 101/66 and pulse was 56. Her blood pressures were repeated at 102/72 lying down, 112/64 sitting and 105/72 with pulses of 52, 64, and 49 respectively. The subject's blood glucose was 77. She was given a cola drink to drink and laid down. She slowly began feeling better. The subject also complained of increased dizziness. She remained talkative and her speech was fluent and she followed well. She was given an electrocardiogram (EKG) due to mild symptoms of chest pain which was normal. After laying down, the subject did slowly feel better. She was discharged from the clinic with precautions. She was going to stay in town one more night to make sure she felt better. Follow-up information was received from the subject on 13 April 2009. On 15 March 2009, while trying to do some work in the living room, she had to sit down and could not do anything most of the day. Then on 23 March 2009, her previous reported symptoms worsened, and she went to her local emergency department. She was then airlifted the same day to a hospital. A pulse could not be obtained in her leg and she barely had a blood pressure. While at the hospital, she had a heart catheterization, computed tomography (CT) scan, and ultrasounds performed. Everything was normal, and she was discharged on 25 March 2009. That night while at home, she experienced a sharp burning feeling in her right leg and a jabbing feeling in her chest. The next day, 26 March 2009, she went to her local emergency department and was hospitalized. She was discharged the following afternoon on 27 March 2009. A magnetic resonance imaging (MRI) was conducted, and she was then referred to a neurologist. Also, during this timeframe three weeks ago from the time of reporting, she started to experience trouble walking and states the pain started in her ankles, then went to her calf and is now up at her shoulders. She saw the neurologist who referred her back to her primary care physician. On her way to the primary care physician, the pain started going up her legs and fingers, and her friend, who is a nurse, advised her to stop at a hospital. A lumbar puncture and ultrasound were conducted, and she also saw a neurologist there. She was then referred back to her original local neurologist. On 10 April 2009, she went back to the original neurologist, and this neurologist now wants her to see a rheumatologist. The subject stated that the physicians are telling her something is wrong, but they do not know what is wrong. She states her physicians do not think it is heart related because her tests have come back negative, however, they do believe it may be neurological. She stated there has been talk of Guillain-Barre Syndrome, but they do not think it is that because it occurs more quickly. The subject stated that she still does not know which GSK flu vaccine she received.				Y	Y	0			U	09/17/2008	09/17/2008	0	Blood glucose, 17Oct2008, 77; Electrocardiogram, 17Oct2008, normal; On unspecified dates the subject had an EKG and blood work performed. It was reported that the EKG was Ok, but the results of the blood work weren't stated. The subject later received a nuclear heart scan and another EKG on unspecified dates. The results were not reported. March 2009: Sometime from 23 March 2009 to 25 March 2009, the subject had a heart catheterization, computed tomography (CT) scan and ultrasounds performed which were reported by the subject to be normal. Magnetic resonance imaging (MRI) was performed on an unspecified date. Results not specified). Lumbar puncture and ultrasound were conducted on unspecified dates. Results were not specified.	PVT	MIL	Metformin hydrochloride; Cenestin; Thyroxine sodium; Aspirin; Co-careldopa; HRT	Unknown	Gestational Diabetes; Restless Legs Syndrome; Shingles; The subject has previously received flu shots with no reaction. There is no history of adverse events following previous vaccinations. March 2009: Heart catheterization, computed tomography (CT) scan and ultrasound were normal.		A0768930A	1						1	Activities of daily living impaired; Arthralgia; Blood glucose normal; Blood pressure decreased; Blood test; Burning sensation; Catheterisation cardiac; Chest discomfort; Chest pain; Computerised tomogram normal; Dizziness; Electrocardiogram normal; Gait disturbance; Heart rate decreased; Lumbar puncture; Musculoskeletal pain; Nuclear magnetic resonance imaging; Pain in extremity; Pulse absent; Thirst; Throat irritation; Ultrasound scan normal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0344707	04/23/2009	WA	31.0	31		M	04/23/2009	Raised irregular shaped welts - No temp. - Itchy on parts of arm/legs and torso - Recommended BENADRYL _ See Dr. if not better.									U	04/21/2009	04/22/2009	1	None	OTH	PVT						1						1	Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA366CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0338849	04/24/2009		0.57	0	.6	F	04/10/2009	Information regarding PREVNAR was received from a healthcare professional regarding a 6-month-old female patient who experienced diarrhea, vomiting, fever of 101.6 degrees F. and voiding once every 24 hours. At 6 months of age, the patient received the third dose on 06-Jan-2009. The patient also received the second dose of HIBEST (Pasteur Vaccins) and the third dose of PEDIARIX (Glaxosmithkline) on 06-Jan-2009. Additional suspect medication included ROTARIX. The patient experienced diarrhea, vomiting and fever of 101.6 degrees F. and voiding once every 24 hours on 06-Jan-2009. Outcome was reported as not recovered. No additional information was available at the time of this report.									N	01/06/2009	01/06/2009	0	None Provided.	UNK	UNK	Concomitant medications were not reported.		Relevant medical history was not provided.		USWYEH07830109	1						3	Diarrhoea; Oliguria; Pyrexia; Vomiting; Diarrhoea; No reaction on previous exposure to drug; Pyrexia; Urine output decreased; Vomiting; Diarrhoea; Pyrexia; Urine output decreased; Vomiting	RV5~MERCK & CO. INC.~0310X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B137AA~UNK~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~2|FLU3~SANOFI PASTEUR~UT2786G~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|HIBV~SANOFI PASTEUR~A0900~UNK~ID~LL~HIB (ACTHIB)~2|PNC~PFIZER\WYETH~C73459~UNK~IM~LL~PNEUMO (PREVNAR)~2|DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC121B137AS~3~UN~UN~DTAP + HEPB + IPV (PEDIARIX)~3|HIBV~SANOFI PASTEUR~UI4428A~2~UN~UN~HIB (ACTHIB)~3|PNC~PFIZER\WYETH~C73459~3~IM~UN~PNEUMO (PREVNAR)~3|RV1~GLAXOSMITHKLINE BIOLOGICALS~0310X~UNK~PO~MO~ROTAVIRUS (ROTARIX)~3	USA		Influenza
0344841	04/24/2009	NY	25.0	24		M	04/20/2009	None stated.									Y	04/20/2009				PVT	OTH						1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89979~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0345025	04/24/2009		0.3	0	.3	M	04/10/2009	Information regarding PREVNAR was received from a healthcare professional regarding a 4-month-old male patient who experienced injection site abscess. The patient received a second dose on 24-Sep-2007.  The patient also received a dose of Haemophilus Influenzae B (manufacturer unknown) and a dose of BOOSTRIX (GlaxoSmithKline) on 24-Sep-2007. The patient received a second dose of PREVNAR on 24-Sep-2007. On 05-Nov-2007, while at the doctors for a cold, the patient was diagnosed with an injection site abscess in his right thigh. Treatment was not reported. The patient recovered, but left permanent 5cm at site. See related case (s): US-WYE-H03233908 (adverse event, non-expedited). No additional information was available at the time of this report									Y	09/24/2007	11/05/2007	42	Culture wound, negative, it was done on an unspecified date	UNK	UNK		Nasopharyngitis.			USWYEH03187808	1						1	Culture wound negative; Injection site abscess	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PNC~PFIZER\WYETH~B539818~2~~~PNEUMO (PREVNAR)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~TDAP (BOOSTRIX)~1	USA		Influenza
0326209	04/27/2009		21.0			F	03/27/2009	This case was received on 11 January 2009 via a QScan search on the VAERS database, under reference number 326209.  A 21-year-old female patient received the following vaccinations on 02-Sep-2008:  SMALLPOX vaccine (manufacturer unknown, lot number not reported).  NOTE:  Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed SMALLPOX vaccine at the time of the patient's vaccination; and FLU MIST (manufactured by Med immune, lot number not reported).  The patient also received a third Anthrax vaccinaton on 03-Sep-2008 (manufacture and lot unknown).     The patient reported having left arm pain and noted a swollen lymph node on the left side of her neck and left axilla with accompanying pain in these areas.  On 06 September 2008, the patient started having intermittent left arm and hand numbness.  On the night of 06 September 2008 she experienced chest pressure (graded six out of ten on a pain scale) which increased while lying down and improved upon sitting up.  The patient denied shortness of breath but did report feeling anxious and felt her heart pounding.  The chest pain lasted 48 hours.  On 11 September, the patient was seen in the Emergency Room and was told that she was released to full duty.  Laboratory results reported on 11 September 2008 included the following:  Troponin I Cardiac PLASMA : 0.012 ng/mL; creatine Kinase MB PLASMA: 0.3 ng/mL; BNP Blood: 10.8 pg/mL; INR PLASMA: 0.99; Pro time PLASMA: 11.55 sec and APTT PLASMA: 28.70 sec.  There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported.  Latency has been calculated using the event date.  List of documents held by sender: none										09/02/2008	09/06/2008	4	11-Sep-2008 Troponin I Cardiac PLASMA : 0.012 ng/mL; creatine Kinase MB PLASMA: 0.3 ng/mL; 11-Sep-2008 BNP Blood: 10.8 pg/mL; 11-Sep-2008 INR PLASMA: 0.99; Protime PLASMA: 11.55 sec; 11-Sep-2008 APTT PLASMA: 28.70 sec; Creatine Kinase SE	UNK	UNK			Medical history not reported		200900545	1						2	Activated partial thromboplastin time; Blood creatine phosphokinase; Blood creatine phosphokinase MB normal; Chest discomfort; Hypoaesthesia; International normalised ratio decreased; Lymphadenopathy; Pain in extremity; Palpitations; Troponin I	ANTH~UNKNOWN MANUFACTURER~~UNK~UN~UN~ANTHRAX (NO BRAND NAME)~2|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~2|SMALL~EMERGENT BIOSOLUTIONS~~UNK~ID~LA~SMALLPOX (ACAM2000)~2	USA		Influenza
0326315	04/27/2009		20.0			M	03/16/2009	This case was received on 11 January 2009 via a search on the VAERS database, under reference number 326315. A 20-year-old patient, whose medical history was not reported, received the following vaccinations on 16 September 2008: smallpox (trade name and manufacturer unknown, lot number not reported) and FLUMIST (Medimmune Vaccines, lot number not reported). On 23 September 2008, the patient developed flu-like symptoms with nasal congestion, cough, headache, and myalgias. On 25 September 2009, 9 days post vaccination, the patient developed a diffuse pruritic, erythematous, papular rash involving the face, trunk, extremities, palms and soles. A CBC was performed and was normal except for mild monocytosis of 11.7%. On 25 September, 2008, the patient received treatment with PREDNISONE, LORATADINE, HYDROXYZINE, and RANITIDINE. The patient's recovery status was not reported. Note: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.									U	09/16/2008	09/23/2008	7		UNK	UNK			Medical history, concomitant medications, and illness at time of vaccination were not reported.		200900546	1						2	Cough; Headache; Influenza like illness; Monocytosis; Myalgia; Nasal congestion; Rash erythematous; Rash papular; Rash pruritic	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|SMALL~EMERGENT BIOSOLUTIONS~~UNK~ID~UN~SMALLPOX (ACAM2000)~2	USA		Influenza
0326719	04/27/2009		37.0			F	03/04/2009	This case was received on 11 January 2009 via a QScan search on the VAERS database, under reference number 326719.  A 37 year-old female patient received the following vaccination on 12 September 2008:  SMALLPOX (manufacturer unknown, lot number not reported), and influenza (FLUMIST, Medimmune, lot number not reported).  The patient experienced inadvertent inoculation to multiple sites.  Eight days after vaccination, on 20 September 2008, the patient reported fever (maximum 104 degrees Fahrenheit), headache, left arm swelling, and axillary, cervical, clavicular lymphadenopathy.  The patient reported three satellite lesions around the vaccination site as well as lesions over right thumb pad.  On 23 September 2008, lesions were noticed between right 4th and 5th toe and on 24 September 2008, on the upper lip.  The patient was seen in the Emergency Room on 22 September 2008.  No treatment was reported.  Laboratory tests performed were reported as follows:  CBC with diff unremarkable; CMP with slight elevation of AST (46) and ALT (69); and skin wound culture of the SMALLPOX vaccination site showed mixed normal skin flora.  On 26 September 2008, bilateral wrist and finger swelling and pain, and single erythematous macule over the left 1st and right 5th MCP joints were reported.  As of 1 October 2008, symptoms were reported as resolved.  NOTE:  Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed SMALLPOX vaccine at the time of the patient's vaccination.  List of Documents held by Sender:  None				Y						09/12/2008	09/20/2008	8	Laboratory tests performed were reported as follows:  CBC with diff unremarkable; CMP with slight elevation of AST (46) and ALT (69); and skin wound culture of the SMALLPOX vaccination site showed mixed normal skin flora.	UNK	UNK					200900597	1						2	Accidental exposure; Alanine aminotransferase increased; Aspartate aminotransferase increased; Culture wound negative; Erythema; Full blood count normal; Headache; Injection site reaction; Joint swelling; Lymphadenopathy; Metabolic function test; Oedema peripheral; Pain; Pyrexia; Rash macular; Skin lesion	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~2|SMALL~EMERGENT BIOSOLUTIONS~~UNK~ID~UN~SMALLPOX (ACAM2000)~2	USA	Emergency room visit	Influenza
0327024	04/27/2009		26.0			F	03/16/2009	This case was received on 17 December 2008 via a Qscan search on the VAERS database, under reference number 327024. A 26-year-old female patient, whose medical history was not reported, received the following vaccinations on 16 September 2008: a first dose of ACAM2000 (lot number not reported), a subcutaneous injection of BIOTHRAX (Emergent Biosolutions, lot number not reported) and an intranasal dose of FLUMIST (manufacturer unknown, lot number not reported). The patient was reported to have developed generalized vaccinia eleven days after vaccination. On 29 September 2008, 13 days post-vaccination, she was seen in urgent care and referred to a dermatology clinic. Corrective treatment was not reported, but the patient was put on convalescent leave for one week. The patient's recovery status was not reported. NOTE: There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date.									U	09/16/2008	09/29/2008	13		UNK	UNK		Illness at time of vaccination were not reported.	Medical history, concomitant medications were not reported.		200900590	1						2	Activities of daily living impaired; Vaccinia	ANTH~EMERGENT BIOSOLUTIONS~~UNK~SC~UN~ANTHRAX (BIOTHRAX)~2|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|SMALL~EMERGENT BIOSOLUTIONS~~1~ID~UN~SMALLPOX (ACAM2000)~2	USA		Influenza
0328459	04/27/2009		38.0			M	03/16/2009	This case was received on 17 December 2008 via a QScan search on the VAERS database, under reference number 328459.  A 38-year-old male patient, whose medical history was not reported, received the following vaccinations on 25 September 2008:  ACAM2000 (lot number not reported) and FLUMIST (MedImmune Vaccines, lot number not reported).  On 04 October 2008, nine days post-vaccination, the patient had a 10 cm area of redness around area of the head, arms, back, chest, and legs with eruption of acneiform pustules.  Corrective treatment and the patient's outcome were not reported.									U	09/25/2008	10/04/2008	9		UNK	UNK		Illness at time of vaccination were not reported.	Medical history, concomitant medications were not reported.		200900592	1						2	Dermatitis acneiform; Rash erythematous; Rash pustular	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|SMALL~EMERGENT BIOSOLUTIONS~~UNK~ID~UN~SMALLPOX (ACAM2000)~2	USA		Influenza
0328597	04/27/2009		29.0			M	03/16/2009	This case was received on 17 December 2008 via a QScan search on the VAERS database, under reference number 328597. A 29 year-old male patient received the following vaccinations on 02 October 2008: SMALLPOX (manufacturer unknown, lot number not reported), and FLUMIST (Medimmune, lot number not reported). Note: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed SMALLPOX vaccine at the time of the patient's vaccination. One to two days after vaccination, the patient developed hives on his arms, chest, stomach and armpits and throat swelling. The patient was diagnosed with an allergy to latex. He was treated with BENADRYL and antibiotics and issued allergies tags which included latex. The patient recovered. List of Documents held by Sender: None.									Y	10/02/2008	10/03/2008	1		UNK	UNK					200900593	1						2	Latex allergy; Pharyngeal oedema; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~2|SMALL~EMERGENT BIOSOLUTIONS~~UNK~ID~UN~SMALLPOX (ACAM2000)~2	USA		Influenza
0333440	04/27/2009		36.0			M	03/16/2009	This case was received on 02 February 2009 via a search of the VAERS database (reference number 333440).  It was originally reported to VAERS by another manufacturer (manufacturer unknown).  A 36 year-old patient received the following vaccinations on 31 October 2008:  SMALLPOX (ACAM2000, lot number not reported), TYPHIM VI, lot number not reported), BIOTHRAX, manufacturer Bioport Corporation, lot number not reported), TWINRIX, manufacturer GSK, lot number not reported), and FLUMIST, manufacturer MedImmune, lot number not reported).  On 11 November 2008 the patient complained of chest pain with radiation to the left arm associated with diaphoresis and elevated blood pressure, light headache and difficulty taking a deep breath.  The chest pain was worse in the morning on 13 November 2008.  The pain was worse when lying flat, with cough, or deep breath but not associated with exertion and was non-prandial.  The patient was treated with MOTRIN at a local clinic during his visit on 14 November 2008.  On 14 November 2008 the patient had positive cardiac enzymes.  The patient was referred to the hospital on 18 November 2008 and was admitted.  The patient's chest pain lasted about one week, was constant for three days, then became intermittent.  Lab work included:  a negative cardiac work up with the exception of an elevated troponin 0.97, normal ECG, EF 55%, blood triglycerides normal, high density lipoprotein normal, blood cholesterol normal, blood creatine phosphokinase MB normal, chest x ray normal, complete blood count normal, normal echocardiogram and normal stress test.  Since this episode he had cold like symptoms including runny nose and a cough but he was without chest pain.  He performed activities of daily living without chest pain, tightness or shortness of breath.  The patient's final diagnosis was non-cardiac chest pain, asthma, and tobacco use disorder.  The patient was discharged on 19 November 2008.  The patient recovered from the events.  List of Documents held by Sender:  None.					Y	1			Y	10/31/2008	11/11/2008	11	Lab work included: a negative cardiac work up with the exception of an elevated troponin 0.97, normal ECG, EF 55%, blood triglycerides normal, high density lipoprotein normal, blood cholesterol normal, blood creatine phosphokinase MB normal, chest x ray normal, complete blood count normal, normal echocardiogram and normal stress test.	UNK	UNK			Not reported		200900363	1						2	Asthma; Blood cholesterol normal; Blood creatine phosphokinase MB normal; Blood pressure increased; Blood triglycerides normal; Cardiac function test normal; Cardiac stress test normal; Chest X-ray normal; Chest pain; Cough; Dyspnoea; Echocardiogram normal; Ejection fraction decreased; Electrocardiogram normal; Full blood count normal; Headache; High density lipoprotein normal; Hyperhidrosis; Nasopharyngitis; Non-cardiac chest pain; Rhinorrhoea; Tobacco abuse; Troponin increased	ANTH~EMERGENT BIOSOLUTIONS~~UNK~SC~UN~ANTHRAX (BIOTHRAX)~2|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~HEP A + HEP B (TWINRIX)~2|SMALL~EMERGENT BIOSOLUTIONS~~UNK~ID~UN~SMALLPOX (ACAM2000)~2|TYP~SANOFI PASTEUR~~UNK~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~2	USA	Hospitalisation	Influenza
0334265	04/27/2009		22.0			U	03/05/2009	This case was received on 23 February 2009 via a QScan search on the VAERS database, under reference number 334265.  A 22-year-old patient (gender unknown), whose medical history was not reported, received the following vaccinations on 28 October 2008: SMALLPOX (trade name and manufacturer unknown, lot number VV04003A), ANTHRAX (trade name and manufacturer unknown, lot number FAV149) and FLUMIST (Medimmune Vaccines, lot number 500556P).  On 29 October 2008, one day post-vaccination, the patient developed nausea, vomiting, a headache, and myalgias.  The patient went to the emergency room and was seen in the medical treatment facility for 2 days.  The patient was given symptomatic treatment and the symptoms resolved.  NOTE:  Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed SMALLPOX vaccine at the time of the patient's vaccination.					Y	0			Y	10/28/2008	10/29/2008	1		OTH	OTH		Illness at time of vaccination were not reported.	Medical history, concomitant medications were not reported.		200900792	1						2	Headache; Myalgia; Nausea; Vomiting	ANTH~UNKNOWN MANUFACTURER~FAV149~UNK~SC~UN~ANTHRAX (NO BRAND NAME)~2|FLUN3~MEDIMMUNE VACCINES, INC.~500556P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|SMALL~EMERGENT BIOSOLUTIONS~VV04003A~UNK~ID~UN~SMALLPOX (ACAM2000)~2	USA	Hospitalisation	Influenza
0334621	04/27/2009		18.0			M	02/27/2009	This case was received on 23 February 2009 via a QScan search on the VAERS database, under reference number 334621. An 18-year-old male patient, whose medical history was not reported, received the following vaccinations on 31 October 2008: SMALLPOX vaccine (trade name and manufacturer unknown, lot number not reported), TYPHIM VI (lot number B03472), ANTHRAX vaccine (trade name and manufacturer unknown, lot number not reported) and FLUMIST (Medimmune Vaccines, lot number 500549P). On an unspecified date, the patient developed the following symptoms: nausea with vomiting, chest pain, flu-like illness, mild headache, cough, sore throat and general body achiness. After an unspecified amount of time, he felt well, but the symptoms returned and included chest pain on 26 November 2008. On 29 November 2008, 29 days post-vaccination, the patient was hospitalized with flu-like symptoms and chest pain. The diagnosis was acute myopericarditis. Laboratory and diagnostic test results included the following: ejection fraction, decreased; troponin, increased; cardiac enzymes, increased; echocardiogram, abnormal; electrocardiogram, ST-T change. Corrective treatment and outcome were not reported. NOTE: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed SMALLPOX vaccine at the time of the patient's vaccination.					Y	0				10/31/2008	11/29/2008	29	ejection fraction, decreased; troponin, increased; cardiac enzymes, increased; echocardiogram, abnormal; electrocardiogram, ST-T change	MIL	MIL			Medical history, concomitant medications, and illness at time of vaccination were not reported.		200900662	1						2	Cardiac enzymes increased; Chest pain; Cough; Echocardiogram abnormal; Ejection fraction decreased; Electrocardiogram ST-T change; Headache; Influenza like illness; Myopericarditis; Nausea; Oropharyngeal pain; Pain; Troponin increased; Vomiting	ANTH~UNKNOWN MANUFACTURER~~UNK~SC~UN~ANTHRAX (NO BRAND NAME)~2|FLUN3~MEDIMMUNE VACCINES, INC.~500549P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|SMALL~EMERGENT BIOSOLUTIONS~~UNK~ID~UN~SMALLPOX (ACAM2000)~2|TYP~SANOFI PASTEUR~~UNK~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~2	USA	Hospitalisation	Influenza
0334666	04/27/2009		19.0			M	03/16/2009	This case was received on 23 February 2009 via a search on the VAERS database, under reference number 334666. A 19-year-old patient, whose medical history was not reported, received the following vaccinations on 21 November 2008: Smallpox vaccine (trade name and manufacturer unknown, lot number not reported), TYPHIM VI (lot number B03472), influenza vaccine (trade name and manufacturer unknown, lot number not reported), and HAVRIX (GSK, lot number AHAVB195AB). On 26 November 2008, five days post-vaccination, the patient was referred to an emergency room by his primary care physician for evaluation of smallpox vaccine inoculation site concerns and left axillary pain. The patient's symptoms included the following: flu-like symptoms less than 96 hours, chest pain, pain, erythema and pruritis. Lab test results were normal: Troponin, negative; CPK, normal; CPK-MB, negative; CBC, normal. Corrective treatment and recovery status were not reported. NOTE: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.									U	11/21/2008	11/26/2008	5	26 November 2008: Troponin, negative; CPK, normal; CPK-MB, negative; CBC, normal.	UNK	UNK			Medical history, concomitant medications, and illness at time of vaccination were not reported.		200900663	1						2	Axillary pain; Blood creatine phosphokinase MB normal; Blood creatine phosphokinase normal; Chest pain; Erythema; Full blood count normal; Influenza like illness; Pain; Pruritus; Troponin	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB195AB~UNK~IM~UN~HEP A (HAVRIX)~2|SMALL~EMERGENT BIOSOLUTIONS~~UNK~ID~UN~SMALLPOX (ACAM2000)~2|TYP~SANOFI PASTEUR~B03472~UNK~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~2	USA		Influenza
0344905	04/27/2009	NY	1.0			M	04/24/2009	Information has been received from a consumer concerning her approximately 12 month old male with food allergies and no pertinent medical history who in approximately 2005 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown).  Secondary suspect therapy included a dose of PEDVAXHIB (OMPC) (manufacturer unknown).  Concomitant therapy included a dose of INFLUENZA virus vaccine (unspecified) (manufacturer unknown), a dose of DTAP+HEPB+IPV (manufacturer unknown) and a dose of PREVNAR.  All the vaccines were given in his first year of birth.  After receiving the vaccines the patient did not respond to his name, stared at the fan, delayed speech and flapping.  Unspecified medical attention was sought and unspecified lab work was performed but no results provided.  The consumer reported that at 26 months of age the patient was diagnosed in the autism spectrum, but the patient had improved.  Follow up information was received from a receptionist who indicated that the responsible physician retired about 6 years ago.  Upon internal review, autism spectrum was determined to be an other important medical event.  Additional information has been requested.									N		06/01/2007		Unknown	OTH	OTH		Food allergy			WAES0904USA02827	1						1	Abnormal behaviour; Autism spectrum disorder; Speech disorder developmental; Staring; Unresponsive to stimuli	DTAPHEPBIP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP + HEPB + IPV (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~MERCK & CO. INC.~~UNK~UN~UN~HEP B (RECOMBIVAX HB)~1|HIBV~MERCK & CO. INC.~~UNK~UN~UN~HIB (PEDVAXHIB)~1|PNC~PFIZER\WYETH~~UNK~UN~UN~PNEUMO (PREVNAR)~1	USA		Influenza
0344921	04/27/2009	OH	42.0	42		M	04/27/2009	Reaction to small pox lot number VV04003A. Pt. Developed rash covering entire body 6 days after vaccination. Pox fully formed then reaction occurred. Rash is still ongoing pt on day 2 receiving care.				Y					U	04/19/2009	04/25/2009	6	Lab tests running at this time	MIL	MIL	Amoxicillin.	Sinus infection				1						1	Laboratory test; Rash generalised	ANTH~EMERGENT BIOSOLUTIONS~FAV149~1~IM~RA~ANTHRAX (BIOTHRAX)~1|FLU3~CSL LIMITED~03149111A~5~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|TYP~SANOFI PASTEUR~A0522~3~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0344932	04/27/2009	CA	40.0	40		M	04/27/2009	After I received the flu shot I developed sever numbness on my extremities witihn 2-3 weeks. After that I developed severe weakness, loss of motor power mostly on the right hand and leg, tachycardia, sever muscle twitches, contracture on right lower extremity, difficulty breathing because of tachycardia. I was diagnosed as Acute dissemintaed encephalomyelitis (ADEM) and my Brain MRI showed diffuse demyelinization of the brain. I recovered mostly. I report this after I finished my follow up with neurology departmnts to make sure it is not a presentation of MS. I received 2 courses of steroids meanwhile that was not helpful. I still have numbness on my right leg and foot and muscle twitches.  5/28/09 Medical records received DOS 3/11/08 to 2/2/09. FINAL DIAGNOSIS: Acute disseminated encephalomyelitis, cervical stenosis. Post vaccination presented with numbness of hands feet face. Generalized weakness and fatigue. Shortness of breath, tachycardia, PVCs. Multifocal muscle twitching.   6/8/09 Hospital record (Multiple Sclerosis Center) received DOS 4/1/09. FINAL DIAGNOSIS: Acute disseminated encephalomyelitis, cervical stenosis. Follow up exam received. No new codes other than patient reports uveitis treated with prednisone eye drops in June 2008 and pericarditis treated with ibuprofen in July 2008.\ksk				Y				Y	N	10/17/2007	11/01/2007	15	Lumbar puncture 2 times within 9 months interval was negative for possible MS panel. Four more Brain MRIs were negative for new lesions. EMG and NCV were Normal. Visual evoked potential was normal. Lumbar puncture did not show any elevated protein or WBC.  5/28/09 Medical records received DOS 3/11/08 to 2/2/09. LABS and DIAGNOSTICS: MRI - spinal stenosis. Holter Monitor - PVCs.  Numerous lab and other diagnostic studies are WNL.	UNK	UNK	omeprazole , Simvastatin. 5/28/09 Medical records received DOS 3/11/08 to 2/2/09. omeprazole, simvastin, clonazepam, acetaminophen, corticosteroids. Medical records received DOS 3/11/08 to 2/2/09. Prenisone eye drops, ibuprofen.	Hyperlipidemia , GERD	Medical records received DOS 3/11/08 to 2/2/09. Orchidectomy for undescended testicle. 6/8/09 Hospital record (Multiple Sclerosis Center) received DOS 4/1/09. Uveitis, Mycarditis.			1						1	Acute disseminated encephalomyelitis; Asthenia; CSF protein normal; CSF white blood cell count negative; Demyelination; Dyspnoea; Electromyogram normal; Extremity contracture; Hypoaesthesia; Lumbar puncture normal; Motor dysfunction; Muscle twitching; Nerve conduction studies normal; Nuclear magnetic resonance imaging brain abnormal; Tachycardia; Visual evoked potentials normal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~20832648~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0344947	04/27/2009	MO	57.0	57		M	04/20/2009	Flu like symptoms for two to three weeks. Numbness in feet - leg cramps - back pain in spinal area - problem walking (paralysis). Hospitalization - tests and treatment for Guillain-Barre (GBS) and acute rehabilitation - 30 day hospitalization.4/29/09-records received-for DOS 1/20-2/3/09-DC DX: Ascending motor sensory weakness secondary to Guillain-Barre Syndrome following recent viral respiratory tract illness 2-3 weeks prior to admission. Status post IVIG. Uncontrolled diabetes mellitus secondary to noncompliance with diet and medication. Hypertensive emergency improved. Ambulatory dysfunction secondary to gait instability. Hyponatremia. Hypokalemia. Presented with increasing gait instability and lower extremity paresthesia. Increased thirst, increased urination and fatigue. Numbness progressed to upper extremities, right facial weakness, difficulty swallowing and some dyspnea			Y	Y	Y	30	Y		U	10/13/2008	12/20/2008	68	Hospitalization and Tests 1-21-09 4/29/09-records received-UA glucose 1000 and more than 80 ketones and 100mg/dl protein. Hemoglobin A1c 10.9. MRI brain mild atrophy. MRI thoracic spine unremarkable. MRI lumbar spine disk bulging. CSF cryptococcal antigen negative and counts benign. Hepatitis B surface antigen surface antibody positive.	PUB	OTH		None 4/29/09-records received-recent viral respiratory tract illness 2-3 weeks prior to admission.	None 4/29/09-records received- PMH:testicular cancer. Chronic alcohol use.			1						1	Back pain; Gait disturbance; Guillain-Barre syndrome; Hypoaesthesia; Influenza like illness; Laboratory test; Muscle spasms; Paralysis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8788205~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0344957	04/27/2009	CA	50.0	50		M	04/22/2009	Received Flu and PNEUMOVAX 3/24/09 one in each deltoid. Pain since - Limited range of motion, very painful. Referred to physical therapy - Given pain meds. Last seen 4/21/09									Y	03/24/2009	03/24/2009	0		PUB	PUB	Risperidone 2mg; HYLO #3	HTN	Liquid Iodine (X-ray contrast)			1						1	Joint range of motion decreased; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1163X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0345053	04/28/2009	TX	68.0	68		M	04/28/2009	Patient (68 year old male) received a flu shot on 10/10/07.   He died that night in his sleep of a massive heart attack, presumably in the early morning hours of 10/11/07.   Although previously diagnosed with mild artherosclerosis, he had never had a prior heart attack.   He had just visited his doctor the previous day and been given a clean bill of health.  5/6/09 Autopsy report states COD as artherosclerotic & hypertensive-type cardiovascular disease w/obesity as contributing condition.  Manner of death natural.  Report also states 40-50% stenosis of LAD by calcified atherosclerotic plaque; atherosclerosis of aorta; cardiomegaly; obesity, BMI 34; hx of hypercholesterolemia; mild pulmonary edema/congestion; prostatic nodular hyperplasia; hx of seizure disorder.	Y	10/11/2007							N	10/10/2007	10/11/2007	1	Coroner's report conludes he died as the result of artherosclerotic and hypersensitive-type cardiovascular disease, with obesity as a contributory condition.	UNK	UNK	Lamictal - 100 mg/day as of 9/14/07; Zocor 20 mg/day; also on Vytorin 10/20 p.o. daily ?	none	artherosclerosis, obesity, mild epilespy, CAD with mildly elevated calcium score			1						1	Autopsy; Death; Myocardial infarction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA037AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Results in Death	Influenza
0345059	04/28/2009	TX	60.0	60		F	04/28/2009	Client received the influenza, pneumococcal (PPV23), Tdap, MMR, Hepatitis A, Hepatitis B, and shingles Vaccine at 10:10 a.m. at clinic. Client then went to another clinic to get the influenza Vaccine at 2:15p.m. She was consequently also administered the Varicella Vaccine at 2:15 p.m.  Client noticed that she began having wheals (hives) on the left side of abdomen on Sunday, April 26, 2009 at 9:00 a.m. Client had itching (4 on a scale from 0-10). Pain level report at 2-3 on scale 0-10. The lesions were in a area four inches in diameter. On April 28, 2009 the hives spread to over 12 inches in diameter, somewhat confluent fashion. The lesions appear mainly on the left side of abdomen. There are no lesions on the back or any other area of the body except the abdomen area. Client used body lotion on the lesions and it helped with the itching. Client also took warm baths and it appeared to stop the itching. Client referred to medical provider for consultation.									U	04/22/2009	04/26/2009	4		UNK	UNK	N/A	N/A	1991 client had an allergic reaction to codeine; gave client massive headache. 1988, Cortisol shot gave client reaction; client suffered pain all over body.	N/A~ ()~~0.00~Patient|N/A~ ()~~0.00~Sibling|N/A~ ()~~0.00~Sibling		1						1	Pain; Pruritus; Urticaria; Pain of skin; Pruritus; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89684~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~MERCK & CO. INC.~0399X~1~IM~LA~HEP B (RECOMBIVAX HB)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB252AA~1~IM~RA~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1582X~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PPV~MERCK & CO. INC.~0380U~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C3029AA~1~IM~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~055Y~1~SC~LA~VARICELLA (VARIVAX)~1|VARZOS~MERCK & CO. INC.~1730X~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1|VARCEL~MERCK & CO. INC.~~UNK~UN~UN~VARICELLA (VARIVAX)~2|VARZOS~MERCK & CO. INC.~1730X~UNK~SC~UN~ZOSTER LIVE (ZOSTAVAX)~2	USA		Influenza
0345071	04/28/2009	FL				M	04/28/2009	This case was reported by a lawyer and described the occurrence of Guillain-Barre Syndrome in an adult male subject who was vaccinated with INFLUENZA (manufacturer unspecified). A physician or other health care professional has not verified this report. The following information was obtained from a legal complaint. In December 1996 the subject received an unspecified dose of INFLUENZA (unknown). At an unspecified time after vaccination with INFLUENZA vaccine, the subject developed an acute and chronic form of GBS syndrome known as chronic inflammatory demyelinating polyneuropathy (CIDP). The subject reportedly has suffered from this chronic form of GBS/CIDP for years and will continue to suffer from this disease for the rest of his life. The complaint further alleged that the subject suffered bodily injury resulting in physical pain and suffering, disability, disfigurement, mental anguish, loss of capacity for the enjoyment of life, the expenses of hospitalization and medical care and treatment, loss of earnings in the past, and loss of the ability to earn money in the future. At the time of reporting the events were unresolved.					Y	0		Y	N	12/01/1996			UNK	OTH	OTH		Unknown	The subject's medical history, concurrent medical conditions, and concomitant medications were not specified.		A0780839A	1						1	Activities of daily living impaired; Anxiety; Chronic inflammatory demyelinating polyradiculoneuropathy; Deformity; Guillain-Barre syndrome; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0345076	04/28/2009	CA	51.0	51		F	04/25/2009	Received Flu Vaccine on Oct. 10, 2008. 5 days later began fatigue which progressed to anaphylaxis, episode 1 on October. Received corticoteroids. Episode 2 anaphylaxis occurred Nov 5. Serious immune system overdrive. Caused first flare of either SLE or RA - tests confirmed +RF -. 5/8/09 - Medical records received DOS 10/30/08 to 1/22/09 FINAL DIAGNOSIS: Recurrent urticaria, migraine-like experience Neurological consult DOS 12/5/09: Urticaria associated with anaphylaxis. Nausea and photosensitivity. On this date PE WNL. Rheumatology consult DOS 1/8/09-1/22/09: C/O Blurred vision. Tingling in arms and feet. Anxiety, panic episode. Fullness and swelling in the supraclavicular area. Pseudocholinesterase deficiency. PE WNL.   5/11/09 - ED records recieved DOS 10/30/09.   FINAL DIAGNOSIS: Allergy Headache, itchy patches on right shoulder and left forearm. Lightheadedness. Small open lesions on upper back and neck. Double vision right eye. Advise cardiology and neurology consults.				Y				Y	N	10/10/2008	10/30/2008	20	FBC; Tests for Autoimmune disease; in all 37 tests from October 30 - January 5th 2009 5/8/09 - Medical records received DOS 10/30/08 to 1/22/09 LABS and DIAGNOSTICS:  CBC - RBC 3.94 M/uL (L)  MCH 32.7 PG (H)  Monocytes 11.4% (H) Rheumatoid profile negative. MRI - no significant findings. MR Angiogram - No significant findings./ LABS and Diagnostics: CT of head is negative. MRI - 2 areas of lacunar CVA.  MRA - WNL. Blood chemistry normal./	UNK	UNK						1						1	Anaphylactic reaction; Fatigue; Full blood count; Immunology test	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0345084	04/28/2009	TX	41.0	41		M	04/28/2009	None stated										04/28/2009				PVT	UNK		None	None			1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA389BA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB302BA~UNK~UN~LA~HEP A (HAVRIX)~1	USA		Influenza
0345101	04/28/2009	IL	31.0	31		F	04/23/2009	None stated.										04/23/2009				UNK	UNK						1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89684~2~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0345102	04/28/2009	FL	81.0	81		F	04/28/2009	2 days later had bad stiffness on back of neck and then it went down both sides of torso.  Called doctor but said not related to vax.  Pain on back subsided after a week; however it made hernia worse to the point that required surgery on 3/4/09.  Weeks after surgery fell backwards and fractured right hand in landing.									U	10/01/2008				PVT	PUB	Cintrold, red yeast rice.	No	Hernia in stomach.  Allergic to VICODEN; TAXOL; TALWIN; CITRICAL; CENTRUM SILVER	Flu like symptoms~Influenza (Seasonal) (no brand name)~UN~0.00~Patient		1						1	Back pain; Condition aggravated; Fall; Hand fracture; Hernia; Musculoskeletal stiffness; Surgery	FLUX~UNKNOWN MANUFACTURER~~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0345104	04/28/2009	TX	44.0	44		M		None Stated										04/20/2009				UNK	UNK						1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2749AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0345157	04/29/2009		18.0	18		M	04/28/2009	This report was received from a health care professional on 16 April 2009, and refers to a serious adverse event experienced by a subject participating in a study. A previously healthy 18-year-old male subject received study product FLUZONE SV 2008-2009 (lot not reported) on 03 November 2008. On 01 December 2008, 28 days post-vaccination, he presented to the emergency room with right lower quadrant pain and nausea. A CT of the abdomen revealed a normal proximal appendix; the distal portion of the appendix could not be visualized. A focal region of the peritoneal fat stranding and free fluid, noted to be secondary signs of appendicitis, were observed. The subject underwent an appendectomy, and histopathology diagnosis was follicular lymphoid hyperplasia of the appendix and omental infarct with fat necrosis. He was discharged from the hospital on 02 December 2008, and prescribed VICODIN as needed for pain. Outcome was not reported. According to study investigator, the event was unrelated to FLUZONE.					Y	1			Y	11/03/2008	12/01/2008	28	02/Dec/2008: CT of the abdomen revealed a normal proximal appendix; the distal portion of the appendix could not be visualized. A focal region of peritoneal fat stranding and free fluid, noted to be secondary signs of appendicitis, were observed. Histopathology diagnosis: follicular lymphoid hyperplasia of the appendix and omental infarct with fat necrosis.	UNK	UNK			Previously healthy.		200901700	1						1	Abdominal pain lower; Appendicectomy; Appendicitis; Computerised tomogram abnormal; Fat necrosis; Infarction; Lymphoid hyperplasia of appendix; Nausea; Abdominal pain lower; Appendicectomy; Appendicitis; Computerised tomogram abnormal; Fat necrosis; Infarction; Lymphoid hyperplasia of appendix; Nausea	FLU3~SANOFI PASTEUR~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0345173	04/29/2009	MO	34.0	34		M	04/29/2009	The first signs begin with a pain in my right arm three-four days after my vaccine.  I was not able to raise it above my head.  The pain moved to my shoulder and across to my other arm.  I went to an ER a week after my vaccine and they did blood and a mono test but all came back normal and prescribed ibuprofen.  Within the next week I began having difficulty walking and going up stairs.  I notice pins and needs along with numbness in my toes.  I went to another ER exactly a week following the first visit. They did additional blood test (CBC) and it came back normal.  My blood pressure was high when I came in but it went back down to normal.  They recommended a brain MRI to rule out MS.  However, they stated it would have to be done by my PCP.  I went the following week to my primary care physician and he wanted to do additional blood work prior to a brain MRI. He noticed I did not have any reflexes. He did tests for lupus, Lyme disease, metal, HIV.  After a week waiting, all tests came back negative. At this point numbness, weakness and pins and negatives moved to my fingers and my legs.  I went to a third ER a week after the PCP visit.  They did some additional tests and were led to believe it was Guillain Barre.  They admitted me that night.  They following day I had a Brain MRI, Spinal tap and EMG. The Brain MRI came back negative.  The Spinal tap showed high protein but ruled out meningitis. The EMG showed a decrease in the number of motor units. I was diagnosed with GBS.  They began treating me with IV/IG over the course of 5 days. Physical and Occupational therapy began and I have been doing that ever since. I still have pain and swelling in feet. Have abnormal gait along with balance issues and struggle climbing stairs. I am taking Gabapentin and Hydrocodone for the pain and neuropathy. Records received - 05/04/2009, hosp admission 11/24/2008 to 11/30/2008.  Patient previously seen and discharged by two other ED's.  Admitted for evaluation of progressive weakness and paresthesias post influenza vaccination, inability to climb stairs, difficulty standing.  Areflexa of patellar and Achilles reflex. Bilateral diminished grip strength and lower extremity strength. gross motor and sensory intact.  Diagnosis: Guillain-Barre' syndrome - to follow up with neurologist. Hypertension - to follow up with primary care physician.   Follow-up received on May 11, 2010 states pt did not recover from the adverse events that were reported for this vaccination. Had a relapse still have neuropathy in feet. Pain and numbness. Taking steroids to keep strength.				Y	Y	6			N	10/29/2008	11/02/2008	4	Mono Test negative; Completed all blood tests, Lyme Disease Negative; Heavy Metal Negative, HIV Negative, Brain MRI was normal; Spinal Tap showed high count of protein >100.  EMG showed a decrease in the number of motor units. Labs:   Hematology: Low MCV, MPV, High monocytes. High RBC, Hb  Blood chemistry: Calcium high  Cardiac markers: Creatine kinase high  CSF: RBC's present, protein elevated 189 mg/dL  Normal CXR  Normal MRI head  Normal lower extemity sonogram	UNK	UNK	None	None	Asthma from 5-13 years of age.  Allergic to penicillin, solumendrol and decadron.	None~ ()~~0.00~Patient		1						1	Areflexia; Balance disorder; Blood heavy metal normal; Blood product transfusion; Blood test normal; Borrelia burgdorferi serology negative; CSF protein increased; Electromyogram abnormal; Gait disturbance; HIV test negative; Hypertension; Hypoaesthesia; Injected limb mobility decreased; Lumbar puncture; Mononucleosis heterophile test negative; Muscular weakness; Musculoskeletal pain; Neuropathy peripheral; Nuclear magnetic resonance imaging brain normal; Oedema peripheral; Pain; Pain in extremity; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89685~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0345195	04/29/2009	TX	45.0	45		F	04/27/2009	Pt stated arm was sore for 3 days. Then in a week she started having spasms in her arm that continue to happen at night still.  Has gotten a steroid shot.				Y					N	10/08/2008	10/09/2008	1		OTH	PVT						1						1	Muscle spasms; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89685~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0345254	04/30/2009	MI	46.0	46		F	04/28/2009	This case was received from a health professional on 07 November 2008, and represents a cluster of 20 patients. Twenty patients, all employees of a health care facility, reported experiencing adverse reactions after receiving intramuscular injections of FLUZONE SV 2008-2009 (lot number U2762AA). Following vaccination, one female patient self diagnosed herself with ocular respiratory syndrome. One female patient complained of pain in the vaccinated arm, with ongoing difficulty lifting the arm. Two patients complained of itch and hives. Eleven patients had body aches, chills, and fever six to twelve hours after vaccination; seven of those eleven patients missed one day of work. Five patients reported pain at the injection site, radiating to the neck and down to the fingers. Individual identifiers were not provided, and outcome was unknown. Follow-up information was received from the health care professional on 13 January 2009, and provided patient identifiers for each of the patients reported in the original case. This case now pertains only to a female patient who complained of both arms itching profoundly on 14 October 2008 (date of vaccination not reported). Treatment included CLARITIN and hydrocortisone. Outcome was not reported. Follow-up information received on 13 February 2009 from a health care professional. The patient had been vaccinated with a prior dose of flu vaccine (Trade name, manufacturer name, route and site not provided) in 2002 and experienced a rash and itch. The patient was 46-years-old at the time of vaccination with FLUZONE SV 2008-2009 on 14 October 2008. The FLUZONE was administered in the deltoid. The patient recovered; however a recovery date was not provided. No further information is expected. Follow up information received on 20 April 2009 from a health care professional. Based upon new information, this case meets seriousness criteria and has been upgraded to serious. On 14 October 2008, the patient medicated with PEPCID and Prednisone prior to administration of FLUZONE SV 2008-2009 which was administered in the right deltoid, indication not reported. Within hours, the patient developed a rash from head to toe and had to leave work. The patient went to the doctor's office and was prescribed a SOLUMEDROL dose pack, PEPCID, and BENADRYL. The rash lasted for two days and the patient made a full recovery. The patient was instructed to avoid future flu vaccinations. This patient is one of a cluster of 20 patients. The other 19 patients are captured in case numbers 2009-00153 through 2009-00171, and case. The patient also has another adverse event that is reported in case 2009-00681. Documents held by sender: None.				Y					Y	10/14/2008	10/14/2008	0	Not reported	PVT	PVT	PEPCID; Prednisone		The patient had received a flu vaccine (trade name, manufacturer name not provided) in 2002 and experienced a rash and itch.  The patient recovered.		200803509	1						1	Pruritus; Rash generalised; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U2762A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0345321	04/30/2009	CA	1.01	1	.0	F	04/26/2009	Patient developed severe systemic rash, elevated temperature, continuous crying, inability to sleep. A month later patient stopped smiling, and developed severe diarrhea enlarged abdomen, shortly after, patient stopped babbling, or engaging and has been diagnosed with PDD.  6/25/09 Vaccine and medical records received DOS 11/13/06. Well child visit. Hemangioma noted on labia major and scalp.				Y				Y	N	11/13/2006	11/14/2006	1	Lab test showing viral encephalopathy, chronic colitis, mercury poisoning	PVT	OTH	None	Child sick; 9/12/06-Hep B given	No	~DTP + IPV + Act-Hib (no brand name)~1~0.00~Patient|~DTP + IPV + Act-Hib (no brand name)~1~0.00~Sibling		1						1	Abdominal distension; Autism spectrum disorder; Body temperature increased; Colitis; Crying; Diarrhoea; Disturbance in social behaviour; Encephalopathy; Laboratory test abnormal; Metal poisoning; Rash; Sleep disorder; Speech disorder	FLUX~SANOFI PASTEUR~U2191BA~2~UN~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~SANOFI PASTEUR~UE719AA~3~UN~LL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0986F~1~UN~RL~MEASLES + MUMPS + RUBELLA (MMR I)~1|PNC~PFIZER\WYETH~1308681F~4~UN~RL~PNEUMO (PREVNAR)~1	USA	Disabling	Influenza
0345324	04/30/2009	MD	1.1	1	.1	F	04/30/2009	Child received above listed vaccines 11-20-08 at routine WCC visit at 12 noon. Child developed tactile temp 11-21-08 around 1pm followed by pruritus & hives on face, back, legs. Child was concurrently less active, more sleepy. T 100.7 at 19:41 at presentation to ED. Exam revealed wheals & decreased activity - nontoxic appearance. BENADRYL administered also TYLENOL.				Y					Y	11/20/2008	11/21/2008	1	CBC, 11-20-08, WBC, 4.9, RBC, 4.31, plate, 203K, Hb, 11.3, Hct, 35.8, Lymph, 68.8%, Mono, 3%, N, 13.9%, E, 52%, B, 0.8%	PVT	PUB	EPIVIR; KALETRA; ZERIT; TMP/SMZ	HIV-VLR50; CD4 Abs 1221	HIV-Perinatal; Neonatal drug exposure; NKA			1						1	Basophil percentage; Body temperature increased; Decreased activity; Eosinophil percentage increased; Haematocrit normal; Haemoglobin normal; Lymphocyte percentage increased; Monocyte percentage; Neutrophil percentage decreased; Platelet count normal; Pruritus; Red blood cell count normal; Somnolence; Urticaria; White blood cell count decreased	DTAP~SANOFI PASTEUR~U2156CB~4~IM~UN~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U2797FA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~U194BA~3~IM~UN~HIB (ACTHIB)~1|MMRV~MERCK & CO. INC.~0869U~1~SC~UN~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PNC~PFIZER\WYETH~B54013B~4~IM~UN~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0345337	04/30/2009	KY	1.0	1	.0	M	04/24/2009	Child developed chicken pox disease - in clinic 4-24-09.									U	10/02/2008			None	PUB	PUB	None	None	Failure to thrive			1						1	Varicella	FLU3~SANOFI PASTEUR~U2811AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB247AA~1~IM~UN~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0908X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C73446~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0992Y~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0345343	04/30/2009	CT	4.0	4		M	04/24/2009	Right arm immunization site reaction 4cm X 6cm erythematous area on upper right arm. Warm, clearly demarcated area, tender to touch, no streaking. Similar 1X1 cm area on upper left arm. Augmentin X 7 days.				Y					Y	02/25/2009	02/27/2009	2		PUB	PUB		Proteinuria	Obesity			1						1	Injection site erythema; Injection site pain; Injection site warmth	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B084AB~1~IM~RA~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~U2847AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1079X~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1398X~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0346035	04/30/2009	CA				U	04/15/2009	This case was reported by a pharmacist and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with (FLULAVAL, GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced injection site pain. At the time of reporting the outcome of the event was unspecified.									U				UNK	OTH	OTH		Unknown			A0768956A	1						1	Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA179AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0346036	04/30/2009	SD	19.0	19		M	04/15/2009	This case was reported by a healthcare professional and described the occurrence of wrong route of administration in a 19-year-old male subject who was vaccinated with FLULAVAL, GlaxoSmithKline. Concurrent medical conditions included drug allergies to AMOXICILLIN, penicillin, and ROBUTUSSIN. The subject is a smoker. There were no concurrent medications. On 7 January 2009 at 13:30 the subject received a dose of FLULAVAL at 0.01 ml, intradermally, in the left forearm. This was the wrong route of administration and an inappropriate dose of drug administered. The nurse administering FLULAVAL was thinking about how purified protein derivative is given instead of the way flu vaccine should be given. Following administration of FLULAVAL, the subject developed a local reaction immediately, which was defined as within one hour. The reaction consisted of a 2cm by 2cm area of redness and swelling. The area was also inflamed. The events were not resolved at the time of reporting and were being monitored and measured. No treatment was required. In the reporter's opinion, the events were probably related to treatment with FLULAVAL. The invalid FLULAVAL dose was repeated at the full 0.5 ml dose and was given via the appropriate intramuscular route. The repeat dose was given in an unknown deltoid muscle and there were no reactions reported.  The reporter did not know if the repeat dose of FLULAVAL was administered in the same arm as the invalid dose or the opposite arm.				Y					N	01/07/2009	01/07/2009	0	Unknown	PUB	PUB		Drug allergy; Smoker	The subject has known allergies to amoxicillin, penicillin and ROBITUSSIN.		A0763053A	1						1	Immediate post-injection reaction; Incorrect dose administered; Incorrect route of drug administration; Injection site erythema; Injection site inflammation; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA172AA~UNK~ID~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0346037	04/30/2009	SD	19.0	19		M	04/15/2009	This case was reported by a healthcare professional and described the occurrence of wrong route of administration in a 19-year-old male subject who was vaccinated with FLULAVAL, (GlaxoSmithKline).  There were no concurrent medications.  On 7 January 2009 at 13:30 the subject received a dose of FLULAVAL at 0.01 ml, intradermally, in the right arm.  This was the wrong route of administration and an inappropriate dose of drug administered.  The nurse administering FLULAVAL was thinking about how purified protein derivative is given instead of the way flu vaccine should be given.  Following administration of FLULAVAL, the subject developed a local reaction immediately, which was defined as within one hour.  The reaction consisted of a 2cm by 2cm area of redness and swelling.  The area was also inflamed.  The events were not resolved at the time of reporting and were being monitored and measured.  No treatment was required.  In the reporter's opinion, the local reaction and redness were probably related to treatment with FLULAVAL.  The invalid FLULAVAL dose was repeated at the full 0.5 ml dose and was given via the appropriate intramuscular route.  The repeat dose was given in an unknown deltoid muscle and there were no reactions reported.  The reporter did not know if the repeat dose of FLULAVAL was administered in the same arm as the invalid dose or the opposite arm.				Y					N	01/07/2009	01/07/2009	0	UNK	PUB	PUB	No concurrent medication	Unknown	The subject has no documented history of adverse events following previous flu shots.		A0763059A	1						1	Incorrect dose administered; Incorrect route of drug administration; Injection site erythema; Injection site inflammation; Injection site swelling; Local reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA172AA~UNK~ID~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0346038	04/30/2009		58.0	58		M	04/15/2009	This case was reported by a consumer and described the occurrence of watery eyes in a 58-year-old male subject who was vaccinated with (FLULAVAL, GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject has had flu vaccinations in the past, but is unsure which vaccines they were. The subject did not experience any reactions with previous flu shots. The subject had no adverse events following previous vaccinations. On 14 October 2008 the subject received unspecified dose of FLULAVAL (.5 ml, unknown, left arm). On 16 October 2008, 2 days after vaccination with FLULAVAL, the subject experienced watery eyes. According to the reporter, all diagnostic tests so far have been negative; no glaucoma and no blocked tear ducts. At the time of reporting the event was unresolved.				Y					N	10/14/2008	10/16/2008	2	According to the reporter, all diagnostic tests so far have been negative; no glaucoma and no blocked tear ducts.	PUB	PUB		Unknown	The subject has had flu vaccinations in the past, but is unsure which vaccines they were. The subject did not experience any reactions with previous flu shots, The subject had no adverse events following previous vaccinations.		A0765124A	1						1	Lacrimation increased; No reaction on previous exposure to drug	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA172AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0346039	04/30/2009	ID				U	04/15/2009	This case reported by a healthcare professional via a sales representative and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with (FLULAVAL, GlaxoSmithKline). In 2008 the subject received unspecified dose of FLULAVAL (.5 ml, unknown, unknown arm). On an unspecified date in the fall of 2008, at an unspecified time after vaccination with FLULAVAL, the subject experienced injection site reaction, pain, small local reaction and nonspecific reaction. At the time of reporting the injection site reactions, pain and small local reaction were improved. The events improved in possibly a week or more. Outcome of nonspecific reaction was unspecified. This facility vaccinates long term care subjects. They stated to sales representative that they have had a lot of reactions this year and were wondering if it was because we had some type of preservative that other companies do not. When we asked if they felt this was a bad lot, the sales representative said no. The healthcare professional considered the injection site reaction, pain and small local reaction was probably related to vaccination with FLULAVAL. Causality was unspecified fro nonspecific reaction.									U				UNK	OTH	OTH		Unknown	Medical history and if there were any adverse events following previous vaccinations was unknown.		A0765338A	1						1	Injection site pain; Injection site reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA187AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0346040	04/30/2009	FL	75.0	75		M	04/15/2009	This case was reported by a consumer and described the occurrence of itchy rash in a 75-year-old male subject who was vaccinated with (FLULAVAL, GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included pneumonia. Concurrent medical conditions included high blood pressure and high cholesterol. Concurrent medications included Aspirin (Baby aspirin), Lisinopril, Lovastatin and Doxycycline. On 5 November 2008 at 09:00 the subject received a dose of FLULAVAL left arm. On 7 November 2008, two days following vaccination with FLULAVAL, the subject developed an itchy rash all over his body. The subject was treated with CLOBEX, unknown medication (BENOS), PREDNISONE and methylprednisolone, but none of these treatments helped the rash. The consumer reported that the rash flares up on different parts of his body and becomes worse at times. The subject stated that his looked like GROVERS disease. The subject discontinued possible allergens such as artificial sweetener, but the rash is not improving and remains unresolved.				Y					N	11/05/2008	11/07/2008	2	UNK	PVT	PVT	Aspirin; Lisinopril; Lovastatin; Doxycycline	High blood pressure; High cholesterol	Pneumonia; It was reported by the subject that he has had previous flu shots with no reactions. Additionally, he reported no history of adverse events following previous vaccinations. In October 2008, the subject became ill with pneumonia and was started on Doxycycline 100mg for 10 days.		A0777619A	1						1	Rash pruritic	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA168AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0332694	05/01/2009	MN	2.0	2	.0	M		A serious spontaneous report of ataxia, left sided hemiparesis, slurring speech, tremors, rolling tongue, impairment in walking and talking, nausea/vomiting has been received from a consumer concerning a 24-month-old male, subsequent to FLUMIST.  The patient's past medical history includes egg allergy.  Reporter states no concomitant medications at the time of FLUMIST administration.  Patient is current with childhood immunizations and no immunizations given with FLUMIST.  The patient received FLUMIST 07-Nov-2008 at his two-year-old wellness visit.  Within a few hours after administration, the patient exhibited the above events.  The patient was hospitalized for two days.  The reporter stated that the discharge diagnosis listed ataxia and possible FLUMIST reaction.  FLUMIST was discontinued at this time.  Subsequently, the patient started taking supplements (eg. selenium, acidophilus).  In March 2009, the patient exhibited the same symptoms again and was hospitalized again.  Reporter states last dose of FLUMIST was 07-Nov-2008.  Currently, the child is at home with no symptoms.  A local neurologist at the hospital is following the patient.					Y	0			Y	11/07/2008	11/07/2008	0		OTH	OTH	Concomitant Drug(s) Not Used	Egg allergy	Egg allergy dx 2007; current on all childhood immunizations; 5-month-old brother in good health.		MEDI0008325	1						2	Ataxia; Dysarthria; Gait disturbance; Hemiparesis; Nausea; Speech disorder; Tongue disorder; Tremor; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Hospitalisation	Influenza
0345407	05/01/2009	ID	11.0	11		F	05/01/2009	Vomiting, indegestion, lack of appetite, weightloss, dizziness, abdominal pain, fever, fainting, listlessness and nausea.  This lasted from date of vaccine in January until end of March.She went to the Pediatrician three times, the Pediatric Gastroenteroligist, a Chiropractor and a surgeon.  She underwent two blood tests, had a stool sample, an ultrasound and a Endosopy with no results found.  She took several anti nausea vmiting medicines, took over the counter medications for her nausea and indigestion. 5/5/05 Records received DOS 1/7/09 to 3/7/09. Includes immunization records. FINAL DIAGNOSIS:  Post vaccination: Flu-like symptoms, fever, chills, nausea and vomiting. Diarrhea. Later developed epigastric pain. Foul smelling flatus. LABS: MCV low, Abdominal Ultrasound WNL  5/11/09 Gastroenterology records received DOS 2/9/09 to 2/19/09. FINAL DIAGNOSIS: Abdominal pain, nausea, vomiting Post vaccination: Flu-like symptoms, fever, chills, nausea and vomiting which subsided, followed one week later with recurrence of nausea, and development of epigastric abdominal pain, diarrhea. Progressed to persistant vomiting, epigastric pain, and severe nausea. Frequent foul smelling flatus.				Y					Y	01/07/2009	01/08/2009	1	Ultrasound, Endoscopy, Blood tests and stool sample 5/5/05 Records received DOS 1/7/09 to 3/7/09. LABS: MCV low, Abdominal Ultrasound WNL  5/11/09 Gastroenterology records received DOS 2/9/09 to 2/19/09. LABS and DIAGNOSTICS: Endoscopy with GI Biopsies, distal esophagus - mild chronic inflammation with rare eosinophils, stomach - WNL, duodenum - WNL.  Tissue transaminase - <3 (-).  Clotest/Helicobacter (-). IGA 85 MG/DL - WNL. Helicobacter Pylori Antigen - not detected.  Stool negative for Giardia lamblia.	UNK	UNK	None	None	Lactose intolerance, nocternal enuresis, hypothyroidism			1						1	Abdominal pain; Anorexia; Blood test; Dizziness; Dyspepsia; Endoscopy; Listless; Nausea; Pyrexia; Stool analysis; Syncope; Ultrasound scan; Vomiting; Weight decreased	FLUN3~MEDIMMUNE VACCINES, INC.~50057UP~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0572X~1~IM~RA~HPV (GARDASIL)~1|TDAP~SANOFI PASTEUR~C3027AA~2~IM~RA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1330X~2~~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0345441	05/01/2009	WA	2.0	2	.0	F	05/01/2009	Within 12 hours after admin of vaccines began vomiting Q 30 min- was taken to ED- called night clinic X2.				Y						04/29/2009	04/29/2009	0		PVT	PUB		None	None			1						1	Vomiting; Vomiting	FLU3~SANOFI PASTEUR~UT2794~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB28LBB~2~IM~LL~HEP A (HAVRIX)~1|FLU3~SANOFI PASTEUR~UT2794EA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB281BB~2~IM~LL~HEP A (HAVRIX)~2	USA	Emergency room visit	Influenza
0345455	05/01/2009	WA				U		Felts like open cut.  used rubbing alcohol to clean at home.  Has clear liquid at injection site after couple of days, then it scabbed over and got better.  No red or swollen, no fever Sx.									Y	12/02/2008	12/02/2008	0		UNK	PVT		None	None			1						1	Injection site extravasation; Scab	FLU3~SANOFI PASTEUR~U2803~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0345456	05/01/2009	MS	57.0	57		M	04/01/2009	Extreme swelling and redness of whole right upper arm for 3 weeks. Hives and welts everyday for several months, stomach shut down for about 3 weeks 1 time and 2 days another -still have hives and welts every 2-3 days. Seen Dr. for stomach (many test) still seeing Dr. for allergic reactions (Dr. swelling arm, red and fever).									U	10/29/2008				PVT	UNK						1						1	Erythema; Gastric disorder; Oedema peripheral; Pyrexia; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA367EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0978X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0345467	05/01/2009	WA	7.0	7		M	04/29/2009	Allergic reaction - hives - severe wheezing, breathing, throat.				Y					U	04/28/2009	04/28/2009	0		PVT	UNK		None	Asthma			1						1	Dyspnoea; Hypersensitivity; Throat irritation; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U2809AA8~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0345423	05/02/2009	NC	33.0	33		M	05/02/2009	Received vaccination 10/30/07; returned to doctor with pain in left shoulder (same as vaccinated arm) within two months; began experiencing pain, numbness, cognitive changes 5 months later w/no previous history; admitted to hospital after symptoms worsened; diagnosed with Multiple Sclerosis in 04/2008; no history of any autoimmune disorders in family.  5/14/09 Hospital records received DOS 4/3/08 to 4/4/08. FINAL DIAGNOSIS: C2-C3 demyelinating lesion, single white matter lesion in the subcortical U fibers of the left frontal lobe Post vaccination ascending numbness feet, torso, hands.  ICD-9 Codes: 341.9 Demyelinating diseases of central nervous system unspecified. 3488.8 Condition of brain. 477.9 Allergic rhinitis cause unspecified.  Follow-up received on May 10, 2010 - Pt did not recover from the adverse events that were reported for this vaccination. Multiple sclerosis - Permanently disabled.				Y	Y	3		Y	N	10/30/2007	01/02/2008	64	MRI, Blood Work, CT Scans, Lumbar Puncture, Neurological examinations.  5/14/09 Hospital records received DOS 4/3/08 to 4/4/08. LABS and DIAGNOSTICS: MRI Cervical Spine - flattening of cord at C5-C6, signal intensity C2-C3. MRI Thoracic Spine - Normal. CHEM - Gluc 109 MG/DL (H). CBC - MPV 7.2 FL (L). CSF Immunochemistry - Oligoclonal bands present. Viral Studies - EBV early Ab 112 Hf, EBV IgG 2238 Hf, EBV IgM Titer 15 f, EBV Nuclear Ag 1003 Hf.	UNK	UNK		Heel Pain	Seasonal allergies			1						1	Blood glucose normal; Blood test; CSF oligoclonal band present; Cognitive disorder; Computerised tomogram; Full blood count; Laboratory test; Lumbar puncture; Multiple sclerosis; Musculoskeletal pain; Neurological examination; Nuclear magnetic resonance imaging abnormal; Rhinitis allergic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~U2524AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation,Disabling	Influenza
0345530	05/04/2009		11.0			M	05/01/2009	Information has been received from a consumer concerning her son, an 11 year old male who was born prematurely and was diagnosed with cerebral palsy, who on an unspecified date was vaccinated with a dose of MMR II (lot # not reported). Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unknown), VAQTA (unspecified) (manufacturer unknown) and ROTATEQ (unspecified). It was reported that the patient were given a lot of vaccines for his age that included the MMR II. The patient's mother reported that the patient was diagnosed with autism later after receiving the MMR II. The patient sought an unspecified medical attention. At the time of reporting, the patient's outcome was Not Recovered/Not Resolved. Upon internal review, autism was determined to be an other important medical event. No further information is available.									N				Unknown	OTH	OTH		Cerebral palsy	Premature baby		WAES0904USA04222	1						1	Autism	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~MERCK & CO. INC.~~UNK~UN~UN~HEP A (VAQTA)~1|MMR~MERCK & CO. INC.~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|RV5~MERCK & CO. INC.~~UNK~UN~UN~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0345555	05/04/2009	WA	37.0	37		M		48 hrs - following vaccine, swelling distal to vaccination site - specifically dorsum of hand & wrist (left arm only); pain and reddish (blanching) discoloration. Symptoms & signs peaked at 3 days, resolving at day six.									Y	04/21/2009	04/23/2009	2	None	PVT	PVT		None	None			1						1	Arthralgia; Erythema; Joint swelling; Oedema peripheral; Pain in extremity; Pallor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA375AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|MNQ~SANOFI PASTEUR~U2845AA~UNK~UN~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TYP~SANOFI PASTEUR~D0251~UNK~UN~LA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0345592	05/04/2009	VA	26.0	26		F	05/04/2009	10/11/09 awoke with severe pain and weakness in Right deltoid.  Significant Pain and weakness continued for 2-3 days.  Then the pain decresed to moderate lasting 2 -3 weeks. Pain and weakness continue today when raising right arm. She is able to lift the same amount of weight with both arms but the right arm tires easily and she is unable to perform as many reps with the right arm.									N	10/10/2008	10/11/2008	1	none	UNK	PUB	Seasonique -  birth control   Maxalt	none	Metatarsis adductis - bilaterally			1						1	Injected limb mobility decreased; Muscular weakness; Pain in extremity	FLU3~SANOFI PASTEUR~u2789aa~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0345646	05/04/2009	CA	13.0	13		F	04/21/2009	Fever on 4-17-09, 7 PM. On 4-18-09 upon awakening had eyes swollen shut, face incl tongue puffy and red, eyes were also red. Facial swelling/redness resolved on 4-19-09 mid-day. Parent measured highest temp as 100.8. Seen in clinic 4-21-08, T 102, sneezing, nasal discharge, sore throat.									U	04/17/2009	04/17/2009	0	Quick viral strep (-); U/A dipstick; SC, 1015; ph 6; Tr leuk; Tr protein; Small blood	OTH	PUB	MOTRIN on 4-17-09; 4-19-09; 4-20-09; 4-21-09	None. T 98.3	Blisters on soles of feet 2' running (mild)		CA090003	1						1	Blood urine present; Erythema; Eye swelling; Ocular hyperaemia; Oropharyngeal pain; Protein urine present; Pyrexia; Rhinorrhoea; Sneezing; Specific gravity urine normal; Streptococcal identification test negative; Swelling face; Swollen tongue; Urine leukocyte esterase positive; pH urine normal	FLU3~SANOFI PASTEUR~U2898AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0650X~2~UN~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2844AA~UNK~UN~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2766AA~6~UN~LA~TDAP (ADACEL)~1	USA		Influenza
0345707	05/05/2009	IN	13.0	13		F	05/05/2009	Patient became lightheaded, pale, and unresponsive for approx. 1 minute. BP 90/48. Placed on couch w/ feet elevated. Given apple juice after alert & oriented x3. BP 98/60 prior to leaving office.									Y	05/05/2009	05/05/2009	0	None	PUB	PUB	None	None	None			1						1	Dizziness; Pallor; Unresponsive to stimuli	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89977~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|MNQ~SANOFI PASTEUR~U2826CA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0345724	05/05/2009	SD	24.0	24		F	05/05/2009	Pt presented for pre-travel vaccinations prior to travel.  Vital signs at presentation were as follows; B/P 120/62, T 97.7, R 12 and HR 60.  Cursory physical exam was accomplshed, nml heart and lungs.  Past medical hx of febrile seizures.  Pt was to receive four vaccinations; however, after receiving 1.0ml HAVRIX #1 and 0.5ml Fluzone separately (separated by 7cm) patient had a vasovagal episode, was laid supine, then after approx. 15 seconds she had a 15 second tonic-clonic seizure episode.  She fully recovered, with HR 68 and B/P 120/70 after episode.  After resting for 20 minutes, waited for another 10 minutes and was sent by POV to emergency room and had a normal work-up.  Believed to be secondary to prior hx of seizure (none related to prior vaccinations).  Talked to mother of patient this morning and patient is feeling well.				Y					Y	05/04/2009	05/04/2009	0	None accomplished in emergency room.	UNK	UNK	None	None	Prior hx of infantile febrile seizure and PCN allergy.  Pt otherwise healthy.			1						1	Grand mal convulsion; Presyncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89973~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB285AB~1~IM~RA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0345748	05/05/2009	GA	58.0	58		M		3 times Emergency Rooms. 6 days Hospital Stay. 6 days In House Rehab.  5/13/09 hospital records received DOS 12/4/08-12/9/08. FINAL DIAGNOSIS: Guillain Barre syndrome, hypertension, urinary retention, constipation, hyponatremia At time of vaccination c/o ear fullness and sinus pressure. Post vaccination tingling in hands feet back, facial numbness. Bells palsy. Diffuse pain and weakness right side of face. Nausea, vomiting. Lower extremity weakness. Dysphagia. Administration of IVIG. Discharge to rehab facility for PT, OT, speech therapy.  5/15/09 Received ER medical records of 11/26 & 11/30/2008. FINAL DX: Bell's Palsy 11/26/08 records reveal patient experienced sinus infection & tx w/oral antibiotic by PCP.  Developed weakness & numbness to left facial area & paresthesias of hands & feet.  Tx w/steroids, antivirals & patching.  Referred to PCP.  11/30/08  FINAL DX: neuropathies of UE & LEs Records reveal patient experienced increased & progressive stinging/burning pain & tingling of arms & legs & returned to ER twice this date.  His pain interferred w/sleep.  Tx w/pain meds w/good results & d/c to home on steroids & neurontin & referred to PCP.  7/1/09 Neurology consultant records received DOS 12/4/08 to 5/21/09. Assessment: Post infectious polyneuropathy/Guillain-Barre sundrome. Patient presents with bilateral facial weakness, tingling, and numbness of all 4 extremities, increasing weakness of lower extremities. Speech impaired. Reflexes absent. Diminished vibration sense. Difficulty walking. Cranial nerve 7 loss of function. Hyponatremia.			Y	Y	Y	12			N	11/05/2008	11/18/2008	13	5/13/09 hospital records received DOS 12/4/08-12/9/08. LABS and DIAGNOSTICS: LP - glucose 76 mg/dL (H), CSF protein 190 mg/dL (H), 38% lymphs, 62% monos, Cryptococcal antigen (-), RPR (-), Lyme serology (-), CSF cultures (-).   11/30/08 ER LABS: CT head WNL.  WBC 13,000, glucose 134.  EKG WNL.   IgG Synthesis Rate - CSF IGG Index 0.44 (WNL), IGG CSF 30.50 mg/dL (H), Albumin CSF mg/dL 107.00 (H), IGG ALB Ratio CSF 0.29 (H), IgG Synthesis 0.96 mg/24h, IgG antibodies serum 1990 mg/dL (H), Albumin serum 3100 mg/dL (L), IGG ALB ratio serum 0.6 (H)   CBC - WBC 13.4  K/uL (H), hemoglobin 13.4 g/dL (L), hematocrit 38.5% (L), platelets 354 K/uL (WNL). CHEM: sodium 128 mmol/L (L), potassium 3.6 mmol/L (WNL), chloride 95 mmol/L (L), CO2 26 mmol/L (WNL), BUN 16 mg/dL (WNL), creatinine 0.8 mg/dL (L), glucose 128 mg/dL (WNL), calcium 8.8 mg/dL (L), albumin 3.6 g/dL (WNL), AST 32 IU/L (WNL), ALT 61 IU/L (WNL), alkaline phosphatase 71 IU/L (WNL), total bili 0.9 mg/dL (WNL). Immunoelectrophoresis - IgA serum 446 mg/dL (H), albumin 3.85 g/dL (L), possible IgM Lamda protein.  Urinalysis - urobilinogen 4 (H), sodium 147 mmol/L (H), osmolality SR. 262 mosm/Kg (L).  Serial Spirometry with forced vital capacities. Nerve conduction studies.\  LABS and DIAGNOSTICS: WBC 13.4 (H), Sodium 128 (L), Sed Rate 29 (H). Other labs essentially normal. NCS - moderately severe sensory motor neuropathy of the demyelinating type affecting the left arm and leg.	PVT	OTH		Ear fullness, sinus pressure	High blood pressure  5/13/09 hospital records received DOS 12/4/08-12/9/08. PMH: hypertension, vitamin B12 deficiency. Shrimp allergy.  Kidney stones, knee surgery.			1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA185AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening,Hospitalisation	Influenza
0345823	05/06/2009	TX	46.0	46		M	05/06/2009	None stated									Y	05/06/2009				PVT	UNK						1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA389BA~2~UN~LL~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0345827	05/06/2009	OH	51.0	51		F		Went to ER on 4-29-09 c/o fever nausea and diarrhea and pain left arm - Followed up @ doctors office 4-30-09 and 5-6-09				Y					Y	04/28/2009	04/29/2009	1		PUB	PVT		None				1						1	Diarrhoea; Nausea; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U2768AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0554U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0345847	05/06/2009	RI	1.4	1	.4	F	05/06/2009	Fever 102-103, rash on face - dry cheeks. Vomited once resolved in 24 hour without further fever, rash on new symptoms.				Y					Y	03/31/2009	04/04/2009	4	None	PVT	PUB		None	None			1						1	Dry skin; Pyrexia; Rash; Vomiting	FLUX~SANOFI PASTEUR~UT279EA~2~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB329AA~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1470X~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0333635	05/07/2009	VA	43.0	43		F	05/05/2009	Initial information was received on 14 January 2009 from a health care professional. An unidentified patient received the Influenza virus vaccine on an unspecified date (trade name, manufacturer name, lot number, route and site not provided). After receiving the vaccine, the patient experienced an anaphylactic reaction. The date was not specified. Recovery status was not reported. When attempting to obtain further follow up, the reporter stated there was no adverse event to report, only questions pertaining to the vaccine and allergies. Follow-up information received on 27 April 2009 from a physician. It was unknown if this 43-year-old female patient had any concurrent illnesses at the time of vaccination, but it was reported she has medical conditions of allergic rhinitis, obesity and back pain; was taking concomitant medications of ZYRTEC, FLONASE and Levothyroxine (indication not reported) at the time of vaccination. The influenza vaccine was identified as FLUZONE SV 2008-2009 (lot number U2764AA); and it was administered intramuscularly on 25 November 2008 at 11:00 am. The site of administration was not reported. It was unknown how many previous doses of influenza vaccination the patient has received in the past. It was confirmed the patient experienced an anaphylactic reaction to the flu shot two hours post-vaccination on 25 November 2008 at 13:00 pm. Treatments received were not reported. The responsible physician's name and contact information was provided. The patient recovered (date not reported). Documents held by sender: None.				Y					Y	11/25/2008	11/25/2008	0	None	PVT	OTH	ZYRTEC; FLONASE; Levothyroxine		Not reported at time of report on 14 January 2009. From new information received on 27 April 2009, it was unknown if the patient had any concurrent illnesses at the time of the vaccination on 25 November 2008. the patient had medical conditions of allergic rhinitis; obesity; back pain, and was taking Levothyroxine (indication not reported) at the time of vaccination.		200900133	1						2	Anaphylactic reaction	FLU3~SANOFI PASTEUR~U2764A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0342483	05/07/2009	MT	21.0	21		F	05/07/2009	MD reports SM c/o paresthesia 24 hours after receipt of GARDASIL #2 (pt also got influenza vac 2/6/2009 but unknown which arm received which vac). Pt c/o inability to lift right arm for 1 month with full resolution of paresthesia (?duration?). Her pain fully resolved by 4/29/2009.				Y					Y	04/10/2007	02/06/2009	668	ESR; CRP order but pt did not have drawn. MRI right shoulder normal; X-rays normal	MIL	MIL	NSAIDS	Unknown	Unknown			1						2	Injected limb mobility decreased; Nuclear magnetic resonance imaging; Pain in extremity; Injected limb mobility decreased; Nuclear magnetic resonance imaging normal; Pain; Paraesthesia; X-ray normal	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPVX~UNKNOWN MANUFACTURER~~UNK~UN~UN~HPV (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~013349111A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~UNKNOWN MANUFACTURER~~UNK~IM~UN~HEP A (NO BRAND NAME)~2|HPV4~MERCK & CO. INC.~0188U~2~UN~UN~HPV (GARDASIL)~2	USA	Emergency room visit	Influenza
0345867	05/07/2009	NJ	70.0	70		F	05/03/2009	5 days after flu shot, I developed a rash.  This rash was all over my body except my face.  The dr's that treated me were dermatologist, family dr.,  Allergist, dermatologist. dermatopathology.  Report 11-20-08 reaction to flu vaccine (THIMEROSAL) Rash lasted 6 months									U	10/06/2008	10/11/2008	5	(Reaction to preservative in flu shot.  THIMEROSAL) Dermatopathology report log # 08: 044052 medical labs.  11-25-08	OTH	PUB	LUMIGAN (FLU GLAYCOMA)	None				1						1	Dermatologic examination abnormal; Rash generalised; Reaction to preservatives; Vaccination complication	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89882~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0345896	05/07/2009	IN	4.0	4		F	05/07/2009	Fell to floor after getting vaccines. Pt was pale and staring straight ahead with 2 shakes of head. RN was able to arouse pt and handed pt to father. After about 1min child became unresponsive, pale with cyanotic lips again. Turned head to right with 2-3 slight shakes. Episode lasted 3-4 seconds. Able to arouse again. No incontinence. No post ictal behavoir. Oriented to father. Ambulance arrived and transported pt to hospital.  HR 84 RR 32				Y					U	05/06/2009	05/06/2009	0	unknown	UNK	UNK	UNKNOWN	NONE	UNKNOWN			1						1	Cyanosis; Fall; Pallor; Posture abnormal; Staring; Tremor; Unresponsive to stimuli	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B062AA~5~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2831AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~A08362~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~1084X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1757X~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0345922	05/07/2009	WA	17.0	17		F	05/07/2009	Pt had vaccines (shots) for flu, polio, & yellow fever- She also started oral typhoid vaccine on 5/05/09.  She awoke 5/06/09 @ 6am with nausea by 9am was crying & shaking & felt tight in chest.  Returned home- We advised mom to take her to her doctor's office, Dr advised D/C oral typhoid.									Y	05/05/2009	05/06/2009	1		PUB	UNK		None	None			1						1	Chest discomfort; Crying; Nausea	FLU3~SANOFI PASTEUR~U2808AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~01060~UNK~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|TYP~BERNA BIOTECH, LTD.~300153U~1~PO~MO~TYPHOID LIVE ORAL TY21A (VIVOTIF)~1|YF~SANOFI PASTEUR~UF426AA~1~SC~RA~YELLOW FEVER (YF-VAX)~1	USA		Influenza
0345441	05/08/2009	WA	2.0	2	.0	F	05/08/2009	Within 12 hours of administration of vaccines, patient began vomiting every 30 minutes. The patient was transported to the ED.				Y					U	04/29/2009	04/29/2009	0	None	PVT	PUB						1						2	Vomiting; Vomiting	FLU3~SANOFI PASTEUR~UT2794~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB28LBB~2~IM~LL~HEP A (HAVRIX)~1|FLU3~SANOFI PASTEUR~UT2794EA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB281BB~2~IM~LL~HEP A (HAVRIX)~2	USA	Emergency room visit	Influenza
0345950	05/08/2009	FL	66.0	66		F	05/08/2009	On 3/12/09 Tetanus/Diptheria toxoid was given in the left arm along with influenza and pneumonia which were given in the right arm.  That night the patient complained of left arm swelling and not feeling well along with a fever.  On 3/16/09 pt has large area on left upper arm red,itchy, hot and swollen.  There is a 4inch bruised area around the injection site.  She no longer has a fever.									Y	03/12/2009	03/12/2009	0		UNK	UNK						1						1	Erythema; Feeling hot; Injection site haematoma; Malaise; Oedema peripheral; Pruritus; Pyrexia	FLU3~SANOFI PASTEUR~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|TTOX~SANOFI PASTEUR~U2332DA~UNK~IM~LA~TETANUS TOXOID (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~IM~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0345985	05/08/2009	PA	5.0	5		F	05/04/2009	Varicella vaccine breakthrough diagnosed by Dr in our office on 5-1-09. Had VARIVAX X 2. Sibling also has varicella.									U	10/24/2008	04/30/2009	188		PVT	PVT	No	No	None			1						1	Varicella post vaccine	FLUN3~MEDIMMUNE VACCINES, INC.~500567P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~0445X~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0345986	05/08/2009	PA	9.0	9		M	05/04/2009	Varicella Vaccine Breakthrough. Diagnosed in office by Dr. on 5-1-09. Had 30 lesions. VARIVAX X 2.									U	11/05/2008	04/29/2009	175		PVT	PVT	no	no	no			1						1	Varicella post vaccine	FLU3~SANOFI PASTEUR~2766AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1219X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0346098	05/11/2009	TX	32.0	32		M	05/08/2009	None Stated.										05/08/2009				UNK	UNK						1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA381AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0346157	05/12/2009	NC	38.0	38		F		None Stated										05/06/2009				UNK	UNK						1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88907~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0346175	05/12/2009	IL	0.5	0	.5	M	05/07/2009	Rash appeared 3 days after vaccine, with no associated signs or symptoms.  Rash consistent with erythema multiforme.  Coincided with day 7 of AMOXICILLIN for otitis media				Y					Y	04/30/2009	05/03/2009	3		PVT	UNK	AMOXICILLIN	Otitis media	None			1						1	Erythema multiforme; Rash	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B177CA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U2770AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~D21053~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~1472X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0346199	05/12/2009	WI	21.0	21		F	04/25/2009	Approx. 30 min after receiving 4 vaccines Pt became nauseous, felt feverish, arms felt like they were swelling.				Y					U	04/25/2009	04/25/2009	0		OTH	OTH	METAPHORMIN	None	ASA, PCN, Nuts & Almonds			1						1	Nausea; Oedema peripheral; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA192AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB697CA~1~IM~LA~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB302BA~1~IM~LA~HEP A (HAVRIX)~1|TD~SANOFI PASTEUR~U2346AA~UNK~IM~RA~TD ADSORBED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0346201	05/12/2009	NM	20.0	20		M	05/01/2009	C/O sore throat, difficulty swallowing, stiff neck am of 4/25; and R arm pain Sun am 4/26. Fever blister lip. Evaluated by Dr and started on NAPROSYN. T 99 5 x 4 red, raised, warm area, bell shaped on 4/28/09 @ 1400.									Y	04/24/2009	04/25/2009	1		OTH	PUB	None	None Known	None			1						1	Body temperature increased; Dysphagia; Musculoskeletal stiffness; Oral herpes; Oropharyngeal pain; Pain in extremity; Rash erythematous; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA356AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB584AA~1~IM~RA~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB252AA~1~IM~RA~HEP A (HAVRIX)~1|PPV~MERCK & CO. INC.~0551X~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~UF452BA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0346220	05/12/2009	AZ	4.0	4		M	05/12/2009	5-7-09 Crying, sore arms, couldn't move arms; temp 105 degrees F; mother gave Tylenol suppository; child projectile vomiting. Tylenol lowered fever but not completely. 5-8-09  Fever broke 1pm; couldn't move both arms; left arm swollen twice size of right arm; hot to touch.  5-9-09 Arms same, running nose.                 5-10-09  7am Difficulty breathing, increased heart rate; 1pm to ER; Diagnosis:  Bronchitis				Y					Y	05/06/2009	05/07/2009	1	n/a	PUB	PUB	none	none	normal seasonal allergies		AZ0904	1						1	Body temperature increased; Bronchitis; Crying; Dyspnoea; Heart rate increased; Injected limb mobility decreased; Oedema peripheral; Pain in extremity; Rhinorrhoea; Skin warm; Vomiting projectile	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B103BB~1~IM~LA~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~U2800DA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1507X~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0346241	05/12/2009	MN	77.0	77		F	05/11/2009	Pt walked into clinic at 10:00 am on 11-3-08.  She reported 4-5 hrs after getting vaccines pt noted redness, warmth, soreness and itching on upper left arm and pulse went to 1:15 & returned to normal w/5 min after doing valsalua movement - hx of evt.  The next day 11-1-08, the redness had spread to up her neck to the side of her face & was warm/itchy.  At night 11-1-09 pt had constant cough, phlegm production, wheezing when she layed down .  The redness is now decreased to 6 & 0 soreness and itching 0 cough.  Pt did not seek medical care with acute sx.									Y	10/31/2008	10/31/2008	0		PVT	PVT						1						1	Cough; Erythema; Heart rate increased; Increased upper airway secretion; Limb discomfort; Pruritus; Skin warm; Wheezing	FLU3~SANOFI PASTEUR~U2760AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0551X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0346257	05/13/2009	NC	24.0	24		F	05/12/2009	Information has been received from a pharmacist reported that a 25 year old female with no allergies received PNEUMOVAX (Lot# 662742/1117X), unknown dose, once, intravenously instead of intramuscularly (IM), a few minutes ago, on 31-JAN-2009 for vaccination. The patient's relevant medical history includes that she was post surgery; admission date was 31-JAN-2009. She had PERCOCET, so it was in her system and also had the influenza virus vaccine (manufacturer unknown) today 31-JAN-2009 before the PNEUMOVAX vaccine. The patient's relevant concomitant medications included COLACE, DILAUDID, CHROMAGEN CAPSULES, PHENERGAN, and TORADOL. The patient's relevant past drug history was unknown. On 31-JAN-2009, a nurse administered the PNEUMOVAX a few minutes ago IV instead of IM. The physician had been notified. It was unknown if any laboratory testing had been performed. As of 31-JAN-2009, it was unknown if the patient continued to take PNEUMOVAX vaccine and the pharmacist stated that she assumed that the patient was okay right now because she had not heard anything or gotten any orders for any medications and that the physician was monitoring the patient and was considering the Epipen. Follow-up information was received from the physician concerning the 24 year old female with no illness at time of vaccination, pre-existing allergies, birth defects or medical conditions. It was reported that there was no adverse event. The patient was observed in hospital for 12-24 hours after the event which prolonged hospitalization. No relevant diagnostic tests were performed. No further information is available.				Y			Y		U	01/31/2009	01/31/2009	0	Unknown	PUB	PUB	CHROMAGEN CAPSULES; COLACE; DILAUDID; TORADOL; PHENERGAN (PROMETHAZINE	Drug hypersensitivity; Hospitalisation	Surgery		WAES0902USA00071	1						1	Incorrect route of drug administration; No adverse event	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1117X~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0346317	05/14/2009	WI	57.0	57		F	04/27/2009	5-day(s) hospitalization for IVIG - extreme weight loss. Tripping, falling, loss of muscle mass, inability to walk without assistance. Now is in a wheelchair of which pain up feet legs, thigh persist. All of symptoms like respiratory breathing problems began in December of 2008. Had several doctor visits. 6/9/09 MR received for DOS 3/11-15/09 with DX: Guillain-Barre Syndrome- Acute Inflammatory Demyelinating Polyradiculopathy. Pt initially presented to pcp in 12/2008 with c/o low back and buttock pain and progressive weakness.  Initially thought to be a neuropathy (pt with DM typeII) however with increasing LE weakness pt referred to neuro. Admitted for IVIG. Recent 50 lb wt loss-unintentional. PE (+) for 0-4/5 strength of LEs, UEs WNL. absent-diminished reflexes in LEs. Sensory loss in LEs as well. Ataxic gait with bilateral foot drop. Follow-up: Unable to walk without assistance, except for small baby steps w/ assistance. Cannot go up stairs at all. Bowels shows incontinence, she still has extreme nerve pain - and has to have prescription drugs for pain, has to constantly fight a cold, she is also very sensitive to regular temperatures  gets too cold easy. Cannot stand more than 30 minutes. Has nerve pain in fingers, hands, legs, diaphragm. The atty that we picked from the list we were given from federal courts, has not made any strides - is there any other compensation for my mother's loss of ability to work full time, or even drive her (inability to) own car?				Y	Y	5			N	11/05/2008	12/15/2008	40	Lowered bilateral muscle tone, acute inflammatory and demyelinating polyradicular neuropathy and Guillain Barre-syndrome. Had EMG test, nerve conduction test 6/9/09-records received-Labs and diagnostics:  EMG/NCS (+) for polyneuropathy.  CSF protein 141. CSF glucose 82. CSF RBC (+) with nucleated cell count of 25.  Recent 50 lb wt loss-unintentional. PE (+) for 0-4/5 strength of LEs, UEs WNL. absent-diminished reflexes in LEs. Sensory loss in LEs as well. Ataxic gait with bilateral foot drop.  Labs and diagnostics:  EMG/NCS (+) for polyneuropathy.  CSF protein 141. CSF glucose 82. CSF RBC (+) with nucleated cell count of 25.  PMH:  DM type II, Diabetic neuropathy.  cataract extraction. pc  7/9/09 Neurologist labs received DOS 7/9/08 to 6/8/09. LABS: CHEM - Creatinine 0.4 mg/dL (L) Glucose 159 mg/dL (H) . CBC - WBC 10.1 k/uL (H) HGB 10.7 gm/dL (L) HCT 32.7% (L). CSF - Myelocyte 1% (H) Metamyelocyte 3% (H) Bands 14% (H) Segs 33% (H) Lymphocytes 28% (L) Macrophages 10% (L) Eosinophils 3% (H). Last seen doctor for up keep of therapy leg to help her strengthen muscles to walk	PUB	PUB	Diabetic medicine None	Diabetes II	Only diabetes 6/9/09-records received- PMH:  DM type II, Diabetic neuropathy.  cataract extraction.	~Influenza (Seasonal) (no brand name)~0~57.00~Patient		1						1	Abasia; Blood product transfusion; Fall; Gait disturbance; Hypotonia; Pain in extremity; Respiratory disorder; Weight decreased; Wheelchair user	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA357CA~1~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0346356	05/14/2009	NC	22.0	22		F	10/31/2008	22 y/o pregnant female, ADSM, reports receiving Flu Mist vaccine on 17 October 2008 despite being 38 weeks gestation. The service member decided to call the VHC for further information on the risks of the vaccine to her baby.									U	10/17/2008	10/17/2008	0	None	MIL	MIL	None	None	Normal pregnancy @ 38 weeks gestation Allergies: NKDA birth defects: None			1						1	Drug exposure during pregnancy	FLUN3~MEDIMMUNE VACCINES, INC.~500549P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0346359	05/14/2009	NC	45.0	45		M	11/10/2008	45 y/o  male, ADSM, is referred to the  Transition Unit for several day h/o nausea and vomiting associated with his receipt of Flu Mist vaccine on 28 Oct 08. Symptoms : Nausea w/ vomiting abdominal pain, Dizziness, joint pain, isolated.				Y					U	10/23/2008	10/29/2008	6	Normal CBC, Chemistry, Urinalysis, Pancreatic Functioning, and negative three way abdominal series X-Rays.	MIL	MIL	Nexium, Phenergan, Allegra, Fish oil capsules, Zocor, Naproxen, Rozerem, Meloxicam, Advair, Singulair, and Albuterol Inhaler.	None	No birth defects; No known drug, food, or medication allergies Medical conditions: Sleep APNEA, HTN, Hyper Cholesterolemia.			1						1	Abdominal pain; Arthralgia; Dizziness; Full blood count normal; Laboratory test normal; Nausea; Urine analysis normal; Vomiting; X-ray normal	FLUN3~MEDIMMUNE VACCINES, INC.~500549P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0346369	05/14/2009	WI	23.0	23		M	05/14/2009	0840- IM injection given - HEPA. HEPB & INFLUENZA given  0845 - Patient feeling weak, dizzy, chest tightness, HR60 blood pressure 60/40  0850 - Patient laid in trendelenbung position  08:53 - Blood pressure 90/70, patient given water, juice  0855 - Blood pressure 100/70									Y	05/14/2009	05/14/2009	0		MIL	UNK		No	Aspirin			1						1	Asthenia; Blood pressure decreased; Chest discomfort; Dizziness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA192AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB697CA~UNK~IM~RA~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB302BA~UNK~IM~RA~HEP A (HAVRIX)~1	USA		Influenza
0331828	05/15/2009	MD	65.0	65		F	05/15/2009	Ongoing severe generalized itching since October 26,2008.									U	10/24/2008				MIL	UNK	None	None	Pt reported allergy to Tylenol resulting in blurred vision.			1						2	Pruritus generalised	FLU3~SANOFI PASTEUR~0314911A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0343265	05/18/2009	AZ	18.0	18		F	05/14/2009	Information has been received form a physician assistant and a medical assistant concerning an 18 year old female with no pertinent medical history and no known drug allergies who on 27-MAR-2009 was vaccinated with the first dose of GARDASIL vaccine (lot# 661846/1312X). Concomitant therapy included influenza virus vaccine (unspecified) during same visit. On 27-MAR-2009, after vaccination, the patient fainted, fell from a seated position, hit a cabinet where she broke off half a tooth (tooth next to front teeth) and cut top of head on her barrette. A CT scan of the head was done at the diagnostic center down the hall from their office with normal results. According to the mother, the patient had been training for a marathon so had eaten that morning but had not had lunch. The event was not disabling or life threatening and did not require hospitalization. No sutures were needed for cut on top of head. The patient had recovered by the time she left the office. The patient remained in the office from approximately 1:30 PM to 4:00 PM on that day for observation. According to the mother in her follow-up phone conversation with the office on 30-MAR-2009, a dental veneer was required for the broke tooth. Additional information has been requested.				Y					Y	03/27/2009	03/27/2009	0	CT scan of the head, 03/27/09, normal	OTH	OTH			Unknown		WAES0904USA02812	1						2	Fall; Head injury; Immediate post-injection reaction; Loss of consciousness; Computerised tomogram normal; Fall; Head injury; Laceration; Syncope; Tooth injury; Body temperature increased; Computerised tomogram normal; Fall; Head injury; Immune system disorder; Mouth injury; Swelling face; Syncope; Tooth fracture; Tooth infection	FLU3~SANOFI PASTEUR~U2750AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1312X~3~UN~RA~HPV (GARDASIL)~1|FLUX~UNKNOWN MANUFACTURER~Unknown~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HPV4~MERCK & CO. INC.~1312X~1~UN~UN~HPV (GARDASIL)~2|FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|HPVX~UNKNOWN MANUFACTURER~~3~IM~LA~HPV (NO BRAND NAME)~3	USA	Emergency room visit	Influenza
0346462	05/18/2009	FL	0.6	0	.6	M	05/07/2009	Influenza vaccines rec'd 10/18/07 and 11/20/07. 3 mos later developed Guillain-Barre syndrome/was hospitalizsed for acute lower extr. weakness.  5/19/09 hospital records received DOS 2/13/08 to 2/18/08. FINAL DIAGNOSIS: Acute lower limb weakness, possible Guillain-Barre Syndrome. Post vaccination: Choking episode, weakness and inability to bear weight on lower limbs. Fails to sit up or crawl. Otitis media. Decreased tone and power lower limbs. Biceps/triceps reflexes weak. Absent patellar reflexes. Weak ankle reflexes. Tachypnea, limp 3 doses of intravenous immunoglobulin.  7/7/09 Medical records received DOS 11/20/07 to 3/30/09. Assessment: Acute infective polyneuritis, Guillain-Barre syndrome. Patient presented with absent knee, achilles reflexes and absent superficial reflexes of feet. No rolling, no tactile sensation back. No weight bearing on legs, falls forward when sitting. Keeps legs extended, scissoring. Gradual improvement of neurological findings. Left side of gluteal fold 2 inch erythematous ring surounding pustule.				Y	Y	5			Y	11/20/2007	02/05/2008	77	MRI Brain/Spine, EEG NL  5/19/09 hospital records received DOS 2/13/08 to 2/18/08. LABS and DIAGNOSTICS: CT head, cervical, thoracic, lumbar spine normal. CSF - WNL. EEG normal.	PVT	PUB	5/19/09 hospital records received DOS 2/13/08 to 2/18/08. Amoxicillin	PARONYCHIA & CERUMEN IMP	Developmental D/O-Hearing; ?'s 2 mos-screen passed; No crawl/pincer @ 9 mos 7/7/09 Medical records received DOS 11/20/07 to 3/30/09. Abscess finger. I&D.			1						1	Electroencephalogram normal; Guillain-Barre syndrome; Muscular weakness; Nuclear magnetic resonance imaging brain normal; Nuclear magnetic resonance imaging normal	DTAP~SANOFI PASTEUR~C2606AA~3~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT2474AA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~00146R~3~IM~LL~HEP B (FOREIGN)~1|PNC~PFIZER\WYETH~B47300H~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~08774~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0346508	05/18/2009	GA		0	.0	M	05/18/2009	This case was reported by a pharmacist and described the occurrence of decreased oxygen saturation in a neonate male subject who was inadvertently vaccinated with FLUARIX (GlaxoSmithKline). There were no concomitant medications or relevant medical history. On 6 April 2009 the subject accidentally received a dose of FLUARIX (0.5 ml, unknown site) instead of ENGERIX B; wrong vaccine administered and maladministration (asymptomatic/child too young). On 7 April 2009, 1 day after vaccination with FLUARIX, the subject experienced decreased oxygen saturation. The subject was transferred to the Neonatal Intensive Care Unit, prolonging hospitalization. He was discharged on an unspecified date. On 8 April 2009, the events were resolved. The reporting pharmacist considered the maladministration occurred due to the ENGERIX B and FLUARIX syringes resemblance and small print. The pharmacist also stated that FLUARIX had been stocked in the ENGERIX B holder in the refrigerator in labor and delivery. The pharmacist intended to complete a report.					Y	0			Y	04/06/2009	04/06/2009	0	UNK	PVT	PUB		Unknown	There were no concomitant medications or relevant medical history.		A0784617A	1						1	Drug administration error; Intensive care; Oxygen saturation decreased; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0346512	05/18/2009	VA	23.0	23		U	05/18/2009	Pt had AVA and Influenza shot on 4/14/09 and SPV 4/16/09.  She returned to the Imm Clinic on 4/23/09 for evaluation of SPV (major take); pt requested a pg test which was positive (LMP 3/16/09).  Pt indicated that she was not pg on the SPV questionnaire.  Symptoms:  Amenorrhea.										04/14/2009	04/23/2009	9	Pregnancy Test Qual 23 Apr 2009 1038; hCG SERUM POSITIVE (H); Chlamydia + Gonococcus DNA Panel NAAT 05 May 2009 2045 Chlamydia trachomatis DNA ENDOCERVIX CONFIRMED POSITIVE (H) Neisseria gonorrhoeae DNA ENDOCERVIX NEGATIVE	OTH	UNK	None	None	None			1						1	Amenorrhoea; Blood human chorionic gonadotropin positive; Chlamydia identification test positive; Drug exposure during pregnancy	ANTH~EMERGENT BIOSOLUTIONS~FAV113~UNK~UN~LA~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U2831AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0346521	05/18/2009	NC	30.0	30		F		None stated										05/11/2009				UNK	UNK						1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88907~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0346537	05/18/2009	LA	45.0	45		F	05/06/2009	Patient came in for Flu vaccine, Right and TDAP, Left. Complaint of pain and swelling next day- c/o very painful. Called PMD today-appointment made for 5/7/09 at 8:30/AM.										05/01/2009	05/02/2009	1		PVT	PUB		None	None		LA090503	1						1	Pain; Swelling	FLU3~SANOFI PASTEUR~U2848AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C3057AA~1~UN~LA~TDAP (ADACEL)~1	USA		Influenza
0346552	05/18/2009	MI	21.0			M	05/13/2009	None Stated														UNK	UNK	TB; Pharmceticals; 84835; Neg; 0.1 mL					1						1	Unevaluable event	FLUX~UNKNOWN MANUFACTURER~AFLLA156AA~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB132AC~UNK~UN~UN~HEP A + HEP B (TWINRIX)~1	USA		Influenza
0346903	05/18/2009		14.0	14		F	05/14/2009	Information has been received from a Allergy Technician concerning a 14 year old female patient with no pertinent medical history and no drug reactions or allergies who on 14-NOV-2008 was vaccinated with a first dose of GARDASIL (Lot # 656049/0187U) 0.5ml, intramuscularly. Concomitant therapy included influenza virus vaccine (unspecified). On approximately 05-DEC-2008 the patient experienced fatigue and headaches. The patient was a basketball player and she could not participate in some recent drills. The patient had a schedule appointment to see a cardiologist on 06-MAY-2009. On 09-JAN-2009 the following diagnostics laboratory test were performed: Completed blood cell count (CBC), blood hemoglobin test (HGB): 11.7 was low, Lymphatic percentage: 47.2 was high and lymphatic number: 3.2 was high. At the time on the report on 17-APR-2009 the patient had not recovered. The patient sought medical attention was at office. Additional information has been requested.				Y					N	11/14/2008	12/05/2008	21	diagnostic laboratory, 01/09/09, 3.2, Lymphatic number. Was High; diagnostic laboratory, 01/09/09, 47.2%, Lymphatic percentage. Was High; hemoglobin, 01/09/09, 11.7, low; complete blood cell, 01/09/09, result not showed	OTH	OTH			None		WAES0904USA02916	1						1	Activities of daily living impaired; Fatigue; Full blood count; Haemoglobin decreased; Headache; Lymphocyte count increased; Lymphocyte percentage increased	FLU3~SANOFI PASTEUR~U2791DA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0187U~1~IM~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0342045	05/19/2009		13.0			F	05/18/2009	This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old very healthy and athletic female patient, allergic to the fruit formula given before having a CAT scan, was vaccinated in the left arm with the first dose of GARDASIL (Lot # 659435/1265U). Concomitantly, the first dose of influenza virus vaccine (unspecified) (manufacturer unknown) (Lot # 500487P) was given. It was reported that the patient experienced fever, severe abdominal pain and muscle aches. The patient was lethargic and had asthma. The patient also developed skin indentations (tissue break down up underneath the skin). The indentations were circular in size, starting around the injection site and had spread throughout entire body. A specialist stated that had never seen anything like it. The patient was referred for further testing. The indentations were not going away but permanently scarring the patient. The patient was also experiencing vertigo. Records received on 23-MAR-2009 from date of Service of 10-NOV-2008 presented a patient complaining of lesions to trunk and extremities. Records received on 30-MAR-2009 from Emergency Department visit on 02-NOV-2008 showed a patient complaining of abdominal pain and a diagnosis of ruptured ovarian cyst. Doctor's office records showed two other shots of Td adult vaccine given on 17-OCT-2008 (Lot # C2778AP) and also MONOTZ (Lot # U2426AA) given on 18-OCT-2007. Several biopsies were performed by two dermatologist (specialist) and regular dermatologist with unreported results. The patient did several regular doctor visits. An ultrasound and CAT scan of abdomen-biopsy were performed, which records were received on 23-MAR-2009, with unreported results. The listing indicated that one or more of the events required hospitalization. No further information is available. The original reporting source was not provided. The VAERS ID # 342045. Follow up information was received on 01-MAY-2009 via a senator's office, from a constituent who is the patient's mother. The reporter stated that the patient received GARDASIL , nasal flu, meningitis and tetanus shot all on the same day, and now has asthma, skin tissue (fibers breaking down) in a pox like formation, sweating, hospitalized for severe abdominal pain, fever, and more symptoms. The reporter noted that GARDASIL has not been tested with the nasal flu, meningitis, or tetanus shots, and that the most severe side effects occur when you combine it with the meningitis shot. The patient's mother stated that her daughter had over seventy pox like formations on her body, scarring her body and never going away. The patient had skin biopsies taken (results not reported). The patient has been reviewed by several dermatologist specialists and all of the doctors have never seen anything like this. She was also taken to see an immunologist and rheumatologist and they've never seen this before. Her case is currently being reviewed by a vaccine side effect specialist. No further information is available. This report was filed with the FDA. The ISR number is 342045.				Y	Y				N	10/18/2007	10/18/2007	0	Unknown	OTH	OTH	Unknown	Contrast media allergy			WAES0904USA01472	1						2	Abdominal pain; Asthma; Biopsy skin; Computerised tomogram; Lethargy; Myalgia; Pyrexia; Scar; Skin disorder; Ultrasound abdomen; Vertigo; Abdominal pain; Asthma; Biopsy skin; Computerised tomogram; Hyperhidrosis; Lethargy; Myalgia; Ovarian cyst ruptured; Pyrexia; Scar; Skin disorder; Skin lesion; Vertigo	FLUN3~MEDIMMUNE VACCINES, INC.~500487P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~1265U~1~IM~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2426AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C2775AA~1~IM~RA~TDAP (ADACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500487P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|HPV4~MERCK & CO. INC.~1265U~1~UN~LA~HPV (GARDASIL)~2|MEN~UNKNOWN MANUFACTURER~~UNK~UN~UN~MENINGOCOCCAL (NO BRAND NAME)~2|TD~SANOFI PASTEUR~C2778AP~UNK~UN~UN~TD ADSORBED (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0346569	05/19/2009	CA	52.0	52		F	05/18/2009	Information has been received from a 52 year old licensed visiting nurse who was splashed while she was withdrawing a dose of PNEUMOVAX 23 in approximately September 2008 (fall of 2008). Concomitant therapy included hydrochlorothiazide and WELLBUTRIN. In November 2008, the patient experienced bronchitis, shortness of breath and sinus infections. The patient was tested for Valley fever and had a chest x-ray performed (results not reported). The patient was seen by her physician. The outcome was not recovered. Follow-up information has been received from a licensed visiting nurse with a history of sinusitis concerning her experienced while giving residents immunizations at a skilled nursing facility. On approximately 01-NOV-2008 the nurse was drawing up either the PNEUMOVAX 23 or influenza vaccine (NOVARTIS) and small amount of vaccine escaped from the needle/vial as she withdrew the needle. This surprised her and she gasped at the same moment and inhaled either flu vaccine (NOVARTIS) or PNEUMOVAX 23. The nurse stated she only remembered this a week or so after the fact, when on 02-NOV-2008 she ended up in the ER with shortness of breath, unable to catch her breath shorting after the incident. On an unknown date a chest X ray was done and was clear. Ever since the patient has been wheezing, coughing and with shortness of breath and have not recovered. The nurse considered that the events resulted in persistent or significant disability. Additional information has been requested.				Y				Y	N	11/01/2008	11/01/2008	0	diagnostic laboratory, valley fever; chest X-ray, clear	OTH	OTH	WELLBUTRIN; hydrochlorothiazide	Sinusitis			WAES0904USA00481	1						1	Accidental exposure; Bronchitis; Chest X-ray normal; Condition aggravated; Cough; Dyspnoea; Laboratory test; Sinusitis; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0346570	05/19/2009	MT	69.0			F	05/18/2009	Information has been received from a 69 year old female patient who 2 or 3 years ago was vaccinated with a dose of PNEUMOVAX (manufacturer unknown). Secondary suspect vaccine given on the same day included influenza virus vaccine (unspecified). It was reported that 2 or 3 years ago the patient experienced an allergic reaction like swelling after receiving PNEUMOVAX and influenza virus vaccine together and was hospitalized for couple days. It was reported that the patient had recovered on an unspecified date. Additional information has been requested.				Y	Y	0			Y				Unknown	OTH	OTH	Unknown		Unknown		WAES0905USA01285	1						1	Hypersensitivity; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0346653	05/19/2009	NC	35.0	35		M		None stated										05/13/2009				UNK	UNK						1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88907~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB437CA~UNK~UN~LA~HEP B (ENGERIX-B)~1	USA		Influenza
0346726	05/20/2009	SD	1.5	1	.5	M	05/20/2009	Mother reported that child's entire left thigh was reddened, swollen, and warm to touch within 25 hours of receipt of vaccines. Mom gave motrin and benadryl for 2 days at which time the condition resolved. Child was not irritable, feverish, or limited in activity level.									Y	04/22/2009	04/23/2009	1	none	PUB	PUB	none	none	none			1						1	Injection site erythema; Injection site swelling; Injection site warmth	DTAP~SANOFI PASTEUR~U2291BA~4~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT2782EA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB234BA~1~IM~RL~HEP A (HAVRIX)~1	USA		Influenza
0346730	05/20/2009	CA	59.0	59		M	05/20/2009	Within a few months of the vaccination on 12/05/06, I became less stable on my feet, and experienced symptoms of neuropathy including foot drop, loss of muscle strength, loss of reflexes, muscle loss, problems with gait, pain and numbness in feet, and now numbness in hands.  I did not seek medical attention immediately, and, at first, attributed symptoms to old age or low back condition.  I eventually saw my family physician in 8/07 to discuss my symptoms which were continuing to get worse.  In 10/08, I was diagnosed with very severe and very chronic neuropathic disease.  Medical records received 10/4/08 to 10/17/08. Assessment: Progessive weakness of lower extremities and foot drop on the right. Patient presents with numbness, muscle spasm, weakness in legs. Paresthesias and muscle wasting from knees to feet. Dorsiflexor weakness right greated that left. Unable to elevate great toe. Weight loss. Follow-up: Loss of feeling, muscle strength in my hands and feet - nearly disabled, and getting worse as the months go on. Walking now with leg braces.								Y	N	12/05/2006	04/15/2007	131	On observation, I have disturbing gait abnormalities with difficulty with heel and toe walking.  Received an MRI on 11/29/07 - results normal.  Neurologist tested in office and found that I am ataxic on performing tandem gait test, and great difficulty walking on heels.  Romberg test was very unsteady.  Dr. administered an Electrodiagnostic evaluation (EMG) in October, 2008, because I am experiencing numbness and tingling in feet, and feels like socks are bunched up under feet.  My legs feel generally weak, and I trip and stumble.  Also experience cramping in hands and feet, and stiffness in hands.  Test results show very severe and very chronic neuropathic disease compatible with myotonic muscular dystrophy.  Genetic testing in November, 2008 show negative for muscular dystrophy.  Muscle biopsy pending.  Further testing in April, 2009 result in diagnosis of neuropathy.  Further testing scheduled for October, 2009 to determine what kind of neuropathy I have. Medical records received 10/4/08 to 10/17/08. LABS and DIAGNOSTICS: B12 Level WNL. Folate Level WNL. Nerve Conduction Studies - suggestive of muscular dystrophy.	UNK	UNK	skelaxin, nexium, lunesta, arthrotec, metroprolol, cyclobenzaprine, arthrotec, flexeril, methocarbomol, omeprazole	none	nausea when taking codeine related medications	none~ ()~~0.00~Patient|none~ ()~~0.00~Sibling		1						1	Areflexia; Asthenia; Ataxia; Biopsy muscle; Blood folate normal; Electromyogram; Gait disturbance; Gait disturbance; Hypoaesthesia; Muscle atrophy; Muscle spasms; Muscular dystrophy; Muscular weakness; Muscular weakness; Musculoskeletal stiffness; Neuropathy peripheral; Nuclear magnetic resonance imaging normal; Orthosis user; Pain in extremity; Peroneal nerve palsy; Positive Rombergism; Tandem gait test abnormal; Vitamin B12 normal; Weight decreased	FLUX~SANOFI PASTEUR~U2251AA~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Disabling	Influenza
0328370	05/21/2009	IL	12.0	12		M	05/15/2009	Information has been received from a physician concerning a 12 year old male who on 13-OCT-2008 was vaccinated with a second dose of VARIVAX (Merck) (lot #661653/1140X) SC into the right arm, a dose  of ADACEL (lot # C2767AA) IM into the right deltoid, a first dose of MENACTRA (lot # U2618AA) IM into the left deltoid and a second dose of FLUMIST (lot #500545P) via nasal route. The vaccines were given as instructed by the physician, followed by lead test (capillary phlebotomy) at the patient's mom's request. After lead test completed and bandaid applied, the patient complained of dizziness, light headedness and nausea. The episode resolved approximately 30-45 seconds after an emesis. Laboratory data and diagnostic test included pulse oximetry (POX) at 98% and heart rate (HR) at 78. No further information is available.									Y	10/13/2008	10/13/2008	0	pulse oximetry, 98%; total heartbeat count, 78 bpm	PVT	PVT			Unknown		WAES0810USA02389	1						2	Dizziness; Heart rate normal; Nausea; Oxygen saturation normal; Vomiting; Dizziness; Heart rate normal; Nausea; Oxygen saturation normal; Vomiting; Dizziness; Nausea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500545P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|MNQ~SANOFI PASTEUR~U2618AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TDAP~SANOFI PASTEUR~C2767AA~UNK~IM~RA~TDAP (ADACEL)~2|VARCEL~MERCK & CO. INC.~1140X~2~SC~RA~VARICELLA (VARIVAX)~2|FLUN3~MEDIMMUNE VACCINES, INC.~500545P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3|MNQ~SANOFI PASTEUR~U2618A~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~3|TDAP~SANOFI PASTEUR~C2767A~1~IM~RA~TDAP (ADACEL)~3|VARCEL~MERCK & CO. INC.~1140X~2~SC~UN~VARICELLA (VARIVAX)~3|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~5|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~5|MNQ~SANOFI PASTEUR~~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~5|TDAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~TDAP (NO BRAND NAME)~5	USA		Influenza
0347097	05/21/2009	CA	1.0	1	.0	M	05/15/2009	Information has been received from a physician concerning a 18 month old male who on 08-OCT-2007 was vaccinated in right arm subcutaneously with a dose of VARIVAX (Merck, lot #658378/1122U). Concomitant therapy included an unspecified influenza shot received at the same time of VARIVAX. The physician said that VARIVAX was a vaccine failure: Physician states that the patient's parents mentioned that the child had a rash since 23-APR-2008. The rash was getting better as of the report date. Upon inspection, the physician thought it looked like simple dermatitis; however, it was unilateral but in unilateral dermatome across the chest which lead the physician to believe that the patient experienced shingles. The patient had not been clinically exposed to chicken pox that the physician knew of but he felt that the patient must had been exposed unknowingly and had a subclinical case. Additional information has been requested.									N	10/08/2007	04/23/2008	198	Unknown	OTH	OTH			None		WAES0805USA01387	1						1	Herpes zoster; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~1122U~UNK~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0347159	05/21/2009	NY	1.19	1	.2	F	05/15/2009	Information has been received from a consumer concerning her almost 15 month old daughter with no known medical history who on 05-FEB-2009 was vaccinated with a dose of VARIVAX (Merck).  Concomitant therapy included vitamins (unspecified).  The consumer stated that a few days post vaccination the patient developed a reaction at the injection site of her right arm; there was a small pin prick at the site.  Then a few days later this developed into a bigger, red, swollen area.  She also had a few faint red marks on her face.  The physician was not able to tell if the marks on her face were chickenpox.  The patient sought medical attention went to the office.  At the time of reporting the patient had not recovered.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/15/2009. Follow up information was received from a physician. It was reported that on 05-FEB-2009, the patient with good general health was vaccinated with a first dose of VARIVAX (Merck) (Lot # 661969/1392X) in the right arm and with a second dose of FLUZONE, Lot # UT2783DA) into the right leg. On 14-FEB-2009, the patient had a welt on the right upper arm, there was no vessicle. The welt resolved quickly. There were no labs/diagnostics performed. Additional information is not expected.				Y					N	02/05/2009	02/14/2009	9	None	PVT	PVT	Vitamins (unspecified)		None		WAES0902USA03138	1						1	Injection site erythema; Injection site swelling; Rash erythematous	FLU3~SANOFI PASTEUR~UT2783DA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1392X~2~UN~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0347253	05/21/2009	MI	8.0			F	05/15/2009	Information has been received from a registered nurse concerning an 8 year old female who on an unspecified date was vaccinated with a second of VARIVAX (Oka/Merck) (lot# 66164/0974X). Concomitant therapy included a dose of influenza virus vaccine (unspecified). Twelve days after the vaccination the patient developed a varicella reaction at the injection site. The varicella reaction was described as localized at the injection site, painful and pox like. Subsequently, the patient recovered from the varicella reaction. This is one of several reports from the same source. Additional information has been requested.									Y				Unknown	OTH	OTH			Unknown		WAES0890USA02671	1						1	Injection site pain; Injection site reaction; Injection site vesicles	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~0974X~2~UN~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0347293	05/21/2009	TX	1.2	1	.2	F	05/15/2009	Information has been received from a physician concerning a 14 month old female with no drug allergies or reactions a history of reactive airways and frequent rhinitis who on 17-OCT-2008 was vaccinated with the first dose of VARIVAX (Merck). Concomitant therapy included MMR II (dose not reported). Other concomitant medication on that same date included Influenza virus vaccine (manufacturer unspecified). On 18-OCT-2008 the patient developed a low-grade fever, one day after receiving her first dose of MMR II and VARIVAX (Merck) on 17-OCT-2008. On 22-OCT-2008 the patient developed a high fever, vomiting, muscle twitches and a febrile seizure. On 22-OCT-2008 the patient was seen in the office that day, a complete blood count, urinalysis, sed rate, C-reactive protein and chest x-ray were negative. On 24-OCT-2008, the patient's mother sought a second-opinion in a local emergency room. The physician relays a completed workup of unspecified tests in the emergency room were negative. On 25-OCT-2008, the patient became afebrile. On 30-Oct-2008 the patient was seen in the office again because of a decrease in hand-eye coordination and episodes of vacant staring. It is not known if these episodes are seizure. The physician is ordering an electroencephalogram and, possibly, a neurological consult. On 30-OCT-2008 the physician reported that patient was not recovered from febrile seizure, decrease in hand-eye coordination, muscle twitches, vacant staring and vomiting. No further information is available. Upon internal review febrile seizure was considered as an other important medical events. Additional information has been requested.									N	10/17/2008	10/18/2008	1	Chest X-ray, 10/22/08, negative; Diagnostic laboratory, 10/22/08, negative; Complete blood cell, 10/22/08, negative; Urinalysis, 10/22/08, negative; erythrocyte, 10/22/08, negative; Serum C-reactive protein, 10/22/08, negative	OTH	OTH			Reactive airways disease; Rhinitis		WAES0810USA05270	1						1	C-reactive protein normal; Chest X-ray normal; Coordination abnormal; Febrile convulsion; Full blood count normal; Laboratory test normal; Muscle twitching; Pyrexia; Red blood cell sedimentation rate normal; Staring; Urine analysis normal; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~1~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~~1~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0347304	05/21/2009	WI	1.5	1	.5	M	05/15/2009	Information has been received from a physician concerning a male with positive skin test for egg and soy (physician stated not a clinical allergy to soy) and a history of cleft palate syndrome who on 29-Nov-2006 was vaccinated his first dose of VARIVAX (Oka/Mereck) at the primary health care provider's office. Suspect vaccination administered on that same day included a dose of influenza virus vaccine (unspecified). Post vaccination the patient had an anaphylactic reaction, was treated and monitored and was not hospitalized. Subsequently the patient recovered . On 21-May-2008 at 3 years of age, the patient was vaccinated with his second dose of VARIVAX (Oka/Mereck) at the same primary care provider's office and other vaccines. At 15 minutes post-vaccination, the patient experienced a second occurrence of anaphylactic reaction in the parking lot and was taken back into the doctor's office, treated and taken by ambulance to the hospital. The child was hospitalized for 24 hours and treated with epinephrine, anti-histamines and oral steroids. The child had a follow-up visit with the physician. Subsequently, the patient fully recovered. Follow-up information has been received from a physician concerning an 18 month old male patient who's initial initial episode of anaphylaxis occurred on 29-Nov-2006. During that visit, he had also received PEDIARIX, (Oka/Merck) and influenza vaccine. This was his primary immunization to the VARIVAX (Oka/Merck). He went to develop fitful sneezing, copious rhinorrhea, facial and periorbital edema. He was treated with epinephrine and Benadryl and cleared promptly. He subsequently was skin test positive to egg but had not been skin tested to the individual vaccines. On 21-May-2008 the patient received the second dose of VARIVAX (Oka/Merck). He went on to develop a similar but more severe reaction with copious rhinorrhea, fitful sneezing, generalized urticaria, wheezing and labored breathing. The patient was treated with epinephrine and Benadryl and was transported via 911 to a local emergency room. There he went to develop a late-phase reaction with recurrence of similar symptoms but also had some hypotension with systolic blood dropping into the 50s. The patient received additional emergency care, IV fluids, and recovered with no sequela. Anaphylactic reaction was considered to be immediately life-threatening and another important medical event by the physician. Additional information has been requested.			Y	Y	Y	1			Y	11/29/2006	11/29/2006	0	Allergen Skin test, positive to eggs; Blood pressure, 50s	OTH	OTH	Unknown	Egg allergy	Cleft palate		WAES0806USA07544	1						1	Anaphylactic reaction; Blood pressure systolic decreased; Dyspnoea; Face oedema; Hypotension; Periorbital oedema; Rhinorrhoea; Skin test positive; Sneezing; Urticaria; Vaccine positive rechallenge; Wheezing	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~DTAP + HEPB + IPV (PEDIARIX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~~1~UN~UN~VARICELLA (VARIVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0347318	05/21/2009	AL	9.0	9		F	05/15/2009	Information has been received from a physician concerning a 9 year old female who on 09-JUL-1999 was vaccinated with a first dose of VARIVAX (Oka/Merck). At 10:30am 18-OCT-2007, the patient was vaccinated in the right arm with a second dose of VARIVAX (lot # 656287/1508F) with diluent (lot # 3013U). Concomitant therapy included FLUZONE which was vaccinated in the left arm at the same time. On 19-OCT-2007, the patient experienced erythema measuring 4.5 cm in diameter and pain at the injection site of VARIVAX (Oka/Merck) on the right arm, and mild edema was also noted. The physician was contacted. On an unspecified date the patient was treated with cold compresses and BENADRYL for itch if any. On 22-OCT-2007, the patient recovered. This is one of several reports from the same source. No further information was available.				Y					Y	10/18/2007	10/19/2007	1	Unknown	PVT	PVT			Unknown		WAES0810USA02135	1						1	Injection site erythema; Injection site oedema; Injection site pain	FLU3~SANOFI PASTEUR~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1508F~2~UN~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0347329	05/21/2009	PA	1.3	1	.3	M	05/15/2009	Initial and follow-up Information has been received from a nurse practitioner, concerning a 15-month-old male infant with eczema, who on 20-OCT-2008 received the first dose of 0.5 ml VARIVAX (Merck) (lot # 661661/0995X) via subcutaneous route on his right leg. Concomitant vaccinations included the fourth dose of PREVNAR (lot # C68312) IM in the left leg, the first dose of HAVRIX (lot # B257AA) IM in the right leg, and the first dose of FLUZONE (lot # UT2787AA) IM in the left leg. On 30-OCT-2008 (previously reported as 29-OCT-2008), 10 days post vaccination, the patient presented at office with 3 reddish yellow vesicles on his leg around the injection site. His mother was advised to give him BENADRYL PRN. At the time of reporting, the patient's outcome was unknown. Additional information is not expected.				Y					U	10/20/2008	10/30/2008	10	None	OTH	OTH		Eczema			WAES0810USA05259	1						1	Injection site vesicles	FLU3~SANOFI PASTEUR~UT2787AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~B257AA~1~IM~RL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~C68312~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0995X~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0347353	05/21/2009	MA	16.0	16		M	05/15/2009	Information has been received from a physician concerning a 16 year old male with no pertinent medical history who on 03-JUN-1998 was vaccinated with a first dose of VARIVAX subcutaneously.  On 03-NOV-2008 was vaccinated with a second dose of VARIVAX (Merck) (lot # 661856/1222X) 0.5 mL, subcutaneously.  There was no concomitant medication.  On 04-NOV-2008 the patient experienced an injection site reaction.  The patient experienced a rash that was itchy, red, swollen, and warm to the touch.  At time of reporting, the patient was recovering.  The patient sought medical attention and saw the physician.  In follow-up information, the physician reported that on 03-NOV-2008 the patient received a dose of FLUZONE IM (lot # 02769AA).  The physician reported that the patient's adverse events occurred on his right arm.  The patient recovered on 07-NOV-2008.  The patient had no illness at time of vaccination.  The patient also had an adverse reaction after vaccination with hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) (WAES # 0812USA00480).  No further information is available.				Y					Y	11/03/2008	11/04/2008	1	Unknown	PVT	PVT			None	Allergy to vaccine~Hep B (no brand name)~UN~16.00~Sibling	WAES0811USA00949	1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~02769AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~1222X~2~SC~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0347356	05/21/2009		7.0	7		F	05/15/2009	Information has been received concerning a 7 year old female with no concurrent conditions or pertinent medical history who on 28-OCT-2008 received a booster of VARIVAX vaccine (Oka/Merck). Concomitant therapy included influenza virus vaccine (unspecified) and hepatitis A virus vaccine (unspecified). On 31-OCT-2008 was noticed 5-6 pustular lesions on chest. On 03-NOV-2008 through 05-NOV-2008 noticed increasing maculopapular rash on chest and some small areas on back. One lesion upper arm. Nothing on face, neck, legs. No fever or any other complaints. Rash itchy, but no painful. The patient sought medical attention. On 5-NOV-2008 the primary pediatrician felt that it was not varicella, possibly shingles- although it crossed dermatomes. The patient was referred to a dermatologist. On 06-NOV-2008 the first dermatologist felt it was shingles, although when another dermatologist was consulted at the same appointment, the patient was diagnosed with poison ivy. The outcome of the patient was not reported. Follow up information was received from the medical assistant who stated that the patient did not have an adverse effect from VARIVAX (Merck). It was determined that the patient had poison ivy. Additional information has been requested.									U	10/28/2008	10/31/2008	3	Unknown	OTH	OTH		Unknown	Unknown		WAES0811USA00986	1						1	Dermatitis contact; Rash maculo-papular; Rash pruritic; Rash pustular	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~MERCK & CO. INC.~~UNK~UN~UN~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~~2~UN~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0347366	05/21/2009	TX	1.0			F	05/15/2009	Information has been received from a physician concerning her 12 month old daughter who on an unspecified date was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Oka/Merck).  Secondary suspect therapy included MMR II (Wistar RA 27/3).  Other concomitant therapy included flu and DTAP.  It was reported that within one week of receiving VARIVAX (Oka/Merck), the patient developed a mild rash but was not fussy.  The patient sought physician's medical attention.  Subsequently, on an unspecified date, the patient recovered.  The physician's older daughter developed an adverse experience after receiving a dose of VARIVAX (Oka/Merck) (WAES 0811USA02274).  Additional information has been requested.									Y				Unknown	OTH	OTH			Unknown	Chickenpox~Varicella (no brand name)~UN~2.70~Sibling	WAES0811USA02164	1						1	Rash	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~~UNK~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0347367	05/21/2009	CA	1.1	1	.1	F	05/15/2009	Information has been received from a registered nurse (RN) concerning a 13 month old female with eczema who on 31-Oct-2008 was vaccinated subcutaneously in the left triceps with a 0.5ml dose of VARIVAX (Oka/Merck) (Lot#661649/1156X). Concomitant therapy included acetaminophen (Tylenol). On 10-Nov-2008 the patient developed a red nodule at injection site that was warm to touch. On 13-Nov-2008 the patient had an office visit and was examined by physician. On that day the patient had a non-tender by 1 cm erythematous patch with a 1cm induration at the injection site. The patient was treated with Hydrocortisone cream. At the time of the report, 13-Nov-2008, the patient had not recovered from the events. Follow-up information was received from the R.N. on 08-Jan-2009 concerning a 13 month old white female with eczema. On 31-Oct-2008, at 9:00 a.m. the patient was vaccinated subcutaneously in the left tricep with a first dose of VARIVAX (Oka/Merck)  (Lot#561649/1156X). On the same day, at 9:00am, the patient also received a first dose of MMR II (Lot # 662437/1251X) subcutaneously in the right tricep and a first dose of FLUZONE (lot#UT2782CA) intramuscularly in the left deltoid. There was no illness at the time of vaccination. On 10-Nov-2008, the patient developed bump at the left tricep area. On 13-Nov-2008 the patient came into the office for observation. She had a 2cm by 1cm area pink patch with induration (1cm). The area had no apparent tenderness and was not warm. It was reported that the area was warm prior and also was more red and the site was improving. The patient was not afebrile. Topical hydrocortisone acetate cream was placed to the area. The patient recovered on an unspecified date. Information / Follow-up information received on 08-Jan-2009 contained the following adverse experiences: hives with eggs (November 2008). Additional information is not expected.				Y					Y	10/31/2008	11/01/2008	1	None	PVT	PVT	Tylenol	Eczema			WAES0811USA02212	1						1	Injection site erythema; Injection site induration; Injection site mass; Injection site warmth; Urticaria	FLU3~SANOFI PASTEUR~UT278CA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~662437/1251X~1~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~661649/1156X~1~SC~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0347513	05/21/2009	CA	1.0	1	.0	F	05/15/2009	Information has been received from a nurse concerning a 12 month old female who on 22-DEC-2008 was vaccinated with a first dose of VARIVAX (Oka/Merck) (lot # 661006/1321X). Concomitant vaccinations included MMR II and FLUMIST. It was reported that the patient came back to the physician's office on 15-JAN-2009 for an unrelated appointment and told the nurse that immediately after the vaccination, on 22-DEC-2009, the injection site was red, hot and inflamed, and then a day later, on 23-DEC-2008 the injection site was blue. Then 12 days after the vaccination, on 03-JAN-2009 the injection site turned blue a scab formed and the scab was still there on 15-JAN-2009, but there was no pain. No lab tests were performed. As of 15-JAN-2009, the patient was recovering. Follow-up information was received from the physician. On 22-DEC-2008, the patient with no medical history and an drug allergy was vaccinated with a dose of VARIVAX (Oka/Merck) into the left leg and a dose of MMR II into the right leg at 12 month old. There is no illness at time of vaccination. Per patients mother, 12 days later, on 03-JAN-2009 a scab formed at the injection site. The patient was seen on 14-JAN-2009 for an unrelated reason. The scab was still present at that appointment. No other symptoms were present. No lab tests were performed. The physician reported that the patient recovered on an unspecified date. Additional information is not expected.				Y					Y	12/22/2008	12/22/2008	0	None	PVT	PVT			None		WAES0901USA02045	1						1	Immediate post-injection reaction; Injection site discolouration; Injection site erythema; Injection site inflammation; Injection site scab; Injection site warmth	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~MERCK & CO. INC.~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1321X~1~UN~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0347603	05/21/2009	MA	1.1	1	.1	M	05/15/2009	Information has been received from a licensed practical nurse concerning a 40 month old male, weight 29.5lb height 35 inches, who on 28-Feb-2006 was vaccinated with VARIVAX (Oka/Merck) (Lot#: 650233/0912R) SQ and (CRM197) PRENVAR (lot#: B08643A) IM and FLUZONE (lot#:B08643A) IM and FLUZONE (lot#: 41804AA) IM. On 23-Jun-2008 the patient developed papular/pustules lesions in trunk, scalp and a few in arms. The patient's outcome was not reported. It was unspecified if the patient sought medical attention. Additional information has been requested.									U	02/28/2006	06/23/2008	846	Unknown	OTH	PUB	Unknown		Public Funds		WAES0807USA03035	1						1	Rash papular; Rash pustular	FLUX~SANOFI PASTEUR~41804AA~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PNC~PFIZER\WYETH~B08643A~UNK~IM~UN~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0912R~UNK~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0344399	05/22/2009		64.0			M	05/20/2009	Initial report (abstract) received 12 May 2009 from a literature citation. A 64-year-old male was admitted to the hospital after becoming unresponsive four and a half weeks after he had received an inactivated Influenza vaccine (manufacturer unknown, lot number not reported). The family reported a two day history of rectal bleeding prior to admission and the patient was unresponsive for one hour prior to presentation. He had a past history of atrial fibrillation, chronic obstructive pulmonary disease, hypercholesterolemia, type II diabetes mellitus, depression, hypertension, and gastroesophageal reflux disease. The patient had been taking warfarin 5 mg every other day alternating with 2.5 mg for stroke prophylaxis, secondary to atrial fibrillation. Additional concomitant medications included Celecoxib, ipratropium/albuterol inhaler, Diltiazem, Metformin, Hydrochlorthiazide/losartan, escitalopram, Lansoprazole, Propranolol and Ezetimibe/simvastatin. The patient had no recent changes in medical conditions or medication regimens and their international normalized ration levels were relatively stable during the previous six months, ranging between 1.4 and 4.7. At the time of vaccination, the patient's INR 2.0. Upon hospital admission, the patient's INR was greater than 15. The patient's blood pressure was 166/60, heart rate 62, and respiration's 16. Additional laboratory test results included hemoglobin 8.3 g/dL (ref 14-18), hematocrit 24% (ref 42-52), platelet 412x10(3)/uL (ref 150-430), serum albumin 3.1 g/dL (ref 3.5-5.0) and normal total bilirubin 0.8 mg/dL (ref 0.2-1.0), aspartate aminotransferase 16 IU/L (ref 10-42) and alanine aminotransferase 12 IU/L (ref 10-40). A CT scan of the head showed large parenchymal hemorrhagic infarction involving the left temporal, parietal, and occipital lobes; significant mass effect including 12mm rightward midline shift and impending uncal herniation. Corrective treatments included a nitroglycerin infusion to maintain systolic blood pressure in the range of 140-160- mm Hg, an infusion of four units of fresh frozen plasma, and 10 mg of vitamin K. Following a neurosurgery evaluation, it was determined that treatments could not improve the patient's outcome positively, comfort measures were implemented, and the patient died approximately 17 hours after admission (date not reported). The authors noted that drug interactions involving Celecoxib, Lansoprazole, and Simvastatin were considered unlikely potential causes of the high INR as there were no recent changes in medication regimens or usage. It was further noted that the patient had received previous inactivated Influenza vaccine administration during Warfarin therapy with no observed complications. According to the authors, the Horn Drug Interaction Probability Scale indicated a possible interaction between warfarin and Influenza vaccination, and the patient's significant INR elevation, after being relatively stable for at least six months, was thought to be due to an interaction between warfarin and the influenza vaccination. Documents held by sender: None.	Y				Y	0			N				4 1/2 weeks prior to hospitalization - INR was 2.0. INRs over the previous six months were relatively stable. Additional labs upon presenting to ER: INR>15, hemoglobin 8.3 g/dL, hematocrit 24%, plagelet 412x10 (3) /uL, serum albumin 3.1 g/dL and normal total bilirubin 0.8 mg/dL, aspartate aminotransferase 16 IU/L and alanine aminotransferase 12 IU/L. CT Scan (head - non contrast) -showed large parenchymal hemorrhagic infarction involving the left temporal, parietal, and occipital lobes; significant mass effect including 12mm rightward midline shift and impending uncal herniation.	UNK	UNK	Warfarin; Celecoxib; Ipratropium/abuterol; Diltiazem; Metformin; Hydrochlorthiazide/Losartan; Escitalopram; Lansoprazole; Propranolol; Ezetimiee/Simvastatin		The patient had a history of atrial fibrillation, chronic obstructive pulmonary disease, hypercholesterolemia, type II diabetes mellitus, depression, hypertension, and gastroesophageal reflux disease.		200902135	1						2	Cerebral infarction; Computerised tomogram abnormal; Death; Haemorrhage intracranial; International normalised ratio fluctuation; Rectal haemorrhage; Unresponsive to stimuli; Alanine aminotransferase normal; Aspartate aminotransferase normal; Blood albumin decreased; Blood bilirubin normal; Blood product transfusion; Brain herniation; Brain mass; Computerised tomogram abnormal; Death; Haematocrit decreased; Haemoglobin decreased; Haemorrhagic infarction; International normalised ratio increased; Platelet count normal; Rectal haemorrhage; Unresponsive to stimuli; Alanine aminotransferase normal; Aspartate aminotransferase normal; Blood albumin decreased; Blood bilirubin normal; Blood product transfusion; Computerised tomogram abnormal; Computerised tomogram head; Death; Haematocrit decreased; Haemoglobin decreased; Haemorrhagic cerebral infarction; Heart rate normal; International normalised ratio increased; Platelet count normal; Rectal haemorrhage; Respiratory rate; Unresponsive to stimuli; Alanine aminotransferase normal; Aspartate aminotransferase normal; Blood albumin decreased; Blood bilirubin normal; Blood product transfusion; Cerebral infarction; Computerised tomogram abnormal; Death; Haematocrit decreased; Haemoglobin decreased; Haemorrhagic infarction; International normalised ratio increased; Platelet count normal; Rectal haemorrhage; Unresponsive to stimuli	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|FLU3~CSL LIMITED~~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~4	USA	Results in Death	Influenza
0346960	05/22/2009	TX		26		M		None stated.									Y	05/15/2009				PUB	OTH						1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA161AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0346966	05/22/2009	MA	70.0	70		F	05/19/2009	Apparent vaccine failure. Pt presented 5/18/09 with typical herpes zoster skin lesions.									U	10/12/2007	05/08/2009	574	None	PVT	OTH	ATENOLOL 25mg qd	None	Lansoprazole; clarithromycin; amoxicillin			1						1	Herpes zoster; Skin lesion; Vaccination failure	FLUX~SANOFI PASTEUR~U2446AA~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~0619U~UNK~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0347055	05/22/2009	TX	40.0	40		M	05/22/2009	None stated									Y	05/22/2009			None	PVT	PVT	SIVASTIN	None	None			1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA381AA~1~~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|TDAP~SANOFI PASTEUR~A011A~1~~LA~TDAP (ADACEL)~1	USA		Influenza
0347198	05/26/2009	NJ	63.0	63		F	10/21/2008	Initial non-serious case received from a consumer on 15 October 2008.  A 63-year-old female patient with history of diabetes, asthma and allergies to adhesive and thimerosal received a 0.25ml dose of FLUZONE No Preservative 2008-2009 (lot number and route/site of administration not reported) on 13 October 2008 and within minutes, the site was red and itchy.  A bandaid was placed over the site.  When removing the bandaid, a two inch welt was noticed.  On the evening of 14 October 2008, a very itchy red blotch, approximately the size of a dime, was noticed on the patient's right calf.  Patient outcome was reported as 'not recovered'.  Documents held by sender:  None				Y					Y	10/13/2008	10/13/2008	0	Not reported.	PVT	UNK	CORGARD;  Vitamins	None	The patient had a history of diabetes, asthma and allergies to adhesives, thimerosal, etc.  Concomitant medications: CORGARD and vitamins.  The patient denied having any illnesses at the time of vaccination.  It was reported that the patient had not experienced any adverse events following prior vaccinations.		200803227	1						1	Injection site erythema; Injection site pruritus; Injection site reaction; Injection site urticaria; Rash macular; Urticaria	FLU3~SANOFI PASTEUR~UT2783DA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0347246	05/26/2009	TX	26.0	26		F	05/21/2009	None									Y	05/21/2009				PVT	PVT		None	Bananas; adhesive; Allergies only			1						1	Unevaluable event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA381AA~2~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0347265	05/26/2009	SC	14.0	14		M	05/26/2009	Several weeks (end of November) after getting flu vaccine, client began experiencing weakness in legs with numbness in feet and toes.  He began walking with a cane and 2 days later he was in a wheelchair.  Family took client to the ER when he couldn't swallow.  Admitted to hospital on December 3rd, 2007, and diagnosed with Guillian-Barre Syndrome.  He was on life support X 17 days and in ICU X 1 month.  Transferred to rehab center. 5/27/09-records submitted with report-Presented on 12/2/08 with 10 day history of increasing weakness and numbness of feet which made an ascending pattern up entire body. 4 days prior began with feelings of breathlessness and day before presenting to ED C/O trouble with swallowing and muffled speech. Elevated BP on admission 148/99 and subsequent transient increase in BP. Treated with IVIG. Mechanical ventilation required with intubation and subsequent extubation. NG feedings. DX: Guillain-Barre syndrome.  One month hospitalization. Office visit follow up 1/23/09 residual weakness on both sides of face, CN VII focally affected R>L.   6/26/09 Hospital records and DC summary recieved. DOS 12/02/07 to 01/04/08. Assessment: Ascending paralysis, probable Guillain-Barre. Patient presented with ascending numbness and weakness. Nausea and vomitjng. Numbness in feet. Difficulty swallowing liquids. Unable to walk or sit up on his own. DTR's absent. Stregnth diminished upper and lower extremities. Fever, headache. Sedation/Analgesia dependence. Agitation with respiratory distress. Hypertension. IVIG administered. Transferred to rehabilitation facility.  ICD-9 Codes: 357.0, 518.81, V46.11, 707.03, 292.0, 304.01, 112.0, 401.9, 075, 726.87, 041.5, 564.00, 110.5			Y	Y	Y	10	Y	Y	N	10/30/2007	11/21/2007	22	Medical records from Hospital included (will be faxed to VAERS) 5/27/09-records received- WBC 12.5. Positive mono spot. Positive EVB titers. Respiratory culture positive for haemophilus influenza and streptococcus pneumonia.LFTs elevated with ALT of 187 and AST of 80. Lumbar puncture protein 240, glucose 72, 4 nucleated cells. 6/26/09 Hospital records and DC summary recieved. DOS 12/02/07 to 01/04/08. LABS and DIAGNOSTICS: Lumbar Puncture - protein 240, glucose 72, 4 nucleated cells, 0 red blood cells. EBV Titers (+). Haemophilus Influenza Culture (+). Strep pneumonia Culture (+). CT Head - No Evidence of Acute Intracranial Hemorrhage or Hydrocephalus. Chest X-Ray - Lungs mildly hypoinflated, mild vascular prominence. CDC - WBC 12.5 (H), H and H 18 over 52, 371,000 platelets, 56 neutrophils, 23 lymphs, 9 monos. BMP soidum 137, potassium 4.4, chloride 103, bicarb 22, BUN 20, creatinine 0.7, glucose 109, calcium 10.9. LFT elevated - ALT 187 and AST 80.	UNK	UNK	NONE	NONE	NONE		SC0915	1						1	Dysphagia; Guillain-Barre syndrome; Hypoaesthesia; Intensive care; Muscular weakness; Wheelchair user	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80433~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0347448	05/27/2009	OR	45.0	45		F		None stated. 9/9/09 Rheumatology consultant records received DOS 1/5/05 to 6/17/09. Assessment: Rheumatoid arthritis, uncontrolled anxiety. Patient presented with pain in (L) shoulder, (L) knee, hands and feet. Unable to lift (L) arm above head. Swelling in hands, nodules. Multiple joint swelling. Fatigue, weight loss, inability to function. Wrist pain. 'Hole in back of mouth'. Nausea, vomiting, dizzy, and sick. Left-sided chest pain. Lightheaded. Synovitis multiple joints. H. Pylori and diverticulosis. Vision and dental concerns.								Y	Y	11/10/2003			9/9/09 Rheumatology consultant records received DOS 1/5/05 to 6/17/09. LABS and DIAGNOSTICS; PPD (-) Chest X-ray (-). Mammogram - Abnormal. Esophagogastroduodenoscopy, colonoscopy. Rheumatoid Factor - High end of normal. Anti-cyclic citrullinated peptide (+). ANA (+). Complement Levels - Normal	PVT	UNK		None	9/9/09 Rheumatology consultant records received DOS 1/5/05 to 6/17/09.  Coronary artery disease post myocardial infarction with stent. Anxiety, asthma, obstructive sleep apnea, hypertension, GERD, MVA, headaches.			1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~765416~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0347459	05/27/2009	TX	14.0	14		M	05/22/2009	Initial report received on 13 May 2009 from a physician. Subject identification number: 1-08-06459. This subject is participating in a study. A 14-year-old previously healthy male subject, who has concurrent medical condition of mild asthma, for which he uses XOPENEX on an as needed basis, had received on 30 November 2008 a dose of FLUZONE, lot number U2803AA. The route and site of administration was not reported. The subject presented with prolonged, generalized new onset of seizure and status epilepticus (onset date not reported) and was hospitalized from 30 November 2008 to 02 December 2008. There was no history of trauma, or substance abuse. Urine drug screen was negative. An MRI with/without contrast on 01 December 2008 revealed no intracranial abnormalities and with abnormal signal in the left middle ear cavity and mastoid region. An EEG was normal without epileptiform discharges. Cerebral spinal fluid Polymerase Chain Reaction was negative for enterovirus and herpes simplex virus. Blood culture was sterile. It was elected to observe the subject without anti-epileptic medication. The subject was discharged on hospital day three. The subject was re-admitted two days later from 04 December 2008 to 06 December 2008 for seizures (onset date not reported). The subject was loaded with fosphenytoin and ATIVAN. Urine drug screen was negative. Head CAT scan did not reveal hemorrhage or other intracranial pathology. A soft tissue density in the left mastoid was observed consistent with cholesteatoma. The subject was discharged home on hospital day three with KEPPRA 300 mg twice a day for prevention of seizures. The subject was re-admitted three days later from 09 December 2008 to 24 December 2008 for seizures (onset not reported). A lumbar puncture test was performed that revealing CSF protein of 50.9 mg/dL and glucose of 71mg/dL, both are within normal values. Urine drug screen was negative, repeat CAT scan of the head did not reveal any new findings, respiratory virus panel was negative and an EEG revealed marked slowing of the background consistent with persistent encephalopathy without accompanying seizure activity. A repeat EEG on 15 December 2008 revealed discharge events indicative of myoclonic seizures. The subject had an EKG that had ventricular tachycardia; however an echocardiogram of the heart was normal. Muscle and skin biopsy of the left thigh was performed to evaluate for progressive myoclonic epilepsy of the Lafora type; however, results of pathology test demonstrated no globules consistent with Lafora. Ophthalmologic examination was unremarkable. The subject was sent home on hospital day 16 on DEPAKOTE 1500 mg twice a day and rectal DIASTAT 17.5 mg for seizures lasting greater than five minutes. The subject's final diagnosis was new onset seizure, status epilepticus, myoclonic epilepsy. Recovery dates were not reported. Per the reporter, none of the three serious adverse events were related to the he FLUZONE, and the SAEs not going to be reported to the IRB, or to VAERS. Documents held by sender: None.					Y	3			U	11/03/2008			30 November 2008 to 02 December 2008:  Urine drug screen was negative.  An MRI with/without contrast on 01 December 2008 revealed no intracranial abnormalities and with abnormal signal in the left middle ear cavity and mastoid region.  An EEG was abnormal without epileptiform discharges.  Cerebral spinal fluid PCR was negative for enterovirus and herpes simplex virus.  Blood culture was sterile.  04 December 2008 to 06 December 2008:  Urine drug screen was negative.  Head CAT scan did not reveal hemorrhage or other intracranial pathology.  A soft tissue density in the left mastoid was observed consistent with cholesteatoma.  09 December 2008 to 24 December 2008:  A lumbar puncture test was performed that revealed CSF protein 50.9 mg/dL and glucose of 71mg/dL, both are within normal values.  Urine drug screen was negative.  A repeat CAT scan of the head did not reveal any new finding.  Respiratory virus panel was negative.  An EEG revealed marked slowing of the background consistent with persistent encephalopathy without accompanying seizure activity.  A repeat EEG on 15 December 2008 revealed discharge events indicative of myoclonic seizures.  The patient had an EKG that had ventricular tachycardia.  An echocardiogram of the heart was normal.  Muscle skin biopsy of the left thigh was performed to evaluate for progressive myoclonic epilepsy of the Lafora type; however, results of pathology test read at the hospital demonstrated no globules consistent with Lafora.  Ophthalmologic examination was unremarkable.	UNK	UNK	XOPENEX		A healthy male with no recent history of trauma or substance abuse, but who has current medical condition of mild asthma for which he uses Xopenex on an as needed basis.		200902175	1						1	Biopsy muscle normal; Blood culture negative; Blood glucose normal; CSF protein normal; Cholesteatoma; Computerised tomogram abnormal; Convulsion; Drug screen negative; Echocardiogram normal; Electrocardiogram abnormal; Electroencephalogram abnormal; Lumbar puncture normal; Myoclonic epilepsy; Nuclear magnetic resonance imaging abnormal; Ophthalmological examination normal; Soft tissue disorder; Status epilepticus; Ventricular tachycardia	FLU3~SANOFI PASTEUR~U2803A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0347461	05/27/2009	TX	13.0	13		M	05/22/2009	Initial report received on 13 May 2009 from a physician. This subject is participating in a non sponsored Sanofi Pasteur study. This case involved a 13-year-old male subject, with a history of bipolar disorder, benign familial choreoathetosis, high cholesterol and high triglycerides, who was hospitalized on 18 November 2008 through 20 November 2008 for evaluation of pain and swelling of the left side of his face after receiving a dose of FLUZONE SV 2008-2009 (lot number U2803AA) that was administered on 18 October 2008. The route and site of administration was not reported. The subject has two dogs and two cats at home. The subject was taking concomitant medications of Metformin and SYNTHROID (indications not reported) along with DEPAKOTE, SEROQUEL, ZOCOR, PROZAC and simvastatin. The illness started in the first week of November 2008 with left eye pain and photophobia. These symptoms worsened and the subject was evaluated at a health care facility on 11 November 2008, where he was referred directly to the ophthalmology clinic. The subject's photophobia resolved and he was subsequently re-evaluated on 18 November 2008 for swelling of his face over the angle of the jaw. X-ray of the mandible was unremarkable and serology studies for Epstein Barr virus and Bartonella henselae were not diagnostic. At the time of hospitalization, the subject's examination was remarkable for swelling in the left parotid area with significant sensitivity to light touch which resulted in pain in the left parotid area extending into his neck. Group A a-haemolytic streptococci throat culture was negative and the serum amylase level (35 U/L) was within normal values. The subject was started on intravenous Rocephin and clindamycin, and by the second hospital day the subject had decreased swelling and decreased tenderness in the left mandibular area. The subject was discharged home on hospital day three with clindamycin 150 mg three times a day for five days and Tylenol # 3 for pain. The final diagnosis was determined to be cervical adenitis. Recovery status was not reported. Per the reporter, the event was not related to the FLUZONE vaccine, and the SAE was not going to be reported to the agency, or VAERS. Documents held by sender: None.					Y	3			U	10/18/2008	11/01/2008	14	X-ray of the mandible was unremarkable, and serology studies for Epstein Bar virus and Bartonella henselae were not diagnostic.  Group A a-haemolytic streptococci throat culture was negative and the serum amylase level (35 U/L) was within normal values.	UNK	UNK	DEPAKOTE; SEROQUEL; Metformin; ZOCOR; SYNTHROID; PROZAC; Simvastatin		The subject has a history of bipolar disorder, benign familial choreoathetosis, high cholesterol and high triglycerides. The subject has two dogs and two cats at home. The subject was taking concomitant medications of Metformin and SYNTHROID (indications not reported) along with DEPAKOTE, SEROQUEL, ZOCOR, PROZAC and simvastatin.		200902176	1						1	Blood amylase normal; Culture throat negative; Epstein-Barr virus test negative; Eye pain; Facial pain; Lymphadenitis; Neck pain; Photophobia; Salivary gland pain; Swelling face; X-ray normal; Blood amylase normal; Culture throat negative; Epstein-Barr virus test negative; Eye pain; Facial pain; Hyperaesthesia; Lymphadenitis; Neck pain; Parotid gland enlargement; Photophobia; Salivary gland pain; Streptococcal identification test negative; Swelling face; X-ray normal	FLU3~SANOFI PASTEUR~U2803A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2803A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0347463	05/27/2009	TX	16.0	16		F	05/22/2009	Initial report received on 13 May 2009 from a physician. This subject is participating in a non sponsored Sanofi Pasteur study. This case involves a 16-year-old female subject, with a history of bipolar disorder, oppositional defiant disorder, attention deficit-hyperactivity disorder, post-traumatic stress disorder due to prior abuse from mother and parent-child relationship problems, who had received a dose of FLUZONE SV 2008-2009 (lot number U2803AA) that was administered on 04 November 2008. The route and site of administration was not reported. The subject was evaluated at the emergency room on 08 December 2008 for emotional issues with suicidal ideation. A urine drug screen was negative and her TSH level (1.64 mcU/ml) was normal. Serum lithium level was within the therapeutic range (0.6) mEq/L). The subject was admitted for observation and management. Her in-patient stay was for approximately one week. After discharge from the hospital, the subject received individual and family therapy sessions for her current issues on at least the following dates: 17 December 2008, 22 December 2008 and 21 January 2009. The final diagnosis was suicidal ideation. The recovery status of the subject was not reported. Per the reporter, the SAE was not related to the FLUZONE vaccine and will not be reported to the agency, or to VAERS. Documents held by sender: None.					Y	7			U	11/04/2008			A urine drug screen was negative and her TSH level (1.64 mcU/ml) was normal.  Serum lithium level was within the therapeutic range (0.6) mEq/L).	UNK	UNK	LITHIUM; RISPERDAL; CONCERTA; ZOLOFT		The subject has a history of bipolar disorder, oppositional defiant disorder, attention deficit-hyperactivity disorder, post-traumatic stress disorder due to prior abuse from mother, and parent-child relationship problems.  The subject takes concomitant medications of Lithium, Risperdal, Concerta and Zoloft.		200902177	1						1	Antipsychotic drug level; Blood thyroid stimulating hormone; Drug screen negative; Suicidal ideation; Antipsychotic drug level; Blood thyroid stimulating hormone normal; Drug screen negative; Emotional disorder; Suicidal ideation	FLU3~SANOFI PASTEUR~U2803A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2803A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0347469	05/27/2009	IL	25.0	25		M	05/20/2009	C/o tightness in chest & throat 20 mins after receiving vaccines and ERYTHROMYCIN. Has allergy to CECLOR, was given BENADRYL returned to division.									Y	05/04/2009	05/04/2009	0		MIL	MIL	E-mycin - not taken yet					1						1	Chest discomfort; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AF11A192AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB155AA~1~IM~LA~HEP A + HEP B (TWINRIX)~1|MMR~MERCK & CO. INC.~0915X~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|MNQ~SANOFI PASTEUR~U2875AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B036BA~1~IM~RA~TDAP (BOOSTRIX)~1	USA		Influenza
0347470	05/27/2009	IL	22.0	22		F	05/28/2009	C/o swelling of throat after receiving vaccine and Bicillin, no prior allergy history. Given BENADRYL and observation - return to division.									Y	05/13/2009	05/13/2009	0		MIL	MIL	BICILLIN; BENADRYL					1						1	Pharyngeal oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AF11A192~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB162AA~1~IM~LA~HEP A + HEP B (TWINRIX)~1|MMR~MERCK & CO. INC.~0426Y~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|MNQ~SANOFI PASTEUR~U2922AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B036BA~1~IM~RA~TDAP (BOOSTRIX)~1	USA		Influenza
0347479	05/27/2009	NC				U		None stated.										05/19/2009				UNK	UNK						1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88907~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB225CA~UNK~UN~LA~HEP A (HAVRIX)~1	USA		Influenza
0347545	05/27/2009	CA	49.0			F	05/27/2009	Severe Hair loss (alopecia) around temples (around ear area, mainly in front) and some hair loss around hair line and crown. Has happened the last 3 years in October-November after administration of the Influenza vaccine (first vaccine in 2006). Noticeable loss each year starting approximately 30 days after administration of vaccines.				Y					N				blood tests - endocrinologist and gynecologist, several visits to dermatologists - had cortisone shots in temples	PUB	UNK						1						1	Alopecia; Blood test	FLUX~UNKNOWN MANUFACTURER~unknown~3~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0347552	05/27/2009	MD	20.0	20		F	05/27/2009	10July08-First Anthrax  vaccination was issued in my left arm.  Two days later my arm started to swell and became red at the injection site.  This adverse reaction lasted approximately one week after getting the vaccine.  I was bed ridden for three days; however, I decided not to go to the hospital because I was already off duty for the days I was ill. 04May09- Second Anthrax vaccination was issued in my right arm.  My right arm was very sore and became red and very swollen for approximately a week and a half after the vaccine was issued.  I was unable to move it without being in extreme pain. I had to prop it up while sitting or laying down. I was unable to sleep on it or move it while walking.  I took over the counter medication to relieve some pain, but it didn't help much so I decided not to take it again.									Y	05/04/2009	05/05/2009	1	none known	MIL	MIL	NONE KNOWN	NONE KNOWN	NONE KNOWN			1						1	Activities of daily living impaired; Injection site erythema; Injection site swelling; Mobility decreased; Tenderness	ANTH~EMERGENT BIOSOLUTIONS~FAV169~2~IM~RA~ANTHRAX (BIOTHRAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFA192AA~4~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0347587	05/27/2009	MN	9.0	9		M	05/26/2009	No adverse event.  Mis administration of TDAP.  Pt is 9 yrs old - should of been TD.										11/13/2008				PUB	PUB		None				1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U2853AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB244BA~1~IM~UN~HEP A (HAVRIX)~1|TDAP~SANOFI PASTEUR~UF455BA~1~IM~UN~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~0950X~2~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0347749	05/28/2009	PA	1.5	1	.5	F	05/21/2009	Papular (raised) rash in crops over the antero-medical aspect of left thigh no erythema.									Y	03/26/2009	05/01/2009	36		PVT	PVT		None				1						1	Injection site rash; Rash papular	FLUX~SANOFI PASTEUR~UT2794CA~2~UN~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PNC~PFIZER\WYETH~D21051~4~UN~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0347957	05/28/2009	TX	44.0	44		M	05/28/2009	2 days post 1st dose pt noted flashes in visual field and fatigue.  Inc in flashes after 2nd dose.  Reported dec in visual field 2-3 days post 3rd dose, Inc in flashes and severe eye pains.  Symptoms:  Pain.  Dx Optic Neuritis in 06.  7/31/09 Medical records received DOS 6/13/06 to 2/27/09. Assessment: Optic Neuritis. Quadrantanopsia, myopia, astigmatism. Ischemic optic neuropathy: optic neuropathy of unknown origin. Eye flashes, sharp pain, dull ache. Visual field loss. Visual impairment. Difficulty breathing. Upper respiratory infection. Closed fracture of talus. Viral syndrome. Patellorfemoral syndrome.				Y					Y	02/23/2005			7/31/09 Medical records received DOS 6/13/06 to 2/27/09. LABS and DIAGNOSTICS: Pulmonary function tests - Mildly reduced lung volumes. Elevated ACE. MRI Orbits - Abnormal, optic nerve atrophy, sinus disease. Glucose 181 mg/dl. Right optic disc atrophic. CT Chest - abnormal, calcified granuloma.	MIL	MIL	denies	Viral illness	7/31/09 Medical records received DOS 6/13/06 to 2/27/09. Peritonsillar abcess, conjuntivitis chronic allergic.			1						1	Eye pain; Fatigue; Optic neuritis; Visual acuity reduced	FLUX~UNKNOWN MANUFACTURER~U1557AA~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~0794P~UNK~IM~UN~HEP B (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0348128	05/29/2009		19.0			F	05/29/2009	We received from a consumer the following information on 14 May 2009: A female patient was vaccinated with Influenza virus vaccine (batch no. or manufacturer unknown) in Nov 2007. In November 2007 she experienced two grand mal seizures. On 07 Nov 2007 she was placed on Tegretol to treat the seizures. In 2007 the patient also experienced a rash all over her body. In Jan 2009 she was switched to Tegretol XR and the event continued (unclear which of both events continued). No further information had been provided. Company assessment : Serious criterion: medically significant. Causality: Insufficient data. The amount of data is not sufficient to finally assess causality. Expectedness assessment according to product information: Grand mal seizure is unexpected, rash all over the body is expected after vaccination with Fluvirin, Begrivac, Agrippal, or Fluad. On a case level, the case is considered unexpected. No change in benefit-risk-ratio. No measures necessary. Ref no:NA09-001601. On 01 JUN 2009 we received the following information: Made several unsuccessful attempts to contact the reporter to obtain additional information. On 02 JUN 2009 we received the following information: Due to an internal mistake we have to correct the initial receive date from 14 MAY 2009 to 13 MAY 2009. We received the following information from a physician on 13 MAY 2009 (due to an internal oversight identified only on 17 JUN 2009). A 19-year-old woman was vaccinated with influenza virus vaccine (batch no. and manufacturer unknown) in NOV 2007. On 02 JUN 2009 we received the same information as on 13 MAY 2009 (due to an internal oversight identified only on 17 JUN 2009). Other no.: PHEH2009US. Other no.: S2009US.									N	11/01/2007	11/01/2007	0		OTH	OTH	No other medications	Unknown			MA20091372	1						1	Grand mal convulsion; Rash generalised	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0348235	06/01/2009	MD	70.0	70		M		11:30 AM severe hives.				Y					Y	10/19/2008	10/19/2008	0		PVT	PVT						1						1	Urticaria	DTOX~UNKNOWN MANUFACTURER~~UNK~UN~UN~DIPHTHERIA TOXOIDS (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~UN~UN~TETANUS TOXOID (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0348263	06/01/2009	NC	3.0	3		F	06/01/2009	Based on photographs the patient developed right sided ptosis and an enlarged pupil between September 1st and 7th.  The parents noticed abnormal gaze in February (maybe in Oct/November using retrospective look at photographs) and sought care.  In February she was complaining of double vision.  She was found to have 3rd nerve palsy. She was sent for neurology and ophthamology and neurophthamology - had studies done including myasthenia gravis panel, CT angiogram, MR angiogram, MRI, thyroid studies, and some screening autoimmune and inflammatory disease labs all of which were unrevealing by report, except an apparently abnormal ANA (result not known).  She had a trial of Mestinon 12mg TID without help. 6/11/09 office note for 9/4/08 received C/O right hip pain. Left eye complaint, red, dilated, double vision, right eye dilated not reactive, lid ptosis and limited full EOM. Three weeks prior c/O eye turning out.   6/11/09 Neurology records received DOS 3/10/09 to 5/18/09. Assessment: Idiopathic 3rd nerve palsy. Post vaccination: double vision, squinting, pupillary discrepancy, disconjugate gaze and intermittent ptosis. Difficulty with adduction and upgaze of right eye. Ophthalmologic surgery planned.  9/16/09 Ophthlamology Consult DOS 3/19/09 to 4/6/09. Assessment: Third nerve palsy of right eye. Right pupil dilated. Inability to raise or depress right eye. Ptosis of right upper eyelid.  Follow-up: She continues with 3rd nerve palsy. Some mobility is returning but she's not fully recovered.								Y	N	09/04/2008	09/07/2008	3	See above. 6/11/09 Neurology records received DOS 3/10/09 to 5/18/09. LABS and DIAGNOSTICS: CHEM - Bilirubin 0.3 mg/dL (L) Alk Phos 240 U/L (H). ANA Screen (+). MRI Brain MRA head neck - All WNL. 9/16/09 Ophthlamology Consult DOS 3/19/09 to 4/6/09. LABS and DIAGNOSTICS: MRA - Normal.	UNK	UNK			febrile seizure at 14 mos.			1						1	Angiogram; Antinuclear antibody positive; Apraxia; Blood alkaline phosphatase increased; Blood bilirubin normal; Diplopia; Eyelid ptosis; IIIrd nerve paralysis; Laboratory test normal; Nuclear magnetic resonance imaging normal; Pupil fixed; Pupillary disorder; Strabismus; Thyroid function test normal; Blindness; Eye disorder; IIIrd nerve paralysis; Mydriasis; Wrong technique in drug usage process	FLUN3~MEDIMMUNE VACCINES, INC.~500543P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB289BA~2~IM~LL~HEP A (HAVRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Disabling	Influenza
0348294	06/02/2009	LA	57.0	57		M	05/26/2009	Numbness in face, body, hands, feet BELL's Palsy in face. Losing ability to walk. Low blood pressure readings. Kidney (not normal readings). MRI's (5-6). Spinal tap. Plasma phoresis (5). Surgery to insert shunt.  6/22/09 Hospital records DC summary received DOS 12/29/08 to 01/11/09. Assessment: Guillain-Barre versus CIDP Patient presents with unsteady gait and lower back pain. Facial weakness and numbness of all extremities. Sensation impaired for pain and proprioception. Plasmapherisis performed.  ICD-9 Codes: 781.2 Abnormality of Gait, 357.0 Ac Infect Polyneuritis, 357.81 Chr Inflam Polyneuritis, 458.29 Iatrogenic Hypotension, 276.51 Dehydration, 401.9 Hypertension, 720.0 Ankylosing Spondylitis, 721.0 Cervical Spondylosis.			Y	Y	Y	14	Y		Y	10/18/2008	11/01/2008	14	Urine samples; Surgery to insert shunt; MRI's; Spinal tap; Plasma Phoresis; blood-work.  6/22/09 Hospital records DC summary received DOS 12/29/08 to 01/11/09. LABS and DIAGNOSTICS: No EMG or Nerve Conduction Studies. MRI Thoracic Spine - Degenerative changes, intraosseous hemangioma. MRI Lumbar Spine - Degenerative disk changes and facet arthropathy. MRI Cervical Spine - Multilevel disk degenerative disease. MRI Brain - No abnormalities. CBC - WBC 11.4 1000/uL. CHEM - Potassium 5.4 mEq/L (H) Glucose 124 mg/dL (H) Creatinine 1.7 mg/dL (H) Calcium 8.7 mg/dL (L) Total Protein 5.6 gm/dL (L) Alk Phos 23 U/L (L). Immunoglobulin A 356.0 mg/dL. CSF - RBC 1445/mm3.	PVT	OTH	see other side	No	ankylosing spondylitis; neuropathy; hypertension. 6/22/09 Hospital records DC summary received DOS 12/29/08 to 01/11/09. Had cold within the past week. Obesity, herniated disc, neuropathy secondary to unknown causes. Hypertension.			1						1	Blood test; Facial palsy; Gait disturbance; Hypoaesthesia; Hypoaesthesia facial; Hypotension; Lumbar puncture; Nuclear magnetic resonance imaging; Plasmapheresis; Renal impairment; Surgery; Urine analysis	FLU3~SANOFI PASTEUR~U2806AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0348297	06/02/2009	NC				U		None stated.									U					OTH	OTH						1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88907~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB583AA~UNK~IM~RA~HEP B (ENGERIX-B)~1	USA		Influenza
0348317	06/02/2009	OR				F	05/29/2009	This case was received from a consumer via Sanofi Aventis on 20 May 2009. A female patient, with a history of Type II diabetes, Hashimoto's thyroiditis, auto-immune disorders, and multiple food and drug allergies, received an influenza vaccine (manufacturer and lot number not reported) in 2001. She subsequently experienced a stroke. No additional information was reported regarding the event. Documents held by sender: None.				Y										UNK	UNK	Lantus; Dhea; Glucosamine sulfate; Gymnema sylvester; HMF PWD; EPA-DHA extra strength; Vitamin D3; Vitamin B Complex; E 400; Grape seed extract; Phyto-B; Biotone; Magnesium; Calcium; Multivitamins; Immunocal; Low-dose Aspirin		Patient had history of Type II Diabetes, Hashimoto's thyroiditis, auto-immune disorders, and multi-level lumbar spinal fusion (06/Apr/2009). Drug allergies included VICODIN, PREMARIN, ESTRADIOL, LEVOXYL, CYTOMEL, IMITREX, MICROBID, BETAHISTINE, AUGMENTIN, OMNICEF, and INSULINS (HUMULIN U, HUMULIN R, HUMULIN N, HUMALONG, and NOVOLOG). The patient also reported multiple food allergies.		200902233	1						1	Cerebrovascular accident	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0348335	06/02/2009	NC				F		None stated.										05/27/2009				UNK	UNK						1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88907~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB583AA~UNK~UN~LA~HEP B (ENGERIX-B)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB302BA~UNK~UN~LA~HEP A (HAVRIX)~1	USA		Influenza
0348338	06/02/2009	GA	1.0	1	.0	M	06/02/2009	Developed diarrhea for 3 weeks, fever, speech and motor regression, has been evaluated for autism by specialist, results inconclusive.  MRI and EEG were normal.									N	11/05/2008	11/08/2008	3	MRI brain nl 1/8/09, Awake and drowsy EEG nl 1/13/09	PVT	PUB			35 week twin gestation, IUGR, h/o maternal chlamydia and tobacco, mom with diet controlled gestational diabetes, breech delivery, h/o cellulitis R ankle MRSA, allergic rhinitis			1						1	Diarrhoea; Electroencephalogram normal; Motor dysfunction; Nuclear magnetic resonance imaging normal; Pyrexia; Regressive behaviour; Speech disorder developmental	FLU3~SANOFI PASTEUR~UT2792CA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB257AA~1~IM~UN~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1083X~1~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1133X~1~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0348339	06/02/2009	GA	1.0	1	.0	M	06/02/2009	Diarrhea x 3 weeks									Y	11/05/2008	11/27/2008	22	None	PVT	PUB			35 week twin gestation, IUGR, maternal chlamydia and tobacco, maternal diet controlled DM, moderate-severe R hydronephrosis	Diarrhea and speech/motor regression, VAERS E-29842~Measles + Mumps + Rubella (MMR II)~0~1.00~In Sibling1|As above~Varicella (Va		1						1	Diarrhoea	FLU3~SANOFI PASTEUR~UT2792CA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB257AA~1~IM~UN~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1083X~1~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1133X~1~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0348342	06/02/2009	OK	2.0	2	.0	F	06/02/2009	Progressing ataxia with onset approximately 11/08. Severe gross motor and fine motor impairment noted.  6/15/09 Received PCP medical records for 11/19/07-04/2009. FINAL DX: ataxia, hypertonia, tremors Records reveal when patient seen 11/19 experienced progressive walking abnormality, falls, irritability, balance difficulty, leg pain, weight loss, shaking, confusion, rhinorrhea, speech regression x 3 wks.  Parent reported symptoms had been present prior to flu vaccine.  Developed fatigue, back pain, excessive sleeping, otitis media w/effusion.  Neuro -ophtho consult done 12/07 dx w/seizure disorder; normal optic nerves & retina; normal hyperopis.  RTC 10/08 w/cough, decreased appetite, nasal congestion/drainage, fever, chills, shaking, falls, unsteady gait.  Dx w/viral URI, gait disturbance.  Referred to Neuro & Ophtho.  Dx w/nystagmus thought to be neurological rather than optho in origin.  Referred to genetics & eval of 4/09 revealed amino acid deficiencies.  9/29/09 Neurology consult records received DOS 12/30/08 to 6/18/09. Assessment: Progressive ataxia. Patient presents with abnormal gait, stumbling and falling. Ataxia, shaking of legs and arms, shaking speech. Gaze jerk nystagmus. Truncal ataxia. Intention tremor, tremor in speech.				Y					N	10/26/2007	11/01/2008	372	Currently undergoing numerous neurological testing: CT scan, MRI, MRS, muscle testing. LABS: MRI brain, EKG, CXR, EMG WNL.  9/29/09 Neurology consult records received DOS 12/30/08 to 6/18/09. LABS and DIAGNOSTICS: Lipoprotein (a) 55 mg/dL elevated. EMG - Normal. Nerve Conduction Studies - Normal. IgA 237 mg/dL (+). Blood Amino Acids - Abnormal, several elevated. Urine Amino Acids - Abnormal, several decreased. Blood  Pyruvic Acid 0.117 mmol/L (H). Blood Alpha Tocopherol 9.8 mg/L (H). Genetic Screen for Neurological Ataxia PCR/Electrophoresis (-). CT Chest - WNL. CT Abdomen - WNL. Brainstem Auditory Evoked Response - WNL. MRI Brain WNL. MR Spectroscopy - Abnormal.	UNK	UNK		none	none  PMH: anemia.  Family hx: early death secondary to amebiasis, childhood leukemia, DM, asthma.			1						1	Ataxia; Motor dysfunction	FLU3~SANOFI PASTEUR~U2508AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0348348	06/02/2009	CA	49.0	48		F	02/05/2009	Patient woke up the next day with raised, itchy rash all over body except on face, chest and upper trunk.  Took OTC medicines and rash lasted 3 weeks.  Reported to PMD and called today 6/2/09 for Lot number and Manufacturer.  Patient has history of allergic reactions to many things but she attributes the rash to Influenza Vaccine received on 12/9/08.									U	12/09/2008	12/10/2008	1		PUB	PUB						1						1	Rash pruritic	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0348465	06/04/2009	WI	64.0	64		M	05/29/2009	None stated.										05/29/2009				PUB	OTH						1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U2750AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0329646	06/05/2009	RI	4.0	4		M	05/01/2009	This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 4-year-old male subject who was vaccinated with (INFANRIX, GlaxoSmithKline). Previous and/or concurrent vaccination included seasonal (FLUZONE, non-gsk); Sanofi; right arm given on 20 October 2008. On 20 October 2008 at 14:15, the subject received 5th dose of INFANRIX (.5 ml, unknown left arm). On 22 October 2008, 2 days after vaccination with INFANRIX, the subject experienced swelling injection site. The sales representative was informed that this pediatric subject received INFANRIX and experienced swelling at the injection site. A FLUZONE vaccine was also given in the right arm and not considered a co-suspect vaccine. The subject's mother brought him into clinic. BENADRYL and cold compresses were prescribed. The mother was also told to outline swelling and monitor for increase in size from 3.5 inches to 3.75 inches. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 01 December 2008, via healthcare professional who reported the subject's events occurred on 22 October 2008 and resolved on 24 October 2008. The reporting healthcare professional considered the events related to vaccination with INFANRIX.				Y					Y	10/20/2008	10/22/2008	2	UNK	PVT	PUB		Unknown	Concomitant medications and relevant medical history was not provided. No adverse events were reported with previous vaccinations.   The healthcare professional reported other cases, see A0749667a and A0755661A		A0755662A	1						2	Injection site swelling	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B085BA~5~UN~RA~DTAP (INFANRIX)~2|FLU3~SANOFI PASTEUR~C2848AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0348610	06/05/2009	NY	69.0	69		F	06/05/2009	Erythema, Swelling, Tenderness, fevers, Elevated white blood cell count. 6/26/2009 MR received for DOS 6/4-7/2009 with D/C DX: Cellulitis.  Pt presented with fever of 104F, redness, induration, warm and tenderness at injection site, chills and malaise.  Seen by surgery-nothing to drain.  Tx IV abx. D/C on abx.   ICD9 780.6.				Y	Y	3	Y		U	06/03/2008	06/04/2008	1	work up in progress. (Blood cultures, Urine cultures, CXR).  Rule out other sources of infxn Labs and Diagnostics:  EKG with non-specific changes.  CBC with WBC 9.6-16.6, RBC 3.43 (L), Hgb 10.7, Hct 31.3. BC (-). UC (-). K+ 3.0.  BS 136. AST 62.	UNK	UNK	Metoprolol, Hyzaar	Syncope	PMH:  HTN.			1						1	Chest X-ray; Erythema; Pyrexia; White blood cell count increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~892972P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0467Y~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0348621	06/05/2009	CA	1.33	1	.4	M	06/05/2009	child experienced generalized macular papular rash over body with strawberry toungue beginning 06/03/09 afebrile									U	05/20/2009	06/02/2009	13	none	UNK	PUB	none	none	NKA, no history of birth defects or medical conditions			1						1	Rash maculo-papular; Strawberry tongue	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B066AA~4~IM~RA~DTAP (INFANRIX)~1|FLUX~SANOFI PASTEUR~UT2794CA~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB25BAA~1~IM~LA~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1505X~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~C05379~4~IM~RA~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1328X~1~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0348649	06/05/2009	VA	81.0			M	06/05/2009	This case was reported by a consumer (also the subject) and described the occurrence of pneumonia in a 81-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline) and received ADVAIR  250/50 multi dose powder inhaler over a period of 18 months for chronic obstructive pulmonary disease. A physician or other health care professional has not verified this report. The subject's medical history included allergy to CEFPODOXIME, CIPRO, SEPTRA, CODEINE, ENDOCET, MEGACE, TRIMADOL and SULFA. The subject had previously received unknown number of influenza vaccinations (manufacturer unknown), with no adverse events. The subject had not experienced adverse events following other previous vaccinations. Concurrent medical conditions included chronic obstructive pulmonary disease. Concurrent vaccination included pneumonia vaccine (non-GSK) (manufacturer unspecified). Concurrent medications included LISINOPRIL, WARFARIN, and DILTIAZEM. On an unknown date in 2007 the subject started Fluticasone propionate+salmeterol xinafoate (inhaled) twice per day. In the Fall of 2008 the subject received unspecified dose of FLUARIX (details unknown). On 24 February 2009, less than one year after vaccination with FLUARIX, the subject experienced pneumonia and runny nose. The subject noted that the pneumonia started out as a runny nose which would not stop. The subject was hospitalised for 6 days. Treatment with Fluticasone propionate+salmeterol xinafoate was continued. At the time of reporting the events were resolved.					Y	6			Y		02/24/2009		UNK	PVT	OTH	LISINOPRIL;  Warfarin sodium;  Diltiazem hydrochloride	Chronic obstructive pulmonary disease	Allergy to CEFPODOXIME;  Allergy to CIPRO;  Allergy to SEPTRA;  CODEINE allergy;  SULFA allergy.  The subject also had allergies to ENDOCET, MEGACE and TRIMADOL.  The subject had previously received unknown number of influenza vaccinations (manufacturer unknown), with no adverse events.  The subject had not experienced adverse events following other previous vaccinations.		A0788583A	1						1	Pneumonia; Rhinorrhoea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0348660	06/05/2009	NJ	24.0	24		M	06/01/2009	5/23/09 - chest & back rash red, bumps mild itching x 1 1/2 hrs without fever, general malaise saw MD 5/23/09. 6/1/09 Blood work showed low white blood cell count. Rash resolved now have flu like symptoms with partial recovery.				Y						05/21/2009	05/23/2009	2	Blood work 5/23/09 - result = low WBC presently.	PVT	PVT	SINGULAIR for asthma	None	Asthma			1						1	Influenza like illness; Malaise; Pruritus; Rash; Rash erythematous; White blood cell count decreased	FLU3~SANOFI PASTEUR~U2749AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB303DA~1~IM~LA~HEP A (HAVRIX)~1|TYP~SANOFI PASTEUR~B102613~1~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1|YF~SANOFI PASTEUR~UF630AA~1~SC~LA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0348639	06/07/2009	DE	1.0	1	.0	M	06/07/2009	Broke out in hives (10/19/07).  Developed a allergy to peanuts which had not been present prior to the immunization.   Long term adverse affect PDDnos.  8/7/09 MR rec'd from PCP.  Infor WCC 10/9/07 with normal exam, no concerns. 10/19/09 hives 2' to eating peanut butter.  DX:  urticaria.  Parental concern 10/14/08 re: not talking yet and rxn to PB.  Assess:  Speech and  Language delay. Failure to thrive dx on 1/22/09. Neurodevelopmental eval 5/2009 with dx:  PDD-Autism spectrum disorder.  .				Y				Y	N	10/10/2007	10/19/2007	9	Emergency room records from 10-19-07.  Pddnos diganose. 5-8-09. Labs and diagnostics:  audiology exam WNL. Cytogenetic testing WNL	UNK	UNK	none	No	unknown	Rash~Hep B (no brand name)~UN~0.10~Patient		1						1	Autism spectrum disorder; Food allergy; Urticaria	FLUX~UNKNOWN MANUFACTURER~UT2459NA~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~1255U~1~~~VARICELLA (VARIVAX)~1	USA	Disabling	Influenza
0348687	06/08/2009	HI	3.0	3		M	05/29/2009	Redness and induration at injection sites. Pain to touch at injection site.										05/27/2009	05/29/2009	2	NONE	PVT	PUB		NONE	NONE			1						1	Injection site erythema; Injection site induration; Injection site pain	DTAP~SANOFI PASTEUR~U247CA~UNK~UN~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~V2806AA~UNK~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB286AA~UNK~UN~LL~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~D23075~UNK~UN~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0348708	06/08/2009	MN	30.0	30		M	06/08/2009	Headache and diplopia accompanying a cerebellar hemorrhage occurring within about 24 hrs of an influenza vaccination.  7/31/09 Hospital records received DOS 11/15/08 to 11/18/08. Assessment: Cerebellar/extracerebellar hemorrhage, horizontal diplopia, possible Marfan's or other connective tissue disease. Patient presents as alert but somewhat slow. Somewhat dry mucous membranes. Slightly tachycardic. Bilateral hemispheric cerebellar hemorrhage. Left against medical advice. 9/29/09 ICD9 codes received for date of service 11/14/08 to 11/18/08.  ICD9 codes: V64.81, 228.02, 358.2, 378.85, V79.8, 692.9			Y	Y					Y	11/14/2008	11/15/2008	1	CT Head 11/Moderate amount of acute hemorrhage layering within superior sulci of both cerebellar hemispheres. No other evidence of intracranial hemorrhage. No definite mass or mass effect. Ventricles are normal in size. The etiology of this hemorrhage is indeterminate. The unusual location raises the possibility of an underlying vascular lesion or mass. MRI would be helpful for further evaluation. Exam is otherwise negative. MRI: 5.5 x 1.4 x 1.1 cm linear high T1/mixed T2/gradient echo hypointense signal c/w hemorrhage in superior cerebellum involves vermis and bilateral cerebellar hemispheres. Mild edema. No evidence of underlying mass or AVM. Small adjacent right cerebellar venous angioma (small cavernoma underlying the hemorrhage not excluded)MRV: No evidence of venous abnormality. MRA: Normal exam. 7/31/09 Hospital records received DOS 11/15/08 to 11/18/08. LABS and DIAGNOSTICS: CT Head - acute hemorrhage within superior sulci of both cerebellar hemispheres. MRI Head - abnormal c/w hemorrhage in superior cerebellum. CBC - Leukocytes 10.7 x10(9)/L (H) Neutrophils 8.9 x10(9)/L (H) Eosinophils 0.0 x10(9)/L (L). Prothrombin Time 11.3 s (H). CHEM - creatinine 0.7 mg/dL (L) Glucose 114 mg/dL (H).	UNK	UNK		Dermatitis	Possible Marfan. 7/31/09 Hospital records received DOS 11/15/08 to 11/18/08. Migraines with aura, sinusitis with headaches associated, nonspecific dermatitis. Possible Marfan syndrome, high-arched palate, shoulder subluxation and hyperlax finger joints. Nasoseptal deformity with obstruction. MRI shows slight ectasia of ascending thoracic aorta. Multiple dermal nevi - biospy demonstrated benign. Smoker. Head injury and concussion in 1988, knocked out. Contrast dye allergy.			1						1	Cerebellar haemorrhage; Computerised tomogram abnormal; Diplopia; Headache	FLUX~SANOFI PASTEUR~U2797BA~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening	Influenza
0348719	06/08/2009	CA	64.0	64		M	06/08/2009	Onset of head ache, nausea, bloating and diarrhea 2 days after taking last of four live virus oral typhoid vaccine capsules. Treatment not sought. Improving after 4 days of illness.									U	05/27/2009	06/04/2009	8	n/a	PUB	UNK	Lopid, Lotrel, and asprin.	none	hypertension			1						1	Abdominal distension; Diarrhoea; Headache; Nausea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA178AA(S)~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|TDAP~SANOFI PASTEUR~C2773BA~UNK~IM~LA~TDAP (ADACEL)~1|TYP~BERNA BIOTECH, LTD.~3001537~UNK~PO~MO~TYPHOID LIVE ORAL TY21A (VIVOTIF)~1	USA		Influenza
0337682	06/09/2009	OR	80.0	80		F	06/09/2009	Say her arm has remained sore for months after injection.				Y					U	09/30/2008	10/01/2008	1		MIL	OTH						1						2	Injected limb mobility decreased; Injection site pain; Myalgia; Pain in extremity; Sleep disorder; Pain in extremity	FLU3~SANOFI PASTEUR~U2771AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2771AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0348797	06/09/2009	CA	85.0	85		F	06/09/2009	85 y/o F NKA, PMH: Dementia, Hypertension, CVA,OA/DJD, hyperlipidemia  Patient also has h/o stroke. Patient was admitted for fracture following mechanical fall.                                                       ?  One day prior to discharge patient is given a flu shot. Within 20 minutes, patient developed acute changes in mental status.  Patient was slow to respond. Patient also had some finger numbness but patient had this symptom prior to receiving shot. Patient was negative for h/a, weakness, change in movements, no focal neurological deficit was observed. Patient did present some dyspnea, Xray did not reveal any cardiopulmonary disease. RR and O2 sat WNL.  ? Patient had received flu shots in the past w/o difficulty. ? Patient was transferred to monitored bed. Other possible reasons for sudden AMS: questionable sun-downing , pain ????   ? Other medications administered prior to flu shot: Roxanol 03:30, 08:45.  Percocet:06:00, 12:00, Saline flush:06:00, 16:00 ? Flu shot administered at 16:25 IM to left deltoid. (MFR:Glaxo SMK Lot:881175P									Y	02/19/2009	02/19/2009	0	see above	UNK	PUB	Roxanol, Percocet, Saline flush    for admin times please see ADE description	Please see PMH under ADE description	NKA			1						1	Condition aggravated; Depressed level of consciousness; Dyspnoea; Hypoaesthesia; Mental status changes; No reaction on previous exposure to drug; Oxygen saturation normal; X-ray normal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~881175P~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0348826	06/10/2009	IN	24.0	24		F	05/01/2009	None stated									Y	11/06/2008	11/06/2008	0		MIL	UNK		None	None			1						1	Unevaluable event	FLUX~SANOFI PASTEUR~500552P~1~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0348861	06/10/2009	MN	11.0	11		M	06/10/2009	Patient's mother reported patient had fevers and headache pain since immunizations on 12/15/2008. Patient had high fever and also seemed to be having hallucinations the night of 12/15/2008 in which he was running up and down stairs and swatting at things.  On Tuesday morning (12/16/2008), patient was taken by an ambulance to ER because his behavior was out of control per Mom. He had a rapid strep test done there, which was negative. Mom also reported one more brief episode on Tuesday night (12/16/2008) lasting only 3 minutes where patient seemed very afraid.				Y					Y	12/15/2008	12/15/2008	0		UNK	UNK		ADHD, Bunion	No Known Drug Alleriges			1						1	Abnormal behaviour; Fear; Hallucination; Headache; Pyrexia; Streptococcal identification test negative	FLU3~SANOFI PASTEUR~U2789CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2735AA~UNK~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~UF456CA~UNK~IM~LA~TDAP (BOOSTRIX)~1	USA	Emergency room visit	Influenza
0348872	06/10/2009	ND	59.0	59		F	06/09/2009	Pt had flu vaccine on 1-23-09. Since that date until present date pt c/o pain in rt deltoid area- no swelling, edema or temperature noted.									U	01/23/2009	01/23/2009	0	None as of 6/10/09.	PVT	OTH	PREMARIN;MVI; Calcium; ALAVERT; LYRICA; ALLEGRA; KENALOG im prn.	None	Environmental allergies; chronic OA; Menopausal			1						1	Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89685~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0348899	06/10/2009	VA	30.0	30		M	06/23/2005	Multiple medical conditions diagnosed since starting ANTHRAX vaccine series, including fatigue, reproducible arthralgias / myalgias, and obstructive lung disease Joint pain, multiple joints Start: 01/22/1999 back, knees, R shoulder, feet  Symptom: Fatigue, Malaise >60 Days Start: 01/22/1999 Symptom: Muscle Pain Start: 01/22/1999 Symptom: Dyspnea on exertion Start: 01/22/1999 Symptom: Erectile dysfunction Start: 01/22/1999 Symptom: Decreased libido (sexual drive) Start: 01/22/1999 Symptom: Dizziness Start: 01/22/1999 Symptom: Paresthesia Start: 01/22/1999 Symptom: Rash, focal Start: 09/08/2003 Comment: shingles Symptom: Dysphagia Start: 08/12/2002 Comment: heartbum Symptom: Chest Pain Start: 02/27/2002 Comment: atypical   6/17/09 Medical records received DOS 08/01 to 6/23/05. Patient presented with following problems related to the adverse event: cervicalgia, inhibited sexual excitement, Asthma, extrinsic w/o status asthmaticus, lumbago, chondromalacia patella, syndrome rotator cuff shoulder. The records provide a summary of services related to adverse event.				Y	Y			Y	N	01/22/1999			Diagnostic Tests: most recent: L spine MRI (9/03) L4/L5 stenosis R>L disc bulge; R knee MRI (10/02) chondromalacia with s effusion; R foot films (9/03) achilles/plantar spurs; + pes planus; + degenerative changes at 1st MTP; R shoulder MRI (10/02) SLAP tear supraspinatus tendinosis; UGI (8/02) + GERD; C spine MRI (8/02) C2/C3 foramen narrowing; + osteophytes; stress thallium (2/02) wnl; 2D echo (6/01) whl; EF-61%; PFT's (3/02) mild reversible obstruction; ST (6/02) + mult grasses/trees; Labs: CBC, CMP, hepatitis panel - wnl; gammaGT-213	MIL	MIL	Cyclobenzaprine 10 mg; Percocet-5/325; Elavil 10 mg; Albuterol 90 mcg; Prinivil 40 mg; Naprosyn 500 mg; Ultram 50 mg; Maxzide 50-75 mg; Docusate 100 mg; Saline NS 0.65%; Aciphex 20 mg; Doxycycline 100 mg; Advair 500-50 mcg; Lexapro 10 mg; C		None			1						1	Arthralgia; Cardiac stress test; Chest pain; Chronic obstructive pulmonary disease; Dizziness; Dyspepsia; Dysphagia; Dyspnoea exertional; Echocardiogram normal; Erectile dysfunction; Fatigue; Full blood count; Gamma-glutamyltransferase increased; Hepatitis viral test; Herpes zoster; Libido decreased; Malaise; Metabolic function test; Myalgia; Nuclear magnetic resonance imaging abnormal; Obstructive airways disorder; Paraesthesia; Pulmonary function test abnormal; Rash	ANTH~MICHIGAN DEPT PUB HLTH~FAV064~5~SC~UN~ANTHRAX (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~U0674AA~2~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0348902	06/10/2009	NC	35.0	35		F	11/09/2006	Patient received FLUMIST and ADACEL vaccines on 10/31. She developed severe arm pain and swelling in the left shoulder and arm a few hours after ADACEL vaccination. Symptom: Pain Start: 10/31/2006 Comment: In the left shoulder and left arm. Symptom: Erythema Start: 10/31/2006 Comment: At the left shoulder inoculation site. Symptom: Swelling Start: 10/31/2006 Comment: At the left shoulder inoculation site.				Y					Y	10/31/2006	10/31/2006	0	None	UNK	MIL	Multivitamins only		Allergies: CODEINE			1						1	Injection site erythema; Injection site swelling; Pain in extremity	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TDAP~SANOFI PASTEUR~C2559AA~UNK~UN~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0348904	06/10/2009	NC	33.0	33		F	11/03/2006	Symptom: Fever start: 10/31/2006 - Comment: Undocumented, no temperature taken. Symptom: Chills Start: 10/31/2003 - Comment: Have occurred 'off and on'; Symptom: Nausea w/vomiting - Start: 11/02/2006 - Comment: Patient vomited twice on 11/2, just feels mild nausea today; Symptom: Tenderness Start: 10/31/2006 - Comment: In the right deltoid and the right upper arm; Symptom: Numbness Start: 10/31/2006 - Comment: Patient reports vague 'numbness' in the right upper/arm; Symptom: Swelling Start: 10/31/2006 - Comment: Noted over the entire deltoid and spreading down the right arm but not below the distal bicep.										10/31/2006			None	UNK	UNK	None		NO birth defects; NKDA; No medical conditions.			1						1	Chills; Injection site anaesthesia; Injection site swelling; Nausea; Pain in extremity; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TDAP~SANOFI PASTEUR~C2556AA~UNK~~RA~TDAP (ADACEL)~1	USA		Influenza
0348928	06/11/2009	MI	51.0	51		M	10/10/2008	Fever 103 degree and rigor 12 hours after injection - Resolved 12 hours later without treatment.									Y	10/03/2008	10/03/2008	0	None	PVT	PVT	None	None	None			1						1	Chills; Pyrexia	FLU3~SANOFI PASTEUR~02755AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0348932	06/11/2009	PA	17.0	17		M	06/05/2009	Varicella vaccine breakthrough. Diagnosed with varicella in office today.									U	10/16/2008	06/02/2009	229		PVT	PVT	ZYRTEC; ADVAIR; PROVENTIL	None	Asthma			1						1	Varicella post vaccine	FLU3~SANOFI PASTEUR~U2754AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~UF455BA~1~IM~RA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~1135X~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0348978	06/11/2009	CA	47.0	42		U		Not recently, but want to report now. 3 Influenza vac, with identical reactions each time of visual change (marked) & headache. Recovered all 3 times within 6-8 hours.									Y	11/01/2004	11/01/2004	0	No	PUB	UNK						1						1	Headache; Vaccine positive rechallenge; Visual impairment	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0344399	06/15/2009		64.0			M	06/12/2009	Report obtained from literature case report. A 64 year old male patient (Initials and Date of Birth unknown) received the influenza vaccine on an unknown date. Brand and batch number is unknown. The patient had a medical history of atrial fibrillation, chronic obstructive pulmonary disease, hypercholesterolaemia, type 2 diabetes mellitus, depression, hypertension and gastroesophageal reflux disease. Concomitant medications included warfarin 5mg every other day alternating with 2.5mg, celecoxib 200mg as needed for pain, ipratropium/albertol combination with dose of 2 puffs twice daily, diltiazem 120mg twice daily, metformin 500mg twice daily, hydrochlorothiazide/losartan combination 25mg/100mg daily, escitalopram 20mg daily, lansoprazole 30mg daily, propranolol 40mg twice daily and ezetimibe/simvastatin 10mg/40mg daily. All medication regimens were unchanged for at least 6 months. At the time of vaccination the patient had an INR (international normalised ratio) value of 2.0. The patient has previously received influenza vaccine during warfarin therapy with no complications. In the previous year, the patient's INR was 2.4 on the day of influenza vaccination with a follow-up INR of 3.0 7 weeks later. On an unknown date, 4.5 weeks after the patient received the influenza vaccine, the patient presented to the emergency department and was unresponsive for approximately 1 hour. The patient had rectal bleeding over the previous 2 days prior to admission. The INR value at admission was greater than 15. INR values over the previous 6 months were relatively stable. Refer to attached literature article for INR values. Investigations revealed the following results. Presenting haemoglobin was 8.3g/dL (14-18), hematocrit 24% (42-52) and platelet values 412 X 10 (3) (150-430). Additional laboratory data included a low serum albumin of 3.1g/dL (3.5-5.0) and normal measures for total bilirubin of 0.8mg/dL (0.2-1.0), aspartate aminotransferase of 16 IU/L (10-42), alanine aminotransferase 12 IU/L (10-40). Vital signs included blood pressure 166/60 mmHg, heart rate of 62 beats per minute, respiratory rate of 16 breaths per minute. A noncontrast CT scan of the head revealed a large parenchymal haemorrhagic infarction involving the left temporal, parietal and occipital lobes. There was a significant mass effect including 12mm rightward midline shift and impending uncal herniation. Treatment included a nitroglycerin infusion to maintain systolic blood pressure and infusion of 4 units of fresh frozen plasma and 10mg of Vitamin K. The patient died 17 hours after admission. This case is reported as serious due to death of patient. The company considered events as unlikely in regards to the interaction between the influenza vaccine and warfarin. The time between FLUVAX administration and the patient presenting to hospital with symptoms was 4.5 weeks. It must be noted, however, that the patient tolerated the vaccine in the past whilst concomitantly taking warfarin and there is the possibility of multiple interacting medications. Information derived from this AE report does not change the current safety profile of the product.	Y				Y	0			N				Alanine Aminotransferase, 12 IU/L, Normal; Aspartate Aminotransferase, 16 IU/L, Normal; Haematocrit, 24%, Depressed; Haemoglobin, 8.3 g/dL, Depressed; Platelets, 412x10(3) uL, Normal; Serum Albumin, 3.1 g/dL, Depressed; Total Bilirubin, 0.8 mg/dL, Normal	OTH	OTH			Atrial fibrillation; Chronic Obstructive Pulmonary Disease; Hypercholesterolaemia; Type 2 diabetes mellitus; Depression; Hypertension; Gastroesophageal reflux disease		2009020308	1						4	Cerebral infarction; Computerised tomogram abnormal; Death; Haemorrhage intracranial; International normalised ratio fluctuation; Rectal haemorrhage; Unresponsive to stimuli; Alanine aminotransferase normal; Aspartate aminotransferase normal; Blood albumin decreased; Blood bilirubin normal; Blood product transfusion; Brain herniation; Brain mass; Computerised tomogram abnormal; Death; Haematocrit decreased; Haemoglobin decreased; Haemorrhagic infarction; International normalised ratio increased; Platelet count normal; Rectal haemorrhage; Unresponsive to stimuli; Alanine aminotransferase normal; Aspartate aminotransferase normal; Blood albumin decreased; Blood bilirubin normal; Blood product transfusion; Computerised tomogram abnormal; Computerised tomogram head; Death; Haematocrit decreased; Haemoglobin decreased; Haemorrhagic cerebral infarction; Heart rate normal; International normalised ratio increased; Platelet count normal; Rectal haemorrhage; Respiratory rate; Unresponsive to stimuli; Alanine aminotransferase normal; Aspartate aminotransferase normal; Blood albumin decreased; Blood bilirubin normal; Blood product transfusion; Cerebral infarction; Computerised tomogram abnormal; Death; Haematocrit decreased; Haemoglobin decreased; Haemorrhagic infarction; International normalised ratio increased; Platelet count normal; Rectal haemorrhage; Unresponsive to stimuli	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|FLU3~CSL LIMITED~~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~4	USA	Results in Death	Influenza
0349096	06/15/2009	KS	62.0	62		F	06/15/2009	3010/29 Itching under armpits 10/30 red and itchy under arms, down side of breasts, on stomach and down to the pelvic area. 10/31 went to stat care saw 2 Dr.s sent her to Dr. Advised prob. reaction to flu shot. Gave predisone and itch med. Had Hx. of hives from boiled eggs when 2yrs eats eggs now and has had flu shot for 10 years without problems.				Y					Y	10/27/2008	10/30/2008	3		UNK	UNK						1						1	Erythema; Pruritus	FLU3~SANOFI PASTEUR~U2810AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0349106	06/15/2009	MN	13.0	13		F	06/15/2009	Fainting spells started in January 2009. They occurred multiple times per day and continued for over 2 months. She also experienced nausea, dizziness and was lightheaded. She also suffered from fatigue, weakness, stomach aches and muscle and joint pain. She was unable to attend school for an extended period of time.				Y					N	11/04/2008	01/09/2009	66		PVT	PVT		none	infection induced asthma, sulfa allergy			1						1	Abdominal pain upper; Activities of daily living impaired; Arthralgia; Asthenia; Dizziness; Fatigue; Myalgia; Nausea; Syncope	FLUX~UNKNOWN MANUFACTURER~unknown~7+~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0349239	06/16/2009	AL	47.0	47		M	06/08/2009	None stated										06/08/2009				UNK	UNK						1						1	No adverse event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA173AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0349263	06/16/2009	CO	15.0	15		M	06/16/2009	3/29/2009 Was hospitalized with meningococcal meningitis and bacteremia.  6/24/09 Hospital ER records received DOS 3/29/09. Assessment: Meningitis, diabetes. Patient presents with worsening headache, stiff neck, photophobia, fever, malaise, nausea and vomiting. Petechial rash, purpura both ankles. Transfered to higher level facility.  6/18/09 ICD-9 codes received. 3209, 25001, V5567, 78060  7/8/09 Hospital records received DOS 3/29/09 to 4/1/09. Assessment: Neisseria meningitidis meninigitis, insulin dependent diabetes. Patient presented with 24 hour fever, nuchal rigidity, and rash with petechia and purpuric lesions on all extremities. Vomiting, minimal oral intake. Tachycardia. Thin, dehydrated, and poorly perfused. Lips dry. Warm, flushed, pink. Myalgia, chills.					Y	3			Y	10/12/2007	03/28/2009	533	Blood and CSF specimens collected 3/29/2009 were culture positive for Neisseria meningitidis serogroup C.  6/24/09 Hospital ER records received DOS 3/29/09. LABS and DIAGNOSTICS: Lumbar puncture. CSF - Cloudy, WBC 1860 /uL (H) RBC 150 /uL(H) Neutrophils 100% (H) Glucose 138 mg/dL (H) Protein Total 308 mg/dL (H). CBC - WBC 15.5 1000/uL (H) Neutrophils 13.4 1000/uL (H) Neutrophils 87% (H) Lymphocytes 8% (L). CHEM - Sodium 133 mmol/L (L) Glucose 288 mg/dL (H).  Blood Gram Stain - positive for Neisseria meningitidis. CSF Gram Stain - Many PMN's, no organisms seen. CSF Culture - positive for Neisseria meningitidis. CT Head - Normal. Chest X-Ray - WNL. 7/8/09 Hospital records received DOS 3/29/09 to 4/1/09. LABS and DIAGNOSTICS: CSF Culture (+). CSF - 1800 WBC's 100% segs, protein 308, glucose 138. CBC - WBC 15.9 X10 9/L (H) RBC 4.29 X10 12/L (L) HGB 12.7 gm/dL (L) HCT 38.2% (L) PLT 125 X10 9/L (L) NE# 14.90 X10 9/L (H) Lymph# 0.42 X10 9/L (L). CHEM - CO2 31 mmol/L (L) GLU 175 mg/dL (H) ALB 3.4 g/dL (L) BILI TOT 0.1 mg/dL (L). CRP 26.2 mg/dL (H). Coagulation Studies - abnormal.	UNK	UNK	Insulin		Diabetes mellitus. 7/8/09 Hospital records received DOS 3/29/09 to 4/1/09. Insulin-dependent diabetes, mononucleosis, fractured tibia.			1						1	Bacteraemia; Blood culture positive; CSF culture positive; Meningitis meningococcal	FLU3~SANOFI PASTEUR~U2437AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB182AA~2~IM~LA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2330AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Hospitalisation	Influenza
0349275	06/16/2009	PA	8.0	8		M	06/16/2009	Right Arm reddened, swollen and painful some itchy. Mother stated notice swelling last evening 6/16/09 at about 8.00pm. Mother did not massage arm after shot.				Y					Y	06/15/2009	06/15/2009	0		UNK	UNK						1						1	Erythema; Oedema peripheral; Pain in extremity; Pruritus	FLU3~SANOFI PASTEUR~U2898PA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~AHAVB256BA~2~IM~LA~HEP A (VAQTA)~1|VARCEL~MERCK & CO. INC.~0263Y~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0210764	06/17/2009		0.8			U	06/17/2009	We received the following literature report: In 2002 with the documentation of the sizeable burden of influenza in children 6-23 months of age, the committee encouraged children in this age group to received trivalent influenza vaccination (TIV). To assess TIV vaccine safety, analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following smallpox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1439 to MA2009-1443, MA2009-1445 and MA2009-1447 to MA2009-1454). This case refers to a 9.6-month-old patient that was found dead in crib one day after influenza vaccination (manufacturer and batch no. unknown). Vaccine received with TIV: SYNAGIS. Medical history: Chronic lung disease, microcephaly, developmental delay. No autopsy had been done.	Y								N					OTH	OTH	SYNAGIS	Chronic lung disease; Microcephaly; Developmental Delay			MA20091438	1						2	Death	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Results in Death	Influenza
0211721	06/17/2009		1.3			U	06/17/2009	We received the following literature report: In 2002 with the documentation of a sizeable burden of influenza in children 6-23 months of age, the committee encouraged children in this age group to receive trivalent influenza vaccination TIV. To assess TIV vaccine safety, the committee and co-workers analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess the cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following smallpox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1438, MA2009-1440 to MA2009-1443, MA2009-1445 and MA2009-1447 to MA2009-1454). This case refers to a 15-month-old patient who developed fever, respiratory distress and shock one day after influenza vaccination (batch no. and manufacturer unknown). Vaccine received with TIV: DTaP/HIB. Medical history: Polycystic kidney disease, hypertension. Autopsy results: Pseudomonas sepsis and possible liver cyst/cholangitis.	Y								N					OTH	OTH		Polycystic kidney disease; Hypertension			MA20091439	1						2	Autopsy; Death; Pseudomonal sepsis; Pyrexia; Respiratory distress; Shock	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HIBV~UNKNOWN MANUFACTURER~~UNK~UN~UN~HIB (NO BRAND NAME)~2	USA	Results in Death	Influenza
0213215	06/17/2009		0.5			U	06/17/2009	We received the following literature report: In 2002 with the documentation of a sizeable burden of influenza in children 6-23 months of age, the committee encouraged children in this age group to receive TIV. To assess TIV vaccine safety, the committee and co-workers analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess the cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following smallpox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1438 to MA2009-1443 and MA2009-1447 to MA2009-1454). This case refers to a 6-month-old patient who was found dead in crib one day after influenza vaccination (batch no. and manufacturer unknown). Autopsy result: sudden infant death syndrome. Vaccine received with TIV: DTaP/IPV/PCV.	Y								N					OTH	OTH	No other medications	Unknown			MA20091445	1						2	Autopsy; Sudden infant death syndrome	DTAP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~DTAP (INFANRIX)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|IPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~2	USA	Results in Death	Influenza
0214136	06/17/2009		1.7			U	06/17/2009	We received the following literature report: In 2002 with the documentation of a sizeable burden of influenza in children 6-23 months of age, the committee encouraged children in this age group to receive TIV. To assess TIV vaccine safety, the committee and co-workers analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess the cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following smallpox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1438 to MA2009-1440, MA2009-1442, MA2009-1443, MA2009-1445 and MA2009-1447 to MA2009-1454). This case refers to a 20-month-old patient who was found with vomiting in crib and developed aspiration pneumonia five days after influenza vaccination (batch no. and manufacturer unknown). Medical history: Chronic lung disease, gastroesophageal reflux, grade II intraventricular hemorrhage, cerebral palsy. Autopsy results: aspiration pneumonia.	Y								N					OTH	OTH	No other medications	Chronic lung disease; Gastroesophageal reflux; Grade II intraventricular hemorrhage	Cerebral palsy		MA20091441	1						2	Autopsy; Death; Pneumonia aspiration; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Results in Death	Influenza
0228504	06/17/2009		0.5			U	06/17/2009	We received the following literature report: In 2002 with the documentation of a sizeable burden of influenza in children 6-23 months of age, the committee encouraged children in this age group to receive TIV. To assess TIV vaccine safety, the committee and co-workers analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess the cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following smallpox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1438, MA2009-1439, MA2009-1441 to MA2009-1443, MA2009-1445 and MA2009-1447 to MA2009-1454). This case refers to a 6-month-old patient who was found dead in crib one day after influenza vaccination (batch no. and manufacturer unknown). Vaccine received with TIV: DTaP/IPV/PCV. Medical history: Joubert syndrome with apneic episodes. Autopsy results: Inconclusive.	Y								N					OTH	OTH		JOUBERT syndrome with apneic episodes			MA20091440	1						2	Autopsy; Death	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|IPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~2	USA	Results in Death	Influenza
0228987	06/17/2009		0.8			U	06/17/2009	We received the following literature report: In 2002 with the documentation of a sizeable burden of influenza in children 6-23 months of age, committee encouraged children in this age group to receive TIV. To assess TIV vaccine safety, the committee and co-workers analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess the cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following smallpox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1438 to MA2009-1441, MA2009-1443, MA2009-1445 and MA2009-1447 to MA2009-1454). This case refers to a 10-month-old patient who developed fever after influenza vaccination (batch no. and manufacturer unknown) that progressed over 4 days to gastrointestinal illness, rash, seizure and respiratory distress. The patient died five days after vaccination.	Y								N					OTH	OTH	No other medications	Skeleton Dysplasia; Dwarfism			MA20091442	1						2	Convulsion; Death; Gastrointestinal disorder; Pyrexia; Rash; Respiratory distress	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Results in Death	Influenza
0232179	06/17/2009		1.5			U	06/17/2009	We received the following literature report: In 2002 with the documentation of a sizeable burden of influenza in children 6-23 months of age, the committee encouraged children in this age group to receive TIV. To assess TIV vaccine safety, the committee and co-workers analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess the cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following smallpox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1438 to MA2009-1443, MA2009-1445, MA2009-1447 to MA2009-1451 and MA2009-1453 to MA2009-1454). This case refers to a 18-month-old patient who was unresponsive in crib six days after influenza vaccination (batch no. and manufacturer unknown). Autopsy results: bronchopneumonia probably of bacterial origin.	Y								N					OTH	OTH	No other medications	Unknown			MA20091452	1						3	Autopsy; Bronchopneumonia; Unresponsive to stimuli	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~3	USA	Results in Death	Influenza
0232509	06/17/2009		0.5			U	06/17/2009	We received the following literature report: In 2002 with the documentation of a sizeable burden of influenza in children 6-23 months of age, the committee encouraged children in this age group to receive TIV. To assess TIV vaccine safety, the committee and co-workers analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess the cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following smallpox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1438 to MA2009-1443, MA2009-1445 and MA2009-1448 to MA2009-1454). This case refers to a 6-month-old patient who developed fever and irritability seven days as well as seizures 14 days after influenza vaccination (batch no. and manufacturer unknown). Patient lost all physical abilities and died 22 months after influenza vaccination. Vaccines received with TIV: DTaP. Autopsy results: diagnosed with white matter disease, gene mutation found.	Y								N					OTH	OTH	No other medications	Unknown			MA20091447	1						2	Autopsy; Convulsion; Death; Gene mutation; Irritability; Physical disability; Pyrexia	DTAP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~DTAP (INFANRIX)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Results in Death	Influenza
0233373	06/17/2009		1.0			U	06/17/2009	We received the following literature report: In 2002 with the documentation of the sizeable burden of influenza in children 6-23 months of age, the committee encouraged children in this age group to received trivalent influenza vaccination (TIV). To assess TIV vaccine safety, analyzed all of the adverse events reported to the Vaccine Adverse Event Reporting System after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following small pox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1438 to MA2009-1443, MA2009-1445 and MA2009-1447 to MA2009-1454). This case refers to a 12-month-old patient who developed cardiorespiratory arrest two days after influenza vaccination (batch no. and manufacturer unknown). Vaccines received with TIV: varicella vaccine, MMR vaccine. Autopsy results: etiology is undetermined, patient had recent cold symptoms.	Y								N					OTH	OTH	No other medications	Unknown	Recent cold symptoms		MA20091448	1						2	Autopsy; Cardio-respiratory arrest; Death	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|MMR~UNKNOWN MANUFACTURER~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~2|VARCEL~UNKNOWN MANUFACTURER~~UNK~UN~UN~VARICELLA (NO BRAND NAME)~2	USA	Results in Death	Influenza
0246080	06/17/2009		1.2			U	06/17/2009	We received the following literature report: In 2002 with the documentation of a sizeable burden of influenza in children 6-23 months of age, the committee encouraged children in this age group to receive TIV. To assess TIV vaccine safety, the committee and co-workers analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess the cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following smallpox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1438 to MA2009-1443, MA2009-1445, MA2009-1447 to MA2009-1448 and MA2009-1450 to MA2009-1454). This case refers to a 14-month-old patient who was found dead in a crib two days after influenza vaccination (batch no. and manufacturer unknown). Autopsy results: Death ruled undetermined, pathology with chronic bronchitis, sick contact with parainfluenza.	Y								N					OTH	OTH	No other medications	Bronchitis Chronic			MA20091449	1						2	Autopsy; Death	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Results in Death	Influenza
0248538	06/17/2009		1.1			U	06/17/2009	We received the following literature report: In 2002 with the documentation of the sizeable burden of influenza in children 6-23 months of age, the committee encouraged children in this age group to received trivalent influenza vaccination (TIV). To assess TIV vaccine safety, co-workers analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following smallpox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1438 to MA2009-1443, MA2009-1445, MA2009-1447 to MA2008-1449 and MA2009-1451 to MA2009-1454). This case refers to a 13-month-old patient who developed upper respiratory symptoms that lead to apnea and death one day after influenza vaccination (batch no. and manufacturer unknown). Autopsy results: not provided. Vaccines received with TIV: HIB/Varicella/MMR.	Y								N					OTH	OTH	No other medications	Unknown			MA20091450	1						3	Apnoea; Autopsy; Death; Respiratory disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|HIBV~UNKNOWN MANUFACTURER~~UNK~UN~UN~HIB (NO BRAND NAME)~3|MMR~UNKNOWN MANUFACTURER~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~3|VARCEL~UNKNOWN MANUFACTURER~~UNK~UN~UN~VARICELLA (NO BRAND NAME)~3	USA	Results in Death	Influenza
0249021	06/17/2009		1.1			U	06/17/2009	We received the following literature report: In 2002 with the documentation of a sizeable burden of influenza in children 6-23 months of age, the committee encouraged children in this age group to receive TIV. To assess TIV vaccine safety, the committee and co-workers analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess the cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following smallpox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1438 to MA2009-1442, MA2009-1445 and MA2009-1447 to MA2009-1454). This case refers to a 13-month-old patient who developed heart failure seven days after influenza vaccination (batch no. and manufacturer unknown). Vaccines received with TIV: HIB/PCV. Autopsy results: myocarditis.	Y								N					OTH	OTH	No other medications	Asthma			MA20091443	1						2	Autopsy; Cardiac failure; Death; Myocarditis	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~2|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~2	USA	Results in Death	Influenza
0249821	06/17/2009		1.6			U	06/17/2009	We received the following literature report: In 2002 with the documentation of the sizeable burden of influenza in children 6-23 months of age, the Advisory Committee encouraged children in this age group to receive trivalent influenza vaccination (TIV). To assess TIV vaccine safety, author and co-workers analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following smallpox vaccination, the pathological findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer to cases MA2009-1438 to MA2009-1443, MA2009-1445, MA2009-1447 to MA2009-1450 and MA2009-1452 to MA2009-1454). This case refers to a 19-month-old patient who was found dead in crib one day after influenza vaccination (batch no. and manufacturer unknown). Medical history: bronchitis 10 days prior to vaccination. Autopsy results: none available.	Y								N					OTH	OTH	No other medications	Unknown	Bronchitis 10 days prior to vaccination		MA20091451	1						2	Autopsy; Death	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Results in Death	Influenza
0250504	06/17/2009		1.0			U	06/17/2009	We received the following literature report: In 2002 with the documentation of the sizeable burden of influenza in children 6-23 months of age, the committee encouraged children in this age group to received trivalent influenza vaccination (TIV). To assess TIV vaccine safety, co-workers analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following small pox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1438 to MA2009-1443, MA2009-1445, MA2009-1447 to MA2009-1452 and MA2009-1454). This case refers to a 12-month-old patient who developed mild upper respiratory symptoms, fever and fussy five days after influenza vaccination (batch no. and manufacturer unknown) and died (unexpected). Vaccines received with TIV: Varicella/MMR. Autopsy results: natural causes.	Y								N					OTH	OTH	No other medications	Unknown			MA20091453	1						4	Autopsy; Death; Irritability; Pyrexia; Respiratory disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~4|MMR~UNKNOWN MANUFACTURER~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~4|VARCEL~UNKNOWN MANUFACTURER~~UNK~UN~UN~VARICELLA (NO BRAND NAME)~4	USA	Results in Death	Influenza
0258294	06/17/2009		1.9			U	06/17/2009	We received the following literature report: In 2002 with the documentation of the sizeable burden of influenza in children 6-23 months of age, the committee encouraged children in this age group to received trivalent influenza vaccination (TIV). To assess TIV vaccine safety, co-workers analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following smallpox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primary reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1438 to MA2009-1443, MA2009-1445 and MA2009-1447 to MA2009-1453). This case refers to a 23-month-old patient who developed low-grade fever, cranky, gastrointestinal illness, and ulcers on lower lip seven days after influenza vaccination (batch no. and manufacturer unknown). The patient died one week after vaccination. Autopsy results: complications from viral infections. Cultures negative. Pathology of brain: focal perivascular chronic inflammation combined with viral encephalopathy/brain edema. Lung pathology: minimal edema and minimal acute and chronic inflammation.	Y								N					OTH	OTH	No other medications	Unknown			MA20091454	1						2	Autopsy; Brain oedema; Culture negative; Death; Encephalopathy; Gastrointestinal disorder; Irritability; Lip ulceration; Pathology test; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Results in Death	Influenza
0349361	06/17/2009	AZ	63.0	63		F	06/15/2009	GBS - numbness, tingling, burning of feet, progressing to calves and near knees. 8 days hospitalization. Immunoglobulin - 5 days.   7/13/09 Hospital records received DOS 12/26/09 to 1/3/09. Assessment: Atypical Guillain Barre Syndrome. Following several days of diarrhea and nausea, the patient presented with bilateral lower extremity weakness and, preceded by numbness, burning sensation and tingling in legs. Several falls injuring knee and twisting ankles. Swelling of right lower extremity. Absent reflexes at ankles, diminished at knees. Intially tachycardic and hypoxic. Left lower lobe pulmonary emboli. Developed progressive weakness and was unable to walk. Septic from urinary tract infection. IVIG.  ICD-9 codes: 357.0, 415.19, 276.1, 401.9, 272.4, 300.00, V12.54, 733.90, 253.8   7/22/09 Received Neuro medical records of 12/2008- FINAL DX: idiopathic polyneuropathy, Guillain Barre syndrome Records reveal patient experienced fever w/thoracic rash, diarrhea, weakness, difficulty walking, several falls w/leg injuries & swelling, excessive sleepiness s/p cruise ship travel.  Initial exam revealed absent ankle reflexes, swollen ankles bilaterally, right calf swelling, ataxia, bilateral weak dorsiflexion & intermittent pain.  Follow up visits s/p hospitalization for AIDP tx w/IVIG reveal patient w/continued leg weakness, bilateral foot drop, s/p PE & on coumadin. Recent fall at home w/burn injury; continuing PT.			Y	Y	Y	8		Y	N	09/27/2008	12/06/2008	70	GUILLAIN BARRE syndrome. 7/13/09 Hospital records received DOS 12/26/09 to 1/3/09. LABS and DIAGNOSTICS: EMG - abnormal, axonal damage and demyelination. CSF - lymphocytes and monocytes, red blood cells, negative for malignancy. Urine Culture - E. coli (+). INR 1.3 (H). CHEM - Sodium 128 mmol/L (L) Chloride 94 mmol/L (L) Glucose 129 mg/dL (H) Calcium 7.4 mg/dL (L) Total Protein 5.5 g/dL (L) Albumin 2.6 g/dL (L) AST 38 U/L (H) ALT 37 U/L (H). Hgb A1c 5.9% (H). Sed rate 37 mm/HR (H). TIBC 134 ug/dL (L). Iron 10 ug/dL (L) Ferritin 409.5 ug/L (H). CBC - HGB 11.9 g/dL (L) HCT 34.0% (L) MPV 7.6 fL (L) Neutro 84.1% (H) Lymph 3.8% (L) Mono 11.3% (H) Abs Neutro 9.2 X 10^3/mm^3 (H) Abs Lymph 0.4 X 10^3/mm^3 (L) Abs Mono -1.2 X 10^3/mm^3 (H). CT Chest Abdomen and Pelvis: Abnormal, pulmonary emboli, pericardial effusion, diverticulosis, atherosclerosis, atelectasis. Chest X-Ray - Abnormal, pulmonary emboli, pleural effusions. MRI Brain - Non-specific findings. MRI Cervical Spine - Degenerative disc disease. MRI Lumbar Spine - Degenerative disc disease. MRI Thoracic Spine - Degenerative disc disease. Abdominal Ultrasound - mass left kidney.   7/22/09 Neuro consult records received LABS: EMG/NCS abnormal & c/w axonal & demyelinating polyneuropathy.	OTH	PVT	Lisinopril; Lovastatin	None	7/13/09 Hospital records received DOS 12/26/09 to 1/3/09. Hypertension, Dyslipidemia, TIA, Anxiety disorder, lower extremity spasms. Hysterectomy.  7/22/09 Neuro consult records received PMH: migraine HAs, HTN, hyperlipidemia, CTS.  Allergy: PCN.  Family hx: daughter w/MS; heart disease, cancer, migraines, Parkinson's.			1						1	Blood product transfusion; Burning sensation; Guillain-Barre syndrome; Hypoaesthesia; Paraesthesia; Abasia; Fall; Guillain-Barre syndrome; Hypoaesthesia; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA181~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0349416	06/17/2009	NC	18.0	18		M	02/08/2005	12/13/86 - received spv, yellow fever, typhoid, and flu vaccines. On that day after the vaccinations, gradually started to feel exhausted and weak - had the onset of progressive n/v, inability to swallow, and fever (temp not taken) - also developed rapid onset of swelling to the left upper arm (where the spv was given) along with rash (initially noticed on chest, pt. does not remember if pruritic) - rashes spread to bilat arms (majority on chest) - looked like mosquito bites - above sxs worsened. 12/14/86 - went to ER - was initially dx'ed with cellulitis from the site of immunization - was admitted (r/o sepsis) for the following 4 wks - positive staph and increased cold agglutinins titer (doubled from 1:32 to 1:512) - above successfully treated with IV antibiotics - dx at clc bacteremia secondary to staph secondary to possible Inoculation Immunization - echo no evidence of vegetation.  6/23/09 Medical records received DOS 12/13/86 to 2/4/05. Assessment: Sepsis with diffused rash temporally associated with receipt of vaccines. Patient presented feeling exhaused and weak. Nausea, vomiting, inability to swallow, fever, swelling of left upper arm (site of smallpox vaccine), rash on chest and arms. Cellulitis from site of immunization. Bacteremia staph secondary to possible innoculation immunization. IV antibiotics. ICD-9 codes: 401.9, 780.7, 782.1, 790.7					Y	29	Y			12/13/1986	12/13/1986	0	Diagnostic Tests: Request for med records sent; Labs: Request for med records sent.  6/23/09 Medical records received DOS 12/13/86 to 2/4/05. LABS and DIAGNOSTICS: Staph (+). Cold Agglutinins Titer - doubled. Echocardiogram (-).	MIL	MIL	None		Denies			1						1	Asthenia; Bacteraemia; Cold agglutinins positive; Dysphagia; Dysphagia; Echocardiogram normal; Fatigue; Injection site cellulitis; Injection site swelling; Laboratory test; Nausea; Pyrexia; Rash; Rash; Staphylococcal infection; Vaccination complication; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~UNKNOWN MANUFACTURER~~UNK~ID~UN~SMALLPOX (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~SC~UN~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1|YF~UNKNOWN MANUFACTURER~~UNK~SC~UN~YELLOW FEVER (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0349429	06/17/2009	CA	53.0	53		M	06/17/2009	Body ache, fever, right hand swelling, arm, leg pain.				Y					N	06/12/2009	06/13/2009	1		UNK	PUB	None	None	NKDA			1						1	Oedema peripheral; Pain; Pain in extremity; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~366CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0349430	06/17/2009	NC	39.0	39		M	02/22/2005	Description: 1/21/05- received primary FLUMIST- no problems. 1/23/05- felt run down. 1/24/05- c/o n/v, diarrhea, fever (temp not taken), chills and night sweats- was seen by PCM- states no diagnosis given- received quarters x2 days. 1/26/05- above sxs improved- started to notice back pain- felt like I pulled my muscle in the middle of my back- woke up at midnight with severe chest pain (pressure-like, sharp and dull, 9/10), left arm numbness, worsening back pain, and dyspnea- alleviated by sitting- aggravated by lying down- pain similar to pericarditis he had 2 years ago- no c/o f/c, malaise, fatigue, n/v or diaphoresis. 1/27/05- went to ER- was admitted to medical center- over two days, telemetry was at NSR- given dx of acute pericarditis. 1/28/05- was discharged in stable condition with INDOCIN 25mg 1 tab TID x2 wks- f/u scheduled with clinic in 1 week with his PCM- states still had intermittent cp and dyspnea (3/10) at rest at discharge- other sxs resolved. 2/2/05- pt. seen by his Case Manager- states currently has no cp or dyspnea at rest- however still experiences mild (2/10) cp and dyspnea with excessive talking or with increased physical activities. Pt. has a h/o acute pericarditis 2 years ago- pt. unsure if sxs appeared before or after receiving a flu vaccine- was hospitalized- sxs completely dissipated- no reoccurrence of sxs until recent episode. Discussed case via phone with pt's PCM, algorithm review- f/u cardiology referral recommended. Symptom: Flu-like symptoms< 96 hours Start: 01/23/2005 End: 01/26/2005. Symptom: Chest Pain Start: 01/26/2005 Comment: Initial (9/10, at rest), Present (1/10, with increased activity). Symptom: Dyspnea (shortness of breath) Start: 01/16/2005 Comment: Initial (9/10, at rest), Present (2/10, with increased activity). Symptom: Muscle Pain Start: 01/26/2005 End: 01/28/2005 Comment: Back pain.  6/23/09 Medical records recieved DOS 1/21/05 to 2/22/05. Assessment: Acute pericarditis. Records received support previously submitted information. No additional coding.  ICD-9 Codes: 420.90, 786.0, 786.5, 722.52, 477.0					Y	2			U	01/21/2005	01/23/2005	2	Diagnostic Tests: 1/27/05 Echo: Normal LV systolic function with EF 65%; Small anteriorly located pericardial effusion no hemodynamic compromise; Normal chamber size; Grossly normal appearing valvular structures; Mild tricuspid regurgitation; EKG: Notable for elevated ST segments in most leads; CXR: No evidence of focal lung disease but very low lung volumes are present and possibly some bibasilar atelectasis.  Additionally the cardiac silhouette is large in size.; Labs: 1/27/05 (08:29) CK= 109 (22-269); Troponin = <0.010 (0.00-0.029); CRP= 3.6 H (0.0-2.2); 1/27/05 (07:13) CK= 112 (22-269); Troponin =< 0.010 (0.00-0.029); CRP= 3.6 H (0.0 - 2.2); 1/27/05 (02:13) CKMB= 2.3 (0-6.73); Troponin <0.010 (0.00-0.029); Fibrin D= 0.3 (0.0-0.4); Flu A/B AG= negative; CBC with diff- HCT= 37.5 (39-52) o/w all WNL; K=3.4 L (3.6-5.); Ca= 8.7 L (9.0 -10.5); Anion gap= 7 L (10-20) o/w lytes all WNL	UNK	UNK	MOTRIN 800 mg PRN		Allergic rhinitis- 1991			1						1	Anion gap decreased; Back pain; Blood calcium decreased; Blood creatine phosphokinase MB; Blood creatine phosphokinase normal; Blood potassium decreased; C-reactive protein increased; Chest X-ray abnormal; Chest pain; Chills; Diarrhoea; Differential white blood cell count; Dyspnoea; Echocardiogram normal; Electrocardiogram abnormal; Fatigue; Feeling abnormal; Fibrin D dimer normal; Full blood count; Haematocrit decreased; Hypoaesthesia; Influenza like illness; Influenza serology negative; Nausea; Night sweats; Pericarditis; Pyrexia; Troponin; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0349447	06/17/2009	CT	24.0	21		F	04/15/2005	Description: 2/3/05- received SPV (3 pokes, left upper arm) along with flu vaccine (right upper arm)- states was getting over a cold (only sx= nasal congestion- sx resolved within next two days). 2/8/05- noticed sudden sharp (knife-stabbing) pain that ran down left side of my head down to my left jaw- no aggravating or alleviating factors- sx lasts few seconds- occurs every minute- no meds taken for sxs- no other systemic complaints. 2/9/05- states started to notice left side of her lips and chin numb and swollen. 2/10/05- seen by PA this am- pt's Case Manager contacted by this PA-brain CT and neuro consultation recommended by pt's Case Manager. Patient contacted by her Case Manager- denies any changes in above frequency of sxs- states left side head pain now spread to my right side- no change in pain intensity- pain not interfering with quality of life- no meds taken for her sxs- denies f/c, malaise, fatigue, upper respiratory sxs, n/v, tinnitus, photophobia, impaired vision, paresthesia, weakness, tremors, dizziness, lightheadedness or recent change in mood/mental clarity- no h/o ha, seizures or any other neuro problems/disorders- denies any recent h/o head trauma- denies any FH of autoimmune disorders/problems- states has had no problems with flu vaccines in the past. Feb 05 attempts made to contact pt. via phone for updates- no response. 2/22/05 received updated info from pt. via mail- states was treated with ZOVIRAX 5x/d for 10ds for BELL's palsy and states lyme disease titer was positive- states is currently being treated with Doxycycline BID x30ds. 3/22/05- medical records received. According to pt's medical records, this patient has successfully been treated for BELL's palsy which appeared five days after receiving her SPV and flu vaccine (2/3/05). Her last visit (3/18/05) to healthcare practitioner indicates that her facial numbness resolved after 2 wks (2/22/05), reports ha resolved, no vision change reported, denies any changes in CNS, no joint pain- repeat lyme titer ordered.									U	02/08/2005			Diagnostic Tests: Head CT (without contrast) = nl; Labs: 2/10/05, Lyme disease screen= 2/46 H (<1.0); Lyme disease interpret= positive; CBC with diff= nl; 3/14/05, HSV culture= positive; HSV type 1= positive	MIL	MIL	TYLENOL with Codeine #3 300 mg-30 mg		Herpes Simplex			1						1	Borrelia burgdorferi serology positive; Computerised tomogram normal; Differential white blood cell count normal; Facial palsy; Full blood count normal; Headache; Herpes simplex serology positive; Hypoaesthesia facial; Hypoaesthesia oral; Lip swelling; Local swelling; Pain in jaw	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|SMALL~UNKNOWN MANUFACTURER~~UNK~ID~UN~SMALLPOX (NO BRAND NAME)~1	USA		Influenza
0350225	06/17/2009		4.0			F	05/29/2009	Information has been received from a consumer concerning her daughter 4 years old who at 15 months old (2005) was vaccinated with a dose of MMR II (Lot not reported). On the same visit the patient received a dose of influenza virus vaccine (unspecified). The child is now 4 years old and had the speech abilities of a 2 year old. The child also developed a rough cold and was really sick after vaccination. At the time of reporting, 16-MAR-2009, the patient outcome was unknown. Additional information has been requested.									U				Unknown	OTH	OTH			Unknown		WAES0903USA02571	1						1	Malaise; Nasopharyngitis; Speech disorder	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0349494	06/18/2009	IN	41.0	41		F	06/18/2009	Fever 103, body aches, blotchy redness, and severe swelling to right upper arm especially near & surrounding PPSV injection site.  7/2/09 Hospital records received DOS 6/18/09 to 6/20/09. Assessment: Post-Operative Fever. Patient presented with fever nausea, vomiting, abdominal pain, passing gas. Right arm swelling at the site of vaccine injection.  ICD-9 Codes: 780.63, 789.07, V45.79					Y	2			Y	06/15/2009	06/17/2009	2	CT scan ruled out post op infection as source of fever.   7/2/09 Hospital records received DOS 6/18/09 to 6/20/09. LABS and DIAGNOSTICS: CBC - WBC 15.6 X10*3 (H) RDW 10.8% (L) Eosinophil 0.9% (L) Abs Neutrophil 11.9 X19*3 (H). CHEM - BUN 6 mg/dL (L) Sodium 134 mmo/L (L) AST 41 U/L (H) Lipase 56 U/L (L).	UNK	UNK	Propanolol, Alavert D, Darvocet, Xanax, Wellbutrin, Bayer vitamin	following laparoscopic cholecystectomy	Codeine, aspirin. 7/2/09 Hospital records received DOS 6/18/09 to 6/20/09. Recent laparoscopic cholecystectomy.	None~ ()~~0.00~Patient|None~ ()~~0.00~Sibling|None~ ()~~0.00~Sibling		1						1	Computerised tomogram normal; Injection site erythema; Injection site swelling; Pain; Pyrexia; Rash macular	FLU3~SANOFI PASTEUR~U2770A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~972210604654~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C3058AA~UNK~IM~LA~TDAP (ADACEL)~1	USA	Hospitalisation	Influenza
0349524	06/18/2009	PA	34.0	34		M	06/09/2009	Right deltoid where Tdap administered on 6/6/09 became indurated, erythematous, swollen, warm, painful. On Monday 6/8 patient seen in office and induration = 7 x 7 cm. On 6/9 induration was 18 x 11 cm and very painful. Induration site of Tdap. Pt received GSK flu vaccine lower on deltoid but rxn was at site of Tdap.									Y	06/06/2009	06/06/2009	0		PVT	PVT	None	Pure Hyperglyceridemia	None			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA192BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B039AA~UNK~IM~UN~TDAP (BOOSTRIX)~1	USA		Influenza
0349532	06/18/2009	VT	1.0	1	.0	F	06/18/2009	Pt father reported it looked like hives all over - Rash-1wk- after MMR II, VARIVAX, HAVRIX given. Red itchy papules 2mm-1cm varying site and location. Lasted 1mo. No resp sx. No intercurrent illness.				Y					Y	03/18/2009	03/28/2009	10	None	PVT	OTH	None	Conjunctivitis	None			1						1	Erythema; Rash generalised; Rash papular; Rash pruritic; Urticaria	FLU3~SANOFI PASTEUR~UT2792FA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB329CA~1~IM~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1506X~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1397X~1~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0349549	06/19/2009		96.0			F	06/18/2009	Information has been received from a Registered Pharmacist (R. Ph.) concerning a 96 year old female who was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck) on an unspecified date. Concomitant therapy included a dose of flu shot (manufacture unknown). Subsequently the patient developed GUILLAIN-BARRE syndrome and was hospitalized. At the time of reporting the patient was in the hospital for this AE. The patient sought unspecified medical attention. The outcome was unknown. Additional information has been requested.					Y	0			U				Unknown	OTH	OTH			Unknown		WAES0906USA01892	1						1	Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Hospitalisation	Influenza
0349584	06/19/2009	MI	1.17	1	.2	M	06/19/2009	LYMPHNODE ENLARGED ON L INGUNAL REGION ABOUT 1CM IN DIAMETER MMR GIVEN SQ IN L THIGH										06/02/2009	06/19/2009	17		PVT	PVT				1 CM INGUNAL REGION~Measles + Mumps + Rubella (MMR II)~0~1.40~In Patient		1						1	Lymphadenopathy	FLU3~SANOFI PASTEUR~UT2797FA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1605X~1~IM~RL~HEP A (VAQTA)~1|MMR~MERCK & CO. INC.~1505X~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0349585	06/19/2009	GA	64.0	64		M	06/19/2009	ON the site of the flu shot there is a 5cm areA of macular erythema with multiple  confluent vesicles . Across the mid chest large patches of macular erythem with  vesicle.									Y	12/09/2008	12/10/2008	1		PVT	UNK	WARFARIN, TRAZODONE, COMBIVENT, METOPROLOL, SIMVASTATIN, LASIX, GABAPENTIN, ALDACTONE, MOMETASONE ORAL MDI	NONE	DILTIAZEM - NAUSEA/VOMITING			1						1	Blister; Erythema; Injection site erythema; Injection site vesicles; Rash macular	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0349660	06/22/2009	WV	49.0			M	06/18/2009	This case was received from a health professional on 09 June 2009. A 49-year-old male patient, with a history of seasonal allergies, received an injection of FLUZONE SV '2005-'2006 USP (lot number U1753AA) on 27 October 2005. Two days post-vaccination, on 29 October 2005, he experienced malignant hypertension, tachycardia, hot and cold sensations, and ringing in the ears. He was treated with three courses of prednisone, and underwent a full cardiac work-up (results not provided). The hot and cold sensation and ringing in the ears remained ongoing. Of note, the patient had also received a flu vaccine (manufacturer and lot number not reported) in January 2005. In addition, this reporter noted that the patient's sister also experienced a similar event after receiving FLUZONE (lot number U1846AA) in 2005. That event is captured in case number 2009-02506.				Y					N	10/27/2005	10/29/2005	2		MIL	OTH			Medical history included multiple seasonal allergies.	Cardiac diso~Influenza (Seasonal) (Fluzone)~~0.00~Patient	200902505	1						1	Cardiac monitoring; Feeling of body temperature change; Malignant hypertension; Tachycardia; Tinnitus; Cardiac monitoring; Feeling of body temperature change; Malignant hypertension; Tachycardia; Tinnitus	FLU3~SANOFI PASTEUR~U1753A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U1753AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0349661	06/22/2009	WV				F	06/18/2009	This case was received from a health care professional on 09 June 2009. A female patient received an injection of FLUZONE SV '2005-'2006 USP (lot number U1846AA) on 17 October 2005. Within a few days of vaccination, she experienced cardiac like symptoms. No additional information was reported. The reporter in this case also reported that the patient's brother experienced similar symptoms after receiving FLUZONE in 2005 (lot number U1753AA). This information is captured in case number 2009-02505.				Y					U	10/17/2005				OTH	OTH				Cardiac diso~Influenza (Seasonal) (Fluzone)~~0.00~Patient	200902506	1						1	Cardiac disorder	FLU3~SANOFI PASTEUR~U1846A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0349723	06/22/2009		49.0	49		M	06/13/2009	Within 15-20 minutes of vaccines my throat was scratchy. This progressed to swelling & severe tenderness of lower, external neck X 1wk. Hard to swallow.									Y	10/21/2008	10/21/2008	0	None	MIL	MIL	Lisinopril 10 mg QD	None	Mild allergy to Indocin - slight rash	Seizure~Measles + Mumps + Rubella (no brand name)~1~1.30~Sibling		1						1	Dysphagia; Swelling; Tenderness; Throat irritation	FLU3~SANOFI PASTEUR~~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~~1~IM~RA~HEP A (HAVRIX)~1	USA		Influenza
0344399	06/23/2009		64.0			M	06/23/2009	This case was reported in a literature article and described the occurrence of hemorrhagic cerebral infarction in a 64-year-old male subject who was vaccinated with influenza virus vaccine (influenza vaccine, manufacturer unspecified). Concurrent medical conditions included atrial fibrillation, chronic obstructive pulmonary disease, depression, diabetes mellitus (type2), gastroesophageal reflux, hypercholesterolemia and hypertension. Concurrent medications included Warfarin 5 mg every other day alternating with 2,5 mg, Celecoxib 200 mg as needed for pain, ipratropium/albuterol inhaler 2 puffs twice daily, diltiazem 120 mg twice daily, metformin 500 mg twice daily, hydrochlorothiazide/losartan 25 mg/100 mg daily, escitalopram 20 mg daily, lansoprazole 30 mg daily, propranolol 40 mg twice daily, and ezetimibe/simvastatin 10 mg/40 mg daily. All medication regimens were unchanged for at least 6 months. None of his medications was altered. The patient had been seen in the clinic 5 weeks prior to presentation. At the time, his INR was 2,0 and he received unspecified dose of Influenza vaccine (unknown route, unknown injection site). Lot number was not available. 5 weeks after vaccination with Influenza vaccine, the subject was hospitalized after becoming unresponsive at home. At the admission, the patient had been unresponsive for approximately 1 hour. The patient was experiencing rectal bleeding for the previous 2 days. The initial international normalized ratio (INR) was greater than 15; INR values over the previous 6 months were relatively stable. Relevant test were performed and showed the following results: Hemoglobin: 8,3 g/dL (normal range 14-18); Hematocrit: 24% (normal range 42-52); Platelet count: 412 x 10^3 /uL (normal range 150-430); low serum albumin: 3,1 g/dL (normal range 3,5-5,0); total bilirubin: 0,8 mg/dL (normal range 0,2-1,0); aspartate aminotransferase: 16 IU/L (normal range 10-42); alanine aminotransferase:12 IU/L (normal range 10-40); blood pressure: 166/60 mm Hg, heart rate: 62 beats/min; respiration rate:16 breaths/min; temperature was not documented. A non-contrast computed tomography scan of the head revealed a large parenchymal hemorrhagic infarction involving the left temporal, parietal, and occipital lobes. The radiologist noted a significant mass effect including 12mm rightward midline shift and impending uncal herniation. The subject was treated in the emergency department with Nitroglycerin infusion to maintain systolic blood pressure in the range of 140-160 mm Hg as well as the infusion of 4 units of fresh frozen plasma and 10 mg of vitamin K. Following a neurosurgery evaluation, it was determined that nothing meaningful could be done to alter the patient's outcome positively. Comfort measures were implemented and the patient died approximately 17 hours after admission. The author considered the events were possibly related to the interaction between Warfarin and vaccination with Influenza vaccine.	Y			Y	Y				N				Alanine aminotransferase, 12UI/L; Aspartate aminotransferase, 16UI/L; Bilirubin total, 0.8 mg/dl; Blood pressure, 166/60mmHg; Computerized tomogram head, infarction, Heart rate, 62beats/min; Hematocrit, 24%; Hemoglobin, 8.3g/dl; International normalized ratio, more than 15; Platelet count, 412000/ul; Respiratory rate, 16breaths/min; Serum albumin decreased, 3.1g/dl	OTH	OTH	Celecoxib; Ipratrop.Br+salbutam.SO4 (Salbutamol sulphate - Ipratropium bromide); Diltiazem hydrochloride; Metformin hydrochloride, Hydrochlorothiaz.+lozartan; Citalopram; Lansoprazole; Non-GSK Propranolol hcl; Ezetimibe + Simvastin (Simvast	Atrial fibrillation; Chronic obstructive pulmonary disease; Depression; Diabetes Mellitus (Type2) Gastroesophageal Reflux; Hypercholesterolemia; Hypertension			B0579153A	1						3	Cerebral infarction; Computerised tomogram abnormal; Death; Haemorrhage intracranial; International normalised ratio fluctuation; Rectal haemorrhage; Unresponsive to stimuli; Alanine aminotransferase normal; Aspartate aminotransferase normal; Blood albumin decreased; Blood bilirubin normal; Blood product transfusion; Brain herniation; Brain mass; Computerised tomogram abnormal; Death; Haematocrit decreased; Haemoglobin decreased; Haemorrhagic infarction; International normalised ratio increased; Platelet count normal; Rectal haemorrhage; Unresponsive to stimuli; Alanine aminotransferase normal; Aspartate aminotransferase normal; Blood albumin decreased; Blood bilirubin normal; Blood product transfusion; Computerised tomogram abnormal; Computerised tomogram head; Death; Haematocrit decreased; Haemoglobin decreased; Haemorrhagic cerebral infarction; Heart rate normal; International normalised ratio increased; Platelet count normal; Rectal haemorrhage; Respiratory rate; Unresponsive to stimuli; Alanine aminotransferase normal; Aspartate aminotransferase normal; Blood albumin decreased; Blood bilirubin normal; Blood product transfusion; Cerebral infarction; Computerised tomogram abnormal; Death; Haematocrit decreased; Haemoglobin decreased; Haemorrhagic infarction; International normalised ratio increased; Platelet count normal; Rectal haemorrhage; Unresponsive to stimuli	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|FLU3~CSL LIMITED~~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~4	USA	Results in Death	Influenza
0349822	06/23/2009	AR	63.0	63		M	06/02/2009	112408 - Pt c/o pain in feet; 112508 pain cont, now can't pick up objects with hands; 112608 requires assist to walk into ER; 112708 is now bedbound. Test, plasmapheresis - anemia - RBC given - rehab  7/7/09 MR received for DOS 12/20/2008-01/08/2009 with D/C DX:  Guillain_Barre Syndrome, axonal type.  HTN.  DM.  Mild tachycardia.  Pt presented with progressive weakness in LEs, then hands. PE (+) for decreased strength and sensation. Absent reflexes. Pt c/o severe pain and muscle spasm of lower extremities, 1-2+ LE edema. DVTs noted in LEs tx with anticoagulants. Plasmapheresis with little improvement. One dose of IVIG with some improvement.  Transferred for rehab on 1/8/09.    ICD9:  V5783.  3570. 4019.  /				Y	Y	44		Y	Y	11/07/2008	11/24/2008	17	Dx: Guillain-Barre Synd; Electromyography; CXR, MRI Spine; Lumbar puncture Labs and diagnostics:  LP traumatic but WNL.  MRI sppine (+) for degenerative changes and stenosis. EMG/NCS abnormal.  BS 67-175.  PT 20.1-29.1. Venous dopplers (+) for popliteal vein thrombus.	PUB	PUB	None	None	NIDDM; HTN PMH:  HTN.  DM.  Tachycardia.Sinus surgery. appy.  Herniated disc w/ surgery. Nausea, diarrhea and vomiting 11/2008.			1						1	Anaemia; Bedridden; Chest X-ray; Gait disturbance; Grip strength decreased; Guillain-Barre syndrome; Lumbar puncture; Pain in extremity; Plasmapheresis; Transfusion	FLU3~SANOFI PASTEUR~2840AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0350025	06/24/2009	VI	1.2	1	.2	F	06/22/2009	Mother states bumpy rash to both arms & legs 1 day after vaccine. Followed up with pediatrician & dermatologist who Rx cream & rash subsided temporarily but came back after the cream & prednisone was complete. Now is seeing allergist who is running tests.				Y					N	05/13/2009	05/14/2009	1	information not provided to me	PUB	UNK		None	None			1						1	Rash	FLU3~SANOFI PASTEUR~U2941CA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB264CA~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1729X~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0187Y~1~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0350042	06/24/2009	NY	68.0	68		F	06/24/2009	Pt. with erythematous plaque to L deltoid posterior to injection site. No heat, no streaking, no tenderness, no s/s of infection. Pt denies pain, has FROM, only concerned regarding discoloration erythema started 1 wk after injection - likely injection is not the cause. Ice, Ibuprofen, RTC if pain or loss of ROM or increasing in size.										06/17/2009	06/23/2009	6	No prior H/o allergic reaction to Td.	PVT	OTH		Denies	Denies any medical problem. NKDA.			1						1	Erythema; Skin discolouration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~E81133P~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TD~SANOFI PASTEUR~U2332DA~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0328946	06/25/2009	OH	51.0	51		F	06/22/2009	Report received from a consumer on 11-Dec-2008. An adult female (date of birth: unknown) received a 'vaccine' for influenza immunization in Oct-2008. No details of medication history or concomitant medication was provided. The patient was not sure if she was vaccinated with AFLURIA, nor was she sure of the exact date of vaccination. The patient stated she was vaccinated with AFLURIA last year (2007), bud she did not experience any adverse events. On an unknown date, 24 hours after vaccination, the patient experienced facial swelling (whole face). Currently she states that her face looks sagging because of stretched skin from the swelling. At the time of reporting the patient had not recovered. Awaiting further information. Follow-up information received on 12-Dec-2008 from a registered pharmacist (RPh). The patient was a 51 year-old female. She received ALFURIA (CSL influenza vaccine) by IM injection (lot 02049111A) for influenza immunization 04-Oct-2008. The patient told the RPh that she had a swollen face on 04-Oct-2008. Event required emergency room/doctor visit. She was given 100ct box of BENADRYL and prescribed prednisone. The RPh does not know if patient recovered from this reaction. At the time of the vaccination the patient had no illness. The RPh did not know of any pre-existing allergies or medical conditions. In 2007, patient was administered FLUARIX, not AFLURIA as initially stated by patient. The company considered events as possibly related to the administration of AFLURIA. Follow-up information received on 18-Dec-2008 from a Claims Management Service. Patient received a flu shot and stated her face had swollen. The patient was instructed by her physician to take BENADRYL. It is unknown if patient has allergies. Information derived from this report does not change the current safety profile of AFLURIA.				Y					U	10/04/2008	10/04/2008	0		OTH	PVT		None	None		200814450	1						2	Facial palsy; No reaction on previous exposure to drug; Swelling face	FLU3~CSL LIMITED~02049111A~UNK~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~2	USA	Emergency room visit	Influenza
0334067	06/25/2009	MD				M	06/22/2009	Report was received from a physician assistant on 17-Dec-2008. A male patient (age unknown) received a dose of AFLURIA on 23-Oct-2008. During the first week of Nov-2008, the patient experienced possible Guillain Barre Syndrome (progressive upper and lower extremity weakness, numbness and tingling, and radiating neck pain). The patient was admitted to a hospital on 06-Nov-2008 and stayed about 1 month. Further information has been requested. The company considered the events conditional/unclassified in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product.					Y	30			U	10/23/2008	11/01/2008	9		OTH	OTH					200814469	1						2	Hypoaesthesia; Muscular weakness; Neck pain; Paraesthesia	FLU3~CSL LIMITED~~UNK~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~2	USA	Hospitalisation	Influenza
0350106	06/25/2009	PA	26.0	26		M	06/20/2009	Pt was given a flu shot on Monday. On Thursday, pt experienced muscle weakness on one side, slurred speech, confusion, trouble swallowing. He was sent to Emergency Room. Brain scan revealed it was not a stroke. MRI - possible ADEM Brain demyelination. Given IV treatments/saline solution.  6/26/09 Hospital records and DC summary received DOS 11/07/08 to 11/10/08. Assessment: Left hemiparesis, schizophrenia, dyslipidemia, Charcot-Marie-Tooth. Presented with acute onset left hemiparesis. Paresthesias left hand. Speech dysarthric.   9/23/09 Medical records received: ICD9 codes: 272.4, 356.1, 785.0, 295.9, 342.9, 323.9, v158.1, E939.3			Y	Y	Y	4		Y	N	11/03/2008	11/06/2008	3	6/26/09 Hospital records and DC summary received DOS 11/07/08 to 11/10/08.  LABS and DIAGNOSTICS: MRI Brain - abnormal. MRI Spine - abnormal. CT Angiogram - WNL. Echocardiogram - WNL.  Venous Doppler - WNL. LP - elevated protein. Demyelinating profile - Serum IgG 728 MG/DL (L) Serum Albumin 2990 MG/DL (L). Lyme (-). CBC - WNL. ALT 84 U/L - elevated. Leukemia Panel - Carnitine Esters 1.0 umol/L (L). MRSA Culture (-).	PUB	OTH	MAALOX, ATIVAN, LOXITANE, ZYPNEXA, COGENTIN		CMT; Allergies to milk and penicillin; Schizophrenia. PMH: Prior episodes of left hemiparesis, right hemiparesis, acute disseminated encephalomyelitis. Charcot-Marie-Tooth, dyslipidemia, schizophrenia, auditory and visual hallucinations.	same as above~Hep B (no brand name)~3~19.00~Patient		1						1	Brain scan normal; Confusional state; Dysarthria; Dysphagia; Hemiparesis; Muscular weakness; Nuclear magnetic resonance imaging brain abnormal	FLU3~SANOFI PASTEUR~U2768AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0350162	06/25/2009	IA	0.6	0	.6	M	06/18/2009	progressive decreased motor skills LE >> VE Dxd -  transverse myelitis.  7/2/09 Hospital records received DOS 5/29/09 to 6/2/09. Assessment: Transverse myelitis, constipation, mild anemia, left empty scrotum or cryptorchism. Patient presented with bilateral lower extremity weakness. More fussy than usual, waking up during the night, not rolling over, fell over from sitting position, will not bear weight and 'crumble' to the ground. No movement lower extremities. PO intake decreased. 4-5 wet diapers. 1 small hard bowel movement last 24 hours. Patellar and Achilles reflexes 3+/5 bilaterally. Ankle clonus. Limited hand extension and weaker pincer on right. Truncal weakness. 7/22/09-ICD-9 code 341.20					Y	5			U	05/04/2009	05/28/2009	24	5/29 MRI head & spine. LABS and DIAGNOSTICS: 7/2/09 Hospital records received DOS 5/29/09 to 6/2/09. MRI Spine - abnormal intrinsic cord signal. MRI Brain - WNL. CHEM - AST 47 U/L (H) Glucose 117 mg/dL (H). CK 220 U/L (H). CBC - RBC 3.85 million (L) HGB 10.1 g/dL (L) HCT 29.3% (L). CSF - WBC 11 cmm (H). Numerous immunological and micrological studies WNL.	PVT	PVT		Mild URI 1-2 week prior illness	Unilateral Cryptorchidism - CF carrier.			1						1	Hypokinesia; Myelitis transverse; Nuclear magnetic resonance imaging; Nuclear magnetic resonance imaging abnormal	DTAPIPVHIB~SANOFI PASTEUR~C3290AA~3~UN~LL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~UT2782AA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~D34347~3~UN~RL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0350841	06/25/2009	IL	59.0	59		F	06/22/2009	Migraine. Migraine with loss of central vision. Felt sickly. Diarrhea. Slight headache. Fatigue. Chills. Aches. Report received from a consumer on 05-Nov-2008. An adult female patient (initials: SW; DOB: unknown) received FLURIA (CSL influenza vaccine) on 29-Oct-2008 at 8:00 am. At 4:00 pm on 29 Oct-2008, the patient had a migraine with loss of vision (patient could not see clearly out of both eyes). For the next day and a half, she felt sickly and had diarrhea. She saw her family physician on 29-Oct-2008 and her blood pressure was fine and had no droopy eye. No treatment was given but physician may prescribe IMITREX. On 03-Nov-2008, the patient saw an eye specialist and everything was fine; no detached retinal. Patient complained of a slight headache on 05-Nov-2008, but feels much better. A brain MRI is scheduled for 06-Nov-2008. Patient has had 1/2 dozen migraines in her life. She has received flu shots in the past with no problems. ASSESSMENT: No serious criteria mentioned. The company considered events as possibly related to the suspect drug. Follow-up information received on 11-Nov-2008 from the consumer. A 59 year old non-pregnant female received AFLURIA, lot 02549111A, IM arm on 29-Oct-2008 at 8:00 am. At the time of vaccination, she had no illness. Patient does have a history of hypothyroidism and osteoarthritis. Concomitant medications include SYNTHROID, MOBIC, PREMPRO, doses unspecified. On 29-Oct-2008 at 4:00 pm, patient reported that she had a migraine headache, loss of central vision, fatigue, aches, and chills. Patient had an MRI of brain and orbital sockets, and a complete blood count (CBC) and ferritin level was obtained. Blood work was done on 10-Nov-2008; results not yet received. She is being tested for anemia. If anything is not right with her blood work, she will report back to us. Patient stated that she recovered by 04-Nov-2008 from all reactions. No further information is expected. No change in assessment. Information derived from this AE report does not change the current safety profile of AFLURIA (CSL influenza vaccine).				Y					Y	10/29/2008	10/29/2008	0	MRI of Brain and orbital Sockets; CBC; Ferritin level	OTH	OTH	SYNTHROID; MOBIC; PREMPRO	None	History of migraines; Hypothyroid; Arthritis-osteo		200814279	1						1	Blindness; Chills; Condition aggravated; Diarrhoea; Fatigue; Full blood count; Headache; Malaise; Migraine; Nuclear magnetic resonance imaging brain; Pain	FLU3~CSL LIMITED~02549111A~1~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0350842	06/25/2009	MT	80.0			M	06/22/2009	Report received from a nurse on 03-11-2008.  An 80 year-old male patient received AFLURIA 0.5 ml pre-filled syringe on 14-Oct-2008.  Concomitant medications include Prilosec (omeprazole), which the patient has been taking for many years.  The patient has no known allergies;  no allergies to eggs.  He has had a flu shot every year for the last 15 years with no reactions.  On 21-Oct-2008, seven days after vaccination, the patient experienced hives which were itchy all over his body.  The patient went to the clinic on 23-Oct-2008 and was given a Decadron (dexamethasone) shot.  This helped but the patient reports 30% of the hives remained a few days after the Decadron shot.  The nurse states that 10 days later (31-Oct-2008), the patient still had some hives.  At the time of reporting (03-Nov-2008), the nurse was not sure how the patient was doing.  Awaiting further information.									U	10/14/2008	10/21/2008	7		OTH	OTH	PRILOSEC				200814291	1						1	No reaction on previous exposure to drug; Pruritus generalised; Urticaria	FLU3~CSL LIMITED~~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0350843	06/25/2009	WA				U	06/22/2009	Report received from a paramedic/fire fighter on 05-Nov-2008. Reporter stated that four (4) patients experienced flu-like symptoms (nasal congestion, chest tightness, general muscle aches, and malaise). One (1) out of the four (4) experienced chest congestion (see case 200914610). All four (4) patients received the AFLURIA dose on approximately 29-Oct-2008 and experienced the adverse effects three (3) days later (01-Nov-2008). As of 05-Nov-2008, all symptoms are milder for all patients. No patient went to the emergency room. (See cases 200914608, 200914609, and 200914610). Several attempts have been made to the reporter to confirm and verify the number of patients involved. To date, reporter has not provided a response. Patient outcome is unknown. No further information is expected. The manufacturer considered causality possible in relation to the administration of AFLURIA. Information derived from this ADR report does not change the current safety profile of the product.									U	10/29/2008	11/01/2008	3		OTH	OTH					200914591	1						1	Chest discomfort; Influenza like illness; Malaise; Myalgia; Nasal congestion	FLU3~CSL LIMITED~~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0350844	06/25/2009	WA				U	06/22/2009	Report received from a paramedic/fire fighter on 05-Nov-2008. Reporter stated that four patients experienced flu-like symptoms (nasal congestion, chest tightness, general muscle aches, and malaise). One out of the four experienced chest congestion (see case 200914610). All four patients received the AFLURIA dose on approximately 29-Oct-2008 and experienced the adverse effects three days later (01-Nov-2008). As of 05-Nov-2008, all symptoms are milder for all patients. No patients went to the emergency room. (See cases 200914591, 200914609, and 200914610). Several attempts have been made to the reporter to confirm and verify the number of patients involved. To date, reporter has not provided a response. Patient outcome is unknown. No further information is expected. The manufacturer considered causality as possible in relation to the administration of AFLURIA. Information derived from this ADR report does not change the current safety profile of the product.									U	10/29/2008	11/01/2008	3		OTH	OTH					200914608	1						1	Chest discomfort; Influenza like illness; Malaise; Myalgia; Nasal congestion	FLU3~CSL LIMITED~~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0350845	06/25/2009	WA				U	06/22/2009	Report received from a paramedic/fire fighter on 05-Nov-2008.  Reporter stated that four (4) patients experienced flu-like symptoms (nasal congestion, chest tightness, general muscle aches, and malaise).  One (1) out of the four (4) experienced chest congestion (200914610).  All four (4) patients received the AFLURIA dose on approximately 29-Oct-2008 and experienced the adverse effects three (3) days later (01-Nov-2008).  As of 05-Nov-2008, all symptoms are milder for all patients.  No patients went to the emergency room.  (See cases 200914591, 200914608, and 200914610).  Several attempts have been made to the reporter to confirm and verify the number of patients involved.  To date, reporter has not provided a response.  Patient outcome is unknown.  No further information is expected.  The manufacturer considered causality possible in relation to the administration of AFLURIA.  Information derived from this ADR report does not change the current safety profile of the product.									U	10/29/2008	11/01/2008	3		OTH	OTH					200914609	1						1	Chest discomfort; Influenza like illness; Malaise; Myalgia; Nasal congestion; Respiratory tract congestion	FLU3~CSL LIMITED~~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0350846	06/25/2009	WA				U	06/22/2009	Report received from a paramedic/fire fighter on 05-Nov-2008. Reporter stated that four (4) patients experienced flu-like symptoms (nasal congestion, chest tightness, general muscle aches, and malaise) One (1) out of four (4) experienced chest congestion. All four (4) patients received the AFLURIA dose on approximately 29-Oct-2008 and experienced the adverse effects three (3) days later (01-Nov-2008). As of 05-Nov-2008, all symptoms are milder for all patients. No patients went to the emergency room. (See cases 200914591, 200914608, and 200914609). Patient outcome is unknown. Several attempts have been made to the reporter to confirm and verify the number of patients involved. To date, reporter has not provided a response. No further information is expected. Manufacturer considered causality possible in relation to the administration of AFLURIA. Information derived from this ADR report does not change the current safety profile of the product									U	10/29/2008	11/01/2008	3		OTH	OTH	None	None	None		200914610	1						1	Chest discomfort; Influenza like illness; Malaise; Myalgia; Nasal congestion	FLU3~CSL LIMITED~~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0350847	06/25/2009	NY	79.0	79		F	06/22/2009	Injection site pain lasting 3 months									U	12/23/2008	12/23/2008	0		OTH	OTH	COUMADIN	Stroke in Dec 2008	Minor back surgery in Nov 2008; Fractured pelvis in Nov 2008		200914789	1						1	Injection site pain	FLU3~CSL LIMITED~04549111A~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0350255	06/26/2009	RI	49.0	49		F	06/22/2009	Persistent pain in left arm after receiving flu shot.									U	10/09/2008	10/10/2008	1		PUB	PUB	CADUET and ZANTAC	None	Hypertension			1						1	Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA364AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0350388	06/29/2009					U	06/30/2009	We received the following literature report on 15 JUN 2009:  15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007.  The children received a total of two doses (fully vaccinated).  Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness.  Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group.  This case refers to one child (for other children, please refer to reference cases MA2009-1708 to MA2009-1710 and MA2009-1712 to MA2009-1722).  Laboratory-confirmed influenza illness was reported (date?). Request was sent on 22 JUN 2009, no follow-up information received.									U					OTH	OTH	No other medications	Unknown			MA20091692	1						1	Influenza; Influenza serology positive	FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0350392	06/29/2009					U	06/30/2009	We received the following literature report on 15 JUN 2009: 15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007. The children received a total of two doses (fully vaccinated). Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness. Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group. This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1709 to MA2009-1710 and MA2009-1712 to MA2009-1722). Laboratory-confirmed influenza illness was reported (date?). Request was sent on 22 JUN 2009, no follow-up information received.									U					OTH	OTH	No other medications	Unknown			MA20091708	1						1	Influenza; Influenza serology positive	FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0350393	06/29/2009					U	06/30/2009	We received the following literature report on 15 JUN 2009:  15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007.  The children received a total of two doses (fully vaccinated).  Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness.  Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group.  This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1708, MA2009-1710 and MA2009-1712 to MA2009-1722).  Laboratory-confirmed influenza illness was reported (date?). Request was sent on 22 JUN 2009, no follow-up information received.									U					OTH	OTH	No other medications	Unknown			MA20091709	1						1	Influenza; Influenza serology positive	FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0350394	06/29/2009					U	06/30/2009	We received the following literature report on 15 JUN 2009. 15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007. The children received a total of two doses (fully vaccinated). Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness. Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group. This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1708 to MA2009-1709 and MA2009-1712 to MA2009-1722). Laboratory-confirmed influenza illness was reported (date?).  Request was sent on 22 JUN 2009, no follow-up information received.									U					OTH	OTH	No other medications	Unknown			MA20091710	1						1	Influenza; Influenza serology positive	FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0350396	06/29/2009					U	06/30/2009	We received the following literature report on 15 JUN 2009: 15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007. The children received a total of two doses (fully vaccinated). Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness. Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group. This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1708 to MA2009-1710 and MA2009-1713 to MA2009-1722). Laboratory-confirmed influenza illness was reported (date?). Request was sent on 22 JUN 2009, no follow-up information received.									U					OTH	OTH	No other medications	Unknown			MA20091712	1						1	Influenza; Influenza serology positive	FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0350397	06/29/2009					U	06/30/2009	We received the following literature report on 15 JUN 2009:  15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007.  The children received a total of two doses (fully vaccinated).  Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness.  Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group.  This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1708 to MA2009-1710, MA2009-1712 and MA2009-1714 to MA2009-1722).  Laboratory-confirmed influenza illness was reported (date?). Request was sent on 22 JUN 2009, no follow-up information received.									U					OTH	OTH	No other medications	Unknown			MA20091713	1						1	Influenza; Influenza serology positive	FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0350398	06/29/2009					U	06/30/2009	We received the following literature report on 15 JUN 2009: 15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007. The children received a total of two doses (fully vaccinated). Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness. Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group. This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1708 to MA2009-1710, MA2009-1712 to MA2009-1713 and MA2009-1715 to MA2009-1722). Laboratory-confirmed influenza illness was reported (date?). Request was sent on 22 JUN 2009, no follow-up information received.									U					OTH	OTH	No other medications	Unknown			MA20091714	1						1	Influenza; Influenza serology positive	FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0350399	06/29/2009					U	06/30/2009	We received the following literature report on 15 JUN 2009: 15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007. The children received a total of two doses (fully vaccinated). Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness. Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group. This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1708 to MA2009-1710, MA2009-1712 to MA2009-1714 and MA2009-1716 to MA2009-1722). Laboratory-confirmed influenza illness was reported (date?). Request was sent on 22 JUN 2009, no follow-up information received.									U					OTH	OTH	No other medications	Unknown			MA20091715	1						1	Influenza; Influenza serology positive	FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0350401	06/29/2009					U	06/30/2009	We received the following literature report on 15 JUN 2009. 15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007. The children received a total of two doses (fully vaccinated). Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory confirmed influenza illness. Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group. This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1708 to MA2009-1710, MA2009-1712 to MA2009-1715 and MA2009-1717 to MA2009-1722). Request was sent on 22 JUN 2009, no follow-up information received.									U					OTH	OTH	No other medications	Unknown			MA20091716	1						1	Influenza; Influenza serology positive	FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0350403	06/29/2009					U	06/30/2009	We received the following literature report on 15 JUN 2009: 15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007. The children received a total of two doses (fully vaccinated). Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness. Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group. This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1708 to MA2009-1710, MA2009-1712 to MA2009-1716 and MA2009-1718 to MA2009-1722). Laboratory-confirmed influenza illness was reported (date?). Request was sent on 22 JUN 2009, no follow-up information received.									U					OTH	OTH	No other medications	Unknown			MA20091717	1						1	Influenza; Influenza serology positive	FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0350404	06/29/2009					U	06/30/2009	We received the following literature report on 15 JUN 2009.  15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007.  The children received a total of two doses (fully vaccinated).  Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness.  Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group.  This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1708 to MA2009-1710, MA2009-1712 to MA20091717 and MA2009-1719 to MA2009-1722).  Laboratory-confirmed influenza was reported (date?). Request was sent on 22 JUN 2009, no follow-up information received.									U					OTH	OTH	No other medications	Unknown			MA20091718	1						1	Influenza; Influenza serology positive	FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0350406	06/29/2009					U	06/30/2009	We received the following literature report on 15 JUN 2009:  15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007.  The children received a total of two doses (fully vaccinated).  Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness.  Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group.  This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1708 to MA2009-1710, MA2009-1712 to MA2009-1718 and MA2009-1720 to MA2009-1722).  Laboratory-confirmed influenza illness was reported (date?). Request was sent on 22 JUN 2009, no follow-up information received.									U					OTH	OTH	No other medications	Unknown			MA20091719	1						1	Influenza; Influenza serology positive	FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0350407	06/29/2009					U	06/30/2009	We received the following literature report on 15 JUN 2009: 15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007. The children received a total of two doses (fully vaccinated). Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness. Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group. This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1708 to MA2009-1710, MA2009-1712 to MA2009-1719 and MA2009-1721 to MA2009-1722). Laboratory-confirmed influenza illness was reported (date?). Request was sent on 22 JUN 2009, no follow-up information received.									U					OTH	OTH	No other medications	Unknown			MA20091720	1						1	Influenza; Influenza serology positive	FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0350408	06/29/2009					U	06/30/2009	We received the following literature report on 15 JUN 2009. 15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007. The children received a total of two doses (fully vaccinated). Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness. Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with unvaccinated group. This case refers to one child (for other children please refer to reference cases MA2009-1692, MA2009-1708 to MA2009-1710, MA2009-1712 to MA2009-1720 and MA2009-1722). Laboratory-confirmed influenza illness was reported (date?). Request was sent on 22 JUN 2009, no follow-up information received.									U					OTH	OTH	No other medications	Unknown			MA20091721	1						1	Influenza; Influenza serology positive	FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0350410	06/29/2009					U	06/30/2009	We received the following literature report on 15 JUN 2009. 15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007. The children received a total of two doses (fully vaccinated). Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness. Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group. This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1708 to MA2009-1710 and MA2009-1712 to MA2009-1721. Laboratory-confirmed influenza illness was reported (date?).  Request was sent on 22 JUN 2009, no follow-up information received.									U					OTH	OTH	No other medications	Unknown			MA20091722	1						1	Influenza; Influenza serology positive	FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0331080	06/30/2009	TX	50.0			U		Arms, back, stomach broke out with blotches when to two doctors- antibiotic given 1st Family Doctor gave shot to clear up reaction				Y					Y				Allergic reaction	PUB	UNK		None	Allergy to aspirin			1						2	Hypersensitivity; Rash macular	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Emergency room visit	Influenza
0350464	06/30/2009	PA	33.0	33		M	06/24/2009	Pt. developed onset of paresthesias (tingling) in B/L hands, neck stiffness, occas. hand numbness, hip pain, & feeling flushed on eve of 11/17/08. Flu shot given 11/4/08. NV on 11/18/08 -> referred to PCP. Eval. at ER 11/28/08 -> D/C with script for anxiolytic. Increasing ext pain -> ER 11/29/08 -> inpt. x8 days for daily plasmaphoresis.  7/1/09 Hospital records received DOS 11/30/09 to 12/07/08. Assessment: Guillain-Barre syndrome. Patient presented with tingling of hands and fingers, followed by flu-like symptoms with myalgias and arthralgias in several muscles and joints. Could barely ambulate and unable to work. Decreased muscle strength upper and lower extremities. Gait is wide-based, slow, and unsteady. Daily plasmaphoresis.				Y	Y	8			Y	11/04/2008	11/17/2008	13	LABS and DIAGNOSTICS: NCS - abnormal. Total CPK is 91. Alkaline Phosphatase is 97, SGOT 128, SGPT 301, Total Bilirubin is 0.4, albumin 4, globulin 3.8, BUN 16, creatinine 0.8. Hematocrit is 45, WBC 10400, platelet count 316000. CSF glucose was 69, CSF protein 208. CSF shows 3 WBCs and 0 RBCs. Sed rate is 7. CT and MRI are unremarkable.	OTH	PVT	None at time of vaccination -> currently on METOPROLOL.	None known	None known or specified . PMH: back pain, right tibia / fibula fracture requiring ORIF.			1						1	Arthralgia; Flushing; Hypoaesthesia; Musculoskeletal stiffness; Nausea; Pain in extremity; Paraesthesia; Plasmapheresis; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89745~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0350543	06/30/2009	CA	14.0	14		F	06/28/2009	Faints - blacks out - low blood pressure. Extreme pain in legs and body. Body jerks no concentration brain fog. Rashes, joint pain Fatigue, constipation weight loss - nausea. Headaches bedridden long periods.  7/20/09 Hospital records received DOS 7/18/08 to 7/13/09. Assessment: Orthostatic hypotension and Fibromyalgia. Syncope and Collapse. Migraine. Aversion to eating. Chronic pain syndrome. Multiple ER visits and hospitalizations. Chronic diarrhea and dizzy spells. Decreased PO intake. Weight loss. Headache, blurry vision. Mental status change. Confusion, inability to eat. Uncontrolled pain. Loss of consciousness. On birth control pills. Constipation. 9/4/09 Received ICD9 codes: 4516; 43239; 4580; 7291; 27651; 78701; 78321; 78052; 3384; 56400; 2871.  7/1/09 Medical records received DOS 6/20/07 to 12/24/07 Assessment: Fatigue, arthralgia, myalgia, easy bruising, lack of concentration. Patient presnts with lower leg pain, aching, sore arms, ankle bruising. Heavy menstrual period. Lack of concentration. Allergies. Painful skin with light touch. Constipation, SOB with excercise. Illness at time of immunization: Tired, not sleeping well. Body aches. Stress at school. Sore throat, Amox.				Y	Y	7	Y	Y	N	10/22/2007	11/01/2007	10	7/20/09 Hospital records received DOS 7/18/08 to 7/13/09. LABS and DIAGNOSTICS. Upper GI Series Normal. Abdominal Ultrasound Normal. CBC Normal. Metabolic Panel Normal. MRI/MRA Normal. Cortisol Stimulation Test WNL. Lyme titer - Borderline positive. Additional multiple labs and imaging studies WNL - refer to patient records.  7/1/09 Received medical records w/LABS and DIAGNOSTICS: T-4 0.8 ng/dL (L). Numerous immunological tests unremarkable.	PVT	UNK	None. Birth control pills.	None	None. 7/20/09 Hospital records received DOS 7/18/08 to 7/13/09. Fibromyalgia/chronic pain, platelet dysfunction, Lyme disease, orthostatic hypotension. Allergy to Stimate. Head trauma. Leg injury. Irregular menses. 7/1/09 Received medical records w/PMH: Excercise-induced asthma.			1						1	Arthralgia; Bedridden; Constipation; Disturbance in attention; Dyskinesia; Fatigue; Feeling abnormal; Headache; Hypotension; Loss of consciousness; Nausea; Pain in extremity; Rash; Syncope; Weight decreased; Abdominal pain; Activities of daily living impaired; Amnesia; Arthralgia; Asthenia; Asthenopia; Bone pain; Brain scan normal; Burning sensation; Chest pain; Computerised tomogram normal; Constipation; Contusion; Convulsion; Crying; Disturbance in attention; Disturbance in attention; Dizziness; Dyspepsia; Dysuria; Epstein-Barr virus infection; Fatigue; Feeling cold; Fibromyalgia; Gastrointestinal disorder; Hyperaesthesia; Hypotension; Insomnia; Laboratory test normal; Loss of consciousness; Lyme disease; Migraine; Muscle spasms; Muscle spasms; Nausea; Pain in extremity; Pruritus; Rash; Rash generalised; Scan brain; Scan brain; Sleep disorder; Somnolence; Speech disorder; Tinnitus; Visual impairment; Weight decreased; Weight decreased	FLU3~SANOFI PASTEUR~U2486AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1063U~1~UN~UN~HPV (GARDASIL)~1|FLU3~SANOFI PASTEUR~U2486AA~UNK~IJ~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|HPV4~MERCK & CO. INC.~1063U~UNK~IM~UN~HPV (GARDASIL)~2	USA	Hospitalisation,Disabling	Influenza
0350570	06/30/2009	NV	4.0	4		M	06/30/2009	Child was evaluated on 6/30/09 and noted to have confirmed case of diffuse varicella. Child's rash involved dozens of varicella lesions on trunk, back, abdomen, arms and legs, only a few on face. He appeared otherwise well without fever or other symptoms. Mild case.									U	11/21/2008	06/27/2009	218		PUB	PUB						1						1	Rash; Varicella post vaccine	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B064AA~3~IM~LL~DTAP (INFANRIX)~1|FLUX~SANOFI PASTEUR~U2808AA~1~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB243AA~2~IM~RL~HEP A (HAVRIX)~1|IPV~SANOFI PASTEUR~A09962~3~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0667X~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1006X~2~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0350576	06/30/2009	CA	20.0	20		M	06/30/2009	Pt was in excellent health prior to service entry in May 2009. 13 May 2009 - Pt received multiple vaccines - See Vaccine History. The total number of 5 vaccines administered was divided between injections in both of his arms (2 and 3). He does not recall any significant local reactions at his vaccination sites. 28 May 2009 - Pt reported to Sick call for evaluation of URI symptoms. He was treated with MUCINEX, TYLENOL and SUDAFED. He reports multiple sick contacts with similar URI symptoms. 1 June 2009 - Seen on Sick Call. Diagnosed with Bronchitis and prescribed ZITHROMAX. 2 June 2009 - Pt awoke with tingling, numbness and weakness of his entire body, except for his head and neck. He was seen on sick call for follow up of bronchitis and he was placed on 72 hour quarters. (There was no mention of the numbness or weakness in the clinic note.) 5June 2009 - Pt returned to Sick Call with c/o falling to his knees...can't feel legs, feet, shins, hands and fingers. (URI symptoms noted to have significantly improved.) No bowel or bladder symptoms or visual changes. Pt was released to duty. 8 June 2009 - Pt seen in the clinic for body numbness. The following were noted: - Gait off balance, ataxia, difficulty with balance - Increased concentration required to get dressed as buttons and laces hard to manipulate - Unable to feel when he plants his feet down - Difficulty writing and with fine manipulative tasks - Placed on 48 hour quarters. 10 June 2009 - Pt returned to sick call with c/o body numbness x 10 days and was referred to the ER after PCM consulted with Neurology. 11 June 2009 - Neurologist evaluated patient. HPI noted 10 day hx of numbness of all extremities and entire body, with subsequent generalized weakness, gait difficulty, soreness of calves and thighs. Exam revealed slightly diminished strength of UE and LE (4/5), with 3+/5 strength of distal muscle groups. Also on exam, pt was unable to walk a straight line, with abnormal heel walking and diminished DTRs in UEs and absent DTRs in LEs. Diagnosed with GBS. Treated with IVIGx5 days. Transferred to inpatient rehabilitation facility.  7/27/09 Hospital records received DOS 6/11/09 to 6/16/09. Discharge Diagnosis: Guillaine Barre Syndrome Patient c/o significant numbness in fingers and toes with generalized numbness of body below the neck.  Stumbles when he walks. Arthragias of knees, myalgias in thighs and calves. Easily fatigued, anorexia. URI symptoms such as cough and sore throat, bilateral upper extremity and lower extremity paresthesias, absent DTRs in bilateral lower extremities, decreased DTRs in bilateral upper extremities, weakness of the bilateral upper and lower extremities. Presence of CSF albuminocytologic dissociation (slightly elevated CSF protein with absent pleocytosis).					Y	7			N	05/13/2009	06/02/2009	20	6/1/09, CXR, WNL; 6/11/09, EMG/NCD - Summary interpretation: 1. The right median, ulnar, radial, sural and superficial peroneal sensory response were normal; 2. The right median-APB motor response was normal including F-waves and conduction velocity; 3. The right ulnar-ADM motor response has normal distal latency and amplitude. Proximal stimulation above the right elbow showed greater than 50% amplitude decrement as well as slowing of conduction velocity across the elbow. The F-wave latencies were prolonged; 4. The right peroneal-EDB and tibial-AH motor responses were normal including conduction velocities. The right peroneal-ADB F-waves were absent. The right tibial-AH F-waves were normal. 5. Verbal informed consent obtained. Concentric needle EMG of R[[name]] was normal; Conclusion: This is an abnormal study. There is electrophysiologic evidence of acquired demyelinating neuropathy in the upper and lower limbs consistent with AIDP (acute demyelinating polyradiculoneuropathy). This abnormal finding is compatible with the patient's clinical history of recent vaccination and URI symptoms, bil UE and [[name]] paresthesias, absent DTRS in the bil [[name]]/decreased DTRs in the bilateral UE, weakness of the bilateral UE/[[name]] and presence of CSF albuminocytologic dissociation (slightly elevated CSF protein [[address]]Head wo/contrast, impression: Normal contrast head CT apart from mild sphenoid sinus disease; 11 Jun 2009, CSF, Cell Count W/Diff, Color Colorless, appearance Clear; WBC, 3/mcL; RBC, 1 (H)/mcL; Lymphocytes, 72 %; Monocytes, 28 %; Protein, 68 (H) mg/dL; Glucose, 67 mg/dL; 11 Jun 2009, CSF, Cultures - Bacteriology Results: No growth in 3 days 06/14/09; Gram Stain: No cells or organisms seen; Gram Stain: AF 10Jun09; 11 Jun 2009, Serum, Reagin AB Non-reactive; Rheumatoid Factor less than 10 IU/mL; C-Reactive Protein High Sensitivity, 2.74 mg/dL; Nuclear Ab Negative; DNA Double Strand Ab Negative,  At less than 1:10; 11 Jun 2009 Blood, ESR 27;  11 Jun 2009, Serum, IqA 563 (H) mg/dL; Epstein-Barr Virus Capsid Ab IqG 3.76 (H); Epstein-Barr Virus Nuclear Ab more than 5.00 (H); Epstein-Barr Virus Capsid Ab IgM less OR = 0.90; 11 Jun 2009, Serum, Influenza Ab Profile, Influenza Virus B IgG Serum, 1.38; Influenza Virus A IgG Serum, 2.25; Influenza Virus A IgM Serum, 1.62; 13 Jun 2009, Blood Cultures- Status: Final - Bacteriology Result: No growth after 5 days; 13 Jun 2009, UA - Specific Gravity, 1.015; Protein Trace mg/dL, Negative; Glucose, Negative mg/dL; Ketones Trace (H) mg/dL, Negative; Bilirubin Negative mg/dL; Blood, Negative; Nitrite, Negative; Leukocyte Esterase, Negative; Appearance, Clear; pH, 5.5; Color, Yellow; Urobilinogen, less than 2.0 mg/dL; 14 Jun 2009, Stool - Date Resulted: 17 Jun 2009 1208, Bacteriology Result: Final Report, 06/17/09...PAD; Bacteriology Result: Decreased Coliforms noted; Bacteriology Result, No Salmonella, Shigella, or Campylobacter isolated. 7/27/09 Hospital records received DOS 6/11/09 to 6/16/09. LABS and DIAGNOSTICS: CXR - WNL. CT Head - Mild Sphenoid Sinus Disease, otherwise WNL. EMG/NCS - acquired demyelinating neuropathy in upper and lower limbs consistent with acute demyelinating polyradiculopathy. CHEM - Sodium 132 mmol/L (L) Potassium 5.3 mmol/L (L) Chloride 95 mmol/L (L) Protein 9.4 g/dL (H), Albumin 3.2 g/dL (L) Lactate Dehydrogenase 256 U/L (H). CSF - RBC 1 (H) Protein 68 mg/dL (H). ESR 27 (H). Serum IgA 563 mg/dL (H). Epstein-Barr Virus Capsid Ab IgG 3.76 (H). Epstein-Barr Virus Nuclear Ab >5.00 (H). Influenza Ab Profile - Influenza Virus B IgG serum 1.38 (+) Influenza Virus B IgM serum 1.96 (+) Influenza Virus A IgG serum 2.25 (+) Influenza Virus A IgM Serum 1.62 (+). Urinalysis - protein trace, ketones trace. CBC - Hemoglobin 13.6 g/dL (L) Monocytes 14.3% (H) Monocytes 1.0 x10(3)/mcl (H). See patient records for details of neurodiagnostic studies.	MIL	MIL	ZITHROMAX; SUDAFED; MUCINEX; TYLENOL (initiated after vaccine administration, but prior to Adverse event)		None; NKDA			1						1	Abasia; Asthenia; Ataxia; Balance disorder; Bilirubin urine; Blood culture negative; Blood product transfusion; Bronchitis; C-reactive protein increased; CSF culture negative; CSF glucose normal; CSF lymphocyte count normal; CSF monocyte count; CSF protein increased; CSF test abnormal; CSF white blood cell count negative; Chest X-ray normal; Computerised tomogram abnormal; Culture stool negative; Disturbance in attention; Dysgraphia; Electromyogram abnormal; Epstein-Barr virus antibody negative; Epstein-Barr virus antibody positive; Fall; Gait disturbance; Glucose urine absent; Gram stain negative; Guillain-Barre syndrome; Hypoaesthesia; Hypokinesia; Influenza serology positive; Nitrite urine absent; Pain in extremity; Paraesthesia; Red blood cell count decreased; Red blood cell sedimentation rate increased; Red blood cells CSF positive; Rehabilitation therapy; Rheumatoid factor negative; Sensory disturbance; Sensory loss; Specific gravity urine; Syphilis test negative; Upper respiratory tract infection; Urine leukocyte esterase; Urobilin urine	FLUN3~MEDIMMUNE VACCINES, INC.~U24791DA~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB162AA~UNK~IM~LA~HEP A + HEP B (TWINRIX)~1|MMR~MERCK & CO. INC.~0008Y~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|MNQ~SANOFI PASTEUR~U2843AA~UNK~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PPV~MERCK & CO. INC.~1679U~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0350602	07/01/2009	NJ				F	06/29/2009	Initial report was received 25 June 2009 from another manufacturer (document number 45220797), who received the report from a health care professional. A female patient had developed Guillain-Barre Syndrome and paralysis of her legs after she had received an unspecified influenza vaccination when she was a child. The patient's recovery status was not reported. No further information was available at the time of the report. Documents held by sender: None.				Y									Not reported	UNK	UNK			Not reported		200902717	1						1	Guillain-Barre syndrome; Monoplegia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0350604	07/01/2009	WA				F	06/29/2009	Initial report received 25 June 2009 from another manufacturer (document number 45220198), who received the report from a consumer, who is the patient. A female patient (age not reported) who had a history of unspecified reactions to many unspecified narcotics, reported that she was allergic to a flu vaccine (manufacturer, lot number and date of administration not reported) and immediately after receiving the vaccine, she came down with an extreme case of the flu. The patient also reported becoming sick after receiving polio vaccine (manufacturer, lot number and date of administration not reported) many years ago. The patient sought medical attention at a doctor's office and subsequently recovered (dates of recovery not reported). Documents held by sender: None.				Y					Y				Not reported	UNK	UNK			The patient had a history of unspecified reactions to many unspecified narcotics.		200902730	1						1	Allergy to vaccine; Immediate post-injection reaction; Influenza; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0348263	07/06/2009	NC	3.0	3		F	06/22/2009	A serious spontaneous report of third nerve palsy, dilated pupil on the right side, loss of vision, eye misalignment and non-serious report of entire dose of FLUMIST being administered in right side has been received from a consumer, patient's mother, in the country concerning a three year-old female subsequent to FLUMIST. Past medical history included a febrile seizure when the patient was 13 months old. No concomitant medications were reported. No previous vaccines were given at the time of FLUMIST. The patient received a dose of FLUMIST on 04-Sep-2008. The dose of FLUMIST was entirely administered in the right nostril. On 07-Sep-2008 the patient was noted to have a blown pupil in the right eye. She was then evaluated by an ophthalmologist and neuro-ophthalmologist. A work-up that included multiple diagnostic testing and CT scans failed to identify a cause. A diagnosis of 3rd nerve palsy was made on Apr-2009. The mother states that the child also was told there was loss of vision in the eye due to misalignment of the right eye. The outcome of the entire of FLUMIST being administered in right side was resolved. All other events remain unresolved. The causality of the events to FLUMIST was not reported.									N	09/04/2008	09/04/2008	0		OTH	OTH	Concomitant Drug(s) Not reported.		No previous vaccines given at time of FLUMIST therapy; Past Disease: Febrile seizure		MEDI0008579	1						2	Angiogram; Antinuclear antibody positive; Apraxia; Blood alkaline phosphatase increased; Blood bilirubin normal; Diplopia; Eyelid ptosis; IIIrd nerve paralysis; Laboratory test normal; Nuclear magnetic resonance imaging normal; Pupil fixed; Pupillary disorder; Strabismus; Thyroid function test normal; Blindness; Eye disorder; IIIrd nerve paralysis; Mydriasis; Wrong technique in drug usage process	FLUN3~MEDIMMUNE VACCINES, INC.~500543P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB289BA~2~IM~LL~HEP A (HAVRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0350818	07/06/2009	MI	68.0	68		F	06/23/2009	Less than one week later sleepiness, weakness. By 2 wk after the vaccination she developed bilat leg weakness and could no longer walk.  She was admitted to hospital 12-6-2008. Was diagnosed with GUILLAIN BARRE syndrome. Follow up received 7/21/2010: She only partially recovered from the Guillain Barre and died at the hospital last year. I do not have access to her chart now and cannot remember the exact date.  8/27/09 Received hospital medical records of 12/6/08-6/23/2009 FINAL DX: acute inflammatory demyelinating polyneuropathy/Guillain-Barre syndrom w/quadriparesis w/respiratory failure, s/p tracheostomy, s/p ventilator, s/p IVIG;  s/p G-tube placement; recurrent UTI due to VRE/Klebsiella; atrial fib s/p pacemaker; acure renal failure, resolved. Records reveal patient experienced acute onset generalized weakness, leg cramps, dyspnea, sleepy, difficulty walking, fall.  Neuro consult done.  Intensive care.  BP dropped, developed dysphagia, atrial fib, areflexic, fever, sepsis, multiple UTIs, decreased mental status, intubated & mech ventilation, bradycardia, DVT right arm,  Tx w/IVIG x 5 doses x 2 courses, blood transfusions, IV antibiotics, pacemaker insertion,  Progress very slow & ultimately d/c to inpatient rehab facility. Principal ICD9 codes: 3570, 34400, 51881, 5990			Y	Y	Y	200	Y		N	10/13/2008	11/25/2008	43	EMG; lumbar puncture; neurology consultation  8/27/09 Medical records received w/LABS: Initial CSF: protein (N).  Initial EMG/NCS c/w diffuse axonal demyelinating neuropathy of sensory & motor.  Initial labs: sodium (L), potassium (L).  Blood c/s (+), sputum c/s (+)CT neg.  Brain MRI/MRA c/w old stroke	OTH	PVT		None	Hypertension; T2 DM; atrial fibrillation; CHF  8/27/09 Medical records received w/PMH: hypothyroidism; dyslipidemia; obstructive sleep apnea; s/p gastric bypass Roux-en-Y; overweight			1						1	Abasia; Asthenia; Blood pressure decreased; Death; Deep vein thrombosis; Dyspnoea; Endotracheal intubation; Gait disturbance; Gastrointestinal tube insertion; Guillain-Barre syndrome; Immunoglobulin therapy; Lumbar puncture; Muscular weakness; Somnolence; Transfusion	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~881123P~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0345059	07/13/2009		60.0	60		F	06/24/2009	Information has been received from a registered nurse concerning a 60 year old female patient with codeine and cortisone shot allergy and no pertinent medical history reported, who on 22-APR-2009, was vaccinated with ZOSTAVAX (Merck) (Lot # 663202/1730X) 0.65ml, SQ in the morning for shingles and VARIVAX (Merck) (Lot # 664360/0551Y valid for MMR II) in the afternoon for travel at 2 different locations. There was no concomitant medication. On 26-APR-2009, the patient developed wheals on the left side of her abdomen. It was itchy, 4 inches in diameter and painful (pain scale of 2-3). Her rash spread to 12 inches in diameter and localized to the left side of the abdomen. Patient was referred to her primary care physician. The patient is recovering from adverse events. No laboratories were performed. Additional information has been requested.				Y					N	04/22/2009	04/22/2009	0	None	OTH	OTH	None	Drug hypersensitivity			WAES0904USA04565	1						2	Pain; Pruritus; Urticaria; Pain of skin; Pruritus; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89684~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEP~MERCK & CO. INC.~0399X~1~IM~LA~HEP B (RECOMBIVAX HB)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB252AA~1~IM~RA~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~1582X~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PPV~MERCK & CO. INC.~0380U~1~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C3029AA~1~IM~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~055Y~1~SC~LA~VARICELLA (VARIVAX)~1|VARZOS~MERCK & CO. INC.~1730X~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1|VARCEL~MERCK & CO. INC.~~UNK~UN~UN~VARICELLA (VARIVAX)~2|VARZOS~MERCK & CO. INC.~1730X~UNK~SC~UN~ZOSTER LIVE (ZOSTAVAX)~2	USA	Emergency room visit	Influenza
0351203	07/13/2009	CA	69.0	69		F	07/13/2009	This 69-year-old female was brought in by ambulance with a one-day history of trouble eating that she described as difficulty chewing food secondary to lack of sensation in her tongue. She states that her problem started with numbness in her left hip starting around two months ago, which then spread much later to her abdomen and to her upper extremities. She feels that sit is getting worse now in the past ten days where she developed new weakness, balance problems and diminished sensation that spread to her face. The patient states that the trouble walking is secondary to her legs feeling heavy, her right side greater than her left side. She feels also uncoordinated when she walks and notes that the room seems to be spinning sometimes when she  her head. She denies any neck stiffening; only some right-sided muscle aches. Four days prior to admission, she was also in the emergency room for chest pain and otitis externa. Then three days ago, she was diagnosed with a urinary tract infection at the hospital. She states that she had a flu shot in November after which she developed same body aches, fatigue, shortness of breath and some back pain but felt that the symptoms were secondary to the shot. She states that she has a history of loss of control of urination only while coughing and no recent loss of function in the bowel or bladder function. She also relates that in 1998, she had an episode of ptosis which resolved on it's own. She had a Tensilon test at that time which was negative. Otherwise, she also was diagnosed with aspergillus pneumonia for which she sees Doctor and who prescribed PREDNISONE for her, the details of which she does not know.  7/30/09 Hospital records received DOS ER 12/6/01, Inpatient 12/09/01 to 12/20/01. Assessment: Fisher varient Guillain Barre syndrome. Patient presents with trouble eating, difficulty chewing food, lack of sensation in tongue. Numbness in hip, abdomen, and upper extremeties. Weakness, balance problems, diminished sensation that spread to face. Trouble walking, legs feeling heavy, right side greater than left. Room seems to be spinning, right sided muscle aches. Chest pain, otitis external, urinary tract infection. Fatigue, shortness of breath. Slurring speech. No two-point discrimination. Babinski abnormal. Deep tendon reflexes absent. Cerebellar clumsy heel to shin and finger to nose. Thigh pain.			Y	Y	Y	11	Y	Y	N	11/27/2001			White blood cell count 4.1, H&H 13.6 and 40.3, platelets 280, MCV 96, lymphs 37, neutrophils 30, Sodium 136, potassium 3.4, chloride 94, bicarb 33, BUN, creatinine 0.7, glucose 109, ESR 59, ANA pending. UA: Specific gravity 1.01, pH 7.0, no glucose, no blood, no nitrites, small leukocyte esterase. Troponin less that 0.3, CK 50, T-bili 0.6. LFTs normal. EKG shows normal sinus rhythm, bradycardic at 60. CT of the head is negative. Calcium  8.0.  LABS and DIAGNOSTICS: Electrodiagnostic studies abnormal - see pt records for details. Chest X-ray - No active pathology, normal. Abdominal X-ray - Some distention in abdomen. CT Scan Chest - abnormal. X-ray Cervical Spine - WNL. MRI Brain - Negative. MRI Cervical Spine - WNL. CT Head - WNL. CSF - Protein 53.0 mg/dL (H). ANA (-). ESR 59 mm/Hr (H) Urinalysis - Leuk Esterase small. CHEM - Chloride 94 mg/dL (L) CO2 33 mEq/L (H) Potassium 3.3 mEq/L (L). CBC - Granulocytes 30% (L) Monocytes 21% (H) Eosinophil 10% (H). TSH 6.5 uIU/mL (H). Additional serial CHEMs and CBCs - See patient records. Urine  - Polyclonal Light Chains present.	UNK	UNK	MAXIDE, PROTONIX, ENTEX, SINGULAIR, CIPRA, VICODIN, PREDNISONE. MEDS: Maxide, Protonix, Entex, Singulair, Cipro, Vicodin, prednisone.		Past medical history: Gastroesophageal reflux disease, hypertension, sinusitis, aspergillus pneumonia, shingles, urinary tract infection, thrombophlebitis.; Sulfa allergy; Past surgical history: Hysterectomy, right breast biopsy which was benign, and a toe bunion removed.			1						1	Antinuclear antibody; Asthenia; Back pain; Balance disorder; Blood bicarbonate decreased; Blood bilirubin normal; Blood calcium increased; Blood chloride decreased; Blood creatine phosphokinase decreased; Blood creatinine normal; Blood glucose normal; Blood pH decreased; Blood potassium decreased; Blood sodium normal; Blood urea; Chest pain; Coordination abnormal; Dyspnoea; Electrocardiogram normal; Fatigue; Gait disturbance; Haematocrit; Haemoglobin; Hypoaesthesia; Hypoaesthesia oral; Liver function test normal; Lymphocyte count normal; Mastication disorder; Mean cell volume abnormal; Myalgia; Neutrophil count decreased; Otitis externa; Pain; Platelet count normal; Red blood cell sedimentation rate increased; Scan brain; Sensation of heaviness; Specific gravity urine normal; Troponin; Urinary tract infection; Vertigo; White blood cell count decreased	FLUX~UNKNOWN MANUFACTURER~4018034~5~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0351384	07/13/2009		64.0			M	06/24/2009	Information has been received from a registered pharmacist concerning a 64 year old male patient who on 06-MAR-2009 was vaccinated with a 0.65 mL dose of ZOSTAVAX (Merck). Concomitant therapy included influenza virus vaccine (unspecified). On 08-MAR-2009 the patient experienced rash in multiple spots on her body after getting ZOSTAVAX. The patient sought unspecified medical attention. The patient's outcome was not reported. Additional information has been requested.				Y					U	03/06/2009	03/08/2009	2	Unknown	OTH	OTH			Unknown		WAES0903USA02950	1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~UN~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0328059	07/14/2009	NY	11.0	11		M	11/14/2008	Initial information was received on 03 November 2008 from the CDC (Center for Disease Control and Detection), under VAERS reference number 328059-1.  A 11 year old male patient with a history of asthma received an injection of FLUZONE (lot number U2784GA) and ADACEL (lot number UF452CA) on 08 October 2008.  On 10 October 2008 the patient had 8cm of redness around the injection sites the day after vaccines were administered.  Two days after he had swelling of the left side of the face and his eye was swollen shut.  His temperature was 98.7, blood pressure was 118/88.  A urinalysis was normal and a streptococcal identification test was negative.  Treatment included BENADRYL and ORAPRED.  The patient was not recovered at the time of the report.  List of Documents held by Sender:  None.									N	10/08/2008	10/10/2008	2	Urinalysis was normal.  Streptococcal identification test was negative.	UNK	UNK	ADVAIR;  SINGULAIR		The patient had a history of asthma.		200803420	1						2	Eye swelling; Injection site erythema; Streptococcal identification test negative; Swelling face; Urine analysis normal	FLU3~SANOFI PASTEUR~U2784G~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|TDAP~SANOFI PASTEUR~UF452C~UNK~UN~UN~TDAP (ADACEL)~2	USA		Influenza
0328370	07/14/2009	IL	12.0	12		M	11/14/2008	This non-serious case was received from a health professional in the United States on 13 October 2008. A 12-year old female patient, with no reported medical history, received the following vaccines on 13 October 2008: an intramuscular right deltoid injection of (lot number C2767AA), an intramuscular left deltoid injection of MENACTRA (lot number U2618AA), a subcutaneous right arm injection of VARIVAX (Merck, lot number 4051X/1140X), and FLUMIST (Medimmune, lot number 500545P) administered nasally. Additionally the patient's mother had requested that a lead test be performed, and so the patient underwent capillary phlebotomy. Approximately 10 minutes after vaccination, the patient complained of dizziness, lightheadedness, and nausea. She also had one episode of emesis. Pulse oximetry was 98%, and heart rate 78 beats per minute. The event recovered after 30 to 45 minutes, and the patient was able to ambulate to the car with her mother. She had no further complaints. Follow-up information received on 12 November 2008 from a health care professional. The patient had not experienced any adverse event with prior vaccinations. The episode of lightheadedness, nausea and emesis resolved with rest and fluids. The patient experienced no further sequelae. No further information is expected. Documents held by sender: None									Y	10/13/2008	10/13/2008	0	Not reported	UNK	UNK			None reported. From new information received on 12 November 2008, the patient had not experienced any adverse evens with prior vaccinations.		200803196	1						3	Dizziness; Heart rate normal; Nausea; Oxygen saturation normal; Vomiting; Dizziness; Heart rate normal; Nausea; Oxygen saturation normal; Vomiting; Dizziness; Nausea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500545P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|MNQ~SANOFI PASTEUR~U2618AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TDAP~SANOFI PASTEUR~C2767AA~UNK~IM~RA~TDAP (ADACEL)~2|VARCEL~MERCK & CO. INC.~1140X~2~SC~RA~VARICELLA (VARIVAX)~2|FLUN3~MEDIMMUNE VACCINES, INC.~500545P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3|MNQ~SANOFI PASTEUR~U2618A~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~3|TDAP~SANOFI PASTEUR~C2767A~1~IM~RA~TDAP (ADACEL)~3|VARCEL~MERCK & CO. INC.~1140X~2~SC~UN~VARICELLA (VARIVAX)~3|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~5|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~5|MNQ~SANOFI PASTEUR~~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~5|TDAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~TDAP (NO BRAND NAME)~5	USA		Influenza
0329066	07/14/2009		27.0			F	06/03/2009	This serious case was extracted from the VAERS database via QSCAN on 24 February 2009 (VAERS identification number 329066). A 27-year-old female patient, whose past medical history was not provided, had received on 15 October 2008 a first intramuscular injection of ADACEL (lot number C2689AA); and an intramuscular injection of FLUZONE SV 2008-2009 (lot number U2756AA). The sites of administration for both vaccines were not provided. Approximately 10 minutes post-vaccination (also reported as 31 days post-vaccination on 15 November 2008), the patient developed hives, red eyes, itching, cough and scratchy throat. The patient presented to the emergency room and was administered 0.2 mL of Epinephrine 1:1000 at 11:21am, and BENADRYL 25mg (IV) at 11:25am, and oral BENADRYL 50mg at 11:50am. The patient's vital signs were stable throughout and she was discharged to home at 12:20am in stable condition. The patient recovered (date not provided). Documents held by sender: None.									Y	10/15/2008	10/15/2008	0	Not reported	UNK	UNK			Not reported		200900697	1						2	Cough; Ocular hyperaemia; Pruritus; Throat irritation; Urticaria	FLU3~SANOFI PASTEUR~U2756A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|TDAP~SANOFI PASTEUR~C2689AA~1~IM~UN~TDAP (ADACEL)~2	USA		Influenza
0351851	07/14/2009	NJ	60.0	60		M	12/23/2008	This non-serious case was received from a physician on 08 December 2008. A 60-year-old male patient, with no reported medical history, received an injection of ADACEL (lot number UF456CA / C3005) and FLUZONE SV 2008-2009 (lot number U2810AA) on 04 December 2008. Approximately five hours after vaccination, the patient developed a dry, hacking cough. The physician was going to prescribe cough medicine (unspecified). Outcome was not reported. Follow-up information was received 22 December 2008 from a health care professional. ADACEL was administered intramuscularly in the right deltoid and FLUZONE SV was administered intramuscularly in the left deltoid. The reporter kept in touch with the patient by telephone and reported that the symptom off cough subsided five to six hours after onset. The reporter spoke with the patient that evening and following - patient felt fine. The patient recovered from the event. No additional information was provided.									Y	12/04/2008				UNK	UNK			None reported.		200803914	1						1	Cough	FLU3~SANOFI PASTEUR~U2810A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C3005~UNK~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0351855	07/14/2009	TN				F	03/18/2009	Initial report received from a healthcare professional on 08 December 2008. An adult female patient (age not reported) received a first intramuscular deltoid injection of ADACEL (lot number C3027BA) and a first intramuscular left deltoid injection of FLUZONE (lot number U2761AA) on 23 September 2008 and the following day, she developed a local reaction described as swelling, fever and sore arm. No diagnostic tests or lab data were performed. The patient received treatment symptomatically and recovered. No additional details were reported. Follow-up information received on 09 February 2009 from a health care professional. The injection site swelling was approximately one inch. According to the reporter, the events resolved in five to seven days.  Follow-up information received 16 March 2009 from a health care professional. The reporter verified that the patient's right arm had been sore. ADACEL had been administered in the patient's right deltoid and FLUZONE was administered in the left deltoid and it had been greater than two years since the patient last received a Td booster. Corrective treatment consisted of a compress and exercise. No further information was provided. This patient's case was created as the result of follow-up received for a cluster of six patients. The other five patients were also identified and are recorded in cases 2008-02996, 2008-03924, 2008-03925, 2008-03926 and 2008-03923, all from the same reporter.  Documents held by sender: None.									Y	09/23/2008	09/24/2008	1	None	PVT	UNK			Not reported.		200803927	1						1	Injection site swelling; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U2761A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C3027B~1~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0351859	07/14/2009		58.0			F	03/04/2009	This non serious case was received on 24 February 2009 from VAERS (reference number 331469) via a search of the agency database. A 58 year old female received an intramuscular injection of ADACEL (lot number not reported, FLUZONE (lot number U2744AA, and PNEUMOVAX (manufacturer Merck, lot number not reported) on 23 October 2008. On that day, the patient complained of a cough, chills, her throat closing up, eye drainage, blood shot eyes, and a possible fever. She took TYLENOL for her symptoms. A local site reaction was not reported. The patient was reported as recovered. List of Documents held By Sender: None.									Y	10/23/2008	10/24/2008	1	None	OTH	OTH			None		200900716	1						1	Chills; Cough; Eye discharge; Ocular hyperaemia; Throat tightness	FLU3~SANOFI PASTEUR~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~~UNK~IM~UN~TDAP (ADACEL)~1	USA		Influenza
0351860	07/14/2009		42.0			F	03/04/2009	This case was extracted from the VAERS database via QSCAN on 24 February 2009 (reference number 332974). A 42-year-old female patient received intramuscular injections of ADACEL (lot number C2774AA) and FLUZONE SV 2008-2009 (lot number U2744AA) on 05 November 2008. Later that day, she began experiencing itchy eyes and a persistent, productive cough. Her eyes became red and puffy, cheeks flushed, face puffy, lips swollen, and chest red, warm and itching. She later complained of a headache, fever, chills, and body aches. She took one Ibuprofen and treated the swelling with ice chips. She did not seek medical treatment. A doctor's appointment was reportedly scheduled for 06 November 2008, however no details were provided regarding this appointment. Outcome was not provided.									U	11/05/2008	11/05/2008	0		UNK	UNK					200900738	1						1	Chills; Erythema; Eye pruritus; Eye swelling; Flushing; Headache; Lip swelling; Ocular hyperaemia; Pain; Productive cough; Pruritus; Pyrexia; Skin warm; Swelling face	FLU3~SANOFI PASTEUR~U2744A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C2774AA~UNK~IM~UN~TDAP (ADACEL)~1	USA		Influenza
0351862	07/14/2009		26.0			F	03/03/2009	This case was extracted from the VAERS database via OSCAN on 24 February 2009 (reference numbers 336106 and 335552). A 26-year-old female patient received intramuscular injections of Fluzone SV 2008-2009 (lot number U2848AA) and Adacel (lot number C3027AA) on 17 December 2008. One hour post-vaccination, she developed red eyes, a cough, and was stopped up. She was instructed to report to the emergency department for evaluation; no additional information was reported.										12/17/2000				UNK	UNK					200900754	1						1	Cough; Ocular hyperaemia; Respiratory tract congestion	FLU3~SANOFI PASTEUR~U2848A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C3027A~UNK~IM~UN~TDAP (ADACEL)~1	USA		Influenza
0351968	07/14/2009	NC	54.0	54		F	11/25/2008	Initial information was received on 27 October 2008 from a health care professional. A 54 year old female received an intramuscular left deltoid injection of FLUARIX (manufacturer GSK, lot number AFLUA3808AA) on 21 October 2008. On 22 October 2008 she received an intramuscular left deltoid injection of ADACEL (lot number C3030AA) and TWINRIX (manufacturer GSK, lot number AHABB132AC) given in the right deltoid. The patient noted that she received the Td injection in 2003. On 23 October 2008 the patient had a big local reaction at the injection site (arm not specified). The patient also had an indurated area which was red, swollen and measured at 7.25 x 7.5 cm. The patient stated that at one point it was larger than 7.25 x 7.5 cm. The patient was seen by her physician. The patient was not recovered at the time of the report. Follow-up information received on 24 November 2008 from a health care professional. The patient's reaction was at the site of the ADACEL injection in the left deltoid. She was re-evaluated in the clinic on an unspecified date and treated with over the counter ADVIL and warm soaks. She recovered from the events on 04 November 2008. List of Documents held by Sender: None.				Y					Y	10/22/2008	10/23/2008	1	None reported.	OTH	OTH			None reported.		200803357	1						1	Injection site erythema; Injection site induration; Injection site swelling; Local reaction	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA380AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB132AC~UNK~UN~RA~HEP A + HEP B (TWINRIX)~1|TDAP~SANOFI PASTEUR~C3030A~UNK~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0351415	07/15/2009	NE	16.0	16		M	07/07/2009	Severe nausea; weight loss over 20 lbs; dizziness; balance problems; impaired concentration; vertigo; inflammation of esophagus; abdominal pain, especially 30 minutes to 1 hour after meals; difficulty with speech articulation, impaired short term memory/recall; bilateral hand tremors; extreme fatigue; shortness of breath.  7/29/09 Consultant medical records received DOS 6/30/09. Assessment: Cerebellar tonsillar ectopia. Patient presents with headaches, dizziness, nausea, weight loss, fatigue, and low-lying cerebellar tonsils. Lack of endurance when running. Can hear pulse in ears. Balance disturbance. Occasional high blood pressure. Nausea and pain after meals. Fasciitis. Vertigo.			Y	Y	Y				N	12/30/2008	01/05/2009	6	Numerous - labs normal; brain MRI essentially normal per neurosurgeon; gall bladder HIDA scan essentially normal; colonoscopy normal.  LABS and DIAGNOSTICS: MRI Brain - 3 to 4 mm cerebellar tonsillar ectopia. X-Ray Cervical Spine - Normal flexion and extention.	PUB	PVT	Vitamin C 500 mg daily. 7/29/09 Consultant medical records received DOS 6/30/09. Prilosec and vitamin C.	Had cold dx but deemed stable for flu shot 12/30/08	Exertional compartment syndrome - bilateral fasciotomy. 7/29/09 Consultant medical records received DOS 6/30/09. Compartment syndrome of legs - fasciotomies. Ear tubes. Allergic esophagitis possibly to dairy products.			1						1	Abdominal pain; Amnesia; Balance disorder; Colonoscopy normal; Disturbance in attention; Dizziness; Dysarthria; Dyspnoea; Fatigue; Hepatobiliary scan; Laboratory test normal; Memory impairment; Nausea; Oesophagitis; Tremor; Vertigo; Weight decreased	FLU3~SANOFI PASTEUR~U2849AC~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0351887	07/20/2009	NV	1.0	0	1	M	06/30/2008	Loss of eye contact, words, repetitive odd behaviors, crying, sick, diarrhea. Pt was given 18 vaccines until 18 months. Pt was born with a twin-his sister is NT. At birth swallowed fluid-mild pneumonia- given antibiotics and Hep B- another Hep B 2 months later- more vaccines- MMR, Flu, chicken pox all given 11-3-06. (5 vaccines in total notice next month patient lost all skills, words, etc...   7/21/09 Medical records received DOS 11/14/05 to 6/20/08. Assessment: Not verbal. Patient presented with coughing, wheezing. Speaks single words. Reluctant to make eye contact at times. Later not verbal / sign communication. Blisters in mouth - apthous ulcers. Fever. Autism (per mother).				Y				Y	U	11/03/2006	11/03/2006	0	Regressive autism - GI issues. 7/21/09 Medical records received DOS 11/14/05 to 6/20/08. LABS and DIAGNOSTICS: Stool Cultures (-)	PVT	OTH		none, other than immune, born with compromised immune system (swallowed fluid-given antibiotics and Hep B in delivery room	no. 7/21/09 Medical records received DOS 11/14/05 to 6/20/08. Nasal congestion. Ear infection. Poor sleep.	Hep B~Measles + Mumps + Rubella (no brand name)~1~1.00~Patient		1						1	Abnormal behaviour; Autism; Childhood disintegrative disorder; Crying; Diarrhoea; Gastrointestinal disorder; Malaise; Social avoidant behaviour	FLUX~UNKNOWN MANUFACTURER~~3~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~3~UN~UN~HEP B (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~3~UN~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~2~UN~UN~VARICELLA (NO BRAND NAME)~1	USA	Disabling	Influenza
0351888	07/20/2009	NJ	21.0	21		M	07/15/2009	Developed GUILLAIN BARRE Syndrome - MILLER FISHER Syndrome after multiple vaccinations in Basic Training. Symptoms: Neuropathy, Weakness, Hypo-reflexia, Headache, Migraine, Muscle Pain.  7/27/09 Multiple records received including hospital records and f/u consults. Hospital DOS 4/3-6/09 with D/C DX:  Miller-Fisher variant of Guillain-Barre Syndrome.  Pt presented with c/o weakness in legs, lower back pain and stumbling gait as well as diplopia, dysarthria, paresthesias of the fingertips.  PE (+) for  facial nerve paresis, leg weakness, wide-based gait, ataxia with absent DTRs. Tx with IVIG with partial resolution of sx. Transferred to rehab with continued H/A and back pain.					Y	3			N	02/25/2009	03/27/2009	30	Autoantibodies positive indicating Miller Fisher Variant. See attached. See attached note. Labs and Diagnostics: MRI brain (+) for sinus thickening.  LP WNL.	MIL	MIL	See attached	None but URI following vaccination, see attached	None PMH:  URI at time of vax			1						1	Asthenia; Autoantibody positive; Guillain-Barre syndrome; Headache; Hyporeflexia; Migraine; Miller Fisher syndrome; Myalgia; Neuropathy peripheral	FLUN3~MEDIMMUNE VACCINES, INC.~500589P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB160AA~UNK~UN~UN~HEP A + HEP B (TWINRIX)~1|MNQ~SANOFI PASTEUR~U2846AA~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C3057AA~UNK~UN~UN~TDAP (ADACEL)~1	USA	Hospitalisation	Influenza
0351918	07/20/2009	IN	17.0	17		F	07/20/2009	none									Y	05/07/2009			none	UNK	UNK	none	none	none			1						1	Inappropriate schedule of drug administration	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B073AA~6~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U2831AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1130X~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2911AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~0339Y~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0352240	07/23/2009	TX	15.0	15		F	07/22/2009	This case was received from a health professional on 10 July 2009, and involves a subject enrolled in an investigator-sponsored study. Subject ID: 1-08-08925. A 15-year-old female subject, with a history of appendectomy, received an injection of FLUZONE SV 2008-2009 (lot number U2849AC) on 20 November 2008. At the time of vaccination, she was confirmed to be 8 weeks pregnant; date of last menstrual period was 15 September 2008. Prior to vaccination, on 16 November 2008, the subject had presented to the emergency room with complaints of spotting bright red blood and pain on urination. Physical exam revealed suprapubic tenderness and left costal-vertebral tenderness, and urine analysis was consistent with a urinary tract infection. A transvaginal ultrasound revealed a viable fetus with a fetal heart rate of 150 beats per minute. The subject was given the discharge diagnosis of healthy pregnancy with urinary tract infection, and was prescribed antibiotics. She received study vaccine on 20 November 2008. On 17 December 2008, 27 days post-vaccination, the subject presented to the hospital with a three-day history of increasing abdominal cramping and spotting. The subject reported that she had never taken the antibiotics prescribed for her urinary tract infection. A transvaginal ultrasound showed no intrauterine pregnancy. Fluid was noted in the uterus, and tissue was present at the os of the cervix. She was discharged home to follow-up with her obstetrician, and final diagnosis was complete spontaneous miscarriage. According to the reporter, the event was not related to FLUZONE. Documents held by sender: None.				Y						11/20/2008	12/17/2008	27		UNK	UNK					200903043	1						1	Abdominal pain; Abortion spontaneous; Drug exposure during pregnancy; Ultrasound scan vagina abnormal; Urinary tract infection; Vaginal haemorrhage; Abdominal pain; Abortion spontaneous; Drug exposure during pregnancy; Vaginal haemorrhage	FLU3~SANOFI PASTEUR~U2849A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U2849AC~UNK~IJ~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0352306	07/23/2009	CA	51.0	51		M	07/23/2009	Suffered a transverse myelitis which resulted in temporary paralysis of legs and on-going loss of sensation of body from above the nipple-line to the bottom of feet.  8/14/09 Hospital records recieved DOS 11/30/2008 to 12/03/08. Assessment: Cervical transverse myelitis unclear etiology, Vitamin B12 deficiency, Possible subacute combined degeneration, Whole body numbness, lower extremity weakness and paresthesia, constipation, Insomnia.   Patient presents with left leg weakness and whole body numbness. Describes 'catch' between shoulder blades. Numbness in thighs that spread both caudally and cephalad. Weakness in both lower extremities. Difficulty standing. Slight edema abdomen. Decreased bilateral sensitivity to pinprick and touch sensation. Paresthesias, burning sensation.  ICD-9 Codes: 341.20 Acute (Transverse) Myelitis NOS, 281.1 Vitamin B12 Deficiency NEC, 336.2 Subacute Comb Spinal Cord Degen/Other Disease, 564.00 Uspecified Constipation, 780.52 Insomia Unspecified. \ksk				Y	Y	9			N	10/03/2008	11/30/2008	58	8/14/09 Hospital records recieved DOS 11/30/2008 to 12/03/08. LABS and DIAGNOSTICS: MRI Spine - Abnormal cervical and thoracic spine. MRI Brain - Normal. CBC - HCT 39.9% (L) RDW 11.4% (L). CFS - Protein 73 mg/dL (H).	UNK	UNK		None/experienced flu-like symptoms approx 2 wks after vaccination	None. 8/14/09 Hospital records recieved DOS 11/30/2008 to 12/03/08. Low back pain with radiation of pain and numbness down right lower extremity, heaviness, pins and needles sensation. Left knee arthroscopy for meniscal tear. Seasonal allergies. Left thumb surgery for injured tendon. Left ankle surgery for spurs.			1						1	Diplegia; Myelitis transverse; Sensory loss	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0352393	07/24/2009	OK	57.0	57		F	07/24/2009	I received a flu shot at this clinic on Nov 9, 2007 and 2 weeks later my hands started becoming numb, then my arms and by the next morning my legs were. I became very unstable on my feet, decided to go to the emergency room. I could not even lift my legs or arms to dress myself at this point so a family member hadto dress me. When I reached my front door, my legs gave out and I collapsed. Not able to stand back up, my husband called 911. In the emergency room I was given many test and a Neurologist was called in. He gave me some test and said I had Guillain Barre Syndrome. He gave me some sort of infusions in my IV to start reversing the adverse reactions of the GBS {18 bottles of this, I think} given only at night. I was in the hospital 23 days, receiving therapy daily. After being discharged from the hospital, I had in home therapy because of the paralysis to learn to sit, stand then walk all over again. I couldn't do much of anything for myself for literally about 5 months.  8/24/09 Hospital records recieved DOS 11/21/07 to 12/02/07. Assessment: Guillain-Barre. Acute inflammatory demyelinating polyradiculoneuropathy. Peripheral Neuropathy. Gastrointestinal reflux disease. Insomia. Obesity. Dependent on assistance for activities of daily living. Melanosis coli from chronic laxative use.  Patient felt her body start to tingle, weakness, could not stand up. Presents with difficulty with speech and vision. Tingling in hands. Rapid ascending paralysis, areflexia, and upper respiratory tract infection. IV immunoglobulin administered. C/O pain and anxiety. No bowel movement and has not slept for 11 days. Throbbing leg and back pain.				Y	Y	23			U	11/09/2007	11/22/2007	13	EMG { not sure of all the other test they gave me} Would have to get hospital records. 8/24/09 Hospital records recieved DOS 11/21/07 to 12/02/07. LABS and DIAGNOSTICS: Sed Rate 26 mm/hr (H). CT Head - Chronic Polysinusitis. MRI Brain - Chronic Sinusitis. MRI Cervical Spine - Multilevel Spinal/Foraminal Stenosis. Serum Protein Electrophoreses - Polyclonal increase in gamma globulin. Serum free chain study suggests polyclonal immunoglobulins and/or renal impairment. Neurodiagnostic Studies - Abnormal. Cerebropinal Fluid - Mononuclear cells are present, RBC 185 RBC/cumm (H). Echocardiogram - Normal. Carotid Duplex Imaging - No significant abnormality of flow. CBC - WBC 12.0 k/cumm (H) Hematocrit 44.7% (H) Neutrophils 79.1% (H). Urinalysis - Blood Trace Abnormal. Hemoglobin A1C (Glycosylated) 6.60 (H).	UNK	UNK			8/24/09 Hospital records recieved DOS 11/21/07 to 12/02/07. Obesity. Bilateral vein resection with hysterectomy. Retinal detachment treated with laser therapy. Smokes.	N/A~ ()~~0.00~Patient|N/A~ ()~~0.00~Sibling|N/A~ ()~~0.00~Sibling		1						1	Activities of daily living impaired; Dysstasia; Electromyogram; Gait disturbance; Guillain-Barre syndrome; Hypoaesthesia; Hypokinesia; Paralysis	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0352452	07/24/2009	SC	0.7			M	07/24/2009	This case was reported by a pharmacist and described the occurrence of jaundice in an infant male subject whose mother was vaccinated with FLUARIX (GlaxoSmithKline). The reporter was the subject's mother. On 5 November 2008 the subject received unspecified dose of FLUARIX (transplacentary at 21 weeks gestation). The subject was born at 38 weeks gestation with no birth defects noted via cesarean section. The infant weighed nine pounds, 12 ounces, was 20.5 inches in length and had APGAR scores at one minute and five minutes of less than seven (exact score unknown). The infant had no respiratory problems. At an unspecified time after receiving FLUARIX transplacentary, the subject experienced jaundice. The reporter did not consider the jaundice to be serious. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.									U	11/05/2008			UNK	PUB	PVT		Unknown			A0758212B	1						1	Caesarean section; Drug exposure during pregnancy; Neonatal disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0339119	07/27/2009	MA	86.0			M	07/24/2009	This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. It was reported that an 86 year old male with no pertinent medical history reported and no known drug allergies was vaccinated SC into the left arm with first dose of ZOSTAVAX (Merck) (lot number 663637/1705X) on 02-FEB-2009. Secondary suspect vaccination included first dose of PNEUMOVAX 23 (route: intramuscular, left arm, lot number 662020/0614X). Concomitant vaccination given on the same date included first dose of FLUARIX (route: intramuscular, left arm lot number AFLLA165AA). It was reported that the above mentioned patient died on 06-FEB-2009. The family called on 10-FEB-2009 to report the death. The patient died of a brain hemorrhage. On 13-MAR-2009, records were received for date of service from 06-FEB-2009: the patient presented with a two day history of lethargy. Upon arrival, the patient was oriented and then had an acute descompensation and was intubated. The patient had an Anterior Inferior Cerebellar Artery aneurysm rupture on 04-FEB-2009 or before. The family declined surgical or IR intervention. The patient experienced bradycardia. He did not response to voice or sternal rub. He had no cough or gag reflex. The patient was asystole. A CT scan performed on an unspecified date showed diffuse subarachnoid hemorrhage (SAH). It was reported that the patient recently moved to the country. On 24-MAR-2009, the discharge summary was received: the diagnosis was subarachnoid hemorrhage. Information received on 14-APR-2009 showed that the cause of death was subarachnoid hemorrhage. Aneurysm rupture. The listing indicated that one or more of the events resulted in death. No further information is available. This was originally reported by a consumer. The VAERS ID number is 339119. A standard lot check investigation was performed for lot numbers 663637/1705X and 662020/0614X. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lots met the requirements of the Center and were released.	Y	02/06/2009							N	02/02/2009	02/03/2009	1	Computed axial, showed diffuse subarachnoid hemorrhage	OTH	OTH			None		WAES0907USA01916	1						3	Anorexia; Asthenia; Fatigue; Lethargy; Cerebral haemorrhage; Death; Acute respiratory failure; Aneurysm ruptured; Bradycardia; Cardiac arrest; Cerebral haemorrhage; Computerised tomogram abnormal; Death; Endotracheal intubation; Intracranial aneurysm; Lethargy; Subarachnoid haemorrhage; Unresponsive to stimuli	FLUX~UNKNOWN MANUFACTURER~AFLLA165AA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0614X~1~IM~LA~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~A41705X~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA165AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~2|PPV~MERCK & CO. INC.~0614X~1~IM~LA~PNEUMO (PNEUMOVAX)~2|VARZOS~MERCK & CO. INC.~1705X~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~2|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA165AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~3|PPV~MERCK & CO. INC.~0614X~1~IM~LA~PNEUMO (PNEUMOVAX)~3|VARZOS~MERCK & CO. INC.~1705X~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~3	USA	Results in Death	Influenza
0352565	07/27/2009	OK	77.0	77		F	07/07/2009	This case was reported by a physician and described the occurrence of swelling injection site in a 77-year-old female subject who was vaccinated with (FLULAVAL, GlaxoSmithKline). Concurrent medications included (ZOCOR), (COUMADIN), (DIGITEK), (ACTONEL), (CLARITIN), (PRILOSEC) and Potassium salt (Potassium). On 23 June 2009, the subject received a dose of FLULAVAL (.1 cc, unknown, left arm). On 23 June 2008, less than one day after vaccination after vaccination with FLULAVAL, the subject experienced swelling injection site, arm pain, headache, dizziness, injection site redness, swelling arm and wrong vaccine administered. At the time of reporting the events were unresolved. The physician considered the events were probably related to vaccination with FLULAVAL. The subject was administered the FLULAVAL vaccine in error and the home health nurse administered the vaccine in the subject's arm. The subject returned to the physician's office today complaining of headache and dizziness as well as a swollen, sore arm and the arm is red at the injection site. Physician had no detailed information regarding lot number or expiration date information. Physician does not believe that the subject has had a similar reaction to previous flu shots in the past. 10/07/2009 Follow up received from the reporting physician 27 July 2009: The subject received FLULAVAL intradermally instead of intramuscularly (intramuscular formulation administered by other route). She was supposed to get PPD TB test. The events improved on 30 June 2009. The physician considered the events could have been associated with erroneous administration.				Y					N	06/23/2009	06/23/2009	0	There were no laboratory or dignostic tests.	OTH	OTH	Simvastatin; Warfarin sodium; Digoxin; Risedronic acid; Loratadine; Omeprazole; Potassium salt		The subject had previously received influenza vaccinations and no adverse events were reported. No adverse events were reported following receipt of prior immunizations.		A0794688A	1						1	Dizziness; Headache; Injection site erythema; Injection site swelling; Oedema peripheral; Pain in extremity; Wrong drug administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~ID~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0352571	07/28/2009	PA	1.2	1	.2	M	07/21/2009	Shingles on 7/19/09.  - Acyclonir				Y					U	11/20/2007	07/19/2009	607		PVT	UNK			Premature 25 wks.			1						1	Herpes zoster	FLU3~SANOFI PASTEUR~U2481EA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB206CA~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0414U~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0352633	07/28/2009	CA	3.0	3		M	07/28/2009	L lateral upper extremity with ~ 4 cm area of blanching erythema with smaller area firmness palpated subcutaneously directly below.									Y	10/28/2007	10/29/2007	1		PVT	UNK	none	none	none			1						1	Injection site induration	FLU3~SANOFI PASTEUR~Lot # U2498AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0352739	07/30/2009	AZ	67.0	67		M	07/19/2009	May 26, 2007 couldn't walk right - took him to ER they admitted him to hospital at that time. his condition kept getting worse - May 28, 07 he went Code Blue - twice - had ventilator put in and on oxygen - totally paralyzed from that time on. Approx 1 1/2-2 wks later had a spinal tap, found he had GUILLAIN BARRE Syndrome. He couldn't move talk nothing.  8/5/09 MR received for DOS 5/26-6/13/07 with D/C DX: Guillaine Barre Syndrome. Pt presented with arm and leg numbness/weakness. PE (+) for facial droop, dysarthria, sensation loss, upper and lower extremity weakness and difficulty with ambulation.  Progressed to full respiratory arrest and pt intubated and later trached. PEG tube placed. Still very weak and unable to lift arms/legs.  Transferred for intensive rehab.			Y	Y	Y	240		Y	N	03/16/2007	05/26/2007	71	Labs and Diagnostics:  Head CT (-). EEG abnormal.  EMG c/w post-infectious neuropathy/GBS.  CSF glucose 120.  CSF protein 64.  CSF cx (-). Sputum (+) for staph aureus. MRI brain (-).  CXR (+) infiltrates.	PVT	OTH		high BP	Blind in left eye; loss of hearing left ear; High BP. PMH:  COPD, high cholesterol. HTN.  back surgery.			1						1	Aphasia; Gait disturbance; Guillain-Barre syndrome; Lumbar puncture abnormal; Mechanical ventilation; Paralysis	FLU3~SANOFI PASTEUR~U22848AA~2~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0352804	07/30/2009	CA	60.0	67		M	07/30/2009	10 days after injection, chronic urticaria. For date... one year, 8 mo.									N	11/06/2007	11/15/2007	9	Blood; Bone marrow bio; Urine; Scans (All neg.	OTH	PVT	(Alleged after event) NEXIUM; AMBIAN	None	None - BPH			1						1	Biopsy bone marrow normal; Blood test normal; Scan; Urine analysis normal; Urticaria chronic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80435~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0352898	07/31/2009	CO	35.0	35		F	07/31/2009	Received the injections in my left arm and had symptoms for over 3 months after the injection. I could not lift my left arm above my shoulder, had numbness and tingling down my arm, fingers and my left leg down to my toes. The left side of my back felt hot to the touch. All these symtoms lastest the entire 3 months.				Y					Y	01/10/2009	01/10/2009	0		UNK	UNK	None	None	None			1						1	Feeling hot; Hypoaesthesia; Injected limb mobility decreased; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~89994~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TDAP~SANOFI PASTEUR~UF45AA~1~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0343265	08/03/2009	AZ	18.0	18		F	08/03/2009	Fainted after about 2 or 3 min the vaccines were administrated. She was sitting at the Dr's high examination bed. Fall down, hit her head and mouth, broke one tooth and another front tooth died. CT scan was performed to check for head injuries (negative). Immune system was affected after the adverse event. From tooth injury she has been treated either by Dentist and Oral Surgeon specialist every week after the incident. She was hospitalized in June 14th for 2 days with a severe tooth infection high temperature 103/104 face swollen from broken tooth. Another CT scan was performed to detect bacteria in dangerous body places (negative) intravenous Morphine and another strong pain medication was administrated for the Hospitalization and follow after with pills. She was release from Hospital June 16th and is currently under treatment, she will required a tooth implant after bone (tooth was subtracted) recovers from severe bacteria damage.				Y	Y	2			Y	06/14/2009	06/14/2009	0		UNK	UNK	NA	NA	Seasonal asthma and allergies			1						3	Fall; Head injury; Immediate post-injection reaction; Loss of consciousness; Computerised tomogram normal; Fall; Head injury; Laceration; Syncope; Tooth injury; Body temperature increased; Computerised tomogram normal; Fall; Head injury; Immune system disorder; Mouth injury; Swelling face; Syncope; Tooth fracture; Tooth infection	FLU3~SANOFI PASTEUR~U2750AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1312X~3~UN~RA~HPV (GARDASIL)~1|FLUX~UNKNOWN MANUFACTURER~Unknown~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|HPV4~MERCK & CO. INC.~1312X~1~UN~UN~HPV (GARDASIL)~2|FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~3|HPVX~UNKNOWN MANUFACTURER~~3~IM~LA~HPV (NO BRAND NAME)~3	USA	Hospitalisation	Influenza
0353023	08/03/2009	TX	68.0	68		M	08/03/2009	Two days after administration of Vaccine 1/7/09, Patient was discharged and upon arriving at home became incoherent and unresponsive to verbal commands and began shaking.  Patient was taken back to hospital approximately 4-5 hours after discharge.  After admission an MRI was ordered and unsuccessful due to shaking.  Next order was a spinal tap (Lumbar Puncture), cultures were negative for bacteria, a virology was ordered, but results were never released.  The patient was then Intubated and sedated for about 2 weeks to control his shaking an catatonic state.  Doctor diagnosed as Viral Encephalitis.  Patient was then  started on Acyclovir q12h IV, and Zosyn 4.5gm IV q8h with a Dirpivan sedation protocol.  After about 2 weeks from the induced coma, patient slowly regained awareness.  Patient was more coherent and later transfered to a Rehab center for a period of 1-2 week.  Patient has no recollection of incident and has seen a slow but positive progression over the last 7 months.   9/9/09 Hospital records received DOS 1/7/09 to 1/21/09 and 1/21/09 to 2/14/09. Assessment: Viral meningoencephalitis, acute respiratory failure, high-grade fever, electrolyte imbalance, pneumonia, asthma / COPD. Shortly after discharge from prior hospitalization, patient presented with shaking, fever, and confusional state. Agitation. Mechanical ventilation. Cognitive and motor deficits with impairment in mobility, gait, functional communication and cognition. Oral thrush.			Y	Y	Y	14	Y		Y	01/05/2009	01/07/2009	2	Spinal Tap, Bacteria Negative, Virology: no results, MRI/CAT Scan. LABS and DIAGNOSTICS: Spinal Tap - CSF PCR Herpes (-). C diff antigen (+). CHEM - Glucose 191 mg/dL (H) BUN 21 mg/dL (H). Anion Gap 4 (L) Total Protein 5.7 g/dL (L) Albumin 2.3 g/dL (L) A/G Ratio 0.68 (L) Triglycerides 233.0 mg/dL (H) HDL 25.0 mg/dL (L). CBC - WBC 3.8 X10 3 (L) RBC 4.26 X10 6 (L) Hemoglobin 13.0 g/dL (L) Hematocrit 38.7 (L) Lymphocytes# 0.9 X10 3 (L). Urinalysis - Protein Trace, Ketones 40 mg/dL (H). Urine culture - No Growth. Modified Barium Swallow - Normal. EKG - Abnormal, left axis deviation with right bundle branch block. CT Head - Normal.	UNK	UNK	Current Meds: Prednisone 5mg 2tabs po BID,Albuterol 1.25mg 1 vial via neb q4h, Atrovent 0.5mg 1 vial via neb q4h, Darvocet N-100 1 po qid prn, Combivent Inh prn, Dicyclomine 20mg 1 po qd, Glucovance 5/500 1 po bid, Ecotrin 325mg 1 po qd, Im	Swollen Tonsils with elevated White Blood Cell Count, indicative of Infection	Open Heart Surgery 7/2001, Pituitary Surgery 12/2006, Diabetes: Under Control, High Blood Pressure: Under Control. 9/9/09 Prior Medical History - Hospital records received DOS 1/4/09 to 1/7/09. Assessment: Acute sialadenitis, leukoplakia of lower lip, hypertension, coronary artery disease post coronary artery bypass graft, dyslipidemia, type 2 diabetes mellitus uncontrolled, GERD, asthma, dermatosis. Pituitary macroadenoma, pleural effusion, obstructive sleep apnea. Smoker.			1						1	Amnesia; Bacterial culture negative; Catatonia; Coma; Encephalitis viral; Endotracheal intubation; Incoherent; Lumbar puncture; Nuclear magnetic resonance imaging; Tremor; Unresponsive to stimuli	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Hospitalisation	Influenza
0353080	08/04/2009	NJ	23.0	23		F	08/03/2009	Information has been received from a physician concerning a female who in January 2009, was vaccinated IM with the second 0.5ml dose of GARDASIL (lot# not reported). The patient exhibited multiple sclerosis (MS)-like symptoms. The date of onset of the symptoms was unknown. The patient was hospitalized overnight at hospital for testing to rule-out multiple sclerosis. The physician relayed that unspecified test results were non-specific. The dates of hospitalization were unknown. The physician did not provide details of the specific symptoms experienced by the patient but added that the symptoms are improving. Follow up information was received via telephone call from the patient's mother who worked in the doctor's office and was not a Health Professional provided the patient's full name and birth date. It was reported that the patient was 23 year old and had received 2 doses of GARDASIL. The patient received the first dose of GARDASIL from her gynecologist (GYN) physician (date, dose and lot number unknown to reporter). The patient received the second dose of GARDASIL on 12-NOV-2008 (lot# 659184/0843X) (previously reported as January 2009). The patient began having the following symptoms in the middle of December 2008; Swelling in her arm, twitches, constant back pain, could not walk at times. The patient was hospitalized of over night, early in 2009 to rule out (R/O) multiple sclerosis (MS) (hospital name and hospitalization dates not reported). The patient's mother stated that the patient could walk and was improving. Follow up information was received via telephone call from a person from the patient's gynecologist's office who provided the doctor's address and reported that the patient received the first dose of GARDASIL on 05-MAY-2008 (expiration date 14-JUN-2009). Additional information has been requested.   8/7/09 Medical records received DOS 11/12/08 to 7/28/09. C/O heartburn, rosacea, joint stiffness. Second dose of Gardasil administered. Post vaccination patient presents with back pain, insomnia.  8/10/09 Hospital records received, multiple ER and inpatient records DOS 12/26/09 to 1/24/09. Inpatient dates 1/23/09 to 1/24/09. Assessment: Bilateral upper and lower extremity weakness. Patient previously c/o sudden onset of right hand pain, swelling, tingling, bluish discoloration and decreased temperature. Questionable median nerve compression. Patient developed intermittent mild bilateral upper and lower extremity weakness. Knees giving way, back pain in cervical thoracic area. Pronounced left leg weakness. Generalized weakness all extremities. Post epidural and post Dilauded. Right deviation of tongue, dysmetria, hyperreflexia. Cervical epidural injection - local anesthetic nerve block.  8/10/09 Hospital diagnostic procedures DOS 12/26/08 and 1/28/09. Patient presents with right upper extremity pain.   Out patient ICD-9 Codes 453.8 Embolism and Thrombosis of other specified veins, 729.5 Pain in limb.  9/16/09 ICD-9 Codes: 722.0 \ksk				Y	Y	2			N	11/12/2008	12/15/2008	33	Unknown. 8/7/09 Medical records received DOS 11/12/08 to 7/28/09. LABS and DIAGNOSTICS: Mantoux.  8/10/09 Hospital records received DOS 12/26/09 to 1/24/09. LABS and DIAGNOSTICS: MRI Cervical Spine - Right sided predominant disc bulge at C6-C7. CBC - RBC 3.66 pL (L) HCT 38.8% (L) MCV 100.4 fl (H) MCH 34.8 pg (H) Monocytes 3.2% (L) Eosinophil 0.0 /UL (L) CHEM - Sodium 134 mmol/L (L) Calcium 8.2 mg/dl (L) AST 9 U/L (L) ALT 27 U/L (L). CT Head - WNL. X-ray Right Hand and Wrist - No fracture or dislocation. MRI Brain - WNL. Zinc 0.63 mcg/mL (L). Lumbar Puncture -WNL. NCS - WNL. Sonograpy duplex scan of extremity veins - WNL.	OTH	OTH	Unknown. 8/7/09 Medical records received DOS 11/12/08 to 7/28/09. 'B12 pills'	8/7/09 Medical records received DOS 11/12/08 to 7/28/09. C/O heartburn, rosacea, joint stiffness.	Unknown. 8/10/09 Hospital records received DOS 12/26/09 to 1/24/09. B12 deficiency, bipolar disease, asthma. Septoplasty. Alcohol, tobacco use. Fibromyalgia. Sulfa allergy.		WAES0907USA04234	1						1	Abasia; Back pain; Multiple sclerosis; Muscle twitching; Oedema peripheral	FLU3~SANOFI PASTEUR~02926AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0843X~2~IM~RA~HPV (GARDASIL)~1	USA	Hospitalisation	Influenza
0353086	08/04/2009	NY	0.51	0	.5	M	07/29/2009	Intussusception 4 mo after completing 3 doses ROTATEQ. 9/23/09 Medical records received for date of service 7/22/09 to 7/23/09. DX Intussusception with successful reduction by air contrast enema. Sudden onset of abdominal pain and increased irritability.  Nausea & vomiting, bloody BM, minimal intake PO, negative for fever/chills.  Abdomen tender to palpate, firm palpable mass RUQ.   8/20/09 Vaccine records received. Pneumo / Wyeth Prevnar Lot# D33126 IM 2 Previous doses. Administered on 3/27/09 per vaccine records. \ksk  10/1/09 ICD-9 Codes received: 560.0 Intussusception.					Y	2			Y	02/10/2009	07/22/2009	162	09/23/09 Medical Records received for date of service 7/22/09 to 7/23/09 ultrasound: intussusception RUQ. Air contrast enema for reduction of intussusception. Subsequent increase in irritability, repeat U/S revealed reduced intussusception.	PVT	PVT		None	None. 8/20/09 Vaccine records received. Pneumo / Wyeth Prevnar Lot# D33126 IM 2 Previous doses. Administered on 3/27/09 per vaccine records. 9/23/09 Medical records received for date of service 7/22/09 to 7/23/09 Left inguinal hernia repair			1						1	Intussusception	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B167AA~3~IM~UN~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~AVENTIS PASTEUR~UT279GA~1~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF519AA~3~IM~UN~HIB (ACTHIB)~1|RV5~MERCK & CO. INC.~1273X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0228361	08/05/2009	MI	94.0			U	08/02/2009	Initial report received on 27 July 2009 from a literature citation. Purpose: To evaluate a possible association between influenza vaccination and four deaths and four serious illnesses among 114 recent influenza vaccinees in a long-term care facility (LTCF) and two deaths from a nearby physician's office. All had received vaccine from the same lot (Lot A). Methods Field investigation including (1) a retrospective cohort study among LTCF residents who received Lot A or other influenza vaccine, (2) review of medical records of cases of death or serious illness, (3) active surveillance of deaths among 1500 community based Lot A vaccinees and (4) laboratory testing of vaccine from available Lot A vials. Results Medical record reviews showed no common clinical syndrome or cause of death. Laboratory testing of Lot A samples revealed no evidence of tampering and no differences compared to an unrelated lot. The risk of death or hospitalization was not significantly different between persons who received Lot A versus a comparison lot, Lot B (incidence rate ratio (IRR) = 0.9, 95%CI = 0.3-3.3). Conclusions There was no clinical or biological evidence pointing to inherent vaccine safety issues, nor was there a detectable increased risk of death or hospitalization among persons vaccinated with Lot A. Lot specific clustering of adverse events (AEs) may reflect medical events causally unrelated to vaccination. Rapid investigations of potential AEs are important to ensure vaccine safety and to maintain public and healthcare provider confidence in vaccines. A 94 year old patient with a history of CVA, PVD, HTN, hypothyroidism, and partial gastrectomy received FLUZONE SV '2004-'2005 USP (lot number was not provided in article; however, lot number was entered according to the previous info received for the other 4 cases, U1478AA) on an unspecified date. Five days post vaccination, the patient developed a cough. Eighteen days post vaccination the patient died. According to the death certificate, causes of death were respiratory depression, hypoxia, and hypertension. Date of death was not provided. Four additional cases were mentioned in this article that was previously reported to the Company: 2004-03646, 2004-03647, 2004-03648, and 2004-03649.	Y								N					UNK	UNK			History of CVA, PVD, HTN, hypothyroidism, partial gastrectomy.		200903219	1						2	Condition aggravated; Cough; Death; Hypertension; Hypoxia; Respiratory depression; Cough; Death; Hypertension; Hypoxia; Respiratory depression	FLU3~SANOFI PASTEUR~U1478A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|FLU3~SANOFI PASTEUR~U1478AA~UNK~IJ~UN~INFLUENZA (SEASONAL) (FLUZONE)~3	USA	Results in Death	Influenza
0353166	08/05/2009	ID	63.0			F	08/04/2009	Information has been received from the husband of a 63 year old female with heart condition who was vaccinated with a dose of PNEUMOVAX 23 and influenza virus vaccine (unspecified). The patient was hospitalized after receiving the vaccines. The patient's husband reported his wife might be allergic to eggs and the egg component of the vaccines. The husband did not specify the manufacturers of any of the vaccines, however mentioned that she got the vaccines sometime in the 90s. At the report time the outcome was unknown. Additional information is not expected.				Y	Y				U				Unknown	OTH	OTH	Unknown	Cardiac disorder			WAES0907USA04758	1						1	Adverse event	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0353183	08/05/2009					M	08/02/2009	Initial report received on 27 July 2009 from another manufacturer whose initial reporter was a consumer. A unidentified male patient received INFLUENZA VACCINE (manufacturer and lot number unknown) on an unspecified date. Post vaccination the patient developed paralysis for a few months and had Geon Berry disease. The patient stated that he did not want to provide further information because the facility has already documented this information. Recovery status was not reported. List of Documents held by Sender: none.				Y					U					UNK	UNK					200903214	1						1	Guillain-Barre syndrome; Paralysis	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0228347	08/06/2009	MI	78.0			F	08/04/2009	From initial information received on 10/Nov/2004 from the FDA (VAERS # 228347) regarding an adverse event, it was reported that a 79-year-old female patient received a FLUZONE SV '2004-'2005 USP vaccination, lot number U1478AA, administered intra-muscularly in the left arm on 14/Oct/2004. The next day, 15/Oct/2004, the patient experienced a temporary episode of respiratory distress. Three days later, on 18/Oct/2004, the patient developed a fever of 100.5 degrees Fahrenheit, five days later, on 23/Oct/2004, the patient had a fever of 100.5 degrees Fahrenheit and was given oxygen by nasal cannula but was responsive, the fever broke late morning. Oxygen saturations were between 87 and 92%. Later that same day the patient again developed a fever of 102.4 degrees Fahrenheit and developed rapid breathing while on oxygen. Per the nurses' notes the durable power of attorney was called that day and the nurses were instructed that the decision was for no antibiotics be administered to the patient and to maintain the comfort of the patient. The patient was found in her bed without a pulse, blood pressure or respiration at 9:00 PM that evening. The reporter of this case is the same reporter of cases 2004-03646, 2004-03647 and 2004-03649. All four cases came from the same Long Term Care facility. From additional information received on 16/Nov/2004 from an internal e-mail communication from a VAERS nurse researcher, it was reported that the death certificate was received. The cause of death was listed as end-stage dementia. No other information was provided. Additional information concerning this patient was identified on 27 July 2009 from a literature citation. Purpose: To evaluate a possible association between influenza vaccination and four deaths and four serious illnesses among 114 recent influenza vaccinees in a long-term care facility (LTCF) and two deaths from a nearby physician's office. All had received vaccine from the same lot (Lot A). Methods Field investigation including (1) a retrospective cohort study among LTCF residents who received Lot A or other influenza vaccine, (2) review of medical records of cases of death or serious illness, (3) active surveillance of deaths among 1500 community based Lot A vaccinees and (4) laboratory testing of vaccine from available Lot A vials. Results Medical record reviews showed no common clinical syndrome or cause of death. Laboratory testing of Lot A samples revealed no evidence of tampering and no differences compared to an unrelated lot. The risk of death or hospitalization was not significantly different between persons who received Lot a versus a comparison lot, Lot B (incidence rate ratio (IRR) = 0.9, 95%CI = 0.3-3.3). Conclusions There was no clinical or biological evidence pointing to inherent vaccine safety issues, nor was there a detectable increased risk of death or hospitalization among persons vaccinated with Lot A. Lot specific clustering of adverse events (AEs) may reflect medical events causally unrelated to vaccination. Rapid investigations of potential AEs are important to ensure vaccine safety and to maintain public and healthcare provider confidence in vaccines. A 78 year old patient (previously reported as 79 years old) with a history of skin cancer, unexplained weight loss (nine pounds) from September to October 2004. Four days post vaccination the patient developed an intermittent fever. Eleven days post vaccination the patient died. According to the death certificate, cause of death was end stage dementia. No additional information was provided. The following case was also associated with the literature article 2009-03219.	Y	10/23/2004							N	10/14/2004	10/15/2004	1		UNK	UNK	Docusate NA; MIACALCIN; CELEBREX; OSTCAL; ACT FEARS; TYLENOL; Oxygen		The patient's last physical was on 17/Sep/2004, she was on nasal oxygen but was alert. Last PRRS, S2, no murmur. The patient had a past medical history of Dementia, Agitation, Depression, skin cancer and dysphagia and Pneumonia with atelectasis in 2003. The patient had an unexplained 9 lb weight loss from September to October 2004.		200403648	1						2	Death; Dementia; Oxygen saturation decreased; Pulse absent; Pyrexia; Respiratory distress; Respiratory rate increased	FLU3~SANOFI PASTEUR~U1478A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0228348	08/06/2009	MI	69.0			M	08/04/2009	From initial information received on 10/Nov/2004 from the FDA (VAERS # 2283438) regarding an adverse event, it was reported that a 70-year-old male patient received FLUZONE SV '2004-'2005 USP vaccination, lot number U1478AA, administered on 14/Oct/2004. Prior to the patient's flu immunization the patient exhibited a cough on 20/Sep/2004 and on 07/Oct/2004 he began choking and coughing with food. Six days post vaccination, on 20/Oct/2004, the patient's cough became worse and he had developed lung congestion. His blood oxygen was 80-85%, oxygen was 26. The following day, on 21/Oct/2004, the patient's vital signs were temperature 97.4 degrees Fahrenheit, blood pressure 150/80 and blood oxygen was 92% with oxygen. On 21/Oct/2004 hospice care was ordered. On 22/Oct/2004 the patient's vital signs were temperature 99 degrees Fahrenheit, blood pressure 130/70 and oxygen saturation was 90% with three liters of oxygen. At 11am that day the patient was unresponsive. At 5:35am on 23/Oct/2004 the patient expired. According to the nursing director of the nursing facility where the patient expired, an autopsy was not performed on the patient. From the medical records it was reported that the patient experienced under hospice care which had been initiated a few days prior to his death. Lab results were included in the records for a CBC drawn on 24/Oct/2004. The WBC's were 12.2 and the HCT was 40.9. On the day prior to the patient's death his temperature was 101 degrees Fahrenheit. There were no new orders noted for antibiotic therapy. On 22/Oct/2004, the day prior to the patient's death he was started on morphine and ROXANOL. At 5:30am on 23/Oct/2004, no blood pressure, no pulse or respirations were detected. The reporter of this case is the same reporter of cases 2004-03646, 2004-03647 and 2004-03648. All four cases came from the same Long Term Care facility. From additional information received on 16/Nov/2004 from an internal e-mail communication from a VAERS nurse researcher, it was reported that the death certificate was received. The cause of death was listed as end-stage dementia and COPD. No other information was provided. Additional information concerning this patient was identified on 27 July 2009 from a literature citation. Purpose: To evaluate a possible association between influenza vaccination and four deaths and four serious illnesses among 114 recent influenza vaccinees in a long-term care facility (LTCF) and two deaths from a nearby physician's office. All had received vaccine from the same lot (Lot A). Methods Field investigation including (1) a retrospective cohort study among LTCF residents who received Lot A or other influenza vaccine, (2) review of medical records of cases of death or serious illness, (3) active surveillance of deaths among 1500 community based Lot A vaccinees and (4) laboratory testing of vaccine from available Lot A vials. Results Medical record reviews showed no common clinical syndrome or cause of death. Laboratory testing of Lot A samples revealed no evidence of tampering and no differences	Y	10/23/2004							N	10/14/2004	10/23/2004	9	14/Oct/2004: WBC 12.2, MCV 101, MCG 33.4, Neutrophils 26 (decreased), Lymphocytes 60 (increased), Mono 14 (increased), smear suggestive of viral infection (labs ordered 11/Oct/2004).	UNK	UNK	DEPAKOTE; DILANTIN; Aspirin; COLACE; LEXAPRO; Multivitamin; ZANTAC; Vitamin B1; MEGACE; OSCAL; NICOTROL inhaler; TYLENOL; Morphine sulfate; ROXANOL		The patient had a past medical history of dementia, nicotine addiction, emphysema, seizure disorder, anxiety, acute delirium and bipolar disorder. The patient had no known allergies. On 07/Oct/2004, one week prior to the flu immunization, the patient was noted to have increased difficulty swallowing food and was changed to a soft diet. 7 days prior to vaccination the patient was lethargic and had a cough.		200403649	1						2	Body temperature increased; Chronic obstructive pulmonary disease; Condition aggravated; Cough; Death; Dementia; Lymphocyte count increased; Mean cell haemoglobin increased; Mean cell volume increased; Monocyte count increased; Neutrophil count decreased; Oxygen saturation decreased; Pulmonary congestion; Unresponsive to stimuli; Viral test positive; White blood cell count increased	FLU3~SANOFI PASTEUR~U1478A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0327208	08/06/2009		77.0	77		F	07/30/2009	Information has been received from a pharmacist concerning a 77 year old female patient with no medical history who was on 02-OCT-2008 vaccinated with a second 0.5ml dose of PNEUMOVAX 23 (Lot #) in right arm intramuscularly. Her first dose of PNEUMOVAX 23 (Lot # was not reported) was given more than 5 years ago. Concomitant therapy included influenza virus vaccine (unspecified) in left arm. On 02-OCT-2008 the patient experienced arm pain at the injection site in right arm. The patient not recovered. The patient sought medical attention by phone call. Additional information has been requested.									N	10/02/2008	10/02/2008	0	None	OTH	OTH			None		WAES0810USA00554	1						2	Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~IJ~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~0551X~2~IM~RA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0327582	08/06/2009		69.0			F	07/30/2009	Information has been received from a pharmacist concerning a 69 year old female who on 08-OCT-2008 was vaccinated with PNEUMOVAX 23 (dose, route unspecified). Concomitant therapy included influenza virus vaccine (unspecified). Subsequently within a minute or so the patient experienced feeling flushed, dizzy, and felt tingling in her gums and tongue. She sat down for about 20 minutes and the symptoms improved. The patient sought medical attention in the pharmacy. Subsequently, the patient recovered without treatment. Additional information has been requested.				Y					Y	10/08/2008	10/08/2008	0	Unknown	OTH	OTH			Unknown		WAES0810USA01735	1						2	Dizziness; Flushing; Paraesthesia oral	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0328092	08/06/2009	WA	37.0	37		F	07/30/2009	Initial and follow up information has been received from a health care worker and medical records concerning a 37 year old female registered nurse, non smoker, with no allergies. The patient has a history of left ovarian cyst removal, psoriasis and keloid. On 01-OCT-2008 at 12:00PM (previously reported as 30-SEP-2008) the patient was vaccinated with a second dose of PNEUMOVAX (lot # 660717/0224X) 25 mcg/0.5 mL intradermally, instead of tuberculin purified protein derivative (manufacturer unspecified). Concomitant medication included AFLURIA (lot# 02249111A) IM in right deltoid at 12:00PM, CLARITIN D 12 HOUR and Multivitamin (unspecified). There was no illness at the time of vaccination. Subsequently the patient experienced injection site swelling, redness and pain. On 02-OCT-2008 at 12AM, the patient presented to the clinic with chief complaint of a reaction to a tuberculin (TB) test. She stated that her arm was very painful and burning. She had no history of positive purified protein derivative (PPD). Her blood pressure was 140/88 and her temperature was 98.4 degrees. Examination showed that the volar surface of the left forearm revealed a 5 cm area of induration, a 5+cm area of erythema, and 1 cm area of induration in the center. Assessment was positive PPD with probable severe local reaction, cannot rule out early cellulitis. A chest x-ray with indication of positive PPD, was normal. The patient was given a prescription for KEFLEX, to start if erythema continued to spread. On 03-OCT-2008 at 12:00 AM, the patient presented to the hospital with chief complaint of left arm redness, swelling and pain x 2 days that worsened. Since the clinic visit on 02-OCT-2008, she has had associated chills with red streaks up her arm and severe pain and tenderness. The error in the administration of the PNEUMOVAX vaccine rather than tuberculin reagent was discovered late in the afternoon, and she was admitted to the hospital for further treatment. Physical examination revealed a temperature of 36.9, pulse 108, blood pressure 132/60. Integument revealed a well-demarcated, large raised red patch, volar aspect left forearm, with incipient central bullous formation. The area was exquisitely tender. There was red streaking up the arm, coursing toward the axilla. The assessment was left upper extremity cellulitis after inadvertent subcutaneous injection of PNEUMOVAX, with no response to p.o KEFLEX, and systemic symptoms of chills and streaking and incipient bullous formation. Treatment included observation, intravenous Vancomycin 1 g every 12 hrs and IV ceftriaxone 2 g every 12 hrs as well as warm compresses, arm elevation and TYLENOL #3 as needed. On 03-OCT-2003 results from blood culture and culture and sensitivity came back negative and the final report showed no growth after 5 days. Blood differential showed absolute blood monocyte count of 1.0 K/uL (reference ranger: 0.0-0.8). On 05-OCT-2008, the patient had an infectious disease consultation. The physician noted that the patient was also on chewable calcium and antiemetics (unspecified) PRN. During the consult, she was not febrile and both pain and erythema were resolving. The consults impression was left arm cellulitis. The recommendation was to continue the intravenous antibiotics and the patient could be released on 06-OCT-2008 on oral doxycycline for the next few days. She should also continue to apply warm compresses. A vancomycin through done on 05-OCT-2008, came back with a value of 4.8 mcg/mL (reference rang 5.0-15.0). On 06-OCT-2008, the patient was discharged, she had some residual induration at the site of her subcutaneous injection. Her discharge medications included doxycycline 100 mg twice daily. Her discharge diagnosis was left upper extremity cellulitis occurring after inadvertent subcutaneous injection of PNEUMOVAX vaccine with intense, inflammatory reaction. She was to follow up with her primary physician in a week. On 13-OCT-2008, the patient was seen in the clinic. The physician's exam revealed that she had a faint erythematous patch, left volar forearm centrally indurated, mildly tender area, measuring 3-4 cm. The left arm cellulitis was resolving. This is one of two reports received from the same source. Additional information is not expected. All records will be available upon request.					Y	4			N	10/01/2008	10/01/2008	0	Chest x-ray, 10/02/08, normal/clear lungs; Absolute moncyte count, 10/03/08, 1.0 K/uL; Blood culture, 10/03/08, (C&S) Negative/ no growth in 5 days	PVT	PVT	CLARITIN-D 12 HOUR; Vitamins (unspecified)	Non-smoker	Ovarian cystectomy; Keloid; Psoriasis		WAES0810USA00698	1						2	Blood culture negative; Body temperature increased; Chest X-ray normal; Chills; Dermatitis bullous; Inflammation; Injection site cellulitis; Injection site erythema; Injection site induration; Injection site pain; Injection site streaking; Injection site swelling; Monocyte count increased; Tuberculin test positive; Wrong drug administered	FLU3~CSL LIMITED~02249111A~2~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~2|PPV~MERCK & CO. INC.~0224X~2~UN~UN~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0328467	08/06/2009	KY	69.0	69		M	07/30/2009	Information has been received from a pharmacist concerning a 69 year old male who on 04-OCT-2008 was vaccinated with PNEUMOVAX 23. Concomitant therapy included FLUVIRIN. On 05-OCT-2008 the patient experienced left arm was swollen, left arm was tender, injection site reaction and not feeling well. On 06-OCT-2008 the patient experienced left lymph nodes in the neck became swollen. Subsequently, the patient recovered from left arm was swollen, left arm was tender, left lymph nodes in the neck became swollen, injection site reaction and not feeling well. Follow up information was received from the pharmacist who reported that the patient was 68 year old who on 04-OCT-2008 was vaccinated intramuscularly in her left arm with a first dose of PNEUMOVAX 23 (lot# 662100/0742X). Secondary suspect therapy included a dose of FLUVIRIN vaccinated intramuscularly in his left arm on the same day. No illness was reported at the time of the vaccination. One day after vaccination, the patient experienced arm swelling and did not feel well. Two days after vaccination, his arm swelling became more serious and lymph nodes in neck became swollen and the patient felt sick. The patient was told to take BENADRYL. At the time of this report, the patient recovered. Additional information is not requested.									Y	10/04/2008	10/05/2008	1	None	OTH	PVT	Unknown		None		WAES0810USA03917	1						2	Injection site reaction; Lymphadenopathy; Malaise; Oedema peripheral; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89972~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~0742X~1~IM~LA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0328939	08/06/2009	NC	62.0	62		F	07/30/2009	Information has been received from a registered nurse (R.N.) concerning a 62 year old female who on 07-OCT-2008 was vaccinated with a dose of PNEUMOVAX (lot # 660685/0619X).  On 08-OCT-2008 the patient had a softball size, red swollen injection site.  The patient sought medical attention and was diagnosed with cellulitis.  The patient was treated with BENADRYL and antibiotics.  As of 16-OCT-2008, the patient was recovering.  Follow-up information was received from a registered nurse (R.N.).  It was reported that the patient with gastrooesophageal reflux disease, chronic cystitis, diverticulosis, a history of right-sided breast cancer and no illness at time of vaccination who was vaccinated in the left lower deltoid with a first dose of PNEUMOVAX (lot # 660685/0619X) and a first dose of FLUZONE (U28UAA) in the left upper deltoid at 16:00 on 07-OCT-2008.  Both injections were given in left arm due to breast mastectomy.  At 13:00 08-OCT-2008, the patient experienced redness, swelling and pain at injection site, in lower arm after vaccination.  The patient was advised to use cool compress and OTC antihistamine.  Patient's outcome was unknown.  This is one of several reports received from the same source.				Y					N	10/07/2008	10/08/2008	1	Unknown	PVT	PVT	Unknown	Gastrooesophageal reflux disease; Cystitis chronic; Diverticulosis.	Breast cancer.		WAES0810USA03161	1						2	Cellulitis; Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U28UAA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0619X~1~UN~UN~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0330279	08/06/2009		68.0	68		F	07/30/2009	Information has been received from a pharmacist concerning a female with PREDNISONE allergy, SULFONAMIDE allergy and an allergy to strawberries and a history of ulcer who 10 years ago was vaccinated with a first dose of PNEUMOVAX.  The patient received her second dose of PNEUMOVAX on 14-OCT-2008.  Concomitant therapy included ATIVAN.  Subsequently the patient developed an injection site reaction.  The patient was vaccinated with PNEUMOVAX in the right arm where she had swelling at the site and  a line from the site going under her arm.  The patient had been applying ice to the area. The patient's swelling at the site and a line from the site going under her arm persisted.  The patient also received a flu vaccine in the left arm on the same day.  The patient made a phone call to the pharmacist for medical attention.  Additional information has been requested.				Y					N	10/14/2008			None	OTH	OTH					WAES0810USA03230	1						2	Injection site reaction; Injection site streaking; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~IJ~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~~2~UN~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0330749	08/06/2009	PA	32.0	32		F	07/30/2009	Information has been received from a pharmacist concerning a 32 year old female with chronic autoimmune disorder, multiple chemical sensitivities, chronic fatigue syndrome and no known drug allergies who on 17-OCT-2008 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 intramuscularly in the right arm (lot# 661040/0397X). On 18-OCT-2008 the patient went to the ER for generalized body aches. Her right deltoid area had an affected area the size of a baseball that was red, tender to touch, and swollen. Patient was diagnosed with cellulitis and is being treated with BACTRIM DS and KEFLEX. The area has cleared up but the patient is still on the treatment. The patient recovered on an unspecified date. Follow-up information was received. It was reported that the patient was a female film producer with fibromyalgia who was vaccinated intramuscularly with a first dose of PNEUMOVAX 23 in the right deltoid at 16:00 and a first dose of AFLURIA (lot # 01349111A) in the left deltoid at 16:02. There was no illness at the time of vaccination. Reporter stated that the vaccines were given on patient's request. Subsequently, patient experienced pain, swelling and redness at injection site, started within 24 hours, gradually getting worse. Patient used OTC pain medicine and ice to site with no relief. Patient continued to get worse and went to ER on 20-OCT-2008. She developed blow and chills prior to ER visit. She also started with throat swelling. Patient was seen at physician's office on 22-OCT-2008. She still with vaccine site swelling erythema 9x9 cm. On 24-OCT-2008, she developed dry cough and upper symptoms were getting worse. Patient was seen by the physician on 28-OCT-2008, she started with BIAXIN XL 500 mg twice daily. She experienced fever and wheezing cough seen by physician. The symptoms resolved on 04-NOV-2008. No further information is available.				Y					Y	10/17/2008	10/18/2008	1	Unknown	PVT	PVT		Autoimmune disorder; Multiple chemical sensitivity; Chronic fatigue syndrome; Fibromyalgia			WAES0810USA05300	1						2	Cellulitis; Chills; Cough; Injection site erythema; Injection site pain; Injection site swelling; Pain; Pharyngeal oedema; Pyrexia; Upper respiratory tract infection; Wheezing	FLU3~CSL LIMITED~01349111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~2|PPV~MERCK & CO. INC.~0397X~1~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0331132	08/06/2009	VA	2.0	2	.2	F	07/30/2009	Information has been received from a office manager concerning a 26 month old female with allergy to AMOXICILLIN and no pertinent medical history, who on 30-OCT-2008 was vaccinated with PNEUMOVAX (lot # 659150/1384U), 0.5 ml via intramuscular.  Concomitant medication included SINGULAIR.  On 31-OCT-2008 the patient developed fever of 100F and a 3 cm area of swelling of the right thigh 1 day after administration of PNEUMOVAX.  On 31-OCT-2008 the patient was seen in the office and was prescribed ZITHROMAX.  On 01-NOV-2008 the patient was seen again and the reaction had increased to include the entire right thigh.  The patient was continued on ZITHROMAX and was given an injection of ROCEPHIN in the office.  On 04-NOV-2008, an xray of the right thigh and hip revealed possible osteomyelitis.  On 04-NOV-2008, the patient was evaluated and monitored in a hospital emergency room on that day but was not admitted to the hospital.  On 04-NOV-2008 she was released from the emergency room.  On 10-NOV-2008 and 18-NOV-2008 the patient was seen in the office and was recovering.  No further information provided.  Follow up information was received on 20-NOV-2008 which reported:  Caller is the consumer's mother.  On 30-OCT-2008 she stated that her daughter developed a fever on the day that she received the injection.  On 31-OCT-2008 the patient was brought back to the doctor and was given an antibiotic, she also developed  a red circle about the size of a half dollar on her right thigh at the injection site and she was unable to stand on that leg because of the pain.  On 01-NOV-2008 the redness had spread to her groin and down to her knee.  She was brought to a hospital that evening but was not admitted.  While at the hospital, she was diagnosed with cellulitis.  She had a fever that night of 104 degrees.  The red area became hot to the touch and he developed a hard knot at the injection site that grew to the size of a baseball.  On 04-NOV-2008 she went back to the doctor, and was sent to the hospital for an x-ray and blood work.  Her CBC was normal, but her ESR was elevated. The radiologist said that she may have had  osteomyelitis caused by an abscess at the injection site.  On an unspecified date, the patient went to another hospital for another x-ray and an ultrasound.  The doctor confirmed that it was cellulitis, not osteomyelitis.  Presently, the knot is getting smaller and she still complains of pain when it is touched.  Follow up information was reported on 21-NOV-2008:  there was still some swelling and tenderness, so the patient has not yet fully recovered.  This is one of several reports concerning the same source.  Additional information has been requested.				Y					N	10/30/2008	10/31/2008	1	X-ray, 11/04/08, possible osteomyelitis;  X-ray, cellulitis;  Ultrasound, cellulitis;  Erythrocyte, 11/04/08, elevated.	OTH	OTH	SINGULAIR	Drug hypersensitivy			WAES0811USA02920	1						3	Blood culture negative; Differential white blood cell count abnormal; Haematocrit normal; Haemoglobin normal; Injection site cellulitis; Pyrexia; Red blood cell sedimentation rate increased; White blood cell count increased; X-ray limb abnormal; Cellulitis; Dysstasia; Erythema; Full blood count normal; Injection site nodule; Injection site swelling; Pain in extremity; Pyrexia; Red blood cell abnormality; Skin warm; Ultrasound scan abnormal; X-ray abnormal	FLU3~SANOFI PASTEUR~13844~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~UT2794DA~1~IM~RL~PNEUMO (PNEUMOVAX)~2|PPV~MERCK & CO. INC.~1384U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~3	USA	Emergency room visit	Influenza
0332370	08/06/2009	WI	84.0	84		F	07/30/2009	Initial and follow-up information has been received from a registered nurse concerning an 84 year old female with leukemia (stable) at the time of vaccination, anaemia, osteoarthritis, cytopenia, venous insufficiency, allergy to amoxicillin and sulfonamide allergy who in 1997 was vaccinated with the first dose of PNEUMOVAX 23. In 2007, the patient was vaccinated with the first dose of FLUZONE. On 06-NOV-2008 at 9:15 AM, the patient was vaccinated SC (previously reported as IM) in the left deltoid with the second 0.5 ml dose of PNEUMOVAX 23 (lot # 661529/0868X). Concomitant therapy included the second dose of FLUZONE (lot # U2752AA) given in the right deltoid on the same day, prednisone, oxycodone, morphine, cyclobenzaprine HCl (MSD), MIRALAX, ACTONEL, methotrexate, levothyroxine Na, furosemide, PRILOSEC and folic acid. On 07-NOV-2008 at 10:00 AM, the patient experienced a fever with a temperature of 101.5 F, along with redness, swelling, warmth and pain on her arm at the injection site. The affected area on her arm was about 5 cm in circumference. The registered nurse reported in follow up that there was 4 cm x 4 cm red, hot, circular area to PNEUMOVAX 23 injection site. On an unspecified date, the patient recovered from the events. No lab tests were performed. The patient was seen in office and treated with an unspecified antibiotic. This is one of several reports received from the same source. Additional information is not expected.				Y					Y	11/06/2008	11/07/2008	1	None	PVT	OTH	FLEXERIL; folic acid; furosemide; levothyroxine sodium; methotrexate; morphine; PRILOSEC; oxycodone; MIRALAX; prednisone; ACTONEL	Leukaemia; Anaemia; Osteoarthritis; Cytopenia; Venous insufficiency; Penicillin allergy; Sulfonamide allergy			WAES0811USA01102	1						2	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U2752AA~2~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~0868X~2~SC~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0332603	08/06/2009	CO	45.0	45		F	07/30/2009	Information has been received from a Doctor of Pharmacy concerning a 45 year old female with erythromycin reactions and NSAIDs, a history of hospital for gastrointestinal bleed prior to administration of PNEUMOVAX, who on 13-NOV-2008 was vaccinated with PNEUMOVAX (lot # 662263/0743X), 0.5 ml via intramuscular in left arm. Concomitant therapy included FLEXERIL, VICODIN, LIPITOR, PLAVIX, aspirin. On 13-NOV-2008 the patient experienced swelling and redness at the site of injection in left arm for several hours after administration of PNEUMOVAX. The influenza virus vaccine (unspecified) was administered in her right arm the same day as PNEUMOVAX. No additional information was provided. The patient sought medical attention via telephone. No lab diagnostics studies performed. On 14-NOV-2008 the patient was recovered from swelling and redness at the site of injection in left arm. This is one os several reports from the same source. Additional information has been requested.									Y	11/13/2008	11/13/2008	0	Unknown	OTH	OTH	VICODIN; aspirin; LIPITOR; PLAVIX; FLEXERIL; metoprolol	Drug hypersensitivity	Hospitalisation; Gastrointestinal bleeding		WAES0811USA02922	1						2	Injection site erythema; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0743X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0332933	08/06/2009	PA	65.0	65		F	07/30/2009	Information has been received from a 65 year old female patient with fluid retention, drug reaction to codeine and tamoxifen citrate, allergy to molds, trees and grass, and sarcoidosis and medical history of breast cancer 12 years ago who 04-NOV-2008 was vaccinated with a 0.5 ml dose of PNEUMOVAX (Lot # was not available) 0.5cc, intramuscularly on left leg. Concomitant therapy included influenza virus vaccine (unspecified), VALTREX, acyclovir, hydrochlorothiazide (manufacturer unknown), ASTELIN, allergy serum, calcium (unspecified), vitamins (unspecified), guaifenesin, ibuprofen and omega-3 marine triglycerides. On 05-NOV-2008 the patient experienced low grade fever lasted for 2 days and she started to develop cellulitis across the top of her left thigh, 3 inches wide by 7 inches long that later went down on the side of the thigh. Patient noted that her left thigh was inflamed, red, hot and sore. Patient reported that cellulitis stayed for 7 days. There were no laboratory diagnostic studies performed. At the time of the report on 20-NOV-2008, the patient was recovering. The patient sought medical attention with her physician. Additional information has been received from a physician who reported that the patient had facial pain secondary to dental disease, penicillin allergy, sulfonamide allergy and latex allergy. Other concomitant therapy included folic acid, lysine and biotin. On 04-NOV-2008 the patient developed redness and edema of left thigh ( at site of PNEUMOVAX injection). The patient was seen in the office in November 2008 and physician prescribed antibiotics for possible cellulitis, but the patient never took, antibiotics because erythema and edema started to improve. At the time on the report the patient was recovered. Additional information is not expected.				Y					N	11/04/2008	11/04/2008	0	None	PVT	PVT	acyclovir; ASTELIN; biotin; calcium (unspecified); folic acid; guaifenesin; hydrochlorothiazide; ibuprofen; ibuprofen; lysine; omega-3 marine triglycerides; VALTREX; vitamins (unspecified)	Facial pain; Tooth disorder; Fluid retention; Hypersensitivity; Latex allergy; Sulfonamide allergy; Penicillin allergy; Drug hypersensitivity; Sarcoidosis	Breast cancer		WAES0811USA03555	1						2	Cellulitis; Injection site erythema; Injection site inflammation; Injection site pain; Injection site warmth; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~~1~IM~LL~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0333064	08/06/2009	CT	31.0	31		F	07/30/2009	Information has been received from a registered nurse concerning a 31 year old female patient who on 10-NOV-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot#657526/0555U) 0.5ml intramuscularly. Concomitant therapy included FLUVIRIN given on 10-NOV-2008. On 12-NOV-2008 the patient developed redness and cellulitis at the injection site and also had, vomiting and fever. The patient sought medical attention and was treated with KEFLEX. At the time of the report the patient was recovering. Additional information has been requested.				Y					N	11/10/2008	11/12/2008	2	Unknown	OTH	OTH			Unknown		WAES0811USA03750	1						2	Injection site cellulitis; Injection site erythema; Pyrexia; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~0555U~1~IM~UN~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0334113	08/06/2009	IL	49.0	49		F	07/30/2009	Information has been received from a registered pharmacist concerning a 50 year old female patient with shellfish allergy and who on 02-DEC-2008 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 (lot # 662100/0742X). Concomitant therapy included influenza virus vaccine (unspecified). The pharmacist reported that the patient's arm swelled up after receiving the vaccine. The injection site had a big red area. The patient sought unspecified medical attention by calling the pharmacist. At the time of report the patient was not recovered. Additional information has been requested.									N	12/02/2008	12/02/2008	0	None	OTH	OTH		Shellfish allergy			WAES0812USA01597	1						2	Injection site erythema; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0742X~UNK~UN~UN~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0334706	08/06/2009	OH	54.0	54		F	07/30/2009	Information has been received from a registered nurse at the County Health Department, concerning a 54 year old female patient who on 13-NOV-2008 was vaccinated with a dose of PNEUMOVAX (Lot #661577/1161X) . Concomitant therapy included influenza virus vaccine (unspecified) at a separate injection site. Within four hours of receiving the PNEUMOVAX, the patient experienced redness and swelling below the injection site, hives at the injections site and on the top of her feet, and a fever. The patient treated herself with BENADRYL after speaking to the reporter. Patient was recovered by the next morning. Follow up information received from a registered nurse on 26-JAN-2009. It was reported that the patient on 13-NOV-2008 was vaccinated intramuscularly with a first dose of PNEUMOVAX (Lot #661577/1161X) into the left deltoid at 15:30. Concomitant therapy included FLUZONE intramuscularly into the left deltoid. The patient did not have pertinent medical history, no drug reactions/allergies. On 13-NOV-2008 at 18:30, the patient experienced left arm swollen, hives, itching, warm to touch, pain and tenderness all at injection site. The patient took per oral BENADRYL. On 14-NOV-2008, the patient recovered. The patient did not see a physician but reported the symptoms to the office on 17-NOV-2008. Additional information is not expected.									Y	11/13/2008	11/13/2008	0	None	PUB	PVT			None		WAES0811USA03700	1						2	Injection site pain; Injection site pruritus; Injection site swelling; Injection site urticaria; Injection site warmth; Pyrexia; Urticaria	FLU3~SANOFI PASTEUR~U2831AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|PPV~MERCK & CO. INC.~1161X~1~IM~LA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0335853	08/06/2009	TN	49.0	49		F	07/30/2009	Information has been received from a licensed practical nurse (L.P.N.) concerning a 49 year old female who at 11:00 am on 21-OCT-2008 was vaccinated into the left deltoid with a dose of PNEUMOVAX (lot # 656223/1344U).  Concomitant therapy included FLUARIX (lot # UA367EA).  It was reported that on 22-OCT-2008 the patient called and stated that her left side of neck was swollen, her arm where she received PNEUMOVAX and FLUARIX was fine.  She was seen in agency at 1:30 pm on 22-OCT-2008, the left side of the neck was swollen, there was no redness or swelling at the injection site.  It was reported that her neck was sore.  The patient was told to visit a family doctor.  The patient called back on 23-OCT-2008 stated that the family doctor gave her a shot of cortisone and some pain medicines.  The patient was treated with cold compresses for 20 min on neck, then off 10 min, and then back on neck 20 min.  The patient reported that her pain was less and the swelling is going away.  The patient was told by the physician at agency never to take another dose of PNEUMOVAX.  Additional information has been requested.				Y					N	10/21/2008	10/22/2008	1	Unknown	PUB	OTH			Unknown		WAES0903USA03928	1						2	Local swelling; Neck pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~UA367EA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~2|PPV~MERCK & CO. INC.~1344U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0335932	08/06/2009	TN	81.0	81		F	07/30/2009	Information has been received from a licensed practical nurse concerning an 81 year old female patient who on 14-Oct-2008 was vaccinated with her second dose of PNEUMOVAX (lot number 656223/1344U) and FLUZONE (unspecified) into the left deltoid by intramuscular route. Concomitant therapy included influenza virus vaccine (unspecified). On 16-OCT-2008 the patient returned to clinic for swelling, redness and tenderness in left arm, from shoulder to elbow on front side only. The patient then told the nurse she had a reaction six years ago and had forgotten it was from a pneumonia shot. The patient was instructed to put on moist compresses, (comma), TYLENOL for pain and BENADRYL for allergic reaction. The patient was to call the clinic in the morning to relate her progress. It was reported that they were unable to reach the patient for 2 weeks. Additional information has been requested.				Y					U	10/14/2008	10/16/2008	2	Unknown	PUB	PVT	Unknown		Vaccination adverse reaction		WAES0903USA03927	1						2	Hypersensitivity; Injection site erythema; Injection site pain; Injection site swelling	FLUX~SANOFI PASTEUR~UA347EA~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~1344U~2~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0339779	08/06/2009	CA	68.0	68		F	07/30/2009	Information has been received from an office manager concerning a 68 year old female patient with no previous medical history reported, who on 08-DEC-2008 was vaccinated with a dose of PNEUMOVAX (Lot Number 662785/1124X) IM in the left arm.  Concomitant therapy included ACTONEL, iron (unspecified), WELLBUTRIN, NEXIUM, LEXAPRO, BONIVA and meclizine.  On approximately 08-DEC-2008, after received the dose of PNEUMOVAX, the patient developed injection site reaction.  The patient's left arm became red, swollen and painful.  The patient was given BENADRYL and the symptoms resolved.  The patient sought medical attention at office visit.  Additional information has been requested.				Y					Y	12/08/2008	12/08/2008	0	None	OTH	OTH	WELLBUTRIN;  LEXAPRO;  NEXIUM;  BONIVIA;  Iron (unspecified);  MECLIZINE;  ACTONEL		None		WAES0901USA02503	1						2	Erythema; Induration; Local reaction; Swelling; Erythema; Injection site reaction; Oedema peripheral; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA359CA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1124X~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~1124X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0344241	08/06/2009	VA	6.0	6		M	07/30/2009	Information has been received from an office manager concerning a 6 year old male patient with no known allergies and no pertinent medical history.  Who on 31-OCT-2008 was vaccinated with 0.5 ml of a dose of PNEUMOVAX in the right deltoid (I.M.) (Lot# 662042/0622X).  There was no concomitant medication.  On 31-OCT-2008 the patient developed hard, swollen, and tender to touch area at the injection site of the right deltoid.  Subsequently, the patient was seen in the office on 03-NOV-2008 and was prescribed AUGMENTIN.  The patient had recovered.  This is one of several reports from the same source.  Additional information has been requested.				Y					Y	10/31/2008	10/31/2008	0	None	OTH	OTH			None		WAES0811USA02943	1						2	Injection site cellulitis; Injection site induration; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U2797DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB319AA~2~IM~LA~HEP A (HAVRIX)~1|PPV~MERCK & CO. INC.~0622X~1~IM~RA~PNEUMO (PNEUMOVAX)~1|PPV~MERCK & CO. INC.~0622X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0353249	08/06/2009	PA	64.0	64		F	07/23/2009	PPV shot given at top of  left shoulder causing electric shock type jolt down left arm while needle was being forced in by nurse. Symptoms progressed from soreness to paralyzing pain to nausea. Dizziness, uncontrollable shaking, fever, chills, immobility. Unable to leave bed from 8:30pm. until 11:00 am. The following morning when I could get out of bed to call for help. A friend had to drive me to doctor. I had severe headache continued dizziness and instability. Dr diagnosed hematoma from vaccine entering blood stream to quickly. Doctor's RX was 600 mg 4 x day IBUPROFEN for 30 days.  8/17/09 PCP medical records received DOS 10/24/07 to 10/30/07. Assessment: Pneumovax vaccine reaction. Patient presents with tingling in arm and nausea. At time of injection felt pain across left upper deltoid down into arm. Followed by chills, nausea, pain. Could not move arm. Very sore and tender. Pain with movement of shoulder. Feels something is cracking or snapping when she rotates shoulder.			Y	Y				Y	U	10/24/2007	10/24/2007	0	X-ray; MRI showed questionable result; Physical therapy couldn't restore to normal; Bone scan.	PVT	OTH		None	Penicillin Allergy. 8/17/09 PCP medical records received DOS 10/24/07 to 10/30/07. Tonsillectomy, ectopic heartbeats, hysterectomy, hernia, benign breast biopsy, osteopenia.			1						1	Bedridden; Bone scan; Chills; Dizziness; Gait disturbance; Haematoma; Headache; Immobile; Impaired driving ability; Nausea; Nuclear magnetic resonance imaging abnormal; Pain; Paraesthesia; Pyrexia; Tremor; Vaccination error; X-ray	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~79241~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1173F~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening,Disabling	Influenza
0353315	08/06/2009	TX	12.0	12		F	08/06/2009	On 11/16/08, pt went about her day as normal, but became very tired quite suddenly around 5:00 in the evening.  She went to bed to rest (something she rarely did until this point).  After a couple of hours we attempted to wake her to attend church, a favorite activity, and she wanted to continue sleeping.  We let her sleep until the next morning. We made her get up and prepare for school, but before she left, she complained of tiredness, headache, and sore throat, and we allowed her to stay home from school.  She remained in bed for ten days, only getting up to go to the bathroom, shower, or go to the doctor.  We encouraged her to sit up in a chair or even lie down in another room to help increase her energy level, but she did not have the strength for more than a few minutes.   During this time the headache and sore throat remained, along with upper abdominal pain (left side right under ribs).  The symptoms gradually improved, and pt was much better by the end of the first week of December.  From then until the middle of January, pt continued to report mild symptoms, including fatigue and abdominal pain, but she was able to go about her normal activities.  In mid January, pt came home from school, went to bed, and would not get up until morning.  She went to school the remainder of that week with moderate symptoms, only because she was taking mid-term exams.  Since then, pt has had three more occurrences of symptoms, missing one and two days of school.  During these periods she has complained that light hurts her eyes.  Upper abdominal pain, headaches, and sore throat recur periodically.  Pt has also complained of periods of feeling out-of-it, or not being able to concentrate at different times since mid-December.  She has also stated that her legs fall asleep often.  To the best of my knowledge, she has never had fever during this time.  In July she received five injections (HPV/Meningitis/DPT/Varicella/HepA), and two in October (HPV/Influenza).  Lot number for July 2008 HPV vaccine was 1757U.  Lot number for Meningitis vaccine was U2636AA.  8/17/08 PCP Medical records received DOS 7/15/08 to 12/01/08. Assessment: Viral Syndrome. Patient presents with fatigue, sore throat, abdominal pain, headache, achiness, mild nausea.   8/18/08 PCP Medical records received DOS 12/03/08 to 6/11/09 Assessment: Abdominal pain, fatigue. Patient presents with continued fatigue, nausea, and left-side upper abdominal pain. Tenderness to palpation left upper quadrant abdomen. Diarrhea. Knee pain, headaches. Ankle abrasions. Infections disease consult. Gastroenterology consult.				Y					U	10/13/2008	11/16/2008	34	Lab tests performed, all with normal results:  Monospot, EBV titers, CBC, urinalysis, pancreatic enzymes.  Many other blood tests with normal results. Biopsy performed during endoscopy in June 09 showed mild chronic gastritis. Two abdominal ultrasounds and one pelvic ultrasound were performed with normal results.  LABS and DIAGNOSTCS: Monospot (-). Multiple bacteriological, parasite, and viral lab tests negative. Upper Endoscopy with Biopsies - Mild chronic gastritis. CBC - Lymph 41% (H). Urinalysis - Hazy, Blood 2+, RBC 3-9, Mucous many, Sq Epi rare, Bacteria few, Hyal Cast occ. CHEM - Bilirubin Total 1.5 mg/dL (H). Abdominal Ultrasound - WNL. Chest X-ray - WNL.	UNK	UNK		None	None			1						1	Abdominal pain upper; Activities of daily living impaired; Asthenia; Disturbance in attention; Endoscopy abnormal; Epstein-Barr virus test negative; Fatigue; Feeling abnormal; Gastritis; Headache; Mononucleosis heterophile test negative; Oropharyngeal pain; Pancreatic enzymes normal; Photophobia; Ultrasound abdomen normal; Ultrasound pelvis normal; Urine analysis normal	FLU3~SANOFI PASTEUR~U2767AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0570X~2~IM~LL~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0353317	08/06/2009	CA	17.0	17		M	08/06/2009	18 yo recruit on day 24 of his training was brought in for syncope. Was told he passed. States he has been having F/C, night sweats, coughing up blood-quarter size amount of blood at night, and loose bowel movements for past 3 weeks. He has been having decrease in appetite and a 26lb weight loss since starting training. Denies of any CP or SOB. However, has been having N/V and dysuria with increase in frequency. Patient had clinical picture consistent with menigoencephalitis. LP performed showed elevated protein and lymphocytes. CSF culture and gram stain were negative. Patient started on and completed full courses of vancomycin, ceftriaxone, doxycycline, fluconazole, acyclovir, tamiflu, steroids and IVIG. All of patients CSF lab tests for possible causes of menigoencephalitis (sent to state encephalitis project) have returned negative; tests include HSV 1 and 2, VZV, enterovirus, adenovirus, influenza, parainfluenza, WNV, EBV, CMV, and coccidiomycosis Ag. CSF pathology negative for malignancy and parasites.  - Patient developed evidence of opacity of left lower lobe on 23July 2009. Felt to be a result of aspiration pneumonia. Patient treated with vancomycin, ceftriaxone, and doxycycline. Most recent CXR shows resolution of opacity.				Y	Y	45	Y	Y	N	06/15/2009	06/28/2009	13	18Jul09- Non contrast head CT- NO EVIDENCE OF ACUTE INTRACRANIAL HEMORRHAGE OR PARENCHYMAL MASS. 18Jul09 Lumbar Punture: 79 WBC, 9 RBC, Glucose 60, lymphocyte predominance.  few PMNs, no organisms seen, culture negative. 20Jul09- MRI of brain- NEGATIVE MRI EXAMINATION OF THE BRAIN, WITHOUT EVIDENCE OF ABNORMAL ENHANCEMENT, SPECIFICALLY OF THE MENINGES OR TEMPORAL HORNS. 20Jul09 EEG: Diffuse slowing which is nonspecific for cerebral dysfunction. 22Jul09 Testicular Ultrasound: ESSENTIALLY NORMAL TESTICULAR ULTRASOUND WITHOUT EVIDENCE OF A PRIMARY MALIGNANCY. 22Jul09: Bronchoscopy: Mucus plugs in left lung. Culture and gram stain negative.  04Aug09: Bronchoscopy for mucus plug removal. 27Jul09: MRI of T spine: IMPRESSION:  EVIDENCE OF SUBARACHNOID HEMORRHAGIC BLOOD PRODUCTS WITHIN THE THECAL SAC AT THE LEVEL OF THE LUMBAR SPINE WITHOUT DISCRETE IDENTIFICATIONOF A SOURCE. 29Jul09: CT of chest/abdomen/pelvis-  1.LEFT LOWER LOBE COLLAPSE AND RIGHT LOWER LOBE CONSOLIDATION WITH RIGHT PARAPNEUMONIC PLEURAL EFFUSION. 2. A SMALL AMOUNT OF NONCOMPLEX FREE FLUID WITHIN THE PELVIS. 3. NO EVIDENCE OF BOWEL OR URETERAL OBSTRUCTION. 4. TRACHEOSTOMY, ENTERIC TUBE, AND RIGHT UPPER EXTREMITY PERIPHERALLY INSERTED CENTRAL CATHETER IN PLACE. 29Jul2009: Tracheostomy placed. 03Aug09:MRI T spine T2FSE protocol: PREVIOUSLY DESCRIBED INCREASED T2 SIGNAL WITHIN THE SPINAL CORD IS LESS CONSPICUOUS ON TODAY'S EXAMINATION WITHOUT EVIDENCE OF ABNORMAL ENHANCEMENT AND THIS FINDING LIKELY IS ARTIFACTUAL.	UNK	UNK		Fever, chills, night sweats, coughing up blood-quarter size amount of blood at night, and loose bowel movements for 3 weeks. He has been having decrease in appetite and a 26lb weight loss since starting training. Denies of any CP or SOB. However, has been having N/V and dysuria with increase in frequency.	None.			1						1	Blood product transfusion; Bronchoscopy abnormal; CSF culture negative; CSF glucose normal; CSF lymphocyte count increased; CSF protein increased; CSF white blood cell count increased; Chills; Computerised tomogram abnormal; Computerised tomogram normal; Culture negative; Decreased appetite; Diarrhoea; Dysuria; Electroencephalogram abnormal; Encephalitis; Gram stain negative; Haemoptysis; Lymphocyte count decreased; Nausea; Night sweats; Nuclear magnetic resonance imaging abnormal; Nuclear magnetic resonance imaging brain normal; Pneumonia aspiration; Pollakiuria; Pyrexia; Red blood cell count decreased; Red blood cells CSF positive; Syncope; Testicular scan normal; Vomiting; Weight decreased; White blood cell count increased	FLUN3~MEDIMMUNE VACCINES, INC.~U2791DA~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB162AA~1~IM~UN~HEP A + HEP B (TWINRIX)~1|MNQ~SANOFI PASTEUR~U2643AA~1~IM~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|PPV~MERCK & CO. INC.~0343Y~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation,Disabling	Influenza
0353344	08/06/2009	PA	66.0	66		F	07/30/2009	Information has been received from a nurse concerning a 66 year old female with no pertinent medical history and no known drug allergies who on 13-OCT-2008 was vaccinated with the first dose of PNEUMOVAX 23 (Lot#659199/1541U) IM right arm. After administration the patient experienced severe muscle pain in her right arm, She would not let any touch her arm. She developed erythema of right arm with central induration at the injection site. The skin was warm to touch. The nurse considered these events to be disabling because the patient is not able to drive. On the same day the patient also received influenza virus vaccine (manufacturer unspecified), but in the left arm. The patient sought medical attention and at the time of report on 16-OCT-2008, patient was not recovered. This is one of several reports received from the same source. Additional information has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.				Y				Y	N	10/13/2008	10/13/2008	0	None	OTH	OTH			None		WAES0810USA03209	1						1	Impaired driving ability; Injection site erythema; Injection site induration; Injection site pain; Injection site warmth; Myalgia	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1541U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0353345	08/06/2009	FL	97.0			F	07/30/2009	Information has been received from a physician concerning a 97 year old female patient with no pertinent medical history who was vaccinated with a 0.5 ml IM dose of PNEUMOVAX greater than 5 years ago (lot # 658555/0964U).  Concomitant therapy included influenza virus vaccine (unspecified).  About 24 hours after receiving PNEUMOVAX the patient experienced cellulitis of the arm at the injection site characterized by a very swollen, red and tender arm.  No lab diagnostics studies were performed.  At time of reporting, the adverse event is ongoing.  The patient sought medical attention via office visit.  Cellulitis of the arm at the injection site was considered to be disabling.  This is one of the several reports from the same source.  Additional information has been requested.				Y				Y	N				None	OTH	OTH			None		WAES0810USA03324	1						1	Injection site cellulitis; Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0964U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0353348	08/06/2009	AR				M	07/30/2009	Information has been received from a physician concerning a male who was vaccinated with a first dose of PNEUMOVAX 0.5 mL.  Concomitant vaccination included a dose of influenza virus vaccine (unspecified) at the same visit.  The patient experienced an anaphylactic reaction after receiving PNEUMOVAX and the dose of influenza virus vaccine (unspecified).  The patient was seen at the emergency room and was treated with EPINEPHRINE.  At time of reporting, the patient had recovered.  The physician considered the anaphylactic reaction to be life threatening and other important medical event.  Additional information is not expected.			Y	Y					Y				Unknown	OTH	OTH			Unknown		WAES0810USA04978	1						1	Anaphylactic reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening	Influenza
0353353	08/06/2009	NE	79.0	79		F	07/30/2009	Information has been received from a pharmacist concerning a 79 year old female who on 03-NOV-2008 was vaccinated with PNEUMOVAX, Lot number 662687/0983X. Concomitant therapy included flu vaccine (manufacturer not reported) in the same arm. It was reported that the patient on 04-NOV-2008 had a red and swollen arm at the injection site where the PNEUMOVAX was given. The patient was hospitalized and given IV steroids. At the time of the report the patient was recovering. The patient sought medical attention, contacted physician. This is one of several reports concerning the same source. Additional information has been requested.				Y	Y				N	11/03/2008	11/04/2008	1	Unknown	OTH	OTH			Unknown		WAES0811USA00896	1						1	Injection site erythema; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~Arm~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0983X~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0353357	08/06/2009	OR	49.0	49		F	07/30/2009	Information has been received from a registered nurse concerning a 49 year old female patient with cancer and no drug reactions or allergies who on 03-NOV-2008 was vaccinated with a 0.5ml dose of PNEUMOVAX (lot # 661529/0868X). On 03-NOV-2008 the patient experienced cellulitis in the arm of administration. No lab diagnostics studies were performed. The patient was recovering from the cellulitis in the arm of administration. The patient sought medical attention via seen at the practice. Follow up information has been received concerning a 49 year old female patient with cancer, asthma, thrombocytopenia and macrocytosis who on 03-NOV-2008 was vaccinated with a 0.5ml dose of PNEUMOVAX (lot # 661529/0868X). Concomitant medication included influenza virus vaccine (unspecified) and darbepoetin. The illness at time of vaccination was multifactorial anemia thought to be related to her ulcerative colitis. On 03-NOV-2008 the patient developed the right upper biceps tenderness, erythema and swelling. She reported on right hand numbness nor tingling, but the tenderness was on the medial and axillary portion of her right upper arm. The patient denied shortness of breath, chest pain. She had no fevers, chills, night sweats, cough, cold, congestion or shortness of breath. Physical examination was performed, and the result showed that there was multilevel sites of mechanical purpura, the upper extremity had evidence of erythema running circumferential around the right biceps, and there was tenderness appreciated in the medical aspect deep portion of the right axilla in addition to the lateral aspect of the shoulder. The physician assessed that recent PNEUMOVAX and flu injection resulted in right upper extremity tenderness and swelling, and he could not rule out deep vein thrombosis (DVT) based on the patient's physical exam. A Doppler will be ordered in addition will start AUGMENTIN. The physician also recommended the patient took BENADRYL, but the patient stated that caused profound anxiety. He would have the patient start antihistamine in the form of ZYRTEC 10 mg daily. On 06-NOV-2008, the patient was seen in triage for redness and soreness in right upper arm. The deltoid muscle was still sore. The patient stated that there was some redness in the deltoid on 05-NOV-2008 and there was horizontal reddening across the inner bicep on 06-NOV-2008. The patient had tenderness in bicep, deltoid, and under armpit. DEG was asked to evaluate patient. On 12-NOV-2008, the patient stated that she was doing very well. There was no swelling or soreness in her right arm or bicep. The redness was gone also. The patient had one more day of antibiotic to finish. On 14-NOV-2008, the patient came to triage following a lab draw. Labs reviewed with HGB 11.1, HCT 33.3. Blood pressure slightly elevated at 144/91 and patient stated that she had been up since 4:30 in the morning. Patient's right arm had no more redness or swelling. The patient stated that it was feeling much better. Cellulitis in the arm of administration was considered to be disabling and an other important medical event. This is one of several reports from the same source. Additional information is not expected.				Y				Y	Y	11/03/2008	11/03/2008	0	physical examination, mechanical purpura, upper extremity: erythema around the right biceps; tenderness; blood pressure, 144/9; hemoglobin, 11.1; hematocrit, 33.3	PVT	PVT	darbepoetin alfa	Anemia; Cancer; Asthma; Thrombocytopenia; Macrocytosis; Colitis ulcerative			WAES0811USA01642	1						1	Cellulitis; Haematocrit decreased; Haemoglobin decreased; Injection site cellulitis; Injection site erythema; Injection site pain; Injection site swelling; Purpura	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0868X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0353358	08/06/2009	NJ	18.0	18		F	07/30/2009	Information has been received from an office manager concerning a female who on 26-NOV-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot #656439/0577U). On an unspecified date the patient developed cellulitis and was hospitalized. At the time of this report, it was unknown if the patient was still hospitalized or her present status. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and was released. Follow-up information was received from the office manager via medical records which reported that on 26-NOV-2008 the 18 year old female patient was vaccinated with a dose of PNEUMOVAX 23 (lot #656439/0577U) in the left arm. On the same day, the patient also received a dose of FLUZONE (lot # U2853AB) in the left arm. Thereafter, on approximately 28-NOV-2008, the patient developed fever, headache, left arm pain and was seen in the doctor's office where they noted her to have an elevated white count of 33000. On 28-NOV-2008, the patient was sent to the hospital for further evaluation. Upon admission, the child was afebrile. The left upper arm was red, indurated and tender all around the entire injection site. The rest of the physical exam was normal. Upon admission the white count in the hospital was 25.4. During the hospital stay, there was a repeat white count the day after admission where the white count had gone down to 17000. The child continued on TORADOL and MOTRIN for pain. There was an infectious disease consult which another physician thought that it might have either been a local reaction to the vaccination of PNEUMOVAX 23 versus a cellulitis of the area. During the hospital course the child was treated with UNASYN IV. She defervesced and her redness and swelling of her arm gradually improved. She was discharged home on 02-DEC-2008 to continue P.O. AUGMENTIN XR, 1 tablet, twice a day for 1 week. It was reported that the patient had fully recovered. This is one of several reports received from the same source. Additional information is not expected.				Y	Y	3			Y	11/26/2008	11/28/2008	2	WBC count, 11/28?/08, 33000; WBC count, 11/28/08, 25.4; WBC count, 11/29/08, 17000	PVT	PVT			Unknown		WAES0812USA00522	1						1	Cellulitis; Headache; Injection site erythema; Injection site induration; Injection site pain; Oedema peripheral; Pain in extremity; Pyrexia; White blood cell count increased	FLU3~SANOFI PASTEUR~U2853AB~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0577U~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0353362	08/06/2009		46.0	46		M	07/30/2009	Information has been received from a registered pharmacist concerning a 46 year old male with penicillin allergy. On 07-MAR-2009 the patient was hospitalized for an unknown reason. While hospitalized on 08-MAR-2009 the patient was vaccinated with a dose of PNEUMOVAX 23 and a dose of FLUZONE and discharged. On 10-MAR-2009 the patient was readmitted to the hospital for cellulitis reaction to PNEUMOVAX 23. The patient experienced fever of 103F. He had redness and pain at the PNEUMOVAX 23 injection site. The patient was treated with vancomycin. The lot number of the PNEUMOVAX 23 could not be identified and no lot check required. White blood cell count (WBC) was performed with result 20.1x1000. At the time of this report, the patient was recovered. Follow-up information was received from the registered pharmacist. The pharmacist refused to give the patient's name. The patient was admitted to the hospital on 07-MAR-2009 for back surgery (type not reported). The patient was discharged from the hospital on 09-MAR-2009. The patient was diagnosed with cellulitis and readmitted to the hospital on 10-MAR-2009. The patient was discharged from the hospital on 13-MAR-2009. The pharmacist stated that she did not have the PNEUMOVAX 23 lot number. This is one of several reports from the same source. No further information is available.				Y	Y	4			Y	03/08/2009	03/08/2009	0	WBC count, 03/10?/09, 20.1; body temp, 03/08?/09, 103F	OTH	OTH		Penicillin allergy; Hospitalisation	Surgery; Back disorder		WAES0903USA03638	1						1	Body temperature increased; Cellulitis; Injection site erythema; Injection site pain; Pyrexia; White blood cell count increased	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0353531	08/06/2009	FL				F	07/30/2009	Information has been received from a female consumer (age unknown) who on an unspecified date was vaccinated (route unknown) with a dose of PNEUMOVAX (manufacturer unknown, lot # unknown) and a dose of influenza virus vaccine (unspecified, manufacturer unknown).  Subsequently, after receiving the vaccinations, on an unknown date, the patient experienced injection site reactions.  It is unknown if the patient sought medical attention.  No product quality complaint was involved.  Additional information has been requested.									U				Unknown	OTH	OTH			Unknown		WAES0807USA04128	1						1	Injection site reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353569	08/06/2009	MI	60.0	60		F	07/30/2009	Information has been received from an office manager concerning a 60 year old female with hyperlipidaemia, hypothyroidism and drug hypersensitivity to IODINE, CODEINE, COMPAZINE, DEMEROL and anesthetics;  a history of gastrooesophageal reflux disease (GERD), kidney stones and atrial fibrillation in 2003 who on 26-AUG-2008 was vaccinated intramuscularly into the right arm with a dose of PNEUMOVAX (Lot # 660717/0224X).  Concomitant therapy included influenza virus (unspecified) into the left arm, SYNTHROID, SIMVASTATIN (MSD), estrogens, conjugated PREMARIN and ASPIRIN.  On approximately 26-AUG-2008 the patient experienced the injection site to be hard as a rock and the size of a golf ball.  The right arm throbbed and the injection site area was red and the size of a 50 cent piece.  It was unknown if the patient received the vaccine in the past.  The past sought unspecified medical attention.  The patient was given BENADRYL.  No diagnostic laboratory studies were performed.  At the time of this report, the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.									U	08/26/2008	08/26/2008	0	Unknown	OTH	OTH	ASPIRIN;  PREMARIN;  SYNTHROID;  ZOCOR	Hyperlipidaemia;  Hypothyroidism;  Drug hypersensitivity	Gastrooesophageal reflux disease;  Kidney stone;  Atrial fibrillation		WAES0808USA05487	1						1	Injection site erythema; Injection site induration; Injection site swelling; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0224X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353572	08/06/2009	MI	44.0			F	07/30/2009	Initial and follow-up information has been received from an office manager concerning a 44 year old female with seizure disorder, severe mental retardation, high cholesterol and no drug reactions or allergies or illness at time of vaccination who in 2005 was vaccinated with the first dose of PNEUMOVAX 23 vaccine (It was reported in follow-up that there was no previous dose). On 27-Aug-2008 at 12:00 the patient was vaccinated IM in the left arm with the second 0.5 ml dose of PNEUMOVAX 23 (lot# 660717/0224X). Concomitant therapy included influenza virus vaccine (unspecified). On 27-AUG-2008, the same day, the patient's guardian called the doctor's office to report that the arm at the injection site was hard and swelled up to a size of a baseball. The patient was taken to the emergency room by the guardian. The patient was not hospitalized, and was treated with MEDROL DOSEPAK and or BENADRYL. The patient sought medical attention in the doctor's office. No lab tests were performed. The office manager reported in follow up that after few days, the patient's injection site swelled up to a size of a baseball was recovered. Additional information is not expected.														UNK	UNK		Convulsion disorder; Mental retardation; Cholesterol high			WAES0809USA00032	1						1	Injection site induration; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353660	08/06/2009	MO				F	07/30/2009	Information has been received from a female consumer (age unknown), who, on an unspecified date, was vaccinated with a dose of PNEUMOVAX (manufacturer unknown). Concomitant vaccination included influenza virus vaccine (unspecified). Other concomitant therapy included SYNVISC. Subsequently, on an unspecified date, the patient experienced sweating, difficulty breathing, and developed hives. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Follow up information received from the patient and she reported that she didn't remembered the name because it has been several years since and she didn't know how to contact or if still in business (physician was elderly). Additional information is not expected.									U				Unknown	OTH	OTH	SYNVISC		Unknown		WAES0809USA01415	1						1	Dyspnoea; Hyperhidrosis; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353672	08/06/2009	IL				F	07/30/2009	Information has been received from an approximately 69 year old female who reported that approximately 9 or 10 years ago, she was vaccinated with PNEUMOVAX. (lot # not reported) Concomitant therapy included influenza virus vaccine (unspecified). On the same day of the vaccinations the patient developed an injection site rash. The rash appeared on the same both of the injection sites of PNEUMOVAX and the influenza virus vaccine (unspecified). The patient reported that she was seen by a nurse. On an unreported date the patient recovered from injection site rash. No further information is available. Additional information is not expected.				Y					Y				Unknown	OTH	OTH			Unknown		WAES0809USA01821	1						1	Injection site rash	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0353675	08/06/2009	FL	65.0			M	07/30/2009	Information has been received from a consumer concerning her 65 year old husband with an allergic reaction to sulfa drugs and no pertinent medical history who on 08-SEP-2008 was vaccinated IM with PNEUMOVAX (lot # 659487/1960U) 0.5mL/single dose.  Concomitant therapy included influenza virus vaccine (unspecified).  On 09-SEP-2008 the patient developed a streaking rash that went around both arms and on the skin of his testicles after receiving PNEUMOVAX.  The patient sought unspecified medical attention.  The reporter had no additional information.  At the time of the report the patient had not recovered from streaking rash that went around both arms and on the skin of his testicles.  Additional information has been requested.									N	09/08/2008	09/09/2008	1	None	OTH	OTH		Sulfonamide allergy			WAES0809USA01945	1						1	Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1960U~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353682	08/06/2009					F	07/30/2009	Information has been received from a registered pharmacist concerning a female who on an unknown date was vaccinated with a dose of PNEUMOVAX.  Concomitant therapy included influenza virus vaccine (unspecified).  Subsequently the patient developed and injection site reaction that was described as PNEUMOVAX vaccine site swelling up to the size of a baseball.  All the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  This is one of tree reports from the same source.  Additional information has been requested.									U				Unknown	OTH	OTH			Unknown		WAES0809USA04522	1						1	Injection site reaction; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353684	08/06/2009	NY	65.0	65		F	07/30/2009	Information has been received from a registered nurse concerning a 65 year old female with penicillin, codeine, sulfa, DARVON, DEMEROL, morphine, ezetimibe, simvastatin allergies and a history of thyroidism who on 30-SEP-2008 was vaccinated with PNEUMOVAX vaccine IM (lot # 658496/1225U) 0.5 ml and FLUZONE on the same arm. Other concomitant therapy included, SYNTHROID, aspirin, calcium (unspecified) and vitamins (unspecified). On 04-OCT-2008 the patient developed hives. The itchy welts were on the neck, breast, and stomach. The patient had shortness of breath and felt heaviness of chest while sleeping that week. She was given ZYRTEC and was seen on 06-OCT-2008. On an unspecified date the patient recovered from hives, shortness of breath and felt heaviness of chest. This is one of several reports from the same source. Additional information has been requested.				Y					Y	09/30/2008	10/04/2008	4	None	OTH	OTH	SYNTHROID; aspirin; calcium (unspecified); vitamins (unspecified)	Drug hypersensitivity	Penicillin; codeine; sulfa; DARVON; DEMEROL; morphine; ezetimibe; simvastatin allergies; a history of thyroidism		WAES0810USA01827	1						1	Chest discomfort; Dyspnoea; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1225U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0353686	08/06/2009	NY	66.0	66		F	07/30/2009	Information has been received from a registered nurse concerning a 66 year old female with chronic fatigue syndrome, hyperthyroidism, arthritis, stress and incontinence and coeliac disease who in 1995 was vaccinated with PNEUMOVAX vaccine IM 0.5 ml. In 2003 the patient was vaccinated with PNEUMOVAX vaccine IM 0.5 ml. On 03-OCT-2008 the patient was vaccinated with PNEUMOVAX (lot # 662100/0742X) IM 0.5 ml on the right arm and FLUZONE vaccine on the left arm. Other concomitant therapy included LEVOXYL, aspirin, PREVACID, PLAQUENIL, estrogens, PREMARIN, vitamin E, calcium (unspecified) (+) vitamin D (unspecified) and omega-3 marine triglycerides. On 03-OCT-2008 the patient developed temperature of 103f, chills and body aches. On 04-OCT-2008 the patient experienced red raised bumps at injection site of the right arm. On 06-OCT-2008 the patient recovered from temperature of 103f, chill, body aches and red raised bumps at injection site. The patient sought medical attention and spoke with physician on 06-OCT-2008. This is one of several reports from the same source. Additional information has been requested.									Y	10/03/2008	10/03/2008	0	Body temp, 103f	OTH	OTH	Aspirin, calcium (unspecified); PREMARIN; PLAQUENIL; PREVACID; LEVOXYL; Omega-3 marine triglycerides; vitamin E	Chronic fatigue syndrome; Hyperthyroidism; Arthritis; Stress; Incontinence; Coeliac disease; Gluten intolerance; Drug hypersensitivity			WAES0810USA01845	1						1	Body temperature increased; Chills; Injection site erythema; Injection site rash; Pain	FLU3~SANOFI PASTEUR~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0742X~3~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353687	08/06/2009	NY	60.0	60		M	07/30/2009	Information has been received from a nurse concerning a 60 year old male with gout, thalamic syndrome, gastroesophageal reflux disease, benign prostatic hyperplasia, ppd skin test positive and a history of bladder cancer who on 08-OCT-1998 was vaccinated IM with his first dose of PNEUMOVAX vaccine (lot number not reported). On 03-OCT-2008, he was vaccinated IM with the second dose of PNEUMOVAX vaccine (lot number 662100/0742X) into the left arm. Concomitant therapy included FLUZONE which was vaccinated IM into the right arm on the same day, metoprolol, allopurinol, omeprazole, LIPITOR, amlodipine, ascorbic acid/vitamin B complex, vitamins (unspecified), aspirin, testosterone and VIAGRA. On 06-OCT-2008 the patient experienced redness and swelling of the whole arm from the shoulder to the wrist. patient was seen on 07-OCT-2008 and his symptoms receded drastically. He was diagnosed with cellulitis and was treated with KEFLEX. This one of several reports received from the same source. Additional information has been requested.				Y					N	10/03/2008	10/06/2008	3	PPD Skin test, positive	OTH	OTH	Metoprolol; Allopurinol; Omeprazole; LIPITOR; Amlodipine; Ascorbic acid/vitamin B complex; Vitamins (unspecified); Aspirin; Testosterone; VIAGRA	Gout; Thalamic syndrome; Gastroesophageal reflux disease; Benign prostatic hyperplasia;  PPD skin test positive	Bladder cancer		WAES0810USA01854	1						1	Cellulitis; Erythema; Oedema peripheral; Tuberculin test positive	FLU3~SANOFI PASTEUR~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0742X~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0353695	08/06/2009	OR	66.0			F	07/30/2009	Information has been received from a physician an approximately 66 year old female who on an unspecified date was vaccinated at the health department with PNEUMOVAX 23 (lot # not reported). On the same date, the patient was also vaccinated with influenza virus vaccine (unspecified). Subsequently, on an unspecified date the patient experienced tender, large, erythematous, raised area below the injection site. The physician reported that the are is getting worse and that the patient is not allowing her to even touch the are as it is so painful. The patient also experienced flu-like symptoms. The patient sought unspecified medical attention. No further information was available.									N				Unknown	PUB	OTH			Unknown		WAES0810USA02006	1						1	Influenza like illness; Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353696	08/06/2009	TX	49.0	49		F	07/30/2009	Information has been received from a certified medical assistant concerning a 49 year old female with PENICILLIN and SULFONAMIDE allergies and a history of splenectomy who on an unspecified date was vaccinated with a first dose of PNEUMOVAX.  (Lot # not reported).  On 08-OCT-2008, the patient was vaccinated IM into the right arm with a second dose of 0.5 mL of PNEUMOVAX.  (lot #659778/0024X given is for MMR).  Concomitant therapy included influenza virus vaccine (unspecified) into the left arm, and hormonal contraceptives (unspecified).  The medical assistant reported that on 10-OCT-2008 the patient was seen in the office and was diagnosed with cellulitis of her right arm at the injection site.  At the time of the report, the cellulitis of her right arm at the injection site had not resolved.  Additional information has been requested.				Y					N	10/08/2008	10/10/2008	2	None	OTH	OTH	Hormonal contraceptives	PENICILLIN allergy;  SULFONAMIDE allergy	Splenectomy		WAES0810USA02028	1						1	Injection site cellulitis	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0353699	08/06/2009					U	07/30/2009	Information has been received from a registered pharmacist concerning a patient who on an unknown date was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient developed an injection site reaction that was described as the PNEUMOVAX 23 vaccine site swelling up to the size of a baseball. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. This is one of three reports from the same source. Additional information has been requested.									U				Unknown	OTH	OTH			Unknown		WAES0809USA04790	1						1	Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353701	08/06/2009					U	07/30/2009	Information has been received from a registered pharmacist concerning a patient who on an unknown date was vaccinated with a dose of PNEUMOVAX (unspecified). Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient developed an injection site reaction that was described as the PNEUMOVAX site swelling up to the size of a baseball. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. This is one of three reports from the same source. Additional information has been requested.									U				Unknown	OTH	OTH			Unknown		WAES0809USA04791	1						1	Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353702	08/06/2009	CO	60.0			M	07/30/2009	Information has been received from a physician concerning himself, a 60 year old male with no pertinent medical history and no drug reactions or allergies who on 26-SEP-2008 was vaccinated intramuscularly with PNEUMOVAX 23 (lot # not reported). Concomitant therapy included influenza virus vaccine (unspecified) which was administered in the same arm at the same office visit. On 26-SEP-2008 the patient developed fever, chills, and a sore arm 8-9 hours after receiving the PNEUMOVAX 23 vaccine. The patient's fever (unspecified as low-grade fever) and chills lasted 48 hours. At the time of the report the arm pain was resolving. The physician reported that he took ALEVE and TYLENOL for the symptoms. No other symptoms or treatment reported. No other information was available. Additional information has been requested.									N	09/26/2008	09/26/2008	0	None	OTH	OTH	Unknown		None		WAES0809USA04852	1						1	Chills; Pain in extremity; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~Arm~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353710	08/06/2009	IA	71.0			F	07/30/2009	Information has been received from a Registered Nurse (R.N.) and a Registered Pharmacist (R.Ph) concerning a 71 year old female patient who was vaccinated IM with a dose of PNEUMOVAX 23 vaccine lot # 662100/0742X. Concomitant therapy included FLUZONE. The reporter reported that patient developed a severe headache and severe neck pain after receiving the PNEUMOVAX 23 vaccine. Patient also developed a sore arm. Patient was told to take ibuprofen and TYLENOL. No other details was reported. The outcome was unknown. Additional information has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.									U				Unknown	OTH	OTH			Unknown		WAES0810USA00443	1						1	Headache; Neck pain; Pain in extremity	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0742x~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353711	08/06/2009	IA				F	07/30/2009	Information has been received from a registered pharmacist and a registered nurse concerning an approximately 66 year old female patient with no pertinent medical history and no drug reactions or allergies who on an unspecified date was vaccinated with PNEUMOVAX (lot # 662100/0742X) 0.5 mL IM. Concomitant therapy included FLUZONE which was given the same day but in the opposite arm. On an unspecified date, the patient developed headache and nausea. The injection site was red, warm and swollen to the size of a softball and was raised. 1cm. The patient sought medical attention in the office. On an unspecified date the patient underwent an electrocardiogram (EKG) and glucose and potassium levels were drawn. Results for labs and diagnostics were not reported. The reporters stated that the patient was told to take ibuprofen and TYLENOL. It is unknown if the patient recovered. No other details were available. A lot check was requested by the nurse. This is one of several reports received from the same source. Additional information has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.				Y					U				electrocardiogram, Result not reported; serum potassium, Result not reported; serum glucose, Result not reported	UNK	UNK			None		WAES0810USA00448	1						1	Blood glucose; Blood potassium; Electrocardiogram; Headache; Injection site erythema; Injection site swelling; Injection site warmth; Nausea	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0742X~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0353714	08/06/2009	IA	65.0			F	07/30/2009	Information has been received from a pharmacist and a nurse concerning a 65 year old female patient with allergic reaction to penicillin, erythromycin and sulfonamide and a history of previous vaccination with PNEUMOVAX (date not specified) who was vaccinated IM with a dose of PNEUMOVAX lot # 662100/0742X. Concomitant therapy included FLUZONE. The reporter reported that the patient developed soreness. warmth and swelling at the injection site. She also developed nausea and body aches on 02-OCT-2008. She was given KENALOG 60 mg IM on 02-OCT-2008 because she was presented with swelling and pain from her elbow to her shoulder. No other details reported at this time. The patient had not recovered. A standard lot check was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center and was released. Additional information has been requested.									N		10/01/2008		Unknown	OTH	OTH		Penicillin allergy; Allergic reaction to antibiotics; Sulfonamide allergy	Immunisation		WAES0810USA00486	1						1	Injection site pain; Injection site swelling; Injection site warmth; Nausea; Pain	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0742X~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353719	08/06/2009					M	07/30/2009	Information has been received from a physician concerning a male who was vaccinated with PNEUMOVAX and a day later he experienced body aches and soreness. Concomitant therapy included influenza virus vaccine *unspecified). The patient's outcome was not reported. The patient sought unspecified medical attention. Additional information has been requested.									U				Unknown	OTH	OTH			Unknown		WAES0810USA02479	1						1	Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353722	08/06/2009	PA	65.0	65		M	07/30/2009	Information has been received from a physician concerning a 65 year old male with no drug allergies who on 06-Oct-2008, was vaccinated with PNEUMOVAX (lot # not provided), injection. Concomitant therapy included influenza virus vaccine. Two days after receiving vaccine, on 08-OCT-2008, the patient experienced fever of 103 degrees. A dip urinalysis was positive for nitrites and protein, negative for leukocytes and blood. The patient also had a blood test, which indicated that he had an elevated white count of 23000. In follow-up it was reported the patient was prescribed CIPRO 500 mg BID. Blood work revealed a white blood cell count (WBC) of 26, 2000 with shift. Urine culture was negative and blood cultures x2 were negative. Another white blood count test result was 26200 with shift. The patient also had a urine culture tests which all indicated negative. The patient was treated with CYRO 500 mg bid. On 10-OCT-2008, the patient's fever resolved and the patient fully recovered. Additional information is not expected.									Y	10/06/2008	10/08/2008	2	diagnostic urinalysis, 10,08/08, positive for nitrites and protein; negative for leukocytes and blood; WBC count, 10/08/08, 23000; WBC count, 26200, with shift; urine culture, negative; blood culture, negative	OTH	OTH			Unknown		WAES0810USA02784	1						1	Blood culture negative; Culture urine negative; Pyrexia; Urine analysis abnormal; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353730	08/06/2009	NC	82.0	82		F	07/30/2009	Information has been received from a nurse concerning an 82 year old retired female with high blood pressure, thyroid issues and possible hydrochlorothiazide allergy who on 03-OCT-2008 at 12:00 was vaccinated with PNEUMOVAX 23 (lot # 660717/0224X), 0.5ML, IM in the right deltoid. Concomitant vaccination included FLULAVAL (lot# AFLLA188AA-ID) in the left deltoid. Additional concomitant therapy included LOTREL, SYNTHROID, ZYRTEC, ARTHROTEC, TOPROL XL TABLETS, doxepin HCl, aspirin, omeprazole (MSD), albuterol and MAXIDE. Subsequently, the patient experienced severe pain and muscle aches on the right arm at 18:00 on 03-OCT-2008. The patient was not able to life her arm because of the pain. The patient called the hospital and was instructed to take TYLENOL. The patient called the office on 08-OCT-2008 and she was feeling much better. No lab diagnostics study was performed. Follow up information has been received from a registered nurse concerning an 82 year old retired female with high blood pressure, thyroid issues, possible hydrochlorothiazide allergy and pseudocholinesterase deficiency who on 03-OCT-2008 at 12:00 was vaccinated with the first dose of PNEUMOVAX 23 vaccine (lot # 660717/0224X), 0.5ML, IM in the right deltoid. Concomitant vaccination included FLULAVAL (lot# AFLLA188AA-ID) IM in the left deltoid on 03-OCT-2008 at 11:55. Additional concomitant therapy (LOTREL, SYNTHROID, ZYRTEC, ATHROTEC, TOPROL XL TABLETS, doxepine HCl, aspirin, omeprazole (MSD), albuterol and MAXIDE. Subsequently, the patient experienced terrible pain in the right arm on 03-OCT-2008 at 18:00, muscle ache on 03-OCT-2008 and unable to move arm due to pain and muscle ache. The terrible pain, muscle ache in the right arm and unable to move arm lasted several days and was treated with TYLENOL. The patient was better on 08-OCT-2008. No lab diagnostics study was performed. No further information is available.									Y	10/03/2008	10/03/2008	0	None	PVT	PVT	albuterol; LOTREL; aspirin; ZYRTEC; ARTHROTEC; doxepin hydrochloride; MAXIDE; Synthroid; TOPROL XL TABLETS; PRILOSEC OTC	Blood pressure high; Thyroid disorder; Drug hypersensitivity; Pseudocholinesterase deficiency			WAES0810USA01683	1						1	Injected limb mobility decreased; Injection site pain; Myalgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA188AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0224X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353823	08/06/2009	NC	66.0	66		F	07/30/2009	Information has been received from a registered nurse concerning a 66 year old female who on 08-OCT-2008 was vaccinated with PNEUMOVAX vaccine (lot # 660685/0619X) (dose and site was not reported). The patient was vaccinated with FLUZONE vaccine (unspecified) on the same day. On 10-OCT-2008 the patient experienced an injection site reaction: a golf ball site area that was red and swollen, fever and was vomiting. The patient sought medical attention on unspecified date. At the time of reporting the patient was recovering. This is one of several reports from the same source. Follow up information was received from a registered nurse. It was reported the patient who was a female with hypertension, gastroesophageal reflux disease and hyperlipidaemia and a history of atrial fibrillation on 08-OCT-2008 at 10:00am was vaccinated intramuscularly into the left deltoid with a first dose of PNEUMOVAX vaccine. Concomitant therapy included a fourth dose of FLUZONE vaccine, lot # U2811AA which was vaccinated intramuscularly into the left deltoid on 08-OCT-2008 at 10:01 am. On 10-OCT-2008 the patient presented to the office with complaints of left arm redness and pain in upper deltoid region, area 2 wide x 3 length. The patient was advised TYLENOL, ice packs for comfort measures. On unknown date, the patient recovered. No further information is available				Y					Y	10/08/2008	10/10/2008	2	Unknown	PVT	PVT		Hypertension; Gastroesophageal reflux disease; Hyperlipidaemia	Atrial fibrillation		WAES0810USA03172	1						1	Injection site erythema; Injection site reaction; Injection site swelling; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U2811AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0619X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0353824	08/06/2009	CA	60.0			M	07/30/2009	Information has been received from a pharmacist concerning a 60 year old male with penicillin allergy and allergic reaction to antibiotics who on 13-OCT-2008 was vaccinated with PNEUMOVAX 23 vaccine. Concomitant therapy included influenza virus vaccine (unspecified) in the opposite arm. On 13-OCT-2008 the patient experiences swelling, pain and redness at the injection site. The patient reported to the pharmacist that the area affected looked like 2 welts, one on each side of the injection site. This is the second patient of 2 patients who developed swelling, pain and redness at the injection site after receiving PNEUMOVAX 23 vaccine. The patient had made phone call for medical attention. The pharmacist was requesting a lot check on lot # 0619X. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.				Y					N	10/13/2008	10/13/2008	0	Unknown	OTH	OTH		Penicillin allergy; Allergic reaction to antibiotics			WAES0810USA03232	1						1	Injection site erythema; Injection site pain; Injection site swelling; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~Arm~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0619X~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0353831	08/06/2009	MD	43.0	43		F	07/30/2009	Information has been received from a 43 year old female with allergic reaction to tetracycline who in the fall of 2003 was vaccinated with the first dose of PNEUMOVAX 23 vaccine, IM. On 13-OCT-2008, the patient was revaccinated with PNEUMOVAX 23 vaccine (Lot# 658449/0989U) in her right arm. Concomitant therapy included influenza virus vaccine, in the left arm (name and manufacturer unspecified). On 13-OCT-2008 the patient experienced high fever, pain in lymph nodes, her left side hurt, high injection site heat, extreme pain and heaviness in her arm, malaise, not feeling good and achiness after getting revaccinated in right arm. The patient had symptoms by the afternoon. At the time of the report, the patient was recovering. The patient did not seek medical attention. This is one of several reports received from the same source. No further information is available.									N	10/13/2008	10/13/2008	0	None	OTH	OTH		Allergic reaction to antibiotics			WAES0810USA03401	1						1	Injection site warmth; Lymph node pain; Malaise; Pain; Pain in extremity; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0989U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353847	08/06/2009	NJ	61.0	61		M	07/30/2009	Information has been received from a certified medical assistant and a health care worker concerning a 61 year old male patient who on 08-OCT-2008 was vaccinated with the first dose of PNEUMOVAX 23 (lot # 661528/0867X), in his left arm. Concomitant vaccination included influenza virus vaccine (unspecified) in his right arm. The certified medical assistant reported that the patient's wife stated he experienced redness and warmth on left arm and it was getting better. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.									N	10/08/2008			Unknown	OTH	OTH			Unknown		WAES0810USA04317	1						1	Injection site erythema; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0867X~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353849	08/06/2009	NC				F	07/30/2009	Information has been received from a healthcare worker concerning a female who on 22-OCT-2008, yesterday, was vaccinated with a dose of PNEUMOVAX 23. Suspect therapy included influenza virus vaccine (unspecified) given in the same arm as PNEUMOVAX 23. It was unknown if the patient had received PNEUMOVAX 23 in the past. It was reported that the patient had developed severe swelling, redness and pain of her arm that extended up to her neck. As of 23-OCT-2008, the patient's symptoms persisted. The patient called the office and sought unspecified medical attention. Additional information has been requested.									N	10/22/2008	10/22/2008	0	Unknown	OTH	OTH	Unknown		Unknown		WAES0810USA04324	1						1	Erythema; Pain in extremity; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~Arm~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353850	08/06/2009	NC	64.0			F	07/30/2009	Information has been received from a physician concerning a 64 year old female patient who on 22-OCT-2008 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX (lot number 659199/1541U) (injection site not reported) and a dose of FLUVIRIN at the same injection site. concomitant therapy included CYMBALTA, TIZANIDINE HYDROCHLORIDE and BISOPROLOL FUMARATE/HCTZ. On 22-OCT-2008, later the same day of vaccination, the patient developed swelling, pain and redness at the injection site. The patient called the physician's office. Unspecified medical attention was sought. At time of the report, the patient's symptoms persisted. Follow up was received from the physician who reported the patient had swelling, severe pain and erythema at the injection site with radiation to the neck and down the length of the arm. In 2008, the patient recovered. No further information is expected.									Y	10/22/2008	10/22/2008	0	Unknown	OTH	OTH	BISOPROLOL FUMARATE (+) CYMBALTA; TIZANIDINE HYDROCHLORIDE		None		WAES0810USA04337	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1541U~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353938	08/06/2009	LA	55.0			M	07/30/2009	Information has been received from an office manager concerning a 55 year old male who on 22-OCT-2008, Wednesday of last week, was vaccinated into the arm with the first dose of PNEUMOVAX vaccine. Concomitant therapy on the same day included influenza virus vaccine (unspecified) given in a different arm. Right after getting the vaccine, the patient experienced swelling of the arm from the forearm up that lasted about 3 days. The patient recovered on 25-OCT-2008, Saturday. No lab tests were performed. The patient did not seek medical attention. Additional information has been requested.									Y	10/22/2008	10/22/2008	0	None	OTH	OTH			Unknown		WAES0810USA04918	1						1	Immediate post-injection reaction; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~Arm~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~1~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353945	08/06/2009	IA	50.0	50		F	07/30/2009	Information has been received from a medical assistant concerning a female who on 28-OCT-2008 was vaccinated with PNEUMOVAX 23 (dose and route not reported). On 29-OCT-2008 the patient experienced wheezing and achiness. It was not known if this was the patient's first dose of PNEUMOVAX 23. The patient's wheezing and achiness persisted. Follow-up information has been received from a physician concerning a 50 year old female with anxiety, rhinitis allergic and menopause and a history of irritable bowel syndrome and no illness at the time of vaccination who on 27-OCT-2008 was vaccinated with PNEUMOVAX 23 (lot number: 660717/0224X) IM into her right upper arm. Concomitant therapy included FLUZONE and ADACEL. On 27-OCT-2008 the patient experienced wheezing, bodyaches, headache and sore throat. The patient was treated with naproxen, albuterol, QVAR, and an unspecified medication. Approximate 1 week later, the patient recovered. Additional information is not expected.				Y					Y	10/27/2008	10/27/2008	0	Unknown	PVT	PVT		Anxiety; Menopause; Rhinitis allergic	Irritable bowel syndrome		WAES0810USA05159	1						1	Headache; Oropharyngeal pain; Pain; Wheezing	FLU3~SANOFI PASTEUR~U2789BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0224X~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C3027BA~UNK~IM~UN~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0353948	08/06/2009					U	07/30/2009	Information has been received from a consumer concerning a co-worker who on 13-OCT-2008, the patient was revaccinated with PNEUMOVAX. Concomitant therapy included Influenza virus vaccine (name and manufacturer unspecified). On 13-OCT-2008 the patient experienced high fever, pain in lymph nodes her left side hurt, high injection site heat, extreme pain and heaviness in her arm, malaise, not feeling good, achiness after getting revaccinated and cellulitis. The patient had symptoms by the afternoon. At the time of the report, the patient was feeling better but not recovered. This is one of several reports received from the same source. No additional information is expected.									N	10/13/2008	10/13/2008	0	Unknown	OTH	OTH			Unknown		WAES0810USA05286	1						1	Cellulitis; Injection site warmth; Lymph node pain; Malaise; Pain; Pain in extremity; Pyrexia; Sensation of heaviness	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~2~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353955	08/06/2009	IN	69.0	69		F	07/30/2009	Information has been received from a physician concerning a 69 year old female with drug hypersensitivity to IMURAN (caused by diffuse swelling), lupus and  pulmonary fibrosis who 5 or more years ago was vaccinated with the first dose of PNEUMOVAX. On 27-OCT-2008 at 10:00, the patient received the second dose of PNEUMOVAX (lot #657525/0554U) 0.5 ml IM into the right deltoid and a dose of influenza virus vaccine (SANOFI PASTEUR) (lot#: 62805AA) IM into the left arm. Concomitant  therapy included vitamins (unspecified), calcium (unspecified) and oxygen at night or with exercise of physical activity. On 27-OCT-2008 at 14:00. The patient was starting to get some swelling, soreness and erythema and heat at the injection site in the upper arm on the right side. She had no systemic symptoms of any other swelling. The redness persisted on the second day. On 29-OCT-2008, the patient visited the doctor's office. Physical exam demonstrated: right arm showed some mild erythema and swelling, and warmth involving most of the posterolateral aspect of the right upper arm. The patient was prescribed BENADRYL and cold compresses. On 05-NOV-2008, the patient developed a pain just under the left breast that increased with a cough, a deep breath, but also with any kind of twisting or turning motion. On 06-NOV-2008 the patient visited the physician and complained that since she got PNEUMOVAX vaccine that her lungs had just been a little worse than usual/ She may have some wheezed. The patient felt like she had fevers and chills. She had a chronic cough, with some mild chronic sputum and that was unchanged. Physical exam showed the patient's respirations were even relaxed and no observed cough or sputum production. Her lungs sounded perfectly clear posteriorly without rales or wheezes. No dullness in the bases. Anteriorly there was faint, inspiratory squeak, but otherwise clear. The previous swelling and erythema in the right arm from the reaction to the PNEUMOVAX was totally cleared with complete resolution. The reporter felt that injection site reaction was related to therapy with PNEUMOVAX. Chest X-ray showed the pulmonary fibrotic changes which was no change at all from the X-ray of March, 2008. The physician didn't see infectious process. The patient symptoms suggested she may have some flare of her pulmonary fibrosis. The pain may be a little pleuritis as well. This is one of several reports received from the same source. All three patients developed reactions after receiving PNEUMOVAX (lot# 657525/0554U) from the same multiple dose vial. A standard lot check investigation was performed. All in-process quality checks for the lot number 657525/0554U in question were satisfactory. The lot met the requirements of the Center and was released. Additional information is not expected.				Y					Y	10/27/2008	10/27/2008	0	chest x-ray, 11/07/08, pulmonary fibrotic changes	PVT	PVT	calcium (unspecified); oxygen; vitamins (unspecified)	Drug hypersensitivity; Lupus erythematosus; Pulmonary fibrosis; Cough	Swelling		WAES0811USA00069	1						1	Chest X-ray abnormal; Chills; Condition aggravated; Cough; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pain; Pleurisy; Pulmonary fibrosis; Pyrexia	FLU3~SANOFI PASTEUR~62805AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0554U~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0353965	08/06/2009					F	07/30/2009	Information has been received from a nurse concerning a female who on 30-OCT-2008 was vaccinated with PNEUMOVAX vaccine (lot #662599/1076X), 0.5ml, intramuscularly. Secondary suspect therapy included influenza virus vaccine (manufacturer unspecified) in the same arm on 30-OCT-2008. On 31-OCT-2008, 1 day after the vaccination, the patient experienced redness at the injection site, fever of 103f and chills. It was not known if this was the patient's first dose of PNEUMOVAX vaccine. The nurse was not aware if treatment was prescribed but stated the patient was recovering. The patient sought medical attention with a phone call to the office. This is one of 2 reports received from the same resource. Additional information has been requested.									N	10/30/2008	10/31/2008	1	Unknown	OTH	OTH	Unknown		Unknown		WAES0811USA00236	1						1	Chills; Injection site erythema; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~Arm~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1076X~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353970	08/06/2009					M	07/30/2009	Information has been received from a nurse concerning a male who on 30-OCT-2008 was vaccinated with PNEUMOVAX (Lot #62599/1076X), 0.5ml, intramuscularly.  Secondary suspect therapy included influenza virus vaccine (manufacturer unspecified) in the same arm on 30-OCT-2008.  On 31-OCT-2008, 1 day after the vaccination, the patient experienced redness at the injection site,									N	10/30/2008	10/31/2008	1	Unknown	OTH	OTH	Unknown		Unknown		WAES0811USA00238	1						1	Chills; Injection site erythema; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~Arm~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1076X~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353973	08/06/2009	TX				F	07/30/2009	Information has been received from a physician concerning a female who was vaccinated with PNEUMOVAX (lot # not provided).  Secondary suspect therapy included influenza virus vaccine (unspecified) in the same arm on the same day.  After receiving the vaccination, the patient experienced swelling and redness in the area of the injection.  The patient sought medical attention.  The physician reported that she thought the patient might have cellulitis and did not believe the adverse events were vaccine-related.  At the time of the report, the outcome of the patient was unknown.  Additional information is not expected.									U				Unknown	OTH	OTH	Unknown		Unknown		WAES0811USA00242	1						1	Cellulitis; Injection site erythema; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~Arm~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353977	08/06/2009	VA	76.0			F	07/30/2009	Information has been received from a 76 year old female with a rapid heart beat and allergic reaction to erythromycin and tetracycline who on 04-NOV-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot # was not available). Concomitant therapy included a dose of influenza virus vaccine (unspecified), SYNTHROID and TOPROL XL TABLETS. Two hours later of the post-vaccination, the patient developed swelling on the injection site. The patient sought medical attention. As of 10-NOV-2008, the patient was recovering. No further information is available.				Y					N	11/04/2008	11/04/2008	0	None	OTH	OTH	SYNTHROID; TOPROL XL TABLETS	Allergic reaction to antibiotics; High pulse rate			WAES0811USA01339	1						1	Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0353980	08/06/2009	TX	52.0	52		F	07/30/2009	Information has been received from a healthcare worker concerning a 52 year old female with allergy to soy products, sulfa, BACTRIM, CIPRO and LEVAQUIN and no illness at the time of vaccination who on 31-OCT-2008 was vaccinated with the first dose of PNEUMOVAX 23 (lot#: 660717/0224X) 0.5ml IM into the left deltoid. Concomitant therapy included flu vaccine and albuterol inhaler. After receiving the vaccination the patient experienced itching on her legs and mouth. Subsequently, the patient recovered from itching on her legs and mouth. Follow-up information was received from the healthcare worker. The healthcare worker indicated that the patient called on 03-NOV-2008 and stated she felt itching and wanted to know if the vaccine contained soy. the patient took BENADRYL to treat itching. The patient's itching lasted 1 day and recovered at the time reporting. Additional information is not expected.									Y	10/31/2008	11/01/2008	1	None	PVT	PVT	albuterol	Drug hypersensitivity; Sulfonamide allergy; Allergic reaction to antibiotics; Food allergy			WAES0811USA00510	1						1	Oral pruritus; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0224X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353982	08/06/2009	AZ				F	07/30/2009	Information has been received from an adult female who was vaccinated with PNEUMOVAX 23 (route not reported) in her left arm 1 week after receiving a flu shot in that arm. Since receiving the PNEUMOVAX 23 the patient had been experiencing pain in the injection arm from her armpit to her breast. The patient also had a pulsating sensation in her foot near her ankle in a very distinct pattern. The patient's symptoms persisted. No further information is available.									N				Unknown	OTH	OTH			Unknown		WAES0811USA00542	1						1	Pain in extremity; Sensory disturbance	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353983	08/06/2009		67.0	67		F	07/30/2009	Information has been received from a pharmacist concerning a 67 year old female who on approximately 03-NOV-2008 was vaccinated with PNEUMOVAX 23, 0.5 ml. Concomitant therapy included influenza virus vaccine (unspecified). In November 2008, the patient developed a local swelling and redness at the injection site after receiving a dose of the vaccine. As of 10-NOV-2008, the patient was recovering. The patient was seen by the pharmacist. Additional information has been requested.									N	11/03/2008			None	OTH	OTH			None		WAES0811USA01387	1						1	Injection site erythema; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0353984	08/06/2009	IN	65.0	65		F	07/30/2009	Initial and follow-up information has been received from a physician concerning a 65 year old female with hypertension and joint discomfort who in December 2003 was vaccinated with a first dose of PNEUMOVAX 23 (lot number, injection site and route not reported). On 29-OCT-2008 the patient was vaccinated intramuscularly with a second dose of PNEUMOVAX 23 (lot # 657525/0554U) in the right deltoid and a dose of FLUZONE (lot number U2805AA) in the left deltoid. Concomitant therapy also included TENORMIN, glaucoma drops, hydrochlorothiazide (manufacturer unknown) and LILPITOR. The physician reported that the patient's blood pressure had been checked once or twice a week and remained stable. Three or four weeks ago actually got a bit low into the 90s. Five days ago she started on 50 mg of INDOCIN a day for some joint discomfort and coincident with that her BP jumped up into the 155 range systolic with normal diastolics. On the same day, within about 4-5 hours after receiving the vaccine, the patient experienced pain, swelling and erythema which had gradually involved the upper arm on the right side. She had not other systemic symptoms. On 31-OCT-2008, the patient visited the doctor's office. Physical examination showed that BP: 154/80, pulse 70 and regular. Lungs: clear. From just distal to the shoulder to approximately the elbow of the right arm, there was mild generalized erythema, mild warmth and some mild swelling. The physician stated that this was all consistent with a reaction to the PNEUMOVAX 23. The patient had been using TYLENOL and was prescribed BENADRYL 50 mg every 4 hours as needed, along with moist warm compresses. As of the reporting time, the patient recovered from the events. This is one of several reports received from the same source. All these patients developed reactions after receiving PNEUMOVAX 23 (lot # 657525/0554U) from the same multiple dose vial. A standard lot check investigation was performed. All in-process quality checks for the lot number 657525/0554U in question were satisfactory. The lot met the requirements of the center and was released. Additional information is not expected.				Y					Y	10/29/2008	10/29/2008	0	Unknown	PVT	PVT	[therapy unspecified]; TENORMIN; LIPITOR; hydrochlorothiazide	Hypertension; Discomfort in joints			WAES0811USA00642	1						1	Erythema; Pain; Skin warm; Swelling	FLU3~SANOFI PASTEUR~U2805AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0554U~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0353996	08/06/2009		60.0			M	07/30/2009	Information has been received from a registered pharmacist concerning a 60 to 65 year old male patient, with no known allergies, who on 07-NOV-2008 was vaccinated with a dose of PNEUMOVAX. Concomitant therapy included Influenza virus vaccine (unspecified). On 10-NOV-2008 the patient experienced painful stiff neck, fever and rash under his arm. The pharmacist said the patient's wife described these as meningitis like symptoms. The patient was placed on OXYCONTIN for the pain with his stiff neck and BENADRYL for the rash. The physician did not diagnose meningitis. At the time of this report the patients fever was improved but the stiff neck and rash under his arm persisted. On 11-NOV-2008 the patient was sleepy but able to go to work. The patient sought medical attention through an office visit. Additional information has been requested.				Y					N	11/07/2008	11/10/2008	3	Unknown	OTH	OTH			Unknown		WAES0811USA01713	1						1	Musculoskeletal stiffness; Neck pain; Pyrexia; Rash; Somnolence	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0354010	08/06/2009	OH	53.0			F	07/30/2009	Information has been received from a nurse concerning a 53 year old female with DARVOCET allergy history and no medical history who on 13-NOV-2008 was subcutaneously vaccinated with 0.5 ml dose of PNEUMOVAX (lot number #661065/1021X). Concomitant therapy included influenza virus vaccine (unspecified). On 13-NOV-2008, after receiving PNEUMOVAX, the patient developed red and swelling area approximately two inch in diameter at the injection site. The area was also hard and bruised. The patient was radiated from her arm onto her shoulder. The outcome was recovering. The patient sought medical attention by calling the office. This is one of 3 cases from the same source. Additional information has been requested.									N	11/13/2008	11/13/2008	0	None	OTH	OTH			Drug hypersensitivity		WAES0811USA02349	1						1	Injection site erythema; Injection site haematoma; Injection site induration; Injection site swelling; Musculoskeletal pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1021X~UNK~SC~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0354011	08/06/2009	OH	35.0			F	07/30/2009	Information has been received from a nurse concerning a 35 year old female with allergy to nortriptyline and no pertinent medical history who on 03-NOV-2008 was vaccinated SC with a 0.5 ml dose of PNEUMOVAX (lot # 662662/0979X). Concomitant therapy included influenza virus vaccine (unspecified). On the same day, the patient developed swelling, redness and tenderness at the injection site. The patient was recovering from swelling, redness and tenderness at the injection site. No lab tests were performed. The patient called the office and sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.									N	11/03/2008	11/03/2008	0	None	OTH	OTH		Drug hypersensitivity			WAES0811USA02350	1						1	Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0979X~UNK~SC~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0354012	08/06/2009	OH	62.0			F	07/30/2009	Information has been received from a nurse concerning a 62 year old female with sulfonamide allergy, allergy to tetanus toxoid and no pertinent medical history who on 04-NOV-2008 was vaccinated SC with a 0.5 ml dose of PNEUMOVAX *lot # 661065/1021X). Concomitant therapy included influenza virus vaccine (unspecified). On the same day, the patient developed numbness and redness at the injection site. She had to go to an emergency room because she also had 102 degrees F fever. At the time of this report, the patient was recovering. No lab tests were performed. This is one of several reports received from the same source. Additional information has been requested.				Y					N	11/04/2008			None	OTH	OTH		Sulfonamide allergy; Allergy to vaccine			WAES0811USA02359	1						1	Injection site anaesthesia; Injection site erythema; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1021X~UNK~SC~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0354015	08/06/2009		30.0			F	07/30/2009	Information has been received from a consumer concerning his 30 year old wife with asthma and seasonal allergies who on 14-NOV-2008 was vaccinated with PNEUMOVAX (lot# not provided).  Concomitant therapy included montelukast sodium (MSD), rizatriptan benzoate (MSD), influenza virus vaccine (unspecified) at the same time, PULMICORT.  On 17-NOV-2008 the patient became lethargic and experienced malaise.  The injection site was red, warm to touch, extremely sore, raised, and swollen.  The patient's symptoms persisted.  The patient did not seek medical attention.  Additional information has been requested.									N	11/14/2008	11/17/2008	3	Unknown	OTH	OTH	ALBUTEROL;  PULMICORT;  SINGULAIR;  MAXALT	Asthma;  Seasonal allergy			WAES0811USA02643	1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Lethargy; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0354105	08/06/2009	ID	49.0			F	07/30/2009	Information has been received from a nurse concerning a 49 year old female patient with immunosupression who on 11-NOV-2008 was vaccinated with a dose of PNEUMOVAX (lot # not provided) and was vaccinated on the same day and on the same arm with a dose of (FLUVIRIN). On 11-NOV-2008, six hour post vaccination, the patient experienced nausea, fever, vomiting, soreness of arm and a developed a 4 by 3 cm ecchymosis with no erythema in upper right arm. It was reported that the patient sought medical attention at a different clinic due to the reaction she was experiencing with the vaccination, and was told in the urgent care clinic that the PNEUMOVAX vaccine and the FLUVIRIN should have been given in different arms. Nurse reported that the patient might seek legal action against the physician's office who gave the vaccinations. Additional information has been requested.				Y					U	11/11/2008	11/11/2008	0	Unknown	OTH	OTH		Immunosupression			WAES0811USA03556	1						1	Ecchymosis; Nausea; Pain in extremity; Pyrexia; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0354107	08/06/2009	CT	73.0	73		F	07/30/2009	Information has been received from an office manager concerning a 73 year old female patient with hypertension and hypercholesterolaemia and a history of thyroid nodule and lung nodule who in 19-NOV-2008 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX (LOT# 661577/1161X). First dose was given on 2003. Concomitant therapy included alendronate sodium, ZOLOFT, ALTACE, amlodipine, aspirin and influenza virus vaccine (unspecified). The reporter stated that in the evening of 19-NOV-2008 the patient experienced an injection site reaction on her left deltoid, a redness and cellulitis-like reaction of half of her upper arm. An unspecified antibiotic was prescribed. Her outcome was unknown. Follow-up information has been received from a health professional concerning a 73 year old female retired patient with no known drug allergies who on 19-NOV-2008 was vaccinated intramuscularly in her left deltoid with a 0.5 ml dose of PNEUMOVAX (LOT# 661577/1161X). First dose was given on 7-NOV-2003. It was reported that the patient developed a lump the size of a quarter the day of the vaccination. The next day 3/4 of the upper arm was red and warm. At the time of reporting it is unknown if the patient recovered. No further information is available.									U	11/19/2008	11/19/2008	0	None	OTH	OTH	FOSAMAX; amlodipine; aspirin; ALTACE; ZOLOFT; ZOCOR	Hypertension; Hypercholesterolaemia	Thyroid nodule; Lung nodule		WAES0811USA03709	1						1	Injection site cellulitis; Injection site erythema; Injection site reaction; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~89124~3~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1161X~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0354110	08/06/2009	PA	72.0			F	07/30/2009	Information has been received from a consumer concerning a 72 year old female patient with penicillin allergy and codeine allergy and a history of Raynaud's and emphysema who on 14-OCT-2008 was vaccinated with PNEUMOVAX (lot 661529/0868X). Concomitant therapy included Influenza virus vaccine (unspecified) on the other arm with no reaction, PROCARDIA and an inhaler. Prior vaccinations included a pneumonia vaccine (manufacturer unknown) 10 years ago. On 15-OCT-2008 the patient started experiencing headache, joint pain, loss of appetite and just feeling sick all over. The patient's arm also swelled up and was 3 times the size and very painful and red. After the swelling subsided the patient had bruising at the elbow area. The patient started taking BENADRYL and steroids. The patient also started developing a rash on her arm and started loosing weight. The patient eventually developed a viral infection in her lungs. The patient was finally getting over the infection and started feeling much better but is not yet fully recovered. The patient had sought unspecified medical attention. Additional information has been requested.									N	10/14/2008			None	OTH	OTH	[therapy unspecified]; PROCARDIA	Penicillin allergy; Drug hypersensitivity	Raynauds; Emphysema		WAES0811USA03825	1						1	Arthralgia; Contusion; Decreased appetite; Erythema; Headache; Malaise; Oedema peripheral; Pain in extremity; Rash; Viral infection; Weight decreased	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~Arm~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0868X~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0354146	08/06/2009		60.0			U	07/30/2009	Information has been received from a nurse concerning a 60-year-old patient who on 18-NOV-2008 was vaccinated with a dose of 0.5 ml PNEUMOVAX (lot #, route and injection site unknown). Concomitant vaccination also included injection of influenza virus vaccine (unspecified) in separate arm. ON 19-NOV-2008 the patient experienced an abnormally swollen arm at injection site over the entire arm. It was unknown if the patient sought any medical attention. The patient's outcome was unknown. This is one of several reports received from same source. Additional information has been requested.									U	11/18/2008	11/19/2008	1	Unknown	OTH	OTH			Unknown		WAES0812USA00288	1						1	Injection site swelling; Oedema peripheral	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~Arm~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0354151	08/06/2009	CA	67.0	67		F	07/30/2009	Information has been received from a pharmacist concerning a 67 year old female with penicillin and quinolones allergies, who on 17-NOV-2008 was vaccinated with PNEUMOVAX (Lot # 658074/0916U). Concomitant therapy included influenza virus vaccine (unspecified). The pharmacist reported that the patient developed redness and swelling of her right arm at the injection site that extended down to her forearm after receiving the vaccine. This is the third time the patient has received the vaccine. The dates of the first two doses were unspecified. The pharmacist requested a lot check. At the time of the report, the patient was recovering. The patient sought medical attention at the physician's office. A standard lot check was performed on the Lot # 0961U All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center and was released. Additional information has been requested.				Y					N	11/17/2008	11/17/2008	0	Unknown	OTH	OTH		Penicillin allergy; Drug hypersensitivity			WAES0812USA00573	1						1	Injection site erythema; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0961U~3~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0354157	08/06/2009	FL	69.0	69		F	07/30/2009	Information has been received from a medical assistant concerning a 69 year old female patient who on 01-OCT-2008 was vaccinated with the first dose of PNEUMOVAX (Lot# 660717/0224X). On 02-OCT-2008 the patient had a swollen arm that was warm to touch. The patient contacted her primary care physician and was sent to wound care. The patient was given antibiotics and as of 24-NOV-2008, was improving. Follow up information received from a physician reported that the patient with sulfonamide allergy received the dose of PNEUMOVAX on the left deltoid. Concomitant therapy included influenza virus vaccine (unspecified) on the left deltoid. There was no acute illness at the time of the vaccination. The reaction site had to be treated in the wound care center for an incision and drain (I &D) and debridement of the site. The patient recovered on 04-DEC-2008. Additional information is not expected.				Y					Y	10/01/2008	10/02/2008	1	None	PVT	OTH		Sulfonamide allergy			WAES0811USA03983	1						1	Debridement; Incisional drainage; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0224X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0354159	08/06/2009	ID				M	07/30/2009	Information has been received from a registered nurse concerning a male patient who on unspecified date was vaccinated with a 0.5 ml single dose of PNEUMOVAX 23. Concomitant therapy included influenza virus vaccine (unspecified) received in the other arm. The nurse reported that within 24 hours the patient experienced quite a bit of cellulitis (red and hot) on her upper arm and that she recommended to the patient to go home, apply heat to the affected area and take some ADVIL for the discomfort. The nurse also reported that there was no systemic reaction to the PNEUMOVAX 23, only localized reactions. At the time of the report the patient is recovering. This is one of two cases from the same source. Additional information has been requested.				Y					N				Unknown	OTH	OTH			Unknown		WAES0811USA03990	1						1	Cellulitis; Erythema; Local reaction; Skin warm	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~Arm~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0354169	08/06/2009	OR	56.0	56		F	07/30/2009	Information has been received from a nurse concerning a 56-year-old patient who on 17-NOV-2008 was vaccinated with a dose of 0.5 ml PNEUMOVAX (lot # 658673/0990U, route and injection site unknown).  Concomitant vaccination included a separate injection of influenza virus vaccine (unspecified).  Subsequently the patient experienced an abnormally swollen arm at injection site, described as worst they have even seen, and over the entire arm.  The patient sought unspecified medical attention.  At the time of reporting, the patient's symptom improved.  Follow-up information has been received from the nurse concerning the patient, who was a 56-year-old female with no known relevant medical history.  On 17-NOV-2008 she was vaccinated with the first fose of PNEUMOVAX (lot # 658673/0990U) via subcutanous route in her right arm.  Concomitantly she also  received a yearly dose of FLUZONE (lot # U2771AA)  IM in her right arm.  On 20-NOV-2008, the patient experienced intense swelling, redness, local pain and itching.  The are affected had a size of a hand.  It had  sharp line of demarcation and was erythematous.  She was treated with  ALLEGRA 180 mg and AUGMENTIN 875 mg.  No laboratory tests were performed. On an unspecified,date, the patient recoreved from the events. This is one of several reports received from the same source.  No further information is available.									Y	11/17/2008	11/20/2008	3	None	PVT	PVT	Unknown		None		WAES0812USA00035	1						1	Injection site erythema; Injection site pain; Injection site pruritus; Injection site swelling; Oedema peripheral	FLU3~SANOFI PASTEUR~U2771AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0990U~1~SC~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0354176	08/06/2009	NH	37.0	37		M	07/30/2009	Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of PNEUMOVAX 23 on an unspecified date (lot #659485/1715U). Subsequently the patient experienced severe arm pain, tingling, numbness and swelling on an unspecified date. No cellulitis reported. The outcome was unknown at the time of reporting. Follow up information was received concerning a 37 year old male patient with asthma and allergy to penicillin and E-MYCIN who was intramuscularly vaccinated with the first dose of PNEUMOVAX 23 at 9:00 on 04-NOV-2008 into the right deltoid. ON the same day the patient also was intramuscularly vaccinated with the first dose of FLUARIX into the right deltoid. There was no illness at the time of vaccination. At 11:00 on 04-NOV-2008 the patient experienced severe arm pain and required emergency room/doctor visit. No treatment was given. The reporter considered this case was due to FLUARIX not PNEUMOVAX 23. The outcome was not provided. Follow up information was received concerning the male patient who experienced severe arm pain with numbness and tingling on 04-NOV-2008. He recovered from severe arm pain with numbness and tingling on unspecified dates. This is one of several reports from the same source. Additional information has been requested.									Y	11/04/2008	11/04/2008	0	None	PVT	PVT	Unknown	Asthma; Penicillin allergy; Allergic reaction to antibiotics			WAES0812USA01977	1						1	Hypoaesthesia; Pain in extremity; Paraesthesia; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1715U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0354220	08/06/2009	CA	58.0	58		F	07/30/2009	Information has been received from a physician concerning a 58 year old white female patient with allergic reaction to KEFLEX and sulfonamide allergy, and lung cancer stage 4 who on 14-OCT-2008 was vaccinated with PNEUMOVAX (lot # 659148/1382U) IM in the left arm.  Concomitant therapy included first dose of FLUZONE (lot # 02751AA) IM in the left arm.  On 15-OCT-2008 the patient experienced swollen left arm and arm redness.  Subsequently, the patient recovered from left arm swollen and arm redness.  Additional information has been requested.									Y	10/14/2008	10/15/2008	1	Unknown	PVT	OTH		Lung cancer stage IV;  Allergic reaction to antibiotics;  SULFONAMIDE allergy			WAES0812USA05189	1						1	Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~02751AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1382U~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0354229	08/06/2009	NJ	83.0			F	07/30/2009	Information has been received from a physician concerning an 83 year old female patient with chronic obstructive pulmonary disease and arthritis and a history of breast cancer who on 24-OCT-2008 was vaccinated intramuscularly in the hip with a dose of PNEUMOVAX (lot # 661529/0868X).  Concomitant therapy included influenza virus vaccine (unspecified).  The patient called the office on 01-DEC-2008 complaining of discomfort in the hip near the injection site.  Injection was given in the hip because the patient had a mastectomy with lymph involvement previously.  She was given a flu shot (manufacturer unknown) in her good arm at the same visit on 24-OCT-2008 so the decision was made to give the dose of PNEUMOVAX in the hip.  It was unknown when the discomfort started.  Upon examination by the physician in December 2008 the area was minimally tender with no warmth, erythema, or induration.  The patient's husband reported the area was warm.  Physician asked for a lot check on 661529/0868X.  The patient sought unspecific medical attention.  At the time of the report the patient was not recovered.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the agency and was released.  Additional information has been requested.				Y					N	10/24/2008			None	OTH	OTH		Chronic obstructive pulmonary disease;  Arthritis	Mastectomy		WAES0812USA03348	1						1	Injection site discomfort; Skin warm; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0868X~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0354255	08/06/2009		81.0			F	07/30/2009	Information has been received from a nurse concerning an 81 year old female who on an unknown date, was vaccinated with PNEUMOVAX (lot# not provided). Concomitant therapy included Influenza virus vaccine (unspecified). Subsequently the patient experienced a swollen red, feverish arm which was diagnosed as cellulitis. The patient was advised to use warm compresses, TYLENOL and BENADRYL. At the 2 week follow up, the symptoms had resolved. Unspecified medical attention was sought. This is one of several reports from the same source. Additional information has been requested.									Y				Unknown	OTH	OTH			Unknown		WAES0901USA01996	1						1	Cellulitis; Erythema; Oedema peripheral; Skin warm	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0354331	08/06/2009	OR	69.0	69		F	07/30/2009	Information has been received concerning a 69 year old female patient, who weights 210 pounds and is 64 1/4 inches tall, and has no pertinent medical history or known drug allergies, who on 18-NOV-2008 was vaccinated with a dose of PNEUMOVAX (lot# 658673/0990U) subcutaneously and with a dose of FLUZONE (influenza virus split virion 3v vaccine inactivated) lot # U2771AA) intramuscularly.  On 18-NOV-2008 the patient experienced pain, erythema 5 to 7 cm redness, joint aches and muscle aches.  Patient was seen in the office twice.  No laboratory diagnostic studies performed.  Patient was treated with Ranitidine and Allegra 60 mg for 2 weeks.  At the time of this report patient had recovered.  No further information is available.				Y					Y	11/18/2008	11/18/2008	0	None	PVT	PVT	Unknown		None		WAES0901USA03163	1						1	Arthralgia; Erythema; Myalgia; Pain	FLU3~SANOFI PASTEUR~U2771AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0990U~UNK~SC~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0354603	08/06/2009					U	07/30/2009	Information has been received from an office manager concerning a patient who on an unknown date, was vaccinated with PNEUMOVAX 23 (lot# not reported). Concomitant therapy include influenza virus vaccine (unspecified). Subsequently the patient experienced something like an anaphylactic response. Unspecified medical attention was sought. Additional information has been requested.									U				Unknown	OTH	OTH			Unknown		WAES0902USA01832	1						1	Anaphylactic reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0354170	08/07/2009	NC	67.0	67		F	07/30/2009	Information has been received from a registered nurse concerning a 67 year old female with asthma, cholesterol high, type 2 diabetes mellitus, arthritis and PENICILLIN allergy and a history of pneumonia who on 24-NOV-2008 was vaccinated with the second dose of PNEUMOVAX, IM (lot# 662662/0979X).  The date of the first vaccination was unknown.  Concomitant therapy included influenza virus vaccine (manufacturer unknown) administered in opposite arm and other unspecified medications.  On 24-NOV-2008 the patient experienced a local reaction including redness, swelling, and warmth to touch.  On 25-NOV-2008 the patient was seen in office and prescribed BENADRYL and IBUPROFEN.  Follow up information has been received from the registered nurse who reported that on 24-NOV-2008, the patient received the first dose of PNEUMOVAX, IM (lot# 662662/0979X) (initially reported as the second dose by the same reporter).  The patient's erythema and swelling at injection site was 4-5cm in diameter.  The patient was treated with ice and NSAID (nonsteroidal anti-inflammatory drug).  Subsequently, the patient recovered.  Additional information is not expected.				Y					Y	11/24/2008	11/24/2008	0	None	PVT	PVT		Asthma;  Cholesterol high;  Type 2 diabetes mellitus;  Arthritis;  Penicillin allergy	Pneumonia		WAES0812USA00052	1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~Arm~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0979X~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0353489	08/08/2009	IN	24.0	24		M	08/08/2009	Sweating, chills,  headache, head congestion, blurry vision, dizziness, chest pain, heart palpitations, congestive heart failure, tinnitus, postural tachycardia, loss of appetite, fatigue, fever (1 week) followed by low body temperature, weight loss, brain fog, jaw pain, TMJ, swollen lymph nodes, nausea, suppressed immune function.  8/11/09 Cardiology consult records received DOS 7/16/09 to 3/12/09. Assessment: History of chronic babesiosis and mild non-ischemic cardiomyopathy, left posterior fascicular block.  Patient reports that he had endocarditis that began after flu shot. Presents with vague left anterior chest pain with radiation into left arm. Dyspnea on exertion, palpitation, and near syncope. Fatigue. Weight loss, generalized lymphadenopathy, poor appetite. Eye pain. Dizziness and lightheadedness. Limited lifestyle. 9/29/09 Medical records received from ID physician for date range: 11/9/08 to 8/28/09. Patient presents with positive testing for Lyme Disease and babesia infection. C/O fatigue night sweats, blurred vision, poor sleeping, weight loss, easy brusing, pale in color, HA, head throbbing and pressure, right side jaw clenching, tinnitus, hair loss, SOB, chest pain, heart palpitations, N/V, constipation. DX: Neurologic Lyme Disease and babesia, elevated murcury level, heavy metal positive. TX with multiple IV medications.    10/30/09 Medical records received for DOS 11/06/06-11/30/06. Developed weakness and decreased vision/vision changes in R eye s/p vaccine.  Multiple PCP visits for fatigue and visual changes s/p vaccine.Viral syndrome.  Nausea, early satiety and weight loss. Maxillary sinusitis. Head CT otherwise normal. Vision 20/20. Neuro WNL.  H/O increased HGB. Decreasing. Developed diar on abx therapy for sinusitis. Probable c. diff. ED visit for weakness and visual changes. PE WNL. Labs WNL. Etiology unclear.			Y	Y	Y	12	Y	Y	N	11/01/2006	11/02/2006	1	Comprehensive metabolic, DNA, infectious, and chemical blood testing, echocardiogram, CT scans, MRI's, heavy metal testing.11 8/11/09 Cardiology consult records received DOS 7/16/09 to 3/12/09. LABS and DIAGNOSTICS: ECG - Sinus rhythm with rightward axis, diffuse upsloping ST changes. Echocardiography - LVEH at 45-50%. EKG Stress Treadmill - Negative. 9/29/09 Medical records received from ID physician for date range: 11/9/08 to 8/28/09 Labs: positive murcury level/heavy metals. Labs & Diags: CMP, TSH, CT head all WNL. RPR non reactive. Hep panel neg. ANA  neg. HGB 18.9 (H).	UNK	UNK	None	None.	None. Babesiosis (babesia duncani). 8/11/09 Cardiology consult records received DOS 7/16/09 to 3/12/09. Pancarditis. CHF. Allergy to ChloraPrep. Endoscopy. Hypertensive heart disease.  9/29/09 Medical records received from ID physician for date range: 11/9/08 to 8/28/09 PMH: Lyme Disease, Babesia, EBV as a child/teen.   PMH: increase HGB and HCT. Mono.  Allergies: None.			1						1	Anorexia; Blood heavy metal test; Blood test; Body temperature decreased; Cardiac failure congestive; Chest pain; Chills; Computerised tomogram; DNA antibody; Dizziness; Echocardiogram; Fatigue; Feeling abnormal; Headache; Hyperhidrosis; Immune system disorder; Laboratory test; Lymphadenopathy; Metabolic function test; Nausea; Nuclear magnetic resonance imaging; Pain in jaw; Palpitations; Postural orthostatic tachycardia syndrome; Pyrexia; Sinus congestion; Temporomandibular joint syndrome; Tinnitus; Vision blurred; Weight decreased	FLUX~SANOFI PASTEUR~U2217AA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0353494	08/09/2009	CA	1.0	1	.0	F	08/09/2009	After first vaccination (Hepatitis B) - Colic, sleeplessness, irritability. Same following next several vaccinations, followed by cognitive skill delays, speech delays, social delays and restrictive interests. Increased delays following last vaccinations given on 10/11/2006. Finally diagnosed with Autism at 23 months old. Course of treatment was ABA, OT and Speech therapy, along with GFCF diet and other biomedical treatments.  8/21/09 Psych/Autism consultation records received DOS 9/12/07. Assessment: Pervasive Developmental Disorder, Not Otherwise Specified. Parents are concerned about language delay. Does not respond to name or understand what is said to her. Impaired peer relationships, social and emotional reciprocity. Spins in circles. Temper tantrums. She presents with 3 cafe' au lait birthmarks.								Y	N	10/11/2006	10/12/2006	1	8/21/09 Psych/Autism consultation records received DOS 9/12/07. LABS and DIAGNOSTICS: Autism Diagnostic Observation Schedule - Abnormal. Developmental Assessment - Abnormal. Pending: DNA for Fragile X, Karyotyping, Mecury Levels, Lead Levels. Genetic Evaluation.	UNK	UNK	none	none	none	social withdrawl/speech delays/conitive delays~Measles + Mumps + Rubella (no brand name)~1~1.10~Patient		1						1	Abdominal pain; Autism; Cognitive disorder; Developmental delay; Insomnia; Irritability; Social avoidant behaviour; Speech disorder developmental	FLU3~AVENTIS PASTEUR~U2105FA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0499F~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0911F~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Disabling	Influenza
0228345	08/10/2009	MI	80.0			M	08/06/2009	From initial information received on 10/Nov/2004 from the FDA (VAERS # 228345-1), it was reported that an 80-year-old male patient received a FLUZONE SV '2004-'2005 USP vaccination, lot number U1478AA, on 14/Oct/2004. Order written for 1cc Flu vaccine; documented administration same, though facility says patient actually received 0.5cc. Four days later, on 18/Oct/2004, dark, cloudy urine was noted. A urinalysis was ordered and urine was collected on 20/Oct/2004. The results were not available until 24/Oct/2004 which showed numerous proteus mirabilis, sensitivities were also noted. No orders for antibiotics were noted in the patient's records. On 22/Oct/2004 at 2:10 pm the patient was found in the bathroom unresponsive and pale with no pulse, no respiration and no blood pressure. CPR was initiated but was unsuccessful. According to the patient's medical records the only recent acute medical problem revealed was a urinary tract infection. Per the director of the nursing facility an autopsy was not done on the patient. The reporter of this case is the same reporter of cases 2004-03647, 2004-03648 and 2004-03649. All four cases came from the same Long Term Care facility. From additional information received on 16/Nov/2004 from an internal e-mail communication from a VAERS Nurse researcher, it was reported that the death certificate was received. The cause of death was listed as hypertension and cerebral vascular accident. No other information was provided. Additional information concerning this patient was received on 27 July 2009 from a literature citation. Purpose: To evaluate a possible association between influenza vaccination and four deaths and four serious illnesses among 114 recent influenza vaccinees in a long-term care facility (LTCF) and two deaths from a nearby physician's office. All had received vaccine from the same lot (Lot A). Methods Field investigation including (1) a retrospective cohort study among LTCF residents who received Lot A or other influenza vaccine, (2) review of medical records of cases of death or serious illness, (3) active surveillance of death among 1500 community based Lot A vaccinees and (4) laboratory testing of vaccine from available Lot A vials. Results Medical record reviews showed no common clinical syndrome or cause of death. Laboratory testing of Lot A samples revealed no evidence of tampering and no differences compared to an unrelated lot. The risk of death or hospitalization was not significantly different between persons who received Lot A versus a comparison lot, Lot B (incidence rate ratio (IRR) = 0.9, 95%CI = 0.3-3.3). Conclusions There was no clinical or biological evidence pointing to inherent vaccine safety issues, nor was there a detectable increased risk of death or hospitalization among persons vaccinated with Lot A. Lot specific clustering of adverse events (AEs) may reflect medical events causally unrelated to vaccination. Rapid investigations of potential AEs are  important to ensure vaccine safety and to maintain pubic and healthcare provider confidence in vaccines. An 80 year old patient with a medical history of a colon cancer, arthritis, hypertension, obstructive sleep apnea, hypokalemia, diverticulosis and obesity. The patient developed cloudy urine four days post vaccination. Eight days post vaccination the patient died. According to the death certificate, cause of death was hypertension and CVA. No additional information was provided. The following case was also associated with this literature article 2009-03219.	Y	10/22/2004							N	10/14/2004	10/22/2004	8	24/Oct/2004: Urinalysis showed numerous proteus mirabilis, sensitivities also noted.	UNK	UNK	BUMETANIDE; CELEBREX; DOCUSATE SODIUM; FLOMAX; POTASSIUM CL; MECLIZINE; PREVACID		The patient has a recent medical history of a urinary tract infection. The patient has a past medical history of colon cancer, arthritis, vertigo, obstructive sleep apnea, hypertension, benign prostatitis, hypokalemia, diverticular disease and obesity.		200403646	1						2	Blood pressure immeasurable; Cerebrovascular accident; Death; Hypertension; Pallor; Proteus infection; Pulse absent; Respiratory arrest; Unresponsive to stimuli; Urine abnormality; Urine analysis abnormal; Urine colour abnormal	FLU3~SANOFI PASTEUR~U1478A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0228346	08/10/2009	MI	75.0			M	08/06/2009	From initial information received on 10/Nov/2004 from the FDA (reference number 228346-1) regarding an adverse event occurring, it was reported that a 76-year-old male patient received 1cc of FLUZONE SV '2004-'2005 USP vaccine, lot number U1478AA, administered on 14/Oct/2004. Two days later on 16/Oct/2004 the patient's vital signs were as follows: blood pressure 140-50, temperature 96.6 degrees Fahrenheit, the patient complained of feeling tired. At 1:00pm that same day the patient refused his lunch as his stomach was upset, his skin was white, dry and pale. At 2:25pm that afternoon while the patient was being assisted to bathroom in his wheelchair he slumped over and had no vital signs. Per the director of the nursing home an autopsy was not performed on the patient. The most recent medical records included a discharge summary for an inpatient stay from 06/Sep/2004 to 09/Sep/2004 at a local hospital. The diagnosis on discharge was bilateral lower extremity cellulitis, possible bacteremia, DM type two, hyperlipidemia, depression, coronary artery disease, atrial fibrillation, congestive heart failure, lymphedema, chronic renal insufficiency, venous stasis ulcers and gout. The reporter of this case is the same reporter of cases 2004-03646, 2004-03648 and 2004-03649. All four cases came from the same Long Term Care facility. From additional information received on 16/Nov/2004 from an internal e-mail communication from a VAERS nurse researcher, it was reported that the death certificate was received. The cause of death was listed as coronary artery disease and congestive heart failure. No other information was provided. Additional information concerning this patient was identified on 27 July 2009 from a literature citation: Purpose: To evaluate a possible association between influenza vaccination and four deaths and four serious illnesses among 114 recent influenza vaccines in a long-term care facility (LTCF) and two deaths from a nearby physician's office. All had received vaccine from the same lot (Lot A). Methods Field investigation including (1) a retrospective cohort study among LTCF residents who received Lot A or other influenza vaccine, (2) review of medical records of cases of death or serious illness, (3) active surveillance of deaths among 1500 community based Lot A vaccinees and (4) laboratory testing of vaccine from available Lot A vials. A samples revealed no evidence of tampering and no differences compared to an unrelated lot. The risk of death or hospitalization was not significantly different between persons who received Lot A versus a comparison lot, Lot B (incidence rate ratio (NRR) = 0.9, 95%CI = 0.3-3.3). Conclusions There was no clinical or biological evidence pointing to inherent vaccine safety issues, nor was there a detectable increased risk of death or hospitalization among persons vaccinated with Lot A. Lot specific clustering of adverse events (AEs) may reflect medical events causally unrelated to vaccination. Rapid investigations of potential AEs are most important to ensure vaccine safety and to maintain public and healthcare provider confidence in vaccines. A 75 year old patient had a history of diabetes mellitus, hypercholesterolemia, anemia, depression, coronary artery disease, atrial fibrillation, congestive heart failure, lymphedema, chronic renal insufficiency, and gout. The patient began coughing and became lethargic one day prior to vaccination. Two days post vaccination the patient died. According to the death certificate, the cause of death was CAD and CHF. No additional information was provided. The following case was also associated with the literature article 2009-03219.	Y	10/16/2004							N	10/14/2004	10/16/2004	2	Lab data: 12/Oct/2004- CBC: WBC 17.4, RBC 2.85, Hgb 8.2, MCV 89, MCH 28.8, MCHC 32.3, Platelet count 310, Lymphocyte 8, Pro time 25.9, INR 2.1	UNK	UNK	HUMULIN; ZOMIG; Ferrous sulfate; LOPRESSOR; LOPID; SENOKOT; MICRO K; METAMUCIL; LEXAPRO; CARDIZEM; BUMEX; ARANES; PROTONIX; Allopurinol; NITRO PATCH; COUMADIN; Clindamycin; ASA; GLUCOPHAGE; OSCAL		The patient has a past medical history of diabetes mellitus, hypercholesterolemia, hyperlipidemia, anemia, depression, coronary artery disease, atrial fibrillation, congestive heart failure, lymphedema, renal insufficiency, gout, and hematuria. The patient has allergies to penicillin and ether. At the time of the vaccination the patient had resolving cellulitis. The most recent medical records included a discharge summary for an inpatient stay from 06/Sep/2004 to 09/Sep/2004 at a local hospital. The diagnosis on discharge were bilateral lower extremity cellulitis, possible bacteremia, DM type two, hyperlipidemia, depression, coronary artery disease, atrial fibrillation, congestive heart failure, lymphedema, chronic renal insufficiency, venous stasis ulcers and gout. A spinal film was done with results on 12/Oct/2004 showing minimal compression fracture of the thoracic spine with a question of old vs. new. On 13/Oct/2004 the patient complained of feeling too warm and sweaty and asking for an insulin shot. His blood sugar was 200 (no unit reported). One day pre vaccination the patient was coughing and lethargic.		200403647	1						2	Abdominal discomfort; Cardiac failure congestive; Coronary artery disease; Death; Decreased appetite; Diet refusal; Dry skin; Fatigue; Haemoglobin decreased; International normalised ratio increased; Lymphocyte count increased; Mean cell haemoglobin concentration normal; Mean cell haemoglobin normal; Mean cell volume normal; Pallor; Platelet count normal; Prothrombin time prolonged; Red blood cell count decreased; Wheelchair user; White blood cell count increased	FLU3~SANOFI PASTEUR~U1478A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0353556	08/10/2009	TX	57.0	57		F	03/10/2009	After immunization, patient developed paresthesia of all limbs. 8/19/09 Neuro consults received dated 12/15/2008 with dx:  Paresthesias of the hands and feet, likely mild peripheral neuropathy r/t immunization.  Pt presented with c/o onset of sensation of vibration in the hands/feet shortly after receiving flu vax. Pt initially developed flu-like sx then the onset of vibration. PE (+) for diminished reflexes.				Y					N	10/17/2008	10/20/2008	3	EMG reveals a sensory peripheral neuropathy Labs and diagnostics:  EMG abnormal.  Protein electrophoresis WNL.	OTH	PUB	CLARITIN; LIPITOR; FLONASE; BENADRYL	None	Allergies, Arthritis, Asthma, Migraines PMH:  dyslipidemia, tachycardia, MVP, H/A, migraines. asthma, carpal tunnel, restless legs, Vit D deficiency, shingles,arthritis.allergies: PCN, sulfa, EES, NSAIDS and other meds			1						1	Electromyogram abnormal; Paraesthesia; Peripheral sensory neuropathy	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA374AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0353557	08/10/2009	FL	1.2	1	.2	F	08/03/2009	Temp on & off X 4 days, rash on back and neck X 1 wk and spreading.				Y					Y	01/13/2009	07/27/2009	195	None	PVT	PVT		None				1						1	Body temperature fluctuation; Rash	FLU3~SANOFI PASTEUR~UT2794GA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1365X~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1380X~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0353580	08/10/2009	CA	15.0	15		F		Patient fainted and fell to the floor, soon after receiving immunizations.									Y	02/13/2009	02/13/2009	0	Head CT Scan; Head MRI; EEG; Neurology consult; Cardiology consult.	PUB	OTH		None	Previous history of fainting episodes			1						1	Computerised tomogram; Electroencephalogram; Fall; Nuclear magnetic resonance imaging; Syncope	FLU3~GLAXOSMITHKLINE BIOLOGICALS~89985~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAV258AA~UNK~IM~UN~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~0381X~UNK~IM~UN~HPV (GARDASIL)~1|VARCEL~GLAXOSMITHKLINE BIOLOGICALS~1328X~UNK~SC~UN~VARICELLA (VARILRIX)~1	USA		Influenza
0353794	08/11/2009	CA	24.0	24		U	08/11/2009	Arrythmia, Rapid Heart Rate, Excessive Sweating, Shortness of breath. Dehydration. Had to go to hospital and have my baby montored as I was pregnant. I was told I was dehydrated per the excessive sweating. Also was at the cardiologist numerous times after vaccination. Was diagnosed with arrythmia am still being treated for it. This all happened 4 days after vaccination.				Y	Y	1				11/03/2008	11/07/2008	4		PVT	UNK	none	no	none	Arrythmia, Rapid Heart Rate, Excessive Sweating, Shortness of breath. Dehydration.~Influenza (Seasonal) (Fluvirin)~1~24.80~In Pa		1						1	Arrhythmia; Dehydration; Drug exposure during pregnancy; Dyspnoea; Heart rate increased; Hyperhidrosis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~8811002~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0353811	08/11/2009	TX	3.0	3		M	08/11/2009	Given R upper lat leg - VARIVAX - 4 d ago. Redness- serpentigenous.									U	08/07/2009	08/08/2009	1		PVT	PVT	MIRALAX					1						1	Injection site erythema; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500673P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~0857Y~2~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0353799	08/12/2009	CA	59.0	59		M	08/11/2009	I had a flu vaccine on 10-18-26 on the advise of my Doctor.  I noticed no adverse effects until 01-17-2007, when my wife discovered me down on the bedroom floor moaning she woke me and dressed me. I couldn't walk or hold things.  Sh managed to get me to the Hospital where I was incubated and admitted to the hospital.  I do not remember what occurred the next week or two I did end up having advanced physical therepy.  I could not walk or get up or out of bed on my own after about 40 days I was released to home therapy			Y	Y	Y	40	Y		U	10/18/2006	01/17/2007	91	I had extensive lab work done, blood, urine, xrays, etc	UNK	UNK	none	none	failed back syndrome, chronic pain syndrome, alergic to methadone, morphine			1						1	Abasia; Blood test; Endotracheal intubation; Fall; Grip strength decreased; Laboratory test; Moaning; Urine analysis; X-ray	FLU3~SANOFI PASTEUR~20062007MDV~2~ID~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0353920	08/12/2009		21.0	21		F	08/12/2009	This case was reported by a physician, via another manufacturer (Amgen, # KDL345560) and described the occurrence of bone marrow failure in a 21-year-old female subject who was vaccinated with Influenza vaccine (manufacturer unspecified). The subject's medical history included multiple kidney biopsies, right internal jugular tunneled dialysis catheter placement complicated by vessel damage and traumatic pneumothorax treated with chest tube placement, and living related kidney transplant. Concurrent medical conditions included occasional alcohol use, left upper arm arteriovenous fistula, bone metabolism disorder, chronic allograft nephropathy, dry skin, end stage renal disease secondary to congenital renal dysplasia nos, short-term hemodialysis, high blood pressure, hyperparathyroidism, hyperphosphatemia, metabolic acidosis, and short stature. On an unknown date in 2008, the subject started PROCRIT 5000 units (U) twice a week; exact date, route and baseline hemoglobin (Hgb) were not provided. After an unspecified time of exposure, approximately in May 2008, the subject started experiencing an increase in creatinine (values were not provided). About four months later, on 30 August 2008, creatinine rose to 6.2 and blood urea nitrogen (BUN) was 78. That same day, the subject's Hgb increased to 15, and PROCRIT therapy was temporarily discontinued. Approximately two and a half weeks later, on 19 September 2008, the subject started experiencing failing of renal transplant and mild metabolic acidosis; Hgb was 14 and creatinine was 5.4. Treatment with sodium bicarbonate orally for metabolic acidosis was initiated. About five days later, on 26 September 2008, the subject experienced a decreased Hgb to 11.9, and one week later, on 03 October 2008, PROCRIT therapy was resumed at 10000 U subcutaneously (SC) every two weeks. Co-suspect medication included Epoetin alfa (PROCRIT and EPOGEN brands). Concurrent medications included Paricalcitol, PHOS-LO, Prednisone, Amlodipine, Heparin, CICLOSPORIN, Dextriferron, CALCITROL, Sodium bicarbonate, Zolpidem tartrate, Laxatives and Mycophenolate mofetil. On 24 October 2008 the subject received unspecified dose of Influenza vaccine (details unknown). On the same date (24 October 2008) blood test showed Hgb of 11.3 (it was not specified whether the test was performed before or after vaccination). It was reported that the subject's anemia was stable and the subject had good response to PROCRIT. Later that same month, the subject experienced worsening of kidney function with more significant acidosis, hyperkalemia, hyperphosphatemia and pedal edema; creatinine was 6.3, BUN was 66, potassium was 5.2, and phosphorus was 5.8. The hepatitis B surface antigen test was negative. The following month, in November 2008, the subject experienced allograft failure. On 05 November 2008, Hgb was 10.1 g/dl, white blood cell count (WBC) was 11.95x1000/mcL, platelet count, was 443x1000/mcL, transferrin saturation was 11 percent, serum folate was greater than 24 ng/mL, creatinine was 6.1 mg/dL, BUN was 72 mg/dL, bicarbonate was 17 mEq/L, aluminum was less than 5 mcg/L, intact parathyroid hormone (i-PTH) was 202 pg/mL and hepatitis C (anti-HCV) test was negative. The subject initiated hemodialysis with iron therapy, and immunosuppressive agents (ciclosporin, mycophenolate mofetil and prednisone) started tapered off. Two days later, on 07 November 2008, the subject was switched to EPOGEN at 6600 U intravenously (IV) three times a week (TIW) for an unspecified reason; Hgb was 10.1. Approximately two weeks later, on 19 November 2008, Hgb was 10.5. Four days later, on 23 November 2008, EPOGEN therapy was increased to 8000 U. Ten days later, on 03 December 2008, Hgb was 12.2. EPOGEN was continued. Over the following one month two and a half weeks, Hgb rose to 14.7. Two days later, on 23 January 2009, EPOGEN was temporarily discontinued. That same month, ciclosporin therapy was discontinued as well. The next month, on 06 February 2009, Hgb was 16.8, WBC was 10800, platelet count was 232000, creatinine was 5.91, BUN was 36, glomerular filtration ratio (GFR) was 9. On an unknown date later, the subject developed erythematous rash. Treatment included moisturizers and an antifungal agent with improvement. Subsequently, in mid-February 2009, the subject experienced acute gastrointestinal illness with abdominal pain and diarrhoea lasted for about twenty four hours. Treatment details were not provided, and two days later the event resolved. The reporter stated that around the same time prednisone therapy was discontinued. Subsequently, on 25 February 2009, Hgb decreased to 12, and EPOGEN was resumed at 4000 U IV TIW. Over the following three weeks, Hgb ranged from 10.7 to 10, and EPOGEN dose was incrementally increased to 5800 U IV TIW; platelet count 256-266 1000/mcl, WBC was 4.14 x1000/mcL, serum ferritin was 810 ng/mL, serum iron was 206 mcg/dL, unsaturated iron binding capacity (UIBC) was 42 mcg/dL, transferrin saturation was 83%, creatinine was 7.1 mg/dL, BUN was 36 mg/dL, urea reduction ratio was 83%, i-PTH was 748.9 pg/mL and hepatitis B surface antigen test was negative. It was reported that in March 2009 paricalcitol therapy was initiated, and immunosuppression therapy was discontinued. On 25 March 2009, Hgb was 6.7, and the reporter stated that anemia became unresponsive to epoetin therapy. Treatment details were not provided. Around the same time, the subject started experiencing tiredness when walking upstairs and subsequently became increasingly fatigued and short of breath with exertion. Treatment details were not provided. On 30 March 2009, the dose of EPOGEN was further increased to 7600 U IV TIW. That same day, the subject experienced a low grade fever to 99.3 and was seen in the emergency room for fatigue and generalized weakness. Anemia work up revealed Hgb of 5.6. Treatment details were not provided. Outcome details of the event fever were not provided. The subject was subsequently hospitalized on 01 April 2009 for five days for anemia. That same day, blood test showed Hgb of 6, WBC of 2800, absolute neutrophil count of 1.2, platelet count of 283000, potassium of 3.2, CO2 of 32, creatinine of 2.51 and GFR of 24.2. Peripheral blood smear showed predominantly normochromic normocytic erythrocytes with rare target cells. No increased polychromasia, nucleated blood cells, erythrocyte fragments and microspherocytoses were observed. The white blood cells were decreased with no early white blood cell forms detected, and the neutrophils did not have increased granulation or vacuoles; no giant platelets were identified. Faecal occult blood test x1 was negative. Urinalysis revealed small blood, positive protein, positive leukocyte esterase, five to ten white blood cells and few bacteria. Urine culture showed no bacterial growth at 24 hours. EPOGEN therapy was increased to 24000 U IV TIW. Additional treatment details were not provided. The following day, on 02 April 2009, Hgb was 6, blood erythropoietin was 3607, WBC was 2.4, absolute neutrophil count was 1.3, platelet count was 242000, folate was 5.7, total protein was 6.3, chloride was 98, CO2 was 33, creatinine was 3.78, GFR was 15, thyroid stimulating hormone level was 22 and vitamin B12 was 1051. The subject was negative for serum parvovirus B19 antibodies, and the results of blood cultures x2 were pending. Repeated blood smear test showed significant artifact, and no increased red blood cell fragments were identified. The subject was diagnosed with hypoproliferative anemia and leukopenia. It was reported that the subject was reluctant to proceed with red blood cell transfusion due to concerns of alloimmunization compromising her changes for second transplant. Transfusion with red blood cells was planned for Hgb of 5.5 or less or in case of developing of worsening of symptoms. The subject also experienced abdominal pain, and a computed tomography scan of abdomen with oral and intravenous contrast was done. The results revealed focal fatty infiltrate within the liver adjacent to the falciform ligament and severely atrophic, and cystic kidneys. A left ovarian cyst and congenital deformity at the lumbosacral spine with dysgraphism were noted as well. The lung bases were clear. No acute intra-abdominal abnormality was identified. Treatment and outcome details were not provided. The subject also experienced hair loss. Treatment and outcome details were not provided. The next day, on 03 April 2009, Hgb was 5.5, WBC was 2.7, platelet count was 241, serum iron was 183, iron saturation was 93, total iron binding capacity was 196, transferrin was 140, ferritin was 630, creatinine was 6.31, BUN was 33, GFR was 8.3, total protein was 6.5 and phosphorus was 6. Hepatitis B core IgM, hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus 1 and human immunodeficiency virus 2 tests were negative. Cytomegalovirus DNA was not detected as well. Protein electrophoresis revealed no monoclonal proteins and decreased IgG and IgA components. For evaluation of the subject's shortness of breath computed tomography scan of the chest without the use of contrast was performed. The results showed a duplicated left superior vena cava extending along the left mediastinum to the left heart border, 8 mm hypodense lesion of left thyroid, constipation and atrophic kidneys consistent with end-stage renal disease; no pleural effusion, gross mediastinal or hilar adenopathy were detected; lungs were clear with no pneumothorax. No findings to explain the subject's shortness of breath were identified. That same day, the subject received two units of unspecified transfusion. The following day, on 04 April 2009, Hgb was 8.5, WBC was 3.5, platelet count was 228, creatinine was 4.72 and GFR was 11.7. Repeated faecal occult blood test was negative. Urine immunofixation electrophoresis showed a polyclonal increase in free kappa and/or free lambda light chains; no monoclonal free light chains (Bence Jones Protein) were identified. On 05 April 2009 Hgb was 8.4, WBC was 4.2, platelet count was 214, and the subject was discharged. The next day, on 06 April 2009, Hgb was 8, and EPOGEN therapy was decreased to 20000 U IV TIW. Over the following two and a half weeks, Hgb ranged from 6.8 to 9.1. The subject received two units of unspecified transfusion and required incremental increase in EPOGEN dose to 28000 U IV TIW. On 23 April 2009 bone marrow aspirate, clot sections and core biopsy revealed normocellular (60-70 percent) bone marrow with trilineage hematopoiesis, left shifted granulopoiesis, marked erythroid hyperplasia and mild megakaryocytic hyperplasia; increased storage iron; mild paratrabecular reticulin fibrosis, 1+/4+; no atypical non-hematopoietic cells or granulomas were identified, scattered erythroid and myeloid precursors were present. Peripheral blood smear revealed anemia and leukopenia. Flow cytometric analysis showed no significant immunophenotypic abnormalities. The pathologist commented that low grade myelodysplastic syndrome cannot be completely ruled out. Over the following ten days, Hgb steadily declined from 8.5 to 6.5, and EPOGEN therapy was permanently discontinued on 04 May 2009. Two days later, on 06 May 2009, Hgb was 6.1. The subject received two units of unspecified transfusion. The latest Hgb level on 08 May 2009 was 10.5; WBC was 5.1 and platelet count was 266. Antibody testing was requested. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. The physician stated that there was a reasonable possibility the event anemia was related to EPOGEN therapy. There was no causality statement provided for Influenza vaccine.				Y	Y				U	10/24/2008	04/23/2009	181	Blood albumin, 05Nov2008, below 5mcg/L; Blood bicarbonate, 05Nov2008, 17mEq/L; Blood chloride, 01Apr2008, 96; Blood chloride, 02Apr2009, 98; Blood creatinine, 24Oct2008, 6.3; Blood creatinine, 05Nov2008, 6.1mg/dL; Blood creatinine, 06Feb2009, 5.91; Blood creatinine, 11Mar2009, 7.1mg/dL; Blood creatinine, 01Apr2009, 2.51; Blood creatinine, 02Apr2009, 3.78; Blood creatinine, 03Apr2009, 6.31; Blood creatinine, 04Apr2009, 4.72; Blood erythropoietin, 02Apr2009, 3607; Blood folate, 05Nov2008, above 24ng/mL; Blood folate, 02Apr2009, 5.7; Blood iron, 11Mar2009, 206mcg/dL; Blood iron, 03Apr2009, 183; Blood parathyroid hormone, 24Oct2008, 215; Blood parathyroid hormone, 05Nov2008, 202pg/mL; Blood parathyroid hormone, 11Mar2009, 748.9pg/mL; Blood phosphorus, 24Oct2008, 5.8; Blood phosphorus, 03Apr2009, 6; Blood potassium, 24Oct2008, 5.2; Blood potassium, 01Apr2009, 3.2; Blood thyroid stimulating horm, 02Apr2009, 22; Blood urea, 24Oct2008, 66; Blood urea, 05Nov2008, 72mg/dL; Blood urea, 06Feb2009, 36; Blood urea, 11Mar2009, 36mg/dL; Blood urea, 11Mar2009, 83%; Blood urea, 03Apr2009, 33; Body temperature, 30Mar2009, 99.9F; Carbon dioxide, 24Oct2008, 18; Carbon dioxide, 01Apr2009, 32; Carbon dioxide, 02Apr2009, 33; Cytomegalovirus test, 03Apr2009, negative; Glomerular filtration rate, 06Feb2009, 9; Glomerular filtration rate, 01Apr2009, 24.2; Glomerular filtration rate, 03Apr2009, 8.3; Glomerular filtration rate, 04Apr2009, 11.7; Glomerular filtration rate, 02Jul2009, 15; HIV test, 03Apr2009, negative; Hemoglobin, 24Oct2008, 11.3; Hemoglobin, 27Oct2008, 11.3; Hemoglobin, 05Nov2008, 10.1g/dL; Hemoglobin, 07Nov2008, 10.1; Hemoglobin, 19Nov2008, 10.5; Hemoglobin, 03Dec2008, 12.2; Hemoglobin, 21Jan2009, 14.7; Hemoglobin, 06Feb2009, 16.8; Hemoglobin, 25Feb2009, 12; Hemoglobin, 04Mar2009, 10.7; Hemoglobin, 11Mar2009, 10.0; Hemoglobin, 25Mar2009, 6.7; Hemoglobin, 30Mar2009, 5.6; Hemoglobin, 01Apr2009, 6; Hemoglobin, 02Apr2009, 6; Hemoglobin, 03Apr2009, 5.5; Hemoglobin, 04Apr2009, 8.5; Hemoglobin, 05Apr2009, 8.4; Hemoglobin, 06Apr2009, 8; Hemoglobin, 15Apr2009, 6.8; Hemoglobin, 22Apr2009, 8.7; Hemoglobin, 29Apr2009, 7.4; Hemoglobin, 06May2009, 6.1; Hemoglobin, 08May2009, 10.5; Hepatitis B antigen, 24Oct2008, negative; Hepatitis B antigen, 11Mar2009, negative; Hepatitis B core antigen, 03Apr2009, negative; Hepatitis B surface antigen, 03Apr2009, negative; Hepatitis C antibody, 03Apr2009, negative; Hepatitis C virus test, 05Nov2008, negative; Iron binding capacity unsatura, 11Mar2009, 42mcg/dL; Neutrophil count, 01Apr2009, 1.2; Neutrophil count, 02Apr2009, 1.3; Occult blood, 01Apr2009, x1 negative; Occult blood, 04Apr2009, negative; Parvovirus B19 serology, 02Apr2009, negative; Platelet count, 24Oct2008, 3.75; Platelet count, 05Nov2008, 443x1000/mcL; Platelet count, 06Feb2009, 232000; Platelet count, 11Mar2009, 256; Platelet count, 02Apr2009, 242000; Platelet count, 03Apr2009, 241; Platelet count, 04Apr2009, 228; Platelet count, 05Apr2009, 214; Platelet count, 08May2009, 266; Protein total, 02Apr2009, 6.3; Protein total, 03Apr2009, 6.5; Serum ferritin, 11Mar2009, 810ng/mL; Serum ferritin, 03Apr2009, 630; Total iron binding capacity, 03Apr2009, 196; Transferrin, 03Apr2009, 140; Transferring saturation, 05Nov2008, 11%; Transferring saturation, 11Mar2009, 83%; Transferring saturation, 03Apr2009, 93; Urine culture, 01Apr2009, no bacteria; Vitamin B12, 02Apr2009, 1051; Vitamin B12, 02Jul2009, 1051; White blood cell count, 05Nov2008, 11.95x1000/mcL; White blood cell count, 06Feb2009, 10800; White blood cell count, 11Mar2009, 4.14x1000;mcL; White blood cell count, 01Apr2009, 2800; White blood cell count, 02Apr2009, 2400; White blood cell count, 03Apr2009, 2.7; White blood cell count, 04Apr2009, 3.5; White blood cell count, 05Apr2009, 4.2; White blood cell count, 08May2009, 5.1; 06 February 2009: Computerised tomogram abdomen: results revealed focal fatty infiltrate within the liver adjacent to the falciform ligament and severely atrophic & cystic kidneys. A left ovarian cyst and congenital deformity at the lumbosacral spine with dysgraphism were noted as well. The lung bases were clear. No acute intra-abdominal abnormality was identified. Imaging procedure: showed focal fatty infiltration noted within the liver. Kidneys were atrophic and cystic. 01 April 2009: Blood smear test: showed predominantly normochromic normocytic erythrocytes with rare target cells. No increased polychromasia, nucleated blood cells, erythrocyte fragments and microspherocytoses were observed. The white blood cells were decreased with no early white blood cell forms detected, the neutrophils did not have increased granulation or vacuoles: no giant platelets were identified. Urine analysis: revealed small blood, positive protein, positive leukocyte esterase, five to ten white blood cells and few bacteria. 02 April 2009: Blood smear test: showed significant artifact, and no increased red blood cell fragments were identified. 03 April 2009: Computerised tomogram chest: showed a duplicated left superior vena cava extending along the left mediastinum to the left heart border, 8 mm hypodense lesion of left thyroid, constipation and athrophic kidneys consistent with end-stage renal disease; no pleural effusion, gross mediastinal or hilar adenopathy were detected; lungs were clear with no pneumothorax. No findings to explain the patient's shortness of breath were identified. Electrophoresis protein: revealed no monoclonal proteins and decreased IgG and IgA components. 04 April 2009: Urine electrophoresis: showed a polyclonal increased in free Kappa and/or free lambda light chains; no monoclonal free light chains were identified. 23 April 2009: Aspiration bone marrow: clot sections and core biopsy revealed normocellular (60-70 percent) bone marrow with trilineage hematopoiesis, left shifted granulopoiesis, marked erythroid hyperplasia and mild megakaryocytic hyperplasia; increased storage iron; mild paratrabecular reticulin fibrosis, 1+/4+; no atypical non hematopoietic cells or granulomas were identified; scattered erythroid and myeloid precursors are present. Blood smear test: Peripheral blood smear revealed anemia and leukopenia. Flow cytometry: analysis showed no significant immunophenotypic abnormalities.	OTH	OTH	Paricalcitol; Calcium acetate; Prednisone; Amlodipine; Heparin; Cyclosporin; Dextriferron; Calcitriol; Sodium bicarbonate; Zolpidem tartrate; Laxative; Mycophenolate mofetil	Alcohol use; Arteriovenous fistula; Bone metabolism disorder; Chronic allograft nephropathy; Congenital anomalies of spine; Congenital renal dysplasia NOS; Dry skin; End stage renal disease; Hemodialysis; High blood pressure; Hyperparathyroidism; Hyperphosphatemia; Jugular catheterization; Metabolic acidosis; Ovarian cyst; Pneumothorax; Short stature; Vascular injury	Biopsy kidney; Central line placement; Chest tube insertion; Kidney transplant		A0801390A	1						1	Abdominal pain; Acidosis; Alopecia; Anaemia; Aspiration bone marrow abnormal; Asthenia; Atrophy; Biopsy bone marrow abnormal; Blood albumin normal; Blood bicarbonate decreased; Blood chloride decreased; Blood creatinine increased; Blood erythropoietin increased; Blood folate increased; Blood iron increased; Blood parathyroid hormone increased; Blood phosphorus increased; Blood potassium increased; Blood smear test abnormal; Blood thyroid stimulating hormone increased; Blood urea increased; Body temperature increased; Bone marrow failure; Carbon dioxide decreased; Computerised tomogram abdomen abnormal; Computerised tomogram head; Computerised tomogram thorax abnormal; Congenital cystic kidney disease; Constipation; Culture urine negative; Cytomegalovirus test negative; Deformity; Diarrhoea; Dysgraphia; Dyspnoea; Dyspnoea exertional; Electrophoresis protein abnormal; Fatigue; Fibrosis; Flow cytometry; Gastrointestinal disorder; Glomerular filtration rate abnormal; Granulocytopenia; HIV test negative; Haemodialysis; Haemoglobin decreased; Hepatic steatosis; Hepatitis B antigen; Hepatitis B core antigen; Hepatitis B e antigen negative; Hepatitis B surface antigen negative; Hepatitis C antibody negative; Hepatitis C virus test; Hilar lymphadenopathy; Hyperkalaemia; Hyperphosphataemia; Immunosuppression; Iron binding capacity total decreased; Iron binding capacity unsaturated decreased; Leukopenia; Light chain analysis increased; Lymphadenopathy mediastinal; Marrow hyperplasia; Myelodysplastic syndrome; Neutrophil count decreased; No therapeutic response; Normochromic normocytic anaemia; Occult blood negative; Oedema peripheral; Ovarian cyst; Parvovirus B19 serology negative; Persistent left superior vena cava; Platelet count increased; Protein total decreased; Pulmonary function test normal; Pyrexia; Rash erythematous; Renal atrophy; Renal failure chronic; Renal impairment; Serum ferritin increased; Spine malformation; Thyroid disorder; Transferrin decreased; Transferrin saturation decreased; Transfusion; Transplant rejection; Urine analysis abnormal; Urine electrophoresis abnormal; Vitamin B12 increased; White blood cell count decreased; White blood cell count increased	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0324631	08/13/2009	CA	5.0	5		F	11/21/2008	A non-serious report of expired dose of vaccine administered was received from a physician concerning a five-year-old female.  No medical history or concomitant medications were reported.  The patient received FLUMIST vaccine on 05-Feb-2008.  The FLUMIST vaccine administered had an expiration date of 31-Dec-2007.  Follow-up call to the reporter after four weeks on 04-Mar-2008 confirmed that the patient did not experience any adverse events after receiving expired FLUMIST vaccine.  The patient did not experience a rechallenge while receiving the suspect product.  The reporter did not provide a statement of causality.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  Additional information received on 04-Mar-2008  :  reporter confirmed patient did not experience adverse events.  Additional information received on 21-Nov-2008 :  patient's date of birth and lot number.									Y	02/05/2008	02/05/2008	0		PVT	OTH	Concomitant Drug (s) Not Reported.				MEDI0006522	1						2	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500490P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0328370	08/13/2009	IL	12.0			M	10/22/2008	A non-serious spontaneous report of dizziness, nausea, and emesis has been received from a nurse concerning a 12-year-old male, subsequent to FLUMIST.  No relevant medical and/or drug history information has been reported for this patient.  Concomitant vaccines included Hepatitis A, MENACTRA, and Tdap, which were all given on the same day as FLUMIST.  The patient received FLUMIST on 13-Oct-2008.  After receiving the vaccines followed by a lead test, the patient complained of being dizzy, lightheaded, nauseated and  he vomited once.  The patient was placed in a lying position, with his feet elevated, and given cold water to drink. The patient's blood pressure was fine.  Thirty to 45 minutes later, the events resolved and the patient left the clinic with his mother.									Y	10/13/2008	10/13/2008	0		PVT	OTH	Not Reported				MEDI0007315	1						5	Dizziness; Heart rate normal; Nausea; Oxygen saturation normal; Vomiting; Dizziness; Heart rate normal; Nausea; Oxygen saturation normal; Vomiting; Dizziness; Nausea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500545P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2|MNQ~SANOFI PASTEUR~U2618AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TDAP~SANOFI PASTEUR~C2767AA~UNK~IM~RA~TDAP (ADACEL)~2|VARCEL~MERCK & CO. INC.~1140X~2~SC~RA~VARICELLA (VARIVAX)~2|FLUN3~MEDIMMUNE VACCINES, INC.~500545P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3|MNQ~SANOFI PASTEUR~U2618A~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~3|TDAP~SANOFI PASTEUR~C2767A~1~IM~RA~TDAP (ADACEL)~3|VARCEL~MERCK & CO. INC.~1140X~2~SC~UN~VARICELLA (VARIVAX)~3|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~5|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~5|MNQ~SANOFI PASTEUR~~UNK~UN~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~5|TDAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~TDAP (NO BRAND NAME)~5	USA		Influenza
0335216	08/13/2009	TX	14.0			F	12/12/2008	A spontaneous non-serious report of administration to pregnant female, fever and stomach ache has been received from a nurse concerning a 14 year old female patient subsequent to FLUMIST. Medical history included psychiatric disorder. Concomitant medications included psychiatric medications (no specific medications provided), Tdap, MCV and HPV vaccines. On 05-Dec-2008, the patient received FLUMIST. The school nurse administered FLUMIST concomitantly with Tdap, MCV and HPV vaccinations. The patient reported to the nurse that her last menstrual period was less that one month prior to receiving the vaccinations. On 10-Dec-2008, the patient presented to the emergency room (ER) with fever and a stomach ache. Laboratory tests included a urine pregnancy test which was positive. The patient was to visit an obstetrician on 22-Dec-2008; she plans to maintain the pregnancy. After returning to school, the patient was transferred to a different school. At the time of the report, the outcome for the events of administered to a pregnant female, fever and stomach ache was unknown.									U	12/05/2008	12/10/2008	5	Urine Pregnant Test, 12/10/08, positive	OTH	OTH	Concomitant Drug(s) Not Reported		Past Disease: Psychiatric disorder NOS		MEDI0007628	1						3	Abdominal pain upper; Drug exposure during pregnancy; Nausea; Pregnancy test positive; Pyrexia; Vomiting; Abdominal pain upper; Drug exposure during pregnancy; Pregnancy test positive; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~2|HPV4~MERCK & CO. INC.~0381X~UNK~UN~UN~HPV (GARDASIL)~2|MNQ~SANOFI PASTEUR~U2683A~UNK~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~2|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B030AA~UNK~UN~UN~TDAP (BOOSTRIX)~2|FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~3	USA		Influenza
0337608	08/13/2009	DC	5.0	5		F	04/09/2009	Expired vaccine used (expired drug administered). A non-serious, spontaneous report of administration of expired product was received from a nurse. There was no adverse event associated with this medication error; therefore treatment and reporter / sponsor causality assessment are not applicable and the event is considered resolved. Based on the results of the investigation the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 09-Apr-2009: Product complaint investigation results.									Y	12/22/2008	12/22/2008	0		PVT	OTH	Not reported				MEDI0007748	1						2	Expired drug administered; No adverse event; Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500548P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500548P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0355011	08/13/2009	MN	9.0	9		M	10/29/2008	A serious labeled spontaneous report of fever, headache and non-serious body aches, cough and vomiting has been received from a nurse for a nine-year-old male. The events occurred one day after the patient received FLUMIST. The patient is a normal, healthy boy with no history of allergies and he is not taking any concomitant medications. The patient received FLUMIST on 25-Oct-2008 nasally for influenza prophylaxis. The day after receiving FLUMIST he experienced fever, cough, headache, vomiting and body aches. On 27-Oct-2008, he visited the clinic and had a high temp of 102.9, he was treated with acetaminophen and ibuprofen. On 28-Oct-2008, he did not improve and was hospitalized due to the high fever and headache. His WBC was elevated to 24,000 and a blood culture was negative. He was treated with intravenous fluids. After treatment, the events resolved and the patient was discharged in good condition on 29-Oct-2008.					Y	1			Y	10/25/2008	10/26/2008	1	Blood cultures, 10/28/08, negative;  White blood cell count, 10/28/08, 24,000	PVT	OTH	Concomitant Drug(s) Not Reported		No allergies; No prior medical history		MEDI0007353	1						1	Blood culture negative; Cough; Headache; Pain; Pyrexia; Vomiting; White blood cell count increased	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0355105	08/13/2009	KY	14.0			F	08/11/2008	A non-serious spontaneous report of stuffy nose, headache, sneezing, and malaise has been received from a consumer, concerning a 14-year-old female subsequent to FLUMIST.  Neither relevant medical history nor concomitant medications have been reported for this patient.  The patient received FLUMIST on 08-AUG-2008.  The day after receiving FLUMIST, the patient developed stuffy nose, headache, sneezing, and malaise.  At the time of the report, the patient was feeling better.  The outcome has not been reported.									U	08/08/2008	08/09/2008	1		OTH	OTH	Concomitant Drug (s) Not Reported.				MEDI0007064	1						1	Headache; Malaise; Nasal congestion; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355106	08/13/2009	MI	31.0	31		F	08/20/2008	A non-serious spontaneous report of accidental exposure while administering drug and asthma attack has been received from a nurse concerning a 31-year-old female, subsequent to administering FLUMIST to patients in a physician's office.  Neither relevant medical history nor concomitant medications have been reported for this patient.  The patient administered FLUMIST to two patients in a physicians office.  Immediately after administering FLUMIST to the two patients, the patient (a health care worker) experienced an asthma attack.  The patient self-administered a nebulizer treatment and experienced relief.									U	08/20/2008	08/20/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported.				MEDI0007079	1						1	Accidental exposure; Asthma	FLUN3~MEDIMMUNE VACCINES, INC.~500543P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355107	08/13/2009	PA	7.0	7		M	08/21/2008	A non-serious spontaneous report of NOSE BLEED was received from a physician concerning a seven-year-old male subsequent to FLUMIST.  The patient's medical history has not been reported.  The patient was also taking SINGULAIR.  The patient received FLUMIST vaccine on 12-Aug-2008.  On 17-Aug-2008, the patient started having nose bleeds which continued over four days.  The patient's parent indicated that there was a total of ten nose bleeding episodes during that period of time.  The outcome of the event is unknown.									U	08/12/2008	08/17/2008	5		OTH	OTH	Not Reported				MEDI0007080	1						1	Epistaxis	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355108	08/13/2009					U	08/22/2008	A non-serious spontaneous report of shaking, nasal passage irritation, sweating, chills, headache, and nausea has been received from a consumer concerning a patient of unknown age subsequent to FLUMIST.  The patient's past medical history includes mild anemia.  The patient received FLUMIST on 22-Aug-2008 at 0920.  The patient experienced shaking, chills, sweating (enough to create six inch by three inch large pit stain under her arms), headache (that lasted all day), nasal passage irritation, and intermittent nausea on the same day that FLUMIST was received.  The outcome was not reported.									U	08/22/2008	08/22/2008	0		OTH	OTH	Not reported				MEDI0007031	1						1	Chills; Headache; Hyperhidrosis; Nasal discomfort; Nausea; Tremor	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355114	08/13/2009	TX	13.0			M	08/22/2008	A non-serious spontaneous report of GENERLIZED RASH as been received from a nurse concerning a 13-year-old male subsequent to FLUMIST. Neither medical history nor concomitant medications have been reported. The patient received FLUMIST vaccine on 21-Aug-2008. Two and a half hours after receiving FLUMIST vaccine, the patient developed rash described as covering the entire body except the hands and soles of the feet. The rash was aggravated by heat and is relieved by BENADRYL. At the time of the report, the event has not resolved and the rash was reported to be still waxing and waning.									N	08/21/2008	08/21/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007082	1						1	Rash generalised	FLUN3~MEDIMMUNE VACCINES, INC.~500543P~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355115	08/13/2009	OH	42.0	42		M	09/03/2008	A non-serious spontaneous report of shaking, fever, muscular chest and back pain, chills, headache, cough and fatigue has been received from a consumer (male, in his late 30's), who happens to be a physician, subsequent to FLUMIST.  The patient stated that he already had a cold prior to FLUMIST administration.  No concomitant medications have been reported for this patient.  The patient received FLUMIST on 02-Sep-2008 at 2pm.  This was the patient's first dose of FLUMIST.  By 6pm on the same date, the patient started experiencing symptoms of muscular chest and back pain, fever, fatigue, shaking, chills and headache.  By 12 midnight on the same date, the symptoms continued and were reportedly worse.  The patient also had a cough by this time.  The symptoms continued through the day of 03-Sep-2008 and started resolving by the evening.  The outcome of the events is resolved.  The patient has fully recovered on 04-Sep-2008.  The reporter was unsure of the relationship of the adverse events to FLUMIST therapy.  Additional information was obtained on 23-Sep-2008 and incorporated into the narrative:  data and time of FLUMIST administration, event description, information that patient had a cold the same time as the occurrence of adverse events, and adverse events onset and cessation dates.									Y	09/02/2008	09/02/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported.	Cold			MEDI0007098	1						1	Back pain; Chills; Cough; Fatigue; Headache; Myalgia; Non-cardiac chest pain; Pyrexia; Tremor	FLUN3~MEDIMMUNE VACCINES, INC.~500544P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355116	08/13/2009	NY	52.0			M	09/29/2008	A non-serious spontaneous report of FLUMIST inadvertently given to a 52-year old male was received from a pharmacist.  The patient's medical history was not reported.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	09/29/2008	09/29/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported.				MEDI0007160	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500551P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355117	08/13/2009	MD	27.0	27		F	09/30/2008	A non-serious spontaneous report of viral syndrome, flu symptoms, gastroenteritis, myalgias, and neck pain has been received from a nurse in a physician's assistant office and the patient, a 27-year-old female. Concomitant medications included lamotrigine, buspirone hydrochloride, venlafaxine, and duloxetine hydrochloride.  The patient had an allergy to aspirin. The patient received FLUMIST, intranasal administration for flu immunization on 19-AUG-2008. The patient had never received FLUMIST before. Since receiving FLUMIST, the patient was having viral syndrome that started to improve. On 26-Aug-2008, the patient thought she may have had gastroenteritis or food poisoning. She developed severe diarrhea. The patient also reported her experience as flu symptoms described as headache, fever, chills, sever aches, and dehydration. She had no abdominal pain, nausea or vomiting, just decreased appetite. She had no blood or mucous in her stools. On 27-Aug-2008, the patient experienced myalgias and neck pain (reported by the patient as a neck strain that stretched from the back of the lower neck over the head and to the eyes). The patient saw her physician's assistant on 28-Aug-2008 and was diagnosed with gastroenteritis with viral syndrome, currently improving. The patient reported her diagnosis as a virus that attacks the neck muscles. The PA recommended pushing plenty of fluids and gastrointestinal rest. The patient recovered from the events of Viral syndrome, gastroenteritis, flu symptoms, myalgias, and neck pain. The PA's nurse did not feel the patient's illness was secondary to FLUMIST.									Y	08/19/2008	08/26/2008	7		OTH	OTH	LAMICTAL; BUSPAR; EFFEXOR; CYMBALTA		Allergy to aspirin		MEDI0007111	1						1	Chills; Decreased appetite; Dehydration; Diarrhoea; Gastroenteritis; Headache; Influenza; Myalgia; Neck pain; Pain; Pyrexia; Viral infection	FLUN3~MEDIMMUNE VACCINES, INC.~500541P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355118	08/13/2009	MO	7.0			M	03/24/2009	A non-serious spontaneous report of expired FLUMIST inadvertently administered was received from a registered nurse concerning a seven-year-old male. Neither medical history nor concomitant medications were provided. The patient received his first dose of FLUMIST on 11-Sep-2008. The FLUMIST had expired on 03-Apr-2008. The reporter stated that FLUMIST was given by one of the nurses helping out the clinic on 11-Sep-2008 and not by the nurse in-charge of immunizations. The incident regarding the expired FLUMIST was noted when the immunization record was being updated. As of 24-Sep-2008, there was no adverse event reported; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Mar-2009: Product Complaint Investigative results. Based on the results of the investigation, the root cause for the medication error were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.									Y	09/11/2008	09/11/2008	0		PUB	OTH	Concomitant Drug (s) Not Reported				MEDI0007118	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500500P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355119	08/13/2009	FL	6.0			F	09/11/2008	A non-serious spontaneous report of pneumonia, sleeping a lot, fever, asthma and coughing was received from a mother concerning a six year-old female subsequent to FLUMIST. Medical history included asthma. No concomitant medications were reported for this patient. The patient received FLUMIST in the last week of August 2008. The patient developed a high fever (104 degrees Fahrenheit) 12 hours after receiving FLUMIST. The patient was taken to the emergency room and treated for pneumonia and an asthma attack. The patient was not hospitalized. Subsequently in September 2008, the patient had symptoms of coughing and sleeping a lot. The outcome of the adverse events was not reported. Additional dosing with FLUMIST was not reported. No causality assessment was reported.									U	08/01/2008	08/01/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported	Asthma ( 10003553)			MEDI0007120	1						1	Asthma; Cough; Hypersomnia; Pneumonia; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355120	08/13/2009	MN	5.0			F	09/19/2008	A Non - serious spontaneous report of administered two doses of vaccine in two day period has been received from a nurse concerning a 5-year old female patient.  No medical or medication history were reported for this patient.  The patient received FLUMIST intranasally in one office on 27AUG2008 and received another dose at a different office by the same physician on 29Aug2008.  The patient received FLUMIST for flu prevention.  The office were reportedly not computerized and the second office did not have the patient's chart.  The physician's office confirmed that there were no adverse events associated with this medication error; therefore, treatment and reporter/ sponsor causality assessments are not applicable, and the event is considered resolved.  Additional information was obtained on 19Sep2008 and incorporated into the narrative:  confirmation from the physician's office that no adverse events occurred from the medication error.									Y	08/27/2008	08/29/2008	2		PVT	OTH	Concomitant Drug (s) Not Reported.				MEDI0007121	1						1	Incorrect dose administered; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355121	08/13/2009	VA	12.0			M	09/25/2008	A non-serious spontaneous case of inadvertent administration of FLUMIST to an asthmatic and cough has been received from a nurse in a 12-year-old male, subsequent to receiving FLUMIST.  The reporting nurse stated the patient was inadvertently administered FLUMIST.  The patient returned to see the physician on 15-Sep-2008 for a cough; at that time there was no wheezing, some rhonchi and other family members had upper respiratory symptoms.  The patient was treated with PREDNISONE and ZITHROMYCIN.  The patient was rechecked on 17-Sep-2008 at which time his lungs were clear and the cough had resolved.  All events resolved.									Y	09/11/2008	09/11/2008	0		PVT	PVT	Concomitant Drug (s) Not Reported	Asthma			MEDI0007124	1						1	Contraindication to vaccination; Cough; Rhonchi; Sick relative	FLUN3~MEDIMMUNE VACCINES, INC.~500544P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355122	08/13/2009	MD	40.0	40		M	09/17/2008	A non-serous spontaneous report of headache, nausea, vomiting, and diarrhea has been received from a consumer concerning a 40-year old male subsequent to FLUMIST. No medical or medication history was provided for this patient. The patient received FLUMIST on 13-Sep-2008. The patient started having slight symptoms on 15-Sep and 16-Sep-2008. The patient was reportedly bending over by 17-Sep-2008. The patient was not seen by a physician for treatment. The patient did not receive treatment for the adverse events but had lots of rest. The patient recovered from the adverse events on 17-Sep-2008. The reporter assessed the relationship of the adverse events to FLUMIST as not sure, but we think so.									Y	09/13/2008	09/15/2008	2		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007139	1						1	Diarrhoea; Headache; Nausea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355123	08/13/2009	MD	5.0	5		M	09/17/2008	A non-serious spontaneous report of headache, nausea, vomiting, and diarrhea has been received from a consumer concerning a five-year old male subsequent to FLUMIST.  No medical or medication history was provided for this patient.  The patient received FLUMIST on 13-Sep-2008.  The patient's symptoms started on 13-Sep-2008.  The symptoms were reportedly worse on 14-Sep-2008 and better on 15-Sep-2008.  The patient was not seen by a physician for treatment.  The patient did not receive treatment for the adverse events but had lots of rest.  The patient recovered from the adverse events on 15-Sep-2008.  The reporter assessed the relationship of the adverse events of headache, nausea and vomiting to FLUMIST as not sure, but we think so.									Y	09/13/2008	09/13/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007141	1						1	Diarrhoea; Headache; Nausea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355124	08/13/2009	KY	31.0			F	09/19/2008	A non-serious spontaneous report of rash and whelps was received from an office manager of a doctor's clinic concerning a 31-year-old female health care worker after receiving FLUMIST.  The patient has no known allergies to food including eggs or other medication.  She is not taking any concomitant medications.  The patient received FLUMIST intranasally on 17-Sep-2008.  Upon awakening on 19-Sep-2008, the patient noted rash and whelps over her entire body and inside her mouth.  On the same day, she consulted with her health care provider.  She was given an unknown steroid injection in the clinic and prescribed unknown steroid to be taken orally.  The patient's rash and whelps resolved on 21-Sep-2008.									Y	09/17/2008	09/19/2008	2		OTH	OTH	Concomitant Drug (s) Not Reported		The patient has no known allergies to food including eggs, or other medications;		MEDI0007144	1						1	Oral mucosal eruption; Rash generalised; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355125	08/13/2009	MN	5.0	5		F	09/30/2008	A non-serious spontaneous report of swelling under left eye, flat red itchy rash, and hives has been received from a nurse and a physician concerning a five-year-old female subsequent to FLUMIST. Medical history included Down's syndrome, trigonocephaly, hypothyroidism, and alopecia. The patient had no known allergies. On 19-Sep-2008, the patient received FLUMIST for flu immunization. The patient also received DTaP, IPV, MMR, and VARICELLA vaccines on the same day. About 40-45 minutes after receiving FLUMIST on 19-Sep-2008, the patient developed swelling under the left eye (1/4 size of an egg) and a flat red itchy rash that disseminated throughout her body. She developed hives on the back of her neck, one on her trunk, and one behind her left ear. The patient's mother brought her back to the physician's office. She had no difficulty breathing and no distress. The patient was treated with oral diphenhydramine in the office 40 minutes after the events started and the swelling and rash improved. The hives disappeared within a few hours and the patient had no other problems. The physician spoke to the patient's mother who indicated the patient has been fine since the events. The nurse indicated the physician thought the events were caused by FLUMIST because it was the only vaccine the patient had never had before. Additional information was received from the physician on 30-Sep-2008 and incorporated into the above narrative which included the outcome of the events.									Y	09/19/2008	09/19/2008	0		PVT	OTH	Concomitant Drug (s) Not Required	Down's syndrome (10013616), Hypothyroidism (10021114), Alopecia (10001760)	Trigonocephaly		MEDI0007146	1						1	Rash pruritic; Swelling face; Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B045BA~5~IM~UN~DTAP (INFANRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500540P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~A0805~4~IM~UN~POLIO VIRUS, INACT. (POLIOVAX)~1|MMR~MERCK & CO. INC.~0907X~2~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0907X~2~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0355126	08/13/2009	NY	11.0			M	09/24/2008	A non-serious spontaneous report of wheezing was received from a physician concerning an 11-year-old male subsequent to FLUMIST. The patient has no history of asthma, wheezing, or allergies. No concomitant medications were reported. The patient received FLUMIST on 24-Sep-2008. Fifteen minutes after receiving FLUMIST, the patient started wheezing. The symptoms required treatment with nebulized albuterol. The wheezing improved but still ongoing as of 24-Sep-2008.									U	09/24/2008	09/24/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported		The patient has no history of asthma, wheezing, or allergies;		MEDI0007152	1						1	Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355127	08/13/2009	IL	5.0			F	09/25/2008	A non-serious spontaneous report of nose bleed was received by an employee in a pediatric office, concerning a five-year old female subsequent to FLUMIST. Neither medical history nor concomitant medications have been reported. The patient received FLUMIST on an unreported date. Immediately after FLUMIST administration, the patient developed nose bleed in one nostril. The bleeding was easily controlled and stopped before the patient left the pediatrician's office.									Y					UNK	UNK	Concomitant Drug(s) Not Reported		Medical history not reported		MEDI0007158	1						1	Epistaxis; Immediate post-injection reaction	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355129	08/13/2009	FL	5.0			M	09/26/2008	A non-serious spontaneous report of swelling of right lower eyelid was received from a father concerning his 5-year-old male child subsequent to FLUMIST. The patient has no egg or milk protein allergy nor asthma. Concomitant medications were not reported for this patient. The patient had previously received 3 doses of flu vaccine with no reported adverse events. The patient received FLUMIST by nasal administration for the first time on 23-Sep-2008. On 24-Sep-2008, a reaction occurred under the patient's eye described as swelling of the right lower eyelid. As of 03-Oct-2008, the clinic where the patient received FLUMIST has not received any communication regarding the adverse event nor was the patient brought in for follow-up consultation. The right lower eyelid was still swollen as of 26-Sep-2008.									N	09/23/2008	09/24/2008	1		OTH	OTH	Concomitant Drug(s) Not Reported		The patient has no egg or milk protein allergy nor asthma; He had previously received 3 doses of Flu vaccine with no reported adverse events;		MEDI0007159	1						1	Eyelid oedema; No reaction on previous exposure to drug	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355151	08/13/2009		9.0			M	09/29/2008	A non-serious report of administration of FLUMIST to a nine-year-old male on daily ASPIRIN was received from a consumer. The patient's medical history was not provided. His only concomitant medication is daily ASPIRIN taken orally. The patient received FLUMIST via nasal administration for the first time on 26-Sep-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event in considered resolved.									Y	09/26/2008	09/26/2008	0		OTH	OTH	ASPIRIN		Medical history not reported.		MEDI0007161	1						1	No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355152	08/13/2009	TX	8.0	8		F	09/29/2008	A non-serious, spontaneous report of aching, hot then cold, headache, nausea, sinus infection and stomachache was received from a consumer concerning a eight-year old female patient, subsequent to FLUMIST.  Consumer indicated there is no medical history and no concomitant medications.  The patient received FLUMIST on Wednesday, 24-Sep-2008.  Approximately two hours after dosing the patient experienced aching and headache.  The following morning the patient was seen in the doctors office and diagnosed with a sinus infection.  Later the same day the symptoms were reported as worse and the patient was prescribed CODEINE/acetaminophen, which barely took the headaches and aching away.  On Friday, 26-Sep-2008 the patient cried for hours and experienced stomachache, nausea and reported feeling hot then cold.  The patient was taken to the emergency room and the physician diagnosed her with having adverse side effects from FLUMIST and prescribed HYDROCODONE/acetaminophen just numbed the pain but did not make it go away.  The patient was taken back to the emergency room at a different hospital and blood work and a contrast MRI of the head to the abdomen were collected.  All results were normal and he said it must be some adverse reaction to FLUMIST.  The consumer stated she does not think the patient has a sinus infection.  Events of aching, hot then cold, headache, nausea and stomach ache are ongoing as of 03-Oct-2008.  The outcome of the event of sinus infection is unknown.  The reporter assessed the events as possibly related to FLUMIST. Required follow-up attempts have been performed, requested information unable to be obtained.									Y	09/24/2008	09/24/2008	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0007164	1						1	Abdominal pain upper; Feeling of body temperature change; Headache; Laboratory test; Nausea; Nuclear magnetic resonance imaging abnormal; Pain; Sinusitis	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355153	08/13/2009	PA	9.0			M	11/06/2008	A serious report of vomiting, diarrhea, and abdominal pain has been received from a physician and a consumer (patient's mother) concerning a nine-year-old male subsequent to FLUMIST. Concomitant medications included dexmethylphenidate hydrochloride for attention deficit disorder. The patient had a history of constipation. The patient was an otherwise healthy child and had no known allergies to food or medications. The patient received FLUMIST on 08-Sep-2008 for health maintenance. On 09-Sep-2008, the patient experienced vomiting, diarrhea, and abdominal pain. His symptoms were intermittent. The second episode occurred when he awoke on 13-Sep-2008 and the patient went to the physician's office. The patient's symptoms continued at least daily to every other day. He went to the doctor twice for treatment. An abdominal X-ray was normal. The physician reported stool testing was ordered but no results were available and questioned if the patient did not go for the testing. On 17-Oct-2008, the patient had another episode of vomiting, diarrhea, and abdominal pain. Three or four days after that, the patient had another episode of vomiting, diarrhea, and abdominal pain. Both times the patient had eaten something that had egg proteins in it like a muffin during the day and experienced the episodes in the middle of that night. The patient did not have an egg allergy. In between episodes, the patient was fine. On 05-Nov-2008, the patient was seen by a general pediatrician in a different medical center. The pediatrician did not perform any testing because he indicated that patient previously had a normal abdominal X-ray. He also reported that the patient had a history of constipation and thought his symptoms might be related to constipation. As of 05-Nov-2008 when he saw the general pediatrician, the patient's episodes were occurring far less frequently. The physician indicated the vomiting, diarrhea, and abdominal pain were considered serious (important medical event) due to frequent school absences. Additional information received on 14-Oct-2008 from the physician was incorporated into the above narrative and included serious criteria, event outcome, additional patient information, indication and lot number for FLUMIST, concomitant therapy and medical history. Additional information received on 27-Oct-2008 the patient's mother was incorporated into the above narrative and included event outcome and details on additional episodes of the events. Additional information received on 06-Nov-2008 from a general pediatrician was incorporated into the above narrative and included additional details regarding the event.				Y					U	09/08/2008	09/09/2008	1	Abdominal X-ray, ??/??/08, normal; Stool analysis, ??/??/08	PVT	PVT	FOCALIN XR	ADD; 2) Constipation			MEDI0007168	1						1	Abdominal X-ray; Abdominal pain; Diarrhoea; Stool analysis; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500544P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0355154	08/13/2009	IL	5.0	5		M	01/12/2009	A non-serious unlabeled spontaneous case of impetigo with redness and irritation under the nose has been received from a physician for a five-year old male, subsequent to receiving FLUMIST. The patient received one dose of FLUMIST nasally for flu vaccination on 26-Sep-2008. The reporting physician stated the patient developed irritation and redness under his nose several hours after FLUMIST administration. The patient went to his primary care physician on 02-Oct-2008 with a crusting red area under his nose that appears to be impetigo. The patient was treated with MUPIROCIN CALCIUM and CEFALEXIN. The events were considered resolved on 09-Jan-2009. The reporting physician indicated he is doubtful if FLUMIST caused the impetigo. Follow up received on the 21-Oct-2008 includes treatment for the impetigo and no outcome for the event. Follow up received on 12-Jan-2009 includes outcome of the events, patient's name and date of birth. Follow up received on 16-Jan-2009 includes general vaccine information and patient's address and county of the physician's office. The reporter also confirmed the information received on 12-Jan-2009.									Y	09/26/2008	09/26/2008	0		PVT	PVT	Concomitant Drug(s) Not Reported				MEDI0007176	1						1	Erythema; Impetigo; Scab; Skin irritation	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355155	08/13/2009	MI				F	10/03/2008	A non-serious spontaneous report of accidental exposure and headache has been received from a female medical assistant (date of birth 01-May-1969) concerning her own experience subsequent to administering FLUMIST.  Medical history included migraines.  Concomitant medications included levothyroxine, duloxetine hydrochloride, cetirizine hydrochloride, and montelukast sodium.  The patient did not take medication for her migraines.  The medical assistant never received FLUMIST.  When the medical assistant administers FLUMIST to a patient or walks into an exam room where FLUMIST was administered, she develops a headache across the top of her forehead.  She described them as mild, they are not migraines, and the headache last until she goes outside away from where FLUMIST is being administered.  She indicated that it did not matter if she administered FLUMIST first thing in the morning or not until the middle of the afternoon, she always got a headache from it.  She experienced no other symptoms.  The medical assistant did not treat the headaches because they always resolved as soon as she went outside. Required follow-up attempts have been performed, requested information unable to be obtained.									Y					OTH	OTH	LEVOTHYROXINE; CYMBALTA; SINGULAIR.	Migraine			MEDI0007179	1						1	Accidental exposure; Headache	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355156	08/13/2009	MI	7.5			M	10/06/2008	A non-serious spontaneous report of hives has been received from a registered nurse concerning a 7.5-year old male patient subsequent to FLUMIST.  No medical or drug history were reported for this patient. The patient received FLUMIST into both nostrils on 06-Oct-2008.  The patient developed hives ten minutes following the administration of FLUMIST.  The hives were distributed on the patient's bilateral thighs and on the forearms.  The patient was treated with DIPHENTYDRAMINE 25 milligrams.  There were no breathing problems noted.  The patient was reportedly calm in approximately one hour.  The adverse event was less prominent as well.									N	10/06/2008	10/06/2008	0		MIL	OTH	Concomitant Drug(s) Not Reported				MEDI0007181	1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500559P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355157	08/13/2009	MT	19.0			M	11/07/2008	A non-serious report of administration of expired FLUMIST was received from a health care professional concerning a 19-year-old male.  The patient's medical history and concomitant medications were not reported.  On 06-Oct-2008, the patient was given FLUMIST via nasal administration by an immunization health technician.  The vaccine was found to be expired when a nurse in the same clinic noted that the lot # of the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot # of the other supply of FLUMIST with expiration date of 25-Dec-2008.  The expired lot of FLUMIST was given to 17 adult individuals including this patient.  The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Additional information received on 07-Nov-2008:  Follow-up call to reporter revealed that no adverse events have occurred to date.									Y	10/06/2008	10/06/2008	0		MIL	OTH	Concomitant Drug (s) Not Reported.				MEDI0007182	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355158	08/13/2009	MT	18.0			M	11/07/2008	A non-serious report of administration of expired FLUMIST was received from a military non-commissioned officer and a health care professional an 18-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, FLUMIST was given via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot number of the administered FLUMIST (24-Mar-2008) was different from the lot number of the other supply of FLUMIST with expiration date of 25-Dec-2008. The expired lot of FLUMIST was given to 17 adult individuals including this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	10/06/2008	10/06/2008	0		MIL	OTH	Concomitant Drug(s) Not Reported				MEDI0007183	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355159	08/13/2009	MT	21.0			M	11/07/2008	A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer and a health care professional concerning a 21-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, the patient was given FLUMIST via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot# of the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot# of the other supply of FLUMIST with expiration date of 25-Dec-2008. The expired lot of FLUMIST was given to 17 adult individuals including this patient. The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Compliant Investigation results.									Y	10/06/2008	10/06/2008	0		MIL	OTH	Concomitant Drug(s) Not Reported				MEDI0007184	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355160	08/13/2009	MT	26.0			F	11/07/2008	A non-serious report of administration of expired FluMist was received from an Air Force non-commissioned officer and a health care professional in the USA concerning a 26-year-old female. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, the patient was given FluMist via nasal administration by an immunization health technician. The vaccine was found to be expired (expiration date 24-Mar-2008). The expired lot of FluMist was given to 17 adult individuals including this  patient. The reporter stated that prior to being informed by the immunization clinic, the expired lot of FluMist was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product complaint Investigation results									Y	10/06/2008	10/06/2008	0		MIL	OTH	Not Reported				MEDI0007185	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355161	08/13/2009	MT	21.0			M	11/07/2008	A non-serious report of administration of expired FLUMIST was received from a healthcare professional concerning a 21-year-old male.  The patient's medical history and concomitant medications were not reported.  On 06-Oct-2008, the patient presented at the base clinic and received FLUMIST via nasal administration by an immunization health technician.  The vaccine was found to be expired (expiration date 24-Mar-2008).  The expired lot of FLUMIST was given to 17 adult individuals including this patient.  The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.  Follow-up information was received on 09-Apr-2009:  Product Complaint Investigation results.									Y	10/06/2008	10/06/2008	0		MIL	OTH	Concomitant Drug (s) Not Report.				MEDI0007186	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355162	08/13/2009	MT	22.0			F	11/07/2008	A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer and a health care professional concerning a 22-year-old female.  The patient's medical history and concomitant medications were not reported.  On 06-Oct-2008, the patient presented at the base clinic and was given FLUMIST via nasal administration by an immunization health technician.  The vaccine was found to be expired (expiration date 24-Mar-2008).  The expired lot of FLUMIST was given to 17 adult individuals including this patient.  The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.  Follow-up information was received on 09-Apr-2009:  Product Complaint Investigation results.									Y	10/06/2008	10/06/2008	0		MIL	OTH	Concomitant Drug (s) Not Reported				MEDI0007187	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355163	08/13/2009	NC	5.0			M	10/06/2008	A non-serious, spontaneous report of sore throat, fever, body ache, runny nose and congestion was received from  a consumer, concerning a five year-old male patient, subsequent to FLUMIST.  Neither relevant medical history nor concomitant medications have been reported for this patient.  The patient received FLUMIST on Monday, 29-Sep-2008.  On Tuesday, 30-Sep-2008 the patient experienced a sore throat, fever, body aches, runny nose and congestion, which are ongoing.  The events were ongoing as of Monday, 06-Oct-2008.									N	09/29/2008	09/30/2008	1		PVT	OTH	Concomitant Drug (s) Not Reported.				MEDI0007188	1						1	Oropharyngeal pain; Pain; Pyrexia; Rhinorrhoea; Upper respiratory tract congestion	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355164	08/13/2009	TX	7.0			F	10/06/2008	A non-serious labeled, spontaneous report of sneezing has been received from a nurse for a seven-year-old female, subsequent to receiving FLUMIST.  No medical history or concomitant medications were provided.  The child received one dose of FLUMIST nasally on 06-Oct-2008.  The reporter indicated that on 06-Oct-2008 the child sneezed immediately after administration of FLUMIST into the first nostril.  No sneezing or event occurred after administration into the second nostril.  The event has resolved.									Y	10/06/2008	10/06/2008	0		PVT	OTH	Concomitant Drug (s) Not Reported.				MEDI0007189	1						1	Immediate post-injection reaction; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~500544P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355165	08/13/2009	MT	21.0			M	11/07/2008	A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer/health care professional concerning a 21-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, FLUMIST was given via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot number of the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot number of the other supply of FLUMIST with expiration date of 25-Dec-2008. The expired lot of FLUMIST was given to 17 adult individuals including this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	10/06/2008	10/06/2008	0		MIL	OTH	Concomitant Drug (s) Not Reported				MEDI0007190	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355166	08/13/2009	MT	34.0			M	11/07/2008	A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer/health care professional concerning a 34-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, FLUMIST was given via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot number of the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot number of the other supply of FLUMIST with expiration date of 25-Dec-2008. The expired lot of FLUMIST was given to 17 adult individuals including this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not application, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	10/06/2008	10/06/2008	0		MIL	OTH	Concomitant Drug(s) Not Reported				MEDI0007191	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355167	08/13/2009	MT	31.0			M	11/07/2008	A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer and a health care professional concerning a 31-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, the patient was given FLUMIST via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot# of the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot# of the other supply of FLUMIST with expiration date of 25-Dec-2008. The expired lot of FLUMIST was given to 17 adult individuals including this patient. The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	10/06/2008	10/06/2008	0		MIL	OTH	Concomitant Drug(s) Not Reported				MEDI0007192	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355168	08/13/2009	MT	24.0			M	11/07/2008	A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer/health care professional concerning a 24-year-old-male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, FLUMIST was given via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot number of the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot number of the other supply of FLUMIST with expiration date of 25-Dec-2008. The expired lot of FLUMIST was given to 17 adult individuals including this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 07-Nov-2008 and incorporated into the narrative: No adverse events have been reported for the patient after one month of follow-up.									Y	10/06/2008	10/06/2008	0		MIL	OTH	Concomitant Drug (s) Not Reported				MEDI0007193	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355169	08/13/2009	MT	21.0			M	11/07/2008	A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer and a health care professional concerning a 21-year-old male.  The patient's medical history and concomitant medications were not reported.  On 06-Oct-2008, the patient was given FLUMIST via nasal administration by an immunization health technician.  The vaccine was found to be expired when a nurse in the same clinic noted that the lot# of the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot# of the other supply of FLUMIST with expiration date of 25-Dec-2008.  The expired lot of FLUMIST was given to 17 adult individuals including this patient.  The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.  Follow-up information was received on 09-Apr-2009:  Product Complaint Investigation results.									Y	10/06/2008	10/06/2008	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0007194	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355170	08/13/2009	MT	25.0			M	11/07/2008	A non-serious report of administration of expired FLUMIST was received from a military non-commissioned officer and a health care professional concerning a 25-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, the patient was given FLUMIST via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot# of the other supply of FLUMIST with expiration date of 25-Dec-2008. The expired lot of FLUMIST was given to 17 adult individuals including this patient. The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	10/06/2008	10/06/2008	0		MIL	OTH	Concomitant Drugs(s) Not Reported		Medical history not reported		MEDI0007195	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355171	08/13/2009	MT	22.0			M		A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer concerning a 22-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, the patient was given FLUMIST via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot# of the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot# of the other supply of FLUMIST with expiration date of 25-Dec-2008. The expired lot of FLUMIST was given to 17 adult individuals including this patient. The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal. There was no adverse event associated with this medication error at the time of the report, nor upon follow-up of the event; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 09-Apr-2009 and incorporated into the narrative: added Product Complaint Investigation results.									Y	10/06/2008	10/06/2008	0		MIL	OTH	Concomitant Drug(s) Not Reported				MEDI0007196	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355172	08/13/2009	MT	37.0			M	04/09/2009	A non-serious report of administration of expired FluMist was received from a non-commissioned officer and a health care professional concerning a 37-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, the patient received FluMist via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot# of the administration FluMist (expiration date 24-Mar-2008) was different from the lot# of the other supply of FluMist with expiration date of 25-Dec-2008. The expired lot of FluMist was given to 17 adult individuals including this patient. The reporter stated that prior to being informed by the immunization clinic, the expired lot of FluMist was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal. There was no adverse event associated with this medication error at the time of the initial report, nor at the time that follow-up was obtained, therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customer not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 09-Apr-2009: product complaint investigation results.									Y	10/06/2008	10/06/2008	0		MIL	OTH	Not Reported				MEDI0007197	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355173	08/13/2009	MT	21.0			F		A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer and a health care professional concerning a 21-year-old female. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, the patient presented herself at the base clinic for an unscheduled immunization. FLUMIST was given via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot# of the administered FLUMIST was different from the lot# of the other supply of FLUMIST with expiration date of 25-Dec-2008. There is no information whether the FLUMIST used on 06-Oct-2008 was taken out from the immunization clinic's refrigerator or whether it was delivered to the clinic on that day. On the same day, the immunization clinic informed the logistics office which handles storage of vaccine that expired lot of FLUMIST was given to 17 adult individuals including this patient. The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 07-Nov-2008 and incorporated into the narrative: no adverse events reported. Additional information received on 09-Apr-2009 and incorporated into the narrative: add Product Complaint Investigative results.									Y	10/06/2008	10/06/2008	0		MIL	OTH	Concomitant Drug (s) Not Reported				MEDI0007198	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355174	08/13/2009	MT	19.0			M		A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer and a health care professional concerning a 19-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, the patient presented himself at the base clinic for an unscheduled immunization. FLUMIST was given via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot# of the administered FLUMIST was different from the lot# of the other supply of FLUMIST with expiration date of 25-Dec-2008. There is no information whether the FLUMIST used on 06-Oct-2008 was taken out from the immunization clinic's refrigerator or whether it was delivered to the clinic on that day. On the same day, the immunization clinic informed the logistics office which handles storage of vaccine that expired lot of FLUMIST was given to 17 adult individuals including this patient. The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 07-Apr-2008 and incorporated into the narrative: no adverse events reported. Additional information received on 09-Apr-2009 and incorporated into the narrative: added Product Complaint Investigation results.									Y	10/06/2008	10/06/2008	0		MIL	OTH	Concomitant Drug(s) Not Reported				MEDI0007199	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355175	08/13/2009	MT	20.0			M	04/09/2009	A non-serious report of administration of expired FLUMIST was received for a health care professional concerning a 20-year-old male.  The patient's medical history and concomitant medications were not reported.  On 06-Oct-2008, FLUMIST was given via nasal administration by an immunization health technician.  The vaccine was found to be expired when a nurse in the same clinic noted that the lot number of the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot number of the other supply of FLUMIST with expiration date of 25-Dec-2008.  The expired lot of FLUMIST was given to 17 adult individuals including this patient.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information received on 07-Nov-2008 and incorporated into the narrative:  no adverse events reported.  Additional information received 09-Apr-2009: product complaint investigation results.									Y	10/06/2008	10/06/2008	0		MIL	OTH	Concomitant Drug (s) Not Reported.				MEDI0007200	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355176	08/13/2009	TN	24.0			F	10/06/2008	A non-serious, spontaneous report of pleurisy, chest pain, shortness of breath and fever was received from a pharmacist concerning a 24 year-old female patient subsequent to FLUMIST.  The patient reported no relevant medical history.  Concomitant medications include birth control.  The patient received FLUMIST at agency on 01-Oct-2008.  On 06-Oct-2008 the patient was seen by a health care provider in the emergency room for symptoms of chest pain, shortness of breath and fever.  An electrocardiogram, chest x-ray and blood work were collected, although results were not reported.  The patient was diagnosed with pleurisy and treated with ACETAMINOPHEN, HYDROCODONE and NAPROXEN.  The patient recovered from the events on 10-Oct-2008.									Y	10/01/2008	10/06/2008	5	06-Oct-2008-Chest X-ray,  unknown result;  06-Oct-2008-EKG,  unknown result;  06-Oct-2008-Blood work, unknown result	PUB	OTH	Birth control				MEDI0007201	1						1	Blood test; Chest X-ray; Chest pain; Dyspnoea; Pleurisy; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~50045P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355177	08/13/2009	TX	5.0			F	10/07/2008	A non-serious spontaneous report of administered expired FLUMIST was received from a consumer concerning a female greater than five-years-old. No medical history was provided. The reporter indicated that the lot number and expiration date printed on the outside of the product package had a different lot number and an expiration date than the inside of the package. The outside of the package had an expiration date of Dec-2008 and the doses inside the package had an expiration date of Jan-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	10/02/2008	10/02/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007204	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500480P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355178	08/13/2009	TX	5.0			F	04/09/2009	A non-serious spontaneous report of administered expired FLUMIST was received from a consumer concerning a female greater than five-years-old. No medical history was provided. The reporter indicated that the lot number and expiration date printed on the outside of the product package had a different lot number and an expiration date than the inside to the package. The outside of the package had an expiration date of Dec-2008 and the doses inside the package had an expiration date of Jan-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	10/02/2008	10/02/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007205	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500480P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355179	08/13/2009	NM				F	10/06/2008	One of twenty-one cases:  A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse.  The event occurred in a seventh grade, adolescent female.  No medical or drug history was reported for this adolescent.  FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school.  The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose.  No adverse effects were reported; the event is considered resolved.									Y	10/03/2008	10/03/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported.		7th grade female.		MEDI0007210	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355180	08/13/2009	NM				F	10/06/2008	One of twenty-one cases:  A nonserious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse.  The event occurred in an eighth grade, adolescent female.  No medical or drug history was reported for this adolescent.  FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school.  The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip;  21 children received only half a dose.  No adverse effects were reported; the event is considered resolved.									Y	10/03/2008	10/03/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported		8th grade female		MEDI0007211	1						1	Incorrect dose administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355181	08/13/2009	NM				F	10/06/2008	One of twenty-one cases: A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eight grade adolescent female. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.									Y	10/03/2008	10/03/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported		8th grade female		MEDI0007212	1						1	Incorrect dose administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355182	08/13/2009	NM				F	10/06/2008	One of twenty-one cases:  A non - serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse.  The event occurred in an eighth grade, adolescent female.  No medical or drug history was reported for this adolescent.  FLUMIST was inadvertently administered in one nostril to 21 children during the flu clinic at an elementary school.  The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip;  21 children received only half a dose.  No adverse effects were reported; the event is considered resolved.									Y	10/03/2008	10/03/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported.		8th grade female.		MEDI0007213	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355183	08/13/2009	NM				M	10/06/2008	One of twenty-one cases:  A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse.  The event occurred in an eighth grade, adolescent male.  No medical or drug history was reported for this adolescent.  FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school.  The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider  clip; 21 children received only half a dose.  No adverse effects were reported;  the event is considered resolved.									Y	10/03/2008	10/03/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported		8th grade male		MEDI0007214	1						1	Incorrect dose administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500546F~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355184	08/13/2009	NM				F	10/06/2008	One of twenty-one cases: A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eight grade adolescent female. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.									Y	10/03/2008	10/03/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported		8th grade female		MEDI0007215	1						1	Incorrect dose administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355185	08/13/2009	NM				F	10/06/2008	One of twenty-one cases:  A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse.  The event occurred in an eighth grade adolescent female.  No medical or drug history was reported for this adolescent.  FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school.  The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip;  21 children received only half a dose.  No adverse effects were reported;  the event is considered resolved.									Y	10/03/2008	10/03/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported		8th grade female		MEDI0007216	1						1	Incorrect dose administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355186	08/13/2009	NM				M	10/06/2008	One of twenty-one cases: A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent male. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the dose had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.									Y	10/03/2008	10/03/2008	0		OTH	OTH			8th grade male		MEDI0007217	1						1	Incorrect dose administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355188	08/13/2009	NM				M	10/06/2008	One of twenty-one cases: A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent male. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administered the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.									Y	10/03/2008	10/03/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported		8th grade male		MEDI0007219	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355189	08/13/2009	NM				M	10/06/2008	One of twenty-one cases: A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent male. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the dose had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.									Y	10/03/2008	10/03/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported		8th grade male		MEDI0007221	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355190	08/13/2009	NM				F	10/06/2008	One of twenty-one cases: A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent female. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.									Y	10/03/2008	10/03/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported		8th grade female		MEDI0007222	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355191	08/13/2009	NM				M	10/06/2008	One of twenty-one cases: A non-serious, spontaneous event of half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent male. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the dose had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.									Y	10/03/2008	10/03/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported		8th grade male		MEDI0007223	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355192	08/13/2009	NM				F	10/06/2008	One of twenty-one cases: A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent female. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.									Y	10/03/2008	10/03/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported		8th grade female		MEDI0007224	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355193	08/13/2009	NM				M	10/06/2008	One of twenty-one cases:  A non-serious, spontaneous event of a half dose of FLUMIST administered was received fro ma registered nurse.  The event occurred in an eight grade adolescent male.  No medical or drug history was reported for this adolescent.  FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school.  The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose.  No adverse effects were reported; the event is considered resolved.									Y	10/03/2008	10/03/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported		8th grade male		MEDI0007225	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355194	08/13/2009	NM				M	10/06/2008	One of twenty-one cases: A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent male. No medical or drug history was reported for the adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the diver clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.									Y	10/03/2008	10/03/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported		8th grade male		MEDI0007227	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355195	08/13/2009	NM				M	10/06/2008	One of twenty-one cases: A non-serious, spontaneous event of a half dose to FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent male. Now medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in on nostril to 21 children during a flu clinic  at an elementary school. The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported the event is considered resolved.									Y	10/03/2008	10/03/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported		8th grade male		MEDI0007228	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355196	08/13/2009	NM				M	10/06/2008	One of twenty-one cases: A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent male. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the dose had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.									Y	10/03/2008	10/03/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported		8th grade male		MEDI0007229	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355197	08/13/2009	NM				M	10/06/2008	One of twenty-one cases: A non serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent male. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in on nostril to 21 children during a flu clinic at an elementary school. The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.									Y	10/03/2008	10/03/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported		8th grade male		MEDI0007230	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355279	08/13/2009	NM				M	10/06/2008	One of twenty-one cases: A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in and eighth grade adolescent male. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported the event is considered resolved.									Y	10/03/2008	10/03/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported		8th grade male		MEDI0007231	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355284	08/13/2009	NM				F	10/06/2008	One of twenty-one cases: A non-serious spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent female. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.									Y	10/03/2008	10/03/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported		8th grade female		MEDI0007232	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355286	08/13/2009	IA	85.0			F	10/21/2008	A non-serious spontaneous report of inadvertent administration to an 85-year old was received from a physician concerning an 85 year old female patient. Upon follow-up inquiry, the reporter confirmed that no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was obtained on 21-Oct-2008 and incorporated into the narrative: Confirmation from the reporter that no adverse event occurred from the administration of FLUMIST to an 85-year old.									Y	10/09/2008	10/09/2008	0		PVT	OTH	Concomitant Drugs (s) Not Reported				MEDI0007237	1						1	Wrong drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500557P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355287	08/13/2009	SD	24.0			M	10/09/2008	A non-serious, spontaneous report of positive for type A influenza virus, productive cough, sore throat, runny nose, chills, body ache and malaise was received from a nurse concerning a 24 year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 29-Sep-2008. On 05-Oct-2008 the patient developed symptoms of productive cough, sore throat, runny nose, chills, body ache and malaise. He was evaluated on 09-Oct-2008 and an influenza test was positive for type A influenza virus. The outcome for the reported adverse events was not reported.									U	09/29/2008	10/05/2008	6	Influenza serology, 10/09/2008, Positive for type A influenza virus	MIL	OTH	Concomitant Drug (s) Not Reported				MEDI0007242	1						1	Chills; Influenza; Influenza serology positive; Malaise; Oropharyngeal pain; Pain; Productive cough; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500557~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355290	08/13/2009	NJ				F	10/09/2008	A non-serious spontaneous report of post-nasal drip taste, bad cold, sneezing, and running nose has been received from a female patient of unknown age subsequent to FLUMIST.  No medical history or concomitant medications were provided.  The patient received FLUMIST on an unknown date.  A consumer reported her experience after receiving FLUMIST.  Per the reporter, initially, there was no reaction but then she developed a post-nasal drip taste, the next day and three days after she had sneezing and runny nose; it felt like I had gotten a bad cold.  The patient had not received a flu immunization in 15 years.  Outcome was not reported.  Per the reporter, she will take the shot next time.									U					OTH	OTH	Concomitant Drug (s) Not Reported.				MEDI0007243	1						1	Dysgeusia; Nasopharyngitis; Rhinorrhoea; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355292	08/13/2009	FL	48.0			M	10/22/2008	A non-serious, spontaneous report of dosage to left nostril never misted/sprayed was received from a consumer, concerning a 48 year-old male patient subsequent to FLUMIST. Neither the patient's medical history nor concomitant medications were reported. As of thirteen days after administration of FLUMIST, the patient denies any occurrence of illness or adverse events. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Additional information received on 22-Oct-2008: confirmed that the patient did not experience any adverse effects.									Y	10/09/2008	10/09/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007246	1						1	Incorrect dose administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355294	08/13/2009	KY	45.0			F	10/13/2008	A non-serious Spontaneous report of partial dose was received from a nurse practitioner concerning a 45 year old female. On 13-Oct-2008, the patient received a dose of FLUMIST in the left nostril, which ran back out of the nostril. The patient did not receive administration into the right nostril. There were no adverse events; however, the clinic recommended that the patient receive the traditional vaccine shot next month. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	10/13/2008	10/13/2008	0		OTH	OTH	Concomitant Drug (s) Not Required				MEDI0007254	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~500556P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355297	08/13/2009	CO	28.0			F	10/30/2008	A non-serious, spontaneous report of gave half of vaccine was received from a nurse concerning a 28 year-old female subsequent to FLUMIST. The nurse reported she did not remember to remove the clip from the FLUMIST pre-filled syringe and thinks that she only gave one half of the vaccine. There were no additional events to report after follow-up on day thirteen after vaccination. The patient was re-vaccinated. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Additional information was received on 30-Oct-2008 and incorporated into the narrative: telephone contact received; no adverse events occurred and the patient was re-vaccinated.									Y	10/17/2008	10/17/2008	0		OTH	PVT	Concomitant Drug (s) Not Reported				MEDI0007293	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355298	08/13/2009	OH	43.0			F	10/14/2008	A non-serious, spontaneous report of sore and stiffness in back, neck and shoulders was received from a consumer, concerning a 43 year-old female patient subsequent to FLUMIST. The patient reported no relevant medical history. Concomitant medications include lisdexamfetamine dimesylate. The patient received FLUMIST on 11-Oct-2008 for flu vaccination. That evening the patient reported soreness and stiffness in the back, neck and shoulders. The patient was seen by her primary care physician and suggested the events may be related to physical exertion earlier in the day. The events were ongoing as of 17-Oct-2008 and described as soreness occurring in the triangular area at the base of the back of the neck.									N	10/11/2008	10/11/2008	0		PUB	OTH	VYVANSE				MEDI0007255	1						1	Arthralgia; Back pain; Joint stiffness; Musculoskeletal stiffness; Neck pain	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355299	08/13/2009	CO	7.0			M	10/20/2008	A non-serious spontaneous report of gave half of vaccine was received from a nurse concerning a seven-year-old male. The nurse forgot to remove the clip and administered half of the pre-filled FLUMIST syringe. The patient was re-vaccinated at a later date. There was no adverse event associated with this medication error at the time of the report, nor on 30-Oct-2008; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information received 30-Oct-2008 and incorporated into the above narrative: No adverse event occurred and the patient was re-vaccinated.									Y	10/17/2008	10/17/2008	0		OTH	PVT	Concomitant Drug (s) Not Reported				MEDI0007294	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355300	08/13/2009	GA				M	11/03/2008	A non-serious spontaneous report of received FLUMIST vaccine via parental (IM) injection has been received from a physician and a combat medic concerning a male soldier. Medical history and concomitant medication were not reported. On 17-Oct-2008, the patient received FLUMIST via parental (intramuscular) injection in the upper arm along with four other soldiers. The medic removed the cap and attached a needle to the end of the FLUMIST syringe. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow up information received on 30-Nov-2008, 17 days after the patient received FLUMIST, indicated that there were no adverse events.									Y	10/17/2008	10/17/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007296	1						1	Incorrect route of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355301	08/13/2009	GA				M	11/03/2008	A non-spontaneous report of received FLUMIST vaccine via parenteral (IM) injection has been received from a physician and a combat medic concerning a male soldier. Medical history and concomitant medication were not reported. On 17-Oct-2008, the patient received FLUMIST via parenteral (intramuscular) injection in the upper arm along with four other soldiers. The medic removed the cap and attached a needle to the end of the FLUMIST syringe. There was no adverse event associated with this medication error; therefor, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow up information received on 03-Nov-2008, 17 days after the patient received FLUMIST, indicated that there were no adverse events.									Y	10/17/2008	10/17/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007297	1						1	Incorrect route of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355302	08/13/2009	MA	7.0			M	10/30/2008	A non-serious, spontaneous report of patient pulled back on one nare and small amount of FLUMIST was sprayed into one eye was received from a physician concerning a seven year-old female patient, subsequent to FLUMIST. Neither medical history nor concomitant medications have been reported for this patient. There were no adverse events reported 15 days after administration. There was no adverse events associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.									Y	10/15/2008	10/15/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007268	1						1	Accidental exposure	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355303	08/13/2009	GA				M	11/03/2008	A non-serious spontaneous report of received FLUMIST vaccine via parenteral (IM) injection has been received from a physician and a combat medic concerning a male soldier. Medical history and concomitant medication  were not reported. On 17-Oct-2008, the patient received FLUMIST via parenteral (intramuscular) injection in the upper arm along with four other soldiers. The medic removed the cap and attached a needle to the end of the FLUMIST syringe. There was no adverse associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow up information received on 03-Nov-2008, 17 days after the patient received FLUMIST, indicated that there were no adverse events.									Y	10/17/2008	10/17/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007298	1						1	Incorrect route of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355304	08/13/2009	GA				M	11/03/2008	A non-serious spontaneous report of received FLUMIST vaccine via parenteral (IM) injection has been received from a physician and a combat medic concerning a male soldier.  Medical history and concomitant medication were not reported.  On 17-Oct-2008, the patient received FLUMIST via parenteral (intramuscular) injection in the upper arm along with four other soldiers.  The medic removed the cap and attached a needle to the end of the FLUMIST syringe.  There was no adverse event  associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Follow up information received on 03-Nov-2008, 17 days after the patient received FLUMIST, indicated that there were no adverse events.									Y	10/17/2008	10/17/2008	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0007299	1						1	Incorrect route of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355305	08/13/2009	KS	8.0			M	11/07/2008	A non-serious, spontaneous report of FLUMIST sprayed in the eye  was received from a nurse, concerning an eight-year-old male patient while receiving FLUMIST.  There was no adverse event associated with this medication error;  therefore treatment and reporter/sponsor causality assessment are not applicable and the event is considered resolved.  Additional information received 07-Nov-2008:  No additional adverse events have been reported for the patient since vaccination.									Y	10/17/2008	10/17/2008	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0007300	1						1	Accidental exposure	FLUN3~MEDIMMUNE VACCINES, INC.~500560~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355306	08/13/2009	UT	7.0			F	10/16/2008	A non-serious, spontaneous report of asthmatic patient given FLUMIST was received from a physician assistant concerning a seven year-old female patient.  No medical history was reported.  The patient also received varicella vaccine on the same day as receipt of FLUMIST vaccine.  There was no adverse event associated with this medication error;  therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.									Y	10/15/2008	10/15/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported	Asthma			MEDI0007277	1						1	No adverse event; Wrong drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~UNKNOWN MANUFACTURER~~UNK~UN~UN~VARICELLA (NO BRAND NAME)~1	USA		Influenza
0355307	08/13/2009	NC	52.0	52		M	10/20/2008	A non-serious, spontaneous report of vaccination of 52-year-old was received from a consumer, involving a 52-year-old male patient subsequent to FLUMIST. The event was reported 14 days after the administration and the consumer indicated there were no symptoms or problems. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.									Y	10/06/2008	10/06/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007301	1						1	Inappropriate schedule of drug administration; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355308	08/13/2009	TX	69.0	69		U	10/20/2008	A non-serious, spontaneous report of administered FLUMIST to an adult greater in age than 49, was received from a physician, involving a a 69-year-old patient subsequent to FLUMIST. The event was reported 19 days after the administration and the physician indicated that the patient was doing fine and no reactivity was reported. There was no adverse associated with this medication error; therefore treatment and reporter/sponsor causality assessment are not applicable and the event is considered resolved.									Y	10/01/2008	10/01/2008	0		PVT	OTH	Concomitant Drug (s) Not Reported				MEDI0007302	1						1	Inappropriate schedule of drug administration; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500543P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355309	08/13/2009	KS	16.0			F		A non-serious report of inadvertently given FLUMIST  has been received from a health department representative concerning a 16-year-old female, subsequent to FLUMIST. The patient's past medical history included being 20 weeks pregnant. No concomitant medications were reported. On 16-Oct-2008 a patient who was 20 weeks pregnant was inadvertently administered FLUMIST. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during pregnancy.									N	10/16/2008	10/16/2008	0		PUB	OTH	Concomitant Drug (s) Not Reported	Pregnant (10036586)			MEDI0007279	1						1	Drug exposure during pregnancy	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355310	08/13/2009	MD	56.0			M	10/30/2008	A non-serious spontaneous report of FLUMIST should not have been given was received from a registered nurse concerning a 56-year old male patient. No medical or medication history was reported for this patient. According to the report, the patient presented to the Health Center and stated that he wanted to receive FLUMIST vaccine. The patient did not report his age to the health center staff. The nurse who administered the vaccine only noticed the patient's age in the patient's chart after FLUMIST administration. Upon follow-up inquiry, the reporter confirmed that there was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was obtained on 30-Oct-2008 and incorporated into the narrative: confirmation from the reporter that no adverse events occurred from the administration of FLUMIST.										10/15/2008	10/15/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007284	1						1	Inappropriate schedule of drug administration; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500526~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355311	08/13/2009					F	10/15/2008	A non-serious, spontaneous report of secondary transmission of flu, muscle cramps, headache and chills has been received from a consumer concerning an adult female, subsequent to second hand exposure to FLUMIST. No medical history or concomitant medication information was provided. The patient's sister took her two children to receive FLUMIST on 09-OCT-2008. The children then spent the week-end starting 10-Oct-2008 away from home. On an unreported date in mid 0ct-2008 the patient experienced muscle cramps, headache and chills. The patient picked up her children from school on 15-Oct-2008. She went to the urgent care center for chills, headache and muscle cramps. The reporter states She said the doctor there told her she probable got the flu from her kids. No outcome was reported.									U	10/09/2008				UNK	UNK	Concomitant Drug (s) Not Reported		Adult female with second hand exposure to FLUMIST		MEDI0007304	1						1	Chills; Headache; Influenza; Muscle spasms; Secondary transmission	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355312	08/13/2009	TX	76.0	76		U	10/20/2008	A non-serious, spontaneous report of administered FLUMIST to adult greater in age than 49, from a physician involving a 76 year-old patient subsequent to FLUMIST. The event was reported 19 days after the administration and the physician indicated the patient was doing fine and no reactivity was reported. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.									Y	10/01/2008	10/01/2008	0		PVT	OTH	Concomitant Drug (s) Not Reported				MEDI0007305	1						1	Inappropriate schedule of drug administration; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500543P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355313	08/13/2009	OH	62.0			F	11/07/2008	A non-serious, spontaneous report of gave 62-year old female FLUMIST, was received from a health professional, subsequent to FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Additional information on 07-Nov-2008: No additional adverse events have been reported for the patient since vaccination.									Y	10/21/2008	10/21/2008	0		PVT	OTH	Concomitant Drug (s) Not Reported				MEDI0007307	1						1	Inappropriate schedule of drug administration; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355314	08/13/2009	NC	7.0	7		M	10/21/2008	A non-serious, spontaneous report of vomiting was received from a Registered Nurse concerning a seven year-old male patient, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 21-Oct-2008 the patient received FLUMIST. On 21-Oct-2008, the patient vomited within a couple of hours of receiving FLUMIST. The outcome for the adverse event was not reported.									U	10/21/2008	10/21/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007308	1						1	Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500541P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355315	08/13/2009	OH	5.0	5		M	10/21/2008	A non-serious report of Henoch Schonlein Purpura, abdominal pain, joint pain, and rash below the waist line has been received from a nurse concerning a five year-old male. No medical history nor concomitant medications were provided. On 27-Sep-2008, the patient received a dose of FLUMIST. Within hours after receiving FLUMIST on the same day, on 27-Sep-2008, the patient experienced rash below the waist line, abdominal pain and joint pain. The patient was brought to the emergency room by his mother. In the ER, unspecified tests were performed and treatments were administered. The patient was diagnosed with Henoch Schonlein Purpura. The patient was released from the ER and instructed to follow-up with the primary pediatrician. Outcome for the events was considered resolving. The responsible physician assessed the events as not related to FLUMIST.									N	09/27/2008	09/27/2008	0	Urine test- Unknown	PUB	PUB	Concomitant Drug (s) Not Reported				medi0007313	1						1	Abdominal pain; Arthralgia; Henoch-Schonlein purpura; Rash; Urine analysis	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355317	08/13/2009	KY				M	10/17/2008	A non-serious, spontaneous report of FLUMIST misted into eye of male child between six and twelve years of age was received from a nurse. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.									Y	10/17/2008	10/17/2008	0		PUB	OTH	Concomitant Drug (s) Not Reported				MEDI0007285	1						1	Accidental exposure	FLUN3~MEDIMMUNE VACCINES, INC.~500558P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355318	08/13/2009	FL	5.0	5		F	10/17/2008	A non-serious report of runny nose and fever was received from a consumer concerning a five-year-old female. No medical history or concomitant medications were reported. The patient received FLUMIST on 13-Oct-2008. On 15-Oct-2008, two days after receiving FLUMIST, the patient and her sibling developed runny nose; the following day on 16-Oct-2008, the patient developed a fever. The event of runny nose and fever resolved on 17-Oct-2008.									Y	10/13/2008	10/15/2008	2		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007291	1						1	Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355319	08/13/2009	GA	28.0	28		M	11/03/2008	A non-serious spontaneous report of received FLUMIST vaccine via parenteral (IM) injection has been received from a physician (patient's father) and a combat medic concerning a 28-year-old male soldier. Medical history and concomitant medication were not reported. On 17-Oct-2008, the patient received FLUMIST via parenteral (intramuscular) injection in the upper arm along with four other soldiers. The medic removed the cap and attached a needle to the end of the FLUMIST bottle. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow up information received 03-Nov-2008, 17 days after the patient received FLUMIST, indicated that there were no adverse events.									Y	10/17/2008	10/17/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007292	1						1	Incorrect route of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355320	08/13/2009	MN	10.0			F	10/21/2008	A non-serious, spontaneous report of administration to asthmatic was received from a pharmacist, concerning a ten year-old female patient, subsequent to FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.									Y	10/20/2008	10/20/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported	Asthma			MEDI0007316	1						1	Wrong drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355321	08/13/2009	KY	9.0			M	10/22/2008	A non-serious, spontaneous report of full dose of FLUMIST in one nostril was received from a consumer, concerning a nine year-old patient. The pharmacist administering the dose placed all 0.2 ml into one nostril, disregarding the diver clip on the sprayer device. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.									Y	10/21/2008	10/21/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007317	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355322	08/13/2009	MO	12.0	12		F	10/30/2008	A non-serious spontaneous report of generalized hives has been received from a Registered Nurse concerning a 12-year-old female, subsequent to FLUMIST. Medical history included attention deficit/hyperactivity disorder (ADHD) and childhood epilepsy. Concomitant medication included methylphenidate hydrochloride. The patient's brother or sister experienced hives with the diphtheria, tetanus, and DTP vaccine at 18 months old. On 19-Oct-2008, the patient received FLUMIST, intranasal administration. She had never received FLUMIST before. One hour post administration of FLUMIST, the patient broke out in generalized hives. The hives progressively worsened over the next two days. No other symptoms were reported. The patients mother treated her with diphenhydramine. The outcome of the event was not reported. Additional information received on 30-Oct-2008 and incorporated into the narrative included in medical history concomitant medication and vaccine information.									U	10/19/2008	10/19/2008	0		PUB	PVT	RITALIN	ADHD, Epilepsy	Brother or sister experienced hives with the diphtheria, tetanus, and DTP vaccine at 18 months old.		MEDI0007318	1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500557P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355323	08/13/2009	IN	13.0			F	01/08/2009	A non-serious spontaneous report of severe headache has been received from a nurse concerning a 13-year-old female, subsequent to FLUMIST. No relevant medical history has been reported for this patient, who also received a HPV injection at the same time as FLUMIST. The patient received FLUMIST on 13-Oct-2008. The patient experienced a severe headache on 13-Oct-2008 after receiving FLUMIST and the HPV. The reporter stated that the patient was apprehensive about getting the HPV injection and thinks that the headache may have resulted from the patients intense apprehension related to receiving the HPV injection. The patient presented to the ER  and CAT scan was negative on 14-Oct-2008. The headache resolved on 15-Oct-2008. Additional information received 08-Jan-2009 and incorporated into the case: outcome and resolution date.									Y	10/13/2008	10/13/2008	0	CAT Scan, 10/14/2008, Negative	PVT	PVT	Concomitant Drug (s) Not Reported				MEDI0007319	1						1	Computerised tomogram normal; Headache; Nervousness	FLUN3~MEDIMMUNE VACCINES, INC.~500549P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~~UNK~IM~UN~HPV (GARDASIL)~1	USA		Influenza
0355324	08/13/2009	NV	50.0			M	10/22/2008	A non-serious spontaneous report of a 50-year-old male patient who experienced arthralgia and malaise subsequent to FLUMIST has been received from a physician (patient). No relevant medical and medication history was reported. The patient received FLUMIST on 18-Sep-2008. Two days after FLUMIST administration, the patient experienced malaise and general arthralgia which lasted for about four days. At the time of report, the patient had no symptoms.									Y	09/18/2008	09/18/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007320	1						1	Arthralgia; Malaise	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355325	08/13/2009	MN	34.0			M	11/06/2008	A non-serious spontaneous report of patient received only half a dose was received from a registered nurse concerning a 34-year old male patient. On 23-Oct-2008, the patient received only half a dose (0.1 ml) of FLUMIST because the divider clip was not removed. upon inquiry, the reporter confirmed that there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was obtained on 06-Nov-2008 and incorporated into the narrative: confirmation from the reporter that no adverse events occurred from the medication error.									Y	10/23/2008	10/23/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007329	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355326	08/13/2009	MN	5.0			M	10/23/2008	A non-serious spontaneous report of a second dose of FLUMIST given two weeks after first dose was received from a registered nurse concerning a five-year-old male. The patient's medical history and concomitant medications were not reported. On 09-Oct-2008 the patient received FLUMIST vaccine. two weeks later, on 23-Oct-2008, the patient received a second dose of FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	10/23/2008	10/23/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007330	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500558P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355327	08/13/2009	IL	8.0			M	11/07/2008	A non-serious, spontaneous report of inflammation of the face iwth swelling and itching was received from a nurse, concerning an eight year-old male patient, subsequent to FLUMIST. The patient was not taking any concomitant medications. The patient has no known allergies or history of hypersensitivity. The patient received FLUMIST, nasal on 22-Oct-2008 for flu vaccinations. Twelve hours after administration of FLUMIST, the child experienced inflammation of the face with swelling and itching. There was no report of difficulty breathing or swelling of the tongue or throat. The nurse advised the parent to administer the patient diphenhydramine by mouth. The symptoms were ongoing at time of reporting on 24-Oct-2008 The outcome of the events is unknown.									U	10/22/2008	10/22/2008	0		PVT	OTH	Concomitant Drug(s) Not Used		No known allergies or history of hypersensitivity.		MEDI0007331	1						1	Inflammation; Pruritus; Swelling face	FLUN3~MEDIMMUNE VACCINES, INC.~500550P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355328	08/13/2009	IN	13.0			M	10/24/2008	A serious spontaneous report of paralysis on the right side of his face was received from the mother of the patient concerning a 13 year-old male subsequent to FLUMIST.  Medical history included allergies and concomitant medication included fluticasone propionate.  The patient received a dose of FLUMIST on 13-Oct-2008.  A total of one dose was received before onset of the event which occurred eight days later.  The child's mother called to report her son on 21-Oct-2008 complained of paralysis on the right side of her face.  The child stated that, my right eye will not shut right and my smile does not work.  He was taken to an urgent care clinic on 22-Oct-2008 where blood work was drawn but no diagnosis was given.  On 24-Oct-2008 the child was seen by his primary physician who tested for Lyme's disease and was negative.  The child was seen by a Neurologist, exam was negative except for an initial tongue extension test that initially showed deviation to the left but a re-test showed straight extension.  The mother stated that there were no plans for future diagnostic imaging.  Per the mother the child continues to exhibit symptoms no improvement or worsening of condition was noted.  The mother stated that the Neurologist believes the child's symptoms may be attributed to either a virus or FLUMIST.									N	10/13/2008	10/21/2008	8	Lyme's Disease:  Negative test	OTH	OTH	FLONASE	Allergy			MEDI0007333	1						1	Borrelia burgdorferi serology negative; Facial palsy	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355329	08/13/2009	UT	8.0			U	03/24/2009	A non-serious spontaneous report of administered expired FLUMIST was received from a health care worker concerning an eight year old child. No medical history was provided. The reporter indicated that outdated FLUMIST was administered to two children on 24-Oct-2008 (expiration date 10-Jan-2008). The patients were re-administered a flu shot. upon follow-up, no adverse evens were associated with this expired vaccine usage; therefore, treatment and causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information received on 24-Mar-20 included Product Complaint Investigation results.									Y	10/24/2008	10/24/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007334	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500547P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355330	08/13/2009	MN	34.0	34		M		A non-serious spontaneous report of received half dose of FLUMIST was received from a Registered Nurse concerning a 34 year-old male. The divider clip was not removed and the patient received  a half dose (0.1 ml) of FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	10/23/2008	10/23/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007337	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355331	08/13/2009	WA	37.0			F	10/27/2008	A non-serious, spontaneous report of rash was received from a pharmacist/consumer concerning a 37 year-old female subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 24-Oct-2008. On 24-Oct-2008, five minutes after administration, a rash appeared on the neck which spread over the body. The patient took diphenhydramine and now the rash only appears in a hot shower.									N	10/24/2008	10/24/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007342	1						1	Rash generalised	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355332	08/13/2009	TX	6.0			M	10/28/2008	A non-serious report of swelling of the glands has been received from a certified medical assistant (CMA) concerning a six-year old male patient, subsequent to FLUMIST.  No medical and drug history information has been reported for this patient.  The patient received 0.2 milliliters of FLUMIST on 27-Oct-2008.  According to the patient's parent, the patient experienced swelling of the glands approximately 16 hours after receiving FLUMIST, at two in the morning of 28-Oct-2008.  The patient was taken to the emergency room.  Information regarding the care the patient received in the emergency room was not available at the time of this report.  The outcome of the adverse event is unknown.									U	10/27/2008	10/28/2008	1		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007343	1						1	Lymphadenopathy	FLUN3~MEDIMMUNE VACCINES, INC.~50041P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355333	08/13/2009	NC	35.0			F	10/28/2008	A non-serious spontaneous report of secondary transmission, fever, chills and malaise was received from a 35-year-old female physician concerning herself, subsequent to her child receiving FLUMIST. Medical history and concomitant medications were not reported. The patient's child received FLUMIST on 23-Oct-2008. On 26-Oct-2008 the mother of the child who received FLUMIST, who is a physician, stated she experienced symptoms of fever, chills and malaise. The mother stated that she understood that risk of transmission was very minimal. The mother stated that on 28-Oct-2008 symptoms lasted for approximately 30 hours and she was feeling better.									Y		10/26/2008			OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007345	1						1	Chills; Malaise; Pyrexia; Secondary transmission	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355334	08/13/2009	IN	9.0	9		M	11/12/2008	A non-serious, spontaneous report of should not have gotten two doses this season, in a nine year-old male patient was received from a health professional. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Additional information received 12-Nov-2008: No reactions have been reported in the patient since vaccination.									Y	10/28/2008	10/28/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007349	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500547P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355335	08/13/2009	MN	59.0			M	11/10/2008	A non-serious spontaneous report of FLUMIST was administered to a 50-year-old was received from a registered nurse concerning a 59-year-old male patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was obtained on 10-Nov-2008: FLUMIST route of administration and confirmation from the reporter that no adverse events occurred from the administration of FLUMIST to a 59-year-old.									Y	10/29/2008	10/29/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007350	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355336	08/13/2009	WI				F	10/30/2008	A non-serious, spontaneous report of fever, congestion, muscle aches and sore throat was received from a consumer, concerning an adult female subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 22-Oct-2008. Forty-eight hours after administration the patient experienced symptoms of low grade fever, congestion, muscle aches and sorer throat. The symptoms were ongoing at the time of reporting on 30-Oct-2008.									N	10/22/2008	10/24/2008	2		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007352	1						1	Myalgia; Oropharyngeal pain; Pyrexia; Upper respiratory tract congestion	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355337	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007376	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355338	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form previous season and 2) product expiring during peak of flue season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007377	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355339	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007378	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355340	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007379	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355341	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessment are not applicable and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007380	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355342	08/13/2009	NM	58.0			F	10/29/2008	A non-serious spontaneous report of administration to a 58 year-old female was received from a Registered Nurse concerning a 58 year-old patient. A 58 year-old was given FLUMIST by mistake. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y					OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007356	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355343	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy patients, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication error that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007382	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355344	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy patients, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007383	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355345	08/13/2009	VA	30.0			F	10/30/2008	A non-serious, spontaneous report of aches, fever and sore throat was received from a consumer concerning a 30 year-old female subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 17-Oct-2008. Three days later the patient stayed in bed for 10 days and experienced aches, fever and sore throat. She was taking over-the-counter Theraflu. The outcome of the events was not reported.									U	10/17/2008	10/20/2008	3		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007357	1						1	Oropharyngeal pain; Pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355346	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007384	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355347	08/13/2009	FL	5.0			M	10/30/2008	A non-serious spontaneous report of croup and cough was received from a physician concerning a five-year-old male, subsequent to FLUMIST. No medical history or concomitant medications were reported. The patient received FLUMIST (date not reported). On 27-Oct-2008 the child experienced cough/croup and was taken to the emergency room. While there he was treated with dexamethason and albuterol. The health status of the child was reported as unchanged. The reporter stated that in his opinion FLUMIST did not cause the coughing experienced by the child. There was no report of causality for the croup.									U		10/27/2008			OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007360	1						1	Cough; Croup infectious	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355348	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007385	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355349	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007386	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355350	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007387	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355351	08/13/2009	CA				F	10/31/2008	A non-serious spontaneous report of administration to pregnant female was received from a Registered Nurse concerning an adult female. The patient's medical and obstetrical history was not reported. On 31-Oct-2008, FLUMIST was mistakenly given to a pregnant female. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable.									U	10/31/2008	10/31/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007362	1						1	Drug exposure during pregnancy	FLUN3~MEDIMMUNE VACCINES, INC.~500560P~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355352	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007388	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355353	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had and expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007389	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355354	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007390	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355355	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.  Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007391	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355356	08/13/2009	CA	8.0			M	01/13/2009	A non-serious spontaneous report of fever and vomiting has been received from a consumer concerning an 8-year-old male, subsequent to FLUMIST. Medical history and concomitant medication were not provided. On 28-Oct-2008, the patient received FLUMIST, intranasal administration. On 02-Nov-2008 the parent of the child reported his son was having symptoms of fever and vomiting. The child was not hospitalized. Per the reporter both the fever and vomiting were resolved the next day and there was no need to seek any medical treatment. On 03-Nov-2008 the events of fever and vomiting were resolved. Follow-up information was received on 13-Jan-2009 and included event outcome information. This information has been incorporated into the above narrative.									Y	10/28/2008	11/02/2008	5		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007363	1						1	Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355357	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST. The vaccine had and expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007366	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355358	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST. The vaccine had an expiration date March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007369	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355359	08/13/2009	AL	5.0	5		F	11/03/2008	A non-serious, spontaneous report of fever of 104, aches and pain was received from a physician, concerning a five-year-old female subsequent to FLUMIST. The patient was not receiving any concomitant medications and there is no relavent medical history. The patient received FLUMIST, intranasal for flu vaccination on 30-Oct-2008. On 01-Nov-2008 the child experienced fever of 104 F, aches and pain. As of 03-Nov-2008 the events resolved.									Y	10/30/2008	11/01/2008	2		PVT	OTH	Concomitant Drug (s) Not Used				MEDI0007370	1						1	Pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500577P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355360	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007371	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355361	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007392	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355362	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy patients, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007393	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355363	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007394	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355364	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007395	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355365	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had and expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007396	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355366	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had and expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007397	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355367	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had and expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007398	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355368	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had and expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007399	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355369	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had and expiration date of March 2008.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.  Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007400	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355370	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had and expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007401	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355371	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007402	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355372	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007403	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355373	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007404	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355374	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007405	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355375	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007406	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355376	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.  The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007372	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355377	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy patients, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007373	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355378	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007374	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355379	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007375	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355380	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007407	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355381	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007408	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355382	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007409	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355383	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007410	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355384	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007411	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355385	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007412	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355386	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007413	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355387	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007414	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355388	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007415	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355389	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007416	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355390	08/13/2009	PA	6.0			F	11/03/2008	A non-serious, spontaneous report of fever of 104 and hives was received from a consumer, concerning a six year-old female subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 30-Oct-2008. On 01-Nov-2008 the child experienced fever of 104 F and hives on her feet and lower back. On 02-Nov-2008 the reporter called their pediatrician and on 02-Nov-2008 was instructed to administer diphenhydramine. As of 03-Nov-2008 the fever is no longer present and the hives have subsided somewhat.									Y	10/30/2008	11/01/2008	2		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007417	1						1	Pyrexia; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355391	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007418	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355392	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007419	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355393	08/13/2009	KS				U	11/02/2008	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007420	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355394	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medication have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007421	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355395	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FluMist administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FluMist vaccine.  The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter / sponsor causality assessment are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Not Reported				MEDI0007422	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355422	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient.  Neither medical history nor concomitant medications have been reported.  On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine.  The vaccine had an expiration date of March 2008.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessment are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after product expired.  Follow-up information was received on 09-Apr-2009:  Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0007423	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355423	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy patients, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0007424	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355424	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient.  Neither medical history nor concomitant medications have been reported.  On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine.  The vaccine had an expiration date of March 2008.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication that occurred shortly after the product expired.  Follow-up information was received on 09-APR-2009:  Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0007425	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501F~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355425	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peat of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007426	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355426	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Bases on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding products from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007427	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355427	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medication have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007428	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355428	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medication have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007429	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355429	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medication have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007430	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355430	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medication have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007431	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355431	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medication have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007432	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355432	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medication have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007436	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355433	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding products from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0007437	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355434	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medication have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007438	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355435	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0007439	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355436	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medication have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007440	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355437	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding products from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0007441	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355438	08/13/2009	KS				U	04/09/2009	A non-used report of expired FluMist administered was received from  a patient. Neither medical history nor concomitant medication have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FluMist vaccine. The vaccine had an expiration date of March 2009. There was no adverse event associated with this medication error; treatment and reporter / sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customer not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors occurred shortly after the product expired. Follow up information was received on 09-Apr-2009: Product complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Not reported				MEDI0007442	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355439	08/13/2009	KS				U	04/09/2009	A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medication have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/01/2008	11/01/2008	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0007443	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500501P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355440	08/13/2009	SD	24.0	24		F	11/15/2008	A non-serious spontaneous report of administration to a pregnant female was received from a nurse practitioner concerning a 24-year old female. The patient was unaware of her pregnancy at two weeks gestation (estimated calculation obtained using the patient's last menstrual period) at the time of FLUMIST administration. The patient's obstetrical history included one pregnancy and one full-term delivery; the patient has no history of premature delivery, spontaneous abortion, elective termination, treatment for infertility, pregnancy complications and fetal/neonatal complications. The patient's second cousin reportedly has a history of retardation. There is no relevant information from the father in relation to this pregnancy. The pregnancy is ongoing at the time of this report. Treatment and reporter/sponsor causality assessments are not applicable.									U	10/16/2008	10/16/2008	0	Pregnancy test, 10/23/08, Positive	OTH	PVT	Multivitamin (Prenatal)	No illness at the time of vaccination;	2 weeks gestation at the time of FLUMIST administration; History of retardation (2nd cousin)		MEDI0007444	1						1	Drug exposure during pregnancy; Pregnancy test positive	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355441	08/13/2009	MN	27.0			F	11/05/2008	A non-serious, spontaneous report of achiness and joint pain was received from a physician concerning a 27 year-old female subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 21-Oct-2008. Within a few hours after administration the patient had symptoms of achiness and joint pain on the left side of the body. As of 05-Nov-2008 the symptoms persist.									N	10/21/2008	10/21/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007449	1						1	Arthralgia; Pain	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355442	08/13/2009	OR				F	11/04/2008	A non-serious spontaneous report of accidental exposure, influenza, fever exhaustion, coughing, headache and sneezing was received from a female adult consumer, who is a nurse, subsequent to FLUMIST. The patient administered FLUMIST years ago. The reporter stated that, twice I gave FLUMIST years ago and twice I contracted influenza. The reporter stated she was in bed for one week with exhaustion, a fever of 104, sneezing coughing and severe headache. The outcome of the events was not reported.  All follow up attemps completed.  Information not available 11-11-2009.									U					OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007450	1						1	Accidental exposure; Cough; Fatigue; Headache; Pyrexia; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355443	08/13/2009	KS	11.0			F	11/05/2008	A non-serious, spontaneous report of pain in leg, stomach pain, fever and nausea was received from a nurse, concerning an 11 year-old female subsequent to FLUMIST. There was no relevant medical history reported for the patient. Concomitant therapy include GARDASIL vaccination given on 04-Nov-2008. The patient received FLUMIST, nasal, on 04-Nov-2008 for Flu vaccination. Six hours after administration the child had symptoms of stomach pain. On the morning of 05-Nov-2008 the patient still had stomach pains along with a fever of 101F, some nausea and hurting in the legs. The health department nurse referred the child to a local medical doctor for evaluation and the patient was seen by the physician on 05-Nov-2008 for the reported symptoms. By the time the patient was seen by the physician the symptoms had gone away and per the patients mother, the daughter was all better. The treating physician informed the patient's mother events were likely related to stomach gas.									Y	11/04/2008	11/04/2008	0		PUB	OTH	Concomitant Drug(s) Not Reported				MEDI0007451	1						1	Abdominal pain upper; Nausea; Pain in extremity; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~~UNK~UN~UN~HPV (GARDASIL)~1	USA		Influenza
0355444	08/13/2009	CA	11.0	11		F	11/05/2008	A non-serious spontaneous report of migraine headaches and abdominal pain was received from a medical assistant in a physician's office concerning an 11-year-old female, subsequent to FLUMIST. The patient received FLUMIST ON 03-Nov-2008. Within several hours after the dose of FLUMIST the patient developed a migraine headache and abdominal pain. The events remained unresolved at the time of the report.									N	11/03/2008	11/03/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007454	1						1	Abdominal pain; Migraine	FLUN3~MEDIMMUNE VACCINES, INC.~505576P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355445	08/13/2009	MA				F	11/06/2008	A non-serious spontaneous report of FLUMIST syringe portion broke and caused town cuts on finger was received from a Registered Nurse in concerning a female adult of unknown age. Medical history and concomitant medications were not reported. On 04-Nov-2008, a nurse was administering FLUMIST to a patient. After removing the divider clip and depressing the plunger to the stopping point, the flange (flare) portion at the top of the barrel broke (shattered) leaving a jagged edge. The jagged edge ripped the nurse's gloves and caused two cuts on her finger. The nurse was concerned that the FLUMIST liquid went into the cuts although there was no liquid on the cuts, and inquired whether there were any safety concerns. The entire contents of the syringe was administered to the patient. The event is considered resolved.									Y		11/04/2008			UNK	UNK					MEDI0007455	1						1	Skin laceration	FLUN3~MEDIMMUNE VACCINES, INC.~500569P~UNK~OT~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355447	08/13/2009	NC	8.0			M	11/06/2008	A non-serious spontaneous report of itchy rash has been received from a certified medical assistant concerning an eight-year old male patient subsequent to FLUMIST. No relevant medical and medication history were reported for this patient. The patient received FLUMIST via nasal route at a private doctor's office during a Flu Clinic on 05-Nov-2008. Two hours after FLUMIST administration, the patient developed a rash which was described as extremely itchy. The patient recovered on the same day.									Y	11/05/2008	11/05/2008	0		PVT	PUB	Concomitant Drug(s) Not reported				MEDI0007459	1						1	Rash pruritic	FLUN3~MEDIMMUNE VACCINES, INC.~500548P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355448	08/13/2009	TN	7.0			F	11/06/2008	A non-serious, spontaneous report of rash on forehead and upper half of face was received from a pharmacist, concerning a seven-year-old female, subsequent to FLUMIST. Neither medical history nor concomitant medications have been reported. On 05-Nov-2008, the patient received FLUMIST vaccine. The following morning on 06-Nov-2008, the patient developed rash on her forehead and upper half of face. The outcome of the event was not reported.									U	11/05/2008	11/06/2008	1		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007460	1						1	Rash	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355449	08/13/2009	MN	54.0			F	11/06/2008	A non-serious spontaneous report of administration to a 54 year-old was received from a 54 year-old female consumer subsequent to FLUMIST. The patient received FLUMIST (date not reported). The consumer reported that she received FLUMIT at her church and later discovered that FLUMIST was only indicated up to age 49 years of age. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y					OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007461	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355450	08/13/2009					F	11/05/2008	A non-serious, spontaneous report of fever blister on the lip, felt bad and runny nose was received from a nurse concerning an adult female, subsequent to FLUMIST. Neither medical history nor concomitant medications have been reported. The patient received FLUMIST vaccine on 31-Oct-2008. Immediately after receiving FLUMIST, the patient began having a runny nose and just felt bad. Two days later she woke up with a large fever blister on she lip and felt terrible. The following day, she was seen by a doctor, who agreed that her symptoms were caused by FLUMIST. The outcome of the events was not reported.									U	10/31/2008	10/31/2008	0		PUB	UNK	Concomitant Drug(s) Not reported				MEDI0007464	1						1	Malaise; Oral herpes; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355451	08/13/2009	CO	41.0	41		F	11/10/2008	A non-serious, spontaneous report of hives all over her body was received from a nurse, a 41 year-old female subsequent to FluMist. The patient's past medical history includes hives of unknown etiology and trips to the emergency room for IV treatment. Concomitant medications or therapies are unknown. The patient received FluMist , nasal on 04-Nov-2008 for flu vaccination. On the evening of 04-Nov-2009 the patient experienced hives all over her body. The patient went to the emergency room for treatment and received an unknown IV. The patient was not admitted. No additional reactions or descriptions of the reaction were reported of available. The patient recovered from the same night and did not consider the event a big deal.									Y	11/04/2008	11/04/2008	0		PUB	OTH	Not reported		History of hives of unknown etiology with trips to emergency room IV treatment		MEDI0007457	1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355452	08/13/2009	PA	43.0			F	11/07/2008	A non-serious spontaneous report of sore throat, body aches and low grade temperature has been received from a consumer concerning a 43 year-old female, subsequent to FLUMIST. No medical history or concomitant medication information was provided. The patient received FLUMIST on 5-Nov-2008. Less than 24 hours after receiving FLUMIST, the patient reported developing symptoms of sore throat, body aches and low grade temperature. The outcome of these events was not reported. The causality was not reported.									U	11/05/2008	11/05/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007468	1						1	Oropharyngeal pain; Pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355453	08/13/2009	NY	7.0	7		M	11/10/2008	A non-serious spontaneous report of fever has been received from the mother of the patient concerning a seven year-old male, subsequent to FLUMIST. The patient received FLUMIST on 07-Nov-2008. The patient received FLUMIST on a Friday and the mother reported that her son was sick all weekend with a fever up to 103. On 10-Nov-2008 the fever was 101.2. The patietn had not recovered									Y	11/07/2008	11/07/2008	0		OTH	OTH	Concomitant Drug (s): Not reported		None		MEDI0007469	1						1	Malaise; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355454	08/13/2009	VA	17.0	17		F	11/11/2008	A non-serious spontaneous report of headache, chills, and stomach upset has been received from a Doctor of Pharmacy concerning a 17-year-old female subsequent to FLUMIST. Medical history included headaches. The patient was not taking any concomitant medications. On 08-Nov-2008, the patient received FLUMIST, nasal administration for flu immunization. The patient had never received FLUMIST before. On 11-Nov-2008, the patient experienced a severe headache, chills with no fever, and stomach upset. The pharmacist did not know the location or type of headache. The patient was treated with ibuprofen and calcium carbonate. After 12 hours, the patient fully recovered.									Y	11/08/2008	11/11/2008	3		OTH	OTH	Concomitant Drug(s) Not Used		Past Disease: Headache		MEDI0007472	1						1	Abdominal discomfort; Chills; Headache	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355455	08/13/2009	GA				F	11/24/2008	A non-serious spontaneous report of half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician reported that his office received a report of 30 children ages range from five to seven years-old who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following patient demographics and outcome of the event.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007473	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355456	08/13/2009	GA				F	11/24/2008	A non-serious spontaneous report of half the total dose of FLUMIST was received from a physician concerning a female child subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician reported that his office received a report of 30 children ages ranging form five to seven years-old who received half the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug(s) Not reported				MEDI0007475	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355457	08/13/2009	GA				F	11/25/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST.  The patient received FLUMIST on 06-Nov-2008.  A physician from the Centers for Disease Control and Prevention reported that his office received a report of 30 children ages ranged from to seven who received half of the total dose of FLUMIST in one nostril.  The other half was discarded.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007476	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355458	08/13/2009	GA				U	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the agency reported that his office received a report of 30 children ranging in age from five to seven who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007477	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355459	08/13/2009	NC				F	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007478	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355460	08/13/2009	GA				F	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007479	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355461	08/13/2009	GA				F	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. Three was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007480	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355462	08/13/2009	GA				F	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST 06-Nov-2008. A physician reported that his office received a report of 30 children ranging in age from five to seven years who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/06/2008	11/06/2008	0		OTH	OTH					MEDI0007481	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355463	08/13/2009	GA				F	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST.  The patient received FLUMIST on 06-Nov-2008.  A physician from the Centers for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril.  The other half was discarded.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Additional information was received on 24-Nov-2008 that included the following:  demographic data, date of vaccination and confirmation that none of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007482	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355464	08/13/2009	GA				F	11/24/2008	Inappropriate dose of vaccine administered (Incorrect dose administered). A non-serious spontaneous report gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician form CDC reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that one of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant (s) Drugs Not Reported		None		MEDI0007483	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355465	08/13/2009	GA				F	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the agency reported that his office received a report of 30 children ranging in age from five to seven who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007484	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355466	08/13/2009	GA				F	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST.  The patient received FLUMIST on 06-Nov-2008.  A physician from the Centers for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril.  The other half was discarded.  There was no adverse event associated with this medication error;  therefore;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Additional information was received on 24-Nov-2008 that included the following:  demographic data, date of vaccination and confirmation that none of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007485	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355467	08/13/2009	GA				F	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the National Center for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007486	1						1	Incorrect dose administered; Underdose	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355531	08/13/2009	GA				F	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the agency reported that his office received a report of 31 children ranging in age from five to seven who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007487	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355532	08/13/2009	GA				M	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received form a physician concerning a male child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from CDC reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medications error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that one of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported		None		MEDI0007488	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355533	08/13/2009	GA				M	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST.  The patient received FLUMIST on 06-Nov-2008.  A physician from the Centers for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril.  The other half was discarded.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Additional information was received on 24-Nov-2008 that included the following:  demographic data, date of vaccination and confirmation that none of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007489	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355534	08/13/2009	GA				F	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST.  The patient received FLUMIST on 06-Nov-2008.  A physician from the Centers for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril.  The other half was discarded.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Additional information was received on 24-Nov-2008 that included the following:  demographic data, date of vaccination and confirmation that none of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007490	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355535	08/13/2009	GA				M	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the National Center for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007491	1						1	Incorrect dose administered; Underdose	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355536	08/13/2009	GA				M	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST.  The patient received FLUMIST on 06-Nov-2008.  A physician from the Centers for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril.  The other half was discarded.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Additional information was received on 24-Nov-2008 that included the following:  demographic data, date of vaccination and confirmation that none of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007492	1						1	Incorrect dose administered; Underdose	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355537	08/13/2009	GA				M	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the agency reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drugs(s) Not Reported				MEDI0007493	1						1	Incorrect dose administered; Underdose	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355538	08/13/2009	GA				M	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUIST was received from a physician concerning a male child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported		None		MEDI0007494	1						1	Incorrect dose administered; Underdose	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355539	08/13/2009	GA				M	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the National Center for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007495	1						1	Incorrect dose administered; Underdose	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355540	08/13/2009	GA				M	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the National Center for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007496	1						1	Incorrect dose administered; Underdose	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355541	08/13/2009	GA				M	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the National Center for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007497	1						1	Incorrect dose administered; Underdose	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355542	08/13/2009	GA				M	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST.  The patient received FLUMIST on 06-Nov-2008.  A physician from the Centers for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril.  The other half was discarded.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Additional information was received on 24-Nov-2008 that included the following:  demographic data, date of vaccination and confirmation that none of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007498	1						1	Incorrect dose administered; Underdose	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355543	08/13/2009	GA				M	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the National Center for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007502	1						1	Incorrect dose administered; Underdose	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355544	08/13/2009	GA				M	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST.  The patient received FLUMIST on 06-Nov-2008. A physician from CDC reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported		None		MEDI0007503	1						1	Incorrect dose administered; Underdose	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355545	08/13/2009	NV	35.0	35		F	02/27/2009	A non-serious, spontaneous report of gave it unknowingly to a pregnant women in her 3rd trimester was received from a physician concerning a 35 year-old female. The patient's medical history included hypothyroidism, gestational diabetes, asthma and gastroesophageal reflux disease. Concomitant medications include levothyroxine since Feb-2008, glyburide since Nov-2008 and prenatal vitamins since May-2008. (Reference MEDI-0007555). The patient received FLUMIST for flu vaccination on 28-Oct-2008 during her 3rd trimester of pregnancy. The pregnancy was completed 2-Feb-2009 at full term via C-section. There were no complications with delivery and there were no adverse events, congenital anomalies or neonatal illness reported. Additional information was received on 27-Feb-2009 and incorporated into the narrative: pregnancy outcome.									Y	10/28/2008	10/28/2008	0		PVT	OTH	SYNTHROID; Prenatal Vitamins; Glyburide	Asthma	Patient is scheduled to deliver via Cesarean section		MEDI0007511	1						1	Contraindication to vaccination; Drug exposure during pregnancy; Diarrhoea; Drug exposure during pregnancy; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500577P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500577P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0355545	08/13/2009	NV	35.0	35		F	11/25/2008	A non-serious, spontaneous report of vomiting and diarrhea was received from a consumer, concerning a 35 year-old female subsequent to FLUMIST. The patient's past medical history includes asthma, gestational diabetes, hypothyroidism and gastroesophageal reflux disease. The patient is currently in her third trimester of pregnancy with an expected due date of 10-Feb-2009 via caesarean section. Concomitant medications include SYNTHROID since Feb-2008. The patient received FLUMIST, nasal on 28-Oct-2008 for Flu Vaccination. That evening the patient experienced vomiting and diarrhea lasting for five days. The patient recovered from the events.									Y	10/28/2008	10/28/2008	0		PVT	OTH	SYNTHROID	Hypothyroidism; Asthma; Gestational diabetes; Gastroesophageal reflux disease			MEDI0007555	1						2	Contraindication to vaccination; Drug exposure during pregnancy; Diarrhoea; Drug exposure during pregnancy; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500577P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500577P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0355546	08/13/2009	IN	8.0	8		F	11/13/2008	A non-serious spontaneous report of runny nose and sneezing was received from the consumer concerning an eight year-old female, subsequent to FLUMIST.  The patient received FLUMIST on 11-Nov-2008.  The mother of the child reported that on 13-Nov-2008 the child was sent home with a runny nose and sneezing a lot.  The outcome was not reported.									U	11/11/2008	11/13/2008	2		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007517	1						1	Rhinorrhoea; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355547	08/13/2009					F	11/12/2008	A non-serious spontaneous report middle and index finger cuts was received from a nurse concerning an adult female, subsequent to FLUMIST administration.  Neither medical history nor concomitant medications have been reported.  The reporter administered FLUMIST to another person.  As she was placing the syringe into the sharps container, she noticed blood on her hand.  After removing her glove, she found two small but deep cuts on her middle and index fingers that were bleeding.  She inspected the glove and noted three small puncture marks.  She then inspected the syringe and noticed that the finger flange was chipped.  She stated that the only way she could see this happening was due to the product packaging somehow being compressed or jostled enough to cause pressure during transport.  She was not sure if she did any compressing or jostling on the packages either.  The outcome of the event is unknown.									U					UNK	UNK	Concomitant Drug(s) Not Reported				MEDI0007520	1						1	Device breakage; Skin laceration	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355548	08/13/2009	GA				M	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST.  The patient received FLUMIST on 06-Nov-2008. A physician from CDC reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported		None		MEDI0007499	1						1	Incorrect dose administered; Underdose	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355549	08/13/2009	GA				M	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST.  The patient received FLUMIST on 06-Nov-2008.  A physician from the Centers for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril.  The other half was discarded.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Additional information was received on 24-Nov-2008 that included the following:  demographic data, date of vaccination and confirmation that none of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007500	1						1	Incorrect dose administered; Underdose	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355550	08/13/2009	VA	6.0			M	11/17/2008	A non-serious spontaneous report of tested positive for influenza, fever, vomiting and headache was received from a nurse concerning a six year-old male subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 13-Nov-2008. The next day the patient's mother reported the patient experienced fever, vomiting and headache. The child also later tested positive for influenza. The events of fever, vomiting and headache lasted for two days and then resolved.									Y	11/13/2008			Influenza serology, positive	PVT	OTH	None		None		MEDI0007524	1						1	Headache; Influenza; Influenza serology positive; Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500577P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355551	08/13/2009	GA				F	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST.  The patient received FLUMIST on 06-Nov-2008.  A physician from the Centers for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril.  The other half was discarded.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Additional information was received on 24-Nov-2008 that included the following:  demographic data, date of vaccination and confirmation that none of the children experienced adverse events.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007501	1						1	Incorrect dose administered; Underdose	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355552	08/13/2009	MO	39.0			F	11/17/2008	A non-serious, spontaneous report of administration to a pregnant women was received from a consumer, concerning a 39 year-old female.  Neither relevant medical history nor concomitant medications have been reported for this patient.  The patient received FLUMIST on 24-OCT-2008, around the time of conception.  No adverse events have been reported in the patient.  The outcome for the pregnancy is not yet available.									U	10/24/2008	10/24/2008	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0007525	1						1	Contraindication to vaccination; Drug exposure during pregnancy	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355553	08/13/2009	WV	17.0			F	11/18/2008	A non-serious spontaneous report of administration of FLUMIST to a 17-year old pregnant female was received from a nurse practitioner concerning a 17-year old female patient. The patient received a single dose of FLUMIST on 22-Oct-2008. The reporter's clinic was not aware of the pregnancy until 18-Nov-2008. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable.									U	10/22/2008	10/22/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported	Pregnancy			MEDI0007527	1						1	Contraindication to vaccination; Drug exposure during pregnancy	FLUN3~MEDIMMUNE VACCINES, INC.~500553P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355554	08/13/2009	TX	45.0			F	11/20/2008	A non-serious report of head is pounding sinus headache has been received from a consumer concerning a 45 year-old female.  No medical history nor concomitant medications were provided.  The patient received FLUMIST on 18-Nov-2008.  Two hours after the dose of FLUMIST, the patient report head was pounding; feels like a sinus headache that is extreme.  The patient was vaccinated at Air force base.  Outcome for the events was not resolved.									Y	11/18/2008	11/18/2008	0		MIL	OTH	Concomitant Drug(s) Not Reported				MEDI0007535	1						1	Sinus headache	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355555	08/13/2009	UT	5.0	5		F	11/19/2008	A non-serious, spontaneous report of partial dose given was received from a nurse concerning a five year-old female subsequent to FLUMIST. On 19-Nov-2008 the patient received a full dose in one nostril and pulled away during the dose to the second nostril. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.									Y	11/04/2008	11/04/2008	0		PVT	OTH	Concomitant Drug (s) Not Reported				MEDI0007536	1						1	Incorrect dose administered; Underdose	FLUN3~MEDIMMUNE VACCINES, INC.~500547P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355556	08/13/2009	MN	8.0			F	04/09/2009	A non-serious, spontaneous report of accidentally gave expired FLUMIST was received from a physician assistant concerning an eight year-old female subsequent to FLUMIST. The patient received expired FLUMIST on 20-Nov-2008 and was not redosed; the product was expired by eight days. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 04-Dec-2009 that no delayed adverse events resulted from this error. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/20/2008	11/20/2008	0		PVT	OTH	Concomitant Drug (s) Not Reported		None		MEDI0007537	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355557	08/13/2009	GA	10.0			M	12/23/2008	A non-serious report of positive flu nasal swab, high fever, sore throat, cough, body ache, and congestion has been received from a health care professional concerning a 10-year-old male. No medical history nor concomitant medications were provided. The patient received FLUMIST on 17-Nov-2008. One day after the dose of FLUMIST, the patient developed symptoms of high fever, sore throat, cough, body ache, and congestion. The patient was tested positive for flu B via nasal swab. The treating physician prescribed TAMIFLU to the patient. The patient recovered from all of the symptoms. Additional information was received on 23-Dec-2008 and incorporated into the narrative: resolution, provider information, and treatment.									Y	11/17/2008	11/18/2008	1		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0007538	1						1	Cough; Influenza; Oropharyngeal pain; Pain; Pyrexia; Respiratory tract congestion	FLUN3~MEDIMMUNE VACCINES, INC.~500583~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355558	08/13/2009	NC	39.0			M	12/02/2008	A spontaneous non-serious report of single nostril administration was received from a pharmacist concerning a 39 year old male patient. No medical history nor concomitant medications were reported. On 20-Nov-2008, the patient received FLUMIST in a pharmacy which was administered by pharmacist. The clip was off when FLUMIST was administered and the patient received the whole dose in one nostril. He said he felt drainage in the back of the throat. The pharmacist decided to administer another half-dose into the other nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 02-Dec-2008 and incorporated into the narrative. No adverse events occurred after dosing.									Y	11/20/2008	11/20/2008	0		OTH	OTH	None		None		MEDI0007539	1						1	Drug administration error	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355559	08/13/2009	CA	39.0	39		F	12/09/2008	A non-serious spontaneous report of lost sense of smell, feeling rundown, fever, sneezing, nasal congestion and productive cough was received from a consumer concerning a 39 year-old female that occurred two days after receiving FLUMIST. No medical history or concomitant medications were reported. The patient received FLUMIST on 14-Nov-2008. On the 16-Nov-2008, the reporter indicated that she lost her sense of smell and had a mild fever, nasal congestion, productive cough, feeling rundown and sneezing since receiving FLUMIST. Some of the symptoms resolved in 1 to 3 days others are almost resolved. The events of fever, loss of smell and productive cough resolved; sneezing, feels rundown and nasal congestion were almost resolved as of 26-Nov-2008. The reporter states that she has acquaintances who experienced similar symptoms around the same time period of her symptoms; she thinks she had a cold.										11/14/2008	11/16/2008	2		OTH	PVT	None		None		MEDI0007541	1						1	Anosmia; Malaise; Nasal congestion; Nasopharyngitis; Productive cough; Pyrexia; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355560	08/13/2009	VA	6.0	6		F	04/09/2009	A non-serious spontaneous report of expired FLUMIST administered was received from a nurse concerning a six-year-old female. No medical history was provided. A nurse gave the patient FLUMIST that expired on 12-Nov-2008. There was no adverse event associated with this medication error therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow up received on 02-Dec-2008 includes: patient was not re-dosed and no adverse events occurred. Additional information was received on 09-Apr-2009: Based on the results for the investigation, the root cause for the medication errors were caused by 1)customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.									Y	11/14/2008	11/14/2008	0		PUB	PUB	Concomitant Drug (s) Not Reported				MEDI0007531	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355561	08/13/2009	NV	57.0			F		A non-serious spontaneous report of administration to a 57 year old was received from a pharmacist concerning a 57-year-old female. The pharmacist accidentally administered FLUMIST to the patient. There was no adverse event associated with this medication error at the time of the report, nor on 19-Nov-2008; therefore, treatment and reporter/sponsor causality assessments are no applicable, and the event is considered resolved.									Y	11/19/2008	11/19/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007544	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355563	08/13/2009	CT	10.0			F	04/09/2009	A non-serious spontaneous report of administered expired FLUMIST was received from a nurse concerning a ten-year-old female. The patient received FLUMIST on 02-Dec-2008 The patient was given FLUMIST that expired in December 2007. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1)customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication error that occurred shortly after the product expired. Additional information received on 09-Apr-2009: product complaint investigation results.									Y	12/02/2008	12/02/2008	0		PVT	OTH	Concomitant Drug (s) Not Reported				MEDI0007580	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500490P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355564	08/13/2009	TX	31.0	31		F	12/22/2008	A non-serious report  of administration of half dose of FLUMIST was received from a consumer concerning a 31-year-old female.  No medical history was reported.  There was no adverse event associated with this medication error at the time of report, nor when follow-up was obtained;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Additional information received 22-Dec-2008 and incorporated into the case:  No adverse event occurred and patient demographic information added.									Y	11/19/2008	11/19/2008	0		PVT	PVT	Concomitant Drug(s) Not Reported				MEDI0007549	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~500584P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355565	08/13/2009	MD	19.0	19		M	12/03/2008	A non-serious, spontaneous report of root canal, ear infection, sinus infection and nasal congestion was received from a nurse/parent, concerning a 19 year-old male subsequent to FLUMIST.  The patient's past medical history includes IgG two deficiency, asthma, otitis infections and skin granuloma.  No concomitant medications have been reported for this patient.  The patient received a first dose of FLUMIST, intranasal for flu vaccination on 24-Oct-2008.  On 26-Oct-2008 the patient experienced nasal congestion which progressed to a sinus infection on 31-Oct-2008.  The patient was seen by a dentist on 01-Nov-2008 and was given AMOXICILLIN 500 mg for one week.  On 19-Nov-2008 the patient experienced ear infection and was given AMOXICILLIN/clavulanic acid combination 875 mg for one week.  The patient recovered from the nasal congestion, sinus infection and ear infection on 26-Nov-2008.  The patient recovered from the root canal procedure on 13-Nov-2008.									Y	10/24/2008	10/26/2008	2		PVT	OTH	Concomitant Drug(s) Not Used	Allergy;  Asthma;  Skin granuloma	IgG2 deficiency;  Otitis infections		MEDI0007581	1						1	Ear infection; Endodontic procedure; Nasal congestion; Sinusitis	FLUN3~MEDIMMUNE VACCINES, INC.~500544P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355566	08/13/2009	NY	10.0			F	11/25/2008	A spontaneous non-serious report of burning the nostril, hurting and administered of half dose has been received from a nurse practitioner concerning a 10 year old female patient subsequent to FLUMIST. Medical history and concomitant medications were not reported. On 19-Nov-2008, the patient received one-half dose of FLUMIST in one nostril. During the administration of FLUMIST, the patient complained of the vaccine burning the nostril and burning. The patient was not able to tolerate administration in the other nostril; therefore, the patient only received a half dose of FLUMIST. At the time of the report, the patient had no symptoms. The events of burning the nostril and hurting were recovered/resolved on an unspecified date in Nov-2008.									Y	11/19/2008	11/19/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007552	1						1	Nasal discomfort; Underdose	FLUN3~MEDIMMUNE VACCINES, INC.~500558P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355567	08/13/2009	OH	10.0	10		F	01/08/2009	A non-serious spontaneous report of arthralgia has been received from a health care worker concerning a 10 year-old female, subsequent to receiving FLUMIST.  The patient's past history includes experiencing right arm pain one month after her 2007 FLUMIST dose.  No concomitant medications were reported.  The patient received FLUMIST on 18-Oct-2008, nasally for influenza prevention.  On 19-Nov-2008, the patient came to her physician's office unable to walk complaining of severe right ankle pain.  The patient was referred to an Infectious Disease (ID) specialist, due to the similar event that occurred the previous year.  The ID specialist diagnosed the event as arthralgia and was unable to determine the etiology of the event.  The event was treated with ADVIL.  The ankle pain resolved on 28-Nov-2008 at which time the patient's mother stated the patient was without fever and pain;  she was doing well and walking fine.  The site indicated they will discontinue dosing the child with FLUMIST.  The patient experienced a similar adverse reaction in 2007 one month after receiving FLUMIST.  Follow up was received on 08-Jan-2009 and incorporated into the above narrative.  Diagnosis obtained and date of resolution.									Y	10/18/2008	11/19/2008	32	A scheduled MRI was cancelled.	PVT	PVT	Concomitant Drug(s) Not Reported		Experienced right arm pain after the 2007 dose of FLUMIST.		MEDI0007582	1						1	Arthralgia; Gait disturbance	FLUN3~MEDIMMUNE VACCINES, INC.~500541P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355568	08/13/2009	OH	9.0	9		F	12/02/2008	A non-serious unlabeled spontaneous report of right arm pain has been received from a health care worker concerning a nine-year-old female, subsequent to receiving FLUMIST. No past medical history or concomitant medications were reported. The patient received FLUMIST on 21-Nov-2007, nasally for influenza prevention. On 20-Dec-2007, the patient came to her physician's office with right arm pain so severe she would not allow anyone to touch her. The patient was referred to Orthopedic and neurology specialists; she was treated with orapred for 5 days, diphenhydramine, TYLENOL no. 3 and ALEVE. Around the same period of time the patient had a dodge ball injury in gym and her arm pain was attributed to the gym injury. The arm pain resolved on an unknown date.									Y	11/21/2007	12/20/2007	29		PVT	PVT	Concomitant Drug (s) Not Reported				MEDI0007583	1						1	Pain in extremity; Sports injury	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355569	08/13/2009	KY	7.0			M	12/03/2008	A non-serious spontaneous report of full dose of FLUMIST in one nostril has been received from a registered nurse concerning a seven year-old male. The patient received FLUMIST on 02-DEC-2008. The reporter stated that the patient received a full dose of FLUMIST in one nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	12/02/2008	12/02/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007584	1						1	Vaccination error	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355570	08/13/2009	WI	52.0			F	12/03/2008	A non-serious spontaneous report of was received from a nurse concerning a 52-year old female. Information on FLUMIST use in ages 50 to 64 years of age was requested. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y					OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007587	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355571	08/13/2009	CA	34.0			F	11/25/2008	A spontaneous non-serious report of pregnancy was received from a nurse practitioner concerning a 34 year old female patient.  The mother of one of their patients was in the office and indicated that she, the mother, had received FLUMIST two weeks earlier and just found out the she was pregnant.  The mother experienced no difficulty at the time of the report.  There was no adverse event associated with this pregnancy.  Treatment and reporter/sponsor causality assessments are not applicable.  The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during this pregnancy.									U	11/10/2008	11/10/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported		11/2008:  Pregnancy confirmed 2 weeks after FLUMIST dose		MEDI0007554	1						1	Drug exposure during pregnancy	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355573	08/13/2009	IA	12.0	12		F	04/09/2009	A non-serious spontaneous report of administered expired FLUMIST has been received from a nurse concerning a 12-year- old female. The patient's medical history included sinus problems; the patient was not taking any concomitant medications. On 04-Dec-2008, a certified medical assistant (CMA) in a community health inadvertently administered expired FLUMIST; the product was expired by nine days. The patient came into the clinic for sinus problems and the physician recommended the vaccine. Per the reporter, the CMA who administered the vaccine did not foll0w their internal clinic procedures. No adverse events have been reported since the vaccine error. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 19-Dec-2009 that no delayed adverse events resulted from this error. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	12/04/2008	12/04/2008	0		PUB	PVT	Concomitant Drug (s) Not Reported				MEDI0007593	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355574	08/13/2009	KY	55.0			M	12/08/2008	A spontaneous non-serious report of inadvertently administered FLUMIST to a 55 year old male has been received from a nurse.  Medical history and concomitant medications were not reported.  On 05-Dec-2008, the patient received FLUMIST.  Shortly after the nurse administered FLUMIST, she discovered that the drug was not approved for the patient's age group.  The patient did not experience any apparent changes in medical/health status.  There was no adverse event associated with this medication error, therefore;  treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	12/05/2008	12/05/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007598	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355575	08/13/2009	VT	10.0			F	11/26/2008	A non-serious report of fever, vomiting, chills, sore throat, and runny nose has been received from a nurse concerning a 10-year-old female, subsequent to FLUMIST. No medical history nor concomitant medications were provided. The patient received FLUMIST on 25-Nov-2008. On the next morning, the patient woke up with symptoms of fever, vomiting, chills, sore throat, and runny nose. Outcome for the events not reported.									U	11/25/2008	11/26/2008	1		PUB	PUB	Concomitant Drug(s) Not Reported				MEDI0007559	1						1	Chills; Oropharyngeal pain; Pyrexia; Rhinorrhoea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500561P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355576	08/13/2009	WI	48.0	48		F	11/26/2008	A non-serious spontaneous report of bright red rash has been received from a nurse concerning a 48 year old female, subsequent to receiving FLUMIST.  No medical history or concomitant medication information was provided.  The patient received FLUMIST on 25-Nov-2008 nasally.  Within 4 to 6 hours after receiving FLUMIST, the patient noticed two bright red spots on her face, both on the right cheek.  One spot is 1/2 inch in diameter the other is 1 inch in diameter and the spots do not itch.  The patient reported the rash resolved by 01-Dec-2008.									Y	11/25/2008	11/25/2008	0		PUB	PUB	Concomitant Drug(s) Not Reported				MEDI0007562	1						1	Rash erythematous	FLUN3~MEDIMMUNE VACCINES, INC.~500545P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355577	08/13/2009	MD	46.0			U	04/09/2009	A non-serious spontaneous report of administered expired FLUMIST has been received from a nurse concerning a 46-year-old of unknown gender. No medical history nor concomitant medications were provided. On 26-Nov-2008, the county health department inadvertently administered expired FLUMIST to 10 patients (ages 3 to 46). The product was expired by one day. The patients did not experience any adverse events and will be revaccinated in four weeks. There was no adverse event associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 09-Apr-2009: product complaint investigation results.									Y	11/26/2008	11/26/2008	0		PUB	PUB	Concomitant Drug(s) Not Reported				MEDI0007564	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500543P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355578	08/13/2009	NC				M	11/24/2008	A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the agency reported that his office received a report of 30 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/06/2008	11/06/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007585	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355579	08/13/2009	TX	12.0	12		F	11/29/2008	Neither relevant medical history nor concomitant medications were reported for this patient. The patient received FLUMIST on 28-Nov-2008, intranasal for Flu vaccination. Approximately twelve hours following administration, on 29-Nov-2008 the patient vomited twice and experienced muscle aches. The patient recovered from the episode of vomiting on 29-Nov-2008 and recovered from the muscle aches on 30-Nov-2008. The patient's physician told the parent she did not think the events were related to FLUMIST.									Y	11/28/2008	11/29/2008	1		PVT	OTH	Concomitant Drug(s) Not Used				MEDI0007566	1						1	Myalgia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355580	08/13/2009	TX	9.0	9		F	11/29/2008	A non-serious, spontaneous, report of vomiting, nausea and diarrhea was received from a consumer, concerning a nine-year-old female subsequent to FLUMIST. The patients medical history includes sensitive stomach with vomiting, and seasonal and nasal allergies. Concomitant medications include fluticasone propionate since Nov-2007 for nasal allergies. The patient received FLUMIST on 28-Nov-2008, intranasal for influenza vaccination. Approximately six hours following administration, the patient experienced nausea and began vomiting about every 20 minutes throughout the night. The next day, the patient experienced diarrhea and was taken to the pediatrician office because she could not hold down water. She was given a PEDIALYTE pop and PHENERGAN by mouth. The patient recovered from the events on 29-Nov-2008. The patient's physician told the parent she did not think the events were related to FLUMIST.									Y	11/28/2008	11/28/2008	0		PVT	OTH	FLONASE	Seasonal allergy	Sensitive stomach with vomiting; nasal allergies;		MEDI0007567	1						1	Diarrhoea; Nausea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355581	08/13/2009	IA	42.0			M	03/31/2009	A non-serious spontaneous report of administered expired FLUMIST has been received from a nurse concerning a 42-year old male.  The patient's medical history and concomitant medications were not reported.  On 05-Dec-2008, the patient was inadvertently administered expired FLUMIST;  the product was expired by 10 months (February 2008).  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Additional information was received on 31-Mar-2009 that included the results of a Lot Investigation. Eased on the results of the investigation, the root for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.									Y	12/05/2008	12/05/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007603	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500496P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355582	08/13/2009	NY	6.0			F	12/08/2008	A spontaneous non-serious report of scabies was received form a nurse concerning a six year old female patient subsequent to FLUMIST. Medical history and concomitant medications were not reported. On 18-Nov-2008 the patient received FLUMIST. On 27-Nov-2008, nine days after receiving FLUMIST, the mother took the patient and her brother, who also received FLUMIST, to the emergency room (ER) with rash on their arms and body that started on or shortly after the day the patient received FLUMIST. Treatment included BENADRYL, and acyclovir. The attending physician in the ER  diagnosed the patient with scabies and not an allergic reaction. At the time of the report, the event of scabies was ongoing and may be worsening.									N	11/18/2008	11/18/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007605	1						1	Acarodermatitis	FLUN3~MEDIMMUNE VACCINES, INC.~500553P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355583	08/13/2009	NY	9.0			M	12/08/2008	A spontaneous non-serious report of scabies was received from a nurse concerning a nine year old male patient subsequent to FLUMIST. Medical history and concomitant medications were not reported. On 18-Nov-2008 the patient received FLUMIST. On 27-Nov-2008, nine days after receiving FLUMIST, the mother took the patient and his sister, who also receive FLUMIST, to the emergency room (ER) with rash on their arms and body that started on or shortly after the day the patient received FLUMIST. Treatment included BENADRYL and acyclovir. The attending physician in the ER diagnosed the patient with scabies and not an allergic reaction. At the time of the report, the event of scabies was ongoing and may be worsening.									Y	11/18/2008	11/18/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007606	1						1	Acarodermatitis; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355584	08/13/2009	IN	6.0	6		M	12/10/2008	A non-serious spontaneous report of Henoch-Schoenlein purpura and upper respiratory infection was received from a physician concerning a 6 year-old male, subsequent to receiving FLUMIST.  At the time of FLUMIST administration the patient had a mild skin rash that the physician diagnosed as a fungal infection.  No concomitant medications were reported.  The patient received FLUMIST on 26-Nov-2008.  Around 01-Dec-2008 the patient experienced a mild upper respiratory infection that was resolving on 04-Dec-2008 at the time the patient was seen due to Henoch-Schoenlein purpura (HSP).  No treatment was given for the HSP, the patient was monitored.  The HSP resolved later in Dec-2008.									Y	11/26/2008	12/01/2008	5		PVT	PVT	Concomitant Drug(s) Not Reported	Fungal infection	At the time he received FLUMIST the patient had mild skin rash that was diagnosed as a fungal infection.		MEDI0007611	1						1	Henoch-Schonlein purpura; Upper respiratory tract infection	FLUN3~MEDIMMUNE VACCINES, INC.~500585P~1~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355585	08/13/2009	TX	9.0			U	12/01/2008	A non-serious spontaneous report of vomiting was received from a consumer concerning a nine year-old (gender not reported), subsequent to FLUMIST. The patient received FLUMIST on 29-Nov-2008. The mother of the child stated that 6 to 12 hours after administration of FLUMIST the child started to vomit. The outcome of the vomiting was not reported.									U	11/28/2008	11/28/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007572	1						1	Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355586	08/13/2009	CA	7.0	7		M	01/05/2009	A non-serious spontaneous report of administration of expired product has been received from a Registered Nurse concerning a seven-year-old male who received FLUMIST on 15-Nov-2008. FLUMIST expired on 12-Nov-2008. Medical history and concomitant medications were not reported. There was no adverse event reported with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. On 05-Jan-2009, the reporting nurse confirmed that there were no late-occurring adverse events reported.									Y	11/15/2008	11/15/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007615	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355587	08/13/2009	MI	54.0			F	12/10/2008	A non-serious, spontaneous report of gave FLUMIST to a 54 year-old was received from a pharmacist, concerning a 54 year-old female subsequent to FLUMIST. There was no adverse even associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.									Y	12/10/2008	12/10/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007620	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355588	08/13/2009	PA	5.0			F	12/12/2008	A spontaneous non-serious report of coughing and hives has been received from a patient's father concerning a five year old female patient subsequent to FLUMIST. The patient has no relevant medical history and no concomitant medications. On an unknown date in October 2008, the patient received FLUMIST. The patient received FLUMIST and started coughing immediately after administration. A day or two after dosing, the patient broke out in hives. She was referred to an allergist, who treated her with medication with steroid. A skin test was not performed; it was though that she may be allergic to red dye #3. She continued to take oral BENADRYL every morning; however, one day she did not take BENADRYL, her hives broke out. The patient's father had not taken the patient to a physician for further follow-up; the family was looking for a new allergist. As of 12-Dec-2008, she continued to break out in hives, which resolved with BENADRYL. The patient's cough was ongoing. Additional information was received on 12-Dec-2008 and incorporated into the narrative: medical history, siblings, event details and outcome.									N					PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0007576	1						1	Cough; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355589	08/13/2009	PA	26.0	26		F	04/21/2009	A non-serious spontaneous report of FLUMIST given to a pregnant female has been received from a Registered Nurse concerning a 26-year-old female. Medical history included asthma, smoking, bipolar disorder and allergies to codeine and aspirin. Obstetrical history included eight previous pregnancies (four full-term deliveries, three spontaneous abortions and one delivery of twins at 24 weeks, the twins died shortly after birth). The patient continued to smoke throughout this pregnancy. Concomitant therapy included albuterol and prenatal vitamins. The father's medical history included borderline retardation/was slightly retarded'> On 02-Oct-2008, the patient received FLUMIST at a county health department. When filling out her paperwork to receive FLUMIST, she indicated that she was not pregnant. The patient's obstetrician/gynecologist contacted the reporting nurse to indicate that the patient was pregnant. Gestation at the time of exposure was 13 weeks. Last menstrual period was 13-Jun-2008 and the patient's estimated date of delivery was 24-Mar-2009. On 26-Mar-2009, the patient gave birth to a normal baby boy (eight pounds, one ounce; 19.25 inches) via vaginal birth at 40+ weeks gestation. Apgar scores at one minute was nine and at five minutes was nine. The patient had no complications during her pregnancy and no complications with the delivery. There were no adverse events reported. Additional information received on 11-Dec-2008 was incorporated into the narrative and included patient demographics, vaccine information, medical history, concomitant medications and pregnancy information. Additional information received on 21-Apr-2009 and incorporated into the narrative included the outcome of the pregnancy and the labor and delivery summary.									Y	10/02/2008	10/02/2008	0		PUB	PUB	Prenatal vitamin; Albuterol	Asthma	Gravida 9, terms births 4, premature births 1 (set of twins born at 24 weeks gestation that died shortly after birth), spontaneous abortions 3, living children 4; allergies to codeine and aspirin		MEDI0007578	1						1	Drug exposure during pregnancy	FLUN3~MEDIMMUNE VACCINES, INC.~500547P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355596	08/13/2009	MO	49.0	49		F	04/09/2009	A non-serious spontaneous report of expired FLUMIST given was received from a registered nurse concerning a 49 year-old female, It was discovered 21 days after dosing that the patient was given expired FLUMIST. The reporter indicated the FLUMIST expired at the beginning of the flu season. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from error that occurred shortly after the product expired. Additional information received on 09-Apr-2009: product complaint investigation results.									Y	11/20/2008	11/20/2008	0		PVT	PVT	Concomitant Drug (s) Not Reported		No medical history obtained.		MEDI0007621	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355598	08/13/2009	OH	6.0			F	12/15/2008	A spontaneous non-serious report of glassy looking eyes, red eyes, eye discharge and nasal congestion has been received from a consumer concerning a six year old female patient subsequent to FLUMIST.  Medical history and concomitant medications were not reported.  On 11-Dec-2008, the patient received FLUMIST.  Within 24 hours of administration, the patient developed nasal congestion which progressed to glassy looking eyes, red eyes and discharge from eyes.  These symptoms were not associated with itching or burning of the eyes.  The patient's mother was going to take her to the doctor's office;  however, the symptoms began to clear on 14-Dec-2008 with no discharge and only mild redness of the eyes.  The events of glassy looking eyes, red eyes, discharge and nasal congestion from eyes was recovering/resolving.									Y	12/11/2008	12/12/2008	1		PUB	OTH	Concomitant Drug(s) Not Reported				MEDI0007629	1						1	Eye discharge; Eye disorder; Nasal congestion; Ocular hyperaemia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355599	08/13/2009	NV	22.0	22		F	12/29/2008	A non-serious spontaneous report of FLUMIST sprayed in the eye was received from a registered pharmacist concerning a 22-year-old female.  Medical history and concomitant medications were not reported.  On 13-Dec-2008, the patient received FLUMIST.  FLUMIST was sprayed in the eye during administration.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessment are not applicable, and the event is considered resolved.  Additional information received on 29-Dec-2008 was incorporated into the narrative and included the patient's gender and the lot number of FLUMIST.  The pharmacist confirmed that there were no late-occurring adverse events reported.									Y	12/13/2008	12/13/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007630	1						1	Accidental exposure	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355600	08/13/2009	MD	23.0	23		F	12/24/2008	Vaccine exposure during pregnancy. A spontaneous non-serious report of administration to pregnant female was received from a nurse concerning a 23 year old female patient. On 30-Sep-2008, FLUMIST was administered to the patient at the health department. The patient was two to three weeks pregnant. In November 2008, the patient discovered she was pregnant. She had no symptoms or problems at the time of the report. There was no adverse event associated with this FLUMIST exposure to a pregnant female. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient/subject experiences any adverse events during the pregnancy.									U	09/30/2008	09/30/2008	0		PUB	OTH	Concomitant Drug(s) Not Reported				MEDI0007670	1						1	Contraindication to vaccination; Drug exposure during pregnancy	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355601	08/13/2009	MI	6.0			M	04/09/2009	A non-serious, spontaneous report of administration of expired product was received from a registered nurse concerning a 6-year 11 month old male. Neither medical history nor concomitant medications were reported. On 29-Dec-2008, two siblings, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of 23-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 10-Mar-2009. The reporter confirmed that no delayed adverse events resulted from this error. Additional information was received on 09-Apr-2009: product complaint investigation results.									Y	12/29/2008	12/29/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007671	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500550P`~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355602	08/13/2009	IN	55.0	55		M	01/13/2009	A non-serious spontaneous report of hives, red blotchy skin/redness, both hands swelled and 55-year-old administered FLUMIST has been received from the patient, as 55-year-old male. The patient had no relevant medical history nor concomitant medications. On 08-Oct-2008, the patient received FLUMIST via intranasal administration as a flu vaccine. Within 18 hours on that date, the patient developed hives on his buttocks and ribs and both hands swelled (not his feet). This peaked at 24 hours then diminished in the next 24 hours. At that time, he had just red blotchy skin/redness where the hives were. The patient did not see a physician. He self-treated with fexofenadine hydrochloride 24 hours after his FLUMIST dose. On 11-Oct-2008, the patient recovered. Additional information received on 13-Jan-2009 and incorporate into the above narrative included therapy dates, treatment medications, additional events and outcome dates.									Y	10/08/2008	10/08/2008	0		OTH	OTH	Concomitant Drug(s) Not Used				MEDI0007632	1						1	Oedema peripheral; Rash erythematous; Rash macular; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355603	08/13/2009	MI				F	04/09/2009	A non-serious spontaneous report of administration of expired product has been received from a Registered Nurse concerning a female employee in her 20's who received FluMist.  Medical history and concomitant medications were not reported.  On 15-Dec-2008, the patient was administered FLUMIST which expired on 12-Nov-2008.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information received on 29-Dec-2008 and incorporated into the narrative included patient demographics and lot number of FLUMIST.  The reporter confirmed there were no late-occurring adverse events.  Follow-up information was received on 09-Apr-2009:  Product Complaint Investigation results.									Y	12/15/2008	12/15/2008	0		PUB	OTH	Concomitant Drug(s) Not Reported				MEDI0007676	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355604	08/13/2009	CA	6.0			F	04/09/2009	A non-serious spontaneous report of administration of expired product has been received from a Registered Nurse concerning a 6 year old female who received FLUMIST. Medical history and concomitant medications were not reported. On 16-Dec-2008, this child was administered FLUMIST which expired on 15-Dec-2008. There was no adverse event associated with this error; therefore; treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 09-Apr-2009 that included the results of an investigation of into the cause of medication error.									Y	12/16/2008	12/16/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007635	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355605	08/13/2009	MI				F	04/09/2009	A non-serious spontaneous report of administration of expired product has been received from a Registered Nurse concerning a female employee in her 20's who received FLUMIST. Medical history and concomitant medications were not reported. On 15-Dec-2008, the patient was administered FLUMIST which expired on 12-Nov-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were cased by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 29-Dec-2008 and incorporated into the narrative included patient demographics and lot number of FLUMIST. The reporter confirmed there were no late-occurring adverse events. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	12/15/2008	12/15/2008	0		PUB	OTH	Concomitant Drug(s) Not Reported				MEDI0007677	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355606	08/13/2009	MI	24.0	24		F	12/18/2008	A non-serious spontaneous report of administration to a pregnant female was received from a consumer concerning a 24-year-old female. The patient's medical history and concomitant medications were not reported. The patient was administered FLUMIST but did not know that she was pregnant. There was no adverse event reported to date. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.									U	11/12/2008	11/12/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007642	1						1	Contraindication to vaccination; Drug exposure during pregnancy	FLUN3~MEDIMMUNE VACCINES, INC.~500544P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355607	08/13/2009	MD	5.0			M	12/17/2008	A spontaneous non-serious report of administration of extra dose has been received from a nurse practitioner concerning a five year old male patient subsequent to FLUMIST. Medical history and concomitant medications were not reported. On 15-Dec-2008, the patient received one dose of FLUMIST and on 17-Dec-2008, the patient received FLUMIST again. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	12/15/2008	12/17/2008	2		PUB	PUB	Concomitant Drug(s) Not Reported				MEDI0007644	1						1	Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355608	08/13/2009	MI	28.0	28		F	12/18/2008	A spontaneous non-serious report of administration to pregnant female has been received from a health care professional concerning 28 year old female subsequent to FLUMIST. Medical history and concomitant medications were not reported. No obstetrical history was available. On 07-Nov-2008, the patient received FLUMIST and subsequently discovered she was pregnant. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.									U	11/07/2008	11/07/2008	0		OTH	OTH	Concomitant Drug(s) Not reported				MEDI0007645	1						1	Contraindication to vaccination; Drug exposure during pregnancy	FLUN3~MEDIMMUNE VACCINES, INC.~500544P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355609	08/13/2009	MI				F	04/09/2009	A non-serious spontaneous report of administration of expired product has been received from a Registered Nurse concerning a female employee in her 20's who received FLUMIST. Medical history and concomitant medications were not reported. On 15-Dec-2008, the patient was administered FLUMIST which expired on 12-Nov-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 29-Dec-2008 and incorporated into the narrative included patient demographics and lot number of FLUMIST. The reporter confirmed there were no late-occurring adverse events. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	12/15/2008	12/15/2008	0		PUB	OTH	Concomitant Drug(s) Not Reported				MEDI0007657	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355610	08/13/2009	MI	6.0			F	03/27/2009	A non-serious spontaneous report of expired FLUMIST given to this patient was received from a certified medical assistant concerning a six-year-old female. Neither medical history nor concomitant medications were reported. On 26-Dec-2008, the patient and her brother received expired FLUMIST vaccine. The vaccine had an expiration date of 25-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 03-Feb: reporter confirmed no delayed occurring adverse events related to being given expired FLUMIST. Follow-up information received on 27-Mar-2009 included Product Complaint Investigative results. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customer not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication error that occurred shortly after the product expired.									Y	12/26/2008	12/26/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported		Sibling also received expired FLUMIST		MEDI0007687	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~5000551P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355611	08/13/2009	KY	52.0			F	04/09/2009	A non-serious spontaneous report of administration of expired product to a 52-year-old was received from a Nurse concerning a 52-year-old female. The patient's medical history and concomitant medications were not reported. On 22-Dec-2008, the patient received expired FLUMIST (expiration date 21-Dec-2008). The reporter inquired about dosing with expired product and information in patient over 49 years of age. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	11/22/2008	11/22/2008	0		PVT	PVT	Concomitant Drug(s) Not Reported				MEDI0007661	1						1	Expired drug administered; Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500557P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355612	08/13/2009	WI	14.0			M	04/09/2009	A non-serious spontaneous report of administered expired FLUMIST was received from a Registered Nurse concerning a 14 year-old-male. FLUMIST, which expired on 25-Dec-2008, was administered on 29-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	12/29/2008	12/29/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007689	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500551~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355613	08/13/2009	WA	11.0	11		M	04/09/2009	A non-serious spontaneous report of gave expired FLUMIST to an 11-year old was received from a Nurse Manager concerning a 11-year-old male. The patient's medical history and concomitant medications were not available. On 29-Dec-2008, the patient received expired FLUMIST (expiration date 24-Dec-2008) at an immunization clinic. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 07-Jan-2009 that no delayed adverse events resulted from this error. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	12/29/2008	12/29/2008	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0007690	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500559P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355614	08/13/2009	WV	7.0	7		M	03/20/2009	A non-serious report of administered expired FLUMIST was received from a Registered Nurse concerning a seven-year-old male.  Medical history and concomitant medications were not reported.  On 22-Dec-2008, the patient received FLUMIST that expired on 10-Dec-2008.  The physician decided not to redose with FLUMIST.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  On 08-Jan-2009, the reporting nurse confirmed that there were no late-occurring adverse events.  Follow-up information received on 20-Mar-2009 included Product Complaint Investigation results.									Y	12/22/2008	12/22/2008	0		OTH	OTH	Concomitant Drug(s):  Not Reported				MEDI0007663	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500545P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355615	08/13/2009	RI	9.0			M	04/09/2009	A non-serious, spontaneous report of gave expired FLUMIST was received from a registered nurse concerning a nine-year-old male subsequent to FLUMIST therapy. On 29-Dec-2008, the patient received expired FLUMIST, which had an expiration date of 28-Dec-2008. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Subsequent contact with the initial reporter on 13-Jan-2009 confirmed no adverse event occurrence. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received 09-Apr-2009: product complaint investigation results.									Y	12/29/2008	12/29/2008	0		PVT	OTH	Concomitant Drug (s) Not Reported		None		MEDI0007693	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355616	08/13/2009	AZ	14.0			M	03/13/2009	A spontaneous non-serious report of administration of expired product has been received from a nurse practitioner concerning a 14 year old male patient subsequent to FLUMIST. Medical history and concomitant medication were not reported. On 23-Dec-2008, the patient received FLUMIST that expired on 21-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information received on 31-Mar-2009: Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.									Y	12/23/2008	12/23/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007665	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500557P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355617	08/13/2009	MN	15.0			M	04/09/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a registered nurse concerning a 15-year-old male. Neither medical history nor concomitant medications were reported. On 22-Dec-2008, two siblings, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of 16-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customer not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication error that occurred shortly after the product expired. Additional information was received on 09-Mar-2009 that no delayed adverse events resulted from this error.									Y	12/22/2008	12/22/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007668	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500547P~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355618	08/13/2009	TX	15.0			M	03/20/2009	A non-serious spontaneous report of administration of one-half dose of expired product was received from a certified medical assistant concerning a 15-year-old male subsequent to FLUMIST. Neither medical history nor concomitant medications were reported. On 30-Dec-2008, the reporter administered one-half of FLUMIST dosage when she noticed that the product had expiration date of 26-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 20-Mar-2009: Investigation lot analysis results. Follow-up information was received on 04-May-2009: confirmation that the patient did not experience any adverse events.									Y	12/30/2008	12/30/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007694	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~5005527P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355619	08/13/2009	CT	13.0	13		F	04/09/2009	A non-serious spontaneous report of expired FLUMIST administered was received from a registered nurse concerning a 13-year-old female. The child was administered a FLUMIST dose that had expired 12 days earlier.  There was no adverse event associated with this inadvertent administration of expired FLUMIST; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding products from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 15-Jan-2009 includes: DOB, FLUMIST information and no late adverse events were reported. Additional information was received on 09-Apr-2009: product Complaint Investigation results.									Y	12/30/2008	12/30/2008	0		PVT	PUB	Concomitant Drug(s) Not Reported				MEDI0007695	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500548P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355620	08/13/2009	MN	17.0			F	04/09/2009	A non-serious report of expired FLUMIST administered was received from a registered nurse concerning a 17-year-old female. Neither medical history nor concomitant medications were reported. On 22-Dec-2008, two siblings, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of December 16, 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 09-Mar-2009 that no delayed adverse events resulted from this error. Additional information was received on 09-Apr-2009: product complaint investigation results.									Y	12/22/2008	12/22/2008	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007669	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500547P~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355622	08/13/2009	AL	9.0	9		F	01/05/2009	A spontaneous non-serious report of hives, itching, leg pain, bruising and attention deficit/hyperactivity disorder (ADHD) has been received from manufacturer (manufacturer control number 08P-163-0479239-00) concerning a nine-year old female patient subsequent to FLUMIST use. The original reporter was a physician. Medical history included precocious puberty and no known allergies. Suspect medication included leuprolide acetate depot. Concomitant medications obetrol (ADDERALL and ADDERALL XR) 20 mg. On 24-Sep-2008, the patient received FLUMIST for flu vaccination and then her monthly dose of leuprolide acetate depot. Five minutes after receiving leuprolide acetate depot injection, the patient developed hives, itching, pain in entire leg and bruising. The bruising described as multiple red and deep purple blotches, did not originate at the site of the injection. It covered the patient's entire thigh, from top to the knee. Treatment with diphenhydramine was started for the hives and itching. On 01-Oct-2008, leuprolide acetate depot was discontinued. the patient's mother was advised to continue treatment with diphenhydramine until the reactions resolved. The events of hives, itching and bruising were resolving. The event of pain was resolved. The outcome of ADHD was unknown. The physician assessed the events of hives, itching, pain in entire leg and bruising as possibly related to leuprolide acetate depot, but the causality was questionable since the patient had been on leuprolide acetate depot since 2005. FLUMIST was also considered suspect.									U	09/24/2008	09/24/2008	0		OTH	OTH	ADDERAL and  ADDERALLL XR, 20 mg	Precocious puberty	No known allergies.		MEDI0007707	1						1	Attention deficit/hyperactivity disorder; Contusion; Pain in extremity; Pruritus; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355623	08/13/2009	TX	19.0			F	03/31/2009	A non-serious spontaneous report of 29 patients ( 26 children & 3 adults) received expired FLUMIST was received from a physician concerning a 19-year-old female. The patient's medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customer not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 05-Feb-2009 and incorporated into the narrative: gender and age; confirmation that there were no adverse events. Additional information received on 04/09/2009 included Product Complaint Investigative results.									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug(s) Not Reported				MEDI0007709	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355625	08/13/2009	MO	29.0	29		M	04/09/2009	A non-serious report of expired FLUMIST given was received from a registered nurse concerning a 29-year-old male.  On 04-Dec-2008, the patient was administered expired FLUMIST (12-Nov-2008);  the product was expired by 22 days.  The reporter indicated the FLUMIST expired at the beginning of the flu season.  There was no adverse event associated with this event;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information received on 09-Apr-2009:  product complaint investigation results.									Y	12/04/2008	12/04/2008	0		PVT	PVT	Concomitant Drug(s) Not Reported		No medical history information collected.  No allergies to FLUMIST preservatives		MEDI0007713	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355628	08/13/2009	IA	43.0	43		F	04/09/2009	A non-serious report of administration of expired FLUMIST to two patients was received from a pharmacist concerning a 43-year-old female. The patient's medical history and concomitant medications were not available. On 06-Jan-2009, the patient received expired FLUMIST (expiration date 30-Dec-2008) at a Pharmacy. The pharmacist states that she did not check the expiration date prior to administration. The patient was doing well. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 09-Apr-2009: product complaint investigation results.									Y	01/06/2009	01/06/2009	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007717	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500563P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355631	08/13/2009	OR	22.0			F	03/20/2009	A non-serious report of administration of expired product has been received from a Registered Nurse concerning a 22-year-old female who received FLUMIST.  Medical history and concomitant medications were not reported.  On 08-Jan-2009, the patient received FLUMIST that expired on 24-Dec-2008.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  On 03-Feb-2009, the reporter confirmed that the patient did not experience any late-occurring adverse events.  Additional information received on 20-Mar-2009 included Product Complaint Investigative results.									Y	01/08/2009	01/08/2009	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007726	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500559P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355633	08/13/2009	MO	5.0	5		M	04/09/2009	A non-serious, spontaneous report of administration of expired product was received from a registered nurse concerning a five year-old male subsequent to FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding products from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 29-Jan-2009 and incorporated into the narrative: no adverse events reported after follow-up. Additional information received on 09-Apr-2009: product complaint investigation results.									Y	01/07/2009	01/07/2009	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0007727	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500548P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355636	08/13/2009	MO	5.0	5		F	04/09/2009	A non-serious, spontaneous report of administration of expired product was received from a nurse concerning a five year-old female subsequent to FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 29-Jan-2009 and incorporated into the narrative: no adverse events reported after follow-up. Additional information received on 09-Apr-2009: product complaint investigation results.									Y	01/07/2009	01/07/2009	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0007728	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500548P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355637	08/13/2009	MO	8.0	8		F	04/09/2009	A non-serious, spontaneous report of administration of expired product was received from a nurse concerning an eight year-old female subsequent to FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Based on the results of the investigation, the root cause for the medication error were caused by 1) customers not discarding product form the previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 29-Jan-2009 and incorporated into the narrative: no adverse events reported after follow-up. Additional information received on 09-Apr-2009: product complaint investigation results.										01/07/2009	01/07/2009	0		PVT	OTH	Concomitant Drug (s) Not Reported				MEDI0007729	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500548P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355640	08/13/2009	MD	12.0	12		M	04/09/2009	A spontaneous non-serious report of administration of expired product was received from a nurse concerning a twelve year-old male subsequent to FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication error that occurred shortly after the product expired. Additional information was received on 29-Jan-2009 and incorporated into the narrative: no adverse events reported after follow-up. Additional information received on 09-Apr-2009: product complaint investigation results.									Y	01/07/2009	01/07/2009	0		PVT	OTH	Concomitant Drug (s) Not Reported		None		MEDI0007730	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500548~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355643	08/13/2009	AZ	5.0	5		U	01/07/2009	A non-serious report of six patients received expired FLUMIST was received from a nurse concerning a five-year-old patient (gender unknown).  The patient's medical history and concomitant medications were not available.  On 01-Jan-2009, six patients from a large pediatric office were administered expired FLUMIST (23-Dec-2008).  The product was expired by 10 days.  There were no adverse events associated with these medications errors;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.   Follow-up information was received on 09-Apr-2009:  Product Complaint Investigation results.									Y	01/01/2009	01/01/2009	0		PUB	PUB	Concomitant Drug(s) Not Reported				MEDI0007738	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500550P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355645	08/13/2009	AZ	10.0	10		U	01/07/2009	A non-serious report of six patients received expired FLUMIST was received from a nurse concerning a 10-year-old patient (gender unknown). The patient's medical history included previous dose of FLUMIST. Concomitant medications were not available. On 01-Jan-2009, six patients from a large pediatric office were administered expired FLUMIST (23-Dec-2008). The product was expired by 10 days. There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	01/01/2009	01/01/2009	0		PUB	PUB	Concomitant Drugs(s) Not Reported		Second vaccination with FLUMIST		MEDI0007739	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500550P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355648	08/13/2009	RI	15.0			M	03/27/2009	A non-serious spontaneous report of administration of expired product has been received form a Registered Nurse concerning a 15 year old male who received FLUMIST. Medical history and concomitant medications were not reported. On 29-Dec-2008, this child was administered FLUMIST which expired on 28-Dec-2008. There was no adverse event associated with this error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information received on 13-jan-2009 confirmed the child has not experienced any adverse events.  Follow-up information received on 27-Mar-2009 included Product Complaint Investigative results. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customer not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.									Y	12/29/2008	12/29/2008	0		PVT	OTH	Concomitant Drug (s) Not Reported				MEDI0007696	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355649	08/13/2009	AZ	5.0	5		U	04/09/2009	A non-serious report of six patients received expired FLUMIST was received from a nurse concerning a five-year-old patient (gender unknown).  The patient's medical history and concomitant medications were not available.  On 01-Jan-2009, six patients from a large pediatric office were administered expired FLUMIST (23-Dec-2008).  The product was expired by 10 days.  There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu resulting in some medication errors that occurred  shortly after the product expired.  Follow-up information was received on 09-Apr-2009 that included the following:  Product Complaint Investigation results.									Y	01/01/2009	01/01/2009	0		PUB	PUB	Concomitant Drug(s) Not Reported				MEDI0007741	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500550P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355650	08/13/2009	RI	18.0			F	04/09/2009	A non-serious spontaneous report of administration of expired product has been received from a Registered Nurse concerning an 18 year old female who received FLUMIST. Medical history and concomitant medications were not reported. On 29-Dec-2008, this child was administered FLUMIST which expired on 28-Dec-2008. There was no adverse events associated with this error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 13-Jan-2009 confirmed the patient did not experience any adverse events after administration of expired product. Additional information received on 09-Apr-2009: product complaint investigation results.									Y	12/29/2008	12/29/2008	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0007697	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355651	08/13/2009	CA				U	03/20/2009	A non-serious spontaneous report of administration of expired product was received from a registered pharmacist concerning two patients (patients' demographic data not available) subsequent to FLUMIST. Neither medical history nor concomitant medications were reported. Sometime in the last week of Dec 2008 (specific date unknown). FLUMIST which was five days past the expiration date was administered to two patients. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. As of 23-Apr-2009, the reporter has not responded to follow-up telephone calls hence, unable to confirm any delayed occurring adverse events resulting from this error. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication error that occurred shortly after the product expired. Additional information received on 20-Mar-2009 included Product Complaint Investigative results.									Y					OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007699	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355652	08/13/2009	AZ	6.0	6		U	04/09/2009	A spontaneous non-serious report of six patients received expired FLUMIST was received from a nurse concerning a six-year-old patient (gender unknown). The patient's medical history included previous dose of FLUMIST. Concomitant medications were not available. On 01-Jan-2009, six patients from a large pediatric office were administered expired FLUMIST (23-Dec-20098). The product was expired by 10 days. There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	01/01/2009	01/01/2009	0		PUB	PUB	None		Second vaccination with FLUMIST		MEDI0007742	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500550P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355653	08/13/2009	MN				U	04/09/2009	A non-serious, spontaneous report of administration of expired product was received from a registered pharmacist concerning an adult (sex unknown) subsequent to FLUMIST. On 05-Jan-2009, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up with the reporter on 27-Jan-2009 revealed there were no delayed occurring adverse events related to expired FLUMIST administration. Follow-up with information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	01/05/2009	01/05/2009	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007704	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355654	08/13/2009	OH	5.0	5		F	04/09/2009	A non-serious spontaneous report of expired FLUMIST administered was received from a healthcare professional concerning a five year-old female.  Patient received two doses of FLUMIST, at the time of the second dose the FLUMIST had expired.  The reporter stated that they are unable to return a partial box of FLUMIST for a refund and in order to re-dose other patients they would need to purchase a new box of FLUMIST.  The reporter asked why does the FLUMIST expire in mid-seasons.  There was no adverse event associated with this event;  therefore, treatment and reporter/sponsor causality assessment are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root of cause for the medication were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medications errors that occurred shortly after the product expired.  Additional information received on 09-Apr-2009 that included the results of an investigation on medication error.									Y	12/17/2008	12/17/2008	0		PVT	PVT	Multivitamin				MEDI0007705	1						1	Expired drug administered; Incorrect dose administered	FLUN3~MEDIMMUNE VACCINES, INC.~5005445P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355655	08/13/2009	DC	10.0	10		F	04/09/2009	A non-serious, spontaneous report of administration of expired product was received from a nurse concerning a ten year-old female subsequent to FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 09-Apr-2009: product complaint investigation results.									Y	12/23/2008	12/23/2008	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0007751	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500548P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355656	08/13/2009	DC	11.0	11		F	04/09/2009	A non-serous, spontaneous report of administration of expired product was received from a nurse concerning an 11 year old female patient subsequent to FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Based on the results of the investigation, the root cause for the medications errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 09-Apr02009: product complaint investigation results.									Y	12/23/2008	12/23/2008	0		PVT	OTH	Concomitant Drug (s) Not Reported				MEDI0007752	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500548P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355657	08/13/2009	NJ	5.0	5		F	01/06/2009	A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a five-year-old female who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient received the FLUMIST on 31-Dec-2008, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with the same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event									Y	12/31/2008	12/31/2008	0		PVT	PVT	None		None		MEDI0007753	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355658	08/13/2009	NJ	5.0	5		M	01/06/2009	A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a five-year-old male who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient is one of a pair of siblings who received the FLUMIST on 31-Dec-2008, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse events.									Y	12/31/2008	12/31/2008	0		PVT	PVT	Concomitant Drug(s) Not Reported				MEDI0007754	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355660	08/13/2009	NJ	5.0	5		F	01/06/2009	A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a five-year-old female who received FLUMIST.  The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009.  Neither the patient's medical history nor concomitant medications were reported.  The patient is one of a pair of twin girls who received the FLUMIST on 02-Jan-2009, which expired on 30-Dec-2008.  All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008.  All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines.  The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients.  There was no adverse event associated with this medication error as of 15-Jan-2009;  therefore, treatment and reporter/sponsor causality assessment are not applicable, and the event is considered resolved.  Additional information received on 15-Jan-2009 and incorporated into the narrative:  patient's demographics and outcome of adverse  event.									Y	01/02/2009	01/02/2009	0		PVT	PVT	Concomitant Drug(s) Not Reported		Patient is one of a set of twin girls		MEDI0007757	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355661	08/13/2009	NJ	5.0	5		F	01/06/2009	A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a five-year-old female who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history concomitant medications were reported. The patient is one of a pair of twin girls who received the FLUMIST on 02-Jan-2009, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot # delivered to the clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associate with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event.									Y	01/02/2009	01/02/2009	0		PVT	PVT	Concomitant Drug (s) Not Reported		Patient is one of a set of twin girls;		MEDI0007758	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355662	08/13/2009	NJ	7.0	7		M	01/06/2009	A non serious spontaneous report of administration of expired product was received from a registered nurse concerning a seven-year-old male subsequent to FLUMIST. The patient is one of the 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medial history nor concomitant medications were reported. The patient received the FLUMIST on 02-Jan-2009, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable,and the event is considered resolved. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event.									Y	01/02/2009	01/02/2009	0		PVT	PVT	None		None		MEDI0007759	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355664	08/13/2009	NJ	6.0	6		F	01/06/2009	A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a six-year-old female who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient is one of a pair of siblings who received the FLUMIST on 05-Jan-2009, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with the same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event.									Y	01/05/2009	01/05/2009	0		PVT	PVT	None		None		MEDI0007761	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355666	08/13/2009	MO	9.0			F	04/09/2009	A non-serious spontaneous report of administration of expired product was received from a nurse practitioner concerning a 9-year-old female subsequent to FLUMIST.  Neither medical history nor concomitant medications were reported.  On 06-Jan-2009, FLUMIST which expired on 28-Dec-2008 was administered to the patient.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information was received on 09-Apr-2009: product complaint investigation results.  Additional information was received on 24-Apr-2009:  route of administration of suspect FLUMIST, where the patient was vaccinated and that no delayed adverse events resulted from this error.									Y	01/06/2009	01/06/2009	0		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0007765	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500561P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355667	08/13/2009	GA	26.0	26		F	01/13/2009	A spontaneous non-serious report of administration to a pregnant female was received from a physician concerning a 26 year old female patient. On 19-Dec-2008, FLUMIST was unknowingly administered to a woman that was two weeks pregnant. Past obstetrical history included: Para 1, Gravida 1, Premature 0, Spontaneous Abortion:0, Elective termination:0. The patient's last menstrual period was 19-Nov-2008. The estimated date of delivery was 26-Aug-2009. The pregnancy was ongoing. There was no adverse event associated with this pregnancy at the time of the report. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to report when the pregnancy ended and if the patient experienced any adverse events during pregnancy.									U	12/19/2008	12/19/2008	0		PUB	OTH	Concomitant Drug (s) Not Reported		Past obstetrical history: Para 1, Gravida 1, Premature 0, Spontaneous Abortion 0, Elective termination 0.		MEDI0007768	1						1	Contraindication to vaccination; Drug exposure during pregnancy	FLUN3~MEDIMMUNE VACCINES, INC.~500587~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355668	08/13/2009	RI	12.0			F	01/13/2009	A non-serious spontaneous report of cold like symptoms has been received from a consumer concerning a 12-year-old female, subsequent to FLUMIST.  No past medical history nor concomitant medications were reported.  The patient received FLUMIST on 06-Jan-2009.  The patient began to experience cold like symptoms approximately five days receiving FLUMIST, and was reportedly feeling pretty bad on 13-Jan-2009.  The outcome was not reported.									U	01/06/2009	01/13/2009	7		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007769	1						1	Feeling abnormal; Nasopharyngitis	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355669	08/13/2009		9.0	9		F	04/09/2009	A non-serious spontaneous report of administration of expired FLUMIST to two patients was received from a pharmacist concerning a nine-year-old female.  The patient's medical history and concomitant medications were not available.  On 06-Jan-2009, the patient received expired FLUMIST (expiration date 30-Dec-2008) at a Pharmacy.  The pharmacist states that she did not check the expiration date prior to administration.  The patient was doing well.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information was received on 09-Apr-2009:  product complaint investigation results.									Y	01/06/2009	01/06/2009	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007776	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500563P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355670	08/13/2009	RI	33.0			F	01/15/2009	A non-serious spontaneous report of asthma attack and accidental exposure has been received from a Registered Nurse concerning a 33-year-old female. Medical history included asthma (since childhood) and colitis. The patient (nurse) takes azathioprine for her colitis and salbutamol for her asthma. The reporter is a RN who works in a community health center and administers FLUMIST. The nurse did not receive FLUMIST herself. The nurse reported she has an asthma attack after she administers FLUMIST to a patient. She clarified that she has had 15 asthma attacks this flu season beginning in 2008. These attacks have occurred about 5-10 minutes after she administers the FLUMIST. The nurse has had to increase her asthma medication, and on occasion had to use a nebulizer (as well as her salbutamol inhaler). No attack has resulted in a hospitalization. Per the reporter after treatment she recovers but the event always returns.									Y					PUB	OTH	IMURAN; PROVENTIL	Asthma; Colitis	Asthma (since childhood); Colitis		MEDI0007780	1						1	Accidental exposure; Asthma; Condition aggravated	FLUN3~MEDIMMUNE VACCINES, INC.~500577P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355671	08/13/2009	NC	20.0	20		F	01/20/2009	A non-serious spontaneous report of fever, fatigue, nasal congestion, and sneezing has been received from a nurse concerning a 20-year-old female patient subsequent to FLUMIST.  No past medical history nor concomitant medications were reported.  The patient received FLUMIST on 14-Jan-2009 for the first time.  Within 48 hours after receiving FLUMIST, the patient developed a fever, fatigue, nasal congestion, and sneezing.  The patient did not recall being in close proximity to anyone with similar symptoms during the week prior to onset of the symptoms.  The patient  recovered from the events on 22-Jan-2009.									Y	01/14/2009				PUB	OTH	Concomitant Drug(s) Not Reported		Patient's first flu vaccination		MEDI0007791	1						1	Fatigue; Nasal congestion; Pyrexia; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~500577P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355672	08/13/2009	NJ	13.0	13		M	01/15/2009	A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a 13-year-old male who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-2009. Neither the patient's medical history nor concomitant medications were reported. The patient received the FLUMIST on 05-Jan-2009, which expired 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot # delivered to the pediatric clinic on 21-oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic an only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	01/05/2009	01/05/2009	0		PVT	PVT	Concomitant Drug (s) Not Reported				MEDI0007797	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355754	08/13/2009	TX	6.0			M	03/31/2009	A non-serious spontaneous report of 29 patients received expired FLUMIST was received from a physician concerning a six-year-old male. The patient's medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. Additional information was received on 31-Mar-2009 that included the results of a lot investigation: Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug (s) Not Reported				MEDI0007878	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355755	08/13/2009	TX	5.0			F	03/31/2009	A non-serious spontaneous report of 29 patients received expired FLUMIST was received from a physician concerning a five-year-old female. The patient's medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. Additional information was received on 31-Mar-2009 that included the results of a lot investigation: Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug (s) Not Reported				MEDI0007880	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355756	08/13/2009	TX	5.0			M	03/31/2009	A non-serious spontaneous report of 29 patients received expired FLUMIST was received from a physician concerning a five-year-old male. The patient's medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. Additional information was received on 31-Mar-2009 that included the results of a lot investigation: Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug (s) Not Reported				MEDI0007882	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355757	08/13/2009	TX	40.0			F	02/05/2009	A non-serious spontaneous report of 29 patients received expired FLUMIST was received from a physician concerning a 40-year-old female. The patients' medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. Additional information was received on 31-Mar-2009 that included the results of a lot investigation: Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug (s) Not Reported				MEDI0007883	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355758	08/13/2009	NJ	7.0	7		M	01/15/2009	A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a seven-year-old male who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medication were reported. The patient received the FLUMIST on 05-Jan-2009, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	01/05/2009	01/05/2009	0		PVT	PVT	Concomitant Drug (s) Not Reported				MEDI0007799	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500554P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355759	08/13/2009	TX	16.0			F	02/05/2009	A non-serious spontaneous report of 29 patients received expired FLUMIST was received form a physician concerning a 16-year-old female. The patients' medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Sine the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events with the medication error.										01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug (s) Not Reported				MEDI0007890	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355760	08/13/2009	TX	7.0			F	02/05/2009	A non-serious spontaneous report of 29 patients received expired FLUMIST was received form a physician concerning a seven-year-old female. The patients' medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Sine the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events with the medication error.									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug(s) Not Reported				MEDI0007893	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355761	08/13/2009	TX	7.0			F	02/05/2009	A non-serious spontaneous report of 29 patients received expired FLUMIST was received from a physician concerning a seven-year-old female. The patients' medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Sine the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events with the medication error.									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug(s) Not Reported				MEDI0007896	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355762	08/13/2009	TX	7.0			M	02/05/2009	A non-serious spontaneous report of 29 patients received expired FLUMIST was received form a physician concerning a seven-year-old male. The patients' medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Sine the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events with the medication error.									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug (s) Not Reported				MEDI0007897	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355763	08/13/2009	NM	27.0			F	01/23/2009	A non-serious spontaneous report of FLUMIST administration to pregnant female was received from a physician concerning a 27-year-old female patient. On 26-Dec-2008, FLUMIST was administered by mistake to the patient who was 16 weeks pregnant. There was no adverse event associated with this FLUMIST exposure to a pregnant female as of 13-Feb-2009. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.									N	12/26/2008	12/26/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007812	1						1	Contraindication to vaccination; Drug exposure during pregnancy	FLUN3~MEDIMMUNE VACCINES, INC.~500576P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355764	08/13/2009	IA	13.0			F	01/27/2009	A non-serious spontaneous report of administration of expired product was received from a consumer concerning a 13-year-old female. There was no adverse event associated with this medication error 20 days after the error occurred; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	01/07/2009	01/07/2009	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007821	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500548P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355765	08/13/2009	FL	9.0			M	01/27/2009	A  spontaneous, non-serious report of GERD and ulcer has been received from a mother concerning a nine-year-old male patient subsequent to FLUMIST. Medical history and concomitant medications were not reported. On 19-Jan-2009, the patient received FLUMIST. On 26-Jan-2009, one week after receiving FLUMIST, the patient complained about chest pain when drinking something cold. He said it hurt all the way to his back. On the same day, the patient went to a physician, who diagnosed him with GERD or an ulcer. The outcome of GERD and ulcer was not reported.									U	01/19/2009	01/26/2009	7		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007822	1						1	Chest pain; Gastrooesophageal reflux disease; Ulcer	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355766	08/13/2009	TX	5.0			M	02/05/2009	A non-serious spontaneous report of 29 patients received expired FLUMIST was received form a physician concerning a five-year-old female. The patients' medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Sine the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events with the medication error.									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug (s) Not Reported				MEDI0007898	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355767	08/13/2009	TX	6.0			M	02/05/2009	A non-serious spontaneous report of 29 patients received expired FLUMIST was received form a physician concerning a six-year-old female. The patients' medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Sine the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events with the medication error.									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug (s) Not Reported				MEDI0007899	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355768	08/13/2009	MN	59.0			M	01/27/2009	A spontaneous, non-serious report of FLUMIST given to 59-year-old was received from a nurse. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	10/29/2008	10/29/2008	0		PVT	PVT	Concomitant Drug (s) Not Reported				MEDI0007841	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355769	08/13/2009	TX	9.0			F	02/05/2009	A non-serious spontaneous report of '29 patients received expired FLUMIST was received from a physician concerning a nine-year-old female. The patients' medical history included no history of asthma. Concomitant medication were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error.									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug (s) Not Reported				MEDI0007902	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355770	08/13/2009		5.0			M	04/09/2009	A non-serious spontaneous report of administered expired FLUMIST was received from a nurse concerning a five-year-old male. The patient's concomitant medication history included receiving a dose of FLUMIST four weeks ago. On 02-Feb-2009, the patient received a booster dose of FLUMIST, which expired on 01-Feb-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors ere caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 09-Apr-2009 that included the results of an investigation regarding a medication error. Additional information was received on 09-Apr-2009 that included the results of an investigation regarding a medication error.									Y	02/02/2009	02/02/2009	0		OTH	OTH	Concomitant Drug (s) Not Reported		Received first dose 4 weeks ago		MEDI0007850	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500576P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355772	08/13/2009	TX	8.0			M	02/05/2009	A non-serious spontaneous report of '29 patients received expired FLUMIST was received from a physician concerning a eight-year-old female. The patients' medical history included no history of asthma. Concomitant medication were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug (s) Not Reported				MEDI0007905	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355773	08/13/2009	TX	5.0			F	02/05/2009	A non-serious spontaneous report of '29 patients received expired FLUMIST was received from a physician concerning a five-year-old female. The patients' medical history included no history of asthma. Concomitant medication were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug (s) Not Reported				MEDI0007906	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355774	08/13/2009	TX	35.0			F	02/05/2009	A non-serious spontaneous report of '29 patients received expired FLUMIST was received from a physician concerning a 35-year-old female. The patients' medical history included no history of asthma. Concomitant medication were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug (s) Not Reported				MEDI0007908	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355775	08/13/2009	VA	30.0			F	02/02/2009	A non-serious spontaneous report of administration to pregnant female was received from a physician concerning a 30-year-old female who received FLUMIST.  Neither medical nor obstetrical history was provided.  FLUMIST was given to the pregnant woman by mistake.  There was no adverse event reported to date.  Treatment and reporter/sponsor causality assessments are not applicable.  The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.									U	02/02/2009	02/02/2009	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007852	1						1	Contraindication to vaccination; Drug exposure during pregnancy	FLUN3~MEDIMMUNE VACCINES, INC.~500588P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355776	08/13/2009	MA	11.0			M	02/02/2009	A spontaneous, non-serious report of dizziness, lightheadedness, ear infection, sinus infection, stomach ache, fever, body aches, sore throat, congestion, headaches and malaise has been received from a patient's mother concerning an 11-year-old male patient subsequent to FLUMIST therapy. Medical history and concomitant medications were not reported. On 27-Oct-2008, the patient received FLUMIST. Since the patient received FLUMIST, he has continued to have problems. Immediately after receiving FLUMIST, the child felt dizzy an lightheaded. A couple of days later, he had a stomach ache, fever, body aches, sore throat and congestion; he also had bad headaches. The patient went to the doctor's office and was diagnosed with a sinus infection; he was ministered antibiotics (unspecified). He continued to have headaches, malaise and stomach complaints. The patient also went to see a neurologist; an MRI was normal. He continued to have ear and sinus infection with sore throat. The child was not immunocompromised. The events of sinus infection, ear infection and sore throat were ongoing. The outcome of dizziness, lightheadness, stomach ache, fever, congestion, headaches and malaise were unknown.									N	10/27/2008	10/27/2008	0	MRI, normal	OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007853	1						1	Abdominal pain upper; Dizziness; Ear infection; Headache; Immediate post-injection reaction; Malaise; Nuclear magnetic resonance imaging normal; Oropharyngeal pain; Pain; Pyrexia; Respiratory tract congestion; Sinusitis	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355777	08/13/2009	IL				F	04/09/2009	A spontaneous, non-serious report of administration of expired product was received from a nurse concerning an adult female patient.  On 20-Jan-2009, the patient received expired FLUMIST.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information was received on 09-Apr-2009 that included the results of an investigation for a medication error.									Y	01/20/2009	01/20/2009	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007854	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500561P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355778	08/13/2009	MN	36.0			F	04/09/2009	A non-serious, spontaneous report of administration or expired product was received from a nurse concerning a 36 year-old female subsequent to FLUMIST. On 03-Feb02009, the patient received expired FLUMIST (expiration date 09-Jan-2009). There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Additional information was received on 17-Feb-2009 and incorporated into the narrative: no events reported since vaccination. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product  expired. Additional information was received on 09-Apr-2009 that included the results of investigation for medication error.									Y	02/03/2009	02/03/2009	0		PVT	OTH	Concomitant Drug (s) Not Reported				MEDI0007858	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500567P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355779	08/13/2009	SC	6.0			F	04/09/2009	A non-serious spontaneous report of administered expired FLUMIST was received from a nurse concerning a six-year-old female.  FLUMIST that expired on 08-Jan-2009 was administered on 05-Feb-2009.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information was received on 09-Apr-2009 that included the results of an investigation for a medication error.									Y	02/05/2009	02/05/2009	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007869	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500556P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355781	08/13/2009	TN	11.0			M	03/31/2009	A non-serious spontaneous report of '29 patients received expired FLUMIST was received from a physician concerning a 11-year-old male. The patients' medical history included no history of asthma. Concomitant medication were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug (s) Not Reported				MEDI0007875	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355782	08/13/2009	TX	5.0			M	03/31/2009	A non-serious spontaneous report of '29 patients received expired FLUMIST was received from a physician concerning a five-year-old male. The patients' medical history included no history of asthma. Concomitant medication were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug (s) Not Reported				MEDI0007876	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355783	08/13/2009	TX	6.0			F	03/31/2009	A non-serious spontaneous report of 23 patients received expired FLUMIST was received from a physician concerning a six-year-old female.  The patient's medical history included no history of asthma.  Concomitant medications were not available.  On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST;  the product was expired by 11 days (expiration date: 26-Dec-2008).  The reporting physician was concerned regarding efficacy and loss of potency due to the expired product.  Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to included all their concomitant medications).  There were no adverse events associated with these medication errors;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error.  Additional information was received on 31-Mar-2009 that included the results of a lot investigation:  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug(s) Not Reported				MEDI0007877	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355784	08/13/2009	TX	6.0			M	02/05/2009	A non-serious spontaneous report of '29 patients received expired FLUMIST was received from a physician concerning a six-year-old male. The patients' medical history included no history of asthma. Concomitant medication were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are									Y	01/06/2009	01/06/2009	0		MIL	OTH	Concomitant Drug (s) Not Reported				MEDI0007909	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~550552P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355786	08/13/2009	LA	7.0	7		F	02/06/2009	A non-serious spontaneous report of erythema multiforme, blisters on both legs and a few on arms and sore in right nostril and upper lip has both legs and a few on arms and sore in right nostril and upper lip has been received from a physician, concerning a seven-year-old female subsequent to FLUMIST therapy.  The patient had no significant medical history.  Concomitant medication included MUPIROCIN.  The patient previously received FLUMIST via intranasal route on 09-Oct-2008 for flu prevention.  The patient's parent called the physician's office to report that one to two days after receiving FLUMIST therapy, the patient developed a sore in the right nostril and upper lip as well as blisters on both legs and a few on her arms.  On 22-Oct-2008, she was seen by her physician and diagnosed with erythema multiforme.  Pictures were taken of the lesions on her legs.  The patient had an eight-year-old brother vaccinated on the same day who did not experience any events.  The events of erythema multiforme, blisters on both legs and a few on arms and sore in right nostril and upper lip resolved on an unspecified date in Oct-2008.									Y	10/09/2008			The patient had an eight-year-old brother vaccinated on the same day who did not experience any events;	PVT	PVT	MUPIROCIN				MEDI0007911	1						1	Blister; Erythema multiforme; Oral disorder	FLUN3~MEDIMMUNE VACCINES, INC.~500545P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355787	08/13/2009	NJ	14.0			M	02/10/2009	A non-serious spontaneous report of positive influenza A test was received from a physician concerning a 14 year-old male, subsequent to FLUMIST. The, patient received FLUMIST on 01-Oct-2008. On 09-Feb-2009 the patient tested positive for influenza A. The outcome and causality of the event to FLUMIST were not reported.									U	10/01/2008	02/09/2009	131	09-Feb-2009 Influenza A test positive	PVT	OTH	Concomitant Drug (s) Not Reported				MEDI0007918	1						1	Influenza; Influenza serology positive	FLUN3~MEDIMMUNE VACCINES, INC.~500563P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355788	08/13/2009	MD	10.0			M	02/11/2009	A non-serious spontaneous report of administration of extra dose was received from a physician concerning a 10-year-old male who received FLUMIST. The patient received two doses of FLUMIST five months apart. No medical history was reported. There was no adverse event associated with this medication error, therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y		02/11/2009			OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007926	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355789	08/13/2009	AZ	65.0			M	03/31/2009	A non-serious, spontaneous report of administration of expired FLUMIST to a 65 year old was received from a nurse practitioner concerning a 65-year-old male subsequent to FLUMIST. On 19-Jan-2009 the patient received FLUMIST that expired on 13-Jan-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 05-Mar-2009 and incorporated into the narrative: confirmed no adverse events were reported following vaccination. Additional information received on 31-Mar-2009 included Product Complaint Investigation results.									Y	01/19/2009	01/19/2009	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0007996	1						1	Expired drug administered; Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500569P~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355790	08/13/2009	AZ	42.0			F	03/31/2009	08/13/09 Non-serious, spontaneous report received from a HCP with the manufacturer regarding administration of an expired FLUMIST vaccine. DX: Medication error.  The medication error was due to the costumer not discarding the product form the previous season. The vaccine was administered shortly after the product had expired.  .  The event was considered resolved.   03/05/09 No adverse event was associated after administration of the expired vaccine.    03/31/09 Product Complaint Investigation results received.									Y	01/17/2009	01/17/2009	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007997	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500569P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355791	08/13/2009	FL	8.0			M	04/28/2009	A non-serious spontaneous report of gave expired FLUMIST was received from a nurse concerning an eight-year-old male. No medical history was reported. The FLUMIST was given on 19-Feb-2009 and had expired on 24-Dec-2008. Based on the results of the investigation, the root cause for the medications errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information received on 31-Mar-2009 included Product Complaint Investigative results. Follow-up information received on 28-Apr-2009 from reporter confirming no adverse events have occurred.									Y	02/19/2009	02/19/2009	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0008006	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500559P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355792	08/13/2009	IN	11.0	11		M	03/09/2009	A non-serious, spontaneous report of sore throat and fever was received from a physician, concerning an 11 year-old male subsequent to FLUMIST. The patient's past medical history includes ADHD and behavioral problems, without diagnosis of neurologic disease. The patient also has staring episodes and was worked up for seizure disorder although no diagnosis was made. No concomitant medications have been reported for this patient. The patient received FLUMIST on 29-Oct-2008 for influenza vaccination. The patient was brought to his doctor four times in October 2008 for sore throat and fever, although no fever was documented by the physician. On 30-Oct-2008 the patient was seen for his fourth medical visit of the month for sore throat and fever. The patient recovered from the events.									Y	10/29/2008	10/30/2008	1		OTH	OTH	Concomitant Drug (s) Not Reported	ADHD	Behavioral problems:		MEDI0008056	1						1	Oropharyngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355793	08/13/2009	FL	10.0			F	04/28/2009	A non-serious spontaneous report of gave expired FLUMIST was received from a nurse concerning an eight-year-old male. No medical history was reported. The FLUMIST was given  on 19-Feb-2009 and had expired on 24-Dec-2008. Based on the results of the investigation, the root cause for the medications errors were caused by 1) customers not discarding product form the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information received on 31-Mar-2009 included Product Complaint Investigative results. Follow-up information received on 28-Apr-2009 from reporter that confirmed no adverse events have occurred.									Y	02/19/2009	02/19/2009	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0008007	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500559P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355794	08/13/2009	MD	24.0	24		F	03/31/2009	A non-serious, spontaneous report of administered expired product was received from a nurse concerning a 24-year-old female, subsequent to FLUMIST. The patient received FLUMIST on 17-Feb-2009 which expired on 15-Feb 2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Based on the results of the investigation, the root cause for the medication error were caused by 1) customers not discarding product form the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 31-Mar-2009 included Product Complaint Investigative results.									Y	02/17/2009	02/17/2009	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0008074	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355795	08/13/2009	FL	12.0			M	02/19/2009	A non-serious spontaneous report of gave expired FLUMIST was received form a nurse concerning an eight-year-old male. No medical history was reported. The FLUMIST was given on 19-Feb-2009 and had expired on 24-Dec-2008. Based on the results of the investigation, the root cause for the medications errors were caused by 1) customers not discarding product from the previous season 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and event is considered resolved. Follow-up information received on 31-Mar-2009 included Product Complaint Investigative results. Follow-up information received on 28-Apr-2009 from reporter that confirmed that no adverse events have occurred.									Y	02/19/2009	02/19/2009	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0008008	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500559P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355796	08/13/2009	MD	4.0	4		F	02/27/2009	A non-serious, spontaneous report of administered expired product was received from a nurse concerning a four-year-old female, subsequent to FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.									Y	02/17/2009	02/17/2009	0		PVT	OTH	Concomitant Drug (s) Not Reported				MEDI0008026	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355797	08/13/2009	MD	7.0	7		M	03/31/2009	A non-serious, spontaneous report of administered expired product was received from a nurse concerning a seven-year-old male, subsequent to FLUMIST. The patient received FLUMIST on 20-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Based on the results of the investigation, the root cause for the medication error were caused by 1) customers not discarding product form the previous season and 2) product expiring during the peak of the flu season resulting in some  medication errors that occurred shortly after the product expired. Additional information received on 31-Mar-2009 included Product Complaint Investigative results.									Y	02/20/2009	02/20/2009	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0008076	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355798	08/13/2009		14.0			F	02/23/2009	A non-serious spontaneous report of eye pain, headaches, body ache, muscle ache, and sinus pain has been received from a parent concerning her 14-year-old daughter, subsequent to FLUMIST. Neither past medical history nor concomitant medications were reported. The patient received FLUMIST in January 2009. Since receiving the FLUMIST in Jan-2009, the patient has had headaches, body aches, muscle aches, sever sinus pain, and eye pain. The mother of the patient stated that the patient has been miserable everyday and has had to take ibuprofen and cetirizne hydrochloride just to be able to function. The patient has seen her physician several times and was instructed to continue taking the cetirizine hydrochloride and to call if needed, however, the patient still reports no relief. The event have not resolved.									N	01/01/2009	01/01/2009	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0008027	1						1	Eye pain; Headache; Myalgia; Pain; Sinus headache	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355799	08/13/2009	MD	9.0	9		M	03/31/2009	A non-serious, spontaneous report of administered expired product was received from a nurse concerning a nine-year-old male, subsequent to FLUMIST. The patient received FLUMIST on 20-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event  is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information received on 31-Mar-2009: included Product Complaint Investigative results.									Y	02/20/2009	02/20/2009	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0008078	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355800	08/13/2009		5.0			F	02/27/2009	A non-serious, spontaneous report of snoring and nasal congestion was received from a consumer concerning a five-year-old female subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 27-Jan-2009 (four weeks prior to date of report). The patient began having problems with nasal congestion on 24-Feb-2009 and snoring at night after receiving FLUMIST; the patient does not have a history of snoring. The patient's pediatrician says there is not a problem. The outcome for the reported adverse event was not reported.									N	01/27/2009	02/24/2009	28		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0008030	1						1	Nasal congestion; Snoring	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355801	08/13/2009	NJ	38.0	38		M	03/18/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 38-year-old male. Neither medical history nor concomitant medication were reported. On an unspecified date in Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customer not discarding product form previous season and 20 product expiring during the peak of flu season resulting in some medical error that occurred shortly after the product expired. Additional information was received on18-Mar-2009 that indicated no adverse events were reported through the medical clinic. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.									Y	01/01/2009	01/01/2009	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0008044	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355802	08/13/2009	MD	6.0	6		F	03/31/2009	A non-serious, spontaneous report of administered expired products was received from a nurse concerning a six-year-old female. Subsequent to FLUMIST. The patient received FLUMIST on 20-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information received on 31-Mar-2009: included Product Complaint Investigative results.									Y	02/20/2009	02/20/2009	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0008079	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355803	08/13/2009	MD	6.0	6		M	03/31/2009	A non-serious, spontaneous report of administered expired product was received from a nurse concerning a six-year-old male, subsequent to FLUMIST. The patient received FLUMIST on 20-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Based on the results of the investigation, the root cause of the medication error were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information on 31-Mar-2009: included Product Complaint Investigative results.									Y	02/20/2009	02/20/2009	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0008080	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355804	08/13/2009	MD	8.0	8		M	03/31/2009	A non-serious, spontaneous report of administered expired product was received form a nurse concerning an eight-year-old male, subsequent to FLUMIST. The patient received FLUMIST on 26-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Based on the results of the investigation, the root cause for the medication error were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flue season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 31-Mar-2009 included Product Complaint Investigative results.									Y	02/26/2009	02/26/2009	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0008081	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355805	08/13/2009	MD	6.0	6		M	03/31/2009	A non-serious, spontaneous report of administered expired product was received from a nurse concerning a six-year-old male, subsequent to FLUMIST. The patient received FLUMIST on 26-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information received on 31-Mar-2009: include Product Complaint Investigative results.									Y	02/26/2009	02/26/2009	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0008082	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355806	08/13/2009	TX	11.0			M	04/09/2009	A spontaneous, non-serious report of administration of expired product has been received from a certified medical assistant concerning an 11-year-old male patient subsequent to FLUMIST. On 13-Mar-2009, the patient received FLUMIST with an expiration date of 25-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 09-Apr-2009 that included the results of a lot investigation. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.									Y	03/13/2009	03/13/2009	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0008109	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500560P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355807	08/13/2009	NJ	19.0	19		F	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 19-year-old female. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-may-2009: Product Complaint Investigation results.									Y	01/26/2009	01/26/2009	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0008121	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355808	08/13/2009	NJ	26.0	26		F	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 26-year-old female. Neither medical history nor concomitant medication were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had and expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the result of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	01/26/2009	01/26/2009	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0008122	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355809	08/13/2009	NJ	26.0	26		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 26-year-old male. Neither medical history nor concomitant medications were reported. On an unspecified date in Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/01/2009	02/01/2009	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0008123	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355810	08/13/2009	NJ	24.0	24		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 24-year-old male. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reported/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	01/26/2009	01/26/2009	0		MIL	MIL	Concomitant Drug(s): Not Reported				MEDI0008124	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355811	08/13/2009	NJ	21.0	21		F	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 21-year-old female. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 12-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	01/26/2009	01/26/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008125	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355812	08/13/2009	NJ	20.0	20		F	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 23-year-old female. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	01/26/2009	01/26/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008127	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355813	08/13/2009	NJ	28.0	28		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 28-year-old female. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 12-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	01/26/2009	01/26/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008128	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355814	08/13/2009	NJ	21.0	21		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 21-year-old female. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	01/26/2009	01/26/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008129	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~560568P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355815	08/13/2009	NJ	34.0	34		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 34-year-old male. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	01/26/2009	01/26/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008130	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355816	08/13/2009	NJ	28.0	28		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 28-year-old male. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	01/26/2009	01/26/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008131	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355817	08/13/2009	NJ	36.0	36		F	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 36-year-old female. Neither medical history nor concomitant medications were reported. On 27-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	01/27/2009	01/27/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008132	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355818	08/13/2009	NJ	45.0	45		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 45-year-old male. Neither medical history nor concomitant medications were reported. On 27-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	01/27/2009	01/27/2009	0		UNK	UNK					MEDI0008133	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355819	08/13/2009	NJ	45.0	45		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 45-year-old male. Neither medical history nor concomitant medications were reported. On 27-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	01/27/2009	01/27/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008134	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355820	08/13/2009	NJ	41.0	41		F	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 41-year-old female. Neither medical history nor concomitant medications were reported. On 27-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	01/27/2009	01/27/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008135	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355821	08/13/2009	NJ	22.0	22		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 22-year-old female. Neither medical history nor concomitant medications were reported. On 27-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	01/27/2009	01/27/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008136	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355822	08/13/2009	NJ	38.0	38		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 38-year-old male. Neither medical history nor concomitant medications were reported. On 27-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	01/27/2009	01/27/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008137	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355823	08/13/2009	NJ	34.0	34		F	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 34-year-old female. Neither medical history nor concomitant medications were reported. On 02-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/02/2009	02/02/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008138	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355824	08/13/2009	NJ	40.0	40		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 40 year old male. Neither medical history nor concomitant medications were reported. On 05-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-20098, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/05/2009	02/05/2009	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0008139	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355825	08/13/2009	NJ	40.0	40		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 40-year-old male. Neither medical history nor concomitant medications were reported. On 05-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers no discarding product from previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/05/2009	02/05/2009	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0008140	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355826	08/13/2009	NJ	39.0	39		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 39-year-old male. Neither medical history nor concomitant medications were reported. On 05-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/05/2009	02/05/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008141	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355827	08/13/2009	NJ	27.0	27		F	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 27-year-old female. Neither medical history nor concomitant medications were reported. On 05-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/05/2009	02/05/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0003142	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355915	08/13/2009	NJ	40.0	40		F	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 40-year-old female.  Neither medical history nor concomitant medications were reported.  On 06-Feb-2009, the patient received expired FLUMIST vaccine.  The vaccine had an expiration date of 11-Jan-2009.  As of 18-Mar-2009, there were no adverse events associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.  Follow-up information was received on 12-May-2009:  Product Complaint Investigation results.									Y	02/06/2009	02/06/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008143	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355918	08/13/2009	NJ				M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning an adult male. Neither medical history nor concomitant medication were reported. On 09-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flue season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/09/2009	02/09/2009	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0008144	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355920	08/13/2009	NJ				M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning an adult male. Neither medical history nor concomitant medications were reported. On 09-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/09/2009	02/09/2009	0		MIL	MIL					MEDI0008145	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355921	08/13/2009	NJ	48.0	48		F	05/12/2009	Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 48-year-old female. Neither medical history nor concomitant medications were reported. On 09-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/09/2009	02/09/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008146	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355922	08/13/2009	NJ	44.0	44		F	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 44-year-old female. Neither medical history nor concomitant medications were reported. On 09-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/09/2009	02/09/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008147	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355923	08/13/2009	NJ	36.0	36		F	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 36-year-old female. Neither medical history nor concomitant medications were reported. On 09-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/09/2009	02/09/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008148	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355924	08/13/2009	NJ	44.0	44		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 44-year-old male. Neither medical history nor concomitant medications were reported. On 09-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication error that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Complaint investigation results.									Y	02/09/2009	02/09/2009	0		MIL	MIL	None		None		MEDI0008149	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355925	08/13/2009	NJ	38.0	38		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 38-year-old male. Neither medical history nor concomitant medications were reported. On an unspecified date in Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/09/2009	02/09/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008152	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355926	08/13/2009	NJ	27.0	27		F	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 27-year-old female.  Neither medical history nor concomitant medications were reported.  On 23-Feb-2009, the patient received expired FLUMIST vaccine.  The vaccine had an expiration date of 11-Jan-2009.  As of 18-Mar-2009, there was no adverse events associated with this medication errors;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.  Follow-up information was received on 12-May-2009:  Product Complaint Investigation results.									Y	02/23/2009	02/23/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008153	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355927	08/13/2009	NJ	48.0	48		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 48-year-old male. Neither medical history nor concomitant medications were reported. On an unspecified date in Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/01/2009	02/01/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008154	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355928	08/13/2009	NJ	21.0	21		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 22-year-old male. Neither medical history nor concomitant medication were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There were no adverse events associated with this medication error; therefore, the treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flue season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	01/12/2009	01/12/2009	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0008155	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355929	08/13/2009	NJ	34.0	34		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 34-year-old male. Neither medical history nor concomitant medications were reported. On 24-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/24/2009	02/24/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008156	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355930	08/13/2009	NJ	48.0	48		M	05/12/2009	Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 48-year-old male. Neither medical history nor concomitant medications were reported. On 24-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/24/2009	02/24/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008157	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355931	08/13/2009	NJ	23.0	23		F	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 23-year-old female. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic and patient demographics provided. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	01/12/2009	01/12/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008158	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568p~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355932	08/13/2009	NJ	23.0	23		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 23-year-old male. Neither medical history nor concomitant medications were reported. On 24-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/24/2009	02/24/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008159	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355953	08/13/2009	NJ	38.0	38		M	03/18/2009	Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 38-year-old male. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	01/26/2009	01/26/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008160	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355954	08/13/2009	NJ	21.0	21		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 21-year-old male. Neither medical history nor concomitant medications were reported. On 24-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/24/2009	02/24/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008161	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355955	08/13/2009	NJ	26.0	26		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 26-year-old male. Neither medical history nor concomitant medications were reported. On 24-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/24/2009	02/24/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008162	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355956	08/13/2009	NJ	26.0	26		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 26-year-old male. Neither medical history nor concomitant medications were reported. On 24-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/24/2009	02/24/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008163	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355957	08/13/2009	NJ	31.0	31		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 31-year-old female. Neither medical history nor concomitant medications were reported. On 24-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/24/2009	02/24/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008164	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355958	08/13/2009	NJ	49.0	49		M	05/12/2009	Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 49-year-old male. Neither medical history nor concomitant medications were reported. On 24-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/24/2009	02/24/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008167	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355959	08/13/2009	NJ	37.0	37		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 37-year-old male. Neither medical history nor concomitant medications were reported. On 24-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/24/2009	02/24/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008168	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355960	08/13/2009	NJ	23.0	23		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 23-year-old male. Neither medical history nor concomitant medication were reported. On 24-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flue season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/24/2009	02/24/2009	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0008169	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355961	08/13/2009	NJ	26.0	26		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 26-year-old male. Neither medical history nor concomitant medications were reported. On 24-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/24/2009	02/24/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008170	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355962	08/13/2009	NJ	24.0	24		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 24-year-old male. Neither medical history nor concomitant medications were reported. On 24-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/24/2009	02/24/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008171	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355963	08/13/2009	NJ	28.0	28		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 28-year-old male. Neither medical history nor concomitant medications were reported. On 25-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/25/2009	02/25/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008172	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355964	08/13/2009	NJ	40.0	40		M	05/12/2009	Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 40-year-old male. Neither medical history nor concomitant medications were reported. On 25-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/25/2009	02/25/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008173	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355965	08/13/2009	NJ	45.0	45		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 45-year-old male. Neither medical history nor concomitant medications were reported. On 26-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results									Y	02/26/2009	02/26/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008174	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355966	08/13/2009	NJ	33.0	33		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 33-year-old male. Neither medical history nor concomitant medication were reported. On 26-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flue season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/26/2009	02/26/2009	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0008175	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355967	08/13/2009	NJ	29.0	29		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 29-year-old male. Neither medical history nor concomitant medications were reported. On 26-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/26/2009	02/26/2009	0		MIL	MIL					MEDI0008176	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355968	08/13/2009	NJ	25.0	25		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 25-year-old male.  Neither medical history nor concomitant medications were reported.  On 12-Jan-2009, the patient received expired FLUMIST vaccine.  The vaccine had an expiration date of 11-Jan-2009.  As of 18-Mar-2009, there was no adverse events associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic and patient demographics were provided.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.  Follow-up information was received on 12-May-2009:  Product Complaint Investigation results.									Y	01/12/2009	01/12/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008177	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355969	08/13/2009	NJ	27.0	27		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 27-year-old male. Neither medical history nor concomitant medications were reported. On 26-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/26/2009	02/26/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008178	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355970	08/13/2009	NJ	45.0	45		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 45-year-old male. Neither medical history nor concomitant medication were reported. On 17-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flue season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.									Y	02/17/2009	02/17/2009	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0008179	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355972	08/13/2009	NJ				M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a male of unknown age. Neither medical history nor concomitant medications were reported. On 10-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: product complaint investigation results.									Y	02/10/2009	02/10/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008181	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355973	08/13/2009	NJ	25.0	25		M	05/12/2009	Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 25-year-old male. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11 Jan 2009. There were no adverse events associated with this medication error: therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic and patient demographics were provided. Additional information was received on 12-May-2009: Product Complaint Investigation results.									Y	01/12/2009	01/12/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008182	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355974	08/13/2009	NJ				M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a male of unknown age. Neither medical history nor concomitant medications were reported. On 10-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: product complaint investigation results.									Y	02/10/2009	02/10/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008183	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355975	08/13/2009	NJ	27.0	27		F	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 27-year-old female. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic and patient demographics received. Additional information was received on 12-May-2009: product complaint investigation results.									Y	01/12/2009	01/12/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008184	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355977	08/13/2009	NJ	43.0	43		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 43-year-old male. Neither medical history nor concomitant medications were reported. On 02-Mar-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009: product complaint investigation results.									Y	03/02/2009	03/02/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008186	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355978	08/13/2009	NJ	23.0	23		M	05/12/2009	Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 23-year-old male. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic and patient demographic data was received. Additional information was received on 12-May-2009: Product Complaint Investigation results.									Y	01/12/2009	01/12/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008188	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355979	08/13/2009	NJ	49.0	49		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 49-year-old male. Neither medical history nor concomitant medications were reported. On 02-Mar-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form the previous season and 2) product expiring during the peak of the flue season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009: product complaint investigation results.									Y	03/02/2009	03/02/2009	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0008190	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355980	08/13/2009	NJ	24.0	24		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 24-year-old male. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic and patient demographics were received. Additional information was received on 12-May-2009: product complaint investigation results.									Y	01/12/2009	01/12/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008191	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355981	08/13/2009	NJ	37.0	37		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 37-year-old male.  Neither medical history nor concomitant medications were reported.  On 02-Mar-2009, the patient received expired FLUMIST vaccine.  The vaccine had an expiration date of 11-Jan-2009.  As of 18-Mar-2009, there was no adverse events associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information was received on 12-May-2009:  product complaint investigation results.									Y	03/02/2009	03/02/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008192	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355982	08/13/2009	NJ	21.0	21		F	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 21-year-old female. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic and patient demographics information received. Additional information was received on 12-May-2009: product complaint investigation results.									Y	01/12/2009	01/12/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008193	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355983	08/13/2009	NJ	41.0	41		M	05/12/2009	Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 41-year-old male. Neither medical history nor concomitant medications were reported. On 02-Mar-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009: Product Complaint Investigation results.									Y	03/02/2009	03/02/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008194	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355984	08/13/2009	NJ	19.0	19		F	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 19-year-old female. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic and patient demographics were provided. Additional information was received on 12-May-2009: product complaint investigation results									Y	01/12/2009	01/12/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008195	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355985	08/13/2009	NJ	19.0	19		F	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 19-year-old female.  Neither medical history nor concomitant medications were reported.  On 12-Jan2009, the patient received expired FLUMISt vaccine.  The vaccine had an expiration date of 11-Jan-2009.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic and patient demographics were received.  Additional information was received on 12-May-2009:  product complaint investigation results.									Y	01/12/2009	01/12/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008196	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355986	08/13/2009	NJ	21.0	21		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 21-year-old male. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic and included patient demographics. Additional information was received on 12-May-2009: product complaint investigation results.									Y	01/12/2009	01/12/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008199	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355987	08/13/2009	NJ	41.0	41		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 40-year-old male. Neither medical history nor concomitant medication were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flue season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic and included patient demographics. Additional information was received on 12-May-2009: product complaint investigation results.										01/12/2009	01/12/2009	0		MIL	MIL	Concomitant Drug (s) Not Reported				MEDI0008200	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355988	08/13/2009	NJ	43.0	43		F	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 43-year-old female. Neither medical history nor concomitant medications were reported. On 02-Mar-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009: product complaint investigation results.									Y	03/02/2009	03/02/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008201	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355989	08/13/2009	NJ	28.0	28		M	05/12/2009	Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 28-year-old male. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic and patient demographics were provided. Additional information was received on 12-May-2009: Product Complaint Investigation results.									Y	01/12/2009	01/12/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008202	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355990	08/13/2009	NJ	23.0	23		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 23-year-old male. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root case for medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic. Additional information was received on 12-May-2009; product investigation results.									Y	01/12/2009	01/12/2009	0		MIL	MIL	None		None		MEDI0008203	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355991	08/13/2009	NJ	27.0	27		F	05/12/2009	Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 27-year-old female. Neither medical history nor concomitant medications were reported. On 02-Mar-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009: Product Complaint Investigation results.									Y	03/02/2009	03/02/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008204	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355992	08/13/2009	NJ	33.0	33		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 33-year-old male. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic. Additional information was received on 12-May-2009: product complaint investigation results.									Y	01/12/2009	01/12/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008205	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355993	08/13/2009	NJ	28.0	28		M	05/12/2009	Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 28-year-old male. Neither medical history nor concomitant medications were reported. On 02-Mar-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009: Product Complaint Investigation results.									Y	03/02/2009	03/02/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008206	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355994	08/13/2009	NJ	23.0	23		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 23-year-old male. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events reported through the medical clinic associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009: product complaint investigation results.									Y	01/12/2009	01/12/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008207	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355995	08/13/2009	NJ	20.0	20		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 20-year-old male. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009: product complaint investigation results.									Y	01/26/2009	01/26/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008208	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355996	08/13/2009	NJ	36.0	36		F	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 36-year-old female.  Neither medical history nor concomitant medications were reported.  On 11-Feb-2009, the patient received expired FLUMIST vaccine.  The vaccine had an expiration date of 11-Jan-2009.  As of 18-Mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication error were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information was received on 12-May-2009:  product complaint investigation results.									Y	02/11/2009	02/11/2009	0		MIL	MIL	Concomitant Drug (s) Not Reported.				MEDI0008209	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355997	08/13/2009	NJ	37.0	37		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 37-year-old male.  Neither medical history nor concomitant medications were reported.  On 26-Jan-2009, the patient received expired FLUMIST vaccine.  The vaccine had an expiration date of 11-Jan-2009.  As of 18-Mar-2009, there were no adverse events reported through the medical clinic associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak fo the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information was received on 12-May-2009: product complaint investigation results.									Y	01/26/2009	01/26/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008210	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356011	08/13/2009	NJ	21.0	21		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 21-year-old male. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009: product complaint investigation results.									Y	01/26/2009	01/26/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008211	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356012	08/13/2009	NJ				M	03/18/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a male of unknown age. Neither medical history nor concomitant medications were reported. On 17-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there were no adverse events associated with this medications error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.									Y	02/17/2009	02/17/2009	0		MIL	MIL	None		None		MEDI0008212	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500560P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356013	08/13/2009	NJ	23.0	23		M	05/12/2009	A non - serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 23-year-old male.  Neither medical history nor concomitant medications were reported.  On 26-Jan-2009, the patient received expired FLUMIST vaccine.  The vaccine had an expiration date of 11-Jan-2009.  As of 18-Mar-2009, there were no adverse events reported through the medical clinic associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information was received on 12-May-2009 and incorporated into the narrative:  Product complaint investigation results.									Y	01/26/2009	01/26/2009	0		MIL	MIL	Concomitant Drug (s) Not Report.				MEDI0008213	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356014	08/13/2009	NJ	20.0	20		M	05/12/2009	Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 20-year-old male. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there were no adverse events reported through the medical clinic associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.									Y	01/26/2009				MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008214	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356015	08/13/2009	NJ	33.0	33		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 33-year-old male. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.									Y	01/26/2009	01/26/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008215	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356016	08/13/2009	NJ	20.0	20		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 20-year-old male. Neither medical history nor concomitant medications were reported. On 17-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into narrative: Product complaint investigation results.									Y	02/17/2009	02/17/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008216	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356018	08/13/2009	NJ	44.0	44		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 44-year-old female. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-May-2009 that indicated no adverse events were reported through the medical clinic. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.									Y	01/26/2009	01/26/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008218	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356019	08/13/2009	NJ	21.0	21		F	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse report of administration of expired FLUMIST was received from a nurse concerning a 22-year-old female.  Neither medical history nor concomitant medications were reported.  On 17-Feb-2009, the patient received expired FLUMIST vaccine.  The vaccine had an expiration date of 11-Jan-2009.  As of 18-Mar-2009, there were no adverse events associated with this medication;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information was received on 12-May-2009 and incorporated into the narrative:  Product complaint investigation results.									Y	02/17/2009	02/17/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008219	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356020	08/13/2009	NJ	24.0	24		F	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 24-year-old female. Neither medical history nor concomitant medications were reported. On an unspecified date in Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.									Y	02/01/2009	02/01/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008220	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356021	08/13/2009	NJ	24.0			M	05/12/2009	Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 24-year-old male. Neither medical history nor concomitant medications were reported. On an unspecified date in Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.									Y					MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008224	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356022	08/13/2009	NJ	20.0	20		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 20-year-old male. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.									Y	01/26/2009	01/26/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008225	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356023	08/13/2009	NJ	35.0	35		F	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 35-year-old female. Neither medical history nor concomitant medications were reported. On an unspecified date in Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.									Y	02/01/2009	02/01/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008226	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356025	08/13/2009	NJ	20.0	20		F	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 20-year-old female.  Neither medical history nor concomitant medications were reported.  On 26-Jan-2009, the patient received expired FLUMIST vaccine.  The vaccine had an expiration  date of 11-Jan-2009.  There was no adverse events associated with this medication error;  therefore, treatment and reported/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that shortly after the product expired.  Additional information was received on 18-Mar-2009 indicated no adverse events were reported through the medical clinic.  Additional information was received on 12-May-2009 and incorporated into the narrative:  Product complaint investigation results.									Y	01/26/2009	01/26/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008228	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356027	08/13/2009	NJ	26.0	26		F	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 26-year-old female. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were rejected through the medical clinic. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.									Y	01/26/2009	01/26/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008230	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356126	08/13/2009	NJ	20.0	20		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 20-year-old male. Neither medical history nor concomitant medications were reported. On 18-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.									Y	02/18/2009	02/18/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008234	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356127	08/13/2009	NJ	45.0	45		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 45-year-old male. Neither medical history nor concomitant medications were reported. On 17-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.									Y	02/17/2009	02/17/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008236	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356128	08/13/2009	NJ	23.0	23		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 23-year-old male. Neither medical history nor concomitant medications were reported. On 17-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.									Y	02/17/2009	02/17/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008237	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356129	08/13/2009	NJ	26.0	26		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 26-year-old male. Neither medical history nor concomitant medications were reported. On 17-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.									Y	02/17/2009	02/17/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008238	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500558P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356131	08/13/2009	NJ	35.0	35		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 35-year-old male. Neither medical history nor concomitant medications were reported. On 20-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.									Y	02/20/2009	02/20/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008239	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356138	08/13/2009	NJ	26.0	26		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 26-year-old male. Neither medical history nor concomitant medications were reported. On 20-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.									Y	02/20/2009	02/20/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008241	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356139	08/13/2009	NJ	32.0	32		M	05/12/2009	Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 32-year-old male. Neither medical history nor concomitant medications were reported. On 23-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.									Y	02/23/2009	02/23/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008242	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356140	08/13/2009	NJ	46.0	46		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 46-year-old male. Neither medical history nor concomitant medications were reported. On 23-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.									Y	02/23/2009	02/23/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008243	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356141	08/13/2009	NJ	20.0	20		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 20-year-old female. Neither medical history nor concomitant medications were reported. On an unspecified date in Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.									Y	02/17/2009	02/17/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008249	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356142	08/13/2009	NJ	30.0	30		U	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 30-year-old. Neither medical history nor concomitant medications were reported. On an unspecified date in Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.									Y	02/17/2009	02/17/2009	0		MIL	MIL	Concomitant Drug(s) Not reported				MEDI0008250	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356143	08/13/2009	NJ				M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a male. Neither medical history nor concomitant medications were reported. On an unspecified date in Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.									Y	02/18/2009	02/18/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008252	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356144	08/13/2009	NJ	38.0	38		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 38-year-old male. Neither medical history nor concomitant medications were reported. On an unspecified date in Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.									Y	02/18/2009	02/18/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008253	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356146	08/13/2009	NJ	28.0	28		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 28-year-old male. Neither medical history nor concomitant medications were reported. On an unspecified date in Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.									Y	02/18/2009	02/18/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008254	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356147	08/13/2009	NJ	23.0	23		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 23-year-old male. Neither medical history nor concomitant medications were reported. On an unspecified date in Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.									Y	02/18/2009	02/18/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported				MEDI0008255	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356148	08/13/2009	NC	8.0			F	05/19/2009	A non-serious report of positive influenza A test has been received from a registered nurse concerning an eight-year-old female subsequent to FLUMIST. The patient received FLUMIST before onset of the event given in October 2008. On 19-May-2009, the patient was tested for influence A and had clinical symptoms of influenza. Outcome of the event was not provided by the reporter.									U	10/01/2008	05/19/2009	230		UNK	UNK	Concomitant Drug(s) Not Reported				MEDI0008390	1						1	Influenza; Influenza serology positive	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0354265	08/14/2009	TX	68.0	68		F	08/14/2009	Extreme pain, swelling, unable to move right arm for 24 hours.  Took Tylenol, aspirin and Soma at different intervals, drank liquids and applied heating pad.  The next 16 hours pain lessened, able to move arm slightly.  Massaged injection sites and moved right arm by lifting right hand with my left hand.  By today 8/14/09 at 10 AM, I can move right arm, still have some pain on movement, and moderate soreness of right deltoid and muscles.  Pain has diminished and movement has improved.									Y	08/12/2009	08/12/2009	0		PVT	PVT	Actonel 150 mg, Levothyroxin, Neurotin, Maxide, Carisoprodol prn, Advair, Calcium, Vitamin D, Magnesium, Fish Oil	Postop L4L5 Laminectomy May 7, 2009.  Fractures of sacrum.	Allergic to mold and dust.  Have 3 ureters.  Osteoporosis, Degenerative Joint Disease, Hypothyroidism, Narrow Angle Glaucoma, Decreased Pulmonary Function,	Severe swelling, some pain & oozing~DTaP (no brand name)~NULL~47.00~In Patient		1						1	Injected limb mobility decreased; Injection site pain; Myalgia; Oedema peripheral; Pain in extremity	DTAP~UNKNOWN MANUFACTURER~~3~~RA~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~5~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0354281	08/14/2009	TX	3.0	3		F	08/14/2009	We think patient had a seizure that lasted under 10 seconds.  Her head and torso shivered and she was non-responsive.				Y					Y	08/05/2009	08/05/2009	0		UNK	UNK	none	no	none			1						1	Chills; Convulsion; Unresponsive to stimuli	DTIPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~DT + IPV (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0354406	08/17/2009	NY	12.0	12		F	08/17/2009	Redness, painful hard lump with Pneumovax. Fever of 101.8. Vomiting									Y	08/15/2009	08/15/2009	0		PVT	UNK	ALBUTEROL	NONE	ASTHMA	FEVER~Measles + Mumps + Rubella (no brand name)~2~5.30~In Patient		1						1	Erythema; Induration; Mass; Pain; Pyrexia; Vomiting	FLUX~SANOFI PASTEUR~3173BA~1~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MEN~UNKNOWN MANUFACTURER~3029AA~1~UN~RA~MENINGOCOCCAL (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1679U~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0354408	08/17/2009	MI	5.0	5		M	08/17/2009	Patient developed a fever, headache, stomach ache, lethargy and loss of appetite approx. 40 hours after receiving vaccination.  The fever lasted for 3.5 days, spiking at 103.4 degrees F 4.5 days after vaccination.  Headache, stomach ache and loss of appetite lasted 3 days; lethargy lasted 4 days.									Y	08/06/2009	08/08/2009	2	None	PVT	UNK	Ethedent	None	None			1						1	Abdominal pain upper; Anorexia; Headache; Lethargy; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~UNKNOWN MANUFACTURER~~2~IM~RL~HEP A (NO BRAND NAME)~1	USA		Influenza
0356024	08/17/2009	NJ	20.0	20		M	05/12/2009	A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 20-year-old male.  Neither medical history nor concomitant medications were reported.  On 26-Jan-2009, the patient received expired FLUMIST vaccine.  The vaccine had an expiration date of 11-Jan-2009.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic.  Additional information was received on 12-May-2009 and incorporated into the narrative:  Product complaint investigation results.									Y	01/26/2009	01/26/2009	0		MIL	MIL	Concomitant Drug(s) Not Reported		None		MEDI0008227	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0354510	08/18/2009	MT	57.0	56		F	08/18/2009	Within 24 hours of the vaccination had debilitating stabbing pain (occipital, cervico, brachial)crescendo episode lasting 1 hour 40 minutes.  On a scale of 1 to 10, was a 10 and required ambulance service to hospital.  CRT scan showed nothing.  Three days later another episode causing another visit to hospital.				Y					N	11/19/2008	11/20/2008	1	CRT Scan showed no aneurism or other structural problems. Followup NRI with and without contrast of brain showed no problems.  2 months later MRI with and without contract of cervical spine showed possible issue at C1/C2 -- nothing conclusive.  Treated initially with Carbamazepine 100 mg daily, increasing from Nov. 2008 to May 2009 to 600 mg daily, and still pain episodes.  Five day infusion of methyl prednisolone succinate reduced pain levels during episodes and able to reduce carbamazepine to 400 mg daily, which continues through present time 8/18/09.	UNK	PVT	Bisoprol Tab generic for ZIAC 5/6.25MG	None	Borderline hypertenson and watching various unusual neurologic symptoms....optic neuritis and minor paresias....always with complete recovery			1						1	Computerised tomogram normal; Nuclear magnetic resonance imaging brain normal; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0354586	08/19/2009	MI	42.0	42		F	08/19/2009	Received flu vaccine Nov. 2008 - within weeks of injection, noticed changes in movement of arm (left) - positive stiffness with limited range of motion...  Currently under care of orthopedic surgeon.				Y					N	11/07/2008			Left shoulder X-ray	PUB	PVT	LEVOXYL	None	Allergy to Sulfa - HX: decreased THYROID.			1						1	Injected limb mobility decreased; Musculoskeletal stiffness; X-ray limb	FLU3~SANOFI PASTEUR~PMCU2744AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0354608	08/19/2009	CA	4.0	4		F	07/21/2009	A serious report of lymphadenitis has been received from a study investigator concerning a female child participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. ON 18-OCT-2008, the subject received FLUMIST. The subject was admitted to the hospital for lymphadenitis on 25-Nov-2008. The length of stay was two days. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the events was moderate. The sponsor also assessed the causality for the event as not related to FLUMIST.					Y	2			U	10/18/2008	11/25/2008	38		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0008737	1						1	Lymphadenitis	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0354609	08/19/2009	CA	3.0	3		F	07/21/2009	A serious report of septic arthritis has been received from a study investigator concerning a 39-month-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 19-Nov-2008, the subject received FLUMIST. The subject was admitted to the hospital for septic arthritis on 16-Dec-2008. The length of stay was three days. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the events was moderate. The sponsor also assessed the causality for the event as not related to FLUMIST.					Y	3			U	11/19/2008	12/16/2008	27		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0008739	1						1	Arthritis bacterial	FLUN3~MEDIMMUNE VACCINES, INC.~500583P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0354610	08/19/2009	CA	4.0	4		M	07/21/2009	A serious report of hearing loss/deafness has been received from a study investigator concerning a four-year-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 08-Nov-2008, the subject received FLUMIST. The subject was admitted to the hospital for hearing loss/deafness on 05-Dec-2008. The length of stay was one day. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the events was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.					Y	1			U	11/08/2008	12/05/2008	27		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0008740	1						1	Deafness	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0354611	08/19/2009	CA	4.0	4		F	07/21/2009	A serious report of trauma has been received from a study investigator concerning a four-year-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 04-Dec-2008, the subject received FLUMIST. The subject was admitted to the hospital for trauma on 28-Dec-2008. The length of stay was one day. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the events was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.					Y	1			U	12/04/2008	12/28/2008	24		OTH	OTH	Concomitant Drugs(s) Not Reported				MEDI0008742	1						1	Injury	FLUN3~MEDIMMUNE VACCINES, INC.~500585P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0354612	08/19/2009	CA	3.0	3		M	07/21/2009	A serious report of urinary tract infection and bacteremia has been received from a study investigator concerning a 44-month-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 01-Dec-2008, the subject received FLUMIST. The subject was admitted to the hospital for urinary tract infection and bacteremia on 19-Dec-2008. The length of stay was two days. The outcome of the events was not reported. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was moderate. The sponsor also assessed the causality for the events as not related to FLUMIST.					Y	2			U	12/01/2008	12/19/2008	18		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0008744	1						1	Bacteraemia; Urinary tract infection	FLUN3~MEDIMMUNE VACCINES, INC.~500586P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0354613	08/19/2009	CA	3.0	3		M	07/21/2009	A serious report of trauma has been received from a study investigator concerning a four-year-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 26-Sep-2008, the subject received FLUMIST. The subject was admitted to the hospital for trauma on 17-Oct-2008. The length of stay was one day. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the event was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.					Y	1			U	09/26/2008	10/17/2008	21		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0008746	1						1	Injury	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0354614	08/19/2009	CA	3.0	3		F	07/21/2009	A serious report of nail disorder has been received from a study investigator concerning a 44-month-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 07-Dec-2008, the subject received FLUMIST. The subject was admitted to the hospital for nail disorder on 11-Dec-2008. The length of stay was one day. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the event was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.					Y	1			U	12/07/2008	12/11/2008	4		OTH	OTH	Concomitant Drugs(s) Not Reported				MEDI0008747	1						1	Nail disorder	FLUN3~MEDIMMUNE VACCINES, INC.~500585P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0354615	08/19/2009	CA	3.0	3		M	07/21/2009	A serious report of trauma has been received from a study investigator concerning a 41-month-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 23-Oct-2008, the subject received FLUMIST. The subject was admitted to the hospital for trauma on 07-Nov-2008. The length of stay was one day. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the event was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.					Y	1			U	10/23/2008	11/07/2008	15		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0008748	1						1	Injury	FLUN3~MEDIMMUNE VACCINES, INC.~5005409~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0354616	08/19/2009	CA	3.0	3		F	07/21/2009	A serious report of sleep apnea and tonsillitis has been received from a study investigator concerning a 43-month-old female subject participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 09-Jan-2009, the subject received FLUMIST. The subject was admitted to the hospital for sleep apnea and tonsillitis on 16-Jan-2009. The length of stay was one day. The outcome of the events was not reported. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was mild. The sponsor also assessed the causality for the events as not related to FLUMIST.					Y	1			U	01/09/2009	01/16/2009	7		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0008750	1						1	Sleep apnoea syndrome; Tonsillitis	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0354617	08/19/2009	CA	3.0	3		M	07/21/2009	A serious report of congenital anomaly has been received from a study investigator concerning a 37-month-old male (subject number 29395693) participating in post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 02-Dec-2008, the subject received FLUMIST. The subject was admitted to the hospital for congenital anomaly on 23-Dec-2008. The length of stay was one day. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the event was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.					Y	1			U	12/02/2008	12/23/2008	21		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0008752	1						1	Congenital anomaly	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0354618	08/19/2009	CA	4.0	4		F	07/21/2009	A serious report of sleep apnea and pneumonia has been received from a study investigator concerning a four-year-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 04-Nov-2008, the subject received FLUMIST. The subject was admitted to the hospital for sleep apnea and pneumonia on 04-Dec-2008. The length of stay was three days. The outcome of the events was not reported. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was moderate. The sponsor also assessed the causality for the events as not related to FLUMIST.					Y	3			U	11/04/2008	12/04/2008	30		OTH	OTH	Concomitant Drugs(s) Not Reported				MEDI0008753	1						1	Pneumonia; Sleep apnoea syndrome	FLUN3~MEDIMMUNE VACCINES, INC.~500576P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0354619	08/19/2009	CA	4.0	4		M	07/21/2009	A serious report of encopresis has been received from a study investigator concerning a four-year-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 08-Jan-2009, the subject received FLUMIST. The subject was admitted to the hospital for encopresis on 20-Jan-2009. The length of stay was two days. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the event was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.					Y	2			U	01/08/2009	01/30/2009	22		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0008754	1						1	Encopresis	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~OT~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0354620	08/19/2009	CA	4.0	4		F	07/21/2009	A serious report of congenital anomaly has been received from a study investigator concerning a four-year-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population for 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 07-Nov-2008, the subject received FLUMIST. The subject was admitted to the hospital for congenital anomaly on 09-Nov-2008. The length of stay was five days. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the event was moderate. The sponsor also assessed the causality for the event as not related to FLUMIST.					Y	5			U	11/07/2008	11/09/2008	2		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0008755	1						1	Congenital anomaly	FLUN3~MEDIMMUNE VACCINES, INC.~500559P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0354621	08/19/2009	CA	4.0	4		F	07/21/2009	A serious report of abscess and postsurgical state/complication has been received from a study investigator concerning a four-year-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 07-NOV-2008, the subject received FLUMIST. The subject was admitted to the hospital for abscess and postsurgical state/complication on 27-Nov-2008. The length of stay was one day. The outcome of the events was not reported. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was mild. The sponsor also assessed the causality for the events as not related to FLUMIST.					Y	1			U	11/07/2008	11/27/2008	20		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0008756	1						1	Abscess; Post procedural complication	FLUN3~MEDIMMUNE VACCINES, INC.~500559P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0354622	08/19/2009	CA	2.0	2	.1	F	07/21/2009	A serious report of congenital anomaly and epilepsy has been received from a study investigator concerning a 26-month-old female subject participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 04-Nov-2008, the subject received FLUMIST. The subject was admitted to the hospital for congenital anomaly and epilepsy on 28-Nov-2008. The length of stay was one day. The outcome of the events was not reported. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was moderate. The sponsor also assessed the causality for the events as not related to FLUMIST.					Y	1			U	11/04/2008	11/28/2008	24		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0008757	1						1	Congenital anomaly; Epilepsy	FLUN3~MEDIMMUNE VACCINES, INC.~500555P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0354623	08/19/2009	CA	2.0	2	.5	M	07/21/2009	A serious report of abdominal pain and vomiting has been received from a study investigator concerning a 30-month-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 14-Nov-2008, the subject received FLUMIST. The subject was admitted to the hospital for abdominal pain and vomiting on 11-Dec-2008. The length of stay was one day. The outcome of the events was not reported. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was mild. The sponsor also assessed the causality for the events as not related to FLUMIST.					Y	1			U	11/14/2008	12/11/2008	27		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0008758	1						1	Abdominal pain; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500555P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0354624	08/19/2009	CA	3.0	3		F	07/21/2009	A serious report of trauma has been received from a study investigator concerning a 36-month-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 20-Oct-2008, the subject received FLUMIST. The subject was admitted to the hospital for trauma on 21-Oct-2008. The length of stay was one day. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the event was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.					Y	1			U	10/20/2008	10/21/2008	1		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0008759	1						1	Injury	FLUN3~MEDIMMUNE VACCINES, INC.~500540P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0354629	08/19/2009	FL	11.0	11		F	08/19/2009	Patient was in waiting room about 10 to 15 minutes after vaccination and was waiting to leave the building when patient began to complain of 'feeling funny.' Patient was brought back into exam room and patient stated that her head hurt, she felt dizzy and she felt hot. Patient was brought back into an exam room and allowed to lie down. Vitals were taken and were wnl. After lying down in the exam room for five minutes, patient stated that she felt better and wanted to leave.									Y	08/10/2009	08/10/2009	0	Glucose=95   Pulse= 82 and regular   BP= 102/60, brachial, sitting	PVT	PVT	NONE	NONE- WELL CHILD	Patient has seasonal allergies.			1						1	Blood glucose normal; Blood pressure normal; Dizziness; Feeling abnormal; Feeling hot; Headache; Heart rate normal	FLUN3~MEDIMMUNE VACCINES, INC.~500675P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB287AB~1~IM~LA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2926AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~UF551AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0354669	08/19/2009	CA	12.0	12		F	08/19/2009	bad muscle pain, severe headache, bad bone pains, neck pains,  exhaustion, runny nose, stuffy nose, sore irritated throat,  This has lasted now for 2 days.So far treated with Advil and benadryl.										08/17/2009	08/18/2009	1		PVT	PVT	none	none	none	same as this time~Influenza (Seasonal) (no brand name)~NULL~~In Patient		1						1	Bone pain; Fatigue; Headache; Myalgia; Nasal congestion; Neck pain; Oropharyngeal pain; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~50673P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0354737	08/20/2009	ME	57.0	57		F	08/13/2009	Jan 2008 diagnosed Sensory Guillain Barre - Jan 08 IVIG relapse May 2008 IVIG relapse June 2008 high dose of PREDNISONE tapering down relapse Jan-Feb 2009 up PREDNISONE dose August 2009 added LEKCEPT to PREDNISONE Chronic sensory GBS/sensory CIDP.  8/27/09 Neurology consult records received DOS 1/2/08 to 7/22/09. Assessment: Guillain-Barre Syndrome. Inflammatory Polyneuropathy, Raynaud's phenomenon. Median compression neuropathy right wrist.   Patient noticed numbness and swelling in right hand, later left hand. Tingling in toes bilaterally. Alteration in sensation (Pin, vibration) in fingers and toes. Recurrent symptoms several months later. 5 day course of IV Ig. Oral and vaginal thrush. Burning and discomfort upper right quadrant. Allergy neomycin,polymyxin/hydrocort topical. Neulogical symptoms continue and get worse if prednisone dosage is reduced.				Y				Y	N	11/12/2007	12/01/2007	19	Jan. 2, 08 - Blood CBC - ESR; Jan. 2, 08, Comprehension CMP, TSH, ANA and Rheumatoid factor, Neurological exam, motor nerve conduction study; Jan. 8, 2008 - Blood work, CSF Profile, C Reactive Protein, Antinuclear antibody, Vitamin B12, Lyme AB, IGM and IGG, Sjogrens antibodies, CQIB Antibody, MS profile, Endocrine, ACE, CSF: glucose 75, CSF protein 38, Angiotensive Con, VDRL, CSF, Serum oligoclonal bands neg, MRI Cervical, Lumbar Puncture. 8/27/09 Neurology consult records received DOS 1/2/08 to 7/22/09. LABS and DIAGNOSTICS: Electrophysiologic testing - abnormal. MRI Cervical Spine - abnormal, degenerative joint disease. CHEM - Glucose 105 mg/dL (H) GFR 54 (L) Chol/HDL Ratio (L). Immunological studies.	PVT	UNK	DIOVAN;  SIMVAS	None	Hypertension; Hyperlipidemia; Shellfish; Prinivil. 8/27/09 Neurology consult records received DOS 1/2/08 to 7/22/09. Sensitivity to cold in extremities. Hypertension, mid back pain, rosacea, hyperlipidemia, environmental allergy. Allergies to Prinivil, Pro-Banthine, allergy to shellfish, Erythromycin. Alcohol use.			1						1	Angiotensin converting enzyme; Antinuclear antibody; Blood immunoglobulin G; Blood immunoglobulin M; Blood product transfusion; Blood thyroid stimulating hormone; CSF oligoclonal band; CSF test; Chronic inflammatory demyelinating polyradiculoneuropathy; Endocrine test; Full blood count; Guillain-Barre syndrome; Lumbar puncture; Metabolic function test; Rheumatoid factor; Syphilis test; Vitamin B12	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~80684~1~IJ~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0354740	08/20/2009	KY	9.0	9		F	06/10/2009	Approx. 1 1/2 weeks after receiving, patients pupils became unequal.  Evaluation by pediatric ophthalmologist revealed no other pathological findings.  Dr. states that it was likely caused by a virus.  No neurological deficits noted.  MRI normal.  MD states that unequal pupils likely to be permanent but benign condition.									N	10/05/2007	10/15/2007	10	MRI (normal); chest X-ray (normal).	PVT	PVT	None	None	Environmental allergies; dairy intolerance.			1						1	Chest X-ray; Nuclear magnetic resonance imaging normal; Pupils unequal	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0354748	08/20/2009	GA	56.0	56		F	10/10/2008	Approx. 1 hour post injection, pt. came back with red, firm, warm knot approx. 2 1/2 in X 2 1/2 in.  Denies any other symptoms @ this time.  No tx @ this time.									Y	10/10/2008	10/10/2008	0	None	PUB	OTH		None	Demerol			1						1	Erythema; Induration; Nodule; Skin warm; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89986~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0354780	08/20/2009	NY	35.0	35		M	08/20/2009	Patient had Vaccinations at 8 am with no symptoms or complaints denied any allergy except benadryl.At 1053am patient came back to clinic complaining of chest pain, no SoB,not radiating Patient was put on 15 litres of 02 via nonrebreather and ems was called.Vital Signs were 124/88  pulse 65 respirations were 18 patient was alert and oriented				Y					U	08/20/2009	08/20/2009	0		MIL	MIL		none	Benadryl ALLERGY			1						1	Chest pain	ANTH~UNKNOWN MANUFACTURER~FAV217~5~IM~RA~ANTHRAX (NO BRAND NAME)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500679P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TYP~UNKNOWN MANUFACTURER~B1026~3~IM~LA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0354805	08/20/2009	GA	45.0	45		F	08/20/2009	Onset of flu-like symptoms ~4 hours after reciept of vaccine (e.g., myalgia, malaise, fatigue).  Onset of bilateral red eyes with some pruititis, sore throat and URI symptoms ~24 hrs after receipt of vaccine.  No fever / chills.									U	08/19/2009	08/19/2009	0	none	PVT	PVT	none	none	Allergies: Sulfa, clarithromycin, mango	exacerbation of dishydrotic eczema~Yellow fever (no brand name)~3~40.00~In Patient		1						1	Fatigue; Influenza like illness; Malaise; Myalgia; Ocular hyperaemia; Oropharyngeal pain; Pruritus; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~SP U 3190AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0354808	08/20/2009	NE	18.0	18		F	08/20/2009	Large local reaction noted 2 days after vaccination in the L deltoid.  Erythema, induration, pain at the site.				Y					Y	08/18/2009	08/19/2009	1		PVT	PVT	Desogen	No	Depression			1						1	Injection site erythema; Injection site induration; Injection site pain; Local reaction	FLUN3~MEDIMMUNE VACCINES, INC.~500681P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0702X~2~IM~RA~HPV (GARDASIL)~1|VARCEL~MERCK & CO. INC.~0723Y~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0354989	08/21/2009		52.0			F	08/21/2009	This case was reported and described the occurrence of mild ulcerative colitis in a 52-year-old female subject who was vaccinated with influenza virus vaccine (Influenza vaccine, manufacturer unspecified). The subject had been passing bloody mucus intermittently for 3 years before a diagnosis of ulcerative proctitis was made at colonoscopy. She improved on sulfasalazine and hydrocortisone enemas, but after stopping medication the subject had recurrent rectal bleeding and coincident uveitis. She was then treated with oral prednisone and the sulfasalazine was restarted. The sigmoidoscopy showed more extensive friability and exudate and the subject was hospitalized for intravenous hydrocortisone. The subject was also started on Mercaptopurine (6-mercaptopurine) at 50mg/day. She improved quickly and was discharged on sulfasalazine, tapering doses of prednisone, and an increase in 6-mercaptopurine to 100mg./day. The sigmoidoscopic appearance had been normal for 4 months when symptoms worsened, with loosening of the stools and reappearance of blood per rectum. On flexible sigmoidmoidoscopy, mucosal friability and edema were again found in rectum and rectosigmoid. The subject stated that her exacerbation had followed an Influenza vaccine shot. After 3 more months on 6-mercaptopurine during which the dose was reduced to 50mg/day because of leukopenia, the subject was much improved, having formed stools with normal mucosa throughout at colonoscopy. After 9 months on 6-mercaptopurine, the subject was in remission. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved. After the next vaccination with Influenza vaccine the events recurred. The reporter considered the events were almost certainly related to vaccination with Influenza vaccine. Please refer to case B0589174B for adverse events following the next vaccination with Influenza vaccine.									Y				Colonoscopy, Normal; Sigmoidoscopy, Abnormal	OTH	OTH	Mercaptopurine; Sulphasalazine; Prednisone	Bloody Mucus; Rectal; Bleeding; Ulcerative Proctitis; Uveitis			B0589174A	1						1	Colitis ulcerative; Colonoscopy abnormal; Condition aggravated; Diarrhoea; Gastrointestinal oedema; Leukopenia; Oedema; Proctitis ulcerative; Rectal haemorrhage; Sigmoidoscopy abnormal; Uveitis; Vaccination complication	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0354990	08/21/2009		52.0			F	08/21/2009	This case was reported in a literature article and described the occurrence of severe exacerbation of ulcerative colitis in a 52-year-old female subject who was vaccinated with Influenza (manufacturer unspecified). Please refer to case B0589174A for adverse events following vaccinations with previous dose of Influenza vaccine. The subject's medical history included bloody mucus, leukopenia, loose stools, rectal bleeding, ulcerative colitis flare, ulcerative proctitis and uveitis. Concurrent medication included Mercaptopurine. After 9 months on 6-mercaptopurine and while in remission, the subject received an injection of Influenza vaccine (subcutaneous, unknown injection site), lot number not provided. At night, the developed abdominal pain and bloody diarrhea. On examination she had very active ulcerative colitis with friability, ulceration and exudate. The subject also had recurrence of bilateral uveitis. She was hospitalized and treated with intravenous adrenocorticotropin hormone (ACTH) followed by tapering doses of prednisone. Again she improved, but incompletely. The 6-mercaptopurine was increased to 150 mg/day and the subject required larger doses of steroids, becoming very cushingoid. The ulcerative colitis was never again brought under control so that the subject was steroid-resistant and steroid-dependent. This time the ulcerative colitis was fulminant and clearly related in time. One year after the diagnosis of ulcerative colitis was established, the chronicity of her illness and the complications of steroids warranted surgical intervention. The subject underwent a total colectomy with establishment of an ileoanal pouch anastomosis. Pathology confirmed the presence of a universal ulcerative colitis and there was no involvement of the terminal ileum. After 1 year with intermittent pouchitis, the pouch and the ileum looked normal. At the time of reporting the events were resolved. The author considered the events were almost certainly related to vaccination with Influenza vaccine.					Y	0			Y				UNK	OTH	OTH	MERCAPTOPURINE	Unknown	Bloody mucus; Leukopenia; Loose stools; Rectal bleeding; Ulcerative colitis flare; Ulcerative proctitis; Uveitis		B0589174B	1						1	Abdominal pain; Colectomy total; Colitis ulcerative; Condition aggravated; Cushingoid; Diarrhoea haemorrhagic; Intestinal anastomosis; Pouchitis; Surgery; Uveitis	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0354999	08/21/2009	IL	55.0	55		F	08/21/2009	Pt given vaccine about 11 o'clock, Ate lunch about noon. At approx 1 PM reported, diarrhea X 2, severe nausea, feeling faint. Placed in recliner IV fluids given - ZOFRAN - hydrated X 2 hrs.  VSS. Home with spouse.									Y	08/21/2009	08/21/2009	0		PVT	UNK	BENTYL; Birth control pills; VALTREX	None	Irritable bowel			1						1	Diarrhoea; Dizziness; Nausea	FLU3~CSL LIMITED~05740111A~2~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0355005	08/21/2009	AL	1.0	1	.0	M	08/21/2009	Left thigh, red swollen warm to touch around injection site. Keflex ZSO/5. 5ml PO BID; possible cellulitis.									U	08/19/2009	08/20/2009	1	None	PVT	PVT	None	None	None			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~UF31710A~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB336BA~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0609Y~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0884Y~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0355006	08/21/2009	MN	23.0	23		F	08/21/2009	Developed fever, pain, redness & swelling at area of injection site day after immunization - treated with MOTRIN & antibiotic.				Y					U	08/18/2009	08/19/2009	1	None	PUB	OTH		None				1						1	Injection site erythema; Injection site pain; Injection site swelling; Pyrexia	FLU3~CSL LIMITED~02149211A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|HPV4~MERCK & CO. INC.~1129X~3~IM~RA~HPV (GARDASIL)~1|PPV~MERCK & CO. INC.~0468X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0354976	08/22/2009	MD	4.0	4		M	08/22/2009	Fever of 103, complaint of headache almost immediately, sore/dry throat, very irritable, soreness at sight, feet twitching, vomiting the next morning after shots, diarhea still going on-rash on day 3- The final vaccine was for chickenpox (but I was unclear if that is the same as smallpox)				Y					N	08/18/2009	08/18/2009	0		UNK	UNK		NO	Allergic to trees, ragweed-			1						1	Diarrhoea; Dry throat; Headache; Immediate post-injection reaction; Injection site pain; Irritability; Muscle twitching; Oropharyngeal pain; Pyrexia; Rash; Vomiting	DPP~UNKNOWN MANUFACTURER~~2~IM~LA~DIPHTHERIA TOXOID + PERTUSSIS + IPV (NO BRAND NAME)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~UNKNOWN MANUFACTURER~~2~IM~RL~HEP A (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~2~IM~RL~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~2~IM~LL~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|SMALL~UNKNOWN MANUFACTURER~~2~~LL~SMALLPOX (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0354978	08/22/2009	WA	22.0	22		F	08/22/2009	Patient given vaccin afternoon of 8/21/09. She bgan itching everywhere abou 8pm that evening. At 9pm she began to notice a generalized rash. About 10 pm she took 2 x 25 mg diphenhydramine. On the morning of 8/22/09 she was still itching and repeated the 2 x 25 mg diphenhydramine about 10:15 am. She returned to the pharmacy and was referred to urgent care asa she had non current PCP.										08/21/2009	08/21/2009	0		UNK	PVT	Microgestin	none	none	none~ ()~NULL~~In Patient|none~ ()~NULL~~In Sibling1		1						1	Pruritus generalised; Rash generalised	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLL259AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0354983	08/23/2009	IN	40.0	40		F	08/23/2009	injection @ 2130--urticaria bilat hands, elbows et knees approx. 0015 (08/23/09).  Macular rash bilat upper extremites with edema present approx. 0100.   TX:  50 mg Benadryl upon arriving at home approx. 0040; 50 mg Benadryl approx 0415.									Y	08/22/2009	08/23/2009	1	N/A	PVT	PVT	synthroid, lasix, zestril, singulair,flexeril,megadose vit. D, Ca,K,Fe and B12	N/A	Asthma, Hypertension, post-thyroid CA			1						1	Oedema; Rash macular; Urticaria	FLU3~CSL LIMITED~06949111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0355015	08/24/2009	MD	2.0	2	.0	M	08/23/2009	I saw him for well check up at 09:30. He had history of mild cough and normal exam. He had vaccines and went home. He took a nap and awoke with bark-like cough and respiratory distress.  8/31/09 Hospital medical records received for 8/19-8/20/2009.   FINAL DX: croup Records reveal patient experienced mild cough & rhinorrhea prior to office visit but had slept well.  No abnormal findings on office exam when received vaccines including initial dose of Flumist.  After nap at home, awoke w/stridor & respiratory distress.  ENT consult & laryngoscopy done which revealed an abnormally shaped epiglottis but no edema.  Had stridor & agitation upon awakening from anesthesia & admitted for observation.  Tx w/steroids & epi.  Responded well to tx & d/c to home. ICD-9 codes for DC 464.0, 786.1				Y	Y	1			Y	08/19/2009	08/19/2009	0	Lateral neck X-ray; Direct laryngoscopy by ENT due to clinical concern of epiglottis (ruled out).  8/31/09 Hospital medical records received LABS:  x-ray of neck c/w swollen epiglottis.	PVT	PVT	None	Mild URI by history	None			1						1	Cough; Laryngoscopy; Respiratory distress	FLUN3~MEDIMMUNE VACCINES, INC.~500681P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~MERCK & CO. INC.~1605X~2~IM~UN~HEP A (VAQTA)~1|HIBV~SANOFI PASTEUR~UF709AA~4~IM~UN~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~D81705~4~IM~UN~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0355080	08/24/2009	UT	1.0	1	.0	M	08/24/2009	On 9/28/08 he developed a tremor and stopped walking. Tremor persisted through 8/24/09   10/01/09 PCP medical records, consults received DOS 9/22/09 to 6/10/09. Assessment: Viral upper respiratory infection. Tremor-post vaccine. Ataxia. Parent states child began to fuss, then arms and legs began to shake. Jerky movements. Erythematous diaper rash. Diarrhea. Anterior cervical lymphadenopathy. Sleeping more than usual. Cold sweats. Tremor when reaching for objects. Neutropenia. Pharyngitis. Legs stiff. Trouble walking. Unsteady gait. Liver palpable.				Y					U	09/22/2008	09/28/2008	6	HVA; VMA. LABS and DIAGNOSTICS: Urinary HVA (-) VMA (-). MRI Brain - Normal. X-ray Femur - Normal.	PVT	PVT	AMOXIL 400mg/5mL; MUPIROCIN 21	Eczema	Eczema. Ear tubes.			1						1	Abasia; Laboratory test; Tremor; Vanillyl mandelic acid urine	FLU3~SANOFI PASTEUR~U2755AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB297AA~2~IM~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0453X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0971X~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0355089	08/24/2009	WI	5.0	5		F	08/21/2009	Began with true urticarial rash on 8/19/09. Then developed joint swelling over entire body. BENADRYL was given every 4 hours.				Y					Y	08/18/2009	08/19/2009	1		PVT	PVT	None at time of vaccination	None				1						1	Joint swelling; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500675P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~MERCK & CO. INC.~0267Y~UNK~IM~LA~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0355092	08/24/2009	MI	19.0	19		F	08/24/2009	- Had rash and soreness developed on 8/22/09 AM went to the ER in evening as it was spreading - Was put on LEVAQUIN, Prednisone and ATARAX - Was diagnosed with cystitis on Sunday.				Y					Y	08/20/2009	08/22/2009	2	No tests were done	OTH	PVT	PROZAC; BUSPAR	Sinusitis	Sulfa; Amoxicillin			1						1	Cystitis; Drug hypersensitivity; Pain; Rash	FLU3~SANOFI PASTEUR~U3171AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0024U~1~SC~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0355093	08/24/2009	PA	4.0	4		F	08/24/2009	8-19 developed swelling of face/hands/feet. Lab work consistent with (illegible)/nephritis.  10/2/09 Hospital records, allergy/immunology and neurology consults, received DOS 8/19/09 to 9/14/09. Assessment: Nephrotic Syndrome. Child presents with increased lethargy, decreased appetite and intake, and 4 extremity swelling. Arm pain at site of vaccination. Eye swelling and eye discomfort. Abdominal distension. Decreased urinary output. Fever. Increased sleepiness. Pitting edema legs. Anasarca. Increased hunger, mood swings and hyperactive behavior attributed to prednisolone.				Y	Y	3			N	08/13/2009	08/15/2009	2	Proteinuria/Hypoalbuminemia. 10/2/09 Hospital records, allergy/immunology and neurology consults, received DOS 8/19/09 to 9/14/09. LABS and DIAGNOSTICS: CHEM - Na 127 mMol/L (L) K 5.3 Meq/L (H) BUN 38 mg/dL (H) Glucose 103 mg/dL (H) Ca 7.4mg/dL (L) Albumin <1.0 grm/dL (L) Total Protein 3.3 gm/dL (L). Urinalysis - Leukocyte Esterase (1+), Nitrite (+). WBC 29/hpf (H) RBC 23 /hpf (H), Transitional Epith Cells 2/hpf (H), Hyaline Casts 16/lpf (H) WBC clumps, mucous.	PVT	PVT	ORAPRED now	None	None. 10/2/09 Hospital records, allergy/immunology and neurology consults, received DOS 8/19/09 to 9/14/09. Rhinorrhea. Strep throat. Premature 35.5 weeks.			1						1	Hypoalbuminaemia; Nephritis; Oedema peripheral; Proteinuria; Swelling face	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B116BA~1~IM~RA~DTAP + IPV (KINRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500681P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~MERCK & CO. INC.~0551Y~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0493Y~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0355257	08/25/2009	PA	15.0	15		M	08/25/2009	Had flu vaccine - shortly after got light headed, flushed, nausea - not feeling well prior to shot. P.E. neg, U.S. nml.									Y	08/20/2009	08/20/2009	0		PVT	PVT	None	None	None			1						1	Dizziness; Flushing; Malaise; Nausea	FLU3~SANOFI PASTEUR~U3189AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0355266	08/25/2009	TX	0.9	0	.9	M	08/25/2009	Rash all over body.				Y					Y	02/10/2009	02/11/2009	1		PUB	OTH	None	None	None			1						1	Rash generalised	FLU3~SANOFI PASTEUR~UT2783EA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0355274	08/25/2009	IA	5.0	5		F	08/25/2009	Fever 103.0 8/22/09									Y	08/19/2009	08/22/2009	3		PVT	PUB	Atropine eye drops	None	None			1						1	Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500675~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB336BA~1~IM~LL~HEP A (HAVRIX)~1	USA		Influenza
0355562	08/25/2009	SC	6.0			F	11/24/2008	A spontaneous non-serious report of FLUMIST squirted into a child's eye has been received from the patient's mother who is a nurse concerning a 6 year old female patient. No medical history or concomitant medications were reported. On 24-Nov-2008, the patient received FLUMIST in the pediatrician's office. During administration, the patient moved and FLUMIST was squirted into the child's eye. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.									Y	11/24/2008	11/24/2008	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0007546	1						1	Accidental exposure	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355593	08/25/2009	CA				F	09/25/2008	Vomiting, diarrhea, rocking back and forward. Skin flare up picky, pulling out the hair, very fusses. Needed BENADRYL.									N	03/07/2006	03/07/2006	0	Setting stage for early Autism	PUB	PUB			Early stages of Autism			1						1	Diarrhoea; Dyskinesia; Irritability; Trichotillomania; Vomiting	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~DTAP + HEPB + IPV (PEDIARIX)~1|FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMRV~MERCK & CO. INC.~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)~1|PPV~UNKNOWN MANUFACTURER~~5~UN~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0355621	08/25/2009	CA	0.15	0	.2	F	09/25/2008	Flu like symptoms, picky skin, thinning of the hair, very fussy. Need BENADRYL.				Y					N	10/25/2006	10/25/2006	0	Setting early stages of Autism.	PUB	PVT	None	Hives; Crying/Headaches; Hyperacted; Breathing problem				1						1	Alopecia; Autism; Influenza like illness; Irritability; Skin irritation	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~DTAP + HEPB + IPV (PEDIARIX)~1|FLUX~UNKNOWN MANUFACTURER~~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~5~UN~UN~PNEUMO (NO BRAND NAME)~1|RVX~UNKNOWN MANUFACTURER~~2~UN~UN~ROTAVIRUS (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0306745	08/26/2009		1.0			M	07/09/2009	This case was extracted from the VAERS database via QSCAN on 11 March 2009 (reference number 306745).  A one-year-old male patient received the following vaccinations on 20 February 2008: a third intramuscular injection of DAPTACEL (lot number C2800AA); a second intramuscular injection of FLUZONE No Preservative 2007-2008 ( lot number UT2459LB); a third subcutaneous injection of IPOL (lot number A0169-2); a third intramuscular injection of PREVNAR (Wyeth, lot number C45150); and a third intramuscular injection of PEDVAXHIB (Merck, lot number 0076U).  The following day, the patient fell at home and hit his head, and later presented to the emergency room with a fever.  The following day he presented to the emergency department again with fever (103.1) and upper respiratory infection symptoms including cough, post tussive emesis, and irritability.  It was noted that he had a sick sibling at home.  He was treated with intravenous antibiotics and antipyretics, and discharged to home.  The next day, on 23 February 2008, he was seen by his primary care physician with respiratory congestion, wheezing, and intercostal retractions.  He was admitted to the hospital at that time with additional symptoms of bronchiolitis, conjunctivitis, otitis media, irritability, and poor appetite.  He was initially treated with breathing treatments and intravenous antibiotics.  During the course of his hospitalization he developed a diffuse urticarial rash, inflamed conjunctiva, swelling of the hands and feet, peeling skin on the feet, and red lips.  His fever increased to 106 degrees, and on 28 February 2008 he was transferred to a higher level of care.  Laboratory testing at that time revealed the following:  CRP 273, WBC 26,000, platelets 718,000, SGOT 44; electrolytes and echocardiogram were within limits, and viral testing and blood cultures were negative.  Cardiology was consulted, and he was diagnosed with atypical Kawasaki's disease without evidence of cardiac lesions.  He was treated with intravenous immunoglobulins and aspirin, after which he improved and was discharged to home on 03 March 2008 with instructions to follow-up for serial echocardiograms.  The event was considered to be recovered.			Y		Y	0			Y	02/20/2008	02/21/2008	1		UNK	UNK					200900953	1						3	Aspartate aminotransferase increased; Blood culture negative; Blood electrolytes normal; Blood product transfusion; Bronchiolitis; C-reactive protein increased; Cheilitis; Conjunctivitis; Cough; Decreased appetite; Echocardiogram normal; Fall; Head injury; Irritability; Kawasaki's disease; Oedema peripheral; Otitis media; Platelet count increased; Post-tussive vomiting; Pyrexia; Respiratory tract congestion; Sick relative; Skin exfoliation; Upper respiratory tract infection; Urticaria; Use of accessory respiratory muscles; Viral test negative; Wheezing; White blood cell count increased; Aspartate aminotransferase increased; Blood culture negative; Blood electrolytes normal; Blood product transfusion; Bronchiolitis; C-reactive protein increased; Cheilitis; Conjunctivitis; Cough; Decreased appetite; Echocardiogram normal; Fall; Head injury; Irritability; Kawasaki's disease; Oedema peripheral; Otitis media; Platelet count increased; Pyrexia; Skin exfoliation; Upper respiratory tract congestion; Upper respiratory tract infection; Urticaria; Use of accessory respiratory muscles; Viral test negative; Vomiting; Wheezing; White blood cell count increased	DTAP~SANOFI PASTEUR~C2800A~3~SC~UN~DTAP (DAPTACEL)~3|FLU3~SANOFI PASTEUR~UT2459L~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~3|HIBV~MERCK & CO. INC.~0076U~3~IM~UN~HIB (PEDVAXHIB)~3|IPV~SANOFI PASTEUR~A0169~3~IM~UN~POLIO VIRUS, INACT. (IPOL)~3|PNC~PFIZER\WYETH~C45150~3~IM~UN~PNEUMO (PREVNAR)~3|DTAP~SANOFI PASTEUR~C2800A~3~SC~UN~DTAP (DAPTACEL)~4|FLU3~SANOFI PASTEUR~UT2459L~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~4|HIBV~MERCK & CO. INC.~0076U~3~IM~UN~HIB (PEDVAXHIB)~4|IPV~SANOFI PASTEUR~A0169~3~IM~UN~POLIO VIRUS, INACT. (IPOL)~4|PNC~PFIZER\WYETH~C45150~3~IM~UN~PNEUMO (PREVNAR)~4	USA	Life Threatening,Hospitalisation	Influenza
0355396	08/26/2009	KY	63.0	63		M	08/25/2009	On 10-01-08 he complained of soreness and unusual weakness and numbness in legs (after physical therapy).  Had to have help to & from wheelchair and bed.  Much worse Thur, Fri.  By Sat. he could not move on his own from chest down.  Convinced him to go to ER on Sunday.  Paralyzed by PM 10-05-08.  Transferred to hospital 10-05-08, put in ICU AM 10-06-08.  Code blue (heart failure 10-10-08).  See med. reports (Also I kept diary) too numerous.  9/11/09 Hospital records received DOS 10/6/08 to 10/21/08. Assessment: Cardiorespiratory failure. Advanced Guillain-Barre Syndrome. Chronic renal disease with initiation of hemodialysis. Type 2 Diabetes Mellitus with increased rhabdomyolysis. Episode of supraventricular tachycardia. Episode of cardiac arrhythmia. Probable sepsis.   Patient transfered to facility after noticing weakness in upper and lower extremity. Plasmapheresus. Renal functioning worsened. Flaccid. Pneumonia. Extubated per patient's desire. Quickly expired.  10/5/09 Death Cert received with COD=Cardiorespiratory Failure due to End Stage Renal Disease due to Guillain-Barre Syndrome	Y	10/21/2008	Y	Y	Y	17	Y	Y	N	09/09/2008	10/01/2008	22	See med. records - too numerous. 9/11/09 Hospital records received DOS 10/6/08 to 10/21/08. LABS and DIAGNOSTICS: CD4/CD8 Ratio - Normal. CSF Oligoclonal Bands (IEF) - Total Protein 133 mg/dL (H) IgG 11.20 mg/dL (H) Albumin 77.7 mg/dL (H) Synthesis Rate 11.3 (H). Serum -  IgG 558 mg/dL (L) Albumin 2200 mg/dL (L). No evidence of IgG bands in CSF or serum. CSF - Glucose 94 mg/dL (H) Sodium 146 mmol/L (H) Potassium 5.1 mmol/L (H). CHEM - Potassium 7.5 mmol/L (H) Chloride 113 mmol/L (H) BUN 104 mg/dL (H) Creatinine 3.84 mg/dL (H) Glucose 247 mg/dL (H) ALKPHOS 525 U/L (H) ALT 901 U/L (H) AST 3348 U/L (H) Amylase 191 U/L (H) Bilirubin Direct 1.0 mg/dL (H) LDH 560 U/L (H) Phos 14.1 mg/dL (H) SGGT 189 U/L (H) Uric Acid 9.5 mg/dL (H) CK 73311 U/L (H) CKMB 172.4 ng/mL (H) Troponin 6.38 ng/mL (H). CRP 24.27 mg d/L (H). D-DMR >1000 ng/mL (H). PT 23.6 drc (H). Parathroid PTH 426.2 pg/mL (H). Thyroid Profile abnormal. HGB A1C 8.2% (H). CBC - HGB 7.4 g/dL (L) HCT 22.5% (L) RBC 2.51 M/mm3 (L) RDW 18.5% (H) Platelets 143 Thou/mm3 (L) Neut 13.7 Thou/mm3 (H) WBC 22.0 Thou/mm3 (H) Sed Rate 110 mm/HR (H). Culture (R) foot - Positive Coagulase Negative Staph. Fecal Occult Blood (+). Urinalysis - Orange, Turbid, Sp Grav 1.033 (H), Protein (+) Glucose (+) Acetone (+) Occult Blood (+) WBC (+) RBC (+) Renal Epith (+). Segnmental BP LE - Abnormal.	PVT	PUB	FLOMAX; ASPIRIN; LOPID; TORSEMIDE; LYRICA; QUINAPRIL; DIOVAN; ZOCOR; CLONIDINE; ZEMPLAR; HUMULIN; Fish oil; Calcium	Diabetes; Renal failure	Diabetes; Diabetic neuropathy; Renal disease; Stroke. 9/11/09 Hospital records received DOS 10/6/08 to 10/21/08. Known history of recent myocardial infarction. Type 2 Diabetes Mellitus. Diabetic neuropathy and retinopathy. Diabetic nephropathy. Hyperlipidemia. Bilateral ankle surgery. Immobility. History of lumbar degenerative disk disease. Hypertension.			1						1	Cardiac failure; Death; Hypoaesthesia; Intensive care; Mobility decreased; Muscular weakness; Pain in extremity; Paralysis; Wheelchair user	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA155AA~1~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Results in Death	Influenza
0355411	08/26/2009	MI	33.0	33		F	08/25/2009	Initial report received on 13 August 2009 from a physician. A 33 year old female patient, who had no concurrent illnesses, but who has allergy to NEOSPORIN and a history of childhood eczema and scarlet fever, had received a first dose of influenza vaccine in October 2008. The trade name, manufacturer name, lot number, route and site of administration was unknown. Three to four hours post-vaccination, the patient experienced difficulty breathing, swelling of her throat and coughing. The patient contacted her primary care physician and was directed to take BENADRYL. The patient had no further reactions. The recovery status of the patient was not reported. Documents held by sender: None.				Y					U	10/01/2008			Not reported	OTH	OTH		The patient had no concurrent illnesses, or use of other medication at the time of vaccination in October 2008.	The patient has allergy to NEOSPORIN, and a history of childhood eczema and scarlet fever.		200903477	1						1	Cough; Dyspnoea; Pharyngeal oedema	FLUX~UNKNOWN MANUFACTURER~~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0355471	08/26/2009	MN	33.0	33		M	08/26/2009	This individual received the flu shot in the am of 8/24/09. About 1 hour later, he developed sneezing, a runny nose, and a sore throat. The following day, 8/25/09, he stayed home from work due to sore throat, runny nose, head congestion, and a flushed feeling (temp was normal). Today, 8/26/09, he states that he feels quite a bit better with just a few lingering symptoms: scratchy throat and stuffy nose.									Y	08/24/2009	08/24/2009	0	none	PUB	PUB	None	None	None			1						1	Flushing; Head discomfort; Nasal congestion; Oropharyngeal pain; Rhinorrhoea; Sneezing	FLU3~CSL LIMITED~0574911A~2~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0355485	08/26/2009	VI	11.0	11		F	08/26/2009	mother and client report at this vist (today) that approx. 2 days after the last vaccination (6/4/09), client developed a bump with water to left arm, posteriorly. this site was site for varicella. Denies bumps at other injection sites. Denies other symptoms or problems. now has scar noted to area. soft, nontender today.									Y	06/04/2009	06/06/2009	2		PUB	PUB	NONE	denied	none			1						1	Injection site scar; Injection site vesicles	FLU3~SANOFI PASTEUR~U2759AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~O571X~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~0571X~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B030AA~6~IM~LA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~0195Y~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0355499	08/26/2009	MN	51.0	51		F	08/26/2009	She recieved the flu vaccine on 8-12-09, and that pm felt very sore and swollen at injection site, soreness increased and she stated she could not sleep well because her arm was very painful and swollen, pain radiated to fingers at times. She was seen by an MD on 8-26, and had a lidocaine/cortisone injection. She felt that the vaccination was given too high on her deltoid, almost shoulder area.				Y					U	08/12/2009	08/12/2009	0		PUB	UNK	levothyroxine	no	Zithromax			1						1	Injection site pain; Injection site swelling; Pain in extremity; Sleep disorder	FLU3~CSL LIMITED~02149211A~7+~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0356155	08/26/2009	VA	61.0	61		F	02/17/2009	Initial report received from a health professional on 03 December 2008. A 61-year-old female patient received a dose of FLUZONE (lot number U2757AA); a dose of MENOMUNE (lot number UF282AA); and a dose of TWINRIX (manufacturer GlaxoSmithKline, lot number AHABB132AC) on 25 November 2008 at 4 PM. Routes and sites of administration were not reported. Fours hours later, the patient complained of congestion, sore throat and high fever (temperature was not taken). The patient took Nyquil, Benadryl and Motrin and went to bed. She awoke at 2 AM with chills, fever and malaise. The patient was very tired the next day. At the time of the report, patient outcome was unknown. The patient had previously received a dose of TWINRIX one month ago (date not specified). Follow up information was received on 05 January 2009 from a health professional. On 09 October 2008 the patient received a first dose of TWINRIX (manufacturer GlaxoSmithKline, lot number AHABB128AA) intramuscularly in the right upper arm, a first dose of TYPHIM VI ( lot number A0347) intramuscularly in the left upper arm and a first dose of IPOL (lot number AB0342) intramuscularly in the left upper arm. The patient recovered from the events on 26 November 2008. Follow up information was received on 28 January 2009 from a health professional. The patient received an initial dose of FLUZONE intramuscularly in the left upper arm, an initial dose of MENOMUNE subcutaneuosly in the right upper arm, TWINRIX intramuscularly in the upper right arm, IPOL and TYPHIM VI both in the left upper arm. The patient reported having a reaction in the 1980's to a possible flu vaccine. No other information was provided. Follow-up information received 12 February 2009 from a health care professional in response to our request for additional information pertaining to the specific flu vaccine manufacturer, lot number and type of reaction experienced by the patient during the 1980s. According to the reporter, this information was Unknown. Patient relocated to a foreign country, and we did not give the vaccine in 1980. No further information was provided. Documents held by sender: None.									Y	11/25/2008	11/25/2008	0	None reported	OTH	OTH			The patient had many unspecified drug allergies. The patient was not taking any concomitant medications and had no illness at the time of vaccination. The patient had an unspecified reaction to a flu vaccine in the 1980s (manufacturer, lot number, and type of reaction were unknown).		200803884	1						1	Chills; Fatigue; Malaise; Oropharyngeal pain; Pyrexia; Upper respiratory tract congestion	FLU3~SANOFI PASTEUR~U2757A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB132AC~2~IM~RA~HEP A + HEP B (TWINRIX)~1|MEN~SANOFI PASTEUR~UF282A~UNK~SC~RA~MENINGOCOCCAL (MENOMUNE)~1	USA		Influenza
0356168	08/26/2009	CA	4.0	4		F	12/08/2008	Initial non-serious report received from a health care professional on 06 November 2008. A four-year-old female patient received a left deltoid intramuscular injection of FLUZONE SV 2008-2009 on 30 September 2008 and since that time had been experiencing and urticarial appearance rash specifically known around the injection site only. In addition, the symptoms itchy was reported, however, it was not specified if this symptom was limited to the injection site. Specific onset date of symptoms was not reported. It was indicated that the rash had been coming and going since the patient was vaccinated. The patient had no further symptoms. The even required a visit to the doctors office. At the time of the report, the patient had not recovered. The patient had received the following vaccines on 29 August 2008: right deltoid injection of MMR (manufacturer no reported, lot number 0842X); right deltoid injection of VARICELLA (manufacturer not reported, lot number 0103X); left deltoid intramuscular injection of DAPTACEL (lot number C2957AA); left deltoid subcutaneous injection of IPOL (lot number A0491); and TB test to the left arm. Follow-up information was received 04 December 2008 from a health care professional. According to the reporter, the patient had no known illnesses at the time of vaccination and they had no prior reactions with the flu vaccine. Documents held by sender: None				Y					N	09/30/2008			Not reported	PVT	PVT			The patient had no known allergies or pre-existing medical conditions and was not taking any concomitant medications. The patient was not ill at the time of vaccination. From information received on 04 December 2008, the patient had no known illnesses at the time of vaccination and they had no prior reaction with the flu vaccine.	~Influenza (Seasonal) (no brand name)~UN~0.00~Patient	200803504	1						1	Injection site urticaria; No reaction on previous exposure to drug; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U2767A~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0356169	08/26/2009	WA	0.51	0	.5	M	11/21/2008	Initial report was received 19 November 2008 from a health care professional. A six-month old male patient had received a dose of FLUZONE SV and IPOL (manufactured by sanofi pasteur), PREVNAR (manufactured by Wyeth), and a dose of DTAP, HEP B, and HIB vaccines (manufactures not reported) on 06 February 2006 and an unspecified amount of time later, he developed hives. The lot numbers, routes and sites of vaccination were not reported. It was unknown of any corrective treatments were required for this event. Concurrent illness at the time of vaccination, concomitant medications, and pre-existing medical conditions were reported as unknown. According to the reporter, the patient had been seen by an allergist and had recovered from the event. Documents held by sender: None									Y	02/06/2006			Unknown	OTH	UNK					200803677	1						1	Urticaria	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP B (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~UNK~UN~UN~HIB (NO BRAND NAME)~1|IPV~SANOFI PASTEUR~~UNK~UN~UN~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~~UNK~UN~UN~PNEUMO (PREVNAR)~1	USA		Influenza
0355682	08/27/2009	PA	20.0	20		F	08/27/2009	Few minutes after shots, patient had a brief syncopal episode lasting 30-45 seconds; complete recovery.									Y	08/25/2009	08/25/2009	0	None	PVT	PVT	PPD; KEPPRA; LEXAPRO; ZONEGRAN; Amityiptyline; YAZ	None	Seizure disorder			1						1	Syncope	FLUN3~MEDIMMUNE VACCINES, INC.~500675F~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0087Y~UNK~UN~UN~HPV (GARDASIL)~1	USA		Influenza
0355699	08/27/2009	IL	72.0	72		M	08/27/2009	Pt was due to be discharged after undergoing cardiac catherization.  Per chart, pt became restless and nonverbal 5-10 minutes after receiving pneumonia and influenza vaccine. Pt passed out. Pt also variously decribed to have HA, tongue numbness, and to be diaphoretic and anxious.  Pt then reported trouble seeing.  CT scan subsequently revealed a CVA. 10/7/09 Medical records an DC summary received for dates 12/25/08 to 1/14/09. DC DX: Hypertensive heart disease, heart failure. Secondary DX: Cerebral embolism w/ infarction, anaphylactic shock, unspecified hemiplegia, systolic heart failure/CHF, coronary atherosclerosis, adverse affect of viral vaccine, low potassium, BPH, urinary obstruction, cataracts, homonymous hemianpsia.  Presenting SX: In ER c/o abdominal pain, worsening constipation, chest pain, and SOB, difficulty with speech past 3 days. Assessment: jugular venous distention, systolic murmur, irregular heartbeat, bi-lateral lung crackles, abdominal distention, tenderness, +BS, neuro exam WNL. Pt had cardiac cath completed w/o incident. At some point during inpatient pt had CVA. CT on 1/4/09 results, development of a large intraparenchymal hemorrhage in the right temporal and parietal lobes with significant surrounding edema and resultant right to left subta-cine and transtentoria herniation. Craniotomy performed for a right intraparenchymal hematoma converted to hemorrhage, right frontotemporal craniotomy for evacuation of hematoma, placement of ventricular drain. Pt sent to rehab facility 1/14-2/7/09 had PT and OT, speech therapy. Pt DC home and f/u with PC.			Y						Y	12/30/2008	12/30/2008	0	10/7/09 Medical records an DC summary received for dates 12/25/08 to 1/14/09. Diagnostics/Labs: Left heart cath, left heart angiocardiogram, coronary arteriogram, stress echo- abnormal- hypokinesia, injection fraction 27.3%.CXR-mild cardiac enlargement, left hip xray(-), Series of CT scans of brain after CVA and craniotomy showing improvement. Creatinine .40(L), BUN/creat ration 37.3(H), glucose(H), CK 692(H), platelets WNL, PT/INR, APTT WNL.	UNK	UNK	Lasix, Coreg, KCl, Cozaar	post cardiac catherization	post cardiac catherization 10/7/09 Medical records an DC summary received for dates 12/25/08 to 1/14/09. PMH: HTN, CHF, CAD, arthritis, cardiomegaly, appendectomy, knee replacement.			1						1	Anxiety; Aphasia; Cerebrovascular accident; Computerised tomogram abnormal; Headache; Hyperhidrosis; Hypoaesthesia oral; Loss of consciousness; Restlessness; Visual impairment	FLUX~SANOFI PASTEUR~02819ac~1~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~L407x~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Life Threatening	Influenza
0355712	08/27/2009	FL	40.0	40		F	08/27/2009	REC'D FLU VACCINE @9AM. @ 10:30AM SAME DAY BEGAN TO BREAK OUT IN HIVES [5] ON THE SAME ARM AS VACCINE WAS ADMINISTERED. BENADRYL 50MG ADMINISTERED AND CLIENT HAD NO FURTHER COMPLAINTS.									Y	08/27/2009	08/27/2009	0	N/A	PUB	PVT	ZOLOFT	N/A	BEE STINGS			1						1	Urticaria	FLU3~SANOFI PASTEUR~U3199AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0355720	08/27/2009	CO	40.0	40		F	08/27/2009	After about 10 minutes after receiving the injection my arm got hot and very itchy. Shortly after that I started to get itchy and flushed on my face and head which started to progress over my whole body. I returned to see Dr. who gave me 10mg Zyrtec. The symptoms did not improve so he gave me epinephrine IM. The itching improved after approx 15-20 minutes. I returned to work and about 2 hours later the itching and flushing on my head and face started to return. I came back to see Dr. who gave me Benadryl and prednisone (40mg). The symptoms slowly resolved. I did not have any shortness of breath, and I have never had a reaction to a flu vaccine in the past. I am not allergic to eggs.				Y					Y	08/25/2009	08/25/2009	0		MIL	MIL	Zyrtec	None	None			1						1	Flushing; Pruritus; Skin warm	FLU3~CSL LIMITED~07049111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0355743	08/27/2009	PA	16.0	16		F	08/25/2009	1118AM 3 minutes after shots were given, patient felt nauseous, became weak and fainted on the exam table. She responded immediately to ammonia inhalant; her BP 120/76. Ice pack was applied to her head. She was alert in a few minutes sitting up and ready to leave.									Y	08/25/2009	08/25/2009	0		PVT	PVT	LAMICTAL 25mg; PROZAC 10mg daily		Depression			1						1	Asthenia; Nausea; Syncope	FLUN3~MEDIMMUNE VACCINES, INC.~500675P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~MERCK & CO. INC.~0604Y~1~IM~RA~HEP A (VAQTA)~1|HPV4~MERCK & CO. INC.~0087X~1~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0355849	08/28/2009	NY				M	08/26/2009	Syncopal episode after receiving TDAP, MENACTRA, FLUMIST, HEP A.  Regained consciousness after few seconds.									Y	08/25/2009	08/25/2009	0		PVT	PVT		None	Hx of Strat 15 pills.  has glasses.			1						1	Syncope	FLUN3~MEDIMMUNE VACCINES, INC.~500677P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~MERCK & CO. INC.~0206Y~UNK~IM~RA~HEP A (VAQTA)~1|MNQ~SANOFI PASTEUR~U2B74BA~UNK~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C3355AA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0355851	08/28/2009	MI	52.0	52		F	08/28/2009	Red, Rash on left upper arm, warm to the touch.  Triamcinlone 40mg IM, antihistamine										08/24/2009				PVT	UNK			Aspirin			1						1	Injection site erythema; Injection site rash; Injection site warmth	FLU3~SANOFI PASTEUR~U3197AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0355853	08/28/2009	GA	26.0	26		F	08/28/2009	Patient received FLu Mist on 25Aug09. Before administering vaccine patient submitted a negative pregnancy test. 28Aug09 patient took a second test and it was positive.									Y	08/25/2009	08/28/2009	3	Positive Pregnancy Test	MIL	MIL						1						1	Drug exposure during pregnancy; Pregnancy test positive	FLUN3~MEDIMMUNE VACCINES, INC.~500691P~4~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355859	08/28/2009	IN	64.0	64		M	08/28/2009	Chills, sweats, body aches, light-headedness, nausea									Y	08/27/2009	08/27/2009	0		PUB	UNK		None	None			1						1	Chills; Dizziness; Hyperhidrosis; Nausea; Pain; Chills; Pain; Pyrexia	FLUX~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~u3193AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0355859	08/28/2009	IN	65.0	64		M	08/28/2009	Client states low grade fever of <100 Oral, body aches, chills.  States he is feeling better today. Recommended either Tylenol or Ibuprophen for symptomatic control and to call physician if no improvement by 8/29/09									U	08/27/2009	08/27/2009	0	none	PUB	PVT		none	none			1						2	Chills; Dizziness; Hyperhidrosis; Nausea; Pain; Chills; Pain; Pyrexia	FLUX~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~u3193AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0355863	08/28/2009	AR	6.0	6		M	08/28/2009	No adverse events noted to date.									Y	08/26/2009				PVT	PVT	BENADRYL	POISON IVY	POISON IVY-CURRENT; URI-RESOLVED, STREP PHARYNGITIS-RESOLVED,ALLERGIC RHINITIS-CONTROLLED, ASTHMA-CONTROLLED,			1						1	No adverse event	FLU3~SANOFI PASTEUR~U1367AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0355865	08/28/2009	AR	10.0	10		F	08/28/2009	NO Adverse Events to date.									Y	08/26/2009				PVT	PVT	ZYRTEC	CONSTIPATION	ALLERGIC RHINITIS-CONTROLLED			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U1367AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0355868	08/28/2009	KY	4.0	4		F	08/28/2009	Patient presented on 8/27/09 with redness and blistering over left upper arm.  Mom reports the redness began on 8/26 and began to spread, the blisters formed on the evening on 8/26.  She received Rocephin for possible cellulitis.  Mom called and the redness was spreading with swollen elbow that afternoon.  she was sent to UK Children's ER for evaluation.  She was begun on Vancomycin and then detremined to be adverse reaction with beginning resolution.  9/17/09 Hospital records received DOS 8/27/09 to 8/28/09. Assessment: Arthus Reaction. Patient was admitted with swollen left upper arm progressing in size and redness. Soft-tissue swelling. Pustule lesions area of injection site. The following morning the lesion was erythematous and warm but nontender to touch and located from shoulder to elbow on left upper extremity. Heart rate elevated. Respiratory rate elevated.  9/14/09 ICD-9 Codes Received: 999.5 Other serum reaction, 682.3 Cellulitis of arm, E949.9 Adverse effect of other and unspecified vaccines and biological substances.				Y	Y	1			Y	08/25/2009	08/26/2009	1	CBC WBC 13,000    CRP 2.5     ESR 40. 9/17/09 Hospital records received DOS 8/27/09 to 8/28/09.  LABS and DIAGNOSTICS: WBC 13.0 k/uL (H). CHEM - Glucose 105 mg/dL (H) Creatinine 0.44 mg/dL (L). C-Reactive Protein 2.5 mg/dL (H). Sed Rate 40 mm/hr (H). Blood Culture - No Growth. Vesicular Fluid Tested for Varicella Zoster Virus DNA PCR (-).	UNK	UNK		no	none			1						1	Full blood count; Injection site erythema; Injection site swelling; Injection site vesicles; Red blood cell sedimentation rate increased; White blood cell count increased	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~ac20b114cb~1~IM~LA~DTAP + IPV (KINRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500675P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~MERCK & CO. INC.~0152y~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0812y~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0355869	08/28/2009	AR	4.0	4		F	08/28/2009	NO ADVERSE EVENTS TO DATE									Y	08/26/2009				PVT	PVT	MOTRIN	OTITIS MEDIA	OTITIS MEDIA,			1						1	No adverse event	FLU3~SANOFI PASTEUR~U1367AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0355878	08/28/2009	OK	16.0	16		F	08/28/2009	None noted									U	08/24/2009			None	PUB	UNK			NONE			1						1	Inappropriate schedule of drug administration	FLU3~CSL LIMITED~02149211A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0355910	08/28/2009	MA	15.0	15		F	08/28/2009	8/24 afternoon- pt received vaccines evening- sent by nurse to ER with severe joint pain, nausea and lethargy.  8/25 Pt still in pain and vaccine sites swollen.				Y					U	08/24/2009	08/24/2009	0		PVT	PUB	None	None	Penicillin allergy;  Lumbar spondylolysis			1						1	Arthralgia; Injection site swelling; Lethargy; Nausea	FLUN3~MEDIMMUNE VACCINES, INC.~500677P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0087Y~1~IM~LA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0355934	08/28/2009	MA	13.0	13		F	08/28/2009	Pt. had nasal flu mist. Fell back in waiting room ? Fainted. Hit back of head on floor. Sent to ER by ambulance, then to another hospital.  9/8/09 Hospital records received DOS 8/27/09 to 8/29/09. Assessment: Closed head injury. Patient felt faint, queasy, and though she might 'pass out'. Syncopal event. Found on floor with clenched jaw and a little stiff. Incontinent, combative, and not making sense. Post impact seizure. (L) parietal scalp hematoma, contra coupe small (R) subarachnoid tempo-parietal bleed. Presented very upset, moaning about headache. Erythematous dermatitic rash LS area and buttocks. Abrased, scratched areas.				Y	Y	1			Y	08/27/2009	08/27/2009	0	9/8/09 Hospital records received DOS 8/27/09 to 8/29/09. CT Scan - Subarachnoid Bleed. LABS and DIAGNOSTICS: CT Scan Head- Abnormal. CBC - WBC 17.84 K cells/uL (H) Hemoglobin 13.9 g/dL (H) Hematocrit 39.6% (H) MPV 9.5 fL (H) RDW 12.6% (L)	PVT	PVT		9/8/09 Hospital records received DOS 8/27/09 to 8/29/09. Poison sumac.				1						1	Computerised tomogram abnormal; Fall; Subarachnoid haemorrhage; Syncope	FLUN3~MEDIMMUNE VACCINES, INC.~500673P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0355946	08/28/2009	WA	48.0	48		F	08/27/2009	Swollen lymph nodes under right arm pit. Injection site tender.									U	08/26/2009	08/27/2009	1		PVT	PVT	Simvastatin; lisinopril; estradiol; amitriptyline; Naproxen	none	HTN; High Cholesterol			1						1	Injection site pain; Lymphadenopathy	FLU3~SANOFI PASTEUR~U3189AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0355948	08/28/2009	MN	68.0	68		F	08/28/2009	Severe swelling and redness down arm of where flu shot given. BENADRYL.									U	08/26/2009	08/28/2009	2		PVT	PVT		UTI	RAD; PVD; HTN; Hyperlipidemia			1						1	Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~U3200AA~2~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0355951	08/28/2009	MA	11.0	11		M	08/28/2009	Pt. Received vaccines in office. When in parking lot, fainted. Mother able to hold up. No injuries noted! Responded immediately.									Y	08/27/2009	08/27/2009	0		PVT	PUB						1						1	Syncope	FLUN3~MEDIMMUNE VACCINES, INC.~500673P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B030AA~1~IM~UN~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~0695Y~1~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0355893	08/29/2009	CA	0.5	0	.5	F	08/29/2009	Fever to 103 degrees				Y					Y	08/28/2009	08/29/2009	1	none	PVT	UNK	ibuprofen	none	none			1						1	Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B210BA~3~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLUX~SANOFI PASTEUR~UT3171DA~1~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HIBV~SANOFI PASTEUR~UF616AB~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~D46874~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~D46874~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0355896	08/30/2009	OH	21.0	21		M	08/30/2009	Constant tingling in right hand. Redness and swelling of arm down to the elbow. Low grade temperature for first 12 hours. Temperature of 103 to 104F for following 48 hours.(difficultly reducing fever even with acetaminophen 1000mg every 4 hours) Low grade temp is continuing still 96 hours after injections. Vomiting first 72 hours. Severe muscle spasms in lower extremities first 72 hours.									U	08/19/2009	08/19/2009	0		PVT	UNK		none	Grade IV IVH at birth with ensuing diagnosis of Cerebral Palsy (Quad) VP Shunt for Non-Communicating Hydrocephalus			1						1	Erythema; Muscle spasms; Oedema peripheral; Paraesthesia; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0355898	08/30/2009	CA	62.0	62		F	08/30/2009	Week of NOv. 24th did not have energy, tired. Week of Dec. 8th. had weird feelings in hands and toes.(felt like I had needles in my hands and feet.) Dec. 21st. went to emergency room at medical center. Saw Dr. and he gave me  Vicodin. He felt I had pulled my back.Took meds for three days. Did not like how I felt that is why I went off the meds. Dec. 26th. returned to medical center and Dr. said I had BEll's Palsy. Finally because of my son who demanded I go to another Hospital. Because I could not stand ,walk,talk and had the needle feeling in both my hands and feet my son wanted me to go to the Hospital.I was admitted to Hospital. A Neurologist, did a  spinal tap and said I had Gullian-Barre syndrome and placed me in ICU.Where my treatment took place. I received five plasma exchanges. After the hospital I was in rehab for two weeks and physical therapy still on going.  9/8/09 Hospital records received DOS 12/26/08 to 1/03/09. Assessment Gullain-Barre syndrome, possibly due to flu vaccine. Patient presented initially due to back pain followed by numbness in her face and right facial weakness. Nausea and vomiting after eating pork chop. Mild generalized weakness. Tingling in hands and feet. Plasma exchange. Also constipation, rectal bleeding. Thoracic disc protrusion, discogenic disease. Cervical spine degenerative changes. Treated with Plasmapheresis. Paresthesias hands and feet. Wide base of gait.  ICD-9 Codes: 357.0 Guillain-Barre Syndrome, 569.3 Anorectal bleeding, 564.00 Unspecified constripation, 405.99 Unspecified secondary hypertension other cause, 458.9 Hypertension unspecified, E849.7 Injury or poisoning occuring in residential institution, 781.94 Facial weakness, E949.6 Adverse effects of other and unspecified viral and rickettsial vaccines, E849.9 Injury or poisoning occuring in an uspecified place, E879.8 Later complication of an unspecified procedure.			Y	Y	Y	7			Y	11/01/2008	11/24/2008	23	9/8/09 Hospital records received DOS 12/26/08 to 1/03/09. LABS and DIAGNOSTICS: Lumbar Puncture / CSF - Lymphocytes 2 Protein 105 mg/dL (H). MRI Brain - Abnormal. MRI Cervical and Thoracic Spine - Abnormal. ABG - PCO2 31 mm Hg (L). CHEM - BUN 20 mg/dL (H) T. Protein 5.5 g/dL (L) AST 72 U/L (H) ALT 61 U/L (H) Alk Phos 37 UL (L) Globulin 1.48 g/dL (L) Glucose 144 mg/dL (H). C-Reactive Protein 1.63 mg/dL (H). CBC - WBC 16.1 x10^9/L (H) Neut# 11.5 x10^9/L (H) Lymph# 3.3 x10^9/L (H) Mono# 1.1 x10^9/L (H). Coagulation 14.9 sec (H). Urinalysis - Hazy, WBC Esterase 2+, Protein trace, Blood trace, Epithelial 4+, Mucus present, Bacterial 3+, Casts 5-10 LPF, WBC 5-10 HPF, RBC 0-3 HPF. CT Brain - Small osteoma.	UNK	UNK	no	none	no. 9/8/09 Hospital records received DOS 12/26/08 to 1/03/09. Cholecystectomy.			1						1	Abasia; Asthenia; Blood product transfusion; Dysstasia; Facial palsy; Fatigue; Guillain-Barre syndrome; Intensive care; Muscle strain; Paraesthesia; Speech disorder	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89994~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0355971	08/31/2009	NJ				M	05/12/2009	Expired vaccine used (expired drug administered) A non-serious spontaneous report of administration of expired FluMist was received from a nurse concerning an adult male. Neither medical history nor concomitant medications were reported. On 26-Feb-2009, the patient received expired FluMist vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product complaint investigation results.									Y	02/26/2009	02/26/2009	0		MIL	MIL	Not reported				MEDI0008180	1						1	Expired drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0355976	08/31/2009	NJ	31.0	31		M	05/12/2009	Expired vaccine used (Expired drug administered). A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 31-year-old male. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic and patient demographic information was received. Additional information was received on 12-May-2009: product complaint investigation results.									Y	01/12/2009	01/12/2009	0		MIL	MIL	Concomitant Drug(s) Not reported				MEDI0008185	1						1	Expired drug administered; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500568P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356001	08/31/2009					F	08/27/2009	Initial report received on 18 August 2009 from another manufacturer (report number WAES 0907USA05484, document number 45223472) who had received the original report from an anonymous consumer. A female patient (demographics not reported) had received an influenza vaccine (flu shot) 30 years ago on an unspecified date. The trade name, manufacturer name, route and site of administration were not reported. The next day following vaccination, the patient was sick with the flu, bronchitis and an upper respiratory tract infection (not specified). It was not reported whether any diagnostic tests, or laboratory data were performed, or if the patient had received treatment. The recovery status of the patient was not reported. No contact information for follow-up was provided. No further information is expected. Documents held by sender: None.				Y					U				Not reported	UNK	UNK			The patient stated that she is allergic to a lot of different components in different medications (trade names and manufacture names not specified). The patient mentioned she tried AVAPRO and it destroyed her muscles and she could not walk. She also tried LASIX and HYDROCHLOROTHIAZIDE and had a terrible allergic reaction (unspecified). She stated she tried multiple different diuretics (could not recall trade names or descriptions of products) and had different adverse reactions to them. She recently tried Z-pack and the skin on her feet started peeling.		200903558	1						1	Bronchitis; Influenza; Upper respiratory tract infection	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0356002	08/31/2009	IN				M	08/27/2009	Initial information received on 19 August 2009 from another manufacturer whose initial reporter was a health care professional. A male patient received an influenza vaccine (manufacturer not known) over 20 years ago. Following administration the patient developed Guillain Barre Syndrome. No further information was provided. List of documents held by sender: none.				Y										UNK	UNK					200903604	1						1	Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0356003	08/31/2009	IN				U	08/27/2009	Initial report was received 19 August 2009 from another manufacturer (doc number 45223759), who received the report from a health care professional. A patient (demographics not reported) had received an Influenza vaccine (manufacturer and lot number not reported) in 2002 and an unspecified amount of time later, the patient may have developed Guillain Barre Syndrome. According to the reporter, the patient was treated at the hospital at that time. No additional information was provided at the time of the report. Documents held by sender: None.					Y								Not reported	UNK	UNK			Not reported		200903606	1						1	Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0356054	08/31/2009	TX	4.0	4		M	08/31/2009	Swollen red left arm. hot sensation with pain									U	08/28/2009	08/30/2009	2		PVT	PUB	none	none	unknown			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	DTPIPV~SANOFI PASTEUR~ac20b115aa~UNK~IM~RA~DTP + IPV (NO BRAND NAME)~1|FLUX~SANOFI PASTEUR~500673p~UNK~PO~MO~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~ahavb286aa~UNK~IM~LA~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0215y~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0055y~UNK~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0356057	08/31/2009	NY	31.0	31		F	08/31/2009	Sore and numbness in arm 8 hours after vaccination, lasting 3 days. Sore throat, body aches, headache and mild fever 24 hours after vaccination lasting 4 days. Strep test performed with negative results. Patient was given Motrin to relieve mild fever, body aches and headache.  Extreme fatigue set in 8 hours after the vaccination and lasted 4 days.				Y					Y	08/27/2009	08/27/2009	0	Strep test negative.	PVT	UNK	Plaquenil - 400mg daily, Celebrex - 200mg as needed	Patient has a history of, and is currently being treated for, mixed connective tissue disease.  The patent takes 400 mg of Plaquenil daily and has recently completed a round of IV steroids to suppress a current flare.	Pre-existing: Mixed Connective Tissue Disease; Allergies: Penicillin, Demoral			1						1	Fatigue; Headache; Hypoaesthesia; Oropharyngeal pain; Pain; Pain in extremity; Pyrexia; Streptococcal identification test negative	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~Arm~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0356064	08/31/2009	AR	6.0	6		M	08/31/2009	Within an hour after receiving immunization child broke out in rash that covered his trunk and extremeties.  Was given benadryl and rash began to clear.									Y	08/28/2009	08/28/2009	0	None	PVT	PVT	None	None	None			1						1	Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500675P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356066	08/31/2009	MN	36.0	36		F	08/31/2009	Flu shot received 08/24/09 @ 10:30 a.m. Sore throat developed that evening @ approx. 8:30 p.m. Developed headache, body aches, and low-grade fever (99.4F)on 08/25/09. All symptoms resolved after 3 days.				Y					Y	08/24/2009	08/24/2009	0	none	PUB	PUB	Prozac	none	depression			1						1	Headache; Oropharyngeal pain; Pain; Pyrexia	FLU3~CSL LIMITED~05749111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0356068	08/31/2009	TN	32.0	32		M	08/31/2009	swelling of lower lip, soreness of throat, and itching on Left forearm and left bicep									U	08/29/2009	08/29/2009	0	N/A	MIL	MIL	NONE		NONE KNOWN	NONE~ ()~NULL~~In Patient|NONE~ ()~NULL~~In Sibling1|NONE~ ()~NULL~~In Sibling2		1						1	Lip swelling; Oropharyngeal pain; Pruritus	FLUN3~MEDIMMUNE VACCINES, INC.~500685P~5~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356079	08/31/2009	IN	29.0	29		F	08/31/2009	Patient complains of severe pain in arm the injection was given.  Shootin pain all the way down her arm to fingertips.									Y	08/31/2009	08/31/2009	0		UNK	PVT		None	None	None~ ()~NULL~~In Patient		1						1	Pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA261AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0356080	08/31/2009	KS	62.0	62		F	08/31/2009	chills, sweats, body ache, difficulty sleeping									Y	08/27/2009	08/28/2009	1		UNK	UNK						1						1	Chills; Hyperhidrosis; Insomnia; Pain	FLUX~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0356089	08/31/2009	CA	63.0	63		M	08/31/2009	Fever to 103 F with shaking chills day after vaccination. Also warmed patch (10cm) anterolateral arm that has not resolved.									Y	08/28/2009	08/29/2009	1	None	PVT	PVT		None	Bad reaction to smallpox vaccine			1						1	Chills; Erythema; Pyrexia; Skin warm; Tremor	FLU3~SANOFI PASTEUR~U3176FA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~062BY~1~IM~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0356092	08/31/2009	CO	9.0	9		F	08/31/2009	VARIVAX administered 8/28/09 to Rt arm. Saturday, Pt woke with baseball size redness to vaccine site. C/o small amount of itching and mild redness. Denies pain or fever. Pt has full ROM of arm. Pt was not seen by physician, no lab work. Ice applied.									Y	08/28/2009	08/29/2009	1		PVT	PVT				Redness~Smallpox (no brand name)~1~34.00~Sibling		1						1	Injection site erythema; Injection site pruritus	FLUN3~MEDIMMUNE VACCINES, INC.~500681P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB357CA~2~IM~RA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~0126Y~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0356100	08/31/2009	IN	20.0	20		F	08/25/2009	Fever 100.4, chills, H/A, swollen lips, pains & tingling in arms/legs.  Treated with BENADRYL 25 mg PO and TYLENOL 1000 mg PO.									Y	08/24/2009	08/25/2009	1	Quick flu negative	PVT	PVT	Birth Control - type unknown	None	None			1						1	Chills; Headache; Influenza serology negative; Lip swelling; Pain in extremity; Paraesthesia; Pyrexia	DTP~SANOFI PASTEUR~UF551AA~UNK~IM~RA~DTP (NO BRAND NAME)~1|FLU3~CSL LIMITED~05649111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0356104	08/31/2009	IN	1.34	1	.3	F	08/24/2009	Mild case of chicken pox.				Y					N	01/20/2009	08/20/2009	212		PVT	PUB		None	None			1						1	Varicella post vaccine	FLU3~SANOFI PASTEUR~UT27886A~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~M0811X~1~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~M1281X~1~UN~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0356215	09/01/2009	AR	35.0	35		M	08/31/2009	On 27 April 2009 he received AVA #2 to left deltoid. He again experienced site burning and soreness. Within 6-8 hours he was awakened from sleep with diffuse muscle aches, nausea and a headache. He was able to return to sleep. Within 12 hours post vaccination (28 Apr 09) he awoke complaining of paresthesia to lateral aspect of his right knee extending anteriorly down calf to dorsum of right foot (along L5 nerve pattern). He described this paresthesia as pins and needles or a buzzing sensation with no weakness or loss of sensation. He had been in the gym and undergoing physical therapy (PT) for lower back pain and attributed this discomfort to his exercises. 29 April 2009 (day 2) he awoke with paresthesia to both right and left lateral lower legs (L5 distribution pattern as above R>L) down to dorsum of both feet with lower back pain (3/10). He used MOBIC for pain with minimal relief. About day 4 he denied any myalgia, headache or nausea, but he was treated with a MEDROL dose pack for persistent paresthesia with partial relief (eased but did not eliminate). May 2009 PT notes report improvement in LBP (2/10) with traction treatment and decrease in numbness/tingling in right lateral calf and foot; however patient stated he stopped traction because symptoms were worse. 2009 Neurological examinations were normal. Review of Sept-Oct 2008 c-spine x-rays and MRI documented C5-7 central canal stenosis and degenerative disc disease and facet arthritis. (No lumbar studies available - was in theater). Paresthesia complaints persisted unchanged (denied numbness or weakness) until 04 July 2009 when he awoke with a strong stiff neck pain that he could not stretch out. O5 July 2009 he noted first bilateral upper extremity paresthesia (numbness and tingling) along ulnar nerve-C8 distribution pattern and later perineal-perianal tingling (no bowel-bladder incontinence) with spastic feelings in feet. Neck pain and bilateral upper extremity paresthesia worsened with flexion and extension of neck (such as bending over patients intubating or doing other procedures). 09 July 2009 exam noted 2 beats clonus bilaterally with L>R UE paresthesia. Spinal surgeon suspected central HNP, provided MEDROL dose pack and medevaced him to back. Patient advised genital paresthesia resolved within 1 1/2 weeks after using MEDROL with marked decrease in UE/LE paresthesia. However extremity paresthesia did not fully resolve. As of 11 Aug 2009, he continues to experience moderate to severe neck > lower back pain described as a stiff annoying aching (5/10) discomfort to posterior neck region. He has infrequent paresthesia at rest, experiencing paresthesia to all four extremities mainly with lifting and stretching. His paresthesia occurs with the pain and is described as a burning feeling lasting 30 seconds. His SF36 identified limitations with vigorous activities (running, lifting heavy objects) and with climbing several flights of stairs, kneeling, bending or stooping due to pain (not paresthesia).				Y					Y	04/27/2009	04/27/2009	0	Neurology (17 Sept 2009) diagnosed post-vaccination myelitis which was slowly resolving. Reflexes were all normal and he anticipated full resolution over time. Lab studies from July 2009 were normal (homocysteine, methylmalonate, vit B12/folate, HLA-B27 (neg), FT4, protein electrophoresis, reagin Ab, HgA1c, endomysial Ab panel, ESR, Mg, TSH, nuclear Ab screen, triiodothyronine free, and non-reactive Treponema pallidum)[[address]]head - normal; MRI brain - normal but noted a 1.0 cm AP x 0.4 cm thick x 1.0 cm craniocaudal focus of increased T1 and decreased T2 signal within the anterior falx cerebri, most likely a [[name]] dural calcification. MRI cervical, thoracic and lumbar spine were compared to Oct 2008 were unchanged - overall normal with mild degenerative changes and stenosis at C5-6 and C6-7 with minimal DDD and facet arthritis. There was no evidence of demyelinating disease to the cord. There was multifactorial lumbosacral disease with severe facet arthropathy causing bilateral stenosis and no evidence of cord demyelination.	MIL	MIL	none	none	none			1						1	Activities of daily living impaired; Antibody test negative; Antinuclear antibody negative; Arthritis; Back pain; Blood homocysteine normal; Burning sensation; Discomfort; Electrophoresis protein; Free thyroxine index normal; Glycosylated haemoglobin; HLA marker study; Headache; Hypoaesthesia; Injection site pain; Laboratory test normal; Musculoskeletal stiffness; Myalgia; Nausea; Neck pain; Nuclear magnetic resonance imaging brain normal; Nuclear magnetic resonance imaging normal; Osteoarthritis; Paraesthesia; Red blood cell sedimentation rate normal; Scan brain; Syphilis test negative; Tri-iodothyronine free normal; Vitamin B12 normal	ANTH~EMERGENT BIOSOLUTIONS~FAV141~2~ID~LA~ANTHRAX (BIOTHRAX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA197AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1|TYP~SANOFI PASTEUR~B0347~UNK~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0356216	09/01/2009	VA	37.0	37		M	08/27/2009	This 37 year old officer received an annual FLUMIST administration on 05 October 2006.  (records receipt of both IM and nasal influenza;  however pt advises he received nasal).  Two prior vaccinations with intramuscular Influenza (2002-2003) resulted in no remembered adverse events.  Within 12 hours following his October 5th FLUMIST he began to experience low grade fevers lasting 12-24 hours.  No other adverse events were remembered.  Other vaccinations received after FLUMIST included TYPHOID vaccine and a PPD skin test on 23 October 2006.  Approximately 25+ [[name]]s FLUMIST (@ 30 October 06) and 6 [[name]]s post TYPHOID vaccination with a negative PPD reading he went to city (Oct 29-Nov 1, 2006) with his family on vacation.  While there he noticed a mosquito like bite  to his left elbow/forearm region.  He described a [[name]] circular bump 1-2cm in size, pinkish coloration that was mildly pruritic.  There was no identifiable [[name]].  It lasted a few hours to a few [[name]]s resolving spontaneously without medication.  This bump would reoccur a few times a week with satellite bumps that radiated to his waist/stomach (initially waist band area then al over), inner thighs, groin, back, and down lateral sides under axilla bilaterally.  He thought he was having a reaction to some soap, detergent, or deodorant, etc following his recent vacation and changed deodorants, detergents, etc without resolution.  He began to notice red raised confluent hives described up to 2 inches in diameter.  About Nov 1-2, 2006 he awoke with pruritic hives covering his body.  He denied any respiratory distress or problems swallowing and began BENADRYL 50 mg for 2 [[name]]s with resolution of the hives after the first dose.  Attempts to discontinue BENADRYL resulted in reoccurrence of hives so he began routine use three times a [[name]].  By 13 Nov 2006 while working, his hives worsened and he was treated by Dr with a diagnosis of urticaria/hives.  He was placed on ALLEGRA x 1 week with initial good response with reoccurrence of symptoms one week later.  In December 2006 he was referred to Dr, allergist at agency and placed on ZYRTEC.  He reported one episode of facial angioedema on 15 Dec 2006 and was seen in the emergency room at Hospital.  He was given a 5 [[name]] course of oral PREDNISONE with resolution of symptoms.  He was re-evaluated by Dr. on 18 Dec 2006 without change status (hives resolved if on ZYRTEC otherwise present).  12 Feb 2007 his initial evaluation by Dr, allergist at agency diagnosed idiopathic urticaria of unknown etiology.  Dr could not rule out autoimmune component (l.e. anti -Fc epsilon RI antibody).  He was referred to the Center for follow up evaluation on possible association of rash after FLUMIST vaccination.  A follow up interview on 21 Feb 2007 reported this service member had tried stopping ZYRTEC during a recent 3 [[name]] long weekend with the rash/hives returning to his inner thighs as itching then 1 inch hives which progressed up abdomen with arms having [[name]] red raised bumps.  Symptoms resolve within a few hours after taking 10 mg ZYRTEC orally and remain well controlled on ZYRTEC.  Follow up evaluations with Dr identified elevated TSH 5.08 (0.27-4.20), thyroglobulin Ab 53 (0-20) and thyroperoxidase 537 (0-35);  normal FT4 and abnormal ESR 66 (1-19).  A diagnosis of idiopathic urticaria with mild CIU and possible hypothyroidism trigger:  and hypothyroidism was electrophoresis, and CRP levels.  Repeat ESR, TSH, & FT4 were all normal.  Subsequent evaluations from 2007-2009 reported resolution of rash with treatment for hypothyroidism with synthroid.  On 07 Nov 2008 he received IM influenza with no adverse events reported (no rash).  Symptoms:  Lesions, papule, Rash, pruritic, Erythema.				Y					Y	10/05/2006	10/30/2006	25	2007, elevated TSH 5.08 (0.27-4.20);  Thyroglobulin Ab 53 (0-20) and thyroperoxidase 537 (0-35);  normal FT4 and abnormal ESR 66 (1-19).  Further lab studies included normal C3d;  Nuclear Ab panel;  C1qAg binding;  Protein electrophoresis and CRP levels.  Repeat ESR, TSH, & FT4 were all normal.	MIL	MIL	None	None	None			1						1	Angioedema; Anti-thyroid antibody positive; Antinuclear antibody negative; Blood thyroid stimulating hormone increased; C-reactive protein normal; Complement factor C3; Electrophoresis protein normal; No reaction on previous exposure to drug; Pruritus; Pyrexia; Rash; Rash erythematous; Red blood cell sedimentation rate increased; Thyroxine free normal; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0356222	09/01/2009	VA	60.0	60		F	08/26/2009	24 hours after receiving vaccine, began to feel bad.  Muscle ached.  Large red rash appeared and is still visible 5 days later, although it seems to be diminishing.  Still very dizzy.									N	08/21/2009	08/22/2009	1		UNK	PVT		None	None			1						1	Dizziness; Feeling abnormal; Myalgia; Rash erythematous	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~~UNK~UN~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0356225	09/01/2009	WI	12.0	12		M	08/27/2009	Passed out. Stomach pain.									Y	08/27/2009	08/27/2009	0		PVT	UNK				Yes~Meningococcal Conjugate (Menactra)~1~12.00~Sibling|Yes~Influenza (Seasonal) (FluMist)~1~12.00~Sibling		1						1	Abdominal pain upper; Loss of consciousness	FLUN3~MEDIMMUNE VACCINES, INC.~500675P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U2688AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0356233	09/01/2009	WI	12.0	12		M	08/27/2009	Passed out.  Stomach pain.									Y	08/27/2009	08/27/2009	0		PVT	PUB				Yes~Meningococcal Conjugate (Menactra)~1~12.00~Sibling|Yes~Influenza (Seasonal) (FluMist)~1~0.00~Sibling		1						1	Abdominal pain upper; Loss of consciousness	FLUN3~MEDIMMUNE VACCINES, INC.~500675P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U2688AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0356242	09/01/2009	MO	73.0	73		F		Dizziness (within 10 minutes of FLU vaccine admin.).  Fainted (between 10-15 minutes of administration).  Paramedics said that the patient had an episode of seizure.  Pt had a history of seizure (last time: 10 years ago).				Y					Y	09/01/2009	09/01/2009	0	D F/U w/pt 7:20 pm - She's doing well; said it wasn't seizure.	OTH	PUB	Unknown	None	Seizure (10 yrs ago).			1						1	Condition aggravated; Convulsion; Dizziness; Syncope	FLU3~SANOFI PASTEUR~U318AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0356243	09/01/2009	NE	5.0	5		M	09/01/2009	Erythema multiforme within 24 hours of receiving shots.				Y					N	08/31/2009	09/01/2009	1	none	PVT	PVT		none	environmental allergies			1						1	Erythema multiforme	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B137AA~UNK~IM~RL~DTAP + IPV (KINRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500673P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~MERCK & CO. INC.~0708Y~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0865Y~2~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0356248	09/01/2009	DE	4.0	4		F	09/01/2009	Mother reported high fever and frontal headache the night of receiving the listed vaccines. Mother reported fever resolved but headache remained the following morning.									Y	08/31/2009	09/01/2009	1	None	PVT	PVT	none	None	None			1						1	Headache; Pyrexia	DTAP~SANOFI PASTEUR~03147AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~63176CA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~D0304~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0356251	09/01/2009	IL	32.0	32		F	09/01/2009	Symptoms of feeling overheated, tachycardia and shortness of breath began approximately one hour after receiving vaccine. Emergency room administered nebulizer treatment, ZYRTEC, PEPCID, and BENADRYL.				Y					Y	08/31/2009	08/31/2009	0	Emergency room-physician assessment	PVT	PVT	Pre-natal vitamins; SYNTHROID	none	NKA; hypothyroidism; 1st trim. pregnancy			1						1	Dyspnoea; Feeling hot; Tachycardia	FLU3~SANOFI PASTEUR~U3196AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0356252	09/01/2009	IL	78.0	78		F	09/01/2009	After receiving her shots pt c/o shortness of breath. She recovered on her own before paramedics arrived.									Y	08/31/2009	08/31/2009	0		OTH	OTH	ADVAIR; SPIRIVA	COPD	COPD			1						1	Dyspnoea	FLU3~SANOFI PASTEUR~U3187AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1162X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0356261	09/01/2009	OH	6.0	6		M	09/01/2009	Developed hives around injection site less than 24 hours after given.									U	08/31/2009	09/01/2009	1	Food allergy testing drawn on 8/31/09.	PVT	PVT	Flovent,Albuterol	None	Asthma			1						1	Allergy test; Injection site urticaria	FLU3~SANOFI PASTEUR~U3204AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356267	09/01/2009	VA	8.0	8		F	09/01/2009	Received Hep A and Flumist, left room and pt. became diaphoretic, fell at hit front of head, seized and was transported to ER.				Y					U	09/01/2009	09/01/2009	0	CT scan	PVT	PVT	none	no	none	none~ ()~NULL~~In Patient|none~ ()~NULL~~In Sibling1|none~ ()~NULL~~In Sibling2		1						1	Computerised tomogram; Convulsion; Fall; Head injury; Hyperhidrosis	FLUN3~MEDIMMUNE VACCINES, INC.~500677P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~1027V~2~IM~LA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0356283	09/01/2009	NC	48.0	48		F	09/01/2009	Approximately 10-12 hours after receiving the vaccine, I developed flu like symptoms-fever, chills, nausea, muscle and joint pain.  I also developed some upper respitatory symptoms as well-stuffy nose primarily.  I went to see my family physician and they performed a flu nasal swab test, CBC, and urinalysis.  These all came back normal or negative for any disease process.  I was told to go home and take Tylenol/Ibuprofren q.6 hours and to rest.  I did so, and am feeling better this evening.									Y	08/31/2009	09/01/2009	1		UNK	UNK	Paxil, Flax seeds-1 TBSP ground, Vitamin D, Caltrate, Ambien CR, Simvastatin, Tetracycline and Keppra	NONE	Allergies to PCN and Bactrim			1						1	Arthralgia; Chills; Influenza like illness; Myalgia; Nasal congestion; Nausea; Pyrexia; Respiratory disorder	FLU3~SANOFI PASTEUR~U3209AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356287	09/01/2009	CA	74.0	74		F	09/01/2009	pt recevied flu shot on left arm,and pneumovax ,and decavac on the right arm at 11 am on 8/28/09.the next day,she called ,and complained that she had pain on right arm,and it is not rotatable.she can not lift the arm.We called her on 8/30/09,and 8/31/09 .she said that she was getting better									Y	08/28/2009	08/28/2009	0		UNK	UNK		none	none			1						1	Injected limb mobility decreased; Pain in extremity	DT~SANOFI PASTEUR~u2862aa~2~IM~LA~DT ADSORBED (DECAVAC)~1|FLU3~SANOFI PASTEUR~u3198aa~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1161x~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0356288	09/01/2009	VA	61.0	61		F	09/01/2009	Her whole arm(on which vaccine was administered) was inflammed and swollen and she developed a rash within 1-2 days. She also had a mild temperature the day after vaccination and reported that she did not feel better. However the temperature subsided in a day. The rash was bothering her and so she decided to visit a walk-in clinic and she was daignosed with cellulitis. She was given antibiotic (IV) in the clinic and was prescribed a course of oral antibiotic also.				Y					Y	08/24/2009	08/25/2009	1		UNK	UNK		none				1						1	Body temperature increased; Cellulitis; Inflammation; Oedema peripheral; Rash	FLU3~SANOFI PASTEUR~v1371AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0024y~1~IM~RA~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~0722y~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0356290	09/01/2009	CA	30.0	30		M	09/01/2009	Vertigo and stomach cramps beginning ~24 hours after injection and lasting for ~2 hours. Second bout of vertigo ~72 hours after injection, which is still continuing.									N	08/29/2009	08/30/2009	1		UNK	UNK	fluoxetine, finasteride, loratadine, famitodine					1						1	Abdominal pain upper; Vertigo	FLUX~SANOFI PASTEUR~U3203AA~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0356295	09/01/2009	NE	2.0			M	08/18/2009	A serious, spontaneous report of medication error, bronchospasm and exacerbation of asthma has been received from a physician concerning a two-year-old male patient subsequent to FLUMIST administration.  Medical history included asthma.  The patient was not taking concomitant medications.  On 10-Aug-2009, the patient received FLUMIST.  On 11-Aug-2009, the patient developed bronchospasm and was admitted to the hospital.  The diagnosis was exacerbation of asthma.  On 12-Aug-2009, the patient was discharged from the hospital.  The outcome of the events, bronchospasm and asthma exacerbation was resolved.					Y	0			Y	08/10/2009	08/11/2009	1		PVT	OTH	Concomitant Drug(s) Not Reported	Asthma			MEDI0008788	1						1	Asthma; Bronchospasm; Condition aggravated; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~500677P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0350543	09/02/2009	CA	14.0	14		F	09/01/2009	Information has been received from a consumer concerning her 14 year old daughter with no medical history or drugs allergies, who on 22-OCT-2007 was vaccinated with a 0.5 mL dose of GARDASIL, intramuscularly. Concomitant therapy included fludrocortisone, ZOFRAN, an unspecified antibiotic, a patch for pain, doxycycline, zaleplon, VALIUM and VICODIN. Forty-eight hours after the vaccination the patient experienced pain in her legs. She also blacks and had dizziness, fatigue, migraines, body spasms, joint pain, weakness, memory loss, difficulty speaking and difficulty concentrating on things. She had loss about 30 pounds because of really bad nausea. When she stands up she gets a real loud ringing in her ears. She had abdominal pain and sensation of burning throughout her body. She had a rash all over her body and she was constantly itching. She gets chest pains. She was constipated and it was really hard for her to urinate. It was hard for her to stay awake. She had been to the emergency room more than 20 times. She was admitted to hospital 3 times. Therapy with GARDASIL was discontinued. All the laboratories tests (unspecified) performed to the patient have come back normal. At the time of this report the patient had not recovered. Follow up information received on 27-AUG-2009 from the physician's office supervisor indicated that the patient was vaccinated with a dose of GARDASIL (lot # 658563/1063U) IM on 22-OCT-2007. Concomitant vaccination given on 22-OCT-2007 included a dose of influenza virus vaccine (lot # U2486AA). The supervisor stated that the patient had not been seen in their office since October 2007. The reporter also indicated that the patient was referred to a rheumatologist. On 28-AUG-2009 information was received from a registered nurse from the office of a pediatric neurologist who reported the following highlights for the patient: the patient has many chronic conditions. She was last seen in their office on 14-APR-2008. Dates for the three hospitalizations were: 19-JUL-2008 to 29-JUL-2008; 10-OCT-2008 to 12-OCT-2008; 06-MAY-2009 to 10-MAY-2009. Some of the diagnoses listed in the discharge summaries included fibromyalgia (onset 2007), Lyme disease (onset 2008), Epstein Barr virus (onset March 2009), and migraine headaches (onset 2007). A brain CT performed on 09-OCT-2008 was normal. Some of the many treatment medications the patient received included naproxen for pain, doxycycline for Lyme disease, ZOFRAN and ZANTAC for GI problems. The patient was seen by several specialists including rheumatology, neurology, psychiatry, hematology. The conditions were considered disabling at times, but not life-threatening. No further information is available.  Follow-up: Our daughter has multiple symptoms. She is on pain medication monitored by a pain management doctor she has extreme skeleton pain in her legs and joints to the point where she cries all the time. She has been hospitalized 3 times and has had over 20 emergency visits she has eye strain headaches spots in eyes she has low blood pressure and always cold, she can't sleep because of her pain and has stayed a wake for days, and then she has episodes of not waking up and stays in bed for days. She has not attended school for 3 years except for the occasional 1 to 2 hour class. She blacks out and my wife has to sleep with her she cant be left alone, recently she was walking around our house because of her pain and sleeplessness she was with a friend she had a seizure and he called paramedics they responded and said if she was sleeping she would have died in her sleep she was treated at the ER and saw a neurologist and was put on anti seizure medicine she has unexplained bruising and rashes she can't digest normal food and has extreme constipation and has difficulty urinating skin to sensitive to touch we are a family in crisis we contacted Merck and made a file but nobody contacted us after reading about all the kids affected by this and the pretence that there is no connection to GARDASIL its laughable. We concluded big business taking care of its bottom line not the human beings its infected. They say that every claim is investigated well I can assure they are not nobody contacted us. Our daughters life and ours had been turned upside down and no end insight we only did this because of all the advertising and we saw the surgeon general on TV he said on advertisement as soon as his daughter was of age she would get the shot its anti cancer the C would it's a miracle drug it's a nightmare drug and we were sucked in the by the aggressive misleading adds it worked. The tears sleepless night the destruction of our daughter and our family is inexcusable somebody needs to go to jail!!!!!!!!!!!!. The lies being told that there is no connection and everyday more kids will succumb, for the bottom line of big business if Toyota and BP got found out why can't somebody open there eyes and say enough stop this until it can be explained. The system is broke and our children are being destroyed and or dead. What does it take for awake up call this is not the stock market or the banks this is human beings banks can be funded stocks can recover what about the lives of our children who can't repair the damage we don't know what the further holds but somebody needs to take responsibility before more children lives are destroyed. All I seem to do is run into brick walls. The doctors don't know how to treat her we have  been to every type of doctor every ologist there is and they all throw up there hands and say we don't know what's wrong Merck knows and should be forced to help but that means admitting they screwed up and that relates to dollars so here we are everybody hiding from the truth because of there own personnel damage control a very distraught parent who has lost his normal life my daughter was never sick now we live in doctors offices searching for answers and help with very little faith in the system and the government and Merck we have a huge book of tests and medicines and we just want our daughter back to normal and our lives you can not imagine the damage that has been done to this family. I hope this letter does not fall on stoney ground or deaf ears. We have so much information from tests if it will help. Why has there not been a investigation to help us by giving us a doctor who has knowledge of the drugs side effects and how to treat this nightmare every doctor we have seen in the dark Merck has information how were the patients in the clinical trials treated. Also why did they use the ingredients in the placebo? ?? This allowed the reaction levels to be false. An American family in mental anguish and financial devastation I refuse to accept that we are an acceptance percentage. If it was their daughter??? How many of Mercks people have had the shot now that it is obviously a problem??????. A tax paying American citizen looking for answers and help.				Y	Y			Y	N	10/22/2007			Unknown	OTH	OTH	VICODIN; antimicrobial (unspecified); VALIUM; doxycycline; fludrocortisone; ZOFRAN; zaleplon		None		WAES0908USA04104	1						2	Arthralgia; Bedridden; Constipation; Disturbance in attention; Dyskinesia; Fatigue; Feeling abnormal; Headache; Hypotension; Loss of consciousness; Nausea; Pain in extremity; Rash; Syncope; Weight decreased; Abdominal pain; Activities of daily living impaired; Amnesia; Arthralgia; Asthenia; Asthenopia; Bone pain; Brain scan normal; Burning sensation; Chest pain; Computerised tomogram normal; Constipation; Contusion; Convulsion; Crying; Disturbance in attention; Disturbance in attention; Dizziness; Dyspepsia; Dysuria; Epstein-Barr virus infection; Fatigue; Feeling cold; Fibromyalgia; Gastrointestinal disorder; Hyperaesthesia; Hypotension; Insomnia; Laboratory test normal; Loss of consciousness; Lyme disease; Migraine; Muscle spasms; Muscle spasms; Nausea; Pain in extremity; Pruritus; Rash; Rash generalised; Scan brain; Scan brain; Sleep disorder; Somnolence; Speech disorder; Tinnitus; Visual impairment; Weight decreased; Weight decreased	FLU3~SANOFI PASTEUR~U2486AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1063U~1~UN~UN~HPV (GARDASIL)~1|FLU3~SANOFI PASTEUR~U2486AA~UNK~IJ~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|HPV4~MERCK & CO. INC.~1063U~UNK~IM~UN~HPV (GARDASIL)~2	USA	Hospitalisation,Disabling	Influenza
0356326	09/02/2009	PA	14.0	14		M	08/26/2009	None stated									Y	08/26/2009	08/26/2009	0		PVT	PVT		None	None			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U3189AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0604Y~1~IM~RA~HEP A (VAQTA)~1|MNQ~SANOFI PASTEUR~U2866AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~UF460BA~1~IM~LA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~0729Y~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0356329	09/02/2009	IL	25.0	25		F	08/28/2009	More than normal bleeding at time of injection (pt. not on blood thinners etc.) 5-10 min. after injection, arm felt asleep. About 30 minutes post-injection patient began to experience nausea, weakness and felt hot. These symptoms lasted about 30 minutes before patient began returning to normal. No treatment administered. (patient sat down).									Y	08/28/2009	08/28/2009	0	none	OTH	PVT	none	none	None			1						1	Asthenia; Hypoaesthesia; Injection site haemorrhage; Nausea; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0356350	09/02/2009	CO	56.0			U		Reported general malaise - Temp up to 102 degrees.									Y					OTH	PVT						1						1	Body temperature increased; Malaise	FLU3~SANOFI PASTEUR~U3196AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356351	09/02/2009	CO	80.0			U		Reported: Didn't feel good, shaky, anxious, palpitations, frequent urination, fecal evacuation.									Y					OTH	PVT		No	Sensitive to Latex			1						1	Anxiety; Bowel movement irregularity; Malaise; Palpitations; Pollakiuria; Tremor	FLU3~SANOFI PASTEUR~U3196AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356354	09/02/2009	TX	4.0	4		M	09/02/2009	Within 12 hours of flu shot injection the injection site was red, swollen, and heated.  After 24 hours, the entire upper arm and shoulder were affected similarly.  Hives formed under around the injection site, under the injected arm, and spread down the torso from the underarm.  Hives were limited to the injected arm until 72 hours after injection, when they spread to the rest of the body.  A low-grade fever was present for a few hours the morning after injection.  96 hours after injection, the swelling and redness at the injection site has resolved.  The hives and itchiness remain.  Treatment has been limited to Benadryl and topcial cortisone cream for the hives.  The patient is allergic to amoxicillin and cephalosporins.  He has had prior flu injections in 10/05, 11/05, 11/06, and 11/08 with no reaction.									U	08/28/2009	08/29/2009	1		PVT	UNK	Azithromycin	ear infection	Amoxicillin, cephalosproins			1						1	Injection site erythema; Injection site swelling; Injection site urticaria; Injection site warmth; No reaction on previous exposure to drug; Pruritus; Pyrexia; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0356356	09/02/2009	MN	56.0	56		F	09/02/2009	At the time of the vaccination, she felt a burning sensation down to her wrist, daily pain with radiation of pain down back and neck. Site never got red or swollen. She felt that the placement of the vaccine was placed too high on her shoulder area.									U	08/12/2009	08/12/2009	0		PUB	UNK	coumadin, sertraline, albuterol, singular	none	Leiden Factor			1						1	Back pain; Burning sensation; Neck pain	FLU3~CSL LIMITED~02149211a~7+~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0356358	09/02/2009	AL	59.0	59		F	09/02/2009	Employee developed large welped, reddened area from top of left deltoid extending down to mid-biceps area and around back of arm but not circumferencing the upper arm. Employee had significant pain associated with the edema.				Y					Y	08/31/2009	09/01/2009	1	na	UNK	UNK	Singulair, Premarin, Advair Norvasc, Demadex	no	asthma, COPD, hypertension, anemia			1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site urticaria	FLU3~SANOFI PASTEUR~U3204AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0356361	09/02/2009	IN	43.0	43		F	09/02/2009	Received shot in clinic around 2:00 p.m.  Around 4:00 p.m. my eyes started burning and felt like I had sand in them - by the time I got home at 5:30 p.m. they were very runny - producing a lot of sleep that required me to wipe them off about every 20minutes or so.  Also about 5:30 - the soft pallet under my tongue began to swell up.  From 5:30 - 7:30 I ran the entire course of flu symptoms with fever (99/100) chills, aches, nasaue in addition to the eyes and swollen tongue.  Took a benedryl which relieved the symptoms of the swelling and the eyes running as much.  Today - I ended up taking another benedryl because my tongue felt as if it was swelling up again.  Other than that and some minor eye irritation still today I feel better. I am not allergic to eggs at all and have never had any previous issues with flu shots.									Y	09/01/2009	09/01/2009	0	N/A	PUB	UNK	Prozac - daily vitamin	None that I was aware of	N/A			1						1	Chills; Eye discharge; Eye irritation; Influenza; Nausea; No reaction on previous exposure to drug; Pain; Pyrexia; Swollen tongue	FLUX~UNKNOWN MANUFACTURER~Not available~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0356362	09/02/2009	VA	41.0	41		F	09/01/2009	Patient experienced wheezing and chest tightness 2 hours after receiving the flu vaccine 8/31/09.  She has not felt well since this episode began and today, 9/1/09, she experienced nausea, stomach cramping and feeling like she needed to go to the bathroom. She fainted while in the bathroom.  She woke up sweating, clammy and very weak.  BP 104/60, BS 132 (1 1/2 hours after eating).  She has a history of hypertension, history of hay fever but no other medical problems nor history of an adverse event to vaccine administration.  No one in her family has history of an adverse event after vaccine administration.  She has been taken to a doctor here in town for evaluation.  She received FLU-CSL 0.5 ml IM left deltoid.				Y						08/31/2009	08/31/2009	0		PUB	PUB		None	Hypertension, Hay Fever			1						1	Abdominal pain upper; Asthenia; Chest discomfort; Cold sweat; Defaecation urgency; Hyperhidrosis; Malaise; Nausea; No reaction on previous exposure to drug; Syncope; Wheezing	FLU3~CSL LIMITED~01849211A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0356369	09/02/2009	MI	54.0	54		F	09/02/2009	Induration and redness/swelling in area where injection given. Warm to touch.Arm sore above and below area where injection given.									Y	09/01/2009	09/01/2009	0	None	PUB	PVT	NA		Cardiac disease, Adult Onset Diabetes			1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth; Pain in extremity	FLU3~SANOFI PASTEUR~U3209AA~1~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356385	09/02/2009	AK	56.0	56		F	09/01/2009	Patient was given 0.5 mL of flu vaccine on 8-31-09. On the afternoon of 9-1-09, patient came to me with a red, hot to touch spot on left arm. Area is 3inches wide and 2inches long.  Pt did warm compresses.									Y	08/03/2009	09/01/2009	29	None	PVT	PVT	SYNTHROID	None	None			1						1	Erythema; Oedema peripheral; Skin warm	FLU3~CSL LIMITED~05649111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0356386	09/02/2009	CO	12.0	12		F	09/12/2009	Pt given flu shot (told to hang around store for approximately equal to 10 minutes for signs or symptoms of allergic reaction). Patient and her mother returned in five minutes, they said she fainted and bumped her head on the ground. She didn't remember exactly what happened, but I gave her an ice pack and she sat down as help (911) notified. She left before EMS arrived. However, she said she felt fine other than the bump on her head. Later, called (Incident 3:50 PM) 6:50 PM, and spoke w/ pt who said she felt fine.									Y	09/02/2009	09/02/2009	0		OTH	PVT	Unknown		Unknown			1						1	Fall; Head injury; Syncope	FLU3~SANOFI PASTEUR~U3190AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356389	09/02/2009	OR	51.0	51		F	09/02/2009	Redness, warmth in shoulder and spreading across upper torso. Also implied that she was diagnosed with pneumonia as a result of vaccinations.				Y					U	08/31/2009				OTH	PUB						1						1	Erythema; Pneumonia; Skin warm	FLU3~SANOFI PASTEUR~U3198A~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB140AA~1~UN~RA~HEP A + HEP B (TWINRIX)~1|PPV~MERCK & CO. INC.~1124X~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0356395	09/02/2009	CA	3.0	3		M	09/02/2009	Erythema, edema, hyperemia measuring 10 x 12 cm on deltoid area.				Y						08/01/2009	08/01/2009	0		PVT	PVT						1						1	Erythema; Hyperaemia; Oedema	DTAP~SANOFI PASTEUR~C3141AA~5~UN~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U3174EA~5~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~D0039~4~UN~LA~POLIO VIRUS, INACT. (IPOL)~1|VARCEL~MERCK & CO. INC.~0726Y~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0356396	09/02/2009	TX	7.0	7		F	09/02/2009	Cough, runny nose congestion sneezing fever off and on x 3wks. Albuterol solution 0.083%.				Y					Y	08/15/2009	08/16/2009	1	None	PVT	PVT	None					1						1	Cough; Pyrexia; Respiratory tract congestion; Rhinorrhoea; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~500675P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0356400	09/02/2009	SC	1.3	1	.3	M	09/02/2009	Patient administered PCV, Hep A, and DTaP on 9/1/09. Within a few hours patient noted to have hive like rash on body. By 9/2/09, rash all over body. Reports same type reaction after 6 mos shots. No treatment other than BENADRYL.									Y	09/01/2009	09/01/2009	0	None, clinical	PVT	PVT	TYLENOL PRN	URI (viral); runny nose; sneezing	None			1						1	Rash generalised; Urticaria; Vaccine positive rechallenge	DTAP~GLAXOSMITHKLINE BIOLOGICALS~A14B100BA~4~IM~LA~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U3200AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAvb326AA~1~IM~RA~HEP A (HAVRIX)~1|PNC~PFIZER\WYETH~D39016~4~IM~RA~PNEUMO (PREVNAR)~1	USA		Influenza
0356410	09/03/2009	OR	18.0	18		M	08/28/2009	Edema of lips, red eyes, hives on arms, back of head, chest tightness. Patient took BENADRYL. Rx for prednisone taper.				Y						08/27/2009	08/27/2009	0		OTH	PUB	none	none	none			1						1	Chest discomfort; Lip oedema; Ocular hyperaemia; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~50067AP~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0356441	09/03/2009	MI	65.0	65		F	09/03/2009	Received Influenza and PPV23 vaccines on 08-31-2009. Began to have swelling and redness at injection site of PPV23 vaccine initially and then redness extended to below elbow and around entire arm. Has been putting cold compresses without releif. Arm is red, warm to touch and swollen extending below elbow .									U	08/31/2009	09/01/2009	1	None	PUB	PVT		No	COPD,Asthma,			1						1	Erythema; Injection site erythema; Injection site swelling; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U3209AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~Unknown~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0356444	09/03/2009	FL	20.0	20		M	09/03/2009	After receiving Hepatitis A vaccine patient fainted and had some seizure activity, including eyes twitching, tonic-clonic movements of arms and legs and stiffening of his back. Was unresponsive for approximately 1 to 2 minutes with seizure-like activity less than 1 minute. Upon recovery was oriented to person, time, place. Knew President of the U.S. (even though he recently arrived from another country) and knew how many dimes in a dollar. Refused transport to hospital by EMTs who did attend to patient.									Y	09/02/2009	09/02/2009	0	Vital signs were stable when responsive after incident, Accucheck 86.	PUB	PUB	N/A	N/A	Did report previous episodes of fainting and seizures with fever, injury and vaccine.			1						1	Blepharospasm; Blood glucose normal; Convulsion; Musculoskeletal stiffness; Syncope; Tonic clonic movements; Unresponsive to stimuli	FLU3~SANOFI PASTEUR~AHAVB309BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~U3207AA~1~IM~LA~HEP A (HAVRIX)~1	USA		Influenza
0356445	09/03/2009	PA	56.0	56		F	09/03/2009	began developing symptoms approx. 4 hrs. following administration of flu vaccine.  Began coughing,& having chest tightness.  Developed 101 temperature with chills and aches and reddened eyes.  Symptoms resolved next day except for reddened eyes.									Y	09/02/2009	09/02/2009	0	none	UNK	UNK	calcium 600 mg. bid	none	Penicillin	none~ ()~NULL~~In Patient		1						1	Body temperature increased; Chest discomfort; Chills; Cough; Ocular hyperaemia; Pain	FLU3~SANOFI PASTEUR~U3185AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356447	09/03/2009	AR	41.0	41		F	09/03/2009	Tightness in throat, radiating to chest, coughing, high blood pressure (173/109). Symptons began at 4:20pm and continued until steroid were administered in ER at 6:15 and 6:27pm.				Y					Y	09/02/2009	09/02/2009	0	N/A	PVT	UNK	Ortho-Cyclen	No	None	N/aA~ ()~NULL~~In Patient		1						1	Chest discomfort; Cough; Hypertension; Throat tightness	FLU3~SANOFI PASTEUR~U3253AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0356453	09/03/2009	NY	42.0	42		F	09/03/2009	The patient received the flu shot on 09/01/09 at 1450 and withtin 15-20 minutes she started having symptoms.  The patient complained of dizziness, lightheadedness, inability to concentrate.  The patient stated that she felt as if she was having an exacerbation of her MS.  The patient left work and went to see her neurologist.  Her doctor is now observing her Guillain-Barre.  10/21/09 Neurology consult records received service date 9/4/09. Assessment: Multiple sclerosis with flu vaccine-induced exacerbation. Patient complains of feeling poorly. Fever and chills, feeling foggy, unable to think straight, weak and dizzy. Burning in right leg worse.				Y					U	09/01/2009	09/01/2009	0	unknown	UNK	UNK	Rebif 22 mcg	NONE	Multiple sclerosis x 10 years; patient's disease has been well controlled. 10/21/09 Neurology consult records received service date 9/4/09. Multiple sclerosis. Burning sensation right leg. Asthma, shortness of breath due to flu shot. Itching due to codeine.			1						1	Disturbance in attention; Dizziness	FLU3~CSL LIMITED~02249211A~6~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0356468	09/03/2009	MI	51.0	51		F	09/03/2009	Pain in left tricep 1 hour following shot-over the course of 12 hours increasing severe muscle aches in joints, back, feet, shoulders, head,chest pains.  Severe shortness of breath for 2 days, coughing, wheezing, chills, fever (highest 101.4), sweats, insominia, dry heaves, extreme thirst, loss of appetite, fatigue.  a 8x11 hot, red, swollen, very painful left arm just above and including the left elbow area-injection area was hot but not red or swollen.  Went to urgent care and the dr. prescribed dexadron, medrol dose pak, and keflex for 10 days in addition to wearing a sling.				Y					N	08/31/2009	09/01/2009	1	Not yet-no tests	UNK	UNK	None	None	PCN, Fibromyalgia, osteopenia,	flu-like symptoms~Influenza (Seasonal) (no brand name)~1~49.00~Patient		1						1	Arthralgia; Chest pain; Chills; Cough; Decreased appetite; Dyspnoea; Erythema; Fatigue; Headache; Hyperhidrosis; Injection site pain; Injection site swelling; Injection site warmth; Insomnia; Musculoskeletal pain; Myalgia; Pain; Pyrexia; Retching; Thirst; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0356471	09/03/2009	CA	4.0	4		F	09/03/2009	DTap #5 administered to left Deltoid 9/1/09, upper arm became swollen/red very tight and painful. Taken to Emergency Room by mother 9/2/09 (as clinic was closed), where Prednisone was prescribed. Reaction resolved as stated by mother on 9/3/09.				Y					Y	09/01/2009	09/01/2009	0	none	PUB	PUB	none	none	none			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling	DTAP~SANOFI PASTEUR~AVB U2471CA~5~IM~LA~DTAP (DAPTACEL)~1|FLUX~SANOFI PASTEUR~U3190AA~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~MSD 1582X~4~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0356472	09/03/2009	AZ	41.0	41		F	09/03/2009	R Arm - site of injection swollen red and painful per patient. Swelling extends inot axilla,									U	09/01/2009	09/02/2009	1		PVT	PVT	Albuterol, Adderall, Symbicort	None	None			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U3189AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1086X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0356477	09/03/2009	CO	57.0	57		M	09/03/2009	Fever, chills, aches, hard to move, headache.									U	09/02/2009	09/02/2009	0		OTH	PVT		None	None			1						1	Chills; Headache; Hypokinesia; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U3196AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356479	09/03/2009	VA	12.0	12		M	09/03/2009	Received VARIVAX # 2 on 08/31/09, injection area has become red, swollen, painful, area of erythema, well circumscribed, slightly warm, mild pain & touch.  No streaking, no signs of infection.				Y					Y	08/31/2009	09/02/2009	2		PVT	UNK						1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLUN3~MEDIMMUNE VACCINES, INC.~500681P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~0929Y~UNK~SC~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0356485	09/03/2009	CA	5.0	5		M	09/03/2009	Vaccine 8/27/09 8/29/09 Urticaria swollen eyes, nose, lips.  Given EPINEPHRINE 0.15 mg IM and BENADRYL 12.5 mg orally.									U	08/27/2009	08/29/2009	2		PVT	PVT	None	None	None			1						1	Eye swelling; Lip swelling; Swelling face; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500691P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356488	09/03/2009	CA	4.0	4		M	09/03/2009	Small rash all body with no SOB or wheezing pulse OX 100% BENADRYL PO every six months.									Y	09/03/2009	09/03/2009	0		PVT	UNK		No				1						1	Oxygen saturation normal; Rash generalised	FLU3~SANOFI PASTEUR~43204AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356491	09/03/2009	IL	62.0	62		F	09/03/2009	Right arm hurts, patient says can't lift arm above the shoulder. Arm throbs, no swelling. After 2 hours post injection no swelling or redness of site - just soreness.									U	09/03/2009	09/03/2009	0	none	OTH	OTH	Amitriptyline; Levothyroxine; Fluoxetine; Naproxen; Simvastatin	None	None			1						1	Injected limb mobility decreased; Pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2A~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0356492	09/03/2009	IN	50.0	50		F	08/26/2009	Swollen, red, hot area - hard to move upper arm.									U	08/25/2009	08/25/2009	0		UNK	UNK		None	PCN; Seasonal allergies	same symptom~Td Adsorbed (no brand name)~UN~30.00~Patient		1						1	Erythema; Mobility decreased; Skin warm; Swelling	FLU3~SANOFI PASTEUR~U3192AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356494	09/03/2009	CO	3.0	3		F	09/03/2009	Fever - 103 degrees, stomach-ache, muscle aches.									U	09/01/2009	09/03/2009	2	None	PVT	PVT			None			1						1	Abdominal pain upper; Myalgia; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500675P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356497	09/03/2009	OR	51.0	51		U		Pt reports onset of fever, chills & all-over body aches on 8/30/09, injection was given 8/28/09.									Y	08/28/2009	08/30/2009	2		UNK	UNK		None	None			1						1	Feeling cold; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U3174EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356523	09/04/2009	FL	12.0	12		F	08/31/2009	Pt passed out while in hall after receiving vaccines.  Hit back of head- small 1/4  laceration.  Given juice to drink & allowed to recover with feet up.  Sent to ER for stitch eval.				Y					Y	08/31/2009	08/31/2009	0		PVT	PVT						1						1	Head injury; Loss of consciousness; Skin laceration	FLU3~SANOFI PASTEUR~U3190AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB357CA~2~IM~RA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~0672Y~1~IM~LA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0356536	09/04/2009	MN	15.0	15		F	08/28/2009	Large area of redness surrounding injection site approx 2 inches in diameter, warm to touch, mildly sore & raised, no other symptoms - occurred within a day of injection.									Y	08/25/2009				PVT	UNK						1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3200AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB312AA~1~UN~RA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2873AA~1~UN~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~0733Y~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0356537	09/04/2009	KY	1.0	0	1	F	08/31/2009	Hoarseness, diarrhea - 24 hours after vx given.									Y	08/21/2009	08/22/2009	1		PVT	PVT	POLY VI SOL vitamins					1						1	Diarrhoea; Dysphonia	FLU3~SANOFI PASTEUR~UF3171DA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356550	09/04/2009	WI	11.0	11		M	09/04/2009	Patient received Intranasal Influenza Vaccine at approximately 3:15 PM on 9/3/2009. By approximately 6:00 PM on 9/3/2009. patient complained of his upper lip feeling 'funny.' His upper lip was noticably swollen. Patient was given a frozen popsicle to help reduce the swelling. By approximately 7:00 PM, I observed patient's bottom lip had begun to swell. At that time, patient was given diphenhydramine 25mg by mouth. He continued to complain of discomfort to his lips. Patient denied shortness of breath, sore throat, itchiness & tongue symptoms. His nose and nares were mildly swollen. Patient went to sleep around 9:00 PM and slept uneventfully. I checked patient at 5:00AM today (9/4/2009), and his upper and bottom lips were still quite swollen. Patient was given another 25mg dose of diphendydramine. I will notify his provider when the clinic opens this morning.									U	09/03/2009	09/03/2009	0	None	UNK	UNK	None	None	None			1						1	Lip pain; Lip swelling; Nasal oedema	DTAP~UNKNOWN MANUFACTURER~~2~IM~LA~DTAP (NO BRAND NAME)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356558	09/04/2009	TN	66.0	66		M	09/04/2009	Patient called on 09/04/09 to report moderate swelling redness with red streak from injection site to elbow RT arm. Advised patient to apply cool cloths to site and if swelling worsens to see PCP.									U	08/31/2009	09/01/2009	1		PUB	PUB		None	none			1						1	Injection site erythema; Injection site streaking; Injection site swelling	FLU3~SANOFI PASTEUR~U3203AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1161X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C3032AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0356564	09/04/2009	CA	0.5	0	.0	F	09/04/2009	12 hours after the injection my son had a tempature of 102 and we could not get it down. He was very miserable and fussy and would not eat or sleep. We are on day 3 and the dr does not seem to be concerned.									N	03/12/2009	03/13/2009	1		UNK	PVT		None				1						1	Body temperature increased; Diet refusal; Insomnia; Irritability	DTAPHEPBIP~UNKNOWN MANUFACTURER~V06.8~UNK~IM~LL~DTAP + HEPB + IPV (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~V04.814~1~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~V03.82~UNK~IM~RL~PNEUMO (NO BRAND NAME)~1|RVX~UNKNOWN MANUFACTURER~V04.89~UNK~IM~LL~ROTAVIRUS (NO BRAND NAME)~1	USA		Influenza
0356569	09/04/2009	MD	19.0	19		M	09/04/2009	Rash/Itching following FLUMIST (Flumist not an option as a vaccination in #13).				Y					Y	09/03/2009	09/03/2009	0	N/A	MIL	MIL	Keflex	Dermatitis	None			1						1	Pruritus; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0356573	09/04/2009	KY	12.0	12		F	09/04/2009	Gardasil #1, Hep A #1, Menactra and flu given 10/5/07.  Patient seen 5/12/08 and reported vomiting several times a week since thanksgiving (about 6-7 weeks after vaccine), limb pain, parasthesia's, headaches and fatigue.  Patient still nearly 2 years later with vomiting several times a week, leg pain and tremors in her right hand/arm bad enough to interfere with school work and writing.  She has had extensive GI and neuro evaluation with no diagnosis and no satisfactory treatment of symptoms.  We do not know if this is related to gardasil but have begun to question it.  She had a second gardasil 7/21/08.  Of note, this patient has a sister with a severe mitochondrial disorder affecting her gut function, seizures, deteriorating mental function.  9/14/09 MR received from pcp which include multi-specialty consults  dated from 10/2007 to 9/2009. In for WCC 10/5/07 with dx: Well.  4 vax given. Multiple visits after for pharyngitis, URI, tinea corporis, vomiting x 6 months with 8 lb weight loss, H/A, blurry vision, lower limb pain, decreased sleep, strep throat. Dx:  Migraine/vomiting weight loss.  Referred for labs and consults. By 9/3/09 reporting continued vomiting, tremors, muscle pain. GI consult with no specific dx made.  6/16/09 reports worsening of sx.  PE (+) for fine tremor of tongue and hands.  Neuro consult  6/29/09 with impression:  Migraine complex. Returned for w/u for possible seizures due to episodes or tremors and jerking of the R side.				Y					N	10/05/2007	11/25/2007	51	carnitine level low, scope nl, fasting blood sugar, b12, folate, heavy metal screen, sleep study, ekg all nl as far as I know.  EEG abnl--getting further studies. Labs and diagnostics:  MRI head (-).  Upper GI with small bowel WNL. EGD WNL. Abd/pelvic  US WNL.T4 low at 5.5. EEG abnormal.	UNK	UNK	micronor at time of vaccination.  Now on lo ovral, ponstel, zofran, carafate, lactaid, prilosec, amitryptyline	well	menorrhagia. PMH:  Menorrhagia. ankle pain.	none~ ()~~0.00~Patient|none~ ()~~0.00~Sibling		1						1	Activities of daily living impaired; Blood folate normal; Blood glucose normal; Blood heavy metal normal; Carnitine decreased; Electrocardiogram normal; Electroencephalogram abnormal; Fatigue; Headache; Pain in extremity; Paraesthesia; Sleep study normal; Tremor; Vitamin B12 normal; Vomiting	FLU3~SANOFI PASTEUR~02442AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0797V~1~IM~RA~HEP A (VAQTA)~1|HPV4~MERCK & CO. INC.~1063V~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~12228AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0356574	09/04/2009	TX	27.0	27		F	09/04/2009	SITE RXN 2.5-3 INCH DIAMETER, REDNESS AT SITE, ITCHING SUBSIDED AFTER 9/3, STILL REDNESS AND HARD BUMP AT SITE									N	09/02/2009	09/03/2009	1		UNK	PVT	LOW-OGESTROL, PERCOCET					1						1	Injection site erythema; Injection site induration; Injection site nodule; Injection site pruritus; Injection site reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0356576	09/04/2009	TX	76.0	76		F	09/04/2009	Patient received Flulaval Vaccine IM on 9-3-09. Pt experienced soreness at injection and a knot developed almost immediately. 24 hours later, pt. returned to Pharmacy to see if reaction effected absorption of vaccine. Sweeling is localised and has not increased. Treatment recommended was Tylenol for discomfort and warm compress for swelling. Pt. has appt to see Dr for regular check up next week and will ask if Dr if case worsens or shows no improvement. (possible cellulitis)									U	09/03/2009	09/03/2009	0		UNK	PUB		HYPERTENSION				1						1	Immediate post-injection reaction; Injection site nodule; Injection site pain; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA259AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0356578	09/04/2009	IA	37.0	37		F	09/04/2009	Pneumonia vaccine received this morning has made me very sick. The pain at the injection site is severe and similar to the pain I had when receiving this vaccine several years ago. Over the course of the day, I developed flu-like symptoms, including body pain, a fever and a headache.										09/04/2009	09/04/2009	0		UNK	UNK		NOne	I am a type I diabetic (diagnosed 30 years ago).			1						1	Headache; Influenza like illness; Injection site pain; Malaise; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0356579	09/04/2009	IL	82.0	82		F	09/04/2009	Patient started to feel numbness in arm down to her hands approximately 2 hours after recieving vaccine in her left arm which lasted for few hours.  After numbness has gone, Patient still had severe pain in her left arm which inhibited her from daily functions like clothing, getting herself up from chair.  The pain lasted for about 4 full days.  Today is 5th day and patient feels better and able to move arm to drive a vehicle, but patient still complains of pain in left arm which is definitely better than past 4 days.									U	08/31/2009	08/31/2009	0	0	UNK	PUB						1						1	Activities of daily living impaired; Hypoaesthesia; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0356615	09/04/2009	TX	48.0	48		F	09/07/2009	She received vaccine on Friday 9-4-2009. Injection site became swollen and dark, came back to pharmacy to have other family member to get immunization, and show me 2cm size dark bruise (3 days later on 9-7-09). It became better but still sore.									U	09/04/2009	09/04/2009	0		OTH	PVT	No	No	No			1						1	Injection site haematoma; Injection site pain; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97843P2~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0356617	09/04/2009	TX	69.0	69		F	09/06/2009	Patient received vaccines (FLUVIRIN & PNEUMOVAX) on 9/3/09 at 130pm. FLUVIRIN in right arm, and PNEUMOVAX in left arm. I advised her that PNEUMOVAX could make her left arm sore. Patient states that by 7pm on 9/3/09 her arm began to ache & she had problems lifting her left arm. She says symptoms have persisted. I advised her to call her Dr. as soon as possible.									U	09/03/2009	09/03/2009	0		UNK	OTH		None				1						1	Injected limb mobility decreased; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2A~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0868X~2~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0356618	09/04/2009	CT	57.0	57		F	09/05/2009	Shortly after FLUVIRIN administered patient complained of dizziness, shaking & pallor. BP taken at 87/59. Patient informed us at this point of previous vasovagal episodes not related to shots. 911 called, when emergency team arrived BP was even lower. Glucose was also low. Went to ER at recommendation of paramedics.				Y					U	09/04/2009	09/04/2009	0		OTH	PVT	Unknown	None	Controlled seizure disorder			1						1	Blood glucose decreased; Blood pressure decreased; Dizziness; Pallor; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0356619	09/04/2009	TX	65.0	65		F	09/06/2009	5 minutes after receiving PNEUMOVAX and FLUVIRIN, pt. complained of hotness all over & tingling on her tongue. EMS were dispatched. BP & pulse  were WNL for pt's medical history. Pt. refused ER visit & asked to go home 45 minutes after vaccine.									Y	09/01/2009	09/01/2009	0		OTH	PUB	Unknown	None	Hypertension; Hypercholesterolemia			1						1	Blood pressure normal; Feeling hot; Heart rate normal; Paraesthesia oral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97843P2~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1296X~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0356620	09/04/2009	CA	32.0	32		F	09/05/2009	Reports of soreness in the whole arm but mostly from elbow to the wrist, slightly itchy, looks like sunburn but not hives. Advised to use cold compress, TYLENOL & BENADRYL.									Y	09/04/2009	09/04/2009	0		OTH	PVT		None	Percocet allergy			1						1	Erythema; Pain in extremity; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97864P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0356622	09/04/2009	CA	53.0	53		M	09/04/2009	Right arm had vaccine injected was swollen & painful. Pt. had fever and some heavy breathing. Pt took some TYLENOL and BENADRYL and got better the next day.									Y	09/02/2009	09/02/2009	0		OTH	PVT		None	None			1						1	Hyperventilation; Injection site pain; Injection site swelling; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0627Y~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0356623	09/04/2009	CA	72.0	72		M	09/05/2009	9/2 at noon receive influenza, pneumococcal vaccine. 9/3 nauseated, achy. Thursday pm - redness (L) upper arm. 9/5 seen here large cellulitis.				Y					U	09/02/2009	09/03/2009	1		PVT	UNK		No	HTN; Back & neck injuries			1						1	Cellulitis; Injection site erythema; Nausea; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0356624	09/04/2009	MD	64.0	64		F	09/05/2009	2-3 flat red rash now itching at injection site.									Y	09/01/2009	09/03/2009	2	site reaction	OTH	PUB		None				1						1	Injection site erythema; Injection site pruritus; Injection site rash; Injection site reaction	FLU3~SANOFI PASTEUR~U3184AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356626	09/04/2009	TX	67.0	67		F	09/05/2009	Swelling - warm. Aches - all over especially neck, jaw.				Y					U	09/04/2009	09/04/2009	0		OTH	PUB	SINGULAIR; PIROXICOM; High blood pressured med	None				1						1	Neck pain; Pain; Pain in jaw; Skin warm; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97843P2~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~9722106~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0356628	09/04/2009	CO	36.0	36		M	09/04/2009	Patient appeared okay after flu vaccine was administered. About 10 minutes after vaccine administered, he complained of pain in the arm, abdomen and shortness of breath. EMS was called. They arrived shortly after.				Y					U	09/04/2009	09/04/2009	0		OTH	UNK	Oxycodone/APAP 5/325mg		NKA			1						1	Abdominal pain; Dyspnoea; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0356629	09/04/2009	NC	55.0	55		F	09/04/2009	Administered vaccine at 1:15pm on 9-3-09. Symptoms were reported at 6:00pm. Red face going down neck splotchy rash, flushed feeling. Skin hot to touch. No swelling in airways.									U	09/03/2009	09/03/2009	0		OTH	PVT		None				1						1	Erythema; Flushing; Rash macular; Skin warm	FLU3~SANOFI PASTEUR~U3191AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356632	09/04/2009	CT	17.0	17		M	09/03/2009	Red face & eyes after vaccine - sneezed for hrs. eye swollen. No wheezing.									U	08/31/2009	09/01/2009	1		PVT	PVT	None	None	None			1						1	Erythema; Eye swelling; Ocular hyperaemia; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~500675P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356581	09/05/2009	TX	2.0	2	.8	M	09/05/2009	none									Y	09/02/2009	09/02/2009	0		PVT	PVT	none	none	none			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~u3193~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356583	09/05/2009	CO	60.0	60		M	09/05/2009	Swelling from ankles to knees, worse at 12 hours post injection, now improved but still an issue for patient.									U	09/02/2009	09/03/2009	1	none	UNK	PVT	Unknown	Unknown	Unknown	unknown~ ()~NULL~~In Patient		1						1	Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~96030 5P~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0356585	09/05/2009	CA	1.23	1	.2	M	09/05/2009	Vaccines Administered 08/26/09. He started having high fever on 09/01/09. He began to become extremely fussy and some nausea. Fever continued to increase from 100 -101 F to 102 - 103 F. He was taken to doctor on 09/04/2009. He was diagnosed as having a reaction to MMR vaccine. Was told to monitor him. Was told to bring him back if fever continued beyond 09/07/2009.				Y					U	08/26/2009	09/01/2009	6		UNK	UNK		None	food allergies:Milk, Wheat, Soy, Nuts. Allergic reaction to Amoxicillin			1						1	Irritability; Nausea; Pyrexia; Vaccination complication	FLUX~UNKNOWN MANUFACTURER~unknown~2~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~unknown~2~UN~UN~HEP B (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~unknown~1~UN~UN~HEP A (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~unknown~1~UN~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~unknown~1~UN~UN~VARICELLA (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0356625	09/05/2009	KY	51.0	51		F	09/05/2009	Redness at injection site - swelling from injection site, down arm almost to elbow, arm is tender & hot to the touch. Patient advised to seek medical care.									U	09/03/2009	09/05/2009	2		OTH	OTH	NEXIUM; PERCOCET; XANAX; OXYCONTIN; COMBIVENT	None				1						1	Injection site erythema; Injection site swelling; Skin warm; Tenderness	FLU3~SANOFI PASTEUR~U3171AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356589	09/06/2009	MD	66.0	66		F	09/06/2009	local site or injection became inflamed and swolen within an area of 2.5 inches in circumfernce. The area was noticably re and enlarged. The injection was given about 4 PM on wednesday and the redness, swelling and discomfort were noticed about 2 hours later. The discomfort redness and swelling have decreased though are still noticable on sat. evening about 11 PM. Cold compresses were used. Slightly elevated body temperature was experience on We. and thursday.									Y	09/03/2009	09/03/2009	0		UNK	PVT	synthroid,cymbalta,provigil, multivitamins,calcium, d, Preservision	None	None			1						1	Body temperature increased; Injection site discomfort; Injection site erythema; Injection site inflammation; Injection site swelling	FLU3~SANOFI PASTEUR~mdv~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356593	09/06/2009	TX	68.0	68		F	09/06/2009	WITHIN 24 HOURS PATIENT DEVELOPED SEVERE EMESIS AND DIARRHEA WITH A HIGH GRADE FEVER OVER 105F. PATIENT WENT TO DOCTOR OFFICE 9-6-2009 AND PRESENTED WITH A FEVER OF 104F AND WAS GIVEN RX FOR LOMOTIL TO HELP WITH THE DIARRHEA SYMPTOMS				Y					U	09/01/2009	09/02/2009	1		PUB	PVT		NONE				1						1	Diarrhoea; Pyrexia; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA259AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0356594	09/06/2009	MI	61.0	61		M	09/06/2009	Difficult Breathing.  Rapid Heart Rate. 9/9/09 ER records received DOS 9/4/09. Assessment: Atrial flutter with rapid ventricular rate and cardioversion. Developed angina, left-sided jaw pain. Heart rate 150-160. Tachycardia. Cardioversion. Discharged to home.			Y	Y					Y	09/01/2009	09/03/2009	2	Atrial Flutter, increase in enzymes. 9/9/09 ER records received DOS 9/4/09. LABS and DIAGNOSTICS: CK-MB 12.8 ng/mL (H). CHEM - Chloride 99.0 mmol/L (L) CBC - Neu (ABS) 6.9 K/uL (H). Chest X-ray - Abnormal, heart enlarged.	UNK	UNK		none	congestive heart and afib. 9/9/09 ER records received DOS 9/4/09.  Recurrent atrial flutter, coronary artery bypass graft, stent placement, congestive heart failure. Angina. Type 2 diabetes, hyperlipidemia, non-Hodgkins lymphoma, pacemaker with internal defibrillator. Appendectomy. Sulfa allergy.			1						1	Atrial flutter; Dyspnoea; Enzyme abnormality; Heart rate increased	FLU3~CSL LIMITED~U3197AB~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Life Threatening	Influenza
0356595	09/06/2009	OH	66.0	66		F	09/06/2009	Received pneumovax and influenza at 11:40am on Sept 5. By 9pm had sore arm. Next day, awoke with redness spreading over entire deltoid area of 5X5 inches. Also had body aches and red lines running from the injection site. Temperature of 100. Feel awful. Taking Benadryl and going to bed.									U	09/05/2009	09/05/2009	0	Received flu vaccine and pneumovax in left arm at 11:40am on Sept.5. By night had arm pain and by morning had large 4in X4inch area of erythema ? cellulitis  with radiating red lines reaching around the site. Also had multiple body aches and fever of 100. Used compresses on arm to speed circulation. Also took Benadryl before bed the next night. Pain in arm radiates down following the nerve to wrist.	UNK	UNK	Atenolol/Diovan and C	NONE	NONE			1						1	Injection site erythema; Injection site pain; Injection site streaking; Malaise; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IJ~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0356621	09/06/2009	GA	68.0	68		F	09/06/2009	Pt came to pharmacy states she woke up today with rash on the body (trunk). Consult pt to take 2 BENADRYL and contact or seek medical attention if worsen. Pt called back 4 hours later. State rash & itch worsen and body in pain. I ask pt to go to emergency room for medical attention.				Y					U	09/04/2009	09/06/2009	2		OTH	OTH		No	Codeine			1						1	Pain; Pruritus; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97844P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0356616	09/07/2009	KS	75.0	75		F	09/07/2009	Patient called in. Itchy rash to upper back & shoulders. States no SUA or any other sx. Rash does not go past mid back or above shoulders or on arms. Using BENADRYL creams & helping.										09/06/2009	09/07/2009	1	Requested patient to return to clinic but she refused. She plans to see her PCP.	OTH	PVT	AMARYL; LANTUS; Levothyroxine; Hydrocodone	None	Diabetes; Hypothyroidism; Chronic pain			1						1	Rash pruritic	FLU3~SANOFI PASTEUR~U3191AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356661	09/08/2009	VA	56.0	56		F	09/03/2009	Started hurting and then swelling.  Pain is deep in arm and hurts from shoulder to elbow.										09/01/2009	09/02/2009	1		OTH	OTH		None	Sulfa Drugs			1						1	Pain in extremity; Swelling	FLU3~SANOFI PASTEUR~U3199AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356672	09/08/2009	NY	31.0	31		F	09/08/2009	Chest tightness - monitored a little lightheaded.									Y	09/08/2009	09/08/2009	0		OTH	OTH						1						1	Chest discomfort; Dizziness	FLU3~SANOFI PASTEUR~U3178BA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356677	09/08/2009	MN	3.0	3		M	09/08/2009	Flu mist administered 8/27/2009, On 9/7, developed calf pain, refusal to walk, and then rash.  Seen in clinic with typical rash of Henoch Schonlein Purpura, mildly tender calves without joint findings or abdominal pain. (9/8/09 clinic).				Y					U	08/27/2009	09/07/2009	11	UA pending	PVT	UNK		None	None			1						1	Gait disturbance; Henoch-Schonlein purpura; Pain in extremity; Rash; Tenderness; Urine analysis	FLUN3~MEDIMMUNE VACCINES, INC.~500675P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0356681	09/08/2009	MA	67.0	67		F	09/01/2009	Patient complained of dizziness, lightheadedness, blurred vision and numbness of face 20 minutes following immunization.  Patient sat down with head between legs with a cold compress for face & neck.  Patient denied any trouble breathing.  BP 150/80 pulse 68.  Then 30 min later 128/76 pulse 60.									Y	09/01/2009	09/01/2009	0	BP 150/80; pulse 68.  After 30 min 128/76; pulse 60.	OTH	PVT	Unknown	Unknown/ none mentioned	Unknown			1						1	Dizziness; Heart rate normal; Hypoaesthesia facial; Vision blurred	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0356697	09/08/2009	AR	1.25	1	.3	M	09/08/2009	NO ADVERSE EVENTS NOTED AT TIME OF COMPLETING THIS FORM. Patient was given 0.5ml of Fluzone on 26-Aug-2009 and then again on 02-Sep-2009.									Y	09/02/2009			PATIENT WAS GIVEN 0.5ML OF FLUZONE ON 26-AUG-2009 AND THEN AGAIN GIVEN 0.5ML OF FLUZONE ON 02-SEP-2009	PVT	PVT		ECZEMA	N/A			1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U3176AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356702	09/08/2009	AR	52.0	52		F	09/08/2009	headache, difficulty breathing, chest and throat tightness,				Y					Y	09/02/2009	09/02/2009	0	N/A	PUB	UNK	Hormones, vitorin	no	N/A			1						1	Chest discomfort; Dyspnoea; Headache; Throat tightness	FLU3~SANOFI PASTEUR~U3259GA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0356703	09/08/2009	NY		34		M	09/08/2009	Pt woke up 3days post flu mist administration with Pells Palsy. Left side of face was affected. Received treatment with steroid through civilian provider				Y					Y	10/18/2008	10/21/2008	3		MIL	MIL	Denies	Denies	Denies			1						1	Facial palsy	FLUN3~MEDIMMUNE VACCINES, INC.~500552P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0356706	09/08/2009	CA	51.0	52		M	09/08/2009	patient reported low grade fever, aching all over, just like I was getting flu about 24 h after admin lasting for 12-16h relieved with ibuprofen									Y	09/06/2009	09/07/2009	1	none	PVT	PVT	none	none	none			1						1	Influenza like illness; Pain; Pyrexia	FLU3~SANOFI PASTEUR~u3259EA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356711	09/08/2009	WA	65.0	65		F	09/08/2009	Pt presented to facility after recieving the Pneumovax Vaccine at the medical clinic, prescribed by Dr. with pain, redness, swelling at injection site.  Dr. prescribed Clarinex 5mg, ice/heat and ibuprofen for pain.									U	09/04/2009	09/06/2009	2	995.2	UNK	UNK	Altrace, Clonidine, toprolol, potassium	none				1						1	Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~00000~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~00000~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0356714	09/08/2009	OH	31.0	31		F	09/08/2009	Flu shot administered about 5:30 PM.  Phone call at 7 PM stating edema in left arm from elbow to fingers.  Some mild pain in fingers (had to remove rings) and wrist.  Reaction started around 6:15 PM per patient.  Had flu shot 1 previous time last year 2008.  Instructed patient to call primary care doctor if conditioned worsen.  Tonight or go to ER.  Instructed patient to call MD in morning even if feeling better.  Pt took 2 BENADRYL & 4 MOTIN at 8:15 PM swelling decreased.									U	09/08/2009	09/08/2009	0		OTH	OTH		None	None			1						1	Arthralgia; Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~9783P2~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0356715	09/08/2009	CO	50.0	50		F	09/08/2009	Patient described pain in arm with striations. Patient was diagnosed with Pneumonia on 9/07/09.				Y					U	09/05/2009	09/08/2009	3	Waiting for patient call-back with more information.	OTH	PVT			Sulfa; Codeine; Quinolones; Nifedipine			1						1	Pain in extremity; Pneumonia; Skin striae	FLU3~SANOFI PASTEUR~U3190AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1296X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0356717	09/08/2009	IA	37.0	37		F	09/04/2009	Had asthma-like attack, body aches, chills, violent coughing, says lungs felt like they were on fire.				Y					Y	09/03/2009	09/03/2009	0		PVT	PVT		None	Pregnant			1						1	Asthma; Burning sensation; Chills; Cough; Pain	FLU3~SANOFI PASTEUR~U3187AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0356718	09/08/2009	IL	52.0	52		F	09/08/2009	Pt experienced heart racing followed by jittery/nervous felling. Pt took alprazolam, which helped calmed her  and heart. Symptoms returned next morning, called pharmacy at 1pm. Instructed to call MD, who instructed pt to take another, alprazolam; which helped to relieve symptoms. Pt reports getting several in past with no problems.									Y	09/07/2009	09/07/2009	0		OTH	OTH			allergies: Varenicline; Tramadol; VICODIN; conditions: Osteoporosis; lateral epicondylitis (elbow); depression with anxiety; hypothyroidism; nicotine use			1						1	Feeling jittery; Nervousness; Palpitations	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0356720	09/08/2009	NC	45.0	45		F	09/08/2009	Myalgia, muscle joint pain, fatigue, nausea.  States reaction 4-5 days post vaccine x 5 years.  Onset within hours after flu vaccine.				Y					Y	08/24/2009	08/25/2009	1	CBC; C-reaction protein;	PVT	OTH		None	None	Save Symptoms~Influenza (Seasonal) (no brand name)~UN~41.00~Patient		1						1	Arthralgia; C-reactive protein; Fatigue; Full blood count; Myalgia; Nausea	FLU3~SANOFI PASTEUR~U3196AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0356722	09/08/2009	TX	38.0	38		F	09/07/2009	Pt only reported sharp pain in left arm 30 min after injection. She took OTC pain tabs and used an ice pack. Pain started to go away 15 to 20 min. later.									Y	09/07/2009	09/07/2009	0		UNK	OTH						1						1	Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0356724	09/08/2009	SC	75.0	75		F	09/08/2009	15 minutes after patient received injection she stated that the area where she was injected itched a little bit.  We had her wait another 5 minutes or so and only the area at the injection site itched still.  I recommended some ice and ZYRTEC and a phone call to her Dr if no improvement.									Y	09/08/2009	09/08/2009	0		OTH	PUB						1						1	Injection site pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0356726	09/08/2009	KY	32.0	32		F	09/04/2009	Hoarseness, wheezing, weakness, difficulty breathing. Sent employee to medical center for evaluation. TX with steroids.				Y					Y	09/04/2009	09/04/2009	0		OTH	OTH	ZOLOFT 100mg qd		Asthma stable for yrs per pt.			1						1	Asthenia; Dysphonia; Dyspnoea; Wheezing	FLU3~SANOFI PASTEUR~U3191AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0356727	09/08/2009	AK	60.0			U		Pt developed hives 1 day later on inner elbows of both arms.  They are currently fading.  Pt did not seek medical tx & took no medications.									Y					OTH	PVT		None	None			1						1	Urticaria	FLU3~SANOFI PASTEUR~U3190AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356731	09/08/2009	MA	1.4	1	.4	M	09/03/2009	At 16 mo visit on 1/23/09, child had single words and could point to indicate wants. No animal names or noises. Rec. increased reading to child. MMR/Varicella/PREVENAR/Flu given. After this visit, the child's language regressed and he began hand flapping and would not follow directions.   9/8/09 VAERS report received with MR attached.  WCC 1/23/09 with normal exam except abnormal weight gain.  Saying 3 words at this time.  Vax given.  Returned 3/20/09 with parental concerns for speech regression over past few months as well as flapping his hands when excited.  Does maintain eye contact however clear regression of speech noted by MD. Sent for genetic, neuro and developmental testing. Evals (+) for developmental delays, macrocephaly, toe walking. sx c/w autism.								Y	N	01/23/2009	02/23/2009	31	See attached pre & post charts, EI evaluation, Genetics evaluation - see attached Labs and Diagnostics:  Chromosomal microarray analysis (+) for variant of possible significance.  Fragile X (-).  Normal karyotype.  MRI brain	PVT	PVT	None	None	Mild expressive speech delay. No receptive delay. PMH: mild expressive speech delay			1						1	Abnormal behaviour; Speech disorder developmental	FLUX~SANOFI PASTEUR~UT2782DA~1~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~1083X~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~A05882~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1533X~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Disabling	Influenza
0356712	09/09/2009	CA	74.0	74		M	09/09/2009	Patient reported that he had not receive Pneumo vaccine in the past.  Patient received Flu vaccine (left arm) and Pneumo vaccine (right arm) on Friday 9/4/09. On Monday 9/7/09 pt reported fever (100.6) for 2 days, chills and malaise for 2-3 days, tenderness and redness on right arm til present. Currently pt is feeling normal except for the slight tenderness on the right arm. He now recalled that he did received a pneumo vaccine 2 years ago and experienced chills after the vaccination.  Patient stated that he will see MD on Thursday.									Y	09/04/2009	09/04/2009	0		UNK	PVT	Lisinopril, Toprol XL, Klonopin, Lovastatin, Levothyroxine, Triamterene/HCT, Aleve	none		shivering, chills~Pneumo (no brand name)~NULL~72.00~In Patient		1						1	Chills; Erythema; Malaise; Pyrexia; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0627Y~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0356763	09/09/2009	CA	46.0	46		F	09/03/2009	11/27/07 had scratchy throat, coughing, the symptoms went to thrush, fever, high blood pressure, loss/slurred speech, loss of appetite, fatigue. I saw doctor on 12/5/07 gave me IV for dehydration sent me home. 12/6/07 Woke up seeing double vision, saw Ophthalmologist; went to ER - admitted for 6 days - diagnosed with Guillain Barre syndrome at hospital.  11/9/09 DC summary, hospital records recieved service dates 12/6/2007 to 12/12/2007. Assessment: 1. Miller Fisher varient of Guillain-Barre syndrome. 2. Hypertension. 3. Inability to close (L) eye or tear properly, dysarthria with nasal voice. Peripheral facial droop.   Sore throat past 9 days, oral thrush. Fatigue, slurred speech, unsteadiness walking, shuffling gate, and uncoordination. Patient admitted with symptoms of diplopia, palatable dysfunction, ataxia, and areflexia, along with non-reactive pupils. Reflexes absent/decreased. IVIG X 5 days. Tachycardia. Ambulates with walker.			Y	Y	Y	6			U	10/17/2007	11/27/2007	41	12/6/07 - ER - Spinal Tap and CT scan - 12/7/07 - MRI - All blood work. 11/9/09 DC summary, hospital records recieved service dates 12/6/2007 to 12/12/2007. LABS and DIAGNOSTICS: EKG - Abnormal, sinus tachycardia, nonspecific inferior T abnormalities. CBC - MONO 13% (H) Anisocytosis 1+ Macrocytosis 1+. CHEM - Sodium 134 mEq/L (L). Folate 18.3 ng/mL (H). Rickettsia Typhus Group IGG (+) titer 1:64 (H). PT 11.8 sec (H) APTT 32.8 sec (H). CSF - Albumin 12.4 mg/dL (L), protein 36(N), glucose52(N). Urine - Protein 10 mg/dL (H), Leukocyte Esterase trace, Squamous cells 47 /LPF (H), Epithelial cells 27 /LPF (H).	PUB	OTH	Lisinopril	None	High blood pressure. 11/9/09 DC summary, hospital records recieved service dates 12/6/2007 to 12/12/2007. Hypertension.			1						1	Aphasia; Blood test; Candidiasis; Computerised tomogram; Condition aggravated; Cough; Decreased appetite; Dehydration; Diplopia; Dysarthria; Fatigue; Guillain-Barre syndrome; Hypertension; Lumbar puncture; Nuclear magnetic resonance imaging; Pyrexia; Throat irritation	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~78991~5~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0356769	09/09/2009	MA				F	08/28/2009	RN here this AM for flu vaccination.  Approximately 2 hrs later (12 noon), pt developed persistent coughing, no wheezy, dyspnea, truritis, mucose swelling.  Irritated throat but no tightness complaints.				Y					U	08/28/2009	08/28/2009	0	Referred to Emergency Dept. for further evaluation and treatment.	PVT	OTH	None	None	No			1						1	Cough; Swelling; Throat irritation	FLUX~SANOFI PASTEUR~U3167EA~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0356771	09/09/2009	OH	5.0	5		F	09/02/2009	Mom brought in 2 children for vaccines - baskets/containers were side by side - 5 yr old was kicking & fighting - grabbed the wrong basket & administered Flu & BOOSTRIX which were intended for 12 yr old child, who was also receiving vaccines.									Y	09/01/2009	09/01/2009	0		PVT	PVT						1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U3186AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B041CA~1~IM~RL~TDAP (BOOSTRIX)~1	USA		Influenza
0356774	09/09/2009	VA	11.0	11		F	09/03/2004	Generalized urticaria 6 days after receiving vaccines Tx - BENADRYL 25-50mg every 6 hours prn.				Y					U	08/26/2009	09/01/2009	6	None	PVT	PVT	None	None	Eczema			1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500675P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~MERCK & CO. INC.~0604Y~1~~LA~HEP A (VAQTA)~1|MNQ~SANOFI PASTEUR~U2926AA~1~~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C3058AA~6~~RA~TDAP (ADACEL)~1|VARCEL~MERCK & CO. INC.~0929Y~2~~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0356784	09/09/2009	WA	67.0	67		F	09/04/2009	Red, hot. Tues evening using ice packs. Worse on Wed swelling. Same on Thurs. Redness worse and puffing on Fri.									N	09/01/2009			None	OTH	PUB	PRILOSEC, FCL, HCTZ, Methotrexate, Bupropion, LIPITOR, Betamethasone Dipropionate, Hydrocodone/APAP, OTCs	No	No			1						1	Erythema; Skin warm; Swelling	FLU3~SANOFI PASTEUR~43190AA~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1296X~2~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0356789	09/09/2009	OH	1.4	1	.4	F	09/01/2009	8-31-09 @ 7:30 pm - lower right thigh red - dime size, upper right thigh slightly red, low grade fever, pain 9-1-09 PREVENAR @ 7 am - red, nickel size, 12:20 pm, red, raised - warm > lower (R) thigh upper (R) thigh remains red, low grade fever, pain 4:15 - in office : upper (R) thigh 3/4 in x 1 in - red, lower (R) thigh 2in x 1 in warm, raised, red - saw MD gave TYLENOL every 4 hrs since injection 99.2 degrees.				Y						08/31/2009	08/31/2009	0		PVT	PVT	None	None	Latex Allergy			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pyrexia	DTAP~SANOFI PASTEUR~C3157AA~4~IM~RL~DTAP (DAPTACEL)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~UT3173GA~3~IM~LL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PNC~PFIZER\WYETH~D81705~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0356795	09/09/2009	IN	0.57	0	.6	F	09/03/2009	Localized allergic reaction.				Y					Y	09/03/2009	09/03/2009	0		PVT	PVT	None	None	None	~Hib (no brand name)~2~0.30~Patient		1						1	Hypersensitivity; Local reaction	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B208BA~4~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U3191AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF596AA~4~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~081705~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0356796	09/09/2009	NY	66.0	66		F	09/03/2009	Difficulty breathing, rash development, dizziness.				Y					U	09/02/2009	09/03/2009	1		PUB	PUB						1						1	Dizziness; Dyspnoea; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0356798	09/09/2009	IL	18.0	18		M		See attached.									Y	07/27/2009	07/27/2009	0		MIL	MIL	BICILLIN	None				1						1	Pruritus; Rash; Urticaria	FLU3~CSL LIMITED~AFLLA192AA~1~UN~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB245AB~1~UN~LA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2992AA~1~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B046AA~1~UN~RA~TDAP (BOOSTRIX)~1	USA		Influenza
0356800	09/09/2009	IN	58.0	58		F	09/03/2009	Within 5 mins of receiving flu shot, patient experienced nausea and dizziness.  Symptoms lasted a few minutes & Patient was able to walk out.									Y	09/02/2009	09/02/2009	0	None	OTH	UNK	None/Unknown	None				1						1	Dizziness; Nausea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~07841P1~1~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0356802	09/09/2009	TX	66.0	66		F	09/01/2009	8-29-09 (Mild Fever). 8-30-09 & 8-31-09-(Chills & Fever of 102.5 on & off). 9-01-09-Redness on arm covered all of arm above elbow-9-1-09 saw Dr & was given a pers. For Amox-Clav.									N	08/29/2009	08/29/2009	0		UNK	UNK	Levothyroxine, Metroprolol	None	No			1						1	Erythema; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0356804	09/09/2009	CT	14.0	14		F	09/04/2009	Onset of chronic headaches 21/2 month following HPV #2 Diagnostic w/u (-) .11/30/2009 PCP records 2-9/2009, ENT consult 7/2009 and Neuro consult records 4/2009. Dx tension headaches  Patient with hx of headaches, dizziness, vision changes with headaches. Neuro consult neg, ENT consult dx'd as tension headaches. Tx PT				Y					N	11/13/2008	02/24/2009	103	Labs: CBC, Lyme titer, ASO, Anti-Dnase B, LFT's, electrolytes all neg Dx studies: MRI Brain neg	PVT	PVT		None	PMH: None Allergies: NKDA			1						1	Headache	FLU3~SANOFI PASTEUR~U2898EA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB289CB~2~IM~UN~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~~UNK~UN~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0356815	09/09/2009	LA				U	09/09/2009	REACTION NOTED POST VACCINATION HANDS RED AND ITCHING									Y	09/02/2009	09/02/2009	0		PVT	UNK						1						1	Erythema; Pruritus	FLU3~SANOFI PASTEUR~U3191AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356816	09/09/2009	OH	76.0	76		F	09/08/2009	After receiving vaccine, pt states her entire upper arm swelled and she was not able to move arm all weekend. The under arm region also broke out in welts. She iced arm and took pain reliever and arm is just now (9/8) starting to go back to normal. However, still sore. No past rxn. per pt.									Y	09/04/2009				OTH	UNK	Acyclovir; HYZARR; TRAVATAN Z per profile	Fever; Swelling; redness; welts.	Unknown			1						1	Mobility decreased; No reaction on previous exposure to drug; Oedema peripheral; Pain in extremity; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~987841P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0356818	09/09/2009	NY	47.0	47		F	09/09/2009	Employee reported progressively worsening throat tightness after receiving flu vaccine.  Vaccine received at approximately 12:30pm on 9/8/09.  Sought treatment in ED at approx. 19:00 on 9/8/09.  C/o sx beginning approx 3.5hrs earlier, associated with burning eyes.  At time of ED tx sx assoc with difficulty breathing.  Tx with IV Solumedrol 125mg and IV Benadryl 25mg.  D/c home at 23:00 with report of improved sx.  D/c on Prednisone po and benadryl po prn				Y					Y	09/08/2009	09/08/2009	0	None	PUB	UNK	Lotrel 10mg-20mg capsule po daily, last does 9/7/09	Hypertension, Colon Cancer, s/p recent treatment	shellfish-Hives			1						1	Dyspnoea; Eye irritation; Throat tightness	FLU3~SANOFI PASTEUR~U3207AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0356826	09/09/2009	TX	40.0	40		F	09/09/2009	I received the seasonal flu shot around 4 p.m.  I woke up the next morning very itchy and developed hives all over my body.  I took Benadryl every 4 hours and used Caladryl.  It lasted for 48 hours.									Y	09/04/2009	09/05/2009	1		PUB	PVT	None	None	None			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U3199AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356830	09/09/2009	MO	61.0	61		M	09/09/2009	While there was no pain when shot was given, the next day there was a lot of pain in the arm at the injection location.									U	09/08/2009	09/09/2009	1		PUB	PVT						1						1	Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~?~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0356834	09/09/2009	TX	39.0	39		F	09/09/2009	PT COMPLAINED OF HER THROAT FEELING LIKE IT IS ON FIRE.										09/09/2009	09/09/2009	0		PUB	PVT			SUDAFED   ACTIFED  ASTHMA			1						1	Throat irritation	FLU3~SANOFI PASTEUR~U3191AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356837	09/09/2009	MN	61.0	61		M	09/08/2009	Breathing difficulty, body aches, chills apprx 36 hours.									U	09/01/2009	09/02/2009	1		MIL	UNK			Fibromyalgia;  Arthritis;  Depression;  Chronic Pain;  ETC.			1						1	Chills; Dyspnoea; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~UN~LA~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0356843	09/09/2009	IL	55.0	55		F	09/09/2009	Injection site red & hot inflammation grew in size over 6 days to 9cm x 6cm, and is still present. We took digital photos in case you want sent for study. Notes below: September 03, 2009 Thursday at abt 2:00pm was injected in right arm at doctor's office. BP 125/68 temp abt 97.8. That night about 9pm by runny nose, sneezing, hot injection site. Unsure if pre-loaded syringes or from vial. Spouse also had an injection within half-hour by same practioner and he had no reaction, no redness (unsure if same lot & will ask doctor on Tuesday). By evening time PM inj site was irregular shaped red raise lump at inj site.  Sept 04, 2009 Friday a quick needle-like inj site pain, soreness at site, chills in evening, raised redness oval shaped and lump was enlarged. We googled and figured this was typical two-day post inj reaction and so proceeded to travel out-of-state on Saturday for Labor Day holiday for 4 days.  Sept 05, 2009 Saturday redness and inj site lump expanded, still with runny nose and soreness at inj site; with occasional sharp needlike pain with some flu-like feeling but not bad. Some sneezing. At evening around 7:30PM reexamined site at undressing due to increased soreness and shoulder discomfort, and, a runny nose but not bad. Redness lump grew to about the size of a silver-dollar coin. We don't understand why getting larger instead of diminishing. Digital photos taken (nightgown) to document reaction red circle in case doctors or govt wants. Sept 06, 2009 looked at inj site area in AM morning abt 9AM and site was hot and a little larger. In evening at abt 9pm, re-examined now at 81-hrs, with increased shoulder soreness throughout day. Found inject site redness and swelling and red raised circle had expanded further and was now the size 9-CM x 6 CM; the site is now red warm with itchy sensation at site. Note now it also appears at the center of the large bright red circle is an irregular-shaped deep purplish-red color about the size of a quarter coin. Spouse took two more digital photos to document (in geometric blouse). Then edges of red circle were marked with a pen to track whether red circle expands or recedes tomorrow Monday. Went online to FDA.gov website and see Vaers info. So same night, Sunday 09/06/2009 took temp at 23:19 (11:19PM) Oral temp= 97.7F. Sept 07, 2009 injection site still raised 9CM x 6CM with red color present but less bright;  Sept 08, 2009 injection site still raised 9CM x 6CM with red color present but less bright;  Sept 09, 2009: sore throat, neck pain, injection site still raised 9CM x 6CM with red color present but less bright; inj site normal temp still raised 9CM x 6CM with red color present but less bright and not sore. Phoned Doctors office, and was given lot# and manuf. to report. 9 cmx 6m, light red color, does not hurt. Spouse has taken pictures.									N	09/03/2009	09/03/2009	0	NO TESTS PERFORMED	UNK	UNK	QVAR, XOPENEX, TIZANIDINE4MG,	NONE. Seen for flu shot, for a prn diuretic rx in case of edema occurence.	Note in abt 2002 had a pneumonia vaccine with an injection site 'satellite'reaction elsewhere and was told just unusual but not to worry. HAS ALLERGIES TO SULPHA & RED DYES. CONDITIONS: TBI, OCCASIONAL B/L LOWER EDEMA. ORTHO/NEUROPATHOIES s/p x 11yrs,NECK,SHOULDER, SPINE, LOWER.			1						1	Chills; Influenza like illness; Injection site erythema; Injection site inflammation; Injection site papule; Injection site pruritus; Injection site swelling; Injection site warmth; Musculoskeletal discomfort; Neck pain; Oropharyngeal pain; Rhinorrhoea; Sneezing	FLU3~CSL LIMITED~01449211A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0356847	09/09/2009	WA	60.0	60		F	09/08/2009	Jaw -> eye numbness *Sx's gone @ 2pm L arm numbness/tingling in fingertips tongue- numbness.  Going away after 20 min of report.									Y	09/08/2009	09/08/2009	0		OTH	UNK						1						1	Hypoaesthesia; Hypoaesthesia facial; Paraesthesia; Paraesthesia oral	FLU3~SANOFI PASTEUR~U3190AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356854	09/09/2009	FL	31.0	31		M	09/09/2009	Sweating, Lethargic after 5 minutes following the administration of flu shot. Paramedics arrived 15 minutes later. Checked the BP it was 9?/6?. Was rechecked after 5 minutes. BP was 114/73. Pt still wanted to see MD. Sx resolved when pt left pharmacy.				Y					Y	09/02/2009	09/02/2009	0		OTH	OTH	None	None	Allergic to milk			1						1	Blood pressure decreased; Hyperhidrosis; Lethargy	FLU3~SANOFI PASTEUR~U3185AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0356855	09/09/2009	NY	39.0	39		F	09/09/2009	1 1/2 hrs after immunization (flu) c/o itching all over body. 11:30 am self-medicated - Benadryl 50 mg. Symptoms subsided.									Y	09/09/2009	09/09/2009	0	None	OTH	PVT	None	None	Allergies - food			1						1	Pruritus generalised	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960301P~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0356858	09/09/2009	OR	58.0	58		F	09/03/2009	Pt arm 4 cm x 3.5 cm red, raised, hot oval. Lt arm 5 cm x 5.5 cm red,raised hard hot oval (Both were given with an injection gun). Pain when touched, itches (can be felt under skin). Blister at site.									Y	09/02/2009	09/03/2009	1	L arm formed a blister at site after 48 hours; R arm bruised after 48 hours	OTH	OTH		None	Rheumatoid Arthritis; Asthma			1						1	Contusion; Erythema; Induration; Injection site vesicles; Oedema peripheral; Pain in extremity; Pruritus; Skin warm	FLU3~SANOFI PASTEUR~U3203AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0982X~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0356860	09/09/2009	MA	46.0	46		F	09/09/2009	15 min. post vaccine, reported red blotchy rash ant. abdomen, upper and lower arms bilaterally and mild itchy throat. Benadryl 50mg po and Albuterol inhaler given. Escorted to ED. ED admin. IV Solumedrol, epinephrine, nebulizer Rx, Recovering well.				Y					Y	09/09/2009	09/09/2009	0		PVT	PVT	Albuterol prn mild asthma	None	Seasonal			1						1	Rash erythematous; Rash macular; Throat irritation	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA448CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0356862	09/09/2009	CA	69.0	69		F	09/09/2009	Swelling of entire left arm. Pressure and pain, red, and warm. Treatment by ice and Benadryl 25 mg q 6 h.									N	09/08/2009	09/08/2009	0		OTH	OTH		None	None			1						1	Discomfort; Erythema; Oedema peripheral; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~U3185AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1296X~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0356896	09/09/2009	IL	69.0	69		M	09/09/2009	Localized reaction to flu shot. 5:25PM 9/9/09. Swelling at site. Applied ice and observed. Pt had no pain no dizziness no S.O.B. Observed 45 minutes. Called MD. MD prescribed BENADRYL 50mg & told pt to go home. Told pt to go to emerg. room if worse or S.O.B.									U	09/09/2009	09/09/2009	0		OTH	PUB						1						1	Injection site swelling; Local reaction	FLU3~SANOFI PASTEUR~U3187AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356897	09/09/2009	IL	51.0	51		F	09/09/2009	Patient received influenza vaccination on 9/3/2009. On 9/4/2009 arm was red, warm to touch at site. No hardness felt itchy to patient took BENADRYL. No resp distress. Dr. stated hives.									Y	09/03/2009	09/04/2009	1	None	MIL	OTH						1						1	Injection site erythema; Injection site pruritus; Injection site warmth; Urticaria	FLU3~SANOFI PASTEUR~U3196AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356905	09/10/2009	NJ	46.0	46		F	09/04/2009	Initial report was received 26 August 2009 from a health care professional, who is also the patient. A 46-year-old female patient with a history of asthma and allergies to codeine and Tetanus Toxoid, had received a 0.5 ml left deltoid intramuscular injection of FLUZONE SV 2009-2010, lot number U3200AA on 21 August 2009 and eight hours later, she developed a laryngospasm and had a funny feeling described as lightheaded. The patient self medicated with an Epipen with clearance of symptoms. The patient had no concurrent illness at the time of vaccination. On 25 August 2009, four days post vaccination, the patient developed a temperature of 101 degrees, muscle aches and congestion. The patient was evaluated by a physician who noted that her lungs were clear and additional testing had not been performed. The patient had a history of 20 prior FLUZONE vaccinations. At the time of the report, the patient's recovery status was reported as unknown. Documents held by sender: None.				Y					U	08/21/2009			None	PVT	UNK	ADVAIR		The patient had no illness at the time of vaccination and she had a past history of asthma, and allergies to Codeine and Tetanus Toxoid.		200903673	1						1	Body temperature increased; Dizziness; Laryngospasm; Myalgia; Upper respiratory tract congestion	FLU3~SANOFI PASTEUR~U3200A~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0356910	09/10/2009	VA	44.0			F		With 24 hrs of receiving AFLURIA 0.5ml IM vaccine, patient reports she had several areas of large flat blotchy areas on her face and neck. Also reports itching in the blotchy areas. Used OTC hydrocortisone cream on her own. No other meds. On day 4 symptoms subsiding. No meds nor report to PMD. No fever, no SOB, no muscle aches, no other sx except red blotches.									Y					OTH	PVT	None	None				1						1	Pruritus; Rash erythematous; Rash macular	FLU3~CSL LIMITED~~1~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0356912	09/10/2009	CT	0.33	0	.3	F	09/03/2009	4 month old given inactivated flu vaccine 0.25ml (for 6 months - 36 months age range). Correct dosing but 2 month early. Weight at time of visit = 12 lb 10 oz, healthy term baby, no complication since birth. Here for routine WCC.									Y	09/03/2009			None	PVT	PVT	None	For well child care	None			1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U3167FA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF599AB~2~IM~LL~HIB (ACTHIB)~1	USA		Influenza
0356913	09/10/2009	GA	46.0	46		F	09/03/2009	Eye itch night of day of injection. Face swollen next morning.									U	09/02/2009	09/02/2009	0		PVT	UNK	SEASONALE (BCP)	None				1						1	Eye pruritus; Swelling face	FLU3~SANOFI PASTEUR~U3200AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356918	09/10/2009	MA	17.0	17		F	09/04/2009	Patient reports feeling nauseated approx 2-3 hrs after flu vaccine. Vomited from 3AM 9/3 - 6AM. Also complained of headache. Self resolved no further vomiting or nausea; headaches continued.									Y	09/02/2009	09/03/2009	1		PVT	PVT	TRISPRINTEC	none				1						1	Headache; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U3209AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356919	09/10/2009	NJ	1.08	1	.1	M	09/10/2009	Had syncopal episode at home. Fell - stopped breathing x20 seconds. Then was postictal x20 seconds - ? primary seizure vs breath-holding episode.				Y					Y	09/09/2009	09/09/2009	0		UNK	PVT	None	None	None			1						1	Fall; Postictal state; Respiratory arrest; Syncope	FLU3~SANOFI PASTEUR~UT31744A~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0356922	09/10/2009	SC	58.0	58		F	09/10/2009	Had vaccine at 6p, dry cough and headache by 9p, chest tight/sore throat,chills, sweating and fever of 102 degrees all night, woke with nasal congestion but by 10a all symptoms subsided.  No reaction at shot location.									Y	09/09/2009	09/09/2009	0		UNK	PVT	None	None/Body Temp 98.3				1						1	Chest discomfort; Chills; Cough; Headache; Hyperhidrosis; Nasal congestion; Oropharyngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~1~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356925	09/10/2009	NM	39.0	39		F	09/10/2009	rash/hives rt upper arm and upper back, bilateral forearms (back side) and bilateral upper legs/thighs									Y	09/09/2009	09/09/2009	0		PVT	UNK	None	head cold	None known			1						1	Rash; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97845P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0356926	09/10/2009	WA	55.0	55		F	09/10/2009	I received a flu shot from walk-in facility. They gave me Fluzone. I have never before had a reaction to flu vaccines, but the flu vaccines that I had were all out of state. This was my first one in state. Within half an hour both of my ears began to ring and I began losing my hearing. I estimate hearing loss at about 15%. I developed a feeling of fullness in my ears, they were also painful, and they felt itchy/prickly somewhere way inside my ear. My ears began to hurt. I called my doctor and she said to call the ear doctor she recommended. I went in to see the ear doctor immediately. He said that I had an allergic reaction to the shot, that he had seen this before. If my ears are not better today, I am to see him again and get a prescription. My ears still hurt and feel full.				Y					U	09/09/2009	09/09/2009	0		UNK	UNK						1						1	Deafness; Ear discomfort; Ear pain; Hypersensitivity; Pruritus; Tinnitus; Hypoacusis	FLU3~SANOFI PASTEUR~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U3196AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0356926	09/10/2009	WA	55.0	55		F	09/09/2009	Pt. called about 40 min. after shot given (at home) and reported her hearing decreased and felt like someone put water in her ear; feel full Asked if pt. is allergic to anything else beside what are listed on consent form. She did said no. Told her to watch out for s/s of anaphylactic rxn (shortness of breath, rashes, swelling etc., and monitor whether healing is worst or better , pt. understand and she said has no other problems. I told pt. I'll call back to check on her. Called at 5:29 PM on 9/9/09 but got no answer - left message and will call back pt. again the next day. I called again 9/10/09 at 9:21 AM and got no answer. Left message.									U	09/09/2009	09/09/2009	0		OTH	OTH						1						2	Deafness; Ear discomfort; Ear pain; Hypersensitivity; Pruritus; Tinnitus; Hypoacusis	FLU3~SANOFI PASTEUR~~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U3196AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0356927	09/10/2009	NE	1.15	1	.1	F	09/10/2009	Initial low grade temp (99F) treated with Tylenol within 3 hours of injections. Within 10 hours, high temp of 103. Extreme restlessness, rapid breathing, back arching (as if in pain). Inconsolable crying/screaming. Extreme thirst. Piggybacked Tylenol with Advil. Temp brought down to moderate. Reported to child's pediatrician's nurse.									Y	09/09/2009	09/10/2009	1	None performed.	UNK	UNK		None.	None.			1						1	Body temperature increased; Crying; Opisthotonus; Respiratory rate increased; Restlessness; Screaming; Thirst	FLUX~UNKNOWN MANUFACTURER~~1~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~1~IM~LL~HEP A (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~4~IM~RL~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~4~IM~LL~PNEUMO (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~1~IM~RL~VARICELLA (NO BRAND NAME)~1	USA		Influenza
0356929	09/10/2009	ID	32.0	32		F	09/10/2009	Flu vaccination was given to me on Sept 1st.  On Sept. 7th, I became extremely dizzy and nauseated.  The symptoms continued until Sept 9th.  I made an appt. to see urgent care at the Medical Center.  The nurse practitioner said I had labyrinthitis/vertigo which usually follows a viral infection or a flu or your bodys immune response to fight off a virus or flu.  I have no symptoms of an upper respiratory infection and no other symptoms besides dizziness and nausea.  I am currently not experiencing any dizziness at this time.				Y					U	09/01/2009	09/07/2009	6	All laboratory tests were normal.  Bun and Creatinine were normal.  Dehydration was ruled out.  Temperature was 99.1 (slightly elevated).  Blood pressure normal.  Heart rate was normal.  Physical examination was normal.  Pregnancy was ruled out.	MIL	MIL	flaxseed oil 2000mg per day, vitamin B6 tablet once a day, Prozac 20 mg once a day (on medication for 5 wks before vaccination given, no side effects and nurse practitioner ruled out medication as possible cause of dizziness/nausea).	No illnesses at time of vaccination				1						1	Blood creatinine normal; Blood urea normal; Body temperature increased; Dizziness; Laboratory test normal; Labyrinthitis; Nausea; Vertigo	FLU3~CSL LIMITED~7349111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0356931	09/10/2009	NY	74.0	74		F	09/10/2009	Returned to clinic 9-9-09 with a red raised vesicles rash in dermatomal distribution on left lower back radiating around to center of lower abdomen. Onset of rash about 9-7-09. Patient denies pain or itching fever or chills. Tx valtrex 1gm TID X 7 days										09/02/2009	09/07/2009	5		PUB	PUB	acetaminophen atenolol, glipizide, HCTZ, lisinopril, methocarbamol,pioglitazone, simvastatin, vardenafil, aspirin	none	obestity, HTN, PVD, DJD, diverticulitis, hyperlipid, onychomycosis, BPH, low back pain, chronic kidney dz			1						1	Rash erythematous; Rash vesicular	FLU3~CSL LIMITED~07649111a~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|VARZOS~MERCK & CO. INC.~1791X~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0356933	09/10/2009	MI	37.0	37		F	09/10/2009	Pt was given double dose of flu vaccine. Next morning complained of arm pain radiating into breast area. Sent to Occupational Health facility for follow up.				Y					Y	09/09/2009	09/09/2009	0		PVT	PVT		None	Reflux, Asthma, environmental allergies, food allergies-milk and eggs (pt is a physician assistant and stated the egg allergy was not an issue as she has had flu vaccine in the past and wanted to proceed).			1						1	Breast pain; Incorrect dose administered; Pain in extremity	FLU3~SANOFI PASTEUR~U3207AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0356934	09/10/2009	MI	36.0	36		F	09/10/2009	Pt given double dose of flu vaccine-no adverse reaction.									Y	09/09/2009	09/09/2009	0		PVT	PVT	Flonase	None				1						1	Incorrect dose administered; No adverse event	FLU3~SANOFI PASTEUR~U3207AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356935	09/10/2009	MI	49.0	49		F	09/10/2009	Pt given double dose of flu vaccine-no adverse reaction.									Y	09/09/2009	09/09/2009	0		PVT	PVT		None				1						1	Incorrect dose administered; No adverse event	FLU3~SANOFI PASTEUR~U3207AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356940	09/10/2009	CA	2.0	2	.9	F	09/10/2009	Patient ran fever of 100-102 for 3 days. Treated successfully with Tylenol. Moderate rash appeared on day 5 after onset of initial fever. Rash covered trunk, limbs, and face, was red and spotty but not raised or weepy.									N	08/26/2009	09/06/2009	11		UNK	UNK	none	none	none	fever of 104~Measles + Mumps + Rubella (no brand name)~1~1.30~Sibling		1						1	Erythema; Pyrexia; Rash generalised	FLUX~UNKNOWN MANUFACTURER~~1~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~1~IM~RL~HEP A (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~1~ID~LA~TETANUS TOXOID (NO BRAND NAME)~1|VARCEL~MERCK & CO. INC.~~1~IM~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0356941	09/10/2009	GA	36.0	36		F	09/10/2009	Roughly 10 minutes after injection, felt wave of dizziness which then lead to extreme blurriness, some difficulty breathing, clammy skin all over.  Extreme blurriness only lasted for a couple minutes, but basically could not see anything. (could see light outside, but no definition)  Rest of reaction lasted approximately 10-15 minutes. Never had reaction to previous flu shots and this is the fourth one I've received at this very location.  Only difference I've noticed when looking at previous paperwork is that all the other times I received the preservative-free shot while this time I got the one with preservatives because the other was not available.									Y	09/10/2009	09/10/2009	0	n/a	UNK	UNK	none	none	none			1						1	Cold sweat; Dizziness; Dyspnoea; No reaction on previous exposure to drug; Vision blurred	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356942	09/10/2009	TX	17.0	17		M	09/10/2009	Approximately 4 hours after vaccine administered patient reported:Visual changes including letters appearing in different sizes, unsteady gait, muscle weakness and unusual sensation in hands while typing. Patient went to emergency room for evaluation. Patient was contacted on 9/10/09 and symptoms resolved.				Y					Y	09/09/2009	09/09/2009	0		UNK	PVT			Friedreich's Ataxia Diagnosed March 2009			1						1	Gait disturbance; Muscular weakness; Paraesthesia; Visual impairment	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0356944	09/10/2009	TX	32.0	32		F	09/10/2009	Itchy arms and chest. No hives or bumps.Benadryl 25 mg, PO given.									Y	09/10/2009	09/10/2009	0		MIL	PVT	n/a	none	seasonal allergies			1						1	Pruritus	FLU3~CSL LIMITED~05749111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0356947	09/10/2009	IN	46.0	46		F	09/10/2009	Influenza shot was received at 3:25 pm.  Around 5:30, a cough began.  Around 6:30 hoarseness and a funny feeling began in the throat.  By 7:30 was thinking of going to the hospital.  Call Hospital at 8:00 and was instructed to take benadryl.  Took 2-25 ml pills around 8:10.  Call hospital again around 8:30 to report difficulty swallowing.  Arrived at hospital around 8:50.  Elevated blood pressure and shaking on arrival.  Admitted to ER and received a breathing treatment and steroid shot.  Dismissed from hospital around 10:15.				Y					Y	09/09/2009	09/09/2009	0	allergic reaction from influenza vaccine	UNK	UNK						1						1	Blood pressure increased; Cough; Dysphagia; Dysphonia; Feeling abnormal; Hypersensitivity; Throat irritation; Tremor	FLUX~UNKNOWN MANUFACTURER~~1~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0356949	09/10/2009	CO	62.0	62		F	09/10/2009	vomiting, nausea, diarehha, chills, body aches, headaches within four hours of receiving vaccine				Y					Y	09/09/2009	09/09/2009	0	visited doctor, no tests	UNK	PVT	lisinopril, hydrochlorothiazide, maxide, atenolol, probenecid, baby aspirin	none	Iodine allergy, essential hypertension, gout, asthma	nausea, weakness, aches~Influenza (Seasonal) (no brand name)~1~61.00~In Patient		1						1	Chills; Diarrhoea; Headache; Nausea; Pain; Vomiting	FLU3~SANOFI PASTEUR~Unknown~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0356957	09/10/2009	CA	76.0	76		F	09/10/2009	Patient was given 0.5ml of Influenza vaccine, IM @ 1405 in L deltoid. Patient was starting to leave clinic and said she felt lightheaded and dizzy, @ 1406 we had patient lay down and monitor BP x 20 minutes.									Y	09/10/2009	09/10/2009	0	BP @ 1407 130/80; BP @ 1410 160/82; BP @ 1425 164/82	PVT	PVT		Diarrhea; Weight loss	Penicillin Allergy; Emphysema; High BP; Renal Failure			1						1	Blood pressure decreased; Dizziness	FLU3~SANOFI PASTEUR~U3196AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356958	09/10/2009	NY	20.0	20		F	09/06/2009	1 minute after administering FLUENZA patient loss (1:00pm) consciousness for approximately 3 minutes. She was non responsive for 1 minute and not coherent for another 2 minutes. Her breathing and pulse were stable ambulance was called she was checked by an EMT and cleared to return to work. She has no lasting effects or injuries from the event to date. (3:45pm 9/6/09)									Y	09/06/2009	09/06/2009	0	Blood Pressure, stable	OTH	PVT						1						1	Blood pressure normal; Loss of consciousness; Unresponsive to stimuli	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0356959	09/10/2009	WA	26.0	26		F	09/10/2009	Raised, red, warm to touch bilateral arm injection sites. Size of 'Golf ball'.										09/08/2009	09/09/2009	1		PVT	UNK	DEPO-PROVERA; PROCTOFOAM	Not ill- 9/9/09	NKDA - None			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~CSL LIMITED~05749111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~1296X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0356960	09/10/2009	KS	9.0	9		F	09/10/2009	Mother presented child for flu vaccination. Mother reports that she takes flu shot annually, with no previous reaction. Vaccine administered. Child began itching skin @ site before leaving clinic. Last eve. injection site became reddened- this A.M. area of redness @ site was 5 cm and circular. Warm and mod. firm. Mother reports she saw vaccine run out of injection site @ time of injection into skin. Advised application of ice pack several x today and take TYLENOL po 3 tsp. every 4 hrs prn discomfort.										09/09/2009	09/09/2009	0	Wt - 103#; Oral Temp - 97.4	PUB	PVT		none	asthma			1						1	Injection site erythema; Injection site extravasation; Injection site induration; Injection site pruritus; Injection site warmth	FLU3~SANOFI PASTEUR~U3200AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356961	09/10/2009	AZ	56.0	56		M	09/14/2009	Left deltoid region became erythematous, warm & induration following immunization.  Systemic fatigue.  Began to improve 48 hours later. Pt believes it was @ location of PNEUMOVAX.									Y	09/01/2009	09/01/2009	0		PVT	UNK						1						1	Fatigue; Injection site erythema; Injection site induration; Injection site warmth	FLU3~SANOFI PASTEUR~U3190AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1162X~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0356963	09/10/2009	CA	1.01	1	.0	F	09/10/2009	Left thigh with 3 areas of raised pink sersiginous raiser border and flat center and left buttock with larger 2 inch confluent raised pink module; smaller raised pink papule her right shoulder and thigh. Started on BENADRYL 12.5mg/5ml syrup 5ml, 100q 6hrs for 2 days, follow up PRN. 9-11-09 per phone call pt much better.									Y	09/08/2009	09/10/2009	2	None	PVT	PVT	None	None	None			1						1	Injection site erythema; Injection site nodule; Injection site papule; Injection site swelling	FLU3~SANOFI PASTEUR~UT3173GA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF567AA~4~IM~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0529U~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~D75884~4~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0356964	09/10/2009	AK	16.0	16		F	09/10/2009	6x7 cm erythema at injection site left arm.  No temperature, swelling at injection site.									Y	09/09/2009	09/10/2009	1	WBC 22.3;  GRAN 89.0 (Drawn 9/9/09 after visit)	PVT	OTH		Elevated WBC count				1						1	Granulocyte count increased; Injection site erythema; Injection site swelling; White blood cell count increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97849P1~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARCEL~MERCK & CO. INC.~0810Y~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0356966	09/10/2009	NC	76.0	76		M	09/10/2009	Once I gave shot, his arm immediately swelled up, local irritation + redness w/ minimal bleeding.  Pt. did not feel dizzy or have any other adverse effects.  Pt. upon follow up 4 hours later stated swelling was down and he felt great.									Y	09/10/2009	09/10/2009	0		OTH	PUB	Unknown	None	None			1						1	Erythema; Haemorrhage; Immediate post-injection reaction; Local reaction; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0356967	09/10/2009	NE	66.0	66		F	09/10/2009	In ER  1 am had a fever 103. Diagnosed with cellulitis. Gave antibiotics in IV and was given LEVAQUIN and Doxycycline is recovering. Also had swollen arm.				Y					Y	09/07/2009	09/07/2009	0	Blood work	OTH	UNK		None				1						1	Blood test; Cellulitis; Oedema peripheral; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840PI~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0627Y~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0356968	09/10/2009	VA	47.0	47		F	09/10/2009	The pt states in approx. 2005 while working on the postpartum ward as an RN she received a FLUMIST vaccination. Initially, the pt reported that she had received Influenza IM but has since recalled that it was FLUMIST. The pt states she immediately had burning in her sinuses. At the end of the shift (7PM) the pt noted that she was fatigued, had a headache, felt feverish and had nasal congestion. The next day the pt went to work and was so fatigued that she fell asleep at the nurse's station so she went home. The symptoms continued and additionally she developed a productive cough and chest discomfort when she coughed. The pt treated herself with OTC medications. The fatigue, fever, headache, nasal congestion lasted 3-4 days. The cough lasted 3-4 weeks. The pt did not seek medical attention. At the time there were no other sick family members and no co-workers who were ill with similar symptoms. Symptoms: Pain, Fatigue, Malaise >60 Days, Fever, Headache, general, Cough productive.									Y	01/03/2005	01/03/2005	0		MIL	MIL	none	none	none			1						1	Activities of daily living impaired; Burning sensation; Chest discomfort; Cough; Fatigue; Feeling hot; Headache; Immediate post-injection reaction; Malaise; Nasal congestion; Productive cough	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0356969	09/10/2009	MN	58.0	58		F	09/10/2009	Sore Throat, swollen tonsils, T 100.2, body aches and cough, Txed with PREDNISONE and TAMIFLU.				Y						09/03/2009	09/06/2009	3	Crp 8.40 911ccl 127 (normal on 9/10/09)AST Co4 ALT 94 (38 & 52 on 9/10/09) (>) quick strep 7.4, 15.2, 275	PVT	UNK	FLUOXETINE, FLUTICASONE, KETOCONAZOLE, LISINOPRIL-HCTZ, METAMUCIL	None	HTN, NASH/fatty liver allergy to FEXOFENADINE (increased LFB & liver pain).			1						1	Alanine aminotransferase increased; Aspartate aminotransferase; Body temperature increased; C-reactive protein increased; Cough; Laboratory test; Oropharyngeal pain; Pain; Streptococcal identification test negative; Tonsillar hypertrophy	FLU3~SANOFI PASTEUR~U3203AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1648X~3~IM~RA~HEP B (RECOMBIVAX HB)~1	USA	Emergency room visit	Influenza
0356970	09/10/2009	OR	43.0	43		M	09/10/2009	Raised red area silver dollar size hot to touch.									Y	09/09/2009	09/09/2009	0	None	UNK	UNK						1						1	Rash erythematous; Skin warm	FLU3~CSL LIMITED~05749111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0356988	09/11/2009	MD	43.0	0	.5	F	09/11/2009	Body itching, eyes swollen shut, red itching eyes, stomach aches, body aches, cough hoarness, sore throat, runnning nose.									U	09/10/1966	09/10/1966	0	N/a	MIL	UNK		None	Allergies to strawberry, eggs, outside and inside, sinusitis, border line diabetes.			1						1	Abdominal pain upper; Cough; Dysphonia; Eye pruritus; Eye swelling; Ocular hyperaemia; Oropharyngeal pain; Pain; Pruritus; Rhinorrhoea	FLU3~SANOFI PASTEUR~113176AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356989	09/11/2009	GA	55.0	54		M	09/11/2009	Inability to concentrate, cognitive difficulty, malaise									Y	09/08/2009	09/09/2009	1		PVT	PVT	none	none	allergic to sulfa			1						1	Cognitive disorder; Disturbance in attention; Malaise	FLU3~SANOFI PASTEUR~U3197AB~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356990	09/11/2009	MD	20.0	20		M	09/11/2009	Generalized rash and puritis developed approximately 90 minutes after recieving a dose of FluMist.				Y					Y	09/10/2009	09/10/2009	0	None	UNK	MIL	Bacitracin 500U/g topical ointment. Hydocodone/Acetaminophen 7.5-500mg PRN.	None	Acne. Metatarsalgia. No known allergies.	none~ ()~NULL~~In Patient|unknown~ ()~NULL~~In Sibling1|unknown~ ()~NULL~~In Sibling2		1						1	Pruritus generalised; Rash generalised	FLUN3~MEDIMMUNE VACCINES, INC.~500691p~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0356993	09/11/2009	NC	6.0	6		F	09/11/2009	Pt left office, vomit x1 on the way home. Mom reports she was pale and complaints of nausea and then vomit x1.									Y	09/09/2009	09/09/2009	0		PVT	PVT						1						1	Nausea; Pallor; Vomiting	FLU3~SANOFI PASTEUR~U3177AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0356998	09/11/2009	TX	29.0	29		M	09/11/2009	Complete loss of appetite. Body chills and aches. Headache and significant fever. Beginning six hours after shot administered and worsening over next six hours until I took 4 advils. Fever broken about 2 am.									Y	09/10/2009	09/10/2009	0		PVT	UNK						1						1	Chills; Decreased appetite; Headache; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0357000	09/11/2009	TX	54.0	54		M	09/11/2009	Patient first experienced headache and posterior neck pain that lasted approximately 48 hours.  Following that he developed severe cervical neck pain that lasted 1.5 hours.  The pain then traveled down his spine and was accompanied by allodynia, both of which lasted approximately 48 hours.  By the afternoon the patient experienced pain and allodynia all down his back, into the posterior of his legs, throughout his hips, and into his knees.				Y					Y	09/03/2009	09/03/2009	0	Upon examination a blood test showed WBCs within normal limits.  Patient's vitals were checked and the patient had a temperature of 99.8 (from 96.5 at time of vaccination.)  Also a flu A&B swab was done and was negative.	UNK	UNK	None	None	Chronic neck pain; spondylosis of lumbar region.			1						1	Allodynia; Back pain; Headache; Influenza serology negative; Neck pain; White blood cell count normal	FLU3~CSL LIMITED~07549111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0357001	09/11/2009	AK	52.0	52		F	09/11/2009	2 inch diameter redness, slight swelling and warmth at site									Y	09/09/2009	09/11/2009	2		PUB	PVT						1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLUX~SANOFI PASTEUR~U3173BA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0357002	09/11/2009	MT	60.0	60		F	09/11/2009	Pt received Flu vaccine and pneumovax in right arm.  Not sure which site was which vaccine.  The lower injection site has a reddened slightly raised, hot area 3 in diameter. Below it, in the inner elbow area is an area of red, hot raised, tender tissue about 4 in diameter.  Pt c/o fever and chills 9/10 pm and was seen in ER by Dr. who called it a cellulitis-like reaction.  Pt is taking Benadryl, tylenol and using ice to the area.  The right arm has decreased mobility due to this.  Temperature last night in ER was 99.3F and this a.m. was 99.5F. At time of vaccination, pt stated she had not had pneumonia vaccine previously.  She stated today that after her vaccination she went home to find her shot record and found that she HAD had a pneumonia shot 7/20/04.  She has celiac sprue disease and stated she wanted to be sure that her immune system was protected since she had this diagnosis.				Y					U	09/09/2009	09/09/2009	0	None	UNK	UNK		None	Celiac Sprue Disease	None~ ()~~0.00~Patient		1						1	Chills; Injected limb mobility decreased; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U3185AA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0224X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|TD~SANOFI PASTEUR~C3351AA~UNK~IM~RA~TD ADSORBED (TENIVAC)~1	USA	Emergency room visit	Influenza
0357003	09/11/2009	OH	78.0	78		F	09/11/2009	Right arm (inside bicep) was slightly swollen and red, approx 2 inches in diameter. No itching. Patient could not move arm past shoulder height. Painful to touch. Occurred 1 day after vaccination (on 9/10/09). Pharmacist gave diphenhydramine and acetaminophen when notified on 9/11/09.									U	09/09/2009	09/10/2009	1	n/a	PUB	PVT	n/a	none	n/a			1						1	Injected limb mobility decreased; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~u3209aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1125x~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357005	09/11/2009	PA	1.5	1	.6	M	09/11/2009	My son had fever 99.1 degree last night after received the flu shot.  I gave him Tylenol around 9pm.  In the midnight, he developed fever again.  I gave him Motrin around 2am this morning.  This morning, he still had low-grade fever around 99.  I have reported this adverse event to his doctor's office this morning.									N	09/10/2009	09/10/2009	0	None	PVT	UNK	Fluoride drops		None			1						1	Pyrexia; Cough; Insomnia; Nasal congestion; Pyrexia; Rhinorrhoea; Tremor; Vomiting	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U3167F~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0357019	09/11/2009	NV	71.0	71		F	09/03/2009	Guillain-Barre Syndrome - LE Weakness, visual disturbance. 12/07/09 DC summary, ED and Hospital records received for DOS 01/19/08-01/21/08. Presented with lower extremity weakness x 1 week. Weakness started in calves and then developed difficulty walking up stairs. H/o muscle tenderness x 1 month. Neurology consult, Rehabilitative medicine consults obtained. Discharged home with walker and outpatient PT, OT. DC DX: Guillain-Barre syndrome					Y	2		Y	N	10/30/2007	12/22/2007	53	12/07/09 Diagnostics: CT scan of head: negative; Lumbar spine CT: disc degeneration at L4-L5 level; MRI of brain: mild age-appropriate cerebral atrophy, possible small vessel ischemic disease ; MRI of thoracic spine: thoracic degenerative disc disease; MRI of lumbar spine: minimal disc bulging, mild  canal stenosis at L4-L5; CXR: mild cardiac enlargement, otherwise normal;  EMG/ Nerve conduction studies consistent with Guillain-Barre syndrome; Spirometery: normal, EKG: normal; HGB 12.3 (L); HCT 34.4 (L); Lymphocytes% 61 (H).	PUB	UNK		None	12/07/09 PMH: allergic to codeine, tetracycline; Naprosyn; hypothryoidism, dyslipidemia			1						1	Guillain-Barre syndrome; Muscular weakness; Visual impairment	FLU3~SANOFI PASTEUR~U2488AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0964U~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation,Disabling	Influenza
0357020	09/11/2009	OH	2.0	2	.0	M	09/04/2009	Febrile seizure 7 days after HIB and FLUMIST. 11/25/09 Medical records received for date 9/1/09 and 9/4/09. DX: Wellness exam WNL. 9/4/09 Pt seen in office w/ c/o fever after vaccination. Rash on face, parent states started convulsing and was taken to ER and OV today for f/u. Assessment WNL except (+)fever, cough, rash, congestion. DX: febrile seizure.				Y					Y	09/01/2009	09/03/2009	2	CBC	PVT	PVT	Claritin PRN	None	2 previous febrile seizures			1						1	Condition aggravated; Febrile convulsion; Full blood count	FLUN3~MEDIMMUNE VACCINES, INC.~500677P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HIBV~SANOFI PASTEUR~UF692AA~4~IM~RA~HIB (ACTHIB)~1	USA	Emergency room visit	Influenza
0357022	09/11/2009	IN	56.0	56		F	09/04/2009	Received shot around 2pm 9/2. Approximately 6pm experienced numbness in mouth & throat for approx. 3 hrs. Also, then developed runny nose, sore throat, fatigue & red eyes.									Y	09/02/2009	09/02/2009	0		PVT	PVT	Lisinopril - HCTZ; Oxaprizin-600mg					1						1	Fatigue; Hypoaesthesia oral; Ocular hyperaemia; Oropharyngeal pain; Pharyngeal hypoaesthesia; Rhinorrhoea	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0357023	09/11/2009	CA	15.0	15		F	09/04/2009	Pt came back on 9/3 (1 day later) with rash throughout body.  Pt also complained of warmness thru the night of 9/2.  Pt went to clinic on 9/3 & was given BENADRYL & TAC 1%.				Y					Y	09/02/2009	09/02/2009	0	Unknown	OTH	PVT		Warmness feeling	Unknown			1						1	Feeling hot; Rash generalised	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357027	09/11/2009	NM	72.0	72		F	09/03/2009	Gave too low - fluid went into tissue. Red, itching & raised. Pt went to doctor - doctor stated vaccine given too low - pt will recover and is immunized.									Y	09/01/2009	09/02/2009	1	None taken	UNK	PVT		None	None			1						1	Drug administered at inappropriate site; Erythema; Pruritus; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357030	09/11/2009	DE	71.0	71		F	09/02/2009	Received pneumonia shot at 3:30 pm on September 1, 2009 on right arm. About 6 pm arm started to get red and swell and hurt. Patient cannot lift arm. Put ice on area and took BENADRYL. Arm is worse today September 2, 2009.									Y	09/01/2009	09/01/2009	0		OTH	UNK	LISINOPRIL	No	No	No~ ()~~0.00~Patient		1						1	Injected limb mobility decreased; Injection site erythema; Injection site pain; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1296X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357033	09/11/2009	IL	3.0	3		F	09/11/2009	Swallowing dysfxn and annuciation difficulties, for 3-5 days post INFLUENZA vaccination.									Y	09/05/2009	09/06/2009	1		PVT	OTH	None	None	Hgb, trait			1						1	Dysphagia; Speech disorder	FLU3~SANOFI PASTEUR~U3191AA~6~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357037	09/11/2009	CA	10.0	10		F	09/03/2009	Tingling sensation of (L) arm lasted approximately 21/2 - 3 hours after flu vaccine was given.									Y	09/02/2009	09/02/2009	0	None	PVT	UNK		None	None			1						1	Paraesthesia	FLU3~SANOFI PASTEUR~U3203AA~2~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357045	09/11/2009	UT	55.0			F	09/11/2009	Severe sore throat, extreme red eyes, body aches, temp of 101.1, headache, chills, dry cough, hoarseness. Took holistic cold?flu medication and went to bed									U					UNK	PVT		none				1						1	Body temperature increased; Chills; Cough; Dysphonia; Headache; Ocular hyperaemia; Oropharyngeal pain; Pain	FLUX~SANOFI PASTEUR~U3196 AA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0357047	09/11/2009	TN	21.0	21		F	09/11/2009	PT. EXPERIENCED PAIN,REDNESS AND SWELLING AT INJECTION SITE AND ITCHING.REDNESS MEASURES APPROX. 6 CENTIMETERS. WARM TO TOUCH. PT. COMPLAINS OF INCREASED WEAKNESS.									U	09/09/2009	09/09/2009	0		PUB	PUB		PT. HAS HISTORY OF GLAUCOMA.	KEFLEX,CECLOR. PT HAS GLAUCOMA.			1						1	Asthenia; Injection site erythema; Injection site pain; Injection site pruritus; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3195AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357049	09/11/2009	MN	37.0	37		F	09/11/2009	Patient reports feeling fine after injections.  Around 11 AM she became dizzy and lightheaded while driving. She hit a light pole as a result of momentarily blacking out while driving.				Y					Y	09/10/2009	09/10/2009	0	No labs were performed on her doctor visit on 9.10.09.	PVT	PVT	budesonide (RHINOCORT AQUA) 32 MCG/ACT NASAL SUSP          cetirizine-pseudoephedrine (ZYRTEC-D) 5-120 MG	None				1						1	Dizziness; Loss of consciousness; Road traffic accident	FLU3~SANOFI PASTEUR~U3204AA-5763~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~9722200-1263x~3~IM~LA~HEP B (RECOMBIVAX HB)~1	USA	Emergency room visit	Influenza
0357050	09/11/2009	GA	29.0	29		F	09/11/2009	redness, swelling, and warmth at site, site is painful to palpation									Y	09/09/2009	09/10/2009	1		PUB	PVT	BCP	None	none	none~ ()~NULL~~In Patient		1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3204AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0928Y~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0357052	09/11/2009	MI	11.0	11		M	09/11/2009	Large red swollen area on right arm.  Red area is hard and warm to the touch.  First seen by mother on Thursday 9/10/2009.  Went to urgent care evening of 9/10/2009 dx. with cellulitis right bicep tx with omnicef.  Red area increased in size by am of 9/11/2009 went to Pediatrician dx with allergical local reaction tx continue omnicef, benadryl (oral) q 6hrs.  Per mother after leaving peds office child complained of scratchey throat peds office notified advised mother to take to ER.  Sparrow ER dx as local reaction continue tx from above adding benadryl cream, pepcid and steroid.				Y					N	09/09/2009	09/10/2009	1		PUB	PVT			Shellfish, peanuts			1						1	Hypersensitivity; Injection site cellulitis; Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth; Throat irritation	FLU3~SANOFI PASTEUR~U319288~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB286AA~1~IM~LA~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U2906AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0357053	09/11/2009	TN	31.0	28		F	09/11/2009	Onset of weakness and tingling in Left arm 24 hous after receiving flu vaccine.  The vaccine was administered in the Left arm.  The weakness occurred in the forearm and hand.  Described as feeling like pins and poor circulation.  No swelling, no redness. Good capillary refill, color pink. Given Ibuprofen 600 Mg. 1 po q 8 hrs prn.				Y					U	09/04/2006	09/05/2009	1097		PUB	PUB						1						1	Asthenia; Paraesthesia	FLU3~SANOFI PASTEUR~U3195AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357055	09/11/2009	MA	25.0	25		M	09/11/2009	Reports feeling dizzy right after administration but it passed. Next day (during the night or within 12 hours of administration) felt chills,  sore throat described as hard to swallow; nausea in the night but it passed; no vomiting. Symptoms had passed by start of next work day.									Y	09/02/2009	09/03/2009	1	none	PUB	PUB	none	none; reports felt fine	seasonal allergies			1						1	Chills; Dizziness; Dysphagia; Immediate post-injection reaction; Nausea; Oropharyngeal pain	FLU3~SANOFI PASTEUR~u3188Aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357056	09/11/2009	MA	50.0	50		F	09/11/2009	At the time of administrtion, patient stated, My god, this hurts a real lot She states she made that statment as the vaccine was being administered.  At approximatel 6pm or 5 hours after vaccine administered, patient experienced vision problems...problem seeing, blurry, thought I must be getting an infection in my eye, felt nauseous and even when I put on my glasses it did not help. Blurry vision started out of the blue on that evening and continued for several days until Saturday when it got better. Nausea started at the same time, was able to eat lightly; lasted until Saturday. No vomiting. Just wanted to sleep; ended up leaving work early approximately 24 hours after vaccine administered...so tired; too exhausted to work on Friday; felt better by Sunday.									Y	09/02/2009	09/02/2009	0	none	PUB	PUB	Depakoate; aspirin; psych meds	none	Emphysema	Sister is allergic to eggs does not take seasonal flu vaccine~ ()~NULL~~In Sibling1		1						1	Activities of daily living impaired; Fatigue; Injection site pain; Nausea; Vision blurred	FLU3~SANOFI PASTEUR~U3188AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357057	09/11/2009	TX	76.0	76		F	09/11/2009	patient experience swelling/warmness on the injection arm NOT at the injection site, swelling and redness occurred lower on the arm than where the vaccinations were received									U	09/10/2009	09/10/2009	0		UNK	UNK	unknown	none	patient could not receive injections in left arm due to a previous diagnosis, so both injections were given in the same arm and were given about 2 inches apart, however the reaction occured lower down on the arm			1						1	Erythema; Oedema peripheral; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838p2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1435x~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357060	09/11/2009	MN	25.0			M	09/11/2009	Coughing.  Troubles breathing.  Sweating.														PUB	UNK		None	None			1						1	Cough; Dyspnoea; Hyperhidrosis	FLUX~UNKNOWN MANUFACTURER~~2~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0357074	09/11/2009	IL	61.0	61		F	09/11/2009	Patient not feeling well after receiving vaccine. Patient advised to sit down and RPH tended to patient. 911 was called. EMS came and monitored patient. Patient taken to the hospital.				Y					Y	09/11/2009	09/11/2009	0		OTH	PVT		None	None			1						1	Malaise	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357075	09/11/2009	WA	25.0	25		F	09/08/2009	Rashes on face and legs and generalized itching, patient took BENADRYL 25mg Tablets - 1 tab q 4-6 hr. prn : Recovered in two days.									Y	09/08/2009	09/09/2009	1	None	OTH	OTH		None				1						1	Pruritus generalised; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357076	09/11/2009	CA	75.0	75		F	09/09/2009	C/o rash forming a ring approximately 4 inches below site of injection on left arm.  No fever, no difficulty breathing.  L arm is swollen & itches.  Recommended BENADRYL & ice pack to the patient.  (after 24 H, pt still had a rash in the same spot not itchy.)									N	09/09/2009	09/09/2009	0		PUB	PUB			Allergy to high dose NAPROXEN			1						1	Oedema peripheral; Pruritus; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~9783982~2~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0625Y~2~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357077	09/11/2009	OH	55.0	55		U		Patient claims her blood pressure has elevated since the flu shot and she first reported this to me 7 days after the shot.				Y					U	09/03/2009	09/10/2009	7		OTH	OTH		None reported or observed. Pt did have a rash 5 hours before inj.				1						1	Blood pressure increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357083	09/11/2009	MN	4.0	4		F	09/10/2009	Rt thigh redness and swelling developed within 2 days of vaccine (3x5 cm in diameter). Went away and 10 days later recurred with vesicles suggestive of chicken pox in center of redness.									U	08/26/2009	08/28/2009	2		PVT	UNK		None	None			1						1	Injection site erythema; Injection site swelling; Injection site vesicles; Varicella	DTAPIPVHIB~SANOFI PASTEUR~C3228AA~1~IM~RL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~U3200AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0505X~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0733X~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0357085	09/11/2009	CA	66.0	66		M	09/13/2009	Patient received FLUVIRIN flu shot on 9-8-09 and had no adverse reaction. He became swelling on next day 9-9-09. He went to ER & was given PREDNISONE. ER MD suspected may be due to flu shot.									Y	09/08/2009	09/09/2009	1		UNK	PVT		None				1						1	Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848P1C~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357087	09/11/2009	OR	83.0	83		M	09/12/2009	Painful injection site followed with achy arm, rash on trunk, legs and neck. Patient says he has never had a reaction to a flu shot.									Y	09/03/2009				OTH	PUB						1						1	Injection site pain; No reaction on previous exposure to drug; Pain in extremity; Rash	FLU3~SANOFI PASTEUR~U3190AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357089	09/11/2009	NY	16.0	16		F	09/11/2009	Fainting, feeling of coldness and weakness. Same reaction on 02/12/2009 but vaccine was given with other four.										09/10/2009	09/11/2009	1		PVT	PUB						1						1	Asthenia; Feeling cold; Syncope; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U3208AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~1311X~2~IM~RA~HPV (GARDASIL)~1	USA		Influenza
0357091	09/11/2009	OH	13.0	13		F	09/11/2009	Urticaria on face, legs, torso - improved w/ BENADRYL in 24hrs.									Y	09/09/2009	09/09/2009	0	none	PVT	PVT		None	None			1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500693P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0357092	09/11/2009	WI	20.0	20		F	09/11/2009	Patient had hotflush, passed out and became unconscious, when patient came to, felt nauseated, was clammy to touch and hot. Pt was given water and ice pack and put head between legs. After 20 minutes she felt better and left.									Y	09/11/2009	09/11/2009	0		OTH	PVT						1						1	Cold sweat; Hot flush; Loss of consciousness; Nausea; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357093	09/11/2009	PA	66.0	66		M	09/11/2009	Pt got a flu shot in the pharmacy at 6:45 PM on 09/10/09 and had no symptoms of allergy. When pt got home and took Lisinopril at 10AM on the same day then had a reaction swelling throat, difficulty of breathing, rash. Pt went to emergency room and was administered steroid, BENADRYL and was discharged the same night - pt reported he was on Lisinopril for 3 years.				Y					Y	09/10/2009	09/10/2009	0		OTH	OTH	Lisinopril					1						1	Dyspnoea; Pharyngeal oedema; Rash	FLU3~SANOFI PASTEUR~U3184AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357095	09/11/2009	NE	76.0	76		M	09/11/2009	-Redness & swelling injection arm in elbow region & forearm -bruising in injection site.									Y	09/08/2009	09/10/2009	2		OTH	UNK		None	None			1						1	Injection site erythema; Injection site haematoma; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0627Y~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357097	09/11/2009	CA	26.0	26		M	09/11/2009	Pt said he got some itchy hives developed 2 hours later, and it got worse overnight. He took BENADRYL for 2 days then he went to his primary care MD. MD gave him a steroid injection & pt continued taking BENADRYL. Rash has gone or gradually decreased.				Y					Y	09/04/2009	09/04/2009	0	None	OTH	PVT	SINGULAIR 10mg; PROVENTIL HFA MDI (PRN)	Asthma; Influenza prevention	Asthma			1						1	Pruritus; Rash; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357102	09/11/2009	KS	66.0	66		M		Reaction to pneumonia vaccine -arm red - hot - hard - scabbed - client ran fever - achy - felt poorly - started within 24 hours of receiving vaccine - missed work due to fever & symptoms - arm still hard & scabbed.									Y	09/01/2009	09/02/2009	1		PUB	PVT		None	None			1						1	Activities of daily living impaired; Erythema; Feeling abnormal; Induration; Pain; Pyrexia; Scab; Skin warm	FLU3~SANOFI PASTEUR~U3186AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0867~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357108	09/11/2009	RI	30.0	30		M	09/10/2009	Patient very apprehensive re flu vaccine. Told to wait 15 min since it was 1st time to get shot. LPN noticed pt. starting to slump in chair. RN came to aid - put head of pt between knees. Fainted 8 seconds or less then was to verbalize & oriented - diaphoretic AP 84. 911 called pt transported to hospital.				Y					Y	09/09/2009	09/09/2009	0		OTH	UNK						1						1	Hyperhidrosis; Posture abnormal; Syncope	FLU3~CSL LIMITED~02349211A~UNK~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0357119	09/11/2009	CO	76.0	76		F	09/11/2009	Reported to Dr's office on 9-4 arm was inflamed, swollen + warm.  Dr stated localized topical reaction.  Tx w/ BENADRYL - O.T.C  Follow up on 9-8 reaction resolved.				Y					Y	09/02/2009				MIL	OTH		None				1						1	Inflammation; Local reaction; Oedema peripheral; Skin warm	FLU3~SANOFI PASTEUR~U3185AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357042	09/12/2009	WA	49.0	49		F	09/12/2009	redness, warmth, soreness at swelling site about 2-3 inches across.									U	09/10/2009	09/11/2009	1		OTH	OTH		Unknown	NKDA; NKFA			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838PZ~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357061	09/12/2009	WI	4.0	4		M	09/12/2009	Significant irritability, back pain, muscle aches, difficult to console - started morning after vaccine administration, required office visit, ER visit, hospitalization. Resolved within 24 hours with IV ketorolac, morphine, hydration. Also redness and induration (3cm) L thigh at site of MMR and Varicella.  9/17/09 ER record received for DOS 9/11/09 with D/C DX: Excessive crying.  R/O encephalitis.  R/O Immunization reaction.  Backache. The mornng after vax pt c/o leg and back pain, difficulty bearing weight, screaming, feeling hot and cold, chills, tiredness and fever.  PE (+) for refusal to walk, spasm of the paraspinal areas of thoracolumbar spine, mild local reaction at MMR and Varicella vax sites. Observed o/n and d/c.					Y	1			Y	09/10/2009	09/11/2009	1	WBC 9.5, 72% neutrophils; CMP normal, UA normal, CXR including spine normal, Lyme negative; CSF 0 WBC, 0 RBC, protein 26, glucose 61, gran stain negative, culture and viral cultures pending Labs:  Blood culture (-). CSF cx and gram stain (-). Lyme (-). CSF all WNL.  Glucose 107.  Alk Phos 335 (H).  CBC WNL.  Neutros 72% (H). Lymphs 18% (L). Monos 8% (H).	UNK	UNK		none	none PMH: none noted.			1						1	Back pain; Borrelia burgdorferi serology negative; CSF cell count normal; CSF glucose normal; CSF protein normal; CSF white blood cell count negative; Chest X-ray normal; Culture; Emotional distress; Gram stain negative; Injection site erythema; Injection site induration; Irritability; Metabolic function test; Myalgia; Neutrophil percentage increased; Urine analysis normal; Virus culture; White blood cell count normal	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B1168A~UNK~IM~RL~DTAP + IPV (KINRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500677P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~MERCK & CO. INC.~0640Y~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0800Y~2~SC~LL~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0357063	09/12/2009	VA	39.0	39		F	09/12/2009	Numbness and tingling in arm where injection given, dizziness, lightheadedness.										09/12/2009	09/12/2009	0		UNK	PVT						1						1	Dizziness; Injection site anaesthesia; Paraesthesia	FLU3~SANOFI PASTEUR~U3209AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357065	09/12/2009	SC	73.0	72		F	09/12/2009	Patient was given vaccination at about 1:55PM with no problem. Husband told me following morning around 5:00am she experienced nausea, feet swelling, tongue swelling, pain in sternum and BP of 90/60. Patient went to the ER and received Prednisone 20mg - 2 tabs twice daily for four days.				Y					Y	09/11/2009	09/12/2009	1		UNK	UNK	non listed	no	no, however patient's husband mentions the next day she has a soybean allergy.	na~ ()~NULL~~In Patient|na~ ()~NULL~~In Sibling1|na~ ()~NULL~~In Sibling2		1						1	Blood pressure decreased; Chest pain; Nausea; Oedema peripheral; Swollen tongue	FLU3~SANOFI PASTEUR~U3192AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357066	09/12/2009	FL	19.0	19		M	09/12/2009	pt described numbness in arm where he received vaccine from shoulder to elbow about 20 minutes after receiving vaccine									U	09/12/2009	09/12/2009	0	n/a	UNK	UNK	prilosec prn	none	none			1						1	Injection site anaesthesia	FLU3~SANOFI PASTEUR~U3204AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357067	09/12/2009	CA	85.0	85		F	09/12/2009	Left arm red, swollen, and hot from top of shoulder to elbow extending halfway around the arm.  Pt is also complaining of a slight wheeze approximately 24 hours after the injection.  Diphenhydramine oral was ordered and given.  Oxygen was placed intranasally.									Y	09/11/2009	09/12/2009	1	chemistry/serology demonstrate elevated amylase and lipase prior to injection; SGOT and SGPT elevated slightly day after injection	PVT	PVT	digoxin, diltiazem,morphine, ondansetron	acute pancreatitis	no known allergies, dementia (age related)			1						1	Alanine aminotransferase increased; Aspartate aminotransferase increased; Erythema; Oedema peripheral; Skin warm; Wheezing	FLU3~CSL LIMITED~05549111a~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~05084~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357069	09/13/2009	GA	3.0	3		F	09/13/2009	MY Daughter received the MIST in the nose for seasonal influenza. Live, Intranasal Influenza Vaccine immediate clear runny nose, fever of 102 within 24 hours, dry cough within 24 hours.  fever lasted for less than 48 hours. runny nose continued with a cough for about one week.									Y	08/17/2009	08/17/2009	0	None. Called Dr. Office regarding fever, as is listed on the CDC form and was told that it couldn't be from the nasal mist vaccine -	UNK	UNK	None	None	None			1						1	Cough; Immediate post-injection reaction; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~MIST~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0357070	09/13/2009	OH	42.0	42		M	09/13/2009	Got shot at 1:00 pm on thursday sept 10th 2009 at pharmacy by pharmacist. 30 minutes after shot started profuse sweating and feeling like my stomach and skin were on fire then had some trouble swallowing. 3 pm became red rashy and hived on face neck and upper chest and at 4pm begin urinating every 5 to 10 minutes and until 10 pm that evening. Started taking Benadryl at 4 pm called family physician. No response til next day from them. Called pharmacy also next day which recommended Benadryl and call doctor. Doctor advised Benadryl.  Doctor gave prescription of Atarax Sat Sept 12th due to still having flushing/hiving but has become less harsh and coming and going away. I am somewhat better today Sept 13th but still have mild symtoms but a little lightheaded feeling. Family doctor said to avoid any future flu vaccines despite being in the risk category of needing one and for your information I also regularly get flu vaccines yearly though last year (2008) it hurt from my shot location to my hand and up through my neck but cleared up within two days and I did not report that did not know it was a potential problem. This 2008 shot was also at the same pharmacy.										09/11/2009	09/11/2009	0		UNK	UNK	veraspimil 240 mg cozaar 50mg amoxycillin 500mg	ear infection week preceding	chronic asthma/high blood pressure/anxiety disorder/major depression severe/***allergic to steroids**high liver enzymes/some allergies and chemical irritant	measle like rash~Measles + Mumps + Rubella (no brand name)~~0.00~Patient		1						1	Abdominal discomfort; Burning sensation; Dizziness; Dysphagia; Flushing; Hyperhidrosis; Injection site pain; Pollakiuria; Rash erythematous; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0357072	09/13/2009	NY	39.0	39		F	09/13/2009	Began to feel dizzy and light headed.  Went to bathroom and for almost 10 minutes my body went into a full sweat.  I was soaking wet feeling either like I was going to faint or get sick.  I did neither.  After 10 minutes I was able to get up and dry myself off.  I then got a bottle of water and lied down for an hour.  I felt better after that.									Y	09/13/2009	09/13/2009	0		PUB	PVT	none	none	none			1						1	Dizziness; Hyperhidrosis; Malaise	FLU3~SANOFI PASTEUR~U3259EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357079	09/13/2009	IL	33.0	33		M	09/12/2009	Patient reported diaphoresis, tachycardia, and tingling bilaterally in arms about 5 minutes after vaccine administration.  We monitored B.P. and within 30 minutes the patient stabilized and felt fine.									Y	09/12/2009	09/12/2009	0	Blood pressu 106/60 mmHG;  Pulse 65 BPM	OTH	PVT		None				1						1	Blood pressure normal; Hyperhidrosis; Paraesthesia; Tachycardia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97859P2~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357080	09/13/2009	GA	9.0	9		F		9/13/09 - 3PM - Patient received inactivated a 0.5 ml FLUZONE in L arm right after that Pt c/o of swelling and redness. Pt complaint of arm being heavy. Vital signs Temp 98.8, Pulse 110, Rt - 20, B/P O2 Sat - 92% neuro exam(-). Pt discharged after with father as NAD.									Y	09/13/2009	09/13/2009	0	None	OTH	PVT		None	allergic to fur; apples -			1						1	Body temperature increased; Erythema; Heart rate increased; Immediate post-injection reaction; Oedema peripheral; Oxygen saturation decreased; Sensation of heaviness	FLU3~SANOFI PASTEUR~U3199AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357086	09/13/2009	AL	56.0	56		F	09/13/2009	Day following immunization, patient's sister reported pain, mass, and erythema at site of injection.  That evening symptoms spreading and pt went to E.R.  Given PREDNISONE and  culture taken.  Confirmed with patient 9-13-09.				Y					U	09/11/2009	09/12/2009	1	Awaiting results	OTH	PVT						1						1	Culture; Injection site erythema; Injection site mass; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357113	09/13/2009	CA	54.0	54		F	09/13/2009	Patient received PNEUMOVAX on 9/11/09 developed swollen lymphnodes on her right arm (injection site), arm severely hurt, fever of 100.7 degrees F, and chills.				Y					U	09/11/2009	09/12/2009	1		UNK	PVT	Unknown		Allergy to penicillin and DIFLUCAN			1						1	Chills; Injection site lymphadenopathy; Injection site pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P2~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0867X~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0357121	09/14/2009					F	09/14/2009	We received the following information from the literature article on 02 SEP 2009: A female adult patient had suffered from exacerbation of ulcerative colitis following an influenza vaccination (manufacturer, batch no. or vaccination date not reported). The woman had been managed with 6-MP, sulfasalazine, and intermittent steroids and she had been in remission without steroids for 9 months when she was vaccinated with another influenza vaccine. The night after that vaccination she developed abdominal pain and bloody diarrhea (please refer to case MA2009-2379). (Requests were sent on 03 SEP 2009, 09 SEP 2009 and 17 NOV 2009, no follow-up information received.)									Y					OTH	OTH	No other medications	Colitis Ulcerative			MA20092378	1						1	Abdominal pain; Colitis ulcerative; Condition aggravated; Diarrhoea haemorrhagic	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0357122	09/14/2009					F	09/14/2009	We received the following information from a literature article on 02 SEP 2009: A female adult patient with ulcerative colitis had been managed with 6-MP, sulfasalazine, and intermittent steroids and she had been in remission without steroids for 9 months. After 9 months on 6-MP and while in remission, she received a subcutaneous injection of influenza vaccine (manufacturer and batch no. unknown) and that night she developed abdominal pain and bloody diarrhea. On examination she had very active ulcerative colitis with friability, ulceration, and exudate. She also had recurrence of bilateral uveitis. She was hospitalised and treated with intravenous adrenocorticotropin hormone (ACTH) followed by tapering doses of prednisone. Again she improved, but incompletely. The 6-MP was increased to 150 mg/day and she required larger doses of steroids, becoming very cushingoid. One year after the diagnosis of ulcerative colitis was established the chronicity of her illness and the complications of steroids warranted surgical intervention. She underwent total colectomy with establishment of an ileoanal pouch anastomosis. Pathology confirmed the presence of a universal ulcerative colitis and there was no involvement of the terminal ileum. After 1 year with intermittent pouchitis, the pouch and the ileum looked normal. The patient suffered from earlier exacerbation of ulcerative colitis after a previous influenza vaccination (please refer to case MA2009-2378). (Requests were sent on 03 SEP 2009, 09 SEP 2009 and 17 NOV 2009, no follow-up information received.)					Y			Y	N					OTH	OTH	No other medications	Unknown	Ulcerative colitis		MA20092379	1						1	Abdominal pain; Colectomy total; Condition aggravated; Cushingoid; Diarrhoea haemorrhagic; Pelvic pouch procedure; Pouchitis; Surgery; Uveitis	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation,Disabling	Influenza
0357143	09/14/2009	CA	23.0	23		F	09/10/2009	Patient was injected with Fluvirin instead of Afluria. Patient is Pregnant.									U	09/03/2009				OTH	PVT	prenatal					1						1	Drug exposure during pregnancy; Wrong drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357144	09/14/2009	AZ	61.0	61		F	09/08/2009	Noted pain (Lt) lower back. While driving home had received flu vaccine prior to pain also noted staring in abd. and numbness lower (Lt) abd and left side vaginal area.									N	08/31/2009	08/31/2009	0		PUB	UNK						1						1	Abdominal distension; Abdominal pain; Back pain; Hypoaesthesia	FLU3~CSL LIMITED~02149211a~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357145	09/14/2009	AZ	49.0	49		F	09/02/2009	Localized warmth and pruritus at injection site (right deltoid).				Y					Y	08/31/2009	09/01/2009	1		PUB	PUB		None	Multiple Rx allergies	None~ ()~~0.00~Patient|None~ ()~~0.00~Sibling		1						1	Injection site pruritus; Injection site warmth	FLU3~CSL LIMITED~02149211A~1~UN~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0357146	09/14/2009	AZ				F	09/08/2009	Was given Influenza on 8/31/009, stated left arm from shoulder to elbow painful for a few days. States had small reddened area at site of injection none noted today.									Y	08/31/2009	08/31/2009	0		PUB	UNK						1						1	Injection site erythema; Injection site pain	FLU3~CSL LIMITED~06149211A~UNK~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357147	09/14/2009	AZ	30.0	30		M	08/27/2009	Flu vaccine given (Lt) upper arm , noted pain and burning sensation down arm and joint pain wrist, (Lt) thumb and elbow. Tender to touch unable to exercise. Also noted tenderness (Lt) side of body to mid back									Y	08/24/2009	08/25/2009	1		PUB	UNK		None				1						1	Activities of daily living impaired; Arthralgia; Burning sensation; Injection site pain; Tenderness	FLU3~CSL LIMITED~02149211A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357149	09/14/2009	PA	4.0	4		M	09/09/2009	After shots, patient returned within a few minutes with hives on face, and small papules and swelling of cheeks and lips.  No swelling of tongue.  Occasional cough.  Lungs clear.  Given BENADRYL and resolved.									Y	09/09/2009	09/09/2009	0	None	PVT	PVT	None	None	None			1						1	Cough; Lip swelling; Rash papular; Swelling face; Urticaria	DTAP~SANOFI PASTEUR~C3157AA~5~IM~LA~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500695P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~D0304~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0357184	09/14/2009	VA	17.0	17		F	09/14/2009	LEFT SHOULDER AND DELTOID 3 IRREGULAR TENDER FROM MIDDLE RED. LOCAL REACTION TO VACCINE									U	09/11/2009	09/14/2009	3	NONE	PVT	PVT	BENADRYL;ALLEGRA	SEASONAL ALLERGIES	EXERCISED INDUCED ASTHMA			1						1	Erythema; Local reaction; Tenderness	FLU3~SANOFI PASTEUR~U3204AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0982X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357188	09/14/2009	SC	55.0	55		F	09/14/2009	Patient contacted the health dept this morning. Reports onset of symptoms 9/9/09 with swelling and redness at injection site. Warm to touch. Has been taking Tylenol. Has a lump the size of an egg at injection site and arm still red and swollen.										09/08/2009	09/09/2009	1		UNK	UNK					SC0922	1						1	Injection site erythema; Injection site mass; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA259AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1435X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~UF485BA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0357194	09/14/2009	NC	56.0	56		F	09/14/2009	Patient felt dizzy 30 minutes after the chot was given.  She sat for 20 minutes then left.									Y	09/14/2009	09/14/2009	0		UNK	UNK		allergy congestion	allergies seasonal			1						1	Dizziness	FLU3~SANOFI PASTEUR~U3209AA~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357196	09/14/2009	AZ	73.0	73		F	09/14/2009	Patient's husband described: within 2 hrs developed itching, burning of skin at site of vaccine. Continued with redness, burning for 5 days. Symptoms have resolved									Y	09/08/2009	09/08/2009	0	none, she did not seek medical care following the vaccine	UNK	PVT		none	no known allergies, hx of hiatal hernia			1						1	Injection site erythema; Injection site pain; Injection site pruritus	FLU3~SANOFI PASTEUR~U3201AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357197	09/14/2009	NJ	4.0	4		F	09/14/2009	Patient began complaining of sore throat from the Flu Mist, immediately. Saturday and Sunday had loss of appetite and abdominal pain. Monday began running fever of over 101 degrees.									U	09/11/2009	09/12/2009	1		UNK	UNK	none	none	none			1						1	Abdominal pain; Decreased appetite; Immediate post-injection reaction; Oropharyngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0357198	09/14/2009	NJ	2.0	2	.7	M	09/14/2009	Began running fever, almost immediately. Continued running fever of 100.6 - 101.3 for next two days.									Y	09/11/2009	09/11/2009	0		PVT	PVT	Trileptal and Lamectal, twice, daily.	Complex Partial Epilepsy - no symptoms at time of FluMist.	Complex Partial Epilepsy			1						1	Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0357199	09/14/2009	NC	4.0	4		M	09/14/2009	C/O BURNING AND REDNESS LEFT THIGH, GOT IMMUNIZATIONS THURS 9-10-09.FRIDAY CHILD LIMPING AND LEG LOOKED PURPLE AND VERY WARM. IMPROVED BY TIME SEEN SAT, ERYTHEMATOUS COVERING ANTERIOR PORTION OF THIGH. PT EXAMINED IN ER 9-12-09.				Y					Y	09/10/2009	09/11/2009	1	NONE	PVT	PUB	ALBUTEROL PRN	NONE	REACTIVE AIRWAY			1						1	Gait disturbance; Injection site discolouration; Injection site erythema; Injection site pain; Injection site warmth; Rash erythematous	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B115AA~1~IM~LL~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~U3208AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0551Y~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0807Y~2~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0357208	09/14/2009	NM	51.0	51		F	09/14/2009	extreme achiness at site and into joint area										09/10/2009	09/11/2009	1		PVT	UNK						1						1	Arthralgia; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97845P2~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357209	09/14/2009	MD	50.0	50		F	09/14/2009	Client reported 4 X 11/2 area of induration that started near the injection site and spread distal the site.  Reported area was red.  Denied itching.  Took Hydrochloride 10mg tables.  Area was observed by Medical Director and he recommended Benadryl per client.									Y	09/09/2009	09/10/2009	1		UNK	UNK	Lyrica 75mg HS and Flexeril 10mg HS	Denied illness	Cervical Herniated Disk, Scleroderma(no treatment), Allergic to PCN			1						1	Injection site erythema; Injection site induration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA275AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0357211	09/14/2009	TN	24.0	24		F	09/14/2009	Enlarged, grape-sized nodule above collarbone. Painful and swollen.									Y	09/08/2009	09/09/2009	1		PVT	PVT	None	None	None			1						1	Nodule; Pain; Swelling	FLU3~SANOFI PASTEUR~U3178AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357212	09/14/2009	NV	1.54	1	.5	F	09/14/2009	High Fever (104 degrees), dizziness, loss of appetite, moderate lethargy.  Fever developed within 6 hours of vaccinations.  Fever and symptoms did not abate until 78 hours after the vaccination.  Treatment regimen was 5ml Motrin/Tylenol every 5 hours, tepid baths to keep fever under control.									Y	09/08/2009	09/08/2009	0		UNK	UNK	None	None	None	none~ ()~~0.00~Patient		1						1	Decreased appetite; Dizziness; Lethargy; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~2~IM~RL~HEP A (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~4~IM~RL~HIB (NO BRAND NAME)~1	USA		Influenza
0357213	09/14/2009	NE	6.0	6		M	09/14/2009	48 hours after nasal flu mist vaccination-became ill with severe headache, fever of 102.5 under armpit and continued for 4 days (missed 4 days of school)-even after fever free,severe headache continued for 2 additional days.  Last year, same occurence (did not report last year) but much more severe with uncontrolled 105 temp, severe lethargy and headache and missed 5 days of school-nearly took to ER but out of town and uncomfortable with medical care there									Y	08/29/2009	08/31/2009	2	none	PVT	UNK	None	NO	None	described above~Influenza (Seasonal) (FluMist)~UN~6.10~In Patient		1						1	Activities of daily living impaired; Headache; Lethargy; Malaise; Pyrexia; Vaccine positive rechallenge	FLUN3~MEDIMMUNE VACCINES, INC.~500681P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0357217	09/14/2009	AZ	8.0	8		F	09/14/2009	Daughter vomitted 4 hours after receiving influenza vaccination									Y	09/14/2009	09/14/2009	0	None	PUB	PVT	None	Vomit	Asthema			1						1	Vomiting	FLU3~SANOFI PASTEUR~~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357223	09/14/2009	MO	19.0	19		M	09/06/2009	He got PNEUMOVAX vaccine (SC) on his left upper arm. After 2-3 days, mom called here and told he got swelling (L) arm and diagnosed with cellulitis.									U	08/30/2009			Not known	PVT	PVT	None	No	Common variable immune deficiency			1						1	Injection site cellulitis; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA261AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1435X~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357224	09/14/2009	NY	35.0	35		F	09/14/2009	Itchy all over, feels warm all over Benadryl 20 mg PO @ 9:45 self administered.									Y	09/14/2009	09/14/2009	0		OTH	PVT	Albuterol; Singulair	None	Asthma			1						1	Pruritus generalised; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960301P~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357225	09/14/2009	NY	50.0	50		F	09/14/2009	Throat closing - itching, hives - Lot# 092040D  exp02/2011 Westward epinephrine 5.3 cc SC @ 10:30 AM (R) forearm- 11:15 AM spoke to Doctor's office  - to see Pt @ 1:45 PM									Y	09/14/2009	09/14/2009	0		OTH	PVT	LIPITOR; Folic acid	None	Aspirin; ADVIL allergies			1						1	Pruritus; Throat tightness; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960301P~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357228	09/14/2009	PA	16.0	16		F	09/10/2009	Received flu shot and Hep A.  3 minutes later standing at check out counter, fell backwards onto floor.  Hit back of head on ground.  Some twitching for 5 secs.  Regained consciousness.  Took water.  Sat up after 5 minutes walked out after 15 mins.				Y					Y	09/09/2009	09/09/2009	0	That evening more HA + confusion.  To ER.  Head CT normal.  Labs normal.  Discharged with concussion diagnosis.	PVT	PVT	No	No	Peanut allergy	dizzy~HPV (no brand name)~2~0.00~Patient		1						1	Computerised tomogram normal; Concussion; Confusional state; Fall; Head injury; Headache; Laboratory test normal; Loss of consciousness; Muscle twitching	FLU3~SANOFI PASTEUR~U3205CA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0604Y~2~UN~RA~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0357229	09/14/2009	MA	12.0	12		M	09/21/2009	Urticarial rash all over body.									U	09/09/2009	09/10/2009	1		PVT	UNK		None	None			1						1	Rash generalised; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500675P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U2906AA~2~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0357239	09/14/2009	OH	19.0			F	09/14/2009	Several minutes after vaccine patients arms and legs went stiff and patient passed out. Patient recovered shortly after.									Y	09/14/2009	09/14/2009	0	BP 123/96, 118/92	OTH	PVT			No known allergies/conditions			1						1	Blood pressure decreased; Loss of consciousness; Musculoskeletal stiffness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357240	09/14/2009	OH	73.0	73		F	09/09/2009	4 hours after immunization, left deltoid red, hard and egg shaped lump. Told pt to ice and use APAP call if worse. Patient went to ER next day - Dr. said possible cellulitis (WBC count normal). Dr. gave KEFLEX and patient's arm normal next day.				Y					Y	09/03/2009				OTH	PVT						1						1	Erythema; Induration; Mass; White blood cell count normal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~06274~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~960319P~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0357242	09/14/2009	NM	26.0	26		F	09/14/2009	-Redness, swelling at injection site of both vaccines PNEUMOVAX > then FLUVIRIN.									U	09/12/2009	09/12/2009	0		OTH	PVT	None	None	None			1						1	Injection site erythema; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~978401~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~00374~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357243	09/14/2009	NM	63.0	63		F	09/14/2009	Indigestion, 20 minutes.									Y	09/14/2009	09/14/2009	0		OTH	UNK						1						1	Dyspepsia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA265AA~UNK~IM~AR~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0504Y~UNK~IM~AR~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357244	09/14/2009	CO	0.5	0	.5	M	09/14/2009	Episode of apparent limpness, lethargy occurring during car ride home after vaccinations, lasting several minutes. Normal exam when subsequently reassessed, no treatment.									Y	09/10/2009	09/10/2009	0		PVT	PVT	None	None	None			1						1	Hypotonia; Lethargy	DTAPIPVHIB~SANOFI PASTEUR~C3396AA~UNK~IM~LL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~UT3171DA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~D75884~3~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~01764~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0357245	09/14/2009	IA	27.0	27		F	09/10/2009	Received flu shot on 9/1/09 by 1200 on 9/2/09 right deltoid developed a silver dollar welt it was red, hard and painful. She took Benadryl, Tylenol and heat until 9/6/09 went it was gone. On 9/3/09 she reported it to Hospital.									Y	09/01/2009	09/02/2009	1	None	PVT	PVT	Ambien; Nortriptyline; Zoloft; Topamax; Birth control - 10mg	None	Migraine		IA090021	1						1	Erythema; Induration; Pain in extremity; Urticaria	FLU3~CSL LIMITED~01849211A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357246	09/14/2009	IA	24.0	24		F	09/10/2009	By evening a nickel size welt appeared at injection site.  It was red, swollen, and hard.  Plan: Watch.  Gone:  By Friday Sept. 4, 2009.									Y	09/01/2009	09/01/2009	0	None	PVT	PVT	Birth Control - YAZ	None	Seasonal - allergies - PCN; Sulfa.		IA090020	1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site urticaria	FLU3~CSL LIMITED~018449211A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357247	09/14/2009	IA	26.0	26		F	09/10/2009	Two Quarter size welts on left deltoid. Welt is red, hard. Treatment: Watched until it was gone Friday 9/4/09.									Y	09/01/2009	09/02/2009	1	none	PVT	PVT	none	no	none		IA090019	1						1	Erythema; Induration; Urticaria	FLU3~CSL LIMITED~018449211A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357248	09/14/2009	IA	26.0	26		F	09/10/2009	1/2 dollar size welt on (L) deltoid. Welt was red, tender and hard. Treatment: watched until gone - Gone by Friday 9/4/09.									Y	09/01/2009	09/02/2009	1	None	PVT	PVT	LEXAPRO	None	None			1						1	Erythema; Induration; Tenderness; Urticaria	FLU3~CSL LIMITED~018449211A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357250	09/14/2009	ID	41.0	41		F	09/10/2009	Right deltoid burned on injection and keep burning. It became hard to move by the next morning it was swollen and red. Treatment- watch applied heat. Gone by Sunday Sept 6 2009.									Y	09/01/2009	09/01/2009	0	None	PVT	PVT	Vicodin; Synthroid; Ambien	None	Allergy- Erythromycin hypothyroid			1						1	Injection site erythema; Injection site pain; Injection site swelling; Movement disorder	FLU3~CSL LIMITED~018449211A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357251	09/14/2009	IA	43.0	43		F	09/10/2009	Over the course of 2 days developed redness and swelling on left arm that itched and was blotchy. On 9/3/09 went to Clinic to see physician. She stated it was starting to spread dawn bicep. Plan-Prednisone X 11 days and loratadine. Follow up in 2 wks.				Y					Y	09/01/2009	09/02/2009	1	None	PVT	PVT	LAMICTAL; Hormone replacement	None	Seizures - 9 yrs			1						1	Erythema; Oedema peripheral; Pruritus; Rash macular	FLU3~CSL LIMITED~018449211A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0357252	09/14/2009	IA	34.0	34		F	09/10/2009	Developed redness and started to itch on 9/3/09. Continued to get worse want to Dr. on pt had hives down left arm. Plan-CLARITIN x 30 days. PREDNISONE taper 11 days. 3 week physician following.				Y					Y	09/02/2009	09/03/2009	1	None	PVT	PVT	ADVAIR	Ear Infection -  Z pack	Asthma			1						1	Erythema; Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~018449211A~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0357253	09/14/2009	IA	41.0	41		F	09/10/2009	Received the flu shot on 9/2/09 at 08AM.  By 21:00 on 9/2/09 she noticed hives on left arm and bilateral thighs.  The hives were red, raised, and white in center.  She reported them on 9/3/09 when she went to campus clinic.  Plan - CLARITIN X 1 month, and PREDNISONE x 11 days.  Follow up 2 weeks.				Y					Y	09/02/2009	09/02/2009	0	None	PVT	PVT	IMITREX; YAZ; CEIEXA.	None	Hay fever; Migraines.			1						1	Erythema; Swelling; Urticaria	FLU3~CSL LIMITED~01844211A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0357254	09/14/2009	IA	49.0	49		F	09/10/2009	On 9/3/09 in the evening face and ears began to itch, overnight the itching got worse. Nothing seen. Pt takes CLARITIN for seasonal allergies, so took some for the itching. Which improved. It was better by Sept. 5, 2009.									Y	09/02/2009	09/03/2009	1	None	PVT	PVT	None	None	Allergies - environmental			1						1	Pruritus	FLU3~CSL LIMITED~018449211A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357255	09/14/2009	MI	62.0	62		M	09/14/2009	Patient said shortly after vaccination had following sx: 1. Blurry vision, 2. Numbing forearm, 3. Numbing arm and leg (left) vision got better shortly after forearm also, leg and arm (left) was also getting better. Patient left and said would call if needed.									Y	09/14/2009	09/14/2009	0		OTH	PVT	PROPECIA					1						1	Hypoaesthesia; Immediate post-injection reaction; Vision blurred	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841PL~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357258	09/14/2009	MI	64.0	64		F		Was not feeling well prior to shot (nauseated). 2hrs after shot, vomiting and sweating a drop in temp. (96.1F) continued for 3-4 days. Patient feels this may be a coincidence. PCP Doctor would like reported as well.									Y	09/08/2009	09/08/2009	0	None	OTH	PVT	Requip; Zestoretic; Tramadol, Prednisone; Estradiol; Klonopin	Mild Nausea	Hypertension, prior GI bleed (unspecified) anxiety, allergy to Levaquin, Penicillin, Bactrim			1						1	Body temperature decreased; Hyperhidrosis; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U3171AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357260	09/14/2009	NC	44.0	44		F	09/14/2009	Pt reported on 09-12-09 at 9:30 AM noted raised, warm area on (L) arm where was vaccine given. Stated as day progressed noted itching under skin, increase whole body achy, felt feverish. Large raised, reddish purplish area noted near injection site 16 mm -> 12 mm increase raise 0.10 mm ->.20 mm  - took ZYRTEC that AM - No other treatment.									Y	09/11/2009	09/12/2009	1		OTH	PVT	ZYRTEC; Vita	None reported	ULTRAM; FLOXIN; BACTRIM			1						1	Injection site swelling; Injection site warmth; Pain; Pruritus; Pyrexia; Skin discolouration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA262AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0357261	09/14/2009	IN	65.0	65		F	09/14/2009	4 hours post vaccination 5 episodes of dizziness followed by nausea lasting about 2 minutes. Patient noticed reaction on 9-4-09. These episodes continued 9-7-09. Frequency change to 2 times a day with only mild dizziness w/ nausea.									N	09/04/2009	09/04/2009	0	No tests were performed (patient did not have recent blood pressure med changes)	OTH	OTH	TOPROL XL 50mg once po qD; COZAAR 50mg once po qD	None	Allergic to dextrose; Hypertension			1						1	Dizziness; Nausea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357267	09/14/2009	IL	69.0	69		F	09/14/2009	Redness, swelling, not itching, very sore, ripple around red area.									Y	09/11/2009	09/11/2009	0		OTH	PUB	None reported		ADVIL			1						1	Erythema; Pain; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840PI~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357268	09/14/2009	HI	49.0	49		F	09/09/2009	Slight sore throat.  Aches & pains in joints whole body.  Started with symptoms with in 1 1/2 to 2 hours after vaccine.  Took TYLENOL (symptoms lasted 3 days.				Y					Y	09/02/2009	09/02/2009	0	None	PVT	OTH	HCT2; LOPRESSOR.	None	Allergy to PCN			1						1	Arthralgia; Oropharyngeal pain; Pain	FLU3~SANOFI PASTEUR~U3173BA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357269	09/14/2009	HI	59.0	59		F	09/05/2009	Received vaccine @ 08:40, @ 10:00 became dizzy with elevated blood pressure.				Y					Y	09/04/2009	09/04/2009	0	None	PVT	UNK		None	None			1						1	Blood pressure increased; Dizziness	FLU3~SANOFI PASTEUR~U3173BA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357270	09/14/2009	WI	19.0	19		F	09/12/2009	I was driving home from a friends house and lost sight in my right eye.  It just went black.  This was about 4 or 5 hours after I got my flu shot & my sight was gone for about an hour & a half - 2 hours.  Prior to this (1/2 hr) patient had blurry vision and was out of it.									Y	09/11/2009	09/11/2009	0		PUB	PVT	None	None	None			1						1	Blindness unilateral; Feeling abnormal; Vision blurred	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357273	09/14/2009	NY	23.0			M	09/14/2009	Pt in few hour experienced numbness of the entire arm where he received the vaccine.  The numbness went away in few hours.									Y					OTH	PVT	None	None				1						1	Hypoaesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357219	09/15/2009	IA	62.0	62		F	09/15/2009	About 3 hours after vaccine was given I began to vomit intractably for 2 1/2 hours.  Also had mod abdominal pain at the same time.  I have continued to have abdominal pain at intervals for the past 5 days following vaccine.  No treatment has been done at this point.									Y	09/08/2009	09/08/2009	0		PVT	UNK	Actonel, Evista, Levothyroxine, Calcium, Vit D, Omeprazole.	no	none			1						1	Abdominal pain; Vomiting	FLUX~UNKNOWN MANUFACTURER~not known~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0357278	09/15/2009	OH	35.0	35		F	09/15/2009	Pt call 9AM rash developed/itching on both arms from arm pit to elbow, interior arm started 7:30 A advised patient to notify MD and take antihistamine unless MD consults otherwise. No other changes made.									U	09/14/2009	09/15/2009	1		OTH	OTH	unknown	none	unknown			1						1	Pruritus; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848P1C~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357279	09/15/2009	OH	11.0	11		M	09/15/2009	Administered FLULAVAL 0.5ml to him by im (FLULAVAL is for age equal to or greater than 18).									Y	09/09/2009				PVT	PVT		None	None			1						1	Inappropriate schedule of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFUA261AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0357285	09/15/2009	VA	8.0	8		M	09/04/2009	Flu vaccine licensed for 18 yrs and up was given to an 8 year old. No signs of symptoms noted.									Y	09/04/2009	09/04/2009	0		PUB	UNK		none	Asthma			1						1	Inappropriate schedule of drug administration	FLU3~CSL LIMITED~01849211A~1~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357286	09/15/2009	WA	62.0	62		F	09/01/2009	Chills, fevers, sweating, severe pain R arm (4x 7) w/ swelling, redness, pt. couldn't use R arm, systemic deep muscle pain, rapid temperature shifts, sx resolved by 1200pm 8/27/09, lost appetite.									Y	08/25/2009	08/26/2009	1		OTH	PUB		None				1						1	Body temperature fluctuation; Chills; Decreased appetite; Erythema; Hyperhidrosis; Injected limb mobility decreased; Myalgia; Oedema peripheral; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~02249111A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1162X~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357288	09/15/2009	ID	66.0	66		F	09/09/2009	No adverse events.										09/09/2009				PVT	UNK		Thumb laceration	None			1						1	No adverse event	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AF114259AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|TDAP~SANOFI PASTEUR~C3351AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0357290	09/15/2009	PA	18.0	18		F	09/09/2009	The student received the flu shot R deltoid, became pale, emesis x1, no loss of consciousness. Able to ambulate.									Y	09/09/2009	09/09/2009	0		OTH	PVT	None					1						1	Pallor; Vomiting	FLU3~SANOFI PASTEUR~U3195AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357291	09/15/2009	PA	21.0	21		F	09/09/2009	The student became lightheaded about 5 minutes post injection.  No acute breathing distress or hives @ 1040.									Y	09/09/2009	09/09/2009	0		OTH	OTH	None	Denies	None			1						1	Dizziness	FLU3~SANOFI PASTEUR~U3195AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357292	09/15/2009	PA	18.0	18		F	09/09/2009	The student received a flu vaccination walked back to chair in the waiting area and fainted in her chair.  Immediately arrousable with spirits of ammonia.  Able to ambulate.									Y	09/09/2009	09/09/2009	0		OTH	OTH	None	Denies	None			1						1	Syncope	FLU3~SANOFI PASTEUR~U3195AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357294	09/15/2009	MN	56.0	56		F	09/09/2009	9/4/09, low grade fever, vomiting, nausea flu shot given 9/2/09.										09/02/2009	09/03/2009	1	none	PVT	PVT	Hydrochlorothiazide; Atenolol; Lorazepam; ZOLOFT; WELLBUTRIN; cyclobenzaprine	none	hyperlipidemia			1						1	Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U3195AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357295	09/15/2009	PA	77.0	77		F	09/10/2009	Patient came back to our pharmacy 2 days after administering of flu vaccine and complaint Tuesday her arm was sore. I examined her arm and noted that elbow area was swollen, showed bruising and felt hot.									U	09/08/2009	09/10/2009	2		OTH	OTH						1						1	Contusion; Joint swelling; Pain in extremity; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357297	09/15/2009	VA	6.0	6		M	09/11/2009	Pt received FLUMIST at about 14:25.  No history of egg allergy.  Pt then went to soccer practice.  No Hx of trauma per parent.  At 1930 pt's mom called to say his nose was swollen and he c/o pain below collar bone.  Unable to breath through nose.  No other difficulty breathing, no rash.  Better in AM - after 1 dose oral BENADRYL.									Y	09/10/2009	09/10/2009	0	All per parent report	PVT	PVT	None	None	Fish allergy, seasonal allergies.			1						1	Musculoskeletal pain; Nasal congestion; Swelling	FLUN3~MEDIMMUNE VACCINES, INC.~500675P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0357298	09/15/2009	DE	57.0	57		F	09/09/2009	Itching in area of injection down to elbow on left arm with hives/rash upset stomach 9/8/09.									U	08/31/2009	09/02/2009	2		OTH	PVT	ALPRAZOLAM; METFORMINR; CRESTOR; CARVETILOL; MTX; RANITIDINE; SINGULE; FLUTIRASONE NASAL; SINGULAIR CPN; PRAVACID; CYMB; SPLRIL.	No	None			1						1	Abdominal discomfort; Injection site pruritus; Injection site rash; Injection site urticaria; Rash; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357309	09/15/2009	PA				F	09/03/2009	Eyes red, swollen throat and face swollen busted, lips, tongue swollen.				Y					Y					OTH	UNK		Cough				1						1	Lip swelling; Ocular hyperaemia; Pharyngeal oedema; Swelling face; Swollen tongue	FLU3~SANOFI PASTEUR~43171AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357311	09/15/2009	CT	13.0	13		M	09/14/2009	Administered GSK to < 18 yr old.									Y	09/14/2009			None	PUB	PVT		None	None			1						1	Inappropriate schedule of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA281AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0357312	09/15/2009	CT	14.0	14		M	09/14/2009	Administered GSK to < 18 yr old c/o stomach upset, vomiting 7 hours after vaccine no fever.									Y	09/14/2009	09/14/2009	0	None	PUB	PVT		None	None			1						1	Abdominal pain upper; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA281AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0357316	09/15/2009	MD	43.0	43		F	09/10/2009	7.0 x 5.0 cm wheal. 25mg BENADRYL given & ice applied.									Y	09/10/2009	09/10/2009	0		PVT	PVT			Asthma			1						1	Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA256AA~UNK~ID~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1441X~1~ID~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357325	09/15/2009	AL	87.0	87		F	09/15/2009	Knot under skin at site of injection - (patient remained on premises for 20 min.)  Called patient @ 1:15 PM & she said her arm was fine and knot had gone away.									Y	09/15/2009	09/15/2009	0		UNK	PUB		None				1						1	Injection site mass	FLU3~SANOFI PASTEUR~U3176CA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357326	09/15/2009	MA	60.0	60		F	09/14/2009	Once given flu shot, patient immediately explained a soreness in neck & swelling in throat, swollen glands. Asked pt to take slow deep breaths, she did so without difficulty. Patient was given 2 teaspoonfuls of BENADRYL per her request. Patient's doctor was called & told us to send her to ER, 911 was called & patient was taken to ER.				Y					U	09/11/2009	09/11/2009	0		OTH	UNK						1						1	Immediate post-injection reaction; Lymphadenopathy; Neck pain; Pharyngeal oedema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357327	09/15/2009	MA	80.0	80		F	09/11/2009	Redness approx. 4 inches in diam. on Lt. upper arm. Sl. swelling.									Y	09/09/2009	09/11/2009	2		UNK	PUB	DEPAKOTE; Phenobarb; Vit C; BP med	None	Seizure disorder			1						1	Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~U3188AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357328	09/15/2009	DE	78.0	78		F	09/03/2009	Swelling from elbow upwards, mild pain, red, itchy & puffy arm. Reaction happened the next day after the shot. Pt. was itchy & itched hard with her fingers. Reaction subsided on 9/3/09.									Y	08/28/2009				OTH	UNK	LIPITOR; Ramipril; Atenolol; Alendronate	No	No			1						1	Erythema; Oedema peripheral; Pain in extremity; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839PZ~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1296X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357331	09/15/2009	OH	14.0	14		F	09/05/2009	Swollen area around injection site. Tender, warm 10cm x 4cm.									U	09/02/2009	09/05/2009	3	None	PVT	PVT	EPI PEN PRN	None	Walnuts			1						1	Injection site pain; Injection site swelling; Injection site warmth	FLUN3~MEDIMMUNE VACCINES, INC.~500695P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U3030AA~1~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0357333	09/15/2009	KY	3.0	3		F		MCA stroke on 9/4/09. Aphasia. Hemiplegic.   11/18/09:  ED and Hospital Records and Discharge Summary received for dates of service 9/4/09 to 9/10/09.  Dx:  Left middle cerebral artery infarct, right-sided weakness, expressive aphasia.  Assessment:  On day prior to admission child bumped her head while playing at school, no LOC.  Later began having hiccups and drooling out of R side of mouth.  Difficulty speaking and unsteady gait. Developed dense R sided hemiparesis and inability to talk.  Brought to ED and admitted overnight for observation.  MRI of brain showed L MCA infarct.  Transferred to ICU.  Right sided facial weakness, decreased muscle tone, weakness on R. IV fluids provided due to numerous sedations.  Decreased appetite. Discharged to rehabilitation center for PT, OT and speech therapy.					Y	6			N	08/27/2009	09/04/2009	8	MRI; Echo; TEE; clotting labs (P).  11/18/09:  ED and Hospital Records and Discharge Summary received for dates of service 9/4/09 to 9/10/09. Labs and diagnostics:  Segs % 55 (H), Immature Gran % 1 (H), PTT 22.5 (L), HDL 30 (L), Acetaminophen < 10.0 (L), Echo. (NL), CT Brain-Neg., MRA neck and superior chest (NL). MRA Brain-large infarct developing in much of the left MCA territory. TEE Nl. echo. and saline contrast study.  ANA Neg.	PVT	PVT	None	None	None.  11/18/09:  ED and Hospital Records and Discharge Summary received for dates of service 9/4/09 to 9/10/09. PMH:  None.			1						1	Aphasia; Cerebrovascular accident; Coagulation test; Echocardiogram; Hemiplegia; Laboratory test; Nuclear magnetic resonance imaging	FLUN3~MEDIMMUNE VACCINES, INC.~500675P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0357335	09/15/2009	FL	68.0	68		F	09/06/2009	Redness, inflammation, hardening of inj. site, feverish.									Y	09/02/2009	09/03/2009	1		OTH	PVT		No				1						1	Injection site erythema; Injection site induration; Injection site inflammation; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97844P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357336	09/15/2009	NE	2.0	2	.9	F	09/09/2009	Facial swelling, nose & eyes, 12 hrs after mist.				Y					Y	09/08/2009	09/09/2009	1		PVT	PVT		None				1						1	Eye swelling; Nasal oedema; Swelling face	FLUN3~MEDIMMUNE VACCINES, INC.~500681P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0357339	09/15/2009	CO	62.0	62		F	09/04/2009	Bitter taste in mouth that happened immediately & subsided in 1/2 hr. Lightheadedness/dizziness, slightly nauseous.									Y	09/04/2009	09/04/2009	0		OTH	PVT	PREVACID; LAMICTAL	No	Grass allergy			1						1	Dizziness; Dysgeusia; Immediate post-injection reaction; Nausea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357340	09/15/2009	TX	69.0	69		F	09/08/2009	Patients arm was in pain the evening of administration and then in extreme pain to where she couldn't move it. The following day she saw PCP who diagnosed her with cellulitis and put her on oral Augmentin. (Left arm)				Y						09/01/2009	09/01/2009	0	Abnormal- Cellulitis	OTH	PUB		None				1						1	Cellulitis; Diagnostic procedure; Injected limb mobility decreased; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~1162X~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~9784182A~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0357345	09/15/2009	AL	51.0	51		F	09/03/2009	Patient feels like she has a cold coming on.  Patient said she was going to take some over the counter TYLENOL.									U	09/01/2009	09/02/2009	1		OTH	PVT		None				1						1	Nasopharyngitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357346	09/15/2009	SC	64.0	64		F	09/08/2009	Patient reported redness, swelling, hives, itching in right arm (opposite arm from vaccine administration).  Symptoms presented 3 days after vaccine & have persisted X 3 days.  Pt instructed to take oral BENADRYL & call MD.  MD called 9/8 by pharmacy Dr.									N	09/02/2009	09/05/2009	3		OTH	PVT	BONIVA					1						1	Erythema; Oedema peripheral; Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~9783982~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357347	09/15/2009	WA	57.0	57		F	09/04/2009	About 1 hour after receiving flu shot, patient's throat started swelling.  She felt sick.  About 2 hour she reported itchy throat, cough, but no shortness of breath.  Her face was itchy, eyes swelling and bloodshot.  She admitted herself to the Emergency Department, which is received treatment for about 3 hours.  She received treatment of PREDNISONE which help reduce symptoms signifigntly. Good recovery.  MD believes she may be allergic to preservatives.				Y					Y	08/31/2009	08/31/2009	0		OTH	PVT	ALCHOLOL 25 mg 10 HS	None	Hypertension			1						1	Cough; Eye swelling; Malaise; Ocular hyperaemia; Pharyngeal oedema; Pruritus; Throat irritation	FLU3~SANOFI PASTEUR~U3190AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357349	09/15/2009	GA	31.0	31		M	09/09/2009	Swollen lips in AM after - Treated w/BENADRYL.									Y	09/03/2009	09/04/2009	1		UNK	UNK	None	Sinus infection	None			1						1	Lip swelling	FLU3~SANOFI PASTEUR~U3186AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357352	09/15/2009	MD	25.0	25		F	09/15/2009	Reports pain, reddness and swelling of injections site.  Reports area of edema as 50 cent piece sized one day after injection with pain level of 6/10.  Reports intermittent numbness and tingle radiating down arm to hand starting one day after injection.  Denies treatment.  Reports 9/15/09 no edema, pain level of 1/10 and numbness and tingling that occurs @ one time daily.									U	09/11/2009	09/12/2009	1		PUB	PVT		MILD COLD				1						1	Hypoaesthesia; Injection site erythema; Injection site pain; Injection site swelling; Oedema; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA275AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0357363	09/15/2009	NJ	2.0	2	.9	M	09/15/2009	Hives post flu vaccine, pain in leg - Received benadryl and ibuprofen				Y					Y	09/11/2009	09/11/2009	0	Subsequently tested for egg allergy	PVT	PVT			pre-existing peanut allergy			1						1	Allergy test; Injection site pain; Urticaria	FLUX~SANOFI PASTEUR~U3204AA~2~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~MERCK & CO. INC.~0604y~1~IM~LL~HEP A (VAQTA)~1|HIBV~SANOFI PASTEUR~UF594AA~4~IM~LA~HIB (ACTHIB)~1	USA	Emergency room visit	Influenza
0357367	09/15/2009	CA	47.0	47		F	09/08/2009	Throat tightness, chest congestion , chest pressure.				Y					Y	09/04/2009	09/04/2009	0	No blood tests	PVT	PVT	Aspirin; Flecainide; Metoprolol		Sulfa; MACROBID			1						1	Chest discomfort; Respiratory tract congestion; Throat tightness	FLU3~SANOFI PASTEUR~U3198AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357368	09/15/2009	AZ	38.0	38		F	09/01/2009	Approximately 2 hours after receiving the vaccine the patient reported tingling down her arm.  Md told her the tingling was probably from her tensing her muscle.									U	09/01/2009	09/01/2009	0		OTH	PVT			PENICILLIN allergy			1						1	Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357374	09/15/2009	MI	7.0	7		F	09/15/2009	Concerns about dosage. Child given .5cc of FLULAVAL Adult vaccine in the office. Concerned about reactions for the patient. Concerned about adjevent and effect on children. Call to local health department. They advised parents be notified of possible elevated temp and swelling and redness at injection site. Call made to Glaxo requesting info - message left to call the office back.									Y	09/15/2009	09/15/2009	0		PVT	PVT	None	None	None			1						1	Incorrect dose administered	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA276AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0357375	09/15/2009	MI	8.0	8		M	09/15/2009	no advers events reported. Concerned about dosage. Child given .5 cc of FLULAVAL Adult vaccine in offce. Concerned about reactions for the patient, the adjevent and the effect on children. Call to local health department.They advised parents be notified of possible elevated temp, swelling and redness at injection site. Nurse manager placed a call to Glaxo for their input also. Message left - still awaiting responce									Y	09/15/2009	09/15/2009	0		PVT	PVT	none	none	none			1						1		FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA276AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0357382	09/15/2009	MI	18.0	18		F	09/08/2009	After injection patient started turning pale, then complained she didn't feel well, then passed out. Pharmacist caught her before she fell and called her name. She opened her eyes and was disoriented. Told her where was, had her lie down, monitored for 20 minutes. Her color returned and she was picked up by her boyfriend.									Y	09/08/2009	09/08/2009	0		UNK	UNK		None				1						1	Disorientation; Loss of consciousness; Malaise; Pallor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839PI~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357387	09/15/2009	AZ	40.0	40		M	09/15/2009	L arm cellulitis-Rx  Keflex 500 QiD< 10 days # 40 no refills										09/11/2009				PUB	PVT		N/A	N/A			1						1	Cellulitis	FLU3~SANOFI PASTEUR~U3194AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357388	09/15/2009	WA	38.0	38		F	09/15/2009	Patient reported CHill, panic, Racing, Heart at ~2am on 09/10/2009. Pt said she talked to Hospital ER and was told told to take Benadryl. Pt got better by the next day.									Y	09/09/2009	09/09/2009	0	N/A	OTH	PVT		None	None			1						1	Chills; Palpitations; Panic reaction	FLU3~SANOFI PASTEUR~U3185AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357389	09/15/2009	MS	48.0	48		F	09/09/2009	None stated.				Y					Y	09/04/2009	09/04/2009	0		PUB	OTH	NORVASC, HCTZ, FLEXERIL, NEUROTIN, ULTRACET, PROSIQ	Ear itching	Asthma, T BP, arthritis, depression, Acid Reflux			1						1	Unevaluable event	FLU3~CSL LIMITED~05949111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0357390	09/15/2009	FL	72.0	72		F	09/15/2009	Dizziness, heart palpitation, check BP and monitor patient till EMS arrived.				Y					U	09/15/2009	09/15/2009	0		OTH	OTH			Penicillin, Darvon, Codeine, had pace maker which pt informed later after shot.			1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97844P1~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357391	09/15/2009	GA	31.0	31		F	09/18/2009	General weakness 10 minutes after injection. Checked BP 30 minutes after injection 120/75. Pt. still felt weak/tired. Rash Began to develop 1 Hr After injection. EpiPen Refused. Ambulance Called. Pick Pt. UP 70-75 minutes after injection.				Y					U	09/08/2009	09/08/2009	0	Vital signs Normal @ ER. BP 100/87. Discharged w Oral Benadryl & Dexamethasone.	PUB	PVT	None	Anxiety/Panic Attacks	Penicillin Allergy			1						1	Asthenia; Blood pressure normal; Fatigue; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357393	09/15/2009	FL	77.0	77		F	09/04/2009	Patient returned three days after vaccination complaining of fatigue, rash on back. Presentation similar to shingles. Recommended she see doctor. Patient seen by doctor on 09/4/09 and prescribed medication for shingles. Onset appears coinadental.				Y					Y	09/01/2009	09/04/2009	3		OTH	PUB		None	None			1						1	Fatigue; Herpes zoster; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97844P1~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357395	09/15/2009	OH	81.0	81		F	09/15/2009	9/15/09 Pt. had 0.5ml of FLUVIRIN in left deltoid. Pt had swelling at injection site. Pt had no asthma symptoms. Contacted Dr and follow up with patient. Pt had no further problems 3.5 hours after injection									Y	09/15/2009	09/15/2009	0		OTH	OTH		None	None			1						1	Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357397	09/15/2009	NM	67.0	67		F	09/15/2009	Reaction @ injection site [redness] body aches, fever.									U	09/13/2009	09/13/2009	0		OTH	OTH						1						1	Injection site erythema; Injection site reaction; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~0037Y~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~97840P1~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357399	09/15/2009	MN	40.0	40		M	09/12/2009	Pt filled a VAR and said he had previously had a flu shot. Gave pt flu shot, and within about a minute pt. said  he was light headed. I told him to remain seated and went to the pharmacy to grab epi just in case. came back 30 sec after and pt was on chair with body flexed, face red , and didn't respond when I talked to him. Also his respiration sounded wheezy, so I gave him an epi-pen. Pt was alert immediately. called 911 - EMS arrived and did vitals and everything was OK. Pt went home w/wife. Pt came into pharm 4 hours later and was OK. Called pt the next evening an he was good.									Y	09/12/2009	09/12/2009	0	Per EMS - BP and pulse , normal	OTH	OTH	None	None	None			1						1	Dizziness; Erythema; Posture abnormal; Unresponsive to stimuli; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357400	09/15/2009	CA	61.0	61		F	09/11/2009	Site swollen on injected (L) arm, beginning with 2 hours. Next morning, headache, slight fever, site hot and swollen to touch and episodes of syncope daily since Flu Shot - Rx ADVIL taken helps headache.									N	09/08/2009	09/08/2009	0	No actual syncope; reports signs of dizziness or wooziness	OTH	OTH	ASA, 81 mg @ HS; PAXIL, 25 mg @ HS	None	Hx asthma; recent Dx bronchitis 8/09 went on PREDISONE then off but rxtn, Nephrotic  edema; Hyperglycemia -			1						1	Headache; Injection site swelling; Injection site warmth; Pyrexia; Syncope	FLU3~CSL LIMITED~06449111A~1~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357403	09/15/2009	PA	42.0	42		F	09/11/2009	Pt complained of right forearm tenderness, redness, swelling with below elbow circumference 26.5 cm on (R) arm. Left arm below elbow circumference 25 cm. Symptoms just noted in AM on 9/11/09. Prescribed warm compresses and MOTRIN.				Y						09/10/2009	09/11/2009	1	Right upper quadrant ultrasound.	PVT	PVT		None	Latex allergy; HTN; A-fib; Hypothyroid; Depression; Anxiety			1						1	Erythema; Oedema peripheral; Pain in extremity; Ultrasound scan	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA281AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0357406	09/15/2009	AZ	57.0	57		M	09/04/2009	Tingling in throat & cough for approximately 2 hours post vaccine. Resolved without medical therapy.									Y	08/31/2009	08/31/2009	0		PVT	PVT	N/A	N/A	N/A			1						1	Cough; Paraesthesia; Throat irritation	FLU3~SANOFI PASTEUR~U3201AA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357413	09/15/2009	TX	28.0	28		F	09/06/2009	Patient noticed numbness below elbow on day of receiving vaccine. It is slowing improving but not completely resolved.									U	09/03/2009	09/03/2009	0		OTH	PVT						1						1	Hypoaesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97843P2~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357418	09/15/2009	IA	17.0	17		F	09/09/2009	Eyes became red & sore, face red, breast sore (L). Wheezing, tightness in chest, pain inside & upper back. 2 hours after receiving flu vaccine. Pt took Tylenol, 9/8 went to ER & left without being seen. Called clinic 9/9 @ 9:00am.				Y					Y	09/08/2009	09/08/2009	0		PUB	PVT	Prenatal Vits, Tylenol		Pregnant, gallstones			1						1	Back pain; Breast pain; Chest discomfort; Erythema; Eye pain; Ocular hyperaemia; Wheezing	FLU3~SANOFI PASTEUR~U3187AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357422	09/15/2009	IL	18.0	18		M	09/08/2009	Patient fainted after receiving flu vaccine. RPh called 911, patient then woke 30 minutes later. 911 emergency was cancelled patient was fine.									Y	09/04/2009	09/04/2009	0		OTH	PVT						1						1	Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357427	09/15/2009	OH	20.0			F	09/11/2009	C/o left upper extremity numbness and weakness started 9/11/09 At 11:00am. O/E : decrease sensation in L thumb and tremor of L hand. Rx with ATIVAN 0.5mg @HS.				Y					Y	09/10/2009	09/11/2009	1		PVT	PVT	Prenatal Vitamins	none	30 weeks pregnant			1						1	Hypoaesthesia; Muscular weakness; Sensory loss; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA261AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0357438	09/16/2009	FL	27.0	27		F	09/16/2009	Diffuse hives and pruiritis- onset 2hrs after vaccination. Duration, 48hrs Tx'd with Benadryl and Hydrocortisone cream with good results.									Y	09/03/2009	09/03/2009	0		PVT	OTH	Albuterol		Allergy to PCN, Amoxil			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U3200AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357440	09/16/2009	MD	51.0	51		F	09/14/2009	Pt reported pain, redness and blister to left deltoid at injection site. Pt reported itching all over body. Pt advised to take BENADRYL for symptoms.									U	09/04/2009	09/05/2009	1		PVT	UNK	ALLEGRA-D 24 Hour 180-240 mg Tablet Extended Release 24 Hour; Aspirin 81 mg Tablet; Desoximetasone 0.25% Ointment; Fexofenadine HCl 180 mg Tablet; Fluticasone Propionate 50 mcg/ACT Suspension; Ketotifen Fumarate 0.025% Solution; Lisinopril		VICOPROFEN; Ciprofloxacin Tabs; Codeine derivatives; FLEXERIL; SKELAXIN Sulfa drugs; VICODIN			1						1	Injection site erythema; Injection site pain; Injection site vesicles; Pruritus generalised	FLU3~SANOFI PASTEUR~U3190AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~11624~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357445	09/16/2009	FL	54.0	54		F	09/16/2009	Throat constriction, stomach pains & diarhea, Shaking chills, Extreme exhaustion, Red eyes, itching, rash on forearms, confusion									Y	09/15/2009	09/15/2009	0		PUB	PVT		None	None			1						1	Abdominal pain upper; Chills; Confusional state; Diarrhoea; Fatigue; Ocular hyperaemia; Pruritus; Rash; Throat tightness; Tremor	FLU3~SANOFI PASTEUR~0.5~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357446	09/16/2009	TX	81.0	81		M	09/16/2009	Took Influenza & Pneumoccal shot at same time. Take Influenz every year with no reaction ever. I became aware things were not right aboput five hours after the shot.  Went to bed but did not sleep. Started to cough at intervals for 4-5 hours. Breathing was most difficult.  Could hardly get enough air. Stayed home next day & slept most of the day. Got up at 5:30pm and all was OK. Left w/minor cough at this stage.									Y	09/14/2009	09/14/2009	0		UNK	PVT	Atenelol 50mg 1xd; Plavix 70 mg 1xd; Pravastatan 80mg 1xd; Lisinopril 20mg 2xd; Zetia 10mg 1xd; Metformin 850mg 2xd; Propine/Dipivefrin 2xd; Iron 57mg 2xd FishOil 1200mg 2xd; Babt Aspirin 85mg 1xd	None	1984 Quad Bypass; 1994 Double bypass; 2000 Diagnosed with tyoe 2 Diabetis; 1980, 1985, 1990, 1995, Urethal Stones. None Since. Currently Arthritis Both knees. Taking Osteo By Flex 2 Tablets daily. Little progress.	None~ ()~NULL~~In Patient|None~ ()~NULL~~In Sibling1|None~ ()~NULL~~In Sibling2		1						1	Activities of daily living impaired; Cough; Dyspnoea; Insomnia; No reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357447	09/16/2009	ID	43.0	43		M	09/16/2009	Red and itchy eyes, upper back pain, sore throat, fever.				Y					U	09/15/2009	09/15/2009	0	ADVERSE REACTION TO FLU SHOT.	PVT	UNK	NONE	NONE	NONE			1						1	Back pain; Eye pruritus; Ocular hyperaemia; Oropharyngeal pain; Pyrexia	FLU3~SANOFI PASTEUR~U3203AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357448	09/16/2009	FL	40.0	39		F	09/16/2009	Individual called my office to report symptoms after receiving the Flumist 9/9/2009.  States on 9/11/2009 she developed flu-like symptoms including headache, nausea, muscle aches, temp of 38.7 and a cough.  She was her primary care physician and not given specific treatment.  She states she was not tested for H1N1 at that visit and denies exposure to anyone with the flu.  She said by 9/14/2009 her symptoms had resolved except for residual cough.									Y	09/09/2009	09/11/2009	2	None	MIL	PVT	Estrodial 1mf once a day, Calcium supplements, vitamens	None	Latex			1						1	Body temperature increased; Cough; Headache; Influenza like illness; Myalgia; Nausea	FLUN3~MEDIMMUNE VACCINES, INC.~500673P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0357449	09/16/2009	LA	33.0	33		F	09/16/2009	Received flu shot at 0900 am September 15, 2009. At 8 pm that night started getting a bad headache. At 9 pm felt as if I had fever and chills. Severe muscle aches in legs, arms, and lower back pain. Generalized fatigue, sore throat, nausea. Called in to be off work at 12 am 9-16-09. Unable to sleep due to severe muscle aches. Temp. was only 98.9F but I had chills and felt feverish. Awoke 9-16-09 and did not have any more muscle aches. I have a slight headache and a sore throat. I considered going to the hospital last night because my muscle aches were so severe but did not go because I did not have fever.Feel better this morning but am wary of getting the flu shot again.									Y	09/15/2009	09/15/2009	0	n/a	PUB	PUB		none	none / nka			1						1	Activities of daily living impaired; Back pain; Chills; Fatigue; Headache; Insomnia; Myalgia; Nausea; Oropharyngeal pain; Pain in extremity; Pyrexia	FLUX~UNKNOWN MANUFACTURER~0000000~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0357451	09/16/2009	MI	5.0	5		M	09/16/2009	LEFT LEG BECAME SWOLLEN AND RED, ITCH, BLOTCHY VERY UNCOMFORTABLE									Y	09/14/2009	09/16/2009	2		PVT	PVT			CEREBRAL PALSY			1						1	Injection site discomfort; Injection site erythema; Injection site pruritus; Injection site swelling; Rash macular	DTAP~SANOFI PASTEUR~C3157AA~5~IM~LL~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500695P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~D0413~4~IM~LL~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0357453	09/16/2009	MD	0.5	0	.6	M	09/16/2009	RECEIVED VACCINES AT APPROX 1430 ON 09/09/09 APPROX 11 HOURS LATER PATIENT SENT TO ER FOR POSSIBLE SIEZURES.  NO PRIOR HISTORY OF SEIZURES.PATIENTS JEARKING MOTION LASTED ABOUT 20 MINUTES.  WHILE IN ER PATIENT HAD JERKING MOTIONS AGAIN.  ATTENDING WAS CONCERNED ABOUT SEIZURES VS INFANTILE SPASMS				Y					Y	09/09/2009	09/10/2009	1		PVT	PVT	NONE	N/A	N/A			1						1	Dyskinesia	DTAPIPVHIB~SANOFI PASTEUR~C3432AB~1~IM~RL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~UT317CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~D78696~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0147X~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0357455	09/16/2009	OH	39.0	39		F	09/16/2009	APROXIMATELY 40HRS AFTER RECIEVING FLUMIST VACCINATION, PATIENT WOKE UP WITH SORE THROAT AND SWOLLEN TONGUE. APROX. 12 HRS LATER TONGUE INCREASED SWELLING AND THROAT WAS ALSO NOW SWELLING. TOOK 50MG BENADRYL BREATHING WAS EASIER AND CALMED OTHER SYMPTOMS AS WELL. NEXT DAY UPON AWAKING TONGUE STILL SWOLLEN THROAT SCRATCHY. THAT EVENING INCREASED SWELLING OF TONGUE AND THROAT ACCOMPANIED BY GAGGING, TOOK 50MG OF BENADRYL AND WENT TO E.D. WAS PRESCRIBED 20MG PREDNISONE FOR 5 DAYS.  9/17/09 Received ER medical records of 9/14/2009. FINAL DX: possible allergic reaction Records reveal patient experienced swollen tongue & throat, feeling weird.  Initially resolved w/Benadryl but recurred & worsened w/gagging & anxiety.  Tx w/additional Benadryl & steroids.  D/C to home on continued meds w/PCP f/u.			Y	Y					Y	09/11/2009	09/13/2009	2	HAS BEEN REFERRED TO ALLERGIST	MIL	MIL	SYNTHROID, BCP	N/A	LATEX AND BEE ALLERGY  9/17/09 Received medical records w/PMH: T&A.  Allergy: Demerol.			1						1	Oropharyngeal pain; Pharyngeal oedema; Retching; Swollen tongue; Throat irritation	FLUN3~MEDIMMUNE VACCINES, INC.~500697P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Life Threatening	Influenza
0357456	09/16/2009	TX	67.0	67		F	09/16/2009	Employee states that after 2 hours of getting the Flu Vaccine she had blurred vision which lasted for a few minutes.									Y	08/28/2009	08/28/2009	0	None	PUB	PVT	None Known	None known	None Known			1						1	Vision blurred	FLU3~SANOFI PASTEUR~U3192AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357457	09/16/2009	ND	61.0	61		F	09/16/2009	After receiving the seasonal flu shot on 9-14-2009 That evening, night and all the next day I had arthritis like pain in all the joints in the arm of the vaccination. It lated until this morning Wed the 16th and now has resolved. No tenderness or redness in the site bit extreme stiffness and joint pain in all the rightarm joints									Y	09/14/2009	09/14/2009	0		PUB	PVT	None	None	BACTRIM CECLOR IVP DYE KEFLEX SEASONAL ALLERGIES MENOPAUSE			1						1	Arthralgia; Joint stiffness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA25588~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0357459	09/16/2009	OH	48.0	48		F	09/16/2009	Received the flu shot around 4:30-5:00 on 9/15/09. Around 9-9:30 that night, I started experiencing adverse symptoms that included: coughing, wheezing, throat swelling closed, inability to swallow without severe pain, extreme salivation (making the swallowing part even more difficult), also felt like I had drainage in the back of my throat but couldn't clear my throat, fever (not low grade but didn't get an actual), severe joint pain (every joint felt like it was being torn in half), severe pain in the shot arm including being unable to move the arm. I should have went to the ER, but didn't because of the cost. Where I live, we have a great 911 system/service so I knew I could receive help within minutes. Had I lived somewhere that didn't have a great 911 system, I would definitely have went to ER when my throat swelled closed. So I checked required er/dr visit in the next section. Upon waking this morning, I was only slightly feverish, throat is slightly irritated, very tired, headache, shot arm is only tender now, but my face is very swollen (specifically lips & eyes) and my eyes are crusted over.				Y					Y	09/15/2009	09/15/2009	0	In #13 - I have no idea the manufacturer of the vaccination but to hit submit I have to choose. Again.. DON'T KNOW MANUFACTURER!	PVT	UNK	On 9/14 had taken fioricet for migraine - 3 doses for a total of 5 pills. On 9/15 in the morning, had taken 1 oracea pill.	none	sulpha			1						1	Arthralgia; Cough; Dysphagia; Eye discharge; Eye swelling; Fatigue; Feeling hot; Headache; Injected limb mobility decreased; Lip swelling; Oropharyngeal pain; Pain in extremity; Pharyngeal oedema; Salivary hypersecretion; Swelling face; Throat irritation; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~don't know manu~UNK~~~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0357461	09/16/2009	IN	34.0	34		F	09/16/2009	Within a half an hour, I began to sweat profusely and feel lightheaded/dizzy followed by a headache.  I felt disoriented.  By several hours later, my arm was numb.  That night, I woke up numerous times sweating and aching.  My arm is still numb, tingling and prickly.  I am irritable and achy with a headache yet today.										09/15/2009	09/15/2009	0	None	UNK	UNK		Poison ivy	none			1						1	Disorientation; Dizziness; Headache; Hyperhidrosis; Hypoaesthesia; Irritability; Pain; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~U3203AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0357464	09/16/2009	PA	55.0	55		F	09/16/2009	received influenza vaccine 9/14/2009 @1200 L deltoid . developed redness, tenderness , itching at site within 24 hours. Symptoms subsiding at time of evaluation 9/16/2009 @ 1400, with rednesss 4cm x 2.5 cm no induration. mild itching no pain recommended warm compresses. po benadryl for itching otc prn every 6 hours									U	09/14/2009	09/15/2009	1		PUB	MIL	none	no	none			1						1	Injection site pain; Injection site pruritus; Injection site reaction	FLU3~CSL LIMITED~08149111A~5~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357465	09/16/2009	IN	45.0	45		F	09/16/2009	extreme fatigue, tingling of left arm (especially ring & pinky fingers  treated with Aleve									Y	09/15/2009	09/15/2009	0	none	UNK	UNK		none	mild asthma			1						1	Fatigue; Paraesthesia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357467	09/16/2009	WA	42.0	42		F	09/16/2009	Swelling started soon after the shot on 9/14/09.  Arm is itchy and sore.  9/16 arm is very itchy and sore, it feels like it's in her shoulder.  She feels hot, chills, but no fever (97.8 oral).				Y					U	09/14/2009	09/14/2009	0		UNK	PVT	HCTZ, thyroid replacement	none	HTN, hypothyroidism			1						1	Chills; Feeling hot; Pain in extremity; Pruritus; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA276AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0357468	09/16/2009	PA	56.0	56		F	09/16/2009	Received shot on Sept 14 at 1:30PM in left arm. A few hours later arm was sore. The next morning, entire arm & hand felt like it fell asleep. The armpit is swollen. the second morning arm & hand has a tingleing sensation and still swallon. Went to my primary physican. She prescribed, ice on arm pit and antihistamine.				Y					N	09/14/2009	09/14/2009	0		UNK	UNK		NONE				1						1	Hypoaesthesia; Joint swelling; Lymphadenopathy; Pain in extremity; Paraesthesia; Injection site anaesthesia; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~66521011210~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848P1C~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0357469	09/16/2009	WA	14.0	14		F	09/16/2009	Pt was to receive Gardasil #1, Fluvirin, and Menactra. She did receive Gardasil and Fluvirin but was given Prevnar in error. Had soreness of both arms the day of injection. The next morning she developed fever initially to 100.2F, chills, and dizziness. Over the next 3 days she had fever to 102F, and nausea as well.									U	09/10/2009	09/11/2009	1		PVT	PUB		none	short stature			1						1	Chills; Dizziness; Nausea; Pain in extremity; Pyrexia; Wrong drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~96030 4P~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HPV4~MERCK & CO. INC.~0671Y~2~IM~RA~HPV (GARDASIL)~1|PNC~PFIZER\WYETH~D48928~7+~IM~LA~PNEUMO (PREVNAR)~1	USA		Influenza
0357471	09/16/2009	UT	81.0	81		F	09/16/2009	Patient complained of agitation, tremors of hands and headache.  Required a quiet place to sit.  Determined this was not her usual behavior.  Provided her lunch tray at 11:45 and encouraged her to eat something, but refused.  Monitored for 45 minutes.  Stated feeling a little better - friends drove home and would stay with her and amke sure she ate.  If her symptoms did not improve they stated they would take her to the community clinic.									U	09/16/2009	09/16/2009	0		PUB	PUB						1						1	Abnormal behaviour; Agitation; Diet refusal; Headache; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA468BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0357478	09/16/2009	TX	35.0	35		F	09/16/2009	RASH AT INJECTION SITE CONSISTENT WITH SIZE OF BANDAGE;MOVEMENT OF LIMBS (ARMS & LEGS) CAUSES PAIN; PELVIC AREA PAIN; HURTS TO BEND REPORT TO RPh ON DUTY									U	09/15/2009	09/15/2009	0		UNK	UNK						1						1	Injection site rash; Pain in extremity; Pelvic pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960315P~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357482	09/16/2009	NC	58.0	58		F	09/16/2009	Beginning 9/15/09 at 6 or 7 PM EST patient reported hurting in her back and stomach. Chills and a fever (100 degrees F), vomiting, diarrhea at 5AM 9/16. Headache and aching all over. Patient reported being dehydrated, vomiting yellow bile. Diarrhea was grass green and watery.									N	09/14/2009	09/15/2009	1		OTH	UNK	COREG; Trazodone; Sertraline; Alprazolam;  BUDEPRION XL; LYRICA	None	heart attack 3/09; broken R ankle; neuropathy			1						1	Abdominal pain upper; Back pain; Chills; Dehydration; Diarrhoea; Faeces discoloured; Headache; Pain; Pyrexia; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357483	09/16/2009	IA	42.0	42		F	09/16/2009	Patient complained feeling slight faint and thirsty; withheld fluids to monitor. Patient later complained of tickle in throat but said no problems breathing; we continued to monitor, then patient complained of itching all over. Called 911, while putting on gloves and getting epi pen paramedics arrived and took over care, pt was taken to local ER for treatment.				Y					Y	09/16/2009	09/16/2009	0		OTH	PVT	Atenolol; Chlorthalidone	None	Unknown physician diagnosed conditions.			1						1	Dizziness; Pruritus generalised; Thirst; Throat irritation	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357485	09/16/2009	SC	79.0	79		F	09/16/2009	Right after vaccine administered bled a small amount and then swelled to a small hard lump. Pt waited in store for 35-40 minutes and looked to have sore arm. Pt only had local rx. After 3 hours- we called pt and swelling was going down.									U	09/16/2009	09/16/2009	0		OTH	UNK						1						1	Immediate post-injection reaction; Injection site haemorrhage; Injection site induration; Injection site pain; Injection site swelling; Local reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~9783982~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357486	09/16/2009	MI	49.0	49		F	09/16/2009	Received injection 10:30am within one hour nausea, aching, burning cough. 7:00 returned to clinic with symptoms. Conferred with Dr, Motrin 400mg 6-8 hours as needed and Compazine 10mg every 6 hours as needed. Freq small amount of fluids.									Y	09/14/2009	09/14/2009	0	9/16/09 at 5:53pm - doing well strongly believes was reaction to vaccine.	OTH	OTH	None	None	None			1						1	Cough; Nausea; Pain; Throat irritation	FLU3~SANOFI PASTEUR~U3209AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357487	09/16/2009	OH	74.0	74		F	09/16/2009	Serious swelling of upper arm, shoulder and right abdomen. Limited mobility of right arm.				Y					U	09/15/2009	09/16/2009	1		OTH	PUB	Lorazepam;  Lunesta					1						1	Abdominal distension; Injected limb mobility decreased; Joint swelling; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~9784081~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357489	09/16/2009	KS	5.0	5		F	09/16/2009	Approx 30-40 min after receiving a influenza vaccine, the patient's mother noticed bilat swelling around eyes.  No other hives noted.  No redness or swelling noted at injection site.  Lungs CTH bilat.  No tongue swelling noted.  Recommended BENADRYL be given + monitor for further symptoms.									Y	09/16/2009	09/16/2009	0	No known history of allergy to eggs.  Pt does have history of environmental allergies.	PUB	PVT			Environmental allergies			1						1	Eye swelling	FLU3~SANOFI PASTEUR~U3212AA~3~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357490	09/16/2009	CA	13.0	13		U		Patient received vaccine 9/14/09 & developed left arm/chest T2/T4 distribution shingles like syndrome s/p injection in left arm.  He received vaccine at outside facility. Tx in process.									U	09/14/2009	09/15/2009	1		OTH	UNK		Denies	None			1						1	Herpes zoster	FLU3~GLAXOSMITHKLINE BIOLOGICALS~06949116A~UNK~IJ~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0357493	09/16/2009	MN	76.0	76		M	09/16/2009	None stated.									Y	09/10/2009				PVT	PVT		None	None	none~ ()~~0.00~Patient		1						1	Unevaluable event	FLU3~SANOFI PASTEUR~43203AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357494	09/16/2009	MN	65.0	65		F	09/16/2009	Given FLUZONE vaccine injection on 9-4-09; family came in to clinic on 9-10-09 and received flu vaccine injection again a 2nd time.									Y	09/10/2009				PVT	PVT		None	None			1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U3203AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357496	09/16/2009	PA	73.0	73		M	09/16/2009	Vaccinated 9-12-2009 @ 3:15PM. Sat 9/12 patient reports he slept lousy. Sun 9/13 didn't feel right. Kind of a sore throat. Mon - Wed 9/14-9/16 sniffles, coughing. Sneezing no temp. Not phlegm. Tightness in chest sweating off +/on.										09/12/2009	09/12/2009	0	-None- Did not see physician however. Call/visit recommended if symptoms persist.	OTH	OTH	CRESTOR; LEVITRA; FLOMAX; ZETIA; lisinopril; Gemfibrozil	No acute illness; Not sick				1						1	Chest discomfort; Cough; Feeling abnormal; Hyperhidrosis; Oropharyngeal pain; Rhinorrhoea; Sleep disorder; Sneezing	FLU3~SANOFI PASTEUR~U3184AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357497	09/16/2009	MO	79.0	79		F	09/15/2009	Pt complained of severe arm pain. Stated that the vaccine was given very high by shoulder. Pain unrelieved by pain med. MD wants to see her.				Y					N	09/10/2009	09/10/2009	0		OTH	OTH						1						1	Drug administered at inappropriate site; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357498	09/16/2009	CA	71.0	71		M	09/08/2009	At 9:30 PM (4 hrs after injections/ pt went to ER with SOB, pain and inflammation (RT) arm. F/u with primary on Friday 9/14/09. Pt forgot he had pneumonia shot last May!				Y					Y	09/01/2009	09/01/2009	0		UNK	UNK						1						1	Dyspnoea; Inappropriate schedule of drug administration; Inflammation; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0627Y~1~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0357499	09/16/2009	IL	86.0	86		F	09/16/2009	Pt experienced unusual swelling and muscle pain/ache. Refused to go to hospital, but MD was contacted by patient. Left deltoid experienced swelling to half baseball size per pt, with no redness or SOB. Swelling decreased after 24 hours.									Y	09/15/2009	09/15/2009	0		OTH	PUB	Isosorbide; Methotrexate; LEVEMIR; NOVALOG; COMBIVENT; Potassium; Furosemide; LEXAPRO; Hydroxyzine; AMBIEN; PLAVIX; Clonidine; Gabapentin;	none				1						1	Injection site swelling; Myalgia; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0627V~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357500	09/16/2009	FL	46.0	46		M	09/14/2009	Pain, redness & swelling at site, R arm swelling of lips.  Developed blisters in mouth at time of visit, esophageal restriction, dysphasia, fatigue, tachycardia.				Y					Y	09/12/2009			None	PVT	PVT	TYLENOL; CELEBREX; tramadol;  PREVACID; ALLEGRA; amitriptyline; LYRICA	No apparent	No Known Drug Allergy; HA;  Arthritis; Carpal tunnel;  Hip knee; Back surgery			1						1	Dysphagia; Fatigue; Injection site erythema; Injection site pain; Injection site swelling; Lip swelling; Oesophageal disorder; Oropharyngeal blistering; Tachycardia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P2~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0867X~1~UN~RL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0357501	09/16/2009	TX	22.0	22		F	09/26/2009	Approx. 2 1/2 - 3 hours after injection, faint like s/sx; felt throat closing.  EMS called - VSS, BB 245, patient wanted transport to ER.  Was told she was dehydrated & given 2 l fluids.  Back to work on 9/16.				Y					Y	09/15/2009	09/15/2009	0		OTH	OTH		None	None			1						1	Dehydration; Dizziness; Throat tightness	FLU3~SANOFI PASTEUR~U3186AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357502	09/16/2009	TX	9.0	9		F	09/16/2009	Pt developed redness of about 3 1/2 inches in length and 2 inches wide.  Site was hard, hot to touch, and also very painful.									Y	09/14/2009	09/15/2009	1		UNK	PUB		None				1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U3185AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0868X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357504	09/16/2009	MA	15.0	15		M	09/16/2009	Nausea and vomiting s/p flu vaccination, afebrile (a 1 hour duration, 2-3 hours s/p injection). Rest and fluid recommended treatment, call back if sxs worsen, no call back.									U	09/09/2009	09/09/2009	0		PVT	PVT		healthy	Exercise induced asthma; allergic rhinitis			1						1	Nausea; Vomiting	FLU3~SANOFI PASTEUR~U3209AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357505	09/16/2009	KY	31.0	31		F	09/15/2009	Patient received FLUZONE shot - about 15 minutes later, patient & her mother returned to pharmacy because patient felt dizzy.  Patient turned pale and was cold and clammy.  She passed out for about 30 seconds.  She came to when I was ready to give EPI-PEN shot & informed me at that time of Tachycardia & shunt.  Patient said tongue was swelling and metallic taste.  Ambulance was called immediately when patient felt like she was going to pass out (patient gave permission for ambulance to be called.  She passed passed out while I was on the telephone calling 911.  No medicine was given.				Y					Y	09/15/2009	09/15/2009	0		OTH	OTH		None	None reported until after vaccination.			1						1	Cold sweat; Dizziness; Dysgeusia; Feeling cold; Loss of consciousness; Pallor; Swollen tongue	FLU3~SANOFI PASTEUR~U3191AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357508	09/16/2009	KY	31.0	31		F	09/14/2009	Day after flu shot patient relied complaining of numbness in her left side and hoarseness in her throat.  I referred her to ER since the phone # on VIS form thought could be Guillain Barre.  I called her two days after shot and numbness was improving but throat swollen.  Recommended ER again and couldn't breathe.  Pt taking BENADRYL & calling MD next day.									Y	09/11/2009	09/11/2009	0		OTH	OTH	SINGULAIR	None	CECLOR;  Mold;  Deg Disk Disease	arm swelling~Influenza (Seasonal) (no brand name)~UN~0.00~Sibling		1						1	Dysphonia; Hypoaesthesia; Pharyngeal oedema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357743	09/16/2009	RI	75.0	75		F	09/16/2009	Most painful shot ever gotten, walked home afterwards arrived by noon and started shaking all over chills. Put blanket on, could not lift glass of water, chills persisted for 5 hours. During kept drinking water and ate something. Probably had fever over night because woke up wet with perspiration. Called doctor on 9/15. On 9/15 felt weak could hardly walk, wiped out/tired, slept for about 12 hours. Today still feels weak. Took no medications.									U	09/14/2009	09/14/2009	0		PUB	PVT	Coumadin, lanoxin, cardizen CD, toprol XL, aspirin.	1 week before had sinus infection	Sinus comes and goes, stomach ulcer, kidney problems, osteoporosis, eye problems due to small stroke, brain aneurysm about 10 years ago. During brain surgery had reaction to 1 of the following medications: seldane, hismanal, sotals, variomycin, rocephin, erythromycin, estrioxene, ees.			1						1	Asthenia; Chills; Fatigue; Gait disturbance; Hyperhidrosis; Hypersomnia; Injection site pain; Pyrexia; Tremor	FLU3~CSL LIMITED~02649211A~1~IJ~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357468	09/17/2009	PA	56.0	56		F	09/16/2009	Patient reported tingling and numbness at injection site.									U	09/14/2009	09/14/2009	0		OTH	PVT		None	None			1						2	Hypoaesthesia; Joint swelling; Lymphadenopathy; Pain in extremity; Paraesthesia; Injection site anaesthesia; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~66521011210~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848P1C~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0357480	09/17/2009	WA	3.0	3		M	09/17/2009	Received Hep A and Flu Mist on 12/11. Next day ( 12/12 noticed involuntary hand jerking a few times during day. Noticed again following day 12/13. Called on call nurse and she didn't think it was anything to be concerned about. Next day 12/14 started running fever. Gave Tylenol to son when fever continued to climb. An hour or so later he had a Grand Mal seizure lasting approximately 3-4 minutes. Called 911. Remained completely unresponsive to paramedics and parents. Went to hospital and patient was unresponsive for approximately 3 hours (no eye contact, staring at the light, didn't recognize or respond to anyone...a vegetative type state) After approximately 3-4 hours he snapped out of it and became responsive. Fever conitnued for approx. 2-3 more days. Unusual symptoms/behaviors following seizure (don't know if they were related) included eye twitching, complaint of periodic chest pain and complaints that face felt tingly/dry for months afterward. Chronic throat infections followed resulting in tonsilectomy in March 2009. Prior to the flu mist patient had never had the involuntary hand twitching ( fists ball up and both hands jerking inward). He had many fevers prior to this incident and never had a febrile seizure. I think that the flu mist was the cause of this. We do adore and respect our doctor - so I hope that this can be filed confidentially. We just feel that it is our responsibility to report the incident.				Y					Y	12/11/2008	12/14/2008	3		UNK	UNK	N/A	No	Ear infections resolved by ear tubes.	Fever, swelling & vomitting~Measles + Mumps + Rubella (no brand name)~1~1.00~Patient		1						1	Blepharospasm; Chest pain; Dry skin; Dyskinesia; Grand mal convulsion; Paraesthesia; Pharyngitis; Pyrexia; Tonsillectomy; Unresponsive to stimuli	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB258AA~2~~~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0357507	09/17/2009	MI	0.52	0	.5	F		Had nasal congestion for 2-3 days prior to imms. Then the night after the imms developed fever and rapid breathing and was assessed in the ER and X-ray indicated possible pneumonia/inflammation. Pt was admitted for abx and discharge 2 days later. Normal today (9-15-09).  10/05/09 Received hospital medical records of 9/12-9/14/2009. FINAL DX: Pneumonia Records reveal patient experienced nasal congestion, dry cough x 2-4 days.  Seen for vaccinations day prior to admit.  Developed fever & increased respiratory rate w/retractions following day.  Temp in ER 102.3 & in respiratory distress.  Tx w/IV antibiotics.  Improved & d/c to home on continued oral antibiotics. ICD9 codes: 486, 6233, 78791, 53081				Y	Y	2			Y	09/11/2009	09/12/2009	1	Chest X-ray; Blood work  10/5/09 Medical records received w/LABS: CXR c/w atelectasis vs pneumonia.  WBC 17.9(H).  Bicarb 18(L).  Influenza A&B, blood c/s, urine c/s neg.	UNK	UNK		Viral illness (non-febrile)	Premature; GERD; Hx of apnea; Hx of tachypnea  10/5/09 Medical records received w/PMH: 29 wk preemie w/intubation			1						1	Nasal congestion; Pyrexia; Respiratory rate increased	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B2090A~UNK~IM~LL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT3173GA~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF707AA~UNK~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~D46874~UNK~IM~RL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0319Y~UNK~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Hospitalisation	Influenza
0357524	09/17/2009	MD				F	09/14/2009	Initial information was received on 04 September 2009 from a consumer. A female patient with no reported past medical history received an influenza vaccine on an unspecified date (manufacturer, lot number, route, site of administration and number of previous doses were not reported). Following vaccination, the patient stated that she developed diabetes. She also reported that her diabetes medication (medication not specified) caused her heart problems. No additional information was provided. List of Documents held by sender: none.				Y					U				not reported	UNK	UNK			not reported		200903871	1						1	Adverse drug reaction; Cardiac disorder; Diabetes mellitus	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0357530	09/17/2009	OH	81.0	81		M	09/17/2009	Patient experienced nausea and runny nose within 24 hours of vaccine administration.									Y	09/14/2009	09/15/2009	1	None	MIL	UNK		CAD, s/p CABG, BPH, GERD, HTN	Iodine, atorvastatin			1						1	Nausea; Rhinorrhoea	FLU3~CSL LIMITED~07349111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357532	09/17/2009	VA	68.0	68		F	09/17/2009	Fever 100-101.4 developed approx. 18 hours after vaccine. Had the fever for 2 days. Muscle and joint aches for 2 days. Slept an unusual amount for 3 days. Right arm, fire red area about 5 inches long around the vaccine site and extreme soreness and pain in the area, unable to raise the arm due to the discomfort. Red area has taken about four days to decrease and now the red area is the size of a quarter. The area is still very tender to touch and there is a golf ball size lump around the injection site. Also, diarrhea and cramping for 5 days. Only treatment was Tylenol.										09/11/2009	09/12/2009	1		UNK	UNK		No				1						1	Activities of daily living impaired; Arthralgia; Diarrhoea; Injected limb mobility decreased; Injection site erythema; Injection site mass; Injection site pain; Muscle spasms; Myalgia; Pyrexia; Tenderness	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1163x~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357534	09/17/2009	NY	0.83	0	.8	M	09/17/2009	CBC obtained 3 days post influenza vaccine, demonstrated neutropenia (ANC 650) and mild thrombocytopenia (plt 150). Patient otherwise well and asymptomatic. There is a possibility results may be spurious.									U	09/11/2009	09/14/2009	3	WBC 5.9, Neutrophils 11.0%, Lymphocytes 75.0%, platelets 150.	PVT	PVT	None	None	None			1						1	Lymphocyte percentage increased; Neutropenia; Neutrophil percentage decreased; Platelet count normal; Thrombocytopenia; White blood cell count	FLU3~SANOFI PASTEUR~UT3171CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357535	09/17/2009	KS	58.0	58		F	09/17/2009	Approx. 12:30 p.m. Inluenza injection given.  Approx. 3:30 p.m. client reports began feeling short of breath.  Approx. 4 p.m. client returned to our office.  Was SOB, face appeared slighly swollen, apprehensive, just not feeling well. No rash or redness noted anywhere on clients body or at injection site. Administered 25 mgs  2 capsules, po of Benadryl per standing order for reaction.  Client began vomiting and became clammy shortly after taking medication and vomited medication.  Continued to have c/o breathing problems.  BP 158/85, Pulse 71, Spo2 above 90%.  911 was called. 02 placed on client.  Client continued to be SOB, vomiting.  Client was transported to ER for further evaluation.   First influenza vaccine client had ever received.  Client has history of PAD. (Peripherial artery disease)				Y					Y	09/16/2009	09/16/2009	0		PUB	PVT		History of PAD				1						1	Anxiety; Cold sweat; Dyspnoea; Malaise; Oxygen saturation decreased; Swelling face; Vomiting	FLU3~SANOFI PASTEUR~U3186AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357540	09/17/2009	OH	19.0	19		F	09/17/2009	Swelling at injection site which got worse on 9/16/09 then better on 9/17/09. Also itching around the injection site.									Y	09/14/2009	09/14/2009	0		UNK	PVT						1						1	Injection site pruritus; Injection site swelling	FLU3~SANOFI PASTEUR~u3209~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357542	09/17/2009	WI	45.0	45		F	09/17/2009	Influenza vaccine administered at 7:30 am. By 10:00 am developed sore throoat, cough, progressed to chest tightness difficulty swallowing by 11:30 am. Directed employee to the ER for treatment				Y					Y	09/16/2009	09/16/2009	0		PUB	PVT		None	Gentamycin			1						1	Chest discomfort; Cough; Dysphagia; Oropharyngeal pain	FLU3~SANOFI PASTEUR~U3211AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357543	09/17/2009	NM	10.0	10		F	09/17/2009	Fever of 104 degree noted by school nurse.									Y	09/10/2009	09/11/2009	1		PVT	UNK						1						1	Pyrexia	FLU3~SANOFI PASTEUR~U3177AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0811Y~2~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0357544	09/17/2009	AR	2.0	2	.8	F	09/17/2009	scratching/clawing at eyes     crying										09/16/2009	09/16/2009	0		PVT	PUB		none	none			1						1	Crying; Eye irritation	FLUN3~MEDIMMUNE VACCINES, INC.~500678P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0357545	09/17/2009	MN	29.0	29		F	09/09/2009	Severe dizziness, nausea, vomiting, hot sweats.  Occurred a little over 20 hrs & lasted 24 - 48 hrs.  No fever.									Y	09/01/2009				PUB	OTH		None				1						1	Dizziness; Feeling hot; Hyperhidrosis; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U3200AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357546	09/17/2009	OH	19.0	19		M	09/12/2009	About 5 min after vaccination, pt c/o dizziness, feeling like he was blacking out. Pt was able to lay down with feet elevated. BP was taken. Felt better 20 within 20 min. F/u call @ 3pm-doing fine.									Y	09/11/2009	09/11/2009	0	BP readings 9:38am 122/80, 9:43am 122/80; 9;48 am 108/72	OTH	UNK						1						1	Dizziness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357564	09/17/2009	SC	34.0	34		F	09/17/2009	Received T/C from patient.  States received Flu vaccine on Monday, September 14, 2009 in left deltoid.  States immediately felt a pain in her left side of neck.  Did not report to the nurse who admninistered the vaccine.  States did not have any pain at injection site or redness.  No pain down her arm.  No numbness or tingling in her arm.  No other signs/symptoms.  States is improving.  Has done no OTC treatment, i.e ice/heat, meds.									Y	09/14/2009	09/14/2009	0	None	UNK	UNK	Yaz - BCP, Glucosmaine Chondroitin	Getting over a cold, States was relaxed	None		SC0924	1						1	Immediate post-injection reaction; Neck pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLL259AA~6~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0357565	09/17/2009	PA	38.0	38		F	09/17/2009	rash on chin, abdomen, and both arms.  Lips began to swell.  patient took 2 doses of benadryl liquid.  swelling of lips did not decrease, so she went to the emergency room.  ER MD prescribed prednisone and benadryl.				Y					Y	09/11/2009	09/11/2009	0		UNK	PVT						1						1	Lip swelling; Rash	FLU3~SANOFI PASTEUR~U3209aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357568	09/17/2009	MN	25.0	25		F	09/17/2009	approx. 12 hrs after vaccine I started shaking uncontrollablly, and was extremely cold, I could not warm up. Temp. was 98.6. Put 8 heavy blankets on me and still could not warm up, my heart was racing. after about 3 hrs of that then I got hot, very hot (I think from all of the blankets on me) my temp was then 101. Heart still racing. I slowly tried to cool down, but of course when taking blankets off I was still cold and shaking. I could not sleep and my heart was still racing, I finally fell asleep and got about 4 hrs of sleep, woke up and felt better, still a little weak and tired from not sleeping and from shaking, but felt fine over all. DUring all this, I did consider going to the ER, due to the uncontrollable shaking and heart racing, but just stayed home.									Y	09/10/2009	09/10/2009	0		PVT	PVT	prenatal vitamin	none	sulfa			1						1	Asthenia; Body temperature increased; Fatigue; Feeling cold; Feeling hot; Palpitations; Sleep disorder; Tremor	FLU3~CSL LIMITED~05849111A~7+~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357570	09/17/2009	TN	22.0	22		F	09/17/2009	Patient broke out in hives/rash within minutes of administration. No respiratory distress or edema noted by physician, no other complaints of symptoms made by patient.									Y	09/14/2009	09/14/2009	0	None	PVT	PVT	Benadryl given after reaction.	Glossitis	Epilepsy, Hypothyroidism			1						1	Immediate post-injection reaction; Rash; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLA256AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0357571	09/17/2009	KY	51.0	51		F	09/17/2009	c/o of itching at the site of injection immediatatley after injection. 1 hour later: c/o headache, numbing at mouth/lips, pale progress to thighness in chest and nausea				Y					Y	09/11/2009	09/11/2009	0	chest xray and EKG	UNK	UNK	Zoloft, Imitrex, Tropramax, Allergy shots weekly	denies	Allergies,migraine headaches			1						1	Chest X-ray; Chest discomfort; Electrocardiogram; Headache; Hypoaesthesia oral; Immediate post-injection reaction; Injection site pruritus; Nausea; Pallor	FLU3~SANOFI PASTEUR~U3202AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357572	09/17/2009	OH	32.0	32		F	09/16/2009	Pain in Left Shoulder where vaccine was given.  Soreness, red, swelling at injection site (hive).  Pain lasting two days and counting.									Y	09/14/2009	09/14/2009	0		PUB	PUB			Allergy to PCN			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site urticaria	FLU3~SANOFI PASTEUR~U3192AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357573	09/17/2009	NY	4.0	4		F	09/17/2009	Patient is a 4 year old female brought by father presenting with drug reaction. On Saturday woke up at 8AM woke up with swelling on right leg.  By 2PM much more swollen and red from knee to hip. Gave motrin with some relief.  Tuesday evening had rash all over body with itching. Went to ER 1AM Tuesday where Rxed prelone and benadryl.  Hasn't started prelone yet.  Sleeping well, no fever, normal appetite and bowel movement . OBJECTIVE: BP 84/50 | Pulse 118 | Temp(Src) 97.3 F (36.3 C) (Oral) | SpO2 98%  Patient is alert and oriented , cooperative, cheerful Skin: urticaria on buttuck, both lower extremities and back Lips cracked, not swollen No rash on buccal mucosa Lungs clear Abdomen benign  ASSESSMENT: 909.5 ADVERSE EFFECT TO DRUG/MEDICATION  (primary encounter diagnosis) Comment:   Plan: CLARITIN 5 MG/5ML OR SYRP Use benadryl as second line antihistamine. Use every 4 hours as needed Take prednisolone for 3 days, then stop				Y					N	09/10/2009	09/12/2009	2		UNK	UNK		none	none			1						1	Chapped lips; Injection site erythema; Injection site swelling; Pruritus; Rash generalised; Urticaria	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B136AA~5~IM~RL~DTAP + IPV (KINRIX)~1|FLUX~SANOFI PASTEUR~U3167BA~3~UN~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~1580X~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0973Y~2~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0357574	09/17/2009	IA	93.0	93		F	09/17/2009	Redness and swelling from the shoulder to the elbow									U	09/16/2009	09/16/2009	0		UNK	PUB			NKDA, hypertension			1						1	Erythema; Oedema peripheral	FLU3~CSL LIMITED~07949111a~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~1125x~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357577	09/17/2009	NM	49.0	49		F	09/17/2009	arm described by employee as swollen 3-4 inches below injection site, red and warm to touch				Y					Y	09/15/2009	09/17/2009	2		PVT	UNK		being treated for anemia				1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97845P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357578	09/17/2009	TX	13.0	13		F	09/17/2009	The study subject is a 13-year-old female with a history of reactive airway disease and nasal allergies who received Fluzone through our school-based influenza vaccination program. The subject complained of a headache and a closed throat within a short time of receiving the influenza vaccine in the morning of August 28th. Physical examination revealed an alert and oriented child in no evidence of respiratory distress, and on auscultation she had clear breath sounds without wheezing. Emergency medical team (EMT) arrived at 13:25. The initial vital sign revealed a BP of 130/90, HR of 100 beats/minute and 98% oxygen saturation. She was moving air well but was unable to take deep breaths. She was given 50 mg of Benadryl (suspension) and had no difficulty swallowing. Urticaria developed on her face. She complained of shallow breathing, tongue hurting, chest pain and difficulty swallowing. The subject was placed on 10 l/minute of oxygen by face mask. EMS arrived at 13:35 and transferred the child via ambulance to the emergency department. At the time of transfer, the child was off oxygen and in no distress.   Final diagnosis: urticaria with possible angioedema.				Y					U	08/28/2009	08/28/2009	0	Physical examination	UNK	UNK	Addeeral 20 mg daily, Claritin 10 mg daily, and Flonase prn.	None	Reactive airway disease and nasal allergies			1						1	Chest pain; Dysphagia; Dyspnoea; Glossodynia; Hypoventilation; Throat tightness; Urticaria; Chest pain; Dysphagia; Dyspnoea; Glossodynia; Headache; Hypoventilation; Oxygen saturation normal; Throat tightness; Urticaria	FLU3~SANOFI PASTEUR~U3200AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U3200A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0357579	09/17/2009	VA	42.0	42		M	09/17/2009	LLL pneumonia (fever 101-102 x 3 days, started 3 days after vaccination; productive cough).  PNA diagnosed by PCP 6 days after vaccination after CXR.  Treated by pt with Aleve only, by PCP with Zithromax, Asmanex inhaler.				Y					U	09/08/2009	09/11/2009	3	CXR--LLL PNA	UNK	UNK	Diovan	none	childhood asthma			1						1	Chest X-ray abnormal; Pneumonia; Productive cough; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97843P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357582	09/17/2009	OH	62.0	62		F	09/17/2009	Pain from mid clavical to upper arm and warmth in Deltoid began 24 hours after injection, with crescendo for 24 hrs, then gradually decreased pain.  Decreased range of motion for 3 days due to pain, even passive movement was not tolerable on Day 1 of the reaction.  Temp 99.4 (oral).  Took 800 mg Ibuprofen twice daily for two days, applied ice.									Y	09/10/2009	09/11/2009	1	none	PUB	PUB		None	Hypertension			1						1	Body temperature increased; Injected limb mobility decreased; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~U3192AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357583	09/17/2009	MT	65.0	65		F	09/17/2009	Vaccine administered without any noted problems or concerns. 9/16/09 soreness noted. By 9/17/09 noted swelling ~2 diameter, redness, heat over triceps area. Noted headache 9/16/09 which has persisted and mitigated with sleep. No swelling, redness or other localized symptoms noted at flu shot site on deltoid. Did not see health care provider evaluation. Will seek care if concerns										09/15/2009	09/16/2009	1	none	PUB	PVT		none	none			1						1	Erythema; Headache; Swelling	FLU3~SANOFI PASTEUR~U3185AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~0561Y~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0357584	09/17/2009	CA	3.0	3		M	09/17/2009	Developed itchy rash all over body about 8 hours after vaccine. Responded to Benadryl. No egg or other vaccine reactions have been noted prior to this incident.									Y	08/28/2009	08/28/2009	0	None	PVT	PVT	None.	None	None			1						1	Rash generalised; Rash pruritic	FLU3~SANOFI PASTEUR~U303AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357585	09/17/2009	NY	14.0	14		M	09/17/2009	Patient developed chest tightness/pain with associated shortness of breath and bilateral lower leg numbness on 9/10/09.  Symptoms persisting but not progressing as of 9/14/09 office visit.  Good muscular strength making Guillan Barre not likely.  Being referred to Neurology for further evaluation									U	09/04/2009	09/10/2009	6	Normal chest x-ray on 9/14/09	PVT	PVT	none	no	none			1						1	Chest X-ray normal; Chest discomfort; Chest pain; Dyspnoea; Hypoaesthesia	FLU3~SANOFI PASTEUR~u 3190aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0 809y~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0357590	09/17/2009	TX	62.0	62		F	09/14/2009	Rt. eye is not clear. Suggested pt. contact physician.				Y					N	09/11/2009	09/12/2009	1		OTH	OTH		None noted	None noted			1						1	Eye disorder	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97843P2~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357591	09/17/2009	CA	67.0	67		F	09/15/2009	7-8 after receiving PNEUMOVAX, pt had rash on injection site w/c progressively increased in size prompting ER consult. Rx CEPHALEXAN and PREDNISONE.				Y					Y	09/08/2009	09/08/2009	0	None	PVT	PVT	ATENOLOL, PLAVIX, ASA	Back Pain	CAO, increased lipids			1						1	Injection site rash	FLU3~SANOFI PASTEUR~U3192AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1162X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0357593	09/17/2009	TX	65.0	65		F	09/17/2009	10:10 AM rec'd flu vac 9/1/09. 4:00 pm LA aches, pain, 8:15 pm redness, fever 101 degrees. Pain up into neck. Pt. took TYLENOL 9/16/09 then again 9/17/09 AM. 9/17/09 saw Dr. - given ZYZAL x 3 days. RTC PRN.										09/16/2009	09/16/2009	0		PVT	PVT						1						1	Erythema; Neck pain; Pain in extremity; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960313P~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357595	09/17/2009	KY	28.0	28		M	09/17/2009	Approximately 10 minutes after vaccine administered, pt felt nauseated and hot and had syncopal episode. Pt woke Up drenched in sweat.									Y	09/11/2009	09/11/2009	0		OTH	OTH	TRAZODONE	None	None			1						1	Feeling hot; Hyperhidrosis; Nausea; Syncope	FLU3~SANOFI PASTEUR~U3171AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357597	09/17/2009	LA	70.0	70		F	09/17/2009	Redness, cellulitis at site of injection starting on day of injection 9/15/09, patient given BACTRIM DS TBID X 7 days and DECADRON 1cc.				Y					Y	09/15/2009				PVT	UNK		None	PCN; Codeine; HBP; Hypothyroidism; Osteoarthritis; Arthralgia			1						1	Injection site cellulitis; Injection site erythema	FLU3~SANOFI PASTEUR~U3195AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357600	09/17/2009	MA	53.0	53		M	09/16/2009	Headache, nausea, achy, numbness in fingers, clammy.									U	09/16/2009	09/16/2009	0		OTH	UNK		Denies	Migraine headaches			1						1	Cold sweat; Headache; Hypoaesthesia; Nausea; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA447BA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0357601	09/17/2009	MA	44.0	44		F	09/17/2009	Flu vaccine received @ 10:30-within 15 minutes became itchy-rash began to developed and progressed seen in ER~12 and received IV Benadryl & Cenemet.				Y					Y	09/16/2009	09/16/2009	0	NA	UNK	UNK	Welbutrin, Singular, Prolonix, Advain, Albuterol	No/Z pac 20 URI	Asthma-allergic to lemon, garlic, gasses, mold, caused wheezes in past			1						1	Rash pruritic	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA447BA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0357602	09/17/2009	LA				F	09/17/2009	09/16/09 weak, tired, feeling cold.										09/15/2009	09/16/2009	1		OTH	UNK		None				1						1	Asthenia; Fatigue; Feeling cold	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357603	09/17/2009	WA	1.0	1	.0	F	09/17/2009	Excessive crying, irritability.  Resulted in return to MD office and referred to E.D.  Abdominal X-rays (R/O intussuscaption) and urinalysis done (R/O UTI - has hydronephrosis).				Y					Y	09/16/2009	09/16/2009	0	Abdominal X-rays (R/O intussuscaption) and urinalysis done (R/O UTI - has hydronephrosis).	PVT	UNK		None	Hydronephrosis; feeding problem.			1						1	Abdominal X-ray; Crying; Irritability; Urine analysis normal; X-ray normal	FLU3~SANOFI PASTEUR~U3174CA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0529Y~1~UN~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0976Y~1~UN~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0357604	09/17/2009	AL	50.0	50		F	09/17/2009	Redness, puffed or swollen, about size of a baseball, soreness, difficulty swallowing, glands in the neck swollen, almost Blacked out, continued dizziness, and elavated blood pressure.				Y						09/15/2009				UNK	UNK		None				1						1	Blood pressure increased; Dizziness; Dysphagia; Erythema; Lymphadenopathy; Pain; Presyncope; Swelling; Tenderness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0357605	09/17/2009	NY	37.0	37		F	09/17/2009	Numbness & tingling of hands & extremities immediately following injection. Shortness of breath shortly after but had continued to notice increased shortness of breath and then began to see bright lights intermittently.				Y					Y	09/15/2009	09/15/2009	0	None	OTH	PUB		None				1						1	Dyspnoea; Hypoaesthesia; Immediate post-injection reaction; Paraesthesia; Visual impairment	FLU3~CSL LIMITED~06549111A~1~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0357606	09/17/2009	SC	69.0	69		F	09/08/2009	Customer noticed red rash on left arm (10x7) went to clinic gave shot of DEPO-MEDROL and ZYZAL. Either allergic to flu or Pneumonia shot.				Y					Y	09/07/2009	09/07/2009	0	No other tests	OTH	OTH	See attached list	None	Since 8 years old, rhinitis			1						1	Allergy to vaccine; Rash erythematous	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0037Y~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0357607	09/17/2009	SC	7.0	7		F	09/11/2009	One day following administration of varicella vaccine a 3.n. diameter of redness + swelling was noticed by pt. on the adminis. area.  Mother of pt. took child to the ER where BENADRYL was administered.  2 days following administration of vaccine pt. presents to office with 2.25 in area of redness and swelling that is warm to the touch. Pt. states no pain.				Y					N	09/09/2009	09/10/2009	1		PUB	PUB	AMOXICILLIN;  FLONASE;  ALLEGRA	Sinus infection	Seasonal allergies			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3208AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0491Y~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0357608	09/17/2009	WI	3.0	3		M	09/19/2009	Left Parotitis.									Y	09/11/2009	09/14/2009	3	Physical exam office visits	PVT	OTH						1						1	Parotitis	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B137AA~7+~IM~RA~DTAP + IPV (KINRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500677P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~MERCK & CO. INC.~0356Y~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0862Y~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0357609	09/17/2009	AZ	60.0	60		F	09/14/2009	Received flu shot 9/10/09 @ mid morning (AM).  10:00 PM:  Itching of arms & legs -> hives, raised all over body shortly thereafter.  Heart racing.  Pulmonary doctor on call suggested 'BENADRYL'.  3 days now:  Rash almost gone.  Also seems to bother asthma.									Y	09/10/2009	09/10/2009	0		PUB	UNK	SYBICORT; PULMICORT; PROAIR for asthma; VALTREX; ZOCOR; WARFARIN; NEXIUM.		Asthma; allergies: cat; mold & dust; palo verde bloom; recently grasses.	First Time~ ()~~60.00~Patient		1						1	Asthma; Palpitations; Pruritus; Rash; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~261AA~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0357610	09/17/2009	IN	76.0	76		M	09/11/2009	Patient received shot at approximately 3pm 9/10/09 and started feeling ill in the evening. He has suffered chills and numbing of the lips, and has also felt warm or feverish & suspected allergy and prescribed Benadryl. Patient said he felt much better after a half-hour. He took one tablet. 09/11/09.									Y	09/10/2009	09/10/2009	0	N/A	OTH	PUB				same~Influenza (Seasonal) (no brand name)~UN~75.00~Patient		1						1	Chills; Hypersensitivity; Hypoaesthesia oral; Malaise; Pyrexia; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357611	09/17/2009	OH	27.0	27		F	09/11/2009	Redness. Heat radiation aft swelling of vaccination site.									Y	09/10/2009	09/10/2009	0	None	PUB	UNK	Iron/Orthotrycln	None	Anemic			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3910AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357612	09/17/2009	MI	44.0	44		F	09/13/2009	Five minutes after FLUVIRIN injection, pt felt dizziness, skin itchy and slight difficulty breathing. Pt used personal Proair HFA inhaler and felt better within 5 minutes. Pt stated completely resolved of symptoms in 2 hours.									Y	09/12/2009	09/12/2009	0	none	OTH	PVT		none	none			1						1	Dizziness; Dyspnoea; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P1~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357613	09/17/2009	NY	76.0	76		F	09/15/2009	High fever, vomiting, SPLITTING headache and slept a lot. Thank the lord.									U	08/29/2009	09/03/2009	5		UNK	UNK		Painful finger	Polymyalgia Rheumatica			1						1	Headache; Hypersomnia; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0357614	09/17/2009	MI	46.0	46		F	09/11/2009	Lt arm sore and red, firm warm area 60 mm round noted on left deltoid.  Used ice.  Advised to follow-up with PMD.									Y	09/09/2009	09/09/2009	0	None	PVT	PVT	GOLUCOPHAGE BID; SYNTHROID 125 mg daily; LOPOTOR daily.	None	Hypothyroidism; pre diabetic condition.			1						1	Induration; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~U3190AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357615	09/17/2009	DE	40.0	40		M	09/09/2009	-Bruise on left arm in area of injection -sore -Not feeling well; fever on 9/8/09									U	09/02/2009	09/05/2009	3		OTH	PVT		no	NKA/none			1						1	Injection site haematoma; Injection site pain; Malaise; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357616	09/17/2009	NJ	4.0	4		F	09/11/2009	DTaP and IPV administered in R thigh on 9-9-09 Mom noted redness, swelling and pain around injection site R thigh on 9-11-09. KEFLEX 250/5 2 tsp BID x 7 d prescribed.									Y	09/09/2009	09/11/2009	2		PVT	PVT	none.		allergy to PCN; urinary reflux.			1						1	Injection site erythema; Injection site pain; Injection site swelling	DTAP~SANOFI PASTEUR~C3157AA~5~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U3189AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~D0413~4~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~07648~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~09994~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0357617	09/17/2009	TX	48.0	48		U	09/10/2009	L arm pain & swelling following immunization from injection site to hand.  15 weeks post administration left hand continues to swell, loses grip with grasp.									N	05/28/2009	05/28/2009	0	Needle electromyography and nerve conduction studies	OTH	PVT	None Known	None	None			1						1	Electromyogram; Grip strength decreased; Injection site pain; Injection site swelling; Nerve conduction studies; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89748~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB285AB~UNK~IM~LA~HEP A (HAVRIX)~1|TD~GLAXOSMITHKLINE BIOLOGICALS~AC52B041BA~UNK~IM~RA~TD ADSORBED (DITANRIX)~1	USA		Influenza
0357618	09/17/2009	MN	17.0			F	09/08/2009	Itchy, swelling, lungs filling up, swollen feet, fever within 5 mins. Within 24 hours.				Y									No	PUB	UNK		No	Duricef			1						1	Oedema peripheral; Pruritus; Pyrexia; Respiratory tract congestion; Swelling	FLU3~SANOFI PASTEUR~U3200AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357619	09/17/2009	WV	69.0	69		F	09/10/2009	Lq. red swollen area entire upper arm with temperature of 102 F.									Y	09/08/2009	09/08/2009	0		PUB	PUB	NA	NA	NA			1						1	Body temperature increased; Injection site swelling	FLU3~SANOFI PASTEUR~U13Y4AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1435X~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357620	09/17/2009	WA	74.0	74		M	09/09/2009	Patient described extreme achiness in his muscles & joints.  Most prominent in hips and both biceps, beginning a few days after his flu shot.  No respiratory symptoms or fever.  Pain still present nearly 1 week later.									N	09/03/2009	09/06/2009	3		OTH	PVT	OMEPRAZOLE; LOVASTATIN; CILOSTAZOL; CTHYROXINE.					1						1	Arthralgia; Myalgia; Pain	FLU3~SANOFI PASTEUR~U3196AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357622	09/17/2009	DE	61.0	61		F	09/15/2009	Light headed, itchy eyes, red eyes, throat felt tight, difficulty swallowing (not severe). Seen in ED given Prednisone 60 mg po, prescribed Prednisone tapered dose and ophthalmic drops (Patenol). Benadryl 25 mg 1-2 tabs every 4-6 hrs as needed.				Y					Y	09/15/2009	09/15/2009	0	N/A	PUB	PVT	Lisinopril	N/A	N/A			1						1	Dizziness; Dysphagia; Eye pruritus; Ocular hyperaemia; Throat tightness	FLU3~PARKDALE PHARMACEUTICALS~U3205CA~2~IM~LA~INFLUENZA (SEASONAL) (FLUOGEN)~1	USA	Emergency room visit	Influenza
0357628	09/17/2009	NC	28.0	28		F	09/14/2009	Reports that within 8 hrs of receiving the FLULAVAL vaccine she developed inflammation and erythema to L upper arm, along with thoracic back spasms. She was treated by a medical provider in N Carolina with 10 day course of PREDNISONE.									Y	09/03/2009	09/03/2009	0	T-7 inflammation. CXR performed by chiropractor in N Carolina.	PVT	PVT	MVI; BENADRYL prn	None	None (kidney stone 2004)			1						1	Chest X-ray abnormal; Injection site erythema; Injection site inflammation; Muscle spasms	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFFLLA255AB~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0357629	09/17/2009	TX	74.0	74		F	09/16/2009	L mild upper arm - Red, warm, slight enduration no treatment.									U	09/14/2009	09/15/2009	1	None	PUB	PUB	Unknown	None	NKA			1						1	Injection site erythema; Injection site induration; Injection site warmth	FLU3~SANOFI PASTEUR~U3195AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0868X~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357641	09/18/2009	IN	27.0	27		F	09/14/2009	Received shot on 9-11-09 approx 11:00. At 17:00 her temp was 101.4. No sore arm at that time. By 19:00 R arm was swollen. By the next morning R arm was extremely red and tender. Swelling increased throughout Saturday 9-12-09 and fever continued throughout Saturday as well. On Sunday approx 48 hours after shot, fever returned to normal but she felt tired and slightly ill. She took BENADRYL without relief of arm pain and redness. On Monday she was seen at our Health Center around 16:00-R arm is slightly swollen in bicep area. Redness is pronounced and extends to elbow and slightly lower than elbow. R arm is still tender but improving. Redness and warmth are still present but improving. Pt had a cold on Friday 9-11-09 which started on Thursday 9-10-09. Her cold is improving with slight nasal congestion today. C/O infrequent cough.									U	09/11/2009	09/11/2009	0	None	OTH	PVT	ZYRTEC; ADVAIR; NUVARING; FLONASE	Cold for 24 hours-no fever	Hay fever, allergies, asthma			1						1	Body temperature increased; Fatigue; Injection site erythema; Injection site pain; Injection site swelling; Malaise; Oedema peripheral; Pain in extremity; Pyrexia; Skin warm	FLU3~SANOFI PASTEUR~U3173DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1384U~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357642	09/18/2009	IL	7.0	7		M	09/12/2009	Red swollen arm.									U	09/11/2009	09/11/2009	0		PVT	PVT		None	None			1						1	Erythema; Oedema peripheral	FLU3~SANOFI PASTEUR~03171BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357645	09/18/2009	FL	71.0	71		F	09/18/2009	Patient states that she was not able to form her words or speak the day after vaccination.  She states that the event eventually subsided and she did not call her doctor or wanted her doctor to be notified since she was ok.  Lasted 10 minutes.									Y	09/15/2009	09/16/2009	1	None	OTH	OTH	None	Healthy- no complaints	None			1						1	Aphasia; Speech disorder	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97843P2~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357646	09/18/2009	FM	62.0	62		F	09/17/2009	9/8 vaccinated -migraine starting about 6 hours after vaccination, low grade temperature - swollen lymph nodes under arm, neck, groin area. Terrible fatigue, whole body aches. MD prescribed antibiotic (KEFLEX) - still feeling unwell 9/17/09. Had CT on lymph nodes 9/18/09.				Y					U	09/08/2009	09/08/2009	0	CT scan on lymph nodes, 9/18/09	OTH	PVT		None	Lupus			1						1	Body temperature increased; Computerised tomogram; Fatigue; Lymphadenopathy; Malaise; Migraine; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97844P1~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357660	09/18/2009	GA	7.0	7		M	09/18/2009	Moderate/Severe swelling and redness at site. Extends to approximately 4 inch circular diameter surrounding injection site.  Painful when using. Tightness of skin.				Y					U	09/16/2009	09/16/2009	0		PVT	PVT			Asthma			1						1	Injection site erythema; Injection site pain; Injection site swelling; Skin tightness	FLU3~SANOFI PASTEUR~~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357661	09/18/2009	FL	54.0	53		F	09/18/2009	24 hours after receiving my vaccination, I started breaking out in hives around my neck, shoulders and a couple on my right hand (shot was administrated in my right arm); condition is worse on 2nd day.  Taking 50mg of Benadryl and applying 1% hydrocortisone cream. Walgreens has been notified that I am filing this report.									N	09/16/2008	09/17/2008	1		UNK	PVT		none	none	none~ ()~NULL~~In Patient		1						1	Urticaria; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~0508862-07344~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97844PI~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0357662	09/18/2009	GA	65.0	65		F	09/18/2009	On 9-17-2009 patient called me to report injection site causing discomfort and pain in her (L) shoulder. Stated, I feel the injection was given too high. Client is using a heating pad and taking pain medication with no improvement. Small bruise at site per client. Client to come to clinic this afternoon for site inspection. Client in clinic at 4:15 p.m. and site inspected by myself and another RN. Small bruise located in (L) far upper arm, slightly posterior. Bruise not located on deltoid muscle. Site not red, warm to touch or excessively swollen at this time, but is painful to touch with only a small amount of swelling. No knot at injection site. Pictures taken with client's signed consent. Client states that site is so painful that she is staying awake at night. Wants pain to stop. Client referred to urgent care for evaluation. District notified and urgent care called to report referral/problem. If injection site is the area where small bruise is located, injection was given too high. Checking to see if injection needs to be repeated (question absorption at current site). 9-18-2009 phone call to client at 7:45 a.m. to determine if any treatment was recommended and to determine if client was feeling better. No answer, client was to call me today when she had her planning period.									Y	09/09/2009	09/10/2009	1		UNK	UNK	Unknown	None	PCN			1						1	Injection site discomfort; Injection site haematoma; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3199AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357663	09/18/2009	TX	59.0	59		F	09/18/2009	Reddness at site on right arm, down to midarm. Site swollen, red, hard warm to touch for 2 days. Symptoms decreasing on the third day.									Y	09/16/2009	09/16/2009	0		MIL	PVT	lipitor 40mg, synthroid 112mcg. arimadex 1mg, menmtex 1 mg.	no				1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth	DTAP~SANOFI PASTEUR~c3247AA~UNK~IM~RA~DTAP (DAPTACEL)~1|FLU3~CSL LIMITED~05749111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~734AA~UNK~IM~LA~HEP B (ENGERIX-B)~1	USA		Influenza
0357664	09/18/2009	FL	64.0	64		F	09/18/2009	shot hurt more than usual shotsSOB x 1 1/2 days HA, muscle aches, swelling and redness at site x 3 days									Y	09/05/2009	09/05/2009	0		UNK	UNK	lisinopril, lasix, protonix, potassium	not reported	tylenol,cephalosporins and prilosec			1						1	Dyspnoea; Headache; Injection site erythema; Injection site pain; Injection site swelling; Myalgia	FLU3~SANOFI PASTEUR~U3204AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357665	09/18/2009	FL	74.0	64		M	09/18/2009	hurt more at onset; SOB, muscle aches, HA lasting 1 1/2 days; swelling and redness at site lasting 3days									Y	09/05/2009	09/05/2009	0		UNK	UNK	denied	not reported	denied			1						1	Dyspnoea; Headache; Injection site erythema; Injection site swelling; Myalgia; Pain	FLU3~SANOFI PASTEUR~U3204AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357666	09/18/2009	NY	3.0	3		M	09/18/2009	Pt. presented 24hrs post immunization with an approx. 6cm in diameter red, blotchy urtsicarial region surrounding area of admin. in L thigh. Raisedm warm and itchy. No systemic reaction noted.				Y					Y	09/16/2009	09/17/2009	1		PVT	PVT						1						1	Injection site erythema; Injection site pruritus; Injection site urticaria; Injection site warmth	FLU3~SANOFI PASTEUR~U3203AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357667	09/18/2009	MI	47.0	47		F	09/18/2009	Skin rash with some itching appeared on hands, arms, and legs (about 25-30 raised bumps).  Noticed this two days after Flu shot.									U	09/14/2009	09/16/2009	2		UNK	UNK	Unknown	Denies	Denies			1						1	Pruritus; Rash	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0357668	09/18/2009	WI	7.0	7		F	09/18/2009	MOTHER CALLED THIS AM TO REPORT THAT LAST EVENING CHILD'S LIPS AND LEFT SIDE OF FACE STARTED TO SWELL.  THE LEFT DELTOID WHERE INJECTION WAS GIVEN BECAME VERY HARD AND RED.  MOTHER ADMINISTERED 3 TSP OF BENADRYL OTC AND CALLED THE ER.  THEY ADVISED MONITORING AND CALLING MD OFFICE IN AM.  THIS AM LIP AND FACE STILL SWOLLEN AND INJECTION SITE STILL RED AND HARD.  MORE BENADRYL WAS ADMINISTERED THIS AM.  WRITER ADVISED MOTHER TO CONTACT MD'S OFFICE TO SEEK ADVICE ON FURTHER TREATMENT									Y	09/17/2009	09/17/2009	0		PUB	PUB	UNKNOWN	NONE	UNKNOWN			1						1	Injection site erythema; Injection site induration; Lip swelling; Swelling face	FLU3~SANOFI PASTEUR~U3208AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357671	09/18/2009	MN	68.0	63		F	09/18/2009	Itching, slight rash, and facial flushing approximately 4 hours after influenza vaccine received.  She took po Benadryl which provided some relief of itching.									Y	09/17/2009	09/17/2009	0		PUB	UNK						1						1	Flushing; Pruritus; Rash	FLU3~SANOFI PASTEUR~U3191AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357673	09/18/2009	MN	23.0	23		F	09/18/2009	Itching, hives, headache, sore throat, nasal stuffiness after receiving LAIV.  She took some Benadryl.  Hives are gone, but itching still present as of 9/18/09 at 10am.									U	09/17/2009	09/17/2009	0		PUB	UNK						1						1	Headache; Nasal congestion; Oropharyngeal pain; Pruritus; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500713P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0357675	09/18/2009	NV	29.0	29		F	09/18/2009	2330, 16 Sep 09.  Pt states the left side of her face was numb, drooping, and drooling.  It resolve spontaneously by 0530 on 17 Sep 09.									Y	09/16/2009	09/16/2009	0	None	MIL	MIL	Acetozolamide	None	Migraines	none~ ()~NULL~~In Patient		1						1	Drooling; Facial palsy; Hypoaesthesia facial	FLUN3~MEDIMMUNE VACCINES, INC.~500679P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0357676	09/18/2009	FL	48.0	48		F	09/18/2009	Pain and swelling to left deltoid area. Left upper arm tricep/bicep area with redness and swelling.  Spoke with patient today she states that her arm is better and pain has stopped.Pt. evaluated at urgent care center she states she was prescribed doxyclycline and naprosyn.				Y					Y	09/14/2009	09/15/2009	1		UNK	UNK						1						1	Erythema; Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U3204AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1435X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0357677	09/18/2009	TX		53		F	09/18/2009	PATIENT STATES INSIDE ARM AND COLLAR BONE AREA INFLAMMED AND REAL SORE. RECIEVED FLUVIRIN AND PNEUMOCOCCAL VACCINE IN SAME ARM. PATIENT STATES SHE IS FINE JUST REAL SORE									Y	09/16/2009	09/17/2009	1		UNK	UNK						1						1	Inflammation; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0626Y~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357678	09/18/2009	IL	57.0	57		M	09/18/2009	I recieved the Flu shot on 15 Sep 2009.  Ibegan breaking out with a severe rash all over my body.,  This first began to appear on September 17th,...Went to see my doctor on September 18th for treatment.				Y					Y	09/15/2009	09/17/2009	2		UNK	UNK		None	None			1						1	Rash generalised	FLUX~UNKNOWN MANUFACTURER~~2~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|UNK~UNKNOWN MANUFACTURER~~UNK~UN~UN~VACCINE NOT SPECIFIED (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0357680	09/18/2009	WA	58.0	58		F	09/18/2009	During 6 hours following vaccination upper left arm became increasingly sore and headache developed.  This was followed by chills, intense nausea and periodic vomiting over a 5 hour period.  18 hours after vaccination patient  recovered but with lingering mild headache.   Note: Patient experienced no adverse reaction to previous seasonal flu shots received in 2006, 2007, and 2008.									Y	09/17/2009	09/17/2009	0	None	UNK	UNK	Vitamin D3 (1000IU/daily)	None	None			1						1	Chills; Headache; Nausea; No reaction on previous exposure to drug; Pain in extremity; Vomiting	FLU3~SANOFI PASTEUR~49281-0384-15~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357681	09/18/2009	WI	45.0	45		F	09/18/2009	HIVES NEAR LEFT ELBOW 45 MINUTES AFTER RECEIVING VACCINATION.									Y	09/14/2009	09/14/2009	0		PUB	PVT		NONE				1						1	Urticaria	FLU3~SANOFI PASTEUR~U3204AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357683	09/18/2009	AZ	36.0	36		F	09/10/2009	Pt states when vaccine was injected she experienced dizziness metallic taste in mouth H.A. mid on forehead - States was also seen black spots in eyes. Lt eye blood shot which wasn't present prior to injection. Pt observed for 30 minutes. Symp. decreased except metallic taste. Pt will notify PCP and F/u as needed. Also will have someone taken her home.									U	09/10/2009	09/10/2009	0	BP, 120/70; Fingerstik BS, 133	OTH	PVT	BICITRA; LIPITOR; LEXAPRO; PROTONIX	Diabetic - no other illness	Diabetes; K+ low; High cholesterol			1						1	Blood glucose increased; Dizziness; Dysgeusia; Headache; Ocular hyperaemia; Visual impairment	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960313P~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357684	09/18/2009	AZ	46.0	46		F	09/18/2009	Flat erythematous - hive like - area distal to injection site - (2 cm lower) area is sl warm to touch - approx 6 cm X 3 cm - Otherwise no other untoward effects.									Y	09/17/2009	09/18/2009	1	None	PUB	OTH		Otitis externa				1						1	Injection site erythema; Injection site urticaria; Injection site warmth	FLU3~SANOFI PASTEUR~U3211AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357686	09/18/2009	OR	1.08	1	.1	F	09/15/2009	Febrile seizure 9 hours p shots.				Y					Y	09/09/2009				PVT	UNK						1						1	Febrile convulsion	FLU3~SANOFI PASTEUR~UT3171DA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0215Y~1~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~D92436~4~IM~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0847Y~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0357687	09/18/2009	NY	3.0	3		M	09/18/2009	Localized vesicular rash/eruption at vaccine injection site, calamine lotion topically, no further treatment warranted.									Y	09/16/2009	09/18/2009	2	None	PVT	UNK		None	None	None~ ()~~0.00~Patient		1						1	Injection site rash; Injection site vesicles	FLU3~SANOFI PASTEUR~U3205CA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357688	09/18/2009	NM	50.0	50		F	09/18/2009	Patient felt lighthead and needed to sit down. Paramedics called, patient evaluated.									Y	09/18/2009	09/18/2009	0		OTH	OTH		None	None			1						1	Dizziness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357690	09/18/2009	GA	46.0	46		F	09/18/2009	Pt noticed increasing redness and swelling on R arm beginning 9-17-09. Warm to touch. Mild soreness noted.				Y					Y	09/16/2009	09/17/2009	1		PUB	PVT						1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3192AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357692	09/18/2009	PA	1.02	1	.0	M	09/18/2009	Lump & redness at HIB vaccine site of flu vaccine site.				Y					U	09/16/2009	09/17/2009	1	NA	PVT	PVT		NA	NA			1						1	Injection site erythema; Injection site mass	FLU3~SANOFI PASTEUR~UT3171DA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UFG99AA~4~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~D81705~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0357694	09/18/2009	VA	29.0	29		F	09/18/2009	Enlarging red, tender area around injection site. Pain up to shoulder, symptoms first noted 9/16/09.									U	09/15/2009	09/16/2009	1		PVT	UNK	Allegra-D 12, Desogen. Phentermine, Topamax, Vitamin B-12, Zolpidem Tartratc					1						1	Injection site erythema; Injection site pain; Pain in extremity	FLU3~SANOFI PASTEUR~U3190AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357695	09/18/2009	KS	19.0	19		M	09/18/2009	Injected Novartis FLUVIRIN vaccine (UT97840P1, exp 5/10) in Rt arm. Pt immediately complained of dizziness, then dry throat and cold feeling/tingling in extremities. BP was 159/99, then 145/89. Dizziness got worse. Gave pt 25 mg BENADRYL PO and called EMS. Pt never lost consciousness but dizziness worsened. EMS transported to hospital.				Y					U	09/18/2009	09/18/2009	0		UNK	UNK						1						1	Dizziness; Dry throat; Paraesthesia; Peripheral coldness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357696	09/18/2009	MN	57.0	57		F	09/17/2009	Small ruptured capillary immediately after injection. Seen by Dr. He said blood pressure was fine, no issues breathing. Patient told him she has issues with platelets. He said just small hematoma from injection.				Y					Y	09/17/2009	09/17/2009	0		PVT	UNK		None noted	Unknown to provider			1						1	Capillary disorder; Haematoma; Immediate post-injection reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357697	09/18/2009	MA	1.11	1	.1	F	09/18/2009	Diffuse mildly raised erythematous papules with clear halo surrounding them.									U	09/14/2009	09/15/2009	1	Allergen for clam, egg white, cod fish, corn, milk, peanut, shrimp, soybean, walnut, wheat, scallop, sesame seed, and strawberry-all undetectable.	PVT	PUB	None	None	None			1						1	Allergy test negative; Rash erythematous; Rash papular	FLU3~SANOFI PASTEUR~U31670A~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357701	09/18/2009	MN	4.0	4		F	09/18/2009	Hives				Y					Y	09/16/2009	09/18/2009	2		PVT	PVT			Asthma			1						1	Urticaria	FLU3~SANOFI PASTEUR~U3201AA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0469Y~1~IM~LL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0357702	09/18/2009	TN	62.0	62		F	09/18/2009	Uniformly erythemic, pruritic, round and oval plaques,lesions approximately 4 inches x 3 inches appeared on inside of upper right arm extending from below right armpit to 1 inch from right elbow.									Y	09/17/2009	09/17/2009	0		UNK	UNK	Atrovent 0.6% Nasal Spray, Estring Vag., Flector Top., Hydroxychloroquine Oral, Lisinopril-HCTZ 10 mg-12.5 mg., Pantoprazole oral, Ranitidine HCL Oral, Restasis 0.05% eye dropperette, Simvastatin oral, Sulfazine EC oral, Zolpidem oral.	None	HTN, Hypercholesterolemia	None~ ()~NULL~~In Patient		1						1	Erythema; Rash pruritic; Skin lesion	FLU3~SANOFI PASTEUR~U3191AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357703	09/18/2009	NY	18.0	18		F	09/18/2009	Received the vaccine at 12, about 15 minutes after the injection began to have itching eyes, face hot, bil ear pain and throat and chest tightness									Y	09/18/2009	09/18/2009	0	VS 2 HOURS AFTER Incident: O2 sat 100%, peak flows 350 and 400. BP 120/70 heart rate 70.At the time of evaluation, the only symptom left was face felt hot, cheeks were red. Zyrtec given with po benadryl to take later if needed.	PUB	PUB	Lialda and birth control pills	None	Ulcerative colitis			1						1	Blood pressure normal; Chest discomfort; Ear pain; Erythema; Eye pruritus; Heart rate normal; Oxygen saturation normal; Peak expiratory flow rate; Skin warm; Throat tightness	FLU3~SANOFI PASTEUR~U3205CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357708	09/18/2009	TX		32		F	09/18/2009	Adverse reaction occured at about 1:30 pm. Pt felt light headed, experienced pain on both sides of abdomen, and began experiencing trouble breathing. I then administerd 50mg of diphenhydramine IM. 911 was called and was taken to coryell memorial hospital. After diphenhydramine was given, trouble breathing subsided but patient still felt faint and cold.				Y					U	09/18/2009	09/18/2009	0		UNK	PVT	diphenhydramine 50mg/ml					1						1	Abdominal pain; Dizziness; Dyspnoea; Feeling cold	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960316p~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1161x~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0357709	09/18/2009	AZ	64.0	64		F	09/18/2009	Lt upper arm above elbow to below elbow volar red tender and warm to touch.										09/15/2009	09/16/2009	1		PUB	PUB	MultiVitamins, Fish Oil 500 mg cap, ASA 81 mg tab delayed release, Vit. D_1000 Max St 185-1000 mg unit tab	none	none			1						1	Erythema; Pain of skin; Skin warm	FLU3~CSL LIMITED~06549111a~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357710	09/18/2009	WI	59.0	59		F	09/18/2009	Three hours after receiving immunization started to have body aches and chills, Temp rose to 101 F, developed profound sense of exhaustion and drowsiness.  Had immediate tingling down entire arm, questions whether injection may have gone IV versus IM  Area at injection site caused no symptoms, no hardness, inflammation, or heat									Y	09/16/2009	09/16/2009	0	No tests	PUB	PVT	None	None	No			1						1	Body temperature increased; Chills; Fatigue; Immediate post-injection reaction; Pain; Paraesthesia; Somnolence	FLU3~SANOFI PASTEUR~U3211AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357712	09/18/2009	AZ	80.0	80		F	09/18/2009	9/16/09 1630 patient was in her usual state of health when she received the flu vaccine from the Clinic located inside a supermarket.  Approximately 30 minutes later she began complaining of nausea and that she felt clammy.  An RN then called 911.  EMS arrived at the scene at 1536, patient was found lying on floor on left side complaining of severe nausea and dry heaves.  Vital Signs taken by EMS, HR=80, skin was pale, temp=95.8 F, glucose=179, SaO2=98% on room air.  Patient was transported to Emergency Room.  At 1610 patient arrived in ER and was complaining of back pain and abdominal pain.  By 1735 the patient had developed persistent hypotension requiring pressors for blood pressure support.  She went into respiratory failure requiring intubation, and developed metablic acidosis.  As of 9/18/09 @1500 the patient has been weaned from all pressors. Medical Records and Discharge Summary received 10/12/09.  Date of Admission:9/16/09-9/29/09.  Primary Diagnoses:  Anaphylactic shock secondary to flu shot.  Acute respiratory failure secondary to shock on admission.  Hypokalemia.  Hypomagnesemia.  Acute renal failure. Dehydration.  Malnutrition. Anemia. Assessment:  Patient was admitted to ED 30 minutes after receiving a flu shot c/o abdominal and back pain 9/10, and nausea.  In the ED she was found to be hypotensive and required triple pressors.  BP 84/48, systolics in the 60's, 70's, 80's. Her temperature was 92.7.  Patient was somewhat somnolent, but responsive to verbal commands.  Admitted to the ICU for stabilization.  Patient was transfused 2 units of packed red blood cells.  The patient went into respiratory failure requiring ventilator support secondary to shock. While on the ventilator, the patient was sedated. Pt. noted to be weak and hypocalcemic, she was given 1 gram of calcium IV, hypomagnesemia also present as well as thrombocytopenia.  She had severe metabolic lactic acidosis and profound acidemia and was on a bicarb drip being hyperventilated.  As BP normalized, she was weaned off two pressors.  Urinary output was decreased, but improved.  A central venous line was placed. Noted to have moderate cardiomegaly.  Pulmonary critical care, cardiology and nephrology consults were obtained.  In the ICU patient received supportive care including vent support, pressors and electrolytes as well as IV antibiotics.  As her condition stabilized, the patient was extubated, was doing much better and became stable.  Patient was discharged to a skilled nursing facility for further care.			Y		Y	14			U	09/16/2009	09/16/2009	0	10/12/09-records received-Labs and Diagnostics: CT of Chest-no PE, Hgb 8.3 (L), Hct 26.2 (L).  WBC 12.6 (H), 17.0 (H), 16.8 (H), 16.0(H), RDW 17.2(H), 16.8(H), 16.7 (H), 16.8 (H), Lymphocytes 14.4 (L), 14.4 (L), 15.6 (L), PLT 98 (L), 80 (L), 75 (L), 88 (L).  Neutorphils 87.9 (H), 89.2 (H), 92.3 (H), 90.8 (H), BUN 33 (H), 38 (H), 41 (H), 45 (H), creatnine 2.6 (H), 1.2 (H), 1.3 (H) 1.4 (H), AST 2535 (H), ALT 1553 (H).  ABG pH 7.08(L), CO2 31(L), bicarb 9 (L).  ABG pH 7.32 (L), CO2 32(L), bicarb 17(L). TSH 12.04 (H), PT 17.6 (H), 18.3 (H), 19.2 (H), 19.8 (H), 20.2 (H). PTT 43 (H), 40 (H). CT of chest and abdomen-Abnormal.  Chest X-ray showed 2.8 cm upper lobe pulmonary nodule.  Echocardiogram-Abnormal. Urinalysis protein 2+, UA blood 3+, UA RBC 11.5 (H), UA Mucous present (H). Calcium 8.3 (L), 6.8 (L), 7.5 (L). Magnesium level 1.7 (L), Glucose 178 (H). 146 (H), 176 (H) 215 (H), 238 (H), Amalyase 19 (L), T. Protein 5.6 (L). Labs and diagnostics on 9/29/09:  BP 152/93, Temp. 97.1, O2 saturation 99%, WBC 10.2(WNL), Hgb 14.3 (WNL), Hct 44.6 (WNL), PT 17.6 (H), INR  1.8(L), BUN 33 (H).	UNK	UNK	Home medications include lasix, avapro and vitamin b	Reported that patient was in her usual state of health	Past Medical History: Hypertension, CHF, asthma, atrial fibrillation, and kidney stones. Allergies include sulfa. 10/12/09-records received-PMH: Obesity, hypertension, congestive heart failure, asthma, permanent pacemaker, appendectomy, cholecystectomy, hysterectomy, kidney stones, atrial fibrillation, 1 pack per day for 10 years smoking history, history of binge drinking. DVT of Left foot.  Allergic to sulfa.			1						1	Abdominal pain; Back pain; Blood glucose increased; Cold sweat; Endotracheal intubation; Hypotension; Metabolic acidosis; Nausea; Oxygen saturation normal; Pallor; Respiratory failure; Retching; Hypotension; Malaise; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P1~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P1~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Life Threatening,Hospitalisation	Influenza
0357716	09/18/2009	VA	32.0	32		F	09/18/2009	Received vaccine 9/1/09 at 6:44pm.  Symptoms began 9/2 at 8:00am and I still have them.   Periods of severe vertigo where entire room is spinning.  Between episodes of vertigo I am constantly dizzy.  Severe nausea, have not eaten a normal meal since vaccination.  Severe ear pain, occasionally hear a high pitch tone, when I hear the tone the pain becomes so severe I almost feel as though I will convulse (I have NO history of seizures).  Hard to walk straight.  Extreme fatigue.  Difficulty thinking and formulating thoughts/sentences.  Vision blurry periodically.  Periods of intense sweating and I normally never sweat, even after a long workout at the gym, and when I have these sweating spells I do not have a fever, I always take out a thermometer and check.  My heart rate periodically will rise very high (as high as 140 BPM), this happens daily, and I know I am giving an accurate heart rate reading because I am checking it on a fingertip pulse/oximeter.  My mouth, tongue, cheeks, and lips frequently go completely numb.  All of this has completely disabled me, I have been unable to do anything, it is a struggle to just to make my be and to shower.  I went to the ER on 9/2 and the doctor basically just ascertained that nothing life threatening was going on and advised me to follow up with my Primary Care Physician.  I saw my PCP 9/4 and he was not sure what it was, thought it perhaps was some sort of weird allergic reaction, so he prescribed the Medrol dosepak which did not help.  I saw a neurologist 9/8 and he did not know what it was either and requested that my PCP prescribe some Otic-Edge drops for my ears and some Phenergan for the nausea.  My neurologist did a full exam and ordered blood work.  I see him again in about 3 weeks.  My neurologist also referred me to a neuro-otologist.  My PCP called in the ear drops and Phenergan for me and neither helped.  I tried Meclizine and that did not help.  I saw a neuro-otologist this past Tuesday (9/15) and he said it might be Labrynthitis, but he was not sure as he had not seen a reaction like this before.  He prescribed the Trans-dermal Scopolamine patch to see if it would help to get more food in me as I have lost about 10 pounds since receiving the vaccine because I have been too nauseated to eat.  They have helped a little.  I have a follow up with the neuro-otologist on 9/22.  These symptoms have completed disabled me and I know it is from the flu vaccine because I had none of these symptoms prior to receiving the vaccine.  I have spent a lot of money on the ER visit, doctors visits, and prescriptions and I still am confined to the couch.  I am afraid to drive because I never know when a vertigo attack will hit me and even when I don't have the vertigo, I am so dizzy and fatigued.  This has completely taken over my life and not knowing for certain what it is, I have no idea how long it will last, if and when I will feel better, and my worst fear is that it will get worse than it already is.				Y					N	09/01/2009	09/02/2009	1	CMP, CBCw/Diff, Strep test, Sed rate-Westergren, EKG, Chest X-ray,  Full exam by PCP (including eyes and ears), Full neurological exam(by neurologist), Full neruo-otology exam	UNK	PVT	Nexium 40mg, Allegra 180, Flonase 2 sprays each nostril, Symbicort 160/4.5 2 inhalations in am and pm, Remeron 37.5, Topamax 75mg, Amitiza 24mcg 3x daily, Deplin 7.5mg, Diazepam 5mg 2x daily	None	Asthma, Allergic Rhinitis, GERD, Migraines, Slow intestinal motility			1						1	Activities of daily living impaired; Chest X-ray; Differential white blood cell count; Dizziness; Ear pain; Eating disorder; Electrocardiogram; Fatigue; Full blood count; Gait disturbance; Heart rate increased; Hyperhidrosis; Hypoaesthesia facial; Hypoaesthesia oral; Mental impairment; Nausea; Neurological examination; Red blood cell sedimentation rate; Streptococcal identification test; Tinnitus; Vertigo; Vision blurred; Weight decreased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357726	09/18/2009	IL	66.0	66		F	09/18/2009	Patient's right upper arm became very sore later that evening and then became red, hot and swollen. The entire upper arm was swollen. She also experienced chills and a low grade fever. Two days later, she still has a red band around her upper right arm. No treament-advised to see MD.									N	09/16/2009	09/16/2009	0		OTH	PUB	PREMARIN		None	Swelling, redness, pain~Tetanus Toxoid (no brand name)~1~0.00~Patient		1						1	Chills; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Oedema peripheral; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P1~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1161X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357727	09/18/2009	CA	14.0	14		F	09/18/2009	My daughter had the flu shot given to her on 9-16-09 at 4:45 pm, she had severe pain in the arm and at 8:00 pm she developed a low grade 100.3 fever. She also had a headache nasal congestion and a cough. In the morning of 9-17 she still had a low grade fever but in the evening the fever went up to 101.3-(ear thermometer									U	09/16/2009	09/16/2009	0	On 9-19-09 I spoke to health professional and gave her the feedback re my daughters condition.	PVT	PVT	None	None	None	fever~DTP (no brand name)~1~0.00~Patient		1						1	Cough; Headache; Nasal congestion; Pain in extremity; Pyrexia	FLUX~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0357728	09/18/2009	MA	36.0	36		M	09/18/2009	Joint pain. Bilat. upper extremity weakness, achiness all over (muscle). 9/15/09 T 101-102 degrees F, tightness in throat. 9/16 MD visit decreased joint pain, increased lack of dexterity esp side rec'd injection, left side. Advised by MD to take ibuprofen.				Y					U	09/14/2009	09/14/2009	0	Cursory neuro exam by MD and bloodwork on 9/17/09. Referred to neurologist.	OTH	PVT	None	None	Seasonal allergies			1						1	Arthralgia; Blood test; Body temperature increased; Motor dysfunction; Muscular weakness; Myalgia; Neurological examination; Pain; Throat tightness	FLU3~SANOFI PASTEUR~960302P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357740	09/18/2009	AR	33.0	33		F		Pt got vaccine after lunch. Since she received the injection she felt bad. Swelling of her tongue, tenderness in neck. Took BENADRYL then came to ER. Received SOLUMEDROL 125 mg IM.				Y					Y	09/17/2009	09/17/2009	0	None	PVT	PVT		None	None			1						1	Feeling abnormal; Myalgia; Swollen tongue	FLU3~SANOFI PASTEUR~U3204AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357741	09/18/2009	NH	32.0	32		F	09/16/2009	Hives all over body, neck and face, itching.				Y					Y	09/16/2009	09/16/2009	0		PVT	PVT	PREDNISONE 40 mg; PENTESA		CROHN'S disease			1						1	Pruritus generalised; Urticaria	FLU3~SANOFI PASTEUR~U3213AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357742	09/18/2009	KS	43.0	43		F	09/17/2009	9/14/09 after shot arm pain. 24 hours fever, body aches. 72 hours still fever, arm red, welts, warm to touch. This arm received PNEUMOVAX.				Y					Y	09/14/2009	09/14/2009	0	CMP, UA, CBC, underlying UTI	PVT	PVT		None	Anal CA-3 months since last chemo			1						1	Erythema; Full blood count; Metabolic function test; Pain; Pain in extremity; Pyrexia; Skin warm; Urinary tract infection; Urine analysis; Urticaria	FLU3~SANOFI PASTEUR~U3202AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0981X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0357863	09/18/2009	UT	45.0	45		M	09/18/2009	Left arm sore. By 9pm felt nauseated, both shoulders and upper arm began to hurt as the night progressed pain moved down his back and hips. Nausea continued next day woke up by 6am walked only a bit but still felt nauseated, chills no fever, still feels malaise right now. Took Advil PM for symptoms. Spoke to doctor on 9/18 10:30 am who recommended also to use Ibuprofen. He doesn't feel like eating, getting better with medication not if it wears off. Lying around not moving much. Doctor recommended also water and benadryl. Not red on injectetion site, indicated that left arm was more painful than right.									U	09/17/2009	09/17/2009	0		PVT	PVT	Lamotrigine 200, budeprion_SR, paroxetine, fluticasone propionate nasal spray, multivitamin, iron.	No	Seasonal allergies, depression.			1						1	Arthralgia; Back pain; Chills; Decreased appetite; Malaise; Musculoskeletal pain; Nausea; Pain in extremity	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TDAP~UNKNOWN MANUFACTURER~~1~UN~LA~TDAP (NO BRAND NAME)~1	USA		Influenza
0357717	09/19/2009	IL	27.0	27		M	09/19/2009	I was having shortness of breath, weak, dizzy, and felt like passing out and vomiting. My hands became tingly and sweaty, I was taken to the emergency room.				Y					Y	09/16/2009	09/17/2009	1		UNK	UNK	Ativan, Proventil, Claritin, Aciphex, Metamucil, & Probiotic.	N/A	I have no known allergies to Medications, but have seasonal allergies. Three years ago I was diagnosed with anxiety. I have grown up with asthma.			1						1	Asthenia; Dizziness; Dyspnoea; Hyperhidrosis; Paraesthesia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0357721	09/19/2009	AZ	57.0	57		M	09/19/2009	Asthma exacerbation: wheezing, difficulty breathing. Epinephrine (1:1000 1 mg/ml) 0.5 mg sq given, 8 mg Decadron IM, albuterol/atrovent respiratory treatment and ambulance transfer to closest hospital				Y					U	09/19/2009	09/19/2009	0	unknown	UNK	PVT	prednisone, ipatropium, diltia, singular, metformin, advair, bupropian SR, lorazepam, lexapro, gabapentin, HCTZ	none	DM, Asthma, HTN, SMI/depression, ADHD, tremors			1						1	Asthma; Dyspnoea; Wheezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~96031 3P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357658	09/20/2009	AZ	6.0	6		M	09/20/2009	(L) arm erythematous, hot, edematous from shoulder to elbow. (+) nausea and low grade fever.									U	09/19/2009	09/19/2009	0		OTH	PVT	SINGULAIR; BENADRYL; Albuterol	None	Asthma; Seasonal allergies			1						1	Injection site erythema; Injection site oedema; Injection site warmth; Nausea; Pyrexia	FLU3~SANOFI PASTEUR~U3216AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357724	09/20/2009	ID	59.0	59		F	09/20/2009	Unexplained body itching, progressed to hives and low grade temp (100.3) over a period of approx 10 hours.  Took 2 over the counter Benedryl for the hives and 2 ibuprophen for the temp.									Y	09/17/2009	09/18/2009	1	none	UNK	PVT	none	none	none			1						1	Body temperature increased; Pruritus generalised; Urticaria	FLU3~SANOFI PASTEUR~49281-0384-15~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357725	09/20/2009	IL	42.0	42		F	09/20/2009	On 5/19/09 when making a follow-up call to patient, the patient reported: Approx. 6 hours after receiving vaccine,  she felt bronchitis-type symptoms: hoarse throat, cough. About 6 hours after this she experienced generalized itchiness and has had worse sleep quality at night since then. No medical attention sought. Has taken benadryl with some relief of itching, but voice is still quite hoarse. Felt a little better 9/19/09 than during the previous day. Called pt. today at 9:07 a.m., she stated she feels a little better than she did yesterday. Voice is clearer than yesterday.									N	09/17/2009	09/17/2009	0	None	UNK	UNK	Lasix, Potassium, Spironolactone, Trazodone, Xanax	Left ear felt  plugged up, with decreased hearing in this ear.	Bipolar Disorder, Anxiety Disorder, Sleep Disorder (has very little REM time)			1						1	Cough; Dysphonia; Poor quality sleep; Pruritus generalised	FLU3~SANOFI PASTEUR~03191AA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357729	09/20/2009	IN	2.0	2	.7	F	09/20/2009	ABOUT FORTY HOURS AFTER THE SHOT SHE DEVELOPED A FEVER THAT LAST ABOUT THREE HOURS<  SHE THEN DEVELOPED A SPOTTY RASH THAT STARTED ON HER FACE>SHE STILL HAS THE RASH ALL OVER HER FACE AND BODY> NOW FIVE DAYS AFTER THE SHOT SHE DEVELOPED A TERRIBLE HEADACHE>SHE HAS NEVER EVER COMPLAINED OF A HEADACHE BEFORE>MOTRIN HELPED WITH THE FEVER AND HEADACHE>BENADRYL DID NOT RESOLVE THE RASH									U	09/14/2009	09/16/2009	2		PVT	PVT		none	none			1						1	Headache; Pyrexia; Rash; Rash generalised	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0357730	09/20/2009	GA	49.0	49		F	09/20/2009	After receiving the flu vaccine at work, I started coughing about 2 hrs afterward. At approximately 6 hrs after the vaccine my left hand and especially my left thumb started aching badly and the strength in my left hand, left thumb and left fingers was diminished. This symptom has continued ever since the day of the vaccination with no improvement. I reported this to my supervisor on the morning after the vaccine and was instructed to see the POC. I went to the area where I received the vaccine and the POC was not available so I was instructed to speak with someone else. After describing my symptoms to her, she stated it was not related to the vaccine and if I had further problems or questions I should consult my physician. I attempted to work for approximately one hour but was in too much pain to perform my job so I went home on sick leave. I saw a physician that afternoon and he stated the pain and symptoms could be related to the injection if it had hit a nerve. He stated it could take several weeks or longer for the pain and strength to return if in fact a nerve was damaged. I am in pain and cannot use my left hand fully due to the diminished strength and pain. I plan to make an appointment with a specialist/orthopedist as soon as possible.									N	09/17/2009	09/17/2009	0		MIL	UNK	Adderall XR 30 mg once a day	headache	allergic to cephalosporins			1						1	Cough; Grip strength decreased; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~?~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0357731	09/20/2009	MI	57.0	57		F	09/20/2009	I received a flu vaccination around 10:00Am on Thursday 17 September  by 4:30 PM I was experiencing dizziness and muscle aches.  By 6:00 pm I was experiencing a high fever and sore throat.  The next day I was extremely fatigued and had hives on my upper body these were most prevelant on my face, and chest.  I took theraflu on Thursday night and Friday afternoon.  My symptoms lasted through Saturday morning.									Y	09/17/2009	09/17/2009	0		UNK	UNK	none	none	none			1						1	Dizziness; Fatigue; Myalgia; Oropharyngeal pain; Pyrexia; Urticaria	FLUX~SANOFI PASTEUR~u3210AA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0357732	09/20/2009	MT	37.0	37		M	09/20/2009	Had influenza vaccine approx 1:30 pm.  About thre hours later, eyes began to swell, red and itching.  Approx 1/2 hr later lungs felt congested, face flushed, bottom lip swelling.  Muschle ache/pain and fever followed.  He took his regular nebulizer albuterol that he has for asthma, dayquil									Y	09/18/2009	09/18/2009	0		PUB	PUB	Vit E, Fish oil, Flax oil, Garlic, B complex	none	asthma			1						1	Eye pruritus; Eye swelling; Flushing; Lip swelling; Myalgia; Ocular hyperaemia; Pulmonary congestion; Pyrexia; Eye pruritus; Eye swelling; Flushing; Lip swelling; Myalgia; Ocular hyperaemia; Pulmonary congestion; Pyrexia	FLU3~SANOFI PASTEUR~U3194AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U3194A~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0357733	09/20/2009	MT	61.0	61		M	09/20/2009	had flu shot at 6pm.  10 pm felt throat itchy & woke up at midnight with swollen lower lip & tongue, some wheezing and loose BM. Took two motrin.  Some difficulty swallowing.  Went to local emergency room, given Benadryl 50 mg. IM and Zyrtec 10 mg po.  Dx angioedema after flu vaccine.  Observed for two hours.  No wheezing, itchy throat upon discharge.  Swollen lip continued till next day.  Sent home with medrol dose pack (6 days) XYZZL 5 mg.  No symptoms as of this writing except feeling tired.				Y					Y	09/16/2009	09/16/2009	0		PUB	PUB	blood pressure medication	none	none			1						1	Angioedema; Diarrhoea; Dysphagia; Lip swelling; Swollen tongue; Throat irritation; Wheezing; Angioedema; Diarrhoea; Dysphagia; Fatigue; Lip swelling; Swollen tongue; Throat irritation; Wheezing	FLU3~SANOFI PASTEUR~U3194AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U3194A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0357734	09/20/2009	WA	40.0	40		F	09/20/2009	Extreme pain at injection site, unable to move arm. Extreme flu like symptoms, all muscles in pain, migraine that won't go away, chills, vomiting, fever 104, unable to get up from bed two days so far, unable to sleep due to symptoms, all over weakness, racing heartbeat, sweating, dehydration.									U	09/18/2009	09/18/2009	0	Still sick, spoke with a doctor and a nurse. No one knows what to do. Keep telling me to take tylonol. I don't think they understand how bad this is. I have NEVER had the flu this bad. We did not receive any paperwork. I do not know what lot number	PVT	UNK		no	latex,clindamycin			1						1	Asthenia; Chills; Dehydration; Heart rate increased; Hyperhidrosis; Influenza like illness; Injected limb mobility decreased; Injection site pain; Migraine; Mobility decreased; Myalgia; Pyrexia; Sleep disorder; Vomiting	FLU3~CSL LIMITED~unk~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~UNKNOWN MANUFACTURER~unk~5~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0357735	09/20/2009	AK	8.0	8		F	09/20/2009	Flumist vaccine was given intranasally to apparently healthy child on 8.17.09.  Approximately 48 hours later, developed fever, sore throat, nasal congestion and cough.  Admitted 72 hours later with diagnosis of right lower lobe pneumonia with hypoxemia, leukocytosis, and elevated CRP.  This happened today, so I do not have the outcome.  I do not think this event is related to the immunization, but thought it should be reported anyway.  11/17/09 medical records received for DOS 9/20/09 Final DX: R lower lobe pneumonia, hypoxemia Three days S/P flumist C/O sore throat, fever.  HA, nasal. l cong. Cough. exposed to strep A. Breathing diff in PMD office.  Tachypnea, tachycardia. R LL consolidation. Prob bacterial. Hypotension r/o hypovolemia. D/C to home. ICD9 Codes: 786.9, 486.					Y				U	09/17/2009	09/19/2009	2	RLL consolidation on chest X-ray. Negative EIA for group A step and influenza A and B.  Elevated neutrophil count and CRP.  Cultures (viral and bacterial) are pending.  Labs & Diags: WBC 13.9 (H), CXR -R LL consolidating. possible pleural effusion.	UNK	UNK	Mefloquine given one dose 250 mg, 3/4 tablet around the time of symptom onset.	None known	None known PMH: non febrile seizure  Allergies: NKA			1						1	Bacterial culture; C-reactive protein increased; Chest X-ray abnormal; Cough; Hypoxia; Influenza serology negative; Leukocytosis; Lobar pneumonia; Nasal congestion; Neutrophil count increased; Oropharyngeal pain; Pyrexia; Streptococcal identification test negative; Virus culture	FLUN3~MEDIMMUNE VACCINES, INC.~500691P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TYP~BERNA BIOTECH, LTD.~3001537~1~PO~MO~TYPHOID LIVE ORAL TY21A (VIVOTIF)~1	USA	Hospitalisation	Influenza
0357736	09/20/2009	MA	9.0	9		M	09/20/2009	Patient was administered LAIV even though patient was contraindicated due to aspirin therapy.  LAIV administered on 09/17/2009; on 09/20/2009, at 7AM, patient complained of severe throbbing headache and belly was jumpy. Patient transported to Medical Center.  Blood sample and urine sample, CT Scan.  Possible MRI tomorrow, because of brain surgery that occured approximately 4 years ago (due to moyamoya disease).  Patient presented with nasal congestion, headache and jumpy belly.				Y					Y	09/17/2009	09/20/2009	3	Waiting to speak with pediatric neurologist on 09/21/2009.	UNK	UNK	Trileptol, children's aspirin	No	moyamoya disease; operated on (piel synagosis) Dec, 2005.	see above~ ()~~0.00~Patient		1						1	Abdominal discomfort; Blood test; Computerised tomogram; Headache; Nasal congestion; Urine analysis; Computerised tomogram abnormal; Contraindication to vaccination; Headache	FLUN3~MEDIMMUNE VACCINES, INC.~~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500675P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Emergency room visit	Influenza
0357738	09/20/2009	NH	70.0	70		M	09/20/2009	Onset of symptoms within a few hours: aches, chills, fever (to 103F), foggy thought processes (trouble articulating thoughts), flushed face, minor cough with wheeziness.				Y					U	09/20/2009	09/20/2009	0	Taken to Hospital for treatment. Given Tamaflu.	UNK	UNK	unknown (daughter filling this form out)	none				1						1	Chills; Cough; Feeling abnormal; Flushing; Pain; Pyrexia; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0357739	09/20/2009	TX	39.0	39		F	09/21/2009	Itchy rash across chest.									U	09/19/2009	09/20/2009	1		UNK	PVT	None	None	celiac			1						1	Rash pruritic	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0332308	09/21/2009	OR	10.0	10		M	09/17/2009	Ongoing tonic-clonic seizures for several hours.					Y	1			Y	11/06/2008	11/10/2008	4	EEGs - mild nonspecific abnormalities	OTH	PUB	none	none	None; never had a seizure before			1						2	Electroencephalogram abnormal; Grand mal convulsion	FLUN3~MEDIMMUNE VACCINES, INC.~500546P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Hospitalisation	Influenza
0357659	09/21/2009	MN				F	09/19/2009	Patient had swelling and itching at site of injection. Parent reported no breathing problems and was told to apply a cold compress to site.									Y	09/19/2009	09/19/2009	0		OTH	OTH	Vitamin-D; Advair	None	None			1						1	Injection site pruritus; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357661	09/21/2009	FL	54.0	54		F	09/18/2009	Patient stated she broke out in hives 24hrs after receiving flu shot. She has been taking Benadryl 50mg every 4 hours and apply Hydrocortisone cream .									Y	09/16/2009	09/17/2009	1		OTH	PVT		Nothing	Unknown Medical conditions / NKDA			1						2	Urticaria; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~0508862-07344~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97844PI~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0357682	09/21/2009	WI	55.0	55		M	09/20/2009	Swelling at the injection site.									U	09/20/2009	09/20/2009	0		OTH	PVT		No				1						1	Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357691	09/21/2009	CO	19.0	19		F	09/18/2009	Patient became light headed, dizzy, pale and complained of trouble breathing, 911 was called and EMT's arrived. Symptoms resolved and patient did not require hospitalization.									Y	09/18/2009	09/18/2009	0	None	OTH	PVT			Downs Syndrome; Pulmonary Hypertension			1						1	Dizziness; Dyspnoea; Pallor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97A3492~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357758	09/21/2009	WI	16.0	16		F	09/15/2009	None										09/15/2009				PVT	PVT		none				1						1	Inappropriate schedule of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA259~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0357759	09/21/2009	MA	59.0	59		M	09/15/2009	Patient complained of tingling in left arm, spreading to side of body. Lips maybe felt funny.				Y					Y	09/15/2009	09/15/2009	0		OTH	PVT						1						1	Feeling abnormal; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357761	09/21/2009	NJ	36.0	36		F	09/11/2009	Reports left pupil dilated 60 after injection.  Went to ophth - resolved with PILOCORPINE & sent to ED for neuro work up CT, CTA work up was inconclusive.				Y					Y	09/04/2009	09/04/2009	0	CT & CTA	PUB	UNK		No				1						1	Angiogram; Computerised tomogram; Mydriasis	FLU3~CSL LIMITED~06449111A~UNK~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0357764	09/21/2009	VA	9.0	9		M	09/18/2009	9/1/09 - Left arm red, hot, tender no increase in size on 9/2/09.  Rx: ORAPRED, BENADRYL, cool compresses.  Rev 9/3/09 - Resolving local Rxn .				Y					Y	09/01/2009	09/02/2009	1		PVT	PVT		None	Had egg allergy as infant, ok'd by allergist.  Eats eggs.			1						1	Erythema; Local reaction; Skin warm; Tenderness	FLU3~SANOFI PASTEUR~U3204AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357778	09/21/2009	MI	70.0	70		F	09/21/2009	sore throat, headache, fever, body aches, cough									Y	09/14/2009	09/17/2009	3		UNK	UNK						1						1	Cough; Headache; Oropharyngeal pain; Pain; Pyrexia	FLU3~CSL LIMITED~~UNK~~~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357781	09/21/2009	KS	9.0	9		F	09/21/2009	Pt received influenza vaccination at 8:30 a.m. Pt developed a red, raised area the size of a nickel at the injection site by 1:00 p.m.  By the next day, the area was as large as a baseball and warm to touch.  Mother applied Triamcinolone Ace Tonide Ointment 1% to the injection site.  Area is less reddened 48 hours after injection.									Y	09/19/2009	09/19/2009	0	None	PUB	PUB	Focalin XR caplets 20 mg daily, Flintstone multivitamin daily	None	asthma	redness at injection site~Influenza (Seasonal) (no brand name)~1~8.70~In Patient		1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3192AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357786	09/21/2009	SC	32.0	32		F	09/21/2009	Acute anaphylactic reaction approx. 2-3 minutes after injection. Airway began to swell with difficulty in breathing.  Heart beat tachycardic in the 160's with BP of 117/90. Epipen administered EMS called.  Oxygen placed on and I.V. Benadryl 50 mg. given.  Transported to E.R.. Hands and fingers began to draw from hyperventilating and unable to visualize or open eyes. I.V. Solu-Medrol given in E.R. along with Zantac.  Finally became alert and orientated.  Reaction lasted about 90-120 min.				Y					Y	09/17/2009	09/17/2009	0		PVT	UNK						1						1	Anaphylactic reaction; Dyspnoea; Hyperventilation; Pharyngeal oedema; Tachycardia; Visual impairment	FLU3~CSL LIMITED~0644911A~UNK~IM~~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0357790	09/21/2009	WA	58.0	58		M	09/21/2009	Torso and upper extremity urticaria, lower extremity vasculitis.  Pt to see internist for labs this week.									U	09/15/2009	09/16/2009	1	UA and CMP pending	PVT	PVT	Diovan, HCTZ	none	Hypertension			1						1	Metabolic function test; Urine analysis; Urticaria; Vasculitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97847P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357793	09/21/2009	TX	90.0	90		M	09/21/2009	Within days of receiving Fluvirin patient experienced sore arms, difficulty raising arms and bruising. He received a fluvirin injection in each arm in error.  His right arm had bruising to the elbow, across the shoulder and under the collar bone.  His left arm is bruised several inches around the injection site. The patient take warfarin. He went to Dr. and the doctor took him off the warfarin.				Y					N	09/12/2009	09/12/2009	0	patient went to Dr. on 9-16-09 and had INR done.	UNK	UNK	boniva 150mg, Warfarin 2mg, amlodipine5mg, lisinopril 40mg					1						1	Contusion; Incorrect dose administered; Injected limb mobility decreased; Injection site haematoma; International normalised ratio; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P2~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357796	09/21/2009	MD	56.0	55		F	09/21/2009	Injection site reaction (70mm X 40mm of induration). Characterized by local errythma and moderate puritis - resolved in 10 days with OTC topical medication.									Y	09/03/2009	09/03/2009	0	None	MIL	MIL	Singular, Flonase, Lisinopril, Simvastatin, Meloxican.	None	Allergic rhinitis, hypertension, hyperlipidemia.                                                                  Med allergies to penicillin,sulfa drugs, and codeine.			1						1	Injection site erythema; Injection site induration; Injection site pruritus	FLU3~CSL LIMITED~01749211a~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357799	09/21/2009	NC	90.0	90		F	09/21/2009	We gave her the flu vaccine at 9:10am then about 10 minutes later she was having nausea and dizziness. She said she hadn't eaten anything before showing up for her shot. We got her a Sprite and sat next to her for the next 20 minutes. She started experiencing chest pain then EMS was called and took her away about 9:30.				Y					U	09/21/2009	09/21/2009	0		PUB	PVT	Digoxin 0.125mg, Pravastatin 40mg, Spironolactone 25mg, Klor-con 8 mEq, Maxitrol 1% opth suspension, Imdur 60mg	No	Congestive Heart Failure, Hypertension			1						1	Chest pain; Dizziness; Nausea	FLU3~SANOFI PASTEUR~u3192aa~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357803	09/21/2009	IL	60.0	60		F	09/21/2009	red, pustular skin rash treated with Cephalaxin 500mg BID x 7d and Valtrex 1GM BID x 5d									U	09/14/2009	09/17/2009	3		PVT	UNK	Zoloft, Crestor, Levoxyl	none	NKDA; Hypercholesterolemia, Hypothyroidism, Anxiety, GERD			1						1	Rash; Rash erythematous; Rash pustular	FLU3~SANOFI PASTEUR~U3194AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~0722Y~1~IM~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0357804	09/21/2009	CA	41.0			U	09/21/2009	left arm muscle ache, muscle pain, runny nose, left arm weakness									U		09/15/2009			PUB	UNK						1						1	Muscular weakness; Myalgia; Rhinorrhoea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0357806	09/21/2009	OR	35.0	35		F	09/21/2009	The flu shot was administered via injection into left upper arm. Immediately my face began to burn my ears turned bright red, I got dizzy and sick to my stomach. They advised me to sit down for a while (5 minutes) and then sent me home. I continued to have these symptoms for several days. However The ER refused to see me. Now it is on my allergy list......				Y					Y	10/15/2008	10/15/2008	0		MIL	MIL		none	GERD, abdominal migranes, chronic pain, peripheral nervous system disorder, anemia, type 2 diabetes, poly cystic ovarian disease			1						1	Abdominal discomfort; Dizziness; Erythema; Skin burning sensation	FLUX~SANOFI PASTEUR~unknown~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0357807	09/21/2009	CA	53.0	53		F	09/21/2009	Within 24 hours of the vaccination, I noticed hives on the inside of both of my thighs. I had the vaccine on 9/18 and today is 9/21 and the hives are still the same. The hives are not that itchy so I am just leaving them alone and hope they will go away soon.									N	09/18/2009	09/18/2009	0		UNK	UNK	NONE	NONE				1						1	Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0357810	09/21/2009	CA	50.0	50		U	09/21/2009	tingling in back of throat, tightening of chest									U	09/21/2009	09/21/2009	0		PUB	UNK						1						1	Chest discomfort; Paraesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0357811	09/21/2009	CA	55.0	45		U	09/21/2009	chest tightening									U	09/21/2009	09/21/2009	0		PUB	UNK						1						1	Chest discomfort	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0357812	09/21/2009	OR	62.0	62		M	09/21/2009	patient states in just a few minutes he began to have muscle and joint pain throughout his body. Within approx 20 minutes he felt extreme muscle pain and feverish for approx. 3-4 hours and then symptoms began to subside.  He stated he felt better the next day.  He does have fibromyalgia and said he is never completely free from discomfort, but had never felt like this.  He did not take any medications to relieve the pain or fever because he was afraid he would mask his symptoms.  He did take his regular medications at 9:00 pm.  Patient is from Oregon and just visiting in Montana until end of September.									Y	09/16/2009	09/16/2009	0		PUB	PUB	Vicodin, takes at bedtime; Zoloft at bedtime, Warfarin, takes at bedtime	none	fibromyalgia, sleep apnea			1						1	Arthralgia; Feeling hot; Myalgia	FLU3~SANOFI PASTEUR~U3194AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357813	09/21/2009	CA	55.0	55		F	09/21/2009	Approximately one hour after receiving vaccine started to feel short of breath, flushing of skin, throat tightness, non-productive cough, wheeze. Self administered Azmacort inhaler, Albuterol inhaler and took Benadry 25 mg by mouth. Coughing and wheezing persisted taken to ER, given Albuterol nebulizer, Ipratropium nebulizer, Prednisone 40 mg orally. Patient reported a history of multiple allergies-PCN, Demerol, IVP dye, Pentothol, Motrin, Sulfa, Cephalosporin, Metabusulfite, Tetanus vaccine. Reportedly carries epi pen for allergies but did not administer to self.				Y					U	09/21/2009	09/21/2009	0		PUB	UNK	unknown	No	High cholesterol, Asthma, GERD, Hiatal Hernia			1						1	Allergy to vaccine; Contrast media allergy; Cough; Drug hypersensitivity; Dyspnoea; Flushing; Multiple allergies; Throat tightness; Wheezing	FLU3~CSL LIMITED~06649111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0357815	09/21/2009	FL	41.0	41		F	09/21/2009	flu-like sy's: sore  throat, achy, runny nose x 2 days									Y	09/19/2009	09/20/2009	1	none	UNK	UNK	estrace, synthroid, ditropan	no	hypothyroid			1						1	Influenza like illness; Oropharyngeal pain; Pain; Rhinorrhoea	FLU3~SANOFI PASTEUR~U3204AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357816	09/21/2009	MO				F	09/21/2009	Patient recieved flu shot at approximately 6am on 9/15/09.  Approximately 2-3 hours later (per the patient) both arms became red and blotchy from elbow to wrist only.  Itch got progressively worse as day went on.  Patient washed with soap and water and covered with hydrocortisone cream.  At approximately 2pm patient visited with nurse who came in to administer flu shots for afternoon group.  Nurse verified that patient did have red, blotchy skin and some discoloration but patient reported that itchiness was gone by 2pm.  I spoke with patient on 9/16/09 and she stated that all discoloration was gone as well as itchy sensation.									Y	09/15/2009	09/15/2009	0	NA	UNK	UNK	None	None	None that were noted on consent form.			1						1	Erythema; Pruritus; Rash macular; Skin discolouration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~96031~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357817	09/21/2009	PA	24.0	24		M	09/21/2009	Numbness on patient's right half of tongue, inability to close patient's right eye, limited facial movements on patient's right side of face.  Tongue numbness began 3 days after vaccination, with rest of symptoms occurring suddenly 36 hours later.  Preliminary diagnosis of Bell's palsy.  Perscribed Prednisone and Valtrex.									U	09/16/2009	09/19/2009	3	CBC, HIV, Lyme Disease - Results pending.	PVT	UNK	Zyrtec, sertraline, Vitamin D, Spiriva, Singulair	No known illness	No known allergies			1						1	Borrelia burgdorferi serology; Facial palsy; Full blood count; HIV test; Hypoaesthesia oral	FLUX~SANOFI PASTEUR~Unknown~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0357818	09/21/2009	NC	66.0	66		F	09/21/2009	Hives on legs about 5 hours after the vaccine was given.  Lasted approximately 24 hours.  Took Benedryl for 24 hours.									Y	09/17/2009	09/17/2009	0		UNK	UNK		None	ANAPHACTIC REACTION TO HYALURONATE  INJECTION TO KNEE.  SYNVISC .                  SEASONAL ALLERGIES ONLY			1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~66521-0112-10~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357819	09/21/2009	FL	28.0	28		F	09/21/2009	Symptoms: patient complain of soreness of the right arm around the injection site: noted redness and 5 whelts ; Treatment: warm compressors to the  left arm with the redness and Benadryl.									Y	09/19/2009	09/21/2009	2		UNK	UNK		none	Asthma			1						1	Injection site erythema; Injection site pain; Urticaria	FLU3~SANOFI PASTEUR~U3263AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0632Y~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357820	09/21/2009	CO	38.0	38		F	09/21/2009	Both me and my step-daughter (age 13) experienced hearing loss within 1 hour in one ear after the 2009 seasonal flu shot. The sensation seemed to travel from the arm to the ears. This lasted for 2-3 days. (Husband, 14 year old female and 5 year old male didn't have this reaction)									Y	09/17/2009	09/17/2009	0		PUB	PVT	None	None	None			1						1	Deafness	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0357821	09/21/2009	TX	63.0	63		M	09/21/2009	HIVES,  ITCHING ON THE BACK, BACK OF ARMS, UPPER CHEST, AND SHOULDERS.  MOSTLY ON THE BACK.  BEGAN APPROX 6 HRS AFTER THE INJECTION.  HAVE APPLIED BENEDRYL (EXTRA STRENGTH) THROUGHOUT THE DAY APPROX EVERY 3-4 HOURS FOR SOME TEMPORARY RELIEF									U	09/19/2009	09/19/2009	0		UNK	PVT	HCTZ, CRESTOR, TOPROL,  LOTREL	NONE	HYPERTENSION, CHOLESTEROL - 109			1						1	Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~66521-0112-10~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357822	09/21/2009	CA	49.0	49		M	09/21/2009	Fever, generalized pain, nausea, disturbed sleep: onset 4 hours after vaccine. Diarrhea following day. Severe generalized rash: 3 days after vaccine  Treatment with epi, benedryl, and solumedrol				Y					Y	09/16/2009	09/16/2009	0	Unknown: in hospital emergency department	UNK	PUB	Fluconazole, Voltaren, Nexium	Lyme's disease	Hepatitis C: viral load at 0 for 10 yrs, no active treatment			1						1	Diarrhoea; Nausea; Pain; Pyrexia; Rash generalised; Sleep disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA68BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0357823	09/21/2009	WA	29.0	29		F	09/21/2009	significant pain at the site of injection. Started 12 h after admin. Still present 5 days later. Full ROM which has improved. Awaiting CPK isoenzymes. Administered at a different clinic. We are dealing w/ the side effect.									U	09/16/2009			CPK isoenzymes	PVT	UNK	Levothyroxine, BCP		sulfa, nasocort			1						1	Blood creatine phosphokinase; Injection site pain	FLUX~UNKNOWN MANUFACTURER~Other clinic~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0357825	09/21/2009	OR	70.0	70		F	09/21/2009	The patient was given a dose of the Zostavax vaccine in the left arm.  At the same time, she received Pneumovax in the same arm, and Fluzone in the other arm.  She experienced severe rash and itching at Zostavax site for seven days, with lump in muscle.  Nine days after administration, she discovered swelling in lymph system on left side of the body from the rib area under the arm up to the neck, above the clavicle.  She experienced fatigue and shortness of breath.  On-call doctor advised a trip to Urgent Care facility on the night of ninth day.  There, X-rays were taken and patient was advised to return the following day.  Upon return another physician requested blood work.  Results of both X-rays and blood work were normal.  The next day, patient saw her family physician, who questioned a possible diagnosis of lymphoma (a possibility, according to the second physician in Urgent Care), and indicated the likely cause was the Shingles vaccine.  At this time, swelling remains, but has subsided to a small degree.				Y					U	09/10/2009	09/19/2009	9	X-rays and blood work	UNK	PVT			Seasonal allergic rhinitis                                            Allergic response to Zithromax                             Extreme response to small-pox vaccination at age 7			1						1	Blood test; Dyspnoea; Fatigue; Injection site pruritus; Injection site rash; Laboratory test normal; Lymphadenopathy; X-ray normal	FLU3~SANOFI PASTEUR~U3198AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0982X~1~IM~LA~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~1730X~1~ID~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0357831	09/21/2009	FL	23.0	23		F	09/21/2009	This case was reported by a healthcare professional and described the occurrence of anaphylaxis in a 23-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medications included ACCUTANE. On 17 September 2009 at 15:00, the subject received a dose of FLUARIX (.5 ml, unknown, left arm). On 17 September 2009, 30 minutes after vaccination with FLUARIX, the subject experienced anaphylaxis, tachycardia, tremor, vomiting and absent pulse. At one point she had no pulse. The subject was given epinephrine and taken to the emergency room. The healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). The subject was treated with EPINEPHRINE. At the time of reporting the outcome of the events were unspecified. The healthcare professional considered the events were probably related to vaccination with FLUARIX.			Y	Y				Y	U	09/17/2009	09/17/2009	0	UNK	OTH	PVT	Isotretinoin	Unknown	The subject had previously received influenza vaccinations.		A0808086A	1						1	Anaphylactic reaction; Pulse absent; Tachycardia; Tremor; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA447BA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Life Threatening,Disabling	Influenza
0357833	09/21/2009	CA	66.0	66		F	09/16/2009	Red, swollen about 4-5 inches below injection site. Fever 100 degrees C for 1 day. Problems mainly arm; unable to lift. MD prescribed BACTRIM and BENADRYL. Required IV antibiotics, 4 days hospitalization. Area swollen from shoulder to elbow; now recovered.   10/22/09:  Hospital Medical Records and Discharge Summary received for dates of service 9/17/09 to 9/20/09.  Dx:  Severe allergic reaction pneumococcal vaccination, Cellulitis of the right arm complicating vaccination injection, hypertension, Assessment:  Presented with swelling, warmth, erythema and spreading lymphangitis up the arm.  She also developed swelling and erythema in the face. BP 189/92.  Rehydrated and treated with antibiotic therapy, prednisone as well as antihistamine medication.  Discharged dramatically improved.  To follow up with allergy specialist.    ICD Codes:  72981, 99939, 6823, V854, E9488, E8490, 27800, 4019, 3384, 56409.				Y	Y	4			Y	09/15/2009	09/15/2009	0	10/22/09:  Hospital Medical Records and Discharge Summary received for dates of service 9/17/09 to 9/20/09.  Labs and diagnostics:  WBC 6 (NL), hematicrit 36.5 (NL), hemoglobin 12.6, platelets 235 (NL), creatnine 0.8 (NL), CO2 32 (NL) chloride 101(NL), BUN 22 (NL). Urinalysis WNL.	OTH	PUB		None	Allergy, PCN; Tetracycline. 10/22/09:  Hospital Medical Records and Discharge Summary received for dates of service 9/17/09 to 9/20/09.  PMH:  chronic pain syndrome, obesity, allergy to penicillin and tetracycline.	swollen arm at injection site~Pneumo (no brand name)~1~61.00~Patient		1						1	Erythema; Injected limb mobility decreased; Pyrexia; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0627Y~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0357834	09/21/2009	GA	55.0	55		F	09/21/2009	4 hours after vaccination she was not lucid and spiked a high fever.  Admitted to hospital.  White blood count 0.  Liver function affected.  Diagnosis an inflammatory reaction to flu shot.  10-27-2009  Medical records, discharge summary and ICD9 coding received for DOS 9/16-9/18. FINAL DX:  Pancytopenia, transaminitis, coronary artery disease, hypokalemia, probable severe reaction to the influenza vaccination. Patient presented in ED with fever of 102, hallucinations. Was concurrently being treated for UTI and had seen PCP same day.  Received flu vaccine. 3-4 hours later developed chills, fever hallucinations and delusions. Also reported nausea. Treated empirically for urosepsis. C/O frequency, urgency and dysuria.  Subsequently developed pancytopenia and transaminitis. Pancytopenia improving. Transaminitis resolving. Hypokalemia resolved. Discharged to home with planned follow-up. ICD Codes: 809, 780.97, 284.89, 599, 995, 276.8, 414.01, 250, 401.9, 272.4, E949.6, 790.6.					Y	4			Y	09/15/2009	09/15/2009	0	Not available . LABS & DIAGS: CXR - subtle opacity, concerning for pneumonia, KUB-normal. WBC 4.2 (L), HGB 11 (L), PLATELETS 100,000 (L),  GLUCOSE 122 (H), LACTIC ACID 25.5 (H),  alt 274 (H), AST 187 (H), TOTAL BILI 1.6 (H), K 3.5 (L), Viral titers all neg.	OTH	PVT	Not available		PMH: DM II diet controlled, coronary artery disease, cardiac catheterization,  stent, hypertension, dyslipidemia, cholecystectomy, hysterectomy, lysis of adhesions, tubal ligation. Fatty infiltration of liver. ALLERGIES: Penicillin			1						1	Feeling abnormal; Inflammation; Liver disorder; Pyrexia; White blood cell count decreased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0357836	09/21/2009	IL	67.0	67		F	09/22/2009	24 hours after vaccine administration patient was seen in urgent care w/Dx of arm pain, and referred to or the further evaluation. Patient complained of pain, limited range of motion to Left arm.				Y					U	09/10/2009	09/12/2009	2	729.5 Arm Pain	OTH	UNK		None	None			1						1	Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U3214AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357837	09/21/2009	OR	37.0	37		F	09/21/2009	My left arm hurts from shoulder to wrist.									U	09/21/2009	09/21/2009	0		OTH	UNK		No	No			1						1	Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA259AA~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0357838	09/21/2009	LA	51.0	51		F	09/21/2009	One minute after receiving vaccine pt. claim to feel sick in stomach, started to breath heavily then became dosing off and not responsive. Gave 0.3mg epipen.				Y					Y	09/21/2009	09/21/2009	0		OTH	OTH						1						1	Abdominal discomfort; Hyperventilation; Malaise; Unresponsive to stimuli	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357839	09/21/2009	AZ	80.0	80		M	09/18/2009	Flu like symptoms, chest congestion									Y	09/17/2009	09/18/2009	1	None	PVT	UNK		None				1						1	Influenza like illness; Pulmonary congestion	FLU3~SANOFI PASTEUR~U318944~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357840	09/21/2009	IL	32.0	32		F	09/21/2009	Shortness of breath, lightheadedness, chills, later tingling of fingers, hands, arms, and tingling on legs from knees down. Patient went to ER, vital signs normal. Patient given CLARITIN tablet at 5:30pm.				Y					Y	09/19/2009	09/19/2009	0	None	OTH	PVT	None	None	None			1						1	Chills; Dizziness; Dyspnoea; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357841	09/21/2009	IA	6.0	6		F	09/21/2009	Urticaria tx with Celadrin 4mg, antihistamine and Orapred.				Y					U	09/17/2009	09/20/2009	3	None	PVT	PVT		None	Zithromax - Rash		IA090022	1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500711P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0357842	09/21/2009	FL	71.0	71		F	09/21/2009	Patient states she had a rash 2 days after vaccination lasting 2 days. She reportedly applied a cold compress to alleviate the itching. The raised rash around stomach. She said looked like hives.									Y	09/14/2009	09/16/2009	2	None	OTH	UNK		None	None			1						1	Pruritus; Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97843P2~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357844	09/21/2009	NM	28.0	28		F	09/21/2009	Pt stated a couple of hour after receiving the shot she experienced pain. Each day it has increased. Now at 10 days. She fells it under her arm - travelling up her neck. Per pt it has increased more every day. Daughter had one same day and was fine.										09/11/2009	09/11/2009	0		UNK	UNK		Fine (None)	None			1						1	Axillary pain; Neck pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357848	09/21/2009	KY	21.0	21		M	09/21/2009	Pt complained of dizziness, light headiness, became pale, sweaty, fainting hot 15 minutes after vaccine administered. 9/21/09 pt placed in supine position with feet elevated, cold packs applied, 6.75 FL. oz juices given P.O. Pt. recovered in approximately 10 minutes. Vital signs BP 144/82 Hr 76, resp 28, 2nd vitals 141/80, Hr 69, HXG; Resp 24.									Y	09/21/2009	09/21/2009	0		OTH	PVT	None	None	PNC; Codeine; Keflex			1						1	Dizziness; Heart rate normal; Hyperhidrosis; Pallor; Respiratory rate increased; Syncope	FLU3~CSL LIMITED~07849111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357849	09/21/2009	CA	60.0	60		F	09/20/2009	Patient experienced lightheadedness and decrease in blood pressure (76/53) after vaccination with FLUVIRIN.				Y					Y	09/20/2009	09/20/2009	0		OTH	PVT	Multivitamin OTC	None	Allergy to:  ERYTHROMYCIN & SULFAS (per patient)			1						1	Blood pressure decreased; Dizziness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848P1C~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357850	09/21/2009	WA	3.0	3		F	10/06/2009	Swollen red hot left arm where flu shot was given (from shoulder almost to elbow). Swollen red (L) arm. Rx. cold compress - No BENADRYL.				Y					N	09/16/2009	09/17/2009	1	None	PVT	PUB	None  KEFLEX 250 mg TID X 7-10 days	None	None			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3204AA~5~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357853	09/21/2009	FL	81.0	81		M	09/20/2009	Itching+ red blotches on arms + legs on Thurs.  afternoon.  Patient was at the beach earlier in the day.  Small, red bumps on the arms + legs.  Patient took CHLORTRIMETON and it has resolved.									Y	09/16/2009	09/17/2009	1		OTH	OTH		None	Sulfa drugs.			1						1	Pruritus; Rash erythematous; Rash macular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~9784482~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357854	09/21/2009	FL	67.0	67		F	09/20/2009	Itching and bright red blotches on both arms + legs starting Friday morning.  Has not fully resolved yet as of Sunday afternoon.  Patient was in the sun at the beach Wednesday afternoon.  She has been taking CHLORTRIMETON and is better.									N	09/16/2009				OTH	OTH			AVELOX;  Parkinson's disease			1						1	Pruritus; Rash erythematous; Rash macular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97844P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357855	09/21/2009	CA	49.0	49		F	09/18/2009	12:20pm 9/18/09 patient returned to pharmacy to report deltoid muscle pain after 9/4/09 has not diminished. Hurts to move right arm especially painful taking off putting on sweaters.									U	09/04/2009	09/05/2009	1		UNK	UNK		None	None			1						1	Myalgia; Pain in extremity	FLU3~SANOFI PASTEUR~U9130AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357856	09/21/2009	MN	53.0			F	09/21/2009	Patient contacted clinic the 17th stating she developed small hives and redness and itching 2 1/2 hrs after vaccine given. Stated she applied HC cream.									Y	09/16/2009	09/16/2009	0	none	PVT	PVT	none	no	EES; Cepradine; Rynatar, allergies			1						1	Erythema; Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA458AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0357859	09/21/2009	MA	3.0	3		M		Approx. 1 hour after receiving vaccine, mom noted patient to be unresponsive in back seat of car. Patient's eyes rolled back in head, tongue was hanging out, drooling and mumbling. Symptoms were resolved by the time patient got to ER. Developed croupy cough that night and fever the next am.				Y					Y	09/19/2009	09/19/2009	0	None	UNK	PUB	none	none				1						1	Cough; Drooling; Gaze palsy; Protrusion tongue; Pyrexia; Unresponsive to stimuli	FLU3~SANOFI PASTEUR~U3188AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357860	09/21/2009	MO	6.0	6		M	09/18/2009	13 x 13cm erythema left upper arm.				Y					Y	09/16/2009	09/18/2009	2		PVT	PVT	FLOVENT MDI	No	ASD - closed 8/05			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U3171AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357861	09/21/2009	MO	4.0	4		M	09/18/2009	9X9 cm care of erythema mild warmth and mild TTP to left upper deltoid.				Y					Y	09/15/2009	09/17/2009	2	None	PVT	PVT	Flovent MDI	No	None			1						1	Injection site erythema; Injection site pain; Injection site warmth	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B116BA~5~IM~LA~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~U3171AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0765Y~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~08794~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0357862	09/21/2009	TN	9.0	9		M	09/21/2009	Approximate 30 hours after vaccination Pt. had rash which progressed to hives - 48 hrs after vaccination seen in ED and placed on  ATARAX nd Prednisone. Has hid.				Y					U	09/16/2009	09/17/2009	1		PVT	PVT	KEPPRA	None	Seizure disorder (benign Rolandic Epilepsy)			1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~U3202AA~7+~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357867	09/21/2009	IA	87.0	87		F	09/22/2009	9-21-09 Mon AM. Daughter called VNA office stating her mother was having reaction @ the site of flu shot given on Fri, Sept 18. Having egg size area of redness and swelling, warm to touch and painful to touch.									Y	09/18/2009	09/18/2009	0		OTH	UNK			CHF; High BP; Kidney disease; Allergy: Atenolol; Lopressor			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3208AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357868	09/21/2009	CO	65.0	65		F	09/21/2009	On 9/18/09 around dinner time, patient's L arm appeared as a small red area at injection site and was tender and a bit swollen.  On 9/19/2009 patient noticed a big lump high on her left shoulder above the inj site area.  Her arm was red from elbow up to her neck, was extremely hot and looked like it had been burned.  Patient called pharmacy on that day 9/19/09 to report reaction & RPN on duty consulted patient to watch closely and if no improvement contact MD.  Patient also took her temperature on 9/19/09 and said it was normal.  On 9/20/09 the lump on the shoulder area appeared smaller, but the swelling seemed increased from the elbow to shoulder.  It felt warm and tight.  On 09/21/09 patient stated she still had some redness and puffiness, but not swollen as it had been.  she feels that it is definitely getting better and feels much better.  Pharmacist had spoke with patient around 4:00 pm on 9/21/09 when this was last reported.									U	09/18/2009	09/18/2009	0		OTH	OTH	Unknown	None	Unknown			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling; Injection site warmth; Mass	FLU3~SANOFI PASTEUR~U3185AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1167X~1~IM~LA~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~1559X~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0357870	09/21/2009	PA	47.0	47		F	09/18/2009	Next morning after flu shot awoke with reddened @ elbow, heavy sensation in L arm, increased intensity and extending to L shoulder shoulder posteriorly 2 days after shot. Mild stomach pain and diarrhea 2 days after.									U	09/15/2009	09/16/2009	1	None	OTH	PVT	ibuprofen PRN	None	None			1						1	Abdominal pain upper; Diarrhoea; Erythema; Sensation of heaviness	FLU3~SANOFI PASTEUR~U3196AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357871	09/21/2009	NE	70.0	70		F	09/21/2009	Pt. called 9-21 said her R arm was swollen from shoulder to elbow. Red and warm to touch. Asked Pt to call PCP and see what he said. Pt called MD - MD said OK - to use TYLENOL and cold compress for pain.									U	09/19/2009	09/20/2009	1	None	OTH	PVT	XALATAN eye drops; Alendronate, 70 mg					1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2A~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0627Y~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357869	09/22/2009	AZ	42.0	42		M	09/18/2009	Started feeling tenderness, pain in hands, arms, low grade fever muscle weakness in upper extremities; general muscle weakness all over. Follow up with PCP.				Y						09/12/2009	09/13/2009	1	CMP, CBC, TSH, SED RATE, PSA	PUB	PVT		No	No			1						1	Blood thyroid stimulating hormone; Full blood count; Metabolic function test; Muscular weakness; Pain in extremity; Prostatic specific antigen; Pyrexia; Red blood cell sedimentation rate; Tenderness	FLU3~SANOFI PASTEUR~U3205CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357872	09/22/2009	AZ	33.0	33		F	09/21/2009	9/14 - going to bed extremely sore arm.  9/15 - 5 AM to urgent care Rx pain MED.  9/15 - Small amount of redness - pencil eraser size.  9/16 - silver dollar size redness - no discharge, minimal swelling, to ER Rx antibiotics, no explanation given.  To PCP - Dx cellulitis - allergic reaction, viral syndrome.  Fever 102.7 very fatigued, H/A extreme pain.				Y					Y	09/14/2009	09/14/2009	0	Unknown	OTH	PVT	None	None	Reports neurological (local) reaction to other vaccines.			1						1	Cellulitis; Erythema; Fatigue; Headache; Hypersensitivity; Pain in extremity; Pyrexia; Swelling; Viral infection	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~96031P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1296X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0357875	09/22/2009	OH	18.0	18		F	09/17/2009	A cluster of seven patients who all received FLUZONE SV 2009-2010 (lot number U3186AA): One patient experienced blurry vision, ringing in ears, and subsequently became pale and unresponsive; the six other patients all experienced localized injection site reactions. Initial report received on 08 September 2009 from a health care professional. An 18 year old female patient, with no medical history and no illness at the time of vaccination, received first intramuscular injection of FLUZONE SV 2009-2010 (lot number U3186AA) in the right arm on 04 September 2009 at 10:15. The patient had no concomitant medications and no adverse events following prior vaccination. Seven minutes after vaccination, at 10:22, the patient was standing at the check-out window and stated that she couldn't see, her vision blurry and her ears ringing. The patient was asked to sit down and she was given a lollipop since she hadn't eaten breakfast. The patient was talking, and while the physician was examining her, she became pale, unresponsive, her eyes closed, she slumped in her chair and stiffened. Then her eyes opened and her pupils were dilated. Suddenly, the patient became unresponsive again. She then returned to her baseline in less than 30 seconds in total. The patient's outcome was recovered. The same healthcare professional reported the seven events, which are captured in: 2009-03859, 2009-03804, 2009-03805, 2009-03806, 2009-03807, 2009-03808, and 2009-03809.				Y					Y	09/04/2009	09/04/2009	0		PVT	PVT			No medical history, no concomitant medications, no illness at the time of vaccination and no adverse event following prior vaccination.		200903859	1						1	Blindness; Injection site reaction; Musculoskeletal stiffness; Mydriasis; No reaction on previous exposure to drug; Pallor; Tinnitus; Unresponsive to stimuli; Vision blurred; Musculoskeletal stiffness; Mydriasis; Pallor; Tinnitus; Unresponsive to stimuli; Vision blurred	FLU3~SANOFI PASTEUR~U3186AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U3186AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0357876	09/22/2009	KS	33.0	33		F		Initial report received on 09 September 2009 a nurse practitioner. A 33 year old female patient with a history of asthma, allergies to penicillin, sulfa, latex, and LEVAQUIN developed a reaction two hours post vaccination. On 01 September 2009 at 11 AM the patient received FLUZONE (lot number U3179AA). The number of doses previously received was reported as 10-15 doses, route and site of administration were not provided. At 1 PM the day of vaccination, the patient had pruritus, itching, and a rash at the site of injection. At 9 PM the day of vaccination, the patient had throat constriction which the patient describe as her throat closing in. Treatment included BENADRYL, ZYRTEC, a five day course of MEDROL. The patient had relief in an hour and a half. The rash and itching lasted for three days. The patient did not have any further reactions. List of Documents held by Sender: none.				Y					Y	09/01/2009	09/01/2009	0	not reported	UNK	UNK			Patient has a history of asthma, allergies to penicillin, sulfa, latex, and LEVAQUIN.		200903879	1						1	Injection site pruritus; Injection site rash; Throat tightness	FLU3~SANOFI PASTEUR~U3179A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357878	09/22/2009	FL	25.0	25		F	09/09/2009	Patient had arm being sore at end of day.  Cannot raise arm above shoulder today.  Patient complains today of nausea but not sure if attributed to health condition patient feels deltoid popping.									U	09/08/2009	09/08/2009	0		OTH	PUB			Pregnancy			1						1	Injected limb mobility decreased; Nausea; Pain in extremity	FLU3~CSL LIMITED~07849111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357879	09/22/2009	FL	68.0	68		F	09/14/2009	Diaphoretic, felt faint, numbness in R arm.				Y					U	09/14/2009	09/14/2009	0		PUB	UNK	Unknown	None	SEPTRA;  CODEINE			1						1	Dizziness; Hyperhidrosis; Hypoaesthesia	FLUX~SANOFI PASTEUR~U3207AA~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0357880	09/22/2009	TN	48.0	48		F	09/18/2009	Pt complained of numbness in arm down to tips of fingers from vaccine site immediately after administered.									U	09/18/2009	09/18/2009	0		OTH	OTH		None	None			1						1	Hypoaesthesia; Immediate post-injection reaction; Injection site anaesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357883	09/22/2009	VA	63.0	63		F	09/21/2009	Large red area on rt arm is inflamed and hot.  Pt reports feeling feverish and generally ill two days later.   Today is improving but area is still getting larger but less gone using TYLENOLO and BENADRYL.  F/U 9/21/09 pt doing well still little redness but resolving.									U	09/15/2009	09/15/2009	0	None	OTH	PUB	PRILOSE; CRESTOR; AMBIEN; NORVASC; DIOVAN; LEXOPRO.	None	Acid reflex; hypertension; hypercholesterolia; depression			1						1	Dermatitis; Erythema; Malaise; Pyrexia; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960323P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1124X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357884	09/22/2009	MO	52.0	52		F	09/14/2009	Arm erythema, painful to the touch, sob, hoarseness, aches, pain, palpitations.				Y					U	09/11/2009	09/13/2009	2	Given Rx PNR AUGMENTIN / VICODIN	OTH	PVT		None	None			1						1	Dysphonia; Dyspnoea; Erythema; Pain; Pain in extremity; Palpitations	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848P1C~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357885	09/22/2009	CA	25.0	25		F		Pain between the spine and shoulder muscle stiffness on left side - neck down to the shoulder. From rate 1-10 (Pt says 8-9) experienced pain after 30 minute of vaccination, last about 48 hours.										09/18/2009	09/19/2009	1		UNK	UNK						1						1	Arthralgia; Musculoskeletal stiffness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357886	09/22/2009	CA	71.0	71		M	09/21/2009	24 hrs after vaccination, pt's neck (both front & back) start to swell and it last about 48 hrs after recovered there is no residual effect.									Y	09/04/2009	09/05/2009	1		UNK	UNK						1						1	Local swelling	FLU3~SANOFI PASTEUR~U3185AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357887	09/22/2009	OH	50.0	50		F	09/14/2009	Headache, Fever, Arm Swollen, Arm Pain, Rash.				Y						09/10/2009	09/11/2009	1		OTH	PVT			Emphazema			1						1	Headache; Oedema peripheral; Pain in extremity; Pyrexia; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97850PL~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0037Y~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0357897	09/22/2009	IL	55.0	55		M	09/14/2009	Rash on legs, knees & forearms.  Used BENADRYL gel.									Y	09/09/2009	09/11/2009	2	None	PUB	PVT		None	None			1						1	Rash	FLU3~CSL LIMITED~01449211A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~1435X~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357911	09/22/2009	CA	67.0	67		F	09/21/2009	Extreme case of cellulitis (according to Dr) that required an E.R. visit on Thursday or Friday 9/17 or 9/18 that progressed to require hospitalization. Pt called and spoke to dispensing pharmacist on Wed 9/16 to report slight fever and redness at site.  10/26/09:  ED Records received for Date of Service 9/17/09 and Medical Record and Discharge Summary received for dates of service 9/18/09 to 9/21/09.  Final Dx:  LUE Cellulitis, hypertension, hypercholesteremia, elevated transmainases.  Assessment:  Presented to the ED on 9/17 with fever, chills, swelling and redness that developed the day following flu shot.  Given ceftriaxone and Keflex and sent home.  On recheck on 9/18 the area of redness was greatly increased and patient was admitted with a low-grade fever and leukocytosis.  Started on IV Vancomycin, and swelling and tenderness decreased, pt. became afebrile.  AST and ALT were mildly elevated.  Blood pressure was fine while in the hospital.  Discharged on Bactrim DS with swelling, erythema, tenderness and warmth greatly decreased in the left deltoid area.  To follow up with PCP in 3-5 days.    ICD 9 Codes:  999.39, 682.3, 401.9, 272.0, 790.5, 530.81, E879.8, E849.6				Y	Y				U	09/15/2009	09/16/2009	1	10/26/09:  ED Records received for Date of Service 9/17/09 and Medical Record and Discharge Summary received for dates of service 9/18/09 to 9/21/09. Labs and Diagnostics:  AST (H), ALT (H).	OTH	PUB			10/26/09:  ED Records received for Date of Service 9/17/09 and Medical Record and Discharge Summary received for dates of service 9/18/09 to 9/21/09. PMH:  HTN, Hypercholesterolemia, NKDA.			1						1	Cellulitis; Injection site erythema; Pyrexia	FLU3~SANOFI PASTEUR~U3190AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1296X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0357917	09/22/2009	CA	40.0	40		F	09/16/2009	On Sep 1 2009 pt received Inactivated INFLUENZA on left deltoid IM. Pt came 9/16/09 and stated she still had a dull pain, or soreness in her arm. There is no redness, itching or swelling at the injection site, asked pt to go to MD. office.									Y	09/02/2009	09/02/2009	0		OTH	PVT			Unknown			1						1	Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~978461~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357918	09/22/2009	NE	21.0	21		F	09/04/2009	Felt lightheaded about 5 minutes after vaccination. She laid down and passed out for about 5 seconds. Rescue squad checked her over and she left with no trouble.									Y	09/04/2009	09/04/2009	0		OTH	PVT						1						1	Dizziness; Loss of consciousness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357922	09/22/2009	IL	66.0	66		F	09/16/2009	Pt states she hasn't been able to move her arm since receiving the vaccine.									U	09/15/2009	09/15/2009	0		OTH	OTH	MOVIPREP Solution					1						1	Mobility decreased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841p1~2~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~06327~2~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357923	09/22/2009	WA	10.0	10		F	09/15/2009	Confusion lasting < 24 hours 5 days after vaccination, no fever but felt warm. Now back to normal. No other s/s illness.				Y					Y	09/03/2009	09/08/2009	5	CBC; Lytes; glucose	UNK	UNK	None	None	ZITHROMAX; Last asthma S/S 4-02,			1						1	Blood glucose; Confusional state; Full blood count; Laboratory test; Skin warm	FLUN3~MEDIMMUNE VACCINES, INC.~500673P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0357926	09/22/2009	NC	10.0	10		M	09/16/2009	Mild inflammation with erythema 8-10cm now spreading down upper arm from site of vaccination (gradual increase erythema spread over 2 days since vaccination) + warmth to site - increase drainage, no pt fever.									U	09/14/2009	09/14/2009	0	None	PVT	PVT		Viral pharyngitis	Peanut allergy (and tree nuts)			1						1	Injection site erythema; Injection site inflammation; Injection site warmth	FLU3~SANOFI PASTEUR~U3203AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357927	09/22/2009	ME	2.0	2	.2	M	09/16/2009	9.3 x 6.5 cm area of erythema with a 6.5 x 5 cm area of induration around punctures sites on R upper outer arm, mild tenderness to touch, warm to touch.									U	09/14/2009	09/15/2009	1	None	PVT	PUB	Albuterol neb as needed	none	Asthma			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U3208AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF696AB~3~IM~RA~HIB (ACTHIB)~1	USA		Influenza
0357928	09/22/2009	IL	73.0	73		F	09/17/2009	Gave flu shot, and pt started bleeding. Then almost immediately, hard, big lump at injection site formed. Gave pt ice pack!									U	09/17/2009	09/17/2009	0		OTH	OTH	HCTZ 25 mg	None	High cholesterol			1						1	Haemorrhage; Injection site mass	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357931	09/22/2009	MI	37.0	37		M	09/18/2009	Within 2 minutes of shot he felt lightheaded & dizzy, sat down and almost passed out.  Also felt numbness all over, sat for 10 minutes, still felt numbness/tingling in face.  Sweaty also.  Sat for 10 min. longer.  Felt better drinking water & glucose tablets.									Y	09/18/2009	09/18/2009	0	None	OTH	PVT	Unknown	None	None			1						1	Dizziness; Hyperhidrosis; Hypoaesthesia; Hypoaesthesia facial; Immediate post-injection reaction; Paraesthesia	FLU3~CSL LIMITED~08549111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357936	09/22/2009	NC	68.0	68		F	09/18/2009	Pt broke out in hives on arms, neck, chest, and abdomen.  Pt reported to PCP who prescribed a MEDROL dose pack & topical BENADRYL.				Y					U	09/16/2009	09/17/2009	1		OTH	OTH		None	NKDA			1						1	Urticaria	FLU3~SANOFI PASTEUR~U3192AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357939	09/22/2009	NV	1.1	1	.1	F	09/14/2009	5X3 cm Erythema, very itchy, red and raised around injection. Lesion continued to increase in size. Rechecked 24 hour later, put on KEFLEX. 2 days later not hot, not swollen, decreased size, only slight.									Y	09/10/2009	09/11/2009	1		PVT	PVT		No	No			1						1	Injection site erythema; Injection site pruritus; Injection site rash	FLU3~SANOFI PASTEUR~113184AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~11F272AA~2~IM~RL~HIB (ACTHIB)~1	USA		Influenza
0357940	09/22/2009	IL	62.0	62		F	09/15/2009	Swelling, redness, and warmth in arm several hours after receiving PNEUMOVAX.  BENADRYL was given to the patient.									U	09/14/2009	09/14/2009	0		OTH	OTH		None	Vloxx			1						1	Erythema; Oedema peripheral; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0627Y~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357942	09/22/2009	IA	68.0	68		F	09/16/2009	Flu vaccine given @ 0922 AM.  Onset of chills (shaking) followed by fever to 102 degrees.  C/O nausea, diarrhea and muscle aches.  Also c/o fingers on left hand were numb feeling.  Took OTC antacid for stomach upset.  Symptoms resolved by 0800 on 9-16-09.									Y	09/15/2009	09/15/2009	0		PVT	PVT	PRILOSEC; LOPRESSOR; ASA; FLONASE; ESTRADIOL; MVI	None known	None			1						1	Chills; Diarrhoea; Hypoaesthesia; Myalgia; Nausea; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U3191AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357943	09/22/2009	MT	56.0	56		F	09/18/2009	Patient received self limiting left sided facial edema, with no shortness of breath, rash, LOC, etc. The reaction occurred several hours after administration, but did not require medical attention.									Y	09/11/2009	09/11/2009	0		UNK	UNK	No Known	None	NKMA wasp venom			1						1	Face oedema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357945	09/22/2009	FL	79.0	79		F	09/17/2009	Pt reported arm swelling and bruise where she received influenza vaccination (at 3:58 PM 9/16/09).  Firm swelling 1 diameter) surrounding arm site that is affected.  (Approx 12. below site arm diameter is 11).  Hematoma present @ injection site 1 in diameter.  Able to move arm.  Returned 24 hours later 9/17.  No change in condition.  Ecchymotic changes present with Hematoma.  Referred to Primary Care MD.  Pt refused.  She consulted with her son who is a DPM.  No treatment required.									Y	09/15/2009	09/15/2009	0		OTH	PVT	Unknown	None	Unknown			1						1	Injection site haematoma; Injection site induration; Injection site swelling	FLU3~SANOFI PASTEUR~~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357946	09/22/2009	IL	65.0	65		F	09/13/2009	Pt given PNEUMOVAX & FLUVIRUI in same arm at same time b/c pt s/p mastectomy and no lymph nodes in right arm.  Pt experienced 3 X 3 in flamed rash which was very painful and feels hard to the touch.  Tingling radiates down left arm to fingers, comes and goes with position.									Y	09/11/2009	09/11/2009	0		OTH	OTH	EVISTA; ATENOLOL; TRIANIT/HCTZ; MVI		S/P right mastectomy 2005; Hypertension; Osteoporosis.			1						1	Induration; Inflammation; Pain; Paraesthesia; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0627Y~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0357947	09/22/2009	IN	76.0	76		F	09/11/2009	Following injection, patient reported redness and swelling of arm around injection site.  Throughout day, worsened and pt went to emergency room where she was treated for cellulitis.				Y					Y	09/02/2009	09/02/2009	0		OTH	PVT	LEVOXYL 75 mg QD.	None	Hypothyroidism			1						1	Cellulitis; Injection site erythema; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~06274~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0357949	09/22/2009	MI	71.0	71		F	09/16/2009	Thursday- Sept. 10 6pm - vaccine; 11 pm - stomach discomfort; 3 am- vomiting - 3 times; Fri - Sun - dull headache, severe diarrhea, unable to do anything. No fever. Any activity made heart race.									Y	09/10/2009	09/10/2009	0	none	OTH	PUB		none	Osteopenia; tachycardia; mild high cholesterol			1						1	Abdominal discomfort; Activities of daily living impaired; Diarrhoea; Headache; Palpitations; Vomiting	FLU3~SANOFI PASTEUR~U31670A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357950	09/22/2009	NY	34.0	34		M	09/17/2009	Shortness of breath, coughing, lightheaded, nausea.  Running nose.				Y					Y	09/17/2009	09/17/2009	0		PVT	PUB	None	Head injury; Hyperthium.	hyperthium; head injury.			1						1	Cough; Dizziness; Dyspnoea; Nausea; Rhinorrhoea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA449BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0357951	09/22/2009	MO	35.0	35		F	09/17/2009	Shot was given in Lt arm.  Patient reported tingling & itching running up it.  Arm to Lt side of face.  Welting observed.  Throat also tingling.  FNP called.  DIPHENHYDRAMINE 50 mg given in Lt hip & an oral XYZAL mg given.  Pt responded well.									Y	09/17/2009	09/17/2009	0		PVT	OTH	Hospital employee health.	None	PCN	~Influenza (Seasonal) (no brand name)~1~33.00~Patient		1						1	Paraesthesia; Pruritus; Throat irritation; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA468AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0357952	09/22/2009	MA	12.0	12		M	09/18/2009	Mother called 9/18/09 @ 1:46p to report symptoms of: sore throat, sneezing, cough, headache, fever, achy, no appetite. Mom states He gets this every year.									U	09/15/2009	09/18/2009	3		PVT	PVT		None	None			1						1	Cough; Decreased appetite; Headache; Oropharyngeal pain; Pain; Pyrexia; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~500675P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B036BA~6~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0357953	09/22/2009	OH	24.0	24		M	09/17/2009	FLUVIRIN vaccine administered in Rt arm 9/16/09 @ 3:30pm and overnight developed swollen, red, hardened left side of neck.  Came back to pharmacy & advised to see MD.				Y					U	09/16/2009	09/17/2009	1		OTH	OTH	Unknown	None	None			1						1	Erythema; Induration; Local swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~9784191~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357954	09/22/2009	CA	82.0	82		F	09/18/2009	On 9/18/09 this volunteer for hospital presented with erythema and tenderness to her right deltoid, which progressed since receiving seasonal flu vaccine on 9/16/09 at 0930. Denies need for analgesia, full ROM RUE, CSM's adeq RUE. Afebrile. Visible erythema, warm to touch R deltoid area, extends down arm to just above R elbow - exterior only. [TST neg; 0mm; on 9/18/09].									U	09/16/2009	09/16/2009	0		PVT	PVT	COUMADIN; PPD	None	Atrial fibrillation; HTN			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U3179AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357958	09/22/2009	IL	13.0	13		M	09/15/2009	Mother stated child developed 2X3inch red area on deltoid, where vaccine was administered. No other symptoms were noted. On 9/15, redness 50% improved.									Y	09/11/2009	09/12/2009	1	None	OTH	OTH	None	Possible impetigo in groin - related to hot tub.	None			1						1	Erythema	FLU3~SANOFI PASTEUR~U3174FA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357959	09/22/2009	MO	49.0	49		F	09/18/2009	Pt said lymph node swollen on left side the next day.									U	09/17/2009	09/18/2009	1		OTH	OTH						1						1	Lymphadenopathy	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P1~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357960	09/22/2009	AZ	5.0	5		F	09/16/2009	Fever only up to 102 degrees 1 day later.  The patient came today at 5 years of age with complaint of elevated temperature for 2 days it  has resolved today.  Of note is the fact that the child did receive the FLUMIST vaccine on September 10 and developed a temperature elevation on September 11.  Her temperature is gone of 202 degrees with no other specific complaints.  She has had no fever today.  She does reportedly complained of some ear pain.									Y	09/10/2009				PUB	UNK						1						1	Body temperature increased; Ear pain	FLUN3~MEDIMMUNE VACCINES, INC.~500709P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0357961	09/22/2009	NV	4.0	4		F	09/14/2009	Local reaction 3 - cm - Redness and tenderness no fever.										09/10/2009	09/12/2009	2		PVT	PVT	None	None	None			1						1	Erythema; Local reaction; Tenderness	DTAP~SANOFI PASTEUR~C3141AA~5~UN~RA~DTAP (DAPTACEL)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~297843~4~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|IPV~SANOFI PASTEUR~D00039~4~UN~LA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0357966	09/22/2009	WV	7.0	0	.5	M	09/22/2009	Flumist given on Thursday, Sept. 17, 2009.  Symptoms started Saturday with sore throat and a little drainage.  By Monday, Sept. 21, low grade fever.  By Tuesday, Sept. 22, fever of 102 degrees.									U	09/17/2009	09/19/2009	2		PVT	UNK	Rynatan		Dust allergies			1						1	Oropharyngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0357967	09/22/2009	VA	39.0	39		F	09/22/2009	RASH 2 HOURS POST VACCINE. LATER, SAME DAY RASH ON FACE. NEXT DAY, RASH FROM HEAD TO FEET AND FACIAL EDEMA.  WENT TO THE ER AND WAS TREATED WITH SOLUMEDROL AND ZANTAC THEN DISCHARGED. RX'S FOR HOME WERE PREDNISONE, VISTARIL AND ZANTAC.				Y					Y	09/19/2009	09/19/2009	0	NONE	PVT	PVT	SEASONIQUE, PROPANOLOL, BUSPAR	NONE KNOWN	RED FOOD DYE, NUTS AND SEASONAL MILD ALLERGIES	BREATHING DIFFICULTY~Influenza (Seasonal) (no brand name)~NULL~30.00~In Sibling1		1						1	Face oedema; Rash generalised	FLU3~CSL LIMITED~AFLUA470BA~7+~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0357968	09/22/2009	MO	79.0	80		F	09/22/2009	she presented to the clinic with redness and swelling in left arm. swelling extended down into elbow, red and warm to touch. dr fears ordered bactrim bid				Y					U	09/15/2009	09/18/2009	3		MIL	MIL	ketoralac tromethamine drops, prednisolon acetate drops, moxifloxcian hydrochloride drops, ibandronate sodium, metoprolol succinate, sulfamethoxazol/trimethoprin, nitrofurantoin/nitrouran mac	no	codiene, floxin			1						1	Erythema; Oedema peripheral; Skin warm	FLU3~CSL LIMITED~01749211a~4~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~1162x~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0357971	09/22/2009	MO	73.0	73		M	09/22/2009	an hour and a half after getting a regular flu shot(1040am) my heart rate suddenly  increased and my blood pressure dropped (1210pm). about 4:00pm my heart rate remained elevated, but my blood pressure dropped futher. i called my cardiac health nurse line to report my condition. they advised water and rest. about six hours after the reaction started, my heart rate returned to normal. my blood pressure rose, but it continued to be irratic.									Y	09/17/2009			none. only heart clinic monitoring	PUB	PUB	coreg, cozaar, amiodarone, lipitor, asprin		pacemaker-defibrillator			1						1	Blood pressure decreased; Heart rate increased	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0357973	09/22/2009	OR	38.0	38		F	09/22/2009	ABOUT 10 MINUTES AFTER RECEIVING THE SEASONAL FLU VACCINE, VICTIM NOTICED SHE WAS SLIGHTLY DIZZY AND THAT SHE HAD BITTEN HER TONGUE REPEATEDLY IN THE LAST FEW MINUTES, ALSO SHE HAD TINGLING ON HER ARM AND ON HER FACE. SHE SAT DOWN AND NURSES WERE CALLED. VITAL SIGNS AND O2 SATS WERE NORMAL BUT VICTIM STARTED SLURRING HER WORDS AND STATED HER TONGUE FELT LARGER AND HER THROAT FELT TIGHT. 50MG. IM BENADRYL WAS ADMINISTERED AT THAT POINT. AFTER 10-15 MINUTES VICTIMS SPEECH NO LONGER SLURRED AND SHE STATED RESOLUTION OF THROAT TIGHTENING, TONGUE VISIBLY SMALLER AND PER HER NOW NORMAL IN SIZE. VITAL SIGNS WERE NORMAL THROUGHOUT AS WELL AS O2 SATURATIONS. ADVISED TO SEE HER PCP AND REPORT THIS REACTION TO THE FLU SHOT. ON INTERVIEW THE FOLLOWING DAY, VICTIM STATED SHE HAD HAD NO OTHER SYMPTOMS OR RETURNING SYMPTOMS OVER THE 24 HOUR PERIOD.									Y	09/17/2009	09/17/2009	0		PUB	PUB			HISTORY OF ASTHMA ALLERGY TO PCN			1						1	Dizziness; Dysarthria; Paraesthesia; Swollen tongue; Throat tightness; Tongue biting	FLU3~SANOFI PASTEUR~U3203AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357975	09/22/2009	CA	48.0	48		F	09/22/2009	9/18/09 8am  client called and returned to clinic to have RN check vaccine reaction.  Left anterior deltoid visibly red, with swelling around injection site.  60mm X60mm raised area.  Client denies fever or other S & S.  Recalls similar reaction approximately 4 years ago. Has had flu vaccine last 3 years with no reaction									Y	09/17/2009	09/18/2009	1	None	PUB	PUB		No	HIV			1						1	Injection site erythema; Injection site swelling; Similar reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~U3186AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357979	09/22/2009	NY	52.0	52		F	09/22/2009	Within 1/2 hour of vaccine administration c/o pins and needles in fingers and arms and had difficulty breathing seen by Dr in Medical clinic recieved 50 mg of Benedryl and 40 mg of oral Prednisone and had a nebulizer treatment.  Breathing improved but still c/o feeling very tired and like I was run over by a truck.  Employee has a history of asthma and recieves allergy shots.  Also stated that the counts for pollen and ragwood are very high today and has never taken flu vaccine this early (has taken it for past 20 years).  Reports that the only other time she had a similiar reaction was several years ago when she took it this time in the early fall and not waited for a couple of good frosts to lower the pollen//ragweed counts.				Y					Y	09/22/2009	09/22/2009	0	Bp 150/101 (very high usually runs low	UNK	UNK		Asthma	Asthma			1						1	Dyspnoea; Fatigue; Hypertension; Paraesthesia; Similar reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~U3231AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357980	09/22/2009	CA	50.0	50		F	09/22/2009	I was injected with the flu vaccine on Friday, September 18, 2009 at approximately 2:30 pm. I woke up on Sunday morning with a big bump on my top lip which got worse throughout the day and night. On Monday morning, I woke up at 4:30 am with a cluster of blisters on my lip, upper respiratory wheezing and heaviness, and the left side of my neck felt like I had a swollen gland. As yesterday progressed, my lip (the left side)got bigger and more infectious looking. I called the doctor and she apologized for my reaction, and said she didn't know I might be allergic to egg yolks. I never signed a release form at her office. This morning, my lip looks even worse and the left side of my face is swollen and tender. The doctor isn't in until tomorrow, so I am going to my dermatologist to have my lip examined. I am in pain and scared that I am getting worse, not better. 12/08/09 Medical records received for DOS 11/17/04-9/23/09 Pt  called PCP to notify of  lip swelling and tenderness and plan to see dermatologist. DX: HSVI cold sore 12/11/09  Dermatology medical records received for DOS 10/11/2000-9/22/2009. DX: Herpes Simplex Virus, flaring (9/22/09)				Y					U	09/18/2009	09/20/2009	2		UNK	UNK		NONE	NONE 12/08/09 PHM Hypothyroidism  12/11/09 PMH: Impetigo; Allergic to sulfa, PCN, egg yolks			1						1	Chest discomfort; Lip blister; Lip swelling; Lymphadenopathy; Pain; Swelling face; Tenderness; Wheezing	FLU3~SANOFI PASTEUR~U3184AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357981	09/22/2009	MI	80.0	80		M	09/22/2009	patient says muscle still tender after 1 week. pt tried an aspirin and an aleve tablet. pt applied topical theragesic cream...still sore. Arm does not feel warm and no red areas seen. No heart palpitations or difficulty in breathing									N	09/16/2009	09/17/2009	1		UNK	PUB						1						1	Myalgia; Pain in extremity	FLU3~CSL LIMITED~05849111a~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357982	09/22/2009	UT	4.0	4		F	09/22/2009	Patient put in car after receiving shot at Dr's office.  Fell asleep in car on the way home & making odd motion with mouth.  Left in car for a few minutes while at home while the rest of the family entered the vehicle.  She became less responsive, increasing in palor, brought to the ER by father.  Found to be very pale, with cyanosis to lips, not breathing with O2 sats in 60% range.  Posturing motions with arms and gazing to R.10/13/2009 MR from ED visit 9/21/2009, patient presents with sx of unresponsiveness, decreased respirations, odd motions of the mouth, ? seizure like activity, cyanotic episode. Patient required intubation as depressed respirations and O2 sats of 60%. Patient transferred to another hospital for continuing care.			Y	Y	Y	3			U	09/21/2009	09/21/2009	0	Labs: CBC: Hct 42 high, CMP: Glucose 140 high, Arterial blood gases: PO2 487 high, O2 sats 60% low, Ua normal Xrays: Ct head normal, CXR normal	UNK	UNK	none	none	none PMH: none Allergies: NKDA	none~ ()~~0.00~Patient|none~ ()~~0.00~Sibling		1						1	Cyanosis; Depressed level of consciousness; Dyskinesia; Gaze palsy; Oxygen saturation decreased; Pallor; Posturing; Respiratory arrest; Blood test; Computerised tomogram; Confusional state; Dyskinesia; Dyspnoea; Electroencephalogram; Respiratory arrest; Somnolence; Speech disorder; Staring; Unresponsive to stimuli	FLU3~SANOFI PASTEUR~U3198AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U3198AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0357984	09/22/2009	MS	3.0	3		F	09/22/2009	rash began about 1 hour after shot given- whelp type rash to trunk/extremities with swelling of eyes/face; benadryl given; c/o abdominal pain & low grade fever through night. Seen at urgent care clinic following a.m.-given Zyrtec and Pepcid with improvement in symptoms over next few hours-active/alert/NAD				Y					Y	09/21/2009	09/21/2009	0	none	PVT	PVT	none	no	none			1						1	Abdominal pain; Eye swelling; Pyrexia; Rash; Swelling face; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97847P1~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0357987	09/22/2009	GA	24.0	24		F	09/22/2009	Developed cough, throat/chest tightness, itchy eyes 2-4 hours after administration of flu vaccine. Sent for treatment to urgent care facility. On dicharge placed on Benadryl, pain medication. Had CT scan with contrast and it was 0 for pulmonary embolism.				Y					Y	09/22/2009	09/22/2009	0		UNK	UNK		Recently recovered from unknown illness.	Nonspecific allergy to grasses, wheat.			1						1	Chest discomfort; Computerised tomogram normal; Cough; Eye pruritus; Throat tightness	FLU3~SANOFI PASTEUR~U3204AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0357993	09/22/2009	WA	52.0	52		F	09/22/2009	Within two hours of vaccination, the left arm had begun swelling, with associated pain, and fever.  This was post work hours, and had already gone home, took Ibuprofen 400mgs, went to bed.  Awakened in night several times, with sweats (102 Degrees, F), pain, and lymph node swelling.  Called into sick, informed LeadWorker as to what was happening.  Intermittent sweats, fevers and pain from swelling through day.  Fever finally broke that evening, took more Ibuprofen 400mg, slept through night, arm swollen, painful.  Swelling decreased next morning, called in sick due to unilateral pain, continuing swelling, numbness in arm and hand (L).  Obtained appointment with MD that PM. Rested through rest of day, swelling decreasing, cont. numbness, pain, pins and needles effects.  MD diagnosed cellulitis secondary to vaccination, provided scrip for Bactrim DS and Keflex, and note to return to work the next day, which I did.  Swelling has greatly decreased, some discoloration of arm, pins and needles and intermittent numbness still occurring.									U	09/14/2009	09/14/2009	0		MIL	MIL		None				1						1	Cellulitis; Hypoaesthesia; Lymphadenopathy; Night sweats; Oedema peripheral; Pain in extremity; Paraesthesia; Pyrexia; Skin discolouration	FLU3~SANOFI PASTEUR~unk~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0357996	09/22/2009	CO	67.0			U	09/22/2009	three days after injection patient reported 2 inch red circle painful to touch									U					UNK	PUB	benicar 20 mg, metoprolol succ er 50, simvastatin 20mg, fluoxetine 10,boniva 150 mg,					1						1	Erythema; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960325p~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARZOS~MERCK & CO. INC.~0745y~UNK~SC~~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0357997	09/22/2009	WA	31.0	31		F	09/22/2009	Pt complained of itching, redness of both arms and feeling that the tongue is thick. Felt light headed but no SOB. Pt got the new Flu shot Afluria 1 hour ago. Dr in to assess pts' condition. Epi 0.3 given IM. Zyrtec 10 mg po and Prednisone 40 mg po. Observed for 1 hour. Taught use of twinject and recognition of anaphylaxis.									Y	09/21/2009	09/21/2009	0		MIL	MIL						1						1	Dizziness; Erythema; Pruritus; Tongue disorder	FLU3~CSL LIMITED~07049111A~2~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357998	09/22/2009	NC	42.0	42		F	09/22/2009	12 hours after vaccine, general feeling of malaise, weakness. Progressed over next 12 hours to headache, neck ache, myalgia ( generalized ) and general feeling unweel									U	09/21/2009	09/21/2009	0		MIL	UNK		none	none			1						1	Asthenia; Headache; Malaise; Myalgia; Neck pain	FLU3~CSL LIMITED~~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357999	09/22/2009	GA	32.0	32		F	09/22/2009	Developed chest/throat tightness, flushing, low grade fever, cough within 3-4 hours of receipt of seasonal influenza vaccine.  To ER, albuterol nebulizer given. Diagnosed with vax reaction. Discharged with steroids, benadryl, and nebulizer treatment.				Y					U	09/22/2009	09/22/2009	0		UNK	UNK	Albuterol inhaler.	None.	Sulfa, seasonal allergies.  Has eczema.			1						1	Chest discomfort; Cough; Flushing; Pyrexia; Throat tightness; Vaccination complication	FLU3~SANOFI PASTEUR~U3204AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358000	09/22/2009	CA	53.0			F	09/22/2009	3 hours after receiving seasonal influenza vaccine developed sharp and throbbing pain at the injection site which radiated to the outer elbow, 6-8/10. Four hours after receiving the vaccine, felt malaise, weakness in the affected arm, decreased appetite, and use of arm. Didn't sleep well, due to arm discomfort and malaise, woke up with malaise, arm pain, lightheaded on change of position, hot eyes, decreased appeatite, two loose stools. Took Motrin 600mg and Alleve orally with improvement.									Y					PUB	UNK	Compounded Estrogen Progesterone cream topical every day	None	None			1						1	Decreased appetite; Diarrhoea; Dizziness; Eye burns; Injected limb mobility decreased; Injection site pain; Malaise; Muscular weakness; Pain in extremity; Poor quality sleep	FLU3~CSL LIMITED~06649111A~7+~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358003	09/22/2009	SC	73.0	73		F	09/22/2009	Immediately after receiving flu vaccine, patient complained that she felt funny and that her tongue felt tingly.  She stated that she did this sometimes when she was allergic to something. Patient was assessed by 2 nurses, had no hives, edema, no respiratory distress.  BP was 158/72, pulse 100 and regular, respirations regular and unlabored.  Patient drank about 4 oz of water while being observed in clinic for approximately 15 minutes.  Patient left the clinic with her daughter.  She stated that she felt better, just weak.  RN recommended that patient go to ER if she did not improve.  Hospital called the Health Dept. on 9/18/2009 to report that patient had gone to the Emergency Department with respiratory distress and hives shortly after leaving the Health Department and was admitted to the hospital on 9/17/2009 and had been discharged on 9/18/2009. 9/24/09 ER rec records rec'd for DOS 9/17/09 with dx:  Allergic Reaction.  Diabetes. CAD. Pt presented with c/o airway tightness, weakness, dizziness, itching, swelling of throat and lips, trouble swallowing and lip tightness after receiving Flu shot.  Tx with epi, benadryl, and steroids. D/C home improved.			Y	Y	Y	1			Y	09/16/2009	09/16/2009	0		UNK	UNK	ACTOS, ADVAIR, CARDIZEM CD, ERGOCALCIFERAL, IMDUR, LANOXIN, LASIX, NITROSTAT, OXYBUTYNIN, PERCOCET, RANEXA, VALIUM, ACTONEL, LEXAPRO, LOVASTATIN, OMEPRAZOLE, ZANTAC, METOPROLOL	EMPHYSEMA, HYPERTENSION	BUTORPHANOL TARTRATE, DARVOCET, IODINE, MEPERIDINE, NALBUPHINE, PENICILLIN, SODIUM METABISULFITE, SULFA PMH:  DM, CAD, Heart disease, angina, MIx2, asthma, emphysema, CABG, HTN, Appy, tonsilectomy, hysterectomy		SC0926	1						1	Asthenia; Feeling abnormal; Heart rate normal; Immediate post-injection reaction; Paraesthesia oral; Respiratory distress; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA259AA~4~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening,Hospitalisation	Influenza
0358004	09/22/2009	OR	41.0	41		F	09/22/2009	Rash and some itching appeared on trunk and left arm (admin arm) on 9/18/09 around 3 hours after injection.  Treatment antihistamine.									Y	09/18/2009	09/18/2009	0	None	UNK	PVT						1						1	Rash pruritic	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA256AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0358005	09/22/2009	VA	55.0	55		F	09/22/2009	Whole body itching, esp. of scalp and legs with raised red bumps on legs (serous fluid with crusting) developed 2-3 hours after vaccination received. Took several doses of Benadryl po and resolved after 2 days. Dry cough, tightness of throat, and some shortness of breath continue after 4 days.									Y	09/17/2009	09/17/2009	0		UNK	UNK	Crestor 5mg qd, Centrum, Vitamin D 1000iu, Move Freely (glucosamine and chondroitin), Fish oil 1200mg	None	High cholesterol, Arthritis, Minor eczema			1						1	Cough; Dyspnoea; Erythema; Pruritus generalised; Rash papular; Swelling; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA279AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0358006	09/22/2009	MA	49.0	49		F	09/22/2009	TIngling/numbness down arm and in hands immediately.  Apply ice pack this diminished.  Then proceeded to weekness in knees and tingling on bridge of nose.									U	09/22/2009	09/22/2009	0		PUB	UNK		slight sinus cold				1						1	Asthenia; Hypoaesthesia; Immediate post-injection reaction; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838p1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358007	09/22/2009	NJ	32.0	32		F	09/22/2009	Around 11 pm started coughing and wheezing it stopped after I inhaled Flovent. The next event happened around 1:30 am I woke up with shivers, heart racing, and vomiting. This event lasted until 2 am.  When I woke up at 7 am my stomach felt very weak and my arms and body were very achy.									N	09/21/2009	09/21/2009	0		PUB	UNK	Benicar 20 mg	none	High blood pressure			1						1	Abdominal discomfort; Chills; Cough; Pain; Palpitations; Vomiting; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0358010	09/22/2009	PA	82.0	82		F	09/22/2009	Swollen right arm from elbow to forearem									U	09/18/2009	09/19/2009	1		UNK	UNK	Lisinopril 40mg         Levothyroxine 125mcg	none reported	none reported	na~ ()~NULL~~In Patient		1						1	Oedema peripheral	FLU3~SANOFI PASTEUR~u3209aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1125x~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358011	09/22/2009		48.0	48		F	09/22/2009	Pt rcvd immunization on Friday and developed macular-papular rash of arms, legs, torso on third day accompanied by itching.  No change in personal care products.  No ingestion of new foods/beverages/medications.  Rash continues on fifth day. Tx. Benadryl, Calamine, hydration, observation.									N	09/18/2009	09/21/2009	3	none	MIL	MIL	HCTZ 25mg daily	none	none	none~ ()~NULL~~In Patient|none~ ()~NULL~~In Sibling1|none~ ()~NULL~~In Sibling2		1						1	Pruritus; Rash macular; Rash papular	FLU3~CSL LIMITED~05649111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358015	09/22/2009	OR	41.0	41		F	09/22/2009	Swollen node left side of neck.									U	09/16/2009	09/18/2009	2		OTH	PVT	Unknown	Unknown	Unknown			1						1	Lymphadenopathy	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97845P1~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358016	09/22/2009	IL	74.0	74		F	09/22/2009	The patient received a flu shot on Wed 9/16 and came back for the pneumonia vaccine since she can only have shots in one arm.  There were multiple needing flu shots & she was thought to need both that day so the flu was administered a second time on Thurs.  9/17 instead of the pneumonia.  There was no adverse reaction.									Y	09/17/2009				OTH	PUB						1						1	Wrong drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~2~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358017	09/22/2009	IL	52.0	52		F	09/22/2009	Pt called 9/20/09 and complained of being in pain from Friday (9/18/09). Ever since she received the flu vaccine she has been feeling Pins and Needles in her fingers and hand and numbness down her whole arm. She has been in so much pain it woke her up out of her sleep. As of 9/22/09 she is still in pain but feels 50% better: but still feels pins and needles.									Y	09/18/2009	09/18/2009	0		OTH	PUB						1						1	Hypoaesthesia; Pain; Paraesthesia; Sleep disorder	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0627Y~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358018	09/22/2009	NC	34.0	34		F	09/22/2009	Vanish Point retractable syringe 25G x 1 used. The needle retracted with the first push (bypassed the medication administration) and the full dose dripped down pt's skin. Pt states skin feels tingly, it is not painful, but just the skin the medicine touched feels tingly. Pt stated about 15 mins. later, skin is less tingly and still no pain. Pt's status no pain, much improved at 20:06. Will f/u with her Dr. tomorrow.									Y	09/22/2009	09/22/2009	0		OTH	OTH			CODEINE allergy			1						1	Accidental exposure; Medical device complication; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P1~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358019	09/22/2009	CA	65.0	65		F	09/22/2009	Approximately 1-2 hours afterwards, the patient went to ER due to swelling/ redness at the injection site & flu like symptoms.  Per patient WBC count 22,000.  Patient was discharged w/ KEFLEX (antibiotic).				Y					Y	09/16/2009	09/16/2009	0	WBC count: 22,000	OTH	OTH		None	None			1						1	Influenza like illness; Injection site erythema; Injection site swelling; White blood cell count increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0627Y~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358020	09/22/2009	IA	49.0	49		F	09/22/2009	Used 1 1/2 needle  over 240 lbs noticed resistance.  Pulled Back & injected.  Felt some resistance Pt. reported some discomfort, said she had some shooting pain up to neck until 4 AM 9-22-2009 now has bad ache 9 22- 5 pm.				Y					U	09/21/2009	09/21/2009	0		OTH	PVT		None				1						1	Discomfort; Pain	FLU3~CSL LIMITED~08449111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0358021	09/22/2009	IN	33.0	33		F	09/21/2009	Patient said she was experiencing swelling in the back of the throat and difficulty swallowing.									Y	09/21/2009	09/21/2009	0		OTH	PVT		None	Penicillin and sulfa allergy.			1						1	Dysphagia; Pharyngeal oedema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358022	09/22/2009	WI	45.0	45		F	09/22/2009	Pt received FLUZONE on 9/15/09 at 15:00. She began to feel ill by 21:00 that same day. She c/o chills, body aches x 24 hours. On 9/18/09 she awoke feeling itchy and had welts over her arms, legs and torso. She has had a rash every evening afterward x 3. All sx's have currently cleared.									Y	09/15/2009	09/15/2009	0	None	PVT	UNK	AZELEX cream; NASONEX; COPAXONE inj.; ZOLOFT; ADVAIR; ALBUTEROL	None	Multiple sclerosis; rosacea			1						1	Chills; Malaise; Pain; Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U3178AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358024	09/22/2009	NY	21.0	21		F	09/22/2009	Syncope episode, lightheaded, nausea, dizzy, seeing black fuzzy spots, flu-like symptoms (sweaty, chills). Pt rest for 15 mins. and got better.									Y	09/18/2009	09/18/2009	0		OTH	OTH	None	None				1						1	Chills; Dizziness; Hyperhidrosis; Influenza like illness; Nausea; Syncope; Visual impairment	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358025	09/22/2009	MI	48.0	48		M	09/22/2009	Patient was breathing very deeply.  Patient was very sweaty.  Did not respond to my voice or shaking.  Continued to shake the patient and he came too.  Said he felt like he was dreaming.  He was very pale.  Called 911.									Y	09/22/2009	09/22/2009	0		OTH	PVT						1						1	Dreamy state; Hyperhidrosis; Hyperventilation; Pallor; Unresponsive to stimuli	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358026	09/22/2009	CA	66.0	66		F	09/21/2009	Had fever of >103 and projectile vomiting.									Y	09/15/2009	09/16/2009	1	None	OTH	OTH		No	Bradycardia, allergic bronchitis asthma			1						1	Pyrexia; Vomiting projectile	FLU3~CSL LIMITED~06449111A~1~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358027	09/22/2009	KY	18.0	18		F		Fever N/V, soreness at site within 15 min. after vacc.				Y					U	09/21/2009	09/21/2009	0	Flu test neg, CBC nl	PVT	PVT						1						1	Full blood count normal; Influenza serology negative; Injection site pain; Nausea; Pyrexia; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU468BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0358028	09/22/2009	VA	40.0	40		F	09/22/2009	Sx began 4 hours after vaccine admin.  1. Significant pain in L arm.  2.  Arm weak & not able to lift it.  3.  Severe Diarrhea, body cramping.  4.  Swollen L arm, welts, sweating.  5.  Difficulty breathing still  some residual swelling to L arm.  Pt has possible autoimmune disease (possible lupus?)				Y					Y	09/20/2009	09/20/2009	0		UNK	UNK	LIPITOR;  EFFEXORD;  SYNTHROID;  LYME;  ALTREX	Bronchitis 2 weeks prior	Shrimp;  Morphine;  SULFA			1						1	Diarrhoea; Dyspnoea; Hyperhidrosis; Injected limb mobility decreased; Muscle spasms; Muscular weakness; Oedema peripheral; Pain in extremity; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~9733401~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358029	09/22/2009	VA	6.0	6		F	09/22/2009	A/P neck pain - right side of neck with muscle fullness. Questionable reaction to HeP A. Motrin every 6 hours today.									U	09/21/2009	09/22/2009	1	None	PVT	PVT		None	None			1						1	Muscle swelling; Neck pain	FLUN3~MEDIMMUNE VACCINES, INC.~5007098~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~MERCK & CO. INC.~02674~2~IM~RA~HEP A (VAQTA)~1	USA		Influenza
0358031	09/22/2009	MI	59.0	59		F	09/22/2009	Breathing difficulties started about 3 hrs. post flu vaccine, severe coughing, headache, sinus pressure, eye drainage, weakness in right hand, throat felt funny.  Patient called in today with the above information and stated she did not go to ER last night because of transportation issues.  Was instructed to go to ER today as we have no appointments.									Y	09/21/2009	09/21/2009	0		PVT	PVT	B complex Vitamins Solution; CYELOBENZAPRINE HCI 5 mg tablet; PROVENTIL HFA 108 (90 Base) MCG/ACT Aerosol Solution; PROVIGIL 200 mg tablet; REBIF 22 MCG/0.5 ml solution; Stool softener caps; VALTREX 500 mg tablet.	Left sup scapular pain	Multiple sclerosis; pain disorder; asthma; Tietze's syndrome.			1						1	Cough; Dyspnoea; Eye discharge; Headache; Muscular weakness; Sinus headache; Throat irritation	FLU3~SANOFI PASTEUR~U3210AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358034	09/22/2009	CA	67.0	67		M	09/22/2009	Patient experienced chest pain immediately after receiving vaccine.  Chest pain lasted about 2 hrs.  Vaccine left a large bruise on right deltoid about 1-2 inches in diameter.									Y	09/14/2009	09/14/2009	0		PUB	UNK						1						1	Chest pain; Contusion; Immediate post-injection reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358036	09/22/2009	MI	23.0	23		M		Says shot did not hurt but 5-10 mins later he said he felt dizzy and his arm started to hurt (the arm which he received the injection in). His blood pressure and pulse rate dropped very low. 911 was called. By the time the EMTs arrived his BP and PR were normal.				Y					Y	09/10/2009	09/10/2009	0		OTH	PVT	BENADRYL 25 mg	Sinus drainage				1						1	Blood pressure decreased; Dizziness; Heart rate decreased; Pain in extremity	FLU3~CSL LIMITED~069491114~UNK~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0358037	09/22/2009	VA	50.0	50		F	09/22/2009	Seen in clinic 9/17/09 with L arm injection site swollen, red, hot, 25 x 50 mm. C/o pain radiating to post neck and jaws bilaterally increasing with hand movements. Full ROM, sensation, the ROM limited by pain with movement. Recheck 9/18/09. Referred to PCP. Initial rec. ice packs, observe.									U	09/15/2009	09/17/2009	2		PUB	OTH	COUMADIN	None	Hx blood clots, clotting deficiency			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Joint range of motion decreased; Neck pain; Pain in jaw	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA449BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0358040	09/22/2009	TX	12.0	12		F	09/15/2009	Given MENACTRA, GARDASIL, Influenza Vaccines.  Approximately one minute after administration, adolescent, while sitting down, had syncopal episode, landed face first on floor braking glasses causing 2 lacerations to right eye between eyebrow & eyelid.				Y					Y	09/14/2009	09/14/2009	0	Eye exam + stitches	PVT	PVT	ALBUTEROL;  MDI;  SINGULAIR	None	Asthma			1						1	Fall; Ophthalmological examination; Skin laceration; Syncope	FLU3~SANOFI PASTEUR~U317615A~4~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~00874~2~UN~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2919AA~1~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0358042	09/22/2009	OH	76.0	76		M	09/14/2009	-patient got flu & pneumo shots on Wed 9-9-09 at flu shot/vaccination clinic at Kroger Pharmacy #825 -2 days later (on 9-11-09), patient's wife noted redness & swelling around elbow on vaccination arm-patient came into pharmacy on Friday evening-elbow area was red, swollen, not warm to touch-sent to nurse practitioner next door-> -was diagnosed with cellulitis (may or may not related to vaccines) & given prescription folz pack -per patient's wife->almost all cleared up by Mon 9-14-09.				Y					Y	09/09/2009	09/11/2009	2	Physical exam only	OTH	PUB	Lasix, Prednisone, Chantix	None	NKDA->conditions: COPD, hypertension, cholesterol			1						1	Cellulitis; Injection site erythema; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA259AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1162X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358047	09/22/2009	NY	45.0	45		F	09/22/2009	Employee states slight numbness of the tongue-no SOB, able to speak. Ambulated to ER. Observation for 60 minutes and returned to work.				Y					Y	09/22/2009	09/22/2009	0	None	UNK	OTH	None	None	Nickel			1						1	Hypoaesthesia oral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA470AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0358048	09/22/2009	WI	62.0	62		F	09/17/2009	Pt. complains of a sore left shoulder- Received injection (FLUVARIN) 9/1/09 still having problems as of 9/17/09. Pt. called 9/8 saying she had a problem with her arm (see back)									N	09/01/2009	09/14/2009	13		OTH	PVT		None				1						1	Musculoskeletal pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358051	09/22/2009	FL	3.0	3		F	08/17/2009	A non-serious, spontaneous report of fever was received from a consumer concerning a 47-month-old female patient subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No relevant medical history was reported for this patient and the patient was not receiving any concomitant medications. The patient received FLUMIST intranasal on 17 Aug 2009 at 9:30 AM for INFLUENZA vaccination. The patient has not previously been exposed to FLUMIST. On 17 Aug 2009 around 2:00 PM the patient experienced a fever reaching 102.2 Degrees Fahrenheit which was treated at home with acetaminophen. It was noted the patient's 18-month-old sibling was sick with diarrhea at the same time. The fever lasted for approximately 36 hours and was considered resolved on 19 Aug 2009.									Y	08/17/2009	08/17/2009	0		PVT	OTH	Concomitant Drug (s) Not Used				MEDI0008785	1						1	Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0358053	09/22/2009	CA	31.0	31		M	09/05/2009	Rash all over body about 2-3 hours.  Pt tried sleeping it off and woke up to a worse rash.									U	09/04/2009	09/04/2009	0		OTH	PVT		Pneumonia on 8/27;  Pericardial effusion	None			1						1	Rash generalised	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358062	09/22/2009	CA	22.0	22		F	09/17/2009	Large area of arm turned red and very swollen, and hot to touch. Arm went numb for 1 day and nausea after the shot.									Y	09/11/2009	09/12/2009	1		OTH	OTH	None	None	None			1						1	Erythema; Hypoaesthesia; Nausea; Oedema peripheral; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2~2~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358064	09/22/2009	TX	6.0	6		M	09/21/2009	9/10/09 gave Flu shot right deltoid before leaving office was itchy a little red. 9/11/09 24 hr after shot arm was swollen from the shoulder to elbow, red, warm to touch, occ pain, no itching no joint pain. Was told to give BENADRYL when he left and also x 24 hr no help. 9/12/09 started on oral steroids. Noticed improvement. After 36 hr on the steroids oym. were gone									Y	09/10/2009	09/10/2009	0	None	PVT	PVT	None	None Healthy No egg allergy	Allergic Rhinitis occasional			1						1	Injection site erythema; Injection site pain; Injection site pruritus; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3211AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358074	09/22/2009	NY	3.0	3		F	09/10/2009	4cm x 3cm reaction at immunization site. Also fever 103 orally noted.									Y	09/08/2009	09/08/2009	0	None	PVT	UNK		None	None			1						1	Injection site reaction; Pyrexia	FLU3~SANOFI PASTEUR~U3259EA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~00244~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358075	09/22/2009	TX	4.0	4		F	08/27/2009	A non-serious spontaneous report of eye exposure to FLUMIST was received from a registered nurse concerning a four-year-old male. The patient's medical history and concomitant medications were not reported. During the administration of the second half of FLUMIST, the patient turned his head and some of the FLUMIST got in his eye. Also, some of the FLUMIST leaked out of his nose. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponser causally assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune;s post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. 10/14/2009 A non-serious spontaneous report of eye exposure to FLUMIST was received from a registered nurse concerning a four-year-old female. The patient's medical history and concomitant medications were not reported. On 27-Aug-2009, during the administration of the second half of the first dose of FLUMIST, the patient turned her head and some of the FLUMIST got in her eye. Also, some of the FLUMIST leaked out of her nose. On 14-Oct-2009, the reporter confirmed there was no adverse event associated with this medication error therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information was received on 14-Oct-2009 and incorporated into the narrative included: confirmation the patient did not experience any adverse events, the patient's date of birth, correction to patient's sex, and number of FLUMIST doses administered.									Y	08/27/2009	08/27/2009	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0008816	1						1	Drug administered at inappropriate site; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~500677P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0358076	09/22/2009	FL	4.0			F	08/17/2009	A non-serious spontaneous report of fever has been received from a consumer in the United States concerning a four year-old female. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Medical history and concomitant medications were not reported. On 17 Aug 2009 at 9:30 am, the patient received FluMist. At the time of reporting on 17 Aug 2009, the patient had a fever of 102.2. The outcome of the event was not reported.									N	08/17/2009	08/17/2009	0	Body temperature, 102.2	PVT	OTH	Concomitant Drug (s) Not Reported				MEDI0008781	1						1	Body temperature increased; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0358077	09/22/2009	OK	2.0	2	.2	F	08/22/2009	A non serious spontaneous report of spaces out; not sleeping well; cranky; whiney; fever and  decreased appetite has been received from a parent concerning a 26 month old female, subsequent to FluMist. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FluMist 17 Aug 2009. The parent reported that since receiving the vaccine the patient has been spaced out; not sleeping well; cranky/whiney, fever; and decreased appetite. The outcome for spaced out; not sleeping well; cranky/whiney; fever; and decreased appetite was not reported.									U	08/17/2009	08/17/2009	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0008799	1						1	Decreased appetite; Feeling abnormal; Insomnia; Irritability; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0358078	09/22/2009	OH	1.6			M	08/21/2009	A non-serious spontaneous report of inadvertent administration and Fever has been received from a nurse concerning a 19-month-old male, subsequent to FluMist. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications have been reported for this patient. The patient inadvertently received FluMist on 18 Aug 2009. The nurse reported the event of fever that developed after the administration of FluMist. The cutcome of fever was not reported.									U	08/18/2009	08/18/2009	0		PVT	OTH	Concomitant Drug (s) Not Reported				MEDI0008795	1						1	Inappropriate schedule of drug administration; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500675P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0358079	09/23/2009	WI	4.0	4		F	09/21/2009	Urticaria - given BENADRYL in clinic.									Y	09/17/2009	09/17/2009	0		PVT	UNK		none				1						1	Urticaria	FLU3~SANOFI PASTEUR~U3178AA~5~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0598Y~1~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0358080	09/23/2009	MD	59.0	59		F	04/20/2009	(See attached). 10/12/09 Hospital records, DC summary, received service dates 11/26/08 to 12/03/08. Assessment: Guillain-Barre Syndrome. Patient noted achiness in her back and down into her legs one week ago. Pain increased and developed in palms and fingertips, generalized tingling sensation in toes and finger tips. Patient presents with burning sensation in lateral thighs and aching feeling in calves. Fingertips and feet are numb. Urinary frequency. Little sleep at night. Muscle weakness extremities, deceased temperature and pain sensation. Wide-based, ataxic gait. Needs assistance with ambulation. IVIG.  ICD-9 Codes: 357.0 Ac Infect Polyneuritis, 781.3 Lack of Coordination, 782.0 Skin Sensation Disturbance, 788.41 Urinary Frequency, 781.2 Abnormality of Gait.   10/14/09 Neurology consult records received, service dates 11/25/08 to 8/25/09. Assessment: Guillain Barre Syndrome. Patient presented with a 1 week history of weakness, pain, and achiness in back and legs. Pain in palms and fingertips, tingling and parasthesias.  Tingling progressed to the toes.  She also developed imbalance and weakness with several falls.  Reflexes are absent throughout.  Upon follow up from hospitalization:  remains unsteady, using a cane.  Unable to drive.  Feet feel like bricks.  Needs assistance with ADL's (showering).  Pain can be incapacitating. Knee pain since fall 6 weeks ago.  Absent reflexes in LE's, diminished reflexes in biceps.   Gait is shaky. 8/25/09-Compared with the initial study on 11/26/09 the degree of demyelination and axonal loss is worse, likely a reflection of continued injury to the nerves during the acute phase of her illness.			Y	Y	Y	10			N	10/28/2008	11/12/2008	15	(See attached).  10/12/09 Hospital records, DC summary, received service dates 11/26/08 to 12/03/08. LABS and DIAGNOSTICS: CSF - RBC 3 /mm3 (H), Protein 120 mg/dL (H). CHEM - Sodium 132 mmol/L (L) BUN 24 mg/dL (H). CBC - WBC 4.53 K/MM3 (L). IGG 1670 mg/dL (H). Lymab (Lyme Disease) Antibody test - WNL. ANA - WNL. CRP - WNL. Rheumatoid Factor - WNL. 10/14/09 Neurology consult records received, service dates 11/25/08 to 8/25/09.  Labs and diagnostics:  ANA-Negative, CRP-Negative, Rheumatoid factor-Negative, Lyme testing-Negative.  EMG-Abnormal.	PVT	OTH	(See attached)	None	Uterine fibroids. 10/12/09 Hospital records, DC summary, received service dates 11/26/08 to 12/03/08. Tonsillectomy, chevron osteotomy, ectopic pregnancy. Former smoker. 2 glasses wine per night.  10/14/09 Neurology consult records received, service dates 11/25/08 to 8/25/09.PMH:  Depression and as above.			1						1		FLU3~CSL LIMITED~00849211A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Life Threatening,Hospitalisation	Influenza
0358091	09/23/2009	CO	61.0			F	09/21/2009	Shot area red, swollen, painful 4x4 area 101 degree-Temp. Extreme chills, aches, pain, headache, nausea, shot on 8/28 am - sick, 8/29, 8/30,8/31,9/1 am-pm. Went  into bronchitis sinus infection. Sick 9/1-9/2.									Y					OTH	PVT		None				1						1	Bronchitis; Chills; Headache; Injection site erythema; Injection site pain; Injection site swelling; Nausea; Pain; Pyrexia; Sinusitis	FLU3~SANOFI PASTEUR~90658~2~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~90732~2~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358092	09/23/2009	PA	37.0	37		F	09/19/2009	Headache, sea sick feeling when changing positions, moving head. Home measures. Call office if not feeling better in next 24 hours.									Y	09/14/2009	09/15/2009	1	None	PVT	OTH	None	None	None			1						1	Headache; Motion sickness	FLU3~SANOFI PASTEUR~U3209AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358093	09/23/2009	IL	69.0	69		F	09/11/2009	Patient came back in 1 hour after shot was administered claiming her throat was closing up tingling around shoulder and groin. Just not feeling right Patient later said she fell as well. 1 EPIPEN was administered which improved patient status. EMS came and patient refused therapy.										09/11/2009	09/11/2009	0		OTH	PVT	Unknown	None	Dust, Mold allergies, Hypothyroid			1						1	Fall; Feeling abnormal; Paraesthesia; Throat tightness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358095	09/23/2009	NE	54.0	54		F	09/17/2009	Patient complained of ligh-headness and numbness if lips. No difficulty breathing, no treatment given. patient left pharmacy after 2 hours.									Y	09/17/2009	09/17/2009	0	None	OTH	PVT	None	None	PCN; Sulfa; Shellfish; Whole wheat; Tree nuts; Latex			1						1	Dizziness; Hypoaesthesia oral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358097	09/23/2009	CO	63.0	63		F	09/23/2009	Patient received Subq vaccine by IM Route. Had sore muscle.									Y	09/11/2009	09/12/2009	1		OTH	PVT						1						1	Incorrect route of drug administration; Myalgia	FLU3~SANOFI PASTEUR~U3190AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~0140Y~1~IM~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0358098	09/23/2009	CO	26.0	26		F	09/23/2009	Employee complains of feeling dizzy & vomited. Donor laid in office and received no medications.									Y	09/23/2009	09/23/2009	0		OTH	PVT	Prenatal Vitamins	vomiting, dizzy	PCN			1						1	Dizziness; Vomiting	FLU3~CSL LIMITED~07849111A~1~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358099	09/23/2009	CO	34.0	34		F	09/23/2009	Employee complains of headache and dizziness. Donor laid in office and received no medications.									Y	09/23/2009	09/23/2009	0		OTH	PVT		Dizzy				1						1	Dizziness; Headache	FLU3~CSL LIMITED~D7849111A~1~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358100	09/23/2009	CO	24.0	24		F	09/23/2009	09/23/09 Employee complains of feeling dizzy and faint. Donor laid in office x 30min. No medications given.									Y	09/23/2009	09/23/2009	0		OTH	PVT		Dizzy faint feeling	CEFZIL; Scoliosis; PCOS			1						1	Dizziness	FLU3~CSL LIMITED~07849111A~1~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358104	09/23/2009	NJ	25.0	25		F	09/23/2009	Patient had received flu vaccine at 11am and around 12:00pm started to feel SOB and noticed what she thought was an insect bite. The next evening 9/22/09 was completely red and had hives and difficulty breathing was seen and treated at ER and released. She was given IM Benadryl - Steroids injection and Rx for - Medrol dose pk. Benadryl and Pepcid.				Y						09/21/2009	09/21/2009	0		OTH	OTH	Albuterol inhaler prm	None	Allergy to  Iv compound; IV dye; Reglan - Asthma			1						1	Dyspnoea; Erythema; Urticaria	FLU3~SANOFI PASTEUR~U3187AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358105	09/23/2009	MA	25.0	25		F	09/23/2009	Starting at about 4 hours after the shot had a headache.  At 6 hours after mild fever began and severe body ache and eyes very dry and red.  At around 7 hours began to have sore throat which was not listed under symptom.  Tingling in nose as if I have to sneeze but am unable.  Very tired and irritable.  Today is the next day and I feel all these symptoms at once.  It is nearly as bad as actually having the flu.  Not recovered yet but I suspect I will. Don't know who manufactured it but I had to enter something or I couldn't complete the form.									U	09/22/2009	09/22/2009	0		UNK	UNK	Mirena	None	IBS			1						1	Dry eye; Fatigue; Headache; Irritability; Ocular hyperaemia; Oropharyngeal pain; Pain; Paraesthesia; Pyrexia	FLU3~SANOFI PASTEUR~U3188AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358106	09/23/2009	FL	31.0	31		F	09/23/2009	Mild nosebleed - self-treated by pinching nose with Kleenex									Y	09/22/2009	09/23/2009	1	None	UNK	PVT	None	None	None			1						1	Epistaxis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~unknown~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358108	09/23/2009	IN	54.0	54		F	09/23/2009	Constant ache in arm between elbow and shoulder.  Tender at injection area. Can't raise my arm without pain.  I am seeing my physician 9/24/09. Vaccination was given by pharmacist.									N	09/11/2009	09/11/2009	0		UNK	UNK	zoloft, caduet	no	none			1						1	Injected limb mobility decreased; Injection site pain; Pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~5~IJ~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0358109	09/23/2009	NE	47.0	46		M	09/23/2009	Tingling on left side of face, started approximately 5 minutes after receiving the flumist - lasted about 12 hours.   Tingling did not fluctuate - face was not hot, just tingly.									Y	09/18/2009	09/18/2009	0	None	MIL	MIL			Hayfever			1						1	Paraesthesia	FLUN3~MEDIMMUNE VACCINES, INC.~500685P~5~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0358111	09/23/2009	OK	47.0	47		F	09/23/2009	Area around injection site red, swollen,very painful and warm to touch									U	09/22/2009	09/22/2009	0		UNK	PVT		None	None			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97845P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358112	09/23/2009	OH	56.0	56		F	09/23/2009	Hives throughout body within 6-7 hours after seasonal influenza vaccination.  C/O itching, headach, nausea, along with hives.				Y					U	09/21/2009	09/21/2009	0		UNK	UNK		Being worked up for neurologic condition	Allergic to codeine and fiorinal	Fever~Influenza (Seasonal) (no brand name)~~0.00~Patient		1						1	Headache; Nausea; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0358113	09/23/2009	CO	4.0	4		M	09/23/2009	Severe local reaction, erythema. Benadryl 25mg q 4-6 hrs as needed				Y					Y	09/18/2009	09/19/2009	1		PUB	PUB			bronchiolitis, autistic disordere			1						1	Erythema; Local reaction	DTAP~SANOFI PASTEUR~U247ba~3~IM~LL~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~500687p~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0733y~2~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0358116	09/23/2009	IN	59.0	59		F	09/23/2009	Developed redness and swelling at injection site next day 9/17/09 then fever 103. Instructed per phone conversation with Advil and Benadryl. Went to ER 9/19/09 and treated Keflex 500 qid Benadryl 25-50 q 4-6 hour. Seen at physician office 9/21/09 Keflex 500 qid X 3 additional days. Diagnosed with Cellulitis.				Y					Y	09/16/2009	09/17/2009	1	N/A	UNK	UNK	Fosamax 70mg; Femara 2.5mg;Adalatt 60mg;HCTZ 12.5mg;Allegra 180mg;Symbicort 160/4.5;Singulair 10 mg;Prevacid 30mg;Kdur 20 meq;Fluticasone nasal spray	None stated	Penicillin Neggram Sulfa Asthma Shingles, Breast CA, Osteopenia,HTN			1						1	Cellulitis; Injection site erythema; Injection site swelling; Pyrexia	FLU3~SANOFI PASTEUR~U3196AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0024Y~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358117	09/23/2009	AL	2.0	25		M	09/17/2009	A bad burn like rash with whelps around the vaccine site.				Y					U	09/10/2009	09/12/2009	2		UNK	UNK		None	N/A			1						1	Injection site rash; Injection site urticaria; Rash erythematous	FLU3~SANOFI PASTEUR~u3195aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358118	09/23/2009	OH	1.42	1	.5	M	09/23/2009	This child was signed up by administrative staff for the FluMist which was not age appropriate. Vaccine was given to this 17 month old by an RN that was volunteering (MRC Volunteer) at our flu immunization clinic. Reported to our Medical Director. No adverse events noted. Attempting to notify the patients parent at this time. Will boost with Pediatric Fluzone.									Y	09/22/2009	09/22/2009	0	N/A	PUB	PUB		None				1						1	Wrong drug administered	FLUN3~MEDIMMUNE VACCINES, INC.~500707P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0358119	09/23/2009	VA	19.0	19		F	09/22/2009	Cellulitis for 3-5 days per patients mom. Whom is a LNP, cellutis only presented on left deltoid									Y	09/11/2009	09/14/2009	3	N/A	UNK	UNK		none				1						1	Cellulitis	FLU3~SANOFI PASTEUR~u3192AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~00378~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358120	09/23/2009	IN	48.0	48		F	09/23/2009	urticarial rash				Y					U	09/22/2009	09/23/2009	1		PUB	PUB	Humira,Daypro	NO	RA			1						1	Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua458ba~6~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0358122	09/23/2009	PA	61.0	61		F	09/23/2009	received flu vaccine on 9/18/09. that same afternoon c/o itching. today (9/23/09)reports to health center c/o fine red rash and increase itching to neck, upper chest, ears and B/L forearms. Benadryl 25 mg po, benadryl cream, Medrol dose pak.									U	09/18/2009	09/18/2009	0		UNK	UNK	trilipids, crestor, zoloft	no	nkda,  K.B states she thought she outgrew her allergy to Thimerosol. approx 15 years ago she had swelling and redness to face after using contact lense cleaner w/ thimerosol. denies recent past hx of reaction to flu vaccines.			1						1	Pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~U3184AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358123	09/23/2009	MN	37.0	37		F	09/23/2009	Patient states via email Got my flu shot Friday a.m. and by late Friday night I started with a rash, which continues today (9/21).  Little itchy bumps.  Seems to like my joints.  Started on the elbows, then to knees, today ankles and wrists starting to itch.									Y	09/18/2009	09/18/2009	0		UNK	UNK						1						1	Rash generalised; Rash pruritic	FLU3~SANOFI PASTEUR~U3191AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358124	09/23/2009	NH	1.25	1	.3	F	09/23/2009	Received Pentacel, Prevnar and Fluzone vaccines in morning - that afternoon, developed fever.  8pm-ish, eyes rolled back and little foaming at mouth and both arms and legs jerking - lasted about one minute and then tired - given Tylenol and soon thereafter to bed.  At about midnight, again, felt hot, eyes rolled back, whole body jerking; vomited once during event but no choking or gagging - lasted about 10 minutes and then tired.  Next day, little not herself but otherwise well.  She has had a little runny nose and cough for a couple of days.Brother with hx of many febrile seizures (none b/o vaccines) so parents didn't seek medical care - called next day (today) to report and brought to office for evaluation; exam non-focal; does have Otitis media with effusion but no signs of acute infection.				Y					Y	09/22/2009	09/23/2009	1	none	PVT	PUB	none	little runny nose and cough but no fever	congenital nevus  -chest			1						1	Cough; Dyskinesia; Fatigue; Feeling abnormal; Foaming at mouth; Gaze palsy; Middle ear effusion; Otitis media; Pyrexia; Rhinorrhoea; Skin warm; Vomiting	DTPPHIB~UNKNOWN MANUFACTURER~c3198aa/c3433aa~4~IM~LL~DTP + IPV + ACT-HIB (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~ut3174ga~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~d57303~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Emergency room visit	Influenza
0358125	09/23/2009	CO	15.0	15		F	09/23/2009	Pt was asked if there was any chance she could be pregnant due to late menses.  She replied, No, my periods are always funky.  During visit, HCG was done and it was positive for pregnancy.  So far, no known adverse reactions.										09/17/2009			HCG Positive.	UNK	UNK	none	None	None			1						1	Drug exposure during pregnancy; Pregnancy test positive	FLUN3~MEDIMMUNE VACCINES, INC.~500687P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0653x~1~IM~LA~HPV (GARDASIL)~1|TDAP~SANOFI PASTEUR~C27773AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0358129	09/23/2009	UT	1.0	1	.0	F	09/23/2009	About 10 days after her mmr vaccine she started having fevers ranging from 99.9-103.3 for about 2 days then on twelfth day after vacc we started seeing small red bumps on face and spread lightly over body, 1 day later the amount of spots has tripled and are bigger in size.  She is uncomfortable but the fevers are at least gone.									Y	09/11/2009	09/20/2009	9		UNK	UNK	tylenol and ibuprofin					1						1	Pyrexia; Rash erythematous; Rash generalised	FLUX~UNKNOWN MANUFACTURER~~1~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~1~IM~LL~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~1~IM~RL~VARICELLA (NO BRAND NAME)~1	USA		Influenza
0358131	09/23/2009	VA	66.0	66		M	09/23/2009	SUBJECT: CALL TO FEE DEPT               R'CVD. CALL W/VOICEMAIL MSG.@ 1:16PM, CALL RETURNED AT 2:38PM AND WAS INFORMED BY UR NURSE, THAT THIS PATIENT HAD A SERIOUS REACTION AFTER THE FLU SHOT HERE YESTERDAY. S/S CONSISTED OF HIVES OVER HIS BODY, ANGIOEDEMA, LIPS AND NASAL SWELLING AND CHEST PAIN. HE WAS TREATED AS SUCH: IV SOLUMEDROL, IV BENADRYL, IV TAGAMET, IVF, DUONEBS FOR WHEEZING (DID NOT PROGRESS TO STRIDOR). HIS CP IS BEING RULED OUT, HE IS TO HAVE A STRESS TEST. PATIENT ALSO HAS ELEVATED D-DIMER.  PATIENT HAS BEEN PROGRESSED TO PO MEDS WITH THE EXCEPTION OF STILL BEING ON IV SOLUMEDROL.  9/29/09 Hospital and  ED records, DC summary, received DOS 9/22/09 to 9/23/09.  Assessment: Atypical chest pain, asthma exacerbation, allergic reaction. Patient developed hives on arms, legs, back, buttocks, groin area, and abdomen. Lips and nose began to swell.   ICD-9 Codes: 708.0 Allergic urticaria, 493.22 Chronic obstructive asthma with acute exacerbation, E949.6 Viral/rickettsial vaccine causing adverse effects, 309.9 Uspecified adjustment reaction, 786.59 Chest pain, 355.9 Mononeuritis of unspecified site, 272.4 Unspecified hyperlipidemia, 600.00 Hypertrophy (benign) of prostate.			Y	Y	Y	2			U	09/22/2009	09/23/2009	1	LABS and DIAGNOSTICS: Myocardial Perfusion Scan - Normal. CHEM - Calcium 8.7 mg/dL (L) Glucose 131 mg/dL (H). CBC - MPV 7.4 fL (L) Neut 95.2% (H) Lymph 3.9% (L) Mono 0.8% (L) Neut ABS 10.1 K/cmm (H) Lymph 0.4 K/cmm (L). Quant D-Dimer 3.70 mg/L (H). CT Pulmonary Angiogram - Abnormal for small nodule (R) lung base. Chest X-ray - Abnormal, degenerative acromioclavicular joints.	MIL	MIL	ALPRAZOLAM 0.5MG TAB TAKE ONE TABLET BY MOUTH TWICE A DAY AS NEEDED FOR ANXIETY FLUNISOLIDE 25MCG NASAL INHL USE 1 PUFF INTO  EACH NOSTRIL TWICE A DAY                      SIMVASTATIN 80MG TAB TAKE ONE-HALF TABLET BY MOUTH AT BEDTIME TAMSUL	none	Prostatitis, Hyperlipidemia, ASTHMA. PMH: Chest pain and difficulty breathing 3-4 days which had resolved prior to vaccination. Asthma/COPD, chronic adjustment disorder, neuropathy, lung nodule, hyperlipidemia, BPH, allergic reactions - hives. Reaction to tetanus toxoid at age 19 consisting of throat swelling. Allergies to flu vaccine, belladonna, and MYTRIN. Skin grafting for burns. Tonsillectomy. Alcohol use.			1						1	Angioedema; Chest pain; Fibrin D dimer increased; Lip swelling; Nasal congestion; Urticaria; Wheezing	FLU3~CSL LIMITED~08349111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Life Threatening,Hospitalisation	Influenza
0358132	09/23/2009	MN	48.0	48		F	09/23/2009	Patient was given a flu shot (Fluzone) in her left deltoid on 9/18/09 late morning/early afternoon. Stated she has had several flu shots in the past without problems. That evening after supper she began feeling itchy all over. Around midnight she stated she developed hives all over. Stated her left arm swelled to double it's normal size from the elbow to shoulder with large hives at the injection site.  She stated she also had some difficulty swallowing.  She stated she has had allergic reactions to medications in the past and did have an epi-pen that she did not use.  She stated she took Benadryl several times for her symptoms.  She was seeing her medical provider for an unrelated reason on 9/21/09 and did notify her of above, stated at the time of her visit she had one hive remaining at the site of her injection.				Y					Y	09/18/2009	09/18/2009	0	None	UNK	UNK	Albuterol neb, Epi-pen, Lisinopril, HCTZ, Singulair, Nortriptyline, Ambien, Percocet, Prempro, Ranitidine	None	Seasonal allergies, HTN, GERD, sleepnessness, neuralgia			1						1	Dysphagia; Injection site urticaria; No reaction on previous exposure to drug; Oedema peripheral; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U3191AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358133	09/23/2009	NY	48.0	48		F	09/23/2009	Immediate chest pain, difficulty breathing, dizziness, seizure-like activity. Medical records/DC summary received 10/9/2009 for 9/22-9/23/2009.  DC Dx reaction to flu shot, Pseudoseizures. 48 y/o received seasonal influenza 9/22/2009 and developed chest pain, SOB, dizziness and seizure like activity. To ED, evaluated per Neuro with final DX of reaction to flu shot, pseudoseizures.					Y	1			Y	09/22/2009	09/22/2009	0	CBC, CMP, UA, CIP x3. ANA, ESR, Antiphosopholipid Antibody,  EKG, EEG, CXR, CT Head WNL	MIL	UNK		none	morphine, fentanyl, PCN, midazolam, bee sting PMH: Migraines, Fibromyalgia, IBS, IC, PTSD, Hx of Alcohol abuse, Panic attacks with pseudo-seizures			1						1	Chest pain; Dizziness; Dyspnoea; Immediate post-injection reaction; Chest pain; Convulsion; Dizziness; Electrocardiogram ST segment abnormal; Electrocardiogram abnormal; Electroencephalogram normal	FLU3~CSL LIMITED~08249111A~7+~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|FLU3~CSL LIMITED~08249111A~UNK~IM~~INFLUENZA (SEASONAL) (AFLURIA)~2	USA	Hospitalisation	Influenza
0358134	09/23/2009	ID	48.0	48		F	09/23/2009	Vaccine administered on 9/21/09 to left deltoid. Symptoms began early morning on 9/22/09 with numbness, tingling, and itching to left hand radiating up left forearm. It comes and goes. Feels similiar to a bee sting with itching and throbbing feeling. Seems to move up and down arm.									U	09/21/2009	09/22/2009	1		UNK	UNK	No	No	None			1						1	Hypoaesthesia; Pain; Paraesthesia; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA468AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0358136	09/23/2009	AK	43.0	43		F	09/23/2009	Rapid heart rate, high blood pressure, itching of tongue and back of throat, hoarseness, slight wheezing, and difficulty breathing.				Y					Y	09/22/2009	09/22/2009	0	none	UNK	PVT	Avvapro 300, Vytorn 10/40, Nexium 40	none	allergies to: penicillen, lisinapril, and constrast dye.			1						1	Dysphonia; Dyspnoea; Heart rate increased; Hypertension; Pruritus; Throat irritation; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA259AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0358137	09/23/2009	FL	56.0	56		F	09/23/2009	At approx 10:15 pm experienced fast pulse, difficulty breathing and swallowing. Called 911 and was taken to Emergency Room. Treated with intravenous saline fluid, oxygen, steroids, Benadryl, anti-nausea due to vomiting, breathing treatment, Tylenol & Motrin for fever. Released at approx 4:30 am. Given prescription for Prednisone 20mg; ciprofloxacin eye drops.				Y					Y	09/22/2009	09/22/2009	0	Chest x-ray, blood test	UNK	UNK		none	Sulfa allergy; High cholesterol; Hypo Thyroid; Osteoperosis;			1						1	Blood test; Chest X-ray; Dysphagia; Dyspnoea; Heart rate increased; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0358138	09/23/2009	NH	34.0	34		M	09/23/2009	Intestinal cramping, somewhat loose stool, body aches and pains, fever ranging from 99.7 to 101, fatigue.									U	09/20/2009	09/20/2009	0	none conducted so far	UNK	UNK	None	None	aspirin allergy(not diagnosed by a doctor)			1						1	Diarrhoea; Fatigue; Gastrointestinal pain; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0358140	09/23/2009	CA	74.0	74		M	09/23/2009	arm edema and erythema + elevated pulse occurred in the evening following the PCV injection				Y					U	09/22/2009	09/22/2009	0	None	PVT	UNK						1						1	Erythema; Heart rate increased; Oedema	FLU3~SANOFI PASTEUR~U32599EA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1162x~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358142	09/23/2009	CO	20.0			U	09/24/2009	arm swelled and she went to physican and he recommended reporting the incident									U					UNK	UNK						1						1	Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~96032 5p~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358153	09/23/2009	OH	74.0	74		M	09/23/2009	Suspected GUILLAIN BARRE - treatment / workup pending.  11/23/09 Extensive ED, hospital, and rehab records received. Multiple evaluations. Service dates 9/18/09 to 10/12/09. Assessment: Guillain-Barre Syndrome. Patient seen in ED several days prior and dx'd with neuropathy. Now presents for pain control of ongoing leg pain of 14 days duration. Myalgias, appears uncomfortable. Lower extremity pitting edema. calves tender. ROM limited. Severe pain in feet, ankles, gastrocs worsened by movement. Weakness in legs. Decreased reflexes. Joint swelling. Renal insufficiency, anemia. Breath sounds diminished. Abdomen tender, distended. Nausea. Bruises to extremities. Urinary frequency. Several days later develops softness in voice, dyspnea, unable to walk, pain in hands. Respiratory failure, hospital acquired pneumonia. Fevers. Intubated / ICU. Delirium. Atrial fibrillation. PEG tube.					Y	24			U	09/01/2009	09/18/2009	17	Lumbar puncture (P) 11/13/09 Extensive ED, hospital, and rehab records received. Multiple evaluations. Service dates 9/18/09 to 10/12/09. LABS and DIAGNOSTICS: CBC - WBC 12.5 K/uL (H) RBC 3.53 M/uL (L) HGB 9.5 g/dL (L) HCT 29.1% (H) RCD 21.4% (H) Gran 93.8% (H) Lymphs 2.6% (L) Grans Abs 11.7 K/uL (H) Lymphs Abs 0.3 K/uL (L) MPV 6.4 fL (L).   CHEM - Calcium 8.4 mg/dL (L) Albumin 2.4 g/dL (L) Total Protein 5.6 g/dL (L) BUN 68 mg/dL (H) Glucose 179 mg/dL (H) Creatinine 2.11 mg/dL (H). PT 27.0 sec (H) INR 2.4 (H). Chest X-ray - Abnormal, cardiomegaly, pulmonary edema, left pleural effusion. EMG - Abnormal.	PVT	PVT	LASIX 80 mg po tabs; RESTASIS 0.05% op Emul; isosorbide mononitrate CR 60 mg po TB24; ferrous sulfate 325 (65 FE) mg po tabs; Darbepoetin Alfa-Albumin 60 mcg/ml IJ soln; sertraline 100 mg po tabs; COREG 12.5 po tabs; K-DUR 20 meq po TBCR; Z	None	Polymyositis; ILD; CAD; DMII; CKD; OSA; Anemia; Atrial fibrillation; Chronic diastolic heart failure; Heart failure; Benign prostatic hypertrophy; HTN.  11/13/09 Extensive ED, hospital, and rehab records received. Multiple evaluations. Service dates 9/18/09 to 10/12/09. Cardiac disease, high cholesterol, MI, gastroesophageal reflux, hypertension, carpal tunnel syndrome, polymyositis/dermatomyositis, coronary artery disease, CHF, obstructive sleep apnea. Basal cell carcinoma. Coronary artery bypass graft (CABG), back surgery, knee surgery.   Allergies to Norvasc, statins.			1						1	Guillain-Barre syndrome; Lumbar puncture	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLL255AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation	Influenza
0358155	09/23/2009	IA	53.0	53		F	09/23/2009	Left upper arm ,red, swollen, warm. 10cm X 12 cm area of erythema. No fever, nausea or vomiting. No tachycardia, palpitations or shortness of breath. No hives.				Y					N	09/19/2009	09/19/2009	0		PUB	OTH	PLAVIX; ASA; VYTORIN; Ranitidine; NITRO QUICK; Atenolol; BENADRYL	None	Morphine; VICODIN; PERCODAN			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~US167CA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358156	09/23/2009	MT	31.0	31		F	09/23/2009	5 min after - Hot, chest and neck started to break out in diffuse rash. To ER lightheaded, nausea, tachy (HR 130) - emesis - hives.				Y					Y	09/21/2009	09/21/2009	0	None	PVT	PVT	Inhaler ALBUTEROL; TYLENOL; BENADRYL x 5 Ds'		Med allergies; Sulfa; PCN; FLEXERIL; IV contrast; NYQUIL			1						1	Dizziness; Feeling hot; Nausea; Rash; Tachycardia; Urticaria; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA458AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0358157	09/23/2009	NV	55.0	55		F	09/22/2009	Injection given into (L) deltoid IM. 24 hrs later there was a large swelling 150% of normal arm circumference, hot painful with some radiation to (L) shoulder. No abscess or drainage or necrosis, no sign of infection.				Y					Y	09/16/2009	09/17/2009	1	None	OTH	PVT	None	None	Hypothyroidism (Hashimotos) on LEVOXYL.			1						1	Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3789AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0867X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358158	09/23/2009	CA	30.0	30		F	09/25/2009	My muscles tightened up, I took a BENADRYL and relaxed - Never had to leave work for this reaction									Y	09/22/2009	09/22/2009	0		UNK	PUB		None	Sulfa	Similar~Influenza (Seasonal) (no brand name)~UN~29.00~Patient		1						1	Muscle tightness	FLU3~SANOFI PASTEUR~U3185AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358159	09/23/2009	MO	44.0	44		F	09/23/2009	Arm is hurting at shot site 9 days later. She says she cannot lift arm very high because of pain. Later she called and said the pain was so bad she is going to the E.R. advice giving by her physician.			Y	Y					U	09/15/2009	09/15/2009	0		OTH	PUB		None	None			1						1	Injected limb mobility decreased; Injection site pain	FLU3~CSL LIMITED~07749111A~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Life Threatening	Influenza
0358160	09/23/2009	MI	24.0	24		F	09/23/2009	At PNEUMOVAX site: 10cm x 10cm area of redness warmth and induration fever 101.7 max, low 100.3. Tx: rest, IB QID, Benadryl 50mg q6 prm.										09/20/2009	09/22/2009	2		PVT	PVT		None	None			1						1	Body temperature increased; Injection site erythema; Injection site induration; Injection site warmth	FLU3~SANOFI PASTEUR~U3199A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~06254~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~UF551AA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0358161	09/23/2009	FL	16.0	16		M	09/23/2009	Ten minutes after receiving influenza vaccine felt dizzy and syncopal, he fell to the ground and bruised nose and cut lip. He was given O2  then transferred to ER and given IV fluids.				Y					Y	09/23/2009	09/23/2009	0	None	PVT	PVT		Viral URI	None			1						1	Contusion; Dizziness; Fall; Mouth injury; Syncope	FLU3~SANOFI PASTEUR~U3208AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358162	09/23/2009	WA	33.0	33		F	09/23/2009	Pt experienced mouth sores, swollen tongue, led edema the evening of vaccination. Called physician. Complained of significant swelling/pain in injection site, swollen tongue,,edema, subjective fever, and malaise which required office visit on 9/22/2009 - Patient reported BEANDRYL was relieving symptoms to a degree - is recovering.				Y					Y	09/16/2009	09/17/2009	1		OTH	PUB	YAZ birth control; tramadol; dicyclomine; lorazepam; prednisolone; PROTONIX; ALLEGRA; FLONASE		Allergic to Penicillin;Bipolar; Rheumatoid Arthritis; Cushing's Syndrome; Fibromyalgia			1						1	Injection site pain; Injection site swelling; Malaise; Oedema; Oedema peripheral; Pyrexia; Stomatitis; Swollen tongue	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0358164	09/23/2009	CA	61.0	61		F	09/27/2009	Patient reported swelling, soreness and redness on upper left arm for 2 days, after injection was given.									Y	09/20/2009	09/20/2009	0		UNK	UNK						1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~9784085~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0625Y~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358165	09/23/2009	WA	43.0	43		F	09/21/2009	First episode of herpes zoster one week after administration of the vaccine.										09/11/2009	09/18/2009	7	None	PVT	UNK	None	None	None			1						1	Herpes zoster	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA257AB~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0358166	09/23/2009	SC	70.0	70		F	09/23/2009	Metallic taste in mouth starting approximately 5 minutes after vaccine and persisted at least 24 hours.									U	09/22/2009	09/22/2009	0	None	OTH	PUB	ESTRACE; NULEV; ZANTAC; Valium	None	Irritable Bowel Syndrome; Seasonal Allergies			1						1	Dysgeusia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848P1C~6~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358167	09/23/2009	WI	25.0	25		F	09/22/2009	5:30 vaccine administered. Dizziness, nausea, felt like vomiting, pallor - 5 minutes following injection - lasted for 30-45 minutes - Heavy chest started about 15 minutes following injection EMT checked vitals.									Y	09/22/2009	09/22/2009	0	6:08 pm BP 118/68, HR 94, Respirations 100, BSL 171	OTH	OTH		None	None			1						1	Blood glucose increased; Chest discomfort; Dizziness; Nausea; Pallor; Respiration abnormal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97847P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358169	09/23/2009	MI	58.0	58		F	09/22/2009	Fever, myalgias sneezing, rhinorrhea, cough.									Y	09/16/2009	09/16/2009	0	None	PVT	UNK		None	Hypolipidermia			1						1	Cough; Myalgia; Pyrexia; Rhinorrhoea; Sneezing	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358170	09/23/2009	CT	76.0	76		M	09/26/2009	Cellulitis at site of injection.				Y					Y	09/21/2009	09/22/2009	1		PVT	UNK		No	Bipolar			1						1	Injection site cellulitis	FLU3~SANOFI PASTEUR~U3186AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0037Y~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358171	09/23/2009	PA	72.0	72		F	09/23/2009	Redness, swelling and tenderness of R upper arm.				Y					Y	09/21/2009	09/22/2009	1		PVT	PVT	See attached		CIPRO;  LEVAQUIN;  FLAGYL;  Nitrofurantoin + PERCOCET			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U3207AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0507Y~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358172	09/23/2009	ME	1.68	1	.7	F	09/22/2009	None at this time.									U	09/22/2009			None	PVT	PVT	None	None Known	Low birth weight			1						1	No adverse event	FLU3~SANOFI PASTEUR~U3208AA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0652Y~3~IM~LL~HEP B (RECOMBIVAX HB)~1|HIBV~SANOFI PASTEUR~UF692AA~3~IM~RL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~D88184~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0358173	09/23/2009	CO	35.0	35		F	09/23/2009	Donor complains of being dizzy and nauseous. No medications given.									Y	09/23/2009	09/23/2009	0		OTH	PVT			Slipped disc			1						1	Dizziness; Nausea	FLU3~CSL LIMITED~078U9111A~1~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358174	09/23/2009	IA	21.0	21		M	09/18/2009	Within 5 minutes-itchy throat, chest tightness. Gave diphenhydramine 50 mg. Observed for 25 minutes. EMS said no signs of anaphylaxis, just anxiety. BP: 130/80. Resp. rate: 16. Pulse: 62. Went to ER and given O2 and BENADRYL.									Y	09/18/2009	09/18/2009	0		OTH	PVT						1						1	Anxiety; Chest discomfort; Throat irritation	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358175	09/23/2009	NC	33.0	33		F	09/23/2009	Injury date 9/15/2009 - short of breath 9am Friday went to work still tired and SOB. Saturday felt more SOB not able to walk up/down halls w/o stopping. Chest hurting and felt disoriented 2am went to WLED got breathing TX. Sunday 4pm still SOB. Came to MCOH w/symptoms of SOB, PFT, 02 sat, XANAX, DX mild Gilliam - Barre reaction by Dr.				Y					N	09/15/2009	09/15/2009	0	02 sat 99%, PFT done	PVT	UNK			No history			1						1	Chest pain; Disorientation; Dyspnoea; Fatigue; Gait disturbance; Guillain-Barre syndrome; Oxygen saturation normal; Pulmonary function test	FLU3~CSL LIMITED~01449211~UNK~UN~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0358177	09/24/2009	NY	44.0	44		F	09/17/2009	Pt. developed Guillain-Barre 3 weeks foll. vaccination. No viral illness described. Travelled & came back from foreign country 8/23/09. D/A: 9/14/09. Intubated 9/17/09.  10/20/09 Hospital records received service dates 9/24/09 to 10/18/09. Assessment: Guillain Barre syndrome. Patient presents with intubation and respiratory failure secondary to Guillain Barre syndrome requiring plasmaphereses. Patient had presented earlier on 9/12/09 with increasing bilateral tingling and numbness, weakness, diarrhea, and was transferred for plasmaphereses. Acute symmetrical ascending flaccid paralysis. Bradycardia. Sinoatrial Node Dysfunction. Abdominal distention. Difficulty swallowing. Polyradiculopathy Immune Mediated. PT - Activities of daily life impaired. Pacemaker implantation.  10/21/09 Hospital Neurology progress notes received service dates 10/2/09 to 10/7/09. Assessment: Acute Inflammatory Demyelinating Polyradiculoneuropathy. Patient also presents with respiratory failure, autonomic dysfunction. IVIG. Undergoing plasmapheresis. Dyspnea. Dysphagia. ICD 9 Codes:  782.0, 357.0, V66.7, 401.9, 518.0, 518.81, 276.1, 344.00, 253.6,  486.0, 276.8, 780.4, 564.00.			Y	Y	Y	24			U	08/30/2009	09/12/2009	13	CSF: WBC 0, RBC 0, Protein 69 increased, Glucose 94.  10/20/09 Hospital records received service dates 9/24/09 to 10/18/09. LABS and DIAGNOSTICS: CBC - WBC 13.6 K/uL (H) RBC 3.60 M/uL (L) HGB 10.7 g/dL (L) HCT 29.7% (L) PLT 443 K/uL (H) Neut 8.6 K/uL (H) Mono 1.3 K/uL (H) Metamyel 1.0% (H) Myelocyte 3.0% (H) Non specific Morph Changes RBC 1% (H). Coagulation - PT 15.6 sec (H) INR 1.33 (H) APTT 64.8 (H) Fibrinogen 1068 mg/dL (H). CHEM - Glucose 148 mg/dL (H) Glucose (WB) 183 mg/dL (H) T protein 8.7 g/dL (H) T Bilirub 1.7 mg/dL (H) D Bilirub 0.4 mg/dL (H) AST 74 U/L (H) ALT 83 U/L (H) LD 270 U/L (H) CK 383 U/L (H). Blood gases - abnormal. Urinalysis -  Glucose >1000 (H) Protein 30 (H) Ketones trace, WBC 5-10, Bacteria few, Sq Epith OCC, Few Budding Yeast. Multiple Chest X-rays - abnormal, left basilar atelectasis, elevation left hemidiaphragm, effusion with left lower lobe, multifocal pneumonia. MRI Cervical Spine - Abnormal, C5/6 disc herniation. MRI Brain - WNL. Barium Swallow - Abnormal. Endoscopy - Endoscopic Fiberoptic Swallow Study - Abnormal. EKG - Abnormal, Sinus Tachycardia. 10/28/09:  Hospital radiology reports received for dates of service 9/14/09 to 9/23/09. Labs and Diagnostics:  CXR Single View:  Heart borderline in size.  Mild left basal pneumonia has developed c/w prior study.  Trace left pleural effusion is now seen.  ET tube ans NG tube are in situ and unchanged position. Fluro GDE Central Venous Acc.  Under fluroscopy and sonography guidance, 43 cm 5 French double lumen picc line catheter was placed with the tip of the PICC line catheter in the region of the superior vena cava.  Satisfactory position of left-sided PICC line catheter.   CXR Single view:  :eft PICC line tip in left jugular vein.  No pneumothorax seen.  PICC line will be repositioned.  CXR Single View:  There is a lower lobe pneumonic infiltrate.  Tubing's are in proper position.  distal end of NG tube twisted inside the stomach.  There is no evidence of pneumothorax.  CXR Single View:  No pneumonia.  Elevated right hemidiaphragm.  Echocardiogram:  Normal left ventricular size and systolic function.	UNK	UNK	None		None 10/20/09 Hospital records received service dates 9/24/09 to 10/18/09. Hysterectomy.			1						1	CSF glucose increased; CSF protein increased; CSF white blood cell count negative; Endotracheal intubation; Guillain-Barre syndrome; Protein total increased; Red blood cell count decreased	FLU3~CSL LIMITED~019492118~1~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Life Threatening,Hospitalisation	Influenza
0358181	09/24/2009	NC	54.0	54		F	09/23/2009	Hands and feet itching and broke out in bumps underneath skin all over hands and feet. Patient was evaluated by a dermatologist, who told pt. it was an allergic reaction to AFLURIA. Started on PREDNISONE pack and fluocinonide cream.				Y						09/15/2009	09/15/2009	0		PUB	PVT	AMITRIPTYLINE; ACTOS PLUS METFORMIN; kidney pill	No	Diabetes			1						1	Hypersensitivity; Pruritus; Rash	FLU3~CSL LIMITED~01449211A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0358182	09/24/2009	MA	55.0	55		F	09/24/2009	Employee indicates within 15 minutes of receiving FLU vaccine she developed itchy eyes, runny nose, mild airway tightness, congestion and cough, used prescribed as amacort in haler and by mouth CLARITIN (per employee takes ibuprofen prophylactically, prior to injections for injection site erythema).									Y	09/23/2009	09/23/2009	0	None	PVT	PVT		None	seasonal environmental allergies - no allergy testing to date, has history of restrictive airway			1						1	Cough; Eye pruritus; Respiratory tract congestion; Rhinorrhoea; Throat tightness; Chest discomfort; Cough; Dyspnoea	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA456AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA456AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA		Influenza
0358184	09/24/2009	UT	49.0	49		F	09/24/2009	Swelling, hot, itchy where shot was given, fever, dizzy, heart racing, pale, horse voice, dry cough, swelling of throat, light headed, itchy face, head and legs. Still experiencing itchy symptoms, swelling in hands feet and shot area. Swelling, hot, red and raised where the shot was given. Hives at times, shot area still red and sore. Hoarse voice, cough at times, swollen hands and feet. Itchy in various places, eyes head, arms, chin, mostly face.				Y					N	09/22/2009	09/22/2009	0		OTH	OTH	LOVASTATIN .40 mc, Vitamins - Multi + E	None	Bee Stings and Iodine			1						1	Cough; Dizziness; Dysphonia; Injection site erythema; Injection site pain; Injection site pruritus; Injection site swelling; Injection site warmth; Oedema peripheral; Pallor; Palpitations; Pharyngeal oedema; Pruritus; Pyrexia; Urticaria; Cough; Injection site erythema; Injection site swelling; Pruritus; Throat irritation; Tremor	FLU3~SANOFI PASTEUR~U3204AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U3204AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0358185	09/24/2009	MI	48.0	48		F	09/23/2009	FLULAVAL .5 cc's given on 9-18-09 in R deltoid. Pt c/o R arm, shoulder and neck pain on 9-23-09. States pain increased a few days after shot given, was not immediate.				Y					Y	09/18/2009	09/23/2009	5	None	PVT	PVT			Diabetes; Rotator cuff injury			1						1	Musculoskeletal pain; Neck pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA259AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0358186	09/24/2009	OH	34.0	34		M	09/23/2009	Vaccine administered around 7:30 AM, pt. felt a welt forming on left side and within 2 hrs. had hives all over. Pt. was instructed to go to ER for evaluation. By time pt. arrived to ER pt. displayed; hot flashes, modling of neck area, hoarseness, swelling of throat, difficulty swallowing. In ER given Epinephrine, BENADRYL and sent home with prednisone prescription.				Y					Y	09/22/2009	09/22/2009	0	None	OTH	PVT	No	No	Abnormal kidney development - removed 10 yrs. ago.			1						1	Dysphagia; Dysphonia; Hot flush; Pharyngeal oedema; Urticaria	FLU3~SANOFI PASTEUR~U3207AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358188	09/24/2009	NY	71.0	71		F	09/24/2009	Pt. developed erythematous, raised, pruritic, generalized rash on 9/22/09.  No change in diet, soap, meds can explain this.									N	09/21/2009	09/22/2009	1	None	PVT	OTH	SYNTHROID; PRAVASTATIN; LODRINE; baby asa; MVI	No	DAYPRO; PCN			1						1	Rash erythematous; Rash generalised; Rash pruritic	FLU3~SANOFI PASTEUR~U3209AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358190	09/24/2009	MN	21.0	21		M	09/24/2009	Paleness, sweating, loss of consciousness few seconds, nausea, vomiting. Last about 5 min total.									Y	09/23/2009	09/23/2009	0		OTH	UNK						1						1	Hyperhidrosis; Loss of consciousness; Nausea; Pallor; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA281AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0358192	09/24/2009	MI	62.0	62		F	09/24/2009	Markedly swollen area at site of injection almost immediately, then next AM woke up with vascular patches on extremities/face, ears. Very, very itchy-worsening.				Y						09/15/2009	09/16/2009	1	Pt has had 1 course of PREDNISONE taper and 2 IM inj. of CELESTONE. Rx given today.	PVT	OTH			Allergy to CODEINE, lactose intol.			1						1	Injection site swelling; Pruritus; Vasculitic rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P2~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0358194	09/24/2009	NY	68.0	68		F	09/24/2009	Received flu shot in right deltoid and PNEUMOVAX in left deltoid. Approx. 5 min. after receiving vaccines, she developed severe right arm pain, radiated then to chest and then down whole right side. Pain resolved within 5-10 minutes. Sent to E.D. via ambulance for further evaluation.				Y					Y	09/23/2009	09/23/2009	0	None	PVT	OTH	Trazodone; Lovastatin; Atenolol; Metformin		VIOXX			1						1	Chest pain; Pain; Pain in extremity	FLU3~SANOFI PASTEUR~U3209A~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0632Y~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358195	09/24/2009	MN	9.0	9		M	09/14/2009	Vaccines administered right deltoid 9/11/09. 9/12/09 developed red indurated area. Office visit on 9/14/09-induration approx. 3 cm in diameter, skin pink, no infection.									Y	09/11/2009	09/12/2009	1	None	PVT	UNK		None	None			1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U3200AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB32DA~1~IM~LA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~0865Y~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0358197	09/24/2009	NE	50.0	50		F	09/21/2009	Headache, dizziness, naseua, fever, food stayed in stomach for 24 hours, chills, hot flashed, muscle aches, fatigue no reactions prior to 2007. However 2007, 2008, 2009 same reaction-2007 worse, 2008 not as bad, 2009 moderate.									Y	09/17/2009	09/17/2009	0		PVT	PVT			NSAIDS (all); pollens; weeds, grasses, trees	2007~Influenza (Seasonal) (no brand name)~UN~48.00~Patient|2008~Influenza (Seasonal) (no brand name)~UN~49.00~Patient		1						1	Chills; Dizziness; Dyspepsia; Fatigue; Headache; Hot flush; Myalgia; Nausea; Pyrexia; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U3202AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358198	09/24/2009	DE	40.0	40		F	09/17/2009	Vaccine given 11 am, had exacerbation of asthma at 4pm requiring rescue inhaler, resolved after 30-60 min. No other problems									Y	09/14/2009	09/14/2009	0	none	PUB	PUB			Asthma, seasonal allergies			1						1	Asthma	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA454CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0358199	09/24/2009	IL	79.0	79		F	09/17/2009	Swelling tongue-sore throat-swollen glands-neck began about 20 hours after shot-lasted 5 days.									Y	09/04/2009	09/05/2009	1		UNK	UNK			PEN.			1						1	Local swelling; Lymphadenopathy; Oropharyngeal pain; Swollen tongue	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358201	09/24/2009	TN	13.0	13		F	09/21/2009	Subsequent to vaccination, patient had fever, sore throat arthralgias.  She was taken to the Emergency Room & tested negative for flu A, B, H, N.				Y					U	09/17/2009	09/18/2009	1	Negative test for flu A, B. H, N1	OTH	PUB	None	None	None			1						1	Arthralgia; Influenza serology negative; Oropharyngeal pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P2~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0358202	09/24/2009	AZ	72.0	72		F	09/18/2009	Nausea, headache, aching muscles and bones, sleepiness, slight fever.									Y	09/11/2009	09/11/2009	0		OTH	UNK						1						1	Bone pain; Headache; Myalgia; Nausea; Pain; Pyrexia; Somnolence	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358205	09/24/2009	GA	12.0	12		F		Student complained with chest pains 2 hours after receiving FLUMIST at school based flu clinic.				Y					Y	09/16/2009	09/16/2009	0	Lab work and chest X-ray	OTH	PVT	TYLENOL; MOTRIN - because of chest pain.	None	None			1						1	Chest X-ray; Chest pain; Laboratory test	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0358206	09/24/2009	WI	85.0	85		F	09/20/2009	Pt had dizziness, sweating, vision problems the day after the flu shot was administered (09/10/09). Pt was perfectly ok on the day they called (09/15/09). Asked pt to see the doctor.									Y	09/09/2009	09/10/2009	1		OTH	OTH		None	None			1						1	Dizziness; Hyperhidrosis; Visual impairment	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358207	09/24/2009	IN	88.0	88		F	09/18/2009	Patient received FLUVIRIN at 14:15 on 9/17/09. Called on 9/18/09 to report she had dizziness and shortness of breath. Told her son to take her to see physician.				Y					U	09/17/2009	09/17/2009	0		OTH	UNK		None				1						1	Dizziness; Dyspnoea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97849P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0358208	09/24/2009	OH	68.0	68		F	09/11/2009	No itching, burning @ injection site. Site is red & swollen, warm to touch, pt worked out in yard all day, day after receiving vaccine.									U	09/09/2009				OTH	OTH						1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358210	09/24/2009	IL	25.0	25		F	09/17/2009	4:00 pm 9/17 pt calls and described a rash on left arm, tingling in both hands and feet, and generalized itching. Advised pt to take 50 mg BENADRYL. Seek help at ER if not better or worse. MD was called early morning, did not hear back as of 4:00pm 9/17.									Y	09/16/2009	09/17/2009	1		UNK	UNK						1						1	Paraesthesia; Pruritus generalised; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358211	09/24/2009	NC	15.0	15		F	09/23/2009	Information has been received from a medical assistant concerning a 16 year old female patient with pertinent medical history reported as none and drug reactions or allergies reported as none who on 02-JUN-2008 was vaccinated with a first dose of GARDASIL. On 31-JUL-2008 she received a second dose of GARDASIL (lot #660553/0070X). On 11-DEC-2008 she received third dose of GARDASIL (lot #660553/0070X). Concomitant therapy included hormonal contraceptives (unspecified). On 18-JUN-2009, the patient went to the emergency room with a pulmonary embolism and was admitted to the hospital. The patient had been placed on COUMADIN. On an unspecified date the patient recovered from the pulmonary embolism (PE). Follow up information has been received via telephone call from a licensed practical nurse who reported that on an unspecified date, the patient was placed on oral contraceptive (name not available) for heavy menses. On 02-JUN-2008 the patient received HAVRIX (unspecified) (lot # AHAVB264CA) and MENACTRA (lot # U2623AA) in addition to first dose of GARDASIL. On 31-JUL-2008 no other vaccines were given. On 11-DEC-2008 she received HAVRIX (unspecified) (lot # AHAVB291CA) and FLUZONE (lot # U2083AA) in addition to third dose of GARDASIL. On 18-JUN-2009 the patient presented to the emergency room with chest and back pain. Chest computed axial tomography showed multiple PEs in both lower lobes and the patient was hospitalized. The patient was started on heparin drip, oral contraceptive was discontinued ( patient told never to resume it again); switched from heparin to LOVENOX injections. On 22-JUN-2009 the patient was discharged, the patient was placed on oral COUMADIN. At the time of discharge the patient was able to resume all previous activities. Chart did not show if the event was considered life threatening. No further information is available.  9/29/09 ER records received DOS 6/18/09. Assessment: R/O Pulmonary Embolism. Patient presents with sharp pains (L) rib area midside up to (L) shoulder. Worsens with deep breath, movement. Birth control pills. Transfer to higher level facility recommended. 12/10/09 DC summary and Hospital records received for DOS 06/19/09-06-22/09. Pt presented with constant chest pain at rest . Consult  with pediatric hematology: treated with Heparin protocol then transitioned to Lovenox in order to intitiate Coumadin after discharge. All birth control pills stopped. Discharged home stable. DC DX: pulmonary emboli				Y	Y	4			Y	12/11/2008	06/18/2009	189	chest computed axial 06/18?/09, multiple PEs in both lower lobes. 9/29/09 ER records received DOS 6/18/09. LABS and DIAGNOSTICS: CBC - RBC 4.07 X10^3/UL (L) RDW 11.3% (L) GR 64.6% (H) LY 2.4% (L) MO 10.2% (H). CHEM - Chloride 109 MMOL/L (H). Urine - Cloudy, Leukocytes trace, WBC present, Epithelial present, Bacteria (3+). D Dimer 677.0 ng/mL (H). Chest X-ray - negative. 12/10/09 Diagnostics: CT scan: multiple pulmonary emboli in the right lower segmental B 4 bifurcation, both lower lid subsegmental branches, likely developing infarcts in the peripheral inferior left lobe Labs: CBC, BMP normal; clotting studies normal,	OTH	OTH	hormonal contraceptives.  9/29/09 ER records received DOS 6/18/09. Tubes in ears.	Heavy periods	PMH: Tubes in ears. 12/10/09 Medical records received w/PMH: NKDA;heavy menses, on birth control pills.		WAES0909USA02180	1						1	Back pain; Chest pain; Computerised tomogram thorax abnormal; Pulmonary embolism	FLU3~SANOFI PASTEUR~U2083AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB291CA~2~UN~UN~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~0070X~3~UN~UN~HPV (GARDASIL)~1	USA	Hospitalisation	Influenza
0358214	09/24/2009		67.0			F	09/23/2009	Information has been received from a Registered nurse, concerning a 67 year old female with no known drug allergies, who on 16-SEP-2009 was vaccinated with a 0.5 mL dose of PNEUMOVAX 23 (lot# 662842/1296X) intramuscularly into the left arm. Concomitant therapy included a dose of influenza virus vaccine (unspecified). On the same day, the patient experienced fingers tingling, on the left arm and then pain that went up to elbow and moved up to the whole arm. The patient's pain scale was 10 out of 10. The patient was unable to use the left arm. They also had nausea. The patient went to an unspecified walk in clinic in the morning. The patient was given IV REGLAN, DILAUDID and a 3rd unspecified medication that was considered by the nurse to be intervention to prevent serious criteria. At the time of reporting the patient had not recovered. Fingers tingling, pain that went up to the elbow and nausea were considered to be disabling by the reporting nurse because the patient could not move her arm. Upon internal review the fingers tingling, pain that went up to the elbow and nausea were determined to be other important medical events. This is one of several reports from the same source. Additional information has been requested.				Y				Y	N	09/16/2009	09/16/2009	0	Unknown	OTH	OTH			Unknown		WAES0909USA02373	1						1	Injected limb mobility decreased; Nausea; Pain in extremity; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1296X~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Disabling	Influenza
0358216	09/24/2009					F	09/23/2009	A female patient, with a history of ulcerative Proctitis diagnosed at age 52, received a subcutaneous injection of Influenza vaccine (manufacturer and lot number not reported). She was taking Sulfasalazine, Mercaptopurine, and intermittent steroids concomitantly, and her ulcerative Proctitis has been in remission for approximately nine months. Within hours of vaccination, the patient developed bloody diarrhoea and abdominal pain. She had very active ulcerative colitis with ulceration, friability and exudate, and recurrent bilateral uveitis. She was hospitalized, and treated with corticotrophin and tapering PREDNISONE. Symptoms improved, but did not resolve. Mercaptopurine and steroid doses were increased. One year after diagnosis, the patient underwent a total colectomy with ileoanal pouch anastamosis. She experienced intermittent pouchitis for one year before her pouch and ileum appeared normal. The patient noted that she had experienced a milder exacerbation of ulcerative colitis in the past following receipt of Influenza vaccine.					Y				Y					UNK	UNK	Sulfasalazine; Mercaptopurine; Steroids		History of ulcerative proctitis. Previous flu shot had also been followed by mild exacerbation of ulcerative colitis.	Ulcerative C~Vaccine not specified (no brand name)~UN~0.00~Patient	200903905	1						1	Abdominal pain; Colectomy; Colitis ulcerative; Condition aggravated; Diarrhoea haemorrhagic; Incorrect route of drug administration; Intestinal anastomosis; Pouchitis; Uveitis	FLUX~UNKNOWN MANUFACTURER~~UNK~SC~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0358218	09/24/2009	OR	50.0	50		F	09/21/2009	Moderately severe Laryngospasm 1 hr after vaccination.  Rx with EPI in ER.				Y					Y	09/17/2009	09/17/2009	0		OTH	UNK						1						1	Laryngospasm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA448BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0358219	09/24/2009	TN	30.0	30		F	09/18/2009	Immediately after shot, got lightheaded and dizzy.									Y	09/18/2009	09/18/2009	0		OTH	PVT						1						1	Dizziness; Immediate post-injection reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97849P1~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358222	09/24/2009	TX	5.0	5		F	09/21/2009	No adverse event.										09/19/2009			None	PVT	PVT	Novolin N Penfill, Novolog FlexpenSC	None	Diabetes Type I, Tonsillar Hypertrophy, Allergy to Keflex.			1						1	No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~500709P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0358223	09/24/2009	MN	14.0	14		M	09/23/2009	Patient was given AFLURIA preservative free vaccine that only indicated for 18 years or older.									Y	09/17/2009	09/17/2009	0		OTH	PVT	No	No	Unknown			1						1	Inappropriate schedule of drug administration; No adverse event	FLU3~CSL LIMITED~07249111A~1~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358226	09/24/2009	NY	25.0	25		F	09/24/2009	Site of injection; itchy, rash, spreading 5 minutes after injection ( flu) - Throat itchy, feeling  starting to close approx 1/2 hr after injection - Epinephrine 0.3 sc given (R) arm at 9:40 AM									Y	09/24/2009	09/24/2009	0		OTH	PVT	None	None	Seasonal allergies			1						1	Injection site pruritus; Injection site rash; Throat irritation; Throat tightness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~86030~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358230	09/24/2009	TN	29.0	29		F	09/17/2009	Fever 103.1, felt sluggish, myalgias symptoms + 2 days.  Treatment - OTC TYLENOL.				Y					Y	09/14/2009	09/14/2009	0	None	PVT	PVT	TOPAMAX;  Depo Provera;  CLARITIN; M Vitamins	None	Migraines;  Allergies			1						1	Myalgia; Pyrexia; Sluggishness	FLU3~CSL LIMITED~07949111A~1~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0358231	09/24/2009	IL	57.0	57		F	09/24/2009	Pain. Had trouble lifting arm and started right away. Came back to pharmacy 2nd day of pain. Has not gone away.				Y					N	09/22/2009	09/22/2009	0		OTH	PVT	Unknown	No	No			1						1	Mobility decreased; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0358232	09/24/2009	IL	68.0	68		F	09/21/2009	Red bumps underside of fingers of both hands that were itchy. Noticed the symptoms the night of 9/18/2009 - Flu vaccine was administered 9/17/09										09/17/2009	09/18/2009	1		OTH	UNK						1						1	Rash erythematous; Rash papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358234	09/24/2009	MO	70.0	70		F	09/24/2009	Patient had tingling in fingers, arm, and lips after receiving FLUVIRIN. Came back off and on for about a day and a half. Patient received shot on a Saturday 12:00 and by Monday morning was feeling much better and symptoms were gone. States she has had the flu shot before but never had these side effects.									Y	09/19/2009	09/19/2009	0		OTH	PVT	PREMPRO; zolpidem	None	None			1						1	No reaction on previous exposure to drug; Paraesthesia; Paraesthesia oral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358235	09/24/2009	ME	34.0	34		F	09/24/2009	Erythema & edema of upper arm, left. Onset within hours of injection.				Y						09/21/2009	09/21/2009	0	None	PVT	PVT		None	AODM; Milk intolerance			1						1	Cow's milk intolerance; Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U3208AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1163X~2~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358237	09/24/2009	LA	15.0	15		F	09/24/2009	Thursday, Sept. 24, 2009 at or about 1:20 p.m. a telephone call was received at clinic from the mother of patient stating the patient was complaining of difficulty breathing since FluMist administration.  Instructed parent to take patient to the nearest emergency room for further evaluation.				Y					U	09/23/2009	09/24/2009	1		OTH	PUB			Penicillin			1						1	Dyspnoea	FLUN3~MEDIMMUNE VACCINES, INC.~500688P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0229X~UNK~UN~RA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0358238	09/24/2009	IA	51.0	51		F	09/24/2009	Sore arm and bruised slightly at the site of injection.									U	09/22/2009	09/23/2009	1		OTH	UNK		None	None			1						1	Injection site haematoma; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~978392P2~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358240	09/24/2009	VA	35.0	35		U	09/24/2009	Started with a cough within an hour and a half after the vaccine. Felt as if my throat was closing and became a little difficult to breathe. Next day woke up to bloodshot eyes, and body aches. No more throat issues though. Two days later - better one hip joint still hurts - feel a little light headed but otherwise ok									Y	09/22/2009	09/22/2009	0		PVT	UNK		no	no			1						1	Arthralgia; Cough; Dizziness; Dyspnoea; Ocular hyperaemia; Pain; Throat tightness	FLU3~SANOFI PASTEUR~43212AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358242	09/24/2009	MI	42.0	42		F	09/24/2009	Tired, HA, nauseated, felt like I was coming down with the flu.  Resolved within 24 hours.  OTC Tylenol.									Y	09/18/2009	09/18/2009	0	None	PUB	UNK	None	None	None			1						1	Fatigue; Headache; Influenza like illness; Nausea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~96032 3P~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358243	09/24/2009	NY	22.0	22		F	09/24/2009	Received vaccine 9/18/09 at 11:30am At 7pm she reported significant bodyaches on on left side (vaccine was given left deltoid) from neck to knee. 10/10 pain, weakness. Seen 9/22/09 pain persists 7/10 diffucult to turn neck pain to touch over left side of back. Exan WNL with noted pain. TX NSSAIDS									U	09/18/2009	09/18/2009	0		PVT	PUB	ocp, singulair, allegra d	denies	seasonal allergies			1						1	Asthenia; Mobility decreased; Pain	FLU3~SANOFI PASTEUR~U320CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358244	09/24/2009	MI	48.0	48		F	09/24/2009	Tired, nauseated,desire to sleep, under arm lymph nodes tender, could not function for 3 days. OTC Rx and rest									Y	09/18/2009	09/18/2009	0	None	PUB	UNK		None				1						1	Activities of daily living impaired; Axillary pain; Fatigue; Lymph node pain; Nausea; Somnolence	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~96032 3P~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358245	09/24/2009	NY	41.0	41		F	09/24/2009	Soreness, redness 4.5x7cm, warmth at injection site.									Y	09/22/2009	09/24/2009	2	N/A	PUB	PVT	Nexium; Prenatal vitamins	None	None			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~96031 1P~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358246	09/24/2009	CT	49.0	39		F	09/24/2009	Vaccine received at approximately 1000 hrs on 09/22/2009.  Arm ached initially (muscle type ache)with slight redness at injection site.  On 09/23/2009 at approximately 0945 hrs, severe sensation of total body ice cold, antecubital and behind neck felt extremely hot, moderate nausea.  At 1145 shaking with mild diaphoresis but temperature not taken - still nauseated.  Two Ibuprophen taken.  Headache began.  Rested until 1400 hrs.  Shaking stopped, headache persisted. Fever approximately 99.4F at 1500 hrs.  Gradually, symptoms subsided with all but a mild headache by 0900 hrs. on 09/24/2009.  No urticaria, itching or neurological signs i.e. numbness or loss of function.  Did not seek medical care.									Y	09/22/2009	09/23/2009	1	None	PUB	PUB	None	None	None. Mild allergy symptoms in spring	None~ ()~NULL~~In Patient		1						1	Body temperature decreased; Feeling cold; Headache; Hyperhidrosis; Injection site erythema; Myalgia; Nausea; Pain in extremity; Pyrexia; Skin warm; Tremor	FLU3~CSL LIMITED~01549211A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358247	09/24/2009	MI	46.0	46		F	09/24/2009	FACIAL SWELLING, HANDS, GIVEN FLU VACCINE ON 9/23/09 10:00 A.M.  WILL BE 23 OBSERVATION AT HOSPITAL FOR TREATMENT.  9/29/09 ED/Hospital records received DOS 9/24/09 to 9/25/09. Assessment Angioedema, Adverse reaction to influenza vaccine. Patient presents with swelling of face, lips and hands. Swelling of cheeks, lips, eyes.				Y					U	09/23/2009	09/23/2009	0	TO BE DETERMAINED AT HOSPITAL. 9/29/09 ED/Hospital records received DOS 9/24/09 to 9/25/09. LABS and DIAGNOSTICS: CHEM - CO2 22 MMO/L (L). CBC - MCV 78.9 FL (L) MCH 26.4 PG (L). Chest X-ray - Normal.	UNK	UNK	ZOLOFT 150 MG, CIPRO 250 MG 10 DAY COURSE, STARTED 8-25-09	ALLERGIC RHINITIS, SINUS PRESSURE, NO TEMP, HEADACHES	SULFA, BEE STINGS. 9/29/09 ED/Hospital records received DOS 9/24/09 to 9/25/09.Depressive anxiety disorder. Laparosopic cholecystectomy, arthroscopy (R) knee, tubal ligation, right breast biopsy.			1						1	Oedema peripheral; Swelling face	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA482BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0358248	09/24/2009	VT	25.0	25		F	09/24/2009	pt broke outwith severe hives. Benedryl for treatment.				Y					Y	09/21/2009	09/22/2009	1		PVT	PVT	depoprovera	none	none			1						1	Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA25AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0358252	09/24/2009	NE	86.0	86		M	09/24/2009	Veteran received Pneumococcal about 9:30 AM on 9-16-09 in right arm and Influenza in the left arm.  He awoke from sleep at 2:30 AM on 9-17-09 and his arm was red, swollen, hard, and painful to touch.  He later fainted.  He was taken to hospital by ambulance where he was treated and released.				Y					Y	09/16/2009	09/17/2009	1		UNK	UNK	Just his regular medicines.  Lisinopril, Aspirin, Niacin, Simvastatin, Triamcinolone crm					1						1	Erythema; Induration; Oedema peripheral; Pain in extremity; Syncope; Erythema; Inappropriate schedule of drug administration; Induration; Oedema peripheral; Pain in extremity; Syncope	FLU3~CSL LIMITED~07549111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~0504Y~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0504Y~UNK~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0358253	09/24/2009	MI	15.0	15		F	09/24/2009	UPON DOUBLE CHECKING PRESCRIPTIONS PER PHARMACY POLICY I DISCOVER THAT AFLURIA WAS GIVEN TO A 15 YEARS OLD CHILD. AFLURIA IS INDICATED FOR 18 YEARS AND ABOVE. PATIENT DID NOT COMPLAIN ABOUT ANY THING FOR THE 20 MINUTES SHE WAITED AFTER THE SHOT. BUT I AM REPORTING AS REQUIRED.									Y	09/18/2009				UNK	UNK						1						1	Inappropriate schedule of drug administration	FLU3~CSL LIMITED~05849111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358254	09/24/2009	MD	53.0	53		F	09/24/2009	Pt began to have numbness in throat and gums.  Tingling of extremities.									Y	09/24/2009	09/24/2009	0		UNK	PUB	None	No	None			1						1	Hypoaesthesia oral; Paraesthesia	FLU3~SANOFI PASTEUR~U3201AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358255	09/24/2009	IL	30.0	30		F	09/24/2009	Pt received vaccine 09/10/09 from employee health. On 09/14/09 pt developed diffuse arthralgias, rash, fever and SOB. She presented to her PCP where medrol dose pak was prescribed with some relief. On 09/21/09 she was unable to get out of bed on her own power due to severe arthralgias. She reported to her PCP who diagnosed her with serum sickness.				Y					Y	09/10/2009	09/14/2009	4	Outside provider	UNK	PUB						1						1	Arthralgia; Dyspnoea; Pyrexia; Rash; Serum sickness	FLU3~CSL LIMITED~07049111A~1~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0358256	09/24/2009	TX	49.0	49		F	09/24/2009	localized area of redness, warmth, and itching									U	09/22/2009	09/23/2009	1		PVT	UNK	none	none	none			1						1	Erythema; Feeling hot; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98441P1A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358257	09/24/2009	IL	59.0	59		F	09/24/2009	Pt received vaccine 09/18/09, that night pt reports very swollen inj site along w/ arthralgias along with myalgias. Pt took ibuprofen w/o any resolution of sx. Pt then reported to emloyee health and recieved medrol dose pak with resolution of systems.				Y					Y	09/18/2009	09/18/2009	0		UNK	PUB		None	none			1						1	Arthralgia; Injection site swelling; Myalgia; Myalgia	FLU3~CSL LIMITED~07049111a~UNK~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1|FLU3~CSL LIMITED~07049111A~UNK~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~2	USA	Emergency room visit	Influenza
0358258	09/24/2009	IL	25.0	25		F	09/24/2009	Patient complained of tingling/numbness/weakness of right arm, stated could not feel fingers or arm very well. Onset of symptoms approximately 3-5 minutes after administration of vaccine. Ice pack applied to right arm at site of injection, assessed and compared strength of hand grips bilaterally. Patient started feeling relief of symptoms after 10 minutes. Strength increased of right arm. Spoke with patient 9-24-09, states numbness and weakness gone, arm is just sore at site. Described soreness as normal reaction.									Y	09/23/2009	09/23/2009	0		PUB	PVT			5 months pregnant			1						1	Hypoaesthesia; Injection site pain; Muscular weakness; Paraesthesia	FLU3~CSL LIMITED~01449211a~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358260	09/24/2009	TX	9.0	9		M	09/24/2009	Pt receivied the Afluria Adult Influenza vaccine at approximately 1000 on 23 Sep 2009. Pt has had no adverse reactions. Mom states soreness at the site. Tylenol given.									U	09/23/2009				MIL	MIL	Flovent HFA, Montelukast, Albuterol Sulfate HFA, Pulmicort	none	asthma			1						1	Injection site pain; Wrong drug administered	FLU3~CSL LIMITED~06549111A~1~IM~RL~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358261	09/24/2009	FL	30.0	30		F	09/24/2009	CLIENT RECEIVED VACCINATION ON 9/17/09 AT 10AM. ON THE SAME DATE AT 10:15AM CLIENT STARTED HAVING BLURRED VISION. AT 10:20AM CLIENT FELT TONGUE WAS SWELLING AND NUMB. AT 10:30AM CLIENT FELT DIZZY. AT 10:40AM CLIENT WAS IN THE EMERGENCY ROOM. CLIENT RECEIEVED A DOSE OF THE EPI PEN, IV BENADRYL AND IV STERIODS. ON 9/18/09 AT 3PM CLIENT FELT FACE AND NECK BURNING, TONGUE CONTINUED TO BE NUMB AND CLIENT FOUND IT HARD TO SWALLOW AND ALSO HAD CHEST TIGHTNESS. CLIENT IS NOW UNDER AN ALLERGIST'S CARE. CLIENT STATES THAT SHE CONTINUES TO HAVE SYMPTOMS THAT APPEAR TO BECOME LESSER DAILY.				Y					N	09/17/2009	09/17/2009	0	CLIENT IS UNDER AN ALLERGIST'S CARE AT THIS TIME	PVT	UNK		NONE KNOWN	NONE KNOWN			1						1	Burning sensation; Chest discomfort; Dizziness; Dysphagia; Hypoaesthesia oral; Swollen tongue; Vision blurred	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA468CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0358264	09/24/2009	CA	40.0	40		F	09/24/2009	Approximately one half hour after immunization patient felt pain , muscle spasm and some numbness to left arm. Was seen next day (9/22/09) by PCP who ordered somma for muscle relaxant, Ibuprofen for discomfort, and a sling to limit movement. Returned next day to PCP who ordered continuation of treatment as well as a topical steroid cream. Patient states much relief from treatment but still uncomfortable.				Y					U	09/21/2009	09/21/2009	0	None	PUB	UNK	Unknown	None	Unknown			1						1	Hypoaesthesia; Muscle spasms; Pain in extremity	FLU3~SANOFI PASTEUR~U3202AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358266	09/24/2009	TX	4.0	4		F	09/24/2009	- approx 5 minutes after administration of the vaccines, patient had abrupt onset of facial and lip swelling, lethargy, paleness with perioral cyanosis, and tachypnea - epinephrine was administered SQ immediately and she was placed on 100% O2 by facemask and EMS was called - EMS arrived within 7 minutes and transported her to hospital; prior to arrival to EMS, patient was pale, and lethargic with occasional outbursts of agitation - she had impressive lip swelling, pale appearance and hives noted on upper thighs; she was drooling but there was no stridor - she had clear breath sounds - tachypnea and mild retractions were also noted; she was also tachycardic but this was noted approx 3 min after the administration of SQ epinephrine. - contact by ER - patient received another dose of epi in ER along with Benadryl and steroids - stable and doing well - BP a little low - considering PICU vs IMC admission.  10/1/09 ED records received DOS 9/24/09 to 9/25/09. Assessment: Acute Anaphylaxis. Patient developed immediate oral swelling, lip edema, and emesis. Presents with general weakness, decreased level of consciousness, lightheadedness, rapid respirations, coughing, wheezing. Pale, tired. Erythematous splotches legs. Observe overnight.				Y	Y	1			U	09/24/2009	09/24/2009	0	History of anaphylaxis and carried an epi pen - history of eczema and suspicious for asthma	UNK	UNK	Enalpril, ASA, Coreg; PRN:  albuterol, Epi-pen	eczema flare	Severe coarctation of aorta - in early infancy had 3 cardiac surgeries and suffered cardiac arrest - stable for past 3 years - has had previous serious allergic reaction of unknown etiology, followed by an allergist and carries an epi-pen, history of eczema and suspect asthma. 10/1/09 ED records received DOS 9/24/09 to 9/25/09. Unknown allergen. Congenital heart disease (Shone Syndrome), cardiac surgery. GERD. Strabismus.			1						1	Agitation; Cyanosis; Drooling; Hypotension; Intensive care; Lethargy; Lip swelling; Pallor; Swelling face; Tachycardia; Tachypnoea; Urticaria; Use of accessory respiratory muscles	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B116BA~1~IM~LL~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~U3177~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0765Y~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1001Y~2~SC~RL~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0358268	09/24/2009	CT	39.0	39		F	09/24/2009	Patient has a hypertensive reaction with a BP of 160/100 compared with her normal readings of 104/80. She experienced facial numbness and heart palpitations.									Y	09/21/2009	09/21/2009	0	Blood pressure readings	PUB	UNK		none	NONE reported			1						1	Hypertension; Hypoaesthesia facial; Palpitations	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~96035 2P~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358269	09/24/2009	CA	25.0	25		F	09/24/2009	pt. stated she had history of fainting with shots but had not occurred in over 10 years. After injection was complete pt. immediately stated she did not feel well and fainted in her chair. I was able to hold her for a few minutes and she never appeared to lose consciousness. She was sweaty, nausea, and cold. We moved her to the floor and elevated her feet with a cold towel on her face/head. Pt requested paramedics and they checked her out and said she was stable. Pt stayed in pharmacy for about 30 minutes until she went home. She was feeling better when she left.									Y	09/24/2009	09/24/2009	0		UNK	UNK	motrin	none	none	fainting~ ()~NULL~~In Patient		1						1	Feeling cold; Hyperhidrosis; Immediate post-injection reaction; Malaise; Nausea; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838p1~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358272	09/24/2009	RI	55.0	55		F	09/24/2009	Severe hoarseness; sore throat, treated with Sudafed, Aleve, and Vitamin C 500mg, plenty of fluids. I still have symptoms present after one week, expectorating yellow secretions.									N	09/16/2009	09/18/2009	2	none	PVT	PUB	Fish oil 1200mg, Calcium 600mg, Vitamin D 1000mg,Vitamin E 400, Asa 81mg, Red yeast rice 600mg, Centrum silver, Evening Primrose Oil 1200mg, Vitamin C 500mg, Alprazolam .025mg as needed.	None	None			1						1	Dysphonia; Oropharyngeal pain; Sputum purulent	FLU3~PFIZER\WYETH~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLU-IMUNE)~1	USA		Influenza
0358273	09/24/2009	FL	13.0	13		F	09/24/2009	Headache, then blurry vision, numbness in right hand the right side of the face, numbness on right side of the body. Slurred speech. No treatment. Blurred vision lasted 5 minutes,numbness went away in about 1 hour. 10/6/09 PCP medical records neuro and ophth consults DOS 2/17/09 to 9/22/09. Assessment: Transient visual loss, headache, migraine, hyperopia. Patient presents with blurred vision, floaters. Tingling in hand, shoulder, facial area, down leg, felt that she would pass out. Lightheaded, nauseous. Numbness right side. Oral contraceptives.				Y					Y	09/08/2009	09/22/2009	14	Primary care doctor visit the same day. Visited Neurologist the next day. Eye doctor 2nd day and had a MRI and MRA.	UNK	UNK	birth control	no	Headaches. 10/6/09 PCP medical records neuro and ophth consults DOS 2/17/09 to 9/22/09. Chronic headaches with photophobia. Lightheaded. CT Brain - Maxillary sinus changes. MRI Brain - Abnormal, consistent with migraines, cerebellar tonsillar ectopy, right maxillary sinusitus. Stomach aches, knee pain, growing pains. Right shoulder lower than left. Moody, labile, angry spells. Menses irregular. Dermatophagoides IGE 84.60 kU/L (H). Walnut Immunoglobulin E 336 kU/L (H).			1						1	Dysarthria; Headache; Hypoaesthesia; Hypoaesthesia facial; Nuclear magnetic resonance imaging; Vision blurred	FLUX~SANOFI PASTEUR~U3211AA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~0672Y~2~IM~RA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0358277	09/24/2009	MI	60.0	60		F	09/24/2009	Eyes bloodshot within 1 hour after vaccinatio, loose stools, headache, temp 98, green drainage from both eyes									Y	09/17/2009	09/17/2009	0	NONE	PUB	UNK	None	none	none			1						1	Diarrhoea; Eye discharge; Headache; Ocular hyperaemia	FLU3~SANOFI PASTEUR~U3196AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358281	09/24/2009	WI	43.0	43		F	09/24/2009	Arm showed redness and swelling approximately 4 inches below the injection site.  Patient was seen by physician and diagnosed with an allergy to a component of the flu vaccine									Y	09/19/2009	09/21/2009	2		UNK	UNK	Alprazolam, Erythromycin Topical, Zolpidem, Oxybutynin, Naproxen	None	None			1						1	Allergy to vaccine; Erythema; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358282	09/24/2009	FL	46.0			F	09/24/2009	approximately 30 minutes after adminstration of seasonal flu vaccine increasingly severe radiating pain in deltoid to neck and ear began, facial flushing, swelling of both orbits.Went to onsite emergency dept. and was treated with IV benadryl, solumedrol, and tagament.									Y					PUB	PVT			enviromental allergies			1						1	Ear pain; Eye swelling; Flushing; Neck pain; Pain in extremity; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUR482BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0358283	09/24/2009	IL	28.0	28		F	09/24/2009	9/15/09 - Received flu vaccine   9/18/09 - Began with a severe headache.   9/19/09 - Woke up with Left sided facial drooping. Went to the ER				Y					U	09/15/2009	09/18/2009	3		PVT	PVT	None	None, other than facial drooping and headache.	None			1						1	Facial palsy; Headache	FLU3~CSL LIMITED~01449211A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0358284	09/24/2009	NC				F	09/24/2009	Rednees on skin started Tuesday 09-22-09.  Pt was given the vaccine on 09-21-09.  Red splotchy area approximately 4 inches in diameter around injection site.				Y					U	09/21/2009	09/22/2009	1	Upon examaination her doctor prescribed Keflex 500mg TID for 10 days	UNK	PVT	Crestor, metoprolol, amlodipine, NTG					1						1	Erythema; Injection site erythema; Injection site rash; Rash macular	FLU3~SANOFI PASTEUR~U3192AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358285	09/24/2009	TX	28.0	28		F	09/24/2009	Flu vaccine given on 09-22-2009 at 2 p.m., hives and swelling on hands started at 9 pm on 9-22-09 until 7 p.m. on 09-23-09. Benadryl was taken orally three times. No trouble after last dose.									Y	09/22/2009	09/23/2009	1	none	UNK	PUB	Tylenol 1000 mg prior to vaccine	none	has asthma, allergic to augmentin			1						1	Oedema peripheral; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98433P1~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358286	09/24/2009	MA	65.0	65		F	09/24/2009	Within a few minutes after administration,there was profound swelling  left deltoid.  Ice pack applied Benadryl 50mg po given at 10:30am. She returned to work.  I called her at 2:15pm she felt well though deltoid was still swollen. Her plan is to call her MD which she had done that day.  She has a allergy to mangoes.										09/23/2009	09/23/2009	0		PUB	UNK		None	H/O Severe reactions to mangos			1						1	Injection site swelling	FLU3~SANOFI PASTEUR~U3188AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358287	09/24/2009	NC	52.0	52		F	09/24/2009	Had flu vaccine administered at pharmacy and have had trouble with my arm ever since. For the first week it was painful to sleep, my arm was extremely sore. As of date I can not fully extend my arm. Went back to the clinic today and was told to go to my primary doctor. He started me on anti-inflammatory medicine. The person given the shot could have administered it in a weird place in the arm. I noticed that it was given at a higher spot than normal. My arm when I move it certain ways almost feels like a pinched nerve. I went in before the shot fine and did nothing to cause pain in the arm. I also have gotten a flu shot every year with no adverse effects. This is day 13. Will see if the anti-inflammatory helps. This is most unusal for me and like I stated...I have never had anything like this happen after a seasonal flu shot. Thanks for your time.										09/11/2009	09/11/2009	0		UNK	UNK		none	none			1						1	Injected limb mobility decreased; No reaction on previous exposure to drug; Pain in extremity; Sleep disorder	FLU3~SANOFI PASTEUR~U3209AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358289	09/24/2009	VA	4.0	4		M	09/24/2009	Broke out in a measles type rash within 24 hours of receiving vaccines and became irritable with itching, but no fever.Mother called to report symptoms the next day, and took the patient to the pediatrician 09/24/09 who said it looked like a measles reaction, but stated they don't usually occur for a week after the shot. Said if pt. developes a fever over the next few days, she would consider it a viral infection.										09/22/2009	09/23/2009	1		PUB	PUB		None	Downs Syndrome/Multiple Cardiac problems			1						1	Irritability; Pruritus; Rash morbilliform; Irritability; Rash morbilliform	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B137AA~5~IM~RA~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~U3211AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0449Y~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1009Y~2~SC~LA~VARICELLA (VARIVAX)~1|DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B137AA~5~IM~RA~DTAP + IPV (KINRIX)~2|FLU3~SANOFI PASTEUR~U3211AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|MMR~MERCK & CO. INC.~0449Y~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~2|VARCEL~MERCK & CO. INC.~1009Y~2~SC~LA~VARICELLA (VARIVAX)~2	USA		Influenza
0358290	09/24/2009	TN	81.0	81		M	09/24/2009	Patient received flu vaccine around 11:30 am.  Patient left clinic and went to the store with his wife where he began to feel light headed and trembly.  He reported slight parasthesia in left leg.  Patient and wife left store and immediately came back to our clinic.  Arrived here again at approximately 12:00 noon.  At this time symptoms still existed, but were milder.  Pt stated I just don't feel right.  Pt advised to return home and rest, take Benadryl for reaction treatment and Aleve for the aches.  Wife will monitor.  We followed up with a phone call at 4:00 pm and pt states he is doing much better.  He had taken Aleve and Benadryl and symptoms are beginning to resolve.									Y	09/24/2009	09/24/2009	0	None	PVT	PVT	Lisinopril 5 mg daily; HCTZ 25 mg daily; Pravachol 20 mg daily; Aspirin 81 mg daily; Vitamin C	None noted	Allergies:  Penicillin, Desonide, Ketoconazole; Medical conditions:  Inflammed seb keratosis; verrucca vulgaris; actinic keratosis; Hypertension;  High cholesterol			1						1	Dizziness; Feeling abnormal; Paraesthesia; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358291	09/24/2009	NY	39.0	39		F	09/24/2009	Employee states a raised itching rash on forehead with slight brown coloration along hairline and eyebrows .  Employee unsure of when itching started pre or post vaccine immunization									U	09/22/2009	09/24/2009	2		UNK	UNK	Levoxyl		Questionable history of latex allergy/sensitivity , sensitivity to gloves(latex). latex titer was reported negative, historically .			1						1	Rash pruritic; Skin discolouration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA470AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0358292	09/24/2009	AK	31.0	31		M	09/24/2009	Red throat, swollen uvula				Y					U	09/23/2009	09/24/2009	1	Throat culture,rapid strep	UNK	PVT		None	None			1						1	Culture throat; Enlarged uvula; Pharyngeal erythema; Streptococcal identification test	FLU3~SANOFI PASTEUR~V3198AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358296	09/24/2009	RI	11.0	11		M	09/24/2009	Syncopal episode approximately 5 minutes after administration of vaccine. No injury sustained. No sustained loc. Vital signs stable. Lied down for a bit, drank some juice and regained strength and left office after 20 mins. Did have breakfast this morning. Phone f/u in the evening--child still not feeling completely well--h/a, nausea. No fever. No vomiting. Recommended Tylenol dose.									U	09/24/2009	09/24/2009	0	None	PVT	PUB	None	None	None			1						1	Headache; Malaise; Nausea; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~96031~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|MNQ~SANOFI PASTEUR~U3027AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B047AA~1~IM~RA~TDAP (BOOSTRIX)~1	USA		Influenza
0358297	09/24/2009	CT	29.0	28		F	09/24/2009	Patient described arm feeling tingling and not able to grip items with right hand. As time progressed, patient stated forearm felt cold and fingers were numb									U	09/24/2009	09/24/2009	0		UNK	UNK	none known	none known	none known			1						1	Grip strength decreased; Hypoaesthesia; Paraesthesia; Peripheral coldness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838p1~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358301	09/24/2009	OH	49.0	49		M	09/24/2009	This case was reported by a healthcare professional and described the occurrence of stopped breathing in a 49-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 21 September 2009 between 08:15 and 08:30, the subject received a dose of FLULAVAL (unknown). On 21 September 2009, within 15 to 30 minutes of vaccination with FLULAVAL, the subject experienced stopped breathing, passed out, seizure and nonspecific reaction. The healthcare professional reported a subject experienced a reaction in the office after receiving FLULAVAL. The subject passed out, had a seizure and stopped breathing. The rescue squad was called and he was taken to the emergency room. It is unknown what type of treatment he received, although all events resolved that day. The healthcare professional considered the events were life threatening. On 21 September 2009, the events were resolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL.			Y	Y					Y	09/21/2009	09/21/2009	0	UNK	OTH	OTH		Unknown	Concomitant medications and relevant medical history were unknown. It was unknown if adverse events were reported with previous vaccinations. It was unknown if the subject had previously received influenza vaccinations or experienced adverse events.		A0808728A	1						1	Convulsion; Loss of consciousness; Nonspecific reaction; Respiratory arrest	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA262AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening	Influenza
0358302	09/24/2009	NY	29.0	29		F	09/24/2009	Achy body, tingling sensation from armpit to forearm. Forearm warm to the touch.									U	09/22/2009	09/22/2009	0		OTH	PVT	Unknown					1						1	Pain; Paraesthesia; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2A~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358303	09/24/2009	NC	28.0	28		F	09/24/2009	Within 12 hours of shot, experienced uncommon fatigue, drowsiness. Within 24 hours of shot, began to itch and had a few whelps on my arms. Initially assumed it was a reaction to a mosquito or spider bite. A few hrs. later entire body covered in whelps with tremendous itching till I applied hydrocortisone cream and took BENADRYL. 48 hrs. after shot, whelps still severe.									N	09/22/2009	09/23/2009	1	Have not seen a physician at this point	OTH	UNK	None	None	None	High pitched crying~Measles + Mumps + Rubella (no brand name)~UN~0.00~Patient		1						1	Fatigue; Pruritus; Somnolence; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0358305	09/24/2009	CA	72.0	72		M	09/24/2009	Pt had PNEUMOVAX and FLUZONE admin. on 9/22/09 and developed redness and swelling to entire left upper arm 9/24/09. Seen by his physician and placed on antibiotic.									Y	09/22/2009	09/24/2009	2	None	OTH	OTH	Placed on trimethoprim-sulfamethoxazole 160-800 mg 1 tab BID x 14	No	NKDA			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U3196AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1161X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358306	09/24/2009	TX	84.0	84		F	09/24/2009	- Hard to walk -  Pain on right side thigh/hip.									U	09/01/2009				UNK	PUB		None reported	None			1						1	Arthralgia; Gait disturbance; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA259AA~2~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0358309	09/24/2009	WI				U		Developed annular plaque - hot red + raised.  8 cm x 10 cm.  Reaction occurred within 3 hours.										09/22/2009	09/22/2009	0	None	OTH	OTH	Insulin	None	Type 2 diabetic;  Insulin dependent;  Raynaud's			1						1	Erythema; Skin plaque; Skin swelling; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA257CA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0358310	09/24/2009	CA	52.0	52		F	09/24/2009	Pain, redness, swelling at injection site. Prescribed CIPRO, ANAPROXIN									N	09/14/2009	09/21/2009	7	None	OTH	PVT		None				1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U3190AH~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358311	09/24/2009	CA	51.0	51		M	09/24/2009	Skin itching, reddened skin whelps, increased pulse, skin flushing, treatment BENEDRYL 2.5 mg by mouth.									Y	08/24/2009	08/24/2009	0	None	OTH	PVT	None	None				1						1	Erythema; Flushing; Heart rate increased; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358312	09/24/2009	NH	41.0	41		M	09/24/2009	Lt arm cellulitis - severity 7/10 edema + pain from shoulder to elbow.  Immunizations given 9/23 5:45 PM.  Swelling noted 9 PM - increasing in severity until seen by PCP 9/24 9 AM.  Treated with AUGMENTIN 8.75-12.5 x 7 days.				Y					U	09/23/2009	09/23/2009	0		PVT	PVT	COZAAR;  ACTOS;  GLUCOTROL;  Meals;  JANUMET;  PREDNISONE;  NAPROXYN;  Food;  Wrist brace;  One Touch Ultra Test Strips;  Daily vitamin;  Fish Oil;  ASACOL;  ASPIRIN	None	Diabetes;  Ulcerative colitis;  Elevated liver enzymes; Hypertension;  Hepatitis B			1						1	Cellulitis; Injection site oedema; Injection site pain; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA454CA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1162X~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358313	09/24/2009	IL	11.0	11		M	09/24/2009	Red, swollen cellulitis upper arm RA.									Y	09/21/2009	09/22/2009	1	Cellulitis	PVT	PVT	None	None	Healthy			1						1	Injection site cellulitis; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U3176FA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U3014AA~1~UN~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0358314	09/24/2009	MA	51.0	51		F	09/23/2009	I advised nurse to administer FLUMIST to this patient, after admin. she noted she is 51; and thus >49yoa.									Y	09/23/2009				PVT	PVT		None	None			1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500709~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0358317	09/24/2009	MI	0.52	0	.5	F	09/16/2009	None stated										09/11/2009				UNK	UNK						1						1	No adverse event	DTAP~SANOFI PASTEUR~C3224AA~3~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT3171CA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB608BA~3~IM~RL~HEP B (ENGERIX-B)~1|IPV~SANOFI PASTEUR~C3224AA~3~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|PNC~PFIZER\WYETH~D57303~3~IM~RL~PNEUMO (PREVNAR)~1|RV1~GLAXOSMITHKLINE BIOLOGICALS~D180Y~3~PO~MO~ROTAVIRUS (ROTARIX)~1	USA		Influenza
0358328	09/24/2009	SC	76.0	76		F	09/16/2009	Hard area around injection site - Uncomfortable - Went to ER.				Y					Y	09/13/2009	09/14/2009	1	None	OTH	PVT	PROTONIX; DITROPAN, ER 10 mg	None	GERD; Over active bladder			1						1	Injection site discomfort; Injection site induration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848PIC~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0037Y~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358329	09/25/2009	GA	22.0	22		M	09/25/2009	He received the H1N1 shot on Monday 9-21-09. He called me last night to tell me that he had a severe stomach ache all day today - tried to eat and about 11:00 pm ended up throwing up and was very concerned because there was a significant amount of blood in the matter he threw up.  He went to the watch and they took him to the emergency room where they gave him one day of sick in quarters.  I don't know what the diagnosis was, but usually you are pretty ill to get SIQ. My son never has stomach aches.  Rarely throws up. Never has thrown up blood.   He was not running a fever, but the whole event scared him enough that he asked me what he thought he should do because they don't like people to cry sick.   I told him to make them take him to the emergency room.				Y					U	09/22/2009	09/23/2009	1		MIL	MIL			allergy to sulfa drugs			1						1	Abdominal pain upper; Haematemesis; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0358330	09/25/2009	NC	55.0	55		F	09/25/2009	Headache, throat closing up, chest heavy and tight, hives, pins and needles feeling, uncontrollable coughing, runny nose, watery eyes, SOB, got shot at 11 am, s/s at 2pm. Ambulance called, went to ER, received benadryl and prednisone.				Y					Y	09/22/2009	09/22/2009	0	none performed	UNK	UNK	none	None	none	none~ ()~~0.00~Patient|none~ ()~~0.00~Sibling|none~ ()~~0.00~Sibling		1						1	Chest discomfort; Cough; Dyspnoea; Headache; Lacrimation increased; Paraesthesia; Rhinorrhoea; Throat tightness; Urticaria	FLU3~SANOFI PASTEUR~U3200AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358331	09/25/2009	MS	49.0	49		M	09/25/2009	Received vaccines @ 0915, felt bad @ 1600, skin hurt @ 2000(took tylenol), awakened @ midnight with chills, shakes, and temp of 101.8 F(took tylenol).  This morining temperature of 99.4.									Y	09/24/2009	09/24/2009	0		MIL	MIL	N/A	N/A	N/A			1						1	Body temperature increased; Chills; Malaise; Pain of skin; Tremor	ANTH~EMERGENT BIOSOLUTIONS~FAV202~6~IM~RA~ANTHRAX (BIOTHRAX)~1|FLU3~CSL LIMITED~08049111A~7+~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358332	09/25/2009	TX	31.0	31		F	09/25/2009	Fever of 101 degrees, body aches, nausea, vomiting, abdominal cramps two hours after vaccination				Y					Y	09/23/2009	09/23/2009	0		PUB	PUB	Singulair 10mg daily, Simbalta 30mg 2 tablets daily, Warfarin 5mg 1 tab Monday, Wednesday, Thursday and Friday and two tablets on Saturday and Sunday, Effexor XR 37.5mg 2 capsules daily, Lunesta 3mg at HS, Abilify 15mg daily, Thyroid daily,	None	DVT			1						1	Abdominal pain; Nausea; Pain; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U3211AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358335	09/25/2009	NJ	82.0	82		M	09/25/2009	Dizziness, light-headedness, unsteadiness in walking, paleness, nausea.				Y					U	09/23/2009	09/25/2009	2	Conducted by Dr.  Blood tests, EKG, blood-pressure measurement, normal patient exam by doctor.  Results unknown.	UNK	UNK		None				1						1	Balance disorder; Blood test; Dizziness; Electrocardiogram; Nausea; Pallor	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0358336	09/25/2009	IA	4.0	4		M	09/24/2009	Pt had onset of red macular rash with pruritis within 24 hours of receiving HAVRIX and FLUMIST. Rash associated with significant pruritis but not associated with any symptoms of respiratory distress or mouth/tongue swelling. Rash treated with BENADRYL and resolved by 72-96 hrs.									Y	09/17/2009	09/18/2009	1	Rash on chest, shoulder, stomach, back	PVT	PVT	MIRALAX; BENEFIBER	None	Constipation, feeding difficulties (aversions)			1						1	Pruritus; Rash erythematous; Rash macular	FLUN3~MEDIMMUNE VACCINES, INC.~500711P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB357AA~1~IM~RL~HEP A (HAVRIX)~1	USA		Influenza
0358337	09/25/2009	VA	46.0	46		F	09/24/2009	Pt reports pain in left upper arm/shoulder since administration of vaccine in superior deltoid about finger width below acromion worsening in last 48 hours with difficulty raising L arm above shoulder and sensation of heaviness in L arm.									U	09/15/2009	09/15/2009	0		PUB	OTH	Ocp's; PULMICORT; ALBUTEROL		Asthma			1						1	Injected limb mobility decreased; Injection site pain; Musculoskeletal pain; Sensation of heaviness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA449BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0358338	09/25/2009	PA	59.0	59		F	09/25/2009	L upper arm-irregular red, warm patch & mod. increase COPD related wheezes.				Y					U	09/23/2009	09/24/2009	1		PVT	PVT		-	COPD			1						1	Condition aggravated; Injection site erythema; Injection site warmth; Wheezing	FLU3~SANOFI PASTEUR~U3204AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358339	09/25/2009	LA	55.0	55		F	09/25/2009	Stiff neck/sore arm/ shoulder.									Y	09/15/2009	09/16/2009	1		OTH	OTH						1						1	Musculoskeletal pain; Musculoskeletal stiffness; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358340	09/25/2009	TN	11.0	11		M	09/25/2009	Patient presented to office with L thigh area red, swollen, and hot. Area size approx. 3 in. x 4 in. and spreading into groin area. Instructed to apply ice packs off and on and ATARAX was prescribed.									U	09/23/2009			None	PVT	PVT	VYVANSE	No	ADD, eczema			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3201AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2930AA~1~IM~LL~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C3057AA~1~IM~LL~TDAP (ADACEL)~1	USA		Influenza
0358341	09/25/2009	IL	43.0	43		F	09/22/2009	Lt deltoid injection-10 min. later pain shot to hand and lt thumb numb. Injection site noted in std location, belly of deltoid.									Y	09/22/2009	09/22/2009	0	Time-24 hours later reports no symptoms	PVT	OTH	None	None	Allergic to PCN, sulfa			1						1	Hypoaesthesia; Pain; Pain in extremity	FLU3~CSL LIMITED~07849111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358342	09/25/2009	IL	56.0	56		F	09/25/2009	Pt. started itch on palms and soles of feet, progressed to scalp and torso; took BENADRYL about 12:00/13:00-itching improved. Itching returns without BENADRYL. Pt. states condition is much better.									Y	09/21/2009	09/21/2009	0		PUB	PUB	HYDROCHLOROTHIAZIDE	None	AMPICILLIN			1						1	Pruritus	FLU3~SANOFI PASTEUR~03187AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358343	09/25/2009	TX	28.0	28		F	09/24/2009	Presented 9/24/09, 2:22, eyes bloodshot, red. Hasn't eaten since yesterday. HA started after vaccine and nausea, bloodshot eyes start couple of hours after. Eyes were burning initially and arm itching a little. Had it before last year the flu and pneumonia and previous years.				Y					N	09/23/2009	09/23/2009	0		OTH	PVT	AMBIEN; BUSPAR; fluoxetine	No	Anxiety, post traumatic stress dress			1						1	Decreased appetite; Eye irritation; Headache; Nausea; Ocular hyperaemia; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97884P1~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0358344	09/25/2009	IA	4.0	4		M	09/24/2009	Patient had considerable cough and sneezing after dose was given on 9/16/2009. Within 24 hours patient developed low grade fever. By 48 hours after dose, patient developed headache, stomach ache and vomiting ( no further fever). Patient had intermittent emesis for 24-36 hours then recovered.									Y	09/16/2009	09/17/2009	1	None	PVT	PVT	Multivitamin	Recent Viral illness and LSOM	None			1						1	Abdominal pain upper; Cough; Headache; Pyrexia; Sneezing; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500688P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0358345	09/25/2009	AR	29.0	29		M	09/24/2009	Tingling in left leg at 7:15pm. Tingling in left leg and arm; sleepiness at 8:15pm.									Y	09/24/2009	09/24/2009	0		OTH	OTH	None					1						1	Paraesthesia; Somnolence	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358346	09/25/2009	NY	72.0	72		F	09/23/2009	I received Flu vaccine 2 hrs after my throat started to close up. I develop Hives over Body. Headache & Joint Pains & Vomiting.				Y					N	09/14/2009	09/14/2009	0	Severe Allergic Reaction	PUB	UNK		Hives; Throat Closure; Joint Pain	Diabetes Mellitus; HTN; Asthma; Certain food allergies-trees			1						1	Arthralgia; Condition aggravated; Headache; Hypersensitivity; Throat tightness; Urticaria; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0358348	09/25/2009	NY	24.0	24		F	09/25/2009	Pt experience facial edema, eye swelling. No SOB, no difficulty swallowing. Tx at hospital Ed with BENADRYL and PREDNISONE.				Y					Y	09/24/2009	09/24/2009	0	None	PUB	PVT	None	None reported	None reported			1						1	Eye swelling; Face oedema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA259AA~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0358349	09/25/2009	OH	55.0	55		F	09/24/2009	Within 5 min. tingling injection site, right arm, spread to entire arm, red area above wrist. Tingle and tightness spread to head, arms, legs.				Y					Y	09/24/2009	09/24/2009	0	CT of head	OTH	OTH		No	Mitral valve prolapse; pituitary small tumor			1						1	Computerised tomogram; Erythema; Injection site reaction; Paraesthesia; Skin tightness	FLU3~CSL LIMITED~06349111A~1~UN~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0358350	09/25/2009	PA	55.0	55		F	09/20/2009	Patient received PNEUMOVAX and FLUZONE injections on 9/16/09. States that on 9/17 she noted swelling, erythema and pain in arm below injection site. Rash and tenderness now approx. 3  below injection area. Pt given MEDROL dose pack with instructions for warm compresses, NSAIDS and elevation and instructions to follow up if no improvement or worsening occurs in 24-48 hours.									U	09/16/2009	09/17/2009	1		OTH	PVT		None	HTN, dyslipidemia			1						1	Injection site erythema; Injection site pain; Injection site rash; Injection site swelling	FLU3~SANOFI PASTEUR~U3199AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1124X~2~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358351	09/25/2009	KS	68.0	68		F	09/22/2009	Pt left arm from the shoulder to the elbow has become swollen, red, and hot to touch.									U	09/21/2009	09/21/2009	0		PVT	UNK		None	None			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3191AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0632Y~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358357	09/25/2009	PA	10.0	10		M	09/25/2009	9/258/09 09:30 Telephone report from school nurse states this student did receive FLUMIST nasal spray yesterday. Today school nurse states that the child is complaining that he is having difficulty in swallowing and that there is some tongue swelling. Speech does not seem to be impaired. No apparent problems breathing. Referred to PMD.									U	09/24/2009	09/25/2009	1		OTH	PUB	None known	None known	None known			1						1	Dysphagia; Swollen tongue	FLUN3~MEDIMMUNE VACCINES, INC.~500705P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0358358	09/25/2009	NJ	72.0	72		F	09/24/2009	Large red, circular area where injection was given; also painful and itchy at site. Doctor was contacted and cold compress and TYLENOL was prescribed. Patient still complaining of pain and redness after two days.									U	09/23/2009	09/23/2009	0		UNK	UNK						1						1	Injection site erythema; Injection site pain; Injection site pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841PXA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1162X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358359	09/25/2009	NJ	67.0	67		F	09/24/2009	Information has been received from a registered nurse concerning a 65 year old female patient with hyperlipidemia and hypertension and a history of herpes zoster who on 14-SEP-2009 morning was vaccinated with the first dose of PNEUMOVAX (lot# 663486/0507Y). Concomitant vaccine administered on the same day included influenza virus vaccine (unspecified) (manufacturer unknown) in the other arm. By the evening of 14-SEP-2009 the patient could not move her arm. It was extremely swollen and painful. The patient was seen in the office and was given SOLUMEDRIL as it looked like an anaphylactoid reaction. She was shaking and was taken to an unspecified hospital. The patient was hospitalized. The other arm administered the influenza virus vaccine (unspecified) had no reaction. The nurse stated that the patient developed more of a reaction than you would expect. The office would like a lot check on lot# 663486/0507Y. Could not moving her arm, extremely swollen arm, extremely painful arm, anaphylactoid reaction and shaking were considered to be disabling. Additional information has been requested. This is one of several reports from the same source. A lot check has been initiated. 11/17/09:  Hospital Records received for dates of service 11/14/09 to 11/16/09. Dx: Allergic reaction.  Assessment:  Pt. states that immediately upon receiving the pneumonococcal vaccine she felt pain in her shoulder and then became SOB.  She also received the Influenza vaccine in the other arm. Pulse oxymetry was 83%.  Given Solumedrol in MD office.  Shoulder pain persisted and she presented to the ED and was admitted with shoulder pain bilaterally. Shoulder ROM limited due to discomfort.				Y	Y	3		Y	U	09/14/2009	09/14/2009	0	Unknown.  11/17/09:  Hospital Records received for dates of service 11/14/09 to 11/16/09. Labs and diagnostics: CXR-NAD.  WBC 13.3 (H), RBC 3.97 (L), Hgb 11.7 (L), Hct 35.7 (L),  MCHC 32.8 (L), Neut % 89.2 (H), Lymph % 4.8 (L), Eos % 0.1 (L), Neut # 11.8 (H), Lymph # 0.6 (L), Segs % 79 (H), Bands % 10 (H).  Glucose 127 (H).  MRI R Shoulder-Abnormal.	OTH	OTH		Hyperlipidaemia; Hypertension	Herpes zoster.  11/17/09:  Hospital Records received for dates of service 11/14/09 to 11/16/09. PMH:  HTN, CAD, Osteopenia, Rosacea, Hyperlipidemia.		WAES0909USA03167	1						1	Anaphylactoid reaction; Movement disorder; Oedema peripheral; Pain in extremity; Tremor	FLUX~SANOFI PASTEUR~U3199AA~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0507Y~1~UN~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation,Disabling	Influenza
0358368	09/25/2009	WA	10.0	10		M	09/25/2009	Injections of tDap and Flu shot were received at approx.  2pm.  Mom describes patient complaining of pain at site of injection at bedtime, so she layed with him.  Soon after, he became disoriented and scared.  Asked, Mom, where am I?  He also had blurry vision.  No fevers.  No seizures.  Patient was taken to ER.				Y					Y	09/23/2009	09/23/2009	0	none	PVT	PVT	none	None	None			1						1	Disorientation; Fear; Injection site pain; Vision blurred	FLU3~SANOFI PASTEUR~u3201aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~ac52b04~1~IM~LA~TDAP (BOOSTRIX)~1	USA	Emergency room visit	Influenza
0358369	09/25/2009	LA	44.0	44		M	09/25/2009	Severe pain deep to injection site right deltoid shortly after injection, worsened over next several hours and unable to abduct arm without pain. Limited ROM arm, shooting pains in area.  No edema erythema induration.  No discrete paralysis. Has had multiple flu shots as well as other vaccines in military and never had reaction.									N	09/14/2009	09/14/2009	0	No imaging or labs yet.  Refer to physical therapy. Consider MRI or CT scan and possibly orthopedic consult if continues.	MIL	MIL	NA	NA	NA			1						1	Injected limb mobility decreased; Injection site pain; No reaction on previous exposure to drug; Pain	FLU3~SANOFI PASTEUR~U3176AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358370	09/25/2009	AZ	53.0	53		F	09/25/2009	Patient had a large bruise on her arm at administration site.				Y					Y	09/03/2009	09/03/2009	0	None	PVT	PVT	Estrace, Ativan	None	Chronic Leukemia, Basal Cell Carcinoma, history of melanoma, excema, history of hypothyroidism			1						1	Injection site haematoma	FLU3~SANOFI PASTEUR~U3211aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358372	09/25/2009	AZ	4.0	4		M	09/25/2009	redness and swelling to R thigh Dx: Cellulitis. treatment Keflex250/5ml 7cc TID									Y	09/21/2009	09/21/2009	0	None	PVT	PUB		none	none			1						1	Cellulitis; Injection site erythema; Injection site swelling	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~ac20b115aa~UNK~IM~RL~DTAP + IPV (KINRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500683p~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~MERCK & CO. INC.~0564y~UNK~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1001y~UNK~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0358375	09/25/2009	MD	11.0	11		F	09/25/2009	Fever 101.9, Vomiting, Lethargy, achy, headache, dizzy. Symptoms started about 7 hours after vaccination on 9/24/09									U	09/24/2009	09/25/2009	1	None at this time, but patient is still sick	PVT	UNK						1						1	Dizziness; Headache; Lethargy; Pain; Pyrexia; Vomiting	FLUX~SANOFI PASTEUR~U3211AA~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0358379	09/25/2009	AZ	51.0	51		F	09/25/2009	PAIN IN LEFT ARM BEGAN WITHIN 1/2 HR. OF RECEIVING FLU SHOT.  PAIN INTENSIFIED AND WENT TO THE HIP AND LEFT LEG AND AROUND THE NECK.  PAIN WAS INTESE FOR 5 HOURS AND I AM STILL HAVING PAIN IN MY HIP,ARM, LEG & NECK APPROXIMATELY 17 HOURS LATER.										09/24/2009	09/24/2009	0		UNK	UNK						1						1	Arthralgia; Neck pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0358382	09/25/2009	MO	0.59	0	.6	F	09/25/2009	Patient febrile 09/25/2009 mother took patient to hospital emergency room. While a patient in the emergency room under care of Dr. patient had a febrile seizure.									Y	09/22/2009	09/25/2009	3		UNK	UNK		none				1						1	Febrile convulsion; Pyrexia	DTAPIPVHIB~SANOFI PASTEUR~C3429AA~UNK~IM~~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~UT3178FA~UNK~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~~UNK~IM~~HEP B (RECOMBIVAX HB)~1|PPV~MERCK & CO. INC.~D61920~UNK~IM~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358383	09/25/2009	NY	71.0	71		F	09/25/2009	Evening after vaccine, pt felt pain in Left arm above elbow to shoulder.  Next day, pt noted 3 diameter red area on upper arm but below vaccine site.  It was warm, painful and grew larger. She developed another, smaller red area under her arm above elbow. Rash slightly raised, nonitchy.  On 09/24 pt saw PA who gave her antihistamine and stated that she'd had a reaction.				Y					Y	09/22/2009	09/22/2009	0		PUB	UNK	lisinopril, amitriptylline 25 mg, vitamins, estrace	no	high blood pressure			1						1	Erythema; Injection site pain; Pain in extremity; Rash; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUAH70BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1435X~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358391	09/25/2009	OH	2.0	2	.1	M	09/25/2009	Pt received Influenza vaccine IM on Tuesday September 22, 2009.  That evening pt had leg pain causing pt to limp and parents noticed swelling and redness.  The symptoms have persisted.  Pt was seen By Dr. in office on 9/25/09 and has large local swelling and erythema.  Dr feels it is from the vaccine pt received.									N	09/22/2009	09/22/2009	0	None	UNK	UNK		Pt had mouth sores at time of flu injection, afebrile.	Asthma, Rt Hydrocele, Dermatitis, Umbilical Hernia			1						1	Gait disturbance; Injection site erythema; Injection site swelling; Pain in extremity	FLU3~SANOFI PASTEUR~UT3178CA~4~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358393	09/25/2009	VA	15.0	15		F	09/25/2009	Extreme swelling, redness of the injection site. Headache, High Fever (101.6 - 102 degrees), Neck stiffness, Chills, Dizziness, Nausea				Y					U	09/21/2009	09/22/2009	1		UNK	UNK		Tineas corpus	Penicillan			1						1	Chills; Dizziness; Headache; Injection site erythema; Injection site swelling; Musculoskeletal stiffness; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0358394	09/25/2009	OR	2.0	2	.6	F	09/25/2009	Parent called - described significant behavioral changes over 36-48 hours after flu vaccine - aggressive, fussy, much more significant than baseline - no fever- no tenderness at injection site - mom also said uri present over the week									Y	09/23/2009	09/23/2009	0		PVT	PVT	fluoride supplement	uri	reactive airway disease			1						1	Aggression; Irritability; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~ut3171da~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358395	09/25/2009	UT	6.0	6		M	09/25/2009	He got the flu shot in his L arm and that evening his upper arm got red, swollen, and hot to touch, he has also had fevers off and on since he got it.  I have been giving him Motrin and benedryl, as of now its  still the same his arm has not gone down, as far as swollen, red, and hot.  He got the same reaction last year when given the flu shot.									N	09/24/2009	09/24/2009	0		PVT	PVT				same reaction~Influenza (Seasonal) (no brand name)~1~5.90~In Patient		1						1	Erythema; Oedema peripheral; Pyrexia; Skin warm; Vaccine positive rechallenge	FLUX~UNKNOWN MANUFACTURER~dont know it~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0358430	09/25/2009	MS	68.0	68		F	09/24/2009	1. Was hospitalized 9/16/08. 2. Hospitalized 01/30/09. 3. Hospitalized for GBS - 02/06/09.  12/11/09 DC summary for DOS 09/16/08  09/20/08: Final DX: R upper lobe pneumonia. Pt c/o malaise, decreased appetite, fever, weakness bilaterally.  On examination: leukocytosis.  Tx: antibiotics.  Pneumonia resolving.  Pt discharged home.    12/11/09 ED note for DOS 01/30/09 DX: paresthesias. Pt c/o numbness BLE and BUE. Decreased sensation hands and feet. Pt discharged with cardiology f/u.  12/03/09 DC summary for DOS 02/06/09  02/10/09. Final DX: GBS. Pt c/o weakness and tingling of U and L extremities. Pt had transthoracic echocardiogram:  moderate enlarged LA, mild L inferior hypertrophy, mild enlarged RA. Also, LP performed.  12/03/09 DC summary for DOS 02/13/09  02/16/09 Final DX: GBS. Pt readmitted for further observation of GBS.  On 02/14/09, Pt had unsteady gait.  Pt's GBS was slowly progressing, but there were no health concerns during the hospital stay.  Pt was stable and able to ambulate with cane.  Pt discharged home with OT/PT f/u.				Y	Y	11			U	10/21/2008			Bone Mineral Density test  Labs and DX studies: T 102F, CXR: R upper lobe infiltrate; CSF lumbar puncture: 135 protein mg/dl (H), 90 glucose mg/dl (H), 1 white blood cell, 0 red cells and no growth. LP, sigmoidoscopy findings normal. Cr 2.5 mg/dl (H). Echocardiogram. LP, EMG abnormal. Stress ECG normal.	PUB	PUB	Cyclosporine; Lisinopril; Metoprolol; Ranitidine; Amitriptyline; Hydralazine; Amlodipine; Docusate sodium; CALTRATE; Metipranolol; ZETIA; furosemide; potassium chlor; SLOW MAG; BAYER aspirin 81 mg; pravastatin; prednisone; multivitamin; LAN		Heart transplant; eye loss  PMH: cardiac transplant in 1994, diabetes, HTN, chronic kidney disease, diabetes, GERD, hypercholesterolemia, gout, L eye no vision, L artificial eye. Allergies: NKDA.			1						1	Bone densitometry; Guillain-Barre syndrome	FLU3~SANOFI PASTEUR~U2747AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0358432	09/25/2009	NE	34.0	34		F	09/25/2009	Patient described tingling in the face on the same side as vaccine.									U	09/25/2009	09/25/2009	0		OTH	OTH	PCN	Unknown	Unknown			1						1	Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~9784P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358433	09/25/2009	VA	27.0	27		M	09/24/2009	O2 Sat 93%. Hives, wheezing and swelling, bradycardia EPI x 2 then transported via EMS to staff and hospital ER.				Y					Y	09/23/2009	09/23/2009	0		MIL	MIL						1						1	Bradycardia; Swelling; Urticaria; Wheezing	FLUN3~MEDIMMUNE VACCINES, INC.~500693P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AHABB160AA~1~IM~LA~HEP A + HEP B (TWINRIX)~1|YF~SANOFI PASTEUR~UF583AA~UNK~SC~LA~YELLOW FEVER (YF-VAX)~1	USA	Emergency room visit	Influenza
0358434	09/25/2009	VA	2.0	2	.1	U	09/25/2009	Mom reports pt had continued vomiting from 0700-1100 with fever of 103.0F. Mom states by late afternoon pt acting & eating WNL.									Y	09/17/2009	09/18/2009	1		MIL	MIL		No	No			1						1	Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500693P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB350BA~2~UN~LL~HEP A (HAVRIX)~1	USA		Influenza
0358435	09/25/2009	RI	59.0			F		9/21/09 Received TC from client-received AFLURIA yesterday-stiffness in neck today. Questions if flu shot related. Advised call MD-putting ice on site, sore and took TYLENOL.									U					PUB	UNK						1						1	Musculoskeletal stiffness; Pain	FLU3~CSL LIMITED~02349211a~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358436	09/25/2009	RI				F		9/21 Received AFLURIA yesterday-now has cellulitis at site. Same thing happened last year-she called MD-on KEFLEX 4 x day. 9/24 Doing better-to see MD today for a recheck appt.									Y					PUB	UNK						1						1	Injection site cellulitis; Vaccine positive rechallenge	FLU3~CSL LIMITED~02349211A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358440	09/25/2009	TN	49.0	49		F	09/25/2009	Patient reported redness, swelling, pain in left arm to pharmacist on duty the evening of 9/24/09. She was vaccinated with PNEUMOVAX in that arm. Pharmacist on duty advised cold compresses, BENADRYL. On 9/25/09 patient reported continuing pain, swelling, redness and fever in arm. She said she would watch it over the weekend and follow up with her MD if not better.										09/24/2009	09/24/2009	0		UNK	UNK		None reported	None reported			1						1	Erythema; Oedema peripheral; Pain in extremity; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P1~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0632Y~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358441	09/25/2009	CO	11.0	11		F	09/27/2009	I was vaccinating family of 5. It turned out youngest needed FLUMIST. I filled 4 out of 5 syringes. I picked up 3 filled  1 empty syringe. Patient was injected with empty syringe. I saw patient next day no adverse reaction.										09/19/2009	09/19/2009	0		UNK	UNK		None	None Known			1						1	Incorrect dose administered; No adverse event	FLU3~SANOFI PASTEUR~U3190AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358442	09/25/2009	OR	64.0	64		F	09/25/2009	Patient said her knee got inflamed and went to her doctor and doctor said it was probably related to the Flu shot.									U	09/22/2009	09/25/2009	3		OTH	OTH	Not known	Not known	Not known			1						1	Inflammation	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848PIC~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358443	09/25/2009	MT	30.0	30		F	09/24/2009	Received FLUZONE at approx. 07:00. 08:00 dry cough progressing to audible wheezing with increasing severity. Treated with 25 mg BENADRYL IM with symptom improvement.				Y					Y	09/24/2009	09/24/2009	0	None	PUB	PVT	Birth control pills	None	Mild asthma, seasonal allergies (moderate)			1						1	Cough; Wheezing	FLU3~SANOFI PASTEUR~U3211AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358445	09/25/2009	TX	29.0	29		U		Very inflamed at site of injection. Had to go to Dr.-told inj. site had abscessed, given CEPHALEXIN.				Y					Y	09/22/2009	09/23/2009	1		OTH	PVT	None listed	No	None			1						1	Injection site abscess; Injection site inflammation	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA257AA~1~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0358446	09/25/2009	TX	29.0	29		F	09/25/2009	Upon giving vaccine employee states she felt chills, then approximately 15 mins later she felt chills again. At 1845 she felt hot, flushed cheeks, and diaphoresis, then cold chills approx 15 min. episodes each on 9/25/2009 symptoms lasting approx 2 hrs and 15 min. Tem 103 degrees with hallucinations approx 1 degree stopped after fever brake. Emesis x4  states it was stomach and then dry because approx 10 - 15 min. She applied cold towels to head/body. Awoke next morning with dizziness and muscle pain. IBUPROFEN taken for muscle pain relief.									Y	09/24/2009	09/24/2009	0	None	OTH	PVT	None	None	None			1						1	Body temperature increased; Chills; Dizziness; Feeling hot; Feeling of body temperature change; Flushing; Hallucination; Hyperhidrosis; Myalgia; Vomiting	FLU3~CSL LIMITED~07849111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358447	09/25/2009	WA	23.0	23		F	09/27/2009	Chest ache/tightness x 10 min. immediately after vaccine admin.									Y	09/06/2009	09/06/2009	0	None	OTH	UNK	Unknown	None	History of palpitations			1						1	Chest discomfort; Chest pain; Immediate post-injection reaction	FLU3~SANOFI PASTEUR~U3196AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358448	09/25/2009	WA	53.0	53		F	09/27/2009	Right after shot as patient was at car; patient experienced transient chest ache which went away. Next morning upon awakening, severe chest ache/tightness took place x 1/2 day.									Y	09/06/2009	09/06/2009	0	None	OTH	OTH		None	History of mitral valve prolapse			1						1	Chest discomfort; Chest pain	FLU3~SANOFI PASTEUR~U3196AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358449	09/25/2009	AL	12.0	12		F	09/25/2009	Local inflammation reaction. Area of induration, redness, heat is about 3 inches diameter.									U	09/22/2009	09/23/2009	1	None	PUB	OTH		Influenza-no fever since 9/19/09				1						1	Erythema; Induration; Inflammation; Local reaction; Skin warm	FLU3~SANOFI PASTEUR~97842P2~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0806Y~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0358452	09/25/2009	MA	18.0	18		F	09/26/2009	After 4-6 hours of getting FLUVIRIN vaccine. Pt had following symtoms/RXN. All over body rash, Hives, swelling at injection site. Body aches, neck & back stiffness, dizziness nausea & diarrhea.									N	09/25/2009	09/25/2009	0	N/A	UNK	OTH	None	None	N/A			1						1	Diarrhoea; Dizziness; Injection site swelling; Musculoskeletal stiffness; Nausea; Pain; Rash generalised; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358453	09/25/2009	MI	80.0	80		F	09/25/2009	1:40 pm-slight bleeding @ injection site-stopped immediately, but rapid swelling 1/4-1/2 around; applied gentle pressure & ice-patient denied am discomfort & unconcerned. Sent ice home w/pt. 3pm called patient @ home-was fine, no swelling, nausea, soreness or bleeding.									Y	09/25/2009	09/25/2009	0	N/A	OTH	OTH	N/A	None				1						1	Injection site haemorrhage; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358454	09/25/2009	IL	43.0	43		F	09/02/2009	Injection site sore, pain in left shoulder radiating into neck. Headache after injection, gone after 12 hours.									U	09/01/2009	09/01/2009	0		OTH	PVT						1						1	Headache; Injection site pain; Musculoskeletal pain; Neck pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358456	09/25/2009	MN	82.0	82		F		Light headedness 2 hrs after appointment Dizzy. Symptoms gone by the next day.									Y	09/23/2009	09/23/2009	0		PVT	OTH	Norvasc 5mg, Lanoxin Qid 25, Donexpin 10mg, Atenolol 50mg, MaxiVision, Disinoprol 20 mg.	None	NKDA			1						1	Dizziness	FLU3~SANOFI PASTEUR~U3189AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358457	09/25/2009	CA	45.0	45		F	09/20/2009	Developed rash, oral paresthesias, itching rash swollen lips  foggy stuffy head Rash on lips and legs red blotches - pt relates she had milder re last yr. But didn't connect it to FLU vac until now. RX DECADIN, PREDNESONE, BENADRYL.				Y					Y	09/11/2009	09/11/2009	0	Anemia-Hgb/ 8.3/HCT 25.5	PVT	PVT	Unknown	None	Asthma, seasonal allergies			1						1	Feeling abnormal; Haematocrit decreased; Haemoglobin normal; Lip swelling; Nasal congestion; Paraesthesia oral; Rash; Rash macular; Rash pruritic; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U3174EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358458	09/25/2009	MN	48.0	48		F	09/25/2009	About 30-45 minutes after my shot, I noticed my speech was slurring. I was very tired and also saying words that did not apply to what I was talking about. The slurring was not constant.									Y	09/22/2009	09/22/2009	0		OTH	UNK		None	None			1						1	Dysarthria; Fatigue; Speech disorder	FLU3~SANOFI PASTEUR~U3207AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358459	09/25/2009	MI	81.0	81		F	09/23/2009	None									Y	09/21/2009	09/23/2009	2		OTH	OTH	Unknown	None	Unknown			1						1	No adverse event	FLU3~CSL LIMITED~05849111A~1~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358460	09/25/2009	MN	43.0	43		F	09/25/2009	Muscle ache, Joint pain, dizziness vision was blurry 2 hrs after receiving injection the symptoms started.									Y	09/22/2009				PVT	UNK		None	None			1						1	Arthralgia; Dizziness; Myalgia; Vision blurred	FLU3~SANOFI PASTEUR~U3202AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358461	09/25/2009	IL	67.0	67		F	09/23/2009	PATIENT CALLED 9/23/09 STATING SHE IS STILL IN EXCRUCIATING PAIN. SAID SHE WAS VERY PAINFUL ON ADMINISTRATION AND IS STILL VERY PAINFUL 2 WKS LATER.									U	09/09/2009	09/09/2009	0		OTH	UNK	Unknown	No	Unknown			1						1	Pain; Pain in extremity	FLU3~SANOFI PASTEUR~U3107AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358462	09/25/2009	MI	57.0	57		F	09/24/2009	Patient presented to Pharmacist approximately 1 hours after vaccination with red face, arms, & legs. RPh immediately administered 50mg diphenhydramine IM and monitored patient for next hour. The redness steadily decreased, patient went home. He called later to inform RPh that he was feeling much better.									Y	09/24/2009	09/24/2009	0		OTH	OTH	Unknown	None	Diabetes			1						1	Erythema	FLU3~CSL LIMITED~05849111A~1~UN~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358464	09/25/2009	TN	48.0	48		F	09/25/2009	No ADE after giving shot directly. Patient called from home stating hot feeling well, body aches, diarrhea, RPh/administrator explained couldn't get Flu from inactivated FLUVIRIN.									U	09/23/2009	09/23/2009	0		UNK	UNK	Clonzapam, buspirone, Xoprex, tussionex		Allergies: Sulfa, HC: asthma & other upper respiratory conditions.			1						1	Diarrhoea; Malaise; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358465	09/25/2009	RI	36.0	36		M	09/26/2009	Pain, redness, numbness and tingling the next day. Pt given MOBIC 15 mg 1 dly. Advised to apply ice and rest arm. No work 9-22-09 and 9-23-09.				Y					Y	09/21/2009	09/22/2009	1		PVT	PUB	DIOVAN 160 mg	No	Hypertension			1						1	Erythema; Hypoaesthesia; Pain; Paraesthesia	FLU3~CSL LIMITED~02649211A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0358466	09/25/2009	DE	34.0	34		F	09/25/2009	After patient received vaccine, patient (while still in chair) passed out. PT was out for more than 15 seconds. Patient woke up and was fine. Paramedics were called and they escorted her out of the store.									Y	09/25/2009	09/25/2009	0		OTH	PVT	Unknown	Fainting	Unknown			1						1	Loss of consciousness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358467	09/25/2009	CA	19.0	19		F	09/25/2009	Swollen and sore under arm pit are the same side FLU shot was given one day later									U	09/21/2009	09/22/2009	1		OTH	OTH						1						1	Axillary pain; Lymphadenopathy	FLU3~SANOFI PASTEUR~U3171AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358163	09/26/2009	CA	23.0	23		F	09/26/2009	After 3-4 minutes of receiving vaccine patient reported of dizziness. When try to help, patient refused any help to be given. Contacted patient's doctor and doctor said they will try to contact patient. Patient was in the store for 20-25 minutes walking around.									U	09/26/2009	09/26/2009	0		OTH	UNK		No				1						1	Dizziness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358396	09/26/2009	CA	41.0	41		F	09/25/2009	Chestpain									U	09/25/2009	09/25/2009	0		PUB	PUB	Pseudophedrine	no	ASTHMA			1						1	Chest pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P1~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358398	09/26/2009	FL	47.0	47		M	09/26/2009	Inflamed Lymph Node under the left armpit, injection was given IM into left arm.The swollen node feels like a golf ball and quite painful, it developed ( started hurting) the day after receiving the vaccination									N	09/22/2009	09/23/2009	1		PUB	UNK	Nexium 40mg QD, Oxycodone 5 mg Q4-6H prn pain, Dronabinol 5mg QHS.	Chronic back pain	Aspirin, NSAIDS, Cox2 Inhibitors.			1						1	Inflammation; Lymph node pain; Lymphadenopathy	FLU3~CSL LIMITED~01749211A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358400	09/26/2009	NY	0.51	0	.5	F	09/26/2009	30 minutes to 2 hours after shot: Swelling of left eye (eye completely shut), some hives on back, and swelling and redness of injection site (left leg). Day after shot: continued swelling of left eye (less severe) and some swelling of right eye.				Y					Y	09/25/2009	09/25/2009	0		UNK	UNK		cold symptoms	none			1						1	Eye swelling; Injection site erythema; Injection site swelling; Urticaria	DTP~UNKNOWN MANUFACTURER~~3~IM~UN~DTP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~1~IM~LL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEP~UNKNOWN MANUFACTURER~~3~IM~UN~HEP B (NO BRAND NAME)~1|OPV~UNKNOWN MANUFACTURER~~3~PO~MO~POLIO VIRUS, ORAL (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~3~IM~UN~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0358402	09/26/2009	SC	4.0	4		M	09/26/2009	Received Seasonal Influenza Vaccine at approximately 11:30 am, returned to clinic at 12:00 with reddish rash around mouth. Slight swelling inside lower lip. No difficulty breathing, no itching, no rash on any other body part. Refered to Private MD, called prior to leaving clinic and mom waiting on return call. Discussed with mom that if and shortness of breath or spreading of rash, to call 911 and seek Emergency care.				Y					U	09/26/2009	09/26/2009	0	N/A	UNK	UNK	None	No	none		SC0925	1						1	Lip swelling; Rash	FLU3~PFIZER\WYETH~U3209aa~2~IM~LA~INFLUENZA (SEASONAL) (FLUSHIELD)~1	USA	Emergency room visit	Influenza
0358403	09/26/2009	TX	70.0	70		F	09/26/2009	ABOURT 10-15 MINUTES AFTER RECEIVING FLUVIRIN AND ZOSTAVAX PT EXPERIENCED INCREASED HEART RATE WHICH LASTED ABOUT 30 MINUTES OR LESS.									Y	09/26/2009	09/26/2009	0		UNK	UNK		NONE	2 HEART ATTACKS			1						1	Heart rate increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARZOS~MERCK & CO. INC.~1554X~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0358404	09/26/2009	MN	9.0	9		M	09/26/2009	Patient laying down when shot was given. Approximately 2 minutes following vaccine administration patient layed back down and exhibited shaking/tremors with eyes rolling back.  Nurse reports patient appeared cyanotic and was not breathing for approximately1 minute.  Physician contacted.  Felt it may have been a vasovagal response.  Father stated the exact same thing happened last year.  Offered patient provider visit.  Family declined and patient ambulated out independently.									Y	09/26/2009	09/26/2009	0	None	PVT	PVT	None	None	Hyperopia/astigmatism	Fainting~Influenza (Seasonal) (Fluzone)~UN~8.00~In Patient		1						1	Cyanosis; Gaze palsy; Presyncope; Respiratory arrest; Tremor; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U3178AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358406	09/26/2009	IL	69.0	69		U	09/26/2009	IMM given on 09/09/2009 SQ Left posterior upper arm, tolerated well.  Patient reported 1-2 days later having a red raised rash (hives) to skin under breasts, around her waistline and right lateral hip.  Symptoms continued intermittently over 16 days with itching.  Patient returned to the TCC for evaluation, dx was urticaria and treated with zyrtec, benadryl and oral prednisone.									U	09/09/2009	09/11/2009	2		UNK	PVT	simvastatin; metoprolol; aspirin; trimtazide	none	sulfa, relafen			1						1	Pruritus; Rash erythematous; Urticaria	FLU3~SANOFI PASTEUR~U3191AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~0742Y~2~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0358408	09/26/2009	OH	67.0	67		F	09/26/2009	A few hours after the shot, my throat felt like it had something stuck in it.  I tried everything to clear it, but it took several hours to go away.  It felt like my throat was closing up, however, it wasn't and it did pass.									Y	09/24/2009	09/24/2009	0		UNK	UNK						1						1	Throat irritation	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0358410	09/26/2009	NH	50.0	50		F	09/26/2009	Induration, erythema 3.5 cm around, tenderness, pain entire shoulder region.  Self limited symptoms									Y	09/22/2009	09/23/2009	1	NOne	PVT	PVT	Amoxicillin, ambien, omeprazole, proair, flonase, lisinopril, HCTZ	none	Latex, levaquin, tetracycline, amitriptyline			1						1	Erythema; Induration; Musculoskeletal pain; Tenderness	FLUX~SANOFI PASTEUR~u 3186aa~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0358411	09/26/2009	TX	61.0	61		F	09/26/2009	Sore throat ~ 4 hours after vaccination followed by sore, red and watery eyes and cough. Development of periorbital edema. Lasted ~48 hours.									Y	09/23/2009	09/23/2009	0	None	PUB	UNK	Hormone replacement therapy, Hydrochlorothiazide/triamterene, Ecitalopram, Warfarin	None	Thimerosal (contact allergy)			1						1	Cough; Eye pain; Lacrimation increased; Ocular hyperaemia; Oropharyngeal pain; Periorbital oedema	FLU3~SANOFI PASTEUR~xxxx~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358412	09/26/2009	CA	52.0	52		M	09/26/2009	5 hours after injection: 102 degree tempreture, vomoting, headache. 12 hours after injection tempreture 98.8.  24 to 72 hours after injection on and off chills and overall exhaustion.									Y	09/21/2009	09/21/2009	0		UNK	UNK	none	none	none			1						1	Body temperature increased; Chills; Fatigue; Headache; Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0358414	09/26/2009	MI	51.0	51		M	09/26/2009	WITHIN 24 HRS hoarse, sore throat, congestion, headache, muscle aches, site inflammation, runny nose, fatigue - still present 4 days later									Y	09/23/2009	09/24/2009	1		UNK	PVT	N/A	N/A	N/A			1						1	Dysphonia; Fatigue; Headache; Injection site inflammation; Myalgia; Nasal congestion; Oropharyngeal pain; Rhinorrhoea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~66521011210~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358415	09/26/2009	MI	47.0	47		F	09/26/2009	Within 20 min of vaccine - nauseau, dizziness, earache, muscle ache and weakness, feverish and site pain. Lasted approx. 48 hrs. Bed rest, liquids									Y	09/23/2009	09/23/2009	0		UNK	PVT	levothroid					1						1	Asthenia; Dizziness; Ear pain; Injection site pain; Myalgia; Nausea; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~66521011210~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358455	09/26/2009	TN	43.0	43		F	09/26/2009	Patient developed hematoma at injection site of deltoid of left arm with reddening of upper left arm. Patient was watched for 30 minutes while using ice pack and received diphenhydramine.									Y	09/26/2009	09/26/2009	0	Reviewed VAR with patient and no allergies reported	OTH	PVT	Methotrexate; RELAFEN; PREDNISONE	None	Arthritis			1						1	Injection site erythema; Injection site haematoma	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2A~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358418	09/27/2009	SC	52.0	52		F	09/27/2009	Vivid nightmares on consecutive nights, sore throat begining on day 2.									U	09/25/2009	09/26/2009	1	N/A	UNK	PVT	Meformin, Lisinopril, Lovastatin, OTC vitamin	n/a	Diabetes Type II, hypertension			1						1	Nightmare; Oropharyngeal pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~unknown~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358419	09/27/2009	VA	60.0	60		F	09/27/2009	BEGINNING ONE NIGHT FROM VACCINATION PATIENT BEGAN HAVING FEVER. ALSO RECOVERING FROM SURGERY 2 WEEKS PRIOR.									U	09/25/2009	09/26/2009	1		UNK	PUB			BACK SURGERY 2 WEEKS PRIOR (WITH EXTERNAL TUBES)			1						1	Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960322P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358420	09/27/2009	CA	47.0	47		F	09/27/2009	Injection administered at 10:45 a.m. PDST on September 23, 2009; symptoms began upon awakening the morning of September 24, 2009.  Severe, large solid blocks of redness, tenderness and swelling covering most of upper arm (outside portion of upper arm) on arm that got the injection, severe pain lasting in excess of 4 days preventing patient from normal use of arm, red areas (very large and solid) very hot to the touch; area of arm involved keeps expanding and moving down arm, and as of 4 days after injection, now moving down the arm involving elbow joint and causing joint pain; areas of upper arm less red but still very sore and tender to the touch; Patient will visit doctor on Monday, September 28, 2009 because symptoms have not subsided and more area of arm has become involved (left arm)				Y					N	09/23/2009	09/24/2009	1	None administered yet; patient will see doctor on Monday, September 28, 2009.	UNK	PVT	Patient on 10 mg. flexerel at night; ovcon 35 (birth control)	gastro-intestinal virus not causing fever (onset 9/21/2009) resulting in frequent diarrhea, stomach discomfort	No allergies other than percocet; rheumatoid arthritis (not on any medication; in remission); lupus (not on medication; in remission)	fainting, weakness, convulsions~DTP (no brand name)~1~8.50~In Patient		1						1	Arthralgia; Injected limb mobility decreased; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Systemic lupus erythematosus	FLU3~SANOFI PASTEUR~U3211AA~1~ID~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1296x~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358421	09/27/2009	CA	2.0	2	.6	F	09/27/2009	Kloe received the FluMist 9/26/09. On 9/27, she has a fever 0f 104 F. I gave her Tylenol to treat this fever.									U	09/26/2009	09/27/2009	1		PVT	UNK	None	None	None			1						1	Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0358444	09/27/2009	CA	65.0	65		M	09/27/2009	Had rash, itchy hands-rash on everywhere on body. Received vaccine on 09/22/09 and noticed itching and rash on 09/26/09.									N	09/22/2009	09/26/2009	4		OTH	PVT	DIOVAN HCT 320/25; magic mouthwash		Hypertension			1						1	Pruritus; Rash generalised	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848P1B~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358450	09/27/2009	MN	60.0	60		F	09/27/2009	Patient developed red, circular rash around injection site measuring 3.5 x 5.0 cm. The rash area was warm, red, and painful to patient. These symptoms occurred within 24 hours of vaccines. Patient was seen and treated in Urgent Care 9/27/09 and has a follow up appointment 9/28/09. The area referenced to is the upper left arm.				Y					U	09/25/2009	09/26/2009	1		OTH	PVT						1						1	Injection site erythema; Injection site rash; Pain in extremity; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARZOS~MERCK & CO. INC.~0745Y~2~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0358252	09/28/2009	NE	86.0	86		M	09/24/2009	Pateint was given a pneumococcal vaccine in his right arm about 9:30 AM on 9-16-09 and was given the Influenza vaccine in his left arm at about the same time. He woke up at 2:30 AM on 9-17-09 with his arm being red, swollen, hard, and painful to the touch. He later fainted and was taken to the ER where he was treated and released. Patient has had 4 pneumococcal vaccinations documented in the last 10 years when he would have only been required to get one.				Y					U	09/16/2009	09/17/2009	1		UNK	UNK						1						2	Erythema; Induration; Oedema peripheral; Pain in extremity; Syncope; Erythema; Inappropriate schedule of drug administration; Induration; Oedema peripheral; Pain in extremity; Syncope	FLU3~CSL LIMITED~07549111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~0504Y~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~2|PPV~MERCK & CO. INC.~0504Y~UNK~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0358289	09/28/2009	VA	4.0	4		M	09/28/2009	Pt received vaccines on 09/22/09 and tolerated them well. Mother called 09/23/09 late in the day to report pt has a measles type rash on body (Trunk/Extremities) but no fever-only sl. irritable. Tool pt to pediatrician 09/24/09 who stated it appears to be a measles reaction although that usually takes a week to happen.									Y	09/22/2009	09/23/2009	1	None	PUB	PUB	Multivitamin	None	Down syndrome; Mult. Cardiac Anomalies			1						2	Irritability; Pruritus; Rash morbilliform; Irritability; Rash morbilliform	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B137AA~5~IM~RA~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~U3211AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0449Y~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1009Y~2~SC~LA~VARICELLA (VARIVAX)~1|DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B137AA~5~IM~RA~DTAP + IPV (KINRIX)~2|FLU3~SANOFI PASTEUR~U3211AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2|MMR~MERCK & CO. INC.~0449Y~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~2|VARCEL~MERCK & CO. INC.~1009Y~2~SC~LA~VARICELLA (VARIVAX)~2	USA		Influenza
0358422	09/28/2009	WA	71.0	71		M	09/28/2009	(First day) swelling, redness, and soreness 4 diam around shot; upset stomach, loss of appetite; general fatique; fever and related whole body muscle aches; related chills and sweating - used aspirin 4 times to cover fever and muscle aches. (Second day) Shot area the same, fever and all came on later in the day, used aspirin twice during the night.  (Third day) Shot area the same - pain interferes with sleep, complete exhaustion, loss of appetite, fever doesn't seem so bad, so there's hope for recovery.  But I seem to fall into the 1% that develop fever, muscle aches, and severe local reactions.									N	09/25/2009	09/25/2009	0	none	PUB	PUB	normal asthma and blood pressure pills, long term, nothing unusual	none	none	none~ ()~NULL~~In Patient		1						1	Abdominal discomfort; Chills; Decreased appetite; Fatigue; Hyperhidrosis; Injection site erythema; Injection site pain; Injection site swelling; Myalgia; Pyrexia; Sleep disorder	FLUX~UNKNOWN MANUFACTURER~~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~IM~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0358438	09/28/2009	NY	51.0	51		M	09/25/2009	Was very whiny very unlike him. Did not want to eat said that did not feel good - Next morning was pale, light headed, dizzy. On 3 instances people offered to help him do his work which is very out of the norm. He tried to eat bananas and food to feel better. Finally got home on 9/23 by 6 PM and said that while on the truck with AC felt OK but felt like falling down with no AC. He has been taking his blood pressure medication. Today feels fine.									Y	09/22/2009	09/22/2009	0		PVT	PVT	Hydrocodone; EXCEDRIN for migraine headaches		Blood pressure; Seasonal allergies	Flu-like symptoms.~Influenza (Seasonal) (no brand name)~UN~58.00~Patient		1						1	Diet refusal; Dizziness; Feeling abnormal; Irritability; Pallor	FLUX~UNKNOWN MANUFACTURER~~1~IJ~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0358468	09/28/2009	IN	36.0	36		F	09/24/2009	Really fast heart rate, shortness of breath, chest tightness. Took INDERAL by 10pm felt better. Right now feels achy.				Y					Y	09/21/2009	09/22/2009	1		OTH	OTH	No	No	No	None~ ()~~0.00~Patient		1						1	Chest discomfort; Dyspnoea; Heart rate increased; Pain	FLUX~UNKNOWN MANUFACTURER~AFLUA450A~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0358483	09/28/2009	UT	1.2	1	.2	M	09/18/2009	Mother brought twins a male and a female on Monday, Sept. 14th to get 1 yr. immunizations. Mother had her cards we given her when we gave then prior vaccines. The CDP that was printed didn't match her card. I looked up past encounters to find out when the history was given to us. The information was not provided by the parent when she had come in for immunizations so i was not sure if it was entered by mistake. I tried look up both child and was unable to access them at the time. I did read the note in CDP by agency that history given by the MD office was entered in CDP on 022609 and they needed one year immunizations. (SMC did give an extra set of immunizations on Mar. 13th when only a Hep B was the only vaccine needed). The immunizations I gave with the current information I had lead me to believe the one year immunizations were due then. Later I was able to pull up information on one twin only and found that another clinic had given her 2,4,6 mos. & 1yr immunizations which is what we had done due to not having the history. Before giving any immunizations on 091409 I asked the mother if any other vaccines had been give to them besides the ones on the card the mother said No. When i asked about the dates recorded from September she said, They were done that one time (when she went to clinic).									Y	09/14/2009			2.4.6 mostly multiple vaccines given - twice	PUB	PUB		None	None			1						1	Incorrect dose administered	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~UNK~UN~UN~HIB (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~UNK~UN~UN~VARICELLA (NO BRAND NAME)~1	USA		Influenza
0358484	09/28/2009	UT	1.2	1	.2	M	09/18/2009	Mother brought twins a male & a female on Monday, Sept. 14th to get 1 yr. immunizations. Mother had her cards we had given when we gave them prior vaccines. The CDP that was printed didn't match her card. I looked past encounters to find out when the history was given to us. the information was not provided by the parent when she had come in for immunizations so I was not sure if it was entered by mistake. I tried look up both children was unable to access them at the time. I did read the note in CDP by agency that history given by MD office was entered in CDP on 022609 and they needed one year immunizations.   (SMC did give an extra set of immunizations on Mar. 13th when only a Hep B was the only vaccine needed). The immunizations I gave with current information I had led me to believe the one year immunizations were due then. Later I was able to pull up information on the female twin only and found that another clinic had given her 2, 4, 6 mos. & 1 yr immunizations which is what we had done due to not having history. Before giving any immunizations on 091409 I asked the mother if any other vaccines had been give to them besides the ones on the card the mother said No. When I asked about the dates recorded from September she said, They were done that one time (when he went to Clinic). No medical treatment required.  Follow-up - I tried to call the mother the next day to find out how the twins were doing. Mom was not available to spoke to me the aunt was the only one who spoke English and she said they were doing fine. Corrective action - I left message with Dr. at Clinic to let her know what had happened to her patients. The twins still need the second dose of Hep A six months after Sept. 14th, 2009. Their records states Hep A was given July 28th 2009 which will be too early if mother comes in for second dose the end of January. Call 3 days later no problems reported.									Y	09/14/2009				PVT	PUB		None	None			1						1	Incorrect dose administered	DTAP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTAP (NO BRAND NAME)~1|FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1|HIBV~UNKNOWN MANUFACTURER~~UNK~UN~UN~HIB (NO BRAND NAME)~1|IPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~UN~UN~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~UNK~UN~UN~VARICELLA (NO BRAND NAME)~1	USA		Influenza
0358485	09/28/2009	WA	8.0	8		M	09/25/2009	None stated. 11/25/09:  Hospital records received for dates of service 9/24/09 to 9/25/09.  Dx:  Anaphylactic reaction to immunization and asthma.  Developed wheezing, coughing and urticarial rash with swelling of eyelids and lips one half hour after immunizations.  Red area around injection site. Admitted to CCU.   Steroid therapy, albuterol and benadryl  and IV therapy initiated.  Discharge in improved condition.				Y	Y	1			Y	09/24/2009	09/24/2009	0	None.  11/25/09:  Hospital records received for dates of service 9/24/09 to 9/25/09.  Labs and Diagnostics:  CXR WNL.	PVT	PUB		Cough X 6 days	Remote H/O RAD; Current URI's.  11/25/09:  Hospital records received for dates of service 9/24/09 to 9/25/09.  PMH: Diaphramatic hernia with repair, reactive airway disease.   NKDA.			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U3201AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB312AA~1~IM~RA~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~0584Y~2~SC~LA~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0358488	09/28/2009	WA	5.0	5		M	09/23/2009	Guillain-Barre Syndrome. Sx: Pain on lower extremities, very tender to touch and weakness and difficulty walking. Pt was given an IVIG treatment. 12/3/09 DC summary received for date 1/7/09 to 1/11/09. DX: abnormality of gait, pain in limb, polyneuritis. SX: acute onset of limb pain, weakness, gait disturbance.Assessment: very early in course of acute onset of GBS/AIDP.  Hospital course received IVIG. Pt improved at dc. 12/7/09 Medical records received for dates 1/7/09 to 1/14/09. DX: GBS. Chief c/o leg pain. Pt parent states pt woke up w/ severe bilat leg pain and would not walk. Pt parent states unusual gait and weakness. Pt had febrile illness x2wks ago. Assessment: mild trunk weakness, proximal weakness. 1/14/09 DX: GBS f/u. Pt was admitted for GBS received IVIG. Pt was readmitted on 1/12/09 for HA, vomiting, abdominal pain. Pt stable on this day. Parent feels GBS related to seasonal flu vax on 11/8/08.			Y	Y	Y	5			U	11/08/2008	01/06/2009	59	(Blood test); CBC; ESR; CK; MRI (Brain/Spine); Lumbar puncture; EMG 12/3/09 DC summary received for date 1/7/09 to 1/11/09 Diag/labs: MRI(-), LP(-), EMG(-).  12/7/09 Medical records received for dates 1/7/09 to 1/14/09. Diag/Labs: LP(-), MRI(-), CBC WNL, BUN 24(H), sed rate 52(H)	PVT	PUB	None	None	None 12/7/09 Medical records received for dates 1/7/09 to 1/14/09.PMH: dense penile adhesions w/ repair, constipation, otitis media.			1						1	Blood creatine phosphokinase; Blood product transfusion; Gait disturbance; Guillain-Barre syndrome; Hyperaesthesia; Muscular weakness; Pain in extremity; Red blood cell sedimentation rate; Tenderness	FLU3~SANOFI PASTEUR~U280899~7+~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0358493	09/28/2009	NY	31.0	31		F	09/23/2009	Weakness, fever (101 degree F), nausea 09/18/09.  Sore throat on 09/17/09 dizziness, headache.									Y	09/16/2009	09/17/2009	1		PUB	OTH		None	None			1						1	Asthenia; Dizziness; Headache; Nausea; Oropharyngeal pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA474BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0358494	09/28/2009	FL	78.0	78		M	09/22/2009	Seizure in arms and legs uncontrollable.				Y					Y	09/01/2009	09/01/2009	0	Focal Motor Seizures	PUB	PUB	LIBRIUM; Hysocyamine; Skaecaxin; Omega 3; PRILOSEC; Multivitamin	Kidney stones	None			1						1	Convulsion; Dyskinesia; Partial seizures	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA261AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0358495	09/28/2009	MS	66.0	66		F	09/24/2009	Arm was swollen and red. Painful to the touch. The day after injection, she went to doctor and was treated with antibiotics ad steroids.				Y					Y	09/08/2009	09/08/2009	0		OTH	OTH						1						1	Erythema; Hyperaesthesia; Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840pL~UNK~SC~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0632Y~UNK~SC~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358497	09/28/2009	TX	52.0	52		M	09/21/2009	Friday (9-17-09 evening facial area above upper lip extending to above eyes and from left of eyes to right side of face redness with some itching. Redness in bend of left arm. No redness or itching at injection site. Started BENADRYL 50mg q 4 hrs. Sat. am Sun had BENADRYL injection symptoms improving.									Y	09/17/2009	09/18/2009	1		MIL	UNK						1						1	Erythema; Pruritus	FLU3~SANOFI PASTEUR~U3202AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0866X~1~IM~LA~HEP B (RECOMBIVAX HB)~1	USA		Influenza
0358498	09/28/2009	FL	40.0	40		F	09/28/2009	Sensation of a swollen throat, itchiness in the throat and a hoarse voice. Slight dyspnea. To ER: IV-SOLU-MEDROL 125 mg; ZYRTEC 10 mg PO; Rx given for: Prednisone and ZYRTEC. In ER 1 hr for observation following tx.				Y					Y	09/25/2009	09/25/2009	0	No hx of previous reaction to Flu vaccination	PVT	PVT	Blood pressure meds.	None	NKA			1						1	Dysphonia; Dyspnoea; No reaction on previous exposure to drug; Pharyngeal oedema; Throat irritation	FLU3~SANOFI PASTEUR~U3253CA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358499	09/28/2009	IN	11.0	11		M	09/28/2009	Patient became dizzy- light headed and blurred visoin. Patient experienced syncopal episode and blood pressure dropped to 90/48. Patient was laid down and feet elevated. Juice given and patient recovered feeling after ~ 15 minutes.									Y	09/28/2009	09/28/2009	0	None	PVT	PUB	None	None	None			1						1	Blood pressure decreased; Dizziness; Syncope; Vision blurred	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960327AA~1~IM~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB327AA~1~IM~RL~HEP A (HAVRIX)~1|MNQ~SANOFI PASTEUR~U3012AA~1~IM~RL~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52BO37AA~1~IM~LL~TDAP (BOOSTRIX)~1	USA		Influenza
0358501	09/28/2009	TX	54.0	54		F	09/28/2009	Redness and swelling of left arm below injection site. Patient states reaction has lessened in severity over last two days.									Y	09/24/2009	09/25/2009	1	NONE	OTH	PVT	LOTRIL; Mobic	NONE	Osteoarthritis; hypertension, CVD			1						1	Injection site erythema; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA458AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0358502	09/28/2009	NE	31.0	31		F		- Pain going down left arm - Swelling in hand - Gave oral BENADRYL - Instructed to acp cold compress per verbal conversation w/Dr. at ER									U	09/26/2009	09/26/2009	0		OTH	PVT		None				1						1	Oedema peripheral; Pain in extremity	FLU3~SANOFI PASTEUR~U3187AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358503	09/28/2009	AL	4.0	4		F	09/28/2009	Erythema multiforme and urticaria 8 days post vaccination. Treated with BENADRYL and oral steroids.				Y					Y	09/14/2009	09/22/2009	8	None	PVT	PVT	None	None	None	varicella~Varicella (Varivax)~1~1.00~Patient		1						1	Erythema multiforme; Urticaria	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B100BA~5~IM~LL~DTAP (INFANRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~5006B1P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~SANOFI PASTEUR~D0042~4~IM~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0710Y~2~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0997Y~2~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0358506	09/28/2009	WI	21.0	21		F	09/24/2009	9/11/09-Red and sore at PNEUMOCOCCAL administration site - Also, fever 100.5F and sore throat - Primary care visit diagnosed with influenza like illness. 9/11/09 - Emergency room visit - treated for Cellulitis. 9/14/09- Primary care visit for cellulitis- at flu and PNEUMOCOCCAL sites.				Y					Y	09/10/2009	09/11/2009	1		OTH	UNK		Crohn's Disease - stopped corticosteroid previous week.	Crohn's Disease, asthma - exercise, induced, depression.			1						1	Cellulitis; Influenza like illness; Injection site erythema; Injection site pain; Oropharyngeal pain; Pyrexia	FLU3~CSL LIMITED~07949111A~2~IM~LL~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~0466Y~UNK~SC~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358508	09/28/2009	FL	26.0	26		F	09/16/2009	Swelling, redness, warm to the touch, around area were shot administered.  Irritation for one day.  Symptoms lasted 3 days:  Warm cloth put over area to help with swelling.									Y	09/09/2009	09/10/2009	1		PUB	PUB						1						1	Injection site erythema; Injection site irritation; Injection site swelling; Injection site warmth	FLU3~CSL LIMITED~06549111A~1~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358509	09/28/2009	FL	50.0	50		F	09/16/2009	Redness and swelling at injection site. Tender to touch, and slightly warm.									Y	09/09/2009	09/09/2009	0	None	PUB	PUB	None	None	None			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~CSL LIMITED~06549111A~1~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358510	09/28/2009	FL	52.0	52		F	09/16/2009	Generalized muscle aches, low grade temp (99.5 - 100 degrees) headache for 12 hr after injection.  Localized redness, swelling ( 3 long X 1 wide area) at injection site, started day of injection, lasted 4-5 days.									Y	09/09/2009	09/09/2009	0		UNK	UNK	SYNTHROID; ALBUTEROL inhaler; NEXIUM; hypothyroidism	None	Allergic - PCN; Sulfa; FLOXIN; asthma; fibromyalgia; arthritis; MVP.			1						1	Body temperature increased; Headache; Injection site erythema; Injection site swelling; Myalgia	FLU3~CSL LIMITED~06549111A~1~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358511	09/28/2009	FL	45.0	45		F	09/16/2009	Redness, swelling, tender, lump hot to touch.  Cramping in stomach.									Y	09/09/2009	09/09/2009	0		PUB	PUB		None				1						1	Abdominal pain; Erythema; Mass; Skin warm; Swelling; Tenderness	FLU3~CSL LIMITED~06549111A~1~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358512	09/28/2009	FL	42.0	42		F	09/24/2009	Significant redness and swelling to injection site.  Tender to touch lasted 3-4 days.  Took MOTRIN for discomfort.									Y	09/09/2009	09/09/2009	0		PUB	PUB	None		Allergy: PCN			1						1	Injection site erythema; Injection site swelling; Tenderness	FLU3~CSL LIMITED~06549111A~1~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358527	09/28/2009	NC	76.0	76		M	09/28/2009	A few hours after receiving vaccine began to feel weak and mild fatique, then a cough started.the next day felt worse with a low grade fever; on second day was completely washed out with a fever - stayed in bed all day. On the third day, felt better and the fever subsided, took my pulse and it was 100 - normally 70. It's the rapid pulse that concerns me. TWill call the Doctor as soon as his office opens.									U	09/25/2009	09/25/2009	0		UNK	UNK						1						1	Asthenia; Cough; Fatigue; Heart rate increased; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358529	09/28/2009	FL	30.0	30		F	09/28/2009	numbness and tingling in fingers and feet, dizziness, blurred vision that progressed to shortness of breath, rash, tongue swelling and inability to feel legs				Y					Y	09/25/2009	09/25/2009	0		UNK	UNK	2 a day diet pills	none	none			1						1	Dizziness; Dyspnoea; Hypoaesthesia; Paraesthesia; Sensory loss; Swollen tongue; Vision blurred	FLU3~CSL LIMITED~0854911A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0358531	09/28/2009	IN	10.0	10		M	09/28/2009	Patient suffered fist size welts which were red and hot on his arms and legs.  He had pain in the arms and legs.  Hives occurred under his arms, on his back, legs, and arms.  Severe itching occurred with this for 5 days.  He was treated with Prednisone and Ranitidine.  He has NO history of egg allergies.				Y					Y	09/11/2009	09/11/2009	0		UNK	UNK	Claritin, Nasonex	Patient was diagnosed with a sinus infection 10 days prior to receiving the flumist. Had finished Augmentin 3 days prior to receiving flumist.	Patient has seasonal allergies and takes claritin and nasonex daily.			1						1	Erythema; Pain in extremity; Pruritus; Skin warm; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0358532	09/28/2009	NC	61.0	61		M	09/28/2009	11/15/07 - high fever, severe headache, shaking chills, diarrhea, weakness, blurred vision, trouble breathing, trouble walking, 11/17/07 ambulance to ER, collapsed when tried to stand, hospitalization, could not walk within 2-3 days, said had pneumonia and viral infection, have physical therapy since then to go from wheel chair, to walker and now trying to go to cane. Still cannot stand but short time or walk but short distances with aid, can't bend, constant pain shoulders to feet, have trouble bathing and dressing, some numbness that comes and goes, need help with preparing food, have tremors, been to numerous doctors diagnosed with Guillian Barre Syndrome by Dr. at Medical Center and Dr. of Neurology.  Sensory AIDP GBS.Records received 10/8/09, Date of Service: 9/10/09  Date of Assessment 9/10/09, Follow up Neuro consult:  Findings most compatible with a predominantly sensory variant of Guillian-Barre Syndrome (GBS) with residual persistent neuropathic pain likely secondary to that process with some contribution from an underlying diabetic polyneuropathy.    On 11/15/07 patient experienced high fever, severe headache, shaking chills, diarrhea, weakness, blurred vision, trouble breathing and trouble walking.  On 11/17/07 seen in the ER where he collapsed upon trying to stand.  Hospitalized and could not walk within 2-3 days.  Was said to have pneumonia and a viral infection.  He is still unable to stand for long, or walk long distances.  He cannot bend.  C/O constant pain from shoulders to feet.Has trouble with ADL's.  He has numbness that comes and goes as well as tremors.  He was hospitalized for 5 days.  Has been diagnosed by numerous doctors with GBS or Sensory AIDP GBS.  He was treated with IVIG twice a week for one month.  Current review of systems is significant for poor energy, fatigue, change in appetite, joint pain, joint swelling, weakness, back and neck pain, insomnia, poor balance, numbness and tingling and tremors.    10/12/09 Medical records received for Neurology consults from date range 3/3/08 to 6/2/09. DX 3/3/08 Leg weakness, some parethesias, lower extremity weakness greater than upper extremity weakness, preserved reflexes. Impression:Could have GBS verses CIDP.  Primary symptoms: weakness in legs. 3/18/09 Neurological consult f/u: DX: weakness and gait disturbance. Impression: Not consistent with CIDP or GBS. SX: weakness in lower extremities.  6/26/08 and 12/3/08 No change in DX/Impression from previous visit.  SX: F/U visits for leg weakness pain increasing up to shoulders. Pt now using wheelchair. Pt stated has had extensive workup including IVIG treatment. 3/3/09 DX/Impression: not clear what problem is, it still has a flavor of CIDP.  SX: weakness and pain still, rib pain, right leg stronger than left. Walking with cane and walker.  6/2/09 F/U Impression: pt doing somewhat better. SX: some increase in strength noted in lower extremities.				Y	Y	5		Y	N	10/26/2007	11/15/2007	20	Nerve condition studies, EMGs, CT scans, MRIs, xrays, lumbar punctures, IVIGs, blood work, PET scan, 24 hour urine tests for heavy metal, ultrasounds, colonoscopy.  NCS and EMG show nerve damage.  Blood work shows autoimmune problems. Lumbar puncture show high protein levels. Other tests were negative or normal. Records received 10/8/09:  Diagnostics and Labs:  NCS:  Abnormal (9/10/09). Conclusion:  This mildly abnormal study demonstrates limited evidence for peripheral neuropathy.  The findings could reflect mild, sensory AIDP with recovery.  PET Scan: Negative (8/20/08).  Colonoscopy:  Negative.  Paraneoplastic panel: positive for anti-voltage gated potassium channel antibodies.  MRI of brain: Normal (11/04/08). Electrodiagnostic studies: Abnormal (7/11/08).  EMG:  Abnormal (7/11/08)   Skeletal survey:  Normal (7/25/08).  CT of the Chest:  Abnormal (7/23/08).   CSF: bloody with 3,275 RBC's.  ANA:  Negative.  ANCA:  Negative.  Anti-DNA: Negative. 10/12/09 Medical records received for Neurology consults from date range 3/3/08 to 6/2/09. Diagnostics/Labs: CXR(-), CT abdomen and pelvis(-), CT head(-), MRI head(-),  CSF culture(-), CSF protein 52(H), Glucose 160(H), HCT 37.5(L), CK 46 WNL.	UNK	UNK	Advair, Lipitor, Glucovance, Diovan, Aciphex, Singular, Albuterol, ibuprophen, multi vitamin, elocon, evoxac, tylenol,	Had checkup that day, doctor said I was fine, had stress test and it was fine too.	asthma - very seldom had to use inhaler, fibromyalgia - went thru pain management so was not on medication for that, diabetes type 2 - under control with oral medication, seasonal allergies, Records received 9/10/09:  Past Medical History:  Asthma, fibromyalgia, type 2 diabetes, seasonal allergies, oral surgery, vasectomy, knee surgery x 2, tonsillectomy, CIDP and obesity.  Allergies to betadine and Celebrex.			1						1	Activities of daily living impaired; Asthenia; Blood test abnormal; Chills; Colonoscopy normal; Computerised tomogram normal; Diarrhoea; Dyspnoea; Dysstasia; Electromyogram abnormal; Gait disturbance; Guillain-Barre syndrome; Headache; Hypoaesthesia; Immunoglobulins normal; Lumbar puncture abnormal; Nerve conduction studies abnormal; Pain; Pneumonia; Positron emission tomogram normal; Pyrexia; Syncope; Tremor; Ultrasound scan normal; Urine analysis normal; Viral infection; Vision blurred; Walking aid user; Wheelchair user; X-ray normal	FLU3~GLAXOSMITHKLINE BIOLOGICALS~unknown~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation,Disabling	Influenza
0358533	09/28/2009	GA	70.0	70		F	09/28/2009	Rash developed under arms and on trunk on 9-26-09 after received Influenza vaccine on 9-25-09. Rash seems to be drying up.									Y	09/25/2009	09/26/2009	1		PUB	PVT		Chronic illness, no acute respiratory illness				1						1	Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98434P1~3~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358536	09/28/2009	NY	68.0	68		F	09/22/2009	Patient woke up on 9/19/2009 with upper arm very sensitive.  As the day progressed, upper arm got warm, red and swollen (in the area where the shot was adminsitered).  Patient seen by provate MD on 9/20/2009 put on prednisone 4mg x 6 doses in decreasing doses (Sun - 24mg, Mon - 20mg, Tues - 16mg, Wed - 12mg, Fri. - 8mg, Sat- 4mg. Then D/C).				Y					Y	09/18/2009	09/19/2009	1		PUB	PVT	Altace, Atenolol, Prevacid, Synthroid, Coumadin, Provastatin	None	Diabetes, HTN, atrial fib, GERD hypotharoidism, psoriatic arthritis.			1						1	Hyperaesthesia; Injection site erythema; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA460AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~1076X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358538	09/28/2009	ME	5.0	5		F	09/28/2009	Within 48 hours of receiving nasal mist:  headaches, fever 100-101, stomach pain, sore throat, aches.  Our daughter is one of SIX children ages 10-14 on our BLOCK who had the same symptoms within 24 hours of getting vaccinated.									U	09/25/2009	09/27/2009	2		UNK	UNK		none at time of vaccination....within 48 hours	none			1						1	Abdominal pain upper; Headache; Oropharyngeal pain; Pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0358539	09/28/2009	IL	24.0	24		F	09/28/2009	Patient c/o mild dizziness, nausea 10 minutes after FluMist administration.  Patient had one episode of vomiting 40 minutes post FluMist Vaccination.  Patient indicated she had some initial transient itching on chest and arms which resolved within minutes.  Denied SOB, blackout, tight throat, chest pain, itching, rash, or any other symptoms.  Symptoms of dizziness and nausea resolved within the hour with bed rest.  Provider stated symptoms consistent with vasovagal phenomenon following vaccination with FluMist.				Y					Y	09/24/2009	09/24/2009	0	None performed	MIL	MIL	None	No	No			1						1	Dizziness; Nausea; Presyncope; Pruritus; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500691P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0358540	09/28/2009	KY	39.0	39		F	09/28/2009	Pt reported thigtness in throat approx. 1 hour after vaccine given.  Then lip swelling and eye lid swelling within the next 30 minutes.  Also throat scratchy and headache. She talked to a friend that is a nurse and was told to take benadryl.  The pt took the benadryl and noted an improvment in symptoms.  Didn't see a MD.  I saw the pt on 9-25-09 and symptoms were not noted.									Y	09/23/2009	09/23/2009	0		PUB	PVT				scratchy throat~Influenza (Seasonal) (no brand name)~UN~~In Patient		1						1	Eyelid oedema; Headache; Lip swelling; Throat irritation; Throat tightness	FLU3~SANOFI PASTEUR~u3202aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358542	09/28/2009	IL	19.0	19		M	09/28/2009	Patient c/o mild dizziness with nausea and one episode of vomiting following FluMist vaccination.  Dizziness and nausea occurred about 15 minutes post vaccination.  Vomiting episode was approximately 50 minutes post vaccination.  Patient denied SOB, blackout, tight throat, chest pain, itching, rash, or any other symptoms.  Symptoms of dizziness and nausea resolved within the hour with bed rest, but a mild 2/10 dull, throbbing headache remained which is consistent with his typical headaches patient experiences.  Physician states symptoms consistent with vasovagal phenomenon following vaccination with FluMist.				Y					Y	09/23/2009	09/23/2009	0	None	MIL	MIL	None	None	None			1						1	Dizziness; Headache; Nausea; Presyncope; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500691P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0358545	09/28/2009	CA	0.63	0	.8	F	09/28/2009	Patient was seen on 25 Sept 2009 due to hives 3 days afer receiving Fluzone Free 6-35 months.									Y	09/22/2009	09/25/2009	3	None	MIL	MIL	None	None	None			1						1	Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~U2791DA~1~IM~RL~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0358546	09/28/2009	AZ	27.0	27		F	09/28/2009	Pt developed a half dollar sized red, swollen area at injection site									Y	09/23/2009	09/25/2009	2		PUB	UNK						1						1	Injection site erythema; Injection site swelling	FLU3~CSL LIMITED~05649111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358547	09/28/2009	AL	70.0	70		M	09/28/2009	The day after recieving the vacine the patient experience nausea, vomiting and a temp of 103 degrees F. Spoke with PCP and was confident it was from the vaccine									Y	09/24/2009	09/25/2009	1		UNK	UNK	metformin, synthroid, zocor, plavix and lisinopril	None				1						1	Body temperature increased; Nausea; Vomiting	FLU3~SANOFI PASTEUR~u3202aa~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358548	09/28/2009	PA	29.0	29		F	09/28/2009	I received my flu shot at approximately 9:00am on 9/26/09. I had no illness at the time of the vaccination. About 10 seconds after the vaccination I developed mild nausea and a mild non-migraine headache. About 2 hours later I developed a sore throat. That same day the nausea and headache subsided. Later that same day and all day on 9/27 I had severe malaise. On 9/28/09 I developed a migraine. I took acetaminophen (TYLENOL) for treatment on 9/26 and 9/27, and I took 2 ibuprofen (ADVIL) tablets on 9/28. I still have a migraine.									N	09/26/2009	09/26/2009	0	none	PUB	PVT	Glumetza ER, 500 mg TID; Synthroid, 88 mcg Daily; multivitamin	none	PCOS, hypothyroidism, seasonal allergies	mild nausea~Influenza (Seasonal) (Fluarix)~NULL~21.60~In Patient		1						1	Headache; Malaise; Migraine; Nausea; Oropharyngeal pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0358549	09/28/2009	MI	15.0	15		F	09/28/2009	After administering vaccination the guest was standing at the counter, feeling light-headed and proceeded to faint, recover a few seconds later and proceed to faint again.									Y	09/28/2009	09/28/2009	0		UNK	PVT		none	none			1						1	Dizziness; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358550	09/28/2009	WV				U	09/28/2009	DEVELOPED FEVER, ACHES, HEADACHE, COUGH, HOARSENESS, CHILLS, FATIQUE, 0 ENERGY. TIMEFRAME WITHIN 12 HOURS. CALLED MY DR AND THEY TOLD ME TO TAKE TYLENOL AND ETC AND IF I FELT WORSE GO TO THE EMERGENCY ROOM. NEVER GOT ANY BETTER CALLED MY DR AGAIN-NO HELP. i WOUND UP GOING TO CLINIC AND GOT EXAMINED AND THEY PUT ME ON ANTIBIOTIC LEVAQUIN --TOOK SEVERAL TESTS NEGATIVE FOR FLU--CHEST XRAY NEGATIVE FOR PNEUMONIA. I WAS FINE UNTIL I TOOK THE FLU SHOT.									Y	09/15/2009	09/16/2009	1	09-23-09--FLU TEST--09-23-09 CHEST XRAY FOR PNEUMONIA--	UNK	UNK		NONE	TAKE ALLEGRA D FOR ALLERGIES ON AND OFF			1						1	Asthenia; Chest X-ray; Chills; Cough; Dysphonia; Fatigue; Headache; Laboratory test; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0358551	09/28/2009	NC	58.0	58		F	09/28/2009	Patient received the vaccine on 9/24/2009.  She returned 24 hours later with redness surrounding the injection site. The area was warm to the touch. Patient reported severe itching at the site starting 6-8hours after the injection.  Following our advise, she followed up at an urgent care clinic.  The clinic prescribed an antibiotic and endorsed our recommendation to try diphenhydramine.  Upon follow-up on 9/28, she had not take the antibiotic or diphenhydramine due Krohn's disease.				Y					Y	09/24/2009	09/24/2009	0		UNK	PVT			Crohn's Disease			1						1	Injection site erythema; Injection site pruritus; Injection site warmth	FLU3~SANOFI PASTEUR~U3209AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358553	09/28/2009	GA	39.0	39		F	09/28/2009	4 hours after vaccine administration, opposite arm became red and swollen. Later, injection side became swollen and red. Seen in ER, prescribed Benadryl and Solumedrol.				Y					Y	09/23/2009	09/23/2009	0	None	PUB	PVT	Synthroid	None	None			1						1	Erythema; Injection site erythema; Injection site swelling; Oedema peripheral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA468CA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0358554	09/28/2009	CA	3.0	3		M	09/28/2009	Fever and urticaria developed 2 days after administration of FluMist.				Y					Y	09/22/2009	09/24/2009	2		PVT	UNK						1						1	Pyrexia; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500677P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0358555	09/28/2009	MI	24.0	24		F	09/28/2009	first flu immunization lt deltoid 9/19/2009.  C/O of burning sensation through out that day with some redness and itching at site.  Two days later C/O feeling exhausted, muscle aches, chills, nasal congestion.  Sleeping 8 hours per night, but still feeling tired the next day.  SOB with exertion.  No medications									U	09/18/2009	09/28/2009	10	none done	PVT	UNK	implanon	non	migrane head aches, thyroid problems, eczema,			1						1	Burning sensation; Chills; Dyspnoea; Fatigue; Injection site erythema; Injection site pruritus; Myalgia; Nasal congestion	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA456AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0358556	09/28/2009	FL	47.0	47		M	09/28/2009	Swelling Pt received flu shot on 9/16 in left deltoid after immunization pt experienced itching at site. On 9/17 pt experienced body aches and lethargy. On 9/18 pt noticed swelling in lymph nodes under right arm and pain in elbow and hand.				Y					Y	09/16/2009	09/17/2009	1	N/A	MIL	MIL		no	Per pt, has had prior rxns to flu vaccine in the past, but does not specify	unknown~Influenza (Seasonal) (no brand name)~~0.00~Patient		1						1	Arthralgia; Injection site pruritus; Injection site swelling; Lethargy; Lymphadenopathy; Pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0358557	09/28/2009	MN	45.0	42		F	09/28/2009	Fever of 101; significant body aches and pains									Y	09/14/2006	09/15/2009	1097		UNK	UNK		no	similar side-effects with 2000 influenza vaccine			1						1	Pain; Pyrexia	FLU3~CSL LIMITED~08749111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358558	09/28/2009	FL	83.0	83		F	09/28/2009	The evening after shot she developed pain from her left shoulder to elbow. Pain was not relieved with tylenol. Still has some discomfort on the day of this report. This report received RN									Y	09/25/2009	09/25/2009	0		UNK	UNK	Glypizide, lasix	none	diabetic			1						1	Discomfort; Injection site pain	FLU3~SANOFI PASTEUR~UT3172AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358559	09/28/2009	MD	48.0	48		F	09/28/2009	Received shot on 9/24/09.  Began with a migraine that afternoon that lasted 3 days.  Pain and swelling at injection site.  By 9/26 had swelling in base of neck -- which doctor advised was swelling in my lymph node. As of today 9/28/09, swelling still in base of neck.     Doctor advised that shot was Flu Zone and that I had a reaction to the preservative in the shot.									Y	09/24/2009	09/24/2009	0		UNK	UNK	Verapamil 360	no				1						1	Injection site pain; Injection site swelling; Lymphadenopathy; Migraine; Reaction to preservatives	FLU3~SANOFI PASTEUR~~UNK~IJ~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358562	09/28/2009	AZ	52.0	52		M	09/28/2009	Developed Cellulitis and was hospitalized in extreme pain. 10/2/09 Medical records received for date of service 9/26/09 to 9/27/09. DC DX: Syncope secondary to vasovagal cause. Rt upper arm cellulitis.  Presenting Symptoms: Pt c/o 1 day post vaccination severe pain right upper arm, fell and passed out. 3 episodes of syncope while at home.  At time of incident c/o nausea, dizziness. Cellulitis on right upper arm at the injection site.				Y	Y	1			U	09/24/2009	09/25/2009	1	10/2/09 Medical records received for date of service 9/26/09 to 9/27/09. Diagnostics/Labs: EKG NSR, CT angiogram, CT abdomen/pelvis, US upper extremitiy, CXR all normal. (+)orthostatics, WBC 12.9(H), neutrophils 81%(H), BUN 23(H)	UNK	UNK		none	none 10/2/09 Medical records received for date of service 9/26/09 to 9/27/09.PMH: carotid body tumor, trigeminal neuralgia, cholecystectomy, anxiety disorder.			1						1	Cellulitis; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~972165P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~2396X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0358563	09/28/2009	MA	17.0	17		F	09/28/2009	pt given adult vaccine pt is 17 y.o.									Y	09/21/2009				PVT	PVT		n/a	n/a			1						1	Inappropriate schedule of drug administration	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA474CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0358565	09/28/2009	IL				F	09/28/2009	Within 3 hrs of administration, achiness, extreme fatigue, slight nausea, head and extremties felt heavy.									U	09/28/2009	09/28/2009	0		UNK	UNK	allergy med injections weekly	None	Ragweed allergy,			1						1	Fatigue; Head discomfort; Nausea; Pain; Sensation of heaviness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA468BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0358567	09/28/2009	ND	19.0	19		F	09/25/2009	Pt. given flumist.  Pt. stated felt fiine.  Amb. to reception area of clinic - told receptionist she wasn't feeling well - receptionist went to to get writer.  Writer immediately went to pt. finding her face down on floor.  Pt. turned onto back, alert but dazed, vitals stable - Pt. quickly alert and oriented.  Moved by w/c to bed.  Eating/drinking.  12:29pm Pt. left clinic amb. per self.  (Pt. had an approx. 3 cm. abrasing to (R) temple - seen by provider.)									Y	09/25/2009	09/25/2009	0		UNK	PUB	unknown	none	allery to benzyl peroxide			1						1	Depressed level of consciousness; Excoriation; Fall; Malaise	FLUN3~MEDIMMUNE VACCINES, INC.~500685P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0358568	09/28/2009	MA	4.0	4		M	09/28/2009	Patient immediately c/o intense pain at injection site and parents noted bruising and swelling immediately.  Pain continued over the next week. 10 days after injuction noted rash begining at injection site and extending down arm to radial aspect of R hand including R 1st and 2nd digits.  Rash is vesiculpapular.  Pain improved but persists 12 days later.				Y					N	09/16/2009	09/16/2009	0	None	UNK	PVT	None	URI symptoms, afebrile	None	None~ ()~NULL~~In Patient|None~ ()~NULL~~In Sibling1		1						1	Immediate post-injection reaction; Injection site haematoma; Injection site pain; Injection site rash; Injection site swelling; Rash pustular	FLU3~SANOFI PASTEUR~U329AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358569	09/28/2009	UT	67.0	67		F	09/28/2009	some dizziness within a few minutes.  19 hours later,severe nausea promptly turning to cramps in the stomach and intestine area so severe I laid on the floor only able to focus on the Intense pain.  It went on for about 40 minutes, heavy breathing, itching palms of my hands.  I describe it as a siege or attack on my body.  I have given birth to 10 children and I can only say the pain of this reaction was so terrible my husband said if it doesn't go away soon I'm taking you to emergency.  I was left exhausted and with a continual stomach ache for hours.  I was unable to eat anything until about 2p.m.   Costco's pharmacy scheduled six different dates for people to come and administer flu shots.  I don't know the name of the group.									Y	09/25/2009	09/26/2009	1		UNK	PUB						1						1	Abdominal pain; Abdominal pain upper; Decreased appetite; Dizziness; Dyspnoea; Fatigue; Nausea; Pain; Pruritus	FLU3~SANOFI PASTEUR~U3211AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358570	09/28/2009	GA	2.0	2	1	F	09/28/2009	Fever, runny nose and cough.  Fever for 3 days of 101-102.  Mom reports croupy cough									U	09/25/2009	09/25/2009	0	None	PVT	PVT	None	None	None			1						1	Cough; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500673P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0358571	09/28/2009	OH	57.0	57		F	09/28/2009	Began to have numbness, tingling, and muscle weakness in various parts of my body.  I was diagnosed with Guillian-Barre Syndrome.  10/1/09 Medical records received DOS 9/22/09 to 9/30/09. Assessment: watch Guillain Barre Syndrome. Patient c/o numbness (R) lateral leg and foot. Later (L) leg and foot. Soreness C7-T1. Weakness / Fatigue L3-L5, (R) Flx wrist.				Y					N	09/15/2009	09/16/2009	1	LABS and DIAGNOSTICS: Comprehensive Metabolic Panel WNL. Free T4 WNL. Lipid Panel WNL. TSH WNL.	UNK	UNK						1						1	Guillain-Barre syndrome; Hypoaesthesia; Muscular weakness; Paraesthesia; Guillain-Barre syndrome; Paraesthesia; UV light therapy	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0358573	09/28/2009	CA	42.0	42		F	09/28/2009	Redness around injection site soreness around injection site.										09/26/2009	09/28/2009	2		OTH	OTH						1						1	Injection site erythema; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98432P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358574	09/28/2009	OR	64.0	64		F	09/28/2009	Temp 101, body aches, headache, rash.				Y					Y	09/25/2009	09/26/2009	1		OTH	PVT		None				1						1	Body temperature increased; Headache; Pain; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA2JJBB~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0358575	09/28/2009	VA	39.0	39		M	09/28/2009	Small water filled blister at injection site no itchy or pain.									U	09/21/2009	09/22/2009	1		OTH	PUB	None	None	NKA			1						1	Injection site vesicles	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~9784AP~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358577	09/28/2009	WI	61.0	61		F	09/25/2009	Left forearm nerve twitching - muscle spasms- started after immunization, still happening, by the next day; still having twitching 28 Sep 9, slightly decreased spasms noted.									U	09/24/2009	09/24/2009	0		OTH	PVT						1						1	Muscle spasms; Muscle twitching	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~92846P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358578	09/28/2009	MI	73.0	73		M	09/28/2009	Day after shot; numbness in left hand, on top of hand (with slight discoloration - increased redness) this is the same arm injection was given.									U	09/24/2009	09/25/2009	1		OTH	OTH		None noted	NKDA - in good health			1						1	Erythema; Hypoaesthesia; Skin discolouration	FLU3~SANOFI PASTEUR~UC3172BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358579	09/28/2009	MI	71.0	71		F	09/28/2009	Joint pain, fever, finger tips throbbing. Started approximately 1 day after injection. Has been bed ridden.									U	09/24/2009	09/25/2009	1		OTH	OTH		None noted/ Arthritis	NKDA/Arthritis			1						1	Arthralgia; Bedridden; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U63172BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358582	09/28/2009	CA	65.0	65		F	09/28/2009	1/2 hour after shot my upper arms, chest and back broke out in rash and slight itching. Approximately 9 hours later (at 1am) I noticed my face was very swollen. The rash was very red, not too itchy. Face no rash slight red and rash on legs also. Doctor gave me a cortisone shot and Benadryl shot to take once / day.  Face and arms, chest back to normal				Y					Y	09/15/2009				OTH	PVT						1						1	Erythema; Rash erythematous; Rash pruritic; Swelling face	FLU3~SANOFI PASTEUR~43214AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358583	09/28/2009	FL	67.0	67		F	09/28/2009	Patient red rash through both arms legs, chest, shoulders.				Y					U	09/24/2009	09/25/2009	1	None	OTH	UNK		None	Allergies, DM, HTN, Hchol, Hormone Replacement			1						1	Rash erythematous	FLU3~SANOFI PASTEUR~U3208AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358584	09/28/2009	OR	11.0	11		M	09/28/2009	None stated.										09/28/2009				UNK	OTH	None	None				1						1	Inappropriate schedule of drug administration	FLU3~CSL LIMITED~05749111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358585	09/28/2009	OR	9.0	9		F	09/28/2009	None stated										09/28/2009				PVT	OTH	Multivitamin	None				1						1	Inappropriate schedule of drug administration	FLU3~CSL LIMITED~05749111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358586	09/28/2009	AK	84.0	84		F	09/28/2009	Patient broke out on an all-body rash that was severely itchy the night she hot the flu shot. It last for 2 days and recovered after treating with BENADRYL. She has also had diarrhea since the injection but is recovered now.									Y	09/22/2009	09/22/2009	0		OTH	OTH	No new medications	None	Aspirin; Codeine allergies; No known egg or thimerasol allergy			1						1	Diarrhoea; Pruritus; Rash generalised	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97842P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358587	09/28/2009	OR	14.0	14		F	09/28/2009	none										09/26/2009			none	PVT	UNK		none	Depression			1						1	Inappropriate schedule of drug administration	FLU3~CSL LIMITED~05749111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358588	09/28/2009	WI	33.0	33		F	09/27/2009	Patient left a message on the pharmacy voice mail that she received a flu shot 2 weeks ago and her arm still hurt.  She went to the doctor for other symptoms and mentioned to the doctor at the visit that her arm still hurt per call to nurse on 9/25/09.  Patient stated on voice mail that the shot was given in the shoulder and she hopes she does not need surgery.  I requested the patient call me back to discuss on 9/25/09.  But have not heard back yet.  MD advised patient to stop weight lifting.									U	09/14/2009				UNK	PVT		VAR did not indicate illness				1						1	Pain in extremity; Wrong technique in drug usage process	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358589	09/28/2009	WI	20.0	20		F	09/25/2009	Vaccine administered Friday 9/11/09. Patient had pain the night of vaccine, making difficult to sleep. Pain gradually subsided, then came back 9/18/09, and has been getting gradually worse. No redness, swelling at injection site. There is tingling in the arm, she cannot sleep on that side as arm will go numb. Painful at rest in shoulder. reaching, lifting arm up is worst pain. --> see back									U	09/11/2009	09/18/2009	7		OTH	PUB	ZEGERID, YASMIN	None	None			1						1	Hypoaesthesia; Insomnia; Musculoskeletal pain; Pain; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358594	09/28/2009	OR	19.0	19		F	09/28/2009	Given investigational vaccine. Follow-up: Inadvertently received a study vaccine.									Y	09/23/2009				PVT	PVT	None	None	Pregnancy			1						1	Drug exposure during pregnancy; Drug administered at inappropriate site; Drug exposure during pregnancy; Serology normal; Ultrasound scan normal; Wrong drug administered	FLU3~SANOFI PASTEUR~U012307~UNK~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~UD12307~1~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0358596	09/28/2009	NC	11.0	11		F	09/28/2009	Mom states patient complained of arm pain and swelling starting after going home 9-25-09 called office ANS. Srv. 9-26-09 PM- with soft ball sized area of redness hot and tender. Responded to symptomatic care of Ibuprofen and heat within 24 hours.									Y	09/25/2009	09/25/2009	0		PVT	PVT		None	None			1						1	Erythema; Oedema peripheral; Pain in extremity; Skin warm; Tenderness	FLUN3~MEDIMMUNE VACCINES, INC.~500673P~1~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U3058AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0358597	09/28/2009	VA	0.81	0	.8	F	09/28/2009	Mother called AM of 09/18/2009 to report baby was having reaction to vaccines. States she cried all night - only sleeping in 15 min episodes - feels warm to touch. Giving TYLENOL - no problem w/eating or drinking. PHN called mother in PM to check on child. Not really crying - but pouting - still hasn't checked temp - feels warm - wants to be held. No pediatrician yet - inst alternate TYLENOL w/MOTRIN to equal total of 4 doses/24 hours. PHN called Back 09/21/09 - child doing well - all shot sites warm to touch & red.									Y	09/17/2009	09/17/2009	0	None	PUB	PUB	None	None	None Known			1						1	Crying; Injection site erythema; Injection site warmth; Skin warm; Somnolence	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B213BA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT3174HA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF670AB~3~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~D48927~3~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0358598	09/28/2009	UT	33.0	33		F	09/28/2009	9/25/09 C/o When I lift my left arm it feels like ripping off tape, not every time just once in a while.  C/o slightly numbness to ankle area.  9/28/09 status symptoms are now gone.									Y	09/21/2009	09/25/2009	4	None	OTH	OTH		Denies	Asthma, allergies to grass, dust, dander, foods.			1						1	Hypoaesthesia; Pain	FLU3~SANOFI PASTEUR~U30244A~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358599	09/28/2009	MA	5.0	5		M	09/28/2009	Mom called child with erythema lesions around vaccination site was examined 6 cm x 4 cm erythema.				Y					Y	09/22/2009	09/23/2009	1		PUB	UNK						1						1	Injection site erythema	FLU3~SANOFI PASTEUR~V3188AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358601	09/28/2009	OH	55.0	55		F	09/28/2009	2 hours after receiving flu shot got pain in left arm (deep pain). Could not use arm. Used ice and ALEVE over the weekend. Rec'd X-ray Monday 9/23/09. Needs MRI.				Y					N	09/18/2009	09/18/2009	0	X-Ray, Impingement Lt rotator cuff area, Monday 9/23/09	OTH	PVT						1						1	Injected limb mobility decreased; Pain in extremity; Rotator cuff syndrome; X-ray abnormal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~978U0P1~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0358602	09/28/2009	TN	71.0	71		F	09/28/2009	Extreme pain in arm, hard to breathe, heart was pounding - felt like a heart attack, weak.  Called daughter - EKG was done, dr exam in urgent care!  Could not lift arm for over week - took MOTRIN.				Y					Y	08/11/2009	08/11/2009	0		PVT	PVT	LIPITOR; NEXIUM; CRENARIN;  SYNTHROID; ZOLPIDEM	No	Allergies			1						1	Asthenia; Dyspnoea; Electrocardiogram; Mobility decreased; Pain in extremity; Palpitations; Chest pain; Dyspnoea; Limb discomfort; Malaise; Palpitations	PPV~MERCK & CO. INC.~1163X~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1|FLU3~SANOFI PASTEUR~U3195AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0358603	09/28/2009	TX	80.0	80		F	09/28/2009	Shortness of breath, nausea, heavy/tight chest.									Y	09/04/2009	09/04/2009	0	None	OTH	PUB	None on file	None	Asthma	same~Influenza (Seasonal) (Fluzone)~1~79.00~Patient		1						1	Chest discomfort; Condition aggravated; Dyspnoea; Nausea	FLU3~SANOFI PASTEUR~U3200AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358606	09/28/2009	IN	68.0	68		F	09/28/2009	2 round red painful ring around site of injection. After 2 days increased to 3 inches at day 3.				Y					Y	09/25/2009	09/26/2009	1		OTH	PVT		None	Allergic to PCN and codeine			1						1	Injection site erythema; Injection site pain	FLU3~CSL LIMITED~0654911A~UNK~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~0037Y~UNK~SC~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358608	09/28/2009	MA	48.0	48		F	09/28/2009	I have a rash under the shot, and my arm still hurts.  I got the shot on Fri. the 25th of Sept.									N	09/25/2009	09/25/2009	0		MIL	PVT	None	None	None			1						1	Injection site rash; Limb discomfort	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA447BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0358610	09/28/2009	TX	18.0	18		F	09/28/2009	Swollen eyes and lips. Recovered with/ OTC'S.									Y	09/16/2009	09/16/2009	0	None	OTH	PVT	None	None	None			1						1	Eye swelling; Lip swelling	FLU3~SANOFI PASTEUR~U3199AA~1~UN~AR~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358650	09/28/2009	CA	58.0	58		F	09/28/2009	I got the flu vaccine on 9/24/09 (Thursday) at about 5 p.m. I felt OK at that time and had no problems.  Within an hour, I was seeing floaters in my right eye. Also see flashes of light like a shooting star to right of eye when it is dark.  Went to Hospital Saturday but they didn't have equipment to check it so was sent to another Hospital and got there Sunday morning at about 2 a.m.  Was examined about 6 a.m., dilated etc.  They said vitreous fluid was detatched and was causing the floaters in my eye but my retina was not detatched.  Released with instructions to follow up with an eye specialist within 2 weeks.  They didn't connect it with the flu vaccine but I had no eye injury or other event that was known to cause it so thought I should report in case it was a side effect.  I still have the floaters and light flashes on Monday 9/28/09.									U	09/24/2009	09/24/2009	0	They just did visual inspection of the eye after dilating it.	UNK	UNK	synthroid, buspirone, metatoprol	none	hypothyroid, heart arrythmia, anxiety, sometimes anemia.			1						1	Myodesopsia; Ophthalmological examination; Photopsia; Vitreous detachment	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~20092010~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358781	09/28/2009	NY	31.0	31		M	09/25/2009	Patient developed maculopapular rashes to the extremities.  He was administered the flu vaccine on 09/15/2009 and he is also on CLOZAPINE and Valproic Acid.										09/15/2006	02/24/2009	893	CBC;  Chem 20 all normal	UNK	UNK			Patient had similar problems in 2008 when he also given the flu vaccine.			1						1	Full blood count normal; Laboratory test normal; Rash maculo-papular	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0358782	09/28/2009	VA	77.0	77		M	09/17/2009	The flu shot caused sickening headache, fever, body aches and debilitating hip pain (esp. at the rear of the hip). After several days the adverse effects mitigated; however, although the hip pain decreased, it persists.										09/09/2009	09/09/2009	0	Allergic to some anti-biotics (esp. Penicillin).	UNK	UNK			Alelrgic to some anti-biotics (esp. Penicillin)			1						1	Arthralgia; Drug hypersensitivity; Headache; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P2~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0357578	09/29/2009		13.0	13		F	09/28/2009	Initial report was received on 17 September 2009 from an investigator participating in a non-sponsored sanofi pasteur study. The investigator reported this event electronically to VAERS (VAERS ID # E-31873). A 13-year-old female subject with a history of reactive airway disease and nasal allergies had received an injection of FLUZONE SV 2009-2010, lot number U3200AA (route and site not reported) on the morning of 28 August 2009 through a school based influenza vaccination program. A short time later, the subject complained of a headache and a closed throat. Physical examination revealed an alert and oriented child in no evidence of respiratory distress and on auscultation, and she had clear breath sounds without wheezing. The emergency medical team (EMT) arrived at 13:25. Her initial vital signs revealed BP of 130/90, HR 100 beats/minute and 98% oxygen saturation. She was able to move air well, but was unable to take deep breaths. The subject was administered 50 mg of BENADRYL (suspension) and had no difficulty swallowing. Urticaria developed on her face and she complained of shallow breathing, tongue hurting, chest pain and difficulty swallowing. The subject was placed on 10 1/minute of oxygen by face mask. EMS (emergency medical services) arrived at 13:35 and transferred the subject via ambulance to the emergency department. At the time of transfer, the subject was off oxygen and in no distress. The final diagnosis was Urticaria with possible angioedema. The patient had been taking ADDERAL 20 mg and CLARITIN 10 mg daily; and FLONASE prn. According to the reporter, the event of urticaria and possible angioedema was serious and unexpected; and the event was determined by the investigator to be related to FLUZONE. The subject's recovery status was not reported. Documents held by sender: None.				Y					U	08/28/2009	08/28/2009	0	28/Aug/2009; EMT arrived at 13:25; initial vital signs - BP 130/90, HR 100 beats/min, oxygen saturation 98%.	UNK	UNK	ADDERAL; CLARITIN; FLONASE		The subject had a history of reactive airway disease and nasal allergies.		200904012	1						2	Chest pain; Dysphagia; Dyspnoea; Glossodynia; Hypoventilation; Throat tightness; Urticaria; Chest pain; Dysphagia; Dyspnoea; Glossodynia; Headache; Hypoventilation; Oxygen saturation normal; Throat tightness; Urticaria	FLU3~SANOFI PASTEUR~U3200AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U3200A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0357712	09/29/2009	AZ	80.0	80		F	09/18/2009	After vaccine administration (flu), patient became very ill - vomiting, B/P 78/40, pulse - pacemaker - 80. Called 911. EMS took pt to hospital.			Y	Y	Y				U	09/16/2009	09/16/2009	0	Unknown	PUB	PVT	UNK	Unknown	Unknown			1						2	Abdominal pain; Back pain; Blood glucose increased; Cold sweat; Endotracheal intubation; Hypotension; Metabolic acidosis; Nausea; Oxygen saturation normal; Pallor; Respiratory failure; Retching; Hypotension; Malaise; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P1~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P1~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Life Threatening,Hospitalisation	Influenza
0358572	09/29/2009	OK	51.0	51		F	09/29/2009	Muscle tightening, soreness, red knot moving down muscle of arm, 3 1/2 to 4 inch diameter red spot on skin shoulder soreness, muscle soreness, unable to use arm for 72 hours.				Y					U	09/24/2009	09/25/2009	1		UNK	UNK			High Blood Pressure, Diabetes, High Cholesterol			1						1	Erythema; Mobility decreased; Muscle tightness; Myalgia; Nodule; Pain	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0358623	09/29/2009	NY	9.0	9		F	09/29/2009	Redness and itchiness at injection site (L deltoid), extending from top of L arm to just above L elbow - Admin BENADRYL 25mg po.									Y	09/28/2009	09/28/2009	0		PVT	PVT		None	Rash on AMOXICILLIN			1						1	Injection site erythema; Injection site pruritus	FLU3~SANOFI PASTEUR~U3176DA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358626	09/29/2009	IN	85.0	85		F	09/29/2009	Vaccine administered on 9-22-2009. Patient called pharmacy at 9:20am 9-29-2009 and stated that her arm was still sore after vaccination. She has never experienced such soreness following previous flu vaccines. She stated her arm was sore when she moved it and it was not as bad if she was sitting still. She did mention use of heating pad and capzasin cream on arm. She also stated that pain did seem lessened compared to a few days ago, but was still sore.									U	09/22/2009	09/22/2009	0		UNK	UNK	Cardizem CD, metoprolol succ, celebrex, lipitor, cozaar, alendronate, dyazide		cardiac			1						1	Pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~96030 5p~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358627	09/29/2009	MD	28.0	28		F	09/29/2009	Right arm, evening of injection she had redness and pain. Redness increased in diameter. No fever or other symptoms. No decrease in range of motion.									Y	09/22/2009	09/22/2009	0		PUB	PVT		None	Seasonal allergies, asthma			1						1	Erythema; Pain in extremity	FLU3~SANOFI PASTEUR~U3192AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~062JY~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358628	09/29/2009	MI	45.0	45		F	09/23/2009	Headache (Frontal) and top 8 on 1-10 pain scale, constant ache. Erythema, induration ( 5 x 7 cm area) noted on Lt. upper arm injection sites. Took Ibuprofen 200mg at 1:00pm headache gone now. Advised to ice site and use OTC BENADRYL or ibuprofen.									Y	09/21/2009	09/23/2009	2		PVT	PVT	Tamoxifen		Breast Cancer, 2008			1						1	Headache; Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~U3190AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358629	09/29/2009					U		fever														UNK	UNK						1						1	Pyrexia	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~~UNK~~~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0358631	09/29/2009	PA	16.0	16		F	09/24/2009	Fever, headache. Thrombocytopenia, neutropenia. Admitted, no treatment. 10/7/09 Medical records received from dates 9/8/09 to 9/10/09 DC DX: Leukopenia, thrombocytopenia.  Presenting SX:  fever, neck pain/stiffness, myalgias, sweats, chills, HA, nausea, poor appetite. Symptoms occured  x1 day after flu vaccine. ICD9 codes: 288.5, 287.5  11/30/2009 MR and DC summary for 9/10-9/11/2009 transfer to this facility for continued care, received IV ABX, DC Dx fever/headache, thrombocytopenia, neutropenia				Y	Y	2			Y	08/24/2009	09/07/2009	14	Influenza (-); WBC = 1.6; Platelet count = 66; CMV +; EBV negative 10/7/09 Medical records received from dates 9/8/09 to 9/10/09 Diagnostics/Labs: CT head(-), Lyme screen(-), CSF cx(-), WBC 1.6(L), bands 43%(H), CRP 92.5(H), RBC 3.95(L), platelets 66(L), HCT 35.7(L) neutrophils .5(L), LFT's abnormal-Albumin 2.9(L), protein 5.5(L), bili total .2(L), SGOT/AST 44(H), SGPT/ALT 35(H).	PVT	PVT	None	None	None 10/7/09 Medical records received from dates 9/8/09 to 9/10/09 PMH: none			1						1	Cytomegalovirus test positive; Epstein-Barr virus test negative; Headache; Influenza serology negative; Neutropenia; Platelet count decreased; Pyrexia; Thrombocytopenia; White blood cell count decreased	FLU3~SANOFI PASTEUR~U3173AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0358633	09/29/2009	MD	4.0	4		F	09/23/2009	After immunization listed below, developed (15 min later) wheezing, lip swelling, respiratory distress, hypoxia. Required epinephrine, albuterol, BENADRYL, prednisone, H2 blocker. Oxygen. Required hospitalization. L arm urticaria.  Records received 10/12/09.  Dates of Service 9/22/09-9/23/09.  Assessment:  Anaphylaxis.  Pt. seen for well child exam and received vaccinations.  5-10 min. later she c/o not feeling well, developed a cough, was thrusting her tongue, and had difficulty breathing as evidenced by abdominal and suprasternal retractions.  Child's lips became swollen, her mouth was foaming with a mucous like substance.  A diffuse erythematous rash developed as well as a welt on her left upper arm.  She was treated in the PMD's office with epinepherine x 2, supplemental oxygen and albuterol.  In the ED that patient received Benadryl, famotidine, solumedrol and albuterol nebs.  The Pt. was monitored in the hospital for one day, and at discharge had minimal evidence of swelling around her lips, no signs of rash or urticaria, no respiratory distress and was feeling well. ICD 9 Codes:  458.0, 493.90, 493.91, 682.0, 995.0, 995.20, 458.0, 477.9, 478.19, 479.25, 493.90,. 493.91, 495.8, 682.0, 691.5, 692.9, 696.9, 706.0, 782.1, 786.09, 785.09, 788.09, 786.2, 787.01, 787.02, 787.5, 995.0, 995.20, 995.3, V15.09, V15.09.			Y	Y	Y	1			Y	09/22/2009	09/22/2009	0	Labs and Diagnostics:  T:  97.8, P:  151, R: 54, SaO2: 91%.	PVT	PVT	PULMICORT; Albuterol		Asthma; allergies to Peanuts and Tree Nuts  PMH:   Respiratory difficulties at birth that quickly resolved,  asthma, food allergies to chick peas, peanuts, tree nuts, lentils, seasonal allergies to ragweed and pollen, GERD, recurrent UTI's, febrile seizure, NKDA.			1						1	Hypoxia; Lip swelling; Respiratory distress; Urticaria; Wheezing; Altered state of consciousness; Crying; Drooling; Dyspnoea; Foaming at mouth; Heart rate decreased; Injection site urticaria; Lip blister; Lip swelling; Oral pruritus; Pyrexia; Rash generalised; Use of accessory respiratory muscles	DTAP~SANOFI PASTEUR~C3157A~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U3199A~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~D0039~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0765Y~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1037Y~2~SC~LA~VARICELLA (VARIVAX)~1|DTAP~SANOFI PASTEUR~C3157A~5~IM~LA~DTAP (DAPTACEL)~2|FLU3~SANOFI PASTEUR~63199A~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|IPV~SANOFI PASTEUR~D0039~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~2|MMR~MERCK & CO. INC.~0765Y~2~IM~LA~MEASLES + MUMPS + RUBELLA (MMR II)~2|VARCEL~MERCK & CO. INC.~1037Y~2~IM~LA~VARICELLA (VARIVAX)~2	USA	Life Threatening,Hospitalisation	Influenza
0358633	09/29/2009	MD	4.0	4		F	09/29/2009	Shortness of Breath, Retracting, Swollen blistering lips, itchy tongue, foaming of the mouth, low pulse rate, rash all over her body, huge welt on her left arm at the site of vaccinations, fever, crying, excessive drooling, lack of awareness			Y	Y	Y				Y	09/22/2009	09/22/2009	0	No lab work done	PVT	UNK	Pulmicort 1mg/2ml in nebulizer & Albuterol Sulfate Inhalation Solution 0.5% 5mg/ml	Onset of cold on 9/19/2009	Asthma, food allergies to peanuts, tree nuts, legumes (chickpeas & lentils), innocent heart murmur			1						2	Hypoxia; Lip swelling; Respiratory distress; Urticaria; Wheezing; Altered state of consciousness; Crying; Drooling; Dyspnoea; Foaming at mouth; Heart rate decreased; Injection site urticaria; Lip blister; Lip swelling; Oral pruritus; Pyrexia; Rash generalised; Use of accessory respiratory muscles	DTAP~SANOFI PASTEUR~C3157A~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U3199A~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~D0039~4~SC~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0765Y~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1037Y~2~SC~LA~VARICELLA (VARIVAX)~1|DTAP~SANOFI PASTEUR~C3157A~5~IM~LA~DTAP (DAPTACEL)~2|FLU3~SANOFI PASTEUR~63199A~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|IPV~SANOFI PASTEUR~D0039~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~2|MMR~MERCK & CO. INC.~0765Y~2~IM~LA~MEASLES + MUMPS + RUBELLA (MMR II)~2|VARCEL~MERCK & CO. INC.~1037Y~2~IM~LA~VARICELLA (VARIVAX)~2	USA	Life Threatening,Hospitalisation	Influenza
0358635	09/29/2009	FL	57.0	57		M	09/23/2009	High fever, renal failure, cardiac problems, brachial neuritis, hydrocele, dialysis, cardiac inversion to sinus node rhythm, several heart medications.  10/05/09 Hospital records received service dates 9/12/09 to 9/22/09. Assessment: Acute renal failure, scrotal edema, hypertension, encephalopathy, rhabdomyolysis. Patient initially had flu-like symptoms. Patient presents with rales, fever, and penile / scrotal swelling. Severe weakness and acute renal failure. Tachycardia, decreased breath sounds. Peripheral edema. Red torso and neck skin. Renal dialysis initiated. Altered mental status.  ICD-9 Codes: 584.9 Acute renal failure, 348.30 Encephalopathy, 728.88 Rhabdomyolysis, 427.32 Atrial flutter, 008.45 Intestinal infection C. dif., 608.86 Male genital organ edema, 278.00 Obesity, 276.9 Electrolyte and fluid disorder, 401.9 Essential hypertension, 780.60 Fever, 603.9 Hydrocele, 427.31 Atrial fibrillation.			Y	Y	Y	10		Y	N	09/08/2009	09/09/2009	1	CT Scans; ultrasounds; Blood tests. 10/05/09 Hospital records received service dates 9/12/09 to 9/22/09. LABS and DIAGNOSTICS: EKG - Atrial fibrillation, RBBB. Echocardiogram - Abnormal. Chest X-ray - Abnormal. CT Chest Abnormal. CT Abdomen / Pelvis - Abnormal. US Scrotum - Abnormal. Urinalysis - Cloudy, occult blood (4+), Protein trace, Epithelial cells moderate, Bacteria many, Calcium Oxalate cryst few. CBC - WBC 21.7 Thou/UL (H) RBC 3.87 Mill/UL (L) Hemoglobin 12.1 G/DL (L) Hematocrit 34.4% (L) RDW 14.8% (H) Neutrophil 94% (H) Lymphocytes 4.5% (L). INR 1.7 (H). CHEM - CO2 21 MMOL/L (L) Random Blood Sugar 129 MG/DL (H) BUN 101 MG/DL (H) Creatinine 7.9 MG/DL (H) Calcium 8.0 MG/DL (L) AST 86 U/L (H) ALT 69 U/L (H) HDL 17 MG/DL (L) LDH 285 IU/L (H) Albumin 2.5 GM/DL (L) Total Protein 6.0 GM/DL (L) CPK 5644 IU/L (H) CPK MB 9.8 NG/ML (H) Troponin I 1.280 NG/ML (H). Blood cultures (-). Sputum Culture (+) Yeast.	OTH	OTH		None	None. 10/05/09 Hospital records received service dates 9/12/09 to 9/22/09. Obesity, hypertension. Chronic back pain, degenerative joint disease, C-spine fusion. Heart murmur. Carpal tunnel syndrome surgery. Nephrolithiasis.			1						1	Cardiac disorder; Dialysis; Hydrocele; Pyrexia; Radiculitis brachial; Renal failure; Sinus arrhythmia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97844P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0358639	09/29/2009	FL	44.0	44		F	09/29/2009	Persistent soreness, tenderness pain continuing over for over 14 days after vaccination. Unable to use arm to lift.				Y					U	09/12/2009	09/25/2009	13		UNK	PVT						1						1	Mobility decreased; Pain; Tenderness	FLU3~SANOFI PASTEUR~U3176DA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358641	09/29/2009	SC	30.0	30		F	09/29/2009	VACCINE GIVEN AT 9-28-09 @ 16:00. REPORTED FEELING LIPS TINGLING AND LIKE THEY WERE SWELLING, BUT NO SWELLING ACTUALLY NOTED. ALSO HAD CHILLS. REPORTED THAT WHEN SHE WOKE THIS AM 9-29-09 HER FACE AND LIPS WERE VISIABLY SWOLLEN. NO TREATMENT. BUT WAS INSTRUCTED TO TAKE SOME BENADRYL.									Y	09/28/2009	09/28/2009	0	NONE	UNK	UNK		NONE	ALLERGIC TO SULFA			1						1	Chills; Lip swelling; Paraesthesia oral; Swelling face	FLU3~SANOFI PASTEUR~U3209AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358642	09/29/2009	GA	53.0	53		F	09/29/2009	SWELLING AND PAIN AT INJECTIONS SITE WHICH STARTED WITH IN 24 HRS.  SITE IS STILL SWOLLEN, 7 X 6 CM, 48 HRS AFTER VACCINE ADMINISTRATION.									U	09/27/2009	09/28/2009	1	NONE AT THIS TIME.	PVT	PVT	NONE	NONE	PCN, BACTRIM			1						1	Injection site pain; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA284AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0358643	09/29/2009	IL	25.0	25		F	09/29/2009	Patient c/o headache, nausea and weakness 2 minutes after getting the FluMist vaccine. Patient reported vomiting one time in the afternoon.  Patient taken to ED on 23Sep09 and arrived at 1100. Patient diagnosised with Medication Reaction and given Zofran for nausea and discharged at 1310 in stable condition and medically cleared.				Y					Y	09/23/2009	09/23/2009	0	None	MIL	MIL	None	None	None			1						1	Asthenia; Headache; Nausea; Vaccination complication; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500691P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0358645	09/29/2009	FL	60.0	60		M	09/29/2009	CLIENT RECEIVED PNUEMOCOCCAL VACCINE AND FLU VACCINE ON THE 9/24/09 IN THE RIGHT DELTOID. THE FLU VACCINE WAS GIVEN AT 10:33AM AND THE PNEUMOCOCCAL WAS GIVEN AT 10:34AM. ON 9/26/09 IT WAS NOTICED THAT THE RIGHT ARM WAS RED,HOT AND EDEMATOUS.									U	09/24/2009	09/26/2009	2		PUB	UNK	TRICOR,FLEXERIL,HEPARIN FLUSHES,K-DUR,CEFTRIAXONE,VANCOMYCIN,COUMADIN,DILUADID,FERROUS SLUFATE,ZITHROMAX,COREG,MORPHINEPROTONIX,LEVAQUIN,MAG-OX,PERCOCET,NEURONTIN,ALLOPURINAL,IMDUR,ELAVIL,TERAZOSIN,XANAX,LIPITOR,REGULAR HUMAN INSULIN, FLORI	CHRONIC LOWER BACK PAIN	ALLERGIES TO ANTI INFLAMMATORY AGENTS.PRE EXISTING MEDICAL CONDITIONS OF CHF, DEFIBRILLATOR AND PACEMAKER, RHEUMATOID ARTHRITIS, COPD,GASTRIC REFLUX, DIVERTICULITIS WITH COLOSTOMY, CORONARY BYPASS SURGERY, ROTATOR CUFF REPAIR, MARIJUANA USE, ONE MONTH LOWER BACK PAIN.			1						1	Injection site erythema; Injection site oedema; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU468CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358646	09/29/2009	GA	38.0	38		F	09/29/2009	Swelling and redness to injection site 30 minutes after injection. Refused to go to ER. Went home and took Benadryl. No other symptoms at that time. Area red, hard and swollen the next day.									Y	09/28/2009	09/28/2009	0	none	PUB	PVT	Symbalta, Naproxen	none	Allergic to Penicillin, Sulfa, Morphine.			1						1	Injection site erythema; Injection site induration; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA468CA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0358648	09/29/2009	MO	89.0	89		F	09/29/2009	Red splotches the entire length of injection arm.  Inside the red splotches are small blisters.  The arm has continued to be sore.				Y					U	09/17/2009	09/24/2009	7	None at this time.	UNK	PUB	Lyrica 50mg, gabapentin 800mg, diovan 160mg, furosemide 40mg, levothyroxine 125mcg, verapamil 120mg	none noted				1						1	Injection site erythema; Injection site vesicles; Pain in extremity; Rash macular	FLU3~SANOFI PASTEUR~UB177BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358649	09/29/2009	MD	23.0	23		F	09/29/2009	muscle aches, fever to 101, nausua that started within 3hours of administration and lasted for 5 days+ (still resolving).				Y					N	09/24/2009	09/24/2009	0	CBC, ESR, RF, ANA, CRP, C3D, C3/C4 CMP	MIL	MIL		None	None (but similar reactions on 2 prior flu vaccines)			1						1	Antinuclear antibody; C-reactive protein; Complement factor C3; Complement factor C4; Full blood count; Metabolic function test; Myalgia; Nausea; Pyrexia; Red blood cell sedimentation rate; Rheumatoid factor	FLUX~UNKNOWN MANUFACTURER~~4~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0358651	09/29/2009	OH	70.0	70		M	09/21/2009	After shot he left and went home then wife brought back immediately. Patient's tongue swollen and trouble breathing. Also had shakes. I administered an epipen 0.3mg and called 911. EMS took him to hospital where he spent 24 hours.  10/30/2009 hospital records for 9/18/2009.Dx possible allergic reaction to vaccine  patient with  c/o's rash, itiching, hives, throat swelling, chest tightness, and SOB. Tx: IV Solu Medrol, Benadryl and Pepcid.				Y	Y	1			Y	09/18/2009	09/18/2009	0	none Labs: CBC;  hgb, hct and rbc low, neutrophils high, BMP: norm, UA norm Dx studies: EKG norm	OTH	PUB		no	no PMH High Cholesterol, MI post CABG Allergies: Sulfa and Demerol			1						1	Dyspnoea; Swollen tongue; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0358652	09/29/2009	LA	6.0	6		F	09/18/2009	Right arm where vaccine was administered swelled 2x size. Patient then developed thrombocytopenia ITP received IV Igg. Platelet count dropped to 3,000. Hospitalized 9/14/09. 10/5/09 Discharge summary received for dates of service 9/13/09 to 9/15/09. DX: Immune thrombocytopenia purpura.  Presenting Symptoms: presented with a four day history of increased petechiae over both arms, trunk, and neck. Purpura on both Periorbital sufaces. Pt started on IVIG. Pt experienced HA, emesis x1 as side effect of tx.			Y		Y	3			U	09/09/2009	09/10/2009	1	Platelet Count: 3000 10/5/09 Discharge summary received for dates of service 9/13/09 to 9/15/09. Diagnostics/Labs: WBC 10.08(H), HgB 12.7(WNL), platelets 3-37(L), ESR 35(H), IgG,IgA,IgM WNL	PVT	PVT		none	ADHD			1						1	Blood product transfusion; Idiopathic thrombocytopenic purpura; Injection site swelling; Platelet count decreased; Blood product transfusion; Contusion; Idiopathic thrombocytopenic purpura; Petechiae; Platelet count decreased	FLU3~SANOFI PASTEUR~U3204AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U3204A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Life Threatening,Hospitalisation	Influenza
0358653	09/29/2009	MA	64.0	64		F	09/09/2009	Nausea, vomiting, extensive swelling LUE where vaccine was administered. 12/11/09 PCP Medical Records received for DOS 09/04/09- 09/06/09 Pt presented with upper left arm swelling, nausea and vomiting day after receiving vaccines.  Arm is red and difficult to move.  Sent to ER for evaluation. Pt. admitted. and treated with antibiotics. DX: ? cellulitis   12/22/09 Pulmonary consult and chest CAT received for DOS 11/02/2009-11/06/2009. DX: Refractory cough  Patient presents with post-tussis vomiting once a week and reports vague symptoms of esophageal reflux. Patient first seen four months ago for chronic cough, which has now worsened and shortness of breath with exertion, which has not progressed.   12/28/2009 Clinic follow-up progress note and duplicate immunization record received for DOS 09-03-2009 and 09/2009. Dx: Allergic reaction to flu vaccine. Patient received pneumovax and flu vaccine and upon returning home felt nauseous and developed vomiting. The next day presented with left upper arm swelling and was admitted. Treated with antibiotics and discharged on KEFLEX. Arm pain and arm swelling completely resolved.				Y	Y	2			Y	09/03/2009	09/03/2009	0	12/11/09 Diagnostics: Ultrasound left arm: no fluid collection or mass Labs: Blood culture: no growth 12/22/2009 Diagnostics: Chest CAT: Airway malacia and stable interstitial abnormalities compatible with NSIP./rem 12/28/2009: Diagnostics: Ultrasound: no fluid collection/rem	PUB	UNK		None	12/11/09 PMH: GERD; dyslipidemia; mild renal failure			1						1	Extensive swelling of vaccinated limb; Nausea; Pain in extremity; Vaccination complication; Vomiting	FLU3~SANOFI PASTEUR~U3188AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1435X~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0358654	09/29/2009	PA	42.0	42		F	09/21/2009	Pt. reported itching and swelling in ankles and top of feet within 2 hrs of injection. It progressed to her wrists, knees and elbows. On Sat 9/19 she started using BENADRYL, but hives became more generalized on Sun to cover area's of her trunk, scalp and ears. She also reported chest tightness for several hrs on Sun. Dr called. CLARITIN and low dose corticosteroids prescribed.				Y					Y	09/17/2009	09/17/2009	0	None	PVT	OTH	PREVACID; YAZ	None	None. Oct melanoma 2008			1						1	Chest discomfort; Joint swelling; Oedema peripheral; Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~FLUA460AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0358655	09/29/2009	MN	55.0	55		F	09/21/2009	Sore arm 10 days post injection.									Y	09/03/2009	09/15/2009	12	None	PVT	PVT		none	Latex			1						1	Pain in extremity	FLU3~CSL LIMITED~06449111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358656	09/29/2009	FL	63.0	63		F	09/07/2009	Hives roughly 30 - 40 with vaccine. Pt took 1.25 mg BENADRYL. Rxt not us red. Told pt to report Q4-6 hr and call PCP tomorrow - Upon discussing allergies at time of vaccination, pt stated had none by marking VAR consent box no. After pt came in about 5pm - states she may have had a topical rxt to neomycin, in NEOSPORIN, but has never had it internally. Then went onto state at this time, 5pm - has codeine allergy and possible allergy to some antibiotics but doesn't know which ones. Also stated she is an RN and had shot before w/no rxt at time of vaccine. Called pt  9/20/09 430 pm - Pt states she continued use of BENADRYL x 2 days and rash was resolved after 3 days. Pt also states she had the flu at age 45yo and took shot yrly until present w/o any reaction.									Y	09/07/2009	09/07/2009	0	None	OTH	PVT	None	None	Allergic to codeine - think possibly an antibiotic	None~ ()~~0.00~Patient		1						1	No reaction on previous exposure to drug; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97844Pl~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358657	09/29/2009	VA	0.92	0	.9	M	09/18/2009	None stated.									Y	09/18/2009	09/18/2009	0	Pt sent to allergist	PVT	UNK						1						1	Unevaluable event	FLU3~SANOFI PASTEUR~UT3171CA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358659	09/29/2009	IL	35.0	35		F	09/23/2009	Pt felt soreness in muscle following injection and is now continuing 1 wk post injection. No redness, swelling or warmth at injection site or in arm. Pt also notes numbness in arm. Pt says after her vaccination, she returned directly to work which includes a lot of heavy lifting. Referred pt to her primary care physician.									U	09/16/2009	09/16/2009	0	None	OTH	PVT	None	None	NKDA/ defects/ conditions			1						1	Hypoaesthesia; Myalgia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358660	09/29/2009	WI	62.0	62		F	09/17/2009	Pt complains of a sore left shoulder.  Received injection (FLUVIRIN) 9/1/09 still having problems as of 9/17/09.  Pt called 9/8 saying she had a problem with her arm.  I told her to see her doctor.  Prescriber prescribed VOLTRAN gel and told the patient had she not come in the soreness could have traveled to her bone.  Prescriber said the pt received the injection into a tendon (according to the patient).  Prescriber APNP saw the patient on 9/17/09 and talked to her at 3:50 pm  9/17.  She said there is no sign of infection, that the tendon was not infected that it appears to be IM myofascitis: The patient has been guarding the arm and prescriber is sending her to therapy (PT).  She observed the point of injection and that the injection site was correct.  She expects the situation to resolve in a couple of weeks.  The inflammation has spread a little but not to the tendon or bone as the patient described.									N	09/10/2009	09/14/2009	4		OTH	PVT		None				1						1	Inflammation; Musculoskeletal pain; Myofascitis; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358662	09/29/2009	CA	67.0	67		F	09/18/2009	Recv'd PNEUMOVAX right deltoid in 9/17/09 FLUVIRIN left deltoid 9/17/09.  Complained of a sore shoulder while driving - a few hours after vaccination.  9/18/09 call to pt - still w/ shoulder - upper arm pain.									U	09/17/2009	09/17/2009	0		OTH	PVT		None				1						1	Arthralgia; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0627Y~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358663	09/29/2009	MT	58.0	58		F	09/18/2009	Body Rash-Prominent Lower Abdominal especially on and around scar.									Y	09/17/2008	09/17/2008	0		PVT	UNK		No	Post R Breast			1						1	Rash; Rash generalised	FLU3~SANOFI PASTEUR~U3193AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358664	09/29/2009	FL	26.0	26		F	09/21/2009	Immediately after receiving injection, she developed hives, approx 30 minutes later she develop shortness of breath and tachycardia. She was taken to ER. Treated with BENADRYL IV, solumedrol IV.				Y					Y	09/19/2009	09/19/2009	0		PUB	UNK		none	none			1						1	Dyspnoea; Tachycardia; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA470AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0358665	09/29/2009	OH	67.0	67		M	09/21/2009	Pt received PNEUMOCOCCAL & influenza virus vaccines at 10:30 am 9/19/09.  About 4 hours later he noticed injection sites were getting very sore.  Late 9/20 the arm became red, hot and hard.  Today (9/21) it is sore, hot, and he cannot raise it over 90 degrees.  Pt going to PCP at 10:15 am.  Pt was given 2 prescriptions for antibiotics & told to go to hospital if no improvement w/in 2 days.									U	09/19/2009	09/19/2009	0		OTH	OTH	CELEXA; SINEINET.	None				1						1	Erythema; Injected limb mobility decreased; Injection site pain; Skin induration; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2A~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0627Y~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358666	09/29/2009	AR	31.0	31		F	09/29/2009	States she started having whelps approx. 1 to 1 1/2 hours after rec. the vaccine. 10/19/2009 records from ED visit 9/24/2009 and records from Inpatient admit 9/27-9/29/2009.  DC Dx: Allergic reaction to flu vaccine.   Patient initial sx of rash, itching and facial swelling post vaccine tx'd at ER with IV Solumedrol, Benadryl, and Pepcid. Patient returned to ED 3 days later with c/o's difficulty swallowing, feeling like throat closing and difficulty breathing. Admit to Telemetry, tx'd with IV steroids, benadryl, pepcid and racemic epinephrine neb tx's.10/20/2009 received ICD-9 codes: 693.0, 401.9, E949.6, 250				Y	Y	2			Y	09/24/2009	09/24/2009	0	Labs: CBC: wbc 11.8, neutrophils 10.3, platelet ct 455  all high , hct 32.6, hgb 10.9 both low, CMP WNL except Glucose 131  Dx studies: Ct neck normal, EKG tacchycardia	OTH	UNK		none	PMH: Type II DM Allergies: Celebrex			1						1	Urticaria; Burning sensation; Dyspnoea; Pruritus; Rash; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA282AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1|FLUX~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0358666	09/29/2009	AR	31.0	31		F	09/29/2009	Rash and itching started within one hour of vaccine. Went to store to get Benadryl. Face started welting and burning. Immediately took two benadryl. Got home and within 20 minutes had trouble breathing. Family rushed me to ER. Received epi, steroids, benadryl, and breathing treatement to open airway. Went home 3 hours later. Rushed back 3 days later and was admitted to hospital. Still on medications to keep side affects at bay.				Y	Y	2			Y	09/24/2009	09/24/2009	0		UNK	PVT			allergic to celebrex; Type 11diabetes			1						2	Urticaria; Burning sensation; Dyspnoea; Pruritus; Rash; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA282AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1|FLUX~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~2	USA	Hospitalisation	Influenza
0358669	09/29/2009	TX	8.0	8		F	09/29/2009	Started with a cold sore the wk of 9/7-9/14/09, red dots to tight cheek, pt c/o pain to rash, rash spread over the eye and eye lash; meds prescribed acyclovir and prednisone.				Y					U	02/16/2007	09/07/2009	934		PVT	PVT	ZYRTEC allergy tabs	none	none			1						1	Oral herpes; Pain; Rash erythematous	FLUN3~MEDIMMUNE VACCINES, INC.~500445P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~1145F~2~SC~~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0358672	09/29/2009	RI	64.0	64		F	09/16/2009	Pt contacted clinic on the day after the vaccine was administered -stated c/r felt pain up her neck and back following administration - As the evening progressed she felt muscle pain throughout her body and headache. Clinic advised her to contact her physician. Physician advised MOTRIN. Pt stated symptoms resolving										09/14/2009	09/14/2009	0		UNK	UNK		None	Fibromyalgia			1						1	Back pain; Headache; Myalgia; Neck pain	FLU3~CSL LIMITED~02649211A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358673	09/29/2009	TX	5.0	5		M	09/23/2009	Injection site reaction. Papules at site in circle approx. 3 in diameter.									U	09/19/2009	09/20/2009	1		OTH	PVT	SINGULAIR, FLOVENT, NASONEX, ALBUTEROL		Rash with PCN, seasonal allergies			1						1	Injection site papule; Injection site reaction	FLU3~SANOFI PASTEUR~U3191AA~5~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358676	09/29/2009	VA	57.0	57		M	09/29/2009	PT states he began to feel itchy about 3 hrs after vaccine administration. 9/16 he noticed rash on arms legs groin area with swelling of feet, hands. He also noticed tightness in his throat. But not severe. He applied BENEDRYL spray to rash. On 9/17 he has noted decreased swelling of hands feet and improvement of rash. No resps x or swelling sens in throat.									U	09/15/2009	09/15/2009	0		OTH	OTH	Meds for DM2 and Cholesterol	No	DM2 increased Cholesterol	N/U add pain rash~Tdap (no brand name)~UN~43.00~Patient		1						1	Oedema peripheral; Pruritus; Rash; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA449BA~2~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0358677	09/29/2009	CA	64.0	64		M	08/17/2009	Transient (2 wks.) diplopia with probable 6th nerve palsy.									Y	11/14/2006			None	PVT	UNK		None	None			1						1	Diplopia; VIth nerve paralysis	FLUX~UNKNOWN MANUFACTURER~~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0358678	09/29/2009	TX	81.0	81		M	09/29/2009	Pt appeared to have quite a bit of bleeding at injection site and down arm (left) also itching at site and on neck area.									U	09/25/2009	09/25/2009	0	None	OTH	PUB	PLAVIX; Blood pressure; baby ASA	None	Surgery on nose 2 wks prior			1						1	Injection site haemorrhage; Injection site pruritus; Pruritus	FLU3~SANOFI PASTEUR~U3199AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358679	09/29/2009	WI	46.0	46		F	09/27/2009	Patient called clinic one day after vaccine given to report that 4 hours after vaccine given patient had symptoms of coughing, sore throat, itchy eyes/body aches and pains, pain in her eyes. She took BENADRYL and TYLENOL and felt better.									Y	09/26/2009	09/26/2009	0	None	OTH	UNK		None	No allergies listed on form			1						1	Cough; Eye pain; Eye pruritus; Oropharyngeal pain; Pain	FLU3~SANOFI PASTEUR~U3214AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358680	09/29/2009	GA	26.0	26		M	09/17/2009	Pt. received flu shot.  About 2-3 minutes later he passed out.  He immediately regained consciousness after falling & reported that he had not eaten in the past 15 hours due to religious celebration.				Y					Y	09/16/2009	09/16/2009	0		OTH	PVT	0	Fasting				1						1	Fall; Loss of consciousness	FLU3~SANOFI PASTEUR~U3212AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358681	09/29/2009	CA	69.0	69		M	09/14/2009	Dime - sized swelling/discoloration immediately after injection at injection site; ice pack applied, patient offered IBPROFEN but declined.									Y	09/14/2009	09/14/2009	0		OTH	PVT		None				1						1	Immediate post-injection reaction; Injection site discolouration; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~2~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358682	09/29/2009	MI	16.0	16		F	09/29/2009	Patient said she felt dizzy, slight trouble breathing, crying.  Did not turn into an allergic reaction.  ER said patient probably had symptoms triggered by anxiety - did not suspect an allergic reaction.				Y					Y	09/27/2009	09/27/2009	0		OTH	PVT	Unknown		Unknown			1						1	Anxiety; Crying; Dizziness; Dyspnoea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960304P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0358683	09/29/2009	MI	54.0	54		F	09/19/2009	Redness at injection site, itching, fever, throat swelling, breathing difficulty, dizziness, flushing, swelling of face.				Y					N	09/14/2009	09/15/2009	1	No	OTH	PVT	NAPROSYN	None	PENICILLIN			1						1	Dizziness; Dyspnoea; Flushing; Injection site erythema; Pharyngeal oedema; Pruritus; Pyrexia; Swelling face	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0358684	09/29/2009	NC	69.0	69		M	09/29/2009	Phone call from patient, had chills last PM.  Arm swollen from right deltoid to elbow.  Soreness, slightly warm.  Denies fever or severe reaction.									Y	09/28/2009	09/28/2009	0	None	PUB	PVT		None	None			1						1	Chills; Oedema peripheral; Pain; Skin warm	FLU3~SANOFI PASTEUR~U316AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1296X~4~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358685	09/29/2009	AK	61.0	61		F	09/21/2009	Chills, shaking, body aches, nausea, headaches, fatigue.									Y	09/15/2009	09/15/2009	0	None	OTH	PVT	B/P	No	Penicillin, strawberries			1						1	Chills; Fatigue; Headache; Nausea; Pain; Tremor	FLU3~SANOFI PASTEUR~U3177AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358686	09/29/2009	IL	74.0	74		M	09/20/2009	Pain in left shoulder.  Cannot lift arm over head for 2 weeks after.									U	09/02/2009	09/02/2009	0		OTH	PUB	COLCHINE; VYTORIN; ATENOLOL; TRIAMTERENE/HCTZ	None	None			1						1	Injected limb mobility decreased; Musculoskeletal pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840PI~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358690	09/29/2009	NJ	8.0	8		F	09/23/2009	High temp, abdominal pain.									Y	09/11/2009	09/12/2009	1	CBC, sed rate, abd. ultrasound	PVT	PVT		None	None			1						1	Abdominal pain; Body temperature increased; Full blood count; Red blood cell sedimentation rate; Ultrasound abdomen	FLU3~SANOFI PASTEUR~U3203~3~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358694	09/29/2009	TX	30.0	30		M	09/29/2009	noticed red spots then rash on groin area spreading to upper trunk and bilateral arms, with itching 11 days after receiving the flu vaccine for the first time									U	09/14/2009	09/25/2009	11		UNK	UNK			occasional skin rashes after eating shrimp			1						1	Pruritus; Rash erythematous	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA257CA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0358695	09/29/2009	NC	1.92	1	.9	F	09/29/2009	Patirnt developed hives 1 day after vaccine administration									Y	09/17/2009	09/18/2009	1		PVT	PUB						1						1	Urticaria; Urticaria	FLU3~SANOFI PASTEUR~UT3174GA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~UT3174GA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0358696	09/29/2009	PA	45.0	45		F	09/29/2009	Trouble breathing for about 12 hours.  Used inhaler (albuteral?)									Y	09/28/2009	09/28/2009	0		PVT	UNK	Cymbalta, Abilify, Welbutrin	None.	None.			1						1	Dyspnoea	FLU3~SANOFI PASTEUR~~UNK~~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358697	09/29/2009	CA	4.0	4		M	09/29/2009	Urticaria withing few minutes of administration, given Benadryl, but continued rapid progression, given Epinephrine im after about 5 minutes. Next day developed fevers.									Y	09/28/2009	09/28/2009	0		PVT	PVT	none	none	none			1						1	Pyrexia; Urticaria	DTAP~SANOFI PASTEUR~C3141AA~5~IM~RA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~UT3172BA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~D0304~4~IM~RA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0710Y~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0805Y~2~IM~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0358698	09/29/2009	IN	28.0	27		M	09/27/2009	C/O mild Headache, Slight Intermittent dizziness, abdominal cramping									Y	09/27/2009	09/27/2009	0	None	UNK	PVT	None	None	None			1						1	Abdominal pain; Dizziness; Headache	FLU3~CSL LIMITED~070849111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358700	09/29/2009	NY	41.0	41		F	09/29/2009	influenza vaccine administered approximately 8 pm on 9/25.  At approx. 1 AM on 9/26 Ivette felt warm and dizzy she had frank syncope and also vomited. In the emergency room she was found to be in rapid atrial fibrillation (150/min.)treated with fluids and a cardiazen drip.  She converted to sinus rhythm. 10/5/09 Hospital records and DC summary received for dates 9/26/09 to 9/27/09. DC Diagnosis: Syncopal episode, Atrial Fibrilation with rapid ventricular response.  Presenting symptoms: Pt received flu vaccine. Several hrs later pt. felt flushed, dizzy, and had a syncopal episode lasting several minutes. Pt vomited x1, then felt nausea. In ER pt. found to be in A-fib. Pt tx in ICU. Pt improved and DC the following day. ICD9 codes: 427.31, 276.8, 780.2, 288.60, 272.4				Y	Y	2			Y	09/25/2009	09/27/2009	2	serum K=3.3, troponin <0.04, <0.04, 0.06, HCG neg., Lyme IGG neg, WBC 16.1 at 0322 9/26 then 8.2 on 9/27 at 0430, Urine culture neg. 10/5/09 Hospital records and DC summary received for dates 9/26/09 to 9/27/09. Diagnostics/Labs: Echo-Normal, CT brain(-), CT chest(-), CXR(-), Troponin WNL, TSH WNL, K+ 3.3(L), triglycerides 355(H), HDL 34(L), VLDL 46-71(H), WBC 16.1(H), Lymphocytes 17(L), neutrophil% 86(H), lymphocyte% 12(L)	UNK	UNK		no	none 10/5/09 Hospital records and DC summary received for dates 9/26/09 to 9/27/09. PMH: Dyslipidemia, allergy to PCN, syncopal episode after having the flu in the past.			1						1	Atrial fibrillation; Blood potassium decreased; Borrelia burgdorferi serology negative; Culture urine negative; Dizziness; Pregnancy test negative; Skin warm; Vomiting; White blood cell count increased; Atrial fibrillation; Cardiac enzymes; Computerised tomogram; Dry eye; Echocardiogram; Electrocardiogram; Hypotension; Intensive care; Nausea; Ocular hyperaemia; Syncope; Vomiting; White blood cell count increased	FLU3~CSL LIMITED~08249111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|FLU3~CSL LIMITED~08249111a~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~2	USA	Hospitalisation	Influenza
0358702	09/29/2009	NJ	39.0	39		M	09/28/2009	Initial case received from a consumer, who is also the patient, on 16 September 2009. A 39-year-old male patient, with a history of penicillin allergy, received an injection of FLUZONE (lot number not reported) on 15 September 2009. Approximately four hours post-vaccination, he reported symptoms of occulo-respiratory symptoms, including red, teary eyes. He also reported muscle fatigue, tight throat, and chest congestion. Symptoms subsided, then became worse 13 hours post-vaccination. The patient reported photosensitivity, aches, and fatigue in addition to the symptoms previously experienced. The following morning the symptoms improved, and by 24 hours post-vaccination he reported only bloodshot eyes. Documents held by sender: None.				Y					N	09/15/2009	09/15/2009	0		UNK	UNK			Allergic to PENICILLIN; no other reported medical history.		200903962	1						1	Fatigue; Lacrimation increased; Muscle fatigue; Ocular hyperaemia; Oculorespiratory syndrome; Pain; Photosensitivity reaction; Respiratory tract congestion; Throat tightness	FLU3~SANOFI PASTEUR~~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358713	09/29/2009	MO	50.0	50		F	09/29/2009	Patient recieved flu shot on 9/23/09.  Noted swelling of the arm day after flu shot given.  Was seen on 9/25/09 by Dr.  Dr. noted swelling and erythema in the area where the shot was given.  Patient was advised to utilize ice and over the counter medications and to follow up if no expected resolution of symptoms.										09/23/2009	09/24/2009	1		UNK	UNK	Lisinopril, metoprolol, wellbutrin, reservatol	none	none known			1						1	Injection site erythema; Injection site swelling; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960312P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358718	09/29/2009	OR	7.0	7		F	09/29/2009	None stated.									U	09/21/2009				PVT	OTH	SINGULAR; PREVACID.		Articulation disorder; otitis media; seasonal allergies; dysuria.			1						1	Inappropriate schedule of drug administration	FLU3~CSL LIMITED~05749111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358720	09/29/2009	OR	6.0	6		M	09/29/2009	Pt never had a reaction to the flu vaccine.  Pt had received an adult dose.  That is the reason  it was reported.									U	09/21/2009				PVT	OTH	Motrin		Nasolacrimal duct obstruction.			1						1	Inappropriate schedule of drug administration	FLU3~CSL LIMITED~05749111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358722	09/29/2009	MI	37.0	37		F	09/29/2009	Patient felt increased heart rate, increased blood pressure, and flushing, a sense of doom and hyperventilating 5 minutes after receiving flu shot.  She was not at her place of work and was taken by stretcher to the ER.  They gave her the EPINEPHRINE, SOLUMEDROL, BENADRYL and PEPCID.  She was monitored for 3 1/2 hours and discharged in stable condition.  Her work place gave her the flu shot and she followed up in our office on 9-29-09.				Y					Y	09/28/2009	09/28/2009	0	None	PUB	OTH	None	None	Patient has no known drug allergies.  Allergic reaction NOS. Extrinsic Asthma; Allergic Rhinitis; Allergic conjunctivitis			1						1	Anxiety; Blood pressure increased; Flushing; Heart rate increased; Hyperventilation	FLU3~SANOFI PASTEUR~U3194AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358724	09/29/2009	OH	61.0	61		F	09/13/2009	Rash developed between legs & at waist the next night. Put on itch cream. Woke up in the early morning and called emergency doctor on call. He saw me in the morning and recommended a steroid pack. Same routine the next day so I filled the prescription and began meds.Resolved after steroids.				Y					Y	09/10/2009	09/11/2009	1	Saw doctor	OTH	PVT	Levoxine Amnytriptoline	None	CATS Hayfever			1						1	Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0358726	09/29/2009	MI	67.0	67		F	09/23/2009	Fatigue, 11 cm x 7 cm area on upper (R) bicep of erythema & warmth.									Y	09/21/2009	09/22/2009	1	None	PVT	UNK		None	Allergies to VYTORIN, PCN, PRAVACHOL, LIPITOR			1						1	Fatigue; Injection site erythema; Injection site warmth	FLU3~SANOFI PASTEUR~U3189AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~002Y~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358734	09/29/2009	CA	75.0	75		F	09/24/2009	Patient developed redness and swelling in elbow and lower arm area.									Y	09/22/2009	09/23/2009	1	None	OTH	PVT		None	None			1						1	Erythema; Joint swelling; Oedema peripheral; Joint swelling; Muscular weakness; Oedema peripheral; Pain in extremity; Rash erythematous	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97843PI~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1125X~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~00006494300~UNK~IJ~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~66521011110~UNK~IJ~LA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0358737	09/29/2009	CA	55.0	55		M	09/21/2009	Received flu vaccine at 12:00 noon on Saturday Sept 5.  Became ill at 1:00 pm on Sept 5.  Fever, headache, cough, nose congestion and chest congestion, vomiting, fatigue, sore body joints.  Some symptoms lasted 9 days.									Y	09/05/2009	09/05/2009	0	None	OTH	PVT	Albuterol sulfate aerosol for asthma	None	Asthma			1						1	Arthralgia; Cough; Fatigue; Headache; Malaise; Nasal congestion; Pyrexia; Respiratory tract congestion; Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0358740	09/29/2009	CA	56.0	56		F	09/21/2009	Received flu vaccine on Sept. 5 at 12:00 noon. Became ill by 1:00 PM Sept. 5, fever, cough, nose congestion, chest congestion, diarrhea, fatigue, sore body joints. Some symptoms lasted 12 days.									Y	09/05/2009	09/05/2009	0	None	OTH	PVT	METFORMIN; glyburide; lisinopril	None	Diabetes, high blood pressure			1						1	Arthralgia; Cough; Diarrhoea; Fatigue; Nasal congestion; Pyrexia; Respiratory tract congestion	FLUX~UNKNOWN MANUFACTURER~97840P011~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0358745	09/29/2009	FL	47.0	47		F	09/18/2009	Received shot on 9/16/09. Very dizzy by 9/18/09. Seen and treated in the ER.				Y					U	09/16/2009	09/18/2009	2	None	PUB	OTH	SYNTHROID; otc vits.; remifemen; PEPCID; ANTIVERT	None	Hypothyroid, hysterectomy			1						1	Dizziness; Balance disorder; Dizziness; Full blood count normal; Laboratory test normal; Nausea; Nuclear magnetic resonance imaging brain normal; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA470AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA470AA~1~SC~RA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Emergency room visit	Influenza
0358750	09/29/2009	LA	52.0	52		F	09/18/2009	9/18/09 12:30 AM woke up with nausea, muscle aches and HA - mild rx.  6:00 AM FBS 160 usually in the 90's in the AM.  Called her M.D. who told her to take TYLENOL and have this form filled out.  10:00 AM HA beginning to subside, no more body aches has not checked sugar but thinks its ok.  Physician did not want pt to come to office.									Y	09/17/2009	09/18/2009	1	None	OTH	PVT			Diabetes			1						1	Blood glucose increased; Condition aggravated; Headache; Myalgia; Nausea	FLU3~CSL LIMITED~08249111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358756	09/29/2009	CA				F	09/21/2009	Misadministration of expired vaccine. Patient was revaccinated with new product.									Y	09/15/2009				PVT	PVT						1						1	Expired drug administered	FLU3~CSL LIMITED~02749111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358758	09/29/2009	NY	55.0	55		F	09/29/2009	Patient felt flush and hot.  Diphenhydramine IM administered in the Emergency Room.				Y					Y	09/24/2009	09/24/2009	0		UNK	UNK						1						1	Feeling hot; Flushing; Flushing; Swelling face; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA449BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA449BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Emergency room visit	Influenza
0358759	09/29/2009	WI	46.0	46		F	09/29/2009	Received seasonal influenza vaccine and developed itching and rash on body, throat started to fell scratchy, cough, became hoarse became difficult to swallow and breathe. Went to be seen in ER and was treated				Y					Y	09/24/2009	09/25/2009	1	none	PUB	PVT	None	none	none			1						1	Cough; Dysphagia; Dysphonia; Dyspnoea; Pruritus; Rash; Throat irritation	FLU3~GLAXOSMITHKLINE BIOLOGICALS~Aflla281aa~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0358760	09/29/2009	SC	18.0	18		F	09/19/2009	Pt lost vision, felt dizzy, then passed out.  Became alert gain within 5 seconds, but tearful.									Y	09/19/2009	09/19/2009	0	None	OTH	PVT	Unknown	No	Unknown	same~Meningococcal (no brand name)~UN~0.00~Patient		1						1	Blindness; Dizziness; Loss of consciousness; Tearfulness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358761	09/29/2009	TN	65.0	65		F	09/29/2009	Patient was vaccinated in the left arm. FLUVIRIN and PNEUMOVAX given - 18 1/2 inches apart. There was no reaction at time of vaccination. The same day midnight patient developed pain, swelling. Next day she went to a clinic and got oral prednisone which did not help and patient was admitted to hospital on 9/28/09 suspecting possible phlebitis. IV antibiotic steroid was administered.   10/12/09 Hospital Records and Discharge Summary received service dates 9/28/09 to 9/29/09. Assessment: Left arm cellulitis, hypertension. Presents with left arm pain, redness and swelling. Pain radiates to neck. Admitted to hospital because of left arm cellulitis. Blood pressure uncontrolled on admission.   10/12/09 ICD-9 Codes: 999.39 Infection following oth infusion injection transfusion or vacc, 682.3 Cellulitis of arm, E879.8 Abn React-Procedure NEC, 401.9 Hypertension NOS, 414.9 Coronary atherosclerosis of native coronary vessel, V45.82 Percutaneous translum corn angioplasty status, V15.82 History of tobacco use.					Y	1			U	09/26/2009	09/27/2009	1	Unknown. LABS and DIAGNOSTICS: Blood cultures (-). CHEM - K 3.1 mmol/L (L) CL 108 mmol/L (H) Glucose 110 mg/dL (H) BUN 23 mg/dL (H) GFR 53 (L). Lymph 51.3% (H).	OTH	OTH	Unknown	None	None.  Hypertension. Coronary artery disease. PCI.			1						1	Pain; Swelling; Cellulitis; Condition aggravated; Hypertension; Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97849P1~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0632Y~2~IM~UN~PNEUMO (PNEUMOVAX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~~UNK~UN~LA~PNEUMO (PNEUMOVAX)~2	USA	Hospitalisation	Influenza
0358765	09/29/2009	AZ	11.0	11		U		11:00 am spoke with mom said pt got FLUMIST on 9-16-09. Pt has been c/o stomach pain, ache arms, headache, runny nose no fever no diarrhea. Mom's concern pt has flu? some symptoms. Mom would also like to know if its due to the FLUMIST. 9/16/09 - Notify parent. It could be a minor reaction. Since the vaccine is a live, weakened virus - it can cause minor symptoms resembling the flu, not the actual flu. If questions remain - I can answer questions. Please initiate VAERS report. 12:00 p.m. spoke with mom inform her it could be a minor reaction from FLUMIST per Dr. Inform mom, if pt's symptoms worsen or Pt gets fever to call us back to schedule app. Mom verbally understood and agree.										09/16/2009	09/19/2009	3		UNK	UNK						1						1	Abdominal pain upper; Headache; Immunisation reaction; Influenza; Pain in extremity; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500709P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0358766	09/29/2009	PA	21.0	21		M	09/18/2009	Patient lost consciousness after injection. Revived after use of ammonia inhalant-soon. Denies injury or any problem.									Y	09/18/2009	09/18/2009	0		OTH	PUB	None	None	None			1						1	Loss of consciousness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97845P1~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358768	09/29/2009	NY	40.0	40		F		2200 - 9-15. 9-15-09 - Presented to E.D. with pain, swelling, redness @ injection site into L supraclavicular region of neck. Also complaining of chest tightness and shortness of breath. BENADRYL and MOTRIN given in E.D. Flu vaccine given 9-14.				Y					Y	09/14/2009	09/15/2009	1		PUB	PVT	None	None				1						1	Chest discomfort; Dyspnoea; Erythema; Injection site erythema; Injection site pain; Injection site swelling; Local swelling; Neck pain	FLU3~SANOFI PASTEUR~U323AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358769	09/29/2009	IL	66.0	66		M	09/23/2009	Patient Complained of Pain in injection site, shooting up to neck 24 hrs after injection. Told to put ice on area and take Ibuprofen Followed up 48ho later and they said they felt better.									Y	09/12/2009	09/13/2009	1		OTH	PVT	N/A	N/A	N/A			1						1	Injection site pain; Neck pain; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1124X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358770	09/29/2009	IL	15.0	15		F	09/23/2009	Guideline stated that child should be given preservative free flu vaccine and pharmacy define child as anyone who is under 18 yrs, so FLUVIRIN which has preservative should not be given to the patient.  No adverse reaction per father also, had sister at Dr's office related to incidence.										09/21/2009			None	OTH	PVT						1						1	Inappropriate schedule of drug administration; No adverse event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358771	09/29/2009	TN	24.0	24		F	09/23/2009	Nausea/vomiting.									Y	09/16/2009	09/17/2009	1	None	OTH	PVT		None	None known			1						1	Nausea; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358773	09/29/2009	CA	72.0	72		M	09/21/2009	After giving the flu shot, the pt started bleeding.  After a few moments, I rechecked for bleeding and noticed that the area where I injected had become hard and formed a nodule.  I monitored the patient and after he said he felt fine I told him to go his PCP.  See attachment: After giving the flu shot in the L deltoid to the patient around 12:00 pm, he started bleeding.  I wiped it up with a cotton ball and placed a band-aid over it.  I then proceeded to give him PNEUMOVAX on the R deltoid.  I re-checked the patient's L deltoid to see if it was bleeding.  It was no longer bleeding, but the area where I injected the vaccine was now hard and developing a nodule.  I instructed the pt to stay in the pharmacy waiting room and to alert me if he was feeling adverse effects like dizziness, rash, difficulty breathing etc.  After fifteen minutes, I re-checked the L deltoid and the area still felt hard, yet no more bleeding.  The patient stated that he felt fine and did not feel any different.  I told him to go see his primary care provider so his doctor could inspect the area.  Pt seemed reluctant to go, but I continued to tell him the importance of seeing his doctor.				Y					U	09/21/2009	09/21/2009	0		OTH	PVT						1						1	Injection site haemorrhage; Injection site induration; Injection site nodule	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~978466P1~2~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0627Y~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358775	09/29/2009	MO	72.0	72		M	09/14/2009	Macular rash on injection arm (3) - 2 upper arm. 1 at elbow - rash appeared 24 -48 hrs after injection.										09/02/2009	09/04/2009	2	None	OTH	PVT		None	None			1						1	Injection site rash; Rash macular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358776	09/29/2009	RI	66.0	66		F	09/24/2009	Arm Pain Muscle Aches. Diarrhea Headache									Y	09/16/2009	09/16/2009	0		PVT	UNK		None	None			1						1	Diarrhoea; Headache; Myalgia; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLAZ79AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0358777	09/29/2009	GA	52.0	52		M	09/24/2009	Vaccine administered 9/16/09 at 12:45 pm.  Patient noticed slight swelling of upper lip that evening.  It got progressively worse.  He sought medical attention the following day.  Patient was prescribed PREDNISONE + BENADRYL.   Patient back to normal at this time.				Y					Y	09/16/2009	09/16/2009	0	None	OTH	PVT	None	None	None			1						1	Lip swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0358779	09/29/2009	MA	67.0	67		F	09/21/2009	Vaccinated at 10. At 12 developed runny nose, sneezing, difficulty breathing, gagging, runny eyes, fever and headache. Symptoms resolved except the headache in 24 hours. PCP notified.									Y	09/19/2009	09/19/2009	0		PUB	UNK		None	Chronic bronchitis-treated with inhalers			1						1	Dyspnoea; Headache; Lacrimation increased; Pyrexia; Retching; Rhinorrhoea; Sneezing	FLU3~SANOFI PASTEUR~U3188AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358780	09/29/2009	MA	3.0	3		F	09/24/2009	Noticed flesh colored rash 9-23-9 in groin on forehead & behind ears. + itch Strep cx-									Y	09/21/2009	09/23/2009	2	Strep Cx -	PVT	PUB	Zyrtec	None	Allergic rhinitis			1						1	Culture negative; Pruritus; Rash; Streptococcal identification test negative	FLU3~SANOFI PASTEUR~U3188AA~4~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB351CA~2~IM~LL~HEP A (HAVRIX)~1	USA		Influenza
0358785	09/29/2009	NY	40.0	40		F	09/29/2009	Itching and vomitting.  Received BENADRYL, PEPCID & Solu-Medrol in the Emergency Dept of the hospital. Severe vomiting, itching all over.				Y					U	09/21/2009	09/21/2009	0	Emp. not recovered yet	UNK	UNK	unknown	None reported	None			1						1	Pruritus; Pruritus generalised; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA449BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0358786	09/29/2009	NY	46.0	46		F	09/29/2009	Itching of limbs and back.  Benadryl IM administered in the Emergency Dept of Coney Island Hospital				Y					Y	09/24/2009	09/24/2009	0		PUB	PUB	unknown	unknown	unknown			1						1	Pruritus; Dyspnoea; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA449BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA449BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Emergency room visit	Influenza
0358787	09/29/2009	ME	12.0	12		F	09/29/2009	patient recieved vaccines as listed, then 2 hours later, had a seizure at school that consisted of staring into space, no tonic-clonic activity.  Does have an underlying seizure disorder, but hadn't had seizures in 2 years.  Was given rectal diastat- transported to ER for somnolence and monitoring.  Had valproic acid level checked - level 53 (normal 50-100) and had increased dose.  Discharged around 4 hours later stable and fully recovered 10/9/09 Received medical records from date 9/23/09 DC DX: Seizure.  Presenting symptoms: Parent stated pt was at school after receiving 4 vaccines in the morning had a staring episode where she was unresponsive. Parent states no seizures in 2 years. Pt c/o feeling tired in ER. Exam WNL.				Y					Y	09/23/2009	09/23/2009	0	valproic acid level 53 (nl 50-100) 10/9/09 Received medical records from date 9/23/09 Diagnostics/Labs: TSH .18(L), valproic acid level WNL.	UNK	UNK	ergocalciferol 50000unit cap, levoxyl 137mcg tablet, prevacid 30mg, trileptal 150mg, depakote 125mg, sertraline 50mg, clonidine 0.1mg, hydrocortisone 5mg	none	seizure disorder,VACTERL syndrome, congenital hydrocephalus, VP shunt, hypothyroidism; adrenal insufficiency 10/9/09 Received medical records from date 9/23/09  PMH: VACTERL syndrome. Congenital hydrocephalus, VP shunt, seizure disorder, adrenal insufficiency			1						1	Blood test normal; Convulsion; Staring	FLU3~SANOFI PASTEUR~u3176da~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0605y~1~IM~LL~HEP A (VAQTA)~1|MNQ~SANOFI PASTEUR~u3062aa~1~IM~RL~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~uf451ba~1~IM~RL~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0358788	09/29/2009	KY	62.0	62		F	09/29/2009	Pt. reports that she became violently ill with nausea/vomiting approx. 6 hours after influenza injection.  She went to the ER 1 hour after becoming ill and was given IV hydration and nausea medications.  She reports that she shook all over, as with a fever, but had no thermometer.				Y					Y	09/25/2009	09/25/2009	0	Pt. reports following labs:  CBC, Hemogram w/diff?/ complete metabolic panel, blood and urine cultures.  Pt also reports reading on her papers Tertiary diagnosis and Viral Syndrome.	PUB	PVT	Alpurinol, Insulin (Apidra and N), Diovan for B/P	None Known	Pt. reports allergies to:  Statin drugs, Iodine, Floxins and an ointment (can't remember name of it).  Patient has diabetes			1						1	Blood culture; Blood test; Culture urine; Differential white blood cell count; Full blood count; Malaise; Metabolic function test; Nausea; Tremor; Vomiting	FLU3~SANOFI PASTEUR~U3186AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358790	09/29/2009	CA	5.0	5		M	09/29/2009	FEVER 101.0 HIGHEST, TAKEN BY PARENTS, ORALY. FEVER INCREASES AT NIGHT. SLIGHT COUGH.				Y					U	09/25/2009	09/26/2009	1		PVT	PVT						1						1	Cough; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500709P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0358791	09/29/2009	NC	20.0	18		F	09/29/2009	Ten minutes after receiving the vaccine,  she developed a pruritic urticarial rash.  She took Benadry 25mg by mouth and symptions resolved.  When she awakened the next morning the rash and itching had recurred and she had swelling of the eyelids and a sensation of trouble breathing.  On exam she had a widespread urticarial rash.  Her throat was normal and her lungs were clear.  Her O2 saturation was 98% and vital signs were normal.  After a PO dose of Benadryl 25mg,  her symptoms resolved within 10 minutes.  She was observed for about an hour, then discharged with a Prednisone 10 mg,  6 day taper(60,50,40,30,20,10)  At a follow-up call several hours later she was feeling fine.									Y	09/28/2009				PVT	PVT		Seasonal allergies?				1						1	Dyspnoea; Eyelid oedema; Rash pruritic; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA282AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0358792	09/29/2009	WY	51.0	51		M	09/29/2009	Patient received flu vaccine and the next day developed papular rash to hands, legs, across  trunk.  Very pruretic. Was treated with diphenhydramine 50mg by mouth with no relief.  Next day developed spread over entire body.  Given two IM dexamethasone shots that day.  Elected not to give dexamethasone dose pack as patient HIV +, did not want to lessen immunity any further.									Y	09/15/2009	09/16/2009	1	None	MIL	MIL	Gabapentin 600mg tid, lamotrigine 25mg tid, omeprazole 20mg bid, promethazine 25mg 1/2 tablet bid prn headache, psyllium sugar free oral powder 2 tsp prn constipation, quetiapine 100mg qhs, trazodone 100mg qhs, MVI with minerals qd.	None	Allergies: Bactrim, Prozac, Silvadene cream, PCN, Haldol, Antabuse.  Medical Conditions: Alcohol dependence, polysubstance abuse, GERD, HIV, Hep C, Bipolar disorder.			1						1	Rash generalised; Rash papular; Rash pruritic	FLU3~CSL LIMITED~07649111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358794	09/29/2009	AL	49.0	49		F	09/29/2009	Received shot Friday night, Sat. OK, Sunday very tired, SUnday night, fever reaching 101.9 for several hours, body aches, chills. Fever broke during the night. Monday a little tired. A four iinch diameter red area on shot site.									Y	09/25/2009	09/27/2009	2		PUB	UNK		none	none			1						1	Chills; Fatigue; Injection site erythema; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA476AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0358796	09/29/2009	TX	39.0	39		F	09/29/2009	Developed hives to extremities and tightness to throat.  Treated at Emergency Room.				Y					Y	09/28/2009	09/28/2009	0		UNK	UNK						1						1	Throat tightness; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA476AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0358798	09/29/2009	OR	50.0	50		F	09/28/2009	2 hrs after vaccine: red edematous conjunctivae with arthragias, sweats, fever 100.5, fatigue,laryngitis, rhinnorhea. Improved in less than 24 hours. Treated with ibuprofen, benadry and 40 mg prednisone.									Y	09/28/2009	09/28/2009	0	none	PVT	PVT		none.				1						1	Arthralgia; Conjunctival hyperaemia; Conjunctival oedema; Fatigue; Hyperhidrosis; Laryngitis; Pyrexia; Rhinorrhoea	FLU3~CSL LIMITED~07949111A~UNK~~~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358799	09/29/2009	TX	51.0	51		F	09/29/2009	One day post flu vax, experienced temps 100.0 - 100.3 F nightly, extreme fatigue, muscular aching w/ burning sensation.  Has continued thru today.									Y	09/18/2009	09/19/2009	1	N/A	PUB	UNK	Synthroid; Norvasc; Glucophage, Januvia, Prilosec	Chronic: hypothyroidism; fibromyalgia; hypertension                           Acute:  none	Fibromyalgia (she is most concerned as it is neuro/musc.); Hypothyroidism; Asthma & seasonal allergies; Hypertension			1						1	Body temperature increased; Burning sensation; Fatigue; Myalgia	FLU3~SANOFI PASTEUR~U3201AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358800	09/29/2009	WI	37.0	37		M	09/29/2009	Heartburn and dyspnea				Y					Y	09/29/2009	09/29/2009	0		UNK	PVT	none	No	None			1						1	Dyspepsia; Dyspnoea	FLUX~SANOFI PASTEUR~V3167EA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0358801	09/29/2009	TX	68.0	68		F	09/29/2009	Very high fever, confusion, delirium, unable to recognize family, unable to walk on her own. She was taken to the ER for evaluation.  Then she was given Acetaminophen for the fever and labs were drawn.				Y					Y	09/21/2009	09/22/2009	1	All lab work was normal	UNK	PVT	None noted	None noted	None noted			1						1	Confusional state; Delirium; Gait disturbance; Laboratory test normal; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97845P1~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0358803	09/29/2009	MN	30.0	30		U	09/29/2009	Dizziness and confusion.  Four days later the skin around the injection site started sloughing.  There was no discoloration of the skin anywhere, nor any drainage.  The circumference was the size of a pen cap. The top to layers of skin came right off when I rubbed it.  The area around the site was unaffected.  The nurse didn't contaminate the needle and properly cleansed the injection site with alcohol.									N	09/25/2009	09/25/2009	0		UNK	UNK	None	None	None	Redness, hotness, swelling (with sterile technique)~Influenza (Seasonal) (no brand name)~UN~27.00~In Sibling1		1						1	Confusional state; Dizziness; Injection site exfoliation	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0358804	09/29/2009	CA	45.0	45		F	09/29/2009	Shot was given on Wednesday late afternoon or early evening.  By following morning I had a severely sore scratchy throat, painful sinus pressure, headache, dizziness, and extreme fatigue.  I slept most of the day Thursday, Friday, Saturday and Sunday. By late afternoon on Monday I began to feel some what better.									Y	09/23/2009	09/24/2009	1		UNK	UNK		none	seasonal allergies			1						1	Dizziness; Fatigue; Headache; Hypersomnia; Oropharyngeal pain; Sinus headache; Throat irritation	FLUX~UNKNOWN MANUFACTURER~319BAD? or BAI?~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0358806	09/29/2009	CA	9.0	9		F	09/29/2009	Patient received shot late afternoon or early evening on Wednesday.  She began to run a fever the following morning.  Her fever was 102 degrees from Thursday morning (24th) until Friday evening (25th).  She was felt achey, tired, and had a sore throat.  She began to feel much better by Sunday morning.									Y	09/23/2009	09/24/2009	1	none	UNK	UNK		none	none			1						1	Fatigue; Oropharyngeal pain; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~319BAD or BAI?~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0358810	09/29/2009	OR	17.0	17		F	09/29/2009	Non noted.  Adult flu vaccine given, ALFLURIA for over 18ys.									Y	09/14/2009			None	PVT	PVT		Fainting post vaccination	None			1						1	Inappropriate schedule of drug administration	FLU3~CSL LIMITED~05749111A~1~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358813	09/29/2009	MD	51.0	52		F	09/24/2009	Pt was given flu shot in L delt. said she was fine to leave on her own.  She went to the front desk to check out and apparently became faint- she hit her head on the wall-(I did not witness this event)-911 was called Pt was taken to ER. She vomited.				Y						09/24/2009	09/24/2009	0		PVT	OTH	AMITRIPTYLINE; PROTONIX; PHENERGAN; EVISTA; MIACALCIN NOSE SPRAY		NKDA-Wat loss-N/V			1						1	Dizziness; Head injury; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA460AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0358815	09/29/2009	OR	79.0	78		F	09/29/2009	Dizziness-First experienced PM after received seasonal flu shot about 10 AM 9/26/09-Dizziness has increased since then-ER visit in PM 9/28/09.  9/29/09 2:30 PM Pt reports resolved.				Y					Y	09/26/2009	09/26/2009	0		OTH	PUB	LISINOPRIL	None	Hypertension			1						1	Dizziness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P2A~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0358816	09/29/2009	NY	57.0	57		F	09/29/2009	severe leg muscle pain x 5 days severe headache and fatigue x 2 days swelling the size of a half dollar at injection site - red, hot - painful.									Y	09/17/2009	09/17/2009	0		PVT	PVT		None	None			1						1	Fatigue; Headache; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Myalgia	FLU3~SANOFI PASTEUR~U31676CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358819	09/29/2009	FL	49.0	49		F	09/28/2009	Body rash all over and itching. SOLU-MEDROL 250 mg IM X 1 on 9/28/09, BENADRYL 50 mg IM x 1 on 9/28/09.									Y	09/25/2009	09/26/2009	1		PUB	PVT	SYNTHROID 25 mg PO qd; PREMARIN .625 mg	No	No			1						1	Pruritus generalised; Rash generalised	FLU3~SANOFI PASTEUR~3207AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358820	09/29/2009	NM	75.0	75		M	09/29/2009	Patient experienced excruciating pain in arm several hours after PNEUMOVAX administration.  Patient still has some soreness and has been using ALEVE; EXCEDRIN; ice and a heating pad.									Y	09/17/2009	09/17/2009	0		OTH	PVT	Unknown	None	Unknown			1						1	Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0024Y~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358821	09/29/2009	MO	36.0	36		F	09/29/2009	No symptoms. Pregnant woman was given FLUVIRIN instead of AFLURIA.									Y	09/23/2009				OTH	OTH		No illness	Pregnant			1						1	Drug exposure during pregnancy; Wrong drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358822	09/29/2009	NM	69.0	69		F	09/29/2009	Patient experienced excruciating pain in arm several hours after PNEUMOVAX administration. Patient still has some soreness and has been using ALEVE, EXCEDRIN, ice and a heating pad.									Y	09/17/2009	09/17/2009	0		OTH	PVT	Unknown	None	Shoulder surgery			1						1	Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0024Y~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358824	09/29/2009	IA	85.0	85		U		Patient reported feeling lightheaded after FLUVIRIN injection. After 10minutes she felt better and needed to leave. We called her @ 9am the next morning and she said she was back to normal after eating dinner.									Y	09/28/2009	09/28/2009	0		OTH	PUB			heart surgery (told after she had rxn)			1						1	Dizziness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848P1A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358825	09/29/2009	FL	32.0	32		F	09/22/2009	Nausea & vomiting 2 days after injection-Recovered by 3rd day.									Y	09/19/2009	09/21/2009	2		UNK	PUB	Vicodin/Zoloft					1						1	Nausea; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97843P2~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358826	09/29/2009	FL	56.0	56		F	09/18/2009	Fever, chills, felt out of it, headache.									Y	09/13/2009	09/13/2009	0	N/A	PUB	PVT	Aciphex, Lipitor, Forteo, Alprazolam	None	Chol, GERD. Osteoporosis, Anxiety	yes~Influenza (Seasonal) (no brand name)~UN~32.00~Patient		1						1	Chills; Feeling abnormal; Headache; Pyrexia	FLU3~SANOFI PASTEUR~U3204AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358827	09/29/2009	TX	48.0	48		F	09/16/2009	Pt described burning sensation following shot. Returned to pharmacy after 10 min. had tingling & shooting pains down arm into hand. She did not want to visit dr. Ice applied and instructed to take OTC pain relievers.									U	09/16/2009	09/16/2009	0		OTH	OTH	Unknown	None reported	None reported			1						1	Burning sensation; Pain; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P2~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358828	09/29/2009	TX	48.0	48		F		Swelling, nausea, soreness, headaches.									U	09/21/2009	09/21/2009	0		OTH	PUB		None	Rheumatoid arthritis			1						1	Headache; Nausea; Pain; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P1~4~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1125X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358829	09/29/2009	FL	53.0	53		M	09/22/2009	Malaise 1 day after nausea/vomiting 2 days after some vomiting but able to eat 3 days after.									U	09/19/2009	09/20/2009	1		UNK	PUB	MS Contin/Lisinipril, Metformin/Reglan/Difluan					1						1	Decreased appetite; Malaise; Nausea; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97843P2~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358830	09/29/2009	VA	66.0	66		F	09/11/2009	I have received flu shots for years and never had the severe reaction as of 9/10/09. That night I awoke to chills and severe shaking, body soreness and flu like symptoms.  The shaking lasted for 1/2 hour.  No energy the following day and body soreness.									Y	09/10/2009	09/10/2009	0		PVT	PUB		No				1						1	Asthenia; Chills; Influenza like illness; Pain; Tremor	FLU3~SANOFI PASTEUR~U3211AA~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358831	09/29/2009	NM	62.0	62		F	09/23/2009	Arm swollen & fever about 102, diarrhea. 5 days later symptoms subsided. Pt came in 1 1/2 weeks later to report symptoms.									Y	09/14/2009	09/15/2009	1		OTH	OTH						1						1	Diarrhoea; Oedema peripheral; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0627V~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358832	09/29/2009	MN	28.0	28		F	09/16/2009	Loss of consciousness after FLUVIRIN given, came around quickly, very pale and sweating, deep breaths, moved her to the floor, rested, got up, went to restroom to wash face, sat another 15 minutes.									Y	09/15/2009	09/15/2009	0		OTH	OTH	PROZAC	None	None known			1						1	Hyperhidrosis; Hyperventilation; Loss of consciousness; Pallor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358836	09/29/2009	OH	69.0	69		U		After receiving shot, patient experienced redness and swelling at injection site immediately.  She only reported allergies to penicillin or dye.  With further questioning she said she was allergic to latex.  We immediately had patient place a cold compress on the swelling.  She felt better within 20 minutes.  She was instructed to take BENADRYL OTC 25mg q6h if needed. A follow up call to patient was made 3 hours later.  She said the arm felt fine but fir a small bump.  The Pharmacist wore latex gloves and the patient was allergic to latex.  The VAER may have been from the latex gloves and not from the flu-shot.									Y	09/24/2009	09/24/2009	0	None	OTH	PUB		None	None			1						1	Immediate post-injection reaction; Injection site erythema; Injection site nodule; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358837	09/29/2009	NY	58.0	58		F	09/23/2009	Morning after getting FLUZONE, developed fever, sore throat, congestion, body aches, dizziness.									U	09/15/2009	09/16/2009	1		OTH	PVT	PREVACID; SINGULAIR; HCTZ; SIMVASTATIN; PAXIL; MACROBID; vitamins	No	No			1						1	Dizziness; Oropharyngeal pain; Pain; Pyrexia; Respiratory tract congestion	FLU3~SANOFI PASTEUR~U3199AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358838	09/29/2009	AL	51.0	51		M	09/25/2009	Fasiculations around injection site started 30 minutes after injection.									U	09/17/2009	09/17/2009	0	None	OTH	PVT	LIPITOR; VITAMIN C; multivitamin	None	Allergic to sulfa; elevated cholesterol			1						1	Injection site reaction; Muscle contractions involuntary	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P1~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358839	09/29/2009	MO	53.0	53		M	09/25/2009	Vaccine given 9/24/09. Diarrhea started at 01:00, 9-25-09. Patient was nauseated, no vomiting. Felt weak and dizzy. Mouth and mucous membranes appear dry. Slight headache, SOB, hoarseness and wheezing. Pulse at 104. Also c/o fatigue. Refused treatment.									U	09/24/2009	09/25/2009	1	NI	OTH	PVT	None	None	None			1						1	Asthenia; Diarrhoea; Dizziness; Dry mouth; Dysphonia; Dyspnoea; Fatigue; Headache; Mucosal dryness; Nausea; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~0784901118~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0358840	09/29/2009	GA	71.0	71		F	09/24/2009	Administered inactivated vaccine (Influenza) L arm and Shingles vaccine R arm.  Rash noted after administration of Inactivated vaccine.  Rash noted to Rt arm & then Lt arm.  Benadryl 50mg IM given.  Pt axox3.  Blood Pres 160/80, Temp 98.2, Pulse 72, Res 18, Pulse Ox 98%.									Y	09/24/2009	09/24/2009	0	None	OTH	UNK	Benadryl given	Rash	None			1						1	Condition aggravated; Rash	FLU3~SANOFI PASTEUR~U3199AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~0748Y~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0358841	09/29/2009	NV	65.0	65		F	09/23/2009	Pain got worst on site of injection (right arm) at 9 pm (administered 2:30 pm 9/22/09), and by 12:00 AM patient cannot move her right arm anymore, went to ER and was given VICODIN. She was able to move her right arm a little bit this afternoon only 9/23/09 5:30pm), and still taking pain med. she will be seeing her MD in 48 hrs. Still in process, observing.				Y					U	09/22/2009	09/22/2009	0		OTH	PUB	PREVACID, SIMVASTATIN, LEVOXYL, CALCITONIN nasal spray	None	acid reflux, hypothyroidism, osteoporosis			1						1	Injected limb mobility decreased; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P1~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0632Y~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358842	09/29/2009	MO	80.0	80		F	09/24/2009	Pt received flu vaccine. I recommended she stay for 20 minutes after. While in waiting area her daughter approached me said she was having chest pains and feeling short of breath. I took her BP which was 185/77 then called Drs office who advised me to refer her the ER				Y					U	09/24/2009	09/24/2009	0	BP- 185/77	OTH	PUB	Warfarin for afib rest is unknown	None				1						1	Chest pain; Dyspnoea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~ID~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0358844	09/29/2009	CA	41.0	41		F	09/23/2009	Wheezing, swollen eyelids with discharge, chills, body aches.									Y	09/21/2009	09/22/2009	1		PVT	UNK		None	No			1						1	Chills; Eye discharge; Eyelid oedema; Pain; Wheezing	FLU3~SANOFI PASTEUR~U3194AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358846	09/29/2009	IA	89.0	89		F	09/15/2009	Patients injection site immediately bruised and became inflammed. The site was swollen and very hard. Pharmacist placed an ice pack on site until the swelling went away. Bruise remained.									Y	09/15/2009	09/15/2009	0		OTH	PUB		None				1						1	Immediate post-injection reaction; Injection site haematoma; Injection site induration; Injection site inflammation; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358847	09/29/2009	SC	23.0	23		F	09/29/2009	Swollen, extremely tender lymph node in R axillary region, with general aches to body. Node appears nickel to quarter size in diameter, raised area. Will see PCP tomorrow if ice and HYDROCORTISONE cream continues to not work.									N	09/24/2009	09/25/2009	1	None	PVT	OTH	None	None	None			1						1	Lymph node pain; Lymphadenopathy; Pain; Swelling	FLUX~UNKNOWN MANUFACTURER~~1~SC~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0358849	09/29/2009	NY	5.0	5		M	09/29/2009	Father states that after vaccination left arm became red and swollen.  He returned to clinic 4 days later, positive swelling & erythema of left arm.  Father states the redness and swelling had gotten a little better.  Advised warm compresses to the area 3 times a day.  Patient to return to clinic on 9/30/09 for PPD reading and F/U.										09/24/2009	09/25/2009	1		PUB	PUB		No	No			1						1	Injection site erythema; Injection site swelling	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B15DAA~UNK~UN~LA~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960333P~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358852	09/29/2009	DE	63.0	63		F	09/21/2009	Received phone call, 4 hours after vaccination, from patient complaining of swelling at site of injection of PNEUMOVAX. Patient has put ice on site of injection and taken BENADRYL. Patient calling Dr. in morning.									U	09/21/2009	09/21/2009	0		OTH	PUB	MIRAPEX; LANTUS; loratadine; JANUMET; ibuprofen; levothyroxine	None	Diabetes mellitus, hypercholesterolemia			1						1	Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1296X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358854	09/29/2009	TX	8.0	8		M	09/24/2009	Numbness of Rt upper extremities immediately. Later with weakness + numbness of right lower extremities last for about a day. Fever and vomiting the next afternoon. Rt UE numbness resolved 3 hrs later. Still a little weakness in Rt. leg.										09/21/2009	09/21/2009	0	Waiting on results	PVT	PVT			NKDA			1						1	Hypoaesthesia; Immediate post-injection reaction; Muscular weakness; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U3204AA~2~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358855	09/29/2009	MI	54.0	54		F	09/18/2009	(noted 48 hrs post inj) Itchy Rash originating at injection site, moving down left arm, around thorax (upper back, upper chest, down right arm).  Treated with PREDNISONE 72hrs later rash was mostly gone itch remained another 24 hrs.				Y					Y	09/11/2009	09/13/2009	2	None	PUB	PVT	ZOCOR 40mg; PLAVIX 81 mgASA; LOTREL 51.0; TOPROL 25mg; ALLEGRA 60mg BID	None	Penicillin; CAD; COPD; Rheumatic fever (age 8), 3 cardiac stent; tachycardia			1						1	Injection site pruritus; Injection site rash; Rash pruritic	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0358856	09/29/2009	TX	41.0	41		F	09/25/2009	A couple hours after taking flu shot she states her eyes suddenly turned red and matted up and started feeling a tightness in chest.  Waited until 3:30 pm to go to clinic to see dr.										09/23/2009	09/23/2009	0	A couple hours after taking flu shot she states her eyes suddenly turned red and matted up and started feeling a tightness in chest.  Waited until 3:30 pm to go to clinic to see dr.	OTH	PUB		No	No			1						1	Chest discomfort; Eye discharge; Ocular hyperaemia	FLU3~SANOFI PASTEUR~U3702AAA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358857	09/29/2009	NY	18.0	18		F	09/24/2009	The evening of the day dose was administered pt experienced sweats, fever, difficulty breathing and racing heart. She self treated with Benadryl and symptoms resolved that night.									Y	09/21/2009	09/21/2009	0		PVT	PVT	Prenatal Vitamins	None	Pregnancy			1						1	Dyspnoea; Hyperhidrosis; Palpitations; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA278AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0358859	09/29/2009	MI	17.0	17		F	09/24/2009	Gave patient the AFLURIA vaccine instead of FLUVIRIN.  No adverse events reported.									Y	09/24/2009				UNK	PVT	Unknown	None	None known			1						1	No adverse event; Wrong drug administered	FLU3~CSL LIMITED~05849111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358860	09/29/2009	VA	9.0	9		M	09/14/2009	5 to 7 minutes after giving pt immunization, he fainted and hit head on tile floor. Pt felt dizzy. He sat down, drank water, and put ice on forehead. After 15 minutes he was fine.									Y	09/14/2009	09/14/2009	0		OTH	PVT	clonidine	None	Unknown			1						1	Dizziness; Head injury; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358861	09/29/2009	CA	56.0	56		M	09/23/2009	Unable to lift arms and legs. Pain in hands, arms, legs, shoulders, hips.				Y					N	11/30/2008	12/15/2008	15	None yet (There looking towards arthritus types)	OTH	OTH						1						1	Arthralgia; Movement disorder; Musculoskeletal pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0358862	09/29/2009	IL	70.0	70		M	09/21/2009	Pt got vaccine 9/10 (Thurs). Went to ER following Tues. Had pain (extreme) in upper shoulder, and felt some pain in chest. Thought it might be heart attack but everything ok. Concluded due to flu shot. Stated pain was extreme.				Y					Y	09/10/2009	09/10/2009	0		UNK	OTH						1						1	Chest pain; Musculoskeletal pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0358865	09/29/2009	MO	39.0	39		F	09/25/2009	Face became very red/hot: temp of 99.7.  Felt bad/fatigued.  Nauseated, no vomiting.  Had 2 diarrhea stools and abd cramping.  Felt better am 9/25/09-Then abd cramping and sweating started at 0830 9-25-09.  Also was lightheaded/weak.  Sent home.									U	09/23/2009	09/24/2009	1	No information	OTH	PVT	HYDROCODONE-PRN MELOXICAME-PRN	None	Environmental Allergies			1						1	Abdominal pain; Asthenia; Body temperature increased; Diarrhoea; Dizziness; Erythema; Fatigue; Feeling abnormal; Hyperhidrosis; Nausea; Skin warm	FLU3~CSL LIMITED~078491118~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358867	09/29/2009	MA				M	09/24/2009	Vaccine at 2pm developed runny nose, sneezing, trouble breathing, vomiting, red eyes and headache, symptoms resolved in 24 hours. PCP called. Mother had identical reaction.									Y	09/19/2009	09/19/2009	0	N/A	PUB	UNK		None	Chronic Seizure condition			1						1	Dyspnoea; Headache; Ocular hyperaemia; Rhinorrhoea; Sneezing; Vomiting	FLU3~SANOFI PASTEUR~U3188AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358872	09/29/2009	RI	19.0	19		F	09/24/2009	Pt felt jittery, dizzy, shakey and vomited 1 hour post vaccine. Developed itchy throat, itchy skin, erythema and blotching bilat. arms.  Diaphoretic. No resp. Sxs.  Injection site tender warm and edematous.  Pt had also increased her dose of VYVANCE from 30 to 50mg at 10:30 same morning.									Y	09/23/2009	09/23/2009	0		PVT	PVT	PATANOL OPHT; YASMIN; VYVANCE; FLONASE		Hazelnuts; Nutmeg; EES/BIAXIN/ZITHROMAX; ADVIL; TYLENOL			1						1	Dizziness; Erythema; Feeling jittery; Hyperhidrosis; Injection site oedema; Injection site pain; Injection site warmth; Pruritus; Rash macular; Throat irritation; Tremor; Vomiting	FLU3~CSL LIMITED~05649111a~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358874	09/29/2009	TX	32.0	32		F	09/29/2009	32 y/o female developed SOB & chest tightness onset 12 days following receipt SPV, AVA 2, & inactivated influenza vaccines given 9/10/2009.  Pt first noted mild difficulty getting deep breath and tightness in chest on 9/22 which worsened by 9/23 accompanied by feelings of anxiousness due to difficulty breathing; symptoms not related to exertion or position; no coughing; wheezing or actual chest pain.  Pt was well prior to & day of vaccinations; denied antecedent viral illness, exposure to sick contacts, inhalants, recent travel; no cardiac, asthma. psychological smoking history; no prior vaccine-related reactions.  She is instructor with adult students in classroom setting.  PMHx significant for LTBI s/p completion 4 month course RIFAMPIN in early Aug 2009; pt had taken 2 doses of MEFLOQUIN (9/14 & 9/21) malaria prophy in preparation for scheduled deployment planned in early Oct.  She was medically evaluated in military ED 9/23/2009.  PE was reported as tachypneic respiratory exam otherwise benign, BP 147/83, HR 100, Temp 96.9, O2 set 100%; pt was felt to be low risk for pulmonary embolism per XX; phosphorous level noted low & treated with neutrophos; also given ATIVAN 0.5mg for anxiety; symptoms improved prior to d/c; final impression; doubtful deployment.  On 9/24 pt reported symptoms improved but not completely resolved, no new symptoms.  Cardiac panel, ESR, CRP-hs wnl 9//24.  Over phone f/u 9/28, pt says she saw her own private physician that AM with normal baseline spirometry in office and was advised to use inhaler prn symptoms - no opportunity to use thus far. On 9/28/2009 pt also saw MTF OCC Med physician who thought she had possible idiosyncratic reaction to MEFLOQUINE and recommended she remain off medication and use DOXY for malaria prophy.  Diagnosis: dyspnea, hypophosphatemia, idiosyncratic reaction to drug.  Symptoms: dyspnea, chest tightness.				Y					Y	09/10/2009	09/21/2009	11	9/23/2009: CBC; CMP; TSH; PT/PTT/INR, D-DIMER, HCG, CXR, EKG-unremarkable/negative except hypophosphatemia. 9/24/2009 at 1343 cardiac panel, ESR, CRP wnl.	MIL	MIL	Mefloquine 250mg taken 9/14 & 9/21/2009					1						1	Adverse drug reaction; Anxiety; Blood thyroid stimulating hormone; C-reactive protein normal; Cardiac enzymes normal; Chest X-ray; Chest discomfort; Dyspnoea; Electrocardiogram; Full blood count; Hypophosphataemia; International normalised ratio; Laboratory test; Metabolic function test; No reaction on previous exposure to drug; Prothrombin time; Red blood cell sedimentation rate normal; Tachypnoea	ANTH~EMERGENT BIOSOLUTIONS~FAV190~2~UN~UN~ANTHRAX (BIOTHRAX)~1|FLU3~SANOFI PASTEUR~U3176AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|SMALL~EMERGENT BIOSOLUTIONS~BAH~UNK~ID~UN~SMALLPOX (ACAM2000)~1	USA	Emergency room visit	Influenza
0358257	09/30/2009	IL	59.0	59		F	09/30/2009	Patient experienced unspecified muscle pain after vaccine administration (exact time frame unknown, however, presumably shortly after vaccination).  Per comments section of ADR report, patient went on ibuprofen 800mg for several days with no relief.  Further treatment, if any, unknown.				Y					U	09/18/2009	09/22/2009	4	N/A	MIL	MIL	N/A	N/A	Allergies: penicillin - itching; birth defects and medical conditions N/A			1						2	Arthralgia; Injection site swelling; Myalgia; Myalgia	FLU3~CSL LIMITED~07049111a~UNK~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1|FLU3~CSL LIMITED~07049111A~UNK~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~2	USA	Emergency room visit	Influenza
0358652	09/30/2009	LA	6.0	6		F	09/28/2009	Initial report received on 18 September 2009 from a consumer who is a physician. A 6 year old female patient with no reported medical conditions experienced an adverse event 2 days after receiving FLUZONE (lot number U3204AA) intramuscularly in the left deltoid on 09 September 2009. On 11 September 2009 the patient developed petechiae and bruising throughout the body. She was admitted to the hospital on 12 September 2009 and was diagnosed with idiopathic thrombocytopenic purpura. Platelet count was initially 3,000 and then was 37,000 (dates not provided). Treatment included IVIG (Intravenous Immunoglobulin). The patient was discharged on 15 September 2009. The patient was reported as doing better. No further information was provided. List of Documents held by Sender: none.  11/30/09 Medical records and discharge summary received for DOS 9/13-9/15. Final DX:  Immune thrombocytopenic  purpura Presented with petechiae on arms, trunk and neck x 4days IVIG.  Petechiae decreased.					Y	3			N	09/09/2009	09/11/2009	2	Platelet count was initially 3,000 and then was 37,000 (dates not provided).labs & Diags:  Platelets 3 (L), ABS NEUTR 17.54 (h), ABS LYMPH 0.78 (L), ABS MONO 1.17 (L)	UNK	UNK	Daytrana		Patient has no reported medical conditions. Concomitant therapy included Daytrana.		200903974	1						2	Blood product transfusion; Idiopathic thrombocytopenic purpura; Injection site swelling; Platelet count decreased; Blood product transfusion; Contusion; Idiopathic thrombocytopenic purpura; Petechiae; Platelet count decreased	FLU3~SANOFI PASTEUR~U3204AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U3204A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0358807	09/30/2009	MA	54.0	54		F	09/30/2009	12 hrs after vaccine felt like she got  hit by a bus difficulty sitting ot lying down due to discomfort. Ankle, thigh, back felt achy, nauseated, weird feeling in center of chest.									Y	09/24/2009	09/24/2009	0		PUB	PVT	None	None	Seasonakl allergies, MSG			1						1	Discomfort; Feeling abnormal; Nausea; Pain	FLU3~CSL LIMITED~07849111A~7+~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358877	09/30/2009	MD	27.0	27		F	09/30/2009	In less than 12 hours of receiving the flu shot my arm  was swollen, red , and warm to touch. It was extremely painful to move the arm and shoulder where the shot was given. By the next day i started having chills and trouble breathing. Once my rescue inhaler did not help the breathing i decided to go to the hospital. There i recevied breathing treatments by the respiratory technician and was given IV medicine for my shoulder. I was diagnosis with a allergic reaction to the flu shot and cellulitis in my right shoulder were the shot was given.				Y					Y	09/25/2009	09/25/2009	0		PUB	UNK	Depakote, Seasonique	none				1						1	Cellulitis; Chills; Dyspnoea; Erythema; Hypersensitivity; Injected limb mobility decreased; Oedema peripheral; Pain in extremity; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua4x2ba~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0358878	09/30/2009	NH	37.0	37		F	09/30/2009	SEVER GASTROINTESTINAL UPSET, PAIN IN ENTIRE BODY, SWOLLEN THROAT, INABILITY TO FOCUS, PAIN AT INJECTION SITE AND PAIN DOWN ARM TO FINGERS. MUSCLE PAIN, BONE PAIN, JOINT PAIN, HEADACHE, DIFFICULTY SWALLOWING,									U	09/29/2009	09/29/2009	0	NONE	PUB	UNK	YAZ BIRTH CONTROL PILLS, LEVOTHYROXIN .150 MG	NONE	NONE	SAME AS ABOVE, AT EVERY FLU VACCINATION~ ()~NULL~~In Patient		1						1	Arthralgia; Bone pain; Dysphagia; Gastrointestinal disorder; Headache; Injection site pain; Myalgia; Pain; Pain in extremity; Pharyngeal oedema; Vision blurred	FLUX~SANOFI PASTEUR~u32113aa~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0358880	09/30/2009	KY	33.0	33		F	09/30/2009	Received Flu Shot (Seasonal- Afluria PF 2009-2010- not 2009 H1N1)in upper left arm.  Moderate pain at the time of injection. Within 1-2 hours onset of SEVERE arm pain- about an 8 on a 1-10 scale (minor localized swelling, no redness) and my range of motion was limited to about 5% of normal. Pain increased throughout the evening and night.  Approximately 40 hours after vaccine, range of motion has improved to about 50%, and pain is rated at about a 4 depending on what position my arm is in.  Treated at home with tylenol and ice at injection site. Please note, if relevant, that I am 17 weeks pregnant. I've had flu and other IM vaccines in the past with no adverse reactions...even while pregnant.									U	09/28/2009	09/28/2009	0		UNK	PVT	Other medications I am currently taking- Zyrtec- 24 hr 1xday. Generic daily (non-prenatal) vitamin 1xday. 12hr generic Sudafed 1xday in AM.	Almost completely recovered from viral bronchitis- onset two weeks prior to vaccination.	Genetic Liver Disease- Cholesterol Ester Storage Disease.  Severe allergies- trees, pollen, grass, animals. PDA at birth.	None with any other injection~ ()~NULL~~In Patient		1						1	Injected limb mobility decreased; No reaction on previous exposure to drug; Oedema peripheral; Pain in extremity	FLU3~CSL LIMITED~33332-0009-01~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358882	09/30/2009	CA	66.0	66		F	09/30/2009	4-15-09 noticed area red, swollen, warm in am.  Saw doc, gave her TYLENOL.  By 11 AM continued to spread.  Saw doc again.  Diagnosed as cellulitis.  Gave 1 g ROCEPHIN IM, 4 mg DECADRON IM, 80 mg DEPONEDROL IM and PO BENADRYL 50 mg q6n as needed.  By 9-17-09 pt had completely recovered.				Y					Y	09/13/2009	09/15/2009	2		OTH	OTH						1						1	Cellulitis; Erythema; Oedema peripheral; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2A~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1125X~2~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358885	09/30/2009	NY	42.0	42		F	09/30/2009	Difficulty breathing, wheezing, hives, afebrile.  Treatment BENADRYL P.O.									Y	09/28/2009	09/28/2009	0	None	PUB	OTH	Malaria prophylaxis.	None	None			1						1	Dyspnoea; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~SPU3253DA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358886	09/30/2009	OK	27.0	27		M	09/29/2009	Developed Myalgias / cough 24Sept09, day after flu mist and 2 days after HUMIRA injection. He was treated with TAMIFLU.									Y	09/23/2009	09/24/2009	1		MIL	OTH	HUMIRA	mild URI	Psoriasis - taking HUMIRA			1						1	Cough; Myalgia; Influenza	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500679P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0358891	09/30/2009	IN	27.0	27		F	09/30/2009	Approximately 15 minutes after vaccine administration, individual experienced a rash & hives on both arms, neck, & chest.  No history of allergy to eggs or Flu vaccine ingredients.  Individual is an RN with known history of Penicillin(rash/hives)& shellfish (hives/anaphylatic shock hospitalization) allergies.  She carries Benadryl & EpiPen with her at all times, so she took some Benadryl and continued to her home.  Did not seek medical treatment.  Symptoms subsided within 30-45 minutes according to her report.  She left a phone message for writer on Infection Control Office phone the following morning reporting the adverse reaction.									Y	09/29/2009	09/29/2009	0	NA-Individual didn't seek medical care	PUB	UNK	Alese (Birth Control)	Rhinitis & sinus drainage due to allergies per individual's statement	Allergy to Penicillin (Rash/hives)as an infant and Shellfish (Hives/Anaphylactic shock)with hospitalization at age 12 or 13	None~ ()~NULL~~In Patient|None~ ()~NULL~~In Sibling1|None~ ()~NULL~~In Sibling2		1						1	Rash generalised; Urticaria	FLU3~SANOFI PASTEUR~U3195AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358895	09/30/2009	OR	17.0	17		M	09/29/2009	Gave pt AFLURIA instead of FLUZONE.									N	09/17/2009	09/17/2009	0	No	PVT	UNK		No	No			1						1	Wrong drug administered	FLU3~CSL LIMITED~05749111A~1~UN~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358896	09/30/2009	WA	13.0			M	09/29/2009	Gave pt AFLURIA instead of FLUZONE.									N				No / X-ray foot.	PVT	OTH		No	No			1						1	Wrong drug administered	FLU3~CSL LIMITED~05789111A~1~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358897	09/30/2009	OR	2.0	2	.3	M	09/29/2009	Patient received 0.25 of AFLURIA instead of the ped dose.									Y	09/10/2009			None	PVT	PVT	Sodium Fluoride	None	None			1						1	Incorrect dose administered	FLU3~CSL LIMITED~05749111A~UNK~IM~LL~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358898	09/30/2009	OR	14.0	14		F	09/29/2009	Patient received 0.5 ml of AFLURIA instead of FLUZONE.									Y	09/24/2009			None	PVT	PVT	CLEVCIN 1% swab.	None	None			1						1	Wrong drug administered	FLU3~CSL LIMITED~05749111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358899	09/30/2009	OR	2.0	2	.6	M	09/28/2009	AFLURIA 0.25 given to pt opposed to pediatric do o vaccine.									Y	09/18/2009			No	PVT	UNK		None	None			1						1	Inappropriate schedule of drug administration	FLU3~CSL LIMITED~05749111A~UNK~IM~RL~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358900	09/30/2009	OR	8.0	8		M	09/28/2009	AFLURIA .5 given to Pt as apposed to pediatric vaccine.									Y	09/18/2009			None	PVT	UNK	None	None	None			1						1	Incorrect dose administered	FLU3~CSL LIMITED~AF05749111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358901	09/30/2009	OR	10.0	10		M	09/28/2009	AFLURIA .5 given to pt as opposed to pediatric vaccine.									Y	09/18/2009			No	PVT	UNK	None	None	Heart Murmur; systolic.			1						1		FLU3~CSL LIMITED~05749111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358902	09/30/2009	MO	16.0	16		F	09/30/2009	The 16 yo child described muscle twitching all over following vaccination (7pm same day). The mother took her to Hospital ER. They ran tests, which showed that nothing was wrong. The twitching was not witnessed in ER. The next day child experienced flu-like  symptoms and stayed home from school. The day after 9-30-9 felt fine & returned to school, has not complained of any further muscle twitching.				Y					Y	09/28/2009	09/28/2009	0	Urine test at Hospital	OTH	OTH	CITALOPRAM 20  mg, LUTERA birth control	No	Mild asthma, allergies to Sulfa drugs and black berries			1						1	Activities of daily living impaired; Influenza like illness; Muscle twitching; Urine analysis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0358903	09/30/2009	NH	53.0	53		F	09/30/2009	Less than 24 hours following vaccine employee got a fine red rash on chest, neck, arms and trunk. Not raised, not itchy, - completely resolved within 24 hours.									Y	09/23/2009	09/24/2009	1		PUB	PVT		None	None			1						1	Rash erythematous	FLU3~SANOFI PASTEUR~U3259FA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358904	09/30/2009	NY	17.0			F	09/10/2009	Erythema at vaccine site - increased pain & heat.									N					PVT	PVT	None	None	None			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U3199AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358905	09/30/2009	OR	18.0	18		F	09/25/2009	Achy, weak, dizzy, chest pain, headache, shaky, twitching, fever 100.4 - 101.6, 4 mo old whiplash pain renewed as if fresh, severe arm pain, chilled, swelling of right arm for 2 days. Has triggered OCD & depression episode as of 9-25-09.									Y	09/18/2009	09/19/2009	1		OTH	PVT	Celexa, Amitriptiline	None	OCD, depression, Ibs, tactile sense disfunction	screaming~DTP (no brand name)~1~0.00~Patient|~ ()~1~0.00~Sibling		1						1	Asthenia; Chest pain; Chills; Condition aggravated; Depression; Dizziness; Headache; Muscle twitching; Neck pain; Obsessive-compulsive disorder; Oedema peripheral; Pain; Pain in extremity; Pyrexia; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~66521-0112-10~4~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~00006-4739-00~2~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358906	09/30/2009	IL	66.0	66		M	09/24/2009	Fever, headache, nausea, congestion, pain, swelling, redness travelling down inside left arm (fevered).  Treated at ER and given BACTRIM DS on 9/24/09.				Y					N	09/22/2009	09/22/2009	0		OTH	PVT	TERAZOSIN; METOPROLOL; TARTRATE; ASA; FENOFIBRATE; VIAGRA.	None	Hypertension; Hypercholesterolemia.			1						1	Erythema; Headache; Nausea; Pain; Pyrexia; Respiratory tract congestion; Skin warm; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0632Y~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358907	09/30/2009	MO	37.0	37		F	09/25/2009	Headache/fatigue/weakness/nausea.  Also felt very hot/sweaty, vomited AM of 9-25-09 (X2).  Adb. cramping/ no diarrhea.  Unable to keep fluids down.  Decreased voiding.  Pulse - 100.  Appears dehydrated/lips dry.  Feels bad chilling sent to urgent care.				Y					U	09/24/2009	09/24/2009	0	NI	OTH	PVT	None/PREMARIN.	None	CODEINE; PENICILLIN.			1						1	Abdominal pain; Asthenia; Dehydration; Dysuria; Fatigue; Feeling abnormal; Feeling cold; Feeling hot; Headache; Hyperhidrosis; Lip dry; Nausea; Urine output decreased; Vomiting	FLU3~CSL LIMITED~078491118~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0358908	09/30/2009	MN	7.0	7		F	09/24/2009	Red spots, hot, painful, red, swollen.				Y					Y	09/01/2009	09/03/2009	2	Treated with antibiotic.	PVT	PVT	None	None	Neuroblastoma			1						1	Erythema; Pain; Skin warm; Swelling	FLU3~SANOFI PASTEUR~U3200AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0235X~1~IM~LL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358910	09/30/2009	CO	78.0	78		M	09/24/2009	Developed redness and swelling 24 hours after administration that rapidly spread. Exam was concerning for cellulitis. Started on KEFLEX.									U	09/21/2009	09/22/2009	1		PVT	PVT	None	None	None			1						1	Cellulitis; Erythema; Swelling	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B208AA~1~UN~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U3201AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF5695AA~1~UN~LL~HIB (ACTHIB)~1	USA		Influenza
0358911	09/30/2009	MD	52.0			M	09/26/2009	Hot and cold sweats - loss of sleep - irritability.				Y					N					PUB	UNK			Bipolar	~Influenza (Seasonal) (no brand name)~1~0.00~Patient		1						1	Cold sweat; Hyperhidrosis; Insomnia; Irritability	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0358912	09/30/2009	TN	46.0	46		U		Dizziness, chest pain, HPB/Tachycardia.				Y						09/15/2009	09/15/2009	0	See attached report.	MIL	MIL	Prilosec/Nasacort AQ, Claritin	None	Seasonal Allergies			1						1	Anxiety; Chest pain; Discomfort; Dizziness; Hypertension; Insomnia; Nervousness; Pain; Sensory disturbance; Tachycardia; Tobacco user	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0358913	09/30/2009	OH	3.0	3		M	09/30/2009	Crying, non-stop for hours after vaccination.									Y	01/06/2009	01/06/2009	0	None	PVT	PUB	Albuterol; Folic acid; Clonidine	None	ADHD; CP; fragile X; PSNT; Anomalous A/V excitation			1						1	Crying	FLU3~SANOFI PASTEUR~U2839AA~4~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358914	09/30/2009	FL	54.0	54		F	09/30/2009	09/25/09 10:22AM returned client's call. She received a Flu vacc. 09/23/09, Wed., and on 09/24/09 she has pain,redness, and swelling LDT, injection site, with bumps and itching. She called her MD and was instructed to take OTC Benadryl. The pain,redness, and itching are better today.									Y	09/23/2009	09/24/2009	1	None	UNK	UNK	None Known.	None per client.	Allergy to Toradol. H/O colon cancer with colon resection. Last chemo and radiation tx. 2002. H/O heart damage after treatments per client.			1						1	Injection site erythema; Injection site pain; Injection site pruritus; Injection site rash; Injection site swelling	FLU3~SANOFI PASTEUR~U3214AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358915	09/30/2009	MA	8.0	8		F	09/30/2009	Child received vaccine on 9/29/09; less than 24 hours later developed increasing redness, 8x8cm area warm to touch and itchy. Treated with Keflex for 7 days; to use po Benadryl for itch				Y					U	09/28/2009	09/29/2009	1	None	PVT	PUB	Proair as needed		Asthma			1						1	Erythema; Pruritus; Skin warm	FLU3~SANOFI PASTEUR~U3188AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358917	09/30/2009	MI	17.0	17		F	09/30/2009	dizziness, flushing, anxiety, difficulty concentrating				Y						09/29/2009	09/30/2009	1		PVT	PUB	buspar, ortho tricyclen	none	none			1						1	Anxiety; Disturbance in attention; Dizziness; Flushing	FLU3~SANOFI PASTEUR~u3209aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358918	09/30/2009	AL	1.5	1	.5	F	09/30/2009	Child reportly became combative, agitated, screaming, biting, jerking and wheezing approximately 6 hours following influenza vaccination. No fever, no localized reation. After calling MD, Mother gave Benedryl and breathing treatments throughout night. Went to daycare following morning.									Y	09/29/2009	09/29/2009	0	None	PUB	PUB	Singulair daily, Albuterol, Previcid as needed.	None	Asthma and Acid Reflux			1						1	Abnormal behaviour; Aggression; Agitation; Dyskinesia; Screaming; Wheezing	FLU3~SANOFI PASTEUR~U3191AA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358919	09/30/2009	WA	36.0	37		M	09/30/2009	Minor localized reaction(swelling) to Inluenza and pneumococcal in L deltoid diagnosed after physician evaluation									Y	09/28/2009	09/28/2009	0		MIL	MIL			Diabetes			1						1	Injection site swelling	FLU3~CSL LIMITED~01479211A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~1162X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358923	09/30/2009					U	09/28/2009	Initial report received on 17 September 2009 from a health care professional. A cluster of two patients with no reported medical history experienced oculorespiratory syndrome after receiving FLUZONE SV (lot number not reported), on an unspecified date over the last two to three days. The syndrome consisted of very red and swollen eyes, upper respiratory tract symptoms (shortness of breath, chest pain, cough, congestion). Recovery status was not reported. No further information was provided. List of Documents held by Sender: none.				Y					U				not reported	UNK	UNK			not reported		200903977	1						1	Chest pain; Cough; Dyspnoea; Eye swelling; Ocular hyperaemia; Oculorespiratory syndrome; Respiratory tract congestion	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358937	09/30/2009					M	09/29/2009	Information has been received from a consumer concerning one of her acquaintance, a male patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not reported). The patient received ZOSTAVAX (Merck) and an unspecified flu vaccine together and had to be hospitalized (hospital name, address, phone number unspecified) for a while (number of days unspecified) because his whole body was messed up (not further specified). It was unknown if there were lab studies performed. The outcome of the patient was not reported. No further information is available.				Y	Y				U				Unknown	OTH	OTH			Unknown		WAES0909USA03706	1						1	Adverse event	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~UN~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Hospitalisation	Influenza
0358942	09/30/2009	TX	74.0	74		U		-Redness and swollen at site of injection (below injection site).									U	09/28/2009	09/29/2009	1		OTH	PUB		None				1						1	Erythema; Injection site erythema; Injection site swelling; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA259AA~2~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0358943	09/30/2009	NY	42.0	42		F	09/30/2009	Sensation of heat, itching in throat, cough - To Ed - SOLUMEDROL IV, PEPCID, IV fluids//PROVENTIL -BENADRYL and Prednisone at home.				Y					Y	09/18/2009	09/18/2009	0		PVT	UNK		None	Asthma			1						1	Cough; Feeling hot; Throat irritation	FLU3~SANOFI PASTEUR~U3174EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358944	09/30/2009	NY	32.0	32		F	09/30/2009	Went to ED c/o body felt on fire after receiving vaccine - C/o chest pain at 1 hour after arriving in ED - mild swelling (L) deltoid - No redness/no rash - No acute distress - No SOB - Rec'd XANAX and TYLENOL				Y					Y	09/24/2009	09/24/2009	0		PVT	UNK	BCP		Pyloric ulcer; Anxiety			1						1	Chest pain; Feeling hot; Injection site swelling	FLU3~SANOFI PASTEUR~U3253CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358945	09/30/2009	NY				M	09/30/2009	SOB, tingling, itching in throat - rash - BENADRYL, SOLUMEDROL.				Y					Y					UNK	UNK			NKA - No meds			1						1	Dyspnoea; Paraesthesia; Rash; Throat irritation	FLU3~SANOFI PASTEUR~U3253CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358946	09/30/2009	TN	36.0	36		F	09/30/2009	Fever 102.1; chills, aches, c/o (R) arm hurting.				Y						09/29/2009	09/29/2009	0		PUB	UNK	FeSO4 BID	None	Chronic myelogenous leukemia			1						1	Chills; Pain; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U3195AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1076X~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358947	09/30/2009	NY	35.0	35		F		B/L erythematous sclera with discharge (+) pharyngeal infections with erythema - no exudate. symptoms developed 6 hours after vaccine - treated with BENADRYL.									U	09/30/2009	09/30/2009	0	None	PUB	OTH	SINGULAIR	None	Environmental allergies - NKA	None~ ()~~0.00~Patient|None~ ()~~0.00~Sibling		1						1	Eye discharge; Pharyngeal erythema; Pharyngitis; Scleral hyperaemia; Conjunctivitis; Cough; Oropharyngeal pain; Physical examination	FLU3~SANOFI PASTEUR~U3176CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U3176CA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0358948	09/30/2009	IA	67.0	67		F	09/30/2009	Patient experienced numbness in arm vaccine was given in.  Numb feeling also went into upper back and right side of face.  Numbness was gone when patient left store.									Y	09/29/2009	09/29/2009	0		UNK	UNK		No	No			1						1	Hypoaesthesia; Hypoaesthesia facial; Injection site anaesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~06274~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0358949	09/30/2009	OH	78.0	78		F	09/30/2009	L arm red, swollen and hot from left shoulder to left elbow the entire circumference and back to left scapular.  Temp 98.2 sent to PCP.									Y	09/28/2009	09/29/2009	1	None	UNK	UNK	PPV, Merck, Lot# 1296X, Route/site right deltoid 0.5 ml IM; No previous doses 14 06.					1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3213AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358950	09/30/2009	DC	41.0	41		F	09/30/2009	Left clavicular (supra) lymphadenopathy, fatigue myalgias.										09/28/2009	09/29/2009	1		PUB	UNK		None	Asthma; Seafood allergy.			1						1	Fatigue; Lymphadenopathy; Myalgia	FLU3~SANOFI PASTEUR~UT3172BA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358951	09/30/2009	CO	88.0	88		F	09/30/2009	Visual changes - trouble focusing, double vision.  Vision gets better when she closes 1 eye.  Started when she was walking to car after flu shot (9/28) - and continued for 3 days.									U	09/28/2009	09/28/2009	0		OTH	PUB	L-THYROXINE; DIURETIC.	Congestive heart failure.	None known.			1						1	Diplopia; Vision blurred	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846PZA~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358952	09/30/2009	PA	12.0	12		F	09/30/2009	20 minutes after receiving injections of HEP A, MENACTRA, ADACEL, & FLUMIST became pale, light headed, Loc.									Y	09/30/2009	09/30/2009	0		PVT	PVT	None	None	None			1						1	Dizziness; Loss of consciousness; Pallor	FLUN3~MEDIMMUNE VACCINES, INC.~500691P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~MERCK & CO. INC.~0604Y~1~IM~LA~HEP A (VAQTA)~1|MNQ~SANOFI PASTEUR~U2917AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~UF499BA~1~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0358953	09/30/2009	KY	12.0	12		F	09/29/2009	Pt fainted 20 min after injection of GARDASIL, FLUZONE and LA BICILLIN injections. Hit head. No LOC. No sequelae noted - Did well after TX.									Y	09/29/2009	09/29/2009	0	None	PVT	PUB		Strep				1						1	Head injury; Syncope	FLU3~SANOFI PASTEUR~U3185AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0672Y~2~UN~RA~HPV (GARDASIL)~1	USA		Influenza
0358954	09/30/2009	MN	1.03	1	.0	F	09/30/2009	Raised wheal inferior to site of VARIVAX vaccine left outer thigh. Ice applied, liquid BENADRYL (12%mg/5 ml) 2.5 ml given, monitored for 90 minutes on clinic.									Y	09/30/2009	09/30/2009	0		PUB	PUB						1						1	Injection site urticaria	FLU3~SANOFI PASTEUR~U3210AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB357CA~1~IM~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0554Y~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0847Y~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0358955	09/30/2009	WA	47.0	47		F	09/30/2009	Shoulder pain, ache + stiffness.  Some sharp pain when lifting.  For the last 2 weeks.				Y					N	09/13/2009	09/13/2009	0		MIL	OTH	MAXALT		Migraines			1						1	Musculoskeletal pain; Musculoskeletal stiffness; Pain	FLU3~SANOFI PASTEUR~U3185AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358959	09/30/2009	CO	4.0	4		M	09/30/2009	Right deltoid swollen, red, and warm to touch. Treatment - ice pack and NSAIDs.									U	09/28/2009	09/29/2009	1		PUB	UNK						1						1	Injection site erythema; Injection site swelling; Injection site warmth	DTAP~SANOFI PASTEUR~C3141AA~5~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U3189AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~D0039~4~SC~LL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0706Y~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0989Y~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0358960	09/30/2009	KY	35.0	35		F	09/24/2009	Influenza virus vaccine (FLUVIRIN) 2008-2009 formula expiration date 6/30/2009 given instead of 2009-2010 formula, vaccinated with influenza virus vaccine (FLUZONE) 2009-2010 formula after error discovered.									Y	09/22/2009				PVT	PVT		None	PCN;  LORTAB;  CIPRO;  PERCOCET			1						1	Unevaluable event; Wrong drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88910~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358961	09/30/2009	KY	58.0	58		F	09/24/2009	Influenza virus vaccine(FLUVIRIN) 2008-2009 formula expiration date 6/30/2009 given instead of 2009-2010 formula, vaccinated with influenza virus vaccine (FLUZONE) 2009-2010 formula after error discovered.									Y	09/18/2009				PVT	PVT		None				1						1	Expired drug administered; Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88910~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358962	09/30/2009	KS	13.0	13		F	09/20/2009	Influenza virus vaccine (FLUVIRIN) 2008-2009 formula expiration date 6/30/2009 given instead of 2009-2010 formula, vaccinated with influenza virus vaccine (FLUZONE) 2009-2010 formula after error discovered.									Y	09/15/2009				PVT	PVT		None				1						1	Expired drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88910~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358963	09/30/2009	KY	57.0	57		M	09/24/2009	Influenza virus vaccine (FLUVIRIN) 2008-2009 formula expiration date 6/30/2009 given instead of 2009-2010 formula, vaccinated with influenza virus vaccine (FLUZONE) 2009-2010 formula after error discovered.									Y	09/15/2009				PVT	PVT		None				1						1	Expired drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88910~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358964	09/30/2009	KY	54.0	54		F	09/24/2009	Influenza virus vaccine (FLUVIRIN) 2008-2009 formula expiration date 6/30/2009 given instead of 2009-2010 formula, vaccinated with influenza virus vaccine (FLUZONE) 2009-2010 formula after error discovered.									Y	09/14/2009				PVT	PVT		None				1						1	Expired drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88910~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358970	09/30/2009	MN	5.0	5		F	09/30/2009	Ten hours after administration, patient complained of abdominal pain.  This continued for the next 16 hours.  Twenty hours after administration, patient had chills, and within the hour started to get a fever.  Fever started at 99.1F and one hour later it was 103.6 F.  Motrin was administered to reduce fever.  Patient slept for several hours. Twenty eight hours after administration and continuing, patient has a low grade fever that is not being treated.									Y	09/28/2009	09/29/2009	1	No tests.	PVT	UNK	None.	None.	Allergic to amoxicillan.	None~ ()~NULL~~In Patient|None~ ()~NULL~~In Sibling1		1						1	Abdominal pain; Chills; Pyrexia	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~~5~IM~RL~DTAP + IPV (KINRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~6~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~UNKNOWN MANUFACTURER~~2~IM~LL~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~2~IM~RL~VARICELLA (NO BRAND NAME)~1	USA		Influenza
0358971	09/30/2009	NJ	64.0	64		M	09/30/2009	Had flu shot on Wed. 9/23/09 and on Thursday had muscle tighness in back and pain in shoulder and on Fri. the back pain was even worse.  Went to chiropracter on Mon. Improving with therapy by chiropracter									Y	09/23/2009	09/24/2009	1		PUB	PVT	None	None	None			1						1	Back pain; Muscle tightness	FLU3~SANOFI PASTEUR~U3184AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358972	09/30/2009	FL	73.0	73		F	09/30/2009	HIstory of Ocular burning and itching and drainage in past after flu vaccine- lasted 4-5 days. Recent flu vaccine resulted in similar symptoms within 24 hrs. Concern for possible occular respiratory syndrome associated with influenza vaccine									U	09/28/2009	09/29/2009	1	none	MIL	MIL	atenolol	none known		Occular burning and itching~Influenza (Seasonal) (no brand name)~NULL~58.00~In Patient		1						1	Burning sensation; Oculorespiratory syndrome; Pruritus	FLU3~CSL LIMITED~07249111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358977	09/30/2009	TX	38.0	38		F	09/30/2009	complained of pain to injection site followed by itching to arm and then a cough and tightness to throat				Y					Y	09/28/2009	09/28/2009	0		PUB	UNK						1						1	Cough; Injection site pain; Pruritus; Throat tightness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA476AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0358978	09/30/2009	MI	40.0	40		F	09/30/2009	Numbness and tingling in lower arms and hands bilaterally and in face.  Heaviness in chest (without tightness or wheezing).  Both occurred within minutes of receiving vaccine.  Extreme fatigue occurred later in the evening.  All symptoms were gone by the next morning.									Y	09/25/2009	09/25/2009	0	None.	PVT	PVT	Atenolol 50 mg 1 x day.  Birth Control Pills.	none.	NKDA.  Seasonal allergies.	Same symptoms last yr.~Influenza (Seasonal) (Fluzone)~NULL~39.00~In Patient		1						1	Chest discomfort; Fatigue; Hypoaesthesia; Hypoaesthesia facial; Paraesthesia	FLU3~SANOFI PASTEUR~U3189AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358979	09/30/2009	MI		55		F	09/30/2009	Pt felt pain w/inj.About 10 minutes later felt warm sensation from left jaw line, left arm and left torso. Pt given one Benadryl capsule. Sytems subsided with in a half hour. During that time pt. went from hot to cold,then normal feeling.									Y	09/30/2009	09/30/2009	0		PVT	PVT		none				1						1	Feeling hot; Feeling of body temperature change; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98441P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358982	09/30/2009	CA	47.0	48		F	09/30/2009	Received flu vaccine at approx 10:00 AM and then about 13:30 PM start to have cough, SOB, extreme weakness, Chills, Sore throat, hoarseness and puffy eyes. She stated no fever. She called me at approx 10:00 on 09/30/09 and said that she felt better and did not seed medical attention. she did have residual hoarseness, but other symptoms have resolved.									Y	09/29/2009	09/29/2009	0	NA	PVT	PVT	None	None	None			1						1	Asthenia; Chills; Cough; Dysphonia; Dyspnoea; Eye swelling; Oropharyngeal pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA257CA~3~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0358986	09/30/2009	AZ	30.0	30		F	09/30/2009	Patient states he awoke the morning after the shot with decreased appetite, weakness, lassitude, muscle aches and a feeling of cloudy headed.  His symptoms have slowly subsided over the course of the day except for the cloudy headed feeling, which he stated was still slightly present.  He was advised to take acetominophen for symptoms, but it is unknown if he did.									U	09/29/2009	09/30/2009	1	None	UNK	PVT	N/A	N/A	N/A	N/A~ ()~NULL~~In Patient		1						1	Asthenia; Decreased appetite; Fatigue; Feeling abnormal; Myalgia	FLU3~CSL LIMITED~07849111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358987	09/30/2009	TX		58		F	09/30/2009	Patient developed swollen tongue which formed ridges along the edge of the tongue.  She also described of swollen tongue. She did feel very warm and she sounded a bit muffled.  I checked her blood pressure and pulse which were low but normal to her.  Swelling did improved but then got worst and improved again.  She felt better when she left but still had some ridges not as define. I called her an hour later and she reported feeling better after taking some Benadryl.									Y	09/30/2009	09/30/2009	0	Had a flu shot 2007	UNK	PVT	Valtrex 1gm QD	N/A	N/A			1						1	Heart rate decreased; Hypotension; Skin warm; Swollen tongue	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA257AA~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0358988	09/30/2009	WI	43.0			U	09/30/2009	Patient called clinic today stating she has hives to face and feels this is from flu vaccine received 9/29/09 at clinic. Patient states she felt funny last night after vaccine received.Patient advised to use claritin.zyrtec during day and benadryl at night.Patient to see MD if increased problems.									U					PVT	PVT		none known				1						1	Feeling abnormal; Urticaria	FLU3~SANOFI PASTEUR~U3187AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358989	09/30/2009	TX	36.0	36		F	09/30/2009	Morning after vaccine administered, had swollen matted eye lid (right), swollen (right) upper and lower lips.  Vaccine administered shortly after 3pm, and symptions appeared the following day approximately at 3:30AM.  Treatment:  hot compress over eyes, then 6:30AM ice to lip areas.  RESOLVED									Y	09/29/2009	09/30/2009	1	None conducted	UNK	UNK	No routine medications.  Did take Benadryl 9-30-09 for insomnia and seasonal allergies, and took Tylenol 9-29-09 to prevent arm soreness at site of injection.	Well	Employee states none of the above			1						1	Eyelid oedema; Lip swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98438P1~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0358990	09/30/2009	TN	60.0	60		F	09/30/2009	Facial paralysis - Bell's Palsy, left; paresthesias within 48 hours of immunization followed by rapidly progressive facial motor weakness; treated with oral steroids and valacyclovir for 7 days beginning 3 days after immunization; partial resolution (~50%) of symptoms at post-vaccination day 15.				Y					U	09/15/2009	09/17/2009	2	None	UNK	PUB	Estrace	None	None			1						1	Facial palsy; Facial paresis	FLU3~CSL LIMITED~08049111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0358991	09/30/2009	CA	29.0	29		F	09/30/2009	Sudden onset of nausea, congestion in chest, and generalized weakness less than 24 hours after vaccine administration.  Tylenol given.				Y					U	09/29/2009	09/30/2009	1	N/A	PVT	PVT	None.	None.	Allergies to vicodin and bactrim - cramping.  PMHx of asthma.			1						1	Asthenia; Nausea; Upper respiratory tract congestion	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA468CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0358993	09/30/2009	CO	38.0	38		M	09/30/2009	Muscle aches, muscle pains, hand shakes, muscle tension, fatigue, weakness, started 9/16 continues to have fatigue, dizziness, lightheaded				Y					N	09/16/2009	09/17/2009	1	ck labs	UNK	UNK						1						1	Asthenia; Blood creatine phosphokinase; Dizziness; Fatigue; Musculoskeletal discomfort; Myalgia; Tremor	FLU3~SANOFI PASTEUR~U3214AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0358994	09/30/2009	TX	17.0	17		M	09/30/2009	Administered vaccine and got up to leave and within 3 minutes patient passed out.  Patient also, demonstrated tremors with eyes rolling back.  The patient's mother was there and is a physician's assistant.  The patient then snapped out of it and was talking to mom.  Patient tried to stand up after laying for a while and then passed out again..  911 was called and an ambulance took patient to hospital for observation.				Y					U	09/30/2009	09/30/2009	0	unknown	UNK	PVT	unknown	no	none			1						1	Gaze palsy; Loss of consciousness; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P2~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0358997	09/30/2009	CA	2.0	2	.4	F	09/30/2009	Pt was vaccinated 9/28/09 and pt developed redness, swelling and color at injection site 9/29/09. Today this leg is slightly more swollen.									U	09/28/2009	09/29/2009	1		UNK	UNK		URI	Seasonal allergies.  No known drug allergy.			1						1	Injection site discolouration; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U73A9EA~4~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0358998	09/30/2009	WA	26.0	26		F	09/29/2009	Area appears to be hard, firm & raised.  Reddish surrounding area.									U	09/28/2009	09/29/2009	1		OTH	UNK						1						1	Injection site erythema; Injection site induration; Injection site swelling	FLU3~CSL LIMITED~0594911A~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0358999	09/30/2009	WA	74.0	74		F	09/30/2009	Pt said approximately 2 hrs after vaccination, she broke out in hives around the torso area.  The next morning she was extremely tired and vomited.  Hives went away in approx. 2 days.  No rash or pain at site.  Pt reported this in passing on 9-25009 but she can't be absolutely sure it's due to the vaccine.  She said she gets vaccine every year and never had a problem. She said she just thought she'll mention it.  She said she's fine on 9-25-09 but thought she'll let me know.									Y	09/15/2009	09/15/2009	0	Spoke to pt again on 9-30-09, once again she's not sure it's due to the vaccine.  She said she does have a hx of hypertensive immune system and she would break out at different places spontaneously.	OTH	UNK			Pt said she has history of Hypertensive Immune System where she'll just breakout armpit, breasts, legs.  She said dr ran many tests and cannot determine cause.			1						1	Fatigue; Urticaria; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~9784611~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359000	09/30/2009	UT	50.0	50		F	09/30/2009	Pt started with rash at inner arm on elbow joint and behind knee on the day after she got the shot. Rash getting worse for 5 days after shot. She had taken BENADRYL for last 36 hours.									U	09/24/2009	09/25/2009	1		OTH	UNK	None	No	No			1						1	Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~H842P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359005	09/30/2009	IL	48.0	48		F	09/30/2009	The left upper arm was redness, tender indurated and warm 9/30/09. She has left arm pain. No neurological findings.									U	09/29/2009	09/30/2009	1		PUB	UNK	METTROMIN; GABAPENTIN; SIMVASTATIN;					1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site warmth; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97845P2~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~UNKNOWN MANUFACTURER~AHAVB326AA~1~UN~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0359006	09/30/2009	KY	23.0	23		F	09/29/2009	Influenza virus vaccine (FLUVIRIN) 2008 - 2009 formula expiration date 6/30/2009 given instead of 2009-2010 formula.  Vaccinated with influenza virus (FLUZONE) 2009-2010 formula after error discovered.									Y	09/18/2009			None	PVT	PVT	None	None	None			1						1	Expired drug administered; Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88910~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359007	09/30/2009	KY	49.0	50		M	09/29/2009	Influenza virus vaccine (FLUVIRIN) 2008-2009 formula expiration date 6/30/2009 given instead of 2009-2010 formula.  Vaccinated with influenza virus vaccine (FLUZONE) 2009-2010 formula after error discovered.									Y	09/22/2009			None	PVT	PVT	None	None	None			1						1	Expired drug administered; Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88910`~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359008	09/30/2009	KY	52.0	52		F	09/29/2009	Influenza virus vaccine (FLUVIRIN) 2008-2009 formula expiration 6/30/2009 given instead of 2009-2010 formula. Vaccinated with influenza virus vaccine (FLUZONE) 2009-2010 formula after error discovered.									Y	09/22/2009			Non	PVT	PVT	None	None	None			1						1	Expired drug administered; Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88910~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359009	09/30/2009	KY	19.0	19		M	09/29/2009	Influenza virus (FLUVIRIN) 2008-2009 formula expiration date 630/2009 given instead of 2009-2010 formula.  Vaccinated with influenza virus vaccine (FLUZONE) 2009-2010 formula after error discovered.									Y	09/18/2009			None	PVT	PVT	None	None	None			1						1	Unevaluable event; Wrong drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88910~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359010	09/30/2009	KY	23.0	23		F	09/28/2009	Influenza virus vaccine (FLUVRIN) 2008-2009 formula expiration date 6/30/2009 given instead of 2009-2010 formula.  Vaccinated with influenza virus vaccine(FLUZONE) 2009-2010 formula after error discovered.									Y	09/18/2009			None	PVT	PVT	None	None	penicillin			1						1	Expired drug administered; Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88910~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359012	09/30/2009	KY	51.0	51		M	09/27/2009	Influenza Virus Vaccine (FLUVRIN) 2008-2009 Formula Expiration Date 6/30/2009 Given Instead of 2009-2010 Formula, Vaccinated with Influenza Virus Vaccine (FLUZONE) 2009-2010 Formula After Error Discovered.									Y	09/18/2009			N/A	PVT	PVT	NA	None	Penicillin			1						1	Expired drug administered; Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88910~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359013	09/30/2009	AZ	3.0	3		F	09/30/2009	20 mins after inj. pt complained of headaches and leg pain. Fever began and arm turned purple/red and was swollen 3-4 inches long and 3 inches wide. Pt given TYLENOL and BENADRYL and today 9/30/09 arm is the same w/ head pain and leg pain.										09/28/2009				PVT	UNK	None	None	Asthma; ear infections			1						1	Headache; Injection site discolouration; Injection site erythema; Injection site swelling; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~UT3178CA~4~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359014	09/30/2009	IL	72.0	72		F	09/30/2009	Patient came in to pharmacy approximately 28 hours post vaccination, with a very swollen right arm, the arm was also red and warm to the touch. The swelling started around injection site and continued down the arm until halfway between the elbow & wrist. Patient could not fully extend arm at the swollen elbow. Patient stated her arm began to hurt & swell about 4 hours post vaccination. She did not contact upon her arrival at the pharmacy & contacted PCP exchange and pt. was told to proceed to ER. Pt was treated with steroids, antibiotic and pain medication. MD suspected allergic reaction or possible infection. Has only received 1 dose thus far & little to no improvement.				Y					N	09/28/2009	09/28/2009	0		OTH	PVT	Unknown	None	No known birth defects allergies-Codien & opiod analgesics. No known medical conditions			1						1	Erythema; Hypersensitivity; Injection site swelling; Joint range of motion decreased; Oedema peripheral; Pain in extremity; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98438P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0632Y~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0358700	10/01/2009	NY	41.0	41		F	10/01/2009	Received vaccine at about 8p.m. on 9/25/09 as was told it was mandatory. I am  an RN on the night shift 7p.m. -7a.m... Eyes became very red and felt dry......By 3 o'clock felt nauseaus and fainted. Vomited x2. Was noted to be in afib and hypotensive.Transfered from E.R. to ICU on cardizem drip..				Y	Y	1			Y	09/25/2009	09/26/2009	1	Labs wbc elevated, ekg, echo, CT of head and chest, Cardiac enzymes all done.	PVT	UNK		none	high cholesterol, allergic to ampicillin			1						2	Atrial fibrillation; Blood potassium decreased; Borrelia burgdorferi serology negative; Culture urine negative; Dizziness; Pregnancy test negative; Skin warm; Vomiting; White blood cell count increased; Atrial fibrillation; Cardiac enzymes; Computerised tomogram; Dry eye; Echocardiogram; Electrocardiogram; Hypotension; Intensive care; Nausea; Ocular hyperaemia; Syncope; Vomiting; White blood cell count increased	FLU3~CSL LIMITED~08249111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|FLU3~CSL LIMITED~08249111a~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~2	USA	Hospitalisation	Influenza
0358745	10/01/2009	FL	47.0	47		F	10/01/2009	9/16 @1200 flu shot recieved. 9/17 @0130 up balance off dizzy caused nausea with vomiting. Went back to bed up again @ 0500 same problem. Started antivert 12.5mg for next 48 hours, only helped nausea and vomiting. 9/19 to work balance off nausea continued no vomiting went home early could not do job. Called off sick 9/20 for same reason employee health nurse (Anesia) called message left. 9/21 Anesia called informed I needed to go to the ER. Test done cbc,cmf, mri brain(all wnl).V.S. all within normal. No cough, fever, sore throat,earache or trauma before of after vaccine. Consult with Nuerology done pt recommended for vestibular issues. 9/21 @1545 PT Eval done with considerable improvement. Up 9/22 same problems.PT eval 9/23 and treatment with considerable improvement again, but different instructions for next 48 hrs. Had to remain sitting up no stooping or looking up or down. Sent home from work after PT. 9/25 100% better released from PT. Off next few days did fine. Release to go back to work 9/28. Cut grass 9/28 after being released with no limitations. Up 9/29 with same issue of balance, dizziness, and nausea. Follow up with ENT 9/30 AND 10/1 vestibular treatment done with some relief of dizziness and nausea, balance still off. Instructed for next 48 hours to sleep upright and avoid stooping motions. This is where we stand 10/1				Y					N	09/16/2009	09/17/2009	1	MRI Brain- normal CBC- normal CMF- normal	UNK	UNK	levothyroxyine, valtrex, muti-vitamin. meclizine and pepcid only since 9/17	NONE	HYPOTHYROID, Allerigy- compazine			1						2	Dizziness; Balance disorder; Dizziness; Full blood count normal; Laboratory test normal; Nausea; Nuclear magnetic resonance imaging brain normal; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA470AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA470AA~1~SC~RA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Emergency room visit	Influenza
0358995	10/01/2009	FL	39.0	39		F	10/01/2009	Time of vaccine 13:00 9/28/2009. At 16:00 swelling of throat, nasopharnx, and chest tightness began.  Benedryl 50mg PO taken at 16:30, followed by another 25mg PO at 21:00.  9/29/2009 - 3am 25mg Benedryl PO, still swelling of throat, difficulty swallowing and chest soreness. Albuteral inhaler utilized, 11:00 25mg Benedryl PO, 19:00 50mg Benydryl PO. 9/30/2009 am relief of 90% of swelling, no chest tighness, Zyrtec PO at 18:00.									Y	09/27/2009	09/27/2009	0		UNK	UNK			none	Exact symptoms of this event~Influenza (Seasonal) (no brand name)~NULL~24.30~In Patient		1						1	Chest discomfort; Chest pain; Dysphagia; Pharyngeal oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359002	10/01/2009	WA	65.0	65		F	09/30/2009	Within 30 minutes of vaccination, pt developed itching, generalized erythema, and hives.  Provided pt with 2 DIPHENHYDRAMTINE 25 mg capsules and referred her to urgent care ctr.  Denied any difficulty breathing.  Pt was treated at emergency room and discharged the same day.				Y					Y	09/28/2009	09/28/2009	0		OTH	UNK		None	Garlic; CODEINE; MORPHINE; Sulfa.			1						1	Generalised erythema; Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359015	10/01/2009	NY	39.0	39		F	09/30/2009	Head feels heavy, throat tightness & feels dry. Benadryl 25 mg taken po by employee @ 11:05 AM.									Y	09/30/2009	09/30/2009	0		OTH	PVT	Multivitamins	None	None			1						1	Dry throat; Head discomfort; Throat tightness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960301P~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359017	10/01/2009	FL	53.0	53		F	09/30/2009	Point of injection swollen, red painful to the touch, hot/cold chills, headache, muscle aches, diarrhea, joint pain.										09/28/2009	09/28/2009	0		OTH	PUB		None				1						1	Arthralgia; Chills; Diarrhoea; Feeling of body temperature change; Headache; Injection site erythema; Injection site pain; Injection site swelling; Myalgia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97844P1~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359018	10/01/2009	GA	3.0	3		F	10/01/2009	Syncope/adverse reaction to flu vac. Pt passed out at daycare.									Y	09/18/2009	09/18/2009	0	Syncope	PVT	PVT	None	None	Allergic Rhinitis, Resp. infection, bronchitis			1						1	Loss of consciousness; Syncope; Vaccination complication	FLU3~SANOFI PASTEUR~U3200AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359025	10/01/2009	MI	56.0	56		F	10/01/2009	On 9/24/09 at approx. 9AM patient reported having SOB and wheezing at approximately 7PM on 9/23/09 while sitting in a parked vehicle. Symptoms subsided approximately 9:30PM the same evening without treatment. According to patient, he had a childhood history of Asthma thought to be caused by allergies. Pt. has history of difficulty breathing while smoking but has not smoked for 5 years. Patient opted not to seek treatment.									Y	09/23/2009	09/23/2009	0		PVT	PVT						1						1	Asthma; Dyspnoea; Wheezing	FLU3~SANOFI PASTEUR~43184AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359026	10/01/2009	MD	46.0	46		F	10/01/2009	Approx 20 mins after injection, the site began to sting, burn, and turn red. The burning and redness continued to occur. The next day my arm was very stiff from the shoulder to fingers. It continued this way for approx 48 hours. Benadryl was taken. When seen by my physican he prescribed Medrol Dosepak.				Y					Y	09/28/2009	09/28/2009	0		UNK	UNK	synthroid,nexium,kapidex,lopressor	GERD	GERD;hypothryoid. Allergies: PCN, cephlasporins,sulfa,codeine,morphine,dialudid,catgut,fentanyl,sublimaze,benzoin	redness at injection site~Influenza (Seasonal) (no brand name)~UN~44.00~Patient		1						1	Injection site erythema; Injection site pain; Musculoskeletal stiffness	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0359027	10/01/2009	NY	29.0	29		F	10/01/2009	Patient received the seasonal influenza vaccine on 9/28/09 7 pm and after 2 hours developed a erythematous itchy rash on face, chest, abdomen and arms and swollen upper lip with some numbness.  After 10 hours she to the ER and was given Solu-Medrol 60 mg IV and Benadryl 25 mg IV with Pepcid 20 mg IV piggyback.  She was discharged after about 2  hours on Allegra 60 mg bid. She has had seasonal influenza vaccines in the past without any reaction.				Y					Y	09/28/2009	09/28/2009	0	None	UNK	UNK	None	No	None			1						1	Hypoaesthesia; Lip swelling; No reaction on previous exposure to drug; Rash erythematous; Rash pruritic	FLU3~SANOFI PASTEUR~UT3175BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359029	10/01/2009	NE	68.0	68		F	10/01/2009	Right arm/injection site. Swelling noted from deltoid to slightly above elbow. Nickel and quarter sized raised areas with erythema. Arm is sore from Shoulder to elbow.									U	09/29/2009	09/30/2009	1		PVT	PVT	SIMVASTATIN, OMEPRAZOLE, LEXAPRO, ASACOL	NONE	ALL: SACCYCHOLINE. HEALTH HX: COLITIS, GERD, HPL, DEPRESSION			1						1	Injection site erythema; Injection site swelling; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA282AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1076X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359030	10/01/2009	GA	34.0	34		M	10/01/2009	10-15 minutes after injection, pt. felt weak, dizzy and about to pass out.  Went to plant nurse. B/P 80/50. pt was transported via nurse to ER.  Blood work done with UA. Started D51/2 NS with Kt. Pt. was released around 12 noon.  MD stated this was an allergic reaction to the flu shot. When speaking with plant nurse, Nurse stated pt had similar event about 2 weeks ago.				Y					Y	09/29/2009	09/29/2009	0	CBC, SMA7 and UA	UNK	UNK	None		NKA			1						1	Asthenia; Dizziness; Full blood count; Hypersensitivity; Laboratory test; Urine analysis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA265AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0359031	10/01/2009	OH	40.0	40		M	10/01/2009	Nine days after receiving flu vaccination I came down with severe muscle pain, fever, weakness in my joints, and partial numbness in my feet and hands with also some loss of movement and loss of strength. At one point I was unable to get up from a reclining or sitting position for about a day. After some blood tests and three visits to my physician the diagnosis of 'serum sickness' and Guillain Barre syndrome was given. I have begun to recover but I still residual pain in my muscles and loss of manual dexterity in my fingers. 10/23/09 Medical records received for dates 9/24/09 to 9/30/09. Pt presented to office on 9/24/09 c/o HA, muscle pain, dysphagia, dyspnea, fever, diarrhea after receiving flu vax. PE WNL. DX viremia. 9/26/09 Pt. presented with muscle pain x2-3days, fever, trouble walking up stairs due to pain, arm pain, shortness of breath. PE WNL. DX: myalgia, probably viral syndrome, does not look like GBS. 9/30/09 Pt presented with c/o loss of movement in legs, lost coordination, strength in legs and hands. DX: reaction serum. ICD9 codes: 999.5, 729.1, 790.8				Y					U	09/14/2009	09/23/2009	9	10/23/09 Medical records received for dates 9/24/09 to 9/30/09 Labs: West Nile, Lyme disease negative, platelets 130(L), WBC 3.5(L).	UNK	UNK		None	none 10/23/09 Medical records received for dates 9/24/09 to 9/30/09 PMH: mosquito bites			1						1	Asthenia; Blood test; Hypoaesthesia; Hypokinesia; Motor dysfunction; Myalgia; Pyrexia	FLUX~SANOFI PASTEUR~U3205CA~UNK~IJ~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0359032	10/01/2009	MA	45.0	45		M	09/30/2009	Severe malaise starting less than 1 hour after receiving vaccine. Possible syncope and altered mental status starting about 2 hours after receiving vaccine and lasting about 45 minutes.  10/06/09 Received hospital medical records for 9/24-9/26-2009. FINAL DX: allergy to flu shot vaccine; syncope w/LOC & altered mental status due to allergic reaction; pancytopenia c/w cirrhosis & interferon tx. Records reveal patient experienced malaise s/p flu vaccination, fell & was unresponsive at home w/lengthy recovery time.  Then developed achiness, HA, eye swelling, orthostatic BP.  Tx w/IVF, steroids.  Progressed well & d/c to home. ICD9 codes: 78009; 7802; 2841; 78009; E9496; 37992; 7242				Y	Y	2			Y	09/24/2009	09/24/2009	0	Urine drug screen (-) except Cannabinoids; Head CT and MRI (-)  LABS: EKG w/bradycardia & LVH.  CT brain  & EEG WNL.	PVT	PUB	OXYCODONE; NADOLOL; PRILOSEC; Peg interferon; Riboflavin; Amitriptyline	Hepatitis C; Pancytopenia; Lumbar disc disease	Hepatitis C; Pancytopenia; Lumbar disc disease; Depression; Anxiety; Insomnia; History of substance abuse 10/6/09 Medical records received w/PMH: alcoholic cirrhosis,  gallstone pancreatitis, s/p cholecystectomy, splenomegaly, cocaine induced MI, chronic LBP			1						1	Computerised tomogram normal; Drug screen positive; Malaise; Mental status changes; Nuclear magnetic resonance imaging normal	FLU3~SANOFI PASTEUR~U3188AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0359045	10/01/2009	AZ	88.0	88		M	09/30/2009	Information has been received from a physician concerning an 88 year old male with parkinson's disease and no known drug allergies who on 17-SEP-2009 was vaccinated IM into the right arm with a 0.5ml dose of PNEUMOVAX (lot# 662785/1124X), concomitantly with a dose of influenza virus vaccine (unspecified). Concomitant therapy included MIRAPEX, methimazole, docusate Na, carbidopa/levodopa, SENNA LAX and TYLENOL. The physician reported on 18-SEP-2009, the patient developed cellulitis. The patient's right arm was swollen and red. On 19-SEP-2009 he experienced severe diarrhea and fever. He was admitted in a hospital on 19-SEP-2009. He was treated with antibiotic and BENADRYL. He was released from the hospital on 21-SEP-2009. On unknown date, the patient recovered. A lot check has been initiated. Additional information has been requested.				Y	Y	2			Y	09/17/2009	09/18/2009	1	Unknown	OTH	OTH	TYLENOL; carbidopa (+) levodopa; docusate sodium; methimazole; MIRAPEX; senna	PARKINSON'S disease			WAES0909USA03997	1						1	Cellulitis; Diarrhoea; Erythema; Oedema peripheral; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1124X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0359046	10/01/2009	MO	43.0	43		F	10/01/2009	Patient recieved flu shot on 9/30/09 at approximately 1pm.  Approximately 30 mintues after recieving the shot the patient reported to the nurse that her arm felt cold and numb (like it was asleep).  The nurse inspected the arm and noted no redness, edema, ecchymosis or other abnormalities.  Patient was asked if she would like to be seen by a physician and she declined.  Patient was instructed to contact facility if symptoms worsened.  Patient was contacted on 10/1/09 for follow-up on symptoms and reported that the feeling in her arm has returned to normal and she is just a little sore at the injection site.									Y	09/30/2009	09/30/2009	0	None	UNK	UNK	Allegra D	None	None known			1						1	Feeling cold; Hypoaesthesia; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960312P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359047	10/01/2009	OH	46.0	46		F	10/01/2009	Pt. states that approximately 12 hours after receiving influenza vaccination, her eyes began to itch and her throat felt scratchy. States area around injection site is red and warm. States that today (10/01/09) she has a rash on her face and neck.  States her scalp feels itchy.  Eyes are swollen.  Has taken OTC Benadryl x3.  Has not contacted her physician or ED.  Denies ever having difficulty breathing.									N	09/28/2009	09/29/2009	1	None at this time	PUB	PVT		none noted	none noted			1						1	Eye pruritus; Eye swelling; Injection site erythema; Injection site warmth; Pruritus; Rash; Throat irritation	FLU3~SANOFI PASTEUR~U3207AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359048	10/01/2009	RI	34.0	34		F	10/01/2009	Broke out into hives, had trouble breathing, was pale.  Went down to Urgent Care in my building and had to get a breathing treatment, decadron shot and benadryl.  Was given a prescription for Medrol Dose Pack, The next day had to go back to Urgent carea for another shot of decadron because was still having trouble breathing. Gave my a differect prescription for predisone, Hydroxzine and Zantac.				Y					Y	09/29/2009	09/29/2009	0		PVT	UNK		none	allergic to sunflowers, latex,codeine,compazine			1						1	Dyspnoea; Pallor; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0359049	10/01/2009	CA	31.0	31		F	10/01/2009	Flu like symptoms after administration of flu mist lasted for about one week. Progressed to bronchopneumonia the following week, lasted for two weeks. Was given Avalox for treatment and followed up with pulmonary provider.				Y					Y	09/09/2009	09/12/2009	3	chest x-ray	MIL	MIL		none	nkda			1						1	Bronchopneumonia; Chest X-ray; Influenza like illness	FLUN3~MEDIMMUNE VACCINES, INC.~500695P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0359050	10/01/2009	OH	77.0	77		M	10/01/2009	Dry, red area at injection site-25x20 mm. Upper Respiratory Infection symptoms. Body aches. Vesicular reaction-told to keep clean and dry, contact personal physician for further evaluation if needed. Area appears to be healing. Clients symptoms have improved.									Y	09/25/2009	09/26/2009	1		PUB	PVT	Claritin, Captopril		Multiple allergies-environmental, Hypertension, History of Bronchitis and Upper Respiratory Infections			1						1	Injection site dryness; Injection site erythema; Pain; Rash vesicular; Upper respiratory tract infection	FLU3~SANOFI PASTEUR~U3167DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359054	10/01/2009	WI	46.0	46		M	10/01/2009	Approximately 12 hr after receiving vacinations, patient developed injection site soreness, erythema and induration in left arm where Pneumovax injection was given.  He also reported low grade fever, sore throat and malaise. By day 3, he reported feeling better and local reaction had improved some.									U	09/28/2009	09/29/2009	1		UNK	PVT	fluoxetine, Oxycontin, Viagra					1						1	Injection site erythema; Injection site induration; Injection site pain; Malaise; Oropharyngeal pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA28AA~UNK~ID~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0612Y~1~SC~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359056	10/01/2009	KS	31.0	31		F	10/01/2009	Erythema and induration approxiamtely 3 inches surrounding the site of injection. This began to appear with in a few hours of the vaccination. I few hives around the injection site. Severe generalized itching for approximately 3 days. Improved with benedryl and ranitidine.									Y	09/23/2009	09/23/2009	0	None	PVT	UNK	Albuterol, NuvaRing, Singulair, Claritin	None	Asthma-Moderate-Well controlled			1						1	Injection site erythema; Injection site induration; Injection site urticaria; Pruritus generalised	FLU3~SANOFI PASTEUR~Unknown~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359062	10/01/2009	MA				F	10/01/2009	This case was reported by a healthcare professional and described the occurrence of left sided facial numbness in an elderly female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 24 September 2009 the subject received unspecified dose of FLULAVAL (details unknown). On 25 September 2009, 1 day after vaccination with FLULAVAL, the subject experienced numbness on left side of face and cheek and slurred speech. The healthcare professional considered the events were disabling. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.				Y				Y	N	09/24/2009	09/25/2009	1	UNK	PUB	OTH		Unknown	Concomitant medications and medical history were unknown. The subject had received a different brand of influenza vaccine (not FLUARIX or FLULAVAL) last year with no adverse effects. The subject had not experienced adverse events following previous vaccinations.		A0809654A	1						1	Dysarthria; Hypoaesthesia facial	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Disabling	Influenza
0359063	10/01/2009	FL	90.0	90		F	10/01/2009	This case was reported by a healthcare professional and described the occurrence of stroke in a 90-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included high cholesterol and osteoporosis. Concurrent medications included Fish oil, OSCAL D, EFFEXOR, MAXZIDE, Vitamin E, ARICEPT, CELEBREX, NORVASC, ZOCOR, B12, LIDODERM, Potassium, Vitamin D, BONIVA, Mylanta, Duoneb, TRAMADOL, CATAPRES and Tylenol. On 25 September 2009 the subject received 1st dose of FLUARIX (0.5 ml, unknown route, right arm). On 25 September 2009, 30-60 minutes after vaccination with FLUARIX, the subject experienced stroke, with right-sided facial twitching, tremors and slurred speech. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were possibly related to vaccination with FLUARIX.					Y	0			U	09/25/2009	09/25/2009	0	UNK	PUB	PUB	Fish Oil;  Calcium carbonate+vitam. D;  Venlafaxine hydrochloride;  Triamterene + HCTZ;  Vitamin E;  Donepezil HCL;  Celecoxib;  AMLODIPINE;  SIMVASTATIN;  Cyanocobalamin;  Lignocaine hydrochloride;  Potassium salt;  Vitamin D;  Ibandronate	High cholesterol;  Osteoporosis	The subject has received FLUARIX for the last three years with no complications. The subject has not experienced adverse events following previous vaccinations.		A0809622A	1						1	Cerebrovascular accident; Dysarthria; Muscle twitching; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA470BA~1~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0359066	10/01/2009	DC	77.0	77		F	10/01/2009	Anaphylaxis shock. Angioedema. Death.	Y	10/25/2008		Y	Y	5			N	10/13/2008	10/14/2008	1	Blood sugar - Accucheck 444/424	PVT	OTH	NOVOLOG; Insulin; Glypizide; Benazepril, etc.	Diabetes; Hyperlipidemia	Hypertension; Arteriosclerosis; Anemia; Glaucoma, etc.			1						1	Anaphylactic shock; Angioedema; Blood glucose increased; Death	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~08132~5~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0359067	10/01/2009	NC	61.0	61		M	10/01/2009	Pt in Rex ED 9/19 with worsening hives not responsive to home use of benadryl. Pt states he got the flu vaccine 9/17 and later that day developed scattered hives, then reports worsening scattered hives and itching. 9/19 he was awakened from his sleep by the itching and hives on arms and back, and presented to ED 05:20 AM. He reports no previous reaction to any flu shot in the past and denies new meds or insect bites. Rx'd prednisone 60mg po (and given oral steroid taper rx for home x 6 days), pepcid 20mg po, benadryl 25mg po q6h prn. Monitored to see that symptoms were no longer progressing and was discharged to home and referred to allergist. Per discharge summary: acute urticarial hive reaction 2 flu vaccine or preservative in the flu vaccine. There is no information regarding what type of flu vaccine was given, where given, lot #'s, pt has no PCP listed.  Pt was discharged in improved condition. Rex Healthcare ED is in Wake County, NC but there was no information about where the pt got his flu shot.				Y					U	09/17/2009	09/17/2009	0	None	UNK	UNK	aspirin, niacin, lisinopril, metformin, simvastatin, glipizide, prilosec		HTN, TYPE 2 DM, allergic to shellfish, 61 yo black male			1						1	No reaction on previous exposure to drug; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~?~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0359069	10/01/2009	AZ	11.0	11		M	10/01/2009	Patient leaned over to look at something on floor and had a syncopal event.  Fell off exam table hitting floor.				Y					U	10/01/2009	10/01/2009	0	pulse ox 100% on RA., BP 106/58; pulse 82	PVT	PUB	none		none			1						1	Fall; Oxygen saturation normal; Syncope	FLU3~SANOFI PASTEUR~U3201AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B038CA~1~IM~LA~TDAP (BOOSTRIX)~1	USA	Emergency room visit	Influenza
0359070	10/01/2009	PA	16.0	13		M	10/01/2009	Patient had syncopal episode with decrease in BP to 77 systolic, recovered given water subsequent BP systolic 106.  Left without incident									Y	10/01/2009	10/01/2009	0		UNK	PUB	Ceftriaxone		None			1						1	Blood pressure decreased; Syncope	FLU3~SANOFI PASTEUR~U3208AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359071	10/01/2009	AZ	30.0	30		F	10/01/2009	3 hours after immunization, patient had signs and symptoms of soreness throughout body, nausea, vomiting, paleness, diaphresis, and chills. Signs and symptoms lasted approximately 24 hours. Pt stated she had taken Tylenol shortly after signs and symptoms started.									Y	09/29/2009	09/29/2009	0	N/A	UNK	UNK	NONE	NONE	Codeine	N/A~ ()~NULL~~In Patient|N/A~ ()~NULL~~In Sibling1|N/A~ ()~NULL~~In Sibling2		1						1	Chills; Hyperhidrosis; Nausea; Pain; Pallor; Vomiting	FLU3~CSL LIMITED~07849111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359073	10/01/2009	NY	2.0	2	.9	F	10/01/2009	Pt developed hives after receiving Flu shot. Pt came to clinic today and received Benadryl and Orapred prescriptions.				Y					U	09/30/2009	09/30/2009	0		PVT	PUB		None				1						1	Urticaria	FLU3~SANOFI PASTEUR~ut3178da~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359074	10/01/2009	IN	24.0	24		F	10/01/2009	Pt received first ever seasonal flu vaccine on 9/30/09. Also, pt was on final day of taking Bactrim for UTI. This was also the first time she had taken Bactrim. Pt broke out in hives and had chills that evening. Seen today at HealthLinc. Still had rash. Pt denied any problems with difficulty breathing. Pt denied allergy to eggs. Vaccine manufacturer is ID Biomedical of Quebec. HealthLinc is a FQHC.										09/30/2009	09/30/2009	0		UNK	UNK	Naproxin,  ibuprofen,  Tamodal,  SMZ-TMP DS 800/160	urinary tract infection	penicillin			1						1	Chills; Rash; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA261AA~UNK~IM~~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0359075	10/01/2009	OH	50.0	50		F	10/01/2009	SX: Fever with violent shaking, cough, throat burning and felt like unable to breathe, stridor, severe eye itching/watering, sinuses with copious mucus drainage, voice very hoarse. Heart racing to the point of chest pain. Symptoms began about 4 hours after injection. TRX: Zyrtec 10 mg. po, Nasocort nasal spray 2 to each nostril, Tylenol 625 mg PO, Zicam 1 tablet dissolved in mouth all taken about 45 minutes after symptoms started and symptoms started to abate about 40 minutes after that.				Y					Y	09/29/2009	09/29/2009	0	none	PVT	UNK	Lexapro 10 mg po daily; Zyrtec 10 mg po daily;	none	none			1						1	Chest pain; Cough; Dysphonia; Dyspnoea; Eye pruritus; Lacrimation increased; Palpitations; Pyrexia; Sinus congestion; Stridor; Throat irritation; Tremor	FLU3~SANOFI PASTEUR~63300AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359076	10/01/2009	FL	44.0	44		F	10/01/2009	PATIENT RECEIVED VACCINATION AND APPROX 1HR AFTER SHOT BEGAN HAVING SHOOTING PAIN IN LEFT WRIST AND FINGERS.  PATIENT REPORTED HAVING DIFFICULTY RAISING ARM  WITHOUT ASSISTANCE FOR SEVERAL DAYS FOLLOWING INJECTION.  PATIENT REPORTED PAIN INITIALLY BUT ATTRIBUTED TO NORMAL REACTION TO FLU SHOT.  PAIN CONTINUED FOR 3+ WEEKS AND THERE CONTINUED TO BE PAIN WHEN RAISING ARM ABOVE HEAD DESPITE TAKING ANTI-INFLAMATORY MEDICATION FOR AN UNRELATED CONDITION.  PATIENT REFERRED TO WORKERS COMP DOCTOR WHO EXAMINED AND PRESCRIBED MEDICATION BUT PATIENT HAS NOT FILLED PRESCRIPTION.  PATIENT IS RECOVERING WELL ALTHOUGH STILL EXPERIENCES SOME PAIN AND DISCOMFORT.				Y					Y	09/01/2009	09/01/2009	0	NONE	PUB	PUB	ANTI-INFLAMATORY, COULD NOT RECALL NAME.		BURSITIS IN KNEE, TAKING ANTI-INFLAMATORY			1						1	Arthralgia; Discomfort; Mobility decreased; Pain; Pain in extremity	FLU3~SANOFI PASTEUR~PMC U319AA~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359077	10/01/2009	FL	51.0	51		F	10/01/2009	PATIENT RECEIVED INFLUENZA VACCINE AND ABOUT 2.5 HRS LATER ARM BECAME VERY SORE AND WARM.  INJECTION SITE WAS SORE AND BRUISED FOR SEVERAL DAYS.  PATIENT ATTRIBUTED REACTION TO NORMAL FLU SHOT SYMPTOMS.  PATIENT HAD PAIN IN UPPER ARM WHEN ARM LIFTED BEYOND 90 DEGREE ANGLE.  PAIN WAS STILL PRESENT 3+ WEEKS POST IMMUNIZATION AND WORSENED IN LATER PART OF DAY. PATIENT SAW PHYSICIAN ON 9/28 AND RECEIVED A CORTIZONE SHOT.  PATIENT ALSO RECEIVED SCRIPT FOR METHPREDNISOLONE AND IBUPROPHEN 800MG WHICH SHE STARTED ON 9/29.  PATIENT NOTICED IMMEDIATE RELIEF FOLLOWING CORTIZONE SHOT AND CONTINUES TO RECOVER ALTHOUGH STILL EXPERIENCING SOME DISCOMFORT.				Y					Y	09/01/2009	09/01/2009	0	NONE	PUB	PUB	VASOMEX (FOR BONE DENSITY)		ALLERGY TO CODINE & SULFA, RECEIVES TX FOR SEASONAL AND ENVIRONMENTAL ALLERGIES			1						1	Injection site haematoma; Injection site pain; Pain; Skin warm	FLU3~SANOFI PASTEUR~PMC U319AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359078	10/01/2009	CA	0.6	0	.6	F	10/01/2009	LOW TEMP. CONSTANT SCREAMING FOR MORE THAN 3 HRS. PER DR ALLERGY TO PERTUSSIS.									Y	09/30/2009	10/01/2009	1	NONE	UNK	UNK						1						1	Allergy to vaccine; Body temperature decreased; Screaming	DTAPIPVHIB~SANOFI PASTEUR~C3252AA~6~IM~LL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1445K~3~IM~LL~HEP B (RECOMBIVAX HB)~1	USA		Influenza
0359079	10/01/2009	CA	50.0	50		F	10/01/2009	Approximately 2 hours post vaccination patient experienced sore throat, hoarseness, and her tongue felt slightly swollen.  In addition, she complained of bilatteral eye swelling and redness.									Y	09/23/2009	09/23/2009	0	None	PUB	PUB	None	None	None			1						1	Dysphonia; Eye swelling; Ocular hyperaemia; Oropharyngeal pain; Swollen tongue	FLU3~SANOFI PASTEUR~3186AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359080	10/01/2009	CA	10.0	10		F	10/01/2009	herpangina posterior pharynx				Y					U	09/28/2009	09/30/2009	2	None.  Patient in office today, no tests done.	PVT	PVT				herpangina~Influenza (Seasonal) (no brand name)~NULL~6.00~In Sibling1		1						1	Herpangina	FLUN3~MEDIMMUNE VACCINES, INC.~500681P~7+~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0359082	10/01/2009	OR	19.0	19		M	10/01/2009	Patient called stating after getting flu vaccine yesterday that the site was extremely sore, he had a fever and felt chilled.									Y	09/30/2009	10/01/2009	1		UNK	PUB		no	no			1						1	Chills; Injection site pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA255AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0359084	10/01/2009	MD	73.0	73		F	10/01/2009	Severe sweating starting about one hour after receiving the influenza vaccination (Fluvirin -Novartis 5 mL PFS Lot #9712165P) and continuing for several hours.									Y	09/30/2009			None	UNK	UNK	None	No	No			1						1	Hyperhidrosis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~9712165P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359091	10/01/2009	LA	37.0	37		M	10/01/2009	Tenderness, pain swelling, wheal and flare @ injection site.										09/29/2009	09/30/2009	1		OTH	PVT						1						1	Injection site pain; Injection site swelling; Injection site urticaria	FLU3~SANOFI PASTEUR~U3210AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359092	10/01/2009	LA	35.0	35		F	10/01/2009	16:30-Started coughing, eyes red, throat itchy. 19:30 - eyes blurry, coughing, bloodshot eyes, spouse took to ER.  was treated with CORTISONE IM, ROCEPHIN IM, BENADRYL IM, 1 ltr fluids IV. 10-01-09 reports achy, eyes swollen, congested.				Y					Y	09/30/2009	09/30/2009	0	None	PVT	PVT	None	Non				1						1	Cough; Eye swelling; Ocular hyperaemia; Pain; Respiratory tract congestion; Throat irritation; Vision blurred	FLU3~SANOFI PASTEUR~U3210AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359093	10/01/2009	NJ	56.0	56		M	09/30/2009	Flu vaccination given 9/28/09 2:30 pm between 5 and 6 pm started to have frontal and left temporal headache, right posterior neck pain, and under right shoulder blade stabbing pain. Right and left calf muscle pain and foot pain.									U	09/28/2009	09/28/2009	0	None	UNK	UNK		None	allergies: Hives	Fever.~Influenza (Seasonal) (no brand name)~UN~0.00~Patient		1						1	Headache; Musculoskeletal pain; Neck pain; Pain in extremity	FLU3~SANOFI PASTEUR~U3173BA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359095	10/01/2009	ME	8.0	8		M	10/01/2009	Local erythema and induration after 1 day. On day 2 3 x 3 slightly tender.									U	09/29/2009	09/30/2009	1	None	PVT	UNK		None	None			1						1	Erythema; Induration; Tenderness	FLUN3~MEDIMMUNE VACCINES, INC.~500687P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~0996Y~2~UN~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0359096	10/01/2009	TX	2.0	2	.1	M	10/01/2009	Patient had unresponsive episode 10- 15 minutes after injection, lasted less than 5 minutes. No prior history of seizures, syncope episode occurred in local store.				Y					Y	10/01/2009			were While in ED, recovered without obvious sequelae.	PUB	PUB	None	None	None			1						1	Syncope; Unresponsive to stimuli	FLU3~SANOFI PASTEUR~U3174CA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359097	10/01/2009	NY	44.0	44		F	10/01/2009	Itching site following injection, scalp itching, feet itching later in day-used antihistamine. Continued soreness at site, large red area at injection site 2 days later.									Y	09/29/2009	09/29/2009	0	None	PVT	PVT	YAZ; AVAPRO	None				1						1	Injection site erythema; Injection site pain; Injection site pruritus; Pruritus	FLU3~SANOFI PASTEUR~U3184AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359098	10/01/2009	IL	1.02	1	.0	M	10/01/2009	Red papular rash over trunk arms since 9/26/09. 9/28 T-101.4									U	09/18/2009	09/26/2009	8	None	PVT	UNK		None	None			1						1	Body temperature increased; Rash papular	FLU3~SANOFI PASTEUR~UT3171DYA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0763Y~1~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0975~1~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0359101	10/01/2009	OH	59.0	59		F	10/01/2009	itching down vaccine administered arm and forehead and lower back, said whole inside of arm got red. Occurred 15 minutes post administration, face is warm. Gave BENADRYL 50mg observed for 15 minutes. No escalation									U	10/01/2009	10/01/2009	0		OTH	PVT						1						1	Erythema; Injection site pruritus; Pruritus; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846PZ~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359102	10/01/2009	PA	9.0	9		F	10/01/2009	Chest pain, chest tightness, shortness of breath									U	09/30/2009	10/01/2009	1		PVT	PVT		None	Hx Benign brain tumor. S/P removal			1						1	Chest discomfort; Chest pain; Dyspnoea	FLU3~SANOFI PASTEUR~U3207AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359103	10/01/2009	PA	14.0	14		F	10/01/2009	Chest pain, chest tightness, shortness of breath.									U	09/30/2009	09/30/2009	0		PVT	PVT		None				1						1	Chest discomfort; Chest pain; Dyspnoea	FLU3~SANOFI PASTEUR~U3207AAA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359104	10/01/2009	WI	42.0	41		F		Called 2 days post vaccination reporting blotchy hives all over face.									U	09/29/2009	09/30/2009	1		OTH	PVT	None	None	Factor Eleven			1						1	Rash macular; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838PI~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359105	10/01/2009	IL	62.0	62		F	10/01/2009	Pain in L arm evening of vaccination - 9/29/09, redness/swelling/pain at injection site and further into left upper arm mostly on 9/30/09.  Cellulitis upon exam 10/1/09- prescribed KEFLEX 500 TID and 10 days CLARINEX 6mg QD x 10 days, and BENADRYL OTC Q6-8h until resolved. Pt to follow up in office in 4 days.									Y	09/29/2009	09/29/2009	0	None	PVT	PVT	BENICORT 20/12.5 QD; PROZAC 20 mgQD; XANAX 0.5mg TID PRN; ALBUTEROL PRN; ADVAIR 250/50; OMEPRAZOLE 20mg	None	NKDA; GERD; HTN; Anxiety/depression.			1						1	Cellulitis; Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U3259GA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1076X~1~IM~LA~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~0746Y~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0359107	10/01/2009	CA	62.0	62		F		Extreme back ache, woke up during night, took 2 ibuprofen, 2 or 3 hours before extreme pain subsided. Continued to take ibuprofen did not reoccur. It took 3-4 hours to get rid of it after wakening to get rid of it.									Y	09/21/2009	09/21/2009	0		OTH	PVT	GABAPENTIN; CELEBREX; COMBIVENT; Centrum silver for women; iron; Ca 2+; vitamin C	No	Arthritis; degenerative disc; COPD			1						1	Back pain	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~MERCK & CO. INC.~~UNK~UN~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0359111	10/01/2009	CA	76.0	76		F	09/30/2009	Pt had flu and pneumonia on 9/29/09.  Pt returned on 9/30/09 and showed R deltoid (pneumo injection) red inflamed. Pt as advised by pharmacy went to ER and was given KEFLEX 500mg by PO QH as prophylaxis for possible skin infection.				Y					U	09/29/2009	09/29/2009	0		OTH	PUB		None				1						1	Injection site erythema; Injection site inflammation	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~05Z7Y~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0359112	10/01/2009	CA	57.0	57		F	09/30/2009	-Pt reported itchy welt form at injection site after 4 hrs. RPH advise pt to call MD and to take BENADRYL for the itchiness. - Pt got vaccine 9/29/09 but reported to R ph on 9/30/09 around 3pm.									U	09/29/2009	09/29/2009	0	None	OTH	OTH	None	None	Peaches/nectarines			1						1	Injection site pruritus; Injection site urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848PIC~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359114	10/01/2009	CA	62.0	61		F	10/01/2009	Contacted patient 9/30/09 to refund admin charge - she then told me of reaction - generalized felt bad out of it Headache. I asked 4-5 dx - recurred but will not get another pneumonia shot had flu shots previously - no problems.									Y	09/02/2009	09/02/2009	0		OTH	PVT						1						1	Feeling abnormal; Headache; No reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~U3190AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1162X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359115	10/01/2009	TX	60.0	60		F	10/01/2009	Starting on day of immunization had pain post + ant. L shoulder, which has progressively worsened.				Y					N	09/23/2009	09/23/2009	0	x 100 my-10ct-Normal	MIL	UNK	Fentanyl, Mobic, Gabapentin, Cymbalta	None	NKOA; Degenerative arthropathies			1						1	Musculoskeletal pain; X-ray normal	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0359116	10/01/2009	ID	52.0	52		F	10/01/2009	Lump appeared immediately 1 1/2 in diameter. no shortness of breath, no numbness or tingling.  No treatment.									Y	10/01/2009	10/01/2009	0	None	PVT	OTH	EVOXAC; CELEXA; BUPROPION	No	Sjogren's disease			1						1	Immediate post-injection reaction; Mass	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98442PIB~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359118	10/01/2009	WI	58.0	58		F	10/01/2009	Large bruise on arm									U	09/21/2009	09/21/2009	0		PUB	PUB	None	None	None			1						1	Contusion	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359119	10/01/2009	WI	61.0	61		F	09/30/2009	Patient called and stated she had blotches on right upper arm following administration of pneumococcal vaccine.  Counseled pt to consult her physician.									U	09/28/2009	09/28/2009	0		OTH	PVT						1						1	Rash macular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2A~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0632Y~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359125	10/01/2009	AZ	1.1	1	.0	F	10/01/2009	Patient developed a raised macula - 1.5 x 0.5 cm on L thigh next to the VZ vaccine site right after vaccination was given 14:05, pt was given children's BENADRYL macula disappeared and slight flat macula.  Pt was observed for 45 min in office.									Y	09/29/2009	09/29/2009	0	None	PVT	PUB	None	Well children exam, no illness	None			1						1	Immediate post-injection reaction; Injection site macule	FLU3~SANOFI PASTEUR~U32596A~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB342AA~1~UN~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0554Y~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~D59297~4~UN~RL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~09924~1~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0359132	10/01/2009	MI	29.0	29		F	09/25/2009	Redness, swelling, warn to touch 24 p receiving infuenza/pneumovax in L arm. Deltoid.									Y	09/22/2009	09/23/2009	1		PVT	UNK						1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3189AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0024Y~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359135	10/01/2009	OH	66.0	66		F	09/27/2009	Severe vertigo, couldn't stand. Nausea, vomitting cold clammy skin, sweating, was given cat scan, treated with Antinausea & Antivertigo IV. Was diagnosis by ER as laby-Rinthitis, unknown origin suspected Flu vaccine reaction.				Y					Y	09/18/2009	09/18/2009	0	CAT & Blood work	OTH	PUB	Unknown	None	None known	none~ ()~~0.00~Patient		1						1	Blood test; Cold sweat; Computerised tomogram; Dysstasia; Hyperhidrosis; Immunisation reaction; Labyrinthitis; Nausea; Peripheral coldness; Vertigo; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359136	10/01/2009	CO	10.0	10		M	09/28/2009	-Patient given Flu shot & blacked out about 15 min later in store. Patient had faint pulse so given Epipen Jr. 0.15 mg & remained stable until EMT/paramedics arrived 5-10 min later. (shot given @ 12:45-black out at 1:00 pm) - patient taken to Montrose Mem. ER & discharged- patient doing well verified w/mom and RN @ hosp. (PT ok). Doing fine verified w/ mom.				Y					Y	09/26/2009	09/26/2009	0	None (possible Vasovagal rxn RN Hosp stated?)	OTH	OTH	None	None	Asthma			1						1	Loss of consciousness; Pulse pressure decreased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359137	10/01/2009	GA	62.0	62		F	09/26/2009	Pt. received vaccine 9-24-09. Red rash around injection site occured 9-25-09 with fever and itching. Pt also suffered from severe headache and redness in the left eye. A blood vessel ruptured in that eye. She came by the pharmacy 9-26-09 to ask about symptoms.									Y	09/24/2009	09/25/2009	1		OTH	PVT		None				1						1	Eye haemorrhage; Headache; Injection site erythema; Injection site rash; Ocular hyperaemia; Pruritus; Pyrexia	FLU3~CSL LIMITED~08549111A~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359138	10/01/2009	PA	61.0	60		F	09/25/2009	Lower leg weakness - left > right - 5 days after vaccination and persisting for a few weeks (similar reaction each of the last 3-4 yrs after INFLUENZA vaccine). In past, yes. Still symptomatic now.									N	09/08/2009	09/14/2009	6	NCS/EMG 1 yr ago - no neuropathy	PVT	OTH	ASPIRIN; ATENDOL; vitamin B-12; PREMPHASE	None	Cephalosporins; AMOXICILLIN; sulfa-rash; CODEINE; PRILOSEC; LEVAQUIN - confusion and sedation	leg weakness~Influenza (Seasonal) (no brand name)~UN~58.00~Patient		1						1	Muscular weakness; Similar reaction on previous exposure to drug	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97843P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359140	10/01/2009	CT	63.0	63		F	09/27/2009	Since the date of immunization I incounter pain in my upper right arm (muscle area) feel like hard knot, extreme pain normally while lying down at any time lasting up to 48 hrs. Reported to my physician during routine physical who stated could be hemdtoma.									N	11/04/2005	12/01/2006	392	N/A	OTH	PVT		None	None			1						1	Injection site induration; Injection site pain	FLU3~SANOFI PASTEUR~111910AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1007P~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359141	10/01/2009	NJ	74.0	74		M	09/26/2009	Vaccination 9/24/09-10:45 AM No problem initially 9/25/09 - site sore & arm stiff - Rt 9/26/09 - Rt upper arm, from above vaccination site to mid upper arm, swollen, red & warm to touch. Visit to MD-> Levoquin 500 mg OD - started 9/26/09 12:30 pm.				Y						09/24/2009	09/25/2009	1	None	PUB	UNK		Denied				1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U3207AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1296Y~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0359143	10/01/2009	NY	48.0	48		F	10/01/2009	45 minutes post-injection, wrist/thumb started getting sore, then progressed through the night. Pt woke up at 3 AM in extreme pain from thumb/wrist area radiating up arm. Flexing fingers made pain worse. Pt took 1000 mg of acetaminophen and pain was brought down to a 5/10 where she is currently.									N	09/30/2009	09/30/2009	0		OTH	PVT	LISINOPRIL/HCTZ 20/12.5	None	Scoliosis			1						1	Arthralgia; Pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359144	10/01/2009	IL	25.0	25		F	09/29/2009	C/o headache and palpitations, nausea. Treatment: REGLAN 10 mg PO x 1, BENADRYL 10 mg PO x 1.				Y					Y	09/16/2009	09/16/2009	0	EKG-84, sinus rhythm	PUB	PVT	LEXAPRO 10 mg PO dly	No	History of headaches			1						1	Electrocardiogram; Headache; Nausea; Palpitations; Sinus rhythm	FLU3~CSL LIMITED~05649111A~1~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0359145	10/01/2009	MI	61.0	61		F	09/30/2009	Tenderness began day of injection-AM of 30th, deltoid area painful, reddened, hot to touch, no temperature, no drainage. Decreased redness 10-01-09, 7:15 AM, cold compress applied several times 09-30-09, cont to apply cold compress 10-01-09.									Y	09/29/2009	09/29/2009	0	None	OTH	OTH	Vitamins	No	All antibiotics; VICODIN; morphine sulfate			1						1	Injection site erythema; Injection site pain; Injection site warmth; Tenderness	FLU3~SANOFI PASTEUR~U3192AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359149	10/01/2009	MA	48.0	48		M	10/01/2009	Pt had FLUZONE and PNEUMOVAX vaccine on 9/23/09. Next morning sxs=aches, HA, diaphoresis, L shoulder cellulitis at injection site. Antibiotics given via IV.				Y					Y	09/23/2009	09/24/2009	1		PUB	PUB		None	None			1						1	Headache; Hyperhidrosis; Injection site cellulitis; Pain	FLU3~SANOFI PASTEUR~U3208AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0627Y~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0359151	10/01/2009	MI	21.0	21		M	09/22/2009	-Body aches, tiredness, swelling of the throat, back pain starting about 3 hours after shot administration - treated by toradol IV.				Y					Y	09/16/2009	09/16/2009	0		OTH	PVT	None	None	None			1						1	Back pain; Fatigue; Pain; Pharyngeal oedema	FLU3~SANOFI PASTEUR~U3167DA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359085	10/02/2009	CA	48.0	48		F	10/01/2009	AFTER OVER 5 MINUTES FROM GETTING THE FLU SHOT,PER PATIENT, SHE EXPERIENCED DIZZINESS,FAINTING IN THE BEGINNING THEN SHE MENTIONED SHE FELT TINGLING ON HER TOES & FINGERS.SHE ALSO FELT NAUSEATED LATER ON.				Y					Y	10/01/2009	10/01/2009	0	PER CONVERSATION WITH HUSBAND ON PHONE @9PM 10-1-09....PT WENT TO HER DOCTOR & WAS DIAGNOSED WITH ANXIETY-RELATED TO GETTING INJECTION & PT ALSO HAS SINUS INFECTION & WAS GIVEN ANTIBIOTIC & PHENERGAN FOR NAUSEA & WAS ALSO GIVEN IV FOR HYDRATION.I WAS TOLD BY PTS HUSBAND DR SAID HER RXN WAS NOT DUE TO THE MEDICINE.	UNK	UNK		ASKED & WAS TOLD BY PT NO MEDICAL CONDITION.ONLY THING SHE MENTIONED WAS HAD FAINTED IN PAST GETTING INJECTION BECAUSE OF THE IDEA OF GETTING A SHOT	PER PT TOLD ME NO KNOWN MEDICAL CONDITION.ALLERGIC TO SULFA ONLY & HAD FLU SHOTS BEFORE WITH NO PROBLEM WITH IT			1						1	Dizziness; Nausea; Paraesthesia; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359109	10/02/2009	MD	40.0	40		F	09/25/2009	Employee described itching @ site within few minutes of injection, redness @ site, extending to arm and L ear. She took her own prescriptions for Benadryl, Prednisone and advil. Went to bed. Woke up with rash/hives in patches on her body; back, tummy, chest, legs, arms. She took benadryl, prednisone & Zyrtec. Next day she had no rash, but still had itching. Took benadryl. She went to work and at the end of her shift, her hands were itching and beginning to swell. Took Benadryl again. Today 9.25, she reports no itching, no rash, no symptoms.									Y	09/21/2009	09/21/2009	0	N/A	UNK	PVT	TOPAMAX 25mg qd, VitC qd, HCTZ 12.5 qd	N/A	Asthma-when have bronchitis -> wheeze			1						1	Injection site erythema; Injection site pruritus; Oedema peripheral; Pruritus; Rash; Urticaria	FLU3~CSL LIMITED~06849111A~UNK~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359110	10/02/2009	PA	47.0	47		M	10/02/2009	Pt received pnuemococcal 23-valent vaccine at 1800 on 10/1/09 to the right upper posterior arm. Vaccine info includes: Merck & Co, INC., Lot 0507Y, expiration 07/22/10, 0.5 ml sub-q. At 2330 on 10/1/09 pt c/o feeling an egg on his arm when he tried to lay on his right side. Palpation to area revealed a cherry tomato sized round lump that caused discomfort but no pain to pt. Area was not erythematous or warm to touch. Spoke with pharmacist regarding reaction as an email had been sent to nursing staff on 9/17/09 regarding potential issues with Pneumovax vaccines. Pharmacist advised to apply ice to area. If no relief or worseneing of symptoms she advised to contact MD regarding findings. Ice applied and pt slept for 3. hours without incident. Pt was awoken at 0330 for bloodwork and upon reassessment of area it was found that the area had grown in size to the size of a large plum. Area was now painful at 6/10; still no redness or erythema noted. Pt given 20 mg roxicodone and MD contacted. Obtained order to administer 25 mg Benadryl now, and another 25 mg if no response in an hour. Benadryl 25-50 mg was also ordered q4-6 prn. Benadryl given at 0500 and pt now resting comfortable. Pt reports a decrease in pain to 4/10 after administration of pain medication. After one hour site is still swollen but less firm. Second dose of 25 mg Benadryl given po at 0630.									Y	10/01/2009	10/01/2009	0		UNK	UNK	Tylenol, allopurinol, amlodipine, docusate-senna, Neurontin, oxycontin, roxicodone, vancomycin, Benadryl	LLE cellulitis	Hypertension, diabetes type 2 (resolved following gastric bypass)			1						1	Feeling abnormal; Mass; Oedema peripheral; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~96031~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0507Y~1~SC~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359113	10/02/2009	MO	55.0	55		F	09/25/2009	Patient presented roughly 25 minutes after receiving vaccine with itching of face and a blotch below right eye. Pt was given 2 25 mg Diphenhydramine tabs and had no further complaints.									Y	09/25/2009	09/25/2009	0		OTH	OTH	Unknown	Unknown	Unknown			1						1	Pruritus; Rash macular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359117	10/02/2009	WA	0.79	0	.8	F	09/26/2009	Small raised red bumps left cheek & right corner of mouth, also one bump rt thigh. Temp 100.4 02 Sat 98%.									Y	09/26/2009	09/26/2009	0	Temp 100.4 R 02 Sat 98%.	PVT	PUB		None				1						1	Body temperature increased; Cheilitis; Erythema; Oxygen saturation; Rash papular	FLU3~SANOFI PASTEUR~U3259BA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359120	10/02/2009	SC	62.0	62		F	10/01/2009	Approximately one hour after shot, felt soreness in arm where injection given. Subsequently the same day felt aching in muscles in arms, shoulders and hips on both sides. Aching persisted, 3 weeks, but is resolved now except in left shoulder and left hip.									N	09/11/2009	09/11/2009	0	None	OTH	PVT	Prempro, Fluoxetine	None	Prior history of Hepatitis C, NKDA	None~ ()~~0.00~Patient		1						1	Arthralgia; Musculoskeletal pain; Myalgia; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~9841P2~6~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359121	10/02/2009	OH	15.0	15		M	09/25/2009	Approx. 1 1/2-2 hrs. after FLUMIST, HAVRIX #2, dizzy, heart pounding, tired, weak, acted weird, moving slow, speech slow. Patient went to emergency room-no treatment.				Y					U	09/24/2009	09/24/2009	0	Urine drug screen-negative	PVT	PUB	None	Drainage in throat/slightly sore	None			1						1	Abnormal behaviour; Asthenia; Dizziness; Drug screen negative; Fatigue; Hypokinesia; Palpitations; Speech disorder	FLUN3~MEDIMMUNE VACCINES, INC.~500707P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB296BA~2~UN~LA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0359122	10/02/2009	MA				U		Redness, hot, hot flashes. L upper arm redness, swelling, pain. R ant chest with pain-hot flash, diaphoresis.													Eval-BIDN ER	PVT	UNK			PENICILLIN, HTN, CAD			1						1	Chest pain; Erythema; Feeling hot; Hot flush; Hyperhidrosis; Oedema peripheral; Pain in extremity	FLU3~CSL LIMITED~0234921A~UNK~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359124	10/02/2009	PA	6.0	6		M	10/01/2009	8 x 10 cm erythematous welt at injection site-started within 24 hrs and progressed.				Y					N	09/29/2009	09/30/2009	1		PVT	PVT						1						1	Injection site erythema; Injection site urticaria	FLU3~SANOFI PASTEUR~U3199AA~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359126	10/02/2009	OR	20.0	20		F	10/01/2009	Pt. c/o nausea/vomiting with fever for approx 24 hours.									Y	09/29/2009	09/30/2009	1	None	PVT	PVT	YASMIN; Amitriptyline	None	NKDA			1						1	Nausea; Pyrexia; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P2A~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359128	10/02/2009	GA	34.0	34		F	10/01/2009	Within approx 25 minutes after FLUZONE, felt a seering hot pain down left arm for a second and went away. Then went to office, noticed left great thumb swelling within 1 1/2 hours. 24 hrs. later, still the same size. Has used ice.				Y					U	09/30/2009	10/01/2009	1		PVT	UNK		None	Allergy to PENICILLIN (rash)			1						1	Feeling hot; Oedema peripheral; Pain; Pain in extremity	FLU3~SANOFI PASTEUR~U3213AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359129	10/02/2009	WV	41.0	41		F	10/01/2009	Pt dev sl.  L periorbital swelling, dizziness and some tightness in throat, about 20 mins after she read the latex free preservative free Influenza (seasonal) vaccine.  her symptoms were resolved after she took BENADRYL 25mg and later CETRIZINE 10mg. She was observed for one hour with meds without event. She declined BENADRYL 50mg. But will take 25mg 48 hrs.									Y	10/01/2009	10/01/2009	0	She has rec'd 3 prior latex free flu vaccine without probs in prior years.	PUB	OTH	INDERAL 120mg daily	None	Latex; Allergy to pollen, grasses, high fat dairy; migraines; Insulinemia			1						1	Dizziness; Eye swelling; Throat tightness	FLU3~SANOFI PASTEUR~U3253DA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359130	10/02/2009	NY	45.0	45		M	10/01/2009	Patient complained of headache after a few minutes of FLUVIRIN vaccine. Called pat later time to follow up, per pat still has HA. Informed pat. to contact MD of headache, per MD service.									U	09/26/2009	09/26/2009	0		OTH	UNK						1						1	Headache	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359131	10/02/2009	PA	16.0	16		F	09/25/2009	Per ER; allergic rxn - probably to flu shot.				Y					Y	09/14/2009	09/14/2009	0		PVT	OTH						1						1	Hypersensitivity	FLU3~SANOFI PASTEUR~U3212AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359133	10/02/2009	NY	36.0	36		F	10/01/2009	sore throat following shot. by evening shaking, chills, temp 102.5, fever still next am. Started on TAMIFLU 10/1/09									U	09/30/2009	09/30/2009	0	None	PVT	PVT	None	Positive exposure to H1N1	none			1						1	Body temperature increased; Chills; Oropharyngeal pain; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U3207AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359134	10/02/2009	KY	50.0	50		F	10/01/2009	Rec'd flu and pneumonia shot on 9/28/09. In PM had increased pain and swelling in L arm flu shot given (double in size down to wrist). L side neck swollen & SOB. Called ER - took BENADRYL. Called doc and PCP. Hx anaphylaxis in past form medicine.									Y	09/28/2009	09/28/2009	0		PUB	OTH	TRAMIDOL; KLONIPIN; SYMBICORT; PROVENTIL; PREMARIN; SYNTHROID; SPIRIVA; THEOPHYLLINE; ASTHMANEX;	None	COPD; Asthma; Emphysema; Thyroid; (PCN, Keflex, Librium, Bee Stings; iodine)			1						1	Dyspnoea; Injection site pain; Injection site swelling; Local swelling	FLU3~SANOFI PASTEUR~93AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0509Y~2~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359139	10/02/2009	WA	74.0	74		F	09/24/2009	Redness at injection site on both arms R > L Patient reports similar reaction to penicillin injections.									Y	09/17/2009	09/17/2009	0		PVT	PVT		None	Penicillin, sulfa			1						1	Injection site erythema	FLU3~CSL LIMITED~07849111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|PNC~PFIZER\WYETH~0632Y~UNK~IM~LA~PNEUMO (PREVNAR)~1|TD~SANOFI PASTEUR~AQ12C~UNK~IM~LA~TD ADSORBED (NO BRAND NAME)~1	USA		Influenza
0359148	10/02/2009	CA	18.0	18		F	09/24/2009	(Radial nerve neuritis per MD) - c/o right arm numbness and tingling 1 1/2 hrs. after vaccine.  9/25/09 pts feeling better									U	09/23/2009	09/24/2009	1	None	OTH	PVT	VERAMYST	None	None			1						1	Hypoaesthesia; Neuritis; Paraesthesia	FLU3~CSL LIMITED~02049211A~UNK~UN~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359150	10/02/2009	OH	65.0	65		F	09/28/2009	Given vaccine around 2:30 9-18-09. Patient reported on 9-24-09 she had been taken by squad on 9-18-09 about 7:00 pm to Hospital. Symptoms included dizziness, nasea vomiting, gray & clammy skin, blood pressure 60/40. Almost passed out. No conclusive Diagnoisis. Suspected reaction to Flu vaccination.				Y					Y	09/18/2009	09/18/2009	0	Unknown	OTH	PUB	Unknown	None	None	None~ ()~~0.00~Patient		1						1	Cold sweat; Cyanosis; Dizziness; Hypotension; Immunisation reaction; Nausea; Presyncope; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P2~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0632Y~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0359153	10/02/2009	TX	22.0	22		F	09/24/2009	Patient received Influenza shot. Fifteen minutes later patient became nauseated. Patient remained seated, blood pressure was taken (117/90). After 10 more minutes patient went back to work. No temp or fever. Called pt am 9/24/09- she said ok and went back to work yesterday 9/23.09. P.S. Talked with patient next a.m. (9/24/09). Patient ok and stated she returned to work evening after shot. Patient appreciated call.									Y	09/23/2009	09/23/2009	0		OTH	OTH	METHOTREXATE tabs	None	None			1						1	Nausea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~47843P2~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359154	10/02/2009	VA	50.0	50		M	09/23/2009	Chills, HA, body aches, dizzy, pain in neck....On 9/23/09 pt went to ER and DX flu then returned 9/25 with urinary retention and required indwelling cath.				Y					U	09/21/2009	09/22/2009	1	None	OTH	OTH		None	Seizures			1						1	Chills; Dizziness; Headache; Influenza; Neck pain; Pain; Urinary retention	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA257CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0359155	10/02/2009	IN	75.0	75		M	09/25/2009	Hives. BENADRYL and famotidine.									Y	09/24/2009	09/24/2009	0		PVT	PVT		None	None			1						1	Urticaria	FLU3~SANOFI PASTEUR~U3184AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359160	10/02/2009	MI	3.0	3		F	10/02/2009	Hives; occurred 2-6 hours after event; resolved with oral Benadryl, topical treatment									Y	10/01/2009	10/01/2009	0	Not applicable	PUB	PVT	Keppra for two years; no prior reactions	None	Seizure disorder, controlled			1						1	Urticaria	FLU3~SANOFI PASTEUR~U3196AA~3~SC~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359161	10/02/2009	LA	51.0	51		F	10/02/2009	Fever, body aches, chills for 2 days.  Temp 103 first day, 100 2nd day, and 99 3rd day.									Y	09/29/2009	09/30/2009	1	n/a	MIL	PVT	Cholesterol meds and Lexapro	none	Demerol, Mandol allergies.  Treated for hyperlipidemia.  Takes Lexapro for anxiety.			1						1	Chills; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA279AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0359162	10/02/2009	MO		6		M	10/02/2009	this patient was given afluria which is only to be give to 18 and older. No reaction to vaccine.									Y	09/14/2009				UNK	UNK						1						1	Inappropriate schedule of drug administration	FLU3~CSL LIMITED~0584911A~2~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359163	10/02/2009	MO		5		F	10/02/2009	This patien was give afluria which is only to be given to 18 and older.                          I-92579218 and I-92318744									Y	09/14/2009				UNK	UNK						1						1	Inappropriate schedule of drug administration	FLU3~CSL LIMITED~0584911A~2~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359164	10/02/2009	MO		7		F	10/02/2009	This patient was give afluria which is only to be given to 18 and older.  no Reaction to vaccine.  I-92579218 and I-92318744									Y	09/15/2009				UNK	UNK						1						1	Inappropriate schedule of drug administration	FLU3~CSL LIMITED~0584911A~2~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359165	10/02/2009	MO		10		M	10/02/2009	This patient was given afluria which is only to be given to 18 and older. no reaction to vaccine.  I-92579218 and I-92318744									Y	09/15/2009				UNK	UNK						1						1	Inappropriate schedule of drug administration	FLU3~CSL LIMITED~0584911A~2~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359166	10/02/2009	MD	37.0	37		F	10/02/2009	Pt had a syncopal episode, fell and hit her head on the floor.  Became diaphoretic, Pulse 80/palp, pulse 42.  Immediately regained consciousness and was A&Ox3									Y	10/02/2009	10/02/2009	0	EKG- Sinus bradycardia at 49bpm, otherwise normal	PVT	UNK	Baraclude	None	Hepatitis B, under treatment			1						1	Electrocardiogram abnormal; Fall; Head injury; Heart rate decreased; Hyperhidrosis; Sinus bradycardia; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98437P1A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HPV4~MERCK & CO. INC.~1312x~2~IM~LA~HPV (GARDASIL)~1	USA		Influenza
0359167	10/02/2009	MO		4		F	10/02/2009	this patient was given afluria which is only to be given to 18 and older. no reaction.  I-92579218 and I-92318744									Y	09/16/2009				UNK	UNK						1						1	Inappropriate schedule of drug administration	FLU3~CSL LIMITED~0584911A~2~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359168	10/02/2009	MO	4.0	4		F	10/02/2009	This patient was given afluria which is only to be given to 18 and older. no reaction. I-92579218 and I-92318744									Y	09/16/2009				UNK	UNK						1						1	Inappropriate schedule of drug administration	FLU3~CSL LIMITED~0584911A~2~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359169	10/02/2009	MO		13		F	10/02/2009	this patient was given afluria which is only to be give to 18 and older. no reaction. I-92579218 and I-92318744									Y	09/16/2009				UNK	UNK						1						1	Inappropriate schedule of drug administration	FLU3~CSL LIMITED~0584911A~2~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359171	10/02/2009	NY	59.0	59		F	10/02/2009	red and burning eyes, oozing eyes, chills, fever, coughing, nasal congestion									U	10/01/2009	10/01/2009	0		OTH	OTH	HC 12 25 mg once a day, Potassium 20mEg once a day		None known			1						1	Chills; Cough; Eye discharge; Eye irritation; Nasal congestion; Ocular hyperaemia; Pyrexia	FLU3~SANOFI PASTEUR~UT3172BA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359172	10/02/2009	NY	49.0	49		F	10/02/2009	Vaccine given at 8:15 - throughout the morning tightness in chest developed - continued throughout the afternoon + itchiness developed. In the evening itchiness worsened + hives developed - cont. with chest tightness + developed coughing - took 50mg BENADRYL with relief. Still some what tight in chest today (next day) but able to work.									N	10/01/2009	10/01/2009	0	None	PUB	PVT	SYNTHROID, COREG, LISINOPREL	None	All- Sulfa + PCN, Hashimoto's thyroid			1						1	Chest discomfort; Cough; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U3205CA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359175	10/02/2009	MA	44.0	44		F	10/02/2009	PT with soreness to Rt arm to pneumonia vaccine. Also got a fever of 100.4. Pt called our office on 9/30 when symptoms resolved. Pt took MOTRIN and recovered.									Y	09/24/2009	09/24/2009	0		PUB	OTH						1						1	Injection site pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0359176	10/02/2009	NY	37.0	37		F	10/02/2009	Two or three minutes after getting the vaccine I felt dizzy, shortness of breath and fainted. The hospital emergency team assisted me with oxygen and on the Urgent Care Unit an EKG, and sugar tests were done.				Y					Y	09/30/2009	09/30/2009	0	Normal	PVT	UNK	No	No	No			1						1	Blood glucose normal; Dizziness; Dyspnoea; Electrocardiogram normal; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960322P~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359177	10/02/2009	ME	27.0	27		F	10/02/2009	Injection site local reaction. Raised, warm red area 6 1/2 cm x 3 1/2 cm.									Y	09/30/2009	10/01/2009	1		PUB	UNK	LIALDA	None	None	Local inj site Rxn~Influenza (Seasonal) (no brand name)~UN~26.00~Patient		1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3214AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359178	10/02/2009	PA	27.0	27		F	09/30/2009	Pain, tenderness warmth @ site fever low grade 99.1. Right arm.										09/28/2009	09/29/2009	1		PUB	PVT						1						1	Injection site pain; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U3157AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~UF499AA~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~0031Y~UNK~UN~RA~TDAP (ADACEL)~1	USA		Influenza
0359179	10/02/2009	FL	62.0	62		F	10/02/2009	FEVER 103,TREMORS,WEAKNESS,FATIGUE,MACULAR RASH ON FACE,RASH AT VACCINE SITE ON LEFT DELTOID BEING OBLONG,ECCENTRICALLY LOCATED FROM THE INJECTION SITE-MEASURING 4CM X 4CM				Y					N	09/29/2009	09/29/2009	0		PVT	PVT	LOTREL,SYNTHROID,IMDUR ER,PLAVIX,ZETIA,NIASPAN,BENAZAPRIL,FLEXERIL,ACTONEL,TOPROL XL,LOVASTATIN	NO ACUTE ILLNESS AT TIME OF VACCINE	OSTEOPPENIA,HYPOTHYROISM,HYPERTENTION,CORONARY ARTERY DISEASE AND QUESTIONABLE DRUG INDUCED LUPUS IN PAST BUT NOT PRESENT AT TIME OF VACCINE			1						1	Asthenia; Fatigue; Injection site rash; Pyrexia; Rash; Rash macular; Tremor	FLU3~SANOFI PASTEUR~U3201AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359180	10/02/2009	MO		12		F	10/02/2009	this patient was given afluria which is only to be given to 18 and older. no reaction.  I-92579218 and I-92318744									Y	09/16/2009				UNK	UNK						1						1	Inappropriate schedule of drug administration	FLU3~CSL LIMITED~0584911A~2~ID~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359181	10/02/2009	MO		9		F	10/02/2009	this patient was given afluria which is only to be given to 18 and older. no reactions. I-92579278 and I-92318744									Y	09/16/2009				UNK	UNK						1						1	Inappropriate schedule of drug administration	FLU3~CSL LIMITED~0584911 A~2~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359182	10/02/2009	MA	9.0	9		F	10/02/2009	While waiting in observation room after shot was given, the observation room nurse noted a red circle at the vaccine injection site.  The child had removed a round sticker that she had placed over the bandaid at the injection site.  Hydrocortizone cream and ice were applied.  The child was refered to her pediatrician.  According to mother, after approximately 20 minutes, a red, blotchy rash appeared on both arms and across the chest.  The following day, the child complained of itchiness and was taken to the physician.  She was treated with double claritin and prednisone.				Y					Y	09/23/2009	09/23/2009	0		UNK	UNK	Claritin	sniffles, cough, no fever	none			1						1	Injection site erythema; Pruritus; Rash macular	FLU3~SANOFI PASTEUR~U3185AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359183	10/02/2009	MA	5.0	5		M	10/02/2009	No signs/symptoms of adverse reaction were observed in observation room on the day of the flu clinic.  Mother reports that patient developed a itchy red blotchy rash on his chest and back on September 27, 2009 at 3:00pm.  He was seen by his pediatrician and continued on claritin.				Y					Y	09/23/2009	09/27/2009	4		UNK	UNK	Claritin	sniffles, no fever	none			1						1	Rash; Rash erythematous; Rash macular; Rash pruritic	FLU3~SANOFI PASTEUR~U3185AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359184	10/02/2009	NJ	16.0	16		F	10/02/2009	Fluzone flu vaccine administered, as vaccine completed patient immediately developed a 6.5 x 5.5 cm flat round erythemic area with pruritis.  No respiratory distress.  O2 sat 100%.  Given Benadryl 50mg po and monitored.  Rash abated in 60 minutes.									Y	10/01/2009	10/01/2009	0		PVT	PVT	Singulair, flovent, Allegra, Astylin		Celiac, asthma, seasonal allergies			1						1	Immediate post-injection reaction; Injection site erythema; Injection site pruritus; Injection site rash; Oxygen saturation normal	FLU3~SANOFI PASTEUR~U3213AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359185	10/02/2009	MI	49.0	48		M	10/02/2009	Slight cough from 6:00 p.m. to 8:00 p.m.  09/29/09  Fever from 9:00 p.m. to 12:00 a.m. 09/29/09.  No treatment sought or taken.									Y	09/29/2009	09/29/2009	0		UNK	UNK						1						1	Cough; Pyrexia	FLU3~SANOFI PASTEUR~U3207AA~UNK~IJ~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359187	10/02/2009	TX	54.0	54		F	10/02/2009	localized area that is warm, swollen, and tender to touch									Y	09/29/2009	09/30/2009	1		PVT	PVT	Maxair, Restoril, Trilenelyn, Veramyst, Allegra, Midrin, Advair	none	history of asthma			1						1	Feeling hot; Local reaction; Local swelling; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98441p1a~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359188	10/02/2009	MA				F	10/02/2009	2 day later L -arm -deltoid generalized local reaction 9 cm x 6 cm - erythema - induration.									U					PUB	PVT	None	None	None			1						1	Erythema; Induration; Local reaction	FLUX~SANOFI PASTEUR~UT3125AA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359189	10/02/2009	VT	44.0	44		F	09/29/2009	Uncontrolled coughing, hoarseness, tongue started swelling, fever & chills, short of breath, red eyes; was seen in emergency dept at Rutland Regional Med Ctr & treated for allergic reaction.				Y					Y	09/24/2009	09/24/2009	0		PUB	PVT	Zyrtec	No illness	Sulfa -> hives	None~ ()~~0.00~Patient		1						1	Chills; Cough; Dysphonia; Dyspnoea; Emergency care; Hypersensitivity; Ocular hyperaemia; Pyrexia; Swollen tongue	FLU3~SANOFI PASTEUR~U3207AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359190	10/02/2009	WI	60.0	60		F	09/24/2009	Sore arm for greater than 2 1/2 wks, firm on palpation-arm appears swollen/larger on right than left on inspection in deltoid area.									N	09/08/2009	09/08/2009	0	Doppler-US upper arm is normal. No DVT or other abnormality seen.	PVT	OTH		None	None			1						1	Induration; Injection site swelling; Pain in extremity; Ultrasound Doppler normal	FLU3~SANOFI PASTEUR~U3178AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359193	10/02/2009	MD	2.0	2	.1	F	09/29/2009	3 days of fever in a 2 year old girl. Friday 9/18/09 10 AM, 3 vaccines administered: MMR, PENTACEL, FLUMIST. Sat. 9/19/09 12 noon thru end of day, fever started. Varied from 100-102 degrees. Treatment liquid TYLENOL-not effective (discontinued immediately), liquid MOTRIN-every 6 hours approx. Sun. 9/20/09 all day, fever persisted 100-102 degrees. Administered liquid MOTRIN. Mon. 9/21/09 all day until late PM, fever subsided late PM. MOTRIN discontinued late PM. Fri. 9/25/09 4:45 AM-7:00 PM, vomiting every 20-30 minutes. No medication given.									Y	09/18/2009	09/19/2009	1	None	PVT	PVT	None	None	None			1						1	Pyrexia; Vomiting	DTAPIPVHIB~SANOFI PASTEUR~~UNK~UN~UN~DTAP + IPV + HIB (PENTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~MERCK & CO. INC.~~1~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0359202	10/02/2009	TX	29.0	29		F	10/02/2009	localized area with redness, swelling, itching, and warm to touch									Y	09/30/2009	10/01/2009	1		PVT	UNK	lisinopril HCT	none		redness, itching, warm to touch~Influenza (Seasonal) (Fluvirin)~1~28.00~In Patient		1						1	Erythema; Local reaction; Pruritus; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98441p1a~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359203	10/02/2009	TX	40.0	40		F	10/02/2009	localized area of swelling, warmth, and tenderness									Y	09/30/2009	10/01/2009	1		PVT	PVT	advil, multivitamin, Calcium D, Trimax, Cellulose, Fat blocker, essential fatty acids	none				1						1	Feeling hot; Local reaction; Local swelling; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98441P1A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359207	10/02/2009	NJ	3.0	3		F	10/02/2009	Received Influenza vaccine 9-30-09 at 7:30 pm on 10-1-09 at 5 pm child c/o to mom arm was sore mom noticed orange size erythema on upper arm.  Seen 10-2-09 Left upper arm with vesicles, large area of erythema and edema up to left shoulder and spreading down with streak toward left elbow, few scratch marks but unable to identify vaccine administration site.  Tender on palpation.				Y					U	09/30/2009	10/01/2009	1	referred to ER for IV antibiotics	PVT	PVT			RAD			1						1	Injection site erythema; Injection site oedema; Injection site pain; Injection site streaking; Injection site vesicles	FLU3~SANOFI PASTEUR~U3176CA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359208	10/02/2009	MN	44.0	44		F	10/02/2009	24 hours after administration of seasonal influenza (TIV) and pneumovax, patient developed myalgias, chills, fatigue and developed progressively worsening hives the subsequent 4 days with some subjective symptoms of chest and throat tightness.  She saw her primary care doctor 2x and myself (allergist) 1x for these symptoms				Y					Y	09/26/2009				UNK	UNK	Prozac, Nexium, Aspirin	None	multiple sclerosis			1						1	Chest discomfort; Chills; Fatigue; Myalgia; Throat tightness; Urticaria	FLU3~SANOFI PASTEUR~U3178AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0037Y~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0359209	10/02/2009	MI	51.0	51		F	10/02/2009	Woke up in mmring not feeling well, had a headache, felt warm and dizzy.Had to leave work.Second day, still not feeling good, headach and sorethroat.									U	09/30/2009	10/01/2009	1		UNK	PVT			none			1						1	Dizziness; Feeling hot; Headache; Malaise; Oropharyngeal pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~000000000000000~2~~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0359210	10/02/2009	CA	86.0	86		M	10/02/2009	Patient came in on Sept 25th in morning to show a bruise about 1-2 inches in diameter which could have been the site of the shot. The bruise was begining to fade specially at the edges. The patient said that it did not hurt and did not have any other adverse effects. I suggested that he contact his doctor.									U	09/17/2009	09/17/2009	0		OTH	OTH	Benicar, Furosamide, KCl, Terazosin, L-thyrozine					1						1	Injection site haematoma	FLU3~SANOFI PASTEUR~U3190AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359211	10/02/2009	MI	34.0	34		F	10/02/2009	About 4 hours after injection, I had severe body aches, neck pain, headache, nausea, mild fever, chills and burning in my nose.  This lasted for approximately 18 hours.  I am an employee at Hospital in the emergency room and received it there.									Y	09/16/2009	09/16/2009	0		UNK	UNK		None	Compazine, Omnicef			1						1	Chills; Headache; Nasal discomfort; Nausea; Neck pain; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~113204AA~7+~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359212	10/02/2009	WI	14.0	14		F	10/02/2009	Pt began with Abdominal /trunk spasms on 9/18/09 AM, persistant, uncontrollable per pt, fully alert, no past history of spasms or seizures, no fever or illness. Admitted 9/19-24/09 to Hospital due to symptoms as below. Note also had a few spasm night of 9/24, used Benadryl and clonapin as per neurology, few more 9/25/09 AM. stopped Clonapin as did not seem related to stopping and made drowsy per family.  No more myoclonus since when seen at clinic on 9/30/09. Discharge Diagnoses : Spinal myoclonus of unknown etiology / Possible conversion reaction  (note family disagrees with conversion reaction as etiology). Depression treated with Zoloft. Hospital Management: Basics: labs (urine HCG, urinalysis, urine tox screen, electrolytes, thyroid studies, anti-strep O, anti-mycoplasma antibodies, anti-lyme antibodies, ammonia, ANA screen, free metanephrines, ESR, CRP). Special Medications: Clonazepam, valium, one dose Valproate. Imaging: MRI of brain/spine   Consults: Neurology, Physical Therapy, Psychiatry and Health Psychology. Anesthesia: conscious sedation. Special Monitoring: video EEG monitoring 10/26/09:  Hospital records received for dates of service 9/18/09 to 9/19/09 and 9/19/09 to 9/24/09.  Dx:  Spinal myoclonus vs. conversion reaction.  Assessment:  Presents with repetitive spasm of head, arms, neck, legs and trunk.  Not painful, but impaired ADL's.  No alteration in consciousness.  Also c/o slight nausea, denies headache,  some dizziness, had a few bouts of diarrhea on 9/19.  Spasms are myoclonic in nature, and tend to resolve while she is asleep.  Gait slightly unsteady. Romberg Positive.  Upon admission on 9/19 presented with myoclonus of abdominal musculature. Able to talk and text during episodes.  Started on Depakene.  Differential dx's. include infectious or post-infectious, autoimmune, paraneoplastic, or structural (mass) or idiopathic. Exhibits no seizure activity.  Clonazepam seemed to decrease frequency of myoclonic jerks.  Zoloft discontinued, known to cause myoclonus in peds. population. PT was initiated then haulted as there was no evidence of LE weakness.   Discharged to home, slightly improved to follow up with Peds, Psych and Neurology.					Y	6			Y	09/16/2009	09/18/2009	2	Hospital Management: Basics: labs (urine HCG, urinalysis, urine tox screen, electrolytes, thyroid studies, anti-strep O, anti-mycoplasma antibodies, anti-lyme antibodies, ammonia, ANA screen, free metanephrines, ESR, CRP) Special Medications: Clonazepam, valium, one dose Valproate Imaging: MRI of brain/spine   Consults: Neurology, Physical Therapy, Psychiatry and Health Psychology Anesthesia: conscious sedation Special Monitoring: video EEG monitoring 10/26/09:  Hospital records received for dates of service 9/18/09 to 9/19/09 and 9/19/09 to 9/24/09.   Labs and Diagnostics:  Chloride 107 (H), CO2 21 (L), CRP 0 (NL), UA Bacteria-present (H), UA WBC 01 (H). Positive Romberg.  video EEG-no myoclonic events.	UNK	UNK	Had been on Zoloft approx 3 weeks before spams for depression.  Stopped at admission. Had been on zoloft for 1 year before without symptoms- had stopped over summer and restarted 8/09.	None	Depression; Mild asthma; Dysfunctional uterine bleeding.  10/26/09:  Hospital records received for dates of service 9/18/09 to 9/19/09 and 9/19/09 to 9/24/09. PMH:  Anxiety disorder, depression, essential tremor, much different than currently, Headache, Hiatal hernia, Gallbladder removal, allergy to nickel, NKDA.			1						1	Abdominal rigidity; Ammonia; Antibody test; Antinuclear antibody; Blood electrolytes; Borrelia burgdorferi serology; C-reactive protein; Depression; Drug screen; Electroencephalogram; Laboratory test; Muscle spasms; Mycoplasma serology; Myoclonus; Nuclear magnetic resonance imaging; Nuclear magnetic resonance imaging brain; Red blood cell sedimentation rate; Streptococcal identification test; Thyroid function test; Urine analysis; Urine human chorionic gonadotropin	FLUX~SANOFI PASTEUR~U3177AA~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0359213	10/02/2009	KS	42.0	42		F	10/02/2009	Bruise and soreness, burning at site. Red raised rash ranging from size of tip of eraser to dime sized, bilateral scapula area to hip area down her back only on sides. Denies itching. Rash was not warm to touch. Afebrile.									Y	10/01/2009	10/01/2009	0	None	PUB	PVT	Denied new medications.	None	Unknown			1						1	Injection site haematoma; Injection site pain; Rash maculo-papular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA476AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0359214	10/02/2009	NY	38.0	38		M	10/02/2009	red painful rash on left arm several hours after vaccine									U	09/30/2009	09/30/2009	0		UNK	UNK		none	excema			1						1	Pain in extremity; Rash erythematous	FLU3~GLAXOSMITHKLINE BIOLOGICALS~afllla275aa~7+~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0359215	10/02/2009	MI	28.0	28		F	10/02/2009	Patient received vaccine in deltoid muscle on 9/29/09.  Later that evening noticed fatigue and malaise.  When patient woke in the morning, pt noticed itchy blisters on chest and abdomen.  She started taking tylenol after noticing the blisters.  On 10/1/09 patients presented to clinic with vesicles on her chest and abdomen.  No other complaints were noted.  Lot Number: U3197AB									U	09/29/2009	10/01/2009	2		PUB	UNK	PNV24-Iron Cbn&Gluc-FA-DSS-DHA Oral (Pre-Natal Vitamin)	Pregnancy Check-up				1						1	Blister; Fatigue; Malaise; Pruritus	FLU3~SANOFI PASTEUR~U3197AB~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359216	10/02/2009	AL	54.0	54		F	10/02/2009	Pneumonia Vaccine given around 11:00am, 09/25/09. Pt reports nausea and vomiting, diarrhea, temp. 103 beginning around 6:00pm on the same day. Small amount of redness at site (Left arm). Symptoms progressively worsened, and admitted to Hospital on 9/27/09, which by this time Left arm was red, swollen and diagnosed with Cellulitis. Dismissed from hospital on 9/30/09. 10/5/09 DC summary and hospital records received from dates, 9/28/09 to 9/30/09. DC DX: Cellulitis of LUE. Systemic inflammatory response syndrome. Intravascular depletion with hypovolemic hyponatremia. Marked bandemia. Acute normocytic anemia probably r/t sepsis. Hypoalbuminemia, hypokalemia secondary to diarrhea. Presenting symptoms: Arriving to ER with high fever, systemic inflammatory response syndrome with severe diarrhea, dehydration, hypokalemia. 2 days prior received pneumovax in LUE with subsequent nausea/vomiting, pain, induration, erythema of entire left deltoid spreading to bicep region site of injection. Recieved steriod tx in ER with relief. After 24-36 hours localized symptoms returned. TX: IV Abx, after 24 hours bandemia resolved overall pt improvement.					Y	3			Y	09/25/2009	09/25/2009	0	Reportedly, H1N1 flu test Negative. Reports WBC were elevated. 10/5/09 DC summary and hospital records received from dates, 9/28/09 to 9/30/09.Diagnostics/Labs: CXR normal, Xray left humerus normal, EKG normal, WBC 18(H), Neutrophils 49(H), Bands 35%(H), K+ 3(L), Chemistry(+) dehydration. RBC 4.01(L), HGB 12.4(L), HCT 36(L), HGB A1-C 6.3(H), blood/urine culture(-), Influenza A(-).	UNK	UNK	Symbicort BID	None	Reactive Airways Dysfunction Syndrome 10/5/09 DC summary and hospital records received from dates, 9/28/09 to 9/30/09. PMH: Morbid obesity, reactive airway disease secondary to toxic fume exposure, hypoglycemia with suspect NIDDM type 2.			1						1	Body temperature increased; Diarrhoea; Erythema; Influenza serology negative; Injection site erythema; Nausea; Oedema peripheral; Vomiting	FLU3~SANOFI PASTEUR~U3191AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0627Y~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0359218	10/02/2009	NY	52.0	52		F	10/02/2009	Patient experienced a fever, chills, paleness, a swollen and red arm that achieved the size of a baseball.  She did not seek medical attention and did not verify her temperature.									U	09/30/2009	09/30/2009	0		UNK	UNK		unknown	none			1						1	Chills; Erythema; Oedema peripheral; Pallor; Pyrexia	FLU3~SANOFI PASTEUR~u3192aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0627y~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359219	10/02/2009	TX	64.0	64		F	10/02/2009	PT GIVE ZOSTAVAX ON 9/8/09, VISITED DR WITH RASH ON 9/11/09, CONFIRMED SHINGLES ON 9/14/09.				Y					Y	09/08/2009	09/11/2009	3	LAB TEST CONFIRMED SHINGLES	UNK	PVT						1						1	Herpes zoster; Laboratory test abnormal; Rash	FLU3~SANOFI PASTEUR~U3177AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0112Y~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~1554X~1~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0359220	10/02/2009	ID	49.0	49		F	10/02/2009	Patient stated that within a few hours of receiving the vaccine she developed mild cold like symptoms.  She stated she did not ever have a fever but did have a sore throat, congestion, tiredness and burning in both eyes - the burning was from the inside out and lasted several days. The patient stated that the cold symptoms got worse after about 2 weeks.  The patient stated that about the same time that the cold symptoms got worse she began to develop nerve pain when biting down.  She stated this symptom only lasted for about 3 days.  She described the pain as when I would bite down I felt a sharp shooting pain clear up into my left eye. The patient stated she has had shingles x 2 in the past which she describes were along the nerves across the top of the left side of the top of her head.  The patient is unclear if the vaccine perhaps caused some nerve irritation or perhaps she was predisposed to nerve irritation because of her history.  The patient stated all of her symptoms including the nerve pain have resolved completely without residual but she is wondering if she should ever get the Flumist vaccine again.									Y	09/11/2009	09/11/2009	0		PVT	PVT	Unknown	No	history of shingles x 2			1						1	Eye irritation; Fatigue; Nasopharyngitis; Neuralgia; Oropharyngeal pain; Pain; Respiratory tract congestion	FLUN3~MEDIMMUNE VACCINES, INC.~500695P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0359221	10/02/2009	KY	64.0	64		F	10/02/2009	Pt left clinic 15 min. after administration of vaccine. Pt returned to clinic 5 min later with complaints of shortness of breath. Pt placed on oxygen and given Benadryl 50mg/ml per protocol. Then was transported via ambulance to hospital. Pt was given more Benadryl upon arrival. Was also given Prednisone while in ER. Pt was sent home with Prednisone pack x 1wk.				Y					Y	09/21/2009	09/21/2009	0	EKG, CXR, blood work	UNK	UNK	unknown	None	Alergy to PCN and Percocet. No other known history.			1						1	Blood test; Chest X-ray; Dyspnoea; Electrocardiogram	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA468BA~3~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0627Y~1~SC~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~UF486DA~3~IM~RA~TDAP (ADACEL)~1|VARZOS~MERCK & CO. INC.~0791Y~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0359222	10/02/2009	MA	5.0	5		F	10/02/2009	Patient received influenza vaccine IM in left arm on 09/30/09.  Parent noted redness on left upper arm on 10/02/09.  Seen in office 10/02/09 with large area of redness and tenderness involving 90% of anterior upper left arm.				Y						09/30/2009	10/02/2009	2		PVT	PUB	Poly-Vi-Fluor		Allergy to Amoxicillin and Ibuprofen			1						1	Injection site erythema; Injection site pain	FLU3~SANOFI PASTEUR~U3196AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359223	10/02/2009	MI	58.0	58		F	10/02/2009	I received the flu shot at 4 p.m. on wednesday, sept. 30.  I was ill at 3 a.m. with a severe stomach ache.  By afternoon on the 1st of oct., it then turned into full body aches, 100 degree fever, headache, and chills. At 6 a.m. on Oct. 2 the fever broke, and I was left with a headache, and body aches									Y	09/30/2009	10/01/2009	1		PUB	PVT						1						1	Abdominal pain upper; Chills; Headache; Malaise; Pain; Pyrexia	FLUX~SANOFI PASTEUR~~UNK~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359224	10/02/2009	KS	42.0	42		F	10/02/2009	Approximately 4 days after adminstration of the vaccine, the patient developed an area of erythema measuring 5cm. Clear fluid was observed draining from the site close to the adminstration site. There was no focal abcess formation. The patient, an employee of this hospital, was seen by our emergency department staff. The fluid was drained, antibiotic ointment applied and covered with a dry dressing.  No further treatment is anticipated.				Y					Y	02/22/2009	02/26/2009	4	A bacterial culture of the clear exudate has been ordered.	UNK	UNK	No other medications	NA	NA			1						1	Bacterial culture; Erythema; Injection site discharge	FLU3~CSL LIMITED~06449111A~3~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0359225	10/02/2009	NJ	70.0	70		U	10/02/2009	difficulty breathing, tightness in chest, rapid and skipped heart beats, paleness, excessive urination,feeling of choking,dizziness				Y					U	09/28/2009	09/28/2009	0	possible flu shot reaction	UNK	UNK		none	healed ulcer			1						1	Chest discomfort; Choking sensation; Dizziness; Dyspnoea; Extrasystoles; Heart rate increased; Pallor; Pollakiuria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~ndc66521-0112-1~5~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359226	10/02/2009	TN	23.0	23		M	10/02/2009	Patient developed itching and rash on vaccination arm within 5 minutes of the shot. He has no known allergies.No previous reactions to vaccinations. The rash and itching intensified over the next 30 minutes. Benadryl was given (50mg) orally at 35  minutes post shot. Paramedics were called and arrived 5 minutes after giving benadryl. Patient's was stable, BP was high but patient refused to be taken to hospital.									U	10/02/2009	10/02/2009	0		UNK	UNK	Ibuprofen, nicotine,aspirin		asthma			1						1	No reaction on previous exposure to drug; Pruritus; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838p1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359228	10/02/2009	PA	13.0	13		M	10/02/2009	Inactivated Influenza Vaccine 0.5ml administered to patient intramuscularly into left arm using 1 needle. Initially patient appeared fine. His 2 siblings also received their flu vaccines and his sister was seen by physician. About 5 minutes later, the family was leaving the exam room and standing in the hallway when patient appeared dazed and fell to the floor, unresponsive for 5-10 seconds. He initially had 1 twitching movement of his head after falling to the floor but no seizure activity. Regained consciousness in 5-10sec. Responsive and oriented. Appeared pale and felt dizzy. Recovered after ~ 10minutes of rest, intake of water, and candy. Sibling also developed lightheadedness, pallor after seeing patient lose consciousness. Sibling did not lose consciousness, recovered with rest, intake of water.									Y	10/02/2009	10/02/2009	0	BP 117/65 taken while patient was laying on the floor after regaining consciousness. Heartrate 55-76. EKG was done, normal reading.	UNK	UNK		No	None			1						1	Blood pressure normal; Dizziness; Electrocardiogram normal; Fall; Feeling abnormal; Heart rate decreased; Loss of consciousness; Muscle twitching; Pallor; Unresponsive to stimuli	FLU3~SANOFI PASTEUR~U3174EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359230	10/02/2009	UT	56.0	56		M	10/02/2009	Pt developed itching in hands and feet approx 36 hrs after flu vaccine adminitration. These progressed to hives and pt also had a dry cough/chest pain10/16/2009 received hospital records for 10/2-10/3/2009. Patient reporting sx 4 days post vaccine of itching, rash, welts, swelling in fingers and arthralgias. Tx: IV Solu Medrol, IV Benadryl and IV Famotidine. DC DX urticaria.				Y	Y	1			Y	09/29/2009	10/01/2009	2	Lab: CBC, ESR, CMP WNL Xrays: None	UNK	UNK	clopidogrel, aspirin, simvastatin, Hyzaar, metoprolol, Fish oil	none	NKDA, CAD PMH: CAD, Dyslipidemia Allergies: NKDA none			1						1	Chest pain; Cough; Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua448ba~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0359231	10/02/2009	MI	27.0	27		F	10/02/2009	Flu symptoms: fever, aches, congestion, runny nose, sore throat, symptoms persisted for 7 days. Vaccine caused what it was meant to prevent.									Y	09/26/2009	09/27/2009	1		PUB	PVT	the pill, birth control.	None	Had severe pneumonia 9/2008, one year prior to vaccination			1						1	Influenza; Oropharyngeal pain; Pain; Pyrexia; Rhinorrhoea; Upper respiratory tract congestion	FLUX~UNKNOWN MANUFACTURER~~2~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359268	10/02/2009	IN	29.0	29		F	10/02/2009	This case was reported by a consumer (also the subject) and described the occurrence of miscarriage in a 29-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included Bactrim allergy of rash or hives. The subject had not previously received influenza vaccine. She had not experienced adverse events following previous vaccinations. Concurrent medications included Prenatal vitamins. On 25 August 2009 at 10:00 the subject received 1st dose of FLULAVAL (0.5 ml, unknown route) when she was 8 weeks pregnant. On 25 September 2009, 31 days after vaccination with FLULAVAL, the subject experienced miscarriage. The subject went for a routine check up on 25 September 2009 and no heart beat could be found. Ultrasound determined that the subject had miscarried twins at approximately 8 weeks. This case was assessed as medically serious by GSK. The subject was treated with dilatation and curettage as a same day surgical procedure at the hospital.				Y					U	08/25/2009	09/25/2009	31	25 September 2009: Ultrasound revealed the subject had miscarried twins at approximately 8 weeks.	PVT	OTH	Prenatal vitamins (Potassium iodide + Potassium sulphate + Calcium salt + Phosphorus salt + Vitamin A + Ascorbic acid + Niacinamide + Thiamine hydrochloride + Riboflavine + Vitamin D + Manganese salt + Iron salt + Cobalt sulphate + Magnesiu	Unknown	Bactrim Allergy; The subject had not previously received influenza vaccine. She had not experienced adverse events following previous vaccinations.		A0809839A	1						1	Abortion spontaneous; Drug exposure during pregnancy; Ultrasound scan abnormal; Uterine dilation and curettage	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA259AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0359272	10/02/2009	NJ	33.0	33		F	10/01/2009	Positive vomiting, nausea, back pain, evanescent dysesthesias, positive blurry vision, shortness of breath and facial weakness - Tx. Plasmapheresis - 9/30, 10/1.10/20/09-records received for dates of service 9/27/28/09C/O numbness in face, arms, back and belly, vomiting, headache, blurry vision and shortness of breath along with decreased taste, diaphoresis. 9/28/09 worsening numbness, continued nausea and vomiting, left flank pain, severe fatigue. Consultation, continues with facial weakness and respiratory distress, and desaturation to 78%,intubated with abnormal arterial blood gas pH of 7.11, and respiratory failure, hyponatremia and hyperkalemia, multiple electrolyte abnormalities, new onset of bruising. 10/29/2009 Consult records and Lab and Dx studies from Inpatient stay 9/27/2009-10/16/2009. Patient with c/o's facial numbness, tingling in extremities, Neuro exam noted dec DTR's, dec sensation pinprick, temperature. EMG anormal with Dx of GBS. Tx: intubated for resp distress, IVF, IV ABX, C-section done.  12/09/09 DC summary for DOS 09/27/09  10/16/09. Final DX:  GBS.  Pt c/o generalized weakness, back pain, L flank pain, chest pain, SOB, changes in taste and sensation, diaphoresis, headaches, insomnia, facial weakness. On examination: Pt lethargic, worsening of weakness, lost bladder function. On 09/29/09, Pt tachypneic, SOB, anxiety, low oxygen saturation. Emergent intubation initiated. Pt transferred to ICU. Pt developed metabolic acidosis with hyponatremia and hyperkalemia.  On the same date, Pt underwent an emergent C section due to decelerating fetal heart beat and delivered a viable baby. Tx: plasmapheresis. Pt's respiratory status and weakness improved.  Pt discharged to a rehab center.          ICD-9 codes: 648.91, 518.81, 357.0, 358.0, 507, 446.6, 276.7, 276.1, 276.2, 788.30, 648.41, 670.22, 300.4, 296.90, 306.9, 659.71, 647.91, v270, v025.1, 356.9					Y	19			U	09/15/2009	09/26/2009	11	ARDS 10/20/09-records received-WBC 21,000, hemoglobin 8.5, hematocrit 25, mononucleosis negative, serum actone level positive, ESR 41, protein C125 cortisollevels 69 low adrenal insufficiency, EDD 11/2/09 34 weeks gestation LP increased protein. Labs:  VDRL, RPR non-reactive, FV Leiden neg, C3 low, Streptococcal antigen neg,  RHI viral testing neg, CBC: WBC hugh, Hgb and Hct low, Platelets high, Bands high, Neutrophils high, Rbc morphology abnormal, Serun acetone +, Blood ,urine and stool cultures neg, CSF Protein 114 high, CSF culture neg, CMV neg, Neutrophil Cytoplasmic antibody neg, Anticardiolipin profile neg, BMP: Na low, K and LDH high, Urine ketones high, Bronchial washing gm + cocci,urine drug screen + for benzodiazepines Dx studies: MRI/MRA Brain, Ct Abdomen, Abd US, MRI L-spine all normal, Doppler studies LE's neg for DVT, EMG noted severe sensorimotor demyelinating neuropathy of RUE and RLE consistent with Dx of GBS  DX studies: O2 saturation: high 70s; CXR: acute respiratory distress syndrome; ABGs, MRI, CT, EMG: demyalinating process and lumbar puncture: confirmed GBS.	PVT	UNK	Vancomycin; ZOSYN; Azithromycin; FLAGYL	Pregnancy	10/20/09-records received-PMH: depression. Anorexia in teen, mood disturbances, anxiety. Miscarriage. Elective termination of pregnancy. PMH: Anxiety, depression. Vaccine exposure during pregnancy. Allergies: NKDA			1						1	Acute respiratory distress syndrome; Back pain; Dysaesthesia; Dyspnoea; Facial paresis; Nausea; Plasmapheresis; Vision blurred; Vomiting; Drug exposure during pregnancy; Electromyogram abnormal; Guillain-Barre syndrome; Life support; Lumbar puncture abnormal; Premature labour	FLU3~SANOFI PASTEUR~U3184AA~UNK~IJ~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U3184A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0359273	10/02/2009	CT	10.0	10		M	10/02/2009	Neck pain, leg weakness, (R) arm pain, ataxic gait, worsening over 2 days. -> Bell's palsy.  11/17/09 ED, hospital records, hospital and rehab discharge summaries received service dates 9/24/09 to 10/26/09. Assessment: Guillain-Barre Syndrome Patient with URI symptoms onset 1 week ago, seen by PCP for otitis, followed by malaise, cough, nausea, vomiting. Lower extremity ataxia and numbness, right upper arm pain. Ataxic gait, right sided facial droop and ptosis. Weak patellar reflexes bilaterally. Pain with downward gaze. Headache. Generalized back pain over spine on palpation. Unable to walk. IVIG administration. Discharged - to continue outpatient OT/PT.					Y	32				09/02/2009	09/23/2009	21	Lumbar puncture; Nerve conduction test (+); increased protein.  11/17/09 ED, hospital records, hospital and rehab discharge summaries received service dates 9/24/09 to 10/26/09. LABS and DIAGNOSTICS: CSF - RBC 7 (H) WBC 1 cells/uL Glucose 64  mg/dl Protein 124 mg/dl (H). CBC - WBC 9.1 10^9L Platelets 613 10^9L (H) HGB 14.6 g/dl HCT 42.2% Gran 66%. CHEM - Calcium 9.9 mg/dl CK 29 U/L (L) Cl 99 mEq/L Bicarb 26 mEq/L Creatine 0.4 mg/dl Glucose 99 mg/dl Potassium 4 mEq/L Magnesium 2.1 mEq/L (L) Sodium 136 mEq/L Phosphorus 4.8 mg/dl. EMG - Abnormal, consistent with Guillain-Barre.	PVT	UNK		None	Asthma. 11/17/09 ED, hospital records, hospital and rehab discharge summaries received service dates 9/24/09 to 10/26/09. Asthma, febrile seizures, RSV. Bee sting - anaphylaxis. Sulfa drugs - rash.		CT200914	1						1	Ataxia; CSF protein increased; Facial palsy; Lumbar puncture; Muscular weakness; Neck pain; Nerve conduction studies abnormal; Pain in extremity	FLU3~SANOFI PASTEUR~U3259EA~6~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0359274	10/02/2009	AL	22.0	22		F	10/02/2009	Late PM after receiving injection around 11:45 AM of the same day, hands itching/red/burning/rash-macular. Woke at 4 AM with burning/itching-No meds to tx-Returned to clinic at 8 AM given ZYRTEC 10 mg, TRIAMCINOLOE 0.1% cream to use BID.									N	10/01/2009	10/01/2009	0	Dx strep on 9/23-completed AMOXIL on 10-1	OTH	PVT	ORTHO TRI-CYCLEN; AMOXIL; ZOLOFT	Group A strep	Depression			1						1	Erythema; Pruritus; Rash macular; Skin burning sensation; Streptococcal infection	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA262AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0359276	10/02/2009	GA	9.0	9		F	10/02/2009	Approximately one hour after administering a flu vaccine. Child began to feel nauseated and became very pale. Two nurses on the scene noted that child's heart rate was irregular. Child had been to PE after receiving flu vaccine.									Y	10/01/2009	10/01/2009	0	BP - 160/100, Resp. 16, Blood sugar 107, O2 Sat 99% after 5 mins. 140/80 Resp. 16 (No shortness of breath).	OTH	UNK	None	Recovered from flu 2 weeks prior.	None			1						1	Blood glucose increased; Heart rate irregular; Nausea; Pallor	FLU3~SANOFI PASTEUR~U3174FA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359277	10/02/2009	CT	49.0	49		F	10/02/2009	Patient has extreme tenderness and redness in the form of an arm band around the injection site. Also complained of heavy or numb arm. Recomm ice, BEDRYL and monitoring									U	10/01/2009	10/01/2009	0		OTH	PUB		None	Unknown-CLINDAMYICIN Allergy reported 10/2/09			1						1	Hypoaesthesia; Injection site erythema; Injection site pain; Sensation of heaviness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848P1B~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359283	10/02/2009	MI	74.0	74		M	10/02/2009	Office visit 9/25/09 - localized, inflammatory 10 x 20 cm area of redness.									Y	09/23/2009	09/24/2009	1	None	PVT	PVT		None	None			1						1	Erythema; Inflammation; Local reaction	FLU3~SANOFI PASTEUR~43199AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0625Y~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359288	10/02/2009	CA	69.0	69		M	10/02/2009	Swelling, rash about 5 below injection site.				Y					N	09/28/2009	09/29/2009	1	None	OTH	PUB		None	Hypertension			1						1	Injection site rash; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97843P2~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0632Y~2~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0359290	10/02/2009	CA	54.0	54		F	10/02/2009	Noticed slight pain, redness + swelling that same evening Dx cellulitis Rx for KEFLEX.									Y	09/30/2009	09/30/2009	0		PVT	UNK						1						1	Cellulitis; Erythema; Pain; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA468AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0359298	10/02/2009	SC	80.0	80		M	10/03/2009	Patients letter states: day after injection given, injection site very sore. 4 days after injection, shoulder and upper arm became painful and stiff. 6 days later there was discoloration of area around left elbow including lower and upper forearm. Went to Dr. on Sept. 16 and believes the injection caused a hemorrhage that still pains him as of Sept. 24.										09/03/2009	09/04/2009	1		OTH	PUB			Type II Diabetes; CHD; BPH; GERD and hypertension			1						1	Injection site haemorrhage; Injection site pain; Musculoskeletal pain; Musculoskeletal stiffness; Skin discolouration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960305P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359301	10/02/2009	CA	51.0	51		F	10/02/2009	9/25/09 16:35 within 30 minutes left outer eye felt heavy and was itching. Spoke to person who stated this was one of the reactions to AFLURIA vaccine. I spoke to Dr. who stated, no concern. Color will go from red->blue->red last 3 weeks. It is a glaucoma hemorrhage. One hour later started with right and left deltoid pain 0-10 5 lasted 2 days. PCM Dr. have not seen provider or received treatment for symptoms only verbal advice. No longer have R/L deltoid pain but concerned about L red eye. Spot under iris in white area (sclera). Patient notified to follow up with provider for care. Patient agreed and understood.									N	09/25/2009	10/02/2009	7		MIL	MIL		L eye hemorrhage, R/L deltoid pain		~ ()~1~0.00~Patient		1						1	Asthenopia; Eye haemorrhage; Eye pruritus; Glaucoma; Immunisation reaction; Injection site pain; Ocular hyperaemia; Pain in extremity; Scleral discolouration	FLU3~CSL LIMITED~01649211A~1~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359302	10/02/2009	CA	41.0	41		F	09/25/2009	Pt c/o R lower back pain radiating on R buttock 10 min after pt received the pt received the influenza vaccine. Pt also c/o both eyes red  when she got home. No pain, no itching.									Y	09/24/2009	09/24/2009	0		MIL	MIL		None	None			1						1	Back pain; Musculoskeletal pain; Ocular hyperaemia	FLU3~CSL LIMITED~0724911A~1~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359303	10/02/2009	CA	20.0	20		F	09/25/2009	Pt c/o swollen both hands and feet when she woke up this morning. Burning sensation, fingers stiff with pain, redness noted.										09/24/2009	09/25/2009	1		UNK	UNK						1						1	Burning sensation; Erythema; Musculoskeletal stiffness; Oedema peripheral	FLU3~CSL LIMITED~01649211A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359304	10/02/2009	CA	55.0	55		F	10/01/2009	Pt stated after receiving FLUMIST, started to c/o sinus pain, chills, itchy eyes + stated feels something in my chest, cannot explain what it is. Pt still has this symptoms at this time.										09/27/2009	09/27/2009	0		MIL	UNK						1						1	Chest discomfort; Chills; Eye pruritus; Sinus headache	FLUN3~MEDIMMUNE VACCINES, INC.~500719P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0359306	10/02/2009	IL	22.0	22		F	10/02/2009	Post injection employee c/o pain and tingling. Upon evaluation site was warm and swollen. Site iced for a few minutes. Employee was offered ouside tx and declined. Employee was informed if symptoms persist or worsen to let manager or medical staff know.									Y	10/02/2009	10/02/2009	0	None	OTH	PVT	None	None	Mitral valve regurgitation/ heart murmur (sistole)			1						1	Injection site swelling; Injection site warmth; Pain; Paraesthesia	FLU3~CSL LIMITED~67849111A~1~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359307	10/02/2009	TX	49.0	49		U		Swelling of site injection for FLUVIRIN and PNEUMOVAX injection. Site warm to touch and fever over 102 degrees. Patient took TYLENOL, BENADRYL and cold compress to area.									N	09/28/2009	09/28/2009	0		PUB	OTH		None	None			1						1	Injection site swelling; Injection site warmth; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0037y~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359308	10/02/2009	MN	96.0	96		F	10/02/2009	Hives, Redness on hands, swelling of mouth. Anxiety.				Y					Y	09/17/2009	09/17/2009	0	None	OTH	PUB	POTASSIUM, SYNTHROID, LACTULOSE, NITROGLYCERIN, BUMEX, LORTA, LAXIX, LOPRESSOR, HYDROCORTISONE, ALBUTEROL SULFATE, THERMOTABS, NITROGLYCERIN TRANSDERMAL PATCH, COUMADIN, NITROGLYCERIN SUBLINGUAL TABLET, LISINOPRIL, IMDUR, ZETIA, CALCIUM, MU	None	ULTRAM			1						1	Anxiety; Erythema; Oedema mouth; Urticaria	FLU3~SANOFI PASTEUR~U3201AA~4~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359309	10/02/2009	CA	1.0	1	.0	M	10/02/2009	Fever 101 degrees (ax) on 10/1/09 while at day care in the afternoon with sl. lethargy; called office at 3:45 PM to report fever, recommended treatment with TYLENOL/fluids supportive treatment with appt if pt acting ill with decreased fever. At 4:40 parent called to report pt had seizure/paramedics transporting to local ER.  10/02/09 Seen in office and follow up to ER visit for febrile seizure.  IMP:  s/p Febrile Seizure, Rhinitis/Fever, s/p MMR and VARIVAX.  10/5/09 D.V. IMP:  URI;  h/o febrile seizure.  10/6/09 D.V. IMP:  Cough, Recurrent fever, Rhinitis, Fussiness.				Y						09/30/2009	10/01/2009	1	See attached labs	PVT	PVT		Sl. cough from cold/wk prior	GERD; eczema			1						1	Alanine aminotransferase increased; Aspartate aminotransferase increased; Convulsion; Emergency care; Laboratory test abnormal; Lethargy; Mean cell haemoglobin decreased; Pyrexia	FLU3~SANOFI PASTEUR~U3262EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0825Y~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0974Y~1~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0359310	10/02/2009	IL	62.0	62		M	10/02/2009	Patient was injected 2nd time due to not being able to provide 1st injection when needle removed patient developed hardening of skin about dime size, Checked on patient 10/02/09 and hardening was gone.									Y	10/01/2009	10/01/2009	0		OTH	OTH	None	None	None			1						1	Injection site induration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359311	10/02/2009	MN	2.0	2	.4	F	09/28/2009	Pt had onset of rash symptoms after receiving vaccine. Appeared as light pink tiny dots, then filled in more completely as red, slightly raised. Initially on trunk, arms and legs. Did present on face (day#2). Administered BENADRYL otc x3. Cleared slowly as of 9/27/09. No fever. No itching noted. Rash was noted 5-10 min after, increased by p.m.  More significant next day.									Y	09/24/2009	09/24/2009	0	None	PUB	PUB		None	None			1						1	Rash papular	FLUN3~MEDIMMUNE VACCINES, INC.~500688P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0359312	10/02/2009	CT	19.0	19		F	09/21/2009	Temp > 103 24 hours post vaccine chills, leg pains and weakness; skin painful, mild HA. Ruled local reaction. Rx TYLENOL. Sms persisted 24 hrs.									Y	09/18/2009				PVT	PVT	PROZAC	None	Multiple allergies; AMOXIL; ROCEPHIN	Encephalitis~Varicella (no brand name)~1~9.00~Patient		1						1	Body temperature increased; Chills; Headache; Local reaction; Muscular weakness; Pain in extremity; Pain of skin	FLU3~SANOFI PASTEUR~U132AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359317	10/02/2009	IN	56.0	56		F	10/02/2009	Large knot on upper arm, red, swollen, bruised, tender to the touch x 2 weeks. Syringe was made wit Latex.									Y	09/18/2009	09/18/2009	0		PUB	OTH			Latex, tape, All Atbx except CLINDOMYCIN			1						1	Injection site erythema; Injection site haematoma; Injection site mass; Injection site pain; Injection site swelling; Latex allergy	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA454BA~1~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0359318	10/02/2009	CA	11.0	11		M	09/30/2009	Pt developed pink macules/papules on chest - improved without interventions.									Y	09/30/2009	09/30/2009	0		PVT	PVT	None	URI (mild)	Autism; Obesity; Hypercholesterolemia			1						1	Rash erythematous; Rash maculo-papular	FLU3~SANOFI PASTEUR~U3212AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U28991AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C3249AA~1~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0359319	10/02/2009	WA	58.0	58		F	10/01/2009	Pt developed rash on back, neck, midsection and lots of itching. Took BENADRYL and went to the doctor.				Y					Y	09/30/2009	09/30/2009	0		OTH	PUB		None	None			1						1	Pruritus; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848P1A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359320	10/02/2009	KS	53.0	53		F	10/02/2009	Patient called pharmacy and said her arm was red and swollen around where she got her shot. She also said her arm hurt.									U	10/01/2009	10/01/2009	0		OTH	PVT	Unknown	none	none			1						1	Injection site erythema; Injection site swelling; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0627Y~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359329	10/02/2009	NY	39.0	39		F	09/30/2009	Patient c/o ringing in her ears, + flushing, chest pressure a coughing treated with Epi @ clinic site taken via ambulance to hospital with Decadron & Pred. Sent home with Medical PAC, Pepsid & Benadryl.				Y					Y	09/29/2009	09/29/2009	0	None	PUB	PVT		None	Anaphylactic reactions to antibiotics			1						1	Chest discomfort; Cough; Flushing; Tinnitus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA259AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0359330	10/02/2009	IA	54.0	54		F	10/02/2009	Pt felt very flush and had redness in her face; was in store over an hour and indicated anxiety w/shots. Left with daughter feeling better.									Y	10/02/2009	10/02/2009	0		OTH	PVT						1						1	Anxiety; Erythema; Flushing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848PA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359233	10/03/2009	GA	35.0	35		F	10/03/2009	Facial swelling (particularly eyelids), facial itchiness.  Treated with liquid benadryl immediately and every 6 hrs after.									Y	10/02/2009	10/02/2009	0		UNK	PUB		No	allergies to pollen, dust, cipro, avelox, phenergan	facial swelling~Influenza (Seasonal) (no brand name)~UN~31.00~Patient		1						1	Eyelid oedema; Pruritus; Swelling face	FLUN3~MEDIMMUNE VACCINES, INC.~~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0359234	10/03/2009	MI	56.0	56		F	10/03/2009	Developed bilateral lower and upper extremity weakness as well as paresthesias two days after vaccine administration. Later, she developed neuropathic pain in her upper back. Patient is currentely hospitalized and her laboratory tests are consistent with a diagnosis of Guillain Barre Syndrome - AIDP. She started receiving IVIg as a treatment on 10/02/2009. At her day 2/5 of her therapy, symptoms still persist.  10/8/09 Hospital records received service dates 9/29/09 - 10/21/2009. Assessment: Paresthesias suspect GBS. Urinary tract infection. Patient fell while walking her dog. Sudden onset of tingling and numbness feet bilateral the next day which resolved. Developed numbness feet bilateral, low back pain relieved by chiropractic treatment. Numbness continued in lower extremities, upper back pain, unable to sleep, increased sensitivity and pain bilateral temple, head, neck regions. Unsteady on feet due to weakness. Decreased sensation and weakness lower extremities, weakness in thumbs. 12/3/2009 D/C Summ and additional records rec'd.  Date of D/C 10/21/2009 with D/C DX:  AIDP. 2' DX: UTI.  Hematuria. Complication:  Neuropathic Pain.   D/C for Inpt rehab				Y	Y	26			U	09/17/2009	09/26/2009	9	10/8/09 Hospital records received service dates 9/29/09 - . LABS and DIAGNOSTICS: CSF - Glucose 76 MG/DL (H) Protein 92 MG/DL (H). Creatine Phosphokinase 21 IU/L (L). CHEM - Glucose 136 MG/DL (H) Potassium   3.4 mMOL/L (L) Sodium 147 mMOL/L (H) Chloride 112 mMOL/L (H) Calcium 8.5 MG/DL (L) Creatinine 1.1 MG/DL (H). CBC - Hematocrit 34.5% (L) Neut 85.3% (H) Lymph 12.1% (L). CT Abdomen - Abnormal, foci of air in gallbladder. MRI Cervical / Thoracic Spine - Abnormal, multiple hemangiomas. MRI Brain - Abnormal, left frontal lobe alterations. Urinalysis - Cloudy, Glucose +, Ketones +, Renal Epithelial Cells occasional, Transitional epithelial cells present, Mucous much, WBC 26-50 HPF (H), WBC Clumps Present, WBC Casts present. EMG-abnormal.	UNK	UNK		No	No. 10/8/09 Hospital records received service dates 9/29/09 - Still inpatient. Dermatofibroma left breast. Tinnitus. Sensorineural hearing loss. Tendinitis. Breast biospy for lipoma. Abdominal hysterectomy and salpingo-oophorectomy for fibroids, varicose vein stripping, tonsils and adenoids removed.			1						1	Back pain; Blood product transfusion; Guillain-Barre syndrome; Laboratory test abnormal; Muscular weakness; Neuralgia; Paraesthesia	FLUX~SANOFI PASTEUR~U3197AB~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0359235	10/03/2009	NV	53.0	53		M	10/03/2009	uncontrollable shivering, rapid pulse followed by high fever, nuasea, dizziness, difficulty breathing and horsenees.									Y	10/02/2009	10/02/2009	0		PUB	PVT	Chantix	none	Mild allergy to grasses			1						1	Chills; Dizziness; Dysphonia; Dyspnoea; Heart rate increased; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0359236	10/03/2009	PA	29.0	29		F	10/03/2009	shortness of breath, airway obstruction (blood/mucous), several asthma attacks, coughing, vomiting, bloody mucous/vomit, extremely high fever, body chills, aches, headache, vertigo, bladder urgency/incontinence, throat rawness, eye pain & pressure, double vision, poor muscle control									U	10/02/2009	10/03/2009	1	pending doctor's visit if illness does not end	UNK	UNK	acebutolol, lamictal, omeprazole, singulair, topamax, ambien, fioricet w/codeine, valium, bentyl, zyrtec, concerta, proair	no	asthma, high blood pressure, anxiety, IBS			1						1	Asthma; Chills; Cough; Diplopia; Dyspnoea; Eye pain; Haematemesis; Headache; Hypotonia; Micturition urgency; Obstructive airways disorder; Oropharyngeal pain; Pain; Pyrexia; Urinary incontinence; Vertigo; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359237	10/03/2009	NY	34.0	34		F	10/03/2009	Per Employee: Seen by neurologist with hospital admission. Apparently lost feeling in right hand and tingling in the palm of right hand and discoloration of fingers. Vaccine was administered into Left deltoid. Spent week in hospital per employee. Follow-up: The employee went to ER @ hospital the eve of 9/3/09 and was transferred and admitted from 9/4/09-9/9/09.					Y	7			U	08/26/2009				OTH	PUB		No				1						1	Hypoaesthesia; Paraesthesia; Sensory loss; Skin discolouration	FLU3~CSL LIMITED~01949211A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Hospitalisation	Influenza
0359255	10/03/2009	NC	44.0	44		F	10/03/2009	First felt with whole body with burning sensation,severe urge to urinate.Went to bathroom ,lost control with bowel&bladder.While urinating hands $ whole scalp was itching.Then noticed with mottled skin on bilateral thighs & face & eyes were very red.Felt very weak.Somehow came out of bathroom,Could not even walk,called for help.Felt like passout,Short of breath.As per viewers ,I became very pale white grayish in color.I felt like I am dying .BP 90/50.Blood glucose 102,Oxygenation was 60-70%.Given O2 & taken me to ER.During this time I was cant even talk/stand.ER did all labs,EKG, By 6 PM On & Off becoming pale & body is cold.by 7.30 pm got Benadryl 25mg IV.Then slept for 15 mts,woke up ,felt very good.Then given me Inj Solumedrol 125 mg IV.By 830 got discharged.walked to parking lot.Discharged with Prednisone 60 mg x3 days & Benadryl 25 mg TID x 3 days.I was very weak for a week.Now I feel Okay.				Y					Y	09/24/2009	09/24/2009	0		PUB	PVT		Nil	Nil			1						1	Asthenia; Blood glucose increased; Blood pressure decreased; Burning sensation; Dizziness; Dyspnoea; Electrocardiogram; Erythema; Faecal incontinence; Feeling cold; Livedo reticularis; Micturition urgency; Ocular hyperaemia; Oxygen saturation decreased; Pallor; Pruritus; Urinary incontinence	FLUX~UNKNOWN MANUFACTURER~~6~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0359256	10/03/2009	MN	70.0	70		F	10/03/2009	Arm began to ache in shoulder and I was unable to lift my arm above my waist.  I took two Advil about 10:00 PM, awakened the second time about 5:00 AM  (Oct 2) and the entire shoulder bone ached and was still unable to move my arm above the waist.  I talked with our medical nurse and she advised me to go to the emergency room.  He advised taking Advil (up to 800 mg) and the pain should subside in a day or two.   It has improved greatly in the last 24 hours.				Y					Y	10/01/2009	10/01/2009	0		UNK	UNK		Pneumonia shot given as well	None			1						1	Injected limb mobility decreased; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~0112~1~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~4739~1~~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0359257	10/03/2009	FL	57.0	57		F	10/03/2009	Felt dizzy and nauseous, very tired went to sleep for several hours.  Didnt feel like eating and had a headache.  Injection site very warm and reddish. Went to bed and woke up at @1:30 AM with excruciating pain in arm..took asprin..very woozy and delirious..had vivid nightmares..arm very very painful...put cold pack around arm and fell asleep.  Did not wake up until about 9:30 AM 09/29/2009..knuckles hurt, knees hurt,hips hurt injection site lobster red and swollen felt feverish, no temp. redness appeared to wrap around arm...couldn't stay awake went back to  bed and slept 3-4 hours..called health dept. they were to call back. Felt worse as day progressed. 09/30/2009..fainted when making coffee,felt horrible, called health department.  P.A. called back in afternoon and said drink fluids, take tylenol and alternate with ibuprofen..ice packs only (Ihad asked about heat)..keep eating and monitor temp.None to date.  Checked back w/health dept. next day left message and no return call. This is 10/03/2009 and I am really starting to feel human again. Redness completely gone from site, but I still am experiencing some joint pain, hardness at site and solar plexus pain.  I think I am going to live...it really felt like the Flu I experienced 3 years ago, but the P.A. said it probably wasn't the Flu vaccine, it was the PPSV. Thank goodness you only get it once every 5 years.									Y	09/28/2009	09/28/2009	0		PUB	PUB	Paroxetine 20mg 2xd;Enalapril 20mg 2xd;Symbicort 160/4.5 2xd; Proventil HFA;	no	COPD, HTN , Chronic Depression			1						1	Arthralgia; Decreased appetite; Delirium; Dizziness; Fatigue; Feeling abnormal; Headache; Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth; Nausea; Nightmare; Pain in extremity; Syncope	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0359258	10/03/2009	UT	31.0	31		M	10/03/2009	Sore throat. Stiffness of muscles: 8 out of 10 level of pain that lasted four days. Pain only occurred when moved: if kept still no pain. Pain was like every muscle had been ripped or pulled. Which muscles had extreme pain: legs, stomach, back, arms. Extreme pain finally subsided 10/01/2009, replaced with weakness in arms, struggle to write and lift objects, and constant fatigue. Went to the doctors on 09/28/2009 and reported extreme pain: tested for N1H1: results reported negative on 09/29/2009. I believe that this has been an allergic reaction to the flu shot.				Y					U	09/24/2009	09/25/2009	1	Tested for N1H1 9/28/2009: results reported negative on 09/29/2009.	UNK	PUB	None to the above and I am currently not on any medications.	None	None			1						1	Dysgraphia; Fatigue; Influenza serology negative; Muscular weakness; Musculoskeletal stiffness; Myalgia; Oropharyngeal pain; Pain	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0359260	10/03/2009	GA	1.5	1	.6	M	10/03/2009	Fever followed by red pin prick rash on torso and upper back									U	09/25/2009	10/01/2009	6		PVT	PVT		no	no			1						1	Pyrexia; Rash; Rash erythematous	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~3~~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1|MMR~MERCK & CO. INC.~~1~~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0359261	10/03/2009	PA	29.0	29		M	10/03/2009	Enlarged nodes in neck on the right side just above the collar bone.  Sore like a bruise, especially to touch.				Y					Y	09/29/2009	09/30/2009	1		PVT	UNK		No.	No.			1						1	Lymph node pain; Lymphadenopathy	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA283AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0359262	10/03/2009	NJ	53.0	53		F	10/03/2009	HIGH FEVER OF 103 LAST UNTIL 09/21/09 4 AM, THN START TO GO DOWN TO 101 09/22/09 WENT DOWN O 99, WEAKNESS, DIZZENESS, NOT ABLE TO EAT OR DRINK, HEADACH SEVER PAIN IN MY KNEE & MY BACK, NOT ABLE TO STAND OR WALK I FELT VERY WEAK DISORINTED NOT GET UP FROM BED FOR 36HRS, IHAVE TO USE ICE PK ON MY HEAD, TAKING TYLENOL 650 MG Q4HR AROUND THE CLOCK & IBUPROFEN AT LEAST 4 TIMES A DAY ON SUNDAY, .PROBLEM TO BREATH, CHILLIS.CONTACT MY PHYSICAIN ON sunday 09/20/2009 10 pm he ask me to go to ER IN OVERLOOK HOSPITAL IN NJ OR IF I CAN WAIT TO BE SEEN IN THE NMORNING IN THE OFFICE, HE SAID IT IS UNLIKLY THAT I HAD THE FLU BECAUSE THE VACCINE IS INACTIVE, I SW MY DOCTOR ON MON DAY 09/21/2009 AROUND NOON TIME STILL HAD A FEVR, HE SAID HIGH FEVER IS NOT ACOMMON SIDE EFFECT OF VACCINE, HE ASK ME TO  REST & NOT TO GO TO WORK UNTIL I FEEL BETTER CONTINUE TYLENOL & IF TEMP DOES NOT GOE WITHIN 24HR I HAVE TO GO BACK TO THE OFFICE,BY TUES 09/22/09 10 AM I FELT BETTER, I DID NOT GO BACK TO THE OFFICE , IWENTBACK TO WORK, IDID NOT REPORT THIS YET AT BELLEVUE HOSPITAL BUT I WILL.				Y					Y	09/19/2009	09/20/2009	1	DOCTOR OFIICE	PUB	UNK		no	no			1						1	Arthralgia; Asthenia; Back pain; Chills; Disorientation; Dizziness; Dysstasia; Gait disturbance; Headache; Hypophagia; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA474CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0359263	10/03/2009	GA	15.0	15		F	10/03/2009	Syncope - Running a 5K, child is a half marathoner and 5K state champion. Pulse went to 172. Ash gray in face and memory loss of event. This had never happen before, occurred again on 10/3/2009. Emergency room, doctor ran EKG and ECO showed nothing. 10/28/2009 records from Cardiologist and PCP for dates 9/22/2009 and 10/13/2009. Patient presented with sx of syncope, incoherent speech, paleness, and passing out while running a marathon on 9/19/2009. Cardiac workup was negative. Patient saw new PCP 10/13/2009, asymptomatic at this time. Further dx tests were ordered.				Y					U	09/16/2009	09/19/2009	3	Blood work, sugar level check, EKG and ECO all negative. Labs: CBC, CRP, CMP, complement studies, ANA profile, ESR, TSH, Ferritin WNL Dx tests: Echo, Holter monitoring, EKG WNl	UNK	UNK		None	None PMH: Anorexia Nervosa, Amenorrhea Allergies: NKDA			1						1	Amnesia; Blood test normal; Echocardiogram normal; Electrocardiogram normal; Heart rate increased; Skin discolouration; Syncope	FLU3~SANOFI PASTEUR~U3209AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0672Y~2~IM~LA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0359292	10/03/2009	AZ	35.0	35		M	10/03/2009	Pt flush c/o nausea, confusion, diaphoresis and sick.  BP 130/80 P74- pt on co + next to RN for observation and cont. monitoring.  Denies SOB/tighness in chest.									Y	10/03/2009	10/03/2009	0		MIL	MIL	None	None	None			1						1	Confusional state; Flushing; Hyperhidrosis; Malaise; Nausea	FLUN3~MEDIMMUNE VACCINES, INC.~500685~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0359293	10/03/2009	DE	55.0	55		M	10/03/2009	Swelling of lips and eyes. Within 2 hrs Conjanitiva red. Chills followed by sweats. 4-5 hrs. after vaccine fine the next day.									Y	09/19/2009	09/19/2009	0	None	OTH	UNK	No	No	None			1						1	Chills; Conjunctival hyperaemia; Eye swelling; Hyperhidrosis; Lip swelling	FLU3~SANOFI PASTEUR~U3204AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359294	10/03/2009	FL	44.0	44		F	10/03/2009	Patient had arm swelling @ injection site, lightheaded, fainting sweating- Patient given 1 dose of EPIPEN.				Y					Y	10/03/2009	10/03/2009	0	BP- 120/80 Glucose- 84	OTH	PVT	ATENOLOL 50mg	None	Mitral valve prolapse;  Palpitations			1						1	Blood glucose normal; Dizziness; Hyperhidrosis; Injection site swelling; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97843P2~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359295	10/03/2009	ME	12.0	12		F	10/03/2009	Administered FLUMIST, VARIVAX #2. Patient vomited, hives, tired, dizzy. Administered Xyzal to patient. Hives disappeared and felt better. Nausea stopped. Observed patient then went home.									Y	10/01/2009	10/01/2009	0	None known	PVT	PVT		None known	Type II ahyperlipidemia			1						1	Dizziness; Fatigue; Nausea; Urticaria; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500709P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~0847Y~2~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0359296	10/03/2009	OH	57.0	57		F	10/02/2009	On hour after receiving the vaccination, pt complained of itching arms, hot facial cheeks, and slight rash on chest. Pt took 50 mg Diphenhydramine. Refused further medical treatment. Within 15 minutes, symptoms had abated. Paint on arms from remodeling could have played a role.									Y	10/02/2009	10/02/2009	0		OTH	PVT						1						1	Pruritus; Rash; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848PIC~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359297	10/03/2009	TX	80.0	80		M	10/03/2009	Swelling at shoulder joint - MD states- possible injection into/swelling of bursa (became Acute care).				Y					U	09/25/2009	10/01/2009	6	MD ordered	OTH	UNK						1						1	Injection site swelling; Joint swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~978491~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359305	10/03/2009	NY	42.0	42		F	10/02/2009	Employee received flu vaccine on 10/01/2009 at 4 pm in Employee Hospital around 7pm she began to experience chills, body aches and malaise. Patient was seen and treated in the E.D. ED doctor stated that employee was level and at a post vaccine reaction. Employee was discharge home.				Y					U	10/01/2009	10/01/2009	0	None	PUB	UNK	Albuterol; Singulair; Advair					1						1	Chills; Immunisation reaction; Malaise; Pain	FLU3~SANOFI PASTEUR~UT3175BA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359316	10/03/2009	VA	54.0	54		F	10/02/2009	Fever-104 last night. shot given on 09/30/09. Patient took ADVIL.									Y	09/30/2009	10/01/2009	1	No	PUB	PVT	NORVASC; PRINIVIL; GLUCOPHAGE; ZOCOR; SINGULAIR	No	No			1						1	Pyrexia	FLU3~SANOFI PASTEUR~U43214AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2932AA~1~UN~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0359238	10/04/2009	IN	39.0	39		F	10/04/2009	felt sick, nausea, had diarreha, then it was hard to swallow, i needed water, it became hard to breath, i became very hot, my heart rate was very fast. had to lay down. this was all in about a 15-20 min. time span..i was in a public theater lobby. i was in bad shape...a person near by called an ambulance. i was taken to the emergency room.				Y					Y	09/18/2009	09/18/2009	0		PVT	UNK	sertraline 200mg per day	no	allergies: penecillin ......no medical conditions or problems at time of vaccination.			1						1	Diarrhoea; Dysphagia; Dyspnoea; Feeling hot; Heart rate increased; Malaise; Nausea	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0359239	10/04/2009	IN	34.0	34		F	10/04/2009	Arm pain at injection site was the first.  The pain intesified the remainder of the day and continued for 3 days.  My arm swelled Thursday night, the night of the shot.  It was difficult to sleep Thurs and Fri nights.  As of today, 3 days after the shot, my upper arm is still swollen and now numb.  It was a little numb and tingly yesterday.  I, also, have no energy at all today and keep getting dizzy.  Arm does still hurt today too. Bending my arm at the elbow is fine, but it is very difficult to use shoulder movement.										10/01/2009	10/01/2009	0		UNK	UNK		none	I do have numerous allergies; from latex to penicillin to milk products to mosquitoes.  I am allergic to many foods and animals and environmental stuff.  We decided it best to get a vaccine since I have had vaccines in the past and was fine afterwards, and esp. since I tend to get ill easily and difficulty recovering.			1						1	Asthenia; Dizziness; Hypoaesthesia; Hypokinesia; Injection site pain; Insomnia; Oedema peripheral; Paraesthesia	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359240	10/04/2009	NJ	53.0	53		F	10/04/2009	I received my Influenza vaccine at work on 9/21/09 (free to employees at Cafeteria through Employee Health Services).Had nothing but mild arm pain until 8 days later, when  I woke up with severe neck and ear pain (on same side as injection. On 9/30, I felt extreme fatigue, headache and continued increase in pain in area noted above. On 10/1, went to PCP, who noted blister like sores behind my ear and in my scalp. She diagnosed me with shingles. The blisters have now progressed to the entire back of the left side of my scalp, my neck, my ear and my cheek. I was RX'd Valtrex, Levaquin for cellulitis prophylaxis and pain medication. I am now on D4 of these meds and continue to have new eruptions. I am an otherwise healthy 53 year old with no immune deficiencies. I will not be allowed to return to work untl my blisters have stopped erupting and have begun to dry.If they begin to erupt near my left eye, I will be hospitalized in order to prevent serious eye damage/blindness.				Y					N	09/21/2009	09/29/2009	8	N/A	PUB	UNK	Aciphex 20 mg/qd Zoloft 50 mg/qd Lipitor 10 mg/qd	None	Allergy to penicillin			1						1	Blister; Cellulitis; Ear pain; Fatigue; Headache; Herpes zoster; Neck pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0359242	10/04/2009	TX	50.0	50		F	10/04/2009	Received Anthrax booster IM in right deltoid am of 10/03/2009.  Patient awoke at 0100 with severe pain in right shoulder radiating up toward neck and down into right arm.  She also experienced a localized redness (which she has experienced with past injections).  She required narcotic pain medication to aleviate pain.  Movement increased pain to shoulder so at 10:00 AM 10/04 pt placed arm in sling. Patient stated she may see her physician if pain is not better by Monday 10/05.									U	10/03/2009	10/04/2009	1		MIL	MIL	None	None	Allergy to Sulfa			1						1	Erythema; Musculoskeletal pain; Neck pain; Pain in extremity	FLU3~SANOFI PASTEUR~U2501AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359244	10/04/2009	TX	23.0	25		F	10/04/2009	9/22/2009: Broke out in hives around site of injection and at the same time around my lower right knee, accompanied by a rash. Intense itching. That night had extreme migraine (I never get migraines) to the point I couldn't study and had to lay down. For two days later my head felt like I couldn't think. Hives went away by morning of 9/23 but they continued to come back with extreme itching in various parts of my body including my arms, legs, and side of face. The most intense itching was on my lower legs, benadryl did not relieve the symptoms. This cycle of extreme itching continued for over a weeek. On 9/29/09 evening, while still experiencing the itching in my lower legs, I noticed my legs were becoming swollen and I had lumps under the skin of my legs, I could see from looking at my leg from the side. My legs felt funny to touch, like the sensation was different, the skin was more taunt, and muscles more stiff, the skin was warmer to touch than the rest of my body. I went to see my doctor on 9/30 and he said I was having an allergic reaction that was very rare. He put me on medrol pack, allegra (changed to zyrtec because insurance didn't cover allegra) and bendryl every 4 hrs. I started the medrol Thursday Oct 1st. Oct 1st evening the swelling was still present, with weird sensation, taunt skin. My legs were sore below the knee and did feel weak toward the evening. The itching was still present in waves, but seeming to improve with the addition of zyrtec. By Friday I had noticed no improvement of my lower legs. I was waiting for the medrol to work. I worked Friday evening night shift and as the night progressed my lower legs felt tingling, even more decreased sensation to touch. It felt numb but I had no difficulty walking or moving. I became concerned with the worsening of my legs and called an on-call nurse at 4 AM Oct 3rd while I was at work. She decided that I should be re-evaluated that morning but I didn't need to go to the ER. I was able to see a doctor by 9AM, by then my legs felt incredibly decreased sensation, worse going further down the leg,to the point I couldn't feel the touch. My feet were tingling in the waiting room and felt cold. The decreased sensation was also now felt on my  lower thigh going higher. By the time I was in the exam room and took my socks off all my toenails were blue. My legs were swollen but and the doctor did say on exam with poking my leg with some plastic thing that my sensation was decreased. My lower legs didn't feel like my legs. She had me do some muscle strength tests and decided that since I'm not having any decrease strength that it wasn't guilliane barre. She told me to continue with the medrol and medications and see a doctor if I experience weakness. Since then I have noticed an improvement in the sensation, but it is still present and I haven't finished my medrol yet. I'm still taking zyrtec and benadryl so I'm not sure if the itching will come back when I go off those.				Y					N	09/21/2009	09/22/2009	1		PUB	UNK	birth control	No	No			1						1	Asthenia; Cyanosis; Feeling cold; Injection site urticaria; Migraine; Muscular weakness; Musculoskeletal stiffness; Oedema peripheral; Pain in extremity; Paraesthesia; Pruritus; Rash; Skin mass; Skin warm; Urticaria	FLUX~UNKNOWN MANUFACTURER~~3~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0359245	10/04/2009	TX	75.0	75		M	10/04/2009	INCREASED PAIN AND REDDNESS APPROXIMATELY 2 INCHES BELOW INJECTION SITE									U	10/02/2009	10/04/2009	2		PUB	PVT	CLONIDINE, EXFORGE,& DARVOCET	NO	ALLERGIC TO PENICILLINS AND CEPHALOSPORINS			1						1	Injection site erythema; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359246	10/04/2009	FL	31.0	31		F	10/04/2009	Patient called clinic and stated that she was having radiating pain down to hand from injection site.  Denies pain during injection.  Stated that it started approximately 3 hours later. She applied ice which made it feel worse when the ice was removed and took tylenol before she called.  It was too soon to know if Tylenol helped.									U	10/03/2009	10/04/2009	1	None at this time	PUB	UNK	None	None reported	Pregnant, Soy allergy			1						1	Injection site pain; Pain	FLU3~SANOFI PASTEUR~U3176DA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359247	10/04/2009	PA	55.0	55		F	10/04/2009	SX FIRST STARTED WITH A VERY STIFF NECK, FOLLOWED BY DESCENDING STIFFNESS AND JOINT PAIN ( EVERY ) JOINT. AND CONTINUED OVER SEVERAL DAYS , EACH DAY THE STIFFNESS AND PAIN INCREASED. AS A NURSE I TOOK ASA, MOTRIN AND TYLENOL TO GET THRU MY DAY. i USED MY HUSBANDS PRESCRIPTION VICODAN @ NIGHT ON 9/18 & 9/19. BY 9/19 PM I HAD DIFFICULTY WALKING AND PROFOUND WEAKNESS ALONG WITH PAIN, NO GRIP STRENGTH IN EITHER HAND. MY HUSBAND HAD TO DRESS ME, GET ME DOWN 13 STEPS( COULDN'T PICK UP MY FEET OR KNOW WHERE MY FEET WERE LANDING ). HE TOOK ME TO MY PLACE OF EMPLOYMENT. I WAS ADMITTED GIVEN IV FLIUDS, IV PAIN MEDS, PHYSICAL THERAPY, MRI'S AND BLOOD WORK. MY HOSPITAL STAY WAS 9-20-09  TO 9-23-09. I WAS ALSO SEEN BY A NEUROLOGIST. 10/26/2009 records for 9/20/2009. Patient with sx of neck stiffness, diffuse arthralgias and myalgias, weakness, numbness/tingling of hands. PE noted diffuse weakness with decreased ROM of the extremities. Neuro consult 9/21/2009, PE noted gag reflex depressed bilaterally, DTR's rt knee absent, DTR's UE's decreased, DTR's absent in ankles bilaterally with decreased strength all extremities. Tx: IVF, Toradol IV Resp therapy tx's. Suspected dx GBS.					Y	4			U	09/15/2009	09/23/2009	8	MRI HEAD, NECK, LYME TITER, RHEUMATOID FACTORS, CBC, CHEM, CPK, SED RATE, HEPATITIS PROFILE. Labs: CBC, wbc 12.4 high, neutrophils 84.6 high, lymphs 10 low, RA factor neg, EBV neg, CMV titer +, ANA and Anti DNA neg, CMP, Glucose 127 high, CK norm, ESR 59 high, Hepatitis panel neg Dx studies: MRI Brain, C-spine, EMG/NCV studies all normal/negative.	UNK	UNK		no ( had been recently treated for an ear infection 2 wks previously, was checked the day before the shot and declared infection free	none PMH: hx of gastric by-pass surgery Allergies: Demerol and Erythromycin			1						1	Activities of daily living impaired; Arthralgia; Asthenia; Blood creatine phosphokinase; Blood test; Borrelia burgdorferi serology; Full blood count; Gait disturbance; Grip strength decreased; Hepatitis viral test; Joint stiffness; Laboratory test; Musculoskeletal stiffness; Nuclear magnetic resonance imaging; Pain; Red blood cell sedimentation rate; Rheumatoid factor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97850P1~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0359249	10/04/2009	MI	11.0	11		M	10/04/2009	Head ache and fever of 101 degrees Called pharmacy and instructed to give Motrin and Tylenol									Y	10/02/2009	10/03/2009	1		PUB	PVT	Mulit Vitamin	NO	None			1						1	Headache; Pyrexia	FLU3~CSL LIMITED~02349211A~1~~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359250	10/04/2009	NJ	7.0	7		M	10/04/2009	7 year old patient came to clinic for seasonal influenza vaccine (FLUZONE - Sanofi Pasteur - .5mL SDV (Ages 36 months+) Thimerosal and Preservative Free). Injection site, on upper left arm, was swabbed with alcohol prior to injection.  Approximately 4 hours after injection, patient developed redness at the site.  Oral Benadryl was administered in the age-appropriate dose, but redness nevertheless worsened.  Topical Benadryl cream was administered, but did not alleviate redness.  For the next +/- 48 hours, the red area gradually became larger, more swollen, and harder; the redness became darker, and site eventually became hot to the touch.  Benadryl, alternating both orally and topically, continued to be administered, but did not help.  At this point (roughly 52 hours following injection) patient was taken to his pediatrician - by this time, red swollen area was more-or-less an oval roughly 5 inches wide, and 7 inches long (along length of arm with injection site as center point).  Pediatrician suspected cellulitis was developing.  Prescribed both oral steroids (Orapred) and oral antibiotics (Clindamyicin).  Swelling, hardness, and red coloration gradually subsided over the next several days.  To date (roughly 3 weeks following injection), some redness of area persists. Patient never complained of pain in area, however there was moderate itching.  Patient was told not to scratch, and appeared to comply.  Patient has no known food, substance, or medication allergies, other than a history of reactions to the influenza vaccine.  No egg allergies whatsoever.  In two prior years, patient had similar or more sever reactions to influenza vaccine (one year, site started to develop Necrotizing Fasciitis, which eventually subsided after I.V. administration of vancomysin).  During 2 years that he was not vaccinated (due to fear of reaction due to history), patient developed severe influenza, which precipitated asthma attacks (in one case, a life-threatening asthma attack that required a 2 weeks I.C.U. admission).  Due to patients reactions to influenza vaccine, parents are reluctant to continue having them administered.  However, due to patient's propensity to get the flu when vaccine is not administered, and the sever impact it has on his asthma, failure to administer vaccine can have severe consequences.				Y					Y	09/12/2009	09/12/2009	0	None.	PVT	PVT	Flovent	None	Asthma	Same as present~Influenza (Seasonal) (no brand name)~1~3.00~Patient|Same as present~Influenza (Seasonal) (no brand name)~1~5.00~		1						1	Cellulitis; Influenza; Injection site discolouration; Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth; Necrotising fasciitis; Pruritus	FLU3~SANOFI PASTEUR~u3259ea~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359251	10/04/2009	NY	27.0	27		F	10/04/2009	Woke up in a cold sweat and had abdominal cramps.  I was very thirsty and had difficulty urinating.  I was experiencing extreme dizziness and had difficulty seeing well enough to open a bottle of pain relievers and get a glass of water.  I decided to lie down for a whle and in the short distance back to my bed, the dizziness was so bad that it caused me to fall over.  I tried to pick up my glass of water, but couldn't see well enough to find it.  I also felt nauseous.  After lying down for over an hour, the cold sweat was gone and I experienced only very mild dizziness sporadically for the rest of the day.									Y	10/01/2009	10/01/2009	0		UNK	UNK	Levoxyl	none	Hypothyroidism			1						1	Abdominal pain; Cold sweat; Dizziness; Dysuria; Fall; Nausea; Thirst; Visual acuity reduced	FLUX~UNKNOWN MANUFACTURER~~1~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359264	10/04/2009	GA	4.0	4		F	10/04/2009	REDNESS IN RT UPPER ARM 3IN.DIAMETER/SLIGHTLY WARM/2 LONG/PUFFY									Y	09/30/2009	10/02/2009	2		UNK	UNK		NO				1						1	Injection site erythema; Injection site swelling; Injection site warmth	DTPIPV~UNKNOWN MANUFACTURER~AC20B116BA~1~IM~RA~DTP + IPV (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~UT3178EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0715Y~3~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1047Y~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0359267	10/04/2009	WV	77.0	77		F	10/04/2009	Soreness, heat in arm, swelling,unable to raise arm. Swelling has continued to 10/04/2009 along with redness  and soreness.  Not as sore as Friday-able t raise arm Sunday.				Y						10/02/2009	10/02/2009	0		UNK	PUB						1						1	Erythema; Mobility decreased; Oedema peripheral; Pain in extremity; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~90658~UNK~~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359282	10/04/2009	VA	20.0	20		U		30 min post injection, patient was light-headed and nauseous. She, vomited once and went home from work. Patient stated she was fine after that dizzy spell.									Y	10/02/2009	10/02/2009	0		OTH	PVT		None	None			1						1	Dizziness; Nausea; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P1~4~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359284	10/04/2009	OH	55.0	55		F	10/04/2009	Vaccine given 9/26/09. Patient complained of Diarrhea on 9/26/09. Started on 10/2/09. Patient seen in ER. On 10/4/09. Patient said Doctor gave steroids dose pack, said Doctor told her possible allergy to component in shot. Doctor also questioned. Patient about possible chicken pox. Patient going to see family MD. 10/05/09.				Y					N	09/26/2009	09/26/2009	0		OTH	PVT	Unknown	Seasonal Allergies	Seasonal (erythromycin sulfa)			1						1	Diarrhoea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960323P~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359286	10/04/2009	IN	83.0	83		F	10/04/2009	Patient stayed at pharmacy for 20 min and felt fine. Later that night she told her daughter she wasn't feeling well. She talked with her doctor that morning. Doctor didn't think it was from vaccine. Daughter took her to ER that day. Pt was slightly dehydrated w/UTI, BP was low ER doctor told her to never get flu shot again.				Y					Y	09/30/2009	09/30/2009	0		PUB	PVT	LASIX; SULAR; Synthroid; LIPITOR; SPIRIVA; AVALIDE; AMARYL; Metoprolol; Metformin	None	Diabetes; Hypertension; Hyperlipidemia; COPD; CHF	None~ ()~~0.00~Patient		1						1	Dehydration; Hypotension; Malaise; Urinary tract infection	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960321P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359287	10/04/2009	NJ	57.0	57		M	10/04/2009	Patient experienced joint pains and slight fever.									Y	10/04/2009	10/04/2009	0		OTH	PVT						1						1	Arthralgia; Pyrexia	FLU3~SANOFI PASTEUR~UT8172AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359289	10/04/2009	NJ	18.0	18		M	09/22/2009	Patient experienced arm pain about 15 minutes post vaccination and nausea 30 minutes post vaccination.									Y	09/22/2009	09/22/2009	0		OTH	OTH	None	none	none			1						1	Nausea; Pain in extremity	FLU3~SANOFI PASTEUR~U3178BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359291	10/04/2009	IL	68.0	68		F	10/03/2009	Bruising at site of injection 1 inch in diameter left arm  red itching right ear, right, left forearms, scalp, waist, abdomen, upper thigh right, left.				Y					U	10/01/2009	10/03/2009	2	Unknown	OTH	PUB	Nitrofurantoin 100mg	None	Sulfa; Penicillin			1						1	Erythema; Injection site haematoma; Pruritus generalised	FLU3~CSL LIMITED~6349111A~1~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0359414	10/04/2009	MS	36.0	36		F	10/04/2009	I began with tiredness and upset stomach. I am sick as I write this so the it is possibly not very coherent. 1)extreme sore throat, almost cannot swallow 2)running nose, sneezing 3)cough 4)mild fever, I have not checked my fever unmedicated.  5)Nasal Congestion and I almost forgot the massive 6)Headaches I had when the symptoms were beginning. As well I do not know if I am contagious or not due to the fact that I got sick from the vaccine.  Please notify me.  I am taking precautions in hygiene and wearing face masks but I am not quarantined.  The nurse said I would get mildly get sick, but I slept all day yesterday and can barely move today.										09/30/2009	10/03/2009	3		UNK	UNK	I am presently taking Methotrexate 4@2.5 mg per week, Nifedipine 90 mg per day, Tramadol 3x per day, Lorcet only as needed, I can't remember all the others, this is the major medicines I take daily or weekly.	Chronic.  On file at my physicians.  Primary Raynaud's Disease and Polyarthritis.	n/a			1						1	Abdominal discomfort; Cough; Dysphagia; Fatigue; Headache; Nasal congestion; Oropharyngeal pain; Pyrexia; Rhinorrhoea; Sneezing	FLU3~CSL LIMITED~05949111A~1~~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0357732	10/05/2009	MT	37.0	37		M	09/30/2009	Initial report received on 21 September 2009 from health care professional. VAERS E-Report number E-31933. This case represents one patient of a cluster of three patients from the same reporter. Information regarding the other two patients is reported in cases 2009-04031 and 2009-04032. A 37-year-old male patient, who had no concurrent illnesses and medical condition of asthma, had received a fifth intramuscular left arm injection of FLUZONE SV 2009-2010 (lot number U3194AA) on 18 September 2009 at 13:30 hours. Three hours post-vaccination, the patient experienced eye redness, swelling and itching. Approximately one half hour later, he developed lung congestion, bottom lip swelling and his face was flushed. He also had muscle ache/pain. A fever followed. The patient self medicated with DAYQUIL and ALBUTEROL via nebulizer that he uses for asthma. The patient did not require medical evaluation. At the time of this report, the patient had recovered; however a recovery date was not provided. Documents held by sender: None.				Y					Y	09/18/2009	09/18/2009	0	None reported	PUB	PUB	Flax oil; Vitamin E, Fish oil; Garlic; B Complex	The patient had no concurrent illnesses at time of vaccination. He has current medical condition of asthma.			200904030	1						2	Eye pruritus; Eye swelling; Flushing; Lip swelling; Myalgia; Ocular hyperaemia; Pulmonary congestion; Pyrexia; Eye pruritus; Eye swelling; Flushing; Lip swelling; Myalgia; Ocular hyperaemia; Pulmonary congestion; Pyrexia	FLU3~SANOFI PASTEUR~U3194AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U3194A~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0357733	10/05/2009	MT	61.0	61		M	09/30/2009	Initial report received on 21 September 2009 from a health care professional. VAERS E-report number E-31934. This case represents one patient of a cluster of three patients from the same reporter. Information regarding the other two patients is reported in cases. 2009-04030 and 2009-04032. A 61-year-old male patient, who had no concurrent illnesses, and who was taking blood pressure medication (Trade name and indication not reported) at the time, had received a first intramuscular left arm injection of FLUZONE SV 2009-2010 (lot number U3194AA) on 16 September 2009 at 18:00 hours. Four hours post-vaccination, the patient's throat felt itchy. Subsequently, the patient woke up at midnight that night with a swollen tongue and lower lip, some wheezing and loose bowel movement. The patient self medicated with two Motrin and had some difficulty swallowing. He went to the emergency room and was treated with intramuscular Benadryl 50 mg, and oral ZYRTEC 10 mg. The patient was diagnosed with angioedema after flu vaccination and was observed for two hours. The patient had no wheezing or itchy throat at the time of discharge from the emergency room and was sent home with a 6 day medrol dose pack 5 mg. The swollen lip continued till the next day. At the time of this report, the patient had no symptoms other than feeling tired. Per the reporter the patient recovered; however a recovery date was not reported. Documents held by sender: None.				Y					Y	09/16/2009	09/16/2009	0	None reported	PUB	PUB	Blood pressure medication		The patient had no concurrent illnesses, and was taking blood pressure medication (Trade name and indication not reported) at the time of vaccination on 16 September 2009.		200904031	1						2	Angioedema; Diarrhoea; Dysphagia; Lip swelling; Swollen tongue; Throat irritation; Wheezing; Angioedema; Diarrhoea; Dysphagia; Fatigue; Lip swelling; Swollen tongue; Throat irritation; Wheezing	FLU3~SANOFI PASTEUR~U3194AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U3194A~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0359254	10/05/2009	MA	22.0	22		F	10/05/2009	Rash over entire body. Went to ER given IV, prednisone, Benadryl, Zyrtec. Today is 10-5-09 still has rash - will see PCP.				Y						10/02/2009	10/03/2009	1		UNK	UNK	Nuvaring	none	allergic to penicillin			1						1	Rash generalised	FLUX~UNKNOWN MANUFACTURER~~2~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0359279	10/05/2009	NJ	49.0	49		F	10/02/2009	Patient passed out about 10-15 minutes after being injected with 0.5ml of Fluvirin. 911 was called and EM. personnel took her to Hospital.				Y					U	10/02/2009	10/02/2009	0		OTH	PUB	Unknown	None	Unknown			1						1	Loss of consciousness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359285	10/05/2009	KS	27.0	27		F	10/03/2009	Patient bruised instantly when given shot she also felt dizziness after careful uncertainly she felt fine except her arm was sore.									Y	10/02/2009	10/02/2009	0		OTH	OTH						1						1	Contusion; Dizziness; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359313	10/05/2009	IL	63.0	63		F	10/04/2009	Patient says her throat swelled up and she started coughing about 11 pm. She did not seek medical attention at that time because she could still swallow. She saw her physician on 10/3/09-diagnosed as severe allergic reaction to vaccine-angioedema. She still is coughing up phlegm.				Y					Y	09/25/2009	09/25/2009	0		OTH	UNK		Unknown	Penicillin; Anesthetics			1						1	Angioedema; Cough; Hypersensitivity; Increased upper airway secretion; Pharyngeal oedema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97842P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359315	10/05/2009	TN	48.0	48		M	10/05/2009	Temp greater than 104, inflammatory response hospitalization.				Y	Y	4			Y	09/18/2009	09/18/2009	0	Blood cultures, CT head/chest	OTH	OTH		None	Niacin, TRAZODONE allergies - cardiomyopathy			1						1	Blood culture; Body temperature increased; Computerised tomogram head; Computerised tomogram thorax; Inflammation	FLU3~CSL LIMITED~07649111A~1~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Hospitalisation	Influenza
0359337	10/05/2009	TN	40.0	40		F	10/05/2009	Hard knot redness, size of egg remained for 5 days.									Y	09/28/2009	09/28/2009	0	None	OTH	OTH						1						1	Erythema; Induration; Nodule	FLU3~CSL LIMITED~07649111A~1~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359338	10/05/2009	KY	12.0	12		F	10/05/2009	Friday received Flu vaccine and Sunday talked to Dr because of hives all over her body also complained of sore throat. Dr prescribed prednisone. No resp. symptoms.									Y	10/02/2009	10/04/2009	2	Called family 10/5/09 hives much better	PVT	PVT			Allergy- AUGMENTIN; BACTRIM; Z MAX; PCN; Sulfa; Cephalosporin			1						1	Oropharyngeal pain; Urticaria	FLU3~SANOFI PASTEUR~U3201~6~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359340	10/05/2009	TN	62.0	62		F	09/14/2009	About 5 hours after injection. Site got red and swollen. Very painful. 2 days later-arm still swollen, rash has developed and started to spread down arm towards elbow, pneumo vac site, recommended MD visit.										09/12/2009	09/12/2009	0		OTH	OTH	LIPITOR; Q10; B6; B12					1						1	Injection site erythema; Injection site pain; Injection site rash; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~06274~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359341	10/05/2009	TN	69.0	69		F	09/17/2009	Right arm swelling and redness from injection site and down -size of softball.				Y					U	09/16/2009	09/16/2009	0		OTH	PUB		Cancer				1						1	Erythema; Injection site erythema; Injection site swelling; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0627Y~2~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0359342	10/05/2009	NY	52.0	52		F	10/01/2009	9/8/09- stomach ache, cough. 9/9/09 off balance, lightheaded, weak. 9/10/09 weakness to arms and legs. 9/11/09 - office visit, labs, CXR, UA. 9/12/09 - Emergency room. 9/23 25, 29- office visits, MRI.				Y					N	09/08/2009	09/08/2009	0	Labs WNL; CXR, negative; UA, negative; MRI- neg	PVT	UNK		No				1						1	Abdominal pain upper; Asthenia; Balance disorder; Chest X-ray normal; Cough; Dizziness; Muscular weakness; Nuclear magnetic resonance imaging normal; Urine analysis normal	FLU3~SANOFI PASTEUR~U3189AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359344	10/05/2009	UT	74.0	74		F	09/30/2009	Redness swelling tenderness site of injection. Felt feverish (she'd id not v temp) lasted 3 days.									Y	09/23/2009	09/24/2009	1		PVT	PVT						1						1	Feeling hot; Injection site erythema; Injection site pain; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~1125X~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~97845P2~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359345	10/05/2009	KY	4.0	4		M	09/25/2009	After receiving flu shot (L) arm/(L) shoulder became swollen/tight, red. Progressively worsened over 2 days with redness/swelling/warmth/tightness/pain moving down to area of elbow & nearing (L) shoulder blade MD recommended BENADRYL/MOTRIN/ice for				Y					Y	09/23/2009	09/23/2009	0	Visual assessment	PUB	PUB	None	None	breathing problem when younger - used nebs - out of it			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3186AA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359346	10/05/2009	PA	21.0	21		F	09/29/2009	Felt dizzy and sweaty after she had her flu vaccine. Taken to health service to rest and be observed. Drank sierra mist and ate saltine crackers. Felt better and discharged 45 minutes later. BP% 90/60									Y	09/25/2009	09/25/2009	0	None	OTH	PUB	None	None	None	Fainting~Vaccine not specified (no brand name)~UN~0.00~Patient		1						1	Dizziness; Hyperhidrosis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA278AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0359352	10/05/2009	NM	52.0	52		F	09/29/2009	One hour after shot patient passed out on side of road someone woke her up and she drove to sister (friends) house and passed out again. They took her to ER she was flushed had hives BP 60/30 unconscious.				Y					Y	09/25/2009	09/25/2009	0		OTH	PVT	VIGAMOX opth	Unk	Unk			1						1	Flushing; Hypotension; Loss of consciousness; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~L97842P2~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359354	10/05/2009	OK	56.0	56		F	09/29/2009	1.  Extreme soreness in arm for 2 days beginning within 12 hrs. of shots.  2. Body aches, flu like malaise, slight fever & chills within 36 hrs. of shot tested 24 hrs.									Y	09/08/2009	09/09/2009	1		OTH	PVT	PREVACID;  TYLENOL;  BENADRYL	None	Asthma;  Food & inhalant allergies			1						1	Chills; Influenza like illness; Malaise; Pain; Pain in extremity; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359355	10/05/2009	NV	25.0	25		F	10/01/2009	08-29-09 15:00 heartbeat irregular beats @ regular rate per patient.  Achy body.  Nausea.  09-30-09 17:00 Rash t/o body.  Itchy.  Patient will be treated with PREDNISONE & BENADRYL.										08/29/2009	09/30/2009	32	None	PVT	PVT	BACTRIM X 7 days started 9-22-09.	None	Allergy -> PCN; UTI; S/SX.			1						1	Heart rate irregular; Nausea; Pain; Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUAA68AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0359357	10/05/2009	GA	41.0	41		F	10/05/2009	Redness, swelling, warmth to left deltoid after receiving TDAP and PNEUMOVAX 10/1/09- Reaction did not occur until approx 24 hours later- ran fever 102 24 hours later took analgesics and resolved - area approximately  9 XS left upper arm remains warm.										10/01/2009	10/02/2009	1		UNK	PVT		Denies	Asthma; Diet controlled diabetes; Thyroid			1						1	Injection site erythema; Injection site swelling; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~U3199AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPAB~GLAXOSMITHKLINE BIOLOGICALS~AC52B037AA~UNK~IM~LA~HEP A + HEP B (TWINRIX)~1|PPV~MERCK & CO. INC.~0472Y~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B037AA~1~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0359359	10/05/2009	VA	75.0	75		M		Shot received 8/27/09- 8/29- Severe sweats- Pain in lower butt. Could not sleep prone 9/1- Saw family M.D. - X-rays; Pain meds - Back to M.D. 9/4 - pain progressed to shoulders- whole back- V. severe - 9/9 ER -Bel. pressure mild/saw Spinal specialist- 9/11 -back to family DR. - 9/12 ER - admitted -to host - 9/13 kidneys scan - chem stress test -Aorta test - Neurologist called/Spinal Taps / IGIV - intravenous 5days 9/20-9/24 Diag as GUILLAIN BARRE Syn.  10/7/09 Rehab records received for dates 9/16/09 to 9/28/09. DX: Acute Demyelinating Polyneuropathy, Bells palsy, neuropathy, gait abnormality, CAD, back pain. Recently dx with GBS. Adverse event occured 8/29/09. Presenting SX: Pt c/o prior to admission pt was completely independent with ADL's now presenting with unsteady gait/ataxic gait pattern backpain after receiving influenza vaccine 2 days prior. Assessment: PE neuro (+)numbness, tingling, weakness.  ICD9 codes: 782.0, 351.0, 781.2, 357.0, 724.5, 357.0, 276.1, 401.9, 414.01, V45.82, V14.8, 781.2, 351.0, 272.4, 564.0, 780.93, V12.54, 427.31, V58.61   10/13/09:  Additional Medical Records (Cardiology Consultation) and Discharge Summary received. Date of Service 9/16/09 to 9/28/09 Dx:  Pain and weakness with AIDP/Guillian Barre. Carotid disease bilaterally less than 50%, hyponatremia, dyslipidemia, constipation. Cardiology consult:  Noted hematuria which resolved during hospital course and memory difficulty.  Pt. notes to cardiologist feeling of fatigue and chills.  Decreased breath sounds diffusely, bibasilar rales. 1+ pitting edema RLE.  Positive for focal weakness, sensory change, speech change. Parasthesia of left hand.  Worsening Bell's palsy on the right (patient is unable to close right eye). Decreased fine coordination RUE, hand.  Decreased coordination heel to shin LLE.  Decreased DTR both UE and LLE. Joint pain, myalgias and neck pain all positive.  Pt. treated with 5 doses of IVIG.  Condition at discharge afebrile, ambulating, eating, drinking, voiding and stable.			Y	Y	Y	13	Y	Y	U	08/27/2009	08/29/2009	2	See above.  10/7/09 Rehab records received for dates 9/16/09 to 9/28/09. Diagnostics/Labs: CXR(-), CT chest/abdomen(-), US retroperitoneal(-), EKG (+)A-fib. EKG stress test(-), stress SPECT(-), LP unsuccessful, CT head  remote left cerebellar infarct. MRI head consistent with previous CVA, HCT(L), HGB(H), Carotid artery bilat sono- on right and left less than 50% diameter reduction in the internal carotid artery, bilat antegrade vertebral artery flow, bilat multiphasic subclavian signal. MRI cervical spine-ABN- c5-6 disk/osteophyte deformity. MRI thoracic spine-T8-9 disc bulge w/o cord distortion.  10/13/09:  Additional Medical Records (Cardiology Consultation) and Discharge Summary received. Date of Service 9/16/09 to 9/28/09. Labs and Diagnostics:  Glucose 119 (H), SGOT 45 (H), SGPT 67 (H), Sedimentation Rate 24 (H), PT 28.4 (H), INR 2.96 (H), sodium 127 (L), WBC 3.8 (L), Hgb 12.4 (L), Hct 35.1 (L), MPV 7.3 (L), UA Neg, but with faint growth-UTI, osmolarity of urine 195 (L).  Chloride 96 (L).	MIL	MIL	Lisinopril; Atenolol; Simvastatin; Warfarin/ Aspirin (baby)	Has heart stents/atrial fibrillation	See #18   10/7/09 Rehab records received for dates 9/16/09 to 9/28/09. PMH: Elevated cholesterol, A-Fib, HTN, unspecified arthropathy CVA. Allergy to prednisone. 10/13/09:  Additional Medical Records (Cardiology Consultation) and Discharge Summary received. Date of Service 9/16/09 to 9/28/09 PMH: Hernia repair. heart stents/ atrial fibrillation.			1						1	Back pain; Blood pressure abnormal; Blood product transfusion; Cardiac stress test; Guillain-Barre syndrome; Hyperhidrosis; Lumbar puncture; Musculoskeletal pain; Renal scan	FLU3~CSL LIMITED~07749111A~UNK~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Life Threatening,Hospitalisation,Disabling	Influenza
0359360	10/05/2009	IL	70.0	70		F	09/23/2009	Pt noted symptoms approx 24 hours after injection-localized-redness, tenderness. Swelling to right deltoid. No systemic reaction. Symptoms resolved w/ice. BENADRYL after 2 days.									Y	09/17/2009	09/18/2009	1		PVT	PVT	CLIMARA patch; PROTEGRA; ASA; Glucosamine; Flax seed oil	None	NKDA			1						1	Erythema; Oedema peripheral; Tenderness	FLU3~SANOFI PASTEUR~U3193AA~6~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359361	10/05/2009	IL	78.0	78		F	09/20/2009	Right arm began to hurt around 10:30 AM.  Very painful.  Right arm became rigid with stiffness and pain in shoulders also.  Could not get undressed.  Slept on back & did not move because of extreme pain with sweating (took NAPROXEN 500 mg's).  Finally slept at 4 AM - less pain in AM. (Pain was extreme & frightening).									Y	09/08/2009	09/08/2009	0		OTH	PUB		None				1						1	Hyperhidrosis; Musculoskeletal pain; Musculoskeletal stiffness; Pain in extremity	FLUX~SANOFI PASTEUR~~UNK~UN~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~RA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0359363	10/05/2009	GA	36.0	36		F	10/05/2009	Healthcare worker describes, approx.  8 hrs. post infection, experiencing severe left shoulder pain with difficulty raising left arm above her head, pain with movement of left arm + shoulder, symptoms lasted 72 hrs;  partially resolved with OTC pain med.									Y	09/22/2009	09/22/2009	0		PVT	PVT	SYNTHACID;  CYMBALTA	None	Hypothyroidism			1						1	Injected limb mobility decreased; Musculoskeletal pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA255BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0359364	10/05/2009	TX	65.0	65		U		Patient described numbness with dull/aching pain around injection site starting 2 days after shot.									U	09/29/2009	10/01/2009	2		OTH	PVT		None	None			1						1	Injection site anaesthesia; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98432P1~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359365	10/05/2009	NJ	80.0	80		M	09/27/2009	Pt says arm is still sore and he's having difficulty moving it. Checked pt's arm no bruising no visual problem at am.									U	09/23/2009	09/23/2009	0		OTH	PVT	none		Rotator cuff problems			1						1	Injected limb mobility decreased; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359366	10/05/2009	TX				F	09/28/2009	About 15min after injection given pt stated, she was hot. Pt took BENADRYL supplied by  employer, five min after BENADRYL she c/o trouble breathing. She grabbed employee stated I can't breath - Epi was given (L) arm and called 911. Gave Epi. 3 above site and 2 (R) arm, after injection started convulsing. Lowered to floor w/o injury.  5min after convulsing she regained consciousness, parameds took to hospital awake at time of transport.				Y					Y	09/25/2009	09/25/2009	0		PUB	PVT			DILANTIN, seizure			1						1	Convulsion; Dyspnoea; Feeling hot	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98434P1~UNK~IM~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359367	10/05/2009	VA	4.0	4		F		Right sided facial rash & swelling.  Difficulty breathing swollen eye.  Resolved within 20 minutes after BENADRYL dose.  Pt has multiple food allergies.									Y	09/16/2009	09/16/2009	0		PVT	PVT	SINGULAIR; ZYRTEC; RLOVENT; EPI PEN.	None	Multiple food allergies; shellfish; salmon; eggs; peanuts; seasonal allergies.			1						1	Dyspnoea; Eye swelling; Rash; Swelling face	FLU3~SANOFI PASTEUR~3196AA~4~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359368	10/05/2009	OH	39.0	39		F	09/28/2009	At injection site on left arm pt c/o it swelling, turning red, & hurt.  Pt also c/o fever, chills, & being achy.				Y					Y	09/25/2009	09/26/2009	1		PVT	PVT	MVI; PREM PRO.	None	Migraines; Thrombocytosis; Bone morrow transplant; HTN.			1						1	Chills; Injection site erythema; Injection site pain; Injection site swelling; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U3210AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359369	10/05/2009	OH	45.0	45		F	09/27/2009	Injection given 9/26/09 at about 5:30 pm. Patient called 9-27-09 at about 11 AM saying she had intense itching on legs and was moving up the body. Told her to take 2 BENADRYL and go to ER if it worsens.									U	09/26/2009	09/27/2009	1		OTH	PVT		None	None			1						1	Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359370	10/05/2009	FL	9.0	9		F	09/21/2009	Pt got HEP A & flu vaccine - about 10 min later LOC, fell & hit head on file shelf.  LOC X 3 min, pulse 46-48 O2 100 1/1, BP 100/58 increased pulse to 78 by 5 min.  To ER via ambulance to rule out bleed of brain.  Neuro ok when awake.				Y					Y	09/17/2009	09/17/2009	0	Patient doing well now - CT scan head - normal; EKG - normal.	PVT	PVT	None	None	None			1						1	Computerised tomogram normal; Electrocardiogram normal; Fall; Head injury; Heart rate decreased; Loss of consciousness	FLU3~SANOFI PASTEUR~U3209AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~AHAVB357CA~2~UN~RA~HEP A (VAQTA)~1	USA	Emergency room visit	Influenza
0359371	10/05/2009	GA	74.0	74		M	09/29/2009	1. Very severe difficulty breathing 2. Shivering cold									Y	09/18/2009	09/18/2009	0		OTH	PVT	none	no	no			1						1	Chills; Dyspnoea; Feeling cold	FLU3~SANOFI PASTEUR~U3192AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359373	10/05/2009	NY	81.0	81		M	09/26/2009	Low grade fever & diarrhea - about 1 1/2 weeks after flu shot.									U	09/10/2009	09/17/2009	7		OTH	OTH	SYNTHROID; ZOCOR; DIOVAN.		Unknown			1						1	Diarrhoea; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359374	10/05/2009	FL	80.0	80		F	09/27/2009	Vertigo, nausea, chills, fever.									U	09/21/2009				UNK	UNK						1						1	Chills; Nausea; Pyrexia; Vertigo	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98431P1A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359375	10/05/2009	MD	60.0	60		M	09/29/2009	2 inch bruise and (5) papular bumps over the injection site with soreness at injection site and bruised area.  Starting to fade after 12 days with some tenderness.									U	09/18/2009	09/18/2009	0	None	OTH	PVT	LIROXATRAL;  ATENOLOL	None	None			1						1	Injection site haematoma; Injection site pain; Injection site papule	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359376	10/05/2009	MO	20.0	20		F	09/27/2009	Patient reported vomiting two times, approximately one and two hours after vaccine was administered.  Recommended rest and for patient to see physician.  Patient was monitored for worsening symptoms.									U	09/27/2009	09/27/2009	0		OTH	OTH						1						1	Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P2~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359377	10/05/2009	FL	4.0	4		M	09/28/2009	-Right arm shoulder to elbow swelling and redness, no pain -Right arm small patch of blisters, no pain									Y	09/23/2009	09/23/2009	0	None	PVT	PVT	ULMICORT; Albuterol prn	URI with wheeze (mild)	H/O wheeze with illness			1						1	Injection site erythema; Injection site swelling; Injection site vesicles	DTAP~SANOFI PASTEUR~C2398BA~5~IM~RA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~UT3174HA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~D0413~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~0764Y~2~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0927Y~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0359378	10/05/2009	NY	2.0	2	.6	F	09/26/2009	2 h after flu vaccine administration, rash/hives developed to arm and left side of face.  BENADRYL administered by mother.  Continued BENADRYL dosing every 6 h X 24h.  Symptoms subsided.									Y	09/24/2009	09/24/2009	0		PVT	PVT		None	Peanuts and seasonal allergies			1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~UT3171CA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359379	10/05/2009	RI	36.0	36		F	09/25/2009	Patient became lightheaded and dizzy, she remained seated for 15 minutes after receiving the vaccine and waited for symptoms to reside.  Once she felt better she left.  She was also given a wet cloth to help her symptoms.									Y	09/25/2009	09/25/2009	0		OTH	OTH						1						1	Dizziness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359380	10/05/2009	MO	2.0	2	.2	M	09/25/2009	6x7 in area of erythema edema, & warmth interior to injection site in left thigh.									Y	09/23/2009	09/24/2009	1	None	PVT	PUB						1						1	Injection site erythema; Injection site oedema; Injection site warmth	DTAPIPVHIB~SANOFI PASTEUR~C3428AB~4~UN~RL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~UT3178FA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~D74238~4~UN~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0359381	10/05/2009	AZ	50.0	50		F		Dry mouth, heart palpitations, pt stated BP feels like its going up. Became flushed, pink cheeks paramedics took her to hospital.				Y					U	09/19/2009	09/19/2009	0		PUB	PVT	COUMADIN	None	Penicillin; Valve replacement			1						1	Dry mouth; Flushing; Palpitations	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97847P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359382	10/05/2009	MO	61.0	61		F	09/28/2009	Sore throat, headache, sore muscles, fever 101.1 F, coughing, blowing nose, restless nights, diarrhea.									Y	09/10/2009	09/11/2009	1	None	PUB	PVT	Marcardis HCT 80mg/12.5 mg	None				1						1	Cough; Diarrhoea; Headache; Myalgia; Oropharyngeal pain; Pyrexia; Rhinorrhoea; Sleep disorder	FLU3~SANOFI PASTEUR~U3174FA~1~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359384	10/05/2009	CA	0.24	0	.2	M	09/21/2009	Red area of induration; warm- left deltoid									Y	09/13/2009	09/16/2009	3		PVT	PVT	none	none	none			1						1	Injection site erythema; Injection site induration; Injection site warmth	FLU3~SANOFI PASTEUR~U319YAA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~N2919AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC532B0Y7DA~5~IM~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0359385	10/05/2009	NY	81.0	81		F	09/21/2009	B low grade fever & diarrhea.									U	09/10/2009	09/20/2009	10		OTH	OTH	ADVAIR; ACTOS; EVISTA.					1						1	Diarrhoea; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~07839Y2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359387	10/05/2009	TX	16.0	16		F	09/28/2009	Patient received FLUVIRIN, then approximately, one minute later complained of lightheadedness, she sat down then lost consciousness for approximately 15 seconds, then had seizure like movement, for approximately 5 seconds.  She then slowly woke up.  Paramedics arrived and her vitals were normal.									Y	09/28/2009	09/28/2009	0		OTH	PVT	None	c/o of minor sore throat				1						1	Dizziness; Dyskinesia; Loss of consciousness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359388	10/05/2009	NJ	6.0	6		F	09/25/2009	About 16 hrs after admin of FLUZONE'0910, (L) tight became very large, swollen, erythema, tender, hot - >10 cm induration.									Y	09/22/2009	09/23/2009	1		PVT	PVT		None	None	Same as above~DTaP (no brand name)~4~1.60~Patient		1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3176DA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359389	10/05/2009	MI	44.0	44		F	10/05/2009	Patient received 1 ml IM dose of FLUVIRIN.  Instead of recommended dose of .5 ml.  Patient reports onset of rash on 9/18/09 that has not resolved with topical OTC creams.  Provided referral to clinic for f/u.									U	09/16/2009	09/18/2009	2		PUB	PVT	None	None	Penicillin allergy.			1						1	Incorrect dose administered; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~9783PP1~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359390	10/05/2009	OR	32.0	32		M	10/05/2009	During night after vaccination pt was chilled, couldn't catch breath, arms went numb. Didn't take temp.  Didn't wake wife.  Felt better next morning.  Completely ok after that day.									Y	10/02/2009	10/02/2009	0	None	OTH	PVT	None	None	None			1						1	Dyspnoea; Feeling cold; Hypoaesthesia	FLU3~SANOFI PASTEUR~U3177AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359391	10/05/2009	CA	72.0	72		F	10/04/2009	Patient reported rash around injection site on upper arm.  I instructed her to take BENADRYL every 6 hours and to call her doctor if worsens or not clears completely.									Y	09/29/2009	10/03/2009	4		OTH	OTH	PREDNISONE.	None				1						1	Injection site rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2A~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359393	10/05/2009	FL	42.0	42		F	10/05/2009	Swollen - red - hot- @ site, 5x5 mm hardness. Rx - BACTRIM.				Y					U	10/01/2009	10/02/2009	1	None	PVT	PVT		None	Varicose veins			1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA460AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|TDAP~SANOFI PASTEUR~C303AA~1~IM~RA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0359395	10/05/2009	TX	48.0	48		M	09/18/2009	None stated.										09/18/2009				UNK	UNK						1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U3214AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359396	10/05/2009	OH	54.0	54		F	10/05/2009	- Got chills- body felt drain, swollen in left arm - Redness under arm, headaches, sweating - TYLENOL, diarrhea, vomiting, numbness in face.									N	10/01/2009	10/01/2009	0	No	PVT	PVT	FOLIC ACID-Rheumatoid arthritis 1ml - daily;  METHOTREXATE - slow Arthritis 2.5 mg tablets 3Xtimes;  DICLOFENAC - 50ml inflammatory medicine;  TYLENOL 650mp Pain- nonprescription	No	Rheumatoid Arthritis			1						1	Chills; Diarrhoea; Erythema; Headache; Hyperhidrosis; Hypoaesthesia facial; Oedema peripheral; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0359397	10/05/2009	CA	62.0	62		F	09/28/2009	Swollen throat, passed out, no fever, nausea cold sweat chills sore area x 3 days.									Y	09/16/2009	09/17/2009	1		OTH	PUB	Pt taking PREMARIN	No	No			1						1	Chills; Cold sweat; Loss of consciousness; Nausea; Pain in extremity; Pharyngeal oedema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0632Y~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359400	10/05/2009	OH	54.0	54		M	09/23/2009	Immediately after vaccination, a soft + bump (approximately 1 inch in diameter) appeared at the site of vaccination.  An ice pack was applied for about 5 minutes and when removed, the bump was barely noticeable.  Patient said he felt fine and his arm didn't hurt.									Y	09/23/2009	09/23/2009	0		OTH	PVT	Unknown	Unknown/claimed none	Patient stated none			1						1	Immediate post-injection reaction; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359401	10/05/2009	IL	54.0	54		F	09/11/2009	Patient became light headed/ dizzy and requested ambulance.  EMT came and took her to ER.  Did not receive any (EPI PEN) medication etc at pharmacy where she received vaccine as she just seemed dizzy.				Y					U	09/11/2009	09/11/2009	0		OTH	PUB						1						1	Dizziness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359402	10/05/2009	TX	39.0	39		F	09/29/2009	Complained of pain 9-25-09 but no redness, firmness of area, or swelling; no warmth noted at site, no other symptoms noted or reported  on 9-29-09 redness of area approximately 3 inches in diameter - firm to touch and warm with slight swelling physician ordered Rocephin 500 mg IM, Kenalog 40mg IM and Bactrim OS BID x 7.				Y					U	09/22/2009	09/25/2009	3		PUB	PVT		Rhinitis without Fever	DM, cirrhosis of liver			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3177CA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359404	10/05/2009	PA	19.0	19		F	09/29/2009	Patient complained of spotty vision, dizziness, sweating after getting her flu vaccine. Instructed to lie down. Was taken to health service where she was given liquids to drink. Recovered and discharged in 25 minutes.									Y	09/25/2009	09/25/2009	0	None	OTH	PUB	BCP	None	Allergy to Amoxicillin			1						1	Dizziness; Hyperhidrosis; Visual impairment	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA278AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0359405	10/05/2009	WI	62.0	62		F	09/14/2009	Pain at injection site and going down arm to hand, much better 24 hrs later.									Y	09/09/2009	09/09/2009	0	None	OTH	PVT	Oxycodone/APAP; Ace 10; Vit D 50,000	None	Cephalosporin allergy			1						1	Injection site pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P2~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359408	10/05/2009	NJ	63.0	63		M	09/29/2009	Patient reported a slightly red raised one inch area in diameter at injection site.									U	09/23/2009	09/23/2009	0		OTH	UNK						1						1	Injection site erythema; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359411	10/05/2009	GA	39.0	39		F	09/29/2009	Dizzy, hot, nauseated, intestinal upset, pt reported fever of 99.7 degrees.									Y	09/28/2009	09/29/2009	1		OTH	PVT	SYNTHROID 0.15; PNV; VALTREX 500g		Pregnancy			1						1	Abdominal discomfort; Dizziness; Feeling hot; Nausea; Pyrexia	FLU3~CSL LIMITED~07249111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359412	10/05/2009	IL	66.0	66		M	09/30/2009	Patient was in to pick up an Rx on 9/29/09.  He said that after he received his vaccine last week, he reacted to the pneumonia vaccine.  His arm was swollen, red and very painful.  He went to CDH ER and they diagnosed it as cellulitis from the vaccine and treated.  His arm is now fine.				Y					Y	09/22/2009	09/22/2009	0	Unknown	OTH	PVT	AMLODIPINE 2.5mg;  OMEPRAZOLE 40mg	None				1						1	Erythema; Injection site cellulitis; Oedema peripheral; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~06274~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0359416	10/05/2009	CA	52.0	52		M	09/28/2009	Onset 0925 dizzy, photophobia, decreased blood pressure, positive orthostatic blood pressure with uncompensated heart rate. No chest pain , SOB, hives, tongue swelling, positive nausea txd with PHENERGAN.  VS monitored until stable at 1130 and pt reported feeling better.										09/28/2009	09/28/2009	0		PVT	UNK	PERCOCET; MS CONTIN; Nortriptyline; Cyclobenzeprin; Cyclobenzaprine; Carvedilol; Docusate; Fish oil; ASA; PROTONIX.	None	Allergy to PCN; Bee stings	:Sick X 3 days~Influenza (H1N1) (H1N1 (MONOVALENT) (UNKNOWN))~UN~0.00~Patient		1						1	Blood pressure decreased; Dizziness; Nausea; Orthostatic hypotension; Photophobia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359419	10/05/2009	FL	1.19	1	.2	F	09/22/2009	Slight raised red hives at injection site. Right anterio lateral thigh.									Y	09/21/2009	09/21/2009	0		PVT	PUB						1						1	Injection site erythema; Injection site swelling; Injection site urticaria	DTAPIPVHIB~SANOFI PASTEUR~C3430AA~4~UN~RL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~UT3178EA~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0427Y~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0849Y~2~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0359420	10/05/2009	MI	71.0	71		F	09/29/2009	When she received injection it hurt her arm. She came in a few days after and complained of arm to sore to lift above shoulder. Then she came back and complained of also having tingling in arm.									N	09/11/2009	09/11/2009	0		UNK	UNK						1						1	Injected limb mobility decreased; Injection site induration; Injection site pain; Pain in extremity; Paraesthesia	FLU3~CSL LIMITED~05849111A~UNK~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359422	10/05/2009	GA	0.99	0	1	F	09/28/2009	9/22/09 red raised papular rashes on face trunk which progressed to papulo-vesicular the vesicular & crusting lesions.									U	12/19/2006	09/25/2009	1011		PVT	PVT						1						1	Rash erythematous; Rash papular; Scab	FLU3~SANOFI PASTEUR~UT2176JA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~1025F~1~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~B08691F~4~UN~LA~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~1146F~1~UN~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0359423	10/05/2009	WV	3.0	3		F	09/25/2009	About 1-2 hours after receiving vaccine patient called with description of red spots on right upper arm. No shortness of breath , no palpitations, no tachycardia, no altered mental status. Patient's mom concerned.									Y	09/24/2009	09/24/2009	0		PVT	PUB		None	PENICILLINS		WV0908	1						1	Rash erythematous	FLU3~SANOFI PASTEUR~U3177BA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359424	10/05/2009	KS	35.0	35		F	10/02/2009	Took IM flu vaccine at approx, 1:30 pm. Employee is a counselor. Had client session from 2-3 pm. When came out of session at 3:00 PM, (L) eye was swollen shut, lower (L) side of face swelled later. No resp. problems. Psychiatrist said looks like allergic reaction. Took CLARITIN at 3pm and BENADRYL PO at 6:30pm and 10 pm - Swelling resolved by 9/23 AM and no further problems.									Y	09/22/2009	09/22/2009	0	None	PVT	PVT	Calcium; MVI (doesn't take regularly)	None except allergies	Seasonal nasal allergies - CLARITIN usually daily from August until first			1						1	Eye swelling; Hypersensitivity; Swelling face	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU468AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0359425	10/05/2009	MI	2.0	2	1	M	09/28/2009	Rash developed on face then spread to trunk and limbs pt took BENADRYL with no relief of sx-rash began about 24 hours after receiving influenza vaccine. RX- watch and wait.									U	09/23/2009	09/24/2009	1		PVT	PVT	BENADRYL PRN	None	None			1						1	Rash	FLU3~SANOFI PASTEUR~U3208AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359426	10/05/2009	MN	89.0	89		F	09/15/2009	Local, injection site reaction resulting in a 3-4 inch bruise surrounding injection site beginning night of vaccination. No allergic reaction reported. No other adverse effects  reported and hospitalization was not necessary.									Y	09/11/2009	09/11/2009	0		OTH	OTH						1						1	Injection site haematoma; Injection site reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359427	10/05/2009	NY	86.0	86		F	09/28/2009	Rec'd influenza vaccine 9/21, broke out in rash on neck 9/27, only on (L) side of neck shoulder (1 week after FLUVIRIN, w/o reaction to any flu imm. in past).									Y	09/21/2009	09/27/2009	6		UNK	PUB	DIOVAN, METOPROLOL, NIASPAN, ACTOS, OMEPRAZOLE, SERTRALINE, CALCIUM	Not ill	Diabetes, HTN; allergic to codeine & LOTREL	rash~Influenza (Seasonal) (Fluvirin)~1~86.00~Patient		1						1	No reaction on previous exposure to drug; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359428	10/05/2009	NJ	91.0	91		M	09/28/2009	Patient is reporting dizziness.									U	09/25/2009	09/25/2009	0		OTH	OTH		None	None			1						1	Dizziness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359429	10/05/2009	MO	28.0	28		M	10/05/2009	This case was reported by a healthcare professional and described the occurrence of itching in a 28-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline).  The subject's medical history included seasonal allergy. On 30 September 2009 at 09:30 the subject received unspecified dose of FLULAVAL (unknown, left arm).  On 30 September 2009, less than one day after vaccination with FLULAVAL, the subject experienced itching, erythema and inappropriate route of vaccination.  It was reported the nurse inadvertently gave vaccine intradermally and the subject reported itching and redness.  The healthcare professional considered the events were disabling.  At the time of reporting the erythema and itching were unresolved.  The healthcare professional considered the events were probably related to vaccination with FLULAVAL.								Y	N	09/30/2009	09/30/2009	0	UNK	OTH	OTH		Unknown	Seasonal Allergy; Concomitant medications were unknown. The subject had previously received influenza vaccinations and no adverse events were reported. No adverse events were reported following receipt of prior immunizations.		A0810057A	1						1	Erythema; Incorrect route of drug administration; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA279AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Disabling	Influenza
0359437	10/05/2009	AZ	68.0	68		F	09/30/2009	Initial report received on 21 September 2009 from a health care professional. This case is part of a cluster of two patients from the same reporter. The other patient's information is reported in case 2009-03998. A 68-year-old female patient, who denied any concurrent illnesses, who had no known allergies, but has medical conditions of increased cholesterol, increased blood pressure and migraines, had received a dose of FLUZONE SV 2009-2010 (lot number U3198AA) on 04 September 2009. The route and site of administration and number of previous dose were not reported. Three days post-vaccination, the patient experienced dizziness and was evaluated by a physician and treated with Meclizine. The dizziness lasted at least 24 hours. The recovery status of the patient was unknown. Documents held by sender: None.				Y					U	09/04/2009	09/07/2009	3	Not reported	OTH	OTH	LISINOPRIL; SIMVASTATIN; ATENDRONATE; VITAMIN A		The patient denied any concurrent illnesses and has no known allergies and medical conditions of increased cholesterol, increased blood pressure and migraines.		200903999	1						1	Dizziness	FLU3~SANOFI PASTEUR~U3198A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359438	10/05/2009					M	10/01/2009	Initial report was received on 22 September 2009 from another manufacturer (document number 45225402) who received the report from a consumer, who is the patient's parent. A male patient (age not reported) had received an Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported). According to the reporter, her son had a reaction to the flu vaccine and experienced seizures afterwards. The patient's recovery status was not reported. The reporter declined to provide contact information and no additional information was provided. Documents held by sender: None.				Y					U				Not reported	UNK	UNK			Not reported		200904036	1						1	Convulsion; Immunisation reaction	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0359439	10/05/2009	CA				F	10/01/2009	Initial case received from a consumer, who is also the patient, on 22 September 2009. A female patient with no reported medical history received a flu vaccine (manufacturer, lot number, and date of administration not reported) and subsequently developed GUILLAIN BARRE syndrome. Treatment included cortisone and per the patient she later developed cataracts and diabetes. No additional information was reported. Documents held by sender: None.				Y					U					UNK	UNK			Not reported.		200904037	1						1	Cataract; Diabetes mellitus; Guillain-Barre syndrome	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0359442	10/05/2009	GA	3.0	3		M	09/29/2009	Initial report received on 21 September 2009 from a health care professional. A three year old patient with no reported past medical history developed GUILLAIN BARRE Syndrome 34 days after receiving FLUZONE 2009-2010 (lot number U3189AA) intramuscularly in the left deltoid on 17 August 2009 during a check up visit. On 18 September 2009 and 19 September 2009 the patient returned to the physician's office with complaints of leg pain and weakness. On 20 September 2009 the patient was diagnosed with GUILLAIN BARRE Syndrome. As a result, the patient was hospitalized for two days and received intravenous immunoglobulin G (IV IgG). The patient did not recover. No further information was provided. List of Documents held by Sender: none.  10/28/09:  Hospital records and discharge summary received for dates of service 9/19/09 to 9/24/09.  Final Dx:  Guillain-Barre Syndrome, Peripheral Neuritis, Back pain.  Assessment:  Admitted for worsening back pain, leg pain and weakness following a viral illness two weeks prior and flu vaccine 1 month prior.  MRI-abnormal; consistent with neuritis. IVIG administered over 4 days. Developed urinary retention and distension described as hydroureternephrosis,  requiring a foley catheter.   Voiding on own for 24 hours prior to discharge.  Discharged on Neurontin and scheduled to follow up with rehabilitation service on 9/29/09.					Y				N	08/17/2009	09/20/2009	34	not reported. 10/28/09:  Hospital records and discharge summary received for dates of service 9/19/09 to 9/24/09.  Labs and diagnostics:  MRI: Vigorous smooth enhancement of the nerve root, filum terminale;  consistent with neuritis. CSF-1 WBC, 0 RBC, 187 Protein, 55 Glucose.  UA-Negative. CBC-Segs 50.6 (H), Lymph 39.8 (L), Mono. 6.2 (H).	PVT	UNK			No known allergies. 10/28/09:  Hospital records and discharge summary received for dates of service 9/19/09 to 9/24/09.  PMH:  Viral illness.		200903997	1						1	Blood product transfusion; Guillain-Barre syndrome; Muscular weakness; Pain in extremity	FLU3~SANOFI PASTEUR~U3189A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0359443	10/05/2009	AZ	86.0	86		M	09/29/2009	Initial report received on 21 September 2009 from a health care professional. This case is one of a cluster of two cases from the same reporter. The other patient is reported in case 2009-03999. An 86-year-old male patient, who denied any concurrent illnesses, who is allergic to ace inhibitors and has medical conditions of diabetes, increased blood pressure and increased cholesterol, had received a dose of FLUZONE SV 2009-2010 (lot number U3198AA) on 14 September 2009. The route and site of administration and number of previous doses were not reported. The patient denied having received any other vaccines that day. Concomitant medications included Amlodipine, PLAVIX, Metformin, ZOCOR and ASA. Four days post-vaccination, the patient complained of dizziness that caused him to be bedridden. His physician made a house call and treated the patient with Compazine and meclizine. The dizziness lasted at least 24 hours; however the reporter was unsure if the dizziness had resolved completely. Documents held by sender: None.				Y				Y	U	09/14/2009	09/18/2009	4	Not reported	PVT	OTH	Amlodipine; Metformin; PLAVIX; ZOCOR; ASA		The patient denied any current illnesses; and has allergy to ace inhibitors and medical conditions of diabetes, increased blood pressure and increased cholesterol. The patient denied receiving any other vaccines on 14 September 2009.		200903998	1						1	Bedridden; Dizziness	FLU3~SANOFI PASTEUR~U3198A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0359448	10/05/2009	IL				U		Pt reported in person to pharmacy and showed RPh swollen arm and reddening below site of injection. No itchy pain or SOB. Patient advised to seek medical attention.									U					UNK	PVT						1						1	Injection site erythema; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~978P16~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~6274~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359451	10/05/2009	OR	75.0	75		F	10/15/2009	Right arm swelling from flu shot given on 10-2-09. Pt given a brace for  (R) arm.				Y					U	10/02/2009	10/03/2009	1		PVT	PVT		None	None			1						1	Oedema peripheral	FLU3~CSL LIMITED~057491114~4~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0359452	10/05/2009	MN	28.0	28		F	10/15/2009	Profound myalgias with high CPK. Weakness.  10/13/09 Medical records received.  Dates of Service 9/28/09 to 9/30/09.  Assessment:  Polymyositis. Patient presented with a 4 day history of profound body aches, chills, fever as high as 102-103, mild cough, muscle pain and weakness, fatigue, nausea and some shortness of breath.  The onset of symptoms was the night she received her influenza vaccine.  Started on prednisone are scheduled to return to clinic in two days.  Pt. diagnosed with polymyositis probably due to the influenza vaccine.  Upon return to clinic pt. was dramatically improved, pain was improved, she still had some fatigability with lots of effort, her cough was gone and she denied any additional symptomology.  Pt. to follow up with any additional concerns.									Y	09/24/2009	09/24/2009	0	10/13/09 Medical records received.  Dates of Service 9/28/09 to 9/30/09.  Labs and Diagnostics:  9/28/09:Chest X-Ray-Normal, CPK 2989 (H), MCV 84.7 (L), UA Trace Leukocytes (H),  9/30/09: CPK 1639 (H)	PVT	PVT	RITALIN; WELBUTRIN		BACTRIM; Amoxicillin.  10/13/09 Medical records received.  Dates of Service 9/28/09 to 9/30/09.  PMH:  Asthma, ADHD, depression, allergies to bactrim and amoxicillin.			1						1	Asthenia; Myalgia	FLU3~SANOFI PASTEUR~U3196AA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359453	10/05/2009	ID	41.0	41		F	10/05/2009	Hives evening of 09/30/09 and 10/01/09 took BEANDRYL and only had problems occur in the evening.									Y	09/30/2009	09/30/2009	0		PVT	PVT		None	Allergic to several things Pt. did not specify			1						1	Urticaria	FLU3~SANOFI PASTEUR~U3198AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359457	10/05/2009	CA	57.0	57		F		Intense shoulder pain, requiring an emergency room visit, a doctor's office visit. Physical therapy, cortisone injection and acupuncture. I still have the pain. I cannot move my arm behind my back.				Y					N	10/09/2008	10/09/2008	0		OTH	PVT		None	Nothing unusual			1						1	Injected limb mobility decreased; Musculoskeletal pain	FLU3~SANOFI PASTEUR~U2768AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359458	10/05/2009	OH	34.0	34		F	10/05/2009	swollen lips, shortness of breath									Y	10/01/2009	10/01/2009	0		PUB	PVT		no	Pregnant			1						1	Dyspnoea; Lip swelling	FLU3~SANOFI PASTEUR~U3186AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHBVB761AA~3~IM~RA~HEP B (ENGERIX-B)~1	USA		Influenza
0359462	10/05/2009	MA	73.0	73		F	10/05/2009	Dark red area at injection site  Severe headache - has taken tylenol 10/05/2009 still has slight headache, redness has faded at injection site									N	10/02/2009	10/03/2009	1		PUB	PUB		Redness around the injection site:  Dark red Severe headached top of head to neck area	Has allergies.  Never had a reaction before			1						1	Headache; Injection site erythema	FLU3~SANOFI PASTEUR~U3185AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359463	10/05/2009	CA	61.0	61		F	10/05/2009	High Fever, Dysentary, Vomiting, Malaise									U	09/23/2009	09/30/2009	7		UNK	UNK		no	no			1						1	Dysentery; Malaise; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359464	10/05/2009	LA	40.0	40		F	10/05/2009	While asleep, rolled onto Left side and was awaken with tingling down Left arm. Tingling remained 9/30 and was seen by physician. No treatment recommended.  Neuropathic sensations resolved completely 10/03/09				Y					Y	09/29/2009	09/30/2009	1	None	PUB	PUB	None	None	None			1						1	Paraesthesia	FLU3~SANOFI PASTEUR~U3173CA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359465	10/05/2009	DC	44.0	53		F	10/05/2009	redness, itching, swollen and warm to touch at injection site									Y	09/29/2009	09/30/2009	1		UNK	PVT		none	allergy to PCN,hypothyroid			1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua470ba~7+~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0359466	10/05/2009	IL	37.0	37		F	10/05/2009	Started coughing and couldn't stop.  Throat swelling and mouth swelling.  Hard to breathe.  By 2 AM feeling better and fell asleep									Y	10/01/2009	10/01/2009	0		PUB	PVT	Hydroxyzine as needed, fexofenadine 180 mg twice daily, cimetidine 300 mg twice daily and doxepin at bedtime 10 mg.  Regular vitamins and coral calcium	Currently being treated for hives.	Currently being treated for hives			1						1	Cough; Dyspnoea; Oedema mouth; Pharyngeal oedema	FLUX~UNKNOWN MANUFACTURER~~5~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359468	10/05/2009	SC	0.92	0	.9	F	10/05/2009	firm papules noted to left thigh									Y	10/02/2009	10/02/2009	0	no test performed	PVT	PUB		tinea corporis				1						1	Injection site papule	FLU3~SANOFI PASTEUR~u3188aa~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359469	10/05/2009	IA	50.0	50		F	10/05/2009	The trotts									U	10/02/2009	10/05/2009	3	NA	PUB	PVT	NONE	NO	Fine			1						1	Diarrhoea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~9721501~5~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359470	10/05/2009	FL	30.0	30		M	10/05/2009	Viral Labyrinthitis				Y					Y	09/25/2009	09/29/2009	4		MIL	MIL	Lisinopril, 20mg daily	No	Hypertension			1						1	Viral labyrinthitis	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0359472	10/05/2009	MD	28.0	28		F	10/05/2009	sore throat, fever, malaise; later, violent unproductive and constant cough. Support medications given by doctor (Albuterol, Symbicort, Robitussin AC). Patient is has been ill the entire time since then, but fever has receded since 10/01/2009				Y					U	09/22/2009	09/25/2009	3		PVT	UNK		No illnesses	avocado, latex, asthma			1						1	Cough; Malaise; Oropharyngeal pain; Pyrexia	FLU3~CSL LIMITED~~UNK~~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0359473	10/05/2009	CA	51.0	51		F	10/05/2009	12:15 PM Went outside walking up steep steps, noticed shortness of breath, continued to get worse, began coughing, felt irritation in throat, chest tightness, not getting enough air. Eyes started getting red. 3:15 PM continued to feel funny left meeting early and went to E.R.  Never had flu vaccine before. No other vaccine given or in last 4 weeks. No medications taken day of vaccine.				Y					Y	09/22/2009	09/22/2009	0	CXR, EKG, normal.  O2 sats taken patient state they were low , but doesn't know result.	UNK	PUB	None	None	Childhood Asthma			1						1	Chest X-ray normal; Chest discomfort; Cough; Dyspnoea; Electrocardiogram normal; Feeling abnormal; Ocular hyperaemia; Oxygen saturation decreased; Throat irritation	FLU3~SANOFI PASTEUR~03196AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359475	10/05/2009	MT	38.0	38		M	10/05/2009	Entire right bicep is red, hot & itchy.  Pt denies SOB or difficulty breathing.  Pt presented to ED on 10/05/09 @ 1100.  Given Benadryl 50mg IM.				Y						10/02/2009	10/04/2009	2		MIL	MIL						1						1	Injection site erythema; Injection site pruritus; Injection site warmth	ANTH~EMERGENT BIOSOLUTIONS~FAV017~6~IM~RA~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500711P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U2917AA~UNK~IM~~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA	Emergency room visit	Influenza
0359478	10/05/2009	ME	9.0	9		M	10/05/2009	Parent contacted school to excuse student due to illness.  Fever, headache, and runny nose reported by parent.									N	10/02/2009	10/05/2009	3		UNK	UNK		None noted	N/A			1						1	Headache; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0359482	10/05/2009	MO	64.0	64		M	10/05/2009	Injection was given in the left joint area of the shoulder. Woke up the next morning experiencing sharp pains in the shoulder joint and running down the muscle to the elbow. It is more painful to lift my arm up and when I don't move it at all. Today is October 5 and I am still experiencing the same kind of pain.The pain still as severe as it was the day after I received the shot.									U	09/28/2009	09/29/2009	1		UNK	PVT		None	None			1						1	Arthralgia; Injected limb mobility decreased; Myalgia; Pain in extremity; Wrong technique in drug usage process	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0359483	10/05/2009	CA	55.0	55		F	10/05/2009	Felt like a golf ball, tightness was in her throat, aproximately 3.5 hours after vaccination, red, painful,itchy eyes. Went home at 4pm, felt funny, couldn't take deep breaths. Went to bed at 4pm, woke up at approximately 7pm and had a fever of 100.5, tightness in throat had lessened at that time									Y	09/23/2009	09/23/2009	0	none	PUB	PUB	none	None	None			1						1	Dyspnoea; Eye pain; Eye pruritus; Feeling abnormal; Ocular hyperaemia; Pyrexia; Throat tightness	FLU3~SANOFI PASTEUR~03186AA~2~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359484	10/05/2009	TX	25.0	25		M	10/05/2009	Patient was being  seen  by  Dr with cough,  congestion, fever weakness x 2 days. Medical  assistant gave  flu vaccine  with  no  MD  order. The  Dr had  ordered  the  rapid BinaxNow test. No negative outcome, no  adverse reaction  noted.									Y	10/01/2009	10/01/2009	0	Binax Now Influenza A & B rapid  test result- Negative   completed here  at  the  clinic.	UNK	UNK		cough,  congestion,  weakness, fever	Asthma			1						1	Influenza serology negative; No adverse event; Vaccination error	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA265AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0359485	10/05/2009	ND	59.0	59		F	10/05/2009	Acute dyspnea, double vision, progressive muscle weakness leading to mechanical ventilation on 09/30/2009.  Suspect Guillain Barre syndrome vs Miller Fisher syndrome.  She is now on mechanical vent.  10/19/09 Hospital DC summary received service dates 9/30/09 to 10/11/09. Assessment: Acute polyneuropathy/Guillain-Barre Syndrome. Patient presents with hx of 5-10 days of progressive tightness (chest), double vision, confusion, shortness of breath. Respiratory arrest in radiology suite. Intubated, mechanical ventilation. Significant weakness of all extremities, unable to open eyes due to ptosis. IVIG. Plamapheresis. PEG tube. Abdominal Distension. Bowel sounds absent. Malnourished. Chills. Transferred to another facilty. 10/29/09:  Lab Results and Neurology notes received for dates of service 10/12/09 to 10/28/09. Dx:  Placid, areflexic quadriparesis with facial diplegia and opthalmoparesis, neuromuscular respiratory failure, s/p traheostomy and PEG Tube placement. Septic shock, ventilator associated pneumonia.  Ileus.  Large bilateral pleural effusion, anemia. Hypokalemia.  Assessment:  Movement of left wrist and right thigh.  Ciprofloxacin for UTI.  Plasma exchange. Febrile with temp up to 38.6.  Oxygen desaturation.   Tolerating tube feeds. Thorocentesis to drain pulmonary effusion.			Y	Y	Y		Y		U	09/24/2009	09/29/2009	5	10/19/09 Hospital DC summary received service dates 9/30/09 to 10/11/09. LABS and DIAGNOSTICS: MRI Brain - Abnormal, nonspecific demyelinating lesions. ANA (+). Anti-SSA Antibody (Sjogrens) (+). CT abdomen - Abnormal, adynamic ileus. Abdominal X-ray - Abnormal - ileus. Chest X-ray - Abnormal, bilateral infiltrates upper lobes. EMG/NCS - Abnormal, consistant with Guillain-Barre syndrome. PTT 26, PT 10.1, INR 0.9. CBC - WBC 11.6 HGB 10.4 HCT 30.4 Platelets 190. CHEM - Sodium 143 Potassium 3.8 Chloride 112 Bicarbonate 25 BUN 19 Creatinine 0.5 ALT 22 AST 28 Magnesium 2.4 Phosphorus 2.8. CSF - Protein 31 Glucose 62.  10/29/09:  Lab Results and Neurology notes received for dates of service 10/12/09 to 10/28/09.  Labs and diagnostics:  Hgb 7.7 (L), Hct 22.9 (L), Erythrocytes 2.85 (L), Leukocytes 11.3 (H), Platelets 115 (L), Monocytes 0.29 (L), Sodium 133 (L), Potassium 3.1 (L), Glucose 167 (H), ABG:   PCO2 49 (H), HCO3 28 (H), PO2 55 (L), Ph 7.45 (H).  MRI Brain-Abnormal.  KUB-Normal.  EMG-Consistent with GBS.  ANA-Negative, Serology for Sjogren's-Negative.  Tracheal culture Positive-Klebsiella, Urine culture Positive-E. coli.  CXR-Pleural effusion.	UNK	UNK		None	Hypothyroid, Hypertension, Hyperdyslipdemia. Allergy hypocholorthiazide. 10/29/09:  Lab Results and Neurology notes received for dates of service 10/12/09 to 10/28/09.  None.			1						1	Diplopia; Dyspnoea; Guillain-Barre syndrome; Mechanical ventilation; Miller Fisher syndrome; Muscular weakness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA261AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening,Hospitalisation	Influenza
0359486	10/05/2009	MN	24.0	24		F	10/05/2009	Hives									Y	09/29/2009	09/29/2009	0		PVT	PVT		None	Sulfa, Ceftin, Cats			1						1	Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA476BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0359487	10/05/2009	CA	62.0	62		M	10/05/2009	It felt like a low grade flu, with all the symptoms, fever, headache, stomach upset, diarrhea.  This lasted for a little over 24 hours.  Next day felt weak but much better.									Y	10/01/2009	10/03/2009	2	None	UNK	UNK		NOne	None			1						1	Abdominal discomfort; Asthenia; Diarrhoea; Headache; Influenza like illness; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359489	10/05/2009	MD	8.0	8		M	10/05/2009	Mom states patient awakened with c/o of ithy legs-Mom observed welts on legs & a few on back & abdomen-she gave 25 mg Benadryl and had patient take a shower s/s resolved in 1/2hr. Patient went to school-Mom received a call from school nurse around 2pm stating welts had returned and she had administered Benadryl- Mom p/u patient and took him to pediatrician. Mom states Benadryl took longer to work this time. per Mom Dr. placed patient on Benadryl every 5 hours until s/s resolve. Mom states patient is allergic to eggs (parent did not disclose on consent) but has received flu shot every year without incident.									Y	09/15/2009	09/16/2009	1		UNK	UNK		None	Asthma, Egg allergy, Peanut allergy			1						1	No reaction on previous exposure to drug; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U3208AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359490	10/05/2009	KY	36.0	36		F	10/05/2009	Excessive bleeding several days after vaccine administered									Y	09/01/2009				MIL	OTH		No	hypothyroidism			1						1	Haemorrhage	FLU3~CSL LIMITED~~UNK~~~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359493	10/05/2009	CA	46.0	46		F	10/05/2009	Dizziness, fast heart rate, nausea, fatigue Call Kaiser they said not to worry about the severe reaction.									Y	10/03/2009	10/03/2009	0		PVT	PVT		No	No			1						1	Dizziness; Fatigue; Heart rate increased; Nausea	FLUX~UNKNOWN MANUFACTURER~~2~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359496	10/05/2009	TN	51.0	51		M	10/05/2009	numbness in left arm and weakness of the left arm followed by neck pain. Within 2 days it has progressed to quadraparesis. CSF showed Protein 81, normal glucose and 5 WBC 11/24/2009 MR, Consult records, DC summary for 10/3-10/15/2009.  DC DX: C3-7 transverse myelitis Patient with c/o's numbness/tingling in bilateral UE's, lt worse than rt, progressing to bilateral LE weakness, neck pain and bladder dysfunction. LP,  Tx: plasmapheresis, IV steroids, PT. ICD-9 codes: 341.22, 344.04, 599.o, 596.54, 272.4, 300.0, 530.81, 300.01, 722.52, 041.19, 272.0, 276.8, 787.6, 564.00, 287.5, 788.20, 788.60			Y	Y	Y	12				09/24/2009	10/02/2009	8	MRI C spine showed enhancing T2 lesion at C3 to C7. CSF as above. further results pending. Labs: CBC, CMP, RA factor, Anti-DNA, blood, urine and csf cultures, ESR, CRP all normal/negative, Vit B12 high, ANA + at 1:160 Dx studies: MRI brain negative, MRI C-spine abnormal, noting an enhancing lesion C3-C7	UNK	UNK		No	No PMH: GERD, Anxiety, Hyperlipidemia Allergies: NKDA			1						1	CSF glucose normal; CSF protein increased; CSF white blood cell count increased; Hypoaesthesia; Muscular weakness; Neck pain; Nuclear magnetic resonance imaging abnormal; Quadriparesis	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Life Threatening,Hospitalisation	Influenza
0359497	10/05/2009	NY	6.0	6		F	10/05/2009	muscle cramps in thighs									U	09/28/2009	09/30/2009	2	WBC 9.0 ESR 22 CPK 39 ASO pending	PVT	PVT	Motrin	no	Omnicef, Augmentin allergy in past			1						1	Blood creatine phosphokinase increased; Laboratory test; Muscle spasms; Red blood cell sedimentation rate increased; White blood cell count normal	FLUN3~MEDIMMUNE VACCINES, INC.~500715P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0359501	10/05/2009	VA	42.0	42		F	10/05/2009	I started with red hives.  Three hours later they turned in to bright red masses all over my chest and back.  Very itchy everywhere. By the next morning I had a red rash all over my whole body even my feet,hands and neck and face.  My fingers and toes swelled like hotdogs.  My skin felt like it was on fire it was literally hot to the touch but I didn't have a fever.  It also felt like I had a bad sunburn to touch.  I went to the Dr. and she prescribed Benadryl and Prednesone (sp?) Sorry I am not where the bottle is for correct spelling. It is now 10/05/2009 I have been on the sertoids since Friday and I am still having sypmtoms and I am still very itchy. It itches deep under my skin.  I don't have a visible rash anymore.									Y	09/28/2009	10/01/2009	3		UNK	PVT		none	very mild asthma under complete control			1						1	Erythema; Oedema peripheral; Pruritus generalised; Rash generalised; Skin burning sensation; Skin warm; Urticaria; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848P1C~1~ID~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848P1C~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0359504	10/05/2009	VA	56.0	56		F	10/05/2009	FIRST let me say both my doctor and I do not feel my illness was related to the flu shot but I am reporting it only because it was so close to the time of my vaccination.... High fever  104 oral  Nausea & vomiting for 5 hours  temp down to 101 by 2 am after ASA and tylenol   Called ambulance and was admitted to hospital with pnemonia bilaterally  pulse ox 90  difficulty breathing... 10/19/09 Discharge summary and hospital records received for dates 9/22/09 to 9/24/09.  DC DX: pneumonia. Presenting SX: Pt. seen by PCP with c/o difficulty urinating, frequency, burning. PCP gave abx, pt started abx 2 days later when fever developed along with shortness of breath, cough. Pt was admitted. Assessment: O2 sat 90% diagnostics performed, IV abx given. Pt improved and DC home. Follow: I want to make sure you know that I filed this report on the advice of my doctor only to be informative to you. Neither she nor I feel that my illness was at all related to the flu shot I received that day. Just as a precaution I filed the VAERS form but in fact it is most likely NOT a Reaction to the shot but just a coincidence that I look ill suddenly hours after the injection.				Y	Y	3				09/20/2009	09/20/2009	0	lungs still recovering...   again  most likely not related to the flu shot...  I also had minor surgery on my mouth(gums) at 3:00 that day after the flu shot before the pneumonia... also probably not related to the pneumonia or flu shot... just as a precaution am reporting it. 10/19/09 Discharge summary and hospital records received for dates 9/22/09 to 9/24/09 Diagnostics/Labs: CXR abnormal- bilateral infiltrates, CT abdomen/pelvis abnormal-diverticulosis, midline ventral hernia, fatty liver, WBC 13.28(H), HGB 11.5(L), HCT 34.9(L), RDW 15.8(H), alk phos 78(L), UA (+)Leukocytes, blood cx(-).	UNK	UNK	I get the flu shot every year and have had the pneumonia vaccine too...never had any reaction   got tetanus a couple years ago too with no adverse reaction.. I think this pneumonia is coicindence to the flu shot day...not really related.  I	bladder infection	allergy to sulfa  and bee stings    medical conditions = Asthma, insulin dependent diabetes, degenerative joint disease, migraines, hypothyroidism, depression, osteoporosis, peripheral neuropathy, urinary incontinence, 10/19/09 Discharge summary and hospital records received for dates 9/22/09 to 9/24/09 PMH: Asthma, HTN, obesity, gastric bypass, osteoarthritis, IDDM, hypothyroidism, diabetic neuropathy.			1						1	Dyspnoea; Nausea; Oxygen saturation decreased; Pneumonia; Pyrexia; Vomiting	FLU3~CSL LIMITED~813-09-07049111~2~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Hospitalisation	Influenza
0359505	10/05/2009	NC	24.0	24		F	10/05/2009	SOB, difficulty breathing, wheezing, coughing, burning sensation in throat				Y					Y	10/02/2009	10/02/2009	0	None	PUB	UNK		None	None			1						1	Cough; Dyspnoea; Throat irritation; Wheezing	FLUX~UNKNOWN MANUFACTURER~~1~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0359507	10/05/2009	CA	43.0	43		F	10/05/2009	Hives on the front neck, itching.										10/02/2009	10/05/2009	3		UNK	UNK		no	no			1						1	Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359512	10/05/2009	LA	55.0	55		F	09/24/2009	Immediate swelling at injection site w/ bruising.									Y	09/24/2009	09/24/2009	0		OTH	PVT	Unknown	None	Unknown			1						1	Immediate post-injection reaction; Injection site haematoma; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359513	10/05/2009	CA	42.0	42		M	10/05/2009	Patient reported itchiness at injection site that spread moving down left arm. No swelling noted redness noted down left arm to hand. Pt continued to report itchiness. Pt treated with BENADRYL 50mg/ml IM right deltoid at 10:56 am by PHN.									Y	09/30/2009	09/30/2009	0		PUB	PUB		None	NKDA			1						1	Injection site erythema; Injection site pruritus	FLU3~SANOFI PASTEUR~V3186AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359516	10/05/2009	MO	5.0	5		M		Redness and swelling at injection site. Tx: BENADRYL									U	10/01/2009	10/01/2009	0		PVT	OTH		None	None			1						1	Injection site erythema; Injection site swelling	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~SPAC20B115AA~1~UN~LA~DTAP + IPV (KINRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500688P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~MERCK & CO. INC.~0563Y~2~UN~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0978Y~2~UN~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0359518	10/05/2009	WI	57.0	57		F	10/05/2009	started with red rash (looked like mosquito bites) on (L) arm 2 days after received shot. Spread to (R) arm, to abdomen then to back and (L) leg. Saw MD for different issue & addressed rash. MD recommended HYDROCORTISONE cream & BENADRYL as needed. Rash started lessening on 10/3/09.				Y					Y	09/25/2009	09/27/2009	2	None	OTH	PVT	CELEBREX, PROZAC, CHLORAZEPAN	None	None			1						1	Rash erythematous	FLU3~CSL LIMITED~01749211A~7+~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0359521	10/05/2009	IL	55.0	55		F	09/21/2009	930 AM - Injection. 11 AM - Cough dry. 1 PM - Increased congestion. 3 PM - Wheezing - headache - overall body ache.									Y	09/14/2009	09/14/2009	0	None	OTH	UNK	None	None	None			1						1	Cough; Headache; Pain; Respiratory tract congestion; Wheezing	FLU3~CSL LIMITED~07949111A~UNK~UN~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0277174	10/06/2009		2.0			F	08/25/2009	This case was extracted from the VAERS database via QSCAN on 11 March 2009 (VAERS identification number 277174). A two-year-old female patient whose medical history was not reported, had received on 29 December 2006 a first intramuscular injection of FLUZONE No Preservative '2006-'2007 (lot number U2191CA); a third intramuscular injection of TRIPEDIA (lot number U1857CA); a first intramuscular injection of HAVRIX (manufacturer GlaxoSmithKline, lot number AHAVB130AA); and a third intramuscular injection of PREVNAR (manufacturer Wyeth, lot number B08657C). The sites of administration were not reported for any of the vaccines. Around 20:00 pm or 21:00 pm on 29 December 2006, the patient developed a temperature of 102.4 degrees Fahrenheit and was irritable. Approximately seven days later, she experienced a severe diffuse cough and she had a earache, nausea and vomiting. The patient had been evaluated by a physician (date not reported) and was treated with nebulizer treatments on an outpatient basis without improvement. On 08 January 2007 the patient was hospitalized and diagnosed with flu and bronchitis. Temperature on admission was 100.8 degrees Fahrenheit and physical examination revealed a respiratory rate of 32 breaths per minute with wheezing and rhonchi in the lung fields. The patient was treated with intravenous antibiotics and nebulizer treatments. It was noted the patient was also treated for bacterial appearing conjunctivitis. Diagnostic tests included a viral wash that was positive for influenza Type B, a negative RSV (respiratory syncytial virus) test, a sedimentation rate (SED rate) of 28, a CBC (complete blood count) that had a left shift, a negative blood culture and sensitivity test, and a negative chest x-ray. The patient experienced resolution of the wheezing at the time of discharge, but the cough continued. The patient was discharged on day four of hospitalization which was on 11 January 2007. At that time, the patient was discharged on continued nebulizer treatments, cough medications and oral antibiotics. Final diagnosis at discharge was community-acquired pneumonia, allergic bronchoasthma, respiratory distress, conjunctivitis, and acute influenza Type B. The patient recovered (date not reported). Documents held by sender: None.					Y	0			Y	12/29/2006	12/29/2006	0	Diagnostic tests included a viral wash that was positive for influenza Type B, a negative (respiratory syncytial virus)test, a sedimentation rate (SED rate) of 28, a CBC (complete blood count) that had a left shift, a negative blood culture and sensitivity test, and a negative chest x-ray.	UNK	UNK			Not reported		200900950	1						2	Asthma; Blood culture negative; Body temperature increased; Bronchitis; Chest X-ray normal; Conjunctivitis; Cough; Ear pain; Full blood count abnormal; Influenza; Influenza serology positive; Irritability; Nausea; Pneumonia; Red blood cell sedimentation rate increased; Respiratory distress; Respiratory syncytial virus test negative; Rhonchi; Viral test positive; Vomiting; Wheezing; Asthma; Blood culture negative; Body temperature increased; Bronchitis; Chest X-ray normal; Conjunctivitis; Cough; Ear pain; Full blood count abnormal; Influenza; Influenza serology positive; Irritability; Nausea; Pneumonia; Red blood cell sedimentation rate increased; Respiratory distress; Respiratory syncytial virus test negative; Rhonchi; Vomiting; Wheezing	DTAP~SANOFI PASTEUR~U1857CA~3~IM~UN~DTAP (TRIPEDIA)~2|FLU3~SANOFI PASTEUR~U2191C~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB130AA~1~IM~UN~HEP A (HAVRIX)~2|PNC~PFIZER\WYETH~B08657C~3~IM~UN~PNEUMO (PREVNAR)~2|DTAP~SANOFI PASTEUR~U1857C~3~IM~UN~DTAP (TRIPEDIA)~3|FLU3~SANOFI PASTEUR~U2191CA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~3|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB130AA~1~IM~UN~HEP A (HAVRIX)~3|PNC~PFIZER\WYETH~B08657C~3~IM~UN~PNEUMO (PREVNAR)~3	USA	Hospitalisation	Influenza
0358758	10/06/2009	NY	55.0	55		F	10/06/2009	Facial swelling, flushing of face/neck, hives				Y					Y	09/24/2009	09/24/2009	0		PUB	UNK		none reported	codeine			1						2	Feeling hot; Flushing; Flushing; Swelling face; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA449BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA449BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Emergency room visit	Influenza
0358786	10/06/2009	NY	46.0	46		F	10/06/2009	Pruritis all over, dyspnea				Y					Y	09/24/2009	09/24/2009	0		PUB	UNK		none reported	none			1						2	Pruritus; Dyspnoea; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA449BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA449BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Emergency room visit	Influenza
0359501	10/06/2009	VA	42.0	42		F	10/02/2009	Couple of days after vaccine administered patient broke out in hives. Benadryl.									U	09/28/2009	09/30/2009	2		OTH	OTH						1						2	Erythema; Oedema peripheral; Pruritus generalised; Rash generalised; Skin burning sensation; Skin warm; Urticaria; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848P1C~1~ID~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848P1C~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA		Influenza
0359508	10/06/2009	IN	30.0	30		F	10/05/2009	I recieved the vaccination for pneumonia in my left arm and the seasonal flu shot in my right on 10/2/09. On 10/3/09 my Left arm started to hurt and got progressively worse, a red blotch appeared near the injection site and then more blotches presented below the site and continue to enlarge. There is currently a 4 inch x 1 inch band of red swelling below the injection site on my left arm. There is a palm-sized hardened painful red swollen lump at the injection site. It is VERY painful to touch or move and I cannot bear to sleep on it. It is hard to dress myself, or drive, reaching in an upward movement is nearly impossible for the pain. Seperate reaction:  Around 9 pm on 10-3-09 I was cleaning my kitchen floor and suddenly became very very cold and started to ache. I put on my coat and went to get my friend upstairs for help. He bundled me up in a blanket and set me in front of the fireplace in my recliner but I kept shivering with fever for hours even though it was 72 in the house. I finally went to bed in a great deal of pain from my arm, freezing cold with fever, and sore all over. I had continued fever/chills/ache and severe arm pain on 10-4-09. The fever was gone by 10-5-09 but my arm is still very swollen and exceptionally painful and I hope to get into the doctor 10/6/09 for help and relief.				Y					N	10/02/2009	10/03/2009	1	No tests run yet.	UNK	UNK	Neuva Ring, Zyrtec, Pepcid	No	Environmental allergies, athsma, oto-sclerosis, urticaria			1						1	Activities of daily living impaired; Chills; Feeling cold; Injected limb mobility decreased; Injection site erythema; Injection site induration; Injection site mass; Injection site pain; Injection site swelling; Pain; Pain in extremity; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~972165P~7+~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~UNKNOWN MANUFACTURER~1314Y~1~~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0359517	10/06/2009	MA	4.0	4		M		24 hours post vaccination, started with blotchy rash to back of neck and ankles, was given BENADRYL and woke in AM of 10/01/2009 with rash that was raised welts, whitish extending onto face and  head. Diagnosed as urticaria.				Y					Y	09/29/2009	09/30/2009	1		PVT	UNK			None			1						1	Rash macular; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500673P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0359540	10/06/2009	CA				F	09/29/2009	Received FLUMIST 9/16. Cough and fever 3 days later, came to our office saying swabbed. Asked pt if wet or dry. She said dry, showed Q-tip and she said that's what it looked like.													Strep screen negative	PVT	UNK						1						1	Cough; Pyrexia; Streptococcal identification test negative	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0359542	10/06/2009	NC	7.0	7		F	10/02/2009	Less than 24 hours after receiving vaccine, pt developed bilateral lower extremity paresthesias - reported no feeling in legs and complained of pain as well - neuro exam by MD was consistent with decreased sensation to just below both knees; by 4PM on 10/1/09 at f/u visit, neuro symptoms resolved; pt still had low grade fever. Pt also had fever of 102 for these 3 days.				Y					Y	09/28/2009	09/29/2009	1	none	PUB	UNK						1						1	Cervical dysplasia; Pain; Paraesthesia; Pyrexia	FLUX~SANOFI PASTEUR~U3179BA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0359548	10/06/2009	MI	46.0	46		F	10/06/2009	sudden onset sob, wheezing, chest burning, uncontrolled coughing, eyes burning turned very red used 50mg benadryl po to calm symptoms lasted about 30 minutes continued with coughing dry red eyes and hoarse voice for 3 hours after eyes still slightly red next morning									Y	10/05/2009	10/05/2009	0		PUB	UNK		NO	Latex allergy			1						1	Chest pain; Cough; Dysphonia; Dyspnoea; Eye irritation; Ocular hyperaemia; Wheezing	FLUX~SANOFI PASTEUR~U3199AA~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359551	10/06/2009	NC	37.0	37		F	10/05/2009	Redness, sore at injection site.										10/02/2009				PVT	UNK						1						1	Injection site erythema; Injection site pain	FLUX~SANOFI PASTEUR~UT3172BA~UNK~IJ~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359552	10/06/2009	MI	14.0	14		F	10/05/2009	Patient was in for a nurse visit, patient's mom was given form to fill out. After patient received vaccine patient felt lightheaded, hot and could not hear. Patient was brought back into exam room and R.N. looked over patient. Patient's mom stated she didn't read form before vaccine given. Spoke with Dr. and he examined patient, gave orange juice and patient released by Dr.									Y	10/05/2009	10/05/2009	0		OTH	PVT	SPRINTEC 0.25/0.035mg; DDAVP 0.2mg					1						1	Deafness; Dizziness; Feeling hot	FLU3~SANOFI PASTEUR~U3209AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359557	10/06/2009	MA	69.0	69		F	09/29/2009	At injection site have rash and welt that hurts.									U	09/27/2009	09/29/2009	2		OTH	PUB						1						1	Injection site pain; Injection site rash; Injection site urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359558	10/06/2009	MA	64.0	64		F	10/06/2009	Large red swollen area, warm to touch, approx 40mm circumference on L upper arm									Y	10/05/2009	10/06/2009	1	none	PUB	PVT		none	none			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~CSL LIMITED~8549111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359559	10/06/2009	TN	32.0	32		F	10/06/2009	Rash at injection site. Dizziness.				Y					Y	10/02/2009	10/02/2009	0		UNK	UNK	Lorazapam, Synthroid, Lamictal	Rash at injection site and slight vertigo.				1						1	Dizziness; Injection site rash	FLU3~SANOFI PASTEUR~u3214aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359561	10/06/2009	TN	3.0	3		F	10/06/2009	rash at injection site.									Y	09/14/2009	09/14/2009	0		UNK	UNK	None	no	None			1						1	Injection site rash	FLU3~SANOFI PASTEUR~u3191aa~UNK~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359563	10/06/2009	FL	32.0	32		F	10/06/2009	rash on rt hand to upper arm same arm vaccine given- benadryl taken									Y	10/01/2009	10/01/2009	0		PUB	UNK		rash on rt side arm from hand til upper arm				1						1	Injection site rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA284AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0359564	10/06/2009	KY	8.0	8		F	10/06/2009	Swollen red bumps on Left arm (site of Fluzone injection) from site to elbow.  No itching.									U	10/02/2009	10/02/2009	0	None	PVT	PVT		None	None			1						1	Injection site erythema; Injection site papule; Injection site swelling	FLU3~SANOFI PASTEUR~U3192AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359565	10/06/2009	MO	51.0	51		F	10/06/2009	At 4:30 pm (2 1/2 hr post inj) tickling in throat, cough, neck tight and back of tongue swelling. Benadryl shot - slept- left hospital at 9:30 pm.				Y					Y	10/05/2009	10/05/2009	0	None	PUB	PVT		None	Asthima - like reactions in past with other things allergy to Mickey beer.			1						1	Cough; Musculoskeletal stiffness; Swollen tongue; Throat irritation	FLU3~SANOFI PASTEUR~U3193AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359566	10/06/2009	PA	48.0	48		F	09/28/2009	Hives and dyspnea within 30' after administration of vaccine IM.				Y					Y	09/24/2009	09/24/2009	0		PUB	PUB		None	CT-Dye; Sulfa; Penicillin; ALEVE			1						1	Dyspnoea; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA281AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0359567	10/06/2009	OH	2.0	2	.9	F	09/04/2009	Patient presented to the office with mild URI symptoms. Her lungs were clear on exam and she was breathing normally. She received the flu vaccine and 90 minutes later her mother described her as acting delirious. At 10pm (5 1/2 hours after the flu vaccine), her parents noticed labored breathing. She was seen in the emergency room at 5:30am the following morning and per report had diffuse expiratory wheezes and tachypnea with O2 saturation in the mid 80's. She was given one Albuterol neb, followed by 2 back-to-back Albuterol and ATROVENT nebs. She was also given ORAPRED 13mg po, however she remained in respiratory distress with O2 saturation in the mid 80's so she was given methylprednisolone 15mg IV bolus, magnesium sulfate 600mg IV, and placed on continuous Albuterol via nebulizer. She was then transported via ambulance to Hospital and admitted to the ICU at approximately 8:30 am on 8/27/2009. Her chest x-ray showed right upper lobe atelectasis and she was started on Vancomycin, Azithromycin, and Ceftriaxone IV to cover for a possible pneumonia. The following day her respiratory status continued to improve and her chest x-ray showed resolution of the right upper lobe atelectasis so her antibiotics were discontinued and she was transferred out of the PICU to the medical floor. She was discharged from the hospital on 8/29/2009 on oral steroids and Albuterol every 4 hours. 11/20/09:  ED Records and Discharge summary received for dates of service:  8/27/09 to 8/29/09.  Dx: Status asthmaticus.  Assessment:  Presented with increased WOB x 1 day.  O2 sats in mid 80's.  Tachnypneic with diffuse expiratory wheezes.  Admitted to PICU and treated with continuous Albuterol initially, then spaced out to Q 2 hrs.  Started on steroid therapy and antibiotic therapy.  Antibiotics d/c'd since unlikely to be infectious.  IV Fluids administered.  Weaned to Albuterol tx. Q4h without need for O2.  Albuterol MDI and controller medications started.  To follow up with PMD and pediatric allergist.			Y	Y	Y	2			Y	08/26/2009	08/26/2009	0	Influenza A/B PCR neg; Parainfluenza 1,2,3, PCR neg; Human Metapneumovirus PCR neg; RSV PCR neg.  11/20/09:  ED Records and Discharge summary received for dates of service:  8/27/09 to 8/29/09. Labs and Diagnostics:  CBC x 2 WNL.	PVT	PVT		URI with serous middle ear effusion	UTI (age 5 mos, normal Renal US/VCUG).  11/20/09:  ED Records and Discharge summary received for dates of service:  8/27/09 to 8/29/09.PMH:  Chronic congestion and recurrent otitis media, allergic to PCN			1						1	Atelectasis; Chest X-ray abnormal; Delirium; Dyspnoea; Influenza serology negative; Intensive care; Oxygen saturation decreased; Polymerase chain reaction; Respiratory distress; Respiratory syncytial virus test negative; Tachypnoea; Virus serology test negative; Wheezing	FLU3~SANOFI PASTEUR~UT3171DA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening,Hospitalisation	Influenza
0359570	10/06/2009	CA	75.0	75		M	10/06/2009	Patient described that the site of injection was vary stiff for 3-4 days. The site of injection was in a lot of pain for 2 days. There are 2 bruises with purple and yellowish color near site of injection, but patient denied taking any blood thinner (Aspirin, COUMADIN, etc).									Y	09/27/2009	09/27/2009	0	None	OTH	OTH	Lovastatin; Nortriptyline	None				1						1	Injection site haematoma; Injection site pain; Musculoskeletal stiffness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359572	10/06/2009	TX	5.0	5		M	10/03/2009	Pt had a fever topping at 101.4 for 2 days after flu shot. The 3rd day after flu shot topped at 100.4. 4th day after Flu shot temp. up to 101.5. Visited Dr's office. He had the flu. Dr. insisted flu was not obtained by flu shot.				Y					Y	09/25/2009	09/26/2009	1	Dr. Tested for strep & flu. Found pt had flu. Dr insisted pt did not get the flu from the flu shot.	PVT	PVT	None	No symptoms. None to my knowledge.	Seasonal allergies.			1						1	Influenza serology positive; Pyrexia; Streptococcal identification test	FLUX~UNKNOWN MANUFACTURER~~1~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0359573	10/06/2009	AK	47.0	47		F	09/29/2009	Local swelling 6-8 inches in diameter - no redness, some bruising, painful - no other prominent signs, no itching.									U	09/28/2009	09/28/2009	0	Pt had insulin injection (abdominal ) w/bruise	OTH	PUB	Benzapril; EFFEXOR; PAXIL; DEPAKOTE; Methor; Glime; LANTUS; Estradiol; JANUVIA; Cholesterol	None	Eryth; Latex; Aspirin; Ibuprofen	Similar - 1991~Influenza (Seasonal) (no brand name)~1~0.00~Patient		1						1	Contusion; Local swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98433P1~2~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359574	10/06/2009	MN	53.0	53		M	10/02/2009	3 + inch in diameter swelling and redness in left deltoid.  Onset 24 hours after injection.  Numbness, cramping of left hand that lasted 3-4 days.  Site is still sensitive today.									Y	09/25/2009	09/26/2009	1	0 - A call was made to ER, advise via phone.	PVT	OTH	FOSAMAX; FLOVENT; NASACORT; SINGULAIR; SEREVAR; ALBUTEROL; MEDROL - MV.	No	Osteopenia; Asthma.			1						1	Hypoaesthesia; Injection site erythema; Injection site swelling; Muscle spasms	FLU3~SANOFI PASTEUR~U3191AA~2~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1089X~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359575	10/06/2009	MD	13.0	13		F	10/01/2009	Some redness and swelling at site, right deltoid, right side neck, torso sweating, cold/clammy, color pale on right side. Immunization administered 9/29/09. Evaluated in office 9/30.										09/29/2009	09/30/2009	1		PVT	UNK		None	None			1						1	Cold sweat; Hyperhidrosis; Injection site erythema; Injection site swelling; Pallor	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~MERCK & CO. INC.~06054~1~IM~LA~HEP A (VAQTA)~1|MNQ~SANOFI PASTEUR~U3058AA~1~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0359576	10/06/2009	IL	16.0	16		M	09/30/2009	Pt fainted after leaving pharmacy, in the parking lot, but got up before paramedics arrived. He was checked out in the ambulance. Paramedics said fainting was due to drop in blood pressure. Spoke to the father afterwards and was told the patient is fine.									Y	09/29/2009	09/29/2009	0		OTH	PVT						1						1	Blood pressure decreased; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359577	10/06/2009	MI	56.0	56		F	10/01/2009	Developed hives around injection site, spreading across chest to other arm. Dyspnea. Tachycardia-pulse 135. Sweating. Received flu shot last year without incident.				Y					Y	09/19/2009	09/19/2009	0	Allergic reaction to FLUVIRIN per ER doctor.	PVT	UNK		None	No			1						1	Dyspnoea; Hyperhidrosis; Injection site urticaria; No reaction on previous exposure to drug; Tachycardia; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97845P2~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359579	10/06/2009	NC	54.0	54		F	09/28/2009	Employee noticed redness and swelling of upper left arm the day following her AFLURIA vaccine. Also states the vaccine was given below the deltoid are in mid upper left arm. 9/28/2009 10:15 9-10 cm oval reddened area mid upper left arm.				Y					Y	09/25/2009	09/26/2009	1		PVT	PVT	EFFEXOR; AMBIEN; XANAX		Mild COPD	Red and swollen arm~Pneumo (no brand name)~~0.00~Patient		1						1	Injection site erythema; Injection site swelling	FLU3~CSL LIMITED~06549111A~UNK~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0359582	10/06/2009	NC	62.0	62		F	10/06/2009	Flu like symptoms:  Fever, SOB.  Was admitted to the hospital on 9/25/09 and was diagnosed with H1N1 and deteriorated; was placed on a ventilator and expired on 10/5/09 at approxitmately 1800 hours. 10/9/09 Prelim autopsy report received with the following findings:  Multilobar pneumonia (all lobes severely involved). Post mortem bacterial, fungal, acid fast and viral cultures pending.  H1N1 (-). Renal failure probably 2' to acute tubular necrosis.  10/21/2009 hospital records for date 10/1- 10/5/ 2009, patient with 1 week hx of fever, malaise.  nausea, vomiting, and chest discomfort. Saw PCP 9/26/2009 and thought to be viral, sx progressed, cough worsened and patient became dyspneic. To hospital 10/1/2009 in respiratory failure. TX: placed on continuous ventilation with nitrous oxide and pressors, IV ABX Zyvox, Clindamycin, Levaquin, Aztreonam, Cleocin, Xigris, Serum Bicarbonate. DC DX's:  Severe Multilobar Pneumonia, Respiratory failure, Renal failure, Metabolic Acidosis.  12/29/09 Autopsy report received. DOD 10/5/2009. Cause of Death: Multilobar pneumonia secondary to Legionella, non-pneumophilia species.  Additional information abstracted: Patient developed community-acquired bilateral pneumonia causing severe hypoxia and multiorgan system failure.	Y	10/05/2009			Y	5			N	09/23/2009	09/25/2009	2	Labs and Diagnostics: H1N1 (-). Labs:  Admission: CBC norm, CMP: Na 127, K-3.2, Albumin-1.9 all Low, Creatinine 2.4, BUN-36, AST-158, ALT-81 all HIgh Viral respiratory panel neg, MRSA screening negative, Urine strep pneumonia antigen negative, Mycoplasma IgM AB negative, Urine Legionella antigen negative, Blood and Urine cultures negative Dx studies/Xrays: CXR  multilobar pneumonia , Echocardiogram pericardial effusion	UNK	UNK		None	Psoriasis PMH: psoriasis Allergies: PCN			1						1	Death; Dyspnoea; Influenza like illness; Mechanical ventilation; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848PIC~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0359583	10/06/2009	MI	55.0	55		F	10/06/2009	Pt developed redness and warmth on arm  where vaccines were given,below the deltoid.  Went to urgent care center after calling Dr on call, and was diagnosed with cellulitis and started on oral antibiotic.				Y					Y	09/29/2009	10/03/2009	4		UNK	UNK						1						1	Cellulitis; Injection site erythema; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA454CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0504Y~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0359586	10/06/2009	TX	54.0	54		M	10/06/2009	double and blurred vision, headache12/01/09 Medical records received for DOS 10/08/09 DX: Acquired Vertical Diplopia C/O visual disturbance X 4 days, diplopia, headaches, swollen lids  12/7/09 Employee health records received.   DX: Acquired vertical diplopia				Y					U	10/01/2009	10/02/2009	1	MRI to be done  Diagnosed with Optic Neuritis.  LABS: MRI brain/orbits done 10/6/09 WNL w/paranasal sinus mucosal disease. Creatinine 1.3(N).	MIL	PVT		none	12/01/09 PMH: NKDA, arthritis.			1						1	Diplopia; Headache; Nuclear magnetic resonance imaging abnormal; Vision blurred	FLU3~GLAXOSMITHKLINE BIOLOGICALS~A458BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0359587	10/06/2009	MI	34.0	34		F	10/06/2009	Pt had grand mal seizure per EMS, found post ictal having had a witnessed 2 minute seizure after a period of feeling ill and left arm weakness.				Y					Y	09/25/2009	10/01/2009	6	CT, labs, EKG, Kepra initiated in ER.  Follow up with neurology for EEG and MRI not completed yet.	PVT	UNK	Minocycline only.	cold, recovering	none			1						1	Computerised tomogram; Electrocardiogram; Electroencephalogram; Feeling abnormal; Grand mal convulsion; Malaise; Muscular weakness; Nuclear magnetic resonance imaging; Postictal state	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA278AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0359588	10/06/2009	PA	35.0	35		F	10/06/2009	High fever, sore throat, chest congestion, cough, sinus congestion, worst headache ever, vomiting, like I got the flu. My husband got his shot at the same time and had the same symptoms. Today, we are both still sick.									Y	09/25/2009	09/26/2009	1		PUB	PVT	Tegretol, Zoloft	No	Epilepsy, s/p hysterectiomy and appendectomy			1						1	Cough; Headache; Influenza like illness; Oropharyngeal pain; Pyrexia; Sick relative; Sinus congestion; Upper respiratory tract congestion; Vomiting	FLUX~SANOFI PASTEUR~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359589	10/06/2009	WI	48.0	48		M	10/06/2009	Throat tightening and feeling very sore when swallowing.  Wheezing and coughing up mucous, which seemed to be forming in my throat quickly.  Very red eyes, with mucous coming out of tear ducts.  Fever developed about an hour later, peaking at 102.5 (measured at ER) and disappearing within a couple of hours.  Vomiting about two hours into reaction.				Y					Y	10/05/2009	10/05/2009	0	The ER took lots of blood & urine test, but I don't have the data.  Chest xrays showed no worrisome build up in the lungs.	UNK	UNK		No	Cat, dust allergies.  High blood pressure (treated) and cholesterol (treated).	Nearly identical to this event. But I've several flu shots in between.~Influenza (Seasonal) (no brand name)~~38.25~Patient		1						1	Blood test; Chest X-ray normal; Eye discharge; Ocular hyperaemia; Oropharyngeal pain; Productive cough; Pyrexia; Throat tightness; Urine analysis; Vomiting; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0359590	10/06/2009	AZ	24.0	24		F	10/06/2009	Arm experienced sever swelling over approximately 18 sq. inches. Hot and tender to touch. Difficulty breathing, with tightness of the chest experienced for 48 hours after symptom onset. Physician prescribed course of prednisone (20mg 2x a day) as well as icing of the affected area, 600 mg of ibuprofen every 6 hours, rest and fluids.				Y					Y	09/28/2009	09/29/2009	1	Physician's external exam.	PUB	PVT		None	None			1						1	Chest discomfort; Dyspnoea; Oedema peripheral; Skin warm; Tenderness	FLUX~UNKNOWN MANUFACTURER~~7+~IJ~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~~LA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0359592	10/06/2009	IN	58.0	58		F	10/06/2009	Thrombocytopenia (plt=6k).  Epistaxis, petechial rash, bruising, mouth sores on tongue 10/19/09 Medical records received from hospital date 10/1/09 and Labs from 10/01/09 to 10/9/09. DX: Thrombocytopenia. Presenting SX: pt states received flu vaccine 9/24 c/o arm soreness same day. 9/25 c/o left side neck pain. On 9/26 c/o right side neck pain. 9/30 pt developed epistaxis. 10/1 presented with epistaxis, sores on tongue, buccal mucosa, petechial rash, increase bruising on legs. Assessment: increase BP, buccal and tongue bleeds, petechial rash over body greater on legs with ecchymosis. Pt admitted to hospital.			Y		Y	8			U	09/24/2009	09/30/2009	6	Plts=5k (10/6), 4k (10/2) 10/19/09 Medical records received from hospital date 10/1/09 and Labs from 10/01/09 to 10/9/09. Diagnostics/Labs: WBC 24.68(H), RBC 2.8(L), HGB 8.0(L), HCT 24.5(L), RDW-CV 16.3(H), platelets 8(L), GFR 113(ABN), BUN 24(H), CO2 21(L).	UNK	UNK	None	None	None 10/19/09 Medical records received from hospital date 10/1/09 and Labs from 10/01/09 to 10/9/09. PMH:  tonsillectomy/adenoidectomy, D&C x2, Surgery Rt. Foot, Rt. Rotator cuff			1						1	Contusion; Epistaxis; Petechiae; Platelet count decreased; Stomatitis; Thrombocytopenia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA454BA~UNK~IM~~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Life Threatening,Hospitalisation	Influenza
0359593	10/06/2009	CA	2.0	2	.7	M	10/06/2009	Flu Mist vaccine on 10/03/2009 woke Monday 10/5/2009 with uticaria rash on waist and trunk									U	10/03/2009	10/05/2009	2	None	PVT	PVT	None	cough no fever	NONE KNOWN			1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500685P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0359594	10/06/2009	MT	67.0	67		M	10/06/2009	next morning had large welts, hives on back, extremely itchy.  on R side of back & shoulder about size of quarter to half dollar.  Lasted at least one week.  Had bleeding from scratching, but no infection.  Resolved in one week									Y	09/16/2009	09/17/2009	1	none	PUB	PUB	Protonix for stomach, Avodart for prostate, Nadonal for hypertension	None	hypertension, enlarged prostate, stomach upsets			1						1	Excoriation; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U3194AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359599	10/06/2009	OR	60.0	60		F	10/06/2009	rattling in lungs, hoarseness, could hardly talk, coughed up pinkish colored stuff, severe difficulty breathing				Y					Y	10/02/2009	10/04/2009	2	breathing treatment at emergency room, my blood pressure was 208/111, chest xray, ekg, lab work and angiogram.	UNK	UNK	I have had no other vaccines recently, I get the seasonal flu shot each year and have never had a reaction.  I take several medications.	No	asthma and diabetes			1						1	Angiogram; Blood pressure increased; Breath sounds abnormal; Chest X-ray; Dysphonia; Dyspnoea; Electrocardiogram; Laboratory test; Productive cough; Sputum discoloured	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359600	10/06/2009	NH	50.0	50		M	09/28/2009	Employee states high fever and body aches approximately 10 hours after vaccine. Symptoms lasted approximately 1 day.									Y	09/15/2009	09/15/2009	0		OTH	PVT		None	None			1						1	Pain; Pyrexia	FLU3~SANOFI PASTEUR~M31877AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359601	10/06/2009	NY	39.0	39		F	09/29/2009	Started itching at site-red, hot itchy- (ominates later, chest felt tight-used Albuterol inhaler (minimal relief)-took Benadryl 25mg-225pm. Still itchy all over, ears hot. Voice Hoarse. Benadryl 25 mg IM 3pm. BP-132/78 p-120. Also has				Y					Y	09/29/2009	09/29/2009	0		PVT	PVT	Adderall, Albuterol Inhaler PM, Optivar Solution, HCTZ, Yaz, MUI, Benicar, Fluontin	None				1						1	Chest discomfort; Dysphonia; Injection site erythema; Injection site pruritus; Injection site warmth; Pruritus; Skin warm	FLU3~SANOFI PASTEUR~U3259EA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359602	10/06/2009	MN	75.0	75		M	10/16/2009	he had a hard time navigating to the bathroom on 2 separate occasions and is unable to walk on his own.  10/19/09 Physician fax received for date of service 10/12/09.  Dx:  Death secondary to Guillain-Barre Syndrome. Assessment:  Intubated due to GBS.  EMG showed denervation distally.  Due to increased neuronal injury and poor prognosis (also coupled with post-Polio syndrome) the family decided to extubate the patient.  12/1/09 ED and Hospital records received. Service dates 9/28/09 to 10/12/09. Assessment: Severe Guillian-Barre Syndrome. Patient developed profound, progressive and generalized weakness over the last 24-36 hours. Numbness toes, feet, fingers. Unable to walk on his own. Peripheral edema. Rhonchi bilateral. Intubated. Subdural hematoma. Hematuria with clots. Gallbladder polyp, Renal cyst. Atrial fibrillation. Sinus Bradycardia. Left ventricular hypertrophy. Nonresponsive to voice / touch. DTR's absent. IVIG Administered.	Y	10/12/2009			Y	14				09/24/2009	09/27/2009	3	LP done. 10/19/09 Physician fax received for date of service 10/12/09. Labs and Diagnostics:  EMG:  Denervation distally. 12/1/09 ED and Hospital records received. Service dates 9/28/09 to 10/12/09. LABS and DIAGNOSTICS: Chest X-ray - Abnormal. EMG - Abnormal. MRI Brain Abnormal. Abdominal US - Abnormal. ECG - Abnormal. CBC - WBC 11.4 (H) RBC 3.47 (L) HGB 11.1 (L) HCT 32.2 (L). CHEM - Glucose 123 (H) Calcium 8.1 (L) ALKPHOSPH 236 (H) AST 171 (H) ALT 287 (H).	UNK	UNK		kidney stone issues	hx polio, prostate ca, hyperlipediemia, smokes, emphesema, diverticulitis, hemmroids, ventral hernia, osteoarthritis, skin ca, no allergies. 10/19/09 Physician fax received for date of service 10/12/09.PMH:  Post-Polio syndrome. 12/1/09 ED and Hospital records received. Service dates 9/28/09 to 10/12/09. PMH: Polio with kyphoscoliosis, atrophy (L) lower extremity and arm. Nephrolithiasis. Carcinoma of prostate. Hyperlipidemia. Diverticulosis / Diverticulitis. Hemorrhoids, tosillectomy, ventral hernia, basal cell carcinoma of skin, osteoarthritis.			1						1	Abasia; Lumbar puncture; Blood product transfusion; Computerised tomogram head; Electromyogram; Guillain-Barre syndrome; Helicobacter pylori identification test negative; Hepatitis viral test; Neurological examination; Viral test negative	FLUX~SANOFI PASTEUR~U3192AA~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U3192AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Results in Death	Influenza
0359603	10/06/2009	AZ	65.0	65		F		Had flu shot, throat started to tickle, started coughing-felt throat thickening, had shortness of breath, difficulty breathing, called 911 and gave EPI. Transported to hospital. Husband present- Observed her for several hours gave a breathing treatment and sent her home.									Y	09/30/2009	09/30/2009	0	none	PUB	UNK	none	no meds -	none; penicillin; Sulfa and Iodine contrast			1						1	Cough; Dyspnoea; Pharyngeal oedema; Throat irritation	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98433P1~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359604	10/06/2009	NY	60.0	60		F	09/30/2009	1 1/2 hours after injection-violent evacuation of bowels. Pain at site almost immediate. Bone pain to all extremities starting in legs then arms. Weakness and fatigue followed by chills-remained in bed for 20 hours. Site and extremity pain continues but improving somewhat.									U	09/29/2009	09/29/2009	0		PUB	OTH		None	Allergy PCN;HTN			1						1	Asthenia; Bone pain; Chills; Diarrhoea; Fatigue; Hypersomnia; Injection site pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA281AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0359608	10/06/2009	VA	43.0	43		F	10/06/2009	Flu vaccine administered at 10:00 AM.  Headache at 10:05 AM.  Vertigo at 11:15 AM.				Y					U	10/06/2009	10/06/2009	0	Orthostatic vital signs	MIL	UNK	None	None	Anemia, Hyperlipidemia, and Positional Vertigo			1						1	Headache; Vertigo	FLU3~SANOFI PASTEUR~UT3172AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359609	10/06/2009	CA	38.0	38		F	10/06/2009	Increased anxiety with facial swelling.  Redness and swelling at injection site.  Ears bright red.  Left arm hot to the touch, with warmth and redness.  Sensation of waves of warmth moving across upper body and thighs.				Y					Y	10/02/2009	10/02/2009	0	None	PUB	PVT		None	None	localized swelling at site of injection~Influenza (Seasonal) (AFLURIA)~UN~37.00~Patient		1						1	Anxiety; Feeling hot; Injection site erythema; Injection site swelling; Injection site warmth; Swelling face	FLU3~CSL LIMITED~09249111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0359610	10/06/2009	NY	59.0	59		M	10/06/2009	Flush, sweaty, fast heart beat, extreme nausea and abdominal discomfort, light headed and weak feeling. This lasted for an hour, went back to bed, and woke up at 6 AM feeling a little weak in the legs. As the day progress, I felted better.									Y	10/05/2009	10/06/2009	1		PUB	PVT		No	Diabetes			1						1	Abdominal discomfort; Asthenia; Dizziness; Flushing; Heart rate increased; Hyperhidrosis; Muscular weakness; Nausea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960355P~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359611	10/06/2009	WI	58.0	58		F	10/06/2009	Severe Congestion, Sore Throat, slight nausea lasted for 2 days, then rewsolved. Patient came down with hives on 10/04/2009 in the AM. Taking benadryl									Y	09/28/2009	09/28/2009	0		UNK	UNK	unknown, none in our records	no	none			1						1	Nausea; Oropharyngeal pain; Upper respiratory tract congestion; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA282AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0359612	10/06/2009	NY	49.0	49		F	10/06/2009	Reported severe itching to palms and soles of feet and reports palpitations.				Y					Y	09/29/2009	09/30/2009	1		PUB	UNK	None	None reported	Allergies to dust, mold, pollen			1						1	Palpitations; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA449BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0359614	10/06/2009	NY	45.0	45		F	10/06/2009	Swelling at site, with erythema and increased warmth and pain, along with vesicles in area of vaccine site. Seen by dermatologist also, not zoster.				Y					Y	09/29/2009	09/29/2009	0		PUB	UNK	ASA 81 mg daily	None reported	Reported allergy to sulfa meds			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site vesicles; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA449BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0359615	10/06/2009	AZ	47.0	47		F	10/06/2009	Itching on neck, rash on both sides of neck, welt over collarbone area on skin.									Y	10/01/2009	10/01/2009	0	Took about 2 days to go away, put Lanacaine cream on area	PUB	UNK	Sanofi Pasteur vaccine was ADACEL. On no other medications	NONE	PCN/Ampicillin allergies	rash~DTaP (Tripedia)~~9.33~Patient		1						1	Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U3259FA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359616	10/06/2009	MA	70.0	70		M	10/06/2009	injection site swelling up a little, pt had vaccine before though, asked pt to stay back for 10 minutes to make sure pt is ok. Pt was fine the whole time. Swelling when down after 5 min. Pt left store with advices on what to do with allergic rxn									Y	10/05/2009	10/05/2009	0		PUB	PVT		no	no			1						1	Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98445p1~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359632	10/06/2009	AZ	19.0	19		F	10/06/2009	Redness/itching generalized. Took Benadryl 25 mg orally. Redness/itching went away. Still has bumps on top half of body.									Y	09/28/2009	09/29/2009	1	N/A	PUB	UNK	No other adverse reactions in the past. Taking no other medications.	NO	Hx of general allergies			1						1	Erythema; Pruritus generalised	FLU3~SANOFI PASTEUR~U3174EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359633	10/06/2009	VI	3.0	3		M	10/06/2009	mother called 10/2/09 stating that child not moving his leg, dragging it behind him when he walks. denies swelling. limping. mother had given advil once for pain the first day only. Advised Advil for pain and to f/u with child's pediatrician. phone call several hours later to mother who stated that child was moving leg more after advil.  follow up phone call 10/5 in which mother told me she administered advil over the weekend and child was back to normal and riding his bike and playing yesterday.									Y	09/29/2009	10/01/2009	2	none	PUB	PUB	none	none	none			1						1	Injected limb mobility decreased; Pain	DTAP~SANOFI PASTEUR~UF599AA~4~IM~LA~DTAP (TRIPEDIA)~1|FLU3~SANOFI PASTEUR~U3177BA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~U2472AA~4~IM~RA~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~D21051~4~IM~LL~PNEUMO (PREVNAR)~1|VARCEL~MERCK & CO. INC.~0690Y~1~SC~LA~VARICELLA (VARIVAX)~1	USA		Influenza
0359634	10/06/2009	NC	7.0	7		M	10/06/2009	Collapsed,pale ,sweating hypotension,bradycardia,feable pulse Epipen jr 0.15mg given,benedryl 2tsp given EMS called assessed, father didnt want to go to ER.Patient was observed in the office for 90 mins.His condition came back to normal and sent home									Y	10/06/2009	10/06/2009	0	none	PVT	PUB		NO	NO			1						1	Bradycardia; Hyperhidrosis; Hypotension; Pulse pressure decreased; Syncope	FLU3~SANOFI PASTEUR~U3177DA~2~~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB342EB~1~~LA~HEP A (HAVRIX)~1	USA		Influenza
0359635	10/06/2009	NM	50.0	50		F	10/06/2009	Headache,Lymphadenopathy,Fatigue,Muscle Aches lasting 2 weeks duration									Y	09/15/2009	09/16/2009	1		UNK	PVT	IBUPROFEN	none	none			1						1	Fatigue; Headache; Lymphadenopathy; Myalgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA456BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0359636	10/06/2009	MN	50.0	50		F	10/06/2009	See last screen for symptoms									Y	10/02/2009	10/03/2009	1	None	PVT	PVT		Twelve hours after injection patient reported symptoms of:fever,uncontrollable shaking,all over body pain,weakness and disorientation. Today she reports feeling achy,weak,swollen lymph nodes in my armpit and neck on the side the injections were given.	Migraine,depresson,genital herpes,Lupus,mitral valve disorder			1						1	Asthenia; Disorientation; Lymph node pain; Lymphadenopathy; Pain; Pyrexia; Tremor	FLU3~SANOFI PASTEUR~U3200AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1296X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359637	10/06/2009	FL	67.0	67		F	10/06/2009	Hoarseness, difficulty breathing, paleness, weakness, a fast heart beat, and dizziness.				Y					Y	09/09/2009			chest x-ray	UNK	UNK		Perhaps a cold.	yes			1						1	Asthenia; Chest X-ray; Dizziness; Dysphonia; Dyspnoea; Heart rate increased; Pallor	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0359638	10/06/2009	NY	43.0	43		F	10/06/2009	severe headache, rash, severe pruritis, laryngitis/sore throat				Y					U	10/02/2009	10/02/2009	0	Employee not recovered yet.	PUB	UNK		None reported	none			1						1	Headache; Laryngitis; Oropharyngeal pain; Pruritus; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~96033 4P~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359640	10/06/2009	NY	59.0	59		M	10/06/2009	severe shaking chills with A. Fib (pt. has history of A fib)									Y	10/01/2009	10/02/2009	1		PUB	UNK	Fleconide, Sotalol, Warfarin, Diovan, Zemplar	none reported	PCN allergy			1						1	Atrial fibrillation; Chills; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~96033 4P~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359641	10/06/2009	IL	56.0	56		F	10/06/2009	Administration of vaccine was painful in left deltoid.  Arm remained sore that night after administration.  Pain in left shoulder has gotten prgressively worse each day since administration of vaccine to the point is very painful and has limited movement of left shoulder. No reddness, swelling or hot to touch at injection site.									N	09/22/2009	09/23/2009	1	None	PUB	PVT	prempro,atenolol,clonacepam,amitriptyline	No	No			1						1	Hypokinesia; Injection site pain	FLU3~SANOFI PASTEUR~U3173DA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359642	10/06/2009	UT	21.0	21		M	10/06/2009	First swelling above upper lip, within a couple hours mild swelling around mouth, cheeks, and eyes. Throat feels tight but still able to breathe and eat just fine.										10/05/2009	10/05/2009	0		PUB	PUB		None	None			1						1	Eye swelling; Lip swelling; Oedema mouth; Swelling face; Throat tightness	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359646	10/06/2009	CO	30.0	30		F	10/06/2009	Immediately following vaccine, client reports arm was sore, red, and warm to touch. This was the same reaction client had to first flu vaccine one year previously. Symptoms did not go away after one day, and arm felt hotter, so client went to clinic on 30 Sep. Site was then red, hot, swollen, firm, raised, and about the size of her palm. Client was given 7-day course of antibiotics to take 4 times daily. No relief of symptoms by 1 Oct. Client also reporting pain in elbow and wrist joints on 1 Oct. Advised client to try NSAIDs for pain relief and Benadryl for allergy symptom relief.				Y					U	09/29/2009	09/29/2009	0		UNK	UNK		no	n/a			1						1	Arthralgia; Immediate post-injection reaction; Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Vaccine positive rechallenge	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLU468CA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0359647	10/06/2009	IL	62.0	62		F	10/06/2009	headache, cold, hot, stomach queasy, overall soreness, tearing eyes, arm hurt									Y	10/01/2009	10/02/2009	1	none	UNK	PVT	zyrtec, fluticasone propionate   2 days earlier had cortisone injection in rt hand for granular anulare	No	respiratory allergies			1						1	Feeling of body temperature change; Headache; Induration; Lacrimation increased; Nausea; Pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359648	10/06/2009	ND	36.0	36		F	10/06/2009	bodyaches (hips mostly), headache for first 18 hours then developed a fever >103.5 for the next 48 hours. Also developed moderate diarrhea on 09/26/2009 which continued through 09/28/2009.  Treated with tylenol and ibuprofen, fever did not go lower than 100.5 until the evening of 09/27/2009.									Y	09/21/2009	09/24/2009	3	Influenza rapid screen was negative	PUB	UNK	Buproprion	None	None			1						1	Arthralgia; Diarrhoea; Headache; Influenza serology negative; Pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~3~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0359649	10/06/2009	VA	47.0	47		M	10/06/2009	patient says he has had continued pain in his arm at the site of the injection since the day he received it and has trouble lifting it above his head without pain. He states it is worse at night and has not changed much over the last month. I advised him that this was not a typical reaction and that if the pain continues or worsens to contact his physician for evaluation. He stated that if the pain is still present he will see a dr in 2 weeks.									U	09/06/2009	09/06/2009	0	none yet.	UNK	PVT	none reported to this pharmacy	no	no			1						1	Injected limb mobility decreased; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~96030 5P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359650	10/06/2009	GA	54.0	54		F	10/06/2009	severe hives, called on Dr, throat was feeling tight ,went to emergency room was given oral cortisone				Y					Y	10/04/2009	10/04/2009	0		UNK	UNK	valtrex - numbness,hives	no	none			1						1	Throat tightness; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960342P~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359651	10/06/2009	FL	67.0	67		F	10/06/2009	Red eyes, goopy, feverish/ chills/ sweats, achiness in legs, fatigue, N&V and diarrhea										10/06/2009	10/06/2009	0	Flu test A/B negative	UNK	PUB	Atenolol, Crestor	None	HTN, Hyperlipidemia			1						1	Chills; Diarrhoea; Fatigue; Hyperhidrosis; Influenza serology negative; Nausea; Ocular hyperaemia; Pain in extremity; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~u3213aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359652	10/06/2009	CA	89.0	89		M	10/06/2009	Developed hemorrhagic lesions left side of posterior neck. No pain or tingling.										09/29/2009	09/30/2009	1	photographs of lesions available	UNK	UNK		none	Epistaxis and septal erosions Allergic rhinitis			1						1	Skin haemorrhage	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|VARZOS~UNKNOWN MANUFACTURER~~UNK~~~ZOSTER (NO BRAND NAME)~1	USA		Influenza
0359654	10/06/2009	VT	15.0	15		F	10/06/2009	given nasal flu vaccine - had nose pain, felling of needing to sneeze, later medial face discomfort left greater than right, no runny nose, no cough, some headache bilat temples and some throat clearing.  Exam 10/6 reveals erythema and edema of nasal mucosa left > right.  treated with nasal steroid spray				Y						09/30/2009	09/30/2009	0		PVT	PUB		no	no			1						1	Discomfort; Erythema; Facial pain; Headache; Oedema; Rhinalgia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0359655	10/06/2009	AZ	64.0	64		M	10/05/2009	Muscle weakness, partial paralysis. Fatigue, high blood pressure, Guillain-Barre syndrome. 10/21/09 Hospital and ED records received DOS 9/17/09 to 9/19/09. Assessment: Malignant hypertension. Diabetes mellitus, new onset. Patient presented with generalized weakness, more to his left side. BP 236/145 Heart rate 90. 11/12/09 Medical records received for date 9/19/09 DX: HTN. Assessment: no c/o SOB. pt. d/c home 12/22/09 Duplicate ED/ Hospital records received for DOS 9/17/09-09/19/09.  12/22/09  PCP Medical records received for DOS 11/20/09. Pt. presents with h/o continued fatigue but improved strength; is able to walk, but needs to stop and rest frequently. Assessment:  recovering from Guillain-Barre syndrome; hypertension    12/22/09 Neurology consult records for DOS 10/01/09.  Pt. gives h/o inability to walk up flight of stairs due to fatigue one day after getting flu shot. Drove himself to ED and was hospitalized for hypertension management .  Did not have neurology consult or nerve conduction studies in hospital. Symptoms of weakness gradually improving.  Assessment: polyneuropathy				Y	Y	3		Y	U	09/16/2009	09/17/2009	1	10/21/09 Hospital and ED records received DOS 9/17/09 to 9/19/09. LABS and DIAGNOSTICS: EKG - Abnormal. CHEM - Potassium 3.3 mmol/L (L) Glucose 178 mg/dL (H). CBC - HGB 17.1 g/dL (H). Echocardiogram - Abnormal. Chest X-ray - Abnormal for interstitial prominence in the bases. 12/22/09 Diagnostics: Carotid Duplex scan: negative; CT Brain: normal	PUB	UNK	None	None	Osteomyelitis. 10/21/09 Hospital and ED records received DOS 9/17/09 to 9/19/09. Hypertension.			1						1	Fatigue; Guillain-Barre syndrome; Hypertension; Muscular weakness; Paralysis; Blood pressure increased; Chest X-ray normal; Computerised tomogram head; Echocardiogram; Face and mouth X-ray normal; Gait disturbance; Guillain-Barre syndrome; Muscular weakness; Scan brain; Ultrasound Doppler; Ultrasound Doppler normal	FLU3~SANOFI PASTEUR~U3211AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U3211AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation,Disabling	Influenza
0359656	10/06/2009	CA	71.0	71		M	10/06/2009	The patient experienced numbness on his face the day after the vaccine was administered which progressed to loss of functions of his right eyebrow. Pt was seen in ER 2 days after vaccine administered.				Y					N	09/30/2009	10/01/2009	1		PUB	PUB						1						1	Hypoaesthesia facial; Mobility decreased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359657	10/06/2009	ME	63.0	63		M	10/06/2009	Fever 30 minutes after vaccine administration.									U	10/06/2009	10/06/2009	0		PVT	UNK		None	Mechanical heart valve			1						1	Pyrexia	FLU3~CSL LIMITED~01749211A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359659	10/06/2009	PA	47.0	47		F	10/06/2009	Pt complained of dizziness and nausea. She looked pale, broke out in a sweat. Had a pulse and was still breathing. Pt was in and out of consciousness 3 X w/in 15 min. loss of consciousness lasted no longer than 1 minute. EMT responded and took vitals. All normal. Pt's father came to store to drive her home.									Y	10/06/2009	10/06/2009	0		OTH	PVT		None				1						1	Consciousness fluctuating; Dizziness; Hyperhidrosis; Loss of consciousness; Nausea; Pallor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98432P1~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359660	10/06/2009	TN	68.0	68		F	10/06/2009	Received shot 10-3-09 (Sat. afternoon). Had some itching and redness Sun.10/4/09. Came into store Mon. 10/5/09; upper arm (R) swelling and redness 3-4 inches in shot area from PNEUMOVAX. FLUVIRIN in other arm. Given ADVIL.									Y	10/03/2009	10/04/2009	1		PUB	UNK						1						1	Erythema; Injection site erythema; Injection site swelling; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2A~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0632Y~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359663	10/06/2009	CA	38.0	38		F	10/06/2009	woke for work with headache and extremem fatigue,ended up leaving work early with diarhea that started at about 9 AM. Was lethargic on 10/1/09, and just slept, 10/2 still very lethargic and tired with a headache so stayed down and slept most of the day, by 10/3 head congestion and runny nose started and by 10/4 I developed a fever all day and night with a high of 102, muscles aches, joint stiffness, diarrhea, headache, chilles, sweating, dizzyness when standing, and very very fatigued, same symptoms on 10/5 though less severe causing me to miss work again and sleep all day taking tylenol cold and flu and sleep all day and force fluids and take baths,..today the fever has broken but the headache persists as does the fatigue and joint stiffness, and I missed work again today. I only have a mild cough when I get up and start moving around and am bringing up some dark phlegm but the runny nose stopped yesterday as did the head congestion.My intestines still feel sick though the diarrhea has stopped there is just a lot of flatulence.										09/29/2009	09/30/2009	1		PUB	PUB	nexium 40 mg QD claritin 10 mg QD Asmanex 1 puff QD Seasonique birth control mobic 7.5 mg QD wellbutrin 150 QD singulair 10 mg QD	no	Asthma,allergic rhinitis/seasonal allergies,GERD,			1						1	Chills; Cough; Diarrhoea; Dizziness; Fatigue; Flatulence; Headache; Hyperhidrosis; Increased upper airway secretion; Joint stiffness; Lethargy; Myalgia; Pyrexia; Rhinorrhoea; Sputum increased; Upper respiratory tract congestion	FLUX~UNKNOWN MANUFACTURER~i dont know~UNK~IJ~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359665	10/06/2009	OK	29.0	29		F	10/06/2009	Itchy all over, felt dizzy and very warm, sweaty hands.										10/06/2009	10/06/2009	0		PVT	UNK		None	Medical Cond. - Asthma, Allergies - Sulfa, Zyrtec, Imitrex			1						1	Dizziness; Hyperhidrosis; Pruritus; Skin warm	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359667	10/06/2009	MO	57.0	57		F	09/29/2009	Approx 2 1/2 hr after receiving flu vaccine client had nausea, swelling of eyes, & tongue felt enlarged.  States the next AM, her face & neck was swollen, eyes were red & itchy.  No persistent coughing.  Could speak.  Did not seek medical attention.  Took BENADRYL 50 mg every 4 hours X 4 starting on 9/24/09.  Symptoms resolved.									Y	09/23/2009	09/23/2009	0	None	PUB	PVT	SYNTHROID one every day.	None	None allergic to Aspirin.	increased temp after flu vaccine about 25 yrs ago.~Influenza (Seasonal) (no brand name)~UN~0.00~Patient		1						1	Eye pruritus; Eye swelling; Local swelling; Nausea; Ocular hyperaemia; Paraesthesia oral; Swelling face	FLU3~SANOFI PASTEUR~U3187AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359668	10/06/2009	MO	39.0	39		F	09/30/2009	Injection site tenderness and pain that radiates to the neck. Vaccine give on 9/22/09. Patient is taking MOTRIN and TYLENOL for pain control.									U	09/22/2009	09/22/2009	0	None	OTH	PUB	None	None	None			1						1	Injection site pain; Neck pain	FLU3~CSL LIMITED~07849111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359669	10/06/2009	TX	21.0	21		M	10/01/2009	Received vaccine on Sat 9/26 at 12:00 noon; onset of symptoms a 3hr later; Pt experience 1st stomach cramps / pain later vomiting, diarrhea; loss of appetite, fever (sweating-chills); stomach cramping and diarrhea for 48 hrs; Symptoms subsided by 3rd day.									Y	09/26/2009	09/26/2009	0		OTH	PVT		None		cramping; vomiting; Diarrhea~Influenza (H1N1) (H1N1 (MONOVALENT) (UNKNOWN))~~21.00~Patient		1						1	Abdominal pain upper; Chills; Decreased appetite; Diarrhoea; Hyperhidrosis; Pyrexia; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848PIC~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359670	10/06/2009	NY	27.0	27		F	10/02/2009	Patient reports @ 6:30 pm her chest felt heavy and had a cough. At 845 pm her eyes felt (oily), 9:30 pm eyes were swollen. Still had a heavy chest in AM on 9/25 but all symptoms gone by 4 pm on 9/25.									Y	09/24/2009	09/24/2009	0	None @ this time. She plans to f/u with allergy testing.	PUB	PUB		none	none			1						1	Abnormal sensation in eye; Chest discomfort; Cough; Eye swelling	FLU3~SANOFI PASTEUR~U3205CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359671	10/06/2009	IL	63.0	63		F	10/01/2009	Sore to touch, limited mobility when moved above the head (using ibuprofen). Pain the same as it was on the first day, worse at night. The site is not red or warm to touch.				Y					U	09/15/2009	09/15/2009	0		OTH	PVT	LANTUS; HUMALOG; LISINOPRIL	No	DM, HTN			1						1	Mobility decreased; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~9784P2~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359672	10/06/2009	CA	69.0	69		F	09/15/2009	Pt did not report until 9/4/09 when she came to another Walgreens for a flu shot. She complained of soreness on R arm, resulting from PNEUMOVAX she received on 10/22/08. She said to other pharmacist that the soreness has always been there, still havaday it hasn't gone away - still has soreness.									N	10/22/2008	10/22/2008	0		UNK	UNK		No				1						1	Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~89880~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0619X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359673	10/06/2009	CA	5.0	5		M	09/25/2009	T.C. from mother, states child has a big bump on his son's (L) arm - Referred the patient to clinic for an evaluation ASP.				Y					U	09/23/2009	09/24/2009	1	None	PUB	PVT	None	None	None			1						1	Injection site mass	DTAP~SANOFI PASTEUR~C2957AA~5~UN~LA~DTAP (DAPTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500683P~1~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB336DA~2~UN~RA~HEP A (HAVRIX)~1	USA	Emergency room visit	Influenza
0359674	10/06/2009	MA	85.0	85		M		Patient claims to have gotten pneumo from the flu shots. 10,/26/2009 hospital records from 9/29-10/5/2009. Patient with sx of SOB, chest pain, fever, productive cough with hemoptysis. Tx: IV lasix, O2 at 2l, Telemetry, IV ABX. Dc DX : Bronchitis    ICD-9 codes : 466.0, 786.3, 272.4, 356.9, 414.00, 800, 285.9, v64.06, 428.0, 518.3, 440.20, 401.9					Y	6			U	09/23/2009	09/24/2009	1	Labs: CBC: WBC 13.2, Neutrophils 89.4 both high, Hct 32.9, Hgb 11.5, both low, Bands 35 High, Lymphs 6.4 Low. BMP, total CK 198, high, Blood and Sputum cultures negative, UA WNL Dx studies/xrays: EKG abnormal sinus tach, CXR abnormal, bilateral atelectasis with lower lobe infiltrates, Echo WNL, Nuclear stress test WNL	OTH	UNK			PMH: CAD, HTN, Hyperlipidemia, Chronic peripheral neuropathy Allergies: Morphine, Novacain			1						1	Pneumonia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P1~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0359675	10/06/2009	IA	39.0	39		M	10/06/2009	Swelling, fever, nausea, vomiting, joint pain, visual impaired, fatigue, myalgia. 11/30/09 DC summary received and hosp recs received for date 10/8/09 to 10/12/09. DX: allergic reaction to flumist. Influenza. Presenting sx: pt states received vax and approx 3hrs later c/o sudden swelling around neck, difficulty breathing, the following day pt states face swelling, rash upper torso. Was tx in ER and later returned for worsening of sx. Currently presenting to this ER visit w. myalgias, fever, chills, SOB, weakness. Assessment: fever, rash, facial swelling.				Y	Y	2			N	10/01/2009	10/02/2009	1	CBC; BMP (WBC 13.0; K+ 3.2)	MIL	MIL	BENADRYL; PRILOSEC					1						1	Arthralgia; Blood potassium decreased; Fatigue; Full blood count; Metabolic function test; Myalgia; Nausea; Pyrexia; Swelling; Visual impairment; Vomiting; White blood cell count increased	FLUN3~MEDIMMUNE VACCINES, INC.~500685P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0359676	10/06/2009	MD	48.0	48		F		I received the flu shot 9/22/09. On 9/23/09 my R arm was scarred as if I had been burned. The scab is peeling now. I feel pain when I lay on it sometimes.									Y	09/22/2009	09/23/2009	1		PVT	UNK						1						1	Pain in extremity; Scab; Scar	FLUX~SANOFI PASTEUR~U3201AA~UNK~UN~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359677	10/06/2009	VA	44.0	44		F	10/02/2009	A few hives developed 2 hours after injection. Patient took BENADRYL.									Y	09/30/2009	09/30/2009	0		OTH	UNK						1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98437P1A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359680	10/06/2009	KS	67.0	67		F	10/01/2009	On 9-16-09 small, itchy, fluid filled lumps appeared entire body except for face, palms of hands and soled of feet; pt self treated with OTC hydrocortisone cream. Pt is a retired RN and did not seek medical care. Areas remain on body 9-30-09 but healing scabs									N	09/14/2009	09/16/2009	2		PUB	PUB	Multivitamin; Vit D 3; Gluco/Condro.	None	Sulfa; Penicillin			1						1	Rash generalised; Rash pruritic; Rash vesicular; Scab	FLU3~SANOFI PASTEUR~U3203AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0632Y~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359682	10/06/2009	WV	7.0	7		M	10/01/2009	Injection site and entire upper arm red and swollen.									Y	09/29/2009	09/30/2009	1	None	PVT	OTH	Aspirin 81 mg; PREDNISONE; LISINOPRIL 2.5 mg	Asthma exacerbation	Congenital heart disease			1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U3259FA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359685	10/06/2009	NJ	65.0			F	09/29/2009	Muscle soreness radiating down arm and tingling - heat and slight swelling. Pain continued for 30 minutes / - onward, pallor numbness, hand / fingers, elbow swelling. Upper L chest swelling and pain nausea.				Y						09/29/2009	09/29/2009	0	ER Dx: Ige hematoma - pressing on nerves blood vessels.	OTH	UNK			None; Sulfa drugs			1						1	Chest pain; Haematoma; Hypoaesthesia; Joint swelling; Myalgia; Nausea; Pallor; Paraesthesia; Skin warm; Swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97842P2~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359686	10/06/2009	OK	70.0	70		M		Patient called reports had severe shalciness after injection - Seen at hospital ER.				Y					Y	09/24/2009			Not known	OTH	OTH	Allopurinol, 300mg tab, 1/2 tablet by mouth every day; Aspirin, 325 mg tablet EC, take one tablet by mouth every day as directed; Atorvastatin, 20 mg tab, take one (1) tablet by mouth at bedtime; Furosemide, 20 mg tab, take one (1) tablet b	None	HTN; Diabetes; CAD; Gout; CHF			1						1	Tremor	FLU3~CSL LIMITED~0249211A~4~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~0627X~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0359688	10/06/2009	LA	54.0	54		F	09/30/2009	Arm sore first day next day 5pm quarter size rash spots around injection site, felt slight S.O.B- To seem + given Prednisone 10mg x 3 + Cortisone cream at site doing fine subsided no compilations.				Y					Y	09/28/2009	09/29/2009	1		PUB	PUB	Claritin	None	Stated seasonal allergies			1						1	Dyspnoea; Injection site rash; Pain in extremity	FLU3~CSL LIMITED~05649111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0359689	10/06/2009	NE	57.0	57		F		9/22 + 9/23 Light headed, 7 AM - 9/24 Sat. Light headed - server - can't walk straight, felt like left side of head - empty, vomited 1 PM, Sun. 9/25 - Felt a little better, Mon 9/26 - Didn't got to  work - still light headed, not safe to drive, 9/27 Return to work, fell better.									Y	09/21/2009	09/22/2009	1		OTH	OTH	Insulin - NPH + HUMALOG; ALTACE; VYTORIN; Vitamin B-6; B12; Folic Acid		Type 1 diabetes 46yr.; Heart (2) Quad -Bi passes; Neuropathy			1						1	Dizziness; Feeling abnormal; Gait disturbance; Vomiting	FLU3~SANOFI PASTEUR~U3187AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359690	10/06/2009	OR	31.0	31		F	09/30/2009	Received vaccine at 2:30 PM on 9/23/09.  Developed Fever at 8:00 PM on 9/23/09.  Fever peaked at 103 degrees at 10:00 PM, was treated with TYLENOL.  Experienced severe chills and body aches.  Remained febrile at 100 degree F on 09/24/09.  Awoke 9/25/09 asymptomatic and feeling fine.									U	09/23/2009	09/23/2009	0	None	PVT	PVT	None	None	None			1						1	Chills; Pain; Pyrexia	FLU3~CSL LIMITED~02249211A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359695	10/06/2009	MA	84.0	84		F	09/30/2009	Pt said she woke up next morning with diarrhea, hands swelling, trouble swallowing and breathing. Went to ER. MD diagnosed allergic reaction to FLUVIRIN. Pt took BENADRYL and said she was feeling better. Call was 24 hours after shot.				Y					Y	09/29/2009	09/30/2009	1	Pt reported ER MD diagnosed FLUVIRIN allergic reaction. Has had flu shot for last 5 years without reaction.	OTH	PUB	METOPROLOL; DIOVAN; SIMVASTATIN; NEXIUM; aspirin 325 mg; ZYRTEC	None	Quite a few allergies. PENICILLIN; sulfa; scallops; hay fever; pets			1						1	Diarrhoea; Dysphagia; Dyspnoea; No reaction on previous exposure to drug; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P1~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359696	10/06/2009	MA				U	09/30/2009	When pt woke next morning area was red, swollen, hot to touch with a lump size of quarter.									Y	09/28/2009	09/29/2009	1	None	PUB	PUB	BP and cholesterol.					1						1	Erythema; Nodule; Skin warm; Swelling	FLU3~SANOFI PASTEUR~U3188AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359698	10/06/2009	IA	14.0	14		F	09/27/2009	Pt's mother called next morning and stated pt had stiff neck and difficulty turning head. Mother observing and treating with NSAID and TYLENOL. At 14:30 spoke with pt, feeling much better with little stiffness. At 16:00 only minor stiffness, mostly recovered. Told to contact MD if not getting better or getting worse, faxed MD.									Y	09/26/2009	09/27/2009	1		OTH	OTH		None				1						1	Musculoskeletal stiffness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P1~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359699	10/06/2009	HI	54.0	54		M	09/30/2009	Total body rash within 2 hours, began scratching within 30 minutes. Response from CLARITAN 10 mg till it begins to wear off then rash returns, retreatment with same, also to begin HC 1% topically.									U	09/26/2009	09/26/2009	0		OTH	OTH	SINGULAIR; TOPIRAMATE; ASMANEX; PRO AIR HFA		AMBIEN; PENICILLIN; asthma			1						1	Pruritus; Rash generalised	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960395P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359701	10/06/2009	HI	55.0	55		F	09/30/2009	Headache; pressure in head; between upper shoulders and neck - necessitating  had to sit down, nausea, no emesis, TX with TYLENOL XL (1gm) q 4 hrs daytime x 2 days.									Y	09/26/2009	09/26/2009	0		OTH	PVT	ACIPHEX 20 mg, BONIVA 150 mg	None				1						1	Headache; Musculoskeletal pain; Nausea; Neck pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960355P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359702	10/06/2009	TX	46.0	46		F	09/27/2009	Site of injection became hot and somewhat swollen the eve of injection. Patient passed out and had seizure. Took TYLENOL and BENADRYL after being revived and feels better.									Y	09/26/2009	09/26/2009	0	None taken	OTH	PVT	Not known	None	Asthma			1						1	Convulsion; Injection site swelling; Injection site warmth; Loss of consciousness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848P1C~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0625Y~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359704	10/06/2009	IN	63.0	63		M	09/28/2009	Pt came into store and complained of a pimply-like rash on left side of body with associated itching all over rash area. Stated it started on left shoulder and then spread over chest and started on left side of body. Treated by Dr. with a MEDROL dose pack. Pt. stated rash started on Sat 9/19. Presented Rx on 9/24				Y					U	09/15/2009	09/19/2009	4		OTH	PUB		None	Unknown			1						1	Rash papular; Rash pruritic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97842P2~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359705	10/06/2009	LA	31.0	31		F	10/02/2009	09:45 received her 1st dose of FLULAVAL ever. 45 minutes later, started itching all over. Reported to Emp Wellness, Dr order nurse to give her 50 mg BENADRYL IM. Pt had epi-pen for other allergies but did not use it or want us to use ours.									Y	09/11/2009	09/11/2009	0	None	PVT	OTH	None	None	Allergic to NSAIDS, tomato, strawberry			1						1	Pruritus generalised	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA276AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0359707	10/06/2009	FL	72.0	72		F	09/30/2009	Patient went to emergency room, I got call from ER stating patient had allergic reaction, facial swelling and swelling at site of injection.				Y					U	09/30/2009	09/30/2009	0	Unknown	OTH	PUB	Unknown	None	None			1						1	Hypersensitivity; Injection site swelling; Swelling face	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848P1C~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359710	10/06/2009	SC	74.0	74		F	09/29/2009	Dizziness, lightheadedness immediately after vaccine. Vertigo (spinning sensation) same night and 3 nights thereafter. Numb and painful and swollen left hand and wrist 2 days later. All symptoms have gone except dizziness still present.				Y					U	09/19/2009	09/19/2009	0	Dr visit on Monday 9/21. Dr said drink fluids, get rest.	OTH	PVT		None	None			1						1	Arthralgia; Dizziness; Hypoaesthesia; Immediate post-injection reaction; Oedema peripheral; Pain in extremity; Vertigo	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2A~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359711	10/06/2009	SC	56.0	56		F	09/28/2009	Skin rash and swelling on left arm.				Y					Y	09/19/2009	09/20/2009	1	As per pt. MD found pt allergic to FLUVIRIN, even though she received it last year without any allergic reaction.	OTH	PVT		No	No			1						1	Allergy to vaccine; Oedema peripheral; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P2~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359712	10/06/2009	WI	8.0	8		M	10/06/2009	Pt developed hives/evoking into EM rash within 24 hours of FLUMIST. Treated with HYDROXYZINE and PREDNISONE.				Y					Y	10/01/2009	10/02/2009	1	None	PVT	PVT	SINGULAIR; ZYRTEC	Diarrhea for 1 day	Environmental allergies			1						1	Erythema multiforme; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500675P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0359713	10/06/2009	CA	47.0	47		F	10/02/2009	Headache one hour after injection. Given acetaminophen and released. Later during day-evening-had medicinal taste in mouth and projectile vomiting. Then no other symptoms.									Y	10/01/2009	10/02/2009	1	None	OTH	PVT	LEVOTHYROXIN; VICODIN as needed, not taking					1						1	Dysgeusia; Headache; Vomiting projectile	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97850P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359714	10/06/2009	MO	20.0	20		F	10/05/2009	90 seconds after L deltoid injection patient developed blotchy redness. Initially on chest, moving to neck and face. Patient felt faint. Treatment consisted of having patient lie down, legs elevated, cold compress on forehead. After 30 minutes patient okay.									Y	10/05/2009	10/05/2009	0	None	OTH	PVT		None	None known			1						1	Dizziness; Erythema; Immediate post-injection reaction; Rash macular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359715	10/06/2009	IL	22.0	22		F	10/02/2009	Post injection, employee c/o pain and tingling. Upon evaluation site was warm and swollen. Site iced for a few minutes. Employee was offered outside treatment and declined. Employee was informed if symptoms persisted or worsened to let manager or medical staff know.									Y	10/02/2009	10/02/2009	0	None	OTH	PVT	None	None	Mitral valve regurgitation/heart murmur (systolic)			1						1	Injection site swelling; Injection site warmth; Pain; Paraesthesia	FLU3~CSL LIMITED~078491UA~1~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359716	10/06/2009	MA	2.0	2	.0	M	10/06/2009	Bells Palsy				Y					U	09/27/2009	10/01/2009	4	None	PVT	PUB	No	No	No			1						1	Facial palsy	FLUN3~MEDIMMUNE VACCINES, INC.~500713P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0359717	10/06/2009	CA	82.0	82		F	10/05/2009	The day after she had the usual malaise/ joint pain (especially elbow/ arm).  The biggest concern is that she is having recent memory loss.  Her husband is a retired doctor and says that she definitely had a CNS event.									U	09/30/2009	10/01/2009	1	None	OTH	UNK	PREMARIN; VESICARE.	None	None			1						1	Amnesia; Arthralgia; Malaise	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359718	10/06/2009	MN	69.0	69		M		Patient reported on Friday about 5:00 PM (9/11/09) he had a fever 103 degrees, achy joints, headache, and his eyes hurt. The day after he felt fine during the day and a temp of 100-101 in the evening. Two days post immunization he had no fever but an 8 inch patch of redness on the right arm lower than where shot given. No treatment, no doctor was seen.									Y	09/11/2009	09/11/2009	0		OTH	UNK		None				1						1	Arthralgia; Body temperature increased; Erythema; Eye pain; Headache; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~47846P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0627Y~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359719	10/06/2009	WI	18.0	18		M	09/28/2009	Within 3 mins client experienced spots, sweating. Post awareness, and had seizure-like Sx ie mouth movement and arm movements lasting < 10sec.									Y	09/28/2009	09/28/2009	0	None	PUB	PUB		None	None			1						1	Altered state of consciousness; Convulsion; Dyskinesia; Hyperhidrosis; Visual impairment	FLU3~SANOFI PASTEUR~U320AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359720	10/06/2009	CA	38.0	38		M		Swelling all confined to the extremity to which the immunization was given. Roughly a little bigger than quarter size.									Y	09/26/2009	09/26/2009	0		UNK	UNK			None			1						1	Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359724	10/06/2009	NY	48.0	48		F	10/05/2009	C/o swollen lip (upper) and cheeks, developed after he went to sleep, woke up with tingling in lip and face. Started MEDROL po, BENADRYL po --> ER SALU-MEDROL. No allergies, has flu vaccine yearly, never any reaction.									Y	09/21/2009	09/22/2009	1		PVT	UNK		No	None			1						1	Lip swelling; Paraesthesia; Paraesthesia oral; Swelling face	FLU3~SANOFI PASTEUR~U3253CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359725	10/06/2009	VA				U		Swelling left deltoid, purpura left arm to Antecubitar.										10/05/2009	10/05/2009	0	CBC	PVT	PVT						1						1	Full blood count; Injection site swelling; Purpura	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~~2~~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359726	10/06/2009	MA	66.0	66		F	10/05/2009	Received injection on 10/01/2009. Immunization report of pain in upper arm. Next day inner  aspect of arm erythematous, warm and swollen, painful. Has slowly resolved.									Y	10/01/2009	10/01/2009	0		PUB	PUB		None	Allergies to Make up other resp. allergies			1						1	Erythema; Injection site pain; Oedema peripheral; Pain in extremity; Skin warm	FLU3~SANOFI PASTEUR~1435X~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~U3188AA~2~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359728	10/06/2009	CA	59.0	59		M	10/01/2009	6 PM sore throat - chest - discomfort - achy and nausea - chills - dark urine -eyes red and discharge with puss type drainage - Injection site not red or sore - also severe headache.									Y	09/29/2009	09/29/2009	0	None	PUB	UNK		None	VICODIN for back pain			1						1	Chest discomfort; Chills; Chromaturia; Eye discharge; Headache; Nausea; Ocular hyperaemia; Oropharyngeal pain; Pain	FLU3~SANOFI PASTEUR~U3193~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359729	10/06/2009	PA	49.0	49		F	10/06/2009	Employee received FLUVIRIN on 10-2-09 apx. 11:00. After lunch rt. eye lost partial vision and rt. ear ringing. B/P increased-base usually 140/80 ranged 150-160/90. Sight returned, 3 day still had rt. ear ringing and B/P increased apx 10 diastolic and systolic.									Y	10/02/2009	10/02/2009	0	None	MIL	MIL	None	None	None			1						1	Blindness; Blood pressure increased; Tinnitus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98437P1A~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359730	10/06/2009	NY	34.0	34		F	10/05/2009	Developed nausea 10/3/09 and vomited with diarrhea x 4 times on 10/3/09. T-99.1. Chills, backache. Improved 10/4/09 but cont with nausea throughout 10/4/09 and AM 10/5/09.									Y	10/02/2009	10/03/2009	1	None	PUB	PVT	QUININE; MOTRIN 800 mg; ALBUTEROL prn	None	Asthma			1						1	Back pain; Chills; Diarrhoea; Nausea; Vomiting	FLU3~SANOFI PASTEUR~U3205CA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359731	10/06/2009	MA	65.0	65		F	10/06/2009	9/8/09 left upper arm tingling, radiating up left side of neck to jaw, started 10 minutes after vaccine in left arm. Lasted several hours, faded out. Headache started around same time and continued to 14:00 9/8/09.									U	09/07/2009	09/07/2009	0		OTH	OTH						1						1	Headache; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359733	10/06/2009	AL	13.0	13		F	09/19/2009	Administered flu shot, applied bandaid, patient said she felt dizzy, I told her to remain in seat, she leaned over & passed out. She was out for about 5-10 seconds. Mother stated she had passed out 4-6 wk ago sitting at beauty parlor. EMS was called & responded. Patient was checked out in ER and said she was OK.				Y					Y	09/19/2009	09/19/2009	0		OTH	PVT		None/She was on her period	Had fainted once in last 4-6 wks.			1						1	Dizziness; Loss of consciousness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848P1A~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359734	10/06/2009	NC	28.0	28		F	09/25/2009	Adverse event, throat tightness at 3:10 pm 9-25-09. Administration of Fluvirin given at 2:40pm 9-25-09 Epi Pen 0.3mg IM deltoid given and transported to hospital at 3:30 pm 9-25-2009.				Y					U	09/25/2009	09/25/2009	0		UNK	UNK						1						1	Throat tightness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359735	10/06/2009	NJ	22.0	22		M	09/28/2009	Pt passed out on floor. He was dizzy for 30 seconds or 40 secs. EMS came and he had pulse OK. EMS took him to hospital.				Y					Y	09/28/2009	09/28/2009	0	He was taken to hospital	OTH	OTH						1						1	Dizziness; Loss of consciousness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359737	10/06/2009	CA	16.0	16		F	09/30/2009	16yo female who presented 7 days after vaccine with 4-6 d of body aches, lethargy and initiation of headaches (Hx of stress associated H. A. C in past) - No physical or labs findings.										09/23/2009	09/24/2009	1		PVT	PVT		None	Stress related headaches			1						1	Headache; Lethargy; Pain	FLUN3~MEDIMMUNE VACCINES, INC.~500677P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~MERCK & CO. INC.~AHAVB326AA~2~UN~LA~HEP A (VAQTA)~1|HPV4~MERCK & CO. INC.~0653X~1~UN~LA~HPV (GARDASIL)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B046DA~1~UN~LA~TDAP (BOOSTRIX)~1	USA		Influenza
0359738	10/06/2009	MN	78.0	78		F	09/22/2009	Patient reported on Monday, Sept. 14th. that she experienced joint pain the evening that she received the injections. The pain continued through the next day. No fever, no treatment. She felt better the next day with no further complaints.									Y	09/09/2009	09/09/2009	0		OTH	UNK		None				1						1	Arthralgia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0627Y~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359740	10/06/2009	IL	72.0	72		F	10/07/2009	Patient complains of arm pain and decreased movement or ability to move arm in which shot was given.  There has been no treatment by health care facility at this time.									U	10/06/2009	10/06/2009	0	None to date.	OTH	OTH		None	None			1						1	Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U3214AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359741	10/06/2009	WA	11.0	11		M	10/06/2009	20 min past first ever flu vaccination, pt. experienced light headiness, pale, racing heart, tickly throat, gave pt, 10ml BENADRYL elixir, laid elevated, feet up , ice pack to neck, did not feel better, throat felt obstructed called 911, transported to ER, discharged home.				Y					Y	10/06/2009	10/06/2009	0		OTH	PVT						1						1	Dizziness; Pallor; Palpitations; Throat irritation; Throat tightness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98441P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359743	10/06/2009	OH	60.0	60		F	10/06/2009	Patient had FLULAVAL Nov 2009-20010 and PENUMOVAX 23 2.5 mcg/0.5ml in same arm and same day. Complained of arm pain and leg pain.									U	10/02/2009	10/02/2009	0		OTH	PVT	Unknown					1						1	Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA259AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~082Y~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359744	10/06/2009	CA	35.0	35		F		Soreness, redness, slight swelling at injection site, a little itchiness at injection site. Slightly warm at injection site.									U	10/05/2009	10/06/2009	1		UNK	UNK		None				1						1	Injection site erythema; Injection site pain; Injection site pruritus; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P1~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359758	10/06/2009	WA	61.0	61		F	10/06/2009	Administered 10/1/09 (L) arm - Friday 10/2 - sore throat, numb right arm and fingers, right thumb still numb, lips and tongue numb off and on. Suggested Dr visit - Neurologic?									U	10/01/2009	10/02/2009	1		UNK	UNK	PREVACID; PAXIL; Gemfibrozil	None				1						1	Hypoaesthesia; Hypoaesthesia oral; Oropharyngeal pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97849P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359759	10/06/2009	NM	63.0	63		M	10/06/2009	Patient called on 10/5/09 reported malaise, muscle aching and ability to not be able to think clear, when I talked to him on 10/6/09 he said he was feeling better.									Y	09/29/2009	09/29/2009	0		OTH	PVT			Advanced asthma			1						1	Malaise; Myalgia; Thinking abnormal	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97842P2~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359760	10/06/2009	MN	1.8	1	.8	F	10/06/2009	Child given adult influenza dose instead of pediatric dose.									U	10/06/2009				PUB	PVT		None				1						1		FLU3~SANOFI PASTEUR~U3186AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359761	10/06/2009	WA	56.0	56		F	10/06/2009	Pt mentioned to staff RPH on 10-5-09 who in turn told me to call her on 10-6-09. Pt said she had pain or soreness in her right arm prior to getting the shot but it turned into extreme soreness/pain after getting the flu shot. She said she chose the right arm because her right arm was already bothering her so she figured she'll get the shot in her right arm as well, that way she have one good arm. She said, she gets soreness in her right arm because she has a bone spur- calcific tendonitis. She saw orthopedic Dr and received DARVOCET and CELEBREX on 10-5-09.									Y	09/28/2009	09/29/2009	1	History of bone spur in right arm. Pt did not mention during vaccination	UNK	UNK		Calcific tendonitis (bone spur); Existing soreness in right arm	Bone spur right arm			1						1	Condition aggravated; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P1~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359762	10/06/2009	HI	2.0	2	.1	M	10/06/2009	Vomiting									U	10/05/2009	10/06/2009	1		PVT	PVT		None	None			1						1	Vomiting	FLU3~SANOFI PASTEUR~UT3173HA~2~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359764	10/06/2009	FL	42.0	42		M	10/06/2009	Patient returned feeling lightheaded and sweaty. Started to faint, gave 1 EPIPEN injection, laid patient on floor. Call paramedics. Patient taken to hospital. Talked to ER doctor.				Y					Y	10/06/2009	10/06/2009	0		OTH	PVT		None	None			1						1	Dizziness; Hyperhidrosis; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97844P1~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359765	10/06/2009	NE	8.0	8		F	10/06/2009	Broke out around 18:00 with itching and rash. Dark red rash on body. Extremities and face looks like welts.									Y	10/05/2009	10/05/2009	0	None	PVT	PVT	None	none	None			1						1	Pruritus; Rash erythematous; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500673P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0359766	10/06/2009	CO	52.0	52		F	10/06/2009	Blood sugar fluctuates up and down, body temperature fluctuates up and down. Patient sweats a lot.									N	10/01/2009	10/01/2009	0		OTH	OTH	TOPAMAX; morphine IR 30 mg; fentanyl patches; CYMBALTA	None	iodines; CODEINE; VALIUM; diabetes; high blood pressure			1						1	Blood glucose fluctuation; Body temperature fluctuation; Hyperhidrosis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359770	10/06/2009	NY	42.0	42		F	10/06/2009	About 1 hour after receiving immunization pt. reported experiencing itching @ the site of injection & a hive erupted.  She later developed a very itchy hive under her right eye.  The next morning she called her physician who advised her to take a BENADRYL - which she did.  She reported that it helped w/itching.									Y	10/01/2009	10/01/2009	0	None	PUB	PUB	ZYRTEC OD; ADVAIR - one pill daily.	None	Allergies to cats & PCN, Sulfa drugs; IVP dye.			1						1	Injection site pruritus; Injection site urticaria; Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA255BB~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0359772	10/06/2009	NH	0.55	0	.6	M	10/06/2009	Temperature 101.9 rectal.  Hives.  Rx ROCEPHIN 350 mg IM.				Y						09/28/2009	09/29/2009	1	Increased WBC 21.9;  Blood culture - no growth.	PVT	PUB	AMOXICILLIN (Day 10).	Resolving ROM & bronchiolitis				1						1	Blood culture negative; Body temperature increased; Urticaria; White blood cell count increased	DTAPIPVHIB~SANOFI PASTEUR~C3433AA~3~IM~UN~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~UT3178FA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~0890Y~3~IM~UN~HEP B (RECOMBIVAX HB)~1|PNC~PFIZER\WYETH~057304~3~IM~UN~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0181Y~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA	Emergency room visit	Influenza
0359777	10/06/2009	TX	13.0	13		M	10/06/2009	Fever 101.2, weak and fatigued last noc and this AM.									Y	10/05/2009	10/05/2009	0	flu (-); strep (-)	PVT	PUB		None				1						1	Asthenia; Fatigue; Influenza serology negative; Pyrexia; Streptococcal identification test negative	FLU3~SANOFI PASTEUR~UT3175AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359780	10/06/2009	NE	35.0	35		F	10/03/2009	At 3:30 PM felt constriction in throat, by 5:30 PM eyes were swollen shut and felt fatigued. Took BENADRYL and ADVIL and went to sleep. Awoke at 8:30 AM groggy-as BENADRYL wore off-symptoms returned, took more BENADRYL and ADVIL after speaking with physician.				Y					Y	09/29/2009	09/29/2009	0	None	PUB	PVT		None	None			1						1	Eye swelling; Fatigue; Somnolence; Throat tightness	FLU3~SANOFI PASTEUR~U3204AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359781	10/06/2009	NY	40.0	40		F	10/07/2009	Pt states became dizzy and nauseous after flu shot - states her face was hot and weird.				Y					Y	10/05/2009	10/05/2009	0		PVT	PVT	None	History of Asthma	Asthma; states allergy to shell fish			1						1	Dizziness; Feeling abnormal; Feeling hot; Nausea	FLU3~SANOFI PASTEUR~U3253DA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359782	10/06/2009	TX	43.0	43		M	10/10/2009	Started with itching - generalized, no rash c/o not feeling well. 7 days later - c/o twitching to eyes - Referred to ER/Primary  on 10/16 - with twitching/unable to close Lt eye.				Y						09/21/2009	09/22/2009	1	CBC	PUB	UNK		None	None			1						1	Blepharospasm; Eye disorder; Full blood count; Malaise; Pruritus generalised	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA4568A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0358594	10/07/2009	OR	19.0	19		F	10/02/2009	Initial report received on 24 September 2009 from a health care professional. This case pertains to one of a cluster of three patients involving misuse. The same reporter provided information regarding three patients who had been exposed to an investigational product involving a clinical trial sponsored by Sanofi Pasteur, but who were not enrolled in the study. All three patients had received investigational product instead of a marketed influenza vaccine. Information regarding the other two patients is reported in cases 2009-04113 and 2009-04157. A healthy 19-year-old pregnant female, had received a first intramuscular right buttock injection of investigational product, INFLUENZA VIRUS VACC USP TRIVAL A&B HIGH DOSE, SUBVIRION-U (lot number UD12307) on 23 September 2009 at 15:30 hours. The right buttock is not a recommended site of administration for this product. Obstetrical history included three prior pregnancies that resulted in one live birth with no congenital anomalies, one elective termination of pregnancy and one spontaneous abortion. The patient's expected date of delivery is 31 December 2009. Prenatal tests included serologies performed on 01 July 2009, and ultrasound on 27 August 2009 that were normal. The patient has not experienced any adverse events. Documents held by sender: None.				Y					U	09/23/2009			Prenatal testing included serologies on 01 July 2009 and ultrasound on 27 August 2009 that were normal.	PVT	PVT			No concurrent illnesses, or use of other medications at time of vaccination on 23 September 2009 at 15:30 hours. Obstetrical history includes three prior pregnancies that resulted in one live birth with no congenital anomalies, one elective termination of pregnancy, and one spontaneous abortion.		200904114	1						2	Drug exposure during pregnancy; Drug administered at inappropriate site; Drug exposure during pregnancy; Serology normal; Ultrasound scan normal; Wrong drug administered	FLU3~SANOFI PASTEUR~U012307~UNK~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~UD12307~1~IM~GM~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0359602	10/07/2009	MN	75.0	75		M	10/09/2009	GUILLAIN-BARRE Syndrome. Ascending paralysis. 9-26-09 onset, to present (10-7-09). IVIG - treatment.  10/19/09 Physician fax received for date of service 10/12/09.  Dx:  Death secondary to Guillain-Barre Syndrome. Assessment:  Intubated due to GBS.  EMG showed denervation distally.  Due to increased neuronal injury and poor prognosis (also coupled with post-Polio syndrome) the family decided to extubate the patient.					Y				U	09/24/2009	09/26/2009	2	CT head; Neurologic Evaluation; EMG; Campylobacter Stool-neg; Hepatitis-neg. 10/19/09 Physician fax received for date of service 10/12/09.  Labs and Diagnostics:  EMG:  Denervation distally.	PVT	PVT	LIPITOR; Aspirin; Multivitamins; VICODIN; LEVAQUIN	None	Polio with kyphoscoliosis and atrophy LL extremity and L arm; Prostate carcinoma; Basal cell carcinoma of the skin; kidney stones. 10/19/09 Physician fax received for date of service 10/12/09.  PMH:  Post-Polio syndrome.			1						2	Abasia; Lumbar puncture; Blood product transfusion; Computerised tomogram head; Electromyogram; Guillain-Barre syndrome; Helicobacter pylori identification test negative; Hepatitis viral test; Neurological examination; Viral test negative	FLUX~SANOFI PASTEUR~U3192AA~2~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U3192AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0359655	10/07/2009	AZ	64.0	64		M	10/07/2009	Began to develop muscle weakness in his extremeties ~24 hrs after the vaccination. Was taken to the ER, where they found a markedly elevated BP. This was the focus of the treatment. He was hospitalized for 3 days. During this time, the muscle weakness progressed to the point where ambulation was difficult. After discharge, a neurologist diagnosed Guillian Barre Syndrome. The pt was told recovery would take months and he may not regain all his strength.				Y	Y	3			U	09/16/2009	09/17/2009	1	Labs CT head/brain CXR Sinus xray Transthoracic echo Doppler of carotid arteries  All tests were essentially wnl.	PVT	PVT	none	none	Benign essential htn Hyperlipidemia Irritable bowell syndrome Cataracts Posterior vitreous detachment			1						2	Fatigue; Guillain-Barre syndrome; Hypertension; Muscular weakness; Paralysis; Blood pressure increased; Chest X-ray normal; Computerised tomogram head; Echocardiogram; Face and mouth X-ray normal; Gait disturbance; Guillain-Barre syndrome; Muscular weakness; Scan brain; Ultrasound Doppler; Ultrasound Doppler normal	FLU3~SANOFI PASTEUR~U3211AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U3211AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0359708	10/07/2009	NY	48.0	48		M	10/07/2009	Severe fever, muscle aches, itchy eyes Fever 101.2 at 6 AM, took 500 mg Tylenol									Y	10/06/2009	10/07/2009	1	None	UNK	PVT	None	No	None			1						1	Eye pruritus; Myalgia; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~276AD~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0359709	10/07/2009	NY	31.0	31		F	10/07/2009	Note: pt received vaccine 9/11 but did not report any adverse event to me until she returned from a trip 9/30 and emailed me.  According to her email, she had red itchy hives all over my body, my throat was itchy and I felt generally weird all over.  Benadryl took care of it eventually.  She said the hives occurred within two hours of the vaccine, and resolved completely within 4 hours of taking diphenhydramine.  she has received previous flu vaccines without incident.  all of the equipment we used is latex free.									Y	09/11/2009	09/11/2009	0	none -- all follow up on this has been through email.	PVT	PVT	oral contraceptive anti-anxiety medication	none	reports a history of a mild (non-anaphylactic) latex allergy, otherwise no major medical issues at time of vaccination.			1						1	Erythema; Feeling abnormal; No reaction on previous exposure to drug; Pruritus; Throat irritation; Urticaria	FLU3~CSL LIMITED~02249211A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359742	10/07/2009	CA	39.0	39		F	10/06/2009	Pt returned to our pharmacy stating that she got the flu shot on 9/18/09 and she was concerned about a bruise on her arm and soreness/tenderness where the injection was given. She denied any signs of difficulty breathing, N/V, fever, dizziness, hives, hoarseness or wheezing. Pt did mention that bruises appeared to get smaller in size compared to day 1. Advise if she experiences any of the above mentioned symptoms to consult her physician ofc. Instructed pt to take ibuprofen with food to alleviate any pain and inflammation at the injection site.									U	09/18/2009	09/21/2009	3		PUB	PVT	No	No	No			1						1	Injection site haematoma; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848P1C~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359746	10/07/2009	OK	5.0	5		M	10/07/2009	large area of redness and itching at injection site. Treated with Benadryl and Cortisone cream.									Y	10/03/2009	10/04/2009	1	None	PVT	UNK	None	None	None			1						1	Injection site erythema; Injection site pruritus	FLUX~UNKNOWN MANUFACTURER~~1~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359748	10/07/2009	IL	38.0	38		F	10/07/2009	APPROX 4.5 HOURS AFTER ADMINISTRATION OF VACC. I DEVELOPED SUDDEN ONSET OF CHEST PAIN,WITHIN 30MIN-LUNG PAIN/PRESSURE/BURNING,WITHIN 30MIN TIGHTENING/BURNING OF THROAT AND THICKENING OF THE TONGUE/TINGLING LIPS AND BRIGHT RED BURNING OF EYES				Y					Y	10/02/2009	10/02/2009	0	CT OF CHEST, MULTIPLE LAB WERE ORDERED, EKG  MEDICATION ADMINISTERED WAS BENEDRYL AND SOLUMEDROL  IV	PVT	UNK		NONE	NONE			1						1	Chest discomfort; Chest pain; Computerised tomogram; Electrocardiogram; Eye irritation; Laboratory test; Ocular hyperaemia; Paraesthesia oral; Throat irritation; Throat tightness; Tongue disorder	FLU3~CSL LIMITED~09249111A~UNK~IM~~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0359749	10/07/2009	MD	12.0	12		F	10/07/2009	Hives on face and neck for 5 days; treated with Benadryl									Y	09/25/2009	09/25/2009	0	None	MIL	MIL	Claritin	None	Allergy to Sulfa			1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0359750	10/07/2009	AZ	66.0	66		F	10/07/2009	Chest pain. Went to ER. Diagnosed with a heart attack.  10/13/09 ICD-Codes received: 788.50 Unspecified chest pain, 107.1 Subendocardial infarction, 414.01 Cornary atherosclerosis, 275.2 Disorder of magnesium metabolism, 276.8 Hypopotassemia, 281.9 Unspecified deficiency anemia, 272.4 Unspecified hyperlipemia, 564.1 Irritable bowel syndrome, 356.9 Peripheral neuropathy, 715.90 Osteoarthrosis, 305.1 Tobacco use disorder, V58.65 Long term use of steroids, V58.66 Long term use of aspirin, V45.82 Percutaneous transluminal coronary angioplasty status, V43.64 Hip joint replacement status.11/30/2009 MR and DC summary for 10/4-10/6/2009,  DC Dx Chest pain    patient admitted with chest pain, patient had cardaic cath after abnormal nuclear stress test.			Y	Y	Y	3			Y	10/03/2009	10/04/2009	1	labs: CBC, CMP, Lipase, D-dimer, PT, PTT normal/neg	UNK	UNK		Hx of CAD with stent in 2000	PMH: CAD, HTN, SLE Allergies: NKDA			1						1	Chest pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA2658AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening,Hospitalisation	Influenza
0359752	10/07/2009	OH	68.0	67		F	10/07/2009	redness and warmth of (left) deltoid region. Warm compress applied.										10/05/2009	10/07/2009	2		UNK	UNK		no	mastectomy of left side; allergy to aspirin;			1						1	Injection site erythema; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA256AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0359753	10/07/2009	FL	43.0	43		F	10/07/2009	WHEEZING, CHEST TIGHTNESS, SEVERE CONGESION, BLOODSHOT EYES				Y					Y	09/17/2009	09/17/2009	0	NONE	PUB	PVT		NO	NO			1						1	Chest discomfort; Ocular hyperaemia; Upper respiratory tract congestion; Wheezing	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359754	10/07/2009	WV	61.0	61		M	10/07/2009	Weak, high fever (103.7 on its way down, don't how high it had gotten to), head ache, body aches, chills, nausia, dizziness, fast heart rate (122 at the hospital ER), hard to breath, pale.				Y					Y	10/05/2009	10/05/2009	0	Numerous blood tests, urine test, chest x-rays, complete physical exam by doctor. Ruled out any other infection or disease.	UNK	UNK	Atenolol, simvastatin, lisinopril, glipizide, aspirin, flunisolide, asmanex, foradil, combivent (ipratopium bromide and albuterol sulfate).How the hell do I know what vaccine they used???	NO	Environmental allergies, Heart Disease (CAD), Diabetes, High blood pressure (control with meds), Liver Disease, Asthma.			1						1	Asthenia; Blood test; Chest X-ray; Chills; Culture urine; Dizziness; Dyspnoea; Headache; Heart rate increased; Nausea; Pain; Pallor; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0359755	10/07/2009	NE	6.0	6		M	10/07/2009	3x4 hard red warm swollen area				Y						10/06/2009	10/06/2009	0		PVT	PVT		no	none			1						1	Erythema; Induration; Skin warm	FLU3~SANOFI PASTEUR~u3193aa~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359756	10/07/2009	MD	16.0	16		M	10/07/2009	Temperature 102.8 fahrenheit with warm, red, raised area at injection site.  Seen by primary care doctor on 10/05 and started on Amoxicillin.  Improved, but still low grade temp (100.6) on 10/6 in the evening.  Arm still red at injection site.				Y					Y	10/02/2009	10/04/2009	2		UNK	PVT	Synthroid, lamotrigine	No	Malignant ependymoma in infancy resulting in right hemispherectomy.  This resulted in cerebral palsy, mental retardation and visual impairment.			1						1	Body temperature increased; Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3192AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359757	10/07/2009	NY	42.0	42		F	10/07/2009	Started at 430pm with hives and swollen lips, writer took 50 mg benadryl.  Next morning 6:00 AM started with  nausea, vomiting, fever 101.5f, swollen joints and very weak muscles.				Y					N	10/02/2009	10/02/2009	0	None	PUB	UNK		None	Allergies to compazine, Contrast dye, morphine and codiene Intolerance to wheat/yeast Medical conditions, depression, hypertension and hypothyroid			1						1	Joint swelling; Lip swelling; Muscular weakness; Nausea; Pyrexia; Urticaria; Vomiting; Back pain; Body temperature increased; Myalgia; Nausea; Urticaria; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~96033 4P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~96033 4P~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0359784	10/07/2009	GA	41.0	41		F	10/05/2009	Dizziness and headache started 20 mins after administration of vaccine.									Y	09/30/2009	09/30/2009	0	BP 139/92 after 30 minutes 119/84 symptoms resolved	PUB	PVT	None	None	None			1						1	Dizziness; Headache	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA255BA~1~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0359785	10/07/2009	TX	66.0	66		M	10/07/2009	Swelling and pain in right deltoid area approximately 6 hours after injection. Patient reports pain at time of injection. Pain and swelling getting worse. Nurse said to ice down arm and take TYLENOL.									N	10/05/2009				OTH	OTH						1						1	Injection site pain; Injection site swelling	FLU3~CSL LIMITED~07849111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359799	10/07/2009	AZ	24.0	24		F	10/07/2009	Pain at injection site 2 days 101+ fever at 9 hrs post vaccination followed by chills & aches unresolved w 200mg ibuprofen.									Y	10/05/2009	10/05/2009	0	N/A	PVT	OTH	Flonase, Yasmin, Singulair, Flovent	No	Asthma, fibromyalgia	fever~Tdap (no brand name)~1~22.00~Patient		1						1	Chills; Injection site pain; Pain; Pyrexia	FLUX~SANOFI PASTEUR~U3179AA~UNK~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359800	10/07/2009	MI	22.0	22		F	10/07/2009	10/6 at 18:00-queasy, vomit, then 3 times of diarrhea. 10/7-couple bouts of diarrhea, sore arm, trouble lifting because sore. Trouble sleeping.									U	10/06/2009	10/06/2009	0		PUB	PVT	NAPROXEN	No	BENADRYL			1						1	Diarrhoea; Initial insomnia; Injected limb mobility decreased; Nausea; Pain; Pain in extremity; Vomiting	FLU3~SANOFI PASTEUR~U3199AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359801	10/07/2009	GA	21.0	21		F	10/06/2009	Patient hyperventilated after vaccination, pt experienced brief period of unconsciousness/unaware of surroundings. After 1 to 2 minutes patient came around and began to cry paramedics were called vital checks pt okay.									Y	10/06/2009	10/06/2009	0	Blood pressure, blood glucose	OTH	PVT	None listed					1						1	Blood glucose; Disorientation; Hyperventilation; Loss of consciousness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98437P1A~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359802	10/07/2009	MA	5.0	5		F		Hive like rash on face x 45 minutes noted by mother. Resolved with no treatment. She also had congestion, cough, conjunctivitis prior and during administration of vaccine. No fever.									Y	09/25/2009	09/28/2009	3	None	PVT	UNK		URI	Apraxia			1						1	Rash; Urticaria	FLU3~SANOFI PASTEUR~U3196AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359803	10/07/2009	WI	83.0	83		F	10/01/2009	Shot on left deltoid - right inside ear itches & red patch under right arm pit itching & spreading down the arm. Pt advised to seek urgent care -  CLARITN - HC 1% cr - ice - fluids.									U	10/01/2009	10/01/2009	0	None	OTH	PUB	Warfarin; Hyzaar; Lipitor; Metadol; Zelpisem; Diltiazem; Calcium	None	None			1						1	Erythema; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359804	10/07/2009	WI	68.0	68		F	09/27/2009	Red inflammation approximately 8cc diameter right below PNEUMOVAX injection site. No reaction at site of FLUVIRIN injection. Referred to MD, advised to use BENADRYL and ice packs by MD. Improving as of 9/26/09 with no increase and no pain.				Y					U	09/24/2009	09/25/2009	1		OTH	PVT	WARFARIN	No	Shellfish			1						1	Injection site erythema; Injection site inflammation	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848P1B~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0632Y~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0359805	10/07/2009	CO	13.0	13		F	10/03/2009	Patient stood up after 10 min post receiving vaccine shot. She started walking out of store. Felt dizzy/lightheaded. Patient threw up and was escorted by mother back to pharmacy. Patient did not lose consciousness or fall. Patient got sick again while sitting at pharmacy. EMS was notified and showed up promptly. Patient was woozy and pale, but was released after EMS evaluated her and contacted her physician.									Y	10/03/2009	10/03/2009	0	Vitals normal	OTH	UNK		Vomiting, dizzy, pale skin	None			1						1	Dizziness; Pallor; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359806	10/07/2009	NY	63.0	63		F		4 hrs-post vaccination-severe allergic reaction-massive hives, rampaging heart, chest pain, trouble breathing. Call Dr, took Benadryl, friend attended. All subsided after 3 days. Not allergic to eggs.									Y	09/18/2009	09/19/2009	1	-	OTH	UNK	Byella, Lisinopril, Zoloft, HCTZ, Pravachol, Nitrofurantoin	None	Multiple in hailant allergies, sulfa, Cipro, horse serum, psyllium, cat dander, mold.			1						1	Chest pain; Dyspnoea; Hypersensitivity; Palpitations; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~20092020inj~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359807	10/07/2009	NC	2.0	2	.6	F	10/03/2009	Redness, swelling itching at injection site within 6 hours of administration. Used MOTRIN, TYLENOL and warm compresses. Patient was seen by medical doctor 2 days after injection and was recommended to take BENADRYL.				Y					U	10/01/2009	10/01/2009	0	None	PVT	PUB	Albuterol, Flovent,  Singular, Flonage		Reactive airway disease			1						1	Injection site erythema; Injection site pruritus; Injection site swelling	FLU3~SANOFI PASTEUR~UT3174HA~3~IM~~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359808	10/07/2009	IL	29.0	29		F	09/28/2009	9/26/09 Reports temp 101 degrees with chills and dizziness at 20:00. 9/27/09 Temp 99.3 degrees. Encourage fluids at 07:30. Temp 98.2 degrees. States has feeling of a cold. Had fluids in PM and 7-8 hours sleep. 9/28/09 Reports all signs and symptoms resolved.									Y	09/26/2009	09/26/2009	0	None	OTH	OTH	ORTHO EVRA patch	None	None			1						1	Body temperature increased; Chills; Dizziness; Nasopharyngitis	FLU3~CSL LIMITED~07849111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359809	10/07/2009	IN	37.0	37		M	10/02/2009	19:30 10-1-09 Ears ringing. 20:30 10-1-09 Bloody nose, bloody stool.									U	10/01/2009	10/01/2009	0		OTH	PVT						1						1	Epistaxis; Haematochezia; Tinnitus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848P1B~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359810	10/07/2009	LA	84.0	84		F	10/01/2009	Pt reported a rash on right hand, in between thumb and right index finger. She said it itched and area appeared red, about the size of a quarter in diameter. Pt stayed in store for 20 minutes, symptoms improved and left home. I called her 30 minutes after at home, pt said she was OK.									Y	10/01/2009	10/01/2009	0		OTH	PUB	Unknown	Skin rash	Unknown			1						1	Rash erythematous; Rash pruritic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359812	10/07/2009	CO	37.0	37		F	10/02/2009	PT feeling dizzy one minute aft administration. Went out of Rx. RPH speaking to pt and she fainted lowered her to floor. Conscious after about 5 seconds asked her if she was breathing OK...ans yes sweating.									Y	10/02/2009	10/02/2009	0		OTH	PVT	EFFEXOR XR 150	NONE				1						1	Dizziness; Hyperhidrosis; Loss of consciousness; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97842P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359813	10/07/2009	WI	58.0			F	09/20/2009	Red, welt at immunization site about 2 inches in diameter. Very warm and hard to the touch.									Y		09/18/2009		None	OTH	PVT		None				1						1	Injection site erythema; Injection site induration; Injection site urticaria; Injection site warmth	FLU3~CSL LIMITED~OT249111A~1~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359814	10/07/2009	OH	60.0	60		M	09/29/2009	FIVE SEPARATE INCIDENTS OF LIP & EYELID SWELLING STARTING 36 HRS AFTER SHOT. LAST INCIDENT 9/17/2009. TODAY IS 9/29/09.									Y	09/01/2009	09/02/2009	1	None	OTH	PVT	None	None	None			1						1	Eyelid oedema; Lip swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2A~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359815	10/07/2009	TN	65.0	65		F	09/28/2009	Pt called complaining of inability to raise arm without pain. Recommended 2nd dose of ASPIRIN and follow up with PCP if no improvement 9/29/09. (Right arm).									U	09/28/2009	09/28/2009	0		OTH	PUB		Unknown	None			1						1	Injected limb mobility decreased; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98437P1A~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0627Y~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359817	10/07/2009	NE	11.0	11		F	10/07/2009	Pt developed redness, swelling, warmth, pain at site of injection- approximately 2 hrs. after injection.									Y	10/02/2009	10/02/2009	0	None	PVT	PUB	SINGULAIR 10 mg once daily; STRATTERA 60 mg once daily; CLONIDINE 0.2 mg at bedtime; CONCERTA 36 mg every am	None	Allergy to peanuts/walnuts. Has ADD, exercise-induced asthma.			1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3193AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359819	10/07/2009	OK	61.0	61		F	09/12/2009	Injection site reaction. 5 cm area of erythema, tender to palpation. Also with subjective fever/malaise. Occurred 1 day after vaccination was given. R deltoid. Treated with CLARITAN, ACETAMINOPHEN, and topical HALOG cream.									U	09/09/2009	09/10/2009	1		OTH	UNK		None	COPD, HTN, hypothyroidism			1						1	Injection site erythema; Injection site pain; Injection site reaction; Malaise; Pyrexia	FLUX~UNKNOWN MANUFACTURER~P7883P1~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0112Y~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359820	10/07/2009	DC	49.0	49		U	10/02/2009	Developed 'classic' ezcema on antecubital fossa and chest 7 days after multiple vaccines including smallpox prior to deployment. Denied history of atopic derm but has had outbreaks of other types of rashes on chest. Symptoms: Dermatitis, focal.										09/17/2009	09/25/2009	8	None	UNK	UNK	ZOCOR	None	Hyperlipidemia			1						1	Dermatitis; Eczema	ANTH~EMERGENT BIOSOLUTIONS~FAV217~UNK~UN~UN~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500691P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEP~GLAXOSMITHKLINE BIOLOGICALS~AHAVB632AA~UNK~IM~UN~HEP B (ENGERIX-B)~1|SMALL~UNKNOWN MANUFACTURER~~UNK~~UN~SMALLPOX (NO BRAND NAME)~1|TDAP~SANOFI PASTEUR~C3057AA~UNK~UN~UN~TDAP (ADACEL)~1|TYP~SANOFI PASTEUR~E00741~UNK~IM~UN~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA		Influenza
0359821	10/07/2009	OK	56.0	56		F	10/07/2009	Temperture None, Lips Swollen, itching on face and lips, then Jowl began to swell, fingers and hands started swelling and behind ears. Saw PA 10/3/09 @ 9:00 AM.  Treatment was given and started Methylprednisolone Tablets 4mg 21 count and patient started Benadryl on 10/2/09 after returned to Health Dept. clinic and stated she was going to see her Dr. ASAP or go to ER.  10/7/09 here to complete VAERS report now having hive like rash started on 10/2/09 and continues to worsen, Referred back to Dr. today ASAP.				Y					N	10/01/2009	10/02/2009	1		UNK	UNK		NO	Hypertension and Diabetes High Triglyceride and heart disease			1						1	Auricular swelling; Lip swelling; Oedema peripheral; Pruritus; Rash; Urticaria	FLU3~SANOFI PASTEUR~U3195AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359823	10/07/2009	FL	70.0	70		M	10/07/2009	Pt had severe swelling and redness of arm--not at site but from above elbow to below elbow; treated with oral antibiotics and prednisone				Y						10/02/2009	10/04/2009	2		UNK	UNK		no				1						1	Erythema; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98440P1A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0867X~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0359824	10/07/2009	NY	44.0	44		F	10/07/2009	Had chills, fever of 102. Had Tylenol.  Next day fever of 101 with malaise, body ache. Had insomnia, hyperactivity and jittery x 3 days.									Y	09/25/2009	09/25/2009	0		PUB	PVT	N/A					1						1	Chills; Feeling jittery; Insomnia; Malaise; Pain; Psychomotor hyperactivity; Pyrexia	FLU3~SANOFI PASTEUR~U3176CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359825	10/07/2009	MO	33.0	33		F	10/07/2009	Patient states that after every annual flu vaccine she has ever received, she has an asthma attack.  This was the quickest she had ever had one after a flu shot.  After Albuterol MDI, pt was fine after 10 minutes.									Y	10/06/2009	10/06/2009	0	Seen by physician and has a referral to be seen by an allergist	MIL	MIL		none	Perennial Allergies, Asthma			1						1	Asthma; Similar reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~U3212AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359826	10/07/2009	SC	24.0	24		F	10/07/2009	dizzy,pale from 11:00-12:00, then shortness of breath with increased rate of respirations, headache began which lasted rest of the day, had very weird/strange dreams that night				Y					Y	10/05/2009	10/05/2009	0	none	PVT	UNK	low hormone birth control pill, tylenol 650mg at time of vaccine	NONE	NONE			1						1	Abnormal dreams; Dizziness; Dyspnoea; Headache; Pallor; Respiratory rate increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~96032 2P~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359827	10/07/2009	FL	71.0	71		F	10/07/2009	Pt's left arm became mildly swollen and mildly warm to touch				Y						10/02/2009	10/04/2009	2		UNK	UNK		no				1						1	Oedema peripheral; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98440P1A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0867X~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0359830	10/07/2009	MO	27.0	27		F	10/07/2009	SHARP SHOOTING PAINS GOING FROM INJECTION SITE TO FINGERTIPS WHILE BEING INJECTED.  THROBBING SHARP PAIN PROGRESSIVLEY GETTING WORSE AS THE DAY WENT ON. NEXT DAY WEAKNESS IN ARM INJECTED AND SEVERE PAIN EVERY DAY. TODAY IS 10/07/2009 AND I STILL HAVE PAIN LIKE I DID THE SECOND DAY				Y					N	09/10/2009	09/10/2009	0	ON 9/21 I VISITED THE DOCTOR AND WAS TOLD  TO TAKE IBUPROFEN AND COME BACK IN 7-10 DAYS IF IT WASNT BETTER.  CALLED THE DOCTOR 9/28 AND ASKED FOR A MRI WHICH WAS REFUSED AND SAID TO COME BACK IN IN 2 MORE WEEKS IF STILL IN PAIN.	UNK	PVT	BUPRIOPRION 200 MG 2 TIMES DAILY PRENATAL VITAMIN COLACE	NONE	NONE			1						1	Injection site pain; Muscular weakness; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~66521-0112-10~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359833	10/07/2009	DE	62.0	62		F	10/07/2009	The patient recieved her pneumococcal vaccine for the first time on Friday 10/02/2009 in her right arm. She received her seasonal influenza vaccine in her left arm on the same day. She noteded redness at the injection site following administration of the pneumococcal vaccine. The redness worsed over the next few days. The site became swollen and warm to touch with some discomnfort with movement. She presented to the Emergency Department on Tuesday 10/6/2009 following a motor vehicle accident. She complained of itching around the injection site. The swelling extended to just above her elbow. There was no redness, swelling, or discomfort in her left arm (site of influenza injection)									Y	10/02/2009	10/02/2009	0		UNK	UNK						1						1	Injection site discomfort; Injection site erythema; Injection site pruritus; Injection site swelling; Injection site warmth; Pain; Road traffic accident; Injection site erythema; Injection site pain; Injection site pruritus; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~RA~PNEUMO (NO BRAND NAME)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~0632Y~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~98435P1~UNK~UN~LA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0359835	10/07/2009	NC	41.0	41		F	10/07/2009	Diagnosed with pancreatitis 10/6/09 here at Emergency Room.  No obvious other cause of the pancreatitis. 10/13/2009 received hospital records for 10/6-10/10/2009.  DC DX Acute Pancreatitis.  Patient presented with c/o's epigastric pain, chills, and  nausea. Received vaccine 10/2/2009. Admitted to ICU for monitoring,			Y	Y	Y	4			U	10/02/2009	10/03/2009	1	still working this up.  still in the hospital, ICU. Lab: CBC: wbc 17.0 high, Glucose 162 high, Lipase 2436, abnormal differential with left shift, neutrophils elevated at 14,000. Xrays: Abdominal US neg for gallstones, CT Abd/Pelvis noted acute pancreatitis involving whole pancreas. Xrays of abdomen revealed cardiomegaly.	UNK	UNK	seasonal influenza vaccine by her doctor's office Friday.  Sorry, don't have any other details regarding lot numbers, etc.  also on oxycontin, metoprolol, lisinopril, amlodipine, omeprazole.	denies	HTN, fibrillary glomerulonephropathy, chronic pain issues PMH: Chronic LBP, HTN, Fibrillary glomerulonephropathy Allergies: Ibuprofen, Toradol and Lyrica			1						1	Intensive care; Pancreatitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98437P1A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Life Threatening,Hospitalisation	Influenza
0359836	10/07/2009	WA	12.0	2	.7	M	10/07/2009	After receiving the vaccine the client fell to the floor backwards, striking his head on the ceramic tile floor.He was assessed immediately and found to be unconscious for approximately 30 seconds and was incontinent of urine. When he regained consciousness he was dizzy and nauseated, very pale and diaphoretic but oriented to person, place and time. He continued lying down with an ice pack to his head for 30 minutes after which time his father took him to the emergency room.				Y					U	09/30/2009	09/30/2009	0		PUB	PUB	None known	None known	No			1						1	Dizziness; Fall; Head injury; Hyperhidrosis; Loss of consciousness; Nausea; Pallor; Urinary incontinence	FLUX~SANOFI PASTEUR~U3210AA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0359839	10/07/2009	CA	59.0	59		F	10/07/2009	At 3:00 PM client fellt stiffness and pain in the back of her neck.  Went up the back of head and had severe pain (headache) and frontal sinus cavities, upper teeth and pressure in her ears.  At 3:30 pm she took 650 mg of aspirin without relief.  One hour later had nausea.  She layed in bed at around 8 PM she started feeling better.  No reddness, itching, or rash at injection site.  No problems breathing.  States she had had twelve prior flu vaccines with no reactions.									Y	10/06/2009	10/06/2009	0	None	UNK	PUB	Multi Vitamin, Fish Oil and Calcium D, 81 mg baby aspirin daily	None	None			1						1	Ear discomfort; Headache; Musculoskeletal stiffness; Nausea; Neck pain; No reaction on previous exposure to drug; Sinus headache; Toothache	FLU3~SANOFI PASTEUR~U3193AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359840	10/07/2009	WA	40.0	40		M	10/07/2009	Client became lightheaded and pale. He proceeded to lay down on the floor but did not hit his head or lose consciousness. No c/o nausea; alert & oriented x 3. Client stated he did not like needles and has fainted before after a shot. He was responsive at all times post initial 5-10- seconds of limited ability to verbally respond to commands. Fluids given w/o c/o nausea. Remained reclining for 30 minutes after which time he was discharged home with wife.									Y	09/30/2009	09/30/2009	0		PUB	PUB	Unknown	No	None known			1						1	Dizziness; Fear of needles; Nausea; Pallor; Syncope; Unresponsive to stimuli	FLUX~SANOFI PASTEUR~97842P2~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359841	10/07/2009	PA	75.0	75		F	10/07/2009	pt had dizziness, shaky and nausea and went to local emergency room. pt also had shallow breathing with tremors.				Y					U	10/05/2009	10/06/2009	1	pt had her vitals monitored, couldn't get iv started. had o2 at er and was given meclizine for dizziness.	PVT	UNK	pt takes multi vit, niacin, klor con,lisinopril,hctz,occuvite,asa,omega	no, patient was here for her 6 month check up/	allergies to sulfa,diflucan,lipitor,tricor,simvastatin,zetia, omacor pt has htn, asthma			1						1	Dizziness; Hypoventilation; Nausea; Oxygen saturation; Tremor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua447aa~6~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0359842	10/07/2009	TN	3.0	3		M	10/07/2009	Running nose, constant dry coughing, and low grade fever. Turned into sinus infection on 4th day. Still having runny noise and constant cough 8 days after vaccine.				Y					U	09/29/2009	10/01/2009	2		PVT	PVT	none	None	None			1						1	Cough; Pyrexia; Rhinorrhoea; Sinusitis	FLUX~UNKNOWN MANUFACTURER~~1~UN~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0359843	10/07/2009	KY	45.0	45		F	10/07/2009	Developed pain and redness as site with marked induration of subcutaneous tissues (aprox 2 x 2 cm) with redness and warmth of overlying skin.  Marked margins and observed for 3-4 hours and erythema progressing.  Started on oral bactrim and flagyl				Y					Y	09/28/2009	09/30/2009	2	NA	PUB	PUB	None	None	None			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site warmth	FLU3~CSL LIMITED~0684911A~7+~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0359844	10/07/2009	CA	75.0	75		M	10/07/2009	Got flu shot Tues. 9/29 right deltoid; Thursday right should got severe joint pain which progressed to bone and muscle aches all over.  Felt achy all over, similiar to his first episode of rheumatoid arthritis.   Lasted 24 hours.									Y	09/29/2009	10/01/2009	2	fully recovered at visit 10-7-2009	PVT	PVT	AMOXICILLIN  CAPSULES 500 MG, one PO TID ASPIRIN 81 MG, one PO qday CYCLOBENZAPRINE (flexeril)  10 MG, one by mouth three times a day as needed for muscle spasm DYAZIDE CAPSULES 25MG/37.5 MG, One tablet Daily FOLIC ACID 1 MG, one tablet thr	none	prostate cancer smoldering acute leukemia aortic aneurysm			1						1	Bone pain; Injection site pain; Myalgia; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~96031 1P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359845	10/07/2009	TX	44.0	44		F	10/07/2009	was given flu shot and within 5 minutes arm began to itch.  it became red and swollen				Y					Y	09/22/2009	09/22/2009	0		PUB	UNK		no	no			1						1	Erythema; Oedema peripheral; Pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97216 3P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359846	10/07/2009	NY	24.0	24		M	10/07/2009	Total body rash, erythematous macules, upper arms and legs, largest approx 5cm in diameter at injection site									Y	10/05/2009	10/05/2009	0	None	PUB	PVT		Not	None			1						1	Injection site erythema; Injection site macule; Rash generalised	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA4700BA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0359848	10/07/2009	NY	45.0	45		F	10/07/2009	red,pruritic,generalized  rash									U	10/02/2009	10/02/2009	0	Patient took diphenhydramine with some relief.  Patient was given a dose of diphenhydramine 50mg im on 10-6-09	UNK	UNK		none	none			1						1	Rash erythematous; Rash generalised; Rash pruritic	FLU3~CSL LIMITED~07549111A~7+~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359850	10/07/2009	OH	26.0	25		F	10/07/2009	malaise, urticaria, itching, rash									Y	09/15/2009	09/16/2009	1	none	PVT	PVT		none	none			1						1	Malaise; Pruritus; Rash; Urticaria	FLU3~CSL LIMITED~01949211A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359851	10/07/2009	OH	48.0	48		F	10/07/2009	Began w/headache and chills approx. 10 PM, no fever.  Chills continued till approx 2:30 AM; headache finally subsided approx 9:30 AM after taking 600 mg OTC ibuprofen at 8:30 AM.									Y	10/06/2009	10/06/2009	0	none	PUB	UNK	daily Microgestin, 81mg daily aspirin, 1200mg daily Vitamin D, daily multi-vitamin+iron	No	PCN allergy			1						1	Chills; Headache	FLU3~CSL LIMITED~02649211A~UNK~SC~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359852	10/07/2009	IL	45.0	44		F	10/07/2009	Swelling of face, neck, and throat.				Y					Y	09/29/2009	09/29/2009	0		PVT	UNK						1						1	Local swelling; Pharyngeal oedema; Swelling face	FLU3~CSL LIMITED~0794911A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0359853	10/07/2009	PA	76.0	76		F	10/06/2009	Information has been received from a consumer concerning his approximately 78 year old wife with lymphoma diagnosed in February 2007. The patient was underwent chemotherapy and radiation. In December 2007 she experienced a recurrent lymphoma and was prescribed oral chemotherapy from January 2008 to May 2008. In October 2008 she was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). Several weeks later, she was diagnosed with leukemia and experienced recurrence of lymphoma. On an unspecified date she was hospitalized. She received unspecified treatment which was unsuccessful. The patient died on 01-JAN-2009. The cause of death were Lymphoma and leukemia. No further information is available.  10/13/09 Hospital records and DC summary received for dates 12/11/08 to 12/23/08. DC DX: Lower back pain-resolved, fever-resolved, UTI-resolved, dental abscess, malnutrition. Presenting SX: pt c/o pain in back and both hips. Assessment: Pt found to have fever. Pt treated for current medical conditions and acute conditions and DC to rehab facility.    10/15/09 Medical records received for date of service 10/9/08.  Shingles (Zostavax) vaccine administered on 10/9/08.  Physician reports that pt. did not call office to report an adverse reaction.  10/21/09 Death Certificate DOD 1/1/2009. Myelodysplastic syndrome. Acute myelogenous leukemia. Anemia.	Y	01/01/2009		Y	Y	12			N	10/16/2008	12/11/2008	56	Unknown 10/13/09 Hospital records and DC summary received for dates 12/11/08 to 12/23/08. Diagnostics/Labs: CT abdomen and pelvisRUQ mass, bilateral pleural effusion. CXR-decreased inspiration w/ basilar effusion/atelectasis. US RUQ - cholecystitis. EKG WNL. Platelet 13(L), HGB 9.8(L), HCT 30.8(L), BUN 28(H), urine culture(+) E-coli.10/15/09 Medical records received for date of service 10/9/08.  Diagnostics and Labs:  None.	OTH	OTH	Unknown	Lymphoma	Chemotherapy; Radiotherapy 10/13/09 Hospital records and DC summary received for dates 12/11/08 to 12/23/08. PMH: Thrombocytopenia, non-Hodgkin's lymphoma, pacemaker, myelodysplastic syndrome, hyponatremia.  10/15/09 Medical records received for date of service 10/9/08.  PMH:  None.		WAES0910USA00329	1						1	Condition aggravated; Death; Leukaemia; Lymphoma	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA184AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Results in Death	Influenza
0359859	10/07/2009	MA	17.0	17		F	10/06/2009	Information has been received from a registered nurse concerning a 17 year old female with no known drug reactions/allergies and severe asthma who on 15-APR-2008 was vaccinated intramuscularly with the first dose of GARDASIL (Lot # 659964/1978U) and on 22-JAN-2009, was vaccinated intramuscularly with the second dose of GARDASIL (Lot # 661531/1311X). Concomitant therapy included ADVAIR, FLOVENT, Prednisone, Albuterol and Influenza virus vaccine (unspecified) (given on 22-JAN-2009). The registered nurse reported that the patient became pregnant after receiving the second dose of GARDASIL. She also stated the patient delivered the baby on 11-SEP-2009; however, the baby was born with hydrocephalus. The patient sought unspecified medical attention. On 01-OCT-2009, through a telephone call, the registered nurse reported that the mother and baby were being treated by the same physician. The mother was seen in the office on 22-JAN-2009 for an appointment. She was a severe asthmatic who had been on ADVAIR for years (exact therapy dates not provided) and ADVAIR was not controlling her asthmas as well as the physician would have liked. The patient was also noted to be a smoker. On 22-JAN-2009, the patient was switched to FLOVENT, Prednisone and Albuterol for asthma management. The patient was also given a flu vaccine (manufacturer not specified) and her second dose of GARDASIL. The registered nurse further noted that on that date (22-JAN-2009) the patient had a negative urine HCG test. It was estimated that the patient was actually 3 weeks, pregnant at the time of the urine pregnancy screen because she soon found out she was pregnant and her last menstrual period was estimated to have been around 02-JAN-2009. The reporter did not have the mother OB/Gyn contact information or any specific information surrounding her labor and delivery. She reported that she thought that the baby's hydrocephalus was diagnosed by ultrasound prior to his birth, but she did not have the baby's chart available at the moment to consult. She did report that the baby was 36 weeks gestation at birth on 11-SEP-2009. She did not have any more details to provide. She reported that she thinks he spent time in the hospital and thought he had a stent placed to treat the hydrocephalus. The health care professional contacted during telephone follow-up could not supply the following information: healthcare provider name and contact information for mother's OB/Gyn care or specific information about the baby. Additional information has been requested.  11/06/09 Medical records recieved for DOS range 1/22/09-10/14/09. Pt seen for asthma check 1/22/09 with vax given. ED visit for fall on ice and lower back pain mid Feb 2009. Subsequently found (+) pregnant. LMP (1/28/09). EDD 10/7/09. Return to ED 2/15/09 with abd pain and persistent back pain. UTI (+).  Several ER visits for asthma exacerbations. Prenatal consults note fetus with moderate to severe hydrocephalus and club feet seen on U/S. Amnio notes normal chromosomal, male fetus. Subsequent PCP visit for exacerbation of asthma. Poor air movement. Neb and MDI tx. Improved.  Live male infant born at 36wks. Apgars8/9 .Severe hydrocephalus.									Y	01/22/2009	01/22/2009	0	Beta-human chorionic, positive; Beta-human chorionic, 01/22/09, negative . Labs & Diags:  Fetal U/S- 19 wks, significant hydrocephalus and dilated lateral ventricles, thin cortical mantles, and dangling choroids. fetal U/S 22wks- moderate to severe ventricular dilation (brain).  MRI pelvis abnormal for fetal anomalies.	OTH	OTH	albuterol; FLOVENT; ADVAIR; prednisone	Pregnancy NOS (LMP = 1/2/2009); Asthma; Smoker	PMH: Asthma. Previous normal full-term vaginal birth in 2007. Family h/o hydrocephalus, diabetes and hypertension. Allergies: NKDA		WAES0909USA04933	1						1	Drug exposure during pregnancy; Foetal disorder; Pregnancy test positive; Premature labour	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~9000~UNK~IJ~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|HPV4~MERCK & CO. INC.~1311X~2~IM~UN~HPV (GARDASIL)~1	USA		Influenza
0359862	10/07/2009	NC	21.0			M	10/05/2009	Initial report received from a health care professional on 25 September 2009. A 21-year-old male with a concurrent illness of sinus congestion, had received an intramuscular left deltoid injection of FLUZONE No preservative 2009-2010, lot number U3171AA on 24 September 2009 and one day later, he developed shortness of breath, sweating and a feeling of heaviness in his left arm and leg. The patient had been sick in bed fro two days with sinus congestion prior to vaccination. The patient denied any pre-existing medical conditions and he had not been taking any concomitant medications. At the time of the report, the patient's recovery status was unknown. Documents held by sender: None.				Y					U	09/24/2009	09/25/2009	1	Not reported	OTH	UNK		The patient had sinus congestion at the time of vaccination and had been sick in bed for two days with sinus congestion prior to vaccination.			200904102	1						1	Dyspnoea; Hyperhidrosis; Sensation of heaviness	FLU3~SANOFI PASTEUR~U3171A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359863	10/07/2009	AZ	41.0	41		F	10/05/2009	Initial report was received from a consumer on 25 September 2009, who is also the patient. A 41-year-old female patient with no concurrent illness or past medical history who had been taking TOPAMAX concomitantly, had received an injection (route not reported) of FLUZONE SV 2009-2010, lot number U3205CA on 24 September 2009, and 4 hours later, she complained of difficulty breathing, itchy throat, mouth and tongue, lips burning, mucous discharge from both eyes, eyes reddened, muscle aches/ pain, dizziness, nausea and feeling feverish. The patient self medicated with ADVIL and 2-3 doses of BENADRYL until she went to bed. The next day, all symptoms were resolved except for a feeling of tingling skin all over. The patient had not been evaluated by their health care provider and at the time of the report, they had not recovered. Documents held by sender: None.				Y					N	09/24/2009			Not reported	UNK	UNK	TOPAMAX		The patient had no known allergies and no pre-existing medical conditions. The patient had been taking TOPAMAX concomitantly at the time of vaccination.		200904109	1						1	Burning sensation; Dizziness; Dyspnoea; Eye discharge; Feeling hot; Myalgia; Nausea; Ocular hyperaemia; Oral pruritus; Paraesthesia; Throat irritation	FLU3~SANOFI PASTEUR~U3205C~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359865	10/07/2009	NY				U	10/02/2009	Initial report received from a health care professional on 24 September 2009. This patient is part of a cluster of 10 unidentified patients. The other nine patients experienced non-serious events and have been captured in case number 2009-04085. An unidentified patient had received an intramuscular left deltoid injection of FLUZONE SV 2009-2010, lot number U3194AA on 22 September 2009 and within 24 to 48 hours (also reported as 23 September 2009), they developed a swollen throat which required an emergency room visit. Additional symptoms may have included a scratchy throat, headache, general malaise, ear pain, GI symptoms and a red itchy injection site. According to the reporter, the patient had not recovered from the event. No additional information was provided. The reporter for this case is the same as for case 2009-04085. Documents held by sender: None.				Y					N	09/22/2009	09/23/2009	1	Not reported	PUB	OTH			The patient had not received any other vaccines within four weeks prior to receiving FLUZONE SZ 2009-2010.		200904084	1						1	Ear pain; Gastrointestinal disorder; Headache; Injection site erythema; Injection site pruritus; Malaise; Pharyngeal oedema; Throat irritation	FLU3~SANOFI PASTEUR~U3194A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359866	10/07/2009	IL	67.0	67		U	10/02/2009	Initial case received from a pharmacist on 25 September 2009. A 67-year-old patient, with no reported history, presented to the hospital with acute coronary and possible autoimmune hemolytic anemia six days after receiving FLUZONE SV (lot not reported) on 12 September 2009. The patient presented to the emergency department on 18 September 2009 with acute coronary, and at the time of the report was being assessed for autoimmune hemolytic anemia. The reporter did not provide any additional information.					Y	0			N	09/12/2009	09/18/2009	6		UNK	UNK			Not reported.		200904101	1						1	Acute coronary syndrome	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0359873	10/07/2009	OR				F	10/02/2009	Initial report received on 24 September 2009 from a health care professional. This case pertains to one of a cluster of three patients involving misuse. The same reporter provided information regarding three patients who had been exposed to an investigational product involving a clinical trial sponsored by Sanofi Pasteur (reference number FIM07), but who were not enrolled in the study. All three patients had received investigational product instead of a marketed influenza vaccine. Information regarding the other two patients is reported in cases 2009-04114 and 2009-04113. A pregnant female patient, had received a dose of investigational product INFLUENZA VIRUS VACC USP TRIVAL A&B HIGH DOSE, SUBVIRION-U on an unspecified date. No other information was reported. It was not reported whether the patient has experienced any adverse events after being vaccinated. Documents held by sender: None.				Y					U				Not reported	UNK	UNK			Not reported		200904157	1						1	Drug exposure during pregnancy; Wrong drug administered	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359874	10/07/2009	OR	25.0	25		F	10/02/2009	Initial report received on 24 September 2009 from a health care professional. This case pertains to one of a cluster of three patients involving misuse. The same reporter provided information regarding three patients who had been exposed to an investigational product involving a clinical trial sponsored by Sanofi Pasteur (reference number FIM07), but who were not enrolled in the study. All three patient's received investigational product instead of marketed influenza vaccine. Information regarding the other two patients is reported in cases 2009-04114 and 2009-04157. A healthy 25-year-old pregnant female , had received a first intramuscular right deltoid injection of investigational product INFLUENZA VIRUS VACC USP TRIVAL A&B HIGH DOSE, SUBVIRION-U, (lot number UD12307) on 23 September 2009. Obstetrical history included one prior pregnancy that resulted in one live birth with no congenital anomalies. The date of the patient's last menstrual period was on 09 January 2009, and her expected date of delivery is on 16 October 2009. Prenatal tests include Serology test performed in July 2009 (reported as 2006), and an ultrasound on 28 May 2009 that were normal. The patient had not experienced any adverse events. Documents held by sender: None				Y					U	09/23/2009			Prenatal tests performed in July 2009 (reported as 2006) and Ultrasound on 28 May 2009 were normal.	PVT	PVT			Healthy 25-year-old who had obstetrical history of one prior pregnancy that resulted in one live birth with no congenital anomalies.		200904113	1						1	Drug exposure during pregnancy; Laboratory test normal; Ultrasound scan normal; Wrong drug administered	FLU3~SANOFI PASTEUR~UD12307~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359884	10/07/2009	IL	24.0	24		F	10/07/2009	right arm swollen, red and warm to touch				Y					Y	09/29/2009	10/01/2009	2		PVT	UNK						1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~CSL LIMITED~04794911A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0359885	10/07/2009	AZ	65.0	65		M	10/07/2009	swelling, soreness, hard to raise arm, redness all the way wrapped around from deltoid muscle to front and bottom of biceps, cramping of bicep muscle									Y	09/29/2009	09/29/2009	0		UNK	PVT	diclofenac 75 bid, valtrex 500 qd, nexium 40 qd, MVI qd	no	seasonal/environmental allergies, spinal stenosis, asthma			1						1	Erythema; Mobility decreased; Muscle spasms; Oedema peripheral; Pain in extremity	FLUX~SANOFI PASTEUR~05849111a~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~05044~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359886	10/07/2009	IL	77.0	77		F	10/07/2009	Heartburn feeling stomach and throat									Y	09/29/2009	09/29/2009	0		PVT	UNK			Increased blood pressure; cardiac history			1						1	Dyspepsia	FLU3~CSL LIMITED~07949111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359887	10/07/2009	IL	41.0	41		F	10/07/2009	Itching face, arms and head; generalized hives				Y					Y	09/29/2009	09/29/2009	0		PVT	UNK						1						1	Pruritus; Urticaria	FLU3~CSL LIMITED~0794911A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0359889	10/07/2009	DC	23.0	23		F	10/07/2009	night sweats, enlarged supraclavicular lymph node									N	10/01/2009	10/03/2009	2		PVT	PVT		none	none	golf sized lymph nodes~Influenza (Seasonal) (no brand name)~~22.00~Patient		1						1	Lymphadenopathy; Night sweats	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960305P~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359890	10/07/2009	NM	53.0	53		F	10/07/2009	Sore arm, fever, achy, headache, fatigue, ravenous appetite									Y	10/06/2009	10/06/2009	0		PVT	PVT	omnaris, claritin, benadryl, avonex	No	Multiple Sclerosis, Migraine, hayfever			1						1	Fatigue; Headache; Increased appetite; Pain; Pain in extremity; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359895	10/07/2009	OK	57.0	57		F	10/07/2009	Large red swollen area from shoulder to slightly above elbow. On 10/06/2009 area became more swollen and itching with hives. Took 50 mg of Benadryl. it is still swollen and red and somewhat itchy.										10/05/2009	10/05/2009	0		PVT	UNK		None	allergy to chicken feathers and chicken	large red swollen area~DTP (no brand name)~~52.50~Patient		1						1	Erythema; Oedema peripheral; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~u3192aa~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359896	10/07/2009	TX	29.0	29		F	10/07/2009	SWELLING OF INJECTION SITE, FOLLOWED BY ARM, FOLLOWED BY FACE/NECK									U	10/07/2009	10/07/2009	0		UNK	PVT		NO	ALLERGY TO MILK AND MILK PRODUCTS			1						1	Injection site swelling; Local swelling; Oedema peripheral; Swelling face	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98441P1A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359897	10/07/2009	SD	5.0	5		M	10/07/2009	The flu vaccine (regular flu not H1N1) was given in patient's left arm.  When giving him a bath the next evening I noticed it was red, hot, and swollen.  The redness extended from his shoulder to his elbow.  He had a fever of 101 degrees.  We called our family doctor and he didn't not think we needed to seek treatment at that time.  We gave patient Ibuprofen and put cold compresses on his arm.  We drew an outline around the redness and by the next day the redness had increased.  We went to see Dr.  He said the redness and swelling was a reaction to the flu vaacine and not an infection.  He said it was a severe reaction and advised us not to get patient any more flu vaccinations.  On 10-1-09 we took patient to see an allergist.  He also agreed it was a reaction and not an infection.  He said it was a pretty severe local reaction.  He was puzzled by the delayed onset of the reaction and the fact that patient had had several flu vaccines before with no ill effects.  He did scratch tests to test for allergies to eggs and the flu vaccine.  They were negative.  He also did a patch test which contained the flu vaccine and was left on patient's back for 4 days.  No reaction occured.  Patient was on Zyrtec all during this time.									Y	09/28/2009	09/29/2009	1		UNK	UNK		none	seasonal allergies treated with over the counter Zyrtec			1						1	Allergy test negative; Hypersensitivity; Injection site erythema; Injection site swelling; Injection site warmth; Pyrexia	FLUX~SANOFI PASTEUR~U3177BA~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359898	10/07/2009	CA	43.0	43		F	10/07/2009	Soreness at injection site 2 area's of induration one 2cm by 2cm one 4cm by 4cm, pain with pressure, 2-3/10. Pain with arm use overhead. No warmth,no lymphadenopathy, no drainage.									U	09/28/2009	09/28/2009	0	none	UNK	UNK		no	no			1						1	Injection site induration; Injection site pain; Pain	FLU3~CSL LIMITED~01449211A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359899	10/07/2009	TX	27.0	27		M	10/07/2009	Facial Swelling, Head and Feet Itching, Air Way not compromised, Tretment of Benadryl 50 mg PO, and EMS Activated				Y					Y	10/07/2009	10/07/2009	0		MIL	MIL		UNK	UNK			1						1	Pruritus; Swelling face	ANTH~EMERGENT BIOSOLUTIONS~FAV217~1~IM~LA~ANTHRAX (BIOTHRAX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500729P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TYP~SANOFI PASTEUR~B0762~1~IM~RA~TYPHOID VI POLYSACCHARIDE (TYPHIM VI)~1	USA	Emergency room visit	Influenza
0359901	10/07/2009	VA	8.0	8		M	10/07/2009	Low grade Fever, throat hurting,upset stomach, croupe, cough, congestion				Y					U	09/29/2009	10/02/2009	3	Flu Test, Strep Test, Blood Work	PVT	PVT		No				1						1	Abdominal discomfort; Blood test; Cough; Influenza serology; Oropharyngeal pain; Pyrexia; Streptococcal identification test; Upper respiratory tract congestion	FLUN3~MEDIMMUNE VACCINES, INC.~~2~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0359902	10/07/2009	NC	66.0	66		M	10/07/2009	inflamed right upper arm from shoulder to elbow; overactive bladder,kidney; frequent urination; flu-like pain in lower back and right shoulder--general sluggishness and irritability									Y	09/30/2009	10/02/2009	2	none	UNK	UNK	none	none	allergic to shell fish and bee/wasp stings			1						1	Back pain; Hypertonic bladder; Inflammation; Irritability; Musculoskeletal pain; Pollakiuria; Renal disorder; Sluggishness	FLUX~UNKNOWN MANUFACTURER~~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0823Y~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359903	10/07/2009	VA	25.0	25		F	10/07/2009	Sore throat, nasal congestions, followed by fever, body aches, chills, and headache.					Y	8		Y	N	08/30/2009	09/03/2009	4	can be provided upon request.  Several MRIs CT scans, blood, urine, tests.	UNK	UNK	Depo provera every 90 days.  Have been on medication for 10 years.	Three 9/3 days later came down with flu like symptoms.  Nine days later 9/12 began fainting and going into violent convolsions.  Two weeks later legs began to fatigue and neck began to shake periodically. On 9/23 lost the ability to walk (walk like I have MS cannot keep my gait straight and entire body shakes when walking). On 9/24 lost the ability to talk (stuttering) neck pulls and strains when talking.  Symptoms have continued, I was diagnosed with Dystonia caused by the Fluzone 2009-10 Multivial SA vaccine.  Symptoms have not ceased but worsened.	No pre-existing conditions.  Healthy at the time of vaccine.			1						1	Chills; Headache; Nasal congestion; Oropharyngeal pain; Pain; Pyrexia; Urine analysis	FLU3~SANOFI PASTEUR~U3189AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation,Disabling	Influenza
0359905	10/07/2009	MN	55.0	55		F	10/07/2009	Redness on l-arm, around injection site and upper shoulder; accompanied by mild pain and chills.									U	10/06/2009	10/06/2009	0	None	MIL	OTH		None	None			1						1	Chills; Erythema; Injection site erythema; Pain	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359906	10/07/2009	TX	69.0	69		F	10/07/2009	redness, warmth of inner upper right arm. warmth at injection site.Entire right upper arm (shoulder to elbow) painfull. Diagnosed as cellulitis.Clindomycin prescribed.				Y						10/05/2009	10/06/2009	1		UNK	PUB	allergies &/or reactions to: Bactrim and Fosamax.	none	pulmonary hypertension, atrial septal defect, polymyalgia rheumatica, osteoporosis			1						1	Cellulitis; Erythema; Injection site warmth; Pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~IM~RA~PNEUMO (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0359917	10/07/2009	GA	61.0	61		F	10/07/2009	Soreness, swelling, redness, pain. Started in L deltoid and moved to medial aspect. Pt had PNEUMOVAX 5 yrs ago.									N	10/05/2009	10/05/2009	0		OTH	UNK		No	Hypertension			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA284AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~0632Y~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359918	10/07/2009	TX	29.0	29		U		After receiving FLUMIST patient reported chest tightness. When assessed patient was holding chest and breathing difficulty teary eyes, red skin feeling dizzy slow speech mild allergic reaction. One shot of EPINEPHRINE administered. Patient had a relief from the respiratory distress. Dispatched ambulance transferred patient for further evaluation. Later, released soldier with diagnosis of mild allergic reaction.				Y					Y	10/06/2009	10/06/2009	0		MIL	MIL		Was not ill prior to vaccination	No other pre-existing condition			1						1	Chest discomfort; Dizziness; Dyspnoea; Erythema; Hypersensitivity; Lacrimation increased; Respiratory distress; Speech disorder	FLUN3~MEDIMMUNE VACCINES, INC.~500729P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0359919	10/07/2009	NJ	36.0	36		F	10/07/2009	Fainted, nausea, could not open eyes, could not move legs, hallucination (thought she was on the phone with husband). Follow up with patient's husband-she is doing OK.				Y					U	10/07/2009	10/07/2009	0		OTH	OTH	Birth control					1						1	Eyelid disorder; Hallucination; Monoplegia; Nausea; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98432P1~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359920	10/07/2009	WA	49.0	49		F	10/07/2009	Shot given approx 0900, then about 2 PM became short of breath,  felt like someone sitting on my chest.  Then about 4 PM became bright red.									Y	10/06/2009	10/06/2009	0		PVT	PVT	No	No	Allergic to cats & dogs, rare asthma.			1						1	Chest discomfort; Dyspnoea; Erythema	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFL1LA456BA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0359922	10/07/2009	CA	18.0	18		F	10/07/2009	5 min. after receiving immunization, patient had chills, patient started to feel nausea. On the way to bathroom, she felt dizziness & fainted for 5 sec. in bathroom.									Y	09/18/2009	09/18/2009	0	None	PVT	PVT		None	Mild Scoliosis			1						1	Chills; Dizziness; Nausea; Syncope	FLU3~SANOFI PASTEUR~U3205CA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C3250AA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0359923	10/07/2009	NY	77.0	77		M	10/02/2009	Rash near injection site - hives, itching & along shoulder too, & inside of arm.  Red, itchy hives.									U	09/16/2009	10/01/2009	15		OTH	OTH	Unknown	None	Unknown			1						1	Erythema; Injection site rash; Pruritus; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359924	10/07/2009	KS	16.0	16		F	10/07/2009	9-28-09 Patient received vaccines. 10-03-09 Patient miscarried/spontaneous abortion at ER. She was 6 weeks pregnant.				Y					Y	09/28/2009	10/03/2009	5		PUB	PUB		Pregnant				1						1	Abortion spontaneous	FLU3~SANOFI PASTEUR~U3174EA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1445X~3~UN~LA~HEP B (RECOMBIVAX HB)~1|HPV4~MERCK & CO. INC.~0087Y~2~UN~RA~HPV (GARDASIL)~1|IPV~SANOFI PASTEUR~B0476~2~UN~RA~POLIO VIRUS, INACT. (IPOL)~1|VARCEL~MERCK & CO. INC.~0810Y~2~UN~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0359926	10/07/2009	MO	16.0	16		M	10/07/2009	Bell Palsy to right side of face starting 10/4/09. No treatment. Improving spontaneously. 12/2/09 Medical records received for date 10/7/09. DX: Bell's palsy. Presenting SX: c/o cannot close rt. eye or smile w/ rt side of mouth x3 days w/ gradual improvement. Pt received flu shot x2wks ago. Assessment: rt eyelid not able to close completely, rt side mouth not able to abduct completely.										09/26/2009	10/04/2009	8		UNK	PVT	CONCERTA; RITALIN	None	Grass pollen, dog dander, cat dander			1						1	Facial palsy	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359927	10/07/2009	VA	41.0	41		F	10/07/2009	Redness, swelling, pain at injection site. Patient advised to take ALEVE and use cold compresses for comfort, right arm.									Y	10/06/2009	10/06/2009	0		PVT	PVT		Tinea Corpis	Sarcoidosis			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U3207AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1287X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359928	10/07/2009	IL	50.0	50		F	10/07/2009	Warm and bulging around injection site within 2 1/2 hours later. No trouble breathing, itching none. Gave EPIPEN shot at 18:50 by 19:30 pain gone.									N	10/07/2009	10/07/2009	0		OTH	PUB			None			1						1	Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97850P1~7+~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1315Y~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359929	10/07/2009	CA	1.04	1	.0	M	10/07/2009	Inconsolable screaming all night x 2 nights per report of parents.									Y	09/25/2009	09/25/2009	0		PVT	UNK	None	None	None			1						1	Crying; Screaming	FLU3~SANOFI PASTEUR~UT3178CA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0764Y~1~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|PNC~PFIZER\WYETH~D92436~4~IM~LL~PNEUMO (PREVNAR)~1	USA		Influenza
0359930	10/07/2009	OH	22.0	22		M	10/07/2009	Patient passed out immediately after the vaccination. He appeared to have a seizure for 1-2 minutes. His mother referred to it as a vasovagal response.				Y					Y	10/07/2009	10/07/2009	0		OTH	PVT						1						1	Convulsion; Loss of consciousness; Presyncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848P1C~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359931	10/07/2009	VA	31.0	31		F	10/07/2009	Immediate redness at the site of injection. Patient complained of a burning sensation running down her arm immediately after the shot. Gave her 25mg BENADRYL & observed 30 minutes with no worsening. As of 6pm today she has had no worsening of symptoms but c/o hot flashes.									U	10/07/2009	10/07/2009	0		OTH	PVT	None reported to this pharmacy	None	None			1						1	Burning sensation; Hot flush; Immediate post-injection reaction; Injection site erythema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960323P~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359932	10/07/2009	FL	66.0	66		M	10/07/2009	Red rash spreading from area where shot was administered. Diarrhea several days.									U	09/29/2009	10/02/2009	3		UNK	PUB			Diabetic			1						1	Diarrhoea; Injection site erythema; Injection site rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97844P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359933	10/07/2009	MO	56.0	56		F	10/07/2009	Erythema induration at injection site, 7x4 cm within 4 hours decreased erythema today. No warmth or induration patient has no allergy to contacts and solution.									Y	10/02/2009	10/02/2009	0		PVT	PVT		No	No			1						1	Injection site erythema; Injection site induration	FLU3~SANOFI PASTEUR~C3210AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359934	10/07/2009	TX	66.0	66		F	10/02/2009	Itching and redness to L deltoid. Itching/redness and swelling to R deltoid. 10/2/09 at 11:31-phone check to pt and she reports doing better and no more redness to sites.									Y	09/29/2009	09/29/2009	0	None	PVT	PVT	CARDIZEM LA 240 mg; ADVAIR DISKUS 250/150; LISINOPRIL 20 mg; FLUCONAZOLE; METFORMIN; ACIPHEX 20 mg;  NOVOLOG MIX 70/30; LIPITOR 20 mg	None	Asthma, hypertension, AO, DM, hypercholesterolemia			1						1	Injection site erythema; Injection site pruritus; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97845P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0867X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0359935	10/07/2009	CA	60.0			F	10/07/2009	Within 24 hrs status post FLUVIRIN vaccine, employee developed severe nausea/vomiting, stomach cramping and fatigue causing her to call in sick to work.				Y					U					OTH	OTH		None	None known			1						1	Abdominal pain upper; Fatigue; Nausea; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97847P2~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359936	10/07/2009	CA	47.0	47		F	09/24/2009	None Stated Arm sore after shot but later came back and said not due to shot but tendonitis concidence. Patienct came in for third time to say saw another MD and said arm was due to the shot she got 11/19/090				Y					U	09/24/2009	09/25/2009	1		OTH	PVT		None	None	Sore Arm~Influenza (Seasonal) (Fluvirin)~1~47.00~Patient		1						1	Pain in extremity; Tendonitis; Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~92840P1~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359938	10/07/2009	NV	59.0	59		F	10/07/2009	Vertigo (positional, worse when on side or back). Nausea started 24 hours after vaccine. Continuing for 6 days. Patient went to urgent care recovered antivert on day 4. Slightly relieved but still present slowly improving.				Y						10/01/2009	10/02/2009	1		PUB	UNK	Cymbalta, Climara Pro, Cosopt, Fosamax, Xalatan, Xanax	None	None			1						1	Nausea; Vertigo positional	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359939	10/07/2009	CA	48.0	48		F	10/07/2009	Patient describes feeling like she has a charlie horse, does not get worse, she said this and she probably held arm funny during vaccination.									U	10/07/2009	10/07/2009	0	None	OTH	PVT	None current known	None	Unknown			1						1	Muscle spasms	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359941	10/07/2009	MA	46.0	46		F	10/07/2009	1 hr after receiving vaccine pt c/o feeling dizzy then in the next hr started wheezing and developed hives on upper body. Also had stomach pain. Pt gave self BENADRYL and used ALBUTEROL inhaler every 2-3 hours. She was feeling fine by 00:00. I gave FLUZONE at 14:30.									Y	10/01/2009	10/01/2009	0	None	OTH	PVT	ALBUTEROL mdi	None	Allergy to Pen VK, develops hives, itchy; asthma			1						1	Abdominal pain upper; Dizziness; Urticaria; Wheezing; Dyspnoea; Similar reaction on previous exposure to drug; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U3207AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U3207A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0359942	10/07/2009	WI	47.0	47		F	10/07/2009	Bilateral eye redness and swelling X 2 hours after vaccine.  Now resolved.  Per pt report.									Y	10/06/2009	10/06/2009	0		PVT	PVT	ELAVIL; ADVAIR; ALBUTEROL.	Sore throat.	Contrast dye; HTN; Asthma; Anxiety; Goiter.	Same~Influenza (Seasonal) (no brand name)~UN~0.00~Patient		1						1	Eye swelling; Ocular hyperaemia	FLU3~CSL LIMITED~07849111A~3~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359943	10/07/2009	WA	13.0	13		M	10/07/2009	Per mom report-had temp and hallucinated within 12 hours of receiving imm.									Y	09/25/2009	09/25/2009	0	None	PVT	PVT	None	None				1						1	Body temperature increased; Hallucination	FLU3~SANOFI PASTEUR~U3198AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U3017AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0359944	10/07/2009	NY	57.0	57		F	10/07/2009	Red itchy area developed 24 hrs after vaccination. Report received 10/2. Patient described previously diagnosed allergy to thimerosal-did not inform vaccinator of this. Also did not report latex allergy at time of vaccination.									Y	09/28/2009	09/29/2009	1	None	PUB	PUB		None	Thimerosal			1						1	Erythema; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA257AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0359951	10/07/2009	CA	77.0	77		M	10/07/2009	10/3 - started with mental changes 24 hours after influenza vaccine. Dx with encephalitis.	Y	11/24/2009			Y	51			U	10/02/2009	10/03/2009	1	See report	PVT	OTH						1						1	Encephalitis; Mental status changes	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97844P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0359955	10/07/2009	NE	40.0	40		F	10/06/2009	Eyes became red, itchy & swollen. Developed cough, wheeze & difficulty breathing, throat tightening. Took BENADRYL 50 mg PO. Then chills, achiness, nausea & vomiting. Fell asleep feeling better by 2 am in morning. Fell asleep feeling better by 2 AM in morning. 9/30/09 - developed rash/hives on chest & abdomen.			Y						Y	09/28/2009	09/28/2009	0	None	OTH	PVT	lisinopril; MICROGESTIN	none	current ovarian cyst under treatment			1						1	Chills; Cough; Dyspnoea; Eye pruritus; Eye swelling; Nausea; Ocular hyperaemia; Pain; Rash; Throat tightness; Urticaria; Vomiting; Wheezing	FLU3~SANOFI PASTEUR~U3176FA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0359962	10/07/2009	TX	11.0	11		M	10/07/2009	Arm is sore and red around vaccine site. Symptoms started after the morning after the vaccine was administered.									U	10/06/2009	10/07/2009	1		PVT	OTH	VFC	None	NKA			1						1	Injection site erythema; Injection site pain	FLUN3~MEDIMMUNE VACCINES, INC.~500683P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U3017AA~1~UN~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0359963	10/07/2009	NM	15.0	15		F	10/07/2009	Approximately 15 minutes after vaccine had red and swollen area to right cheek 60mm x 50mm. Administered 50 mg Benadryl Mt 1600 10-6-09. At 10-7-09 0800 area approximately size of fifty cent piece.									Y	10/06/2009	10/06/2009	0	N/A	PUB	PUB	NA	None	None			1						1	Erythema; Swelling face	FLUN3~MEDIMMUNE VACCINES, INC.~500697P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0359970	10/07/2009	CT	8.0			F	10/07/2009	Cough/fever x 6 days-RUL pneumona (clinical).				Y					N					PVT	PVT		None	ECZEMA			1						1	Cough; Lobar pneumonia; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500711P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0359972	10/07/2009	TX	46.0	46		F	09/19/2009	Red, itchy, watery, blood shot eyes, runny nose, cough, slight rubbing to upper L posterior lobe, scratchy throat. Pt trying to clear throat, headache with pressure behind eyes, stated she felt slightly confused, flushing to face, redness to ears, stated she felt hot and sweaty lasting 15-20 min. then was freezing x 30 min. Felt like she needed to have BM-this lasted from start to finish x 5 hours-with symptoms diminishing as time passed. Pt used ALBUTEROL inhaler x 1 but denied using other medical treatment even though she was told she was having allergic reaction.									Y	09/19/2009	09/19/2009	0		OTH	PVT	PULMICORT; ALBUTEROL	None	Asthma			1						1	Confusional state; Cough; Defaecation urgency; Erythema; Eye pruritus; Feeling of body temperature change; Flushing; Headache; Hyperhidrosis; Hypersensitivity; Lacrimation increased; Ocular hyperaemia; Rhinorrhoea; Throat irritation	FLU3~CSL LIMITED~07849111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359973	10/07/2009	TX	22.0	22		F	09/29/2009	Approx. 20 min after vaccine, employee stated she felt slightly confused with leg weakness, vital signs 145/60, 102. Employee took 15 min break, returned stated she felt better but now with a headache, rated a 4 on (1-10 pain scale). Employee took ibuprofen, 400 mg. Stated headache lasted x 12 hours but never increased above a 4 pain level. Denies taking anymore meds or seeking medical attention.									Y	09/29/2009	09/29/2009	0	None	OTH	PVT	None	No	None			1						1	Confusional state; Headache; Muscular weakness	FLU3~CSL LIMITED~07849111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0359974	10/07/2009	NJ	52.0	52		M	10/07/2009	Rhabdomyolysis --> Renal Failure --> Dialysis. CPK >500,000. Fever 99.5 to 102. AST 2918.10/23/2009 hospital records for 10/2-10/9/2009 with Neuro and GI consults. Patient presented with c/o's rt hand numbness/tingling, poor grip strength and speech impairment. Patient found to have elevated LDH, LFT's and CPK, UA + for UTI. Tx: Dialysis, IV ABX . DC Dx Renal failure, Rhabdomyolysis ? etiology					Y	7				09/28/2009	10/01/2009	3	None Labs: CBC: Hct 29.6, Hgb 10.3 both Low, BMP: Na 123 Low, BUN 43 High, LDH 21,000, ALT 557, AST 2918, creatinine 6.4, CPK 500,000 all High,  LYME titer, ANA, HIV, West Nile, Hepatitis panel all negative, Urine cytology negative, complement studies WNL, UA + for UTI, ESR 101 High, Total Bili 13, Uric acid 11.3, Troponin 0.25 all High, Rapid influenza test, Influenza AB panel negative,  Anti JO-1 AB, Trichinella AB,, PPD  Dx studies/Xrays: MRI Head abnormal, noted a subcentimeter rt frontal lobe T2 flare, MRI LS-spine abnormal noting muld bilateral foraminal stenosis with disc protrusion, Renal US WNL, Ct head WNL, CXR abnormal noting blunting lt costophrenic angle, effusion, and fullness lt hilum, EKG normal	OTH	OTH			Diabetes type II; Leg abscess drained 9/2007; Prior R femur fracture  PMH: DM Type II, Chronic Back Pain Allergies: NKDA			1						1	Aspartate aminotransferase increased; Blood creatine phosphokinase increased; Dialysis; Pyrexia; Renal failure; Rhabdomyolysis	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA260AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation	Influenza
0359979	10/07/2009	PR	36.0	36		M		See attached forms: DD Form 2766C Vaccine Administration Record. Standard Form 600 Health Record Chronological; Record of Medical Care.									U	09/19/1999				MIL	MIL						1						1	Arthralgia; Disturbance in attention; Dyskinesia; Hypoaesthesia; Memory impairment; Oedema peripheral	ANTH~EMERGENT BIOSOLUTIONS~FAV044~1~UN~UN~ANTHRAX (BIOTHRAX)~1|FLU3~CONNAUGHT LABORATORIES~H998235~1~IJ~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|MEN~CONNAUGHT LABORATORIES~D954950~1~UN~UN~MENINGOCOCCAL (MENOMUNE)~1	USA		Influenza
0359757	10/08/2009	NY	42.0	42		F	10/08/2009	NAUSEA,VOMITING,BACK PAIN,TEMP-100.3F,MUSCLE ACHES. HIVES THAT EVENING ZOFRAN FOR NAUSEA				Y					Y	10/02/2009	10/02/2009	0		PUB	PVT		NONE	HYPOTHYROIDISM,HTN ALLERGIES-CODEINE,COMPAZINE,MORPHINE,CONTRAST DYE,WHEAT,YEAST			1						2	Joint swelling; Lip swelling; Muscular weakness; Nausea; Pyrexia; Urticaria; Vomiting; Back pain; Body temperature increased; Myalgia; Nausea; Urticaria; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~96033 4P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~96033 4P~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2	USA	Emergency room visit	Influenza
0359975	10/08/2009	VA	78.0	78		M	10/07/2009	Symptoms started at 3:00 pm yesterday felt weak, had trouble breathing, dizziness, headache.									N	10/06/2009	10/06/2009	0		PUB	PUB	Levothroid 100 mg	None	None			1						1	Asthenia; Dizziness; Dyspnoea; Headache	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359987	10/08/2009	TX	49.0	49		M	10/08/2009	Received FLUARIX vaccine 09/21/09. Presented to ER with painful vesicular eruptions on left upper extremity (vesicles with surrounding erythema). Date of ER visit 10/04/09. T 99.4. Treatment-cover lesions as needed for drainage, follow up with primary care physician 10/05/09.				Y					U	09/21/2009	10/02/2009	11	CBC, CMP both WNL	PVT	PVT		None				1						1	Full blood count; Metabolic function test; Pain in extremity; Rash vesicular; Skin lesion	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA474BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0359988	10/08/2009	LA	4.0	4		M	10/08/2009	Lg erythematous plaque with induration distal Left deltoid, lat triceps area, is tender - 15cm x 8cm.				Y					Y	10/06/2009	10/07/2009	1	None	PVT	PVT						1						1	Injection site erythema; Injection site induration; Injection site pain; Skin plaque	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B137AA~UNK~IM~LA~DTAP + IPV (KINRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500709P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MMR~MERCK & CO. INC.~07734~UNK~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~1073Y~UNK~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0359989	10/08/2009	FL	0.53	0	.5	M	10/08/2009	Facial swelling, drooling, hives.				Y					Y	10/06/2009	10/08/2009	2	Allergic reaction.	PVT	PUB	None on date vaccine given.	None	None			1						1	Drooling; Hypersensitivity; Swelling face; Urticaria	FLU3~SANOFI PASTEUR~U3260AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0359990	10/08/2009	OH	14.0	14		F	10/07/2009	Complained of swollen lymph nodes on R side of neck, stiff neck and soreness under R armpit.									Y	10/05/2009	10/06/2009	1		PUB	PVT		None	NKDA			1						1	Axillary pain; Lymphadenopathy; Musculoskeletal stiffness	FLU3~SANOFI PASTEUR~U3207AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0359991	10/08/2009	MO	43.0	43		F	10/07/2009	Employee presented to employer seasonal flu vaccination clinic. Requested/inquired if vaccine was preservative free confirmed vaccine preservative free. Received vaccination 10/02/09 at 0900, around 10:00 AM experienced sore throat - scratchy feeling - slight tightness. Took BENADRYL 50 mg P.O. with relief of symptom.									Y	10/02/2009	10/02/2009	0		PUB	PVT	FLONASE; HCTZ		Blood pressure; Allergy seasonal; CT contrast media; Thimerosal			1						1	Oropharyngeal pain; Throat irritation; Throat tightness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960351P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359992	10/08/2009	IL	38.0	38		M	10/07/2009	Pt presented for seasonal flu vaccination clinic. Received flu vaccine about 0845. At 10:00 am noticed redden rash covering both arms. Presented to ED. Given BENADRYL PO with relief of rash.				Y					Y	10/02/2009	10/02/2009	0	None	PUB	PVT	PREDNISONE in last 60 days	None	Allergy- Seasonal			1						1	Erythema; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960351P~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0359993	10/08/2009	MA	59.0	59		M	10/07/2009	Pt states had flu shot 5 days ago. Next day developing facial numbness and (R) side of arms weakness and facial droop. Went to ER 10/5/09 (pt thought it was a reaction to shot and would subside). Medical Records and Discharge Summary received 10/13/09. Dates of Service 10/5/09 to 10/8/09.  Dx:  Acute Cerebrovascular Accident, Hypertension, Diabetes, Smoker. Presenting Sx:  Pt. presented with right-sided weakness, facial drooping and slurred speech for a few days prior to admission, and 5 days after having a flu shot. As symptoms progressed, it became difficult for pt. to walk on his R leg.  The patient medicated himself at home with 162 mg of aspirin the day prior to admission and his speech began to improve and the weakness to subside.  The patient was started on full dose aspirin in the ED. Since admission the patients right sided weakness progressively improved, the slurred speech completely resolved. The patient did not reveal any weakness on his right side for 18 hours prior to discharge.  The patient was ambulating without difficulty.   Consultation with a neurologist with  the advice to control HTN, and smoking cessation. Patient to continue on aspirin therapy and antihypertensives.  Pt. to f/u with PCP in 3 days.					Y					09/29/2009	09/30/2009	1	DX of CVA, Labs and Diagnostics:  BUN 6 (L), glucose 114 (H), RBC's 4.59 (L), Hgb 13.9 (L), Hct 41.8 (L), RDW 15.7 (H), HDL Cholesterol 38 (L), EKG-normal, Head CT w/o contrast-Normal, MRA of Neck and Head-no evidence of vascular abnormalities, Echocardiogram showed normal EF with no evidence of segmental wall abnormality.  Trans-Esophageal Echocardiogram:  normal study with no evidence of cardiogenic emboli.	PUB	PUB		F/u visit of DM; HTN	Allergies = ASA,PMH:  Diabetes mellitus for which he does not take medication, hypertension, hypercholesterolemia, chronic smoker, right-sided groin hernia. Possible allergy to aspirin-chest pain (can take baby aspirin).			1						1	Cerebrovascular accident; Facial palsy; Hypoaesthesia facial; Muscular weakness	FLU3~SANOFI PASTEUR~U3208AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0359994	10/08/2009	PA	48.0	48		F	10/07/2009	Patient received flu vaccine at apx 11:15 a.m. 10-2-09 in Left deltoid. Sore that evening. 10-3-09 arm sore and lt neck soar/stiff. 10-4-09 stiffness and ache lt neck, lt arm, left side of back to waist. Couldn't turn head to left until 10-7-09. Off work for 3 days.									Y	10/02/2009	10/03/2009	1	None	MIL	MIL	none	None	None			1						1	Injection site pain; Musculoskeletal stiffness; Neck pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~9843P1A~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0359995	10/08/2009	WI	10.0	10		F	10/07/2009	Pt was seen on 10/5/09 after receiving FLUMIST and varicella vaccine on 10/2/09. She c/o B both arms and both leg weakness. She describes a feeling of a weight on them. The arm symptoms improved through the day but leg symptoms persisted and weakness. Was not stable on exam. Lower extremity reflexes were normal.				Y					U	10/02/2009	10/05/2009	3	No testing performed.	PVT	UNK	None	None	PCN allergy			1						1	Gait disturbance; Muscular weakness; Reflex test normal; Sensation of heaviness	FLUN3~MEDIMMUNE VACCINES, INC.~500725P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~9971Y~UNK~UN~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0359996	10/08/2009	OH	1.92	1	1	M	10/08/2009	Cranky and severe diarrhea for 24 hours.									Y	09/22/2009	09/22/2009	0		PUB	PVT		None				1						1	Diarrhoea; Irritability	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~LL~HEP A (NO BRAND NAME)~1|MMR~UNKNOWN MANUFACTURER~~UNK~~LL~MEASLES + MUMPS + RUBELLA (NO BRAND NAME)~1	USA		Influenza
0359997	10/08/2009	OH	9.0	9		F	10/08/2009	Felt sick and had severe diarrhea for 24 hours.									Y	10/01/2009	10/01/2009	0		UNK	UNK	Advair	none	Asthma			1						1	Diarrhoea; Malaise	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~~RA~HEP A (NO BRAND NAME)~1|VARCEL~UNKNOWN MANUFACTURER~~UNK~~RA~VARICELLA (NO BRAND NAME)~1	USA		Influenza
0359998	10/08/2009	OH	34.0	34		F	10/08/2009	Itchy, small, spotty, bumpy, rash on back.									U	10/06/2009	10/07/2009	1		PVT	PUB	None	none	Pregnant			1						1	Rash; Rash papular; Rash pruritic	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0359999	10/08/2009	NY	33.0	33		F	10/08/2009	Redness and discharge both eyes associated with body aches x 2 days.									Y	10/05/2009	10/05/2009	0	none	PUB	PVT	Nasonex	No	None			1						1	Eye discharge; Ocular hyperaemia; Pain	FLU3~CSL LIMITED~01449211A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360000	10/08/2009	NY	11.0	11		M	10/08/2009	Patient devloped a nose bleed after vaccine									Y	10/08/2009	10/08/2009	0	none	PVT	PUB		no	none			1						1	Epistaxis	FLUN3~MEDIMMUNE VACCINES, INC.~500705p~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~u3010aa~1~IM~~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~ac52b046aa~1~IM~~TDAP (BOOSTRIX)~1	USA		Influenza
0360001	10/08/2009	WI	30.0	30		M	10/08/2009	SYMPTOMS CONSISTENT WITH ALLERGIC REACTION TO INCLUDE HIVES, WHEEZING AND TROUBLE BREATHING.									Y	09/16/2009	09/16/2009	0		PVT	PVT		NO	NO			1						1	Dyspnoea; Hypersensitivity; Urticaria; Wheezing; Obstructive airways disorder; Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|FLU3~SANOFI PASTEUR~U3193AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0360002	10/08/2009	WI	47.0	47		F	10/08/2009	Got severe dizziness to the point of falling down & not being able to walk, vomiting, and severe headache									Y	10/01/2009	10/01/2009	0		PUB	PVT	none	None	None			1						1	Abasia; Dizziness; Fall; Headache; Vomiting	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflla281aa~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0360008	10/08/2009	MI	12.0	12		M	10/08/2009	Local site reaction less than 10mm redness, sore and under arm soreness. 3rd day onset of hives. Benedryl given along with steroids.				Y						10/05/2009	10/06/2009	1		PVT	PVT		None	None			1						1	Injection site erythema; Injection site pain; Local reaction; Pain in extremity; Urticaria	FLU3~SANOFI PASTEUR~U3216AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360009	10/08/2009	VA	54.0	54		M	10/08/2009	Reports shortness of breath while eating dinner out.  Had to come outside and leaned against his car thinking he may pass out.  No loss of consciousness.  Episode lasted a couple of minutes.  He then experienced diarrhea and stomach ache on 10/04/2009 followed by flushing in his face and hives over his torso, thighs, neck and arms.  He took Benadryl on 10/06/2009 and symptoms began to resolve.									Y	09/29/2009	09/30/2009	1	n/a	UNK	PVT		n/a	n/a			1						1	Abdominal pain upper; Diarrhoea; Dyspnoea; Flushing; Urticaria	FLU3~SANOFI PASTEUR~U3213AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360011	10/08/2009	CA	26.0	26		F	10/08/2009	Arm pain that resolved and then recurred after three weeks post vaccination									Y	09/24/2009	09/24/2009	0		PUB	PUB						1						1	Pain in extremity	FLU3~CSL LIMITED~~1~~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360012	10/08/2009	NC	9.0	9		F	10/08/2009	Chills, fever of 101 F										10/07/2009	10/07/2009	0		UNK	UNK		Mild sore throat, no fever or other symptoms	Reflux of the kidneys, but mild and no longer in active treatment for it.			1						1	Chills; Pyrexia	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500754P~1~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA		Influenza
0360013	10/08/2009	WI	47.0	47		F	10/08/2009	Fatigue, achiness, horrible headache and horrible cough, rough throat, no fever.									Y	09/29/2009	09/30/2009	1		UNK	UNK	None	NO	No			1						1	Cough; Fatigue; Headache; Pain; Throat irritation	FLUN3~MEDIMMUNE VACCINES, INC.~500681P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360014	10/08/2009	MO	49.0	49		F	10/08/2009	Started Swollen and Sore, By 4pm hurting into muscle and felt like into the bone. Pain from injection site to finger tips, left arm. Pain continued all night.				Y					U	10/07/2009	10/07/2009	0		PUB	UNK		none				1						1	Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360015	10/08/2009	PA	27.0	27		M	10/08/2009	Wake up and had alot of bumps on my right arm, back, and face. I went to the ER and I had a all reaction to something in the flu shot that I had got on 10/07/2009 and the doctor at the hospital prescripted Benadryl for me to start taking.				Y						10/07/2009	10/08/2009	1		UNK	UNK		No	No			1						1	Hypersensitivity; Rash papular	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360016	10/08/2009	WV	1.94	1	.9	M	10/08/2009	Broke out in rash of red spots all over the body. I could not feel the bumps though.									Y	10/07/2009	10/07/2009	0		UNK	UNK		no	no			1						1	Rash erythematous; Rash generalised	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360019	10/08/2009	MA	59.0	0	.7	M	10/08/2009	Woke with cold sweats, felt warm, severe headache, pain in shoulders, arms, legs, stiff neck. Fine flat red rash on torso, thighs, stomach, back. Tingling, numbness in legs.				Y					U	10/03/2009	10/04/2009	1	Blood work done; results unknown.	PUB	PUB	Unknown	NO	No			1						1	Blood test; Cold sweat; Feeling hot; Headache; Hypoaesthesia; Musculoskeletal pain; Musculoskeletal stiffness; Pain in extremity; Paraesthesia; Rash	FLU3~SANOFI PASTEUR~U3188AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360021	10/08/2009	VA	56.0	56		F	10/08/2009	On 10/5 around 1130AM I received my annual flu shot in my left arm and my prescription for Vitamin D 50000 UNIT Oral Capsule to Take 1 Capsule Weekly for my deficiency. The only reaction I seemed to have from the flu shot was a slight headache that afternoon and evening (no medication taken). Around 2pm I ate lunch (mixed greens/vegs, grilled chicken). Around 9pm I took one capsule of the VitD, with calcium lactate and magnesium oxide tablets (normal daily supplements), while eating a snack mix of baked fruit and nuts & yogurt pieces. Within one hour my throat swelled up--swollen lymph gland on left side, under jaw. Painful to eat/swallow/touch. Still swollen and tender 2 days later.  I've never had a reaction to the yearly flu shots I get; nor did I react to the same VitD regimen I had previously in May 2008. I don't have any allergies; have never had a swollen gland before.  My doctor prescribed Methylprednisolone 4MG DOSTRI for 6 days.  I began the medication on 10/07/2009 and have experienced significant reduction in the swelling and tenderness.									U	10/05/2009	10/05/2009	0		PVT	UNK	Vitamin D 50,000 units, 1 weekly capsule; supplements: calcium lactate, magnesium oxide, multivitamin	None	Postive Antinuclear Antibody test (Raynauds); Vitamin D deficiency			1						1	Dysphagia; Headache; Lymphadenopathy; Odynophagia; Pharyngeal oedema; Tenderness	FLUX~UNKNOWN MANUFACTURER~~1~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360022	10/08/2009	DC	38.0	38		M	10/08/2009	Hives all over body along with swelling of lips and throat tightness. Pt took Benedryl and Advil, Benedryl helped.				Y					U	10/06/2009	10/06/2009	0	None	UNK	PVT	Atripla--last took the night before receiving the 2 vaccines (10/5/09), had been taking it already for >1 month (started on 8/31/09).	None	1. HIV 2. Depression 3. Allergy to Bactrim & Latex			1						1	Lip swelling; Throat tightness; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~aflua447ca~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1162X~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0360023	10/08/2009	PA	1.51	1	.5	M	10/02/2009	18 month old boy received FLUZONE -Lot U3199AA-, from multidose vial with Thimerosal, also Polio Vaccine -Lot- D0120-2-, and Hep A Vaccines -Lot VAQTA 1604X-. 2 days subsequent to the vaccine he experiences an episode of paralysis in the upper body and a gazing stare. He had opened eyes but would not respond. This episode last approximately 5 minutes. He came out of this absence seizure like state very slowly. It took about 20 minutes before he had his normal energy level. EMTs came to the house as the pediatrician had us call 911. We took him to hospital. He was given a neurological examination, and vitals, and EKG. No EEG was done. He was cleared with a Neurologic Consult and D/C to home.   11/09/09 Medical records received for DOS 10/20. Neurology office note. FInal DX; FIrst Seizure. Child fell to ground. limp, eyes deviated laterally(suggestive of focal onset), unresponsive. Pale, discolered around lips. Aroused at 5 min. On hour until completely conscious.  S/p 18 mos vaccines and flu vaccine. Neuro PE WNL. Recommended MRI.   12/9/09 ER recs received for date 10/1/09. DX: seizure, viral syndrome Presenting c/o: parent states pt was playing then became limp x20min, eyes were gazing. Parent states pt had rhinorrhea, cough x2-3days, 1 vomit x10 days ago.				Y					U	09/29/2009	10/01/2009	2	Labs & Diags: EEG WNL.   12/9/09 ER recs received for date 10/1/09 Diag/labs: EKG(-)	UNK	UNK			PMH: 38 weeks gestation, heart murmur benign, resolved by 6 mos. Walked at 13 mos. Vocab age appropriate. Eczema, seasonal allergies.  Allergies: NKDA			1						1	Electrocardiogram; Gaze palsy; Neurological examination; Paralysis; Petit mal epilepsy; Staring; Unresponsive to stimuli	FLU3~SANOFI PASTEUR~U3199AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~1604X~UNK~UN~UN~HEP A (VAQTA)~1|IPV~SANOFI PASTEUR~D01202~UNK~UN~UN~POLIO VIRUS, INACT. (IPOL)~1	USA	Emergency room visit	Influenza
0360025	10/08/2009	IL	5.0	5		F	10/08/2009	Noticed swelling, pain, redness at site of KINRIX. Area approx 1 1/2 diameter. Continued to swell and turn more red. Returned to Clinic on 10/8/09 site approx very swollen, c/o sore throat, body aches.									U	10/06/2009	10/07/2009	1	Seen at Clinic. They felt it was an abscess and are tx with Abx (sulfa);Family has hx of MRSA + (not his child)	PUB	PUB		None	AUGMENTIN	Slight swelling~ ()~UN~1.00~Patient		1						1	Injection site abscess; Injection site erythema; Injection site pain; Injection site swelling; Oropharyngeal pain; Pain	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B115AA~1~UN~LL~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~U3179BA~2~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0483Y~2~UN~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0798Y~2~UN~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0360026	10/08/2009	WI	63.0	63		M	10/05/2009	Edema of Lower Lip.									Y	09/30/2009	10/01/2009	1		MIL	MIL	Metformin, Gemfibrozil, HCTZ 50/Triam 75, Lisinopril		Macular Degeneration Cataracts, Hypertension, DMII, Hyperglyceridemia, Dementia			1						1	Lip oedema	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98438P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360027	10/08/2009	NY	42.0	42		M	10/07/2009	Fever, chills, generalized body malaise, blurry vision, facial break outs (blemishes), localized soft tissue pain, induration and swelling at injection site. Admitted to hospital for observation. Pt recovered. 10/16/09 Hospital records received for dates 9/24/09 to 10/3/09. Pt seen in ER 9/24 DX: Contact Dermatitis. Presenting SX: vision changes, HA, sweating, itching after receiving Flu vaccine same day. Assessment: some burry vision noted, facial rash on forehead. tx and dc. Pt seen in ER on 9/25/09 with c/o achiness, chills, fever, decrease weight. DX: Acute URI. Assessment: WNL except erythematous rash on forehead. tx and dc. ER visits on 9/26/09 Presenting  SX: c/o right limb pain, swelling, painful lump on right pectoral area, right shoulder pain. Pt was admitted to hospital for observation and r/o testing. DX: Acute URI, myositis, asthma. Assessment: (+)right deltoid swelling, (+)induration. Pt treated and stable at time of dc. Diagnostics/Labs: CXR(-), right shoulder xray(-), EKG(-), UA (+)blood, WBC 13.6(H), PTT 24.9(L), platelets 142(L), neutrophils% 69.2(H), lymphocytes% 18.1(L),  WR CRP 27.36(H) PMH: smoker, appendectomy at age 14, dental implants at age 37. ICD9 codes: 995.3, 692.9, 465.8, 728.0, 493.90				Y	Y	2			Y	09/24/2009	09/24/2009	0	10/16/09 Hospital records received for dates 9/24/09 to 10/3/09. Diagnostics/Labs: CXR(-), right shoulder xray(-), EKG(-), UA (+)blood, WBC 13.6(H), PTT 24.9(L), platelets 142(L), neutrophils% 69.2(H), lymphocytes% 18.1(L),  WR CRP 27.36(H)	PUB	UNK			10/16/09 Hospital records received for dates 9/24/09 to 10/3/09. PMH: smoker, appendectomy at age 14, dental implants at age 37.			1						1	Chills; Injection site induration; Injection site pain; Injection site swelling; Malaise; Pyrexia; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA449BA~UNK~IJ~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0360029	10/08/2009	CA	55.0	55		F	10/06/2009	Severe pain and redness in a site of injection (significantly more severe & least expected).									Y	09/25/2009	09/26/2009	1		PVT	PVT		No	No			1						1	Injection site erythema; Injection site pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98432P1~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0024Y~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360031	10/08/2009	MD	43.0	43		F	10/08/2009	Eyes itchy, blurry, completely red around 4 PM patient got into shower, throat started to tighten and had difficulty breathing, hives on front of legs, wheezing, coughing, patient went to ER and was given epinephrine, SOLU-MEDROL 60 mg, BENADRYL 50 mg.				Y					Y	10/07/2009	10/07/2009	0		OTH	PVT	PENTASA; ALTACE; SYNTHROID	None	Crohns			1						1	Cough; Dyspnoea; Eye pruritus; Ocular hyperaemia; Throat tightness; Urticaria; Vision blurred; Wheezing	FLU3~SANOFI PASTEUR~U3192AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360034	10/08/2009	FL	12.0	12		F	10/02/2009	Mother reported that patient started to develop small itchy bumps on legs within hours of receiving vaccine. Rash increased. Never had wheezy or difficulty breathing. Went to ER in the early evening_given Benadryl and Prednisone. Pt was determined by ER physician 464247, to be having possible allergic reaction to FLUMIST. Mother reported improvement of symptoms within hours of being in the ER. PT was evaluated in the doctor's office 10-2-09 and rash had completely resolved.				Y					Y	09/29/2009	09/29/2009	0		PVT	PUB		Seborrhea				1						1	Rash pruritic	FLUN3~MEDIMMUNE VACCINES, INC.~5006879~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0360037	10/08/2009	OH	2.0	2	.3	M	10/05/2009	10/3/09 Evening-had fever per mom's call on 10/5/09. 10/4/09 Mom noticed son's arm was warm to the touch, hard, swollen, reddened, and painful to the touch. 10/5/09 Arm continues to be swollen, red, and hard. PHN discussed E E S Chorj; PHN advised mom to have child seen at stat  care or pcp per Dr.									N	10/03/2009	10/03/2009	0	N/A	PUB	PUB		N/A	N/A			1						1	Injection site erythema; Injection site induration; Injection site pain; Injection site swelling; Injection site warmth; Pyrexia; Injection site erythema; Injection site induration; Injection site pain; Injection site swelling; Injection site warmth; Pyrexia	FLU3~SANOFI PASTEUR~UT3253HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~UT3253HA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA		Influenza
0360040	10/08/2009	NJ	47.0			U		C/O heat & swelling of entire upper arm, radiating to axilla, chills & fever, This began 3-4 hours after injection of PNEUMOVA X, lasting 3 days.									Y					OTH	PUB		None	Asthma			1						1	Chills; Oedema peripheral; Pyrexia; Skin warm	FLU3~SANOFI PASTEUR~U3207AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1296X~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1|TD~UNKNOWN MANUFACTURER~AO19A~UNK~IM~UN~TETANUS DIPHTHERIA (NO BRAND NAME)~1	USA		Influenza
0360041	10/08/2009	TX	46.0	46		F	10/08/2009	Patient stated that on vaccination date the site was warm and a welp started.  Patient took Zyrtec and it did not progress.  Patient called on 10/8/09 to say that she has a bruise the size of a quarter at the injection site and that a new welp was developing a few inches below the injection site.  Pt states that it is not getting any worse and that she had already taken Benadryl and no action was necessary but that she wanted to let us know.									U	10/06/2009	10/06/2009	0		UNK	PVT	Pt has had flu shots every year for at least 10 years with no previous reaction	None	None Listed			1						1	Injection site haematoma; Injection site urticaria; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960316P~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360043	10/08/2009	NY	45.0	45		F	10/08/2009	Redness to chest and left upper arm and face. Saw spots when felt lightheaded. 12/1/2009 ED record for 10/6/2009, patient with c/o's dizziness, numbness lt arm and red rash over face and neck. Rx'd benadryl BP was elevated, to f/up with PCP  Dx flu-like syndrome					Y	1			Y	10/06/2009	10/06/2009	0	n/a Labs/Dx studies none	UNK	UNK		NONE	NONE PMH: None Allergies: PCN			1						1	Dizziness; Erythema; Injection site erythema; Visual impairment	FLU3~CSL LIMITED~08449111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Hospitalisation	Influenza
0360044	10/08/2009	FL	52.0	52		F	10/08/2009	SWELLING, ITCHING, WARMTH AND REDDNESS AT SITE										10/06/2009	10/07/2009	1		PUB	PVT		NO	NO			1						1	Injection site erythema; Injection site pruritus; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P1~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360046	10/08/2009	CO	61.0	61		F	10/08/2009	Hands and feet became very reddened; burning and itching; took Benadryl 25 mg every 4-5 hours for several days, until symptoms relieved									Y	09/22/2009	09/23/2009	1	NA	MIL	MIL	Unknown	No	No			1						1	Burning sensation; Erythema; Pruritus	FLU3~CSL LIMITED~07649111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360067	10/08/2009	TX	4.0	4		F	10/08/2009	upper left arm swollen 50% bigger, redness over half the upper arm, tender, painful, shoulder with injection site swollen to twice normal size									U	10/05/2009	10/05/2009	0		MIL	MIL	Claritin	None	Allergies to animals and pollen			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~UNK~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360068	10/08/2009	MI	58.0	58		M	10/08/2009	Headache for three days, different than usual headaches Body aches Temperature 98.8									Y	09/17/2009	09/18/2009	1	None	PUB	UNK		None	None			1						1	Body temperature increased; Headache; Pain	FLU3~SANOFI PASTEUR~U3197AB~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360069	10/08/2009	CA	62.0	62		M	10/08/2009	Painful belly cramps and severe diarrhea.  Took imodium.  It is now around 12:30 p.m.  I still have some cramps and still have loose stools, though not as bad or as frequent as early this morning.									U	10/07/2009	10/08/2009	1	no	UNK	PVT		No	Allergic to penicillin.  Taking simvastatin for cholesterol control.			1						1	Abdominal pain upper; Diarrhoea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~NDC: 66521-0112~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360071	10/08/2009	MN	5.0	5		F	10/08/2009	Fever, Sore Throat, Leg Pain				Y					U	10/06/2009	10/07/2009	1	Unknow, Patient was seen at the ER, not this clinic	PUB	UNK		No Known	IGA Immunodeficiency Selective (279.01) Asthma, Mild Intermittent, Well Controlled (493.90AX)			1						1	Oropharyngeal pain; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~u3259fa~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0614x~1~IM~LL~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0360077	10/08/2009	AZ	18.0	18		M	10/08/2009	Employee experienced body aches, head ache, sore throat, and fever starting two days after vaccine was administered. Symptoms lasted for 6 days.									Y	09/29/2009	10/01/2009	2	None	UNK	UNK	None	None	None			1						1	Headache; Oropharyngeal pain; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA468CA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0360079	10/08/2009	AZ	64.0	64		F	10/08/2009	Starting 5-6 days after administration of vaccine, employee experienced low grade fever, sore throat, joint/muscle aches, burning eyes, heart flutter/palpitation. Symptoms lasted for 2 days then resolved.									Y	09/28/2009	10/05/2009	7	None	UNK	UNK	Prilosec OTC, Levothyroxine, Oxybutinine, Xanax PRN, ASA low dose, multivitamin, and cranberry pills.	None	Hypothyroidism, Anxiety, Depression, Superventricular tachycardia, alergic to cipro and bactrim.			1						1	Arthralgia; Cardiac flutter; Eye irritation; Myalgia; Oropharyngeal pain; Palpitations; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA468CA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0360080	10/08/2009	MN	14.0	13		F	10/08/2009	Red, puffy, purple around injection site. abx given.				Y					Y	10/02/2009	10/04/2009	2		PVT	PVT		NA	Asthma			1						1	Injection site discolouration; Injection site reaction; Injection site swelling	FLU3~SANOFI PASTEUR~U3201AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0469Y~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0360082	10/08/2009	WV	62.0	62		M	10/08/2009	PATIENT SAYS HE IS EXPERIENCING A RASH, THAT IS NOT LOCALIZED TO THE INJECTION SITE. I INSTRUCTED HIM TO USE BENADRYL TO HELP TREAT THE SYMPTOMS IN CASE IT WERE AN ALLER									U	10/06/2009	10/08/2009	2		UNK	PVT	PATIENT HAS RECEIVED VACCINE IN PREVIOUS YEARS AND HAD NO REACTION. I AM NOT SURE THIS IS TRULY A REACTION TO THE VACCINE, BUT THOUGHT IT SHOULD BE REPORTED JUST IN CASE.	No.	None reported.			1						1	Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360084	10/08/2009	GA	17.0	17		F	10/08/2009	local reaction									Y	10/06/2009	10/08/2009	2		PVT	PVT		none	n/a			1						1	Local reaction	FLU3~SANOFI PASTEUR~U3174FA~UNK~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B047BA~UNK~IM~RL~TDAP (BOOSTRIX)~1	USA		Influenza
0360087	10/08/2009	DE	39.0	39		M	10/08/2009	Shot administered at 3rd Party location on 10/2 at 6 PM.  Adverse affect noticed 10/5 in evening with irritation. Minor  swelling under tongue around noon on 10/6.  Extreme swelling of elbow on same arm as shot on 10/7.  Wnet to Dr on 10/8 around 2 pm - swollen elbow, no pain in joint, inflamation of tissues, hot to touch - not itchy, soreness in shoulder joint of same arm now.  Prescribed Augmentin, Mortin and ice.  If swelling persists on 10/9 Dr will consider draining elbow.				Y					U	10/02/2009	10/05/2009	3	Bloodwork, including gout test, blood count etc.  Waiting for test return.	UNK	PVT	None; Flu Vaccine = ICD-9 Code - V04.81 CPT Code: 90658	None	None			1						1	Blood test; Joint swelling; Musculoskeletal pain; Skin irritation; Swollen tongue	FLUX~UNKNOWN MANUFACTURER~ICD-9: V04.81~1~IJ~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360088	10/08/2009	MO	5.0	5		F	10/08/2009	My daughter started to complain of chills, and later at home her temp was 102.8.  She had the flu vaccine at 4PM.									U	10/07/2009	10/07/2009	0	None yet.	PVT	PVT		None, just picked her up from Kindergarten.	None			1						1	Body temperature increased; Chills	FLUX~UNKNOWN MANUFACTURER~~3~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360090	10/08/2009	FL	59.0	59		F	10/08/2009	Starting 9/24 symptoms included aching and malaise and feeling of being sick, with scratchy throat.  9/25/09 I started itching on head and groin area.  9/26/09 Hives startd on head, groin, hands, elbows, knees, thighs feet. Palms and soles of feet were affected as well.  Benedryl 75mg. did not help, nor did periactin or Zyrtec. Dr. prescribed hydroxyz pam 25 mg, which did not help, bud 75 mg. was able to control symptoms. MD prescribed Prednisone in dosage amounts and gave steroid shot as well.   I am on last day of prednisone and still have reactive skin to the touch and take the hydroxyz pam in order to sleep because I still have itching.  The itching was very intense and my right hand swelled to double its size.  Today is the 8th of October and I am not completely over the reaction.									Y	09/23/2009	09/24/2009	1		PUB	UNK		Fybromyalgia	Fybromyalgia Shingles prevention dosing yeast infection			1						1	Malaise; Oedema peripheral; Pain; Pruritus; Throat irritation; Urticaria	FLU3~SANOFI PASTEUR~U3213AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360092	10/08/2009	CA	6.0	6		F	10/08/2009	New onset seizure, taken to hospital. Given lorazepam and loaded with dilantin. Non-responsive, intubated. Transferred to another hospital.				Y	Y	4			U	10/07/2009	10/07/2009	0	Normal head CT. EEG pending.	UNK	UNK	Isoniazid 300mg Qday	none	Latent Tuberculosis Infection, on isoniazid treatment			1						1	Computerised tomogram normal; Convulsion; Electroencephalogram; Endotracheal intubation; Scan brain; Unresponsive to stimuli	FLUX~SANOFI PASTEUR~U3203AA~1~IM~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0360093	10/08/2009	TX	56.0	56		F	10/08/2009	localized area of warmth, tenderness, and pain									Y	09/21/2009	09/22/2009	1		PVT	PVT		none	none			1						1	Injection site pain; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98441P1A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360094	10/08/2009	TX	28.0	28		F	10/08/2009	localized area of warmth, tenderness, pain, and itching									U	10/07/2009	10/08/2009	1		PVT	PVT		none	none			1						1	Injection site pain; Injection site pruritus; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98441P1A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360096	10/08/2009	OK	2.0	2	.0	M	10/08/2009	parents report that child started throwing up about 30 min after flu mist was given times 3; also had some watery yellow diarrhea.									Y	10/08/2009	10/08/2009	0	none	PUB	PUB		Mom reported had some diarrhea before flu mist was given.	none			1						1	Diarrhoea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500721P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360097	10/08/2009	WA	39.0	39		F	10/08/2009	WOKE THIS MORNING ARM WAS SORE AND SWOLLEN AND WARM TO THE TOUCH AND A RED SPOT A SIZE OF A FIFTY CENT PIECE.									U	10/07/2009	10/08/2009	1	NONE	PUB	PUB		none	none			1						1	Erythema; Oedema peripheral; Pain in extremity; Skin warm	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA265AA~5~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0360098	10/08/2009	TX	64.0	64		F	10/08/2009	localized area of redness, warmth, and pain									Y	10/02/2009	10/03/2009	1		PVT	PVT		none	hypertension			1						1	Injection site erythema; Injection site pain; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98441P1A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360099	10/08/2009	TX	50.0	50		F	10/08/2009	About 15 minutes after injection, began having numbness, warm sensation, and itching starting at my left jaw and going into distinct areas of my left side of my face. Was unable to fully wrinkle my forehead and it felt very strange, could not close my left eye completely, could not purse my lips or drink from a straw. My ear and jaw kept itching deeply. It began to resolve within about 2 hours, but I still will have some residual weakness when I am fatigued. I did not see a doctor that day because it was Saturday PM and I did not think it was an emergency. (seemed to be facial nerve irritation-precursor of Bell's palsy?)									Y	10/03/2009	10/03/2009	0	none-Saturday pm - doctor not available	UNK	UNK		no	asthma, seasonal allergies, allergies to dander, mold, etc., migraine, fibromyalgia, hypertension			1						1	Asthenia; Facial nerve disorder; Facial paresis; Fatigue; Feeling hot; Hypoaesthesia; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA257AA~UNK~IJ~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0360100	10/08/2009	CA	56.0	58		F	10/08/2009	Complained about being dizzy, said her tongue felt swollen and her face was tingling.				Y					Y	10/06/2009	10/06/2009	0	CXR and cardiac enzymes were done;  She was given Benedryl 50 mg IM and observed; she was dischaged post feeling better and symptoms resolved.	PVT	PVT		She did not state any when asked.	None that she stated, when questioned about allergies she said no, not even to eggs.			1						1	Cardiac enzymes; Chest X-ray; Dizziness; Paraesthesia; Swollen tongue	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA 458BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0360101	10/08/2009	CA	59.0	59		F	10/08/2009	Large painful induration and fever.  Fever caused altered mental status either directly due to fever or indirectly by causing lowering of seizure threshhold and pt had complex partial seizure. 10/28/2009 hospital records from 9/26-9/29/2009. Patient with sx of chills, fever and altered mental status. Tx: IV ABX, med to decrease ammonia levels. DC DX's: AMS, PNA, vaccine reaction, Loss of consciousness, not likely due to seizure					Y	3			Y	09/24/2009	09/25/2009	1	Labs: CBC, WBC 10.6 high, UA WNL, Hepatitis panel negative, TSH 18 high, CSF normal Dx studies: EEG abnormal noting mild diffuse disturbance of cerebral function, non-specific as to cause.  MRI Brain increased # of punctate white matter foci, non-specific ? Infectious process vs Vasculitis, CT Head normal.	UNK	UNK		no	seizure disorder, hypothyroidism, chronic sinusitis, COPD PMH: Hypothyroidism, seizure d/o, COPD			1						1	Complex partial seizures; Condition aggravated; Induration; Mental status changes; Pain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua448aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0024y~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0360102	10/08/2009	LA	8.0	8		M	10/08/2009	sudden onset of sneezing, coughing, runny nose (clear discharge) with excoriation of nasal folds from constant use of facial tissues to cover sneezes.									U	10/07/2009	10/08/2009	1		UNK	PUB		no	none			1						1	Cough; Excoriation; Rhinorrhoea; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360103	10/08/2009	WA	7.0	7		F	10/08/2009	child appeared with facial flushing and a fine rash on her face, hands, back and abdomen.				Y					Y	10/08/2009	10/08/2009	0		UNK	PUB		no	NKA			1						1	Flushing; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~500697P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0360104	10/08/2009	IL	46.0	46		F	10/08/2009	Patient noticed a swelling to the left side of her neck which became very tender and sore. Client saw PCP when swelling did not decrease and pain worsened. The physician completed a CT scan of the neck and determined that the employee has enlarged lymph glands in her neck. The PCP also ran a blood test that showed positive for a history of epstein barre. The client's PCP determined that the employee sustained an autoimmune reaction from the Influenza vaccination									Y	09/23/2009	09/25/2009	2	Positive findings on the CT scan of the neck (Enlarged Lymph nodes) Positive result on blood work to epstein barre.	PVT	PVT		None	Well controlled Asthma			1						1	Computerised tomogram abnormal; Epstein-Barr virus test positive; Local swelling; Lymph node pain; Lymphadenopathy	FLU3~GLAXOSMITHKLINE BIOLOGICALS~476AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0360105	10/08/2009	CO	8.0	8		M	10/08/2009	Headache, nausea, heavy chest. Ibuprofen, Tylenol.									U	10/07/2009	10/08/2009	1	none	UNK	UNK	none	none	none			1						1	Chest discomfort; Headache; Nausea	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360106	10/08/2009	FL	42.0	42		F	10/08/2009	Soreness in muscle, remained sore on a daily basis with it being the most painful first thing in the morning and at night.  3 weeks after shoot it still hurts if not more than before.  Hurts to lift arm and other reaching type movements.										09/17/2009	09/17/2009	0		UNK	UNK		no	asthma, allergic to pollen, pet dander, grass, dust			1						1	Mobility decreased; Myalgia; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~1~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360107	10/08/2009	ID	44.0	44		F	10/08/2009	injection site started to swell at about 4:30 PM patient watched by 5:30 PM the left side of her neck, upper mouth and eye were swollen. she called her MD between 5:30 pm and 6:00 pm. he told her to take benadryl.. She took 1/2 tablet then repeated 30 minutes later. The swelling was reduce by 11:00 pm.  As of 10/8/2009 the patient reported that her arm, throat and mouth were still sore but that the swelling was gone.									Y	10/06/2009	10/06/2009	0		UNK	PVT		none	penicillins and benzodiazepine			1						1	Eye swelling; Injection site pain; Injection site swelling; Local swelling; Oedema mouth; Oral pain; Oropharyngeal pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97842p2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360109	10/08/2009	MA	42.0	42		F	10/08/2009	racing heart, tight throat, lightheaded.  Advised to take benadryl and wait to see if change.  Approx 30 minutes later symptoms stopped									Y	10/07/2009	10/07/2009	0		PVT	UNK		10:00 racing heart, tight throat, lightheaded	renal failure			1						1	Dizziness; Palpitations; Throat tightness	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360110	10/08/2009	CA	27.0	27		F	10/08/2009	Started with itchy throat first I took a pill of Cipro 500mg for the UTI, then I started coughing. After that came the sore throat, fever, body aches, and head ache. By 7:30PM I was vomiting unable to get out of bed due to body shakes and body aches, also had eye discharge with redness and puffyness to both eyes. All these symptoms lasted for the rest of the night. The next morning I still had the same headache and facial swelling around my eyes, nose, and upper lip. I took two benadryl 25mg and Ibuprophen 600mg.									Y	10/06/2009	10/06/2009	0	NONE	PUB	PUB	Cipro 500mg	UTI	NONE			1						1	Activities of daily living impaired; Cough; Eye discharge; Eye swelling; Headache; Lip swelling; Ocular hyperaemia; Oropharyngeal pain; Pain; Pyrexia; Swelling face; Throat irritation; Tremor; Vomiting	FLUX~SANOFI PASTEUR~U3193AA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360111	10/08/2009	NY	32.0	32		M	10/08/2009	possible oculo-respiratory syndrome. The symptoms include red eyes, cough, wheezing, and chest tightness.				Y					U	10/08/2009	10/08/2009	0		PUB	PVT		no	none			1						1	Chest discomfort; Cough; Ocular hyperaemia; Wheezing	FLUX~UNKNOWN MANUFACTURER~113210AA~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360120	10/08/2009	MI	60.0	60		F	10/08/2009	Right arm swelled from elbow to shoulder couldn't lift arm, was cold in bed for 3 days.									Y	10/02/2009	10/03/2009	1	None	OTH	OTH	None	None	None			1						1	Activities of daily living impaired; Extensive swelling of vaccinated limb; Feeling cold; Injected limb mobility decreased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0632Y~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360121	10/08/2009	TX	57.0			F		circle of warm, red, sore and swollen appeared next day after shot. Still swollen, sore, red and warm 2 days after shot (flu)									U					OTH	OTH		Unknown	Unknown			1						1	Erythema; Pain; Skin warm; Swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360123	10/08/2009	PA	22.0	22		F		I administered the flu vaccine to patient and she told one her arm was tingling. Then it spread to her right arm then to her legs over the course of 2 hours.				Y					U	10/08/2009	10/08/2009	0		OTH	PVT	None	None	None			1						1	Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98432P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360126	10/08/2009	TX	86.0	86		F	10/08/2009	Upper R arm is swollen, 1 - 1 1/2 below the injection (1 x 1 1/2 in size) welt painful when moving R arm.									N	09/16/2009	09/17/2009	1	N/A	OTH	OTH	N/A	N/A	N/A			1						1	Injected limb mobility decreased; Injection site swelling; Injection site urticaria; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1162X~2~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360127	10/08/2009	TX	29.0	28		F	10/08/2009	Redness, itchiness around injection site right arm  x 2 days, resolved after 3 days.									Y	09/12/2009	09/13/2009	1	None	OTH	OTH		None	None			1						1	Injection site erythema; Injection site pruritus	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1162X~1~UN~LL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360128	10/08/2009	CA	4.0	4		F	10/08/2009	MOC c/o increased rash/redness on body trunk & extremities since yesterday afternoon.									U	10/07/2009	10/07/2009	0	None	PUB	PUB		None	None			1						1	Rash erythematous	DTAPIPVHIB~SANOFI PASTEUR~C3426AA~2~IM~UN~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~UT3178CA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEP~MERCK & CO. INC.~1678X~3~IM~UN~HEP B (RECOMBIVAX HB)~1|PNC~PFIZER\WYETH~D18702~3~IM~UN~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~0184Y~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0360131	10/08/2009	CA	67.0	67		F	10/08/2009	Received Flu vaccine (AFLURIA o.5cc) in Left deltoid on 9-24-09. Today on 10-8-09, Patient complains of residual taking Excedrin and soaking in warm bath. Pt. states she had no swelling, fever, chills. I recommended taking Ibuprofen or Aleve and f/u with physician.									N	09/24/2009	09/24/2009	0	N/A	OTH	PVT	Excedrin prn	None	None			1						1	Injected limb mobility decreased; Myalgia	FLU3~CSL LIMITED~08549111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360132	10/08/2009	WA	36.0	37		F	10/08/2009	Started having redness and swelling at shot site then developed swelling and redness in lymph node under left arm. Went to see convenient care doctor.				Y					Y	10/06/2009	10/07/2009	1	None	PVT	PVT	COZAR; PREMARIN	None	Peanut allergy; MORPHINE; ibuprofen			1						1	Injection site erythema; Injection site swelling; Lymphadenopathy	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA456BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0360133	10/08/2009	IL	7.0	7		F	10/07/2009	Epistaxis									Y	10/07/2009	10/07/2009	0	None	PVT	PUB	None	URI	Sinus Allergy			1						1	Epistaxis	FLUN3~MEDIMMUNE VACCINES, INC.~5000717P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360136	10/08/2009	IL	18.0	18		F	10/08/2009	After receiving flu shot for 1st time, c/o left arm numbness then left leg numbness.  Got up to walk around & said she wasn't feeling well.  Sat down BP 102/66.  Then 5 minutes later 100/64 (supine).  C/o breathing problems.  Gave 0.3 ml EPI in left arm below injection site.  Emergency squad called.  Taken to ER.				Y					U	09/30/2009	09/30/2009	0		PUB	PVT		No				1						1	Dyspnoea; Hypoaesthesia; Malaise	FLU3~SANOFI PASTEUR~U3179CA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360140	10/08/2009	MA	53.0	53		F	10/08/2009	Nausea, chills, headache night of vaccine. 9/15 legs and hands swelling. Then developed rash on legs, overnight swelling worse. Myalgias, nausea, chest pain sent to ER and admitted to hospital 9/12. Duodenal ulcer. 9/24 Transferred to another hospital. Diagnosis vasculitis (leukocytoclastic vasculitis) skin biopsy.  10/19/09:  Discharge Summary received for date of service 9/16/09-9/22/09.  Dx:  Henoch-Schonlein purpra with bowel involvement.  Assessment:  Presented with nausea, vomiting, leg weakness and achy neck and shoulders, fever and chills.  C/o feeling weak, fatigued, lightheaded and dizzy, calves were tight and painful.  Pt. noted a rash that began at her toes and went up her legs.  Rash was very small, red, non-itchy and non-painful.  Paleness noted on exam.  Tenderness in LUQ, midepigastric area and RUQ.  Multiple red hemorrhagic petechiae from toes circumfrentially up her legs, around her abdomen up to the mid-trunk area anteriorly and posteriorly. After abnormal upper endoscopy made NPO and placed on Proton pump inhibitors.  P. had episodic diarrhea with occasional passage of blood.  Started on IV antibiotic therapy.  Pt. was transferred to a higher level of care.     11/03/09 Medical records and Discharge Summary received for DOS 10/24-10/27. Final DX: Angitis.   Patient transferred to second facility for further eval by rheumatology. CT angiogram for vessel vasculitis neg. H/O of H pylori possible cause for GI ulcer sx.CT  for bloody diar showed large ascites, dilated loops small bowel, concern for ischemic bowel and vasculitis. Also R & L pleural effusion. CXR abnormal.  Stool and C diff cx neg. Hep A and C neg. Steroid therapy at other facility. Most likely hypersensitivity vasculitis s/t tetanus vaccine. Continued steroid therapy. ABX therapy. Sx improved greatly by d/c.			Y	Y	Y	13			Y	09/10/2009	09/10/2009	0	Biopsy skin leukocytoclastic vasculitis; Hematocrit dropped to 21; WBC up to 21.9.  10/19/09:  Discharge Summary received for date of service 9/16/09-9/22/09.  Labs and diagnostics:  Total Bili. 1.3 (H), neutrophils 78% (NL), CT of Abdomen-fluid distension of the third portion of the duodenum with surrounding edema in the retroperitoneum centered around the duodenum.   Upper endoscopy-scattered ulceration, marked edema and erythema of the distal duodemum, multiple large clots that had not passed were seen distally.  No active bleeding seen.  Skin biopsy-leukocytoclastic vasculitis, small vessel neutrophil-rich necrotizing vasculitis noted.  WBC 18.7 (H).   Labs & Diags: CT angiogram neg. CT abd/pelvis- ascites, dilated loops of small bowel, mucosal abnormality, concern for ischemic bowel. CXR - sml bil pleural effusions. CT abd, ascites,  anasarca, pleural effusion.  Glucose 123 (H), CA 8.0 (L),  ABS poly 8.1 (H), K 3.3 (L), CO2 34.2 (H), Creat .46 (L), RBC 3.25 (L), HGB 10.1 (L), HCT 28.4 (L), LYMPHS 15. (L),  WBC 10.0 (WNL),  CRP 2.7 (H), ALBUMIN 2.7 (L), ALK P 102 (H), ALBUM 2.7 (L),  TP 4.6 (L), Hep A, C neg.	PVT	PVT	TRAZEDONE; OMEPRAZOLE; LEXAPRO; Vit B Complex; WELLBUTRIN; Vit C	Physical & f/u, Depression; Tension headache	Penicillin?; Tetracycline-hives; Shellfish-hives. 10/19/09:  Discharge Summary received for date of service 9/16/09-9/22/09.  PMH:   Anxiety.  Allergies to Penicillin, Tetracycline, allergy to an unknown antiemetic, shellfish allergy.			1						1	Biopsy skin abnormal; Chest pain; Chills; Duodenal ulcer; Haematocrit decreased; Headache; Leukocytoclastic vasculitis; Myalgia; Nausea; Oedema peripheral; Rash; Vasculitis; White blood cell count increased	FLU3~SANOFI PASTEUR~U3201AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C3355AA~2~UN~LA~TDAP (ADACEL)~1	USA	Life Threatening,Hospitalisation	Influenza
0360141	10/08/2009	CA	54.0	54		M	10/08/2009	Came to pharmacy a.m. of 10/3/09 and stated he was getting a rash that was spreading over body - very itchy - also, one hand was very swollen and itchy. Took oral BENADRYL. As of 10/5 patient getting better.									U	10/02/2009				OTH	PVT		None	None			1						1	Oedema peripheral; Rash generalised; Rash pruritic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360143	10/08/2009	IL	64.0	64		F	10/08/2009	Bruise at injection site with a warm flat rash extending down arm and curving under arm. Patient had no fever.									Y	10/04/2009	10/05/2009	1	None	OTH	OTH	None	None	Unknown			1						1	Injection site haematoma; Injection site macule; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97842P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|VARZOS~MERCK & CO. INC.~0744Y~UNK~SC~RA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0360144	10/08/2009	MA	1.05	1	.1	F	10/08/2009	Hive on left buttock 24 hour after administration. Resolving with topical HYDROCORTISONE									Y	10/06/2009	10/07/2009	1	None	PVT	PUB	None	None	None			1						1	Urticaria	FLU3~SANOFI PASTEUR~U326261T~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~A1HNB287AB~1~IM~LL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~04834~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0994Y~1~SC~LL~VARICELLA (VARIVAX)~1	USA		Influenza
0360145	10/08/2009	IA	53.0	53		F	10/06/2009	Patient said arm has hurt for 12 days after shot - cannot raise above her head. Patient states she feels she has nerve damage. She was advised to see a physician.				Y					U	09/19/2009	10/01/2009	12		OTH	OTH		Mom reported				1						1	Injected limb mobility decreased; Nerve injury; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360146	10/08/2009	OH	23.0	23		F	10/08/2009	Patient receives FLUVIRIN flu shot. She said was not as bad as she thought. I told her to sit then she fainted sitting in chair then fell on floor. I proceed to do CPR but she became conscious and talking. She was not itching and no hives. Call 911. EMT's came took vitals and took her to hospital.				Y						10/08/2009	10/08/2009	0		OTH	PVT	YAZ	None	None			1						1	Fall; Loss of consciousness; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360147	10/08/2009	VT	45.0	45		F	10/06/2009	Left arm deltoid tenderness, swelling, no redness with some left hand swelling requiring pt to remove ring from 4th digit. 25 mg PO BENADRYL and ice to L arm.									U	10/06/2009	10/06/2009	0	None	PUB	PUB	loratadine; KLONIPIN; METHYLIN; PROZOSIN; PEPCID; METFORMIN; ZOCOR; glyburide		Hyperlipidemia; DM; depression/agoraphobic; asthma; allergy-PENICILLIN; TRAMADOL			1						1	Injection site pain; Injection site swelling; Oedema peripheral	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA281AA~1~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0360148	10/08/2009	TN	50.0	50		F	10/08/2009	Patient reports onset weakness, intermittent dizziness with redness and warmth of injection site on 10/6/09 no fever. Rt arm (injection) sore. States area is approximately 5 1/2  long x 2 1/2  wide red, firm and warm to the touch. She called her MD. No treatment. Did not want to come to office. Pt has history feels better today.									N	10/05/2009	10/06/2009	1		PUB	OTH	None	None	History breast cancer; Left mastectomy; CAD; Allergies: Codeine, latex, tape			1						1	Asthenia; Dizziness; Injection site erythema; Injection site induration; Injection site pain; Injection site warmth	FLU3~SANOFI PASTEUR~U3195AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0509Y~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360149	10/08/2009	WV	44.0	44		F	10/01/2009	Raised red rash on anterior posterior thighs groin area; buttocks and back.									N	09/29/2009	10/01/2009	2		PUB	OTH	Multi Vitamin		None			1						1	Rash erythematous; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA4700A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0360150	10/08/2009	MA	5.0	5		F	10/06/2009	Awoke from nap Saturday 10/3 & swelling of L arm; arm warm to touch. Fever of 103 F 10/3 night. Seen by Pediatrician 10/4 and lines drawn around redness & swelling. Erythema extended past lines. Started on Keflex for cellulitis. To ER 10/5 for x-ray of extremity which was negative.				Y					Y	10/01/2009	10/03/2009	2		OTH	UNK						1						1	Cellulitis; Erythema; Oedema peripheral; Pyrexia; Skin warm; X-ray normal	FLU3~SANOFI PASTEUR~U3196AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360151	10/08/2009	CT	70.0	70		F	10/08/2009	Pt had vaccine on 10/1/09. Next day came in with 4 a.m. under vaccine arm site was a 16 x 8 cm cellulitis horizontally around circumference of arm. It was the right arm. Pt was tender by vaccine injection site and slightly swollen.									Y	10/01/2009	10/02/2009	1	Pt was treated with AUGMENTIN 875mg twice a day for 10 days	PVT	PVT	CRESTOR; ACTIGALL; ASPIRIN; PROTONIX; SYNTHROID; METOPROLOL	Dizziness	Hyerptension; Hyperlipidemia; Left carotid artery; pulse decreased; stenosis of ampulla of vater			1						1	Injection site cellulitis; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U3209AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~00374~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360152	10/08/2009	CA	51.0	51		F	10/08/2009	Approximately 10-15 minutes after receiving the below mentioned flu vaccine, patient states she felt nauseated,  clammy and felt like a hot flash. VS stable. Evening of 10-06-09 and day of 10-07-09, patient experienced temp. to 99.9 degrees, pulse to 106, body aches, decreased appetite, nausea, patient felt well 10-08-09 and returned to work.									Y	10/06/2009	10/06/2009	0		PVT	PVT	Juice plus calcium; RESVERATROL; Glucosamine/Chondroitin;  PERFECT FOOD; Vitamin D	None	No known allergies; no birth defects; patient diagnosis of senile osteoporosis, palpitations, and female climacteric state			1						1	Cold sweat; Decreased appetite; Heart rate increased; Hot flush; Nausea; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA265AA~2~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0360155	10/08/2009	WA	75.0	75		M	09/16/2009	Pt had a rash on the abdominal area next to the navel area after administering ZOSTAVAX on 9/3/09. Pt reported rash on 9/15/09.									N	09/03/2009	09/14/2009	11		OTH	OTH	methadone; metoprolol; trazodone; LISINOPRIL; BUSPAR	None that was known	NKDA; hypertension; insomnia; osteomalacia			1						1	Rash	FLU3~SANOFI PASTEUR~U3190AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~1561X~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0360156	10/08/2009	NV	67.0	67		M	10/06/2009	Patient reported increased blood pressure and 103 degree temperature 3 days after vaccine administration which sent him to ER.				Y					Y	09/30/2009	10/03/2009	3	Unknown	OTH	PVT	ALPRAZOLAM 2 mg; LISINOPRIL 2.5 mg	None	Unknown			1						1	Blood pressure increased; Body temperature increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98437PA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~06274~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0360157	10/08/2009	WA	66.0	66		F	10/08/2009	Localized Bruising on the site of injection and upper arm near the injection site.									U	10/06/2009	10/06/2009	0		OTH	PUB			Allergic to Sulfa, Tetracycline			1						1	Injection site haematoma	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98441P1~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360158	10/08/2009	IL	54.0	54		F	09/29/2009	Vaccine received 9/23/09 afternoon in left deltoid. Usual anticipated muscle soreness 9/23 and 9/24. On 9/25/09 pain increased and extended to left forearm and involved elbow. Managed pain with ibuprofen q 6 hr for 3 days but continued to worsen. 9/26/09 unable to grasp items due to pain. 9/28/09 lessening of pain. 9/29/09 continued aching pain which becomes sharp stabbing pain at elbow when attempt to carry or pull more than 10 pound item.									N	09/23/2009	09/25/2009	2		PUB	OTH	multivitamin daily; calcium carbonate 600 mg BID	None	NKA-no health issues			1						1	Arthralgia; Grip strength decreased; Injection site pain; Myalgia; Pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA476AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0360159	10/08/2009	TX	47.0	47		F	10/08/2009	Large red circle, itching, location very warm to touch.									U	10/06/2009	10/07/2009	1		OTH	UNK		None	None			1						1	Erythema; Pruritus; Skin warm	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360112	10/09/2009	SC	48.0	48		F	10/08/2009	Extreme soreness at the injection site, but no redness, muscle weakness, dizzyness, joint pain, muscle aches, lowgrade fever (+ 2degrees), severe headache, and overwhelming exhaustion - difficulty walking. Lasted approximately 18 hours.  Peaked 4 hours after onset of symptoms. All symptoms gone by next evening except lingering fatigue and headache, and soreness at the injection site.									Y	09/21/2009	09/21/2009	0	None	PVT	PVT	Adderall60mgqd   Calcium+vitD600mgbid  Chromium 800mgqd  Lamictal200mgbid  Melatonin600mcgqd  Miralax17gqd Prilosec OTC20mgbid  Singulair10mgqd Synthroid175mcgqd Topamax200mgbid Wellbutrin XL450mgqd	No	Hypothyroidism, Asthma, Migraine,  Allergic to Demeral, Versed	similar to above/milder~Influenza (Seasonal) (no brand name)~~47.00~Patient|similar to above/milder~Influenza (Seasonal) (no bra		1						1	Arthralgia; Dizziness; Fatigue; Gait disturbance; Headache; Injection site pain; Muscular weakness; Myalgia; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360113	10/09/2009	AL	6.0	6		M	10/09/2009	MY SON BROKE OUT IN WHAT APPEARED TO BE BUG BITES AND HE W AS REAL ITCHY THEN IT SPREAD FROM HIS NECK TO UNDERARMS CHEST SCALP STOMACH LEGS AND FEET				Y					Y	10/08/2009	10/08/2009	0		UNK	UNK		none	none			1						1	Rash pruritic	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500757P~1~PO~MO~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA	Emergency room visit	Influenza
0360114	10/09/2009	CA	26.0	26		F	10/09/2009	I started coughing a lot around 3:00p.m. After about thirty minutes of constant coughing I had trouble swallowing and I felt like something hard was stuck in my throat. I was drinking plenty of water not knowing what was causing the problem. Soon after I was getting dizzy and was having a difficult time breathing. My chest felt very tight and it was painful when I would take a deep breath. At this point I was weak and my eyes were red and swollen. I contacted my primary physician and I was told to take 25mg of Benadryl per mouth and to go to the nearest emergency room. I was unable to drive, my co-worker transported me to the hospital. When we arrived at hospital at approximately 4:15p.m. I was very weak, had a lot of chest pain, difficulty breathing and I had a difficult time walking due to the weakness I felt. I was immediately checked in the emergency room and they gave me a cortisone injection intramuscular. They had me under observation and took two radiographs of my chest. After several hours of observation I was released that same night. I was very tired and felt weak, still unable to drive myself home.				Y					Y	10/06/2009	10/06/2009	0	Radiographs	UNK	UNK	200mg of Ibuprofen that morning	No	No			1						1	Asthenia; Chest X-ray; Chest discomfort; Chest pain; Cough; Dizziness; Dysphagia; Dyspnoea; Eye swelling; Fatigue; Gait disturbance; Impaired driving ability; Ocular hyperaemia	FLUX~UNKNOWN MANUFACTURER~~1~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360115	10/09/2009	OH	57.0	57		F	10/09/2009	At 9:30 pm sudden onset of bad frequent cough. Cough stopped at 10:30. Woke up at 12:30 am with chills, fever, sore throat, racing heart, fast breathing, aches.									U	10/08/2009	10/08/2009	0		UNK	UNK	Prilosec OTC for acid reflux. Prescription Vitamin D	None	None			1						1	Chills; Cough; Oropharyngeal pain; Pain; Palpitations; Pyrexia; Respiratory rate increased	FLU3~SANOFI PASTEUR~UT3251BA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360124	10/09/2009	NY	65.0	65		F	10/09/2009	Chills, Nauseas Fever severe headache				Y					U	10/08/2009	10/08/2009	0	Blood Test negative	UNK	UNK		No	Allergic to bee stings.  COPD			1						1	Blood test normal; Chills; Headache; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360125	10/09/2009	MI	57.0	57		F	10/09/2009	Began w/achy feeling in body then approx. 45 min later began to have severe stomach ache and nausea, at about 2:30 pm began to feel swelling in back of throat near soft palate and within 30min swelling traveled further down throat near adams apple area became very hoarse and harsh cough when trying to speak. Called 911/ Tx ED				Y					Y	10/07/2009	10/07/2009	0	Influenza a&b negative, cbc & electrolyes WNL, urine c&s &u/a neg.CXR neg.	UNK	UNK		No	aspirin, No other allergies or illnesses		MI	1						1	Abdominal pain upper; Blood electrolytes normal; Chest X-ray normal; Cough; Culture urine negative; Dysphonia; Full blood count normal; Influenza serology negative; Nausea; Pain; Pharyngeal oedema	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360154	10/09/2009	TN	1.01	1	.0	F	10/06/2009	Welt approximately 50 cent size at site of injection. Instructed mother to use hydrocortisone cream at the site.									Y	10/06/2009	10/06/2009	0	None	OTH	PUB	None	None	None			1						1	Injection site urticaria	FLU3~SANOFI PASTEUR~UT3178DA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB327AA~1~UN~RL~HEP A (HAVRIX)~1|MMR~MERCK & CO. INC.~0618Y~1~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0999Y~1~UN~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0360161	10/09/2009	MO	71.0	71		M	10/08/2009	R eye reactions redness, watery, irration, pain. -similiar reaction, in left eye-lighter reaction. -upper R eyelid was swollen. polydex-eyedrops, polydex ointment, cold compress 2 tylenol, benadryl 25 mgs. Some discomfort was able to sleep. ZADITOR-2 times day in eyes.										10/06/2009	10/06/2009	0	No	PVT	PUB	Pulmicort-12.5 ml Asthma Levoxyl-0.15 ml-thyroid MultiVatiman CoQ 10-100 mL Fiber therapy-2 tablets Enteric Coated Aspirin 81 mL-Preventive heart blockage Crestor 20 mL-Chloestrol Singulair 10 mL-Antihistamine Nasonex Spray-Nasal Congestion	No	No			1						1	Discomfort; Eye irritation; Eye pain; Eyelid oedema; Lacrimation increased; Ocular hyperaemia	FLU3~SANOFI PASTEUR~03173DA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360171	10/09/2009	NY	50.0	50		F	10/07/2009	Patient c/o localized rash at injection site, fever of 102.5, headache and nausea at 7pm the evening same day vaccine administered, treated with MOTRIN and BENADRYL - no SOB, cough, CP follow up with MD on 10/06/2009.				Y					Y	09/29/2009	09/29/2009	0		PUB	PVT	None	None	None			1						1	Headache; Injection site rash; Nausea; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA259AA~1~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0360172	10/09/2009	IN	74.0	74		M	10/17/2009	Hives on back, stomach, legs, arms									U	10/07/2009	10/07/2009	0	None	OTH	PUB	Nothing new	None	High blood pressure; Prostatic Hypertrophy; Kidney dx			1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98433P1~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360173	10/09/2009	MA	67.0	67		M	10/02/2009	Initial report received on 28 September 2009 from an investigator in the above mentioned trial. A 67 year old male subject developed high grade fever on 22 September 2009 few hours after receiving an injection of FLUZONE SV 2009-2010 on 22 September 2009. The subject had a medical history of diabetes since 1999 and was on unspecified medication. On 22 September 2009, the subject returned to the site with fever of 101.9 degree Fahrenheit. The investigator referred the subject to the nearest emergency room. The subject received corrective treatment with Magnesium Oxide 400mg orally. The event high grade fever resolved the next day on 23 September 2009. According to the investigator, the event was related to the study vaccine. The serious adverse event did not lead to the termination of the subject from the study. No documents were held by the sender.				Y					Y	09/22/2009	09/22/2009	0	Not provided.	UNK	UNK			The subject had medical history of diabetes since 1999 and he was on unspecified medication.		200904110	1						1	Pyrexia	FLU3~SANOFI PASTEUR~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360174	10/09/2009	PA	59.0	59		M	10/06/2009	Initial report was received on 28 September 2009 from a health care professional. A 59-year-old male patient with a history of diabetes and high blood pressure had received an injection of FLUZONE SV 2009-2010, lot number U3184AA, (route and site of administration not reported) on 08 September 2009 and an unspecified amount of time later that same day, he developed higher blood sugar levels in the evening. According to the reporter, levels were higher than usually are; running about 240. The patient had been taking ADACAN, Metformin: and Novalog concomitantly and he had no concurrent illness and no known allergies. At the time of the report, the patient had not reported to their health care provider and their recovery status was unknown. Documents held by sender: None				Y					U	09/08/2009	09/08/2009	0	Blood sugar values are higher in evening; higher than usually are - running about 240.	UNK	UNK	ADACAN; METAFORMIN; NOVALOG		The patient had a past history of diabetes and high blood pressure.		200904126	1						1	Blood glucose increased; Condition aggravated; Diabetes mellitus	FLU3~SANOFI PASTEUR~U3184A~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360177	10/09/2009	NJ	48.0	48		F	10/06/2009	Initial report received on 01 October 2009 from a consumer, who is a physician. A 48 year old female patient with no reported medical history developed a sore throat, low grade temperature of 99.3 orally, lethargy, and body aches one day after she received FLUZONE No preservative 2009-2010 (lot number U3173DA) intramuscularly in the left deltoid. The symptoms were severe enough to cause loss of work for a few days. The patient was improving, but not fully recovered. The patient reported that the same reaction occurred with a prior influenza vaccine (manufacturer was not provided) which was administered in the late 80's, early 90's. No further information was provided. List of Documents held by sender: none.								Y	N	09/20/2009	09/21/2009	1	none	PVT	PVT	FLEXERIL		Patient was taking FLEXERIL concomitantly. Past medical history was reported as none. The patient reported the same reaction occurred with a prior influenza vaccine which was administered in the late 80's, early 90's.	sore throat, Lethargy, fever, generalized muscle aches~ ()~~0.00~Patient	200904158	1						1	Activities of daily living impaired; Body temperature increased; Lethargy; Oropharyngeal pain; Pain; Vaccine positive rechallenge	FLU3~SANOFI PASTEUR~U3173D~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Disabling	Influenza
0360186	10/09/2009	MA	62.0	62		M	10/09/2009	Hives reported all over his body. Took benadryl with relief.									Y	10/06/2009	10/06/2009	0	none done	PUB	PUB		No illness reported	NKDA			1						1	Urticaria	FLU3~SANOFI PASTEUR~U3188AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360189	10/09/2009	VA	53.0	53		F	10/09/2009	Fever, body aches, soreness and some swelling at injection site; by 9:00 sore eyes, light flashes before eyes, weakness, dizziness with difficulty standing upright; by 3:00 am fever diminished, with drenching sweat, mild stomachache; by 7:00 am all symptoms gone except sore arm and mild stomachache.									Y	10/08/2009	10/08/2009	0	none	UNK	UNK		Diabetes	None			1						1	Abdominal pain upper; Asthenia; Dizziness; Dysstasia; Eye pain; Hyperhidrosis; Injection site pain; Injection site swelling; Pain; Pyrexia; Visual impairment	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360191	10/09/2009	IN	1.08	1	.1	M	10/09/2009	MOM CALLED OFFICE STATING HE WOULD NOT STAND OR WALK, PAIN IN LEGS. NO BRUISING OR SWELLING, WAS SEEN IN OFFIC ON 10/9/09 AND NO TREATMENT GIVEN									Y	10/01/2009	10/07/2009	6	NONE	PUB	PUB		NONE NOTED AT TIME OF VACCINE	NONE			1						1	Dysstasia; Gait disturbance; Pain in extremity; Abasia; Crying; Muscle strain; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~~~INFLUENZA (SEASONAL) (FLUARIX)~1|HEPA~MERCK & CO. INC.~~UNK~~~HEP A (VAQTA)~1|MMR~MERCK & CO. INC.~~UNK~~~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~~UNK~~~VARICELLA (VARIVAX)~1|FLU3~SANOFI PASTEUR~U3259CA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~2|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAUB312AA~1~IM~LL~HEP A (HAVRIX)~2|MMR~MERCK & CO. INC.~0679Y~1~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~2|VARCEL~MERCK & CO. INC.~1005Y~1~SC~LA~VARICELLA (VARIVAX)~2	USA		Influenza
0360192	10/09/2009	FL	6.0	6		M	10/09/2009	SKIN REACTION, ERYTHEMA 8CM X 7 1/2CM, NO SIGN INDURATION, NOT PAINFUL, NOT ITCHING									Y	10/07/2009	10/08/2009	1		PVT	UNK		NO				1						1	Erythema; Skin reaction	FLU3~SANOFI PASTEUR~U3190AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360193	10/09/2009	NC	8.0	8		M	10/09/2009	edema and redness at injection site, seen on 10/9/2009 and gevin keflex, and told to continue Bendryal				Y					Y	10/05/2009	10/06/2009	1		PVT	PVT		His left outer upper shoulder, kind of on his outer biceps muscle, there is a 5 cm area of erythema and warmth.  There is no streaking.  It is not tender to touch.  He does say it itches some.  There is no fluctuance.  ASSESSMENT AND PLAN: This is an 8-year-old male who potentially had an allergic reaction to the vaccine.  I do not think it was a reaction to egg because it was in such a localized area, so he had a local reaction that is now superinfected with a likely cellulitis.  I am going to have him continue Benadryl 1-1/2 teaspoons every 6 hours and I am prescribing 7 days of Keflex.  If it is getting worse, streaking or he has fevers, should let me know immediately.	None			1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~UE174EA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360195	10/09/2009	NC	6.0	6		M	10/09/2009	The patient got a flu vaccine last night and now has significant edema and erythema of his left upper arm.  His brother had a flu vaccine two days before and also had significant erythema and edema.  It has started to go down with Benadryl and cephalexin.  The patient has also had a previous episode of erythema and edema with a vaccination, which was thought to be the polio vaccine.  This same sort of symptoms were present for that. We discussed the ingredients of the flu vaccine and at this point, I do not know what he specifically had that could have caused a reaction.  He has had eggs before and it is unlikely that this is a reaction to eggs.  However, I do not want him to get the injectable flu vaccine any more.  He has had FluMist vaccines in the past.  We will record this as an adverse reaction.  Benadryl is the best thing in the meantime for edema and they will call if it is persisting.				Y					Y	10/07/2009				PVT	PVT		none	none	edema redness at site~Influenza (Seasonal) (Fluzone)~1~8.67~Sibling|edema redness at site~Polio Virus, Inact. (no brand name)~UN		1						1	Injection site erythema; Injection site oedema	FLU3~SANOFI PASTEUR~U3173AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360197	10/09/2009	NY	49.0	49		F	10/09/2009	Employee began to develop pruritus without rash.  Began feeling weak and sweaty.  She started shaking and was reported to become extremely pale.  Felt she was going to pass out.  Was assisted in lying down.  Rested for about one hour and was driven home where she went to bed for the remainder of the night.  Feels her usual self this morning except for a new area of erythema distal to the injection site.  Area not indurated or excessively tender or warm to touch.  Warm pack applied and advised to see MD if area worsens.  Possible cellulitis.									Y	10/08/2009	10/08/2009	0	None	PUB	PUB	Takes no medications	No	Seasonal allergies			1						1	Asthenia; Hyperhidrosis; Injection site erythema; Pallor; Pruritus; Tremor	FLU3~SANOFI PASTEUR~V3186AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360198	10/09/2009	MA	60.0	60		F	10/09/2009	Pt reports sore on right underside of tongue and painful right nipple									Y	10/02/2009	10/04/2009	2		PVT	PVT		no	none			1						1	Breast pain; Glossodynia	FLU3~SANOFI PASTEUR~aflua449ba~5~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360199	10/09/2009	NH	1.64	1	.6	M	10/09/2009	Patient was given the FLUMIST Nasal Spray versus the injection.  This is not recommended for children under 2.  Was given in error.  Patient is a healthy 19month old.   I was looking at the wrong VIS sheet recommendations.										10/09/2009	10/09/2009	0		UNK	UNK	none	none noted	club foot otherwise healthy			1						1		FLUN3~MEDIMMUNE VACCINES, INC.~500705P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360200	10/09/2009	MA	14.0	14		M	10/09/2009	Syncopal episode in bathroom when trying to get into shower.  Felt dizzy,fell,hit top of head on sink, LOC for approx 45 seconds.  Arrived at office dizzy and hypotensive.  Drank 2 Liters of gatorade, observed for 1 hour, felt better and BP increased to 102/65.  Discharged home.  F/U later in evening doing well, no temp or dizzyness.  10/14/09 Received medical records. Date of Service 10/6/09. Dx:  Severe Vaccine Reaction. Presenting sx:  Pt. woke up and experienced dizzyness in the bathroom.  He had an episode of syncope and hit his head on the sink.  He presented with a headache, paleness,  fever, and unstable hypotension.  He drank 2 Liters of Gatorade and was walking and feeling good at time of discharge from physicians office an hour and 20 minutes later.									Y	10/06/2009	10/07/2009	1	10/14/09 Received medical records. Date of Service 10/6/09.  Labs and Diagnostics:  None.	UNK	UNK		no	no.  10/14/09 Received medical records. Date of Service 10/6/09. PMH:  None.			1						1	Dizziness; Fall; Head injury; Hypotension; Loss of consciousness; Syncope	FLUN3~MEDIMMUNE VACCINES, INC.~500675P~5~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|MNQ~SANOFI PASTEUR~U2917AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~UF460CA~1~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0360201	10/09/2009	FL	51.0	51		F	10/09/2009	Developed pain and weakness in left shoulder. Seen for evaluation on 10/9/09 and clinically appeared to have rotator cuff tendonitis involving the supraspinatus and teres. Had complaint of weakness in the arm but could not confirm on testing as exam limited by pain.				Y					N	09/18/2009	09/19/2009	1		PVT	PVT		none	ON 9/18/09 told me she had eye sensitivity to thimerosol in the past when using contacts			1						1	Muscular weakness; Musculoskeletal pain; Rotator cuff syndrome	FLU3~SANOFI PASTEUR~U3200AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360214	10/09/2009	TX	61.0	61		F	10/09/2009	had been itching since shot but started feeling like my throat was closing, had heart palpatations, and felt nauseated. Took 50mg of benedryll and symtoms started improving within 20 minutes but itched almost all of next day.									Y	10/06/2009	10/06/2009	0		UNK	PVT		No	Codeine, metal allergy HB Pressure (under control			1						1	Nausea; Palpitations; Pruritus; Throat tightness	FLU3~SANOFI PASTEUR~~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360215	10/09/2009	VA	12.0	12		M	10/09/2009	Has diabetes, received a FLUZONE for 8 yro-no problems-PM 10/5-50 cent swelling, hot tired, achy, went on to school, felt better by Thurs. 10/8, swelling better also by 10/8.									Y	10/05/2009	10/05/2009	0		OTH	OTH	Insulin	No	IDDM on insulin pump			1						1	Fatigue; Feeling hot; No reaction on previous exposure to drug; Pain; Swelling	FLU3~SANOFI PASTEUR~U3214AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360216	10/09/2009	VA	45.0	45		M	10/09/2009	Received vaccine 10/5/09 fu - several hours later swelling 50 cent size. digestive problems, diarrhea, flushed felt hot, achy, didn't feel well, HA, took TYLENOL - did not feel better until 10/9/09 - No PMD follow up. Pt attached had problems also-									Y	10/05/2009	10/05/2009	0	None	OTH	OTH	None	None	None			1						1	Diarrhoea; Dyspepsia; Feeling hot; Flushing; Headache; Malaise; Pain; Swelling	FLU3~SANOFI PASTEUR~3214AA~7+~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360217	10/09/2009	VA	49.0	49		F	10/09/2009	On Omnicef 1 wk prior to flu-resp sx's - on Levaquin day of, felt ok, no temp. PM-arm swollen, very hot to touch, tender, moving her arms. She felt area, school nurse practitioner saw Mon 10/5-9 cm area, red-reported to us on 10/8/09 area better by Wed 10/7-receive vaccine 10/2/09-no MD follow up-no other sx's reported.									Y	10/02/2009	10/02/2009	0	NA	OTH	OTH		None	Hx of asthma			1						1	Erythema; Oedema peripheral; Pain; Skin warm; Tenderness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97845P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360218	10/09/2009	VA	60.0	60		F	10/09/2009	She took flu vaccine last year OK, prior not a vaccine for a number of years. Vaccine given 10/6-given AM-Tues. PM- reddened. Wed. AM 10/7-she could feel area when she moved her arm, 50 cent area. On 10/8 school nurse practioner reports 6-7 cm area. No other sxs, no PMD follow up. Today 10/9 area better.									Y	10/06/2009	10/06/2009	0	None	OTH	OTH		None	Food allergies, not to eggs			1						1	Erythema; No reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~U3214AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360219	10/09/2009	MI	15.0	15		F	10/02/2009	4cm X 3cm erythematous, warm to touch, red, swelling to area									U	09/30/2009	10/01/2009	1	None	PVT	OTH	NEXIUM 40mg 1 daily	Cough, fatigue, ear pain	GERD			1						1	Erythema; Skin warm; Swelling	FLU3~SANOFI PASTEUR~U3177BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U2728AA~UNK~ID~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|VARCEL~MERCK & CO. INC.~0692Y~UNK~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0360220	10/09/2009	NJ	6.0	6		F	10/09/2009	Cellulitis Left arm after receiving seasonal flu vaccine via pharmajet. Shoulder to elbow red, hot, swollen. Emergency room visit. Prescribed BACTRIM. Above noted 10/8 pm.				Y					U	10/07/2009	10/08/2009	1		PUB	PVT	None	None	Allergy - PCN; Hx asthma			1						1	Cellulitis; Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3177AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360221	10/09/2009	KY	59.0	59		F	10/09/2009	Pt developed multiple large, raised, red areas all around arm and going up shoulder. Painful to touch. R arm.				Y					U	10/06/2009	10/07/2009	1		PVT	PVT	THEO-DUR; CLARITIN; LIPITOR; captopril/hctz; BRETHINE; CHANTIX	Sinusitis	Seasonal allergies; asthma; HTN; depression			1						1	Erythema; Injection site erythema; Injection site pain; Injection site rash; Pain in extremity; Rash macular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97844P2~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0024Y~1~UN~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0360222	10/09/2009	MO	1.53	1	.5	F	10/09/2009	Approx 2 hours after vaccination - seizure activity/fever taken to hospital via ambulance - temp 103.3. Nausea/vomiting - arrived in ER at 7:32 p.m. - given MOTRIN for fever. ZOFRAN for vomiting. IV fluids - temp 99.6  ax in ER labs, x-rays done, released to home at 9:20 pm				Y					Y	10/08/2009	10/08/2009	0	Lab work done - WNL (WBC) - chest x-ray neg - strep screen neg, throat/ears WNL - will follow-up with pediatrician .	PUB	PUB	None	None	None			1						1	Chest X-ray normal; Convulsion; Ear, nose and throat examination normal; Emergency care; Fluid replacement; Nausea; Pyrexia; Streptococcal identification test negative; Vomiting; White blood cell count normal	FLU3~SANOFI PASTEUR~UT3178FA~1~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360223	10/09/2009	MO	76.0	76		M	10/09/2009	Woke up next day with back and muscle pain in chest and back. Difficulty breathing.				Y					U	09/17/2009	09/18/2009	1	Unknown	OTH	PUB		No	None known			1						1	Back pain; Chest pain; Dyspnoea; Myalgia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P1~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360225	10/09/2009	GA	59.0	59		F	09/23/2009	10 days later injection site still has soreness & pain with movement. Patient complained occassionally has mild spasm with pain even when not moving her arm. She has been taking Tylenol for pain off & on.									U	09/11/2009	09/12/2009	1		OTH	OTH	Unknown	Unknown	Unknown			1						1	Injection site pain; Muscle spasms	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960325P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360226	10/09/2009	MO	73.0	73		F	10/09/2009	Weakness, chest wall, shortness of breath, some dizziness				Y					U	09/17/2009	09/20/2009	3	Unknown	OTH	PUB	None	None	None			1						1	Asthenia; Chest discomfort; Dizziness; Dyspnoea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P1~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360227	10/09/2009	GA	27.0	27		F	10/09/2009	Bruise on injection site x 3 days.									Y	10/05/2009	10/07/2009	2	None	OTH	PVT	TOPROL XL; ZOLOFT; NUVARING	None	POTS			1						1	Injection site haematoma	FLU3~GLAXOSMITHKLINE BIOLOGICALS~U32523DA~1~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0360231	10/09/2009	WA	39.0	39		F	10/09/2009	Within moments of vaccine administration, patient reported not feeling well, dizzy, wanted to lie down after lying down, feet elevated, she reported her throat feeling tight, face flushed, around mouth feeling numb, heart feeling fast. HR ED, BP 140/80 911 called, pt transported to Emerg Dept (went to hosp)				Y					U	10/08/2009	10/08/2009	0	None	PUB	PUB	Birth control pills	None	None			1						1	Dizziness; Flushing; Hypoaesthesia oral; Malaise; Palpitations; Throat tightness	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~5007649~1~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA	Emergency room visit	Influenza
0360233	10/09/2009	SC	64.0	64		M	10/09/2009	Patient reported having a bug bite then getting the flu shot. He reported a rash beginning 2 days after the immunization. He was to urgent care twice. The first time he was given hydrocortisone cream and oral diphenhydramine. He presented to urgent care a week later and the rash had not gone away. He was given oral methylprednisolone to accompany the hydrocortisone cream and diphenhydramine.				Y					U	09/02/2009	09/04/2009	2	Biopsy done by private dermatologist, results unknown.  Vital Signs from 9/13/09 urgent care visit. Temperature:    97.5 Pulse:          71 Respiration:    18 Blood Pressure: 152/86 Pain:           0 Pulse Ox:       97 Height: 73 in [185.4 cm] WEIGHT: 253 lb. (115.00 kg.)	MIL	MIL	1)   DIPHENHYDRAMINE HCL 25MG CAP TAKE ONE CAPSULE BY MOUTH EVERY 6 HOURS IF NEEDED FOR SLEEP FOR RASH AND ITCHING 2)   HCTZ 12.5/LISINOPRIL 20MG TAB TAKE 2 TABLETS BY MOUTH EVERY MORNING FOR BLOOD PRESSURE. BLOOD PRESSURE GOAL IS TO HAVE B	No infectious illnesses.	Hypertension, hyperlipidemia, and osteoarthritis.			1						1	Biopsy; Rash	FLU3~CSL LIMITED~07449111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0360234	10/09/2009	IL	87.0	87		M	10/09/2009	chills and nausea evening after the vaccine and the next morning could not lift his arm				Y						10/07/2009	10/07/2009	0		PVT	UNK		on 8-09 pt had CABG, followed by pulmonary embolism	Charcot-Marie-Tooth, osteopenia, MVP, on anticoagulation, coronary artery disease, PE			1						1	Chills; Injected limb mobility decreased; Nausea	FLUX~SANOFI PASTEUR~UT3172BA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0024Y~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0360235	10/09/2009	GA	2.0	2	.5	F	10/09/2009	Very High fever 105 with temporal artery thermometer, put straight in tub to cool down, and administered tylonol, fever reduced to 102 rectally, with alternation between tylonol and motrin fever is staying between normal and 100									U	10/07/2009	10/08/2009	1	none	PUB	PVT	none	no	none			1						1	Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360237	10/09/2009	ME	5.0	5		M	10/09/2009	Dad reports that patient woke up during the night (due to bad weather - was scared) but found him to be warm.  No fever at school when checked at lunchtime, but 100.7 at 3 p.m.  Dad reports child was 100.1 upon arrival home.  He has also complained of a headache and sore throat. Mom called school this am to report that Pt would be out of school again today due to a fever and stuffy nose. Brought to MD today whom felt it was related to FluMist administration on 10/7/09 per Mom.									N	10/07/2009	10/08/2009	1		UNK	UNK		None noted, but per classroom teacher reports he has been very mucousy since school started.  Often has runny nose.  Did not appear to have any nasal congestion at time of administration.	N/A			1						1	Headache; Oropharyngeal pain; Pyrexia; Skin warm	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360238	10/09/2009	TX	14.0	14		F	10/09/2009	Per parent and EMS, patient had a fainting episode.  Blood pressure was checked but everything was fine.  Verified with father 10:00am 10/09/2009.									Y	10/08/2009	10/08/2009	0		UNK	UNK	Not available	None	Not Available			1						1	Blood pressure normal; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960305P~1~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360239	10/09/2009	MN	53.0	53		F	10/09/2009	Shot was not given in the deltoid. Injection was given in wrong location. Caused are to be red, swollen and warm to touch. Greater care to ensure proper location used for giving an IM.									Y	09/22/2009	09/23/2009	1		PUB	PVT		none	none			1						1	Drug administered at inappropriate site; Injection site erythema; Injection site swelling; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA448AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0360240	10/09/2009	MO	32.0	32		F	10/09/2009	Rash, itching Benadryl PO									Y	10/09/2009	10/09/2009	0		PUB	UNK		No	Sulfa Tylenol	Itching~Influenza (Seasonal) (no brand name)~~25.42~Patient		1						1	Pruritus; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~5007251~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360241	10/09/2009	OH	46.0	46		F	10/09/2009	Red, Itchy Eyes Tightness in chest Temp 101 Pulse Oximetry at ER 91%				Y					Y	10/08/2009	10/08/2009	0		PUB	PVT		None	None			1						1	Body temperature increased; Chest discomfort; Eye pruritus; Ocular hyperaemia	FLU3~SANOFI PASTEUR~U3195AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360242	10/09/2009	CA	0.79	0	.8	F	10/09/2009	Fever (103.7) and cough on 10/8/09. Hospitalized with seizure on 10/8/09 - admitted through ER.  10/19/09:  Emergency Department records received for date of service 10/8/09.  Dx:  Complex febrile convulsion. Assessment:  Pt. was ill during the day with a febrile flu-like illness, appearing lethargic.  Began to have a tonic seizure involving the entire body while at home and continued in ambulance for approximately 20-30 minutes.  Medicated with Ativan with no results, so Versed was given.  Febrile with tachycardia upon admission to the ED. O2 sats. remained at 100%.  A lumbar puncture, CT scan and chest x-ray were all done.  Started on IV fluids for possible fluid depletion.  Medicated with Acyclovir, Rocephin and phenobarbital.  Transferred to a higher level of care.   ICD Code:  780.32				Y	Y					10/06/2009	10/08/2009	2	CBC; Blood Cx and H1N1 test ordered on 10/8/09.  Emergency Department records received for date of service 10/8/09.  Labs and diagnostics:  CT Scan-negative. Chest x-ray-unremarkable. WBC 23,100 (H), bands 25 (H), segs 36 (L), lymphocytes 35 (NL),  Glucose 148 (H), CO2 18 (L), MPV 6.6 (L), absolute neutrophils 14.1 (H), BUN 13 (L), creatnine 0.5 (L), sodium 134 (L), anion gap 14 (H), osmolarity 271 (L), BUN/creat ratio 26 (H), CSF Culture-no growth. CSF Glucose 92 (H), CSF Total protein 14 (L).  Urine WBC 21-50 (H), Urine RBC 5-9 (H), Urine Bacteria 1+ (H).  Urine culture-over 100,000 staphlococcus aureus.	PVT	PUB		none	none. Emergency Department records received for date of service 10/8/09. PMH:  None.			1						1	Blood culture; Convulsion; Cough; Full blood count; Influenza serology; Pyrexia	FLU3~SANOFI PASTEUR~UT3179EA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0360243	10/09/2009	WA	85.0	85		F		Injection site: redness, little bruise, itching, warm.										10/07/2009	10/07/2009	0		UNK	UNK		No				1						1	Injection site erythema; Injection site haematoma; Injection site pruritus; Injection site warmth	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA276AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0360245	10/09/2009	CA	23.0	23		M	10/09/2009	About 3 days after flu shot some cold/flu symptoms began. Runny nose/sneezing. The 4th and 5th day had heavy sneezing runny nose and sore throat. 6th and 7th day felt fatigue and coughing. About seven days later I began to recover, but still had some coughing and sore throat. Cold sores on lips.									Y	10/01/2009	10/04/2009	3	None	UNK	UNK		No	N/A			1						1	Cough; Fatigue; Influenza; Nasopharyngitis; Oral herpes; Oropharyngeal pain; Rhinorrhoea; Sneezing	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97850P1~1~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360246	10/09/2009	TN	40.0	40		F	10/08/2009	After patient was given shot, chest and throat felt tight. Went to ER after 45 minutes. Was given BENADRYL and STEROID at ER had some swelling and hives.				Y					Y	10/06/2009	10/06/2009	0		OTH	PVT		None	Sulfa drugs			1						1	Chest discomfort; Swelling; Throat tightness; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360248	10/09/2009	WI	78.0	78		M		Pneumovax = Left deltoid was swollen, achy to the size of a baseball with redness originating at injection site spreading down upper arms near elbow. No treatment necessary (seen on 10-9-09).				Y					U	10/06/2009	10/07/2009	1		PVT	UNK		No	PCN; SULFA; MACROLIDES; LEVAQUIN > allergies			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U3191AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0632Y~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0360252	10/09/2009	CA	22.0	22		F	10/08/2009	Patient reports mild loss of hearing on day of vaccination, continues to persist x 6 days. Rec. PSE in case of sinus congestion.									U	09/25/2009	09/25/2009	0		OTH	PVT						1						1	Hypoacusis; Sinus congestion	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360253	10/09/2009	TX	9.0	9		F		Patient received FLUZONE 10/06/09 that evening. She had arm pain where the shot was given. She took some MOTRIN. The next morning she woke up with swelling of the upper lip, then at the office at about 9:00 AM, she developed erythematous pruritic hives on both feet. She was put on PREDNISONE and ZYRTEC for 3 days.									Y	10/06/2009	10/07/2009	1	None	PVT	UNK	MOTRIN-the evening after getting shot for arm pain from the shot	None	None			1						1	Erythema; Injection site pain; Lip swelling; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U3260AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360255	10/09/2009	KS	68.0	68		F	10/09/2009	Redness, edema, tenderness increase temp heat/cold parental steroid.									Y	10/06/2009	10/06/2009	0	CBC, CRP, CBC, PI/INR, Sed Rate	PUB	OTH	Coumadin, Atacand, Wellbutrin SR, HCTZ, MTV, Lanoxin, CA++, Protonix, Femara, Zometa, Hydrocodone, 02 @ 2L, Spiriva, Foradil, DuoNeb, Caduet, Lexapro, Omega 3 Fish Oil, B-Complex	None	Copd, HTN, Afild, Hx L Br Ca			1						1	Body temperature increased; C-reactive protein; Erythema; Feeling of body temperature change; Full blood count; International normalised ratio; Oedema; Prothrombin time; Red blood cell sedimentation rate; Tenderness	FLU3~SANOFI PASTEUR~0978X~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~43186AA~UNK~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360257	10/09/2009	CA	47.0	47		F	10/09/2009	Swelling of lymph node under right collar bone was noticed.  Neck is sore.  Injection site on right arm has a small bruise.  Appears to be given too high in the deltoid muscle.  (Not three fingers below the acromion process).									U	10/06/2009	10/08/2009	2	None	UNK	PUB	Symbicort, Nose spray, Levoxyl, Loratadine, Prosac	No	Seasonal Allergies and Reaction Airway Disease			1						1	Drug administered at inappropriate site; Injection site haematoma; Lymphadenopathy; Neck pain	FLU3~SANOFI PASTEUR~U3193AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360258	10/09/2009	MN	46.0	46		F	10/09/2009	Large redness around injection site. Lasting for an extended amount of time, (Fri. 10/09/2009) and enlarging in size & soreness.									U	10/05/2009	10/07/2009	2		PVT	UNK		no	Was in Hospital for rapid heart rate,prior to having a stress test the next day.			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLUX~UNKNOWN MANUFACTURER~~4~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~LA~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0360259	10/09/2009	TX	46.0	46		M	10/09/2009	101 degree fever, cold, shaking. Took 2 Advil. Ran 99.5 to 101 temp for about 10 hours. Was either cold or hot, changing back and forth all night. Stopped about 4am, felt ok, just tired from little sleep. Fever came back that afternoon about 3:15, it was 99.5-100.3 for several hours. Took 2 Advil, and was fine by 8:00pm, and slept well.									Y	10/06/2009	10/06/2009	0	no	UNK	PVT	paxil, simvastatin, pepcid ac	no	allergies to several grasses	none~ ()~~0.00~Patient		1						1	Fatigue; Feeling of body temperature change; Nasopharyngitis; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~~5~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360264	10/09/2009	MA	33.0	33		F	10/09/2009	Excoriated urticarial pruritic lesion R deltoid (inj site) after injection and lasting at least 2 weeks.										09/24/2009	09/25/2009	1		PVT	PUB						1						1	Excoriation; Injection site pruritus; Injection site urticaria; Skin lesion	FLU3~SANOFI PASTEUR~V30288AA~2~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360265	10/09/2009	OH	87.0	87		F	10/08/2009	Locally: itching, redness, warmth of arm overall; feeling of un-well shakiness lightheadedness.				Y						10/08/2009	10/08/2009	0		OTH	PUB						1						1	Dizziness; Erythema; Local reaction; Malaise; Pruritus; Skin warm; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960313P~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360266	10/09/2009	WI	11.0	11		M		Nausea, vomiting, stomach aches									Y	10/09/2009	10/09/2009	0		PUB	PUB	None	None	None			1						1	Abdominal pain upper; Nausea; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500687P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B03TAA~1~IM~UN~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~0535X~2~SC~UN~VARICELLA (VARIVAX)~1	USA		Influenza
0360267	10/09/2009	GA	4.0	4		M	10/09/2009	None reported by mother on 10/9/2009 at 2:30 PM.									Y	10/08/2009			None	OTH	PVT		None	None			1						1	Unevaluable event	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98434P1~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500713P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360268	10/09/2009	MN	32.0	32		F	10/09/2009	10/8/09 awakened with Rt eye and face swelling, lips and tongue swollen, tongue numbness, SOB, chest pain. Assessment noted new heart murmur, 0.3 epinephrine, DEPO-MEDROL 80 mg and started on PREDNISONE taper. 10/9/09 heart murmur reduced, no SOB, no chest pain, swelling decreased. Numb tongue continues.				Y					U	10/06/2009	10/07/2009	1	EKG	PVT	PVT	None	No	HTN			1						1	Cardiac murmur; Chest pain; Dyspnoea; Electrocardiogram; Eye swelling; Hypoaesthesia oral; Lip swelling; Swelling face; Swollen tongue	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98442P1A~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360269	10/09/2009	NY	54.0	54		F	09/24/2009	Rash on chest itching									N	09/21/2009	09/23/2009	2	None	PUB	OTH						1						1	Pruritus; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~ARLUA447BA~1~UN~RL~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0360270	10/09/2009	NY	36.0	36		F	09/24/2009	Rash on chest and ankle pain.									Y	09/21/2009	09/22/2009	1	None	PUB	UNK						1						1	Arthralgia; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA447BA~1~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0360272	10/09/2009	CA	32.0	32		M	10/09/2009	Bell's Palsy.  10/26/09:  Primary care records received for date of service 9/30/09 to 10/5/09. Dx:  Headache post Flumist, Bell's Palsy.    Assessment:  Presented one week after Flumist with c/o flu-like symptoms and HA w/o rash, fever, vomiting, photophobia, neck stiffness, nasal bleeding or facial pressure.  Given IM Toradol without relief.  Prescribed Epidrin for HA. Two weeks post Flumist presents with R facial sagging.  VSS.  Alert and oriented in NAD, normal speech, sensation and reflexes. Prescribed Acyclovir.				Y					N	09/24/2009	09/30/2009	6	10/26/09:  Primary care records received for date of service 9/30/09 to 10/5/09.  Labs and Diagnostics:  None	UNK	UNK		none	none.  10/26/09:  Primary care records received for date of service 9/30/09 to 10/5/09.  PMH:  Morbid obesity, obstructive sleep apnea, peripheral edema, atopic eczema.			1						1	Facial palsy; Headache; Hypoaesthesia oral; Influenza like illness	FLUN3~MEDIMMUNE VACCINES, INC.~500677P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500677P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Emergency room visit	Influenza
0360273	10/09/2009	VA	9.0	9		F	10/09/2009	swelling and shortness of breath									Y	10/08/2009	10/09/2009	1		PVT	PUB		none	asthma			1						1	Dyspnoea; Swelling	FLU3~SANOFI PASTEUR~U3216AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360274	10/09/2009	NC	54.0	54		M	10/09/2009	20min after flu shot, itching, swelling and sunburn rash.  Started with ears, face, then upper extremities.  Dermal reaction.				Y					Y	09/29/2009	09/29/2009	0		PUB	PVT		none	unknown			1						1	Pruritus; Rash; Skin reaction; Swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA482BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0360276	10/09/2009	NM	46.0	46		F	10/09/2009	Extreme aches and soreness. Was cold even though house was very warm.  Had a hard time sleeping; breathing in short breaths.  Took Advil, and was able to sleep through the night.									Y	10/08/2009	10/08/2009	0	None, feeling better today, just ache.	PUB	PVT	Both vaccinations were on left arm about 1 inch apart.  I had never had either before.	none	none			1						1	Dyspnoea; Feeling cold; Insomnia; Pain	FLUX~UNKNOWN MANUFACTURER~~1~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360278	10/09/2009	MI	36.0	36		M	10/09/2009	Rash on head and chest with pruitus									U	10/08/2009	10/08/2009	0		PVT	PVT		no	NASH	rash~Influenza (Seasonal) (no brand name)~UN~35.00~Patient		1						1	Pruritus; Rash	FLU3~CSL LIMITED~AFLUA456AA~3~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360279	10/09/2009	AL	5.0	5		M	10/09/2009	My child complained of his arm hurting that night after receiving the Flu shot, the next morning his entire bisep was swollen and warm, the next day his whole arm was swollen, he had no fever...this swelling was not local, his entire arm was swollen, it appears to be resolving now.									U	10/05/2009	10/06/2009	1		PVT	UNK		No				1						1	Oedema peripheral; Pain in extremity; Skin warm	FLUX~UNKNOWN MANUFACTURER~~5~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360280	10/09/2009	IN	7.0	7		M	10/09/2009	Swelling at knee joint on the leg the vaccine was injected into.  The swelling WAS NOT at the injection site.  ONLY at the joint.				Y					Y	09/23/2009	09/24/2009	1		UNK	UNK	Nasonex, Allegra	No	Seasonal Allergies, Asthma			1						1	Joint swelling	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360281	10/09/2009	NY	22.0	22		F	10/09/2009	1st 30 min: redness in face, pounding head went to CVS in Cohoes (where administered) to check on results. Heart Rate (HR) 125. Redness continued to worsen, they called 911. HR was 135 when EMS arrived. Took to ER. 30-60min (ambulance): HR about 140, was given Benadryl to ease symptoms. Almost vomited. given an IV. shaking started as soon as we arrived at the ER - compulsive, teeth shattering. 60-120min (ER): HR stayed at 140, was given prednisdone. redness had spread to my entire body, except hands/feet. 120-150min: completely red, but shaking stopped. 2 1/2 hrs-5hrs: HR dropped to about 115, redness was going down. discharged from hopsital approx 10:30 PM. Next day: face still red, HR back to normal. Followed up with doctors 11/5/2009 ED record for 10/8/2009, patient with c/o's rash, palpitations, swelling, difficulty breathing. TX: Benadryl and Zofran with sx resolution. DC DX: allergic reaction				Y					Y	10/08/2009	10/08/2009	0	Symptoms going away 24 hours later Going to have a skin test done to check for allergies to components of vaccines Labs: none noted Dx studies: EKG sinus tach	UNK	UNK	Allegra (180mg daily) Lexapro (20mg daily)	No	Seasonal Allergies PMH: Anxiety Allergies: Zyrtec			1						1	Chills; Erythema; Headache; Heart rate increased; Nausea; Skin test; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97849P1~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360282	10/09/2009	IN	5.0	5		F	10/09/2009	Child developed rash with hives & itching that began on torso and spread to extremities				Y					Y	10/03/2009	10/03/2009	0		PUB	PUB		None	None			1						1	Pruritus; Rash; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500717P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0360284	10/09/2009	OH	55.0	55		F	10/09/2009	Pt called with question on possible side effect to vaccine. Reports tenderness at injection site for 4-5 days after vaccine.She then traveled and slept in hotel overnight and woke with more pain down arm and muscles continued soreness around left shoulder and bicep area. Some improvement but almost 2 wks out and symptoms/muscle soreness not gone.									U	09/28/2009	10/03/2009	5		PUB	UNK	none noted	none noted	none noted			1						1	Injection site pain; Musculoskeletal pain; Myalgia; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960342P~UNK~~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360285	10/09/2009	WI	41.0	41		F	10/09/2009	severe pain under arm pit, lymph nodes extending into breast				Y					Y	10/06/2009	10/07/2009	1	Reaction from flu shot per physician	UNK	PVT		NO	None			1						1	Breast pain; Immunisation reaction; Lymph node pain; Pain	FLU3~SANOFI PASTEUR~U3193~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360286	10/09/2009	MT	34.0	34		F	10/09/2009	Within 15 minutes of administration arm felt heavy, like it was asleep.  Within 1 hour tongue felt swollen, no difficulty swallowing or breathing.  Given 50mg of liquid Benadryl with symptoms resolved in 15 minutes.									Y	10/09/2009	10/09/2009	0		PVT	PVT		no	none			1						1	Sensation of heaviness; Swollen tongue	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua458ba~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0360287	10/09/2009	KS	56.0	56		F	10/09/2009	redness,hot to the touch Dr from a walk in health prescribed doxy 100mg 1 bid									Y	10/06/2009	10/08/2009	2		UNK	UNK		no	no			1						1	Erythema; Skin warm	FLU3~SANOFI PASTEUR~u3187aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0627y~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360288	10/09/2009	OR	3.0	3		F	10/09/2009	103.6 degree F fever										10/08/2009	10/09/2009	1		UNK	UNK		None	None			1						1	Pyrexia	FLU3~SANOFI PASTEUR~U3260DA~5~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~5007751P~1~~~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA		Influenza
0360290	10/09/2009	CA	29.0	29		F	10/09/2009	Both my husband and I got a flu shot and a tetanus shot in our left arms.  Both of us experienced severe aching, which we expected.  His went away after about 2-3 days.  Mine got slightly better, then got worse, until I could barely move my arm, and certainly not without pain.  My arm became red, itchy and so swollen that beyond where I could move my arm without pain, there was a lot of lost mobility where it was impossible to move my arm because of how swollen it was.  When I tried, even with pain, it would be like I had a physical barrier blocking my arm.  Also, it occasionally felt like a burning sensation in my arm, and it was certainly warm/hot to the touch.  As well as hurting to move, it also hurts to touch my arm. It has been a week now, and I am on antibiotics, but it is currently only slightly better.  I have difficulty sleeping, am unable to sleep on my left side, and I can barely move my left arm.  My husband actually has to help me with changing my clothing, it is so bad.									U	10/02/2009	10/02/2009	0		PVT	UNK	Advair, generic flonase, orthotricyclen Lo (generic)	No.	Asthma, ecsema, general topical skin allergies (dust mites, grass, weeds, pollen, cat dander, shellfish/tactile only), post nasal drip			1						1	Burning sensation; Erythema; Insomnia; Mobility decreased; Oedema peripheral; Pain; Pruritus; Skin warm	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|TDAP~SANOFI PASTEUR~~UNK~~~TDAP (ADACEL)~1	USA		Influenza
0360291	10/09/2009	MO	22.0	22		M	10/09/2009	General fatigue, body aches, feeling of fever (however none), nasal congestion, headache, sore throat, cough, lung congestion, and depressed mood.									Y	10/07/2009	10/08/2009	1		UNK	UNK		No	None			1						1	Depressed mood; Fatigue; Feeling hot; Headache; Nasal congestion; Oropharyngeal pain; Pain; Pulmonary congestion	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500763P~1~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA		Influenza
0360292	10/09/2009	TX	68.0	68		F	10/09/2009	Erythema of upper right arm, fever, chills, lymphadenopathy.  Treated with Bactrim DS 1 tablet 2 times a day for 10 days. Follow up with Dr. on 10-9-09.				Y					U	10/05/2009	10/05/2009	0		UNK	UNK	unknown	none	none noted			1						1	Chills; Injection site erythema; Lymphadenopathy; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA257AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~1296X~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0360296	10/09/2009	AZ	34.0	34		F	10/09/2009	Myalgias, subjective fever, nausea/vomiting, dehydration.				Y						10/08/2009	10/08/2009	0	CBC, CMP, UA, pregnancy test--significant for Na 126; anion gap of 17; bili 3.6 (up from 3.1); chronic anemia and thrombocytopenia	UNK	UNK	Lasix, spironolactone Note: the Hep B, Pneumo and DTap were administered at Dr. office, the patient's PCP		NASH--nonalcoholic steatohepatitis, on the liver transplant list			1						1	Anion gap increased; Blood bilirubin increased; Blood sodium decreased; Dehydration; Full blood count; Metabolic function test; Myalgia; Nausea; Pregnancy test; Pyrexia; Urine analysis; Vomiting	FLUX~SANOFI PASTEUR~~UNK~~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360334	10/09/2009	TX	88.0	88		F	10/09/2009	Guillain Barre syndrome (LE Weakness, numbness and tingling in extremities, severe back pain). TX: IV Ig.    10/23/09:  Hospital Records and Discharge Summary received for dates of service 9/28/09 to 10/14/09.  GBS, Severe back pain, UTI, Hypokalemia, Hyponatremia, Constipation, Syncope, Left humeral fractures, Accelerated HTN, PVD, Dyslipidemia, Osteoporosis with degenerative joint disease and disk disease, Anxiety. Assessment:  Presented with severe abdominal and back pain (8/10) after syncope episode.  Had some nausea and vomiting 36 hours prior to admission.  Patient fell recently and had left humeral fractures.  C/o numbness and tingling in LE's and UE's and significant pain not well controlled by meds as well as LE weakness.  Neuro consult & LP done. IVIG started for 5 days with slight improvement in motor function and motor strength.  Placed on a fentanyl patch and morhpine sulfate for back and hip pain.   UTI was treated which reduced pelvic and hip pain. Had trouble swallowing and and NG Tube was placed but pt. began gurgling up with NG tube, so a PEG tube was placed.   Blood pressure fluctuated throughout LOS, thought to be due to vasormotor instability secondary to GBS.   Discharged to long term care facility.							Y			09/21/2009	09/25/2009	4	CSF (protein, cell count, stain, culture); EMG.    10/23/09:  Hospital Records and Discharge Summary received for dates of service 9/28/09 to 10/14/09.  Labs and Diagnostics:  CSF: protein 68(H), glucose 59(N), c/s neg.  EMG/NCS abnormal.  CT Scan abdomen-possible mass at tail of pancreas.  EUS-no pancreatic mass, common bile duct dilation and sludging of the gallbladder.  Spinal x-ray-moderate degenerative changes of the lumbar.  CT Thorax-calcified arthrosclerotic plaque.  Hip X-rays-mild hip osteoarthritis.  CT of Head-no acute intercranial abnormalities.  MRI of neck, thorax and lumbar-significant degenerative joints and some mild to moderate central canal stenosis.  KUB of abdomen-no obstructions.  Glucose 134 (H), AST 49 (H).  UA 2+ leukocyte esterase, few bacteria, 3-9 WBC's (H).	OTH	OTH		HTN; left humeral fracture; PVD; DJD	Allergy  to codeine (nausea / vomiting - SE). 10/23/09:  Hospital Records and Discharge Summary received for dates of service 9/28/09 to 10/14/09. PMH:  COPD, HTN, Hyperlipidemia, Osteoporosis, PVD, Obstructive sleep apnea, Osteopenia, Degenerative joint disease, Anxiety disorder, Tonsilectomy, Left and Right Cateract repairs, R breast cyst removal, Hemorrhoidectomy, Dental surgery.  NKDA.			1						1	Back pain; Blood product transfusion; CSF cell count; Gram stain; Guillain-Barre syndrome; Hypoaesthesia; Muscular weakness; Paraesthesia	FLU3~CSL LIMITED~01449211A~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Hospitalisation	Influenza
0360335	10/09/2009	VA	31.0	31		F	10/08/2009	Patient given flu shot (seasonal) at 11:00 a.m. and approx 20 mins later developed flushing hives. Never any development of respiratory sx or anaphylaxis. Treatment consisted of patient monitoring admin of oral antihistamine and IM SOLUMEDROL.				Y					Y	10/07/2009	10/07/2009	0	BP and pulse normal pulse ox 98% normal	PUB	OTH	CONCENTRA; SYNTHROID; FLEXERIL; DARVON; DIFLOFENAC	None	ADD; HD; hypothyroidism; lower back pain; allergy:PCN			1						1	Flushing; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA462A~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0360336	10/09/2009	VA	12.0	12		M	10/09/2009	Onset on September 5, two days post vaccination of new form of seizures, with low grade fevers (to 102.5), dark brown urine, protein urine and hematuria, tachycardia (100) and yellow skin. Intractable seizures admitted x20 day so far.   10/29/2009 hospital records from multiple admissions 9/15-10/16/2009. Patient with sx of fever, tonic/clonic seizures, sore throat, dark urine, tacchycardia, cervical lymphadenopathy. Initially seen at PCP and tx'd for strep throat as rapid strep test was + although culture was negative. Sx progressed to tonic/clonic seizure activity of bilateral UE's up to 15 x a day. Patient evaluated per Pediatric Neurology.  10/30/09  Emergency Room records received for date of service 9/10/09.   Dx:  New onset Myoclonic Seizures, hematuria Assessment:  Presented to ED after 15 seizures a day over two days with gross hematuria that started two days prior.  Denied dysuria, abd. pain, polyuria, frequency or urgency.  Treated with Ativan.  Discharged to home in stable condition.   10/30/09 Discharge Summary and Medical Records received for dates of service 9/22/09 to 10/8/09.  Dx:  Myoclonic Seizure disorder, history of nephrolithasis secondary to hypocitraturia and hypercalcuria, gross hematuria, developmental delay including speech delay, scoliosis, growth hormone deficiency, failure to thrive, hypothyroidism, constipation.  Assessment:  Since having his flu shot, this child who has been maintained seizure free for two years on Keppra and a ketogenic diet had experienced tonic clonic activity, fevers and dark colored urine.  Presented for this hospitlalization after experiencing an apneic event which required for to five rescue breaths.  EEG was abnormal and pt. admitted.  Afebrile throughout stay with no evidence of rash.  Ketogenic diet was maintained.  New episode of hematuria with normal renal function, nromal blood pressure and no evidence of fluid retention. Hemoglobin remained stable during inpatient stay ranging from 12.5 o 13.3.   Electrolytes remained WNL.  Stable on room air. Transferred.    10/30/09 ICD 9 Codes Received:  345.11, 599.70, 783.40, 783.41, 244.9, 253.3, 315.39, 592.0, 737.30./rmc					Y	30			N	09/03/2009	09/05/2009	2	Labs and lumbar puncture negative for infection, MRI of brain normal. 10/29/2009 hospital records from multiple admissions 9/15-10/16/2009 Labs: UA + blood, 3+ protein, ASO titer neg, C3 neg, CK neg Dx studies: Ct abdomen noted a known renal stone 10/30/09  Emergency Room records received for date of service 9/10/09.Labs and Diagnostics:  6 mm stone in left renal pelvis.   10/30/09 Discharge Summary and Medical Records received for dates of service 9/22/09 to 10/8/09.  Labs and Diagnostics:  MRI and MRA of brain-unremarkable.  EEG Abnormal. TSH 0.28 (L), T4 0.74 (L). WBC 3.4 (L), Mono % 12.0 (H), Eos % 3.5 (H), Urine Ketones >=160 (H), Urine Blood Moderate (H), Urine Mucous Moderate (H).	PVT	UNK		None	Development and growth delay; Myoclonic seizures had largely resolved 10/29/2009 hospital records from multiple admissions 9/15-10/16/2009.  PMH: Myoclonic epilepsy and developmental delay Allergies: NKDA 10/30/09  Emergency Room records received for date of service 9/10/09. PMH:  Genetic syndrome, encephalopathy, seizure disorder, r/o kidney stones.  10/30/09 Discharge Summary and Medical Records received for dates of service 9/22/09 to 10/8/09.  PMH:  As above.	Fever~Hep B (no brand name)~3~1.00~Patient		1						1	Chromaturia; Convulsion; Epilepsy; Haematuria; Laboratory test normal; Lumbar puncture normal; Nuclear magnetic resonance imaging brain normal; Protein urine present; Pyrexia; Tachycardia; Yellow skin; Condition aggravated; Convulsion; Glomerulonephritis	FLU3~SANOFI PASTEUR~U3259EH~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U3259EH~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Hospitalisation	Influenza
0360340	10/09/2009	ME	9.0	9		F	10/09/2009	Pt had low grade temp 99.5 prior to vaccination with no c/o illness, or SB /c/o - Very shortly after vaccination pt c/o dizziness which persisted. EMS on site decided to transport pt to ED. While in ED pt received hydration & at one point had decreased level of verbal response. Pt remained in hospital for observation for about 24 hrs. Hospital course uneventful, pt's only c/o was vertigo & headache. Physician felt patient had concurrrent viral illness and SB, not vaccine related. 10/26/2009 hospital records for date 10/8/2009. Patient presents with sx of dizziness,lightheadedness, nausea, decreased responsiveness, paleness and somnolence. PE normal, admitted for observation.  DC DX; Adverse reaction to flu shot, viral syndrome.     current viral illness and SB - not vaccine related.				Y	Y	1			Y	10/08/2009	10/08/2009	0	Transitory elevation of liver enzymes; CBC, WNL Labs: CBC, CMP, AST 65 high, ALT 78 high, stool cultures neg, Hepatitis panel neg DX tests: EKG WNL	OTH	PUB	None	Low grade temp	Hives with PCN - Allergy PMH: None Allergies: PCN			1						1	Body temperature increased; Dizziness; Full blood count normal; Headache; Hepatic enzyme increased; Unresponsive to stimuli; Vertigo; Viral infection	FLUX~SANOFI PASTEUR~U3178BA~UNK~IJ~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0360341	10/09/2009	MA	1.23	1	.2	F	10/05/2009	Atypical febrile seizure. 12/8/2009 DC summary for 10/3-10/5/2009, patient with 1 week hx of fever, also runny nose and loose stools, had new onset seizure activity with tonic-clonic movements, cyanosis and lethargy. LP done, IV ABX					Y	2			Y	10/02/2009	10/03/2009	1	CBC, WNL; Urine; CSF and Bld cultures all negative; MRI/MRA, NL; Lumbar puncture, unconcerning for infection  Labs: CBC, Platelet ct low, csf ct normla, blood, urine and csf culture negative, Herpes PCR, Influenza AB test Dx stuides: MRI/MRA brain wnl, EEG results pending at time of discharge	PVT	PUB		Mild	PMH: None Allergies: NKDA			1						1	Blood culture negative; CSF culture negative; Culture urine negative; Febrile convulsion; Full blood count normal; Lumbar puncture normal	DTAPIPVHIB~SANOFI PASTEUR~C3152AA~4~IM~LL~DTAP + IPV + HIB (PENTACEL)~1|FLU3~SANOFI PASTEUR~U3262EA~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~D48929~4~IM~RL~PNEUMO (PREVNAR)~1	USA	Hospitalisation	Influenza
0360346	10/09/2009	MA	5.0	5		F	10/09/2009	Fever 101 10/8/09 during night followed by vomiting early AM 10/9/09; vomiting every hour. Also with nasal congestion, runny nose, sore throat and headache. Vomiting, running nose, fever, headache, congestion during doctors visit. Sunday 10/11- rash all over body and strep throat and fever.				Y					U	10/08/2009	10/09/2009	1		PVT	PVT	Antibiotics	No	No			1						1	Headache; Nasal congestion; Oropharyngeal pain; Pharyngitis streptococcal; Pyrexia; Rash generalised; Rhinorrhoea; Vomiting	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500754P~1~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA	Emergency room visit	Influenza
0360347	10/09/2009	IN	35.0	35		F		Left arm swelling similar to large localized reaction. Resulted in viral syndrome and dehydration. Admitted for IV therapy fluids. 10/19/09 Discharge summary received for dates 10/6/09 to 10/7/09. DC DX: viral syndrome, dehydration, reaction to fluzone. SX: c/o HA, cough x3 days, night sweats, fever, nausea, myalgias, arthralgia. Assessment: pt. was treated one day ago by outpatient with IV therapy/hydration. Pt. did not improve. Admitted for further treatment and supportive care. Pt. dc home 24hrs later improved condition.					Y	1			Y	10/03/2009	10/05/2009	2	10/19/09 Discharge summary received for dates 10/6/09 to 10/7/09. Diagnostics/Lab: CXR(-), blood culture(-), MRSA culture(-), WBC 12.3(H), band % 12(H), Lymphocytes % 6(L), absolute neutrophils 11.2(H).	PVT	PVT	Vivelle patch	None	None; Smoker 10/19/09 Discharge summary received for dates 10/6/09 to 10/7/09. PMH: smoker, panic disorder, anxiety, allergic rhinitis.			1						1	Dehydration; Local reaction; Oedema peripheral; Viral infection	FLU3~SANOFI PASTEUR~U3203AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0632Y~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0360350	10/09/2009	CA	93.0	93		M	10/06/2009	Pt refused to wait 15 mins. after vaccination as he had flu vaccine before. While walking out of store he fell backward and hit his head near store entrance. His head was bleeding but was aware of situation. Store manager called 911 and paramedics took him to hospital.				Y					U	10/06/2009	10/06/2009	0	None	OTH	PUB	diltiazem; levothyroxine; FLOMAX	None	High blood pressure; thyroid disorder; BHP			1						1	Fall; Haemorrhage; Head injury	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97843P2~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360351	10/09/2009	TX	31.0	31		F	10/10/2009	Headache, diarrhea, fever 103.				Y					U	10/07/2009	10/07/2009	0		PVT	OTH	Sulfamethoxazole	Skin/soft tissue infection	N/A			1						1	Diarrhoea; Headache; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360352	10/09/2009	MO	78.0	78		M	09/14/2009	Rash - red flat patch on upper chest 24 hours after administration of INFLUENZA and ZOSTER vaccines. Treated with BENADRYL po.									Y	09/13/2009	09/14/2009	1		PVT	PVT	FLOMAX; ASA, SPIRONOLACTOR; SIMVASTATIN; LISINOPRIL; DIGOXIN	None	High blood pressure; High cholesterol; BPH			1						1	Erythema; Rash macular	FLU3~SANOFI PASTEUR~U3191AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~07459~1~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0360355	10/09/2009	WA	55.0	55		F	10/08/2009	Rt. arm swollen, hot, itchy. Physician diagnosed staph infection and cellulitis on 10/9/09,				Y					Y	10/06/2009	10/07/2009	1		OTH	PUB						1						1	Cellulitis; Oedema peripheral; Pruritus; Skin warm; Staphylococcal infection	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98441P1~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1296X~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0360358	10/09/2009	OH	64.0	64		M	10/05/2009	Red, swollen, tender right arm, fever, sweating									U	10/03/2009	10/03/2009	0		OTH	OTH	None	None	None			1						1	Hyperhidrosis; Injection site erythema; Injection site pain; Injection site swelling; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0627Y~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360359	10/09/2009	KY	69.0	69		F	10/09/2009	10-5-09 Pt rec'd flu vaccine in left deltoid 10-8-09 Pt called clinic due to itching and redness. NP told her to take BENADRYL. Today 10/9/09 Pt went to PCP and he gave her a MEDROL DOSE PACK.				Y					U	10/05/2009	10/08/2009	3		OTH	OTH	CELEBREX; VYTORIN; CITALOPRAM; FOSAMAX; SPIRONOLACTONE	none	None			1						1	Erythema; Pruritus	FLU3~SANOFI PASTEUR~U3214AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360360	10/09/2009	TN	30.0	30		F	10/09/2009	10-8-09 - slight redness at inj site. Dizziness x 2 hr. Contact MD - Advised keep watch & come to MD office if problems continue 10-9-09 - inj site more red, well defined with edema 3 diam. slight itchy, hot, sore.									Y	10/07/2009	10/08/2009	1		OTH	PVT	None	None				1						1	Dizziness; Injection site erythema; Injection site oedema; Injection site pain; Injection site pruritus; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P1~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360361	10/09/2009	TX	2.0	2	.1	M	10/09/2009	Increase in baseline wheezes + urticaria									Y	10/09/2009	10/09/2009	0	Strep screen negative	PVT	PUB	ALBUTEROL NEB	AGE/URI/wheezing	AMOXICILLIN			1						1	Streptococcal identification test negative; Urticaria; Wheezing	FLU3~SANOFI PASTEUR~U3174BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360362	10/09/2009	NV	44.0	44		F	10/06/2009	Diffuse itching and mild rash. Given BENADRYL orally.									Y	10/06/2009	10/06/2009	0		PUB	UNK		No	Sulfa allergy			1						1	Pruritus; Rash	FLU3~SANOFI PASTEUR~U3201AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360363	10/09/2009	TX	23.0	23		F	10/09/2009	Started with Flu like symptoms - fever, weakness, earache, tingling of tongue - then 2 days later - eye twitching - then HA; neck pain and eye twitching  - left sided facial weakness-paralysis. Progress recovering.  12/9/09PCP records rec'd for DOS 9/29/09 with dx:  Bell's Palsy.  Pt presented with 5 day hx of L-sided facial numbness/weakness. Also c/o L-sided earache, neck pain and frontal h/a.  Dizziness 2' to eyepatching. PE (+) for L facial droop with decreased sensation, otherwise neuro exam WNL with normal strength in upper and lower extremities. Tx: Pred and Acyclovir.				Y					U	09/18/2009	09/20/2009	2		MIL	OTH		None	None PMH: NKDA			1						1	Ear pain; Influenza like illness; Muscle twitching; Neck pain; Paraesthesia oral; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA456BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0360364	10/09/2009	FL	45.0	45		F	10/07/2009	Trouble breathing, chest tightness, diarrhea, nausea, approximately 12 to 24 hours after flu shot administration hives, fever up to 103, O2 sat decreased.				Y						09/24/2009	09/25/2009	1		OTH	PVT		Pt on antibiotic (1st time on med)				1						1	Chest discomfort; Diarrhoea; Dyspnoea; Nausea; Oxygen saturation decreased; Pyrexia; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97844P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360366	10/09/2009	WA	55.0	55		M	10/09/2009	Fever, muscle pain at injection, Corporal tunnel R wrist inflamed spleen, inflamed intestines, diaherra 2 times day, impaired speech motor movements, trouble with words, mercury poison, home treated w/natural antibiotics, sugar level off, fruity breathe slight fever, hotness impaired speech motor movements.  12/3/09 Medical records receoved for DOS 9/28/09. C/O LUQ pain x1 week. intirraermittent/burning radiates to R upper abdomen. Diarrhea.				Y					Y	09/08/2009	09/09/2009	1	Lab, blood test, suspect urine showed sugar - elevated sugar. Electrolyte not being normal.  Labs & Diags: glucose 130 (H)	OTH	UNK	None	No	No  Allergies: teteanus antitoxin			1						1	Aphasia; Blood glucose abnormal; Breath odour; Carpal tunnel syndrome; Diarrhoea; Electrolyte imbalance; Feeling hot; Gastrointestinal disorder; Glucose urine; Inflammation; Injection site pain; Metal poisoning; Motor dysfunction; Pyrexia; Speech disorder; Spleen disorder; Aphasia; Blood glucose increased; Body temperature decreased; Carpal tunnel syndrome; Chills; Diarrhoea; Myalgia; Nerve injury; Pain in extremity; Pyrexia; Skin warm; Splenomegaly	FLU3~SANOFI PASTEUR~U3167EA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|FLU3~SANOFI PASTEUR~U3167EH~UNK~IJ~RA~INFLUENZA (SEASONAL) (FLUZONE)~2	USA	Emergency room visit	Influenza
0360367	10/09/2009	NY	15.0	15		M	10/09/2009	Patient received his injectable influenza vaccine at about 5:25 pm today at the medical office. He was sitting at the examining table.				Y					Y	10/09/2009	10/09/2009	0		UNK	UNK	None	None	Allergy to Sulfa drugs			1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U3178BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360368	10/09/2009	IL	72.0	72		F	10/09/2009	Weak, dizzy, pain in the arm where shot was given, a red spot formed on the arm temp - 102.0.									U	10/07/2009	10/08/2009	1	None	PUB	PUB	Advil & Lovastatin	None	Cholestrol			1						1	Asthenia; Body temperature increased; Dizziness; Erythema; Injection site pain	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0360370	10/09/2009	MI	52.0	52		F	10/08/2009	Headache, scratchy throat, flushed face felt puffy and swollen and red. Pain down arm and up into shoulder. MOTRIN - event lasted 48 hours.									Y	10/01/2009	10/01/2009	0	None	PUB	PVT	WELLBUTRIN; INDERAL; DETROL; ASPIRIN	None	Allergies - DEPAKOTE, migraines			1						1	Erythema; Flushing; Headache; Musculoskeletal pain; Pain in extremity; Swelling face; Throat irritation	FLU3~CSL LIMITED~08549111A~UNK~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360372	10/09/2009	AL	51.0	81		M	10/09/2009	C/O bones aching next day pain, progressing to worse, severe headache, shivering, had bones aching and temp 10/7. Bones aching this a.m.				Y					N	09/24/2009	09/25/2009	1		OTH	OTH	ASA (Chlorzox AZA)	None	a - fib, enlarge prostate			1						1	Body temperature increased; Bone pain; Chills; Headache; Blood test; Body temperature increased; Bone pain; Chills; Computerised tomogram; Headache; Influenza serology	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA447CA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFlUA447CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA	Emergency room visit	Influenza
0360373	10/09/2009	MO	48.0	48		F	10/09/2009	Lymph nodes under left arm swelled 36 hours after inj-pain and lumped-fever low grade. Trouble concentration-supraclavicle nodes swollen.				Y					Y	10/05/2009	10/06/2009	1	X-rays of chest and shoulder-CBC	PUB	PVT		None	HTN; gen. anxiety disorder; chronic pain disorder; potassium def.			1						1	Chest X-ray; Disturbance in attention; Full blood count; Injection site pain; Lymphadenopathy; Pyrexia; X-ray	FLU3~SANOFI PASTEUR~U3193AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360374	10/09/2009	CA	58.0			U		Patient felt very dizzy.									Y					OTH	PUB						1						1	Dizziness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2A~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360375	10/09/2009	IL	21.0	21		F	10/07/2009	Called with arm pain, Patient went to doctor. Doctor states the injection was not deep enough and that caused the discomfort.									Y	10/07/2009	10/07/2009	0	None	PUB	PVT	LEXOPIN; AZURETTE	None	None			1						1	Injection site pain; Wrong technique in drug usage process	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848P1C~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360376	10/09/2009	CA	73.0	73		F		Pt started to feel itchiness on the upper body. Pt cx of feeling thirsty and had a drink of water before I was informed. Pt also cx of HA. We asked pt to wait for some more to observe her symptoms. Pt declined ambulance service said she did not want to go to ER. If later on she needs it, her family will take her. Pt wanted to go home to rest.									U	10/09/2009	10/09/2009	0		UNK	UNK						1						1	Headache; Pruritus; Thirst	FLU3~CSL LIMITED~0549111A~UNK~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360379	10/09/2009	OH	83.0	83		F	10/09/2009	R sore, swollen, redness, blisters-last nite, gone today itching, -in area near the shot - extra strength tynenol.									N	10/08/2009	10/08/2009	0	None	PUB	PVT	Fluticasone, Gabapentin, Timolol, Azopt, Miralax, Loratidine, Lumigen,	Seasonal Allergies - Osteoarthritis - stable	Osteoarthritis, Refle Gerd			1						1	Injection site erythema; Injection site pain; Injection site pruritus; Injection site vesicles	FLU3~GLAXOSMITHKLINE BIOLOGICALS~0870X~UNK~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~~UNK~~~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360300	10/10/2009	MO	49.0	49		M	10/10/2009	severe neuropathic radiculitis, lumbo-ischialgia									N	10/07/2009	10/08/2009	1		UNK	UNK		no	Latex allergy, pollen allergy			1						1	Radiculitis; Sciatica	FLUX~SANOFI PASTEUR~UT3175BA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360301	10/10/2009	IN	38.0	38		F	10/10/2009	Member said she recieved the flu mist on Saturday and started feeling symptoms on Sunday.  She claims the symptoms persisted all month and then reported back to our unit on the 3rd of October.  She has been seen but we have yet to hear the results of her PCM visit.				Y					U	09/12/2009	09/13/2009	1	NONE AT THIS TIME.	MIL	MIL		Member denies any illnesses at the time she recieved the flu mist	None recorded			1						1	Influenza like illness	FLUN3~MEDIMMUNE VACCINES, INC.~500711P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0360302	10/10/2009	AR	54.0	54		F	10/10/2009	Started with general aches, developed gradually into cough, hoarseness, soreness to injection site w/ whelped area at site, generalized light rash, low grade fever, generalized itching, watery eyes, then developed into SOB. That was on Wed, then progressed so by Monday, developed into Pneumonia, was off work for total of 5 days.									Y	09/23/2009	09/23/2009	0	none	UNK	UNK		no symptoms of illness prior to vaccination	DMII, asthma, NKDA.			1						1	Activities of daily living impaired; Cough; Dysphonia; Dyspnoea; Injection site pain; Injection site urticaria; Lacrimation increased; Pain; Pneumonia; Pruritus generalised; Pyrexia; Rash generalised	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360305	10/10/2009	FL	67.0	67		F	10/10/2009	I developed vertigo, dizziness and a headache. I went to urgent care on 9/26/09 and received Antivert. I went back to urgent care on 9/28 bacause of persistent symptoms. The symptoms finally resolved on 10/7/09				Y					Y	09/23/2009	09/24/2009	1	EKG, CBC and head CT. the CBC and EKG was normal	UNK	PUB	zetia, rhinocort AQ, calcium, fish oil, asa, vitamin	none	allergy to sulfa and penicillin			1						1	Computerised tomogram; Dizziness; Electrocardiogram normal; Full blood count normal; Headache; Vertigo	FLUX~SANOFI PASTEUR~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360307	10/10/2009	MD	27.0	27		F	10/10/2009	Inspiratory and expiratory wheezing, headache, red eyes and fever until 01:00 PM the folowing day										09/10/2009	09/10/2009	0		PUB	PVT		uti				1						1	Headache; Ocular hyperaemia; Pyrexia; Wheezing	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360308	10/10/2009	CA	79.0	79		F	10/10/2009	PATIENT WALK IN AT THE CLINIC TODAY REPORTED NOTED REDNESS ON RIGHT ARM BELOW  WHERE THE SHOT WAS GIVEN YESTERDAY PATIENT DID NOT REPORT TO PROVIDER IMMEDIATELY THINKING IT WILL GO AWAY.  RN NOTED REDNESS ON RIGHT ARM 5 FINGERS BELOW  FROM THE INJECTION SITE. FEELING WARMTH TO TOUCH. NO HARD LUMP NOTED, PATIENT DENIES SORENESS OR PAIN. AFEBRILE. DENIES DYSPNEA, DENIES CHEST PAIN, DENIES TIGHTNESS ON THROAT.				Y					U	10/08/2009	10/09/2009	1		MIL	MIL	COUMADIN, ADALAT, MULTIPLE VITAMINS, CELEXA (PT STOPPED X 1 WEEK); ATENOLOL, DETROL LA.	PATIENT SUBJECTIVE COMPLAINT WAS HAD BEEN FEELING TIRED LATELY AND WAS SEEN FOR F/U ER VISIT.	HYPERTENSION, DEPRESSION, STROKE ON COUMADIN THERAPY			1						1	Injection site erythema; Injection site warmth	FLUX~SANOFI PASTEUR~UT3172AA~2~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0867X~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0360311	10/10/2009	MA	66.0	66		M	10/10/2009	Severe muscle pain, almost debilitating				Y						09/28/2009	09/29/2009	1	Dr. prescribed Naproxen 500 MG, 2 per day for 20 days. So far some help. Also went to an Acupuncture Doctor for treatment for relief of muscle pain.	UNK	UNK		No	None			1						1	Myalgia	FLU3~CSL LIMITED~~UNK~~~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0360312	10/10/2009	ND	6.0	6		F	10/10/2009	sore throat, fever, cough - gave tylenol and cough syrup, by 5:00 pm she was running a high fever and the tylenol would break it and the fever kept coming back until 10/10/09 about 11:00 AM fever finally broke.									Y	10/08/2009	10/09/2009	1		PUB	PVT		no	allergies			1						1	Cough; Oropharyngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360313	10/10/2009	MN	36.0	36		F	10/10/2009	fever of 102 degrees with severe chills, abd pain, weakness. Fever subsided after tylenol and ibuprofen dose. weak for 24 hours following. No other symptoms of illness.									Y	10/07/2009	10/08/2009	1		UNK	UNK		no	diabetes type I			1						1	Abdominal pain; Asthenia; Chills; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360315	10/10/2009	CA	51.0	51		M	10/10/2009	patient with onset of body aches, rash and diarrhea. Patient called 911, and given diphenhydrmine injection in ambulance which resulting in resolution of rash by the time patient arrived at the ED									Y	09/29/2009	10/02/2009	3	None	PUB	PUB		No	Diabetes			1						1	Diarrhoea; Pain; Rash	FLUX~SANOFI PASTEUR~U3193AA~2~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~1163X~1~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360316	10/10/2009	VA	30.0	30		F	10/10/2009	Pt says she has pain in the entire arm the vaccine was given. She says it started after the vaccination and it still hurts when she moves it. Pt saw her physician and was given Naproxen 500mg for pain. The incident was reported to VA on 10.10.2009				Y					N	09/25/2009	09/25/2009	0		UNK	PVT		Unknown	Unknown		VA	1						1	Injection site pain; Pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838p1~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360317	10/10/2009	PA	62.0	62		M	10/10/2009	Extreme shaking chills.  Significant soreness/pain in arm of injection.  Difficulty moving arm.  11/30/09 DOS 11/20/09   Final DX: Rhabdomyolysis and presumed postviral myositis.  On 11/19/09, Pt c/o lower leg pain bilaterally, swelling and macular rash. On examination: bilateral edema with tenderness to deep palpation below the knees bilaterally. Pt developed difficulty urinating, inability to walk due to the LE pain.  12/01/09 Consult notes DOS 11/22/09  11/24/09. DX: rhabdomyolysis, myoglobinuria, possible viral infection or post vaccination associated myositis. Pt continues c/o pain and swelling in LE.									Y	10/08/2009	10/08/2009	0	11/30/09 Lab and Diagnostic studies for DOS 11/20/09: Na: 134 mEq/l, WBC 28 (H), neutrophils 87 (H), lymphocytes 5 (L); ESR 67 (H); CSF: 10 white blood cells, 2 red cells, 81 glucose, O2 sat 92%, CPK 3,636, CR 0.9  12/01/09 Lab and diagnostic studies for DOS 11/22/09  11/24/09 CRP: 4.1 mg/dL (H)	UNK	UNK	Gemfibrozil	No	11/30/09  PMH: acute lymphocytic leukemia, chemotherapy 4 years ago.			1						1	Chills; Injected limb mobility decreased; Injection site pain; Tremor	FLU3~SANOFI PASTEUR~UT3175AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B030AA~1~UN~RA~TDAP (BOOSTRIX)~1	USA		Influenza
0360318	10/10/2009	MA	45.0	45		M	10/10/2009	Nausea, Dizziness, Diarrhea, Low-Grade Fever										10/10/2009	10/10/2009	0		UNK	UNK	None	No	NKA			1						1	Diarrhoea; Dizziness; Nausea; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360353	10/10/2009	WA	4.0	4		M	10/10/2009	Fever 100.5 on 10/9/09. 10/10/09->area of erythema and induration 7 1/2 x 10 cm. Local reaction vs cellulitis. Treated with KEFLEX.									U	10/08/2009	10/10/2009	2		PVT	PUB	None	None	None			1						1	Cellulitis; Erythema; Induration; Local reaction; Pyrexia	DTAP~SANOFI PASTEUR~C3140AA~5~UN~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U3205CA~5~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~D0042~4~SC~LA~POLIO VIRUS, INACT. (IPOL)~1	USA		Influenza
0360354	10/10/2009	CA	8.0	8		M	10/10/2009	Pt received flu shot yesterday 10-9-09, per mother pt woke up today at 7:00 AM with the skin where shot was given red and warmth to touch, size of 7 cm w by 5 1/2 cm. No fever or other sx noted.				Y					Y	10/09/2009	10/10/2009	1	None	PUB	PUB	FOCALIN 10 mg		None			1						1	Injection site erythema; Injection site warmth	FLUX~SANOFI PASTEUR~UT3175AA~6~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360356	10/10/2009	LA	35.0	35		F	10/10/2009	Patient was administered FLUVIRIN during pregnancy versus the AFLURIA (PF).										10/10/2009				OTH	PVT			Pregnancy			1						1	Drug exposure during pregnancy; Wrong drug administered	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360319	10/11/2009	ME	40.0	40		F	10/11/2009	Itching & swelling at the injection site; systemic allergic reaction; SOB... treated w/ diphenhydramine									U	10/10/2009	10/11/2009	1	none performed	UNK	UNK		no	Allergies to Cephalosporins, PCN's, Levoquin, Flagyl & MMR Vacine	Swelling, itching & hives~Measles + Mumps + Rubella (no brand name)~1~39.00~Patient		1						1	Anaphylactic reaction; Dyspnoea; Injection site pruritus; Injection site swelling	FLU3~SANOFI PASTEUR~U2469AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360320	10/11/2009	AZ	52.0	52		F	10/11/2009	Warm sensation injection site which travelled down arm followed by mild chest tightness, anxiety symptoms. After 10 minutes of observation, 911 called and pt. evaluated by paramedics within 30 minutes.  Pt. evaluated and refused ER transport.  BP slightly elevated at 167/89.  Paramedics left and patient developed recurrent chest tightness, throat irritation, mild disorientation, no nose or eye symptoms.  Was given epipen and paramedics were called back to scene.  Transported via ambulance to ER.  En route developed more SOB, pain under right breast.  In ER treated with ASA and chest pain protocol.  Observed for 2 hours and released.  Returned to work and felt slightly lightheaded, better with lunch.  Rest of day felt out of sorts.  All symptoms resolved completely and have not returned after night of sleep.  Evaluated by PCP day after event with no unusual findings.				Y					Y	09/23/2009	09/23/2009	0	Negative cardiac work-up.	UNK	UNK	Advair inhaler Januvia Avandia Nortryptilline Trazadone Resperidal	None	Asthma,Diabetes Mellitus, Bipolar Depression			1						1	Anxiety; Blood pressure increased; Cardiac monitoring normal; Chest discomfort; Chest pain; Disorientation; Dizziness; Dyspnoea; Feeling abnormal; Injection site warmth; Throat irritation	FLUX~SANOFI PASTEUR~U3216AA~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360321	10/11/2009	AZ	33.0	33		M	10/11/2009	45 minutes after receiving vaccine, developed sudden onset rapid heart rate, chest pressure, tingling in fingers, labored breathing with wheezing.  No throat, eye or nasal symptoms.  Approximately 30 minutes later had recurrent chest tightness, near syncope.  He called fire department and paramedics arrived in 10 minutes.  Field EKG, blood sugar, exam all normal.  BP slightly elevated transiently.  Refused ER transport.  For rest of day felt tired.  Awoke feeling well the next morning and has remained symptom free.									Y	09/24/2009	09/24/2009	0	Field EKG, blood sugar normal.	UNK	PVT	Alovert Had allergy shot 2 days prior to vaccination.	None	Allergic rhinitis			1						1	Blood glucose normal; Blood pressure increased; Chest discomfort; Dyspnoea; Electrocardiogram normal; Fatigue; Heart rate increased; Paraesthesia; Presyncope; Wheezing	FLU3~SANOFI PASTEUR~U3216AA~5~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360322	10/11/2009	MD	39.0	39		F	10/11/2009	Lip tingling, burning, developed blister, HSV appearance w/no previous history of HSV outbreak. Next day, further HSV like lesions appeared on torso/back/buttocks/chest. Vaccine given was live flu mist.									U	10/09/2009	10/09/2009	0		PUB	PUB		none	none			1						1	Burning sensation; Herpes simplex; Lip blister; Paraesthesia oral	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500754P~1~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA		Influenza
0360323	10/11/2009	NJ	59.0	59		M	10/11/2009	Bioject delivery of vaccine  large warm red swelling lasted 72 hours hoarseness, scratchy throat, dry non productive cough, runny nose (clear) , post nasal discharge, difficulty breathing & sleeping. Slight fever, body aches, cough, sneezing, sinusitus continues at 96 hours +									N	10/07/2009	10/08/2009	1	none	UNK	UNK	no history of any similar reactions to previous vaccines	none	penicillin allergy daily doses of Crestor and Protonix			1						1	Cough; Dysphonia; Dyspnoea; Erythema; Insomnia; Pain; Postnasal drip; Pyrexia; Rhinorrhoea; Sinusitis; Skin warm; Sneezing; Swelling; Throat irritation	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360324	10/11/2009	OH	65.0	65		F	10/11/2009	Patient got home and started feeling short of breath.  She tried using her albuterol inhaler, but had no relief.  She developed thick mucous, and she continued to cough up the mucous throughout the night.  She had chills to the point where the bed was shaking.  She was so cold she placed an electric blanket on top of her plus four more blankets.  She woke up the next morning feeling completely awful and unable to leave her bed.  She called me on Saturday, 10/10/09 still feeling achy and under the weather, but much better than the previous day.									Y	10/08/2009	10/08/2009	0		UNK	PUB		None	COPD, Anxiety, Gastrointestinal problems, & allergies			1						1	Activities of daily living impaired; Chills; Dyspnoea; Feeling abnormal; Feeling cold; Pain; Productive cough; Tremor	FLU3~SANOFI PASTEUR~U3209AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360325	10/11/2009	VA	4.0	4		F	10/11/2009	Small rash developed on both lower legs.  Rash worsene, spread to face, hands, arms and rest of body and began to look like hives on 10/11/09 AM.  Was seen at urgent care center on this date AM, hydroxine was prescribed to help stop itching of rash and hives.				Y					U	10/10/2009	10/10/2009	0	Ongoing.  If rash does not improve by 10/12/09 will need to seek further treatment with primary physician.	UNK	PVT	Retin A for muluscum on right wrist topically.	No	None			1						1	Pruritus; Rash; Rash generalised; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500693P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0360326	10/11/2009	MN	70.0	70		M	10/11/2009	Swelling to left hand dysphagia on Sunday 10/11/2009  11/17/09 Medica lrecords received for DOS 10/08-10/13  Final DX: Cellulitis of hand, except fingers and thumb. Weakness-generalized. Pressure Sore.   Left hand pain and swelling, increasing weakness.  Swelling. H/O CP. Xray neg. Pressure sores near gluteal cleft and hip.   ICD9 Codes: 682.9				Y	Y	6			U	10/08/2009	10/09/2009	1	Elevated WBC.  Presumed hand cellulitis started on Antibiotics. Labs & Diags: HGB 10.6 (L), HCT 33.8 (L), WBC 11 (H)	UNK	UNK	Atenolol, Sinemet, HCTZ, Zolpidem, Fosamax, Aspirin, Calcium, famotadine, furosemide, glucosamine		Cerebral Palsy, Osteoporosis, GERD, Hypertension, DVT history PMH: CP, hypertension, fatigue, GERD, anemia, veostasis, DVT, osteporosis, R hip replacement, tonsillectomy, R hip replacement. Allergies: NKA			1						1	Cellulitis; Dysphagia; Oedema peripheral; White blood cell count increased	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUAA460AA~UNK~IJ~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0360327	10/11/2009	IA	23.0	23		F	10/11/2009	Recieved h1n1 laiv around 12:15pm. At 4:30 I developed nausea and I vimitted four times. Nausea ended around 8pm. At around 8:30pm I noticed a sharp pain under right rib cage and I had difficulty breathing. This continued until 10:00pm									Y	10/10/2009	10/10/2009	0		UNK	UNK		None	None			1						1	Abdominal pain upper; Dyspnoea; Nausea; Vomiting	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500759P~UNK~~~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA		Influenza
0360328	10/11/2009	AZ	56.0	56		F	10/11/2009	Sudden coughing, shortness of breath, and wheezing approximately 3 hours after receiving vaccine. The following day fatigue, less coughing, slight achiness which resolved by evening.									Y	10/03/2009	10/03/2009	0		UNK	PVT	Benicar	No	No	respiratory~Influenza (Seasonal) (no brand name)~~54.00~Patient		1						1	Cough; Dyspnoea; Fatigue; Pain; Wheezing	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360329	10/11/2009	NE	5.0	5		M	10/11/2009	woke up at 2am with mild fever.  had mild fever on and off for about 36 hours.  slept more than usual.  started with runny nose, irratated throat, as coughing on and off. on 8th day after shot, had a lesion on leg where chicken pox vaccine was given.  day 12 took to doctor as a pox had appeared on the lession.  doc confirmed pox and lesion on site where chicken pox shot was given.  day 13 started another temp of about 100.									U	09/28/2009	10/03/2009	5	unknown	PVT	UNK	nuerontin, tranxene, topamax, lamictal, prevacid and trazadone	non	cerebral palsy from birth related injury and epilepsy at 2 years/7 months.	fever~DTaP (Daptacel)~5~4.75~Patient		1						1	Cough; Hypersomnia; Injection site rash; Pyrexia; Rhinorrhoea; Skin lesion; Throat irritation; Varicella post vaccine	FLUX~SANOFI PASTEUR~U3174EA~6~IM~RL~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|MMR~MERCK & CO. INC.~1640X~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~08654~2~SC~RL~VARICELLA (VARIVAX)~1	USA		Influenza
0360330	10/11/2009	GA	61.0	61		F	10/11/2009	Redness and Swelling (Cellulitis)of arm (right arm) at vaccine site. Treated with Keflex antibiotic and recommended warm soaks, and elevation of extremity as of 10/11/09.										10/08/2009	10/08/2009	0	treatment provided one day ago on 10/11/09 - will follow up with pt. in one day.	PVT	PVT		No.	Lupus, Congestive Heart Failure.			1						1	Injection site cellulitis; Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U3210AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1125X~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360331	10/11/2009	ID	14.0	14		F	10/11/2009	High Fever 102-103F, headaches, body and muscle aches, high heart rate, cough. Went to physician. Bed rest and ibuprofen.				Y					U	10/09/2009	10/10/2009	1	Swine flu test negative was perfromed at the physician office.	UNK	UNK	none	none	none			1						1	Antibody test negative; Cough; Headache; Heart rate increased; Myalgia; Pain; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360332	10/11/2009	NY	48.0	48		F	10/11/2009	Swelling and pain in left axilla. Tyenol and warm compresses applied without relief. Unable to take Ibuprophen. Pain & swelling persist at this time, 10/11/2009, 5:00 PM. Attempted to visit an urgent care since private MD not available on weekend but it was too late on Sunday to do so. If pain & swelling persist tomorrow will visit a doctor.									U	10/06/2009	10/09/2009	3		PUB	UNK	diovan, bystolic & detrol	none	Allergic to penicillin; Hypertention			1						1	Axillary pain; Swelling	FLUX~SANOFI PASTEUR~960336P~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360333	10/11/2009	UT	47.0	47		F	10/11/2009	Neck started to itch, breathing became difficult.  Took Alavert brand allergy medicine and used Xopenex inhaler several times over the next 12 hours.   Slept for 36 hours afterwards.									Y	09/23/2009	09/23/2009	0		PUB	PVT		no	no		UT	1						1	Dyspnoea; Hypersomnia; Pruritus	FLUX~SANOFI PASTEUR~43204AA~7+~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360337	10/11/2009	IA	26.0	26		F	10/11/2009	Nasal Congestion, runny nose, drainage into throat (slight congestion starting 10/8; worsened thru at least 10/11). Headache; sinus pressure / mild sinus pain: 10/10 starting approx. 12:30 p.m. Sneezing and Cough: Mainly started noticing 10/11 10 a.m. Suspected sinus infection starting afternoon of 10/10. Went to Urgent Clinic 7:45 p.m. on 10/10. Diagnosed with sinus infection and given amoxicillin prescription.				Y					U	10/08/2009	10/08/2009	0		UNK	UNK	Bupropion 2x per day 200 mg; Lamictal 1x per day 150 mg; Ortho Evra patch	No	Depression (BiPolar II), Anxiety; Deviated Septum; Scoliosis			1						1	Cough; Headache; Nasal congestion; Rhinorrhoea; Sinus headache; Sinus operation; Sinusitis; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~unknown~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0360338	10/11/2009	CA	26.0	26		F	10/11/2009	I took the 2009 H1N1 influenza vaccine (LAIV which is sprayed into the nose). After taking the vaccine, I have fever, cough and other symptoms as H1N1 flu.				Y					U	10/06/2009	10/08/2009	2		UNK	UNK		started on the evening of 10/08/2009		fever, cough and etc~Influenza (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~~26.83~Patient		1						1	Cough; Influenza; Pyrexia	FLU3~SANOFI PASTEUR~U3205CA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500760P~UNK~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA	Emergency room visit	Influenza
0360339	10/11/2009	OR	37.0	37		M	10/11/2009	Stuffy head feeling. Eustacian tube dysfunction. Serous otitis. Dizziness. Syptoms resolved in 36 hours.									Y	10/09/2009	10/10/2009	1	N/A	UNK	UNK		No.	No.			1						1	Dizziness; Ear infection; Eustachian tube dysfunction	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500759P~1~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA		Influenza
0360348	10/12/2009	IL	24.0	24		F	10/11/2009	Patient received a TETANUS shot (decavac) and FLUZONE shot in opposite arms. Pt fainted about 2-3 minutes after shot was given. Pt was very afraid of getting shots.									Y	10/11/2009	10/11/2009	0		OTH	UNK	Unknown					1						1	Syncope	DT~SANOFI PASTEUR~U3005BA~1~IM~LA~DT ADSORBED (DECAVAC)~1|FLU3~SANOFI PASTEUR~U3210AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360380	10/12/2009	TN	25.0	25		F	10/06/2009	Hives. BENADRYL 50 mg PO administered.									Y	10/05/2009	10/05/2009	0		PVT	PVT		None	PCN allergy			1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98438P1~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360382	10/12/2009	PA	28.0	28		F	10/12/2009	tingling in left lip - progressed to sore throat by 8:45, by 9pm increased resp rate, pain upon i nspiration, tingling in face, and sore throat continued - went to ED by 10pm, given benadryl 25mg, placed on O2 chest xray, lab work.  Sent home from ED at 5am - decreased resp rate and tingling subsided				Y					Y	10/10/2009	10/10/2009	0	CBC (WBC elevated), Chem7 and D-dimer (elevated), chest xray, urinalysis, nuclear med study.	PUB	UNK	yasmin	No illness	Allergic to penicillin, biaxin, and latex - no other issues	none~ ()~~0.00~Patient		1						1	Chest X-ray; Diagnostic procedure; Dyspnoea; Fibrin D dimer increased; Full blood count; Laboratory test; Oropharyngeal pain; Paraesthesia; Paraesthesia oral; Respiratory rate increased; Urine analysis; White blood cell count increased	FLU(H1N1)~SANOFI PASTEUR~500760P~2~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI))~1	USA	Emergency room visit	Influenza
0360383	10/12/2009	OH	38.0	38		F		Began with cough. Knot in back of throat. 10/07/09 - Eyes were swollen shut; matted, lips swollen. Denies any swelling of throat had  puffy face. Took Benadryl.									Y	10/06/2009	10/06/2009	0	None	OTH	PUB	No other meds	Little cough	None			1						1	Cough; Eye discharge; Eye swelling; Lip swelling; Sensation of foreign body; Swelling face	FLU3~CSL LIMITED~024649211A~1~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360384	10/12/2009	VA	1.26	1	.3	M	10/07/2009	Patient developed a rash that looked like erythema multiforme rash 5 days after receiving INFANRIX, HAVRIX, and FLUZONE.									Y	09/30/2009	10/06/2009	6	None	PVT	PUB		Upper resp infection	None			1						1	Erythema multiforme; Rash	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC148100BA~5~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U3T174HA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAV311AA~2~IM~LL~HEP A (HAVRIX)~1	USA		Influenza
0360385	10/12/2009	FL	56.0	56		F	10/09/2009	Pt received FLUVIRIN to L deltoid on 9/18/09. Stated she started having pain to her L upper arm on that evening and has continued with pain to that arm. Pt reported the incident on 10/8/09.				Y					N	09/18/2009	09/18/2009	0	L brachial plexus MRI done. L upper extremity EMG ordered.	PVT	PVT		None	None			1						1	Electromyogram; Nuclear magnetic resonance imaging; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960321P~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360386	10/12/2009	FL	56.0	56		F	10/09/2009	Patient received FLUARIX ON 9/17/09 to left deltoid. Pt stated she started having pain to her left upper arm a few hours after vaccine administration. Pt continues to have pain to the left arm. Pt reported symptoms.				Y					U	09/17/2009	09/17/2009	0	Left brachial plexus MRI done. Left upper extremity EMG ordered.	PVT	PVT		None	None			1						1	Electromyogram; Nuclear magnetic resonance imaging; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA447BA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0360388	10/12/2009	IA	25.0	25		F	10/09/2009	FLUARIX given L deltoid. The next day (9/29) achiness in deltoid at injection site. Achiness has gotten worse and is the whole arm with occasional sharp pain from injection site down arm to 5 digit L hand. Has not taken TYLENOL or ADVIL. Instructed to seek evaluation by her physician.									U	09/28/2009	09/29/2009	1	None	PUB	PVT	CYMBALTA 60 mg QD	No	None			1						1	Injection site pain; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA468BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0360397	10/12/2009	NY	86.0	86		M	10/02/2009	Patient to PMD for physical. Was feeling well and received flu vaccine. Upon arriving home minutes later told wife I don't feel well and collapsed. Brought to ED in full cardiac arrest. Unable to resuscitate.  10/19/09 ER records received service date 10/2/09. Assessment: Cardiac Arrest. Patient arrived unresponsive, intubated with CPR in progress. Asystole on monitor with no spontaneous respirations. External trauma to eyes.  ICD-9 code 427.5 cardiac arrest.  12/16/09 Death Certificate received. DOD 10/02/09. Cause of Death - Hypertensive and arteriosclerotic heart disease.	Y	10/02/2009							N	10/02/2009	10/02/2009	0	None performed	PVT	OTH	None	None	Kidney stones.			1						1	Cardiac arrest; Circulatory collapse; Death; Malaise	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98441P1A~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0360398	10/12/2009	OH	46.0	46		F	09/30/2009	Itchy at site/slightly swollen. BENADRYL 25 mg po 17:15.  128/80, p 82, r 20. No resp problems-denied other symptoms. Stayed in bldg just under 1 hr, 16:30-17:25 before released.									Y	09/30/2009	09/30/2009	0		PUB	UNK	Given BENADRYL	None	None			1						1	Injection site pruritus; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838P2~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360400	10/12/2009	OH	51.0	51		F	10/05/2009	Itching face, arms, legs, trunk. Tired, joint aching, headache, disturbed sleep. Mild SOB intermittently, sx lasted until 8 am 10/4/09.									Y	10/02/2009	10/02/2009	0		PUB	PUB	DYAZIDE	Some sneezing & sore throat (mild)	HTN; allergy to tetanus; seasonal allergies; ragweed	swelling~Tetanus Toxoid (no brand name)~2~43.00~Patient		1						1	Arthralgia; Dyspnoea; Fatigue; Headache; Pruritus; Sleep disorder	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA458BA~1~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0360401	10/12/2009	ME	4.0	4		M	10/05/2009	Developed B.L. knee pain 24 hours after imms/at 48 hours purpuric rash lower legs & abd pain - classic Hen. Sch. purpura evolved over next wk.  10/22/2009 hospital records received for 9/26-9/28/2009. ED visits 9/20 and 9/22/2009. Patient initially presented to ER with rash (legs, buttocks, scrotal area and penis), arthralgias, myalgias, bilateral knee swelling, dx'd with Henoch-Schonlein purpura.  Two days later, patient presents with new c/o's abdominal pain, nausea/vomiting. Stool guiac + for blood. TX: IV steroids,  IV fluids, IV Zofran,  NSAID for joint pain. PatientI returned on 9/24/2009 with more severe/persistant abdominl pain and was admitted for tests. R/O Intussusception. DC DX: Henoch-Schonlein purpura. ICD-9 codes 535.40, E9320, E9356, 287.0, 276.51				Y	Y	4			Y	09/17/2009	09/18/2009	1	Nl UA/CBC Labs: CBC, RDW low, Neutrophils High at 78, CMP: cr 0.25 L, Cl 110 H, UA WNL,  Dx studies/Xrays: Abdominal US negative for intussusception.	PVT	PVT	None	None	None PMH: none Allergies: NKDA			1						1	Abdominal pain; Arthralgia; Full blood count; Full blood count normal; Henoch-Schonlein purpura; Purpura; Urine analysis normal	DTAP~SANOFI PASTEUR~C3139AA~5~IM~LA~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U3259EA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARCEL~MERCK & CO. INC.~0882Y~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Hospitalisation	Influenza
0360402	10/12/2009	SC	11.0	11		F	09/17/2009	Patient had HA/took IBU 200 mg.									N	09/17/2009	09/17/2009	0		UNK	PVT		None				1						1	Headache	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360403	10/12/2009	CA	26.0	26		F	10/06/2009	Rash to upper body bilat.									Y	09/28/2009	09/28/2009	0	None	PVT	PVT			None			1						1	Rash	FLU3~CSL LIMITED~06649111A~3~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360404	10/12/2009	NC	47.0	47		F	10/05/2009	Had influenza vaccine between 3pm & 4pm. By 8pm had throat swelling & difficulty swallowing, tongue itching, raspy voice and chest tightness. Seen in ED, epinephrine given SC, SOLUMEDROL & PEPCID given IV. Sent home with Rx BENADRYL, PEPCID & MEDROL DOSE PAK. 10/28/09:  Emergency Department Records received for Date of Service 9/30/09. Dx:  Allergic reaction-drug, Hypokalemia.   Assessment:  Presented a few hours after getting a flu shot with itchy, scratchy tongue and throat with difficulty swallowing as well as tightness around the chest and abdomen like a band, moderate in intensity.  Experienced change in voice, denied swelling of the tongue or mouth.  Increased anxiety noted.  Medicated with benadryl, Pepcid, Medrol Dose Pak and Micro K 20 mEq.    ICD Codes:  995.3, 995.27, 276.8, E949.6, E849.9, 905.1.			Y	Y					Y	09/30/2009	09/30/2009	0	PT; PTT; Chem8 profile; CBC. 10/28/09:  Emergency Department Records received for Date of Service 9/30/09.  Labs and diagnostics:  WBC's 15.3 (H), MCH 31.9 (H), Segs. 75.9 (H), Lymph. 19.2 (L), Mono. 3.8 (L), Eos. 0.8 (L).  Potassium 3.4 (L), Calcium 8.4 (L).	PUB	PVT	None	No	None. 10/28/09:  Emergency Department Records received for Date of Service 9/30/09.  PMH:  BTL, smoker, allergy to Compazine.			1						1	Activated partial thromboplastin time; Chest discomfort; Dysphagia; Dysphonia; Full blood count; Laboratory test; Oral pruritus; Prothrombin time	FLU3~SANOFI PASTEUR~UT3172BA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Life Threatening	Influenza
0360405	10/12/2009	TX	56.0	56		M		Pt experienced lightheadedness after receiving a FLUVIRIN vaccine. He gently lay down on the floor. Check BP 70/50 - pt rested for 45 minutes and his BP returned to normal.									Y	10/02/2009	10/02/2009	0		UNK	UNK		None	None			1						1	Dizziness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360406	10/12/2009	IN	79.0	79		M		Fever, aches, swelling of face, redness of face, cough, weakness. Antibiotics at hosp.					Y	4			Y	09/14/2009	09/15/2009	1	Reaction to pneumonia vaccine.	PVT	UNK		None				1						1	Asthenia; Cough; Erythema; Pain; Pyrexia; Swelling face; Vaccination complication	FLUX~SANOFI PASTEUR~U3204AA~UNK~IJ~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~0626Y~UNK~IJ~UN~PNEUMO (PNEUMOVAX)~1	USA	Hospitalisation	Influenza
0360407	10/12/2009	KS	45.0	45		F	10/05/2009	Mild neuritis in left upper extremity from elbow to fingers. Evaluated by our Occ. Med Clinic, no signs of anaphylaxis reaction. Prescribed ibuprofen. Reevaluated 10/2/09 and released. Neuritis resolved.									Y	10/01/2009	10/01/2009	0		PUB	PVT						1						1	Neuritis	FLU3~SANOFI PASTEUR~UT3172BA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360408	10/12/2009	IA	28.0	28		F	10/05/2009	Severe headache, blurred vision, black outs, dizziness, fever, weakness, severe neck and back tension/stiffness, nausea, loss of appetite, chills, sweats. Resulted in hospitalization x 3 days. Did not return to normal functioning until over 1 month later. 11/9/2009 MR for 11/19-11/21/2008. Patient with c/o's arthralgias, neck pain and stiffness, back pain, fever, headache and cough. Tx: IV ABX DC Dx: viral illness				Y	Y	2			Y	11/10/2008	11/12/2008	2	Head MRI; spinal tap; blood work-possible viral meningitis don't know actual results Labs: CBC, CMP, Lyme test, HSV, HIV, UA all normal, Blood cultures neg, CSF + protein, + glucose, + wbcs and + rbcs, ESR and CRP high, Influenza AB screen negative Dx studies: CXR, CT head, MRI thoracic and cervical spine all normal	PUB	OTH	ZOLOFT; birth control	None	Kidney stones PMH: nephrolithiasis Allergies: NKDA			1						1	Activities of daily living impaired; Asthenia; Blood test; Chills; Decreased appetite; Dizziness; Headache; Hyperhidrosis; Loss of consciousness; Lumbar puncture; Musculoskeletal stiffness; Nausea; Pyrexia; Vision blurred	FLU3~SANOFI PASTEUR~U2771AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0360410	10/12/2009	VA	52.0	52		M	09/29/2009	Pt reported weakness, dizziness approx. 15-20 min post injection. BP/pulse normal (138/78, 65 bpm). Pt continued to rest for 40 additional minutes. Declined EMS service. No EMS called. Symptoms subsided. Pt left pharmacy without incident. RPH unable to reach pt for follow up.									Y	09/29/2009	09/29/2009	0	BP 138/78 Pulse 65	OTH	OTH	Unknown	Weakness/dizziness	Hypertension, others ukn			1						1	Asthenia; Dizziness	FLU3~CSL LIMITED~07849111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360411	10/12/2009	NY	39.0	39		F	10/01/2009	After 2 minutes from time of injection, tongue swelled, chest tightness, difficulty breathing, hives. Treated in Emergency Dept. with Epinephrine 0.3sq 02 and Prednisone 20mg PO.				Y					Y	09/26/2009	09/26/2009	0		PUB	PVT		None	Allergy to Cipro and Bee Sting			1						1	Chest discomfort; Dyspnoea; Swollen tongue; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960356P~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360413	10/12/2009	CA	41.0	41		F	09/30/2009	Pt complained of faintness, sob, heaviness and heart racing. Injected 0.3 epinephrine and called 911. Paramedics arrived and checked vitals. Pt was not transported and allowed to leave at 11:25.									Y	09/30/2009	09/30/2009	0	Pulse > 120 bpm	PUB	PVT			Asthmatic	10/01/2008~Pneumo (no brand name)~1~40.00~Patient		1						1	Dizziness; Dyspnoea; Heart rate increased; Palpitations; Sensation of heaviness	FLU3~SANOFI PASTEUR~U3185AA~1~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360414	10/12/2009	NY	94.0	94		F	09/30/2009	Allergic reaction to flu shot given 9/25/09. I broke out in hives. Treatment was 14 days of ZYRTEC 10 mg taken 1 x day. Dr (dermatologist) diagnosed and prescribed ZYRTEC. Still under treatment until 10/11/09.				Y						09/25/2009	09/25/2009	0	Observation of dermatologist on 9/25/09.	PUB	PVT	METOPROLOL 50 mg; FEAROL 65 mg; ocuvite; centrum silver; aspirin 81 mg; caltrate with D	None	None			1						1	Hypersensitivity; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360416	10/12/2009	MA	62.0	62		F	10/02/2009	Pt rcvd ADACEL, FLUZONE, and PNEUMOVAX on 9/30/2009, seen 10/2/09 for localized erythema/induration (6.5 x 8.0 cm L deltoid and 3.0 x 3.0 cm R), body aches, chills. Treated with TYLENOL, warm/cold compresses for comfort. Pt has follow up appt 10/5/09 to recheck.									Y	09/30/2009	09/30/2009	0	None	PVT	PUB	Numerous chronic meds for DM, lipids	DM, gastritis, diverticulosis, HTN, candida	TALWIN, CT dye, PREDNISONE	vaccine reaction~ ()~~0.00~Patient		1						1	Chills; Injection site erythema; Injection site induration; Pain	FLU3~SANOFI PASTEUR~43196AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1296X~1~IM~LA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C3355AA~2~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0360418	10/12/2009	OH	22.0	22		F	10/05/2009	Difficulty breathing, wheezing, sore throat. Went to ER on 10-1-09 and given breathing treatment which ended her symptoms.				Y					Y	10/01/2009	10/01/2009	0		PUB	PUB	Prenatal vitamins	None	Allergy to shellfish			1						1	Dyspnoea; Oropharyngeal pain; Wheezing	FLU3~SANOFI PASTEUR~U3207AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360421	10/12/2009	OH	17.0	17		M	10/05/2009	No adverse event. Administered CSL AFLURIA Lot #1549211A  to a 17 yr. old patient. Vaccine is intended for use on 18 yr. old and older. Patient waited 20 minutes and reported no side effects.									Y	10/05/2009				PUB	PVT		None				1						1	Inappropriate schedule of drug administration; No adverse event	FLU3~CSL LIMITED~01549211A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360422	10/12/2009	IL	59.0	59		F	10/05/2009	High fever and aches for six days. Went to see family MD on 9/21/2009 and Dr. put her on 12 days of PREDNISONE (reducing dosage).				Y					Y	09/14/2009	09/15/2009	1	Urinary Tract Infection-negative	PUB	OTH	ENBREL; METHOTREXATE	Arthritis-no other	Arthritis			1						1	Bacterial test negative; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U3185AA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360423	10/12/2009	GA	55.0	55		F	10/04/2009	Ringing of ears and sound sensitivity.									N	09/25/2009	09/25/2009	0		PVT	PVT		None	Mold; trees; Asthma.			1						1	Phonophobia; Tinnitus	FLUX~SANOFI PASTEUR~U3179AA~7+~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~MERCK & CO. INC.~9722106~UNK~UN~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360424	10/12/2009	CO	0.82	0	.8	M	10/05/2009	Hives approximately 15 min post vaccine.									Y	09/30/2009	09/30/2009	0	None	PVT	PVT	None	None	Allergies to nuts/milk			1						1	Urticaria	FLU3~SANOFI PASTEUR~U3190AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360425	10/12/2009	WA	74.0	74		F	10/05/2009	Lightheaded, fever 101 degree, vomit, nausea, mild headache, redness at injection site of FLUZONE.									Y	09/28/2009	09/29/2009	1		PUB	UNK		None	Allergic rhinitis, allergy to PENICILLIN, sulfa. Hypothyroid, HTN	Nausea/temp~Influenza (Seasonal) (no brand name)~UN~35.00~Patient		1						1	Dizziness; Headache; Injection site erythema; Nausea; Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~U3259FA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0527Y~2~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360426	10/12/2009	IN	41.0	41		F	10/05/2009	Knots on back of my head. 10/2/2009. Rash all over body 10/3/09. Today unable to move neck.				Y					Y	10/01/2009	10/02/2009	1	CBC, UA	PVT	PVT	METFORMIN HCI; VESICARE; VERAPAMIL HCI CR; LANOXIN; ALLEGRA; KARIVA; omeprazole; FLONASE; guaifenesin; HYDROCHLOROTHIAZIDE; ACYCLOVIR; multiple vitamins; fish oil	None	Mixed incontinence urge and stress; allergic rhinitis; palpitation; DM w/o complication Type II; compartment syndrome; plantar fasciitis; gestational diabetes mellitus; varicose vein; pain in joint, pelvic region and thigh; abdominal pain; obese; melasma; neuralgia			1						1	Full blood count; Mass; Musculoskeletal stiffness; Rash generalised; Urine analysis	FLU3~SANOFI PASTEUR~U3203AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360427	10/12/2009	MN				M	10/05/2009	Received INFUENZA vaccine 10/01/2009 pm. 10/21/2009 site discomfort. 10/3-4 swelling under arm (left) tender to touch. 10/5 swelling decreased less tender orange size.									U	10/01/2009	10/03/2009	2	None	PUB	PUB	None	No	No			1						1	Injection site pain; Oedema peripheral; Pain in extremity; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA456BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|MMR~MERCK & CO. INC.~061BY~UNK~SC~RA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA		Influenza
0360428	10/12/2009	WI	13.0	13		F	10/02/2009	Redness and itching at site of immunization beginning within 1-2 hours and increased redness and itching at site over next 48 hours. Also had nausea and puffy eyes 24 hours after vaccine. No fever, no other rashes. History of questionable chickenpox (mild) after 1st VARRICELLA vaccine.				Y					U	09/30/2009	09/30/2009	0	None	PVT	PVT	None	None	None			1						1	Eye swelling; Injection site erythema; Injection site pruritus; Nausea	FLU3~SANOFI PASTEUR~U3173DA~3~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0702x~1~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2876AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~GLAXOSMITHKLINE BIOLOGICALS~AC52B041BA~UNK~IM~LA~TDAP (BOOSTRIX)~1|VARCEL~MERCK & CO. INC.~0334Y~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0360429	10/12/2009	PA	64.0	64		M	10/07/2009	R arm was sore 10/5/09, 10/6/09. Noticed redness and warm to touch on 10/7/09. Saw HS clinic-rx CEPHALEXIN 500 mg po QID x 7 days.									U	10/05/2009	10/07/2009	2		OTH	PVT	PLAVIX; TOPROL; combination pill; MECLIZINE; CADUET	No	Cardiac, NKDA			1						1	Drug hypersensitivity; Erythema; Pain in extremity; Skin warm	FLU3~CSL LIMITED~~UNK~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~~2~UN~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360430	10/12/2009	WI	57.0	57		F	10/05/2009	Day after PNEUMOVAX and FLUZONE, developed arm pain bilaterally. When coughed pain went up arm and in chest. Developed fever of 101.4 degrees. 2 days after shots, felt dizzy and dyspneic, with rapid heart rate. Did not receive medical attention. Had had flu shot for past 9 years without incident.									Y	10/01/2009	10/02/2009	1	None	PVT	PVT		None	HTN, sleep disorder. Med allergies: oxaprozin; flexon; neosporin; VIOXX			1						1	Chest pain; Cough; Dizziness; Dyspnoea; Heart rate increased; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U3200AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0625Y~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360433	10/12/2009	IL	77.0	77		F	10/06/2009	Pneumonia shot temperature of 102 for 24 hours. Site of injection was swollen from shoulder to wrist one inch around entire arm-very painful-lasted four days.									Y	09/27/2009	09/27/2009	0		OTH	UNK	SYNTHROID, 100mg; ZOCOR, 10mg; Lisinopril, 2 1/2mg	None	None			1						1	Body temperature increased; Injection site swelling; Oedema peripheral; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0360434	10/12/2009	IA	2.0	2	.2	M	10/05/2009	Blotchy macular eruption close to site of administration. Rash was painful. Treated with oral antihistamine. (Rash was nearest to site of FLUZONE vaccine).									N	10/02/2009	10/05/2009	3		PVT	OTH						1						1	Injection site pain; Injection site rash; Rash macular	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B102CA~UNK~UN~RL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~U3259CA~UNK~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~MERCK & CO. INC.~0950Y~UNK~UN~RL~HEP A (VAQTA)~1|HIBV~SANOFI PASTEUR~UF708AA~UNK~UN~LL~HIB (ACTHIB)~1	USA		Influenza
0360435	10/12/2009	ME	29.0	29		M	09/30/2009	Approx 1 hr after injection pt c/o not feeling well. Found to be tachycardic, Left ear felt plugged, swollen cervical lymph nodes, difficulty swallowing, Sent to ED and treated. Had Hx of heart transplant 11 years ago.10/26/2009 records from ED visit 9/30/2009. Patient presents with sx of feeling off balance, weakness, feeling flushed, and vision being '''weird. PE was normal. Tx: F/up with PCP 10/1/2009. DX: ? TIA abnormal presentation.				Y					Y	09/30/2009	09/30/2009	0	Labs: CBC, Neutro 81 high, Lymphocytes 13 low, CMP: BUN 38, K 5.4 both high Dx tests/Xrays: Ct head wnl, EKG wnl, CXR	PVT	OTH		None known	Heart transplant 11 years ago PMH: CAD, CVA, Heart Transplant, Staph infection rt elbow Allergies: Vancomycin, Dobutamine			1						1	Dysphagia; Ear discomfort; Lymphadenopathy; Malaise; Tachycardia	FLU3~SANOFI PASTEUR~U3214AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360437	10/12/2009	WI	11.0	11		M	10/02/2009	Patient received vaccine and returned to home with mother called to report full body hive reaction within 1 hour of vaccine, patient given Benadryl 12.5 mg. F/u phone call 1 hour later and problems reported no shortness of breath / resp. distress.									Y	09/23/2009	09/23/2009	0	None	PUB	PVT	None	None Known	Allergy - Augmentin			1						1	Urticaria	FLU3~SANOFI PASTEUR~U3176FA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360438	10/12/2009	TX	69.0	69		F	09/30/2009	Approximately 24 hour low grade fever, general malaise. Injection site reaction, redness, soreness, pain localized on arm. Patient had improved (no fever) when calling pharmacy (9-30-09 1:30).									Y	09/28/2009	09/29/2009	1		OTH	OTH		None	None given			1						1	Injection site erythema; Injection site pain; Injection site reaction; Malaise; Pain; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98435P1~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0823Y~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360439	10/12/2009	TX	70.0	70		F	09/11/2009	-Severe pain at injection site and 3 inches below. -Redness, swelling, fever, and blister 3 inches below injection site. -was seen by ANP-BC and was treated as allergic reaction.				Y					Y	09/10/2009	09/10/2009	0		OTH	PUB		None				1						1	Hypersensitivity; Injection site erythema; Injection site pain; Injection site swelling; Injection site vesicles; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~L97840P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360445	10/12/2009	OR	45.0	45		F	09/29/2009	Had flu shot on Tuesday 9/15/09. Swelling and pain began 9/16 and lasted until 9/24/09. ADVIL first Wednesday AM took 9/16 ROBAXIN the night before. Swelling improved with ADVIL resolved after 8 days. Fibromyalgia x 15 years.									Y	09/15/2009	09/16/2009	1		PUB	UNK		No	Fibromyalgia		OR200943	1						1	Pain; Swelling	FLU3~SANOFI PASTEUR~U3193AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360446	10/12/2009	MN	34.0	37		F	10/12/2009	fever of 101 degrees; significant muscle aches; sore throat x2 days									Y	09/02/2009	09/02/2009	0		UNK	UNK	none reported	none reported	none reported			1						1	Myalgia; Oropharyngeal pain; Pyrexia	FLU3~CSL LIMITED~08749111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360447	10/12/2009	WI	12.0	12		F	10/12/2009	Extreme pain in arm at shot location, unable to lift arm for two days above her heart level.  On 09/23/2009 patient had the diarrhea, severe stomach cramps and fainted, falling off toilet into my arms. Patient was mumbling and unaware of what was happening. Patient pale, cold, clammy skin, lips white.  Able to get her into bed and color started to come back. Had patient drink water slowly. Within 30 minutes patient was back to normal but still had the diarrhea with severe stomach cramps for several hours off and on.  If I would not have been in the bathroom with her the first time she would have hit her head on the bathtub when she fainted. She could have easily have inured herself in the fall. I have no intentions of ever getting the H1N1 shots/mist for her or any other flu shot for her entire life. I work in a hospital and do not plan on getting the flu shots either, not tested enough and any chance of adverse reactions is a major concern.									Y	09/17/2009	09/17/2009	0		UNK	UNK		None	None			1						1	Abdominal pain upper; Cold sweat; Depressed level of consciousness; Diarrhoea; Fall; Injected limb mobility decreased; Pain in extremity; Pallor; Syncope	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360448	10/12/2009	NY	44.0	44		M	10/12/2009	Severe shoulder, arm, neck pain.  Ultimately loss of strength in shoulder and arm.				Y					Y	11/07/2008	11/28/2008	21	Parsonage Turner Syndrome	UNK	UNK		No	No			1						1	Asthenia; Musculoskeletal pain; Neck pain; Neuralgic amyotrophy; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360450	10/12/2009	MN	65.0	65		F	10/12/2009	ERYTHEMA, PRURITIS, HIVES									Y	09/02/2009	09/02/2009	0		UNK	PUB		none reported	none reported			1						1	Erythema; Pruritus; Urticaria	FLU3~CSL LIMITED~08749111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360451	10/12/2009	NC	15.0	15		F	10/12/2009	sudden sever headache followed by vomiting; numbness in hands followed by aching in arms which moved into legs; cold hands/feet; fever 101; administered acetminophen; symptoms subsided after a few hours then returned the next day as extreme fatigue; cold hands;fever 101.5; treated with acetimenophen; symptoms subsided then changed by this morning to sore throat and chest with occasional mild cough, no sputnam. fever has not returned as of 11:05 am.									N	10/09/2009	10/10/2009	1	none	UNK	UNK	multivitamins and certizine hydrochloride 10 mg for seasonal hayfever	no	no			1						1	Cough; Fatigue; Headache; Hypoaesthesia; Oropharyngeal pain; Pain in extremity; Peripheral coldness; Pyrexia; Vomiting	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500754P~1~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA		Influenza
0360453	10/12/2009	VA	54.0	54		F	10/12/2009	Vaccine was administered in left arm very near shoulder joint. Minor ache progressed to major discomfort over first 72 hours. Soreness, stiffness and muscle pain extended throughout entire arm into neck, shoulder and upper back. Could not raise arms over head for three weeks. Pain relieved somewhat with Tylenol, but did not begin to lessen until three weeks after vaccine was administered.									Y	09/22/2009	09/23/2009	1		MIL	MIL	lisinopril, levothyroxine, Effexor xr, Prilosec, calcium, Tylenol	No.	Hypertension, hypothyroidism			1						1	Back pain; Discomfort; Drug administered at inappropriate site; Injected limb mobility decreased; Musculoskeletal pain; Musculoskeletal stiffness; Myalgia; Neck pain; Pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360454	10/12/2009	VA	47.0	47		F	10/12/2009	Dizziness when changing positions - especially when getting up from lying down.  Has lasted until today (Oct 12).  I plan to call my primary doctor today.										10/03/2009	10/07/2009	4		UNK	UNK		No	No			1						1	Dizziness postural	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500760P~1~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA		Influenza
0360455	10/12/2009	TX	47.0	46		F	10/12/2009	Limited motion in arm, shooting pain, joint swelling, stiffness, tightness in shoulder										09/28/2009	10/08/2009	10	Doctors appt for diagnostic tests to be done on Oct. 13th.	UNK	PVT		None	None			1						1	Joint swelling; Mobility decreased; Musculoskeletal discomfort; Musculoskeletal stiffness; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~UNK~~~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360456	10/12/2009	MN	29.0	29		F	10/12/2009	Please note that this individual is a HCW. Developed fever, SOB, N/V with coughing, headache.  Initial episode of ILI began on 10/1 (out from work until 10/8. Saw physician 1 week ago (10/5)for follow-up after having been on Prednisone, Albuterol and Codiene cough medication and received clearance to return to work. Stated since receiving the H1N1 FluMist vaccine on 10/8 her symptoms worsened.  10/13/09 ED/Outpatient Clinic records received service dates 9/30/09 to 10/11/09 Assessment: H1N1 Suspected. Patient presents with fever, productive cough, weakness, chills, shortness of breath, runny nose, sinus drainage, hurts to breath, headache, vomiting. Mild erythema pharynx. Respiratory distress, rapid respiratory rate, tachycardia.  10/13/09 PCP medical records from 9/15/09 to 9/30/09 hospital records 10/11/09 to 10/13/09. Assessment: Influenza like illness. Patient presents with anxiety, productive cough with yellow sputum, fatigue. Dizzy spells. Chest pain. Admitted for influenza like illness, respiratory distress and tachycardia. Shortness of breath with activity. Head pain.  10/29/2009 Discharge summary received for DOS 10/11-10/12. Final DX not provided.  Brief discharge summary noting multiple treatment meds including prednisone, Duoneb, and Tamiflu. Pateint to rtc in 5-10 days for follow-up					Y	2			Y	10/08/2009	10/10/2009	2	10/13/09 ED/Outpatient Clinic records received service dates 9/30/09 to 10/11/09 10/13/09 PCP medical records from 9/15/09 to 9/30/09 hospital records 10/11/09 to 10/13/09. LABS and DIAGNOSTICS: Rapid FLU A/B Antigen (-). CBC - WNL. CHEM - WNL. DIMER - WNL. Pulse Ox 93% Room Air 97% on O2.  LABS and DIAGNOSTICS: O2 Sat 95% on room air. CBC - Neut 82% (H) Lymph 7% (L) Hemoglobin 16.4 g/dL (H) MCH 32 pg (H). Blood culture - No growth. Chest X-ray - WNL.	UNK	UNK		HCW Employee had just ended a prescribed course of Prednisone on 10/5/09 and had recently been away from work (HCW) for approx. 10 days due to ILI.	Employee neglected to share with vaccinator that she had been diagnosed with exercise induced asthma as a child.  Screening tool was also used and this did not trigger acknowledgement of this history by the employee. 10/13/09 ED/Outpatient Clinic records received service dates 9/30/09 to 10/11/00. Postinfectious cough. Anxiety. Patient presented with runny nose, congestion, coughing, fever, body aches and fatigue. Short of breath. Exercise induced asthma.			1						1	Condition aggravated; Cough; Dyspnoea; Headache; Influenza like illness; Nausea; Pyrexia; Vomiting	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500756P~1~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA	Hospitalisation	Influenza
0360457	10/12/2009	MD	38.0	38		F	10/12/2009	Went to get out of bed and immediately fell down as if my legs weren't there. No dizziness, just no feeling.  This happened one more time about 5 minutes later when trying to get up from the toilet.  Since then, fell one more time on 10/2, but I walk slow, holding onto whatever is near and have to focus on my walking.  Tingling and numbness in fingers, hands and legs, and mostly cannot feel right side of body. 11/9/2009 records from Neuro MD  2/2009 and ED records for 10/8-10/9/2009. Patient with c/o's weakness, numbness/tingling lower extremities, tingling in fingertips and multiple falls. PE noted loss of pinprick and decreased vibration. PT eval, patient dc'd home with cane/walker. Dx tests neg. DC DX Lower extremity weakness. ICD-9 349.9 11/09/09 ICD9 codes and Discharge summary for DOS 10/08/09-10/09/09.  Final DX for 10/08-10/09: Lower extremity weakness.  C/O numbness, tingling, mutiple falls.  Paresthesias medial hands and fingers, face , lips, tingling numbness. Has had mild memory loss/forgetfullness. H/O previous ED visits for tremulousness/ severe HA. Increased fatigue. Decreased trigeminal neuralgia sx.. Embelishments on sensory exams. CT and MRI neg. Out patient PT. D/c to home with cane and walker.   1/28/09: Neuro consult visit. C.o shooting pain while getting teeth cleaned/root canal. Severe burning of jaw. Procedure stopped. Pain constant. Trigeminal neuralgia flare.  ICD9 Codes: 349.9				Y					N	09/28/2009	09/30/2009	2	My neurologist and I are still in process of trying to figure out what could be causing this all of a sudden sensory loss.  I feel it has something to do with the seasonal flu shot, as this is the first one I have ever gotten and it appears to have onset about a day after having it.  Had MRI of brain, and spine (all normal).  Will have lumbar puncture scheduled for later this week. Further blood work to come as well. Labs done 2/2009 included CBC, BMP, HGB A1C, Lyme test, Vit D and B12, CRP were normal,  ESR high Dx tests: MRI brain done 10/06 neg, MRI C, T and L spine done 10/8/2009 normal, Ct head done 10/2/2009 normal	MIL	MIL	Depo-provera injection every 13 weeks - no reactions to this ever and have been on this for 7 years.  Topamax 125 mgs / day - same strength for over 2 years now, Chlordiazepoxide-Clidinium - 1 capsule twice a day.	none	Trigeminal neuralgia and Long term undiagnosed Gastro-intestinal issues. PMH: trigeminal neuralgia PMH: Chronic abd pain, BPV, appendectomy, family h/o HTN, DM Allergies: NKDA			1						1	Fall; Gait disturbance; Hypoaesthesia; Nuclear magnetic resonance imaging brain normal; Nuclear magnetic resonance imaging normal; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960321P~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360458	10/12/2009	NC	5.0	5		M	10/12/2009	diaphoresis, pallor and fainting within ~ 5 minutes of vaccination; rescue squad was called, child stabilized and mom chose not to go to ER via rescue									Y	10/12/2009	10/12/2009	0	02 sat 99% at time of EMS assessment, left clinic ambulatory in no distress approximately 30 minutes from onset of sx.	PUB	PUB		No, mom reported as healthy	No			1						1	Hyperhidrosis; Oxygen saturation normal; Pallor; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~9721601~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500754P~1~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA		Influenza
0360460	10/12/2009	IL	58.0	58		F	10/12/2009	pain in left upper arm,  like muscle discomfort and I couldn't lift my [left] arm well, without discomfort,  above shoulder height. She has been able to lift both arms fully unaided, though painful at times with the left arm. The discomfort has been intermittent,does not hurt in a resting position. Has been helped by ibuprofen, but it has taken up to 2 hours to obtain any relief from the ibuprofen once she has taken it.									N	09/20/2009	09/21/2009	1		UNK	PVT		no	Hypertension, Mild anxiety			1						1	Injected limb mobility decreased; Pain in extremity	FLU3~SANOFI PASTEUR~U3191AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360461	10/12/2009	WA	48.0	48		F	10/05/2009	Pt c/o lg local swelling at injection site, states arm hot to touch.				Y					U	09/29/2009	10/01/2009	2		PVT	PVT	COZAAR; Metformin; HCTZ; Atenolol	No	Allergies- Lisinopril; Type II Diabetes			1						1	Injection site swelling; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97847P1~2~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1125X~2~UN~LA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~C3250BA~UNK~UN~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0360462	10/12/2009	NY	22.0	22		F	10/01/2009	Malaise, chills, lightheadedness, localized injection site erythema / tenderness within Flu vaccine administration Lung Burning sensation within 12 hrs after .									Y	09/29/2009	09/29/2009	0	None	OTH	UNK	Yasmin; Albuterol; Minocycline	None	Exercise induced asthma			1						1	Burning sensation; Chills; Dizziness; Injection site erythema; Injection site pain; Local reaction; Malaise; Respiratory tract irritation	FLU3~SANOFI PASTEUR~U3213AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360463	10/12/2009	PA	10.0	10		F	10/01/2009	10 year old received Hepatitis A vaccine on 9/25/09 and she developed papular erythematous 7 cm x 12 cm . Area of a rash at injection site.									Y	09/25/2009	09/29/2009	4		PVT	PVT		No				1						1	Injection site rash; Rash erythematous; Rash papular	FLUN3~MEDIMMUNE VACCINES, INC.~500715P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~MERCK & CO. INC.~U739Y~2~IM~LA~HEP A (VAQTA)~1	USA		Influenza
0360465	10/12/2009	LA	71.0	71		F	10/06/2009	Pt received flu and pneumonia vaccines at approx 1:00/pm. On 10/15/09 received phone call from husband at 8:10/am on 10/16. Stated wife began to have fever and chills at approx 6:30/pm on 10/15/09. temp 102.5, experienced weakness took ASA for symptoms still experiencing weakness temp 100.5. Will see PMD.									U	10/05/2009	10/05/2009	0	Unknown	PUB	PUB	Unknown					1						1	Asthenia; Body temperature increased; Chills; Pyrexia	FLU3~SANOFI PASTEUR~U3190AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1163X~6~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360466	10/12/2009	NC	48.0	48		M	10/05/2009	Pt received FLUVIRIN 10/2/09. Pt presented 10/5/09 with a rash on his trunk region. Pt had taken a BENADRYL and was advised to take more BENADRYL and an oatmeal bath. Pt stated he was not having any problems breathing. Pt did not have swelling of the eyes, throat.									U	10/02/2009	10/05/2009	3		OTH	OTH		None	None			1						1	Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98437P1A~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360467	10/12/2009	CT	23.0	23		M	10/03/2009	Pt stated that he vomitted 0.5 hr after receipt of FLUMIST. Pt stated that he had abdominal pain this morning and vomitted last evening. Pt came to clinic and said he was better.									Y	10/03/2009	10/03/2009	0		MIL	OTH		Pt stated he had abdominal pain, but stated he was ok	No			1						1	Abdominal pain; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500725P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360468	10/12/2009	OH	46.0	46		F	10/06/2009	Chills, fever, rash on neck, chest, arms, SOB. Went to ED for breathing treatment after inhalers didn't work.				Y					Y	09/28/2009				PVT	OTH	Unknown-chemo	None	On chemo for cancer			1						1	Chills; Dyspnoea; Pyrexia; Rash	FLU3~SANOFI PASTEUR~U3190AA~7+~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360469	10/12/2009	CT	64.0	64		F	10/08/2009	Brief exacerbation of baseline asthma (had to resort rescue inhaler) Low grade T(99) 2-3 cm sore spots at injection site left arm.									Y	10/05/2009	10/05/2009	0		PVT	PVT	Zocor 10mg; Advair discus 100/50; Diovan 80 mg; Flonase	None	Doxycycline -> rash; CIPRO-CNS Rxn; LIPITOR-myalgias; DEMEROL-> vomiting.			1						1	Asthma; Body temperature increased; Injection site pain	FLU3~SANOFI PASTEUR~U3192AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360470	10/12/2009	OH	56.0	56		M	10/01/2009	Developed L neck pain, stiffness, decreased ROM and headache within minutes of receiving FLUZONE vaccination.										10/01/2009	10/01/2009	0		PUB	PUB	Advil; PROZAC; PREMARIN; B12; ALLEGRA D; ATENOLOL; CELEBREX;K-DUR; ferrous sulfate	Headache 9/18-9/21/09	Zomax, dust, citric acid, pollen, molds, dander, latex			1						1	Headache; Joint range of motion decreased; Musculoskeletal stiffness; Neck pain	FLU3~SANOFI PASTEUR~U3253DA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360471	10/12/2009	OR	44.0	44		F	10/06/2009	Approximately 12 hours after vaccine awoke with hot burning/itching of soles of feet, outer ears and scalp, red rash observed on inner thighs, genitals, buttock, arms torso. Took BENADRYL 18 hours took LORATIDINE 20 mg and ATARAX 20 mg with good relief, have cont med next 6 days. On day 3 rash decreased on feet & head.  Torso had blanket of welts. Hoarse voice, sore throat and painful pyloric sphincter for 1-5 days.				Y					Y	09/30/2009	10/01/2009	1	None	OTH	UNK	LEVOTHYROXINE 100 mcg; MOBIC 7.5 mg; MVI, TYLENOL, BACLOFEN 5 mg	No	Hx gastritis; Tetanus; NSAID allergy; Hx Hypothyroid; Osteoarthritis	severe pain swelling~Tetanus Toxoid (no brand name)~1~30.00~Patient		1						1	Burning sensation; Dysphonia; Myalgia; Oropharyngeal pain; Pruritus; Rash erythematous; Skin disorder; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA454BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0360472	10/12/2009	KY	68.0	68		F	10/05/2009	Nervousness, headache, dizzy, pressure in head, cold, weak, could not sleep, in bed 2 1/2 days, rapid heart beat, pain in shoulder and arm. It felt like I was having a heart attack.									Y	09/25/2009	09/25/2009	0		UNK	UNK						1						1	Activities of daily living impaired; Asthenia; Dizziness; Feeling abnormal; Feeling cold; Headache; Heart rate increased; Insomnia; Musculoskeletal pain; Nervousness; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360474	10/12/2009	AZ	49.0	49		F	10/02/2009	First time  flu shot 5mins after injection patient became very pale and felt nausea. Face became very flushed = hives around face and neck complained of throat feeling itchy and tight. Epi given and called 911.									Y	09/30/2009	09/30/2009	0	Patient stated they kept her in the hospital because of elevated blood sugar.	PUB	PVT	Insulin	None	Diabetic			1						1	Blood glucose increased; Flushing; Nausea; Pallor; Throat irritation; Throat tightness; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960354~1~IM~RL~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360475	10/12/2009	OH	58.0	58		F	10/02/2009	Itching in upper arm 8 hours after injection. Upper arm dull ache/pressure 24 hours after injection. Dull ache and pressure down into forearm 36 hours after vaccine.									U	10/01/2009	10/01/2009	0		PVT	PUB	EFFEXOR; DIOVAN; DETROL LA	No	HTN, Incontinence			1						1	Limb discomfort; Pain in extremity; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA458BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0360476	10/12/2009	NJ	75.0	75		F	10/05/2009	Raised red spots on my body which itch. Tolerable in day time, worse at night after going to bed. 1% Hydrocortisone cream, Bio freeze and ice. Situation still exists. BENADRYL recommended. Not taken due to potential drowsiness.									N	09/09/2009	09/09/2009	0	None	OTH	OTH	None	None	None			1						1	Rash erythematous; Rash pruritic	FLU3~SANOFI PASTEUR~U3209AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360477	10/12/2009	NY	44.0	44		F	10/02/2009	Soreness at injection site with 3.75 x 3.5 cm warm, pink raised area at site.									Y	09/29/2009	10/01/2009	2		PUB	PVT	ALLOPURINOL; chlorthalidone					1						1	Injection site erythema; Injection site pain; Injection site warmth; Rash maculo-papular	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960356P~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360478	10/12/2009	IL	32.0	32		F	10/07/2009	The consumer had flu shot and had some problems where the shot was given. Patient complained of mobility problems in that arm.				Y					Y	09/29/2009	09/29/2009	0		OTH	PVT		Patient completer 14 day course	Augmentin therapy (started 09-14-09)			1						1	Injected limb mobility decreased; Injection site reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~2~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360480	10/12/2009	PA	4.0	4		M	09/25/2009	Pt woke at 23:30 with fever of 102.1 and had 6 episodes of vomiting.				Y					Y	09/23/2009	09/23/2009	0	None	PVT	PVT	None	None	None			1						1	Pyrexia; Vomiting	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B116AB~4~UN~LA~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~U3212AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~0550Y~2~SC~UN~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0886Y~2~SC~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0360481	10/12/2009	IL	54.0	54		F	10/06/2009	10/2/09 14:00-FLUZONE received. 19:00-developed coughing x 3 hrs. 10/3/09 01:00 woke up with wheezing and tightness in chest and eyes crusted shut. All day stomach churning-slight diarrhea. PM felt fine.									Y	10/02/2009	10/02/2009	0		PVT	OTH	LEVOXYL; PROMETRIUM; LEXAPRO	None	Childhood allergies, inactive thyroid, menopause			1						1	Chest discomfort; Cough; Diarrhoea; Eye discharge; Nausea; Wheezing	FLU3~SANOFI PASTEUR~U3202AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360482	10/12/2009	NC	63.0	63		M	10/05/2009	Sore throat itching rash on trunk, legs and arms.										09/22/2009	09/23/2009	1	none	UNK	UNK	Doxycycline Hyclate; Triamcinolone Acetonide; Hydroxyzine HCL; Verapamil HCL CR; ZOCOR; Omeprazole; Hydrochlorothiazide; Losartan potassium; CARDURA					1						1	Oropharyngeal pain; Pruritus; Rash	FLU3~CSL LIMITED~09149211A~1~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360483	10/12/2009	OH	32.0	32		F	09/28/2009	Tingling / numbness in arm after leaving store and came back. Went away by later that evening when we checked on patient.									Y	09/25/2009	09/25/2009	0		PUB	PVT		No				1						1	Hypoaesthesia; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360485	10/12/2009	VA	47.0	47		F	09/25/2009	About 10 minutes after vaccination, patient stated her Right hand felt, like it was asleep. It resolved completely about  60-90min later.									Y	09/25/2009	09/25/2009	0		OTH	PVT	None	None	None			1						1	Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360487	10/12/2009	CA	86.0	86		M	10/02/2009	Patient reports bruise and pain on left arm from immunization for 10 days.									Y	09/16/2009	09/16/2009	0		OTH	PUB						1						1	Contusion; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0627V~UNK~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360488	10/12/2009	ME	47.0	47		F	10/02/2009	L arm swollen, red, hot to touch, nausea, headache, swelling up into the neck then face.									Y	09/29/2009	09/30/2009	1	Saw PCP for exam	PUB	UNK			Allergy to walnuts, nothing else			1						1	Erythema; Headache; Local swelling; Nausea; Oedema peripheral; Physical examination; Skin warm; Swelling face	FLU3~SANOFI PASTEUR~U3208AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360491	10/12/2009	VA	5.0	5		F	10/03/2009	Dizzy, wobbly-couldn't walk, pale, lips turned blue. Heart rate dropped low had irregular heart beat. Sugar low immediately following mist (going for 2nd opinion).				Y					U	09/30/2009	09/30/2009	0		UNK	UNK		None	None			1						1	Abasia; Blood glucose decreased; Cyanosis; Dizziness; Heart rate decreased; Heart rate irregular; Pallor	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0360493	10/12/2009	AZ	55.0	55		F	10/12/2009	Fever, headache, dizziness. Taking 400mg. Motrin every four hours and drinking lots of fluids. Fever has broken twice, but escalates without the meds.										10/10/2009	10/10/2009	0		PUB	PVT	None	None	None			1						1	Dizziness; Headache; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~9721501~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360494	10/12/2009	AZ	14.0	14		M	10/12/2009	Fever, chills, headache, runny nose.Treating with Motrin,fluids, and rest.										10/10/2009	10/10/2009	0		PUB	PVT	None	None	None			1						1	Chills; Headache; Pyrexia; Rhinorrhoea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~9721501~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360497	10/12/2009	OH	47.0	47		F	10/12/2009	She complained of a headache--she explained that she started feeling sluggish about 3:00 PM and by 5:00 PM, she had a headache.  Later that evening, it developed into a full-blown migraine.									Y	10/09/2009	10/09/2009	0	None	UNK	PVT	None	None	No known drug allergies, history of migraines			1						1	Headache; Migraine; Sluggishness	FLU3~SANOFI PASTEUR~U3199AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360498	10/12/2009	IL	4.0	4		M	10/12/2009	Hives developed on his face at 1PM the same day as flumist was given. He continued to have hives on his face, back, arms, buttocks, and hands until 10/07/2009.  The last hives developed around 5:30 PM on 10/07/2009.  The hives were treated with Benadryl after speaking with the pediatricians office.  He developed a fever of 101 the morning of 10/07/2009.  We took him to the pediatrician office on Thursday.				Y					Y	10/04/2009	10/04/2009	0		PVT	UNK		slight cold symptoms.  Runny nose, cough in the morning.	none	hives~Influenza (Seasonal) (no brand name)~2~3.33~Patient		1						1	Pyrexia; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0360503	10/12/2009	UT	45.0	45		F	10/12/2009	Woke up with extreme weakness and fatigue.  Numbness began Thurs 10/1. Hospitalized.  Symptoms worsened until Wed 10/7.  Symptoms were presumptive Guillain-Barre Syndrome. Although treating physician did not confirm diagnosis because she did not manifest all classic symptoms and spinal fluid did not reach diagnostic levels. She was treated based on symptoms including 5 treatments of high-dose immunoglobulin therapy.  11/2/09 Hospital records and discharge summary received service dates 10/5/09 to 10/11/09. Assessment: Guillain-Barre syndrome. Hypertension possibly secondary to Guillain-Barre syndrome. Possible Addison's disease.  Post vaccination injections of corticosteroids to shoulder and foot for degenerative arthritis/tendonitis. Augmentin for presumed sinus infection. Patient presents with general weakness and fatigue for one week. Body aches, tingling skin. Numbness around knees. Paresthesias, which seemed to be ascending with possible paralysis of larger muscles. Shortness of breath. Decreased sensation ankles and toes. Wide-based gait.  Tx w/IVIG, improved & d/c to home.   ICD-9 Codes: 357.0 Acute infective polyneuritis, 401.9 Essential hypertension, 280.9 Iron deficiency anemia, V12.51 Personal history of venous thrombosis and embolism, V58.66 Long-term (current) use of aspirin.					Y	7			N	09/18/2009	09/28/2009	10	11/2/09 Hospital records and discharge summary received service dates 10/5/09 to 10/11/09. LABS and DIAGNOSTICS: ANA (+). CSF: WNL.  MRI Thoracic and Cervical Spine - Abnormal, disk protrusions at C5-6 and C6-7, mild degeneratice changes (thoracic).	UNK	UNK	None. Started on antibiotics with the initial onset of symptoms.  Did not finish the course once hospitalized.  Discharged from hospital with no medications.	None.	Anemia since childhood.  Occasional mild psoriasis.  No known drug or other allergies.  No other medical conditions. 11/2/09 Hospital records and discharge summary received service dates 10/5/09 to 10/11/09. Allergy - Bactrim. Recurrent tendinitis requiring steroid injections. Cholecystectomy. Foot surgery, bone spur complicated by MRSA. 4 C-sections. Pulmonary embolism. Chronic iron deficiency anemia.	possible childhood arthritis~Measles + Mumps + Rubella (no brand name)~~0.00~Patient		1						1	Asthenia; Fatigue; Guillain-Barre syndrome; Hypoaesthesia; Immunoglobulin therapy	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA265AB~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Hospitalisation	Influenza
0360504	10/12/2009	CA	22.0	22		F	10/12/2009	Dark spots in vision field, blurred vision, severe headache, vomiting, fatigue.										10/10/2009	10/12/2009	2		UNK	PVT		None	None			1						1	Fatigue; Headache; Vision blurred; Visual impairment; Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360505	10/12/2009	TX	0.83	0	.9	M	10/12/2009	RN gave injection x2 to right thigh and patient initially held breath for 2 seconds while crying then appeared to have approx. 3-5 seconds seizure-like activity then back to baseline activity (ie. crying). Vital signs stable patient crying. Mother reports patient has never had a seizure however Mother has hx of seizures.  Nurse practitioner evaulated patient and recommended to take pt. to ER/PCP for for further follow-up.  No other vaccines given.									Y	10/09/2009	10/09/2009	0		UNK	UNK		Unknown, per Mother on Vaccine Screening Questionaire.  Mother unaware of health issues.	None			1						1	Breath holding; Crying	FLU3~SANOFI PASTEUR~U3259BA~2~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~D48929~4~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0360506	10/12/2009	WI	54.0	54		M	10/12/2009	Twelve hours after administration, he began experiencing an exacerbation in asthma symptoms.  He started having a hacky cough and chest tightness, as well as nasal congestion.  At 24 hours, he was wheezing and felt fatigued.									Y	09/24/2009	09/24/2009	0	None	UNK	PVT		None	Asthma-under good control			1						1	Asthma; Chest discomfort; Cough; Fatigue; Nasal congestion; Wheezing	FLUX~SANOFI PASTEUR~AFLLA2766AA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360507	10/12/2009	TX	61.0	61		F	10/12/2009	Patient given vaccine at a flu employee clinic here at the central office. The patient was eventually admitted into the hospital and diagnosed with Guillain Barre Syndrome.  10/21/2009 DC summary received for dates 10/5-10/9/2009. DC DX's: GBS, HTN and Chronic Back Pain   Patient admitted for 1 week hx of sx of progressive weakness, numbness  of lower extremities and difficulty walking     10/26/2009 rec ED and MR for 10/5/10/9/2009. Dx GBS  Neuro consult on PE reflexes were absent patellas and ankles bilaterally, decreased sensation to temp and pinprick bilateral LE's.  LP, TX: IVIG					Y	18	Y		U	09/28/2009	09/29/2009	1	CSF , protien elevated 57-2  Labs: RA factor neg, CBC, CRP, ESR wnl, BMP: na low, CSF: Protein 57.2 High  xrays: MRI LS spine, MRI C-spine normal	UNK	UNK		n/a	hypertension --not on meds			1						1	CSF protein increased; Guillain-Barre syndrome	FLUX~SANOFI PASTEUR~U3202AA~UNK~IM~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0360508	10/12/2009	NC	7.0	7		M	10/12/2009	pt. received a flu shot at the school flu clinic with written permission by mother.  When I went to enter it in the database it showed the pt. had received one 2 days earlier at PCP.  I talked with both parents today via interpreter.  They stated pt. had no adverse effects and is healthy.  This reported to pts. PMD.										10/05/2009	10/05/2009	0		UNK	UNK		none known	none known			1						1	Inappropriate schedule of drug administration	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P2A~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360510	10/12/2009	ND	46.0	46		F	10/12/2009	Within moments of injection, the site became very sore and irritated.  Within24 hours the site was very swollen, red, and tender to the touch.  The swelling was almost twice the size of the muscle on the arm.									Y	10/02/2009	10/02/2009	0	None	PUB	PVT		None	None			1						1	Injection site erythema; Injection site irritation; Injection site pain; Injection site swelling	FLU3~CSL LIMITED~01949211A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360512	10/12/2009	CA	51.0	51		F	10/12/2009	Patient became dizzy approx 2 hours after receiving flu shot. Patient passed out and was taken to ER. Patient was told it could have been a vaccine related side effect.				Y					Y	10/08/2009	10/08/2009	0		UNK	OTH		None				1						1	Dizziness; Loss of consciousness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360517	10/12/2009	CA	1.42	1	.4	F	10/12/2009	After receiving Flu vaccine developed fever 101 then had two episodes of generalized tonic seizures.				Y					Y	10/05/2009	10/05/2009	0		PVT	PVT		No	No			1						1	Grand mal convulsion; Pyrexia	FLU3~SANOFI PASTEUR~UT3178CA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360518	10/12/2009	VA	33.0	33		M	10/12/2009	Pt called at 8:10pm and complained of Dizziness, Nausea, and overall not feeling well. Recommended 50mg of benadryl at 8:15pm.  Called Pt back at 8:55pm to check on Pt. Pt complained of a Tingling sensation in leg but not feeling any worse.  No Hives reported, Throat and Breathing was alryght.  Pt was recommended to monitor his condition and if condition worsened, to seek medical attention									Y	10/07/2009	10/07/2009	0		UNK	UNK		None Known	None Known			1						1	Dizziness; Malaise; Nausea; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98432p1~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360520	10/12/2009	MO	29.0	29		F	10/12/2009	SORE THROAT, FEVER BODY ACHE, HEAD ACHE										10/09/2009	10/10/2009	1		UNK	UNK						1						1	Headache; Oropharyngeal pain; Pain; Pyrexia	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500756P~2~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA		Influenza
0360522	10/12/2009	WA	1.83	1	.9	M	10/12/2009	Had a flu shot around 8:30 AM, then was acting totally normal and went to the park and played. Mom states that he went down for a nap around 10:30-12:30 PM. He woke up screaming, red and had a runny nose. Dad states that when he woke up he was having a hard time breathing. House is being painted right now. Now very lethargic. Came to pediatricians offc around 5:00 PM. On the way to the office his eyes rolled back and he fell asleep and was hard to wake up. Mom was shaking him to try and wake him up and that didn't work. Woke up when they took him out of his car seat. Was diagnosed with Altered Mental Status, as well as change in sensorium following a vaccine.				Y					Y	10/12/2009	10/12/2009	0	None	PVT	PUB	Motrin (given after vaccine); multivitamin; Omega 3	Little sniffly nose/cough. No wheezing; afebrile, per parent report.	Atypical pneumonia 7/23/09. No Known Diagnosed Allergies	Localized Redness over thigh where he received shot~DTaP (Daptacel)~4~1.50~Patient		1						1	Depressed level of consciousness; Dyspnoea; Erythema; Gaze palsy; Lethargy; Mental status changes; Rhinorrhoea; Screaming	FLU3~SANOFI PASTEUR~U3259BA~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360523	10/12/2009	TX	52.0	52		F	10/12/2009	Husband said pt said heart felt diff-pt said legs felt weak,faint and felt like she needed to use her inhaler-called 911-had her lay down-since felt faint-lady at 911 said she could use inhaler and not to give anything since paramedics were almost there-pt bp rate varied									Y	10/12/2009	10/12/2009	0		UNK	UNK	Takes Albuterol-other meds-N/A	None	Did find out pt uses albuterol-on other meds-n/a			1						1	Blood pressure fluctuation; Dizziness; Feeling abnormal; Muscular weakness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98432P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360524	10/12/2009	NM	6.0	6		M	10/12/2009	Patient recieved flu vaccine 10/6/09. 48 hrs after injection, patients left arm was still inflammed around injection site (left bicep and around upper arm). Symptoms consisted of  swollen, redness and inflammation which left arm was bigger than other arm. No fever or other serious symptoms associated with injection. Patient was given Predisone injection 10/8/08 and predisone dose po qd, day after to reduce inflamation. Prior to MD visit on 10/8/08, parents administered loratidine 5ml, benedryl gel, later cortisone cream which did not reduce inflamation. Parents had also contacted after hours md service which was advised to seek md for visit.				Y					Y	10/06/2009	10/08/2009	2	some sort of allergic reaction to flu vaccine. Patient did have flu vaccincation last year 2008 with no previous complications.	PVT	UNK		no illness	bronchial asthma, allergies seasonal and some animals			1						1	Hypersensitivity; Injection site erythema; Injection site inflammation; Injection site swelling; No reaction on previous exposure to drug	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360527	10/12/2009	KY	47.0	47		F	10/09/2009	None stated. 11/30/09 Death Certificate Received. DOD 10/03/2009. Final Cause of Death: Acute Methadone Toxicity. Additional Information - Underlying conditions: Constrictive Atherosclerotic Artery Disease.	Y	10/03/2009							N	09/22/2009				PUB	PUB						1						1	Death	FLU3~SANOFI PASTEUR~C3202AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|TDAP~SANOFI PASTEUR~C3249AA~2~IM~LA~TDAP (ADACEL)~1	USA	Results in Death	Influenza
0360528	10/12/2009	NY	3.0	3		M	10/12/2009	Pt returned to clinic on 10/9/09 complaining of runny nose and cough for three days and was diagnosed with nasal congestion and				Y					U	10/06/2009	10/06/2009	0		PVT	PUB		None documented	Well child visit - Pt has NKDA. Pt also with phimosis & dysuria on DOS.			1						1	Cough; Nasal congestion; Rhinorrhoea	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500756P~1~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1|FLUN3~MEDIMMUNE VACCINES, INC.~500687P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0360529	10/12/2009	GA	13.0	13		F	10/12/2009	Diaphoretic, chest pain, cold, clammy, 8-10 minutes after leaving store.									Y	10/12/2009	10/12/2009	0		UNK	PVT	None	None	None			1						1	Chest pain; Cold sweat; Hyperhidrosis; Nasopharyngitis	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98445P1~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360530	10/12/2009	NV	75.0	75		F	10/09/2009	L arm became edematous. Red and hot last night. Pt c/o pain also and fever.										10/08/2009	10/08/2009	0		PUB	PVT		Pt in for f/u appt.	NKA			1						1	Erythema; Oedema peripheral; Pain; Pyrexia; Skin warm	FLU3~SANOFI PASTEUR~43201AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1315Y~UNK~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360532	10/12/2009	MN	23.0	23		F	10/05/2009	Had vaccine at 15:00. Urticaria, flushing, vertigo, weakness at 15:15.				Y					Y	10/01/2009	10/01/2009	0	O2 sats=97%	OTH	UNK	Birth control pills	None	None			1						1	Asthenia; Flushing; Urticaria; Vertigo	FLU3~SANOFI PASTEUR~U3201AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360533	10/12/2009	TX	4.0	4		M	10/12/2009	Swelling, redness, warm, hard area patient left leg vaccine site.				Y					Y	10/08/2009	10/09/2009	1		PVT	PUB						1						1	Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth	DTAP~SANOFI PASTEUR~AC14B100AA~2~IM~LL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U3253AA~4~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|IPV~SANOFI PASTEUR~D0037~1~IM~RL~POLIO VIRUS, INACT. (IPOL)~1|MMR~MERCK & CO. INC.~05497~1~SC~RL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~08604~1~SC~LL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0360535	10/12/2009	CA	12.0	12		M	10/12/2009	Pt had syncope event aprrox 8 minutes after receiving vaccine. Paramedics called and cleared (pt) by paramedics. Pt fell and hit back of head on floor. Pt breathing OK and no other signs of discomfort on initial analysis (after fainting).									Y	10/08/2009	10/08/2009	0	Blood pressure, oxygen levels done by paramedics	OTH	PVT	None	None	None			1						1	Fall; Head injury; Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98445P1~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360536	10/12/2009	AK	32.0	32		M	10/12/2009	Pt received IM dose of FLUVIRIN 2009-2010 at 10:16. Reported back to pharmacist after 15 minutes that throat felt tight, could breathe but didn't feel like he could take a really deep breath. Offered to monitor further but pt declined. Went to walk-in clinic. Called pt at 16:30 for follow up and he said he was fine.									Y	10/11/2009	10/11/2009	0	Unknown	OTH	PVT	Unknown	No	Fast onset/hives to guinea pig			1						1	Dyspnoea; Throat tightness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2A~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360537	10/12/2009	WI	9.0	9		M	10/12/2009	Swelling, redness, pain at site of injection.									U	10/08/2009	10/09/2009	1		PVT	OTH	None	None	None			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U3193AA~7+~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360538	10/12/2009	NH	20.0	20		F	10/12/2009	Patient called next day to inform me that patient had severe abdominal cramps. She also mentioned that her boy also has abdominal cramps even though he didn't get the vaccine. She thinks it might be from the bad clams that they had or the vaccine.									Y	10/11/2009	10/11/2009	0		OTH	OTH	None applicable	None	None			1						1	Abdominal pain	FLU3~SANOFI PASTEUR~UT3172AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360539	10/12/2009	MN	33.0	33		M	10/12/2009	Felt warm, but did not take temp. Body aches and weak was out of balance.									Y	10/05/2009	10/06/2009	1	none	PVT	PVT				Aches~ ()~~36.00~Sibling		1						1	Asthenia; Balance disorder; Pain; Skin warm	FLU3~SANOFI PASTEUR~U3197AB~UNK~SC~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360540	10/12/2009	CO	53.0	53		F	10/12/2009	Received FLUZONE U3176FA on 9/29/2009. Developed itch rash on abdomen, 10/2 which spread 10/3 and 10/4 to back, arms, chest.									Y	09/29/2009	10/02/2009	3		PVT	OTH	None	None	None			1						1	Rash; Rash pruritic	FLU3~SANOFI PASTEUR~U3176FA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360542	10/12/2009	PA	47.0	47		F	10/19/2009	Rash redness at site with itching all over. Complaint of Pruritus (generalized) BENEDRYL 25mg x2.									Y	10/08/2009	10/08/2009	0	None	PVT	PUB						1						1	Injection site erythema; Injection site rash; Pruritus; Pruritus generalised	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA456AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0360543	10/12/2009	WI	51.0	51		M	10/12/2009	1 day after PNEUMONIA AND FLU vaccination in right deltoid, developed swollen, painful right elbow. Limited range of motion. Symptoms improving slowly at day 6.									Y	10/05/2009	10/06/2009	1		PVT	UNK		None	Stage IV Kidney disease			1						1	Arthralgia; Joint range of motion decreased; Joint swelling	FLU3~SANOFI PASTEUR~U3200AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0504Y~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~UF451BA~UNK~IM~LA~TDAP (ADACEL)~1	USA		Influenza
0360544	10/12/2009	OH	40.0	40		F	10/12/2009	Vaccine administered at 0800, started having hot flashes at approximately 12 noon followed by difficulty swallowing to emergency room at 1330 treated with IV solution MEDROL, IV PEPSID, IV BENADRYL.				Y					Y	10/09/2009	10/09/2009	0		PUB	PVT	Multivitamin		Allergy to Sulfa			1						1	Dysphagia; Hot flush	FLU3~CSL LIMITED~01449211A~7+~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0360545	10/12/2009	ME	7.0	7		M	10/12/2009	Day after vaccine was administrated the area became red, swollen to the size of palm, hard & painful.  Denied fever.  2 days following area was white with a red ring.  Today symptoms resolved.  Mom treated with cool compresses.									Y	10/09/2009	10/10/2009	1		PUB	PUB			Asthma, seasonal allergies.			1						1	Injection site discolouration; Injection site erythema; Injection site induration; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U3214AA~3~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360546	10/12/2009	AZ	5.0	5		F	10/08/2009	Pt with rash on arms, upper chest & back.  Started 2 days ago, day after flu shot.  Started right arm first where flu shot given.  Rash itches.  Received PREDNISONE orapned 10 mg.  1 tab, by mouth every twice daily. BENADRYL and advised to use AVEENO bath when necessary to relieve itching.				Y					Y	10/05/2009	10/06/2009	1		PVT	PUB	None	None	NKMA; No other medical problems.			1						1	Injection site pruritus; Injection site rash; Pruritus; Rash	FLU3~SANOFI PASTEUR~UT3175AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360547	10/12/2009	OK	47.0	47		F	10/12/2009	Received FLU shots on 9/18/2009 at 0700. Later that day - sore arm, scratchy throat, achy feeling, Several days later - now had repeated numbness that came- went to L arm and face and lower legs and scalp area. Progress to dizziness when standing and weakness to lower extremities. Continued weakness, numbness, dizziness as of 10/09/2009. 10/22/2009 records from PCP. Patient with sx of arm soreness, arthralgias, numbness/tingling of bilateral LE's, fatigue, weakness and dizziness. PE was normal, Tx: Medrol dose pak. Patient referred to neurologist when sx became progressive. 12/09/09 Neurology records received for DOS 10/16/09. Pt presented with intermittent numbness and tingling sensation of arms and legs and constant muscle weakness of arms and legs x 1 month. Assessment: large myelinated fiber neuropathy in a glove stocking distribution				Y					U	09/18/2009	09/18/2009	0	Labs: CBC: Monos-0.3- L, MCV- 79.4 L, CMP: K-3.1 L, Glucose-112 H, Cl-95 L, CO2-34 H,  CK-27 L Thyroid studies: TSH-<.01 L CRP-3.21 H, ANA neg, ESR WNL DX studies/Xrays: MRI Brain : 8mm pineal cyst otherwise WNL, Xrays LS spine: Mod disc space narrowing L5-S1 12/09/09 Labs: Lyme titer negative; pyruvic acid 0.1 mg/dL (L); RPR nonreactive; ANA negative; Glucose 155 mg/dL (H);ESR 22mm/HR (H) Diagnostics: Electromyogram:normal.  Nerve conduction studies: normal.	PVT	PVT	Armour (thyroid), Estrotest, B Complex, dimidex qod, K+Supplement 32mg	Denies fever or serious illness	Thyroidectomy, diabetes PMH: DM, Hypothyroidism Allergies: NKDA 12/09/09 PMH: allergies : cephalosporins, penicillin, sulfa, erytrhomycin, IV iodine, morphine, fentanyl, dilaudid, versed; asthma; cardiac arrhythmia; irritable bowel syndrome; hx of bengn thyroid tumor; hysterectomy; breast reduction; thyroidectomy; left rotator cuff repair; breast lumpectomy; lipoma removal left leg; ganglion cyst removal in hand.			1						1	Dizziness; Hypoaesthesia; Hypoaesthesia facial; Muscular weakness; Pain; Pain in extremity; Throat irritation	FLU3~SANOFI PASTEUR~U32576A~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360550	10/12/2009	MI	46.0	46		M	10/05/2009	Noticed swelling around eyes 3-5 hours after getting flu shot. Went to bed that evening and swelling was game when he woke up. Has had flu shot previously.									Y	09/16/2009	09/16/2009	0		PVT	OTH			NKA			1						1	Eye swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~9789P1~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360551	10/12/2009	OH	2.0	2	.9	M	10/06/2009	41/2 wx4 long area of edema and irritation on left arm. Childrens BENADRYL 12.5mg given po x one per day and ice applied.									Y	09/30/2009	10/01/2009	1	none	PVT	PVT	multivitamin	none	none			1						1	Injection site irritation; Injection site oedema	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B137AA~1~IM~LA~DTAP + IPV (KINRIX)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500691P~3~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360553	10/12/2009	VA	52.0	52		F	10/06/2009	9/28 1) Hoarseness with in 3-4 hours hives developed on 10/1/09, to arms, legs, face & neck, few on back.  Tx 1 BENADRYL gel to skin, 2. BENADRYL 25 mg - 1 pill X 3/24 hr.  BENADRYL taken for 48 hours - worked sat 10/3 & 10/4 with hives still present but 0 itching & resolving.									Y	09/28/2009	09/28/2009	0	None	PUB	PVT	None	None	None			1						1	Dysphonia; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA482BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0360561	10/12/2009	MI	19.0	19		F	10/21/2009	1day after flu shot > (flu IM U3196AA Pasteur 6/10) given in right deltoid. Pain, flushing - 7cm x 10 cm  area of redness and warmth right deltoid.									N	10/09/2009	10/10/2009	1	None	PVT	PVT	Depakote	No	Absent cerebellar vermis (congential ); Seizure; Mental retardation			1						1	Flushing; Injection site erythema; Injection site warmth; Pain	FLU3~SANOFI PASTEUR~U3196AA~6~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360567	10/12/2009	MI	43.0	43		F	10/08/2009	Numbness, pain right arm and hand weakness. Began night after vaccine. increased symptoms. DX Acute Brachial Neuritis.									N	09/22/2009	09/22/2009	0	EMG is pending	PVT	UNK		none	hypothyroid			1						1	Electromyogram; Hypoaesthesia; Muscular weakness; Pain in extremity; Radiculitis brachial	FLU3~SANOFI PASTEUR~U3184AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360526	10/13/2009	WI	46.0	46		F	10/13/2009	Intense itching in areas of sweating.  Arm Pits, groin, between breasts.  Lip tingling and wheezing. Itching & wheezing relieved with benadryl.  Itching continued with less severity for 36 hrs.									Y	10/11/2009	10/11/2009	0		PVT	UNK	Prilosec, Synthroid, Vytorin, Zyrtec, Zoloft	NO	GERD, Hypothyroid, Ragweed, tree & grass allergies			1						1	Hyperhidrosis; Paraesthesia oral; Pruritus; Wheezing	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA476AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500756P~1~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA		Influenza
0360555	10/13/2009	WV	19.0	24		F	10/12/2009	Developed headache, ears burning, hives on trunk, neck and head with itching. Felt hot and difficulty taking deep breath. Rx Famotidine 20 mg Atarax 50mg / Solumedrol 125 mg.				Y					Y	10/12/2009	10/12/2009	0		PUB	PUB		None	No allergies; Mitral Valve prolapse			1						1	Dyspnoea; Ear discomfort; Feeling hot; Headache; Pruritus; Urticaria	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500763P~1~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA	Emergency room visit	Influenza
0360557	10/13/2009	CA	58.0	58		F	10/13/2009	fever, chile,severe cough			Y							10/09/2009	10/09/2009	0		UNK	UNK		none	none		inactivatedinfluenzavacci	1						1	Chills; Cough; Pyrexia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA454AAVIS8I~2~IJ~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Life Threatening	Influenza
0360558	10/13/2009	MA	50.0	50		F	10/13/2009	hoarseness, coughing,immediately followed by significant constriction in throat and chest, with watering eyes.  Took 2 benadryl within 30 minutes of onset of symptoms and within another 30 minutes 2 puffs from inhaler ordered by PA friend.   Severe symptoms subsided, and rest of evening and following 2 days (so far) still having watery eyes and some itching / small hives.									Y	10/10/2009	10/10/2009	0		PUB	PUB		no	no			1						1	Chest discomfort; Cough; Dysphonia; Lacrimation increased; Pruritus; Throat tightness; Urticaria	FLUX~UNKNOWN MANUFACTURER~~1~ID~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360560	10/13/2009	MA	0.09	0	.1	M	10/12/2009	Baby's temperature slightly went up to 100.5 maximum about 11hrs following vaccine.									Y	10/08/2009				PUB	PUB		None	None			1						1	Body temperature increased	FLU3~SANOFI PASTEUR~U3262DA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360563	10/13/2009	DC	27.0	27		U	10/13/2009	Per Allergy note 9/23/09: Received the Influenza intramuscular injection in the left arm as well as pneumococcal intramuscular injection in the right arm on Wed, Sept 16th.  She states that during her waiting period of 15 minutes, she did not have any sxns.  However about 45 minutes post vaccination, she developed a sense of flushing and redness over her upper body, starting at her chest and rostrally to her head. She also had a sensation of mild pruritis initially.  She states that her sxns got progressively worse over the next 24-36 hrs.  48 hrs post vaccination, her sxns had progressed to facial erythema pruritis, and swelling.  She also felt she was having some tightness in her throat, and throat pain.  In addition, she began developing some SOB.  She saw her case manager, who recommended that patient go to the ER.  She did not initially go, but that afternoon around 1400 her sxns were to the point that she was seen in the ER (worsening SOB and throat tightness).  She was given BENADRYL and ZANTAC IV, as well as IV steroids.  She was noted to be wheezing per patient report and received ALBUTEROL x2.  She was observed for a few hours and discharged with PO BENADRYL 50mg q6hrs, po ZANTAC 150mg po bid, and PREDISONE 7 day taper.  That evening, she had a recurrence of SOB sxns, and was seen in the ER and received another dose of BENADRYL, steroids, and ALBUTEROL nebs x 3.  She did not receive Epinephrine.  She was discharged and instructed to continue her medications.  She states that her sxns did not progress from there, but gradually improved over the next 2 days, completely resolved 2 days ago.  She was seen yesterday by her PCM for continued throat pain and given TESSALON pearles.  Her air movement has improved, but she continues to use ALBUTEROL 2 x/day, previously not requiring any.  She describes slight heaviness of her chest.  She did not develop any abdominal sxns, dizziness, or neurologic sxns.  Her vaccine sites had mild erythema and tenderness, larger on the area of her pneumococcal vaccine. No hx of reactions to previous FLUMIST vaccines or previous IM flu vaccines.  No history of egg or gelatin allergies.  Symptoms: Pruritus, wheezing swelling (facial), dyspnea (shortness of breath), Odynophagia (burning pain w/swallowing, tightness in throat).				Y						09/16/2009	09/16/2009	0	9/23/09, Spirometry:  Effort - poor expiratory effort, FEV1 - 2.66/2, 74 post alb, FEV1%-85%/88% post alb, FVC-2.87/3.11 post alb, FVC %-81%/88% post alb, FEV/FVC% - 105%/100% post alb.  INTERPRETATION: No obstructive disease.  No reversibility with albuterol.  No flattening of inspiratory loop. Poor expiratory effort.	UNK	UNK		None	History Asthma: Diagnosed 3 yrs ago. Previously on ADVAIR, no current use.  ALBUTEROL use infrequent, last time was 3 months ago attributed to allergies.  Last asthma exacerbation was 5 months ago, also last ED visit.  Sxns of upper airway tightness while into a run, no cough or SOB at completion of exercise, no night time sxns, no interference with activities.  Allergic rhinitis:  April-May, Sept-Oct are worse sxns.  Nasal stuffiness, congestion, sneezing, eye pruritis and drainage.  Uses ZYRTEC and FLONASE as well assaline spray.  Also sxns around strong odors such as perfumes.   Hx of sinus infections, just completed 21 days of Augmentin 2 wks ago.  Scheduled ENT to have sinus CT.  Hx of psychotic break and anxiety, and is currently being Medically Separated.  Medication intolerance Vancomycin (local redness over injection site) PERCOCET (throat closing) REGLAN ?unknown.			1						1	Chest discomfort; Dyspnoea; Erythema; Flushing; Injection site erythema; Injection site pain; Odynophagia; Oropharyngeal pain; Pruritus; Spirometry abnormal; Swelling face; Throat tightness; Wheezing	FLU3~SANOFI PASTEUR~U3176AA~UNK~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0867X~UNK~~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0360568	10/13/2009	CA	80.0	85		F	10/13/2009	Itching spread next day some redness ans swelling warm to tocuh.									Y	10/13/2009	10/13/2009	0		UNK	UNK	NONE	none	none			1						1	Erythema; Pruritus; Skin warm; Swelling	FLU3~SANOFI PASTEUR~u3194aa~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360570	10/13/2009	UT	69.0	69		M	10/13/2009	Broke out with rash consistant with active herpes zoster on right T9 dermatome with pain and neuritis				Y					N	09/29/2009	10/02/2009	3	none	PVT	PVT	Trazedone, Zoloft, Lorezepam, Lisinopril	No	No			1						1	Herpes zoster; Neuritis; Pain; Rash	FLU3~SANOFI PASTEUR~U3188AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|VARZOS~MERCK & CO. INC.~0562Y~1~IM~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0360571	10/13/2009	TX	52.0	52		F	10/13/2009	Pt became nauseated with increased BP of 169/110 pulse 89 had dry heaves and refused ambulance. later went to ER				Y					U	10/11/2009	10/11/2009	0		UNK	UNK		none	none			1						1	Blood pressure increased; Nausea; Retching	FLU3~SANOFI PASTEUR~u3194aa~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360572	10/13/2009	MI	43.0	43		M		10/1/09 pt states got flu shot for 1st time, 10/08/09 seen in Dr's office, 10/09/09 admitted to hosp. 10/26/09 Hospital records received for dates 10/9/09 to 10/13/09. DC DX: postvaccinial transverse myelitis. Presenting SX: pt. seen in ER on 10/8 c/o 4 days after flu vax began sx. of tingling and paresthesias starting in feet and eventually all of lower extremities. Pt. c/o urinary retention, HA. Assessment: WNL, bladder scan WNL. Pt d/c and returned following day,  sx. progressively getting worse. Pt. admitted, diagnostics performed pt. tx. And d/c improved stable condition.				Y	Y	4			U	10/01/2009	10/05/2009	4	MRI 10/26/09 Hospital records received for dates 10/9/09 to 10/13/09 Diagnostics/Labs: MRI abnormal-T2 hyperintensities at several levels of thoracic spine. CXR(-), EKG(-), CSF WBC 120(H), CSF RBC 3400(H), CSF total protein >600(H), CSF protein 81(H), CSF cx(-), CSF ACE(-), CSF HSV, varicella, west nile all (-), CSF myelin basic protein 477(H), BUN 24(H), HGB 12.9(L), HCT 37.6(L).	OTH	PVT	AMITRIPTYLINE 25mg at bedtime & PRN in hospital; LOVENOX 40mg 1x daily	No	No 10/26/09 Hospital records received for dates 10/9/09 to 10/13/09 PMH: (+)TB test.			1						1	Myelitis transverse	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0360573	10/13/2009	TX	25.0	25		M	10/13/2009	Injection given 10/8/09 afternoon. That evening a rash developed to the back of his shoulders and back (more on left side) No rash to chest or arm at injection site. Rash worse on Friday. Felt hot with dry throat and never took temperature took Benadryl Sun. Feels better Monday and rash resolving. Small amount remains on back; shoulders clear.									Y	10/08/2009	10/08/2009	0	No	OTH	PVT	None	None	Outdoor / seasonal/ Allergies			1						1	Dry throat; Feeling hot; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97216~3~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360574	10/13/2009	MA	55.0	55		M	10/12/2009	Pt, had TDaP, flu and PPV23 given at 11:30AM 9/22/2009=> pt called PCP office around 5PM c/o severe vomiting and diahrrea. Pt very anxious and advised to go to ER. ER note from 9/22/09 at 6:30PM report s/s resolved.				Y						09/22/2009	09/22/2009	0		PUB	UNK			NKPA, HTN, hyperlipidemia, Right side CUA			1						1	Anxiety; Diarrhoea; Vomiting	FLU3~SANOFI PASTEUR~U3188AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~UF500AA~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1|TDAP~SANOFI PASTEUR~0823Y~UNK~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0360575	10/13/2009	PA	61.0	61		F	10/07/2009	Sever bilateral cramping in thighs, calves, shins & feet.  Started @ 4 PM -> at night bad.									Y	10/06/2009	10/06/2009	0		PVT	OTH	KCLOR-CON; DYAZIDE; ASA; PRAVOCHOL.		HTN.			1						1	Muscle spasms	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98441P1A~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360577	10/13/2009	PA	46.0	46		F	10/13/2009	Neurological sx-leg giving out-speech problems, nausea, weakness, fatigue.									N	10/08/2009	10/08/2009	0		PVT	OTH			KEFLEX, PCN, sulfa, CODEINE allergies			1						1	Asthenia; Fatigue; Muscular weakness; Nausea; Neurological symptom; Speech disorder	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98441P1A~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360578	10/13/2009		50.0	50		F	09/17/2009	Vaccinated with AFLURIA 2009-2010 formula noon 09/16/09. By early evening hard 4 inch x 2 inch by 1 inch swollen area on deltoid an upper arm left. Next AM swollen lymph node left clavicle area 3. 5x2. 25 inch. tender to touch. No fever. Same afility 3 others have reported arm reactions with soreness, redness and warmth post injection.									N	09/16/2009	09/17/2009	1	No prior history on any.	UNK	UNK						1						1	Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; Lymph node pain; Lymphadenopathy	FLU3~CSL LIMITED~0574911A~2~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360588	10/13/2009	CO	55.0	55		F	10/13/2009	I gave vaccine that was indicated for 2-49 years of age. The client was a 55 year old healthcare worker working in our jail. Client will inform us about possible adverse events.										10/13/2009				UNK	UNK		No	No			1						1	Inappropriate schedule of drug administration	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500751P~1~~~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA		Influenza
0360589	10/13/2009	NC	12.0	12		F	10/13/2009	Woke up in AM with swollen face and puffy eyes and serous nasal congestion  Treated with Clarinex 5 mg po in office to be given q day until swelling resolved									Y	10/08/2009	10/09/2009	1		PVT	PVT	AMITRIPTYLINE	NO	GERD			1						1	Eye swelling; Nasal congestion; Swelling face	FLUN3~MEDIMMUNE VACCINES, INC.~500715P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360591	10/13/2009	OH	40.0	40		F	10/13/2009	Couldn't wake up all day next day (Sat.). Slept on the floor while her child played. On 10/11 noted numbness in face and mouth to right shoulder. On 10/12 noted numbness and pain down right arm (shot given in left.) Began to have numbness left hand. Later, in ED, right arm became paralyzed. 11/9/09:  ED Records received for date of service 10/12/09:  Dx:  peripheral neuropathy  Assessment:  Presented with numbness of arms, fingers and mouth.  Normal reflexes, RUE weakness, no LUE weakness.  Had flu shot and  felt sick the next day:  dizzy, fatigue, slight sore throat. No lower extremity weakness.  Gait normal.  IV fluids given.  Appointment made to follow up in neurology clinic.			Y	Y					U	10/09/2009	10/11/2009	2	Patient was sent home looking better and with movement restored. Still has pain in right arm. 11/9/09:  ED Records received for date of service 10/12/09:  Labs and Diagnostics:  CRP < 0.3 (NL), Sed. rate 3 (NL), Urine HCG Negative, Urine blood 2+ (H), CBC (WNL), PT 11.8 sec (H), BMP (WNL).	UNK	UNK		None	None. 11/9/09:  ED Records received for date of service 10/12/09:  PMH:  NKDA			1						1	Hypersomnia; Hypoaesthesia; Hypoaesthesia facial; Hypoaesthesia oral; Monoplegia; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua454BA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Life Threatening	Influenza
0360592	10/13/2009	AZ	2.0	2	.8	M	10/13/2009	Diarrhea, runny nose sneezing.  10/12/2009 vomiting 9pm and 3am.									Y	10/08/2009	10/10/2009	2		PVT	PVT		none	none			1						1	Diarrhoea; Rhinorrhoea; Sneezing; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360593	10/13/2009	CA	60.0	60		F	10/13/2009	right after, shaking hands and unsteady feeling overall.  Next day, slight fever, broke next day in am.									Y	10/10/2009	10/10/2009	0		PUB	PVT		None	Penecillian			1						1	Balance disorder; Immediate post-injection reaction; Pyrexia; Tremor	FLUX~UNKNOWN MANUFACTURER~~1~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360594	10/13/2009	WI	80.0	80		F	10/13/2009	chills, muscle aches especially upper back and shoulders, H/A, slight nausea, earache, activated peripheral neuropathy, hardly able to stand. Contacted her cardiologist by phone and he felt that this was a reaction to the flu shot but not unexpected									Y	10/06/2009	10/07/2009	1		PUB	PUB	Metoprolol 25 mg 1/2 tab Bid, Corzaar 25 mg Bid, Coumadin 2 mg, low dose aspirin daily, Zocor 20 mg	Had flu like symptoms prior for 3 1/2 weeks	peripheral neuropathy, fibromyalgia, hypertension, heart disease			1						1	Chills; Condition aggravated; Dysstasia; Ear pain; Headache; Immunisation reaction; Myalgia; Nausea; Neuropathy peripheral	FLU3~SANOFI PASTEUR~U3192AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360595	10/13/2009	OH	13.0	13		M	10/07/2009	10/3/09 - Received FLUMIST @ noon.  Developed hives @ 4PM.  Benadryl given per mom.  10/4/09 - Only a few hives remained on patient's trunk.  10/5/09 - Resolved; no further hives.									Y	10/03/2009	10/03/2009	0		PUB	PUB						1						1	Urticaria; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500707P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500707P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA		Influenza
0360597	10/13/2009	OR	63.0	63		M	10/07/2009	Initial report received on 29 September 2009 from a health care professional. A 63 year old male patient with no reported past medical history developed redness at the site which blistered within 24 hours of receiving FLUZONE SV 2009-2010 (lot number U3216AA) intramuscularly in the left deltoid on 23 September 2009. One year prior, the patient had a influenza vaccine, but did not experience any reactions to the vaccine. Concomitant therapy included blood pressure and cholesterol medication (name of medication was not specified). On 24 September 2009, the patient also experienced redness to the left side of his chest, forehead, shoulders, and armpits which also turned to blisters. The patient was advised by the reporter to contact his primary care provider for treatment. The patient was seen in the emergency room on 29 September 2009 and was diagnosed with herpes virus outbreak. The patient was prescribed antiviral medication. No further information was provided. The patient did not recover. List of Documents held by Sender: none.				Y					N	09/23/2009			None reported	UNK	UNK	Blood pressure medication; Cholesterol medication		NKA		200904140	1						1	Blister; Erythema; Herpes virus infection; Injection site erythema; Injection site vesicles; No reaction on previous exposure to drug	FLU3~SANOFI PASTEUR~U3216A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360598	10/13/2009	IL				M	10/08/2009	Initial case was received from a physician on 01 October 2009. The physician, who is also the patient, reported two additional patients who experienced similar events following vaccination with FLUZONE. No identifiers were reported for the other two patients, and lot number for those patients was unknown. A male patient experienced pain and paresthesia after receiving a right arm injection of FLUZONE No Preservative 2009-2010 (lot number U3253CA) on 17 September 2009. Two days post-vaccination, on 19 September 2009, he developed paresthesia and pain in the right side of his body, from his armpit to his lower abdomen. At the time of the report, the events were still ongoing. According to the reporter, the other two patients experienced similar reactions. Documents held by sender: None.				Y					N	09/17/2009	09/19/2009	2		UNK	UNK			Not reported.		200904169	1						1	Pain; Paraesthesia	FLU3~SANOFI PASTEUR~U3253CA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360599	10/13/2009	CA	46.0	46		M	10/06/2009	Anaphylaxis 2 hours post injection with swollen tongue.  Patient taken to ER.  Patient reported to pharmacy on 10-5-09.				Y						09/17/2009	09/17/2009	0		OTH	PVT						1						1	Anaphylactic reaction; Swollen tongue	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2A~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360600	10/13/2009	OK	56.0	56		F	10/08/2009	Initial report received on 02 October 2009 from a consumer. A 56 year old female patient with a low thyroid and allergies to mold, ragweed, KEFLEX, and BACTRIM complained of congestion with lots of phlegm, ear congestion, watery, blurry eyes twelve hours after receiving FLUZONE SV (lot number not known) intramuscularly in the right deltoid on 25 September 2009. The patient stated that the vaccine appeared to be pink in color. On 27 September 2009 the patient went to the emergency room and was treated with PREDNISONE and ZITHROMAX. On 30 September 2009 the patient was seen again in the emergency room. No further treatment was given at that time. Concomitant therapy included herbals, bp meds, Synthroid, oils, and vitamins. Diagnostics included: EKG (results not provided), CT chest which revealed bronchitis (dates not specified). On 27 September the patient had a negative flu test. The patient's recovery status was unknown. List of Documents held by Sender: none.				Y					U	09/25/2009			EKG, CT chest which revealed bronchitis. On 27 September the patient had a negative flu test.	PVT	UNK	BP MEDS, HERBALS, VITAMINS, SYNTHROID		No illness at the time of vaccination. History of a low thyroid and allergies to mold, ragweed, KEFLEX, and BACTRIM.		200904176	1						1	Bronchitis; Computerised tomogram abnormal; Ear congestion; Electrocardiogram; Increased upper airway secretion; Influenza serology negative; Lacrimation increased; Respiratory tract congestion; Vision blurred	FLU3~SANOFI PASTEUR~~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360606	10/13/2009	UT	79.0	79		M	10/05/2009	Patient received the FlLULAVAL 2009-2010 flu shot on 9/22/2009. He developed shingles about 4 days later and was seen at the Clinic. He still had the rash on his arm, but it is getting better.										09/22/2009	09/25/2009	3		UNK	UNK			No other vaccinations given. No new medications started.			1						1	Herpes zoster; Rash	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLAZ61AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0360616	10/13/2009	ID	45.0	45		F	10/13/2009	12:39 pm- 0.5 cc Fluvarin seasonal vaccine injected IM into left deltoid. 12:40pm- Patient became very flushed, eyes watering, c/o do not feel well, headache. 12:41pm- Patient got weak and headache worsening, slowly laid down to floor. Administered 0.3 cc Epinephrine sub-q  deltoid. BP 120/80  pulse 100. 12:48 pm-  Patient c/o heavy chest, lungs clear, called 911 and requested ambulance. Pulse 92. 12:50pm-    Pink face (redness lessening), chest heaviness relieved. Pulse 89  SPO2 98%. 12:56 Ambulance/EMS arrived, SPO2 92%				Y					Y	10/12/2009	10/12/2009	0		UNK	UNK		none	none			1						1	Asthenia; Chest discomfort; Erythema; Flushing; Headache; Heart rate increased; Lacrimation increased; Malaise	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA261AA~1~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0360617	10/13/2009	CA	48.0	48		F	10/13/2009	One hour after administration injection site pain that radiated into armpit, 7/10, burning and sharp,lasted one hour. Then burning,pressure started to radiate across her chest to sternum and base of neck, uncomfortable sensation, lasted into next day. No shortness of breath or wheezing. No nausea or vomiting. No numbness or tingling. No itching or skin rash. Next day still symptomatic seen in urgent care. IV fluids and Toradol IV given,symptoms resolved in 3 hours.				Y					Y	09/30/2009	09/30/2009	0	ECG and CXR normal, cardiac enzymes normal, BP low, 117/68.	UNK	UNK	Ativan, Tramadol, Amitriptyline	No	Allergic Rhinitis-grass, tree and mold, no meds. Anxiety controlled with Ativan 0.5mg, not taken on the day of administration. Chronic pain secondary to arthritis and bursitis hips, prescription Tramadol 50mg tab as needed for pain, not taken on day of immunization. Insomnia prescription Elavil 10mg, 1-3 tabs, at bedtime, taken daily			1						1	Cardiac enzymes normal; Chest X-ray normal; Chest discomfort; Electrocardiogram normal; Hypotension; Injection site pain	FLU3~SANOFI PASTEUR~U3211AA~4~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360618	10/13/2009	MD	1.75	1	.8	F	10/13/2009	focal febrile seizure				Y					Y	09/30/2009	09/30/2009	0	EEG	PVT	UNK		none	none			1						1	Electroencephalogram; Febrile convulsion	FLUX~UNKNOWN MANUFACTURER~~2~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360622	10/13/2009	TN	22.0	22		M	10/12/2009	Received INFLUENZA A H1N1 FLU MIST 10-7-09, next day had N/V for short period of time.									Y	10/07/2009	10/08/2009	1		PUB	OTH	None	No	None			1						1	Nausea; Vomiting	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500754P~1~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA		Influenza
0360624	10/13/2009	AK	46.0	46		F	10/13/2009	sore arm; reddened injection site; complaint of inability to hold arm up. Employee saw personal physician; received steriod injection. Patient had an MRI performed it shows the left shoulder where the vaccination was given shows signs of inflammation.									N	09/23/2009	10/02/2009	9		UNK	UNK		none reported	none known			1						1	Injected limb mobility decreased; Injection site erythema; Injection site inflammation; Nuclear magnetic resonance imaging abnormal; Pain in extremity; Arthralgia; Mobility decreased; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA470CA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1|FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA470CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~2	USA		Influenza
0360625	10/13/2009	OH	6.0	6		F	10/13/2009	Chief complaint of mild nasal congestion and cough. Symptoms began about 3 days ago. Fever has been high-grade. Other associated symptoms include: nosiy breathing at night. High fever 3 days, bronchitis the fever and cough came after the vaccine.				Y						10/07/2009	10/07/2009	0		UNK	UNK		high fever 3 days, bronchitis	ENURESIS NOS  788.30   ATTN DEFICIT W HYPERACT			1						1	Breath sounds abnormal; Bronchitis; Cough; Nasal congestion; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500677p~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0360627	10/13/2009	TN	24.0	24		F	10/12/2009	Received H1N1 mist 10-7-09- started s/s of N/V- low grade temp that HS- improved next.									Y	10/07/2009	10/07/2009	0		PUB	OTH	None	None	None			1						1	Body temperature increased; Nausea; Vomiting	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500754P~1~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA		Influenza
0360628	10/13/2009	PA	31.0	31		M	10/12/2009	Seen at hospital ER for urticaria-told to take BENADRYL.				Y					U	10/01/2009	10/03/2009	2	None	PVT	OTH	ZOLOFT 100 mg qd; suboxone 8 mg 2 qd	None	None			1						1	Urticaria	FLU3~SANOFI PASTEUR~U3185AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360629	10/13/2009	WI	1.28	1	.3	M	10/12/2009	Rash and fever.									U	10/06/2009	10/07/2009	1	Clinic visit	PVT	PVT		No	No			1						1	Pyrexia; Rash	DTAP~GLAXOSMITHKLINE BIOLOGICALS~AC14B102BA~1~IM~LL~DTAP (INFANRIX)~1|FLU3~SANOFI PASTEUR~UT3176A~3~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF729AA~4~IM~RL~HIB (ACTHIB)~1	USA		Influenza
0360631	10/13/2009	CA	54.0	54		F	10/13/2009	24 hr flu symptoms, as well as pain in arm that has not gone away. Nurse hit a nerve when she administered the shot.  Pain lifting arm since.									N	09/24/2009	09/24/2009	0		UNK	UNK		NONE	NONE			1						1	Influenza; Injected limb mobility decreased; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~1~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360632	10/13/2009	VA	28.0	28		M	10/13/2009	on 10/8 - I gave pt these immunizations:  influenza in L arm, and pneumonia in R arm.  Adverse effect was noted in R arm. 10/09/09 pm:  I evaluated his arm - no erythema or edema noted at this time, but advised pt to f/u if s/sx of cellulitis appeared.  He did c/o limited mobility and pain in R arm.  10/10/09 am:  Pt went to PMD due to s/sx of cellulitis.  Given ABX (Keflex)				Y					Y	10/08/2009	10/08/2009	0		UNK	PVT						1						1	Cellulitis; Injected limb mobility decreased; Pain in extremity	FLU3~CSL LIMITED~08449111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~1134Y~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0360633	10/13/2009	VA	54.0	54		M	10/13/2009	Gave pt influenza in L arm and pneumonia in R arm on 9/29/09.  Pt came back to clinic on 10/2 with c/o pain in R arm.  Also had redness, warmth and edema - but not at immunization site.  He was immunized on lateral aspect of R arm, adverse effect appeared on medial aspect of R arm.				Y					Y	09/29/2009	10/01/2009	2	He went to PMD on 10/2/09 and was given an ABX.  Per the PMD, the ABX made the pt ill, so pt stopped taking the ABX after 1 dose.  PMD saw pt again on 10/5 and s/sx had resolved.  PMD saw pt on Friday	UNK	PVT			Irritable Bowel Syndrome Fibromyalgia			1						1	Erythema; Oedema; Pain in extremity; Skin warm	FLU3~CSL LIMITED~08449111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~1134Y~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA	Emergency room visit	Influenza
0360634	10/13/2009	CA	11.0	11		M	10/13/2009	Fever 100, dizziness, sore throat, confusion, headache.									U	10/07/2009	10/09/2009	2		UNK	UNK	NA	NONE	NONE			1						1	Confusional state; Dizziness; Headache; Oropharyngeal pain; Pyrexia	FLUX(H1N1)~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN))~1	USA		Influenza
0360636	10/13/2009	CT	75.0	75		M	10/13/2009	Severe chills (shivering) which lasted about 25 minutes. Bouts came in waves which each succeeding bout shorter than the previous. This was followed by a moderate temperature which lasted (+/-) 4 hours. I feel fine today, 10/13/2009. Has never happened before.									Y	10/12/2009	10/12/2009	0		PUB	UNK	Allopurinol  300 mg.  (one tab) aspirin 81 mg.  (one tab)	None	Coronary Artery Disease			1						1	Body temperature increased; Chills	FLUX~SANOFI PASTEUR~U3212AA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360637	10/13/2009	PA	4.0	4		M	09/01/2009	A non serious spontaneous report of runny nose, congestion, headache, chills, fever, vomiting and diarrhea has been received from a consumer/ mother concerning her four-year-old son, subsequent to FluMist. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The patient's medical history included birth at 37 weeks, tonsillectomy and adenoidectomy at 22 months and a urinary tract infection in April-2009. On 28-Aug-2009, prior FluMist vaccination, the patient had mild nasal congestion. He was not taking any concomitant medications and did not receive any other vaccines on the day FluMist was administered. The patient's brother experienced high fever and lethargy after receiving his first dose of DTAP at two-months-old and did not  experience any reactions after subsequent doses of Diphtheria and Tetanus Toxoid, pediatrics (DT) only. The patient received his first dose of FluMist on 28-Aug-2009 at 2:00.pm. On 30-Aug-2009, the patient awoke with nasal congestion and a runny nose. As the day went on he developed a headache, chills and fever. His mother treated him with Children's Acetaminophen. On 31-Aug-2009, his mother reported that he seemed better. She called her pediatrician's office and spoke to the head nurse about the events. During that call, the nurse informed her that the events were most likely related to the FluMist vaccination. On the evening of 31-Aug-2009, her son developed a fever, diarrhea and vomiting. His temperature was 101.3 degrees Fahrenheit. She treated him with Children's Ibuprofen. On 01-Sep-2009, his mother again called the pediatrician's office and spoke with the same nurses regarding the fever, diarrhea and vomiting he experienced on 31-Aug-2009. During the call on 01-Sep-2009, the nurse informed the patient's mother reported that her other children received FluMist the same day and did not experience any reactions and have not been sick. She added that she, her husband, his siblings and visiting grandparents who were around the patient did not get sick. The mother indicated she did not think she would have FluMist administered again. The events resolved.  Additional information was received on 14-Oct-2009 from the physician's office and incorportated into the narratives included confirmation that no other vaccinations were provided on the day FLUMIST was administered or within four weeks prior and that the patient was not taking any concomitant medications.									Y	08/28/2009	08/30/2009	2		PVT	PVT	Concomitant Drugs Not Used	Nasal Congestion	Born at 37 week; Tonsillectomy & Adenoidectomy; Urinary tract infections	Fever~DTaP (no brand name)~UN~0.20~Sibling|Lethargy~DTaP (no brand name)~UN~0.20~Sibling	MEDI0008822	1						1	Chills; Diarrhoea; Headache; Pyrexia; Respiratory tract congestion; Rhinorrhoea; Urinary tract infection; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500681P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360638	10/13/2009	TX	4.0	4		M	09/03/2009	A non-serious, spontaneous report of joint pain, muscle aches, left ear burning and fever has been received from a patient's father concerning his four year old son subsequent to Flumist. This case is submitted in accordance with manufacturer post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patients medical history was not reported. The patient received Flumist on 02-Sep-2009 as well as his four year old shots such as DTP, tetanus, MMR, polio, and chicken pox vaccines. On the night of 02-Sep-2009, the patient complained of joint and muscle pain.  Around 3 am on 03-Sep-2009, the patient ran a fever of 102.9 degrees. and in the morning of the same day his left ear was burning. The outcome of the events was not reported. All follow-up attempts have been made per company SOPs. No further information available. Per MI convetions, non - MI mfr not captured - queries 1-6.									U	09/02/2009	09/02/2009	0		OTH	OTH	Concomitant Drugs not reported		No information		MEDI0008836	1						1	Arthralgia; Burning sensation; Ear discomfort; Myalgia; Pyrexia	DTP~UNKNOWN MANUFACTURER~~UNK~UN~UN~DTP (NO BRAND NAME)~1|FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|IPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~POLIO VIRUS, INACT. (NO BRAND NAME)~1|TTOX~UNKNOWN MANUFACTURER~~UNK~UN~UN~TETANUS TOXOID (NO BRAND NAME)~1	USA		Influenza
0360639	10/13/2009	KY	4.0	4		F	09/04/2009	Stomach ache (Abdominal pain upper). Fever (Pyrexia). Sore throat (Oropharyngeal pain). Lethargic (Lethargy). A non-serious spontaneous report of lethargic, stomach ache, high fever, and sore throat has been received from a nurse concerning a 4-year-old female, subsequent to FluMist. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FluMist on 02-Sep-2009. The patient received a single dose before onset of the events. On 03-Sep-2009, the patient developed lethargy, stomach ache, high fever, and sore throat. The outcome and causality were not reported.									U	09/02/2009	09/03/2009	1		PVT	OTH	Concomitant Drug(s) Not Reported				MEDI0008839	1						1	Abdominal pain upper; Lethargy; Oropharyngeal pain; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~UN~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360640	10/13/2009	IN	3.0			M	09/09/2009	Inappropriate schedule of vaccine administered (Inappropriate schedule of drug administration). A non-serious spontaneous report of administration of FLUMIST 12 days apart was received from a patient parent concerning a 36-month-old male subsequent to the administration of FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history or concomitant medications were reported. The patient received FLUMIST 12 days apart, first on 27-Aug-2009 and then inadvertently on 08-Sept-2009. There was no adverse event associated with this medication error, therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved.   All follow-up attempts have been made per company SOPs.  No further information is available. 08 Mar 2010.									Y	08/27/2009	08/27/2009	0		OTH	OTH					MEDI0008848	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360641	10/13/2009	NC				U	09/10/2009	A non-serious spontaneous report of FluMist administration to a child on aspirin has been received from a physician concerning a child subsequent to FluMist. On unknown date, FluMist was given to a child on chronic aspirin therapy. The patient's medical history was not reported. On 21-Sep-2009, the reporter confirmed there were no adverse events after FluMist administration. There was not adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with the post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.   All follow-up attempts have been made per company SOPs.  No additional information available.									Y					OTH	OTH	Aspirin				MEDI0008853	1						1	Vaccination error	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360642	10/13/2009	OH	2.0			F	09/11/2009	A non-serious, report of administration of TIV and 1 week later FLUMIST in a 24-month-old female patient was received from a nurse. On 04-Sep-2009 the patient received a flu shot and on 11-Sep-2009, received FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMISTS.									Y	09/11/2009	09/11/2009	0		PVT	OTH	Concomitant Drugs(s) Not Reported				MEDI0008857	1						1	Medication error; Unevaluable event	FLUN3~MEDIMMUNE VACCINES, INC.~500711P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360643	10/13/2009	NC	53.0			M	09/11/2009	A spontaneous, non-serious report of back and chest pain has been received from a other involving a patient (demographics unknown) subsequent to FLUMIST use. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 10-Sep-2009, the patient received FLUMIST. Hours later, he was experienced back and chest pain. No further information was available. The outcome of the events, back and chest pain, was unknown. All follow-up attempts have been made per company SOPs. No further information is availbale.									U	09/10/2009	09/10/2009	0		OTH	OTH	Concomitant Drugs(s) Not Reported				MEDI0008862	1						1	Back pain; Chest pain	FLUN3~MEDIMMUNE VACCINES, INC.~512545T~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360644	10/13/2009	KS	3.3			M	09/11/2009	A non-serious spontaneous report of not being able to sleep, fever, gagging and cough has been received from a consumer concerning a three-year-old female, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's pos-marketing commitment on accelerated reporting for the newly indicated population of 2years to 59 months of age for FLUMIST. The only medical history reported identifies the child as being pre-asthmatic. The patient received FLUMIST on 08 Sep 2009. The day after receiving FLUMIST the child experienced not being able to sleep, fever, gagging and cough. The primary care physician recommended she continue breathing treatment at home. After three days the symptoms have not resolved. All follow up attempts have been made per company SOPs.  No further information is available. 08 Mar 2010.									Y	09/08/2009	09/09/2009	1		OTH	OTH	Concomitant Drug (s) Not Reported		Pre-asthmatic		MEDI0008867	1						1	Cough; Insomnia; Pyrexia; Retching	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360645	10/13/2009	MA				F	09/14/2009	A non-serious spontaneous report of muscle pain, fever, and stomach pain has been received from a consumer, patient's parent, concerning a female child, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not provided. The patient received one dose of FLUMIST on 09-Sept-2009. The patient experienced muscle pain, fever, and stomach pain on 12-Sept-2009. The patient was taking acetaminophen, and her body temperature was 102.5. The outcomes of the events were not provided. 1-3 All follow-up attempts have been made per our SOPs.  Information is not available.  19-Feb-2010.									U	09/09/2009	09/12/2009	3		OTH	OTH					MEDI0008870	1						1	Abdominal pain upper; Body temperature increased; Myalgia; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360646	10/13/2009	OK	4.0			F	09/16/2009	A non-serious spontaneous report of generalized urticaria has been received from a physician concerning a four-year-old female, subsequent to FLUMIST use. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 15-Sep-2009. On 16-Sep-2009, about 24 hours after administration of FLUMIST the patient developed generalized urticaria. Outcome and causality were not reported. All follow-up attempts have been complete per company SOP.  No further information available. 10-Mar-2010.									U	09/15/2009	09/16/2009	1		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0008888	1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360647	10/13/2009	LA	4.0	4		F	09/17/2009	A non-serious spontaneous report of influenza type B was received from a consumer concerning a four year old female, subsequent to FluMist. The patient's past medical history and concomitant medications were not reported. The patient received FluMist on 14-Sep-2009. On 16-Sep-2009 the patient developed a running fever of 101.9 with some sneezing and a runny nose. The patient was tested at the physician's office and was positive for influenza type B. The outcome and causality of the event were not reported.  All follow-up attempts have been made per company SOPs.  No further information is available. 19-Feb-2010.									N	09/14/2009	09/16/2009	2		UNK	UNK	Concomitant drug(s) not reported				MEDI0008891	1						1	Influenza; Influenza serology positive; Pyrexia; Rhinorrhoea; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360648	10/13/2009	LA	2.0	2	.9	F	09/17/2009	A non serious spontaneous report of influenza type B was received from a consumer concerning a 34 month old female, subsequent to Flumist. The patient's past medical history and concomitant medications were not reported. The patient received Flumist on 14-Sep-2009. ON 16-Sep-2009 the patient developed a running fever of 101.7 degrees Fahrenheit with some sneezing and a runny nose. The patient was tested at the physician's office and was positive for influenza type B. The outcome of the event was not reported.									U	09/14/2009	09/16/2009	2		OTH	OTH	Concomitant drugs not reported		No information		MEDI0008895	1						1	Influenza; Pyrexia; Rhinorrhoea; Sneezing	FLUN3~MEDIMMUNE VACCINES, INC.~500693P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360649	10/13/2009	NY	2.0	2	.1	F	09/18/2009	A non-serious spontaneous report of pneumonia has been received form a consumer/father concerning his 25-month-old daughter, subsequent to FLUMIST. The patient's medical history and concomitant medication were not reported. The patient received FLUMIST on 16-Sep-2009. After receiving FLUMIST, the patient experienced a fever of 102 degrees Fahrenheit, runny nose and cough on an unspecified date. On 18-Sep-2009, she was experiencing a fever of 104 degrees Fahrenheit and was taken to her doctor for evaluation. Per the patient's father, his daughter was diagnosed with pneumonia. She was at home at the time of the report. The pneumonia and fever were ongoing. The outcome of runny nose and cough were not reported. All follow-up have been completed per company SOPs.  No further information is available.  10 Mar 2010.									N	09/16/2009	09/18/2009	2		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0008901	1						1	Cough; Pneumonia; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360650	10/13/2009	CT	2.0			M	09/18/2009	A non-serious, spontaneous report of rash, fever, and very irritable has been received from a physician concerning his 24-mouth-old son subsequent to FluMist. This case is submitted in accordance with the manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The patient's medical history and concomitant medications were not reported. The patient received FluMist on 04-Sep-2009. Not long after receiving FluMist, the patient contracted rash, fever and was irritable. As of 18-Sep-2009, only the symptoms of irritability exist at time in the child. The rash and fever resolved. All follow-ups have been completed per company SOP.  No further information available.									N	09/04/2009				OTH	OTH	Concomitant drug(s) not reported				MEDI0008908	1						1	Irritability; Pyrexia; Rash	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360651	10/13/2009					M	09/21/2009	A non-serious spontaneous report of runny nose has been received from a registered nurse concerning a male child, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medication were not provided. The patient received a total of one dose of FLUMIST on 07-Sep-2009. The patient's mother reported that he has had a runny nose since he was administered FLUMIST on 07-Sep-2009. The patient's was rubbing his nose so much that he was getting a rash under the nostril area. As of 21-Sep-2009, the event was ongoing. All follow-up attempts have been made per company SOP.  No further information is available.  19-Feb-2010.									N	09/07/2009	09/07/2009	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0008912	1						1	Rash; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360652	10/13/2009	FL	0.8	0	.8	U	09/22/2009	A non-serious spontaneous case of FluMist administered to a nine-month-old was received from a registered nurse concerning a nine-month-old infant. There was no adverse event associated with vaccination error therefore, treatment and causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing committment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.									Y	09/01/2009	09/01/2009	0		PVT	PVT	Concomitant Drug(s) Not Reported				MEDI0008923	1						1	Vaccination error	FLUN3~MEDIMMUNE VACCINES, INC.~500675P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360653	10/13/2009	MO	4.0	4		M	09/23/2009	A non-serious spontaneous report of fever and vomiting has been received from a registered nurse concerning a four-year-old male subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history nor concomitant medications were provided. The patient received FLUMIST on 17-Sep-2009. On 21-Sep-2009, the patient experienced a fever of 101.4 and vomiting.  No outcome was provided.  The events resolved on 22-Sep-2009.  Additional information was received on 14-Oct-2009 and incorporated into the narrative: outcome and patient's date of birth.									Y	09/17/2009	09/21/2009	4		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0008927	1						1	Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500688P~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360654	10/13/2009	NY	25.0	25		M	10/13/2009	itchy eyes and throat with non productive cough  1st time receiving flu vaccine									Y	10/12/2009	10/12/2009	0	None	PVT	PVT	Amoxicillin; Motrin	Dental infection	None			1						1	Cough; Eye pruritus; Throat irritation	FLU3~CSL LIMITED~01449211A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360655	10/13/2009	FL	65.0	65		F	10/13/2009	Shoulder and arm soreness, could not lift arm above waist.  Took some tynenol and put icy hot on my arm and shoulder.										10/10/2009	10/11/2009	1		UNK	UNK		no	no			1						1	Injected limb mobility decreased; Musculoskeletal pain; Pain in extremity	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~88433PI~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1286x~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360656	10/13/2009	UT	8.0	8		F	10/13/2009	10/09/09 4:00PM H1N1 Vaccine (Live, Attenuated) nasal spray administered.  10/10/09 Upon waking at 7:00AM noted coughing and sore throat. Temp. 99 range  10/11/09 Continued coughing and sore throat with hoarseness and diarrhea. Temp. 99 range.  10/12/09  Coughing, sore throat, hoarseness, diarrhea, with nasal congestion and runny nose. Temp.99 range  10/13/09  Cough has worsened and slightly productive, nasal congestion has worsened.  Temp. 99 range.  The following symptoms have subsided: sore throat and hoarseness.  A visit to her doctor today as a precautionary.  Continue to monitor symptoms.										10/09/2009	10/10/2009	1		PUB	UNK	No	No	No			1						1	Body temperature increased; Cough; Diarrhoea; Dysphonia; Nasal congestion; Oropharyngeal pain; Productive cough; Rhinorrhoea	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500751P~UNK~~~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA		Influenza
0360657	10/13/2009	CT	58.0	58		M	10/13/2009	Client flew home Thurs evening.  Client states rash/itching to feet started 10/08/09 in the evening, then radiating rash upwards towards legs, change in voice. Was seen in ER, treated for allergic reaction, possibly to Thimerisol.  Started on Prednisone and antihistamines.				Y					N	10/07/2009	10/08/2009	1	Currently being worked up with Allergist office, Endocrinologist office.  Patient will forward lab results to the health unit.	UNK	UNK	Simvasatin, Hydrotherazine, Glipizide, Actos	No illness reported on day of vaccination.  Between 24-48 hrs after vaccination, experienced rash/itching to feet, radiating upwards to legs, experienced change in voice.	Type 2 Diabetes, HTN,			1						1	Dysphonia; Hypersensitivity; Laboratory test; Rash pruritic	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98435P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360658	10/13/2009	MO	2.0			F	09/24/2009	A non-serious spontaneous report of rash and swelling around nose and face has been received from a nurse practitioner concerning a 24-month-old female patient subsequent to receiving FluMist. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Medical history and concomitant medications were not reported. On 24-Sep-2009, the patient received FluMist. A few hours after receiving FluMist, the patient developed a rash and swelling around the nose and face. No further information was provided. The outcome of the events, rash and swelling around nose and face was unknown. All follow-up attempts have been completed per company SOP.  No futher information available.  10 Mar 2010.									U	09/24/2009	09/24/2009	0		PVT	OTH	Concomitant drug(s) not reported				MEDI0008940	1						1	Rash; Swelling face	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360659	10/13/2009	CA	14.0	14		F	10/13/2009	dizziness, severe headache, nausea, vomiting 10/16/09 Medical records received for dates 10/12/09 to 10/15/09. Symptoms: Pt received vaccine 10/12/09 parent called MD office to state approx. ½ hour after vaccine pt. c/o dizziness, diarrhea, HA, vomiting 2-3x, syncope. F/u appt. 10/15/09 c/o stomach issues, HA, nausea. Decreased appetite continued. Assessment: Mild TTP LLQ, referred to GI specialist. Pt has HA if overeacts then vomits, stress worsens problem. DX: Possible reaction to vaccine. Chronic abdominal pain, chronic HA.				Y						10/12/2009	10/12/2009	0		UNK	UNK		None known	10/16/09 Medical records received for dates 10/12/09 to 10/15/09 PMH: Abdominal pain at 3 y/o. Endoscopy at 5 y/o.(-).			1						1	Dizziness; Headache; Nausea; Vomiting	FLUX~SANOFI PASTEUR~U3198AA~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|HPV4~MERCK & CO. INC.~13164~3~IM~RA~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0360661	10/13/2009	AZ	43.0	43		F	10/13/2009	Starting at 6 am 5 days after receiving the flu vaccine, employee experienced sor throat, low grade fever, chest congestion, coughing, chills, and burning eyes. The same day vaccine was administered she developed soreness in the right upper arm where her injection was given. These symptoms had improved but not resolved as of 10/12/2009.				Y					Y	09/30/2009	10/05/2009	5	None	UNK	UNK	None	None	Mitral Valve Prolapse Alergy to sulfa drugs 01/12/2010 PMH: Asthma, pneumothorax, cholecystectomy, hysterectomy, smoker, allergy to Sulfa (skin rash/hives).			1						1	Chills; Cough; Eye irritation; Injection site pain; Limb discomfort; Movement disorder; Musculoskeletal disorder; Oropharyngeal pain; Pyrexia; Respiratory tract congestion	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA468CA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0360662	10/13/2009	PA	46.0	46		F	10/13/2009	Wednesday evening -- about  6 hours after I received the flu vaccine, I started feeling &#8220;itchy&#8221;.  I went to bed and the next morning I was covered in hives  and had felt  &#8220;shaky&#8221;.  I had hives on my neck,  both arms, trunk, and both legs .  Nothing near the injection site. I took Benadryl.   From work that day, I contacted the administrator of the vaccine and talked to a nurse who told me to continue taking Benadryl and if my throat would start to close or I had shortness of breath, to go to the emergency room.   I continued to take the Benadryl.  The next morning  (Friday) my hives were worse. There were more of them and they were bigger.  Especially on both wrists.  They were extra thick on the inside of both wrists&#8212;about 4 inches long and &frac12; in wide.   The hives were more itchy and I feel more &#8220;shaky&#8221; and nervous.  The hives on my wrists were very thick, and swollen.  They were very painful.  The swelling seemed to cut off circulation to my hands and my hands were cold.  The hives  were warm to the touch.   I went to work, continuing to take the Benadryl.  The Benadryl did not seem to help.  The symptoms were continually getting worse.  I left work  at 10:30 to see a doctor.  By 11 am I was at the doctors office and I explained that I was having an allergic reaction to a flu vaccine.  This was about   45 hours after the vaccine.  With severe symptoms of an allergic reaction, I was given an injection of  DepoMedrol  80 mg IM.    I was also given a prescription of Loratadine 10 mg.    Within an hour of the DepoMedrol  shot,  the worst  hives  (on my wrists)  started to become less painful .  The &#8220;shakiness&#8221; that I was having went away.   Over  the next several hours,  and into the evening, the hives got lighter in appearance.   The next day,  Saturday ,  there was more improvement .   The next day , today (Sunday)  still more improvement.   You can still tell where the hives were &#8211;the areas look like light colored bruises.  There is some slight itchiness in hands and feet each day since but Benadryl  helps.    I am not allergic to eggs.     This was my first flu vaccine.    Needless  to say, I will not get a vaccine next year.				Y						10/07/2009	10/07/2009	0		UNK	UNK		No	2 days prior to vaccine, I took the last of a ten day perscription for amoxicillin  500 mg for a ear infection.  The infection was cleared up.			1						1	Contusion; Hypersensitivity; Nervousness; Pain; Peripheral coldness; Pruritus; Skin warm; Swelling; Tremor; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA456AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0360664	10/13/2009	NJ	49.0	48		M	10/13/2009	Sore arm, chills, slight fever, aches, stiff neck, diarrhea x 3 days.									Y	10/06/2009	10/07/2009	1		PUB	PUB		None known.	None known.			1						1	Chills; Diarrhoea; Musculoskeletal stiffness; Pain; Pain in extremity; Pyrexia	FLU3~SANOFI PASTEUR~U3199AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360666	10/13/2009	OK	63.0	63		F	10/13/2009	injection site swollen, red, hot to touch, approx size of silver dollar, no knot per rn										10/07/2009	10/09/2009	2		UNK	PVT		no	unknown			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960326p~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360667	10/13/2009	AR	0.5	0	.5	F	10/13/2009	ACT HIB VACCINE MIXED INCORRECTLY WITH STERILE DILUENT FROM MERCK. VERIFIED WITH MEDICAL DIRECTOR AT SANOFI THAT THIS DOSE WAS NOT INVALID AND THAT STERILE DILUENT CAN BE USED IN PLACE OF ACT HIB DILUENT.										10/08/2009	10/08/2009	0		PVT	PVT						1						1	Wrong technique in drug usage process	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~AC21B208BA~UNK~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~U3261AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HIBV~SANOFI PASTEUR~UF596AB~UNK~IM~LL~HIB (ACTHIB)~1|PNC~PFIZER\WYETH~D88184~UNK~IM~RL~PNEUMO (PREVNAR)~1	USA		Influenza
0360668	10/13/2009	CO	4.0			F	09/25/2009	A non-serious report of Influenza has been received from a pharmacist concerning a four-year old female subsequent to FLUMIST. This case is subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reported for the newly indicated population of 2 years to 59 months of age of FLUMIST. The patient's medical history and concomitant medications were not provided. The patient received a total of one dose of FLUMIST on 23-Sep-2009. The patient experienced the event of Influenza, fever, runny nose, and positive flu test, on 25-Sep-2009. She was treated with oseltamivir phosphate. Outcome of the event is unknown. All follow-up attempts per company SOPs have been completed.  No further information is available.  19-Feb-2010.									U	09/23/2009	09/25/2009	2		OTH	OTH	Concomitant Drug(s) Not Reported.				MEDI0008941	1						1	Influenza; Influenza serology positive; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360669	10/13/2009	IN	1.92	1	.9	M	09/28/2009	A non-serious spontaneous report of administration of FLUMIST to 23-month-old was received from a nurse practitioner, In the USA, involving a 23-month-old male. ON 25-Sep-2009, the patient received FLUMIST. There is no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.									Y	09/25/2009	09/25/2009	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0008955	1						1	Vaccination error	FLUN3~MEDIMMUNE VACCINES, INC.~500707P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360670	10/13/2009		2.0			U	09/25/2009	A non-serious spontaneous report of severe projectile vomiting and fever has been received from a registered nurse concerning a 24-month-old patient of unknown sex subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST along with Hepatitis A vaccine an unknown date. The patient received a total of one dose of FLUMIST before the onset of the event. The patient experienced severe projectile vomiting and fever five hour after FLUMIST and Hepatitis A vaccine administration. The symptoms of severe projectile vomiting lasted approximately four hours. The events of severe projectile vomiting and fever were resolved. Reporter assessed the events of severe projectile vomiting and fever as related to FLUMIST and Hepatitis A vaccine. All follow up attempts have been completed per company SOP's.  No further information is available. 19-Feb-2010.									Y					MIL	OTH	Concomitant Drug(s) Not Reported				MEDI0008959	1						1	Pyrexia; Vomiting projectile	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~UNKNOWN MANUFACTURER~~UNK~UN~UN~HEP A (NO BRAND NAME)~1	USA		Influenza
0360671	10/13/2009	IN				M	09/30/2009	A spontaneous, non-serious report of administration of FluMist six days apart was received from a registered nurse concerning a male child (age unknown). Medical history and concomitant medications were not reported. On 23-Sep-2009, the patient received FluMist at a physician office. Six days later, on 29-Sep-2009, the patient received another dose of FluMist at school. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. All follow-up attempts have been completed per company SOP's.  No further information is available. 19-Feb-2010.									Y	09/23/2009	09/29/2009	6		OTH	OTH	Concomitant drug(s) not reported				MEDI0008969	1						1	Inappropriate schedule of drug administration; Medication error	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360672	10/13/2009	ID	1.93	1	.9	M	09/30/2009	Vaccination error (Vaccination error). A non-serious spontaneous report of FluMist administration to 23-month old was received from a non health-care professional in the United States concerning a 23-month-old male.  The patient was administered FluMist. There was no adverse event associated with this inappropriate age administration: therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.									Y	09/29/2009	09/29/2009	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0008970	1						1	Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500693P~UNK~~~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360673	10/13/2009	CA	52.0	52		M	10/13/2009	Headaches, tired, requiring excessive sleep of over 10 hours, normal sleep ranges from 6 to 7. Reported to clinic by wednesday, by Saturday was dealing with muscle weakness, at times between sleep and alertness, almost felt like I was paralyzed. Could not lift arms, make fist, and could only roll over to adjust discomfort, then the tiredness part set it, over 12 hours of sleeping, tiredness and lathargy.  Was fine for about five days, then symptons reappeared yesterday.									U	08/28/2009	08/28/2009	0	I am not sure if this is over.	UNK	UNK		prediabetic, BS Count up to 300 under control with diet and down under 120	Allergies that have not been a problem for over 2 years.			1						1	Fatigue; Headache; Hypersomnia; Immobile; Lethargy; Muscular weakness	FLUX~UNKNOWN MANUFACTURER~~1~IJ~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360674	10/13/2009		4.0			F	09/30/2009	A non-serious spontaneous report of threw up has been received from a consumer, patient's mother, concerning a four-year-old female subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  The patient's medical history and concomitant medication were not reported. The patient received a total of one dose of FLUMIST before the onset of the event on 29-Sep-2009. The patient threw up mostly phlegm, about two-three minutes after FLUMIST administration of 29-Sep-2009. The outcome of the event was unknown. All follow-up attempts have been completed per company SOPs.  No further information is available. 19-Feb-2010.									U	09/29/2009	09/29/2009	0		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0008972	1						1	Increased upper airway secretion; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~~UN~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360675	10/13/2009	TX	69.0	69		M	10/13/2009	Redness at site of injection. Prolonged (one week) soreness in upper arm, shoulder and elbow.  Mild headache. Fatigue.  Decreased stamina.									U	10/06/2009	10/06/2009	0	none	UNK	UNK	none	none	allergic to PCN, Codeine			1						1	Arthralgia; Fatigue; General physical health deterioration; Headache; Injection site erythema; Musculoskeletal pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360676	10/13/2009	FL	4.0			F	09/30/2009	A non-serious spontaneous report of fever, aches, weakness, a runny and congested nose, and cough has been received from a nurse concerning a 4-year-old female, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient.  On 24-Sep-2009, the patient received FLUMIST. The patient received a single dose before onset of the events. Two days after receiving FLUMIST, the patient developed fever, aches, weakness, a runny and congested and, more recently a cough. Outcome and causality were not reported.									U	09/24/2009	09/26/2009	2		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0008981	1						1	Asthenia; Cough; Nasal congestion; Pain; Pyrexia; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500711P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360677	10/13/2009	KS				U	09/30/2009	A non-serious, spontaneous report of administered full dose in one nostril in child patient was received from a medical assistant. There was no adverse event associated with this mediation error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing concomitant on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.   All follow-up attempts have been completed per SOP.  No further informaiton is available.  10-Mar-2010.									Y	09/30/2009	09/30/2009	0		OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0008982	1						1	Medication error; No adverse event	FLUN3~MEDIMMUNE VACCINES, INC.~~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360678	10/13/2009	IN	4.0	4		F	09/30/2009	A spontaneous, non-serious report of type B influenza has been received from a certified medical assistant concerning a four-year-old female patient subsequent to FLUMIST use. Medical history and concomitant medications were not reported. On or about 27-Sep-2009, the patient received FLUMIST. On 30-Sep-2009, the patient presented to the doctor's office with a fever of 101 degrees Fahrenheit. She tested positive for type B influenza. No further information was available.									U	09/27/2009	09/30/2009	3	Influenza type B, 09/30/2009, positive	OTH	OTH	Concomitant Drug (s) Not Reported				MEDI0008983	1						1	Influenza; Influenza serology positive; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500675P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360679	10/13/2009	VA	9.0	9		M	10/13/2009	fever, fatigue, weakness				Y						10/12/2009	10/12/2009	0		PVT	PVT		No	No			1						1	Asthenia; Fatigue; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500711P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0360681	10/13/2009	UT	25.0	25		F	10/13/2009	Migraine with auras									Y	10/13/2009	10/13/2009	0		PVT	PVT	Ambien, Seasonique	No	Asthma			1						1	Aura; Migraine	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360682	10/13/2009	CO	2.0	2	.4	F	10/13/2009	Increased tiredness and low grade fever that over next 24 hours worsened.  Fever peaked at 105.8 F on 10/5/2009 at 6:00pm.									Y	10/01/2009	10/02/2009	1	None, however was told by on-call MD to take pt to ED for LP, urine cx, and blood cx if fever did not decrease.	UNK	UNK		None	Environmental allergies to cats and grasses/weeds			1						1	Fatigue; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~1~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360683	10/13/2009	FL	83.0	83		M	10/13/2009	Severe itching, mostly the legs. High fever 102 degrees, Aches and shivering lasting 2 days				Y					Y	10/07/2009	10/07/2009	0		UNK	PUB		No	No			1						1	Chills; Pain; Pruritus; Pyrexia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~96032~4~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360684	10/13/2009	OK	27.0	27		F	10/13/2009	Hives and itching to arms and chest. Benadryl 50mg po given with improvement of symptoms until the following day when she blistered on arms and face. Went to physician who diagnosed shingles secondary to allergic reaction to seasonal flu vaccine.				Y					U	10/06/2009	10/06/2009	0	None that I am aware of.	PUB	UNK	Medication for Diabetes but unknown to what it is.	None	Diabetes Mellitus Type II			1						1	Blister; Herpes zoster; Hypersensitivity; Pruritus; Urticaria	FLU3~SANOFI PASTEUR~U3202AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360685	10/13/2009	WV	51.0	51		F	10/13/2009	Complaint of bruising, redness and swelling injection site.  Seen at local hospital and given anti-inflammatory injection per patient				Y					Y	09/16/2009	09/17/2009	1		PUB	PVT		none				1						1	Injection site erythema; Injection site haematoma; Injection site swelling	FLU3~GLAXOSMITHKLINE BIOLOGICALS~aflua470BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0360686	10/13/2009	CA	31.0	31		M	10/13/2009	Rapid onset of fever 103.7 orally, headache, dry heaves, took two extra strenght Tylenol 1000 mg. 3L fluids over three hours, water and tea, bed rest. Fever broke @ 2300 excessive sweating fever did not return, temp @ 1430 98.9. No appetite, dry heaves during fever, after fever broke tired and went to bed									Y	10/12/2009	10/12/2009	0	None	UNK	PVT		None	Allergic to Bee Stings Lung surgery as infant, birth defect, a tumor on lung, benign Hx of pnuemonia 10/2008, previously 1999 & 2001			1						1	Decreased appetite; Fatigue; Headache; Hyperhidrosis; Pyrexia; Retching	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98441P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360688	10/13/2009	OH	48.0	48		M	10/13/2009	Sore arm at first. Then, began feeling achy in arms, shoulders, neck, head, and back. By about 10:30, achiness spread to entire body and bad enough to take Tylenol.  By 1:00 a.m., aches were severe throughout my entire body.  I am a healthy, active person, but that night I was absolutely miserable. Felt like I had been hit by a train.  As achy as I've ever felt throughout entire body. Called in sick to work at 6:00 a.m.  Took ibuprofen, which helped a little.  No other symptoms except severe aches from head to toe.  By late afternoon, symptoms began to subside.  Very mild by about 10:00 p.m.  Next morning I felt perfectly normal. This was my first ever flu shot.									Y	10/05/2009	10/05/2009	0	none	PVT	PVT		No	No			1						1	Pain; Pain in extremity	FLUX~UNKNOWN MANUFACTURER~~1~IM~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360689	10/13/2009	CA	50.0	50		F	10/13/2009	Burning and stinging at injection site which turned to soreness. Unable to sleep on her left arm. Note 1cm by 1cm palpable mass at injection site.									Y	09/22/2009	09/22/2009	0	None	UNK	UNK	unknown	None.	None known			1						1	Injection site mass; Injection site pain; Insomnia	FLU3~CSL LIMITED~06649111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360690	10/13/2009	NE	73.0	73		F	10/13/2009	Sudden onset of fever, chills, body aches, vomiting, shortness of breath.				Y					Y	10/08/2009	10/09/2009	1	chest x-ray blood tests, flu test, oxygen, anti-vomiting medication IV saline solution	UNK	UNK	Enderal 80 mg longlasting Calcium Vitamin C Lisinopril 12.5 mg. One a Day Womens multi vitamin	No	None			1						1	Blood test; Chest X-ray; Chills; Dyspnoea; Influenza serology; Pain; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360691	10/13/2009	CA	5.0	5		F	10/13/2009	hives - mild without target lesions or mucosal involvement. Patient also on D6 of sulfa-medication. Supportive treatment (OTC benadryl) advised.										10/05/2009	10/13/2009	8		PVT	UNK	TRIMETHOPRIM-SULFAMETHOXAZOLE 40-200 MG/5 ML ORAL SUSP  Sig:  TAKE ONE AND ONE-HALF TEASPOONFULS ORALLY 2 TIMES DAILY FOR 10 DAYS  Started 10/05/2009	UTI -- patient placed on sulfa-medication on same day	Healthy ex 25-26 week preemie			1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500677P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB336BA~2~IM~RL~HEP A (HAVRIX)~1	USA		Influenza
0360692	10/13/2009	WA	48.0	48		F	10/13/2009	Began with post-nasal drip, then headache, sneezing.  Over next 30 hours, progressed to severe headache with aches across chest and arms, nausea, 'adrenaline rush' sensation with tightening of chest and asthma symptoms-short of breath, cough, continued tight-chested feeling. So far, this has lasted through today, 10/13 at 1700.  I will be seeing my own PCP tomorrow as symptoms have persisted.				Y						10/10/2009	10/10/2009	0		UNK	UNK	None prior to vaccine.	None	Very mild asthma that hasn't bothered me for the last 3 years or so, as long as allergies are kept under control.  I had no symptoms until receiving the vaccination.			1						1	Asthma; Chest discomfort; Condition aggravated; Cough; Dyspnoea; Headache; Nausea; Pain; Postnasal drip; Sneezing	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500764P~1~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA	Emergency room visit	Influenza
0360693	10/13/2009	MN	64.0	64		M	10/13/2009	Patient awoke with a high degree of dizziness (feeling as though the room was spinning), nauseous, and soaking wet (as in a hot flash). For the next two days he could hardly get out of bed due to dizziness and then feeling nausea if he tried to get up. He had no fever. On the third day he was up for awhile, but the dizziness continued to be intense for at least 7 days. I am writing this 2 weeks after the vaccine was received, and he still reports dizziness when he leans over quickly.									U	09/29/2009	09/30/2009	1		UNK	UNK	none	No	None		MN	1						1	Dizziness; Hot flush; Hyperhidrosis; Nausea; Vertigo	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA281AA~UNK~~~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0360694	10/13/2009	CA	5.0	5		F	10/13/2009	- fever started Friday. Reaching maximum 103.9 Saturday night. Gradually improved Sunday but low level fever (99F) still present Monday and Tuesday (10/12 and 10/13) - Started 150 mg Ibuprofen Saturday (10/10/2009) every 8 hours. Continued till Sunday night. - Called our physician who said that it was a reaction to flu nasal spray vaccine. She did not ask for tests or other visits.									U	10/06/2009	10/09/2009	3		PUB	UNK	- None - No previous adverse reactions to any other vaccinations	No	Allergy to nuts			1						1	Immunisation reaction; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360695	10/13/2009	WI	68.0	66		F	10/13/2009	ITCH, REDNESS AT SITE OF INJECTION, BODY ACHES.									Y	10/09/2007	10/10/2009	732	pATIEN TOOK BENADRYL AND TYLENOL AND FELT FINE NEXT DAY	UNK	PVT		NONE	NONE			1						1	Injection site erythema; Injection site pruritus; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98442P1B~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360696	10/13/2009	OR	3.0	3		F	10/13/2009	Stomach cramping from 4:35-5:45  Vomiting at 5:45									Y	10/13/2009	10/13/2009	0		UNK	UNK		none	none		OR	1						1	Abdominal pain upper; Vomiting	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500751P~UNK~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA		Influenza
0360697	10/13/2009	MI	38.0	38		F	10/13/2009	Rapid heart beat for 45 minutes, shortness of breathe, light-headed, nausea				Y					Y	10/07/2009	10/07/2009	0	Doctor performed EKG, blood pressure and exam.  Results were normal at time of exam.  Exam time was approximately 12:45pm.	UNK	PVT	2 Execedrin tablets taken at 7:30 am that morning.  Ocella (28) taken night before.	none	Allergic to Ampencilin, Sulfa, Codeine			1						1	Dizziness; Dyspnoea; Electrocardiogram normal; Heart rate increased; Nausea	FLUX~UNKNOWN MANUFACTURER~~1~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360698	10/13/2009	MA	52.0	52		M	10/13/2009	Tightness in my chest, shortness of breath, woke up through the night. Shortness of breath the next day.									Y	10/10/2009	10/11/2009	1		UNK	UNK		no	no			1						1	Chest discomfort; Dyspnoea; Poor quality sleep	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~972165P~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360701	10/13/2009					U	10/13/2009	This case was reported by a physician and described the occurrence of Bell's Palsy in a subject of unspecified age and gender who was vaccinated with Flu vaccine (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of Flu vaccine. At an unspecified time after vaccination with Flu vaccine, the subject experienced Bell's Palsy. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the Bell's Palsy was unspecified. The physician considered the event was not related to vaccination with Flu vaccine. The physician reported that a patient received a GSK flu vaccine and soon after was diagnosed with Bell's Palsy. The physician reported that he did not think there was any relationship with the flu vaccine and this diagnosis. The physician was anonymous. The subject denied permission to contact their physician.									U				UNK	OTH	OTH		Unknown			A0810930A	1						1	Facial palsy	FLU3~GLAXOSMITHKLINE BIOLOGICALS~~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0360706	10/13/2009	VA	76.0	76		F	10/13/2009	Pt. expired on 10/3/09. Attending MD did not believe immunization was cause of death but reported because of dose temporal proximity. (Pt. expired approx. 24 hrs after receiving the flu vaccine).   10/16/09 Death Certificate: Cardiorespiratory arrest, Diabetes mellitus type 2, Hypertension.	Y	10/03/2009							N	10/02/2009	10/03/2009	1		OTH	PVT	Metformin; Aricept; Coreg; HCTZ; Lexapro; Lisinopril; Synthroid; Namend; Insulin; Simvastatin	Diabetes; HTN; Dementia; hypothyroidism	NKDA			1						1	Death	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98431P1~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Results in Death	Influenza
0360708	10/13/2009	CA	65.0	65		F	10/13/2009	Patient woke up with a red, warm, tender left arm from her shoulder to elbow (10/12/2009).  The area was red & cellulitis - like.  She had an appointment with her family physician for other matters.									U	10/10/2009	10/12/2009	2		OTH	PVT	None known	None Known	None Known			1						1	Injection site cellulitis; Injection site erythema; Injection site pain; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98432P1~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1296X~1~IM~LA~PNEUMO (PNEUMOVAX)~1|VARZOS~MERCK & CO. INC.~1623X~1~SC~LA~ZOSTER LIVE (ZOSTAVAX)~1	USA		Influenza
0360709	10/13/2009	FL	58.0	58		F	10/13/2009	Rash on the chest, back and Rt wrist after 12 hours from receiving the flu vaccine. Patient came back to clinic 3 days later preventing herpetic rash. Tx ACYDOVIR 800 mg 5x/day x 7  days.										10/09/2009	10/10/2009	1	None	OTH	OTH		None	None			1						1	Herpes zoster; Rash	FLU3~SANOFI PASTEUR~u3204AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360710	10/13/2009	NV	50.0	50		F	10/13/2009	Nausea, chills, fatigue & syncopal episode requiring emergency care, sutures, X-rays, CT scan, secondary wound infection.				Y					N	10/03/2009	10/03/2009	0	X-rays & CT scan	OTH	PVT	None	None	None			1						1	Chills; Computerised tomogram; Fatigue; Nausea; Syncope; Wound infection; X-ray	FLU3~SANOFI PASTEUR~U3194AA~7+~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360711	10/13/2009	MT	14.0	14		F	10/08/2009	Upon injection pt momentarily fainted:  Eyes closed, body slumped.  Eye lids fluttered open & pt began to cry saying her ears hurt.  Laid pt. down - applied cool paper towels to forehead.  Pt rested & felt better after Approx 15 min.									Y	10/07/2009	10/07/2009	0		PUB	PUB	None	None	None			1						1	Ear pain; Eye movement disorder; Syncope	FLU3~CSL LIMITED~02149211A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB360BA~2~IM~LA~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~0570X~2~IM~LA~HPV (GARDASIL)~1|VARCEL~MERCK & CO. INC.~0850Y~2~SC~RA~VARICELLA (VARIVAX)~1	USA		Influenza
0360712	10/13/2009	ID	63.0	63		M	10/06/2009	Immediately after vaccination (30 min) headache and feverish feeling last couple days 1 day of significant emesis. Hourly!									Y	09/30/2009	09/30/2009	0	None	PVT	PVT	None	None	None			1						1	Headache; Immediate post-injection reaction; Pyrexia; Vomiting	FLU3~CSL LIMITED~06549111a~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360713	10/13/2009	GA	6.0			M	10/13/2009	Redness, swelling at the site of the FLUZONE shot.														PVT	PUB						1						1	Injection site erythema; Injection site swelling	FLU3~SANOFI PASTEUR~U3208AA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360714	10/13/2009	GA	17.0	17		F	10/17/2009	Pt had a mild seizure according to mother and passed out while still sitting in pharmacy.  Pt was pale.  Mom was able to take her to urgent care.				Y					U	10/13/2009	10/13/2009	0		OTH	PVT			Pt known to pass out after getting injections.			1						1	Convulsion; Loss of consciousness; Pallor	FLUN3~MEDIMMUNE VACCINES, INC.~50071AP~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0360716	10/13/2009	OH	12.0	12		M	10/13/2009	Sat after injections pt felt fine. Pt states that the only time his arm hurt when he opened his pop bottle. Sunday AM when woke up both arms were hurting, both arms were swollen at this time. Monday morning his rt. arm was swelling even more and the injection site was bigger. Left arm was starting to swell and under his arm was swollen. Then Monday morning pt woke up with fever, cough and a lot of pain.				Y					Y	10/10/2009	10/11/2009	1		PVT	PUB	ALBUTEROL (prn)					1						1	Cough; Injection site swelling; Oedema peripheral; Pain; Pain in extremity; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500725P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~MERCK & CO. INC.~0604Y~UNK~IM~RA~HEP A (VAQTA)~1|MNQ~SANOFI PASTEUR~U3029AA~UNK~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~UF486DA~UNK~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0360717	10/13/2009	NY	8.0	8		M	10/13/2009	Pt had flu vaccine 10/8 in AM.  Developed multiple hives all over trunk, arms 10/11 evening.  Treated with BENADRYL - seen in office 10/12/09 with continued hives.  Also was in haymaze over we, had temp 101 on 10/12/09.				Y					Y	10/08/2009	10/11/2009	3	None	PVT	PVT		None	Seasonal Allergies.			1						1	Body temperature increased; Urticaria	FLU3~SANOFI PASTEUR~U3186AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360718	10/13/2009	PA	5.0	5		M	10/13/2009	Patient had 1st flu vaccine on 9-26-09.  Patient received 2nd flu vaccine on 10-10-09.  Inadvertently (less than 4 weeks).										10/10/2009			None	PVT	PVT	PPD test; Manufacturer Sanofi Pasteur; Lot number C3150AA; Route/Site Intra Dermal; Date given 10-8-09.	None	Asthma, Seasonal Allergies.			1						1	Inappropriate schedule of drug administration	FLU3~SANOFI PASTEUR~U3186AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360720	10/13/2009	CA	11.0	11		M	10/12/2009	Shot admin 10-8. On 10-9 pt apparently had temp as high as 102 degrees and a decreased appetite, nausea. Mother reported on 10-12 pt is much improved.									Y	10/08/2009	10/09/2009	1	None	PUB	PUB	None	None reported	None			1						1	Body temperature increased; Decreased appetite; Nausea	FLUN3~MEDIMMUNE VACCINES, INC.~500697P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360721	10/13/2009	CA	55.0	55		F	10/13/2009	Right arm -> red, swollen, tender and warm to touch.									U	10/05/2009	10/05/2009	0		OTH	UNK			NKA			1						1	Erythema; Oedema peripheral; Skin warm; Tenderness	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA449AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1|PPV~MERCK & CO. INC.~0627Y~UNK~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360722	10/13/2009	NY	49.0	49		F	10/13/2009	9/23 10-15 min after rapid heart beat, sweat, nausea & tired all day. Same nausea x 5 days. Next day nausea joint ache 9/25 severe stuffiness headache facial pain paleness.									Y	09/23/2009	09/23/2009	0	None	PUB	PVT	Sinthroid .088 qOD Sinthroid .075 qOD	None	Hypothroid			1						1	Arthralgia; Facial pain; Fatigue; Headache; Heart rate increased; Hyperhidrosis; Nasal congestion; Nausea; Pallor	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA470AA~1~IJ~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0360724	10/13/2009	WI	19.0	19		F	10/13/2009	Patient still had bruise at injection site on day 18.									U	09/21/2009				UNK	PVT						1						1	Injection site haematoma	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360730	10/13/2009	MA	28.0	28		F	10/01/2009	Red, watery eyes, cough, hoarseness in throat, facial/neck redness and blotching, increased HR and SOB. Treated with 60 mg of PREDNISONE x 2 days, 40 mg x 2 days, 20 mg x 2 days.				Y					Y	09/29/2009	09/29/2009	0		PUB	OTH	KARIVA; ALPRAZOLAM	No	NYQUIL-rash; BENADRYL-hives. 5/12/2003 pre-hire exam. Anxiety, herpes zoster			1						1	Cough; Dysphonia; Dyspnoea; Erythema; Heart rate increased; Lacrimation increased; Ocular hyperaemia; Rash macular	FLU3~SANOFI PASTEUR~0201AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360731	10/13/2009	FL	4.0	4		F	10/09/2009	Chest pain left side oppressive ( persistent for 2 hours) within 4 hours of getting the flu shot. No associated signs or symptoms.									Y	10/07/2009	10/07/2009	0	EKG Normal	UNK	UNK		None	None			1						1	Chest pain; Electrocardiogram normal	FLU3~SANOFI PASTEUR~UT3178BA~3~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360732	10/13/2009	TX	8.0	8		F	10/12/2009	Pt received FLUMIST and VARIVAX, within few minutes had profuse vomiting and severe abdominal pain with perioral cyanosis. POX 97-100%.				Y					Y	10/02/2009	10/02/2009	0	None	PVT	PVT	None	None-doing well visit at time	None			1						1	Abdominal pain; Cyanosis; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~500677P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|VARCEL~MERCK & CO. INC.~0989Y~2~SC~RA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0360735	10/13/2009	NM	63.0	63		F	10/13/2009	Patient had tingling & a swollen feeling on her left side of her face.  She feels itchy & has mild nerve pain.  I believe it is her ZOSTAVAX vaccine given on 10/8/09.  She may have gotten a mild form of shingles.				Y					U	10/08/2009	10/13/2009	5		PVT	PVT	NEXIUM; HCTZ, LISINOPRIL; CENIFIDAROZIL; VIT D; CERT.	No	NKA			1						1	Feeling abnormal; Herpes zoster; Neuralgia; Paraesthesia; Pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA456BA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1|VARZOS~MERCK & CO. INC.~0747Y~1~SC~UN~ZOSTER LIVE (ZOSTAVAX)~1	USA	Emergency room visit	Influenza
0360736	10/13/2009	WI	53.0	53		F	10/09/2009	Chills, nasal congestion, aches within 1 of injection, followed by puffy eyes in 12 hours, tightness in chest, hoarseness.				Y					Y	10/07/2009	10/07/2009	0	None	PUB	PVT	Synthroid	No	Low thyroid. Similar reaction to flu shot in 1976	same~Influenza (Seasonal) (no brand name)~1~20.00~Patient		1						1	Chest discomfort; Chills; Dysphonia; Eye swelling; Nasal congestion; Pain	FLU3~SANOFI PASTEUR~U3205CA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360737	10/13/2009	PA	54.0	54		F	10/13/2009	Developed Hives, especially around the Neck, Scratchy throat as well as hoarseness. I gave myself BENEDRYL 25mg orally at time of Reaction: at 24 hours past Reaction still with Hoarseness, otherwise recovered.									Y	10/12/2009	10/12/2009	0		PVT	UNK		None	Allergy to Penicillin, Tetracycline, Percodan; Hx of HTN and high Cholesterol			1						1	Dysphonia; Throat irritation; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA460AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0361622	10/13/2009	MA	13.0	13		F	10/09/2009	+ hives and joint swelling after FLUMIST spray was given. Symptoms developed after 10 hours from the dose.				Y					U	10/01/2009	10/01/2009	0	CBC, CRP, ESR	PVT	PUB	AMOXICILLIN for Strep Pharyngitis	None	Obesity			1						1	C-reactive protein; Full blood count; Joint swelling; Red blood cell sedimentation rate; Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500705P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0359833	10/14/2009	DE	62.0	62		F	10/06/2009	Sore, hot, red at site and down the arm with itching. Continued into Saturday.									Y	10/02/2009	10/02/2009	0		OTH	UNK		None				1						2	Injection site discomfort; Injection site erythema; Injection site pruritus; Injection site swelling; Injection site warmth; Pain; Road traffic accident; Injection site erythema; Injection site pain; Injection site pruritus; Injection site warmth	FLUX~UNKNOWN MANUFACTURER~~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~1~IM~RA~PNEUMO (NO BRAND NAME)~1|FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~0632Y~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~2|PPV~MERCK & CO. INC.~98435P1~UNK~UN~LA~PNEUMO (PNEUMOVAX)~2	USA		Influenza
0360699	10/14/2009	SC	30.0	30		F	10/14/2009	It started with sore throat and post nasal drainage the first night (10/11).  The next day it progressed to sinus congestion, headache, cough, sneezing, sore throat. On 10/13 I had fever, chills, body aches, cough, sore throat, upset stomach. I started Tamiflu mid day on 10/13 after being tested.  I did not have to work on 10/13 anyway, and am unable to work on 10/14 due to this illness. As a physician, I exposed my patients unknowingly on 10/12, and it is a huge inconvenience (to my patients and to my office) to have to miss work due to illness.									U	10/09/2009	10/11/2009	2	Influenza A +, Flu B neg	UNK	UNK	Zyrtec, Advair, Apri OCPs, glucosamine chondroitin, multivitamin	no	asthma, allergic rhinitis			1						1	Abdominal discomfort; Activities of daily living impaired; Chills; Cough; Headache; Influenza; Influenza serology positive; Oropharyngeal pain; Pain; Postnasal drip; Pyrexia; Sinus congestion; Sneezing	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500757P~1~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA		Influenza
0360700	10/14/2009	GA	29.0	29		F	10/14/2009	Upon getting the vaccine in my left arm, I immediately had pain radiate into my upper arm and neck, it then proceeded down into my hand.  By 7:00AM, I had a whelp come up about 4 inches below the injection site and my left hand began to swell.  About 7:15AM, I started iching.  I immediately called the ER and was informed to take 50mg of Benadryl and if the symptoms were no better in 30 minutes to come back to the ER.  Well by 8:15AM, I had a lump in my throat and was having trouble clearing my throat, no trouble breathing at this point just my throat bothering me.  I came back to the ER at 9:30AM and I had redness in my face and a burning sensation to my face.  I was started with an IV.  I was given Benadryl, Salumedral, Atarax, and Zantac on a 30 minute drip.  I was to be dicharged at 12:30PM.  When I started to stand up, I was real dizzy and had to sit back down on the stretcher.  My nurse got me a wheel chair, took me to triage, checked my vital signs - they were ok and she discharged me.  I was wheeled to the cafeteria to get something to eat.  After finishing, I stood up to walk and almost fell again.  I had to be wheeled out of the cafeteria, it was 13:00PM by this point.  I went back to the department where I work and wa sitting with my coworkers until my husband came to pick me up, because I couldn't drive.  Around 14:00PM, I started feeling bad and got this weird taste in my mouth.  Immediately after this, I got cotton mouth and couldn't hardly talk due to my tongue sticking to the roof of my mouth.  This sensation went away, but came back several times on and off.  I went back to the ER around 14:30PM.  While in the room, I had this excruciating pain hit me in my left hip and radiate down to my toes and my left leg went completely numb.  After about 15 minutes I got the feeling back in my leg, but it still did not feel right.  I was admitted into the hospital for overnight observation.  Around 21:30PM on 10/09/2009, I had a spell of tachycardia -160BPM and was put on the talimytry monitor for my heart and was given a breathing treatment.  I had another round of salumedral, atarax, and zantac.  I slept all night.  On 10/10/2009, around 9:30AM, I had another spell of tachycardia -145BPM and chest pain.  I was administered an EKG, it showed no sign of an attack, but did show tachycardia of 123BPM.  I was kept in the hospital a second night for more observation.  My blood glucose was 293 and I was given insulin.  On 10/11/2009, I was discharged from the hospital to home.  On 10/12/2009, I started have a tingling sensation in my left leg again, like it was trying to go to sleep and problems with my heart racing, went back to the doctor, just as a precaution.  Today is 10/13/2009 and I have still got some redness and swelling in my face and still have some tingling in my left leg.  12/11/09 DC summary and H&P for DOS 10/09/09-10/11/09. DX: Tachycardia, not feeling well, hypersensitivity to flu vaccine.  Pt c/o hypersensitive reaction to the flu vaccine, swelling, numbness and feeling bad. L leg became numb. Tx: prednisone and Zantac for dyspepsia.  TSH was low with T3 and sinus tachycardia. Assessment: euthyroid 6 syndrome, glucose intolerance. BP was elevated. Pt improved and discharged home with Inderal and Metformin.				Y	Y	3			N	10/09/2009	10/09/2009	0	cbc and cest x-ray  DX studies: HR: 160 bpm, TSH: 0.24 (L), T3: 44.9, Glucose 289 mg/dl (H)	UNK	UNK		HAD FLU THREE WEEKS PRIOR.  STARTED TAMIFLU ON SEPTEMBER 26, 2009 AND FINISHED ON OCTOBER 1, 2009.  WAS GIVEN FLU SHOT ON OCTOBER 9, 2009.	Upon getting the FLU vaccine in my left arm, I immediately had pain radiate into my upper arm and neck, it then proceeded down into my hand.  By 7:00AM, I had a whelp come up about 4 inches below the injection site and my left hand began to swell.  About 7:15AM, I started iching.  I immediately called the ER and was informed to take 50mg of Benadryl and if the symptoms were no better in 30 minutes to come back to the ER.  Well by 8:15AM, I had a lump in my throat and was having trouble clearing my throat, no trouble breathing at this point just my throat bothering me.  I came back to the ER at 9:30AM and I had redness in my face and a burning sensation to my face.  I was started with an IV.  I was given Benadryl, Salumedral, Atarax, and Zantac on a 30 minute drip.  I was to be dicharged at 12:30PM.  When I started to stand up, I was real dizzy and had to sit back down on the stretcher.  My nurse got me a wheel chair, took me to triage, checked my vital signs - they were ok and she discharged me.  I was wheeled to the cafeteria to get something to eat.  After finishing, I stood up to walk and almost fell again.  I had to be wheeled out of the cafeteria, it was 13:00PM by this point.  I went back to the department where I work and was sitting with my coworkers until my husband came to pick me up, because I couldn't drive.  Around 14:00PM, I started feeling bad and got this weird taste in my mouth.  Immediately after this, I got cotton mouth and couldn't hardly talk due to my tongue sticking to the roof of my mouth.  This sensation went away, but came back several times on and off.  I went back to the ER around 14:30PM.  While in the room, I had this excruciating pain hit me in my left hip and radiate down to my toes and my left leg went completely numb.  After about 15 minutes I got the feeling back in my leg, but it still did not feel right.  I was admitted into the hospital for overnight observation.  Around 21:30PM on 10/09/2009, I had a spell of tachycardia -160BPM and was put on the talimytry monitor for my heart and was given a breathing treatment.  I had another round of salumedral, atarax, and zantac.  I slept all night.  On 10/10/2009, around 9:30AM, I had another spell of tachycardia -145BPM and chest pain.  I was administered an EKG, it showed no sign of an attack, but did show tachycardia of 123BPM.  I was kept in the hospital a second night for more observation.  My blood glucose was 293 and I was given insulin.  On 10/11/2009, I was discharged from the hospital to home.  On 10/12/2009, I started have a tingling sensation in my left leg again, like it was trying to go to sleep and problems with my heart racing, went back to the doctor, just as a precaution.  Today is 10/13/2009 and I have still got some redness and swelling in my face and still have some tingling in my left leg.  PMH: mastitis, hysterectomy.			1						1	Arthralgia; Blood glucose increased; Burning sensation; Chest X-ray; Chest pain; Dizziness postural; Dry mouth; Dysgeusia; Dysstasia; Electrocardiogram; Erythema; Feeling abnormal; Full blood count; Hypoaesthesia; Immediate post-injection reaction; Neck pain; Oedema peripheral; Pain in extremity; Palpitations; Paraesthesia; Pruritus; Sensation of foreign body; Speech disorder; Swelling face; Tachycardia; Throat irritation; Urticaria	FLUX~SANOFI PASTEUR~u3201aa~UNK~IM~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Hospitalisation	Influenza
0360738	10/14/2009	VA	7.0	7		F	10/14/2009	Patient had seizure and fell flat on her back, stiffly.  Arms and legs shook (not violently); eyes stayed open and did not roll back.  Patient reports seeing everything go blurry and does not remember what happened.  At the time, she was also experiencing either a bad cold or mild virus with slight fever.				Y					Y	09/01/2009	09/03/2009	2	Sleep deprived EEG done later in September and results were normal.	UNK	UNK		None known at time.	N/A			1						1	Amnesia; Convulsion; Electroencephalogram normal; Fall; Musculoskeletal stiffness; Tremor; Vision blurred	FLUX~UNKNOWN MANUFACTURER~~1~~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360740	10/14/2009	SC	11.0	11		F	10/14/2009	Patient c/o fever (100max), nasal congestion, cough, headache, sore throat, malaise starting on 10/10/09. Seen in clinic on 10/12/09 for continued symptoms. Throat culture neg for strep. Supportive measures prescribed. On 10/14/09, pharyngitis and cough had improved but continued with malaise. Tmax 101 on 10/13/09.				Y					U	10/08/2009	10/10/2009	2	Throat culture neg for group A streptococcus	PVT	PUB	Cholestyramine Prilosec Loestrin 24 Fe Viactiv chews Fluoxetine HCL Ranitidine	No	h/o ambiguous genitalia, cloacal anomalies, imperforate anus at birth, s/p multiple failed pull-through attempts, now with ileostomy. History of left adnexal mass and menometrorhagia, H/O VUR, left hydroureter, duplicated left collecting system, frequent UTIs. Last VCUG and IVP WNL. H/O GERD			1						1	Cough; Culture throat negative; Headache; Malaise; Nasal congestion; Oropharyngeal pain; Pharyngitis; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500717p~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0360741	10/14/2009	SC	70.0	70		F	10/14/2009	Mid afternoon this employee noted itching of both eyes with the Left eye being more affected, lids appeared to have red whelps on the upper Left lid.  The whelps resolved and then the upper eyelids were red and puffy when she went to bed on 9/29/09.  Upon awakening on 9/30/09 the swelling was still present, but more pronounced on the Left lid.									Y	09/29/2009	09/29/2009	0	None	PVT	PVT	Attenolol, Omeprazole	None	Seasonal Allergies			1						1	Eye pruritus; Eyelid oedema; Ocular hyperaemia; Urticaria	FLU3~CSL LIMITED~0684911A~7+~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360742	10/14/2009	CA	23.0	23		M	10/14/2009	Vigorous reaction due to inappropriate dosing (15 jabs for immunologically naive patient), resulting in satellite lesions forming.  Initiated antibiotic for bacterial prophylaxis and NSAID for analgesia.				Y						09/29/2009	10/13/2009	14	None.	MIL	MIL	None	No	None			1						1	Incorrect dose administered; Vaccination complication	FLUX~UNKNOWN MANUFACTURER~~5~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~2~~LA~PNEUMO (NO BRAND NAME)~1|TYP~UNKNOWN MANUFACTURER~~UNK~~LA~TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360743	10/14/2009	OH	25.0	25		F	10/13/2009	3:15pm - 4:00pm 1st time patient had a flu shot.  Within 15 minutes after giving flu vaccine, patient complained of feeling like something was in her throat, also very little bit of puffiness in cheeks. She could breathe ok. Administered 50mg Benadryl IM. Took Blood pressure (130/91). Patient felt light headed. Patient lied down. Called 911. EMT arrived approx 15 min later. B/P was 140/85. Decided to take to ER because complaining of light headed.				Y					Y	10/13/2009	10/13/2009	0		OTH	PVT			Seasonal Allergies			1						1	Dizziness; Sensation of foreign body; Swelling face	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~983431P1A~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360744	10/14/2009	PA	76.0	76		M	10/13/2009	Yes symptoms began around 11am on Oct 10, 2009 continued until Sunday Oct 11, 2009 about 12 pm. Dizziness, vertigo, imbalance. General weakness through body all over. Lethargic similar to Meniere's symptom. Blurred vision. Everything cleared by Monday. 10-12-09									Y	10/10/2009	10/11/2009	1	No	MIL	MIL	Lisinopril, Pantoprazole, Rosuvastatin, Flunisolide, Chlorpheniramine; Albuterol; Aspirin; Potassium; Ibuprofen; Levothyroxine; Atenolol. Lip-Flavonoid; Ginko-Bilov	No	Heart condition; Cholesterol; Reflux; Blood pressure			1						1	Asthenia; Balance disorder; Dizziness; Lethargy; Vertigo; Vision blurred	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98437P1A~1~IJ~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360745	10/14/2009	NY	46.0	46		F	10/14/2009	Migrane, Fatigue, Low grade temp, pain at injection site, Nausea									Y	10/08/2009	10/08/2009	0	none	PVT	PVT		none	none			1						1	Body temperature increased; Fatigue; Injection site pain; Migraine; Nausea	FLU3~SANOFI PASTEUR~~1~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360748	10/14/2009	TX	58.0	58		M	10/14/2009	noticed achiness to arm where vaccine was received; taking Ibuprofen 3 times a day with some relief									U	10/02/2009	10/03/2009	1	none	UNK	PVT	Atenolol and Nifedipine	none	hypertension			1						1	Injection site pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA460BA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0360749	10/14/2009	VT	2.0	2	.8	F	10/14/2009	Woke up itching on legs, hives developed.  Patients father denied any difficult with breathing, patient acting well otherwise.  Hives improved with Benedryl.									Y	10/10/2009	10/11/2009	1	None	PVT	PVT		No	Premature at 27 weeks gestation			1						1	Injection site pruritus; Injection site urticaria	FLU3~SANOFI PASTEUR~U3177AA~2~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360750	10/14/2009	CA	73.0	73		M	10/14/2009	Seizure led to patient going to ICU. Still in the hospital and suffering from short term Amnesia.  11/2/09:  Infectious Disease Consultation received for date of service 10/10/09: Dx:  Convulsions consistent with seizure.   Assessment:  Started on Effexor and got a flu shot and began to experience abdominal distension and bloating thereafter, also experienced general aches, nausea and vomiting. The patient was noted to be more fatigued, and a convulsion was witnessed on the day of admission.  The pt. was febrile in the ICU prompting the ID evaluation.   Hyponatremia was noted.  The hyponatremia or intolerance of the Effexor were thought to be the cause of the seizure.    11/2/09:  ICD 9 Codes Received:  780.97, 253.6, 348.31, 304.01, 338.29, 719.45, 276.8, 244.9, 530.81, 401.9, 272.4, 780.39, 383.9, 275.41, 265.2, 300.4, 785.0, 794.8, V43.65.					Y	6			U	10/08/2009	10/10/2009	2	11/2/09:  Infectious Disease Consultation received for date of service 10/10/09:  Labs and Diagnostics: EEG-Abnormal.  PH 7.48 (H), PCO2 34.8 (L), HCO3 26.2 (H).  Sodium 134 (L), Glucose 131 (H).  Tot. Protein 6.0 (L), ALB> 3.2 (L), Calcium 8.7 (L), AST 144 (H), ALT 195 (H).CBC:  RBC 3.82 (L), Hgb 11.9 (L), Hct 34.4 (L), MCH 31.3 (H), MPV 5.8 (L), Mono % 11.5 (H), Eos. % 8.6 (H).  Blood Cultures-no growth.  Urine culture-no growth.  CT Angio Chest-Abnormal.  Head CT-Abnormal. CXR-No acute findings.  US Abdomen-WNL.	UNK	UNK		none	none. 11/2/09:  Infectious Disease Consultation received for date of service 10/10/09:  PMH:  Hypertension, Hyperlipidemia, Osteoarthritis, s/p bilateral knee replacement, Hypothyroidism, Vicodin dependence due to chronic pain, Intolerance to Paxil.			1						1	Amnesia; Convulsion; Intensive care	FLU3~SANOFI PASTEUR~43194aa~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0360751	10/14/2009	MI	1.04	1	.0	M	10/08/2009	Patient was seen on 10/1/09. Death reported on 10/4/09. Pt has seizure disorder along with encephalocele. / DANDY WALKER Syndrome. Had received vaccines on 10/1/09.	Y	10/04/2009							N	10/01/2009	10/04/2009	3		PVT	UNK		none	Seizure disorder; DANDY WALKER syndrome			1						1	Death	FLU3~SANOFI PASTEUR~UT3178DA~1~UN~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB334BA~1~UN~LL~HEP A (HAVRIX)~1|HIBV~SANOFI PASTEUR~UF673AA~4~UN~RL~HIB (ACTHIB)~1|MMR~MERCK & CO. INC.~0554Y~1~UN~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~0731Y~1~UN~RA~VARICELLA (VARIVAX)~1	USA	Results in Death	Influenza
0360752	10/14/2009	MA	48.0	48		F	10/06/2009	Guillain-Barre Syndrome - 1st seen here 2/4/09 - Hospitalization and long rehab stay - Still symptomatic 10/5/09.  12/03/09 and 12/08/09 MR and DC summary received for DOS 02/13/09  02/20/09 Final DX: Guillain Barre syndrome, hyponatremia  Pt presented with abdominal and back pain, parasthesias, bilateral weakness, diplopia, hyponatremia, unstable gait, and frontal headache. On neurological examination: ophthalmoparesis, absent reflexes, UE ataxia, sensory loss. Pt diagnosed with GBS. Tx: normal saline, IVIG. Pt with SIADH.   Pt's sensation and strength improved. Pt discharged home.  12/07/09 MR received for DOS 02/21/09  02/25/09. DX: Acute inflammatory demyelinating polyneuropathy, s/p IVIG. Pt in rehab hospital. Neurological exam: cranial nerve deficits on L side; muscle strength 3/5 proximally in BLE and 4/5 distall; DTRs absent; dysesthetic in trunk and extremities. Pt has atypical GBS. Pt discharged home.					Y	7			U	12/02/2008	01/31/2009	60	Would need medical record  12/03/09 and 12/08/09 MR and DC summary received for DOS 02/13/09  02/20/09 Lab and DX studies: BP 160-170/80, HR 50, Na 115; CSF: 22 WBC, 0 RBC, glucose 58, protein 299; EMG/nerve conduction studies: demyelination; MRI: multilevel degenerative disase	PVT	UNK		No	Hypertension; Multicystic Kidney disease  12/03/09 and 12/08/09 MR and DC summary received for DOS 02/13/09  02/20/09 PMH: arthritis, gastritis, GERD, polycystic kidney disease, mild pancreatitis. Allergies: NKDA			1						1	Guillain-Barre syndrome	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA388BA~4~IM~UN~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Hospitalisation	Influenza
0360756	10/14/2009	IN	35.0	35		F	10/06/2009	Edema & inj site - Vesicle rash lower breast right & right axilla.  Rec. some MEDROL 80 mg IM in ED; Rx for MEDROL dose pack & AUGMENTIN X 5 days.				Y					Y	10/01/2009	10/02/2009	1		PVT	PVT	Vitamins.	None known	None Known	redness years ago to fluzone flu vaccine denies egg allergy~Influenza (Seasonal) (Fluzone)~UN~0.00~Patient		1						1	Injection site oedema; Injection site rash; Rash vesicular	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA466AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0360758	10/14/2009	IN	34.0	34		F	10/05/2009	Injection site red-itching immediately after injection-to ED and received BENADRYL 50 mg IM.				Y					Y	09/16/2009	09/16/2009	0		PVT	PVT	Unknown	None known	None known			1						1	Immediate post-injection reaction; Injection site erythema; Injection site pruritus	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA466AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0360759	10/14/2009	MO	34.0	34		F	10/04/2009	Pt. felt nauseous immediately and rested head against wall was semi unconscious. Pt. was laid on ground w/ feet up. EMS was called.				Y					Y	10/04/2009	10/04/2009	0		OTH	PVT	FEXOFENADINE 180mg; PROAIR inhaler	Recent case of bronchitis (fully recovered)	Asthma			1						1	Depressed level of consciousness; Immediate post-injection reaction; Nausea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98445P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360760	10/14/2009	HI	38.0	38		M	10/08/2009	Fever, Diarrhea.									Y	09/21/2009	09/22/2009	1	None	UNK	UNK		None	None			1						1	Diarrhoea; Pyrexia	FLU3~CSL LIMITED~03649111A~UNK~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360761	10/14/2009	AZ	4.0	4		F		Developed swelling, redness day following administration (10/1/09). Presented to ED on 10/3/09 (Saturday) - Dx with cellulitis and Rx with KEFLEX - mother reports that improved within 24-48 hours.				Y					Y	10/01/2009	10/02/2009	1	None	PVT	PVT		None	None			1						1	Cellulitis; Erythema; Swelling	DTAPIPV~GLAXOSMITHKLINE BIOLOGICALS~AC20B116BA~UNK~IM~LL~DTAP + IPV (KINRIX)~1|FLU3~SANOFI PASTEUR~U32014A~3~IM~RL~INFLUENZA (SEASONAL) (FLUZONE)~1|MMR~MERCK & CO. INC.~07064~2~SC~LL~MEASLES + MUMPS + RUBELLA (MMR II)~1|VARCEL~MERCK & CO. INC.~10494~2~SC~RL~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0360762	10/14/2009	WA	57.0	57		F	10/06/2009	Pt. states she wound up in ER as flu vaccination entered artery instead of muscle.				Y					Y	09/11/2009	09/12/2009	1		OTH	PVT	Acetaminophen/Codeine 30/325	None	None			1						1	Wrong technique in drug usage process	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360763	10/14/2009	MN	21.0	21		M	10/02/2009	Stuffy nose, sinus ache, body aches, cold sweats Sep 29th through Oct 2.									Y	09/28/2009	09/29/2009	1		PUB	UNK						1						1	Cold sweat; Nasal congestion; Pain; Sinus headache	FLUN3~MEDIMMUNE VACCINES, INC.~500715P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360764	10/14/2009	NC	25.0	25		F	10/08/2009	Approximately 10:10am RN called to assist client who was witnessed by co-worker to sit on couch in hallway then head fell back - upon RN arrival patient's eyes rolled back and not responsive to voice, shallow breathing. Thready pulse, lifted to floor to open airway, then responsive.				Y					Y	10/08/2009	10/08/2009	0	Upon EMT arrival pulse 98, Systolic BP 98 (1020am) color improved at 1025am client stood with drop in BP and recurrence of symptoms, that is loss of color rolled eyes back of head; transported to hospital.	OTH	PVT	Unknown	None reported	Reported history of fainting spells			1						1	Blood pressure decreased; Gaze palsy; Hypoventilation; Pallor; Posture abnormal; Pulse abnormal; Unresponsive to stimuli	FLU3~CSL LIMITED~07849111A~1~UN~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA	Emergency room visit	Influenza
0360766	10/14/2009	WA	0.51	0	.5	F	10/07/2009	She got rash on stomach, back, neck.									U	10/05/2009	10/05/2009	0		UNK	PUB		None		Rash~Influenza (Seasonal) (no brand name)~1~0.50~Patient		1						1	Rash	FLU3~SANOFI PASTEUR~U3174CA~2~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360768	10/14/2009	SC	75.0	75		F		Welts on both sides of neck, Rt arm and Rt leg. Informed by MD to take BENADRYL and bathe in Epsom Salt.									Y	09/22/2009	09/24/2009	2		OTH	PUB						1						1	Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~2~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360770	10/14/2009	NC	56.0	56		F	10/07/2009	Two days after receiving injection I developed a severe ulceration in the roof of my mouth. I didnt associate the two until I sent an email to all the other 45 employees who had also received it and 7 others had experienced either fever blisters or mouth ulcers 2-3 days after injection. It has been 4 days and ulcer is no bette.				Y					N	10/02/2009	10/04/2009	2	None	OTH	PVT	No New meds	None	None			1						1	Mouth ulceration	FLU3~SANOFI PASTEUR~U3194AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360771	10/14/2009	NC	70.0	70		F	10/07/2009	C/o feeling achy, chest and neck aching, dry hacking cough, weak and sick feeling. No fever - Sx began 4 hours after Flu vaccine injection and lasted 48 hrs.									Y	10/02/2009	10/02/2009	0		PVT	PVT		None	IBS; hypercholesterolemia; osteoporosis; allergic rhinitis			1						1	Asthenia; Chest pain; Cough; Malaise; Neck pain; Pain	FLU3~SANOFI PASTEUR~U3195AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360773	10/14/2009	MI	12.0	12		F	10/08/2009	Pt developed gen rash approx 15 min following imm. 50 mg BENAFRYL PO given. Denied itching, diff breathing, throat swelling. Mother states same gen rash reaction following 1st GARDASIL imm. resolved with time and BENADRYL per mother.									Y	10/07/2009	10/07/2009	0		PVT	PUB		none	Asthma; ADHD			1						1	Rash generalised	FLU3~SANOFI PASTEUR~U3196AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0229X~2~IM~RA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U3030AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1	USA		Influenza
0360774	10/14/2009	OH	63.0			M	10/06/2009	Treated in ED- Allergic reaction to flu shot-gave patient 40mg IM x 1 today. PREDNISONE taper, BENADRYL prn itching. Skin- rt hand and jaw erthemic and slightly edematous, multiple small erthemic patches on rt arm. Erythemic swollen area where flu vaccine was given on rt deltoid area. Symptoms 1. Skin Rash, 2. Rash 3. Erythema Multiforme, 4. small erythemic patches on trunk, red and swollen jaw and rt hand.										09/30/2009	09/30/2009	0		UNK	UNK			Patient received nicotine patches 2 days prior influenza administrating dose was decreased from 14mg to 7mg			1						1	Erythema; Erythema multiforme; Hypersensitivity; Injection site erythema; Injection site swelling; Joint swelling; Oedema; Oedema peripheral; Pruritus; Rash	FLU3~CSL LIMITED~08919111~2~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360775	10/14/2009	WY	15.0	15		U		Pt felt lightheaded, dizzy and stated everything went black.									Y	09/25/2009	09/25/2009	0		PVT	PUB	None	None	None			1						1	Dizziness; Visual impairment	FLUN3~MEDIMMUNE VACCINES, INC.~500695P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~1311X~UNK~IM~LA~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U3012AA~UNK~IM~RA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~UFU51AA~UNK~IM~RA~TDAP (ADACEL)~1	USA		Influenza
0360777	10/14/2009	IL	22.0	22		F	10/07/2009	Pt. reports development of hives same day as vaccine administration - Pt. did not contact our office until 10/6/09.				Y					U	09/23/2009	09/23/2009	0		PVT	PVT	SEROQUEL	None	None			1						1	Urticaria	FLU3~SANOFI PASTEUR~63198AA~1~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360778	10/14/2009	IL	65.0	65		F	10/01/2009	Within an hour of injection, patient began to experience soreness and swelling near injection site. She said it felt tight. She said it had not gone to her hand. RPh instructed her to use ice and take ibuprofen and take BENADRYL if worsened and call MD if worse right arm. Tried to call had to leave message-patient never called back.									U	10/01/2009	10/01/2009	0		OTH	OTH		none				1						1	Injection site pain; Injection site reaction; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0632Y~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360779	10/14/2009	MN	2.0	2	.0	F	10/09/2009	Shot given 9-29-09 at 17:00.  Mom called morning of 9-30-09 to report child had fever of 102 & would not walk.  She did not notice legs to be swollen.  She gave TYLENOL alt with Ibuprofen through the day.  Then 10-1-09 she was seen in clinic for fever 102 & not walk.  PPV leg site swollen.  She got fluids & MORPHINE for pain & ROCEPHIN.  She went home & temp was 104 at 17:00.  At 03:00 10.2 She woke up & wanted to eat.  She did not have a fever & started to walk.									Y	09/29/2009	09/30/2009	1		PVT	UNK			H B S beta positive Thalassemia.			1						1	Abasia; Body temperature increased; Injection site swelling; Pyrexia	FLU3~SANOFI PASTEUR~UT3273HA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~0504Y~1~IM~RL~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360780	10/14/2009	SC	45.0	45		F	10/14/2009	I received the flu shot on 10/02/09. I woke up the next day with a painful and swollen lymph node on the right side of my neck.									Y	10/02/2009	10/03/2009	1	None	PVT	PVT	Estrace 1mg PO daily, Synthroid 1mg, PO daily	None	History of malignant melanoma > 10 years ago.			1						1	Lymph node pain; Lymphadenopathy	FLU3~CSL LIMITED~06849111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360781	10/14/2009	WI	36.0	36		F	10/08/2009	I was pregnant when I received the flu vaccine. Sixteen days after getting the vaccine my son was stillborn at 36 weeks gestation. There was no reason found to explain his death.									U	10/30/2008	11/15/2008	16	Infant had genetic  testing which was negative.	PVT	PVT	multivatiman; sertraline; folic acid; polyethyeline glycol	None	Bacitracin allergy			1						1	Drug exposure during pregnancy; Stillbirth	FLU3~SANOFI PASTEUR~U2752AA~5~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360782	10/14/2009	FL	54.0	54		F	10/14/2009	HIVES AND SEVERE ITCHING.  SELF MEDICATIONS BENADRYL.  DOCTOR PRESCRIBED MEDICATION.				Y						10/09/2009	10/09/2009	0	NONE	UNK	UNK		NONE	ON MEDICATION FOR HIGH BLOOD PRESSURE			1						1	Pruritus; Urticaria	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360784	10/14/2009	MA	55.0	55		F	10/14/2009	Employee noticed a tender swelling at the lateral left shoulder/lateral acromion 6 cm above the injection site in addition to a small raised erythematous lesion at the site of injection.									Y	10/06/2009	10/06/2009	0	None; afebrile at time of evaluation on 10/7/09; symptoms resolving at follow-up evaluation on 10/14/09	PVT	PVT	Lisinopril 20 mg Toprol 25 mg Nexium 25 mg bid Zocor	None	Sensitivity to anti-inflammatories (NSAIDs); radiograph dye with hive response to each.  Recently diagnoses with lactose intolerance.			1						1	Injection site erythema; Injection site pain; Injection site swelling; Oedema peripheral; Skin lesion	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA447AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0360785	10/14/2009	AL	25.0	25		F	10/14/2009	Raised rash that was warm to touch and painful that started about an hour after being vaccinated. Pt. used ice and benadryl and that helped.				Y					U	10/12/2009	10/12/2009	0	No tests performed.	PUB	PVT		NONE				1						1	Pain; Rash; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98434P1~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360786	10/14/2009	NC	47.0	47		M	10/14/2009	Throat and tongue swelling. I was treated in the ER for allergic reaction.  Received IV benadryl, solumedrol and Tagamet.  Released after 2 and one half hours. 10/14/09 ED records received service date 10/12/09. Assessment: Allergic reaction to FluMist. Patient complained of throat swelling. Later said he felt better and was discharged.  10/20/2009 PCP records for wellness visit 10/20/2009   L			Y	Y					Y	10/12/2009	10/12/2009	0	10/14/09 ED records received service date 10/12/09. LABS and DIAGNOSTICS: Puls Ox 100% Room Air. Labs: CBC, CMP, Lipid profile and UA for wellness visit 10/20/2009	UNK	UNK		no.	none. 10/14/09 ED records received service date 10/12/09. Occasional alcohol use.			1						1	Hypersensitivity; Pharyngeal oedema; Swollen tongue	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500754P~1~IM~~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA	Life Threatening	Influenza
0360788	10/14/2009	TX	52.0	52		F	10/09/2009	On 10/6/09, this employee received her Seasonal Flu shot (FLUVIRIN, Novartis, lot# 98439P1, exp date 6/30/2010) she reported to the me on 10/7/09 that an hour after receiving the vaccine, her face broke out in an rash - no other symptoms - she took Benadryl at night only and HC cream on face. Reported to acting med doctor. Rec Benadryl after or see prescription steroid shot- reported to risk management.									Y	10/06/2009	10/06/2009	0	PM	OTH	OTH	Lisinopril, Levothyroxine; Lyrica; Tramoda	Arthritis and Fibromyalgia	Hypertension; Thyroid; Arthritis; Fibromyalgia; NKA; No birth defects.			1						1	Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98439P1~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360789	10/14/2009	IL	70.0	70		F	10/10/2009	Flu shot (seasonal) about 3 PM (9-15-09) awoke 645 AM (9-16-09) with discomfort - after getting up I had severe fast heart beat and weak left arm from 6:45 Am till 9:15 AM. I called DR. office about 9:30 AM and they called me back about 12:30 pm. I called then twice in the morning. The med. assistant said Dr recommended BENADRYL and I guess I should have gone to ER									U	09/15/2009	09/16/2009	1	None	PVT	PVT	TERAZOSIN; Lithium carb	None	Hypertension; Diabetes; Bipolar in remission			1						1	Discomfort; Heart rate increased; Muscular weakness	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360790	10/14/2009	CA	97.0	97		U		Immediately after flu shot given. - Became tired and confused. Daughter took me home. (She is an R.N). Took my B.P. 100/40 - P. 40. Remained at that level for about an hour. Then, gradually returned to normal 140/56 - P, 58.									Y	09/27/2009	09/27/2009	0		PUB	OTH			Sulfa; Aortic regurgitation			1						1	Confusional state; Fatigue; Heart rate decreased; Hypotension; Immediate post-injection reaction	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~66521~1~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360792	10/14/2009	ME	8.0	8		F	09/25/2009	Large red swollen area upper arm were flu shot was given approximately 6x6, warm to touch and hard no fever. Give Tylenol or Motrin for discomfort, cool compresses if doesn't improve in 24-48 hours call office back.										09/24/2009	09/25/2009	1		OTH	PUB						1						1	Discomfort; Injection site erythema; Injection site induration; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3178BA~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360794	10/14/2009	NM	60.0	60		F	10/01/2009	Large welts on body approx. 1 day after Flu and Pneumonia vaccines. Rash spread throughout body (facial, skin erythema).									Y	09/05/2009	09/06/2009	1		OTH	PVT						1						1	Erythema; Rash; Urticaria	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~978401P1~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1124X~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360795	10/14/2009	TX	29.0	29		M	09/19/2009	Pt. fainted about 5 minutes after administering FLUVIRIN vaccine.									Y	09/19/2009	09/19/2009	0		OTH	PVT						1						1	Syncope	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360796	10/14/2009	OH	37.0	37		F	10/06/2009	Swelling and pain around site.									U	10/03/2009	10/04/2009	1		UNK	UNK						1						1	Injection site pain; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1320Y~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360799	10/14/2009	MO	49.0	49		F	10/08/2009	Swollen eyes/lips cough > resolved on it's own.									Y	10/01/2009	10/01/2009	0	None	PUB	PVT						1						1	Cough; Eye swelling; Lip swelling	FLU3~SANOFI PASTEUR~U3173DA~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360800	10/14/2009	OH	48.0	48		M	10/06/2009	Felt Aches/weak									Y	10/03/2009	10/03/2009	0		UNK	UNK						1						1	Asthenia; Pain	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~1320Y~1~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360802	10/14/2009	IL	40.0	40		M	10/07/2009	Paralysis in both arms, lasted several per neurologist, pt had developed days an odd strain of Guillain Barre. 10/19/2009 records from neuro consult dated 9/23/2009. Patient presents 2 weeks post vaccine with sx of numbness, weakness , pain and poor grip strength in hands. PE notes minimally + Tinel's sign rt and lt wrists, diminished sensation of distal 3 first fingers. Tx: none at this time, Impression: post vaccine reaction, polymyalgias with borderline diabetic neuropathy.  10/26/2009 ED records for date 9/19/2009. Patient presented with c/o's weakness upper extremities, myalgias. PE did note LUE weakness. Tx none noted Dc DX Diffuse extremity weakness				Y					Y	09/05/2009	09/23/2009	18	Unknown Lab: Glucose 218 high, CBC, CPK and TSH WNL Dx studies: NCV study abnormal, noting borderline slow Rt medial sensory response. Labs: CMP: Glucose 281 High, ESR normal, RA factor negative Dx studies: EKG WNL	OTH	PVT	NASONEX	None	None  PMH: pt states borderline diabetic, no meds, treated with diet Family hx father is diabetic Allergies: NKDA			1						1	Monoplegia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360804	10/14/2009	AZ	77.0	77		F	10/09/2009	Initial report received on 29 September 2009 from an investigator in a trial. A 77 year old female subject developed chest pain on 25 September 2009, 16 hours after she had received an intramuscular injection of INFLUENZA VIRUS VAC USP TRIVAL A AND B HIGH DOSE, SUBVIRION-U (batch nubmer-UD12307), on left deltoid on 25 September 2009. The subject had a medical history of asthma, hypertension, anxiety and depression (details not provided). Family history included: The subject's father had a history of CVA (cerebrovascular accident) and mother had a history of questionable CVA or MI (myocardial infarction) in her older age to which she died. On 25 September 2009, the subject developed chest pain, shortness of breath and elevated blood pressure for which she went to the emergency room. MI (myocardial infarction) was ruled out and the final diagnosis of chest pain and hypertension was made leading to hospitalization on the same day. Concomitant medications were not reported. Laboratory tests included EKG and cardiac enzymes tests which ruled out MI (details not provided). Treatment details not provided. The event of chest pain resolved on 26 September 2009 and the subject was discharged from the hospital on the same day. The subject is planned to contact PCP (primary care physician) for cardiac stress testing. According to the investigator, the event of chest pain was not related to the study vaccine. The serious adverse event did not lead to the termination of the subject from the study. No documents were held by the sender. Follow up received on 03 October 2009: The subject was vaccinated about noon, was home at approximately 4 p.m. where she developed midsternal heaviness and tightness which lasted for hours and was associated with nausea and diaphoresis. She checked her blood pressure at home and the systolic pressure was found to be over 200 after which she called up 911 as the chest discomfort did not resolve. She was taken to the and given aspirin en route. At ER where she was treated with unspecified IV fluids and Oxygen, her blood pressure was 150/80 mmHg, heart rate of 88/ min, and oxygen saturation 99% on room air. She was hospitalized overnight, EKG and cardiac enzymes were tested which ruled out MI (Myocardial Infarction). The subject reported that she believes that the events may be related to the vaccine she received but is unsure. The chest pain gradually resolved and the subject was discharged on 26 September 2009 the following day. The subject was allergic to Penicillin and Benadryl and she had also received unknown influenza vaccine in October 2008 and pneumococcal vaccine in 2008 (details not provided). Relevant concomitant medications included Benezapril 10 mg once daily and Alprazolam 0.5 mg once daily. Laboratory data included a blood test done on 25 September 2009 for NT-proBNP showed higher value of 823.5 mg/dl. CT scan of chest was done on 25 September 2009 did not show any pulmonary embolism. However, there was a presence of mild increased scattered atelectasis and/or infiltrate involving right lung base. EKG also showed mild mitral regurgitation, trace tricuspid regurgitation, aortic sclerosis and mild aortic regurgitation and no evidence of MI. According to the investigator, the event of chest pain was related to the study vaccine.					Y	2			Y	09/25/2009	09/25/2009	0	EKG and cardiac enzymes tests were done on 25 September 2009 which ruled out MI (myocardial infarction). EKG also showed mild mitral regurgitation, trace tricuspid regurgitation, aortic sclerosis and mild aortic regurgitation. Blood pressure was found 150/80 mmHg with a heart rate of 82/ min on arrival in ER on 25 September 2009. Blood test done on 25 September 2009 for NT-proBNP showed higher value of 823.5 pg/dl. CT chest done on 25 September 2009 did not show any pulmonary embolism. However, there is a presence of mild increased scattered atelectasis and/or infiltrate involving right lung base.	UNK	UNK	Alprazolam; Benazepril		The subject reportedly had medical history of asthma since 1939, hypertension since 2007, anxiety and depression since 2008. Relevant concomitant medications included Benezapril 10mg once daily and Alprazolam 0.5 mg once daily. The subject was allergic to Penicillin and Benadryl and she had also received unknown influenza vaccine in October 2008 and pneumococcal vaccine in 2008 (details not provided). Family history included : Father had a history of cerebrovascular accident (CVA) and mother had a questionable CVA or myocardial infarction (MI) in her older age due to which she died.	Allergy~Vaccine not specified (no brand name)~UN~0.00~Patient	200904111	1						1	Aortic arteriosclerosis; Aortic valve incompetence; Atelectasis; Blood pressure increased; Blood test abnormal; Cardiac enzymes; Chest discomfort; Chest pain; Computerised tomogram abnormal; Condition aggravated; Dyspnoea; Electrocardiogram abnormal; Hyperhidrosis; Hypertension; Mitral valve incompetence; Nausea; Tricuspid valve incompetence	FLU3~SANOFI PASTEUR~UD12307~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Hospitalisation	Influenza
0360807	10/14/2009	CA	70.0	70		F	10/09/2009	Eve of vaccine administered felt shaky- next day felt dizzy and sick at stomach- did not go to urgent care but was home for 2 days on third started feeling better.									Y	09/29/2009	09/29/2009	0		OTH	OTH		none	None			1						1	Abdominal discomfort; Dizziness; Tremor	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360810	10/14/2009	PA	51.0	51		M	10/09/2009	Had flu and PNEUMOVAX on 10/5/09. Started with fever, chills, temp >102 on 10/7, 10/8. Treated with TYLENOL - Pneumo site, red and warm on Tuesday, with pain. Wednesday less painful and no further spread of redness or warmth.										10/05/2009	10/06/2009	1		OTH	PVT		None	None			1						1	Body temperature increased; Chills; Injection site erythema; Injection site pain; Injection site warmth; Pyrexia	FLU3~CSL LIMITED~08449111A~1~UN~LA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~1134Y~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360811	10/14/2009	TX	47.0	47		F	10/05/2009	Pt with h/o Asthima here with c/o itching and rash to body. Pt accompanied by mother is also having the same problem. Pt states that she got flu shot on Thursday (10/01/09) and since yesterday noticed having some rash to the neck area associated with feeling of warmth in the same area. Pt states that she started having itching involving the chest/neck and arms this morning which is worsening now. Pt denies any shortness of breath or dizziness. Pt denies any change in diet or any other routine. Denies any change in cosmetics/detergent or diet. The history is provided by the patient. This is a new problem. The current episode started yesterday. The problem has been occurring constantly. The problem has been gradually worsening since onset. There has been no chest pain, no abdominal pain, no headaches, and no shortness of breath. The symptoms are worsened by nothing. The symptoms are relieved by nothing. She has tried nothing for the symptoms.				Y					Y	10/02/2009	10/03/2009	1	See attached documentation	PVT	PVT		None	Asthma			1						1	Pruritus; Rash; Skin warm	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98442P1B~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360812	10/14/2009	ND	38.0	38		F	10/06/2009	Developed thickened tongue and choking feeling about 1 hour after receiving vaccine. Developed itchy feeling - Took BENADRYL. Swollen lips by morning took CLARITIN.				Y					Y	09/30/2009	09/30/2009	0	None reported by client	PUB	PUB		None	Allergy to strawberries; Hypoglycemia			1						1	Choking sensation; Lip swelling; Pruritus; Tongue disorder	FLU3~SANOFI PASTEUR~U3201AA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360813	10/14/2009	ND	59.0	59		M	10/08/2009	Partial loss of use left arm at shoulder. Extreme pain rotator cuff. Unable to lift arm above shoulder level. Second flu shot pain up spinal cord and reoccurring pain at shoulder, after partial recovery-new onset.								Y	N	01/01/2009	06/10/2009	160	MRI; neurological consult	MIL	MIL		None	Degenerative disc disease; SCI			1						1	Back pain; Injected limb mobility decreased; Monoplegia; Musculoskeletal pain; Nuclear magnetic resonance imaging; Pain; Rotator cuff syndrome	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97847P2~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Disabling	Influenza
0360815	10/14/2009	OH	26.0	26		F	09/28/2009	9/14/09 - sore arm, achy feeling. 9/15/09 -  nausea, sore arm, achy feeling; 100 temp. 9/16/09 - nausea, sore arm, achy, cough, chest congestion, went home sick. - P.A.C. dx adverse reaction & adeno virus systems persisted through 9/20/09 - chest congestion & cough remains.				Y						09/14/2009	09/14/2009	0		OTH	UNK	TOPAMAX, LEVORA, FLONASE, AMBIEN, NAPROSYN	None	Fibromyalgia; allergy to quinilones			1						1	Adenovirus infection; Adverse reaction; Body temperature increased; Cough; Nausea; Pain; Pain in extremity; Respiratory tract congestion	FLU3~SANOFI PASTEUR~U3196AA~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360817	10/14/2009	OR	76.0	76		F	10/08/2009	Red, swollen, tender to touch Rt upper arm where vaccines were administered.									U	10/07/2009	10/08/2009	1		PVT	OTH	ATACAND 4mg; WARFARIN; ALBUTEROL; NEXIUM; CRESTOR; BYSTOLIC; TEMAZEPAM	None	Hypertension; Atrial fibrillation; Anemia; Hypercholesterolemia			1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~CSL LIMITED~05749111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~1435X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360818	10/14/2009	TX	2.0	2	.3	M	10/07/2009	Runny nose/ nasal congestion 10/4/09 - 10/7/09.  Fever (to 103.7).  Stomachache. Cough. 10/9/09 No residual sequelae.				Y						10/01/2009	10/04/2009	3	Rapid flu test -> positive influenza B.	PVT	PVT						1						1	Abdominal pain upper; Cough; Influenza serology positive; Nasal congestion; Pyrexia; Rhinorrhoea	DTAPIPVHIB~SANOFI PASTEUR~C3471AA`~1~UN~RL~DTAP + IPV + HIB (PENTACEL)~1|FLUN3~MEDIMMUNE VACCINES, INC.~500677P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0360819	10/14/2009	WV	7.0	7		M	10/08/2009	Red, swollen, hot to the touch on underside of left arm.				Y					Y	10/06/2009	10/07/2009	1	None	PVT	PVT		None	Asthma mild intermittent.			1						1	Injection site erythema; Injection site swelling; Injection site warmth	FLU3~SANOFI PASTEUR~U3196AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360820	10/14/2009	IA	33.0	33		F	10/08/2009	Chest tightness, wheezing, cough, SOB. Onset 1degree after admin with s/s worsening as day progressed. Tx: nebulizer tx with ALBUTEROL									Y	09/24/2009	09/24/2009	0	None	PUB	PUB	None	None	Allergy Penicillin			1						1	Chest discomfort; Cough; Dyspnoea; Wheezing	FLU3~CSL LIMITED~05849111A~3~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360821	10/14/2009	PA	53.0	53		F		Low grade fever, chills & sweats night after vaccine administered (11:00 p.m - 2:30 a.m. chills, following by 1 hour of sweats). Low grade fever <100 persisted intermittently info afternoon of 10/7.									Y	10/06/2009	10/06/2009	0	N/A	OTH	PVT	Calcium Citrate, Vitamin D	No	Allergy to sulfa			1						1	Body temperature increased; Chills; Hyperhidrosis	FLU3~SANOFI PASTEUR~U3167BA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360823	10/14/2009	GA	22.0	22		F	09/27/2009	Patient called pharmacy 2 hrs post vaccine administration stating she was itching all over with no other symptoms. She was told to take Benadryl and call her MD.									Y	09/22/2009	09/22/2009	0	None	OTH	OTH	None	None	None listed or known			1						1	Pruritus generalised	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97839P2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360825	10/14/2009	TN	84.0	84		F	10/07/2009	5 minutes after receiving vaccination, pt came to pharmacist because she was itching all over on appearance, she was flushed all over, had no visible urticaria. She was having no difficulty breathing. Was given 50 mg diphenhydramine, with minor, if any, relief. Approximately 15-20 minutes later, she noted blurred vision and dizziness. Was taken to the emergency department, given Rx's for Prednisone and Diphenhydramine.				Y					Y	10/01/2009	10/01/2009	0		OTH	PUB	81mg Aspirin q day		Diabetes mellitus; allergic to morphine per pt report			1						1	Dizziness; Flushing; Pruritus generalised; Vision blurred	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P2A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360827	10/14/2009	TX	36.0			M	10/06/2009	None stated.														UNK	UNK						1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U3214AA~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360828	10/14/2009	TN	73.0	73		F	09/28/2009	4 inch irregular hematoma at injection site.				Y					Y	09/18/2009	09/19/2009	1	Increased INR	OTH	PUB	Warfarin		Anti-coag therapy	Rigors in arm~Pneumo (no brand name)~1~72.00~Patient		1						1	Injection site haematoma; International normalised ratio increased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360829	10/14/2009	MN	57.0	57		F	10/07/2009	Tenderness, swelling over left deltoid. Numbness in 2 of her fingers, thumb and index finger.									U	09/01/2009	09/08/2009	7	None	PVT	PVT	FLONASE; ALPHA STIM; NEXIUM; Ibu	None	None			1						1	Hypoaesthesia; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U3195AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360830	10/14/2009	CA	3.0	3		F	10/09/2009	L arm vaccine site 3 x 4 cm raised erythemia treated with BENADRYL.									Y	10/08/2009	10/08/2009	0		OTH	PUB	CLARITIN; ATARAY QUAR; ALBUTEROL		Positive food allergy; peanut; tuna; fish; no h/o egg allergy			1						1	Injection site erythema	FLU3~SANOFI PASTEUR~U3203AA~6~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360831	10/14/2009	MI	65.0	65		M	10/09/2009	The site of the pneumonia shot was red swollen, & very painful.  Had fever, chills and extreme fatigue.									Y	09/21/2009	09/21/2009	0		MIL	UNK		None	TERAZOSIN.			1						1	Chills; Fatigue; Injection site erythema; Injection site pain; Injection site swelling; Pyrexia	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1|PPV~UNKNOWN MANUFACTURER~~UNK~UN~UN~PNEUMO (NO BRAND NAME)~1	USA		Influenza
0360832	10/14/2009	MO	23.0	23		M	10/07/2009	Patient fainted, slumped in chair and seemed shaky. 911 was called immediately and pharmacist mentioned patient. Fire dept and EMS arrived monitored pt for 15+ minutes. Pt then was feeling well, refused ambulance and any more medical attention. Signed a release and walked out of store under his own free will.									Y	10/07/2009	10/07/2009	0		UNK	UNK						1						1	Muscular weakness; Syncope; Tremor	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360838	10/14/2009	NC	51.0	51		F	10/14/2009	Headache, sore arm, nausea, vomiting, diarrhea, nervous feeling, burning, chest tightness, not feeling well overall.									U	10/14/2009	10/14/2009	0		UNK	UNK		No	Asthma			1						1	Burning sensation; Chest discomfort; Diarrhoea; Headache; Malaise; Nausea; Nervousness; Pain in extremity; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360839	10/14/2009	TX	35.0	35		M	10/14/2009	as needle was pulled out of patient, arm began to swell and bruise; turned in to a hard, hot knot									U	10/14/2009	10/14/2009	0		UNK	UNK		none	none			1						1	Immediate post-injection reaction; Injection site haematoma; Injection site induration; Injection site swelling; Injection site warmth	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97838p2~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360840	10/14/2009	DE	62.0	62		F	10/14/2009	9:30 weak and dizzy no fever productive cough injection site warm  ,sore,no reddness									U	10/13/2009	10/13/2009	0	none	PUB	PUB		no	HBP acid reflux cholestersol			1						1	Asthenia; Dizziness; Injection site pain; Injection site warmth; Productive cough	FLU3~SANOFI PASTEUR~U3207AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360842	10/14/2009	IL	31.0	31		M	09/29/2009	None stated.										09/29/2009				UNK	UNK						1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U3200AA~2~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360845	10/14/2009	NJ	12.0	12		M	10/08/2009	Two days after vaccinations, was seen in the office complaining of chills, headache and fever as high as 104 degrees about 24 hours after vaccines. Symptoms resolved about 12 hours later. He also had redness at the injection site.				Y					Y	10/06/2009	10/07/2009	1	None	PVT	PVT	TOPAMAX; SYNTHROID; RISPERDAL; ZONEGRAN; BENADRYL; melatonin	None	Asthma, bipolar disorder			1						1	Chills; Headache; Injection site erythema; Pyrexia	FLU3~SANOFI PASTEUR~UT3172BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|MNQ~SANOFI PASTEUR~U3048AA~1~IM~LA~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~UF499BA~1~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0360846	10/14/2009	NC	33.0	33		F	10/01/2009	Extreme arm soreness. Eye redness/swelling (right eye -> same side as injection).									U	09/30/2009	10/01/2009	1		OTH	OTH	LOESTRIN; SYNTHROID; NEXIUM; XYZAL		GERD, hypothyroidism, allergies			1						1	Eye swelling; Ocular hyperaemia; Pain in extremity	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA278AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA		Influenza
0360847	10/14/2009	WI	76.0	76		F	10/07/2009	Rash and itching about 8 hours after receiving vaccine.  Resolved itself within about 18 hours.  Pt states that they have had numerous flu shots without reaction before.									Y	10/06/2009	10/06/2009	0	None	OTH	PUB	Unknown	None				1						1	No reaction on previous exposure to drug; Pruritus; Rash	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P2~UNK~UN~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360849	10/14/2009	NY	11.0	11		F	10/06/2009	Watery eyes; rhinorrhea / nasal congestion; body aches.				Y					U	10/03/2009	10/04/2009	1	none	UNK	PUB	none	none	none			1						1	Lacrimation increased; Nasal congestion; Pain; Rhinorrhoea	FLUN3~MEDIMMUNE VACCINES, INC.~500705P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0360850	10/14/2009	MD	5.0	5		F	10/09/2009	Got vax 3:40 P-woke up 1:30 A, T 104, vomited. Went to ER-gave IV after 2nd vomit episode then temp was 100 degrees-was given TAMIFLU q 12 hours-attends elem. school. (Middle school had H1N1 outbreak this week).				Y					U	10/08/2009	10/09/2009	1		PUB	PUB		None noted	None noted			1						1	Body temperature increased; Vomiting	FLU3~SANOFI PASTEUR~U3185AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360851	10/14/2009	MA	1.04	1	.0	F	10/08/2009	Nasal congestion. FLUMIST given to < 2 yo.									U	09/26/2009	10/01/2009	5		PVT	PUB		None	None			1						1	Nasal congestion	FLUN3~MEDIMMUNE VACCINES, INC.~500695P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360852	10/14/2009	CA	37.0	37		F	09/30/2009	Pt received flu shot at about 12PM: complained of some pain during injection, but no inflammation. Pt called pharmacy at 2pm with tingling/pain in left hand, no injection site pain. Pt advised to take TYLENOL and see MD if necessary. F/u with pt next day, no more tingling but still some pain. Will follow-up with pt in several days-no more pain.									Y	09/30/2009	09/30/2009	0		OTH	PVT		None	None			1						1	Injection site pain; Pain in extremity; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360853	10/14/2009	WA	2.0	2	.2	F	10/07/2009	Pt came into office w/a raised, red circle on left upper thigh. Pt complained of pain in her leg. Vaccine administered in area was flu.				Y					U	10/05/2009	10/05/2009	0		PVT	PUB						1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~SANOFI PASTEUR~U3201AA~1~UN~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB327AA~1~UN~RL~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~0992Y~2~SC~UN~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0360854	10/14/2009	NM	44.0	44		M	10/09/2009	Left arm-swollen, red, tender-PNEUMOVAX site. Approx. 1.5 hours after vaccine.									U	10/07/2009	10/07/2009	0		OTH	PVT	Warfarin					1						1	Injection site erythema; Injection site pain; Injection site swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98445P1~UNK~UN~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~0472Y~UNK~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360855	10/14/2009	CO	54.0	54		F	10/09/2009	Immunization administered at top of shoulder joint (not in arm muscle) into shoulder area w/ little tissue, significant joint discomfort & immobility now. Diagnosis ongoing.				Y					N	09/17/2009	09/19/2009	2	MRI shows tendonitis, bursitis	OTH	PVT	None	None	None			1						1	Arthralgia; Drug administered at inappropriate site; Injected limb mobility decreased	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~66521011202~1~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360856	10/14/2009	IN	10.0	10		F	10/14/2009	Pt complaining of Headache and itchy throat. Pt crying and shaking.  0.25cc of Epi administered to pt sq at 6:45pm. No noted improvement in pt symptoms. 1cc Benadryl given IM at 6:55pm. Within 5 min pt stating that throat was feeling better. Dr contacted and pt instructed to go to ER for evaluation				Y					Y	10/12/2009	10/12/2009	0	No tests done. Vitals checked at ER. Stable	UNK	UNK	No meds listed	None listed	History of egg white allergy. Child eats egg containing foods often without a problem. Also allergic to shrimp.			1						1	Crying; Headache; Throat irritation; Tremor	FLU3~SANOFI PASTEUR~U3188AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360857	10/14/2009	NY	36.0	36		F	10/12/2009	Received influenza vaccine at 845 AM, experienced localized redness at injection site, (+) itchy neck, throat scratchy (+) SOB, (-) CP. Given epidase at clinic site. Taken to hospital - Tx with BENADRYL and Prednisone.				Y					Y	10/08/2009	10/08/2009	0	None	PUB	PVT		None	Environmental			1						1	Dyspnoea; Injection site erythema; Pruritus; Throat irritation	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA259AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLULAVAL)~1	USA	Emergency room visit	Influenza
0360863	10/14/2009	CA	40.0	40		F	09/28/2009	Pt felt dizzy, lips turned blue and BP was low after administering shot. Called 911 and sent her to hosp. Followed up after 2 days and pt felt fine. Had low BG too.				Y					Y	09/25/2009	09/25/2009	0	Not available to us.	OTH	OTH		Delivered baby, so anemic, post partum, BP down, BG down	Post partum, delivered a baby/C-section on 9/14/09			1						1	Blood glucose decreased; Cyanosis; Dizziness; Hypotension	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P1~1~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360864	10/14/2009	TN	79.0	79		M	10/02/2009	Swelling and bruising down left arm to wrist.									U	09/23/2009	09/25/2009	2		OTH	PUB			None			1						1	Contusion; Oedema peripheral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97841P1~7+~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360867	10/14/2009	TX	37.0			M	10/06/2009	None Stated.														UNK	UNK						1						1	Unevaluable event	FLU3~SANOFI PASTEUR~U3214AA~UNK~IJ~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360868	10/14/2009	NY	31.0	31		F	10/08/2009	Pt started w/lightheadedness, then progressed to difficulty breathing.				Y					Y	10/08/2009	10/08/2009	0		OTH	PVT						1						1	Dizziness; Dyspnoea	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97846P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360870	10/14/2009	MD	11.0	11		M	10/14/2009	Positive nose bleed. Fever to 103, headaches, light sensitivity, myalgias, back pain, neck soreness (Neck supple on exam) within 24 hrs after receiving vaccine.				Y						10/12/2009	10/12/2009	0	None	PUB	PUB		None	Mild asthma none since age 3 yrs			1						1	Back pain; Epistaxis; Headache; Myalgia; Neck pain; Photophobia; Pyrexia	FLUN3~MEDIMMUNE VACCINES, INC.~500705P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Emergency room visit	Influenza
0360871	10/14/2009	IL	9.0	9		M	10/14/2009	Status had fever of 102 and vomiting x 1.									Y	10/12/2009	10/12/2009	0		UNK	UNK						1						1	Pyrexia; Vomiting	FLU3~SANOFI PASTEUR~~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360872	10/14/2009	CA	82.0	82		M	10/14/2009	pt. received influenza flu shot on 10/06/09 via a Public Health Flu Outreach at the Center. Flu shot manufactured by Sanofi Pasteur. Fluzone Lot #U3186AA Exp. June 30,2010. Pt. informed center administrator on 10/13/09 that his Rt. upper arm where he received the flu shot had bruised up more than usual. I am the Public Health Nurse in charge of that outreach that day so I called the pt. to find out what symptoms he was having.  Pt. c/o of right arm pain x 3 days, on a scale of 1-10, his pain was an 8.  He states that it hurt to elevate his arm but now 8 days after his pain is gone.  Pt. denied increased swelling, warmth,or pus at the site.  The senior center sent my a picture via my email.  The upper right arm appears with diffuse red/purple bruising approx 6-7 inches in length and approx 4 inches wide.  Pt.states he is on aspirin therapy.  Unable to obtain info. who gave him the shot d/t consent forms have been turned into the immunization program. Pt. is concerned about his bruising and will attempt to see his private doctor today 10/14/09. Rt. arm has no pain and pt. can move it without a problem.									U	10/06/2009	10/07/2009	1		UNK	UNK	diabetic med( name unknown) aspirin HTN med(name unknown)	denies	diabetes, HTN, pt. is on aspirin therapy			1						1	Injection site haematoma; Injection site pain; Pain	FLU3~SANOFI PASTEUR~U3186AA~7+~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360873	10/14/2009	IL	60.0	60		F	10/14/2009	States had slight fever it felt nauseated.									Y	10/12/2009	10/12/2009	0		PUB	UNK						1						1	Nausea; Pyrexia	FLU3~SANOFI PASTEUR~U326L00A~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360874	10/14/2009	TN	28.0	28		M	10/14/2009	10/13/09 MedImmune Flu Mist at 630PM.  C/O dizziness shortly after.  Observation:  VS, P 84, R 20, B/P 130/80:  Color good after having pt rest with cool cloth.  He was able to stand and walk with steady gait.  Refuse - 911 ask to allow friend to be called.									Y	10/13/2009	10/13/2009	0	Flu Mist Clinic	PUB	PUB	Unknown	Brief dizziness	NKDA			1						1	Dizziness	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500757P~1~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA		Influenza
0360875	10/14/2009	IA	11.0	11		M	10/13/2009	Patient received H1N1 as flu mist at clinic on October 9, 2009 at 8 AM.  Patient developed fever at 101.5F Friday night.  Then developed headache and congestion on Saturday, October 10, 2009.  Presented to clinic 10/12/09.									N	10/09/2009	10/09/2009	0	Pt seen 10/12/09 no influenza sxs and + rapid influenza A test *which has had many children ill with influenza sxs - suspect community acquired illness.	PUB	PUB	None	None	None			1						1	Headache; Influenza serology positive; Pyrexia; Upper respiratory tract congestion	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500759T~1~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA		Influenza
0360877	10/14/2009	PA	4.0	4		F	10/14/2009	Woke up lethargic, with severe headache, and fever (Temp 101.5).  Neck supple.  Advised tylenol for H/A & fever.  Called back for office visit that evening.  Temp up to 102.5 oral with eye pain, head pain top & front of head.				Y					U	10/08/2009	10/12/2009	4		PVT	PVT		No.	None.			1						1	Eye pain; Headache; Lethargy; Pyrexia	DTAP~SANOFI PASTEUR~C3142AA~5~IM~LA~DTAP (DAPTACEL)~1|FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500754P~1~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1|MMR~MERCK & CO. INC.~0764Y~2~SC~LA~MEASLES + MUMPS + RUBELLA (MMR II)~1	USA	Emergency room visit	Influenza
0360879	10/14/2009	MD	45.0	45		F		C/o lightheaded, dizziness, numbness down L arm. BP 170/90. Takes TOPROL 25 mg qd hs. No other meds. Repeat BP after 15 min 140/80.									Y	09/30/2009	09/30/2009	0		PUB	PUB	Blood pressure medication	None	High blood pressure			1						1	Blood pressure increased; Dizziness; Hypoaesthesia	FLU3~SANOFI PASTEUR~U3210AA~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360880	10/14/2009	NE	25.0	25		F	10/09/2009	Pt. had hives and itching approx. 5 hrs. post administration.									Y	10/07/2009	10/08/2009	1	None	PVT	UNK	No	No	Penicillin & Sulfa			1						1	Pruritus; Urticaria	FLU3~SANOFI PASTEUR~UP002AA~7+~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500751P~1~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA		Influenza
0360883	10/14/2009	CA	45.0	45		M	10/14/2009	neck spasms, severe pain, nausea, shooting pain from neck to injection site on left arm, including injection site										10/06/2009	10/12/2009	6	None	UNK	PVT		no	high blood pressure			1						1	Injection site pain; Muscle spasms; Nausea; Neck pain; Pain	FLUX~UNKNOWN MANUFACTURER~~1~IJ~LA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360884	10/14/2009	MA	28.0	28		F	10/14/2009	This occurred at a private pay clinic at place of employement.  First time flu shot-denied any allergies. Ten min. after injection, patient said she felt funny and she had hives covering her upper torso.  No resp. diificulties.  Gave Benedryl 50 mg po and water. B/P 120/80, pulse 80's.  After 30 min. hives resolved b/p 100/66 ate an apple, felt fine, went back to work.									Y	10/07/2009	10/07/2009	0	none	UNK	UNK	none	none	none			1						1	Feeling abnormal; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA456AA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0360885	10/14/2009	FL	68.0	68		M	10/14/2009	DULL HEADACHES THAT START IN A.M. AND LAST ALL DAY EVERY DAY. TODAY INCLUDED.										10/02/2009	10/05/2009	3		UNK	UNK		NO				1						1	Headache	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360886	10/14/2009	TX	18.0	18		M	10/14/2009	Mother called stating son had gone into bathroom at approximately 3:00 p.m. and that she heard a loud noise. Upon investigating she found child was passed out in stiff position with hands curled on chest. Patient was like this for 5 - 10 minutes and then it resolved. Representative spoke with patient via speaker phone with Supervisor present to confirm that patient was alert and oriented by requesting age and location of school. Patient responded in the affirmative by stating he was 18 years old and attended High School. The patient stated he was feeling ok, but still felt sleepy and that his head hurt. Mother stated she could not palpate or see any bumps, bruising, or bleeding. Representative recommended to have patient go to E.R. of their choice and the mother and the father of the client agreed.				Y					U	10/14/2009	10/14/2009	0		UNK	UNK		NKDA. No fever, No illness.	None.			1						1	Headache; Loss of consciousness; Musculoskeletal stiffness; Somnolence	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98434P1~2~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1|TDAP~SANOFI PASTEUR~UF499AA~1~IM~LA~TDAP (ADACEL)~1	USA	Emergency room visit	Influenza
0360887	10/14/2009	KY	34.0	34		F	10/14/2009	102.5 sudden fever, chills, could not get warm, myalgia (intense contraction of leg/calf muscle for 2 hours), nausea, achy all over entire body, could not move from bed, profuse sweating, no sore arm -typically i have a sore arm for 3 days									Y	10/07/2009	10/07/2009	0		PVT	UNK	demulen (birth control)	none	none			1						1	Bedridden; Chills; Feeling cold; Hyperhidrosis; Muscle contractions involuntary; Myalgia; Nausea; Pain; Pain in extremity; Pyrexia	FLU3~CSL LIMITED~08649111A~UNK~~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360888	10/14/2009	MA	22.0	22		F	10/14/2009	Match erythemitis rash on hands traveling to wrist followed by itching and stinging									Y	10/14/2009	10/14/2009	0	observation and subjective description by patient	PUB	PUB	Lo-estrin  qd Minocyclin bid Zyrtec 10mg  qd	Healthy - no known symptoms of illness	Allergies to pollen, dust, animals and seasonal allergies			1						1	Pain; Pruritus; Rash erythematous	FLU3~SANOFI PASTEUR~U3188AA~1~ID~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360890	10/14/2009	KY	64.0	64		F	10/14/2009	Patient presented with local site irritation which included a few raised bumps and redness.									Y	10/14/2009	10/14/2009	0		PUB	UNK			n/a			1						1	Injection site irritation; Rash erythematous	FLU3~CSL LIMITED~08549111a~3~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360891	10/14/2009	MA	39.0	39		M	10/14/2009	severe myalgias, weakness, mild headache  01/04/10 MR and DC summary received for DOS 10/13/09-10/15/09.  DX: myositis, influenza virus, vaccine adverse reaction. Pt c/o muscle pain and weakness. Pt had progressive achy muscle in arms and legs, HA, runny nose, dry throat. On examination: Pt A Ox3 and no nuchal rigidity. Tx: Vit D, acetaminophen. Pt discharged home in good condition.					Y	3			Y	10/09/2009	10/10/2009	1	CPK 2673, cbc normal, electrolytes normal, AST 102	UNK	UNK		DX studies: CPK: 2673, hypocalcemia, LFTs abnormal, elevated AST; CXR: normal.	PMH: asthma, allergic rhinitis, Allergies: NKDA.			1						1	Aspartate aminotransferase increased; Asthenia; Blood creatine phosphokinase increased; Blood electrolytes normal; Full blood count normal; Headache; Myalgia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97845P1~1~IM~RA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Hospitalisation	Influenza
0360893	10/14/2009	SC	57.0	57		M	10/14/2009	Headache, vomiting, diarrhea. Lasted 6 hours till I started getting faint and having chest pains. Called 911.				Y					Y	10/06/2009	10/06/2009	0	Dehydration, severe reaction to Flu shot.	UNK	UNK		No				1						1	Chest pain; Dehydration; Diarrhoea; Dizziness; Headache; Immunisation reaction; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360895	10/14/2009	VA	48.0	48		M	10/14/2009	Began coughing and chest became tight and then I started itching inside my chest cavity around 12:30 PM.  At 1:15 PM, I took a Benadryl tablet and after about 30 minutes the itching and coughing subsided, but then my lips began to swell and get numb feeling. I called my Dr's office to find out if I should do anything else and the suggestion was given to go to the ER should I find difficulty in breathing.  My throat feels just slightly swollen, but no difficulty in breathing. Took another Benadryl @ 5:15 p.m.  Am now hoarse and cough occassionally.									U	10/14/2009	10/14/2009	0		UNK	UNK	Antacid.	No illness @ time of injection.	Allergic to aspirin (causes nose bleeds). Was tested 30 yrs ago and advised of being allergic to eggs; but eat them without adverse allergic reaction. Pollen allergies.			1						1	Chest discomfort; Cough; Dysphonia; Hypoaesthesia oral; Lip swelling; Pharyngeal oedema; Pruritus	FLUX~UNKNOWN MANUFACTURER~~UNK~~~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360896	10/14/2009	MI	5.0	5		M	10/14/2009	Vomiting, fever, diarrhea										10/13/2009	10/14/2009	1		UNK	UNK		no	none			1						1	Diarrhoea; Pyrexia; Vomiting	FLUN3~MEDIMMUNE VACCINES, INC.~~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360897	10/14/2009	NY	53.0	53		F	10/14/2009	Fever (101.5), chills, body aches, headache, bloodshot eyes, general feeling of malaise, loose bowels, pain in needle site (right arm that pneumonia vaccine was given only, left arm flu shot fine), unable to lift arm above head, still extremely painful 36 hours later.									Y	10/13/2009	10/13/2009	0		UNK	PVT	Albuterol	No	Asthma			1						1	Chills; Diarrhoea; Headache; Injected limb mobility decreased; Injection site pain; Malaise; Ocular hyperaemia; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U3199AA~2~IM~LA~INFLUENZA (SEASONAL) (FLUZONE)~1|PPV~MERCK & CO. INC.~1125X~1~IM~RA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360898	10/14/2009	OK	46.0	46		F	10/14/2009	Fever, chills, cough and vomiting.									Y	10/09/2009	10/09/2009	0		PVT	UNK		no	no			1						1	Chills; Cough; Pyrexia; Vomiting	FLUX~UNKNOWN MANUFACTURER~~1~IJ~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360899	10/14/2009	MO	39.0	39		M	10/14/2009	Numbness of face, lips, tongue on left side of face. Symptoms consistent with Bell's Palsy.  10/26/09:  Emergency Room records received for date of service 10/14/09.  DX:  Bell's Palsy.   Assessment:  Presented to the ER with Left side facial drooping and numbness, unable to close left eye completely, noticed liquid dribbling from left side of mouth.  Treated with prednisone and acyclovir.  Discharged to home.				Y						10/14/2009	10/14/2009	0	10/26/09:  Emergency Room records received for date of service 10/14/09.  Labs and diagnostics:  None	UNK	UNK		Possible sinus cold.	Hypertension. 10/26/09:  Emergency Room records received for date of service 10/14/09.  PMH:  HTN, allergic to codeine.			1						1	Facial palsy; Hypoaesthesia facial; Hypoaesthesia oral	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~960326P~UNK~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360900	10/14/2009	CA	0.5	0	.6	F	10/14/2009	Fever 103.2 at night which resolved the next day. No rash this time.									Y	10/05/2009	10/05/2009	0	none	UNK	PUB	NONE	none	Had consolable crying, rash and temp < 102 with 4 month old Immunizations. On exam prior to IZ had eczema.	RASH FEVER <102, CRYING CONSOLABLE~DTaP + HepB + IPV (Pediarix)~2~0.33~Patient|FEVER<102, CRYING, RASH~Pneumo (Prevnar)~~0.33~Pa		1						1	Pyrexia	DTAPHEPBIP~GLAXOSMITHKLINE BIOLOGICALS~ACZ1B187AA~3~IM~RL~DTAP + HEPB + IPV (PEDIARIX)~1|FLU3~SANOFI PASTEUR~UT3178CA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1|PNC~PFIZER\WYETH~D59297~3~IM~LL~PNEUMO (PREVNAR)~1|RV5~MERCK & CO. INC.~O32OY~3~PO~MO~ROTAVIRUS (ROTATEQ)~1	USA		Influenza
0360901	10/14/2009	CO	65.0	65		F	10/14/2009	Body ache, sharp joint pain, headache, nausea, vomiting, diarrea, chills.										10/13/2009	10/14/2009	1		UNK	UNK		None	None			1						1	Arthralgia; Chills; Diarrhoea; Headache; Nausea; Pain; Vomiting	FLUX~UNKNOWN MANUFACTURER~~UNK~IJ~RA~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA		Influenza
0360902	10/14/2009	LA	9.0	9		M	10/14/2009	Sweating, flushing of face, and dermatographism treatment Benadryl and Motrin.										10/14/2009	10/14/2009	0		UNK	UNK		no	Rocephin; local reation to seasonal flu vaccine several years ago	local reaction~Influenza (Seasonal) (no brand name)~~0.00~Patient		1						1	Flushing; Hyperhidrosis; Mechanical urticaria	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500756P~UNK~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1	USA		Influenza
0360903	10/14/2009	LA	42.0	42		F	10/14/2009	metallic taste in mouth				Y						10/14/2009	10/14/2009	0	cbc, nasal swab for influena, chem and liver panel, stool culture	PVT	PVT		no	none			1						1	Dysgeusia	FLU(H1N1)~SANOFI PASTEUR~UP001AA~UNK~IM~LA~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI))~1	USA	Emergency room visit	Influenza
0360905	10/14/2009	OR	42.0	42		F	10/14/2009	shortness of breath, tightness in chest, pain in chest				Y						10/14/2009	10/14/2009	0		UNK	UNK		None.	None.			1						1	Chest discomfort; Chest pain; Dyspnoea; Chest discomfort; Dyspnoea; Pruritus generalised	FLUN(H1N1)~MEDIMMUNE VACCINES, INC.~500751P~1~IN~NS~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))~1|FLUN3~MEDIMMUNE VACCINES, INC.~500751P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~2	USA	Emergency room visit	Influenza
0360906	10/14/2009	IL	39.0	39		M	10/05/2009	A serious adverse event report of bacterial pneumonia and non-serious adverse event report of achy, temperature, and cough has been received from a registered nurse concerning a 39-year-old male subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 18-Sep-2009. The patient received a total of one dose of FLUMIST before the onset of the event. The patient felt achy several days after receiving FLUMIST. Then he had a temperature and cough that  progressed. The patient was hospitalized with bacterial pneumonia on an unknown date. The events were resolved on 10/05/2009.					Y				Y	09/18/2009	09/20/2009	2		OTH	OTH	Concomitant Drug(s) Not reported				MEDI0009001	1						1	Body temperature increased; Cough; Pain; Pneumonia bacterial	FLUN3~MEDIMMUNE VACCINES, INC.~500695P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA	Hospitalisation	Influenza
0360907	10/14/2009	MD	7.0	7		M	09/29/2009	A spontaneous report of asthma attack has been received from a health professional concerning a seven-year-old male, subsequent to FLUMIST.  Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 18-Sep-2009. The patient received a second dose of FLUMIST before the onset of the event on 29-Sep-2009. Eleven days after receiving the first dose of FLUMIST, on 29-Sep-2009, the patient developed an asthma attack after receiving a second dose. The outcome and causality were not reported for the event of asthma attack. The sponsor considers the events of inappropriate schedule of vaccine administered and asthma attack medically important events.									U	09/18/2009	09/29/2009	11		OTH	OTH	Concomitant Drug(s) Not Reported				MEDI0008962	1						1	Asthma; Inappropriate schedule of drug administration	FLUN3~MEDIMMUNE VACCINES, INC.~500677P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360909	10/14/2009	MI	17.0	17		F		Patient 17 yrs old. AFLURIA indicated for 18 and above.										10/05/2009				OTH	PVT			Unknown			1						1	Inappropriate schedule of drug administration; Unevaluable event	FLU3~CSL LIMITED~08549111A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360910	10/14/2009	MD	8.0	8		M	10/19/2009	Bloody nose in L nostril on 10-8-09 and 10-10-09, mod amount bleeding then stopped. C/o bubbly feeling in bridge of nose when nose stopped bleeding-10/12/09 bubbly.									Y	10/01/2009	10/08/2009	7		OTH	PUB	None	None	None			1						1	Epistaxis	FLUN3~MEDIMMUNE VACCINES, INC.~500705P~2~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360911	10/14/2009	NJ	75.0	75		F	10/13/2009	Patient left message stating that she had a bad reaction, arm was red, really swollen, painful and vomiting. She told me she had taken BENADRYL-still a little painful but swelling had went down.									U	09/29/2009	09/30/2009	1		OTH	PVT		None	None			1						1	Erythema; Immunisation reaction; Oedema peripheral; Pain in extremity; Vomiting	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97848P1C~2~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1|PPV~MERCK & CO. INC.~P6324~2~IM~UN~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360912	10/14/2009	WA	54.0	54		M	10/19/2009	Body aches & fatigue X 3 days.  Symptoms developed 3 hours after receiving the inj.									Y	10/12/2009	10/12/2009	0	No	PVT	PVT		None	None			1						1	Fatigue; Pain	FLU3~CSL LIMITED~02149211A~1~IM~LA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360914	10/14/2009	NY	42.0	42		F	10/14/2009	Redness, swelling, pain 5 x 4 inch at injection site, muscle aches, limited range of motion.									N	10/06/2009	10/07/2009	1	N/A	PVT	UNK		None	Asthma, environmental allergies, HTN	cellulitis~Tetanus Toxoid, adsorbed (no brand name)~UN~31.00~Patient		1						1	Injected limb mobility decreased; Injection site erythema; Injection site pain; Injection site swelling; Myalgia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA470CA~1~IM~LA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0360915	10/14/2009	AZ	29.0	29		F	10/14/2009	Rash itching.									U	10/14/2009	10/14/2009	0		OTH	OTH						1						1	Rash pruritic	FLU3~CSL LIMITED~08449111A~UNK~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360917	10/14/2009	TN	13.0	13		F	10/14/2009	Pt. broke in hives on 10-8-09 after getting vaccines on 10-6-09.				Y					Y	10/06/2009	10/08/2009	2		PVT	PVT		Sinusitis				1						1	Urticaria	FLUN3~MEDIMMUNE VACCINES, INC.~500709P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB327AA~2~UN~RL~HEP A (HAVRIX)~1|VARCEL~MERCK & CO. INC.~0848Y~2~UN~LA~VARICELLA (VARIVAX)~1	USA	Emergency room visit	Influenza
0360918	10/14/2009	NH	17.0			M	10/14/2009	Mom stated that pt had diarrhea the next day. Dad said he also had diarrhea, but didn't get the flu vaccine.									Y					OTH	OTH	None	None	None			1						1	Diarrhoea	FLU3~SANOFI PASTEUR~UT3172AA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360919	10/14/2009	TX	48.0	48		F	10/14/2009	About 5 days after vaccination index finger on that arm c/forefinger began to tingle with pins and needles feeling. Now has aching in + up of arm and forearm and muscle twitching has this constant feeling.									U	09/29/2009	10/04/2009	5	Patient says she may be contacted directly	OTH	PVT	None	None	None - very healthy	None~ ()~~0.00~Patient|None~ ()~~0.00~Sibling		1						1	Muscle twitching; Pain; Paraesthesia	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98732P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360920	10/14/2009	MO	62.0	62		M	10/11/2009	Pt claims saw floaters at time of injection. Pt was asked to stay for 15 min. Pt called back 30 minutes later and stated he was experiencing numbness of face, forehead and cheek. Directed pt to ER. At ER pt was given BENADRYL and PEPCID.				Y					Y	10/10/2009	10/10/2009	0		PUB	PVT		None	None			1						1	Hypoaesthesia facial; Visual impairment	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~97840P1~1~UN~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360921	10/14/2009	AK	67.0	67		F	10/14/2009	Patient had rash all over body 2 days after receiving influenza injection. Went ER 2 days later (4 days post-injection) - Received hydrocortisone cr and BENADRYL at ER.				Y					Y	10/07/2009	10/09/2009	2		OTH	PVT						1						1	Rash generalised	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98441P1~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360922	10/14/2009	NM	85.0	85		F		Tongue swelled 32 hrs after injection. Blister in mouth 32 hrs after injection. As of 10/14/09 7:00 PM tongue still swollen - Patient taking BENADRYL.									U	10/12/2009	10/13/2009	1		OTH	OTH						1						1	Oropharyngeal blistering; Swollen tongue	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~98445P1~UNK~IM~UN~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360924	10/14/2009	NJ	23.0	23		M	10/09/2009	Red at site.- T high 102 degrees, Heart rate high 140- 160 - BP high 146/94 - TYLENOL ES tabs 2 po - SV started, BENADRYL 50 mg QV sent to ER				Y					U	10/07/2009	10/08/2009	1		OTH	PVT	None	None	Asthma			1						1	Body temperature increased; Heart rate increased; Hypertension; Injection site erythema; Blood pressure increased; Body temperature increased; Cellulitis; Chills; Electrocardiogram ST segment depression; Electrocardiogram abnormal; Heart rate increased; Injection site erythema	PPV~MERCK & CO. INC.~1134Y~1~IM~RA~PNEUMO (PNEUMOVAX)~1|FLU3~CSL LIMITED~~UNK~UN~UN~INFLUENZA (SEASONAL) (AFLURIA)~2|PPV~MERCK & CO. INC.~1134Y~UNK~IM~RA~PNEUMO (PNEUMOVAX)~2	USA	Emergency room visit	Influenza
0360930	10/14/2009	MI	66.0	66		M	10/09/2009	Dry throat - First night (10-609) - Rash w/Bumps - Started day two -mildly - Full blown by noon - day 3				Y						10/06/2009	10/07/2009	1		PUB	PVT		None	None	None~ ()~~0.00~Patient		1						1	Dry throat; Rash papular	FLUX~UNKNOWN MANUFACTURER~~UNK~UN~UN~INFLUENZA (SEASONAL) (NO BRAND NAME)~1	USA	Emergency room visit	Influenza
0360931	10/15/2009	IL	60.0	60		M	10/15/2009	Patient has extensive severe rash on trunk, arms, legs. Itching and Pain phamacist recommended 2 Benadryl at 4-6 hr interval. Also apply Benadryl lotion to affected area. This reaction unknown to patient having received vaccine for numerous previous years. He received vaccine without preservative and in previous years was with preservative.									N	10/12/2009	10/12/2009	0		UNK	UNK	none of these apply	None	None	none~ ()~~0.00~Patient		1						1	Pain; Pruritus; Rash; No reaction on previous exposure to drug; Rash generalised	FLU3~CSL LIMITED~07849111A~UNK~IJ~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|FLU3~CSL LIMITED~07849111A~1~IM~UN~INFLUENZA (SEASONAL) (AFLURIA)~2	USA		Influenza
0360932	10/15/2009	NY	61.0	61		F	10/15/2009	States 3 days after vaccine, she developed hives, severe pruritis, needed IM kenalog and po Benadryl, given by PMD				Y					Y	10/07/2009	10/10/2009	3		PUB	UNK	None Ate eggs same day as received vaccine	none reported	Zometa allergy			1						1	Pruritus; Urticaria	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA449BA~UNK~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA	Emergency room visit	Influenza
0360933	10/15/2009	OH	52.0	52		F	10/15/2009	Pain in chest area and middle back as evening progressed pain spead into sides and abdomin area.Had muscle spasms. hurt so bad couldn't lay daown or sit.could not apply presure to any midrif area. I took a couple of doses of Advil and about 10:00 pm I finally was able to rest.				Y					N	10/14/2009	10/14/2009	0	not yet	PUB	UNK		no	no			1						1	Abdominal pain; Activities of daily living impaired; Back pain; Chest pain; Muscle spasms; Pain	FLU3~SANOFI PASTEUR~u319400~2~~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA	Emergency room visit	Influenza
0360934	10/15/2009	SC	3.0	3		M	10/15/2009	Mother reports that child was playing in playground 3 hours after vaccine (mist) was given.  Child reported to have blood on face and arms.  After cleaning, found blood coming from nose.  Child did not report injury to nose.  Was not in pain.  Mother unsure how much child bled or for how long.  She relates that the bloody nose was from the Flu Mist.  Unsure whether dose was split between nostrils or given in one dose to one nostril.									Y	10/01/2009	10/01/2009	0	NONE	MIL	MIL	NONE	None reported.	Not able to find information in chart.			1						1	Epistaxis	FLUN3~MEDIMMUNE VACCINES, INC.~500719P~1~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1	USA		Influenza
0360935	10/15/2009	NY	39.0	39		F	10/15/2009	On 10/08 patient developed pain on right side of neck.  This was followed by swollen lymph nodes in the same area that appeared red.  10/14 left side of neck had swollen red appearing lymph nodes with no pain.  Denies sore throat, ear pain, fever.  She also had malaise but thought it may be due to her menstrual cycles since that is usual.  She also reported on 10/8 bone pain in left shoulder same time as the beginning of the swollen lymph nodes.  She has not seen her physician yet, but will call for an appointment today.									U	10/06/2009	10/08/2009	2	None	UNK	UNK		No	No			1						1	Erythema; Lymphadenopathy; Malaise; Musculoskeletal pain; Neck pain	FLU3~CSL LIMITED~08249111A~1~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1	USA		Influenza
0360937	10/15/2009	CA	68.0	68		M	10/15/2009	extreme dizziness									Y	10/14/2009	10/15/2009	1	dizziness somewhat subsided by 7:30 AM	UNK	UNK	none to all the questions above	none	none			1						1	Dizziness	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~~1~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA		Influenza
0360938	10/15/2009	PA	35.0	35		F	10/15/2009	10-14-09 @ 09:30 - received inoculation right deltoid; 10-14-09 @ 17:00 - began aching to right lower arm with some muscle fatigue of right arm.  10-15-09 @ 06:00 - awoke with aching/muscle fatigue right arm, right side to right leg - no weakness.  No erythema or bruising.									N	10/14/2009	10/14/2009	0		OTH	OTH	CYMBALTA; VICODIN; GABAPENTIN.	None	Fibromyalgia; Depression.			1						1	Muscle fatigue; Pain	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLUA470BA~1~IM~RA~INFLUENZA (SEASONAL) (FLUARIX)~1	USA		Influenza
0360940	10/15/2009	FL	32.0	32		F	10/13/2009	45min past influenza vaccine was admin - Pt began to feel lips swell, hot and dizzy.				Y					Y	10/01/2009	10/01/2009	0	None	PUB	PVT		None	None			1						1	Dizziness; Feeling hot; Lip swelling	FLU3~NOVARTIS VACCINES AND DIAGNOSTICS~PB439P1~UNK~IM~LA~INFLUENZA (SEASONAL) (FLUVIRIN)~1	USA	Emergency room visit	Influenza
0360941	10/15/2009	AR	0.03	0	.0	M	10/14/2009	Erythematous induration +- 15 cm in diameter with warmth.									N	10/13/2009	10/14/2009	1		PVT	UNK			Allergy injections			1						1	Induration; Rash erythematous; Skin warm	DTAP~SANOFI PASTEUR~C3084AA~4~IM~RL~DTAP (DAPTACEL)~1|FLU3~SANOFI PASTEUR~U3187AA~1~IM~LL~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360942	10/15/2009	NC				F		Left arm localized swelling the size of a grapefruit. Swollen lymph nodes in armpit very tender. Numbness in left side of throat and ear. Improving									U	10/13/2009	10/13/2009	0		OTH	PUB	None	None	Penicillin, Ceclor, cipro			1						1	Hypoaesthesia facial; Lymph node pain; Lymphadenopathy; Oedema peripheral; Pharyngeal hypoaesthesia	FLU3~GLAXOSMITHKLINE BIOLOGICALS~AFLLA275AA~1~UN~RA~INFLUENZA (SEASONAL) (FLULAVAL)~1|PPV~MERCK & CO. INC.~08234~1~UN~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360943	10/15/2009	VA	18.0	18		F	10/13/2009	Immediately after administration all the above vaccine she became limp then stiff - eyes rolled up - fainted - helped to the floor within a minute she recovered fully - vitals signs normal. No treatment given - paramedics came - no medications given - stable.									Y	10/10/2009	10/10/2009	0	None	PVT	PUB	Uses Albuterol HFA	Follow-up for asthma	Asthma; Allergic rhinitis : Dermatitis; Suicide attempt			1						1	Gaze palsy; Hypotonia; Immediate post-injection reaction; Musculoskeletal stiffness; Syncope	FLU3~SANOFI PASTEUR~U3185AA~2~IM~UN~INFLUENZA (SEASONAL) (FLUZONE)~1|HEPA~GLAXOSMITHKLINE BIOLOGICALS~AHAVB334BA~1~IM~UN~HEP A (HAVRIX)~1|HPV4~MERCK & CO. INC.~1311X~1~IM~UN~HPV (GARDASIL)~1|MNQ~SANOFI PASTEUR~U2928AA~1~IM~UN~MENINGOCOCCAL CONJUGATE (MENACTRA)~1|TDAP~SANOFI PASTEUR~C3098A~1~IM~UN~TDAP (ADACEL)~1	USA		Influenza
0360944	10/15/2009	NE	12.0	12		F	10/14/2009	Information has been received from a physician concerning a 13 year old female who in 2008 was vaccinated with GARDASIL. The patient completed the series of GARDASIL in 2008 and was recently diagnosed with Autoimmune Thyroiditis (2009). The patient sought her pediatrician. At the time of the reporting, the patient had not recovered from the event. Follow up information received on 06-OCT-2009 from a physician via medical records indicated that the patient was female student, with no medical history, known allergies or illness at the time of vaccination. The patient's family history included hypothyroidism and polycystic ovary syndrome (mother), aniridia (brother) and hypothyroidism (paternal grandmother). On 26-NOV-2008 the patient was vaccinated with a third dose of GARDASIL (lot # 650557/0072X), intramuscularly into the left arm. Secondary suspect vaccination given on the same day included a third dose of FLUZONE, (lot # U2760AA), intramuscularly into the right arm. The patient presented with her mother in the physician's office on 19-MAY-2009, complaining of feeling tired, muscle aches and requiring long naps. She has been experiencing these symptoms for the last couple of months (end of school year). The myalgias were generalized and most pronounced in her knees, hips and shoulders. TYLENOL helps some. She has been sleeping well-getting 8 hours of sleep without significant interruption. She generally feels well rested in the morning. She has not been short of breath and she denies fever, chills, night sweats, nausea, vomiting. She started her menstrual periods last July and they have been irregular. Her mother noticed that the fatigue and body aches were more pronounced just prior to her most recent menstruation. She had no urinary problems and she denied increase thirst. She grew approximately 2 inches in height in the past year. The physical exam was within normal limits. The patient developed hypothyroidism diagnosed on 19-MAY-2009 with symptoms beginning in March 2009 (approximate). The patient had a complete blood cell count, comprehensive metabolic panel and serum thyroid-stimulating hormone test drawn. All were normal except for serum thyroid-stimulating hormone test of 12.060 UIU/ml (high), normal 0.400-5.100, done on 19-MAY-2009. Patient's mother was notified and instructed to make an appointment with a child endocrinologist to evaluate hypothyroidism. The patient was not in any thyroid medication. On 30-JUL-2009, the patient was evaluated for hypothyroidism. There was no goiter. The patient's mother reported that the symptoms have somewhat improved despite no treatment. Patient scheduled for additional blood tests to evaluate need for her to start taking Levothyroxine. The reporting physician considered the hypothyroidism to be an other important medical event. No further information is available.				Y					N	11/26/2008			blood pressure, 114/5; serum TSH, 05/19/09, 12.06 UIU/, high; neutrophil count, 05/19/09, 53 %, lymphocyte count, 05/19/09, 36 %; monocyte count, 10 %; temperature measurement, 36.2 degrees C; respiratory rate, 18; total heartbeat count, 52; basophil count, 05/19/09, 0 %; eosinophil count, 05/19/09, 1 %; anion gap, 05/19/09, 20 mmol	PVT	PVT	Unknown		Unknown		WAES0908USA04293	1						1	Anion gap normal; Autoimmune thyroiditis; Basophil count decreased; Blood thyroid stimulating hormone increased; Body temperature; Eosinophil count normal; Fatigue; Hypothyroidism; Lymphocyte count normal; Menstruation irregular; Monocyte count increased; Myalgia; Neutrophil count decreased; Respiratory rate; Anion gap normal; Arthralgia; Autoimmune thyroiditis; Basophil percentage decreased; Blood thyroid stimulating hormone increased; Eosinophil count normal; Fatigue; Hypersomnia; Hypothyroidism; Lymphocyte count normal; Menstruation irregular; Monocyte percentage increased; Myalgia; Neutrophil percentage decreased; Pain	FLU3~SANOFI PASTEUR~U2760AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~1|HPV4~MERCK & CO. INC.~0072X~3~IM~LA~HPV (GARDASIL)~1|FLU3~SANOFI PASTEUR~U2760AA~3~IM~RA~INFLUENZA (SEASONAL) (FLUZONE)~2|HPV4~MERCK & CO. INC.~0072X~3~IM~LA~HPV (GARDASIL)~2	USA	Emergency room visit	Influenza
0360945	10/15/2009	AL	14.0	14		F	10/14/2009	Information has been received from a registered nurse concerning a 14 year old female who on 08-OCT-2009 was vaccinated with her second 0.5mL dose of GARDASIL (route and lot number not reported). Concomitant therapy included FLUMIST. IT was reported that half an hour later, on 08-OCT-2009, the patient experienced passed out, hit her head and had a seizure. The patient was taken to the emergency room and was released. The physician felt it was important to note that the patient had not eaten prior to vaccination. The patient recovered from hit her head, passed out and seizure on the same day. Follow up information was received from a registered nurse concerning the 14 year old female patient with no pertinent medical history reported and no known drug allergies who on 08-OCT-2009 was vaccinated with her second dose of GARDASIL (lot number 663451/0216Y) and concomitantly with a dose of FLUMIST (lot number 500711P). The registered nurse reported that the patient left the office and was in a restaurant when she passed out and stiffened on 08-OCT-2009. The patient was taken to the ER where a CT of the head, EKG, chest X-ray and blood work were performed (all normal). No treatment was needed. It was noted that the patient received the first dose of GARDASIL (route not reported, lot number 664780/0904Y, valid for ROTATEQ) on 16-JUL-2009. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.				Y					Y	10/08/2009	10/08/2009	0	electrocardiogram, 10/08/09, Normal; chest X-ray, 10/08/09, Normal; head computed axial, 10/08/09, Normal; diagnostic laboratory, 10/08/09, Blood work: Normal	OTH	OTH			None		WAES0910USA00980	1						1	Blood test normal; Chest X-ray normal; Computerised tomogram head; Computerised tomogram normal; Convulsion; Electrocardiogram normal; Head injury; Loss of consciousness; Musculoskeletal stiffness	FLUN3~MEDIMMUNE VACCINES, INC.~500711P~UNK~IN~NS~INFLUENZA (SEASONAL) (FLUMIST)~1|HPV4~MERCK & CO. INC.~0216Y~2~UN~UN~HPV (GARDASIL)~1	USA	Emergency room visit	Influenza
0360950	10/15/2009	VA				F	10/06/2009	9 hrs post injection, fever 103 for day and half, sore eyes, cough & body ache.									Y	10/04/2009	10/04/2009	0		PVT	PVT						1						1	Cough; Eye pain; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U3214AA~UNK~IJ~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360951	10/15/2009	VA	6.0	6		M	10/06/2009	5 hours post injection fever 103 degrees persisting for 2 days, sore eyes and body aches wit.h dry cough. Still fever at time of report.									N	10/04/2009	10/04/2009	0		PVT	PVT	None	None	None			1						1	Cough; Eye pain; Pain; Pyrexia	FLU3~SANOFI PASTEUR~U3214AA~1~UN~LA~INFLUENZA (SEASONAL) (FLUZONE)~1	USA		Influenza
0360953	10/15/2009	FL	36.0	36		F	10/15/2009	Client c/o nausea immediately following the shot, headache 2 1/2 hrs after and dizziness 3 1/2 hrs after, felt fast heart rate which lasted for 15 mins, numbness (L) breast, had on 3 pillows last night. Did not take any meds. Is still c/o slight dizziness today. Patient recovering still c/o slight nausea and dizziness.										10/14/2009	10/14/2009	0	None	PUB	OTH		None				1						1	Dizziness; Headache; Heart rate increased; Hypoaesthesia; Immediate post-injection reaction; Nausea	FLU(H1N1)~SANOFI PASTEUR~UP009AA~1~IM~LA~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI))~1	USA		Influenza
0360954	10/15/2009	PA	36.0	36		F	10/15/2009	Five minutes after receiving injectable H1N1 vaccine, developed dry cough & generalized itching.										10/15/2009	10/15/2009	0		UNK	UNK	Birthcontrol pill;  Retin-A	None	GERD;  Acne			1						1	Cough; Pruritus generalised	FLU(H1N1)~SANOFI PASTEUR~UP002AA~1~IM~RA~INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI))~1	USA		Influenza
0360955	10/15/2009	PA	49.0	49		M	10/09/2009	I had an extreme reaction with sever Flu like symptoms - light/sound sensitive, front headach, total body achs sore - high Fever, chills, sweating on 2nd day.									Y	10/05/2009	10/06/2009	1	N/A	OTH	OTH		None	Hepatitis C - S/P Interferon/Ribavirin - no detectible virus			1						1	Chills; Headache; Hyperhidrosis; Immunisation reaction; Influenza like illness; Pain; Phonophobia; Photophobia; Pyrexia	FLU3~CSL LIMITED~O8449111A~4~IM~RA~INFLUENZA (SEASONAL) (AFLURIA)~1|PPV~MERCK & CO. INC.~1134Y~2~IM~LA~PNEUMO (PNEUMOVAX)~1	USA		Influenza
0360956	10/15/2009	MD	49.0	49		F	10/15/2009	Pt reported swelling, fiery red rash, itching and soreness peri-injection site approx 48 hours after receiving injection. Pt states she took BENADRYL at time reported - rash resolving.									Y	10/07/2009	10/09/2009	2		PVT	OTH	Zolpidem 10 mg; FLUTICASONE nasal spray 16 mg; Hydrochlorothiazide 25 mg; ADVAIR discus 250/50; Albuterol Sol 2.5 mg; LOESTRIN 24 FE Provide; Alprazolam 5 mg; EFFEXOR XR 75 mg; Fexofenadine 180 mg; Pro air HFA 9 mg; Gabapentin 300mg one cap	Asthma	PCN			1						1	Injection site pain; Injection site pruritus; Injection